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Sample records for market surveillance tests

  1. 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.

  2. 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.

  3. [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.

  4. 75 FR 17174 - Market Test

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-05

    ... Market Test AGENCY: Postal Regulatory Commission. ACTION: Notice. SUMMARY: The Commission is noticing a recently-filed Postal Service notice announcing its intent to initiate a market test. This notice addresses...), announcing its intent to initiate a market test beginning on or about May 1, 2010, of an experimental...

  5. Risk effectiveness evaluation of surveillance testing

    SciTech Connect

    Martorell, S.; Kim, I.S.; Samanta, P.K.; Vesely, W.E.

    1992-07-20

    In nuclear power plants surveillance tests are required to detect failures in standby safety system components as a means of assuring their availability in case of an accident. However, the performance of surveillance tests at power may have adverse impact on safety as evidenced by the operating experience of the plants. The risk associated with a test includes two different aspects: (1) a positive aspect, i.e., risk contribution detected by the test, that results from the detection of failures which occur between tests and are detected by the test, and (2) a negative aspect, i.e., risk contribution caused by the test, that includes failures and degradations which are caused by the test or are related to the performance of the test. In terms of the two different risk contributions, the risk effectiveness of a test can be simply defined as follows: a test is risk effective if the risk contribution detected by the test is greater than the risk contribution caused by the test; otherwise it is risk ineffective. The methodology presentation will focus on two important kinds of negative test risk impacts, that is, the risk impacts of test-caused transients and equipment wear-out. The evaluation results of the risk effectiveness of the test will be presented in the full paper along with the risk assessment methodology and the insights from the sensitivity analysis. These constitute the core of the NUREG/CR-5775.

  6. The Yoruba farm market as a communication channel in guinea worm disease surveillance.

    PubMed

    Brieger, W R; Kendall, C

    1996-01-01

    Disease eradication programmes are by definition time bound and require strategies that facilitate timely intervention. Surveillance, which undergirds eradication, also requires timely strategies. Finding such strategies is especially challenging when the target disease is endemic in remote areas, e.g. guinea worm disease, the focus of this study. A strategy of market based surveillance was pilot tested in Ifeloju Local Government Area (LGA) of Oyo State, Nigeria. The project goal was to design a surveillance system that both fit into the natural communication network of rural people, and also enlisted their active involvement. Ethnographic research methods were employed to learn about market location, structure, catchment area and attendance pattern. Four larger farm markets (serving 164 hamlets with 17,000 population) were chosen. Each hamlet was visited and a volunteer 'reporter' was recruited. Reporters were trained on case recognition and detection, first aid and prevention, with a sensitivity to distinguishing indigenous and clinical perceptions of guinea worm. The market cycle was based on the traditional four-day week. Field workers visited every second market 16 times between October 1990 and February 1991. The reporter was expected to identify correctly the first case of the season and thus label the village as endemic for the season. Reporters gave oral reports, and positive indications were followed up within 48 hr by field workers, who verified the case and administered first aid. All hamlets were visited once a month to verify negative reports. Reporter attendance was monitored. Those who had a formal role in the market, e.g. sales agents, had better attendance than ordinary farmers who came only to sell their own produce. Knowledge of market structure and attender roles offers a guide for adapting this surveillance approach to other cultural systems and health issues.

  7. 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.

  8. [Marketing approval and market surveillance of medical devices in Germany: Where does policy integration take place?].

    PubMed

    Lang, Achim

    2014-01-01

    Since 2011 new regulatory measures regarding medical devices have been set up with the aim to eliminate obstacles to innovations and to find more coordinated ways to marketing authorisation and market surveillance. This essay investigates whether these new and existing coordination mechanisms build up to a Joined-up Government approach. The analysis shows that the regulatory process should be adjusted along several dimensions. First, many organisations lack awareness regarding their stakeholders and focus solely on their immediate organisational activities. Second, the regulatory process (marketing authorisation and market surveillance) is too fragmented for an effective communication to take place. Finally, the underlying strategy process is an ad-hoc approach lacking continuity and continued involvement of, in particular, the responsible federal ministries. Copyright © 2013. Published by Elsevier GmbH.

  9. A composite CBRN surveillance and testing service

    NASA Astrophysics Data System (ADS)

    Niemeyer, Debra M.

    2004-08-01

    The terrorist threat coupled with a global military mission necessitates quick and accurate identification of environmental hazards, and CBRN early warning. The Air Force Institute for Operational Health (AFIOH) provides fundamental support to protect personnel from and mitigate the effects of untoward hazards exposures. Sustaining healthy communities since 1955, the organizational charter is to enhance warfighter mission effectiveness, protect health, improve readiness and reduce costs, assess and manage risks to human heath and safety, operational performance and the environment. The AFIOH Surveillance Directorate provides forward deployed and reach-back surveillance, agent identification, and environ-mental regulatory compliance testing. Three unique laboratories process and analyze over two million environmental samples and clinical specimens per year, providing analytical chemistry, radiological assessment, and infectious disease testing, in addition to supporting Air Force and Department of Defense (DoD) clinical reference laboratory and force health protection testing. Each laboratory has an applied or investigational testing section where new technologies and techniques are evaluated, and expert consultative support to assist in technology assessments and test analyses. The Epidemiology Surveillance Laboratory and Analytical Chemistry Laboratory are critical assets of the Centers for Disease Control and Prevention (CDC) National Laboratory Response Network. Deployable assets provide direct support to the Combatant Commander and include the Air Force Radiological Assessment Team, and the Biological Augmentation Team. A diverse directorate, the synergistic CBRN response capabilities are a commander"s force protection tool, critical to maintaining combat power.

  10. 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.

  11. 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.

  12. Ability Tests, Measurements, and Markets.

    ERIC Educational Resources Information Center

    Sternberg, Robert J.

    1992-01-01

    Progress, or lack thereof, in the development of ability testing is reviewed. Current tests, though inadequate, respond to the demands of test consumers. Test publishers must look ahead to changing demands and begin to lead the market, rather than follow it, by drawing on basic research in testing. (SLD)

  13. 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.

  14. 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.

  15. Evaluating a surveillance system: live-bird market surveillance for highly pathogenic avian influenza, a case study.

    PubMed

    Waziri, Ndadilnasiya Endie; Nguku, Patrick; Olayinka, Adebola; Ajayi, Ike; Kabir, Junaidu; Okolocha, Emmanuel; Tseggai, Tesfai; Joannis, Tony; Okewole, Phillip; Kumbish, Peterside; Ahmed, Mohammed; Lombin, Lami; Nsubuga, Peter

    2014-01-01

    Highly pathogenic avian influenza H5N1 was first reported in poultry in Nigeria in February 2006. The only human case that occurred was linked to contact with poultry in a live bird market (LBM). LBM surveillance was instituted to assess the degree of threat of human exposure to H5N1. The key indicator was detection of H5N1 in LBMs. We evaluated the surveillance system to assess its operations and attributes. We used the US Centers for Disease Control and Prevention (CDC) updated guidelines for evaluating public health surveillance systems. We reviewed and analyzed passive surveillance data for HPAI (January 2006-March 2009) from the Avian Influenza National Reference Laboratory, and live bird market surveillance data from the Food and Agriculture Organization of the United Nations, Nigeria. We interviewed key stakeholders and reviewed reports of live bird market surveillance to obtain additional information on the operations of the system. We assessed the key system attributes. A total of 299 cases occurred in 25 (72%) states and the Federal Capital Territory (FCT). The system detected HPAI H5N1 virus in 7 (9.5%) LBMs; 2 (29%) of which were from 2 (18.2%) states with no previous case. A total of 17,852 (91.5%) of samples arrived at the laboratory within 24 hours but laboratory analysis took over 7 days. The sensitivity and positive predictive value (PPV) were 15.4% and 66.7% respectively. The system is useful, flexible, complex and not timely, but appears to be meeting its objectives. The isolation of HPAI H5N1 virus in some of these markets is an indication that the markets are possible reservoirs of the virus in Nigeria. We recommend that the Federal Government of Nigeria should dedicate more funds for surveillance for HPAI as this will aid early warning and reduce the risk of a pandemic.

  16. 76 FR 3679 - Market Test of Marketing Mail Made Easy

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-20

    ... Market Test of Marketing Mail Made Easy AGENCY: Postal Regulatory Commission. ACTION: Notice. SUMMARY: The Commission is noticing a recently-filed Postal Service proposal to conduct a 2-year market test... Service filed a notice, pursuant to 39 U.S.C. 3641, announcing its intent to initiate a market test of an...

  17. 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

  18. 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.

  19. Assessing alternative low pathogenic avian influenza virus surveillance strategies in a live bird market.

    PubMed

    Carpenter, Tim E; Cardona, Carol

    2012-12-01

    Surveillance, comprised of sampling and testing, of low pathogenic avian influenza virus (LPAIV) in a live bird market (LBM) may enable the detection of the virus, reducing its spread within the market to humans and birds and to other markets within the LBM system. In addition, detection of infected birds would also reduce the probability of reassortment and possible change from a LPAIV to a highly pathogenic avian influenza virus, which would have a devastating impact on the economy, trade, and society. In this paper we present results from a computer simulation model based on previously collected survey and experimental transmission data. Once we validated the model with experimental transmission data, we applied it to address some of the questions that need to be answered in order to create an efficient surveillance system in an LBM. We have identified effective sampling times, patterns, and sizes that would enhance the probability of an early detection of LPAIV if present and minimize the associated labor and cost. The model may be modified to evaluate different sized and structured LBMs. It also provides the basis to evaluate an entire LBM system for the United States or other countries.

  20. 2003 Nevada Test Site Annual Illness and Injury Surveillance Report

    SciTech Connect

    U.S. Department of Energy, Office of Health, Safety and Security, Office of Illness and Injury Prevention Programs

    2007-05-23

    Annual Illness and Injury Surveillance Program report for 2003 for the Nevada Test Site. The U.S. Department of Energy’s (DOE) commitment to assuring the health and safety of its workers includes the conduct of epidemiologic surveillance activities that provide an early warning system for health problems among workers. The Illness and Injury Surveillance Program monitors illnesses and health conditions that result in an absence of workdays, occupational injuries and illnesses, and disabilities and deaths among current workers.

  1. Test Marketing in New Product Development

    ERIC Educational Resources Information Center

    Klompmaker, Jay E.; And Others

    1976-01-01

    Discusses the role of test marketing in new product development, based on interviews with marketing executives. Attempts to clarify when a test market should be done, what its aims should be, and how it should be used. (JG)

  2. Test Marketing in New Product Development

    ERIC Educational Resources Information Center

    Klompmaker, Jay E.; And Others

    1976-01-01

    Discusses the role of test marketing in new product development, based on interviews with marketing executives. Attempts to clarify when a test market should be done, what its aims should be, and how it should be used. (JG)

  3. Laboratory test surveillance following acute kidney injury.

    PubMed

    Matheny, Michael E; Peterson, Josh F; Eden, Svetlana K; Hung, Adriana M; Speroff, Theodore; Abdel-Kader, Khaled; Parr, Sharidan K; Ikizler, T Alp; Siew, Edward D

    2014-01-01

    Patients with hospitalized acute kidney injury (AKI) are at increased risk for accelerated loss of kidney function, morbidity, and mortality. We sought to inform efforts at improving post-AKI outcomes by describing the receipt of renal-specific laboratory test surveillance among a large high-risk cohort. We acquired clinical data from the Electronic health record (EHR) of 5 Veterans Affairs (VA) hospitals to identify patients hospitalized with AKI from January 1st, 2002 to December 31st, 2009, and followed these patients for 1 year or until death, enrollment in palliative care, or improvement in renal function to estimated GFR (eGFR) ≥ 60 L/min/1.73 m(2). Using demographic data, administrative codes, and laboratory test data, we evaluated the receipt and timing of outpatient testing for serum concentrations of creatinine and any as well as quantitative proteinuria recommended for CKD risk stratification. Additionally, we reported the rate of phosphorus and parathyroid hormone (PTH) monitoring recommended for chronic kidney disease (CKD) patients. A total of 10,955 patients admitted with AKI were discharged with an eGFR<60 mL/min/1.73 m2. During outpatient follow-up at 90 and 365 days, respectively, creatinine was measured on 69% and 85% of patients, quantitative proteinuria was measured on 6% and 12% of patients, PTH or phosphorus was measured on 10% and 15% of patients. Measurement of creatinine was common among all patients following AKI. However, patients with AKI were infrequently monitored with assessments of quantitative proteinuria or mineral metabolism disorder, even for patients with baseline kidney disease.

  4. Laboratory Test Surveillance following Acute Kidney Injury

    PubMed Central

    Matheny, Michael E.; Peterson, Josh F.; Eden, Svetlana K.; Hung, Adriana M.; Speroff, Theodore; Abdel-Kader, Khaled; Parr, Sharidan K.; Ikizler, T. Alp; Siew, Edward D.

    2014-01-01

    Background Patients with hospitalized acute kidney injury (AKI) are at increased risk for accelerated loss of kidney function, morbidity, and mortality. We sought to inform efforts at improving post-AKI outcomes by describing the receipt of renal-specific laboratory test surveillance among a large high-risk cohort. Methods We acquired clinical data from the Electronic health record (EHR) of 5 Veterans Affairs (VA) hospitals to identify patients hospitalized with AKI from January 1st, 2002 to December 31st, 2009, and followed these patients for 1 year or until death, enrollment in palliative care, or improvement in renal function to estimated GFR (eGFR) ≥60 L/min/1.73 m2. Using demographic data, administrative codes, and laboratory test data, we evaluated the receipt and timing of outpatient testing for serum concentrations of creatinine and any as well as quantitative proteinuria recommended for CKD risk stratification. Additionally, we reported the rate of phosphorus and parathyroid hormone (PTH) monitoring recommended for chronic kidney disease (CKD) patients. Results A total of 10,955 patients admitted with AKI were discharged with an eGFR<60 mL/min/1.73 m2. During outpatient follow-up at 90 and 365 days, respectively, creatinine was measured on 69% and 85% of patients, quantitative proteinuria was measured on 6% and 12% of patients, PTH or phosphorus was measured on 10% and 15% of patients. Conclusions Measurement of creatinine was common among all patients following AKI. However, patients with AKI were infrequently monitored with assessments of quantitative proteinuria or mineral metabolism disorder, even for patients with baseline kidney disease. PMID:25117447

  5. 76 FR 74078 - Standard Mail Market Test

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-30

    ... Standard Mail Market Test AGENCY: Postal Regulatory Commission. ACTION: Notice. SUMMARY: The Commission is... that applies to market tests of experimental market dominant products. It seeks the exemption for Every... exemption from the $10,000,000 revenue limitation in any year during the test of an experimental market...

  6. 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.

  7. 77 FR 26674 - Enhancement of Electricity Market Surveillance and Analysis Through Ongoing Electronic Delivery...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-07

    ... Energy Regulatory Commission 18 CFR Part 35 Enhancement of Electricity Market Surveillance and Analysis... ensure just and reasonable rates. \\1\\ 16 U.S.C. 825(b), 825f(a). II. Background 2. Wholesale electricity... consumers.\\4\\ \\2\\ A more in-depth discussion of developments in wholesale electricity markets--which no...

  8. Evaluation of Kenya's readiness to transition from sentinel surveillance to routine HIV testing for antenatal clinic-based HIV surveillance.

    PubMed

    Sirengo, Martin; Rutherford, George W; Otieno-Nyunya, Boaz; Kellogg, Timothy A; Kimanga, Davies; Muraguri, Nicholas; Umuro, Mamo; Mirjahangir, Joy; Stein, Ellen; Ndisha, Margaret; Kim, Andrea A

    2016-03-05

    Sentinel surveillance for HIV among women attending antenatal clinics using unlinked anonymous testing is a cornerstone of HIV surveillance in sub-Saharan Africa. Increased use of routine antenatal HIV testing allows consideration of using these programmatic data rather than sentinel surveillance data for HIV surveillance. To gauge Kenya's readiness to discontinue sentinel surveillance, we evaluated whether recommended World Health Organization standards were fulfilled by conducting data and administrative reviews of antenatal clinics that offered both routine testing and sentinel surveillance in 2010. The proportion of tests that were HIV-positive among women aged 15-49 years was 6.2% (95% confidence interval [CI] 4.6-7.7%] in sentinel surveillance and 6.5% (95% CI 5.1-8.0%) in routine testing. The agreement of HIV test results between sentinel surveillance and routine testing was 98.0%, but 24.1% of specimens that tested positive in sentinel surveillance were recorded as negative in routine testing. Data completeness was moderate, with HIV test results recorded for 87.8% of women who received routine testing. Additional preparation is required before routine antenatal HIV testing data can supplant sentinel surveillance in Kenya. As the quality of program data has markedly improved since 2010 a repeat evaluation of the use of routine antenatal HIV testing data in lieu of ANC sentinel surveillance is recommended.

  9. [Surveillance of radioactive cesium in domestic foods on the Japanese market (Fiscal Years 2012 and 2013)].

    PubMed

    Uekusa, Yoshinori; Nabeshi, Hiromi; Nakamura, Rika; Tsutsumi, Tomoaki; Hachisuka, Akiko; Matsuda, Rieko; Teshima, Reiko

    2015-01-01

    We surveyed the concentration of radioactive cesium in foods purchased at markets in areas where possible contamination has been a concern after the Fukushima accident. In fiscal years 2012 and 2013, we surveyed 1,735 and 1,674 foods, respectively, using a NaI (Tl) scintillation spectrometer for the screening test and a γ-ray spectrometer with a germanium semiconductor detector for the final test. Only 3 and 4 samples (0.2% of our total samples) exceeded the regulatory limit (100 Bq/kg) for radioactive cesium in fiscal years 2012 and 2013, respectively. Our surveillance indicates that the pre-shipment monitoring of foods by local governments has been working effectively.

  10. Monitoring risk: post marketing surveillance and signal detection.

    PubMed

    Dart, Richard C

    2009-12-01

    The primary goal of postmarketing surveillance is to provide information for risk assessment of a drug. Drugs affecting the central nervous system form a unique group of products for surveillance because they are often misused, abused, and diverted. These medications include opioid analgesics, stimulants, sedative-hypnotics, muscle relaxants, anticonvulsants and other drug classes. Their adverse events are difficult to monitor because the perpetrator often attempts to conceal the misuse, abuse and diversion of the product. A postmarketing surveillance system for prescription drugs of abuse in the U.S. should include product specific information that is accurate, immediately available, geographically specific and includes all areas of the country. Most producers of branded opioid analgesic products have created systems that measure abuse from multiple vantage points: criminal justice, treatment professionals, susceptible patient populations and acute health events. In the past, the U.S. government has not established similar requirements for the same products produced by generic manufacturers. However, the Food and Drug Administration Amendments Act of 2007 includes generic opioid analgesic products by requiring that all products containing potent opioid drugs perform rigorous surveillance and risk management. While general risk management guidance has been developed by FDA, more specific analyses and guidance are needed to improve surveillance methodology for drugs which are misused, abused, diverted.

  11. Patulin surveillance in apple cider and juice marketed in Michigan.

    PubMed

    Harris, Kerri L; Bobe, Gerd; Bourquin, Leslie D

    2009-06-01

    Patulin is the most common mycotoxin found in apples and apple juices. The objective of this study was to determine the concentrations of patulin in (i) apple cider produced and marketed by Michigan apple cider mills during the fall seasons of 2002 to 2003 and 2003 to 2004 and (ii) apple juice and cider, including shelf-stable products, marketed in retail grocery stores in Michigan throughout 2005 and 2006. End product samples (n=493) obtained from 104 Michigan apple cider mills were analyzed for patulin concentration by using solid-phase extraction followed by high-performance liquid chromatography. Patulin was detected (> or =4 microg/liter) in 18.7% of all cider mill samples, with 11 samples (2.2%) having patulin concentrations of > or =50 microg/liter. A greater percentage of cider samples obtained from mills using thermal pasteurization contained detectable patulin (28.4%) than did those from mills using UV light radiation (13.5%) or no pathogen reduction treatment (17.0%). Among retail grocery store samples (n=159), 23% of apple juice and cider samples contained detectable patulin, with 18 samples (11.3%) having patulin concentrations of > or =50 microg/liter. The U.S. Food and Drug Administration (FDA) action level for patulin is 50 microg/kg. Some apple juice samples obtained from retail grocery stores had exceptionally high patulin concentrations, ranging up to 2700 microg/liter. Collectively, these results indicate that most apple cider and juice test samples from Michigan were below the FDA action level for patulin but that certain apple cider and juice processors have inadequate controls over patulin concentrations in final products. The industry, overall, should focus on improved quality of fruit used in juice production and improve culling procedures to reduce patulin concentrations.

  12. 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.

  13. Bangladesh SMP test markets ORS.

    PubMed

    1984-01-01

    The Bangladesh Social Marketing Program (SMP) is completing test marketing of a US-manufactured oral rehydration salt (ORS) called "Orasaline," according to William Schellstede, resident advisor with Population Services International (PSI), the project's technical contractor. While the results have not yet been assessed, Schellstede says about 45,000 sachets have been sold throughout the country's 8 sales districts since the test marketing began several months ago. Each sachet contains 14 g of orasaline and makes 500 cc of prepared solution. The ORS product was made available through a grant from the Ford Foundation to PSI to determine the public health impact of selling Orasaline at full cost. Its 5 taka ($.20 US) consumer price covers raw material, manufacturing, distribution, and promotion costs. "Both the general retailers and rural medical practitioners responded favorably to the product and found its use easily explained," Schellstede says. "About 60% of them bought the product and 48% have already placed orders for more. In 3 or 4 of the sales areas, the SMP's stocks were exhausted." However, he expects the test results to show that a subsidized ORS product would greatly intensify its public health impact by allowing a much lower consumer price. "Cheaper ORS products, often bootlegged from free sources are available in the country," explains Schellstede. The SMP is negotiating with Norway's governmental aid agency, NORAD, for donated ORS packets, he adds. ORS sales represent the SMP's 2nd expansion of its product line in the past year. In cooperation with the Bangladesh government, the SMP previously introduced a "safe delivery kit" to help midwives reduce infant and maternal mortality, tetanus, and other birth-related diseases.

  14. 76 FR 25381 - Postal Service Market Test

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-04

    ... Postal Service Market Test AGENCY: Postal Regulatory Commission. ACTION: Notice. SUMMARY: The Commission... Logistics experimental market test, pending Commission action on anticipated request for permanent status... Postal Service moved to temporarily extend its Collaborative Logistics market test under 39 U.S.C. 3641(d...

  15. 76 FR 22739 - Postal Service Market Test

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-22

    ... Postal Service Market Test AGENCY: Postal Regulatory Commission. ACTION: Notice. SUMMARY: The Commission is noticing a recently-filed Postal Service proposal to conduct a limited market test involving a... test of an experimental market dominant product identified as Mail Works Guarantee.\\1\\ The Postal...

  16. 21 CFR 822.28 - If I stop marketing the device subject to postmarket surveillance, what must I do?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... postmarket surveillance, what must I do? 822.28 Section 822.28 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Responsibilities of Manufacturers § 822.28 If I stop marketing the device subject to postmarket surveillance, what...

  17. 21 CFR 822.28 - If I stop marketing the device subject to postmarket surveillance, what must I do?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... postmarket surveillance, what must I do? 822.28 Section 822.28 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Responsibilities of Manufacturers § 822.28 If I stop marketing the device subject to postmarket surveillance, what...

  18. 21 CFR 822.28 - If I stop marketing the device subject to postmarket surveillance, what must I do?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... postmarket surveillance, what must I do? 822.28 Section 822.28 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Responsibilities of Manufacturers § 822.28 If I stop marketing the device subject to postmarket surveillance, what...

  19. Potential metal impurities in active pharmaceutical substances and finished medicinal products - A market surveillance study.

    PubMed

    Wollein, Uwe; Bauer, Bettina; Habernegg, Renate; Schramek, Nicholas

    2015-09-18

    A market surveillance study has been established by using different atomic spectrometric methods for the determination of selected elemental impurities of particular interest, to gain an overview about the quality of presently marketed drug products and their bulk drug substances. The limit tests were carried out with respect to the existing EMA guideline on the specification limits for residuals of metal catalysts or metal reagents. Also attention was given to the future implementation of two new chapters of the United States Pharmacopoeia (USP) stating limit concentrations of elemental impurities. The methods used for determination of metal residues were inductively coupled plasma-mass spectrometry (ICP-MS), inductively coupled plasma-optical emission spectrometry (ICP-OES), and atomic absorption spectrometry technologies (GFAAS, CVAAS, HGAAS). This article presents the development and validation of the methods used for the determination of 21 selected metals in 113 samples from drug products and their active pharmaceutical ingredients. Copyright © 2015 Elsevier B.V. All rights reserved.

  20. Respect versus Surveillance: Drug Testing Our Students

    ERIC Educational Resources Information Center

    Brendtro, Larry K.; Martin, Gordon A., Jr.

    2006-01-01

    This launches a new periodic feature in Reclaiming Children and Youth. "Justice Alerts" examines current laws and policies against the twofold standards of solid science and moral values. This inaugural article explores the legal issues and political rhetoric surrounding random drug testing in schools and describes how science is being…

  1. Respect versus Surveillance: Drug Testing Our Students

    ERIC Educational Resources Information Center

    Brendtro, Larry K.; Martin, Gordon A., Jr.

    2006-01-01

    This launches a new periodic feature in Reclaiming Children and Youth. "Justice Alerts" examines current laws and policies against the twofold standards of solid science and moral values. This inaugural article explores the legal issues and political rhetoric surrounding random drug testing in schools and describes how science is being…

  2. 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.

  3. 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.

  4. Standards for reporting surveillance information in freedom from infection models by example of Trichinella in Canadian market hogs.

    PubMed

    Vanderstichel, Raphaël; Christensen, Jette; Stryhn, Henrik; Hurnik, Daniel

    2013-08-01

    Freedom from infection modeling, using scenario trees, has become an established methodology and is well described in the literature. However, standards for organizing and reporting the surveillance information incorporated into such models are less developed. Canada has been routinely testing for Trichinella spiralis in market hogs in federally inspected slaughter plants since the late 1990s. By way of presenting our work on T. spiralis in Canadian hogs, we propose that information in surveillance models be organized in distinct categories, each with specific parameters and values that are thoroughly described and justified. The proposed categories are: (1) definitions for the objectives, (2) initial time period, (3) inputs, (4) data, (5) model settings, (6) outputs, and (7) validation. Having a standardized manner of reporting such studies will facilitate their validation and expedite their evaluation by experts in the field and their use in trade negotiations.

  5. Hepatoxicity associated with weight-loss supplements: A case for better post-marketing surveillance

    PubMed Central

    Lobb, Ano

    2009-01-01

    There is a growing number of case reports of hepatoxicity from the widely marketed weight-loss supplement Hydroxycut, which contains the botanical ingredient Garcinia cambogia. These case reports may substantially undercount the true magnitude of harm. Based on the past experience with harmful dietary supplements, US regulators should assume the more precautionary approach favored by Canada and Europe. Lacking effective adverse event surveillance for supplements, or the requirements to prove safety prior to coming to the market, case reports such as those summarized here assume added importance. PMID:19360927

  6. Hepatoxicity associated with weight-loss supplements: a case for better post-marketing surveillance.

    PubMed

    Lobb, Ano

    2009-04-14

    There is a growing number of case reports of hepatoxicity from the widely marketed weight-loss supplement Hydroxycut, which contains the botanical ingredient Garcinia cambogia. These case reports may substantially undercount the true magnitude of harm. Based on the past experience with harmful dietary supplements, US regulators should assume the more precautionary approach favored by Canada and Europe. Lacking effective adverse event surveillance for supplements, or the requirements to prove safety prior to coming to the market, case reports such as those summarized here assume added importance.

  7. Testing for nonlinear dependence in financial markets.

    PubMed

    Dore, Mohammed; Matilla-Garcia, Mariano; Marin, Manuel Ruiz

    2011-07-01

    This article addresses the question of improving the detection of nonlinear dependence by means of recently developed nonparametric tests. To this end a generalized version of BDS test and a new test based on symbolic dynamics are used on realizations from a well-known artificial market for which the dynamic equation governing the market is known. Comparisons with other tests for detecting nonlinearity are also provided. We show that the test based on symbolic dynamics outperforms other tests with the advantage that it depends only on one free parameter, namely the embedding dimension. This does not hold for other tests for nonlinearity.

  8. [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

  9. [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.

  10. 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.

  11. Results of a market surveillance study in The Netherlands on break-mark tablets.

    PubMed

    Barends, D M; Groot, D W; van der Steen, J C; de Kaste, D; Frijlink, H W

    2006-12-01

    A representative market surveillance study on break-mark tablets for human use, having a marketing authorization (MA) in The Netherlands (NL), was carried out. The uniformity of mass of subdivided break-mark tablets into halves was assessed according to Ph.Eur.5.5, now current; and for comparison also according to Ph.Eur. 4.1 (no longer in force) and Pharmeuropa 16.2. The compliance was 24%, 14% and 45%, respectively. The compliance with a criterion for loss of mass by subdivision of break-mark tablets (< or = 1.0% of the total mass) was 86%. The compliance with a criterion for ease of subdivision of break-mark tablets (> or = 80% of a panel of elderly able to break, > or = 90% probability) was 34%. Of the 29 studied tablets, 5 complied with all criteria, amongst which were all three oblong tablets that were included in the study. The Summary of Product Characteristics (SmPC) of the tablets was independently evaluated by experts to assess whether their break-mark was needed for the posology. The experts came to a uniform conclusion for only 66% of the tablets. It is concluded that the proposed test procedures for ease of subdivision and loss of mass by subdivision are workable, that the proposed criteria are reasonable and that their inclusion in Ph.Eur. can be considered. From a pharmaceutical-technological point of view, the requirements of Ph.Eur. 5.5 Subdivision of tablets for uniformity of mass of subdivided tablets, and the proposed criteria for ease of subdivision and loss of mass, are all simultaneously attainable. It is also concluded that the majority of the break-mark tablets with a MA in NL do not meet the requirements of Ph.Eur.5.5 Subdivision of tablets, and that they do not fulfill the proposed criterion for ease of subdivision. This is expected to also be the case in other countries. It is proposed that the test Ph.Eur. 5.5 Subdivision of tablets should give instructions on how to handle tablets that cannot be broken, or that crumble upon

  12. 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.

  13. Is it time for NESST (National Egg Salmonella Surveillance Testing)?

    USDA-ARS?s Scientific Manuscript database

    The logistics required for a National Egg Salmonella sampling Testing (NESST) project are described. Market egg sampling data has never been collected in the United States on a national basis and no regional sampling data has been collected in 10 years. Salmonella outbreaks continue to be attribute...

  14. Active surveillance for carbapenem-resistant Enterobacteriaceae using stool specimens submitted for testing for Clostridium difficile.

    PubMed

    Banach, David B; Francois, Jeannette; Blash, Stephanie; Patel, Gopi; Jenkins, Stephen G; LaBombardi, Vincent; Kreiswirth, Barry N; Srinivasan, Arjun; Calfee, David P

    2014-01-01

    Active surveillance to identify asymptomatic carriers of carbapenem-resistant Enterobacteriaceae (CRE) is a recommended strategy for CRE control in healthcare facilities. Active surveillance using stool specimens tested for Clostridium difficile is a relatively low-cost strategy to detect CRE carriers. Further evaluation of this and other risk factor-based active surveillance strategies is warranted.

  15. Surveillance System and Method having an Adaptive Sequential Probability Fault Detection Test

    NASA Technical Reports Server (NTRS)

    Bickford, Randall L. (Inventor); Herzog, James P. (Inventor)

    2008-01-01

    System and method providing surveillance of an asset such as a process and/or apparatus by providing training and surveillance procedures that numerically fit a probability density function to an observed residual error signal distribution that is correlative to normal asset operation and then utilizes the fitted probability density function in a dynamic statistical hypothesis test for providing improved asset surveillance.

  16. Surveillance system and method having an adaptive sequential probability fault detection test

    NASA Technical Reports Server (NTRS)

    Herzog, James P. (Inventor); Bickford, Randall L. (Inventor)

    2005-01-01

    System and method providing surveillance of an asset such as a process and/or apparatus by providing training and surveillance procedures that numerically fit a probability density function to an observed residual error signal distribution that is correlative to normal asset operation and then utilizes the fitted probability density function in a dynamic statistical hypothesis test for providing improved asset surveillance.

  17. Surveillance system and method having an adaptive sequential probability fault detection test

    NASA Technical Reports Server (NTRS)

    Bickford, Randall L. (Inventor); Herzog, James P. (Inventor)

    2006-01-01

    System and method providing surveillance of an asset such as a process and/or apparatus by providing training and surveillance procedures that numerically fit a probability density function to an observed residual error signal distribution that is correlative to normal asset operation and then utilizes the fitted probability density function in a dynamic statistical hypothesis test for providing improved asset surveillance.

  18. 76 FR 71610 - Market Test of First-Class Tracer

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-18

    ... Market Test of First-Class Tracer AGENCY: Postal Regulatory Commission. ACTION: Notice. SUMMARY: The Commission is noticing a recently-field Postal Service proposal to conduct a market test of a market dominant... a market test beginning on or about December 7, 2011, of an experimental market dominant product...

  19. LWR surveillance dosimetry improvement program: PSF metallurgical blind test results

    SciTech Connect

    Kam, F.B.K.; Maerker, R.E.; Stallmann, F.W.

    1984-01-01

    The metallurgical irradiation experiment at the Oak Ridge Research Reactor Poolside Facility (ORR-PSF) was designed as a benchmark to test the accuracy of radiation embrittlement predictions in the pressure vessel wall of light water reactors on the basis of results from surveillance capsules. The PSF metallurgical Blind Test is concerned with the simulated surveillance capsule (SSC) and the simulated pressure vessel capsule (SPVC). The data from the ORR-PSF benchmark experiment are the basis for comparison with the predictions made by participants of the metallurgical ''Blind Test''. The Blind Test required the participants to predict the embrittlement of the irradiated specimen based only on dosimetry and metallurgical data from the SSC1 capsule. This exercise included both the prediction of damage fluence and the prediction of embrittlement based on the predicted fluence. A variety of prediction methodologies was used by the participants. No glaring biases or other deficiencies were found, but neither were any of the methods clearly superior to the others. Closer analysis shows a rather complex and poorly understood relation between fluence and material damage. Many prediction formulas can give an adequate approximation, but further improvement of the prediction methodology is unlikely at this time given the many unknown factors. Instead, attention should be focused on determining realistic uncertainties for the predicted material changes. The Blind Test comparisons provide some clues for the size of these uncertainties. In particular, higher uncertainties must be assigned to materials whose chemical composition lies outside the data set for which the prediction formula was obtained. 16 references, 14 figures, 5 tables.

  20. Sustained live poultry market surveillance contributes to early warnings for human infection with avian influenza viruses

    PubMed Central

    Fang, Shisong; Bai, Tian; Yang, Lei; Wang, Xin; Peng, Bo; Liu, Hui; Geng, Yijie; Zhang, Renli; Ma, Hanwu; Zhu, Wenfei; Wang, Dayan; Cheng, Jinquan; Shu, Yuelong

    2016-01-01

    Sporadic human infections with the highly pathogenic avian influenza (HPAI) A (H5N6) virus have been reported in different provinces in China since April 2014. From June 2015 to January 2016, routine live poultry market (LPM) surveillance was conducted in Shenzhen, Guangdong Province. H5N6 viruses were not detected until November 2015. The H5N6 virus-positive rate increased markedly beginning in December 2015, and viruses were detected in LPMs in all districts of the city. Coincidently, two human cases with histories of poultry exposure developed symptoms and were diagnosed as H5N6-positive in Shenzhen during late December 2015 and early January 2016. Similar viruses were identified in environmental samples collected in the LPMs and the patients. In contrast to previously reported H5N6 viruses, viruses with six internal genes derived from the H9N2 or H7N9 viruses were detected in the present study. The increased H5N6 virus-positive rate in the LPMs and the subsequent human infections demonstrated that sustained LPM surveillance for avian influenza viruses provides an early warning for human infections. Interventions, such as LPM closures, should be immediately implemented to reduce the risk of human infection with the H5N6 virus when the virus is widely detected during LPM surveillance. PMID:27485495

  1. Sustained live poultry market surveillance contributes to early warnings for human infection with avian influenza viruses.

    PubMed

    Fang, Shisong; Bai, Tian; Yang, Lei; Wang, Xin; Peng, Bo; Liu, Hui; Geng, Yijie; Zhang, Renli; Ma, Hanwu; Zhu, Wenfei; Wang, Dayan; Cheng, Jinquan; Shu, Yuelong

    2016-08-03

    Sporadic human infections with the highly pathogenic avian influenza (HPAI) A (H5N6) virus have been reported in different provinces in China since April 2014. From June 2015 to January 2016, routine live poultry market (LPM) surveillance was conducted in Shenzhen, Guangdong Province. H5N6 viruses were not detected until November 2015. The H5N6 virus-positive rate increased markedly beginning in December 2015, and viruses were detected in LPMs in all districts of the city. Coincidently, two human cases with histories of poultry exposure developed symptoms and were diagnosed as H5N6-positive in Shenzhen during late December 2015 and early January 2016. Similar viruses were identified in environmental samples collected in the LPMs and the patients. In contrast to previously reported H5N6 viruses, viruses with six internal genes derived from the H9N2 or H7N9 viruses were detected in the present study. The increased H5N6 virus-positive rate in the LPMs and the subsequent human infections demonstrated that sustained LPM surveillance for avian influenza viruses provides an early warning for human infections. Interventions, such as LPM closures, should be immediately implemented to reduce the risk of human infection with the H5N6 virus when the virus is widely detected during LPM surveillance.

  2. 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.

  3. [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.

  4. 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.

  5. Surveillance of tobacco industry retail marketing activities of reduced harm products.

    PubMed

    Slater, Sandy; Giovino, Gary; Chaloupka, Frank

    2008-01-01

    With the introduction of potential reduced exposure products (PREPs) and the interest in studying tobacco harm reduction, sound research and surveillance are needed to examine and understand the distribution and availability of PREPs in communities, as well as the tobacco industry's marketing practices surrounding these products. We examined the availability and marketing of PREPs in a national sample of tobacco retail stores. We also compared the price of PREPs to those of premium brand cigarettes and examined the distribution of PREPs in comparison with premium brand cigarettes by store type, urbanization, region, and race/ethnicity. We found that PREPs are not widely available, are priced similarly to leading cigarette brands, and have few promotional offers. We also found some significant differences in the distribution of PREPs and cigarettes, as well as in the distribution of Ariva and Omni, by store type and community demographics. The fact that this study used data collected nationally emphasizes the importance of these findings and helps shed some light on the tobacco industry's PREP marketing strategies. This study's national sample provides a unique perspective that needs to be replicated if and when other PREPs are widely marketed.

  6. 78 FR 39020 - Market Test on Gift Cards

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-28

    ... Market Test on Gift Cards AGENCY: Postal Regulatory Commission. ACTION: Notice. SUMMARY: The Commission is noticing a recent Postal Service filing requesting a temporary extension of a market test on gift... temporarily extend its Gift Card market test under 39 U.S.C. 3641(d).\\1\\ The market test is set to expire June...

  7. Establishment, test and evaluation of a prototype volcano surveillance system

    NASA Technical Reports Server (NTRS)

    Ward, P. L.; Eaton, J. P.; Endo, E.; Harlow, D.; Marquez, D.; Allen, R.

    1973-01-01

    A volcano-surveillance system utilizing 23 multilevel earthquake counters and 6 biaxial borehole tiltmeters is being installed and tested on 15 volcanoes in 4 States and 4 foreign countries. The purpose of this system is to give early warning when apparently dormant volcanoes are becoming active. The data are relayed through the ERTS-Data Collection System to Menlo Park for analysis. Installation was completed in 1972 on the volcanoes St. Augustine and Iliamna in Alaska, Kilauea in Hawaii, Baker, Rainier and St. Helens in Washington, Lassen in California, and at a site near Reykjavik, Iceland. Installation continues and should be completed in April 1973 on the volcanoes Santiaguito, Fuego, Agua and Pacaya in Guatemala, Izalco in El Salvador and San Cristobal, Telica and Cerro Negro in Nicaragua.

  8. 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.

  9. Marketing genetic tests: empowerment or snake oil?

    PubMed

    Bowen, Deborah J; Battuello, Kathryn M; Raats, Monique

    2005-10-01

    Genetic tests are currently being offered to the general public with little oversight and regulation as to which tests are allowed to be sold clinically and little control over the marketing and promotion of sales and use. This article provides discussion and data to indicate that the general public holds high opinions of genetic testing and that current media outlets for public education on genetic testing are not adequate to increase accurate knowledge of genetics. The authors argue that more regulation is needed to control and correct this problem in the United States.

  10. The use of surveillance data and market research to promote physical activity.

    PubMed

    Fridinger, Fred; Macera, Carol; Cordell, H Ken

    2002-08-01

    Using various types of data sources for assessing and monitoring physical activity behaviors on a population level adds to our ability to explain the relationships between individuals and their surrounding social and physical environments. This article presents the findings from part of a panel presentation on available data sets at the 2001 Cooper Conference on Innovative Approaches to Understanding and Influencing Physical Activity. First, an overview of large national epidemiologic and surveillance data sets is offered, followed by a discussion on the use of market segmentation data to complement more traditional sources of data by adding new dimensions to our understanding of target groups and potential intervention strategies. The relative advantages and disadvantages of using each type of data are also given, as well as recommendations for further use.

  11. A post-marketing surveillance study of formoterol (Foradil): its use in general practice in England.

    PubMed

    Wilton, Lynda V; Shakir, Saad A

    2002-01-01

    At the time of marketing, experience of long-term use of prescription medicines in general clinical practice is limited. Postmarketing surveillance is particularly important at this time when medicines may be prescribed to large numbers of patients of all ages, for long-term use. Following marketing of formoterol (Foradil) in the UK in 1996 we undertook a postmarketing surveillance study of formoterol use in general practice. A non-interventional observational cohort study was conducted using the technique of prescription-event monitoring. Exposure data were obtained from prescription details; outcome data from questionnaires sent to general practitioners approximately 12 months after the first prescription was dispensed for individual patients. Incidence rates were calculated for reported events, reasons for stopping treatment and outcomes of pregnancy were determined. Data were collected for 5777 patients aged 3 to 96 years, 65% of whom continued treatment for >12 months. Formoterol was prescribed 'off label', to 258 children, (4.5%) of the cohort. The most commonly reported events excluding those related to respiratory disease, were headache, tremor, palpitation, cramp and nausea/vomiting. These events were also among the more common reasons for stopping treatment and reported as suspected adverse drug reactions. 33 patients took formoterol during pregnancy. The cause of death was established for 186 of the 190 deaths (3% of cohort). Formoterol appears to have been well tolerated by the majority of patients in this study. The most frequently reported adverse events were those known to be associated with beta(2)-agonists, although the frequency of nausea/ vomiting was greater than given in Summary of Product Characteristics.

  12. 76 FR 3679 - Market Test of Experimental Product: “Marketing Mail Made Easy”

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-20

    ... From the Federal Register Online via the Government Publishing Office POSTAL SERVICE Market Test of Experimental Product: ``Marketing Mail Made Easy'' AGENCY: Postal Service TM . ACTION: Notice... 39 U.S.C. 3641(c)(1) that it will begin a market test of its ``Marketing Mail Made Easy...

  13. Community monitoring for youth violence surveillance: testing a prediction model.

    PubMed

    Henry, David B; Dymnicki, Allison; Kane, Candice; Quintana, Elena; Cartland, Jenifer; Bromann, Kimberly; Bhatia, Shaun; Wisnieski, Elise

    2014-08-01

    Predictive epidemiology is an embryonic field that involves developing informative signatures for disorder and tracking them using surveillance methods. Through such efforts assistance can be provided to the planning and implementation of preventive interventions. Believing that certain minor crimes indicative of gang activity are informative signatures for the emergence of serious youth violence in communities, in this study we aim to predict outbreaks of violence in neighborhoods from pre-existing levels and changes in reports of minor offenses. We develop a prediction equation that uses publicly available neighborhood-level data on disorderly conduct, vandalism, and weapons violations to predict neighborhoods likely to have increases in serious violent crime. Data for this study were taken from the Chicago Police Department ClearMap reporting system, which provided data on index and non-index crimes for each of the 844 Chicago census tracts. Data were available in three month segments for a single year (fall 2009, winter, spring, and summer 2010). Predicted change in aggravated battery and overall violent crime correlated significantly with actual change. The model was evaluated by comparing alternative models using randomly selected training and test samples, producing favorable results with reference to overfitting, seasonal variation, and spatial autocorrelation. A prediction equation based on winter and spring levels of the predictors had area under the curve ranging from .65 to .71 for aggravated battery, and .58 to .69 for overall violent crime. We discuss future development of such a model and its potential usefulness in violence prevention and community policing.

  14. 2007 Nevada Test Site Annual Illness and Injury Surveillance Report

    SciTech Connect

    U.S. Department of Energy, Office of Health, Safety and Health, Office of Health and Safety, Office of Illness and Injury Prevention Programs

    2009-06-30

    The U.S. Department of Energy’s (DOE) commitment to assuring the health and safety of its workers includes the conduct of epidemiologic surveillance activities that provide an early warning system for health problems among workers. The Illness and Injury Surveillance Program monitors illnesses and health conditions that result in an absence of workdays, occupational injuries and illnesses, and disabilities and deaths among current workers.

  15. 2008 Nevada Test Site Annual Illness and Injury Surveillance Report

    SciTech Connect

    U.S. Department of Energy, Office of Health, Safety and Health, Office of Health and Safety, Office of Illness and Injury Prevention Programs

    2009-10-05

    The U.S. Department of Energy’s (DOE) commitment to assuring the health and safety of its workers includes the conduct of epidemiologic surveillance activities that provide an early warning system for health problems among workers. The Illness and Injury Surveillance Program monitors illnesses and health conditions that result in an absence of workdays, occupational injuries and illnesses, and disabilities and deaths among current workers.

  16. 2006 Nevada Test Site Annual Illness and Injury Surveillance Report

    SciTech Connect

    U.S. Department of Energy, Office of Health, Safety and Health, Office of Health and Safety, Office of Illness and Injury Prevention Programs

    2008-04-24

    The U.S. Department of Energy’s (DOE) commitment to assuring the health and safety of its workers includes the conduct of illness and injury surveillance activities that provide an early warning system to detect health problems among workers. The Illness and Injury Surveillance Program monitors illnesses and health conditions that result in an absence, occupational injuries and illnesses, and disabilities and deaths among current workers.

  17. [Surveillance of drinking water supply systems on markets and in vehicles].

    PubMed

    Rädel, U; Puchert, W; Suchenwirth, R

    2007-03-01

    The new German Drinking Water Ordinance (TrinkwV 2001) demands that the requirements of water intended for human consumption be met up to the intrinsic tap, at which the water is used. This also applies to water supply systems for food trade aboard non-stationary facilities and in vehicles for commercial purposes. In contrast to stationary units for drinking water supply, the nonstationary units relocate and the responsibility changes with each public health authority agent. Therefore, a coordinated action between the federal states is desirable and necessary. The experience of the public health departments presents many non-compliant parameters of microbiology in water supply systems on markets and in vehicles. The development of practical and consistent recommendations for the surveillance of non-stationary units is required to give consistent standards to the users. The article gives a review about legal foundations and technical rules in order to define the drinking water supply systems on markets and in vehicles in compliance with the German Drinking Water Ordinance. Examples of laboratory results from different monitoring episodes from three federal states are shown.

  18. Current and future surveillance testing: WH atmosphere, HE and cellular silicone

    SciTech Connect

    LeMay, J.D.

    1996-04-01

    Selected surveillance data on warhead atmospheres, high explosives, and cellular silicone stress cushions will be presented for LLNL Enduring Stockpile weapons. Possible interpretations of apparent aging trends will be offered. Thoughts on additional surveillance testing that could enhance or ability to identify age related changes will be discussed.

  19. 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

  20. [Assessment of intracutaneous test in longitudinal surveillance for lymphatic filariasis].

    PubMed

    Shi, F T; Ling, X M; Shi, H H; Huang, Q; Shi, Z J

    1989-01-01

    In order to evaluate the usefulness of intracutaneous test (IT) in longitudinal surveillance of filariasis, two administrative villages selected from Queshan County, Henan Province of China, endemic for Wuchereria bancrofti, were surveyed in 1982, 1983 and 1987 respectively, by IT with antigen FPT derived from Dirofilaria immitis. The result showed that the original level of IT to antigen FPT in the population was consistent with the data of either etiological or entomological investigation before chemotherapy. When the microfilaraemia rate and natural filarial infection rate of mosquitoes in a village were high, the positive rate and frequency of strong positivity (skin wheel diameter greater than or equal to 1.3 mm) for immediate hypersensitivity reaction would be high too; and the reverse was true. It is suggested that both criteria of IT mentioned above may be useful in assessing endemicity of lymphatic filariasis before mass chemotherapy. The speed of negative conversion of IT in both groups, the previously microfilaraemic patients and the microfilaraemic inhabitants positive to immediate hypersensitivity reaction before chemotherapy, were different, the former being significantly slower than that of the latter after mass and selective chemotherapy with diethylcarbamazine. All of the three criteria for immediate hypersensitivity, positive rate, frequency of strong positivity and positive conversion rate, decreased gradually after a mass and selective DEC treatment. Until 1987, the 5th year after the chemotherapy, the average positive rate in the two villages dropped to 20.0% from 55.4% in 1982, the frequency of strong positivity to 2.8% from 23.8% in 1982, and the positive conversion rate to 9.7% (1984-1987) form 19.2% (1982-1983).(ABSTRACT TRUNCATED AT 250 WORDS)

  1. 75 FR 70753 - Market Test Involving Greeting Cards

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-18

    ... Market Test Involving Greeting Cards AGENCY: Postal Regulatory Commission. ACTION: Notice. SUMMARY: The Commission is noticing a recently-filed Postal Service proposal to conduct a market test involving greeting cards. A key feature of the market test is an alternative arrangement for payment of postage. Under this...

  2. 78 FR 51678 - Market Tests of Experimental Postal Products

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-21

    ... 39 CFR Parts 3001 and 3035 Market Tests of Experimental Postal Products AGENCY: Postal Regulatory... Service filings concerning market tests of experimental products. The proposed rules address the contents of market test filings, describe how the filings will be reviewed, and discuss related matters. The...

  3. 76 FR 3180 - Market Test of Gift Cards

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-19

    ... Market Test of Gift Cards AGENCY: Postal Regulatory Commission. ACTION: Notice. SUMMARY: The Commission is noticing a recently-field Postal Service proposal to conduct a 2-year market test involving the..., pursuant to 39 U.S.C. 3641, announcing its intent to initiate a market test beginning on or about May 1...

  4. 40 CFR 720.38 - Exemptions for test marketing.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 31 2011-07-01 2011-07-01 false Exemptions for test marketing. 720.38... CONTROL ACT PREMANUFACTURE NOTIFICATION Applicability § 720.38 Exemptions for test marketing. (a) Any person may apply for an exemption to manufacture or import a new chemical substance for test marketing...

  5. 40 CFR 720.38 - Exemptions for test marketing.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Exemptions for test marketing. 720.38... CONTROL ACT PREMANUFACTURE NOTIFICATION Applicability § 720.38 Exemptions for test marketing. (a) Any person may apply for an exemption to manufacture or import a new chemical substance for test marketing...

  6. Fundamentals of Marketing Core Curriculum. Test Items and Assessment Techniques.

    ERIC Educational Resources Information Center

    Smith, Clifton L.; And Others

    This document contains multiple choice test items and assessment techniques for Missouri's fundamentals of marketing core curriculum. The core curriculum is divided into these nine occupational duties: (1) communications in marketing; (2) economics and marketing; (3) employment and advancement; (4) human relations in marketing; (5) marketing…

  7. 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.

  8. 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

  9. 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.

  10. 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.

  11. [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.

  12. 78 FR 41128 - Market Test of International Merchandise Return Service

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-09

    ... Market Test of International Merchandise Return Service AGENCY: Postal Regulatory Commission. ACTION: Notice SUMMARY: The Commission is noticing a recently-filed Postal Service proposal to conduct a market... Service filed a notice, pursuant to 39 U.S.C. 3641, announcing its intent to conduct a market test of a...

  13. [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.

  14. [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.

  15. 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.

  16. 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.

  17. 40 CFR 720.38 - Exemptions for test marketing.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 32 2012-07-01 2012-07-01 false Exemptions for test marketing. 720.38... CONTROL ACT PREMANUFACTURE NOTIFICATION Applicability § 720.38 Exemptions for test marketing. (a) Any person may apply for an exemption to manufacture or import a new chemical substance for test...

  18. 40 CFR 720.38 - Exemptions for test marketing.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 31 2014-07-01 2014-07-01 false Exemptions for test marketing. 720.38... CONTROL ACT PREMANUFACTURE NOTIFICATION Applicability § 720.38 Exemptions for test marketing. (a) Any person may apply for an exemption to manufacture or import a new chemical substance for test...

  19. 40 CFR 720.38 - Exemptions for test marketing.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 32 2013-07-01 2013-07-01 false Exemptions for test marketing. 720.38... CONTROL ACT PREMANUFACTURE NOTIFICATION Applicability § 720.38 Exemptions for test marketing. (a) Any person may apply for an exemption to manufacture or import a new chemical substance for test...

  20. Effect of Culture-Independent Diagnostic Tests on Future Emerging Infections Program Surveillance

    PubMed Central

    Besser, John; Iwamoto, Martha; Lessa, Fernanda C.; Cronquist, Alicia; Skoff, Tami H.; Chaves, Sandra; Boxrud, Dave; Pinner, Robert W.; Harrison, Lee H.

    2015-01-01

    The Centers for Disease Control and Prevention Emerging Infections Program (EIP) network conducts population-based surveillance for pathogens of public health importance. Central to obtaining estimates of disease burden and tracking microbiological characteristics of these infections is accurate laboratory detection of pathogens. The use of culture-independent diagnostic tests (CIDTs) in clinical settings presents both opportunities and challenges to EIP surveillance. Because CIDTs offer better sensitivity than culture and are relatively easy to perform, their use could potentially improve estimates of disease burden. However, changes in clinical testing practices, use of tests with different sensitivities and specificities, and changes to case definitions make it challenging to monitor trends. Isolates are still needed for performing strain typing, antimicrobial resistance testing, and identifying other molecular characteristics of organisms. In this article, we outline current and future EIP activities to address issues associated with adoption of CIDTs, which may apply to other public health surveillance. PMID:26291736

  1. Effect of Culture-Independent Diagnostic Tests on Future Emerging Infections Program Surveillance.

    PubMed

    Langley, Gayle; Besser, John; Iwamoto, Martha; Lessa, Fernanda C; Cronquist, Alicia; Skoff, Tami H; Chaves, Sandra; Boxrud, Dave; Pinner, Robert W; Harrison, Lee H

    2015-09-01

    The Centers for Disease Control and Prevention Emerging Infections Program (EIP) network conducts population-based surveillance for pathogens of public health importance. Central to obtaining estimates of disease burden and tracking microbiological characteristics of these infections is accurate laboratory detection of pathogens. The use of culture-independent diagnostic tests (CIDTs) in clinical settings presents both opportunities and challenges to EIP surveillance. Because CIDTs offer better sensitivity than culture and are relatively easy to perform, their use could potentially improve estimates of disease burden. However, changes in clinical testing practices, use of tests with different sensitivities and specificities, and changes to case definitions make it challenging to monitor trends. Isolates are still needed for performing strain typing, antimicrobial resistance testing, and identifying other molecular characteristics of organisms. In this article, we outline current and future EIP activities to address issues associated with adoption of CIDTs, which may apply to other public health surveillance.

  2. 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.

  3. 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.

  4. 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.

  5. Postmarketing surveillance study of a non-chlorofluorocarbon inhaler according to the safety assessment of marketed medicines guidelines

    PubMed Central

    Ayres, J G; Frost, C D; Holmes, W F; Williams, D R R; Ward, S M

    1998-01-01

    Objective To evaluate the safety of a non-chlorofluorocarbon metered dose salbutamol inhaler. Design This was a postmarketing surveillance study, conducted under formal guidelines for company sponsored safety assessment of marketed medicines (SAMM). A non-randomised, non-interventional, observational design compared patients prescribed metered doses of salbutamol delivered by inhalers using either hydrofluoroalkane or chlorofluorocarbon as the propellant. Follow up was three months. Setting 646 general practices throughout the United Kingdom. Subjects 6614 patients with obstructive airways disease (1667 patient years of exposure). Main outcome measures Proportions of patients who were: admitted to hospital for respiratory diseases, reported adverse side effects, or withdrew because of adverse affects. Results There were no significant differences between the hydrofluoroalkane (HFA 134a) and chlorofluorocarbon inhaler groups in relation to the proportions of patients admitted to hospital for respiratory diseases (odds ratio 0.75; 95% confidence interval 0.51 to 1.08) or the proportions who reported adverse events (1.01; 0.88 to 1.17). However, more patients using the hydrofluoroalkane inhaler than the chlorofluorocarbon inhaler withdrew because of adverse events (3.8% and 0.9% respectively). Conclusion The hydrofluoroalkane inhaler was as safe as the chlorofluorocarbon inhaler when judged by hospital admissions and adverse affects. The study design successfully fulfilled the recommendations of the guidelines. Differences between postmarketing surveillance studies and randomised clinical trials in assessing safety were identified. These may lead to difficulties in the design of postmarketing surveillance studies. Key messagesCredibility of postmarketing surveillance studies is expected to increase after the introduction of guidelines covering their conduct The study design successfully fulfilled the requirements of these guidelines in terms of the number, rate, and

  6. Changes in European legislation make it timely to introduce a transparent market surveillance system for cosmetics.

    PubMed

    Lodén, Marie; Ungerth, Louise; Serup, Jørgen

    2007-01-01

    Marketing of cosmetics often makes strong claims linked to active ingredients. This is especially so for anti-ageing products, where the presentation and content of "active" ingredients may create new difficulties in their classification as cosmetics or medicinal products. A recent change in European legislation classifies a product as medicinal by virtue of its "function", in addition to the previous definition of "presentation" (i.e. marketing linked to diseases). Thus, formulations that also restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action should henceforth be covered by the Medicinal Products Directive. A cosmetic product must be suitable for its purpose and should not lead to adverse reactions that are disproportional in relation to its intended effect. However, the forthcoming ban on animal testing of cosmetic ingredients and the new European regulation, REACH (Registration, Evaluation and Authorisation of Chemicals), which aims to ensure a high level of chemical safety to protect human health and the environment, will probably have limited impact on the safety assessment of cosmetics. In order to enable consumers to make informed purchasing decisions, greater transparency in the process of assessing the performance of cosmetics is needed. Introduction of a more transparent system, enabling consumers and professionals to examine the scientific evidence for the claimed effect and the safety assessment of cosmetics, is therefore timely. Lack of transparency increases the risk of consumers wasting money on cosmetics that do not deliver the desired effects. This may jeopardize public trust in the cosmetic industry.

  7. Use of CA-125 Tests and CT Scans for Surveillance in Ovarian Cancer

    PubMed Central

    Esselen, Katharine M.; Cronin, Angel M.; Bixel, Kristin; Bookman, Michael A.; Burger, Robert A.; Cohn, David E.; Cristea, Mihaela; Griggs, Jennifer J.; Levenback, Charles F.; Mantia-Smaldone, Gina; Meyer, Larissa A.; Matulonis, Ursula A.; Niland, Joyce C.; Sun, Charlotte; O’Malley, David M.; Wright, Alexi A.

    2016-01-01

    Importance A 2009 randomized clinical trial (RCT) demonstrated that using CA-125 tests for routine surveillance in ovarian cancer increases chemotherapy use and decreases patients’ quality of life without improving survival, compared with clinical observation. The Society of Gynecologic Oncology guidelines categorize CA-125 testing as “optional” and discourage the use of radiographic imaging for routine surveillance. To date, few studies have examined their use in clinical practice. Objective To examine the use of CA-125 tests and CT scans in clinical practice before and after the 2009 RCT and estimate the economic impact of surveillance testing. Design Prospective cohort of women diagnosed with ovarian cancer between 2004-2011 and followed through 2012. Setting Six National Cancer Institute-Designated Cancer Centers. Participants 1,241 women with ovarian cancer in clinical remission after completion of primary cytoreductive surgery and chemotherapy. Main Outcome Measures Use of CA-125 tests and CT scans before and after 2009 (n=1,241). Secondary outcomes included: the time from CA-125 doubling to retreatment among women who experienced a rise in CA-125 (n=511) before and after 2009, and the costs associated with surveillance testing using 2016 Medicare reimbursement rates. Results Use of CA-125 testing and CT scans was very similar over the study period. During 12 months of surveillance, the cumulative incidence of 3 or more CA-125 tests was 86% in 2004-2009 versus 91% in 2010-2012 (P=.95), and the cumulative incidence of more than 1 CT scan was 81% (2004-2009) versus 78% (2010-2012) (P=.50). Among women who experienced a CA-125 doubling (n=511), there was no significant difference in the time to retreatment with chemotherapy before and after 2009 (median: 2.8 months vs. 3.5 months, P=.40). Over a 12-month period, there were a mean of 4.6 CA-125 tests and 1.7 CT scans per patient, resulting in a United States population surveillance cost estimate of $1

  8. 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

  9. 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

  10. 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.

  11. Roadside sobriety tests and attitudes toward a regulated cannabis market

    PubMed Central

    Looby, Alison; Earleywine, Mitch; Gieringer, Dale

    2007-01-01

    Background Many argue that prohibition creates more troubles than alternative policies, but fewer than half of American voters support a taxed and regulated market for cannabis. Some oppose a regulated market because of concerns about driving after smoking cannabis. Although a roadside sobriety test for impairment exists, few voters know about it. The widespread use of a roadside sobriety test that could detect recent cannabis use might lead some voters who currently oppose a regulated market to support it. In contrast, a question that primes respondents about the potential for driving after cannabis use might lead respondents to be less likely to support a regulated market. Methods Phone interviews with a national sample of 1002 registered voters asked about support for a regulated cannabis market and support for such a market if a reliable roadside sobriety test were widely available. Results In this sample of registered voters, 36% supported a regulated cannabis market. Exploratory chi-square tests revealed significantly higher support among men and Caucasians but no link to age or education. These demographic variables covaried significantly. Logistic regression revealed that gender, ethnicity, and political party were significant when all predictors were included. Support increased significantly with a reliable roadside sobriety test to 44%, but some respondents who had agreed to the regulated market no longer agreed when the sobriety test was mentioned. Logistic regression revealed that ethnicity and political affiliation were again significant predictors of support with a reliable sobriety test, but gender was no longer significant. None of these demographic variables could identify who would change their votes in response to the reliable roadside test. Conclusion Increased awareness and use of roadside sobriety tests that detect recent cannabis use could increase support for a regulated cannabis market. Identifying concerns of voters who are not Caucasian

  12. Beyond Testing: Empirical Models of Insurance Markets

    PubMed Central

    Einav, Liran; Finkelstein, Amy; Levin, Jonathan

    2011-01-01

    We describe recent advances in the empirical analysis of insurance markets. This new research proposes ways to estimate individual demand for insurance and the relationship between prices and insurer costs in the presence of adverse and advantageous selection. We discuss how these models permit the measurement of welfare distortions arising from asymmetric information and the welfare consequences of potential government policy responses. We also discuss some challenges in modeling imperfect competition between insurers and outline a series of open research questions. PMID:21572939

  13. Environmental surveillance report for the Nevada Test Site (January 1980-December 1980)

    SciTech Connect

    Scoggins, W.A.

    1981-01-01

    Results are presented for the environmental surveillance program at the Nevada Test Site as conducted by the Department of Energy (DOE) onsite radiological safety contractor from January 1980 through December 1980. The results and evaluations of measurements of radioactivity in air and water, and of direct gamma radiation exposure rates are presented. Relevancy to DOE concentration guides (CG'S) is established.

  14. Environmental surveillance report for the Nevada Test Site, January-December 1979

    SciTech Connect

    Lantz, M.W.

    1980-06-01

    The environmental surveillance program at the Nevada Test Site as conducted by the Department of Energy (DOE) onsite radiological safety contractor is documented from January 1979 through December 1979. The results and evaluations of measurements of radioactivity in air and water, and of direct gamma radiation exposure rates are presented. Relevancy to DOE concentration guides (CG'S) is established.

  15. Integrated Multi-Sensor System for Enhanced Space Surveillance - Design, Engineering, Integration and Tests

    NASA Astrophysics Data System (ADS)

    Liu, S.; Markov, V.; Ewart, R.; Craig, D.

    Space surveillance requires capabilities for detection, tracking, imaging and characterization of specific objects in space environment. In general, most current space surveillance systems are single-sensor based and are not capable of generating the desired tracking accuracy, and providing required object characterization. A suite of various types of the sensors that are spatially or temporarily separated may thus be used collectively to synthesize a composite, improved surveillance picture through fusion and post processing of retrieved data. However, this approach will not yield the highest possible data accuracy due to the errors introduced in correlation of location, orientation and detection time from different sensors. Furthermore, it may not provide timely surveillance data to the user and hence may degrade the utility of these data. In this paper, we present the architecture, operational concept and preliminary design of an advanced integrated multi-sensor system (AIMS) for enhanced space surveillance capability to alleviate these shortfalls. AIMS employs an active laser tracking and multiple spectral domain (visible and multi-band IR) sensing to provide high-resolution tracking, three-dimensional imaging and reliable characterization of space objects with down range resolution of 1 cm and velocity measurement accuracy of 1-10 cm/sec in near real-time. The engineering and integration of a scale-down prototype of AIMS together with results of initial field tests are reported in this paper. Issues, lessons learned, future development plan and potential application of AIMS to space missions will be discussed.

  16. Testing effects of Glatiramer Acetate and Fingolimod in an infectious model of CNS immune surveillance

    PubMed Central

    Castro-Rojas, Cyd; Deason, Krystin; Hussain, Rehana Z.; Hayardeny, Liat; Cravens, Petra C.; Yarovinsky, Felix; Eagar, Todd N.; Arellano, Benjamine; Stüve, Olaf

    2015-01-01

    Immune surveillance of the CNS is critical for preventing infections, however there is no accepted experimental model to assess the risk of infection when utilizing disease-modifying agents. We tested two approved agents for patients with multiple sclerosis (MS), glatiramer acetate and fingolimod, in an experimental model of CNS immune surveillance. C57BL/6 mice were infected with the ME49 strain of the neuroinvasive parasite Toxoplasma gondii (T. gondii) and then treated with GA and fingolimod. Neither treatment affected host survival, however differences were observed in parasite load and in leukocyte numbers in the brains of infected animals. Here we demonstrate that this model could be a useful tool for analyzing immune surveillance. PMID:25227585

  17. Vision Tests For Medical Surveillance Or To Insure Job Fitness

    NASA Astrophysics Data System (ADS)

    Wolbarsht, M. L.; Landers, M. B.

    1986-05-01

    The rationale for designing screening type eye examinations to document visual capabilities for specific jobs or changes in visual function following exposure to specific ocular hazards is discussed. Possible applications to clinical situations are also discussed. Specific tests meeting requirements of definite end point quantification, ease of administration, and reproducibility are given for contrast (glare) sensitivity, distortions in macular imaging (Amsler grid), and color vision. The selection is aetailed for tne individual test combinations of various populations such as automobile uriver license applicants, visual display operators, and persons exposed to lasers, including military as well as non-military installers and repairers of optical fibers for communications.

  18. Viral load: Roche applies for marketing approval for ultrasensitive test.

    PubMed

    1998-08-07

    Roche Molecular Systems has applied for FDA permission to market a more sensitive viral load test. The Amplicor HIV-1 Monitor UltraSensitive Method tests viral load as low as 50 copies; current tests are only accurate to 400 copies. There is a widespread consensus among physicians that testing below 400 copies would be a valuable treatment tool.

  19. Comparative value of noninvasive testing for diagnosis and surveillance of deep vein thrombosis

    SciTech Connect

    Comerota, A.J.; Katz, M.L.; Grossi, R.J.; White, J.V.; Czeredarczuk, M.; Bowman, G.; DeSai, S.; Vujic, I.

    1988-01-01

    This is a prospective analysis of 351 patients in two distinct groups undergoing ascending phlebography, impedance plethysmography (IPG), and/or phleborheography (PRG) within the same 24-hour period. One hundred twenty patients also had a /sup 125/I-fibrinogen uptake test (RFUT). The two patient groups consisted of the following: those patients evaluated because of suspicion of deep vein thrombosis (DVT) (diagnostic) and those patients at high risk for postoperative DVT (total joint replacement) who had routine noninvasive testing and ascending phlebography (surveillance). The overall sensitivities for IPG and PRG were significantly better in the diagnosis group (71% (69 of 97 patients) and 78% (82 of 105), respectively) compared with the surveillance group (20% (14 of 71) and 27% (17 of 63), respectively) (p less than 0.0001). The sensitivities for IPG and PRG detecting proximal (A/K) thrombi was 83% (68 of 82 patients) and 92% (79 of 86) in the diagnosis group compared with 32% (11 of 34) and 33% (9 of 27) in the surveillance group (p less than 0.0001). Although there was no difference in overall incidence of DVT between the diagnosis group (56%, 118 of 212 patients) and the surveillance group (55%, 76 of 139), the results can be explained by the difference in A/K thrombi (84% (99 of 118) and 47% (36 of 76)) (p less than 0.001) and occlusive A/K thrombi (84% (58 of 69) and 23% (7 of 31)) (p less than 0.0001), respectively. Of the patients with A/K thrombi, 97% (67 of 69) in the diagnosis group had hemodynamically detectable thrombi compared with only 48% (12 of 25) in the surveillance group (p less than 0.001). Combining the RFUT with the noninvasive studies for surveillance significantly improved the sensitivity for both A/K and distal thrombi.

  20. Point of Sale Scanner Data for Rapid Surveillance of the E-cigarette Market.

    PubMed

    Day, Hannah R; Ambrose, Bridget K; Schroeder, Megan J; Corey, Catherine G

    2017-01-01

    Describe e-cigarette sales trends and market share from U.S. convenience stores and mass market retailers. We used Nielsen Scantrack to calculate U.S. e-cigarette sales market share from convenience and mass market channels during the 4-week period ending 1/19/13 through the period ending 12/19/15. Internet searches were used to supplement Nielsen product information. From 2013 to 2015, rechargeable e-cigarette brands VUSE and MarkTen experienced the largest growth in Nielsen channels. E-liquid and tank type brands Vapin Plus and Haus experienced growth although their Nielsen market share is small compared to other brands. Sales of brands with high labeled nicotine content (according to packaging or website) increased. Fruit-flavored sales increased rapidly in Nielsen, yet still represent a minority of market share in these channels. Market-leading e-cigarette brands changed substantially in Nielsen channels from 2013 to 2015. Brand leaders in these channels are now owned by tobacco companies. Changes in labelled nicotine content and fruit-flavored products and product types suggest that as e-cigarette use increases, convenience store and mass market channels are offering new products to meet consumer preferences; however, Nielsen channels do not represent the entire e-cigarette marketplace.

  1. Quali-quantitative analysis of best selling drugs from pharmacy, street market and traditional herbal medicine: a pilot study of market surveillance in Senegal.

    PubMed

    Pichini, Simona; Rotolo, Maria Concetta; Bellotti, Pasquale; Minutillo, Adele; Mastrobattista, Luisa; Pacifici, Roberta

    2015-02-01

    A pilot study of market surveillance in Senegal has been performed analyzing best selling drugs from an official pharmacy and a street market in two principal cities of Senegal and some traditional preparations from herbal medicine from the same market. A simple and rapid gas chromatography method with mass spectrometry detection has been applied after a liquid-liquid extraction of pharmaceutical products and traditional preparations at acidic, neutral and basic pH with chloroform-isopropanol (9:1, v/v). The assay was validated in the range from 10mg to 250 mg/g powder preparations with good determination coefficients (r(2)≥ 0.99) for the calibration curves. At three concentrations spanning the linear dynamic ranges of the calibration curves, mean recoveries of substances under investigation were always higher than 90% and intra-assay and inter-assay precision and accuracy were always better than 15%. The four best selling drugs purchased from a Dakar local pharmacy exactly contained the amount of active principles reported in the respective labels while the best selling drugs freely purchased from Kaolack market contained an amount of active ingredients lower than that declared on the label. No pharmacological active compound, but salicylic acid was found in one of the traditional herbal preparations. This pilot study showed that whereas official drugs sold in pharmacies at prices accessible for a very few portion of the population contained the amount of active principles as reported in the labels, those from street market bought by the majority of population contained an amount of active ingredients lower than that declared on the label and finally traditional herbal preparations seldom contain pharmacological active principles.

  2. Automated Acquisition of Copperhead Stockpile Surveillance Test Data

    DTIC Science & Technology

    1990-12-01

    type pulse used to simulate the laser light seen by the round during operation. Ar H.P. 8112A pulse generator and H.P. 8496 attenuator are used to...collection window arid idle time respectively. Memory pointer settings follow on line 920 along with tile specification of scanner channel...in the test’s driver routine and functions as a pointer to a particular course of action. Such actions include the setting of attenuations, pulse

  3. Test Marketing Exemption (TME) for New Chemical Review under TSCA

    EPA Pesticide Factsheets

    Under section 5 of TSCA, EPA established an exemption for certain chemicals that are manufactured (including imported) for test marketing. You can learn more here about the requirements of this exemption, along with the review and submission process.

  4. Manage marketing by the customer equity test.

    PubMed

    Blattberg, R C; Deighton, J

    1996-01-01

    Managers have recently begun to think of good marketing as good conversation, as a process of drawing customers into progressively more satisfying relationships with a company. And just as the art of conversation follows two steps--first striking up a conversation with a likely partner and then maintaining the flow--so the new marketing naturally divides itself into the work of customer acquisition and the work of customer retention. But how can managers determine the optimal balance between spending on acquisition and spending on retention? Robert Blattberg and John Deighton use decision calculus to help managers answer that question. That is, they ask managers to approach the large, complex problem through several smaller, more manageable questions on the same topic. Then they use a formal model to turn those smaller judgments into an answer to the larger question. The ultimate goal, the authors say, is to grow the company's customer equity the sum of all the conversations-to its fullest potential. Recognizing that managers must constantly reassess the spending points determined by the decision-calculus model, the authors also provide a series of guidelines and suggestions to help frame the issues that affect acquisition, retention, and customer equity. When managers strive to grow customer equity rather than a brand's sales or profits, they put a primary indicator of the health of the business at the fore front of their strategic thinking: the quality of customer relationships.

  5. Test and Evaluation of Medical Data Surveillance System at Navy and Marine Corps MTFs

    DTIC Science & Technology

    2007-11-02

    Marines What is your present position title? GMO (general medical officer) PMO (preventive medicine officer) EHO (environmental health officer) IDC...NAVAL HEALTH RESEARCH CENTER TEST AND EVALUATION OF MEDICAL DATA SURVEILLANCE SYSTEM AT NAVY AND MARINE CORPS MTFs Test & Evaluation Group T. Melcer...B. Bohannan R. Burr T. Leap C. Reed B. Jeschonek Report No. 03-14 Approved for public release; distribution unlimited. NAVAL HEALTH RESEARCH CENTER

  6. Enhancement of Influenza Surveillance With Aggregate Rapid Influenza Test Results: New Mexico, 2003–2007

    PubMed Central

    Mueller, Mark; Smelser, Chad; Albanese, Bernadette; Sewell, C. Mack

    2009-01-01

    Objectives. We sought to determine whether monitoring rapid influenza laboratory tests improved the influenza-like illness surveillance already in place in New Mexico. Methods. For the past 3 influenza seasons, the New Mexico Department of Health examined influenza-like illness visits and positive rapid influenza test results. Results. The proportion of positive rapid influenza test results started to rise earlier than did the percentage of clinical visits because of influenza-like illness in each of the past 3 influenza seasons: 5 weeks earlier during the 2004–2005 season; 3 weeks earlier in 2005–2006; and 2 weeks earlier in 2006–2007. In addition, rapid influenza tests showed a spike in influenza B activity late in the 2005–2006 season that influenza-like illness syndrome surveillance did not. Conclusions. Laboratory-based rapid influenza test surveillance required relatively few resources to implement and offered a sensitive mechanism to detect the onset of influenza activity while allowing for the distinction of influenza types. PMID:18923127

  7. Routine feedback of test results to participants in clinic- and survey-based surveillance of HIV

    PubMed Central

    Johnson, Cheryl; Garcia Calleja, Jesus Maria; Sabin, Keith; Obermeyer, Carla; Taegtmeyer, Miriam; Zaba, Basia; El-Hayek, Carol; Singh, Jerome Amir

    2015-01-01

    Abstract Surveillance for human immunodeficiency virus (HIV) in low- and middle-income countries started in the 1980s. However, the questions of whether the results of HIV tests should be given to participants, and if so how, has still not been resolved. In the absence of effective treatment, it was considered acceptable to withhold results from HIV-positive participants. However, when antiretroviral treatment is available, some argue for beneficence – that it is the researcher’s duty to return the test results to all those who provide samples for surveillance. The corollary is that only participants who wish to receive their test results would be eligible to participate in surveys. Others argue for autonomy – that to obtain a more representative result for the general population, surveys should not exclude participants who do not wish to receive their test results. This round table discussion takes a closer look at those two arguments. We believe that the global community should work towards routine feedback of HIV surveillance while ensuring that participants receive and understand their test results. PMID:26229207

  8. Routine feedback of test results to participants in clinic- and survey-based surveillance of HIV.

    PubMed

    Baggaley, Rachel; Johnson, Cheryl; Garcia Calleja, Jesus Maria; Sabin, Keith; Obermeyer, Carla; Taegtmeyer, Miriam; Zaba, Basia; El-Hayek, Carol; Singh, Jerome Amir

    2015-05-01

    Surveillance for human immunodeficiency virus (HIV) in low- and middle-income countries started in the 1980s. However, the questions of whether the results of HIV tests should be given to participants, and if so how, has still not been resolved. In the absence of effective treatment, it was considered acceptable to withhold results from HIV-positive participants. However, when antiretroviral treatment is available, some argue for beneficence - that it is the researcher's duty to return the test results to all those who provide samples for surveillance. The corollary is that only participants who wish to receive their test results would be eligible to participate in surveys. Others argue for autonomy - that to obtain a more representative result for the general population, surveys should not exclude participants who do not wish to receive their test results. This round table discussion takes a closer look at those two arguments. We believe that the global community should work towards routine feedback of HIV surveillance while ensuring that participants receive and understand their test results.

  9. 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 surveillance population). These results demonstrated that, in routine medical practice, FSME-IMMUN "NEW" vaccine at a dose of 1.2 microg antigen/0.25 ml is safe for the first vaccination in children.

  10. 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.

  11. Testing neoclassical competitive market theory in the field.

    PubMed

    List, John A

    2002-11-26

    This study presents results from a pilot field experiment that tests predictions of competitive market theory. A major advantage of this particular field experimental design is that my laboratory is the marketplace: subjects are engaged in buying, selling, and trading activities whether I run an exchange experiment or am a passive observer. In this sense, I am gathering data in a natural environment while still maintaining the necessary control to execute a clean comparison between treatments. The main results of the study fall into two categories. First, the competitive model predicts reasonably well in some market treatments: the expected price and quantity levels are approximated in many market rounds. Second, the data suggest that market composition is important: buyer and seller experience levels impact not only the distribution of rents but also the overall level of rents captured. An unexpected result in this regard is that average market efficiency is lowest in markets that match experienced buyers and experienced sellers and highest when experienced buyers engage in bargaining with inexperienced sellers. Together, these results suggest that both market experience and market composition play an important role in the equilibrium discovery process.

  12. Use of CA-125 Tests and Computed Tomographic Scans for Surveillance in Ovarian Cancer.

    PubMed

    Esselen, Katharine M; Cronin, Angel M; Bixel, Kristin; Bookman, Michael A; Burger, Robert A; Cohn, David E; Cristea, Mihaela; Griggs, Jennifer J; Levenback, Charles F; Mantia-Smaldone, Gina; Meyer, Larissa A; Matulonis, Ursula A; Niland, Joyce C; Sun, Charlotte; O'Malley, David M; Wright, Alexi A

    2016-11-01

    A 2009 randomized clinical trial demonstrated that using cancer antigen 125 (CA-125) tests for routine surveillance in ovarian cancer increases the use of chemotherapy and decreases patients' quality of life without improving survival, compared with clinical observation. The Society of Gynecologic Oncology guidelines categorize CA-125 testing as optional and discourage the use of radiographic imaging for routine surveillance. To date, few studies have examined the use of CA-125 tests in clinical practice. To examine the use of CA-125 tests and computed tomographic (CT) scans in clinical practice before and after the 2009 randomized clinical trial and to estimate the economic effect of surveillance testing. A prospective cohort of 1241 women with ovarian cancer in clinical remission after completion of primary cytoreductive surgery and chemotherapy at 6 National Cancer Institute-designated cancer centers between January 1, 2004, and December 31, 2011, was followed up through December 31, 2012, to study the use of CA-125 tests and CT scans before and after 2009. Data analysis was conducted from April 9, 2014, to March 28, 2016. The use of CA-125 tests and CT scans before and after 2009. Secondary outcomes included the time from CA-125 markers doubling to retreatment among women who experienced a rise in CA-125 markers before and after 2009, and the costs associated with surveillance testing using 2015 Medicare reimbursement rates. Among 1241 women (mean [SD] age 59 [12] years; 1112 white [89.6%]), the use of CA-125 testing and CT scans was similar during the study period. During 12 months of surveillance, the cumulative incidence of patients undergoing 3 or more CA-125 tests was 86% in 2004-2009 vs 91% in 2010-2012 (P = .95), and the cumulative incidence of patients undergoing more than 1 CT scan was 81% in 2004-2009 vs 78% in 2010-2012 (P = .50). Among women whose CA-125 markers doubled (n = 511), there was no significant difference in the time to

  13. 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.

  14. Detection of Avian Influenza A(H7N9) Virus from Live Poultry Markets in Guangzhou, China: A Surveillance Report

    PubMed Central

    Yuan, Jun; Liu, Hui; Lu, Jianyun; Di, Biao; Xiao, Xincai

    2014-01-01

    Purpose A virologic surveillance program for A(H7N9) virus was conducted from April 15, 2013 to February 14, 2014 in Guangzhou, aiming to clarify the geographical distribution of A(H7N9) viruses among live poultry markets (LPMs) and poultry farms in Guangzhou. Virological and serological surveys of poultry workers were also conducted to evaluate the risk of poultry-to-human transmission of the A(H7N9) virus. Methods 36 retail LPMs, 6 wholesale LPMs and 8 poultry farms were involved in our surveillance program. About 20 live poultry and environmental samples were obtained from each surveillance site at every sampling time. Different environmental samples were collected to represent different poultry-related work activities. RT-PCR and virus culture were performed to identify the A(H7N9) virus. Hemagglutinin inhibition assay and RT-PCR were conducted to detect possible A(H7N9) infection among poultry workers. Results A total of 8900 live poultry and environmental samples were collected, of which 131(1.5%) were tested positive for A(H7N9) virus. 44.4% (16/36) of retail LPMs and 50.0% (3/6) of wholesale LPMs were confirmed to be contaminated. No positive samples was detected from poultry farms. A significant higher positive sample rate was found in environmental samples related to poultry selling (2.6%) and slaughtering (2.4%), compared to poultry holding (0.9%). Correspondingly, A(H7N9) viruses were isolated most frequently from slaughter zone. In addition, 316 poultry workers associated with the 19 contaminated-LPMs were recruited and a low seroprevalence (1.6%) of antibody against A(H7N9) virus was detected. An asymptomatic A(H7N9) infection was also identified by RT-PCR. Conclusions Our study highlights the importance of conducting effective surveillance for A(H7N9) virus and provides evidence to support the assumption that slaughtering is the key process for the propagation of A(H7N9) virus in retail LPMs. Moreover, the ability of A(H7N9) virus to cross species

  15. Detection of avian influenza A(H7N9) virus from live poultry markets in Guangzhou, China: a surveillance report.

    PubMed

    Chen, Zongqiu; Li, Kuibiao; Luo, Lei; Lu, Enjie; Yuan, Jun; Liu, Hui; Lu, Jianyun; Di, Biao; Xiao, Xincai; Yang, Zhicong

    2014-01-01

    A virologic surveillance program for A(H7N9) virus was conducted from April 15, 2013 to February 14, 2014 in Guangzhou, aiming to clarify the geographical distribution of A(H7N9) viruses among live poultry markets (LPMs) and poultry farms in Guangzhou. Virological and serological surveys of poultry workers were also conducted to evaluate the risk of poultry-to-human transmission of the A(H7N9) virus. 36 retail LPMs, 6 wholesale LPMs and 8 poultry farms were involved in our surveillance program. About 20 live poultry and environmental samples were obtained from each surveillance site at every sampling time. Different environmental samples were collected to represent different poultry-related work activities. RT-PCR and virus culture were performed to identify the A(H7N9) virus. Hemagglutinin inhibition assay and RT-PCR were conducted to detect possible A(H7N9) infection among poultry workers. A total of 8900 live poultry and environmental samples were collected, of which 131(1.5%) were tested positive for A(H7N9) virus. 44.4% (16/36) of retail LPMs and 50.0% (3/6) of wholesale LPMs were confirmed to be contaminated. No positive samples was detected from poultry farms. A significant higher positive sample rate was found in environmental samples related to poultry selling (2.6%) and slaughtering (2.4%), compared to poultry holding (0.9%). Correspondingly, A(H7N9) viruses were isolated most frequently from slaughter zone. In addition, 316 poultry workers associated with the 19 contaminated-LPMs were recruited and a low seroprevalence (1.6%) of antibody against A(H7N9) virus was detected. An asymptomatic A(H7N9) infection was also identified by RT-PCR. Our study highlights the importance of conducting effective surveillance for A(H7N9) virus and provides evidence to support the assumption that slaughtering is the key process for the propagation of A(H7N9) virus in retail LPMs. Moreover, the ability of A(H7N9) virus to cross species barrier is proved to be still limited.

  16. Screening for Colorectal Cancer With Fecal Immunochemical Testing With and Without Postpolypectomy Surveillance Colonoscopy: A Cost-Effectiveness Analysis.

    PubMed

    Greuter, Marjolein J E; de Klerk, Clasine M; Meijer, Gerrit A; Dekker, Evelien; Coupé, Veerle M H

    2017-10-03

    Population-based screening to prevent colorectal cancer (CRC) death is effective, but the effectiveness of postpolypectomy surveillance is unclear. To evaluate the additional benefit in terms of cost-effectiveness of colonoscopy surveillance in a screening setting. Microsimulation using the ASCCA (Adenoma and Serrated pathway to Colorectal CAncer) model. Dutch CRC screening program and published literature. Asymptomatic persons aged 55 to 75 years without a prior CRC diagnosis. Lifetime. Health care payer. Fecal immunochemical test (FIT) screening with colonoscopy surveillance performed according to the Dutch guideline was simulated. The comparator was no screening or surveillance. FIT screening without colonoscopy surveillance and the effect of extending surveillance intervals were also evaluated. CRC burden, colonoscopy demand, life-years, and costs. FIT screening without surveillance reduced CRC mortality by 50.4% compared with no screening or surveillance. Adding surveillance to FIT screening reduced mortality by an additional 1.7% to 52.1% but increased lifetime colonoscopy demand by 62% (from 335 to 543 colonoscopies per 1000 persons) at an additional cost of €68 000, for an increase of 0.9 life-year. Extending the surveillance intervals to 5 years reduced CRC mortality by 51.8% and increased colonoscopy demand by 42.7% compared with FIT screening without surveillance. In an incremental analysis, incremental cost-effectiveness ratios (ICERs) for screening plus surveillance exceeded the Dutch willingness-to-pay threshold of €36 602 per life-year gained. When using a parameter set representing low colorectal lesion prevalence or when colonoscopy costs were halved or colorectal lesion incidence was doubled, screening plus surveillance became cost-effective compared with screening without surveillance. Limited data on FIT performance and background CRC risk in the surveillance population. Adding surveillance to FIT screening is not cost-effective based on

  17. 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.

  18. Role of the post-marketing authorisation studies in drug risk surveillance: specifications and methodologies.

    PubMed

    Tubach, Florence; Lamarque-Garnier, Véronique; Castot, Anne

    2011-01-01

    Studies conducted after the marketing authorisation with the objective of identification, characterization or quantification of one or more risks (called PASS "Post-Authorisation Safety Studies"), have been strengthened in the past years with the implementation of the concept of risk management plans (RMPs), established in 2005 in the European regulatory framework and recently amended as part of the community revision. These safety studies, interventional or not, are related to a marketed drug, whether or not the drug is used within the market authorisation conditions. Apart from these safety studies, other studies whose primary objective is not risk assessment, including assessment of efficacy, description of prescription data and use in real life, pharmacokinetics, public health impact ... can complete available safety data.The Giens Round Table examined PASS from the risk management plans of a sample of marketing authorisation holders (participants to the Round Table) and identified the main characteristics of proposed actions. Concerning the specifications and the choice of methodology, only a general outline has been sketched in view of the complexity and diversity of drug risks situations.

  19. Can remote STI/HIV testing and eClinical Care be compatible with robust public health surveillance?

    PubMed Central

    Harding-Esch, Emma; Nardone, Anthony; Gibbs, Jo; Sutcliffe, Lorna; Sonnenberg, Pam; Estcourt, Claudia; Hughes, Gwenda; Mohammed, Hamish; Gill, Noel; Sadiq, S Tariq; Lowndes, Catherine

    2015-01-01

    In this paper we outline the current data capture systems for human immunodeficiency virus (HIV) and sexually transmitted infection (STI) surveillance used by Public Health England (PHE), and how these will be affected by the introduction of novel testing platforms and changing patient pathways. We outline the Chlamydia Online Clinical Care Pathway (COCCP), developed as part of the Electronic Self-Testing for Sexually Transmitted Infections (eSTI2) Consortium, which ensures that surveillance data continue to be routinely collected and transmitted to PHE. We conclude that both novel diagnostic testing platforms and established data capture systems must be adaptable to ensure continued robust public health surveillance. PMID:26742547

  20. 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.

  1. Testing for detailed balance in a financial market

    NASA Astrophysics Data System (ADS)

    Fiebig, H. R.; Musgrove, D. P.

    2015-06-01

    We test a historical price-time series in a financial market (the NASDAQ 100 index) for a statistical property known as detailed balance. The presence of detailed balance would imply that the market can be modeled by a stochastic process based on a Markov chain, thus leading to equilibrium. In economic terms, a positive outcome of the test would support the efficient market hypothesis, a cornerstone of neo-classical economic theory. In contrast to the usage in prevalent economic theory the term equilibrium here is tied to the returns, rather than the price-time series. The test is based on an action functional S constructed from the elements of the detailed balance condition and the historical data set, and then analyzing S by means of simulated annealing. Checks are performed to verify the validity of the analysis method. We discuss the outcome of this analysis.

  2. [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

  3. Avian Influenza H5N1 Surveillance and its Dynamics in Poultry in Live Bird Markets, Egypt.

    PubMed

    ElMasry, I; Elshiekh, H; Abdlenabi, A; Saad, A; Arafa, A; Fasina, F O; Lubroth, J; Jobre, Y M

    2015-11-25

    H5N1, a highly pathogenic avian influenza (H5N1 HPAI), is an endemic disease that is significant for public health in Egypt. Live bird markets (LBMs) are widespread in Egypt and play an important role in HPAI disease dynamics. The aim of the study was to evaluate the H5N1 HPAI prevalence in representative LBMs from 2009 to 2014, assess the effects of other variables and evaluate past outbreaks and human cases. It was found that ducks and geese are high-risk species and that the prevalence of H5N1 HPAI was higher immediately after the political crises of 2011. The end of a calendar year (June to December) was a high-risk period for positive samples, and the risk in urban LBMs was twice the risk in rural LBMs. Winter and political unrest was associated with higher H5N1 HPAI prevalence. Both human and poultry populations will continue to rise in Egypt, so continued poultry outbreaks are likely to be linked to more human cases. LBMs will continue to play a role in the dynamics of poultry disease in Egypt, and there is a need to reorganize markets in terms of biosecurity and traceability. It may also be beneficial to reduce inter-governorate inter-regional movements associated with poultry trade through promotion of regional trade or in the alternative provide sanitary features along the poultry market chain to reduce the speed of H5N1 HPAI infections. Policy formulation, design and enforcement must be pro-poor, and consideration of the sociocultural and economic realities in Egypt is important. The LBMs provide ideal platforms to carry out sound surveillance plans and mitigate zoonotic risks of H5N1 HPAI to humans.

  4. 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

  5. [Evaluation of the test results on hepatitis B pilot surveillance labortory in 9 provinces of China].

    PubMed

    Wang, Fu-zhen; Cui, Fu-qiang; Gong, Xiao-hong

    2010-06-01

    To assess the test quality of HBsAg, anti-HBc IgM and anti-HAV IgM in the laboratories of Hepatitis B pilot surveillance provinces. Blood serum from each of the Hepatitis B pilot surveillance provinces were collected to verify the test results. The Chemiluminescence Microparticle Immuno Assay (CMIA), ARCHITECT i2000 automatic light detector and test reagents produced by U.S.A. Abbott corporation were used in the retest. Using the Abbott reagent CMIA test results as the criteria, the domestic made ELISA reagents sensitivity, specificity, the total coincidence rate and Yoden index of HBsAg, anti-HBc IgM and anti-HAV IgM were evaluated in Hepatitis B pilot surveillance provinces. In the National Notifiable Diseases Reporting System (NNDRS) reported Hepatitis B cases, the proportion of detecting HBsAg and anti-HBc IgM was 98.53% and 39.49% respectively. Through the verification test to the reported cases in Hepatitis B pilot surveillance provinces, the original and veritication diagnosis 01 the reported eases was quite different. Among 197 acute Hepatitis B reported cases, 56 cases were agreeable with diagnosis cretirea, accounting for 28.42%. Among 1046 chronic Hepatitis B reported cases, the verification diagnosis of 602 cases was consistent with the original diagnosis, accounting for 57.55%. By using Abbott reagent and CMIA method to test again, it was found that the verification test results using domesticmade reagent and ELISA assay were low consistency compared with the test results of Abbott reagent CMIA method. The detection result of home-made reagents by ELISA compared with the Abbott reagents CMIA, the sensitivity and the total coincidence rate of HBsAg were over 95%, Kappa value was 0.439, and specificity was only 50.00%. The sensitivity, the total coincidence rate and the specificity of Anti-HBc IgM were moderate level, Kappa value was 0.516. The sensitivity of Anti-HAV IgM were 20%, and the total coincidence and specificity were higher, Kappa value was 0

  6. Potential Biases Introduced by Conflating Screening and Diagnostic Testing in Colorectal Cancer Screening Surveillance.

    PubMed

    Becker, Elizabeth A; Griffith, Derek M; West, Brady T; Janz, Nancy K; Resnicow, Ken; Morris, Arden M

    2015-12-01

    Screening and postsymptomatic diagnostic testing are often conflated in cancer screening surveillance research. We examined the error in estimated colorectal cancer screening prevalence due to the conflation of screening and diagnostic testing. Using data from the 2008 National Health Interview Survey, we compared weighted prevalence estimates of the use of all testing (screening and diagnostic) and screening in at-risk adults and calculated the overestimation of screening prevalence across sociodemographic groups. The population screening prevalence was overestimated by 23.3%, and the level of overestimation varied widely across sociodemographic groups (median, 22.6%; mean, 24.8%). The highest levels of overestimation were in non-Hispanic white females (27.4%), adults ages 50-54 years (32.0%), and those with the highest socioeconomic vulnerability [low educational attainment (31.3%), low poverty ratio (32.5%), no usual source of health care (54.4%), and not insured (51.6%); all P < 0.001]. When the impetus for testing was not included, colorectal cancer screening prevalence was overestimated, and patterns of overestimation often aligned with social and economic vulnerability. These results are of concern to researchers who use survey data from the Behavioral Risk Factor Surveillance System (BRFSS) to assess cancer screening behaviors, as it is currently not designed to distinguish diagnostic testing from screening. Surveillance research in cancer screening that does not consider the impetus for testing risks measurement error of screening prevalence, impeding progress toward improving population health. Ultimately, to craft relevant screening benchmarks and interventions, we must look beyond "what" and "when" and include "why." ©2015 American Association for Cancer Research.

  7. Improving national surveillance of Lyme neuroborreliosis in Denmark through electronic reporting of specific antibody index testing from 2010 to 2012.

    PubMed

    Dessau, R B; Espenhain, L; Mølbak, K; Krause, T G; Voldstedlund, M

    2015-07-16

    Our aim was to evaluate the results of automated surveillance of Lyme neuroborreliosis (LNB) in Denmark using the national microbiology database (MiBa), and to describe the epidemiology of laboratory-confirmed LNB at a national level. MiBa-based surveillance includes electronic transfer of laboratory results, in contrast to the statutory surveillance based on manually processed notifications. Antibody index (AI) testing is the recommend laboratory test to support the diagnosis of LNB in Denmark. In the period from 2010 to 2012, 217 clinical cases of LNB were notified to the statutory surveillance system, while 533 cases were reported AI positive by the MiBa system. Thirty-five unconfirmed cases (29 AI-negative and 6 not tested) were notified, but not captured by MiBa. Using MiBa, the number of reported cases was increased almost 2.5 times. Furthermore, the reporting was timelier (median lag time: 6 vs 58 days). Average annual incidence of AI-confirmed LNB in Denmark was 3.2/100,000 population and incidences stratified by municipality ranged from none to above 10/100,000. This is the first study reporting nationwide incidence of LNB using objective laboratory criteria. Laboratory-based surveillance with electronic data-transfer was more accurate, complete and timely compared to the surveillance based on manually processed notifications. We propose using AI test results for LNB surveillance instead of clinical reporting.

  8. 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.

  9. 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

  10. 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

  11. Testing market informational efficiency of Constanta port operators

    NASA Astrophysics Data System (ADS)

    Roşca, E.; Popa, M.; Ruscă, F.; Burciu, Ş.

    2015-11-01

    The Romanian capital market is still an emergent one. Following the mass- privatization process and the private investments, three of the most important handling and storage companies acting in Constantza Port (OIL Terminal, Comvex and SOCEP) are listed on Romanian Stock Exchange. The paper investigates their evolution on the market, identifying the expected rate of return and the components of the shares risk (specific and systematic). Also, the price evolution could be analyzed through the informational efficiency which instantly reflects the price relevance. The Jarque-Bera normality test regarding the shares return rate distribution and the Fama test for the informational efficiency are completed for each company. The market price model is taken into consideration for price forecasting, computing the return rate auto-correlations. The results are subject of interpretation considering additional managerial and financial information of the companies’ activity.

  12. What we learn from surveillance testing of standby turbine driven and motor driven pumps

    SciTech Connect

    Christie, B.

    1996-12-01

    This paper describes a comparison of the performance information collected by the author and the respective system engineers from five standby turbine driven pumps at four commercial nuclear electric generating units in the United States and from two standby motor driven pumps at two of these generating units. Information was collected from surveillance testing and from Non-Test actuations. Most of the performance information (97%) came from surveillance testing. {open_quotes}Conditional Probabilities{close_quotes} of the pumps ability to respond to a random demand were calculated for each of the seven standby pumps and compared to the historical record of the Non-Test actuations. It appears that the Conditional Probabilities are comparable to the rate of success for Non-Test actuations. The Conditional Probabilities of the standby motor driven pumps (approximately 99%) are better than the Conditional Probabilities of the standby turbine driven pumps (82%-96% range). Recommendations were made to improve the Conditional Probabilities of the standby turbine driven pumps.

  13. Advanced Marketing Core Curriculum. Test Items and Assessment Techniques.

    ERIC Educational Resources Information Center

    Smith, Clifton L.; And Others

    This document contains duties and tasks, multiple-choice test items, and other assessment techniques for Missouri's advanced marketing core curriculum. The core curriculum begins with a list of 13 suggested textbook resources. Next, nine duties with their associated tasks are given. Under each task appears one or more citations to appropriate…

  14. Post-marketing surveillance of methadone and buprenorphine in the United States.

    PubMed

    Dasgupta, Nabarun; Bailey, Elise J; Cicero, Theodore; Inciardi, James; Parrino, Mark; Rosenblum, Andrew; Dart, Richard C

    2010-07-01

    There have been recent increases in the use of methadone and buprenorphine in the United States. Methadone is increasingly being used for pain management, and buprenorphine use has expanded to include treatment for opioid addiction, leading to exposures of these drugs in new populations. There is a debate about the relative safety of these two drugs in routine outpatient medical use. Data from the Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System Programs were used to analyze rates of abuse, misuse, and diversion using the Drug Diversion, Key Informant, Poison Center and Opioid Treatment Programs, 2003-2007. National rate and rate ratios were calculated using population and person-time exposed denominators. Detailed data are presented on severity of medical outcome and drug formulations. Between 2003 and 2007, there were steady increases in the rates of abuse, misuse, and diversion of both methadone and buprenorphine. Rate ratios (per 100,000 population per quarter) of abuse, misuse, and diversion were consistently higher for methadone than buprenorphine. RADARS System poison centers received 7,476 calls for methadone and 1,117 calls for buprenorphine. After accounting for availability, there were higher rates of calls for methadone misuse, abuse, and diversion than buprenorphine in three of the four programs. The numbers of exposures requiring medical attention correspond to 46.8% and 25.8% of all calls, for methadone and buprenorphine, respectively. The most commonly diverted form of methadone was solid oral tablets (which are typically dispensed at pharmacies, not at opioid treatment programs), comprising 73% of cases. Buprenorphine appears to have a better safety profile than methadone during routine outpatient medical use. However, both medications have roles in the treatment of pain and opioid addiction, and further research into their respective benefits and risks should be conducted.

  15. Post-marketing surveillance of CustomBone Service implanted in children under 7 years old.

    PubMed

    Frassanito, Paolo; Tamburrini, Gianpiero; Massimi, Luca; Di Rocco, Concezio; Nataloni, Angelo; Fabbri, Greta; Caldarelli, Massimo

    2015-01-01

    The CustomBone Service is a bioceramic implant suitable for cranial repair in both adults and children, although there are no clinical data about its use in children under 7 years of age. This surveillance study investigates the outcome in this age group. Twenty-eight children under 7 years old (range, 2.5-6 years) received CustomBone Service from July 2006 to May 2013 in 16 international hospitals. Data of 23 children (12 males and 11 females), harboring 24 prosthesis, were available with a minimum follow-up of 1 year. Sites of the cranial defect were frontal or parietal (20.8 % each), parieto-temporal (16.7 %), fronto-parietal or occipital (12.5 % each), fronto-parieto-temporal or fronto-temporal (8.3 % each). Initial diseases were trauma (54.2 %), malformation (37.5 %), or tumor of the bone/skin (8.3 %). Rupture of the implant occurred in a single case during the implant (1/26 surgeries, 3.8 %) and the cranial repair was achieved by means of the back-up prosthesis. Five adverse events were registered during the follow-up period consisting of three cases of fracture and two of exposure/infection of the prosthesis. All cases required the removal of the device (20.8 %). The failure rate of CustomBone Service under 7 years of age was higher than reported in adults and children over 7 years old (20.8 vs. 3.8 %), However, CustomBone Service may be considered a valid option under 7 years old since other materials are burdened by more significant rates of complications in the long-term period. Due to specific properties of this material, indication to CustomBone Service in toddlers should be carefully evaluated by the surgeon on a case-by-case basis.

  16. 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

  17. Agricultural factor markets in Sub-Saharan Africa: An updated view with formal tests for market failure.

    PubMed

    Dillon, Brian; Barrett, Christopher B

    2017-02-01

    This paper uses the recently collected Living Standard Measurement Study-Integrated Surveys on Agriculture Initiative data sets from five countries in Sub-Saharan Africa to provide a comprehensive overview of factor market participation by agrarian households and to formally test for failures in rural markets. Under complete and competitive markets, households can solve their consumption and production problems separately, so that household factor endowments do not predict input demand. This paper implements a simple, theoretically grounded test of this separation hypothesis, which can be interpreted as a reduced form test of market failure. In all five study countries, the analysis finds strong evidence of factor market failure. Moreover, those failures appear general and structural, not specific to subpopulations defined by gender, geography, human capital, or land quality. However, we show that rural markets are not generally missing in an absolute sense, suggesting that market existence is less of a problem than market function.

  18. 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.

  19. [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.

  20. 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.

  1. 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.

  2. 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.

  3. In-orbit test, verification and surveillance of the laser communication system

    NASA Astrophysics Data System (ADS)

    Sun, Jianfeng; Wang, Biao; Fei, Ligang; Zhang, Changquan; Liu, Liren

    2015-10-01

    To perform the in-orbit test, verification and surveillance task, the laser simulation and test station must be constructed. Cooperated with the fixed laser communication ground station, we can not only test the main specifications of the laser communication terminals, but also test the performances of the laser backbone link. In this paper, we first give the basic theory of the in-orbit test. Then designed the laser simulation and test station, which consists of laser transmitter module, laser receiver module, and general test module. In the GEO-to-LEO laser communication terminal test progress, the laser simulation and test station responsible for the simulation of the LEO laser communication terminal. In the LEO-GEO-Ground laser link performance test progress, the laser simulation and test station simulate the LEO satellite, which transfer high date rate data flow to GEO satellite, then the GEO satellite route the data flow to the GEO-to-Ground laser communication terminal through optical router, finally GEO satellite transfer the LEO data down to fixed laser receiver on ground.

  4. Head Lice Surveillance on a Deregulated OTC-Sales Market: A Study Using Web Query Data

    PubMed Central

    Lindh, Johan; Magnusson, Måns; Grünewald, Maria; Hulth, Anette

    2012-01-01

    The head louse, Pediculus humanus capitis, is an obligate ectoparasite that causes infestations of humans. Studies have demonstrated a correlation between sales figures for over-the-counter (OTC) treatment products and the number of humans with head lice. The deregulation of the Swedish pharmacy market on July 1, 2009, decreased the possibility to obtain complete sale figures and thereby the possibility to obtain yearly trends of head lice infestations. In the presented study we wanted to investigate whether web queries on head lice can be used as substitute for OTC sales figures. Via Google Insights for Search and Vårdguiden medical web site, the number of queries on “huvudlöss” (head lice) and “hårlöss” (lice in hair) were obtained. The analysis showed that both the Vårdguiden series and the Google series were statistically significant (p<0.001) when added separately, but if the Google series were already included in the model, the Vårdguiden series were not statistically significant (p = 0.5689). In conclusion, web queries can detect if there is an increase or decrease of head lice infested humans in Sweden over a period of years, and be as reliable a proxy as the OTC-sales figures. PMID:23144923

  5. Head lice surveillance on a deregulated OTC-sales market: a study using web query data.

    PubMed

    Lindh, Johan; Magnusson, Måns; Grünewald, Maria; Hulth, Anette

    2012-01-01

    The head louse, Pediculus humanus capitis, is an obligate ectoparasite that causes infestations of humans. Studies have demonstrated a correlation between sales figures for over-the-counter (OTC) treatment products and the number of humans with head lice. The deregulation of the Swedish pharmacy market on July 1, 2009, decreased the possibility to obtain complete sale figures and thereby the possibility to obtain yearly trends of head lice infestations. In the presented study we wanted to investigate whether web queries on head lice can be used as substitute for OTC sales figures. Via Google Insights for Search and Vårdguiden medical web site, the number of queries on "huvudlöss" (head lice) and "hårlöss" (lice in hair) were obtained. The analysis showed that both the Vårdguiden series and the Google series were statistically significant (p<0.001) when added separately, but if the Google series were already included in the model, the Vårdguiden series were not statistically significant (p = 0.5689). In conclusion, web queries can detect if there is an increase or decrease of head lice infested humans in Sweden over a period of years, and be as reliable a proxy as the OTC-sales figures.

  6. 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.

  7. 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.

  8. The AEDC aerospace chamber 7V: An advanced test capability for infrared surveillance and seeker sensors

    NASA Technical Reports Server (NTRS)

    Simpson, W. R.

    1994-01-01

    An advanced sensor test capability is now operational at the Air Force Arnold Engineering Development Center (AEDC) for calibration and performance characterization of infrared sensors. This facility, known as the 7V, is part of a broad range of test capabilities under development at AEDC to provide complete ground test support to the sensor community for large-aperture surveillance sensors and kinetic kill interceptors. The 7V is a state-of-the-art cryo/vacuum facility providing calibration and mission simulation against space backgrounds. Key features of the facility include high-fidelity scene simulation with precision track accuracy and in-situ target monitoring, diffraction limited optical system, NIST traceable broadband and spectral radiometric calibration, outstanding jitter control, environmental systems for 20 K, high-vacuum, low-background simulation, and an advanced data acquisition system.

  9. 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.

  10. Direct to confusion: lessons learned from marketing BRCA testing.

    PubMed

    Matloff, Ellen; Caplan, Arthur

    2008-06-01

    Myriad Genetics holds a patent on testing for the hereditary breast and ovarian cancer genes, BRCA1 and BRCA2, and therefore has a forced monopoly on this critical genetic test. Myriad launched a Direct-to-Consumer (DTC) marketing campaign in the Northeast United States in September 2007 and plans to expand that campaign to Florida and Texas in 2008. The ethics of Myriad's patent, forced monopoly and DTC campaign will be reviewed, as well as the impact of this situation on patient access and care, physician liability, and the future of DTC campaigns for genetic testing.

  11. Unequal a priori probability multiple hypothesis testing in space domain awareness with the space surveillance telescope.

    PubMed

    Hardy, Tyler; Cain, Stephen; Blake, Travis

    2016-05-20

    This paper investigates the ability to improve Space Domain Awareness (SDA) by increasing the number of detectable Resident Space Objects (RSOs) from space surveillance sensors. With matched filter based techniques, the expected impulse response, or Point Spread Function (PSF), is compared against the received data. In the situation where the images are spatially undersampled, the modeled PSF may not match the received data if the RSO does not fall in the center of the pixel. This aliasing can be accounted for with a Multiple Hypothesis Test (MHT). Previously, proposed MHTs have implemented a test with an equal a priori prior probability assumption. This paper investigates using an unequal a priori probability MHT. To determine accurate a priori probabilities, three metrics are computed; they are correlation, physical distance, and empirical. Using the calculated a priori probabilities, a new algorithm is developed, and images from the Space Surveillance Telescope (SST) are analyzed. The number of detected objects by both an equal and unequal prior probabilities are compared while keeping the false alarm rate constant. Any additional number of detected objects will help improve SDA capabilities.

  12. An Algorithm for Testing the Efficient Market Hypothesis

    PubMed Central

    Boboc, Ioana-Andreea; Dinică, Mihai-Cristian

    2013-01-01

    The objective of this research is to examine the efficiency of EUR/USD market through the application of a trading system. The system uses a genetic algorithm based on technical analysis indicators such as Exponential Moving Average (EMA), Moving Average Convergence Divergence (MACD), Relative Strength Index (RSI) and Filter that gives buying and selling recommendations to investors. The algorithm optimizes the strategies by dynamically searching for parameters that improve profitability in the training period. The best sets of rules are then applied on the testing period. The results show inconsistency in finding a set of trading rules that performs well in both periods. Strategies that achieve very good returns in the training period show difficulty in returning positive results in the testing period, this being consistent with the efficient market hypothesis (EMH). PMID:24205148

  13. An algorithm for testing the efficient market hypothesis.

    PubMed

    Boboc, Ioana-Andreea; Dinică, Mihai-Cristian

    2013-01-01

    The objective of this research is to examine the efficiency of EUR/USD market through the application of a trading system. The system uses a genetic algorithm based on technical analysis indicators such as Exponential Moving Average (EMA), Moving Average Convergence Divergence (MACD), Relative Strength Index (RSI) and Filter that gives buying and selling recommendations to investors. The algorithm optimizes the strategies by dynamically searching for parameters that improve profitability in the training period. The best sets of rules are then applied on the testing period. The results show inconsistency in finding a set of trading rules that performs well in both periods. Strategies that achieve very good returns in the training period show difficulty in returning positive results in the testing period, this being consistent with the efficient market hypothesis (EMH).

  14. Evaluation of an automated safety surveillance system using risk adjusted sequential probability ratio testing

    PubMed Central

    2011-01-01

    Background Automated adverse outcome surveillance tools and methods have potential utility in quality improvement and medical product surveillance activities. Their use for assessing hospital performance on the basis of patient outcomes has received little attention. We compared risk-adjusted sequential probability ratio testing (RA-SPRT) implemented in an automated tool to Massachusetts public reports of 30-day mortality after isolated coronary artery bypass graft surgery. Methods A total of 23,020 isolated adult coronary artery bypass surgery admissions performed in Massachusetts hospitals between January 1, 2002 and September 30, 2007 were retrospectively re-evaluated. The RA-SPRT method was implemented within an automated surveillance tool to identify hospital outliers in yearly increments. We used an overall type I error rate of 0.05, an overall type II error rate of 0.10, and a threshold that signaled if the odds of dying 30-days after surgery was at least twice than expected. Annual hospital outlier status, based on the state-reported classification, was considered the gold standard. An event was defined as at least one occurrence of a higher-than-expected hospital mortality rate during a given year. Results We examined a total of 83 hospital-year observations. The RA-SPRT method alerted 6 events among three hospitals for 30-day mortality compared with 5 events among two hospitals using the state public reports, yielding a sensitivity of 100% (5/5) and specificity of 98.8% (79/80). Conclusions The automated RA-SPRT method performed well, detecting all of the true institutional outliers with a small false positive alerting rate. Such a system could provide confidential automated notification to local institutions in advance of public reporting providing opportunities for earlier quality improvement interventions. PMID:22168892

  15. 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.

  16. 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.

  17. 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.

  18. [Surveillance on severe acute respiratory syndrome associated coronavirus in animals at a live animal market of Guangzhou in 2004].

    PubMed

    Wang, Ming; Jing, Huai-qi; Xu, Hui-fang; Jiang, Xiu-gao; Kan, Biao; Liu, Qi-yong; Wan, Kang-lin; Cui, Bu-yun; Zheng, Han; Cui, Zhi-gang; Yan, Mei-ying; Liang, Wei-li; Wang, Hong-xia; Qi, Xiao-bao; Li, Zhen-jun; Li, Ma-chao; Chen, Kai; Zhang, En-min; Zhang, Shou-yin; Hai, Rong; Yu, Dong-zheng; Xu, Jian-guo

    2005-02-01

    To study the prevalence of severe acute respiratory syndrome coronavirus (SARS-CoV) like virus in animals at a live animal market of Guanzhou in 2004 before and after culling of wild animal action taken by the local authority, in order to predict the re-emerging of SARS from animal originals in this region. Animals at live animal market were sampled for rectal and throat swabs in triplicate. A single step realtime reverse transcription-polymerase chain reaction (RT-PCR) diagnostic kit was performed for screening SARS-CoV like virus, the manual nested RT- PCR and DNA sequencing were performed for confirmation. Only specimens which tested positive for both of the N and P genes by nested RT-PCR were scored as positive. In 31 animals sampled in January 5 2004 before culling of wild animals at Guangdong Province, including 20 cats (Felis catus), 5 red fox (Vulpes vulpes) and 6 Lesser rice field rats (Rattus losea), 8 (25.8%) animals were tested positive for SARS-CoV like virus by RT-PCR methods, of which 4 cats, 3 red fox and one Lesser rice field rats were included. However, two weeks after culling of animals and disinfection of the market were implemented, in 119 animals sampled in January 20 2004, including 6 rabbits (Oryctolagus cuniculus), 13 cats, 46 red jungle fowl (Gallus gallus), 13 spotbill duck (Anas platyrhynchos), 10 greylag goose (Anser anser), 31 Chinese francolin (Franclinus pintadeanus), only rectal swab from one greylag goose was tested positive for SARS-CoV like virus. Furthermore, in 102 animals that including 14 greylag gooses, 3 cats, 5 rabbits, 9 spotbill duck (Anaspoecilorhyncha), 2 Chinese francolin (Franclinus pintadeanus), 8 common pheasant (Phasianus colchicus), 6 pigeons, 9 Chinese muntjac (Muntiacus reevesi), 19 wild boar (Sus scrofa), 16 Lesser rice field rats, 5 dogs, 1 mink (Mustela vison), 3 goats, 2 green peafowl (Pavo muticus) sampled in April, May, June, July, August and November, only rectal swab from one pig was tested positive

  19. 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

  20. RELATIVE HUMIDITY TESTS IN SUPPORT OF THE 3013 STORAGE AND SURVEILLANCE PROGRAM

    SciTech Connect

    Mickalonis, J.; Duffey, J.

    2011-08-01

    Techniques to control the initial relative humidity over oxide/salt mixtures have been developed using cerium oxide as a surrogate for plutonium oxide. Such control is required to validate certain assumptions in the Department of Energy Standard DOE-STD-3013, and to provide essential information to support field surveillance at the storage sites for excess plutonium oxides. Concern over the validity of the assumption that corrosion induced degradation in 3013 containers could be controlled by assuring that the moisture content of any stored oxide/salt mixture was below 0.5 w t% arose when stress corrosion cracks were found in test samples exposed at room temperature to plutonium oxide/salt mixtures having a moisture content only marginally above 0.5 wt %. Additionally, analysis of the stress corrosion cracking observations suggests that the initial relative humidity over the oxide/salt mixture may play a major role in the cracking process. The investigations summarized in this report provide the procedures necessary to control the initial relative humidity to selected values within the range of 16 to 50% by controlling the loading relative humidity (18 to 60%) and the oxide/salt mixture water content (0.05 to 0.45 wt %). The studies also demonstrated that the initial relative humidity may be estimated by calculations using software EQ3/6. Cerium oxide/salt mixtures were used in this study because qualification tests with non-radioactive materials will reduce costs while increasing the breadth of the test programs required to support field surveillances of stored 3013 containers.

  1. The development of an artificial stool usable for the surveillance of faecal haemoglobin testing.

    PubMed

    Miike, Akira; Ogawa, Zensuke; Sakurabayashi, Ikunosuke

    2017-01-01

    Background Faecal occult blood testing is an important diagnostic tool for the detection of colorectal cancer. However, it has not been standardized due to the absence of suitable specimens for surveillance. Methods We developed a ready-to-use artificial stool made from rice flour. This new artificial stool homogeneously contains not only human haemoglobin A0 (HbA0) but also glycerol as an internal standard material. After the collection of the artificial stool into a buffer, the haemoglobin concentration in dispersed solution was measured using a method based on the peroxidase like activity of haemoglobin. The glycerol concentration was measured using a commercially available triglyceride measurement kit. Results With regard to the haemoglobin stability, the decrease in the level of human haemoglobin in the artificial stool was <2% when it was stored at -80℃ for four months, -20℃ for two weeks, and 5℃ for two days. The artificial stool was easily collected with the collecting tubes of a commercially available faecal haemoglobin test kit. The weight of the collected artificial stool could be calculated by measuring the concentration of glycerol in the extracting solution of the collected stool sample. The haemoglobin concentrations could be adjusted based on their collection weights. Conclusions The artificial stool has a paste-like consistency and contains both haemoglobin and glycerol homogeneously. Furthermore, the measured haemoglobin concentration could be determined based on the collected stool weight, which was directly related to the glycerol concentration. These features make it a useful material for the surveillance of faecal occult blood testing.

  2. Routine data from prevention of mother-to-child transmission (PMTCT) HIV testing not yet ready for HIV surveillance in Mozambique: a retrospective analysis of matched test results

    PubMed Central

    2013-01-01

    Background Opt-out HIV testing is offered at 70% of antenatal care (ANC) clinics in Mozambique through the prevention of mother-to-child transmission (PMTCT) program. If routine data from this program were of sufficient quality, their heightened coverage and continuous availability could complement or even replace biannual sentinel serosurveys that currently serve as the primary HIV surveillance system in Mozambique. Methods We assessed the efficacy of routine HIV testing data from prevention of mother-to-child transmission programs for estimating the prevalence of HIV infection among pregnant women. The PMTCT program uses sequential point-of-care rapid tests conducted on site while ANC surveillance surveys use dried blood spots tested sequentially for HIV-1/2 antibodies at a central laboratory. We compared matched routine PMTCT and ANC surveillance test results collected during 2007 and 2009 ANC surveillance surveys from 36 sentinel sites. Results After excluding 659 women without PMTCT data, including 83 who refused rapid testing, test results from a total of 20,563 women were available. Pooling the data from both years indicated HIV prevalence from routine PMTCT testing was 14.4% versus 15.2% from surveillance testing (relative difference -5.1%; absolute difference -0.78%). Positive percent agreement (PPA) of PMTCT versus surveillance tests was 88.5% (95% Confidence Interval [CI]: 85.7-91.3%), with 19 sites having PPA below 90%; Negative percent agreement (NPA) was 98.9% (CI: 98.5-99.2%). No significant difference was found among three regions (North, Center and South), however both PPA and NPA were significantly higher in 2009 than 2007 (p < 0.05). Conclusions We found low PPA of PMTCT test results compared to surveillance data which is indicative either of testing errors or data reporting problems. Nonetheless, PPA improved significantly from 2007 to 2009, a possible positive trend that should be investigated further. Although use of PMTCT test results

  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. Development and test of video systems for airborne surveillance of oil spills

    NASA Technical Reports Server (NTRS)

    Millard, J. P.; Arvesen, J. C.; Lewis, P. L.

    1975-01-01

    Five video systems - potentially useful for airborne surveillance of oil spills - were developed, flight tested, and evaluated. The systems are: (1) conventional black and white TV, (2) conventional TV with false color, (3) differential TV, (4) prototype Lunar Surface TV, and (5) field sequential TV. Wavelength and polarization filtering were utilized in all systems. Greatly enhanced detection of oil spills, relative to that possible with the unaided eye, was achieved. The most practical video system is a conventional TV camera with silicon-diode-array image tube, filtered with a Corning 7-54 filter and a polarizer oriented with its principal axis in the horizontal direction. Best contrast between oil and water was achieved when winds and sea states were low. The minimum detectable oil film thickness was about 0.1 micrometer.

  5. Improving space domain awareness through unequal-cost multiple hypothesis testing in the space surveillance telescope.

    PubMed

    Hardy, Tyler; Cain, Stephen; Jeon, Jae; Blake, Travis

    2015-06-10

    This paper investigates algorithms to improve the detection of space objects with the space surveillance telescope (SST) system. These space objects include natural objects such as asteroids and artificial satellites in Earth orbit. Using a proposed multiple hypothesis test (MHT), the detection performance is compared to the currently used algorithm as well as a matched filter and an equal-cost MHT algorithm. To compare these algorithms, a data set collected by the SST of a geosynchronous Earth orbit satellite, ANIK-F1 entering the Earth's eclipse, is utilized. It is found that an unequal-cost MHT gives increased performance over a point detector, a matched filter, and equal-cost MHT over a large range of potential intensities. Results are presented as probability of detection and receiver operating characteristic curves. In addition, the performance of the algorithm as a function of number of hypotheses used is investigated.

  6. VecTest as Diagnostic and Surveillance Tool for West Nile Virus in Dead Birds

    PubMed Central

    Okoniewski, Joseph C.; Therrien, Joseph E.; Kramer, Laura D.; Kauffman, Elizabeth B.; Eidson, Millicent

    2004-01-01

    The VecTest antigen-capture assay for West Nile virus was performed on oral and tissue swabs from dead birds in New York State from April 2003 through July 2004. Results were compared with those from real-time reverse transcriptase–polymerase chain reaction of kidney or brain. Oral VecTest sensitivity is adequate for surveillance in American Crows (Corvus brachyrhynchos) (87%), Blue Jays (Cyanocitta cristata) (80%), and House Sparrows (Passer domesticus) (76%). Oral VecTest performed well for small samples of American Kestrels (Falco sparverius), Northern Cardinals (Cardinalis cardinalis), Common Grackles (Quiscalus quiscula), and House Finches (Carpodacus mexicanus). Poor sensitivity occurred in most raptors, Mourning Doves (Zenaida macroura), Fish Crows (Corvus ossifragus), and American Robins (Turdus migratorius). Specificity was excellent (98%), except for false-positive results that occurred mostly in Gray Catbirds (Dumatella carolinensis), Green Herons (Butorides virescens), and tests of blood and tissues. Feather pulp and kidney may be useful for VecTest assays in corvids. PMID:15663856

  7. Retrospective hospital based surveillance of intussusception in children in a sentinel paediatric hospital: benefits and pitfalls for use in post-marketing surveillance of rotavirus vaccines.

    PubMed

    Lloyd-Johnsen, C; Justice, F; Donath, S; Bines, J E

    2012-04-27

    Evaluation of the safety of rotavirus vaccines, particularly with respect to the risk of intussusception, is recommended for countries planning to introduce rotavirus vaccines into the National Immunisation Program. However, as prospective studies are costly, require time to conduct and may be difficult to perform in some settings, retrospective hospital based surveillance at sentinel sites has been suggested as an option for surveillance for intussusception following introduction of rotavirus vaccines. To assess the value of retrospective hospital based surveillance to describe clinical and epidemiological features of intussusception in children aged <24 months and to investigate any temporal association between receipt of a rotavirus vaccine and intussusception. A retrospective chart review of all patients diagnosed with intussusception at Royal Children's Hospital, Melbourne, Australia over an 8-year period including before and after rotavirus vaccine introduction into the National Immunisation Program, was conducted using patients identified by a medical record database (ICD-10-CM 56.1). Patient profile, clinical presentation, treatment and outcome were analysed along with records of immunisation status obtained using the Australian Childhood Immunisation Register. A 9% misclassification rate of discharge diagnosis of intussusception was identified on critical chart review. The incidence rate of intussusception at the Royal Children's Hospital over the study period was 1.91 per 10,000 infants <24 months (95% CI 1.65-2.20). Intestinal resection was required in 6.5% of infants (95% CI 3.6%, 11.0%). Intussusception occurred within 30 days after vaccination in 2 of 27 patients who had received at least 1 dose of a rotavirus vaccine. Valuable data on the incidence, clinical presentation and treatment outcomes of intussusception can be obtained from data retrieved from hospital medical records in a sentinel paediatric hospital using standardised methodology. However

  8. The Establishment of the Colombian Integrated Program for Antimicrobial Resistance Surveillance (COIPARS): A Pilot Project on Poultry Farms, Slaughterhouses and Retail Market.

    PubMed

    Donado-Godoy, P; Castellanos, R; León, M; Arevalo, A; Clavijo, V; Bernal, J; León, D; Tafur, M A; Byrne, B A; Smith, W A; Perez-Gutierrez, E

    2015-04-01

    The development of antimicrobial resistance among bacteria (AMR) is currently one of the world's most pressing public health problems. The use of antimicrobial agents in humans and animals has resulted in AMR which has narrowed the potential use of antibiotics for the treatment of infections in humans. To monitor AMR and to develop control measures, some countries, such as the USA, Canada and Denmark, have established national integrated surveillance systems (FDA, , CIPARS, 2007, DANMAP,2002). The components of these programs monitor changes in susceptibility/resistance to antimicrobial agents of selected zoonotic pathogens and commensal organisms recovered from animals, retail meats and humans. The rapid development of Colombia's animal production industry has raised food safety issues including the emergence of antibiotic resistance. The Colombian Integrated Surveillance Program for Antimicrobial Resistance (COIPARS) was established as a pilot project to monitor AMR on poultry farms, slaughter houses and retail markets.

  9. 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.

  10. Exploring the Benefits of Molecular Testing for Gonorrhoea Antibiotic Resistance Surveillance in Remote Settings.

    PubMed

    Hui, Ben B; Ryder, Nathan; Su, Jiunn-Yih; Ward, James; Chen, Marcus Y; Donovan, Basil; Fairley, Christopher K; Guy, Rebecca J; Lahra, Monica M; Law, Mathew G; Whiley, David M; Regan, David G

    2015-01-01

    Surveillance for gonorrhoea antimicrobial resistance (AMR) is compromised by a move away from culture-based testing in favour of more convenient nucleic acid amplification test (NAAT) tests. We assessed the potential benefit of a molecular resistance test in terms of the timeliness of detection of gonorrhoea AMR. An individual-based mathematical model was developed to describe the transmission of gonorrhoea in a remote Indigenous population in Australia. We estimated the impact of the molecular test on the time delay between first importation and the first confirmation that the prevalence of gonorrhoea AMR (resistance proportion) has breached the WHO-recommended 5% threshold (when a change in antibiotic should occur). In the remote setting evaluated in this study, the model predicts that when culture is the only available means of testing for AMR, the breach will only be detected when the actual prevalence of AMR in the population has already reached 8 - 18%, with an associated delay of ~43 - 69 months between first importation and detection. With the addition of a molecular resistance test, the number of samples for which AMR can be determined increases facilitating earlier detection at a lower resistance proportion. For the best case scenario, where AMR can be determined for all diagnostic samples, the alert would be triggered at least 8 months earlier than using culture alone and the resistance proportion will have only slightly exceeded the 5% notification threshold. Molecular tests have the potential to provide more timely warning of the emergence of gonorrhoea AMR. This in turn will facilitate earlier treatment switching and more targeted treatment, which has the potential to reduce the population impact of gonorrhoea AMR.

  11. 76 FR 71087 - Market Test of Experimental Product: “First-Class Tracer”

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-16

    ... From the Federal Register Online via the Government Publishing Office POSTAL SERVICE Market Test...: The Postal Service gives notice of a market test of an experimental product in accordance with... 39 U.S.C. 3641(c)(1) that it will begin a market test of its ``First-Class Tracer'' experimental...

  12. 77 FR 64366 - Market Test of Experimental Product-Metro Post

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-19

    ... From the Federal Register Online via the Government Publishing Office POSTAL SERVICE Market Test... Service gives notice of a market test of an experimental product in accordance with statutory requirements... 39 U.S.C. 3641(c)(1), it will begin a market test of its Metro Post experimental product on or after...

  13. 75 FR 16874 - Market Test of “Samples Co-Op Box” Experimental Product

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-02

    ... From the Federal Register Online via the Government Publishing Office POSTAL SERVICE Market Test...: The Postal Service gives notice of a market test of an experimental product in accordance with...) that it will begin a market test of its ``Samples Co-Op Box'' experimental product on May 1, 2010. The...

  14. 77 FR 64566 - Market Test of Experimental Product-Metro Post

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-22

    ... Market Test of Experimental Product--Metro Post AGENCY: Postal Regulatory Commission. ACTION: Notice. SUMMARY: The Commission is noticing a recently-filed Postal Service proposal to conduct a market test... market test of an experimental product called Metro ] Post.\\1\\ Metro Post is a package delivery service...

  15. 76 FR 2930 - Market Test of Experimental Product: “Gift Cards”

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-18

    ... From the Federal Register Online via the Government Publishing Office POSTAL SERVICE Market Test... Postal Service gives notice of a market test of an experimental product in accordance with statutory...) that it will begin a market test of its ``Gift Cards'' experimental product on or around May 1, 2011...

  16. [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

  17. 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

  18. 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.

  19. 77 FR 32633 - Approval of Test Marketing Exemptions for Certain New Chemicals

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-01

    ... AGENCY Approval of Test Marketing Exemptions for Certain New Chemicals AGENCY: Environmental Protection... marketing exemptions (TMEs) under section 5(h)(1) of the Toxic Substances Control Act (TSCA). EPA has...-7. The test marketing conditions are described in the TME applications and in this notice. DATES...

  20. 75 FR 77634 - Approval of Test Marketing Exemptions for Certain New Chemicals

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-13

    ... AGENCY Approval of Test Marketing Exemptions for Certain New Chemicals AGENCY: Environmental Protection... marketing exemptions (TMEs) under section 5(h)(1) of the Toxic Substances Control Act (TSCA) and 40 CFR 720...; TME-10-06; TME-10-08; TME-10-09. The test marketing conditions are described in the TME applications...

  1. Postmarketing surveillance.

    PubMed

    Vlahović-Palčevski, Vera; Mentzer, Dirk

    2011-01-01

    Postmarketing drug surveillance refers to the monitoring of drugs once they reach the market after clinical trials. It evaluates drugs taken by individuals under a wide range of circumstances over an extended period of time. Such surveillance is much more likely to detect previously unrecognized positive or negative effects that may be associated with a drug. The majority of postmarketing surveillance concern adverse drug reactions (ADRs) monitoring and evaluation. Other important postmarketing surveillance components include unapproved or off-label drug use, problems with orphan drugs, and lack of paediatric formulations, as well as issues concerning international clinical trials in paediatric population. The process of evaluating and improving the safety of medicines used in paediatric practice is referred to as paediatric pharmacovigilance. It requires special attention. Childhood diseases and disorders may be qualitatively and quantitatively different from their adult equivalents. This may affect either benefit or risk of therapies (or both), with a resulting impact on the risk/benefit balance. In addition, chronic conditions may require chronic treatment and susceptibility to ADRs may change throughout the patient's lifetime according to age and stage of growth and development. Therefore, paediatric pharmacovigillance aspects need to be tailored to a number of variables based on heterogeneity of paediatric population. This chapter will summarize and discuss the key issues.

  2. Improving the space surveillance telescope's performance using multi-hypothesis testing

    SciTech Connect

    Chris Zingarelli, J.; Cain, Stephen; Pearce, Eric; Lambour, Richard; Blake, Travis; Peterson, Curtis J. R.

    2014-05-01

    The Space Surveillance Telescope (SST) is a Defense Advanced Research Projects Agency program designed to detect objects in space like near Earth asteroids and space debris in the geosynchronous Earth orbit (GEO) belt. Binary hypothesis test (BHT) methods have historically been used to facilitate the detection of new objects in space. In this paper a multi-hypothesis detection strategy is introduced to improve the detection performance of SST. In this context, the multi-hypothesis testing (MHT) determines if an unresolvable point source is in either the center, a corner, or a side of a pixel in contrast to BHT, which only tests whether an object is in the pixel or not. The images recorded by SST are undersampled such as to cause aliasing, which degrades the performance of traditional detection schemes. The equations for the MHT are derived in terms of signal-to-noise ratio (S/N), which is computed by subtracting the background light level around the pixel being tested and dividing by the standard deviation of the noise. A new method for determining the local noise statistics that rejects outliers is introduced in combination with the MHT. An experiment using observations of a known GEO satellite are used to demonstrate the improved detection performance of the new algorithm over algorithms previously reported in the literature. The results show a significant improvement in the probability of detection by as much as 50% over existing algorithms. In addition to detection, the S/N results prove to be linearly related to the least-squares estimates of point source irradiance, thus improving photometric accuracy.

  3. Improving the Space Surveillance Telescope's Performance Using Multi-Hypothesis Testing

    NASA Astrophysics Data System (ADS)

    Zingarelli, J. Chris; Pearce, Eric; Lambour, Richard; Blake, Travis; Peterson, Curtis J. R.; Cain, Stephen

    2014-05-01

    The Space Surveillance Telescope (SST) is a Defense Advanced Research Projects Agency program designed to detect objects in space like near Earth asteroids and space debris in the geosynchronous Earth orbit (GEO) belt. Binary hypothesis test (BHT) methods have historically been used to facilitate the detection of new objects in space. In this paper a multi-hypothesis detection strategy is introduced to improve the detection performance of SST. In this context, the multi-hypothesis testing (MHT) determines if an unresolvable point source is in either the center, a corner, or a side of a pixel in contrast to BHT, which only tests whether an object is in the pixel or not. The images recorded by SST are undersampled such as to cause aliasing, which degrades the performance of traditional detection schemes. The equations for the MHT are derived in terms of signal-to-noise ratio (S/N), which is computed by subtracting the background light level around the pixel being tested and dividing by the standard deviation of the noise. A new method for determining the local noise statistics that rejects outliers is introduced in combination with the MHT. An experiment using observations of a known GEO satellite are used to demonstrate the improved detection performance of the new algorithm over algorithms previously reported in the literature. The results show a significant improvement in the probability of detection by as much as 50% over existing algorithms. In addition to detection, the S/N results prove to be linearly related to the least-squares estimates of point source irradiance, thus improving photometric accuracy. The views expressed are those of the author and do not reflect the official policy or position of the Department of Defense or the U.S. Government.

  4. [Post-marketing surveillance of acetylcysteine oral solution 17.6% "SENJU" for the antidote to acetaminophen overdose--use--results surveillance].

    PubMed

    Suenobu, Toshihide; Yoshioka, Toshiharu; Maruta, Shinichi; Shimoji, Hidemi

    2006-10-01

    Use-result surveillance was conducted to investigate the safety and efficacy of Acetylcysteine Oral Solution 17.6 % "SENJU" having the indication for the antidote to acetaminophen (Paracetamol) overdose. Ninety six cases (patients) were collected for the safety evaluation, and 13 cases (incidence was 13.5 %) showed 29 adverse drug reactions as follows: 4 cases of nausea; 3 cases of vomiting; 2 cases each of liver dysfunction, headache, abdominal pain, diarrhea, blood bilirubin increased; and one case each of CK increased, anaemia, prothrombin time prolonged, gamma-glutamyltransferase increased, LDH increased, body temperature increased, proteinuria, blood potassium decreased, thrombocytopenia, platelet count increased, white blood cell decreased, and blood amylase increased. One case of severe liver dysfunction which was ameliorated later was found. Neither case showing transitional chronic liver dysfunction, nor case of death was observed. Patient background analysis showed that 79.2% of the total patients was female, and that 28.1% was patients with mental disease. Gastrolavage, active charcoal administration, and extracorporeal removal of toxins were performed in cases of 71.9%, 50.0% and 7.3%, respectively. Those concomitant treatments, however, showed no influence for the incidence of adverse drug reaction or the drug effectiveness. Blood acetaminophen assay was performed in only 43.8% of the total cases. This rate indicates that the medical treatment procedure needs more consideration on the clinical standard for the antidote to acetaminophen overdose and on its practical application.

  5. Psychological testing and the German labor market, 1925 to 1965.

    PubMed

    Meskill, David

    2015-11-01

    From the 1920s to the 1950s, the massive German Labor Administration used loosely standardized, pragmatic evaluations of personality to steer young people into appropriate jobs. Starting in the late 1950s, the Administration shifted to American scientific methods of trait and factor psychological testing. Behind this change lay not a change in academic psychology but a power shift in the German labor market. Originally, the Labor Administration had to appeal to employers, for whom pragmatic evaluations of personality seemed most convincing. Thanks to the Economic Miracle in the 1950s, the Administration had to gain the trust of young Germans, their parents, and the public, who, it was hoped, would be won over by science.

  6. Matrix market: a web resource for test matrix collection

    SciTech Connect

    Boisvert, R.F.; Pozo, R.; Remington, K.; Barrett, R.F.; Dongarra, J.J. /

    1996-05-30

    We describe a repository of data for the testing of numerical algorithms and mathematical software for matrix computations. The repository is designed to accommodate both dense and sparse matrices, as well as software to generate matrices. It has been seeded with the well known Harwell-Boeing sparse matrix collection. The raw data files have been augmented with an integrated World Wide Web interface which describes the matrices in the collection quantitatively and visually, For example, each matrix has a Web page which details its attributes, graphically depicts its sparsity pattern, and provides access to the matrix itself in several formats. In addition, a search mechanism is included which allows retrieval of matrices based on a variety of attributes, such as type and size, as well as through free-text search in abstracts. The URL is http://math.nist.gov/MatrixMarket.

  7. Surveillance and Testing for Middle East Respiratory Syndrome Coronavirus, Saudi Arabia, April 2015–February 2016

    PubMed Central

    Bin Saeed, Abdulaziz A.; Alzahrani, Abdullah G.; Salameh, Iyad; Abdirizak, Fatima; Alhakeem, Raafat; Algarni, Homoud; El Nil, Osman A.; Mohammed, Mutaz; Assiri, Abdullah M.; Alabdely, Hail M.; Watson, John T.; Gerber, Susan I.

    2017-01-01

    Saudi Arabia has reported >80% of the Middle East respiratory syndrome coronavirus (MERS-CoV) cases worldwide. During April 2015–February 2016, Saudi Arabia identified and tested 57,363 persons (18.4/10,000 residents) with suspected MERS-CoV infection; 384 (0.7%) tested positive. Robust, extensive, and timely surveillance is critical for limiting virus transmission. PMID:28322710

  8. Contraceptive social marketing: a continuous cycle of planning, testing and evaluating.

    PubMed

    1985-01-01

    This article outlines the contraceptive marketing process used by the Social Marketing for Change (SOMARC) project. The 1st stage of the process involves analysis of the market, the consumer, and the social marketing organization's capabilities. In the 2nd stage, planning, data collected in the analysis stage are used to define objectives, segment target markets, and devise strategies for each element in the marketing mix. In the 3rd stage, all the elements in the marketing mix are developed and tested (e.g. product concepts, pricing, packaging, communication messages) and refined on the basis of test results. In stage 4, the action plan is implemented and marketing progress and institutional performance are monitored. Stage 5 includes an assessment of in-market effectiveness in terms of responses from consumers, retailers, and health professionals. The last stage feeds back to the 1st. All the reviewed data are recycled into analysis to begin again the continuous process of refinement and improvement.

  9. Specific antigen serologic tests in leprosy: implications for epidemiological surveillance of leprosy cases and household contacts

    PubMed Central

    Carvalho, Ana Paula Mendes; Coelho, Angélica da Conceição Oliveira; Correa-Oliveira, Rodrigo; Lana, Francisco Carlos Félix

    2017-01-01

    BACKGROUND There is a lack of straightforward tests for field application and known biomarkers for predicting leprosy progression in infected individuals. OBJECTIVE The aim was to analyse the response to infection by Mycobacterium leprae based on the reactivity of specific antigens: natural disaccharide linked to human serum albumin via an octyl (NDOHSA), a semisynthetic phenolic glycolipid-I (PGL-I); Leprosy Infectious Disease Research Institute Diagnostic-1 (LID-1) and natural disaccharide octyl - Leprosy Infectious Disease Research Institute Diagnostic-1 (NDOLID). METHODS The study population consisted of 130 leprosy cases diagnosed between 2010 and 2015 and 277 household contacts. An enzyme-linked immunosorbent assay (ELISA) was used to analyse the reactivity of antibodies against NDOHSA, LID-1 and NDOLID. The samples and controls were tested in duplicate, and the antibody titer was expressed as an ELISA index. Data collection was made by home visits with application of questionnaire and dermatological evaluation of all household contacts to identify signs and symptoms of leprosy. FINDINGS Significant differences in the median ELISA results were observed among leprosy cases in treatment, leprosy cases that had completed treatment and household contacts. Higher proportions of seropositivity were observed in leprosy cases in treatment. Seropositivity was also higher in multibacillary in relation to paucibacillary, with the difference reaching statistical significance. Lower titers were observed among cases with a longer treatment time or discharge. For household contacts, the differences according to the clinical characteristics of the leprosy index case were less pronounced than expected. Other factors, such as the endemicity of leprosy, exposure outside the residence and genetic characteristics, appeared to have a greater influence on the seropositivity. MAIN CONCLUSIONS Serologic tests could be used as auxiliary tools for determining the operational

  10. External quality assurance of malaria nucleic acid testing for clinical trials and eradication surveillance.

    PubMed

    Murphy, Sean C; Hermsen, Cornelus C; Douglas, Alexander D; Edwards, Nick J; Petersen, Ines; Fahle, Gary A; Adams, Matthew; Berry, Andrea A; Billman, Zachary P; Gilbert, Sarah C; Laurens, Matthew B; Leroy, Odile; Lyke, Kristen E; Plowe, Christopher V; Seilie, Annette M; Strauss, Kathleen A; Teelen, Karina; Hill, Adrian V S; Sauerwein, Robert W

    2014-01-01

    Nucleic acid testing (NAT) for malaria parasites is an increasingly recommended diagnostic endpoint in clinical trials of vaccine and drug candidates and is also important in surveillance of malaria control and elimination efforts. A variety of reported NAT assays have been described, yet no formal external quality assurance (EQA) program provides validation for the assays in use. Here, we report results of an EQA exercise for malaria NAT assays. Among five centers conducting controlled human malaria infection trials, all centers achieved 100% specificity and demonstrated limits of detection consistent with each laboratory's pre-stated expectations. Quantitative bias of reported results compared to expected results was generally <0.5 log10 parasites/mL except for one laboratory where the EQA effort identified likely reasons for a general quantitative shift. The within-laboratory variation for all assays was low at <10% coefficient of variation across a range of parasite densities. Based on this study, we propose to create a Molecular Malaria Quality Assessment program that fulfills the need for EQA of malaria NAT assays worldwide.

  11. GPS-Squitter Automatic Dependent Surveillance Broadcast: Flight Testing in the Gulf of Mexico,

    DTIC Science & Technology

    1995-10-13

    serviced by oil platform helicopters. The report concludes that GPS- Squitter is a near-term option for providing accurate, real-time surveillance of aircraft operating in the offshore airspace in the Gulf of Mexico .... of Mexico . Three squitter ground stations were located in the vicinity of Morgan City, Louisiana, for this evaluation: two were located on offshore...During November - December 1994, MIT Lincoln Laboratory conducted a field evaluation of the air surveillance capabilities of GPS-Squitter in the Gulf

  12. Surveillance of compliance with tobacco regulations in Örebro County, Sweden: a mixed methods study after the ban of test purchases

    PubMed Central

    2012-01-01

    Background Tobacco has long been known to be one of the most common reasons for sickness and premature deaths in the world. An important aspect of tobacco use is the youth's access to tobacco, and surveillance visits are one way to make sure how retailers are complying with age limit in the tobacco law. In Örebro County, Sweden, a project to reinforce the tobacco legislation was carried out in 2009-2010. One part of the project was surveillance visits that were done according to three different themes, called thematic surveillance. Methods This study is an evaluation of the results from thematic surveillance and has a mixed methods approach. The quantitative analyses concerns protocols from 217 surveillance visits, where questions were asked about three themes (self-monitoring programs; marketing; labeling of products and pricing). In addition, questionnaires filled out by six tobacco administrators who worked within the project were analyzed qualitatively by content analysis in order to study their perceptions and opinions of the project. Results This study shows that half of the visited retailers had self-monitoring programs. Lack of self-monitoring programs was significantly more common in smaller stores/kiosks and at restaurants. Further, the tobacco administrators who worked within the project perceived thematic surveillance as a good method for accomplishing better structure in surveillance work, but not as effective as purchase attempts (mystery shopping). Conclusions Thematic surveillance was perceived as positive and the method was also regarded to be a good way to work with surveillance. However, the method could be developed further for optimal use and better effect at the retailers. It is clear that people who work with tobacco prevention at the local level in Örebro County want to use purchase attempts as a surveillance method, and that they believe that purchase attempts is the best way to make sure if store comply with the tobacco law. PMID

  13. Surveillance of compliance with tobacco regulations in Örebro County, Sweden: a mixed methods study after the ban of test purchases.

    PubMed

    Schölin, Lisa; Eriksson, Charli

    2012-02-15

    Tobacco has long been known to be one of the most common reasons for sickness and premature deaths in the world. An important aspect of tobacco use is the youth's access to tobacco, and surveillance visits are one way to make sure how retailers are complying with age limit in the tobacco law. In Örebro County, Sweden, a project to reinforce the tobacco legislation was carried out in 2009-2010. One part of the project was surveillance visits that were done according to three different themes, called thematic surveillance. This study is an evaluation of the results from thematic surveillance and has a mixed methods approach. The quantitative analyses concerns protocols from 217 surveillance visits, where questions were asked about three themes (self-monitoring programs; marketing; labeling of products and pricing). In addition, questionnaires filled out by six tobacco administrators who worked within the project were analyzed qualitatively by content analysis in order to study their perceptions and opinions of the project. This study shows that half of the visited retailers had self-monitoring programs. Lack of self-monitoring programs was significantly more common in smaller stores/kiosks and at restaurants. Further, the tobacco administrators who worked within the project perceived thematic surveillance as a good method for accomplishing better structure in surveillance work, but not as effective as purchase attempts (mystery shopping). Thematic surveillance was perceived as positive and the method was also regarded to be a good way to work with surveillance. However, the method could be developed further for optimal use and better effect at the retailers. It is clear that people who work with tobacco prevention at the local level in Örebro County want to use purchase attempts as a surveillance method, and that they believe that purchase attempts is the best way to make sure if store comply with the tobacco law.

  14. Interactions between domestic and export markets for softwood lumber and plywood: tests of six hypotheses.

    Treesearch

    David R. Darr

    1981-01-01

    Price formation in export markets and available data on export and domestic markets are discussed. The results of tests of several hypotheses about interactions between domestic and export markets are presented and interpreted from the standpoints of trade promotion and trade policy.

  15. Appropriateness of endoscopic surveillance recommendations in organised colorectal cancer screening programmes based on the faecal immunochemical test.

    PubMed

    Zorzi, Manuel; Senore, Carlo; Turrin, Anna; Mantellini, Paola; Visioli, Carmen Beatriz; Naldoni, Carlo; Sassoli De' Bianchi, Priscilla; Fedato, Chiara; Anghinoni, Emanuela; Zappa, Marco; Hassan, Cesare

    2016-11-01

    To assess the appropriateness of recommendations for endoscopic surveillance in organised colorectal cancer (CRC) screening programmes based on the faecal immunochemical test (FIT). 74 Italian CRC screening programmes provided aggregated data on the recommendations given after FIT-positive colonoscopies in 2011 and 2013. Index colonoscopies were divided into negative/no adenoma and low- risk, intermediate-risk and high-risk adenomas. Postcolonoscopy recommendations included a return to screening (FIT after 2 years or 5 years), an endoscopic surveillance after 6 months or after 1 year, 3 years or 5 years, surgery or other. We assessed the deviation from the postcolonoscopy recommendations of the European Guidelines in 2011 and 2013 and the correlation between overuse of endoscopic surveillance in 2011 and the process indicators associated with the endoscopic workload in 2013. 49 704 postcolonoscopy recommendations were analysed. High-risk, intermediate-risk and low-risk adenomas, and no adenomas were reported in 5.9%, 19.3%, 15.3% and 51.5% of the cases, respectively. Endoscopic surveillance was inappropriately recommended in 67.4% and 7%, respectively, of cases with low-risk and no adenoma. Overall, 37% of all endoscopic surveillance recommendations were inappropriate (6696/17 860). Overuse of endoscopic surveillance was positively correlated with the extension of invitations (correlation coefficient (cc) 0.29; p value 0.03) and with compliance with post-FIT+ colonoscopy (cc 0.25; p value 0.05), while it was negatively correlated with total colonoscopy waiting times longer than 60 days (cc -0.26; p value 0.05). In organised screening programmes, a high rate of inappropriate recommendations for patients with low risk or no adenomas occurs, affecting the demand for endoscopic surveillance by a third. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  16. 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.

  17. Live bird markets characterization and trading network analysis in Mali: Implications for the surveillance and control of avian influenza and Newcastle disease.

    PubMed

    Molia, Sophie; Boly, Ismaël Ardho; Duboz, Raphaël; Coulibaly, Boubacar; Guitian, Javier; Grosbois, Vladimir; Fournié, Guillaume; Pfeiffer, Dirk Udo

    2016-03-01

    Live bird markets (LBMs) play an important role in the transmission of avian influenza (AI) and Newcastle disease (ND) viruses in poultry. Our study had two objectives: (1) characterizing LBMs in Mali with a focus on practices influencing the risk of transmission of AI and ND, and (2) identifying which LBMs should be targeted for surveillance and control based on properties of the live poultry trade network. Two surveys were conducted in 2009-2010: a descriptive study in all 96 LBMs of an area encompassing approximately 98% of the Malian poultry population and a network analysis study in Sikasso county, the main poultry supplying county for the capital city Bamako. Regarding LBMs' characteristics, risk factors for the presence of AI and ND viruses (being open every day, more than 2 days before a bird is sold, absence of zoning to segregate poultry-related work flow areas, waste removal or cleaning and disinfecting less frequently than on a daily basis, trash disposal of dead birds and absence of manure processing) were present in 80-100% of the LBMs. Furthermore, LBMs tended to have wide catchment areas because of consumers' preference for village poultry meat, thereby involving a large number of villages in their supply chain. In the poultry trade network from/to Sikasso county, 182 traders were involved and 685 links were recorded among 159 locations. The network had a heterogeneous degree distribution and four hubs were identified based on measures of in-degrees, out-degrees and betweenness: the markets of Medine and Wayerma and the fairs of Farakala and Niena. These results can be used to design biosecurity-improvement interventions and to optimize the prevention, surveillance and control of transmissible poultry diseases in Malian LBMs. Further studies should investigate potential drivers (seasonality, prices) of the poultry trade network and the acceptability of biosecurity and behavior-change recommendations in the Malian socio-cultural context.

  18. The national market for Medicare clinical laboratory testing: implications for payment reform.

    PubMed

    Gass Kandilov, Amy M; Pope, Gregory C; Kautter, John; Healy, Deborah

    2012-01-01

    Current Medicare payment policy for outpatient laboratory services is outdated. Future reforms, such as competitive bidding, should consider the characteristics of the laboratory market. To inform payment policy, we analyzed the structure of the national market for Medicare Part B clinical laboratory testing, using a 5-percent sample of 2006 Medicare claims data. The independent laboratory market is dominated by two firms--Quest Diagnostics and Laboratory Corporation of America. The hospital outreach market is not as concentrated as the independent laboratory market. Two subgroups of Medicare beneficiaries, those with end-stage renal disease and those residing in nursing homes, are each served in separate laboratory markets. Despite the concentrated independent laboratory market structure, national competitive bidding for non-patient laboratory tests could result in cost savings for Medicare.

  19. Feasibility of utilizing the SD BIOLINE Onchocerciasis IgG4 rapid test in onchocerciasis surveillance in Senegal.

    PubMed

    Dieye, Yakou; Storey, Helen L; Barrett, Kelsey L; Gerth-Guyette, Emily; Di Giorgio, Laura; Golden, Allison; Faulx, Dunia; Kalnoky, Michael; Ndiaye, Marie Khemesse Ngom; Sy, Ngayo; Mané, Malang; Faye, Babacar; Sarr, Mamadou; Dioukhane, Elhadji Mamadou; Peck, Roger B; Guinot, Philippe; de Los Santos, Tala

    2017-10-03

    As effective onchocerciasis control efforts in Africa transition to elimination efforts, different diagnostic tools are required to support country programs. Senegal, with its long standing, successful control program, is transitioning to using the SD BIOLINE Onchocerciasis IgG4 (Ov16) rapid test over traditional skin snip microscopy. The aim of this study is to demonstrate the feasibility of integrating the Ov16 rapid test into onchocerciasis surveillance activities in Senegal, based on the following attributes of acceptability, usability, and cost. A cross-sectional study was conducted in 13 villages in southeastern Senegal in May 2016. Individuals 5 years and older were invited to participate in a demographic questionnaire, an Ov16 rapid test, a skin snip biopsy, and an acceptability interview. Rapid test technicians were interviewed and a costing analysis was conducted. Of 1,173 participants, 1,169 (99.7%) agreed to the rapid test while 383 (32.7%) agreed to skin snip microscopy. The sero-positivity rate of the rapid test among those tested was 2.6% with zero positives 10 years and younger. None of the 383 skin snips were positive for Ov microfilaria. Community members appreciated that the rapid test was performed quickly, was not painful, and provided reliable results. The total costs for this surveillance activity was $22,272.83, with a cost per test conducted at $3.14 for rapid test, $7.58 for skin snip microscopy, and $13.43 for shared costs. If no participants had refused skin snip microscopy, the total cost per method with shared costs would have been around $16 per person tested. In this area with low onchocerciasis sero-positivity, there was high acceptability and perceived value of the rapid test by community members and technicians. This study provides evidence of the feasibility of implementing the Ov16 rapid test in Senegal and may be informative to other country programs transitioning to Ov16 serologic tools.

  20. 78 FR 41129 - Market Test of Experimental Product - International Merchandise Return Service-Non-Published Rates

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-09

    ... will begin a market test of its International Merchandise Return Service (IMRS) Non-published Rate (NPR... From the Federal Register Online via the Government Publishing Office POSTAL SERVICE Market Test of Experimental Product -- International Merchandise Return Service--Non-Published Rates AGENCY: U.S...

  1. 75 FR 67093 - Iceberg Water Deviating From Identity Standard; Temporary Permit for Market Testing

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-01

    ... HUMAN SERVICES Food and Drug Administration Iceberg Water Deviating From Identity Standard; Temporary Permit for Market Testing AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food... Corp., to market test a product designated as ``GLACE Rare Iceberg Water'' that deviates from the U.S...

  2. Testing the performance of technical trading rules in the Chinese markets based on superior predictive test

    NASA Astrophysics Data System (ADS)

    Wang, Shan; Jiang, Zhi-Qiang; Li, Sai-Ping; Zhou, Wei-Xing

    2015-12-01

    Technical trading rules have a long history of being used by practitioners in financial markets. The profitable ability and efficiency of technical trading rules are yet controversial. In this paper, we test the performance of more than seven thousand traditional technical trading rules on the Shanghai Securities Composite Index (SSCI) from May 21, 1992 through June 30, 2013 and China Securities Index 300 (CSI 300) from April 8, 2005 through June 30, 2013 to check whether an effective trading strategy could be found by using the performance measurements based on the return and Sharpe ratio. To correct for the influence of the data-snooping effect, we adopt the Superior Predictive Ability test to evaluate if there exists a trading rule that can significantly outperform the benchmark. The result shows that for SSCI, technical trading rules offer significant profitability, while for CSI 300, this ability is lost. We further partition the SSCI into two sub-series and find that the efficiency of technical trading in sub-series, which have exactly the same spanning period as that of CSI 300, is severely weakened. By testing the trading rules on both indexes with a five-year moving window, we find that during the financial bubble from 2005 to 2007, the effectiveness of technical trading rules is greatly improved. This is consistent with the predictive ability of technical trading rules which appears when the market is less efficient.

  3. Medical Surveillance Programs for Aircraft Maintenance Personnel Performing Nondestructive Inspection and Testing

    DTIC Science & Technology

    2005-11-01

    University Columbus, OH 43210 November 2005 Final Report DOT/ FAA /AM-05/21 Offi ce of Aerospace Medicine Washington, DC 20591 NOTICE This document is...No. DOT/ FAA /AM-05/21 4. Title and Subtitle 5. Report Date November 2005 6. Performing Organization Code Medical Surveillance Programs for...operating condition. A recent FAA report, entitled “Analysis of Airworthiness Directives 1995 to 1999,” indicated that 57% of all Airworthiness

  4. SSTS (Space Surveillance and Tracking System): The Importance of Early Test and Evaluation Organizational Participation

    DTIC Science & Technology

    1988-04-01

    Engineering. At present, all but his dissertation is complete. In 1984, he was assigned to Arnold Engineering Development Center ( AEDC ) in Tennessee. His...AEDC’s aeromechanics technology programs. His final position at AEDC was Chief, Reentry Systems Division where he was responsible for directing...SDI. (3:3-1) Before SDI, this system was known as the Space-Based Surveillance System which was intended to provide support to the antisatellite ( ASAT

  5. A test of syndromic surveillance using a severe acute respiratory syndrome model.

    PubMed

    Wallace, David J; Arquilla, Bonnie; Heffernan, Richard; Kramer, Martin; Anderson, Todd; Bernstein, David; Augenbraun, Michael

    2009-05-01

    We describe a field simulation that was conducted using volunteers to assess the ability of 3 hospitals in a network to manage a large influx of patients with a potentially communicable disease. This drill provided the opportunity to evaluate the ability of the New York City Department of Health and Mental Hygiene's (NYC-DOHMH) emergency department chief complaint syndromic surveillance system to detect a cluster of patients with febrile respiratory illness. The evaluation was a prospective simulation. The clinical picture was modeled on severe acute respiratory syndrome symptoms. Forty-four volunteers participated in the drill as mock patients. Records from 42 patients (95%) were successfully transmitted to the NYC-DOHMH. The electronic chief complaint for 24 (57%) of these patients indicated febrile or respiratory illness. The drill did not generate a statistical signal in the NYC-DOHMH SaTScan analysis. The 42 drill patients were classified in 8 hierarchical categories based on chief complaints: sepsis (2), cold (3), diarrhea (2), respiratory (20), fever/flu (4), vomit (3), and other (8). The number of respiratory visits, while elevated on the day of the drill, did not appear particularly unusual when compared with the 14-day baseline period used for spatial analyses. This drill with a cluster of patients with febrile respiratory illness failed to trigger a signal from the NYC-DOHMH emergency department chief complaint syndromic surveillance system. This highlighted several limitations and challenges to syndromic surveillance monitoring.

  6. 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.

  7. Ground Testing of Prototype Hardware and Processing Algorithms for a Wide Area Space Surveillance System (WASSS)

    NASA Astrophysics Data System (ADS)

    Goldstein, N.; Dressler, R. A.; Richtsmeier, S. S.; McLean, J.; Dao, P. D.; Murray-Krezan, J.; Fulcoly, D. O.

    2013-09-01

    Recent ground testing of a wide area camera system and automated star removal algorithms has demonstrated the potential to detect, quantify, and track deep space objects using small aperture cameras and on-board processors. The camera system, which was originally developed for a space-based Wide Area Space Surveillance System (WASSS), operates in a fixed-stare mode, continuously monitoring a wide swath of space and differentiating celestial objects from satellites based on differential motion across the field of view. It would have greatest utility in a LEO orbit to provide automated and continuous monitoring of deep space with high refresh rates, and with particular emphasis on the GEO belt and GEO transfer space. Continuous monitoring allows a concept of change detection and custody maintenance not possible with existing sensors. The detection approach is equally applicable to Earth-based sensor systems. A distributed system of such sensors, either Earth-based, or space-based, could provide automated, persistent night-time monitoring of all of deep space. The continuous monitoring provides a daily record of the light curves of all GEO objects above a certain brightness within the field of view. The daily updates of satellite light curves offers a means to identify specific satellites, to note changes in orientation and operational mode, and to queue other SSA assets for higher resolution queries. The data processing approach may also be applied to larger-aperture, higher resolution camera systems to extend the sensitivity towards dimmer objects. In order to demonstrate the utility of the WASSS system and data processing, a ground based field test was conducted in October 2012. We report here the results of the observations made at Magdalena Ridge Observatory using the prototype WASSS camera, which has a 4×60° field-of-view , <0.05° resolution, a 2.8 cm2 aperture, and the ability to view within 4° of the sun. A single camera pointed at the GEO belt provided a

  8. Marketing.

    PubMed

    Chambers, David W

    2010-01-01

    There is not enough marketing of dentistry; but there certainly is too much selling of poor quality service that is being passed off as dentistry. The marketing concept makes the patient and the patients' needs the ultimate criteria of marketing efforts. Myths and good practices for effective marketing that will promote oral health are described under the traditional four "Ps" categories of "product" (best dental care), "place" (availability), "promotion" (advertising and other forms of making patients aware of available services and how to use them), and "price" (the total cost to patients of receiving care).

  9. Testing Neoclassical Competitive Theory in Multilateral Decentralized Markets

    ERIC Educational Resources Information Center

    List, John A.

    2004-01-01

    Walrasian tatonnement has been a fundamental assumption in economics ever since Walras' general equilibrium theory was introduced in 1874. Nearly a century after its introduction, Vernon Smith relaxed the Walrasian tatonnement assumption by showing that neoclassical competitive market theory explains the equilibrating forces in "double-auction"…

  10. Testing Neoclassical Competitive Theory in Multilateral Decentralized Markets

    ERIC Educational Resources Information Center

    List, John A.

    2004-01-01

    Walrasian tatonnement has been a fundamental assumption in economics ever since Walras' general equilibrium theory was introduced in 1874. Nearly a century after its introduction, Vernon Smith relaxed the Walrasian tatonnement assumption by showing that neoclassical competitive market theory explains the equilibrating forces in "double-auction"…

  11. Evaluation of surveillance case definition in the diagnosis of leptospirosis, using the Microscopic Agglutination Test: a validation study.

    PubMed

    Dassanayake, Dinesh L B; Wimalaratna, Harith; Agampodi, Suneth B; Liyanapathirana, Veranja C; Piyarathna, Thibbotumunuwe A C L; Goonapienuwala, Bimba L

    2009-04-22

    Leptospirosis is endemic in both urban and rural areas of Sri Lanka and there had been many out breaks in the recent past. This study was aimed at validating the leptospirosis surveillance case definition, using the Microscopic Agglutination Test (MAT). The study population consisted of patients with undiagnosed acute febrile illness who were admitted to the medical wards of the Teaching Hospital Kandy, from 1st July 2007 to 31st July 2008. The subjects were screened to diagnose leptospirosis according to the leptospirosis case definition. MAT was performed on blood samples taken from each patient on the 7th day of fever. Leptospirosis case definition was evaluated in regard to sensitivity, specificity and predictive values, using a MAT titre >or= 1:800 for confirming leptospirosis. A total of 123 patients were initially recruited of which 73 had clinical features compatible with the surveillance case definition. Out of the 73 only 57 had a positive MAT result (true positives) leaving 16 as false positives. Out of the 50 who didn't have clinical features compatible with the case definition 45 had a negative MAT as well (true negatives), therefore 5 were false negatives. Total number of MAT positives was 62 out of 123. According to these results the test sensitivity was 91.94%, specificity 73.77%, positive predictive value and negative predictive values were 78.08% and 90% respectively. Diagnostic accuracy of the test was 82.93%. This study confirms that the surveillance case definition has a very high sensitivity and negative predictive value with an average specificity in diagnosing leptospirosis, based on a MAT titre of >or= 1: 800.

  12. Statistical testing of the association between annual turnover and marketing activities in SMEs using χ2

    NASA Astrophysics Data System (ADS)

    Pater, Liana; Miclea, Şerban; Izvercian, Monica

    2016-06-01

    This paper considers the impact of SMEs' annual turnover upon its marketing activities (in terms of marketing responsibility, strategic planning and budgeting). Empirical results and literature reviews unveil that SMEs managers incline to partake in planned and profitable marketing activities, depending on their turnover's level. Thus, using the collected data form 131 Romanian SMEs managers, we have applied the Chi-Square Test in order to validate or invalidate three research assumptions (hypotheses), created starting from the empirical and literature findings.

  13. Marketing.

    ERIC Educational Resources Information Center

    Appel, David L.

    This booklet suggests ways in which institutions--Catholic schools in particular--can move beyond public relations and advertising to engage in the broader arena of marketing with its focus on consumer satisfaction. The first of the book's three chapters reviews the concept of marketing, providing definitions of key terms, clarification of…

  14. Marketing.

    ERIC Educational Resources Information Center

    Maust, Robert N.

    1985-01-01

    Although college administrators may be committed to the concept and need for institutional marketing, even a well-developed marketing plan may not work if it is not clearly organized to address special needs. This article reviews management fads, how to make jargon operational, organizational dynamics, and monitoring fads. (MSE)

  15. 17 CFR 38.604 - Financial surveillance.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 17 Commodity and Securities Exchanges 1 2014-04-01 2014-04-01 false Financial surveillance. 38.604... MARKETS Financial Integrity of Transactions § 38.604 Financial surveillance. A designated contract market must monitor members' compliance with the designated contract market's minimum financial standards...

  16. Test marketing of new smokeless tobacco products in four U.S. cities

    PubMed Central

    Biener, Lois; Clark, Pamela I.

    2010-01-01

    Introduction This exploratory study was designed to assess the availability, price, and point-of-purchase marketing strategies for new smokeless tobacco products in 4 test market areas. Methods A random sample of 50 gas stations, convenience and food stores, and tobacco shops was selected in each of 4 test market areas. Pairs of observers visited each store, recorded product information, and engaged vendors in conversation about product demand. Results Snus was available in 64% of the stores, but availability and price differed by brand. Point-of-purchase marketing also varied by brand on a variety of dimensions and all brands appeared to be marketed primarily to smokers. Camel Snus was described by store attendants as having the highest demand and was also the most expensive of the observed products. In light of the number of test market cities and intensity of promotion at retail locations, Camel Snus was the most intensively marketed product. Discussion The results appear to reflect differences in marketing strategy by American snus manufacturers. These strategies may help to predict future marketing of snus and other tobacco products and may provide a baseline for later assessments of product acceptance. PMID:19917598

  17. Test marketing of new smokeless tobacco products in four U.S. cities.

    PubMed

    Rogers, John D; Biener, Lois; Clark, Pamela I

    2010-01-01

    This exploratory study was designed to assess the availability, price, and point-of-purchase marketing strategies for new smokeless tobacco products in 4 test market areas. A random sample of 50 gas stations, convenience and food stores, and tobacco shops was selected in each of 4 test market areas. Pairs of observers visited each store, recorded product information, and engaged vendors in conversation about product demand. Snus was available in 64% of the stores, but availability and price differed by brand. Point-of-purchase marketing also varied by brand on a variety of dimensions and all brands appeared to be marketed primarily to smokers. Camel Snus was described by store attendants as having the highest demand and was also the most expensive of the observed products. In light of the number of test market cities and intensity of promotion at retail locations, Camel Snus was the most intensively marketed product. The results appear to reflect differences in marketing strategy by American snus manufacturers. These strategies may help to predict future marketing of snus and other tobacco products and may provide a baseline for later assessments of product acceptance.

  18. 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

  19. 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.

  20. [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.

  1. Risk factors for HIV seropositivity among people consulting for HIV antibody testing: a pilot surveillance study in Quebec.

    PubMed Central

    Alary, M; Castel, J

    1990-01-01

    The surveillance of AIDS (acquired immune deficiency syndrome) through case reporting only reflects the epidemiologic features of HIV (human immunodeficiency virus) transmission a few years earlier and not the prevalence of HIV seropositivity. HIV infection is not a notifiable condition in Quebec. We were asked by the ministère de la Santé et des Services sociaux du Québec to perform a pilot project for the surveillance of HIV seropositivity using a network of sentinel physicians. From May 15, 1988, to Sept. 30, 1989, physicians from four collaborating centres collected data on the serologic status, demographic characteristics and risk factors for 4209 patients who underwent HIV antibody testing. Of the 3899 subjects included in the study 7.9% were HIV positive. Through logistic regression analysis the following variables were found to be significantly associated with HIV seropositivity: presence of HIV-related symptoms (prevalence odds ratio [POR] 36.5), origin from an endemic area (POR 9.1), homosexuality or bisexuality (POR 8.4), intravenous drug use (POR 4.2), male sex (POR 2.8), previous HIV antibody testing (POR 2.5) and previous sexually transmitted disease (POR 1.8). Over the study period we found a large increase in HIV seroprevalence among intravenous drug users (4.2% in 1988 to 19.0% in 1989) (p = 0.02). This increase might reflect a recent change in the epidemiologic pattern of HIV transmission in Quebec. Surveillance of HIV seropositivity through a network of sentinel physicians may be a reasonable alternative to mandatory reporting. PMID:2357678

  2. Genotyping using whole-genome sequencing is a realistic alternative to surveillance based on phenotypic antimicrobial susceptibility testing.

    PubMed

    Zankari, Ea; Hasman, Henrik; Kaas, Rolf Sommer; Seyfarth, Anne Mette; Agersø, Yvonne; Lund, Ole; Larsen, Mette Voldby; Aarestrup, Frank M

    2013-04-01

    Antimicrobial susceptibility testing of bacterial isolates is essential for clinical diagnosis, to detect emerging problems and to guide empirical treatment. Current phenotypic procedures are sometimes associated with mistakes and may require further genetic testing. Whole-genome sequencing (WGS) may soon be within reach even for routine surveillance and clinical diagnostics. The aim of this study was to evaluate WGS as a routine tool for surveillance of antimicrobial resistance compared with current phenotypic procedures. Antimicrobial susceptibility tests were performed on 200 isolates originating from Danish pigs, covering four bacterial species. Genomic DNA was purified from all isolates and sequenced as paired-end reads on the Illumina platform. The web servers ResFinder and MLST (www.genomicepidemiology.org) were used to identify acquired antimicrobial resistance genes and MLST types (where MLST stands for multilocus sequence typing). ResFinder results were compared with phenotypic antimicrobial susceptibility testing results using EUCAST epidemiological cut-off values and MLST types. A total of 3051 different phenotypic tests were performed; 482 led to the categorizing of isolates as resistant and 2569 as susceptible. Seven cases of disagreement between tested and predicted susceptibility were observed, six of which were related to spectinomycin resistance in Escherichia coli. Correlation between MLST type and resistance profiles was only observed in Salmonella Typhimurium, where isolates belonging to sequence type (ST) 34 were more resistant than ST19 isolates. High concordance (99.74%) between phenotypic and predicted antimicrobial susceptibility was observed. Thus, antimicrobial resistance testing based on WGS is an alternative to conventional phenotypic methods.

  3. Comparison of parental report of blood lead testing in children enrolled in Medicaid with Medicaid claims data and blood lead surveillance reports.

    PubMed

    Polivka, Barbara J; Salsberry, Pamela; Casavant, Marcel J; Chaudry, Rosemary V; Bush, Donna C

    2006-02-01

    The purposes of this study were to identify the congruence of blood lead testing based on parental self-reports with Medicaid claims and blood lead surveillance records, and to determine factors associated with agreement between parental reports of blood lead tests and Medicaid claims or blood lead surveillance records. Data were obtained from a cross-sectional mailed survey of a randomly selected sample of parents of children 1-2 years old enrolled in Medicaid (n=532) and from existing Medicaid claims and blood lead surveillance records. Fifty-six percent of survey respondents reported their child had a blood lead test completed. Of these, only 56% could be confirmed with Medicaid claims/blood lead surveillance data. Logistic regression analysis revealed the odds of blood lead testing per parental report confirmed with Medicaid claims/blood lead surveillance data were 2.6 times greater if the child had > or =3 provider visits, 2.5 times greater if parents reported receiving a reminder about blood lead testing, 2.2 times greater if parents reported receiving information about lead poisoning, 1.6 times greater if residing in an urban county, and 1.5 times greater if the child was more than 2 years old. In conclusion, parents are not always aware if their child had a blood lead test. Information and reminders about blood lead testing should be distributed to parents of young children enrolled in Medicaid and frequently reviewed by healthcare providers.

  4. Social marketing's unique contribution to mental health stigma reduction and HIV testing: two case studies.

    PubMed

    Thackeray, Rosemary; Keller, Heidi; Heilbronner, Jennifer Messenger; Dellinger, Laura K Lee

    2011-03-01

    Since its inception in 2005, articles in Health Promotion Practice's social marketing department have focused on describing social marketing's unique contributions and the application of each to the practice of health promotion. This article provides a brief review of six unique features (marketing mix, consumer orientation, segmentation, exchange, competition, and continuous monitoring) and then presents two case studies-one on reducing stigma related to mental health and the other a large-scale campaign focused on increasing HIV testing among African American youth. The two successful case studies show that social marketing principles can be applied to a wide variety of topics among various population groups.

  5. 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

  6. Trading strategy based on dynamic mode decomposition: Tested in Chinese stock market

    NASA Astrophysics Data System (ADS)

    Cui, Ling-xiao; Long, Wen

    2016-11-01

    Dynamic mode decomposition (DMD) is an effective method to capture the intrinsic dynamical modes of complex system. In this work, we adopt DMD method to discover the evolutionary patterns in stock market and apply it to Chinese A-share stock market. We design two strategies based on DMD algorithm. The strategy which considers only timing problem can make reliable profits in a choppy market with no prominent trend while fails to beat the benchmark moving-average strategy in bull market. After considering the spatial information from spatial-temporal coherent structure of DMD modes, we improved the trading strategy remarkably. Then the DMD strategies profitability is quantitatively evaluated by performing SPA test to correct the data-snooping effect. The results further prove that DMD algorithm can model the market patterns well in sideways market.

  7. Comparing Postsecondary Marketing Student Performance on Computer-Based and Handwritten Essay Tests

    ERIC Educational Resources Information Center

    Truell, Allen D.; Alexander, Melody W.; Davis, Rodney E.

    2004-01-01

    The purpose of this study was to determine if there were differences in postsecondary marketing student performance on essay tests based on test format (i.e., computer-based or handwritten). Specifically, the variables of performance, test completion time, and gender were explored for differences based on essay test format. Results of the study…

  8. Efficacy, tolerability and safety of nebivolol in patients with hypertension and diabetes: a post-marketing surveillance study.

    PubMed

    Van Bortel, L M

    2010-09-01

    Hypertension is a widely prevalent condition of elevated blood pressure (BP) and is the leading risk factor for the development of cardiovascular disease (CVD). Many patients have additional risk factors such as diabetes mellitus (DM) or previous history of CVD. Nebivolol is a third-generation beta (beta)-blockers which has been shown not to influence metabolic parameters in patients with DM. This postmarketing surveillance study aimed to collect information on the efficacy, safety and tolerability of nebivolol in hypertensive patients with concomitant DM. Hypertensive patients with DM followed by 52 cardiologists, internal medicine specialists and general practitioners, between 24 August 2003 and 9 January 2007 in The Netherlands were included in this study. Physicians were asked to survey nebivolol treatment for 6 months. A total of 510 patients were enrolled. Overall, 93.3% of patients were diagnosed with essential hypertension and 6.7% with secondary hypertension. All patients were co-diagnosed with DM. Nebivolol therapy was associated with a significant reduction in both systolic blood pressure (BP) and diastolic BP versus baseline (p < 0.001 for both). These reductions were seen regardless of reason for initiation of nebivolol (i.e. first diagnosis of hypertension, resistance or intolerance to previous antihypertensive medication, or other reasons). A significant improvement in blood glucose was seen at 4 months (-0.6 mmol/L; p = 0.021). Significant reductions in total cholesterol (-1.45 mmol/L; p = 0.006), low density lipoprotein (LDL) cholesterol (-1.32 mmol/L; p = 0.003) and LDL/high density lipoprotein (HDL) cholesterol ratio (-0.77; p = 0.011) were observed at 2 months. No significant changes were seen in HDL cholesterol and triglycerides. Nebivolol treatment was associated with a significantly reduced BP, improved blood glucose and LDL cholesterol levels and was well tolerated in hypertensive patients with concomitant DM.

  9. Surveillance of Acute Respiratory Infections Using Community-Submitted Symptoms and Specimens for Molecular Diagnostic Testing

    PubMed Central

    Goff, Jennifer; Rowe, Aaron; Brownstein, John S.; Chunara, Rumi

    2015-01-01

    Participatory systems for surveillance of acute respiratory infection give real-time information about infections circulating in the community, yet to-date are limited to self-reported syndromic information only and lacking methods of linking symptom reports to infection types. We developed the GoViral platform to evaluate whether a cohort of lay volunteers could, and would find it useful to, contribute self-reported symptoms online and to compare specimen types for self-collected diagnostic information of sufficient quality for respiratory infection surveillance. Volunteers were recruited, given a kit (collection materials and customized instructions), instructed to report their symptoms weekly, and when sick with cold or flu-like symptoms, requested to collect specimens (saliva and nasal swab). We compared specimen types for respiratory virus detection sensitivity (via polymerase-chain-reaction) and ease of collection. Participants were surveyed to determine receptivity to participating when sick, to receiving information on the type of pathogen causing their infection and types circulating near them. Between December 1 2013 and March 1 2014, 295 participants enrolled in the study and received a kit. Of those who reported symptoms, half (71) collected and sent specimens for analysis. Participants submitted kits on average 2.30 days (95 CI: 1.65 to 2.96) after symptoms began. We found good concordance between nasal and saliva specimens for multiple pathogens, with few discrepancies. Individuals report that saliva collection is easiest and report that receiving information about what pathogen they, and those near them, have is valued and can shape public health behaviors. Community-submitted specimens can be used for the detection of acute respiratory infection with individuals showing receptivity for participating and interest in a real-time picture of respiratory pathogens near them. PMID:26075141

  10. Surveillance of Acute Respiratory Infections Using Community-Submitted Symptoms and Specimens for Molecular Diagnostic Testing.

    PubMed

    Goff, Jennifer; Rowe, Aaron; Brownstein, John S; Chunara, Rumi

    2015-05-27

    Participatory systems for surveillance of acute respiratory infection give real-time information about infections circulating in the community, yet to-date are limited to self-reported syndromic information only and lacking methods of linking symptom reports to infection types. We developed the GoViral platform to evaluate whether a cohort of lay volunteers could, and would find it useful to, contribute self-reported symptoms online and to compare specimen types for self-collected diagnostic information of sufficient quality for respiratory infection surveillance. Volunteers were recruited, given a kit (collection materials and customized instructions), instructed to report their symptoms weekly, and when sick with cold or flu-like symptoms, requested to collect specimens (saliva and nasal swab). We compared specimen types for respiratory virus detection sensitivity (via polymerase-chain-reaction) and ease of collection. Participants were surveyed to determine receptivity to participating when sick, to receiving information on the type of pathogen causing their infection and types circulating near them. Between December 1 2013 and March 1 2014, 295 participants enrolled in the study and received a kit. Of those who reported symptoms, half (71) collected and sent specimens for analysis. Participants submitted kits on average 2.30 days (95 CI: 1.65 to 2.96) after symptoms began. We found good concordance between nasal and saliva specimens for multiple pathogens, with few discrepancies. Individuals report that saliva collection is easiest and report that receiving information about what pathogen they, and those near them, have is valued and can shape public health behaviors. Community-submitted specimens can be used for the detection of acute respiratory infection with individuals showing receptivity for participating and interest in a real-time picture of respiratory pathogens near them.

  11. Clinimetric quality of the fire fighting simulation test as part of the Dutch fire fighters Workers' Health Surveillance

    PubMed Central

    2010-01-01

    Background Clinimetric data for the fire fighting simulation test (FFST), a new test proposed for the Workers' Health Surveillance (WHS) of Dutch fire fighters, were evaluated. Methods Twenty-one fire fighters took the FFST three times with one and three weeks between testing. Clinimetric quality was determined by means of reliability, agreement and validity. For reliability and agreement, the intraclass correlation coefficient (ICC), and standard error of measurement (SEM), were analysed. For construct validity, the tests from 45 fire fighters were correlated with their own and their supervisors' rated work ability. Results The ICCs were 0.56 and 0.79 at the one-week and three-week test-retest periods, respectively. Testing times ranged from 9 to 17 minutes; the SEMs were 70 s at the one-week and 40 s at the three-week test-retest periods. The construct validity was moderate (-0.47 ≤ r ≤ -0.33; p < 0.05). Conclusions The FFST was reliable with acceptable agreement after three weeks. Construct validity was moderate. We recommend using FFST as a part of the WHS for Dutch fire fighters. It is advised that fire fighters should perform the FFST once as a trial before judging their performance in testing time during the second performance. PMID:20132538

  12. Risk-based surveillance for avian influenza control along poultry market chains in South China: The value of social network analysis.

    PubMed

    Martin, Vincent; Zhou, Xiaoyan; Marshall, Edith; Jia, Beibei; Fusheng, Guo; FrancoDixon, Mary Ann; DeHaan, Nicoline; Pfeiffer, Dirk U; Soares Magalhães, Ricardo J; Gilbert, Marius

    2011-12-01

    Over the past two decades, the poultry sector in China went through a phase of tremendous growth as well as rapid intensification and concentration. Highly pathogenic avian influenza virus (HPAIV) subtype H5N1 was first detected in 1996 in Guangdong province, South China and started spreading throughout Asia in early 2004. Since then, control of the disease in China has relied heavily on wide-scale preventive vaccination combined with movement control, quarantine and stamping out. This strategy has been successful in drastically reducing the number of outbreaks during the past 5years. However, HPAIV H5N1 is still circulating and is regularly isolated in traditional live bird markets (LBMs) where viral infection can persist, which represent a public health hazard for people visiting them. The use of social network analysis in combination with epidemiological surveillance in South China has identified areas where the success of current strategies for HPAI control in the poultry production sector may benefit from better knowledge of poultry trading patterns and the LBM network configuration as well as their capacity for maintaining HPAIV H5N1 infection. We produced a set of LBM network maps and estimated the associated risk of HPAIV H5N1 within LBMs and along poultry market chains, providing new insights into how live poultry trade and infection are intertwined. More specifically, our study provides evidence that several biosecurity factors such as daily cage cleaning, daily cage disinfection or manure processing contribute to a reduction in HPAIV H5N1 presence in LBMs. Of significant importance is that the results of our study also show the association between social network indicators and the presence of HPAIV H5N1 in specific network configurations such as the one represented by the counties of origin of the birds traded in LBMs. This new information could be used to develop more targeted and effective control interventions.

  13. 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.

  14. 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.

  15. Market surveillance on non-halal additives incorporated in surimi based products using polymerase chain reaction (PCR)-southern hybridization analysis

    NASA Astrophysics Data System (ADS)

    Aravindran, S.; Sahilah, A. M.; Aminah, A.

    2014-09-01

    Halal surveillance on halal ingredients incorporated in surimi based products were studied using polymerase chain reaction (PCR)-southern hybridization on chip analysis. The primers used in this technique were targeted on mitochondria DNA (mtDNA) of cytochrome b (cyt b) gene sequence which able to differentiate 7 type (beef, chicken, duck, goat, buffalo, lamb and pork) of species on a single chip. 17 (n = 17*3) different brands of surimi-based product were purchased randomly from Selangor local market in January 2013. Of 17 brands, 3 (n = 3*3) brands were positive for chicken DNA, 1 (n = 1*3) brand was positive for goat DNA, and the remainder 13 brands (n = 13*3) have no DNA species detected. The sensitivity of PCR-southern hybridization primers to detect each meat species was 0.1 ng. In the present study, it is evidence that PCR-Southern Hybridization analysis offered a reliable result due to its highly specific and sensitive properties in detecting non-halal additive such as plasma protein incorporation in surimi-based product.

  16. 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.

  17. 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

  18. 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.

  19. Evaluation of Multiplex-Based Antibody Testing for Use in Large-Scale Surveillance for Yaws: a Comparative Study

    PubMed Central

    Cooley, Gretchen M.; Mitja, Oriol; Goodhew, Brook; Pillay, Allan; Lammie, Patrick J.; Castro, Arnold; Moses, Penias; Chen, Cheng; Ye, Tun; Ballard, Ronald

    2016-01-01

    WHO has targeted yaws for global eradication by 2020. The program goals are to interrupt the transmission in countries where yaws is endemic and to certify countries as yaws free where yaws was endemic in the past. No new rapid plasmin reagin (RPR) seroreactivity in young children is required for certification of elimination at a country level. We sought to evaluate whether antibody responses to specific treponemal antigens measured in a high-throughput multiplex bead array (MBA) assay differentiate past versus current infection and whether a nontreponemal lipoidal antigen test can be incorporated into the MBA. Serum and dried blood spot specimens collected for yaws surveillance projects in Ghana, Vanuatu, and Papua New Guinea (PNG) were run on MBA to measure antibodies against recombinant p17 (rp17) and treponemal membrane protein A (TmpA) treponemal antigens. Results were compared to standard treponemal laboratory (TPPA or TPHA [TPP(H)A]) and quantitative RPR test data. Of 589 specimens, 241 were TPP(H)A+/RPR+, 88 were TPP(H)A+/RPR−, 6 were TPP(H)A−/RPR+, and 254 were negative for both tests. Compared to TPP(H)A, reactive concordance of rp17 was 93.7%, while reactive concordance of TmpA was only 81.9%. TmpA-specific reactivity showed good correlation with RPR titers (R2 = 0.41; P < 0.0001). IgG responses to the lipoidal antigen used in RPR testing (cardiolipin) were not detected in the MBA. Our results suggest that TmpA can be used as a treponemal antigen marker for recent or active infection and potentially replace RPR in a high-throughput multiplex tool for large-scale yaws surveillance. PMID:26962086

  20. 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

  1. Rapid diagnostic tests for molecular surveillance of Plasmodium falciparum malaria -assessment of DNA extraction methods and field applicability.

    PubMed

    Morris, Ulrika; Aydin-Schmidt, Berit; Shakely, Delér; Mårtensson, Andreas; Jörnhagen, Louise; Ali, Abdullah S; Msellem, Mwinyi I; Petzold, Max; Gil, José P; Ferreira, Pedro E; Björkman, Anders

    2013-03-19

    The need for new malaria surveillance tools and strategies is critical, given improved global malaria control and regional elimination efforts. High quality Plasmodium falciparum DNA can reliably be extracted from malaria rapid diagnostic tests (RDTs). Together with highly sensitive molecular assays, wide scale collection of used RDTs may serve as a modern tool for improved malaria case detection and drug resistance surveillance. However, comparative studies of DNA extraction efficiency from RDTs and the field applicability are lacking. The aim of this study was to compare and evaluate different methods of DNA extraction from RDTs and to test the field applicability for the purpose of molecular epidemiological investigations. DNA was extracted from two RDT devices (Paracheck-Pf® and SD Bioline Malaria Pf/Pan®), seeded in vitro with 10-fold dilutions of cultured 3D7 P. falciparum parasites diluted in malaria negative whole blood. The level of P. falciparum detection was determined for each extraction method and RDT device with multiple nested-PCR and real-time PCR assays. The field applicability was tested on 855 paired RDT (Paracheck-Pf) and filter paper (Whatman® 3MM) blood samples (734 RDT negative and 121 RDT positive samples) collected from febrile patients in Zanzibar 2010. RDT positive samples were genotyped at four key single nucleotide polymorphisms (SNPs) in pfmdr1 and pfcrt as well as for pfmdr1 copy number, all associated with anti-malarial drug resistance. The P. falciparum DNA detection limit varied with RDT device and extraction method. Chelex-100 extraction performed best for all extraction matrixes. There was no statistically significant difference in PCR detection rates in DNA extracted from RDTs and filter paper field samples. Similarly there were no significant differences in the PCR success rates and genotyping outcomes for the respective SNPs in the 121 RDT positive samples. The results support RDTs as a valuable source of parasite DNA and

  2. Field application of a combined pig and poultry market chain and risk pathway analysis within the Pacific Islands region as a tool for targeted disease surveillance and biosecurity.

    PubMed

    Brioudes, Aurélie; Gummow, Bruce

    2016-07-01

    Limited resources are one of the major constraints in effective disease monitoring and control in developing countries. This paper examines the pig and poultry market chains of four targeted Pacific Island countries and territories (PICTs): Fiji, Papua New Guinea, Solomon Islands and Vanuatu and combines them with a risk pathway analysis to identify the highest risk areas (risk hotspots) and risky practices and behaviours (risk factors) of animal disease introduction and/or spread, using highly pathogenic avian influenza (HPAI) and foot-and-mouth disease (FMD) as model diseases because of their importance in the region. The results show that combining a market chain analysis with risk pathways is a practical way of communicating risk to animal health officials and improving biosecurity. It provides a participatory approach that helps officials to better understand the trading regulations in place in their country and to better evaluate their role as part of the control system. Common risk patterns were found to play a role in all four PICTs. Legal trade pathways rely essentially on preventive measures put in place in the exporting countries while no or only limited control measures are undertaken by the importing countries. Legal importations of animals and animal products are done mainly by commercial farms which then supply local smallholders. Targeting surveillance on these potential hotspots would limit the risk of introduction and spread of animal diseases within the pig and poultry industry and better rationalize use of skilled manpower. Swill feeding is identified as a common practice in the region that represents a recognized risk factor for dissemination of pathogens to susceptible species. Illegal introduction of animals and animal products is suspected, but appears restricted to small holder farms in remote areas, limiting the risk of spread of transboundary animal diseases along the market chain. Introduction of undeclared goods hidden within a legal

  3. Assessing the Impact of a Pertussis Active Surveillance Program on Provider Testing Behavior, Minnesota 2005–2009

    PubMed Central

    Banerjee, Emily; Sweet, Kristin; Miller, Claudia; Ehresmann, Kristen

    2014-01-01

    Objectives. The Minnesota Department of Health, in collaboration with the Centers for Disease Control and Prevention, implemented the Pertussis Active Surveillance Project to better understand pertussis epidemiology. We evaluated the program’s impact. Methods. Clinics in 2 counties were offered free diagnostic testing and an educational presentation covering pertussis epidemiology. Clinics were identified as either active or intermittent, with active clinics testing 33% or more of the total number of months enrolled. We used generalized estimating equations to assess changes in provider testing behavior over the project period. Results. Ninety-seven clinics enrolled, with 38% classified as active. Active clinics were more likely to use the state lab for diagnostic testing and had a larger staff. During the project period, a decline in days coughing at the time of visit occurred in both jurisdictions. Conclusions. Providing clinics with free diagnostic testing influenced their participation levels. Among active clinics, results suggest changes in provider testing behavior over the course of the project. However, given the lack of robust participation, this resource-intensive strategy may not be a cost-effective approach to evaluating trends in pertussis epidemiology. PMID:24524507

  4. Comparison of results of fluconazole and voriconazole disk diffusion testing for Candida spp. with results from a central reference laboratory in the ARTEMIS DISK Global Antifungal Surveillance Program.

    PubMed

    Pfaller, Michael A; Boyken, Linda; Hollis, Richard J; Kroeger, Jennifer; Messer, Shawn A; Tendolkar, Shailesh; Diekema, Daniel J

    2009-09-01

    The accuracy of antifungal susceptibility testing is important for reliable resistance surveillance and for the clinical management of patients with serious infections due to Candida spp. Our primary objective was to compare the results of fluconazole and voriconazole disk diffusion testing of 3227 Candida spp. performed by 47 centers participating in the ARTEMIS program with disk diffusion and MIC results obtained by the central reference laboratory. The overall categoric agreement between participant disk diffusion test results and reference MIC results was 87% for fluconazole and 95.2% for voriconazole. Likewise good agreement was observed between participant disk diffusion test results and reference laboratory disk diffusion test results, with an agreement of 90.5%, 1% very major error (VME), and 3.4% major error (ME) for fluconazole and 94.2%, 1.1% VME, and 2.5% ME for voriconazole. The disk diffusion test was reliable for detecting those isolates of Candida spp. that were characterized as resistant to fluconazole and voriconazole by MIC testing. External quality assurance data obtained by surveillance programs such as the ARTEMIS Global Antifungal Surveillance Program ensure the generation of useful surveillance data and result in the continued improvement of antifungal susceptibility testing protocols.

  5. Markets

    Treesearch

    David N. Wear; Jeffrey Prestemon; Robert Huggett; Douglas Carter

    2013-01-01

    Key FindingsAlthough timber production in the South more than doubled from the 1960s to the late 1990s, output levels have declined over the last 10 years, signaling structural changes in timber markets.For softwood products, production declines are most clearly related to demand issues. Demand for softwood solid wood products...

  6. Low HIV testing among persons who inject drugs—National HIV Behavioral Surveillance, 20 U.S. cities, 2012✩

    PubMed Central

    Cooley, Laura A.; Wejnert, Cyprian; Spiller, Michael W.; Broz, Dita; Paz-Bailey, Gabriela

    2016-01-01

    Introduction Persons who inject drugs (PWID) continue to be disproportionately affected by HIV. HIV testing is key to reducing HIV transmission by increasing awareness of HIV status and linking HIV-positive persons to care. Using data from PWID participating in CDC’s National HIV Behavioral Surveillance (NHBS) system, we examined prevalence of recent HIV testing among PWID by certain characteristics to guide interventions to increase HIV testing. Methods We analyzed NHBS data from PWID 18 years or older recruited via respondent-driven sampling in 20 US cities in 2012. We examined demographic and behavioral factors associated with recent HIV testing (within 12 months before interview) using a Poisson model to calculate adjusted prevalence ratios (aPRs). Results Of 9555 PWID, 53% had recently tested for HIV. In multivariable analysis, HIV testing was more frequent among participants who visited a healthcare provider (aPR 1.50, P < 0.001), participated in alcohol or drug treatment (aPR 1.21, P < 0.001), or received an HIV prevention intervention (aPR 1.26, P < 0.001). HIV testing was also more frequent among participants who received free sterile syringes (aPR 1.12, P < 0.001). Discussion Only half of PWID participating in NHBS in 2012 reported recent HIV testing. HIV testing was more frequent among participants who accessed health and HIV prevention services. To increase HIV testing among PWID, it is important for providers in healthcare and HIV prevention settings to proactively assess risk factors for HIV, including injection drug use, and offer a wide range of appropriate interventions, such as HIV testing. PMID:27323649

  7. 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.

  8. 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

  9. Evaluation of Aryoseven Safety (Recombinant Activated Factor VII) in Patients with Bleeding Disorders (An Observational Post-Marketing Surveillance Study)

    PubMed Central

    Toogeh, Gholamreza; Abolghasemi, Hassan; Eshghi, Peyman; Managhchi, Mohammadreza; Shaverdi-niasari, Mohammadreza; Karimi, Katayoon; Roostaei, Samin; Emran, Neda; Abdollahi, Alireza

    2016-01-01

    Background: Recombinant activated factor VII induces hemostasis in patients with coagulopathy disorders. AryoSeven™ as a safe Iranian Recombinant activated factor VII has been available on our market. This study was performed to establish the safety of AryoSeven on patients with coagulopathy disorder. Methods: This single-center, descriptive, cross sectional study was carried out in Thrombus and Homeostasis Research Center ValiAsr Hospital during 2013-2014. Fifty one patients with bleeding disorders who received at least one dose of Aryoseven were enrolled. Patients’ demographic data and adverse effect of drug and reaction related to Aryoseven or previous usage of Recombinant activated FVII were recorded in questionnaires. Finally data were analyzed to compare side effects of Aryoseven and other Recombinant activated FVII brands. Results: Aryoseven was prescribed for 51 Patients. Of all participants with mean age 57.18+21.38 yr, 31 cases were male and 26 subjects had past history of recombinant activated FVII usage. Glanzman was the most frequent disorder followed by congenital FVII deficiency, hemophilia with inhibitors, factor 5 deficiency, acquired hemophilia, hemophilia A with inhibitor, and hemophilia A or B with inhibitor. The majority of bleeding episodes had occurred in joints. Three patients (5.9%) complained about adverse effects of Aryoseven vs. 11.5 % about adverse effects of other brands. However this difference was not significant, statistically. Conclusion: Based on monitor patients closely for any adverse events, we concluded that Aryoseven administration under careful weighing of benefit versus potential harm may comparable with other counterpart drugs. PMID:27799968

  10. Incidence and Trends of Infections with Pathogens Transmitted Commonly Through Food and the Effect of Increasing Use of Culture-Independent Diagnostic Tests on Surveillance - Foodborne Diseases Active Surveillance Network, 10 U.S. Sites, 2013-2016.

    PubMed

    Marder, Ellyn P; Cieslak, Paul R; Cronquist, Alicia B; Dunn, John; Lathrop, Sarah; Rabatsky-Ehr, Therese; Ryan, Patricia; Smith, Kirk; Tobin-D'Angelo, Melissa; Vugia, Duc J; Zansky, Shelley; Holt, Kristin G; Wolpert, Beverly J; Lynch, Michael; Tauxe, Robert; Geissler, Aimee L

    2017-04-21

    Foodborne diseases represent a substantial public health concern in the United States. CDC's Foodborne Diseases Active Surveillance Network (FoodNet) monitors cases reported from 10 U.S. sites* of laboratory-diagnosed infections caused by nine enteric pathogens commonly transmitted through food. This report describes preliminary surveillance data for 2016 on the nine pathogens and changes in incidences compared with 2013-2015. In 2016, FoodNet identified 24,029 infections, 5,512 hospitalizations, and 98 deaths caused by these pathogens. The use of culture-independent diagnostic tests (CIDTs) by clinical laboratories to detect enteric pathogens has been steadily increasing since FoodNet began surveying clinical laboratories in 2010 (1). CIDTs complicate the interpretation of FoodNet surveillance data because pathogen detection could be affected by changes in health care provider behaviors or laboratory testing practices (2). Health care providers might be more likely to order CIDTs because these tests are quicker and easier to use than traditional culture methods, a circumstance that could increase pathogen detection (3). Similarly, pathogen detection could also be increasing as clinical laboratories adopt DNA-based syndromic panels, which include pathogens not often included in routine stool culture (4,5). In addition, CIDTs do not yield isolates, which public health officials rely on to distinguish pathogen subtypes, determine antimicrobial resistance, monitor trends, and detect outbreaks. To obtain isolates for infections identified by CIDTs, laboratories must perform reflex culture(†); if clinical laboratories do not, the burden of culturing falls to state public health laboratories, which might not be able to absorb that burden as the adoption of these tests increases (2). Strategies are needed to preserve access to bacterial isolates for further characterization and to determine the effect of changing trends in testing practices on surveillance.

  11. Analysis of "Seven Year Surveillance of the Clinical Performance of a Blood Glucose Test-Strip Product".

    PubMed

    Krouwer, Jan S

    2017-09-01

    The article titled "Seven Year Surveillance of the Clinical Performance of a Blood Glucose Test-Strip Product" by Setford and coworkers in this issue of Journal of Diabetes Science and Technology is an impressive study showing that over 7 years in three clinics, using multiple reagent lots, a total of 73 600 samples met the ISO 15197 2015 standard with no results in the D or E zones of a Parkes glucose meter error grid. Three requirements are suggested for a clinically acceptable glucose meter. The authors provide strong evidence for meeting two requirements but fail to provide summarized data about the number of nonnumeric results. Finally, the authors overstate some results, called "spin" by some which is not necessary. The superb results should stand on their own.

  12. School Choice in Suburbia: Test Scores, Race, and Housing Markets

    ERIC Educational Resources Information Center

    Dougherty, Jack; Harelson, Jeffrey; Maloney, Laura; Murphy, Drew; Smith, Russell; Snow, Michael; Zannoni, Diane

    2009-01-01

    Home buyers exercise school choice when shopping for a private residence due to its location in a public school district or attendance area. In this quantitative study of one Connecticut suburban district, we measure the effect of elementary school test scores and racial composition on home buyers' willingness to purchase single-family homes over…

  13. School Choice in Suburbia: Test Scores, Race, and Housing Markets

    ERIC Educational Resources Information Center

    Dougherty, Jack; Harelson, Jeffrey; Maloney, Laura; Murphy, Drew; Smith, Russell; Snow, Michael; Zannoni, Diane

    2009-01-01

    Home buyers exercise school choice when shopping for a private residence due to its location in a public school district or attendance area. In this quantitative study of one Connecticut suburban district, we measure the effect of elementary school test scores and racial composition on home buyers' willingness to purchase single-family homes over…

  14. Foucault, surveillance, and carbon monoxide testing within stop-smoking services.

    PubMed

    Grant, Aimee; Ashton, Kathryn; Phillips, Rhiannon

    2015-07-01

    Health professionals have adopted proactive testing for early evidence of disease. Researchers have identified that this leads to enumerated understandings and shapes behavior in productive ways. Smoking-cessation advisors regularly test clients for carbon monoxide (CO), but client views of this had not previously been explored. We interviewed 23 clients of a United Kingdom-based stop-smoking service regarding their experiences of CO testing. The majority of participants were successful quitters. We used ATLAS.ti 7 as a data-management tool during structured qualitative analysis. Our findings reveal that clients believed the results of their CO tests. Many became enumerated in their understanding, and thus placed themselves in a hierarchy with other members of their group. Almost all clients found that knowing their CO test score was motivating. We conclude that additional research is needed to understand the experiences of CO testing among clients who do not quit.

  15. Foucault, Surveillance, and Carbon Monoxide Testing Within Stop-Smoking Services

    PubMed Central

    Ashton, Kathryn; Phillips, Rhiannon

    2015-01-01

    Health professionals have adopted proactive testing for early evidence of disease. Researchers have identified that this leads to enumerated understandings and shapes behavior in productive ways. Smoking-cessation advisors regularly test clients for carbon monoxide (CO), but client views of this had not previously been explored. We interviewed 23 clients of a United Kingdom-based stop-smoking service regarding their experiences of CO testing. The majority of participants were successful quitters. We used ATLAS.ti 7 as a data-management tool during structured qualitative analysis. Our findings reveal that clients believed the results of their CO tests. Many became enumerated in their understanding, and thus placed themselves in a hierarchy with other members of their group. Almost all clients found that knowing their CO test score was motivating. We conclude that additional research is needed to understand the experiences of CO testing among clients who do not quit. PMID:25294348

  16. Socioeconomic influences on the effects of a genetic testing direct-to-consumer marketing campaign.

    PubMed

    Bowen, D J; Harris, J; Jorgensen, C M; Myers, M F; Kuniyuki, A

    2010-01-01

    Direct-to-consumer marketing of genetic tests is beginning to appear in select markets, and little independent evaluation has been conducted on the effects of this marketing on consumer attitudes or behavior. The purpose of this paper is to identify the effects of socioeconomic status on women's reactions to such a campaign, including knowledge of the test, perceptions of personal risk, communications with others about the test, and interest in pursuing the test. The only United States provider of genetic testing for breast and ovarian cancer susceptibility (BRCA1/2 testing) conducted a pilot marketing campaign that targeted women aged 25-54 and their health care providers in 2 cities, Atlanta, Ga., and Denver, Colo. The design for the evaluation was a post campaign consumer survey, based on a cross-sectional stratified random sample of women in the 2 intervention sites and 2 comparison sites. The campaign had no differential impact by socioeconomic status. However, there was a consistent relationship between socioeconomic status and several outcome variables, including knowledge of the test, beliefs about the test, and desire to know about genetic risk. These data indicate that socioeconomic status may play a role in uptake of genetic services, regardless of response to a media campaign. Copyright 2009 S. Karger AG, Basel.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Surveillance of Avian H7N9 Virus in Various Environments of Zhejiang Province, China before and after Live Poultry Markets Were Closed in 2013–2014

    PubMed Central

    Wang, Xiaoxiao; Liu, Shelan; Mao, Haiyan; Yu, Zhao; Chen, Enfu; Chai, Chengliang

    2015-01-01

    Background To date, there have been a total of 637 laboratory-confirmed cases of human infection with avian influenza A (H7N9) virus across mainland China, with 28% (179/637) of these reported in Zhejiang Province. Surveillance of avian H7N9 virus was conducted to investigate environmental contamination during H7N9 outbreaks. We sought to evaluate the prevalence of H7N9 in the environment, and the effects of poultry market closures on the incidence of human H7N9 cases. Methods We collected 6740 environmental samples from 751 sampling sites across 11 cities of Zhejiang Province (China) between January 2013 and March 2014. The presence of H7N9 was determined by reverse transcription polymerase chain reaction, with prevalence compared between sites and over time. The relationship between environmental contamination and human cases of H7N9 infection were analyzed using Spearman’s ranked correlation coefficient. Results Of the 6740 samples, 10.09% (680/6740) were H7N9-positive. The virus was found to circulate seasonally, and peaked during the spring and winter of 2013–2014. The prevalence of the virus decreased from the north to the southeast of the province, coinciding with the geographical distribution of human H7N9 cases. Compared with other sampling sites, live poultry markets (LPMs) had the highest prevalence of H7N9 virus at 13.94% (667/4784). Of the various sample types analyzed, virus prevalence was highest for chopping board swabs at 15.49% (110/710). The prevalence of the virus in the environment positively correlated with the incidence of human H7N9 cases (r2 = 0.498; P < 0.01). Cities with a higher incidence of human H7N9 cases also had a higher prevalence of H7N9 among samples and at sampling sites. Following the closure of LPMs at the end of January 2014, the prevalence of H7N9 decreased from 19.18% (487/2539) to 6.92% (79/1141). This corresponded with a decrease in the number of human H7N9 cases reported. Conclusions The prevalence of H7N9 virus in

  6. 17 CFR 38.604 - Financial surveillance.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 17 Commodity and Securities Exchanges 1 2013-04-01 2013-04-01 false Financial surveillance. 38.604 Section 38.604 Commodity and Securities Exchanges COMMODITY FUTURES TRADING COMMISSION DESIGNATED CONTRACT MARKETS Financial Integrity of Transactions § 38.604 Financial surveillance. A designated contract market...

  7. Bootstrap confidence intervals and bias correction in the estimation of HIV incidence from surveillance data with testing for recent infection.

    PubMed

    Carnegie, Nicole Bohme

    2011-04-15

    The incidence of new infections is a key measure of the status of the HIV epidemic, but accurate measurement of incidence is often constrained by limited data. Karon et al. (Statist. Med. 2008; 27:4617–4633) developed a model to estimate the incidence of HIV infection from surveillance data with biologic testing for recent infection for newly diagnosed cases. This method has been implemented by public health departments across the United States and is behind the new national incidence estimates, which are about 40 per cent higher than previous estimates. We show that the delta method approximation given for the variance of the estimator is incomplete, leading to an inflated variance estimate. This contributes to the generation of overly conservative confidence intervals, potentially obscuring important differences between populations. We demonstrate via simulation that an innovative model-based bootstrap method using the specified model for the infection and surveillance process improves confidence interval coverage and adjusts for the bias in the point estimate. Confidence interval coverage is about 94–97 per cent after correction, compared with 96–99 per cent before. The simulated bias in the estimate of incidence ranges from −6.3 to +14.6 per cent under the original model but is consistently under 1 per cent after correction by the model-based bootstrap. In an application to data from King County, Washington in 2007 we observe correction of 7.2 per cent relative bias in the incidence estimate and a 66 per cent reduction in the width of the 95 per cent confidence interval using this method. We provide open-source software to implement the method that can also be extended for alternate models.

  8. Uptake of genetic counseling, genetic testing and surveillance in hereditary malignant melanoma (CDKN2A) in Norway.

    PubMed

    Levin, Trine; Mæhle, Lovise

    2016-11-01

    Germline mutations in the CDKN2A gene are associated with an increased risk of malignant melanoma and pancreatic cancer. In order to find out if the behavior pattern in families with a CDKN2A mutation is similar to what we previously have described in families with a BRCA1 mutation, we have studied the uptake of genetic services in probands and their relatives. We describe whether they attend genetic counseling when invited, whether they want a mutation test after being counseled and whether they adhere to recommendations for surveillance. 66 % (95/144) of first-degree relatives to mutation carriers contacted us within the study period. 98 % (126/128) of all relatives who came for genetic counseling decided on genetic testing for their family's mutation, and 93 % (66/71) of all mutation carriers wanted referral to yearly skin examinations. Female relatives had a significantly higher uptake of genetic services compared to males, similar to the findings in families with a BRCA1 mutation. Uptake of genetic services in general in families with a CDKN2A mutation is high. Females seem to have a higher interest in genetic testing than males, regardless of gene mutated.

  9. Quality of information accompanying on-line marketing of home diagnostic tests.

    PubMed

    Datta, Adrija K; Selman, Tara J; Kwok, Tony; Tang, Teresa; Khan, Khalid S

    2008-01-01

    To assess the quality of information provided to consumers by websites marketing medical home diagnostic tests. A cross-sectional analysis of a database developed from searching targeted websites. Data sources were websites written in English which marketed medical home diagnostic tests. A meta-search engine was used to identify the first 20 citations for each type of home diagnostic medical test. Relevant websites limited to those written in English were reviewed independently and in triplicate, with disputes resolved by two further reviewers. Information on the quality of these sites was extracted using a pre-piloted performer. 168 websites were suitable for inclusion in the review. The quality of these sites showed marked variation. Only 24 of 168 (14.2%) complied with at least three-quarters of the quality items and just over half (95 of 168, 56.5%) reported official approval or certification of the test. Information on accuracy of the test marketed was reported by 87 of 168 (51.7%) websites, with 15 of 168 (8.9%) providing a scientific reference. Instructions for use of the product were found in 97 of 168 (57.9%). However, the course of action to be taken after obtaining the test result was stated in only 63 of 168 (37.5%) for a positive result and 43 of 168 (25.5%) for a negative result. The quality of information posted on commercial websites marketing home tests online is unsatisfactory and potentially misleading for consumers.

  10. A social work plan to promote HIV testing: A social marketing approach.

    PubMed

    Morgan-Siebe, J P

    2017-03-01

    Many people living with human immunodeficiency virus (HIV) do not know that they are infected. It is important for infected persons to get tested for HIV in order to be diagnosed and medically treated. HIV has no known cure, but it can be controlled and sometimes prevented with proper medical care. The social work profession has ideal positioning to be extraordinarily helpful in work that promotes HIV testing, leading to reducing then eliminating new HIV diagnoses. Social marketing interventions, along with audience segmenting are explained. Specific attention is given to two separate subjects-minority health disparities and impulsive and/or sensation seeking sex practices-to showcase the versatility of social marketing in the promotion of HIV testing. Further ideas about how social workers can participate in these interprofessional social marketing campaigns are provided.

  11. HIV incidence estimate combining HIV/AIDS surveillance, testing history information and HIV test to identify recent infections in Lazio, Italy

    PubMed Central

    2012-01-01

    Background The application of serological methods in HIV/AIDS routine surveillance systems to identify persons with recently acquired HIV infection has been proposed as a tool which may provide an accurate description of the current transmission patterns of HIV. Using the information about recent infection it is possible to estimate HIV incidence, according to the model proposed by Karon et al. in 2008, that accounts for the effect of testing practices on the number of persons detected as recently infected. Methods We used data from HIV/AIDS surveillance in the period 2004-2008 to identify newly diagnosed persons. These were classified with recent/non-recent infection on the basis of an avidity index result, or laboratory evidence of recently acquired infection (i.e., previous documented negative HIV test within 6 months; or presence of HIV RNA or p24 antigen with simultaneous negative/indeterminate HIV antibody test). Multiple imputation was used to impute missing information. The incidence estimate was obtained as the number of persons detected as recently infected divided by the estimated probability of detection. Estimates were stratified by calendar year, transmission category, gender and nationality. Results During the period considered 3,633 new HIV diagnoses were reported to the regional surveillance system. Applying the model, we estimated that in 2004-2008 there were 5,465 new infections (95%CI: 4,538-6,461); stratifying by transmission category, the estimated number of infections was 2,599 among heterosexual contacts, 2,208 among men-who-have-sex-with-men, and 763 among injecting-drug-users. In 2008 there were 952 (625-1,229) new HIV infections (incidence of 19.9 per 100,000 person-years). In 2008, for men-who-have-sex-with-men (691 per 100,000 person-years) and injecting drug users (577 per 100,000 person-years) the incidence remained comparatively high with respect to the general population, although a decreasing pattern during 2004-2008 was observed

  12. Comparison of Height, Weight, and Body Mass Index Data from State-Mandated School Physical Fitness Testing and a Districtwide Surveillance Project

    ERIC Educational Resources Information Center

    Khaokham, Christina B.; Hillidge, Sharon; Serpas, Shaila; McDonald, Eric; Nader, Philip R.

    2015-01-01

    Background: Approximately one third of California school-age children are overweight or obese. Legislative approaches to assessing obesity have focused on school-based data collection. During 2010-2011, the Chula Vista Elementary School District conducted districtwide surveillance and state-mandated physical fitness testing (PFT) among fifth grade…

  13. Comparison of Height, Weight, and Body Mass Index Data from State-Mandated School Physical Fitness Testing and a Districtwide Surveillance Project

    ERIC Educational Resources Information Center

    Khaokham, Christina B.; Hillidge, Sharon; Serpas, Shaila; McDonald, Eric; Nader, Philip R.

    2015-01-01

    Background: Approximately one third of California school-age children are overweight or obese. Legislative approaches to assessing obesity have focused on school-based data collection. During 2010-2011, the Chula Vista Elementary School District conducted districtwide surveillance and state-mandated physical fitness testing (PFT) among fifth grade…

  14. Surveillance of giardiasis in Northwest England 1996-2006: impact of an enzyme immunoassay test.

    PubMed

    Ellam, H; Verlander, N Q; Lamden, K; Cheesbrough, J S; Durband, C A; James, S

    2008-09-11

    The incidence of giardiasis in Central Lancashire increased following the introduction of a sensitive enzyme immunoassay diagnostic test in November 2002. We compared the epidemiological trends for 1996-2006 in Central Lancashire with a control area which used a standard wet preparation diagnostic method throughout. Poisson regression modelling was used to investigate trends in giardiasis before and after the introduction of the test. In the control area, incidence of giardiasis was four per 100,000 in 2005. In contrast, in Central Lancashire, the rates increased in temporal association with the introduction of the enzyme immunoassay test from 10.1 per 100,000 population in 2002 to 33.6 per 100,000 in 2006. The increase in giardiasis was unexplained by local factors including travel, outbreaks or sampling trends. The increase in giardiasis occurred in all age groups except for males aged 0-14 years and was most marked in males aged 25-44 years. The relative risk for trend post-test introduction in Central Lancashire was 1.11 (95% CI, 1.01-1.23). This suggests that the increase in giardiasis following the introduction of the sensitive enzyme immunoassay test was at least in part due to improved detection. There appears to be considerable under-diagnosis of giardiasis, particularly in adults. Additional research is required to evaluate the enzyme immunoassay test more widely. The test may assist in standardisation of diagnostic methods for giardiasis and enable more accurate estimation of disease burden and transmission routes.

  15. Evaluation of six serological ELISA kits available in Italy as screening tests for equine infectious anaemia surveillance.

    PubMed

    Nardini, Roberto; Autorino, Gian Luca; Issel, Charles J; Cook, R Frank; Ricci, Ida; Frontoso, Raffaele; Rosone, Francesca; Scicluna, Maria Teresa

    2017-04-14

    precocity are preferable as a screening test in EIA surveillance programmes to the AGID tests examined. These two tests can be incorporated in a serial diagnostic pathway to improve the efficacy of a surveillance plan.

  16. Evaluation of a Rapid Diagnostic Test for Yaws Infection in a Community Surveillance Setting

    PubMed Central

    Marks, Michael; Goncalves, Adriana; Vahi, Ventis; Sokana, Oliver; Puiahi, Elliot; Zhang, Zaixing; Dalipanda, Tenneth; Bottomley, Christian; Mabey, David; Solomon, Anthony W.

    2014-01-01

    Yaws is a non-venereal treponemal infection caused by Treponema pallidum ssp. pertenue. The WHO has launched a worldwide control programme, which aims to eradicate yaws by 2020. The development of a rapid diagnostic test (RDT) for serological diagnosis in the isolated communities affected by yaws is a key requirement for the successful implementation of the WHO strategy. We conducted a study to evaluate the utility of the DPP test in screening for yaws, utilizing samples collected as part of a community prevalence survey conducted in the Solomon Islands. 415 serum samples were tested using both traditional syphilis serology (TPPA and quantitative RPR) and the Chembio DPP Syphilis Screen and Confirm RDT. We calculated the sensitivity and specificity of the RDT as compared to gold standard serology. The sensitivity of the RDT against TPPA was 58.5% and the specificity was 97.6%. The sensitivity of the RDT against RPR was 41.7% and the specificity was 95.2%. The sensitivity of the DPP was strongly related to the RPR titre with a sensitivity of 92.0% for an RPR titre of >1/16. Wider access to DPP testing would improve our understanding of worldwide yaws case reporting and the test may play a key role in assessing patients presenting with yaws like lesions in a post-mass drug administration (MDA) setting. PMID:25211018

  17. Development and field testing of a Light Aircraft Oil Surveillance System (LAOSS)

    NASA Technical Reports Server (NTRS)

    Burns, W.; Herz, M. J.

    1976-01-01

    An experimental device consisting of a conventional TV camera with a low light level photo image tube and motor driven polarized filter arrangement was constructed to provide a remote means of discriminating the presence of oil on water surfaces. This polarized light filtering system permitted a series of successive, rapid changes between the vertical and horizontal components of reflected polarized skylight and caused the oil based substances to be more easily observed and identified as a flashing image against a relatively static water surface background. This instrument was flight tested, and the results, with targets of opportunity and more systematic test site data, indicate the potential usefulness of this airborne remote sensing instrument.

  18. Syndromic Surveillance and Outbreak Detection Using Automated Microbiologic Laboratory Test Order Data

    DTIC Science & Technology

    2007-06-15

    Laboratory Test Order Data" Ph.D. Degrees Interdisciplinary -Emerging Infectious Diseases -Molecular & Cell Biology - Neuroscience Departmental...LA MADDALENA 0855 N CLINIC N 1 BMC NAVWPNCEN CHINA LAKE 0212 N CLINIC Y 13 BMC NAVWPNSFAC ST. MAWGAN 1179 N CLINIC N 0 BMC NSA BAHRAIN 1170 N

  19. 17 CFR 38.156 - Automated trade surveillance system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 17 Commodity and Securities Exchanges 1 2014-04-01 2014-04-01 false Automated trade surveillance... DESIGNATED CONTRACT MARKETS Compliance With Rules § 38.156 Automated trade surveillance system. A designated contract market must maintain an automated trade surveillance system capable of detecting and investigating...

  20. 17 CFR 38.156 - Automated trade surveillance system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 17 Commodity and Securities Exchanges 1 2013-04-01 2013-04-01 false Automated trade surveillance... DESIGNATED CONTRACT MARKETS Compliance With Rules § 38.156 Automated trade surveillance system. A designated contract market must maintain an automated trade surveillance system capable of detecting and investigating...

  1. Field Evaluation of a Coproantigen Detection Test for Fascioliasis Diagnosis and Surveillance in Human Hyperendemic Areas of Andean Countries

    PubMed Central

    Valero, María Adela; Periago, María Victoria; Pérez-Crespo, Ignacio; Angles, René; Villegas, Fidel; Aguirre, Carlos; Strauss, Wilma; Espinoza, José R.; Herrera, Patricia; Terashima, Angelica; Tamayo, Hugo; Engels, Dirk; Gabrielli, Albis Francesco; Mas-Coma, Santiago

    2012-01-01

    Background Emergence of human fascioliasis prompted a worldwide control initiative including a pilot study in a few countries. Two hyperendemic areas were chosen: Huacullani, Northern Altiplano, Bolivia, representing the Altiplanic transmission pattern with high prevalences and intensities; Cajamarca valley, Peru, representing the valley pattern with high prevalences but low intensities. Coprological sample collection, transport and study procedures were analyzed to improve individual diagnosis and subsequent treatments and surveillance activities. Therefore, a coproantigen-detection technique (MM3-COPRO ELISA) was evaluated, using classical techniques for egg detection for comparison. Methodology and Findings A total of 436 and 362 stool samples from schoolchildren of Huacullani and Cajamarca, respectively, were used. Positive samples from Huacullani were 24.77% using the MM3-COPRO technique, and 21.56% using Kato-Katz. Positive samples from Cajamarca were 11.05% using MM3-COPRO, and 5.24% using rapid sedimentation and Kato-Katz. In Huacullani, using Kato-Katz as gold standard, sensitivity and specificity were 94.68% and 98.48%, respectively, and using Kato-Katz and COPRO-ELISA test together, they were 95.68% and 100%. In Cajamarca, using rapid sedimentation and Kato-Katz together, results were 94.73% and 93.58%, and using rapid sedimentation, Kato-Katz and copro-ELISA together, they were 97.56% and 100%, respectively. There was no correlation between coproantigen detection by optical density (OD) and infection intensity by eggs per gram of feces (epg) in Cajamarca low burden cases (<400 epg), nor in Huacullani high burden cases (≥400 epg), although there was in Huacullani low burden cases (<400 epg). Six cases of egg emission appeared negative by MM3-COPRO, including one with a high egg count (1248 epg). Conclusions The coproantigen-detection test allows for high sensitivity and specificity, fast large mass screening capacity, detection in the chronic phase

  2. Neuraminidase Inhibitor Susceptibility Testing in Human Influenza Viruses: A Laboratory Surveillance Perspective

    PubMed Central

    Okomo-Adhiambo, Margaret; Sleeman, Katrina; Ballenger, Kristina; Nguyen, Ha T.; Mishin, Vasiliy P.; Sheu, Tiffany G.; Smagala, James; Li, Yan; Klimov, Alexander I.; Gubareva, Larisa V.

    2010-01-01

    Neuraminidase inhibitors (NAIs) are vital in managing seasonal and pandemic influenza infections. NAI susceptibilities of virus isolates (n = 5540) collected during the 2008–2009 influenza season were assessed in the chemiluminescent neuraminidase inhibition (NI) assay. Box-and-whisker plot analyses of log-transformed IC50s were performed for each virus type/subtype and NAI to identify outliers which were characterized based on a statistical cutoff of IC50 >3 interquartile ranges (IQR) from the 75th percentile. Among 1533 seasonal H1N1 viruses tested, 1431 (93.3%) were outliers for oseltamivir; they all harbored the H275Y mutation in the neuraminidase (NA) and were reported as oseltamivir-resistant. Only 15 (0.7%) of pandemic 2009 H1N1 viruses tested (n = 2259) were resistant to oseltamivir. All influenza A(H3N2) (n = 834) and B (n = 914) viruses were sensitive to oseltamivir, except for one A(H3N2) and one B virus, with D151V and D197E (D198E in N2 numbering) mutations in the NA, respectively. All viruses tested were sensitive to zanamivir, except for six seasonal A(H1N1) and several A(H3N2) outliers (n = 22) which exhibited cell culture induced mutations at residue D151 of the NA. A subset of viruses (n = 1058) tested for peramivir were sensitive to the drug, with exception of H275Y variants that exhibited reduced susceptibility to this NAI. This study summarizes baseline susceptibility patterns of seasonal and pandemic influenza viruses, and seeks to contribute towards criteria for defining NAI resistance. PMID:21994620

  3. Testing the weak-form efficiency of the WTI crude oil futures market

    NASA Astrophysics Data System (ADS)

    Jiang, Zhi-Qiang; Xie, Wen-Jie; Zhou, Wei-Xing

    2014-07-01

    The weak-form efficiency of energy futures markets has long been studied and empirical evidence suggests controversial conclusions. In this work, nonparametric methods are adopted to estimate the Hurst indexes of the WTI crude oil futures prices (1983-2012) and a strict statistical test in the spirit of bootstrapping is put forward to verify the weak-form market efficiency hypothesis. The results show that the crude oil futures market is efficient when the whole period is considered. When the whole series is divided into three sub-series separated by the outbreaks of the Gulf War and the Iraq War, it is found that the Gulf War reduced the efficiency of the market. If the sample is split into two sub-series based on the signing date of the North American Free Trade Agreement, the market is found to be inefficient in the sub-periods during which the Gulf War broke out. The same analysis on short-time series in moving windows shows that the market is inefficient only when some turbulent events occur, such as the oil price crash in 1985, the Gulf war, and the oil price crash in 2008.

  4. Relationship of Sentence Skills Test Scores and Final Course Grades in Marketing 100.

    ERIC Educational Resources Information Center

    Ryan, Nancy

    1996-01-01

    Describes a study examining the relationship between scores on a Sentence Skills component of an English placement test and final course grades in a community college marketing course. Finds a significant positive correlation between scores and final grades, but one not strong enough to be used for predictive purposes. (13 citations) (BCY)

  5. 78 FR 2273 - Canned Tuna Deviating From Identity Standard; Temporary Permit for Market Testing

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-10

    ... HUMAN SERVICES Food and Drug Administration Canned Tuna Deviating From Identity Standard; Temporary Permit for Market Testing AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food... Sea International (the applicant). We are announcing that we have issued a temporary permit to...

  6. Surveillance Report. Stage 1. Dissected Motors. Phase 9. Propellant and Component Testing

    DTIC Science & Technology

    1978-03-01

    for at least two years past the oldest data point. Future testing will be conducted on dissected motors. ii ! / .’ -- • - - TABLE OF CONTENTS Abstract ii ...000 [r mor-I C1o U.1 + -+~- a zrZZ C coa~aa: F-1 r uuu)Lnio II U~,. (D\\Q Liin t if z~ .- ~~iLL~i I !) 0 In S-S S- -Irj ) I 4o F -U o-zzo - 0 )4- I.L...cu- 4.i91- I-t- a I-, 000z 00-% - cmacraJ~L z \\ U)uuo to U- U-U ( - .-..- C +.00 0 u.J (n (n(n i 0J 0 o 0 - [hJ 1199C9999 II (A (A T4 X L3 *0 IL

  7. Development and validation of an indirect ELISA as a confirmatory test for surveillance of infectious bovine rhinotracheitis in vaccinated herds.

    PubMed

    Bertolotti, Luigi; Muratore, Elvira; Nogarol, Chiara; Caruso, Claudio; Lucchese, Laura; Profiti, Margherita; Anfossi, Laura; Masoero, Loretta; Nardelli, Stefano; Rosati, Sergio

    2015-12-08

    Bovine herpesvirus 1 (BoHV1) is a member of the viral subfamily of Alphaherpesvirinae that infects various species, including cattle, sheep, and goats. The virus causes infectious bovine rhinotracheitis (IBR), which is included in a European list of diseases that may require control and eradication programs. The lack of confirmatory tests affects the validity of diagnostic tools, especially those used for vaccinated herds. In this study, we report the development and validation of an indirect enzyme-linked immunosorbent assay (ELISA) based on BoHV1 glycoprotein E, which was expressed as a secreted recombinant antigen in a mammalian cell system. The performance of the new rec-gE ELISA was compared with that of commercially available indirect and/or blocking ELISAs. The sample set included blood sera from animals from IBR-positive farms, IBR-free farms, and marker-vaccinated farms. The indirect ELISA proposed in this study is based on antibody reactivity against BoHV1 gE, and showed high sensitivity and specificity (98.41 and 99.76 %, respectively). The ELISA performed well, in terms of both its diagnostic sensitivity and specificity, and as a confirmatory methodology, and therefore should improve the diagnostic protocols used for IBR surveillance.

  8. Outcome of Diagnostic Tests Using Samples from Patients with Culture-Proven Human Monocytic Ehrlichiosis: Implications for Surveillance

    PubMed Central

    Childs, James E.; Sumner, John W.; Nicholson, William L.; Massung, Robert F.; Standaert, Steven M.; Paddock, Christopher D.

    1999-01-01

    We describe the concordance among results from various laboratory tests using samples derived from nine culture-proven cases of human monocytic ehrlichiosis (HME) caused by Ehrlichia chaffeensis. A class-specific indirect immunofluorescence assay for immunoglobulin M (IgM) and IgG, using E. chaffeensis antigen, identified 44 and 33% of the isolation-confirmed HME patients on the basis of samples obtained at initial clinical presentation, respectively; detection of morulae in blood smears was similarly insensitive (22% positive). PCR amplifications of ehrlichial DNA targeting the 16S rRNA gene, the variable-length PCR target gene, and the groESL operon were positive for whole blood specimens obtained from all patients at initial presentation. As most case definitions of HME require a serologic response with compatible illness for a categorization of even probable disease, PCR would have been required to confirm the diagnosis of HME in all nine of these patients without the submission of a convalescent-phase serum sample. These data suggest that many, if not most, cases of HME in patients who present early in the course of the disease may be missed and underscore the limitations of serologically based surveillance systems. PMID:10449489

  9. The Utility of Malaria Rapid Diagnostic Tests as a Tool in Enhanced Surveillance for Malaria Elimination in Vanuatu

    PubMed Central

    Guintran, Jean-Olivier; Iata, Harry; Anderson, Karen; Nausien, Johnny; Gresty, Karryn J; Waters, Norman C.; Vestergaard, Lasse S.; Taleo, George; Cheng, Qin

    2016-01-01

    Background As part of efforts to eliminate malaria, Vanuatu has piloted the implementation of enhanced malaria surveillance and response strategies since 2011. This involves passive case detection (PCD) in health facilities, proactive case detection (Pro-ACD) and reactive case detection (Re-ACD) in communities using malaria rapid diagnostic tests (RDTs). While RDTs improve case management, their utility for detection of malaria infections in ACDs in this setting is unclear. Methods The utility of malaria RDTs as diagnostic tools was evaluated in PCD, in five rounds of Pro-ACDs and five rounds of Re-ACDs conducted in Tafea and Torba Provinces between 2011 and 2014. The number of malaria infections detected by RDTs was compared to that detected by PCR from collected used-RDTs. Results PCD in Tafea Province (2013) showed a RDT-positive rate of 0.21% (2/939) and a PCR-positive rate of 0.44% (2/453), indicating less than 1% of suspected malaria cases in Tafea Province were due to malaria. In Pro-ACDs conducted in Tafea and Torba Provinces, RDT-positive rates in 2013 and 2014 were 0.14% (3/2145) and 0% (0/2823), respectively, while the corresponding PCR-positive rates were 0.72% (9/1242) and 0.79% (9/1141). PCR identified villages in both provinces appearing to be transmission foci with a small number of low-density infections, mainly P. falciparum infections. In five rounds of Re-ACD, RDTs did not identify any additional infections while PCR detected only one among 173 subjects screened. Conclusions PCD and Pro-ACDs demonstrate that both Tafea and Torba Provinces in Vanuatu has achieved very low malaria prevalence. In these low-transmission areas, conducting Pro-ACD and Re-ACDs using RDTs appears not cost-effective and may have limited impact on interrupting malaria transmission due to the small number of infections identified by RDTs and considerable operational resources invested. More sensitive, field deployable and affordable diagnostic tools will improve malaria

  10. Prospective study of surveillance testing for metastasis in 100 high-risk uveal melanoma patients.

    PubMed

    Piperno-Neumann, S; Servois, V; Mariani, P; Plancher, C; Lévy-Gabriel, C; Lumbroso-Le Rouic, L; Couturier, J; Asselain, B; Desjardins, L; Cassoux, N

    2015-06-01

    Despite advances in the local treatment of UM, half of patients develop metastases typically to the liver with poor survival. Microscopic complete surgical resection (R0) of liver metastases improves survival in high selected patients. Early identification of high-risk patients might allow detection of asymptomatic metastases, and increase R0 liver surgery rate. From October 2006 to December 2009, we conducted a prospective study to detect early minimal lesions with 6-monthly liver function tests (LFTs) and liver MRI in 100 high-risk patients. High risk was defined by primary tumor clinical or genomic criteria: thickness>8mm or diameter>15 mm, or extra-scleral extension, or monosomy 3 by FISH or aCGH. With a median follow-up of 49 months, the 5-year metastasis-free survival and overall survival were 47 and 33%, respectively. Of the 60 patients who became metastatic, 50 (83%) had exclusive liver metastasis. LFTs screening had no sufficient accurary, but biannual MRI showed high predictive value to detect metastasis and select patients eligible for curative surgery: 25/50 underwent laparotomy and among them, 8/25 (32%) had a R0 surgery. Median survival after metastasis was 14 months, mean survival reached 40 months in the R0 resected population. Six-monthly liver MRI screening is recommended in patients with large tumors or genomic high risk in order to detect early patient candidates to complete resection of liver metastases. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

  11. Strategic regulatory entry deterrence: an empirical test in the ophthalmic market.

    PubMed

    Haas-Wilson, D

    1989-12-01

    This paper provides an empirical test of the theory of strategic regulatory entry deterrence--the theory that subgroups of firms within an industry will use the regulatory process to increase rivals' costs and thereby deter rivals' entry. The results suggest that the commercial practice restrictions present in the ophthalmic industry deterred chain optical firms' entry into the market. This result in combination with earlier findings that the restrictions increase optometrists' prices suggests that cost-raising strategies can be used to disadvantage rivals or drive them out of the market without the need to lower price.

  12. Health facility-based malaria surveillance: the effects of age, area of residence and diagnostics on test positivity rates.

    PubMed

    Francis, Damon; Gasasira, Anne; Kigozi, Ruth; Kigozi, Simon; Nasr, Sussann; Kamya, Moses R; Dorsey, Grant

    2012-07-07

    The malaria test positivity rate (TPR) is increasingly used as an indicator of malaria morbidity because TPR is based on laboratory-confirmed cases and is simple to incorporate into existing surveillance systems. However, temporal trends in TPR may reflect changes in factors associated with malaria rather than true changes in malaria morbidity. This study examines the effects of age, area of residence and diagnostic test on TPR at two health facilities in regions of Uganda with differing malaria endemicity. The analysis included data from diagnostic blood smears performed at health facilities in Walukuba and Aduku between January 2009 and December 2010. The associations between age and time and between age and TPR were evaluated independently to determine the potential for age to confound temporal trends in TPR. Subsequently, differences between observed TPR and TPR adjusted for age were compared to determine if confounding was present. A similar analysis was performed for area of residence. Temporal trends in observed TPR were compared to trends in TPR expected using rapid diagnostic tests, which were modelled based upon sensitivity and specificity in prior studies. Age was independently associated with both TPR and time at both sites. At Aduku, age-adjusted TPR increased relative to observed TPR due to the association between younger age and TPR and the gradual increase in age distribution. At Walukuba, there were no clear differences between observed and age-adjusted TPR. Area of residence was independently associated with both TPR and time at both sites, though there were no clear differences in temporal trends in area of residence-adjusted TPR and observed TPR at either site. Expected TPR with pLDH- and HRP-2-based rapid diagnostic tests (RDTs) was higher than observed TPR at all time points at both sites. Adjusting for potential confounders such as age and area of residence can ensure that temporal trends in TPR due to confounding are not mistakenly ascribed

  13. Health facility-based malaria surveillance: The effects of age, area of residence and diagnostics on test positivity rates

    PubMed Central

    2012-01-01

    Background The malaria test positivity rate (TPR) is increasingly used as an indicator of malaria morbidity because TPR is based on laboratory-confirmed cases and is simple to incorporate into existing surveillance systems. However, temporal trends in TPR may reflect changes in factors associated with malaria rather than true changes in malaria morbidity. This study examines the effects of age, area of residence and diagnostic test on TPR at two health facilities in regions of Uganda with differing malaria endemicity. Methods The analysis included data from diagnostic blood smears performed at health facilities in Walukuba and Aduku between January 2009 and December 2010. The associations between age and time and between age and TPR were evaluated independently to determine the potential for age to confound temporal trends in TPR. Subsequently, differences between observed TPR and TPR adjusted for age were compared to determine if confounding was present. A similar analysis was performed for area of residence. Temporal trends in observed TPR were compared to trends in TPR expected using rapid diagnostic tests, which were modelled based upon sensitivity and specificity in prior studies. Results Age was independently associated with both TPR and time at both sites. At Aduku, age-adjusted TPR increased relative to observed TPR due to the association between younger age and TPR and the gradual increase in age distribution. At Walukuba, there were no clear differences between observed and age-adjusted TPR. Area of residence was independently associated with both TPR and time at both sites, though there were no clear differences in temporal trends in area of residence-adjusted TPR and observed TPR at either site. Expected TPR with pLDH- and HRP-2-based rapid diagnostic tests (RDTs) was higher than observed TPR at all time points at both sites. Conclusions Adjusting for potential confounders such as age and area of residence can ensure that temporal trends in TPR due to

  14. Aspects of kit validation for tests used for the diagnosis and surveillance of livestock diseases: producer and end-user responsibilities.

    PubMed

    Crowther, J R; Unger, H; Viljoen, G J

    2006-12-01

    The Joint Food and Agriculture Organization/International Atomic Energy Agency (IAEA) Division of Nuclear Techniques in Food and Agriculture, based at the IAEA in Vienna, Austria, has extensive experience in helping to develop and validate assays and has provided strong support in developing World Organisation for Animal Health (OIE) norms. This paper will focus on enzyme-linked immunosorbent assay and polymerase chain reaction as the major technologies exploited in diagnosis and surveillance. Problems involving the terminology and factors in kit production, supply and validation are examined, in particular emphasising the importance of robustness and ruggedness of tests. The authors discuss the responsibilities of the various stakeholders (producers, distributors, users, and national/international organisations) in achieving quality controlled data to solve diagnostic and surveillance problems. The roles of internal quality control (internal proficiency testing) and external quality assurance (external proficiency testing) as well as aids to solving problems with kits are examined.

  15. State of play in direct-to-consumer genetic testing for lifestyle-related diseases: market, marketing content, user experiences and regulation.

    PubMed

    Saukko, Paula

    2013-02-01

    Direct-to-consumer (DTC) genetic tests have aroused controversy. Critics have argued many of the tests are not backed by scientific evidence, misguide their customers and should be regulated more stringently. Proponents suggest that finding out genetic susceptibilities for diseases could encourage healthier behaviours and makes the results of genetics research available to the public. This paper reviews the state of play in DTC genetic testing, focusing on tests identifying susceptibilities for lifestyle-related diseases. It will start with mapping the market for the tests. The paper will review (1) research on the content of the online marketing of DTC tests, (2) studies on the effects of DTC genetic tests on customers and (3) academic and policy proposals on how to regulate the tests. Current studies suggest that the marketing of DTC genetic tests often exaggerates their predictive powers, which could misguide consumers. However, research indicates that the tests do not seem to have major negative effects (worry and confusion) but neither do they engender positive effects (lifestyle change) on current users. Research on regulation of the tests has most commonly suggested regulating the marketing claims of the companies. In conclusion, the risks and benefits of DTC genetic tests are less significant than what has been predicted by critics and proponents, which will be argued reflects broader historical trends transforming health and medicine.

  16. Quality of information accompanying on-line marketing of home diagnostic tests

    PubMed Central

    Datta, Adrija K; Selman, Tara J; Kwok, Tony; Tang, Teresa; Khan, Khalid S

    2008-01-01

    Objective To assess the quality of information provided to consumers by websites marketing medical home diagnostic tests. Design A cross-sectional analysis of a database developed from searching targeted websites. Setting Data sources were websites written in English which marketed medical home diagnostic tests. Main outcome measures A meta-search engine was used to identify the first 20 citations for each type of home diagnostic medical test. Relevant websites limited to those written in English were reviewed independently and in triplicate, with disputes resolved by two further reviewers. Information on the quality of these sites was extracted using a pre-piloted performer. Results 168 websites were suitable for inclusion in the review. The quality of these sites showed marked variation. Only 24 of 168 (14.2%) complied with at least three-quarters of the quality items and just over half (95 of 168, 56.5%) reported official approval or certification of the test. Information on accuracy of the test marketed was reported by 87 of 168 (51.7%) websites, with 15 of 168 (8.9%) providing a scientific reference. Instructions for use of the product were found in 97 of 168 (57.9%). However, the course of action to be taken after obtaining the test result was stated in only 63 of 168 (37.5%) for a positive result and 43 of 168 (25.5%) for a negative result. Conclusions The quality of information posted on commercial websites marketing home tests online is unsatisfactory and potentially misleading for consumers. PMID:18263912

  17. Testing for contagion under asymmetric dynamics: Evidence from the stock markets between US and Taiwan

    NASA Astrophysics Data System (ADS)

    Wang, Kuan-Min; Nguyen Thi, Thanh-Binh

    2007-03-01

    This article is an attempt to test, through the use of forward forecasting test on dynamic conditional correlation (DCC), for contagion between Taiwan and US stocks under asymmetry. The process includes three steps. The first step uses the iterated cumulative sums of squares (ICSS) algorithm to detect the structural breaks of market return. The second step creates dummy variables for breaks, estimates EGARCH model of conditional generalized error distribution, and computes dynamic conditional correlation coefficients of DCC multivariate GARCH model. The third step employs one-step and N-step forecast test to check for contagion effect. The evidences prove the asymmetric leverage effect of Taiwan weighted stock index and New York-NYSE Composite Index. Interestingly, we discovered that there are two kinds of contagion, “positive” and “negative”, between markets.

  18. Discrimination of tenants with a visual impairment on the housing market: Empirical evidence from correspondence tests.

    PubMed

    Verhaeghe, Pieter-Paul; Van der Bracht, Koen; Van de Putte, Bart

    2016-04-01

    According to the social model of disability, physical 'impairments' become disabilities through exclusion in social relations. An obvious form of social exclusion might be discrimination, for instance on the rental housing market. Although discrimination has detrimental health effects, very few studies have examined discrimination of people with a visual impairment. We aim to study (1) the extent of discrimination of individuals with a visual impairment on the rental housing market and (2) differences in rates of discrimination between landowners and real estate agents. We conducted correspondence tests among 268 properties on the Belgian rental housing market. Using matched tests, we compared reactions by realtors and landowners to tenants with and tenants without a visual impairment. The results show that individuals with a visual impairment are substantially discriminated against in the rental housing market: at least one in three lessors discriminate against individuals with a visual impairment. We further discern differences in the propensity toward discrimination according to the type of lessor. Private landlords are at least twice as likely to discriminate against tenants with a visual impairment than real estate agents. At the same time, realtors still discriminate against one in five tenants with a visual impairment. This study shows the substantial discrimination against visually people with an impairment. Given the important consequences discrimination might have for physical and mental health, further research into this topic is needed. Copyright © 2016 Elsevier Inc. All rights reserved.

  19. Infection with Pathogens Transmitted Commonly Through Food and the Effect of Increasing Use of Culture-Independent Diagnostic Tests on Surveillance--Foodborne Diseases Active Surveillance Network, 10 U.S. Sites, 2012-2015.

    PubMed

    Huang, Jennifer Y; Henao, Olga L; Griffin, Patricia M; Vugia, Duc J; Cronquist, Alicia B; Hurd, Sharon; Tobin-D'Angelo, Melissa; Ryan, Patricia; Smith, Kirk; Lathrop, Sarah; Zansky, Shelley; Cieslak, Paul R; Dunn, John; Holt, Kristin G; Wolpert, Beverly J; Patrick, Mary E

    2016-04-15

    To evaluate progress toward prevention of enteric and foodborne illnesses in the United States, the Foodborne Diseases Active Surveillance Network (FoodNet) monitors the incidence of laboratory-confirmed infections caused by nine pathogens transmitted commonly through food in 10 U.S. sites. This report summarizes preliminary 2015 data and describes trends since 2012. In 2015, FoodNet reported 20,107 confirmed cases (defined as culture-confirmed bacterial infections and laboratory-confirmed parasitic infections), 4,531 hospitalizations, and 77 deaths. FoodNet also received reports of 3,112 positive culture-independent diagnostic tests (CIDTs) without culture-confirmation, a number that has markedly increased since 2012. Diagnostic testing practices for enteric pathogens are rapidly moving away from culture-based methods. The continued shift from culture-based methods to CIDTs that do not produce the isolates needed to distinguish between strains and subtypes affects the interpretation of public health surveillance data and ability to monitor progress toward prevention efforts. Expanded case definitions and strategies for obtaining bacterial isolates are crucial during this transition period.

  20. The World Health Organization Recommendations for Trachoma Surveillance, Experience in Nepal and Added Benefit of Testing for Antibodies to Chlamydia trachomatis pgp3 Protein: NESTS Study

    PubMed Central

    Zambrano, Andrea I.; Sharma, Shekhar; Crowley, Kathryn; Dize, Laura; Muñoz, Beatriz E.; Mishra, Sailesh K.; Rotondo, Lisa A.; Gaydos, Charlotte A.; West, Sheila K.

    2016-01-01

    Background The World Health Organization (WHO) now requires a second surveillance survey for trachoma after an impact assessment has found follicular trachoma (TF) <5% to determine if re-emergence has occurred. Using new WHO guidelines, we undertook surveillance surveys, and determined the prevalence of infection and antibody positivity, in two districts in Nepal. Methods 20 clusters were randomly selected within each district, 15 were randomly selected for antibody testing. In each cluster, we randomly selected 50 children ages 1–9 years and 100 adults ≥15 years. TF and trachomatous trichiasis (TT) were evaluated. Conjunctival swabs to test for chlamydial infection using GenXpert platform were obtained, and dried blood spots were collected to test for antibodies to Chlamydia Trachomatis pgp3 using the Luminex platform. Findings 3 cases of TF were found in the two districts, and one case of infection. Pgp3 antibody positivity was 2·4% (95% confidence interval: 1·4%, 3·7%), and did not increase with age (P = 0.24). No clustering of antibody positivity within communities was found. TT prevalence was <1/1,000 population. Interpretation The surveillance surveys, as proposed by WHO, showed no evidence for re-emergence of trachoma in two districts of Nepal. The low level and no significant increase by age in seroprevalence of antibodies to C trachomatis pgp3 antigen deserve further investigation as a marker of interruption of transmission. PMID:27654497

  1. Receptivity to Taboka and Camel Snus in a U.S. test market.

    PubMed

    Biener, Lois; Bogen, Karen

    2009-10-01

    The two largest U.S. cigarette manufacturers introduced Swedish-style low-nitrosamine smokeless tobacco (snus) to several U.S. test markets in summer 2006. Since then, snus brands and test markets have proliferated. This article assesses consumer response by analyzing data from the 2006 and 2007 Indiana Adult Tobacco Survey (IATS), a statewide telephone survey of 3,544 adults. During those years, the IATS included questions on awareness and trial of Camel Snus and Taboka. Analyses examined rates and predictors of awareness and trial statewide, and within the central Indiana test market. Nineteen percent of Indiana adults were aware of either Taboka or Camel Snus in 2006 and 2007. Estimates are larger (29%) for central Indiana and larger still (70%) for central Indiana smokers. Trial of snus, however, was very low (1.5% statewide), except among male smokers in central Indiana, 20% of whom are estimated to have tried it. Multivariate analyses showed that trial was more likely among men than women (odds ratio [OR] 13.85), residents of central Indiana than those farther from Indianapolis (OR 2.96), recipients than nonrecipients of tobacco promotions (OR 6.08), and those believing that smokeless tobacco is less harmful than cigarettes compared with those who believe it is equally or more harmful (OR 3.86). Results from this study suggest substantial initial interest in the new products among male smokers in this test market, especially those who receive promotional mailings from tobacco companies, which often include coupons for free or discounted products.

  2. Audit of Helicobacter pylori Testing in Microbiology Laboratories in England: To Inform Compliance with NICE Guidance and the Feasibility of Routine Antimicrobial Resistance Surveillance

    PubMed Central

    Allison, Rosalie; Lecky, Donna M.; Bull, Megan; Turner, Kim; Godbole, Gauri

    2016-01-01

    Introduction. The National Institute for Health and Clinical Excellence (NICE) guidance recommends that dyspeptic patients are tested for Helicobacter pylori using a urea breath test, stool antigen test, or serology. Antibiotic resistance in H. pylori is globally increasing, but treatment in England is rarely guided by susceptibility testing or surveillance. Aims. To determine compliance of microbiology laboratories in England with NICE guidance and whether laboratories perform culture and antibiotic susceptibility testing (AST). Methods. In 2015, 170 accredited English microbiology laboratories were surveyed, by email. Results. 121/170 (71%) laboratories responded; 96% provided H. pylori testing (78% on site). 94% provided H. pylori diagnosis using stool antigen; only four provided serology as their noninvasive test; 3/4 of these encouraged urea breath tests in their acute trusts. Only 22/94 (23%) of the laboratories performed H. pylori cultures from gastric biopsies on site; 9/22 performed AST, but the vast majority processed less than one specimen/week. Conclusions. Only five laboratories in England do not comply with NICE guidance; these will need the guidance reinforced. National surveillance needs to be implemented; culture-based AST would need to be centralised. Moving forward, detection of resistance in H. pylori from stool specimens using molecular methods (PCR) needs to be explored. PMID:27829836

  3. The malaria testing and treatment market in Kinshasa, Democratic Republic of the Congo, 2013.

    PubMed

    Mpanya, Godéfroid; Tshefu, Antoinette; Likwela, Joris Losimba

    2017-02-28

    The Democratic Republic of Congo (DRC) is one of the two most leading contributors to the global burden of disease due to malaria. This paper describes the malaria testing and treatment market in the nation's capital province of Kinshasa, including availability of malaria testing and treatment and relative anti-malarial market share for the public and private sector. A malaria medicine outlet survey was conducted in Kinshasa province in 2013. Stratified multi-staged sampling was used to select areas for the survey. Within sampled areas, all outlets with the potential to sell or distribute anti-malarials in the public and private sector were screened for eligibility. Among outlets with anti-malarials or malaria rapid diagnostic tests (RDT) in stock, a full audit of all available products was conducted. Information collected included product information (e.g. active ingredients, brand name), amount reportedly distributed to patients in the past week, and retail price. In total, 3364 outlets were screened for inclusion across Kinshasa and 1118 outlets were eligible for the study. Among all screened outlets in the private sector only about one in ten (12.1%) were stocking quality-assured Artemisinin-based Combination Therapy (ACT) medicines. Among all screened public sector facilities, 24.5% had both confirmatory testing and quality-assured ACT available, and 20.2% had sulfadoxine-pyrimethamine (SP) available for intermittent preventive therapy during pregnancy (IPTp). The private sector distributed the majority of anti-malarials in Kinshasa (96.7%), typically through drug stores (89.1% of the total anti-malarial market). Non-artemisinin therapies were the most commonly distributed anti-malarial (50.1% of the total market), followed by non quality-assured ACT medicines (38.5%). The median price of an adult quality-assured ACT was $6.59, and more expensive than non quality-assured ACT ($3.71) and SP ($0.44). Confirmatory testing was largely not available in the private

  4. Towards detection of pipeline integrity threats using a smart fiber optic surveillance system: PIT-STOP project blind field test results

    NASA Astrophysics Data System (ADS)

    Tejedor, J.; Macias-Guarasa, J.; Martins, H. F.; Piote, D.; Pastor-Graells, J.; Martin-Lopez, S.; Corredera, P.; De Pauw, G.; De Smet, F.; Postvoll, W.; Ahlen, C. H.; Gonzalez-Herraez, M.

    2017-04-01

    This paper presents the first report on on-line and final blind field test results of a pipeline integrity threat surveillance system. The system integrates a machine+activity identification mode, and a threat detection mode. Two different pipeline sections were selected for the blind tests: One close to the sensor position, and the other 35 km away from it. Results of the machine+activity identification mode showed that about 46% of the times the machine, the activity or both were correctly identified. For the threat detection mode, 8 out of 10 threats were correctly detected, with 1 false alarm.

  5. Laboratory Diagnostics Market in East Africa: A Survey of Test Types, Test Availability, and Test Prices in Kampala, Uganda.

    PubMed

    Schroeder, Lee F; Elbireer, Ali; Jackson, J Brooks; Amukele, Timothy K

    2015-01-01

    Diagnostic laboratory tests are routinely defined in terms of their sensitivity, specificity, and ease of use. But the actual clinical impact of a diagnostic test also depends on its availability and price. This is especially true in resource-limited settings such as sub-Saharan Africa. We present a first-of-its-kind report of diagnostic test types, availability, and prices in Kampala, Uganda. Test types (identity) and availability were based on menus and volumes obtained from clinical laboratories in late 2011 in Kampala using a standard questionnaire. As a measure of test availability, we used the Availability Index (AI). AI is the combined daily testing volumes of laboratories offering a given test, divided by the combined daily testing volumes of all laboratories in Kampala. Test prices were based on a sampling of prices collected in person and via telephone surveys in 2015. Test volumes and menus were obtained for 95% (907/954) of laboratories in Kampala city. These 907 laboratories offered 100 different test types. The ten most commonly offered tests in decreasing order were Malaria, HCG, HIV serology, Syphilis, Typhoid, Urinalysis, Brucellosis, Stool Analysis, Glucose, and ABO/Rh. In terms of AI, the 100 tests clustered into three groups: high (12 tests), moderate (33 tests), and minimal (55 tests) availability. 50% and 36% of overall availability was provided through private and public laboratories, respectively. Point-of-care laboratories contributed 35% to the AI of high availability tests, but only 6% to the AI of the other tests. The mean price of the most commonly offered test types was $2.62 (range $1.83-$3.46). One hundred different laboratory test types were in use in Kampala in late 2011. Both public and private laboratories were critical to test availability. The tests offered in point-of-care laboratories tended to be the most available tests. Prices of the most common tests ranged from $1.83-$3.46.

  6. Evaluating online direct-to-consumer marketing of genetic tests: informed choices or buyers beware?

    PubMed

    Geransar, Rose; Einsiedel, Edna

    2008-03-01

    Commercialization of genetic technologies is expanding the horizons for the marketing and sales of genetic tests direct-to-consumers (DTCs). This study assesses the information provision and access requirements that are in place for genetic tests that are being advertised DTC over the Internet. Sets of key words specific to DTC genetic testing were entered into popular Internet search engines to generate a list of 24 companies engaging in DTC advertising. Company requirements for physician mediation, genetic counseling arrangements, and information provision were coded to develop categories for quantitative analysis within each variable. Results showed that companies offering risk assessment and diagnostic testing were most likely to require that testing be mediated by a clinician, and to recommend physician-arranged counseling. Companies offering enhancement testing were less likely to require physician mediation of services and more likely to provide long-distance genetic counseling. DTC advertisements often provided information on disease etiology; this was most common in the case of multifactorial diseases. The majority of companies cited outside sources to support the validity of claims about clinical utility of the tests being advertised; companies offering risk assessment tests most frequently cited all information sources. DTC advertising for genetic tests that lack independent professional oversight raises troubling questions about appropriate use and interpretation of these tests by consumers and carries implications for the standards of patient care. These implications are discussed in the context of a public healthcare system.

  7. The marketing of health products, with special reference to do-it-yourself tests.

    PubMed

    Gevers, Sjef

    2003-01-01

    At a rapid pace, in vitro diagnostic medical devices are being developed to detect risk factors for disease; to a growing extent, these test kits are also directly marketed to the public for use at home. While at first sight serving a good cause, self testing may have considerable drawbacks relating to the well-being of the test subject on the one hand, and to the privacy and the right not to know of other persons on the other. This raises the question whether the availability of self tests should be restricted. Taking into account legal developments in The Netherlands and the European Union, the author argues in favour of restrictions, at least when serious diseases or conditions are concerned. The existence of the internet is not an excuse for not adopting such safeguards.

  8. Support for hospital-based HIV testing and counseling: a national survey of hospital marketing executives.

    PubMed Central

    Boscarino, J A; Steiber, S R

    1995-01-01

    Today, hospitals are involved extensively in social marketing and promotional activities. Recently, investigators from the Centers for Disease Control and Prevention (CDC) estimated that routine testing of hospital patients for human immunodeficiency virus (HIV) could identify more than 100,000 patients with previously unrecognized HIV infections. Several issues are assessed in this paper. These include hospital support for voluntary HIV testing and AIDS education and the impact that treating AIDS patients has on the hospital's image. Also tested is the hypothesis that certain hospitals, such as for-profit institutions and those outside the AIDS epicenters, would be less supportive of hospital-based AIDS intervention strategies. To assess these issues, a national random sample of 193 executives in charge of hospital marketing and public relations were surveyed between December 1992 and January 1993. The survey was part of an ongoing annual survey of hospitals and included questions about AIDS, health education, marketing, patient satisfaction, and hospital planning. Altogether, 12.4 percent of executives indicated their hospital had a reputation for treating AIDS patients. Among hospitals without an AIDS reputation, 34.1 percent believed developing one would be harmful to the hospital's image, in contrast to none in hospitals that had such a reputation (chi 2 = 11.676, df = 1, P = .0006). Although 16.6 percent did not know if large-scale HIV testing should be implemented, a near majority (47.7 percent) expressed some support. In addition, 15 percent reported that HIV-positive physicians on the hospital's medical staff should not be allowed to practice medicine, but 32.1 percent indicated that they should.(ABSTRACT TRUNCATED AT 250 WORDS) PMID:7638335

  9. Test Market Media Relations as a Pilot Test Component in a Nationwide Class Action Settlement Distribution.

    ERIC Educational Resources Information Center

    Pellecchia, Michael

    Results of a pilot test for a public relations campaign to assist in the distribution of funds from the settlement of a nationwide class action suit brought by tenants against the Department of Housing and Urban Development (HUD) are presented in this report. The first chapter presents the background of the case, noting that tenants of Section 236…

  10. Laboratory Diagnostics Market in East Africa: A Survey of Test Types, Test Availability, and Test Prices in Kampala, Uganda

    PubMed Central

    Schroeder, Lee F.; Elbireer, Ali; Jackson, J. Brooks; Amukele, Timothy K.

    2015-01-01

    Background Diagnostic laboratory tests are routinely defined in terms of their sensitivity, specificity, and ease of use. But the actual clinical impact of a diagnostic test also depends on its availability and price. This is especially true in resource-limited settings such as sub-Saharan Africa. We present a first-of-its-kind report of diagnostic test types, availability, and prices in Kampala, Uganda. Methods Test types (identity) and availability were based on menus and volumes obtained from clinical laboratories in late 2011 in Kampala using a standard questionnaire. As a measure of test availability, we used the Availability Index (AI). AI is the combined daily testing volumes of laboratories offering a given test, divided by the combined daily testing volumes of all laboratories in Kampala. Test prices were based on a sampling of prices collected in person and via telephone surveys in 2015. Findings Test volumes and menus were obtained for 95% (907/954) of laboratories in Kampala city. These 907 laboratories offered 100 different test types. The ten most commonly offered tests in decreasing order were Malaria, HCG, HIV serology, Syphilis, Typhoid, Urinalysis, Brucellosis, Stool Analysis, Glucose, and ABO/Rh. In terms of AI, the 100 tests clustered into three groups: high (12 tests), moderate (33 tests), and minimal (55 tests) availability. 50% and 36% of overall availability was provided through private and public laboratories, respectively. Point-of-care laboratories contributed 35% to the AI of high availability tests, but only 6% to the AI of the other tests. The mean price of the most commonly offered test types was $2.62 (range $1.83–$3.46). Interpretation One hundred different laboratory test types were in use in Kampala in late 2011. Both public and private laboratories were critical to test availability. The tests offered in point-of-care laboratories tended to be the most available tests. Prices of the most common tests ranged from $1

  11. Turing Trade: A Hybrid of a Turing Test and a Prediction Market

    NASA Astrophysics Data System (ADS)

    Farfel, Joseph; Conitzer, Vincent

    We present Turing Trade, a web-based game that is a hybrid of a Turing test and a prediction market. In this game, there is a mystery conversation partner, the “target,” who is trying to appear human, but may in reality be either a human or a bot. There are multiple judges (or “bettors”), who interrogate the target in order to assess whether it is a human or a bot. Throughout the interrogation, each bettor bets on the nature of the target by buying or selling human (or bot) securities, which pay out if the target is a human (bot). The resulting market price represents the bettors’ aggregate belief that the target is a human. This game offers multiple advantages over standard variants of the Turing test. Most significantly, our game gathers much more fine-grained data, since we obtain not only the judges’ final assessment of the target’s humanity, but rather the entire progression of their aggregate belief over time. This gives us the precise moments in conversations where the target’s response caused a significant shift in the aggregate belief, indicating that the response was decidedly human or unhuman. An additional benefit is that (we believe) the game is more enjoyable to participants than a standard Turing test. This is important because otherwise, we will fail to collect significant amounts of data. In this paper, we describe in detail how Turing Trade works, exhibit some example logs, and analyze how well Turing Trade functions as a prediction market by studying the calibration and sharpness of its forecasts (from real user data).

  12. Testing the stability of the 2000 US stock market “antibubble”

    NASA Astrophysics Data System (ADS)

    Zhou, Wei-Xing; Sornette, Didier

    2005-03-01

    Since August 2000, the stock market in the USA as well as most other western markets have depreciated almost in synchrony according to complex patterns of drops and local rebounds. In (Quantitative Finance 2 (2002) 468), we have proposed to describe this phenomenon using the concept of a log-periodic power law antibubble, characterizing behavioral herding between investors leading to a competition between positive and negative feedbacks in the pricing process. A monthly prediction for the future evolution of the US S&P 500 index has been issued, monitored and updated in ( http://www.ess.ucla.edu/faculty/sornette/prediction/index.asp#prediction), which is still running as the article goes to press. Here, we test the possible existence of a regime switching in the US S&P 500 antibubble. First, we find some evidence that the antibubble has exhibited a transition in log-periodicity described by a so-called second-order log-periodicity. Second, we develop a battery of tests to detect a possible end of the antibubble of the first order which suggest that the antibubble was alive in August 2003 but has ended in the USA, when expressed in the local US dollar currency. Our tests provide quantitative measures to diagnose the end of an antibubble. Such diagnostic is not instantaneous and requires from three to six months within the new regime before assessing its existence with confidence. From the perspective of foreign investors in their currencies (S&P 500 denominated in British pound or in euro) or when expressed in gold so as to correct for an arguably artificial US$ valuation associated with the Federal Reserve interest rate and monetary policy, we find that the S&P 500 antibubble is still alive and running its course. Similar analyses performed on the major European stock markets (CAC 40 of France, DAX of Germany, and FTSE 100 of United Kingdom) show that the antibubble is also present and continuing there.

  13. Evaluation of market samples of 'Yashada bhasma' using 'Namburi Phased Spot Test'.

    PubMed

    Bhojashettar, Santhosh; Poornima, B T; Jadar, P G

    2011-04-01

    Yashada bhasma (Calx of Yashada i.e. Zinc) which has its main indication in Prameha (Diabetes) and Netra vikaras (Eye disorders) was prepared according to the prescription in the Ayurvedic classics and subjected to various bhasma parikshas, including the Namburi Phased Spot Test (NPST), one of the qualitative tests described for various Ayurvedic preparations. NPST helps differentiate between, and thus identify, various bhasmas. It depends upon the pattern of the spot, which develops after a specific chemical reaction. Three market samples of Yashada bhasma, which were said to be Parada marita (incinerated using Mercury), were also subjected to the above tests and results compared. The various bhasmas exhibited marked differences in colour, and though NPST yielded desired results for all the samples, there were differences in their spot patterns and colour. The bhasma prepared in our department produced the most accurate results.

  14. [Direct-to-consumer genetic testing through Internet: marketing, ethical and social issues].

    PubMed

    Ducournau, Pascal; Gourraud, Pierre-Antoine; Rial-Sebbag, Emmanuelle; Bulle, Alexandre; Cambon-Thomsen, Anne

    2011-01-01

    We probably did not anticipate all the consequences of the direct to consumer genetic tests on Internet, resulting from the combined skills of communication and genomic advances. What are the commercial strategies used by the companies offering direct-to-consumer genetic tests on Internet and what are the different social expectations on which they focus? Through a quantitative and qualitative analysis of the web sites offering such tests, it seems that these companies target a triple market based on: the "healthism" which raises health and hygiene to the top of the social values; the contemporary demands of the users to become actual actors of health decisions; and finally on the need for bio-social relationships. These three commercial strategies underlie various ethical and societal issues justifying a general analysis.

  15. Validity of urinary monoamine assay sales under the "spot baseline urinary neurotransmitter testing marketing model".

    PubMed

    Hinz, Marty; Stein, Alvin; Uncini, Thomas

    2011-01-01

    Spot baseline urinary monoamine assays have been used in medicine for over 50 years as a screening test for monoamine-secreting tumors, such as pheochromocytoma and carcinoid syndrome. In these disease states, when the result of a spot baseline monoamine assay is above the specific value set by the laboratory, it is an indication to obtain a 24-hour urine sample to make a definitive diagnosis. There are no defined applications where spot baseline urinary monoamine assays can be used to diagnose disease or other states directly. No peer-reviewed published original research exists which demonstrates that these assays are valid in the treatment of individual patients in the clinical setting. Since 2001, urinary monoamine assay sales have been promoted for numerous applications under the "spot baseline urinary neurotransmitter testing marketing model". There is no published peer-reviewed original research that defines the scientific foundation upon which the claims for these assays are made. On the contrary, several articles have been published that discredit various aspects of the model. To fill the void, this manuscript is a comprehensive review of the scientific foundation and claims put forth by laboratories selling urinary monoamine assays under the spot baseline urinary neurotransmitter testing marketing model.

  16. MediCaring: development and test marketing of a supportive care benefit for older people.

    PubMed

    Lynn, J; O'Connor, M A; Dulac, J D; Roach, M J; Ross, C S; Wasson, J H

    1999-09-01

    To develop an alternative healthcare benefit (called MediCaring) and to assess the preferences of older Medicare beneficiaries concerning this benefit, which emphasizes more home-based and supportive health care and discourages use of hospitalization and aggressive treatment. To evaluate the beneficiaries' ability to understand and make a choice regarding health insurance benefits; to measure their likelihood to change from traditional Medicare to the new MediCaring benefit; and to determine the short-term stability of that choice. Focus groups of persons aged 65+ and family members shaped the potential MediCaring benefit. A panel of 50 national experts critiqued three iterations of the benefit. The final version was test marketed by discussing it with 382 older people (men > or = 75 years and women > or = 80 years) in their homes. Telephone surveys a few days later, and again 1 month after the home interview, assessed the potential beneficiaries' understanding and preferences concerning MediCaring and the stability of their responses. Focus groups were held in community settings in New Hampshire, Washington, DC, Cleveland, OH, and Columbia, SC. Test marketing occurred in New Hampshire, Cleveland, OH; Columbia, SC, and Los Angeles, CA. Focus group participants were persons more than 65 years old (11 focus groups), healthcare providers (9 focus groups), and family decision-makers (3 focus groups). Participants in the in-home informing (test marketing group) were persons older than 75 years who were identified through contact with a variety of services. Demographics, health characteristics, understanding, and preferences. Focus group beneficiaries between the ages of 65 and 74 generally wanted access to all possible medical treatment and saw MediCaring as a need of persons older than themselves. Those older than age 80 were mostly in favor of it. Test marketing participants understood the key points of the new benefit: 74% generally liked it, and 34% said they would

  17. 17 CFR 38.605 - Requirements for financial surveillance program.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 17 Commodity and Securities Exchanges 1 2013-04-01 2013-04-01 false Requirements for financial surveillance program. 38.605 Section 38.605 Commodity and Securities Exchanges COMMODITY FUTURES TRADING... financial surveillance program. A designated contract market's financial surveillance program for futures...

  18. 17 CFR 38.605 - Requirements for financial surveillance program.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 17 Commodity and Securities Exchanges 1 2014-04-01 2014-04-01 false Requirements for financial surveillance program. 38.605 Section 38.605 Commodity and Securities Exchanges COMMODITY FUTURES TRADING... financial surveillance program. A designated contract market's financial surveillance program for futures...

  19. 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.

  20. 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.

  1. 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.

  2. 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.

  3. [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.

  4. Diagnostics and surveillance methods

    USDA-ARS?s Scientific Manuscript database

    Detection and diagnosis of influenza A virus (IAV) infection in animals requires a laboratory test since disease from IAV presents no pathognomonic signs. Diagnosis and surveillance of animal influenza focuses on the detection of virus or type specific antibodies. Whether one targets the virus or ...

  5. Prevention of malaria in Afghanistan through social marketing of insecticide-treated nets: evaluation of coverage and effectiveness by cross-sectional surveys and passive surveillance.

    PubMed

    Rowland, Mark; Webster, Jayne; Saleh, Padshah; Chandramohan, Daniel; Freeman, Tim; Pearcy, Barbara; Durrani, Naeem; Rab, Abdur; Mohammed, Nasir

    2002-10-01

    Malaria is often a major health problem in countries undergoing war or conflict owing to breakdown of health systems, displacement of vulnerable populations, and the increased risk of epidemics. After 23 years of conflict, malaria has become prevalent in many rural areas of Afghanistan. From 1993 to the present, a network of non-governmental organizations, co-ordinated by HealthNet International, has operated a programme of bednet sales and re-treatment in lowland areas. To examine whether a strategy based on insecticide-treated nets (ITN) is a viable public health solution to malaria, communities were given the opportunity to buy nets and then monitored to determine population coverage and disease control impact. This was carried out using two contrasting methods: cross-sectional surveys and passive surveillance from clinics using a case-control design. Nets were purchased by 59% of families. Cross-sectional surveys demonstrated a 59% reduction in the risk of Plasmodium falciparum infection among ITN users compared with non-users (OR 0.41; 95% CI 0.25-0.66). The passive surveillance method showed a comparable reduction in the risk of symptomatic P. falciparum malaria among ITN users (OR 0.31; 95% CI 0.21-0.47). The cross-sectional method showed a 50% reduction in risk of P. vivax infection in ITN users compared with non-users (OR 0.50; 95% CI 0.17-1.49) but this effect was not statistically significant. The passive surveillance method showed a 25% reduction in the risk of symptomatic P. vivax malaria (OR 0.75; 95% CI 0.66-0.85). ITN appeared to be less effective against P. vivax because of relapsing infections; hence an effect took more than one season to become apparent. Passive surveillance was cheaper to perform and gave results consistent with cross-sectional surveys. Untreated nets provided some protection. Data on socioeconomic status, a potential confounding factor, was not collected. However, at the time of net sales, there was no difference in malaria

  6. Surveillance of Autism.

    ERIC Educational Resources Information Center

    Boyle, Coleen A.; Bertrand, Jacquelyn; Yeargin-Allsopp, Marshalyn

    1999-01-01

    This article describes the autism surveillance activities of the Center for Disease Control and Prevention. It considers why surveillance to track prevalence of autistic disorders is needed, how such surveillance is conducted, and the special challenges of autism surveillance. (DB)

  7. Surveillance of antibiotic resistance

    PubMed Central

    Johnson, Alan P.

    2015-01-01

    Surveillance involves the collection and analysis of data for the detection and monitoring of threats to public health. Surveillance should also inform as to the epidemiology of the threat and its burden in the population. A further key component of surveillance is the timely feedback of data to stakeholders with a view to generating action aimed at reducing or preventing the public health threat being monitored. Surveillance of antibiotic resistance involves the collection of antibiotic susceptibility test results undertaken by microbiology laboratories on bacteria isolated from clinical samples sent for investigation. Correlation of these data with demographic and clinical data for the patient populations from whom the pathogens were isolated gives insight into the underlying epidemiology and facilitates the formulation of rational interventions aimed at reducing the burden of resistance. This article describes a range of surveillance activities that have been undertaken in the UK over a number of years, together with current interventions being implemented. These activities are not only of national importance but form part of the international response to the global threat posed by antibiotic resistance. PMID:25918439

  8. Comparison of height, weight, and body mass index data from state-mandated school physical fitness testing and a districtwide surveillance project.

    PubMed

    Khaokham, Christina B; Hillidge, Sharon; Serpas, Shaila; McDonald, Eric; Nader, Philip R

    2015-05-01

    Approximately one third of California school-age children are overweight or obese. Legislative approaches to assessing obesity have focused on school-based data collection. During 2010-2011, the Chula Vista Elementary School District conducted districtwide surveillance and state-mandated physical fitness testing (PFT) among fifth grade students. We compared height, weight, and body mass index (BMI) to examine measurement differences between the projects. We assessed demographic characteristics and BMI category frequencies. We used paired t-tests to test continuous variables. κ statistics were used to assess categorical agreement. Of 3549 children assessed, 69% were Hispanic. Fifty-one percent were boys. Mean heights, weights, and BMIs were significantly different for each project (p < .0001). Surveillance height (106.7-165.1 cm) and weight (21.6-90.8 kg) ranges were lesser than PFT ranges (109.2-180.3 cm and 22.7-98.4 kg). The overall BMI category agreement was good (weighted κ = 0.77). Categorical percentage agreement was highest among normal weight children (94.9%) and lowest among underweight children (56.6%). Methodological differences might have resulted in the observed height, weight, and BMI differences. As school-based interventions become common, districts should carefully consider measurement reliability, training, and data-handling protocols to have confidence in their findings. © 2015, American School Health Association.

  9. 28 CFR 550.41 - Urine surveillance.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 28 Judicial Administration 2 2014-07-01 2014-07-01 false Urine surveillance. 550.41 Section 550.41... Drug Services (Urine Surveillance and Counseling for Sentenced Inmates in Contract CTCs) § 550.41 Urine surveillance. A program of urine testing for drug use shall be established in contract CTCs. (a)...

  10. 28 CFR 550.41 - Urine surveillance.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 28 Judicial Administration 2 2013-07-01 2013-07-01 false Urine surveillance. 550.41 Section 550.41... Drug Services (Urine Surveillance and Counseling for Sentenced Inmates in Contract CTCs) § 550.41 Urine surveillance. A program of urine testing for drug use shall be established in contract CTCs. (a)...

  11. 28 CFR 550.41 - Urine surveillance.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Urine surveillance. 550.41 Section 550.41... Drug Services (Urine Surveillance and Counseling for Sentenced Inmates in Contract CTCs) § 550.41 Urine surveillance. A program of urine testing for drug use shall be established in contract CTCs. (a)...

  12. 28 CFR 550.41 - Urine surveillance.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 28 Judicial Administration 2 2012-07-01 2012-07-01 false Urine surveillance. 550.41 Section 550.41... Drug Services (Urine Surveillance and Counseling for Sentenced Inmates in Contract CTCs) § 550.41 Urine surveillance. A program of urine testing for drug use shall be established in contract CTCs. (a)...

  13. 28 CFR 550.41 - Urine surveillance.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 28 Judicial Administration 2 2011-07-01 2011-07-01 false Urine surveillance. 550.41 Section 550.41... Drug Services (Urine Surveillance and Counseling for Sentenced Inmates in Contract CTCs) § 550.41 Urine surveillance. A program of urine testing for drug use shall be established in contract CTCs. (a)...

  14. Characterization of currently marketed heparin products: key tests for LMWH quality assurance.

    PubMed

    Ye, Hongping; Toby, Timothy K; Sommers, Cynthia D; Ghasriani, Houman; Trehy, Michael L; Ye, Wei; Kolinski, Richard E; Buhse, Lucinda F; Al-Hakim, Ali; Keire, David A

    2013-11-01

    During the 2007-2008 heparin crisis it was found that the United States Pharmacopeia (USP) testing monograph for heparin sodium or low molecular weight heparins did not detect the presence of the contaminant, oversulfated chondroitin sulfate (OSCS). In response to this concern, new tests and specifications were developed by the Food and Drug Administration (FDA) and USP and put in place to detect not only the contaminant OSCS, but also to improve assurance of quality and purity of these drug products. The USP monographs for the low molecular weight heparins (LMWHs) approved for use in the United States (dalteparin, tinzaparin and enoxaparin) are also undergoing revision to include many of the same tests used for heparin sodium, including; one-dimensional (1D) 500 MHz (1)H NMR, SAX-HPLC, percent galactosamine in total hexosamine and anticoagulation time assays with purified Factor IIa or Factor Xa. These tests represent orthogonal approaches for heparin identification, measurement of bioactivity and for detection of process impurities or contaminants in these drug products. Here we describe results from a survey of multiple lots from three types of LMWHs in the US market which were collected after the 2009 heparin sodium monograph revision. In addition, innovator and generic versions of formulated enoxaparin products purchased in 2011 are compared using these tests and found to be highly similar within the discriminating power of the assays applied.

  15. 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.

  16. Air surveillance

    SciTech Connect

    Patton, G.W.

    1995-06-01

    This section of the 1994 Hanford Site Environmental Report summarizes the air surveillance and monitoring programs currently in operation at that Hanford Site. Atmospheric releases of pollutants from Hanford to the surrounding region are a potential source of human exposure. For that reason, both radioactive and nonradioactive materials in air are monitored at a number of locations. The influence of Hanford emissions on local radionuclide concentrations was evaluated by comparing concentrations measured at distant locations within the region to concentrations measured at the Site perimeter. This section discusses sample collection, analytical methods, and the results of the Hanford air surveillance program. A complete listing of all analytical results summarized in this section is reported separately by Bisping (1995).

  17. Safety and effectiveness of tadalafil in pediatric patients with pulmonary arterial hypertension: a sub-group analysis based on Japan post-marketing surveillance.

    PubMed

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

    2017-07-20

    To evaluate the long-term safety and effectiveness of tadalafil in pediatric patients with pulmonary arterial hypertension (PAH) in real-world clinical practice. This is an observational surveillance of PAH patients receiving tadalafil in the contracted sites. A sub-group analysis was performed of 391 pediatric PAH patients (<18 years) who were included from 1,704 total patients in this surveillance. Safety was assessed from the frequency of adverse drug reactions (ADRs), discontinuations due to adverse events (AEs), and serious adverse drug reactions (SADRs). Effectiveness measurements included change in World Health Organization (WHO) functional classification of PAH, cardiac catheterization (pulmonary arterial pressure: PAP), and echocardiography (tricuspid regurgitation pressure gradient: TRPG). Survival rate was also measured. The mean patient age was 5.7 ± 5.34 years. Associated PAH (APAH) and idiopathic PAH (IPAH) accounted for 76.0% and 17.6%, respectively, of the PAH patients. Patients were followed for up to 2 years. Among 391 patients analyzed for safety, the overall incidence rate of ADRs was 16.6%. The common ADRs (≥ 1%) were headache (2.8%), hepatic function abnormal, platelet count decreased (1.3% each), and epistaxis, (1.0%). Eleven patients (2.8%) reported 16 SADRs. Three patients died secondary to SADRs. For the effectiveness analysis, the incidence of WHO functional class improvement at 3 months, 1 year, and 2 years after the initiation of tadalafil and last observation in pediatric patients were 16.5%, 19.7%, and 16.3%, respectively. Both PAP and TRPG showed a statistically significant reduction at last observation. This manuscript reveals the use of tadalafil in the real-world pediatric population with an acceptable safety profile in Japan.

  18. An MDI (Minimum Discrimination Information) Model and an Algorithm for Composite Hypotheses Testing and Estimation in Marketing. Revision 2.

    DTIC Science & Technology

    1982-09-01

    MARKETING * by A. Charnes W. W. Cooper *D. B. Learner*F. Y. Phillips* CENTER FOR CYBEI! NTIC STU[)IES The Universityof Texas Austin,Texas 78712 CM a a I 0...34,.. u.. 29 061. L1..<i’ I Research Report CCS 397 AN MDI MODEL AND AN ALGORITHM FOR COMPOSITE HYPOTHESES TESTING AND ESTIMATION IN MARKETING * by A...Charn~s W. V. Cooper D. E. Lea-nir* .. F. ".Philli,.)s* --. Original: July 1981 Revispd: September.1981.Second Revision: Septembr 1982 0, 0 gt’, * Market

  19. Surveillance of the frequency and results of testing of incident oropharyngeal cancers for human papillomavirus: the potential role of population-based cancer registries.

    PubMed

    Polednak, Anthony P; Phillips, Cathryn

    2014-01-01

    Temporal increases in incidence rates for certain cancers of the oropharynx (OP), especially the base of tongue and tonsil (BTT), have been interpreted in relation to the epidemic of human papillomavirus (HPV) infection, but data on the actual presence of HPV in these tumors are limited. Data on the frequency and results of testing for HPV in OP cancers in defined populations also can be useful to clinicians. This study used the American Joint Committee on Cancer Collaborative Staging System's Site-Specific Factor 10 (SSF 10) for HPV status of OP tumors, collected by some registries for diagnoses since 2010. The study included 483 incident invasive BTT cancers diagnosed in 2010-2012 and reported to the Connecticut Tumor Registry of the Surveillance, Epidemiology and End Results (SEER) Program. Of the 483 cancers, 45.8 percent were reportedly tested for HPV in tumor tissue; the proportion coded as unknown declined from 54.6 percent for 2010 to 34.3 percent for 2012. The 153 cases reported as HPV-positive comprised 69.2 percent of the 221 cases with a known HPV test result, which is consistent with the proportions reported in the literature. Trends (2000-2010) in BTT cancer incidence rates in Connecticut were representative of trends in all 18 SEER registries combined. Similar studies are needed from other US central cancer registries that are collecting or want to start collecting HPV status of OP tumors, along with data on the specific types of HPV testing, for surveillance of the frequency and results of HPV testing of OP cancers.

  20. Extended Result Reading Window in Lateral Flow Tests Detecting Exposure to Onchocerca volvulus: A New Technology to Improve Epidemiological Surveillance Tools

    PubMed Central

    Golden, Allison; Steel, Cathy; Yokobe, Lindsay; Jackson, Emily; Barney, Rebecca; Kubofcik, Joseph; Peck, Roger; Unnasch, Thomas R.; Nutman, Thomas B.; de los Santos, Tala; Domingo, Gonzalo J.

    2013-01-01

    Onchocerciasis is a neglected tropical disease caused by infection with the parasite Onchocerca volvulus (Ov). An estimated 180 million people are at risk for Ov infection, and 37 million people are infected, mostly in Africa. A lateral flow-based assay to detect human IgG4 antibodies to the Ov-specific antigen Ov-16 was developed as a rapid tool to detect exposure to Ov. The test, when performed on 449 sera specimens from patients with microfiladermia and Ov-negative patients, has a sensitivity of 89.1% (95% confidence interval: 86.2%–92.0%), and specificity of 97% (95% confidence interval: 95.4%–98.6%). Because the intended use of the test is for surveillance, it is highly desirable to have a stable, long-lasting result. An extended read window is thus desirable for a high-volume, busy workflow and facilitates post-surveillance quality assurance. The main restriction on achieving an extended read window for this assay was the erythrocyte lysis that can alter the signal-to-noise ratio, especially in those with low IgG4 levels (weak positives). We describe a test housing that incorporates a user-independent feature driven by assay fluid and an expanding wick that detaches the blood separation membrane from the nitrocellulose used in the assay, but before hemolysis occurs. We demonstrated material functionality at extreme operational conditions (37°C, 80% relative humidity) and a read window of a minimum of 70 days. The fluid-driven assay device performs equally as well with whole blood as with plasma, as demonstrated with 100 spiked clinical specimens (with a correlation coefficient of 0.96). We show a novel, inexpensive, and simple approach to actuating the detachment of the blood separation membrane from the nitrocellulose test with no impact on the performance characteristics of the test. PMID:23935960

  1. A study of correlations between crude oil spot and futures markets: A rolling sample test

    NASA Astrophysics Data System (ADS)

    Liu, Li; Wan, Jieqiu

    2011-10-01

    In this article, we investigate the asymmetries of exceedance correlations and cross-correlations between West Texas Intermediate (WTI) spot and futures markets. First, employing the test statistic proposed by Hong et al. [Asymmetries in stock returns: statistical tests and economic evaluation, Review of Financial Studies 20 (2007) 1547-1581], we find that the exceedance correlations were overall symmetric. However, the results from rolling windows show that some occasional events could induce the significant asymmetries of the exceedance correlations. Second, employing the test statistic proposed by Podobnik et al. [Quantifying cross-correlations using local and global detrending approaches, European Physics Journal B 71 (2009) 243-250], we find that the cross-correlations were significant even for large lagged orders. Using the detrended cross-correlation analysis proposed by Podobnik and Stanley [Detrended cross-correlation analysis: a new method for analyzing two nonstationary time series, Physics Review Letters 100 (2008) 084102], we find that the cross-correlations were weakly persistent and were stronger between spot and futures contract with larger maturity. Our results from rolling sample test also show the apparent effects of the exogenous events. Additionally, we have some relevant discussions on the obtained evidence.

  2. Factors Associated With Recent Human Immunodeficiency Virus Testing Among Men Who Have Sex With Men in Puerto Rico, National Human Immunodeficiency Virus Behavioral Surveillance System, 2011.

    PubMed

    Chapin-Bardales, Johanna; Sanchez, Travis; Paz-Bailey, Gabriela; Hageman, Kathy; Spiller, Michael W; Rolon-Colon, Yadira; Miranda de Leon, Sandra

    2016-06-01

    Annual human immunodeficiency virus (HIV) testing is considered a key strategy for HIV prevention for men who have sex with men (MSM). In Puerto Rico, HIV research has primarily focused on injection drug use, yet male-to-male sexual transmission has been increasing in recent years. Cross-sectional data from the National HIV Behavioral Surveillance system collected in 2011 in San Juan, Puerto Rico, were analyzed to identify factors associated with HIV testing in the past 12 months (recent testing). Overall, 50% of participants were tested recently. In the multivariate analysis, testing recently was associated with having multiple partners in the past 12 months (adjusted prevalence ratio [aPR] [≥4 vs 1 partner] = 1.5; 95% confidence interval [95% CI], 1.2-2.0), visiting a health care provider in the past 12 months (aPR, 1.4; 95% CI, 1.04-1.8), and disclosing male-male attraction/sex to a health care provider (aPR< 1.4; 95% CI, 1.1-1.7). Human immunodeficiency virus testing was suboptimal among MSM in San Juan. Strategies to increase HIV testing among MSM may include promoting HIV testing for all sexually active MSM including those with fewer partners, increasing utilization of the healthcare system, and improving patient-provider communication.

  3. Factors Associated With Recent Human Immunodeficiency Virus Testing Among Men Who Have Sex With Men in Puerto Rico, National Human Immunodeficiency Virus Behavioral Surveillance System, 2011

    PubMed Central

    Chapin-Bardales, Johanna; Sanchez, Travis; Paz-Bailey, Gabriela; Hageman, Kathy; Spiller, Michael W.; Rolon-Colon, Yadira; de Leon, Sandra Miranda

    2016-01-01

    Background Annual human immunodeficiency virus (HIV) testing is considered a key strategy for HIV prevention for men who have sex with men (MSM). In Puerto Rico, HIV research has primarily focused on injection drug use, yet male-to-male sexual transmission has been increasing in recent years. Methods Cross-sectional data from the National HIV Behavioral Surveillance system collected in 2011 in San Juan, Puerto Rico, were analyzed to identify factors associated with HIV testing in the past 12 months (recent testing). Results Overall, 50% of participants were tested recently. In the multivariate analysis, testing recently was associated with having multiple partners in the past 12 months (adjusted prevalence ratio [aPR] [≥4 vs 1 partner] = 1.5; 95% confidence interval [95% CI], 1.2–2.0), visiting a health care provider in the past 12 months (aPR, 1.4; 95% CI, 1.04–1.8), and disclosing male-male attraction/sex to a health care provider (aPR< 1.4; 95% CI, 1.1–1.7). Conclusions Human immunodeficiency virus testing was suboptimal among MSM in San Juan. Strategies to increase HIV testing among MSM may include promoting HIV testing for all sexually active MSM including those with fewer partners, increasing utilization of the healthcare system, and improving patient-provider communication. PMID:27200518

  4. Negotiating the boundary between medicine and consumer culture: online marketing of nutrigenetic tests.

    PubMed

    Saukko, Paula M; Reed, Matthew; Britten, Nicky; Hogarth, Stuart

    2010-03-01

    Genomics researchers and policy makers have accused nutrigenetic testing companies--which provide DNA-based nutritional advice online--of misleading the public. The UK and USA regulation of the tests has hinged on whether they are classed as "medical" devices, and alternative regulatory categories for "lifestyle" and less-serious genetic tests have been proposed. This article presents the findings of a qualitative thematic analysis of the webpages of nine nutrigenetic testing companies. We argue that the companies, mirroring and negotiating the regulatory debates, were creating a new social space for products between medicine and consumer culture. This space was articulated through three themes: (i) how "genes" and tests were framed, (ii) how the individual was imagined vis a vis health information, and (iii) the advice and treatments offered. The themes mapped onto four frames or models for genetic testing: (i) clinical genetics, (ii) medicine, (iii) intermediate, and (iv) lifestyle. We suggest that the genomics researchers and policy makers appeared to perform what Gieryn (Gieryn, T.F. (1983). Boundary-work and the demarcation of science from non-science: strains and interests in professional ideologies of scientists. American Sociological Review, 48, 781-795.) has termed "boundary work", i.e., to delegitimize the tests as outside proper medicine and science. Yet, they legitimated them, though in a different way, by defining them as lifestyle, and we contend that the transformation of the boundaries of science into a creation of such hybrid or compromise categories is symptomatic of current historical times. Social scientists studying medicine have referred to the emergence of "lifestyle" products. This article contributes to this literature by examining the historical, regulatory and marketing processes through which certain goods and services become defined this way.

  5. [Overregulation and unnecessary animal testing: requirements for market approval of biopharmaceuticals too rigid].

    PubMed

    Schellekens, Huub

    2012-01-01

    The first biopharmaceutical was introduced more than 30 years ago. From the beginning, experts have doubted the scientific basis for preclinical safety testing of these products on animals, including non-human primates. Long clinical experience confirms that this has no scientific basis. The many guidelines introduced over the years, including the recent revision of ICH S6, are still based on the principles of the classical safety evaluation of small molecules. The reasons for this conservatism include the risk-averse attitude of regulators in general and, at the European level, the low influx of new scientific insights due to the way the marketing authorisation is organised. The members of the scientific committees of the EMA are almost exclusively selected from within the regulatory systems and there is no limit in the time they can serve in these committees.

  6. A panel priority rating exercise for the British Forces Germany Health Services Market test.

    PubMed

    Jefferson, T O; Demicheli, V

    1995-02-01

    We report on the application to the BFG Health Services Market Testing (MT) study of the response to a users' questionnaire and panel discussions to determine in which priority and how services should be provided. The questionnaire served to inform lay and health care panel members on users' views on the relative importance of future health services and the way they will be provided. Based on the questionnaire results and data contained in the BAOR Report of Public Health for 1992/93 the panel assigned the highest priorities to emergency services, followed by routine General Practitioner services and essential hospital services. The lowest ranking were non-essential hospital services, health care for children with special needs and provision of designated transport. There was a high consistency in views between the lay and health care members of the panel.

  7. Effect of climatic conditions on epidemic patterns of influenza in Okinawa, Japan, during the pandemic of 2009: surveillance of rapid antigen test results.

    PubMed

    Iha, Yoshikazu; Higa, Futoshi; Sunagawa, Satoko; Naka, Masamitsu; Cash, Haley L; Miyagi, Kazuya; Haranaga, Shusaku; Tateyama, Masao; Uno, Tsukasa; Fujita, Jiro

    2012-07-01

    Climatic conditions may have affected the incidence of influenza during the pandemic of 2009 as well as at other times. This study evaluated the effects of climatic conditions on influenza incidence in Okinawa, a subtropical region in Japan, during the 2009 pandemic using surveillance data from rapid antigen test (RAT) results. Weekly RAT results performed in four acute care hospitals in the Naha region of the Okinawa Islands from January 2007 to July 2011 were anonymously collected for surveillance of regional influenza prevalence. Intense epidemic peaks were noted in August 2009 and December 2009-January 2010 during the influenza pandemic of 2009. RAT positivity rates were lower during the pandemic period than during the pre- and post-pandemic periods. Lower ambient temperature was associated with higher influenza incidence during pre- and post-pandemic periods but not during the pandemic of 2009. Lower relative humidity was associated with higher influenza incidence during the pandemic as well as during the other two periods. The association of climatic conditions and influenza incidence was less prominent during the pandemic of 2009 than during pre- and post-pandemic periods.

  8. Safety of ipragliflozin in elderly Japanese patients with type 2 diabetes mellitus (STELLA-ELDER): Interim results of a post-marketing surveillance study.

    PubMed

    Terauchi, Yasuo; Yokote, Koutaro; Nakamura, Ichiro; Sugamori, Haruko

    2016-01-01

    To determine the incidence of adverse drug reactions (ADRs) associated with ipragliflozin in elderly Japanese patients with type 2 diabetes mellitus. We report interim results of a postmarketing surveillance survey. Japanese physicians recorded ADRs in elderly patients (≥ 65 years old) who were first prescribed with ipragliflozin within 3 months of its launch (April 2014). Incidence of ADRs within 1 year of starting treatment with ipragliflozin. 898 ADRs occurred in 721/7,170 patients (10.06%). Skin complication-, volume depletion-, genital infection-, polyuria/pollakiuria-, urinary tract infection-, and hypoglycemia-related ADRs occurred in 2.23%, 1.90%, 1.45%, 1.32%, 0.77%, and 0.32%, respectively. ADRs were classified as serious in 44 (0.61%) patients. Half of the ADRs occurred within 30 days of starting treatment. There were no cases of Stevens-Johnson syndrome or toxic epidermal necrolysis. Most (92.1%) of the ADRs resolved or improved. Glycated hemoglobin, fasting blood glucose, body weight, and systolic blood pressure decreased by 0.6% (baseline 7.8%), 22.7 mg/dL (baseline 163.0 mg/dL), 2.3 kg (baseline 67.4 kg), and 3.1 mmHg (baseline 133.2 mmHg), respectively, from baseline to treatment discontinuation/last visit. Ipragliflozin is well tolerated and reduced surrogate endpoints in elderly Japanese patients with type 2 diabetes mellitus. Clinicaltrials.gov identifier: NCT02297620.

  9. Post-Marketing Surveillance of Human Rabies Diploid Cell Vaccine (Imovax) in the Vaccine Adverse Event Reporting System (VAERS) in the United States, 1990‒2015

    PubMed Central

    Moro, Pedro L.; Woo, Emily Jane; Paul, Wendy; Lewis, Paige; Petersen, Brett W.; Cano, Maria

    2016-01-01

    Background In 1980, human diploid cell vaccine (HDCV, Imovax Rabies, Sanofi Pasteur), was licensed for use in the United States. Objective To assess adverse events (AEs) after HDCV reported to the US Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system. Methods We searched VAERS for US reports after HDCV among persons vaccinated from January 1, 1990–July 31, 2015. Medical records were requested for reports classified as serious (death, hospitalization, prolonged hospitalization, disability, life-threatening-illness), and those suggesting anaphylaxis and Guillain-Barré syndrome (GBS). Physicians reviewed available information and assigned a primary clinical category to each report using MedDRA system organ classes. Empirical Bayesian (EB) data mining was used to identify disproportional AE reporting after HDCV. Results VAERS received 1,611 reports after HDCV; 93 (5.8%) were serious. Among all reports, the three most common AEs included pyrexia (18.2%), headache (17.9%), and nausea (16.5%). Among serious reports, four deaths appeared to be unrelated to vaccination. Conclusions This 25-year review of VAERS did not identify new or unexpected AEs after HDCV. The vast majority of AEs were non-serious. Injection site reactions, hypersensitivity reactions, and non-specific constitutional symptoms were most frequently reported, similar to findings in pre-licensure studies. PMID:27410239

  10. Patch test results with fragrance markers of the baseline series - analysis of the European Surveillance System on Contact Allergies (ESSCA) network 2009-2012.

    PubMed

    Frosch, Peter J; Duus Johansen, Jeanne; Schuttelaar, Marie-Louise A; Silvestre, Juan F; Sánchez-Pérez, Javier; Weisshaar, Elke; Uter, Wolfgang

    2015-09-01

    Contact allergy to fragrances is common, and impairs quality of life, particularly in young women. To provide current results on the prevalences of sensitization to fragrance allergens used as markers in the baseline series of most European countries. Data of patients consecutively patch tested between 2009 and 2012 in 12 European countries with fragrance allergens contained in the baseline series were collected by the European Surveillance System on Contact Allergies network and descriptively analysed. Four departments used the TRUE Test(®) system. The 'basic markers' were tested on 51 477 [fragrance mix II (FM II)] to 57 123 [Myroxylon pereirae, balsam of Peru] patients, and yielded positive reactions as follows: fragrance mix I 6.9%, Myroxylon pereirae 5.4%, FM II 3.8%, colophonium 2.6%, and hydroxyisohexyl 3-cyclohexene carboxaldehyde 1.7%, with some regional differences. Prevalences with TRUE Test(®) allergens were lower. Additional fragrances were tested on 3643 (trimethylbenzenepropanol) to 14 071 (oil of turpentine) patients, and yielded between 2.6% (Cananga odorata) and 0.7% (trimethylbenzenepropanol) positive reactions. Contact allergy to fragrances is common throughout Europe, with regional variation probably being explained by patch test technique, and differences in exposure and referral patterns. The current basic markers of fragrance sensitivity in the baseline series should be supplemented with additional fragrance allergens. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  11. Increases in HIV Testing among Men Who Have Sex with Men — National HIV Behavioral Surveillance System, 20 U.S. Metropolitan Statistical Areas, 2008 and 2011

    PubMed Central

    Cooley, Laura A.; Oster, Alexandra M.; Rose, Charles E.; Wejnert, Cyprian; Le, Binh C.; Paz-Bailey, Gabriela

    2014-01-01

    In 2011, 62% of estimated new HIV diagnoses in the United States were attributed to male-to-male sexual contact (men who have sex with men, MSM); 39% of these MSM were black or African American. HIV testing, recommended at least annually by CDC for sexually active MSM, is an essential first step in HIV care and treatment for HIV-positive individuals. A variety of HIV testing initiatives, designed to reach populations disproportionately affected by HIV, have been developed at both national and local levels. We assessed changes in HIV testing behavior among MSM participating in the National HIV Behavioral Surveillance System in 2008 and 2011. We compared the percentages tested in the previous 12 months in 2008 and 2011, overall and by race/ethnicity and age group. In unadjusted analyses, recent HIV testing increased from 63% in 2008 to 67% in 2011 overall (P<0.001), from 63% to 71% among black MSM (P<0.001), and from 63% to 75% among MSM of other/multiple races (P<0.001); testing did not increase significantly for white or Hispanic/Latino MSM. Multivariable model results indicated an overall increase in recent HIV testing (adjusted prevalence ratio [aPR] = 1.07, P<0.001). Increases were largest for black MSM (aPR = 1.12, P<0.001) and MSM of other/multiple races (aPR = 1.20, P<0.001). Among MSM aged 18–19 years, recent HIV testing was shown to increase significantly among black MSM (aPR = 1.20, P = 0.007), but not among MSM of other racial/ethnic groups. Increases in recent HIV testing among populations most affected by HIV are encouraging, but despite these increases, improved testing coverage is needed to meet CDC recommendations. PMID:25180514

  12. Drug formulations intended for the global market should be tested for stability under tropical climatic conditions.

    PubMed

    Risha, P G; Vervaet, C; Vergote, G; Bortel, L Van; Remon, J P

    2003-06-01

    The quality of drugs imported into developing countries having a tropical climate may be adversely affected if their formulations have not been optimized for stability under these conditions. The present study investigated the influence of tropical climate conditions (class IV: 40 degrees C, 75% relative humidity) on the drug content, in vitro dissolution and oral bioavailability of different formulations of two essential drugs marketed in Tanzania: diclofenac sodium and ciprofloxacin tablets. Before and after 3 and 6 months storage under class IV conditions the drug content and in vitro dissolution were evaluated using United States Pharmacopoeia (USP) 24 methods. Following a randomized four-period cross-over study, the pharmacokinetic parameters of drug formulations stored for 3 months under class IV conditions were compared with those stored at ambient conditions. Drug content and drug release from all tested ciprofloxacin formulations were within USP-24 requirements and remained stable during storage at simulated tropical conditions. Oral bioavailability was also not influenced by tropical conditions. The dissolution rate of two diclofenac formulations (Diclo 50 manufactured by Camden and Dicloflame 50 manufactured by Intas) reduced significantly during storage under class IV conditions. After oral administration Camden tablets stored for 3 months under class IV conditions showed a reduction in C(max) (90% CI of C(max) ratio: 0.59 - 0.76). This reduction was smaller than expected based on the in vitro tests. Some drug formulations imported into Tanzania are not optimized for stability in a tropical climate. Manufacturers and regulatory authorities should pay more attention to the WHO recommendations for testing the stability of drugs under tropical climate conditions. Efforts should be made to improve the in vitro tests to better predict the bioavailability.

  13. Evaluation of PCR testing of ethanol-fixed nasal swab specimens as an augmented surveillance strategy for influenza virus and adenovirus identification.

    PubMed

    Krafft, A E; Russell, K L; Hawksworth, A W; McCall, S; Irvine, M; Daum, L T; Connoly, J L; Reid, A H; Gaydos, J C; Taubenberger, J K

    2005-04-01

    Viral culture isolation has been widely accepted as the "gold standard" for laboratory confirmation of viral infection; however, it requires ultralow temperature specimen storage. Storage of specimens in ethanol at room temperature could expand our ability to conduct active surveillance and retrospective screenings of viruses with rapid and inexpensive real-time PCR tests, including isolates from remote regions where freezing specimens for culture is not feasible. Molecular methods allow for rapid identification of viral pathogens without the need to maintain viability. We hypothesized that ethanol, while inactivating viruses, can preserve DNA and RNA for PCR-based methods. To evaluate the use of ethanol-stored specimens for augmenting surveillance for detection of influenza viruses A and B and adenoviruses (AdV), paired nasal swab specimens were collected from 384 recruits with febrile respiratory illness at Fort Jackson, S.C., in a 2-year study. One swab was stored at ambient temperature in 100% ethanol for up to 6 months, and the other swab was stored at -70 degrees C in viral medium. For viral detection, frozen specimens were cultured for a variety of respiratory viruses, and ethanol-fixed specimens were tested with TaqMan (TM) probe and LightCycler SYBR green (SG) melting curve assays with at least two different PCR targets for each virus. The sensitivities of the TM and SG assays on specimens stored in ethanol for 1 month were 75% and 58% for influenza A, 89% and 67% for influenza B, and 93 to 98% and 57% for AdV, respectively. Lower specificities of the real-time assays corresponded to the increased detection of PCR-positive but culture-negative specimens. Influenza virus RNA was detected as well or better after 6 months of storage in ethanol.

  14. Using spatio-temporal surveillance data to test the infectious environment of children before type 1 diabetes diagnosis

    PubMed Central

    Le Fur, Sophie; Valtat, Sophie; Kamatani, Yoichiro; Lathrop, Mark; Valleron, Alain-Jacques

    2017-01-01

    The “hygiene hypothesis” postulates that reduced exposure to infections favours the development of autoimmunity and childhood type 1 diabetes (T1D). But on the other side, viruses, notably enteroviruses, are suspected to trigger T1D. The assessment of the possible relationships between infections and T1D still defies the classical tools of epidemiology. We report the methods and results of a geographical approach that maps the addresses of patients to a communicable diseases surveillance database. We mapped the addresses of patients at birth, infancy and T1D diagnosis to the weekly estimates of the regional incidences of 5 frequent communicable diseases routinely collected since 1984 by the French Sentinel network. The pre-diagnostic infectious environment of 3548 patients with T1D diagnosed between 0.5 and 15 years was compared to those of 100 series of age-matched “virtual controls” drawn randomly on the map. Associations were classified as “suggestive” (summer diarrhea, SD, and varicella, V) when p< 0.05, or “significant” (influenza-like infections, ILI) when they passed the Bonferroni correction for FDR. Exposure to ILI and SD were associated with T1D risk, while V seemed protective. In the subset of 2521 patients for which we had genome wide data, we used a case-only approach to search for interactions between SNPs and the infectious environment as defined by the Sentinel database. Two SNPs, rs116624278 and rs77232854, showed significant interaction with exposure to V between 1 and 3 years of life. The infectious associations found should be taken as possible markers of patients’ environment, not as direct causative factors of T1D. They require replication in other populations. The increasing public availability of geographical environmental databases will expand the present approach to map thousands of environmental factors to the lifeline of patients affected by various diseases. PMID:28152013

  15. Using spatio-temporal surveillance data to test the infectious environment of children before type 1 diabetes diagnosis.

    PubMed

    Bougnères, Pierre; Le Fur, Sophie; Valtat, Sophie; Kamatani, Yoichiro; Lathrop, Mark; Valleron, Alain-Jacques

    2017-01-01

    The "hygiene hypothesis" postulates that reduced exposure to infections favours the development of autoimmunity and childhood type 1 diabetes (T1D). But on the other side, viruses, notably enteroviruses, are suspected to trigger T1D. The assessment of the possible relationships between infections and T1D still defies the classical tools of epidemiology. We report the methods and results of a geographical approach that maps the addresses of patients to a communicable diseases surveillance database. We mapped the addresses of patients at birth, infancy and T1D diagnosis to the weekly estimates of the regional incidences of 5 frequent communicable diseases routinely collected since 1984 by the French Sentinel network. The pre-diagnostic infectious environment of 3548 patients with T1D diagnosed between 0.5 and 15 years was compared to those of 100 series of age-matched "virtual controls" drawn randomly on the map. Associations were classified as "suggestive" (summer diarrhea, SD, and varicella, V) when p< 0.05, or "significant" (influenza-like infections, ILI) when they passed the Bonferroni correction for FDR. Exposure to ILI and SD were associated with T1D risk, while V seemed protective. In the subset of 2521 patients for which we had genome wide data, we used a case-only approach to search for interactions between SNPs and the infectious environment as defined by the Sentinel database. Two SNPs, rs116624278 and rs77232854, showed significant interaction with exposure to V between 1 and 3 years of life. The infectious associations found should be taken as possible markers of patients' environment, not as direct causative factors of T1D. They require replication in other populations. The increasing public availability of geographical environmental databases will expand the present approach to map thousands of environmental factors to the lifeline of patients affected by various diseases.

  16. Tests of nonuniversality of the stock return distributions in an emerging market

    NASA Astrophysics Data System (ADS)

    Mu, Guo-Hua; Zhou, Wei-Xing

    2010-12-01

    There is convincing evidence showing that the probability distributions of stock returns in mature markets exhibit power-law tails and both the positive and negative tails conform to the inverse cubic law. It supports the possibility that the tail exponents are universal at least for mature markets in the sense that they do not depend on stock market, industry sector, and market capitalization. We investigate the distributions of intraday returns at different time scales ( Δt=1 , 5, 15, and 30 min) of all the A-share stocks traded in the Chinese stock market, which is the largest emerging market in the world. We find that the returns can be well fitted by the q -Gaussian distribution and the tails have power-law relaxations with the exponents increasing with Δt and being well outside the Lévy stable regime for individual stocks. We provide statistically significant evidence showing that, at small time scales Δt<15min , the exponents logarithmically decrease with the turnover rate and increase with the market capitalization. When Δt>15min , no conclusive evidence is found for a possible dependence of the tail exponent on the turnover rate or the market capitalization. Our findings indicate that the intraday return distributions at small time scales are not universal in emerging stock markets but might be universal at large time scales.

  17. Tests of nonuniversality of the stock return distributions in an emerging market.

    PubMed

    Mu, Guo-Hua; Zhou, Wei-Xing

    2010-12-01

    There is convincing evidence showing that the probability distributions of stock returns in mature markets exhibit power-law tails and both the positive and negative tails conform to the inverse cubic law. It supports the possibility that the tail exponents are universal at least for mature markets in the sense that they do not depend on stock market, industry sector, and market capitalization. We investigate the distributions of intraday returns at different time scales ( Δt=1, 5, 15, and 30 min) of all the A-share stocks traded in the Chinese stock market, which is the largest emerging market in the world. We find that the returns can be well fitted by the q-Gaussian distribution and the tails have power-law relaxations with the exponents increasing with Δt and being well outside the Lévy stable regime for individual stocks. We provide statistically significant evidence showing that, at small time scales Δt<15 min, the exponents logarithmically decrease with the turnover rate and increase with the market capitalization. When Δt>15 min, no conclusive evidence is found for a possible dependence of the tail exponent on the turnover rate or the market capitalization. Our findings indicate that the intraday return distributions at small time scales are not universal in emerging stock markets but might be universal at large time scales.

  18. Methicillin-resistant Staphylococcus aureus in nasal surveillance swabs at an intensive care unit: an evaluation of the LightCycler MRSA advanced test.

    PubMed

    Huh, Hee Jin; Kim, Eu Suk; Chae, Seok Lae

    2012-11-01

    We compared the LightCycler MRSA advanced test (Roche Diagnostics, Germany) with enrichment culture methods to evaluate the relative diagnostic performance of the LightCycler MRSA advanced test for active surveillance in a high-prevalence setting. A total of 342 nasal swab specimens were obtained from patients in the intensive care unit at admission and on the seventh day for follow-up. The results of LightCycler MRSA advanced test were compared to those of the enrichment culture. For discrepant results, mecA gene PCR was performed. For the detection of methicillin-resistant Staphylococcus aureus (MRSA), the LightCycler MRSA advanced test showed 98.5% sensitivity and 78.6% specificity and had positive and negative predictive values of 75.0% and 98.8%, respectively. A total of 46 samples had discrepant results between the LightCycler MRSA advanced test and enrichment culture. Of the 44 specimens that were positive in the LightCycler MRSA advanced test but negative by enrichment culture, mecA genes were detected in 37 specimens. In addition, of the original 44 cases, 21 patients had a history of MRSA colonization or infection within the last month; of those 21 specimens, 20 were positive for mecA gene as shown by PCR. Seven mecA-negative discrepant specimens comprised 3 methicillin-sensitive S. aureus-culture positive and only 2 patients had MRSA infections. Despite its low specificity and positive predictive value, the LightCycler MRSA advanced test could serve as a rapid test for patients colonized with MRSA.

  19. Correlates of HIV Testing among Female Sex Workers in Iran: Findings of a National Bio-Behavioural Surveillance Survey.

    PubMed

    Shokoohi, Mostafa; Karamouzian, Mohammad; Khajekazemi, Razieh; Osooli, Mehdi; Sharifi, Hamid; Haghdoost, Ali Akbar; Kamali, Kianoush; Mirzazadeh, Ali

    2016-01-01

    Female sex workers (FSWs) are the second most affected population by HIV in Iran. However, their HIV testing practices are poorly understood. The aim of this study was to investigate testing and its associated factors among HIV negative FSWs. Using facility based sampling, 1005 FSWs were recruited in 14 cities of Iran in 2010. Biological and survey data were collected through dried blood spot testing and standardized risk assessment questionnaire, respectively. In this paper, the prevalence of HIV testing and its correlates were explored among 714 HIV-negative FSWs using descriptive statistics and logistic regression models. Overall 65.4% had not tested in the past year. Only 27.5% had tested in the past year and received their results. FSWs who perceived themselves at risk of HIV (Adjusted Odds Ratio (AOR) = 8.35, 95% CI: 1.46, 47.6), had received free condom during past year (AOR = 3.90, 95% CI: 1.67, 9.14), started sex work at an older age (AOR18-24 = 2.83, 95% CI: 1.14, 7.0; AOR >24 = 2.76, 95% CI: 1.11, 6.84), and knew an HIV testing site (AOR = 5.67, 95% CI: 2.60, 12.4) had a significantly higher chance of having a recent HIV test result. Less than one third of FSWs in Iran knew their recent HIV status. Interventions to help FSWs evaluate their potential risk for HIV and integrate HIV testing services in condom distribution programs, could be viable strategies in increasing HIV testing uptake among FSWs. Health policy makers should also try to de-stigmatize HIV testing, identify the barriers to HIV testing, and make HIV testing sites more visible to FSWs.

  20. 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.

  1. 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.

  2. Test of the Behavioral Perspective Model in the Context of an E-Mail Marketing Experiment

    ERIC Educational Resources Information Center

    Sigurdsson, Valdimar; Menon, R. G. Vishnu; Sigurdarson, Johannes Pall; Kristjansson, Jon Skafti; Foxall, Gordon R.

    2013-01-01

    An e-mail marketing experiment based on the behavioral perspective model was conducted to investigate consumer choice. Conversion e-mails were sent to two groups from the same marketing database of registered consumers interested in children's books. The experiment was based on A-B-A-C-A and A-C-A-B-A withdrawal designs and consisted of sending B…

  3. Test of the Behavioral Perspective Model in the Context of an E-Mail Marketing Experiment

    ERIC Educational Resources Information Center

    Sigurdsson, Valdimar; Menon, R. G. Vishnu; Sigurdarson, Johannes Pall; Kristjansson, Jon Skafti; Foxall, Gordon R.

    2013-01-01

    An e-mail marketing experiment based on the behavioral perspective model was conducted to investigate consumer choice. Conversion e-mails were sent to two groups from the same marketing database of registered consumers interested in children's books. The experiment was based on A-B-A-C-A and A-C-A-B-A withdrawal designs and consisted of sending B…

  4. 75 FR 71155 - Market Test of Experimental Product: “Alternative Postage Payment Method for Greeting Cards”

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-22

    ... From the Federal Register Online via the Government Publishing Office POSTAL SERVICE Market Test of Experimental Product: ``Alternative Postage Payment Method for Greeting Cards'' AGENCY: Postal... Postage Payment Method for Greeting Cards'' experimental product on January 2, 2011. The Postal Service...

  5. The hygiene and marketing of fresh cream as assessed by the methylene blue test

    PubMed Central

    Mogford, Hilary

    1971-01-01

    The hygiene and marketing of fresh cream in England and Wales was investigated by a working party of the Public Health Laboratory Service (PHLS) between 1 October 1968 and 31 July 1969. Thirty-one cream-producing dairies were visited and observations made in the light of the Code of Practice published by the Milk and Milk Products Technical Advisory Committee of the Ministry of Agriculture, Fisheries and Food, and the Scottish Home and Health Department. Suggestions are made in this report to strengthen the code. A total of 5184 samples of fresh cream comprising 4385 heat-treated, 282 clotted and 517 untreated were examined. Details of production, age of the cream, distance and mode of distribution along the retail chain were available for most samples, and this history was, as far as possible, related to the laboratory findings. In the laboratory the samples were examined by the methylene blue test, colony count, coliform and Escherichia coli I test and for pathogens. Staphylococcus aureus was grown from 59 out of 3417 samples of cream; 54 of these were from untreated cream. Phage typing indicated that a proportion of these strains were of animal, presumably bovine, origin. Other human pathogens isolated included one each of Salmonella typhimurium, Brucella abortus, E. coli type O126 and Clostridium welchii. It appeared that heat-treated cream was much better, bacteriologically, than untreated; and that large dairies, in general, had better premises, more hygienic methods of preparation and the advantages of mechanical filling and capping of cartons; thus they offered the consumer a better product, bacteriologically, than some of the smaller dairies. A statistical analysis of the results of the tests used showed the methylene blue test, in spite of some anomalies, to be of more use as a screening test than any of the others. As this test is cheap and easy to carry out, the working party thought that it should be the test of choice. In view of the known anomalies

  6. Extragenital Gonorrhea and Chlamydia Testing and Infection Among Men Who Have Sex With Men—STD Surveillance Network, United States, 2010–2012

    PubMed Central

    Patton, Monica E.; Kidd, Sarah; Llata, Eloisa; Stenger, Mark; Braxton, Jim; Asbel, Lenore; Bernstein, Kyle; Gratzer, Beau; Jespersen, Megan; Kerani, Roxanne; Mettenbrink, Christie; Mohamed, Mukhtar; Pathela, Preeti; Schumacher, Christina; Stirland, Ali; Stover, Jeff; Tabidze, Irina; Kirkcaldy, Robert D.; Weinstock, Hillard

    2015-01-01

    Background Gonorrhea (GC) and chlamydia (CT) are the most commonly reported notifiable diseases in the United States. The Centers for Disease Control and Prevention recommends that men who have sex with men (MSM) be screened for urogenital GC/CT, rectal GC/CT, and pharyngeal GC. We describe extragenital GC/CT testing and infections among MSM attending sexually transmitted disease (STD) clinics. Methods The STD Surveillance Network collects patient data from 42 STD clinics. We assessed the proportion of MSM attending these clinics during July 2011–June 2012 who were tested and positive for extragenital GC/CT at their most recent visit or in the preceding 12 months and the number of extragenital infections that would have remained undetected with urethral screening alone. Results Of 21 994 MSM, 83.9% were tested for urogenital GC, 65.9% for pharyngeal GC, 50.4% for rectal GC, 81.4% for urogenital CT, 31.7% for pharyngeal CT, and 45.9% for rectal CT. Of MSM tested, 11.1% tested positive for urogenital GC, 7.9% for pharyngeal GC, 10.2% for rectal GC, 8.4% for urogenital CT, 2.9% for pharyngeal CT, and 14.1% for rectal CT. More than 70% of extragenital GC infections and 85% of extragenital CT infections were associated with negative urethral tests at the same visit and would not have been detected with urethral screening alone. Conclusions Extragenital GC/CT was common among MSM attending STD clinics, but many MSM were not tested. Most extragenital infections would not have been identified, and likely would have remained untreated, with urethral screening alone. Efforts are needed to facilitate implementation of extragenital GC/CT screening recommendations for MSM. PMID:24647015

  7. Unexpectedly high leprosy seroprevalence detected using a random surveillance strategy in midwestern Brazil: A comparison of ELISA and a rapid diagnostic test.

    PubMed

    Frade, Marco Andrey C; de Paula, Natália A; Gomes, Ciro M; Vernal, Sebastian; Bernardes Filho, Fred; Lugão, Helena B; de Abreu, Marilda M M; Botini, Patrícia; Duthie, Malcolm S; Spencer, John S; Soares, Rosa Castália F R; Foss, Norma T

    2017-02-01

    Leprosy diagnosis is mainly based on clinical evaluation, although this approach is difficult, especially for untrained physicians. We conducted a temporary campaign to detect previously unknown leprosy cases in midwestern Brazil and to compare the performance of different serological tests. A mobile clinic was stationed at the main bus terminal in Brasília, Brazil. Volunteers were quizzed and given a clinical exam to allow categorization as either patients, known contacts of patients or non-contacts, and blood was collected to determine anti-PGL-I and anti-LID-1 antibody titers by ELISA and by the NDO-LID rapid test. New cases of leprosy and the impact of performing this broad random surveillance strategy were evaluated. Accuracy values and concordance between the test results were evaluated among all groups. Four hundred thirty-four individuals were evaluated, and 44 (10.1%) were diagnosed with leprosy. Borderline forms were the most frequent presentation. Both tests presented higher positivity in those individuals with multibacillary disease. Serological tests demonstrated specificities arround 70% for anti-PGL-1 and anti-LID ELISA; and arround 40% for NDO-LID. Sensitivities ranged from 48 to 62%. A substantial agreement between NDO-LID and ELISA with concomitant positive results was found within leprosy patients (Kappa index = 0.79 CI95% 0.36-1.22). The unexpectedly high leprosy prevalence in this population indicates ongoing community-based exposure to Mycobacterium leprae antigens and high rates of subclinical infection. All tests showed low specificity and sensitivity values and therefore cannot be considered for use as stand-alone diagnostics. Rather, considering their positivity among MB patients and non-patients, these tests can be considered effective tools for screening and identifying individuals at high risk who might benefit from regular monitoring.

  8. Unexpectedly high leprosy seroprevalence detected using a random surveillance strategy in midwestern Brazil: A comparison of ELISA and a rapid diagnostic test

    PubMed Central

    Bernardes Filho, Fred; de Abreu, Marilda M. M.; Botini, Patrícia; Duthie, Malcolm S.; Spencer, John S.; Soares, Rosa Castália F. R.

    2017-01-01

    Background Leprosy diagnosis is mainly based on clinical evaluation, although this approach is difficult, especially for untrained physicians. We conducted a temporary campaign to detect previously unknown leprosy cases in midwestern Brazil and to compare the performance of different serological tests. Methods A mobile clinic was stationed at the main bus terminal in Brasília, Brazil. Volunteers were quizzed and given a clinical exam to allow categorization as either patients, known contacts of patients or non-contacts, and blood was collected to determine anti-PGL-I and anti-LID-1 antibody titers by ELISA and by the NDO-LID rapid test. New cases of leprosy and the impact of performing this broad random surveillance strategy were evaluated. Accuracy values and concordance between the test results were evaluated among all groups. Results Four hundred thirty-four individuals were evaluated, and 44 (10.1%) were diagnosed with leprosy. Borderline forms were the most frequent presentation. Both tests presented higher positivity in those individuals with multibacillary disease. Serological tests demonstrated specificities arround 70% for anti-PGL-1 and anti-LID ELISA; and arround 40% for NDO-LID. Sensitivities ranged from 48 to 62%. A substantial agreement between NDO-LID and ELISA with concomitant positive results was found within leprosy patients (Kappa index = 0.79 CI95% 0.36–1.22). Conclusions The unexpectedly high leprosy prevalence in this population indicates ongoing community-based exposure to Mycobacterium leprae antigens and high rates of subclinical infection. All tests showed low specificity and sensitivity values and therefore cannot be considered for use as stand-alone diagnostics. Rather, considering their positivity among MB patients and non-patients, these tests can be considered effective tools for screening and identifying individuals at high risk who might benefit from regular monitoring. PMID:28231244

  9. Clinical Microbiology Laboratories' Adoption of Culture-Independent Diagnostic Tests Is a Threat to Foodborne-Disease Surveillance in the United States.

    PubMed

    Shea, Shari; Kubota, Kristy A; Maguire, Hugh; Gladbach, Stephen; Woron, Amy; Atkinson-Dunn, Robyn; Couturier, Marc Roger; Miller, Melissa B

    2017-01-01

    INTRODUCTIONIn November 2015, the Centers for Disease Control and Prevention (CDC) sent a letter to state and territorial epidemiologists, state and territorial public health laboratory directors, and state and territorial health officials. In this letter, culture-independent diagnostic tests (CIDTs) for detection of enteric pathogens were characterized as "a serious and current threat to public health surveillance, particularly for Shiga toxin-producing Escherichia coli (STEC) and Salmonella" The document says CDC and its public health partners are approaching this issue, in part, by "reviewing regulatory authority in public health agencies to require culture isolates or specimen submission if CIDTs are used." Large-scale foodborne outbreaks are a continuing threat to public health, and tracking these outbreaks is an important tool in shortening them and developing strategies to prevent them. It is clear that the use of CIDTs for enteric pathogen detection, including both antigen detection and multiplex nucleic acid amplification techniques, is becoming more widespread. Furthermore, some clinical microbiology laboratories will resist the mandate to require submission of culture isolates, since it will likely not improve patient outcomes but may add significant costs. Specimen submission would be less expensive and time-consuming for clinical laboratories; however, this approach would be burdensome for public health laboratories, since those laboratories would need to perform culture isolation prior to typing. Shari Shea and Kristy Kubota from the Association of Public Health Laboratories, along with state public health laboratory officials from Colorado, Missouri, Tennessee, and Utah, will explain the public health laboratories' perspective on why having access to isolates of enteric pathogens is essential for public health surveillance, detection, and tracking of outbreaks and offer potential workable solutions which will allow them to do this. Marc Couturier of

  10. Dried blood spots for HIV-1 drug resistance and viral load testing: A review of current knowledge and WHO efforts for global HIV drug resistance surveillance.

    PubMed

    Bertagnolio, Silvia; Parkin, Neil T; Jordan, Michael; Brooks, James; García-Lerma, J Gerardo

    2010-01-01

    HIV-1 drug resistance genotyping is an essential component of the World Health Organization global HIV Drug Resistance (HIVDR) prevention and assessment strategy. Plasma is considered to be the most appropriate specimen type for HIV-1 drug resistance genotyping. However, use of plasma may not be feasible in rural, remote areas in resource-limited settings since its preparation and storage requires personnel and laboratory infrastructure that is often lacking. An alternative specimen type for HIVDR genotyping is dried blood spots (DBS). DBS can be made from blood drawn for routine clinical or surveillance purposes without special laboratory processing. The filter paper used is relatively inexpensive, easily obtained and stored, and although procedures for making DBS must be followed precisely, the training required is less intensive than that required for plasma separation. HIV nucleic acids are generally stable over long periods of time and freezing is not required unless storage over two weeks is planned. In addition, DBS are more easily transported than plasma because they can be shipped as non-hazardous materials using regular mail or courier services. Many studies have reported the successful genotyping of HIV-1 from DBS and some have shown a high genotypic concordance with plasma genotypes despite potential DNA interferences. During the past few years DBS have started to be widely used for HIV-1 drug resistance testing, and an increased number of reports from resource-limited areas have indicated DBS as the preferred specimen type for transmitted HIV-1 drug resistance surveillance where plasma collection is not feasible. The World Health Organization has brought together a group of experts (WHO HIVResNet DBS working group) to review current data on DBS preparation, storage, and transport conditions, and provide a reference protocol, which is also summarized in this article.

  11. Surveillance of pesticide residues in fruits and vegetables from Accra Metropolis markets, Ghana, 2010-2012: a case study in Sub-Saharan Africa.

    PubMed

    Fosu, Paul Osei; Donkor, Augustine; Ziwu, Cephas; Dubey, Brajesh; Kingsford-Adaboh, Robert; Asante, Isaac; Nyarko, Stephen; Tawiah, Rose; Nazzah, Noble

    2017-07-01

    Monitoring of pesticide residues in food commodities of plant origin is part of the regular controls on food to safeguard consumer's health. This study reports for the first time in Ghana a 3-year (2010-2012) monitoring of pesticide contamination of fruits and vegetables and their health implications. A total of 3483 samples were purchased in notable markets within Accra Metropolis and analysed for pesticide residues, employing the modified quick, easy, cheap, effective, rugged and safe analytical procedure. The results indicated that almost all the fruits and vegetables studied had residues above maximum residue limits (MRLs). The commodities with the greatest concentrations exceeding the European Union (EU) MRLs were long green beans (60.6%) and lettuce (57.1%) with watermelon (10%) and green pepper (8.6%) having the least. The relative occurrence of the pesticides was fenvalerate 11.3%, fenitrothion 5.6%, lambda-cyhalothrin 3.6%, dimethoate 3.2%, permethrin 2.7% and deltamethrin 2.2%. These results will serve as a baseline on which annual or other long-term studies could be compared with, thus emphasizing the need for continuous monitoring programmes to regulate trends of pesticide residues in fruits and vegetables to safeguard the consumers' health.

  12. [Active surveillance of prostate cancer].

    PubMed

    Ploussard, G; Hennequin, C; Rozet, F

    2017-10-01

    Several prospective studies have demonstrated the safety of active surveillance as a first treatment of prostate cancer. It spares many patients of a useless treatment, with its potential sequelae. Patients with a low-risk cancer are all candidates for this approach, as recommended by the American Society of Clinical Oncology (ASCO). Some patients with an intermediate risk could be also concerned by active surveillance, but this is still being discussed. Currently, the presence of grade 4 lesions on biopsy is a contra-indication. Modalities included a repeated prostate specific antigen test and systematic rebiopsy during the first year after diagnosis. MRI is now proposed to better select patients at inclusion and also during surveillance. No life style changes or drugs are significantly associated with a longer duration of surveillance. Copyright © 2017. Published by Elsevier SAS.

  13. HIV testing behaviors and attitudes after adoption of name-to-code HIV case surveillance in Washington State.

    PubMed

    Hopkins, Sharon G; Gelfand, Sarah E; Buskin, Susan E; Kent, James B; Kahle, Erin M; Barkan, Susan E

    2005-01-01

    Controversy over HIV reporting in Washington State raised concerns that name-to-code reporting might reduce HIV testing. We assessed HIV testing and the influence of reporting among people at risk for HIV. An anonymous survey was conducted 9 months after HIV reporting began. Recruitment for men who have sex with men was at bars; high-risk heterosexuals at a sexually transmitted disease clinic; and injection drug users at needle exchange sites. Eighty-nine percent of 267 participants had been tested for HIV at least once but only half reported testing regularly. Injection drug users and men who have sex with men were more likely than HRH to report regular testing. Main reasons for delaying testing were thinking that HIV exposure was unlikely or not wanting to think about being HIV positive; concern about government reporting was cited by only 2%. Over half the respondents hadn't heard about the new name-to-code HIV reporting mechanism, although 69% thought there was some type of HIV reporting. Only 18% correctly identified the mechanism of HIV reporting. HIV prevention programs should focus on the most common reasons for delaying or avoiding HIV testing: believing that one has not been exposed to HIV, and the fear of learning that one is HIV positive.

  14. Analysis of laboratory testing results collected in an enhanced chlamydia surveillance system in Australia, 2008-2010.

    PubMed

    Dimech, Wayne; Lim, Megan S C; Van Gemert, Caroline; Guy, Rebecca; Boyle, Douglas; Donovan, Basil; Hellard, Margaret

    2014-06-12

    Chlamydial infection is the most common notifiable disease in Australia, Europe and the US. Australian notifications of chlamydia rose four-fold from 20,274 cases in 2002 to 80,846 cases in 2011; the majority of cases were among young people aged less than 29 years. Along with test positivity rates, an understanding of the number of tests performed and the demographics of individuals being tested are key epidemiological indicators. The ACCESS Laboratory Network was established in 2008 to address this issue. The ACCESS Laboratory Network collected chlamydia testing data from 15 laboratories around Australia over a three-year period using data extraction software. All chlamydia testing data from participating laboratories were extracted from the laboratory information system; patient identifiers converted to a unique, non-reversible code and de-identified data sent to a single database. Analysis of data by anatomical site included all specimens, but in age and sex specific analysis, only one testing episode was counted. From 2008 to 2010 a total of 628,295 chlamydia tests were referred to the 15 laboratories. Of the 592,626 individual episodes presenting for testing, 70% were from female and 30% from male patients. In female patients, chlamydia positivity rate was 6.4% overall; the highest rate in 14 year olds (14.3%). In male patients, the chlamydia positivity rate was 9.4% overall; the highest in 19 year olds (16.5%). The most common sample type was urine (57%). In 3.2% of testing episodes, multiple anatomical sites were sampled. Urethral swabs gave the highest positivity rate for all anatomical sites in both female (7.7%) and male patients (14%), followed by urine (7.6% and 9.4%, respectively) and eye (6.3% and 7.9%, respectively). The ACCESS Laboratory Network data are unique in both number and scope and are representative of chlamydia testing in both general practice and high-risk clinics. The findings from these data highlight much lower levels of testing in

  15. Analysis of laboratory testing results collected in an enhanced chlamydia surveillance system in Australia, 2008–2010

    PubMed Central

    2014-01-01

    Background Chlamydial infection is the most common notifiable disease in Australia, Europe and the US. Australian notifications of chlamydia rose four-fold from 20,274 cases in 2002 to 80,846 cases in 2011; the majority of cases were among young people aged less than 29 years. Along with test positivity rates, an understanding of the number of tests performed and the demographics of individuals being tested are key epidemiological indicators. The ACCESS Laboratory Network was established in 2008 to address this issue. Methods The ACCESS Laboratory Network collected chlamydia testing data from 15 laboratories around Australia over a three-year period using data extraction software. All chlamydia testing data from participating laboratories were extracted from the laboratory information system; patient identifiers converted to a unique, non-reversible code and de-identified data sent to a single database. Analysis of data by anatomical site included all specimens, but in age and sex specific analysis, only one testing episode was counted. Results From 2008 to 2010 a total of 628,295 chlamydia tests were referred to the 15 laboratories. Of the 592,626 individual episodes presenting for testing, 70% were from female and 30% from male patients. In female patients, chlamydia positivity rate was 6.4% overall; the highest rate in 14 year olds (14.3%). In male patients, the chlamydia positivity rate was 9.4% overall; the highest in 19 year olds (16.5%). The most common sample type was urine (57%). In 3.2% of testing episodes, multiple anatomical sites were sampled. Urethral swabs gave the highest positivity rate for all anatomical sites in both female (7.7%) and male patients (14%), followed by urine (7.6% and 9.4%, respectively) and eye (6.3% and 7.9%, respectively). Conclusions The ACCESS Laboratory Network data are unique in both number and scope and are representative of chlamydia testing in both general practice and high-risk clinics. The findings from these data

  16. Ethical and clinical practice considerations for genetic counselors related to direct-to-consumer marketing of genetic tests.

    PubMed

    Wade, Christopher H; Wilfond, Benjamin S

    2006-11-15

    Several companies utilize direct-to-consumer (DTC) advertising for genetic tests and some, but not all, bypass clinician involvement by offering DTC purchase of the tests. This article examines how DTC marketing strategies may affect genetic counselors, using available cardiovascular disease susceptibility tests as an illustration. The interpretation of these tests is complex and includes consideration of clinical validity and utility, and the further complications of gene-environment interactions and pleiotropy. Although it is unclear to what extent genetic counselors will encounter clients who have been exposed to DTC marketing strategies, these strategies may influence genetic counseling interactions if they produce directed interest in specific tests and unrealistic expectations for the tests' capacity to predict disease. Often, a client's concern about risk for cardiovascular diseases is best addressed by established clinical tests and a family history assessment. Ethical dilemmas may arise for genetic counselors who consider whether to accept clients who request test interpretation or to order DTC-advertised tests that require a clinician's authorization. Genetic counselors' obligations to care for clients extend to interpreting DTC tests, although this obligation may be fulfilled by referral or consultation with specialists. Genetic counselors do not have an obligation to order DTC-advertised tests that have minimal clinical validity and utility at a client's request. This can be a justified restriction on autonomy based on consideration of risks to the client, the costs, and the implications for society. Published 2006 Wiley-Liss, Inc.

  17. Dissolution testing of marketed rifampicin containing fixed dose combination formulations using a new discriminative media: a post marketing retrospective study.

    PubMed

    Panchagnula, R; Kumar Bajpai, A; Agrawal, S; Ashokraj, Y

    2006-10-01

    Currently recommended compendial dissolution methods for quality control of orally administered solid dosage forms of rifampicin containing formulations are not found to be able to forecast the in vivo performance. A recently proposed dissolution method of 0.01 N HCl at 50 rpm using paddle apparatus for screening was found to be more appropriate and able to predict the in vivo performance of those formulations. The objective of this investigation was to validate the new method of dissolution testing for solid dosage forms of rifampicin containing formulations using a basket apparatus and to compare it with the frequently recommended pharmacopeial method. In the present study the newly proposed dissolution condition (0.01 N HCl) was validated using six formulations of two, three and four drug combinations from two different manufacturers by basket method and compared with the widely recommended compendial medium. In this investigation, the appropriateness of the proposed methodology was confirmed by the dissolution results of the two FDC formulations (a two-drug and a four-drug combinations) that had previously passed the bioequivalence tests. It was found that the recommended dissolution medium of 0.01 N HCl can be used for screening of rifampicin containing formulations using both paddle and basket dissolution apparatus at 50 rpm and 100 rpm, respectively.

  18. Relationship between a Centers for Disease Control and Prevention expanded HIV testing initiative and past-year testing by race/ethnicity: a multilevel analysis of the Behavioral Risk Factor Surveillance System.

    PubMed

    Gaines, Tommi L; Caldwell, Julia T; Ford, Chandra L; Mulatu, Mesfin S; Godette, Dionne C

    2016-01-01

    The Centers for Disease Control and Prevention's (CDC) expanded testing initiative (ETI) aims to bolster HIV testing among populations disproportionately affected by the HIV epidemic by providing additional funding to health departments serving these communities. ETI prioritizes testing in clinical settings; therefore, we examined the relationship between state-level ETI participation and past-year HIV testing among a racially/ethnically diverse sample of adult respondents to the 2012 Behavioral Risk Factor Surveillance System who accessed health services within the 12 months prior to being interviewed. Controlling for individual- and state-level characteristics in a multilevel logistic regression model, ETI participation was independently and positively associated with past-year testing, but this association varied by race/ethnicity. Hispanics had higher odds (adjusted odds ratio [AOR]: 1.49; 95% CI: 1.11-2.02) and American Indian/Alaska Natives had lower odds (AOR: 0.66; 95% CI: 0.43-0.99) of testing if they resided in states with (vs. without) ETI participation. State-level ETI participation did not significantly alter past-year testing among other racial/ethnic groups. Prioritizing public health resources in states most affected by HIV can improve testing patterns, but other mechanisms likely influence which racial/ethnic groups undergo testing.

  19. HIV Incidence in Rural South Africa: Comparison of Estimates from Longitudinal Surveillance and Cross-Sectional cBED Assay Testing

    PubMed Central

    Bärnighausen, Till; Wallrauch, Claudia; Welte, Alex; McWalter, Thomas A.; Mbizana, Nhlanhla; Viljoen, Johannes; Graham, Natalie; Tanser, Frank; Puren, Adrian; Newell, Marie-Louise

    2008-01-01

    Background The BED IgG-Capture Enzyme Immunoassay (cBED assay), a test of recent HIV infection, has been used to estimate HIV incidence in cross-sectional HIV surveys. However, there has been concern that the assay overestimates HIV incidence to an unknown extent because it falsely classifies some individuals with non-recent HIV infections as recently infected. We used data from a longitudinal HIV surveillance in rural South Africa to measure the fraction of people with non-recent HIV infection who are falsely classified as recently HIV-infected by the cBED assay (the long-term false-positive ratio (FPR)) and compared cBED assay-based HIV incidence estimates to longitudinally measured HIV incidence. Methodology/Principal Findings We measured the long-term FPR in individuals with two positive HIV tests (in the HIV surveillance, 2003–2006) more than 306 days apart (sample size n = 1,065). We implemented four different formulae to calculate HIV incidence using cBED assay testing (n = 11,755) and obtained confidence intervals (CIs) by directly calculating the central 95th percentile of incidence values. We observed 4,869 individuals over 7,685 person-years for longitudinal HIV incidence estimation. The long-term FPR was 0.0169 (95% CI 0.0100–0.0266). Using this FPR, the cross-sectional cBED-based HIV incidence estimates (per 100 people per year) varied between 3.03 (95% CI 2.44–3.63) and 3.19 (95% CI 2.57–3.82), depending on the incidence formula. Using a long-term FPR of 0.0560 based on previous studies, HIV incidence estimates varied between 0.65 (95% CI 0.00–1.32) and 0.71 (95% CI 0.00–1.43). The longitudinally measured HIV incidence was 3.09 per 100 people per year (95% CI 2.69–3.52), after adjustment to the sex-age distribution of the sample used in cBED assay-based estimation. Conclusions/Significance In a rural community in South Africa with high HIV prevalence, the long-term FPR of the cBED assay is substantially lower than previous

  20. [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.

  1. [Measles surveillance in Germany. From sentinel to mandatory surveillance].

    PubMed

    Siedler, A; Grüber, A; Mankertz, A

    2013-09-01

    From September 1999 to March 2011, sentinel surveillance of measles was conducted by a self-selected sample of private physicians in Germany. From 2001, when mandatory surveillance for measles was established, two surveillance systems worked in parallel. The aim of this article is to summarize the strengths and limitations of sentinel versus mandatory surveillance. Active monthly reporting included case-based questionnaires on patients with (suspected) measles or zeroreporting. For confirmation of measles, the diagnostic patient specimens were sent to regional laboratories for serological tests or to the National Reference Laboratory (NRC). In the NRC in addition to serological tests measles-virus (MV) detection by PCR in urine, throat swabs, and oral fluid (since 2003) as well as MVgenotyping was offered. From January 2000 to December 2010, 934 out of 1,488 participating sentinel-practices did not see any measles case, while 554 reported 3,573 suspected cases. Measles was confirmed by laboratory testing in 801 cases, excluded in 473 cases, and the diagnosis remained uncertain in 215 cases. Of 3,100 analyzed cases, 2,712 (87 %) were unvaccinated, 217 (7 %) and 32 (1 %) were vaccinated with one or two doses, respectively, and for 139 (4 %) cases the vaccination status was unknown. The main reason for not being vaccinated against measles was refusal (n = 1,383). The confirmation rate was lower in the vaccinated than in the unvaccinated patients (19 % vs. 63 %). Since 2006, sentinel-cases have differed from notified cases by region and age. The proportion of sentinel cases from all NRC-investigated cases decreased from more than  50 % (2002) to less than  5 % (since 2007). Sentinel surveillance allowed for the detection of trends, delivered additional information for measles prevention, and played a major role in measles diagnostics. Since mandatory surveillance was established and sentinel surveillance no longer reflected the epidemiologic

  2. Imaging tests in staging and surveillance of non-metastatic breast cancer: changes in routine clinical practice and cost implications

    PubMed Central

    De Placido, S; De Angelis, C; Giuliano, M; Pizzi, C; Ruocco, R; Perrone, V; Bruzzese, D; Tommasielli, G; De Laurentiis, M; Cammarota, S; Arpino, G; Arpino, G

    2017-01-01

    Background: Although guidelines do not recommend computerised tomography (CT), positron emission tomography (PET) or magnetic resonance imaging (MRI) for the staging or follow-up of asymptomatic patients with non-metastatic breast cancer, they are often requested in routine clinical practice. The aim of this study was to determine the staging and follow-up patterns, and relative costs in a large population of breast cancer patients living and treated in a Southern Italian region. Methods: We analysed the clinical computerised information recorded by 567 primary-care physicians assisting about 650 000 inhabitants in the Campania region. Patients with non-metastatic breast cancer were identified and divided into calendar years from 2001 to 2010. The number of diagnostic tests prescribed per 100 patients (N/Pts) and the mean cost per patient was determined 3 months before diagnosis and up to 1 year after diagnosis. Costs are expressed in constant 2011 euros. Results: We identified 4680 newly diagnosed cases of asymptomatic non-metastatic breast cancer. N/Pts increased significantly (P<0.0001) from 2001 to 2010. The mean number of prescribed mammograms, bone scans, abdominal ultrasound and chest X-rays (‘routine tests'), and costs was unchanged. However, the number of CT, PET scans and MRI (‘new tests')prescriptions almost quadrupled and the mean cost per patient related to these procedures significantly increased from €357 in 2001 to €830 in 2010 (P<0.0001). Conclusions: New test prescriptions and relative costs significantly and steadily increased throughout the study period. At present there is no evidence that the delivery of new tests to asymptomatic patients improves breast cancer outcome. Well-designed clinical trials are urgently needed to shed light on the impact of these tests on clinical outcome and overall survival. PMID:28170371

  3. Choosing the correct empirical antibiotic for urinary tract infection in pediatric: Surveillance of antimicrobial susceptibility pattern of Escherichia coli by E-Test method.

    PubMed

    Sedighi, Iraj; Solgi, Abbas; Amanati, Ali; Alikhani, Mohammad Yousef

    2014-12-01

    Urinary Tract Infections (UTIs) are of the most common bacterial diseases worldwide. We investigate the antibiotic susceptibility patterns of Escherichia coli (E. coli) strains isolated from pediatric patients with community acquired urinary tract infection (UTI) to find a clinical guidance for choosing a right empirical antibiotic in these patients. In this cross sectional study, 100 urine specimens which were positive for E. coli had been investigated for antibiotics susceptibility pattern. The susceptibility to Co-trimoxazol (25μg), Amikacin (30μg), Ceftriaxone (30μg), Nalidixic Acid (30μg), Cefixime (5μg), and Nitrofurantoin (300μg) tested with Disk diffusion agar and MIC determined with the E-test. Mean age of patients was 38 Months. Girls had greater proportion than boys (74 versus 26%). In Disk diffusion method, 26% of the isolates were susceptible to cotrimoxazole. Susceptibility to amikacin, ceftriaxone, nitrofurantoin, nalidixic acid and cefixime was 94%, 66%, 97%, 62% and 52%, respectively. By E-Test method and according to CLSI criteria susceptibility for co-trimoxazol, amikacin, ceftriaxone and nalidixic acid was 37%, 97%, 67% and 50%, respectively. The highest percentage of agreement between Disk diffusion and E-Test method was found for amikacin (96%) and the lowest percentage for co-trimoxazole (89%). Treatment failure, prolonged or repeated hospitalization, increased costs of care, and increased mortality are some consequence of bacterial resistance in UTIs. Misuse of antibiotics in each geographic location directly affects antibiotic resistance pattern. In the treatment of UTI, proper selection of antimicrobial agents should be relevant to the bacterial susceptibility testing surveillance. According to our results, amikacin as an injectable drug and nitrofurantoin as an oral agent could be used as a drug of choice in our region for children with UTIs.

  4. The modification and evaluation of an ELISA test for the surveillance of Mycobacterium avium subsp. paratuberculosis infection in wild ruminants

    PubMed Central

    2013-01-01

    Background Enzyme-linked immunosorbent assay (ELISA) is often used to test wildlife samples for Mycobacterium avium subsp. paratuberculosis (MAP) infection. However, commercially available kits are only validated for use with domestic ruminant species. A literature review was performed to document the current use of MAP serum ELISA in wild and semi-domestic ruminants. We then modified and evaluated a commercial ELISA kit (IDEXX Mycobacterium paratuberculosis Antibody Test Kit) for use with species for which it was not originally developed: elk (Cervus elaphus), bison (Bison bison) and caribou (Rangifer tarandus). We tested the affinity of different conjugates for immunoglobulin G (IgG) isolated from these species, performed checkerboard tests to determine the optimal dilutions of samples and conjugates, and established cut-off values using two different methods: a Receiver Operational Curve on a panel of known samples for elk, and an alternate method involving a panel of unknown serum samples for the three species. Results We found that the anti-bovine conjugate included in the IDEXX ELISA kit has limited affinity for elk, bison, and caribou IgG. Protein G showed good affinity for IgG of all three species, while anti-deer conjugate also bound elk and caribou IgG. Using Protein G with elk serum, a cut-off sample-to-positive (S/P) value of 0.22 was selected, resulting in a sensitivity and specificity of 73% and 90%, respectively, whereas, using an anti-deer conjugate with elk serum, an S/P cut-off value of 0.29 gave a sensitivity of 68%, with 100% specificity. Cut-off values for bison and caribou using the Protein G conjugate were 0.17 and 0.25 respectively. Conclusions Due to incomplete reporting and a lack of test validation, it is difficult to critically appraise results of many sero-surveys that have previously been done for MAP in wildlife. Commercial ELISA kits may have limited or no capacity to detect antibodies from species other than for which they were

  5. Influenza surveillance

    PubMed Central

    Pereira, M.; Assaad, F. A.; Delon, P. J.

    1978-01-01

    The main objectives of influenza surveillance are: to measure the impact of the disease by collection and analysis of epidemiological information on morbidity and mortality, and to anticipate future epidemics and pandemics by the collection and analysis of influenza viruses. The World Health Organization's influenza programme is based on the collaboration of 98 national influenza centres in 70 countries and the 2 WHO Collaborating Centres in Atlanta and London. Epidemiological information may be based on morbidity figures derived from a variety of sources such as returns from physicians or hospitals; mortality statistics or new claims for sickness benefit; school or industrial absenteeism, etc. The laboratory aspects of influenza epidemiology are certainly more uniformly covered than the statistical aspects. Since the advent of the A/Hong Kong/1/68 (H3N2) influenza virus A subtype there have been a number of variants with antigenic ”drift” but only three succeeded in causing widespread epidemics: A/England/42/72, A/Port Chalmers/1/73, and A/Victoria/3/75. In 1972, the influenza B virus also showed some antigenic ”drift”, the new variants being characterized by B/Hong Kong/5/72. Whenever a new variant appears, the degree of protection afforded to the population by the available vaccine is assessed. In the light of these data, WHO publishes annually in the Weekly epidemiological record recommendations formulated by the WHO Collaborating Centres on vaccine composition. PMID:78771

  6. Antimicrobial activity against a global collection of skin and skin structure pathogens: results from the Tigecycline Evaluation and Surveillance Trial (T.E.S.T.), 2010-2014.

    PubMed

    Tärnberg, Maria; Nilsson, Lennart E; Dowzicky, Michael J

    2016-08-01

    As part of the Tigecycline Evaluation and Surveillance Trial (T.E.S.T.) we report antimicrobial resistance among Gram-positive and Gram-negative isolates collected globally from integumentary sources between 2010 and 2014. Minimum inhibitory concentrations and antimicrobial resistance were determined according to Clinical and Laboratory Standards Institute guidelines (US Food and Drug Administration breakpoints against tigecycline). The Cochran-Armitage trend test was used to identify statistically significant changes in resistance. Global rates of methicillin-resistant Staphylococcus aureus (MRSA) and multidrug-resistant Acinetobacter baumannii were 38% and 43%, respectively. No S. aureus isolates were resistant to linezolid or vancomycin; all isolates were susceptible to tigecycline. Two percent of Enterococcus faecalis and 28% of Enterococcus faecium were vancomycin-resistant. Extended-spectrum β-lactamase (ESBL) producers accounted for 22% of Klebsiella pneumoniae and 16% of Escherichia coli. Resistance to minocycline among E. faecalis, E. faecium, K. pneumoniae, and E. coli decreased significantly (p<0.0001). There were significant increases (p<0.0001) in A. baumannii resistance to cefepime, ceftazidime, ceftriaxone, levofloxacin, meropenem, and piperacillin-tazobactam. Among isolates from integumentary sources, rates of MRSA and ESBL-producing Enterobacteriaceae are stabilizing. Carbapenems and tigecycline have retained their in vitro activity against Gram-positive and Gram-negative organisms. Few agents were active against A. baumannii; its increasing resistance is cause for concern. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

  7. The surveillant assemblage.

    PubMed

    Haggerty, K D; Ericson, R V

    2000-12-01

    George Orwell's 'Big Brother' and Michel Foucault's 'panopticon' have dominated discussion of contemporary developments in surveillance. While such metaphors draw our attention to important attributes of surveillance, they also miss some recent dynamics in its operation. The work of Gilles Deleuze and Felix Guattari is used to analyse the convergence of once discrete surveillance systems. The resultant 'surveillant assemblage' operates by abstracting human bodies from their territorial settings, and separating them into a series of discrete flows. These flows are then reassembled in different locations as discrete and virtual 'data doubles'. The surveillant assemblage transforms the purposes of surveillance and the hierarchies of surveillance, as well as the institution of privacy.

  8. Promoting HIV risk awareness and testing in Latinos living on the U.S.-Mexico border: the Tú No Me Conoces social marketing campaign.

    PubMed

    Olshefsky, Alisa M; Zive, Michelle M; Scolari, Rosana; Zuñiga, María

    2007-10-01

    Increased incidence of HIV/AIDS in Latinos warrants effective social marketing messages to promote testing. The Tú No Me Conoces (You Don't Know Me) social marketing campaign promoted awareness of HIV risk and testing in Latinos living on the California-Mexico border. The 8-week campaign included Spanish-language radio, print media, a Web site, and a toll-free HIV-testing referral hotline. We documented an increase in HIV testing at partner clinics; 28% of testers who heard or saw an HIV advertisement specifically identified our campaign. Improved understanding of effective social marketing messages for HIV testing in the growing Latino border population is warranted.

  9. Date of first positive HIV test: reliability of information collected for HIV/AIDS surveillance in the United States.

    PubMed Central

    Hall, H. Irene; Li, Jianmin; Campsmith, Michael; Sweeny, Patricia; Lee, Lisa M.

    2005-01-01

    OBJECTIVES: This study examined the reliability of the first positive HIV test date reported in the U.S. HIV/AIDS Reporting System (HARS). This date is essential to determine case counts for resource allocation for HIV treatment and prevention efforts. METHODS: The dates of first positive HIV tests reported by individuals with HIV in an interview survey conducted in 16 states (n=16,394, interviewed 1995-2002) were compared with the dates of HIV diagnosis reported to HARS. The percentage of agreement for the year of diagnosis and the weighed kappa (k) with 95% confidence intervals (CIs) was calculated. RESULTS: Self-reported year of diagnosis agreed with the year of diagnosis in HARS for 56% of date pairs (k=0.69; 95% CI 0.68, 0.70); 30% reported an earlier diagnosis year. Agreement differed by sex, age, race, exposure, and reason or place of testing (p<.01). Lower agreement was found when the self-reported diagnostic test was anonymous (k=0.57; 95% CI 0.52, 0.62) compared with confidential tests (k=0.66; 95% CI 0.64, 0.68). Lower agreement was also found for cases first reported with AIDS (k=0.58; 95% CI 0.55, 0.62) compared with cases first reported with HIV not AIDS (k=0.71; 95% CI 0.70, 0.73) as well as for participants interviewed three years or more after their HARS diagnosis date (k=0.55; 95% CI 0.52, 0.57) compared with those interviewed within one year (k=0.62; 95% CI 0.61, 0.63). More than 20% of participants in almost all groups, however, reported earlier diagnosis years than those recorded in HARS. CONCLUSION: As many as 30% of HIV diagnoses may have occurred earlier than recorded in HARS. Additional studies need to determine mechanisms to adequately capture diagnosis dates in HARS. PMID:15736337

  10. Imaging Surveillance After Primary Breast Cancer Treatment

    PubMed Central

    Lam, Diana L.; Houssami, Nehmat; Lee, Janie M.

    2017-01-01

    OBJECTIVE Current clinical guidelines are consistent in supporting annual mammography for women after treatment of primary breast cancer. Surveillance imaging beyond standard digital mammography, including digital breast tomosynthesis (DBT), breast ultrasound, and MRI, may improve outcomes. This article reviews the evidence on the performance and effectiveness of breast imaging modalities available for surveillance after treatment of sporadic unilateral primary breast cancer and identifies additional factors to be considered when selecting an imaging surveillance regimen. CONCLUSION Evidence review supports the use of mammography for surveillance after primary breast cancer treatment. Variability exists in guideline recommendations for surveillance initiation, interval, and cessation. DBT offers the most promise as a potential modality to replace standard digital mammography as a front-line surveillance test; a single published study to date has shown a significant decrease in recall rates compared with standard digital mammography alone. Most guidelines do not support the use of whole-breast ultrasound in breast cancer surveillance, and further studies are needed to define the characteristics of women who may benefit from MRI surveillance. The emerging evidence about surveillance imaging outcomes suggests that additional factors, including patient and imaging characteristics, tumor biology and gene expression profile, and choice of treatment, warrant consideration in selecting personalized posttreatment imaging surveillance regimens. PMID:28075622

  11. Reuse fo a Cold War Surveillance Drone to Flight Test a NASA Rocket Based Combined Cycle Engine

    NASA Technical Reports Server (NTRS)

    Brown, T. M.; Smith, Norm

    1999-01-01

    Plans for and early feasibility investigations into the modification of a Lockheed D21B drone to flight test the DRACO Rocket Based Combined Cycle (RBCC) engine are discussed. Modifications include the addition of oxidizer tanks, modern avionics systems, actuators, and a vehicle recovery system. Current study results indicate that the D21B is a suitable candidate for this application and will allow demonstrations of all DRACO engine operating modes at Mach numbers between 0.8 and 4.0. Higher Mach numbers may be achieved with more extensive modification. Possible project risks include low speed stability and control, and recovery techniques.

  12. Testing the feasibility of a hypothetical whaling-conservation permit market in Norway.

    PubMed

    Huang, Biao; Abbott, Joshua K; Fenichel, Eli P; Muneepeerakul, Rachata; Perrings, Charles; Gerber, Leah

    2017-02-24

    A "cap and trade" style system for managing whale harvests represents a potentially useful approach to resolve the current gridlock in international whale management. The establishment of whale permit markets, open to both whalers and conservationists, could reveal the strength of conservation demand. However, while much is known about demand for whale-based products there is uncertainty about demand for conservation and the willingness of conservation interests to engage in the market. This makes it difficult to predict the outcome of a hypothetical whale permit market. As a thought experiment, we develop a bioeconomic model to evaluate the influence of economic uncertainty about demand for whale conservation or harvest. We use simulations over a wide range of parameterizations of whaling and conservation demands to examine the potential ecological consequences of the establishment of a whale permit market in Norwegian waters under bounded (but substantial) economic uncertainty. We find that while a whale conservation market has the potential to yield a wide range of conservation and harvest outcomes, the most likely outcomes are those in which conservationists buy all whale permits. This article is protected by copyright. All rights reserved.

  13. Space Debris Symposium (A6.) Measurements and Space Surveillance (1.): Measurements of the Small Particle Debris Cloud from the 11 January, 2007 Chinese Anti-satellite Test

    NASA Technical Reports Server (NTRS)

    Matney, Mark J.; Stansbery, Eugene; J.-C Liou; Stokely, Christopher; Horstman, Matthew; Whitlock, David

    2008-01-01

    On January 11, 2007, the Chinese military conducted a test of an anti-satellite (ASAT) system, destroying their own Fengyun-1C spacecraft with an interceptor missile. The resulting hypervelocity collision created an unprecedented number of tracked debris - more than 2500 objects. These objects represent only those large enough for the US Space Surveillance Network (SSN) to track - typically objects larger than about 5-10 cm in diameter. There are expected to be even more debris objects at sizes too small to be seen and tracked by the SSN. Because of the altitude of the target satellite (865 x 845 km orbit), many of the debris are expected to have long orbital lifetimes and contribute to the orbital debris environment for decades to come. In the days and weeks following the ASAT test, NASA was able to use Lincoln Laboratory s Haystack radar on several occasions to observe portions of the ASAT debris cloud. Haystack has the capability of detecting objects down to less than one centimeter in diameter, and a large number of centimeter-sized particles corresponding to the ASAT cloud were clearly seen in the data. While Haystack cannot track these objects, the statistical sampling procedures NASA uses can give an accurate statistical picture of the characteristics of the debris from a breakup event. For years computer models based on data from ground hypervelocity collision tests (e.g., the SOCIT test) and orbital collision experiments (e.g., the P-78 and Delta-180 on-orbit collisions) have been used to predict the extent and characteristics of such hypervelocity collision debris clouds, but until now there have not been good ways to verify these models in the centimeter size regime. It is believed that unplanned collisions of objects in space similar to ASAT tests will drive the long-term future evolution of the debris environment in near-Earth space. Therefore, the Chinese ASAT test provides an excellent opportunity to test the models used to predict the future debris

  14. Space Debris Symposium (A6.) Measurements and Space Surveillance (1.): Measurements of the Small Particle Debris Cloud from the 11 January, 2007 Chinese Anti-satellite Test

    NASA Technical Reports Server (NTRS)

    Matney, Mark J.; Stansbery, Eugene; J.-C Liou; Stokely, Christopher; Horstman, Matthew; Whitlock, David

    2008-01-01

    On January 11, 2007, the Chinese military conducted a test of an anti-satellite (ASAT) system, destroying their own Fengyun-1C spacecraft with an interceptor missile. The resulting hypervelocity collision created an unprecedented number of tracked debris - more than 2500 objects. These objects represent only those large enough for the US Space Surveillance Network (SSN) to track - typically objects larger than about 5-10 cm in diameter. There are expected to be even more debris objects at sizes too small to be seen and tracked by the SSN. Because of the altitude of the target satellite (865 x 845 km orbit), many of the debris are expected to have long orbital lifetimes and contribute to the orbital debris environment for decades to come. In the days and weeks following the ASAT test, NASA was able to use Lincoln Laboratory s Haystack radar on several occasions to observe portions of the ASAT debris cloud. Haystack has the capability of detecting objects down to less than one centimeter in diameter, and a large number of centimeter-sized particles corresponding to the ASAT cloud were clearly seen in the data. While Haystack cannot track these objects, the statistical sampling procedures NASA uses can give an accurate statistical picture of the characteristics of the debris from a breakup event. For years computer models based on data from ground hypervelocity collision tests (e.g., the SOCIT test) and orbital collision experiments (e.g., the P-78 and Delta-180 on-orbit collisions) have been used to predict the extent and characteristics of such hypervelocity collision debris clouds, but until now there have not been good ways to verify these models in the centimeter size regime. It is believed that unplanned collisions of objects in space similar to ASAT tests will drive the long-term future evolution of the debris environment in near-Earth space. Therefore, the Chinese ASAT test provides an excellent opportunity to test the models used to predict the future debris

  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 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

  16. 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.

  17. 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.

  18. 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.

  19. Surveillance of Populations at Risk of Cholangiocarcinoma Development in Rural Communities of Thailand Using the Korat-CCA Verbal Screening Test.

    PubMed

    Kaewpitoon, Soraya J; Rujirakul, Ratana; Loyd, Ryan A; Panpimanmas, Sukij; Matrakool, Likit; Tongtawee, Taweesak; Kompor, Porntip; Norkaew, Jun; Chavengkun, Wasugree; Wakkhuwattapong, Parichart; Kujapun, Jirawoot; Ponphimai, Sukanya; Phatisena, Tanida; Eaksunti, Thawatchai; Polsripradist, Poowadol; Joosiri, Apinya; Sukkasam, Inchat; Padchasuwan, Natnapa; Kaewpitoon, Natthawut

    2016-01-01

    Cholangiocarcinoma (CCA) is a serious problem in Thailand, particularly in the northeastern region. Active surveillance in rural communities with an appropriat low-cost screening tool is required to facilitate early detection. Therefore, this study aimed to investigate the population at risk of CCA in Bua Yai district, Nakhon Ratchasima province, Northeastern Thailand using the Korat-CCA verbal screening test (KCVST) during June to October 2015. Reliability of KCVST demonstrated a Cronbach alpha coefficient=0.75 Stepwise-multiple regression showed that alcohol consumption was important for CCA screened, followed by agriculture and pesticide use, under-cooked cyprinoid fish consumption, praziquantel use, naïve northeastern people, opisthorchiasis, family relatives with CCA, and cholangitis or cholecystitis or gallstones, respectively. Population at risk for CCA was classified to low risk (63.4%), moderate risk (33.7%), and high risk (1.32%) for CCA. When CCA was screened using ultrasonography, 4 of 32 high risk participants had an abnormal biliary tract with dilated bile ducts. This study indicates that KCVST is a potential useful too which decrease the cost of large scale CCA screening.

  20. Location-based HIV behavioural surveillance among MSM in Auckland, New Zealand 2002-2011: condom use stable and more HIV testing.

    PubMed

    Saxton, Peter J W; Dickson, Nigel P; Hughes, Anthony J

    2014-03-01

    Over the last decade, annual HIV diagnoses among men who have sex with men (MSM) in New Zealand increased, then stabilised in 2006 and have not increased further. The aim was to examine trends in behaviours in order to better understand this pattern and inform community-based prevention. From 2002 to 2011, we conducted five repeat cross-sectional behavioural surveillance surveys among MSM at community locations in Auckland (fair day, gay bars, sex-on-site venues; n=6091). Participation was anonymous and self-completed. Recruitment methods were consistent at each round. Overall, the samples became more ethnically diverse and less gay community attached over time. Condom use during anal intercourse was stable across three partnering contexts (casual, current regular fuckbuddy, current regular boyfriend), with a drop among casual contacts in 2011 only. In the 6 months prior to surveys, there was a gradual decline over time in the proportion reporting >20 male partners, an increase in acquiring partners from the internet and increases in engagement in anal intercourse in some partnering contexts. HIV testing in the 12 months prior to surveys rose from 35.1% in 2002 to 50.4% in 2011, mostly from 2008. This first indepth examination of trends in HIV-related behaviours among five consecutive large and diverse samples of MSM in New Zealand does not suggest condom use is declining. However, subtle changes in sexual networks and partnering may be altering the epidemic determinants in this population and increasing exposure.

  1. Identifying an outbreak of a novel swine disease using test requests for porcine reproductive and respiratory syndrome as a syndromic surveillance tool

    PubMed Central

    2012-01-01

    Background Animal disease monitoring and surveillance are crucial for ensuring the health of animals, humans and the environment. Many studies have investigated the utility of monitoring syndromes associated with data from veterinary laboratory submissions, but no research has focused on how negative test results from a veterinary diagnostic laboratory data can be used to improve our knowledge of disease outbreaks. For example, if a diagnostic laboratory was seeing a disproportionate number of negative test results for a known disease could this information be an indication of a novel disease outbreak? The objective of this study was to determine the association between the porcine circovirus associated disease (PCVAD) outbreak in Ontario 2004–2006 and the results of porcine reproductive and respiratory syndrome virus (PPRSV) enzyme-linked immunosorbent assay (ELISA) and the results of PRRSV polymerase chain reaction (PCR) diagnostic tests requested by veterinarians. Results Retrospective data were collected from the Animal Health Laboratory (AHL) at the University of Guelph, Guelph, Ontario Canada and were comprised of weekly counts of PRRSV ELISA and PRRSV PCR diagnostic tests requested by swine practitioners from 2000–2007. The results of the PRRSV ELISA and PRRSV PCRs were analysed separately in two models using logistic regression with the dependent variables being: the weekly probability of PRRSV ELISA positivity, and the weekly probability of PRRSV PCR positivity, respectively. The weekly probability of PRRSV PCR positivity decreased during the PVCAD outbreak (OR=0.66, P=0.01). The weekly probability of PRRSV ELISA positivity was not associated with the PCVAD outbreak. Conclusions The results of this study showed that during the PCVAD outbreak in Ontario from December 2004-May 2006, the probability of a positive PRRSV PCR at the AHL decreased. We conclude that when a decrease in test positivity occurs for a known disease, it may suggest that a new

  2. Identifying an outbreak of a novel swine disease using test requests for porcine reproductive and respiratory syndrome as a syndromic surveillance tool.

    PubMed

    O'Sullivan, Terri L; Friendship, Robert M; Pearl, David L; McEwen, Beverly; Dewey, Catherine E

    2012-10-16

    Animal disease monitoring and surveillance are crucial for ensuring the health of animals, humans and the environment. Many studies have investigated the utility of monitoring syndromes associated with data from veterinary laboratory submissions, but no research has focused on how negative test results from a veterinary diagnostic laboratory data can be used to improve our knowledge of disease outbreaks. For example, if a diagnostic laboratory was seeing a disproportionate number of negative test results for a known disease could this information be an indication of a novel disease outbreak? The objective of this study was to determine the association between the porcine circovirus associated disease (PCVAD) outbreak in Ontario 2004-2006 and the results of porcine reproductive and respiratory syndrome virus (PPRSV) enzyme-linked immunosorbent assay (ELISA) and the results of PRRSV polymerase chain reaction (PCR) diagnostic tests requested by veterinarians. Retrospective data were collected from the Animal Health Laboratory (AHL) at the University of Guelph, Guelph, Ontario Canada and were comprised of weekly counts of PRRSV ELISA and PRRSV PCR diagnostic tests requested by swine practitioners from 2000-2007. The results of the PRRSV ELISA and PRRSV PCRs were analysed separately in two models using logistic regression with the dependent variables being: the weekly probability of PRRSV ELISA positivity, and the weekly probability of PRRSV PCR positivity, respectively. The weekly probability of PRRSV PCR positivity decreased during the PVCAD outbreak (OR=0.66, P=0.01). The weekly probability of PRRSV ELISA positivity was not associated with the PCVAD outbreak. The results of this study showed that during the PCVAD outbreak in Ontario from December 2004-May 2006, the probability of a positive PRRSV PCR at the AHL decreased. We conclude that when a decrease in test positivity occurs for a known disease, it may suggest that a new disease agent is emerging in the

  3. Topological Characteristics of the Hong Kong Stock Market: A Test-based P-threshold Approach to Understanding Network Complexity.

    PubMed

    Xu, Ronghua; Wong, Wing-Keung; Chen, Guanrong; Huang, Shuo

    2017-02-01

    In this paper, we analyze the relationship among stock networks by focusing on the statistically reliable connectivity between financial time series, which accurately reflects the underlying pure stock structure. To do so, we firstly filter out the effect of market index on the correlations between paired stocks, and then take a t-test based P-threshold approach to lessening the complexity of the stock network based on the P values. We demonstrate the superiority of its performance in understanding network complexity by examining the Hong Kong stock market. By comparing with other filtering methods, we find that the P-threshold approach extracts purely and significantly correlated stock pairs, which reflect the well-defined hierarchical structure of the market. In analyzing the dynamic stock networks with fixed-size moving windows, our results show that three global financial crises, covered by the long-range time series, can be distinguishingly indicated from the network topological and evolutionary perspectives. In addition, we find that the assortativity coefficient can manifest the financial crises and therefore can serve as a good indicator of the financial market development.

  4. Does market integration buffer risk, erode traditional sharing practices and increase inequality? A test among Bolivian forager-farmers

    PubMed Central

    Gurven, Michael; Jaeggi, Adrian V.; von Rueden, Chris; Hooper, Paul L.; Kaplan, Hillard

    2015-01-01

    Sharing and exchange are common practices for minimizing food insecurity in rural populations. The advent of markets and monetization in egalitarian indigenous populations presents an alternative means of managing risk, with the potential impact of eroding traditional networks. We test whether market involvement buffers several types of risk and reduces traditional sharing behavior among Tsimane Amerindians of the Bolivian Amazon. Results vary based on type of market integration and scale of analysis (household vs. village), consistent with the notion that local culture and ecology shape risk management strategies. Greater wealth and income were unassociated with the reliance on others for food, or on reciprocity, but wealth was associated with a greater proportion of food given to others (i.e., giving intensity) and a greater number of sharing partners (i.e., sharing breadth). Across villages, greater mean income was negatively associated with reciprocity, but economic inequality was positively associated with giving intensity and sharing breadth. Incipient market integration does not necessarily replace traditional buffering strategies but instead can often enhance social capital. PMID:26526638

  5. Topological Characteristics of the Hong Kong Stock Market: A Test-based P-threshold Approach to Understanding Network Complexity

    NASA Astrophysics Data System (ADS)

    Xu, Ronghua; Wong, Wing-Keung; Chen, Guanrong; Huang, Shuo

    2017-02-01

    In this paper, we analyze the relationship among stock networks by focusing on the statistically reliable connectivity between financial time series, which accurately reflects the underlying pure stock structure. To do so, we firstly filter out the effect of market index on the correlations between paired stocks, and then take a t-test based P-threshold approach to lessening the complexity of the stock network based on the P values. We demonstrate the superiority of its performance in understanding network complexity by examining the Hong Kong stock market. By comparing with other filtering methods, we find that the P-threshold approach extracts purely and significantly correlated stock pairs, which reflect the well-defined hierarchical structure of the market. In analyzing the dynamic stock networks with fixed-size moving windows, our results show that three global financial crises, covered by the long-range time series, can be distinguishingly indicated from the network topological and evolutionary perspectives. In addition, we find that the assortativity coefficient can manifest the financial crises and therefore can serve as a good indicator of the financial market development.

  6. Does market integration buffer risk, erode traditional sharing practices and increase inequality? A test among Bolivian forager-farmers.

    PubMed

    Gurven, Michael; Jaeggi, Adrian V; von Rueden, Chris; Hooper, Paul L; Kaplan, Hillard

    2015-08-01

    Sharing and exchange are common practices for minimizing food insecurity in rural populations. The advent of markets and monetization in egalitarian indigenous populations presents an alternative means of managing risk, with the potential impact of eroding traditional networks. We test whether market involvement buffers several types of risk and reduces traditional sharing behavior among Tsimane Amerindians of the Bolivian Amazon. Results vary based on type of market integration and scale of analysis (household vs. village), consistent with the notion that local culture and ecology shape risk management strategies. Greater wealth and income were unassociated with the reliance on others for food, or on reciprocity, but wealth was associated with a greater proportion of food given to others (i.e., giving intensity) and a greater number of sharing partners (i.e., sharing breadth). Across villages, greater mean income was negatively associated with reciprocity, but economic inequality was positively associated with giving intensity and sharing breadth. Incipient market integration does not necessarily replace traditional buffering strategies but instead can often enhance social capital.

  7. Topological Characteristics of the Hong Kong Stock Market: A Test-based P-threshold Approach to Understanding Network Complexity

    PubMed Central

    Xu, Ronghua; Wong, Wing-Keung; Chen, Guanrong; Huang, Shuo

    2017-01-01

    In this paper, we analyze the relationship among stock networks by focusing on the statistically reliable connectivity between financial time series, which accurately reflects the underlying pure stock structure. To do so, we firstly filter out the effect of market index on the correlations between paired stocks, and then take a t-test based P-threshold approach to lessening the complexity of the stock network based on the P values. We demonstrate the superiority of its performance in understanding network complexity by examining the Hong Kong stock market. By comparing with other filtering methods, we find that the P-threshold approach extracts purely and significantly correlated stock pairs, which reflect the well-defined hierarchical structure of the market. In analyzing the dynamic stock networks with fixed-size moving windows, our results show that three global financial crises, covered by the long-range time series, can be distinguishingly indicated from the network topological and evolutionary perspectives. In addition, we find that the assortativity coefficient can manifest the financial crises and therefore can serve as a good indicator of the financial market development. PMID:28145494

  8. [Effects of resting days on live poultry markets in controlling the avian influenza pollution].

    PubMed

    Liu, Hui; Chen, Zongqiu; Xiao, Xincai; Lu, Jianyun; Di, Biao; Li, Kuibiao; Wang, Hui; Luo, Lei; Yang, Zhicong

    2014-07-01

    To analyze the results of nine-round environmental specimen surveillance programs in five live poultry markets pre-, during and post the 'closing days' and to evaluate the effects of 'closing days' on live poultry markets regarding the control against avian influenza pollution. In January 2014, control measures including culling poultry, completely cleaning and disinfecting and a 'three-day-closing' measure were conducted in five live poultry markets which were found positive for H7N9 nucleic acid in the 1(st) round environmental specimen surveillance program. Second surveillance program was conducted after a thorough disinfection campaign was launched. Several times surveillance were conducted in one week, after the markets were reopened. RT-PCR was used to test the nucleic acid of HA, H5, H7 and H9 viruses. 654 specimens from the environment were collected and tested. During the first round surveillance program, positive rates for influenza A and H5/H7/H9 nucleic acid of poultry stalls appeared to be 94.44% and 61.11% respectively. The positive rates of poultry stalls reduced to 0 after the disinfection campaign but increased again after the markets reopened. The positive rate for influenza A of poultry stalls slightly increased from 50.00% in the third surveillance to 72.22% in the ninth surveillance (P > 0.05). The positive rate for H5/H7/H9 of poultry stalls showed a significantly increasing trend, from 0 in the third surveillance to 44.44% in the ninth surveillance (P < 0.01). The positive rates for influenza A and H5/H7/H9 nucleic acid of specimens were 28.89% and 17.78% respectively. The positive rate of specimens reduced to 0 after disinfection while increased again after reopening of the markets. The positive rate for influenza A of specimens slightly increased from 19.67% in the third surveillance to 27.54% in the ninth surveillance programs (P > 0.05). The positive rate for H5/H7/H9 of specimen showed a significant increasing trend, from 0 in the third

  9. A cross-section test of Cobb-Douglass production function between market capitalization and GDP

    NASA Astrophysics Data System (ADS)

    Avakian, Adam; Podobnik, Boris; Stanley, H. Eugene

    2012-02-01

    Most classical economic theories imply that both (a) economies with lower output (GDP) per person tend to grow faster in per capita terms and (b) economies with lower capital per person tend to grow faster in per capita terms. It is well-known that the former was found to be wrong. Taking market capitalization as a proxy for physical capital, we analyze a cohort of countries over a 17-year period (1994-2010) and we find the latter statement in agreement with empirical data implying a contradictive result that while capital data worldwide tend to converge, GDP data tend to diverge. However, for the countries analyzed, for which we have both market capitalization and GDP data, we find that even economies with lower output (GDP) per person tend to grow faster in per capita terms. The result that for all countries one obtains divergence while for a group of countries having both market capitalization and GDP data we have convergence is in contrast with the refutation of (a) but our results only apply to countries that have an exchange market, and are thus participating in globalization, indicating the convergent effect of globalization.

  10. Marketing Training

    NASA Technical Reports Server (NTRS)

    Leonard, Eric

    1998-01-01

    All of our ideas have been field tested and have proven effective in our environment. Our objectives are: We will share our ideas about marketing training and what we've implemented at Michoud Space Systems. You will go away with at least one new idea or insight about how to more effectively market your training.

  11. Markets for compost

    SciTech Connect

    Not Available

    1993-11-01

    Table of Contents: Introduction; Characteristics and Benefits of Compost and Competing/Complementary Products; Compost Uses and Markets; Factors Pertinent to Developing Compost Markets; Compost Specifications; Compost Testing Requirements; Compost Distribution; Compost Policies; Economic and Noneconomic Barriers to Developing Compost Markets; Strategies to Mitigate/Overcome Barriers to Developing Compost Markets; and Examples of Existing Programs and Markets (as of 1989).

  12. Community Laboratory Testing for Cryptosporidium: Multicenter Study Retesting Public Health Surveillance Stool Samples Positive for Cryptosporidium by Rapid Cartridge Assay with Direct Fluorescent Antibody Testing

    PubMed Central

    Roellig, Dawn M.; Yoder, Jonathan S.; Madison-Antenucci, Susan; Robinson, Trisha J.; Van, Tam T.; Collier, Sarah A.; Boxrud, Dave; Monson, Timothy; Bates, Leigh Ann; Blackstock, Anna J.; Shea, Shari; Larson, Kirsten; Xiao, Lihua; Beach, Michael

    2017-01-01

    Cryptosporidium is a common cause of sporadic diarrheal disease and outbreaks in the United States. Increasingly, immunochromatography-based rapid cartridge assays (RCAs) are providing community laboratories with a quick cryptosporidiosis diagnostic method. In the current study, the Centers for Disease Control and Prevention (CDC), the Association of Public Health Laboratories (APHL), and four state health departments evaluated RCA-positive samples obtained during routine Cryptosporidium testing. All samples underwent “head to head” re-testing using both RCA and direct fluorescence assay (DFA). Community level results from three sites indicated that 54.4% (166/305) of Meridian ImmunoCard STAT! positives and 87.0% (67/77) of Remel Xpect positives were confirmed by DFA. When samples were retested by RCA at state laboratories and compared with DFA, 83.3% (155/186) of Meridian ImmunoCard STAT! positives and 95.2% (60/63) of Remel Xpect positives were confirmed. The percentage of confirmed community results varied by site: Minnesota, 39.0%; New York, 63.9%; and Wisconsin, 72.1%. The percentage of confirmed community results decreased with patient age; 12.5% of community positive tests could be confirmed by DFA for patients 60 years of age or older. The percentage of confirmed results did not differ significantly by sex, storage temperature, time between sample collection and testing, or season. Findings from this study demonstrate a lower confirmation rate of community RCA positives when compared to RCA positives identified at state laboratories. Elucidating the causes of decreased test performance in order to improve overall community laboratory performance of these tests is critical for understanding the epidemiology of cryptosporidiosis in the United States (US). PMID:28085927

  13. Community Laboratory Testing for Cryptosporidium: Multicenter Study Retesting Public Health Surveillance Stool Samples Positive for Cryptosporidium by Rapid Cartridge Assay with Direct Fluorescent Antibody Testing.

    PubMed

    Roellig, Dawn M; Yoder, Jonathan S; Madison-Antenucci, Susan; Robinson, Trisha J; Van, Tam T; Collier, Sarah A; Boxrud, Dave; Monson, Timothy; Bates, Leigh Ann; Blackstock, Anna J; Shea, Shari; Larson, Kirsten; Xiao, Lihua; Beach, Michael

    2017-01-01

    Cryptosporidium is a common cause of sporadic diarrheal disease and outbreaks in the United States. Increasingly, immunochromatography-based rapid cartridge assays (RCAs) are providing community laboratories with a quick cryptosporidiosis diagnostic method. In the current study, the Centers for Disease Control and Prevention (CDC), the Association of Public Health Laboratories (APHL), and four state health departments evaluated RCA-positive samples obtained during routine Cryptosporidium testing. All samples underwent "head to head" re-testing using both RCA and direct fluorescence assay (DFA). Community level results from three sites indicated that 54.4% (166/305) of Meridian ImmunoCard STAT! positives and 87.0% (67/77) of Remel Xpect positives were confirmed by DFA. When samples were retested by RCA at state laboratories and compared with DFA, 83.3% (155/186) of Meridian ImmunoCard STAT! positives and 95.2% (60/63) of Remel Xpect positives were confirmed. The percentage of confirmed community results varied by site: Minnesota, 39.0%; New York, 63.9%; and Wisconsin, 72.1%. The percentage of confirmed community results decreased with patient age; 12.5% of community positive tests could be confirmed by DFA for patients 60 years of age or older. The percentage of confirmed results did not differ significantly by sex, storage temperature, time between sample collection and testing, or season. Findings from this study demonstrate a lower confirmation rate of community RCA positives when compared to RCA positives identified at state laboratories. Elucidating the causes of decreased test performance in order to improve overall community laboratory performance of these tests is critical for understanding the epidemiology of cryptosporidiosis in the United States (US).

  14. Minuteman 3, stage 3 surveillance

    NASA Astrophysics Data System (ADS)

    Davis, R.; Porter, L. C., Jr.

    1986-01-01

    The program effort during this reporting period consisted of laboratory testing of both the Morton Thiokol, Inc./ASPC Minuteman 3 Third Stage Surveillance components and material samples. In addition, bondline aging testing and analysis using samples from previously dissected motors were accomplished. In support of the program, all flight and static tests, for both First and Third Stage Minuteman motors, were reviewed and tabulated for incorporation into reliability and motor historical records.

  15. General Medical Surveillance Program

    NASA Technical Reports Server (NTRS)

    1993-01-01

    Background on the General Medical Surveillance Program at LeRC is presented. The purpose of the General Medical Surveillance Program at LeRC is outlined, and the specifics of the program are discussed.

  16. Using genetic algorithms to search for an optimal portfolio strategy and test market efficiency

    NASA Astrophysics Data System (ADS)

    Xi, Haowen; Mandere, Edward

    2008-03-01

    In this numerical experiment we used genetic algorithms to search for an optimal portfolio investment strategy. The algorithm involves having a ``manager'' who divides his capital among various ``experts'' each of whom has a simple fixed investment strategy. The expert strategies act like population of genes which experiencing selection, mutation and crossover during evolution process. The genetic algorithm was run on actual portfolio with stock data (DowJones 30 stocks). We found that the genetic algorithm overwhelmingly selected optimal strategy that closely resembles a simple buy and hold portfolio, that is, evenly distribute the capital among all stocks. This study shows that market is very efficient, and one possible practical way to gauge market efficiency is to measure the difference between an optimal portfolio return and a simple buy and hold portfolio return.

  17. The Hurst exponent over time: testing the assertion that emerging markets are becoming more efficient

    NASA Astrophysics Data System (ADS)

    Cajueiro, Daniel O.; Tabak, Benjamin M.

    2004-05-01

    This paper is concerned with the assertion found in the financial literature that emerging markets are becoming more efficient over time. To verify whether this assertion is true or not, we propose the calculation of the Hurst exponent over time using a time window with 4 years of data. The data used here comprises the bulk of emerging markets for Latin America and Asia. Our empirical results show that this assertion seems to be true for most countries, but it does not hold for countries such as Brazil, The Philippines and Thailand. Moreover, in order to check whether or not these results depend on the short term memory and the volatility of returns common in such financial asset return data, we filter the data by an AR-GARCH procedure and present the Hurst exponents for this filtered data.

  18. Confidentiality Concerns Raised by DNA-Based Tests in the Market-Driven Managed Care Setting

    SciTech Connect

    Kotval, Jeroo S.

    2006-07-28

    In a policy climate where incentives to cherry pick are minimized, Managed Care Organizations can implement practices that safeguard medical privacy to the extent that data is protected from falling into the hands of third parties who could misuse it to discriminate. To the extent that these practices have been codified into the regulatory Network of the Health Insurance Portability and Accountability Act (HIPAA) Consumers may be able to rest easy about their genetic data being revealed to third parties who may discriminate. However, there are limitations to the use of policy instruments to prevent the discrimination of an entire genre of clients by market driven managed care organizations. Policy measures, to assure that knowledge of genetic conditions and their future costs would not be used by market driven managed care organizations to implement institutional policies and products that would implicitly discriminate against a genre of clients with genetic conditions, present difficulties.

  19. Instrumental Surveillance of Water Quality.

    ERIC Educational Resources Information Center

    Miller, J. A.; And Others

    The role analytical instrumentation performs in the surveillance and control of the quality of water resources is reviewed. Commonly performed analyses may range from simple tests for physical parameters to more highly sophisticated radiological or spectrophotometric methods. This publication explores many of these types of water quality analyses…

  20. Instrumental Surveillance of Water Quality.

    ERIC Educational Resources Information Center

    Miller, J. A.; And Others

    The role analytical instrumentation performs in the surveillance and control of the quality of water resources is reviewed. Commonly performed analyses may range from simple tests for physical parameters to more highly sophisticated radiological or spectrophotometric methods. This publication explores many of these types of water quality analyses…

  1. Public participation in radiological surveillance.

    PubMed

    Hanf, R W; Schreckhise, R G; Patton, G W; Poston, T M; Jaquish, R E

    1997-10-01

    In 1989, Pacific Northwest National Laboratory developed a program, for the U.S. Department of Energy, to involve local citizens in environmental surveillance at the Hanford Site. The Community-Operated Environmental Surveillance Program was patterned after similar community-involvement efforts at the Nevada Test Site and the Three Mile Island nuclear facility. Its purpose is to increase the flow of information to the public, thereby enhancing the public's awareness and understanding of surveillance activities. The program consists of two components: radiological air monitoring at nine offsite locations and agricultural product sampling at selected locations near the site. At each air-monitoring station, two local school teachers collect air particulate samples and operate equipment to monitor ambient radiation levels. Atmospheric tritium samples (as water vapor) are also collected at some locations. Four of the air-monitoring stations include large, colorful informational displays for public viewing. These displays provide details on station equipment, sample types, and sampling purposes. Instruments in the displays also monitor, record, and show real-time ambient radiation readings (measured with a pressurized ionization chamber) and meteorological conditions. Agricultural products, grown primarily by middle-school-aged students, are obtained from areas downwind of the site. Following analysis of these samples, environmental surveillance staff visit the schools to discuss the results with the students and their teachers. The data collected by these air and agricultural sampling efforts are summarized with other routinely collected sitewide surveillance data and reported annually in the Hanford Site environmental report.

  2. Disintegration Test of Health Food Products Containing Ginkgo Biloba L. or Vitex Agnus-Castus L. in the Japanese Market.

    PubMed

    Sato-Masumoto, Naoko; Masada, Sayaka; Takahashi, Satoshi; Terasaki, Sachiko; Yokota, Yoichi; Hakamatsuka, Takashi; Goda, Yukihiro

    2015-04-23

    For many years now, a number of Western herbs have been widely used in health food products in Japan and as pharmaceuticals in Europe. There are few or no mandated criteria concerning the quality of these herbal health food products, thus clarification is warranted. Here, we performed disintegration tests of 26 pharmaceutical and health food products containing the Western herbs ginkgo leaf and chaste tree fruit, in accord with the Japanese Pharmacopoeia. All eight pharmaceutical herbal products found in the European market completely disintegrated within the defined test time, and 11 of the 18 tested herbal products distributed as health foods in Japan disintegrated. Among the incompatible products identified in the Pharmacopoeia test, some products remained intact after incubation in water for 60 min. To ensure the efficacy of Western herbal products sold as health food in Japan, quality control, including disintegration, is therefore recommended, even though these products are not regulated under the Pharmaceutical Affairs Law.

  3. Disintegration Test of Health Food Products Containing Ginkgo Biloba L. or Vitex Agnus-Castus L. in the Japanese Market

    PubMed Central

    Sato-Masumoto, Naoko; Masada, Sayaka; Takahashi, Satoshi; Terasaki, Sachiko; Yokota, Yoichi; Hakamatsuka, Takashi; Goda, Yukihiro

    2015-01-01

    For many years now, a number of Western herbs have been widely used in health food products in Japan and as pharmaceuticals in Europe. There are few or no mandated criteria concerning the quality of these herbal health food products, thus clarification is warranted. Here, we performed disintegration tests of 26 pharmaceutical and health food products containing the Western herbs ginkgo leaf and chaste tree fruit, in accord with the Japanese Pharmacopoeia. All eight pharmaceutical herbal products found in the European market completely disintegrated within the defined test time, and 11 of the 18 tested herbal products distributed as health foods in Japan disintegrated. Among the incompatible products identified in the Pharmacopoeia test, some products remained intact after incubation in water for 60 min. To ensure the efficacy of Western herbal products sold as health food in Japan, quality control, including disintegration, is therefore recommended, even though these products are not regulated under the Pharmaceutical Affairs Law. PMID:28930200

  4. AIDS-case surveillance.

    PubMed

    Lal, S; Khodakevich, L; Sengupta, D

    1994-01-01

    In 1991 in India, the Ministry of Health realized that the diagnostic and reporting network for AIDS cases was inadequate as AIDS cases grew and that the establishment of specialized AIDS units in hospitals was not the best strategy. It decided to integrate AIDS diagnostic and management facilities into primary health services. It would arrange training for 1 physician from each district and peripheral hospital, private hospital, and inpatient service of other medical institutions in AIDS diagnosis and management. These physicians would then train others in the clinical diagnosis and management of AIDS cases. The physicians would use the World Health Organization [WHO] case definition of AIDS supported by HIV serological test results. All AIDS cases would be transferred to the Medical College Hospitals of the States and Union Territories (UTs), regional hospitals, and perhaps some private hospitals. Between May 1986 and October 1993, India had 459 AIDS cases reported from 19 States and UTs, especially the States of Tamil Nadul and Maharashtra. This AIDS case surveillance system should motivate political will, describe the underlying and preceding HIV epidemic, and contribute to the understanding of current and future course of the epidemic. Thus, it will guide decision makers to develop sound preventive strategies, to plan health care, and to evaluate interventions. The surveillance system's target population is all outpatients and inpatients at medical institutions. During 1993-1994, 1000 hospitals should make up the network of referral institutions. AIDS case surveillance coordinators (ASCs) at each institution form the basis of the network. The individual case record of each suspected AIDS case will have details on his/her life and medical history. Records of confirmed cases will be sent to State ASCs who will compile them for the National AIDS Control Organisation. After 3-4 year of training and practice in AIDS diagnosis and reporting, AIDS reporting will be

  5. POLE and POLD1 mutations in 529 kindred with familial colorectal cancer and/or polyposis: review of reported cases and recommendations for genetic testing and surveillance

    PubMed Central

    Bellido, Fernando; Pineda, Marta; Aiza, Gemma; Valdés-Mas, Rafael; Navarro, Matilde; Puente, Diana A.; Pons, Tirso; González, Sara; Iglesias, Silvia; Darder, Esther; Piñol, Virginia; Soto, José Luís; Valencia, Alfonso; Blanco, Ignacio; Urioste, Miguel; Brunet, Joan; Lázaro, Conxi; Capellá, Gabriel; Puente, Xose S.; Valle, Laura

    2016-01-01

    Purpose: Germ-line mutations in the exonuclease domains of POLE and POLD1 have been recently associated with polyposis and colorectal cancer (CRC) predisposition. Here, we aimed to gain a better understanding of the phenotypic characteristics of this syndrome to establish specific criteria for POLE and POLD1 mutation screening and to help define the clinical management of mutation carriers. Genet Med 18 4, 325–332. Methods: The exonuclease domains of POLE and POLD1 were studied in 529 kindred, 441 with familial nonpolyposis CRC and 88 with polyposis, by using pooled DNA amplification and massively parallel sequencing. Genet Med 18 4, 325–332. Results: Seven novel or rare genetic variants were identified. In addition to the POLE p.L424V recurrent mutation in a patient with polyposis, CRC and oligodendroglioma, six novel or rare POLD1 variants (four of them, p.D316H, p.D316G, p.R409W, and p.L474P, with strong evidence for pathogenicity) were identified in nonpolyposis CRC families. Phenotypic data from these and previously reported POLE/POLD1 carriers point to an associated phenotype characterized by attenuated or oligo-adenomatous colorectal polyposis, CRC, and probably brain tumors. In addition, POLD1 mutations predispose to endometrial and breast tumors. Genet Med 18 4, 325–332. Conclusion: Our results widen the phenotypic spectrum of the POLE/POLD1-associated syndrome and identify novel pathogenic variants. We propose guidelines for genetic testing and surveillance recommendations. Genet Med 18 4, 325–332. PMID:26133394

  6. Should quality goals be defined for multicenter laboratory testing? Lessons learned from a pilot survey on a national surveillance program for diabetes.

    PubMed

    Wang, Limin; Mo, Nanxun; Pang, Richard; Deng, Qian; Liu, Yong; Hu, Yan; Hu, Chaohui; Wang, Linhong

    2016-04-01

    Robust laboratory protocols and stringent quality control (QC) procedures are essential for meaningful collection of data from multiple sites in large-scale population-based studies. Failure to design and implement an effective QC program not only adversely affects the scientific outcome, but also affects public confidence in the acceptability of the data. A pilot survey was conducted to assess the analytical performance of multicenter plasma glucose measurements in a national surveillance program for diabetes in China. Quality goals of the imprecision in terms of coefficient of variation (CV) and total analytical error (TEa) were defined based on the Clinical Laboratory Improvement Amendments (CLIA) criteria for acceptable performance of proficiency testing (PT) for plasma glucose using commercial QC preparations. A web-based internal QC (IQC) program was established to monitor the analytical performance of the 302 centers participating in the survey. The participation rate was 96% (289/302). Statistical analysis showed that the percentage of centers meeting the acceptable specifications of CV ≤5.0% and TEa ≤10% using the CLIA PT criteria was 91.7% while 76.4% of laboratories achieved the goals for desirable performance of CV ≤2.9% and TEa ≤6.9%, as proposed by the Laboratory Medicine Practice Guidelines for the management of diabetes mellitus based on biological criteria. Communications and training are important in ensuring the data integrity of multicenter population-based studies. Performance verification and IQC programs should be implemented to help identify centers that can fulfill the eligibility criteria to perform laboratory analyses. © The Author 2016. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

  7. Surveillance after endovascular aortic repair.

    PubMed

    Zaiem, Feras; Almasri, Jehad; Tello, Mouaffaa; Prokop, Larry J; Chaikof, Elliot L; Murad, Mohammad Hassan

    2017-06-26

    The objective of this systematic review and meta-analysis was to evaluate the optimal modality and frequency of surveillance after endovascular aortic repair (EVAR) in adult patients with abdominal aortic aneurysms. We searched for studies of post-EVAR surveillance in MEDLINE In-Process & Other Non-Indexed Citations, MEDLINE, Embase, Cochrane Database of Systematic Reviews, and Scopus through May 10, 2016. The outcomes of interest were endoleaks, mortality, limb ischemia, renal complications, late rupture, and aneurysm-related mortality. Outcomes were pooled using a random-effects model and were reported as incidence rate and 95% confidence interval. Of 1099 candidate references, we included 6 meta-analyses and 52 observational studies. Complication rates were common after EVAR, particularly in the first year. Magnetic resonance imaging had a higher detection rate of endoleaks than computed tomography angiography. Doppler ultrasound had lower diagnostic accuracy, whereas contrast-enhanced ultrasound was likely to be as sensitive as computed tomography angiography. The highest endoleak detection rates were in surveillance approaches that used combined tests. There were no studies that compared different surveillance intervals to determine optimal intervals; however, most studies reported detection rates of patient-important outcomes at 1, 6, 12, 24, 36, 48, and 60 months. Data were insufficient to provide comparative inferences about the best strategy to reduce the risk of patient-important outcomes, such as mortality, limb ischemia, rupture, and renal complications. Several tests with reasonable diagnostic accuracy are available for surveillance after EVAR. The available evidence suggests a high complication rate, particularly in the first year, and provides a rationale for surveillance. Published by Elsevier Inc.

  8. Stent thrombosis and bleeding complications after implantation of sirolimus-eluting coronary stents in an unselected worldwide population: a report from the e-SELECT (Multi-Center Post-Market Surveillance) registry.

    PubMed

    Urban, Philip; Abizaid, Alexandre; Banning, Adrian; Bartorelli, Antonio L; Baux, Ana Cebrian; Džavík, Vladimír; Ellis, Stephen; Gao, Runlin; Holmes, David; Jeong, Myung Ho; Legrand, Victor; Neumann, Franz-Josef; Nyakern, Maria; Spaulding, Christian; Worthley, Stephen

    2011-03-29

    The aim of this study was to ascertain the 1-year incidence of stent thrombosis (ST) and major bleeding (MB) in a large, unselected population treated with sirolimus-eluting stents (SES). Stent thrombosis and MB are major potential complications of drug-eluting stent implantation. Their relative incidence and predisposing factors among large populations treated worldwide are unclear. The SES were implanted in 15,147 patients who were entered in a multinational registry. We analyzed the incidence of: 1) definite and probable ST as defined by the Academic Research Consortium; and 2) MB, with the STEEPLE (Safety and efficacy of Enoxaparin in PCI) definition, together with their relation to dual antiplatelet therapy (DAPT) and to 1-year clinical outcomes. The mean age of the sample was 62 ± 11 years, 30.4% were diabetic, 10% had a Charlson comorbidity index ≥3, and 44% presented with acute coronary syndrome or myocardial infarction. At 1 year, the reported compliance with DAPT as recommended by the European Society of Cardiology guidelines was 86.3%. Adverse event rates were: ST 1.0%, MB 1.0%, mortality 1.7%, myocardial infarction 1.9%, and target lesion revascularization 2.3%. Multivariate analysis identified 9 correlates of ST and 4 correlates of MB. Advanced age and a high Charlson index were associated with an increased risk of both ST and MB. After ST, the 7-day and 1-year all-cause mortality was 30% and 35%, respectively, versus 1.5% and 10% after MB. Only 2 of 13,749 patients (0.015%) experienced both MB and ST during the entire 1-year follow-up period. In this worldwide population treated with ≥1 SES, the reported compliance with DAPT was good, and the incidence of ST and MB was low. Stent thrombosis and MB very rarely occurred in the same patient. (The e-SELECT Registry: a Multicenter Post-Market Surveillance; NCT00438919). Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  9. The sirolimus-eluting Cypher Select coronary stent for the treatment of bare-metal and drug-eluting stent restenosis: insights from the e-SELECT (Multicenter Post-Market Surveillance) registry.

    PubMed

    Abizaid, Alexandre; Costa, J Ribamar; Banning, Adrian; Bartorelli, Antonio L; Dzavik, Vladimir; Ellis, Stephen; Gao, Runlin; Holmes, David R; Jeong, Muyng Ho; Legrand, Victor; Neumann, Franz-Josef; Nyakern, Maria; Orlick, Amy; Spaulding, Christian; Worthley, Stephen; Urban, Philip M

    2012-01-01

    This study sought to compare the 1-year safety and efficacy of Cypher Select or Cypher Select Plus (Cordis Corporation, Bridgewater, New Jersey) sirolimus-eluting stents (SES) with the treatment of bare-metal stents (BMS) and drug-eluting stent (DES) in-stent restenosis (ISR) in nonselected, real-world patients. There is paucity of consistent data on DES for the treatment of ISR, especially, DES ISR. The e-SELECT (Multicenter Post-Market Surveillance) registry is a Web-based, multicenter and international registry encompassing virtually all subsets of patients and lesions treated with at least 1 SES during the period from 2006 to 2008. We enrolled in this pre-specified subanalysis all patients with at least 1 clinically relevant BMS or DES ISR treated with SES. Primary endpoint was major adverse cardiac events and stent thrombosis rate at 1 year. Of 15,147 patients enrolled, 1,590 (10.5%) presented at least 1 ISR (BMS group, n = 1,235, DES group, n = 355). Patients with DES ISR had higher incidence of diabetes (39.4% vs. 26.9%, p < 0.001), renal insufficiency (5.8% vs. 2.3%, p = 0.003), and prior coronary artery bypass graft (20.5% vs. 11.8%, p < 0.001). At 1 year, death (1.4% for BMS vs. 2.1% for DES, p = 0.3) and myocardial infarction (2.4% for BMS and 3.3% for DES, p = 0.3) rates were similar, whereas ischemia-driven target lesion revascularization and definite/probable late stent thrombosis were higher in patients with DES ISR (6.9% vs. 3.1%, p = 0.003, and 1.8% vs. 0.5%, p = 0.04, respectively). Use of SES for either BMS or DES ISR treatment is safe and associated with low target lesion revascularization recurrence and no apparent safety concern. Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  10. The benefits of the 3T3 NRU test in the safety assessment of cosmetics: long-term experience from pre-marketing testing in the Czech Republic.

    PubMed

    Jírová, D; Kejlová, K; Brabec, M; Bendová, H; Kolárová, H

    2003-01-01

    We have introduced the 3T3 NRU cytotoxicity test for methodological, economical and ethical reasons as a regular part of tier pre-marketing testing to assess local tolerance of raw materials for cosmetics, household chemicals and final cosmetic products. Using the 3T3 cell line according to the standard INVITTOX protocol No.64 (NRU Assay) the borderline concentration, relevant to the highest tolerated dose, is determined for each material. The toxic effect is reached at different concentration levels specific for individual cosmetics categories, depending on their chemical characteristics. Typical ranges of cytotoxicity for specific categories of cosmetics were established after testing of hundreds of materials. The range lies between 1 microg/ml (anti-dandruff shampoos), up to 2000 microg/ml (toothpastes and mouthwashes). The 3T3 NRU cytotoxicity test is a sensitive tool able to identify more aggressive products, that are also more likely to evoke irritation in human skin. It was even possible to detect protective effects of one natural herbal ingredient. The comparative study of cytotoxicity test results and human patch test results from a group of essential oils is presented. Cytotoxicity tests represent a highly ethical approach for estimation of irritancy. On the basis of in vitro test results suggesting low risk we can proceed to confirmatory tests in human volunteers.

  11. Tests of scaling and universality of the distributions of trade size and share volume: Evidence from three distinct markets

    NASA Astrophysics Data System (ADS)

    Plerou, Vasiliki; Stanley, H. Eugene

    2007-10-01

    Empirical evidence for scale-invariant distributions in financial data has attracted the research interest of physicists. While the power-law tails of the distribution of stock returns P{R>x}˜x-ζR are becoming increasingly well documented, less understood are the statistics of other closely related microstructural variables such as qi , the number of shares exchanged in trade i (termed the trade size) and QΔt(t)=∑i=1Nqi , the total number of shares exchanged as a result of the N=NΔt trades occurring in a time interval Δt (termed share volume). We analyze the statistical properties of trade size q≡qi and share volume Q≡QΔt(t) by analyzing trade-by-trade data from three large databases representing three distinct markets: (i) 1000 major U.S. stocks for the 2-y period 1994-1995, (ii) 85 major U.K. stocks for the 2-y period 2001-2002, and (iii) 13 major Paris Bourse stocks for the 4.5-y period 1994-1999. We find that, for all three markets analyzed, the cumulative distribution of trade size displays a power-law tail P(q>x)˜x-ζq with exponent ζq<2 within the Lévy stable domain. Our analysis of the exponent estimates of ζq suggests that the exponent value is universal in the following respects: (a) ζq is consistent across stocks within each of the three markets analyzed, and also across different markets, and (b) ζq does not display any systematic dependence on market capitalization or industry sector. We next analyze the distributions of share volume QΔt over fixed time intervals and find that for all three markets P{Q>x}˜x-ζQ with exponent ζQ<2 within the Lévy stable domain. To test the validity for Δt=1day of the power-law distributions found from tick-by-tick data, we analyze a fourth large database containing daily U.S. data, and confirm a value for the exponent ζQ within the Lévy stable domain.

  12. Urine drug testing of chronic pain patients. V. Prevalence of propoxyphene following its withdrawal from the United States market.

    PubMed

    Puet, Brandi; DePriest, Anne; Knight, Julie; Heltsley, Rebecca; Black, David L; Caplan, Yale H; Cone, Edward J

    2013-01-01

    Propoxyphene is an opioid analgesic that was surrounded by controversy concerning its safety and efficacy during its lifespan in the US market. Propoxyphene was withdrawn in November of 2010 from the US market and is still being detected one year post-withdrawal in urine specimens from the pain management population. In this study, the prevalence of propoxyphene was determined in a total of 417,914 urine specimens collected from 630 clinics involved in pain management located in 24 states during the period of January 1, 2010, through December 31, 2011. Propoxyphene and norpropoxyphene were measured in urine by a validated liquid chromatography-tandem mass spectrometry procedure with a lower limit of quantitation of 50 ng/mL. The positivity rate for propoxyphene prevalence declined sharply between November and December of 2010 and further declined at a gradual rate, ending in a prevalence of 0.27% (one out of every 370 specimens, n = 25,658) for the month of December 2011. The presented data provide evidence of the dramatic decline in the use of propoxyphene products since their removal from the medical market, and may be beneficial to US urine drug testing programs determining the need for continual monitoring of propoxyphene levels.

  13. Validity of urinary monoamine assay sales under the “spot baseline urinary neurotransmitter testing marketing model”

    PubMed Central

    Hinz, Marty; Stein, Alvin; Uncini, Thomas

    2011-01-01

    Spot baseline urinary monoamine assays have been used in medicine for over 50 years as a screening test for monoamine-secreting tumors, such as pheochromocytoma and carcinoid syndrome. In these disease states, when the result of a spot baseline monoamine assay is above the specific value set by the laboratory, it is an indication to obtain a 24-hour urine sample to make a definitive diagnosis. There are no defined applications where spot baseline urinary monoamine assays can be used to diagnose disease or other states directly. No peer-reviewed published original research exists which demonstrates that these assays are valid in the treatment of individual patients in the clinical setting. Since 2001, urinary monoamine assay sales have been promoted for numerous applications under the “spot baseline urinary neurotransmitter testing marketing model”. There is no published peer-reviewed original research that defines the scientific foundation upon which the claims for these assays are made. On the contrary, several articles have been published that discredit various aspects of the model. To fill the void, this manuscript is a comprehensive review of the scientific foundation and claims put forth by laboratories selling urinary monoamine assays under the spot baseline urinary neurotransmitter testing marketing model. PMID:21912487

  14. Intussusception surveillance in a rural demographic surveillance area in bangladesh.

    PubMed

    Zaman, Khalequ; Breiman, Robert F; Yunus, Md; Arifeen, Shams E; Mahmud, Asheque; Chowdhury, H R; Luby, Stephen P

    2009-11-01

    Rotavirus is the leading cause of diarrhea-related morbidity and mortality in developing countries, including Bangladesh. The licensed vaccine Rotashield was withdrawn from the market because of an increased risk of intussusception. This study was undertaken to estimate the background incidence rates of intussusception among children aged <2 years, using retrospective and prospective studies in a rural demographic surveillance area in Bangladesh. All hospital charts of children aged <2 years who presented to the Matlab Hospital and 2 other treatment centers of the International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B), during January 2001-August 2004 were reviewed retrospectively. A prospective surveillance was performed from August 2004 through December 2006 at the 3 treatment centers of ICDDR,B serving Matlab, 4 district and subdistrict government hospitals, and 3 district-based private clinics, to determine population-based rates of intussusception with use of Brighton Collaboration case definitions. All suspected cases of intussusception were referred to the Matlab Hospital by community health research workers for further assessment by a trained medical officer, including performance of an ultrasound examination. In total, 2856 charts of children aged <2 years were reviewed retrospectively, and 4 probable cases and 19 possible cases of intussusception were identified. In the prospective surveillance, of 1508 potential cases, including 41 referred by community health research workers, only 2 cases met the case definition of probable intussusception, and 1 case met the definition of possible intussusception. A total of 123 patients had ultrasound examinations performed. The population-based rates of probable and possible cases of intussusception among children aged <2 years were 0-17.8 and 17.7-81.7 cases per 100,000 children per year, respectively. In the retrospective and prospective surveillance, the rates were 0-18.7 and 0-97 cases per 100

  15. The U.S.-Mexico Border Infectious Disease Surveillance Project: Establishing Binational Border Surveillance

    PubMed Central

    Waterman, Stephen; Lucas, Carlos Alvarez; Falcon, Veronica Carrion; Morales, Pablo Kuri; Lopez, Luis Anaya; Peter, Chris; Gutiérrez, Alejandro Escobar; Gonzalez, Ernesto Ramirez; Flisser, Ana; Bryan, Ralph; Valle, Enrique Navarro; Rodriguez, Alfonso; Hernandez, Gerardo Alvarez; Rosales, Cecilia; Ortiz, Javier Arias; Landen, Michael; Vilchis, Hugo; Rawlings, Julie; Leal, Francisco Lopez; Ortega, Luis; Flagg, Elaine; Conyer, Roberto Tapia; Cetron, Martin

    2003-01-01

    In 1997, the Centers for Disease Control and Prevention, the Mexican Secretariat of Health, and border health officials began the development of the Border Infectious Disease Surveillance (BIDS) project, a surveillance system for infectious diseases along the U.S.-Mexico border. During a 3-year period, a binational team implemented an active, sentinel surveillance system for hepatitis and febrile exanthems at 13 clinical sites. The network developed surveillance protocols, trained nine surveillance coordinators, established serologic testing at four Mexican border laboratories, and created agreements for data sharing and notification of selected diseases and outbreaks. BIDS facilitated investigations of dengue fever in Texas-Tamaulipas and measles in California–Baja California. BIDS demonstrates that a binational effort with local, state, and federal participation can create a regional surveillance system that crosses an international border. Reducing administrative, infrastructure, and political barriers to cross-border public health collaboration will enhance the effectiveness of disease prevention projects such as BIDS. PMID:12533288

  16. The Impact of Testing Frequency on Student Performance in a Marketing Course

    ERIC Educational Resources Information Center

    Kling, Nathan; McCorkle, Denny; Miller, Chip; Reardon, James

    2005-01-01

    Testing frequency has long been examined in the social sciences as an antecedent to student performance in the classroom. However, after nearly 70 years of study, the results are inconclusive. Given the developments in computerized testing over the last decade, professors now have the ability to create and conduct frequent tests without severely…

  17. Higher vaccine effectiveness in seasons with predominant circulation of seasonal influenza A(H1N1) than in A(H3N2) seasons: test-negative case-control studies using surveillance data, Spain, 2003-2011.

    PubMed

    Savulescu, Camelia; Jiménez-Jorge, Silvia; Delgado-Sanz, Concha; de Mateo, Salvador; Pozo, Francisco; Casas, Inmaculada; Larrauri, Amparo

    2014-07-31

    We used data provided by the Spanish influenza surveillance system to measure seasonal influenza vaccine effectiveness (VE) against medically attended cases, laboratory confirmed with the predominately circulating influenza virus over eight seasons (2003-2011). Using the test-negative case-control design, we compared the vaccination status of swabbed influenza-like illnesses (ILI) patients who were laboratory confirmed with predominantly circulating influenza strain in the season (cases) to that of ILI patients testing negative for any influenza (controls). Data on age, sex, vaccination status and laboratory results were available for all seasons. We used logistic regression to calculate adjusted influenza VE for age, week of swabbing, Spanish region and season. We calculated the influenza VE by each season and pooling the seasons with the same predominant type/subtype. Overall influenza VE against infection with A(H3N2) subtype (four seasons) was 31 (95% confidence interval (CI):10; 48). For seasonal influenza A(H1N1) (two seasons), the effectiveness was 86% (95% CI: 65; 94). Against B infection (three seasons), influenza VE was 47% (95% CI: 27; 62). The Spanish influenza surveillance system allowed estimating influenza VE in the studied seasons for the predominant strain. Strengthening the influenza surveillance will result in more precise VE estimates for decision making. Copyright © 2014 Elsevier Ltd. All rights reserved.

  18. Reconstitution technique for surveillance programs

    SciTech Connect

    Brumovsky, M.; Novosad, P.

    1996-09-01

    Surveillance programs of reactor pressure vessel materials play very important role in reactor pressure vessel lifetime assessment. Unfortunately, most of them were designed and manufactured many years ago when knowledge about radiation damage as well of fracture mechanics was substantially nonadequate to present requirements. Reconstitution techniques are very effective methods for obtaining necessary data from irradiated and previously tested surveillance specimens. Electron beam welding technique was chosen for reconstitution of irradiated surveillance specimens from WWER-440 reactor pressure vessels. This method was chosen as an effective one as practically no machining is necessary after welding as specimen dimensions and forms are fully maintained. Paper describes the reconstitution method and results obtained from its validation--time dependent temperature in the vicinity of the specimen notch to prove that this method does not affect irradiation damage in reconstituted specimens. Paper also gives results from first tests of re-assessed surveillance program of WWER-440 RPV: comparison of transition temperature shifts from original Charpy V-notch specimens with transition temperature shifts from reconstituted precracked Charpy specimens.

  19. Asymmetric Information in Iranian’s Health Insurance Market: Testing of Adverse Selection and Moral Hazard

    PubMed Central

    Lotfi, Farhad; Gorji, Hassan Abolghasem; Mahdavi, Ghadir; Hadian, Mohammad

    2015-01-01

    Background: Asymmetric information is one of the most important issues in insurance market which occurred due to inherent characteristics of one of the agents involved in insurance contracts; hence its management requires designing appropriate policies. This phenomenon can lead to the failure of insurance market via its two consequences, namely, adverse selection and moral hazard. Objective: This study was aimed to evaluate the status of asymmetric information in Iran’s health insurance market with respect to the demand for outpatient services. Materials/sPatients and Methods: This research is a cross sectional study conducted on households living in Iran. The data of the research was extracted from the information on household’s budget survey collected by the Statistical Center of Iran in 2012. In this study, the Generalized Method of Moment model was used and the status of adverse selection and moral hazard was evaluated through calculating the latent health status of individuals in each insurance category. To analyze the data, Excel, Eviews and stata11 software were used. Results: The estimation of parameters of the utility function of the demand for outpatient services (visit, medicine, and Para-clinical services) showed that households were more risk averse in the use of outpatient care than other goods and services. After estimating the health status of households based on their health insurance categories, the results showed that rural-insured people had the best health status and people with supplementary insurance had the worst health status. In addition, the comparison of the conditional distribution of latent health status approved the phenomenon of adverse selection in all insurance groups, with the exception of rural insurance. Moreover, calculation of the elasticity of medical expenses to reimbursement rate confirmed the existence of moral hazard phenomenon. Conclusions: Due to the existence of the phenomena of adverse selection and moral hazard

  20. Asymmetric Information in Iranian's Health Insurance Market: Testing of Adverse Selection and Moral Hazard.

    PubMed

    Lotfi, Farhad; Abolghasem Gorji, Hassan; Mahdavi, Ghadir; Hadian, Mohammad

    2015-04-19

    Asymmetric information is one of the most important issues in insurance market which occurred due to inherent characteristics of one of the agents involved in insurance contracts; hence its management requires designing appropriate policies. This phenomenon can lead to the failure of insurance market via its two consequences, namely, adverse selection and moral hazard. This study was aimed to evaluate the status of asymmetric information in Iran's health insurance market with respect to the demand for outpatient services. This research is a cross sectional study conducted on households living in Iran. The data of the research was extracted from the information on household's budget survey collected by the Statistical Center of Iran in 2012. In this study, the Generalized Method of Moment model was used and the status of adverse selection and moral hazard was evaluated through calculating the latent health status of individuals in each insurance category. To analyze the data, Excel, Eviews and stata11 software were used. The estimation of parameters of the utility function of the demand for outpatient services (visit, medicine, and Para-clinical services) showed that households were more risk averse in the use of outpatient care than other goods and services. After estimating the health status of households based on their health insurance categories, the results showed that rural-insured people had the best health status and people with supplementary insurance had the worst health status. In addition, the comparison of the conditional distribution of latent health status approved the phenomenon of adverse selection in all insurance groups, with the exception of rural insurance. Moreover, calculation of the elasticity of medical expenses to reimbursement rate confirmed the existence of moral hazard phenomenon. Due to the existence of the phenomena of adverse selection and moral hazard in most of health insurances categories, policymakers need to adjust contracts so

  1. Assessing the value-adding impact of diagnostic-type tests on drug development and marketing.

    PubMed

    Blair, Edward D

    2008-01-01

    We explore the cash value of the companion diagnostics opportunity from the perspective of the pharmaceutical partner. Cashflow-based modeling is used to demonstrate the potential financial benefits of key relationships between the pharmaceutical and diagnostics industries. In four scenarios, the uplift in the net present value (NPV) of a proprietary medicine can exceed $US1.8 billion. By simple extrapolation, the uplifted NPV calculations allow realistic and plausible estimates of the companion diagnostic opportunity to be in the region of $US40 billion to $US90 billion. It is expected that such market valuation could drive a macroeconomic change that shifts healthcare practice from reactionary disease-treatment to proactive health maintenance.

  2. Modernization of existing VVER-1000 surveillance programs

    SciTech Connect

    Kochkin, V.; Erak, D.; Makhotin, D.

    2011-07-01

    According to generally accepted world practice, evaluation of the reactor pressure vessel (RPV) material behavior during operation is carried out using tests of surveillance specimens. The main objective of the surveillance program consists in insurance of safe RPV operation during the design lifetime and lifetime-extension period. At present, the approaches of pressure vessels residual life validation based on the test results of their surveillance specimens have been developed and introduced in Russia and are under consideration in other countries where vodo-vodyanoi energetichesky reactors- (VVER-) 1000 are in operation. In this case, it is necessary to ensure leading irradiation of surveillance specimens (as compared to the pressure vessel wall) and to provide uniformly irradiated specimen groups for mechanical testing. Standard surveillance program of VVER-1000 has several significant shortcomings and does not meet these requirements. Taking into account program of lifetime extension of VVER-1000 operating in Russia, it is necessary to carry out upgrading of the VVER-1000 surveillance program. This paper studies the conditions of a surveillance specimen's irradiation and upgrading of existing sets to provide monitoring and prognosis of RPV material properties for extension of the reactor's lifetime up to 60 years or more. (authors)

  3. A clinical assessment of a patch test kit marketed to U.K. hairdressers for detecting hair dye allergy.

    PubMed

    Orton, D I

    2007-11-01

    In 2004 a U.K.-based company developed and marketed a patch test kit (Colourstart); Trichocare, Ridgmont, Beds, U.K.) for use by hairdressers. It is intended to assess whether clients have a 'problem with hair dye' and promotes itself as the 'only practical solution to sensitivity testing'. However, a patient presented with a hair dye reaction that had not been detected while using this patch test system. To assess the Colourstart system in the next seven consecutive patients presenting with a history of adverse reactions to hair dyes. The Colourstart system was tested in parallel with commercially available hair dye patch test reagents, where applicable. Only three of seven patients allergic to p-phenylenediamine were detected using this system and one patient allergic to toluene-2,5-diamine sulphate was not detected using this system. The results raise concerns about the sensitivity of this kit for consumer protection, but also wider questions about the regulation, use and interpretation of 'home diagnostic patch test kits' in general.

  4. Safety, Efficacy, and Persistence of Long-Term Mirabegron Treatment for Overactive Bladder in the Daily Clinical Setting: Interim (1-Year) Report from a Japanese Post-Marketing Surveillance Study.

    PubMed

    Kato, Daisuke; Tabuchi, Hiromi; Uno, Satoshi

    2017-08-01

    To report interim 1-year results from a 3-year surveillance study evaluating safety, efficacy, and persistence of long-term mirabegron for overactive bladder (OAB). Patients starting treatment with mirabegron for urinary urgency, daytime frequency, and urgency incontinence associated with OAB were registered and followed up for 3 years. Data were collected on adverse drug reactions (ADR), changes in OAB symptoms, changes in Overactive Bladder Symptom Score (OABSS), and treatment discontinuations. Treatment persistence rates were calculated by Kaplan-Meier analysis. Eighty-one ADR were observed in 72/1139 patients (6.3%) through 1 year of mirabegron treatment, with the incidence highest during the first month. No significant change in residual urine volume was observed at any observation point up to 1 year of mirabegron treatment. Mirabegron was deemed "effective" in 883/1091 patients (80.9%) at 1 year/discontinuation. Total OABSS was decreased with statistical significance at 3 months, 6 months, and 1 year, or at discontinuation (P < 0.001 at each time point). Kaplan-Meier treatment persistence rates were 84.8% at 3 months, 77.6% at 6 months, and 66.0% at 1 year. Treatment persistence rates were similar for male and female patients but significantly higher for patients aged ≥65 years (67.3%; n = 908) compared with those aged <65 years (59.8%; n = 231; log-rank test: P = 0.032). Long-term OAB treatment with mirabegron was well-tolerated, with effectiveness maintained through 1 year. Mirabegron treatment persistence was higher than has been previously reported, and was greater in patients aged ≥65 years compared with those aged <65 years. © 2017 John Wiley & Sons Australia, Ltd.

  5. International Organization of Standardization (ISO) and Cambridge Filter Test (CFT) Smoking Regimen Data Comparisons in Tobacco Product Marketing Applications.

    PubMed

    Chae, Changyu; Walters, Matthew J; Holman, Matthew R

    2017-07-01

    We investigated the differences in TNCO (tar, nicotine, and carbon monoxide) smoke yields generated under the International Organization of Standardization (ISO) and Federal Trade Commission (FTC) Cambridge Filter Test (CFT) smoking regimens. Twenty-nine commercial cigarette products from the US marketplace were acquired in 2015 and tested by measuring the TNCO smoke yields generated under these 2 nonintense smoking regimens. Data obtained demonstrated a linear relationship between the TNCO yields produced under the 2 smoking regimens (R(2) > 0.99). TNCO yields produced by each product were higher under the CFT smoking regimen than the ISO smoking regimen. We found that tar, nicotine, and carbon monoxide yields were consistently 10% to 13% higher under the CFT smoking regimen than under the ISO smoking regimen. This strong correlation indicates that the 2 smoking regimens can be used to apply a correlation correction to CFT TNCO data and allow its comparison to ISO TNCO data in tobacco product marketing applications.

  6. Markets, Managerialism and Teachers' Work: The Invisible Hand of High Stakes Testing in England

    ERIC Educational Resources Information Center

    Stevenson, Howard; Wood, Phil

    2013-01-01

    High stakes testing has been long established in the English school system. In this article, we seek to demonstrate how testing has become pivotal to securing the neo-liberal restructuring of schools, that commenced during the Thatcher era, and is reaching a critical point at the current time. Central to this project has been the need to assert…

  7. Surveillance for West Nile virus in clinic-admitted raptors, Colorado.

    PubMed

    Nemeth, Nicole; Kratz, Gail; Edwards, Eric; Scherpelz, Judy; Bowen, Richard; Komar, Nicholas

    2007-02-01

    In 2005, 13.5% of clinic-admitted raptors in northern Colorado tested positive for West Nile virus (WNV). Clinic-admitted-raptor surveillance detected WNV activity nearly 14 weeks earlier than other surveillance systems. WNV surveillance using live raptor admissions to rehabilitation clinics may offer a novel surveillance method and should be considered along with other techniques already in use.

  8. Surveillance for West Nile Virus in Clinic-admitted Raptors, Colorado

    PubMed Central

    Kratz, Gail; Edwards, Eric; Scherpelz, Judy; Bowen, Richard; Komar, Nicholas

    2007-01-01

    In 2005, 13.5% of clinic-admitted raptors in northern Colorado tested positive for West Nile virus (WNV). Clinic-admitted–raptor surveillance detected WNV activity nearly 14 weeks earlier than other surveillance systems. WNV surveillance using live raptor admissions to rehabilitation clinics may offer a novel surveillance method and should be considered along with other techniques already in use. PMID:17479898

  9. Development of a web-based epidemiological surveillance system with health system response for improving maternal and newborn health: Field-testing in Thailand.

    PubMed

    Liabsuetrakul, Tippawan; Prappre, Tagoon; Pairot, Pakamas; Oumudee, Nurlisa; Islam, Monir

    2017-06-01

    Surveillance systems are yet to be integrated with health information systems for improving the health of pregnant mothers and their newborns, particularly in developing countries. This study aimed to develop a web-based epidemiological surveillance system for maternal and newborn health with integration of action-oriented responses and automatic data analysis with results presentations and to assess the system acceptance by nurses and doctors involved in various hospitals in southern Thailand. Freeware software and scripting languages were used. The system can be run on different platforms, and it is accessible via various electronic devices. Automatic data analysis with results presentations in the forms of graphs, tables and maps was part of the system. A multi-level security system was incorporated into the program. Most doctors and nurses involved in the study felt the system was easy to use and useful. This system can be integrated into country routine reporting system for monitoring maternal and newborn health and survival.

  10. Redefining syndromic surveillance.

    PubMed

    Katz, Rebecca; May, Larissa; Baker, Julia; Test, Elisa

    2011-12-01

    With growing concerns about international spread of disease and expanding use of early disease detection surveillance methods, the field of syndromic surveillance has received increased attention over the last decade. The purpose of this article is to clarify the various meanings that have been assigned to the term syndromic surveillance and to propose a refined categorization of the characteristics of these systems. Existing literature and conference proceedings were examined on syndromic surveillance from 1998 to 2010, focusing on low- and middle-income settings. Based on the 36 unique definitions of syndromic surveillance found in the literature, five commonly accepted principles of syndromic surveillance systems were identified, as well as two fundamental categories: specific and non-specific disease detection. Ultimately, the proposed categorization of syndromic surveillance distinguishes between systems that focus on detecting defined syndromes or outcomes of interest and those that aim to uncover non-specific trends that suggest an outbreak may be occurring. By providing an accurate and comprehensive picture of this field's capabilities, and differentiating among system types, a unified understanding of the syndromic surveillance field can be developed, encouraging the adoption, investment in, and implementation of these systems in settings that need bolstered surveillance capacity, particularly low- and middle-income countries. Copyright © 2011 Ministry of Health, Saudi Arabia. Published by Elsevier Ltd. All rights reserved.

  11. Surveillance as cultural practice.

    PubMed

    Monahan, Torin

    2011-01-01

    This special section of The Sociological Quarterly explores research on “surveillance as cultural practice,” which indicates an orientation to surveillance that views it as embedded within, brought about by, and generative of social practices in specific cultural contexts. Such an approach is more likely to include elements of popular culture, media, art, and narrative; it is also more likely to try to comprehend people's engagement with surveillance on their own terms, stressing the production of emic over etic forms of knowledge. This introduction sketches some key developments in this area and discusses their implications for the field of “surveillance studies” as a whole.

  12. Audits and surveillance: A functional quality surveillance system

    SciTech Connect

    Smart, R.J.; Duda, J.E.

    1987-03-01

    The implementation of a quality surveillance program can be painless and productive. The system described in this report has been in use at the Fast Flux Test Facility (FFTF) for more than a year and effectively fills the void between audits and inspections. Recognized benefits of this system include: minimum administrative overhead; excellent management overview; ease of implementing trending efforts; audit supplement; fully computerization; lower cost than traditional methods; early problem detection, adaptability to other projects and facilities.

  13. The New Product Watch: Successes and Challenges of Crowdsourcing as a Method of Surveillance.

    PubMed

    Nyman, Amy L; Biener, Lois

    2016-01-01

    New smokeless tobacco (eg, snus and dissolvable tobacco products) and nontobacco nicotine products (eg, e-cigarettes) have emerged in recent years amid widespread speculation about locations of test marketing, toxic constituents, and consumer targeting. The New Product Watch was a pilot online monitoring system aimed at filling these information gaps by using a form of crowdsourcing: recruiting volunteers to visit local retailers and report their findings. With very little funding, the New Product Watch gathered county-specific data on new product availability in 19 states as well as trend data on product marketing and demand, and completed 2 rounds of product purchases and subsequent toxic constituent analyses. Data were collected over a 2-year period, between 2009 and 2011. Despite the successes, we found that this small-scale, volunteer effort was not a sustainable method for ensuring continuous, systematic surveillance of new product availability, marketing, and toxicity.

  14. The surveillance error grid.

    PubMed

    Klonoff, David C; Lias, Courtney; Vigersky, Robert; Clarke, William; Parkes, Joan Lee; Sacks, David B; Kirkman, M Sue; Kovatchev, Boris

    2014-07-01

    Currently used error grids for assessing clinical accuracy of blood glucose monitors are based on out-of-date medical practices. Error grids have not been widely embraced by regulatory agencies for clearance of monitors, but this type of tool could be useful for surveillance of the performance of cleared products. Diabetes Technology Society together with representatives from the Food and Drug Administration, the American Diabetes Association, the Endocrine Society, and the Association for the Advancement of Medical Instrumentation, and representatives of academia, industry, and government, have developed a new error grid, called the surveillance error grid (SEG) as a tool to assess the degree of clinical risk from inaccurate blood glucose (BG) monitors. A total of 206 diabetes clinicians were surveyed about the clinical risk of errors of measured BG levels by a monitor. The impact of such errors on 4 patient scenarios was surveyed. Each monitor/reference data pair was scored and color-coded on a graph per its average risk rating. Using modeled data representative of the accuracy of contemporary meters, the relationships between clinical risk and monitor error were calculated for the Clarke error grid (CEG), Parkes error grid (PEG), and SEG. SEG action boundaries were consistent across scenarios, regardless of whether the patient was type 1 or type 2 or using insulin or not. No significant differences were noted between responses of adult/pediatric or 4 types of clinicians. Although small specific differences in risk boundaries between US and non-US clinicians were noted, the panel felt they did not justify separate grids for these 2 types of clinicians. The data points of the SEG were classified in 15 zones according to their assigned level of risk, which allowed for comparisons with the classic CEG and PEG. Modeled glucose monitor data with realistic self-monitoring of blood glucose errors derived from meter testing experiments plotted on the SEG when compared to

  15. Marketing the HIV Test to MSM: Ethnic Differences in Preferred Venues and Sources

    PubMed Central

    Lechuga, Julia; Owczarzak, Jill T.; Petroll, Andrew E.

    2014-01-01

    Lack of awareness of HIV status is associated with an increased likelihood of HIV transmission. We surveyed 633 men who have sex with men (MSM) from diverse ethnic groups recruited from a variety of community venues in a U.S. Midwestern city with rising HIV infection rates. Our first aim was to describe patterns of sexual risk, annual HIV testing frequency, and venues where information about HIV and HIV testing could be disseminated to inner-city MSM. Our second aim was to identify preferred sources to receive information about HIV testing and determine whether these preferences differed by ethnic background. Results indicated that despite similar proportions of high–sexual risk behaviors, compared with African American and Latino MSM, smaller proportions of non-Hispanic White MSM had received an HIV test in the last 12 months. Despite ethnic differences in health care access, a physician's office was the most common HIV testing site. Overall, a majority conveyed a preference to see advertisements in mainstream media outlets. However, when preferences were stratified by ethnicity, African American MSM were the least likely to prefer receiving information from mainstream media and conveyed a stronger preference to receive information from authority figures than non-Hispanic White and Hispanic MSM. PMID:23091299

  16. Acute Diarrheal Syndromic Surveillance

    PubMed Central

    Kam, H.J.; Choi, S.; Cho, J.P.; Min, Y.G.; Park, R.W.

    2010-01-01

    Objective In an effort to identify and characterize the environmental factors that affect the number of patients with acute diarrheal (AD) syndrome, we developed and tested two regional surveillance models including holiday and weather information in addition to visitor records, at emergency medical facilities in the Seoul metropolitan area of Korea. Methods With 1,328,686 emergency department visitor records from the National Emergency Department Information system (NEDIS) and the holiday and weather information, two seasonal ARIMA models were constructed: (1) The simple model (only with total patient number), (2) the environmental factor-added model. The stationary R-squared was utilized as an in-sample model goodness-of-fit statistic for the constructed models, and the cumulative mean of the Mean Absolute Percentage Error (MAPE) was used to measure post-sample forecast accuracy over the next 1 month. Results The (1,0,1)(0,1,1)7 ARIMA model resulted in an adequate model fit for the daily number of AD patient visits over 12 months for both cases. Among various features, the total number of patient visits was selected as a commonly influential independent variable. Additionally, for the environmental factor-added model, holidays and daily precipitation were selected as features that statistically significantly affected model fitting. Stationary R-squared values were changed in a range of 0.651-0.828 (simple), and 0.805-0.844 (environmental factor-added) with p<0.05. In terms of prediction, the MAPE values changed within 0.090-0.120 and 0.089-0.114, respectively. Conclusion The environmental factor-added model yielded better MAPE values. Holiday and weather information appear to be crucial for the construction of an accurate syndromic surveillance model for AD, in addition to the visitor and assessment records. PMID:23616829