[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.

Logistic Regression Likelihood Ratio Test Analysis for Detecting Signals of Adverse Events in Post-market Safety Surveillance.

PubMed

Nam, Kijoeng; Henderson, Nicholas C; Rohan, Patricia; Woo, Emily Jane; Russek-Cohen, Estelle

2017-01-01

The Vaccine Adverse Event Reporting System (VAERS) and other product surveillance systems compile reports of product-associated adverse events (AEs), and these reports may include a wide range of information including age, gender, and concomitant vaccines. Controlling for possible confounding variables such as these is an important task when utilizing surveillance systems to monitor post-market product safety. A common method for handling possible confounders is to compare observed product-AE combinations with adjusted baseline frequencies where the adjustments are made by stratifying on observable characteristics. Though approaches such as these have proven to be useful, in this article we propose a more flexible logistic regression approach which allows for covariates of all types rather than relying solely on stratification. Indeed, a main advantage of our approach is that the general regression framework provides flexibility to incorporate additional information such as demographic factors and concomitant vaccines. As part of our covariate-adjusted method, we outline a procedure for signal detection that accounts for multiple comparisons and controls the overall Type 1 error rate. To demonstrate the effectiveness of our approach, we illustrate our method with an example involving febrile convulsion, and we further evaluate its performance in a series of simulation studies.

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.

Development of the Diabetes Technology Society Blood Glucose Monitor System Surveillance Protocol

PubMed Central

Klonoff, David C.; Lias, Courtney; Beck, Stayce; Parkes, Joan Lee; Kovatchev, Boris; Vigersky, Robert A.; Arreaza-Rubin, Guillermo; Burk, Robert D.; Kowalski, Aaron; Little, Randie; Nichols, James; Petersen, Matt; Rawlings, Kelly; Sacks, David B.; Sampson, Eric; Scott, Steve; Seley, Jane Jeffrie; Slingerland, Robbert; Vesper, Hubert W.

2015-01-01

Background: Inaccurate blood glucsoe monitoring systems (BGMSs) can lead to adverse health effects. The Diabetes Technology Society (DTS) Surveillance Program for cleared BGMSs is intended to protect people with diabetes from inaccurate, unreliable BGMS products that are currently on the market in the United States. The Surveillance Program will provide an independent assessment of the analytical performance of cleared BGMSs. Methods: The DTS BGMS Surveillance Program Steering Committee included experts in glucose monitoring, surveillance testing, and regulatory science. Over one year, the committee engaged in meetings and teleconferences aiming to describe how to conduct BGMS surveillance studies in a scientifically sound manner that is in compliance with good clinical practice and all relevant regulations. Results: A clinical surveillance protocol was created that contains performance targets and analytical accuracy-testing studies with marketed BGMS products conducted by qualified clinical and laboratory sites. This protocol entitled “Protocol for the Diabetes Technology Society Blood Glucose Monitor System Surveillance Program” is attached as supplementary material. Conclusion: This program is needed because currently once a BGMS product has been cleared for use by the FDA, no systematic postmarket Surveillance Program exists that can monitor analytical performance and detect potential problems. This protocol will allow identification of inaccurate and unreliable BGMSs currently available on the US market. The DTS Surveillance Program will provide BGMS manufacturers a benchmark to understand the postmarket analytical performance of their products. Furthermore, patients, health care professionals, payers, and regulatory agencies will be able to use the results of the study to make informed decisions to, respectively, select, prescribe, finance, and regulate BGMSs on the market. PMID:26481642

Development of the Diabetes Technology Society Blood Glucose Monitor System Surveillance Protocol.

PubMed

Klonoff, David C; Lias, Courtney; Beck, Stayce; Parkes, Joan Lee; Kovatchev, Boris; Vigersky, Robert A; Arreaza-Rubin, Guillermo; Burk, Robert D; Kowalski, Aaron; Little, Randie; Nichols, James; Petersen, Matt; Rawlings, Kelly; Sacks, David B; Sampson, Eric; Scott, Steve; Seley, Jane Jeffrie; Slingerland, Robbert; Vesper, Hubert W

2016-05-01

Inaccurate blood glucsoe monitoring systems (BGMSs) can lead to adverse health effects. The Diabetes Technology Society (DTS) Surveillance Program for cleared BGMSs is intended to protect people with diabetes from inaccurate, unreliable BGMS products that are currently on the market in the United States. The Surveillance Program will provide an independent assessment of the analytical performance of cleared BGMSs. The DTS BGMS Surveillance Program Steering Committee included experts in glucose monitoring, surveillance testing, and regulatory science. Over one year, the committee engaged in meetings and teleconferences aiming to describe how to conduct BGMS surveillance studies in a scientifically sound manner that is in compliance with good clinical practice and all relevant regulations. A clinical surveillance protocol was created that contains performance targets and analytical accuracy-testing studies with marketed BGMS products conducted by qualified clinical and laboratory sites. This protocol entitled "Protocol for the Diabetes Technology Society Blood Glucose Monitor System Surveillance Program" is attached as supplementary material. This program is needed because currently once a BGMS product has been cleared for use by the FDA, no systematic postmarket Surveillance Program exists that can monitor analytical performance and detect potential problems. This protocol will allow identification of inaccurate and unreliable BGMSs currently available on the US market. The DTS Surveillance Program will provide BGMS manufacturers a benchmark to understand the postmarket analytical performance of their products. Furthermore, patients, health care professionals, payers, and regulatory agencies will be able to use the results of the study to make informed decisions to, respectively, select, prescribe, finance, and regulate BGMSs on the market. © 2015 Diabetes Technology Society.

The applicability of animal health surveillance systems for post-market monitoring of potential adverse effects of genetically modified (GM) feed.

PubMed

Vince, L; Kleter, G A; Kostov, K; Pfeiffer, D U; Guitian, J

2018-04-20

A facultative post market monitoring of potential health impacts of genetically modified (GM) feedstuffs on livestock consuming these feeds after pre-market risk assessment is under ongoing consideration. Within the IPAFEED database, scientific studies on health effects beyond performance in livestock and the results of a systematic search for evidence of outcome effects due to GM feed are consolidated. These outcomes were reviewed and checked for consistency in order to identify plausible syndromes suitable for conducting surveillance. The 24 selected studies showed no consistent changes in any health parameter. There were no repeated studies in any species by GM crop type and animal species. As such, there is insufficient evidence to inform the design of surveillance systems for detecting known adverse effects. Animal health surveillance systems have been proposed for the post market monitoring of potential adverse effects in animals. Such systems were evaluated for their applicability to the detection of hypothetical adverse effects and their strengths and weaknesses to detect syndromes of concern are presented. For known adverse effects, applied controlled post-market studies may yield conclusive and high-quality evidence. For detecting unknown adverse effects, the use of existing surveillance systems may still be of interest. A simulation tool developed within the project can be adapted and applied to existing surveillance systems to explore their applicability to the detection of potential adverse effects of GM feed. Copyright © 2018. Published by Elsevier Ltd.

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.

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.

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

Worldwide, 3-Year, Post-Marketing Surveillance Experience with Tofacitinib in Rheumatoid Arthritis.

PubMed

Cohen, Stanley; Curtis, Jeffrey R; DeMasi, Ryan; Chen, Yan; Fan, Haiyun; Soonasra, Arif; Fleischmann, Roy

2018-06-01

Post-marketing surveillance (PMS) is an integral part of monitoring adverse events (AEs) following approval of new drugs. Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). An analysis of PMS reports was conducted to evaluate the safety of tofacitinib in a post-marketing setting. Worldwide tofacitinib PMS data received in the Pfizer safety database from November 6, 2012 (first marketing authorization of tofacitinib) to November 5, 2015 were analyzed. Serious AEs (SAEs) of interest were reviewed and reporting rates (RRs) were calculated by dividing the number of SAEs by the estimated 100 patient-years of exposure. Patient exposure was calculated based on estimated worldwide sales and an estimated daily regimen of tofacitinib 5 mg twice daily. During the 3-year reporting period, worldwide post-marketing exposure to tofacitinib since approval was estimated to be 34,223 patient-years. In total, 9291 case reports (82.9% non-serious) were received and 25,417 AEs, 102 fatal cases, and 4352 SAEs were reported. The RRs (per 100 patient-years) for SAEs of interest by Medical Dictionary for Regulatory Activities System Organ Class were 2.57 for infections, 0.91 for gastrointestinal disorders, 0.60 for respiratory disorders, 0.45 for neoplasms, 0.43 for cardiac disorders, and 0.12 for hepatobiliary disorders. Although there are limitations to these data, no new safety risks were revealed in this real-world setting compared with the safety profile identified in the tofacitinib RA clinical development program. Any risks identified through the tofacitinib development program and PMS will continue to be monitored through pharmacovigilance surveillance. Pfizer Inc.

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.

Results of European post-marketing surveillance of bosentan in pulmonary hypertension.

PubMed

Humbert, M; Segal, E S; Kiely, D G; Carlsen, J; Schwierin, B; Hoeper, M M

2007-08-01

After the approval of bosentan for the treatment of pulmonary arterial hypertension (PAH), European authorities required the introduction of a post-marketing surveillance system (PMS) to obtain further data on its safety profile. A novel, prospective, internet-based PMS was designed, which solicited reports on elevated aminotransferases, medical reasons for bosentan discontinuation and other serious adverse events requiring hospitalisation. Data captured included demographics, PAH aetiology, baseline functional status and concomitant PAH-specific medications. Safety signals captured included death, hospitalisation, serious adverse events, unexpected adverse events and elevated aminotransferases. Within 30 months, 4,994 patients were included, representing 79% of patients receiving bosentan in Europe. In total, 4,623 patients were naïve to treatment; of these, 352 had elevated aminotransferases, corresponding to a crude incidence of 7.6% and an annual rate of 10.1%. Bosentan was discontinued due to elevated aminotransferases in 150 (3.2%) bosentan-naïve patients. Safety results were consistent across subgroups and aetiologies. The novel post-marketing surveillance captured targeted safety data ("potential safety signals") from the majority of patients and confirmed that the incidence and severity of elevated aminotransferase levels in clinical practice was similar to that reported in clinical trials. These data complement those from randomised controlled clinical trials and provide important additional information on the safety profile of bosentan.

Use of prostate-specific antigen testing as a disease surveillance tool following radical prostatectomy

PubMed Central

Trantham, Laurel Clayton; Nielsen, Matthew E.; Mobley, Lee R.; Wheeler, Stephanie B.; Carpenter, William R.; Biddle, Andrea K.

2013-01-01

Background Prostate-specific antigen (PSA) testing is recommended every 6 to 12 months for the first 5 years following radical prostatectomy as a means to detect potential disease recurrence. Despite substantial research on factors affecting treatment decisions, recurrence, and mortality, little is known about whether men receive guideline-concordant surveillance testing or whether receipt varies by year of diagnosis, time since treatment, or other individual characteristics. Methods Surveillance testing following radical prostatectomy among elderly men was examined using Surveillance, Epidemiology, and End Results cancer registry data linked to Medicare claims. Multivariate logistic regression was used to examine the effect of demographic, tumor, and county-level characteristics on the odds of receiving surveillance testing within a given one-year period following treatment. Results Overall, receipt of surveillance testing was high, with 96% of men receiving at least one test the first year after treatment and approximately 80% receiving at least one test in the fifth year after treatment. Odds of not receiving a test declined with time since treatment. Non-married men, men with less advanced disease, and non-Hispanic Blacks and Hispanics had higher odds of not receiving a surveillance test. Year of diagnosis did not affect the receipt of surveillance tests. Conclusion Most men receive guideline-concordant surveillance PSA testing after prostatectomy, although evidence of a racial disparity between non-Hispanic Whites and some minority groups exists. The decline in surveillance over time suggests the need for well-designed long-term surveillance plans following radical prostatectomy. PMID:23893821

Use of prostate-specific antigen testing as a disease surveillance tool following radical prostatectomy.

PubMed

Trantham, Laurel Clayton; Nielsen, Matthew E; Mobley, Lee R; Wheeler, Stephanie B; Carpenter, William R; Biddle, Andrea K

2013-10-01

Prostate-specific antigen (PSA) testing is recommended every 6 to 12 months for the first 5 years following radical prostatectomy as a means to detect potential disease recurrence. Despite substantial research on factors affecting treatment decisions, recurrence, and mortality, little is known about whether men receive guideline-concordant surveillance testing or whether receipt varies by year of diagnosis, time since treatment, or other individual characteristics. Surveillance testing following radical prostatectomy among elderly men was examined using Surveillance, Epidemiology, and End Results cancer registry data linked to Medicare claims. Multivariate logistic regression was used to examine the effect of demographic, tumor, and county-level characteristics on the odds of receiving surveillance testing within a given 1-year period following treatment. Overall, receipt of surveillance testing was high, with 96% of men receiving at least one test the first year after treatment and approximately 80% receiving at least one test in the fifth year after treatment. Odds of not receiving a test declined with time since treatment. Nonmarried men, men with less-advanced disease, and non-Hispanic blacks and Hispanics had higher odds of not receiving a surveillance test. Year of diagnosis did not affect the receipt of surveillance tests. Most men receive guideline-concordant surveillance PSA testing after prostatectomy, although evidence of a racial disparity between non-Hispanic whites and some minority groups exists. The decline in surveillance over time suggests the need for well-designed long-term surveillance plans following radical prostatectomy. Cancer 2013;119:3523-3530.. © 2013 American Cancer Society. Copyright © 2013 American Cancer Society.

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.

Texas Adolescent Tobacco and Marketing Surveillance System’s Design

PubMed Central

Pérez, Adriana; Harrell, Melissa B.; Malkani, Raja I.; Jackson, Christian D.; Delk, Joanne; Allotey, Prince A.; Matthews, Krystin J.; Martinez, Pablo; Perry, Cheryl L.

2017-01-01

Objectives To provide a full methodological description of the design of the wave I and II (6-month follow-up) surveys of the Texas Adolescent Tobacco and Marketing Surveillance System (TATAMS), a longitudinal surveillance study of 6th, 8th, and 10th grade students who attended schools in Bexar, Dallas, Tarrant, Harris, or Travis counties, where the 4 largest cities in Texas (San Antonio, Dallas, Fort Worth, Houston, and Austin, respectively) are located. Methods TATAMS used a complex probability design, yielding representative estimates of these students in these counties during the 2014–2015 academic year. Weighted prevalence of the use of tobacco products, drugs and alcohol in wave I, and the percent of: (i) bias, (ii) relative bias, and (iii) relative bias ratio, between waves I and II are estimated. Results The wave I sample included 79 schools and 3,907 students. The prevalence of current cigarette, e-cigarette and hookah use at wave I was 3.5%, 7.4%, and 2.5%, respectively. Small biases, mostly less than 3.5%, were observed for nonrespondents in wave II. Conclusions Even with adaptions to the sampling methodology, the resulting sample adequately represents the target population. Results from TATAMS will have important implications for future tobacco policy in Texas and federal regulation. PMID:29098172

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.

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

PubMed

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

2013-01-01

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

17 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 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...

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...

2003 Nevada Test Site Annual Illness and Injury Surveillance Report

DOE Office of Scientific and Technical Information (OSTI.GOV)

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.

76 FR 3679 - Market Test of Marketing Mail Made Easy

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-20

... POSTAL REGULATORY COMMISSION [Docket No. MT2011-3; Order No. 649] Market Test of Marketing Mail... recently-filed Postal Service proposal to conduct a 2-year market test involving the sale of Marketing Mail Made Easy. This document describes the proposed test, addresses procedural aspects of the filing, and...

75 FR 17174 - Market Test

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-05

... POSTAL REGULATORY COMMISSION [Docket No. MT2010-1; Order No. 434] Market Test AGENCY: Postal... notice announcing its intent to initiate a market test. This notice addresses procedural steps associated... intent to initiate a market test beginning on or about May 1, 2010, of an experimental competitive...

Pharmacodynamic analysis of eribulin safety in breast cancer patients using real-world post-marketing surveillance data.

PubMed

Kawamura, Takahisa; Kasai, Hidefumi; Fermanelli, Valentina; Takahashi, Toshiaki; Sakata, Yukinori; Matsuoka, Toshiyuki; Ishii, Mika; Tanigawara, Yusuke

2018-06-22

Post-marketing surveillance is useful to collect safety data in real-world clinical settings. In this study, we firstly applied the post-marketing real-world data on a mechanistic model analysis for neutropenic profiles of eribulin in patients with recurrent or metastatic breast cancer (RBC/MBC). Demographic and safety data were collected using an active surveillance method from eribulin-treated RBC/MBC patients. Changes in neutrophil counts over time were analyzed using a mechanistic pharmacodynamic model. Pathophysiological factors that may affect the severity of neutropenia were investigated and neutropenic patterns were simulated for different treatment schedules. Clinical and laboratory data were collected from 401 patients (5199 neutrophil count measurements) who had not received granulocyte colony stimulating factor and were eligible for pharmacodynamic analysis. The estimated mean parameters were: mean transit time = 104.5 h, neutrophil proliferation rate constant = 0.0377 h -1 , neutrophil elimination rate constant = 0.0295 h -1 , and linear coefficient of drug effect = 0.0413 mL/ng. Low serum albumin levels and low baseline neutrophil counts were associated with severe neutropenia. The probability of grade ≥3 neutropenia was predicted to be 69%, 27%, and 27% for patients on standard, biweekly, and triweekly treatment scenarios, respectively, based on virtual simulations using the developed pharmacodynamic model. In conclusion, this is the first application of post-marketing surveillance data to a model-based safety analysis. This analysis of safety data reflecting authentic clinical settings will provide useful information on the safe use and potential risk factors of eribulin. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Avian influenza surveillance in domestic waterfowl and environment of live bird markets in Bangladesh, 2007-2012.

PubMed

Khan, Salah Uddin; Gurley, Emily S; Gerloff, Nancy; Rahman, Md Z; Simpson, Natosha; Rahman, Mustafizur; Haider, Najmul; Chowdhury, Sukanta; Balish, Amanda; Zaman, Rashid Uz; Nasreen, Sharifa; Chandra Das, Bidhan; Azziz-Baumgartner, Eduardo; Sturm-Ramirez, Katharine; Davis, C Todd; Donis, Ruben O; Luby, Stephen P

2018-06-20

Avian influenza viruses, including highly pathogenic strains, pose severe economic, animal and public health concerns. We implemented live bird market surveillance in Bangladesh to identify the subtypes of avian influenza A viruses in domestic waterfowl and market environments. We collected waterfowl samples monthly from 4 rural sites from 2007 to 2012 and environmental samples from 4 rural and 16 urban sites from 2009 to 2012. Samples were tested through real-time RT-PCR, virus culture, and sequencing to detect and characterize avian influenza A viruses. Among 4,308 waterfowl tested, 191 (4.4%) were positive for avian influenza A virus, including 74 (1.9%) avian influenza A/H5 subtype. The majority (99%, n = 73) of the influenza A/H5-positive samples were from healthy appearing waterfowl. Multiple subtypes, including H1N1, H1N3, H3N2, H3N6, H3N8, H4N1, H4N2, H4N6, H5N1 (clades 2.2.2, 2.3.2.1a, 2.3.4.2), H5N2, H6N1, H7N9, H9N2, H11N2 and H11N3, H11N6 were detected in waterfowl and environmental samples. Environmental samples tested positive for influenza A viruses throughout the year. Avian influenza viruses, including H5N1 and H9N2 subtypes were also identified in backyard and small-scale raised poultry. Live bird markets could be high-risk sites for harboring the viruses and have the potential to infect naive birds and humans exposed to them.

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.

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.

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.

[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.

Post-marketing surveillance of sertindole.

PubMed

Toumi, Mondher

2002-01-01

The atypical antipsychotic drug, sertindole, like several other drugs, causes QT interval prolongation. Prolongation of the QT interval on the electrocardiogram has been associated with an increased risk of ventricular arrhythmia, including the more serious form, torsades de pointes, and is thus a safety concern for the authorities. In the case of sertindole, however, the available pharmacoepidemiological studies gathering data from about 10 000 patients documented the lack of increased risk associated to sertindole in comparison to other atypical antipsychotics. On the basis of these data, as well as non-clinical and clinical safety data, the CPMP expert group concluded that, although sertindole has the potential to prolong the QT interval, ¤ ¤ QT interval prolongation does not seem to be a reliable proxy for the risk of severe cardiac arrhythmias'', and there are no clinical data suggesting that sertindole is more arrhythmogenic than are other atypical antipsychotics. To further substantiate this conclusion, two post-marketing surveillance studies have been initiated. One is a randomized comparison of sertindole and risperidone under normal conditions of use. Randomization minimizes selection bias and the intention is that allocation to the two treatment arms will yield comparable treatment groups. While the two drugs will be given in an open-label fashion, all safety data will be blinded and reviewed by an independent safety committee. The other study is an observational study that includes all patients prescribed sertindole who, for whatever reason, will not be included in the randomized study. In all, 10 000 patients are expected to take part in the studies, which will run for at least 1 year.

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)

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.

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

2018-01-01

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.

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.

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.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-20

... POSTAL SERVICE Market Test of Experimental Product: ``Marketing Mail Made Easy'' AGENCY: Postal Service TM . ACTION: Notice. SUMMARY: The Postal Service gives notice of a market test of an experimental...[supreg] hereby gives notice pursuant to 39 U.S.C. 3641(c)(1) that it will begin a market test of its...

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.

Screening test recommendations for methicillin-resistant Staphylococcus aureus surveillance practices: A cost-minimization analysis.

PubMed

Whittington, Melanie D; Curtis, Donna J; Atherly, Adam J; Bradley, Cathy J; Lindrooth, Richard C; Campbell, Jonathan D

2017-07-01

To mitigate methicillin-resistant Staphylococcus aureus (MRSA) infections, intensive care units (ICUs) conduct surveillance through screening patients upon admission followed by adhering to isolation precautions. Two surveillance approaches commonly implemented are universal preemptive isolation and targeted isolation of only MRSA-positive patients. Decision analysis was used to calculate the total cost of universal preemptive isolation and targeted isolation. The screening test used as part of the surveillance practice was varied to identify which screening test minimized inappropriate and total costs. A probabilistic sensitivity analysis was conducted to evaluate the range of total costs resulting from variation in inputs. The total cost of the universal preemptive isolation surveillance practice was minimized when a polymerase chain reaction screening test was used ($82.51 per patient). Costs were $207.60 more per patient when a conventional culture was used due to the longer turnaround time and thus higher isolation costs. The total cost of the targeted isolation surveillance practice was minimized when chromogenic agar 24-hour testing was used ($8.54 per patient). Costs were $22.41 more per patient when polymerase chain reaction was used. For ICUs that preemptively isolate all patients, the use of a polymerase chain reaction screening test is recommended because it can minimize total costs by reducing inappropriate isolation costs. For ICUs that only isolate MRSA-positive patients, the use of chromogenic agar 24-hour testing is recommended to minimize total costs. Copyright © 2017 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

76 FR 74078 - Standard Mail Market Test

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-30

... POSTAL REGULATORY COMMISSION [Docket No. MT2011-3; Order No. 998] Standard Mail Market Test AGENCY... Service application for an exemption from the annual revenue limitation that applies to market tests of... limitation in any year during the test of an experimental market dominant product.\\1\\ Pursuant to 39 U.S.C...

78 FR 39020 - Market Test on Gift Cards

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-28

... POSTAL REGULATORY COMMISSION [Docket No. MT2011-2; Order No. 1755] Market Test on Gift Cards... Service filing requesting a temporary extension of a market test on gift cards. This notice informs the... market test under 39 U.S.C. 3641(d).\\1\\ The market test is set to expire June 27, 2013. Motion at 1. The...

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

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...

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...

[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

Market surveillance of in vitro diagnostics by the BfArM until end 2010: how safe are products for tumor diagnostics?

PubMed

Siekmeier, R; Wetzel, D

2013-01-01

The European Directive 98/79/EC on in vitro diagnostic medical devices (IVD) regulates the marketing and post market surveillance of IVD in the European Economic Area. In cases of incidents and field corrective actions the manufacturers have to inform the responsible Competent Authorities (CA). In Germany, the Federal Institute for Drugs and Medical Devices (BfArM) is the responsible CA for most IVD. In this study all notifications regarding IVD (tests, calibrators, kits, and control materials, except laboratory analyzers) for tumor diagnostics received by the BfArM between begin 1999 until end of 2010 were analyzed. All notifications were analyzed in respect to the type of product, the source of notification, the underlying product defects and the corrective actions performed. In the observation period, a total of 2,851 notifications were received of which 84 were related to IVD for tumor diagnostics included in this study (clinical chemistry - 63, histology - 6, molecular biology - 3, rapid tests - 12). Reports were received from manufacturers (68 cases), CA (8 cases), users (4 cases) and other sources (4 cases). In the group of IVD based on clinical chemistry means, the affected products were mostly those for the measurement of prostate specific antigen (PSA, 14 cases), human chorion gonadotropine (13 cases), carcino embryonic antigen (6 cases), CA 19-9 (6 cases), α(1)-fetoprotein (6 cases) and CA 125 (5 cases), whereas in test strips 9 out of the 12 notifications were related to PSA. Investigations of the manufacturers were able to identify the underlying root causes of product failures in 66 cases (78.6%). In 10 cases (11.9%) the root cause remained unclear and in 6 cases and 2 cases (7.1% and 2.4%) a product failure was excluded or a user error was the underlying cause. Most common root causes of product failures were material defects (24 cases) and manufacturing errors (15 cases). Corrective actions were performed by the manufacturers in 64 cases (76

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.

Screening and surveillance. OSHA's medical surveillance provisions.

PubMed

Papp, E M; Miller, A S

2000-02-01

The OSH Act requires OSHA to include provisions for medical examinations of employees in its standards. However, the specific test and examinations criteria are not outlined in the OSH Act. Instead, each standard has specific medical surveillance requirements. These are specific to the adverse health effects triggered by exposure to the hazardous substance. The OSHA uses the term medical surveillance to refer to its employee examination and testing provisions. Most occupational health professionals call this activity employee screening and reserve the term surveillance for aggregate analysis of population data. It is important to remember this distinction when referring to OSHA standards. Many standards are challenged in court resulting in changes to medical surveillance provisions of the standards. Some court decisions support OSHA's language. In either case, the court often sets precedents for future standards.

The development and pilot testing of the marijuana retail surveillance tool (MRST): assessing marketing and point-of-sale practices among recreational marijuana retailers.

PubMed

Berg, Carla J; Henriksen, Lisa; Cavazos-Rehg, Patricia; Schauer, Gillian L; Freisthler, Bridget

2017-12-01

As recreational marijuana expands, it is critical to develop standardized surveillance measures to study the retail environment. To this end, our research team developed and piloted a tool assessing recreational marijuana retailers in a convenience sample of 20 Denver retailers in 2016. The tool assesses: (i) compliance and security (e.g. age-of-sale signage, ID checks, security cameras); (ii) marketing (i.e. promotions, product availability and price) and (iii) contextual and neighborhood features (i.e. retailer type, facilities nearby). Most shops (90.0%) indicated the minimum age requirement, all verified age. All shops posted interior ads (M = 2.6/retailer, SD = 3.4), primarily to promote edibles and other non-smoked products. Price promotions were common in shops (73.7%), 57.9% used social media promotions and 31.6% had take-away materials (e.g. menus, party promotions). Nearly half of the shops (42.1%) advertised health claims. All shops offered bud, joints, honey oil, tinctures, kief, beverages, edibles and topicals; fewer sold clones and seeds. Six shops (31.6%) sold shop-branded apparel and/or paraphernalia. Prices for bud varied within and between stores ($20-$45/'eighth', ∼3.5 g). Twelve were recreational only, and eight were both recreational and medicinal. Liquor stores were commonly proximal. Reliability assessments with larger, representative samples are needed to create a standardized marijuana retail surveillance tool. © The Author 2017. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.

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.

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...

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 marketing...

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 marketing...

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 marketing...

Testing a symptom-based surveillance system at high-profile gatherings as a preparatory measure for bioterrorism.

PubMed

Osaka, K; Takahashi, H; Ohyama, T

2002-12-01

We tested symptom-based surveillance during the G8 conference in 2000 as a means of detecting outbreaks, including bio-terrorism attacks, promptly. Five categories of symptoms (skin and haemorrhagic, respiratory, gastrointestinal, neurological and unexplained) were adopted for the case definition of the surveillance. The surveillance began I week before the conference, and continued until 1 week after the conference ended. We could not detect any outbreaks during this surveillance. Compared to the existing diagnosis-based surveillance system, symptom-based surveillance has the advantages of timeliness and simplicity. However, poor specificity and difficulties in determining epidemic threshold were important limitations of this system. To increase the specificity of surveillance, it is essential to incorporate rapid laboratory diagnoses into the system.

76 FR 22739 - Postal Service Market Test

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-22

... POSTAL REGULATORY COMMISSION [Docket No. MT2011-4; Order No. 717] Postal Service Market Test...-filed Postal Service proposal to conduct a limited market test involving a postage-refund guarantee for certain senders of First-Class Mail and Standard Mail. This document describes the proposed test...

78 FR 51678 - Market Tests of Experimental Postal Products

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-21

...] Market Tests of Experimental Postal Products AGENCY: Postal Regulatory Commission. ACTION: Proposed rule... tests of experimental products. The proposed rules address the contents of market test filings, describe... Tests I. Introduction The Commission proposes to establish rules governing market tests of experimental...

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.

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.

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.

The role of the pharmaceutical animal health industry in post-marketing surveillance of resistance.

PubMed

Lens, S

1993-06-01

The pharmaceutical animal health industry must be committed to the total life cycle of products, i.e. during both the pre- and post-marketing period. Support of antibacterial agents during the postmarketing period is not restricted to maintaining a well-established distribution and promotion system. Care has to be taken continuously to maintain and/or improve the quality, safety (for user, target animal and environment) and clinical efficacy. The pharmaceutical industry contributes to this by: 1. Introducing antibacterials in different animal species for the most effective disease condition only and by ensuring the veterinary profession is informed about relevant findings on: a. the mechanism of action; b. pharmacodynamic properties; c. pharmacokinetic properties (plasma, target tissue); d. clinical efficacy data and in vitro sensitivity data; e. valid species-specific MIC breakpoints; f. precise dose and treatment regime. 2. Updating on a regular basis on: a. new findings on the mechanism of action (in vitro and in vivo); b. the optimal use program in the light of changes in animal husbandry, farm management and epidemiology on national and international level; c. adjustment of species-specific MIC breakpoints when necessary. 3. Providing continuous information in collaboration with animal health laboratories about: a. clinical field surveillance for efficacy (national, international); b. in vitro sensitivity/resistance surveillance (national, international); c. use of in vitro data to support prediction of in vivo efficacy. Surveillance of resistance, in vitro, is therefore part of a package of information needed on a routine basis by the pharmaceutical industry to allow the best possible use of antibacterials and to minimize induction of resistance.(ABSTRACT TRUNCATED AT 250 WORDS)

Transitioning from antenatal surveillance surveys to routine HIV testing: a turning point in the mother-to-child transmission prevention programme for HIV surveillance in Brazil.

PubMed

Pereira, Gerson Fernando Mendes; Sabidó, Meritxell; Caruso, Alessandro; Benzaken, Adele Schwartz

2017-07-05

In Brazil, due to the rapid increase in programmes for the prevention of mother-to-child transmission (PMTCT), routine programme data are widely available. The objective of this study was to assess the utility of programmatic data to replace HIV surveillance based on the antenatal care (ANC) surveillance survey (SS). We analysed ANC SS data from 219 maternity service clinics. PMTCT variables were extracted from the ANC SS data collection form, which allowed us to capture and compare the ANC SS data and PMTCT HIV test results for each pregnant woman who completed the ANC SS. Both the PMTCT programme and the ANC SS tested for HIV using sequential ELISA and western blot for confirmation. We assessed the completeness (% missing) of the PMTC data included in the ANC SS. Of the 36,713 pregnant women who had ANC SS HIV tests performed, 30,588 also underwent PMTCT HIV testing. The HIV prevalence rate from routine PMTCT testing was 0.36%, compared to 0.38% from the ANC SS testing (relative difference -0.05%; absolute difference -0.02%). The relative difference in prevalence rates between pregnant women in northern Brazil and pregnant women central-west Brazil was -0.98 and 0.66, respectively. Of the 29,856 women who had HIV test results from both the PMTCT and ANC SS, the positive percent agreement of the PMTCT versus the surveillance test was 84.1% (95% confidence interval [CI]: 74.8-91.0), and the negative percent agreement was 99.9% (95% CI: 99.9-100.0). The PMTCT HIV testing uptake was 86.4%. The ANC SS HIV prevalence was 0.33% among PMTCT non-refusers and 0.59% among refusers, with a percent bias of -10.80% and a differential prevalence ratio of 0.56. Syphilis and HIV testing results were complete in 98% and 97.6% of PMTCT reports, respectively. The reported HIV status for the women at clinic entry was missing. Although there were consistent HIV prevalence estimates from the PMTCT data and the ANC SS, the overall positive percent agreement of 84.1% falls below the

76 FR 71610 - Market Test of First-Class Tracer

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-18

... POSTAL REGULATORY COMMISSION [Docket No. MT2012-1; Order No. 959] Market Test of First-Class... recently-field Postal Service proposal to conduct a market test of a market dominant product, First- Class Tracer. This document describes the proposed test, addresses procedural aspects of the filing, and...

A labelled discrete choice experiment adds realism to the choices presented: preferences for surveillance tests for Barrett esophagus

PubMed Central

2009-01-01

Background Discrete choice experiments (DCEs) allow systematic assessment of preferences by asking respondents to choose between scenarios. We conducted a labelled discrete choice experiment with realistic choices to investigate patients' trade-offs between the expected health gains and the burden of testing in surveillance of Barrett esophagus (BE). Methods Fifteen choice scenarios were selected based on 2 attributes: 1) type of test (endoscopy and two less burdensome fictitious tests), 2) frequency of surveillance. Each test-frequency combination was associated with its own realistic decrease in risk of dying from esophageal adenocarcinoma. A conditional logit model was fitted. Results Of 297 eligible patients (155 BE and 142 with non-specific upper GI symptoms), 247 completed the questionnaire (84%). Patients preferred surveillance to no surveillance. Current surveillance schemes of once every 1–2 years were amongst the most preferred alternatives. Higher health gains were preferred over those with lower health gains, except when test frequencies exceeded once a year. For similar health gains, patients preferred video-capsule over saliva swab and least preferred endoscopy. Conclusion This first example of a labelled DCE using realistic scenarios in a healthcare context shows that such experiments are feasible. A comparison of labelled and unlabelled designs taking into account setting and research question is recommended. PMID:19454022

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.

76 FR 3180 - Market Test of Gift Cards

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-19

... POSTAL REGULATORY COMMISSION [Docket No. MT2011-2; Order No. 647] Market Test of Gift Cards AGENCY... Service proposal to conduct a 2-year market test involving the sale of gift cards. This document describes the proposed test, addresses procedural aspects of the filing, and invites public comment. DATES...

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

A retrospective study of owner-requested testing as surveillance for equine infectious anemia in Canada (2009-2012).

PubMed

Higgins, Sara N; Howden, Krista J; James, Carolyn R; Epp, Tasha; Lohmann, Katharina L

2017-12-01

This retrospective study was undertaken to estimate i) the surveillance coverage for equine infectious anemia (EIA) based on owner-requested testing, and ii) the incidence of case detection from this surveillance activity to inform a review of Canada's national disease control strategy. Based on sample submissions by accredited veterinarians to laboratories CFIA-approved for EIA testing between 2009 and 2012, the estimated national surveillance coverage was 14% for all years, and 72 cases of EIA were detected. The annual national incidence of EIA detection ranged from 0.03 to 0.08 cases/1000 horses. On average, a greater proportion of the horse population was tested in eastern Canada (32%) than in western Canada (6%, P < 0.0001). The cumulative incidence of EIA detection was higher in western Canada (0.25 cases/1000 horses) than in eastern Canada (0.02 cases/1000 horses, P < 0.0001). This study identified regional differences in owner-requested EIA testing and case detection resulting from this testing activity.

Health surveillance for occupational asthma.

PubMed

Fishwick, David; Forman, Steve

2018-04-01

The outcome for workers with occupational asthma is improved for those with an earlier diagnosis. Health surveillance at work is in principle designed to identify such cases, so that the risks to the individual worker, and coworkers, can be reduced. There is recent evidence to suggest that the uptake and quality of such surveillance could be improved. This review has assessed current approaches to health surveillance for occupational asthma. The article covers a review of the utility of questionnaires, lung function testing, immunological investigations, and other tests, including exhaled nitric oxide, sputum eosinophilia, and exhaled breath condensate specifically in the context of workplace-based health surveillance. Questionnaires remain a key component of respiratory health surveillance, although maybe limited by both sensitivity and specificity for early occupational asthma. The role of lung function testing is debated, although is recommended for higher level health surveillance. Various examples of immunological testing in health surveillance are discussed, but more evidence is needed in many specific areas before more general recommendations can be made. Evidence is discussed in relation to the utility of newer approaches such as exhaled nitric oxide, sputum eosinophilia, and exhaled breath condensate.

Uptake of genetic testing and long-term tumor surveillance in von Hippel-Lindau disease

PubMed Central

2010-01-01

Background von Hippel-Lindau (VHL) disease is a hereditary cancer syndrome caused by germline mutations in the VHL gene. Patients have significant morbidity and mortality secondary to vascular tumors. Disease management is centered on tumor surveillance that allows early detection and treatment. Presymptomatic genetic testing is therefore recommended, including in at-risk children. Methods We tested 17 families (n = 109 individuals) for VHL mutations including 43 children under the age of 18. Personalized genetic counseling was provided pre and post-test and the individuals undergoing presymptomatic testing filled out questionnaires gathering socio-demographic, psychological and psychiatric data. Mutation analysis was performed by direct sequencing of the VHL gene. Mutation-carriers were screened for VHL disease-related tumors and were offered follow-up annual examinations. Results Mutations were identified in 36 patients, 17 of whom were asymptomatic. In the initial screening, we identified at least one tumor in five of 17 previously asymptomatic individuals. At the end of five years, only 38.9% of the mutation-carriers continued participating in our tumor surveillance program. During this time, 14 mutation carriers developed a total of 32 new tumors, three of whom died of complications. Gender, education, income, marital status and religiosity were not found to be associated with adherence to the surveillance protocol. Follow-up adherence was also independent of pre-test depression, severity of disease, or number of affected family members. The only statistically significant predictor of adherence was being symptomatic at the time of testing (OR = 5; 95% CI 1.2 - 20.3; p = 0.02). Pre-test anxiety was more commonly observed in patients that discontinued follow-up (64.7% vs. 35.3%; p = 0.01). Conclusions The high initial uptake rate of genetic testing for VHL disease, including in minors, allowed the discontinuation of unnecessary screening procedures in non

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

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

Automated video surveillance: teaching an old dog new tricks

NASA Astrophysics Data System (ADS)

McLeod, Alastair

1993-12-01

The automated video surveillance market is booming with new players, new systems, new hardware and software, and an extended range of applications. This paper reviews available technology, and describes the features required for a good automated surveillance system. Both hardware and software are discussed. An overview of typical applications is also given. A shift towards PC-based hybrid systems, use of parallel processing, neural networks, and exploitation of modern telecomms are introduced, highlighting the evolution modern video surveillance systems.

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. Copyright © 2014 Elsevier B.V. All rights reserved.

78 FR 41128 - Market Test of International Merchandise Return Service

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-09

... POSTAL REGULATORY COMMISSION [Docket No. MT2013-2; Order No. 1771] Market Test of International... noticing a recently-filed Postal Service proposal to conduct a market test of a competitive experimental..., pursuant to 39 U.S.C. 3641, announcing its intent to conduct a market test of a competitive experimental...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-19

... POSTAL SERVICE Market Test of Experimental Product--Metro Post AGENCY: Postal Service TM . ACTION: Notice. SUMMARY: The Postal Service gives notice of a market test of an experimental product in... Service[supreg] hereby gives notice that, pursuant to 39 U.S.C. 3641(c)(1), it will begin a market test of...

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

The cost and cost-effectiveness of rapid testing strategies for yaws diagnosis and surveillance.

PubMed

Fitzpatrick, Christopher; Asiedu, Kingsley; Sands, Anita; Gonzalez Pena, Tita; Marks, Michael; Mitja, Oriol; Meheus, Filip; Van der Stuyft, Patrick

2017-10-01

Yaws is a non-venereal treponemal infection caused by Treponema pallidum subspecies pertenue. The disease is targeted by WHO for eradication by 2020. Rapid diagnostic tests (RDTs) are envisaged for confirmation of clinical cases during treatment campaigns and for certification of the interruption of transmission. Yaws testing requires both treponemal (trep) and non-treponemal (non-trep) assays for diagnosis of current infection. We evaluate a sequential testing strategy (using a treponemal RDT before a trep/non-trep RDT) in terms of cost and cost-effectiveness, relative to a single-assay combined testing strategy (using the trep/non-trep RDT alone), for two use cases: individual diagnosis and community surveillance. We use cohort decision analysis to examine the diagnostic and cost outcomes. We estimate cost and cost-effectiveness of the alternative testing strategies at different levels of prevalence of past/current infection and current infection under each use case. We take the perspective of the global yaws eradication programme. We calculate the total number of correct diagnoses for each strategy over a range of plausible prevalences. We employ probabilistic sensitivity analysis (PSA) to account for uncertainty and report 95% intervals. At current prices of the treponemal and trep/non-trep RDTs, the sequential strategy is cost-saving for individual diagnosis at prevalence of past/current infection less than 85% (81-90); it is cost-saving for surveillance at less than 100%. The threshold price of the trep/non-trep RDT (below which the sequential strategy would no longer be cost-saving) is US$ 1.08 (1.02-1.14) for individual diagnosis at high prevalence of past/current infection (51%) and US$ 0.54 (0.52-0.56) for community surveillance at low prevalence (15%). We find that the sequential strategy is cost-saving for both diagnosis and surveillance in most relevant settings. In the absence of evidence assessing relative performance (sensitivity and specificity

Post-treatment surveillance testing of patients with colorectal cancer and the association with survival: protocol for a retrospective cohort study of the Surveillance, Epidemiology, and End Results (SEER)-Medicare database.

PubMed

Hines, Robert B; Jiban, Md Jibanul Haque; Choudhury, Kanak; Loerzel, Victoria; Specogna, Adrian V; Troy, Steven P; Zhang, Shunpu

2018-04-28

Although the colorectal cancer (CRC) mortality rate has significantly improved over the past several decades, many patients will have a recurrence following curative treatment. Despite this high risk of recurrence, adherence to CRC surveillance testing guidelines is poor which increases cancer-related morbidity and potentially, mortality. Several randomised controlled trials (RCTs) with varying surveillance strategies have yielded conflicting evidence regarding the survival benefit associated with surveillance testing. However, due to differences in study protocols and limitations of sample size and length of follow-up, the RCT may not be the best study design to evaluate this relationship. An observational comparative effectiveness research study can overcome the sample size/follow-up limitations of RCT designs while assessing real-world variability in receipt of surveillance testing to provide much needed evidence on this important clinical issue. The gap in knowledge that this study will address concerns whether adherence to National Comprehensive Cancer Network CRC surveillance guidelines improves survival. Patients with colon and rectal cancer aged 66-84 years, who have been diagnosed between 2002 and 2008 and have been included in the Surveillance, Epidemiology, and End Results-Medicare database, are eligible for this retrospective cohort study. To minimise bias, patients had to survive at least 12 months following the completion of treatment. Adherence to surveillance testing up to 5 years post-treatment will be assessed in each year of follow-up and overall. Binomial regression will be used to assess the association between patients' characteristics and adherence. Survival analysis will be conducted to assess the association between adherence and 5-year survival. This study was approved by the National Cancer Institute and the Institutional Review Board of the University of Central Florida. The results of this study will be disseminated by publishing in

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

PubMed Central

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

2015-01-01

Background Screening and post-symptomatic diagnostic testing are often conflated in cancer screening surveillance research. We examined the error in estimated colorectal cancer (CRC) screening prevalence due to the conflation of screening and diagnostic testing. Methods 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 socio-demographic groups. Results The population screening prevalence was overestimated by 23.3%, and the level of overestimation varied widely across socio-demographic groups (median 22.6%, mean 24.8%). The highest levels of overestimation were in non-Hispanic White females (27.4%), adults ages 50–54 (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-values < 0.001). Conclusions When the impetus for testing was not included, CRC screening prevalence was overestimated, and patterns of overestimation often aligned with social and economic vulnerability. These results are of concern to researchers who utilize 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. Impact 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, in order to craft relevant screening benchmarks and interventions, we must look beyond ‘what’ and ‘when’ and include ‘why.’ PMID:26491056

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.

Risk management and post-marketing surveillance of CNS drugs.

PubMed

Henningfield, Jack E; Schuster, Charles R

2009-12-01

Drugs affecting the central nervous system span a broad range of chemical entities, dosage forms, indications, and risks. Unintended consequences include potential abuse and overdose in non-patient drug abusers, deliberate tampering of drug dosage forms, and criminal behavior associated with diversion. Regulators must consider diverse factors to find the appropriate conditions of approval to minimize unintended consequences while enabling a level of access desired by health care providers and patients. This commentary appears as part of a special issue of Drug and Alcohol Dependence that focuses on risk management and post-marketing surveillance and addresses key issues that pose real-world challenges to pharmaceutical sponsors and regulators in particular. For example, in the U.S., Controlled Substances Act drug scheduling can be considered a risk management strategy but its legal authorities and administrative processes are independent from those of risk management (including Risk Evaluation and Mitigation Strategies or REMS); better harmonization of these approaches is vital from drug development and regulatory perspectives. Risk management would ideally be implemented on a strong science foundation demonstrating that the tools employed to mitigate risks and ensure safe use are effective. In reality, research and evaluation of tools in this area is in its infancy and will necessarily be an evolutionary process; furthermore, there is little precedent for linking interventions and program evolution to unintended consequences such as regional outbreaks of abuse and diversion. How such issues are resolved has the potential to stimulate or stifle innovations in drug development and advance or imperil health care.

Risk management and post-marketing surveillance for the abuse of medications acting on the central nervous system: expert panel report.

PubMed

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

2009-12-01

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 11 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.

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

DTIC Science & Technology

2013-09-01

Ground testing of prototype hardware and processing algorithms for a Wide Area Space Surveillance System (WASSS) Neil Goldstein, Rainer A...at Magdalena Ridge Observatory using the prototype Wide Area Space Surveillance System (WASSS) camera, which has a 4 x 60 field-of-view , < 0.05...objects with larger-aperture cameras. The sensitivity of the system depends on multi-frame averaging and a Principal Component Analysis based image

Performance of diagnostic tests for bovine tuberculosis in North American furbearers and implications for surveillance.

PubMed

O'Brien, D J; Fierke, J S; Cooley, T M; Fitzgerald, S D; Cosgrove, M K; Schmitt, S M

2013-11-01

Risks of bovine tuberculosis (bTB) transmission from free-ranging wildlife to livestock remain a concern in the United States, in both known endemic areas and where spillover from recently-infected livestock herds occurs. Federal agriculture officials in the United States (US) have recommended surveillance of non-cervid furbearers to determine whether free-ranging wildlife in the vicinity of cattle herd breakdowns are bTB infected, yet the efficacy of common diagnostic tests in these species is largely unknown. We calculated the sensitivity, specificity, predictive values and positive likelihood ratios for bTB infection in carcasses of sixteen species of furbearers tested via: (i) the presence of gross lesions compatible with bTB; (ii) histopathology consistent with bTB; and (iii) the presence of acid-fast bacilli (AFB) on histopathology. The gold standard comparison test was mycobacterial culture of cranial ± visceral lymph nodes pooled for each animal. Forty-two animals distributed across six species cultured bTB positive from among 1522 furbearers tested over thirteen years. The sensitivity of all three tests was poor (10%, 22% and 24% for gross lesions, AFB and histopathology, respectively), while specificities (all ≥ 99%) and negative predictive values (all ≥ 97%) were high. Positive predictive values varied widely (31-75%). Likelihood ratios for culture positivity given a positive test result showed AFB on histopathology to be the most reliable test, and gross lesions the least, though confidence intervals were wide and overlapping. While non-cervid furbearers may prove useful in North American bTB surveillance, wildlife managers should be aware of factors that may abate their utility and complicate interpretation of surveillance. © 2013 Blackwell Verlag GmbH.

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

PubMed

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

2015-01-01

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

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

PubMed Central

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

2015-01-01

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

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-18

... POSTAL SERVICE Market Test of Experimental Product: ``Gift Cards'' AGENCY: Postal Service \\TM\\. ACTION: Notice. SUMMARY: The Postal Service gives notice of a market test of an experimental product in... notice pursuant to 39 U.S.C. 3641(c)(1) that it will begin a market test of its ``Gift Cards...

No increase in HIV or sexually transmissible infection testing following a social marketing campaign among men who have sex with men.

PubMed

Guy, R; Goller, J; Leslie, D; Thorpe, R; Grierson, J; Batrouney, C; Kennedy, M; Lewis, J; Fairley, C; Ginige, S; Zablotska, I; Hellard, M

2009-05-01

A social marketing campaign ran in 2004 in the Victoria to increase rates of HIV/sexually transmissible infection (STI) testing among men having sex with men (MSM). To evaluate the initiative data from HIV sentinel surveillance, laboratory data on testing for HIV/STIs and STI/HIV testing uptake reported in annual surveys were analysed. The sentinel surveillance network showed no increase in the overall extent of HIV testing and no difference in the proportion of MSM reporting regular annual HIV testing during the campaign (43%) and post campaign (41%). The annual behavioural surveys showed that between 2004 and 2006 there was no significant increase in this overall proportion of MSM reporting having an HIV test in the last 12 months (p = 0.96). The behavioural surveys also showed an increasing trend in the proportion reporting specific STI tests over time: anal swab (26% to 39%, ptest (42% to 50%, ptesting at the clinics detected through the laboratory reports: chlamydia (average increment of 6.4 tests per month, p<0.01), gonorrhoea (6.5 tests per month, ptests per month, ptesting. These findings highlight the importance of evaluating public health campaigns to assess their impact to ensure that they are modified if no impact is identified.

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

2017-10-17

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

A temporal interestingness measure for drug interaction signal detection in post-marketing surveillance.

PubMed

Ji, Yanqing; Ying, Hao; Tran, John; Dews, Peter; Mansour, Ayman; Massanari, R Michael

2014-01-01

Drug-drug interactions (DDIs) can result in serious consequences, including death. Existing methods for identifying potential DDIs in post-marketing surveillance primarily rely on the FDA's (Food and Drug Administration) spontaneous reporting system. However, this system suffers from severe underreporting, which makes it difficult to timely collect enough valid cases for statistical analysis. In this paper, we study how to signal potential DDIs using patient electronic health data. Specifically, we focus on discovery of potential DDIs by analyzing the temporal relationships between the concurrent use of two drugs of interest and the occurrences of various symptoms using novel temporal association mining techniques we developed. A new interestingness measure called functional temporal interest was proposed to assess the degrees of temporal association between two drugs of interest and each symptom. The measure was employed to screen potential DDIs from 21,405 electronic patient cases retrieved from the Veterans Affairs Medical Center in Detroit, Michigan. The preliminary results indicate the usefulness of our method in finding potential DDIs for further analysis (e.g., epidemiology study) and investigation (e.g., case review) by drug safety professionals.

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

Targeting as the basis for pre-test market of lithium-ion battery

NASA Astrophysics Data System (ADS)

Yuniaristanto, Zakaria, R.; Saputri, V. H. L.; Sutopo, W.; Kadir, E. A.

2017-11-01

This article discusses about market segmentation and targeting as a first step in pre-test market of a new technology. The benefits of targeting towards pre-test market are pre-test market can be conducted to focus on selected target markets so there is no bias during the pre-test market. In determining the target market then do some surveys to identify the state of market in the future, so that the marketing process is not misplaced. Lithium ion battery which is commercialized through start-up companies is the case study. This start-up companies must be able to respond the changes and bring in customers as well as maintain them so that companies can survive and evolve to achieve its objectives. The research aims to determine market segments and target market effectively. Marketing strategy (segmentation and targeting) is used to make questionnaire and cluster analysis in data processing. Respondents were selected by purposive sampling and have obtained data as many as 80 samples. As the results study, there are three segments for lithium ion battery with their own distinguished characteristics and there are two segments that can be used as the target market for the company.

Clinical Safety and Tolerability of Vildagliptin - Insights from Randomised Trials, Observational Studies and Post-marketing Surveillance.

PubMed

Mathieu, Chantal; Kozlovski, Plamen; Paldánius, Päivi M; Foley, James E; Modgill, Vikas; Evans, Marc; Serban, Carmen

2017-08-01

Vildagliptin is one of the most extensively studied dipeptidyl peptidase-4 (DPP-4) inhibitors in terms of its clinical utility. Over the last decade, a vast panorama of evidence on the benefit-risk profile of vildagliptin has been generated in patients with type 2 diabetes mellitus (T2DM). In this article, we review the cumulative evidence on the safety of vildagliptin from the clinical development programme, as well as reports of rare adverse drug reactions detected during the post-marketing surveillance of the drug. Across clinical studies, the overall safety and tolerability profile of vildagliptin was similar to placebo, and it was supported by real-world data in a broad population of patients with T2DM, making DPP-4 inhibitors, like vildagliptin, a safe option for managing patients with T2DM.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-22

... Metro Post. This document describes the proposed test, addresses procedural aspects of the filing, and.... \\1\\ Notice of the United States Postal Service of Market Test of Experimental Product--Metro Post... the Metro Post market test under seal. Notice at 4. The Postal Service classifies Metro Post as a...

Demonstration testing of a surveillance robot at Browns Ferry Nuclear Plant: Analysis of costs and benefits

DOE Office of Scientific and Technical Information (OSTI.GOV)

White, J.R.; Farnstrom, K.A.; Harvey, H.W.

1987-03-01

This report presents the results of an NRC project to determine whether robotics equipment can be cost effective in performing surveillance and inspection work at existing nuclear power plants. A mobile surveillance robot, called SURBOT, was developed by the Remote Technology Corporation (REMOTEC) to perform visual, sound, and radiation surveillance within rooms designated as radiologically hazardous. SURBOT was tested in the turbine building of the Browns Ferry Nuclear Plant (BFNP) by TVA personnel for a five-month period. The results showed that SURBOT obtains higher quality data and can perform more thorough surveillance within radiation areas than workers wearing protective clothing.more » SURBOT can be transferred between rooms without releasing contamination in the hallways using a portable enclosure. TVA has estimated that over 100 person-rem exposure and $100,000 operating costs can be saved annually at the BFNP using SURBOT for surveillance in 54 turbine and reactor building rooms. TVA recommendations for improving the function, reliability, and maintainability have been incorporated into a production model of SURBOT which is now commercially available from REMOTEC along with other types of mobile robots and manipulators.« less

75 FR 70753 - Market Test Involving Greeting Cards

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-18

... businesses will produce and distribute pre-approved envelopes according to specific design requirements which... will produce and distribute pre-approved envelopes with specific design requirements that will be... a market test beginning on or about January 1, 2011, of an experimental market dominant product...

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.

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…

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-13

... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPPT-2010-0990; FRL-8857-3] Approval of Test Marketing...: This notice announces EPA's approval of applications for test marketing exemptions (TMEs) under section... test marketing conditions are described in the TME applications and in this notice. DATES: Approval of...

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...for surveillance even though I was unable to attend his workshop. J.D. Malone’s tremendous knowledge of both infectious diseases and the DoD...can reduce morbidity and mortality. The course of many infectious diseases includes a nonspecific prodrome in which symptoms of the disease may be

A Japanese Post-marketing Surveillance of Cetuximab (Erbitux®) in Patients with Metastatic Colorectal Cancer

PubMed Central

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

2012-01-01

Objective 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. Methods 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. Results 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. Conclusions 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. PMID:22327124

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

PubMed

Saeed, Abdulaziz A Bin; Abedi, Glen R; 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

2017-04-01

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.

Influenza testing trends in sentinel surveillance general practices in Victoria 2007 to 2014.

PubMed

Cowie, Genevieve A; Cowie, Benjamin C; Fielding, James E

2017-03-31

The Victorian Sentinel Practice Influenza Network conducts syndromic surveillance for influenza-like illness (ILI), with testing for laboratory confirmation of a proportion of cases at the discretion of general practitioners. The aim of this study was to evaluate the consistency of sentinel general practitioners' swabbing practice within and between influenza seasons. Aggregated, weekly, non-identified data for May to October each year from 2007 to 2014 were used to calculate the proportion of patients presenting with ILI (defined as cough, fever and fatigue), proportion of ILI patients swabbed and proportion of swabs positive for influenza. Data on the proportion of consultations for ILI and the proportion of ILI patients swabbed were aggregated into time-period quintiles for each year. Analysis of variance was used to compare ILI patients swabbed for each aggregated time-period quintile over all 8 years. Spearman's correlation and Bland-Altman analyses were used to measure association and agreement respectively between ILI proportions of consultations and swabs positive for influenza in time period quintiles within each year. Data were aggregated by year for the rest of the analyses. Between 2007 and 2014 there was a slight decrease in the proportion of positive tests and the proportion of ILI patients was generally a good proxy for influenza test positivity. There was consistency in testing within and between seasons, despite an overall testing increase between 2007 and 2014. There was no evidence for temporal sampling bias in these data despite testing not being performed on a systematic basis. This sampling regimen could also be considered in other similar surveillance systems.

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

2017-12-01

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 © 2017 John Wiley & Sons, Ltd. © 2017 Commonwealth of Australia. Pharmacoepidemiology

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. © 2015 Blackwell Verlag GmbH.

Health surveillance of preschool children.

PubMed Central

Colver, A F; Steiner, H

1986-01-01

Discussions with every general practice, health visitor, and clinical medical officer in Northumberland Health Authority led to agreement about the content of preschool health surveillance, the ages at which it should be done, and referral pathways after a failed screening test. Each primary health care team now undertakes to do a basic minimum set of screening tests, and each team decides who in the team will do each test. The screening system agreed on should enable time to become available for the equally important aspects of surveillance--namely, developmental guidance, health education, and assessment and follow up of problems. The discussions also led to agreement about how the health authority should evaluate the effect of the surveillance programme on the health of children. PMID:2425884

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.

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.

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

Use of national pneumonia surveillance to describe influenza A(H7N9) virus epidemiology, China, 2004-2013.

PubMed

Xiang, Nijuan; Havers, Fiona; Chen, Tao; Song, Ying; Tu, Wenxiao; Li, Leilei; Cao, Yang; Liu, Bo; Zhou, Lei; Meng, Ling; Hong, Zhiheng; Wang, Rui; Niu, Yan; Yao, Jianyi; Liao, Kaiju; Jin, Lianmei; Zhang, Yanping; Li, Qun; Widdowson, Marc-Alain; Feng, Zijian

2013-11-01

In mainland China, most avian influenza A(H7N9) cases in the spring of 2013 were reported through the pneumonia of unknown etiology (PUE) surveillance system. To understand the role of possible underreporting and surveillance bias in assessing the epidemiology of subtype H7N9 cases and the effect of live-poultry market closures, we examined all PUE cases reported from 2004 through May 3, 2013. Historically, the PUE system was underused, reporting was inconsistent, and PUE reporting was biased toward A(H7N9)-affected provinces, with sparse data from unaffected provinces; however, we found no evidence that the older ages of persons with A(H7N9) resulted from surveillance bias. The absolute number and the proportion of PUE cases confirmed to be A(H7N9) declined after live-poultry market closures (p<0.001), indicating that market closures might have positively affected outbreak control. In China, PUE surveillance needs to be improved.

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.

Testing neoclassical competitive market theory in the field

PubMed Central

List, John A.

2002-01-01

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. PMID:12432103

Panitumumab in Japanese Patients with Unresectable Colorectal Cancer: A Post-marketing Surveillance Study of 3085 Patients†

PubMed Central

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

2014-01-01

Objective 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. Methods 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. Results 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. Conclusion 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. PMID:24526771

[Current status of gene test market].

PubMed

Ohtani, Shinichi

2002-12-01

The technological innovation of the gene analysis makes the adaptation range of the gene test in clinical diagnosis expand. Then, gene test has popularized increasingly around the infection disease for clinical inspection. Also in the field of clinical inspection, the increase of the importance of clinical application and the inspection item new year by year have appeared with the functional analysis of a gene. Moreover, the new test method and automation analysis equipment tend to be developed by progress of gene-analysis technology, and it is going to be introduced. The spread of gene test and development of a gene test market have an important possibility of activating the present clinical inspection field.

Compressed television transmission: A market survey

NASA Technical Reports Server (NTRS)

Lizak, R. M.; Cagan, L. Q.

1981-01-01

NASA's compressed television transmission technology is described, and its potential market is considered; a market that encompasses teleconferencing, remote medical diagnosis, patient monitoring, transit station surveillance, as well as traffic management and control. In addition, current and potential television transmission systems and their costs and potential manufacturers are considered.

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.

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

2008 Nevada Test Site Annual Illness and Injury Surveillance Report

DOE Office of Scientific and Technical Information (OSTI.GOV)

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.

2007 Nevada Test Site Annual Illness and Injury Surveillance Report

DOE Office of Scientific and Technical Information (OSTI.GOV)

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.

2006 Nevada Test Site Annual Illness and Injury Surveillance Report

DOE Office of Scientific and Technical Information (OSTI.GOV)

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.

Salmonella enteritidis surveillance by egg immunology: impact of the sampling scheme on the release of contaminated table eggs.

PubMed

Klinkenberg, Don; Thomas, Ekelijn; Artavia, Francisco F Calvo; Bouma, Annemarie

2011-08-01

Design of surveillance programs to detect infections could benefit from more insight into sampling schemes. We address the effect of sampling schemes for Salmonella Enteritidis surveillance in laying hens. Based on experimental estimates for the transmission rate in flocks, and the characteristics of an egg immunological test, we have simulated outbreaks with various sampling schemes, and with the current boot swab program with a 15-week sampling interval. Declaring a flock infected based on a single positive egg was not possible because test specificity was too low. Thus, a threshold number of positive eggs was defined to declare a flock infected, and, for small sample sizes, eggs from previous samplings had to be included in a cumulative sample to guarantee a minimum flock level specificity. Effectiveness of surveillance was measured by the proportion of outbreaks detected, and by the number of contaminated table eggs brought on the market. The boot swab program detected 90% of the outbreaks, with 75% fewer contaminated eggs compared to no surveillance, whereas the baseline egg program (30 eggs each 15 weeks) detected 86%, with 73% fewer contaminated eggs. We conclude that a larger sample size results in more detected outbreaks, whereas a smaller sampling interval decreases the number of contaminated eggs. Decreasing sample size and interval simultaneously reduces the number of contaminated eggs, but not indefinitely: the advantage of more frequent sampling is counterbalanced by the cumulative sample including less recently laid eggs. Apparently, optimizing surveillance has its limits when test specificity is taken into account. © 2011 Society for Risk Analysis.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-02

... POSTAL SERVICE Market Test of ``Samples Co-Op Box'' Experimental Product AGENCY: Postal Service TM . ACTION: Notice. SUMMARY: The Postal Service gives notice of a market test of an experimental product in... pursuant to 39 U.S.C. 3641(c)(1) that it will begin a market test of its ``Samples Co-Op Box'' experimental...

A new approach to the use of α-fetoprotein as surveillance test for hepatocellular carcinoma in patients with cirrhosis

PubMed Central

Biselli, M; Conti, F; Gramenzi, A; Frigerio, M; Cucchetti, A; Fatti, G; D'Angelo, M; Dall'Agata, M; Giannini, E G; Farinati, F; Ciccarese, F; Andreone, P; Bernardi, M; Trevisani, F

2015-01-01

Background: Surveillance for hepatocellular carcinoma (HCC) is recommended in patients with cirrhosis. As α-fetoprotein (AFP) is considered a poor surveillance test, we tested the performance of its changes over time. Methods: Eighty patients were diagnosed with HCC (cases) during semiannual surveillance with ultrasonography and AFP measurement were recruited and matched for age, gender, etiology and Child-Pugh class with 160 contemporary cancer-free controls undergoing the same surveillance training group (TG). As a validation group (VG) we considered 36 subsequent patients diagnosed with HCC, matched 1 : 3 with contemporary cancer-free controls. α-Fetoprotein values at the time of HCC diagnosis (T0) and its changes over the 12 (Δ12) and 6 months (Δ6) before cancer detection were considered. Results: In both TG and VG, >80% of HCCs were found at an early stage. In TG, AFP significantly increased over time only in cases. T0 AFP and a positive Δ6 were independently associated with HCC diagnosis (odds ratio: 1.031 and 2.402, respectively). The area under the curve of T0 AFP was 0.76 and its best cutoff (BC) was 10 ng ml−1 (sensitivity 66.3%, specificity 80.6%). The combination of AFP >10 ng ml−1 or a positive Δ6 composite α-fetoprotein index (CAI) increased the sensitivity to 80% with a negative predictive value (NPV) of 86.2%. Negative predictive value rose to 99%, considering a cancer prevalence of 3%. In the VG, the AFP-BC was again 10 ng ml−1 (sensitivity 66.7%, specificity 88.9%), and CAI sensitivity was 80.6% with a NPV value of 90.5%. Conclusions: CAI achieves adequate sensitivity and NPV as a surveillance test for the early detection of HCC in cirrhosis. PMID:25314061

Intussusception following rotavirus vaccine administration: post-marketing surveillance in the National Immunization Program in Australia.

PubMed

Buttery, J P; Danchin, M H; Lee, K J; Carlin, J B; McIntyre, P B; Elliott, E J; Booy, R; Bines, J E

2011-04-05

In Australia, post-marketing surveillance for intussusception following vaccination commenced with funding of RotaTeq(®) and Rotarix(®) vaccines under the National Immunization Program (NIP) in July 2007. Two active surveillance mechanisms (hospital-based case ascertainment and monthly reports from paediatricians) identified intussusception cases between 1st July 2007 and 31st December 2008 in four states. Linkage to vaccination records identified cases occurring within 1-7 and 1-21 days of rotavirus vaccination. Expected cases within the post-vaccination windows were calculated by applying rates of intussusception from national hospitalisation data over 6 years (mid-2000 to mid-2006), by age and state, to numbers vaccinated (by dose) according to the Australian Childhood Immunization Register. Combining exposure windows associated with all doses of rotavirus vaccine from 1 to 9 months of age, there was no evidence of an increased risk of intussusception following vaccination for either vaccine. However, in infants 1 to <3 months of age, there was suggestive evidence of excess intussusception cases 1-7 and 1-21 days following dose 1 (1-7 days: RotaTeq(®) relative risk (RR)=5.3, 95% confidence interval [CI] 1.1,15.4; Rotarix(®) RR 3.5, 95% CI 0.7,10.1; 1-21 days: RotaTeq(®) RR 3.5, 95% CI 1.3, 7.6; Rotarix(®)RR 1.5, 95% CI 0.4, 3.9). There was no evidence that clinical outcome of intussusception occurring within 21 days of rotavirus vaccination differed from that in cases occurring later post-vaccination. Although we found no overall increase in intussusception following receipt of rotavirus vaccine, there was some evidence of an elevated risk following the first dose of both vaccines. Larger population-based studies using linked databases are required to provide more definitive evidence. Copyright © 2011 Elsevier Ltd. All rights reserved.

A post-market surveillance analysis of the safety of hydroxyapatite-derived products as bone graft extenders or substitutes for spine fusion.

PubMed

Barbanti Brodano, G; Griffoni, C; Zanotti, B; Gasbarrini, A; Bandiera, S; Ghermandi, R; Boriani, S

2015-10-01

Iliac crest bone graft (ICBG) is considered the gold standard for spine surgical procedures to achieve a successful fusion, because of its known osteoinductive and osteoconductive properties. Considering its autogenous origin, the use of ICBG has not been associated to an increase of intraoperative or postoperative complications directly related to the surgery. However, complications related to the harvesting procedure and to the donor site morbidity have been largely reported in the literature, favoring the development of a wide range of alternative products to be used as bone graft extenders or substitutes for spine fusion. The family of ceramic-based bone grafts has been widely used and studied during the last years for spine surgical procedures in order to reduce the need for iliac crest bone grafting and the consequent morbidity associated to the harvesting procedures. We report here the results of a post-market surveillance analysis performed on four independent cohorts of patients (115 patients) to evaluate the safety of three different formulations of hydroxyapatite-derived products used as bone graft extenders/substitutes for lumbar arthrodesis. No intraoperative or post-operative complications related to the use of hydroxyapatite-derived products were detected, during medium and long follow up period (minimum 12 months-maximum 5 years). This post-market surveillance analysis evidenced the safety of ceramic products as bone graft extenders or substitutes for spine fusion. Moreover, the evidence of the safety of hydroxyapatite-derived products allows to perform clinical studies aimed at evaluating the fusion rates and the clinical outcomes of these materials as bone graft extenders/substitutes, in order to support their use as an alternative to ICBG for spine fusion.

Results of a customer-based, post-market surveillance survey of the HeRO access device.

PubMed

Fusselman, Maureen

2010-08-01

In order to supplement post-market surveillance data on the HeRO vascular access device, a non-scientific customer survey was conducted to obtain quantitative data from dialysis providers caring for patients implanted with the device. Dialysis nurses involved in the care of HeRO patients were contacted in order to obtain post-implant device performance information for 10% of patients implanted with the device at the time of the survey. Thirty-eight dialysis units with a total of 65 HeRO patients participated in the survey. The total duration of HeRO device use was 348.4 months with an average use of 5.4 months. Thirty-eight of the 65 HeRO patients (58.5%) were reported to not have experienced any performance issues. There were 28 device performance incidents reported for the remaining 27 patients included in the survey. Occlusion was the single most commonly reported device-related performance issue with 18 patients (27.7%) experiencing 25 occlusive episodes. The majority of the patients who had an occlusion (66.7%) only experienced one occlusive event. Infections occurred in 4 patients (6.2%) with an overall infection rate of 0.38 per 1,000 patient days. Post-market clinical experience during the first 18 months of commercialization of the HeRO device were in line with expectations based on the results from initial clinical studies with the device. Device occlusion remains the most commonly reported performance issue with the reported rate in this survey less than that which was reported in earlier published studies with the device.

Modernization of existing VVER-1000 surveillance programs

DOE Office of Scientific and Technical Information (OSTI.GOV)

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 surveillancemore » 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)« less

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.

76 FR 25381 - Postal Service Market Test

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-04

... AGENCY: Postal Regulatory Commission. ACTION: Notice. SUMMARY: The Commission is noticing a recently-filed Postal Service motion for a temporary extension of the Collaborative Logistics experimental market test, pending Commission action on anticipated request for permanent status. This document grants a one...

[Surveillance of susceptibility of clinical isolates to cefmetazole between 2000 and 2003].

PubMed

Sato, Yuki; Abe, Tomomi; Koga, Tetsufumi; Ito, Kazuyoshi; Tochikawa, Yuko

2005-06-01

For the post-marketing surveillance of cefmetazole (CMZ, Cefmetazon), MICs of injectable beta-lactam antibacterials including CMZ against clinical isolates from 15 medical institutions all over Japan are measured yearly and the incidence rates of resistance in various species are also evaluated. In the first surveillance from June 2000 to March 2001, 574 isolates of 13 species were tested, 548 isolates of the same 13 species were tested in the second surveillance from April 2001 to March 2002, and 654 isolates of the same 13 species were tested in the third surveillance from April 2002 to March 2003. No remarkable changes in the activity of CMZ were observed in these surveillances spanning three years. The activity of CMZ in this study was comparable to that in the studies conducted before Cefmetazon was launched. This result suggests that CMZ still maintains potent activity. Changes in percent resistance of each species to CMZ (MIC of CMZ > or = 32 microg/ml) were as follows: methicillin-susceptible Staphylococcus aureus (MSSA, 0.0% --> 0.0% --> 0.0%), methicillin-resistant Staphylococcus aureus (MRSA, 72.9% --> 87.2% --> 88.7%), Staphylococcus epidermidis (18.5% --> 31.6% --> 14.3%), coagulase-negative Staphylococcus spp. (CNS, 13.3% --> 18.2% --> 21.4%), Escherichia coli (3.6% --> 0.8% --> 2.1%), Klebsiella pneumoniae (3.4% --> 3.8% --> 2.1%), Klebsiella oxytoca (0.0% --> 0.0% --> 0.0%), Proteus mirabilis (2.3% --> 2.1% --> 0.0%), Proteus vulgaris (13.6% --> 6.7% --> 0.0%), Morganella morganii (7.3% --> 0.0% --> 14.0%), Providencia spp. (12.5% --> 0.0% --> 18.2%), Peptostreptococcus spp. (0.0% --> 0.0% --> 0.0%), Bacteroides fragilis (10.3% --> 10.8% --> 17.1%), Bacteroides spp. (78.6% --> 87.5% --> 62.5%). The Change in percent resistance of MRSA, other CNS, and B. flagiris tended to increase. It is necessary to pay much attention to trends observed in these species. Compared to other drugs tested, against MSSA, the activity of CMZ was inferior to that of CEZ

Parametric and nonparametric Granger causality testing: Linkages between international stock markets

NASA Astrophysics Data System (ADS)

De Gooijer, Jan G.; Sivarajasingham, Selliah

2008-04-01

This study investigates long-term linear and nonlinear causal linkages among eleven stock markets, six industrialized markets and five emerging markets of South-East Asia. We cover the period 1987-2006, taking into account the on-set of the Asian financial crisis of 1997. We first apply a test for the presence of general nonlinearity in vector time series. Substantial differences exist between the pre- and post-crisis period in terms of the total number of significant nonlinear relationships. We then examine both periods, using a new nonparametric test for Granger noncausality and the conventional parametric Granger noncausality test. One major finding is that the Asian stock markets have become more internationally integrated after the Asian financial crisis. An exception is the Sri Lankan market with almost no significant long-term linear and nonlinear causal linkages with other markets. To ensure that any causality is strictly nonlinear in nature, we also examine the nonlinear causal relationships of VAR filtered residuals and VAR filtered squared residuals for the post-crisis sample. We find quite a few remaining significant bi- and uni-directional causal nonlinear relationships in these series. Finally, after filtering the VAR-residuals with GARCH-BEKK models, we show that the nonparametric test statistics are substantially smaller in both magnitude and statistical significance than those before filtering. This indicates that nonlinear causality can, to a large extent, be explained by simple volatility effects.

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

A post-marketing safety and efficacy assessment of a monoclonal antibody purified high-purity factor VIII concentrate.

PubMed

Hay, C R; Lee, C A; Savidge, G

1996-01-01

The identification of infrequent side-effects of clotting factor concentrates, undetected by clinical trials, is facilitated by post-marketing surveillance. We present a post-marketing surveillance study in which 97 patients with haemophilia A, attending three haemophilia centres, were treated over a median follow-up period of 284 days (range 1-1074), and a total follow-up period of 30,080 days, with a pasteurized immunoaffinity purified factor VIII concentrate (Monoclate-P, Armour, Collegeville, USA). 5216 infusions, using 10,527,000 units of Monoclate-P, were carried out, mostly for routine haemarthroses or prophylaxis. No new inhibitors were observed during the study. At the start of the study 60/97 were HIV seropositive, 67/97 HBs antibody positive, 12 HbsAb negative and the remainder HBsAb positive before the study period. 13/14 tested were HAV seropositive at the beginning of the study. One patient became HAV seropositive during the study period, an infection thought to be community acquired. No other seroconversions were observed. Only one mild transfusion reaction was observed. This study confirms the safety and efficacy of Monoclate-P. Post-marketing surveillance or nationally organized pharmaco-vigilance should be practiced more widely to enable identification of low-frequency side-effects of treatment.

Comparison of results of fluconazole disk diffusion testing for Candida species with results from a central reference laboratory in the ARTEMIS global antifungal surveillance program.

PubMed

Pfaller, M A; Hazen, K C; Messer, S A; Boyken, L; Tendolkar, S; Hollis, R J; Diekema, D J

2004-08-01

The accuracy of antifungal susceptibility tests is important for accurate resistance surveillance and for the clinical management of patients with serious infections. Our main objective was to compare the results of fluconazole disk diffusion testing of Candida spp. performed by ARTEMIS participating centers with disk diffusion and MIC results obtained by the central reference laboratory. A total of 2,949 isolates of Candida spp. were tested by NCCLS disk diffusion and reference broth microdilution methods in the central reference laboratory. These results were compared to the results of disk diffusion testing performed in the 54 participating centers. All tests were performed and interpreted following NCCLS recommendations. Overall categorical agreement between participant disk diffusion test results and reference laboratory MIC results was 87.4%, with 0.2% very major errors (VME) and 3.3% major errors (ME). The categorical agreement between the disk diffusion test results obtained in the reference laboratory with the MIC test results was similar: 92.8%. Likewise, good agreement was observed between participant disk diffusion test results and reference laboratory disk diffusion test results: 90.4%, 0.4% VME, and 3.4% ME. The disk diffusion test was especially reliable in detecting those isolates of Candida spp. that were characterized as resistant by reference 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 practices.

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

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.

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.

40 CFR 52.533 - Source surveillance.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 3 2014-07-01 2014-07-01 false Source surveillance. 52.533 Section 52.533 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS Florida § 52.533 Source surveillance. The plan lacks test...

40 CFR 52.533 - Source surveillance.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 3 2010-07-01 2010-07-01 false Source surveillance. 52.533 Section 52.533 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS Florida § 52.533 Source surveillance. The plan lacks test...

40 CFR 52.533 - Source surveillance.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 3 2012-07-01 2012-07-01 false Source surveillance. 52.533 Section 52.533 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS Florida § 52.533 Source surveillance. The plan lacks test...

40 CFR 52.533 - Source surveillance.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 3 2013-07-01 2013-07-01 false Source surveillance. 52.533 Section 52.533 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS Florida § 52.533 Source surveillance. The plan lacks test...

40 CFR 52.533 - Source surveillance.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 3 2011-07-01 2011-07-01 false Source surveillance. 52.533 Section 52.533 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS Florida § 52.533 Source surveillance. The plan lacks test...

Evaluation of the novel respiratory virus surveillance program: Pediatric Early Warning Sentinel Surveillance (PEWSS).

PubMed

Armour, Patricia A; Nguyen, Linh M; Lutman, Michelle L; Middaugh, John P

2013-01-01

Infections caused by respiratory viruses are associated with recurrent epidemics and widespread morbidity and mortality. Routine surveillance of these pathogens is necessary to determine virus activity, monitor for changes in circulating strains, and plan for public health preparedness. The Southern Nevada Health District in Las Vegas, Nevada, recruited five pediatric medical practices to serve as sentinel sites for the Pediatric Early Warning Sentinel Surveillance (PEWSS) program. Sentinel staff collected specimens throughout the year from ill children who met the influenza-like illness case definition and submitted specimens to the Southern Nevada Public Health Laboratory for molecular testing for influenza and six non-influenza viruses. Laboratory results were analyzed and reported to the medical and general communities in weekly bulletins year-round. PEWSS data were also used to establish viral respiratory seasonal baselines and in influenza vaccination campaigns. The surveillance program was evaluated using the Centers for Disease Control and Prevention's (CDC's) Updated Guidelines for Evaluating Public Health Surveillance Systems. PEWSS met three of six program usefulness criteria and seven of nine surveillance system attributes, which exceeded the CDC Guidelines evaluation criteria for a useful and complete public health surveillance program. We found that PEWSS is a useful and complete public health surveillance system that is simple, flexible, accessible, and stable.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-16

... POSTAL SERVICE Market Test of Experimental Product: ``First-Class Tracer'' AGENCY: Postal Service \\TM\\. ACTION: Notice. SUMMARY: The Postal Service gives notice of a market test of an experimental... ``First-Class Tracer'' experimental product on or after December 7, 2011. The Postal Service has filed...

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

2017-06-01

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. © 2015 The Authors. Transboundary and Emerging Diseases Published by Blackwell Verlag GmbH.

Current French system of post-marketing drug surveillance.

PubMed

Albengres, E; Gauthier, F; Tillement, J P

1990-07-01

The French system of drug surveillance is characterized by several original features: thirty regional centres are selected to cover all of France to collect, analyze and enter the adverse drug events in the national data bank. The system is based on a bank of well documented files submitted to a decision of imputation; the report of severe events by prescribers is mandatory; cases are collected either by spontaneous reporting (routine) or by direct request (intensive validation study); the system is being involved in studies of epidemiological type as carried out by the national system of health or a few societies of medicine as well as by the centres themselves in cooperative works on defined populations.

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.

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).

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

Semiparametric Bayesian commensurate survival model for post-market medical device surveillance with non-exchangeable historical data.

PubMed

Murray, Thomas A; Hobbs, Brian P; Lystig, Theodore C; Carlin, Bradley P

2014-03-01

Trial investigators often have a primary interest in the estimation of the survival curve in a population for which there exists acceptable historical information from which to borrow strength. However, borrowing strength from a historical trial that is non-exchangeable with the current trial can result in biased conclusions. In this article we propose a fully Bayesian semiparametric method for the purpose of attenuating bias and increasing efficiency when jointly modeling time-to-event data from two possibly non-exchangeable sources of information. We illustrate the mechanics of our methods by applying them to a pair of post-market surveillance datasets regarding adverse events in persons on dialysis that had either a bare metal or drug-eluting stent implanted during a cardiac revascularization surgery. We finish with a discussion of the advantages and limitations of this approach to evidence synthesis, as well as directions for future work in this area. The article's Supplementary Materials offer simulations to show our procedure's bias, mean squared error, and coverage probability properties in a variety of settings. © 2013, The International Biometric Society.

Surveillance on The Safety and Efficacy of Ambrisentan (Volibris Tablet 2.5 mg) in Patients with Pulmonary Arterial Hypertension in Real Clinical Practice: Post-marketing Surveillance (Interim Analysis Report).

PubMed

Takahashi, Tomohiko; Hayata, Satoru; Kobayashi, Akihiro; Onaka, Yuna; Ebihara, Takeshi; Hara, Terufumi

2018-03-01

Pulmonary arterial hypertension (PAH) is an intractable and rare disease and the accumulation of clinical evidence under real-world setting is needed. A post-marketing surveillance for the endothelin receptor antagonist ambrisentan (Volibris tablet) has been conducted by all-case investigation since September 2010. This paper is an interim report on the safety and efficacy of ambrisentan in 702 patients with PAH. PAH patients aged 15 years or older were subjected to the analysis. The safety analysis by overall cases or stratification of patient backgrounds and the efficacy analysis were investigated. Regarding patient characteristics, the 702 patients subjected to safety analysis included 543 (77.4%) women and 546 (77.8%) patients at WHO functional class II/III. The mean observational time was 392.7 days. A total of 324 adverse drug reaction (ADR) occurred in 204 (29.1%) patients. Common ADRs (≥ 2%) included anemia (4.6%), peripheral edema (4.1%), headache (3.6%), edema and face edema (2.6% each), abnormal hepatic function (2.3%), and epistaxis (2.1%). There were 82 serious ADRs occurring in 44 (6.3%) patients (385 serious adverse events in 184 (26.2%) patients). Although 11 (1.6%) interstitial lung disease (ILD) cases were reported, all were observed in patients with disease that may contribute to ILD and therefore it is difficult to assess if ambrisentan was associated with these events. There was no difference in safety in relation to the presence/absence of connective tissue disease-related PAH (CTD-PAH) or combination therapy. Among 677 patients subjected to efficacy analysis, those in whom hemodynamic status was determined before and after treatment showed improvement in the mean pulmonary arterial pressure and pulmonary vascular resistance after treatment. The interim results showed safety consistent with the known profile of ambrisentan in terms of the types and frequencies of ADRs in patients with PAH in real clinical practice, in comparison with

Pharmaceutical marketing research and the prescribing physician.

PubMed

Greene, Jeremy A

2007-05-15

Surveillance of physicians' prescribing patterns and the accumulation and sale of these data for pharmaceutical marketing are currently the subjects of legislation in several states and action by state and national medical associations. Contrary to common perception, the growth of the health care information organization industry has not been limited to the past decade but has been building slowly over the past 50 years, beginning in the 1940s when growth in the prescription drug market fueled industry interest in understanding and influencing prescribing patterns. The development of this surveillance system was not simply imposed on the medical profession by the pharmaceutical industry but was developed through the interactions of pharmaceutical salesmen, pharmaceutical marketers, academic researchers, individual physicians, and physician organizations. Examination of the role of physicians and physician organizations in the development of prescriber profiling is directly relevant to the contemporary policy debate surrounding this issue.

Twitter Influenza Surveillance: Quantifying Seasonal Misdiagnosis Patterns and their Impact on Surveillance Estimates.

PubMed

Mowery, Jared

2016-01-01

Influenza (flu) surveillance using Twitter data can potentially save lives and increase efficiency by providing governments and healthcare organizations with greater situational awareness. However, research is needed to determine the impact of Twitter users' misdiagnoses on surveillance estimates. This study establishes the importance of Twitter users' misdiagnoses by showing that Twitter flu surveillance in the United States failed during the 2011-2012 flu season, estimates the extent of misdiagnoses, and tests several methods for reducing the adverse effects of misdiagnoses. Metrics representing flu prevalence, seasonal misdiagnosis patterns, diagnosis uncertainty, flu symptoms, and noise were produced using Twitter data in conjunction with OpenSextant for geo-inferencing, and a maximum entropy classifier for identifying tweets related to illness. These metrics were tested for correlations with World Health Organization (WHO) positive specimen counts of flu from 2011 to 2014. Twitter flu surveillance erroneously indicated a typical flu season during 2011-2012, even though the flu season peaked three months late, and erroneously indicated plateaus of flu tweets before the 2012-2013 and 2013-2014 flu seasons. Enhancements based on estimates of misdiagnoses removed the erroneous plateaus and increased the Pearson correlation coefficients by .04 and .23, but failed to correct the 2011-2012 flu season estimate. A rough estimate indicates that approximately 40% of flu tweets reflected misdiagnoses. Further research into factors affecting Twitter users' misdiagnoses, in conjunction with data from additional atypical flu seasons, is needed to enable Twitter flu surveillance systems to produce reliable estimates during atypical flu seasons.

System For Surveillance Of Spectral Signals

DOEpatents

Gross, Kenneth C.; Wegerich, Stephan W.; Criss-Puszkiewicz, Cynthia; Wilks, Alan D.

2004-10-12

A method and system for monitoring at least one of a system, a process and a data source. A method and system have been developed for carrying out surveillance, testing and modification of an ongoing process or other source of data, such as a spectroscopic examination. A signal from the system under surveillance is collected and compared with a reference signal, a frequency domain transformation carried out for the system signal and reference signal, a frequency domain difference function established. The process is then repeated until a full range of data is accumulated over the time domain and a Sequential Probability Ratio Test ("SPRT") methodology applied to determine a three-dimensional surface plot characteristic of the operating state of the system under surveillance.

System For Surveillance Of Spectral Signals

DOEpatents

Gross, Kenneth C.; Wegerich, Stephan; Criss-Puszkiewicz, Cynthia; Wilks, Alan D.

2003-04-22

A method and system for monitoring at least one of a system, a process and a data source. A method and system have been developed for carrying out surveillance, testing and modification of an ongoing process or other source of data, such as a spectroscopic examination. A signal from the system under surveillance is collected and compared with a reference signal, a frequency domain transformation carried out for the system signal and reference signal, a frequency domain difference function established. The process is then repeated until a full range of data is accumulated over the time domain and a Sequential Probability Ratio Test methodology applied to determine a three-dimensional surface plot characteristic of the operating state of the system under surveillance.

System for surveillance of spectral signals

DOEpatents

Gross, Kenneth C.; Wegerich, Stephan W.; Criss-Puszkiewicz, Cynthia; Wilks, Alan D.

2006-02-14

A method and system for monitoring at least one of a system, a process and a data source. A method and system have been developed for carrying out surveillance, testing and modification of an ongoing process or other source of data, such as a spectroscopic examination. A signal from the system under surveillance is collected and compared with a reference signal, a frequency domain transformation carried out for the system signal and reference signal, a frequency domain difference function established. The process is then repeated until a full range of data is accumulated over the time domain and a Sequential Probability Ratio Test ("SPRT") methodology applied to determine a three-dimensional surface plot characteristic of the operating state of the system under surveillance.

System for surveillance of spectral signals

DOEpatents

Gross, Kenneth C.; Wegerich, Stephan W.; Criss-Puszkiewicz, Cynthia; Wilks, Alan D.

2001-01-01

A method and system for monitoring at least one of a system, a process and a data source. A method and system have been developed for carrying out surveillance, testing and modification of an ongoing process or other source of data, such as a spectroscopic examination. A signal from the system under surveillance is collected and compared with a reference signal, a frequency domain transformation carried out for the system signal and reference signal, a frequency domain difference function established. The process is then repeated until a full range of data is accumulated over the time domain and a SPRT sequential probability ratio test methodology applied to determine a three-dimensional surface plot characteristic of the operating state of the system under surveillance.

Development of a State-Wide Competency Test for Marketing Education. Final Report.

ERIC Educational Resources Information Center

Smith, Clifton L.

A project was conducted to develop a valid, competency-referenced test on the core competencies identified for the Missouri Fundamentals of Marketing curriculum. During the project: (1) multiple-choice test items based on the core competencies in the Fundamentals of Marketing curriculum were developed; (2) instructions for onsite administration of…

Self tuning system for industrial surveillance

DOEpatents

Stephan, Wegerich W; Jarman, Kristin K.; Gross, Kenneth C.

2000-01-01

A method and system for automatically establishing operational parameters of a statistical surveillance system. The method and system performs a frequency domain transition on time dependent data, a first Fourier composite is formed, serial correlation is removed, a series of Gaussian whiteness tests are performed along with an autocorrelation test, Fourier coefficients are stored and a second Fourier composite is formed. Pseudorandom noise is added, a Monte Carlo simulation is performed to establish SPRT missed alarm probabilities and tested with a synthesized signal. A false alarm test is then emperically evaluated and if less than a desired target value, then SPRT probabilities are used for performing surveillance.

Improving the postmarket surveillance of total joint arthroplasty devices.

PubMed

Mahomed, Nizar N; Syed, Khalid; Sledge, Clement B; Brennan, Troyen A; Liang, Matthew H

2008-01-01

To evaluate the FDA's approval process and postmarket surveillance strategies for THR devices. The FDA Center for Devices and Radiological Health (CDRH) 510k releasable database was used to document approved THR devices. The CDRH Medical Device Reporting data files were used to study the efficiency of the FDA's post-market surveillance system. Manufacturers were contacted to supply information regarding their implants. Medline was searched between 1966-1996 to determine the percentage of THR devices with published data on clinical outcomes. Between 1976 and 1996, 701 new THR devices were approved by the Substantial Equivalent (SE) route and 34 were approved on the basis of Premarket Approval PMA. The number of approvals doubled between 1991-1995 compared to 1976-1990. Seventy-four different manufacturers obtained approval to market THR devices. Only four manufacturers obtained approval via the PMA application. Under Mandatory Device Reporting all revision arthroplasties should be reported. Using data from 2 independent services for which we had US hospital discharge data in 1993 we estimate that only 3% of all revision THR were reported to the FDA. Manufacturers of hip implants failed to provide useful information. Medline search revealed only 15% of the approved THR devices had published data on outcomes. Current FDA premarket approval and postmarket surveillance strategies fail to provide information for evidence-based selection of THR devices. Recommendations are made to avert problems with device failures.

Evaluation of the Novel Respiratory Virus Surveillance Program: Pediatric Early Warning Sentinel Surveillance (PEWSS)

PubMed Central

Nguyen, Linh M.; Lutman, Michelle L.; Middaugh, John P.

2013-01-01

Objectives Infections caused by respiratory viruses are associated with recurrent epidemics and widespread morbidity and mortality. Routine surveillance of these pathogens is necessary to determine virus activity, monitor for changes in circulating strains, and plan for public health preparedness. The Southern Nevada Health District in Las Vegas, Nevada, recruited five pediatric medical practices to serve as sentinel sites for the Pediatric Early Warning Sentinel Surveillance (PEWSS) program. Methods Sentinel staff collected specimens throughout the year from ill children who met the influenza-like illness case definition and submitted specimens to the Southern Nevada Public Health Laboratory for molecular testing for influenza and six non-influenza viruses. Results Laboratory results were analyzed and reported to the medical and general communities in weekly bulletins year-round. PEWSS data were also used to establish viral respiratory seasonal baselines and in influenza vaccination campaigns. The surveillance program was evaluated using the Centers for Disease Control and Prevention's (CDC's) Updated Guidelines for Evaluating Public Health Surveillance Systems. PEWSS met three of six program usefulness criteria and seven of nine surveillance system attributes, which exceeded the CDC Guidelines evaluation criteria for a useful and complete public health surveillance program. Conclusion We found that PEWSS is a useful and complete public health surveillance system that is simple, flexible, accessible, and stable. PMID:23997308

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

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.

Marketing medical devices in Japan.

PubMed

Ohashi, J

1998-01-01

The control of medical devices in Japan has recently undergone significant changes as the country brings its systems into line with those of the United States and Europe. This article discusses pre-market approval, quality system requirements and post-market surveillance. Many technical issues have been harmonized but language is likely to continue to be a barrier to trade. Details of information services that are available to foreign manufacturers and importers are supplied.

[Surveillance of schistosomiasis in national surveillance sites of Zhenjiang City, 2005-2010].

PubMed

Zhu, Xin-yun; Wu, Rong-feng; Shen, Xue-hui; Li, Ye-fang

2015-12-01

To master the changes of schistosomiasis epidemic situation in national surveillance sites of Zhenjiang City, Jiangsu Province. According to the scheme of the national schistosomiasis surveillance, the Shicheng Village of Yangzhong County and Sanzhou Village of Dantu District were selected as the national schistosomiasis surveillance sites, and from 2005 to 2010, the schistosomiasis morbidity and Oncomelania hupensis status were surveyed and the results were analyzed statistically. In 2010, in the Shicheng Village, the reduction rates of mean living snail density, infected snail density, area with infected snails, and positive blood tests in residents were 98.4%, 0, 0, 71.8% respectively, and in the Sanzhou Village, the reduction rates were 70.4%, 100%, 100% and 81.5%, respectively compared with those in 2005. No acute infections were found in the 2 villages during the period of 6 consecutive years. In the national surveillance sites of Zhenjiang City, the schistosomiasis morbidity has been effectively controlled. However, the areas with snails change little. Therefore, the comprehensive management of snail environment in the marshland should be strengthened in the future.

Ballistic Testing and Product Quality Surveillance for the Interceptor Body Armor - Vest Components Need Improvement

DTIC Science & Technology

2011-01-03

six contracts. Interceptor Body Armor – Vest Components IBA is a modular body armor system that consists of an OTV, ceramic plates , and components...Armor - Vest Components Need Improvement Report Documentation Page Form ApprovedOMB No. 0704-0188 Public reporting burden for the...Ballistic Testing and Product Quality Surveillance for the Interceptor Body Armor - Vest Components Need Improvement 5a. CONTRACT NUMBER 5b. GRANT

Investigating poultry trade patterns to guide avian influenza surveillance and control: a case study in Vietnam

PubMed Central

Fournié, Guillaume; Tripodi, Astrid; Nguyen, Thi Thanh Thuy; Nguyen, Van Trong; Tran, Trong Tung; Bisson, Andrew; Pfeiffer, Dirk U.; Newman, Scott H.

2016-01-01

Live bird markets are often the focus of surveillance activities monitoring avian influenza viruses (AIV) circulating in poultry. However, in order to ensure a high sensitivity of virus detection and effectiveness of management actions, poultry management practices features influencing AIV dynamics need to be accounted for in the design of surveillance programmes. In order to address this knowledge gap, a cross-sectional survey was conducted through interviews with 791 traders in 18 Vietnamese live bird markets. Markets greatly differed according to the sources from which poultry was obtained, and their connections to other markets through the movements of their traders. These features, which could be informed based on indicators that are easy to measure, suggest that markets could be used as sentinels for monitoring virus strains circulating in specific segments of the poultry production sector. AIV spread within markets was modelled. Due to the high turn-over of poultry, viral amplification was likely to be minimal in most of the largest markets. However, due to the large number of birds being introduced each day, and challenges related to cleaning and disinfection, environmental accumulation of viruses at markets may take place, posing a threat to the poultry production sector and to public health. PMID:27405887

Advancing the science for active surveillance: rationale and design for the Observational Medical Outcomes Partnership.

PubMed

Stang, Paul E; Ryan, Patrick B; Racoosin, Judith A; Overhage, J Marc; Hartzema, Abraham G; Reich, Christian; Welebob, Emily; Scarnecchia, Thomas; Woodcock, Janet

2010-11-02

The U.S. Food and Drug Administration (FDA) Amendments Act of 2007 mandated that the FDA develop a system for using automated health care data to identify risks of marketed drugs and other medical products. The Observational Medical Outcomes Partnership is a public-private partnership among the FDA, academia, data owners, and the pharmaceutical industry that is responding to the need to advance the science of active medical product safety surveillance by using existing observational databases. The Observational Medical Outcomes Partnership's transparent, open innovation approach is designed to systematically and empirically study critical governance, data resource, and methodological issues and their interrelationships in establishing a viable national program of active drug safety surveillance by using observational data. This article describes the governance structure, data-access model, methods-testing approach, and technology development of this effort, as well as the work that has been initiated.

Implementation of a Multimodal Mobile System for Point-of-Sale Surveillance: Lessons Learned From Case Studies in Washington, DC, and New York City.

PubMed

Cantrell, Jennifer; Ganz, Ollie; Ilakkuvan, Vinu; Tacelosky, Michael; Kreslake, Jennifer; Moon-Howard, Joyce; Aidala, Angela; Vallone, Donna; Anesetti-Rothermel, Andrew; Kirchner, Thomas R

2015-01-01

In tobacco control and other fields, point-of-sale surveillance of the retail environment is critical for understanding industry marketing of products and informing public health practice. Innovations in mobile technology can improve existing, paper-based surveillance methods, yet few studies describe in detail how to operationalize the use of technology in public health surveillance. The aims of this paper are to share implementation strategies and lessons learned from 2 tobacco, point-of-sale surveillance projects to inform and prepare public health researchers and practitioners to implement new mobile technologies in retail point-of-sale surveillance systems. From 2011 to 2013, 2 point-of-sale surveillance pilot projects were conducted in Washington, DC, and New York, New York, to capture information about the tobacco retail environment and test the feasibility of a multimodal mobile data collection system, which included capabilities for audio or video recording data, electronic photographs, electronic location data, and a centralized back-end server and dashboard. We established a preimplementation field testing process for both projects, which involved a series of rapid and iterative tests to inform decisions and establish protocols around key components of the project. Important components of field testing included choosing a mobile phone that met project criteria, establishing an efficient workflow and accessible user interfaces for each component of the system, training and providing technical support to fieldworkers, and developing processes to integrate data from multiple sources into back-end systems that can be utilized in real-time. A well-planned implementation process is critical for successful use and performance of multimodal mobile surveillance systems. Guidelines for implementation include (1) the need to establish and allow time for an iterative testing framework for resolving technical and logistical challenges; (2) developing a streamlined

Implementation of a Multimodal Mobile System for Point-of-Sale Surveillance: Lessons Learned From Case Studies in Washington, DC, and New York City

PubMed Central

Ganz, Ollie; Ilakkuvan, Vinu; Tacelosky, Michael; Kreslake, Jennifer; Moon-Howard, Joyce; Aidala, Angela; Vallone, Donna; Anesetti-Rothermel, Andrew; Kirchner, Thomas R

2015-01-01

Background In tobacco control and other fields, point-of-sale surveillance of the retail environment is critical for understanding industry marketing of products and informing public health practice. Innovations in mobile technology can improve existing, paper-based surveillance methods, yet few studies describe in detail how to operationalize the use of technology in public health surveillance. Objective The aims of this paper are to share implementation strategies and lessons learned from 2 tobacco, point-of-sale surveillance projects to inform and prepare public health researchers and practitioners to implement new mobile technologies in retail point-of-sale surveillance systems. Methods From 2011 to 2013, 2 point-of-sale surveillance pilot projects were conducted in Washington, DC, and New York, New York, to capture information about the tobacco retail environment and test the feasibility of a multimodal mobile data collection system, which included capabilities for audio or video recording data, electronic photographs, electronic location data, and a centralized back-end server and dashboard. We established a preimplementation field testing process for both projects, which involved a series of rapid and iterative tests to inform decisions and establish protocols around key components of the project. Results Important components of field testing included choosing a mobile phone that met project criteria, establishing an efficient workflow and accessible user interfaces for each component of the system, training and providing technical support to fieldworkers, and developing processes to integrate data from multiple sources into back-end systems that can be utilized in real-time. Conclusions A well-planned implementation process is critical for successful use and performance of multimodal mobile surveillance systems. Guidelines for implementation include (1) the need to establish and allow time for an iterative testing framework for resolving technical and

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

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.

Systems pharmacology augments drug safety surveillance

PubMed Central

Lorberbaum, Tal; Nasir, Mavra; Keiser, Michael J.; Vilar, Santiago; Hripcsak, George; Tatonetti, Nicholas P.

2014-01-01

Small molecule drugs are the foundation of modern medical practice yet their use is limited by the onset of unexpected and severe adverse events (AEs). Regulatory agencies rely on post-marketing surveillance to monitor safety once drugs are approved for clinical use. Despite advances in pharmacovigilance methods that address issues of confounding bias, clinical data of AEs are inherently noisy. Systems pharmacology– the integration of systems biology and chemical genomics – can illuminate drug mechanisms of action. We hypothesize that these data can improve drug safety surveillance by highlighting drugs with a mechanistic connection to the target phenotype (enriching true positives) and filtering those that do not (depleting false positives). We present an algorithm, the modular assembly of drug safety subnetworks (MADSS), to combine systems pharmacology and pharmacovigilance data and significantly improve drug safety monitoring for four clinically relevant adverse drug reactions. PMID:25670520

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.

Emerging Zoonotic Influenza A Virus Detection in Myanmar: Surveillance Practices and Findings.

PubMed

Tun Win, Ye; Gardner, Emma; Hadrill, David; Su Mon, Cho Cho; Kyin, Maung Maung; Maw, Min Thein; Claes, Filip; von Dobschuetz, Sophie; Kalpravidh, Wantanee; Wongsathapornchai, Kachen; Mon, Hla Hla; Myint, Win Win; Thein, Wai Zin; Mon, Pont Pont

We describe 2-season, risk-based, virological surveillance for zoonotic avian influenza in Myanmar and report the first detection of influenza A subtypes H5N6 and H9N2 in Myanmar. The study focused mainly on the live bird markets in border townships, where illegal poultry importation from China usually takes place. The objective was to enhance early warning for low pathogenic avian influenza A(H7N9) incursion. The study followed the guidelines of the Food and Agriculture Organization (FAO) of the United Nations for influenza A(H7N9) surveillance in uninfected countries. The sampling strategy was risk-based at all sampling levels. Sample collection and laboratory analysis were carried out with the government of the Union of the Republic of Myanmar. Laboratory testing was according to a previously published FAO laboratory protocol and algorithm designed to detect a range of influenza A subtypes. Challenges to implementation are outlined. The study provided evidence that the H7N9 subtype had not entered Myanmar but detected other subtypes, including H5N6 and H9N2. Although there were logistical difficulties associated with nation-related issues, the results highlight the importance and feasibility of this risk-based active surveillance, which should be urgently established in other countries, especially those located at the east-southeast influenza epicenter.

Space Situational Awareness using Market Based Agents

NASA Astrophysics Data System (ADS)

Sullivan, C.; Pier, E.; Gregory, S.; Bush, M.

2012-09-01

Space surveillance for the DoD is not limited to the Space Surveillance Network (SSN). Other DoD-owned assets have some existing capabilities for tasking but have no systematic way to work collaboratively with the SSN. These are run by diverse organizations including the Services, other defense and intelligence agencies and national laboratories. Beyond these organizations, academic and commercial entities have systems that possess SSA capability. Most all of these assets have some level of connectivity, security, and potential autonomy. Exploiting them in a mutually beneficial structure could provide a more comprehensive, efficient and cost effective solution for SSA. The collection of all potential assets, providers and consumers of SSA data comprises a market which is functionally illiquid. The development of a dynamic marketplace for SSA data could enable would-be providers the opportunity to sell data to SSA consumers for monetary or incentive based compensation. A well-conceived market architecture could drive down SSA data costs through increased supply and improve efficiency through increased competition. Oceanit will investigate market and market agent architectures, protocols, standards, and incentives toward producing high-volume/low-cost SSA.

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

Health surveillance for occupational respiratory disease.

PubMed

Lewis, L; Fishwick, D

2013-07-01

Occupational lung diseases remain common, and health surveillance is one approach used to assist identification of early cases. To identify areas of good practice within respiratory health surveillance and to formulate recommendations for practice. Published literature was searched since 1990 using a semi-systematic methodology. A total of 561 documents were identified on Medline and Embase combined. Other search engines did not identify relevant documents that had not already been identified by these two main searches. Seventy-nine of these were assessed further and 36 documents were included for the full analysis. Respiratory health surveillance remains a disparate process, even within disease type. A standard validated questionnaire and associated guidance should be developed. Lung function testing was common and generally supported by the evidence. Cross-sectional interpretation of lung function in younger workers needs careful assessment in order to best identify early cases of disease. More informed interpretation of the forced expiratory volume in 1 s/forced vital capacity ratio, for example by using a lower limit of normal for each worker, and of longitudinal lung function information is advised. Immunological tests appear useful in small groups of workers exposed to common occupational allergens. Education, training and improved occupational health policies are likely to improve uptake of health surveillance, to ensure that those who fail health surveillance at any point are handled appropriately.

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.

[Susceptibility surveillance of clinical isolates to fluoroquinolone antimicrobial agents from 2003 to 2008: post-marketing study of prulifloxacin].

PubMed

Kawai, Shin; Yoshida, Atsushi; Okazaki, Mitsuhiro; Tsujihara, Yoshito; Inuzuka, Kazuhisa; Takeuchi, Kazuhide; Yamashita, Naoko; Onodera, Makoto; Hiraishi, Toru; Ida, Takashi; Maebashi, Kazunori

2010-06-01

Yearly changes in the susceptibility of clinical isolates to ulifloxacin (UFX) and other fluoroquinolones were examined through surveys over 3 periods. In the first survey, 534 strains derived from 19 species were collected from clinical specimens during 6 months from December 2003 to May 2004. In the same way, 805 strains were collected from December 2005 to May 2006 in the second survey, and 863 strains were from December 2007 to May 2008 in the third survey. Over these 3 study periods, the susceptibilities of fluoroquinolones against methicillin-susceptible Staphylococcus aureus and Escherichia coli were decreased. The isolation frequency of levofloxacin-nonsusceptible strain was increased from 0% to 11.8% and from 14.6% to 20.8%, respectively. MIC90s of UFX against these pathogens were also increased, but its MIC90 for E. coli was 2 to 4 times lower than that of levofloxacin. On the other hand, the susceptibility of strains of Klebsiella pneumoniae to UFX was increased. Among the fluoroquinolones tested, UFX showed the most potent activity against Pseudomonas aeruginosa, and no changes in the MIC90s occurred during the surveillance. Although one strain of Streptococcus pneumoniae isolated in the third study period showed levofloxacin-resistance (MIC, 8 microg/mL), there were nearly no changes in the MIC90s of any agents tested including UFX against S. pneumoniae during the surveillance. As for other bacterial species, a tendency to increase in resistance to UFX was not observed. The activity of UFX against Salmonella spp. and Shigella spp. was superior/equal to those of fluoroquinolones tested.

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.

Secondary analysis of a marketing research database reveals patterns in dairy product purchases over time.

PubMed

Van Wave, Timothy W; Decker, Michael

2003-04-01

Development of a method using marketing research data to assess food purchase behavior and consequent nutrient availability for purposes of nutrition surveillance, evaluation of intervention effects, and epidemiologic studies of diet-health relationships. Data collected on household food purchases accrued over a 13-week period were selected by using Universal Product Code numbers and household characteristics from a marketing research database. Universal Product Code numbers for 39,408 dairy product purchases were linked to a standard reference for food composition to estimate the nutrient content of foods purchased over time. Two thousand one hundred sixty-one households located in Victoria, Texas, and surrounding communities who were active members of a frequent shopper program. Demographic characteristics of sample households and the nutrient content of their dairy product purchases were analyzed using frequency distribution, cross tabulation, analysis of variance, and t test procedures. A method for using marketing research data was successfully used to estimate household purchases of specific foods and their nutrient content from a marketing database containing hundreds of thousands of records. Distribution of dairy product purchases and their concomitant nutrients between Hispanic and non-Hispanic households were significant (P<.01, P<.001, respectively) and sustained over time. Purchase records from large, nationally representative panels of shoppers, such as those maintained by major market research companies, might be used to accomplish detailed longitudinal epidemiologic studies or surveillance of national food- and nutrient-purchasing patterns within and between countries and segments of their respective populations.

The Development and Pilot Testing of the Marijuana Retail Surveillance Tool (MRST): Assessing Marketing and Point-of-Sale Practices among Recreational Marijuana Retailers

ERIC Educational Resources Information Center

Berg, Carla J.; Henriksen, Lisa; Cavazos-Rehg, Patricia; Schauer, Gillian L.; Freisthler, Bridget

2017-01-01

As recreational marijuana expands, it is critical to develop standardized surveillance measures to study the retail environment. To this end, our research team developed and piloted a tool assessing recreational marijuana retailers in a convenience sample of 20 Denver retailers in 2016. The tool assesses: (i) compliance and security (e.g.…

Post-marketing surveillance system for drugs in pregnancy--15 years experience of ENTIS.

PubMed

Schaefer, Christof; Hannemann, Doreen; Meister, Reinhard

2005-01-01

Teratology Information Services (TIS) provide the public and health professionals with tailor-made information on drug risks in pregnancy. TIS in Europe, Israel and Latin America collaborate in the European Network of Teratology Information Services (ENTIS) in order to optimise interpretation of risk data, risk communication and risk management as well as recommendations for drug treatment in pregnant women. In addition, efforts are undertaken to enhance and harmonise documentation of exposed pregnancies and their outcomes. These prospectively ascertained data are evaluated like controlled, observational cohort studies, where exposed pregnancies are compared to a non-exposed control group for various outcome variables such as (major) malformations, birth measures and the state of the new-born infant, spontaneous abortion. The prospective methodology minimises recall bias of the studied drugs. Evaluating the data collected according to standardised protocols with appropriate statisticals methods substantially improves risk assessment. The comparison of spontaneous abortions between coumarin exposed pregnancies and controls enrolled in the Berlin TIS demonstrates the benefit of the methodology of survival analysis within the framework of the proportional hazard model. The ENTIS multi-centre approach permits studying large exposed cohorts even with seldomly used medicinal products. In terms of post-marketing surveillance there are no alternatives to TIS data. Data collection by TIS uses an already established risk communication system, and has the advantage of low costs and motivated responders. As a TIS is contacted mainly for insufficiently documented drugs or those suspected of acting as developmental toxicants there is even a selection for products needing research.

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.

Safety and Effectiveness of Natalizumab: First Report of Interim Results of Post-Marketing Surveillance in Japan.

PubMed

Saida, Takahiko; Yokoyama, Kazumasa; Sato, Ryusuke; Makioka, Haruki; Iizuka, Yukihiko; Hase, Masakazu; Ling, Yan; Torii, Shinichi

2017-12-01

Natalizumab, a humanized anti-α4 integrin monoclonal antibody, received marketing approval in Japan in 2014 for the treatment of multiple sclerosis (MS). Because the previous large-scale clinical trials of natalizumab were mainly conducted in Europe and North American countries, and data in patients with MS from Japan were limited, we conducted an all-case post-marketing surveillance of natalizumab-treated MS patients from Japan to investigate the safety and effectiveness of natalizumab in a real-world clinical setting in Japan. Here, we report the results of an interim analysis. During the observation period of 2 years, all patients who were treated with natalizumab subsequent to its approval in Japan were followed. The effectiveness of natalizumab was assessed by examining the changes in expanded disability status scale (EDSS) score and annualized relapse rate (ARR) from baseline. Safety was assessed by analyzing the incidence of adverse drug reactions (ADRs). The safety analysis included 106 patients (mean age 39.3 years; women 62.3%) whose data were collected until the data lock point (February 7, 2016). The effectiveness analysis included 75 patients. The majority of patients had relapsing-remitting MS (93/106 patients; 87.7%). The mean length of treatment exposure in the present study was 6.6 months. During the 2-year observation period, no significant change in the EDSS was observed, while the ARR decreased significantly from baseline (72.9% reduction, p = 0.001). ADRs and serious ADRs were observed in 11.3% and 3.8% of patients, respectively; however, no new safety concerns were detected. No patient had progressive multifocal leukoencephalopathy (PML) during the present study period. The safety and effectiveness of natalizumab were confirmed in Japanese patients with MS in clinical practice. Nevertheless, potential risks including PML require continuous, careful observation. Biogen Japan Ltd (Tokyo, Japan).

Surveillance of adverse effects following vaccination and safety of immunization programs.

PubMed

Waldman, Eliseu Alves; Luhm, Karin Regina; Monteiro, Sandra Aparecida Moreira Gomes; Freitas, Fabiana Ramos Martin de

2011-02-01

The aim of the review was to analyze conceptual and operational aspects of systems for surveillance of adverse events following immunization. Articles available in electronic format were included, published between 1985 and 2009, selected from the PubMed/Medline databases using the key words "adverse events following vaccine surveillance", "post-marketing surveillance", "safety vaccine" and "Phase IV clinical trials". Articles focusing on specific adverse events were excluded. The major aspects underlying the Public Health importance of adverse events following vaccination, the instruments aimed at ensuring vaccine safety, and the purpose, attributes, types, data interpretation issues, limitations, and further challenges in adverse events following immunization were describe, as well as strategies to improve sensitivity. The review was concluded by discussing the challenges to be faced in coming years with respect to ensuring the safety and reliability of vaccination programs.

Participant-centred active surveillance of adverse events following immunisation: a narrative review

PubMed Central

Cashman, Patrick; Macartney, Kristine; Khandaker, Gulam; King, Catherine; Gold, Michael; Durrheim, David N.

2017-01-01

Abstract The importance of active, participant-centred monitoring of adverse events following immunisation (AEFI) is increasingly recognised as a valuable adjunct to traditional passive AEFI surveillance. The databases OVID Medline and OVID Embase were searched to identify all published articles referring to AEFI. Only studies which sought participant response after vaccination were included. A total of 6060 articles published since the year 2000 were identified. After the application of screening inclusion and exclusion criteria, 25 articles describing 23 post-marketing AEFI systems were identified. Most countries had a single system: Ghana, Japan, China, Korea, Netherlands, Singapore, Brazil, Cambodia, Sri Lanka, Turkey and Cameroon except the USA (2), Canada (4) and Australia (6). Data were collected from participants with and without AEFI in all studies reviewed with denominator data enabling AEFI rate calculations. All studies considered either a single vaccine or specified vaccines or were time limited except one Australian system, which provides continuous automated participant-centred active surveillance of all vaccines. Post-marketing surveillance systems using solicited patient feedback are emerging as a novel AEFI monitoring tool. A number of exploratory systems utilising e-technology have been developed and their potential for scaling up and application in low and middle income countries deserves further investigation. PMID:28582563

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.

Companion animal disease surveillance: a new solution to an old problem?

PubMed

Ward, M P; Kelman, M

2011-09-01

Infectious disease surveillance in companion animals has a long history. However, it has mostly taken the form of ad hoc surveys, or has focused on adverse reactions to pharmaceuticals. In 2006 a Blue Ribbon Panel was convened by the U.S. White House Office of Science and Technology Policy to discuss the potential utility of a national companion animal health surveillance system. Such a system could provide fundamental information about disease occurrence, transmission and risk factors; and could facilitate industry-supported pharmaco-epidemiological studies and post-market surveillance. Disease WatchDog, a prospective national disease surveillance project, was officially launched in January 2010 to capture data on diseases in dogs and cats throughout Australia. Participation is encouraged by providing registrants real-time disease maps and material for improved communication between veterinarians and clients. From January to mid-November 2010, an estimated 31% of veterinary clinics Australia-wide joined the project. Over 1300 disease cases - including Canine Parvovirus (CPV), Canine Distemper, Canine Hepatitis, Feline Calicivirus, Feline Herpesvirus, and Tick Paralysis - were reported. In New South Wales alone, 552 CPV cases in dogs were reported from 89 postcode locations. New South Wales data was scanned using the space-time permutation test. Up to 24 clusters (P<0.01) were identified, occurring in all months except March. The greatest number of clusters (n=6) were identified in April. The most likely cluster was identified in western Sydney, where 36 cases of CPV were reported from a postcode in February. Although the project is still in its infancy, already new information on disease distribution has been produced. Disease information generated could facilitate targeted control and prevention programs. Copyright © 2011 Elsevier Ltd. All rights reserved.

Expanding poliomyelitis and measles surveillance networks to establish surveillance for acute meningitis and encephalitis syndromes--Bangladesh, China, and India, 2006-2008.

PubMed

2012-12-14

Quality surveillance is critical to the control and elimination of vaccine-preventable diseases (VPDs). A key strategy for enhancing VPD surveillance, outlined in the World Health Organization (WHO) Global Framework for Immunization Monitoring and Surveillance (GFIMS), is to expand and link existing VPD surveillance systems (particularly those developed for polio eradication and measles elimination) to include other priority VPDs. Since the launch of the Global Polio Eradication Initiative in 1988, the incidence of polio has decrease by 99% worldwide. A cornerstone of this success is a sensitive surveillance system based on the rapid and timely reporting of all acute flaccid paralysis (AFP) cases in children aged <15 years, with confirmatory diagnostic testing performed by laboratories that are part of a global network. As countries achieve polio-free status, many have expanded syndromic surveillance to include persons with rash and fever, and have built measles diagnostic capacity in existing polio reference laboratories. Acute meningitis/encephalitis syndrome (AMES) and acute encephalitis syndrome (AES) are candidates for expanded surveillance because they are most often caused by VPDs of public health importance for which confirmatory laboratory tests exist. Vaccine-preventable cases of encephalitis include approximately 68,000 Japanese encephalitis (JE) cases, resulting in 13,000-20,000 deaths each year in Asia. Moreover, although bacterial meningitis incidence in Asia is not as well-documented, pneumococcal and meningococcal meningitis outbreaks have been reported in Bangladesh and China, and the incidence of Haemophilus influenzae type b (Hib) meningitis in children aged <5 years in India has been estimated to be 7.1 per 100,000 population, similar to that in European countries before the introduction of vaccine. This report describes a prototype for expanding existing polio and measles surveillance networks in Bangladesh, China, and India to include

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

PubMed

Matheny, Michael E; Normand, Sharon-Lise T; Gross, Thomas P; Marinac-Dabic, Danica; Loyo-Berrios, Nilsa; Vidi, Venkatesan D; Donnelly, Sharon; Resnic, Frederic S

2011-12-14

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. 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. 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). 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.

Postmarketing Surveillance for “Modified-Risk” Tobacco Products

PubMed Central

2012-01-01

Introduction: The U.S. Food and Drug Administration (FDA) acquired authority to regulate tobacco products in 2009. This authority will provide a structured process for manufacturers to introduce products that may have “modified-risk” for morbidity or mortality relative to traditional tobacco products, with postmarketing surveillance and studies a condition of marketing. Method: A narrative review approach was taken. The author searched and integrated publicly accessible literature on tobacco product surveillance as well as drug and medical device postmarket activities currently performed by FDA. Results: FDA relies on active and passive methods for postmarket surveillance and can require specific studies and risk evaluation and mitigation strategies for certain products, including those with abuse liability. Past efforts at examining the individual and population effects of reduced harm tobacco products provide an example of integrating different data streams. Discussion: Postmarket surveillance can be viewed in terms of the Agent–Host–Vector–Environment model, and concepts from diffusion of innovations are relevant to understanding factors associated with the adoption of new products by the population. Given that active and passive surveillance approaches have different strengths and weaknesses, multiple approaches may be necessary to evaluate population-level effects. Assuring that required studies are properly conducted and reported and that data indicating significant public health harms are quickly recognized will be important going forward. Conclusions: The advent of broad regulatory authority over tobacco provides opportunities for policy evaluation research. The research community can provide FDA with the independent science it needs to evaluate the public health impact of novel tobacco products. PMID:21330282

Malaria surveillance in the Democratic Republic of the Congo: comparison of microscopy, PCR, and rapid diagnostic test.

PubMed

Doctor, Stephanie M; Liu, Yunhao; Whitesell, Amy; Thwai, Kyaw L; Taylor, Steve M; Janko, Mark; Emch, Michael; Kashamuka, Melchior; Muwonga, Jérémie; Tshefu, Antoinette; Meshnick, Steven R

2016-05-01

Malaria surveillance is critical for control efforts, but diagnostic methods frequently disagree. Here, we compare microscopy, PCR, and a rapid diagnostic test in 7137 samples from children in the Democratic Republic of the Congo using latent class analysis. PCR had the highest sensitivity (94.6%) and microscopy had the lowest (76.7%). Copyright © 2016 Elsevier Inc. All rights reserved.

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. Copyright �

Pertussis surveillance and control: exploring variations and delays in testing, laboratory diagnostics and public health service notifications, the Netherlands, 2010 to 2013

PubMed Central

Heil, Jeanne; ter Waarbeek, Henriëtte L G; Hoebe, Christian J P A; Jacobs, Peter H A; van Dam, Dirk W; Trienekens, Thera A M; Cals, Jochen W L; van Loo, Inge H M; Dukers-Muijrers, Nicole H T M

2017-01-01

Pertussis is most severe among unvaccinated infants (< 1 year of age), and still leads to several reported deaths in the Netherlands every year. In order to avoid pertussis-related infant morbidity and mortality, pertussis surveillance data are used to guide pertussis control measures. However, more insight into the accuracy of pertussis surveillance and control, and into the range of healthcare and public health-related factors that impede this are needed. We analysed a unique combination of data sources from one Dutch region of 1.1 million residents, including data from laboratory databases and local public health notifications between 2010 and 2013. This large study (n = 12,090 pertussis tests) reveals possible misdiagnoses, substantial under-notification (18%, 412/2,301 laboratory positive episodes) and a delay between patient symptoms and notification to the local public health services (median 34 days, interquartile range (IQR): 27–54). It is likely that the misdiagnoses, under-notification and overall delay in surveillance data are not unique to this area of the Netherlands, and are generalisable to other countries in Europe. In addition to preventive measures such as maternal immunisation, based on current findings, we further recommend greater adherence to testing guidelines, standardisation of test interpretation guidelines, use of automatic notification systems and earlier preventive measures. PMID:28749331

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.

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.

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

2017-10-01

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.

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

PubMed Central

Dieye, Yakou; 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

2017-01-01

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. PMID:28972982

Responsibilities of regulatory agencies in the marketing of antimicrobials.

PubMed

Grein, K

2012-04-01

The regulatory agencies' main responsibility regarding the marketing of veterinary medicinal products is to ensure that the products have a marketing authorisation with specific conditions of use adequate to ensure the quality, safety and efficacy of the product under consideration. In addition, control and surveillance systems are necessary to allow monitoring of the product after it has been authorised. In respectto antimicrobials, specific consideration must be given to minimising resistance development and retaining the effectiveness of these drugs for the treatment of humans and animals. Surveillance programmes should be in place to follow trends in resistance development, as well as in the consumption of veterinary antimicrobials, in order to provide for science-based policy recommendations regarding public and animal health.

Identifying newly acquired cases of hepatitis C using surveillance: a literature review.

PubMed

Sacks-Davis, R; VAN Gemert, C; Bergeri, I; Stoove, M; Hellard, M

2012-11-01

Surveillance of newly acquired hepatitis C virus (HCV) infection is crucial for understanding the epidemiology of HCV and informing public health practice. However, monitoring such infections via surveillance systems is challenging because they are commonly asymptomatic. A literature review was conducted to identify methodologies used by HCV surveillance systems to identify newly acquired infections; relevant surveillance systems in 15 countries were identified. Surveillance systems used three main strategies to identify newly acquired infections: (1) asking physicians to classify cases; (2) identifying symptomatic cases or cases with elevated alanine aminotransferases; and (3) identifying cases with documented evidence of anti-HCV antibody seroconversion within a specific time-frame. Case-ascertainment methods varied with greater completeness of data in enhanced compared to passive surveillance systems. Automated systems that extract and link testing data from multiple laboratory and clinic databases may provide an opportunity for collecting testing histories for individuals that is less resource intensive than enhanced surveillance.

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.

Evaluation of routine depopulation, cleaning, and disinfection procedures in the live bird markets, New York.

PubMed

Trock, Susan C; Gaeta, Michelle; Gonzalez, Annette; Pederson, Janice C; Senne, Dennis A

2008-03-01

During the past years surveillance for avian influenza has been conducted in the live bird markets (LBMs) in New York as well as other states along the east coast. Repeated attempts to eradicate H5 and H7 influenza from the New York markets have focused efforts on the LBMs themselves. Despite repeated mandatory market closures accompanied by cleaning and disinfecting (C/D) procedures, avian influenza virus continued to be isolated. In an effort to assess the adequacy of the C/D procedure, samples were collected in temporal proximity to the depopulation and C/D. Comparison of the pre-C/D (83% virus positive), at C/D approval (1.6% positive) and post-C/D testing (33% positive) indicate that the current procedures of C/D can be effective at eliminating these influenza viruses. However, reinfection via introduction of influenza-virus-positive birds can occur shortly after the market reopens.

Live Bird Markets of Bangladesh: H9N2 Viruses and the Near Absence of Highly Pathogenic H5N1 Influenza

PubMed Central

Negovetich, Nicholas J.; Feeroz, Mohammed M.; Jones-Engel, Lisa; Walker, David; Alam, S. M. Rabiul; Hasan, Kamrul; Seiler, Patrick; Ferguson, Angie; Friedman, Kim; Barman, Subrata; Franks, John; Turner, Jasmine; Krauss, Scott; Webby, Richard J.; Webster, Robert G.

2011-01-01

Avian influenza surveillance in Bangladesh has been passive, relying on poultry farmers to report suspected outbreaks of highly pathogenic H5N1 influenza. Here, the results of an active surveillance effort focusing on the live-bird markets are presented. Prevalence of influenza infection in the birds of the live bird markets is 23.0%, which is similar to that in poultry markets in other countries. Nearly all of the isolates (94%) were of the non-pathogenic H9N2 subtype, but viruses of the H1N2, H1N3, H3N6, H4N2, H5N1, and H10N7 subtypes were also observed. The highly pathogenic H5N1-subtype virus was observed at extremely low prevalence in the surveillance samples (0.08%), and we suggest that the current risk of infection for humans in the retail poultry markets in Bangladesh is negligible. However, the high prevalence of the H9 subtype and its potential for interaction with the highly pathogenic H5N1-subtype, i.e., reassortment and attenuation of host morbidity, highlight the importance of active surveillance of the poultry markets. PMID:21541296

Infectious Disease Surveillance in the Big Data Era: Towards Faster and Locally Relevant Systems

PubMed Central

Simonsen, Lone; Gog, Julia R.; Olson, Don; Viboud, Cécile

2016-01-01

While big data have proven immensely useful in fields such as marketing and earth sciences, public health is still relying on more traditional surveillance systems and awaiting the fruits of a big data revolution. A new generation of big data surveillance systems is needed to achieve rapid, flexible, and local tracking of infectious diseases, especially for emerging pathogens. In this opinion piece, we reflect on the long and distinguished history of disease surveillance and discuss recent developments related to use of big data. We start with a brief review of traditional systems relying on clinical and laboratory reports. We then examine how large-volume medical claims data can, with great spatiotemporal resolution, help elucidate local disease patterns. Finally, we review efforts to develop surveillance systems based on digital and social data streams, including the recent rise and fall of Google Flu Trends. We conclude by advocating for increased use of hybrid systems combining information from traditional surveillance and big data sources, which seems the most promising option moving forward. Throughout the article, we use influenza as an exemplar of an emerging and reemerging infection which has traditionally been considered a model system for surveillance and modeling. PMID:28830112

75 FR 81512 - Airworthiness Directives; Various Aviation Communication & Surveillance Systems (ACSS) Traffic...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-28

... Communication & Surveillance Systems (ACSS) Traffic Alert and Collision Avoidance System (TCAS) Units AGENCY... & Surveillance Systems (ACSS) Traffic Alert and Collision Avoidance System (TCAS) units during a flight test over... applies to Aviation Communication & Surveillance Systems (ACSS) Traffic Alert and Collision Avoidance...

Final report : mobile surveillance and wireless communication systems field operational test. Volume 2, FOT objectives, organization, system design, results, conclusions, and recommendations

DOT National Transportation Integrated Search

1999-03-01

The Mobile Surveillance and Wireless Communication Systems Field Operational Test (FOT) evaluated the performance of wireless traffic detection and communications systems in areas where permanent detectors, electrical power, and landline communicatio...

Using mobile phone text messaging for malaria surveillance in rural Kenya

PubMed Central

2014-01-01

Background Effective surveillance systems are required to track malaria testing and treatment practices. A 26-week study “SMS for Life” was piloted in five rural districts of Kenya to examine whether SMS reported surveillance data could ensure real-time visibility of accurate data and their use by district managers to impact on malaria case-management. Methods Health workers from 87 public health facilities used their personal mobile phones to send a weekly structured SMS text message reporting the counts of four basic surveillance data elements to a web-based system accessed by district managers. Longitudinal monitoring of SMS reported data through the web-based system and two rounds of cross-sectional health facility surveys were done to validate accuracy of data. Results Mean response rates were 96% with 87% of facilities reporting on time. Fifty-eight per cent of surveillance data parameters were accurately reported. Overall mean testing rates were 37% with minor weekly variations ranging from 32 to 45%. Overall test positivity rate was 24% (weekly range: 17-37%). Ratio of anti-malarial treatments to test positive cases was 1.7:1 (weekly range: 1.3:1–2.2:1). District specific trends showed fluctuating patterns in testing rates without notable improvement over time but the ratio of anti-malarial treatments to test positive cases improved over short periods of time in three out of five districts. Conclusions The study demonstrated the feasibility of using simple mobile phone text messages to transmit timely surveillance data from peripheral health facilities to higher levels. However, accuracy of data reported was suboptimal. Future work should focus on improving quality of SMS reported surveillance data. PMID:24642130

Multicenter, noninterventional, post-marketing surveillance study to evaluate dosing of recombinant human follicle-stimulating hormone using the redesigned follitropin alfa pen in women undergoing ovulation induction.

PubMed

Nawroth, Frank; Tandler-Schneider, Andreas; Bilger, Wilma

2015-01-01

This prospective, noninterventional, post-marketing surveillance study evaluated doses of recombinant human follicle-stimulating hormone (r-hFSH) using the redesigned follitropin alfa pen in women who were anovulatory or oligomenorrheic and undergoing ovulation induction (OI) alone or OI with intrauterine insemination. The primary endpoint was the proportion of patients who achieved monofollicular or bifollicular development (defined as one or two follicles ≥15 mm). Secondary endpoints included characteristics of ovulation stimulation treatment, such as mean total and mean daily r-hFSH doses. Data were analyzed for 3,193 patients from 30 German fertility centers. The proportion of patients with monofollicular or bifollicular development was 71.1% (n=2,270 of a total of 3,193 patients; intent-to-treat population). The mean±standard deviation total and daily doses of r-hFSH were 696.9±542.5 IU and 61.7±29.4 IU, respectively. The three doses prescribed most frequently were: 37.5 IU (n=703 from N=3,189; 22.0%), 50.0 IU (n=1,056 from N=3,189; 33.1%), and 75.0 IU (n=738 from N=3,189; 23.1%) on the first day of stimulation; and 37.5 IU (n=465 from N=3,189; 14.6%), 50.0 IU (n=922 from N=3,189; 28.9%), and 75.0 IU (n=895 from N=3,189; 28.1%) on the last day of stimulation. This noninterventional, post-marketing surveillance study found that monofollicular or bifollicular development was achieved in 71% of patients studied and the small dose increment (12.5 IU) of the redesigned follitropin alfa pen allowed individualized treatment of women undergoing OI.

A Space Surveillance Ontology: Captured in an XML Schema

DTIC Science & Technology

2000-10-01

characterization in a way most appropriate to a sub- domain. 6. The commercial market is embracing XML, and the military can take advantage of this significant...the space surveillance ontology effort to two key efforts: the Defense Information Infrastructure Common Operating Environment (DII COE) XML...strongly believe XML schemas will supplant them. Some of the advantages that XML schemas provide over DTDs include: • Strong data typing: The XML Schema

Converting Mosquito Surveillance to Arbovirus Surveillance with Honey-Baited Nucleic Acid Preservation Cards.

PubMed

Flies, Emily J; Toi, Cheryl; Weinstein, Philip; Doggett, Stephen L; Williams, Craig R

2015-07-01

Spatially and temporally accurate information about infectious mosquito distribution allows for pre-emptive public health interventions that can reduce the burden of mosquito-borne infections on human populations. However, the labile nature of arboviruses, the low prevalence of infection in mosquitoes, the expensive labor costs for mosquito identification and sorting, and the specialized equipment required for arbovirus testing can obstruct arbovirus surveillance efforts. The recently developed techniques of testing mosquito expectorate using honey-baited nucleic acid preservation cards or sugar bait stations allows a sensitive method of testing for infectious, rather than infected, mosquito vectors. Here we report the results from the first large-scale incorporation of honey-baited cards into an existing mosquito surveillance program. During 4 months of the peak virus season (January-April, 2014) for a total of 577 trap nights, we set CO2-baited encephalitis vector survey (EVS) light traps at 88 locations in South Australia. The collection container for the EVS trap was modified to allow for the placement of a honey-baited nucleic acid preservation card (FTA™ card) inside. After collection, mosquitoes were maintained in a humid environment and allowed access to the cards for 1 week. Cards were then analyzed for common endemic Australian arboviruses using a nested RT-PCR. Eighteen virus detections, including 11 Ross River virus, four Barmah Forest virus, and three Stratford virus (not previously reported from South Australia) were obtained. Our findings suggest that adding FTA cards to an existing mosquito surveillance program is a rapid and efficient way of detecting infectious mosquitoes with high spatial resolution.

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.

Surveillance of working conditions and the work environment: development of a national hazard surveillance tool in New Zealand.

PubMed

Lilley, Rebbecca; Feyer, Anne-Marie; Firth, Hilda; Cunningham, Chris; Paul, Charlotte

2010-02-01

Changes to work and the impact of these changes on worker health and safety have been significant. A core surveillance data set is needed to understand the impact of working conditions and work environments. Yet, there is little harmony amongst international surveys and a critical lack of guidance identifying the best directions for surveillance efforts. This paper describes the establishment of an instrument suitable for use as a hazard surveillance tool for New Zealand workers. An iterative process of critical review was undertaken to create a dimensional framework and select specific measures from existing instruments. Pilot testing to ascertain participant acceptability of the questions was undertaken. The final questionnaire includes measures of socio-demographic characteristics, occupational history, work organisation, physicochemical, ergonomic and psychosocial hazards. Outcome measures were also included. A robust New Zealand hazard surveillance questionnaire comprehensively covering the key measures of work organisation and work environments that impact upon worker health and safety outcomes was developed. Recommended measures of work organisation, work environment and health outcomes that should be captured in work environment surveillance are made.

Final report : mobile surveillance and wireless communication systems field operational test. Volume 1, Executive summary

DOT National Transportation Integrated Search

1999-03-01

This study focused on assessing the application of traffic monitoring and management systems which use transportable surveillance and ramp meter trailers, video image processors, and wireless communications. The mobile surveillance and wireless commu...

Participant-centred active surveillance of adverse events following immunisation: a narrative review.

PubMed

Cashman, Patrick; Macartney, Kristine; Khandaker, Gulam; King, Catherine; Gold, Michael; Durrheim, David N

2017-05-01

The importance of active, participant-centred monitoring of adverse events following immunisation (AEFI) is increasingly recognised as a valuable adjunct to traditional passive AEFI surveillance. The databases OVID Medline and OVID Embase were searched to identify all published articles referring to AEFI. Only studies which sought participant response after vaccination were included. A total of 6060 articles published since the year 2000 were identified. After the application of screening inclusion and exclusion criteria, 25 articles describing 23 post-marketing AEFI systems were identified. Most countries had a single system: Ghana, Japan, China, Korea, Netherlands, Singapore, Brazil, Cambodia, Sri Lanka, Turkey and Cameroon except the USA (2), Canada (4) and Australia (6). Data were collected from participants with and without AEFI in all studies reviewed with denominator data enabling AEFI rate calculations. All studies considered either a single vaccine or specified vaccines or were time limited except one Australian system, which provides continuous automated participant-centred active surveillance of all vaccines. Post-marketing surveillance systems using solicited patient feedback are emerging as a novel AEFI monitoring tool. A number of exploratory systems utilising e-technology have been developed and their potential for scaling up and application in low and middle income countries deserves further investigation. © The Author 2017. Published by Oxford University Press on behalf of Royal Society of Tropical Medicine and Hygiene.

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.

Surveillance of avian influenza in the Caribbean through the Caribbean Animal Health Network: surveillance tools and epidemiologic studies.

PubMed

Lefrançois, T; Hendrikx, P; Ehrhardt, N; Millien, M; Gomez, L; Gouyet, L; Gaidet, N; Gerbier, G; Vachiéry, N; Petitclerc, F; Carasco-Lacombe, C; Pinarello, V; Ahoussou, S; Levesque, A; Gongora, H V; Trotman, M

2010-03-01

The Caribbean region is considered to be at risk for avian influenza (AI) due to a large backyard poultry system, an important commercial poultry production system, the presence of migratory birds, and disparities in the surveillance systems. The Caribbean Animal Health Network (CaribVET) has developed tools to implement AI surveillance in the region with the goals to have 1) a regionally harmonized surveillance protocol and specific web pages for AI surveillance on www.caribvet.net, and 2) an active and passive surveillance for AI in domestic and wild birds. A diagnostic network for the Caribbean, including technology transfer and AI virus molecular diagnostic capability in Guadeloupe (real-time reverse transcription-polymerase chain reaction for the AI virus matrix gene), was developed. Between 2006 and 2009, 627 samples from four Caribbean countries were tested for three circumstances: importation purposes, following a clinical suspicion of AI, or through an active survey of wild birds (mainly waders) during the southward and northward migration periods in Guadeloupe. None of the samples tested were positive, suggesting a limited role of these species in the AI virus ecology in the Caribbean. Following low pathogenic H5N2 outbreaks in the Dominican Republic in 2007, a questionnaire was developed to collect data for a risk analysis of AI spread in the region through fighting cocks. The infection pathway of the Martinique commercial poultry sector by AI, through introduction of infected cocks, was designed, and recommendations were provided to the Caribbean Veterinary Services to improve cock movement control and biosecurity measures. The CaribVET and its organization allowed interaction between diagnostic and surveillance tools on the one hand and epidemiologic studies on the other, both of them developed in congruence with regional strategies. Together, these CaribVET activities contribute to strengthening surveillance of avian influenza virus (AIV) in the

A Post-marketing Surveillance Study of Chronic Wounds Treated With a Native Collagen Calcium Alginate Dressing.

PubMed

Sabo, Matthew; Le, Lam; Yaakov, Raphael A; Carter, Marissa; Serena, Thomas E

2018-04-01

Chronic wounds (ie, wounds that fail to progress through a normal, orderly, timely sequence of repair) continue to pose significant clinical and economic burdens. A prospective, descriptive, 3-week post-marketing surveillance study was conducted across 3 wound care centers in the United States to evaluate the effectiveness of a collagen calcium alginate dressing on chronic wounds in conjunction with standard care (SC) practices (eg, offloading, debridement, compression) to support healing. Eligible participants had to be >18 years of age, have at least 1 chronic wound, and no known sensitivity to collagen. Demographic characteristics were recorded at the screening visit on case report forms. At each visit, wound-related pain was assessed using the Visual Analog Scale along with wound characteristics including size (using digital planimetry), wound exudate (minimal, moderate, heavy), and odor (none, mild). Participants were monitored for adverse events as well as infection based on signs and symptoms in and around the local wound bed, the deeper structures, and the surrounding skin. An intention-to-treat approach was used for all analyses. If an observation was missing, the last observation carried forward principle was used. For wounds that healed, pain and exudate were set to 0 (no pain/exudate) at visit 4. Descriptive, paired t tests and the Wilcoxon signed rank test were used to analyze the data. Of the 31 participants (15 men, 16 women, mean age 66.6 years), most (13, 42%) had a diabetic foot ulcer or venous leg ulcer (10, 32%); median duration of all wounds was 148 days. Thirty (30) patients completed the study. The mean number of comorbidities was 10.6 ± 6.3, and patients used a mean of 9.3 ± 5.64 prescription or over-the-counter medications. For all wounds combined, mean wound area was 4.8 ± 8.38 cm2 at baseline. At week 3, a decrease in wound area of 38.1% was noted (median: 45% ± 42.54; P = .006); 3 wounds healed completely. The change in wound exudate

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.

Student Drug Testing and the Surveillance School Economy: An Analysis of Media Representation and Policy Transfer in Australian Schools

ERIC Educational Resources Information Center

Taylor, Emmeline

2018-01-01

Anxieties relating to the health, safety and security of schoolchildren have been met with a variety of surveillance apparatus in schools internationally. Drawing on findings from a content analysis of newspaper reports relating to drug testing in Australian schools, this article seeks to excavate the ways in which the media shapes, informs,…

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…

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…

Live Animal Markets in Minnesota: A Potential Source for Emergence of Novel Influenza A Viruses and Interspecies Transmission

PubMed Central

Choi, Mary J.; Torremorell, Montserrat; Bender, Jeff B.; Smith, Kirk; Boxrud, David; Ertl, Jon R.; Yang, My; Suwannakarn, Kamol; Her, Duachi; Nguyen, Jennifer; Uyeki, Timothy M.; Levine, Min; Lindstrom, Stephen; Katz, Jacqueline M.; Jhung, Michael; Vetter, Sara; Wong, Karen K.; Sreevatsan, Srinand; Lynfield, Ruth

2015-01-01

Background. Live animal markets have been implicated in transmission of influenza A viruses (IAVs) from animals to people. We sought to characterize IAVs at 2 live animal markets in Minnesota to assess potential routes of occupational exposure and risk for interspecies transmission. Methods. We implemented surveillance for IAVs among employees, swine, and environment (air and surfaces) during a 12-week period (October 2012–January 2013) at 2 markets epidemiologically associated with persons with swine-origin IAV (variant) infections. Real-time reverse transcription polymerase chain reaction (rRT-PCR), viral culture, and whole-genome sequencing were performed on respiratory and environmental specimens, and serology on sera from employees at beginning and end of surveillance. Results. Nasal swabs from 11 of 17 (65%) employees tested positive for IAVs by rRT-PCR; 7 employees tested positive on multiple occasions and 1 employee reported influenza-like illness. Eleven of 15 (73%) employees had baseline hemagglutination inhibition antibody titers ≥40 to swine-origin IAVs, but only 1 demonstrated a 4-fold titer increase to both swine-origin and pandemic A/Mexico/4108/2009 IAVs. IAVs were isolated from swine (72/84), air (30/45), and pen railings (5/21). Whole-genome sequencing of 122 IAVs isolated from swine and environmental specimens revealed multiple strains and subtype codetections. Multiple gene segment exchanges among and within subtypes were observed, resulting in new genetic constellations and reassortant viruses. Genetic sequence similarities of 99%–100% among IAVs of 1 market customer and swine indicated interspecies transmission. Conclusions. At markets where swine and persons are in close contact, swine-origin IAVs are prevalent and potentially provide conditions for novel IAV emergence. PMID:26223994

Live Animal Markets in Minnesota: A Potential Source for Emergence of Novel Influenza A Viruses and Interspecies Transmission.

PubMed

Choi, Mary J; Torremorell, Montserrat; Bender, Jeff B; Smith, Kirk; Boxrud, David; Ertl, Jon R; Yang, My; Suwannakarn, Kamol; Her, Duachi; Nguyen, Jennifer; Uyeki, Timothy M; Levine, Min; Lindstrom, Stephen; Katz, Jacqueline M; Jhung, Michael; Vetter, Sara; Wong, Karen K; Sreevatsan, Srinand; Lynfield, Ruth

2015-11-01

Live animal markets have been implicated in transmission of influenza A viruses (IAVs) from animals to people. We sought to characterize IAVs at 2 live animal markets in Minnesota to assess potential routes of occupational exposure and risk for interspecies transmission. We implemented surveillance for IAVs among employees, swine, and environment (air and surfaces) during a 12-week period (October 2012-January 2013) at 2 markets epidemiologically associated with persons with swine-origin IAV (variant) infections. Real-time reverse transcription polymerase chain reaction (rRT-PCR), viral culture, and whole-genome sequencing were performed on respiratory and environmental specimens, and serology on sera from employees at beginning and end of surveillance. Nasal swabs from 11 of 17 (65%) employees tested positive for IAVs by rRT-PCR; 7 employees tested positive on multiple occasions and 1 employee reported influenza-like illness. Eleven of 15 (73%) employees had baseline hemagglutination inhibition antibody titers ≥40 to swine-origin IAVs, but only 1 demonstrated a 4-fold titer increase to both swine-origin and pandemic A/Mexico/4108/2009 IAVs. IAVs were isolated from swine (72/84), air (30/45), and pen railings (5/21). Whole-genome sequencing of 122 IAVs isolated from swine and environmental specimens revealed multiple strains and subtype codetections. Multiple gene segment exchanges among and within subtypes were observed, resulting in new genetic constellations and reassortant viruses. Genetic sequence similarities of 99%-100% among IAVs of 1 market customer and swine indicated interspecies transmission. At markets where swine and persons are in close contact, swine-origin IAVs are prevalent and potentially provide conditions for novel IAV emergence. © The Author 2015. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Mapping of the US Domestic Influenza Virologic Surveillance Landscape.

PubMed

Jester, Barbara; Schwerzmann, Joy; Mustaquim, Desiree; Aden, Tricia; Brammer, Lynnette; Humes, Rosemary; Shult, Pete; Shahangian, Shahram; Gubareva, Larisa; Xu, Xiyan; Miller, Joseph; Jernigan, Daniel

2018-07-17

Influenza virologic surveillance is critical each season for tracking influenza circulation, following trends in antiviral drug resistance, detecting novel influenza infections in humans, and selecting viruses for use in annual seasonal vaccine production. We developed a framework and process map for characterizing the landscape of US influenza virologic surveillance into 5 tiers of influenza testing: outpatient settings (tier 1), inpatient settings and commercial laboratories (tier 2), state public health laboratories (tier 3), National Influenza Reference Center laboratories (tier 4), and Centers for Disease Control and Prevention laboratories (tier 5). During the 2015-16 season, the numbers of influenza tests directly contributing to virologic surveillance were 804,000 in tiers 1 and 2; 78,000 in tier 3; 2,800 in tier 4; and 3,400 in tier 5. With the release of the 2017 US Pandemic Influenza Plan, the proposed framework will support public health officials in modeling, surveillance, and pandemic planning and response.

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.

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.

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.

A mortality index for postmarketing surveillance of new medications.

PubMed

Rose, J C; Unis, A S

2000-03-01

The rate of introduction of new pharmaceuticals is growing as a result of advances in molecular pharmacology and targeted drug development. The Fatal Toxicity Index (FTI) has been proposed as a means for monitoring drug toxicity through post-marketing surveillance. The FTI requires data regarding the general availability of a particular agent in the community which, in the US, is proprietary. The authors propose a Mortality Index as an alternative method for calculating relative lethality that does not rely on proprietary information for postmarketing surveillance. Using data from the Toxic Exposure Surveillance System (TESS) a Mortality Index was calculated from the proportion of deaths occurring among all patients who present to a health care facility with an overdose on the same agent or class of agents. The average Mortality Index for various drugs or drug classes for the years 1989 to 1997 is reported. Because the Mortality Index for desipramine appeared much greater than that for the other tricyclics, a chi-squared analysis was performed. The authors conclude, based on this analysis, that desipramine is significantly more likely to lead to death after overdosage than any other tricyclic antidepressant in the study. Also, the Mortality Index appeared to identify the impact of pediatric formulations on overdose lethality. We conclude that the Mortality Index may be a useful tool for determining the safety of agents during the postmarketing surveillance phase.

BACTrack: A Surveillance Technique for Detecting and Locating Bioagent Attacks

DTIC Science & Technology

2003-06-10

Implementation • Location History – Location tracking/storage using cell - phone network (geo-location mandated by 2006) • Subscription Services...Reporting – User reports symptoms through automated cell - phone interface using password Individual reports only releasable with password Summary...Earlier detection and location relative to medical surveillance • The cell - phone location based service market can offer a means to implement BACTrack and to distribute its costs

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

2017-11-01

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.

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.

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.

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

[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.

DEFENSE MEDICAL SURVEILLANCE SYSTEM (DMSS)

EPA Science Inventory

AMSA operates the Defense Medical Surveillance System (DMSS), an executive information system whose database contains up-to-date and historical data on diseases and medical events (e.g., hospitalizations, ambulatory visits, reportable diseases, HIV tests, acute respiratory diseas...

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.

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.

Establishing a cost-effective national surveillance system for Bluetongue using scenario tree modelling.

PubMed

Hadorn, Daniela C; Racloz, Vanessa; Schwermer, Heinzpeter; Stärk, Katharina D C

2009-01-01

Vector-borne diseases pose a special challenge to veterinary authorities due to complex and time-consuming surveillance programs taking into account vector habitat. Using stochastic scenario tree modelling, each possible surveillance activity of a future surveillance system can be evaluated with regard to its sensitivity and the expected cost. The overall sensitivity of various potential surveillance systems, composed of different combinations of surveillance activities, is calculated and the proposed surveillance system is optimized with respect to the considered surveillance activities, the sensitivity and the cost. The objective of this project was to use stochastic scenario tree modelling in combination with a simple cost analysis in order to develop the national surveillance system for Bluetongue in Switzerland. This surveillance system was established due to the emerging outbreak of Bluetongue virus serotype 8 (BTV-8) in Northern Europe in 2006. Based on the modelling results, it was decided to implement an improved passive clinical surveillance in cattle and sheep through campaigns in order to increase disease awareness alongside a targeted bulk milk testing strategy in 200 dairy cattle herds located in high-risk areas. The estimated median probability of detection of cases (i.e. sensitivity) of the surveillance system in this combined approach was 96.4%. The evaluation of the prospective national surveillance system predicted that passive clinical surveillance in cattle would provide the highest probability to detect BTV-8 infected animals, followed by passive clinical surveillance in sheep and bulk milk testing of 200 dairy cattle farms in high-risk areas. This approach is also applicable in other countries and to other epidemic diseases.

Efficacy and safety of nifedipine GITS in Chinese patients with hypertension--a post-marketing surveillance study.

PubMed

Huo, Yong; Zhang, Jian; He, Qing; Chen, Hong; Ma, Jishun; Landen, Harald

2007-03-01

This post-marketing surveillance study assessed the efficacy, safety and tolerability of the treatment with nifedipine GITS (gastro-intestinal therapeutic system) in hypertensive patients under normal daily practice conditions in China. A total of 3003 patients were included in 174 outpatient clinics. Patients received 30 mg or 60 mg of nifedipine GITS. Data were collected at up to three follow-up visits. At the end of the observation period, mean treatment duration was 13.3 weeks. Mean blood pressure reduction was 27.6/13.6 mmHg, 62.1% of patients had a systolic blood pressure <140 mmHg, and 82.2% had a diastolic blood pressure <90 mmHg. Blood pressure control according to international guidelines was achieved in 45.0% of all patients. A total of 1515 patients received additional antihypertensive medications, of which angiotensin-converting enzyme (ACE) inhibitors were mostly used (42.2%) followed by beta-blockers (33.7%). Twenty-two patients (0.7%) experienced 27 adverse events. Physicians' assessments of efficacy, tolerability and patient acceptance had ratings of "very good" and "good" in 88.7% (efficacy), 92.8% (tolerability) and 89.1% (patient acceptance) of patients. Nifedipine GITS proved to be effective and well tolerated for the treatment of hypertension in 3003 Chinese patients. The results confirm the findings of previously performed clinical studies.

Using Acute Flaccid Paralysis Surveillance as a Platform for Vaccine-Preventable Disease Surveillance.

PubMed

Wassilak, Steven G F; Williams, Cheryl L; Murrill, Christopher S; Dahl, Benjamin A; Ohuabunwo, Chima; Tangermann, Rudolf H

2017-07-01

Surveillance for acute flaccid paralysis (AFP) is a fundamental cornerstone of the global polio eradication initiative (GPEI). Active surveillance (with visits to health facilities) is a critical strategy of AFP surveillance systems for highly sensitive and timely detection of cases. Because of the extensive resources devoted to AFP surveillance, multiple opportunities exist for additional diseases to be added using GPEI assets, particularly because there is generally 1 district officer responsible for all disease surveillance. For this reason, integrated surveillance has become a standard practice in many countries, ranging from adding surveillance for measles and rubella to integrated disease surveillance for outbreak-prone diseases (integrated disease surveillance and response). This report outlines the current level of disease surveillance integration in 3 countries (Nepal, India, and Nigeria) and proposes that resources continue for long-term maintenance in resource-poor countries of AFP surveillance as a platform for surveillance of vaccine-preventable diseases and other outbreak-prone diseases. © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America.

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

DOE Office of Scientific and Technical Information (OSTI.GOV)

Chris Zingarelli, J.; Cain, Stephen; Pearce, Eric

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 testsmore » 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.« less

Delayed and Unreported Drug-Susceptibility Testing Results in the US National Tuberculosis Surveillance System, 1993-2014.

PubMed

Jones, Jefferson Michael; Armstrong, Lori R

Drug-susceptibility testing (DST) of Mycobacterium tuberculosis is necessary for identifying drug-resistant tuberculosis, administering effective treatment regimens, and preventing the spread of drug-resistant tuberculosis. DST is recommended for all culture-confirmed cases of tuberculosis. We examined trends in delayed and unreported DST results in the Centers for Disease Control and Prevention's National Tuberculosis Surveillance System. We analyzed culture-confirmed tuberculosis cases reported to the National Tuberculosis Surveillance System during 1993-2014 for annual trends in initial DST reporting for first-line antituberculosis drugs and trends in on-time, delayed, and unreported results. We defined on-time reporting as DST results received during the same calendar year in which the patient's case was reported or ≤4 months after the calendar year ended and delayed reporting as DST results received after the calendar year. We compared cases with on-time, delayed, and unreported DST results by patient and tuberculosis program characteristics. The proportion of cases with reported results for all first-line antituberculosis drugs increased during 1993-2011. Reporting of pyrazinamide results was lower than reporting of other drugs. However, during 2000-2012, of 134 787 tuberculosis cases reported to the National Tuberculosis Surveillance System, reporting was on time for 125 855 (93.4%) cases, delayed for 5332 (4.0%) cases, and unreported for 3600 (2.7%) cases. Despite increases in the proportion of cases with on-time DST results, delayed and unreported results persisted. Carefully assessing causes for delayed and unreported DST results should lead to more timely reporting of drug-resistant tuberculosis.

[Surveillance of phytotherapeutic drugs in the state of Minas Gerais. Quality assessment of commercial samples of chamomile].

PubMed

Brandão, M G; Freire, N; Vianna-Soares, C D

1998-01-01

Marketing of medicinal plants and phytotherapeutic products is spreading all over the world. In order to assess the commercialization of medicinal plants and phytotherapeutic products in the State of Minas Gerais, we identified and tested for the presence of adulterants and active ingredients in 27 samples of chamomile. All the samples consisted of Matricaria recutita flowers, but they were badly fragmented, a result of excessive handling and poor preservation. All samples contained contaminants, and insects were observed in 63% of the samples sold in drugstores. Only 50% of the samples in each group had the essential oils needed to produce antiinflammatory activity. Flavonoids and other phenolic constituents with a spasmolytic effect were detected in only 20% of the samples from each group. Results with chamomile indicated the poor quality with which medicinal plants and phytotherapeutic products are marketed and confirm the need for surveillance of such products in Brazil.

Multicenter, noninterventional, post-marketing surveillance study to evaluate dosing of recombinant human follicle-stimulating hormone using the redesigned follitropin alfa pen in women undergoing ovulation induction

PubMed Central

Nawroth, Frank; Tandler-Schneider, Andreas; Bilger, Wilma

2015-01-01

This prospective, noninterventional, post-marketing surveillance study evaluated doses of recombinant human follicle-stimulating hormone (r-hFSH) using the redesigned follitropin alfa pen in women who were anovulatory or oligomenorrheic and undergoing ovulation induction (OI) alone or OI with intrauterine insemination. The primary endpoint was the proportion of patients who achieved monofollicular or bifollicular development (defined as one or two follicles ≥15 mm). Secondary endpoints included characteristics of ovulation stimulation treatment, such as mean total and mean daily r-hFSH doses. Data were analyzed for 3,193 patients from 30 German fertility centers. The proportion of patients with monofollicular or bifollicular development was 71.1% (n=2,270 of a total of 3,193 patients; intent-to-treat population). The mean±standard deviation total and daily doses of r-hFSH were 696.9±542.5 IU and 61.7±29.4 IU, respectively. The three doses prescribed most frequently were: 37.5 IU (n=703 from N=3,189; 22.0%), 50.0 IU (n=1,056 from N=3,189; 33.1%), and 75.0 IU (n=738 from N=3,189; 23.1%) on the first day of stimulation; and 37.5 IU (n=465 from N=3,189; 14.6%), 50.0 IU (n=922 from N=3,189; 28.9%), and 75.0 IU (n=895 from N=3,189; 28.1%) on the last day of stimulation. This noninterventional, post-marketing surveillance study found that monofollicular or bifollicular development was achieved in 71% of patients studied and the small dose increment (12.5 IU) of the redesigned follitropin alfa pen allowed individualized treatment of women undergoing OI. PMID:25926755

Photovoltaic remote instrument applications: Assessment of the near-term market

NASA Technical Reports Server (NTRS)

Rosenblum, L.; Scudder, L. R.; Poley, W. A.; Bifano, W. J.

1977-01-01

A preliminary assessment of the near term market for photovoltaic remote instrument applications is presented. Among the potential users, two market sectors are considered: government and private. However, the majority of the remote systems studied are operated by or for the federal, state, or local governments. Environmental monitoring and surveillance remote instrument systems are discussed. Based on information obtained in this preliminary market survey, a domestic, civilian market of at least 1.3 MW sub pk is forecast for remote instrument systems. This estimate is exclusive of several potentially large scale markets for remote instruments which are identified but for which no hard data is available.

Safety and efficacy of canagliflozin in elderly patients with type 2 diabetes mellitus: a 1-year post-marketing surveillance in Japan.

PubMed

Goda, Maki; Yamakura, Tomoko; Sasaki, Kazuyo; Tajima, Takumi; Ueno, Makoto

2018-02-01

To evaluate the safety and efficacy of canagliflozin in elderly patients with type 2 diabetes mellitus (T2DM) in clinical settings. The authors conducted a 1-year post-marketing surveillance (PMS) of canagliflozin in almost all the elderly patients (≥65 years old) with T2DM who began taking canagliflozin during the first 3 months after its launch in Japan. The main outcomes included the incidences of adverse drug reactions (ADRs), serious ADRs, and the changes of laboratory tests as well as efficacy variables. An ADR was reported in 9.09% (125 of 1375 patients) in the safety analysis set. The main ADRs were dehydration, constipation, thirst, pollakiuria, dizziness, cystitis, eczema, pruritus, and rash. The incidence of serious ADRs was 1.02% (14 patients), which included urinary tract infection, dehydration, hypoglycemia, and cerebral infarction (two patients each). ADRs of special interest that had been reported in clinical trials of SGLT2 inhibitors, such as hypoglycemia, volume depletion-related events, genital/urinary tract infection, polyuria/pollakiuria, and ketone body increased were also observed in this PMS. The safety profiles were similar to the results of a previous clinical study of canagliflozin, and new safety concerns were not identified in this survey. The mean change in HbA1c was -0.77% after 12 months of treatment in the efficacy analysis set. In this PMS, the safety and efficacy profiles of canagliflozin in elderly patients with T2DM were obtained in the clinical settings in Japan and the drug was well tolerated and effective in improving glycemic control.

Marketing Practices of Vapor Store Owners

PubMed Central

Gowin, Mary; Wann, Taylor Franklin

2015-01-01

Objectives. We examined the marketing strategies for local vapor stores in a large metropolitan area in Oklahoma. Methods. Vapor store owners or managers (n = 33) participated in individual interviews regarding marketing practices in 2014. We asked owners about their marketing strategies and the groups they targeted. We transcribed the interviews and analyzed them for themes. Results. Store owners used a variety of marketing strategies to bring new customers to their stores and keep current customers coming back. These marketing strategies showed many parallels to tobacco industry strategies. Most owners engaged in some form of traditional marketing practices (e.g., print media), but only a few used radio or television advertising because of budget constraints. Owners used social media and other forms of electronic communication, pricing discounts and specials, and loyalty programs. Owners also had booths at local events, sponsored community events, and hosted them in their stores. Owners attempted to target different groups of users, such as college students and long-term smokers. Conclusions. Local vapor store marketing practices closely resemble current and former tobacco industry marketing strategies. Surveillance of marketing practices should include local and Web-based strategies. PMID:25880960

Marketing practices of vapor store owners.

PubMed

Cheney, Marshall; Gowin, Mary; Wann, Taylor Franklin

2015-06-01

We examined the marketing strategies for local vapor stores in a large metropolitan area in Oklahoma. Vapor store owners or managers (n = 33) participated in individual interviews regarding marketing practices in 2014. We asked owners about their marketing strategies and the groups they targeted. We transcribed the interviews and analyzed them for themes. Store owners used a variety of marketing strategies to bring new customers to their stores and keep current customers coming back. These marketing strategies showed many parallels to tobacco industry strategies. Most owners engaged in some form of traditional marketing practices (e.g., print media), but only a few used radio or television advertising because of budget constraints. Owners used social media and other forms of electronic communication, pricing discounts and specials, and loyalty programs. Owners also had booths at local events, sponsored community events, and hosted them in their stores. Owners attempted to target different groups of users, such as college students and long-term smokers. Local vapor store marketing practices closely resemble current and former tobacco industry marketing strategies. Surveillance of marketing practices should include local and Web-based strategies.

Post-marketing surveillance data of thrombomodulin alfa: sub-analysis in patients with sepsis-induced disseminated intravascular coagulation.

PubMed

Eguchi, Yutaka; Gando, Satoshi; Ishikura, Hiroyasu; Saitoh, Daizoh; Mimuro, Jun; Takahashi, Hoyu; Kitajima, Isao; Tsuji, Hajime; Matsushita, Tadashi; Tsujita, Ryuichi; Nagao, Osamu; Sakata, Yoichi

2014-01-01

Thrombomodulin alfa (TM-α, recombinant thrombomodulin) significantly improved disseminated intravascular coagulation (DIC) when compared with heparin therapy in a phase III study. Post-marketing surveillance of TM-α was performed to evaluate the effects and safety in patients with sepsis-induced DIC. From May 2008 to April 2010, a total of 1,787 patients with sepsis-induced DIC treated with TM-α were registered. DIC was diagnosed based on the Japanese Association for Acute Medicine (JAAM) criteria. The DIC resolution and survival rates on day 28 after the last TM-α administration, and changes in DIC, systemic inflammatory response syndrome (SIRS), and sequential organ failure assessment (SOFA) scores and coagulation and inflammation markers were evaluated. The most frequent underlying disease was infectious focus-unknown sepsis (29.8%). The mean ± SD values of age, dose, and the duration of TM-α administration were 64.7 ± 20.3 years, 297.3 ± 111.4 U/kg/day, and 5.6 ± 3.4 days, respectively. A total of 1,320 subjects (73.9%) received combined administration with other anticoagulants. Both coagulation and inflammation markers, such as fibrin/fibrinogen degradation products, prothrombin time ratio, thrombin-antithrombin complex, and C-reactive protein, as well as JAAM DIC, SIRS, and SOFA scores, significantly and simultaneously decreased after TM-α administration (p < 0.001). DIC resolution and 28-day survival rates were 44.4% and 66.0%, respectively. The 28-day survival rate decreased significantly according to the duration of DIC before TM-α administration (p < 0.001). Total adverse drug reactions (ADRs), bleeding ADRs, and serious bleeding adverse events occurred in 126 (7.1%), 98 (5.5%), and 121 (6.8%) subjects, respectively. On day 28, after the last TM-α administration available for an antibody test, only one patient was positive for anti-TM-α antibodies (0.11%). Our results suggest that TM-α is most effective for treating

in silico Surveillance: evaluating outbreak detection with simulation models

PubMed Central

2013-01-01

Background Detecting outbreaks is a crucial task for public health officials, yet gaps remain in the systematic evaluation of outbreak detection protocols. The authors’ objectives were to design, implement, and test a flexible methodology for generating detailed synthetic surveillance data that provides realistic geographical and temporal clustering of cases and use to evaluate outbreak detection protocols. Methods A detailed representation of the Boston area was constructed, based on data about individuals, locations, and activity patterns. Influenza-like illness (ILI) transmission was simulated, producing 100 years of in silico ILI data. Six different surveillance systems were designed and developed using gathered cases from the simulated disease data. Performance was measured by inserting test outbreaks into the surveillance streams and analyzing the likelihood and timeliness of detection. Results Detection of outbreaks varied from 21% to 95%. Increased coverage did not linearly improve detection probability for all surveillance systems. Relaxing the decision threshold for signaling outbreaks greatly increased false-positives, improved outbreak detection slightly, and led to earlier outbreak detection. Conclusions Geographical distribution can be more important than coverage level. Detailed simulations of infectious disease transmission can be configured to represent nearly any conceivable scenario. They are a powerful tool for evaluating the performance of surveillance systems and methods used for outbreak detection. PMID:23343523

Secure Video Surveillance System (SVSS) for unannounced safeguards inspections.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Galdoz, Erwin G.; Pinkalla, Mark

2010-09-01

The Secure Video Surveillance System (SVSS) is a collaborative effort between the U.S. Department of Energy (DOE), Sandia National Laboratories (SNL), and the Brazilian-Argentine Agency for Accounting and Control of Nuclear Materials (ABACC). The joint project addresses specific requirements of redundant surveillance systems installed in two South American nuclear facilities as a tool to support unannounced inspections conducted by ABACC and the International Atomic Energy Agency (IAEA). The surveillance covers the critical time (as much as a few hours) between the notification of an inspection and the access of inspectors to the location in facility where surveillance equipment is installed.more » ABACC and the IAEA currently use the EURATOM Multiple Optical Surveillance System (EMOSS). This outdated system is no longer available or supported by the manufacturer. The current EMOSS system has met the project objective; however, the lack of available replacement parts and system support has made this system unsustainable and has increased the risk of an inoperable system. A new system that utilizes current technology and is maintainable is required to replace the aging EMOSS system. ABACC intends to replace one of the existing ABACC EMOSS systems by the Secure Video Surveillance System. SVSS utilizes commercial off-the shelf (COTS) technologies for all individual components. Sandia National Laboratories supported the system design for SVSS to meet Safeguards requirements, i.e. tamper indication, data authentication, etc. The SVSS consists of two video surveillance cameras linked securely to a data collection unit. The collection unit is capable of retaining historical surveillance data for at least three hours with picture intervals as short as 1sec. Images in .jpg format are available to inspectors using various software review tools. SNL has delivered two SVSS systems for test and evaluation at the ABACC Safeguards Laboratory. An additional 'proto-type' system

Utility of risk-based chlamydia testing in primary care: analysis of retrospective surveillance data among women in Melbourne, Australia.

PubMed

Wilkinson, Anna L; McNamee, Kathleen; El-Hayek, Carol; Chow, Eric P F; Bradshaw, Catriona S; Roth, Norm; Tee, B K; Stoové, Mark; Hellard, Margaret

2017-06-01

Background Chlamydia (Chlamydia trachomatis) continues to be a public health challenge in Australia, with some contention as to the best screening approach. In the present study we examined chlamydia testing, positivity and sexual behaviour among women with the aim of informing targeted testing among women aged ≥30 years. A longitudinal analysis was conducted on retrospective surveillance data collected among women attending general practice, family planning and sexual health clinics participating in sentinel surveillance in Melbourne, Australia. Women were aged ≥16 years and underwent urogenital testing for C. trachomatis (chlamydia) at participating clinics between 2007 and 2014. Chlamydia incidence was calculated as positive chlamydia tests over person-years (PY) among women and reported by 5-year age groups. A Cox regression model examined correlates of a positive chlamydia test among women aged ≥30 years. In all, 36770 women contributed 46432 PY and 52395 chlamydia tests, of which 2895 were positive. The overall chlamydia incidence rate was 6.2 per 100 PY (95% confidence interval (CI) 6.0-6.5). Chlamydia incidence declined with age, plateauing to <5 per 100 PY among women aged ≥30 years. Among women aged ≥30 years, being born in North-East Asia (adjusted hazard ratio (aHR) 2.9; 95% CI 1.9-4.5) and reporting multiple partners (aHR 2.5; 95% CI 1.8-3.5) in the past 12 months were associated with a positive chlamydia test. Chlamydia control remains challenging in Australia and optimising testing in primary care is a key priority. The results of the present study suggest that, at least among women aged ≥30 years, chlamydia testing should be risk-based and informed by appropriate sexual history taking.

Semantic-based surveillance video retrieval.

PubMed

Hu, Weiming; Xie, Dan; Fu, Zhouyu; Zeng, Wenrong; Maybank, Steve

2007-04-01

Visual surveillance produces large amounts of video data. Effective indexing and retrieval from surveillance video databases are very important. Although there are many ways to represent the content of video clips in current video retrieval algorithms, there still exists a semantic gap between users and retrieval systems. Visual surveillance systems supply a platform for investigating semantic-based video retrieval. In this paper, a semantic-based video retrieval framework for visual surveillance is proposed. A cluster-based tracking algorithm is developed to acquire motion trajectories. The trajectories are then clustered hierarchically using the spatial and temporal information, to learn activity models. A hierarchical structure of semantic indexing and retrieval of object activities, where each individual activity automatically inherits all the semantic descriptions of the activity model to which it belongs, is proposed for accessing video clips and individual objects at the semantic level. The proposed retrieval framework supports various queries including queries by keywords, multiple object queries, and queries by sketch. For multiple object queries, succession and simultaneity restrictions, together with depth and breadth first orders, are considered. For sketch-based queries, a method for matching trajectories drawn by users to spatial trajectories is proposed. The effectiveness and efficiency of our framework are tested in a crowded traffic scene.

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…

40 CFR 172.8 - Program surveillance and reporting of data.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 23 2010-07-01 2010-07-01 false Program surveillance and reporting of data. 172.8 Section 172.8 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED... surveillance and reporting of data. (a) The permittee shall supervise the test program and evaluate the results...

40 CFR 172.8 - Program surveillance and reporting of data.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 25 2013-07-01 2013-07-01 false Program surveillance and reporting of data. 172.8 Section 172.8 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED... surveillance and reporting of data. (a) The permittee shall supervise the test program and evaluate the results...

40 CFR 172.8 - Program surveillance and reporting of data.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 25 2012-07-01 2012-07-01 false Program surveillance and reporting of data. 172.8 Section 172.8 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED... surveillance and reporting of data. (a) The permittee shall supervise the test program and evaluate the results...

40 CFR 172.8 - Program surveillance and reporting of data.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 24 2011-07-01 2011-07-01 false Program surveillance and reporting of data. 172.8 Section 172.8 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED... surveillance and reporting of data. (a) The permittee shall supervise the test program and evaluate the results...

40 CFR 172.8 - Program surveillance and reporting of data.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 24 2014-07-01 2014-07-01 false Program surveillance and reporting of data. 172.8 Section 172.8 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED... surveillance and reporting of data. (a) The permittee shall supervise the test program and evaluate the results...

Linking HIV and antiretroviral drug resistance surveillance in Peru: a model for a third-generation HIV sentinel surveillance.

PubMed

Lama, Javier R; Sanchez, Jorge; Suarez, Luis; Caballero, Patricia; Laguna, Alberto; Sanchez, Jose L; Whittington, William L H; Celum, Connie; Grant, Robert M

2006-08-01

HIV drug resistance surveillance is limited by recruitment and selection bias and by limited information regarding HIV incidence rates, secondary resistance, and treatment prevalence. A second-generation HIV sentinel surveillance among men who have sex with men (MSM), regardless of prior history of HIV screening, serostatus, or treatment, was conducted in Peru in 2002. Recent HIV infection was estimated using sensitive/less sensitive enzyme immunoassay testing. Genotypic resistance testing was performed. HIV prevalence was 13.9% (456 HIV positive of 3280 participants). HIV incidence was estimated to be 5.1 per 100 person-years (95% confidence interval: 3.1-8.3). Among 143 MSM who were aware of their HIV infection before testing, only 20 (14.0%) were receiving antiretrovirals (ARV). Mutations conferring ARV resistance were found in 12 (3.3%) of 359 treatment-naive and 5 (31.3%) of 16 treatment-experienced participants with successful genotyping. One recently infected man from Lima demonstrated 3-class multidrug resistance. The most frequently observed mutations in treatment-naive, chronically infected persons from Lima were M184V (1.7%), D30N (1.3%), L90M (1.3%), and L10I (1.3%). The prevalence of ARV resistance among treatment-naive MSM in Peru is low, reflecting limited access to treatment before 2004, and contrasts with the history of ARV treatment in developed countries, where high levels of nucleoside reverse transcriptase inhibitor resistance occurred before introduction of highly active antiretroviral therapy. Linking ARV resistance and HIV sentinel surveillance in developing settings is feasible and should be considered in third-generation HIV sentinel surveillance programs.

Value of lower respiratory tract surveillance cultures to predict bacterial pathogens in ventilator-associated pneumonia: systematic review and diagnostic test accuracy meta-analysis.

PubMed

Brusselaers, Nele; Labeau, Sonia; Vogelaers, Dirk; Blot, Stijn

2013-03-01

In ventilator-associated pneumonia (VAP), early appropriate antimicrobial therapy may be hampered by involvement of multidrug-resistant (MDR) pathogens. A systematic review and diagnostic test accuracy meta-analysis were performed to analyse whether lower respiratory tract surveillance cultures accurately predict the causative pathogens of subsequent VAP in adult patients. Selection and assessment of eligibility were performed by three investigators by mutual consideration. Of the 525 studies retrieved, 14 were eligible for inclusion (all in English; published since 1994), accounting for 791 VAP episodes. The following data were collected: study and population characteristics; in- and exclusion criteria; diagnostic criteria for VAP; microbiological workup of surveillance and diagnostic VAP cultures. Sub-analyses were conducted for VAP caused by Staphylococcus aureus, Pseudomonas spp., and Acinetobacter spp., MDR microorganisms, frequency of sampling, and consideration of all versus the most recent surveillance cultures. The meta-analysis showed a high accuracy of surveillance cultures, with pooled sensitivities up to 0.75 and specificities up to 0.92 in culture-positive VAP. The area under the curve (AUC) of the hierarchical summary receiver-operating characteristic curve demonstrates moderate accuracy (AUC: 0.90) in predicting multidrug resistance. A sampling frequency of >2/week (sensitivity 0.79; specificity 0.96) and consideration of only the most recent surveillance culture (sensitivity 0.78; specificity 0.96) are associated with a higher accuracy of prediction. This study provides evidence for the benefit of surveillance cultures in predicting MDR bacterial pathogens in VAP. However, clinical and statistical heterogeneity, limited samples sizes, and bias remain important limitations of this meta-analysis.

Assays for estimating HIV incidence: updated global market assessment and estimated economic value.

PubMed

Morrison, Charles S; Homan, Rick; Mack, Natasha; Seepolmuang, Pairin; Averill, Megan; Taylor, Jamilah; Osborn, Jennifer; Dailey, Peter; Parkin, Neil; Ongarello, Stefano; Mastro, Timothy D

2017-11-01

Accurate incidence estimates are needed to characterize the HIV epidemic and guide prevention efforts. HIV Incidence assays are cost-effective laboratory assays that provide incidence estimates from cross-sectional surveys. We conducted a global market assessment of HIV incidence assays under three market scenarios and estimated the economic value of improved incidence assays. We interviewed 27 stakeholders, and reviewed journal articles, working group proceedings, and manufacturers' sales figures. We determined HIV incidence assay use in 2014, and estimated use in 2015 to 2017 and in 5 to 10-years under three market scenarios, as well as the cost of conducting national and key population surveys using an HIV incidence assay with improved performance. Global 2014 HIV incidence assay use was 308,900 tests, highest in Asia and mostly for case- and population-based surveillance. Estimated 2015 to 2017 use was 94,475 annually, with declines due to China and the United States discontinuing incidence assay use for domestic surveillance. Annual projected 5 to 10 year use under scenario 1 - no change in technology - was 94,475. For scenario 2 - a moderately improved incidence assay - projected annual use was 286,031. Projected annual use for scenario 3 - game-changing technologies with an HIV incidence assay part of (a) standard confirmatory testing, and (b) standard rapid testing, were 500,000 and 180 million, respectively. As HIV incidence assay precision increases, decreased sample sizes required for incidence estimation resulted in $5 to 23 million annual reductions in survey costs and easily offset the approximately $3 million required to develop a new assay. Improved HIV incidence assays could substantially reduce HIV incidence estimation costs. Continued development of HIV incidence assays with improved performance is required to realize these cost benefits. © 2017 The Authors. Journal of the International AIDS Society published by John Wiley & sons Ltd on

The critical role of acute flaccid paralysis surveillance in the Global Polio Eradication Initiative.

PubMed

Tangermann, Rudolf H; Lamoureux, Christine; Tallis, Graham; Goel, Ajay

2017-05-01

Acute flaccid paralysis (AFP) surveillance is a key strategy used by the Global Polio Eradication Initiative (GPEI) to measure progress towards reaching the global eradication goal. Supported by a global polio laboratory network, AFP surveillance is conducted in 179 of 194 WHO member states. Active surveillance visits to priority health facilities are used to assure all children <15 years with AFP are detected, followed by stool specimen collection and testing for poliovirus in WHO-accredited polio laboratories. The quality of AFP surveillance is regularly monitored with standardized surveillance quality indicators. In highest risk countries and areas, the sensitivity of AFP surveillance is enhanced by environmental surveillance (testing of sewage samples). Genetic sequencing of detected poliovirus isolates yields programmatically important information on polio transmission pathways. AFP surveillance is one of the most valuable assets of the GPEI, with the potential to serve as a platform to build integrated disease surveillance systems. Continued support to maintain AFP surveillance systems will be essential, to reliably monitor the completion of global polio eradication, and to assure that a key resource for building surveillance capacity is transitioned post-eradication to support other health priorities. © The Author 2017. Published by Oxford University Press on behalf of Royal Society of Tropical Medicine and Hygiene. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Impact of intervention surveillance bias on analyses of child welfare report outcomes.

PubMed

Chaffin, Mark; Bard, David

2006-11-01

Two studies using data from child maltreatment intervention outcome evaluations were conducted examining several aspects of surveillance bias, including directly measuring rates of surveillance reporting, comparing characteristics of surveillance versus nonsurveillance reports, examining differences across service types and doses, and testing how ignoring versus removing surveillance reports in the data affects survival analysis. The net effect of surveillance bias was small in the studies examined. Home-visiting services were not biased more than center-based services, and bias was not greater among intervention compared to prevention cases. Surveillance reports were equally as severe as nonsurveillance reports, failing to support the hypothesis that surveillance serves as early detection of less severe maltreatment. However, surveillance bias was far more substantial during time periods when participants were actively engaged in services. Therefore, the net impact of surveillance could vary with service engagement rates and the relative duration of service engagement and postservice follow-up times.

Cost-effectiveness of lobectomy versus genetic testing (Afirma®) for indeterminate thyroid nodules: Considering the costs of surveillance.

PubMed

Balentine, Courtney J; Vanness, David J; Schneider, David F

2018-01-01

We evaluated whether diagnostic thyroidectomy for indeterminate thyroid nodules would be more cost-effective than genetic testing after including the costs of long-term surveillance. We used a Markov decision model to estimate the cost-effectiveness of thyroid lobectomy versus genetic testing (Afirma®) for evaluation of indeterminate (Bethesda 3-4) thyroid nodules. The base case was a 40-year-old woman with a 1-cm indeterminate nodule. Probabilities and estimates of utilities were obtained from the literature. Cost estimates were based on Medicare reimbursements with a 3% discount rate for costs and quality-adjusted life-years. During a 5-year period after the diagnosis of indeterminate thyroid nodules, lobectomy was less costly and more effective than Afirma® (lobectomy: $6,100; 4.50 quality-adjusted life- years vs Afirma®: $9,400; 4.47 quality-adjusted life-years). Only in 253 of 10,000 simulations (2.5%) did Afirma® show a net benefit at a cost-effectiveness threshold of $100,000 per quality- adjusted life-years. There was only a 0.3% probability of Afirma® being cost saving and a 14.9% probability of improving quality-adjusted life-years. Our base case estimate suggests that diagnostic lobectomy dominates genetic testing as a strategy for ruling out malignancy of indeterminate thyroid nodules. These results, however, were highly sensitive to estimates of utilities after lobectomy and living under surveillance after Afirma®. Published by Elsevier Inc.

Seven-Year Clinical Surveillance Program Demonstrates Consistent MARD Accuracy Performance of a Blood Glucose Test Strip.

PubMed

Setford, Steven; Grady, Mike; Mackintosh, Stephen; Donald, Robert; Levy, Brian

2018-05-01

MARD (mean absolute relative difference) is increasingly used to describe performance of glucose monitoring systems, providing a single-value quantitative measure of accuracy and allowing comparisons between different monitoring systems. This study reports MARDs for the OneTouch Verio® glucose meter clinical data set of 80 258 data points (671 individual batches) gathered as part of a 7.5-year self-surveillance program Methods: Test strips were routinely sampled from randomly selected manufacturer's production batches and sent to one of 3 clinic sites for clinical accuracy assessment using fresh capillary blood from patients with diabetes, using both the meter system and standard laboratory reference instrument. Evaluation of the distribution of strip batch MARD yielded a mean value of 5.05% (range: 3.68-6.43% at ±1.96 standard deviations from mean). The overall MARD for all clinic data points (N = 80 258) was also 5.05%, while a mean bias of 1.28 was recorded. MARD by glucose level was found to be consistent, yielding a maximum value of 4.81% at higher glucose (≥100 mg/dL) and a mean absolute difference (MAD) of 5.60 mg/dL at low glucose (<100 mg/dL). MARD by year of manufacture varied from 4.67-5.42% indicating consistent accuracy performance over the surveillance period. This 7.5-year surveillance program showed that this meter system exhibits consistently low MARD by batch, glucose level and year, indicating close agreement with established reference methods whilste exhibiting lower MARD values than continuous glucose monitoring (CGM) systems and providing users with confidence in the performance when transitioning to each new strip batch.

S-band range tracker and Surveillance Lab interface

NASA Astrophysics Data System (ADS)

Bush, B. D.

1983-09-01

This report documents the design, construction, test and laboratory integration of the range tracker and associated subsystems for the RADC/OC Surveillance Laboratory's S-Band tracking radar. This development was accomplished over the period from December 1981 to November 1983 and was designed, constructed and tested entirely in-house. This report contains information on the use of the range tracker, its interfaces to other laboratory equipment, the philosophy behind its design, the detailed design of the hardware (including schematics, timing and cabling diagrams), the detailed software design (including flowcharts), and the mathematical description of its algorithms. The range tracker will be used in conjunction with other equipment in the OC Surveillance Lab in the taking and recording of radar data during flight tests.

Infectious Disease Surveillance in the Big Data Era: Towards Faster and Locally Relevant Systems.

PubMed

Simonsen, Lone; Gog, Julia R; Olson, Don; Viboud, Cécile

2016-12-01

While big data have proven immensely useful in fields such as marketing and earth sciences, public health is still relying on more traditional surveillance systems and awaiting the fruits of a big data revolution. A new generation of big data surveillance systems is needed to achieve rapid, flexible, and local tracking of infectious diseases, especially for emerging pathogens. In this opinion piece, we reflect on the long and distinguished history of disease surveillance and discuss recent developments related to use of big data. We start with a brief review of traditional systems relying on clinical and laboratory reports. We then examine how large-volume medical claims data can, with great spatiotemporal resolution, help elucidate local disease patterns. Finally, we review efforts to develop surveillance systems based on digital and social data streams, including the recent rise and fall of Google Flu Trends. We conclude by advocating for increased use of hybrid systems combining information from traditional surveillance and big data sources, which seems the most promising option moving forward. Throughout the article, we use influenza as an exemplar of an emerging and reemerging infection which has traditionally been considered a model system for surveillance and modeling. Published by Oxford University Press for the Infectious Diseases Society of America 2016. This work is written by (a) US Government employee(s) and is in the public domain in the US.

Methodological comparisons for antimicrobial resistance surveillance in feedlot cattle

PubMed Central

2013-01-01

Background The purpose of this study was to objectively compare methodological approaches that might be utilized in designing an antimicrobial resistance (AMR) surveillance program in beef feedlot cattle. Specifically, four separate comparisons were made to investigate their potential impact on estimates for prevalence of AMR. These included investigating potential differences between 2 different susceptibility testing methods (broth microdilution and disc diffusion), between 2 different target bacteria (non-type-specific E. coli [NTSEC] and Mannheimia haemolytica), between 2 strategies for sampling feces (individual samples collected per rectum and pooled samples collected from the pen floor), and between 2 strategies for determining which cattle to sample (cattle that were culture-positive for Mannheimia haemolytica and those that were culture-negative). Results Comparing two susceptibility testing methods demonstrated differences in the likelihood of detecting resistance between automated disk diffusion (BioMIC®) and broth microdilution (Sensititre®) for both E. coli and M. haemolytica. Differences were also detected when comparing resistance between two bacterial organisms within the same cattle; there was a higher likelihood of detecting resistance in E. coli than in M. haemolytica. Differences in resistance prevalence were not detected when using individual animal or composite pen sampling strategies. No differences in resistance prevalences were detected in E. coli recovered from cattle that were culture-positive for M. haemolytica compared to those that were culture-negative, suggesting that sampling strategies which targeted recovery of E. coli from M. haemolytica-positive cattle would not provide biased results. Conclusions We found that for general purposes, the susceptibility test selected for AMR surveillance must be carefully chosen considering the purpose of the surveillance since the ability to detect resistance appears to vary between these tests

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.

Surveillance of transmitted HIV drug resistance using matched plasma and dried blood spot specimens from voluntary counseling and testing sites in Ho Chi Minh City, Vietnam, 2007-2008.

PubMed

Duc, Nguyen Bui; Hien, Bui Thu; Wagar, Nick; Tram, Tran Hong; Giang, Le Truong; Yang, Chunfu; Wolfe, Mitchell I; Hien, Nguyen Tran; Tuan, Nguyen Anh

2012-05-01

During 2007-2008, surveillance of transmitted human immunodeficiency virus (HIV) drug resistance (TDR) was performed following World Health Organization guidance among clients with newly diagnosed HIV infection attending voluntary counseling and testing (VCT) sites in Ho Chi Minh City (HCMC), Vietnam. Moderate (5%-15%) TDR to nonnucleoside reverse-transcriptase inhibitors (NNRTIs) was observed among VCT clients aged 18-21 years. Follow-up surveillance of TDR in HCMC and other geographic regions of Vietnam is warranted. Data generated will guide the national HIV drug resistance surveillance strategy and support selection of current and future first-line antiretroviral therapy and HIV prevention programs.

Post-marketing surveillance of the safety and effectiveness of tacrolimus in 3,267 Japanese patients with rheumatoid arthritis.

PubMed

Takeuchi, Tsutomu; Kawai, Shinichi; Yamamoto, Kazuhiko; Harigai, Masayoshi; Ishida, Kota; Miyasaka, Nobuyuki

2014-01-01

A post-marketing surveillance (PMS) program was implemented to assess the safety and effectiveness of tacrolimus (TAC) in Japanese rheumatoid arthritis (RA) patients and to identify risk factors related to adverse drug reactions (ADRs). Patients were registered centrally and monitored for all adverse events (AEs) for 24 weeks. Effectiveness was evaluated using the Disease Activity Score 28-CRP (DAS28-CRP). Data from 3,172 patients (mean age 62.2 years) were evaluated in the safety analysis. Of the safety population, 78.5 %were female and 25.9 % were in Steinbrocker's functional class 3 or 4. TAC was prescribed as monotherapy in 52.5 % and the most common concomitant disease modifying antirheumatic drug (DMARD) was methotrexate, used in 28.9 % of the patients. The incidence of AEs, serious AEs (SAEs), ADRs and serious ADRs were 41.2, 6.4, 36.0, and 4.9 %, respectively. The most frequent serious ADR category was infections and infestations. Age ≥ 65 years, concurrent renal dysfunction, and concurrent diabetes mellitus were identified as significant risk factors for ADR. Based on EULAR response criteria, 65.4 % of the patients showed moderate or good response. The results demonstrate that TAC is well tolerated by Japanese patients with active RA, including those receiving concomitant methotrexate, in the real world.

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.

Tetanus Surveillance

MedlinePlus

... Links Tetanus Vaccination Maternal and Neonatal Tetanus Elimination Surveillance Recommend on Facebook Tweet Share Compartir Reported tetanus ... date on their 10-year booster shots. National surveillance for tetanus is monitored by the National Notifiable ...

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.

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…

A new source of data for public health surveillance: Facebook likes.

PubMed

Gittelman, Steven; Lange, Victor; Gotway Crawford, Carol A; Okoro, Catherine A; Lieb, Eugene; Dhingra, Satvinder S; Trimarchi, Elaine

2015-04-20

Investigation into personal health has become focused on conditions at an increasingly local level, while response rates have declined and complicated the process of collecting data at an individual level. Simultaneously, social media data have exploded in availability and have been shown to correlate with the prevalence of certain health conditions. Facebook likes may be a source of digital data that can complement traditional public health surveillance systems and provide data at a local level. We explored the use of Facebook likes as potential predictors of health outcomes and their behavioral determinants. We performed principal components and regression analyses to examine the predictive qualities of Facebook likes with regard to mortality, diseases, and lifestyle behaviors in 214 counties across the United States and 61 of 67 counties in Florida. These results were compared with those obtainable from a demographic model. Health data were obtained from both the 2010 and 2011 Behavioral Risk Factor Surveillance System (BRFSS) and mortality data were obtained from the National Vital Statistics System. Facebook likes added significant value in predicting most examined health outcomes and behaviors even when controlling for age, race, and socioeconomic status, with model fit improvements (adjusted R(2)) of an average of 58% across models for 13 different health-related metrics over basic sociodemographic models. Small area data were not available in sufficient abundance to test the accuracy of the model in estimating health conditions in less populated markets, but initial analysis using data from Florida showed a strong model fit for obesity data (adjusted R(2)=.77). Facebook likes provide estimates for examined health outcomes and health behaviors that are comparable to those obtained from the BRFSS. Online sources may provide more reliable, timely, and cost-effective county-level data than that obtainable from traditional public health surveillance systems as

Surveillance for Chikungunya and Dengue During the First Year of Chikungunya Virus Circulation in Puerto Rico

PubMed Central

Sharp, Tyler M.; Ryff, Kyle R.; Alvarado, Luisa; Shieh, Wun-Ju; Zaki, Sherif R.; Margolis, Harold S.; Rivera-Garcia, Brenda

2016-01-01

After chikungunya virus (CHIKV) transmission was detected in Puerto Rico in May 2014, multiple surveillance systems were used to describe epidemiologic trends and CHIKV-associated disease. Of 28 327 cases reported via passive surveillance, 6472 were tested for evidence of CHIKV infection, and results for 4399 (68%) were positive. Of 250 participants in household cluster investigations, 70 (28%) had evidence of recent CHIKV infection. Enhanced surveillance for chikungunya at 2 hospitals identified 1566 patients who tested positive for CHIKV, of whom 10.9% were hospitalized. Enhanced surveillance for fatal cases enabled identification of 31 cases in which CHIKV was detected in blood or tissue specimens. All surveillance systems detected a peak incidence of chikungunya in September 2014 and continued circulation in 2015. Concomitant surveillance for dengue demonstrated low incidence, which had decreased before CHIKV was introduced. Multifaceted chikungunya surveillance in Puerto Rico resolved gaps in traditional passive surveillance and enabled a holistic description of the spectrum of disease associated with CHIKV infection. PMID:27920177

Safety and Efficacy of Teneligliptin in Patients with Type 2 Diabetes Mellitus and Impaired Renal Function: Interim Report from Post-marketing Surveillance.

PubMed

Haneda, Masakazu; Kadowaki, Takashi; Ito, Hiroshi; Sasaki, Kazuyo; Hiraide, Sonoe; Ishii, Manabu; Matsukawa, Miyuki; Ueno, Makoto

2018-06-01

Teneligliptin is a novel oral dipeptidyl peptidase-4 inhibitor for the treatment of type 2 diabetes mellitus (T2DM). Safety and efficacy of teneligliptin have been demonstrated in clinical studies; however, data supporting its use in patients with moderate or severe renal impairment are limited. This interim analysis of a post-marketing surveillance of teneligliptin, exploRing the long-term efficacy and safety included cardiovascUlar events in patients with type 2 diaBetes treated bY teneligliptin in the real-world (RUBY), aims to verify the long-term safety and efficacy of teneligliptin in Japanese patients with T2DM and impaired renal function. For this analysis, we used the data from case report forms of the RUBY surveillance between May 2013 and June 2017. The patients were classified into G1-G5 stages of chronic kidney disease according to estimated glomerular filtration rate (eGFR) at initiation of teneligliptin treatment. Safety and efficacy were evaluated in these subgroups. Patients on dialysis were also assessed. Safety was assessed from adverse drug reactions (ADRs). Glycemic control was evaluated up to 2 years after teneligliptin initiation. A total of 11,677 patients were enrolled in the surveillance and 11,425 patient case-report forms were collected for the interim analysis. The incidence of ADRs in each subgroup was 2.98-6.98% of patients, with no differences in the ADR profile (including hypoglycemia and renal function ADRs) between subgroups. At 1 and 2 years after starting teneligliptin, the least-squares mean change in HbA1c adjusted to the baseline was - 0.68 to - 0.85% and - 0.71 to - 0.85% across the eGFR groups, respectively. Treatment with teneligliptin in patients on dialysis reduced or tended to reduce glycated albumin levels [- 2.29%, (p < 0.001) after 1 year; - 1.64%, (p = 0.064) after 2 years]. During long-term treatment, teneligliptin was generally well tolerated in patients with any stage of renal impairment from

Present status of metrology of electro-optical surveillance systems

NASA Astrophysics Data System (ADS)

Chrzanowski, K.

2017-10-01

There has been a significant progress in equipment for testing electro-optical surveillance systems over the last decade. Modern test systems are increasingly computerized, employ advanced image processing and offer software support in measurement process. However, one great challenge, in form of relative low accuracy, still remains not solved. It is quite common that different test stations, when testing the same device, produce different results. It can even happen that two testing teams, while working on the same test station, with the same tested device, produce different results. Rapid growth of electro-optical technology, poor standardization, limited metrology infrastructure, subjective nature of some measurements, fundamental limitations from laws of physics, tendering rules and advances in artificial intelligence are major factors responsible for such situation. Regardless, next decade should bring significant improvements, since improvement in measurement accuracy is needed to sustain fast growth of electro-optical surveillance technology.

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

Survey of Clostridium difficile infection surveillance systems in Europe, 2011.

PubMed

Kola, Axel; Wiuff, Camilla; Akerlund, Thomas; van Benthem, Birgit H; Coignard, Bruno; Lyytikäinen, Outi; Weitzel-Kage, Doris; Suetens, Carl; Wilcox, Mark H; Kuijper, Ed J; Gastmeier, Petra

2016-07-21

To develop a European surveillance protocol for Clostridium difficile infection (CDI), existing national CDI surveillance systems were assessed in 2011. A web-based electronic form was provided for all national coordinators of the European CDI Surveillance Network (ECDIS-Net). Of 35 national coordinators approached, 33 from 31 European countries replied. Surveillance of CDI was in place in 14 of the 31 countries, comprising 18 different nationwide systems. Three of 14 countries with CDI surveillance used public health notification of cases as the route of reporting, and in another three, reporting was limited to public health notification of cases of severe CDI. The CDI definitions published by the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) and the European Centre for Disease Prevention and Control (ECDC) were widely used, but there were differing definitions to distinguish between community- and healthcare-associated cases. All CDI surveillance systems except one reported annual national CDI rates (calculated as number of cases per patient-days). Only four surveillance systems regularly integrated microbiological data (typing and susceptibility testing results). Surveillance methods varied considerably between countries, which emphasises the need for a harmonised European protocol to allow consistent monitoring of the CDI epidemiology at European level. The results of this survey were used to develop a harmonised EU-wide hospital-based CDI surveillance protocol. This article is copyright of The Authors, 2016.

Reducing Food Insecurity and Improving Fruit and Vegetable Intake Among Farmers' Market Incentive Program Participants.

PubMed

Savoie-Roskos, Mateja; Durward, Carrie; Jeweks, Melanie; LeBlanc, Heidi

2016-01-01

To determine whether participation in a farmers' market incentive pilot program had an impact on food security and fruit and vegetable (F&V) intake of participants. Participants in the Supplemental Nutrition Assistance Program were eligible to receive a dollar-per-dollar match up to $10/wk in farmers' market incentives. The researchers used a pretest-posttest design to measure F&V intake and food security status of 54 adult participants before and after receiving farmers' market incentives. The 6-item Behavior Risk Factor Surveillance System questionnaire and US Household Food Security Survey Module were used to measure F&V intake and food security, respectively. Wilcoxon signed-rank test was used to compare scores of F&V intake. After receiving incentives, fewer individuals reported experiencing food insecurity-related behaviors. A significantly increased intake (P < .05) was found among selected vegetables. Participation in a farmers' market incentive program was positively related to greater food security and intake of select vegetables among participants in the Supplemental Nutrition Assistance Program. Copyright © 2016 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.

Security surveillance challenges and proven thermal imaging capabilities in real-world applications

NASA Astrophysics Data System (ADS)

Francisco, Glen L.; Roberts, Sharon

2004-09-01

Uncooled thermal imaging was first introduced to the public in early 1980's by Raytheon (legacy Texas Instruments Defense Segment Electronics Group) as a solution for military applications. Since the introduction of this technology, Raytheon has remained the leader in this market as well as introduced commercial versions of thermal imaging products specifically designed for security, law enforcement, fire fighting, automotive and industrial uses. Today, low cost thermal imaging for commercial use in security applications is a reality. Organizations of all types have begun to understand the advantages of using thermal imaging as a means to solve common surveillance problems where other popular technologies fall short. Thermal imaging has proven to be a successful solution for common security needs such as: ¸ vision at night where lighting is undesired and 24x7 surveillance is needed ¸ surveillance over waterways, lakes and ports where water and lighting options are impractical ¸ surveillance through challenging weather conditions where other technologies will be challenged by atmospheric particulates ¸ low maintenance requirements due to remote or difficult locations ¸ low cost over life of product Thermal imaging is now a common addition to the integrated security package. Companies are relying on thermal imaging for specific applications where no other technology can perform.

Medication sales and syndromic surveillance, France.

PubMed

Vergu, Elisabeta; Grais, Rebecca F; Sarter, Hélène; Fagot, Jean-Paul; Lambert, Bruno; Valleron, Alain-Jaques; Flahault, Antoine

2006-03-01

Although syndromic surveillance systems using nonclinical data have been implemented in the United States, the approach has yet to be tested in France. We present the results of the first model based on drug sales that detects the onset of influenza season and forecasts its trend. Using weekly lagged sales of a selected set of medications, we forecast influenzalike illness (ILI) incidence at the national and regional level for 3 epidemic seasons (2000-01, 2001-02, and 2002-03) and validate the model with real-time updating on the fourth (2003-04). For national forecasts 1-3 weeks ahead, the correlation between observed ILI incidence and forecast was 0.85-0.96, an improvement over the current surveillance method in France. Our findings indicate that drug sales are a useful additional tool to syndromic surveillance, a complementary and independent source of information, and a potential improvement for early warning systems for both epidemic and pandemic planning.

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

PubMed

Polisena, Julie; Forster, Alan J; Cimon, Karen; Rabb, Danielle

2013-10-10

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. 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. 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. 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.

Immune trypanolysis test with blood spotted on filter paper for epidemiological surveillance of sleeping sickness.

PubMed

Camara, Oumou; Camara, Mamadou; Lejon, Veerle; Ilboudo, Hamidou; Sakande, Hassane; Léno, Mamadou; Büscher, Philippe; Bucheton, Bruno; Jamonneau, Vincent

2014-07-01

The immune trypanolysis test (TL) is an accurate sero-diagnostic tool increasingly implemented for sleeping sickness medical surveillance, but it is restricted to the reference laboratories. To facilitate storage and transport of the test specimen, we developed a protocol for the examination of blood spotted on filter paper (TL-fp) that can be stored and shipped at ambient temperature. We compared its performance with the classical TL on plasma (TL-pl) that needs to be kept frozen until use. The study was conducted in active foci of the Republic of Guinea. In total, 438 specimens from treated and untreated sleeping sickness patients and serological suspects were tested with both methods. TL-fp gave significantly less positive results than TL-pl, but all the confirmed sleeping sickness cases were positive with the TL-fp protocol. TL-fp appears to offer a good compromise between feasibility and sensitivity to detect currently infected subjects who play a role in the transmission of Trypanosoma brucei gambiense and is useful for contributing to the elimination of gambiense sleeping sickness. © 2014 John Wiley & Sons Ltd.

A Population Health Surveillance Theory

PubMed Central

Bigras-Poulin, Michel; Michel, Pascal; Ravel, André

2012-01-01

OBJECTIVES Despite its extensive use, the term "Surveillance" often takes on various meanings in the scientific literature pertinent to public health and animal health. A critical appraisal of this literature also reveals ambiguities relating to the scope and necessary structural components underpinning the surveillance process. The authors hypothesized that these inconsistencies translate to real or perceived deficiencies in the conceptual framework of population health surveillance. This paper presents a population health surveillance theory framed upon an explicit conceptual system relative to health surveillance performed in human and animal populations. METHODS The population health surveillance theory reflects the authors' system of thinking and was based on a creative process. RESULTS Population health surveillance includes two broad components: one relating to the human organization (which includes expertise and the administrative program), and one relating to the system per se (which includes elements of design and method) and which can be viewed as a process. The population health surveillance process is made of five sequential interrelated steps: 1) a trigger or need, 2) problem formulation, 3) surveillance planning, 4) surveillance implementation, and 5) information communication and audit. CONCLUSIONS The population health surveillance theory provides a systematic way of understanding, organizing and evaluating the population health surveillance process. PMID:23251837

Description and validation of a new automated surveillance system for Clostridium difficile in Denmark.

PubMed

Chaine, M; Gubbels, S; Voldstedlund, M; Kristensen, B; Nielsen, J; Andersen, L P; Ellermann-Eriksen, S; Engberg, J; Holm, A; Olesen, B; Schønheyder, H C; Østergaard, C; Ethelberg, S; Mølbak, K

2017-09-01

The surveillance of Clostridium difficile (CD) in Denmark consists of laboratory based data from Departments of Clinical Microbiology (DCMs) sent to the National Registry of Enteric Pathogens (NREP). We validated a new surveillance system for CD based on the Danish Microbiology Database (MiBa). MiBa automatically collects microbiological test results from all Danish DCMs. We built an algorithm to identify positive test results for CD recorded in MiBa. A CD case was defined as a person with a positive culture for CD or PCR detection of toxin A and/or B and/or binary toxin. We compared CD cases identified through the MiBa-based surveillance with those reported to NREP and locally in five DCMs representing different Danish regions. During 2010-2014, NREP reported 13 896 CD cases, and the MiBa-based surveillance 21 252 CD cases. There was a 99·9% concordance between the local datasets and the MiBa-based surveillance. Surveillance based on MiBa was superior to the current surveillance system, and the findings show that the number of CD cases in Denmark hitherto has been under-reported. There were only minor differences between local data and the MiBa-based surveillance, showing the completeness and validity of CD data in MiBa. This nationwide electronic system can greatly strengthen surveillance and research in various applications.

DoD Global Emerging Infections Surveillance & Response System (DoD-GEIS). Global Influenza Surveillance Efforts

DTIC Science & Technology

2007-01-08

DoD Global Emerging Infections Surveillance & Response System (DoD-GEIS) Global Influenza Surveillance Efforts 8 January 2007 COL (Ret.) Jose L...SUBTITLE DoD Global Emerging Infections Surveillance & Response System (DoD-GEIS) Global Influenza Surveillance Efforts 5a. CONTRACT NUMBER 5b. GRANT...PAGE unclassified Standard Form 298 (Rev. 8-98) Prescribed by ANSI Std Z39-18 Lab-Based Influenza Surveillance • Sentinel Surveillance • Air Force

Testing for unit root bilinearity in the Brazilian stock market

NASA Astrophysics Data System (ADS)

Tabak, Benjamin M.

2007-11-01

In this paper a simple test for detecting bilinearity in a stochastic unit root process is used to test for the presence of nonlinear unit roots in Brazilian equity shares. The empirical evidence for a set of 53 individual stocks, after adjusting for GARCH effects, suggests that for more than 66%, the hypothesis of unit root bilinearity is accepted. Therefore, the dynamics of Brazilian share prices is in conformity with this type of nonlinearity. These nonlinearities in spot prices may emerge due to the sophistication of the derivatives market.

[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

Testing for multifractality of Islamic stock markets

NASA Astrophysics Data System (ADS)

Saâdaoui, Foued

2018-04-01

Studying the power-law scaling of financial time series is a promising area of econophysics, which has often contributed to the understanding of the intricate features of the global markets. In this article, we examine the multifractality of some financial processes and the underlying formation mechanisms in the context of Islamic equity markets. The well-known Multifractal Detrended Fluctuation Analysis (MF-DFA) is used to investigate the self-similar properties of two Dow Jones Islamic Market Indexes (DJIM). The results prove that both indexes exhibit multifractal properties. By discussing the sources of multifractality, we find that they are related to the occurrence of extreme events, long-range dependency of autocorrelations and fat-tailed distribution of returns. These results have several important implications for analysts and decision makers in modeling the dynamics of Islamic markets, thus recommending efficient asset allocation plans to investors dealing with Islamic equity markets.

Surveillance for Hepatocellular Carcinoma Reduces Mortality: an Inverse Probability of Treatment Weighted Analysis.

PubMed

Chaiteerakij, Roongruedee; Chattieng, Piyanat; Choi, Jonggi; Pinchareon, Nutcha; Thanapirom, Kessirin; Geratikornsupuk, Nopavut

Evidence supporting benefit of hepatocellular carcinoma (HCC) surveillance in reducing mortality is not well-established. The effect of HCC surveillance in reducing mortality was assessed by an inverse probability of treatment weighting (IPTW)-based analysis controlled for inherent bias and confounders in observational studies. This retrospective cohort study was conducted on 446 patients diagnosed with HCC between 2007 and 2013 at a major referral center. Surveillance was defined as having at least 1 ultrasound test within a year before HCC diagnosis. Primary outcome was survival estimated using the Kaplan-Meier method with lead-time bias adjustment and compared using the log-rank test. Hazard ratio (HR) and 95% confidence interval (CI) were computed using conventional Cox and weighted Cox proportional hazards analysis with IPTW adjustment. Of the 446 patients, 103 (23.1%) were diagnosed with HCC through surveillance. The surveillance group had more patients with the Barcelona-Clinic Liver Cancer stage A (80.6% vs. 33.8%, P < 0.0001), more patients eligible for potentially curative treatment (73.8% vs. 44.9%, P < 0.0001), and longer median survival (49.6 vs. 15.9 months, P < 0.0001). By conventional multivariate Cox analysis, HR (95% CI) of surveillance was 0.63 (0.45-0.87), P = 0.005. The estimated effect of surveillance remained similar in the IPTW-adjusted Cox analysis (HR: 0.57; 95% CI: 0.43-0.76, P < 0.001). HCC surveillance by ultrasound is associated with a 37% reduction in mortality. Even though surveillance is recommended in all guidelines, but in practice, it is underutilized. Interventions are needed to increase surveillance rate for improving HCC outcome.

Integrated cluster- and case-based surveillance for detecting stage III zoonotic pathogens: an example of Nipah virus surveillance in Bangladesh.

PubMed

Naser, A M; Hossain, M J; Sazzad, H M S; Homaira, N; Gurley, E S; Podder, G; Afroj, S; Banu, S; Rollin, P E; Daszak, P; Ahmed, B-N; Rahman, M; Luby, S P

2015-07-01

This paper explores the utility of cluster- and case-based surveillance established in government hospitals in Bangladesh to detect Nipah virus, a stage III zoonotic pathogen. Physicians listed meningo-encephalitis cases in the 10 surveillance hospitals and identified a cluster when ⩾2 cases who lived within 30 min walking distance of one another developed symptoms within 3 weeks of each other. Physicians collected blood samples from the clustered cases. As part of case-based surveillance, blood was collected from all listed meningo-encephalitis cases in three hospitals during the Nipah season (January-March). An investigation team visited clustered cases' communities to collect epidemiological information and blood from the living cases. We tested serum using Nipah-specific IgM ELISA. Up to September 2011, in 5887 listed cases, we identified 62 clusters comprising 176 encephalitis cases. We collected blood from 127 of these cases. In 10 clusters, we identified a total of 62 Nipah cases: 18 laboratory-confirmed and 34 probable. We identified person-to-person transmission of Nipah virus in four clusters. From case-based surveillance, we identified 23 (4%) Nipah cases. Faced with thousands of encephalitis cases, integrated cluster surveillance allows targeted deployment of investigative resources to detect outbreaks by stage III zoonotic pathogens in resource-limited settings.

[National Antimicrobial Resistance Surveillance System (NAMRSS) external quality assessment studies: 2011-2016].

PubMed

Süzük Yıldız, Serap; Şimşek, Hüsniye; Çöplü, Nilay; Gülay, Zeynep

2017-07-01

Establishment of sustainable and evidence-based surveillance systems are recommended for prevention of microbial resistance by the World Health Organization (WHO). As a necessity of these surveillance systems, participants are recommended to implement an external quality assessment (EQA) program. In this scope, National Antimicrobial Resistance Surveillance System (NARSS) has been established within the Public Health Institute of Turkey (PHIT) in our country since 2011. In the scope of this surveillance, NARSS EQA program has been implemented in a cycle per year and four isolates were sent to participants per cycle every year since 2011. In this study, it was aimed to evaluate the six years results of the EQA programs being implemented on NARSS participants between 2011 and 2016. The surveillance system consisted of 118 laboratories. Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Staphylococcus aureus, Streptococcus pneumoniae, Enterococcus faecium/faecalis and Acinetobacter baumannii bacteria included in scope of the surveillance were sent to participants. Identification of bacteria to the species level, verification of the antibiotic susceptibility test results and existence of specified resistance of the isolates performed with valid test methods required from the participants. Identified isolates were cultured with routine microbiological methods and sent to participants in ambient temperature in triple carrying pouches inside suitable carrying media via PTT Cargo. The results were entered by means of passwords prepared by PHIT and sent to the web based system. The analysis of results were made with SPSS program. A total of twenty-three isolates were sent to participants between 2011 and 2016. It was determined that participants commonly preferred automated systems for bacterial identification and antibiotic sensitivity test results. The use of MALDI TOF MS system was determined to be raised up to 15.65% in 2016. It has been determined that

Trends in Animal Rabies Surveillance in the Endemic State of Minas Gerais, Brazil

PubMed Central

Oviedo-Pastrana, Misael E.; Oliveira, Camila S. F.; Capanema, Renato O.; Nicolino, Rafael R.; Oviedo-Socarras, Teresa J.; Haddad, João Paulo A.

2015-01-01

Rabies is a viral zoonosis affecting mammal species and causes large economic losses. Included among the neglected diseases, it is still insufficiently addressed by governments and the international community, despite formal surveillance and control programs. This study used a dataset of 10,112 rabies diagnoses in animals provided by the Brazilian passive surveillance system from 2001 to 2012. The positivity rate of the tested samples was 26.4%, and a reduction in the total samples sent during the last six years was observed. The kernel density map indicated case concentration in the south region and a decrease in density of rabies cases in the second period studied (2007 to 2012). The directional trend of positive rabies diagnoses remained in the south region, as shown by the standard deviational ellipse. The spatial scan statistic identified three large clusters of positive diagnoses, one in the first period (2001-2006) and two in the second period (2007-2012), indicating an expansion of risk areas. The decrease in rabies cases from 2006 to 2012 does not necessarily reflect lower viral circulation or improvement in actions by epidemiological surveillance; this decrease could indicate a deficiency in epidemiological surveillance during the observation period due to the increase in the silent areas. Surveillance should maintain an increasing or constant number of tests during the years in addition to a reduction in the number of outbreaks of rabies, which would indicate a lower positivity rate. The findings in this study indicate deterioration in the effectiveness of the passive surveillance for rabies. The number of rabies cases, total number of tests performed and positivity rate are good indicators for evaluating passive surveillance. This paper can function as a guide for the assessment and improvement of the actions in passive surveillance of rabies. PMID:25774775

Drug-induced lung injury associated with sorafenib: analysis of all-patient post-marketing surveillance in Japan.

PubMed

Horiuchi-Yamamoto, Yuka; Gemma, Akihiko; Taniguchi, Hiroyuki; Inoue, Yoshikazu; Sakai, Fumikazu; Johkoh, Takeshi; Fujimoto, Kiminori; Kudoh, Shoji

2013-08-01

Sorafenib is a multi-kinase inhibitor currently approved in Japan for unresectable and/or metastatic renal cell carcinoma and unresectable hepatocellular carcinoma. Although drug-induced lung injury has recently been the focus of interest in Japanese patients treated with molecular targeting agents, the clinical features of patients receiving sorafenib remain to be completely investigated. All-patient post-marketing surveillance data was obtained within the frame of Special Drug Use Investigation; between April 2008 and March 2011, we summarized the clinical information of 62 cases with drug-induced lung injury among approximately 13,600 sorafenib-treated patients in Japan. In addition, we summarized the results of evaluation by a safety board of Japanese experts in 34 patients in whom pulmonary images were available. For the calculation of reporting frequency, interim results of Special Drug Use Investigation were used. In the sets of completed reports (2,407 in renal cell carcinoma and 647 in hepatocellular carcinoma), the reporting frequency was 0.33 % (8 patients; fatal, 4/8) and 0.62 % (4 patients; fatal, 2/4), respectively. Major clinical symptoms included dyspnea, cough, and fever. Evaluation of the images showed that 18 cases out of 34 patients had a pattern of diffuse alveolar damage. The patients with hepatocellular carcinoma showed a greater incidence and earlier onset of lung injury than those with renal cell carcinoma. Although the overall reporting frequency of sorafenib-induced lung injury is not considered high, the radiological diffuse alveolar damage pattern led to a fatal outcome. Therefore, early recognition of sorafenib-induced lung injury is crucial for physicians and patients.

Internet little cigar and cigarillo vendors: Surveillance of sales and marketing practices via website content analysis.

PubMed

Williams, Rebecca S; Derrick, Jason C

2018-04-01

Cigar sales have nearly doubled as cigarette sales have dropped, and large cigars have been replaced by little cigars and cigarillos (LCCs). Many LCCs are flavored, are perceived as less harmful than cigarettes, and have become increasingly available from e-commerce sources. We conducted surveillance of the online retail environment in 2013 and 2014 for LCCs in order to describe characteristics of Internet tobacco vendors selling LCCs and their sales and marketing practices, youth access practices, and their practices in relation to cigarette and other tobacco product sales. In 2013, we identified and manually screened 32,446 websites, yielding 500 unique Internet LCC vendors. In 2014, we identified 511 vendors selling LCCs from a list of 31,239 manually screened websites. We then selected 249 in 2013 and 263 in 2014 for content analysis focusing on six domains including demographics, youth access, payment and delivery, products for sale, promotions and claims, and prices. Just over half of vendors in both years were located solely in the U.S. with 70.1% of those selling flavored LCCs in 2013 and 76.1% in 2014. Nearly half only used proven ineffective age verification strategies and another 10% made no attempts to verify age at all. Most vendors accepted credit cards and advertised using the United States Postal Service. Half of vendors featured a variety of health warnings and most featured promotions. Federal bans on flavored cigarettes and restrictions on age verification, payment, and shipping for Internet tobacco sales should be extended to include LCCs. Copyright © 2018 Elsevier Inc. All rights reserved.

Evaluating surveillance indicators supporting the Global Polio Eradication Initiative, 2011-2012.

PubMed

2013-04-12

The Global Polio Eradication Initiative (GPEI) was established in 1988 by the World Health Assembly to interrupt transmission of wild poliovirus (WPV); completion of this initiative was declared a programmatic emergency of public health in January 2012. Polio cases are detected through surveillance for acute flaccid paralysis (AFP) with linked stool specimens tested for polioviruses (PVs) at accredited laboratories within the Global Polio Laboratory Network (GPLN). AFP surveillance findings are supplemented by testing sewage samples (environmental surveillance) collected at selected sites. Virologic data guide where targeted immunization activities should be conducted or improved. Key performance indicators are used to 1) monitor AFP surveillance quality at national and subnational levels to identify gaps where PV transmission could occur undetected; 2) provide evidence of where PV circulation has been interrupted; and 3) allow timely detection of an outbreak. Standardized surveillance indicators allow progress to be monitored over time and compared among countries. This report presents AFP surveillance performance indicators at national and subnational levels for countries affected by polio during 2011-2012, and trends in environmental surveillance, updating previous reports. In the 19 countries with transmission of PV (WPV and/or circulating vaccine-derived poliovirus [cVDPV]) during 2011-2012, national performance indicator targets were met in 12 (63%) countries in 2011 and 13 (68%) countries in 2012. Seven countries (37%) in 2011 had ≥80% of the population living in areas meeting performance indicators, increasing to nine countries (47%) in 2012. Performance indicators for timely reporting of PV isolation and characterization were met in four of six World Health Organization (WHO) regions in 2011 and five regions in 2012. To achieve global polio eradication, efforts are needed to improve and maintain AFP surveillance and laboratory performance.

The rationale for integrated childhood meningoencephalitis surveillance: a case study from Cambodia

PubMed Central

Touch, Sok; Hills, Susan; Rani, Manju; Samnang, Chham; Khalakdina, Asheena; Jacobson, Julie

2009-01-01

Abstract Problem Recent progress in vaccine availability and affordability has raised prospects for reducing death and disability from neurological infections in children. In many Asian countries, however, the epidemiology and public health burden of neurological diseases such as Japanese encephalitis and bacterial meningitis are poorly understood. Approach A sentinel surveillance system for Japanese encephalitis was developed and embedded within the routine meningoencephalitis syndromic surveillance system in Cambodia in 2006. The sentinel surveillance system was designed so surveillance and laboratory testing for other etiologies of neurological infection could be incorporated. Local setting The Communicable Disease Control department of the Ministry of Health in Cambodia worked with partners to establish the sentinel surveillance system. Relevant changes The sentinel surveillance system has provided important information on the disease burden of Japanese encephalitis in Cambodia and is now providing a platform for expansion to incorporate laboratory testing for other vaccine-preventable neurological infections in children. Lessons learned Sentinel surveillance systems, when linked to syndromic reporting systems, can characterize the epidemiology of meningoencephalitis and identify the proportion of hospital-based neurological infection in children that is vaccine preventable. Integrated systems enable consistency in data collection, analysis and information dissemination, and they enhance the capacity of public health managers to provide more credible and integrated information to policy-makers. This will assist decision-making about the potential role of immunization in reducing the incidence of childhood neurological infections. PMID:19551241

Testing the effectiveness of deregulation in the electric utility industry: A market-based approach

NASA Astrophysics Data System (ADS)

Wang, Manfen

In this paper, I investigate one stated purpose of deregulation in the electric utility industry---to make utility operations more responsive to news releases, a proxy for market forces. My premise is that utilities providing electricity to highly deregulated states will be more responsive to market forces than those providing electricity to non-deregulated states. I employ intraday data from April to June 2001, the year after deregulation, and from 1994, the year before deregulation. I also employ the Brown-Forsythe-Modified Levene (BFL) test to determine the volatility differences between days with released news and days without released news. The results of BFL F tests for the year 2001 indicate that utilities headquartered in and serving states that have undergone substantial deregulation respond to news releases more strongly than those utilities headquartered in and serving states that are still regulated. The BFL F tests for utilities in 1994 confirm the premise that regulated utilities are less responsive to news releases. Finally, I conduct regression tests for utilities, the results of which support the findings from BFL tests---that all utilities serving highly deregulated states show pronounced responses to macroeconomic news releases. It appears that deregulation in the electric utility industry does, in fact, make utility operations more responsive to market forces and that deregulation is effective for states that implement a customer-choice model.

The role of diagnostic laboratories in support of animal disease surveillance systems.

PubMed

Zepeda, C

2007-01-01

Diagnostic laboratories are an essential component of animal disease surveillance systems. To understand the occurrence of disease in populations, surveillance systems rely on random or targeted surveys using three approaches: clinical, serological and virological surveillance. Clinical surveillance is the basis for early detection of disease and is usually centered on the detection of syndromes and clinical findings requiring confirmation by diagnostic laboratories. Although most of the tests applied usually perform to an acceptable standard, several have not been properly validated in terms of their diagnostic sensitivity and specificity. Sensitivity and specificity estimates can vary according to local conditions and, ideally, should be determined by national laboratories where the tests are to be applied. The importance of sensitivity and specificity estimates in the design and interpretation of statistically based surveys and risk analysis is fundamental to establish appropriate disease control and prevention strategies. The World Organisation for Animal Health's (OIE) network of reference laboratories acts as centers of expertise for the diagnosis of OIE listed diseases and have a role in promoting the validation of OIE prescribed tests for international trade. This paper discusses the importance of the epidemiological evaluation of diagnostic tests and the role of the OIE Reference Laboratories and Collaborating Centres in this process.

Clinical safety and efficacy of "filgrastim biosimilar 2" in Japanese patients in a post-marketing surveillance study.

PubMed

Tamura, Kazuo; Hashimoto, Kazue; Nishikawa, Kiyohiro

2018-05-01

We conducted a post-marketing surveillance to evaluate the safety and efficacy of TKN732, approved as "filgrastim biosimilar 2", in Japanese patients who developed neutropenia in the course of cancer chemotherapy or hematopoietic stem cell transplantation. A total of 653 patients were registered during the 2-year enrollment period starting from May 2013, and 627 and 614 patients were eligible for safety and efficacy analyses of the G-CSF biosimilar, respectively. Forty-three adverse drug reactions were reported in 33 patients (5.26%). Back pain was most frequently observed and reported in 20 patients (3.19%), followed by pyrexia (1.28%) and bone pain (0.96%). Risk factors for adverse reactions identified by logistic regression analyses were younger age, presence of past medical history, and lower total dose at the onset of adverse reactions. Among the 576 cancer patients who developed Grade 2-4 neutropenia after chemotherapy, recovery to Grade 1/0 was reported in 553 patients (96%) following filgrastim biosimilar 2 treatment. The median duration of neutrophil counts below 1500/μL was 5 days. In addition, all 11 patients who underwent hematopoietic stem cell transplantation had good responses to filgrastim biosimilar 2. In conclusion, this study showed that filgrastim biosimilar 2 has a similar safety profile and comparable effects to the original G-CSF product in the real world clinical setting. Copyright © 2018 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

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.

LANL surveillance requirements management and surveillance requirements from NA-12 tasking memo

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hills, Charles R

2011-01-25

Surveillance briefing to NNSA to support a tasking memo from NA-12 on Surveillance requirements. This talk presents the process for developing surveillance requirements, discusses the LANL requirements that were issued as part of that tasking memo, and presents recommendations on Component Evaluation and Planning Committee activities for FY11.

Surveillance on A/H5N1 virus in domestic poultry and wild birds in Egypt.

PubMed

El-Zoghby, Elham F; Aly, Mona M; Nasef, Soad A; Hassan, Mohamed K; Arafa, Abdel-Satar; Selim, Abdullah A; Kholousy, Shereen G; Kilany, Walid H; Safwat, Marwa; Abdelwhab, E M; Hafez, Hafez M

2013-06-22

The endemic H5N1 high pathogenicity avian influenza virus (A/H5N1) in poultry in Egypt continues to cause heavy losses in poultry and poses a significant threat to human health. Here we describe results of A/H5N1 surveillance in domestic poultry in 2009 and wild birds in 2009-2010. Tracheal and cloacal swabs were collected from domestic poultry from 22024 commercial farms, 1435 backyards and 944 live bird markets (LBMs) as well as from 1297 wild birds representing 28 different types of migratory birds. Viral RNA was extracted from a mix of tracheal and cloacal swabs media. Matrix gene of avian influenza type A virus was detected using specific real-time reverse-transcription polymerase chain reaction (RT-qPCR) and positive samples were tested by RT-qPCR for simultaneous detection of the H5 and N1 genes. In this surveillance, A/H5N1 was detected from 0.1% (n = 23/) of examined commercial poultry farms, 10.5% (n = 151) of backyard birds and 11.4% (n = 108) of LBMs but no wild bird tested positive for A/H5N1. The virus was detected from domestic poultry year-round with higher incidence in the warmer months of summer and spring particularly in backyard birds. Outbreaks were recorded mostly in Lower Egypt where 95.7% (n = 22), 68.9% (n = 104) and 52.8% (n = 57) of positive commercial farms, backyards and LBMs were detected, respectively. Higher prevalence (56%, n = 85) was reported in backyards that had mixed chickens and waterfowl together in the same vicinity and LBMs that had waterfowl (76%, n = 82). Our findings indicated broad circulation of the endemic A/H5N1 among poultry in 2009 in Egypt. In addition, the epidemiology of A/H5N1 has changed over time with outbreaks occurring in the warmer months of the year. Backyard waterfowl may play a role as a reservoir and/or source of A/H5N1 particularly in LBMs. The virus has been established in poultry in the Nile Delta where major metropolitan areas, dense human population and poultry

Human surveillance for West Nile virus infection in Ontario in 2000

PubMed Central

Ford-Jones, E. Lee; Fearon, Margaret; Leber, Chuck; Dwight, Prabo; Myszak, Moira; Cole, Beverly; Greene, Pam Baker; Artes, Sheila; McGeer, Allison; D'Cunha, Colin; Naus, Monika

2002-01-01

Background The first reports of West Nile virus (WNV) infection in the United States in 1999 prompted Ontario to establish a surveillance protocol to monitor for the possible spread of the virus into the province. Surveillance components included evaluation of dead birds, sentinel chickens, mosquito pools and human disease. We report the results of human surveillance in 2000. Methods Between July 1 and Oct. 31, 2000, an active surveillance program was undertaken in which designated site coordinators in sentinel hospitals identified patients who met the suspect case definition (fever and fluctuating level of consciousness [encephalopathy], with or without muscle weakness). During the same period, following province-wide distribution of educational material, all other patients tested for WNV antibodies were identified through review of provincial laboratory reports (laboratory-based enhanced passive surveillance). Results Of the 60 hospitals contacted, 59 agreed to participate in the active surveillance program; 52 provided information on a regular (weekly) basis, and 7 submitted fewer than 8 reports. Thirty-six (61%) of the sentinel sites reported suspect cases. In total, 188 patients were tested (130 identified through active surveillance and 58 through enhanced passive surveillance). Patients identified through active surveillance were more likely than those identified through passive surveillance to meet the suspect case definition (43% [n = 56] v. 7% [n = 4]), to be admitted to hospital (75% [n = 99] v. 16% [n = 9]), to have a longer hospital stay (mean 25 v. 3 days), to have had a second (convalescent) serum sample collected (37% [n = 48] v. 31% [n = 18]), to have had a cerebrospinal fluid (CSF) sample banked (56% [n = 73] v. 14% [n = 8]) and to have had a discharge diagnosis reported (79% [n = 103] v. 28% [n = 16]). Of the 60 patients (32%) who met the suspect case definition, 34 (57% [31 active, 3 passive]) had a discharge diagnosis of encephalitis. Of these

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.

Surveillance for Chikungunya and Dengue During the First Year of Chikungunya Virus Circulation in Puerto Rico.

PubMed

Sharp, Tyler M; Ryff, Kyle R; Alvarado, Luisa; Shieh, Wun-Ju; Zaki, Sherif R; Margolis, Harold S; Rivera-Garcia, Brenda

2016-12-15

After chikungunya virus (CHIKV) transmission was detected in Puerto Rico in May 2014, multiple surveillance systems were used to describe epidemiologic trends and CHIKV-associated disease. Of 28 327 cases reported via passive surveillance, 6472 were tested for evidence of CHIKV infection, and results for 4399 (68%) were positive. Of 250 participants in household cluster investigations, 70 (28%) had evidence of recent CHIKV infection. Enhanced surveillance for chikungunya at 2 hospitals identified 1566 patients who tested positive for CHIKV, of whom 10.9% were hospitalized. Enhanced surveillance for fatal cases enabled identification of 31 cases in which CHIKV was detected in blood or tissue specimens. All surveillance systems detected a peak incidence of chikungunya in September 2014 and continued circulation in 2015. Concomitant surveillance for dengue demonstrated low incidence, which had decreased before CHIKV was introduced. Multifaceted chikungunya surveillance in Puerto Rico resolved gaps in traditional passive surveillance and enabled a holistic description of the spectrum of disease associated with CHIKV infection. Published by Oxford University Press for the Infectious Diseases Society of America 2016. This work is written by (a) US Government employee(s) and is in the public domain in the US.

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.

Automated Health Surveillance

PubMed Central

Block, Bruce; Brennan, J.A.

1987-01-01

A successful health maintenance program requires physicians interested in and knowledgeable about the appropriate health surveillance actions to pursue. But even well-informed physicians need help transforming good intentions into effective health surveillance. An automated health surveillance system was designed and implemented to simplify documentation of health maintenance and remind physicians when actions were overdue. The system has increased insight into the complex process of health promotion and promises to be an important clinical, educational, and research tool.

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.

Surveillance for human Salmonella infections in the United States.

PubMed

Swaminathan, Bala; Barrett, Timothy J; Fields, Patricia

2006-01-01

Surveillance for human Salmonella infections plays a critical role in understanding and controlling foodborne illness due to Salmonella. Along with its public health partners, the Centers for Disease Control and Prevention (CDC) has several surveillance systems that collect information on Salmonella infections in the United States. The National Salmonella Surveillance System, begun in 1962, receives reports of laboratory-confirmed Salmonella infections through state public health laboratories. Salmonella outbreaks are reported by state and local health departments through the Foodborne Disease Outbreak Reporting System, which became a Web-based, electronic system (eFORS) in 2001. PulseNet facilitates the detection of clusters of Salmonella infections through standardized molecular subtyping (DNA "fingerprinting") of isolates and maintenance of "fingerprint" databases. The National Antimicrobial Resistance Monitoring System for Enteric Bacteria (NARMS) monitors antimicrobial resistance in Salmonella by susceptibility testing of every 20th Salmonella isolate received by state and local public health laboratories. FootNet is an active surveillance system that monitors Salmonella infections in sentinel areas, providing population-based estimates of infection rates. Efforts are underway to electronically link all of the Salmonella surveillance systems at CDC to facilitate optimum use of available data and minimize duplication.

National addictions vigilance intervention and prevention program (NAVIPPRO): a real-time, product-specific, public health surveillance system for monitoring prescription drug abuse.

PubMed

Butler, Stephen F; Budman, Simon H; Licari, Andrea; Cassidy, Theresa A; Lioy, Katherine; Dickinson, James; Brownstein, John S; Benneyan, James C; Green, Traci Craig; Katz, Nathaniel

2008-12-01

The National Addictions Vigilance Intervention and Prevention Program (NAVIPPRO) is a scientific, comprehensive risk management program for scheduled therapeutics. NAVIPPRO provides post-marketing surveillance, signal detection, signal verification and prevention and intervention programs. Here we focus on one component of NAVIPPRO surveillance, the Addiction Severity Index-Multimedia Version (ASI-MV) Connect, a continuous, real-time, national data stream that assesses pharmaceutical abuse by patients entering substance abuse treatment by collecting product-specific, geographically-detailed information. We evaluate population characteristics for data collected through the ASI-MV Connect in 2007 and 2008 and assess the representativeness, geographic coverage, and timeliness of report of the data. Analyses based on 41,923 admissions to 265 treatment centers in 29 states were conducted on product-specific opioid abuse rates, source of drug, and route of administration. ASI-MV Connect data revealed that 11.5% of patients reported abuse of at least one opioid analgesic product in the 30 days prior to entering substance abuse treatment; differences were observed among sub-populations of prescription opioid abusers, among products, and also within various geographic locations. The ASI-MV Connect component of NAVIPPRO represents a potentially valuable data stream for post-marketing surveillance of prescription drugs. Analyses conducted with data obtained from the ASI-MV Connect allow for the characterization of product-specific and geospatial differences for drug abuse and can serve as a tool to monitor responses of the abuse population to newly developed "abuse deterrent" drug formulations. Additional data, evaluation, and comparison to other systems are important next steps in establishing NAVIPPRO as a comprehensive, post-marketing surveillance system for prescription drugs. Copyright (c) 2008 John Wiley & Sons, Ltd.

9975 SHIPPING PACKAGE LIFE EXTENSION SURVEILLANCE PROGRAM RESULTS SUMMARY

DOE Office of Scientific and Technical Information (OSTI.GOV)

Daugherty, W.; Dunn, K.; Hackney, B.

2011-01-06

Results from the 9975 Surveillance Program at the Savannah River Site (SRS) are summarized for justification to extend the life of the 9975 packages currently stored in the K-Area Materials Storage (KAMS) facility from 10 years to 15 years. This justification is established with the stipulation that surveillance activities will continue throughout this extended time to ensure the continued integrity of the 9975 materials of construction and to further understand the currently identified degradation mechanisms. The current 10 year storage life was developed prior to storage. A subsequent report was later used to extend the qualification of the 9975 shippingmore » packages for 2 years for shipping plus 10 years for storage. However the qualification for the storage period was provided by the monitoring requirements of the Storage and Surveillance Program. This report summarizes efforts to determine a new safe storage limit for the 9975 shipping package based on the surveillance data collected since 2005 when the surveillance program began. KAMS is a zero-release facility that depends upon containment by the 9975 to meet design basis storage requirements. Therefore, to confirm the continued integrity of the 9975 packages while stored in KAMS, a 9975 Storage and Surveillance Program was implemented alongside the DOE required Integrated Surveillance Program (ISP) for 3013 plutonium-bearing containers. The 9975 Storage and Surveillance Program performs field surveillance as well as accelerated aging tests to ensure any degradation due to aging, to the extent that could affect packaging performance, is detected in advance of such degradation occurring in the field. The Program has demonstrated that the 9975 package has a robust design that can perform under a variety of conditions. As such the primary emphasis of the on-going 9975 Surveillance Program is an aging study of the 9975 Viton(reg.sign) GLT containment vessel O-rings and the Celotex(reg.sign) fiberboard

A prospective, multicenter, post marketing surveillance study to evaluate the safety and effectiveness of the Superia-Sirolimus Eluting Coronary Stent System (SSECSS) implanted during routine clinical practice in India.

PubMed

Chandra, Praveen; Kumar, Tarun

2014-01-01

A prospective, multicenter, post marketing surveillance study to evaluate the safety and effectiveness of the Superia-Sirolimus Eluting Coronary Stent System (SSECSS) implanted during routine clinical practice in India. 1. To study the MACE and in stent and In-segment Loss at Six Months (in a pre selected group of 50 patients). 1. Clinical and procedural success. This is a prospective, open label, single-arm, multicenter (16 sites), post marketing observational study enrolling patients implanted with Superia-Sirolimus Eluting Coronary Stent (SSECS) in routine clinical practice in India. A total of 200 Patients of coronary Artery Disease (CAD) implanted with Superia-Sirolimus Eluting Coronary Stent (SSECS) were enrolled. Clinical assessments were done at 30 days, 180 days and at 1, 2 years either telephonically or office visit. A cohort of 50 pre-selected patients were followed up for angiographic evaluation at 180 days. MACE at 12 month of follow up was 1.71%.Late lumen loss, in segment was 0.14 and in stent was 0.10 mm at 6 month of follow-up. TLR was required only in 2 patients. Superia stent is as safe as other biodegradable polymer stent in the market and time has come for biodegradable polymer stent with thin struts. Copyright © 2014 Cardiological Society of India. Published by Elsevier B.V. All rights reserved.

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

PubMed Central

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

Background 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. Methods and Findings 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. Conclusions 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. PMID:26181042

Bovine tuberculosis surveillance in cattle and free-ranging wildlife in EU Member States in 2013: a survey-based review.

PubMed

Rivière, J; Carabin, K; Le Strat, Y; Hendrikx, P; Dufour, B

2014-10-10

Bovine tuberculosis (TB) is a common disease in cattle and wildlife, with animal health, zoonotic and economic impacts. Most of the TB data for the European Union (EU) concern the epidemiological situation, but comprehensive descriptions of the way in which surveillance is conducted in each country are rare, despite being essential for cross-Europe comparisons. A European survey was conducted in the 28 Member States and in three other neighboring countries (Norway, Macedonia and Switzerland), to review TB surveillance in cattle and wildlife. EU legislation currently requires TB surveillance solely in cattle. Considerable differences between the surveillance systems of the 26 responding countries were observed, according to the official TB-freedom status of the country and the local prevalence of TB. These differences related principally to the combination of surveillance components (routine screening test in herd and/or movement testing and/or slaughterhouse surveillance), the tests used and their interpretation, and the definition of an infected herd or animal. For wildlife TB surveillance, only 8 on 21 respondent countries have declared to have implemented passive and/or active surveillance, with marked differences concerning the species and the geographical scale of the surveillance. The choice of the combination of surveillance components depends on the national or regional epidemiological situation, the species involved in TB epidemiology and epidemiological risk factors, although various surveillance systems have been recorded for countries with similar epidemiological status. Assessments of the cost-effectiveness of each surveillance system would be useful, to confirm the advantages of implementing one or more components. Copyright © 2014 Elsevier B.V. All rights reserved.

Hepatocellular Carcinoma Surveillance Among Cirrhotic Patients With Commercial Health Insurance.

PubMed

Goldberg, David S; Valderrama, Adriana; Kamalakar, Rajesh; Sansgiry, Sujit S; Babajanyan, Svetlana; Lewis, James D

2016-03-01

To evaluate hepatocellular carcinoma (HCC) surveillance rates among commercially insured patients, and evaluate factors associated with compliance with surveillance recommendations. Most HCC occurs in patients with cirrhosis. American Association for the Study of Liver Diseases and European Association for the Study of the Liver guidelines each recommend biannual HCC surveillance for cirrhotic patients to diagnose HCC at an early, curable stage. However, compliance with these guidelines in commercially insured patients is unknown. We used the Truven Health Analytics databases from 2006 to 2010, using January 1, 2006 as the anchor date for evaluating outcomes. The primary outcome was continuous surveillance measure, defined as the proportion of time "up-to-date" with surveillance (PTUDS), with the 6-month interval immediately following each ultrasound categorized as "up-to-date." During a median follow-up of 22.9 (interquartile range, 16.3 to 33.9) months among 8916 cirrhotic patients, the mean PTUDS was 0.34 (SD, 0.29), and the median was 0.31 (interquartile range, 0.03 to 0.52). These values increased only modestly with inclusion of serum alpha-fetoprotein testing, contrast-enhanced abdominal computed tomographic scans or magnetic resonance imagings, and/or extension of up-to-date time to 12 months. Being diagnosed by a nongastroenterology provider and increasing age were significantly associated with decreased HCC surveillance (P<0.05), whereas a history of a hepatic decompensation event, presence of any component of the metabolic syndrome, and diagnosis of hepatitis B or hepatitis C were significantly associated with increased surveillance (P<0.05). However, even among patients with the most favorable characteristics, surveillance rates remained low. HCC surveillance rates in commercially insured at-risk patients remain poor despite formalized guidelines, highlighting the need to develop interventions to improve surveillance rates.

Molecular Antimicrobial Resistance Surveillance for Neisseria gonorrhoeae, Northern Territory, Australia.

PubMed

Whiley, David M; Trembizki, Ella; Buckley, Cameron; Freeman, Kevin; Baird, Robert W; Beaman, Miles; Chen, Marcus; Donovan, Basil; Kundu, Ratan L; Fairley, Christopher K; Guy, Rebecca; Hogan, Tiffany; Kaldor, John M; Karimi, Mahdad; Limnios, Athena; Regan, David G; Ryder, Nathan; Su, Jiunn-Yih; Ward, James; Lahra, Monica M

2017-09-01

Neisseria gonorrhoeae antimicrobial resistance (AMR) is a globally recognized health threat; new strategies are needed to enhance AMR surveillance. The Northern Territory of Australia is unique in that 2 different first-line therapies, based primarily on geographic location, are used for gonorrhea treatment. We tested 1,629 N. gonorrhoeae nucleic acid amplification test-positive clinical samples, collected from regions where ceftriaxone plus azithromycin or amoxicillin plus azithromycin are recommended first-line treatments, by using 8 N. gonorrhoeae AMR PCR assays. We compared results with those from routine culture-based surveillance data. PCR data confirmed an absence of ceftriaxone resistance and a low level of azithromycin resistance (0.2%), and that penicillin resistance was <5% in amoxicillin plus azithromycin regions. Rates of ciprofloxacin resistance and penicillinase-producing N. gonorrhoeae were lower when molecular methods were used. Molecular methods to detect N. gonorrhoeae AMR can increase the evidence base for treatment guidelines, particularly in settings where culture-based surveillance is limited.

Evaluating Behavioral Health Surveillance Systems.

PubMed

Azofeifa, Alejandro; Stroup, Donna F; Lyerla, Rob; Largo, Thomas; Gabella, Barbara A; Smith, C Kay; Truman, Benedict I; Brewer, Robert D; Brener, Nancy D

2018-05-10

In 2015, more than 27 million people in the United States reported that they currently used illicit drugs or misused prescription drugs, and more than 66 million reported binge drinking during the previous month. Data from public health surveillance systems on drug and alcohol abuse are crucial for developing and evaluating interventions to prevent and control such behavior. However, public health surveillance for behavioral health in the United States has been hindered by organizational issues and other factors. For example, existing guidelines for surveillance evaluation do not distinguish between data systems that characterize behavioral health problems and those that assess other public health problems (eg, infectious diseases). To address this gap in behavioral health surveillance, we present a revised framework for evaluating behavioral health surveillance systems. This system framework builds on published frameworks and incorporates additional attributes (informatics capabilities and population coverage) that we deemed necessary for evaluating behavioral health-related surveillance. This revised surveillance evaluation framework can support ongoing improvements to behavioral health surveillance systems and ensure their continued usefulness for detecting, preventing, and managing behavioral health problems.

Evaluating Behavioral Health Surveillance Systems

PubMed Central

Azofeifa, Alejandro; Lyerla, Rob; Largo, Thomas; Gabella, Barbara A.; Smith, C. Kay; Truman, Benedict I.; Brewer, Robert D.; Brener, Nancy D.

2018-01-01

In 2015, more than 27 million people in the United States reported that they currently used illicit drugs or misused prescription drugs, and more than 66 million reported binge drinking during the previous month. Data from public health surveillance systems on drug and alcohol abuse are crucial for developing and evaluating interventions to prevent and control such behavior. However, public health surveillance for behavioral health in the United States has been hindered by organizational issues and other factors. For example, existing guidelines for surveillance evaluation do not distinguish between data systems that characterize behavioral health problems and those that assess other public health problems (eg, infectious diseases). To address this gap in behavioral health surveillance, we present a revised framework for evaluating behavioral health surveillance systems. This system framework builds on published frameworks and incorporates additional attributes (informatics capabilities and population coverage) that we deemed necessary for evaluating behavioral health–related surveillance. This revised surveillance evaluation framework can support ongoing improvements to behavioral health surveillance systems and ensure their continued usefulness for detecting, preventing, and managing behavioral health problems. PMID:29752804

Evaluation of the Effectiveness and Cost-Effectiveness of Personalized Surveillance After Colorectal Adenomatous Polypectomy.

PubMed

McFerran, Ethna; O'Mahony, James F; Fallis, Richard; McVicar, Duncan; Zauber, Ann G; Kee, Frank

2017-01-01

Lifetime risk of developing colorectal cancer is 5%, and 5-year survival at early stage is 92%. Individuals with precancerous lesions removed at primary screening are typically recommended surveillance colonoscopy. Because greater benefits are anticipated for those with higher risk of colorectal cancer, scope for risk-specific surveillance recommendations exists. This review assesses published cost-effectiveness estimates of postpolypectomy surveillance to consider the potential for personalized recommendations by risk group. Meta-analyses of incidence of advanced neoplasia postpolypectomy for low-risk cases were comparable to those without adenoma, with both rates under the lifetime risk of 5%. This group may not benefit from intensive surveillance, which risks unnecessary harm and inefficient use of often scarce colonoscopy capacity. Therefore, greater personalization through deintensified strategies for low-risk individuals could be beneficial. The potential for noninvasive testing, such as fecal immunochemical tests, combined with primary prevention or chemoprevention may reserve colonoscopy for targeted use in personalized risk-stratified surveillance. This review appraised evidence supporting a program of personalized surveillance in patients with colorectal adenoma according to risk group and compared the effectiveness of surveillance colonoscopy with alternative prevention strategies. It assessed trade-offs among costs, benefits, and adverse effects that must be considered in a decision to adopt or reject personalized surveillance. © The Author 2017. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Assessing the sensitivity of bovine tuberculosis surveillance in Canada's cattle population, 2009-2013.

PubMed

El Allaki, Farouk; Harrington, Noel; Howden, Krista

2016-11-01

The objectives of this study were (1) to estimate the annual sensitivity of Canada's bTB surveillance system and its three system components (slaughter surveillance, export testing and disease investigation) using a scenario tree modelling approach, and (2) to identify key model parameters that influence the estimates of the surveillance system sensitivity (SSSe). To achieve these objectives, we designed stochastic scenario tree models for three surveillance system components included in the analysis. Demographic data, slaughter data, export testing data, and disease investigation data from 2009 to 2013 were extracted for input into the scenario trees. Sensitivity analysis was conducted to identify key influential parameters on SSSe estimates. The median annual SSSe estimates generated from the study were very high, ranging from 0.95 (95% probability interval [PI]: 0.88-0.98) to 0.97 (95% PI: 0.93-0.99). Median annual sensitivity estimates for the slaughter surveillance component ranged from 0.95 (95% PI: 0.88-0.98) to 0.97 (95% PI: 0.93-0.99). This shows that slaughter surveillance to be the major contributor to overall surveillance system sensitivity with a high probability to detect M. bovis infection if present at a prevalence of 0.00028% or greater during the study period. The export testing and disease investigation components had extremely low component sensitivity estimates-the maximum median sensitivity estimates were 0.02 (95% PI: 0.014-0.023) and 0.0061 (95% PI: 0.0056-0.0066) respectively. The three most influential input parameters on the model's output (SSSe) were the probability of a granuloma being detected at slaughter inspection, the probability of a granuloma being present in older animals (≥12 months of age), and the probability of a granuloma sample being submitted to the laboratory. Additional studies are required to reduce the levels of uncertainty and variability associated with these three parameters influencing the surveillance system

An integrated national mortality surveillance system for death registration and mortality surveillance, China.

PubMed

Liu, Shiwei; Wu, Xiaoling; Lopez, Alan D; Wang, Lijun; Cai, Yue; Page, Andrew; Yin, Peng; Liu, Yunning; Li, Yichong; Liu, Jiangmei; You, Jinling; Zhou, Maigeng

2016-01-01

In China, sample-based mortality surveillance systems, such as the Chinese Center for Disease Control and Prevention's disease surveillance points system and the Ministry of Health's vital registration system, have been used for decades to provide nationally representative data on health status for health-care decision-making and performance evaluation. However, neither system provided representative mortality and cause-of-death data at the provincial level to inform regional health service needs and policy priorities. Moreover, the systems overlapped to a considerable extent, thereby entailing a duplication of effort. In 2013, the Chinese Government combined these two systems into an integrated national mortality surveillance system to provide a provincially representative picture of total and cause-specific mortality and to accelerate the development of a comprehensive vital registration and mortality surveillance system for the whole country. This new system increased the surveillance population from 6 to 24% of the Chinese population. The number of surveillance points, each of which covered a district or county, increased from 161 to 605. To ensure representativeness at the provincial level, the 605 surveillance points were selected to cover China's 31 provinces using an iterative method involving multistage stratification that took into account the sociodemographic characteristics of the population. This paper describes the development and operation of the new national mortality surveillance system, which is expected to yield representative provincial estimates of mortality in China for the first time.

Cost distribution of bluetongue surveillance and vaccination programmes in Austria and Switzerland (2007–2016)

PubMed Central

Pinior, Beate; Loitsch, Angelika; Stockreiter, Simon; Hutter, Sabine; Richter, Veronika; Lebl, Karin; Schwermer, Heinzpeter; Käsbohrer, Annemarie

2018-01-01

Bluetongue virus (BTV) is an emerging transboundary disease in Europe, which can cause significant production losses among ruminants. The analysis presented here assessed the costs of BTV surveillance and vaccination programmes in Austria and Switzerland between 2007 and 2016. Costs were compared with respect to time, type of programme, geographical area and who was responsible for payment. The total costs of the BTV vaccination and surveillance programmes in Austria amounted to €23.6 million, whereas total costs in Switzerland were €18.3 million. Our analysis demonstrates that the costs differed between years and geographical areas, both within and between the two countries. Average surveillance costs per animal amounted to approximately €3.20 in Austria compared with €1.30 in Switzerland, whereas the average vaccination costs per animal were €6.20 in Austria and €7.40 in Switzerland. The comparability of the surveillance costs is somewhat limited, however, due to differences in each nation’s surveillance (and sampling) strategy. Given the importance of the export market for cattle production, investments in such programmes are more justified for Austria than for Switzerland. The aim of the retrospective assessment presented here is to assist veterinary authorities in planning and implementing cost-effective and efficient control strategies for emerging livestock diseases. PMID:29363572

ATIS Market Research: A Survey of Operational Tests and University and Government Research

DOT National Transportation Integrated Search

1994-03-01

This report outlines research that examines the market for Advanced Traveler Information Systems (ATIS). The report includes detailed descriptions of Pathfinder, TravTek, and SmarTraveler ATIS operational tests. It includes basic background informati...

Digital dashboard design using multiple data streams for disease surveillance with influenza surveillance as an example.

PubMed

Cheng, Calvin K Y; Ip, Dennis K M; Cowling, Benjamin J; Ho, Lai Ming; Leung, Gabriel M; Lau, Eric H Y

2011-10-14

Great strides have been made exploring and exploiting new and different sources of disease surveillance data and developing robust statistical methods for analyzing the collected data. However, there has been less research in the area of dissemination. Proper dissemination of surveillance data can facilitate the end user's taking of appropriate actions, thus maximizing the utility of effort taken from upstream of the surveillance-to-action loop. The aims of the study were to develop a generic framework for a digital dashboard incorporating features of efficient dashboard design and to demonstrate this framework by specific application to influenza surveillance in Hong Kong. Based on the merits of the national websites and principles of efficient dashboard design, we designed an automated influenza surveillance digital dashboard as a demonstration of efficient dissemination of surveillance data. We developed the system to synthesize and display multiple sources of influenza surveillance data streams in the dashboard. Different algorithms can be implemented in the dashboard for incorporating all surveillance data streams to describe the overall influenza activity. We designed and implemented an influenza surveillance dashboard that utilized self-explanatory figures to display multiple surveillance data streams in panels. Indicators for individual data streams as well as for overall influenza activity were summarized in the main page, which can be read at a glance. Data retrieval function was also incorporated to allow data sharing in standard format. The influenza surveillance dashboard serves as a template to illustrate the efficient synthesization and dissemination of multiple-source surveillance data, which may also be applied to other diseases. Surveillance data from multiple sources can be disseminated efficiently using a dashboard design that facilitates the translation of surveillance information to public health actions.

Digital Dashboard Design Using Multiple Data Streams for Disease Surveillance With Influenza Surveillance as an Example

PubMed Central

Cheng, Calvin KY; Ip, Dennis KM; Cowling, Benjamin J; Ho, Lai Ming; Leung, Gabriel M

2011-01-01

Background Great strides have been made exploring and exploiting new and different sources of disease surveillance data and developing robust statistical methods for analyzing the collected data. However, there has been less research in the area of dissemination. Proper dissemination of surveillance data can facilitate the end user's taking of appropriate actions, thus maximizing the utility of effort taken from upstream of the surveillance-to-action loop. Objective The aims of the study were to develop a generic framework for a digital dashboard incorporating features of efficient dashboard design and to demonstrate this framework by specific application to influenza surveillance in Hong Kong. Methods Based on the merits of the national websites and principles of efficient dashboard design, we designed an automated influenza surveillance digital dashboard as a demonstration of efficient dissemination of surveillance data. We developed the system to synthesize and display multiple sources of influenza surveillance data streams in the dashboard. Different algorithms can be implemented in the dashboard for incorporating all surveillance data streams to describe the overall influenza activity. Results We designed and implemented an influenza surveillance dashboard that utilized self-explanatory figures to display multiple surveillance data streams in panels. Indicators for individual data streams as well as for overall influenza activity were summarized in the main page, which can be read at a glance. Data retrieval function was also incorporated to allow data sharing in standard format. Conclusions The influenza surveillance dashboard serves as a template to illustrate the efficient synthesization and dissemination of multiple-source surveillance data, which may also be applied to other diseases. Surveillance data from multiple sources can be disseminated efficiently using a dashboard design that facilitates the translation of surveillance information to public

[Analysis on bacillary dysentery surveillance data collected from the National Surveillance System in 2007.].

PubMed

Zhong, Hao-jie; Chang, Zhao-rui; Zhang, Jing

2010-03-01

To improve the national surveillance plan on bacillary dysentery and to increase the sensitivity of the surveillance system on the disease. Data was collected through China Disease Reporting Information System (CDRIS) and National Sentinel Surveillance Sites on bacillary dysentery. Data from the CDRIS was compared with the data from the National Sentinel Surveillance to identify the exiting problems. Data from the monitoring sites showed that the detection rate of infant cases of bacillary dysentery infection was 1%, less than that of other age groups. The highest rates were seen in children aged 3 through 9 years. Rate on misdiagnosis in all age group was 23.38%, when using the surveillance case definition of clinical cases and suspect case. The rate of misdiagnosis on infant cases of bacillary dysentery infection by clinical diagnosis was 50%. It showed that Shigella flexneri and Shigella sonnei were dominant with the positive rates as 57.21% and 42.41%, respectively. From the national sentinel surveillance sites, the confirmed cases taking up 43.39% which did not match the figure from the CDRIS. The diagnostic criterion for bacillary dysentery fit well on other age groups in surveillance system except on infants. Active surveillance on bacillary dysentery that combining both clinical and laboratory diagnosis seems quite necessary on CDRIS, especially for infants.

Surveillance strategies for detecting Chronic Wasting Disease in free-ranging deer and elk: Results of a CWD surveillance workshop

USGS Publications Warehouse

Samuel, Michael D.; Joly, Damien O.; Wild, Margaret A.; Wright, Scott D.; Otis, David L.; Werge, Rob W.; Miller, Michael W.

2003-01-01

Executive SummaryChronic Wasting Disease (CWD), a fatal brain disease of North American deer and elk, has recently emerged as an important wildlife management issue. Interest and concern over the spread of this disease and its potential impact on free-ranging cervid populations has increased with discovery of the disease in numerous states and provinces. Current studies suggest that CWD may adversely affect of these highly visible, socially desirable, and economically valuable species. Despite the lack of evidence that CWD affects humans or livestock, a significant concern has been the perceived risk to humans and livestock. Uncertainty about whether CWD poses a health risk to hunters and their families who consume venison has resulted in testing of free-ranging cervids for CWD. In response to many of these concerns, wildlife management agencies across the nation have undertaken surveillance programs to detect CWD in their cervid populations. The nation-wide costs for an extensive CWD surveillance program have been estimated at several million dollars.This document provides guidance on the development and conduct of scientifically sound surveillance programs to detect CWD in free-ranging deer and elk populations. These guidelines will not apply equally to all jurisdictions. In many cases local circumstances, resources, area(s) of concern, disease risk, animal and landscape ecology, political, social, and many other factors will influence the objectives, design, and conduct of CWD surveillance programs. Part I of this report discusses the importance of management goals, strategies, and disease risks in developing a surveillance program. Part II describes surveillance methods, steps in designing a sampling strategy to detect CWD, alternative collection methods, and statistical considerations. Part III describes costs (personnel, time, and money) associated with implementation of these plans that will influence program design. Part IV outlines research that is needed

3013/9975 Surveillance Program Interim Summary Report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Dunn, K.; Hackney, B.; McClard, J.

2011-06-22

The K-Area Materials Storage (KAMS) Documented Safety Analysis (DSA) requires a surveillance program to monitor the safety performance of 3013 containers and 9975 shipping packages stored in KAMS. The SRS surveillance program [Reference 1] outlines activities for field surveillance and laboratory tests that demonstrate the packages meet the functional performance requirements described in the DSA. The SRS program also supports the complexwide Integrated Surveillance Program (ISP) [Reference 2] for 3013 containers. The purpose of this report is to provide a summary of the SRS portion of the surveillance program activities through fiscal year 2010 (FY10) and formally communicate the interpretationmore » of these results by the Surveillance Program Authority (SPA). Surveillance for the initial 3013 container random sampling of the Innocuous bin and the Pressure bin has been completed and there has been no indication of corrosion or significant pressurization. The maximum pressure observed was less than 50 psig, which is well below the design pressure of 699 psig for the 3013 container [Reference 3]. The data collected during surveillance of these bins has been evaluated by the Materials Identification and Surveillance (MIS) Working Group and no additional surveillance is necessary for these bins at least through FY13. A decision will be made whether additional surveillance of these bins is needed during future years of storage and as additional containers are generated. Based on the data collected to date, the SPA concludes that 3013 containers in these bins can continue to be safely stored in KAMS. This year, 13 destructive examinations (DE) were performed on random samples from the Pressure & Corrosion bin. To date, DE has been completed for approximately 30% of the random samples from the Pressure & Corrosion bin. In addition, DE has been performed on 6 engineering judgment (EJ) containers, for a total of 17 to date. This includes one container that exceeded the

Cost distribution of bluetongue surveillance and vaccination programmes in Austria and Switzerland (2007-2016).

PubMed

Pinior, Beate; Firth, Clair L; Loitsch, Angelika; Stockreiter, Simon; Hutter, Sabine; Richter, Veronika; Lebl, Karin; Schwermer, Heinzpeter; Käsbohrer, Annemarie

2018-03-03

Bluetongue virus (BTV) is an emerging transboundary disease in Europe, which can cause significant production losses among ruminants. The analysis presented here assessed the costs of BTV surveillance and vaccination programmes in Austria and Switzerland between 2007 and 2016. Costs were compared with respect to time, type of programme, geographical area and who was responsible for payment. The total costs of the BTV vaccination and surveillance programmes in Austria amounted to €23.6 million, whereas total costs in Switzerland were €18.3 million. Our analysis demonstrates that the costs differed between years and geographical areas, both within and between the two countries. Average surveillance costs per animal amounted to approximately €3.20 in Austria compared with €1.30 in Switzerland, whereas the average vaccination costs per animal were €6.20 in Austria and €7.40 in Switzerland. The comparability of the surveillance costs is somewhat limited, however, due to differences in each nation's surveillance (and sampling) strategy. Given the importance of the export market for cattle production, investments in such programmes are more justified for Austria than for Switzerland. The aim of the retrospective assessment presented here is to assist veterinary authorities in planning and implementing cost-effective and efficient control strategies for emerging livestock diseases. © British Veterinary Association (unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Surveillance systems to track progress toward global polio eradication - worldwide, 2012-2013.

PubMed

Levitt, Alexandra; Diop, Ousmane M; Tangermann, Rudolf H; Paladin, Fem; Kamgang, Jean Baptiste; Burns, Cara C; Chenoweth, Paul J; Goel, Ajay; Wassilak, Steven G F

2014-04-25

In 2012, the World Health Assembly of the World Health Organization (WHO) declared completion of polio eradication a programmatic emergency. Polio cases are detected through surveillance of acute flaccid paralysis (AFP) cases and subsequent testing of stool specimens for polioviruses (PVs) at WHO-accredited laboratories within the Global Polio Laboratory Network (GPLN). AFP surveillance is supplemented by environmental surveillance, testing sewage samples from selected sites for PVs. Virologic surveillance, including genomic sequencing to identify isolates by genotype and measure divergence between isolates, guides Global Polio Eradication Initiative (GPEI) activities by confirming the presence of PV, tracking chains of PV transmission, and highlighting gaps in AFP surveillance quality. This report provides AFP surveillance quality indicators at national and subnational levels during 2012-2013 for countries that experienced PV cases during 2009-2013 in the WHO African Region (AFR) and Eastern Mediterranean Region (EMR), the remaining polio-endemic regions. It also summarizes the results of environmental surveillance and reviews indicators assessing the timeliness of reporting of PV isolation and of virus strain characterization globally. Regional-level performance indicators for timely reporting of PV isolation were met in five of six WHO regions in 2012 and 2013. Of 30 AFR and EMR countries that experienced cases of PV (wild poliovirus [WPV], circulating vaccine-derived poliovirus [cVDPV], or both) during 2009-2013, national performance indicator targets for AFP surveillance and collection of adequate specimens were met in 27 (90%) countries in 2012 and 22 (73%) in 2013. In 17 (57%) countries, ≥80% of the population lived in subnational areas meeting both AFP performance indicators in 2012, decreasing to 13 (43%) in 2013. To achieve polio eradication and certify interruption of PV transmission, intensive efforts to strengthen and maintain AFP surveillance are

A New Source of Data for Public Health Surveillance: Facebook Likes

PubMed Central

Lange, Victor; Gotway Crawford, Carol A; Okoro, Catherine A; Lieb, Eugene; Dhingra, Satvinder S; Trimarchi, Elaine

2015-01-01

Background Investigation into personal health has become focused on conditions at an increasingly local level, while response rates have declined and complicated the process of collecting data at an individual level. Simultaneously, social media data have exploded in availability and have been shown to correlate with the prevalence of certain health conditions. Objective Facebook likes may be a source of digital data that can complement traditional public health surveillance systems and provide data at a local level. We explored the use of Facebook likes as potential predictors of health outcomes and their behavioral determinants. Methods We performed principal components and regression analyses to examine the predictive qualities of Facebook likes with regard to mortality, diseases, and lifestyle behaviors in 214 counties across the United States and 61 of 67 counties in Florida. These results were compared with those obtainable from a demographic model. Health data were obtained from both the 2010 and 2011 Behavioral Risk Factor Surveillance System (BRFSS) and mortality data were obtained from the National Vital Statistics System. Results Facebook likes added significant value in predicting most examined health outcomes and behaviors even when controlling for age, race, and socioeconomic status, with model fit improvements (adjusted R 2) of an average of 58% across models for 13 different health-related metrics over basic sociodemographic models. Small area data were not available in sufficient abundance to test the accuracy of the model in estimating health conditions in less populated markets, but initial analysis using data from Florida showed a strong model fit for obesity data (adjusted R 2=.77). Conclusions Facebook likes provide estimates for examined health outcomes and health behaviors that are comparable to those obtained from the BRFSS. Online sources may provide more reliable, timely, and cost-effective county-level data than that obtainable from

[Post marketing surveillance study with an analgesic (transdermal buprenorphine patch) in patients with moderate to severe chronic pain].

PubMed

Tschirner, M; Ritzdorf, I; Brünjes, R

2008-09-18

To obtain information on the efficacy, tolerability and safetyofa transdermal buprenorphine patch (Transtec PRO) in patients with moderate to severe chronic pain. In addition it should be evaluated to what extent the two fixed patch change days per weekare simplifyingthe therapy. In this prospective multi-center post marketing surveillance study patients with chronic cancer and non-cancer pain were treated with transdermal buprenorphine for up to eight weeks. The evaluation included pain intensity, the dosage of the applied analgesics and additional therapies, the renal function (by serum creatinine) and adverse events. 3654 patients were treated for a mean of 50.4 days. Using the NRS-11 the mean pain intensity decreased from 6.3 at the time when patients were switched to the transdermal buprenorphine patch to 2.6 at the last treatment evaluation. The matrix patch was safe and well tolerated also in patients with advanced renal insufficiency. Adverse events were reported in 6.7% of the patients. 89.3% of the physicians quoted to prefer transdermal buprenorphine with the two fixed patch change days per week compared to the pre-treatment. The buprenorphine-containing matrix patch was effective and well tolerated in patients with moderate to severe chronic cancer and noncancer pain. From the physicians view the two fixed patch change days per week facilitate the guidance of therapy. In patients with advanced renal insufficiency a dose adjustment is not necessary.

Capacity building efforts and perceptions for wildlife surveillance to detect zoonotic pathogens: comparing stakeholder perspectives.

PubMed

Schwind, Jessica S; Goldstein, Tracey; Thomas, Kate; Mazet, Jonna A K; Smith, Woutrina A

2014-07-04

The capacity to conduct zoonotic pathogen surveillance in wildlife is critical for the recognition and identification of emerging health threats. The PREDICT project, a component of United States Agency for International Development's Emerging Pandemic Threats program, has introduced capacity building efforts to increase zoonotic pathogen surveillance in wildlife in global 'hot spot' regions where zoonotic disease emergence is likely to occur. Understanding priorities, challenges, and opportunities from the perspectives of the stakeholders is a key component of any successful capacity building program. A survey was administered to wildlife officials and to PREDICT-implementing in-country project scientists in 16 participating countries in order to identify similarities and differences in perspectives between the groups regarding capacity needs for zoonotic pathogen surveillance in wildlife. Both stakeholder groups identified some human-animal interfaces (i.e. areas of high contact between wildlife and humans with the potential risk for disease transmission), such as hunting and markets, as important for ongoing targeting of wildlife surveillance. Similarly, findings regarding challenges across stakeholder groups showed some agreement in that a lack of sustainable funding across regions was the greatest challenge for conducting wildlife surveillance for zoonotic pathogens (wildlife officials: 96% and project scientists: 81%). However, the opportunity for improving zoonotic pathogen surveillance capacity identified most frequently by wildlife officials as important was increasing communication or coordination among agencies, sectors, or regions (100% of wildlife officials), whereas the most frequent opportunities identified as important by project scientists were increasing human capacity, increasing laboratory capacity, and the growing interest or awareness regarding wildlife disease or surveillance programs (all identified by 69% of project scientists). A One

Revised surveillance case definition for HIV infection--United States, 2014.

PubMed

2014-04-11

Following extensive consultation and peer review, CDC and the Council of State and Territorial Epidemiologists have revised and combined the surveillance case definitions for human immunodeficiency virus (HIV) infection into a single case definition for persons of all ages (i.e., adults and adolescents aged ≥13 years and children aged <13 years). The revisions were made to address multiple issues, the most important of which was the need to adapt to recent changes in diagnostic criteria. Laboratory criteria for defining a confirmed case now accommodate new multitest algorithms, including criteria for differentiating between HIV-1 and HIV-2 infection and for recognizing early HIV infection. A confirmed case can be classified in one of five HIV infection stages (0, 1, 2, 3, or unknown); early infection, recognized by a negative HIV test within 6 months of HIV diagnosis, is classified as stage 0, and acquired immunodeficiency syndrome (AIDS) is classified as stage 3. Criteria for stage 3 have been simplified by eliminating the need to differentiate between definitive and presumptive diagnoses of opportunistic illnesses. Clinical (nonlaboratory) criteria for defining a case for surveillance purposes have been made more practical by eliminating the requirement for information about laboratory tests. The surveillance case definition is intended primarily for monitoring the HIV infection burden and planning for prevention and care on a population level, not as a basis for clinical decisions for individual patients. CDC and the Council of State and Territorial Epidemiologists recommend that all states and territories conduct case surveillance of HIV infection using this revised surveillance case definition.

Mercury Surveillance Program

NASA Technical Reports Server (NTRS)

1993-01-01

Background on mercury exposure is presented including forms, sources, permissible exposure limits, and physiological effects. The purpose of the Mercury Surveillance Program at LeRC is outlined, and the specifics of the Medical Surveillance Program for Mercury Exposure at LeRC are discussed.

Implementation of Emergency Medical Text Classifier for Syndromic Surveillance

PubMed Central

Travers, Debbie; Haas, Stephanie W.; Waller, Anna E.; Schwartz, Todd A.; Mostafa, Javed; Best, Nakia C.; Crouch, John

2013-01-01

Public health officials use syndromic surveillance systems to facilitate early detection and response to infectious disease outbreaks. Emergency department clinical notes are becoming more available for surveillance but present the challenge of accurately extracting concepts from these text data. The purpose of this study was to implement a new system, Emergency Medical Text Classifier (EMT-C), into daily production for syndromic surveillance and evaluate system performance and user satisfaction. The system was designed to meet user preferences for a syndromic classifier that maximized positive predictive value and minimized false positives in order to provide a manageable workload. EMT-C performed better than the baseline system on all metrics and users were slightly more satisfied with it. It is vital to obtain user input and test new systems in the production environment. PMID:24551413

Implementation of Emergency Medical Text Classifier for syndromic surveillance.

PubMed

Travers, Debbie; Haas, Stephanie W; Waller, Anna E; Schwartz, Todd A; Mostafa, Javed; Best, Nakia C; Crouch, John

2013-01-01

Public health officials use syndromic surveillance systems to facilitate early detection and response to infectious disease outbreaks. Emergency department clinical notes are becoming more available for surveillance but present the challenge of accurately extracting concepts from these text data. The purpose of this study was to implement a new system, Emergency Medical Text Classifier (EMT-C), into daily production for syndromic surveillance and evaluate system performance and user satisfaction. The system was designed to meet user preferences for a syndromic classifier that maximized positive predictive value and minimized false positives in order to provide a manageable workload. EMT-C performed better than the baseline system on all metrics and users were slightly more satisfied with it. It is vital to obtain user input and test new systems in the production environment.

Circuits of Surveillance

PubMed Central

Williams, Robin; Johnson, Paul

2005-01-01

This paper examines the increasing police use of DNA profiling and databasing as a developing instrumentality of modern state surveillance. It briefly notes previously published work on a variety of surveillance technologies and their role in the governance of social action and social order. It then argues that there are important differences amongst the ways in which several such technologies construct and use identificatory artefacts, their orientations to human subjectivity, and their role in the governmentality of citizens and others. The paper then describes the novel and powerful form of bio-surveillance offered by DNA profiling and illustrates this by reference to an ongoing empirical study of the police uses of the UK National DNA Database for the investigation of crime. It is argued that DNA profiling and databasing enable the construction of a ‘closed circuit’ of surveillance of a defined population. PMID:16467920

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).

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.

Importance of Enhanced Surveillance for Prevention of Pertussis in Children.

PubMed

Domínguez, Angela; Godoy, Pere; Toledo, Diana; Soldevila, Núria; García-Cenoz, Manuel; Farrús, Gloria; Crespo, Inma; Caylà, Joan A; Sala, Maria Rosa; Camps, Neus; Barrabeig, Irene; Alvarez, Josep

2015-07-01

Bordetella pertussis infection causes considerable morbidity, even in countries with high vaccination coverage. Surveillance of pertussis is usually passive and based on mandatory reporting. We assessed the epidemiologic and clinical characteristics of pertussis cases detected by passive or enhanced surveillance. A prospective population-based study was carried out from January 2012 to December 2013 in Catalonia and Navarre, 2 Spanish regions with a total population of 8.2 million. For each confirmed case, variables of age, sex, clinical symptoms, laboratory results and vaccination status were investigated. Associations between the variables studied and the type of surveillance were assessed by odds ratio (OR) and its 95% confidence interval (CI). Logistic regression was used to estimate adjusted OR (aOR). In children <18 years of age, passive surveillance was the most important source of detection (95.7% in <1 year). In children 5-10 years of age, passive surveillance detected 67.5% of cases. In those ≥18 years, enhanced surveillance was the most frequent source of case detection (82.5%). Inspiratory whoop (aOR: 1.94; 95% CI: 1.40-2.70), apnea (aOR: 1.92; 95% CI: 1.28-2.87) and posttussive vomiting (aOR: 1.43; 95% CI: 1.04-1.96) were symptoms included in the clinical case definition that were associated with passive surveillance. Underreporting of symptomatic cases is important not only in adults, but also in children >1 year of age and suggests that providing clinics with free, fast laboratory diagnostic tests, together with enhanced surveillance of family contacts of any age is necessary to better determine existing cases. Enhanced surveillance may be helpful to better understand transmission patterns in the family and in the community.

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

Arsenic surveillance program

NASA Technical Reports Server (NTRS)

1993-01-01

Background information about arsenic is presented including forms, common sources, and clinical symptoms of arsenic exposure. The purpose of the Arsenic Surveillance Program and LeRC is outlined, and the specifics of the Medical Surveillance Program for Arsenic Exposure at LeRC are discussed.

New Method for Real Time Influenza Surveillance in Primary Care: A Wisconsin Research and Education Network (WREN) Supported Study.

PubMed

Temte, Jonathan L; Barlow, Shari; Schemmel, Amber; Temte, Emily; Hahn, David L; Reisdorf, Erik; Shult, Peter; Tamerius, John

2017-01-01

The goal of public health infectious disease surveillance systems is to provide accurate laboratory results in near-real time. When it comes to influenza surveillance, most current systems are encumbered with inherent delays encountered in the real-life chaos of medical practice. To combat this, we implemented and tested near-real-time surveillance using a rapid influenza detection test (RIDT) coupled with immediate, wireless transmission of results to public health entities. A network of 19 primary care clinics across Wisconsin were recruited, including 4 sites already involved in ongoing influenza surveillance and 15 sites that were new to surveillance activities. Each site was provided with a Quidel Sofia Influenza A+B RIDT analyzer attached to a wireless router. Influenza test results, along with patient age, were transmitted immediately to a cloud-based server, automatically compiled, and forwarded to the surveillance team daily. Weekly counts of positive influenza A and B cases were compared with positive polymerase chain reaction (PCR) detections from an independent surveillance system within the state. Following Institutional Review Board (IRB) and institutional approvals, we recruited 19 surveillance sites, installed equipment, and trained staff within 4 months. Of the 1119 cases tested between September 15, 2013 and June 28, 2014, 316 were positive for influenza. The system provided early detection of the influenza outbreak in Wisconsin. The influenza peak between January 12 and 25, 2014, as well as the epidemic curve, closely matched that derived from the established PCR laboratory network (r = 0.927; P < .001). A network of influenza RIDTs with wireless transmission of results approximated the long-sought-after goal of real-time influenza surveillance. Results from the initial year strongly support this approach to highly accurate and timely influenza surveillance. © Copyright 2017 by the American Board of Family Medicine.

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.

The current situation and development of medical device testing institutes in China.

PubMed

Yang, Xiaofang; Mu, Ruihong; Fan, Yubo; Wang, Chunren; Li, Deyu

2017-04-01

This article analyses the current situation and development of Chinese medical device testing institutes from the perspectives of the two most important functions - testing functions and medical device standardization functions. Areas Covered: The objective of the Chinese government regulations for medical device industry is to ensure the safety and effectiveness of medical devices for Chinese patients. To support the regulation system, the Chinese government has established medical device testing institutes at different levels for example, the national, provincial, and municipal levels. These testing institutes also play an important role in technical support during medical device premarket registration and post market surveillance, they are also the vital practitioners of Chinese medical device standardization. Expert Commentary: Chinese medical device testing institutes are technical departments established by government, and serve the regulatory functions of government agency. In recent years, with the rapid development of medical device industry as well as constantly increasing international and domestic medical device market, the importance of medical device testing institute is more prominent, However, there are still some problems unsolved, such as their overall capacity remains to be improved, construction of standardization is to be strengthened, etc.

Schistosomiasis in Scottish travellers: public health importance of laboratory testing and the need for enhanced surveillance.

PubMed

Alexander, Claire L; Cottom, Laura; Smith, Kitty; Perrow, Kali; Coyne, Michael; Jones, Brian L

2018-03-01

Imported schistosomiasis is of significant public health importance and is likely to be underestimated since infection is often asymptomatic. We describe data from travellers residing in Scotland which includes a subset of group travellers from one of the largest Health Boards in Scotland. Clotted bloods were obtained during the period 2001-15 from a total of 8163 Scottish travellers. This included seven groups comprising of 182 travellers. Sera were examined for the presence of Schistosome species antibody at the Scottish Parasite Diagnostic and Reference Laboratory (SPDRL). Of all, 25% (n = 1623) tested positive with 40% (n = 651) of those patients aged between 20 and 24 years. Although 62% (n = 1006) of those who tested positive reported travel to Africa, important information on the specific region visited was lacking in almost one-third of samples received. Overall, 62 (34%) of group travellers tested positive and 95% (n = 59) reporting travel to Africa. Globalization, affordable air travel and improved awareness, are likely to contribute towards the increasing number of imported schistosomiasis cases. Therefore, enhanced surveillance capturing detailed travel history and fresh water exposures will improve risk stratification, pre-travel advice and optimize testing and treatment regimes for this increasingly important parasitic disease.

Assessment of Arbovirus Surveillance 13 Years after Introduction of West Nile Virus, United States1

PubMed Central

Patel, Dhara; Nasci, Roger S.; Petersen, Lyle R.; Hughes, James M.; Bradley, Kristy; Etkind, Paul; Kan, Lilly; Engel, Jeffrey

2015-01-01

Before 1999, the United States had no appropriated funding for arboviral surveillance, and many states conducted no such surveillance. After emergence of West Nile virus (WNV), federal funding was distributed to state and selected local health departments to build WNV surveillance systems. The Council of State and Territorial Epidemiologists conducted assessments of surveillance capacity of resulting systems in 2004 and in 2012; the assessment in 2012 was conducted after a 61% decrease in federal funding. In 2004, nearly all states and assessed local health departments had well-developed animal, mosquito, and human surveillance systems to monitor WNV activity and anticipate outbreaks. In 2012, many health departments had decreased mosquito surveillance and laboratory testing capacity and had no systematic disease-based surveillance for other arboviruses. Arboviral surveillance in many states might no longer be sufficient to rapidly detect and provide information needed to fully respond to WNV outbreaks and other arboviral threats (e.g., dengue, chikungunya). PMID:26079471

48 CFR 242.1104 - Surveillance requirements.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 48 Federal Acquisition Regulations System 3 2011-10-01 2011-10-01 false Surveillance requirements... Surveillance and Reporting 242.1104 Surveillance requirements. (a) The cognizant contract administration office (CAO)— (i) Shall perform production surveillance on all contractors that have Criticality Designator A...

48 CFR 242.1104 - Surveillance requirements.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 48 Federal Acquisition Regulations System 3 2013-10-01 2013-10-01 false Surveillance requirements... Surveillance and Reporting 242.1104 Surveillance requirements. (a) The cognizant contract administration office (CAO)— (i) Shall perform production surveillance on all contractors that have Criticality Designator A...

48 CFR 242.1104 - Surveillance requirements.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 48 Federal Acquisition Regulations System 3 2014-10-01 2014-10-01 false Surveillance requirements... Surveillance and Reporting 242.1104 Surveillance requirements. (a) The cognizant contract administration office (CAO)— (i) Shall perform production surveillance on all contractors that have Criticality Designator A...

48 CFR 242.1104 - Surveillance requirements.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 48 Federal Acquisition Regulations System 3 2012-10-01 2012-10-01 false Surveillance requirements... Surveillance and Reporting 242.1104 Surveillance requirements. (a) The cognizant contract administration office (CAO)— (i) Shall perform production surveillance on all contractors that have Criticality Designator A...

Surveillance to Track Progress Toward Polio Eradication - Worldwide, 2016-2017.

PubMed

Gardner, Tracie J; Diop, Ousmane M; Jorba, Jaume; Chavan, Smita; Ahmed, Jamal; Anand, Abhijeet

2018-04-13

Global efforts to eradicate polio began in 1988, and four of the six World Health Organization (WHO) regions currently have achieved poliofree certification. Within the remaining two regions with endemic poliomyelitis (African and Eastern Mediterranean), Afghanistan, Nigeria, and Pakistan have never interrupted transmission of wild poliovirus (WPV). The primary means of detecting poliovirus transmission is surveillance for acute flaccid paralysis (AFP) among children aged <15 years, combined with collection and testing of stool specimens for detection of WPV and vaccine-derived polioviruses (VDPVs)* in WHO-accredited laboratories within the Global Polio Laboratory Network (GPLN) (1,2). AFP surveillance is supplemented by environmental surveillance for polioviruses in sewage from selected locations. Genomic sequencing of isolated polioviruses enables the mapping of transmission by time and place, assessment of potential gaps in surveillance, and identification of the emergence of VDPVs (3). This report presents poliovirus surveillance data from 2016-2017, with particular focus on six countries in the Eastern Mediterranean Region (EMR) and 20 countries in the African Region (AFR) that reported WPV or circulating VDPVs (cVDPVs) during 2011-2017. Included in the 20 AFR countries are the three most affected by the 2014-2015 Ebola virus disease (Ebola) outbreak (Guinea, Liberia, and Sierra Leone), even though only one (Guinea) reported WPV or cVDPVs during the surveillance period. During 2017, a total of 14 (70%) of the 20 AFR countries and five (83%) of the six EMR countries met both surveillance quality indicators at the national level; however, provincial-level variation was seen. Surveillance strengthening activities are needed in specific countries of these regions to provide evidence supporting ultimate certification of the interruption of poliovirus circulation.

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

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.

LWR pressure vessel surveillance dosimetry improvement program: LWR power reactor surveillance physics-dosimetry data base compendium

DOE Office of Scientific and Technical Information (OSTI.GOV)

McElroy, W.N.

1985-08-01

This NRC physics-dosimetry compendium is a collation of information and data developed from available research and commercial light water reactor vessel surveillance program (RVSP) documents and related surveillance capsule reports. The data represents the results of the HEDL least-squares FERRET-SAND II Code re-evaluation of exposure units and values for 47 PWR and BWR surveillance capsules for W, B and W, CE, and GE power plants. Using a consistent set of auxiliary data and dosimetry-adjusted reactor physics results, the revised fluence values for E > 1 MeV averaged 25% higher than the originally reported values. The range of fluence values (new/old)more » was from a low of 0.80 to a high of 2.38. These HEDL-derived FERRET-SAND II exposure parameter values are being used for NRC-supported HEDL and other PWR and BWR trend curve data development and testing studies. These studies are providing results to support Revision 2 of Regulatory Guide 1.99. As stated by Randall (Ra84), the Guide is being updated to reflect recent studies of the physical basis for neutron radiation damage and efforts to correlate damage to chemical composition and fluence.« less

Surveillance for outbreaks of influenza-like illness in the institutionalized elderly.

PubMed

Rosewell, A; Chiu, C; Lindley, R; Dwyer, D E; Moffatt, C R M; Shineberg, C; Clarke, E; Booy, R; MacIntyre, C R

2010-08-01

Respiratory outbreaks are common in aged-care facilities (ACFs), are both underreported and frequently identified late, and are often associated with considerable burden of illness and death. There is emerging evidence that active surveillance coupled with early and systematic intervention can reduce this burden. Active surveillance for influenza-like illness and rapid diagnosis of influenza were established in 16 ACFs in Sydney, Australia, prior to the winter of 2006. A point-of-care influenza test and laboratory direct immunofluorescence tests for common respiratory viruses were used for diagnosis. We achieved early identification of seven respiratory disease outbreaks, two of which were caused by influenza. For the influenza outbreaks, antiviral treatment and prophylaxis were initiated 4-6 days from symptom onset in the primary case. A simple active surveillance system for influenza was successfully implemented and resulted in early detection of influenza and other respiratory disease outbreaks. This enabled earlier implementation of prevention and control measures and increased the potential effectiveness of anti-influenza chemoprophylaxis.

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.

48 CFR 44.304 - Surveillance.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 48 Federal Acquisition Regulations System 1 2011-10-01 2011-10-01 false Surveillance. 44.304... SUBCONTRACTING POLICIES AND PROCEDURES Contractors' Purchasing Systems Reviews 44.304 Surveillance. (a) The ACO shall maintain a sufficient level of surveillance to ensure that the contractor is effectively managing...

48 CFR 44.304 - Surveillance.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 48 Federal Acquisition Regulations System 1 2014-10-01 2014-10-01 false Surveillance. 44.304... SUBCONTRACTING POLICIES AND PROCEDURES Contractors' Purchasing Systems Reviews 44.304 Surveillance. (a) The ACO shall maintain a sufficient level of surveillance to ensure that the contractor is effectively managing...

48 CFR 44.304 - Surveillance.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 1 2010-10-01 2010-10-01 false Surveillance. 44.304... SUBCONTRACTING POLICIES AND PROCEDURES Contractors' Purchasing Systems Reviews 44.304 Surveillance. (a) The ACO shall maintain a sufficient level of surveillance to ensure that the contractor is effectively managing...

48 CFR 44.304 - Surveillance.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 48 Federal Acquisition Regulations System 1 2013-10-01 2013-10-01 false Surveillance. 44.304... SUBCONTRACTING POLICIES AND PROCEDURES Contractors' Purchasing Systems Reviews 44.304 Surveillance. (a) The ACO shall maintain a sufficient level of surveillance to ensure that the contractor is effectively managing...

48 CFR 44.304 - Surveillance.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 48 Federal Acquisition Regulations System 1 2012-10-01 2012-10-01 false Surveillance. 44.304... SUBCONTRACTING POLICIES AND PROCEDURES Contractors' Purchasing Systems Reviews 44.304 Surveillance. (a) The ACO shall maintain a sufficient level of surveillance to ensure that the contractor is effectively managing...

[Cost estimation of an epidemiological surveillance network for animal diseases in Central Africa: a case study of the Chad network].

PubMed

Ouagal, M; Berkvens, D; Hendrikx, P; Fecher-Bourgeois, F; Saegerman, C

2012-12-01

In sub-Saharan Africa, most epidemiological surveillance networks for animal diseases were temporarily funded by foreign aid. It should be possible for national public funds to ensure the sustainability of such decision support tools. Taking the epidemiological surveillance network for animal diseases in Chad (REPIMAT) as an example, this study aims to estimate the network's cost by identifying the various costs and expenditures for each level of intervention. The network cost was estimated on the basis of an analysis of the operational organisation of REPIMAT, additional data collected in surveys and interviews with network field workers and a market price listing for Chad. These costs were then compared with those of other epidemiological surveillance networks in West Africa. The study results indicate that REPIMAT costs account for 3% of the State budget allocated to the Ministry of Livestock. In Chad in general, as in other West African countries, fixed costs outweigh variable costs at every level of intervention. The cost of surveillance principally depends on what is needed for surveillance at the local level (monitoring stations) and at the intermediate level (official livestock sectors and regional livestock delegations) and on the cost of the necessary equipment. In African countries, the cost of surveillance per square kilometre depends on livestock density.

Surveillance on A/H5N1 virus in domestic poultry and wild birds in Egypt

PubMed Central

2013-01-01

Background The endemic H5N1 high pathogenicity avian influenza virus (A/H5N1) in poultry in Egypt continues to cause heavy losses in poultry and poses a significant threat to human health. Methods Here we describe results of A/H5N1 surveillance in domestic poultry in 2009 and wild birds in 2009–2010. Tracheal and cloacal swabs were collected from domestic poultry from 22024 commercial farms, 1435 backyards and 944 live bird markets (LBMs) as well as from 1297 wild birds representing 28 different types of migratory birds. Viral RNA was extracted from a mix of tracheal and cloacal swabs media. Matrix gene of avian influenza type A virus was detected using specific real-time reverse-transcription polymerase chain reaction (RT-qPCR) and positive samples were tested by RT-qPCR for simultaneous detection of the H5 and N1 genes. Results In this surveillance, A/H5N1 was detected from 0.1% (n = 23/) of examined commercial poultry farms, 10.5% (n = 151) of backyard birds and 11.4% (n = 108) of LBMs but no wild bird tested positive for A/H5N1. The virus was detected from domestic poultry year-round with higher incidence in the warmer months of summer and spring particularly in backyard birds. Outbreaks were recorded mostly in Lower Egypt where 95.7% (n = 22), 68.9% (n = 104) and 52.8% (n = 57) of positive commercial farms, backyards and LBMs were detected, respectively. Higher prevalence (56%, n = 85) was reported in backyards that had mixed chickens and waterfowl together in the same vicinity and LBMs that had waterfowl (76%, n = 82). Conclusion Our findings indicated broad circulation of the endemic A/H5N1 among poultry in 2009 in Egypt. In addition, the epidemiology of A/H5N1 has changed over time with outbreaks occurring in the warmer months of the year. Backyard waterfowl may play a role as a reservoir and/or source of A/H5N1 particularly in LBMs. The virus has been established in poultry in the Nile Delta where major metropolitan areas

Integrated Diseases Surveillance Project (IDSP) through a consultant's lens.

PubMed

Suresh, K

2008-01-01

India has long experienced one of the highest burdens of infectious diseases in the world, fueled by factors including a large population, high poverty levels, poor sanitation, and problems with access to health care and preventive services. It has traditionally been difficult to monitor disease burden and trends in India, even more difficult to detect, diagnose, and control outbreaks until they had become quite large. In an effort to improve the surveillance and response infrastructure in the country, in November 2004 the Integrated Disease Surveillance Project (IDSP) was initiated with funding from the World Bank. Given the surveillance challenges in India, the project seeks to accomplish its goals through, having a small list of priority conditions, many of which are syndrome-based at community and sub center level and easily recognizable at the out patients and inpatients care of facilities at lowest levels of the health care system, a simplified battery of laboratory tests and rapid test kits, and reporting of largely aggregate data rather than individual case reporting. The project also includes activities that are relatively high technology, such as computerization, electronic data transmission, and video conferencing links for communication and training. The project is planned to be implemented all over the country in a phased manner with a stress on 14 focus states for intensive follow-up to demonstrate successful implementation of IDSP. The National Institute of Communicable Diseases chosen to provide national leadership may have to immediately address five issues. First, promote surveillance through major hospitals (both in public and private sector) and active surveillance through health system staff and community, second, build capacity for data collation, analysis, interpretation to recognize warning signal of outbreak, and institute public health action, third, develop a system which allows availability of quality test kits at district and state

[Active surveillance of adverse drug reaction in the era of big data: challenge and opportunity for control selection].

PubMed

Wang, S F; Zhan, S Y

2016-07-01

Electronic healthcare databases have become an important source for active surveillance of drug safety in the era of big data. The traditional epidemiology research designs are needed to confirm the association between drug use and adverse events based on these datasets, and the selection of the comparative control is essential to each design. This article aims to explain the principle and application of each type of control selection, introduce the methods and parameters for method comparison, and describe the latest achievements in the batch processing of control selection, which would provide important methodological reference for the use of electronic healthcare databases to conduct post-marketing drug safety surveillance in China.

NASA Low Visibility Landing and Surface Operations (LVLASO) Atlanta Demonstration: Surveillance Systems Performance Analysis

NASA Technical Reports Server (NTRS)

Cassell, Rick; Evers, Carl; Hicok, Dan; Lee, Derrick

1999-01-01

NASA conducted a series of flight experiments at Hartsfield Atlanta International Airport as part of the Low Visibility Landing and Surface Operations (LVLASO) Program. LVLASO is one of the subelements of the NASA Terminal Area Productivity (TAP) Program, which is focused on providing technology and operating procedures for achieving clear-weather airport capacity in instrument-weather conditions, while also improving safety. LVLASO is investigating various technologies to be applied to airport surface operations, including advanced flight deck displays and surveillance systems. The purpose of this report is to document the performance of the surveillance systems tested as part of the LVLASO flight experiment. There were three surveillance sensors tested: primary radar using Airport Surface Detection Equipment (ASDE-3) and the Airport Movement Area Safety System (AMASS), Multilateration using the Airport Surface Target Identification System (ATIDS), and Automatic Dependent Surveillance - Broadcast (ADS-B) operating at 1090 MHz. The performance was compared to the draft requirements of the ICAO Advanced Surface Movement Guidance and Control System (A-SMGCS). Performance parameters evaluated included coverage, position accuracy, and update rate. Each of the sensors was evaluated as a stand alone surveillance system.

Drinking Water Quality Surveillance in a Vulnerable Urban Ward of Ahmedabad.

PubMed

Iyer, Veena; Choudhury, Nandini; Azhar, Gulrez Shah; Somvanshi, Bhushan

2014-05-01

The World Bank estimates that 21% of all communicable diseases in India are related to unsafe water with diarrhoea alone causing more than 0.1 million deaths annually. The WHO drinking water surveillance parameters of quality, quantity, accessibility, affordability and continuity were assessed in one vulnerable ward of Ahmedabad-a fast growing city in Western India. Interviews with key informants of the ward office, health centre and water supply department, secondary analysis and mapping of field test reports and a questionnaire-based survey of different household types were conducted. We found that Ahmedabad Municipal Corporation (AMC) supplies water to the ward intermittently for two hours during the day. Housing society clusters supplement their AMC water supply with untested bore-well water. The water quality surveillance system is designed for a twenty-four-hour piped distribution of treated surface water. However, in order to maintain surveillance over an intermittent supply that includes ground water, the sampling process should include periodic surveys of water actually consumed by the citizens. The laboratory capacity of the Central Water Testing Laboratory should expand to include more refined tests for microbial and chemical contamination.

Evaluation of the influenza sentinel surveillance system in Madagascar, 2009–2014

PubMed Central

Rakotoarisoa, Alain; Randrianasolo, Laurence; Tempia, Stefano; Guillebaud, Julia; Razanajatovo, Norosoa; Randriamampionona, Lea; Piola, Patrice; Halm, Ariane

2017-01-01

Abstract Problem Evaluation of influenza surveillance systems is poor, especially in Africa. Approach In 2007, the Institut Pasteur de Madagascar and the Malagasy Ministry of Public Health implemented a countrywide system for the prospective syndromic and virological surveillance of influenza-like illnesses. In assessing this system’s performance, we identified gaps and ways to promote the best use of resources. We investigated acceptability, data quality, flexibility, representativeness, simplicity, stability, timeliness and usefulness and developed qualitative and/or quantitative indicators for each of these attributes. Local setting Until 2007, the influenza surveillance system in Madagascar was only operational in Antananarivo and the observations made could not be extrapolated to the entire country. Relevant changes By 2014, the system covered 34 sentinel sites across the country. At 12 sites, nasopharyngeal and/or oropharyngeal samples were collected and tested for influenza virus. Between 2009 and 2014, 177 718 fever cases were detected, 25 809 (14.5%) of these fever cases were classified as cases of influenza-like illness. Of the 9192 samples from patients with influenza-like illness that were tested for influenza viruses, 3573 (38.9%) tested positive. Data quality for all evaluated indicators was categorized as above 90% and the system also appeared to be strong in terms of its acceptability, simplicity and stability. However, sample collection needed improvement. Lessons learnt The influenza surveillance system in Madagascar performed well and provided reliable and timely data for public health interventions. Given its flexibility and overall moderate cost, this system may become a useful platform for syndromic and laboratory-based surveillance in other low-resource settings. PMID:28479639

Lead Surveillance Program

NASA Technical Reports Server (NTRS)

1993-01-01

Background on lead exposure is presented including forms of lead, sources, hematologic effects, neurologic effects, endocrine effects, renal effects, and reproductive and developmental effects. The purpose of the Lead Surveillance Program at LeRC is outlined, and the specifics of the Medical Surveillance Program for Lead Exposure at LeRC are discussed.

Evaluation of a Multivariate Syndromic Surveillance System for West Nile Virus.

PubMed

Faverjon, Céline; Andersson, M Gunnar; Decors, Anouk; Tapprest, Jackie; Tritz, Pierre; Sandoz, Alain; Kutasi, Orsolya; Sala, Carole; Leblond, Agnès

2016-06-01

Various methods are currently used for the early detection of West Nile virus (WNV) but their outputs are not quantitative and/or do not take into account all available information. Our study aimed to test a multivariate syndromic surveillance system to evaluate if the sensitivity and the specificity of detection of WNV could be improved. Weekly time series data on nervous syndromes in horses and mortality in both horses and wild birds were used. Baselines were fitted to the three time series and used to simulate 100 years of surveillance data. WNV outbreaks were simulated and inserted into the baselines based on historical data and expert opinion. Univariate and multivariate syndromic surveillance systems were tested to gauge how well they detected the outbreaks; detection was based on an empirical Bayesian approach. The systems' performances were compared using measures of sensitivity, specificity, and area under receiver operating characteristic curve (AUC). When data sources were considered separately (i.e., univariate systems), the best detection performance was obtained using the data set of nervous symptoms in horses compared to those of bird and horse mortality (AUCs equal to 0.80, 0.75, and 0.50, respectively). A multivariate outbreak detection system that used nervous symptoms in horses and bird mortality generated the best performance (AUC = 0.87). The proposed approach is suitable for performing multivariate syndromic surveillance of WNV outbreaks. This is particularly relevant, given that a multivariate surveillance system performed better than a univariate approach. Such a surveillance system could be especially useful in serving as an alert for the possibility of human viral infections. This approach can be also used for other diseases for which multiple sources of evidence are available.

Child development in primary care: a surveillance proposal.

PubMed

Coelho, Renato; Ferreira, José Paulo; Sukiennik, Ricardo; Halpern, Ricardo

2016-01-01

To evaluate a child development surveillance tool proposal to be used in primary care, with simultaneous use of the Denver II scale. This was a cross-sectional study of 282 infants aged up to 36 months, enrolled in a public daycare in a countryside community in Rio Grande do Sul/Brazil. Child development was assessed using the surveillance tool and the Denver II scale. The prevalence of probable developmental delay was 53%; most of these cases were in the alert group and 24% had normal development, but with risk factors. At the Denver scale, the prevalence of suspected developmental delay was 32%. When risk factors and sociodemographic variables were assessed, no significant difference was observed. The evaluation of this surveillance tool resulted in objective and comparable data, which were adequate for a screening test. It is easily applicable as a screening tool, even though it was originally designed as a surveillance tool. The inclusion of risk factors to the scoring system is an innovation that allows for the identification of children with suspected delay in addition to developmental milestones, although the definition of parameters and choice of indicators should be thoroughly studied. Copyright © 2016 Sociedade Brasileira de Pediatria. Published by Elsevier Editora Ltda. All rights reserved.

The Lifetime Surveillance of Astronaut Health (LSAH) Project

NASA Technical Reports Server (NTRS)

Bopp, Eugenia; Wear, Mary L.; Lee, Lesley R.; VanBaalen, Mary

2013-01-01

From 1989-2010 NASA conducted a research study, the Longitudinal Study of Astronaut Health, to investigate the incidence of acute and chronic morbidity and mortality in astronauts and to determine whether their occupational exposures were associated with increased risk of death or disability. In 2004, the Institute of Medicine recommended that NASA convert the longitudinal study into an occupational health surveillance program and in 2010, NASA initiated the Lifetime Surveillance of Astronaut Health project. The new program collects data on astronaut workplace exposures, especially those occurring in the training and space flight environments, and conducts operational and health care analyses to look for trends in exposure and health outcomes. Astronaut selection and retention medical standards are rigorous, requiring an extensive clinical testing regimen. As a result, this employee population has contributed to a large set of health data available for analyses. Astronauts represent a special population with occupational exposures not typically experienced by other employee populations. Additionally, astronauts are different from the general population in terms of demographic and physiologic characteristics. The challenges and benefits of conducting health surveillance for an employee population with unique occupational exposures will be discussed. Several occupational surveillance projects currently underway to examine associations between astronaut workplace exposures and medical outcomes will be described.

Selection of 3013 Containers for Field Surveillance. Fiscal Year 2016 Update

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kelly, Elizabeth J.; Berg, John M.; Cheadle, Jesse

2016-04-19

This update is the eighth in a series of reports that document the binning and sample selection of 3013 containers for the Field Surveillance program as part of the Integrated Surveillance Program. This report documents changes made to both the container binning assignments and the sample selection approach. Binning changes documented in this update are a result of changes to the prompt gamma calibration curves and the reassignment of a small number of Hanford items from the Pressure bin to the Pressure and Corrosion (P&C) bin. Field Surveillance sample selection changes are primarily a result of focusing future destructive examinationsmore » (DEs) on the potential for stress corrosion cracking in higher moisture containers in the P&C bin. The decision to focus the Field Surveillance program on higher moisture items is based on findings from both the Shelf-life testing program and DEs.« less

A Post-Marketing Surveillance Study to Evaluate Performance of the EXIMO™ Blood Glucose Monitoring System.

PubMed

Chandnani, Sonia R; Ramakrishna, C D; Dave, Bhargav A; Kothavade, Pankaj S; Thakkar, Ashok S

2017-05-01

The performance of Blood Glucose Monitoring System (BGMS) is critical as the information provided by the system guide the patient or health care professional in making treatment decisions. However, besides evaluating accuracy of the BGMS in laboratory setting, it is equally important that the intended users (healthcare professionals and patients) should be able to achieve blood glucose measurements with similar level of high accuracy. To assess the performance of EXIMO™ (Meril Diagnostics Pvt. Ltd., Vapi, Gujarat, India) BGMS as per International Organization for Standardization (ISO) 15197:2013 section 8 user performance criteria. This was a non-randomized and post-marketing study conducted at a tertiary care centre of India. A total of 1005 patients with diabetes themselves performed fingertip blood glucose measurement using EXIMO™ BGMS. Immediately after capillary blood glucose measurement using the blood glucose monitoring system, venous blood sample from each patient was obtained by a trained technician which was assessed by reference laboratory method- Cobas Integra 400 plus (Roche Instrument Centre, Rotkreuz, Switzerland). All the blood glucose measurements assessed by EXIMO™ were compared with laboratory results. Performance of the system was assessed as per ISO 15197:2013 criteria using Bland-Altman plot, Parkes-Consensus Error Grid (CEG) and Surveillance Error Grid analyses (SEG). A total of 1005 patients participated in the study. Average age of the patients was 44.93±14.65 years. Evaluation of capillary fingertip blood glucose measurements demonstrated that 95.82% measurements fulfilled ISO 15197:2013 section 8 user performance criteria. All the results lie within clinically non-critical zones; Zone A (99.47%; n=1000) and Zone B (0.53%; n=05) of the CEG analysis. As per SEG analysis, majority of the results fell within "no-risk" zone (risk score 0 to 0.5; 90.42%). The result of the study confirmed that intended users are able to obtain accurate

A Post-Marketing Surveillance Study to Evaluate Performance of the EXIMO™ Blood Glucose Monitoring System

PubMed Central

Chandnani, Sonia R.; Ramakrishna, C. D.; Dave, Bhargav A.; Kothavade, Pankaj S.

2017-01-01

Introduction The performance of Blood Glucose Monitoring System (BGMS) is critical as the information provided by the system guide the patient or health care professional in making treatment decisions. However, besides evaluating accuracy of the BGMS in laboratory setting, it is equally important that the intended users (healthcare professionals and patients) should be able to achieve blood glucose measurements with similar level of high accuracy. Aim To assess the performance of EXIMO™ (Meril Diagnostics Pvt. Ltd., Vapi, Gujarat, India) BGMS as per International Organization for Standardization (ISO) 15197:2013 section 8 user performance criteria. Materials and Methods This was a non-randomized and post-marketing study conducted at a tertiary care centre of India. A total of 1005 patients with diabetes themselves performed fingertip blood glucose measurement using EXIMO™ BGMS. Immediately after capillary blood glucose measurement using the blood glucose monitoring system, venous blood sample from each patient was obtained by a trained technician which was assessed by reference laboratory method- Cobas Integra 400 plus (Roche Instrument Centre, Rotkreuz, Switzerland). All the blood glucose measurements assessed by EXIMO™ were compared with laboratory results. Performance of the system was assessed as per ISO 15197:2013 criteria using Bland-Altman plot, Parkes-Consensus Error Grid (CEG) and Surveillance Error Grid analyses (SEG). Results A total of 1005 patients participated in the study. Average age of the patients was 44.93±14.65 years. Evaluation of capillary fingertip blood glucose measurements demonstrated that 95.82% measurements fulfilled ISO 15197:2013 section 8 user performance criteria. All the results lie within clinically non-critical zones; Zone A (99.47%; n=1000) and Zone B (0.53%; n=05) of the CEG analysis. As per SEG analysis, majority of the results fell within “no-risk” zone (risk score 0 to 0.5; 90.42%). Conclusion The result of the

Cost Analysis of Various Low Pathogenic Avian Influenza Surveillance Systems in the Dutch Egg Layer Sector

PubMed Central

Rutten, Niels; Gonzales, José L.; Elbers, Armin R. W.; Velthuis, Annet G. J.

2012-01-01

Background As low pathogenic avian influenza viruses can mutate into high pathogenic viruses the Dutch poultry sector implemented a surveillance system for low pathogenic avian influenza (LPAI) based on blood samples. It has been suggested that egg yolk samples could be sampled instead of blood samples to survey egg layer farms. To support future decision making about AI surveillance economic criteria are important. Therefore a cost analysis is performed on systems that use either blood or eggs as sampled material. Methodology/Principal Findings The effectiveness of surveillance using egg or blood samples was evaluated using scenario tree models. Then an economic model was developed that calculates the total costs for eight surveillance systems that have equal effectiveness. The model considers costs for sampling, sample preparation, sample transport, testing, communication of test results and for the confirmation test on false positive results. The surveillance systems varied in sampled material (eggs or blood), sampling location (farm or packing station) and location of sample preparation (laboratory or packing station). It is shown that a hypothetical system in which eggs are sampled at the packing station and samples prepared in a laboratory had the lowest total costs (i.e. € 273,393) a year. Compared to this a hypothetical system in which eggs are sampled at the farm and samples prepared at a laboratory, and the currently implemented system in which blood is sampled at the farm and samples prepared at a laboratory have 6% and 39% higher costs respectively. Conclusions/Significance This study shows that surveillance for avian influenza on egg yolk samples can be done at lower costs than surveillance based on blood samples. The model can be used in future comparison of surveillance systems for different pathogens and hazards. PMID:22523543

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. Copyright © 2011 Elsevier B.V. All

How to Conduct Store Observations of Tobacco Marketing and Products.

PubMed

Feld, Ashley L; Johnson, Trent O; Byerly, Katherine W; Ribisl, Kurt M

2016-02-18

As tobacco companies continue to heavily market their products at the point of sale, tobacco control groups seek strategies to combat the negative effects of this marketing. Store observations, which have been widely used by researchers and practitioners alike, are an excellent surveillance tool. This article provides a guide for public health practitioners interested in working in the tobacco retail environment by detailing the steps involved in conducting store observations of tobacco marketing and products including 1) obtaining tobacco product retailer lists, 2) creating measures, 3) selecting a mode of data collection, 4) training data collectors, and 5) analyzing data. We also highlight issues that may arise while in the field and provide information on disseminating results of store observations, including the potential policy implications.

How to Conduct Store Observations of Tobacco Marketing and Products

PubMed Central

Feld, Ashley L.; Johnson, Trent O.; Byerly, Katherine W.

2016-01-01

As tobacco companies continue to heavily market their products at the point of sale, tobacco control groups seek strategies to combat the negative effects of this marketing. Store observations, which have been widely used by researchers and practitioners alike, are an excellent surveillance tool. This article provides a guide for public health practitioners interested in working in the tobacco retail environment by detailing the steps involved in conducting store observations of tobacco marketing and products including 1) obtaining tobacco product retailer lists, 2) creating measures, 3) selecting a mode of data collection, 4) training data collectors, and 5) analyzing data. We also highlight issues that may arise while in the field and provide information on disseminating results of store observations, including the potential policy implications. PMID:26890408

Congenital rubella syndrome surveillance in Honduras.

PubMed

Molina, Ida Berenice; Mendoza, Lourdes Otilia; Palma, María Aparicia

2011-09-01

Congenital rubella syndrome (CRS) surveillance was established in Honduras to determine the scope of the problem and assess the impact of vaccination. Implementation of the surveillance system required the drafting of national CRS epidemiological surveillance guidelines, the development of a laboratory diagnostic method, and training of physicians, nurses, and microbiologists in the Honduran hospital network and social security system on CRS surveillance guidelines. Honduras' experience with the surveillance of other vaccine-preventable diseases facilitated the implementation of hospital-based CRS surveillance. The surveillance system operates in 23 of the 25 public hospitals that offer services to children and at 2 social security hospitals; the private sector has not been integrated into this system. Clinical and technical staff, including representatives from various disciplines such as pediatrics, neonatology, general medicine, epidemiology, nursing, and microbiology, participate in the hospital network, as well as follow up on cases in accordance with the standardized guidelines, depending on their areas of expertise. Implementation of the CRS surveillance system requires technical guidelines, laboratory diagnostic capacity, and trained multidisciplinary human resources for its systematization and operation.

A Global Cancer Surveillance Framework Within Noncommunicable Disease Surveillance: Making the Case for Population-Based Cancer Registries.

PubMed

Piñeros, Marion; Znaor, Ariana; Mery, Les; Bray, Freddie

2017-01-01

The growing burden of cancer among several major noncommunicable diseases (NCDs) requires national implementation of tailored public health surveillance. For many emerging economies where emphasis has traditionally been placed on the surveillance of communicable diseases, it is critical to understand the specificities of NCD surveillance and, within it, of cancer surveillance. We propose a general framework for cancer surveillance that permits monitoring the core components of cancer control. We examine communalities in approaches to the surveillance of other major NCDs as well as communicable diseases, illustrating key differences in the function, coverage, and reporting in each system. Although risk factor surveys and vital statistics registration are the foundation of surveillance of NCDs, population-based cancer registries play a unique fundamental role specific to cancer surveillance, providing indicators of population-based incidence and survival. With an onus now placed on governments to collect these data as part of the monitoring of NCD targets, the integration of cancer registries into existing and future NCD surveillance strategies is a vital requirement in all countries worldwide. The Global Initiative for Cancer Registry Development, endorsed by the World Health Organization, provides a means to enhance cancer surveillance capacity in low- and middle-income countries. © The Author 2017. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Development of Disease-specific, Context-specific Surveillance Models: Avian Influenza (H5N1)-Related Risks and Behaviours in African Countries.

PubMed

Fasina, F O; Njage, P M K; Ali, A M M; Yilma, J M; Bwala, D G; Rivas, A L; Stegeman, A J

2016-02-01

Avian influenza virus (H5N1) is a rapidly disseminating infection that affects poultry and, potentially, humans. Because the avian virus has already adapted to several mammalian species, decreasing the rate of avian-mammalian contacts is critical to diminish the chances of a total adaptation of H5N1 to humans. To prevent the pandemic such adaptation could facilitate, a biology-specific disease surveillance model is needed, which should also consider geographical and socio-cultural factors. Here, we conceptualized a surveillance model meant to capture H5N1-related biological and cultural aspects, which included food processing, trade and cooking-related practices, as well as incentives (or disincentives) for desirable behaviours. This proof of concept was tested with data collected from 378 Egyptian and Nigerian sites (local [backyard] producers/live bird markets/village abattoirs/commercial abattoirs and veterinary agencies). Findings revealed numerous opportunities for pathogens to disseminate, as well as lack of incentives to adopt preventive measures, and factors that promoted epidemic dissemination. Supporting such observations, the estimated risk for H5N1-related human mortality was higher than previously reported. The need for multidimensional disease surveillance models, which may detect risks at higher levels than models that only measure one factor or outcome, was supported. To develop efficient surveillance systems, interactions should be captured, which include but exceed biological factors. This low-cost and easily implementable model, if conducted over time, may identify focal instances where tailored policies may diminish both endemicity and the total adaptation of H5N1 to the human species. © 2015 Blackwell Verlag GmbH.

The assessment of data sources for influenza virologic surveillance in New York State.

PubMed

Escuyer, Kay L; Waters, Christine L; Gowie, Donna L; Maxted, Angie M; Farrell, Gregory M; Fuschino, Meghan E; St George, Kirsten

2017-03-01

Following the 2013 USA release of the Influenza Virologic Surveillance Right Size Roadmap, the New York State Department of Health (NYSDOH) embarked on an evaluation of data sources for influenza virologic surveillance. To assess NYS data sources, additional to data generated by the state public health laboratory (PHL), which could enhance influenza surveillance at the state and national level. Potential sources of laboratory test data for influenza were analyzed for quantity and quality. Computer models, designed to assess sample sizes and the confidence of data for statistical representation of influenza activity, were used to compare PHL test data to results from clinical and commercial laboratories, reported between June 8, 2013 and May 31, 2014. Sample sizes tested for influenza at the state PHL were sufficient for situational awareness surveillance with optimal confidence levels, only during peak weeks of the influenza season. Influenza data pooled from NYS PHLs and clinical laboratories generated optimal confidence levels for situational awareness throughout the influenza season. For novel influenza virus detection in NYS, combined real-time (rt) RT-PCR data from state and regional PHLs achieved ≥85% confidence during peak influenza activity, and ≥95% confidence for most of low season and all of off-season. In NYS, combined data from clinical, commercial, and public health laboratories generated optimal influenza surveillance for situational awareness throughout the season. Statistical confidence for novel virus detection, which is reliant on only PHL data, was achieved for most of the year. © 2016 The Authors. Influenza and Other Respiratory Viruses Published by John Wiley & Sons Ltd.

Cholera Incidence and Mortality in Sub-Saharan African Sites during Multi-country Surveillance

PubMed Central

Sauvageot, Delphine; Njanpop-Lafourcade, Berthe-Marie; Akilimali, Laurent; Anne, Jean-Claude; Bidjada, Pawou; Bompangue, Didier; Bwire, Godfrey; Coulibaly, Daouda; Dengo-Baloi, Liliana; Dosso, Mireille; Orach, Christopher Garimoi; Inguane, Dorteia; Kagirita, Atek; Kacou-N’Douba, Adele; Keita, Sakoba; Kere Banla, Abiba; Kouame, Yao Jean-Pierre; Landoh, Dadja Essoya; Langa, Jose Paulo; Makumbi, Issa; Miwanda, Berthe; Malimbo, Muggaga; Mutombo, Guy; Mutombo, Annie; NGuetta, Emilienne Niamke; Saliou, Mamadou; Sarr, Veronique; Senga, Raphael Kakongo; Sory, Fode; Sema, Cynthia; Tante, Ouyi Valentin; Gessner, Bradford D.; Mengel, Martin A.

2016-01-01

Background Cholera burden in Africa remains unknown, often because of weak national surveillance systems. We analyzed data from the African Cholera Surveillance Network (www.africhol.org). Methods/ Principal findings During June 2011–December 2013, we conducted enhanced surveillance in seven zones and four outbreak sites in Togo, the Democratic Republic of Congo (DRC), Guinea, Uganda, Mozambique and Cote d’Ivoire. All health facilities treating cholera cases were included. Cholera incidences were calculated using culture-confirmed cholera cases and culture-confirmed cholera cases corrected for lack of culture testing usually due to overwhelmed health systems and imperfect test sensitivity. Of 13,377 reported suspected cases, 34% occurred in Conakry, Guinea, 47% in Goma, DRC, and 19% in the remaining sites. From 0–40% of suspected cases were aged under five years and from 0.3–86% had rice water stools. Within surveillance zones, 0–37% of suspected cases had confirmed cholera compared to 27–38% during outbreaks. Annual confirmed incidence per 10,000 population was <0.5 in surveillance zones, except Goma where it was 4.6. Goma and Conakry had corrected incidences of 20.2 and 5.8 respectively, while the other zones a median of 0.3. During outbreaks, corrected incidence varied from 2.6 to 13.0. Case fatality ratios ranged from 0–10% (median, 1%) by country. Conclusions/Significance Across different African epidemiological contexts, substantial variation occurred in cholera incidence, age distribution, clinical presentation, culture confirmation, and testing frequency. These results can help guide preventive activities, including vaccine use. PMID:27186885

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.

How can cardiothoracic and vascular medical devices stay in the market?

PubMed

Wong, Kathie A; Hodgson, Luke; Garas, George; Malietzis, George; Markar, Sheraz; Rao, Christopher; von Segesser, Ludwig K; Athanasiou, Thanos

2016-12-01

Surgeons, as the consumers, must engage in commercial activity regarding medical devices since it directly has impacts on surgical practice and patient outcomes. Unique features defy traditional economic convention in this specific market partly because consumers do not usually pay directly. Greater involvement with commercial activity means better post-market surveillance of medical devices which leads to improved patient safety. The medical device industry has exhibited astonishing levels of growth and profitability reaching $398 billion on a global scale with new product development focusing on unmet clinical need. The industry has rapidly emerged within the context of an ageing population and a global surge in healthcare spending. But the market remains fragmented. The split of consumer, purchaser and payer leads to clinical need driving demand for new product development. This demand contributes to potentially large profit margins mainly contained by regulatory burden and liability issues. Demographic trends, prevalence of diseases and a huge capacity to absorb technology have sustained near unparalleled growth. To stay in the market, incremental development over the short term is essentially aided by responsiveness to demand. Disruptive product development is now more likely to come from multinational companies, in an increasingly expensive, regulated industry. Understanding healthcare organization can help explain the highly complex process of diffusion of innovations in healthcare that include medical devices. The time has come for surgeons to become actively involved with all aspects of the medical device life cycle including commercial activity and post-market surveillance. This is vital for improving patient care and ensuring patient safety. © The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

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

HIV counseling and testing practices among clients presenting at a market HIV clinic in Kampala, Uganda: a cross-sectional study.

PubMed

Matovu, Joseph Kb; Bukuluki, Paul W; Mafigiri, David K; Mudondo, Harriet

2017-09-01

Uptake of HIV counseling and testing (HCT) among informal sector workers is not well documented. To assess HCT practices among clients presenting for HIV services at a market HIV clinic in Kampala, Uganda. Between August 1 and September 15, 2009, clients presenting for HIV services at a market HIV clinic were invited to participate in the study. Socio-demographic and HCT data were collected from consenting adults aged 16+ years. Descriptive statistics were performed using STATA version 14.1. Of 224 individuals who consented to the interview, n=139 62 % were market vendors while n=85 38 % were engaged in other market-related activities. Majority of the respondents, n=165, 73.7 %, had ever tested for HIV; of these, n=148,89.7 % had ever tested for 2+ times. The main reasons for repeat testing were the need to confirm previous HIV test results, n=126, 85.1% and the belief that the previous HIV test results were false, n=35, 23.6 %. Uptake of couples' HCT was low, n=63, 38.2 %, despite the fact that n=200, 89 % had ever heard of couples' HCT. These findings indicate high rates of repeat testing but low rates of couples' HCT uptake in this population.

Neighborhood drug markets: a risk environment for bacterial sexually transmitted infections among urban youth.

PubMed

Jennings, Jacky M; Taylor, Ralph B; Salhi, Rama A; Furr-Holden, C Debra M; Ellen, Jonathan M

2012-04-01

We hypothesized that neighborhoods with drug markets, as compared to those without, have a greater concentration of infected sex partners, i.e. core transmitters, and that in these areas, there is an increased risk environment for STIs. This study determined if neighborhood drug markets were associated with a high-risk sex partnership and, separately, with a current bacterial STI (chlamydia and/or gonorrhea) after controlling for individual demographic and sexual risk factors among a household sample of young people in Baltimore City, MD. Analyses also tested whether links were independent of neighborhood socioeconomic status. Data for this study were collected from a household study, systematic social observations and police arrest, public health STI surveillance and U.S. census data. Nonlinear multilevel models showed that living in neighborhoods with household survey-reported drug markets increased the likelihood of having a high-risk sex partnership after controlling for individual-level demographic factors and illicit drug use and neighborhood socioeconomic status. Further, living in neighborhoods with survey-reported drug markets increased the likelihood of having a current bacterial STI after controlling for individual-level demographic and sexual risk factors and neighborhood socioeconomic status. The results suggest that local conditions in neighborhoods with drug markets may play an important role in setting-up risk environments for high-risk sex partnerships and bacterial STIs. Patterns observed appeared dependent on the type of drug market indicator used. Future studies should explore how conditions in areas with local drug markets may alter sexual networks structures and whether specific types of drug markets are particularly important in determining STI risk. Copyright © 2012 Elsevier Ltd. All rights reserved.

Neighborhood Drug Markets: A risk environment for bacterial sexually transmitted infections among urban youth

PubMed Central

Jennings, Jacky M.; Taylor, Ralph B.; Salhi, Rama A.; Furr-Holden, C.Debra M.; Ellen, Jonathan M.

2012-01-01

We hypothesized that neighborhoods with drug markets, as compared to those without, have a greater concentration of infected sex partners, i.e. core transmitters, and that in these areas, there is an increased risk environment for STIs. This study determined if neighborhood drug markets were associated with a high-risk sex partnership and, separately, with a current bacterial STI (chlamydia and/or gonorrhea) after controlling for individual demographic and sexual risk factors among a household sample of young people in Baltimore City, MD. Analyses also tested whether links were independent of neighborhood socioeconomic status. Data for this study were collected from a household study, systematic social observations and police arrest, public health STI surveillance and U.S. census data. Nonlinear multilevel models showed that living in neighborhoods with household survey-reported drug markets increased the likelihood of having a high-risk sex partnership after controlling for individual level demographic factors and illicit drug use and neighborhood socioeconomic status. Further, living in neighborhoods with survey-reported drug markets increased the likelihood of having a current bacterial STI after controlling for individual level demographic and sexual risk factors and neighborhood socioeconomic status. The results suggest that local conditions in neighborhoods with drug markets may play an important role in setting-up risk environments for high-risk sex partnerships and bacterial STIs. Patterns observed appeared dependent on the type of drug market indicator used. Future studies should explore how conditions in areas with local drug markets may alter sexual networks structures and whether specific types of drug markets are particularly important in determining STI risk. PMID:22386616

Comparative assessment of passive surveillance in disease-free and endemic situation: Example of Brucella melitensis surveillance in Switzerland and in Bosnia and Herzegovina

PubMed Central

Hadorn, Daniela C; Haracic, Sabina Seric; Stärk, Katharina DC

2008-01-01

Background Globalization and subsequent growth in international trade in animals and animal products has increased the importance of international disease reporting. Efficient and reliable surveillance systems are needed in order to document the disease status of a population at a given time. In this context, passive surveillance plays an important role in early warning systems. However, it is not yet routinely integrated in the assessment of disease surveillance systems because different factors like the disease awareness (DA) of people reporting suspect cases influence the detection performance of passive surveillance. In this paper, we used scenario tree methodology in order to evaluate and compare the quality and benefit of abortion testing (ABT) for Brucella melitensis (Bm) between the disease free situation in Switzerland (CH) and a hypothetical disease free situation in Bosnia and Herzegovina (BH), taking into account DA levels assumed for the current endemic situation in BH. Results The structure and input parameters of the scenario tree were identical for CH and BH with the exception of population data in small ruminants and the DA in farmers and veterinarians. The sensitivity analysis of the stochastic scenario tree model showed that the small ruminant population structure and the DA of farmers were important influential parameters with regard to the unit sensitivity of ABT in both CH and BH. The DA of both farmers and veterinarians was assumed to be higher in BH than in CH due to the current endemic situation in BH. Although the same DA cannot necessarily be assumed for the modelled hypothetical disease free situation as for the actual endemic situation, it shows the importance of the higher vigilance of people reporting suspect cases on the probability that an average unit processed in the ABT-component would test positive. Conclusion The actual sensitivity of passive surveillance approaches heavily depends on the context in which they are applied

Comparative assessment of passive surveillance in disease-free and endemic situation: example of Brucella melitensis surveillance in Switzerland and in Bosnia and Herzegovina.

PubMed

Hadorn, Daniela C; Haracic, Sabina Seric; Stärk, Katharina D C

2008-12-22

Globalization and subsequent growth in international trade in animals and animal products has increased the importance of international disease reporting. Efficient and reliable surveillance systems are needed in order to document the disease status of a population at a given time. In this context, passive surveillance plays an important role in early warning systems. However, it is not yet routinely integrated in the assessment of disease surveillance systems because different factors like the disease awareness (DA) of people reporting suspect cases influence the detection performance of passive surveillance. In this paper, we used scenario tree methodology in order to evaluate and compare the quality and benefit of abortion testing (ABT) for Brucella melitensis (Bm) between the disease free situation in Switzerland (CH) and a hypothetical disease free situation in Bosnia and Herzegovina (BH), taking into account DA levels assumed for the current endemic situation in BH. The structure and input parameters of the scenario tree were identical for CH and BH with the exception of population data in small ruminants and the DA in farmers and veterinarians. The sensitivity analysis of the stochastic scenario tree model showed that the small ruminant population structure and the DA of farmers were important influential parameters with regard to the unit sensitivity of ABT in both CH and BH. The DA of both farmers and veterinarians was assumed to be higher in BH than in CH due to the current endemic situation in BH. Although the same DA cannot necessarily be assumed for the modelled hypothetical disease free situation as for the actual endemic situation, it shows the importance of the higher vigilance of people reporting suspect cases on the probability that an average unit processed in the ABT-component would test positive. The actual sensitivity of passive surveillance approaches heavily depends on the context in which they are applied. Scenario tree modelling allows for

Detection of imminent vein graft occlusion: what is the optimal surveillance program?

PubMed

Tinder, Chelsey N; Bandyk, Dennis F

2009-12-01

The prediction of infrainguinal vein bypass failure remains an inexact judgment. Patient demographics, technical factors, and vascular laboratory graft surveillance testing are helpful in identifying a high-risk graft cohort. The optimal surveillance program to detect the bypass at risk for imminent occlusion continues to be developed, but required elements are known and include clinical assessment for new or changes in limb ischemia symptoms, measurement of ankle and/or toe systolic pressure, and duplex ultrasound imaging of the bypass graft. Duplex ultrasound assessment of bypass hemodynamics may be the most accurate method to detect imminent vein graft occlusion. The finding of low graft flow during intraoperative assessment or at a scheduled surveillance study predicts failure; and if associated with an occlusive lesion, a graft revision can prolong patency. The most common abnormality producing graft failure is conduit stenosis caused by myointimal hyperplasia; and the majority can be repaired by an endovascular intervention. Frequency of testing to detect the failing bypass should be individualized to the patient, the type of arterial bypass, and prior duplex ultrasound scan findings. The focus of surveillance is on identification of the low-flow arterial bypass and timely repair of detected critical stenosis defined by duplex velocity spectra criteria of a peak systolic velocity 300 cm/s and peak systolic velocity ratio across the stenosis >3.5-correlating with >70% diameter-reducing stenosis. When conducted appropriately, a graft surveillance program should result in an unexpected graft failure rate of <3% per year.

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

PubMed

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. Also, 33.1 percent thought the hospital should be more involved in AIDS education. Finally, certain hospital characteristics,such as location and for-profit status, were not associated with support for hospital-based AIDS interventions. Contrary to what was

Citizen Science and Wildlife Disease Surveillance.

PubMed

Lawson, Becki; Petrovan, Silviu O; Cunningham, Andrew A

2015-12-01

Achieving effective wildlife disease surveillance is challenging. The incorporation of citizen science (CS) in wildlife health surveillance can be beneficial, particularly where resources are limited and cost-effectiveness is paramount. Reports of wildlife morbidity and mortality from the public facilitate large-scale surveillance, both in time and space, which would otherwise be financially infeasible, and raise awareness of incidents occurring on privately owned land. CS wildlife disease surveillance schemes benefit scientists, the participating public and wildlife alike. CS has been employed for targeted, scanning and syndromic surveillance of wildlife disease. Whilst opportunistic surveillance is most common, systematic observations enable the standardisation of observer effort and, combined with wildlife population monitoring schemes, can allow evaluation of disease impacts at the population level. Near-universal access to digital media has revolutionised reporting modalities and facilitated rapid and economical means of sharing feedback with participants. Here we review CS schemes for wildlife disease surveillance and highlight their scope, benefits, logistical considerations, financial implications and potential limitations. The need to adopt a collaborative and multidisciplinary approach to wildlife health surveillance is increasingly recognised and the general public can make a significant contribution through CS.