Validation of a Five Plate Test, the STAR protocol, for the screening of antibiotic residues in muscle from different animal species according to European Decision 2002/657/EC.

PubMed

Gaudin, V; Hedou, C; Rault, A; Verdon, E

2010-07-01

The STAR protocol is a Five Plate Test (FPT) developed several years ago at the Community Reference Laboratory (CRL) for the screening of antimicrobial residues in milk and muscle. This paper presents the validation of this method according to European Decision 2002/657/EC and to an internal guideline for validation. A validation protocol based on 'simulated tissues' and on a list of 16 representative antimicrobials to be validated was implemented in our laboratory during several months for the STAR protocol. The performance characteristics of the method were determined (specificity, detection capabilities CCbeta, applicability, ruggedness). In conclusion, the STAR protocol is applicable to the broad-spectrum detection of antibiotic residues in muscles of different animal species (pig, cattle, sheep, poultry). The method has good specificity (false-positive rate = 4%). The detection capabilities were determined for 16 antibiotics from different families in relation to their respective maximum residue limit (MRL): beta-lactams (penicillins and cephalosporins < or = MRL), tetracyclines (< or = MRL and < or = 2.5 MRL), macrolides (2 MRL), quinolones (< or = 2 MRL), some sulphonamides (< or = 3 MRL), and trimethoprim (2 MRL). However, the sensitivity of the STAR protocol towards aminoglycosides (> 8 MRL) and florfenicol (< or = 10 MRL) was unsatisfactory (>MRL). The two objectives of this study were met: firstly, to validate the STAR protocol according to European Decision 2002/657/EC, then to demonstrate that the validation guideline developed to implement this decision is applicable to microbiological plate tests even for muscle. The use of simulated tissue appeared a good compromise between spiked discs with antibiotic solutions and incurred tissues. In addition, the choice of a list of representative antibiotics allowed the reduction of the scope of the validation, which was already costly in time and effort.

Improving the accuracy of blood pressure measurement: the influence of the European Society of Hypertension International Protocol (ESH-IP) for the validation of blood pressure measuring devices and future perspectives.

PubMed

Stergiou, George S; Asmar, Roland; Myers, Martin; Palatini, Paolo; Parati, Gianfranco; Shennan, Andrew; Wang, Jiguang; O'Brien, Eoin

2018-03-01

The European Society of Hypertension (ESH) International Protocol (ESH-IP) for the validation of blood pressure (BP) measuring devices was published in 2002, with the main objective of simplifying the validation procedures, so that more BP monitors would be subjected to independent validation. This article provides an overview of the international impact of the ESH-IP and of the lessons learned from its use, to be able to justify further developments in validation protocols. A review of published (PubMed) validation studies from 2002 to 2017 was performed. One hundred and seventy-seven validation studies using the ESH-IP, 59 using the British Hypertension Society protocol, 46 using the Association for the Advancement of Medical Instrumentation (AAMI) standard and 23 using the International Organization for Standardization (ISO) standard were identified. Lists of validated office-clinic, home and ambulatory BP monitors are provided. Of the ESH-IP studies, 93% tested oscillometric devices, 80% upper arm, 71% home, 25% office and 7% ambulatory monitors (some had more than one function). The original goal of the ESH-IP has been fulfilled in that in the last decade the number of published validation studies has more than doubled. It is now recognized that the provision of accurate devices would be best served by having a universal protocol. An international initiative has been put in place by AAMI, ESH and ISO experts aiming to reach consensus for a universal validation protocol to be accepted worldwide, which will allow a more thorough evaluation of the accuracy and performance of future BP monitors.

The HoMedics BPA-200 and BPA-300 home blood pressure devices fail the European Society of Hypertension International Protocol and cannot be recommended for patient use.

PubMed

Grim, Clarence E; Grim, Carlene M

2008-08-01

We have tested two home blood pressure monitors made by the HoMedics, Inc., 300 Pontiac Trail, Commerce Township, Michigan 48390, USA, using the European Society of Hypertension International Protocol. Both failed and we believe it is important to get this into the literature quickly to protect patients and practitioners.

Validation of the Pangao PG-800B26 upper arm blood pressure monitor in the general population according to the European Society of Hypertension and the British Hypertension Society protocols.

PubMed

Chen, Liang; Li, Jiyu; Wen, Jing; Guo, Changfeng; Zhang, Jingying; Yu, Zhen

2018-02-01

This study aimed to evaluate the accuracy of the automated oscillometric upper arm blood pressure monitor Pangao PG-800B26 for home blood pressure monitoring according to the European Society of Hypertension International Protocol (ESH-IP) revision 2010 and the British Hypertension Society (BHS) protocols. Systolic and diastolic blood pressures were measured sequentially in 33 and 85 adults, respectively, on the basis of the ESH-IP and BHS protocols using a mercury sphygmomanometer (two observers) and the device (one supervisor). The procedures and analysis methods of the protocols were followed precisely. The device fulfilled the criteria of the ESH-IP, with device-observer differences of 1.01±5.16 and -0.58±4.17 mmHg for systolic and diastolic blood pressure, respectively. Furthermore, the A/A grade of the BHS protocol was also achieved for overall grading and for the three pressure levels, with average differences of 0.85±6.35 and -0.15±5.65 mmHg for systolic and diastolic blood pressure, respectively, which also fulfilled the requirements of the Association for the Advancement of Medical Instrumentation. The Pangao PG-800B26 fulfilled the criteria of the ESH-IP 2010 and achieved the A/A grade of the BHS protocol, and hence can be recommended for home use in adults.

Validation of the Pangao PG-800A36 automatic wrist blood pressure monitor according to the European Society of Hypertension and the British Hypertension Society protocols.

PubMed

Zhao, Hairong; Qiao, Weichang; Zhang, Rui; Cui, Peng; Hou, Fanglin; Zhang, Wenli

2018-02-01

The aim of this study was to validate the PG-800A36 automatic wrist blood pressure monitor according to the European Society of Hypertension International Protocol (ESH-IP) revision 2010 and the British Hypertension Society (BHS) protocols. A total of 33 participants were initially included on the basis of the ESH-IP, followed by examination of 85 participants according to the BHS protocol. The procedures and analysis methods of the protocols were followed precisely with left arm/wrist sequential measurements by two trained observers using a mercury sphygmomanometer and one supervisor using the device. The device passed the ESH-IP with an average difference of 1.45±6.46 mmHg for systolic blood pressure and 1.25±5.10 mmHg for diastolic blood pressure. Furthermore, the A/A grade of the BHS protocol was achieved with an average difference of 1.84±6.94 mmHg for systolic blood pressure and 1.15±6.49 mmHg for diastolic blood pressure, and thus, the device also fulfilled the requirements of the Association for the Advancement of Medical Instrumentation. The Pangao PG-800A36 passed the requirements of the ESH-IP revision 2010 and achieved the A/A grade of the BHS protocol, which can be recommended for self-measurement in the general population.

Validation of the A&D UM-201 device for office blood pressure measurement according to the European Society of Hypertension International Protocol Revision 2010.

PubMed

Fania, Claudio; Albertini, Federica; Palatini, Paolo

2017-08-01

The aim of this study was to determine the accuracy of the A&D UM-201 device coupled to several cuffs for different arm sizes for office blood pressure (BP) measurement according to the International Protocol of the European Society of Hypertension. Evaluation was carried out in 33 individuals. The mean age of the individuals was 59.3±13.2 years, systolic BP was 145.4±20.6 mmHg (range: 109-186 mmHg), diastolic BP was 87.3±18.0 mmHg (range: 50-124 mmHg), and arm circumference was 30.4±4.2 cm (range: 23-39 cm). The protocol requirements were followed precisely. The UM-201 monitor passed all requirements, fulfilling the standards of the protocol. On average, the device overestimated systolic BP by 3.0±2.1 mmHg and diastolic BP by 2.6±2.0 mmHg. These data show that the A&D UM-201 device coupled to several cuffs for different ranges of arm circumference fulfilled the requirements for validation by the International Protocol and can be recommended for clinical use in the adult population.

Validation of the A&D BP UB-542 wrist device for home blood pressure measurement according to the European Society of Hypertension International Protocol revision 2010.

PubMed

Saladini, Francesca; Benetti, Elisabetta; Fania, Claudio; Palatini, Paolo

2013-08-01

The objective of this study was to determine the accuracy of the A&D BP UB-542 wrist device for home blood pressure (BP) measurement according to the International Protocol of the European Society of Hypertension (ESH). Device evaluation was carried out in 33 patients. The mean age was 50.9±10.1 years, the mean systolic BP was 141.6±22.8 mmHg (range 92 : 189), the mean diastolic BP was 89.2±11.4 mmHg (range 62 : 120), the mean arm circumference was 28.8±3.2 cm (range 23-35), and the mean wrist circumference was 17.1±1.4 cm (range 14-19.5). The protocol requirements were followed precisely. The device passed all requirements, fulfilling the standards of the protocol. On average, the device overestimated the systolic BP by 1.8±7.2 mmHg and diastolic BP by 1.6±5.7 mmHg. These data show that the A&D BP UB-542 wrist device met the requirements for validation by the International Protocol and can be recommended for clinical use in the adult population.

Validation of the Pangao PG-800B11 blood pressure monitor according to the European Society of Hypertension and the British Hypertension Society protocols.

PubMed

Bing, Sen; Zhang, Cunhai; Wang, Liping; Li, Linyi; Wan, Yi

2014-12-01

The study aimed to determine the accuracy of the fully automated oscillometric upper-arm blood pressure (BP) monitor Pangao PG-800B11 according to the European Society of Hypertension-International Protocol (ESH-IP) revision 2010 and the British Hypertension Society (BHS) protocol 1993. Data from 33 participants were initially examined according to the ESH-IP revision 2010. Furthermore, 52 participants were then enrolled to fulfill the BHS protocol requirements. In all participants, sequential left arm measurements were performed by two trained observers using a mercury sphygmomanometer and one supervisor using the device. The protocols' requirements were followed precisely. The device passed all parts of the ESH protocol for systolic blood pressure (SBP) and diastolic blood pressure (DBP) and was graded A according to the criteria of the BHS protocol for both SBP and DBP. The A/A grade was achieved in low (<130/80 mmHg), medium (130-160/80-100 mmHg), and high (>160/100 mmHg) BP categories. The mean BP difference between PG-800B11 and observers in the 85 participants was -0.6±5.0 mmHg for SBP and -0.6±4.5 mmHg for DBP; thus, the device also fulfilled the requirements of the Association for the Advancement of Medical Instrumentation (AAMI). The Pangao PG-800B11 passed all requirements of the ESH-IP revision 2010 and achieved A/A grade of the BHS protocol across a wide range of BPs.

The European Innovation Partnership on Active and Healthy Ageing Synergies: Protocol for a Prospective Observational Study to Measure the Impact of a Community-Based Program on Prevention and Mitigation of Frailty (ICP - PMF) in Community-Dwelling Older Adults.

PubMed

Liotta, G; Orfila, F; Vollenbroek-Hutten, M; Roller-Winsberger, R; Illario, M; Musian, D; Alvino, S; O'Caoimh, R; Cano, A; Molloy, W; Iaccarino, G; Marazzi, M C; Inzerilli, M C; Madaro, O; Paul, C; Csonka, P; Vince, A C; Menditto, E; Maggio, M; Scarcella, P; Gilardi, F; Lucaroni, F; Abete, P; Girardi, V; Barra, R; Palombi, L

2016-11-01

Aim of this paper is to describe the protocol of the study "Impact of a Community-based Program on Prevention and Mitigation of Frailty in community-dwelling older adults" developed in the framework of the European Innovation Partnership on Active and Healthy Ageing. This proposal has been developed by the Partnership Action groups on frailty, fall prevention and polypharmacy in older. The proposal wants to assess the impact of community-based programs aimed to counteract three main outcomes related to frailty: hospitalization, institutionalization and death. Bringing together researchers from seven European countries, the proposal aims to achieve the critical mass and the geographical extension enough to provide information useful to all older European citizens. An observational study will be carried out to calculate the incidence of the different outcomes in relation to the various interventions that will be assessed; results will be compared with data coming from already established national, regional and local dataset using the observed/expected approach. The sample will be made up by at least 2000 citizens for each outcome. All the citizens will be assessed at the baseline with two multidimensional questionnaires: the RISC questionnaire and the Short Functional Geriatric Evaluation questionnaire. The outcomes will be assessed every six-twelve months.

Large-scale hydrological simulations using the soil water assessment tool, protocol development, and application in the danube basin.

PubMed

Pagliero, Liliana; Bouraoui, Fayçal; Willems, Patrick; Diels, Jan

2014-01-01

The Water Framework Directive of the European Union requires member states to achieve good ecological status of all water bodies. A harmonized pan-European assessment of water resources availability and quality, as affected by various management options, is necessary for a successful implementation of European environmental legislation. In this context, we developed a methodology to predict surface water flow at the pan-European scale using available datasets. Among the hydrological models available, the Soil Water Assessment Tool was selected because its characteristics make it suitable for large-scale applications with limited data requirements. This paper presents the results for the Danube pilot basin. The Danube Basin is one of the largest European watersheds, covering approximately 803,000 km and portions of 14 countries. The modeling data used included land use and management information, a detailed soil parameters map, and high-resolution climate data. The Danube Basin was divided into 4663 subwatersheds of an average size of 179 km. A modeling protocol is proposed to cope with the problems of hydrological regionalization from gauged to ungauged watersheds and overparameterization and identifiability, which are usually present during calibration. The protocol involves a cluster analysis for the determination of hydrological regions and multiobjective calibration using a combination of manual and automated calibration. The proposed protocol was successfully implemented, with the modeled discharges capturing well the overall hydrological behavior of the basin. Copyright © by the American Society of Agronomy, Crop Science Society of America, and Soil Science Society of America, Inc.

Validation of the Omron HEM-7320-LA, upper arm blood pressure monitor with Intelli Wrap Technology Cuff HEM-FL1 for self-measurement and clinic use according to the European Society of Hypertension International Protocol revision 2010 in the Mexican population.

PubMed

Grover-Páez, Fernando; Cardona-Muñoz, Ernesto G; Cardona-Müller, David; Guzmán-Saldívar, Víctor H; Rodríguez-De la Cerda, Mariana; Jiménez-Cázarez, Mayra B; Totsuka-Sutto, Sylvia E; Alanis-Sánchez, Guillermo A; Ramos-Becerra, Carlos G

2017-12-01

The aim of this study was to determine the accuracy of the Omron HEM-7320-LA with Intelli Wrap technology cuff HEM-FL1 for self-measurement and clinic blood pressure (BP) measurement according to the European Society of Hypertension International Protocol revision 2010. The evaluation was performed in 39 individuals. The mean age of the participants was 47.9±14 years; systolic BP was 145.2±24.3 mmHg (range: 97-190), diastolic BP was 90.9±12.9 mmHg (range: 68-120), and arm circumference was 30.8±4 cm (range: 25-38.5). The device successfully fulfilled the established criteria of the validation protocol. The device overestimated systolic BP by 0.6±5.7 mmHg and diastolic BP by 2.2±5.1 mmHg. The specially designed cuff HEM-FL1 to cover a broad range of arm circumferences and self-placement fulfilled the requirements of the International Protocol.

Validation of two automatic devices for self-measurement of blood pressure according to the International Protocol of the European Society of Hypertension: the Omron M6 (HEM-7001-E) and the Omron R7 (HEM 637-IT).

PubMed

Topouchian, Jirar A; El Assaad, Mohamed A; Orobinskaia, Ludmila V; El Feghali, Ramzi N; Asmar, Roland G

2006-06-01

Two electronic devices for self-measurement of blood pressure - a brachial monitor, the Omron M6, and a wrist monitor, the Omron R7 - were evaluated in two separate studies according to the International Protocol of the European Society of Hypertension. The International Validation Protocol is divided into two phases: the first phase is performed on 15 selected participants (45 pairs of blood pressure measurements); if the device passes this phase, 18 supplementary participants are included (54 pairs of blood pressure measurements) making a total number of 33 participants (99 pairs of blood pressure measurements) on whom the final validation is performed. The same methodology recommended by the European Society of Hypertension protocol was applied for both studies. In each study and for each participant, four blood pressure measurements were taken simultaneously by two trained observers using mercury sphygmomanometers alternately with three measurements taken by the tested device. The difference between the blood pressure value given by the device and that obtained by the two observers (mean of the two observers) was calculated for each measure. The 99 pairs of blood pressure differences were classified into three categories (

Validation of the Andon KD-5965 upper-arm blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010.

PubMed

Huang, Jinhua; Li, Zhijie; Li, Guimei; Liu, Zhaoying

2015-10-01

This study aimed to evaluate the accuracy of the Andon KD-5965 upper-arm blood pressure monitor according to the European Society of Hypertension International Protocol revision 2010. Systolic and diastolic blood pressures were sequentially measured in 33 adults, with 20 women using a mercury sphygmomanometer (two observers) and the Andon KD-5965 device (one supervisor). A total of 99 pairs of comparisons were obtained from 33 participants for judgments in two parts with three grading phases. The device achieved the targets in part 1 of the validation study. The number of absolute differences between the device and observers within 5, 10, and 15 mmHg was 70/99, 91/99, and 98/99, respectively, for systolic blood pressure and 81/99, 99/99, and 99/99, respectively, for diastolic blood pressure. The device also fulfilled the criteria in part 2 of the validation study. Twenty-five and 29 participants, for systolic and diastolic blood pressure, respectively, had at least two of the three device-observers differences within 5 mmHg (required≥24). Two and one participants for systolic and diastolic blood pressure, respectively, had all three device-observers comparisons greater than 5 mmHg. According to the validation results, with better performance for diastolic blood pressure than that for systolic blood pressure, the Andon automated oscillometric upper-arm blood pressure monitor KD-5965 fulfilled the requirements of the European Society of Hypertension International Protocol revision 2010, and hence can be recommended for blood pressure measurement in adults.

CT protocols in interstitial lung diseases--a survey among members of the European Society of Thoracic Imaging and a review of the literature.

PubMed

Prosch, Helmut; Schaefer-Prokop, Cornelia M; Eisenhuber, Edith; Kienzl, Daniela; Herold, Christian J

2013-06-01

The aim of this study was to survey the current CT protocols used by members of the European Society of Thoracic Imaging (ESTI) to evaluate patients with interstitial lung diseases (ILD). A questionnaire was e-mailed to 173 ESTI members. The survey focussed on CT acquisition and reconstruction techniques. In particular, questions referred to the use of discontinuous HRCT or volume CT protocols, the acquisition of additional acquisitions in expiration or in the prone position, and methods of radiation dose reduction and on reconstruction algorithms. The overall response rate was 37 %. Eighty-five percent of the respondents used either volume CT alone or in combination with discontinuous HRCT. Forty-five percent of the respondents adapt their CT protocols to the patient's weight and/or age. Expiratory CT or CT in the prone position was performed by 58 % and 59 % of the respondents, respectively. The number of reconstructed series ranged from two to eight. Our survey showed that radiologists with a special interest and experience in chest radiology use a variety of CT protocols for the evaluation of ILD. There is a clear preference for volumetric scans and a strong tendency to use the 3D information. • Experienced thoracic radiologists use various CT protocols for evaluating interstitial lung diseases. • Most workers prefer volumetric CT acquisitions, making use of the 3D information • More attention to reducing the radiation dose appears to be needed.

Validation of the SEJOY BP-1307 upper-arm blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010.

PubMed

Lei, Lei; Chen, Yi; Chen, Qi; Li, Yan; Wang, Ji-Guang

2017-12-01

The present study aimed to evaluate the accuracy of the automated oscillometric upper-arm blood pressure monitor SEJOY BP-1307 (also called JOYTECH DBP-1307) for home blood pressure monitoring according to the International Protocol of the European Society of Hypertension revision 2010. Systolic and diastolic blood pressures were sequentially measured in 33 adult Chinese individuals (13 women, 45.1 years of mean age) using a mercury sphygmomanometer (two observers) and the SEJOY BP-1307 device (one supervisor). Ninety-nine pairs of comparisons were obtained from 33 participants for judgments in two parts with three grading phases. The average±SD of the device-observer differences was 0.2±4.1 and -1.7±4.7 mmHg for systolic and diastolic blood pressure, respectively. The SEJOY BP-1307 device achieved the criteria in both part 1 and part 2 of the validation study. The SEJOY upper-arm blood pressure monitor BP-1307 has passed the requirements of the International Protocol revision 2010, and hence can be recommended for home use in adults.

Validation of the Omron M3 Intellisense (HEM-7051-E) upper arm blood pressure monitor, for self-measurement, according to the European Society of Hypertension International Protocol revision 2010 in a stage 3-5 chronic kidney disease population.

PubMed

Akpolat, Tekin; Erdem, Emre; Aydogdu, Türkan

2012-01-01

Encouragement of home blood pressure (BP) monitoring has a great potential to improve hypertension control rates. The purpose of this study was to test validation of the Omron M3 Intellisense (HEM-7051-E) upper arm BP measuring monitor for self-measurement according to the European Society of Hypertension International Protocol revision 2010 (ESH-IP2) in stage 3-5 chronic kidney disease (CKD) patients. 66 patients having CKD stage 3-5 were included in the study. Nine consecutive measurements were made according to the ESH-IP2 protocol. The Omron M3 Intellisense device fulfills the validation criteria of the ESH-IP2 for stage 3-5 CKD patients. Although arterial stiffness can affect accurate BP measurement, there are limited data regarding the use of automated oscillometric devices in CKD. To our knowledge, this is the first study investigating validation of an oscillometric device in stage 3-5 predialysis CKD patients. This study validates the Omron M3 Intellisense upper arm device for stage 3-5 CKD patients. New validation studies investigating other oscillometric sphygmomanometers for CKD patients and involvement of nephrologists in these studies have great potential to increase patient care in CKD. Copyright © 2011 S. Karger AG, Basel.

Validation of the Pangao PG-800B5 for clinical use and self-measurement according to the European Society of Hypertension International Protocol revision 2010.

PubMed

Chen, Wan; Zeng, Zhaolin; Li, Lizhi; Wan, Xiaofen; Wan, Yi

2014-10-01

This study aimed to validate the Pangao PG-800B5 upper arm blood pressure monitor according to the European Society of Hypertension International Protocol revision 2010. A total of 33 participants, 16 men and 17 women, were included in the device evaluation. The protocol requirements were followed precisely. The mean age of the participants was 56.4±21.0 years (range 22-84 years). The mean systolic blood pressure was 143.6±25.5 mmHg (range 98-188 mmHg), the mean diastolic blood pressure was 85.7±17.2 mmHg (range 49-125 mmHg), and the mean arm circumference was 26.1±2.2 cm (range 23-32 cm). On average, the device overestimated the systolic blood pressure by 0.9±4.2 mmHg and diastolic blood pressure by 0.7±4.5 mmHg. The device passed all requirements, fulfilling the standards of the protocol. Therefore, the Pangao PG-800B5 upper arm blood pressure monitor can be recommended for clinical use and self-measurement in an adult population.

Time Trends of Period Prevalence Rates of Patients with Inhaled Long-Acting Beta-2-Agonists-Containing Prescriptions: A European Comparative Database Study

PubMed Central

Rottenkolber, Marietta; Voogd, Eef; van Dijk, Liset; Primatesta, Paola; Becker, Claudia; Schlienger, Raymond; de Groot, Mark C. H.; Alvarez, Yolanda; Durand, Julie; Slattery, Jim; Afonso, Ana; Requena, Gema; Gil, Miguel; Alvarez, Arturo; Hesse, Ulrik; Gerlach, Roman; Hasford, Joerg; Fischer, Rainald; Klungel, Olaf H.; Schmiedl, Sven

2015-01-01

Background Inhaled, long-acting beta-2-adrenoceptor agonists (LABA) have well-established roles in asthma and/or COPD treatment. Drug utilisation patterns for LABA have been described, but few studies have directly compared LABA use in different countries. We aimed to compare the prevalence of LABA-containing prescriptions in five European countries using a standardised methodology. Methods A common study protocol was applied to seven European healthcare record databases (Denmark, Germany, Spain, the Netherlands (2), and the UK (2)) to calculate crude and age- and sex-standardised annual period prevalence rates (PPRs) of LABA-containing prescriptions from 2002–2009. Annual PPRs were stratified by sex, age, and indication (asthma, COPD, asthma and COPD). Results From 2002–2009, age- and sex-standardised PPRs of patients with LABA-containing medications increased in all databases (58.2%–185.1%). Highest PPRs were found in men ≥ 80 years old and women 70–79 years old. Regarding the three indications, the highest age- and sex-standardised PPRs in all databases were found in patients with “asthma and COPD” but with large inter-country variation. In those with asthma or COPD, lower PPRs and smaller inter-country variations were found. For all three indications, PPRs for LABA-containing prescriptions increased with age. Conclusions Using a standardised protocol that allowed direct inter-country comparisons, we found highest rates of LABA-containing prescriptions in elderly patients and distinct differences in the increased utilisation of LABA-containing prescriptions within the study period throughout the five European countries. PMID:25706152

European Network of Bipolar Research Expert Centre (ENBREC): a network to foster research and promote innovative care.

PubMed

Henry, Chantal; Andreassen, Ole A; Barbato, Angelo; Demotes-Mainard, Jacques; Goodwin, Guy; Leboyer, Marion; Vieta, Eduard; Nolen, Willem A; Kessing, Lars Vedel; Scott, Jan; Bauer, Michael

2013-01-01

Bipolar disorders rank as one of the most disabling illnesses in working age adults worldwide. Despite this, the quality of care offered to patients with this disorder is suboptimal, largely due to limitations in our understanding of the pathology. Improving this scenario requires the development of a critical mass of expertise and multicentre collaborative projects. Within the framework of the European FP7 programme, we developed a European Network of Bipolar Research Expert Centres (ENBREC) designed specifically to facilitate EU-wide studies. ENBREC provides an integrated support structure facilitating research on disease mechanisms and clinical outcomes across six European countries (France, Germany, Italy, Norway, Spain and the UK). The centres are adopting a standardised clinical assessment that explores multiple aspects of bipolar disorder through a structured evaluation designed to inform clinical decision-making as well as being applicable to research. Reliable, established measures have been prioritised, and instruments have been translated and validated when necessary. An electronic healthcare record and monitoring system (e-ENBREC©) has been developed to collate the data. Protocols to conduct multicentre clinical observational studies and joint studies on cognitive function, biomarkers, genetics, and neuroimaging are in progress; a pilot study has been completed on strategies for routine implementation of psycho-education. The network demonstrates 'proof of principle' that expert centres across Europe can collaborate on a wide range of basic science and clinical programmes using shared protocols. This paper is to describe the network and how it aims to improve the quality and effectiveness of research in a neglected priority area.

Validation of four automatic devices for self-measurement of blood pressure according to the international protocol of the European Society of Hypertension.

PubMed

Topouchian, Jirar; Agnoletti, Davide; Blacher, Jacques; Youssef, Ahmed; Ibanez, Isabel; Khabouth, Jose; Khawaja, Salwa; Beaino, Layale; Asmar, Roland

2011-01-01

Four oscillometric devices for self-measurement of blood pressure (SBPM) were evaluated according to the European Society of Hypertension (ESH) international protocol and its 2010 revision in four separate studies. The Omron® M2, Omron M3, and Omron M6 measure blood pressure (BP) at the brachial level, while the Omron R2 measures BP at the wrist level. The international protocol requires a total number of 33 subjects in which the validation is performed. The Omron M2 and Omron R2 were validated in 2009 according to the ESH international protocol, while the Omron M3 and Omron M6 were validated in 2010-2011 according to the 2010 ESH international protocol revision. The protocol procedures were followed precisely. All four tested devices passed the validation process. The mean differences between the device and mercury readings were 2.7 ± 5.0 and -1.4 ± 3.2 mmHg for systolic and diastolic BP, respectively, using the Omron M2 device, and 1.7 ± 3.2 and -0.9 ± 2.6 mmHg using the Omron M3, 1.6 ± 2.9 and -0.9 ± 2.5 mmHg using the Omron M6, and -1.1 ± 4.8 and -0.9 ± 4.3 mmHg using the Omron R2. Readings from the Omron M2, Omron M3, Omron M6, and Omron R2, differing by less than 5, 10, and 15 mmHg, fulfill the ESH international protocol and its 2010 revision requirements. Therefore, each of these four devices can be used by patients for SBPM.

European emissions of the powerful greenhouse gases hydrofluorocarbons inferred from atmospheric measurements and their comparison with annual national reports to UNFCCC

NASA Astrophysics Data System (ADS)

Graziosi, F.; Arduini, J.; Furlani, F.; Giostra, U.; Cristofanelli, P.; Fang, X.; Hermanssen, O.; Lunder, C.; Maenhout, G.; O'Doherty, S.; Reimann, S.; Schmidbauer, N.; Vollmer, M. K.; Young, D.; Maione, M.

2017-06-01

Hydrofluorocarbons are powerful greenhouse gases developed by industry after the phase-out of the ozone depleting chlorofluorocarbons and hydrochlorofluorocarbons required by the Montreal Protocol. The climate benefit of reducing the emissions of hydrofluorocarbons has been widely recognised, leading to an amendment of the Montreal Protocol (Kigali Amendment) calling for developed countries to start to phase-down hydrofluorocarbons by 2019 and in developing countries to follow with a freeze between 2024 and 2028. In this way, nearly half a degree Celsius of warming would be avoided by the end of the century. Hydrofluorocarbons are also included in the basket of gases controlled under the Kyoto Protocol of the United Nations Framework Convention on Climate Change. Annex I parties to the Convention submit annual national greenhouse gas inventories based on a bottom-up approach, which relies on declared anthropogenic activities. Top-down methodologies, based on atmospheric measurements and modelling, can be used in support to the inventory compilation. In this study we used atmospheric data from four European sites combined with the FLEXPART dispersion model and a Bayesian inversion method, in order to derive emissions of nine individual hydrofluorocarbons from the whole European Geographic Domain and from twelve regions within it, then comparing our results with the annual emissions that the European countries submit every year to the United Nations Framework Convention on Climate Change, as well as with the bottom-up Emissions Database for Global Atmospheric Research. We found several discrepancies when considering the specific compounds and on the country level. However, an overall agreement is found when comparing European aggregated data, which between 2008 and 2014 are on average 84.2 ± 28.0 Tg-CO2-eq·yr-1 against the 95.1 Tg-CO2-eq·yr-1 reported by UNFCCC in the same period. Therefore, in agreement with other studies, the gap on the global level between bottom-up estimates of Annex I countries and total global top-down emissions should be essentially due to emissions from non-reporting countries (non-Annex I).

Validation of the A&D UM-211 device for office blood pressure measurement according to the European Society of Hypertension International Protocol revision 2010.

PubMed

Fania, Claudio; Albertini, Federica; Palatini, Paolo

2017-10-01

The aim of this study was to define the accuracy of UM-211, an automated oscillometric device for office use coupled to several cuffs for different arm sizes, according to the International Protocol of the European Society of Hypertension. The validation was performed in 33 individuals. Their mean age was 59.6±12.9 years, systolic blood pressure (BP) was 144.3±21.5 mmHg (range: 96-184 mmHg), diastolic BP was 86.8±18.5 mmHg (range: 48-124 mmHg), and arm circumference was 30.2±4.3 cm (range: 23-39 cm). Four sequential readings were taken by observers 1 and 2 using a double-headed stethoscope and a mercury sphygmomanometer, whereas three BP readings were taken by the supervisor using the test instrument. The differences between the readings provided by the device and the mean observer measurements were calculated. Therefore, each device measurement was compared with the previous and the next mean observer measurement. The validation results fulfilled all the 2010 European Society of Hypertension revision Protocol criteria for the general population and passed all validation grades. On average, the device overestimated systolic BP by 1.7±2.4 mmHg and diastolic BP by 1.7±2.5 mmHg. These data show that the UM-211 device coupled to several cuffs for different ranges of arm circumference met the requirements for validation according to the International Protocol and can be recommended for clinical use in the adult population. However, these results mainly apply to the use of the 22-32 and the 31-45 cm cuffs.

Patient doses from CT examinations in Turkey.

PubMed

Ataç, Gökçe Kaan; Parmaksız, Aydın; İnal, Tolga; Bulur, Emine; Bulgurlu, Figen; Öncü, Tolga; Gündoğdu, Sadi

2015-01-01

We aimed to establish the first diagnostic reference levels (DRLs) for computed tomography (CT) examinations in adult and pediatric patients in Turkey and compare these with international DRLs. CT performance information and examination parameters (for head, chest, high-resolution CT of the chest [HRCT-chest], abdominal, and pelvic protocols) from 1607 hospitals were collected via a survey. Dose length products and effective doses for standard patient sizes were calculated from the reported volume CT dose index (CTDIvol). The median number of protocols reported from the 167 responding hospitals (10% response rate) was 102 across five different age groups. Third quartile CTDIvol values for adult pelvic and all pediatric body protocols were higher than the European Commission standards but were comparable to studies conducted in other countries. The radiation dose indicators for adult patients were similar to those reported in the literature, except for those associated with head protocols. CT protocol optimization is necessary for adult head and pediatric chest, HRCT-chest, abdominal, and pelvic protocols. The findings from this study are recommended for use as national DRLs in Turkey.

European trauma guideline compliance assessment: the ETRAUSS study.

PubMed

Hamada, Sophie Rym; Gauss, Tobias; Pann, Jakob; Dünser, Martin; Leone, Marc; Duranteau, Jacques

2015-12-08

Haemorrhagic shock is the leading cause of preventable death in trauma patients. The 2013 European trauma guidelines emphasise a comprehensive, multidisciplinary, protocol-based approach to trauma care. The aim of the present Europe-wide survey was to compare 2015 practice with the 2013 guidelines. A group of members of the Trauma and Emergency Medicine section of the European Society of Intensive Care Medicine developed a 50-item questionnaire based upon the core recommendations of the 2013 guidelines, employing a multistep approach. The questionnaire covered five fields: care structure and organisation, haemodynamic resuscitation targets, fluid management, transfusion and coagulopathy, and haemorrhage control. The sampling used a two-step approach comprising initial purposive sampling of eminent trauma care providers in each European country, followed by snowball sampling of a maximum number of trauma care providers. A total of 296 responses were collected, 243 (81 %) from European countries. Those from outside the European Union were excluded from the analysis. Approximately three-fourths (74 %) of responders were working in a designated trauma centre. Blunt trauma predominated, accounting for more than 90 % of trauma cases. Considerable heterogeneity was observed in all five core aspects of trauma care, along with frequent deviations from the 2013 guidelines. Only 92 (38 %) of responders claimed to comply with the recommended systolic blood pressure target, and only 81 (33 %) responded that they complied with the target pressure in patients with traumatic brain injury. Crystalloid use was predominant (n = 209; 86 %), and vasopressor use was frequent (n = 171, 76 %) but remained controversial. Only 160 respondents (66 %) declared that they used tranexamic acid always or often. This is the first European trauma survey, to our knowledge. Heterogeneity is significant across centres with regard to the clinical protocols for trauma patients and as to locally available resources. Deviations from guidelines are frequent, differ from region to region and are dependent upon specialty training. Further efforts are required to provide consensus guidelines and to improve their implementation across European countries.

Validation of the Andon KD5031 for clinical use and self-measurement according to the European Society of Hypertension International Protocol.

PubMed

Wu, Ning; Zhang, Xuezhong; Wang, Wen; Zhang, Hongye

2016-10-01

This study aimed to evaluate the accuracy of the automated oscillometric upper arm blood pressure (BP) monitor Andon KD5031 for home BP monitoring according to the European Society of Hypertension International Protocol revision 2010. Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were sequentially measured in 33 participants using the standard mercury sphygmomanometer and the Andon KD5031 device. Ninety-nine pairs of comparisons were obtained from 33 participants for analysis. The KD5031 device achieved the targets in part 1 of the validation study. The number of absolute differences between the device and the observers within a range of 5, 10, and 15 mmHg was 66/99, 93/99, and 98/99, respectively, for SBP and 72/99, 94/99, and 99/99, respectively, for DBP. The device also achieved the targets in part 2 of the validation study. Twenty-six participants for both SBP and DBP had at least two of the three device-observer differences within 5 mmHg (required ≥24). The number of participants without a device-observer difference within 5 mmHg was one for SBP and three for DBP (required ≤3). The Andon upper arm BP monitor KD5031 has passed the International Protocol requirements, and it can be recommended for clinical use and self-measurement in adults.

Validation of the Andon KD595 for clinical use and self-measurement according to the European Society of Hypertension International Protocol.

PubMed

Wu, Ning; Zhang, Xuezhong; Wang, Wen; Zhang, Hongye

2016-04-01

This study aimed to evaluate the accuracy of the automated oscillometric upper arm blood pressure monitor Andon KD595 for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010. Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were sequentially measured in 33 participants using the standard mercury sphygmomanometer and the Andon KD595 device. Ninety-nine pairs of comparisons were obtained from 33 participants for analysis. The KD595 device achieved the targets in part 1 of the validation study. The number of absolute differences between the device and the observers within a range of 5, 10, and 15 mmHg was 72/99, 93/99, and 96/99, respectively, for SBP and 72/99, 96/99, and 99/99, respectively, for DBP. The device also achieved the targets in part 2 of the validation study. A total of 28 and 25 participants had at least two of the three device-observer differences within 5 mmHg (required≥24) for SBP and DBP, respectively. The number of participants without device-observer difference within 5 mmHg was two for SBP and two for DBP (required≤3). The Andon upper arm blood pressure monitor KD595 has passed the International Protocol requirements and it can be recommended for clinical use and self-measurement in adults.

Performance of the Colson MAM BP 3AA1-2 automatic blood pressure monitor according to the European Society of Hypertension validation protocol.

PubMed

Pereira, Telmo; Maldonado, João

2005-11-01

To evaluate the performance of the Colson MAM BP 3AA1-2 oscillometric automatic blood pressure monitor according to the validation protocol of the European Society of Hypertension, testing its suitability for self-measurement of blood pressure. The performance of the device was assessed in relation to various clinical variables, including age, gender, body mass index, arm circumference and arterial stiffness. 33 subjects (15 men and 18 women), with a mean age of 47 +/- 10 years, were studied according to the procedures laid down in the European Society of Hypertension validation protocol. Sequential same-arm blood pressure measurements were made, alternating between a mercury standard and the automatic device. The differences among the test-control measurements were assessed and divided into categorization zones of 5, 10 and 15 mmHg discrepancy. Aortic pulse wave velocity was assessed in all subjects with a Complior device (Colson, Paris). The Colson MAM BP 3AA1-2 passed all three phases of the protocol for both systolic and diastolic blood pressure. The mean differences between the test and control measurements were -1.0 +/- 5.0 mmHg for systolic blood pressure and -1.1 +/- 4.1 mmHg for diastolic blood pressure. Both standard deviations are well below the 8 mmHg limit proposed by the Association for the Advancement of Medical Instrumentation. The predictive value of various clinical variables for the discrepancies was assessed by a regression model analysis, with no variable being found that independently undermined the performance of the monitor. In another regression analysis, we found a similar relation between test and control blood pressures and aortic pulse wave velocity, a widely recognized and validated index of target organ damage. These data show that the Colson MAM BP 3AA1-2 satisfies the quality requirements proposed by the European Society of Hypertension, demonstrating its suitability for inclusion in integrated programs of clinical surveillance based on self-measurement of blood pressure. The uniformity of its performance over a wide spectrum of clinical characteristics and the relation found with pulse wave velocity further reinforce its clinical validity.

Validation of the Tensoval Duo Control II blood pressure monitor for clinic use and self-measurement according to the British Hypertension Society protocol and the European Society of Hypertension International Protocol Revision 2010.

PubMed

de Greeff, Annemarie; Shennan, Andrew H

2013-06-01

The Tensoval Duo Control II is an automated upper arm device that uses a combination of oscillometric and auscultatory technology to determine blood pressure noninvasively. The accuracy of this device was assessed according to the British Hypertension Society (BHS) protocol and the European Society of Hypertension International Protocol revision 2010 (ESH-IP2) in an adult population. Ethical approval was obtained. Eighty-five and 33 adult individuals, respectively, were recruited to fulfil the requirements of each protocol. Trained observers took nine sequential same-arm measurements alternating between a mercury sphygmomanometer and the device. The device had to achieve at least a B grade for both systolic and diastolic pressures to pass the BHS protocol and had to fulfil the criteria of all three phases of the ESH-IP2 protocol to receive recommendation. The device achieved an A/A grading for the BHS protocol and passed all three phases of the ESH-IP2 protocol. The mean difference±SD for the BHS/ESH protocols, respectively, was -1.8±6.5/-0.7±5.7 mmHg for systolic pressure and 1.9±5.1/2.4±4.5 mmHg for diastolic pressure. The device maintained its A/A grading throughout the low-pressure, medium-pressure and high-pressure ranges. The Tensoval Duo Control II device is recommended for clinical and home use according to both the BHS and the ESH-IP2 standard.

Applying the Intervention Mapping protocol to develop a kindergarten-based, family-involved intervention to increase European preschool children's physical activity levels: the ToyBox-study.

PubMed

De Craemer, M; De Decker, E; De Bourdeaudhuij, I; Verloigne, M; Duvinage, K; Koletzko, B; Ibrügger, S; Kreichauf, S; Grammatikaki, E; Moreno, L; Iotova, V; Socha, P; Szott, K; Manios, Y; Cardon, G

2014-08-01

Although sufficient physical activity is beneficial for preschoolers' health, activity levels in most preschoolers are low. As preschoolers spend a considerable amount of time at home and at kindergarten, interventions should target both environments to increase their activity levels. The aim of the current paper was to describe the six different steps of the Intervention Mapping protocol towards the systematic development and implementation of the physical activity component of the ToyBox-intervention. This intervention is a kindergarten-based, family-involved intervention implemented across six European countries. Based on the results of literature reviews and focus groups with parents/caregivers and kindergarten teachers, matrices of change objectives were created. Then, theory-based methods and practical strategies were selected to develop intervention materials at three different levels: (i) individual level (preschoolers); (ii) interpersonal level (parents/caregivers) and (iii) organizational level (teachers). This resulted in a standardized intervention with room for local and cultural adaptations in each participating country. Although the Intervention Mapping protocol is a time-consuming process, using this systematic approach may lead to an increase in intervention effectiveness. The presented matrices of change objectives are useful for future programme planners to develop and implement an intervention based on the Intervention Mapping protocol to increase physical activity levels in preschoolers. © 2014 World Obesity.

Validation of the Medisana MTP Plus upper arm blood pressure monitor, for self-measurement, according to the European Society of Hypertension International Protocol revision 2010.

PubMed

Erdem, Emre; Aydogdu, Türkan; Akpolat, Tekin

2011-02-01

Standard validation protocols are objective guides for healthcare providers, physicians, and patients. The purpose of this study was to test validation of the Medisana MTP Plus upper arm blood pressure (BP) measuring monitor for self-measurement according to the European Society of Hypertension International Protocol (ESH-IP2) in adults. The Medisana MTP Plus monitor is an automated and oscillometric upper arm device for home BP monitoring. Nine consecutive measurements were made according to the ESH-IP2. Overseen by an independent supervisor, measurements were recorded by two observers blinded from both each other's readings and from the device readings. The Medisana MTP Plus device fulfills the validation criteria of the ESH-IP2 for the general population. The mean (standard deviation) of the difference between the observers and the device measurements was 0.6 mmHg (5.1 mmHg) for systolic and 2.7 mmHg (3.4 mmHg) for diastolic pressures, respectively. As the Medisana MTP Plus device has achieved the required standards, it is recommended for home BP monitoring in an adult population.

Assembling and auditing a comprehensive DNA barcode reference library for European marine fishes.

PubMed

Oliveira, L M; Knebelsberger, T; Landi, M; Soares, P; Raupach, M J; Costa, F O

2016-12-01

A large-scale comprehensive reference library of DNA barcodes for European marine fishes was assembled, allowing the evaluation of taxonomic uncertainties and species genetic diversity that were otherwise hidden in geographically restricted studies. A total of 4118 DNA barcodes were assigned to 358 species generating 366 Barcode Index Numbers (BIN). Initial examination revealed as much as 141 BIN discordances (more than one species in each BIN). After implementing an auditing and five-grade (A-E) annotation protocol, the number of discordant species BINs was reduced to 44 (13% grade E), while concordant species BINs amounted to 271 (78% grades A and B) and 14 other had insufficient data (grade D). Fifteen species displayed comparatively high intraspecific divergences ranging from 2·6 to 18·5% (grade C), which is biologically paramount information to be considered in fish species monitoring and stock assessment. On balance, this compilation contributed to the detection of 59 European fish species probably in need of taxonomic clarification or re-evaluation. The generalized implementation of an auditing and annotation protocol for reference libraries of DNA barcodes is recommended. © 2016 The Fisheries Society of the British Isles.

Study protocol for examining job strain as a risk factor for severe unipolar depression in an individual participant meta-analysis of 14 European cohorts.

PubMed

Madsen, Ida E H; Hannerz, Harald; Nyberg, Solja T; Magnusson Hanson, Linda L; Ahola, Kirsi; Alfredsson, Lars; Batty, G David; Bjorner, Jakob B; Borritz, Marianne; Burr, Hermann; Dragano, Nico; Ferrie, Jane E; Hamer, Mark; Jokela, Markus; Knutsson, Anders; Koskenvuo, Markku; Koskinen, Aki; Leineweber, Constanze; Nielsen, Martin L; Nordin, Maria; Oksanen, Tuula; Pejtersen, Jan H; Pentti, Jaana; Salo, Paula; Singh-Manoux, Archana; Suominen, Sakari; Theorell, Töres; Toppinen-Tanner, Salla; Vahtera, Jussi; Väänänen, Ari; Westerholm, Peter J M; Westerlund, Hugo; Fransson, Eleonor; Heikkilä, Katriina; Virtanen, Marianna; Rugulies, Reiner; Kivimäki, Mika

2013-01-01

Previous studies have shown that gainfully employed individuals with high work demands and low control at work (denoted "job strain") are at increased risk of common mental disorders, including depression. Most existing studies have, however, measured depression using self-rated symptom scales that do not necessarily correspond to clinically diagnosed depression. In addition, a meta-analysis from 2008 indicated publication bias in the field.   This study protocol describes the planned design and analyses of an individual participant data meta-analysis, to examine whether job strain is associated with an increased risk of clinically diagnosed unipolar depression based on hospital treatment registers.  The study will be based on data from approximately 120,000 individuals who participated in 14 studies on work environment and health in 4 European countries. The self-reported working conditions data will be merged with national registers on psychiatric hospital treatment, primarily hospital admissions. Study-specific risk estimates for the association between job strain and depression will be calculated using Cox regressions. The study-specific risk estimates will be pooled using random effects meta-analysis.   The planned analyses will help clarify whether job strain is associated with an increased risk of clinically diagnosed unipolar depression. As the analysis is based on pre-planned study protocols and an individual participant data meta-analysis, the pooled risk estimates will not be influenced by selective reporting and publication bias. However, the results of the planned study may only pertain to severe cases of unipolar depression, because of the outcome measure applied.

The European Centre for Disease Prevention and Control (ECDC) pilot point prevalence survey of healthcare-associated infections and antimicrobial use.

PubMed

Zarb, P; Coignard, B; Griskeviciene, J; Muller, A; Vankerckhoven, V; Weist, K; Goossens, Mm; Vaerenberg, S; Hopkins, S; Catry, B; Monnet, Dl; Goossens, H; Suetens, C

2012-11-15

A standardised methodology for a combined point prevalence survey (PPS) on healthcare-associated infections (HAIs) and antimicrobial use in European acute care hospitals developed by the European Centre for Disease Prevention and Control was piloted across Europe. Variables were collected at national, hospital and patient level in 66 hospitals from 23 countries. A patient-based and a unit-based protocol were available. Feasibility was assessed via national and hospital questionnaires. Of 19,888 surveyed patients, 7.1% had an HAI and 34.6% were receiving at least one antimicrobial agent. Prevalence results were highest in intensive care units, with 28.1% patients with HAI, and 61.4% patients with antimicrobial use. Pneumonia and other lower respiratory tract infections (2.0% of patients; 95% confidence interval (CI): 1.8–2.2%) represented the most common type (25.7%) of HAI. Surgical prophylaxis was the indication for 17.3% of used antimicrobials and exceeded one day in 60.7% of cases. Risk factors in the patient-based protocol were provided for 98% or more of the included patients and all were independently associated with both presence of HAI and receiving an antimicrobial agent. The patient-based protocol required more work than the unit-based protocol, but allowed collecting detailed data and analysis of risk factors for HAI and antimicrobial use.

Validation of the G.LAB MD2200 wrist blood pressure monitor according to the European Society of Hypertension, the British Hypertension Society, and the International Organization for Standardization Protocols.

PubMed

Liu, Ze-Yu; Zhang, Qing-Han; Ye, Xiao-Lei; Liu, Da-Peng; Cheng, Kang; Zhang, Chun-Hai; Wan, Yi

2017-04-01

To validate the G.LAB MD2200 automated wrist blood pressure (BP) monitors according to the European Society of Hypertension International Protocol (ESH-IP) revision 2010, the British Hypertension Society (BHS), and the International Organization for Standardization (ISO) 81060-2:2013 protocols. The device was assessed on 33 participants according to the ESH requirements and was then tested on 85 participants according to the BHS and ISO 81060-2:2013 criteria. The validation procedures and data analysis followed the protocols precisely. The G.LAB MD2200 devices passed all parts of ESH-IP revision 2010 for both systolic and diastolic BP, with a device-observer difference of 2.15±5.51 and 1.51±5.16 mmHg, respectively. The device achieved A/A grading for the BHS protocol and it also fulfilled the criteria of ISO 81060-2:2013, with mean differences of systolic and diastolic BP between the device and the observer of 2.19±5.21 and 2.11±4.70 mmHg, respectively. The G.LAB MD2200 automated wrist BP monitor passed the ESH-IP revision 2010 and the ISO 81060-2:2013 protocol, and achieved the A/A grade of the BHS protocol, which can be recommended for self-measurement in the general population.

Challenges in standardization of blood pressure measurement at the population level.

PubMed

Tolonen, Hanna; Koponen, Päivikki; Naska, Androniki; Männistö, Satu; Broda, Grazyna; Palosaari, Tarja; Kuulasmaa, Kari

2015-04-10

Accurate blood pressure measurements are needed in clinical practice, intervention studies and health examination surveys. Blood pressure measurements are sensitive: their accuracy can be affected by measurement environment, behaviour of the subject, measurement procedures, devices used for the measurement and the observer. To minimize errors in blood pressure measurement, a standardized measurement protocol is needed. The European Health Examination Survey (EHES) Pilot project was conducted in 2009-2012. A pilot health examination survey was conducted in 12 countries using a standardized protocol. The measurement protocols used in each survey, training provided for the measurers, measurement data, and observations during site visits were collected and evaluated to assess the level of standardization. The EHES measurement protocol for blood pressure was followed accurately in all 12 pilot surveys. Most of the surveys succeeded in organizing a quiet and comfortable measurement environment, and staff instructed survey participants appropriately before examination visits. In all surveys, blood pressure was measured three times, from the right arm in a sitting posture. The biggest variation was in the device used for the blood pressure measurement. It is possible to reach a high level of standardization for blood pressure measurements across countries and over time. A detailed, standardized measurement protocol, and adequate training and monitoring during the fieldwork and centrally organized quality assessment of the data are needed. The recent EU regulation banning the sale of mercury sphygmomanometer in European Union Member States has set new challenges for the standardization of measurement devices since the validity of oscillometric measurements is device-specific and performance of aneroid devices depends very much on calibration.

Prevalence, distribution and identification of Phytophthora species from bleeding canker on European beech

USDA-ARS?s Scientific Manuscript database

While bleeding canker of European beech (Fagus sylvatica) has long been recognized as a problem, the cause in the northeastern United States has not been clear. To resolve this, we surveyed for disease prevalence, identified the pathogens involved, proved their pathogenicity, compared protocols for ...

Development of an open source package for the processing of sun-sky photometric data in the European Skyrad Users network (ESR)

NASA Astrophysics Data System (ADS)

Estelles, V.; Smyth, T.; Campanelli, M.; Utrillas, M. P.

2009-04-01

The European SkyRad users network (ESR) is a joint initiative from the Institute of Atmospheric and Climate Sciences (ISAC) at the National Research Council (CNR) in Italy, the Group of Solar Radiation (GRSV) at the University of Valencia (UV) in Spain, and the Plymouth Marine Laboratory (PML) in the United Kingdom. It was started as a Protocol of Agreement between the three institutions, in 2003. The main objective was to collaborate on the improvement of some technical aspects of the Skyrad.pack algorithm. Currently the network is addressed at European research groups that are users of sun - sky photometers and mainly focus their research on the study of atmospheric aerosols and their application to remote sensing or climatological studies. There exist well known international networks such as AERONET (Aerosol Robotic Network) or SKYNET (SKYrad NETwork, in Asia) but they have some characteristics that actually prevent many European research groups to get involved with them. These limitations mean that a number of European groups are working independently, with no coordination. The resultant databases are not made public or the employed methodology is not homogeneous. In turn, it means that a great amount of data is being lost for critical regional studies in Europe. One of these limitations is related to the supported instrumentation. International networks usually adopt a given model of sun photometer as a standard. The ESR is a multi instrumental network using both Prede POM and Cimel CE318 sun - sky photometers. Another limitation is related to the calibration. In the case of AERONET, a centralized and stringent calibration protocol is adopted. This protocol is designed in order to offer a well tracked and quality assured calibration and data elaboration; it is in fact the key stone for the homogeneity of the network results. But centralization raises other problems. The instruments must be periodically sent every 6 - 12 months to United States or France; therefore, 1) the instrument absence generates considerable data gaps, 2) it is also a chance for equipment damage during the transport, and 3) the proprietary group must cope with the economical cost of these international insured deliveries. Moreover, the protocol constrains the network capability to handle a large amount of instruments. In fact, AERONET is very reluctant at the moment to accept new sites in Europe. ESR has developed an improved version of the Langley plot technique (SKYIL) that allows the users to perform a continuous in situ calibration. Previous results show that the obtained uncertainties in the calibration factors (1.0 - 2.5%) are very similar to the uncertainty values for field instruments in AERONET (1.0 - 2.0%). A third difference that could make ESR more appealing to some European research groups is related to the algorithms itself. The core inversion code (Skyrad.pack), the calibration codes and all the automatization scripts are free open source codes that can be further customized by the users. Therefore, an advanced user could easily access and modify the algorithms for new improvements. As a conclusion, the ESR users network has been conceived as a flexible network and collaborative platform for European groups whose main research is focused on atmospheric aerosols characterization and model development. The package we have developed for the network is an open source product that is available for public use, both for Cimel CE318 and Prede POM instruments.

Magnetic-activated cell sorting before density gradient centrifugation improves recovery of high-quality spermatozoa.

PubMed

Berteli, T S; Da Broi, M G; Martins, W P; Ferriani, R A; Navarro, P A

2017-07-01

Recent studies have evaluated the use of magnetic-activated cell sorting (MACS) to reduce apoptotic spermatozoa and improve sperm quality. However, the efficiency of using MACS alone, before or after sperm processing by density gradient centrifugation (DGC) has not yet been established. The purpose of this study is to determine the optimal protocol of MACS in assisted reproduction techniques (ART). Thus, we compared sperm quality obtained by DGC alone (DGC), DGC followed by MACS (DGC-MACS), MACS followed by DGC (MACS-DGC), and MACS alone (MACS), and found that the combined methods (MACS-DGC and DGC-MACS) led to retrieval of less spermatozoa with fragmented DNA compared to the single protocols. However, MACS-DGC protocol led to a significantly higher percentage of spermatozoa with progressive motility and normal morphology than DGC-MACS protocol. These findings suggest the potential clinical value of using MACS-DGC to improve sperm quality in seminal preparation for ART. © 2017 American Society of Andrology and European Academy of Andrology.

Prevalence and trends of thinness, overweight and obesity among children and adolescents aged 3-18 years across Europe: a protocol for a systematic review and meta-analysis.

PubMed

Garrido-Miguel, Miriam; Cavero-Redondo, Iván; Álvarez-Bueno, Celia; Rodriguez-Artalejo, Fernando; Moreno Aznar, Luis; Ruiz, Jonatan R; Martinez-Vizcaino, Vicente

2017-12-21

Increasing prevalence of both thinness and excess weight during childhood and adolescence is a significant public health issue because of short-term health consequences and long-term tracking of weight status. Monitoring weight status in Europe may serve to identify countries and regions where rates of these disorders are either slowing down or increasing to evaluate recent policies aimed at appropriate body weight, and to direct future interventions. This study protocol provides a standardised and transparent methodology to improve estimating trends of thinness, overweight and obesity in children aged 3-18 years and adolescents across the European region between 2000 and 2017. This protocol is guided by the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) and the Cochrane Collaboration Handbook. To identify relevant studies, a search will be conducted in MEDLINE, EMBASE, Cochrane Library, CINAHL and Web of Science databases. From the selected studies, relevant references will be screened as supplemental sources. Finally, open search in websites from health institutions will be conducted to identify weight status data not published in scientific journals. Cross-sectional, follow-up studies and panel surveys reporting weight status (objectively measured height and weight) according to the International Obesity Task Force criteria, and written in English or Spanish will be included. Subgroup analyses will be carried out by gender, age, study year and country or European region. This study will provide a comprehensive description of weight status of children and adolescents across Europe from 2000 to 2017. The results will be disseminated in a peer-reviewed journal. This study will use data exclusively from published research or institutional literature, so institutional ethical approval is not required. CRD42017056917. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Prevalence and trends of thinness, overweight and obesity among children and adolescents aged 3–18 years across Europe: a protocol for a systematic review and meta-analysis

PubMed Central

Garrido-Miguel, Miriam; Cavero-Redondo, Iván; Álvarez-Bueno, Celia; Rodriguez-Artalejo, Fernando; Moreno Aznar, Luis; Ruiz, Jonatan R; Martinez-Vizcaino, Vicente

2017-01-01

Introduction Increasing prevalence of both thinness and excess weight during childhood and adolescence is a significant public health issue because of short-term health consequences and long-term tracking of weight status. Monitoring weight status in Europe may serve to identify countries and regions where rates of these disorders are either slowing down or increasing to evaluate recent policies aimed at appropriate body weight, and to direct future interventions. This study protocol provides a standardised and transparent methodology to improve estimating trends of thinness, overweight and obesity in children aged 3–18 years and adolescents across the European region between 2000 and 2017. Methods and analysis This protocol is guided by the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) and the Cochrane Collaboration Handbook. To identify relevant studies, a search will be conducted in MEDLINE, EMBASE, Cochrane Library, CINAHL and Web of Science databases. From the selected studies, relevant references will be screened as supplemental sources. Finally, open search in websites from health institutions will be conducted to identify weight status data not published in scientific journals. Cross-sectional, follow-up studies and panel surveys reporting weight status (objectively measured height and weight) according to the International Obesity Task Force criteria, and written in English or Spanish will be included. Subgroup analyses will be carried out by gender, age, study year and country or European region. Discussion This study will provide a comprehensive description of weight status of children and adolescents across Europe from 2000 to 2017. The results will be disseminated in a peer-reviewed journal. This study will use data exclusively from published research or institutional literature, so institutional ethical approval is not required. PROSPERO registration number CRD42017056917. PMID:29273660

2017 European guideline for the screening, prevention and initial management of hepatitis B and C infections in sexual health settings.

PubMed

Brook, Gary; Brockmeyer, Norbert; van de Laar, Thijs; Schellberg, Sven; Winter, Andrew J

2018-01-01

This guideline updates the 2010 European guideline for the management of hepatitis B and C virus infections. It is primarily intended to provide advice on testing, prevention and initial management of viral hepatitis B and C for clinicians working in sexual health clinical settings in European countries. The guideline is in a new question and answer format based on clinical situations, from which population/intervention/comparison/outcome questions were formulated. Updates cover areas such as epidemiology, point-of-care tests for hepatitis B, hepatitis C risk and 'chemsex', and HIV pre-exposure prophylaxis and hepatitis B. We have also included a short paragraph on hepatitis E noting there is no evidence for sexual transmission. The guideline has been prepared in accordance with the Europe protocol for production available at http://www.iusti.org/regions/europe/pdf/2017/ProtocolForProduction2017.pdf.

A case-crossover study of transient risk factors influence on occupational injuries: a study protocol based on a review of previous studies.

PubMed

Oesterlund, Anna H; Lander, Flemming; Lauritsen, Jens

2016-10-01

The occupational injury incident rate remains relatively high in the European Union. The case-crossover study gives a unique opportunity to study transient risk factors that normally would be very difficult to approach. Studies like this have been carried out in both America and Asia, but so far no relevant research has been conducted in Europe. Case-crossover studies of occupational injuries were collected from PubMed and Embase and read through. Previous experiences concerning method, exposure and outcome, time-related measurements and construction of the questionnaire were taken into account in the preparation of a pilot study. Consequently, experiences from the pilot study were used to design the study protocol. Approximately 2000 patients with an occupational injury will be recruited from the emergency departments in Herning and Odense, Denmark. A standardised questionnaire will be used to collect basic demographic data and information on eight transient risk factors. Based on previous studies and knowledge on occupational injuries the transient risk factors we chose to examine were: time pressure, performing a task with a different method/using unaccustomed technique, change in working surroundings, using a phone, disagreement, feeling ill, being distracted and using malfunctioning machinery/tools or work material. Exposure time 'just before the injury' will be compared with two control periods, 'previous day at the same time of the injury' (pair match) and the previous work week (usual frequency). This study protocol describes a unique opportunity to calculate the effect of transient risk factors on occupational injuries in a European setting. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Adaptability and reproducibility of a memory disruption rTMS protocol in the PharmaCog IMI European project.

PubMed

Martin-Trias, Pablo; Lanteaume, Laura; Solana, Elisabeth; Cassé-Perrot, Catherine; Fernández-Cabello, Sara; Babiloni, Claudio; Marzano, Nicola; Junqué, Carme; Rossini, Paolo Maria; Micallef, Joëlle; Truillet, Romain; Charles, Estelle; Jouve, Elisabeth; Bordet, Régis; Santamaria, Joan; Jovicich, Jorge; Rossi, Simone; Pascual-Leone, Alvaro; Blin, Olivier; Richardson, Jill; Bartrés-Faz, David

2018-06-19

Transcranial magnetic stimulation (TMS) can interfere with cognitive processes, such as transiently impairing memory. As part of a multi-center European project, we investigated the adaptability and reproducibility of a previously published TMS memory interfering protocol in two centers using EEG or fMRI scenarios. Participants were invited to attend three experimental sessions on different days, with sham repetitive TMS (rTMS) applied on day 1 and real rTMS on days 2 and 3. Sixty-eight healthy young men were included. On each experimental day, volunteers were instructed to remember visual pictures while receiving neuronavigated rTMS trains (20 Hz, 900 ms) during picture encoding at the left dorsolateral prefrontal cortex (L-DLPFC) and the vertex. Mixed ANOVA model analyses were performed. rTMS to the L-DLPFC significantly disrupted recognition memory on experimental day 2. No differences were found between centers or between fMRI and EEG recordings. Subjects with lower baseline memory performances were more susceptible to TMS disruption. No stability of TMS-induced memory interference could be demonstrated on day 3. Our data suggests that adapted cognitive rTMS protocols can be implemented in multi-center studies incorporating standardized experimental procedures. However, our center and modality effects analyses lacked sufficient statistical power, hence highlighting the need to conduct further studies with larger samples. In addition, inter and intra-subject variability in response to TMS might limit its application in crossover or longitudinal studies.

Validation of the AVITA BPM64 upper-arm blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010.

PubMed

Kang, Yuan-Yuan; Chen, Qi; Liu, Chang-Yuan; Li, Yan; Wang, Ji-Guang

2018-02-01

The aim of this study was to evaluate the accuracy of the automated oscillometric upper arm blood pressure (BP) monitor AVITA BPM64 for home BP monitoring according to the International Protocol of the European Society of Hypertension revision 2010. Systolic and diastolic BPs were measured sequentially in 33 adult Chinese (14 women, mean age 47.0 years) using a mercury sphygmomanometer (two observers) and the AVITA BPM64 device (one supervisor). A total of 99 pairs of comparisons were obtained from 33 participants for judgments in two parts with three grading phases. The AVITA BPM64 device achieved the targets in part 1 of the validation study. The number of absolute differences between device and observers within 5, 10, and 15 mmHg was 91/99, 98/99, and 98/99, respectively, for systolic BP and 92/99, 99/99, and 99/99, respectively, for diastolic BP. The device also fulfilled the criteria in part 2 of the validation study. Thirty-two participants for both systolic and diastolic BP had at least two of the three device-observer differences within 5 mmHg (required ≥24). Only one participant for systolic BP had all three device-observer comparisons greater than 5 mmHg. The AVITA upper arm BP monitor BPM64 has passed the requirements of the International Protocol revision 2010, and hence can be recommended for home use in adults.

Validation of the Beurer BM 44 upper arm blood pressure monitor for home measurement, according to the European Society of Hypertension International Protocol 2002.

PubMed

Lüders, Stephan; Krüger, Ralf; Zemmrich, Claudia; Forstner, Klaus; Sturm, Claus-Dieter; Bramlage, Peter

2012-12-01

The present study aimed to validate the automated upper arm blood pressure (BP) measuring device BM 44 for home BP monitoring according to the 2002 Protocol of the European Society of Hypertension. The most important new feature of the new device was an integrated 'WHO indicator', which categorizes the patient's individual result within the WHO recommendations for target BP by a coloured scale. Systolic and diastolic BPs were measured sequentially in 35 adult participants (16 men, 19 women) using a standard mercury y-tubed reference sphygmomanometer (two observers) and the BM 44 device (one supervisor). Ninety-nine pairs of comparisons were obtained from 15 participants in phase 1 and a further 18 participants in phase 2 of the validation study. The BM 44 device passed phase 1 of the validation study successfully with a number of absolute differences between device and observers of 5, 10 and 15 mmHg for at least 28 out of 25, 35 out of 35 and 40 out of 40 measurements, respectively. The device also achieved the targets for phases 2.1 and 2.2, with 23 and 26 participants having had at least two of three device-observers differences within 5 mmHg for systolic and diastolic BP, respectively. The Beurer BM 44 upper arm BP monitor has passed the International Protocol requirements, and hence can be recommended for home use in adults. © 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins.

Validation of the iHealth BP3 upper-arm blood pressure monitor, for clinic use and self-measurement, according to the European Society of Hypertension International Protocol revision 2010.

PubMed

Chen, Can; Shang, Fujun; Wang, Jiepin; Chen, Jianghong; Ji, Na; Wan, Yi

2012-12-01

This study aimed to evaluate the performance of the iHealth BP3 upper-arm blood pressure monitor, which is designed for clinic use and self-measurement of blood pressure using Apple touch devices as an interface. The European Society of Hypertension International Protocol (ESH-IP) revision 2010 for the validation of blood pressure measuring devices in adults was followed precisely. Ninty-nine couples of test device and reference blood pressure measurements were obtained during the study (three pairs for each of the 33 participants). The 33 participants, age 47.1±12.3 years (age range 27-69 years) and arm circumference 30.0±4.4 cm, had a mean systolic blood pressure (SBP) of 143.9±27.4 mmHg and a mean diastolic blood pressure (DBP) of 90.1±18.3 mmHg. The device passed all of the requirements fulfilling the standards of the protocol, and the mean±SD device-observer difference was 2.8±4.2 mmHg for SBP and -0.4±3.5 mmHg for DBP. According to the results of the validation study on the basis of the ESH-IP revision 2010, the iHealth BP3 can be recommended for clinic use and self-measurement in an adult population. © 2012 Wolters Kluwer Health | Lippincott Williams & Wilkins.

Policy recommendations and cost implications for a more sustainable framework for European human biomonitoring surveys.

PubMed

Joas, Anke; Knudsen, Lisbeth E; Kolossa-Gehring, Marike; Sepai, Ovnair; Casteleyn, Ludwine; Schoeters, Greet; Angerer, Jürgen; Castaño, Argelia; Aerts, Dominique; Biot, Pierre; Horvat, Milena; Bloemen, Louis; Reis, M Fátima; Lupsa, Ioana-Rodica; Katsonouri, Andromachi; Cerna, Milena; Berglund, Marika; Crettaz, Pierre; Rudnai, Peter; Halzlova, Katarina; Mulcahy, Maurice; Gutleb, Arno C; Fischer, Marc E; Becher, Georg; Fréry, Nadine; Jensen, Genon; Van Vliet, Lisette; Koch, Holger M; Den Hond, Elly; Fiddicke, Ulrike; Esteban, Marta; Exley, Karen; Schwedler, Gerda; Seiwert, Margarete; Ligocka, Danuta; Hohenblum, Philipp; Kyrtopoulos, Soterios; Botsivali, Maria; DeFelip, Elena; Guillou, Claude; Reniero, Fabiano; Grazuleviciene, Regina; Veidebaum, Toomas; Mørck, Thit A; Nielsen, Jeanette K S; Jensen, Janne F; Rivas, Teresa C; Sanchez, Jinny; Koppen, Gudrun; Smolders, Roel; Kozepesy, Szilvia; Hadjipanayis, Adamos; Krskova, Andrea; Mannion, Rory; Jakubowski, Marek; Fucic, J Aleksandra; Pereira-Miguel, Jose; Gurzau, Anca E; Jajcaj, Michal; Mazej, Darja; Tratnik, Janja Snoj; Lehmann, Andrea; Larsson, Kristin; Dumez, Birgit; Joas, Reinhard

2015-08-01

The potential of Human Biomonitoring (HBM) in exposure characterisation and risk assessment is well established in the scientific HBM community and regulatory arena by many publications. The European Environment and Health Strategy as well as the Environment and Health Action Plan 2004-2010 of the European Commission recognised the value of HBM and the relevance and importance of coordination of HBM programmes in Europe. Based on existing and planned HBM projects and programmes of work and capabilities in Europe the Seventh Framework Programme (FP 7) funded COPHES (COnsortium to Perform Human Biomonitoring on a European Scale) to advance and improve comparability of HBM data across Europe. The pilot study protocol was tested in 17 European countries in the DEMOCOPHES feasibility study (DEMOnstration of a study to COordinate and Perform Human biomonitoring on a European Scale) cofunded (50%) under the LIFE+ programme of the European Commission. The potential of HBM in supporting and evaluating policy making (including e.g. REACH) and in awareness raising on environmental health, should significantly advance the process towards a fully operational, continuous, sustainable and scientifically based EU HBM programme. From a number of stakeholder activities during the past 10 years and the national engagement, a framework for sustainable HBM structure in Europe is recommended involving national institutions within environment, health and food as well as European institutions such as ECHA, EEA, and EFSA. An economic frame with shared cost implications for national and European institutions is suggested benefitting from the capacity building set up by COPHES/DEMOCOPHES. Copyright © 2014 Elsevier Inc. All rights reserved.

Validation of Omron RS8, RS6, and RS3 home blood pressure monitoring devices, in accordance with the European Society of Hypertension International Protocol revision 2010.

PubMed

Takahashi, Hakuo; Yoshika, Masamichi; Yokoi, Toyohiko

2013-01-01

Allowing patients to measure their blood pressure at home is recognized as being of clinical value. However, it is not known how often these measurements are taken correctly. Blood pressure monitors for home use fall into two types based on the position of the cuff, ie, at the upper arm or the wrist. The latter is particularly convenient, as measurements can be taken fully clothed. This study aimed to evaluate the performance of the wrist-type blood pressure monitors Omron RS8 (HEM-6310F-E), Omron RS6 (HEM-6221-E), and Omron RS3 (HEM-6130-E). A team of three trained doctors validated the performance of these devices by comparing the measurements obtained from these devices with those taken using a standard mercury sphygmomanometer. All the devices met the validation requirements of the European Society of Hypertension International Protocol revision 2010. The difference in blood pressure readings between the tested device and the standard mercury sphygmomanometer was within 3 mmHg, which is acceptable according to the European Society of Hypertension guidelines. All the home devices tested were found to be suitable for measuring blood pressure at home because their performance fulfilled the requirement of the guidelines.

The EMBARC European Bronchiectasis Registry: protocol for an international observational study

PubMed Central

Aliberti, Stefano; Polverino, Eva; Vendrell, Montserrat; Crichton, Megan; Loebinger, Michael; Dimakou, Katerina; Clifton, Ian; van der Eerden, Menno; Rohde, Gernot; Murris-Espin, Marlene; Masefield, Sarah; Gerada, Eleanor; Shteinberg, Michal; Ringshausen, Felix; Haworth, Charles; Boersma, Wim; Rademacher, Jessica; Hill, Adam T.; Aksamit, Timothy; O'Donnell, Anne; Morgan, Lucy; Milenkovic, Branislava; Tramma, Leandro; Neves, Joao; Menendez, Rosario; Paggiaro, Perluigi; Botnaru, Victor; Skrgat, Sabina; Wilson, Robert; Goeminne, Pieter; De Soyza, Anthony; Welte, Tobias; Torres, Antoni; Elborn, J. Stuart; Blasi, Francesco

2016-01-01

Bronchiectasis is one of the most neglected diseases in respiratory medicine. There are no approved therapies and few large-scale, representative epidemiological studies. The EMBARC (European Multicentre Bronchiectasis Audit and Research Collaboration) registry is a prospective, pan-European observational study of patients with bronchiectasis. The inclusion criterion is a primary clinical diagnosis of bronchiectasis consisting of: 1) a clinical history consistent with bronchiectasis; and 2) computed tomography demonstrating bronchiectasis. Core exclusion criteria are: 1) bronchiectasis due to known cystic fibrosis; 2) age <18 years; and 3) patients who are unable or unwilling to provide informed consent. The study aims to enrol 1000 patients by April 2016 across at least 20 European countries, and 10 000 patients by March 2020. Patients will undergo a comprehensive baseline assessment and will be followed up annually for up to 5 years with the goal of providing high-quality longitudinal data on outcomes, treatment patterns and quality of life. Data from the registry will be available in the form of annual reports. and will be disseminated in conference presentations and peer-reviewed publications. The European Bronchiectasis Registry aims to make a major contribution to understanding the natural history of the disease, as well as guiding evidence-based decision making and facilitating large randomised controlled trials. PMID:27730179

A pilot methodology study for the photographic assessment of post-inflammatory hyperpigmentation in patients treated with tretinoin.

PubMed

Rossi, A B; Leyden, J J; Pappert, A S; Ramaswamy, A; Nkengne, A; Ramaswamy, R; Nighland, M

2011-04-01

Post-inflammatory hyperpigmentation (PIH) is a common occurrence in patients with acne vulgaris, particularly in those with skin of colour. A previous study has demonstrated the benefit of tretinoin (retinoic acid) in the treatment of PIH; however, there is currently no standard protocol to evaluate change in PIH following treatment. Based on these findings, we performed a pilot, exploratory, blinded, intraindividual-controlled methodology study that consisted of a photographic assessment protocol with facial mapping.   The study was based on a secondary analysis of a phase 4, community-based trial of 544 acne patients who were treated with tretinoin gel microsphere 0.04% or 0.1%. Only patients with Fitzpatrick types III-V (skin of colour) were included in the study; subjects with Fitzpatrick skin type VI were excluded because the photographic assessment did not allow for proper evaluation. Despite the small number of subjects evaluated (n=25), the results revealed consistent assessment of improvement in PIH between two independent graders (weighted κ=0.84). Further study with a larger population is recommended to validate the accuracy of this method. © 2010 Johnson & Johnson Consumer Companies, Inc. Journal of the European Academy of Dermatology and Venereology © 2010 European Academy of Dermatology and Venereology.

Impact of applying the more stringent validation criteria of the revised European Society of Hypertension International Protocol 2010 on earlier validation studies.

PubMed

Stergiou, George S; Karpettas, Nikos; Atkins, Neil; O'Brien, Eoin

2011-04-01

Since 2002 when the European Society of Hypertension International Protocol (ESH-IP) was published it has become the preferred protocol for validating blood pressure monitors worldwide. In 2010, a revised version of the ESH-IP with more stringent criteria was published. This study assesses the impact of applying the revised ESH-IP criteria. A systematic literature review of ESH-IP studies reported between 2002 and 2010 was conducted. The impact of applying the ESH-IP 2010 criteria retrospectively on the data reported in these studies was investigated. The performance of the oscillometric devices in the last decade was also investigated on the basis of the ESH-IP criteria. Among 119 published studies, 112 with sufficient data were analyzed. According to ESH-IP 2002, the test device failed in 19 studies, whereas by applying the ESH-IP 2010 criteria in 28 additional studies increased the failure rate from 17 to 42%. Of these 28 studies, in 20 (71%) the test device failed at part 1 (accuracy per measurement) and in 22 (79%) at part 2 (accuracy per subject). Most of the failures involved the '5 mmHg or less' criterion. In the last decade there has been a consistent trend toward improved performance of oscillometric devices assessed on the basis of the ESH-IP criteria. This retrospective analysis shows that the stricter revised ESH-IP 2010 criteria will noticeably increase the failure rate of devices being validated. Oscillometric devices are becoming more accurate, and the revised ESH-IP by acknowledging this trend will allow more accurate devices to enter the market.

Family Carers' Experiences Using Support Services in Europe: Empirical Evidence from the EUROFAMCARE Study

ERIC Educational Resources Information Center

Lamura, Giovanni; Mnich, Eva; Nolan, Mike; Wojszel, Beata; Krevers, Barbro; Mestheneos, Liz; Dohner, Hanneli

2008-01-01

Purpose: This article explores the experiences of family carers of older people in using support services in six European countries: Germany, Greece, Italy, Poland, Sweden, and the UK. Design and Methods: Following a common protocol, data were collected from national samples of approximately 1,000 family carers per country and clustered into…

Validation of the Somnotouch-NIBP noninvasive continuous blood pressure monitor according to the European Society of Hypertension International Protocol revision 2010.

PubMed

Bilo, Grzegorz; Zorzi, Cristina; Ochoa Munera, Juan E; Torlasco, Camilla; Giuli, Valentina; Parati, Gianfranco

2015-10-01

The present study aimed to evaluate the accuracy of the Somnotouch-NIBP noninvasive continuous blood pressure monitor according to the European Society of Hypertension International Protocol revision 2010. Systolic and diastolic blood pressures were sequentially measured in 33 adults (11 women, mean age 63.5±11.9 years) using a mercury sphygmomanometer (two observers) and the Somnotouch-NIBP device (one supervisor). A total of 99 pairs of comparisons were obtained from 33 participants for judgments in two parts with three grading phases. All the validation requirements were fulfilled. The Somnotouch-NIBP device fulfilled the requirements of the part 1 of the validation study. The number of absolute differences between device and observers within 5, 10, and 15 mmHg was 75/99, 90/99, and 96/99, respectively, for systolic blood pressure and 90/99, 99/99, and 99/99, respectively, for diastolic blood pressure. The device also fulfilled the criteria in part 2 of the validation study. Twenty-seven and 31 participants had at least two of the three device-observers differences less than or equal to 5 mmHg for systolic and diastolic blood pressure, respectively. All three device-observer differences were greater than 5 mmHg in two participants for systolic and in one participant for diastolic blood pressure. The Somnotouch-NIBP noninvasive continuous blood pressure monitor has passed the requirements of the International Protocol revision 2010, and hence can be recommended for blood pressure monitoring in adults, at least under conditions corresponding to those investigated in our study.

Validation of four devices: Omron M6 Comfort, Omron HEM-7420, Withings BP-800, and Polygreen KP-7670 for home blood pressure measurement according to the European Society of Hypertension International Protocol.

PubMed

Topouchian, Jirar; Agnoletti, Davide; Blacher, Jacques; Youssef, Ahmed; Chahine, Mirna N; Ibanez, Isabel; Assemani, Nathalie; Asmar, Roland

2014-01-01

Four oscillometric devices, including the Omron M6 Comfort, Omron HEM-7420, Withings BP-800, and Polygreen KP-7670, designed for self-blood pressure measurement (SBPM) were evaluated according to the European Society of Hypertension (ESH) International Protocol Revision 2010 in four separate studies. The four devices measure brachial blood pressure (BP) using the oscillometric method. The Withings BP-800 has to be connected to an Apple® iOS device such as an iPhone®, iPad®, or iPod®. The ESH International Protocol Revision 2010 includes a total number of 33 subjects. The difference between observer and device BP values was calculated for each measure. Ninety-nine pairs of BP differences were classified into three categories (≤5 mmHg, ≤10 mmHg, ≤15 mmHg). The protocol procedures were followed precisely in each of the four studies. All four tested devices passed the validation process. The mean differences between the device and mercury readings were: -1.8±5.1 mmHg and -0.4±2.8 mmHg for systolic and diastolic BP, respectively, using the Omron M6 Comfort device; 2.5±4.6 mmHg and -1.2±4.3 mmHg for the Omron HEM-7420 device; -0.2±5.0 mmHg and 0.4±4.2 mmHg for the Withings BP-800 device; and 3.0±5.3 mmHg and 0.3±5.2 mmHg for the Polygreen KP-7670 device. Omron M6 Comfort, Omron HEM-7420, Withings BP-800, and Polygreen KP-7670 readings differing by less than 5 mmHg, 10 mmHg, and 15 mmHg fulfill the ESH International Protocol Revision 2010 requirements, and therefore are suitable for use by patients for SBPM, if used correctly.

Effect of genetic ancestry to the risk of susceptibility to gastric cancer in a mixed population of the Brazilian Amazon.

PubMed

da Silva, Ellen Moreno; Fernandes, Marianne Rodrigues; de Carvalho, Darlen Cardoso; Leitao, Luciana Pereira Colares; Cavalcante, Giovanna Chaves; Pereira, Esdras Edgar Batista; Modesto, Antônio André Conde; Guerreiro, João Farias; de Assumpção, Paulo Pimentel; Dos Santos, Sidney Emanuel Batista; Dos Santos, Ney Pereira Carneiro

2017-11-29

Global literature describes differences in the incidence of gastric cancer among populations. For instance, Europeans have lower incidence rates of gastric cancer in relation to Latin and Asian populations, particularly Korean and Japanese populations. However, only a few studies have been able to verify the occurrence of gastric cancer in admixed populations with high interethnic degree mix, such as the Brazilian Amazon region. We observed an increase in European ancestry in the control group compared to the case group (47% vs. 41%). Using increments of 10%, compared to categorical distribution of European ancestry in the sample, we found a difference in the contribution between cases and controls (p = 0.03). Multiple logistic regression was performed to determine the influence of European ancestry in susceptibility to gastric cancer in the sample. According to the adopted model, for each 10% increase in European ancestry, there is a 20% decrease chance of developing gastric cancer (P = 0.0121; OR = 0.81; 95% CI 0.54-0.83). Overall, the results suggest that a greater contribution of European ancestry can be a protective factor for the development of gastric cancer in the studied Amazon population. It can help to establish protocols able to predict susceptibility to gastric cancer in admixed populations.

Using the intervention mapping protocol to reduce European preschoolers' sedentary behavior, an application to the ToyBox-Study.

PubMed

De Decker, Ellen; De Craemer, Marieke; De Bourdeaudhuij, Ilse; Verbestel, Vera; Duvinage, Kristin; Iotova, Violeta; Grammatikaki, Evangelia; Wildgruber, Andreas; Mouratidou, Theodora; Manios, Yannis; Cardon, Greet

2014-02-19

High levels of sedentary behavior are often measured in preschoolers, but only a few interventions have been developed to counteract this. Furthermore, detailed descriptions of interventions in preschoolers targeting different forms of sedentary behavior could not be located in the literature. The aim of the present paper was to describe the different steps of the Intervention Mapping Protocol used towards the development of an intervention component of the ToyBox-study focusing on decreasing preschoolers' sedentary behavior. The ToyBox-study focuses on the prevention of overweight in 4- to 6-year-old children by implementing a multi-component kindergarten-based intervention with family involvement in six different European countries. Applying the Intervention Mapping Protocol, six different steps were systematically completed for the structured planning and development of the intervention. A literature search and results from focus groups with parents/caregivers and kindergarten teachers were used as a guide during the development of the intervention and the intervention materials. The application of the different steps in the Intervention Mapping Protocol resulted in the creation of matrices of change objectives, followed by the selection of practical applications for five different intervention tools that could be used at the individual level of the preschool child, at the interpersonal level (i.e., parents/caregivers) and at the organizational level (i.e., kindergarten teachers). No cultural differences regarding preschoolers' sedentary behavior were identified between the participating countries during the focus groups, so cultural and local adaptations of the intervention materials were not necessary to improve the adoption and implementation of the intervention. A systematic and evidence-based approach was used for the development of this kindergarten-based family-involved intervention targeting preschoolers, with the inclusion of parental involvement. The application of the Intervention Mapping Protocol may lead to the development of more effective interventions. The detailed intervention matrices that were developed as part of the ToyBox-study can be used by other researchers as an aid in order to avoid repetitive work for the design of similar interventions.

Using the intervention mapping protocol to reduce European preschoolers’ sedentary behavior, an application to the ToyBox-Study

PubMed Central

2014-01-01

Background High levels of sedentary behavior are often measured in preschoolers, but only a few interventions have been developed to counteract this. Furthermore, detailed descriptions of interventions in preschoolers targeting different forms of sedentary behavior could not be located in the literature. The aim of the present paper was to describe the different steps of the Intervention Mapping Protocol used towards the development of an intervention component of the ToyBox-study focusing on decreasing preschoolers’ sedentary behavior. The ToyBox-study focuses on the prevention of overweight in 4- to 6-year-old children by implementing a multi-component kindergarten-based intervention with family involvement in six different European countries. Methods Applying the Intervention Mapping Protocol, six different steps were systematically completed for the structured planning and development of the intervention. A literature search and results from focus groups with parents/caregivers and kindergarten teachers were used as a guide during the development of the intervention and the intervention materials. Results The application of the different steps in the Intervention Mapping Protocol resulted in the creation of matrices of change objectives, followed by the selection of practical applications for five different intervention tools that could be used at the individual level of the preschool child, at the interpersonal level (i.e., parents/caregivers) and at the organizational level (i.e., kindergarten teachers). No cultural differences regarding preschoolers’ sedentary behavior were identified between the participating countries during the focus groups, so cultural and local adaptations of the intervention materials were not necessary to improve the adoption and implementation of the intervention. Conclusions A systematic and evidence-based approach was used for the development of this kindergarten-based family-involved intervention targeting preschoolers, with the inclusion of parental involvement. The application of the Intervention Mapping Protocol may lead to the development of more effective interventions. The detailed intervention matrices that were developed as part of the ToyBox-study can be used by other researchers as an aid in order to avoid repetitive work for the design of similar interventions. PMID:24552138

European cardiovascular nurses' experiences of and attitudes towards having family members present in the resuscitation room.

PubMed

Axelsson, Asa B; Fridlund, Bengt; Moons, Philip; Mårtensson, Jan; Op Reimer, Wilma Scholte; Smith, Karen; Strömberg, Anna; Thompson, David R; Norekvål, Tone M

2010-03-01

To investigate cardiovascular nurses' experiences of and attitudes towards the presence of family members during resuscitation of adult patients. A 36-item questionnaire exploring the experiences of and attitudes towards family members being present in the resuscitation room was distributed to a convenience sample of nurses attending three national and one international cardiovascular nursing conferences held in Europe during 2007. Of 820 questionnaires distributed, 411(50%) completed ones were returned. Of these 411 respondents, 178 (44%) had experienced at least one situation of families being present. Positive (23%) and negative (21%) experiences of family presence were equally distributed. Only 28 (7%) respondents stated that their unit had a protocol covering family presence. Nurses in Ireland (n=30; 59%) and the UK (n=18; 55%) were most likely to have experienced family presence and protocols relating to this were most commonly found in the UK (n=4; 14%). Less than half of the included European cardiovascular nurses had experienced a situation of families being present during resuscitation and protocols pertaining to this were rare. There was no clear attitude towards family presence, though experience in nursing made nurses more favourable towards it. Copyright (c) 2009 European Society of Cardiology. Published by Elsevier B.V. All rights reserved.

Validation of the Omron HEM-7201 upper arm blood pressure monitor, for self-measurement in a high-altitude environment, according to the European Society of Hypertension International Protocol revision 2010.

PubMed

Cho, K; Tian, M; Lan, Y; Zhao, X; Yan, L L

2013-08-01

Few studies have been conducted on blood pressure monitors and their use at high altitude. This study is the first to evaluate the accuracy of an automatic blood pressure monitor in a high-altitude environment following a standard validation protocol. The Omron HEM-7201 upper arm blood pressure monitor was tested for accuracy in Lhasa, Tibet, China (3650 m above sea level) according to the European Society of Hypertension International Protocol revision 2010 (ESH-IP2). Thirty-three participants received 9-10 sequential blood pressure measurements alternating between a mercury sphygmomanometer and the device. The mean device-observer measurement difference was 1.0±5.9 mm Hg for systolic blood pressure (SBP) and -3.1±4.6 mm Hg for diastolic blood pressure (DBP). Of the 99 measurement pairs analyzed, 72, 90 and 97 device readings were within 5, 10 and 15 mm Hg, respectively, of the observer measurements for SBP, and 68, 92 and 99 readings for DBP. The number of participants with at least two out of three measurements within 5 mm Hg was 27 for SBP and 25 for DBP. Three participants had no measurements within 5 mm Hg for either SBP or DBP. As a result, the Omron HEM-7201 passes the ESH-IP2 validation criteria and can therefore be recommended for use in adults in this setting.

Short term effects of air pollution on health: a European approach using epidemiologic time series data: the APHEA protocol.

PubMed Central

Katsouyanni, K; Schwartz, J; Spix, C; Touloumi, G; Zmirou, D; Zanobetti, A; Wojtyniak, B; Vonk, J M; Tobias, A; Pönkä, A; Medina, S; Bachárová, L; Anderson, H R

1996-01-01

BACKGROUND AND OBJECTIVES: Results from several studies over the past five years have shown that the current levels of pollutants in Europe and North America have adverse short term effects on health. The APHEA project aims to quantifying these in Europe, using standardised methodology. The project protocol and analytical methodology are presented here. DESIGN: Daily time series data were gathered for several air pollutants (sulphur dioxide; particulate matter, measured as total particles or as the particle fraction with an aerodynamic diameter smaller than a certain cut off, or as black smoke; nitrogen dioxide; and ozone) and health outcomes (the total and cause specific number of deaths and emergency hospital admissions). The data included fulfilled the quality criteria set by the APHEA protocol. SETTING: Fifteen European cities from 10 different countries with a total population over 25 million. METHODOLOGY: The APHEA collaborative group decided on a specific methodological procedure to control for confounding effects and evaluate the hypothesis. At the same time there was sufficient flexibility to allow local characteristics to be taken into account. The procedure included modelling of all potential confounding factors (that is, seasonal and long term patterns, meteorological factors, day of the week, holidays, and other unusual events), choosing the "best" air pollution models, and applying diagnostic tools to check the adequacy of the models. The final analysis used autoregressive Poisson models allowing for overdispersion. Effects were reported as relative risks contrasting defined increases in the corresponding pollutant levels. Each participating group applied the analyses to their own data. CONCLUSIONS: This methodology enabled results from many different European settings to be considered collectively. It represented the best available compromise between feasibility, comparability, and local adaptibility when using aggregated time series data not originally collected for the purpose of epidemiological studies. PMID:8758218

Concerted Uranium Research in Europe (CURE): toward a collaborative project integrating dosimetry, epidemiology and radiobiology to study the effects of occupational uranium exposure.

PubMed

Laurent, Olivier; Gomolka, Maria; Haylock, Richard; Blanchardon, Eric; Giussani, Augusto; Atkinson, Will; Baatout, Sarah; Bingham, Derek; Cardis, Elisabeth; Hall, Janet; Tomasek, Ladislav; Ancelet, Sophie; Badie, Christophe; Bethel, Gary; Bertho, Jean-Marc; Bouet, Ségolène; Bull, Richard; Challeton-de Vathaire, Cécile; Cockerill, Rupert; Davesne, Estelle; Ebrahimian, Teni; Engels, Hilde; Gillies, Michael; Grellier, James; Grison, Stephane; Gueguen, Yann; Hornhardt, Sabine; Ibanez, Chrystelle; Kabacik, Sylwia; Kotik, Lukas; Kreuzer, Michaela; Lebacq, Anne Laure; Marsh, James; Nosske, Dietmar; O'Hagan, Jackie; Pernot, Eileen; Puncher, Matthew; Rage, Estelle; Riddell, Tony; Roy, Laurence; Samson, Eric; Souidi, Maamar; Turner, Michelle C; Zhivin, Sergey; Laurier, Dominique

2016-06-01

The potential health impacts of chronic exposures to uranium, as they occur in occupational settings, are not well characterized. Most epidemiological studies have been limited by small sample sizes, and a lack of harmonization of methods used to quantify radiation doses resulting from uranium exposure. Experimental studies have shown that uranium has biological effects, but their implications for human health are not clear. New studies that would combine the strengths of large, well-designed epidemiological datasets with those of state-of-the-art biological methods would help improve the characterization of the biological and health effects of occupational uranium exposure. The aim of the European Commission concerted action CURE (Concerted Uranium Research in Europe) was to develop protocols for such a future collaborative research project, in which dosimetry, epidemiology and biology would be integrated to better characterize the effects of occupational uranium exposure. These protocols were developed from existing European cohorts of workers exposed to uranium together with expertise in epidemiology, biology and dosimetry of CURE partner institutions. The preparatory work of CURE should allow a large scale collaborative project to be launched, in order to better characterize the effects of uranium exposure and more generally of alpha particles and low doses of ionizing radiation.

Incidence of C4d stain in protocol biopsies from renal allografts: results from a multicenter trial.

PubMed

Mengel, Michael; Bogers, Johannes; Bosmans, Jean-Louis; Serón, Daniel; Moreso, Francesc; Carrera, Marta; Gwinner, Wilfried; Schwarz, Anke; De Broe, Marc; Kreipe, Hans; Haller, Hermann

2005-05-01

C4d staining of renal allografts is regarded as an in situ marker of active humoral rejection. Few data are available about the incidence of C4d deposition in protocol biopsies compared to indication biopsies. To evaluate whether center-specific factors influence the incidence of C4d detection, we performed a multicenter study. From three European centers, 551 protocol and 377 indication biopsies were reclassified according to the updated Banff criteria and stained for C4d. C4d results were recorded as diffuse or focal positive and statistically correlated to clinical parameters, morphology and graft survival. In the protocol biopsies, a diffuse C4d stain was found in 2.0%, and a focal stain in 2.4%. In indication biopsies, 12.2% were diffusely and 8.5% focally C4d positive (protocol:indication p < 0.0001). The incidence of C4d deposition varied significantly between centers, attributable to variable numbers of presensitized patients with more C4d positive indication and protocol biopsies. Diffuse and focal C4d stain correlated with morphology of humoral rejection in protocol as well as in indication biopsies. Protocol biopsies show a significantly lower incidence of C4d deposition than indication biopsies. Subclinical C4d detection in protocol biopsies had no significant impact on allograft survival in our series.

A universal standard for the validation of blood pressure measuring devices: Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Collaboration Statement.

PubMed

Stergiou, George S; Alpert, Bruce; Mieke, Stephan; Asmar, Roland; Atkins, Neil; Eckert, Siegfried; Frick, Gerhard; Friedman, Bruce; Graßl, Thomas; Ichikawa, Tsutomu; Ioannidis, John P; Lacy, Peter; McManus, Richard; Murray, Alan; Myers, Martin; Palatini, Paolo; Parati, Gianfranco; Quinn, David; Sarkis, Josh; Shennan, Andrew; Usuda, Takashi; Wang, Jiguang; Wu, Colin O; O'Brien, Eoin

2018-03-01

: In the last 30 years, several organizations, such as the US Association for the Advancement of Medical Instrumentation (AAMI), the British Hypertension Society, the European Society of Hypertension (ESH) Working Group on Blood Pressure (BP) Monitoring and the International Organization for Standardization (ISO) have developed protocols for clinical validation of BP measuring devices. However, it is recognized that science, as well as patients, consumers and manufacturers would be best served if all BP measuring devices were assessed for accuracy according to an agreed single validation protocol that had global acceptance. Therefore, an international initiative was taken by AAMI, ESH and ISO experts who agreed to develop a universal standard for device validation. This statement presents the key aspects of a validation procedure, which were agreed by the AAMI, ESH and ISO representatives as the basis for a single universal validation protocol. As soon as the AAMI/ESH/ISO standard is fully developed, this will be regarded as the single universal standard and will replace all other previous standards/protocols.

A Universal Standard for the Validation of Blood Pressure Measuring Devices: Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Collaboration Statement.

PubMed

Stergiou, George S; Alpert, Bruce; Mieke, Stephan; Asmar, Roland; Atkins, Neil; Eckert, Siegfried; Frick, Gerhard; Friedman, Bruce; Graßl, Thomas; Ichikawa, Tsutomu; Ioannidis, John P; Lacy, Peter; McManus, Richard; Murray, Alan; Myers, Martin; Palatini, Paolo; Parati, Gianfranco; Quinn, David; Sarkis, Josh; Shennan, Andrew; Usuda, Takashi; Wang, Jiguang; Wu, Colin O; O'Brien, Eoin

2018-03-01

In the past 30 years, several organizations, such as the US Association for the Advancement of Medical Instrumentation (AAMI), the British Hypertension Society, the European Society of Hypertension (ESH) Working Group on Blood Pressure (BP) Monitoring, and the International Organization for Standardization (ISO), have developed protocols for clinical validation of BP measuring devices. However, it is recognized that science, as well as patients, consumers, and manufacturers, would be best served if all BP measuring devices were assessed for accuracy according to an agreed single validation protocol that had global acceptance. Therefore, an international initiative was taken by the AAMI, ESH, and ISO experts who agreed to develop a universal standard for device validation. This statement presents the key aspects of a validation procedure, which were agreed by the AAMI, ESH, and ISO representatives as the basis for a single universal validation protocol. As soon as the AAMI/ESH/ISO standard is fully developed, this will be regarded as the single universal standard and will replace all other previous standards/protocols. © 2018 American Heart Association, Inc., and Wolters Kluwer Health, Inc.

Validation of the Kingyield BP210 wrist blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension-International Protocol.

PubMed

Zeng, Wei-Fang; Huang, Qi-Fang; Sheng, Chang-Sheng; Li, Yan; Wang, Ji-Guang

2012-02-01

The present study aimed to evaluate the accuracy of the automated oscillometric wrist blood pressure monitor BP210 for home blood pressure monitoring according to the International Protocol of the European Society of Hypertension. Systolic and diastolic blood pressures were sequentially measured in 33 adult Chinese participants (21 women, 51 years of mean age) using a mercury sphygmomanometer (two observers) and the BP210 device (one supervisor). Ninety-nine pairs of comparisons were obtained from 15 participants in phase 1 and a further 18 participants in phase 2 of the validation study. Data analysis was conducted using the ESHIP analyzer. The BP210 device successfully passed phase 1 of the validation study with a number of absolute differences between device and observers within 5, 10, and 15 mmHg for at least 33/45, 44/45, and 44/45 measurements, respectively. The device also achieved the targets for phase 2.1, with 77/99, 95/99, and 97/99 differences within 5, 10, and 15 mmHg, respectively for systolic blood pressure, and with 78/99, 97/99, and 99/99 within 5, 10, and 15 mmHg, respectively for diastolic blood pressure. In phase 2.2, 29 and 25 participants had at least two of the three device-observers differences within 5 mmHg (required≥22) for systolic blood pressure and diastolic blood pressure, respectively. The Kingyield wrist blood pressure monitor BP210 has passed the International Protocol requirements, and hence can be recommended for home use in adults.

Validation of the Rossmax CF175 upper-arm blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010.

PubMed

Zhang, Lu; Kang, Yuan-Yuan; Zeng, Wei-Fang; Li, Yan; Wang, Ji-Guang

2015-04-01

The present study aimed to evaluate the accuracy of the Rossmax CF175 upper-arm blood pressure monitor for home blood pressure monitoring according to the International Protocol of the European Society of Hypertension revision 2010. Systolic and diastolic blood pressures were sequentially measured in 33 adult Chinese (17 women, mean age 46 years) using a mercury sphygmomanometer (two observers) and the Rossmax CF175 device (one supervisor). A total of 99 pairs of comparisons were obtained from 33 participants for judgments in two parts with three grading phases. All the blood pressure requirements were fulfilled. The Rossmax CF175 device achieved the targets in part 1 of the validation study. The number of absolute differences between the device and observers within 5, 10, and 15 mmHg was 78/99, 94/99, and 98/99, respectively, for systolic blood pressure, and 81/99, 96/99, and 97/99, respectively, for diastolic blood pressure. The device also achieved the criteria in part 2 of the validation study. Twenty-nine participants, for both of systolic and diastolic blood pressure, had at least two of the three device-observers differences within 5 mmHg (required ≥24). Only one participant for diastolic blood pressure had all three device-observers comparisons greater than 5 mmHg. The Rossmax automated oscillometric upper-arm blood pressure monitor CF175 fulfilled the requirements of the International Protocol revision 2010, and hence can be recommended for blood pressure measurement in adults.

Validation of the AVITA BPM15S wrist blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010.

PubMed

Kang, Yuan-Yuan; Zeng, Wei-Fang; Zhang, Lu; Li, Yan; Wang, Ji-Guang

2014-06-01

The present study aimed to evaluate the accuracy of the automated oscillometric wrist blood pressure monitor AVITA BPM15S for home blood pressure monitoring according to the International Protocol revision 2010 of the European Society of Hypertension. Systolic and diastolic blood pressures were sequentially measured in 33 Chinese adults (15 women, mean age 51 years) using a mercury sphygmomanometer (two observers) and the AVITA BPM15S device (one supervisor). Ninety-nine pairs of comparisons were obtained from 33 participants for judgments in two parts with three grading phases. The AVITA BPM15S device achieved the targets in part 1 of the validation study. The number of absolute differences between the device and observers within 5, 10, and 15 mmHg were 85/99, 94/99, and 98/99, respectively, for systolic blood pressure, and 82/99, 96/99, and 98/99, respectively, for diastolic blood pressure. The device also achieved the criteria in part 2 of the validation study. Thirty-two and 28 participants for systolic and diastolic blood pressure, respectively, had at least two of the three device-observer differences within 5 mmHg (required ≥ 24). No participant had all of the three device-observer comparisons greater than 5 mmHg for systolic or diastolic blood pressure. The AVITA wrist blood pressure monitor BPM15S fulfilled the requirements of the International Protocol revision 2010 and hence can be recommended for home use in an adult population.

Validation of the SCIAN LD-735 wrist blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010.

PubMed

Kang, Yuan-Yuan; Chen, Qi; Li, Yan; Wang, Ji-Guang

2016-08-01

This study aimed to evaluate the accuracy of the automated oscillometric wrist blood pressure monitor SCIAN LD-735 for home blood pressure monitoring according to the International Protocol of the European Society of Hypertension revision 2010. Systolic and diastolic blood pressures were measured sequentially in 33 adult Chinese participants (10 women, mean age 44.8 years) using a mercury sphygmomanometer (two observers) and the SCIAN LD-735 device (one supervisor). A total of 99 pairs of comparisons were obtained from 33 participants for judgments in two parts with three grading phases. The SCIAN LD-735 device achieved the targets in part 1 of the validation study. The number of absolute differences between device and observers within 5, 10, and 15 mmHg was 86/99, 97/99, and 98/99, respectively, for systolic blood pressure and 85/99, 98/99, and 99/99, respectively, for diastolic blood pressure. The device also fulfilled the criteria in part 2 of the validation study. In total, 30 and 33 participants for systolic and diastolic blood pressure, respectively, had at least two of the three device-observer differences within 5 mmHg (required ≥24). No participant had all of the three device-observer comparisons greater than 5 mmHg for systolic or diastolic blood pressure. The SCIAN wrist blood pressure monitor LD-735 has passed the requirements of the International Protocol revision 2010, and hence can be recommended for home use in adults.

Validation of the AVITA BPM17 wrist blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010.

PubMed

Kang, Yuan-Yuan; Chen, Qi; Liu, Chang-Yuan; Li, Yan; Wang, Ji-Guang

2017-08-01

The aim of the present study was to evaluate the accuracy of the automated oscillometric wrist blood pressure monitor AVITA BPM17 for home blood pressure monitoring according to the International Protocol of the European Society of Hypertension revision 2010. Systolic and diastolic blood pressures were sequentially measured in 33 adult Chinese (19 men, 45.7 years of mean age) using a mercury sphygmomanometer (two observers) and the AVITA BPM17 device (one supervisor). Ninety-nine pairs of comparisons were obtained from 33 participants for judgments in two parts with three grading phases. The AVITA BPM17 device achieved the targets in part 1 of the validation study. The number of absolute differences between device and observers within 5, 10, and 15 mmHg was 94/99, 98/99, and 98/99, respectively, for systolic blood pressure and 92/99, 99/99, and 99/99, respectively, for diastolic blood pressure. The device also fulfilled the criteria in part 2 of the validation study. Overall, 32 participants for both systolic and diastolic blood pressure, respectively, had at least two of the three device-observerss differences within 5 mmHg (required ≥24). None had all the three device-observers comparisons greater than 5 mmHg for systolic and diastolic blood pressure. The AVITA wrist blood pressure monitor BPM17 has passed the requirements of the International Protocol revision 2010, and hence can be recommended for home use in adults.

Validation of the Andon KD-5851 upper arm blood pressure monitor, for self-measurement according to the European Society of Hypertension International Protocol revision 2010.

PubMed

Wu, Lili; Jiao, Yinghui; Wang, Chengdong; Chen, Lei; Di, Dalin; Zhang, Haiyan

2015-08-01

This study aimed to validate the Andon KD-5851 upper arm blood pressure (BP) monitor according to the European Society of Hypertension International Protocol (ESH-IP) revision 2010. A total of 33 eligible participants were included in the study. Sequential measurements of BPs were performed using a mercury sphygmomanometer and the device, and the data analysis was carried out following precisely the ESH-IP revision 2010. The device had 82, 98, and 99 measurements within 5, 10, and 15 mmHg for systolic blood pressure and 85, 95, and 99 measurements for diastolic blood pressure, respectively. The average device-observer difference was -0.53±4.00 mmHg for systolic blood pressure and -1.15±4.06 mmHg for diastolic blood pressure. The device passed all the criteria according to the ESH-IP revision 2010. According to the validation results on the basis of the ESH-IP revision 2010, the Andon KD-5851 upper arm BP monitor can be recommended for self/home measurement in adults. Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved.

Variation in population levels of sedentary time in European adults according to cross-European studies: a systematic literature review within DEDIPAC.

PubMed

Loyen, Anne; Verloigne, Maïté; Van Hecke, Linde; Hendriksen, Ingrid; Lakerveld, Jeroen; Steene-Johannessen, Jostein; Koster, Annemarie; Donnelly, Alan; Ekelund, Ulf; Deforche, Benedicte; De Bourdeaudhuij, Ilse; Brug, Johannes; van der Ploeg, Hidde P

2016-06-28

Sedentary behaviour is increasingly recognized as a public health risk that needs to be monitored at the population level. Across Europe, there is increasing interest in assessing population levels of sedentary time. This systematic literature review aims to provide an overview of all existing cross-European studies that measure sedentary time in adults, to describe the variation in population levels across these studies and to discuss the impact of assessment methods. Six literature databases (PubMed, EMBASE, CINAHL, PsycINFO, SportDiscus and OpenGrey) were searched, supplemented with backward- and forward tracking and searching authors' and experts' literature databases. Articles were included if they reported on observational studies measuring any form of sedentary time in the general population in two or more European countries. Each record was reviewed, extracted and assessed by two independent researchers, and disagreements were resolved by a third researcher. The review protocol of this review is registered in the PROSPERO database under registration number CRD42014010335. Of the 9,756 unique articles that were identified in the search, twelve articles were eligible for inclusion in this review, reporting on six individual studies and three Eurobarometer surveys. These studies represented 2 to 29 countries, and 321 to 65,790 participants. Eleven studies focused on total sedentary time, while one studied screen time. The majority of studies used questionnaires to assess sedentary time, while two studies used accelerometers. Total sedentary time was reported most frequently and varied from 150 (median) to 620 (mean) minutes per day across studies and countries. One third of European countries were not included in any of the studies. Objective measures of European adults are currently limited, and most studies used single-item self-reported questions without assessing sedentary behaviour types or domains. Findings varied substantially between studies, meaning that population levels of sedentary time in European adults are currently unknown. In general, people living in northern Europe countries appear to report more sedentary time than southern Europeans. The findings of this review highlight the need for standardisation of the measurement methods and the added value of cross-European surveillance of sedentary behaviour.

Trends in the number and the quality of trial protocols involving children submitted to a French Institutional Review Board.

PubMed

Gautier, Isabelle; Janiaud, Perrine; Rollet, Nelly; André, Nicolas; Tsimaratos, Michel; Cornu, Catherine; Malik, Salma; Gentile, Stéphanie; Kassaï, Behrouz

2017-08-23

There is a great need for high quality clinical research for children. The European Pediatric Regulation aimed to improve the quality of clinical trials in order to increase the availability of treatments for children. The main purpose of this study was to assess the evolution of both the number and the quality of pediatric trial protocols that were submitted to a French Institutional Review Board (IRB00009118) before and after the initiation of the EU Pediatric Regulation. All protocols submitted to the IRB00009118 between 2003 and 2014 and conducting research on subjects under eighteen years of age were eligible. The quality of randomized clinical trials was assessed according to the guidelines developed by the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) Network and ranked using the Jadad score. Out of 622 protocols submitted to the Institutional Review Board (IRB), 21% (133/622) included children. Among these 133 pediatric protocols, the number of submitted pediatric protocols doubled between the two studied periods. From 2003 to 2008, 47 protocols including 21 institutionally sponsored were submitted to the IRB and from 2009 until 2014, 86 protocols including 48 institutionally sponsored were submitted. No significant trend was observed on the quality of RCTs. The overall median score of RCTs on the Jadad scale was high (3.5), 70.0% of protocols had a Jadad score ≥ 3, and 30.0% had a score < 3. Following the EU Pediatric Regulation, the number of pediatric protocols submitted to the IRB00009118 tends to increase, but no change was noticed regarding their quality.

Validation of the Grandway MD2301 digital automatic blood pressure monitor according to the European Society of Hypertension International Protocol.

PubMed

Chen, Wan; Zeng, Zhao-Lin; Bing, Sen; Li, Lin-Yi; Wang, Rui; Wan, Yi

2016-08-01

The aim of the present study was to validate the Grandway MD2301 digital automatic blood pressure monitor according to the European Society of Hypertension International Protocol (ESH-IP) revision 2010. The ESH-IP revision 2010 for the validation of blood pressure-measuring devices in adults was followed precisely. Systolic and diastolic blood pressure (SBP and DBP, respectively) were measured sequentially in 33 adult patients and compared with a standard mercury sphygmomanometer (two observers). A total of 99 comparison pairs were obtained. The device produced 78, 95 and 99 measurements within 5, 10, and 15 mmHg for SBP and 83, 96, and 99 for DBP, respectively. The average device-observer difference was -1.81±4.22 mmHg for SBP and -0.15±3.93 mmHg for DBP. All of the data were within the standards requirements to pass the testing. The Grandway MD2301 digital automatic blood pressure monitor meets the standards of the ESH-IP revision 2010 and can be recommended for self/home measurement in the general population.

Protocol update and preliminary results of EACVI/HFA Cardiac Oncology Toxicity (COT) Registry of the European Society of Cardiology.

PubMed

Lancellotti, Patrizio; Galderisi, Maurizio; Donal, Erwan; Edvardsen, Thor; Popescu, Bogdan A; Farmakis, Dimitrios; Filippatos, Gerasimos; Habib, Gilbert; Lestuzzi, Chiara; Santoro, Ciro; Moonen, Marie; Jerusalem, Guy; Andarala, Maryna; Anker, Stefan D

2017-08-01

European Association of Cardiovascular Imaging/Heart Failure Association Cardiac Oncology Toxicity Registry was launched in October 2014 as a European Society of Cardiology multicentre registry of breast cancer patients referred to imaging laboratories for routine surveillance, suspected, or confirmed anticancer drug-related cardiotoxicity (ADRC). After a pilot phase (1 year recruitment and 1 year follow-up), some changes have been made to the protocol (version 1.0) and electronic case report form. Main changes of the version 2.0 concerned exclusion criteria, registry duration, and clarification of the population characteristics. Breast cancer radiotherapy has been removed as an exclusion criterion, which involves now only history of a pre-chemotherapy left ventricular dysfunction. The period for long-term registry recruitment has been reduced (December 2017), but the target study population was extended to 3000 patients. The characteristics of the population are now better defined: patients seen in an imaging lab, which will include patients undergoing chemotherapy with associated targeted therapy or no targeted therapy, at increased risk of ADRC. In total, 1294 breast cancer patients have been enrolled, and 783 case report forms locked from October 2014 to November 2016. Of these, 481 (61.4%) were seen at first evaluation and 302 (38.6%) while on oncologic treatment with anticancer drugs. Fifty-two patients (17.2%) were not in targeted therapies, 191 (63.3%) were ongoing targeted therapy, and 59 (19.5%) had completed it. Twenty-three (2.9%) patients had a suspected diagnosis and 35 (4.5%) a confirmed diagnosis of ADRC. Arterial hypertension was the most prevalent cardiovascular risk factor (29.2%) followed by diabetes (6.1%). Previous history of heart failure accounted for 0.5%, whereas previous cardiac disease was identified in 6.3% of population. The changes of the original protocol of the COT Registry and first update allow a first glance to the panorama of cardiovascular characteristics of breast cancer patients enrolled. © 2017 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of the European Society of Cardiology.

Effects of long-term exposure to air pollution on natural-cause mortality: an analysis of 22 European cohorts within the multicentre ESCAPE project.

PubMed

Beelen, Rob; Raaschou-Nielsen, Ole; Stafoggia, Massimo; Andersen, Zorana Jovanovic; Weinmayr, Gudrun; Hoffmann, Barbara; Wolf, Kathrin; Samoli, Evangelia; Fischer, Paul; Nieuwenhuijsen, Mark; Vineis, Paolo; Xun, Wei W; Katsouyanni, Klea; Dimakopoulou, Konstantina; Oudin, Anna; Forsberg, Bertil; Modig, Lars; Havulinna, Aki S; Lanki, Timo; Turunen, Anu; Oftedal, Bente; Nystad, Wenche; Nafstad, Per; De Faire, Ulf; Pedersen, Nancy L; Östenson, Claes-Göran; Fratiglioni, Laura; Penell, Johanna; Korek, Michal; Pershagen, Göran; Eriksen, Kirsten Thorup; Overvad, Kim; Ellermann, Thomas; Eeftens, Marloes; Peeters, Petra H; Meliefste, Kees; Wang, Meng; Bueno-de-Mesquita, Bas; Sugiri, Dorothea; Krämer, Ursula; Heinrich, Joachim; de Hoogh, Kees; Key, Timothy; Peters, Annette; Hampel, Regina; Concin, Hans; Nagel, Gabriele; Ineichen, Alex; Schaffner, Emmanuel; Probst-Hensch, Nicole; Künzli, Nino; Schindler, Christian; Schikowski, Tamara; Adam, Martin; Phuleria, Harish; Vilier, Alice; Clavel-Chapelon, Françoise; Declercq, Christophe; Grioni, Sara; Krogh, Vittorio; Tsai, Ming-Yi; Ricceri, Fulvio; Sacerdote, Carlotta; Galassi, Claudia; Migliore, Enrica; Ranzi, Andrea; Cesaroni, Giulia; Badaloni, Chiara; Forastiere, Francesco; Tamayo, Ibon; Amiano, Pilar; Dorronsoro, Miren; Katsoulis, Michail; Trichopoulou, Antonia; Brunekreef, Bert; Hoek, Gerard

2014-03-01

Few studies on long-term exposure to air pollution and mortality have been reported from Europe. Within the multicentre European Study of Cohorts for Air Pollution Effects (ESCAPE), we aimed to investigate the association between natural-cause mortality and long-term exposure to several air pollutants. We used data from 22 European cohort studies, which created a total study population of 367,251 participants. All cohorts were general population samples, although some were restricted to one sex only. With a strictly standardised protocol, we assessed residential exposure to air pollutants as annual average concentrations of particulate matter (PM) with diameters of less than 2.5 μm (PM2.5), less than 10 μm (PM10), and between 10 μm and 2.5 μm (PMcoarse), PM2.5 absorbance, and annual average concentrations of nitrogen oxides (NO2 and NOx), with land use regression models. We also investigated two traffic intensity variables-traffic intensity on the nearest road (vehicles per day) and total traffic load on all major roads within a 100 m buffer. We did cohort-specific statistical analyses using confounder models with increasing adjustment for confounder variables, and Cox proportional hazards models with a common protocol. We obtained pooled effect estimates through a random-effects meta-analysis. The total study population consisted of 367,251 participants who contributed 5,118,039 person-years at risk (average follow-up 13.9 years), of whom 29,076 died from a natural cause during follow-up. A significantly increased hazard ratio (HR) for PM2.5 of 1.07 (95% CI 1.02-1.13) per 5 μg/m(3) was recorded. No heterogeneity was noted between individual cohort effect estimates (I(2) p value=0.95). HRs for PM2.5 remained significantly raised even when we included only participants exposed to pollutant concentrations lower than the European annual mean limit value of 25 μg/m(3) (HR 1.06, 95% CI 1.00-1.12) or below 20 μg/m(3) (1.07, 1.01-1.13). Long-term exposure to fine particulate air pollution was associated with natural-cause mortality, even within concentration ranges well below the present European annual mean limit value. European Community's Seventh Framework Program (FP7/2007-2011). Copyright © 2014 Elsevier Ltd. All rights reserved.

Negative Impact and Positive Value in Caregiving: Validation of the COPE Index in a Six-Country Sample of Carers

ERIC Educational Resources Information Center

Balducci, Cristian; Mnich, Eva; McKee, Kevin J.; Lamura, Giovanni; Beckmann, Anke; Krevers, Barbro; Wojszel, Z. Beata; Nolan, Mike; Prouskas, Constantinos; Bien, Barbara; Oberg, Birgitta

2008-01-01

Purpose: The present study attempts to further validate the COPE Index on a large sample of carers drawn from six European countries. Design and Methods: We used a cross-sectional survey, with approximately 1,000 carers recruited in each of six countries by means of a common standard evaluation protocol. Our saturation recruitment of a designated…

Might digital drains speed up the time to thoracic drain removal?

PubMed

Afoke, Jonathan; Tan, Carol; Hunt, Ian; Zakkar, Mustafa

2014-07-01

A best evidence topic in thoracic surgery was written according to a structured protocol. The question addressed was: might digital drains speed up the time to thoracic drain removal in terms of time till chest drain removal, hospital stay and overall cost? A total of 296 papers were identified as a result of the search as described below. Of these, five papers provided the best evidence to answer the clinical question. The author, date and country of publication, patient group studied, study type, relevant outcomes, results and study weaknesses of the papers are tabulated. A literature search revealed that several single-centre prospective randomized studies have shown significantly earlier removal of chest drains with digital drains ranging between 0.8 and 2.1 days sooner. However, there was heterogeneity in studies in the management protocol of chest drains in terms of the use of suction, number of drains and assessment for drain removal. Some protocols such as routinely keeping drains irrespective of the presence of air leak or drain output may have skewed results. Differences in exclusion criteria and protocols for discharging home with portable devices may have biased results. Due to heterogeneity in the management protocol of chest drains, there is conflicting evidence regarding hospital stay. The limited data on cost suggest that there may be significantly lower postoperative costs in the digital drain group. All the studies were single-centre series generally including patients with good preoperative lung function tests. Further larger studies with more robust chest drain management protocols are required especially to assess length of hospital stay, cost and whether the results are applicable to a larger patient population. © The Author 2014. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Clinical use of adipose-derived stem cells: European legislative issues.

PubMed

Raposio, Edoardo; Ciliberti, RosaGemma

2017-12-01

With this study we analyse the current European legislation in order to provide guidance for regenerative medicine professionals on correct Adipose-derived Stem Cells (ASCs) isolation and use protocols for clinical applications. The European Medicines Agency (EMA) considers that ASCs does not fall within the definition of an advanced therapy medicinal product if the cells have not been subjected to a substantial manipulation, and the mode of action of the cells (contribute to and enhance tissue renewal and turnover of the subcutaneous tissue) is considered to be homologous to the donor fat tissue. Collagenase digestion, as well as cell culturing, is considered to be a substantial manipulation. Only transplantation of a non-manipulated tissue to another location in the same anatomical or histological environment is considered to be homologous. According to these considerations, ASCs should be not-cultured, isolated mechanically and used only in the subcutaneous tissue.

Gender equality in the work of local research ethics committees in Europe: a study of practice in five countries.

PubMed

Moerman, C J; Haafkens, J A; Söderström, M; Rásky, E; Maguire, P; Maschewsky-Schneider, U; Norstedt, M; Hahn, D; Reinerth, H; McKevitt, N

2007-02-01

Funding organisations and research ethics committees (RECs) should play a part in strengthening attention to gender equality in clinical research. In the research policy of European Union (EU), funding measures have been taken to realise this, but such measures are lacking in the EU policy regarding RECs. To explore how RECs in Austria, Germany, Ireland, The Netherlands and Sweden deal with gender equality issues by asking two questions: (1) Do existing procedures promote representation of women and gender expertise in the committee? (2) How are sex and gender issues dealt with in protocol evaluation? Two RECs were selected from each country. Data were obtained through interviews with key informants and content analysis of relevant documents (regulations, guidelines and review tools in use in 2003). All countries have rules (mostly informal) to ensure the presence of women on RECs; gender expertise is not required. Drug study protocols are carefully evaluated, sometimes on a formal basis, as regards the inclusion of women of childbearing age. The reason for excluding either one of the sexes or including specific groups of women or making a gender-specific risk-benefit analysis are investigated by some RECs. Such measures are, however, neither defined in the regulations nor integrated in review tools. The RECs investigated in five European member states are found to pay limited attention to gender equality in their working methods and, in particular in protocol evaluation. Policy and regulations of EU are needed to strengthen attention to gender equality in the work of RECs.

Validation of the AVITA BPM63S upper arm blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010.

PubMed

Kang, Yuan-Yuan; Zeng, Wei-Fang; Liu, Ming; Li, Yan; Wang, Ji-Guang

2014-02-01

The present study aimed to evaluate the accuracy of the AVITA BPM63S upper arm blood pressure monitor for home blood pressure monitoring according to the International Protocol of the European Society of Hypertension revision 2010. Systolic and diastolic blood pressures were sequentially measured in 33 adult Chinese (14 women, mean age of 47 years) using a mercury sphygmomanometer (two observers) and the AVITA BPM63S device (one supervisor). Ninety-nine pairs of comparisons were obtained from 33 participants for judgments in two parts with three grading phases. All the blood pressure requirements were fulfilled. The AVITA BPM63S device achieved the targets in part 1 of the validation study. The number of absolute differences between device and observers within 5, 10, and 15 mmHg was 68/99, 89/99, and 96/99, respectively, for systolic blood pressure, and 75/99, 95/99, and 97/99, respectively, for diastolic blood pressure. The device also achieved the criteria in part 2 of the validation study. Twenty-four and 25 participants for systolic and diastolic blood pressure, respectively, had at least two of the three device-observers differences within 5 mmHg (required ≥24). One and two participants for systolic and diastolic blood pressure, respectively, had all three device-observers differences greater than 5 mmHg. The AVITA BPM63S automated oscillometric upper arm blood pressure monitor has passed the requirements of the International Protocol revision 2010, and hence can be recommended for blood pressure measurement at home in adults.

Validation of the Konsung QD217A for clinical use and self-measurement according to the European Society of Hypertension International Protocol.

PubMed

Wu, Ning; Zhang, Xuezhong; Wang, Wen; Zhang, Hongye

2015-08-01

This study aimed to evaluate the accuracy of the automated oscillometric upper arm blood pressure (BP) monitor Konsung QD217A for home BP monitoring according to the European Society of Hypertension International Protocol revision 2010. Three trained observers validated the performance of these devices by comparing the measurements obtained from these devices with those taken using a standard mercury sphygmomanometer. Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were sequentially measured in 33 participants using a standard mercury sphygmomanometer and the Konsung QD217A device. A total of 99 pairs of comparisons were obtained from 33 participants. The QD217A device achieved the targets in part 1 of the validation study. The number of absolute differences between the device and the observers within a range of 5, 10 and 15 mmHg was 70/99, 92/99 and 96/99, respectively, for SBP and 80/99, 94/99 and 99/99, respectively, for DBP. The device also achieved the targets in part 2 of the validation study. A total of 27 and 31 participants for SBP and DBP, respectively, showed at least two of the three device-observers differences within 5 mmHg (required≥24). The number of participants without device-observer difference within 5 mmHg was one for SBP and one for DBP (required≤3). The Konsung upper arm BP monitor QD217A has passed the International Protocol requirements and it can be recommended for clinical use and self-measurement in adults. Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved.

Validation of the YuWell YE690A upper-arm blood pressure monitor, for clinic use and self-measurement, according to the European Society of Hypertension International Protocol revision 2010.

PubMed

Chen, Qi; Lei, Lei; Li, Yan; Wang, Ji-Guang

2017-10-01

The present study aimed to evaluate the accuracy of the automated oscillometric upper-arm blood pressure monitor YuWell YE690A for blood pressure measurement according to the International Protocol of the European Society of Hypertension revision 2010. Systolic and diastolic blood pressures were measured sequentially in 33 adult Chinese (12 women, 44.2 years of mean age) using a mercury sphygmomanometer (two observers) and the YE690A device (one supervisor). A total of 99 pairs of comparisons were obtained from 33 participants for judgments in two parts with three grading phases. All the blood pressure requirements were fulfilled. The YuWell YE690A device achieved the targets in part 1 of the validation study. The number of absolute differences between device and observers within 5, 10, and 15 mmHg was 79/99, 96/99, and 97/99, respectively, for systolic blood pressure and 72/99, 95/99, and 98/99, respectively, for diastolic blood pressure. The device also fulfilled the criteria in part 2 of the validation study. Thirty-one and 25 participants for systolic and diastolic blood pressure, respectively, had at least two of the three device-observer differences within 5 mmHg (required ≥24). No participant for systolic and two participants for diastolic blood pressure had all the three device-observer comparisons greater than 5 mmHg. The YuWell blood pressure monitor YE690A has passed the requirements of the International Protocol revision 2010 and hence can be recommended for blood pressure measurement in adults.

Communication in a Human biomonitoring study: Focus group work, public engagement and lessons learnt in 17 European countries.

PubMed

Exley, Karen; Cano, Noemi; Aerts, Dominique; Biot, Pierre; Casteleyn, Ludwine; Kolossa-Gehring, Marike; Schwedler, Gerda; Castaño, Argelia; Angerer, Jürgen; Koch, Holger M; Esteban, Marta; Schoeters, Greet; Den Hond, Elly; Horvat, Milena; Bloemen, Louis; Knudsen, Lisbeth E; Joas, Reinhard; Joas, Anke; Dewolf, Marie-Christine; Van de Mieroop, Els; Katsonouri, Andromachi; Hadjipanayis, Adamos; Cerna, Milena; Krskova, Andrea; Becker, Kerstin; Fiddicke, Ulrike; Seiwert, Margarete; Mørck, Thit A; Rudnai, Peter; Kozepesy, Szilvia; Cullen, Elizabeth; Kellegher, Anne; Gutleb, Arno C; Fischer, Marc E; Ligocka, Danuta; Kamińska, Joanna; Namorado, Sónia; Reis, M Fátima; Lupsa, Ioana-Rodica; Gurzau, Anca E; Halzlova, Katarina; Jajcaj, Michal; Mazej, Darja; Tratnik, Janja Snoj; Huetos, Olga; López, Ana; Berglund, Marika; Larsson, Kristin; Sepai, Ovnair

2015-08-01

A communication strategy was developed by The Consortium to Perform Human Biomonitoring on a European Scale (COPHES), as part of its objectives to develop a framework and protocols to enable the collection of comparable human biomonitoring data throughout Europe. The framework and protocols were tested in the pilot study DEMOCOPHES (Demonstration of a study to Coordinate and Perform Human biomonitoring on a European Scale). The aims of the communication strategy were to raise awareness of human biomonitoring, encourage participation in the study and to communicate the study results and their public health significance. It identified the audiences and key messages, documented the procedure for dissemination of results and was updated as the project progressed. A communication plan listed the tools and materials such as press releases, flyers, recruitment letters and information leaflets required for each audience with a time frame for releasing them. Public insight research was used to evaluate the recruitment material, and the feedback was used to improve the documents. Dissemination of results was coordinated in a step by step approach by the participating countries within DEMOCOPHES, taking into account specific national messages according to the needs of each country. Participants received individual results, unless they refused to be informed, along with guidance on what the results meant. The aggregate results and policy recommendations were then communicated to the general public and stakeholders, followed by dissemination at European level. Several lessons were learnt that may assist other future human biomonitoring studies. Recruitment took longer than anticipated and so social scientists, to help with community engagement, should be part of the research team from the start. As a European study, involving multiple countries, additional considerations were needed for the numerous organisations, different languages, cultures, policies and priorities. Therefore, communication documents should be seen as templates with essential information clearly indicated and the option for each country to tailor the material to reflect these differences. Future studies should consider setting up multidisciplinary networks of medical professionals and communication experts, and holding training workshops to discuss the interpretation of results and risk communication. Publicity and wide dissemination of the results helped to raise awareness of human biomonitoring to the general public, policy makers and other key stakeholders. Effective and timely communication, at all stages of a study, is essential if the potential of human biomonitoring research to improve public health is to be realised. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

Evaluation of a new chest tube removal protocol using digital air leak monitoring after lobectomy: a prospective randomised trial.

PubMed

Brunelli, Alessandro; Salati, Michele; Refai, Majed; Di Nunzio, Luca; Xiumé, Francesco; Sabbatini, Armando

2010-01-01

The objective of this randomised trial was to assess the effectiveness of a new fast-track chest tube removal protocol taking advantage of digital monitoring of air leak compared to a traditional protocol using visual and subjective assessment of air leak (bubbles). One hundred and sixty-six patients submitted to pulmonary lobectomy for lung cancer were randomised in two groups with different chest tube removal protocols: (1) in the new protocol, chest tube was removed based on digitally recorded measurements of air leak flow; (2) in the traditional protocol, the chest tube removal was based on an instantaneous assessment of air leak during daily rounds. The two groups were compared in terms of chest tube duration, hospital stay and costs. The two groups were well matched for several preoperative and operative variables. Compared to the traditional protocol, the new digital recording protocol showed mean reductions in chest tube duration (p=0.0007), hospital stay (p=0.007) of 0.9 day, and a mean cost saving of euro 476 per patient (p=0.008). In the new chest tube removal protocol, 51% of patients had their chest tube removed by the second postoperative day versus only 12% of those in the traditional protocol. The application of a chest tube removal protocol using a digital drainage unit featuring a continuous recording of air leak was safe and cost effective. Although future studies are warranted to confirm these results in other settings, the use of this new protocol is now routinely applied in our practice. Copyright 2009 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved.

Validation of the custo screen pediatric blood pressure monitor according to the European Society of Hypertension International Protocol revision 2010.

PubMed

Beime, Beate; Deutsch, Cornelia; Krüger, Ralf; Wolf, Andreas; Müller, Peter; Hammel, Gertrud; Bramlage, Peter

2017-05-01

The purpose of the study was to validate the ambulatory blood pressure monitoring (ABPM) device custo screen pediatric in children aged 3 to 12 years according to the International Protocol of the European Society of Hypertension (ESH-IP revision 2010). Thirty-three children were included and systolic and diastolic blood pressure measurements were performed according to the ESH-IP. The protocol was modified for children considering data from the German Health Interview and Examination Survey for Children and Adolescents (KIGGS). The custo screen pediatric met all the requirements of the ESH-IP. The mean difference between the test device and the reference was -1.4 ± 3.0 mmHg for systolic blood pressure (SBP) and -0.7 ± 3.2 mmHg for diastolic blood pressure (DBP). For SBP and DBP, all 99 measurements were within the absolute difference of 10 mmHg between the test device and the reference. As to part 2 of the protocol, for DBP in all subjects, two out of three measurements were within 5 mmHg between the device and the standard, whereas for SBP in 32 of 33 subjects, two out of three measurements were within this range. The custo screen pediatric met all criteria of the ESH-IP review 2010, modified for children from 3 to about 12 years, and can be recommended for ABPM in children. What is Known: • Validation of blood pressure measuring devices is essential to provide patients with an accurate blood pressure measuring device. • The majority of devices has not been validated in children. What is New: • Prior to the present validation, study protocol adjustments of ESH-IP review 2010 for children were defined according to German Health Interview and Examination Survey for Children and Adolescents 2013 (KIGGS). • The custo screen pediatric test device met all criteria of ESH-IP revision 2010, modified for children, and can be recommended for ABPM in children aged 3 to about 12 years.

Validation of four devices: Omron M6 Comfort, Omron HEM-7420, Withings BP-800, and Polygreen KP-7670 for home blood pressure measurement according to the European Society of Hypertension International Protocol

PubMed Central

Topouchian, Jirar; Agnoletti, Davide; Blacher¹, Jacques; Youssef, Ahmed; Chahine, Mirna N; Ibanez, Isabel; Assemani, Nathalie; Asmar, Roland

2014-01-01

Background Four oscillometric devices, including the Omron M6 Comfort, Omron HEM-7420, Withings BP-800, and Polygreen KP-7670, designed for self-blood pressure measurement (SBPM) were evaluated according to the European Society of Hypertension (ESH) International Protocol Revision 2010 in four separate studies. Methods The four devices measure brachial blood pressure (BP) using the oscillometric method. The Withings BP-800 has to be connected to an Apple® iOS device such as an iPhone®, iPad®, or iPod®. The ESH International Protocol Revision 2010 includes a total number of 33 subjects. The difference between observer and device BP values was calculated for each measure. Ninety-nine pairs of BP differences were classified into three categories (≤5 mmHg, ≤10 mmHg, ≤15 mmHg). The protocol procedures were followed precisely in each of the four studies. Results All four tested devices passed the validation process. The mean differences between the device and mercury readings were: −1.8±5.1 mmHg and −0.4±2.8 mmHg for systolic and diastolic BP, respectively, using the Omron M6 Comfort device; 2.5±4.6 mmHg and −1.2±4.3 mmHg for the Omron HEM-7420 device; −0.2±5.0 mmHg and 0.4±4.2 mmHg for the Withings BP-800 device; and 3.0±5.3 mmHg and 0.3±5.2 mmHg for the Polygreen KP-7670 device. Conclusion Omron M6 Comfort, Omron HEM-7420, Withings BP-800, and Polygreen KP-7670 readings differing by less than 5 mmHg, 10 mmHg, and 15 mmHg fulfill the ESH International Protocol Revision 2010 requirements, and therefore are suitable for use by patients for SBPM, if used correctly. PMID:24476688

A randomized noninferiority trial of condensed protocols for genetic risk disclosure of Alzheimer's disease.

PubMed

Green, Robert C; Christensen, Kurt D; Cupples, L Adrienne; Relkin, Norman R; Whitehouse, Peter J; Royal, Charmaine D M; Obisesan, Thomas O; Cook-Deegan, Robert; Linnenbringer, Erin; Butson, Melissa Barber; Fasaye, Grace-Ann; Levinson, Elana; Roberts, J Scott

2015-10-01

Conventional multisession genetic counseling is currently recommended when disclosing apolipoprotein E (APOE) genotype for the risk of Alzheimer's disease (AD) in cognitively normal individuals. The objective of this study was to evaluate the safety of brief disclosure protocols for disclosing APOE genotype for the risk of AD. A randomized, multicenter noninferiority trial was conducted at four sites. Participants were asymptomatic adults having a first-degree relative with AD. A standard disclosure protocol by genetic counselors (SP-GC) was compared with condensed protocols, with disclosures by genetic counselors (CP-GC) and by physicians (CP-MD). Preplanned co-primary outcomes were anxiety and depression scales 12 months after disclosure. Three hundred and forty-three adults (mean age 58.3, range 33-86 years, 71% female, 23% African American) were randomly assigned to the SP-GC protocol (n = 115), CP-GC protocol (n = 116), or CP-MD protocol (n = 112). Mean postdisclosure scores on all outcomes were well below cut-offs for clinical concern across protocols. Comparing CP-GC with SP-GC, the 97.5% upper confidence limits at 12 months after disclosure on co-primary outcomes of anxiety and depression ranged from a difference of 1.2 to 2.0 in means (all P < .001 on noninferiority tests), establishing noninferiority for condensed protocols. Results were similar between European Americans and African Americans. These data support the safety of condensed protocols for APOE disclosure for those free of severe anxiety or depression who are actively seeking such information. Copyright © 2015 The Alzheimer's Association. Published by Elsevier Inc. All rights reserved.

Evaluation of Protocol Uniformity Concerning Laparoscopic Cholecystectomy in The Netherlands

PubMed Central

Goossens, Richard H. M.; van Eijk, Daan J.; Lange, Johan F.

2008-01-01

Background Iatrogenic bile duct injury remains a current complication of laparoscopic cholecystectomy. One uniform and standardized protocol, based on the “critical view of safety” concept of Strasberg, should reduce the incidence of this complication. Furthermore, owing to the rapid development of minimally invasive surgery, technicians are becoming more frequently involved. To improve communication between the operating team and technicians, standardized actions should also be defined. The aim of this study was to compare existing protocols for laparoscopic cholecystectomy from various Dutch hospitals. Methods Fifteen Dutch hospitals were contacted for evaluation of their protocols for laparoscopic cholecystectomy. All evaluated protocols were divided into six steps and were compared accordingly. Results In total, 13 hospitals responded—5 academic hospitals, 5 teaching hospitals, 3 community hospitals—of which 10 protocols were usable for comparison. Concerning the trocar positions, only minor differences were found. The concept of “critical view of safety” was represented in just one protocol. Furthermore, the order of clipping and cutting the cystic artery and duct differed. Descriptions of instruments and apparatus were also inconsistent. Conclusions Present protocols differ too much to define a universal procedure among surgeons in The Netherlands. The authors propose one (inter)national standardized protocol, including standardized actions. This uniform standardized protocol has to be officially released and recommended by national scientific associations (e.g., the Dutch Society of Surgery) or international societies (e.g., European Association for Endoscopic Surgery and Society of American Gastrointestinal and Endoscopic Surgeons). The aim is to improve patient safety and professional communication, which are necessary for new developments. PMID:18224485

Validation protocols for blood pressure-measuring devices: status quo and development needs.

PubMed

Beime, Beate; Deutsch, Cornelia; Gomez, Timothy; Zwingers, Thomas; Mengden, Thomas; Bramlage, Peter

2016-02-01

Hypertension is a major risk factor for cardiovascular morbidity and mortality. Therefore, blood pressure self-measuring devices have emerged as valuable tools in patient care and the accuracy of these instruments is of fundamental importance. For this reason, several validation procedures for assessing the efficacy of blood pressure monitoring devices have been developed, including protocols by the Association for the Advancement of Medical Instrumentation, the British Hypertension Society, the German Hypertension League (Prüfsiegelprotokoll), and the International Protocol of the Working Group on Blood Pressure Monitoring of the European Society of Hypertension. In the past, most of the protocols have been reviewed and modified because of experiences gained during the validation studies carried out. However, each shows distinct differences, that is number and characteristics of patients required, blood pressure ranges, and the length of the validation procedure, which may result in unique advantages and/or limitations associated with their use. The continued standardization and evolution of these guidelines is essential to ensure the efficacy of blood pressure-measuring devices marketed for clinical and home use. Here, we aimed to compare four currently used validation protocols and to initiate a discussion on potential future improvements.

A coding variant in RARG confers susceptibility to anthracycline-induced cardiotoxicity in childhood cancer.

PubMed

Aminkeng, Folefac; Bhavsar, Amit P; Visscher, Henk; Rassekh, Shahrad R; Li, Yuling; Lee, Jong W; Brunham, Liam R; Caron, Huib N; van Dalen, Elvira C; Kremer, Leontien C; van der Pal, Helena J; Amstutz, Ursula; Rieder, Michael J; Bernstein, Daniel; Carleton, Bruce C; Hayden, Michael R; Ross, Colin J D

2015-09-01

Anthracyclines are used in over 50% of childhood cancer treatment protocols, but their clinical usefulness is limited by anthracycline-induced cardiotoxicity (ACT) manifesting as asymptomatic cardiac dysfunction and congestive heart failure in up to 57% and 16% of patients, respectively. Candidate gene studies have reported genetic associations with ACT, but these studies have in general lacked robust patient numbers, independent replication or functional validation. Thus, the individual variability in ACT susceptibility remains largely unexplained. We performed a genome-wide association study in 280 patients of European ancestry treated for childhood cancer, with independent replication in similarly treated cohorts of 96 European and 80 non-European patients. We identified a nonsynonymous variant (rs2229774, p.Ser427Leu) in RARG highly associated with ACT (P = 5.9 × 10(-8), odds ratio (95% confidence interval) = 4.7 (2.7-8.3)). This variant alters RARG function, leading to derepression of the key ACT genetic determinant Top2b, and provides new insight into the pathophysiology of this severe adverse drug reaction.

Multi-laboratory validation study of multilocus variable-number tandem repeat analysis (MLVA) for Salmonella enterica serovar Enteritidis, 2015

PubMed Central

Peters, Tansy; Bertrand, Sophie; Björkman, Jonas T; Brandal, Lin T; Brown, Derek J; Erdõsi, Tímea; Heck, Max; Ibrahem, Salha; Johansson, Karin; Kornschober, Christian; Kotila, Saara M; Le Hello, Simon; Lienemann, Taru; Mattheus, Wesley; Nielsen, Eva Møller; Ragimbeau, Catherine; Rumore, Jillian; Sabol, Ashley; Torpdahl, Mia; Trees, Eija; Tuohy, Alma; de Pinna, Elizabeth

2017-01-01

Multilocus variable-number tandem repeat analysis (MLVA) is a rapid and reproducible typing method that is an important tool for investigation, as well as detection, of national and multinational outbreaks of a range of food-borne pathogens. Salmonella enterica serovar Enteritidis is the most common Salmonella serovar associated with human salmonellosis in the European Union/European Economic Area and North America. Fourteen laboratories from 13 countries in Europe and North America participated in a validation study for MLVA of S. Enteritidis targeting five loci. Following normalisation of fragment sizes using a set of reference strains, a blinded set of 24 strains with known allele sizes was analysed by each participant. The S. Enteritidis 5-loci MLVA protocol was shown to produce internationally comparable results as more than 90% of the participants reported less than 5% discrepant MLVA profiles. All 14 participating laboratories performed well, even those where experience with this typing method was limited. The raw fragment length data were consistent throughout, and the inter-laboratory validation helped to standardise the conversion of raw data to repeat numbers with at least two countries updating their internal procedures. However, differences in assigned MLVA profiles remain between well-established protocols and should be taken into account when exchanging data. PMID:28277220

Efficiency of fluorescence in situ hybridization for bacterial cell identification in temporary river sediments with contrasting water content.

PubMed

Fazi, Stefano; Amalfitano, Stefano; Pizzetti, Ilaria; Pernthaler, Jakob

2007-09-01

We studied the efficiency of two hybridization techniques for the analysis of benthic bacterial community composition under varying sediment water content. Microcosms were set up with sediments from four European temporary rivers. Wet sediments were dried, and dry sediments were artificially rewetted. The percentage of bacterial cells detected by fluorescence in situ hybridization with fluorescently monolabeled probes (FISH) significantly increased from dry to wet sediments, showing a positive correlation with the community activity measured via incorporation of (3)H leucine. FISH and signal amplification by catalyzed reporter deposition (CARD-FISH) could significantly better detect cells with low activity in dried sediments. Through the application of an optimized cell permeabilization protocol, the percentage of hybridized cells by CARD-FISH showed comparable values in dry and wet conditions. This approach was unrelated to (3)H leucine incorporation rates. Moreover, the optimized protocol allowed a significantly better visualization of Gram-positive Actinobacteria in the studied samples. CARD-FISH is, therefore, proposed as an effective technique to compare bacterial communities residing in sediments with contrasting water content, irrespective of differences in the activity state of target cells. Considering the increasing frequencies of flood and drought cycles in European temporary rivers, our approach may help to better understand the dynamics of microbial communities in such systems.

The First European Interdisciplinary Ewing Sarcoma Research Summit

PubMed Central

Kovar, Heinrich; Alonso, Javier; Aman, Pierre; Aryee, Dave N. T.; Ban, Jozef; Burchill, Sue A.; Burdach, Stefan; De Alava, Enrique; Delattre, Olivier; Dirksen, Uta; Fourtouna, Argyro; Fulda, Simone; Helman, Lee J.; Herrero-Martin, David; Hogendoorn, Pancras C. W.; Kontny, Udo; Lawlor, Elizabeth R.; Lessnick, Stephen L.; Llombart-Bosch, Antonio; Metzler, Markus; Moriggl, Richard; Niedan, Stephan; Potratz, Jenny; Redini, Françoise; Richter, Günther H. S.; Riedmann, Lucia T.; Rossig, Claudia; Schäfer, Beat W.; Schwentner, Raphaela; Scotlandi, Katia; Sorensen, Poul H.; Staege, Martin S.; Tirode, Franck; Toretsky, Jeffrey; Ventura, Selena; Eggert, Angelika; Ladenstein, Ruth

2012-01-01

The European Network for Cancer Research in Children and Adolescents (ENCCA) provides an interaction platform for stakeholders in research and care of children with cancer. Among ENCCA objectives is the establishment of biology-based prioritization mechanisms for the selection of innovative targets, drugs, and prognostic markers for validation in clinical trials. Specifically for sarcomas, there is a burning need for novel treatment options, since current chemotherapeutic treatment protocols have met their limits. This is most obvious for metastatic Ewing sarcoma (ES), where long term survival rates are still below 20%. Despite significant progress in our understanding of ES biology, clinical translation of promising laboratory results has not yet taken place due to fragmentation of research and lack of an institutionalized discussion forum. To fill this gap, ENCCA assembled 30 European expert scientists and five North American opinion leaders in December 2011 to exchange thoughts and discuss the state of the art in ES research and latest results from the bench, and to propose biological studies and novel promising therapeutics for the upcoming European EWING2008 and EWING2012 clinical trials. PMID:22662320

The first European interdisciplinary ewing sarcoma research summit.

PubMed

Kovar, Heinrich; Alonso, Javier; Aman, Pierre; Aryee, Dave N T; Ban, Jozef; Burchill, Sue A; Burdach, Stefan; De Alava, Enrique; Delattre, Olivier; Dirksen, Uta; Fourtouna, Argyro; Fulda, Simone; Helman, Lee J; Herrero-Martin, David; Hogendoorn, Pancras C W; Kontny, Udo; Lawlor, Elizabeth R; Lessnick, Stephen L; Llombart-Bosch, Antonio; Metzler, Markus; Moriggl, Richard; Niedan, Stephan; Potratz, Jenny; Redini, Françoise; Richter, Günther H S; Riedmann, Lucia T; Rossig, Claudia; Schäfer, Beat W; Schwentner, Raphaela; Scotlandi, Katia; Sorensen, Poul H; Staege, Martin S; Tirode, Franck; Toretsky, Jeffrey; Ventura, Selena; Eggert, Angelika; Ladenstein, Ruth

2012-01-01

The European Network for Cancer Research in Children and Adolescents (ENCCA) provides an interaction platform for stakeholders in research and care of children with cancer. Among ENCCA objectives is the establishment of biology-based prioritization mechanisms for the selection of innovative targets, drugs, and prognostic markers for validation in clinical trials. Specifically for sarcomas, there is a burning need for novel treatment options, since current chemotherapeutic treatment protocols have met their limits. This is most obvious for metastatic Ewing sarcoma (ES), where long term survival rates are still below 20%. Despite significant progress in our understanding of ES biology, clinical translation of promising laboratory results has not yet taken place due to fragmentation of research and lack of an institutionalized discussion forum. To fill this gap, ENCCA assembled 30 European expert scientists and five North American opinion leaders in December 2011 to exchange thoughts and discuss the state of the art in ES research and latest results from the bench, and to propose biological studies and novel promising therapeutics for the upcoming European EWING2008 and EWING2012 clinical trials.

Timeline of Actions on HFCs

EPA Pesticide Factsheets

The Kigali amendment to phase down HFCs was the result of years of negotiation by parties to the Montreal Protocol, with numerous HFC amendment proposals submitted by North America, Island States, India, and the European Union.

Improving Distress in Dialysis (iDiD): A tailored CBT self-management treatment for patients undergoing dialysis.

PubMed

Hudson, Joanna L; Moss-Morris, Rona; Game, David; Carroll, Amy; Chilcot, Joseph

2016-12-01

There is significant psychological distress in adults with end-stage kidney disease (ESKD). However, psychological treatments tailored to address the unique challenges of kidney failure are absent. We identified psychological correlates of distress in ESKD to develop a cognitive-behavioural therapy (CBT) treatment protocol that integrates the mental health needs of patients alongside their illness self-management demands. Studies which examined relationships between distress and psychological factors that apply in the context of ESKD including: health threats, cognitive illness representations and illness management behaviours were narratively reviewed. Review findings were translated into a CBT formulation model to inform the content of a renal-specific seven session CBT treatment protocol, which was commented on and refined by patient representatives. Health threats related to distress were grouped into four themes including: acute ESKD events, loss of role, uncertainty and illness self-management. Having pessimistic illness and treatment perceptions were associated with elevated distress. Non-adherence and avoidance behaviours were related to feelings of distress, whereas cognitive reappraisal, acceptance, social support and assertiveness were associated with less distress. The dialysis-specific CBT formulation identifies the importance of targeting ESKD-specific correlates of distress to allow the delivery of integrated mental and physical health care. The 'Improving Distress in Dialysis (iDiD)' treatment protocol now requires further evaluation in terms of content, feasibility and potential efficacy. © 2016 European Dialysis and Transplant Nurses Association/European Renal Care Association.

Development of an efficient real-time quantitative PCR protocol for detection of Xanthomonas arboricola pv. pruni in Prunus species.

PubMed

Palacio-Bielsa, Ana; Cubero, Jaime; Cambra, Miguel A; Collados, Raquel; Berruete, Isabel M; López, María M

2011-01-01

Xanthomonas arboricola pv. pruni, the causal agent of bacterial spot disease of stone fruit, is considered a quarantine organism by the European Union and the European and Mediterranean Plant Protection Organization (EPPO). The bacterium can undergo an epiphytic phase and/or be latent and can be transmitted by plant material, but currently, only visual inspections are used to certify plants as being X. arboricola pv. pruni free. A novel and highly sensitive real-time TaqMan PCR detection protocol was designed based on a sequence of a gene for a putative protein related to an ABC transporter ATP-binding system in X. arboricola pv. pruni. Pathogen detection can be completed within a few hours with a sensitivity of 10(2) CFU ml(-1), thus surpassing the sensitivity of the existing conventional PCR. Specificity was assessed for X. arboricola pv. pruni strains from different origins as well as for closely related Xanthomonas species, non-Xanthomonas species, saprophytic bacteria, and healthy Prunus samples. The efficiency of the developed protocol was evaluated with field samples of 14 Prunus species and rootstocks. For symptomatic leaf samples, the protocol was very efficient even when washed tissues of the leaves were directly amplified without any previous DNA extraction. For samples of 117 asymptomatic leaves and 285 buds, the protocol was more efficient after a simple DNA extraction, and X. arboricola pv. pruni was detected in 9.4% and 9.1% of the 402 samples analyzed, respectively, demonstrating its frequent epiphytic or endophytic phase. This newly developed real-time PCR protocol can be used as a quantitative assay, offers a reliable and sensitive test for X. arboricola pv. pruni, and is suitable as a screening test for symptomatic as well as asymptomatic plant material.

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

PubMed Central

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

2013-01-01

Objective To describe the characteristics of randomized controlled clinical trials (RCT) on cancer drugs conducted in Spain between 1999 and 2003 based on their protocols. Methods We conducted an observational retrospective cohort study to identify the protocols of RCTs on cancer drugs authorized by the Agencia Española del Medicamento y Productos Sanitarios (AEMPS) (Spanish Agency for Medicines and Medical Devices) during 1999-2003. A descriptive analysis was completed and the association between variables based on the study setting and sponsorship were assessed. Results We identified a total of 303 protocols, which included 176,835 potentially eligible patients. Three-quarter of the studies were internationally-based, 61.7% were phase III, and 76.2% were sponsored by pharmaceutical companies. The most frequently assessed outcomes were response rate (24.7%), overall survival (20.7%), and progression-free survival (14.5%). Of all protocols, 10.6% intended to include more than 1000 patients (mean: 2442, SD: 2724). Compared with their national counterparts, internationally-based studies were significantly larger (p<0.001) and were more likely to implement centralized randomization (p<0.001), blinding of the intervention (p<0.001), and survival as primary outcome (p<0.001). Additionally, most internationally-based studies were sponsored by pharmaceutical companies (p<0.01). In a high percentage of protocols, the available information was not explicit enough to assess the validity of each trial. Compared to other European countries, the proportion of Spanish cancer drugs protocols registered at www.clinicaltrials.gov (7%) was lower. Conclusion RCTs on cancer drugs conducted in Spain between 1999 and 2003 were more likely to be promoted by pharmaceutical companies rather than by non-profit national groups. The former were more often part of international studies, which generally had better methodological quality than national ones. There are some worldwide on-going initiatives that aim to increase the transparency and quality of future research. PMID:24236154

Impact of Prostatic-specific Antigen Threshold and Screening Interval in Prostate Cancer Screening Outcomes: Comparing the Swedish and Finnish European Randomised Study of Screening for Prostate Cancer Centres.

PubMed

Saarimäki, Lasse; Hugosson, Jonas; Tammela, Teuvo L; Carlsson, Sigrid; Talala, Kirsi; Auvinen, Anssi

2017-08-10

The European Randomised Study of Screening for Prostate Cancer trial has shown a 21% reduction in prostate cancer (PC) mortality with prostate-specific antigen (PSA)-based screening. Sweden used a 2-yr screening interval and showed a larger mortality reduction than Finland with a 4-yr interval and higher PSA cut-off. To evaluate the impact of screening interval and PSA cut-off on PC detection and mortality. We analysed the core age groups (55-69 yr at entry) of the Finnish (N=31 866) and Swedish (N=5901) screening arms at 13 yr and 16 yr of follow-up. Sweden used a screening interval of 2 yr and a PSA cut-off of 3.0ng/ml, while in Finland the screening interval was 4 yr and the PSA cut-off 4.0ng/ml (or PSA 3.0-3.9ng/ml with free PSA<16%). We compared PC detection rate and PC mortality between the Finnish and Swedish centres and estimated the impact of different screening protocols. If the Swedish screening protocol had been followed in Finland, 122 additional PC cases would have been diagnosed at screening, 84% of which would have been low-risk cancers, and four leading to PC death. In contrast, if a lower PSA threshold had been applied in Finland, at least 127 additional PC would have been found, with 19 PC deaths. The small number of deaths among cases that would have been potentially detectable in Finland with the Swedish protocol (or those that would have been missed in Sweden with the Finnish approach) is unlikely to explain the differences in mortality in this long of a follow-up. A prostate-specific antigen threshold of 3ng/ml versus 4ng/ml or a screening interval of 2 yr instead of 4 yr is unlikely to explain the larger mortality reduction achieved in Sweden compared with Finland. Copyright © 2017 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Validation of the Medipro MediCare 100f upper arm blood pressure monitor, for self-measurement, according to the European Society of Hypertension International Protocol revision 2010.

PubMed

Yi, Jun; Wan, Yi; Pan, Feng; Yu, Xiaorong; Zhao, Huadong; Shang, Fujun; Xu, Yongyong

2011-08-01

The validation of sphygmomanometer is important in accurate blood pressure measurement. This study presents the validation results by the Medipro MediCare 100f upper arm blood pressure monitor according to the European Society of Hypertension International Protocol (ESH-IP) revision 2010. The ESH-IP revision 2010 for the validation of blood pressure measuring devices in adults was followed precisely. A total of 99 couples of test device and reference blood pressure measurements were obtained during the study (three pairs for each of the 33 participants). The device produced 73, 93, and 98 measurements within 5, 10, and 15 mmHg for systolic blood pressure (SBP) and 79, 93, and 96 for diastolic blood pressure (DBP), respectively. The mean standard deviation device-observer difference was 1.4 ± 5.2 mmHg for SBP and 0.02±5.8 mmHg for DBP. The number of participants with two or three of the device-observer differences within 5 mmHg was 24 for SBP and 30 for DBP, whereas there was no participant with none of the device-observer differences within 5 mmHg. According to the results of the validation study based on the ESH-IP revision 2010, the Medipro MediCare 100f can be recommended for self-measurement in an adult population.

Adherence to European Association of Urology Guidelines on Prophylactic Antibiotics: An Important Step in Antimicrobial Stewardship.

PubMed

Cai, Tommaso; Verze, Paolo; Brugnolli, Anna; Tiscione, Daniele; Luciani, Lorenzo Giuseppe; Eccher, Cristina; Lanzafame, Paolo; Malossini, Gianni; Wagenlehner, Florian M E; Mirone, Vincenzo; Bjerklund Johansen, Truls E; Pickard, Robert; Bartoletti, Riccardo

2016-02-01

The evolution of resistant pathogens is a worldwide health crisis and adherence to European Association of Urology (EAU) guidelines on antibiotic prophylaxis may be an important way to improve antibiotic stewardship and reduce patient harm and costs. To evaluate the prevalence of antibiotic-resistant bacterial strains and health care costs during a period of adherence to EAU guidelines in a tertiary referral urologic institution. A protocol for adherence to EAU guidelines for antibiotic prophylaxis for all urologic procedures was introduced in January 2011. Data for 3529 urologic procedures performed between January 2011 and December 2013 after protocol introduction were compared with data for 2619 procedures performed between January 2008 and December 2010 before protocol implementation. The prevalence of bacterial resistance and health care costs were compared between the two periods. The outcome measures were the proportion of resistant uropathogens and costs related to antibiotic consumption and symptomatic postoperative infection. We used χ2 and Fisher's exact tests to test the significance of differences. The proportion of patients with symptomatic postoperative infection did not differ (180/3529 [5.1%] vs. 117/2619 [4.5%]; p=0.27). A total of 342 isolates from all patients with symptomatic postoperative infections were analysed. The rate of resistance of Escherichia coli to piperacillin/tazobactam (9.1% vs. 5.4%; p=0.03), gentamicin (18.3% vs. 11.2%; p=0.02), and ciprofloxacin (32.3% vs. 19.1%; p=0.03) decreased significantly after protocol introduction. The defined daily dose (DDD) use of ciprofloxacin fell from 4.2 to 0.2 DDD per 100 patient-days after implementation (p<0.001). Antibiotic drug costs (€76,980 vs. €36,700) and costs related to postoperative infections (€45,870 vs. €29,560) decreased following introduction of the protocol (p<0.001). Adherence to EAU guidelines on antibiotic prophylaxis reduced antibiotic usage without increasing post-operative infection rate and lowered the prevalence of resistant uropathogens. We analysed the impact of adherence to European Association of Urology guidelines on antibiotic prophylaxis for all surgical urologic procedures on the prevalence of infections and resistant bacterial strains and on costs. We found that adherence to the guidelines reduced the rate of bacterial resistance, in particular against piperacillin/tazobactam, gentamicin, and ciprofloxacin, and reduced costs without increasing the risk of postoperative infection after urologic procedures. We recommend adherence to the guidelines as an important part of antibiotic stewardship programmes. Copyright © 2015 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Hospital implementation of resuscitation guidelines and review of CPR training programmes: a nationwide study.

PubMed

Schmidt, Anders S; Lauridsen, Kasper G; Adelborg, Kasper; Løfgren, Bo

2016-06-01

This study aimed to investigate cardiopulmonary resuscitation (CPR) guideline implementation and CPR training in hospitals. This nationwide study included mandatory resuscitation protocols from each Danish hospital. Protocols were systematically reviewed for adherence to the European Resuscitation Council (ERC) 2010 guidelines and CPR training in each hospital. Data were included from 45 of 47 hospitals. Adherence to the ERC basic life support (BLS) algorithm was 49%, whereas 63 and 58% of hospitals adhered to the recommended chest compression depth and rate. Adherence to the ERC advanced life support (ALS) algorithm was 81%. Hospital BLS course duration was [median (interquartile range)] 2.3 (1.5-2.5) h, whereas ALS course duration was 4.0 (2.5-8.0) h. Implementation of ERC 2010 guidelines on BLS is limited in Danish hospitals 2 years after guideline publication, whereas the majority of hospitals adhere to the ALS algorithm. CPR training differs among hospitals.

EMPReSS: European mouse phenotyping resource for standardized screens.

PubMed

Green, Eain C J; Gkoutos, Georgios V; Lad, Heena V; Blake, Andrew; Weekes, Joseph; Hancock, John M

2005-06-15

Standardized phenotyping protocols are essential for the characterization of phenotypes so that results are comparable between different laboratories and phenotypic data can be related to ontological descriptions in an automated manner. We describe a web-based resource for the visualization, searching and downloading of standard operating procedures and other documents, the European Mouse Phenotyping Resource for Standardized Screens-EMPReSS. Direct access: http://www.empress.har.mrc.ac.uk e.green@har.mrc.ac.uk.

Detection of Cryptosporidium and Giardia in clinical laboratories in Europe--a comparative study.

PubMed

Manser, M; Granlund, M; Edwards, H; Saez, A; Petersen, E; Evengard, B; Chiodini, P

2014-01-01

To determine the routine diagnostic methods used and compare the performance in detection of oocysts of Cryptosporidium species and cysts of Giardia intestinalis in faecal samples by European specialist parasitology laboratories and European clinical laboratories. Two sets of seven formalin-preserved faecal samples, one containing cysts of Giardia intestinalis and the other, containing oocysts of Cryptosporidium, were sent to 18 laboratories. Participants were asked to examine the specimens using their routine protocol for detecting these parasites and state the method(s) used. Eighteen laboratories answered the questionnaire. For detection of Giardia, 16 of them used sedimentation/concentration followed by light microscopy. Using this technique the lower limit of detection of Giardia was 17.2 cysts/mL of faeces in the best performing laboratories. Only three of 16 laboratories used fluorescent-conjugated antibody-based microscopy. For detection of Cryptosporidium acid-fast staining was used by 14 of the 17 laboratories that examined the samples. With this technique the lower limit of detection was 976 oocysts/mL of faeces. Fluorescent-conjugated antibody-based microscopy was used by only five of the 17 laboratories. There was variation in the lower limit of detection of cysts of Giardia and oocysts of Cryptosporidium between laboratories using the same basic microscopic methods. Fluorescent-conjugated antibody-based microscopy was not superior to light microscopy under the conditions of this study. There is a need for a larger-scale multi-site comparison of the methods used for the diagnosis of these parasites and the development of a Europe-wide laboratory protocol based upon its findings. © 2013 The Authors Clinical Microbiology and Infection © 2013 European Society of Clinical Microbiology and Infectious Diseases.

Patient-centred screening for primary immunodeficiency, a multi-stage diagnostic protocol designed for non-immunologists: 2011 update

PubMed Central

de Vries, E

2012-01-01

Members of the European Society for Immunodeficiencies (ESID) and other colleagues have updated the multi-stage expert-opinion-based diagnostic protocol for non-immunologists incorporating newly defined primary immunodeficiency diseases (PIDs). The protocol presented here aims to increase the awareness of PIDs among doctors working in different fields. Prompt identification of PID is important for prognosis, but this may not be an easy task. The protocol therefore starts from the clinical presentation of the patient. Because PIDs may present at all ages, this protocol is aimed at both adult and paediatric physicians. The multi-stage design allows cost-effective screening for PID of the large number of potential cases in the early phases, with more expensive tests reserved for definitive classification in collaboration with a specialist in the field of immunodeficiency at a later stage. PMID:22132890

The syntheses of 1-(2-thienyl)-2-(methylamino) propane (methiopropamine) and its 3-thienyl isomer for use as reference standards.

PubMed

Angelov, D; O'Brien, J; Kavanagh, P

2013-03-01

1-(2-Thienyl)-2-(methylamino)propane (methiopropamine, MPA), the thiophene analogue of methamphetamine, has recently appeared on a number of websites offering 'legal highs' for sale and has also been reported as a new psychoactive substance by the European Monitoring Centre for Drugs and Drugs Addiction (EMCDDA) Early Warning System. The drug is currently not controlled in the European Union (EU) but it would be expected that forensic laboratories will encounter it during routine analysis. As no reference standard was available, we have established a three-step protocol for its synthesis. We have also synthesized its 3-thienyl isomer and have established that this is separable from methiopropamine by gas chromatography using one of our routine protocols. The synthetic methodology presented here could be readily extended to the syntheses of analogous compounds. Copyright © 2011 John Wiley & Sons, Ltd.

Application of the European quality indicators for psychosocial dementia care in long-term care facilities in the Asia-Pacific region: a pilot study.

PubMed

Jeon, Yun-Hee; Chien, Wai Tong; Ha, Ju-Young; Ibrahim, Rahimah; Kirley, Belinda; Tan, Lay Ling; Thaipisuttikul, Papan; Vasse, Emmelyne; Vernooij-Dassen, Myrra; Wang, Huali; Youn, Jong-Chul; Brodaty, Henry

2017-07-17

An Asia-Pacific regional collaboration group conducted its first multi-country research project to determine whether or not European quality indicators (QIs) for psychosocial care in dementia could be implemented as a valid tool in residential aged care across seven Asia-Pacific sites (Australia, Hong Kong Special Administrative Region, Mainland China, Malaysia, Singapore, South Korea, and Thailand). Following the European QI protocol, auditing and data extraction of medical records of consenting residents with dementia were conducted by trained auditors with relevant health care backgrounds. Detailed field notes by the auditors were also obtained to describe the characteristics of the participating care facilities, as well as key issues and challenges encountered, for each of the 12 QIs. Sixteen residential care facilities in the seven Asia-Pacific sites participated in this study. Data from 275 residents' records revealed each of the 12 Qis' endorsement varied widely within and between the study sites (0%-100%). Quality of the medical records, family and cultural differences, definitions and scoring of certain indicators, and time-consuming nature of the QI administration were main concerns for implementation. Several items in the European QIs in the current format were deemed problematic when used to measure the quality of psychosocial care in the residential aged care settings in participating Asia-Pacific countries. We propose refinements of the European QIs for the Asian-Pacific context, taking into account multiple factors identified in this study. Our findings provide crucial insights for future research and implementation of psychosocial dementia care QIs in this region.

Evaluation of 5-year-old children with complete cleft lip and palate: Multicenter study. Part 1: Lip and nose aesthetic results.

PubMed

Dissaux, Caroline; Bodin, Frédéric; Grollemund, Bruno; Picard, Arnaud; Vazquez, Marie-Paule; Morand, Béatrice; James, Isabelle; Kauffmann, Isabelle; Bruant-Rodier, Catherine

2015-12-01

Cleft surgery is marked by all the controversies and the multiplication of protocols, as it has been shown by the Eurocleft study. The objective of this pilot study is to start a comparison and analyzing procedure between primary surgical protocols in French centers. Four French centers with different primary surgical protocols for cleft lip and palate repair, have accepted to be involved in this retrospective study. In each center, 20 consecutive patients with complete cleft lip and palate (10 UCLP and 10 BCLP per center), non syndromic, have been evaluated at a mean age of 5 [4,6]. In this first part, the aesthetic results of nose and lip repair were assessed based on the scale established by Mortier et al. (1997). Considering nose outcome, primary cleft repair surgery including a nasal dissection gives a statistically significant benefit in terms of septum deviation. Considering lip result, muscular dehiscence rate is significantly higher in BCLP patients with a two-stage lip closure. The centers using Millard one-stage lip closure do not have uniform results. For UCLP patients, the quality of scar is not statistically different between Skoog and Millard techniques. Primary results based on a simple, reproducible evaluation protocol. Extension to other centers required. Therapeutic study. Level III/retrospective multicenter comparative study. Copyright © 2015 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

Enhanced just-in-time plus protocol for optical burst switching networks

NASA Astrophysics Data System (ADS)

Rodrigues, Joel J. P. C.; Gregório, José M. B.; Vasilakos, Athanasios V.

2010-07-01

We propose a new one-way resource reservation protocol for optical burst switching (OBS) networks, called Enhanced Just-in-Time Plus (E-JIT+). The protocol is described in detail, and its formal specification is presented, following an extended finite state machine approach. The performance evaluation of E-JIT+ is analyzed in comparison with other proposed OBS protocols (JIT+ and E-JIT) for the following network topologies: rings; degree-two, degree-three, and degree-four chordal rings; mesh-torus; NSFNET; ARPANET; FCCN-NET; and the European Optical Network. We evaluate and compare the performance of the different protocols in terms of burst loss probability, taking into account the most important OBS network parameters. It was shown that E-JIT+ performs better than available one-way resource reservation protocols for all the evaluated network topologies. Moreover, the scalability of E-JIT+ was observed, and when the network traffic increases, the burst loss probability also increases, leading to a worse network performance.

Variation in population levels of physical activity in European adults according to cross-European studies: a systematic literature review within DEDIPAC.

PubMed

Loyen, Anne; Van Hecke, Linde; Verloigne, Maïté; Hendriksen, Ingrid; Lakerveld, Jeroen; Steene-Johannessen, Jostein; Vuillemin, Anne; Koster, Annemarie; Donnelly, Alan; Ekelund, Ulf; Deforche, Benedicte; De Bourdeaudhuij, Ilse; Brug, Johannes; van der Ploeg, Hidde P

2016-06-28

Physical inactivity is a well-known public health risk that should be monitored at the population level. Physical activity levels are often surveyed across Europe. This systematic literature review aims to provide an overview of all existing cross-European studies that assess physical activity in European adults, describe the variation in population levels according to these studies, and discuss the impact of the assessment methods. Six literature databases (PubMed, EMBASE, CINAHL, PsycINFO, SportDiscus and OpenGrey) were searched, supplemented with backward- and forward tracking and searching authors' and experts' literature databases. Articles were included if they reported on observational studies measuring total physical activity and/or physical activity in leisure time in the general population in two or more European countries. Each record was reviewed, extracted and assessed by two independent researchers and disagreements were resolved by a third researcher. The review protocol of this review is registered in the PROSPERO database under registration number CRD42014010334. Of the 9,756 unique identified articles, twenty-five were included in this review, reporting on sixteen different studies, including 2 to 35 countries and 321 to 274,740 participants. All but two of the studies used questionnaires to assess physical activity, with the majority of studies using the IPAQ-short questionnaire. The remaining studies used accelerometers. The percentage of participants who either were or were not meeting the physical activity recommendations was the most commonly reported outcome variable, with the percentage of participants meeting the recommendations ranging from 7% to 96% across studies and countries. The included studies showed substantial variation in the assessment methods, reported outcome variables and, consequently, the presented physical activity levels. Because of this, absolute population levels of physical activity in European adults are currently unknown. However, when ranking countries, Ireland, Italy, Malta, Portugal, and Spain generally appear to be among the less active countries. Objective data of adults across Europe is currently limited. These findings highlight the need for standardisation of the measurement methods, as well as cross-European monitoring of physical activity levels.

Water intake and beverage consumption of pre-schoolers from six European countries and associations with socio-economic status: the ToyBox-study.

PubMed

Pinket, An-Sofie; De Craemer, Marieke; Maes, Lea; De Bourdeaudhuij, Ilse; Cardon, Greet; Androutsos, Odysseas; Koletzko, Berthold; Moreno, Luis; Socha, Piotr; Iotova, Violeta; Manios, Yannis; Van Lippevelde, Wendy

2016-09-01

To study the quantity and quality of water intake from beverages among pre-schoolers and investigate associations with gender and socio-economic status (SES). Kindergarten-based cross-sectional survey within the large-scale European ToyBox-study. A standardized protocol was used and parents/caregivers filled in sociodemographic data and a semi-quantitative FFQ. Kindergartens in six European countries (Belgium, Bulgaria, Germany, Greece, Poland and Spain). European pre-schoolers (aged 3·5-5·5 years) and their parents/caregivers (n 7051). Mean water intake was 1051 ml/d; plain water, 547 ml/d; plain milk, 241 ml/d; other fruit juice, 104 ml/d; pure fruit juice, 59 ml/d; soft drinks, 55 ml/d; tea, 45 ml/d; sugared and chocolate milk, 37 ml/d; smoothies, 15 ml/d; and light soft drinks, 6 ml/d. Boys had a higher water intake than girls due to a higher consumption of plain water, but more importantly to the consumption of beverages of less quality. Lower-SES pre-schoolers scored better on quantity than high-SES pre-schoolers, but as a consequence of consumption of sugared beverages. Nevertheless, the associations differed by country. The water intake from beverages did not meet the European Food Safety Authority standard of 1280 ml/d; especially in Western European countries water intake from beverages was low. The most important water sources were plain water, milk and fruit juices. Interventions aiming at a proper and sufficient water intake should focus on both quantity and quality. Messages about water and water sources should be clear for everyone and interventions should be sufficiently tailored.

Performance assessment of a glucose control protocol in septic patients with an automated intermittent plasma glucose monitoring device.

PubMed

Umbrello, M; Salice, V; Spanu, P; Formenti, P; Barassi, A; Melzi d'Eril, G V; Iapichino, G

2014-10-01

The optimal level and modality of glucose control in critically ill patients is still debated. A protocolized approach and the use of nearly-continuous technologies are recommended to manage hyperglycemia, hypoglycemia and glycemic variability. We recently proposed a pato-physiology-based glucose control protocol which takes into account patient glucose/carbohydrate intake and insulin resistance. Aim of the present investigation was to assess the performance of our protocol with an automated intermittent plasma glucose monitoring device (OptiScanner™ 5000). OptiScanner™ was used in 6 septic patients, providing glucose measurement every 15' from a side-port of an indwelling central venous catheter. Target level of glucose was 80-150 mg/dL. Insulin infusion and kcal with nutritional support were also recorded. 6 septic patients were studied for 319 h (1277 measurements); 58 [45-65] hours for each patient (measurements/patient: 231 [172-265]). Blood glucose was at target for 93 [90-98]% of study time. Mean plasma glucose was 126 ± 11 mg/dL. Only 3 hypoglycemic episodes (78, 78, 69 mg/dL) were recorded. Glucose variability was limited: plasma glucose coefficient of variation was 11.7 ± 4.0% and plasma glucose standard deviation was 14.3 ± 5.5 mg/dL. The local glucose control protocol achieved satisfactory glucose control in septic patients along with a high degree of safeness. Automated intermittent plasma glucose monitoring seemed useful to assess the performance of the protocol. Copyright © 2013 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

Does groundwater protection in Europe require new EU-wide environmental quality standards?

PubMed

Balderacchi, Matteo; Filippini, Maria; Gemitzi, Alexandra; Klöve, Björn; Petitta, Marco; Trevisan, Marco; Wachniew, Przemysław; Witczak, Stanisław; Gargini, Alessandro

2014-01-01

The European Groundwater Directive could be improved by limiting the scopes of the Annexes I and II to the manmade and natural substances, respectively, and by defining a common monitoring protocol. The changes in the European landuse patterns, in particular the urban sprawl phenomena, obscure the distinction between the point and diffuse sources of contamination. In the future more importance will be given to the household contamination. Moreover, the agricultural environment could be used for developing new conceptual models related to the pharmaceuticals.

A post-mortem survey on end-of-life decisions using a representative sample of death certificates in Flanders, Belgium: research protocol

PubMed Central

Chambaere, Kenneth; Bilsen, Johan; Cohen, Joachim; Pousset, Geert; Onwuteaka-Philipsen, Bregje; Mortier, Freddy; Deliens, Luc

2008-01-01

Background Reliable studies of the incidence and characteristics of medical end-of-life decisions with a certain or possible life shortening effect (ELDs) are indispensable for an evidence-based medical and societal debate on this issue. This article presents the protocol drafted for the 2007 ELD Study in Flanders, Belgium, and outlines how the main aims and challenges of the study (i.e. making reliable incidence estimates of end-of-life decisions, even rare ones, and describing their characteristics; allowing comparability with past ELD studies; guaranteeing strict anonymity given the sensitive nature of the research topic; and attaining a sufficient response rate) are addressed in a post-mortem survey using a representative sample of death certificates. Study design Reliable incidence estimates are achievable by using large at random samples of death certificates of deceased persons in Flanders (aged one year or older). This entails the cooperation of the appropriate administrative authorities. To further ensure the reliability of the estimates and descriptions, especially of less prevalent end-of-life decisions (e.g. euthanasia), a stratified sample is drawn. A questionnaire is sent out to the certifying physician of each death sampled. The questionnaire, tested thoroughly and avoiding emotionally charged terms is based largely on questions that have been validated in previous national and European ELD studies. Anonymity of both patient and physician is guaranteed through a rigorous procedure, involving a lawyer as intermediary between responding physicians and researchers. To increase response we follow the Total Design Method (TDM) with a maximum of three follow-up mailings. Also, a non-response survey is conducted to gain insight into the reasons for lack of response. Discussion The protocol of the 2007 ELD Study in Flanders, Belgium, is appropriate for achieving the objectives of the study; as past studies in Belgium, the Netherlands, and other European countries have shown, strictly anonymous and thorough surveys among physicians using a large, stratified, and representative death certificate sample are most suitable in nationwide studies of incidence and characteristics of end-of-life decisions. There are however also some limitations to the study design. PMID:18752659

Validation of the iHealth BP5 wireless upper arm blood pressure monitor for self-measurement according to the European Society of Hypertension International Protocol revision 2010.

PubMed

Shang, Fujun; Zhu, Yizheng; Zhu, Zhenlai; Liu, Lei; Wan, Yi

2013-10-01

The aim of this study was to validate the iHealth BP5 wireless upper arm blood pressure (BP) monitor according to the European Society of Hypertension International Protocol (ESH-IP) revision 2010. The ESH-IP revision 2010 for validation of BP measuring devices in adults was followed precisely. A total of 99 pairs of test device and reference BP measurements (three pairs for each of the 33 participants) were obtained in the study. The device produced 71, 89, and 97 measurements within 5, 10, and 15 mmHg for systolic blood pressure (SBP) and 73, 90, and 99 mmHg for diastolic blood pressure (DBP), respectively. The mean ± SD device-observer difference was -1.21 ± 5.87 mmHg for SBP and -1.04 ± 5.28 mmHg for DBP. The number of participants with two or three device-observer differences within 5 mmHg was 25 for SBP and 28 for DBP. In addition, three participants had no device-observer difference within 5 mmHg for SBP and none of the participants had the same for DBP. According to the validation results on the basis of the ESH-IP revision 2010, the iHealth BP5 wireless upper arm BP monitor can be recommended for self/home measurement in an adult population.

Multi-laboratory validation study of multilocus variable-number tandem repeat analysis (MLVA) for Salmonella enterica serovar Enteritidis, 2015.

PubMed

Peters, Tansy; Bertrand, Sophie; Björkman, Jonas T; Brandal, Lin T; Brown, Derek J; Erdõsi, Tímea; Heck, Max; Ibrahem, Salha; Johansson, Karin; Kornschober, Christian; Kotila, Saara M; Le Hello, Simon; Lienemann, Taru; Mattheus, Wesley; Nielsen, Eva Møller; Ragimbeau, Catherine; Rumore, Jillian; Sabol, Ashley; Torpdahl, Mia; Trees, Eija; Tuohy, Alma; de Pinna, Elizabeth

2017-03-02

Multilocus variable-number tandem repeat analysis (MLVA) is a rapid and reproducible typing method that is an important tool for investigation, as well as detection, of national and multinational outbreaks of a range of food-borne pathogens. Salmonella enterica serovar Enteritidis is the most common Salmonella serovar associated with human salmonellosis in the European Union/European Economic Area and North America. Fourteen laboratories from 13 countries in Europe and North America participated in a validation study for MLVA of S. Enteritidis targeting five loci. Following normalisation of fragment sizes using a set of reference strains, a blinded set of 24 strains with known allele sizes was analysed by each participant. The S. Enteritidis 5-loci MLVA protocol was shown to produce internationally comparable results as more than 90% of the participants reported less than 5% discrepant MLVA profiles. All 14 participating laboratories performed well, even those where experience with this typing method was limited. The raw fragment length data were consistent throughout, and the inter-laboratory validation helped to standardise the conversion of raw data to repeat numbers with at least two countries updating their internal procedures. However, differences in assigned MLVA profiles remain between well-established protocols and should be taken into account when exchanging data. This article is copyright of The Authors, 2017.

Standardised surveillance of Clostridium difficile infection in European acute care hospitals: a pilot study, 2013.

PubMed

van Dorp, Sofie M; Kinross, Pete; Gastmeier, Petra; Behnke, Michael; Kola, Axel; Delmée, Michel; Pavelkovich, Anastasia; Mentula, Silja; Barbut, Frédéric; Hajdu, Agnes; Ingebretsen, André; Pituch, Hanna; Macovei, Ioana S; Jovanović, Milica; Wiuff, Camilla; Schmid, Daniela; Olsen, Katharina Ep; Wilcox, Mark H; Suetens, Carl; Kuijper, Ed J

2016-07-21

Clostridium difficile infection (CDI) remains poorly controlled in many European countries, of which several have not yet implemented national CDI surveillance. In 2013, experts from the European CDI Surveillance Network project and from the European Centre for Disease Prevention and Control developed a protocol with three options of CDI surveillance for acute care hospitals: a 'minimal' option (aggregated hospital data), a 'light' option (including patient data for CDI cases) and an 'enhanced' option (including microbiological data on the first 10 CDI episodes per hospital). A total of 37 hospitals in 14 European countries tested these options for a three-month period (between 13 May and 1 November 2013). All 37 hospitals successfully completed the minimal surveillance option (for 1,152 patients). Clinical data were submitted for 94% (1,078/1,152) of the patients in the light option; information on CDI origin and outcome was complete for 94% (1,016/1,078) and 98% (294/300) of the patients in the light and enhanced options, respectively. The workload of the options was 1.1, 2.0 and 3.0 person-days per 10,000 hospital discharges, respectively. Enhanced surveillance was tested and was successful in 32 of the hospitals, showing that C. difficile PCR ribotype 027 was predominant (30% (79/267)). This study showed that standardised multicountry surveillance, with the option of integrating clinical and molecular data, is a feasible strategy for monitoring CDI in Europe. This article is copyright of The Authors, 2016.

COBA-Cohort: a prospective cohort of HIV-negative men who have sex with men, attending community-based HIV testing services in five European countries (a study protocol).

PubMed

Lorente, Nicolas; Fernàndez-López, Laura; Fuertes, Ricardo; Rojas Castro, Daniela; Pichon, François; Cigan, Bojan; Chanos, Sophocles; Meireles, Paula; Lucas, Raquel; Morel, Stéphane; Slaaen Kaye, Per; Agustí, Cristina; Klavs, Irena; Platteau, Tom; Casabona, Jordi

2016-07-13

Community-based voluntary counselling and testing (CBVCT) services for men who have sex with men (MSM) can reach those most-at-risk and provide an environment for gay men that is likely to be non-stigmatising. Longitudinal data on the behaviour of HIV-negative MSM are scarce in Europe. The aim of this protocol, developed during the Euro HIV Early Diagnosis And Treatment (EDAT) project, is to implement a multicentre community-based cohort of HIV-negative MSM attending 15 CBVCT services in 5 European countries. (1) To describe the patterns of CBVCT use, (2) to estimate HIV incidence, and to identify determinants of (3) HIV seroconversion and (4) HIV and/or sexually transmitted infection (STI) test-seeking behaviour. All MSM aged 18 years or over and who had a negative HIV test result are invited to participate in the COmmunity-BAsed Cohort (COBA-Cohort). Study enrolment started in February 2015, and is due to continue for at least 12 months at each study site. Follow-up frequency depends on the testing recommendations in each country (at least 1 test per year). Sociodemographic data are collected at baseline; baseline and follow-up questionnaires both gather data on attitudes and perceptions, discrimination, HIV/STI testing history, sexual behaviour, condom use, and pre- and post-exposure prophylaxis. Descriptive, exploratory and multivariate analyses will be performed to address the main research objectives of this study, using appropriate statistical tests and models. These analyses will be performed on the whole cohort data and stratified by study site or country. The study was approved by the Public Health authorities of each country where the study is being implemented. Findings from the COBA-Cohort study will be summarised in a report to the European Commission, and in leaflets to be distributed to study participants. Articles and conference abstracts will be submitted to peer-reviewed journals and conferences. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Toxicology Study No. S.0024589d 15, Human Cell Line Activation Test of the Novel Energetic, 3,4 -Dinitropyrazole (DNP)

DTIC Science & Technology

2016-04-01

potential. The h-CLAT is one of many non- animal skin sensitizing tests , and it comprises part of an integrated testing strategy with two other in vitro...Protocol No. 158. 2015: European Union Reference Laboratory for Alternatives to Animal Testing [18, 19]. Toxicology Study No. S.0024589d-15, April...Alternatives to Animal Testing [18, 19]. If the EC200 or EC150 fell below the lowest dose, the values were extrapolated by the following equations

Sedation practice in Nordic and non-Nordic ICUs: a European survey.

PubMed

Egerod, Ingrid; Albarran, John W; Ring, Mette; Blackwood, Bronagh

2013-07-01

A trend towards lighter sedation has been evident in many intensive care units (ICUs). The aims of the survey were to describe sedation practice in European ICUs and to compare sedation practice in Nordic and non-Nordic countries. A cross-sectional survey of ICU nurses attending the fourth European federation of Critical Care Nursing associations (EfCCNa) in Denmark, 2011. Data included use of protocols; sedation, pain and delirium assessment tools; collaborative decision-making; sedation and analgesic medications; and educational preparation related to sedation. Response rate was 42% (n = 291) from 22 countries where 53% (n = 148) used sedation protocols. Nordic nurses reported greater use of sedation (91% versus 67%, p < 0·01) and pain (91% versus 69%, p < 0·01) assessment tools than non-Nordic nurses. Decision-making on sedation was more inter-professionally collaborative in Nordic ICUs (83% versus 61%, p < 0·01), units were smaller (10 versus 15 beds, p < 0·01) and nurse-patient ratio was higher (1:1, 75% versus 26%, p < 0·01). Nordic nurses reported greater consistency in maintaining circadian rhythm (66% versus 49%, p < 0·01), less use of physical restraints (14% versus 36%, p < 0·01), less use of neuromuscular blocking agents (3% versus 16%, p < 0·01), and received more sedation education (92% versus 76%, p < 0·01). Delirium assessment was not performed systematically in most settings. Organizational and contextual factors, such as ICU size, staffing ratio and inter-professional collaboration, are contributing factors to sedation management in European ICUs. The Nordic context might be more germane to the goal of lighter sedation and better pain management. Our study raises awareness of current sedation practice, paving the way towards optimized ICU sedation management. © 2013 The Authors. Nursing in Critical Care © 2013 British Association of Critical Care Nurses.

Approaches for controlling illicit tobacco trade--nine countries and the European Union.

PubMed

Ross, Hana; Husain, Muhammad Jami; Kostova, Deliana; Xu, Xin; Edwards, Sarah M; Chaloupka, Frank J; Ahluwalia, Indu B

2015-05-29

An estimated 11.6% of the world cigarette market is illicit, representing more than 650 billion cigarettes a year and $40.5 billion in lost revenue. Illicit tobacco trade refers to any practice related to distributing, selling, or buying tobacco products that is prohibited by law, including tax evasion (sale of tobacco products without payment of applicable taxes), counterfeiting, disguising the origin of products, and smuggling. Illicit trade undermines tobacco prevention and control initiatives by increasing the accessibility and affordability of tobacco products, and reduces government tax revenue streams. The World Health Organization (WHO) Protocol to Eliminate Illicit Trade in Tobacco Products, signed by 54 countries, provides tools for addressing illicit trade through a package of regulatory and governing principles. As of May 2015, only eight countries had ratified or acceded to the illicit trade protocol, with an additional 32 needed for it to become international law (i.e., legally binding). Data from multiple international sources were analyzed to evaluate the 10 most commonly used approaches for addressing illicit trade and to summarize differences in implementation across select countries and the European Union (EU). Although the WHO illicit trade protocol defines shared global standards for addressing illicit trade, countries are guided by their own legal and enforcement frameworks, leading to a diversity of approaches employed across countries. Continued adoption of the methods outlined in the WHO illicit trade protocol might improve the global capacity to reduce illicit trade in tobacco products.

Validation of the Artsana CSI 610 automated blood pressure monitor in adults according to the International Protocol of the European Society of Hypertension.

PubMed

Pini, Claudio; Pastori, Marco; Baccheschi, Jordan; Omboni, Stefano; Parati, Gianfranco

2007-06-01

There is evidence that blood pressure measurement outside the doctor's office can provide valuable information for the diagnostic evaluation of hypertensive patients and for monitoring their response to treatment. Home blood pressure monitoring devices have a major role in this setting, provided that their accuracy in measuring blood pressure is demonstrated by validation studies. This study aimed at verifying whether the automatic electronic oscillometric blood pressure measuring device Artsana CSI 610 complied with the standard of accuracy indicated by the ESH International Protocol. Sequential measurements of systolic and diastolic blood pressure were obtained in 33 participants using the mercury sphygmomanometer (two observers) and the test device (one supervisor). A standard adult cuff was always employed during the study. According to the ESH validation protocol, 99 couples of test device and reference blood pressure measurements were obtained during the two phases of the study (three pairs for each of the 33 participants). The Artsana CSI 610 device successfully passed phase 1 of study validation with the number of absolute differences between test and reference device never <35 within 5 mmHg and never <40 within 10 and 15 mmHg. The test device also passed phase 2 of the validation study with a mean (+/-SD) device-observer difference of -1.4+/-4.8 mmHg for systolic and -0.9+/-3.5 mmHg for diastolic blood pressure. According to the results of the validation study on the basis of the ESH International Protocol, the Artsana CSI 610 can be recommended for clinical use in adults.

A randomized controlled trial comparing two techniques for unilateral cleft lip and palate: Growth and speech outcomes during mixed dentition.

PubMed

Ganesh, Praveen; Murthy, Jyotsna; Ulaghanathan, Navitha; Savitha, V H

2015-07-01

To study the growth and speech outcomes in children who were operated on for unilateral cleft lip and palate (UCLP) by a single surgeon using two different treatment protocols. A total of 200 consecutive patients with nonsyndromic UCLP were randomly allocated to two different treatment protocols. Of the 200 patients, 179 completed the protocol. However, only 85 patients presented for follow-up during the mixed dentition period (7-10 years of age). The following treatment protocol was followed. Protocol 1 consisted of the vomer flap (VF), whereby patients underwent primary lip nose repair and vomer flap for hard palate single-layer closure, followed by soft palate repair 6 months later; Protocol 2 consisted of the two-flap technique (TF), whereby the cleft palate (CP) was repaired by two-flap technique after primary lip and nose repair. GOSLON Yardstick scores for dental arch relation, and speech outcomes based on universal reporting parameters, were noted. A total of 40 patients in the VF group and 45 in the TF group completed the treatment protocols. The GOSLON scores showed marginally better outcomes in the VF group compared to the TF group. Statistically significant differences were found only in two speech parameters, with better outcomes in the TF group. Our results showed marginally better growth outcome in the VF group compared to the TF group. However, the speech outcomes were better in the TF group. Copyright © 2015 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

A longitudinal, multi-level comparative study of quality and safety in European hospitals: the QUASER study protocol.

PubMed

Robert, Glenn B; Anderson, Janet E; Burnett, Susan J; Aase, Karina; Andersson-Gare, Boel; Bal, Roland; Calltorp, Johan; Nunes, Francisco; Weggelaar, Anne-Marie; Vincent, Charles A; Fulop, Naomi J

2011-10-26

although there is a wealth of information available about quality improvement tools and techniques in healthcare there is little understanding about overcoming the challenges of day-to-day implementation in complex organisations like hospitals. The 'Quality and Safety in Europe by Research' (QUASER) study will investigate how hospitals implement, spread and sustain quality improvement, including the difficulties they face and how they overcome them. The overall aim of the study is to explore relationships between the organisational and cultural characteristics of hospitals and how these impact on the quality of health care; the findings will be designed to help policy makers, payers and hospital managers understand the factors and processes that enable hospitals in Europe to achieve-and sustain-high quality services for their patients. in-depth multi-level (macro, meso and micro-system) analysis of healthcare quality policies and practices in 5 European countries, including longitudinal case studies in a purposive sample of 10 hospitals. The project design has three major features: • a working definition of quality comprising three components: clinical effectiveness, patient safety and patient experience • a conceptualisation of quality as a human, social, technical and organisational accomplishment • an emphasis on translational research that is evidence-based and seeks to provide strategic and practical guidance for hospital practitioners and health care policy makers in the European Union. Throughout the study we will adopt a mixed methods approach, including qualitative (in-depth, narrative-based, ethnographic case studies using interviews, and direct non-participant observation of organisational processes) and quantitative research (secondary analysis of safety and quality data, for example: adverse incident reporting; patient complaints and claims). the protocol is based on the premise that future research, policy and practice need to address the sociology of improvement in equal measure to the science and technique of improvement, or at least expand the discipline of improvement to include these critical organisational and cultural processes. We define the 'organisational and cultural characteristics associated with better quality of care' in a broad sense that encompasses all the features of a hospital that might be hypothesised to impact upon clinical effectiveness, patient safety and/or patient experience.

Protocol update and preliminary results of EACVI/HFA Cardiac Oncology Toxicity (COT) Registry of the European Society of Cardiology

PubMed Central

Galderisi, Maurizio; Donal, Erwan; Edvardsen, Thor; Popescu, Bogdan A.; Farmakis, Dimitrios; Filippatos, Gerasimos; Habib, Gilbert; Lestuzzi, Chiara; Santoro, Ciro; Moonen, Marie; Jerusalem, Guy; Andarala, Maryna; Anker, Stefan D.

2017-01-01

Abstract Aims European Association of Cardiovascular Imaging/Heart Failure Association Cardiac Oncology Toxicity Registry was launched in October 2014 as a European Society of Cardiology multicentre registry of breast cancer patients referred to imaging laboratories for routine surveillance, suspected, or confirmed anticancer drug‐related cardiotoxicity (ADRC). After a pilot phase (1 year recruitment and 1 year follow‐up), some changes have been made to the protocol (version 1.0) and electronic case report form. Methods and results Main changes of the version 2.0 concerned exclusion criteria, registry duration, and clarification of the population characteristics. Breast cancer radiotherapy has been removed as an exclusion criterion, which involves now only history of a pre‐chemotherapy left ventricular dysfunction. The period for long‐term registry recruitment has been reduced (December 2017), but the target study population was extended to 3000 patients. The characteristics of the population are now better defined: patients seen in an imaging lab, which will include patients undergoing chemotherapy with associated targeted therapy or no targeted therapy, at increased risk of ADRC. In total, 1294 breast cancer patients have been enrolled, and 783 case report forms locked from October 2014 to November 2016. Of these, 481 (61.4%) were seen at first evaluation and 302 (38.6%) while on oncologic treatment with anticancer drugs. Fifty‐two patients (17.2%) were not in targeted therapies, 191 (63.3%) were ongoing targeted therapy, and 59 (19.5%) had completed it. Twenty‐three (2.9%) patients had a suspected diagnosis and 35 (4.5%) a confirmed diagnosis of ADRC. Arterial hypertension was the most prevalent cardiovascular risk factor (29.2%) followed by diabetes (6.1%). Previous history of heart failure accounted for 0.5%, whereas previous cardiac disease was identified in 6.3% of population. Conclusion The changes of the original protocol of the COT Registry and first update allow a first glance to the panorama of cardiovascular characteristics of breast cancer patients enrolled. PMID:28772051

European Consensus Guidelines on the Management of Respiratory Distress Syndrome - 2016 Update.

PubMed

Sweet, David G; Carnielli, Virgilio; Greisen, Gorm; Hallman, Mikko; Ozek, Eren; Plavka, Richard; Saugstad, Ola Didrik; Simeoni, Umberto; Speer, Christian P; Vento, Máximo; Visser, Gerard H A; Halliday, Henry L

2017-01-01

Advances in the management of respiratory distress syndrome (RDS) ensure that clinicians must continue to revise current practice. We report the third update of the European Guidelines for the Management of RDS by a European panel of expert neonatologists including input from an expert perinatal obstetrician based on available literature up to the beginning of 2016. Optimizing the outcome for babies with RDS includes consideration of when to use antenatal steroids, and good obstetric practice includes methods of predicting the risk of preterm delivery and also consideration of whether transfer to a perinatal centre is necessary and safe. Methods for optimal delivery room management have become more evidence based, and protocols for lung protection, including initiation of continuous positive airway pressure and titration of oxygen, should be implemented from soon after birth. Surfactant replacement therapy is a crucial part of the management of RDS, and newer protocols for surfactant administration are aimed at avoiding exposure to mechanical ventilation, and there is more evidence of differences among various surfactants in clinical use. Newer methods of maintaining babies on non-invasive respiratory support have been developed and offer potential for greater comfort and less chronic lung disease. As technology for delivering mechanical ventilation improves, the risk of causing lung injury should decrease although minimizing the time spent on mechanical ventilation using caffeine and if necessary postnatal steroids are also important considerations. Protocols for optimizing the general care of infants with RDS are also essential with good temperature control, careful fluid and nutritional management, maintenance of perfusion and judicious use of antibiotics all being important determinants of best outcome. © 2016 S. Karger AG, Basel.

GMOMETHODS: the European Union database of reference methods for GMO analysis.

PubMed

Bonfini, Laura; Van den Bulcke, Marc H; Mazzara, Marco; Ben, Enrico; Patak, Alexandre

2012-01-01

In order to provide reliable and harmonized information on methods for GMO (genetically modified organism) analysis we have published a database called "GMOMETHODS" that supplies information on PCR assays validated according to the principles and requirements of ISO 5725 and/or the International Union of Pure and Applied Chemistry protocol. In addition, the database contains methods that have been verified by the European Union Reference Laboratory for Genetically Modified Food and Feed in the context of compliance with an European Union legislative act. The web application provides search capabilities to retrieve primers and probes sequence information on the available methods. It further supplies core data required by analytical labs to carry out GM tests and comprises information on the applied reference material and plasmid standards. The GMOMETHODS database currently contains 118 different PCR methods allowing identification of 51 single GM events and 18 taxon-specific genes in a sample. It also provides screening assays for detection of eight different genetic elements commonly used for the development of GMOs. The application is referred to by the Biosafety Clearing House, a global mechanism set up by the Cartagena Protocol on Biosafety to facilitate the exchange of information on Living Modified Organisms. The publication of the GMOMETHODS database can be considered an important step toward worldwide standardization and harmonization in GMO analysis.

Evaluation of the relationship between compliance with the follow-up and treatment protocol and health literacy in bladder tumor patients.

PubMed

Turkoglu, Ali Riza; Demirci, Hakan; Coban, Soner; Guzelsoy, Muhammet; Toprak, Erdem; Aydos, Mustafa Murat; Ture, Deniz Azkan; Ustundag, Yasemin

2018-03-07

To investigate the relationship between the compliance of bladder cancer patients with cystoscopic follow-up and the treatment protocol, and their health literacy. Patients who underwent transurethral resection surgery for bladder tumor were found to have non-muscular invasive bladder carcinoma on pathology examination and then underwent cystoscopic follow-up for 1 year or more were included in the study. Cystoscopic follow-up was recommended to the low- and high-risk groups in terms of progression and recurrence. The patients were evaluated with the Health Literacy Survey-European Union scale. The mean age of the patients was 67.13 ± 10.77 years. The treatment continuity rate was 80.50% (n = 33) in the adequate health literacy group (n = 41) and significantly higher than the 56.50% (n = 48) rate in the inadequate health literacy group (n = 85) (p = .008). The health literacy results revealed that the health promotion and general index score was higher in the group of patients under the age of 65. Adequate health literacy in bladder cancer patients is associated with better compliance with the treatment protocol. Young patients show better compliance with the follow-up protocol recommended by the physician. Increasing the follow-up protocol compliance of elderly patients with inadequate health literacy is necessary.

Retrospective analysis of 119 cases of pediatric acute promyelocytic leukemia: Comparisons of four treatment regimes

PubMed Central

LI, EN-QIN; XU, LING; ZHANG, ZHI-QUAN; XIAO, YAN; GUO, HAI-XIA; LUO, XUE-QUN; HU, QUN; LAI, DONG-BO; TU, LI-MING; JIN, RUN-MING

2012-01-01

Clinical trials have demonstrated that pediatric acute promyelocytic leukemia (APL) is highly curable. Small-scale studies have reported on the treatment of APL using one or two treatment regimes. Here, we report a multiple center-based study of 119 cases of pediatric APL treated with four regimes based on all-trans-retinoic acid (ATRA). We retrospectively analyzed the clinical characteristics, laboratorial test results and treatment outcome of the pediatric APL patients. Regime 1 used an in-house developed protocol, regime 2 was modified from the PETHEMA LPA99 protocol, regime 3 was modified from the European-APL93 protocol, and regime 4 used a protocol suggested by the British Committee for Standards in Haematology. The overall complete remission rates for the four regimes were 88.9, 87.5, 97.1 and 87.5%, respectively, which exhibited no statistical difference. However, more favorable results were observed for regimes 2 and 3 than regimes 1 and 4, in terms of the estimated 3.5-year disease-free survivals, relapse rates, drug toxicity (including hepatotoxicity, cardiac arrhythmia, and differentiation syndrome) and sepsis. In conclusion, the overall outcomes were more favorable after treatment with regimes 2 and 3 than with regimes 1 and 4, and this may have been due to the specific compositions of regimes 2 and 3. PMID:23060929

Distributional assumptions in food and feed commodities- development of fit-for-purpose sampling protocols.

PubMed

Paoletti, Claudia; Esbensen, Kim H

2015-01-01

Material heterogeneity influences the effectiveness of sampling procedures. Most sampling guidelines used for assessment of food and/or feed commodities are based on classical statistical distribution requirements, the normal, binomial, and Poisson distributions-and almost universally rely on the assumption of randomness. However, this is unrealistic. The scientific food and feed community recognizes a strong preponderance of non random distribution within commodity lots, which should be a more realistic prerequisite for definition of effective sampling protocols. Nevertheless, these heterogeneity issues are overlooked as the prime focus is often placed only on financial, time, equipment, and personnel constraints instead of mandating acquisition of documented representative samples under realistic heterogeneity conditions. This study shows how the principles promulgated in the Theory of Sampling (TOS) and practically tested over 60 years provide an effective framework for dealing with the complete set of adverse aspects of both compositional and distributional heterogeneity (material sampling errors), as well as with the errors incurred by the sampling process itself. The results of an empirical European Union study on genetically modified soybean heterogeneity, Kernel Lot Distribution Assessment are summarized, as they have a strong bearing on the issue of proper sampling protocol development. TOS principles apply universally in the food and feed realm and must therefore be considered the only basis for development of valid sampling protocols free from distributional constraints.

[Study protocol of a prevention of recurrent suicidal behaviour program based on case management (PSyMAC)].

PubMed

Sáiz, Pilar A; Rodríguez-Revuelta, Julia; González-Blanco, Leticia; Burón, Patricia; Al-Halabí, Susana; Garrido, Marlen; García-Alvarez, Leticia; García-Portilla, Paz; Bobes, Julio

2014-01-01

Prevention of suicidal behaviour is a public health priority in the European Union. A previous suicide attempt is the best risk predictor for future attempts, as well as completed suicides. The primary aim of this article is to describe a controlled study protocol designed for prevention of recurrent suicidal behaviour that proposes case management, and includes a psychoeducation program, as compared with the standard intervention (PSyMAC). Patients admitted from January 2011 to June 2013 to the emergency room of the Hospital Universitario Central de Asturias were evaluated using a protocol including sociodemographic, psychiatric, and psychosocial assessment. Patients were randomly assigned to either a group receiving continuous case management including participation in a psychoeducation program (experimental group), or a control group receiving standard care. The primary objective is to examine whether or not the period of time until recurrent suicidal behaviour in the experimental group is significantly different from that of the control group. PSyMAC proposes low cost and easily adaptable interventions to the usual clinical setting that can help to compensate the shortcoming of specific action protocols and suicidal behaviour prevention programs in our country. The evaluation of PSyMAC results will determine their real effectivity as a case-magament program to reduce suicidal risk. Copyright © 2013 SEP y SEPB. Published by Elsevier España. All rights reserved.

Hybrid cardiac imaging using PET/MRI: a joint position statement by the European Society of Cardiovascular Radiology (ESCR) and the European Association of Nuclear Medicine (EANM).

PubMed

Nensa, Felix; Bamberg, Fabian; Rischpler, Christoph; Menezes, Leon; Poeppel, Thorsten D; la Fougère, Christian; Beitzke, Dietrich; Rasul, Sazan; Loewe, Christian; Nikolaou, Konstantin; Bucerius, Jan; Kjaer, Andreas; Gutberlet, Matthias; Prakken, Niek H; Vliegenthart, Rozemarijn; Slart, Riemer H J A; Nekolla, Stephan G; Lassen, Martin L; Pichler, Bernd J; Schlosser, Thomas; Jacquier, Alexis; Quick, Harald H; Schäfers, Michael; Hacker, Marcus

2018-05-02

Positron emission tomography (PET) and magnetic resonance imaging (MRI) have both been used for decades in cardiovascular imaging. Since 2010, hybrid PET/MRI using sequential and integrated scanner platforms has been available, with hybrid cardiac PET/MR imaging protocols increasingly incorporated into clinical workflows. Given the range of complementary information provided by each method, the use of hybrid PET/MRI may be justified and beneficial in particular clinical settings for the evaluation of different disease entities. In the present joint position statement, we critically review the role and value of integrated PET/MRI in cardiovascular imaging, provide a technical overview of cardiac PET/MRI and practical advice related to the cardiac PET/MRI workflow, identify cardiovascular applications that can potentially benefit from hybrid PET/MRI, and describe the needs for future development and research. In order to encourage its wide dissemination, this article is freely accessible on the European Radiology and European Journal of Hybrid Imaging web sites. • Studies and case-reports indicate that PET/MRI is a feasible and robust technology. • Promising fields of application include a variety of cardiac conditions. • Larger studies are required to demonstrate its incremental and cost-effective value. • The translation of novel radiopharmaceuticals and MR-sequences will provide exciting new opportunities.

Interpretation of aged sorption studies for pesticides and their use in European Union regulatory leaching assessments.

PubMed

Beulke, Sabine; van Beinum, Wendy; Suddaby, Laura

2015-04-01

First-tier regulatory exposure assessments for pesticides assume that pesticide sorption is instantaneous and fully reversible. In European Union (EU) regulatory guidance, an increase in sorption over time ("aged sorption") can be considered at the higher tier to refine predicted environmental concentrations in groundwater. Research commissioned by the UK Chemicals Regulation Directorate (CRD), funded by the Department for Environment Food & Rural Affairs (Defra), formed the basis of a draft regulatory guidance document proposing 1) a protocol on how to measure aged sorption of parent compounds in laboratory studies, 2) procedures to fit kinetic models to the experimental data, 3) criteria to test the reliability of the parameters, and 4) procedures for use of the parameters in the groundwater exposure assessment. The draft guidance was revised after feedback from stakeholders and testing of the guidance was performed against real data sets by an independent consultancy. The Chemicals Regulation Directorate submitted the revised document to the European Food Safety Authority (EFSA) for scrutiny. This article gives an overview of the draft guidance and explains the reasoning behind the recommendations made. 2015 Crown Copyright; Published 2015 SETAC.

Curated eutherian third party data gene data sets.

PubMed

Premzl, Marko

2016-03-01

The free available eutherian genomic sequence data sets advanced scientific field of genomics. Of note, future revisions of gene data sets were expected, due to incompleteness of public eutherian genomic sequence assemblies and potential genomic sequence errors. The eutherian comparative genomic analysis protocol was proposed as guidance in protection against potential genomic sequence errors in public eutherian genomic sequences. The protocol was applicable in updates of 7 major eutherian gene data sets, including 812 complete coding sequences deposited in European Nucleotide Archive as curated third party data gene data sets.

Microplastics in seafood: Benchmark protocol for their extraction and characterization.

PubMed

Dehaut, Alexandre; Cassone, Anne-Laure; Frère, Laura; Hermabessiere, Ludovic; Himber, Charlotte; Rinnert, Emmanuel; Rivière, Gilles; Lambert, Christophe; Soudant, Philippe; Huvet, Arnaud; Duflos, Guillaume; Paul-Pont, Ika

2016-08-01

Pollution of the oceans by microplastics (<5 mm) represents a major environmental problem. To date, a limited number of studies have investigated the level of contamination of marine organisms collected in situ. For extraction and characterization of microplastics in biological samples, the crucial step is the identification of solvent(s) or chemical(s) that efficiently dissolve organic matter without degrading plastic polymers for their identification in a time and cost effective way. Most published papers, as well as OSPAR recommendations for the development of a common monitoring protocol for plastic particles in fish and shellfish at the European level, use protocols containing nitric acid to digest the biological tissues, despite reports of polyamide degradation with this chemical. In the present study, six existing approaches were tested and their effects were compared on up to 15 different plastic polymers, as well as their efficiency in digesting biological matrices. Plastic integrity was evaluated through microscopic inspection, weighing, pyrolysis coupled with gas chromatography and mass spectrometry, and Raman spectrometry before and after digestion. Tissues from mussels, crabs and fish were digested before being filtered on glass fibre filters. Digestion efficiency was evaluated through microscopical inspection of the filters and determination of the relative removal of organic matter content after digestion. Five out of the six tested protocols led to significant degradation of plastic particles and/or insufficient tissue digestion. The protocol using a KOH 10% solution and incubation at 60 °C during a 24 h period led to an efficient digestion of biological tissues with no significant degradation on all tested polymers, except for cellulose acetate. This protocol appeared to be the best compromise for extraction and later identification of microplastics in biological samples and should be implemented in further monitoring studies to ensure relevance and comparison of environmental and seafood product quality studies. Copyright © 2016 Elsevier Ltd. All rights reserved.

Policy Guidelines for Effective Inclusion and Reintegration of People with Chronic Diseases in the Workplace: National and European Perspectives.

PubMed

Vlachou, Anastasia; Stavroussi, Panayiota; Roka, Olga; Vasilou, Evdokia; Papadimitriou, Dimitra; Scaratti, Chiara; Kadyrbaeva, Asel; Fheodoroff, Klemens; Brecelj, Valentina; Svestkova, Olga; Tobiasz-Adamczyk, Beata; Finnvold, Jon Erik; Gruber, Sonja; Leonardi, Matilde

2018-03-11

The increasing prevalence of chronic diseases among the European working age population, as well as the implications for the individual and societal level, underline the need for policy guidelines targeting the effective inclusion of persons with chronic diseases in the workplace. The aim of the present paper was to explore the perspectives of European and National-level stakeholders on existing strategies for work re-integration of persons with chronic diseases, and to provide policy guidelines. A highly-structured interview protocol was distributed to 58 National level stakeholders (policy makers, professionals and employers) from seven European countries. Additionally, 20 European organizations concerned with health-related issues and employment completed an online survey. The findings reveal that employment-related challenges remain largely unaddressed. Both national and European stakeholders considered the existing legislative frameworks inadequate and appraised the co-ordination for the implementation of employment re-integration policies as ineffective. Policies targeting at work re-integration of persons with chronic diseases at European and national level should focus on consistent cooperation among all key stakeholders, awareness raising to staff and management, dissemination of effective strategies, developing research and evaluation standards and establishing monitoring systems on inclusive labour markets.

Implementing Infrastructures for Managing Learning Objects

ERIC Educational Resources Information Center

Klemke, Roland; Ternier, Stefaan; Kalz, Marco; Specht, Marcus

2010-01-01

Making learning objects available is critical to reuse learning resources. Making content transparently available and providing added value to different stakeholders is among the goals of the European Commission's eContentplus programme. This paper analyses standards and protocols relevant for making learning objects accessible in distributed data…

Secure Transaction Protocol for CEPS Compliant EPS in Limited Connectivity Environment

NASA Astrophysics Data System (ADS)

Devane, Satish; Phatak, Deepak

Common Electronic Purse Specification (CEPS) used by European countries, elaborately defines the transaction between customer’s CEP card and merchant’s point of sales (POS) terminal. However it merely defines the specification to transfer the transactions between the Merchant and Merchant Acquirer (MA). This paper proposes a novel approach by introducing an entity, mobile merchant acquirer (MMA) which is a trusted agent of MA and principally works on man in middle concept, but facilitates remote two fold mutual authentication and secure transaction transfer between Merchant and MA through MMA. This approach removes the bottle-neck of connectivity issues between Merchant and MA in limited connectivity environment. The proposed protocol ensures the confidentiality, integrity and money atomicity of transaction batch. The proposed protocol has been verified for correctness by Spin, a model checker and security properties of the protocol have been verified by avispa.

Assessment of human epidermal model LabCyte EPI-MODEL for in vitro skin irritation testing according to European Centre for the Validation of Alternative Methods (ECVAM)-validated protocol.

PubMed

Katoh, Masakazu; Hamajima, Fumiyasu; Ogasawara, Takahiro; Hata, Ken-Ichiro

2009-06-01

A validation study of an in vitro skin irritation testing method using a reconstructed human skin model has been conducted by the European Centre for the Validation of Alternative Methods (ECVAM), and a protocol using EpiSkin (SkinEthic, France) has been approved. The structural and performance criteria of skin models for testing are defined in the ECVAM Performance Standards announced along with the approval. We have performed several evaluations of the new reconstructed human epidermal model LabCyte EPI-MODEL, and confirmed that it is applicable to skin irritation testing as defined in the ECVAM Performance Standards. We selected 19 materials (nine irritants and ten non-irritants) available in Japan as test chemicals among the 20 reference chemicals described in the ECVAM Performance Standard. A test chemical was applied to the surface of the LabCyte EPI-MODEL for 15 min, after which it was completely removed and the model then post-incubated for 42 hr. Cell v iability was measured by MTT assay and skin irritancy of the test chemical evaluated. In addition, interleukin-1 alpha (IL-1alpha) concentration in the culture supernatant after post-incubation was measured to provide a complementary evaluation of skin irritation. Evaluation of the 19 test chemicals resulted in 79% accuracy, 78% sensitivity and 80% specificity, confirming that the in vitro skin irritancy of the LabCyte EPI-MODEL correlates highly with in vivo skin irritation. These results suggest that LabCyte EPI-MODEL is applicable to the skin irritation testing protocol set out in the ECVAM Performance Standards.

Questionable accuracy of home blood pressure measurements in the obese population - Validation of the Microlife WatchBP O3® and Omron RS6® devices according to the European Society of Hypertension-International Protocol.

PubMed

Azaki, Alaa; Diab, Reem; Harb, Aya; Asmar, Roland; Chahine, Mirna N

2017-01-01

Two oscillometric devices, the Microlife WatchBP O3 ® and the Omron RS6 ® , designed for self-blood pressure measurement were evaluated according to the European Society of Hypertension (ESH)-International Protocol (IP) Revision 2010 in the obese population. The Microlife WatchBP O3 measures blood pressure (BP) at the brachial level and the Omron RS6 measures BP at the wrist level. The ESH-IP revision 2010 includes a total of 33 subjects. The difference between observers' and device BP values was calculated for each measure. A total of 99 pairs of BP differences were classified into three categories (≤5, ≤10, and ≤15 mmHg). The protocol procedures were followed precisely in each of the two studies. Microlife WatchBP O3 and Omron RS6 failed to fulfill the criteria of the ESH-IP. The mean differences between the device and the mercury readings were: 0.3±7.8 mmHg and -1.9±6.4 mmHg for systolic BP and diastolic BP, respectively, for Microlife WatchBP O3, and 2.7±9.9 mmHg for SBP and 3.5±11.1 mmHg for diastolic BP for Omron RS6. Microlife WatchBP O3 and Omron RS6 readings differing from the mercury standard by more than 5, 10, and 15 mmHg failed to fulfill the ESH-IP revision 2010 requirements in obese subjects. Therefore, the two devices cannot be recommended for use in obese subjects.

Retrospective study of mortality in Asiatic lions (Panthera leo persica) in the European breeding population between 2000 and 2014.

PubMed

Metz, Olivia; Williams, Jonathan; Nielsen, Rikke Kruse; Masters, Nic

2017-01-01

Although the European population of Asiatic lions (Panthera leo persica) has been managed under the European Endangered Species Program (EEP) since 1990, little is known about the health status of the population. This study was designed to characterize mortality for this population through examination of the studbook and other records on 392 Asiatic lions living in the EEP between 2000 and 2014. A total of 270 animals died during the period with 80% of them being under 1 year old. The mortality rate for under 1 year olds was 54%, while the odds of survival of cubs within a litter increased if the dam had had litters previously. Survival to reproductive age was 44%. Post-mortem reports were requested and the cause of death was obtained for 133 animals. Trauma inflicted by a conspecific and lack of care were common causes of death (26% and 22%, respectively) and were also responsible for most of the neonatal mortalities. Congenital defects were responsible for 9% of deaths, although the true prevalence is likely underestimated. A common necropsy protocol for all Asiatic lion collections is needed to facilitate future studies. Zoo Biol. 36:66-73, 2017. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

Interlaboratory variability in screening for Bonamia ostreae, a protistan parasite of the European flat oyster Ostrea edulis.

PubMed

Flannery, Grace; Lynch, Sharon A; Longshaw, Matt; Stone, David; Martin, Paul; Ramilo, Andrea; Villalba, Antonio; Culloty, Sarah C

2014-07-24

The spread of the protozoan parasite Bonamia ostreae is of major concern to the European flat oyster Ostrea edulis industry. Many studies have looked at the sensitivity of individual methods available to screen for B. ostreae, but in this study, 3 separate laboratories examined 4 methods of diagnosis currently used routinely in laboratories: heart imprints, histology, polymerase chain reaction (PCR) and in situ hybridisation (ISH). The results were compared to estimate interlaboratory variability. Heart imprints and histology had the highest reproducibility amongst the 3 laboratories, with greatest agreement between detection of infected and uninfected individuals. PCR had the highest detection level in every laboratory. These positives were related to the presence of confirmed infections but also in unconfirmed infections, possibly due to the presence of traces of B. ostreae DNA in oysters where clinical infections were not observed. PCR, in combination with histology or ISH, provided the most reliable detection levels in every laboratory. Variation in results for PCR and ISH observed between laboratories may be due to the different protocols used by each laboratory for both methods. Overall, the findings from the 3 laboratories indicated that at least 2 methods, with fixed protocols, should be used for the accurate detection and determination of infection prevalence within a sample. This combination of methods would allow for a clearer and more precise diagnosis of B. ostreae, preventing further spread of the disease and providing more accurate detection levels and epidemiological information.

The risk of acute liver injury associated with the use of antibiotics--evaluating robustness of results in the pharmacoepidemiological research on outcomes of therapeutics by a European consortium (PROTECT) project.

PubMed

Udo, Renate; Tcherny-Lessenot, Stéphanie; Brauer, Ruth; Dolin, Paul; Irvine, David; Wang, Yunxun; Auclert, Laurent; Juhaeri, Juhaeri; Kurz, Xavier; Abenhaim, Lucien; Grimaldi, Lamiae; De Bruin, Marie L

2016-03-01

To examine the robustness of findings of case-control studies on the association between acute liver injury (ALI) and antibiotic use in the following different situations: (i) Replication of a protocol in different databases, with different data types, as well as replication in the same database, but performed by a different research team. (ii) Varying algorithms to identify cases, with and without manual case validation. (iii) Different exposure windows for time at risk. Five case-control studies in four different databases were performed with a common study protocol as starting point to harmonize study outcome definitions, exposure definitions and statistical analyses. All five studies showed an increased risk of ALI associated with antibiotic use ranging from OR 2.6 (95% CI 1.3-5.4) to 7.7 (95% CI 2.0-29.3). Comparable trends could be observed in the five studies: (i) without manual validation the use of the narrowest definition for ALI showed higher risk estimates, (ii) narrow and broad algorithm definitions followed by manual validation of cases resulted in similar risk estimates, and (iii) the use of a larger window (30 days vs 14 days) to define time at risk led to a decrease in risk estimates. Reproduction of a study using a predefined protocol in different database settings is feasible, although assumptions had to be made and amendments in the protocol were inevitable. Despite differences, the strength of association was comparable between the studies. In addition, the impact of varying outcome definitions and time windows showed similar trends within the data sources. Copyright © 2015 John Wiley & Sons, Ltd.

Implications of the field sampling procedure of the LUCAS Topsoil Survey for uncertainty in soil organic carbon concentrations.

NASA Astrophysics Data System (ADS)

Lark, R. M.; Rawlins, B. G.; Lark, T. A.

2014-05-01

The LUCAS Topsoil survey is a pan-European Union initiative in which soil data were collected according to standard protocols from 19 967 sites. Any inference about soil variables is subject to uncertainty due to different sources of variability in the data. In this study we examine the likely magnitude of uncertainty due to the field-sampling protocol. The published sampling protocol (LUCAS, 2009) describes a procedure to form a composite soil sample from aliquots collected to a depth of between approximately 15-20. A v-shaped hole to the target depth is cut with a spade, then a slice is cut from one of the exposed surfaces. This methodology gives rather less control of the sampling depth than protocols used in other soil and geochemical surveys, this may be a substantial source of variation in uncultivated soils with strong contrasts between an organic-rich A-horizon and an underlying B-horizon. We extracted all representative profile descriptions from soil series recorded in the memoir of the 1:250 000-scale map of Northern England (Soil Survey of England and Wales, 1984) where the base of the A-horizon is less than 20 cm below the surface. The Soil Associations in which these 14 series are significant members cover approximately 17% of the area of Northern England, and are expected to be the mineral soils with the largest organic content. Soil Organic Carbon content and bulk density were extracted for the A- and B-horizons, along with the thickness of the horizons. Recorded bulk density, or prediction by a pedotransfer function, were also recorded. For any proposed angle of the v-shaped hole, the proportions of A- and B-horizon in the resulting sample may be computed by trigonometry. From the bulk density and SOC concentration of the horizons, the SOC concentration of the sample can be computed. For each Soil Series we drew 1000 random samples from a trapezoidal distribution of angles, with uniform density over the range corresponding to depths 15-20 cm and zero density for angles corresponding to depths larger than 21 cm or less than 14 cm. We computed the corresponding variance of sample SOC contents. We found that the variance in SOC determinations attributable to variation in sample depth for these uncultivated soils was of the same order of magnitude as the estimate of the subsampling + analytical variance component (both on a log scale) that we previously computed for soils in the UK (Rawlins et al., 2009). It seems unnecessary to accept this source of uncertainty, given the effort undertaken to reduce the analytical variation which is no larger (and often smaller) than this variation due to the field protocol. If pan-European soil monitoring is to be based on the LUCAS Topsoil survey, as suggested by an initial report, uncertainty could be reduced if the sampling depth was specified to a unique depth, rather than the current depth range. LUCAS. 2009. Instructions for Surveyors. Technical reference document C-1: General implementation, Land Cover and Use, Water management, Soil, Transect, Photos. European Commission, Eurostat. Rawlins, B.G., Scheib, A.J., Lark, R.M. & Lister, T.R. 2009. Sampling and analytical plus subsampling variance components for five soil indicators observed at regional scale. European Journal of Soil Science 60, 740-747

Top-down emission estimation of European sources of halogenated hydrocarbons using a Kalman-filter based inversion

NASA Astrophysics Data System (ADS)

Brunner, Dominik; Henne, Stephan; Keller, Christoph A.; Reimann, Stefan; Vollmer, Martin K.; O'Doherty, Simon

2010-05-01

Halogenated hydrocarbons in the atmosphere are mostly synthetic products of the chemical industry designed for a wide range of applications. The first generation of compounds, the bromine- and chlorine-containing halons and chlorofluorocarbons (CFCs), were shown to be harmful to the stratospheric ozone layer. This motivated the international community to initiate the Montreal Protocol in 1987 to phase out their production globally. In the industrialized countries CFCs were consequently replaced by the shorter-lived hydrochlorofluorocarbons (HCFCs) during the 1990s and thereafter by the completely chlorine-free HFCs. Although not harmful to the ozone layer anymore, some of the HFCs are potent greenhouse gases and are therefore regulated under the Kyoto Protocol. The high-alpine station Jungfraujoch and the coastal station Mace Head are two of only four sites of the European SOGE network (System for Observation of Halogenated Greenhouse Gases in Europe) with high-frequency measurements of halogenated compounds. Based on observations at these two sites, we here present a combined measurement - model analysis of the distribution of European emissions for a selection of compounds, and trace their evolution with time since measurements started in 2000. For the spatial allocation of sources, the measurements were combined with detailed transport simulations. For a qualitative allocation of sources in Europe we employed the trajectory statistics method of Seibert et al. (1994) and Stohl (1996). For Mace Head trajectories were computed with the FLEXPART model driven by ECMWF analyzed winds at 1°x1° resolution. For the station Jungfraujoch, however, we used the model COSMO-TRAJ driven by high-resolution wind fields (7 km x 7 km) of the weather forecast model COSMO of MeteoSwiss in order to better represent the transport in complex topography over the Alps. The method allows identifying the major source regions of the different compounds in Western and Central Europe. The pesticide methyl bromide (CH3Br), for example, was applied primarily in southern Europe to protect vegetable and strawberry plantations. Its production was banned by the Montreal Protocol which is reflected by a strong reduction in emissions between 2003 and 2008 as seen from Jungfraujoch. A contrasting example is the cooling agent HFC-125 belonging to the second generation of replacement compounds not regulated under the Montreal Protocol. During the same period, HFC-125 exhibited a marked increase with sources more homogeneously spread over Europe than those of CH3Br. For a more quantitative analysis for the years 2007-2009, we applied the Lagrangian Particle Dispersion Model FLEXPART using meteorological input data of the IFS model of ECMWF at 0.2° x 0.2° resolution, together with a new source inversion method based on sequential Kalman filtering. Different from other approaches the method is essentially independent of an a-priori and adjusts both the emission field and the trace gas background levels in an iterative fashion. In this study, we will contrast results of the trajectory statistics method with the more advanced source inversion, address uncertainties in the methods, and show the evolution of European emissions of a selection of compounds in comparison to official numbers reported by the individual countries to the Montreal and Kyoto protocols, respectively.

Navigating the Unfamiliar in a Quest towards Culturally Responsive Pedagogy in the Classroom

ERIC Educational Resources Information Center

Baskerville, Delia

2009-01-01

This paper examines a New Zealand "Pakeha" (European) teacher's professional development experience working with "Maori" (indigenous people of New Zealand), and their protocols and practices. A "Maori kaumatua" (male leader) experienced in theatre direction, acting, and psychiatric nursing led "Maori"…

Prognosis of atypical teratoid rhabdoid tumors (AT/RT) treated with multimodal therapy protocols. Report of our series.

PubMed

Valencia-Moya, Alfonso; González-García, Laura; Ros-López, Bienvenido; Acha-García, Tomás; Weil-Lara, Bernardo; Obando-Pacheco, Pablo; Arráez-Sánchez, Miguel Ángel

2016-01-01

Atypical teratoid rhabdoid tumors (AT/RT) of the central nervous system are rare, very aggressive embryological tumors, typically diagnosed in young patients and having a low survival rate after diagnosis. The aim of this study was to emphasize, based on the latest results in the literature, the need for protocols for multidisciplinary treatment in these patients. We report our series of 3 cases treated, diagnosed and followed up between 2009 and 2014. They were treated with multimodal therapy protocols (Rhabdoid SIOP-2007 and European Rhabdoid Registry EU-RHAB-2010). In addition, we carried out a literature review. Two of our 3 cases (supratentorial and spinal tumors) did not show any progression of the disease after long follow-up, in contrast with most of the cases available in the literature. The second patient had a shorter survival. Patient age at the time of diagnosis, supratentorial location of the mass and fewer complications with adjuvant treatments seem to be factors yielding good prognosis for AT/RT tumors. In agreement with the latest international protocols, multidisciplinary treatment is the ideal treatment, consisting of radiotherapy and chemotherapy after complete tumor resection. Copyright © 2014 Sociedad Española de Neurocirugía. Published by Elsevier España. All rights reserved.

Refining animal models in fracture research: seeking consensus in optimising both animal welfare and scientific validity for appropriate biomedical use.

PubMed

Auer, Jorg A; Goodship, Allen; Arnoczky, Steven; Pearce, Simon; Price, Jill; Claes, Lutz; von Rechenberg, Brigitte; Hofmann-Amtenbrinck, Margarethe; Schneider, Erich; Müller-Terpitz, R; Thiele, F; Rippe, Klaus-Peter; Grainger, David W

2007-08-01

In an attempt to establish some consensus on the proper use and design of experimental animal models in musculoskeletal research, AOVET (the veterinary specialty group of the AO Foundation) in concert with the AO Research Institute (ARI), and the European Academy for the Study of Scientific and Technological Advance, convened a group of musculoskeletal researchers, veterinarians, legal experts, and ethicists to discuss, in a frank and open forum, the use of animals in musculoskeletal research. The group narrowed the field to fracture research. The consensus opinion resulting from this workshop can be summarized as follows: Anaesthesia and pain management protocols for research animals should follow standard protocols applied in clinical work for the species involved. This will improve morbidity and mortality outcomes. A database should be established to facilitate selection of anaesthesia and pain management protocols for specific experimental surgical procedures and adopted as an International Standard (IS) according to animal species selected. A list of 10 golden rules and requirements for conduction of animal experiments in musculoskeletal research was drawn up comprising 1) Intelligent study designs to receive appropriate answers; 2) Minimal complication rates (5 to max. 10%); 3) Defined end-points for both welfare and scientific outputs analogous to quality assessment (QA) audit of protocols in GLP studies; 4) Sufficient details for materials and methods applied; 5) Potentially confounding variables (genetic background, seasonal, hormonal, size, histological, and biomechanical differences); 6) Post-operative management with emphasis on analgesia and follow-up examinations; 7) Study protocols to satisfy criteria established for a "justified animal study"; 8) Surgical expertise to conduct surgery on animals; 9) Pilot studies as a critical part of model validation and powering of the definitive study design; 10) Criteria for funding agencies to include requirements related to animal experiments as part of the overall scientific proposal review protocols. Such agencies are also encouraged to seriously consider and adopt the recommendations described here when awarding funds for specific projects. Specific new requirements and mandates related both to improving the welfare and scientific rigour of animal-based research models are urgently needed as part of international harmonization of standards.

Validation of the BPUMP BF1112 upper-arm blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010.

PubMed

Chen, Qi; Kang, Yuan-Yuan; Li, Yan; Wang, Ji-Guang

2017-04-01

The present study aimed to evaluate the accuracy of the automated oscillometric upper-arm blood pressure (BP) monitor BPUMP BF1112 for home BP monitoring according to the International Protocol of the European Society of Hypertension revision 2010 (ESH-IP2010). Systolic and diastolic BPs were sequentially measured in 33 adult Chinese (13 women, mean age 46.7 years) using a mercury sphygmomanometer (two observers) and the BF1112 device (one supervisor). A total of 99 pairs of comparisons were obtained from 33 participants for judgments in two parts with three grading phases. The BPUMP BF1112 device achieved the targets in part 1 of the validation study. The number of absolute differences between device and observers within 5, 10, and 15 mmHg was 85/99, 96/99, and 97/99, respectively, for systolic BP, and 83/99, 97/99, and 99/99, respectively, for diastolic BP. The device also fulfilled the criteria in part 2 of the validation study. A total of 31 and 30 participants for systolic and diastolic BP, respectively, had at least two of the three device-observer differences within 5 mmHg (required≥24mmHg). No participant for systolic or diastolic BP had all the three device-observer comparisons greater than 5 mmHg. The BPUMP BP monitor BF1112 has passed the requirements of the ESH-IP2010, and hence can be recommended for home use in adults.

Measurement of fecal elastase improves performance of newborn screening for cystic fibrosis.

PubMed

Barben, Juerg; Rueegg, Corina S; Jurca, Maja; Spalinger, Johannes; Kuehni, Claudia E

2016-05-01

The aim of newborn screening (NBS) for CF is to detect children with 'classic' CF where early treatment is possible and improves prognosis. Children with inconclusive CF diagnosis (CFSPID) should not be detected, as there is no evidence for improvement through early treatment. No algorithm in current NBS guidelines explains what to do when sweat test (ST) fails. This study compares the performance of three different algorithms for further diagnostic evaluations when first ST is unsuccessful, regarding the numbers of children detected with CF and CFSPID, and the time until a definite diagnosis. In Switzerland, CF-NBS was introduced in January 2011 using an IRT-DNA-IRT algorithm followed by a ST. In children, in whom ST was not possible (no or insufficient sweat), 3 different protocols were applied between 2011 and 2014: in 2011, ST was repeated until it was successful (protocol A), in 2012 we proceeded directly to diagnostic DNA testing (protocol B), and 2013-2014, fecal elastase (FE) was measured in the stool, in order to determine a pancreas insufficiency needing immediate treatment (protocol C). The ratio CF:CFSPID was 7:1 (27/4) with protocol A, 2:1 (22/10) with protocol B, and 14:1 (54/4) with protocol C. The mean time to definite diagnosis was significantly shorter with protocol C (33days) compared to protocol A or B (42 and 40days; p=0.014 compared to A, and p=0.036 compared to B). The algorithm for the diagnostic part of the newborn screening used in the CF centers is important and affects the performance of a CF-NBS program with regard to the ratio CF:CFSPID and the time until definite diagnosis. Our results suggest to include FE after initial sweat test failure in the CF-NBS guidelines to keep the proportion of CFSPID low and the time until definite diagnosis short. Copyright © 2016 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.

Recommendations on practice of conditioned pain modulation (CPM) testing.

PubMed

Yarnitsky, D; Bouhassira, D; Drewes, A M; Fillingim, R B; Granot, M; Hansson, P; Landau, R; Marchand, S; Matre, D; Nilsen, K B; Stubhaug, A; Treede, R D; Wilder-Smith, O H G

2015-07-01

Protocols for testing conditioned pain modulation (CPM) vary between different labs/clinics. In order to promote research and clinical application of this tool, we summarize the recommendations of interested researchers consensus meeting regarding the practice of CPM and report of its results. © 2014 European Pain Federation - EFIC®

75 FR 68364 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-05

... European Protocol for the Quality Control of the Physical and Technical Aspects of Mammography Screening... entitled ``Physical Laboratory Testing, Breast Compression System'' to follow the Mammography Quality...] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document...

An optimized 13C-urea breath test for the diagnosis of H pylori infection

PubMed Central

Campuzano-Maya, Germán

2007-01-01

AIM: To validate an optimized 13C-urea breath test (13C-UBT) protocol for the diagnosis of H pylori infection that is cost-efficient and maintains excellent diagnostic accuracy. METHODS: 70 healthy volunteers were tested with two simplified 13C-UBT protocols, with test meal (Protocol 2) and without test meal (Protocol 1). Breath samples were collected at 10, 20 and 30 min after ingestion of 50 mg 13C-urea dissolved in 10 mL of water, taken as a single swallow, followed by 200 mL of water (pH 6.0) and a circular motion around the waistline to homogenize the urea solution. Performance of both protocols was analyzed at various cut-off values. Results were validated against the European protocol. RESULTS: According to the reference protocol, 65.7% individuals were positive for H pylori infection and 34.3% were negative. There were no significant differences in the ability of both protocols to correctly identify positive and negative H pylori individuals. However, only Protocol 1 with no test meal achieved accuracy, sensitivity, specificity, positive and negative predictive values of 100%. The highest values achieved by Protocol 2 were 98.57%, 97.83%, 100%, 100% and 100%, respectively. CONCLUSION: A 10 min, 50 mg 13C-UBT with no test meal using a cut-off value of 2-2.5 is a highly accurate test for the diagnosis of H pylori infection at a reduced cost. PMID:17907288

Validation of the iHealth BP7 wrist blood pressure monitor, for self-measurement, according to the European Society of Hypertension International Protocol revision 2010.

PubMed

Wang, Qing; Zhao, Huadong; Chen, Wan; Li, Ni; Wan, Yi

2014-02-01

The aim of this study was to validate the iHealth BP7 wireless wrist blood pressure monitor according to the European Society of Hypertension International Protocol (ESH-IP) revision 2010. A total of 99 pairs of test device and reference blood pressure measurements (three pairs for each of the 33 participants) were obtained for validation. The ESH-IP revision 2010 for the validation of blood pressure measuring devices in adults was followed precisely. The device produced 66, 87, and 97 measurements within 5, 10, and 15 mmHg for systolic blood pressure (SBP) and 72, 93, and 99 mmHg for diastolic blood pressure (DBP), respectively. The mean±SD device-observer difference was -0.7±6.9 mmHg for SBP and -1.0±5.1 mmHg for DBP. The number of participants with two or three device-observer differences within 5 mmHg was 25 for SBP and 26 for DBP; furthermore, there were three participants for SBP and one participant for DBP, with none of the device-observer differences within 5 mmHg. On the basis of the validation results, the iHealth BP7 wireless wrist blood pressure monitor can be recommended for self-measurement in an adult population.

Major depression and fitness to fly by different aviation authorities.

PubMed

Vuorio, Alpo; Laukkala, Tanja; Navathe, Pooshan

2012-09-01

Safety issues are paramount in aviation and careful treatment protocols have been developed to ensure fitness to fly among aviators recovering from major depressive episodes (MDE). Aeromedical examiners (AMEs) do not necessarily treat depressive patients frequently, so they often consult psychiatrists; however, psychiatrists are rarely familiar with aviator treatment protocols. U.S., Canadian, and Australian regulations allow several choices among antidepressant drugs for flying pilots recovering from an MDE. Symptom stability times before the possible return to flying duties vary from 4 wk to 12 mo. So far European regulations have not allowed antidepressants, but the situation may change.

Explanation of the Nagoya Protocol on Access and Benefit Sharing and its implication for microbiology.

PubMed

Smith, David; da Silva, Manuela; Jackson, Julian; Lyal, Christopher

2017-03-01

Working with genetic resources and associated data requires greater attention since the Nagoya Protocol on Access and Benefit Sharing (ABS) came into force in October 2014. Biologists must ensure that they have legal clarity in how they can and cannot use the genetic resources on which they carry out research. Not only must they work within the spirit in the Convention on Biological Diversity (https://www.cbd.int/convention/articles/default.shtml?a=cbd-02) but also they may have regulatory requirements to meet. Although the Nagoya Protocol was negotiated and agreed globally, it is the responsibility of each country that ratifies it to introduce their individual implementing procedures and practices. Many countries in Europe, such as the UK, have chosen not to put access controls in place at this time, but others already have laws enacted providing ABS measures under the Convention on Biological Diversity or specifically to implement the Nagoya Protocol. Access legislation is in place in many countries and information on this can be found at the ABS Clearing House (https://absch.cbd.int/). For example, Brazil, although not a Party to the Nagoya Protocol at the time of writing, has Law 13.123 which entered into force on 17 November 2015, regulated by Decree 8.772 which was published on 11 May 2016. In this case, export of Brazilian genetic resources is not allowed unless the collector is registered in the National System for Genetic Heritage and Associated Traditional Knowledge Management (SisGen). The process entails that a foreign scientist must first of all be registered working with someone in Brazil and have authorization to collect. The enactment of European Union Regulation po. 511/2014 implements Nagoya Protocol elements that govern compliance measures for users and offers the opportunity to demonstrate due diligence in sourcing their organisms by selecting from holdings of 'registered collections'. The UK has introduced a Statutory Instrument that puts in place enforcement measures within the UK to implement this European Union Regulation; this is regulated by Regulatory Delivery, Department for Business, Energy and Industrial Strategies. Scientific communities, including the private sector, individual institutions and organizations, have begun to design policy and best practices for compliance. Microbiologists and culture collections alike need to be aware of the legislation of the source country of the materials they use and put in place best practices for compliance; such best practice has been drafted by the Microbial Resource Research Infrastructure, and other research communities such as the Consortium of European Taxonomic Facilities, the Global Genome Biodiversity Network and the International Organisation for Biological Control have published best practice and/or codes of conduct to ensure legitimate exchange and use of genetic resources.

Nanopharmaceuticals: Tiny challenges for the environmental risk assessment of pharmaceuticals.

PubMed

Berkner, Silvia; Schwirn, Kathrin; Voelker, Doris

2016-04-01

Many new developments and innovations in health care are based on nanotechnology. The field of nanopharmaceuticals is diverse and not as new as one might think; indeed, nanopharmaceuticals have been marketed for many years, and the future is likely to bring more nanosized compounds to the market. Therefore, it is time to examine whether the environmental risk assessment for human pharmaceuticals is prepared to assess the exposure, fate, and effects of nanopharmaceuticals in an adequate way. Challenges include the different definitions for nanomaterials and nanopharmaceuticals, different regulatory frameworks, the diversity of nanopharmaceuticals, the scope of current regulatory guidelines, and the applicability of test protocols. Based on the current environmental risk assessment for human medicinal products in the European Union, necessary adaptations for the assessment procedures and underlying study protocols are discussed and emerging solutions identified. © 2015 The Authors. Environmental Toxicology & Chemistry published by Wiley Periodicals, Inc. on behalf of SETAC.

[France, an attractive country for international clinical research: 2008 survey assessed by Leem (French association of pharmaceutical companies)].

PubMed

Lassale, Catherine; Sibenaler, Claire; Béhier, Jehan-Michel; Plétan, Yannick; Courcier, Soizic

2008-01-01

In order to evaluate the attractiveness of France for conducting international clinical trials, a survey is performed every two years among pharmaceutical companies that are based in France or have affiliates in France. Nineteen companies (61.9 % of the French market) have participated in the current survey which included 385 international phase II and III clinical studies, 77 countries, 29,708 centres and 312,835 patients (included in 2006/2007). France (400 patients/million inhabitants) ranked among the best European recruiters in second position behind Scandinavia. Since 2006, France has improved administrative processes and reduced deadlines for hospital contracts. Protocols are now to be given the go-ahead by French Authorities (Afssaps and CPP) within 60 days, in accordance with European directive. Its performance in early phases, oncology/hematology and vaccines/anti-infectious contribute to the attractiveness of France in international clinical research.

Real association of factors with inappropriate hospital days.

PubMed

Huet, Bernard; Cauterman, Maxime

2005-01-01

Several studies of inappropriate (in the sense of the AEP) hospital days highlighted associations between two factors (rate of inappropriateness and reasons for inappropriateness, rate of inappropriateness and appropriate setting of care,..). The aim of this communication is to present a study on real associations, at constant factor, between five factors associated with hospital inappropriate days: medical management process, reason for inappropriateness, scheduled admission, rate of inappropriateness, length of stay. We used the European version of Appropriateness Evaluation Protocol for evaluation of inappropriate days and the French protocol ;for analysis of inappropriate days. The study set in three Parisian hospitals, four clinical departments, three specialities. 523 patients were included in the study, 5663 days were evaluated on a wide variety of pathologies: 27 Medical Management Processes. Results show that there are real associations (elimination of transitive associations) between five factors : medical management process and discharge processes, reason for inappropriateness, scheduled admission, rate of inappropriate days, length of stay. Multiple Correspondence Analysis on all "groups of contiguous days related with the same reason for inappropriateness" shows five profiles of queues integrating various medical management processes.

Effect modification of FADS2 polymorphisms on the association between breastfeeding and intelligence: protocol for a collaborative meta-analysis

PubMed Central

Hartwig, Fernando Pires; Davies, Neil Martin; Horta, Bernardo Lessa; Victora, Cesar Gomes; Davey Smith, George

2016-01-01

Introduction Evidence from observational studies and randomised controlled trials suggests that breastfeeding is positively associated with IQ, possibly because breast milk is a source of long-chain polyunsaturated fatty acids. Different studies have detected gene-breastfeeding interactions involving FADS2 variants and intelligence. However, findings are inconsistent regarding the direction of such effect modification. Methods/design To clarify how FADS2 and breastfeeding interact in their association with IQ, we are conducting a consortium-based meta-analysis of independent studies. Results produced by each individual study using standardised analysis scripts and harmonised data will be used. Inclusion criteria: breastfeeding, IQ and either rs174575 or rs1535 polymorphisms available; and being of European ancestry. Exclusion criteria: twin studies; only poorly imputed genetic data available; or unavailability of proper ethics approval. Studies will be invited based on being known to have at least some of the required data, or suggested by participating studies as potentially eligible. This inclusive approach will favour achieving a larger sample size and be less prone to publication bias. Discussion Improving current understanding of FADS2-breastfeeding interaction may provide important biological insights regarding the importance of long-chain polyunsaturated fatty acids for the breastfeeding-IQ association. This meta-analysis will help to improve such knowledge by replicating earlier studies, conducting additional analysis and evaluating different sources of heterogeneity. Publishing this protocol will minimise the possibility of bias due to post hoc changes to the analysis protocol. PMID:27311901

Statistical controversies in clinical research: comparison of primary outcomes in protocols, public clinical-trial registries and publications: the example of oncology trials.

PubMed

Perlmutter, A S; Tran, V-T; Dechartres, A; Ravaud, P

2017-04-01

Protocols are often unavailable to peer-reviewers and readers. To detect outcome reporting bias (ORB), readers usually have to resort to publicly available descriptions of study design such as public clinical trial registries. We compared primary outcomes in protocols, ClinicalTrials.gov and publications of oncology trials and evaluated the use of ClinicalTrials.gov as compared with protocols in detecting discrepancies between planned and published outcomes. We searched for phase III oncology trials registered in ClinicalTrials.gov and published in the Journal of Clinical Oncology and New England Journal of Medicine between January 2014 and June 2015. We extracted primary outcomes reported in the protocol, ClinicalTrials.gov and the publication. First, we assessed the quality of primary outcome descriptions by using a published framework. Second, we evaluated modifications of primary outcomes between each source. Finally, we evaluated the agreement, specificity and sensitivity of detecting modifications between planned and published outcomes by using protocols or ClinicalTrials.gov. We included 65 trials, with 81 primary outcomes common among the 3 sources. The proportion of primary outcomes reporting all items from the framework was 73%, 22%, and 75% for protocols, ClinicalTrials.gov and publications, respectively. Eight (12%) trials presented a discrepancy between primary outcomes reported in the protocol and in the publication. Twelve (18.5%) trials presented a discrepancy between primary outcomes registered at ClinicalTrials.gov and in publications. We found a moderate agreement in detecting discrepant reporting of outcomes by using protocols or ClinicalTrials.gov [κ = 0.53, 95% confidence interval (0.25-0.81)]. Using ClinicalTrials.gov to detect discrepant reporting of outcomes showed high specificity (89.5%) but lacked sensitivity (75%) as compared with use of protocols. In oncology trials, primary outcome descriptions in ClinicalTrials.gov are often of low quality and may not reflect what is in the protocol, thus limiting the detection of modifications between planned and published outcomes. © The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Policy Guidelines for Effective Inclusion and Reintegration of People with Chronic Diseases in the Workplace: National and European Perspectives

PubMed Central

Vlachou, Anastasia; Stavroussi, Panayiota; Roka, Olga; Vasilou, Evdokia; Papadimitriou, Dimitra; Scaratti, Chiara; Kadyrbaeva, Asel; Brecelj, Valentina; Svestkova, Olga; Tobiasz-Adamczyk, Beata; Finnvold, Jon Erik; Gruber, Sonja

2018-01-01

The increasing prevalence of chronic diseases among the European working age population, as well as the implications for the individual and societal level, underline the need for policy guidelines targeting the effective inclusion of persons with chronic diseases in the workplace. The aim of the present paper was to explore the perspectives of European and National-level stakeholders on existing strategies for work re-integration of persons with chronic diseases, and to provide policy guidelines. A highly-structured interview protocol was distributed to 58 National level stakeholders (policy makers, professionals and employers) from seven European countries. Additionally, 20 European organizations concerned with health-related issues and employment completed an online survey. The findings reveal that employment-related challenges remain largely unaddressed. Both national and European stakeholders considered the existing legislative frameworks inadequate and appraised the co-ordination for the implementation of employment re-integration policies as ineffective. Policies targeting at work re-integration of persons with chronic diseases at European and national level should focus on consistent cooperation among all key stakeholders, awareness raising to staff and management, dissemination of effective strategies, developing research and evaluation standards and establishing monitoring systems on inclusive labour markets. PMID:29534484

Standardisation of a European measurement method for organic carbon and elemental carbon in ambient air: results of the field trial campaign and the determination of a measurement uncertainty and working range.

PubMed

Brown, Richard J C; Beccaceci, Sonya; Butterfield, David M; Quincey, Paul G; Harris, Peter M; Maggos, Thomas; Panteliadis, Pavlos; John, Astrid; Jedynska, Aleksandra; Kuhlbusch, Thomas A J; Putaud, Jean-Philippe; Karanasiou, Angeliki

2017-10-18

The European Committee for Standardisation (CEN) Technical Committee 264 'Air Quality' has recently produced a standard method for the measurements of organic carbon and elemental carbon in PM 2.5 within its working group 35 in response to the requirements of European Directive 2008/50/EC. It is expected that this method will be used in future by all Member States making measurements of the carbonaceous content of PM 2.5 . This paper details the results of a laboratory and field measurement campaign and the statistical analysis performed to validate the standard method, assess its uncertainty and define its working range to provide clarity and confidence in the underpinning science for future users of the method. The statistical analysis showed that the expanded combined uncertainty for transmittance protocol measurements of OC, EC and TC is expected to be below 25%, at the 95% level of confidence, above filter loadings of 2 μg cm -2 . An estimation of the detection limit of the method for total carbon was 2 μg cm -2 . As a result of the laboratory and field measurement campaign the EUSAAR2 transmittance measurement protocol was chosen as the basis of the standard method EN 16909:2017.

Networking seismological data exchange in Europe

NASA Astrophysics Data System (ADS)

Sleeman, Reinoud; van Eck, Torild; van den Hazel, Gert-Jan; Trani, Luca; Spinuso, Alessandro

2010-05-01

The mission of the ORFEUS Data Centre (ODC) is to collect and archive high-quality seismic broadband waveform data from European-Mediterranean organizations and to provide open access to this data for monitoring and research purposes by the scientific community. The core activity of the ODC is to run an automatic, sustainable system to achieve this mission. Our 4 key operations are: data exchange protocols, quality control procedures, data management and data services. All these activities at the ODC benefit from developments within the EC Infrastructure (I3) project NERIES (Network of Research Infrastructure for European Seismology). For the data acquisition the ODC uses different standard, real-time data exchange protocols (e.g. Antelope, SeedLink, Scream) to ensure a very high data availability from stations in the Virtual European Broadband Seismic Network (VEBSN), which currently exists of about 500 BB stations. Within the data services a number of tools (e.g. Wilber II, NetDC, BreqFast, AutoDRM and webforms) are in place to serve the scientific community. These are currently being complemented by webservices and an integrated portal. The data management part relies on a simple flat file structure and a MySQL data management system on which both ArcLink and the Generic Data Interface (GDI) operate. In this presentation we will present an overview of the different aspects concerning data acquisition, services and management at ODC.

Quality of Care and Job Satisfaction in the European Home Care Setting: Research Protocol

PubMed Central

van der Roest, Henriëtte; van Hout, Hein; Declercq, Anja

2016-01-01

Introduction: Since the European population is ageing, a growing number of elderly will need home care. Consequently, high quality home care for the elderly remains an important challenge. Job satisfaction among care professionals is regarded as an important aspect of the quality of home care. Aim: This paper describes a research protocol to identify elements that have an impact on job satisfaction among care professionals and on quality of care for older people in the home care setting of six European countries. Methods: Data on elements at the macro-level (policy), meso-level (care organisations) and micro-level (clients) are of importance in determining job satisfaction and quality of care. Macro-level indicators will be identified in a previously published literature review. At meso- and micro-level, data will be collected by means of two questionnaires utilsed with both care organisations and care professionals, and by means of interRAI Home Care assessments of clients. The client assessments will be used to calculate quality of care indicators. Subsequently, data will be analysed by means of linear and stepwise multiple regression analyses, correlations and multilevel techniques. Conclusions and Discussion: These results can guide health care policy makers in their decision making process in order to increase the quality of home care in their organisation, in their country or in Europe. PMID:28435423

European Birth Cohorts for Environmental Health Research

PubMed Central

Casas, Maribel; Bergström, Anna; Carmichael, Amanda; Cordier, Sylvaine; Eggesbø, Merete; Eller, Esben; Fantini, Maria P.; Fernández, Mariana F.; Fernández-Somoano, Ana; Gehring, Ulrike; Grazuleviciene, Regina; Hohmann, Cynthia; Karvonen, Anne M.; Keil, Thomas; Kogevinas, Manolis; Koppen, Gudrun; Krämer, Ursula; Kuehni, Claudia E.; Magnus, Per; Majewska, Renata; Andersen, Anne-Marie Nybo; Patelarou, Evridiki; Petersen, Maria Skaalum; Pierik, Frank H.; Polanska, Kinga; Porta, Daniela; Richiardi, Lorenzo; Santos, Ana Cristina; Slama, Rémy; Sram, Radim J.; Thijs, Carel; Tischer, Christina; Toft, Gunnar; Trnovec, Tomáš; Vandentorren, Stephanie; Vrijkotte, Tanja G.M.; Wilhelm, Michael; Wright, John; Nieuwenhuijsen, Mark

2011-01-01

Background: Many pregnancy and birth cohort studies investigate the health effects of early-life environmental contaminant exposure. An overview of existing studies and their data is needed to improve collaboration, harmonization, and future project planning. Objectives: Our goal was to create a comprehensive overview of European birth cohorts with environmental exposure data. Methods: Birth cohort studies were included if they a) collected data on at least one environmental exposure, b) started enrollment during pregnancy or at birth, c) included at least one follow-up point after birth, d) included at least 200 mother–child pairs, and e) were based in a European country. A questionnaire collected information on basic protocol details and exposure and health outcome assessments, including specific contaminants, methods and samples, timing, and number of subjects. A full inventory can be searched on www.birthcohortsenrieco.net. Results: Questionnaires were completed by 37 cohort studies of > 350,000 mother–child pairs in 19 European countries. Only three cohorts did not participate. All cohorts collected biological specimens of children or parents. Many cohorts collected information on passive smoking (n = 36), maternal occupation (n = 33), outdoor air pollution (n = 27), and allergens/biological organisms (n = 27). Fewer cohorts (n = 12–19) collected information on water contamination, ionizing or nonionizing radiation exposures, noise, metals, persistent organic pollutants, or other pollutants. All cohorts have information on birth outcomes; nearly all on asthma, allergies, childhood growth and obesity; and 26 collected information on child neurodevelopment. Conclusion: Combining forces in this field will yield more efficient and conclusive studies and ultimately improve causal inference. This impressive resource of existing birth cohort data could form the basis for longer-term and worldwide coordination of research on environment and child health. PMID:21878421

A pilot study on the feasibility of European harmonized human biomonitoring: Strategies towards a common approach, challenges and opportunities.

PubMed

Casteleyn, L; Dumez, B; Becker, K; Kolossa-Gehring, M; Den Hond, E; Schoeters, G; Castaño, A; Koch, H M; Angerer, J; Esteban, M; Exley, K; Sepai, O; Bloemen, L; Horvat, M; Knudsen, L E; Joas, A; Joas, R; Biot, P; Koppen, G; Dewolf, M-C; Katsonouri, A; Hadjipanayis, A; Cerná, M; Krsková, A; Schwedler, G; Fiddicke, U; Nielsen, J K S; Jensen, J F; Rudnai, P; Közepésy, S; Mulcahy, M; Mannion, R; Gutleb, A C; Fischer, M E; Ligocka, D; Jakubowski, M; Reis, M F; Namorado, S; Lupsa, I-R; Gurzau, A E; Halzlova, K; Jajcaj, M; Mazej, D; Tratnik Snoj, J; Posada, M; López, E; Berglund, M; Larsson, K; Lehmann, A; Crettaz, P; Aerts, D

2015-08-01

In 2004 the European Commission and Member States initiated activities towards a harmonized approach for Human Biomonitoring surveys throughout Europe. The main objective was to sustain environmental health policy by building a coherent and sustainable framework and by increasing the comparability of data across countries. A pilot study to test common guidelines for setting up surveys was considered a key step in this process. Through a bottom-up approach that included all stakeholders, a joint study protocol was elaborated. From September 2011 till February 2012, 17 European countries collected data from 1844 mother-child pairs in the frame of DEMOnstration of a study to COordinate and Perform Human Biomonitoring on a European Scale (DEMOCOPHES).(1) Mercury in hair and urinary cadmium and cotinine were selected as biomarkers of exposure covered by sufficient analytical experience. Phthalate metabolites and Bisphenol A in urine were added to take into account increasing public and political awareness for emerging types of contaminants and to test less advanced markers/markers covered by less analytical experience. Extensive efforts towards chemo-analytical comparability were included. The pilot study showed that common approaches can be found in a context of considerable differences with respect to experience and expertize, socio-cultural background, economic situation and national priorities. It also evidenced that comparable Human Biomonitoring results can be obtained in such context. A European network was built, exchanging information, expertize and experiences, and providing training on all aspects of a survey. A key challenge was finding the right balance between a rigid structure allowing maximal comparability and a flexible approach increasing feasibility and capacity building. Next steps in European harmonization in Human Biomonitoring surveys include the establishment of a joint process for prioritization of substances to cover and biomarkers to develop, linking biomonitoring surveys with health examination surveys and with research, and coping with the diverse implementations of EU regulations and international guidelines with respect to ethics and privacy. Copyright © 2014 Elsevier Inc. All rights reserved.

Assessment of the smoke-free outdoor regulation in the WHO European Region.

PubMed

Martínez, Cristina; Guydish, Joseph; Robinson, Gillian; Martínez-Sánchez, Jose María; Fernández, Esteve

2014-07-01

The aim of this study is to assess the level of protection of secondhand smoke in outdoor locations among countries belonging to the WHO European Region. This cross-sectional study measures the level of protection provided by laws in outdoor locations. A protocol to evaluate the outdoor smoke-free legislation was developed according to the recommendations provided by the WHO Guidelines for implementing smoke-free outdoor places. For each law 6 main sectors and 28 outdoor locations were evaluated. 68 laws from 48 countries were reviewed, totally assessing 1758 locations. Overall 3.1% of the locations specified 100% smoke-free outdoor regulation without exceptions, 2.5% permitted smoking in designated outdoor areas, 37.5% allowed smoking everywhere, and 56.9% did not provide information about how to deal with smoking in outdoor places. In the Education sector 17.8% of the laws specified smoke-free outdoor regulation, mainly in the primary and secondary schools. Three pioneering laws from recreational locations and two from general health facilities specified 100% outdoor smoke-free regulation. Outdoor smoke-free policies among countries belonging to the WHO European Region are limited and mainly have been passed in the primary and secondary schools, which protect minors from the hazards of secondhand smoke in educational settings. Copyright © 2014 Elsevier Inc. All rights reserved.

The impact of perioperative fluid therapy on short-term outcomes and 5-year survival among patients undergoing colorectal cancer surgery - A prospective cohort study within an ERAS protocol.

PubMed

Asklid, D; Segelman, J; Gedda, C; Hjern, F; Pekkari, K; Gustafsson, U O

2017-08-01

Restricted perioperative fluid therapy is one of several interventions in the enhanced recovery after surgery (ERAS) protocol, designed to reduce morbidity and hospital stay after surgery. The impact of this single intervention on short and long term outcome after colorectal surgery is unknown. This cohort study includes all consecutive patients operated with abdominal resection of colorectal cancer 2002-2007 at Ersta Hospital, Stockholm, Sweden. All patients were treated within an ERAS protocol and registered in the ERAS-database. Compliance to interventions in the ERAS protocol was analysed. The impact of a restrictive perioperative fluid therapy (≤3000 ml on the day of surgery) protocol on short-term outcomes as well as 5-year survival was assessed with multivariable analysis adjusted for confounding factors. Nine hundred and eleven patients were included. Patients receiving ≤3000 ml of intravenous fluids on the day of surgery had a lower risk of complications OR 0.44 (95% C I 0.28-0.71), symptoms delaying discharge OR 0.47(95% C I 0.32-0.70) and shorter length of stay compared with patients receiving >3000 ml. In cox regression analysis, the risk of cancer specific death was reduced with 55% HR 0.45(95% C I 0.25-0.81) for patients receiving ≤ 3000 ml compared with patients receiving >3000 ml. A restrictive compared with a non-restrictive perioperative fluid therapy on the day of surgery may be associated with lower short-term complication rates, faster recovery, shorter length of stay and improved 5-year survival. Copyright © 2017 Elsevier Ltd, BASO ~ The Association for Cancer Surgery, and the European Society of Surgical Oncology. All rights reserved.

The Eastern European experience on occupational skin diseases. Make underreporting an issue?

PubMed

Moldovan, H R; Voidazan, S T; John, S M; Weinert, P; Moldovan, G; Vlasiu, M A; Szasz, Z A; Tiplica, G S; Szasz, S; Marin, A C; Salavastru, C M

2017-06-01

While legislation in most of the Eastern European countries is nowadays widely harmonized with the legal safety and health provisions of Western countries, there is still a sustained resistance to the notification of occupational skin diseases (OSD). The aim of the study was to identify the main barriers in notification and recognition of OSD in 22 Eastern European countries. An online survey was administered to key persons in the field of occupational safety and health in 22 Eastern European countries. Multiple variables of the notification system were studied, including clinical, organizational and educational issues. The main causes of underreporting OSD are ineffective enforcement of occupational safety and health legislation, contractual relationship employer-employee, long duration of the notifying process, restrictions of the notification systems in terms of who is entitled to notify an OSD, ineffective regulations in regards to the pre-employment and periodical medical examination, ineffective compensation schemes, restraints and hesitations, mainly from the doctors, inappropriate mentalities - fear of losing the jobs, fining of the employers by the authorities, stigmatization of the workers with OSD, additional costs for employers, stakeholders' lack of interest in notifying, lack of guidelines and protocols and lack of preventive programmes. The most valuable method for a proper recognition of OSD is to increase the awareness of physicians involved in the management of OSD (occupational physicians, GPs, dermatologists), as well as employers and workers. There is an urgent need to improve national legislation, to develop and promote adequate preventive programmes, emphasizing ethical, legal, economical and psychological aspects in order to achieve an increased recognition and a real reporting of OSD, and to enforce an international action plan for Eastern Europe in order to improve the notification of OSD. © 2017 European Academy of Dermatology and Venereology.

Global gene mining and the pharmaceutical industry

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

Knudsen, Lisbeth E.

2005-09-01

Worldwide efforts are ongoing in optimizing medical treatment by searching for the right medicine at the right dose for the individual. Metabolism is regulated by polymorphisms, which may be tested by relatively simple SNP analysis, however requiring DNA from the test individuals. Target genes for the efficiency of a given medicine or predisposition of a given disease are also subject to population studies, e.g., in Iceland, Estonia, Sweden, etc. For hypothesis testing and generation, several bio-banks with samples from patients and healthy persons within the pharmaceutical industry have been established during the past 10 years. Thus, more than 100,000 samplesmore » are stored in the freezers of either the pharmaceutical companies or their contractual partners at universities and test institutions. Ethical issues related to data protection of the individuals providing samples to bio-banks are several: nature and extent of information prior to consent, coverage of the consent given by the study person, labeling and storage of the sample and data (coded or anonymized). In general, genetic test data, once obtained, are permanent and cannot be changed. The test data may imply information that is not beneficial to the patient and his/her family (e.g., employment opportunities, insurance, etc.). Furthermore, there may be a long latency between the analysis of the genetic test and the clinical expression of the disease and wide differences in the disease patterns. Consequently, information about some genetic test data may stigmatize patients leading to poor quality of life. This has raised the issue of 'genetic exceptionalism' justifying specific regulation of use of genetic information. Discussions on how to handle sampling and data are ongoing within the industry and the regulatory sphere, the European Agency for the Evaluation of Medicinal Products (EMEA) having issued a position paper, the Council for International Organizations of Medical Sciences (CIOMS) having a working group on this issue, and the European Society of Human Genetics preparing background paper on 'Polymorphic sequence variants in medicine: Technical, social, legal and ethical issues. Pharmacogenetics as an example'. Within the European project Privacy in Research Ethics and Law (PRIVIREAL), recommendations for common European guidelines for membership in research ethical committees have been discussed, balancing the interests and assuring independence and legal competence. Good decision making, assuring legality of protocols and assessment of data protection is suggested to be part of any evaluation of protocols.« less

European Society for Swallowing Disorders - European Union Geriatric Medicine Society white paper: oropharyngeal dysphagia as a geriatric syndrome.

PubMed

Baijens, Laura Wj; Clavé, Pere; Cras, Patrick; Ekberg, Olle; Forster, Alexandre; Kolb, Gerald F; Leners, Jean-Claude; Masiero, Stefano; Mateos-Nozal, Jesús; Ortega, Omar; Smithard, David G; Speyer, Renée; Walshe, Margaret

2016-01-01

This position document has been developed by the Dysphagia Working Group, a committee of members from the European Society for Swallowing Disorders and the European Union Geriatric Medicine Society, and invited experts. It consists of 12 sections that cover all aspects of clinical management of oropharyngeal dysphagia (OD) related to geriatric medicine and discusses prevalence, quality of life, and legal and ethical issues, as well as health economics and social burden. OD constitutes impaired or uncomfortable transit of food or liquids from the oral cavity to the esophagus, and it is included in the World Health Organization's classification of diseases. It can cause severe complications such as malnutrition, dehydration, respiratory infections, aspiration pneumonia, and increased readmissions, institutionalization, and morbimortality. OD is a prevalent and serious problem among all phenotypes of older patients as oropharyngeal swallow response is impaired in older people and can cause aspiration. Despite its prevalence and severity, OD is still underdiagnosed and untreated in many medical centers. There are several validated clinical and instrumental methods (videofluoroscopy and fiberoptic endoscopic evaluation of swallowing) to diagnose OD, and treatment is mainly based on compensatory measures, although new treatments to stimulate the oropharyngeal swallow response are under research. OD matches the definition of a geriatric syndrome as it is highly prevalent among older people, is caused by multiple factors, is associated with several comorbidities and poor prognosis, and needs a multidimensional approach to be treated. OD should be given more importance and attention and thus be included in all standard screening protocols, treated, and regularly monitored to prevent its main complications. More research is needed to develop and standardize new treatments and management protocols for older patients with OD, which is a challenging mission for our societies.

European Society for Swallowing Disorders – European Union Geriatric Medicine Society white paper: oropharyngeal dysphagia as a geriatric syndrome

PubMed Central

Baijens, Laura WJ; Clavé, Pere; Cras, Patrick; Ekberg, Olle; Forster, Alexandre; Kolb, Gerald F; Leners, Jean-Claude; Masiero, Stefano; Mateos-Nozal, Jesús; Ortega, Omar; Smithard, David G; Speyer, Renée; Walshe, Margaret

2016-01-01

This position document has been developed by the Dysphagia Working Group, a committee of members from the European Society for Swallowing Disorders and the European Union Geriatric Medicine Society, and invited experts. It consists of 12 sections that cover all aspects of clinical management of oropharyngeal dysphagia (OD) related to geriatric medicine and discusses prevalence, quality of life, and legal and ethical issues, as well as health economics and social burden. OD constitutes impaired or uncomfortable transit of food or liquids from the oral cavity to the esophagus, and it is included in the World Health Organization’s classification of diseases. It can cause severe complications such as malnutrition, dehydration, respiratory infections, aspiration pneumonia, and increased readmissions, institutionalization, and morbimortality. OD is a prevalent and serious problem among all phenotypes of older patients as oropharyngeal swallow response is impaired in older people and can cause aspiration. Despite its prevalence and severity, OD is still underdiagnosed and untreated in many medical centers. There are several validated clinical and instrumental methods (videofluoroscopy and fiberoptic endoscopic evaluation of swallowing) to diagnose OD, and treatment is mainly based on compensatory measures, although new treatments to stimulate the oropharyngeal swallow response are under research. OD matches the definition of a geriatric syndrome as it is highly prevalent among older people, is caused by multiple factors, is associated with several comorbidities and poor prognosis, and needs a multidimensional approach to be treated. OD should be given more importance and attention and thus be included in all standard screening protocols, treated, and regularly monitored to prevent its main complications. More research is needed to develop and standardize new treatments and management protocols for older patients with OD, which is a challenging mission for our societies. PMID:27785002

Evaluation of 5-year-old children with complete cleft lip and palate: Multicenter study. Part 2: Functional results.

PubMed

Dissaux, Caroline; Grollemund, Bruno; Bodin, Frédéric; Picard, Arnaud; Vazquez, Marie-Paule; Morand, Béatrice; James, Isabelle; Kauffmann, Isabelle; Bruant-Rodier, Catherine

2016-02-01

Cleft surgery is marked by all the controversies and the multiplication of protocols, as it has been shown by the Eurocleft study. The objective of this pilot study is to start a comparison and analyzing procedure between primary surgical protocols in French centers. Four French centers with different primary surgical protocols for cleft lip and palate repair, have accepted to be involved in this retrospective study. In each center, 20 consecutive patients with complete cleft lip and palate (10 UCLP, 10 BCLP per center), non syndromic, have been evaluated at a mean age of 5 [range, 4-6]. In this second part, maxillary growth and palatine morphology were assessed on clinical examination and on dental casts (Goslon score). Speech was also evaluated clinically (Borel-maisonny classification) and by Aerophonoscope. Veau-Wardill-Killner palatoplasty involves a higher rate of transversal maxillary deficiency and retromaxillary. The fistula rate is statistically lower with tibial periosteum graft hard palate closure but this technique seems to give retromaxillary. Malek and Talmant two-stage-palatoplasty techniques reach Goslon scores of 1 or 2. Considering speech, Sommerlad intravelar veloplasty got higher outcomes. Primary results. Extension to other centers required. The two-stage palatoplasty, including a Sommerlad intravelar veloplasty seems to have the less negative impact on maxillary growth, and to give good speech outcomes. Therapeutic study. Level III/retrospective multicenter comparative study. Copyright © 2015 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

Patient-centred screening for primary immunodeficiency: a multi-stage diagnostic protocol designed for non-immunologists

PubMed Central

de Vries, E

2006-01-01

Efficient early identification of primary immunodeficiency disease (PID) is important for prognosis, but is not an easy task for non-immunologists. The Clinical Working Party of the European Society for Immunodeficiencies (ESID) has composed a multi-stage diagnostic protocol that is based on expert opinion, in order to increase the awareness of PID among doctors working in different fields. The protocol starts from the clinical presentation of the patient; immunological skills are not needed for its use. The multi-stage design allows cost-effective screening for PID within the large pool of potential cases in all hospitals in the early phases, while more expensive tests are reserved for definitive classification in collaboration with an immunologist at a later stage. Although many PIDs present in childhood, others may present at any age. The protocols presented here are therefore aimed at both adult physicians and paediatricians. While designed for use throughout Europe, there will be national differences which may make modification of this generic algorithm necessary. PMID:16879238

Fuel switching in the electricity sector under the EU ETS: Review and prospective

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

Delarue, E.; Voorspools, K.; D'haeseleer, W.

2008-06-15

The European Union has implemented the European Union emission trading scheme (EU ETS) as an instrument to facilitate greenhouse gas (GHG) emission abatement stipulated in the Kyoto protocol. Empirical data show that in the early stages of the EU ETS, the value of a ton of CO{sub 2} has already led to emission abatement through switching from coal to gas in the European electric power sector. In the second part of this paper, an electricity generation simulation model is used to perform simulations on the switching behavior in both the first and the second trading periods of the EU ETS.more » In 2005, the reduction in GHG emissions in the electric power sector due to EU ETS is estimated close to 88 Mton. For the second trading period, a European Union allowance (EUA) price dependent GHG reduction curve has been determined. The obtained switching potential turns out to be significant, up to 300 Mton/year, at sufficiently high EUA prices.« less

Emissions of carbon tetrachloride from Europe

NASA Astrophysics Data System (ADS)

Graziosi, Francesco; Arduini, Jgor; Bonasoni, Paolo; Furlani, Francesco; Giostra, Umberto; Manning, Alistair J.; McCulloch, Archie; O'Doherty, Simon; Simmonds, Peter G.; Reimann, Stefan; Vollmer, Martin K.; Maione, Michela

2016-10-01

Carbon tetrachloride (CCl4) is a long-lived radiatively active compound with the ability to destroy stratospheric ozone. Due to its inclusion in the Montreal Protocol on Substances that Deplete the Ozone Layer (MP), the last two decades have seen a sharp decrease in its large-scale emissive use with a consequent decline in its atmospheric mole fractions. However, the MP restrictions do not apply to the use of carbon tetrachloride as feedstock for the production of other chemicals, implying the risk of fugitive emissions from the industry sector. The occurrence of such unintended emissions is suggested by a significant discrepancy between global emissions as derived from reported production and feedstock usage (bottom-up emissions), and those based on atmospheric observations (top-down emissions). In order to better constrain the atmospheric budget of carbon tetrachloride, several studies based on a combination of atmospheric observations and inverse modelling have been conducted in recent years in various regions of the world. This study is focused on the European scale and based on long-term high-frequency observations at three European sites, combined with a Bayesian inversion methodology. We estimated that average European emissions for 2006-2014 were 2.2 (± 0.8) Gg yr-1, with an average decreasing trend of 6.9 % per year. Our analysis identified France as the main source of emissions over the whole study period, with an average contribution to total European emissions of approximately 26 %. The inversion was also able to allow the localisation of emission "hot spots" in the domain, with major source areas in southern France, central England (UK) and Benelux (Belgium, the Netherlands, Luxembourg), where most industrial-scale production of basic organic chemicals is located. According to our results, European emissions correspond, on average, to 4.0 % of global emissions for 2006-2012. Together with other regional studies, our results allow a better constraint of the global budget of carbon tetrachloride and a better quantification of the gap between top-down and bottom-up estimates.

Unravelling current sexual care in chronic kidney disease: perspective of social workers.

PubMed

van Ek, Gaby F; Keurhorst, Dirry; Krouwel, Esmée M; Nicolai, Melianthe P J; Den Ouden, Marjolein E M; Elzevier, Henk W; Putter, Hein; Pelger, Rob C M; Den Oudsten, Brenda L

2018-03-01

Fifty to eighty percent of patients suffering from chronic kidney disease (CKD) experience a form of sexual dysfunction (SD), even after renal transplantation. Despite this, inquiring about SD is often not included in the daily practice of renal care providers. This paper explores the perspectives of renal social workers regarding sexual care for patients and evaluates their practice, attitude towards responsibility and knowledge of SD. A cross-sectional study was conducted using a 41-item online survey. Seventy-nine members of the Dutch Federation of Social Workers Nephrology. It was revealed that 60% of respondents discussed SD with a fifth of their patients. Frequency of discussion was associated with experience (p = 0.049), knowledge (p = 0.001), supplementary education (p = 0.006), and the availability of protocols on sexual care (p = 0.007). Main barriers towards discussing SD consisted of 'culture and religion' (51.9%), 'language and ethnicity' (49.4%), and 'presence of a third person' (45.6%). Sufficient knowledge of SD was present in 28% of respondents. The responsibility for discussion was 96% nephrologists and 81% social workers. This study provides evidence that a part of Dutch nephrology social workers do not provide sexual care regularly, due to insufficient experience and sexual knowledge, absence of privacy and protocols and barriers based on cultural diversity. According to the respondents the responsibility for this aspect of care should be multidisciplinary. Recommendations include a need for further education on the topic, private opportunities to discuss SD and multidisciplinary guidelines on sexual care. © 2017 European Dialysis and Transplant Nurses Association/European Renal Care Association.

Association Between Short-term Exposure to Ultrafine Particles and Mortality in Eight European Urban Areas.

PubMed

Stafoggia, Massimo; Schneider, Alexandra; Cyrys, Josef; Samoli, Evangelia; Andersen, Zorana Jovanovic; Bedada, Getahun Bero; Bellander, Tom; Cattani, Giorgio; Eleftheriadis, Konstantinos; Faustini, Annunziata; Hoffmann, Barbara; Jacquemin, Bénédicte; Katsouyanni, Klea; Massling, Andreas; Pekkanen, Juha; Perez, Noemi; Peters, Annette; Quass, Ulrich; Yli-Tuomi, Tarja; Forastiere, Francesco

2017-03-01

Epidemiologic evidence on the association between short-term exposure to ultrafine particles and mortality is weak, due to the lack of routine measurements of these particles and standardized multicenter studies. We investigated the relationship between ultrafine particles and particulate matter (PM) and daily mortality in eight European urban areas. We collected daily data on nonaccidental and cardiorespiratory mortality, particle number concentrations (as proxy for ultrafine particle number concentration), fine and coarse PM, gases and meteorologic parameters in eight urban areas of Finland, Sweden, Denmark, Germany, Italy, Spain, and Greece, between 1999 and 2013. We applied city-specific time-series Poisson regression models and pooled them with random-effects meta-analysis. We estimated a weak, delayed association between particle number concentration and nonaccidental mortality, with mortality increasing by approximately 0.35% per 10,000 particles/cm increases in particle number concentration occurring 5 to 7 days before death. A similar pattern was found for cause-specific mortality. Estimates decreased after adjustment for fine particles (PM2.5) or nitrogen dioxide (NO2). The stronger association found between particle number concentration and mortality in the warmer season (1.14% increase) became null after adjustment for other pollutants. We found weak evidence of an association between daily ultrafine particles and mortality. Further studies are required with standardized protocols for ultrafine particle data collection in multiple European cities over extended study periods.

Objectively Measured Physical Activity in European Adults: Cross-Sectional Findings from the Food4Me Study.

PubMed

Marsaux, Cyril F M; Celis-Morales, Carlos; Hoonhout, Jettie; Claassen, Arjan; Goris, Annelies; Forster, Hannah; Fallaize, Rosalind; Macready, Anna L; Navas-Carretero, Santiago; Kolossa, Silvia; Walsh, Marianne C; Lambrinou, Christina-Paulina; Manios, Yannis; Godlewska, Magdalena; Traczyk, Iwona; Lovegrove, Julie A; Martinez, J Alfredo; Daniel, Hannelore; Gibney, Mike; Mathers, John C; Saris, Wim H M

2016-01-01

Comparisons of objectively measured physical activity (PA) between residents of European countries measured concurrently with the same protocol are lacking. We aimed to compare PA between the seven European countries involved in the Food4Me Study, using accelerometer data collected remotely via the Internet. Of the 1607 participants recruited, 1287 (539 men and 748 women) provided at least 3 weekdays and 2 weekend days of valid accelerometer data (TracmorD) at baseline and were included in the present analyses. Men were significantly more active than women (physical activity level = 1.74 vs. 1.70, p < 0.001). Time spent in light PA and moderate PA differed significantly between countries but only for women. Adherence to the World Health Organization recommendation to accumulate at least 150 min of moderate-equivalent PA weekly was similar between countries for men (range: 54-65%) but differed significantly between countries for women (range: 26-49%). Prevalence estimates decreased substantially for men and women in all seven countries when PA guidelines were defined as achieving 30 min of moderate and vigorous PA per day. We were able to obtain valid accelerometer data in real time via the Internet from 80% of participants. Although our estimates are higher compared with data from Sweden, Norway, Portugal and the US, there is room for improvement in PA for all countries involved in the Food4Me Study.

Implementation of preventive mental health services for children of physically ill parents: experiences in seven European countries and health care systems.

PubMed

Kühne, Franziska; Haagen, Miriam; Baldus, Christiane; Diareme, Stavroula; Grether, Andrea; Schmitt, Florence; Stanescu, Dan; Stöckl, Margit; Thastum, Mikael; Möller, Birgit; Romer, Georg

2013-01-01

Parental physical disease is a family issue, but families' minor children are seldom considered. The current study analyzed experiences with implementation of counseling for families with physically ill parents and minor children during a European multisite pilot project. Implementation protocols of seven European partner centers collaborating in a joint research project were analyzed by Mayring's qualitative content analysis. Both an inductive approach and a deductive approach were chosen. Satisfaction of families and therapists was considered based on information from three partner centers. Satisfaction with counseling was rather high. Mentioned problems referred to aspects related to liaison partners, family-related aspects and physicians' concerns. Recommendations related to contacting families, liaising with other professions, implementing counseling together with a research project, and training. Results are integrated in the current dissemination literature. Successful implementation was mostly determined by aspects of interdisciplinary cooperation and communication, perceived relative advantage and organizational premises. With regard to this kind of innovative child-centered family mental health services, top-down and bottom-up implementation strategies should be combined, and strategies of maintenance and sustainability should be considered from the very beginning. Copyright © 2013 Elsevier Inc. All rights reserved.

Development of a core outcome set for medication review in older patients with multimorbidity and polypharmacy: a study protocol.

PubMed

Beuscart, Jean-Baptiste; Dalleur, Olivia; Boland, Benoit; Thevelin, Stefanie; Knol, Wilma; Cullinan, Shane; Schneider, Claudio; O'Mahony, Denis; Rodondi, Nicolas; Spinewine, Anne

2017-01-01

Medication review has been advocated to address the challenge of polypharmacy in older patients, yet there is no consensus on how best to evaluate its efficacy. Heterogeneity of outcomes reported in clinical trials can hinder the comparison of clinical trial findings in systematic reviews. Moreover, the outcomes that matter most to older patients might be under-reported or disregarded altogether. A core outcome set can address this issue as it defines a minimum set of outcomes that should be reported in all clinical trials in any particular field of research. As part of the European Commission-funded project, called OPtimising thERapy to prevent Avoidable hospital admissions in the Multimorbid elderly, this paper describes the methods used to develop a core outcome set for clinical trials of medication review in older patients with multimorbidity. The study was designed in several steps. First, a systematic review established which outcomes were measured in published and ongoing clinical trials of medication review in older patients. Second, we undertook semistructured interviews with older patients and carers aimed at identifying additional relevant outcomes. Then, a multilanguage European Delphi survey adapted to older patients was designed. The international Delphi survey was conducted with older patients, health care professionals, researchers, and clinical experts in geriatric pharmacotherapy to validate outcomes to be included in the core outcome set. Consensus meetings were conducted to validate the results. We present the method for developing a core outcome set for medication review in older patients with multimorbidity. This study protocol could be used as a basis to develop core outcome sets in other fields of geriatric research.

A fresh look at the freeze-all protocol: a SWOT analysis.

PubMed

Blockeel, Christophe; Drakopoulos, Panagiotis; Santos-Ribeiro, Samuel; Polyzos, Nikolaos P; Tournaye, Herman

2016-03-01

The 'freeze-all' strategy with the segmentation of IVF treatment, namely with the use of a GnRH antagonist protocol, GnRH agonist triggering, the elective cryopreservation of all embryos by vitrification and a frozen-thawed embryo transfer in a subsequent cycle, has become more popular. However, the approach still encounters drawbacks. In this opinion paper, a SWOT (strengths, weaknesses, opportunities and threats) analysis sheds light on the different aspects of this strategy. © The Author 2016. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Implementation of a more physiological plasma rich in growth factor (PRGF) protocol: Anticoagulant removal and reduction in activator concentration.

PubMed

Anitua, Eduardo; Prado, Roberto; Troya, María; Zalduendo, Mar; de la Fuente, María; Pino, Ander; Muruzabal, Francisco; Orive, Gorka

2016-07-01

Plasma rich in growth factors (PRGF) is a biological therapy that uses patient's own growth factors for promoting tissue regeneration. Given the current European regulatory framework in which anticoagulant solution in blood extraction tubes could be considered as a medicinal product, a new PRGF protocol has been developed. The actual protocol (PRGF-A) and the new one (PRGF-B) have been performed and compared under Good Laboratory Practices. PRGF-A protocol uses extraction tubes with 0.9 mL of trisodium citrate as anticoagulant and 50 μL of calcium chloride/mL PRGF to activate it. The PRGF-B reduces the amount of sodium citrate and calcium chloride to 0.4 mL and to 20 μL, respectively. Basic hematological parameters, platelet function, the scaffold obtaining process, growth factors content, and the biological effect were compared between both PRGF obtaining protocols. PRGF-B protocol led to a statistically significant higher enrichment and recovery of platelets regarding to the PRGF-A. Hypotonic stress response by platelets was significantly better in the new protocol. A statistically significant decrease in the basal platelet activation status of PRGF-B compared to PRGF-A was also observed. The duration of the lag phase in the platelet aggregation assay was statistically lower for the PRGF-B protocol. Both the clotting and the clot retraction time were significantly reduced in the B protocol. A higher growth factor concentration was detected in the plasma obtained using the PRGF-B protocol. The new PRGF obtaining protocol, with a reduction in the amount of anticoagulant and activator, has even improved the actual one.

Refining animal models in fracture research: seeking consensus in optimising both animal welfare and scientific validity for appropriate biomedical use

PubMed Central

Auer, Jorg A; Goodship, Allen; Arnoczky, Steven; Pearce, Simon; Price, Jill; Claes, Lutz; von Rechenberg, Brigitte; Hofmann-Amtenbrinck, Margarethe; Schneider, Erich; Müller-Terpitz, R; Thiele, F; Rippe, Klaus-Peter; Grainger, David W

2007-01-01

Background In an attempt to establish some consensus on the proper use and design of experimental animal models in musculoskeletal research, AOVET (the veterinary specialty group of the AO Foundation) in concert with the AO Research Institute (ARI), and the European Academy for the Study of Scientific and Technological Advance, convened a group of musculoskeletal researchers, veterinarians, legal experts, and ethicists to discuss, in a frank and open forum, the use of animals in musculoskeletal research. Methods The group narrowed the field to fracture research. The consensus opinion resulting from this workshop can be summarized as follows: Results & Conclusion Anaesthesia and pain management protocols for research animals should follow standard protocols applied in clinical work for the species involved. This will improve morbidity and mortality outcomes. A database should be established to facilitate selection of anaesthesia and pain management protocols for specific experimental surgical procedures and adopted as an International Standard (IS) according to animal species selected. A list of 10 golden rules and requirements for conduction of animal experiments in musculoskeletal research was drawn up comprising 1) Intelligent study designs to receive appropriate answers; 2) Minimal complication rates (5 to max. 10%); 3) Defined end-points for both welfare and scientific outputs analogous to quality assessment (QA) audit of protocols in GLP studies; 4) Sufficient details for materials and methods applied; 5) Potentially confounding variables (genetic background, seasonal, hormonal, size, histological, and biomechanical differences); 6) Post-operative management with emphasis on analgesia and follow-up examinations; 7) Study protocols to satisfy criteria established for a "justified animal study"; 8) Surgical expertise to conduct surgery on animals; 9) Pilot studies as a critical part of model validation and powering of the definitive study design; 10) Criteria for funding agencies to include requirements related to animal experiments as part of the overall scientific proposal review protocols. Such agencies are also encouraged to seriously consider and adopt the recommendations described here when awarding funds for specific projects. Specific new requirements and mandates related both to improving the welfare and scientific rigour of animal-based research models are urgently needed as part of international harmonization of standards. PMID:17678534

Development of Mechanical Engineering Curricula at the University of Minho

ERIC Educational Resources Information Center

Teixeira, Jose Carlos Fernandes; da Silva, Jaime Ferreira; Flores, Paulo

2007-01-01

The implementation of the Bologna protocol in the European Union has set new goals for the whole higher education system as: (a) a quality assessment for university courses; (b) a framework for the exchange of students and academics; and (c) an opportunity for changing the teaching/learning procedures and methodologies. Within the context, the…

Cognitive Behavioral Therapy for 4- to 7-Year-Old Children with Anxiety Disorders: A Randomized Clinical Trial

ERIC Educational Resources Information Center

Hirshfeld-Becker, Dina R.; Masek, Bruce; Henin, Aude; Blakely, Lauren Raezer; Pollock-Wurman, Rachel A.; McQuade, Julia; DePetrillo, Lillian; Briesch, Jacquelyn; Ollendick, Thomas H.; Rosenbaum, Jerrold F.; Biederman, Joseph

2010-01-01

Objective: To examine the efficacy of a developmentally appropriate parent-child cognitive behavioral therapy (CBT) protocol for anxiety disorders in children ages 4-7 years. Method: Design: Randomized wait-list controlled trial. Conduct: Sixty-four children (53% female, mean age 5.4 years, 80% European American) with anxiety disorders were…

Synchrotron Radiation Therapy from a Medical Physics point of view

NASA Astrophysics Data System (ADS)

Prezado, Y.; Adam, J. F.; Berkvens, P.; Martinez-Rovira, I.; Fois, G.; Thengumpallil, S.; Edouard, M.; Vautrin, M.; Deman, P.; Bräuer-Krisch, E.; Renier, M.; Elleaume, H.; Estève, F.; Bravin, A.

2010-07-01

Synchrotron radiation (SR) therapy is a promising alternative to treat brain tumors, whose management is limited due to the high morbidity of the surrounding healthy tissues. Several approaches are being explored by using SR at the European Synchrotron Radiation Facility (ESRF), where three techniques are under development Synchrotron Stereotactic Radiation Therapy (SSRT), Microbeam Radiation Therapy (MRT) and Minibeam Radiation Therapy (MBRT). The sucess of the preclinical studies on SSRT and MRT has paved the way to clinical trials currently in preparation at the ESRF. With this aim, different dosimetric aspects from both theoretical and experimental points of view have been assessed. In particular, the definition of safe irradiation protocols, the beam energy providing the best balance between tumor treatment and healthy tissue sparing in MRT and MBRT, the special dosimetric considerations for small field dosimetry, etc will be described. In addition, for the clinical trials, the definition of appropiate dosimetry protocols for patients according to the well established European Medical Physics recommendations will be discussed. Finally, the state of the art of the MBRT technical developments at the ESRF will be presented. In 2006 A. Dilmanian and collaborators proposed the use of thicker microbeams (0.36-0.68 mm). This new type of radiotherapy is the most recently implemented technique at the ESRF and it has been called MBRT. The main advantage of MBRT with respect to MRT is that it does not require high dose rates. Therefore it can be more easily applied and extended outside synchrotron sources in the future.

Validation of the custo screen 400 ambulatory blood pressure-monitoring device according to the European Society of Hypertension International Protocol revision 2010.

PubMed

Bramlage, Peter; Deutsch, Cornelia; Krüger, Ralf; Wolf, Andreas; Müller, Peter; Zwingers, Thomas; Beime, Beate; Mengden, Thomas

2014-01-01

The aim of the present study was to validate the custo screen 400 ambulatory blood pressure-monitoring (ABPM) device according to the 2010 International Protocol revision of the European Society of Hypertension (ESH-IP). The device can be used for ABPM for up to 72 hours. Systolic and diastolic blood pressure (SBP and DBP, respectively) were sequentially measured in 33 adult subjects (13 males and 20 females) and compared with a standard mercury sphygmomanometer (two observers). A total of 99 comparison pairs were obtained. The custo screen 400 met the requirements of parts 1 and 2 of the ESH-IP revision 2010. The mean difference between the device and reference sphygmomanometer readings was -0.5±4.5 mmHg for SBP and -0.1±3.3 mmHg for DBP. All but one measurement were within the absolute difference of 10 mmHg between the device and the observers for SBP and DBP. The number of absolute differences between the device and the observers within a range of 5 mmHg was 84 of 99 readings for SBP, and 93 of 99 readings for DBP. The custo screen 400 ABPM device met the requirements of the 2010 ESH-IP revision, and hence can be recommended for ABPM in adults. To our knowledge, the custo screen 400 is the first device to pass the revised ESH-IP 2010.

Validation of Transtek LS808-B for self/home measurement according to the European Society of Hypertension International Protocol revision 2010.

PubMed

Liu, Zhong Hua; Liu, Xian Yue; Wu, Wen Jun

2016-12-01

This study aimed to evaluate the accuracy of Transtek LS808-B according to the European Society of Hypertension International Protocol revision 2010 (ESH-IP2010). A total of 33 adult individuals (19 men and 14 women, mean age 46.8±15.8 years) were recruited; their systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured using the mercury sphygmomanometer and Transtek LS808-B. A total of 99 pairs of measurements were obtained from these 33 participants for comparison in two parts with three grading phases. All the validation requirements were fulfilled. The number of absolute difference between the tested device and the observers within 5, 10, and 15 mmHg was 73, 94, and 98 for SBP and 78, 94, and 99 for DBP, respectively. The mean±SD of the device-observer difference was 0.5±4.4 mmHg for SBP and 0.2±4.1 mmHg for DBP. The number of participants with two or three device-observer differences within 5 mmHg was 24 for SBP and 27 for DBP. In addition, two of the participants had no device-observer difference within 5 mmHg for SBP and one of the participants had the same for DBP. Transtek LS808-B has passed all phases of ESH-IP 2010, and hence can be recommended for self/home measurement in adult populations.

Validation of the blood pressure measurement device Erkameter 125 PRO according to the European Society of Hypertension International Protocol revision 2010.

PubMed

Beime, Beate; Deutsch, Cornelia; Krüger, Ralf; Zimmermann, Erik; Bramlage, Peter

2016-12-01

The aim of the present study was to validate the blood pressure (BP) measurement device Erkameter 125 PRO according to the International Protocol revision 2010 of the European Society of Hypertension (ESH-IP2). In 33 patients aged 32-79 years, BP measurements were performed alternately using the Erkameter 125 PRO and the reference mercury sphygmomanometer according to ESH-IP revision 2010. For the analysis, a total of 99 comparisons were included. All absolute differences between the test device and the reference were within 10 mmHg for systolic blood pressure (SBP), and all except one for diastolic blood pressure (DBP). A total of 93 out of 99 comparisons for SBP showed an absolute difference within 5 mmHg and 92 out of 99 for DBP. The mean±SD difference between the Erkameter 125 PRO and the standard reference was -0.5±3.5 mmHg for SBP and 0.5±3.5 mmHg for DBP. As to part 2 of ESH-IP 2010, all patients had a minimum of two out of three measurements within 5 mmHg difference for SBP and 31 out of 33 patients for DBP. The Erkameter 125 PRO fulfilled the requirements of parts 1 and 2 of the ESH-IP revision 2010 and can be recommended for office BP measurements in adults.

Validation of the custo screen 400 ambulatory blood pressure-monitoring device according to the European Society of Hypertension International Protocol revision 2010

PubMed Central

Bramlage, Peter; Deutsch, Cornelia; Krüger, Ralf; Wolf, Andreas; Müller, Peter; Zwingers, Thomas; Beime, Beate; Mengden, Thomas

2014-01-01

Objective The aim of the present study was to validate the custo screen 400 ambulatory blood pressure-monitoring (ABPM) device according to the 2010 International Protocol revision of the European Society of Hypertension (ESH-IP). The device can be used for ABPM for up to 72 hours. Materials and methods Systolic and diastolic blood pressure (SBP and DBP, respectively) were sequentially measured in 33 adult subjects (13 males and 20 females) and compared with a standard mercury sphygmomanometer (two observers). A total of 99 comparison pairs were obtained. Results The custo screen 400 met the requirements of parts 1 and 2 of the ESH-IP revision 2010. The mean difference between the device and reference sphygmomanometer readings was −0.5±4.5 mmHg for SBP and −0.1±3.3 mmHg for DBP. All but one measurement were within the absolute difference of 10 mmHg between the device and the observers for SBP and DBP. The number of absolute differences between the device and the observers within a range of 5 mmHg was 84 of 99 readings for SBP, and 93 of 99 readings for DBP. Conclusion The custo screen 400 ABPM device met the requirements of the 2010 ESH-IP revision, and hence can be recommended for ABPM in adults. To our knowledge, the custo screen 400 is the first device to pass the revised ESH-IP 2010. PMID:24868162

FRESH AIR: an implementation research project funded through Horizon 2020 exploring the prevention, diagnosis and treatment of chronic respiratory diseases in low-resource settings.

PubMed

Cragg, Liza; Williams, Siân; Chavannes, Niels H

2016-06-30

This protocol describes FRESH AIR, an implementation science project exploring how to improve the prevention, diagnosis and treatment of chronic lung diseases in contexts with limited healthcare resources. It consists of inter-related studies that take place in four countries that are part of the International Primary Care Respiratory Group's (IPCRG) global network: Uganda, the Kyrgyz Republic, Vietnam and Greece. The project has been funded by the European Commission Horizon 2020 research programme and runs from October 2015 until September 2018.

Comparison of methods for the quantification of the different carbon fractions in atmospheric aerosol samples

NASA Astrophysics Data System (ADS)

Nunes, Teresa; Mirante, Fátima; Almeida, Elza; Pio, Casimiro

2010-05-01

Atmospheric carbon consists of: organic carbon (OC, including various organic compounds), elemental carbon (EC, or black carbon [BC]/soot, a non-volatile/light-absorbing carbon), and a small quantity of carbonate carbon. Thermal/optical methods (TOM) have been widely used for quantifying total carbon (TC), OC, and EC in ambient and source particulate samples. Unfortunately, the different thermal evolution protocols in use can result in a wide elemental carbon-to-total carbon variation. Temperature evolution in thermal carbon analysis is critical to the allocation of carbon fractions. Another critical point in OC and EC quantification by TOM is the interference of carbonate carbon (CC) that could be present in the particulate samples, mainly in the coarse fraction of atmospheric aerosol. One of the methods used to minimize this interference consists on the use of a sample pre-treatment with acid to eliminate CC prior to thermal analysis (Chow et al., 2001; Pio et al., 1994). In Europe, there is currently no standard procedure for determining the carbonaceous aerosol fraction, which implies that data from different laboratories at various sites are of unknown accuracy and cannot be considered comparable. In the framework of the EU-project EUSAAR, a comprehensive study has been carried out to identify the causes of differences in the EC measured using different thermal evolution protocols. From this study an optimised protocol, the EUSAAR-2 protocol, was defined (Cavali et al., 2009). During the last two decades thousands of aerosol samples have been taken over quartz filters at urban, industrial, rural and background sites, and also from plume forest fires and biomass burning in a domestic closed stove. These samples were analysed for OC and EC, by a TOM, similar to that in use in the IMPROVE network (Pio et al., 2007). More recently we reduced the number of steps in thermal evolution protocols, without significant repercussions in the OC/EC quantifications. In order to evaluate the possibility of continue using, for trend analysis, the historical data set, we performed an inter-comparison between our method and an adaptation of EUSAAR-2 protocol, taking into account that this last protocol will possibly be recommended for analysing carbonaceous aerosols at European sites. In this inter-comparison we tested different types of samples (PM2,5, PM2,5-10, PM10) with large spectra of carbon loadings, with and without pre-treatment acidification. For a reduced number of samples, five replicates of each one were analysed by each method for statistical purposes. The inter-comparison study revealed that when the sample analysis were performed in similar room conditions, the two thermo-optic methods give similar results for TC, OC and EC, without significant differences at a 95% confidence level. The correlation between the methods, DAO and EUSAAR-2 for EC is smaller than for TC and OC, although showing a coefficient correlation over 0,95, with a slope close to one. For samples performed in different periods, room temperatures seem to have a significant effect over OC quantification. The sample pre-treatment with HCl fumigation tends to decrease TC quantification, mainly due to the more volatile organic fraction release during the first heating step. For a set of 20 domestic biomass burning samples analyzed by the DAO method we observed an average decrease in TC quantification of 3,7 % in relation to non-acidified samples, even though this decrease is accompanied by an average increase in the less volatile organic fraction. The indirect measurement of carbon carbonate, usually a minor carbon component in the carbonaceous aerosol, based on the difference between TC measured by TOM of acidified and non-acidified samples is not a robust measurement, considering the biases affecting his quantification. The present study show that the two thermo-optic temperature program used for OC and EC quantification give similar results, and if in the future the EUSAAR-2 protocol will be adopted the past measurement of carbonaceous fractions can be used for trend analysis. However this study demonstrates that the temperature control during post-sampling handling is a critical point in total OC and TC quantification that must be assigned in the new European protocol. References: Cavali et al., 2009, AMTD 2, 2321-2345, 2009 Chow et al., 2001, Aerosol. Sci. Technol., 34, 23-34, 2001. Pio et al., 1994, Proceedings of the Sixth European Symposium on Physico-Chemical Behavior of Atmospheric Pollutants. Report EUR 15609/2 EN, pp. 706-711. Pio et al, 2007, J. Geophys. Res. 112, D23S02 Acknowledgement: This work was funded by the Portuguese Science Foundation through the projects POCI/AMB/60267/2004 and PTDC/AMB/65706/2006 (BIOEMI). F. Mirante acknowledges the PhD grant SFRH/BD/45473/2008.

The making of a pan-European organ transplant registry.

PubMed

Smits, Jacqueline M; Niesing, Jan; Breidenbach, Thomas; Collett, Dave

2013-03-01

A European patient registry to track the outcomes of organ transplant recipients does not exist. As knowledge gleaned from large registries has already led to the creation of standards of care that gained widespread support from patients and healthcare providers, the European Union initiated a project that would enable the creation of a European Registry linking currently existing national databases. This report contains a description of all functional, technical, and legal prerequisites, which upon fulfillment should allow for the seamless sharing of national longitudinal data across temporal, geographical, and subspecialty boundaries. To create a platform that can effortlessly link multiple databases and maintain the integrity of the existing national databases crucial elements were described during the project. These elements are: (i) use of a common dictionary, (ii) use of a common database and refined data uploading technology, (iii) use of standard methodology to allow uniform protocol driven and meaningful long-term follow-up analyses, (iv) use of a quality assurance mechanism to guarantee completeness and accuracy of the data collected, and (v) establishment of a solid legal framework that allows for safe data exchange. © 2012 The Authors Transplant International © 2012 European Society for Organ Transplantation. Published by Blackwell Publishing Ltd.

European conformation and fat scores have no relationship with eating quality.

PubMed

Bonny, S P F; Pethick, D W; Legrand, I; Wierzbicki, J; Allen, P; Farmer, L J; Polkinghorne, R J; Hocquette, J-F; Gardner, G E

2016-06-01

European conformation and fat grades are a major factor determining carcass value throughout Europe. The relationships between these scores and sensory scores were investigated. A total of 3786 French, Polish and Irish consumers evaluated steaks, grilled to a medium doneness, according to protocols of the ���Meat Standards Australia��� system, from 18 muscles representing 455 local, commercial cattle from commercial abattoirs. A mixed linear effects model was used for the analysis. There was a negative relationship between juiciness and European conformation score. For the other sensory scores, a maximum of three muscles out of a possible 18 demonstrated negative effects of conformation score on sensory scores. There was a positive effect of European fat score on three individual muscles. However, this was accounted for by marbling score. Thus, while the European carcass classification system may indicate yield, it has no consistent relationship with sensory scores at a carcass level that is suitable for use in a commercial system. The industry should consider using an additional system related to eating quality to aid in the determination of the monetary value of carcasses, rewarding eating quality in addition to yield.

Standardized food images: A photographing protocol and image database.

PubMed

Charbonnier, Lisette; van Meer, Floor; van der Laan, Laura N; Viergever, Max A; Smeets, Paul A M

2016-01-01

The regulation of food intake has gained much research interest because of the current obesity epidemic. For research purposes, food images are a good and convenient alternative for real food because many dietary decisions are made based on the sight of foods. Food pictures are assumed to elicit anticipatory responses similar to real foods because of learned associations between visual food characteristics and post-ingestive consequences. In contemporary food science, a wide variety of images are used which introduces between-study variability and hampers comparison and meta-analysis of results. Therefore, we created an easy-to-use photographing protocol which enables researchers to generate high resolution food images appropriate for their study objective and population. In addition, we provide a high quality standardized picture set which was characterized in seven European countries. With the use of this photographing protocol a large number of food images were created. Of these images, 80 were selected based on their recognizability in Scotland, Greece and The Netherlands. We collected image characteristics such as liking, perceived calories and/or perceived healthiness ratings from 449 adults and 191 children. The majority of the foods were recognized and liked at all sites. The differences in liking ratings, perceived calories and perceived healthiness between sites were minimal. Furthermore, perceived caloric content and healthiness ratings correlated strongly (r ≥ 0.8) with actual caloric content in both adults and children. The photographing protocol as well as the images and the data are freely available for research use on http://nutritionalneuroscience.eu/. By providing the research community with standardized images and the tools to create their own, comparability between studies will be improved and a head-start is made for a world-wide standardized food image database. Copyright © 2015 Elsevier Ltd. All rights reserved.

Access to timely formal dementia care in Europe: protocol of the Actifcare (ACcess to Timely Formal Care) study.

PubMed

Kerpershoek, Liselot; de Vugt, Marjolein; Wolfs, Claire; Jelley, Hannah; Orrell, Martin; Woods, Bob; Stephan, Astrid; Bieber, Anja; Meyer, Gabriele; Engedal, Knut; Selbaek, Geir; Handels, Ron; Wimo, Anders; Hopper, Louise; Irving, Kate; Marques, Maria; Gonçalves-Pereira, Manuel; Portolani, Elisa; Zanetti, Orazio; Verhey, Frans

2016-08-23

Previous findings indicate that people with dementia and their informal carers experience difficulties accessing and using formal care services due to a mismatch between needs and service use. This mismatch causes overall dissatisfaction and is a waste of the scarce financial care resources. This article presents the background and methods of the Actifcare (ACcess to Timely Formal Care) project. This is a European study aiming at best-practice development in finding timely access to formal care for community-dwelling people with dementia and their informal carers. There are five main objectives: 1) Explore predisposing and enabling factors associated with the use of formal care, 2) Explore the association between the use of formal care, needs and quality of life and 3) Compare these across European countries, 4) Understand the costs and consequences of formal care services utilization in people with unmet needs, 5) Determine the major costs and quality of life drivers and their relationship with formal care services across European countries. In a longitudinal cohort study conducted in eight European countries approximately 450 people with dementia and informal carers will be assessed three times in 1 year (baseline, 6 and 12 months). In this year we will closely monitor the process of finding access to formal care. Data on service use, quality of life and needs will be collected. The results of Actifcare are expected to reveal best-practices in organizing formal care. Knowledge about enabling and predisposing factors regarding access to care services, as well as its costs and consequences, can advance the state of the art in health systems research into pathways to dementia care, in order to benefit people with dementia and their informal carers.

Transatlantic Comparison of CT Radiation Doses in the Era of Radiation Dose-Tracking Software.

PubMed

Parakh, Anushri; Euler, Andre; Szucs-Farkas, Zsolt; Schindera, Sebastian T

2017-12-01

The purpose of this study is to compare diagnostic reference levels from a local European CT dose registry, using radiation-tracking software from a large patient sample, with preexisting European and North American diagnostic reference levels. Data (n = 43,761 CT scans obtained over the course of 2 years) for the European local CT dose registry were obtained from eight CT scanners at six institutions. Means, medians, and interquartile ranges of volumetric CT dose index (CTDI vol ), dose-length product (DLP), size-specific dose estimate, and effective dose values for CT examinations of the head, paranasal sinuses, thorax, pulmonary angiogram, abdomen-pelvis, renal-colic, thorax-abdomen-pelvis, and thoracoabdominal angiogram were obtained using radiation-tracking software. Metrics from this registry were compared with diagnostic reference levels from Canada and California (published in 2015), the American College of Radiology (ACR) dose index registry (2015), and national diagnostic reference levels from local CT dose registries in Switzerland (2010), the United Kingdom (2011), and Portugal (2015). Our local registry had a lower 75th percentile CTDI vol for all protocols than did the individual internationally sourced data. Compared with our study, the ACR dose index registry had higher 75th percentile CTDI vol values by 55% for head, 240% for thorax, 28% for abdomen-pelvis, 42% for thorax-abdomen-pelvis, 128% for pulmonary angiogram, 138% for renal-colic, and 58% for paranasal sinus studies. Our local registry had lower diagnostic reference level values than did existing European and North American diagnostic reference levels. Automated radiation-tracking software could be used to establish and update existing diagnostic reference levels because they are capable of analyzing large datasets meaningfully.

The EURECA telecommanding chain: Experience with packet telecommand and telemetry systems

NASA Technical Reports Server (NTRS)

Mueller, C.; Bater, R.; Sorensen, E. M.

1993-01-01

The European Retrieval Carrier (EURECA) was launched on its first flight on the 31st July 1992 by the Space Shuttle Atlantis. EURECA is characterized by several new on-board features, most notable Packet Telemetry and a partial implementation of Packet Telecommanding using an early version of the Command Operation Procedure (COP-1) protocol. EURECA has also very low contact time with its Ground Station, with a consequent high number of out-of-visibility onboard operations. This paper concentrates on the implementation and operational experience with the COP-1 Protocol and the effect the short ground contact time has on the design of the Commanding System. Another interesting feature is that the COP-1 is implemented at the control center rather than at the ground station. The COP-1 protocol also successfully supported the mission during the launch where commands were sent via NASCOM and the Shuttle.

Clinical Neuropathology Views - 2/2016: Digital networking in European neuropathology: An initiative to facilitate truly interactive consultations.

PubMed

Idoate, Miguel A; García-Rojo, Marcial

2016-01-01

Digital technology is progressively changing our vision of the practice of neuropathology. There are a number of facts that support the introduction of digital neuropathology. With the development of wholeslide imaging (WSI) systems the difficulties involved in implementing a neuropathology network have been solved. A relevant difficulty has been image standardization, but an open digital image communication protocol defined by the Digital Imaging and Communications in Medicine (DICOM) standard is already a reality. The neuropathology network should be established in Europe because it is the expected geographic context for relationships among European neuropathologists. There are several limitations in the implementation of a digital neuropathology consultancy network such as financial support, operational costs, legal issues, and technical assistance of clients. All of these items have been considered and should be solved before implementing the proposal. Finally, the authors conclude that a European digital neuropathology network should be created for patients' benefit.

[Rules and regulations applying to incidents in radiotherapy].

PubMed

Lohr, F; Baus, W; Vorwerk, H; Schlömp, B; André, L; Georg, D; Hodapp, N

2012-07-01

Radiotherapy is an essential and reliable element of the treatment armamentarium in oncology. Numerous rules, regulations, and protocols minimize the associated risks. It can, however, never be excluded that errors in the treatment delivery chain result in inadequate tumor doses or unnecessary damage to organs at risk. A legal framework governs the management of such incidents. The most important European and North American regulations are reported. Various directives issued by the European Union are differently implemented nationally. This applies particularly to the characterization of incidents that must be reported to authorities. Reporting thresholds, audit systems, and the extent of the integration of voluntary reporting systems vary. Radiotherapy incidents are dealt with differently on an international level. Changes are to be expected based on the European Basic Safety Standards Directive that is currently being prepared and will have to be implemented nationally in due course.

New Tools to Search for Data in the European Space Agency's Planetary Science Archive

NASA Astrophysics Data System (ADS)

Grotheer, E.; Macfarlane, A. J.; Rios, C.; Arviset, C.; Heather, D.; Fraga, D.; Vallejo, F.; De Marchi, G.; Barbarisi, I.; Saiz, J.; Barthelemy, M.; Docasal, R.; Martinez, S.; Besse, S.; Lim, T.

2016-12-01

The European Space Agency's (ESA) Planetary Science Archive (PSA), which can be accessed at http://archives.esac.esa.int/psa, provides public access to the archived data of Europe's missions to our neighboring planets. These datasets are compliant with the Planetary Data System (PDS) standards. Recently, a new interface has been released, which includes upgrades to make PDS4 data available from newer missions such as ExoMars and BepiColombo. Additionally, the PSA development team has been working to ensure that the legacy PDS3 data will be more easily accessible via the new interface as well. In addition to a new querying interface, the new PSA also allows access via the EPN-TAP and PDAP protocols. This makes the PSA data sets compatible with other archive-related tools and projects, such as the Virtual European Solar and Planetary Access (VESPA) project for creating a virtual observatory.

PRIMARY IMMUNE DEFICIENCY TREATMENT CONSORTIUM (PIDTC) UPDATE

PubMed Central

Griffith, Linda M.; Cowan, Morton J.; Notarangelo, Luigi D.; Kohn, Donald B.; Puck, Jennifer M.; Shearer, William T.; Burroughs, Lauri M.; Torgerson, Troy R.; Decaluwe, Hélène; Haddad, Elie

2016-01-01

The Primary Immune Deficiency Treatment Consortium (PIDTC) is a collaboration of 41 North American centers studying therapy for rare primary immune deficiency diseases (PID) including Severe Combined Immune Deficiency (SCID), Wiskott-Aldrich syndrome (WAS) and chronic granulomatous disease (CGD). An additional 3 European centers have partnered with the PIDTC to study CGD. Natural history protocols of the PIDTC analyze outcomes of treatment for rare PID in multicenter longitudinal retrospective, prospective and cross-sectional studies. Since 2009, participating centers have enrolled over 800 subjects on PIDTC protocols for SCID, and enrollment on the studies in WAS and CGD is underway. Four pilot projects have been funded and 12 junior investigators have received fellowship awards. Important publications of the consortium describe outcomes of hematopoietic cell transplantation (HCT) for SCID during 2000–2009, diagnostic criteria for SCID, and the pilot project of newborn screening (NBS) for SCID in the Navajo Nation. The PIDTC Annual Scientific Workshops provide an opportunity to strengthen collaborations with junior investigators, patient advocacy groups and international colleagues. Funded by the NIAID and ORDR, NCATS, the PIDTC has recently received renewal for another 5 years. Here, we review accomplishments of the group, projects underway, highlights of recent workshops and challenges for the future. PMID:27262745

Nasal potential difference measurements in diagnosis of cystic fibrosis: an international survey.

PubMed

Naehrlich, Lutz; Ballmann, Manfred; Davies, Jane; Derichs, Nico; Gonska, Tanja; Hjelte, Lena; van Konigsbruggen-Rietschel, Silke; Leal, Teresinha; Melotti, Paola; Middleton, Peter; Tümmler, Burkhard; Vermeulen, Francois; Wilschanski, Michael

2014-01-01

The role of nasal potential difference (NPD) measurement as a diagnostic test for cystic fibrosis (CF) is a subject of global controversy because of the lack of validation studies, clear reference values, and standardized protocols for diagnostic NPD. To determine diagnostic NPD frequency, protocols, interpretation, and rater agreement, we surveyed the 18 NPD centres of the European Cystic Fibrosis Society Diagnostic Network Working Group. Fifteen centres reported performing 373 diagnostic NPDs in 2012. Most use the CFF-TDN-SOP (67%) and the chloride-free + isoproterenol response of the side with the largest response (47%) as diagnostic criteria and use centre-specific reference ranges. Rater agreement for five NPD tracings - in general - was good, but poor in tracings with different responses between the two nostrils. NPD is frequently used as a diagnostic and research tool for CF. Performance is highly standardized, centre-specific reference ranges are established, and rater agreement - in general - is good. Centre-independent diagnostic criteria and reference ranges must be defined by multicentre validation studies to improve standardized interpretation for diagnostic use. © 2013.

Recommended Implementation of Arterial Spin Labeled Perfusion MRI for Clinical Applications: A consensus of the ISMRM Perfusion Study Group and the European Consortium for ASL in Dementia

PubMed Central

Alsop, David C.; Detre, John A.; Golay, Xavier; Günther, Matthias; Hendrikse, Jeroen; Hernandez-Garcia, Luis; Lu, Hanzhang; MacIntosh, Bradley J.; Parkes, Laura M.; Smits, Marion; van Osch, Matthias J. P.; Wang, Danny JJ; Wong, Eric C.; Zaharchuk, Greg

2014-01-01

This article provides a summary statement of recommended implementations of arterial spin labeling (ASL) for clinical applications. It is a consensus of the ISMRM Perfusion Study Group and the European ‘ASL in Dementia’ consortium, both of whom met to reach this consensus in October 2012 in Amsterdam. Although ASL continues to undergo rapid technical development, we believe that current ASL methods are robust and ready to provide useful clinical information, and that a consensus statement on recommended implementations will help the clinical community to adopt a standardized approach. In this article we describe the major considerations and tradeoffs in implementing an ASL protocol, and provide specific recommendations for a standard approach. Our conclusions are that, as an optimal default implementation we recommend: pseudo-continuous labeling, background suppression, a segmented 3D readout without vascular crushing gradients, and calculation and presentation of both label/control difference images and cerebral blood flow in absolute units using a simplified model. PMID:24715426

The effect of cone beam CT (CBCT) on therapeutic decision-making in endodontics.

PubMed

Mota de Almeida, F J; Knutsson, K; Flygare, L

2014-01-01

The aim was to assess to what extent cone beam CT (CBCT) used in accordance with current European Commission guidelines in a normal clinical setting has an impact on therapeutic decisions in a population referred for endodontic problems. The study includes data of consecutively examined patients collected from October 2011 to December 2012. From 2 different endodontic specialist clinics, 57 patients were referred for a CBCT examination using criteria in accordance with current European guidelines. The CBCT examinations were performed using similar equipment and standardized among clinics. After a thorough clinical examination, but before CBCT, the examiner made a preliminary therapy plan which was recorded. After the CBCT examination, the same examiner made a new therapy plan. Therapy plans both before and after the CBCT examination were plotted for 53 patients and 81 teeth. As four patients had incomplete protocols, they were not included in the final analysis. 4% of the patients referred to endodontic clinics during the study period were examined with CBCT. The most frequent reason for referral to CBCT examination was to differentiate pathology from normal anatomy, this was the case in 24 patients (45% of the cases). The primary outcome was therapy plan changes that could be attributed to CBCT examination. There were changes in 28 patients (53%). CBCT has a significant impact on therapeutic decision efficacy in endodontics when used in concordance with the current European Commission guidelines.

An evaluation of different steam disinfection protocols for cystic fibrosis nebulizers.

PubMed

Hohenwarter, K; Prammer, W; Aichinger, W; Reychler, G

2016-01-01

Contamination is a key element in cystic fibrosis. For this reason, nebulizer hygiene is an important, but complex and time-consuming task for cystic fibrosis patients. The aim of this study was to compare different steam disinfection and drying protocols. One hundred nebulizer parts were inoculated with cystic fibrosis-related bacteria in high concentrations (Burkholderia multivorans 3.9 × 10(10)/ml, Staphylococcus aureus 8.9 × 10(8/)ml and Pseudomonas aeruginosa 2.1 × 10(9)/ml). Tubes with Mycobacterium abscessus complex were additionally tested. Six steam disinfectors were compared. Different methods of drying were examined. All tested bacteria were efficiently killed by the different steam disinfectors tested. The risk of contamination depended on the method of drying. Steam disinfection is a safe disinfection method. It is better to leave the nebulizers wet after steam disinfection than to manipulate them by active drying, which seems to be a source of recontamination. Copyright © 2015 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.

The expansion and performance of national newborn screening programmes for cystic fibrosis in Europe.

PubMed

Barben, Jürg; Castellani, Carlo; Dankert-Roelse, Jeannette; Gartner, Silvia; Kashirskaya, Nataliya; Linnane, Barry; Mayell, Sarah; Munck, Anne; Sands, Dorota; Sommerburg, Olaf; Pybus, Simon; Winters, Victoria; Southern, Kevin W

2017-03-01

Newborn screening (NBS) for cystic fibrosis (CF) is a well-established public health strategy with international standards. The aim of this study was to provide an update on NBS for CF in Europe and assess performance against the standards. Questionnaires were sent to key workers in each European country. In 2016, there were 17 national programmes, 4 countries with regional programmes and 25 countries not screening in Europe. All national programmes employed different protocols, with IRT-DNA the most common strategy. Five countries were not using DNA analysis. In addition, the processing and structure of programmes varied considerably. Most programmes were achieving the ECFS standards with respect to timeliness, but were less successful with respect to sensitivity and specificity. There has been a steady increase in national CF NBS programmes across Europe with variable strategies and outcomes that reflect the different approaches. Copyright © 2016 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.

Review of oil and HNS accidental spills in Europe: identifying major environmental monitoring gaps and drawing priorities.

PubMed

Neuparth, T; Moreira, S M; Santos, M M; Reis-Henriques, M A

2012-06-01

The European Atlantic area has been the scene of a number of extensive shipping incidents with immediate and potential long-term impacts to marine ecosystems. The occurrence of accidental spills at sea requires an effective response that must include a well executed monitoring programme to assess the environmental contamination and damage of the affected marine habitats. Despite a number of conventions and protocols developed by international and national authorities that focused on the preparedness and response to oil and HNS spills, much remains to be done, particularly in relation to the effectiveness of the environmental monitoring programmes implemented after oil and HNS spills. Hence, the present study reviews the status of the environmental monitoring programmes established following the major spill incidents over the last years in European waters, aiming at identifying the key monitoring gaps and drawing priorities for an effective environmental monitoring of accidental spills. Copyright © 2012 Elsevier Ltd. All rights reserved.

Multiplex Droplet Digital PCR Protocols for Quantification of GM Maize Events.

PubMed

Dobnik, David; Spilsberg, Bjørn; Bogožalec Košir, Alexandra; Štebih, Dejan; Morisset, Dany; Holst-Jensen, Arne; Žel, Jana

2018-01-01

The standard-curve based simplex quantitative polymerase chain reaction (qPCR) has been the gold standard for DNA target quantification for more than a decade. The large and growing number of individual analyses needed to test for genetically modified organisms (GMOs) is reducing the cost-effectiveness of qPCR. Droplet digital PCR (ddPCR) enables absolute quantification without standard curves, avoids the amplification efficiency bias observed with qPCR, allows more accurate estimations at low target copy numbers and, in combination with multiplexing, significantly improves cost efficiency. Here we describe two protocols for multiplex quantification of GM maize events: (1) nondiscriminating, with multiplex quantification of targets as a group (12 GM maize lines) and (2) discriminating, with multiplex quantification of individual targets (events). The first enables the quantification of twelve European Union authorized GM maize events as a group with only two assays, but does not permit determination of the individual events present. The second protocol enables the quantification of four individual targets (three GM events and one endogene) in a single reaction. Both protocols can be modified for quantification of any other DNA target.

Evaluation of Aspergillus PCR protocols for testing serum specimens.

PubMed

White, P Lewis; Mengoli, Carlo; Bretagne, Stéphane; Cuenca-Estrella, Manuel; Finnstrom, Niklas; Klingspor, Lena; Melchers, Willem J G; McCulloch, Elaine; Barnes, Rosemary A; Donnelly, J Peter; Loeffler, Juergen

2011-11-01

A panel of human serum samples spiked with various amounts of Aspergillus fumigatus genomic DNA was distributed to 23 centers within the European Aspergillus PCR Initiative to determine analytical performance of PCR. Information regarding specific methodological components and PCR performance was requested. The information provided was made anonymous, and meta-regression analysis was performed to determine any procedural factors that significantly altered PCR performance. Ninety-seven percent of protocols were able to detect a threshold of 10 genomes/ml on at least one occasion, with 83% of protocols reproducibly detecting this concentration. Sensitivity and specificity were 86.1% and 93.6%, respectively. Positive associations between sensitivity and the use of larger sample volumes, an internal control PCR, and PCR targeting the internal transcribed spacer (ITS) region were shown. Negative associations between sensitivity and the use of larger elution volumes (≥100 μl) and PCR targeting the mitochondrial genes were demonstrated. Most Aspergillus PCR protocols used to test serum generate satisfactory analytical performance. Testing serum requires less standardization, and the specific recommendations shown in this article will only improve performance.

Evaluation of Aspergillus PCR Protocols for Testing Serum Specimens▿†

PubMed Central

White, P. Lewis; Mengoli, Carlo; Bretagne, Stéphane; Cuenca-Estrella, Manuel; Finnstrom, Niklas; Klingspor, Lena; Melchers, Willem J. G.; McCulloch, Elaine; Barnes, Rosemary A.; Donnelly, J. Peter; Loeffler, Juergen

2011-01-01

A panel of human serum samples spiked with various amounts of Aspergillus fumigatus genomic DNA was distributed to 23 centers within the European Aspergillus PCR Initiative to determine analytical performance of PCR. Information regarding specific methodological components and PCR performance was requested. The information provided was made anonymous, and meta-regression analysis was performed to determine any procedural factors that significantly altered PCR performance. Ninety-seven percent of protocols were able to detect a threshold of 10 genomes/ml on at least one occasion, with 83% of protocols reproducibly detecting this concentration. Sensitivity and specificity were 86.1% and 93.6%, respectively. Positive associations between sensitivity and the use of larger sample volumes, an internal control PCR, and PCR targeting the internal transcribed spacer (ITS) region were shown. Negative associations between sensitivity and the use of larger elution volumes (≥100 μl) and PCR targeting the mitochondrial genes were demonstrated. Most Aspergillus PCR protocols used to test serum generate satisfactory analytical performance. Testing serum requires less standardization, and the specific recommendations shown in this article will only improve performance. PMID:21940479

Standardised studies on Molar Incisor Hypomineralisation (MIH) and Hypomineralised Second Primary Molars (HSPM): a need.

PubMed

Elfrink, M E C; Ghanim, A; Manton, D J; Weerheijm, K L

2015-06-01

In November 2014, a review of literature concerning prevalence data of Molar Incisor Hypomineralisation (MIH) and Hypomineralised Second Primary Molars (HSPM) was performed. A search of PubMed online databases was conducted for relevant articles published until November 2014. The reference lists of all retrieved articles were hand-searched. Studies were included after assessing the eligibility of the full-text article. Out of 1078 manuscripts, a total of 157 English written publications were selected based on title and abstract. Of these 157, 60 were included in the study and allocated as 52 MIH and 5 HSPM, and 3 for both MIH and HSPM. These studies utilised the European Academy of Paediatric Dentistry judgment criteria, the modified index of developmental defects of enamel (mDDE) and self-devised criteria, and demonstrated a wide variation in the reported prevalence (MIH 2.9-44 %; HSPM 0-21.8 %). Most values mentioned were representative for specific areas. More studies were performed in cities compared with rural areas. A great variation was found in calibration methods, number of participants, number of examiners and research protocols between the studies. The majority of the prevalence studies also investigated possible aetiological factors. To compare MIH and HSPM prevalence and or aetiological data around the world, standardisation of such studies seems essential. Standardisation of the research protocol should include a clearly described sample of children (minimum number of 300 for prevalence and 1000 for aetiology studies) and use of the same calibration sets and methods whereas aetiological studies need to be prospective in nature. A standardised protocol for future MIH and HSPM prevalence and aetiology studies is recommended.

Prevalence of refractive errors in the European adult population: the Gutenberg Health Study (GHS).

PubMed

Wolfram, Christian; Höhn, René; Kottler, Ulrike; Wild, Philipp; Blettner, Maria; Bühren, Jens; Pfeiffer, Norbert; Mirshahi, Alireza

2014-07-01

To study the distribution of refractive errors among adults of European descent. Population-based eye study in Germany with 15010 participants aged 35-74 years. The study participants underwent a detailed ophthalmic examination according to a standardised protocol. Refractive error was determined by an automatic refraction device (Humphrey HARK 599) without cycloplegia. Definitions for the analysis were myopia <-0.5 dioptres (D), hyperopia >+0.5 D, astigmatism >0.5 cylinder D and anisometropia >1.0 D difference in the spherical equivalent between the eyes. Exclusion criterion was previous cataract or refractive surgery. 13959 subjects were eligible. Refractive errors ranged from -21.5 to +13.88 D. Myopia was present in 35.1% of this study sample, hyperopia in 31.8%, astigmatism in 32.3% and anisometropia in 13.5%. The prevalence of myopia decreased, while the prevalence of hyperopia, astigmatism and anisometropia increased with age. 3.5% of the study sample had no refractive correction for their ametropia. Refractive errors affect the majority of the population. The Gutenberg Health Study sample contains more myopes than other study cohorts in adult populations. Our findings do not support the hypothesis of a generally lower prevalence of myopia among adults in Europe as compared with East Asia.

Validation of the TONOPORT VI ambulatory blood pressure monitor in adults according to the European Society of Hypertension International Protocol revision 2010.

PubMed

Abou-Dakn, M; Döhmen, C; Wenzel, S

2017-02-01

The present study aims to examine the performance of the TONOPORT VI ambulatory blood pressure (BP) monitor in the inflation and deflation measurement methods, according to the European Society of Hypertension International Protocol revision 2010 (ESH-IP 2010). Systolic and diastolic blood pressures (SBP and DBP, respectively) of 33 subjects (23 female, 10 male) were sequentially measured and compared with reference measurements obtained by two observers using a standard mercury sphygmomanometer. The subjects were selected according to the recruitment instructions of the ESH-IP 2010. Three comparative readings were performed per subject. Among the 99 readings in the inflation measurement method were 92/94 (SBP/DBP) with differences ⩽5, 97/99 ⩽10 and 98/99 ⩽15 mm Hg. All of the 33 subjects had at least 2 out of 3 comparative readings with differences ⩽5 mm Hg and 0/0 of the subjects had no reading ⩽15 mm Hg. The validation of the deflation measurement method resulted in differences where 93/91 were ⩽5, 98/98 were ⩽10, and 99/99 were ⩽15 mm Hg. Thirty-two of the 33 subjects had at least 2 out of 3 comparative readings ⩽5 mm Hg and 0/0 of the subjects had no reading ⩽15 mm Hg. In conclusion, the TONOPORT VI, respectively, in the inflation and deflation measurement methods met all requirements of Part 1 and 2 of the ESH-IP 2010. Based on the study results, the TONOPORT VI can be recommended for BP measurements in adults.

Lack of validation of the Dixtal (DX 2020) upper arm blood pressure monitor, in oscillometric mode, for clinical use in an intensive care unit, according to the European Society of Hypertension-International Protocol revision 2010.

PubMed

Gothardo, Ana C L O; Savioli, Amanda F; Santos, Dayanna S; Lamas, José L T

2013-08-01

The aim of the study was to evaluate the accuracy of the oscillometric blood pressure section in the DX 2020 Dixtal multiparametric monitor in adults according to the European Society of Hypertension-International Protocol as revised in 2010 (ESH-IP 2010). The blood pressure was sequentially verified in 33 individuals admitted to an adult ICU (18 men, mean age 44 years) with a mercury column sphygmomanometer (two observers) and the DX 2020 test device (one supervisor). Ninety-nine pairs of differences were obtained. Data analysis followed the ESH-IP 2010 requirements. In the first requirement, the DX 2020 device failed in the validation study in the 5, 10, and 15 mmHg ranges. From the 99 pairs of differences, only 43/73, 69/87, and 81/96 were obtained for systolic blood pressure and 29/65, 56/81, and 71/93 were obtained for diastolic blood pressure. In the second requirement, at least 24 individuals should have, from their comparisons, two under 0-5 mmHg ranges, which was observed only with 16 individuals in the systolic and nine in the diastolic range. Moreover, at maximum, only three readings could have differences of more than 5 mmHg, and this was observed in 10 individuals in the systolic range and 17 individuals in the diastolic range. The DX 2020 automatic multiparametric monitor for blood pressure measurement has not been recommended for clinical use according to the ESH-IP 2010. It is important to highlight that this work refers only to a blood pressure measurement module and that the same conclusion cannot be drawn for its other functions.

Validation of the Beneware model ABP-021 ambulatory blood pressure monitor according to the revised 2010 European Society of hypertension international protocol.

PubMed

Pereira, Telmo; Guimarães, João

2018-06-11

This study aimed to evaluate the accuracy of the Beneware model ABP-021 oscillometric blood pressure monitor in the general population according to the European Society of Hypertension International Protocol (ESH-IP). The accuracy of the device was assessed in relation to various clinical variables, including age, sex, BMI, and arm circumference. Thirty-three individuals (18 men and 15 women), with a mean age of 36±14 years (age range: 20-68 years), were studied according to the recommendations of the ESH-IP. Sequential same-arm blood pressure measurements were performed, alternating between a mercury standard and the automatic device. The differences among the test-control measurements were assessed and divided into categorization zones of 5, 10, and 15 mmHg discrepancy. The device complied with the quality requirements of the ESH-IP. The device-observer disagreement was -1.2±4.7 mmHg for systolic blood pressure (SBP) and -1.7±4.3 mmHg for diastolic blood pressure (DBP). The device produced 77, 93, and 98 measurements, respectively, within the 5, 10, and 15 mmHg discrepancy limits for SBP. For DBP, 80, 97, and 99 measurements were observed within the 5, 10, and 15 mmHg discrepancy limits. The number of participants with two or three of the device-observer differences within 5 mmHg was 26 for SBP and 29 for DBP, whereas there were only two participants with no device-observer differences within 5 mmHg for DBP. These data show that the Beneware model ABP-021 monitor meets the requirements of the ESH-IP, in static conditions, indicating its suitability for measuring blood pressure in the general adult population.

Variation in population levels of physical activity in European children and adolescents according to cross-European studies: a systematic literature review within DEDIPAC.

PubMed

Van Hecke, Linde; Loyen, Anne; Verloigne, Maïté; van der Ploeg, Hidde P; Lakerveld, Jeroen; Brug, Johannes; De Bourdeaudhuij, Ilse; Ekelund, Ulf; Donnelly, Alan; Hendriksen, Ingrid; Deforche, Benedicte

2016-06-28

Regular physical activity is associated with physical, social and mental health benefits, whilst insufficient physical activity is associated with several negative health outcomes (e.g. metabolic problems). Population monitoring of physical activity is important to gain insight into prevalence of compliance to physical activity recommendations, groups at risk and changes in physical activity patterns. This review aims to provide an overview of all existing studies that measure physical activity in youth, in cross-European studies, to describe the variation in population levels of physical activity and to describe and define challenges regarding assessment methods that are used. A systematic search was performed on six databases (PubMed, EMBASE, CINAHL, PsycINFO, SportDiscus and OpenGrey), supplemental forward- and backward tracking was done and authors' and experts' literature databases were searched to identify relevant articles. Journal articles or reports that reported levels of physical activity in the general population of youth from cross-European studies were included. Data were reviewed, extracted and assessed by two researchers, with disagreements being resolved by a third researcher. The review protocol of this review is published under registration number CRD42014010684 in the PROSPERO database. The search resulted in 9756 identified records of which 30 articles were included in the current review. This review revealed large differences between countries in prevalence of compliance to physical activity recommendations (i.e. 60 min of daily moderate- to vigorous-intensity physical activity (MVPA)) measured subjectively (5-47%) and accelerometer measured minutes of MVPA (23-200 min). Overall boys and children were more active than girls and adolescents. Different measurement methods (subjective n = 12, objective n = 18) and reported outcome variables (n = 17) were used in the included articles. Different accelerometer intensity thresholds used to define MVPA resulted in substantial differences in MVPA between studies conducted in the same countries when assessed objectively. Reported levels of physical activity and prevalence of compliance to physical activity recommendations in youth showed large variation across European countries. This may reflect true variation in physical activity as well as variation in assessment methods and reported outcome variables. Standardization across Europe, of methods to assess physical activity in youth and reported outcome variables is warranted, preferably moving towards a pan-European surveillance system combining objective and self-report methods.

An adaptive toolkit for image quality evaluation in system performance test of digital breast tomosynthesis

NASA Astrophysics Data System (ADS)

Zhang, Guozhi; Petrov, Dimitar; Marshall, Nicholas; Bosmans, Hilde

2017-03-01

Digital breast tomosynthesis (DBT) is a relatively new diagnostic imaging modality for women. Currently, various models of DBT systems are available on the market and the number of installations is rapidly increasing. EUREF, the European Reference Organization for Quality Assured Breast Screening and Diagnostic Services, has proposed a preliminary Guideline - protocol for the quality control of the physical and technical aspects of digital breast tomosynthesis systems, with an ultimate aim of providing limiting values guaranteeing proper performance for different applications of DBT. In this work, we introduce an adaptive toolkit developed in accordance with this guideline to facilitate the process of image quality evaluation in DBT performance test. This toolkit implements robust algorithms to quantify various technical parameters of DBT images and provides a convenient user interface in practice. Each test is built into a separate module with configurations set corresponding to the European guideline, which can be easily adapted to different settings and extended with additional tests. This toolkit largely improves the efficiency for image quality evaluation of DBT. It is also going to evolve with the development of protocols in quality control of DBT systems.

A systematic review of diastolic stress tests in heart failure with preserved ejection fraction, with proposals from the EU-FP7 MEDIA study group.

PubMed

Erdei, Tamás; Smiseth, Otto A; Marino, Paolo; Fraser, Alan G

2014-12-01

Cardiac function should be assessed during stress in patients with suspected heart failure with preserved ejection fraction (HFPEF), but it is unclear how to define impaired diastolic reserve. We conducted a systematic review to identify which pathophysiological changes serve as appropriate targets for diagnostic imaging. We identified 38 studies of 1111 patients with HFPEF (mean age 65 years), 744 control patients without HFPEF, and 458 healthy subjects. Qualifying EF was >45-55%; diastolic dysfunction at rest was a required criterion in 45% of studies. The initial workload during bicycle exercise (25 studies) varied from 12.5 to 30 W (mean 23.1 ± 4.6), with increments of 10-25 W (mean 19.9 ± 6) and stage duration 1-5 min (mean 2.5 ± 1); targets were submaximal (n = 8) or maximal (n = 17). Other protocols used treadmill exercise, handgrip, dobutamine, lower body negative pressure, nitroprusside, fluid challenge, leg raising, or atrial pacing. Reproducibility of echocardiographic variables during stress and validation against independent reference criteria were assessed in few studies. Change in E/e' was the most frequent measurement, but there is insufficient evidence to establish this or other tests for routine use when evaluating patients with HFPEF. To meet the clinical requirements of performing stress testing in elderly subjects, we propose a ramped exercise protocol on a semi-supine bicycle, starting at 15 W, with increments of 5 W/min to a submaximal target (heart rate 100-110 b.p.m., or symptoms). Measurements during submaximal and recovery stages should include changes from baseline in LV long-axis function and indirect echocardiographic indices of LV diastolic pressure. © 2014 The Authors. European Journal of Heart Failure © 2014 European Society of Cardiology.

Understanding healthcare practices in superdiverse neighbourhoods and developing the concept of welfare bricolage: Protocol of a cross-national mixed-methods study.

PubMed

Phillimore, Jenny; Bradby, Hannah; Knecht, Michi; Padilla, Beatriz; Brand, Tilman; Cheung, Sin Yi; Pemberton, Simon; Zeeb, Hajo

2015-06-28

Diversity in Europe has both increased and become more complex posing challenges to both national and local welfare state regimes. Evidence indicates specific barriers for migrant, faith and minority ethnic groups when accessing healthcare. However, previous studies of health in diverse cities in European countries have mainly adopted an ethno-national focus. Taking into account the new complexity of diversity within cities, a deeper and multi-faceted understanding of everyday health practices in superdiverse contexts is needed to support appropriate healthcare provision. This protocol describes a mixed method study investigating how residents in superdiverse neighbourhoods access healthcare. The study will include participant observation and qualitative interviewing as well as a standardised health survey and will be carried out in eight superdiverse neighbourhoods - with varying deprivations levels and trajectories of change - in four European countries (Germany, Portugal, Sweden and UK). In each neighbourhood, trained polylingual community researchers together with university researchers will map formal and informal provision and infrastructures supportive to health and healthcare. In-depth interviews with residents and healthcare providers in each country will investigate local health-supportive practices. Thematic analysis will be used to identify different types of help-seeking behaviours and support structures across neighbourhoods and countries. Using categories identified from analyses of interview material, a health survey will be set up investigating determinants of access to healthcare. Complex models, such as structural equation modelling, will be applied to analyse commonalities and differences between population groups, neighbourhoods and countries. This study offers the potential to contribute to a deeper understanding of how residents in superdiverse neighbourhoods deal with health and healthcare in everyday practices. The findings will inform governmental authorities, formal and informal healthcare providers how to further refine health services and how to achieve equitable access in diverse population groups.

Objectively Measured Physical Activity in European Adults: Cross-Sectional Findings from the Food4Me Study

PubMed Central

Marsaux, Cyril F. M.; Celis-Morales, Carlos; Hoonhout, Jettie; Claassen, Arjan; Goris, Annelies; Forster, Hannah; Fallaize, Rosalind; Macready, Anna L.; Navas-Carretero, Santiago; Kolossa, Silvia; Walsh, Marianne C.; Lambrinou, Christina-Paulina; Manios, Yannis; Godlewska, Magdalena; Traczyk, Iwona; Lovegrove, Julie A.; Martinez, J. Alfredo; Daniel, Hannelore; Gibney, Mike; Mathers, John C.; Saris, Wim H. M.

2016-01-01

Background Comparisons of objectively measured physical activity (PA) between residents of European countries measured concurrently with the same protocol are lacking. We aimed to compare PA between the seven European countries involved in the Food4Me Study, using accelerometer data collected remotely via the Internet. Methods Of the 1607 participants recruited, 1287 (539 men and 748 women) provided at least 3 weekdays and 2 weekend days of valid accelerometer data (TracmorD) at baseline and were included in the present analyses. Results Men were significantly more active than women (physical activity level = 1.74 vs. 1.70, p < 0.001). Time spent in light PA and moderate PA differed significantly between countries but only for women. Adherence to the World Health Organization recommendation to accumulate at least 150 min of moderate-equivalent PA weekly was similar between countries for men (range: 54–65%) but differed significantly between countries for women (range: 26–49%). Prevalence estimates decreased substantially for men and women in all seven countries when PA guidelines were defined as achieving 30 min of moderate and vigorous PA per day. Conclusions We were able to obtain valid accelerometer data in real time via the Internet from 80% of participants. Although our estimates are higher compared with data from Sweden, Norway, Portugal and the US, there is room for improvement in PA for all countries involved in the Food4Me Study. PMID:26999053

Patient privacy protection using anonymous access control techniques.

PubMed

Weerasinghe, D; Rajarajan, M; Elmufti, K; Rakocevic, V

2008-01-01

The objective of this study is to develop a solution to preserve security and privacy in a healthcare environment where health-sensitive information will be accessed by many parties and stored in various distributed databases. The solution should maintain anonymous medical records and it should be able to link anonymous medical information in distributed databases into a single patient medical record with the patient identity. In this paper we present a protocol that can be used to authenticate and authorize patients to healthcare services without providing the patient identification. Healthcare service can identify the patient using separate temporary identities in each identification session and medical records are linked to these temporary identities. Temporary identities can be used to enable record linkage and reverse track real patient identity in critical medical situations. The proposed protocol provides main security and privacy services such as user anonymity, message privacy, message confidentiality, user authentication, user authorization and message replay attacks. The medical environment validates the patient at the healthcare service as a real and registered patient for the medical services. Using the proposed protocol, the patient anonymous medical records at different healthcare services can be linked into one single report and it is possible to securely reverse track anonymous patient into the real identity. The protocol protects the patient privacy with a secure anonymous authentication to healthcare services and medical record registries according to the European and the UK legislations, where the patient real identity is not disclosed with the distributed patient medical records.

Considerations of nano-QSAR/QSPR models for nanopesticide risk assessment within the European legislative framework.

PubMed

Villaverde, Juan José; Sevilla-Morán, Beatriz; López-Goti, Carmen; Alonso-Prados, José Luis; Sandín-España, Pilar

2018-09-01

The European market for pesticides is currently legislated through the well-developed Regulation (EC) No. 1107/2009. This regulation promotes the competitiveness of European agriculture, recognizing the necessity of safe pesticides for human and animal health and the environment to protect crops against pests, diseases and weeds. In this sense, nanotechnology can provide a tremendous opportunity to achieve a more rational use of pesticides. However, the lack of information regarding nanopesticides and their fate and behavior in the environment and their effects on human and animal health is inhibiting rapid nanopesticide incorporation into European Union agriculture. This review analyzes the recent state of knowledge on nanopesticide risk assessment, highlighting the challenges that need to be overcame to accelerate the arrival of these new tools for plant protection to European agricultural professionals. Novel nano-Quantitative Structure-Activity/Structure-Property Relationship (nano-QSAR/QSPR) tools for risk assessment are analyzed, including modeling methods and validation procedures towards the potential of these computational instruments to meet the current requirements for authorization of nanoformulations. Future trends on these issues, of pressing importance within the context of the current European pesticide legislative framework, are also discussed. Standard protocols to make high-quality and well-described datasets for the series of related but differently sized nanoparticles/nanopesticides are required. Copyright © 2018 Elsevier B.V. All rights reserved.

An investigation into current protocols and radiographer opinions on contrast extravasation in Irish CT departments.

PubMed

Cleary, N; McNulty, J P; Foley, S J; Kelly, E

2017-11-01

Iodinated contrast extravasation is a serious complication associated with intravenous administration in radiology. Departmental protocols and the radiographer's approach on both prevention techniques and treatment will affect the prevalence of extravasation, and the eventual outcome for the patient when it does occur. To examine contrast extravasation protocols in place in Irish CT departments for alignment with European Society of Urogenital Radiology (ESUR) Guidelines (2014); to establish radiographer's opinions on contrast extravasation; and to examine radiographer adherence to protocols. Contrast extravasation protocols from a purposively selected sample of CT departments across Ireland (n = 6) were compared to ESUR guidelines, followed by an online survey of CT radiographers practicing in the participating centres. All participating CT departments (n = 5) had written protocols in place. High risk patients, such as elderly or unconscious, were identified in most protocols, however, children were mentioned in just one protocol and obese patients were not specified in any. The response rate of CT radiographers was 23% (n = 24). 58% (n = 14) of respondents indicated that contrast extravasation was more likely during CTA examinations. While high levels of confidence in managing extravasation were reported, suggested treatment approaches, and confidence in same, was more variable. Clinical workload in CT departments was also identified as a factor impacting on patient care and management. While contrast extravasation protocols were generally in line with ESUR Guidelines, high risk patients may not be getting sufficient attention. More radiographer awareness of patient monitoring needs, particularly in busy departments with a heavy workload may also reduce extravasation risk, and improve management of same. Copyright © 2017 The College of Radiographers. Published by Elsevier Ltd. All rights reserved.

Definition of major bleeding in clinical investigations of antihemostatic medicinal products in surgical patients.

PubMed

Schulman, S; Angerås, U; Bergqvist, D; Eriksson, B; Lassen, M R; Fisher, W

2010-01-01

The definition of major bleeding varies between studies on surgical patients, particularly regarding the criteria for surgical wound-related bleeding. This diversity contributes to the difficulties in comparing data between trials. The Scientific and Standardization Committee (SSC), through its subcommittee on Control of Anticoagulation, of the International Society on Thrombosis and Haemostasis has previously published a recommendation for a harmonized definition of major bleeding in non-surgical studies. That definition has been adopted by the European Medicines Agency and is currently used in several non-surgical trials. A preliminary proposal for a parallel definition for surgical studies was presented at the 54(th) Annual Meeting of the SSC in Vienna, July 2008. Based on those discussions and further consultations with European and North American surgeons with experience from clinical trials a definition has been developed that should be applicable to all agents that interfere with hemostasis. The definition and the text that follows have been reviewed and approved by relevant co-chairs of the subcommittee and by the Executive Committee of the SSC. The intention is to seek approval of this definition from the regulatory authorities to enhance its incorporation into future clinical trial protocols.

"SWING": A European project for a new application of an ionospheric network

NASA Astrophysics Data System (ADS)

Zolesi, B.; Bianchi, C.; Meloni, A.; Baskaradas, J. A.; Belehaki, A.; Altadill, D.; Dalle Mese, E.

2016-05-01

The SWING (Short Wave critical Infrastructure Network based on a new Generation high survival radio communication system) is a European project aimed at studying a high survival high-frequency (HF) radio network to link European Critical Infrastructures (ECIs). This system is thought to replace broadband internet communication, maintaining the minimum flux of essential information for the ECIs management and control, in case of wide-scale threats, including terrorist attacks, able to put out of order internet links over the Mediterranean region. SWING is designed to evaluate the threat and increase the security awareness, as well as the level of protection, of analogous and/or interdependent ECIs. In order to meet these goals, SWING was finalized to recognize how and when the internet communication fails and to develop the standard software and hardware tools necessary for implementing communication protocols suited for a reliable and interoperable short-wave (SW) or high-frequency (HF) radio network backup. The internet broadband description and internet failure recognition were taken into consideration in the project but are not treated in this paper. It has been assessed that in case of complete failure of the internet broadband communication fundamental information for the management and control of ECIs over the Mediterranean region can be maintained with a HF network, even in case of moderate ionospheric perturbations.

Magnetic resonance imaging in patients with cardiac implanted electronic devices: focus on contraindications to magnetic resonance imaging protocols.

PubMed

Horwood, Laura; Attili, Anil; Luba, Frank; Ibrahim, El-Sayed H; Parmar, Hemant; Stojanovska, Jadranka; Gadoth-Goodman, Sharon; Fette, Carey; Oral, Hakan; Bogun, Frank

2017-05-01

Magnetic resonance imaging (MRI) has been reported to be safe in patients with cardiac implantable electronic devices (CIED) provided a specific protocol is followed. The objective of this study was to assess whether this is also true for patients excluded from published protocols. A total of 160 MRIs were obtained in 142 consecutive patients with CIEDs [106 patients had an implantable cardioverter defibrillator (ICD) and 36 had a pacemaker implanted] using an adapted, pre-specified protocol. A cardiac MRI was performed in 95 patients, and a spinal/brain MRI was performed in 47 patients. Forty-six patients (32%) had either abandoned leads (n = 10), and/or were pacemaker dependent with an implanted ICD (n = 19), had recently implanted CIEDs (n = 1), and/or had a CIED device with battery depletion (n = 2), and/or a component of the CIED was recalled or on advisory (n = 32). No major complications occurred. Some device parameters changed slightly, but significantly, right after or at 1-week post-MRI without requiring any reprogramming. In one patient with an ICD on advisory, the pacing rate changed inexplicably during one of his two MRIs from 90 to 50 b.p.m. Using a pre-specified protocol, cardiac and non-cardiac MRIs were performed in CIED patients with pacemaker dependency, abandoned leads, or depleted batteries without occurrence of major adverse events. Patients with devices on advisory need to be monitored carefully during MRI, especially if they are pacemaker dependent. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.

Nuclear cardiology practice and associated radiation doses in Europe: results of the IAEA Nuclear Cardiology Protocols Study (INCAPS) for the 27 European countries.

PubMed

Lindner, Oliver; Pascual, Thomas N B; Mercuri, Mathew; Acampa, Wanda; Burchert, Wolfgang; Flotats, Albert; Kaufmann, Philipp A; Kitsiou, Anastasia; Knuuti, Juhani; Underwood, S Richard; Vitola, João V; Mahmarian, John J; Karthikeyan, Ganesan; Better, Nathan; Rehani, Madan M; Kashyap, Ravi; Dondi, Maurizio; Paez, Diana; Einstein, Andrew J

2016-04-01

Nuclear cardiology is widely used to diagnose coronary artery disease and to guide patient management, but data on current practices, radiation dose-related best practices, and radiation doses are scarce. To address these issues, the IAEA conducted a worldwide study of nuclear cardiology practice. We present the European subanalysis. In March 2013, the IAEA invited laboratories across the world to document all SPECT and PET studies performed in one week. The data included age, gender, weight, radiopharmaceuticals, injected activities, camera type, positioning, hardware and software. Radiation effective dose was calculated for each patient. A quality score was defined for each laboratory as the number followed of eight predefined best practices with a bearing on radiation exposure (range of quality score 0 - 8). The participating European countries were assigned to regions (North, East, South, and West). Comparisons were performed between the four European regions and between Europe and the rest-of-the-world (RoW). Data on 2,381 European patients undergoing nuclear cardiology procedures in 102 laboratories in 27 countries were collected. A cardiac SPECT study was performed in 97.9 % of the patients, and a PET study in 2.1 %. The average effective dose of SPECT was 8.0 ± 3.4 mSv (RoW 11.4 ± 4.3 mSv; P < 0.001) and of PET was 2.6 ± 1.5 mSv (RoW 3.8 ± 2.5 mSv; P < 0.001). The mean effective doses of SPECT and PET differed between European regions (P < 0.001 and P = 0.002, respectively). The mean quality score was 6.2 ± 1.2, which was higher than the RoW score (5.0 ± 1.1; P < 0.001). Adherence to best practices did not differ significantly among the European regions (range 6 to 6.4; P = 0.73). Of the best practices, stress-only imaging and weight-adjusted dosing were the least commonly used. In Europe, the mean effective dose from nuclear cardiology is lower and the average quality score is higher than in the RoW. There is regional variation in effective dose in relation to the best practice quality score. A possible reason for the differences between Europe and the RoW could be the safety culture fostered by actions under the Euratom directives and the implementation of diagnostic reference levels. Stress-only imaging and weight-adjusted activity might be targets for optimization of European nuclear cardiology practice.

Safety and efficacy of colistin versus meropenem in the empirical treatment of ventilator-associated pneumonia as part of a macro-project funded by the Seventh Framework Program of the European Commission studying off-patent antibiotics: study protocol for a randomized controlled trial.

PubMed

Rosso-Fernández, Clara; Garnacho-Montero, José; Antonelli, Massimo; Dimopoulos, George; Cisneros, José Miguel

2015-03-20

Ventilator-associated pneumonia (VAP) is one of the most common and severe hospital-adquired infections, and multidrugresistant gram-negative bacilli (MDR-GNB) constitute the main etiology in many countries. Inappropriate empiric antimicrobial treatment is associated with increased mortality. In this context, the empirical treatment of choice for VAP is unknown. Colistin, is now the antimicrobial with greatest in vitro activity against MDR-GNB. The MagicBullet clinical trial is an investigator-driven clinical study, funded by the Seventh Framework Program of the European Commission. This is designed as a phase IV, randomized, controlled, open label, non-inferiority and international trial to assess the safety and efficacy of colistin versus meropenem in late onset VAP. The study is conducted in a total of 32 centers in three European countries (Spain, Italy and Greece) with specific high incidences of infections caused by MDR-GNB. Patients older than 18 years who develop VAP with both clinical and radiological signs, and are on mechanical ventilation for more than 96 hours, or less than 96 hours but with previous antibiotic treatment plus one week of hospitalization, are candidates for inclusion in the study. A total sample size of 496 patients will be randomized according to a severity clinical score (at the time of VAP diagnosis in a 1:1 ratio to receive either colistin 4.5 MU as a loading dose, followed by 3 MU every eight hours (experimental arm), or meropenem 2 g every eight hours (control arm), both combined with levofloxacin. Mortality from any cause at 28 days will be considered as the main outcome. Clinical and microbiological cure will be evaluated at 72 hours, eight days, the finalization of antibiotic treatment, and 28 days of follow-up. The efficacy evaluation will be performed in every patient who receives at least one study treatment drug, and with etiologic diagnosis of VAP, intention-to-treat population and per protocol analysis will be performed. Currently, there is no study being undertaken which analyzes empiric treatment of (VAP) with a suspicion of multi-resistance. Colistin, an off-patent antibiotic commercialized for more than 60 years, could widen the antibiotic alternatives for a high-mortality illness aggravated by antibiotic resistance. This trial is registered with ClinicalTrials.gov (identifier: NCT01292031 ; registered on 29 June 2012) and EudraCT (identifier: 2010-023310-31; registered on 7 February 2011).

Effect modification of FADS2 polymorphisms on the association between breastfeeding and intelligence: protocol for a collaborative meta-analysis.

PubMed

Hartwig, Fernando Pires; Davies, Neil Martin; Horta, Bernardo Lessa; Victora, Cesar Gomes; Davey Smith, George

2016-06-15

Evidence from observational studies and randomised controlled trials suggests that breastfeeding is positively associated with IQ, possibly because breast milk is a source of long-chain polyunsaturated fatty acids. Different studies have detected gene-breastfeeding interactions involving FADS2 variants and intelligence. However, findings are inconsistent regarding the direction of such effect modification. To clarify how FADS2 and breastfeeding interact in their association with IQ, we are conducting a consortium-based meta-analysis of independent studies. Results produced by each individual study using standardised analysis scripts and harmonised data will be used. breastfeeding, IQ and either rs174575 or rs1535 polymorphisms available; and being of European ancestry. twin studies; only poorly imputed genetic data available; or unavailability of proper ethics approval. Studies will be invited based on being known to have at least some of the required data, or suggested by participating studies as potentially eligible. This inclusive approach will favour achieving a larger sample size and be less prone to publication bias. Improving current understanding of FADS2-breastfeeding interaction may provide important biological insights regarding the importance of long-chain polyunsaturated fatty acids for the breastfeeding-IQ association. This meta-analysis will help to improve such knowledge by replicating earlier studies, conducting additional analysis and evaluating different sources of heterogeneity. Publishing this protocol will minimise the possibility of bias due to post hoc changes to the analysis protocol. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Innovative treatment modalities for urinary incontinence: a European survey identifying experience and attitude of healthcare providers.

PubMed

Kastelein, Arnoud W; Dicker, Maarten F A; Opmeer, Brent C; Angles, Sonia S; Raatikainen, Kaisa E; Alonso, Joan F; Tăut, Diana; Airaksinen, Olavi; Cardozo, Linda D; Roovers, Jan-Paul W R

2017-11-01

Urinary incontinence is a common condition in women, with a reported prevalence ranging from 25% to 51%. Of these women, an estimated 38% suffer from stress urinary incontinence (SUI). A European research consortium is investigating an innovative system based on information and communication technology for the conservative treatment of women with SUI. When introducing a new intervention, implementation barriers arise and need to be identified. Therefore, we investigated healthcare providers' experience with and attitude towards innovative care options. We performed an online survey to assess (1) the characteristics and practice of healthcare providers, (2) current protocols for SUI, (3) current use of biofeedback, and (4) knowledge about serious gaming. The survey was sent to members of professional societies in Europe (EUGA), UK (BSUG) and The Netherlands (DPFS). Of 341 questionnaires analyzed (response rate between 18% and 30%), 64% of the respondents had access to a protocol for the treatment of SUI, and 31% used biofeedback when treating patients with SUI. However, 92% considered that biofeedback has a clear or probable added value, and 97% of those who did not use biofeedback would change their practice if research evidence supported its use. Finally, 89% of respondents indicated that they had no experience of serious gaming, but 92% considered that it could be useful. Although inexperienced, European urogynecologists and physical therapists welcome innovative treatment options for the conservative treatment of SUI such as portable wireless biofeedback and serious gaming. Scientific evidence is considered a prerequisite to incorporate such innovations into clinical practice.

European distributed seismological data archives infrastructure: EIDA

NASA Astrophysics Data System (ADS)

Clinton, John; Hanka, Winfried; Mazza, Salvatore; Pederson, Helle; Sleeman, Reinoud; Stammler, Klaus; Strollo, Angelo

2014-05-01

The European Integrated waveform Data Archive (EIDA) is a distributed Data Center system within ORFEUS that (a) securely archives seismic waveform data and related metadata gathered by European research infrastructures, and (b) provides transparent access to the archives for the geosciences research communities. EIDA was founded in 2013 by ORFEUS Data Center, GFZ, RESIF, ETH, INGV and BGR to ensure sustainability of a distributed archive system and the implementation of standards (e.g. FDSN StationXML, FDSN webservices) and coordinate new developments. Under the mandate of the ORFEUS Board of Directors and Executive Committee the founding group is responsible for steering and maintaining the technical developments and organization of the European distributed seismic waveform data archive and the integration within broader multidisciplanry frameworks like EPOS. EIDA currently offers uniform data access to unrestricted data from 8 European archives (www.orfeus-eu.org/eida), linked by the Arclink protocol, hosting data from 75 permanent networks (1800+ stations) and 33 temporary networks (1200+) stations). Moreover, each archive may also provide unique, restricted datasets. A webinterface, developed at GFZ, offers interactive access to different catalogues (EMSC, GFZ, USGS) and EIDA waveform data. Clients and toolboxes like arclink_fetch and ObsPy can connect directly to any EIDA node to collect data. Current developments are directed to the implementation of quality parameters and strong motion parameters.

The impact of different cone beam computed tomography and multi-slice computed tomography scan parameters on virtual three-dimensional model accuracy using a highly precise ex vivo evaluation method.

PubMed

Matta, Ragai-Edward; von Wilmowsky, Cornelius; Neuhuber, Winfried; Lell, Michael; Neukam, Friedrich W; Adler, Werner; Wichmann, Manfred; Bergauer, Bastian

2016-05-01

Multi-slice computed tomography (MSCT) and cone beam computed tomography (CBCT) are indispensable imaging techniques in advanced medicine. The possibility of creating virtual and corporal three-dimensional (3D) models enables detailed planning in craniofacial and oral surgery. The objective of this study was to evaluate the impact of different scan protocols for CBCT and MSCT on virtual 3D model accuracy using a software-based evaluation method that excludes human measurement errors. MSCT and CBCT scans with different manufacturers' predefined scan protocols were obtained from a human lower jaw and were superimposed with a master model generated by an optical scan of an industrial noncontact scanner. To determine the accuracy, the mean and standard deviations were calculated, and t-tests were used for comparisons between the different settings. Averaged over 10 repeated X-ray scans per method and 19 measurement points per scan (n = 190), it was found that the MSCT scan protocol 140 kV delivered the most accurate virtual 3D model, with a mean deviation of 0.106 mm compared to the master model. Only the CBCT scans with 0.2-voxel resolution delivered a similar accurate 3D model (mean deviation 0.119 mm). Within the limitations of this study, it was demonstrated that the accuracy of a 3D model of the lower jaw depends on the protocol used for MSCT and CBCT scans. Copyright © 2016 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

Pressure ulcer and patient characteristics--A point prevalence study in a tertiary hospital of India based on the European Pressure Ulcer Advisory Panel minimum data set.

PubMed

Mehta, Chitra; George, Joby V; Mehta, Yatin; Wangmo, Namgyal

2015-08-01

Pressure ulcers is a frequent problem in hospitalized patients. Several prevalence studies have been conducted across the globe. Little information is available regarding prevalence of pressure ulcers in India. The aim was to identify the prevalence of pressure ulcers in one of the tertiary hospital in northern India and the factors associated with its development. A cross sectional point prevalence study. European Pressure Ulcer Advisory Panel (EPUAP) data collection form. Ethics approval was obtained prior to start of the study. Total of 358 patients were enrolled in the study. All patients above 18 years of age admitted in intensive care units and wards were included in the study. Patients admitted in emergency, day care, coronary care unit were excluded because of their short duration of hospital stay (varies from 24 to 72 h usually). All patients admitted before midnight on the predetermined day were included. The Braden scale was used to identify the risk of developing pressure ulcers. European Pressure ulcer advisory panel (EPUAP) minimum data set was used to collect prevalence data. The overall prevalence rate was 7.8%.The sacrum and heel were more commonly affected. Grade III pressure ulcers were the most common (42.8%). The pressure ulcer prevalence rate in our hospital was lower than that published in international studies. Severe forms of pressure ulcers were commonly encountered This data provides background information that may help us in developing protocols for applying effective practices for prevention of pressure ulcers. Copyright © 2015 Tissue Viability Society. Published by Elsevier Ltd. All rights reserved.

Clinical effects of probiotics in cystic fibrosis patients: A systematic review.

PubMed

Van Biervliet, Stephanie; Declercq, Dimitri; Somerset, Shawn

2017-04-01

Cystic fibrosis (CF) is characterised by a build-up of thick, intransient mucus linings of the digestive and respiratory mucosa, which disrupts digestive system functioning and microbiota composition. In view of the potential for probiotics to enhance microbiota composition in other contexts, this study investigated the current evidence for probiotics as an adjunct to usual therapy for CF. Electronic clinical databases were interrogated for human randomised, controlled, intervention trials (1985-2015) testing the effects of probiotics on clinical endpoints in CF were reviewed. From 191 articles identified in initial searches, six studies met the critical inclusion criteria, and were reviewed in detail. These studies varied in size (n = 22 to 61) but were generally small and showed substantial diversity in protocol, specific probiotic species used and range of clinical outcomes measured. Probiotic administration showed beneficial effects on fecal calprotectin levels, pulmonary exacerbation risk, and quality of life indicators. In one study, such changes were associated with variations in gut microbiota composition. Despite encouraging preliminary results, the limited number of small and highly varied studies to date do not justify the addition of probiotics as an adjunct to current CF treatment protocols. Importantly, very minimal adverse effects of probiotics have been reported. Copyright © 2017 European Society for Clinical Nutrition and Metabolism. Published by Elsevier Ltd. All rights reserved.

User-Centered Design of Serious Games for Older Adults Following 3 Years of Experience With Exergames for Seniors: A Study Design

PubMed Central

2017-01-01

Background Seniors need sufficient balance and strength to manage in daily life, and sufficient physical activity is required to achieve and maintain these abilities. This can be a challenge, but fun and motivational exergames can be of help. However, most commercial games are not suited for this age group for several reasons. Many usability studies and user-centered design (UCD) protocols have been developed and applied, but to the best of our knowledge none of them are focusing on seniors’ use of games for physical activity. In GameUp, a European cofunded project, some prototype Kinect exergames to enhance the mobility of seniors were developed in a user-centered approach. Objective In this paper we aim to record lessons learned in 3 years of experience with exergames for seniors, considering both the needs of older adults regarding user-centered development of exergames and participation in UCD. We also provide a UCD protocol for exergames tailored to senior needs. Methods An initial UCD protocol was formed based on literature of previous research outcomes. Senior users participated in UCD following the initial protocol. The users formed a steady group that met every second week for 3 years to play exergames and participate in the UCD during the 4 phases of the protocol. Several methods were applied in the 4 different phases of the UCD protocol; the most important methods were structured and semistructured interviews, observations, and group discussions. Results A total of 16 seniors with an average age above 80 years participated for 3 years in UCD in order to develop the GameUp exergames. As a result of the lessons learned by applying the different methodologies of the UCD protocol, we propose an adjusted UCD protocol providing explanations on how it should be applied for seniors as users. Questionnaires should be turned into semistructured and structured interviews while user consultation sessions should be repeated with the same theme to ensure that the UCD methods produce a valid outcome. By first following the initial and gradually the adjusted UCD protocol, the project resulted in exergame functionalities and interface features for seniors. Conclusions The main lessons learned during 3 years of experience with exergames for seniors applying UCD are that devoting time to seniors is a key element of success so that trust can be gained, communication can be established, and users’ opinions can be recorded. All different game elements should be taken into consideration during the design of exergames for seniors even if they seem obvious. Despite the limitations of this study, one might argue that it provides a best practice guide to the development of serious games for physical activity targeting seniors. PMID:28077348

Trial of validation of two devices for self-measurement of blood pressure according to the European Society of Hypertension International Protocol: the Citizen CH-432B and the Citizen CH-656C.

PubMed

Cotte, Uwe V; Faltenbacher, Verena H; von Willich, Werner; Bogner, Johannes R

2008-02-01

Two devices for self-measurement of blood pressure, one at the upper arm (Citizen CH-432B) and one at the wrist (Citizen CH-656C), were evaluated according to the International Protocol of the European Society of Hypertension. The International Protocol is divided into two phases: the first phase is performed on 15 selected participants with five participants in three different blood pressure ranges. If the devices passed this phase, 18 additional participants selected on the basis of the same criteria as in phase 1 were included. Two skilled observers performed the following blood pressure measurements: five measurements were performed with the mercury standard alternating with four measurements with each of the test devices per participant. The first measurement result from each device instrument was not included in the analysis. The difference between the blood pressure value given by the devices and that obtained by the two observers (mean of the two observers) was calculated for each pair of measurements and classified into three categories (within 5, 10 and 15 mmHg). The results were compared to the pass criteria established by the European Society of Hypertension. Afterwards the number of measurement differences falling within 5 mmHg was determined for every person. At least 22 of the 33 participants should have two of their three comparisons within 5 mmHg and there should be a maximum of three participants without a measurement difference within the 5 mmHg range. Both tested devices passed the first phase of the validation process by exceeding the required number of comparisons falling within the 5, 10 and 15 mmHg error zones. Even the second phase confirmed the validation criteria with average differences between the device and the mercury sphygmomanometer of 0.7+/-4.4 and -3.6+/-4.0 mmHg for systolic blood pressure and diastolic blood pressure, respectively, for the Citizen CH-432B device and -0.7+/-6.0 and -1.2+/-4.5 mmHg for the Citizen CH-656C device. Phase 2 contains furthermore an individual analysis of the 33 participants, the requirements of which were also fulfilled by both devices. The Citizen CH-432B and the Citizen CH-656C devices pass the validation recommendations of the International Protocol. They can be recommended for clinical use.

Prevalence of overweight and obesity in European children below the age of 10.

PubMed

Ahrens, W; Pigeot, I; Pohlabeln, H; De Henauw, S; Lissner, L; Molnár, D; Moreno, L A; Tornaritis, M; Veidebaum, T; Siani, A

2014-09-01

There is a lack of common surveillance systems providing comparable figures and temporal trends of the prevalence of overweight (OW), obesity and related risk factors among European preschool and school children. Comparability of available data is limited in terms of sampling design, methodological approaches and quality assurance. The IDEFICS (Identification and prevention of Dietary- and lifestyle-induced health Effects in Children and infantS) study provides one of the largest European data sets of young children based on state-of-the-art methodology. To assess the European distribution of weight status according to different classification systems based on body mass index (BMI) in children (2.0-9.9 years). To describe the prevalence of weight categories by region, sex, age and socioeconomic position. Between 2007 and 2010, 18,745 children from eight European countries participated in an extensive, highly standardised protocol including, among other measures, anthropometric examinations and parental reports on socio-demographic characteristics. The combined prevalence of OW/obesity ranges from more than 40% in southern Europe to less than 10% in northern Europe. Overall, the prevalence of OW was higher in girls (21.1%) as compared with boys (18.6%). The prevalence of OW shows a negative gradient with social position, with some variation of the strength and consistency of this association across Europe. Overall, population groups with low income and/or lower education levels show the highest prevalence of obesity. The use of different reference systems to classify OW results in substantial differences in prevalence estimates and can even reverse the reported difference between boys and girls. There is a higher prevalence of obesity in populations from southern Europe and in population groups with lower education and income levels. Our data confirm the need to develop and reinforce European public health policies to prevent early obesity and to reduce these health inequalities and regional disparities.

How to: Surveillance of Clostridium difficile infections.

PubMed

Krutova, M; Kinross, P; Barbut, F; Hajdu, A; Wilcox, M H; Kuijper, E J

2018-05-01

The increasing incidence of Clostridium difficile infections (CDI) in healthcare settings in Europe since 2003 has affected both patients and healthcare systems. The implementation of effective CDI surveillance is key to enable monitoring of the occurrence and spread of C. difficile in healthcare and the timely detection of outbreaks. The aim of this review is to provide a summary of key components of effective CDI surveillance and to provide some practical recommendations. We also summarize the recent and current national CDI surveillance activities, to illustrate strengths and weaknesses of CDI surveillance in Europe. For the definition of key components of CDI surveillance, we consulted the current European Society of Clinical Microbiology and Infectious Diseases (ESCMID) CDI-related guidance documents and the European Centre for Disease Prevention and Control (ECDC) protocol for CDI surveillance in acute care hospitals. To summarize the recent and current national CDI surveillance activities, we discussed international multicentre CDI surveillance studies performed in 2005-13. In 2017, we also performed a new survey of existing CDI surveillance systems in 33 European countries. Key components for CDI surveillance are appropriate case definitions of CDI, standardized CDI diagnostics, agreement on CDI case origin definition, and the presentation of CDI rates with well-defined numerators and denominators. Incorporation of microbiological data is required to provide information on prevailing PCR ribotypes and antimicrobial susceptibility to first-line CDI treatment drugs. In 2017, 20 European countries had a national CDI surveillance system and 21 countries participated in ECDC-coordinated CDI surveillance. Since 2014, the number of centres with capacity for C. difficile typing has increased to 35 reference or central laboratories in 26 European countries. Incidence rates of CDI, obtained from a standardized CDI surveillance system, can be used as an important quality indicator of healthcare at hospital as well as country level. Copyright © 2017 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

Informed Consent to Study Purpose in Randomized Clinical Trials of Antibiotics, 1991 Through 2011.

PubMed

Doshi, Peter; Hur, Peter; Jones, Mark; Albarmawi, Husam; Jefferson, Tom; Morgan, Daniel J; Spears, Patricia A; Powers, John H

2017-10-01

Potential research participants may assume that randomized trials comparing new interventions with older interventions always hypothesize greater efficacy for the new intervention, as in superiority trials. However, antibiotic trials frequently use "noninferiority" hypotheses allowing a degree of inferior efficacy deemed "clinically acceptable" compared with an older effective drug, in exchange for nonefficacy benefits (eg, decreased adverse effects). Considering these different benefit-harm trade-offs, proper informed consent necessitates supplying different information on the purposes of superiority and noninferiority trials. To determine the degree to which the study purpose is explained to potential participants in randomized clinical trials of antibiotics and the degree to which study protocols justify their selection of noninferiority hypotheses and amount of "clinically acceptable" inferiority. Cross-sectional analysis of study protocols, statistical analysis plans (SAPs), and informed consent forms (ICFs) from clinical study reports submitted to the European Medicines Agency. The ICFs were read by both methodologists and patient investigators. Protocols and SAPs were used as the reference standard to determine prespecified primary hypothesis and record rationale for selection of noninferiority hypotheses and noninferiority margins. This information was cross-referenced against ICFs to determine whether ICFs explained the study purpose. We obtained trial documents from 78 randomized trials with prespecified efficacy hypotheses (6 superiority, 72 noninferiority) for 17 antibiotics conducted between 1991 and 2011 that enrolled 39 407 patients. Fifty were included in the ICF analysis. All ICFs contained sections describing study purpose; however, none consistently conveyed study hypothesis to both methodologists and patient investigators. Methodologists found that 1 of 50 conveyed a study purpose. Patient investigators found that 11 of 50 conveyed a study purpose, 7 accurately and 4 inaccurately compared with the reference standard. Seventy-one of 72 noninferiority trial protocols or SAPs provided no rationale for selection of noninferiority hypothesis. None provided a clinical rationale for the chosen amount of decreased efficacy. Patients were not accurately informed of study purpose, which raises questions regarding the ethics of informed consent in antibiotic trials. Noninferiority and superiority trials entail different benefit-harm trade-offs that must be conveyed for ethical informed consent.

Variation in Blood Transfusion and Coagulation Management in Traumatic Brain Injury at the Intensive Care Unit: A Survey in 66 Neurotrauma Centers Participating in the Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury Study.

PubMed

Huijben, Jilske A; van der Jagt, Mathieu; Cnossen, Maryse C; Kruip, Marieke J H A; Haitsma, Iain K; Stocchetti, Nino; Maas, Andrew I R; Menon, David K; Ercole, Ari; Maegele, Marc; Stanworth, Simon J; Citerio, Giuseppe; Polinder, Suzanne; Steyerberg, Ewout W; Lingsma, Hester F

2017-11-21

Our aim was to describe current approaches and to quantify variability between European intensive care units (ICUs) in patients with traumatic brain injury (TBI). Therefore, we conducted a provider profiling survey as part of the Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI) study. The ICU Questionnaire was sent to 68 centers from 20 countries across Europe and Israel. For this study, we used ICU questions focused on 1) hemoglobin target level (Hb-TL), 2) coagulation management, and 3) deep venous thromboembolism (DVT) prophylaxis. Seventy-eight participants, mostly intensivists and neurosurgeons of 66 centers, completed the ICU questionnaire. For ICU-patients, half of the centers (N = 34; 52%) had a defined Hb-TL in their protocol. For patients with TBI, 26 centers (41%) indicated an Hb-TL between 70 and 90 g/L and 38 centers (59%) above 90 g/L. To treat trauma-related hemostatic abnormalities, the use of fresh frozen plasma (N = 48; 73%) or platelets (N = 34; 52%) was most often reported, followed by the supplementation of vitamin K (N = 26; 39%). Most centers reported using DVT prophylaxis with anticoagulants frequently or always (N = 62; 94%). In the absence of hemorrhagic brain lesions, 14 centers (21%) delayed DVT prophylaxis until 72 h after trauma. If hemorrhagic brain lesions were present, the number of centers delaying DVT prophylaxis for 72 h increased to 29 (46%). Overall, a lack of consensus exists between European ICUs on blood transfusion and coagulation management. The results provide a baseline for the CENTER-TBI study, and the large between-center variation indicates multiple opportunities for comparative effectiveness research.

Clinical efficacy of β-lactam/β-lactamase inhibitor combinations for the treatment of bloodstream infection due to extended-spectrum β-lactamase-producing Enterobacteriaceae in haematological patients with neutropaenia: a study protocol for a retrospective observational study (BICAR)

PubMed Central

Gudiol, C; Royo-Cebrecos, C; Tebe, C; Abdala, E; Akova, M; Álvarez, R; Maestro-de la Calle, G; Cano, A; Cervera, C; Clemente, W T; Martín-Dávila, P; Freifeld, A; Gómez, L; Gottlieb, T; Gurguí, M; Herrera, F; Manzur, A; Maschmeyer, G; Meije, Y; Montejo, M; Peghin, M; Rodríguez-Baño, J; Ruiz-Camps, I; Sukiennik, T C; Carratalà, J

2017-01-01

Introduction Bloodstream infection (BSI) due to extended-spectrum β-lactamase-producing Gram-negative bacilli (ESBL-GNB) is increasing at an alarming pace worldwide. Although β-lactam/β-lactamase inhibitor (BLBLI) combinations have been suggested as an alternative to carbapenems for the treatment of BSI due to these resistant organisms in the general population, their usefulness for the treatment of BSI due to ESBL-GNB in haematological patients with neutropaenia is yet to be elucidated. The aim of the BICAR study is to compare the efficacy of BLBLI combinations with that of carbapenems for the treatment of BSI due to an ESBL-GNB in this population. Methods and analysis A multinational, multicentre, observational retrospective study. Episodes of BSI due to ESBL-GNB occurring in haematological patients and haematopoietic stem cell transplant recipients with neutropaenia from 1 January 2006 to 31 March 2015 will be analysed. The primary end point will be case-fatality rate within 30 days of onset of BSI. The secondary end points will be 7-day and 14-day case-fatality rates, microbiological failure, colonisation/infection by resistant bacteria, superinfection, intensive care unit admission and development of adverse events. Sample size The number of expected episodes of BSI due to ESBL-GNB in the participant centres will be 260 with a ratio of control to experimental participants of 2. Ethics and dissemination The protocol of the study was approved at the first site by the Research Ethics Committee (REC) of Hospital Universitari de Bellvitge. Approval will be also sought from all relevant RECs. Any formal presentation or publication of data from this study will be considered as a joint publication by the participating investigators and will follow the recommendations of the International Committee of Medical Journal Editors (ICMJE). The study has been endorsed by the European Study Group for Bloodstream Infection and Sepsis (ESGBIS) and the European Study Group for Infections in Compromised Hosts (ESGICH). PMID:28115333

Is autonomic modulation different between European and Chinese astronauts?

PubMed

Liu, Jiexin; Li, Yongzhi; Verheyden, Bart; Chen, Shanguang; Chen, Zhanghuang; Gai, Yuqing; Liu, Jianzhong; Gao, Jianyi; Xie, Qiong; Yuan, Ming; Li, Qin; Li, Li; Aubert, André E

2015-01-01

The objective was to investigate autonomic control in groups of European and Chinese astronauts and to identify similarities and differences. Beat-to-beat heart rate and finger blood pressure, brachial blood pressure, and respiratory frequency were measured from 10 astronauts (five European taking part in three different space missions and five Chinese astronauts taking part in two different space missions). Data recording was performed in the supine and standing positions at least 10 days before launch, and 1, 3, and 10 days after return. Cross-correlation analysis of heart rate and systolic pressure was used to assess cardiac baroreflex modulation. A fixed breathing protocol was performed to measure respiratory sinus arrhythmia and low-frequency power of systolic blood pressure variability. Although baseline cardiovascular parameters before spaceflight were similar in all astronauts in the supine position, a significant increase in sympathetic activity and a decrease in vagal modulation occurred in the European astronauts when standing; spaceflight resulted in a remarkable vagal decrease in European astronauts only. Similar baseline supine and standing values for heart rate, mean arterial pressure, and respiratory frequency were shown in both groups. Standing autonomic control was based on a balance of higher vagal and sympathetic modulation in European astronauts. Post-spaceflight orthostatic tachycardia was observed in all European astronauts, whereas post-spaceflight orthostatic tachycardia was significantly reduced in Chinese astronauts. The basis for orthostatic intolerance is not apparent; however, many possibilities can be considered and need to be further investigated, such as genetic diversities between races, astronaut selection, training, and nutrition, etc.

Is Autonomic Modulation Different between European and Chinese Astronauts?

PubMed Central

Liu, Jiexin; Li, Yongzhi; Verheyden, Bart; Chen, Shanguang; Chen, Zhanghuang; Gai, Yuqing; Liu, Jianzhong; Gao, Jianyi; Xie, Qiong; Yuan, Ming; Li, Qin; Li, Li; Aubert, André E.

2015-01-01

Purpose The objective was to investigate autonomic control in groups of European and Chinese astronauts and to identify similarities and differences. Methods Beat-to-beat heart rate and finger blood pressure, brachial blood pressure, and respiratory frequency were measured from 10 astronauts (five European taking part in three different space missions and five Chinese astronauts taking part in two different space missions). Data recording was performed in the supine and standing positions at least 10 days before launch, and 1, 3, and 10 days after return. Cross-correlation analysis of heart rate and systolic pressure was used to assess cardiac baroreflex modulation. A fixed breathing protocol was performed to measure respiratory sinus arrhythmia and low-frequency power of systolic blood pressure variability. Results Although baseline cardiovascular parameters before spaceflight were similar in all astronauts in the supine position, a significant increase in sympathetic activity and a decrease in vagal modulation occurred in the European astronauts when standing; spaceflight resulted in a remarkable vagal decrease in European astronauts only. Similar baseline supine and standing values for heart rate, mean arterial pressure, and respiratory frequency were shown in both groups. Standing autonomic control was based on a balance of higher vagal and sympathetic modulation in European astronauts. Conclusion Post-spaceflight orthostatic tachycardia was observed in all European astronauts, whereas post-spaceflight orthostatic tachycardia was significantly reduced in Chinese astronauts. The basis for orthostatic intolerance is not apparent; however, many possibilities can be considered and need to be further investigated, such as genetic diversities between races, astronaut selection, training, and nutrition, etc. PMID:25799561

Open Lung Approach for the Acute Respiratory Distress Syndrome: A Pilot, Randomized Controlled Trial.

PubMed

Kacmarek, Robert M; Villar, Jesús; Sulemanji, Demet; Montiel, Raquel; Ferrando, Carlos; Blanco, Jesús; Koh, Younsuck; Soler, Juan Alfonso; Martínez, Domingo; Hernández, Marianela; Tucci, Mauro; Borges, Joao Batista; Lubillo, Santiago; Santos, Arnoldo; Araujo, Juan B; Amato, Marcelo B P; Suárez-Sipmann, Fernando

2016-01-01

The open lung approach is a mechanical ventilation strategy involving lung recruitment and a decremental positive end-expiratory pressure trial. We compared the Acute Respiratory Distress Syndrome network protocol using low levels of positive end-expiratory pressure with open lung approach resulting in moderate to high levels of positive end-expiratory pressure for the management of established moderate/severe acute respiratory distress syndrome. A prospective, multicenter, pilot, randomized controlled trial. A network of 20 multidisciplinary ICUs. Patients meeting the American-European Consensus Conference definition for acute respiratory distress syndrome were considered for the study. At 12-36 hours after acute respiratory distress syndrome onset, patients were assessed under standardized ventilator settings (FIO2≥0.5, positive end-expiratory pressure ≥10 cm H2O). If Pao2/FIO2 ratio remained less than or equal to 200 mm Hg, patients were randomized to open lung approach or Acute Respiratory Distress Syndrome network protocol. All patients were ventilated with a tidal volume of 4 to 8 ml/kg predicted body weight. From 1,874 screened patients with acute respiratory distress syndrome, 200 were randomized: 99 to open lung approach and 101 to Acute Respiratory Distress Syndrome network protocol. Main outcome measures were 60-day and ICU mortalities, and ventilator-free days. Mortality at day-60 (29% open lung approach vs. 33% Acute Respiratory Distress Syndrome Network protocol, p = 0.18, log rank test), ICU mortality (25% open lung approach vs. 30% Acute Respiratory Distress Syndrome network protocol, p = 0.53 Fisher's exact test), and ventilator-free days (8 [0-20] open lung approach vs. 7 [0-20] d Acute Respiratory Distress Syndrome network protocol, p = 0.53 Wilcoxon rank test) were not significantly different. Airway driving pressure (plateau pressure - positive end-expiratory pressure) and PaO2/FIO2 improved significantly at 24, 48 and 72 hours in patients in open lung approach compared with patients in Acute Respiratory Distress Syndrome network protocol. Barotrauma rate was similar in both groups. In patients with established acute respiratory distress syndrome, open lung approach improved oxygenation and driving pressure, without detrimental effects on mortality, ventilator-free days, or barotrauma. This pilot study supports the need for a large, multicenter trial using recruitment maneuvers and a decremental positive end-expiratory pressure trial in persistent acute respiratory distress syndrome.

A Modified Protocol for Color Vision Screening Using Ishihara.

PubMed

Chorley, Adrian C

2015-08-01

The Ishihara plates are commonly used as an initial occupational screening test for color vision. While effective at detecting red-green deficiencies, the color deficient subject can learn the test using different techniques. Some medical standards such as the European Aviation Safety Agency (EASA) require plate randomization and apply a stricter pass/fail requirement than suggested by Ishihara. This has been reported to increase the false positive rate up to ∼50%. Two modifications to the Ishihara protocol are investigated. These involved allowing subjects a second attempt where one or two reading errors were made and the presentation of rotated Ishihara plates. A reduction of false positive rate to 5.9% was found. Correct identification of certain rotated Ishihara plates was not affected. By using a modified Ishihara protocol, fewer color normal subjects would require unnecessary advanced color vision examination. Further, additional safeguards would be in place to ensure that no subject with a color vision deficiency could pass the Ishihara test.

Ground-Based Optical Measurements at European Flux Sites: A Review of Methods, Instruments and Current Controversies

PubMed Central

Balzarolo, Manuela; Anderson, Karen; Nichol, Caroline; Rossini, Micol; Vescovo, Loris; Arriga, Nicola; Wohlfahrt, Georg; Calvet, Jean-Christophe; Carrara, Arnaud; Cerasoli, Sofia; Cogliati, Sergio; Daumard, Fabrice; Eklundh, Lars; Elbers, Jan A.; Evrendilek, Fatih; Handcock, Rebecca N.; Kaduk, Joerg; Klumpp, Katja; Longdoz, Bernard; Matteucci, Giorgio; Meroni, Michele; Montagnani, Lenoardo; Ourcival, Jean-Marc; Sánchez-Cañete, Enrique P.; Pontailler, Jean-Yves; Juszczak, Radoslaw; Scholes, Bob; Martín, M. Pilar

2011-01-01

This paper reviews the currently available optical sensors, their limitations and opportunities for deployment at Eddy Covariance (EC) sites in Europe. This review is based on the results obtained from an online survey designed and disseminated by the Co-cooperation in Science and Technology (COST) Action ESO903—“Spectral Sampling Tools for Vegetation Biophysical Parameters and Flux Measurements in Europe” that provided a complete view on spectral sampling activities carried out within the different research teams in European countries. The results have highlighted that a wide variety of optical sensors are in use at flux sites across Europe, and responses further demonstrated that users were not always fully aware of the key issues underpinning repeatability and the reproducibility of their spectral measurements. The key findings of this survey point towards the need for greater awareness of the need for standardisation and development of a common protocol of optical sampling at the European EC sites. PMID:22164055

Antithrombotic therapy in anticoagulated patients with atrial fibrillation presenting with acute coronary syndromes and/or undergoing percutaneous coronary intervention/stenting.

PubMed

Wrigley, Benjamin J; Tapp, Luke D; Shantsila, Eduard; Lip, Gregory Yh

2010-07-01

The management of antithrombotic therapy in atrial fibrillation patients presenting with acute coronary syndrome and/or undergoing percutaneous coronary inter vention/stenting cannot be done according to a regimented common protocol, and stroke and bleeding risk stratification schema should be employed to individualize treatment options. A delicate balance is needed between the prevention of thromboembolism, against recurrent cardiac ischemia or stent thrombosis, and bleeding risk. New guidance from a consensus document of the European Society of Cardiology Working Group on Thrombosis, endorsed by the European Heart Rhythm Association and the European Association of Percutaneous Cardiovascular Interventions on the management of Antithrombotic Therapy in Atrial Fibrillation Patients Presenting with Acute Coronary Syndrome and/or Undergoing Percutaneous Coronary Intervention/Stenting has sought to clarify some of the major issues and problems surrounding this practice, and will allow clinicians to make much more informed decisions when faced with treating such patients.

The effect of cone beam CT (CBCT) on therapeutic decision-making in endodontics

PubMed Central

Knutsson, K; Flygare, L

2014-01-01

Objectives: The aim was to assess to what extent cone beam CT (CBCT) used in accordance with current European Commission guidelines in a normal clinical setting has an impact on therapeutic decisions in a population referred for endodontic problems. Methods: The study includes data of consecutively examined patients collected from October 2011 to December 2012. From 2 different endodontic specialist clinics, 57 patients were referred for a CBCT examination using criteria in accordance with current European guidelines. The CBCT examinations were performed using similar equipment and standardized among clinics. After a thorough clinical examination, but before CBCT, the examiner made a preliminary therapy plan which was recorded. After the CBCT examination, the same examiner made a new therapy plan. Therapy plans both before and after the CBCT examination were plotted for 53 patients and 81 teeth. As four patients had incomplete protocols, they were not included in the final analysis. Results: 4% of the patients referred to endodontic clinics during the study period were examined with CBCT. The most frequent reason for referral to CBCT examination was to differentiate pathology from normal anatomy, this was the case in 24 patients (45% of the cases). The primary outcome was therapy plan changes that could be attributed to CBCT examination. There were changes in 28 patients (53%). Conclusions: CBCT has a significant impact on therapeutic decision efficacy in endodontics when used in concordance with the current European Commission guidelines. PMID:24766060

Prospective multicentre PCR-based Aspergillus DNA screening in high-risk patients with and without primary antifungal mould prophylaxis.

PubMed

Springer, J; Lackner, M; Nachbaur, D; Girschikofsky, M; Risslegger, B; Mutschlechner, W; Fritz, J; Heinz, W J; Einsele, H; Ullmann, A J; Löffler, J; Lass-Flörl, C

2016-01-01

Invasive aspergillosis (IA) is associated with significant morbidity and mortality, and, among other factors, this is due to a delay in diagnosis performed with conventional techniques. A prospective, multicentre study was conducted to evaluate the efficacy of Aspergillus DNA screening in the early diagnosis of IA. Patients undergoing haematopoietic stem cell transplantation or chemotherapy for acute leukaemia were enrolled for biomarker screening. Three centres applied the same protocol for in-house PCR, which was compliant with the European Aspergillus PCR Initiative recommendations, to guarantee the highest diagnostic standards. Two thousand one hundred and twenty-eight sera from 213 patients were investigated and stratified according to the revised European Organization for the Research and Treatment of Cancer/Mycoses Study Group criteria for invasive fungal disease. The incidence rates of probable and possible IA were 18% and 38%, respectively. The sensitivity, specificity and positive predictive value (PPV) of PCR were superior in antifungal drug-naive patients, being 71.4%, 92.3%, and 62.5%, respectively. The last of these key performance indicators (PPV) was moderate in patients receiving primary prophylaxis, at 5.4%. Negative predictive values for both strategies applied were 100% with and 98.3% without antifungal mould prophylaxis. PCR has the potential to play a decisive role in the diagnosis and management of Aspergillus infections in centres not applying primary antifungal mould prophylaxis. Copyright © 2015 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

Virtual laboratories: new opportunities for collaborative water science

NASA Astrophysics Data System (ADS)

Ceola, Serena; Arheimer, Berit; Bloeschl, Guenter; Baratti, Emanuele; Capell, Rene; Castellarin, Attilio; Freer, Jim; Han, Dawei; Hrachowitz, Markus; Hundecha, Yeshewatesfa; Hutton, Christopher; Lindström, Goran; Montanari, Alberto; Nijzink, Remko; Parajka, Juraj; Toth, Elena; Viglione, Alberto; Wagener, Thorsten

2015-04-01

Reproducibility and repeatability of experiments are the fundamental prerequisites that allow researchers to validate results and share hydrological knowledge, experience and expertise in the light of global water management problems. Virtual laboratories offer new opportunities to enable these prerequisites since they allow experimenters to share data, tools and pre-defined experimental procedures (i.e. protocols). Here we present the outcomes of a first collaborative numerical experiment undertaken by five different international research groups in a virtual laboratory to address the key issues of reproducibility and repeatability. Moving from the definition of accurate and detailed experimental protocols, a rainfall-runoff model was independently applied to 15 European catchments by the research groups and model results were collectively examined through a web-based discussion. We found that a detailed modelling protocol was crucial to ensure the comparability and reproducibility of the proposed experiment across groups. Our results suggest that sharing comprehensive and precise protocols and running the experiments within a controlled environment (e.g. virtual laboratory) is as fundamental as sharing data and tools for ensuring experiment repeatability and reproducibility across the broad scientific community and thus advancing hydrology in a more coherent way.

Comparison of PCR methods for the detection of genetic variants of carp edema virus.

PubMed

Adamek, Mikolaj; Matras, Marek; Jung-Schroers, Verena; Teitge, Felix; Heling, Max; Bergmann, Sven M; Reichert, Michal; Way, Keith; Stone, David M; Steinhagen, Dieter

2017-09-20

The infection of common carp and its ornamental variety, koi, with the carp edema virus (CEV) is often associated with the occurrence of a clinical disease called 'koi sleepy disease'. The disease may lead to high mortality in both koi and common carp populations. To prevent further spread of the infection and the disease, a reliable detection method for this virus is required. However, the high genetic variability of the CEV p4a gene used for PCR-based diagnostics could be a serious obstacle for successful and reliable detection of virus infection in field samples. By analysing 39 field samples from different geographical origins obtained from koi and farmed carp and from all 3 genogroups of CEV, using several recently available PCR protocols, we investigated which of the protocols would allow the detection of CEV from all known genogroups present in samples from Central European carp or koi populations. The comparison of 5 different PCR protocols showed that the PCR assays (both end-point and quantitative) developed in the Centre for Environment, Fisheries and Aquaculture Science exhibited the highest analytical inclusivity and diagnostic sensitivity. Currently, this makes them the most suitable protocols for detecting viruses from all known CEV genogroups.

Hydrofluorocarbon (HFC) Scenarios, Climate Effects and the Montreal Protocol

NASA Astrophysics Data System (ADS)

Velders, G. J. M.; Fahey, D. W.; Daniel, J. S.

2016-12-01

The Montreal Protocol has reduced the use of ozone-depleting substances by more than 95% from its peak levels in the 1980s. As a direct result the use of hydrofluorocarbons (HFCs) as substitute compounds has increased significantly. National regulations to limit HFC use have been adopted recently in the European Union, Japan and USA, and four proposals have been submitted to amend the Montreal Protocol to substantially reduce growth in HFC use. The Parties of the Montreal Protocol have discussed these proposals during their meetings in 2016. The effects of the national regulations and Montreal Protocol amendment proposals on climate forcings and surface temperatures will be presented. Global scenarios of HFC emissions reach 4.0-5.3 GtCO2-eq yr-1 in 2050, which corresponds to a projected growth from 2015 to 2050 which is 9% to 29% of that for CO2 over the same time period. In 2050, in percent of global HFC emissions, China ( 30%), India and the rest of Asia ( 25%), Middle East and northern Africa ( 10%), and USA ( 10%) are the principal source regions; and refrigeration and stationary air conditioning are the major use sectors. Calculated baseline emissions are reduced by 90% in 2050 by implementing the North America Montreal Protocol amendment proposal. This corresponds to a reduction in surface temperature attributed to HFCs from 0.1 oC to 0.04 oC in 2050 and from 0.3-0.4 oC to 0.02 oC in 2100.

European multicentre double-blind placebo-controlled trial of Nilvadipine in mild-to-moderate Alzheimer's disease-the substudy protocols: NILVAD frailty; NILVAD blood and genetic biomarkers; NILVAD cerebrospinal fluid biomarkers; NILVAD cerebral blood flow.

PubMed

Meulenbroek, Olga; O'Dwyer, Sarah; de Jong, Daan; van Spijker, Gerrita; Kennelly, Sean; Cregg, Fiona; Olde Rikkert, Marcel; Abdullah, Laila; Wallin, Anders; Walsh, Cathal; Coen, Robert; Kenny, Rose Anne; Daly, Leslie; Segurado, Ricardo; Borjesson-Hanson, Anne; Crawford, Fiona; Mullan, Michael; Lucca, Ugo; Banzi, Rita; Pasquier, Florence; Breuilh, Laetitia; Riepe, Matthias; Kalman, Janos; Molloy, William; Tsolaki, Magda; Howard, Robert; Adams, Jessica; Gaynor, Siobhan; Lawlor, Brian

2016-07-19

In conjunction with the NILVAD trial, a European Multicentre Double-Blind Placebo Controlled trial of Nilvadipine in Mild-to-Moderate Alzheimer's disease (AD), there are four NILVAD substudies in which eligible NILVAD patients are also invited to participate. The main NILVAD protocol was previously published in BMJ Open (2014). The objectives of the NILVAD substudies are to determine whether frailty, cerebrospinal fluid (CSF), blood biomarker profile and Apolipoprotein E (APOE) status predict response to Nilvadipine, and to investigate the effect of Nilvadipine on cerebral blood flow and blood biomarkers. All participants who fulfil criteria for the main NILVAD study are eligible for participation in the NILVAD substudies. Participation is subject to informed consent and whether the substudy is available at a particular NILVAD study site. Each substudy entails extra measurements during the course of the main NILVAD study. For example, in the blood and genetic biomarkers substudy, extra blood (30 mL) will be collected at week 0, week 13, week 52 and week 78, while in the cerebral blood flow substudy, participants will receive an MRI and transcranial Doppler measurements at week 0, week 26 and week 78. In the CSF substudy, 10 mL CSF is collected at week 0 and week 78. All NILVAD substudies and all subsequent amendments have received ethical approval within each participating country, according to national regulations. Each participant provides written consent to participate. All participants remain anonymised throughout and the results of each substudy will be published in an international peer reviewed journal. EUDRACT 2012-002764-27; Pre-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Determinants of health and disability in ageing population: the COURAGE in Europe Project (collaborative research on ageing in Europe).

PubMed

Leonardi, Matilde; Chatterji, Somnath; Koskinen, Seppo; Ayuso-Mateos, Jose Luis; Haro, Josep Maria; Frisoni, Giovanni; Frattura, Lucilla; Martinuzzi, Andrea; Tobiasz-Adamczyk, Beata; Gmurek, Michal; Serrano, Ramon; Finocchiaro, Carla

2014-01-01

COURAGE in Europe was a 3-year project involving 12 partners from four European countries and the World Health Organization. It was inspired by the pressing need to integrate international studies on disability and ageing in light of an innovative perspective based on a validated data-collection protocol. COURAGE in Europe Project collected data on the determinants of health and disability in an ageing population, with specific tools for the evaluation of the role of the built environment and social networks on health, disability, quality of life and well-being. The main survey was conducted by partners in Finland, Poland and Spain where the survey has been administered to a sample of 10,800 persons, which was completed in March 2012. The newly developed and validated COURAGE Protocol for Ageing Studies has proven to be a valid tool for collecting comparable data in ageing population, and the COURAGE in Europe Project has created valid and reliable scientific evidence, demonstrating cross-country comparability, for disability and ageing research and policy development. It is therefore recommended that future studies exploring determinants of health and disability in ageing use the COURAGE-derived methodology. COURAGE in Europe Project collected data on the determinants of health and disability in an ageing population, with specific tools for the evaluation of the role of built environment and social networks on health, disability quality of life and well-being. The COURAGE Protocol for Ageing Studies has proven to be a valid tool for collecting comparable data in the ageing population. The COURAGE in Europe Consortium recommends that future studies exploring determinants of health and disability in ageing use COURAGE-derived methodology. Copyright © 2013 John Wiley & Sons, Ltd.

A pilot study of the efficacy of wipes containing chlorhexidine 0.3%, climbazole 0.5% and Tris-EDTA to reduce Malassezia pachydermatis populations on canine skin.

PubMed

Cavana, Paola; Peano, Andrea; Petit, Jean-Yanique; Tizzani, Paolo; Perrot, Sébastien; Bensignor, Emmanuel; Guillot, Jacques

2015-08-01

Wipes containing chlorhexidine and azole derivates have been recommended for veterinary use. No study has been published about their activity against Malassezia pachydermatis. To evaluate the in vivo and in vitro activity of wipes soaked in a chlorhexidine, climbazole and Tris-EDTA solution against Malassezia pachydermatis. Five research colony shar-pei dogs. Wipes were applied once daily onto the left axilla, left groin and perianal area (protocol A), and twice daily on the right axilla, right groin and umbilical region (protocol B) for 3 days. In vivo activity was evaluated by quantifying Malassezia colonies through contact plates on the selected body areas before and after wipe application. The activity of the solution in which the wipes were soaked was assessed in vitro by contact tests following the European Standard UNI EN 1275 guidelines. Samples collected after wipe application showed a significant and rapid reduction of Malassezia yeast CFU. No significant difference in the Malassezia reduction was found between protocols A and B. In vitro assay showed 100% activity against Malassezia yeasts after a 15 min contact time with the wipe solution. Wipes containing chlorhexidine, climbazole and Tris-EDTA substantially reduced the M. pachydermatis population on the skin of dogs. The results, although this was an uncontrolled study performed on a small number of dogs, suggest that these wipes may be useful for topical therapy of Malassezia dermatitis involving the lips, paws, perianal area and skin folds. © 2015 ESVD and ACVD.

Management of elderly patients with glioblastoma-multiforme-a systematic review.

PubMed

Almadani, Asmaa; Sanjay, Dixit; Chris, Rowland-Hill; Shailendra, Achawal; Chitoor, Rajaraman; Gerry, O'Reilly; Robin, Highley; Masood, Hussain; Louise, Baker; Lynne, Gill; Holly, Morris; Mohan, Hingorani

2018-03-09

The management of elderly patients with glioblastoma-multiforme (GBM) remains poorly defined with many experts in the past advocating best supportive care, in view of limited evidence on efficacy of more aggressive treatment protocols. There is randomised evidence (NORDIC and NA-O8 studies) to support the use of surgery followed by adjuvant monotherapy with either radiotherapy (RT) using hypofractionated regimes (e.g. 36 Gy in 6 fractions OR 40 Gy in 15 fractions) or chemotherapy with temozolomide (TMZ) in patients expressing methylation of promoter for O 6 -methylguanine-DNA methyltransferase enzyme. However, the role of combined-modality therapy involving the use of combined RT and TMZ protocols has remained controversial with data from the EORTC (European Organisation for Research and Treatment of Cancer)-NCIC (National Cancer Institute of Canada) studies indicating that patients more than 65 years of age may not benefit significantly from combining standard RT fractionation using 60 Gy in 30 fractions with concurrent and adjuvant TMZ. More recently, randomised data has emerged on combining hypofractionated RT with concurrent and adjuvant TMZ. We provide a comprehensive review of literature with the aim of defining an evidence-based algorithm for management of elderly glioblastoma-multiforme population.

Socioeconomic factors and childhood overweight in Europe: results from the multi-centre IDEFICS study.

PubMed

Bammann, K; Gwozdz, W; Lanfer, A; Barba, G; De Henauw, S; Eiben, G; Fernandez-Alvira, J M; Kovács, E; Lissner, L; Moreno, L A; Tornaritis, M; Veidebaum, T; Pigeot, I

2013-02-01

What is already known about this subject Overweight and obesity can be linked to different parental socioeconomic factors already in very young children. In Western developed countries, the association of childhood overweight and obesity and parental socioeconomic status shows a negative gradient. Ambiguous results have been obtained regarding the association between socioeconomic factors and childhood overweight and obesity in different countries and over time. What this study adds European regions show heterogeneous associations between socioeconomic factors and overweight and obesity in a multi-centre study with highly standardized study protocol. The strength of association between SES and overweight and obesity varies across European regions. In our study, the SES gradient is correlated with the regional mean income and the country-specific Human development index indicating a strong influence not only of the family but also of region and country on the overweight and obesity prevalence. To assess the association between different macro- and micro-level socioeconomic factors and childhood overweight. Data from the IDEFICS baseline survey is used to investigate the cross-sectional association between socioeconomic factors, like socioeconomic status (SES), and the prevalence of childhood overweight. Differences and similarities regarding this relationship in eight European regions (located in Belgium, Cyprus, Estonia, Germany, Hungary, Italy, Spain and Sweden) are explored. 11 994 children (50.9% boys, 49.1% girls) and their parents were included in the analyses. In five of the eight investigated regions (in Belgium, Estonia, Germany, Spain and Sweden), the prevalence of childhood overweight followed an inverse SES gradient. In the other three regions (in Cyprus, Hungary and Italy), no association between SES and childhood overweight was found. The SES-overweight association in a region was best explained by the country-specific human development index and the centre-specific mean income. For the investigated association between other socioeconomic factors and overweight, no clear pattern could be found in the different regions. The association between socioeconomic factors and childhood overweight was shown to be heterogeneous across different European regions. Further research on nationwide European data is needed to confirm the results and to identify target groups for prevention. © 2012 The Authors. Pediatric Obesity © 2012 International Association for the Study of Obesity.

Role of Electronic Data Exchange in an International Outbreak Caused by Salmonella enterica Serotype Typhimurium DT204b

PubMed Central

Lindsay, Elizabeth A.; Lawson, Andrew J.; Walker, Rachel A.; Ward, Linda R.; Smith, Henry R.; Scott, Fiona W.; O'Brien, Sarah J.; Fisher, Ian S.T.; Crook, Paul D.; Wilson, Deborah; Brown, Derek J; Hardardottir, Hjordis; Wannet, Wim J.B.; Tschäpe, Helmut

2002-01-01

From July through September 2000, patients in five European countries were infected with a multidrug-resistant strain of Salmonella Typhimurium DT204b. Epidemiologic investigations were facilitated by the transmission of electronic images (Tagged Image Files) of pulsed-field gel electrophoresis profiles. This investigation highlights the importance of standardized protocols for molecular typing in international outbreaks of foodborne disease. PMID:12095445

Reference standard space hippocampus labels according to the European Alzheimer's Disease Consortium-Alzheimer's Disease Neuroimaging Initiative harmonized protocol: Utility in automated volumetry.

PubMed

Wolf, Dominik; Bocchetta, Martina; Preboske, Gregory M; Boccardi, Marina; Grothe, Michel J

2017-08-01

A harmonized protocol (HarP) for manual hippocampal segmentation on magnetic resonance imaging (MRI) has recently been developed by an international European Alzheimer's Disease Consortium-Alzheimer's Disease Neuroimaging Initiative project. We aimed at providing consensual certified HarP hippocampal labels in Montreal Neurological Institute (MNI) standard space to serve as reference in automated image analyses. Manual HarP tracings on the high-resolution MNI152 standard space template of four expert certified HarP tracers were combined to obtain consensual bilateral hippocampus labels. Utility and validity of these reference labels is demonstrated in a simple atlas-based morphometry approach for automated calculation of HarP-compliant hippocampal volumes within SPM software. Individual tracings showed very high agreement among the four expert tracers (pairwise Jaccard indices 0.82-0.87). Automatically calculated hippocampal volumes were highly correlated (r L/R  = 0.89/0.91) with gold standard volumes in the HarP benchmark data set (N = 135 MRIs), with a mean volume difference of 9% (standard deviation 7%). The consensual HarP hippocampus labels in the MNI152 template can serve as a reference standard for automated image analyses involving MNI standard space normalization. Copyright © 2017 the Alzheimer's Association. Published by Elsevier Inc. All rights reserved.

Motor Cortex Stimulation in Patients Suffering from Chronic Neuropathic Pain: Summary of Expert Meeting and Premeeting Questionnaire, Combined with Literature Review.

PubMed

Kurt, Erkan; Henssen, Dylan J H A; Steegers, Monique; Staal, Michiel; Beese, Ulrich; Maarrawi, Joseph; Pirotte, Benoit; Garcia-Larrea, Luis; Rasche, Dirk; Vesper, Jan; Holsheimer, Jan; Duyvendak, Wim; Herregodts, Patrick; van Dongen, Robert; Moens, Maarten

2017-12-01

Motor cortex stimulation (MCS) was introduced in the early 1990s by Tsubokawa and his group for patients diagnosed with drug-resistant, central neuropathic pain. Inconsistencies concerning the details of this therapy and its outcomes and poor methodology of most clinical essays divide the neuromodulation society worldwide into "believers" and "nonbelievers." A European expert meeting was organized in Brussels, Belgium by the Benelux Neuromodulation Society in order to develop uniform MCS protocols in the preoperative, intraoperative, and postoperative courses. An expert meeting was organized, and a questionnaire was sent out to all the invited participants before this expert meeting. An extensive literature research was conducted in order to enrich the results. Topics that were addressed during the expert meeting were 1) inclusion and exclusion criteria, 2) targeting and methods of stimulation, 3) effects of MCS, and 4) results from the questionnaire. Substantial commonalities but also important methodologic divergencies emerged from the discussion of MCS experts from 7 European Centers. From this meeting and questionnaire, all participants concluded that there is a need for more homogenous standardized protocols for MCS regarding patient selection, implantation procedure, stimulation parameters, and follow-up-course. Copyright © 2017 Elsevier Inc. All rights reserved.

The VeTOOLS Project: an example of how to strengthen collaboration between scientists and Civil Protections in disaster risk reduction

NASA Astrophysics Data System (ADS)

Marti, Joan; Bartolini, Stefania; Becerril, Laura

2016-04-01

VeTOOLS is a project funded by the European Commission's Humanitarian Aid and Civil Protection department (ECHO), and aims at creating an integrated software platform specially designed to assess and manage volcanic risk. The project facilitates interaction and cooperation between scientists and Civil Protection Agencies in order to share, unify, and exchange procedures, methodologies and technologies to effectively reduce the impacts of volcanic disasters. The project aims at 1) improving and developing volcanic risk assessment and management capacities in active volcanic regions; 2) developing universal methodologies, scenario definitions, response strategies and alert protocols to cope with the full range of volcanic threats; 4) improving quantitative methods and tools for vulnerability and risk assessment; and 5) defining thresholds and protocols for civil protection. With these objectives, the VeTOOLS project points to two of the Sendai Framework resolutions for implementing it: i) Provide guidance on methodologies and standards for risk assessments, disaster risk modelling and the use of data; ii) Promote and support the availability and application of science and technology to decision-making, and offers a good example on how a close collaboration between science and civil protection is an effective way to contribute to DRR. European Commission ECHO Grant SI2.695524

Nephrologists' perceptions regarding dialysis withdrawal and palliative care in Europe: lessons from a European Renal Best Practice survey

PubMed Central

van Biesen, Wim; van de Luijtgaarden, Moniek W.M.; Brown, Edwina A.; Michel, Jean-Pierre; van Munster, Barbara C.; Jager, Kitty J.; van der Veer, Sabine N.

2015-01-01

Background There is a variation in dialysis withdrawal rates, but reasons for this variation across European countries are largely unknown. We therefore surveyed nephrologists' perceptions of factors concerning dialysis withdrawal and palliative care and explored relationships between these perceptions and reports of whether withdrawal actually occurred in practice. Methods We developed a 33-item electronic survey, disseminated via an email blast to all European Renal Association–European Dialysis and Transplant Association (ERA-EDTA) members. In our data analyses, we distinguished those respondents who reported occurrence from those reporting no dialysis withdrawal in their unit. With multilevel logistic regression, we investigated the association between respondents' characteristics and perceptions and whether they reported occurrence of dialysis withdrawal or not. Results Five hundred and twenty-eight nephrologists from 45 countries completed the questionnaire; 42% reported occurrence of withdrawal in their unit in the past year, and 56% perceived that stopping life-prolonging treatment in terminally ill patients was allowed. Few respondents reported presence in their unit of protocols on withdrawal decision making (7%) or palliative care (10%) or the common involvement of a geriatrician in withdrawal decisions (10%). The majority stated that palliative care had not been part of their core curriculum (74%) and that they had not recently attended continuous medical education sessions on this topic (73%). Respondents from Eastern and Southern Europe had a 42 and 40% lower probability, respectively, of reporting withdrawal compared with those from North European countries. Working in a public centre [odds ratio (OR), 2.41; 95% confidence interval (CI), 1.36–4.25] and respondents' perception that stopping life-prolonging treatment in terminally ill patients was allowed (OR, 1.96; 95% CI, 1.23–3.12), that withdrawal decisions were commonly shared between doctor and patient (OR, 1.97; 95% CI, 1.26–3.08) and that palliative care was reimbursed (OR, 1.81; 95% CI, 1.16–2.83) increased the odds of reporting occurrence of withdrawal. Conclusion Reports of dialysis withdrawal occurrence varied between European countries. Occurrence reports were more likely if respondents worked in a public centre, if stopping life-prolonging treatments was perceived as allowed, if withdrawal decisions were considered shared between doctors and patients and if reimbursement of palliative care was believed to be in place. There is room for improvement regarding protocols on withdrawal and palliative care processes and regarding nephrologists' training and education on end-of-life care. PMID:26268713

Predicting skin sensitization potential and inter-laboratory reproducibility of a human Cell Line Activation Test (h-CLAT) in the European Cosmetics Association (COLIPA) ring trials.

PubMed

Sakaguchi, Hitoshi; Ryan, Cindy; Ovigne, Jean-Marc; Schroeder, Klaus R; Ashikaga, Takao

2010-09-01

Regulatory policies in Europe prohibited the testing of cosmetic ingredients in animals for a number of toxicological endpoints. Currently no validated non-animal test methods exist for skin sensitization. Evaluation of changes in cell surface marker expression in dendritic cell (DC)-surrogate cell lines represents one non-animal approach. The human Cell Line Activation Test (h-CLAT) examines the level of CD86 and CD54 expression on the surface of THP-1 cells, a human monocytic leukemia cell line, following 24h of chemical exposure. To examine protocol transferability, between-lab reproducibility, and predictive capacity, the h-CLAT has been evaluated by five independent laboratories in several ring trials (RTs) coordinated by the European Cosmetics Association (COLIPA). The results of the first and second RTs demonstrated that the protocol was transferable and basically had good between-lab reproducibility and predictivity, but there were some false negative data. To improve performance, protocol and prediction model were modified. Using the modified prediction model in the first and second RT, accuracy was improved. However, about 15% of the outcomes were not correctly identified, which exposes some of the limitations of the assay. For the chemicals evaluated, the limitation may due to chemical being a weak allergen or having low solubility (ex. alpha-hexylcinnamaldehyde). The third RT evaluated the modified prediction model and satisfactory results were obtained. From the RT data, the feasibility of utilizing cell lines as surrogate DC in development of in vitro skin sensitization methods shows promise. The data also support initiating formal pre-validation of the h-CLAT in order to fully understand the capabilities and limitations of the assay. Copyright 2010 Elsevier Ltd. All rights reserved.

Estimation of mean glandular dose for contrast enhanced digital mammography: factors for use with the UK, European and IAEA breast dosimetry protocols

NASA Astrophysics Data System (ADS)

Dance, D. R.; Young, K. C.

2014-05-01

The UK, European and IAEA protocols for breast dosimetry in mammography use tabulations of conversion factors, which relate measurements of incident air kerma to the mean glandular dose to the breast. To supplement the existing tabulations, a Monte Carlo computer program has been used to calculate conversion factors for the high-energy spectra used for contrast enhanced digital mammography. The calculations were made for the x-ray spectra from a tungsten target (tube voltage range 40-50 kV) filtered by 0.28, 0.30 and 0.32 mm of copper, and from molybdenum and rhodium targets (tube voltage range 40-49 kV), each filtered by 0.30 mm of copper. The g-factors for all of these spectra were plotted for each breast thickness as a function of half value layer (HVL) and were found to lie on smooth curves within 0.3%. These reflect the fact that the characteristic x-rays present in the spectra from molybdenum and rhodium are heavily filtered and all the spectra are essentially Bremsstrahlung. As a consequence, the s-factor previously used in the dosimetry protocols to adjust for different target/filter combinations can be taken as unity for all of the spectra considered. Tables of g-factors and c-factors are provided for breast thicknesses in the range 20-110 mm and HVLs in the range 2.4-3.6 mm of aluminium. The tables of c-factors are given for breast glandularities in the range 0.1%-100% and for typical glandularities for women in the age bands 40-49 and 50-64 attending the UK national breast screening programme.

Intention to treat (ITT) analysis as reported in orthodontic randomized controlled trials-evaluations of methodology and recommendations for the accurate use of ITT analysis and handling dropouts.

PubMed

Bondemark, Lars; Abdulraheem, Salem

2017-10-21

To systematically evaluate in five orthodontic journals how many randomized controlled trials (RCTs) use intention to treat (ITT) analysis and to assess the methodological quality of the ITT analysis, and finally, to demonstrate in an academic way how outcomes can be affected when not implementing the ITT analysis. A search of the database, Medline, was performed via PubMed for publication type 'randomized controlled trial' published for each journal between 1 January 2013 and 30 April 2017. The five orthodontic journals assessed were the American Journal of Orthodontics and Dentofacial Orthopedics, Angle Orthodontics, European Journal of Orthodontics, Journal of Orthodontics, and Orthodontics and Craniofacial Research. Two independent reviewers assessed each RCT to determine whether the trial reported an ITT or not or if a per-protocol analysis was accomplished. The initial search generated 137 possible trials. After applying the inclusion and exclusion criteria, 90 RCTs were included and assessed. Seventeen out of 90 RCTs (18.9%) either reported an ITT analysis in the text and/or supported the ITT by flow diagrams or tables. However, six RCTs applied and reported the ITT analysis correctly, while the majority performed a per-protocol analysis instead. Nearly all the trials that applied the ITT analysis incorrectly analysed the results using a per-protocol analysis, and thus, overestimating the results and/or having a reduced sample size which then could produce a diminished statistical power. © The Author 2017. Published by Oxford University Press on behalf of the European Orthodontic Society. All rights reserved. For permissions, please email: journals.permissions@oup.com

Performance of a Blood Pressure Smartphone App in Pregnant Women: The iPARR Trial (iPhone App Compared With Standard RR Measurement).

PubMed

Raichle, Christina J; Eckstein, Jens; Lapaire, Olav; Leonardi, Licia; Brasier, Noé; Vischer, Annina S; Burkard, Thilo

2018-06-01

Hypertensive disorders are one of the leading causes of maternal death worldwide. Several smartphone apps claim to measure blood pressure (BP) using photoplethysmographic signals recorded by smartphone cameras. However, no single app has been validated for this use to date. We aimed to validate a new, promising smartphone algorithm. In this subgroup analysis of the iPARR trial (iPhone App Compared With Standard RR Measurement), we tested the Preventicus BP smartphone algorithm on 32 pregnant women. The trial was conducted based on the European Society of Hypertension International Protocol revision 2010 for validation of BP measuring devices in adults. Each individual received 7 sequential BP measurements starting with the reference device (Omron-HBP-1300) and followed by the smartphone measurement, resulting in 96 BP comparisons. Validation requirements of the European Society of Hypertension International Protocol revision 2010 were not fulfilled. Mean (±SD) systolic BP disagreement between the test and reference devices was 5.0 (±14.5) mm Hg. The number of absolute differences between test and reference device within 5, 10, and 15 mm Hg was 31, 53, and 64 of 96, respectively. A Bland-Altman plot showed an overestimation of smartphone-determined systolic BP in comparison with reference systolic BP in low range but an underestimation in medium-range BP. The Preventicus BP smartphone algorithm failed the accuracy criteria for estimating BP in pregnant women and was thus not commercialized. Pregnant women should be discouraged from using BP smartphone apps, unless there are algorithms specifically validated according to common protocols. URL: https://www.clinicaltrials.gov. Unique identifier: NCT02552030. © 2018 American Heart Association, Inc.

Striatal dopamine depletion in rats produces variable effects on contingency detection: task-related influences.

PubMed

Braun, Stephanie; Hauber, Wolfgang

2012-02-01

Dopamine (DA) depletion of the posterior dorsomedial striatum (pDMS) can impair the capability of rats to detect changes in the causal efficacy of actions. Here we sought to characterize in more detail the effects of pDMS DA depletions on contingency detection as a function of different contingency degradation training protocols. In experiment 1, sham controls and rats with pDMS DA depletions received limited contingency degradation training (4 days) that involved an invariable and high degree of degradation to one of two contingencies controlling instrumental choice behaviour. The results demonstrated that lesioned rats were insensitive to contingency manipulations both during contingency degradation training and in the subsequent extinction test. Experiment 2 further indicated that rats with pDMS DA depletion subjected to extended contingency degradation training (12 days) became sensitive to contingency manipulations during the training phase but not in the subsequent extinction test. In experiment 3, an extended but more complex contingency degradation training protocol (12 days) was used that involved a gradual shift from a low to an intermediate and a high degree of contingency degradation rather than a high and invariable degree of contingency degradation as in experiments 1 and 2. Notably, lesioned rats were sensitive to contingency manipulations both during the contingency degradation training phase and in the subsequent extinction test. Thus, pDMS DA depletions can impair the capability to detect changes in the causal efficacy of actions; however, the occurrence and pattern of impairments depend on the contingency degradation training protocol being used. © 2012 The Authors. European Journal of Neuroscience © 2012 Federation of European Neuroscience Societies and Blackwell Publishing Ltd.

Best options for the exposure of traditional and innovative moss bags: A systematic evaluation in three European countries.

PubMed

Capozzi, F; Giordano, S; Aboal, J R; Adamo, P; Bargagli, R; Boquete, T; Di Palma, A; Real, C; Reski, R; Spagnuolo, V; Steinbauer, K; Tretiach, M; Varela, Z; Zechmeister, H; Fernández, J A

2016-07-01

To develop an internationally standardized protocol for the moss bag technique application, the research team participating in the FP7 European project "MOSSclone" focused on the optimization of the moss bags exposure in terms of bag characteristics (shape of the bags, mesh size, weight/surface ratio), duration and height of exposure by comparing traditional moss bags to a new concept bag, "Mossphere". In particular, the effects of each variable on the metal uptake from the air were evaluated by a systematic experimental design carried out in urban, industrial, agricultural and background areas of three European countries with oceanic, Mediterranean and continental climate. The results evidenced that the shape, the mesh size of the bags and the exposure height (in the tested ranges), did not significantly influence the uptake capacity of the transplanted moss. The aspects more affecting the element uptake were represented by the density of the moss inside the bags and the relative ratio between its weight and the surface area of the bag. We found that, the lower the density, the higher the uptake recorded. Moreover, three weeks of exposure were not enough to have a consistent uptake signal in all the environments tested, thus we suggest an exposure period not shorter than 6 weeks, which is appropriate in most situations. The above results were confirmed in all the countries and scenarios tested. The adoption of a shared exposure protocol by the research community is strongly recommended since it is a key aspect to make biomonitoring surveys directly comparable, also in view of its recognition as a monitoring method by the EU legislation. Copyright © 2016 Elsevier Ltd. All rights reserved.

Long-term exposure to elemental constituents of particulate matter and cardiovascular mortality in 19 European cohorts: results from the ESCAPE and TRANSPHORM projects.

PubMed

Wang, Meng; Beelen, Rob; Stafoggia, Massimo; Raaschou-Nielsen, Ole; Andersen, Zorana Jovanovic; Hoffmann, Barbara; Fischer, Paul; Houthuijs, Danny; Nieuwenhuijsen, Mark; Weinmayr, Gudrun; Vineis, Paolo; Xun, Wei W; Dimakopoulou, Konstantina; Samoli, Evangelia; Laatikainen, Tiina; Lanki, Timo; Turunen, Anu W; Oftedal, Bente; Schwarze, Per; Aamodt, Geir; Penell, Johanna; De Faire, Ulf; Korek, Michal; Leander, Karin; Pershagen, Göran; Pedersen, Nancy L; Östenson, Claes-Göran; Fratiglioni, Laura; Eriksen, Kirsten Thorup; Sørensen, Mette; Tjønneland, Anne; Bueno-de-Mesquita, Bas; Eeftens, Marloes; Bots, Michiel L; Meliefste, Kees; Krämer, Ursula; Heinrich, Joachim; Sugiri, Dorothea; Key, Timothy; de Hoogh, Kees; Wolf, Kathrin; Peters, Annette; Cyrys, Josef; Jaensch, Andrea; Concin, Hans; Nagel, Gabriele; Tsai, Ming-Yi; Phuleria, Harish; Ineichen, Alex; Künzli, Nino; Probst-Hensch, Nicole; Schaffner, Emmanuel; Vilier, Alice; Clavel-Chapelon, Françoise; Declerq, Christophe; Ricceri, Fulvio; Sacerdote, Carlotta; Marcon, Alessandro; Galassi, Claudia; Migliore, Enrica; Ranzi, Andrea; Cesaroni, Giulia; Badaloni, Chiara; Forastiere, Francesco; Katsoulis, Michail; Trichopoulou, Antonia; Keuken, Menno; Jedynska, Aleksandra; Kooter, Ingeborg M; Kukkonen, Jaakko; Sokhi, Ranjeet S; Brunekreef, Bert; Katsouyanni, Klea; Hoek, Gerard

2014-05-01

Associations between long-term exposure to ambient particulate matter (PM) and cardiovascular (CVD) mortality have been widely recognized. However, health effects of long-term exposure to constituents of PM on total CVD mortality have been explored in a single study only. The aim of this study was to examine the association of PM composition with cardiovascular mortality. We used data from 19 European ongoing cohorts within the framework of the ESCAPE (European Study of Cohorts for Air Pollution Effects) and TRANSPHORM (Transport related Air Pollution and Health impacts--Integrated Methodologies for Assessing Particulate Matter) projects. Residential annual average exposure to elemental constituents within particle matter smaller than 2.5 and 10 μm (PM2.5 and PM10) was estimated using Land Use Regression models. Eight elements representing major sources were selected a priori (copper, iron, potassium, nickel, sulfur, silicon, vanadium and zinc). Cohort-specific analyses were conducted using Cox proportional hazards models with a standardized protocol. Random-effects meta-analysis was used to calculate combined effect estimates. The total population consisted of 322,291 participants, with 9545 CVD deaths. We found no statistically significant associations between any of the elemental constituents in PM2.5 or PM10 and CVD mortality in the pooled analysis. Most of the hazard ratios (HRs) were close to unity, e.g. for PM10 Fe the combined HR was 0.96 (0.84-1.09). Elevated combined HRs were found for PM2.5 Si (1.17, 95% CI: 0.93-1.47), and S in PM2.5 (1.08, 95% CI: 0.95-1.22) and PM10 (1.09, 95% CI: 0.90-1.32). In a joint analysis of 19 European cohorts, we found no statistically significant association between long-term exposure to 8 elemental constituents of particles and total cardiovascular mortality. Copyright © 2014 Elsevier Ltd. All rights reserved.

Feasibility of 2 × 24-h dietary recalls combined with a food-recording booklet, using EPIC-Soft, among schoolchildren.

PubMed

Trolle, E; Amiano, P; Ege, M; Bower, E; Lioret, S; Brants, H; Kaic-Rak, A; de Boer, E J; Andersen, L F

2011-07-01

The aim of this study was to evaluate the feasibility of the suggested trans-European methodology for undertaking representative dietary surveys among schoolchildren: 2 × 24-h dietary recalls (24-HDRs) combined with a food-recording booklet, using EPIC-Soft (the software developed to conduct 24-HDRs in the European Prospective Investigation into Cancer and Nutrition (EPIC) Study) pc-program. A total of 75 children aged 7-8 years and 70 children aged 12-13 years old were recruited through the Civil Registration System in Denmark, and 57 children aged 7-8 years and 47 children aged 12-13 years were recruited through schools in Spain. Each child with one parent completed two face-to-face 24-HDRs, combined with optional use of a food-recording booklet (FRB) to be filled in by the child, a parent or other proxy persons for preparing the recalls. Feasibility was evaluated by questionnaires completed by parents, children and interviewers, and by selected data from the 24-HDRs. The face-to-face interviews with the child and a parent together are confirmed as feasible. The children participated actively in the interviews, the oldest children being most active. The children, parents and interviewers agreed that children needed help from the parents, and that parents were of help to the child. In both countries, other proxy persons, such as teachers or the school cafeteria staff, were involved before the interview, and the majority of the parents and children reported that the FRB had been a help for the child during the interview. Further results point at specific needed improvements of the tools. The evaluated method is shown feasible in two culturally diverse European populations. However, the feasibility study also points to specific improvements of tools and data collection protocol that are strongly recommended before implementation of the method in each country of a pan-European dietary survey.

Effect and Process Evaluation of a Cluster Randomized Control Trial on Water Intake and Beverage Consumption in Preschoolers from Six European Countries: The ToyBox-Study

PubMed Central

Pinket, An-Sofie; Van Lippevelde, Wendy; De Bourdeaudhuij, Ilse; Deforche, Benedicte; Cardon, Greet; Androutsos, Odysseas; Koletzko, Berthold; Moreno, Luis A.; Socha, Piotr; Iotova, Violeta; Manios, Yannis; De Craemer, Marieke

2016-01-01

Background Within the ToyBox-study, a kindergarten-based, family-involved intervention was developed to prevent overweight and obesity in European preschoolers, targeting four key behaviours related to early childhood obesity, including water consumption. The present study aimed to examine the effect of the ToyBox-intervention (cluster randomized controlled trial) on water intake and beverage consumption in European preschoolers and to investigate if the intervention effects differed by implementation score of kindergartens and parents/caregivers. Method A sample of 4964 preschoolers (4.7±0.4 years; 51.5% boys) from six European countries (Belgium, Bulgaria, Germany, Greece, Poland, Spain) was included in the data analyses. A standardized protocol was used and parents/caregivers filled in socio-demographic data and a food-frequency questionnaire. To assess intervention effects, multilevel repeated measures analyses were conducted for the total sample and for the six country-specific samples. Based on the process evaluation questionnaire of teachers and parents/caregivers, an implementation score was constructed. To assess differences in water intake and beverage consumption by implementation score in the total sample, multilevel repeated measures analyses were performed. Results Limited intervention effects on water intake from beverages and overall beverage consumption were found. However, important results were found on prepacked fruit juice consumption, with a larger decrease in the intervention group compared to the control group. However, also a decline in plain milk consumption was found. Implementation scores were rather low in both kindergartens and parents/caregivers. Nevertheless, more favorable effects on beverage choices were found in preschoolers whose parents/caregivers and kindergarten teachers had higher implementation scores compared to those with lower implementation scores. Conclusion The ToyBox-intervention can provide the basis for the development of more tailor-made interventions. However, new strategies to improve implementation of interventions should be created. PMID:27064274

Are extraction methods in quantitative assays of pharmacopoeia monographs exhaustive? A comparison with pressurized liquid extraction.

PubMed

Basalo, Carlos; Mohn, Tobias; Hamburger, Matthias

2006-10-01

The extraction methods in selected monographs of the European and the Swiss Pharmacopoeia were compared to pressurized liquid extraction (PLE) with respect to the yield of constituents to be dosed in the quantitative assay for the respective herbal drugs. The study included five drugs, Belladonnae folium, Colae semen, Boldo folium, Tanaceti herba and Agni casti fructus. They were selected to cover different classes of compounds to be analyzed and different extraction methods to be used according to the monographs. Extraction protocols for PLE were optimized by varying the solvents and number of extraction cycles. In PLE, yields > 97 % of extractable analytes were typically achieved with two extraction cycles. For alkaloid-containing drugs, the addition of ammonia prior to extraction significantly increased the yield and reduced the number of extraction cycles required for exhaustive extraction. PLE was in all cases superior to the extraction protocol of the pharmacopoeia monographs (taken as 100 %), with differences ranging from 108 % in case of parthenolide in Tanaceti herba to 343 % in case of alkaloids in Boldo folium.

A semi-blinded study comparing 2 methods of measuring nasal potential difference: Subcutaneous needle versus dermal abrasion.

PubMed

De Wachter, E; De Schutter, I; Meulemans, A; Buyl, R; Malfroot, A

2016-01-01

According to European and US protocols, two nasal potential difference (NPD) measurement methods are considered acceptable, although they have not been formally compared: subcutaneous agar-filled needle with calomel (Ndl) and dermal abrasion with conducting cream and Ag/AgCl electrodes (Abr). We compared both in CF and healthy volunteers (HV), assessing their discriminative value and subject's preference. Twelve classic CF and 17 HV underwent both NPD methods, performed by one operator in random order. A written questionnaire, assessing preference, was completed after each test. Tracings were coded, scored in a semi-blinded fashion and categorised as CF/non-CF. 110 tracings (56 Ndl/54 Abr) were collected: 42/110 scored CF and 68/110 non-CF, showing a good correlation. No significant preference for either method was reported. Both NPD methods are similar in terms of discriminative value and subject's preference, comparing classical CF and HV. For diagnosing CF, the operator's preferred NPD-method may be used. Copyright © 2015 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.

Abrupt reversal in emissions and atmospheric abundance of HCFC-133a (CF3CH2Cl)

NASA Astrophysics Data System (ADS)

Vollmer, Martin K.; Rigby, Matt; Laube, Johannes C.; Henne, Stephan; Rhee, Tae Siek; Gooch, Lauren J.; Wenger, Angelina; Young, Dickon; Steele, L. Paul; Langenfelds, Ray L.; Brenninkmeijer, Carl A. M.; Wang, Jia-Lin; Ou-Yang, Chang-Feng; Wyss, Simon A.; Hill, Matthias; Oram, David E.; Krummel, Paul B.; Schoenenberger, Fabian; Zellweger, Christoph; Fraser, Paul J.; Sturges, William T.; O'Doherty, Simon; Reimann, Stefan

2015-10-01

Hydrochlorofluorocarbon HCFC-133a (CF3CH2Cl) is an anthropogenic compound whose consumption for emissive use is restricted under the Montreal Protocol. A recent study showed rapidly increasing atmospheric abundances and emissions. We report that, following this rise, the atmospheric abundance and emissions have declined sharply in the past three years. We find a Northern Hemisphere HCFC-133a increase from 0.13 ppt (dry-air mole fraction in parts per trillion) in 2000 to 0.50 ppt in 2012-mid-2013 followed by an abrupt drop to ˜0.44 ppt by early 2015. Global emissions derived from these observations peaked at 3.1 kt in 2011, followed by a rapid decline of ˜0.5 kt yr-2 to reach 1.5 kt yr-1 in 2014. Sporadic HCFC-133a pollution events are detected in Europe from our high-resolution HCFC-133a records at three European stations, and in Asia from samples collected in Taiwan. European emissions are estimated to be <0.1 kt yr-1 although emission hot spots were identified in France.

An European pupil project linked to the scientific aims of the experiment AQUARIUS-XENOPUS on the taxi Soyuz flight Andromede to ISS.

PubMed

Dournon, Christian; Membre, Herve; Brohm, Pierre-Eric; Coince, Aurore; Cornu, Nathalie; Dreyer, Laura; Florentin, Jonathan; Jeanneau, Lydie; Henniquin, Camille; Houbre, Marie; Guerard, Marine; Lecomte, Nathalie; Maxant, Lorie; Schluraff, Marion; Venandet, Anne-Sophie; Jusyte, Aiste; Simmet, Dana; Bocking, Dominique; Flaig, Dorothee; Santak, Leo; Bolek, Steffen; Goppel, Verena; Rossignon, Jean-Paul; Trossat, Marie-Alice; Raux, Martine; Forster, Susanne; Staudenmaier, Gerd; Boser, Sybille; Horn, Eberhard

2002-07-01

The German-French biological experiment AQUARIUS-XENOPUS which flew on the Soyuz flight Andromede to the International Space Station ISS (launched October 21, 2001 in Baikonour/Kazakhstan) was extended by an outreach project. Pupils of class 10 to 12 from Ulm/D and Nancy-Tomblaine/F studied swimming behavior of Xenopus tadpoles on ground. They were instructed to perform all experimental steps following the protocol of similar video recordings on ISS. After the flight, they evaluated the kinetics of swimming of both ground controls and space animals. The pupil project included theoretical components to introduce them to the field of gravitational biology. One feature of the project was the exchange of ideas between pupils by meetings which took place in Ulm (June 2001), Nancy (February 2002) and Paris (May 2002). We consider our approach as a successful way to include young people in space experiments on a cheap cost level and to bring ideas of gravitational biology into the curricula of European schools.

European COMPARative Effectiveness research on blended Depression treatment versus treatment-as-usual (E-COMPARED): study protocol for a randomized controlled, non-inferiority trial in eight European countries.

PubMed

Kleiboer, Annet; Smit, Jan; Bosmans, Judith; Ruwaard, Jeroen; Andersson, Gerhard; Topooco, Naira; Berger, Thomas; Krieger, Tobias; Botella, Cristina; Baños, Rosa; Chevreul, Karine; Araya, Ricardo; Cerga-Pashoja, Arlinda; Cieślak, Roman; Rogala, Anna; Vis, Christiaan; Draisma, Stasja; van Schaik, Anneke; Kemmeren, Lise; Ebert, David; Berking, Matthias; Funk, Burkhardt; Cuijpers, Pim; Riper, Heleen

2016-08-03

Effective, accessible, and affordable depression treatment is of high importance considering the large personal and economic burden of depression. Internet-based treatment is considered a promising clinical and cost-effective alternative to current routine depression treatment strategies such as face-to-face psychotherapy. However, it is not clear whether research findings translate to routine clinical practice such as primary or specialized mental health care. The E-COMPARED project aims to gain knowledge on the clinical and cost-effectiveness of blended depression treatment compared to treatment-as-usual in routine care. E-COMPARED will employ a pragmatic, multinational, randomized controlled, non-inferiority trial in eight European countries. Adults diagnosed with major depressive disorder (MDD) will be recruited in primary care (Germany, Poland, Spain, Sweden, and the United Kingdom) or specialized mental health care (France, The Netherlands, and Switzerland). Regular care for depression is compared to "blended" service delivery combining mobile and Internet technologies with face-to-face treatment in one treatment protocol. Participants will be followed up at 3, 6, and 12 months after baseline to determine clinical improvements in symptoms of depression (primary outcome: Patient Health Questionnaire-9), remission of depression, and cost-effectiveness. Main analyses will be conducted on the pooled data from the eight countries (n = 1200 in total, 150 participants in each country). The E-COMPARED project will provide mental health care stakeholders with evidence-based information and recommendations on the clinical and cost-effectiveness of blended depression treatment. France: ClinicalTrials.gov NCT02542891 . Registered on 4 September 2015; Germany: German Clinical Trials Register DRKS00006866 . Registered on 2 December 2014; The Netherlands: Netherlands Trials Register NTR4962 . Registered on 5 January 2015; Poland: ClinicalTrials.Gov NCT02389660 . Registered on 18 February 2015; Spain: ClinicalTrials.gov NCT02361684 . Registered on 8 January 2015; Sweden: ClinicalTrials.gov NCT02449447 . Registered on 30 March 2015; Switzerland: ClinicalTrials.gov NCT02410616 . Registered on 2 April 2015; United Kingdom: ISRCTN registry, ISRCTN12388725 . Registered on 20 March 2015.

A review of mammalian carcinogenicity study design and potential effects of alternate test procedures on the safety evaluation of food ingredients.

PubMed

Hayes, A W; Dayan, A D; Hall, W C; Kodell, R L; Williams, G M; Waddell, W D; Slesinski, R S; Kruger, C L

2011-06-01

Extensive experience in conducting long term cancer bioassays has been gained over the past 50 years of animal testing on drugs, pesticides, industrial chemicals, food additives and consumer products. Testing protocols for the conduct of carcinogenicity studies in rodents have been developed in Guidelines promulgated by regulatory agencies, including the US EPA (Environmental Protection Agency), the US FDA (Food and Drug Administration), the OECD (Organization for Economic Co-operation and Development) for the EU member states and the MAFF (Ministries of Agriculture, Forestries and Fisheries) and MHW (Ministry of Health and Welfare) in Japan. The basis of critical elements of the study design that lead to an accepted identification of the carcinogenic hazard of substances in food and beverages is the focus of this review. The approaches used by entities well-known for carcinogenicity testing and/or guideline development are discussed. Particular focus is placed on comparison of testing programs used by the US National Toxicology Program (NTP) and advocated in OECD guidelines to the testing programs of the European Ramazzini Foundation (ERF), an organization with numerous published carcinogenicity studies. This focus allows for a good comparison of differences in approaches to carcinogenicity testing and allows for a critical consideration of elements important to appropriate carcinogenicity study designs and practices. OECD protocols serve as good standard models for carcinogenicity testing protocol design. Additionally, the detailed design of any protocol should include attention to the rationale for inclusion of particular elements, including the impact of those elements on study interpretations. Appropriate interpretation of study results is dependent on rigorous evaluation of the study design and conduct, including differences from standard practices. Important considerations are differences in the strain of animal used, diet and housing practices, rigorousness of test procedures, dose selection, histopathology procedures, application of historical control data, statistical evaluations and whether statistical extrapolations are supported by, or are beyond the limits of, the data generated. Without due consideration, there can be result conflicting data interpretations and uncertainty about the relevance of a study's results to human risk. This paper discusses the critical elements of rodent (rat) carcinogenicity studies, particularly with respect to the study of food ingredients. It also highlights study practices and procedures that can detract from the appropriate evaluation of human relevance of results, indicating the importance of adherence to international consensus protocols, such as those detailed by OECD. Copyright © 2010. Published by Elsevier Inc.

A four-phase strategy for the implementation of reflectance confocal microscopy in dermatology.

PubMed

Hoogedoorn, L; Gerritsen, M J P; Wolberink, E A W; Peppelman, M; van de Kerkhof, P C M; van Erp, P E J

2016-08-01

Reflectance confocal microscopy (RCM) is gradually implemented in dermatology. Strategies for further implementation and practical 'hands on' guidelines are lacking. The primary outcome was to conduct a general strategy for further implementation of RCM. The secondary outcome was the diagnosis of psoriasis and differentiation of stable from unstable psoriatic plaques by means of the 'hands on' protocol, derived from the strategy. We used a four-phased model; an exploring phase, a systematic literature search, a clinical approach and, finally, an integration phase to develop a clinical guideline for RCM in psoriasis. Receiver operating characteristic curve statistics was applied to define the accuracy for the diagnosis of unstable psoriasis. A general strategy for further implementation of RCM and practical approach was developed to examine psoriasis by RCM and to distinguish stable from unstable psoriasis. Unstable psoriasis was diagnosed by epidermal inflammatory cell counts with a sensitivity and specificity of 91.7% and 98.3%, respectively, and with an accuracy of 0.92 (area under the curve). In addition, a monitoring model was proposed. This is the first study that shows a method for implementation of RCM in dermatology. The strategy and hands on protocol for psoriasis may serve as a model for other dermatological entities and additionally may lead to specialized ready-to-use RCM protocols for clinical dermatological practice. © 2016 European Academy of Dermatology and Venereology.

Exposure to major volatile organic compounds and carbonyls in European indoor environments and associated health risk.

PubMed

Sarigiannis, Dimosthenis A; Karakitsios, Spyros P; Gotti, Alberto; Liakos, Ioannis L; Katsoyiannis, Athanasios

2011-05-01

This paper summarizes recent data on the occurrence of major organic compounds (benzene, toluene, xylenes, styrene, acetaldehyde, formaldehyde, naphthalene, limonene, α-pinene and ammonia, classified by the European Commission's INDEX strategy report as the priority pollutants to be regulated) and evaluates accordingly cancer and non-cancer risks posed by indoor exposure in dwellings and public buildings in European Union (EU) countries. The review process indicated that significant differences in indoor air quality exist within and among the countries where data were available, indicating corresponding differences in sources and emission strength of airborne chemicals, identified or not. Conservative exposure limits were not exceeded for non-carcinogenic effects, except for formaldehyde; for carcinogenic agents the estimated risks were up to three orders of magnitude higher than the one (10(-6)) proposed as acceptable by risk management bodies. However, the risk assessment evaluation process faces crucial difficulties, either due to the relative paucity of indoor air quality measurements in many EU countries, or by the lack of sampling consistency in the already existing studies, indicating the need for additional measurements of indoor air quality following a harmonized sampling and analytical protocol. Additionally, uncertainties embodied in the cancer potency factors and exposure limit values impose further difficulties in substance prioritization and risk management. Copyright © 2011 Elsevier Ltd. All rights reserved.

The need for harmonisation and innovation of neuropsychological assessment in neurodegenerative dementias in Europe: consensus document of the Joint Program for Neurodegenerative Diseases Working Group.

PubMed

Costa, Alberto; Bak, Thomas; Caffarra, Paolo; Caltagirone, Carlo; Ceccaldi, Mathieu; Collette, Fabienne; Crutch, Sebastian; Della Sala, Sergio; Démonet, Jean François; Dubois, Bruno; Duzel, Emrah; Nestor, Peter; Papageorgiou, Sokratis G; Salmon, Eric; Sikkes, Sietske; Tiraboschi, Pietro; van der Flier, Wiesje M; Visser, Pieter Jelle; Cappa, Stefano F

2017-04-17

Cognitive, behavioural, and functional assessment is crucial in longitudinal studies of neurodegenerative dementias (NDD). Central issues, such as the definition of the study population (asymptomatic, at risk, or individuals with dementia), the detection of change/decline, and the assessment of relevant outcomes depend on quantitative measures of cognitive, behavioural, and functional status.Currently, we are far from having available reliable protocols and tools for the assessment of dementias in Europe. The main problems are the heterogeneity of the tools used across different European countries, the lack of standardisation of administration and scoring methods across centres, and the limited information available about the psychometric properties of many tests currently in widespread use. This situation makes it hard to compare results across studies carried out in different centres, thus hampering research progress, in particular towards the contribution to a "big data" common data set.We present here the results of a project funded by the Joint Program for Neurodegenerative Diseases (JPND) and by the Italian Ministry of Health. The project aimed at providing a consensus framework for the harmonisation of assessment tools to be applied to research in neurodegenerative disorders affecting cognition across Europe. A panel of European experts reviewed the current methods of neuropsychological assessment, identified pending issues, and made recommendations for the harmonisation of neuropsychological assessment of neurodegenerative dementias in Europe.A consensus was achieved on the general recommendations to be followed in developing procedures and tools for neuropsychological assessment, with the aim of harmonising tools and procedures to achieve more reliable data on the cognitive-behavioural examination. The results of this study should be considered as a first step to enhancing a common view and practise on NDD assessment across European countries.

Allergen immunotherapy for insect venom allergy: protocol for a systematic review.

PubMed

Dhami, Sangeeta; Nurmatov, Ulugbek; Varga, Eva-Maria; Sturm, Gunter; Muraro, Antonella; Akdis, Cezmi A; Antolín-Amérigo, Darío; Bilò, M Beatrice; Bokanovic, Danijela; Calderon, Moises A; Cichocka-Jarosz, Ewa; Elberink, Joanna N G Oude; Gawlik, Radoslaw; Jakob, Thilo; Kosnik, Mitja; Lange, Joanna; Mingomataj, Ervin; Mitsias, Dimitris I; Mosbech, Holger; Pfaar, Oliver; Pitsios, Constantinos; Pravettoni, Valerio; Roberts, Graham; Ruëff, Franziska; Sin, Betül Ayşe; Sheikh, Aziz

2015-01-01

The European Academy of Allergy and Clinical Immunology (EAACI) is in the process of developing the EAACI Guidelines for Allergen Immunotherapy (AIT) for the Management of Insect Venom Allergy. We seek to critically assess the effectiveness, cost-effectiveness and safety of AIT in the management of insect venom allergy. We will undertake a systematic review, which will involve searching international biomedical databases for published, in progress and unpublished evidence. Studies will be independently screened against pre-defined eligibility criteria and critically appraised using established instruments. Data will be descriptively and, if possible and appropriate, quantitatively synthesised. The findings from this review will be used to inform the development of recomendations for EAACI's Guidelines on AIT.

Evaluating multicenter DTI data in Huntington's disease on site specific effects: An ex post facto approach.

PubMed

Müller, Hans-Peter; Grön, Georg; Sprengelmeyer, Reiner; Kassubek, Jan; Ludolph, Albert C; Hobbs, Nicola; Cole, James; Roos, Raymund A C; Duerr, Alexandra; Tabrizi, Sarah J; Landwehrmeyer, G Bernhard; Süssmuth, Sigurd D

2013-01-01

Assessment of the feasibility to average diffusion tensor imaging (DTI) metrics of MRI data acquired in the course of a multicenter study. Sixty-one early stage Huntington's disease patients and forty healthy controls were studied using four different MR scanners at four European sites with acquisition protocols as close as possible to a given standard protocol. The potential and feasibility of averaging data acquired at different sites was evaluated quantitatively by region-of-interest (ROI) based statistical comparisons of coefficients of variation (CV) across centers, as well as by testing for significant group-by-center differences on averaged fractional anisotropy (FA) values between patients and controls. In addition, a whole-brain based statistical between-group comparison was performed using FA maps. The ex post facto statistical evaluation of CV and FA-values in a priori defined ROIs showed no differences between sites above chance indicating that data were not systematically biased by center specific factors. Averaging FA-maps from DTI data acquired at different study sites and different MR scanner types does not appear to be systematically biased. A suitable recipe for testing on the possibility to pool multicenter DTI data is provided to permit averaging of DTI-derived metrics to differentiate patients from healthy controls at a larger scale.

Primary Immune Deficiency Treatment Consortium (PIDTC) report.

PubMed

Griffith, Linda M; Cowan, Morton J; Notarangelo, Luigi D; Kohn, Donald B; Puck, Jennifer M; Pai, Sung-Yun; Ballard, Barbara; Bauer, Sarah C; Bleesing, Jack J H; Boyle, Marcia; Brower, Amy; Buckley, Rebecca H; van der Burg, Mirjam; Burroughs, Lauri M; Candotti, Fabio; Cant, Andrew J; Chatila, Talal; Cunningham-Rundles, Charlotte; Dinauer, Mary C; Dvorak, Christopher C; Filipovich, Alexandra H; Fleisher, Thomas A; Bobby Gaspar, Hubert; Gungor, Tayfun; Haddad, Elie; Hovermale, Emily; Huang, Faith; Hurley, Alan; Hurley, Mary; Iyengar, Sumathi; Kang, Elizabeth M; Logan, Brent R; Long-Boyle, Janel R; Malech, Harry L; McGhee, Sean A; Modell, Fred; Modell, Vicki; Ochs, Hans D; O'Reilly, Richard J; Parkman, Robertson; Rawlings, David J; Routes, John M; Shearer, William T; Small, Trudy N; Smith, Heather; Sullivan, Kathleen E; Szabolcs, Paul; Thrasher, Adrian; Torgerson, Troy R; Veys, Paul; Weinberg, Kenneth; Zuniga-Pflucker, Juan Carlos

2014-02-01

The Primary Immune Deficiency Treatment Consortium (PIDTC) is a network of 33 centers in North America that study the treatment of rare and severe primary immunodeficiency diseases. Current protocols address the natural history of patients treated for severe combined immunodeficiency (SCID), Wiskott-Aldrich syndrome, and chronic granulomatous disease through retrospective, prospective, and cross-sectional studies. The PIDTC additionally seeks to encourage training of junior investigators, establish partnerships with European and other International colleagues, work with patient advocacy groups to promote community awareness, and conduct pilot demonstration projects. Future goals include the conduct of prospective treatment studies to determine optimal therapies for primary immunodeficiency diseases. To date, the PIDTC has funded 2 pilot projects: newborn screening for SCID in Navajo Native Americans and B-cell reconstitution in patients with SCID after hematopoietic stem cell transplantation. Ten junior investigators have received grant awards. The PIDTC Annual Scientific Workshop has brought together consortium members, outside speakers, patient advocacy groups, and young investigators and trainees to report progress of the protocols and discuss common interests and goals, including new scientific developments and future directions of clinical research. Here we report the progress of the PIDTC to date, highlights of the first 2 PIDTC workshops, and consideration of future consortium objectives. Published by Mosby, Inc.

[Ischaemic heart disease in cancer patients. Questions and problems].

PubMed

Gulácsi-Bárdos, Petra; Szokol, Miklós; Lódi, Mária; Czuriga, Dániel; Czuriga, István; Édes, István; Nagy, András; Sármán, Balázs

2017-10-01

Cardiovascular and oncologic diseases are the causes of more than 50 percent of mortality in Europe. In 2015 oncologic and cardiovascular mortality reached 70 percent in Hungary. Patients who receive anticancer therapies are at a 2- to 7-fold greater long-term risk of acute coronary syndrome; also concomittant oncologic diseases further increase the mortality of myocardial infarction. Unfortunately there is not enough data concerning cardiovascular treatment of oncologic patients because they were excluded from most of the studies and registries. Because there is no clear protocol to treat such patients, only small studies and personal experiences could guide our medical therapies. The role of cardio-oncology is even more important, because due to the new treatments the number of tumor survivors rapidly increases. In the US more than 20 millions survivals are expected by 2025 who were treated by any kind of malignant tumors. It is not surprising that in 2014 the American Society of Cardiology declared cardio-oncology as a special and important field in cardiology, and in 2016 European Society of Cardiology released the first cardio-oncologic guideline. In this review we summarize questions and problems concerning the treatment of oncologic patient with ischaemic heart disease based on resent guidelines, published studies and local protocols. Orv Hetil. 2017; 158(43): 1691-1697.

Interoperability science cases with the CDPP tools

NASA Astrophysics Data System (ADS)

Nathanaël, J.; Cecconi, B.; André, N.; Bouchemit, M.; Gangloff, M.; Budnik, E.; Jacquey, C.; Pitout, F.; Durand, J.; Rouillard, A.; Lavraud, B.; Genot, V. N.; Popescu, D.; Beigbeder, L.; Toniutti, J. P.; Caussarieu, S.

2017-12-01

Data exchange protocols are never as efficient as when they are invisible for the end user who is then able to discover data, to cross compare observations and modeled data and finally to perform in depth analysis. Over the years these protocols, including SAMP from IVOA, EPN-TAP from the Europlanet 2020 RI community, backed by standard web-services, have been deployed in tools designed by the French Centre de Données de la Physique des Plasmas (CDPP) including AMDA, the Propagation Tool, 3DView, ... . This presentation will focus on science cases which show the capability of interoperability in the planetary and heliophysics contexts, involving both CDPP and companion tools. Europlanet 2020 RI has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No 654208.

Using electronic health records for clinical research: the case of the EHR4CR project.

PubMed

De Moor, Georges; Sundgren, Mats; Kalra, Dipak; Schmidt, Andreas; Dugas, Martin; Claerhout, Brecht; Karakoyun, Töresin; Ohmann, Christian; Lastic, Pierre-Yves; Ammour, Nadir; Kush, Rebecca; Dupont, Danielle; Cuggia, Marc; Daniel, Christel; Thienpont, Geert; Coorevits, Pascal

2015-02-01

To describe the IMI EHR4CR project which is designing and developing, and aims to demonstrate, a scalable, widely acceptable and efficient approach to interoperability between EHR systems and clinical research systems. The IMI EHR4CR project is combining and extending several previously isolated state-of-the-art technical components through a new approach to develop a platform for reusing EHR data to support medical research. This will be achieved through multiple but unified initiatives across different major disease areas (e.g. cardiovascular, cancer) and clinical research use cases (protocol feasibility, patient identification and recruitment, clinical trial execution and serious adverse event reporting), with various local and national stakeholders across several countries and therefore under various legal frameworks. An initial instance of the platform has been built, providing communication, security and terminology services to the eleven participating hospitals and ten pharmaceutical companies located in seven European countries. Proof-of-concept demonstrators have been built and evaluated for the protocol feasibility and patient recruitment scenarios. The specifications of the clinical trial execution and the adverse event reporting scenarios have been documented and reviewed. Through a combination of a consortium that brings collectively many years of experience from previous relevant EU projects and of the global conduct of clinical trials, of an approach to ethics that engages many important stakeholders across Europe to ensure acceptability, of a robust iterative design methodology for the platform services that is anchored on requirements of an underlying Service Oriented Architecture that has been designed to be scalable and adaptable, EHR4CR could be well placed to deliver a sound, useful and well accepted pan-European solution for the reuse of hospital EHR data to support clinical research studies. Copyright © 2014 Elsevier Inc. All rights reserved.

Safety and Efficacy of Day-case Percutaneous Nephrolithotomy: A Systematic Review from European Society of Uro-technology.

PubMed

Jones, Patrick; Bennett, Grace; Dosis, Alexios; Pietropaolo, Amelia; Geraghty, Robert; Aboumarzouk, Omar; Skolarikos, Andreas; Somani, Bhaskar K

2018-04-12

Day case or ambulatory percutaneous nephrolithotomy (PCNL) has risen over the last few years with the aim of discharging patients within 24h. We perform a systematic review of literature to evaluate the outcomes of day-case PCNL surgery. A Cochrane style search was performed and the following bibliographic databases were accessed: PubMed, Science Direct, Scopus, and Web of Science. This was carried out in accordance with the Preferred Reporting Items for Systematic reviews and Meta-analyses (PRISMA) guidelines. All studies in the English language reporting on PCNL patients discharged within 24h were included. Based on the literature search of 97 articles, nine (502 patients) met the inclusion criteria (mean age: 47 yr), with a mean stone size of 20.5mm. The mean operating time was 66min, and over a mean hospital stay of 17.5h, the stone-free rate was 95%. The overall complication rate was 13.5%; the vast majority of these complications were Clavien I-II complications, with a readmission rate of 3%. Day-case PCNL is a safe and feasible strategy in carefully selected cases. However, for its success, detailed planning and adherence to surgical protocol are paramount with strict criteria for inpatient admission and a thorough follow-up plan. Day-case percutaneous nephrolithotomy procedure seems to be a safe procedure with good outcomes, and low risk of complications and readmissions. Detailed preoperative protocol and planning are paramount, with indications for inpatient admission as well as a thorough follow-up plan. Copyright © 2018 European Association of Urology. Published by Elsevier B.V. All rights reserved.

EUropean prospective cohort study on Enterobacteriaceae showing REsistance to CArbapenems (EURECA): a protocol of a European multicentre observational study.

PubMed

Gutiérrez-Gutiérrez, Belén; Sojo-Dorado, Jesús; Bravo-Ferrer, José; Cuperus, Nienke; de Kraker, Marlieke; Kostyanev, Tomislav; Raka, Lul; Daikos, George; Feifel, Jan; Folgori, Laura; Pascual, Alvaro; Goossens, Herman; O'Brien, Seamus; Bonten, Marc J M; Rodríguez-Baño, Jesús

2017-04-03

The rapid worldwide spread of carbapenem-resistant Enterobacteriaceae (CRE) constitutes a major challenge. The aim of the EUropean prospective cohort study on Enterobacteriaceae showing REsistance to CArbapenems (EURECA), which is part of the Innovative Medicines Initiative Joint Undertaking (IMI JU) funded COMBACTE-CARE project, is to investigate risk factors for and outcome determinants of CRE infections to inform randomised clinical trial designs and to provide a historical cohort that could eventually be used for future comparisons with new drugs targeting CRE. A multicentre (50 sites), multinational (11 European countries), analytical observational project was designed, comprising 3 studies. The aims of study 1 (a prospective cohort study) include characterising the features, clinical management and outcomes of hospitalised patients with intra-abdominal infection, pneumonia, complicated urinary tract infections and bloodstream infections caused by CRE (202 patients in each group). The main outcomes will be 30-day all-cause mortality and clinical response. Study 2 (a nested case-control study) will identify the risk factors for target infections caused by CRE; 248 selected patients from study 1 will be matched with patients with carbapenem-susceptible Enterobacteriaceae (1:1) and with hospitalised patients (1:3) and will provide a historical cohort of patients with CRE infections. Study 3 (a matched cohort study) will follow patients in study 2 in order to assess mortality, length of stay and hospital costs associated with CRE. All patients will be followed for 30 days. Different, up-to-date statistical methods will be applied to come to unbiased estimates for all 3 studies. Before-study sites will be initiated, approval will be sought from appropriate regulatory agencies and local Ethics Committees of Research or Institutional Review Boards (IRBs) to conduct the study in accordance with regulatory requirements. This is an observational study and therefore no intervention in the diagnosis, management or treatment of the patients will be required on behalf of the investigation. Any formal presentation or publication of data collected from this study will be considered as a joint publication by the participating physician(s) and will follow the recommendations of the International Committee of Medical Journal Editors (ICMJE) for authorship. NCT02709408. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Emissions trading: principles and practice. 2nd

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

Tietenberg, T.H.

2006-02-15

The author demonstrates how emissions trading became an attractive alternative to command-and-control policies that would have required the EPA to disallow the opening of new plants in the middle of the recession-burdened 1970s. His examination of the evolution of this system includes, among other applications, the largest multinational trading system ever conceived, the European Union's Greenhouse Gas Emission Trading Scheme (EUETG), and the use of emissions trading in the Kyoto Protocol.

Stemming the Flow of Improvised Explosive Device Making Materials through Global Export Control Regimes

DTIC Science & Technology

2012-09-01

reflect the official policy or position of the Department of Defense or the U.S. Government. IRB Protocol number ______N/A______. 12a. DISTRIBUTION...Warfare DHS Department of Homeland Security DoD Department of Defense DTMF Dual-Tone Multi-Frequency EOD Explosive Ordnance Disposal EU European...Organization JMTC Joint Multinational Training Command JTF Joint Task Force MANPADS Man Portable Air Defense Systems MERC Multilateral Export Control

Mental distress and personality in women undergoing GnRH agonist versus GnRH antagonist protocols for assisted reproductive technology.

PubMed

Stenbæk, D S; Toftager, M; Hjordt, L V; Jensen, P S; Holst, K K; Bryndorf, T; Holland, T; Bogstad, J; Pinborg, A; Hornnes, P; Frokjaer, V G

2015-01-01

Do mental distress and mood fluctuations in women undergoing GnRH agonist and GnRH antagonist protocols for assisted reproductive technology (ART) differ depending on protocol and the personality trait, neuroticism? ART treatment did not induce elevated levels of mental distress in either GnRH antagonist or agonist protocols but neuroticism was positively associated with increased mental distress, independent of protocols. ART treatment may increase mental distress by mechanisms linked to sex hormone fluctuations. General psychological characteristics, such as personality traits indexing negative emotionality, e.g. neuroticism, are likely to affect mental distress during ART treatment. A total of 83 women undergoing their first ART cycle were consecutively randomized 1:1 to GnRH antagonist (n = 42) or GnRH agonist (n = 41) protocol. The study population was a subgroup of a larger ongoing Danish clinical randomized trial and was established as an add-on in the period 2010-2012. Women in the GnRH antagonist protocol received daily injections with recombinant follicle-stimulating hormone, Puregon(®) and subcutaneous injections with GnRH antagonist, Orgalutran(®). Women in the GnRH agonist protocol received nasal administration of the GnRH agonist, Synarela(®) and subcutaneous injections with FSH, Puregon(®). The study design did not allow for a blinding procedure. All women self-reported the Profile of Mood States, the Perceived Stress Scale, the Symptom Checklist-92-Revised, and the Major Depression Inventory questionnaires, at baseline, at ART cycle day 35, on the day of oocyte pick-up, and on the day of hCG testing. Also, a series of Profile of Mood States were reported daily during pharmacological treatment to monitor mood fluctuations. The personality trait Neuroticism was assessed at baseline by the self-reported NEO-PI-R questionnaire. ART did not induce within- or between-protocol changes in any of the applied measures of mental distress. However, the GnRH antagonist protocol was associated with more pronounced median mood fluctuations during the stimulation phase (antagonist, 11.0 SD, [IQR = 21.1-6.1]; agonist, 8.9 SD, [IQR = 11.3-5.7], P = 0.025). This association became non-significant after applying a Bonferroni-Holm correction. Neuroticism was highly positively associated with increased levels of mental distress throughout treatment independent of protocols (all P-values <0.006), and cross-sectional analysis revealed that women with high or low Neuroticism scores at baseline showed a significant trend towards lower chances of a positive pregnancy test (P-value =0.028). Information on prognostic factors such as preceding length of infertility, number of retrieved oocytes and number of prior insemination treatments was not accounted for in the analyses. The stratification of protocols by age in the subgroups of women included in this study was suboptimal. Women with prior or current use of antidepressant medication were excluded from our study. Our results imply that mental distress emerging during ART treatment is not causally linked to hypogonadism per se or to the choice of protocol. Rather, our data highlight the potential importance of (i) rapid increases in ovarian steroids and (ii) addressing personality traits indexing negative emotionality, i.e. Neuroticism, in women undergoing ART treatment, to optimize both emotional adjustment and, possibly, the chances of obtaining pregnancy. The Danish Research Council for Independent Research and MSD, Denmark kindly supported the study. The authors declare no competing financial interests. EudraCT - 2008-005452-24. © The Author 2014. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

User-Centered Design of Serious Games for Older Adults Following 3 Years of Experience With Exergames for Seniors: A Study Design.

PubMed

Brox, Ellen; Konstantinidis, Stathis Th; Evertsen, Gunn

2017-01-11

Seniors need sufficient balance and strength to manage in daily life, and sufficient physical activity is required to achieve and maintain these abilities. This can be a challenge, but fun and motivational exergames can be of help. However, most commercial games are not suited for this age group for several reasons. Many usability studies and user-centered design (UCD) protocols have been developed and applied, but to the best of our knowledge none of them are focusing on seniors' use of games for physical activity. In GameUp, a European cofunded project, some prototype Kinect exergames to enhance the mobility of seniors were developed in a user-centered approach. In this paper we aim to record lessons learned in 3 years of experience with exergames for seniors, considering both the needs of older adults regarding user-centered development of exergames and participation in UCD. We also provide a UCD protocol for exergames tailored to senior needs. An initial UCD protocol was formed based on literature of previous research outcomes. Senior users participated in UCD following the initial protocol. The users formed a steady group that met every second week for 3 years to play exergames and participate in the UCD during the 4 phases of the protocol. Several methods were applied in the 4 different phases of the UCD protocol; the most important methods were structured and semistructured interviews, observations, and group discussions. A total of 16 seniors with an average age above 80 years participated for 3 years in UCD in order to develop the GameUp exergames. As a result of the lessons learned by applying the different methodologies of the UCD protocol, we propose an adjusted UCD protocol providing explanations on how it should be applied for seniors as users. Questionnaires should be turned into semistructured and structured interviews while user consultation sessions should be repeated with the same theme to ensure that the UCD methods produce a valid outcome. By first following the initial and gradually the adjusted UCD protocol, the project resulted in exergame functionalities and interface features for seniors. The main lessons learned during 3 years of experience with exergames for seniors applying UCD are that devoting time to seniors is a key element of success so that trust can be gained, communication can be established, and users' opinions can be recorded. All different game elements should be taken into consideration during the design of exergames for seniors even if they seem obvious. Despite the limitations of this study, one might argue that it provides a best practice guide to the development of serious games for physical activity targeting seniors. ©Ellen Brox, Stathis Th Konstantinidis, Gunn Evertsen. Originally published in JMIR Serious Games (http://games.jmir.org), 11.01.2017.

A systematic approach for the development of a kindergarten-based intervention for the prevention of obesity in preschool age children: the ToyBox-study.

PubMed

Manios, Y; Grammatikaki, E; Androutsos, O; Chinapaw, M J M; Gibson, E L; Buijs, G; Iotova, V; Socha, P; Annemans, L; Wildgruber, A; Mouratidou, T; Yngve, A; Duvinage, K; de Bourdeaudhuij, I

2012-03-01

The increasing childhood obesity epidemic calls for appropriate measures and effective policies to be applied early in life. Large-scale socioecological frameworks providing a holistic multifactorial and cost-effective approach necessary to support obesity prevention initiatives in this age are however currently missing. To address this missing link, ToyBox-study aims to build and evaluate a cost-effective kindergarten-based, family-involved intervention scheme to prevent obesity in early childhood, which could potentially be expanded on a pan-European scale. A multidisciplinary team of researchers from 10 countries have joined forces and will work to realize this according to a systematic stepwise approach that combines the use of the PRECEDE-PROCEED model and intervention mapping protocol. ToyBox-study will conduct systematic and narrative reviews, secondary data analyses, focus group research and societal assessment to design, implement and evaluate outcome, impact, process and cost effectiveness of the intervention. This is the first time that such a holistic approach has been used on a pan-European scale to promote healthy weight and healthy energy balance-related behaviours for the prevention of early childhood obesity. The results of ToyBox-study will be disseminated among key stakeholders including researchers, policy makers, practitioners and the general population. © 2012 The Authors. obesity reviews © 2012 International Association for the Study of Obesity.

National Food, Nutrition, and Physical Activity Survey of the Portuguese General Population (2015-2016): Protocol for Design and Development.

PubMed

Lopes, Carla; Torres, Duarte; Oliveira, Andreia; Severo, Milton; Guiomar, Sofia; Alarcão, Violeta; Ramos, Elisabete; Rodrigues, Sara; Vilela, Sofia; Oliveira, Luísa; Mota, Jorge; Teixeira, Pedro J; Nicola, Paulo J; Soares, Simão; Andersen, Lene Frost

2018-02-15

The assessment of food consumption data using harmonized methodologies at the European level is fundamental to support the development of public policies. Portugal is one of the countries with the most outdated information on individual food consumption. The objective of this study was to describe the design and methodology of the National Food, Nutrition and Physical Activity Survey, 2015-2016, developed to collect national and regional data on dietary habits, physical activity (PA), and nutritional status, in a representative sample of the Portuguese general population (3 months-84 years). Participants were selected by multistage sampling, using the National Heath Registry as the sampling frame. Data collection, during 12 months, was harmonized according to European guidelines (EU-MENU, European Food Safety Authority [EFSA]). Computer-assisted personal interviewing (CAPI) was performed on a specific electronic platform synchronized with nutritional composition data and considering the FoodEx2 classification system. Dietary assessment was performed using 24-hour recalls (two nonconsecutive, 8-15 days apart) or food diaries in the case of children aged <10 years, complemented with a food propensity questionnaire; PA data (International Physical Activity Questionnaire [IPAQ], the Activity Choice Index [ACI], and 4-days PA diaries); sociodemographic data, and other health-related data were also collected. A sample of 6553 individuals completed the first interview, and 5811 participants completed two dietary assessments. The participation rate among eligible individuals was 33.38% (6553/19,635), considering the first interview, and 29.60% (5811/19,635) for the participants with two completed interviews (about 40% in children and adolescents and 20% in elderly individuals). Results of the survey will be disseminated in national and international scientific journals during 2018-2019. The survey will assist policy planning and management of national and European health programs on the improvement of nutritional status and risk assessment related to food hazards, and the enhancement of PA. The infrastructures and data driven from this Survey are a solid basis to the development of a future national surveillance system on diet, PA, and other health behaviors reproducible over time. ©Carla Lopes, Duarte Torres, Andreia Oliveira, Milton Severo, Sofia Guiomar, Violeta Alarcão, Elisabete Ramos, Sara Rodrigues, Sofia Vilela, Luísa Oliveira, Jorge Mota, Pedro J Teixeira, Paulo J Nicola, Simão Soares, Lene Frost Andersen, The IAN-AF Consortium. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 15.02.2018.

GnRH antagonist versus long agonist protocols in IVF: a systematic review and meta-analysis accounting for patient type.

PubMed

Lambalk, C B; Banga, F R; Huirne, J A; Toftager, M; Pinborg, A; Homburg, R; van der Veen, F; van Wely, M

2017-09-01

Most reviews of IVF ovarian stimulation protocols have insufficiently accounted for various patient populations, such as ovulatory women, women with polycystic ovary syndrome (PCOS) or women with poor ovarian response, and have included studies in which the agonist or antagonist was not the only variable between the compared study arms. The aim of the current study was to compare GnRH antagonist protocols versus standard long agonist protocols in couples undergoing IVF or ICSI, while accounting for various patient populations and treatment schedules. The Cochrane Menstrual Disorders and Subfertility Review Group specialized register of controlled trials and Pubmed and Embase databases were searched from inception until June 2016. Eligible trials were those that compared GnRH antagonist protocols and standard long GnRH agonist protocols in couples undergoing IVF or ICSI. The primary outcome was ongoing pregnancy rate. Secondary outcomes were: live birth rate, clinical pregnancy rate, number of oocytes retrieved and safety with regard to ovarian hyperstimulation syndrome (OHSS). Separate comparisons were performed for the general IVF population, women with PCOS and women with poor ovarian response. Pre-planned subgroup analyses were performed for various antagonist treatment schedules. We included 50 studies. Of these, 34 studies reported on general IVF patients, 10 studies reported on PCOS patients and 6 studies reported on poor responders. In general IVF patients, ongoing pregnancy rate was significantly lower in the antagonist group compared with the agonist group (RR 0.89, 95% CI 0.82-0.96). In women with PCOS and in women with poor ovarian response, there was no evidence of a difference in ongoing pregnancy between the antagonist and agonist groups (RR 0.97, 95% CI 0.84-1.11 and RR 0.87, 95% CI 0.65-1.17, respectively). Subgroup analyses for various antagonist treatment schedules compared to the long protocol GnRH agonist showed a significantly lower ongoing pregnancy rate when the oral hormonal programming pill (OHP) pretreatment was combined with a flexible protocol (RR 0.74, 95% CI 0.59-0.91) while without OHP, the RR was 0.84, 95% CI 0.71-1.0. Subgroup analysis for the fixed antagonist schedule demonstrated no evidence of a significant difference with or without OHP (RR 0.94, 95% CI 0.79-1.12 and RR 0.94, 95% CI 0.83-1.05, respectively). Antagonists resulted in significantly lower OHSS rates both in the general IVF patients and in women with PCOS (RR 0.63, 95% CI 0.50-0.81 and RR 0.53, 95% CI 0.30-0.95, respectively). No data on OHSS was available from trials in poor responders. In a general IVF population, GnRH antagonists are associated with lower ongoing pregnancy rates when compared to long protocol agonists, but also with lower OHSS rates. Within this population, antagonist treatment prevents one case of OHSS in 40 patients but results in one less ongoing pregnancy out of every 28 women treated. Thus standard use of the long GnRH agonist treatment is perhaps still the approach of choice for prevention of premature luteinization. In couples with PCOS and poor responders, GnRH antagonists do not seem to compromise ongoing pregnancy rates and are associated with less OHSS and therefore could be considered as standard treatment. © The Author 2017. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oup.com

Facts and indicators on palliative care development in 52 countries of the WHO European region: results of an EAPC Task Force.

PubMed

Centeno, Carlos; Clark, David; Lynch, Thomas; Racafort, Javier; Praill, David; De Lima, Liliana; Greenwood, Anthony; Flores, Luis Alberto; Brasch, Simon; Giordano, Amelia

2007-09-01

The European Association for Palliative Care Task (EAPC) Force on the Development of Palliative Care in Europe was created in 2003 and the results of its work are now being reported in full, both here and in several other publications. The objective of the Task Force is to assess the degree of palliative care development in the European Region as defined by the World Health Organization (WHO). The Task Force is a collaboration between EAPC, the International Observatory on End of Life Care, Help the Hospices and the International Association for Hospice and Palliative Care. The University of Navarra have collaborated in the dissemination of results and is involved in further developments of this group. Four studies, each with different working methods, made up the study protocol: a literature review, a review of all the existing palliative care directories in Europe, a qualitative ;Eurobarometer' survey and a quantitative ;Facts Questionnaire' survey. The work of the Task Force covers the entire WHO European Region of 52 countries. In this article we present a comparative study on the development of palliative care in Europe, drawing on all four elements of the study. Different models of service delivery have been developed and implemented throughout the countries of Europe. For example, in addition to the UK, the countries of Germany, Austria, Poland and Italy have a well-developed and extensive network of hospices. The model for mobile teams or hospital support teams has been adopted in a number of countries, most notably in France. Day Centres are a development that is characteristic of the UK with hundreds of these services currently in operation. The number of beds per million inhabitants ranges between 45-75 beds in the most advanced European countries, to only a few beds in others. Estimates on the number of physicians working full time in palliative care are shown. The countries with the highest development of palliative care in their respective subregions as measured in terms of ratio of services per one million inhabitants are: Western Europe - UK (15); Central and Eastern Europe - Poland (9); Commonwealth of Independent States - Armenia (8). This paper also presents indicators on the development of palliative care based on the bibliometric analysis of scientific journals and on the vitality of the palliative care movement in each country.

A parameterization method and application in breast tomosynthesis dosimetry

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

Li, Xinhua; Zhang, Da; Liu, Bob

2013-09-15

Purpose: To present a parameterization method based on singular value decomposition (SVD), and to provide analytical parameterization of the mean glandular dose (MGD) conversion factors from eight references for evaluating breast tomosynthesis dose in the Mammography Quality Standards Act (MQSA) protocol and in the UK, European, and IAEA dosimetry protocols.Methods: MGD conversion factor is usually listed in lookup tables for the factors such as beam quality, breast thickness, breast glandularity, and projection angle. The authors analyzed multiple sets of MGD conversion factors from the Hologic Selenia Dimensions quality control manual and seven previous papers. Each data set was parameterized usingmore » a one- to three-dimensional polynomial function of 2–16 terms. Variable substitution was used to improve accuracy. A least-squares fit was conducted using the SVD.Results: The differences between the originally tabulated MGD conversion factors and the results computed using the parameterization algorithms were (a) 0.08%–0.18% on average and 1.31% maximum for the Selenia Dimensions quality control manual, (b) 0.09%–0.66% on average and 2.97% maximum for the published data by Dance et al. [Phys. Med. Biol. 35, 1211–1219 (1990); ibid. 45, 3225–3240 (2000); ibid. 54, 4361–4372 (2009); ibid. 56, 453–471 (2011)], (c) 0.74%–0.99% on average and 3.94% maximum for the published data by Sechopoulos et al. [Med. Phys. 34, 221–232 (2007); J. Appl. Clin. Med. Phys. 9, 161–171 (2008)], and (d) 0.66%–1.33% on average and 2.72% maximum for the published data by Feng and Sechopoulos [Radiology 263, 35–42 (2012)], excluding one sample in (d) that does not follow the trends in the published data table.Conclusions: A flexible parameterization method is presented in this paper, and was applied to breast tomosynthesis dosimetry. The resultant data offer easy and accurate computations of MGD conversion factors for evaluating mean glandular breast dose in the MQSA protocol and in the UK, European, and IAEA dosimetry protocols. Microsoft Excel™ spreadsheets are provided for the convenience of readers.« less

Optimisation of an analytical method and results from the inter-laboratory comparison of the migration of regulated substances from food packaging into the new mandatory European Union simulant for dry foodstuffs.

PubMed

Jakubowska, Natalia; Beldì, Giorgia; Peychès Bach, Aurélie; Simoneau, Catherine

2014-01-01

This paper presents the outcome of the development, optimisation and validation at European Union level of an analytical method for using poly(2,6-diphenyl phenylene oxide--PPPO), which is stipulated in Regulation (EU) No. 10/2011, as food simulant E for testing specific migration from plastics into dry foodstuffs. Two methods for fortifying respectively PPPO and a low-density polyethylene (LDPE) film with surrogate substances that are relevant to food contact were developed. A protocol for cleaning the PPPO and an efficient analytical method were developed for the quantification of butylhydroxytoluene (BHT), benzophenone (BP), diisobutylphthalate (DiBP), bis(2-ethylhexyl) adipate (DEHA) and 1,2-cyclohexanedicarboxylic acid, diisononyl ester (DINCH) from PPPO. A protocol for a migration test from plastics using small migration cells was also developed. The method was validated by an inter-laboratory comparison (ILC) with 16 national reference laboratories for food contact materials in the European Union. This allowed for the first time data to be obtained on the precision and laboratory performance of both migration and quantification. The results showed that the validation ILC was successful even when taking into account the complexity of the exercise. The results showed that the method performance was 7-9% repeatability standard deviation (rSD) for most substances (regardless of concentration), with 12% rSD for the high level of BHT and for DiBP at very low levels. The reproducibility standard deviation results for the 16 European Union laboratories were in the range of 20-30% for the quantification from PPPO (for the three levels of concentrations of the five substances) and 15-40% from migration experiments from the fortified plastic at 60°C for 10 days and subsequent quantification. Considering the lack of data previously available in the literature, this work has demonstrated that the validation of a method is possible both for migration from a film and for quantification into a corresponding simulant for specific migration.

Individualized treadmill and strength training for chronic stroke rehabilitation: effects of imbalance.

PubMed

Al-Jarrah, Muhammed; Shaheen, Samira; Harries, Netta; Kissani, Najib; Molteni, Franco; Bar Haim, Simona

2014-01-01

Stroke survivors often have significant walking limitations and are at high risk for falling. Treadmill training, as a rehabilitation approach in stroke survivors, and its relationship to balance ability has not been widely studied. The main goal of this study was to investigate the effectiveness of an individualized treadmill-strength training protocol on functional outcomes in chronic stroke survivors. Thirty adult participants with chronic stroke were recruited from 1 European and 4 Middle Eastern countries. Each completed 36 sessions of treadmill-strength training. The rehabilitation protocol was individualized according to each patient's cardiovascular fitness. Ten-meter walk test (10MWT), Berg Balance Scale (BBS), and 6-minute walk test (6MWT) were measured before (T0) and after training (T1) and 6 months later (T2). Paired t tests were used to test differences with training (T1 - T0) and retention after training (T2 - T1). Increases in all 3 measures from T0 to T1 were significant. There were no changes in 10MWT and BBS from T1 to T2, but 6MWT tended to increase. Separate analyses for subjects with BBS scores <41 at T0 demonstrated comparatively greater improvements from T0 to T1 than in those with BBS scores ≯40. Those with low scores also significantly increased from T1 to T2 in both walk tests. These findings suggest that a protocol combining treadmill with strength training has beneficial long-term effects on functional walking measures after chronic stroke, especially in patients who initially have low balance ability.

Update on community-acquired bacterial meningitis: guidance and challenges.

PubMed

van Ettekoven, C N; van de Beek, D; Brouwer, M C

2017-09-01

The existing heterogeneity in diagnostic work-up and treatment strategies in bacterial meningitis was the incentive to develop a European evidence-based guideline, which was published in 2016 by the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Study Group on Infections of the Brain (ESGIB). To summarize salient features of the guideline, identify recent developments and challenges currently faced. The ESCMID guideline, ongoing trial registries. Epidemiology, clinical symptoms, diagnostic work-up and therapy strategies of acute bacterial meningitis. The incidence of bacterial meningitis has decreased following pneumococcal and meningococcal conjugate vaccine introduction. In the diagnosis of bacterial meningitis the clinical characteristics and laboratory parameters are of limited diagnostic accuracy and therefore cerebrospinal fluid analysis remains the principal contributor to the final diagnosis. The ESCMID guideline advises to start empiric treatment within one hour of arrival in all suspected meningitis cases, and choice of antibiotics needs to be differentiated according to the patient's age, risk factors, and local resistance rates of pneumococci. Dexamethasone is the only proven adjunctive treatment and should be started together with the antibiotics. The follow-up of surviving patients should include evaluation for hearing loss and pneumococcal vaccination to prevent recurrences. Future perspectives include further development and implementation of vaccines, and new treatments aimed at further reducing the inflammatory response. Studies on implementation of the new guideline should determine adherence and evaluate whether improved prognosis can be achieved by following protocolled management strategies. Copyright © 2017 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

Design of a multicentre randomized controlled trial to assess the safety and efficacy of dose titration by specialized nurses in patients with heart failure. ETIFIC study protocol.

PubMed

Oyanguren, Juana; García-Garrido, LLuisa; Nebot Margalef, Magdalena; Lekuona, Iñaki; Comin-Colet, Josep; Manito, Nicolás; Roure, Julia; Ruiz Rodriguez, Pilar; Enjuanes, Cristina; Latorre, Pedro; Torcal Laguna, Jesús; García-Gutiérrez, Susana

2017-11-01

Heart failure (HF) is associated with many hospital admissions and relatively high mortality, rates decreasing with administration of beta-blockers (BBs), angiotensin-converting-enzyme inhibitors, angiotensin II receptor blockers, and mineralocorticoid receptor antagonists. The effect is dose dependent, suboptimal doses being common in clinical practice. The 2012 European guidelines recommend close monitoring and dose titration by HF nurses. Our main aim is to compare BB doses achieved by patients after 4 months in intervention (HF nurse-managed) and control (cardiologist-managed) groups. Secondary aims include comparing doses of the other aforementioned drugs achieved after 4 months, adverse events, and outcomes at 6 months in the two groups. We have designed a multicentre (20 hospitals) non-inferiority randomized controlled trial, including patients with new-onset HF, left ventricular ejection fraction ≤40%, and New York Heart Association class II-III, with no contraindications to BBs. We will also conduct qualitative analysis to explore potential barriers to and facilitators of dose titration by HF nurses. In the intervention group, HF nurses will implement titration as prescribed by cardiologists, following a protocol. In controls, cardiologists will both prescribe and titrate doses. The study variables are doses of each of the drugs after 4 months relative to the target dose (%), New York Heart Association class, left ventricular ejection fraction, N-terminal pro B-type natriuretic peptide levels, 6 min walk distance, comorbidities, renal function, readmissions, mortality, quality of life, and psychosocial characteristics. The trial seeks to assess whether titration by HF nurses of drugs recommended in practice guidelines is safe and not inferior to direct management by cardiologists. The results could have an impact on clinical practice. © 2017 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of the European Society of Cardiology.

Photobacterium damselae ssp. piscicida: detection by direct amplification of 16S rRNA gene sequences and genotypic variation as determined by amplified fragment length polymorphism (AFLP).

PubMed

Kvitt, H; Ucko, M; Colorni, A; Batargias, C; Zlotkin, A; Knibb, W

2002-04-05

A PCR protocol for the rapid diagnosis of fish 'pasteurellosis' based on 16S rRNA gene sequences was developed. The procedure combines low annealing temperature that detects low titers of Photobacterium damselae but also related species, and high annealing temperature for the specific identification of P. damselae directly from infected fish. The PCR protocol was validated on 19 piscine isolates of P. damselae ssp. piscicida from different geographic regions (Japan, Italy, Spain, Greece and Israel), on spontaneously infected sea bream Sparus aurata and sea bass Dicentrarchus labrax, and on closely related American Type Culture Collection (ATCC) reference strains. PCR using high annealing temperature (64 degrees C) discriminated between P. damselae and closely related reference strains, including P. histaminum. Sixteen isolates of P. damselae ssp. piscicida, 2 P. damselae ssp. piscicida reference strains and 1 P. damselae ssp. damselae reference strain were subjected to Amplified Fragment Length Polymorphism (AFLP) analysis, and a similarity matrix was produced. Accordingly, the Japanese isolates of P. damselae ssp. piscicida were distinguished from the Mediterranean/European isolates at a cut-off value of 83% similarity. A further subclustering at a cut-off value of 97% allowed discrimination between the Israeli P. damselae ssp. piscicida isolates and the other Mediterranean/European isolates. The combination of PCR direct amplification and AFLP provides a 2-step procedure, where P. damselae is rapidly identified at genus level on the basis of its 16S rRNA gene sequence and then grouped into distinct clusters on the basis of AFLP polymorphisms. The first step of direct amplification is highly sensitive and has immediate practical consequences, offering fish farmers a rapid diagnosis, while the AFLP is more specific and detects intraspecific variation which, in our study, also reflected geographic correspondence. Because of its superior discriminative properties, AFLP can be an important tool for epidemiological and taxonomic studies of this highly homogeneous genus.

Molecular identification key based on PCR/RFLP for three polychaete sibling species of the genus Marenzelleria, and the species' current distribution in the Baltic Sea

NASA Astrophysics Data System (ADS)

Blank, M.; Laine, A. O.; Jürss, K.; Bastrop, R.

2008-06-01

Studies of Marenzelleria species were often hampered by identification uncertainties when using morphological characters only. A newly developed PCR/RFLP protocol allows a more efficient discrimination of the three species Marenzelleria viridis, Marenzelleria neglecta and Marenzelleria arctia currently known for the Baltic Sea. The protocol is based on PCR amplification of two mitochondrial DNA gene segments (16S, COI) followed by digestion with restriction enzymes. As it is faster and cheaper than PCR/sequencing protocols used so far, the protocol is recommended for large-scale analyses. The markers allow an undoubted determination of species irrespective of life stage or condition of the worms in the samples. The protocol was validated on about 950 specimens sampled at more than 30 sites of the Baltic and the North Sea, and on specimens from populations of the North American east coast. Besides this test we used mitochondrial DNA sequences (16S, COI, Cytb) and starch gel electrophoresis to further investigate the distribution of the three Marenzelleria species in the Baltic Sea. The results show that M. viridis (formerly genetic type I or M. cf. wireni) occurred in the Öresund area, in the south western as well as in the eastern Baltic Sea, where it is found sympatric with M. neglecta. Allozyme electrophoresis indicated an introduction by range expansion from the North Sea. The second species, M. arctia, was only found in the northern Baltic Sea, where it sometimes occurred sympatric with M. neglecta or M. viridis. For Baltic M. arctia, the most probable way of introduction is by ship ballast water from the European Arctic. There is an urgent need for a new genetic analysis of all Marenzelleria populations of the Baltic Sea to unravel the current distribution of the three species.

The CERTAIN Registry: a novel, web-based registry and research platform for pediatric renal transplantation in Europe.

PubMed

Plotnicki, L; Kohl, C D; Höcker, B; Krupka, K; Rahmel, A; Pape, L; Hoyer, P; Marks, S D; Webb, N J A; Söylemezoglu, O; Topaloglu, R; Szabo, A J; Seeman, T; Marlies Cornelissen, E A; Knops, N; Grenda, R; Tönshoff, B

2013-05-01

The results of pediatric renal transplantation have improved markedly in the last decade. However, a number of relevant clinical problems remain, such as organ damage caused by chronic rejection, long-term toxicity of immunosuppressive therapy, difficulty in developing tolerance-inducing protocols, secondary cardiovascular comorbidity, post-transplantation lymphoproliferative disease, suboptimal longitudinal growth, quality of life, adherence to immunosuppressive medication, and structured transition programs to adult care. These unmet clinical needs require intense collaborative and interdisciplinary clinical research. We recently founded the Cooperative European Paediatric Renal TransplAnt INitiative (CERTAIN; www.certain-registry.eu) as a research network and platform built on a novel, web-based registry. The registry's dataset provides essential information on generic kidney transplantation-related topics and also captures pediatric-specific topics, such as growth, physical and psychosocial development, and adherence. Due to its flexibility the system can be used as follows: (1) as a registry capturing a minimal or an extended dataset; (2) as a center and/or country-specific transplantation database; or (3) as a patient-specific electronic transplantation chart. The data can be exported directly from the CERTAIN web application into statistical software packages for scientific analyses. The rights regarding data ownership, evaluation, and publications are regulated in the registry's rules of procedure. Data quality is ensured by automatic software validation and a manual data review process. To avoid redundant data entry, CERTAIN has established interfaces for data change with Eurotransplant, the Collaborative Transplant Study (CTS), and the registry of the European Society of Pediatric Nephrology (ESPN) and European Renal Association - European Dialysis and Transplant Association (ERA-EDTA) (ESPN/ERA-EDTA registry). CERTAIN fulfils all regulatory and ethical requirements of the European Union and Germany, in particular, regarding patients' data privacy and security. Using modern information technology, the recently established multinational CERTAIN Registry fills a gap in Europe for collaborative 5 research and quality assurance in the field of pediatric renal transplantation. Copyright © 2013 Elsevier Inc. All rights reserved.

Evaluation of a new very low dose imaging protocol: feasibility and impact on X-ray dose levels in electrophysiology procedures.

PubMed

Bourier, Felix; Reents, Tilko; Ammar-Busch, Sonia; Buiatti, Alessandra; Kottmaier, Marc; Semmler, Verena; Telishevska, Marta; Brkic, Amir; Grebmer, Christian; Lennerz, Carsten; Kolb, Christof; Hessling, Gabriele; Deisenhofer, Isabel

2016-09-01

This study presents and evaluates the impact of a new lowest-dose fluoroscopy protocol (Siemens AG), especially designed for electrophysiology (EP) procedures, on X-ray dose levels. From October 2014 to March 2015, 140 patients underwent an EP study on an Artis zee angiography system. The standard low-dose protocol was operated at 23 nGy (fluoroscopy) and at 120 nGy (cine-loop), the new lowest-dose protocol was operated at 8 nGy (fluoroscopy) and at 36 nGy (cine-loop). Procedural data, X-ray times, and doses were analysed in 100 complex left atrial and in 40 standard EP procedures. The resulting dose-area products were 877.9 ± 624.7 µGym² (n = 50 complex procedures, standard low dose), 199 ± 159.6 µGym² (n = 50 complex procedures, lowest dose), 387.7 ± 36.0 µGym² (n = 20 standard procedures, standard low dose), and 90.7 ± 62.3 µGym² (n = 20 standard procedures, lowest dose), P < 0.01. In the low-dose and lowest-dose groups, procedure times were 132.6 ± 35.7 vs. 126.7 ± 34.7 min (P = 0.40, complex procedures) and 72.3 ± 20.9 vs. 85.2 ± 44.1 min (P = 0.24, standard procedures), radiofrequency (RF) times were 53.8 ± 26.1 vs. 50.4 ± 29.4 min (P = 0.54, complex procedures) and 10.1 ± 9.9 vs. 12.2 ± 14.7 min (P = 0.60, standard procedures). One complication occurred in the standard low-dose and lowest-dose groups (P = 1.0). The new lowest-dose imaging protocol reduces X-ray dose levels by 77% compared with the currently available standard low-dose protocol. From an operator standpoint, lowest X-ray dose levels create a different, reduced image quality. The new image quality did not significantly affect procedure or RF times and did not result in higher complication rates. Regarding radiological protection, operating at lowest-dose settings should become standard in EP procedures. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

Aerobic vs. resistance exercise in non-alcoholic fatty liver disease: A systematic review.

PubMed

Hashida, Ryuki; Kawaguchi, Takumi; Bekki, Masafumi; Omoto, Masayuki; Matsuse, Hiroo; Nago, Takeshi; Takano, Yoshio; Ueno, Takato; Koga, Hironori; George, Jacob; Shiba, Naoto; Torimura, Takuji

2017-01-01

Exercise is a first-line therapy for patients with non-alcoholic fatty liver disease (NAFLD). We sought to: 1) summarize effective aerobic and resistance exercise protocols for NAFLD; and 2) compare the effects and energy consumption of aerobic and resistance exercises. A literature search was performed using PubMed, Web of Science, and Scopas to January 28, 2016. From a total of 95 articles, 23 studies including 24 aerobic and 7 resistance exercise protocols were selected for the summary of exercise protocols. Twelve articles including 13 aerobic and 4 resistance exercise protocols were selected for the comparative analysis. For aerobic exercise, the median effective protocol was 4.8 metabolic equivalents (METs) for 40min/session, 3times/week for 12weeks. For resistance exercise, the median effective protocol was 3.5 METs for 45min/session, 3times/week for 12weeks. Aerobic and resistance exercise improved hepatic steatosis. No significant difference was seen in the duration, frequency, or period of exercise between the two exercise groups; however, %VO 2 max and energy consumption were significantly lower in the resistance than in the aerobic group (50% [45-98] vs. 28% [28-28], p=0.0034; 11,064 [6394-21,087] vs. 6470 [4104-12,310] kcal/total period, p=0.0475). Resistance exercise improves NAFLD with less energy consumption. Thus, resistance exercise may be more feasible than aerobic exercise for NAFLD patients with poor cardiorespiratory fitness or for those who cannot tolerate or participate in aerobic exercise. These data may indicate a possible link between resistance exercise and lipid metabolism in the liver. Both aerobic and resistance exercise reduce hepatic steatosis in non-alcoholic fatty liver disease (NAFLD) with similar frequency, duration, and period of exercise (40-45min/session 3times/week for 12weeks); however, the two forms of exercise have different characteristics. Intensity and energy consumption were significantly lower for resistance than for aerobic exercise. Resistance exercise may be more feasible than aerobic exercise for NAFLD patients with poor cardiorespiratory fitness or for those who cannot tolerate or participate in aerobic exercise. Copyright © 2016 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

Impact of age on the selection of nuclear cardiology stress protocols: The INCAPS (IAEA nuclear cardiology protocols) study.

PubMed

Al-Mallah, Mouaz H; Pascual, Thomas N B; Mercuri, Mathew; Vitola, João V; Karthikeyan, Ganesan; Better, Nathan; Dondi, Maurizio; Paez, Diana; Einstein, Andrew J

2018-05-15

There is growing concern about radiation exposure from nuclear myocardial perfusion imaging (MPI), particularly among younger patients who are more prone to develop untoward effects of ionizing radiation, and hence US and European professional society guidelines recommend age as a consideration in weighing radiation risk from MPI. We aimed to determine how patient radiation doses from MPI vary across age groups in a large contemporary international cohort. Data were collected as part of a global cross-sectional study of centers performing MPI coordinated by the International Atomic Energy Agency (IAEA). Sites provided information on each MPI study completed during a single week in March-April 2013. We compared across age groups laboratory adherence to pre-specified radiation-related best practices, radiation effective dose (ED; a whole-body measure reflecting the amount of radiation to each organ and its relative sensitivity to radiation's deleterious effects), and the proportion of patients with ED ≤ 9 mSv, a target level specified in guidelines. Among 7911 patients undergoing MPI in 308 laboratories in 65 countries, mean ED was 10.0 ± 4.5 mSv with slightly higher exposure among younger age groups (trend p value < 0.001). There was no difference in the proportion of patients with ED ≤ 9 mSv across age groups, or in adherence to best practices based on the median age of patients in a laboratory. In contemporary nuclear cardiology practice, the age of the patient appears not to impact protocol selection and radiation dose, contrary to professional society guidelines. Copyright © 2018. Published by Elsevier B.V.

Space headache on Earth: head-down-tilted bed rest studies simulating outer-space microgravity.

PubMed

van Oosterhout, W P J; Terwindt, G M; Vein, A A; Ferrari, M D

2015-04-01

Headache is a common symptom during space travel, both isolated and as part of space motion syndrome. Head-down-tilted bed rest (HDTBR) studies are used to simulate outer space microgravity on Earth, and allow countermeasure interventions such as artificial gravity and training protocols, aimed at restoring microgravity-induced physiological changes. The objectives of this article are to assess headache incidence and characteristics during HDTBR, and to evaluate the effects of countermeasures. In a randomized cross-over design by the European Space Agency (ESA), 22 healthy male subjects, without primary headache history, underwent three periods of -6-degree HDTBR. In two of these episodes countermeasure protocols were added, with either centrifugation or aerobic exercise training protocols. Headache occurrence and characteristics were daily assessed using a specially designed questionnaire. In total 14/22 (63.6%) subjects reported a headache during ≥1 of the three HDTBR periods, in 12/14 (85.7%) non-specific, and two of 14 (14.4%) migraine. The occurrence of headache did not differ between HDTBR with and without countermeasures: 12/22 (54.5%) subjects vs. eight of 22 (36.4%) subjects; p = 0.20; 13/109 (11.9%) headache days vs. 36/213 (16.9%) headache days; p = 0.24). During countermeasures headaches were, however, more often mild (p = 0.03) and had fewer associated symptoms (p = 0.008). Simulated microgravity during HDTBR induces headache episodes, mostly on the first day. Countermeasures are useful in reducing headache severity and associated symptoms. Reversible, microgravity-induced cephalic fluid shift may cause headache, also on Earth. HDTBR can be used to study space headache on Earth. © International Headache Society 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

Comparing laparoscopic antireflux surgery with esomeprazole in the management of patients with chronic gastro-oesophageal reflux disease: a 3-year interim analysis of the LOTUS trial

PubMed Central

Lundell, L; Attwood, S; Ell, C; Fiocca, R; Galmiche, J-P; Hatlebakk, J; Lind, T; Junghard, O

2008-01-01

Background: With the introduction of laparoscopic antireflux surgery (LARS) for gastro-oesophageal reflux disease (GORD) along with the increasing efficacy of modern medical treatment, a direct comparison is warranted. The 3-year interim results of a randomised study comparing both the efficacy and safety of LARS and esomeprazole (ESO) are reported. Methods: LOTUS is an open, parallel-group multicentre, randomised and controlled trial conducted in dedicated centres in 11 European countries. LARS was completed according to a standardised protocol, comprising a total fundoplication and a crural repair. Medical treatment comprised ESO 20 mg once daily, which could be increased stepwise to 40 mg once daily and then 20 mg twice daily in the case of incomplete GORD control. The primary outcome variable was time to treatment failure (Kaplan–Meier analysis). Treatment failure was defined on the basis of symptomatic relapse requiring treatment beyond that stated in the protocol. Results: 554 patients were randomised, of whom 288 were allocated to LARS and 266 to ESO. The two study arms were well matched. The proportions of patients who remained in remission after 3 years were similar for the two therapies: 90% of surgical patients compared with 93% medically treated for the intention to treat population, p = 0.25 (90% vs 95% per protocol). No major unexpected postoperative complications were experienced and ESO was well tolerated. However, postfundoplication complaints remain a problem after LARS. Conclusions: Over the first 3 years of this long-term study, both laparoscopic total fundoplication and continuous ESO treatment were similarly effective and well-tolerated therapeutic strategies for providing effective control of GORD. PMID:18469091

Copenhagen study of overweight patients with coronary artery disease undergoing low energy diet or interval training: the randomized CUT-IT trial protocol.

PubMed

Pedersen, Lene Rørholm; Olsen, Rasmus Huan; Frederiksen, Marianne; Astrup, Arne; Chabanova, Elizaveta; Hasbak, Philip; Holst, Jens Juul; Kjær, Andreas; Newman, John W; Walzem, Rosemary; Wisløff, Ulrik; Sajadieh, Ahmad; Haugaard, Steen Bendix; Prescott, Eva

2013-11-19

Coronary artery disease (CAD) is accountable for more than 7 million deaths each year according to the World Health Organization (WHO). In a European population 80% of patients diagnosed with CAD are overweight and 31% are obese. Physical inactivity and overweight are major risk factors in CAD, thus central strategies in secondary prevention are increased physical activity and weight loss. In a randomized controlled trial 70 participants with stable CAD, age 45-75, body mass index 28-40 kg/m2 and no diabetes are randomized (1:1) to 12 weeks of intensive exercise or weight loss both succeeded by a 40-week follow-up. The exercise protocol consist of supervised aerobic interval training (AIT) at 85-90% of VO2peak 3 times weekly for 12 weeks followed by supervised AIT twice weekly for 40 weeks. In the weight loss arm dieticians instruct the participants in a low energy diet (800-1000 kcal/day) for 12 weeks, followed by 40 weeks of weight maintenance combined with supervised AIT twice weekly. The primary endpoint of the study is change in coronary flow reserve after the first 12 weeks' intervention. Secondary endpoints include cardiovascular, metabolic, inflammatory and anthropometric measures. The study will compare the short and long-term effects of a protocol consisting of AIT alone or a rapid weight loss followed by AIT. Additionally, it will provide new insight in mechanisms behind the benefits of exercise and weight loss. We wish to contribute to the creation of effective secondary prevention and sustainable rehabilitation strategies in the large population of overweight and obese patients diagnosed with CAD. ClinicalTrials.gov: NCT01724567.

ACTN3 R577X polymorphism and team-sport performance: a study involving three European cohorts.

PubMed

Eynon, Nir; Banting, Lauren K; Ruiz, Jonatan R; Cieszczyk, Pawel; Dyatlov, Dmitry A; Maciejewska-Karlowska, Agnieszka; Sawczuk, Marek; Pushkarev, Vladimir P; Kulikov, Leonid M; Pushkarev, Evgeny D; Femia, Pedro; Stepto, Nigel K; Bishop, David J; Lucia, Alejandro

2014-01-01

To determine the association between the α-actinin-3 (ACTN3) R577X polymorphism and elite team-sport athletic status in three cohorts of European team-sport athletes. We compared the genotype and allele frequencies of the ACTN3 R577X (rs1815739) polymorphisms between team-sport athletes (n=205), endurance athletes (n=305), sprint/power athletes (n=378), and non-athletic controls (n=568) from Poland, Russia and Spain; all participants were unrelated European men. Genomic DNA was extracted from either buccal epithelium or peripheral blood using a standard protocol. Genotyping was performed using several methods, and the results were replicated following recent recommendations for genotype-phenotype association studies. Genotype distributions of all control and athletic groups met Hardy-Weinberg equilibrium (all p>0.05). Team-sport athletes were less likely to have the 577RR genotype compared to the 577XX genotype than sprint/power athletes [odds ratio: 0.58, 95% confidence interval: 0.34-0.39, p=0.045]. However, the ACTN3 R577X polymorphism was not associated with team-sports athletic status, compared to endurance athletes and non-athletic controls. Furthermore, no association was observed for any of the genotypes with respect to the level of competition (elite vs. national level). The ACTN3 R577X polymorphism was not associated with team-sport athletic status, compared to endurance athletes and non-athletic controls, and the observation that the 577RR genotype is overrepresented in power/sprint athletes compared with team-sport athletes needs to be confirmed in future studies. Copyright © 2013 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

Absorbed dose-to-water protocol applied to synchrotron-generated x-rays at very high dose rates

NASA Astrophysics Data System (ADS)

Fournier, P.; Crosbie, J. C.; Cornelius, I.; Berkvens, P.; Donzelli, M.; Clavel, A. H.; Rosenfeld, A. B.; Petasecca, M.; Lerch, M. L. F.; Bräuer-Krisch, E.

2016-07-01

Microbeam radiation therapy (MRT) is a new radiation treatment modality in the pre-clinical stage of development at the ID17 Biomedical Beamline of the European synchrotron radiation facility (ESRF) in Grenoble, France. MRT exploits the dose volume effect that is made possible through the spatial fractionation of the high dose rate synchrotron-generated x-ray beam into an array of microbeams. As an important step towards the development of a dosimetry protocol for MRT, we have applied the International Atomic Energy Agency’s TRS 398 absorbed dose-to-water protocol to the synchrotron x-ray beam in the case of the broad beam irradiation geometry (i.e. prior to spatial fractionation into microbeams). The very high dose rates observed here mean the ion recombination correction factor, k s , is the most challenging to quantify of all the necessary corrections to apply for ionization chamber based absolute dosimetry. In the course of this study, we have developed a new method, the so called ‘current ramping’ method, to determine k s for the specific irradiation and filtering conditions typically utilized throughout the development of MRT. Using the new approach we deduced an ion recombination correction factor of 1.047 for the maximum ESRF storage ring current (200 mA) under typical beam spectral filtering conditions in MRT. MRT trials are currently underway with veterinary patients at the ESRF that require additional filtering, and we have estimated a correction factor of 1.025 for these filtration conditions for the same ESRF storage ring current. The protocol described herein provides reference dosimetry data for the associated Treatment Planning System utilized in the current veterinary trials and anticipated future human clinical trials.

WHO European Childhood Obesity Surveillance Initiative in Serbia: a prevalence of overweight and obesity among 6-9-year-old school children.

PubMed

Djordjic, Visnja; Radisavljevic, Snezana; Milanovic, Ivana; Bozic, Predrag; Grbic, Miljana; Jorga, Jagoda; Ostojic, Sergej M

2016-09-01

The World Health Organization (WHO) European Childhood Obesity Surveillance Initiative (COSI) is a public health program established in order to understand the progress of the obesity epidemic in young populations and gain inter-country comparisons within the European region, yet the data from a number of East European countries, including Serbia, were not available then. Therefore, the main aim of this cross-sectional study was to collect data about the prevalence of overweight and obesity among 6-9-year-old school children in Serbia according to the standardized protocol during the Fourth COSI Implementation Round. From September 2015 to November 2015, 5102 first- and second-grade primary-school children (age 7.7±0.6 years) were assessed for weight, height, and body mass index (BMI) in 14 Serbian school districts. The prevalence rates of obesity, as calculated using the International Obesity Task Force (IOTF) cut-off points, vary across different age groups, with the lowest obesity rates reported in 7-year-old boys (6.2%), while the highest obesity prevalence rates were observed in 6-year-old boys (9.7%). In addition, being overweight was strongly associated with poor local community development and lower level of urbanization. The overall prevalence of overweight (23.1%, including obesity) and obesity (6.9%) in Serbian primary-school children seem to be comparable to rather high rates previously reported in other countries participating in the COSI program, indicating an obesity epidemic in Serbian children. This surveillance system should be regularly implemented throughout Europe, providing comparable data on rates of overweight/obesity in primary schools that might drive prudent actions to reverse the pandemic trend of childhood obesity.

Fast Entanglement Establishment via Local Dynamics for Quantum Repeater Networks

NASA Astrophysics Data System (ADS)

Gyongyosi, Laszlo; Imre, Sandor

Quantum entanglement is a necessity for future quantum communication networks, quantum internet, and long-distance quantum key distribution. The current approaches of entanglement distribution require high-delay entanglement transmission, entanglement swapping to extend the range of entanglement, high-cost entanglement purification, and long-lived quantum memories. We introduce a fundamental protocol for establishing entanglement in quantum communication networks. The proposed scheme does not require entanglement transmission between the nodes, high-cost entanglement swapping, entanglement purification, or long-lived quantum memories. The protocol reliably establishes a maximally entangled system between the remote nodes via dynamics generated by local Hamiltonians. The method eliminates the main drawbacks of current schemes allowing fast entanglement establishment with a minimized delay. Our solution provides a fundamental method for future long-distance quantum key distribution, quantum repeater networks, quantum internet, and quantum-networking protocols. This work was partially supported by the GOP-1.1.1-11-2012-0092 project sponsored by the EU and European Structural Fund, by the Hungarian Scientific Research Fund - OTKA K-112125, and by the COST Action MP1006.

An ESR protocol based on relaxation phenomena of irradiated Japanese pepper

NASA Astrophysics Data System (ADS)

Ukai, Mitsuko; Nakamura, Hideo; Shimoyama, Yuhei

2006-03-01

We found various free radicals in a commercially available pepper in Japan before and after irradiation using electron spin resonance (ESR) spectroscopy. The typical ESR spectrum of the pepper consists of a sextet centered at g = 2.0, a singlet at the same g-value and a singlet at g = 4.0. Upon gamma ray irradiation, a new pair of signals appeared in the pepper. The progressive saturation behavior (PSB) at various microwave power levels indicated quite different relaxation behaviors of those radicals. Namely, the peak intensity of the organic free radical component decreases in a monotonic fashion, whereas the Mn 2+ and Fe 3+ ESR signals substantially keep constant. This reflects the evidence of three independent radicals in the pepper before irradiation. The PSB of the pair peaks as induced by irradiation possessed quite different PSB from that of the free radical located at g = 2.0. We proposed a new protocol for the ESR detection of irradiated foods by the PSB method at different microwave power levels. This would call for a major modification of the CEN protocol in European Union.

Spot test analysis of microbial contents during composting of kitchen- and garden biowaste: sampling procedures, bacterial reductions, time-temperature relationships, and their relevance for EU-regulations concerning animal by-products.

PubMed

Bijlsma, P B; de Wit, D H; Duindam, J W; Elsinga, G J; Elsinga, W

2013-01-30

This study was aimed to collect data and develop methodologies to determine if and how Dutch biowaste composting plants can meet the microbiological requirements set out in EU-Regulations (EC) 1774/2002 and (EC) 1069/2009, and to provide the European Food and Safety Authority (EFSA) with data and analysis for evaluation of these regulations. We examined twenty plant locations and four types of composting technologies, all with forced aeration and without an anaerobic digestion phase. Raw biowaste, material after sanitation and compost were sampled by spot test analysis according to a standard protocol, and according to an additional protocol with enhanced hygienic precautions. Samples were analyzed for Escherichia coli, Enterococcaceae and Salmonella content. The latter protocol resulted in improved bacterial reductions after sanitation, whereas in compost Enterococcus levels but not E. coli levels increased substantially with both protocols, due to more thermo-resistant regrowth. Salmonella presence in compost coincided with low temperatures and increased levels of E. coli and Enterococcus, absence of Salmonella was associated with absence of E. coli (74%), but not with absence of Enterococcus (17%). In compost, E. coli and Salmonella showed a comparable time-temperature inactivation pattern. A pilot study with co-composting of biowaste and poultry manure indicated a similar inactivation pattern for ESBL-containing bacteria. We conclude that the abundance of Enterococcus in compost is caused by regrowth and not by (re)contamination, and that E. coli is a more reliable indicator species for the absence/presence of Salmonella in compost. Compliance with current EU-regulations concerning biowaste composting can be shown by spot test analysis at all examined plants, provided that adequate hygienic precautions are taken during sampling. Copyright © 2012 Elsevier Ltd. All rights reserved.

Antinociceptive effect of systemically administered dipyrone (metamizol), magnesium chloride or both in a murine model of cancer.

PubMed

Brito, B E; Vazquez, E; Taylor, P; Alvarado, Y; Vanegas, H; Millan, A; Tortorici, V

2017-03-01

Opioid effectiveness to treat cancer pain is often compromised by the development of tolerance and the occurrence of undesirable side effects, particularly during long-term treatment. Hence, the search for more efficient analgesics remains a necessity. The main goal of this study was to relieve neuropathic symptoms associated with tumour growth by administering the non-opioid analgesic dipyrone (DIP) alone or in combination with magnesium chloride (MgCl 2 ), an adjuvant that blocks the NMDA receptor channel. Mice were inoculated with a melanoma cell line (B16-BL6) in the left thigh and two protocols were used to evaluate the effect of DIP (270 mg/kg), MgCl 2 (200 mg/kg), or the combination DIP-MgCl 2 . In the therapeutic protocol the drugs, alone or combined, were administered once tumour had promoted increased nociception. In the preventive protocol, drugs were administered prior to the appearance of the primary tumour. Tumour growth was assessed with a caliper and nociception was determined using behavioural tests. DIP promoted antinociception only at the beginning of both protocols due to the development of tolerance. The combination DIP-MgCl 2 improved the antinociceptive effect, avoiding tolerance and reducing tumour growth in the preventive treatment, more efficiently than each compound alone. These results suggest that DIP-MgCl 2 may represent a safe, affordable and accessible option to reduce tumour growth and to treat cancer pain avoiding the risk of tolerance, without the typical complications of opioids agents, particularly when long-term treatment is required. This study shows a non-opioid analgesic combined with an adjuvant as a therapeutic option to treat cancer pain. The avoidance of antinociceptive tolerance when repeated administration is required, as well as tumor growth reduction, are additional advantages to be considered. © 2016 European Pain Federation - EFIC®.

'Children and obesity: a pan-European project examining the role of food marketing'.

PubMed

Matthews, Anne E

2008-02-01

Rising levels of obesity in school-age children across Europe are causing increasing concern. The 'Children, Obesity and associated avoidable Chronic Diseases' project sought to examine the effects of promotion within food marketing, given the influential role it plays in children's diets. A questionnaire and data-collection protocol was designed for the national co-ordinators, facilitating standardized responses. Co-ordinators collected data from within 20 European Union countries relating to food promotion to children. Results showed that unhealthy foods such as savoury snacks and confectionary were the most commonly marketed and consumed by children across all countries. Television was found to be the prime promotional medium, with in-school and internet marketing seen as growth areas. Media literacy programmes designed specifically to counterbalance the effects of food marketing to children were reported by only a few of the 20 countries. An ineffective and incoherent pattern of regulation was observed across the countries as few governments imposed tough restrictions with most preferring to persuade industry to voluntarily act with responsibly. Most health, consumer and public interest groups supported food marketing restrictions whilst industry and media groups advocated self-regulation. Recommendations include the amendment of the European Union's Television Without Frontiers Directive to ban all TV advertising of unhealthy food to children, the adoption of a commonly agreed European Union definition of an 'unhealthy' food, and the establishment of a mechanism for pan-European monitoring of the nature and extent of food marketing to children and its regulation.

The Clinical Development of Molecularly Targeted Agents in Combination With Radiation Therapy: A Pharmaceutical Perspective

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

Ataman, Ozlem U., E-mail: ouataman@hotmail.com; Sambrook, Sally J.; Wilks, Chris

2012-11-15

Summary: This paper explores historical and current roles of pharmaceutical industry sponsorship of clinical trials testing radiation therapy combinations with molecularly targeted agents and attempts to identify potential solutions to expediting further combination studies. An analysis of clinical trials involving a combination of radiation therapy and novel cancer therapies was performed. Ongoing and completed trials were identified by searching the (clinicaltrials.gov) Web site, in the first instance, with published trials of drugs of interest identified through American Society of Clinical Oncology, European CanCer Organisation/European Society for Medical Oncology, American Society for Radiation Oncology/European Society for Therapeutic Radiology and Oncology, andmore » PubMed databases and then cross-correlated with (clinicaltrials.gov) protocols. We examined combination trials involving radiation therapy with novel agents and determined their distribution by tumor type, predominant molecular mechanisms examined in combination to date, timing of initiation of trials relative to a novel agent's primary development, and source of sponsorship of such trials. A total of 564 studies of targeted agents in combination with radiation therapy were identified with or without concomitant chemotherapy. Most studies were in phase I/II development, with only 36 trials in phase III. The tumor site most frequently studied was head and neck (26%), followed by non-small cell lung cancer. Pharmaceutical companies were the sponsors of 33% of studies overall and provided support for only 16% of phase III studies. In terms of pharmaceutical sponsorship, Genentech was the most active sponsor of radiation therapy combinations (22%), followed by AstraZeneca (14%). Most radiation therapy combination trials do not appear to be initiated until after drug approval. In phase III studies, the most common (58%) primary endpoint was overall survival. Collectively, this analysis suggests that such trials are not given priority by pharmaceutical companies. The potential reasons for this and some challenges and possible solutions are discussed.« less

Comparison between European and Iranian cutoff points of triglyceride/high-density lipoprotein cholesterol concentrations in predicting cardiovascular disease outcomes.

PubMed

Gharipour, Mojgan; Sadeghi, Masoumeh; Dianatkhah, Minoo; Nezafati, Pouya; Talaie, Mohammad; Oveisgharan, Shahram; Golshahi, Jafar

2016-01-01

High triglyceride (TG) and low high-density lipoprotein cholesterol (HDL-C) are important cardiovascular risk factors. The exact prognostic value of the TG/HDL-C ratio, a marker for cardiovascular events, is currently unknown among Iranians so this study sought to determine the optimal cutoff point for the TG/HDL-C ratio in predicting cardiovascular disease events in the Iranian population. The Isfahan Cohort Study (ICS) is an ongoing, longitudinal, population-based study that was originally conducted on adults aged ≥ 35 years, living in urban and rural areas of three districts in central Iran. After 10 years of follow-up, 5431 participants were re-evaluated using a standard protocol similar to the one used for baseline. At both measurements, participants underwent medical interviews, physical examinations, and fasting blood measurements. "High-risk" subjects were defined by the discrimination power of indices, which were assessed using receiver operating characteristic (ROC) analysis; the optimal cutoff point value for each index was then derived. The mean age of the participants was 50.7 ± 11.6 years. The TG/HDL-C ratio, at a threshold of 3.68, was used to screen for cardiovascular events among the study population. Subjects were divided into two groups ("low" and "high" risk) according to the TG/HDL-C concentration ratio at baseline. A slightly higher number of high-risk individuals were identified using the European cutoff points of 63.7% in comparison with the ICS cutoff points of 49.5%. The unadjusted hazard ratio (HR) was greatest in high-risk individuals identified by the ICS cutoff points (HR = 1.54, 95% CI [1.33-1.79]) vs European cutoff points (HR = 1.38, 95% [1.17-1.63]). There were no remarkable changes after adjusting for differences in sex and age (HR = 1.58, 95% CI [1.36-1.84] vs HR = 1.44, 95% CI [1.22-1.71]) for the ICS and European cutoff points, respectively. The threshold of TG/HDL ≥ 3.68 is the optimal cutoff point for predicting cardiovascular events in Iranian individuals. Copyright © 2016 National Lipid Association. Published by Elsevier Inc. All rights reserved.

Cleft Lip and Palate: An Experience of a Developing Center in Egypt.

PubMed

Abulezz, Tarek A

2017-11-01

Cleft lip and palate is the most common congenital anomaly in the head and neck region. These clefts are not just a distortion of the normal appearance, but they may impose a major influence on the whole patient's life, both functionally and psychologically. Clefts affect feeding, teething, hearing, speech, and social communication. The incidence of cleft lip and palate is variable in different countries and different communities. The surgical correction of cleft lip and palate went through many evolutions, but still there is no single universal protocol of repair; however, many European countries have adopted national protocols and have established cleft centers for the management and follow up of affected population. In this study, the problem of cleft lip and palate in the area of upper Egypt was presented through the records of patients admitted to the Department of Plastic Surgery at the Sohag University Hospital in a 15-year period (2001-2015). A total number of 1318 patients, who were admitted and had been operated upon in our department, were included in this study. The majority of patients presented to the department with a primary disease, yet 14.7% (194 patients) of them were first presented for a secondary interference after being operated upon elsewhere. A total number of 1923 surgical procedures were performed.

Effect of different disinfection protocols on microbial and biofilm contamination of dental unit waterlines in community dental practices.

PubMed

Dallolio, Laura; Scuderi, Amalia; Rini, Maria S; Valente, Sabrina; Farruggia, Patrizia; Sabattini, Maria A Bucci; Pasquinelli, Gianandrea; Acacci, Anna; Roncarati, Greta; Leoni, Erica

2014-02-18

Output water from dental unit waterlines (DUWLs) may be a potential source of infection for both dental healthcare staff and patients. This study compared the efficacy of different disinfection methods with regard to the water quality and the presence of biofilm in DUWLs. Five dental units operating in a public dental health care setting were selected. The control dental unit had no disinfection system; two were disinfected intermittently with peracetic acid/hydrogen peroxide 0.26% and two underwent continuous disinfection with hydrogen peroxide/silver ions (0.02%) and stabilized chlorine dioxide (0.22%), respectively. After three months of applying the disinfection protocols, continuous disinfection systems were more effective than intermittent systems in reducing the microbial contamination of the water, allowing compliance with the CDC guidelines and the European Council regulatory thresholds for drinking water. P. aeruginosa, Legionella spp, sulphite-reducing Clostridium spores, S. aureus and β-haemolytic streptococci were also absent from units treated with continuous disinfection. The biofilm covering the DUWLs was more extensive, thicker and more friable in the intermittent disinfection dental units than in those with continuous disinfection. Overall, the findings showed that the products used for continuous disinfection of dental unit waterlines showed statistically better results than the intermittent treatment products under the study conditions.

Effect of Different Disinfection Protocols on Microbial and Biofilm Contamination of Dental Unit Waterlines in Community Dental Practices

PubMed Central

Dallolio, Laura; Scuderi, Amalia; Rini, Maria S.; Valente, Sabrina; Farruggia, Patrizia; Bucci Sabattini, Maria A.; Pasquinelli, Gianandrea; Acacci, Anna; Roncarati, Greta; Leoni, Erica

2014-01-01

Output water from dental unit waterlines (DUWLs) may be a potential source of infection for both dental healthcare staff and patients. This study compared the efficacy of different disinfection methods with regard to the water quality and the presence of biofilm in DUWLs. Five dental units operating in a public dental health care setting were selected. The control dental unit had no disinfection system; two were disinfected intermittently with peracetic acid/hydrogen peroxide 0.26% and two underwent continuous disinfection with hydrogen peroxide/silver ions (0.02%) and stabilized chlorine dioxide (0.22%), respectively. After three months of applying the disinfection protocols, continuous disinfection systems were more effective than intermittent systems in reducing the microbial contamination of the water, allowing compliance with the CDC guidelines and the European Council regulatory thresholds for drinking water. P. aeruginosa, Legionella spp, sulphite-reducing Clostridium spores, S. aureus and β-haemolytic streptococci were also absent from units treated with continuous disinfection. The biofilm covering the DUWLs was more extensive, thicker and more friable in the intermittent disinfection dental units than in those with continuous disinfection. Overall, the findings showed that the products used for continuous disinfection of dental unit waterlines showed statistically better results than the intermittent treatment products under the study conditions. PMID:24552789

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30: factorial models to Brazilian cancer patients

PubMed Central

Campos, Juliana Alvares Duarte Bonini; Spexoto, Maria Cláudia Bernardes; da Silva, Wanderson Roberto; Serrano, Sergio Vicente; Marôco, João

2018-01-01

ABSTRACT Objective To evaluate the psychometric properties of the seven theoretical models proposed in the literature for European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), when applied to a sample of Brazilian cancer patients. Methods Content and construct validity (factorial, convergent, discriminant) were estimated. Confirmatory factor analysis was performed. Convergent validity was analyzed using the average variance extracted. Discriminant validity was analyzed using correlational analysis. Internal consistency and composite reliability were used to assess the reliability of instrument. Results A total of 1,020 cancer patients participated. The mean age was 53.3±13.0 years, and 62% were female. All models showed adequate factorial validity for the study sample. Convergent and discriminant validities and the reliability were compromised in all of the models for all of the single items referring to symptoms, as well as for the “physical function” and “cognitive function” factors. Conclusion All theoretical models assessed in this study presented adequate factorial validity when applied to Brazilian cancer patients. The choice of the best model for use in research and/or clinical protocols should be centered on the purpose and underlying theory of each model. PMID:29694609

An empirical investigation of acculturative stress and ethnic identity as moderators for depression and suicidal ideation in college students.

PubMed

Walker, Rheeda L; Wingate, Laricka R; Obasi, Ezemenari M; Joiner, Thomas E

2008-01-01

The purpose of this study was to explore the relationships of acculturative stress and ethnic identity to depressive symptomatology and suicidal ideation in college students. The SAFE Acculturative Stress Scale, Multi-Group Ethnic Identity Measure, Beck Depression Inventory, and Beck Suicide Scale were administered to 452 college students. The authors found that acculturative stress and ethnic identity moderated the depression-suicide ideation relationship for African American but not European American college students. Given that vulnerability toward suicidal thoughts is increased for African American college students who report symptoms of depression accompanied by either high-acculturative stress or poor group identity, these culturally relevant factors should be included in protocol for suicide risk assessment.

Tidbits for the synthesis of bis(2-sulfanylethyl)amido (SEA) polystyrene resin, SEA peptides and peptide thioesters.

PubMed

Ollivier, Nathalie; Raibaut, Laurent; Blanpain, Annick; Desmet, Rémi; Dheur, Julien; Mhidia, Reda; Boll, Emmanuelle; Drobecq, Hervé; Pira, Silvain L; Melnyk, Oleg

2014-02-01

Protein total chemical synthesis enables the atom-by-atom control of the protein structure and therefore has a great potential for studying protein function. Native chemical ligation of C-terminal peptide thioesters with N-terminal cysteinyl peptides and related methodologies are central to the field of protein total synthesis. Consequently, methods enabling the facile synthesis of peptide thioesters using Fmoc-SPPS are of great value. Herein, we provide a detailed protocol for the preparation of bis(2-sulfanylethyl)amino polystyrene resin as a starting point for the synthesis of C-terminal bis(2-sulfanylethyl)amido peptides and of peptide thioesters derived from 3-mercaptopropionic acid. Copyright © 2013 European Peptide Society and John Wiley & Sons, Ltd.

Clinical efficacy of β-lactam/β-lactamase inhibitor combinations for the treatment of bloodstream infection due to extended-spectrum β-lactamase-producing Enterobacteriaceae in haematological patients with neutropaenia: a study protocol for a retrospective observational study (BICAR).

PubMed

Gudiol, C; Royo-Cebrecos, C; Tebe, C; Abdala, E; Akova, M; Álvarez, R; Maestro-de la Calle, G; Cano, A; Cervera, C; Clemente, W T; Martín-Dávila, P; Freifeld, A; Gómez, L; Gottlieb, T; Gurguí, M; Herrera, F; Manzur, A; Maschmeyer, G; Meije, Y; Montejo, M; Peghin, M; Rodríguez-Baño, J; Ruiz-Camps, I; Sukiennik, T C; Carratalà, J

2017-01-23

Bloodstream infection (BSI) due to extended-spectrum β-lactamase-producing Gram-negative bacilli (ESBL-GNB) is increasing at an alarming pace worldwide. Although β-lactam/β-lactamase inhibitor (BLBLI) combinations have been suggested as an alternative to carbapenems for the treatment of BSI due to these resistant organisms in the general population, their usefulness for the treatment of BSI due to ESBL-GNB in haematological patients with neutropaenia is yet to be elucidated. The aim of the BICAR study is to compare the efficacy of BLBLI combinations with that of carbapenems for the treatment of BSI due to an ESBL-GNB in this population. A multinational, multicentre, observational retrospective study. Episodes of BSI due to ESBL-GNB occurring in haematological patients and haematopoietic stem cell transplant recipients with neutropaenia from 1 January 2006 to 31 March 2015 will be analysed. The primary end point will be case-fatality rate within 30 days of onset of BSI. The secondary end points will be 7-day and 14-day case-fatality rates, microbiological failure, colonisation/infection by resistant bacteria, superinfection, intensive care unit admission and development of adverse events. The number of expected episodes of BSI due to ESBL-GNB in the participant centres will be 260 with a ratio of control to experimental participants of 2. The protocol of the study was approved at the first site by the Research Ethics Committee (REC) of Hospital Universitari de Bellvitge. Approval will be also sought from all relevant RECs. Any formal presentation or publication of data from this study will be considered as a joint publication by the participating investigators and will follow the recommendations of the International Committee of Medical Journal Editors (ICMJE). The study has been endorsed by the European Study Group for Bloodstream Infection and Sepsis (ESGBIS) and the European Study Group for Infections in Compromised Hosts (ESGICH). Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Age but not Philadelphia positivity impairs outcome in older/elderly patients with acute lymphoblastic leukemia in Sweden.

PubMed

Kozlowski, Piotr; Lennmyr, Emma; Ahlberg, Lucia; Bernell, Per; Hulegårdh, Erik; Karbach, Holger; Karlsson, Karin; Tomaszewska-Toporska, Beata; Åström, Maria; Hallböök, Heléne

2017-08-01

Older/elderly patients with acute lymphoblastic leukemia (ALL) are poorly represented in clinical trials. Using Swedish national leukemia registries, we investigated disease/patient characteristics, treatment choices, outcome, and the impact of an age-adapted protocol (introduced in 2009) in this population-based study of patients aged 55-85 years, diagnosed with ALL 2005-2012. Of 174 patients, 82% had B-phenotype, 11% Burkitt leukemia (excluded), and 7% T-phenotype. Philadelphia chromosome positivity (Ph+) occurred in 35%. Of the 155 B- and T-ALL patients, 80% were treated with intensive protocols, and 20% with a palliative approach. Higher age and WHO performance status ≥2 influenced the choice of palliation. Intensive, palliative, and both approaches resulted in complete remission rate 83/16/70% and 3-year overall survival (OS) 32/3/26%. The age-adapted protocol did not improve outcome. With intensive treatment, platelet count ≤35×10 9 /L and age ≥75 years were adverse prognostic factors for OS, Ph+ was not. Male sex was an adverse prognostic factor in the 55-64 year age-group. We report a high frequency of Ph+ in older/elderly patients, with no evidence of poorer outcome compared to Ph-negative disease. Overall prognosis for elderly patients with ALL remains dismal, despite the use of age-adapted treatment. © 2017 The Authors. European Journal of Haematology Published by John Wiley & Sons Ltd.

Cleaning, Disinfection, and Sterilization Protocols Employed for Customized Implant Abutments: An International Survey of 100 Universities Worldwide.

PubMed

Canullo, Luigi; Tallarico, Marco; Chu, Stephen; Peñarrocha, David; Özcan, Mutlu; Pesce, Paolo

American and European standards recommend sterilization of customized abutments before connecting them to implants, as customized abutments are considered semi-critical medical devices. Since standardized procedures could not be identified in the literature on implantology, this survey evaluated the protocols employed at different universities worldwide to clean, disinfect, and/or sterilize customized abutments before their connection to bone-level implants. The survey took place between October 2015 and January 2016. A single question acquiring information on how customized abutments were treated prior to connection to the implants was sent by email to researchers affiliated at 100 universities worldwide. To avoid any bias, the survey was kept rigorously anonymous. A total of 100 universities from Europe (56), USA and Canada (25), Latin America (9), South Africa (1), Asia (6), and Australia and New Zealand (3) were invited to participate in the survey. Altogether, 85 universities responded to the survey question, and 22 (25.9%) declared that no cleaning protocols were adopted. More than half of the respondents (n = 49, 57.6%) performed only one of the three procedures required by the standards (cleaning, disinfection, or sterilization). Twelve respondents (14.1%) adopted two procedures, and only two universities performed all three required procedures (2.4%). This survey indicated substantial heterogeneity in treating customized abutments before connecting them to implants. This study demonstrated that the majority of the universities applied either cleaning, disinfection, or sterilization which may not meet the prevailing standards.

The impact of Last Glacial climate variability in west-European loess revealed by radiocarbon dating of fossil earthworm granules.

PubMed

Moine, Olivier; Antoine, Pierre; Hatté, Christine; Landais, Amaëlle; Mathieu, Jérôme; Prud'homme, Charlotte; Rousseau, Denis-Didier

2017-06-13

The characterization of Last Glacial millennial-timescale warming phases, known as interstadials or Dansgaard-Oeschger events, requires precise chronologies for the study of paleoclimate records. On the European continent, such chronologies are only available for several Last Glacial pollen and rare speleothem archives principally located in the Mediterranean domain. Farther north, in continental lowlands, numerous high-resolution records of loess and paleosols sequences show a consistent environmental response to stadial-interstadial cycles. However, the limited precision and accuracy of luminescence dating methods commonly used in loess deposits preclude exact correlations of paleosol horizons with Greenland interstadials. To overcome this problem, a radiocarbon dating protocol has been developed to date earthworm calcite granules from the reference loess sequence of Nussloch (Germany). Its application yields a consistent radiocarbon chronology of all soil horizons formed between 47 and 20 ka and unambiguously shows the correlation of every Greenland interstadial identified in isotope records with specific soil horizons. Furthermore, eight additional minor soil horizons dated between 27.5 and 21 ka only correlate with minor decreases in Greenland dust records. This dating strategy reveals the high sensitivity of loess paleoenvironments to Northern Hemisphere climate changes. A connection between loess sedimentation rate, Fennoscandian ice sheet dynamics, and sea level changes is proposed. The chronological improvements enabled by the radiocarbon "earthworm clock" thus strongly enhance our understanding of loess records to a better perception of the impact of Last Glacial climate changes on European paleoenvironments.

Experiences with the European guidelines on quality criteria for radiographic images in Tanzania

PubMed Central

Muhogora, W. E.; Nyanda, A. M.; Kazema, R. R.

2001-01-01

Objective assessment of the quality of radiographic images is practically a difficult task and protocols that address this problem are few. In 1996, the European union published nearly objective image quality criteria to unify the practices in Europe. However, experience with these criteria in countries of lower health care levels is little documented. As a case study in Tanzania, we present the general performance of European guidelines in some Tanzanian hospitals to a total of 200 radiographs obtained from some common x‐ray examinations. The results show that more than 70% of chest (PA), lumbar spine (AP), and pelvis AP radiographs passed the quality criteria, while the performance of lumbar spine LAT x‐ray examinations was about 50% and therefore less satisfactory. The corresponding mean entrance dose to the patient for specified x‐ray techniques was of range 0.08–0.56 mGy, 3.1–7.7 mGy, 2.53–5.4 mGy, and 4.0–16.78 mGy for chest PA, lumbar spine AP, pelvis AP and lumbar spine LAT x‐ray examinations, respectively. Although a good number of observers were not well familiar to the guidelines, the quality criteria have been found useful and their adoption in the country recommended. The need to provide relevant education and training to staff in the radiology departments is of utmost importance. PACS number(s): 87.57.–s, 87.52.–g PMID:11686743

Variations in the sales and sales patterns of veterinary antimicrobial agents in 25 European countries.

PubMed

Grave, Kari; Torren-Edo, Jordi; Muller, Arno; Greko, Christina; Moulin, Gerard; Mackay, David

2014-08-01

To describe sales and sales patterns of veterinary antimicrobial agents in 25 European Union (EU)/European Economic Area (EEA) countries for 2011. Data on the sales of veterinary antimicrobial agents from 25 EU member states and EEA countries for 2011 were collected at package level (name, formulation, strength, pack size, number of packages sold) according to a standardized protocol and template and presented in a harmonized manner. These data were calculated to express amounts sold, in metric tonnes, of active ingredient of each package. A population correction unit (PCU) was applied as a proxy for the animal biomass potentially treated with antimicrobial agents. The indicator used to express sales was milligrams of active substance per PCU. Substantial variations in the sales patterns and in the magnitude of sales of veterinary antimicrobial agents, expressed as mg/PCU, between the countries were observed. The proportion of sales, in mg/PCU, of products applicable for treatment of groups or herds of animals (premixes, oral powders and oral solution) varied considerably between the countries. Some countries reported much lower sales of veterinary antimicrobial agents than others, when expressed as mg/PCU. Sales patterns varied between countries, particularly with respect to pharmaceutical forms. Further studies are needed to understand the factors that explain the observed differences. © The Author 2014. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

The impact of Last Glacial climate variability in west-European loess revealed by radiocarbon dating of fossil earthworm granules

PubMed Central

Moine, Olivier; Antoine, Pierre; Hatté, Christine; Landais, Amaëlle; Mathieu, Jérôme; Prud’homme, Charlotte

2017-01-01

The characterization of Last Glacial millennial-timescale warming phases, known as interstadials or Dansgaard–Oeschger events, requires precise chronologies for the study of paleoclimate records. On the European continent, such chronologies are only available for several Last Glacial pollen and rare speleothem archives principally located in the Mediterranean domain. Farther north, in continental lowlands, numerous high-resolution records of loess and paleosols sequences show a consistent environmental response to stadial–interstadial cycles. However, the limited precision and accuracy of luminescence dating methods commonly used in loess deposits preclude exact correlations of paleosol horizons with Greenland interstadials. To overcome this problem, a radiocarbon dating protocol has been developed to date earthworm calcite granules from the reference loess sequence of Nussloch (Germany). Its application yields a consistent radiocarbon chronology of all soil horizons formed between 47 and 20 ka and unambiguously shows the correlation of every Greenland interstadial identified in isotope records with specific soil horizons. Furthermore, eight additional minor soil horizons dated between 27.5 and 21 ka only correlate with minor decreases in Greenland dust records. This dating strategy reveals the high sensitivity of loess paleoenvironments to Northern Hemisphere climate changes. A connection between loess sedimentation rate, Fennoscandian ice sheet dynamics, and sea level changes is proposed. The chronological improvements enabled by the radiocarbon “earthworm clock” thus strongly enhance our understanding of loess records to a better perception of the impact of Last Glacial climate changes on European paleoenvironments. PMID:28559353

Study protocol of physical activity and sedentary behaviour measurement among schoolchildren by accelerometry--cross-sectional survey as part of the ENERGY-project.

PubMed

Yıldırım, Mine; Verloigne, Maïté; de Bourdeaudhuij, Ilse; Androutsos, Odysseas; Manios, Yannis; Felso, Regina; Kovács, Éva; Doessegger, Alain; Bringolf-Isler, Bettina; te Velde, Saskia J; Brug, Johannes; Chinapaw, Mai J M

2011-03-25

Physical activity and sedentary behaviour among children should be measured accurately in order to investigate their relationship with health. Accelerometry provides objective and accurate measurement of body movement, which can be converted to meaningful behavioural outcomes. The aim of this study was to evaluate the best evidence for the decisions on data collection and data processing with accelerometers among children resulting in a standardized protocol for use in the participating countries. This cross-sectional accelerometer study was conducted as part of the European ENERGY-project that aimed to produce an obesity prevention intervention among schoolchildren. Five countries, namely Belgium, Greece, Hungary, Switzerland and the Netherlands participated in the accelerometer study. We used three different Actigraph models--Actitrainers (triaxial), GT3Xs and GT1Ms. Children wore the device for six consecutive days including two weekend days. We selected an epoch length of 15 seconds. Accelerometers were placed at children's waist at the right side of the body in an elastic belt. In total, 1082 children participated in the study (mean age = 11.7 ± 0.75 y, 51% girls). Non-wearing time was calculated as periods of more than 20 minutes of consecutive zero counts. The minimum daily wearing time was set to 10 hours for weekdays and 8 hours for weekend days. The inclusion criterion for further analysis was having at least three valid weekdays and one valid weekend day. We selected a cut-point (count per minute (cpm)) of <100 cpm for sedentary behaviour, <3000 cpm for light, <5200 cpm for moderate, and >5200 cpm for vigorous physical activity. We also created time filters for school-time during data cleaning in order to explore school-time physical activity and sedentary behaviour patterns in particular. This paper describes the decisions for data collection and processing. Use of standardized protocols would ease future use of accelerometry and the comparability of results between studies.

Developmental Therapeutics Consortium report on study design effects on trial outcomes in chronic myeloid leukaemia.

PubMed

Giles, Francis; Mahon, François-Xavier; Gjertsen, Bjorn; Swords, Ronan; Labar, Boris; Turkina, Anna; Rosti, Gianantonio

2012-09-01

Tyrosine kinase inhibitors (TKIs) have dramatically changed the treatment of chronic myeloid leukaemia (CML). Results from ongoing phase 3 trials with nilotinib [Efficacy and Safety in Clinical Trials-Newly Diagnosed Patients (ENESTnd)] and dasatinib [Dasatinib Versus Imatinib Study in Treatment-Naive CML-CP Patients (DASISION)] in newly diagnosed patients with CML in chronic phase have demonstrated that these TKIs resulted in significant improvements in responses vs. imatinib. The Developmental Therapeutics Consortium (DTC) systematically reviewed the published literature to provide a comparative analysis of the ENESTnd and DASISION trial designs and data reported on each study. The recent approval of nilotinib and dasatinib based on these two pivotal studies offers physicians the option to optimise frontline treatment based on a patient's comorbidities, risk factors and tolerability profiles. Although nilotinib and dasatinib provide effective therapeutic options for the frontline treatment of CML, the lack of an evidenced-based, side-by-side comparison makes it difficult to directly compare these agents. Despite potential bias from differences in patient populations and study design, indirect cross-trial comparisons to determine the relative effectiveness of these agents will be performed by physicians. This DTC report provides a comprehensive summary of the study designs, protocols and results of the ENESTnd and DASISION trials, which will assist physicians in making informed decisions on the best treatment approach for their patients. © 2012 The Authors. European Journal of Clinical Investigation © 2012 Stichting European Society for Clinical Investigation Journal Foundation.

Study protocol: evaluation of specialized outpatient palliative care (SOPC) in the German state of Hesse (ELSAH study) - work package II: palliative care for pediatric patients.

PubMed

Ulrich, Lisa-R; Gruber, Dania; Hach, Michaela; Boesner, Stefan; Haasenritter, Joerg; Kuss, Katrin; Seipp, Hannah; Gerlach, Ferdinand M; Erler, Antje

2018-01-05

In 2007, the European Association of Palliative Care (EAPC) provided a comprehensive set of recommendations and standards for the provision of adequate pediatric palliative care. A number of studies have shown deficits in pediatric palliative care compared to EAPC standards. In Germany, pediatric palliative care patients can be referred to specialized outpatient palliative care (SOPC) services, which are known to enhance quality of life, e.g. by avoiding hospitalization. However, current regulations for the provision of SOPC in Germany do not account for the different circumstances and needs of children and their families compared to adult palliative care patients. The "Evaluation of specialized outpatient palliative care (SOPC) in the German state of Hesse (ELSAH)" study aims to perform a needs assessment for pediatric patients (children, adolescents and young adults) receiving SOPC. This paper presents the study protocol for this assessment (work package II). The study uses a sequential mixed-methods study design with a focus on qualitative research. Data collection from professional and family caregivers and, as far as possible, pediatric patients, will involve both a written questionnaire based on European recommendations for pediatric palliative care, and semi-structured interviews. Additionally, professional caregivers will take part in focus group discussions and participatory observations. Interviews and focus groups will be tape- or video-recorded, transcribed verbatim and analyzed in accordance with the principles of grounded theory (interviews) and content analysis (focus groups). A structured field note template will be used to record notes taken during the participatory observations. Statistical Package for Social Sciences (SPSS, version 22 or higher) will be used for descriptive statistical analyses. The qualitative data analyses will be software-assisted by MAXQDA (version 12 or higher). This study will provide important information on what matters most to family caregivers and pediatric patients receiving SOPC. The results will add valuable knowledge to the criteria that distinguish SOPC for pediatric from SOPC for adult patients, and will provide an indication of how the German SOPC rule of procedure can be optimized to satisfy the special needs of pediatric patients. Internet Portal of the German Clinical Trials Register ( www.germanctr.de , DRKS-ID: DRKS00012431).

Respiratory research networks in Europe and beyond: aims, achievements and aspirations for the 21st century

PubMed Central

Zampieri, Fernando; Povoa, Pedro; Ranzani, Otavio; Bos, Lieuwe D.; Aliberti, Stefano; Torres, Antoni

2017-01-01

Healthcare-associated infection, such as intensive care unit (ICU)-related respiratory infections, remain the most frequently encountered morbidity of ICU admission, prolonging hospital stay and increasing mortality rates. The epidemiology of ICU-related respiratory infections, particularly nonventilated ICU-associated pneumonia and ventilator-associated tracheobronchitis, appears to be quite different among different countries. European countries have different prevalence, patterns and mechanism of resistance, as well as different treatments chosen by different attending physicians. The classical clinical research process in respiratory infections consists of the following loop: 1) identification of knowledge gaps; 2) systematic review and search for adequate answers; 3) generation of study hypotheses; 4) design of study protocols; 5) collection clinical data; 6) analysis and interpretation of the results; and 7) implementation of the results in clinical practice. PMID:28894481

Light-induced retinal damage using different light sources, protocols and rat strains reveals LED phototoxicity.

PubMed

Krigel, A; Berdugo, M; Picard, E; Levy-Boukris, R; Jaadane, I; Jonet, L; Dernigoghossian, M; Andrieu-Soler, C; Torriglia, A; Behar-Cohen, F

2016-12-17

To save energy, the European directives from the Eco-design of Energy Using Products (2005/32/CE) have recommended the replacement of incandescent lamps by more economic devices such as Light Emitting Diodes (LEDs). However, the emission spectrum of these devices is enriched in blue radiations, known to be potentially dangerous to the retina. Recent studies showed that light exposure contributes to the onset of early stages of age-related macular degeneration (AMD). Here, we investigate, in albinos and pigmented rats, the effects of different exposure protocols. Twenty-four hours exposure at high luminance was compared to a cyclic (dark/light) exposure at domestic levels for 1week and 1month, using different LEDs (Cold-white, blue and green), as well as fluorocompact bulbs and fluorescent tubes. The data suggest that the blue component of the white-LED may cause retinal toxicity at occupational domestic illuminance and not only in extreme experimental conditions, as previously reported. It is important to note that the current regulations and standards have been established on the basis of acute light exposure and do not take into account the effects of repeated exposure. Copyright © 2016 IBRO. Published by Elsevier Ltd. All rights reserved.

Color-dependent learning in restrained Africanized honey bees.

PubMed

Jernigan, C M; Roubik, D W; Wcislo, W T; Riveros, A J

2014-02-01

Associative color learning has been demonstrated to be very poor using restrained European honey bees unless the antennae are amputated. Consequently, our understanding of proximate mechanisms in visual information processing is handicapped. Here we test learning performance of Africanized honey bees under restrained conditions with visual and olfactory stimulation using the proboscis extension response (PER) protocol. Restrained individuals were trained to learn an association between a color stimulus and a sugar-water reward. We evaluated performance for 'absolute' learning (learned association between a stimulus and a reward) and 'discriminant' learning (discrimination between two stimuli). Restrained Africanized honey bees (AHBs) readily learned the association of color stimulus for both blue and green LED stimuli in absolute and discriminatory learning tasks within seven presentations, but not with violet as the rewarded color. Additionally, 24-h memory improved considerably during the discrimination task, compared with absolute association (15-55%). We found that antennal amputation was unnecessary and reduced performance in AHBs. Thus color learning can now be studied using the PER protocol with intact AHBs. This finding opens the way towards investigating visual and multimodal learning with application of neural techniques commonly used in restrained honey bees.

Closing the gap on Achilles tendon rupture: A cadaveric study quantifying the tendon apposition achieved with commonly used immobilisation practices.

PubMed

Collins, Ruaraidh; Sudlow, Alexis; Loizou, Constantinos; Loveday, David T; Smith, George

2018-04-01

The relative benefits of surgical and conservative treatment of Achilles tendon rupture are widely debated. With modern conservative management protocols, the re-rupture risk appears to fall to one similar to surgical repair with negligible loss of function. Conservative management typically employs a period of time in an equinus cast with sequential ankle dorsiflexion in a functional orthosis. The optimal duration of immobilisation and rate of dorsiflexion is unknown. We aimed to quantify the change in Achilles tendon approximation achieved in common immobilisation techniques to assist the design of rehabilitation protocols. Twelve fresh-frozen cadaveric specimens had 2.5cm of Achilles tendon excised. The gap between the tendon ends were measured via windowed full equinus casts and compared with functional boots with successively removed heel wedges. The greatest tendon apposition was achieved with the equinus cast. Each wedge removed decreased the reapproximation by approximately 5mm. This paper supports the early use of maximal equinus casting in early management of acute Achilles tendon ruptures. Copyright © 2017 European Foot and Ankle Society. Published by Elsevier Ltd. All rights reserved.

[France, an attractive country for international clinical research: 2010 survey assessed by Leem (French association of pharmaceutical companies)].

PubMed

Lassale, Catherine; Sibenaler, Claire; Behier, Jehan-Michel; Pletan, Yannick; Courcier, Soizic

2011-01-01

In order to evaluate the attractiveness of France for conducting international clinical trials, a survey is performed every two years among pharmaceutical companies that are based in France or have affiliates in France. Twenty-nine companies (72% of the French market) including 10 newly participants, have participated in the current survey which included 328 international phase II and III clinical studies, 79 countries, 24,337 centres and 249,704 patients (included in 2008/2009). France (291 patients/million inhabitants) ranked among the best European recruiters in second position behind Scandinavia. Since 2008, protocols are still to be given the go-ahead by French Authorities (Afssaps and CPP) within 60 days, in accordance with European directive. The continuation of reduction in deadlines for hospital contracts is encouraging and highlights the positive effect of CeNGEPS. French state-of-art is well recognized in Oncology/Hematology and Orphan disease which could be an example to improve the competitiveness of France in other key therapeutic areas such as Alzheimer's disease and Immuno-Inflammation. © 2011 Société Française de Pharmacologie et de Thérapeutique.

Assessing recovery from acidification of European surface waters in the year 2010: evaluation of projections made with the MAGIC model in 1995.

PubMed

Helliwell, Rachel C; Wright, Richard F; Jackson-Blake, Leah A; Ferrier, Robert C; Aherne, Julian; Cosby, Bernard J; Evans, Christopher D; Forsius, Martin; Hruska, Jakub; Jenkins, Alan; Kram, Pavel; Kopáček, Jiri; Majer, Vladimir; Moldan, Filip; Posch, Maximilian; Potts, Jacqueline M; Rogora, Michela; Schöpp, Wolfgang

2014-11-18

In 1999 we used the MAGIC (Model of Acidification of Groundwater In Catchments) model to project acidification of acid-sensitive European surface waters in the year 2010, given implementation of the Gothenburg Protocol to the Convention on Long-Range Transboundary Air Pollution (LRTAP). A total of 202 sites in 10 regions in Europe were studied. These forecasts can now be compared with measurements for the year 2010, to give a "ground truth" evaluation of the model. The prerequisite for this test is that the actual sulfur and nitrogen deposition decreased from 1995 to 2010 by the same amount as that used to drive the model forecasts; this was largely the case for sulfur, but less so for nitrogen, and the simulated surface water [NO3(-)] reflected this difference. For most of the sites, predicted surface water recovery from acidification for the year 2010 is very close to the actual recovery observed from measured data, as recovery is predominantly driven by reductions in sulfur deposition. Overall these results show that MAGIC successfully predicts future water chemistry given known changes in acid deposition.

Development and characterization of 79 nuclear markers amplifying in viviparous and oviparous clades of the European common lizard.

PubMed

Horreo, J L; Peláez, M L; Suárez, T; Fitze, P S

2018-02-01

The European common lizard (Zootoca vivipara) is a widely distributed species across Europe and Asia exhibiting two reproductive modes (oviparity/viviparity), six major lineages and several sublineages. It has been used to tackle a large variety of research questions, nevertheless, few nuclear DNA sequence markers have been developed for this species. Here we developed 79 new nuclear DNA sequence markers using a clonation protocol. These markers were amplified in several oviparous and viviparous specimens including samples of all extant clades, to test the amplification success and their diversity. 49.4% of the markers were polymorphic and of those, 51.3% amplified in all and 94.9% amplified in 5-7 of the extant Z. vivipara clades. These new markers will be very useful for the study of the population structure, population dynamics, and micro/macro evolution of Z. vivipara. Cross-species amplification in four lizard species (Psammodromus edwardsianus, Podarcis muralis, Lacerta bilineata, and Takydromus sexlineatus) was positive in several of the markers, and six makers amplified in all five species. The large genetic distance between P. edwardsianus and Z. vivipara further suggests that these markers may as well be employed in many other species.

Evaluating multicenter DTI data in Huntington's disease on site specific effects: An ex post facto approach☆

PubMed Central

Müller, Hans-Peter; Grön, Georg; Sprengelmeyer, Reiner; Kassubek, Jan; Ludolph, Albert C.; Hobbs, Nicola; Cole, James; Roos, Raymund A.C.; Duerr, Alexandra; Tabrizi, Sarah J.; Landwehrmeyer, G. Bernhard; Süssmuth, Sigurd D.

2013-01-01

Purpose Assessment of the feasibility to average diffusion tensor imaging (DTI) metrics of MRI data acquired in the course of a multicenter study. Materials and methods Sixty-one early stage Huntington's disease patients and forty healthy controls were studied using four different MR scanners at four European sites with acquisition protocols as close as possible to a given standard protocol. The potential and feasibility of averaging data acquired at different sites was evaluated quantitatively by region-of-interest (ROI) based statistical comparisons of coefficients of variation (CV) across centers, as well as by testing for significant group-by-center differences on averaged fractional anisotropy (FA) values between patients and controls. In addition, a whole-brain based statistical between-group comparison was performed using FA maps. Results The ex post facto statistical evaluation of CV and FA-values in a priori defined ROIs showed no differences between sites above chance indicating that data were not systematically biased by center specific factors. Conclusion Averaging FA-maps from DTI data acquired at different study sites and different MR scanner types does not appear to be systematically biased. A suitable recipe for testing on the possibility to pool multicenter DTI data is provided to permit averaging of DTI-derived metrics to differentiate patients from healthy controls at a larger scale. PMID:24179771

Tinnitus in patients with temporo-mandibular joint disorder: Proposal for a new treatment protocol.

PubMed

Attanasio, Giuseppe; Leonardi, Alessandra; Arangio, Paolo; Minni, Antonio; Covelli, Edoardo; Pucci, Resi; Russo, Francesca Yoshie; De Seta, Elio; Di Paolo, Carlo; Cascone, Piero

2015-06-01

The present study was designed to verify the correlation between tinnitus and temporomandibular joint dysfunction.86 consecutive patients were enrolled in the study, all affected by subjective tinnitus without hearing impairment, from both genders, age between 18 and 60 years old. The final number of patients included in the study was 55. All patients received a temporo-mandibular joint examination. All the patients were asked to rate the severity of their symptoms before and after treatment using a VAS scale and the Tinnitus Handicap Inventory (THI) and they followed a standardized protocol for the investigation of tinnitus. All the subjects were monitored by the same researcher and they underwent the same splint treatment. The comparison between pre- and posttreatment phase scores showed in patients with predisposition of TMD and with TMD a statistically significant decrease of THI and VAS values. The characteristics of tinnitus and the degree of response to treatment confirmed the relationship between tinnitus and TMD. The authors believe that, when the most common causes of tinnitus, such as otologic disorders and neurological diseases are excluded, it is correct to evaluate the functionality of the temporo-mandibular joint and eventually treat its pathology to obtain tinnitus improvement or even resolution. Copyright © 2015 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

The impact of glucocorticosteroids administered for systemic diseases on the osseointegration and survival of dental implants placed without bone grafting-A retrospective study in 31 patients.

PubMed

Petsinis, Vassilis; Kamperos, Georgios; Alexandridi, Foteini; Alexandridis, Konstantinos

2017-08-01

To evaluate the impact of glucocorticosteroids, administered for the treatment of systemic diseases, on the osseointegration and survival of dental implants placed without bone grafting. A retrospective study was conducted in search of patients treated with dental implants while receiving glucocorticosteroid therapy for various systemic diseases. In these cases, a conventional two-stage surgical protocol was used, without bone regeneration procedures. The osseointegration was clinically and radiographically tested at the uncovering of the implants. The follow-up after loading was set at a minimum of 3 years. A total of 31 patients were included in the study. Of the 105 dental implants placed, 104 were osseointegrated (99%). No bone absorption was radiographically noted at the uncovering of the osseointegrated implants. All of the osseointegrated implants were successfully loaded for the prosthetic restoration. The mean follow-up period after loading was 71 months, with an implant survival rate of 99%. Glucocorticosteroid intake for systemic diseases does not have a significant impact on the osseointegration and the 3-year survival of dental implants placed with a conventional two-stage surgical protocol and without bone grafting. Therefore, it should not be considered a contraindication for dental implant placement. Copyright © 2017 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

Challenges in the Successful Research Management of a Collaborative EU Project.

PubMed

Zikos, Dimitrios; Diomidous, Marianna; Mantas, John

2012-03-01

Successful research management requirements include; equal teamwork and efficient coordination, in order to increase the impact of the research outcomes and provide added value knowledge. Aim of this paper is to discuss the strategies that have been followed during the RN4CAST study, the largest nursing multi-country research project ever conducted in Europe. The paper focuses on the core research strategies rather than on the administrative activities, which are inevitably also required for the success of a large scale research. This paper is an extension of a conference presentation in the International Conference of the European Federation for Medical Informatics (MIE) 2011 in Oslo, and was subsequently published in the Studies in Health Technology and Informatics book series (IOS Press) under the title "Research management: the case of RN4CAST." Management of a multicountry nursing survey requires the use of common data collection tools, applicable to every context, research protocols supporting the scope of the research, data models for multi-country analyses and global dissemination strategies. Challenges that may be faced during the implementation of the study include the individualized confrontation of obstacles during data collection, the coherence of national procedures (for example permissions for data collection) in European level, and the challenge to gain information of added value for the EU, by aggregating the national survey results through a powerful data analysis model. Communication strategies are also discussed.

Assessment of Adverse Events in Protocols, Clinical Study Reports, and Published Papers of Trials of Orlistat: A Document Analysis.

PubMed

Schroll, Jeppe Bennekou; Penninga, Elisabeth I; Gøtzsche, Peter C

2016-08-01

Little is known about how adverse events are summarised and reported in trials, as detailed information is usually considered confidential. We have acquired clinical study reports (CSRs) from the European Medicines Agency through the Freedom of Information Act. The CSRs describe the results of studies conducted as part of the application for marketing authorisation for the slimming pill orlistat. The purpose of this study was to study how adverse events were summarised and reported in study protocols, CSRs, and published papers of orlistat trials. We received the CSRs from seven randomised placebo controlled orlistat trials (4,225 participants) submitted by Roche. The CSRs consisted of 8,716 pages and included protocols. Two researchers independently extracted data on adverse events from protocols and CSRs. Corresponding published papers were identified on PubMed and adverse event data were extracted from this source as well. All three sources were compared. Individual adverse events from one trial were summed and compared to the totals in the summary report. None of the protocols or CSRs contained instructions for investigators on how to question participants about adverse events. In CSRs, gastrointestinal adverse events were only coded if the participant reported that they were "bothersome," a condition that was not specified in the protocol for two of the trials. Serious adverse events were assessed for relationship to the drug by the sponsor, and all adverse events were coded by the sponsor using a glossary that could be updated by the sponsor. The criteria for withdrawal due to adverse events were in one case related to efficacy (high fasting glucose led to withdrawal), which meant that one trial had more withdrawals due to adverse events in the placebo group. Finally, only between 3% and 33% of the total number of investigator-reported adverse events from the trials were reported in the publications because of post hoc filters, though six of seven papers stated that "all adverse events were recorded." For one trial, we identified an additional 1,318 adverse events that were not listed or mentioned in the CSR itself but could be identified through manually counting individual adverse events reported in an appendix. We discovered that the majority of patients had multiple episodes of the same adverse event that were only counted once, though this was not described in the CSRs. We also discovered that participants treated with orlistat experienced twice as many days with adverse events as participants treated with placebo (22.7 d versus 14.9 d, p-value < 0.0001, Student's t test). Furthermore, compared with the placebo group, adverse events in the orlistat group were more severe. None of this was stated in the CSR or in the published paper. Our analysis was restricted to one drug tested in the mid-1990s; our results might therefore not be applicable for newer drugs. In the orlistat trials, we identified important disparities in the reporting of adverse events between protocols, clinical study reports, and published papers. Reports of these trials seemed to have systematically understated adverse events. Based on these findings, systematic reviews of drugs might be improved by including protocols and CSRs in addition to published articles.

Ocean fertilization, carbon credits and the Kyoto Protocol

NASA Astrophysics Data System (ADS)

Westley, M. B.; Gnanadesikan, A.

2008-12-01

Commercial interest in ocean fertilization as a carbon sequestration tool was excited by the December 1997 agreement of the Kyoto Protocol to the United Nations Convention on Climate Change. The Protocol commits industrialized countries to caps on net greenhouse gas emissions and allows for various flexible mechanisms to achieve these caps in the most economically efficient manner possible, including trade in carbon credits from projects that reduce emissions or enhance sinks. The carbon market was valued at 64 billion in 2007, with the bulk of the trading (50 billion) taking place in the highly regulated European Union Emission Trading Scheme, which deals primarily in emission allowances in the energy sector. A much smaller amount, worth $265 million, was traded in the largely unregulated "voluntary" market (Capoor and Ambrosi 2008). As the voluntary market grows, so do calls for its regulation, with several efforts underway to set rules and standards for the sale of voluntary carbon credits using the Kyoto Protocol as a starting point. Four US-based companies and an Australian company currently seek to develop ocean fertilization technologies for the generation of carbon credits. We review these plans through the lens of the Kyoto Protocol and its flexible mechanisms, and examine whether and how ocean fertilization could generate tradable carbon credits. We note that at present, ocean sinks are not included in the Kyoto Protocol, and that furthermore, the Kyoto Protocol only addresses sources and sinks of greenhouse gases within national boundaries, making open-ocean fertilization projects a jurisdictional challenge. We discuss the negotiating history behind the limited inclusion of land use, land use change and forestry in the Kyoto Protocol and the controversy and eventual compromise concerning methodologies for terrestrial carbon accounting. We conclude that current technologies for measuring and monitoring carbon sequestration following ocean fertilization are unlikely to meet the Kyoto Protocol's verification and accounting standards for trading carbon credits on the regulated market. The marketability of ocean fertilization in the voluntary carbon marketplace will likely depend on companies' efforts to minimize environmental risks and consumers' willingness to accept remaining risks.

INRiM Time and Frequency Laboratory: A New Data Management System (DMS)

DTIC Science & Technology

2010-11-01

protocols defined at international level. The INRIM TFL, at present, is equipped with a set of measuring and control devices (SAD – Sistema di...Proceedings of the 22 th European Frequency and Time Forum (EFTF), 22-25 April 2008, Toulouse, France. [2] G. Vizio, 2000, “ Sistema per l’acquisizione...dei dati del Laboratorio di Tempo e Frequenza,” Manuale Operativo INRIM – 2000. [3] R. Costa, D. Orgiazzi, G. C. Cerretto, and V. Pettiti, 2010

Alert Exchange Process Protocol

NASA Technical Reports Server (NTRS)

Groen, Frank

2015-01-01

The National Aeronautics and Space Administration of the United States of America (NASA), and the European Space Agency (ESA), and the Japanese Aerospace Exploration Agency (JAXA), acknowledging that NASA, ESA and JAXA have a mutual interest in exchanging Alerts and Alert Status Lists to enhance the information base for each system participant while fortifying the general level of cooperation between the policy agreement subscribers, and each Party will exchange Alert listings on regular basis and detailed Alert information on a need to know basis to the extent permitted by law.

A European study investigating patterns of transition from home care towards institutional dementia care: the protocol of a RightTimePlaceCare study

PubMed Central

2012-01-01

Background Health care policies in many countries aim to enable people with dementia to live in their own homes as long as possible. However, at some point during the disease the needs of a significant number of people with dementia cannot be appropriately met at home and institutional care is required. Evidence as to best practice strategies enabling people with dementia to live at home as long as possible and also identifying the right time to trigger admission to a long-term nursing care facility is therefore urgently required. The current paper presents the rationale and methods of a study generating primary data for best-practice development in the transition from home towards institutional nursing care for people with dementia and their informal caregivers. The study has two main objectives: 1) investigate country-specific factors influencing institutionalization and 2) investigate the circumstances of people with dementia and their informal caregivers in eight European countries. Additionally, data for economic evaluation purposes are being collected. Methods/design This paper describes a prospective study, conducted in eight European countries (Estonia, Finland, France, Germany, Netherlands, Sweden, Spain, United Kingdom). A baseline assessment and follow-up measurement after 3 months will be performed. Two groups of people with dementia and their informal caregivers will be included: 1) newly admitted to institutional long-term nursing care facilities; and 2) receiving professional long-term home care, and being at risk for institutionalization. Data will be collected on outcomes for people with dementia (e.g. quality of life, quality of care), informal caregivers (e.g. caregiver burden, quality of life) and costs (e.g. resource utilization). Statistical analyses consist of descriptive and multivariate regression techniques and cross-country comparisons. Discussion The current study, which is part of a large European project 'RightTimePlaceCare', generates primary data on outcomes and costs of long-term nursing care for people with dementia and their informal caregivers, specifically focusing on the transition from home towards institutional care. Together with data collected in three other work packages, knowledge gathered in this study will be used to inform and empower patients, professionals, policy and related decision makers to manage and improve health and social dementia care services. PMID:22269343

Pre-Exposure Prophylaxis (PrEP) as an Additional Tool for HIV Prevention Among Men Who Have Sex With Men in Belgium: The Be-PrEP-ared Study Protocol.

PubMed

De Baetselier, Irith; Reyniers, Thijs; Nöstlinger, Christiana; Wouters, Kristien; Fransen, Katrien; Crucitti, Tania; Kenyon, Chris; Buyze, Jozefien; Schurmans, Céline; Laga, Marie; Vuylsteke, Bea

2017-01-30

Pre-exposure prophylaxis (PrEP) is a promising and effective tool to prevent HIV. With the approval of Truvada as daily PrEP by the European Commission in August 2016, individual European Member states prepare themselves for PrEP implementation following the examples of France and Norway. However, context-specific data to guide optimal implementation is currently lacking. With this demonstration project we evaluate whether daily and event-driven PrEP, provided within a comprehensive prevention package, is a feasible and acceptable additional prevention tool for men who have sex with men (MSM) at high risk of acquiring HIV in Belgium. The study's primary objective is to document the uptake, acceptability, and adherence to both daily and event-driven PrEP, while several secondary objectives have been formulated including impact of PrEP use on sexual behavior. The Be-PrEP-ared study is a phase 3, single-site, open-label prospective cohort study with a large social science component embedded in the trial. A total of 200 participants choose between daily or event-driven PrEP use and may switch, discontinue, or restart their regimen at the 3-monthly visits for a duration of 18 months. Data are collected on several platforms: an electronic case report form, a Web-based tool where participants register their sexual behavior and pill use, a more detailed electronic self-administered questionnaire completed during study visits on a tablet computer, and in-depth interviews among a selected sample of participants. To answer the primary objective, the recruitment rate, (un)safe sex behavior during the last 6 months, percentage of reported intention to use PrEP in the future, retention rates in different regimens, and attitudes towards PrEP use will be analyzed. Adherence will be monitored using self-reported adherence, pill count, tenofovir drug levels in blood samples, and the perceived skills to adhere. All participants are currently enrolled, and the last study visit is planned to take place around Q3 2018. As PrEP is not yet available in Belgium for use, this study will provide insights into how to optimally implement PrEP within the current health care provision and will shape national and European guidelines with regard to the place of PrEP in HIV prevention strategies. EU Clinical Trial 2015-000054-37; https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-000054-37/BE (Archived by WebCite at http://www.webcitation.org/6nacjSdmM). ©Irith De Baetselier, Thijs Reyniers, Christiana Nöstlinger, Kristien Wouters, Katrien Fransen, Tania Crucitti, Chris Kenyon, Jozefien Buyze, Céline Schurmans, Marie Laga, Bea Vuylsteke, Be-PrEP-Ared Study Group. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 30.01.2017.

Outcomes comparison of different surgical strategies for the management of severe aortic valve stenosis: study protocol of a prospective multicentre European registry (E-AVR registry)

PubMed Central

Onorati, Francesco; Gherli, Riccardo; Mariscalco, Giovanni; Girdauskas, Evaldas; Quintana, Eduardo; Santini, Francesco; De Feo, Marisa; Sponga, Sandro; Tozzi, Piergiorgio; Bashir, Mohamad; Perrotti, Andrea; Pappalardo, Aniello; Ruggieri, Vito Giovanni; Santarpino, Giuseppe; Rinaldi, Mauro; Ronaldo, Silva; Nicolini, Francesco

2018-01-01

Introduction Traditional and transcatheter surgical treatments of severe aortic valve stenosis (SAVS) are increasing in parallel with the improved life expectancy. Recent randomised controlled trials (RCTs) reported comparable or non-inferior mortality with transcatheter treatments compared with traditional surgery. However, RCTs have the limitation of being a mirror of the predefined inclusion/exclusion criteria, without reflecting the ‘real clinical world’. Technological improvements have recently allowed the development of minimally invasive surgical accesses and the use of sutureless valves, but their impact on the clinical scenario is difficult to assess because of the monocentric design of published studies and limited sample size. A prospective multicentre registry including all patients referred for a surgical treatment of SAVS (traditional, through full sternotomy; minimally invasive; or transcatheter; with both ‘sutured’ and ‘sutureless’ valves) will provide a ‘real-world’ picture of available results of current surgical options and will help to clarify the ‘grey zones’ of current guidelines. Methods and analysis European Aortic Valve Registry is a prospective observational open registry designed to collect all data from patients admitted for SAVS, with or without coronary artery disease, in 16 cardiac surgery centres located in six countries (France, Germany, Italy, Spain, Switzerland and UK). Patients will be enrolled over a 2-year period and followed up for a minimum of 5 years to a maximum of 10 years after enrolment. Outcome definitions are concordant with Valve Academic Research Consortium-2 criteria and established guidelines. Primary outcome is 5-year all-cause mortality. Secondary outcomes aim at establishing ‘early’ 30-day all-cause and cardiovascular mortality, as well as major morbidity, and ‘late’ cardiovascular mortality, major morbidity, structural and non-structural valve complications, quality of life and echocardiographic results. Ethics and dissemination The study protocol is approved by local ethics committees. Any formal presentation or publication of data will be considered as a joint publication by the participating physician(s) and will follow the recommendations of the International Committee of Medical Journal Editors for authorship. Trial registration number NCT03143361; Pre-results. PMID:29440154

Towards new methods for the determination of dose limiting toxicities and the assessment of the recommended dose for further studies of molecularly targeted agents--dose-Limiting Toxicity and Toxicity Assessment Recommendation Group for Early Trials of Targeted therapies, an European Organisation for Research and Treatment of Cancer-led study.

PubMed

Postel-Vinay, Sophie; Collette, Laurence; Paoletti, Xavier; Rizzo, Elisa; Massard, Christophe; Olmos, David; Fowst, Camilla; Levy, Bernard; Mancini, Pierre; Lacombe, Denis; Ivy, Percy; Seymour, Lesley; Le Tourneau, Christophe; Siu, Lillian L; Kaye, Stan B; Verweij, Jaap; Soria, Jean-Charles

2014-08-01

Traditional dose-limiting toxicity (DLT) definition, which uses grade (G) 3-4 toxicity data from cycle 1 (C1) only, may not be appropriate for molecularly targeted agents (MTAs) of prolonged administration, for which late or lower grade toxicities also deserve attention. In collaboration with pharmaceutical companies and academia, an European Organisation for Research and Treatment of Cancer (EORTC)-led initiative, Dose-Limiting Toxicity and Toxicity Assessment Recommendation Group for Early Trials of Targeted therapies (DLT-TARGETT), collected data from completed phase 1 trials evaluating MTAs as monotherapy. All toxicities at least possibly related to the study drugs that occurred during C1-6, their type, grade (CTCAEv3.0), and duration as well as patients' relative dose-intensity (RDI), were recorded. The 54 eligible trials enrolled 2084 evaluable adult patients with solid tumours between 1999 and 2013, and evaluated small molecules (40), antibodies (seven), recombinant peptides (five) and antisense oligodeoxynucleotides (two). A maximum tolerated dose was set in 43 trials. Fifteen percent of the patients received <75% of the intended RDI in C1, but only 9.1% of them presented protocol-defined DLTs. After C1, 16-19% of patients received <75% of the intended RDI. A similar proportion of G ⩾ 3 toxicities was recorded in C1 and after C1 (936 and 1087 toxicities, respectively), with the first G⩾3 toxicity occurring after C1 in 18.6% of patients. Although protocol-defined DLT period is traditionally limited to C1, almost 20% of patients present significant reductions in RDI at any time in phase 1 trials of MTAs. Recommended phase 2 dose assessment should incorporate all available information from any cycle (notably lower grade toxicities leading to such RDI decrease), and be based on achieving >75% RDI. Copyright © 2014 Elsevier Ltd. All rights reserved.

Clinical characteristics of patients with spinocerebellar ataxias 1, 2, 3 and 6 in the US; a prospective observational study

PubMed Central

2013-01-01

Background All spinocerebellar ataxias (SCAs) are rare diseases. SCA1, 2, 3 and 6 are the four most common SCAs, all caused by expanded polyglutamine-coding CAG repeats. Their pathomechanisms are becoming increasingly clear and well-designed clinical trials will be needed. Methods To characterize the clinical manifestations of spinocerebellar ataxia (SCA) 1, 2, 3 and 6 and their natural histories in the United States (US), we conducted a prospective multicenter study utilized a protocol identical to the European consortium study, using the Scale for the Assessment and Rating of Ataxia (SARA) score as the primary outcome, with follow-ups every 6 months up to 2 years. Results We enrolled 345 patients (60 SCA1, 75 SCA2, 138 SCA3 and 72 SCA6) at 12 US centers. SCA6 patients had a significantly later onset, and SCA2 patients showed greater upper-body ataxia than patients with the remaining SCAs. The annual increase of SARA score was greater in SCA1 patients (mean ± SE: 1.61 ± 0.41) than in SCA2 (0.71 ± 0.31), SCA3 (0.65 ± 0.24) and SCA6 (0.87 ± 0.28) patients (p = 0.049). The functional stage also worsened faster in SCA1 than in SCA2, 3 and 6 (p = 0.002). Conclusions The proportions of different SCA patients in US differ from those in the European consortium study, but as in the European patients, SCA1 progress faster than those with SCA2, 3 and 6. Later onset in SCA6 and greater upper body ataxia in SCA2 were noted. We conclude that progression rates of these SCAs were comparable between US and Europe cohorts, suggesting the feasibility of international collaborative clinical studies. PMID:24225362

InternationaL cross-sectIonAl and longItudinal assessment on aSthma cONtrol in European adult patients - the LIAISON study protocol

PubMed Central

2013-01-01

Background According to international guidelines, the goal of asthma management is to achieve and maintain control of the disease, which can be assessed using composite measures. Prospective studies are required to determine how these measures are associated with asthma outcomes and/or future risk. The ‘InternationaL cross-sectIonAl and longItudinal assessment on aSthma cONtrol (LIAISON)’ observational study has been designed to evaluate asthma control and its determinants, including components of asthma management. Methods/design The LIAISON study will be conducted in 12 European countries and comprises a cross-sectional phase and a 12-month prospective phase. Both phases will aim at assessing asthma control (six-item Asthma Control Questionnaire, ACQ), asthma-related quality of life (Mini Asthma Quality of Life Questionnaire, Mini-AQLQ), risk of non-adherence to treatment (four-item Morisky Medication Adherence Scale, MMAS-4), potential reasons for poor control, treatment strategies and associated healthcare costs. The cross-sectional phase will recruit > 8,000 adult patients diagnosed with asthma for at least 6 months and receiving the same asthma treatment in the 4 weeks before enrolment. The prospective phase will include all patients with uncontrolled/poorly controlled asthma at the initial visit to assess the proportion reaching control during follow-up and to examine predictors of future risk. Visits will take place after 3, 6 and 12 months. Discussion The LIAISON study will provide important information on the prevalence of asthma control and on the quality of life in a broad spectrum of real-life patient populations from different European countries and will also contribute to evaluate differences in management strategies and their impact on healthcare costs over 12 months of observation. Trial registration ClinicalTrials.gov identifier, NCT01567280. PMID:23530817

Does surgical sympathectomy improve clinical outcomes in patients with refractory angina pectoris?

PubMed

Holland, Luke C; Navaratnarajah, Manoraj; Taggart, David P

2016-04-01

A best evidence topic in cardiothoracic surgery was written according to a structured protocol. The question addressed was: In patients with angina pectoris refractory to medical therapy, does surgical sympathectomy improve clinical outcomes? A total of 528 papers were identified using the search protocol described, of which 6 represented the best evidence to answer the clinical question. There were 5 case series and 1 prospective cohort study. The authors, journal, date and country of publication, patient group studied, study type, relevant outcomes and results of these papers are tabulated. All 5 of the case series demonstrated an improvement in symptoms, exercise tolerance or quality of life in patients undergoing surgical sympathectomy. An early case series investigating an open approach had a high morbidity and mortality rate, but the 4 other series used a minimally invasive technique and had low morbidity and zero perioperative mortality rates. The cohort study compared surgical sympathectomy with transmyocardial laser revascularization (TMR) and concluded TMR to be superior. However, this study looked only at unilateral sympathectomy, whereas all 5 case series focused on bilateral surgery. We conclude that the best currently available evidence does suggest that patients report an improvement in their symptoms and quality of life following surgical sympathectomy, but the low level of this evidence does not allow for a statistically proved recommendation. © The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Age dependency of primary tumor sites and metastases in patients with Ewing sarcoma.

PubMed

Worch, Jennifer; Ranft, Andreas; DuBois, Steven G; Paulussen, Michael; Juergens, Heribert; Dirksen, Uta

2018-06-01

The median age of patients with Ewing sarcoma (EwS) at diagnosis is around 14-15 years. Older age is associated with a worse outcome. The correlation of age at diagnosis on sites of disease has not been fully described. The goal of this study was to evaluate the differences in sites of primary tumor and metastatic tumor involvement according to age groups. EwS data from the Gesellschaft für Pädiatrische Onkologie und Hämatology (GPOH) database of the Cooperative Ewing Sarcoma Study (CESS) 81/86 and the European Intergroup Cooperative Ewing's Sarcoma Study EICESS 92 and the EUROpean Ewing tumor Working Initiative of National Groups-99-Protocol (EURO-E.W.I.N.G.-99) study were analyzed. Patient and tumor characteristics were evaluated statistically using chi square tests. The study population included 2,635 patients with bone EwS. Sites of primary and metastatic tumors differed according to the age groups of young children (0-9 years), early adolescence (10-14 years), late adolescence (15-19 years), young adults (20-24 years), and adults (more than 24 years). Young children demonstrated the most striking differences in site of disease with a lower proportion of pelvic primary and axial tumors. They presented less often with metastatic disease at diagnosis. Site of primary and metastatic tumor involvement in EwS differs according to patient age. The biological and developmental etiology for these differences requires further investigations. © 2018 Wiley Periodicals, Inc.

Osteosarcoma: the European Osteosarcoma Intergroup (EOI) perspective.

PubMed

Craft, Alan W

2009-01-01

In the late 1970s, there was confusion regarding the best management for osteosarcoma. The benefit of chemotherapy had not been established and which chemotherapy could be used was even more uncertain. The European Osteosarcoma Intergroup (EOI) was established in order to conduct randomised studies to determine the best treatment for this tumour. Their first study 80831 established that a two drug combination of CDDP/DOX was safe and improved the survival rate over previous regimes with suboptimal chemotherapy. The CDDP/DOX was superior to a less intense CDDP/DOX/MTX regime. The second study 80861 compared the CDDP/DOX arm with a multi-drug Rosen-T10 regime. In almost 400 patients, there was the difference in outcome between the two arms. However, adherence to the protocol and completion of allocated treatment was substantially less good in the prolonged 42 week multi-drug regime compared to the two drug arm. The third study 80961 investigated interval compression i.e. if the CDDP/DOX when given every 2 weeks with GCSF superior to the same two drugs given every 3 weeks. There was no difference in survival between the arms, although there was a better histologic response rate in the compressed arm. Three randomised controlled trials on this rare disease have taken more than 20 years to accrue a sufficient sample of patients. The overall outcome has changed little in this time. Large multinational studies are needed to be able to answer these important questions in a timely fashion.

Better cancer biomarker discovery through better study design.

PubMed

Rundle, Andrew; Ahsan, Habibul; Vineis, Paolo

2012-12-01

High-throughput laboratory technologies coupled with sophisticated bioinformatics algorithms have tremendous potential for discovering novel biomarkers, or profiles of biomarkers, that could serve as predictors of disease risk, response to treatment or prognosis. We discuss methodological issues in wedding high-throughput approaches for biomarker discovery with the case-control study designs typically used in biomarker discovery studies, especially focusing on nested case-control designs. We review principles for nested case-control study design in relation to biomarker discovery studies and describe how the efficiency of biomarker discovery can be effected by study design choices. We develop a simulated prostate cancer cohort data set and a series of biomarker discovery case-control studies nested within the cohort to illustrate how study design choices can influence biomarker discovery process. Common elements of nested case-control design, incidence density sampling and matching of controls to cases are not typically factored correctly into biomarker discovery analyses, inducing bias in the discovery process. We illustrate how incidence density sampling and matching of controls to cases reduce the apparent specificity of truly valid biomarkers 'discovered' in a nested case-control study. We also propose and demonstrate a new case-control matching protocol, we call 'antimatching', that improves the efficiency of biomarker discovery studies. For a valid, but as yet undiscovered, biomarker(s) disjunctions between correctly designed epidemiologic studies and the practice of biomarker discovery reduce the likelihood that true biomarker(s) will be discovered and increases the false-positive discovery rate. © 2012 The Authors. European Journal of Clinical Investigation © 2012 Stichting European Society for Clinical Investigation Journal Foundation.

Improving survival and storage stability of bacteria recalcitrant to freeze-drying: a coordinated study by European culture collections.

PubMed

Peiren, Jindrich; Buyse, Joke; De Vos, Paul; Lang, Elke; Clermont, Dominique; Hamon, Sylviane; Bégaud, Evelyne; Bizet, Chantal; Pascual, Javier; Ruvira, María A; Macián, M Carmen; Arahal, David R

2015-04-01

The objective of this study is to improve the viability after freeze-drying and during storage of delicate or recalcitrant strains safeguarded at biological resource centers. To achieve this objective, a joint experimental strategy was established among the different involved partner collections of the EMbaRC project ( www.embarc.eu ). Five bacterial strains considered as recalcitrant to freeze-drying were subjected to a standardized freeze-drying protocol and to seven agreed protocol variants. Viability of these strains was determined before and after freeze-drying (within 1 week, after 6 and 12 months, and after accelerated storage) for each of the protocols. Furthermore, strains were exchanged between partners to perform experiments with different freeze-dryer-dependent parameters. Of all tested variables, choice of the lyoprotectant had the biggest impact on viability after freeze-drying and during storage. For nearly all tested strains, skim milk as lyoprotectant resulted in lowest viability after freeze-drying and storage. On the other hand, best freeze-drying and storage conditions were strain and device dependent. For Aeromonas salmonicida CECT 894(T), best survival was obtained when horse serum supplemented with trehalose was used as lyoprotectant, while Aliivibrio fischeri LMG 4414(T) should be freeze-dried in skim milk supplemented with marine broth in a 1:1 ratio. Freeze-drying Campylobacter fetus CIP 53.96(T) using skim milk supplemented with trehalose as lyoprotectant resulted in best recovery. Xanthomonas fragariae DSM 3587(T) expressed high viability after freeze-drying and storage for all tested lyoprotectants and could not be considered as recalcitrant. In contrary, Flavobacterium columnare LMG 10406(T) did not survive the freeze-drying process under all tested conditions.

Development of a new protocol for rapid bacterial identification and susceptibility testing directly from urine samples.

PubMed

Zboromyrska, Y; Rubio, E; Alejo, I; Vergara, A; Mons, A; Campo, I; Bosch, J; Marco, F; Vila, J

2016-06-01

The current gold standard method for the diagnosis of urinary tract infections (UTI) is urine culture that requires 18-48 h for the identification of the causative microorganisms and an additional 24 h until the results of antimicrobial susceptibility testing (AST) are available. The aim of this study was to shorten the time of urine sample processing by a combination of flow cytometry for screening and matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF-MS) for bacterial identification followed by AST directly from urine. The study was divided into two parts. During the first part, 675 urine samples were processed by a flow cytometry device and a cut-off value of bacterial count was determined to select samples for direct identification by MALDI-TOF-MS at ≥5 × 10(6) bacteria/mL. During the second part, 163 of 1029 processed samples reached the cut-off value. The sample preparation protocol for direct identification included two centrifugation and two washing steps. Direct AST was performed by the disc diffusion method if a reliable direct identification was obtained. Direct MALDI-TOF-MS identification was performed in 140 urine samples; 125 of the samples were positive by urine culture, 12 were contaminated and 3 were negative. Reliable direct identification was obtained in 108 (86.4%) of the 125 positive samples. AST was performed in 102 identified samples, and the results were fully concordant with the routine method among 83 monomicrobial infections. In conclusion, the turnaround time of the protocol described to diagnose UTI was about 1 h for microbial identification and 18-24 h for AST. Copyright © 2016 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

Current practices in long-term video-EEG monitoring services: A survey among partners of the E-PILEPSY pilot network of reference for refractory epilepsy and epilepsy surgery.

PubMed

Kobulashvili, Teia; Höfler, Julia; Dobesberger, Judith; Ernst, Florian; Ryvlin, Philippe; Cross, J Helen; Braun, Kees; Dimova, Petia; Francione, Stefano; Hecimovic, Hrvoje; Helmstaedter, Christoph; Kimiskidis, Vasilios K; Lossius, Morten Ingvar; Malmgren, Kristina; Marusic, Petr; Steinhoff, Bernhard J; Boon, Paul; Craiu, Dana; Delanty, Norman; Fabo, Daniel; Gil-Nagel, Antonio; Guekht, Alla; Hirsch, Edouard; Kalviainen, Reetta; Mameniskiené, Ruta; Özkara, Çiğdem; Seeck, Margitta; Rubboli, Guido; Krsek, Pavel; Rheims, Sylvain; Trinka, Eugen

2016-05-01

The European Union-funded E-PILEPSY network aims to improve awareness of, and accessibility to, epilepsy surgery across Europe. In this study we assessed current clinical practices in epilepsy monitoring units (EMUs) in the participating centers. A 60-item web-based survey was distributed to 25 centers (27 EMUs) of the E-PILEPSY network across 22 European countries. The questionnaire was designed to evaluate the characteristics of EMUs, including organizational aspects, admission, and observation of patients, procedures performed, safety issues, cost, and reimbursement. Complete responses were received from all (100%) EMUs surveyed. Continuous observation of patients was performed in 22 (81%) EMUs during regular working hours, and in 17 EMUs (63%) outside of regular working hours. Fifteen (56%) EMUs requested a signed informed consent before admission. All EMUs performed tapering/withdrawal of antiepileptic drugs, 14 (52%) prior to admission to an EMU. Specific protocols on antiepileptic drugs (AED) tapering were available in four (15%) EMUs. Standardized Operating Procedures (SOP) for the treatment of seizure clusters and status epilepticus were available in 16 (59%). Safety measures implemented by EMUs were: alarm seizure buttons in 21 (78%), restricted patient's ambulation in 19 (70%), guard rails in 16 (59%), and specially designated bathrooms in 7 (26%). Average costs for one inpatient day in EMU ranged between 100 and 2200 Euros. This study shows a considerable diversity in the organization and practice patterns across European epilepsy monitoring units. The collected data may contribute to the development and implementation of evidence-based recommended practices in LTM services across Europe. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

Classification of pregnancies of unknown location according to four different hCG-based protocols.

PubMed

Fistouris, J; Bergh, C; Strandell, A

2016-10-01

How do four protocols based on serial human chorionic gonadotropin (hCG) measurements perform when classifying pregnancies of unknown location (PULs) as low or high risk of being an ectopic pregnancy (EP)? The use of cut-offs in hCG level changes published by NICE, and a logistic regression model, M4, correctly classify more PULs as high risk, compared with two other protocols. A logistic regression model, M4, based on the mean of two consecutive hCG values and the hCG ratio (hCG 48 h/hCG 0 h) that classify PULs into low- and high-risk groups for triage purposes, identifies more EPs than a protocol using the cut-offs between a 13% decline and a 66% rise in hCG levels over 48 h. A retrospective comparative study of four different hCG-based protocols classifying PULs as low or high risk of being an EP was performed at a gynaecological emergency unit over 3 years. We identified 915 women with a PUL. Initial transvaginal ultrasonography (TVS) findings categorised 187 of the PULs as probable intrauterine pregnancies (IUPs) and 16 as probable EPs. The rate of change in hCG levels over 48 h was calculated for each patient and subjected to three different hCG threshold intervals and a logistic regression model for outcome prediction. Each PUL was subsequently dichotomised to either low-risk (i.e. failed PUL/IUP) or high-risk (i.e. EP) classification, which allowed us to compare the diagnostic performance. In 'Protocol A', a PUL was classified as low risk if >13% hCG level decline or >66% hCG level rise was achieved; otherwise, the PUL was classified as high risk of being an EP. 'Protocol B' classified a PUL as low or high risk using cut-offs of 35-50% declining hCG levels and of 53% rising hCG levels. Similarly, 'Protocol C' used hCG level cut-offs published by NICE, 50% for declining hCG levels and 63% for rising hCG levels. Finally, if a logistic regression model 'Protocol M4' calculated a ≥5% risk of the PUL being an EP, it was classified as high risk, and otherwise the PUL was classified as low risk. When the time interval between two hCG measurements failed to meet an exact 48 h, extrapolation and interpolation of hCG values was made, using log linear transformation. Protocols A, B, C and M4 classified 73, 66, 55 and 56% of PULs as low risk. The sensitivity for protocols A, B, C and M4 was 68% (95% confidence interval (CI) 61-75%), 81% (74-86%), 87% (82-92%) and 88% (83-93%), respectively. The specificity was 82% (80-85%), 77% (74-80%), 66% (62-69%) and 67% (63-70%) for protocols A, B, C and M4, respectively. All comparisons of sensitivity and specificity between the protocols were statistically significant except for protocol C versus protocol M4. In protocol C, 87% (66-97%) of misclassified EPs had rising hCG levels, compared with 19% (6-41%) for protocol M4 (P < 0.01). In a secondary analysis excluding probable IUPs and probable EPs, the results for 712 PULs were analysed. The sensitivity subsequently remained stable for all protocols. Protocol M4 reached a 78% (74-81%) specificity, which was significantly higher than 70% (66-74%) for protocol C (P = 0.01) and protocol M4 classified 63% of PULs as low risk compared with 58% for protocol C. The retrospective design of the study is a limitation. The results are derived from a population where laparoscopy played an important role in PUL management and diagnosis of EPs, although it did reflect real clinical practice. Although we tried to adhere to definitions of PUL and final outcomes as in previous studies and a recent consensus statement, potential differences in this regard must be acknowledged. Where the time interval between two serial hCG measurements deviated from 48 h we estimated 48 h hCG values. A logistic regression model, M4, classifies more PULs correctly as low risk in a selected PUL population without probable IUPs and EPs and identifies as many EPs, in comparison with the cut-offs available in the NICE guideline. This advantage for model M4 may result in a reduction of unnecessary follow-up visits, when fewer low-risk PULs are misclassified as high risk. These findings, however, ought to be clarified in a randomised controlled trial. The study was supported by LUA/ALF grant No. 70940. There are no competing interests. © The Author 2016. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Guidelines for surveillance of individuals with constitutional mismatch repair-deficiency proposed by the European Consortium "Care for CMMR-D" (C4CMMR-D).

PubMed

Vasen, H F A; Ghorbanoghli, Z; Bourdeaut, F; Cabaret, O; Caron, O; Duval, A; Entz-Werle, N; Goldberg, Y; Ilencikova, D; Kratz, C P; Lavoine, N; Loeffen, J; Menko, F H; Muleris, M; Sebille, G; Colas, C; Burkhardt, B; Brugieres, L; Wimmer, K

2014-05-01

Lynch syndrome (LS) is an autosomal dominant disorder caused by a defect in one of the DNA mismatch repair genes: MLH1, MSH2, MSH6 and PMS2. In the last 15 years, an increasing number of patients have been described with biallelic mismatch repair gene mutations causing a syndrome referred to as 'constitutional mismatch repair-deficiency' (CMMR-D). The spectrum of cancers observed in this syndrome differs from that found in LS, as about half develop brain tumours, around half develop digestive tract cancers and a third develop haematological malignancies. Brain tumours and haematological malignancies are mainly diagnosed in the first decade of life, and colorectal cancer (CRC) and small bowel cancer in the second and third decades of life. Surveillance for CRC in patients with LS is very effective. Therefore, an important question is whether surveillance for the most common CMMR-D-associated cancers will also be effective. Recently, a new European consortium was established with the aim of improving care for patients with CMMR-D. At a workshop of this group held in Paris in June 2013, one of the issues addressed was the development of surveillance guidelines. In 1968, criteria were proposed by WHO that should be met prior to the implementation of screening programmes. These criteria were used to assess surveillance in CMMR-D. The evaluation showed that surveillance for CRC is the only part of the programme that largely complies with the WHO criteria. The values of all other suggested screening protocols are unknown. In particular, it is questionable whether surveillance for haematological malignancies improves the already favourable outcome for patients with these tumours. Based on the available knowledge and the discussions at the workshop, the European consortium proposed a surveillance protocol. Prospective collection of all results of the surveillance is needed to evaluate the effectiveness of the programme.

A real-time polymerase chain reaction-based protocol for low/medium-throughput Y-chromosome microdeletions analysis.

PubMed

Segat, Ludovica; Padovan, Lara; Doc, Darja; Petix, Vincenzo; Morgutti, Marcello; Crovella, Sergio; Ricci, Giuseppe

2012-12-01

We describe a real-time polymerase chain reaction (PCR) protocol based on the fluorescent molecule SYBR Green chemistry, for a low- to medium-throughput analysis of Y-chromosome microdeletions, optimized according to the European guidelines and aimed at making the protocol faster, avoiding post-PCR processing, and simplifying the results interpretation. We screened 156 men from the Assisted Reproduction Unit, Department of Obstetrics and Gynecology, Institute for Maternal and Child Health IRCCS Burlo Garofolo (Trieste, Italy), 150 not presenting Y-chromosome microdeletion, and 6 with microdeletions in different azoospermic factor (AZF) regions. For each sample, the Zinc finger Y-chromosomal protein (ZFY), sex-determining region Y (SRY), sY84, sY86, sY127, sY134, sY254, and sY255 loci were analyzed by performing one reaction for each locus. AZF microdeletions were successfully detected in six individuals, confirming the results obtained with commercial kits. Our real-time PCR protocol proved to be a rapid, safe, and relatively cheap method that was suitable for a low- to medium-throughput diagnosis of Y-chromosome microdeletion, which allows an analysis of approximately 10 samples (with the addition of positive and negative controls) in a 96-well plate format, or approximately 46 samples in a 384-well plate for all markers simultaneously, in less than 2 h without the need of post-PCR manipulation.

The WISECARE Project and the impact of information technology on nursing knowledge.

PubMed

Sermeus, W; Hoy, D; Jodrell, N; Hyslop, A; Gypen, T; Kinnunen, J; Mantas, J; Delesie, L; Tansley, J; Hofdijk, J

1997-01-01

The European Union retained the WISECARE project "Work flow Information Systems for European nursing CARE" for funding. The project focuses on the use of telematics technology for clinical and resource management in oncology care in hospitals. This paper outlines the impact of introducing this kind of advanced nursing informatics application on the management of nursing knowledge. Three shift in knowledge management that will get high attention in WISECARE, are identified. The first is the shift from knowledge dissemination to knowledge sharing. The second is the shift from individual knowledge to organisational knowledge. The third is the shift from deductive, prescriptive knowledge as seen in guidelines, protocols to more inductive, experience based knowledge. The paper emphasizes that the real impact of information technology is not in the automation of existing processes but on the discovery of new ways of organisation and living.

Laboratory activities involving transmissible spongiform encephalopathy causing agents

PubMed Central

Leunda, Amaya; Van Vaerenbergh, Bernadette; Baldo, Aline; Roels, Stefan; Herman, Philippe

2013-01-01

Since the appearance in 1986 of epidemic of bovine spongiform encephalopathy (BSE), a new form of neurological disease in cattle which also affected human beings, many diagnostic and research activities have been performed to develop detection and therapeutic tools. A lot of progress was made in better identifying, understanding and controlling the spread of the disease by appropriate monitoring and control programs in European countries. This paper reviews the recent knowledge on pathogenesis, transmission and persistence outside the host of prion, the causative agent of transmissible spongiform encephalopathies (TSE) in mammals with a particular focus on risk (re)assessment and management of biosafety measures to be implemented in diagnostic and research laboratories in Belgium. Also, in response to the need of an increasing number of European diagnostic laboratories stopping TSE diagnosis due to a decreasing number of TSE cases reported in the last years, decontamination procedures and a protocol for decommissioning TSE diagnostic laboratories is proposed. PMID:24055928

Testing the extended biotic index in Slovakia: consistency, advantages, and limitations versus the saprobic assessment method of water quality.

PubMed

Pennelli, Bruno; Nagel, Karl-Otto; Crivellaro, Giuseppe; Fabiani, Claudio; Vancova, Alexandra; Mancini, Laura

2006-04-01

The European Union Water Framework Directive requires the achievement of environmental objectives for the ecological quality of water bodies. A comparable implementation of the Directive throughout member countries of the European Union is necessary to verify equal protection of surface waters. The Directive specifies that member states determine ecological quality by means of biological indices. To improve comparability of water quality assessment, this research carried out an intercalibration trial between the Slovak Saprobic Index and the Italian protocol of the Extended Biotic Index, as part of a cooperative program between Italy and the Slovak Republic. When assessing streams with no or low pollution, statistics showed similar results for both methods. In contrast, the comparison of indices was not accurate in the case of severely affected waters. Reliable conversion formulas are feasible to transform the Italian Extended Biotic Index into the Slovak Saprobic Index, and not vice versa.

New Regional and Global HFC Projections and Effects of National Regulations and Montreal Protocol Amendment Proposals

NASA Astrophysics Data System (ADS)

Velders, G. J. M.

2015-12-01

Hydrofluorocarbons (HFCs) are used as substitutes for ozone-depleting substances that are being phased out globally under Montreal Protocol regulations. New global scenarios of HFC emissions reach 4.0-5.3 GtCO2-eq yr-1 in 2050, which corresponds to a projected growth from 2015 to 2050 which is 9% to 29% of that for CO2 over the same time period. New baseline scenarios are formulated for 10 HFC compounds, 11 geographic regions, and 13 use categories. These projections are the first to comprehensively assess production and consumption of individual HFCs in multiple use sectors and geographic regions with emission estimates constrained by atmospheric observations. In 2050, in percent of global HFC emissions, China (~30%), India and the rest of Asia (~25%), Middle East and northern Africa (~10%), and USA (~10%) are the principal source regions; and refrigeration and stationary air conditioning are the major use sectors. National regulations to limit HFC use have been adopted recently in the European Union, Japan and USA, and four proposals have been submitted in 2015 to amend the Montreal Protocol to substantially reduce growth in HFC use. Calculated baseline emissions are reduced by 90% in 2050 by implementing the North America Montreal Protocol amendment proposal. Global adoption of technologies required to meet national regulations would be sufficient to reduce 2050 baseline HFC consumption by more than 50% of that achieved with the North America proposal for most developed and developing countries. The new HFC scenarios and effects of national regulations and Montreal Protocol amendment proposals will be presented.

European consensus on the medical management of acute radiation syndrome and analysis of the radiation accidents in Belgium and Senegal.

PubMed

Gourmelon, Patrick; Benderitter, Marc; Bertho, Jean Marc; Huet, Christelle; Gorin, Norbert Claude; De Revel, Patrick

2010-06-01

A European consensus concerning the medical management of mass radiation exposure was obtained in 2005 during a conference held by the European Group for Blood and Bone Marrow Transplantation, the Institute of Radioprotection and Nuclear Safety, and the University of Ulm. At the conference, a two-step triage strategy to deal with large masses of radiation-exposed patients was designed. The first step of this strategy concerns the first 48 h and involves scoring the patients exclusively on the basis of their clinical symptoms and biological data. This allows the non-irradiated bystanders and outpatient candidates to be identified. The remaining patients are hospitalized and diagnosis is confirmed after the first 48-h period according to the METREPOL (Medical Treatment Protocols for radiation accident victims) scale. This grades the patients according to the severity of their symptoms. It was also agreed that in the case of acute radiation syndrome (ARS), emergency hematopoietic stem cell (HSC) transplantation is not necessary. Instead, cytokines that promote hematological reconstruction should be administered as early as possible for 14-21 d. Crucial tests for determining whether the patient has residual hematopoiesis are physical dose reconstructions combined with daily blood count analyses. It was agreed that HSC transplantation should only be considered if severe aplasia persists after cytokine treatment. Two recent cases of accidental radiation exposure that were managed successfully by following the European consensus with modification are reviewed here. Thus, a European standard for the evaluation and treatment of ARS victims is now available. This standard may be suitable for application around the world.

Video Tracking Protocol to Screen Deterrent Chemistries for Honey Bees.

PubMed

Larson, Nicholas R; Anderson, Troy D

2017-06-12

The European honey bee, Apis mellifera L., is an economically and agriculturally important pollinator that generates billions of dollars annually. Honey bee colony numbers have been declining in the United States and many European countries since 1947. A number of factors play a role in this decline, including the unintentional exposure of honey bees to pesticides. The development of new methods and regulations are warranted to reduce pesticide exposures to these pollinators. One approach is the use of repellent chemistries that deter honey bees from a recently pesticide-treated crop. Here, we describe a protocol to discern the deterrence of honey bees exposed to select repellent chemistries. Honey bee foragers are collected and starved overnight in an incubator 15 h prior to testing. Individual honey bees are placed into Petri dishes that have either a sugar-agarose cube (control treatment) or sugar-agarose-compound cube (repellent treatment) placed into the middle of the dish. The Petri dish serves as the arena that is placed under a camera in a light box to record the honey bee locomotor activities using video tracking software. A total of 8 control and 8 repellent treatments were analyzed for a 10 min period with each treatment was duplicated with new honey bees. Here, we demonstrate that honey bees are deterred from the sugar-agarose cubes with a compound treatment whereas honey bees are attracted to the sugar-agarose cubes without an added compound.

Protocols for the analytical characterization of therapeutic monoclonal antibodies. II - Enzymatic and chemical sample preparation.

PubMed

Bobaly, Balazs; D'Atri, Valentina; Goyon, Alexandre; Colas, Olivier; Beck, Alain; Fekete, Szabolcs; Guillarme, Davy

2017-08-15

The analytical characterization of therapeutic monoclonal antibodies and related proteins usually incorporates various sample preparation methodologies. Indeed, quantitative and qualitative information can be enhanced by simplifying the sample, thanks to the removal of sources of heterogeneity (e.g. N-glycans) and/or by decreasing the molecular size of the tested protein by enzymatic or chemical fragmentation. These approaches make the sample more suitable for chromatographic and mass spectrometric analysis. Structural elucidation and quality control (QC) analysis of biopharmaceutics are usually performed at intact, subunit and peptide levels. In this paper, general sample preparation approaches used to attain peptide, subunit and glycan level analysis are overviewed. Protocols are described to perform tryptic proteolysis, IdeS and papain digestion, reduction as well as deglycosylation by PNGase F and EndoS2 enzymes. Both historical and modern sample preparation methods were compared and evaluated using rituximab and trastuzumab, two reference therapeutic mAb products approved by Food and Drug Administration (FDA) and European Medicines Agency (EMA). The described protocols may help analysts to develop sample preparation methods in the field of therapeutic protein analysis. Copyright © 2017 Elsevier B.V. All rights reserved.

Scientific Considerations for Evaluating Cancer Bioassays Conducted by the Ramazzini Institute

PubMed Central

Caldwell, Jane C.; Jinot, Jennifer; Evans, Marina V.; Cote, Ila; Vandenberg, John J.

2013-01-01

Background: The Ramazzini Institute (RI) has completed nearly 400 cancer bioassays on > 200 compounds. The European Food Safety Authority (EFSA) and others have suggested that study design and protocol differences between the RI and other laboratories by may contribute to controversy regarding cancer hazard findings, principally findings on lymphoma/leukemia diagnoses. Objective: We aimed to evaluate RI study design, protocol differences, and accuracy of tumor diagnoses for their impact on carcinogenic hazard characterization. Methods: We analyzed the findings from a recent Pathology Working Group (PWG) review of RI procedures and tumor diagnoses, evaluated consistency of RI and other laboratory findings for chemicals identified by the RI as positive for lymphoma/leukemia, and examined evidence for a number of other issues raised regarding RI bioassays. The RI cancer bioassay design and protocols were evaluated in the context of relevant risk assessment guidance from international authorities. Discussion: Although the PWG identified close agreement with RI diagnoses for most tumor types, it did not find close agreement for lymphoma/leukemia of the respiratory tract or for neoplasms of the inner ear and cranium. Here we discuss a) the implications of the PWG findings, particularly lymphoma diagnostic issues; b) differences between RI studies and those from other laboratories that are relevant to evaluating RI cancer bioassays; and c) future work that may help resolve some concerns. Conclusions: We concluded that a) issues related to respiratory tract infections have complicated diagnoses at that site (i.e., lymphoma/leukemia), as well as for neoplasms of the inner ear and cranium, and b) there is consistency and value in RI studies for identification of other chemical-related neoplasia. Citation: Gift JS, Caldwell JC, Jinot J, Evans MV, Cote I, Vandenberg JJ. 2013. Scientific considerations for evaluating cancer bioassays conducted by the Ramazzini Institute. Environ Health Perspect 121:1253–1263; http://dx.doi.org/10.1289/ehp.1306661 PMID:24045135

The SABRE Trial (Sirolimus Angioplasty Balloon for Coronary In-Stent Restenosis): Angiographic Results and 1-Year Clinical Outcomes.

PubMed

Verheye, Stefan; Vrolix, Mathias; Kumsars, Indulis; Erglis, Andrejs; Sondore, Dace; Agostoni, Pierfrancesco; Cornelis, Kristoff; Janssens, Luc; Maeng, Michael; Slagboom, Ton; Amoroso, Giovanni; Jensen, Lisette Okkels; Granada, Juan F; Stella, Pieter

2017-10-23

The aim of this first-in-human study was to assess the safety and effectiveness of the Virtue sirolimus-eluting balloon in a cohort of patients with in-stent restenosis (ISR). Angioplasty balloons coated with the cytotoxic drug paclitaxel have been widely used for ISR treatment. The Virtue angioplasty balloon (Caliber Therapeutics, New Hope, Pennsylvania) delivers sirolimus in a nanoencapsulated liquid formulation. This clinical trial is the first to examine a sirolimus-eluting balloon for ISR. In this prospective, single-arm feasibility study at 9 European centers, 50 ISR patients were treated with the Virtue balloon. Angiographic measurements at 6 months are reported, along with 12-month clinical follow-up. Procedural success in the intention-to-treat population was 100%. The primary safety endpoint was target lesion failure (TLF) (cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization) assessed at 30 days (0%, n = 50). The primary performance endpoint was in-segment late lumen loss (LLL) at 6 months (0.31 ± 0.52 mm; n = 47). Secondary 6-month endpoints include binary restenosis (19.1%), diameter stenosis (30.3 ± 19.9%), and major adverse cardiac events (MACE) (10.2%, n = 49). In the 36-patient per-protocol population (excluding major protocol violations and previously stented ISR), LLL was 0.12 ± 0.33 mm at 6 months. Clinical outcomes at 1 year for the intention-to-treat group were 12.2% TLF and 14.3% MACE and for the per-protocol population were 2.8% TLF and 2.8% MACE. This first-in-human study showed excellent procedural success for the Virtue sirolimus-eluting angioplasty balloon, 6-month LLL rates in line with current stent-free ISR treatment options, and clinical outcomes that warrant further evaluation in dedicated randomized studies. Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Visualisation and communication of probabilistic climate forecasts to renewable-energy policy makers

NASA Astrophysics Data System (ADS)

Steffen, Sophie; Lowe, Rachel; Davis, Melanie; Doblas-Reyes, Francisco J.; Rodó, Xavier

2014-05-01

Despite the strong dependence on weather and climate variability of the renewable-energy industry, and the existence of several initiatives towards demonstrating the added benefits of integrating probabilistic forecasts into energy decision-making processes, weather and climate forecasts are still under-utilised within the sector. Improved communication is fundamental to stimulate the use of climate forecast information within decision-making processes, in order to adapt to a highly climate dependent renewable-energy industry. This work focuses on improving the visualisation of climate forecast information, paying special attention to seasonal time scales. This activity is central to enhance climate services for renewable energy and to optimise the usefulness and usability of inherently complex climate information. In the realm of the Global Framework for Climate Services (GFCS) initiative, and subsequent European projects: Seasonal-to-Decadal Climate Prediction for the Improvement of European Climate Service (SPECS) and the European Provision of Regional Impacts Assessment in Seasonal and Decadal Timescales (EUPORIAS), this paper investigates the visualisation and communication of seasonal forecasts with regards to their usefulness and usability, to enable the development of a European climate service. The target end user is the group of renewable-energy policy makers, who are central to enhance climate services for the energy industry. The overall objective is to promote the wide-range dissemination and exchange of actionable climate information based on seasonal forecasts from Global Producing Centres (GPCs). It examines the existing main barriers and deficits. Examples of probabilistic climate forecasts from different GPC's are used to make a catalogue of current approaches, to assess their advantages and limitations and, finally, to recommend better alternatives. Interviews have been conducted with renewable-energy stakeholders to receive feedback for the improvement of existing visualisation techniques of forecasts. The overall aim is to establish a communication protocol for the visualisation of probabilistic climate forecasts, which does not currently exist. GPCs show their own probabilistic forecasts with limited consistency in their communication across different centres, which complicates the understanding for the end user. The recommended communication protocol for both the visualisation and description of climate forecasts can help to introduce a standard format and message to end users from several climate-sensitive sectors, such as energy, tourism, agriculture and health.

Implementation fidelity of Multidimensional Family Therapy in an international trial.

PubMed

Rowe, Cynthia; Rigter, Henk; Henderson, Craig; Gantner, Andreas; Mos, Kees; Nielsen, Philip; Phan, Olivier

2013-04-01

Implementation fidelity, a critical aspect of clinical trials research that establishes adequate delivery of the treatment as prescribed in treatment manuals and protocols, is also essential to the successful implementation of effective programs into new practice settings. Although infrequently studied in the drug abuse field, stronger implementation fidelity has been linked to better outcomes in practice but appears to be more difficult to achieve with greater distance from model developers. In the INternational CAnnabis Need for Treatment (INCANT) multi-national randomized clinical trial, investigators tested the effectiveness of Multidimensional Family Therapy (MDFT) in comparison to individual psychotherapy (IP) in Brussels, Berlin, Paris, The Hague, and Geneva with 450 adolescents with a cannabis use disorder and their parents. This study reports on the implementation fidelity of MDFT across these five Western European sites in terms of treatment adherence, dose and program differentiation, and discusses possible implications for international implementation efforts. Copyright © 2013 Elsevier Inc. All rights reserved.

Short-term culture of ovarian cortex pieces to assess the cryopreservation outcome in wild felids for genome conservation

PubMed Central

2013-01-01

Background Cryopreservation of ovarian tissue has the potential to preserve female germ cells of endangered mammals. In the present study, a freezing protocol successfully used for human tissue, was adapted for preserving ovarian tissue of domestic and non-domestic felids. Ovaries from non-domestic felid species were obtained from seven freshly euthanized and two recently deceased wild felids kept in different European Zoos. In addition, ovaries from domestic cats were obtained after ovariectomy from local veterinary clinics for methological adaptations. Ovarian cortex was dissected and uniform sized pieces of 2 mm diameter were obtained. Using a slow freezing protocol (-0.3°C per min) in 1.5 mol/L ethylene glycol, 0.1 mol/L sucrose, the pieces were cultured for up to 14 days both before and after cryopreservation. The integrity of primordial follicles was assessed by histology, and the impact of different protein sources (FCS or BSA) and Vitamin C was determined during two weeks of culture. Results and conclusion During culture the number of primordial follicles decreased within the ovarian pieces (p < 0.05). This effect was less pronounced when FCS was used as the protein source instead of BSA. Supplementation with Vitamin C had a detrimental effect on follicle survival. Since the procedure of cryopreservation had no effect on the follicle survival after one week of culture we conclude that the freezing protocol was suitable for felids. This is the first report of preserving a huge amount of follicles within ovarian tissue by slow freezing performed in several wild feline species. PMID:23433001

Ward safety perceived by ward managers in Britain, Germany and Switzerland: identifying factors that improve ability to deal with violence.

PubMed

Lepping, P; Steinert, T; Needham, I; Abderhalden, C; Flammer, E; Schmid, P

2009-09-01

Little is known about how safe nurses feel on psychiatric wards across different European countries. This paper is aim to evaluate how ward safety is perceived by ward managers in Great Britain, Germany and Switzerland. We replicated a Swiss questionnaire study in Germany and Britain, which asked ward managers on adult psychiatric wards to give details about their ward including data on the management of aggression, staffing levels, staff training, standards and type of restraint used, alarm devices, treatment and management of aggression and the existence and perceived efficacy of standards (protocols, guidelines). The British sample had by far the highest staffing levels per psychiatric bed, followed by Switzerland and Germany. The British ward managers by far perceived violence and aggression least as a problem on their wards, followed by Germany and then Switzerland. British ward managers are most satisfied with risk management and current practice dealing with violence. German managers were most likely to use fixation and most likely to have specific documentation for coercive measures. Swiss wards were most likely to use non-specific bedrooms for seclusion and carry alarm devices. British wards were far more likely to have protocols and training for the treatment and management of violence, followed by Switzerland and Germany. British ward managers by far perceived violence and aggression to be a small problem on their wards compared with Swiss and German ward managers. This was associated with the availability of control and restraint teams, regular training, clear protocols and a lesser degree risk assessments, but not staffing levels.

The resident microflora of voided midstream urine of healthy controls: standard versus expanded urine culture protocols.

PubMed

Coorevits, L; Heytens, S; Boelens, J; Claeys, G

2017-04-01

The workup and interpretation of urine cultures is not always clear-cut, especially for midstream samples contaminated with commensals. Standard urine culture (SUC) protocols are designed in favor of growth of uropathogens at the expense of commensals. In selected clinical situations, however, it is essential to trace fastidious or new uropathogens by expanding the urine culture conditions (EUC). The aim of our study was to map the microflora in midstream urine specimens from healthy controls by means of EUC, in view of the interpretation of bacterial culture results in symptomatic patients. Midstream urine specimens from 101 healthy controls (86 females and 15 males) were examined using both SUC and EUC. Whilst 73 % of samples examined by SUC showed no growth at 10 3  colony-forming units (CFU)/mL, 91 % of samples examined by EUC grew bacterial species in large numbers (≥10 4  CFU/mL). Asymptomatic bacteriuria, as defined by the European guidelines for urinalysis, was detected in six samples with both protocols. EUC revealed 98 different species, mostly Lactobacillus, Staphylococcus, Streptococcus, and Corynebacterium. None of the samples grew Staphylococcus saprophyticus, Corynebacterium urealyticum, or Aerococcus urinae. Samples from females contained higher bacterial loads and showed higher bacterial diversity compared to males. Midstream urine of healthy controls contains large communities of living bacteria that comprise a resident microflora, only revealed by EUC. Hence, the use of EUC instead of SUC in a routine setting would result in more sensitive but less specific results, requiring critical interpretation. In our view, EUC should be reserved for limited indications.

Identification of Challenges to the Availability and Accessibility of Opioids in Twelve European Countries: Conclusions from Two ATOME Six-Country Workshops.

PubMed

Linge-Dahl, Lisa; Vranken, Marjolein; Juenger, Saskia; North, Kate; Scholten, Willem; Payne, Sheila; Radbruch, Lukas

2015-12-01

Access to many controlled medicines is inadequate in a number of European countries. This leads to deficits in the treatment of moderate to severe pain as well as in opioid agonist therapy. The study objective was to elaborate the reasons for this inadequacy. The work plan of the Access to Opioid Medication in Europe (ATOME) project included two six-country workshops. These workshops comprised a national situational analysis, drafting tailor-made recommendations for improvement and developing action plans for their implementation. In total, 84 representatives of the national Ministries of Health, national controlled substances authorities, experts representing regulatory and law enforcement authorities, leading health care professionals, and patient representatives from 13 European countries participated in either one of the workshops. The delegates used breakout sessions to identify key common challenges. Content analysis was used for the evaluation of protocols and field notes. A number of challenges to opioid accessibility in the countries was identified in the domains of knowledge and educational, regulatory, legislative, as well as public awareness and training barriers that limit opioid prescription. In addition, short validity of prescriptions and bureaucratic practices resulting in overregulation impeded availability of some essential medicines. Stigmatization and criminalisation of people who use drugs remained the major impediment to increasing opioid agonist program coverage. The challenges identified during outcomes of the workshops were used as the basis for subsequent dissemination and implementation activities in the ATOME project, and in some countries the workshop proceedings already served as a stepping-stone for the first changes in regulations and legislation.

Clinical decision support systems in child and adolescent psychiatry: a systematic review.

PubMed

Koposov, Roman; Fossum, Sturla; Frodl, Thomas; Nytrø, Øystein; Leventhal, Bennett; Sourander, Andre; Quaglini, Silvana; Molteni, Massimo; de la Iglesia Vayá, María; Prokosch, Hans-Ulrich; Barbarini, Nicola; Milham, Michael Peter; Castellanos, Francisco Xavier; Skokauskas, Norbert

2017-11-01

Psychiatric disorders are amongst the most prevalent and impairing conditions in childhood and adolescence. Unfortunately, it is well known that general practitioners (GPs) and other frontline health providers (i.e., child protection workers, public health nurses, and pediatricians) are not adequately trained to address these ubiquitous problems (Braddick et al. Child and Adolescent mental health in Europe: infrastructures, policy and programmes, European Communities, 2009; Levav et al. Eur Child Adolesc Psychiatry 13:395-401, 2004). Advances in technology may offer a solution to this problem with clinical decision support systems (CDSS) that are designed to help professionals make sound clinical decisions in real time. This paper offers a systematic review of currently available CDSS for child and adolescent mental health disorders prepared according to the PRISMA-Protocols (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols). Applying strict eligibility criteria, the identified studies (n = 5048) were screened. Ten studies, describing eight original clinical decision support systems for child and adolescent psychiatric disorders, fulfilled inclusion criteria. Based on this systematic review, there appears to be a need for a new, readily available CDSS for child neuropsychiatric disorder which promotes evidence-based, best practices, while enabling consideration of national variation in practices by leveraging data-reuse to generate predictions regarding treatment outcome, addressing a broader cluster of clinical disorders, and targeting frontline practice environments.

Pediatric emergency care in europe: a descriptive survey of 53 tertiary medical centers.

PubMed

Mintegi, Santiago; Shavit, Itai; Benito, Javier

2008-06-01

To examine determinants of quality of care provided by pediatric emergency departments (PEDs) in tertiary European centers. Analysis of questionnaires was sent to directors of PEDs. Questionnaires were sent through the pediatric research group of the European Society for Emergency Medicine. Three major descriptive categories were included in a 28-point questionnaire: institution's pediatric inpatient capabilities, scope of services, and medical staff education and structure. Sixty-five questionnaires were completed in full. Fifty-three tertiary medical centers from 14 countries were included in the study. In 86.8% of these institutions, the PED is separated from the adult emergency department; 91% have a pediatric intensive care unit, and 72% have an in-patient pediatric trauma service. Eighty-eight percent of the PEDs have incorporated triage protocols. Social service was not available in 17% of the departments. Sedation for painful procedures is provided by the staff in 77% of the PEDs. Only 24% of the PED medical directors have been formally trained in pediatric emergency medicine. In 17% of the departments, there is a 24-hour 7-day residents' coverage with no attending pediatrician or pediatric emergency medicine-trained physician. According to this pilot study, the basic services provided by tertiary PEDs in Europe appear to be appropriate. Physicians training level and staffing may not be adequate to achieve optimal patient outcome.

Physical health problems among patients seeking treatment for alcohol use disorders: a study in six European cities.

PubMed

Gossop, Michael; Neto, Domingos; Radovanovic, Mirjana; Batra, Anil; Toteva, Sonya; Musalek, Michael; Skutle, Arvid; Goos, Cees

2007-06-01

The present study investigates physical health problems among patients with alcohol use disorders at alcohol treatment agencies in six European cities. The sample comprised 315 patients with a primary alcohol use disorder. Data were collected at admission to treatment using a structured research protocol, and ratings were made by a medically qualified physician subsequent to a physical examination of the patient. Physical health problems were extremely common: 79% of the sample had at least one problem, and 59% had two or more problems. Health problems were often serious, and 60% had at least one health problem that required treatment. The most common problems were gastrointestinal and liver disorders, but about a quarter of the sample had cardiovascular or neurological problems. Frequency of drinking, duration of alcohol use disorder, and severity of alcohol dependence were associated with increased physical morbidity. Current smoking status and age were also associated with poorer physical health. Older drinkers had more physical health problems although they were less severely alcohol dependent than their younger counterparts. The high prevalence of physical health problems among problem drinkers provides opportunities of screening for alcohol use disorders not only in specialist alcohol treatment services but also in other health-care settings. It is recommended that alcohol treatment agencies should provide a full routine health screen of patients at admission to treatment with provision or referral to appropriate treatment.

Frozen embryo transfer: a review on the optimal endometrial preparation and timing.

PubMed

Mackens, S; Santos-Ribeiro, S; van de Vijver, A; Racca, A; Van Landuyt, L; Tournaye, H; Blockeel, C

2017-11-01

What is the optimal endometrial preparation protocol for a frozen embryo transfer (FET)? Although the optimal endometrial preparation protocol for FET needs further research and is yet to be determined, we propose a standardized timing strategy based on the current available evidence which could assist in the harmonization and comparability of clinic practice and future trials. Amid a continuous increase in the number of FET cycles, determining the optimal endometrial preparation protocol has become paramount to maximize ART success. In current daily practice, different FET preparation methods and timing strategies are used. This is a review of the current literature on FET preparation methods, with special attention to the timing of the embryo transfer. Literature on the topic was retrieved in PubMed and references from relevant articles were investigated until June 2017. The number of high quality randomized controlled trials (RCTs) is scarce and, hence, the evidence for the best protocol for FET is poor. Future research should compare both the pregnancy and neonatal outcomes between HRT and true natural cycle (NC) FET. In terms of embryo transfer timing, we propose to start progesterone intake on the theoretical day of oocyte retrieval in HRT and to perform blastocyst transfer at hCG + 7 or LH + 6 in modified or true NC, respectively. As only a few high quality RCTs on the optimal preparation for FET are available in the existing literature, no definitive conclusion for benefit of one protocol over the other can be drawn so far. Caution when using HRT for FET is warranted since the rate of early pregnancy loss is alarmingly high in some reports. S.M. is funded by the Research Fund of Flanders (FWO). H.T. and C.B. report grants from Merck, Goodlife, Besins and Abbott during the conduct of the study. Not applicable. © The Author 2017. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com

Using EMBL-EBI services via Web interface and programmatically via Web Services

PubMed Central

Lopez, Rodrigo; Cowley, Andrew; Li, Weizhong; McWilliam, Hamish

2015-01-01

The European Bioinformatics Institute (EMBL-EBI) provides access to a wide range of databases and analysis tools that are of key importance in bioinformatics. As well as providing Web interfaces to these resources, Web Services are available using SOAP and REST protocols that enable programmatic access to our resources and allow their integration into other applications and analytical workflows. This unit describes the various options available to a typical researcher or bioinformatician who wishes to use our resources via Web interface or programmatically via a range of programming languages. PMID:25501941

Establishment of heart teams in Portugal.

PubMed

Sousa Uva, M; Leite Moreira, A; Gavina, C; Pereira, H; Lopes, M G

2014-01-01

Whenever several therapeutic options exist, multidisciplinary decision-making is beneficial for the patient and for society at large. The main obstacles to the establishment of heart teams in Portugal are organizational and logistical. Implementing a heart team approach entails definition of the situations requiring multidisciplinary discussion, creation of clear lines of communication, written protocols and obtaining patient informed consent. The European Society of Cardiology guidelines define the clinical scenarios where intervention of the heart team is recommended. Copyright © 2013 Sociedade Portuguesa de Cardiologia. Published by Elsevier España. All rights reserved.

Conference Scene: novelties in immunotherapy.

PubMed

Mitsias, Dimitris I; Kalogiros, Lampros A; Papadopoulos, Nikolaos G

2013-10-01

The only method aiming to permanently cure allergic disorders is allergen immunotherapy. Over the last 20 years there has been great progress in understanding the mechanisms that govern allergen immunotherapy in order to meet three basic prerequisites: safety, effectiveness and compliance. In the present summary report from the European Academy of Allergology and Clinical Immunology-World Allergy Organization Congress held last June in Milan, we review key points concerning the main axes as diagnosis, novel modalities, routes and protocols, as well as two important immunotherapy fields: food and insect venom allergy.

Effects of virtual rehabilitation versus conventional physical therapy on postural control, gait, and cognition of patients with Parkinson's disease: study protocol for a randomized controlled feasibility trial.

PubMed

Silva, Keyte Guedes; De Freitas, Tatiana Beline; Doná, Flávia; Ganança, Fernando Freitas; Ferraz, Henrique Ballalai; Torriani-Pasin, Camila; Pompeu, José Eduardo

2017-01-01

There is an association among postural instability, gait dysfunction, and cognitive impairment in subjects with Parkinson's disease (PD). Difficulty in dividing attention, response inhibition, and visuospatial attention deficiencies may contribute to the impairment of motor performance during daily activities. There are strong evidences that physical therapy can prevent physical and cognitive decline in individuals with PD. Recently, the European Physiotherapy Guideline (EPG) was developed based on randomized clinical trials about the effectiveness of the physical therapy to improve the functional deficiencies of individuals with PD. The EPG did not include the use of promising new intervention as virtual reality in PD due the lack of studies about its safety, feasibility and effectiveness. Therefore, this study protocol had as objective to evaluate the feasibility, safety and effectiveness of a physical therapy program-based on the European Physiotherapy Guideline (EPG) compared to Kinect-based training on postural control, gait, cognition, and quality of life (QoL) of Individuals with PD. A single-blind, parallel, randomized, controlled feasibility trial will be conducted with a sample of 32 individuals diagnosed with idiopathic PD. Participants will be allocated into control group (CG) and experimental group (EG). The intervention of the CG will be conventional physical therapy, and the intervention of the EG will be a supervised practice of five Kinect games. Both groups will perform 14 sessions of 1 h each one, twice a week over 7 weeks. Process outcomes will be safety, feasibility, adherence, and acceptability. Safety will be assessed by the proportion of participants who experienced intervention-related adverse events or any serious adverse event during the study period. Feasibility will be assessed through the scores of the games recorded in all training sessions. Adherence will be assessed through the participant's attendance. Acceptability will be the motivation of the participants regarding the interventions. Clinical outcomes will be (1) postural control, (2) cognitive function, (3) balance, (4) gait, and (5) QoL. Individuals will be assessed pre- and post-interventions and after 30 days by a blinded evaluator. This protocol will clarify if an intervention based on Kinect games will be feasible, safe, and acceptable for individuals with PD compared to conventional physical therapy. We will verify whether the proposed interventions can improve clinical outcomes as postural control, gait, cognition, and QoL of individuals with PD. Our hypothesis is that both Kinect games and conventional physical therapy will be feasible, safe, and acceptable for individuals with PD and will promote positive clinical effects. The results of this feasibility study will be used to design a future definitive clinical trial. Unique identification number in WHO Trial Registration: U1111-1171-0371. Brazilian Clinical Trial Registration Number RBR-27kqv5, registration date: February, 2016.

The implementation of European Association of Urology guidelines in the management of acute epididymo-orchitis.

PubMed

Garthwaite, Mary A E; Johnson, G; Lloyd, S; Eardley, I

2007-11-01

Acute epididymo-orchitis is a common and increasing problem. This retrospective study reviewed whether the European Association of Urology guidelines for the management of acute epididymo-orchitis, which form the basis of this Trust's present inter-departmental guidelines, are being effectively implemented. Case notes of 53 patients attending the emergency department with acute epididymo-orchitis over a 6-month period were reviewed retrospectively. The hospital results' database was used to confirm the diagnostic tests requested on patients at the time of their initial presentation. Of the study cohort, 26 patients were aged 35 years. The results demonstrated that a sexual history was documented in only 43.4% of cases. A mid-stream urine sample was sent for routine culture in 54.7% of cases whilst urine for the Chlamydia polymerase chain reaction (PCR) test was obtained in 17% and a urethral swab performed in 5.6%. Antibiotics were prescribed in 81% of cases. Of these patients, 46.5% received ciprofloxacin alone (mean age, 52 years; range, 18-87 years), 25.5% received doxycycline alone (mean age, 30 years; range, 18-45 years) and 21% received both ciprofloxacin and doxycycline (mean age, 33 years; range 18-49 years). In 26.4% of cases, verbal advice to attend a genito-urinary medicine clinic was given, whilst a formal telephone referral was made in only one case. Formal urological follow-up was arranged for only three out of 11 patients aged > 50 years. Although a joint emergency department/urology clinical protocol for the investigation and treatment of acute epididymo-orchitis already exists within the Trust, our current management conforms to this in only a minority of cases. Many different strategies can be employed in the implementation of clinical practice guidelines and all are associated with variable degrees of success. The regular movement of junior staff through each department necessitates that the distribution of management protocols and guidelines occurs at frequent intervals throughout the year and that their implementation is continuously monitored so that, if necessary, further implementation strategies can be employed.

Household preferences for reducing greenhouse gas emissions in four European high-income countries: Does health information matter? A mixed-methods study protocol.

PubMed

Herrmann, Alina; Fischer, Helen; Amelung, Dorothee; Litvine, Dorian; Aall, Carlo; Andersson, Camilla; Baltruszewicz, Marta; Barbier, Carine; Bruyère, Sébastien; Bénévise, Françoise; Dubois, Ghislain; Louis, Valérie R; Nilsson, Maria; Richardsen Moberg, Karen; Sköld, Bore; Sauerborn, Rainer

2017-08-01

It is now universally acknowledged that climate change constitutes a major threat to human health. At the same time, some of the measures to reduce greenhouse gas emissions, so-called climate change mitigation measures, have significant health co-benefits (e.g., walking or cycling more; eating less meat). The goal of limiting global warming to 1,5° Celsius set by the Conference of the Parties to the United Nations Framework Convention on Climate Change in Paris in 2015 can only be reached if all stakeholders, including households, take actions to mitigate climate change. Results on whether framing mitigation measures in terms of their health co-benefits increases the likelihood of their implementation are inconsistent. The present study protocol describes the transdisciplinary project HOPE (HOuseholds' Preferences for reducing greenhouse gas emissions in four European high-income countries) that investigates the role of health co-benefits in households' decision making on climate change mitigation measures in urban households in France, Germany, Norway and Sweden. HOPE employs a mixed-methods approach combining status-quo carbon footprint assessments, simulations of the reduction of households' carbon footprints, and qualitative in-depth interviews with a subgroup of households. Furthermore, a policy analysis of current household oriented climate policies is conducted. In the simulation of the reduction of households' carbon footprints, half of the households are provided with information on health co-benefits of climate change mitigation measures, the other half is not. Households' willingness to implement the measures is assessed and compared in between-group analyses of variance. This is one of the first comprehensive mixed-methods approaches to investigate which mitigation measures households are most willing to implement in order to reach the 1,5° target set by the Paris Agreement, and whether health co-benefits can serve as a motivator for households to implement these measures. The comparison of the empirical data with current climate policies will provide knowledge for tailoring effective climate change mitigation and health policies.

Exposure to hot and cold environmental conditions does not affect the decision making ability of soccer referees following an intermittent sprint protocol.

PubMed

Taylor, Lee; Fitch, Natalie; Castle, Paul; Watkins, Samuel; Aldous, Jeffrey; Sculthorpe, Nicholas; Midgely, Adrian; Brewer, John; Mauger, Alexis

2014-01-01

Soccer referees enforce the laws of the game and the decisions they make can directly affect match results. Fixtures within European competitions take place in climatic conditions that are often challenging (e.g., Moscow ~ -5°C, Madrid ~30°C). Effects of these temperatures on player performance are well-documented; however, little is known how this environmental stress may impair cognitive performance of soccer referees and if so, whether exercise exasperates this. The present study aims to investigate the effect of cold [COLD; -5°C, 40% relative humidity (RH)], hot (HOT; 30°C, 40% RH) and temperate (CONT; 18°C, 40% RH) conditions on decision making during soccer specific exercise. On separate occasions within each condition, 13 physically active males; either semi-professional referees or semi-professional soccer players completed three 90 min intermittent treadmill protocols that simulated match play, interspersed with 4 computer delivered cognitive tests to measure vigilance and dual task capacity. Core and skin temperature, heart rate, rating of perceived exertion (RPE) and thermal sensation (TS) were recorded throughout the protocol. There was no significant difference between conditions for decision making in either the dual task (interaction effects: FALSE p = 0.46; MISSED p = 0.72; TRACKING p = 0.22) or vigilance assessments (interaction effects: FALSE p = 0.31; HIT p = 0.15; MISSED p = 0.17) despite significant differences in measured physiological variables (skin temperature: HOT vs. CONT 95% CI = 2.6 to 3.9, p < 0.001; HOT vs. COLD 95% CI = 6.6 to 9.0, p < 0.001; CONT vs. COLD 95% CI = 3.4 to 5.7, p < 0.01). It is hypothesized that the lack of difference observed in decision making ability between conditions was due to the exercise protocol used, as it may not have elicited an appropriate and valid soccer specific internal load to alter cognitive functioning.

Comparison of three blood transfusion guidelines applied to 31 feline donors to minimise the risk of transfusion-transmissible infections.

PubMed

Marenzoni, Maria Luisa; Lauzi, Stefania; Miglio, Arianna; Coletti, Mauro; Arbia, Andrea; Paltrinieri, Saverio; Antognoni, Maria Teresa

2017-08-01

Objectives The increased demand for animal blood transfusions creates the need for an adequate number of donors. At the same time, a high level of blood safety must be guaranteed and different guidelines (GLs) deal with this topic. The aim of this study was to evaluate the appropriateness of different GLs in preventing transfusion-transmissible infections (TTI) in Italian feline blood donors. Methods Blood samples were collected from 31 cats enrolled as blood donors by the owners' voluntary choice over a period of approximately 1 year. Possible risk factors for TTI were recorded. Based on Italian, European and American GLs, specific TTI, including haemoplasmas, feline leukaemia virus (FeLV), feline immunodeficiency virus (FIV), Anaplasma phagocytophilum, Ehrlichia species, Bartonella species, Babesia species, Theileria species, Cytauxzoon species, Leishmania donovani sensu lato and feline coronavirus (FCoV) were screened. Rapid antigen and serological tests and biomolecular investigations (PCR) were used. Several PCR protocols for haemoplasma and FeLV DNA were compared. Results The presence of at least one recognised risk factor for TTI was reported in all cats. Results for FIV and FeLV infections were negative using rapid tests, whereas five (16.1%) cats were positive for FCoV antibodies. Four (12.9%) cats were PCR positive for haemoplasma DNA and one (3.2%) for FeLV provirus, the latter being positive only using the most sensitive PCR protocol applied. Other TTI were not detected using PCR. Conclusions and relevance Blood safety increases by combining the recommendations of different GLs. To reduce the risk of TTI, sensitive tests are needed and the choice of the best protocol is a critical step in improving blood safety. The cost and time of the screening procedures may be reduced if appropriate tests are selected. To this end, the GLs should include appropriate recruitment protocols and questionnaire-based risk profiles to identify suitable donors.

15 years of monitoring occupational exposure to respirable dust and quartz within the European industrial minerals sector.

PubMed

Zilaout, Hicham; Vlaanderen, Jelle; Houba, Remko; Kromhout, Hans

2017-07-01

In 2000, a prospective Dust Monitoring Program (DMP) was started in which measurements of worker's exposure to respirable dust and quartz are collected in member companies from the European Industrial Minerals Association (IMA-Europe). After 15 years, the resulting IMA-DMP database allows a detailed overview of exposure levels of respirable dust and quartz over time within this industrial sector. Our aim is to describe the IMA-DMP and the current state of the corresponding database which due to continuation of the IMA-DMP is still growing. The future use of the database will also be highlighted including its utility for the industrial minerals producing sector. Exposure data are being obtained following a common protocol including a standardized sampling strategy, standardized sampling and analytical methods and a data management system. Following strict quality control procedures, exposure data are consequently added to a central database. The data comprises personal exposure measurements including auxiliary information on work and other conditions during sampling. Currently, the IMA-DMP database consists of almost 28,000 personal measurements which have been performed from 2000 until 2015 representing 29 half-yearly sampling campaigns. The exposure data have been collected from 160 different worksites owned by 35 industrial mineral companies and comes from 23 European countries and approximately 5000 workers. The IMA-DMP database provides the European minerals sector with reliable data regarding worker personal exposures to respirable dust and quartz. The database can be used as a powerful tool to address outstanding scientific issues on long-term exposure trends and exposure variability, and importantly, as a surveillance tool to evaluate exposure control measures. The database will be valuable for future epidemiological studies on respiratory health effects and will allow for estimation of quantitative exposure response relationships. Copyright © 2017 The Authors. Published by Elsevier GmbH.. All rights reserved.

Hot heads & cool bodies: The conundrums of human brown adipose tissue (BAT) activity research.

PubMed

Bahler, Lonneke; Holleman, Frits; Booij, Jan; Hoekstra, Joost B; Verberne, Hein J

2017-05-01

Brown adipose tissue is able to increase energy expenditure by converting glucose and fatty acids into heat. Therefore, BAT is able to increase energy expenditure and could thereby facilitate weight loss or at least weight maintenance. Since cold is a strong activator of BAT, most prospective research is performed during cold to activate BAT. In current research, there are roughly two methods of cooling. Cooling by lowering ambient air temperature, which uses a fixed temperature for all subjects and personalized cooling, which uses cooling blankets or vests with temperatures that can be adjusted to the individual set point of shivering. These methods might trigger mechanistically different cold responses and hence result in a different BAT activation. This hypothesis is underlined by two studies with the same research question (difference in BAT activity between Caucasians and South Asians) one study found no differences in BAT activity whereas the other did found differences in BAT activity. Since most characteristics (e.g. age, BMI) were similar in the two studies, the best explanation for the differences in outcomes is the use of different cooling protocols. One of the reasons for differences in outcomes might be the sensory input from the facial skin, which might be important for the activation of BAT. In this review we will elaborate on the differences between the two cooling protocols used to activate BAT. Copyright © 2017 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.

A Youth-Led, Social Marketing Intervention Run by Adolescents to Encourage Healthy Lifestyles among Younger School Peers (EYTO-Kids Project): A Protocol for Pilot Cluster Randomized Controlled Trial (Spain)

PubMed Central

Aceves-Martins, Magaly; Papell-Garcia, Ignasi; Arola, Lluís; Giralt, Montse; Solà, Rosa

2017-01-01

Introduction: The EYTO-kids (European Youth Tackling Obesity in Adolescents and Children) study aims to increase fruit and/or vegetable consumption and physical activity, decrease sedentary lifestyles, and reduce the intake of sugary drinks and fast food using an innovative methodology based on social marketing and youth involvement. Methods: This study is a pilot school-based cluster randomized controlled 10-month intervention spanning two academic years (2015–2016 and 2016–2017), with eight primary schools and three high schools randomized into and designated the control group and eight primary schools and four high schools designated the intervention group in Reus, Spain. At least 301 younger school peers per group should be included. At the intervention high schools, the adolescent creators (ACs) receive an initial 16-h training session. In total, 26–32 high school ACs (12–14 years) from the four high schools will design and implement four health-promotion activities (1 h/each) for their younger (8–10 years), primary school peers. The control group will not receive any intervention. The outcomes (fruit, vegetable, fast food and sugary drink consumption; physical activity; and sedentary behaviors) of the control and intervention groups will be measured pre- and post-intervention. Conclusion: This study describes a protocol for pilot, peer-led, social marketing and youth-involved intervention, where adolescents design and implement activities for their younger peers to promote healthy lifestyles.

A collaborative approach to investigating the risk of thrombocytopenic purpura after measles-mumps-rubella vaccination in England and Denmark.

PubMed

Andrews, Nick; Stowe, Julia; Miller, Elizabeth; Svanström, Henrik; Johansen, Kari; Bonhoeffer, Jan; Hviid, Anders

2012-04-19

The assessment of rare adverse events following vaccination may not be possible within a single country due to an insufficiently large denominator population. In 2008 a European consortium (VAESCO) was funded to perform collaborative vaccine safety studies. To help assess the feasibility of multi-country collaboration England and Denmark, who have established vaccine safety research infrastructures, undertook to work to a common protocol and share results and data to estimate the risk of a known true adverse event, thrombocytopenic purpura (TP) following measles-mumps-rubella (MMR) vaccination. TP is a known rare reaction to MMR and therefore provided an opportunity to assess whether two countries would produce similar results when working collaboratively. Despite some initial problems with ensuring data were comparable, the two countries gave very similar estimates of the relative incidence in the 6 weeks after vaccination and a pooled relative incidence estimate of 2.13 (95% confidence interval 1.55-2.94) and attributable risk of 1 in 50,000 doses. Both countries used hospital admissions for TP and the analysis was performed using the self controlled case series method which is particularly suited to collaborative studies because of its implicit control for individual level confounding. The study therefore shows the potential for vaccine safety collaborations across Europe to detect true associations through use of common protocols and sharing of results or data. Copyright © 2011 Brighton Collaboration. Published by Elsevier Ltd.. All rights reserved.

In search of acceptable alternatives to the murine histamine sensitisation test (HIST): what is possible and practical?

PubMed

Wagner, L; Isbrucker, R; Locht, C; Arciniega, J; Costanzo, A; McFarland, R; Oh, H; Hoonakker, M; Descamps, J; Andersen, S R; Gupta, R K; Markey, K; Chapsal, J M; Lidster, K; Casey, W; Allen, D

2016-01-01

The 'International Workshop on Alternatives to the Murine Histamine Sensitization Test for Acellular Pertussis Vaccines: In Search of Acceptable Alternatives to the Murine Histamine Sensitization Test (HIST): What is Possible and Practical?' was held on 4 and 5 March 2015 in London, United Kingdom. Participants discussed the results of the data generated from an international collaborative study (BSP114 Phase 2) sponsored by the European Directorate for the Quality of Medicines & Health Care (EDQM) to determine if a modified Chinese hamster ovary (CHO) cell-based clustering assay is a suitable alternative to replace HIST. Workshop participants agreed that protocol transferability demonstrated in the collaborative study indicates that a standardised CHO cell assay is adequate for measuring pure PTx in reference preparations. However, vaccine manufacturers would still need to demonstrate that the method is valid to detect or measure residual PTx in their specific adjuvanted products. The 2 modified CHO cell protocols included in the study (the Direct and the Indirect Methods) deserve further consideration as alternatives to HIST. Using the CHO cell assay, an in vitro alternative, for acellular pertussis (aP) vaccine batch release testing would reduce the number of animals used for aP vaccine safety testing. A strategic, stepwise adoption plan was proposed, in which the alternative test would be used for release purposes first, and then, once sufficient confidence in its suitable performance has been gained, its use would be extended to stability testing.

Development of a calibration protocol for quantitative imaging for molecular radiotherapy dosimetry

NASA Astrophysics Data System (ADS)

Wevrett, J.; Fenwick, A.; Scuffham, J.; Nisbet, A.

2017-11-01

Within the field of molecular radiotherapy, there is a significant need for standardisation in dosimetry, in both quantitative imaging and dosimetry calculations. Currently, there are a wide range of techniques used by different clinical centres and as a result there is no means to compare patient doses between centres. To help address this need, a 3 year project was funded by the European Metrology Research Programme, and a number of clinical centres were involved in the project. One of the required outcomes of the project was to develop a calibration protocol for three dimensional quantitative imaging of volumes of interest. Two radionuclides were selected as being of particular interest: iodine-131 (131I, used to treat thyroid disorders) and lutetium-177 (177Lu, used to treat neuroendocrine tumours). A small volume of activity within a scatter medium (water), representing a lesion within a patient body, was chosen as the calibration method. To ensure ease of use in clinical centres, an "off-the-shelf" solution was proposed - to avoid the need for in-house manufacturing. The BIODEX elliptical Jaszczak phantom and 16 ml fillable sphere were selected. The protocol was developed for use on SPECT/CT gamma cameras only, where the CT dataset would be used to correct the imaging data for attenuation of the emitted photons within the phantom. The protocol corrects for scatter of emitted photons using the triple energy window correction technique utilised by most clinical systems. A number of clinical systems were tested in the development of this protocol, covering the major manufacturers of gamma camera generally used in Europe. Initial imaging was performed with 131I and 177Lu at a number of clinical centres, but due to time constraints in the project, some acquisitions were performed with 177Lu only. The protocol is relatively simplistic, and does not account for the effects of dead-time in high activity patients, the presence of background activity surrounding volumes of interest or the partial volume effect of imaging lesions smaller than 16 ml. The development of this simple protocol demonstrates that it is possible to produce a standardised quantitative imaging protocol for molecular radiotherapy dosimetry. However, the protocol needs further development to expand it to incorporate other radionuclides, and to account for the effects that have been disregarded in this initial version.

Indoor air pollution on nurseries and primary schools: impact on childhood asthma--study protocol.

PubMed

Sousa, Sofia I V; Ferraz, Catarina; Alvim-Ferraz, Maria C M; Vaz, Luisa G; Marques, Agostinho J; Martins, Fernando G

2012-06-13

Several studies have demonstrated an association between the exposure to indoor air pollution (IAP) and childhood asthma. Evidence is suggesting that several air pollutants may contribute to both exacerbation and development of asthma, but some uncertainty remains concerning the specific causative role of IAP. This paper reports an epidemiologic study aiming to reduce the existing lacks on the association between long-term exposure to pollution mixtures and the development and exacerbation of childhood asthma. Based on the implementation of the study in 8 nurseries and 8 primary schools, from which, 2 nurseries and 2 primary schools in sites influenced by traffic and other 2 nurseries and 2 primary schools in background sites at urban and rural areas, the study will analyse the exposure to both urban and rural pollution as well as to traffic emissions (some homes of the children will be included in the study). Furthermore, based on the answers to validated questionnaires (as those used in the International Study of Asthma and Allergies in Childhood - ISAAC) filled in by the parents and on medical exams, the study will assess the prevalence, incidence and exacerbation of asthma, thus considering both short and long-term effects. The approximate number of children in the study will never be less than 600, guaranteeing 80% of study power (significant at a 5% level). This study intends to contribute for the understanding of the role of environmental factors, namely indoor air pollution, on asthma considering a risk group of different ages, and for the development of preventive measures, which are considered priority issues by the European Commission, according to the European Environmental Agency and the World Health Organization.

The UK's Draft Guidance for Health in SEA in light of HIA community priorities and the UNECE SEA Protocol

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

Posas, Paula J., E-mail: pjposas@gmail.co

2011-04-15

The Protocol on Strategic Environmental Assessment (SEA) to the United Nations Economic Commission for Europe (UNECE) Espoo Convention came into force on 11 July 2010. This Protocol, to which the European Union is party, gives a legal basis for enhanced attention to human health in the SEA process. In this context, the United Kingdom's (UK's) 2007 Draft Guidance on Health in Strategic Environmental Assessment represents an important early government-led effort to bring health issues and public health considerations more significantly into the SEA process. Since the UK is a worldwide leader in environmental and various other types of impact assessment,more » and since other countries may eventually consider its example in efforts to meet UNECE SEA Protocol requirements, scrutiny of its outputs is warranted. This paper thus examines the UK's Draft Guidance from both HIA academic and practitioner perspectives. First it assesses the extent to which the Draft Guidance reflects recent issues and lessons learned in the academic literature. In order to make the assessment, a meta-analysis of 70 HIA-related peer-reviewed articles was undertaken to extract authors' priority recommendations. These recommendations were subsequently compared with the contents of the Draft Guidance. Secondly, the Draft Guidance was assessed for its accordance with recommendations of the UNECE SEA Protocol background paper written by two HIA practitioners. Overall, the Draft Guidance's accordance with both sets of recommendations was found to be high, with only a few easily-remedied gaps. This evaluation suggests that the UK's Draft Guidance can be a useful starting point in the creation of future guidance on health in SEA in both the UK and other countries.« less

European survey on ethical and legal framework of clinical trials in paediatrics: results and perspectives.

PubMed

Altavilla, Annagrazia; Giaquinto, Carlo; Ceci, Adriana

2008-09-01

This article constitutes a synthesis and analysis of the results of the "Survey on the ethical and legal frameworks existing in Europe for paediatric clinical trials" carried out by the European network TEDDY. TEDDY is a "Network of Excellence" funded by the Sixth EU Framework Programme (FP6). It began its activities in June 2005 and it is scheduled to run until 2010. It involves 19 partners in 11 countries. The overall goal of TEDDY is to promote the availability of safe and effective medicines to children in Europe by integrating existing expertise and the good practices. In the domain of ethics, the main aim of TEDDY is raise the awareness of the public and researchers concerning issues linked to biomedical research in paediatrics, by contributing to developing the debate on the ethical and legal stakes, as well as the potential deviations, in order to ensure the best possible protection of children participating in clinical trials. This study, with twenty-seven participating countries (23 EU Member States and 4 countries associated to the Fifth and Sixth EU Framework Programme), proposes to highlight the existing differences in the legislation of European countries concerning the procedure of consent, as well as the guarantee of the paediatric expertise within the Ethics Committees which are in charge of evaluating research protocols. The study shows that, even though the Directive 2001/20/EC has been transposed, the value attributed to the consent of minors who participate in clinical trials is different depending on the European state. Despite the general rule of having the written consent of the legal representative of the minor, over a certain age (different in relation to each state) and under certain conditions, to give the consent alone to participate in biomedical research. Furthermore, there is an Ethics Committee for minors in only four countries. In addition, we illustrate the lack of information and in-depth debate in Europe concerning the ethical stakes of clinical trials in paediatrics. An overview of possible legal deviations is also presented.

Pediatric and Adolescent Gynecology in Europe: Clinical Services, Standards of Care, and Training.

PubMed

Richmond, Anna; Priyanka, Sweta; Mahmood, Tahir; MacDougall, Jane; Wood, Paul

2016-06-01

To identify current clinical services and training available across Europe within pediatric and adolescent gynecology (PAG) and establish the extent to which PAG services meet current European Board and College of Obstetrics and Gynecology (EBCOG) standards. Quantitative and qualitative questionnaire. European countries that are members of the EBCOG and the European Association of Pediatric and Adolescent Gynecology. Thirty-six countries that were approached beginning in September 2013; data were obtained from 27 countries. Questionnaires with 28 stems were sent to clinical leaders in 36 European countries. National society, national standards, legislation for female genital mutilation, protocols for transition to adult services, human papilloma virus vaccination programs, sex and contraception education, safeguarding, clinical leads for PAG, delivery of PAG services, and training available for PAG. Of 36 countries, 27 responded. Seventy-seven percent had a national PAG society but only 44% had national standards in PAG. There was agreement that PAG cases should be multidisciplinary but not all have clinical networks in place to facilitate this. Human papilloma virus programs are available in some European countries and not all have legislation against female genital mutilation. A significant proportion of cases continue to be seen in adult gynecology clinics as opposed to designated PAG clinics with only 41% with processes to transfer patients into adult care. In this article we provide a framework to explore areas for improvement within PAG services and training across Europe. The EBCOG standards of care are not being adhered to in many countries because processes and clinical networks are not in place to facilitate them. Crown Copyright © 2015. Published by Elsevier Inc. All rights reserved.

EuropeaN Energy balance Research to prevent excessive weight Gain among Youth (ENERGY) project: Design and methodology of the ENERGY cross-sectional survey.

PubMed

van Stralen, Maartje M; te Velde, Saskia J; Singh, Amika S; De Bourdeaudhuij, Ilse; Martens, Marloes K; van der Sluis, Maria; Manios, Yannis; Grammatikaki, Evangelia; Chinapaw, Mai J M; Maes, Lea; Bere, Elling; Jensen, Jorgen; Moreno, Luis; Jan, Nataša; Molnár, Dénes; Moore, Helen; Brug, Johannes

2011-01-31

Obesity treatment is by large ineffective long term, and more emphasis on the prevention of excessive weight gain in childhood and adolescence is warranted. To inform energy balance related behaviour (EBRB) change interventions, insight in the potential personal, family and school environmental correlates of these behaviours is needed. Studies on such multilevel correlates of EBRB among schoolchildren in Europe are lacking. The ENERGY survey aims to (1) provide up-to-date prevalence rates of measured overweight, obesity, self-reported engagement in EBRBs, and objective accelerometer-based assessment of physical activity and sedentary behaviour and blood-sample biomarkers of metabolic function in countries in different regions of Europe, (2) to identify personal, family and school environmental correlates of these EBRBs. This paper describes the design, methodology and protocol of the survey. A school-based cross-sectional survey was carried out in 2010 in seven different European countries; Belgium, Greece, Hungary, the Netherlands, Norway, Slovenia, and Spain. The survey included measurements of anthropometrics, child, parent and school-staff questionnaires, and school observations to measure and assess outcomes (i.e. height, weight, and waist circumference), EBRBs and potential personal, family and school environmental correlates of these behaviours including the social-cultural, physical, political, and economic environmental factors. In addition, a selection of countries conducted accelerometer measurements to objectively assess physical activity and sedentary behaviour, and collected blood samples to assess several biomarkers of metabolic function. The ENERGY survey is a comprehensive cross-sectional study measuring anthropometrics and biomarkers as well as assessing a range of EBRBs and their potential correlates at the personal, family and school level, among 10-12 year old children in seven European countries. This study will result in a unique dataset, enabling cross country comparisons in overweight, obesity, risk behaviours for these conditions as well as the correlates of engagement in these risk behaviours.

Physical Activity through Sustainable Transport Approaches (PASTA): a study protocol for a multicentre project

PubMed Central

de Nazelle, Audrey; Nieuwenhuijsen, Mark; Panis, Luc Int; Anaya, Esther; Avila-Palencia, Ione; Boschetti, Florinda; Brand, Christian; Cole-Hunter, Tom; Dons, Evi; Eriksson, Ulf; Gaupp-Berghausen, Mailin; Kahlmeier, Sonja; Laeremans, Michelle; Mueller, Natalie; Orjuela, Juan Pablo; Racioppi, Francesca; Raser, Elisabeth; Rojas-Rueda, David; Schweizer, Christian; Standaert, Arnout; Uhlmann, Tina; Wegener, Sandra; Götschi, Thomas

2016-01-01

Introduction Only one-third of the European population meets the minimum recommended levels of physical activity (PA). Physical inactivity is a major risk factor for non-communicable diseases. Walking and cycling for transport (active mobility, AM) are well suited to provide regular PA. The European research project Physical Activity through Sustainable Transport Approaches (PASTA) pursues the following aims: (1) to investigate correlates and interrelations of AM, PA, air pollution and crash risk; (2) to evaluate the effectiveness of selected interventions to promote AM; (3) to improve health impact assessment (HIA) of AM; (4) to foster the exchange between the disciplines of public health and transport planning, and between research and practice. Methods and analysis PASTA pursues a mixed-method and multilevel approach that is consistently applied in seven case study cities. Determinants of AM and the evaluation of measures to increase AM are investigated through a large scale longitudinal survey, with overall 14 000 respondents participating in Antwerp, Barcelona, London, Örebro, Rome, Vienna and Zurich. Contextual factors are systematically gathered in each city. PASTA generates empirical findings to improve HIA for AM, for example, with estimates of crash risks, factors on AM-PA substitution and carbon emissions savings from mode shifts. Findings from PASTA will inform WHO's online Health Economic Assessment Tool on the health benefits from cycling and/or walking. The study's wide scope, the combination of qualitative and quantitative methods and health and transport methods, the innovative survey design, the general and city-specific analyses, and the transdisciplinary composition of the consortium and the wider network of partners promise highly relevant insights for research and practice. Ethics and dissemination Ethics approval has been obtained by the local ethics committees in the countries where the work is being conducted, and sent to the European Commission before the start of the survey. The PASTA website (http://www.pastaproject.eu) is at the core of all communication and dissemination activities. PMID:26743706

Dolni Vestonice (Czech Republic) an intermédiate loess series between Western and eastern European records

NASA Astrophysics Data System (ADS)

Rousseau, D.; Antoine, P.; Hatte, C.; Lagroix, F.; Fuchs, M.; Moine, O.; Gauthier, C.; Svoboda, J.; Lisa, L.

2010-12-01

Previous investigations on western and eastern European loess series have shown similarities at least for the main loess deposition during the last climate cycle, recording North-Atlantic abrupt climate changes, the Dansgaard-Oeschger and Heinrich events. To address the question of how such record occurred through modeling experiments (Sima et al., QSR, 2009), we need reference series located in an intermediary position between the Nussloch (Germany - Antoine et al, QI 2001, QSR, 2009; Rousseau et al, GRL 2007) and Stayky (Ukraine -Rousseau et al, Clim Past D 2010) loess series at about 50°N latitude, location of the main deposits. The key sequence of Dolni Vestonice in southern Czech Republic, had been investigated previously and described by many authors since 1961, and more especially by G Kukla and B Klima. Here we present the preliminary results of the new study of this key sequence by a multidisciplinary study, supported by ANR-ACTES project, combining the detailed stratigraphy, AMS 14C and IRSL dating, rock magnetic property, grain size, d13C and mollusks analyses. We applied the same sampling protocol than previously developed, by carefully cleaning the sequence on a vertical panel, 15m high and 5m wide in order to have parallel samples (on continuous columns) easily comparable. The results show similar patterns, high frequency variations of the different proxies in the upper part of the record corresponding to MIS 3 and 2, as observed in western and eastern European sequences supporting then our assumption of the recording of N Atlantic abrupt changes over Europe. Other interesting variations are clearly demonstrated for every proxy making these results remarkable new data for individual in deep studies. Moreover our detailed investigation also shows new data about abrupt dust events, markers, in the lower part of the sequence, and previously interpreted as strong dust events, and how they appear within sedimentary cycles linked to the cyclicity at the base of the last climate cycle.

NFFA-Europe: enhancing European competitiveness in nanoscience research and innovation (Conference Presentation)

NASA Astrophysics Data System (ADS)

Carsughi, Flavio; Fonseca, Luis

2017-06-01

NFFA-EUROPE is an European open access resource for experimental and theoretical nanoscience and sets out a platform to carry out comprehensive projects for multidisciplinary research at the nanoscale extending from synthesis to nanocharacterization to theory and numerical simulation. Advanced infrastructures specialized on growth, nano-lithography, nano-characterization, theory and simulation and fine-analysis with Synchrotron, FEL and Neutron radiation sources are integrated in a multi-site combination to develop frontier research on methods for reproducible nanoscience research and to enable European and international researchers from diverse disciplines to carry out advanced proposals impacting science and innovation. NFFA-EUROPE will enable coordinated access to infrastructures on different aspects of nanoscience research that is not currently available at single specialized ones and without duplicating their specific scopes. Approved user projects will have access to the best suited instruments and support competences for performing the research, including access to analytical large scale facilities, theory and simulation and high-performance computing facilities. Access is offered free of charge to European users and users will receive a financial contribution for their travel, accommodation and subsistence costs. The users access will include several "installations" and will be coordinated through a single entry point portal that will activate an advanced user-infrastructure dialogue to build up a personalized access programme with an increasing return on science and innovation production. The own research activity of NFFA-EUROPE will address key bottlenecks of nanoscience research: nanostructure traceability, protocol reproducibility, in-operando nano-manipulation and analysis, open data.

The Virtual Observatory: I

NASA Astrophysics Data System (ADS)

Hanisch, R. J.

2014-11-01

The concept of the Virtual Observatory arose more-or-less simultaneously in the United States and Europe circa 2000. Ten pages of Astronomy and Astrophysics in the New Millennium: Panel Reports (National Academy Press, Washington, 2001), that is, the detailed recommendations of the Panel on Theory, Computation, and Data Exploration of the 2000 Decadal Survey in Astronomy, are dedicated to describing the motivation for, scientific value of, and major components required in implementing the National Virtual Observatory. European initiatives included the Astrophysical Virtual Observatory at the European Southern Observatory, the AstroGrid project in the United Kingdom, and the Euro-VO (sponsored by the European Union). Organizational/conceptual meetings were held in the US at the California Institute of Technology (Virtual Observatories of the Future, June 13-16, 2000) and at ESO Headquarters in Garching, Germany (Mining the Sky, July 31-August 4, 2000; Toward an International Virtual Observatory, June 10-14, 2002). The nascent US, UK, and European VO projects formed the International Virtual Observatory Alliance (IVOA) at the June 2002 meeting in Garching, with yours truly as the first chair. The IVOA has grown to a membership of twenty-one national projects and programs on six continents, and has developed a broad suite of data access protocols and standards that have been widely implemented. Astronomers can now discover, access, and compare data from hundreds of telescopes and facilities, hosted at hundreds of organizations worldwide, stored in thousands of databases, all with a single query.

Energy policy of the Czech Republic

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

Cerny, M.

1995-12-01

On February 16, 1992, the Government of the Czech Republic sanctioned, by its Decree No. 112/82, its first Energy Policy. Since that time, a number of conditions have changed: first of all, there was the partition of the former Federal Czechoslovak Republic, then the privatization of most of energy producing corporations, the deregulation of a significant proportion of power and energy commodities, the decision to bring to an end the construction of the Temelin nuclear power station, the creation of conditions for the construction of the Ingoldstadt oil pipeline, etc. These steps, on which the final decisions have been made,more » have brought about the necessity of updating the existing general Energy Policy. The updated Energy Policy is based on the Programme Statement by the Government of the Czech Republic of July 1992, as well as on other materials associated with energy and power generation, either approved or negotiated by the Government, in particular the State Environmental Policy the Rules of the State Raw Materials Policy, the European Association Agreement, the European Energy Charter, the results of the Uruguayan Round of GATT, the Convention on Climate Changes, the Ecological Action Programme for central and East-European countries, and other international documents that have either been, or are likely to be sanctioned by the Czech Government (especially the European Energy Charter Treaty, and the protocol on Trans-boundary Air Pollution and on Further Reduction of Sulphur Oxide Emissions).« less

Assessing and Improving the Quality of Food Composition Databases for Nutrition and Health Applications in Europe: The Contribution of EuroFIR123

PubMed Central

Finglas, Paul M.; Berry, Rachel; Astley, Siân

2014-01-01

Food composition databases (FCDBs) form an integral part of nutrition and health research, patient treatment, manufacturing processes, and consumer information. FCDBs have traditionally been compiled at a national level; therefore, until recently, there was limited standardization of procedures across different data sets. Digital technologies now allow FCDB users to access a variety of information from different sources, which has emphasized the need for greater harmonization. The European Food Information Resource (EuroFIR) Network of Excellence and Nexus projects (2005–2013) has been instrumental in addressing differences in FCDBs and in producing standardized protocols and quality schemes to compile and manage them. A formal, recognized European standard for food composition data has been prepared, which will further assist in the production of comparable data. Quality schemes need to address both the composition data, plus the methods of sampling, analysis, and calculation, and the documentation of processes. The EuroFIR data exchange platform provides a wealth of resources for composition compilers and end users and continues to develop new and innovative tools and methodologies. EuroFIR also is working in collaboration with the European Food Safety Authority, and as a partner in several European projects. Through such collaborations, EuroFIR will continue to develop FCDB harmonization and to use new technologies to ensure sustainable future initiatives in the food composition activities that underpin food and health research in Europe. PMID:25469406

Exposure to benzodiazepines (anxiolytics, hypnotics and related drugs) in seven European electronic healthcare databases: a cross-national descriptive study from the PROTECT-EU Project.

PubMed

Huerta, Consuelo; Abbing-Karahagopian, Victoria; Requena, Gema; Oliva, Belén; Alvarez, Yolanda; Gardarsdottir, Helga; Miret, Montserrat; Schneider, Cornelia; Gil, Miguel; Souverein, Patrick C; De Bruin, Marie L; Slattery, Jim; De Groot, Mark C H; Hesse, Ulrik; Rottenkolber, Marietta; Schmiedl, Sven; Montero, Dolores; Bate, Andrew; Ruigomez, Ana; García-Rodríguez, Luis Alberto; Johansson, Saga; de Vries, Frank; Schlienger, Raymond G; Reynolds, Robert F; Klungel, Olaf H; de Abajo, Francisco José

2016-03-01

Studies on drug utilization usually do not allow direct cross-national comparisons because of differences in the respective applied methods. This study aimed to compare time trends in BZDs prescribing by applying a common protocol and analyses plan in seven European electronic healthcare databases. Crude and standardized prevalence rates of drug prescribing from 2001-2009 were calculated in databases from Spain, United Kingdon (UK), The Netherlands, Germany and Denmark. Prevalence was stratified by age, sex, BZD type [(using ATC codes), i.e. BZD-anxiolytics BZD-hypnotics, BZD-related drugs and clomethiazole], indication and number of prescription. Crude prevalence rates of BZDs prescribing ranged from 570 to 1700 per 10,000 person-years over the study period. Standardization by age and sex did not substantially change the differences. Standardized prevalence rates increased in the Spanish (+13%) and UK databases (+2% and +8%) over the study period, while they decreased in the Dutch databases (-4% and -22%), the German (-12%) and Danish (-26%) database. Prevalence of anxiolytics outweighed that of hypnotics in the Spanish, Dutch and Bavarian databases, but the reverse was shown in the UK and Danish databases. Prevalence rates consistently increased with age and were two-fold higher in women than in men in all databases. A median of 18% of users received 10 or more prescriptions in 2008. Although similar methods were applied, the prevalence of BZD prescribing varied considerably across different populations. Clinical factors related to BZDs and characteristics of the databases may explain these differences. Copyright © 2015 John Wiley & Sons, Ltd.

The ADVANCE Code of Conduct for collaborative vaccine studies.

PubMed

Kurz, Xavier; Bauchau, Vincent; Mahy, Patrick; Glismann, Steffen; van der Aa, Lieke Maria; Simondon, François

2017-04-04

Lessons learnt from the 2009 (H1N1) flu pandemic highlighted factors limiting the capacity to collect European data on vaccine exposure, safety and effectiveness, including lack of rapid access to available data sources or expertise, difficulties to establish efficient interactions between multiple parties, lack of confidence between private and public sectors, concerns about possible or actual conflicts of interest (or perceptions thereof) and inadequate funding mechanisms. The Innovative Medicines Initiative's Accelerated Development of VAccine benefit-risk Collaboration in Europe (ADVANCE) consortium was established to create an efficient and sustainable infrastructure for rapid and integrated monitoring of post-approval benefit-risk of vaccines, including a code of conduct and governance principles for collaborative studies. The development of the code of conduct was guided by three core and common values (best science, strengthening public health, transparency) and a review of existing guidance and relevant published articles. The ADVANCE Code of Conduct includes 45 recommendations in 10 topics (Scientific integrity, Scientific independence, Transparency, Conflicts of interest, Study protocol, Study report, Publication, Subject privacy, Sharing of study data, Research contract). Each topic includes a definition, a set of recommendations and a list of additional reading. The concept of the study team is introduced as a key component of the ADVANCE Code of Conduct with a core set of roles and responsibilities. It is hoped that adoption of the ADVANCE Code of Conduct by all partners involved in a study will facilitate and speed-up its initiation, design, conduct and reporting. Adoption of the ADVANCE Code of Conduct should be stated in the study protocol, study report and publications and journal editors are encouraged to use it as an indication that good principles of public health, science and transparency were followed throughout the study. Copyright © 2017. Published by Elsevier Ltd.

Quality assured measurements of animal building emissions: odor concentrations.

PubMed

Jacobson, Larry D; Hetchler, Brian P; Schmidt, David R; Nicolai, Richard E; Heber, Albert J; Ni, Ji-Qin; Hoff, Steven J; Koziel, Jacek A; Zhang, Yuanhui; Beasley, David B; Parker, David B

2008-06-01

Standard protocols for sampling and measuring odor emissions from livestock buildings are needed to guide scientists, consultants, regulators, and policy-makers. A federally funded, multistate project has conducted field studies in six states to measure emissions of odor, coarse particulate matter (PM(10)), total suspended particulates, hydrogen sulfide, ammonia, and carbon dioxide from swine and poultry production buildings. The focus of this paper is on the intermittent measurement of odor concentrations at nearly identical pairs of buildings in each state and on protocols to minimize variations in these measurements. Air was collected from pig and poultry barns in small (10 L) Tedlar bags through a gas sampling system located in an instrument trailer housing gas and dust analyzers. The samples were analyzed within 30 hr by a dynamic dilution forced-choice olfactometer (a dilution apparatus). The olfactometers (AC'SCENT International Olfactometer, St. Croix Sensory, Inc.) used by all participating laboratories meet the olfactometry standards (American Society for Testing and Materials and European Committee for Standardization [CEN]) in the United States and Europe. Trained panelists (four to eight) at each laboratory measured odor concentrations (dilution to thresholds [DT]) from the bag samples. Odor emissions were calculated by multiplying odor concentration differences between inlet and outlet air by standardized (20 degrees C and 1 atm) building airflow rates.

GMP-based CD133+ cells isolation maintains progenitor angiogenic properties and enhances standardization in cardiovascular cell therapy

PubMed Central

Gaipa, Giuseppe; Tilenni, Manuela; Straino, Stefania; Burba, Ilaria; Zaccagnini, Germana; Belotti, Daniela; Biagi, Ettore; Valentini, Marco; Perseghin, Paolo; Parma, Matteo; Campli, Cristiana Di; Biondi, Andrea; Capogrossi, Maurizio C; Pompilio, Giulio; Pesce, Maurizio

2010-01-01

Abstract The aim of the present study was to develop and validate a good manufacturing practice (GMP) compliant procedure for the preparation of bone marrow (BM) derived CD133+ cells for cardiovascular repair. Starting from available laboratory protocols to purify CD133+ cells from human cord blood, we implemented these procedures in a GMP facility and applied quality control conditions defining purity, microbiological safety and vitality of CD133+ cells. Validation of CD133+ cells isolation and release process were performed according to a two-step experimental program comprising release quality checking (step 1) as well as ‘proofs of principle’ of their phenotypic integrity and biological function (step 2). This testing program was accomplished using in vitro culture assays and in vivo testing in an immunosuppressed mouse model of hindlimb ischemia. These criteria and procedures were successfully applied to GMP production of CD133+ cells from the BM for an ongoing clinical trial of autologous stem cells administration into patients with ischemic cardiomyopathy. Our results show that GMP implementation of currently available protocols for CD133+ cells selection is feasible and reproducible, and enables the production of cells having a full biological potential according to the most recent quality requirements by European Regulatory Agencies. PMID:19627397

Whither papillon? Future directions for contact radiotherapy in rectal cancer.

PubMed

Lindegaard, J; Gerard, J P; Sun Myint, A; Myerson, R; Thomsen, H; Laurberg, S

2007-11-01

Although contact radiotherapy was developed 70 years ago, and is highly effective with cure rates of over 90% for early rectal cancer, there are few centres that offer this treatment today. One reason is the lack of replacement of ageing contact X-ray machines, many of which are now over 30 years old. To address this problem, the International Contact Radiotherapy Evaluation (ICONE) group was formed at a meeting in Liverpool in 2005 with the aim of developing a new contact X-ray unit and to establish clinical protocols that would enable the new machine to safely engage in the treatment of rectal cancer. As a result of these efforts, a European company is starting production of the new Papillon RT-50 machine, which will be available shortly. In addition, the ICONE group is planning an observational study on contact X-ray and transanal endoscopic microsurgery (CONTEM) for curative treatment of rectal cancer. This protocol will ensure standardised diagnostic procedures, patient selection and treatment in centres across the world and the data will be collected prospectively for analysis and audit. It is hoped that the CONTEM trial will provide the scientific evidence that is needed to obtain a broader acceptance of local contact radiotherapy as a treatment option for selected cases with early stage rectal cancer.

Applicability of the "Frame of Reference" approach for environmental monitoring of offshore renewable energy projects.

PubMed

Garel, Erwan; Rey, Cibran Camba; Ferreira, Oscar; van Koningsveld, Mark

2014-08-01

This paper assesses the applicability of the Frame of Reference (FoR) approach for the environmental monitoring of large-scale offshore Marine Renewable Energy (MRE) projects. The focus is on projects harvesting energy from winds, waves and currents. Environmental concerns induced by MRE projects are reported based on a classification scheme identifying stressors, receptors, effects and impacts. Although the potential effects of stressors on most receptors are identified, there are large knowledge gaps regarding the corresponding (positive and negative) impacts. In that context, the development of offshore MRE requires the implementation of fit-for-purpose monitoring activities aimed at environmental protection and knowledge development. Taking European legislation as an example, it is suggested to adopt standardized monitoring protocols for the enhanced usage and utility of environmental indicators. Towards this objective, the use of the FoR approach is advocated since it provides guidance for the definition and use of coherent set of environmental state indicators. After a description of this framework, various examples of applications are provided considering a virtual MRE project located in European waters. Finally, some conclusions and recommendations are provided for the successful implementation of the FoR approach and for future studies. Copyright © 2014 Elsevier Ltd. All rights reserved.

Improving Suicide Prevention in Dutch Regions by Creating Local Suicide Prevention Action Networks (SUPRANET): A Study Protocol.

PubMed

Gilissen, Renske; De Beurs, Derek; Mokkenstorm, Jan; Mérelle, Saskia; Donker, Gé; Terpstra, Sanne; Derijck, Carla; Franx, Gerdien

2017-03-28

The European Alliance against Depression (EAAD) program is to be introduced in The Netherlands from 2017 onwards. This program to combat suicide consists of interventions on four levels: (1) increasing the awareness of suicide by local media campaigns; (2) training local gatekeepers, such as teachers or police officers; (3) targeting high-risk persons in the community; and (4) training and support of professionals in primary care settings. The implementation starts in seven Dutch pilot regions. Each region is designated as a Suicide Prevention Action NETwork (SUPRANET). This paper describes the SUPRANET program components and the evaluation of its feasibility and impact. The findings will be used to facilitate the national implementation of EAAD in The Netherlands and to add new findings to the existing literature on EAAD.

A System for Information Management in BioMedical Studies—SIMBioMS

PubMed Central

Krestyaninova, Maria; Zarins, Andris; Viksna, Juris; Kurbatova, Natalja; Rucevskis, Peteris; Neogi, Sudeshna Guha; Gostev, Mike; Perheentupa, Teemu; Knuuttila, Juha; Barrett, Amy; Lappalainen, Ilkka; Rung, Johan; Podnieks, Karlis; Sarkans, Ugis; McCarthy, Mark I; Brazma, Alvis

2009-01-01

Summary: SIMBioMS is a web-based open source software system for managing data and information in biomedical studies. It provides a solution for the collection, storage, management and retrieval of information about research subjects and biomedical samples, as well as experimental data obtained using a range of high-throughput technologies, including gene expression, genotyping, proteomics and metabonomics. The system can easily be customized and has proven to be successful in several large-scale multi-site collaborative projects. It is compatible with emerging functional genomics data standards and provides data import and export in accepted standard formats. Protocols for transferring data to durable archives at the European Bioinformatics Institute have been implemented. Availability: The source code, documentation and initialization scripts are available at http://simbioms.org. Contact: support@simbioms.org; mariak@ebi.ac.uk PMID:19633095

Improving Suicide Prevention in Dutch Regions by Creating Local Suicide Prevention Action Networks (SUPRANET): A Study Protocol

PubMed Central

Gilissen, Renske; De Beurs, Derek; Mokkenstorm, Jan; Mérelle, Saskia; Donker, Gé; Terpstra, Sanne; Derijck, Carla; Franx, Gerdien

2017-01-01

The European Alliance against Depression (EAAD) program is to be introduced in The Netherlands from 2017 onwards. This program to combat suicide consists of interventions on four levels: (1) increasing the awareness of suicide by local media campaigns; (2) training local gatekeepers, such as teachers or police officers; (3) targeting high-risk persons in the community; and (4) training and support of professionals in primary care settings. The implementation starts in seven Dutch pilot regions. Each region is designated as a Suicide Prevention Action NETwork (SUPRANET). This paper describes the SUPRANET program components and the evaluation of its feasibility and impact. The findings will be used to facilitate the national implementation of EAAD in The Netherlands and to add new findings to the existing literature on EAAD. PMID:28350367

Agreement on urgency assessment between secretaries and general practitioners: an observational study in out-of-hours general practice service in Belgium.

PubMed

Philips, H; Van Bergen, J; Huibers, L; Colliers, A; Bartholomeeusen, S; Coenen, S; Remmen, R

2015-10-01

In some European countries telephone triage (TT) during out-of-hours primary care showed to be safe and effective. Other countries, such as Belgium, may not have trained auxiliary personnel while their national health services want to establish TT. To compare urgency levels assessed by secretaries and general practitioners in one general practice cooperative in Belgium. Percentage of correct-, under-, and over-triage were calculated in total and per reason for encounter. Inter-rater agreement was investigated. The secretaries correctly triaged (same urgency level) 77% of the telephone calls, under-triaged 10% and over-triaged 13%.'Shortness of breath', 'skin cuts', 'chest pain', 'feeling unwell' and 'syncope' were often under-triaged. Before introducing TT, auxiliary staff should be trained and protocols should be used.

Temporal bone bank: complying with European Union directives on human tissue and cells.

PubMed

Van Rompaey, Vincent; Vandamme, Wouter; Muylle, Ludo; Van de Heyning, Paul H

2012-06-01

Availability of allograft tympano-ossicular systems (ATOS) provides unique reconstructive capabilities, allowing more radical removal of middle ear pathology. To provide ATOS, the University of Antwerp Temporal Bone Bank (UATB) was established in 1988. ATOS use was stopped in many countries because of safety issues concerning human tissue transplantation. Our objective was to maintain an ATOS tissue bank complying with European Union (EU) directives on human tissues and cells. The guidelines of the Belgian Superior Health Council, including EU directive requirements, were rigorously applied to UATB infrastructure, workflow protocols and activity. Workflow protocols were updated and an internal audit was performed to check and improve consistency with established quality systems and changing legislations. The Belgian Federal Agency of Medicines and Health Products performed an inspection to examine compliance with national legislatives and EU directives on human tissues and cells. A sample of important procedures was meticulously examined in its workflow setting next to assessment of the infrastructure and personnel. Results are reported on infrastructure, personnel, administrative workflow, procurement, preparation, processing, distribution, internal audit and inspection by the competent authority. Donors procured: 2006, 93 (45.1%); 2007, 64 (20.6%); 2008, 56 (13.1%); 2009, 79 (6.9%). The UATB was approved by the Minister of Health without critical or important shortcomings. The Ministry accords registration each time for 2 years. An ATOS tissue bank complying with EU regulations on human allografts is feasible and critical to assure that the patient receives tissue, which is safe, individually checked and prepared in a suitable environment.

Foodborne and waterborne pathogenic bacteria in selected Organisation for Economic Cooperation and Development (OECD) countries.

PubMed

Curtis, Dennis; Hill, Arthur; Wilcock, Anne; Charlebois, Sylvain

2014-10-01

The World Ranking Food Safety Performance reports by Charlebois in 2008 and 2010 importantly stimulated international discussion and encouraged efforts to establish realistic international benchmarks for food safety performance among Organisation for Economic Cooperation and Development (OECD) countries. This paper presents the international incidence of 5 common foodborne pathogens and describes the challenges of comparing international data. Data were compiled from surveillance authorities in the countries, such as the Natl. Notifiable Diseases Surveillance System of Australia; the Canadian Notifiable Diseases Surveillance System; the European Food Safety Authority, EFSA; the Ministry of Health, Labour and Welfare of Japan; New Zealand Food Safety Authority; and the U.S. Center for Disease Control and Prevention. The highest average rates in cases per 100000 people over the 12-y period from 2000 to 2011 for Campylobacter spp. (237.47), Salmonella spp. (67.08), Yersinia spp. (12.09), Verotoxigenic/Shiga toxin producing Escherichia coli (3.38), and Listeria monocytogenes (1.06) corresponded, in order, to New Zealand, Belgium, Finland, Canada, and Denmark. Comparatively, annual average rates for these 5 pathogens showed an increase over the 12-y period in 28%, 17%, 14%, 50%, and 6% of the countries for which data were available. Salmonella spp. showed a decrease in 56% of the countries, while incidence of L. monocytogenes was constant in most countries (94%). Variable protocols for monitoring incidence of pathogens among OECD countries remain. Nevertheless, there is evidence of sufficient standardization of monitoring protocols such as the European Surveillance System, which has contributed to reduce this gap. © 2014 Institute of Food Technologists®

Proposed primary endpoints for use in clinical trials that compare treatment options for bloodstream infection in adults: a consensus definition.

PubMed

Harris, P N A; McNamara, J F; Lye, D C; Davis, J S; Bernard, L; Cheng, A C; Doi, Y; Fowler, V G; Kaye, K S; Leibovici, L; Lipman, J; Llewelyn, M J; Munoz-Price, S; Paul, M; Peleg, A Y; Rodríguez-Baño, J; Rogers, B A; Seifert, H; Thamlikitkul, V; Thwaites, G; Tong, S Y C; Turnidge, J; Utili, R; Webb, S A R; Paterson, D L

2017-08-01

To define standardized endpoints to aid the design of trials that compare antibiotic therapies for bloodstream infections (BSI). Prospective studies, randomized trials or registered protocols comparing antibiotic therapies for BSI, published from 2005 to 2016, were reviewed. Consensus endpoints for BSI studies were defined using a modified Delphi process. Different primary and secondary endpoints were defined for pilot (small-scale studies designed to evaluate protocol design, feasibility and implementation) and definitive trials (larger-scale studies designed to test hypotheses and influence clinical practice), as well as for Staphylococcus aureus and Gram-negative BSI. For pilot studies of S. aureus BSI, a primary outcome of success at day 7 was defined by: survival, resolution of fever, stable/improved Sequential Organ Failure Assessment (SOFA) score and clearance of blood cultures, with no microbiologically confirmed failure up to 90 days. For definitive S. aureus BSI studies, a primary outcome of success at 90 days was defined by survival and no microbiologically confirmed failure. For pilot studies of Gram-negative BSI, a primary outcome of success at day 7 was defined by: survival, resolution of fever and symptoms related to BSI source, stable or improved SOFA score and negative blood cultures. For definitive Gram-negative BSI studies, a primary outcome of survival at 90 days supported by a secondary outcome of success at day 7 (as previously defined) was agreed. These endpoints provide a framework to aid future trial design. Further work will be required to validate these endpoints with respect to patient-centred clinical outcomes. Copyright © 2016 European Society of Clinical Microbiology and Infectious Diseases. All rights reserved.

Phenotypes of organ involvement in sarcoidosis.

PubMed

Schupp, Jonas Christian; Freitag-Wolf, Sandra; Bargagli, Elena; Mihailović-Vučinić, Violeta; Rottoli, Paola; Grubanovic, Aleksandar; Müller, Annegret; Jochens, Arne; Tittmann, Lukas; Schnerch, Jasmin; Olivieri, Carmela; Fischer, Annegret; Jovanovic, Dragana; Filipovic, Snežana; Videnovic-Ivanovic, Jelica; Bresser, Paul; Jonkers, René; O'Reilly, Kate; Ho, Ling-Pei; Gaede, Karoline I; Zabel, Peter; Dubaniewicz, Anna; Marshall, Ben; Kieszko, Robert; Milanowski, Janusz; Günther, Andreas; Weihrich, Anette; Petrek, Martin; Kolek, Vitezslav; Keane, Michael P; O'Beirne, Sarah; Donnelly, Seamas; Haraldsdottir, Sigridur Olina; Jorundsdottir, Kristin B; Costabel, Ulrich; Bonella, Francesco; Wallaert, Benoît; Grah, Christian; Peroš-Golubičić, Tatjana; Luisetti, Mauritio; Kadija, Zamir; Pabst, Stefan; Grohé, Christian; Strausz, János; Vašáková, Martina; Sterclova, Martina; Millar, Ann; Homolka, Jiří; Slováková, Alena; Kendrick, Yvonne; Crawshaw, Anjali; Wuyts, Wim; Spencer, Lisa; Pfeifer, Michael; Valeyre, Dominique; Poletti, Venerino; Wirtz, Hubertus; Prasse, Antje; Schreiber, Stefan; Krawczak, Michael; Müller-Quernheim, Joachim

2018-01-01

Sarcoidosis is a highly variable, systemic granulomatous disease of hitherto unknown aetiology. The GenPhenReSa (Genotype-Phenotype Relationship in Sarcoidosis) project represents a European multicentre study to investigate the influence of genotype on disease phenotypes in sarcoidosis.The baseline phenotype module of GenPhenReSa comprised 2163 Caucasian patients with sarcoidosis who were phenotyped at 31 study centres according to a standardised protocol.From this module, we found that patients with acute onset were mainly female, young and of Scadding type I or II. Female patients showed a significantly higher frequency of eye and skin involvement, and complained more of fatigue. Based on multidimensional correspondence analysis and subsequent cluster analysis, patients could be clearly stratified into five distinct, yet undescribed, subgroups according to predominant organ involvement: 1) abdominal organ involvement, 2) ocular-cardiac-cutaneous-central nervous system disease involvement, 3) musculoskeletal-cutaneous involvement, 4) pulmonary and intrathoracic lymph node involvement, and 5) extrapulmonary involvement.These five new clinical phenotypes will be useful to recruit homogenous cohorts in future biomedical studies. Copyright ©ERS 2018.

Bioaccessibility of As, Cd, Cu, Ni, Pb, and Sb in toys and low-cost jewelry.

PubMed

Guney, Mert; Zagury, Gerald J

2014-01-21

Children can be exposed to toxic elements in toys and jewelry following ingestion. As, Cd, Cu, Ni, Pb, and Sb bioavailability was assessed (n = 24) via the in vitro gastrointestinal protocol (IVG), the physiologically based extraction test (PBET), and the European Toy Safety Standard protocol (EN 71-3), and health risks were characterized. Cd, Cu, Ni, and Pb were mobilized from 19 metallic toys and jewelry (MJ) and one crayon set. Bioaccessible Cd, Ni, or Pb exceeded EU migratable concentration limits in four to six MJ, depending on the protocol. Using two-phase (gastric + intestinal) IVG or PBET might be preferable over EN 71-3 since they better represent gastrointestinal physiology. Bioaccessible and total metal concentrations were different and not always correlated, indicating that bioaccessibility measurement may provide more accurate risk characterization. More information on impacts of multiple factors affecting metals mobilization from toys and jewelry is needed before recommending specific tests. Hazard index (HI) for Cd, Ni, or Pb were >1 for all six MJ exceeding the EU limits. For infants (6-12 mo old), 10 MJ had HI > 1 for Cd, Cu, Ni, or Pb (up to 75 for Cd and 43 for Pb). Research on prolonged exposure to MJ and comprehensive risk characterization for toys and jewelry exposure is recommended.

Preliminary results from the MAESTRO 1 Campaign over the Black Forest

NASA Technical Reports Server (NTRS)

Churchill, P. N.; Degrandi, G.; Sieber, A. J.

1990-01-01

The Joint Research Center (JRC) Ispra and the European Space Agency (ESA) have co-sponsored the deployment of the National Aeronautics and Space Agency (NASA) and Jet Propulsion Laboratory (JPL), C-, L-, and P-band polarimetric synthetic aperture radar (SAR) in Europe in mid-August 1989. This deployment represents the first opportunity for European agencies and institutes to evaluate the current state of the art of multifrequency polarimetric imaging technology over European Test Sites. Of particular interest to the Joint Research Center (JRC) Ispra is the Black Forest Test Site at Freiburg in the Federal Republic of Germany. This Test Site incorporates the Villingen region of the Black Forest to the south-west of Germany. This paper reports upon the activities undertaken in preparation for the MAESTRO 1 Campaign in the Black Forest Test Site. In particular this paper reports upon the ground data collection campaign for the Freiburg Test Site where extensive and intensive ground data measurements were undertaken. These measurements were based upon standard ground data collection protocols developed for forestry by the JRC and utilized throughout Europe for the MAESTRO 1 Campaign. The paper then goes on to present preliminary results derived from the SAR data using the JRC-developed software for polarimetric data interpretation, POLTOOL.

FIRST EURADOS INTERCOMPARISON EXERCISE OF EYE LENS DOSEMETERS FOR MEDICAL APPLICATIONS.

PubMed

Clairand, I; Ginjaume, M; Vanhavere, F; Carinou, E; Daures, J; Denoziere, M; Silva, E H; Roig, M; Principi, S; Van Rycheghem, L

2016-09-01

In the context of the decrease in the eye lens dose limit for occupational exposure to 20 mSv per year stated by the recent revision of the European Basic Safety Standards Directive 2013/59/EURATOM, the European Radiation Dosimetry Group (EURADOS) has organised in 2014, for the first time, an intercomparison exercise for eye lens dosemeters. The main objective was to assess the capabilities of the passive eye lens dosemeters currently in use in Europe for occupational monitoring in medical fields. A total of 20 European individual monitoring services from 15 different countries have participated. The dosemeters provided by the participants were all composed of thermoluminescent detectors, of various types and designs. The irradiations were carried out with several photon fields chosen to cover the energy and angle ranges encountered in medical workplace. Participants were asked to report the doses in terms of Hp(3) using their routine protocol. The results provided by each participant were compared with the reference delivered doses. All the results were anonymously analysed. Results are globally satisfactory since, among the 20 participants, 17 were able to provide 90 % of their response in accordance with the ISO 14146 standard requirements. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Validation study of the in vitro skin irritation test with the LabCyte EPI-MODEL24.

PubMed

Kojima, Hajime; Ando, Yoko; Idehara, Kenji; Katoh, Masakazu; Kosaka, Tadashi; Miyaoka, Etsuyoshi; Shinoda, Shinsuke; Suzuki, Tamie; Yamaguchi, Yoshihiro; Yoshimura, Isao; Yuasa, Atsuko; Watanabe, Yukihiko; Omori, Takashi

2012-03-01

A validation study on an in vitro skin irritation assay was performed with the reconstructed human epidermis (RhE) LabCyte EPI-MODEL24, developed by Japan Tissue Engineering Co. Ltd (Gamagori, Japan). The protocol that was followed in the current study was an optimised version of the EpiSkin protocol (LabCyte assay). According to the United Nations Globally Harmonised System (UN GHS) of classification for assessing the skin irritation potential of a chemical, 12 irritants and 13 non-irritants were validated by a minimum of six laboratories from the Japanese Society for Alternatives to Animal Experiments (JSAAE) skin irritation assay validation study management team (VMT). The 25 chemicals were listed in the European Centre for the Validation of Alternative Methods (ECVAM) performance standards. The reconstructed tissues were exposed to the chemicals for 15 minutes and incubated for 42 hours in fresh culture medium. Subsequently, the level of interleukin-1 alpha (IL-1 α) present in the conditioned medium was measured, and tissue viability was assessed by using the MTT assay. The results of the MTT assay obtained with the LabCyte EPI-MODEL24 (LabCyte MTT assay) demonstrated high within-laboratory and between-laboratory reproducibility, as well as high accuracy for use as a stand-alone assay to distinguish skin irritants from non-irritants. In addition, the IL-1α release measurements in the LabCyte assay were clearly unnecessary for the success of this model in the classification of chemicals for skin irritation potential. 2012 FRAME.

European viper envenomation recorded by French poison control centers: A clinical assessment and management study.

PubMed

Jollivet, V; Hamel, J F; de Haro, L; Labadie, M; Sapori, J M; Cordier, L; Villa, A; Nisse, P; Puskarczyk, E; Berthelon, L; Harry, P; Boels, D

2015-12-15

Immunotherapy is the gold standard treatment for patients bitten by European vipers in France; it significantly decreases morbidity, frequency and severity of complications and length of stay. A national prospective study was performed by all Poison Control Centers (PCC) to validate the emergency protocol for viper envenomations. This prospective study included all cases of viper bites in France, treated or not with Viperfav(®) in 2013. In 2013, 277 cases of viper bites were collected: ratio M/F 2.1; mean aged 43 years (<15 years 25% 15-65 63% > 65 12%). The final severity was divided into 68 grades 0, 58 grades I, 62 grades IIA, 71 grades IIB and 18 grades III. One death was reported. Five patients had neurological signs. For the 114 patients who received Viperfav(®), all systemic signs disappeared in 5 h and in 24 h for biological and neurological signs. No severe anaphylactic reaction with Viperfav(®) was reported. Late Viperfav(®) administration increased the risk of functional impairment 15 days after the bite (OR = 3.21 p = 0.043). The administration of Low Molecular Weight Heparin (LMWH) increased the frequency of functional impairment to 15 days after the bite (OR = 6.38 p = 0.064), although Viperfav(®) was given in the first 18 h. This study confirms the efficiency, safety and recommendation of an early administration of a single dose of Viperfav(®), LMWH should not be used. It also shows the extension of neurotoxic venom of vipers in France. Copyright © 2015 Elsevier Ltd. All rights reserved.

Development of a real-time PCR protocol for the species origin confirmation of isolated animal particles detected by NIRM.

PubMed

Fumière, O; Marien, A; Fernández Pierna, J A; Baeten, V; Berben, G

2010-08-01

At present, European legislation prohibits totally the use of processed animal proteins in feed for all farmed animals (Commission Regulation (EC) No. 1234/2003-extended feed ban). A softening of the feed ban for non-ruminants would nevertheless be considered if alternative methods could be used to gain more information concerning the species origin of processed animal proteins than that which can be provided by classical optical microscopy. This would allow control provisions such as the ban of feeding animals with proteins from the same species or intra-species recycling (Regulation (EC) No. 1774/2002). Two promising alternative methods, near-infrared microscopy (NIRM) and real-time polymerase chain reaction (PCR), were combined to authenticate, at the species level, the presence of animal particles. The paper describes the improvements of the real-time PCR method made to the DNA extraction protocol, allowing five PCR analyses to be performed with the DNA extracted from a single particle.

Protocols for Scholarly Communication

NASA Astrophysics Data System (ADS)

Pepe, A.; Yeomans, J.

2007-10-01

CERN, the European Organization for Nuclear Research, has operated an institutional preprint repository for more than 10 years. The repository contains over 850,000 records of which more than 450,000 are full-text OA preprints, mostly in the field of particle physics, and it is integrated with the library's holdings of books, conference proceedings, journals and other grey literature. In order to encourage effective propagation and open access to scholarly material, CERN is implementing a range of innovative library services into its document repository: automatic keywording, reference extraction, collaborative management tools and bibliometric tools. Some of these services, such as user reviewing and automatic metadata extraction, could make up an interesting testbed for future publishing solutions and certainly provide an exciting environment for e-science possibilities. The future protocol for scientific communication should guide authors naturally towards OA publication, and CERN wants to help reach a full open access publishing environment for the particle physics community and related sciences in the next few years.

Wireless optical network for a home network

NASA Astrophysics Data System (ADS)

Bouchet, Olivier; Porcon, Pascal; Walewski, Joachim W.; Nerreter, Stefan; Langer, Klaus-Dieter; Fernández, Luz; Vucic, Jelena; Kamalakis, Thomas; Ntogari, Georgia; Neokosmidis, Ioannis; Gueutier, Eric

2010-08-01

During the European collaborative project OMEGA, two optical-wireless prototypes have been developed. The first prototype operates in the near-infrared spectral region and features Giga Ethernet connectivity, a simple transceiver architecture due to the use of on-off keying, a multi-sector transceiver, and an ultra-fast switch for sector-to-sector hand over. This full-duplex system, composed by one base station and one module, transmits data on three meters. The second prototype is a visible-light-communications system based on DMT signal processing and an adapted MAC sublayer. Data rates around to 100 Mb/s at the physical layer are achieved. This broadcast system, composed also by one base station and one module, transmits data up to two meters. In this paper we present the adapted optical wireless media-access-control sublayer protocol for visible-light communications. This protocol accommodates link adaptation from 128 Mb/s to 1024 Mb/s with multi-sector coverage, and half-duplex or full-duplex transmission.

Doxycycline in the treatment of respiratory tract infections. Results of a pan-European multi-centre trial.

PubMed

Pestel, M

1975-01-01

In the winter of 1973-4, general practitioners from seven European countries took part in a multi-centre trial of doxycycline in the treatment of infections of the respiratory tract. The carefully designed protocol was observed by all participants. A total of 1,747 patients were admitted to the trial; their ages ranged from 6 years to over 80. The commonest diagnoses (50%) were acute bronchitis and acute exacerbations of chronic bronchitis. On the recommended dosage of 200 mg doxycycline on the first day, followed by 100 mg daily thereafter (though 200 mg could be continued daily in severe cases), 87% of patients achieved good or very good results. Both subjective (pain) and objective (sputum volume and viscosity, temperature, cough) measures showed rapid improvement, usually by the third to fifth days. Side-effects were minimal and mainly gastrointestinal and caused only 4 patients to discontinue treatment. Overall, doxycycline proved its effectiveness and rapidity of action.

Study protocol of European Fans in Training (EuroFIT): a four-country randomised controlled trial of a lifestyle program for men delivered in elite football clubs.

PubMed

van Nassau, Femke; van der Ploeg, Hidde P; Abrahamsen, Frank; Andersen, Eivind; Anderson, Annie S; Bosmans, Judith E; Bunn, Christopher; Chalmers, Matthew; Clissmann, Ciaran; Gill, Jason M R; Gray, Cindy M; Hunt, Kate; Jelsma, Judith G M; La Guardia, Jennifer G; Lemyre, Pierre N; Loudon, David W; Macaulay, Lisa; Maxwell, Douglas J; McConnachie, Alex; Martin, Anne; Mourselas, Nikos; Mutrie, Nanette; Nijhuis-van der Sanden, Ria; O'Brien, Kylie; Pereira, Hugo V; Philpott, Matthew; Roberts, Glyn C; Rooksby, John; Rost, Mattias; Røynesdal, Øystein; Sattar, Naveed; Silva, Marlene N; Sorensen, Marit; Teixeira, Pedro J; Treweek, Shaun; van Achterberg, Theo; van de Glind, Irene; van Mechelen, Willem; Wyke, Sally

2016-07-19

Lifestyle interventions targeting physical activity, sedentary time and dietary behaviours have the potential to initiate and support behavioural change and result in public health gain. Although men have often been reluctant to engage in such lifestyle programs, many are at high risk of several chronic conditions. We have developed an evidence and theory-based, gender sensitised, health and lifestyle program (European Fans in Training (EuroFIT)), which is designed to attract men through the loyalty they feel to the football club they support. This paper describes the study protocol to evaluate the effectiveness and cost-effectiveness of the EuroFIT program in supporting men to improve their level of physical activity and reduce sedentary behaviour over 12 months. The EuroFIT study is a pragmatic, two-arm, randomised controlled trial conducted in 15 football clubs in the Netherlands, Norway, Portugal and the UK (England). One-thousand men, aged 30 to 65 years, with a self-reported Body Mass Index (BMI) ≥27 kg/m(2) will be recruited and individually randomised. The primary outcomes are objectively-assessed changes in total physical activity (steps per day) and total sedentary time (minutes per day) at 12 months after baseline assessment. Secondary outcomes are weight, BMI, waist circumference, resting systolic and diastolic blood pressure, cardio-metabolic blood biomarkers, food intake, self-reported physical activity and sedentary time, wellbeing, self-esteem, vitality and quality of life. Cost-effectiveness will be assessed and a process evaluation conducted. The EuroFIT program will be delivered over 12 weekly, 90-minute sessions that combine classroom discussion with graded physical activity in the setting of the football club. Classroom sessions provide participants with a toolbox of behaviour change techniques to initiate and sustain long-term lifestyle changes. The coaches will receive two days of training to enable them to create a positive social environment that supports men in engaging in sustained behaviour change. The EuroFIT trial will provide evidence on the effectiveness and cost-effectiveness of the EuroFIT program delivered by football clubs to their male fans, and will offer insight into factors associated with success in making sustained changes to physical activity, sedentary behaviour, and secondary outcomes, such as diet. 81935608 . Registered 16 June 2015.

European Collaboration on Low-dose Aspirin in Polycythemia Vera (ECLAP): a randomized trial.

PubMed

Landolfi, R; Marchioli, R

1997-01-01

Thrombotic complications characterize the clinical course of polycythemia vera (PV) and represent the main cause of morbidity and mortality. However, uncertainty still exists as to the benefit/risk ratio of aspirin prophylaxis in this setting. In vivo platelet biosynthesis of thromboxane A2 is enhanced and can be suppressed by low-dose aspirin in PV, thus providing a rationale for assessing the efficacy and safety of a low-dose aspirin regimen in these patients. The Gruppo Italiano Studio Policitemia Vera has recently performed a pilot study on 112 patients randomized to receive aspirin, 40 mg daily, or placebo and followed for 16 +/- 6 months (mean +/- SD). This study showed that low-dose aspirin is well tolerated in PV patients, and that a large-scale efficacy trial is feasible in this setting. In this article we report the protocol of the European Collaboration on Low-dose Aspirin in Polycythemia Vera (ECLAP) study, which is a randomized trial designed to assess the risk/benefit ratio of low-dose aspirin in PV. To estimate the size and the follow-up duration required for the ECLAP trial, a retrospective analysis of the clinical epidemiology of a large PV population has recently been completed by the Gruppo Italiano Studio Policitemia Vera. On this basis, approximately 3500 patients will be enrolled in the ECLAP study with a follow-up of 3 to 4 years. The uncertainty principle will be used as the main eligibility criterion: Polycythemic patients of any age, having no clear indication for or contraindication to aspirin treatment, will be randomized in a double-blind fashion to receive oral aspirin (100 mg daily) or placebo. According to current therapeutic recommendations, the basic treatment of randomized patients should be aimed at maintaining the hematocrit value < or = 45% in subjects aged < or = 50, and hematocrit < 45% as well as platelet count < 400 x 10(9)/L in patients aged > 50. Randomization will be stratified by participating center. The study is funded by the European Union BIOMED 2 program.

Climate Local Information over the Mediterranean to Respond User Needs

NASA Astrophysics Data System (ADS)

Ruti, P.

2012-12-01

CLIM-RUN aims at developing a protocol for applying new methodologies and improved modeling and downscaling tools for the provision of adequate climate information at regional to local scale that is relevant to and usable by different sectors of society (policymakers, industry, cities, etc.). Differently from current approaches, CLIM-RUN will develop a bottom-up protocol directly involving stakeholders early in the process with the aim of identifying well defined needs at the regional to local scale. The improved modeling and downscaling tools will then be used to optimally respond to these specific needs. The protocol is assessed by application to relevant case studies involving interdependent sectors, primarily tourism and energy, and natural hazards (wild fires) for representative target areas (mountainous regions, coastal areas, islands). The region of interest for the project is the Greater Mediterranean area, which is particularly important for two reasons. First, the Mediterranean is a recognized climate change hot-spot, i.e. a region particularly sensitive and vulnerable to global warming. Second, while a number of countries in Central and Northern Europe have already in place well developed climate service networks (e.g. the United Kingdom and Germany), no such network is available in the Mediterranean. CLIM-RUN is thus also intended to provide the seed for the formation of a Mediterranean basin-side climate service network which would eventually converge into a pan-European network. The general time horizon of interest for the project is the future period 2010-2050, a time horizon that encompasses the contributions of both inter-decadal variability and greenhouse-forced climate change. In particular, this time horizon places CLIM-RUN within the context of a new emerging area of research, that of decadal prediction, which will provide a strong potential for novel research.

Comparison of neonatal MRI examinations with and without an MR-compatible incubator: advantages in examination feasibility and clinical decision-making.

PubMed

Rona, Z; Klebermass, K; Cardona, F; Czaba, C D; Brugger, P C; Weninger, M; Pollak, A; Prayer, D

2010-09-01

To assess the utility of an MRI-compatible incubator (INC) by comparing. In a retrospective study, the clinical and radiological aspects of 129 neonatal MRI examinations during a 3 year period were analyzed. Routine protocols including fast spin-echo T2-weighted (w) sequences, axial T1w, Gradient-echo, diffusion sequences, and 3D T1 gradient-echo sequences were performed routinely, angiography and spectroscopy were added in some cases. Diffusion-tensor imaging was done in 50% of the babies examined in the INC and 26% without INC. Sequences, adapted from fetal MR-protocols were done in infants younger than 32 gestational weeks. Benefit from MR-information with respect to further management was evaluated. The number of the examinations increased (30-99), while the mean age (43-38, 8 weeks of gestational age) and weight (3308-2766 g) decreased significantly with the use of the MR-compatible incubator. The mean imaging time (34, 43-30, 29 min) decreased, with a mean of one additionally performed sequence in the INC group. All infants received sedatives according to our anaesthetic protocol preceding imaging, but a repeated dose was never necessary (10% without INC) using the INC. Regarding all cases, MR-based changes in clinical management were initiated in 58%, while in 57% of cases the initial ultrasound diagnosis was changed or further specified. The use of the INC enables the MR access of unstable infants with suspect CNS problems to the management, of whom is improved by MR information to significantly higher percentage, than without INC. Copyright (c) 2010 European Paediatric Neurology Society. Published by Elsevier Ltd. All rights reserved.

Ethnic differences in resting metabolic rate, respiratory quotient and body temperature: a comparison of Africans and European Australians.

PubMed

Adzika Nsatimba, P A; Pathak, K; Soares, M J

2016-08-01

A comparison of resting metabolic rate (RMR), respiratory quotient (RQ) and body temperature between adults of African and European descent. Twenty-nine sub-Saharan Africans (SSA; 13 men and 16 women) and thirty-two Australians of European descent (EUR; eight men and 24 women) had RMR and RQ measured by indirect calorimetry. Dual-energy X-ray absorptiometry was used to determine fat mass (FM), fat-free mass, bone mineral content (BMC), appendicular lean tissue mass and non-appendicular lean tissue mass. Total skeletal muscle mass (SMM) was predicted. Residual mass (RM) was the difference between body weight and the sum of FM, SMM and BMC. The short form of the International Physical Activity Questionnaire was used to determine habitual physical activity (PA). Tympanic in the ear temperature (IET) and forearm to fingertip temperature gradients (FFG) were monitored throughout the protocol. The unadjusted RMR of SSA was significantly lower compared to EUR. Adjusted for age, sex, season, PA, FM, BMC, SMM and RM, this difference in RMR was still evident (mean ± SE, SSA: 4880 ± 161 kJ/d vs. EUR: 5979 ± 111, P < 0.005). The same model of adjustment also uncovered a significantly lower adjusted IET (SSA: 35.26 °C ± 0.133 vs. EUR: 35.60 ± 0.091, P < 0.05), a higher adjusted RQ (SSA: 0.86 ± 0.014 vs. EUR: 0.83 ± 0.010, P < 0.05) but no difference in adjusted FFG. In this study, SSA had a lower RMR, higher RQ and lower IET relative to EUR Australians.

Genome-Wide Association Analysis Reveals Genetic Heterogeneity of Sjögren’s Syndrome According to Ancestry

PubMed Central

Taylor, Kimberly E.; Wong, Quenna; Levine, David M.; McHugh, Caitlin; Laurie, Cathy; Doheny, Kimberly; Lam, Mi Y.; Baer, Alan N.; Challacombe, Stephen; Lanfranchi, Hector; Schiødt, Morten; Srinivasan, M.; Umehara, Hisanori; Vivino, Frederick B.; Zhao, Yan; Shiboski, Stephen; Daniels, Troy E.; Greenspan, John S.; Shiboski, Caroline H.; Criswell, Lindsey A.

2017-01-01

Objective Sjögren's Syndrome (SS) is a systemic autoimmune disease affecting primarily the lacrimal and salivary glands. The Sjögren's International Collaborative Clinical Alliance (SICCA) is an international multisite observational study whose participants have been genotyped on the Omni 2.5M platform and undergone deep phenotyping using common protocol-directed methods, providing a unique opportunity to examine the genetic etiology of SS across ancestry and disease subsets. Methods We perform GWAS analyses utilizing dbGaP controls on all subjects (1405 cases, 1622 SICCA controls, 3125 external controls), European (similarly 585, 966, 2580), and Asian (similarly 460, 224, 901) with ancestry adjustments via principal component analyses. We also investigate whether subphenotype distributions differ by ethnicity and if this contributes to heterogeneity of genetic associations. Results We see significant associations in established regions of the MHC, IRF5, and STAT4 (p=3e-42, p=3e-14, p=9e-10, respectively), and several suggestive novel regions (2 or more associations with p<1e-5). Two regions have been previously implicated in autoimmune disease: KLRG1 (p=6e-7, Asian) and SH2D2A (p=2e-6, all). We observe striking differences between the European and Asian associations, with high heterogeneity especially in the MHC; representative SNPs from established and suggestive regions have highly significant differences in population allele frequencies. We show that SSA/SSB autoantibody production and labial salivary gland Focus Score criteria are associated with higher non-European ancestry (p=4e-15, 4e-5, respectively), but that subphenotype differences do not explain most of the ancestry differences in genetic associations. Conclusion Genetic associations with SS differ markedly by ancestry, however this is not explained by differences in subphenotypes. PMID:28076899

The Assessment of African Swine Fever Virus Risk to Belgium Early 2014, using the Quick and Semiquantitative Pandora Screening Protocol.

PubMed

Roelandt, S; Van der Stede, Y; D'hondt, B; Koenen, F

2017-02-01

A risk assessment was organized during the early EU ASF outbreaks of early 2014 (February-April) and performed in cooperation with 15 Belgian and European experts on ASFV and its epidemiology in pigs/wild boar. African swine fever (ASF) is considered as one of the most dangerous infectious pig diseases, causing many outbreaks. Since the end of 2013 - early 2014, several outbreaks within the European Union (Lithuania, Poland, Estonia and Latvia) were reported to OIE, which prompted several risk assessments by (inter)national bodies and scientists. In this study, the open source, semiquantitative Pandora risk assessment tool was used for a quick overall screening of the risk posed by ASF to Belgium early 2014. A set of integrated risk scores was calculated within the Pandora framework. Experts scored the questions and uncertainty levels in the Pandora modules individually, after which the calculations were performed and averaged scores were used within pre-defined risk scales to define and visualize the ASF risk to Belgium. Emergence risk was considered low (Pandora score 0.29), while disease consequences were deemed high (0.93); the resulting multiplicative overall risk of ASFV for Belgium was low (0.27). The Belgian experts tended to give lower risk scores than the European experts, especially for entry risk and trade/public opinion consequences. These risk scores are further interpreted with a due consideration of the qualitative data in the expert remarks and of other ASF risk assessments. The results are similar to more extensive and elaborate risk assessment models/procedures which may require more time and resources. The Pandora tool allows sequential updates to monitor (rates of) increasing risk and provides information for risk managers to organize targeted control. © 2015 Blackwell Verlag GmbH.

Which should be the essential components of stroke centers in Japan? A survey by questionnaires sent to the directors of facilities certified by the Japan stroke society.

PubMed

Uehara, Toshiyuki; Yasui, Nobuyuki; Okada, Yasushi; Hasegawa, Yasuhiro; Nagatsuka, Kazuyuki; Minematsu, Kazuo

2014-01-01

We conducted a survey by questionnaire to identify the essential components of stroke centers in Japan and compared our results with the European Expert Survey. In 2007, a questionnaire was mailed to the directors of 740 facilities certified by the Japan Stroke Society to ask their opinion on the essential components of comprehensive stroke centers (CSC), primary stroke centers (PSC) and any hospital ward (AHW) admitting acute stroke patients. The directors were asked to provide 1 of the following 6 possible answers regarding 112 components: 'irrelevant'; 'useful but not necessary'; 'desirable'; 'important but not absolutely necessary'; 'absolutely necessary', or 'question unclear or ambiguous'. The components considered 'absolutely necessary' by more than 75% of the respondents were compared between our survey and the European Expert Survey. In addition, we compared the rates of neurosurgeons and neurologists who answered 'absolutely necessary' with regard to each component. Responses were obtained from 428 directors (57.8% response rate). Among these respondents, 298 (69.6%) were neurosurgeons. There was no component considered 'absolutely necessary' for AHW by more than 75% of the respondents, and this was similar to the results of the European Expert Survey. The following components were considered 'absolutely necessary' for PSC in our survey: brain CT scanning 24 h a day, 7 days a week (24/7); automated monitoring of the ECG, pulse oximetry, blood pressure and breathing, and respiratory support. In both our survey and the European Expert Survey, the essential components for CSC were as follows: physiotherapist; brain CT scanning 24/7; monitoring of the ECG, pulse oximetry and blood pressure; carotid surgery; angioplasty and stenting, and intravenous recombinant tissue plasminogen activator protocols. The components multidisciplinary stroke team, stroke-trained nurse, ultrasonography, collaboration with an outside rehabilitation center, stroke pathway and clinical research were deemed essential only in the European Expert Survey. However, MRI 24/7, MR angiography 24/7, conventional angiography 24/7, respiratory support as well as most neuroendovascular and neurosurgical treatments were considered necessary for CSC by more than 75% of the respondents in our survey. Analyzing the responses from only neurologists reduced the differences between our survey and the European Expert Survey. The present study indicated the essential components expected for stroke centers in Japan. Our survey demonstrated that more emphasis was likely to be placed on installations than on a dedicated stroke team and the use of stroke care maps. In addition, the results of this study may reflect some characteristics of the stroke care environment in Japan, such as the predominance of neurosurgeons and widespread use of MRI. © 2014 S. Karger AG, Basel.

Using EMBL-EBI Services via Web Interface and Programmatically via Web Services.

PubMed

Lopez, Rodrigo; Cowley, Andrew; Li, Weizhong; McWilliam, Hamish

2014-12-12

The European Bioinformatics Institute (EMBL-EBI) provides access to a wide range of databases and analysis tools that are of key importance in bioinformatics. As well as providing Web interfaces to these resources, Web Services are available using SOAP and REST protocols that enable programmatic access to our resources and allow their integration into other applications and analytical workflows. This unit describes the various options available to a typical researcher or bioinformatician who wishes to use our resources via Web interface or programmatically via a range of programming languages. Copyright © 2014 John Wiley & Sons, Inc.

Conflict of interest in biomedical research: a view from Europe.

PubMed

Salvi, Maurizio

2003-01-01

In this paper I address the conflict of interest (CoI) issue from a legal point of view at a European level. We will see that the regulatory framework that exists in Europe does state the need for the independence of ethics committee involved in authorisation of research and clinical trials. We will see that CoI is an element that has to be closely monitored at National and International level. Therefore, Member States and Newly Associated States do have to address CoI in the authorisation process of research and clinical protocols of biomedicine.

New generation of telemetry systems using CCSDS packetisation - A prototype implementation

NASA Astrophysics Data System (ADS)

Sotta, J. P.; Held, K.

1988-07-01

The system described herein was developed under ESA contract to support the introduction of new telemetry standards based on the packetized telemetry data concept. These standards were derived from recommendations in the frame of work of CCSDS, an inter-Agency committee that counts among its members most European National Agencies, ESA, NASA as well as Japanese NASDA, Indian ISRO and Brazilian INPE and having as objective to facilitate cross-support for space missions. The development is based on the present generation of ESA on-board equipment (OBDH) subsystem and is fully compatible with OBDH bus interfaces and transfer protocol.

The visualisation and communication of probabilistic climate forecasts to renewable energy policy makers

NASA Astrophysics Data System (ADS)

Doblas-Reyes, F.; Steffen, S.; Lowe, R.; Davis, M.; Rodó, X.

2013-12-01

Despite the strong dependence of weather and climate variability on the renewable energy industry, and several initiatives towards demonstrating the added benefits of integrating probabilistic forecasts into energy decision making process, they are still under-utilised within the sector. Improved communication is fundamental to stimulate the use of climate forecast information within decision-making processes, in order to adapt to a highly climate dependent renewable energy industry. This paper focuses on improving the visualisation of climate forecast information, paying special attention to seasonal to decadal (s2d) timescales. This is central to enhance climate services for renewable energy, and optimise the usefulness and usability of inherently complex climate information. In the realm of the Global Framework for Climate Services (GFCS) initiative, and subsequent European projects: Seasonal-to-Decadal Climate Prediction for the Improvement of European Climate Service (SPECS) and the European Provision of Regional Impacts Assessment in Seasonal and Decadal Timescales (EUPORIAS), this paper investigates the visualisation and communication of s2d forecasts with regards to their usefulness and usability, to enable the development of a European climate service. The target end user will be renewable energy policy makers, who are central to enhance climate services for the energy industry. The overall objective is to promote the wide-range dissemination and exchange of actionable climate information based on s2d forecasts from Global Producing Centres (GPC's). Therefore, it is crucial to examine the existing main barriers and deficits. Examples of probabilistic climate forecasts from different GPC's were used to prepare a catalogue of current approaches, to assess their advantages and limitations and finally to recommend better alternatives. In parallel, interviews were conducted with renewable energy stakeholders to receive feedback for the improvement of existing visualisation techniques of forecasts. The overall aim is to establish a communication protocol for the visualisation of probabilistic climate forecasts, which does not currently exist. Global Producing Centres show their own probabilistic forecasts with limited consistency in their communication across different centres, which complicates the understanding for the end user. A communication protocol for both the visualisation and description of climate forecasts can help to introduce a standard format and message to end users from several climate-sensitive sectors, such as energy, tourism, agriculture and health. It is hoped that this work will facilitate the improvement of decision-making processes relying on forecast information and enable their wide-range dissemination based on a standardised approach.

The development and evaluation of water-mist fire extinguishing systems

NASA Astrophysics Data System (ADS)

Beason, D. G.; Staggs, K. J.

1994-08-01

Fire protection for underfloor space is primarily provided by Halon 1301 which has proven to be very effective. However, due to the link between halons and the possible depletion of the stratospheric ozone layer, plans have been implemented to eventually phase out Halon 1301 and 1211. In September 1987 the Montreal Protocol concerning chlorofluorocarbons (CFC) and halons was signed by the United States, the European Economic Community, and 23 other nations. The Montreal Protocol calls for freezing halon production at 1986 levels. Because the majority of underfloor fire protection at Lawrence Livermore National Laboratory (LLNL), as well as other Department of Energy (DOE) sites, is either Halon 1301 or sprinklers, some other means of suppression will have to be developed and verified. The potential loss to facilities housing computer or control rooms damaged by underfloor fires can be extreme. These losses would not only include hardware and software replacement costs, but also lost computing and control capability. Here at LLNL technical research in a facility could be severely affected. Recent studies conducted by the Fire Research Discipline of the Special Projects Division have shown that severe fires fueled by cable insulation can develop within as little as a 6-in-high underfloor space (even with mechanical ventilation shut off). Studies also show that conventional sprinklers may not be effective in preventing this destruction. Therefore, we are investigating the water-mist fire extinguishing system as an alternative to Halon 1301 and sprinklers.

Quality of life and toxicity in breast cancer patients using adjuvant TAC (docetaxel, doxorubicin, cyclophosphamide), in comparison with FAC (doxorubicin, cyclophosphamide, 5-fluorouracil).

PubMed

Hatam, N; Ahmadloo, N; Ahmad Kia Daliri, A; Bastani, P; Askarian, M

2011-07-01

The aim of this study was to compare two regimens of chemotherapy in patients with breast cancer, including FAC (doxorubicin, cyclophosphamide, and 5-fluorouracil) and TAC (docetaxel, doxorubicin and cyclophosphamide); and analyze the toxicity of these treatments and observe patient's health-related quality of life. Health-related quality of life was assessed for up to 4 months (from the beginning to the end of chemotherapy cycles), using European organization and cancer treatment quality of life questionnaire (EORTC) QLQ-C30. A group of 100 patients, with node-positive breast cancer were studied in order to compare the toxicity of adjuvant therapy TAC with FAC and the subsequent effects on the patient's quality of life. After a 4-month follow-up of patients, our findings showed that despite having the same mean score of QOL at the start of adjuvant chemotherapy, the QOL in TAC arm was decreased more as a result of the higher range of toxicity in TAC regimen. In spite of increase in disease-free patients who received TAC regimen and increase their survival rate, there is significant toxicity and decrease in QOL in TAC protocol compare to FAC protocol. Using prophylactic granulocyte colony stimulating factor (G-CSF) along with increased education aimed at improving patient's knowledge and also the provision of a supportive group involving psychiatrics and patients that have successfully experienced the same treatment may be helpful.

Students’ Factors Affecting Undergraduates’ Perceptions of their Teaching and Learning Process within ECTS Experience

PubMed Central

la Fuente, Jesús De; Cardelle-Elawar, María; Peralta, F. Javier; Sánchez, M. Dolores; Martínez-Vicente, José Manuel; Zapata, Lucía

2010-01-01

Introduction: In the present study, we investigated the potential factors that influenced the level of students satisfaction with the teaching–learning process (TLP), from the perspective of students participating in the European Credit Transfer System (ECTS) experience. Method: A total of 1490 students from the Universities of Almería and Granada (Spain) participated in an evaluation of their class discipline area. They completed the new revised protocol for evaluating the ECTS experience. Analyses of variance were carried out, taking the following factors as independent variables: student's grade average, year in school, study discipline, credit load in terms of ECTS credits assigned to a subject, the e-learning approach. Perception of the TLP was used as the dependent variable. Results: The data analyses showed variability of the degree of statistically significance among the factors that influenced students’ perceptions of the TLP. These factors included: Student's grade average (in favor of high performers), year in school (in favor of earlier years), ECTS load (in favor of subjects with a medium load of credits), and e-learning (in favor of its use). These research findings provided evidence to explore the delineation of a potential profile of factors that trigger a favorable perception of the TLP. Discussion and Conclusion: The present findings certainly have implications to deepen our understanding of the core beliefs, commitment, and the experience in shaping the implementation of the European Higher Education Area through the ECTS. PMID:21713171

Good practices and challenges in addressing poliomyelitis and measles in the European Union.

PubMed

Kinsman, John; Stöven, Svenja; Elgh, Fredrik; Murillo, Pilar; Sulzner, Michael

2018-04-06

All European Union (EU) and European Economic Area (EEA) Member States have pledged to ensure political commitment towards sustaining the region's poliomyelitis-free status and eliminating measles. However, there remain significant gaps between policy and practice in many countries. This article reports on an assessment conducted for the European Commission that aimed to support improvements in preparedness and response to poliomyelitis and measles in Europe. A documentary review was complemented by qualitative interviews with professionals working in International and EU agencies, and in at-risk or recently affected EU/EEA Member States (six each for poliomyelitis and measles). Twenty-six interviews were conducted on poliomyelitis and 24 on measles; the data were subjected to thematic analysis. Preliminary findings were then discussed at a Consensus Workshop with 22 of the interviewees and eight other experts. Generic or disease-specific plans exist in the participating countries and cross-border communications during outbreaks were generally reported as satisfactory. However, surveillance systems are of uneven quality, and clinical expertise for the two diseases is limited by a lack of experience. Serious breaches of protocol have recently been reported from companies producing poliomyelitis vaccines, and vaccine coverage rates for both diseases were also sub-optimal. A set of suggested good practices to address these and other challenges is presented. Poliomyelitis and measles should be brought fully onto the policy agendas of all EU/EEA Member States, and adequate resources provided to address them. Each country must abide by the relevant commitments that they have already made.

Clinical efficacy of implementing Bio Immune(G)ene MEDicine in the treatment of chronic asthma with the objective of reducing or removing effectively corticosteroid therapy: A novel approach and promising results.

PubMed

Glady, Gilbert

2018-06-01

Asthma is one of the diseases that demonstrates a wide range of variation in its clinical expression, in addition to an important heterogeneity in the pathophysiological mechanisms present in each case. The ever-increasing knowledge of the molecular signalling routes and the development of the Bio Immune(G)ene Medicine [BI(G)MED] therapy in line with this knowledge has revealed a whole novel potential set of self-regulation biological molecules, that may be used to promote the physiological immunogenic self-regulation mechanisms and re-establish the homeostatic balance at a genomic, proteomic and cellular level. The aim of the present study is to demonstrate that the sublingual use of a therapeutic protocol based on BI(G)MED regulatory BIMUREGs in the treatment of chronic asthma may reduce or suppress corticosteroid therapy and avoid its harmful side effects which some patients suffer when using this treatment on a long-term basis. The clinical efficacy of BI(G)MED for chronic asthma was evaluated through a multi-centre study carried out in 2016 implementing a 6-month BI(G)MED treatment protocol for Bronchial Asthma. A total of 61 patients from private medical centres and of European countries including Germany, Austria, France, Belgium and Spain participated. The manuscript describes in detail the clinical efficacy of Bio Immune(G)ene regulatory BI(G)MED treatment protocol that allows the reduction or total removal of the corticosteroid dose in patients with chronic asthma. No adverse reactions were observed. The BI(G)MED regulatory therapy brings novel therapeutic possibilities as an effective and safe treatment of chronic asthma. BI(G)MED was demonstrated to significantly reduce asthma severity when parameter compositions were all analysed by categorical outcomes. Therefore, it is considered a good therapeutic alternative for patients who respond poorly to steroids.

Pediatric allergy and immunology in Italy.

PubMed

Tozzi, Alberto E; Armenio, Lucio; Bernardini, Roberto; Boner, Attilio; Calvani, Mauro; Cardinale, Fabio; Cavagni, Giovanni; Dondi, Arianna; Duse, Marzia; Fiocchi, Alessandro; Marseglia, Gian L; del Giudice, Michele Miraglia; Muraro, Antonella; Pajno, Giovanni B; Paravati, Francesco; Peroni, Diego; Tripodi, Salvatore; Ugazio, Alberto G; Indinnimeo, Luciana

2011-05-01

In Italy, according to the International Study on Asthma and Allergies in Childhood study, the prevalence of current asthma, allergic rhinoconjunctivitis, and atopic eczema in 2006 was 7.9%, 6.5%, and 10.1% among children aged 6-7 and 8.4%, 15.5%, and 7.75% among children aged 13-14 yr. University education in this field is provided by the Postgraduate Schools of Pediatrics and those of Allergology and Clinical Immunology, as well as several annual Master courses. The Italian Society of Pediatric Allergology and Immunology (SIAIP) was founded in 1996 and counts about 1000 members. SIAIP promotes evidence-based management of allergic children and disseminates information to patients and their families through a quite innovative website and the National Journal 'Rivista Italiana di Allergologia Pediatrica'. In the last decade, four major regional, inter-regional, and national web-based networks have been created to link pediatric allergy centers and to share their clinical protocols and epidemiologic data. In addition, National Registers of Primary Immune-deficiencies and on Pediatric HIV link all clinical excellence centers. Research projects in the field of pediatric allergy and immunology are founded by the Italian Ministry of Education, University and Research (MIUR) and by the National Research Council (CNR), but the overall investments in this research area are quite low. Only a handful Italian excellence centers participate in European Projects on Pediatric Allergy and Immunology within the 7th Framework Program. The European Academy of Allergy and Clinical Immunology currently hosts two Italians in its Executive Committee (EC) and one in the EC of the Pediatric Section; moreover, major European Academy of Allergy and Clinical Immunology meetings and courses in the area of pediatrics (e.g., PAAM, Venice, 2009) have been held in Italy in the last 3 yr. Italian hallmarks in the management of allergic diseases in childhood are a quite alive and spread interest in Molecular Allergology and a remarkable predominance of sublingual (SLIT) compared to the subcutaneous (SCIT) immunotherapy. © 2011 John Wiley & Sons A/S.

European emissions of HCFC-22 based on eleven years of high frequency atmospheric measurements and a Bayesian inversion method

NASA Astrophysics Data System (ADS)

Graziosi, F.; Arduini, J.; Furlani, F.; Giostra, U.; Kuijpers, L. J. M.; Montzka, S. A.; Miller, B. R.; O'Doherty, S. J.; Stohl, A.; Bonasoni, P.; Maione, M.

2015-07-01

HCFC-22 (CHClF2), a stratospheric ozone depleting substance and a powerful greenhouse gas, is the third most abundant anthropogenic halocarbon in the atmosphere. Primarily used in refrigeration and air conditioning systems, its global production and consumption have increased during the last 60 years, with the global increases in the last decade mainly attributable to developing countries. In 2007, an adjustment to the Montreal Protocol for Substances that Deplete the Ozone Layer called for an accelerated phase out of HCFCs, implying a 75% reduction (base year 1989) of HCFC production and consumption by 2010 in developed countries against the previous 65% reduction. In Europe HCFC-22 is continuously monitored at the two sites Mace Head (Ireland) and Monte Cimone (Italy). Combining atmospheric observations with a Bayesian inversion technique, we estimated fluxes of HCFC-22 from Europe and from eight macro-areas within it, over an 11-year period from January 2002 to December 2012, during which the accelerated restrictions on HCFCs production and consumption have entered into force. According to our study, the maximum emissions over the entire domain was in 2003 (38.2 ± 4.7 Gg yr-1), and the minimum in 2012 (12.1 ± 2.0 Gg yr-1); emissions continuously decreased between these years, except for secondary maxima in the 2008 and 2010. Despite such a decrease in regional emissions, background values of HCFC-22 measured at the two European stations over 2002-2012 are still increasing as a consequence of global emissions, in part from developing countries, with an average trend of ca 7.0 ppt yr-1. However, the observations at the two European stations show also that since 2008 a decrease in the global growth rate has occurred. In general, our European emission estimates are in good agreement with those reported by previous studies that used different techniques. Since the currently dominant emission source of HCFC-22 is from banks, we assess the banks' size and their contribution to the total European emissions up to 2030, and we project a fast decrease approaching negligible emissions in the last five years of the considered period. Finally, inversions conducted over three month periods showed evidence for a seasonal cycle in emissions in regions in the Mediterranean basin but not outside it. Emissions derived from regions in the Mediterranean basin were ca. 25% higher in warmer months than in colder months.

Validation of the HONSUN LD-578 blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol.

PubMed

Zhang, Yi; Wang, Jie; Huang, Qi-Fang; Sheng, Chang-Sheng; Li, Yan; Wang, Ji-Guang

2009-06-01

This study aimed to evaluate the accuracy of the automated oscillometric upper arm blood pressure monitor LD-578 (HONSUN Group, Shanghai, China) for home blood pressure monitoring according to the International Protocol. Systolic and diastolic blood pressures were sequentially measured in 33 adult Chinese using a mercury sphygmomanometer (two observers) and the LD-578 device (one supervisor). Ninety-nine pairs of comparisons were obtained from 15 participants in phase 1 and a further 18 participants in phase 2 of the validation study. Data analysis was performed using the ESHIP Analyzer. The LD-578 device successfully passed phase 1 of the validation study with a number of absolute differences between device and observers within 5, 10, and 15 mmHg for at least 32 of 45, 41 of 45, and 45 of 45 measurements (required 25, 35, and 40), respectively. The device also achieved the targets for phase 2.1, with 67 of 99, 90 of 99, and 98 of 99 differences within 5, 10, and 15 mmHg, respectively, for systolic blood pressure, and with 69 of 99, 95 of 99, and 98 of 99 within 5, 10, and 15 mmHg, respectively, for diastolic blood pressure. In phase 2.2, 24 participants had at least two of the three device-observers differences within 5 mmHg (required >or=22) for systolic and diastolic blood pressure. The HONSUN upper arm blood pressure monitor LD-578 can be recommended for home use in adults.

Regional fat distribution in adolescent and adult females with anorexia nervosa: A longitudinal study.

PubMed

El Ghoch, Marwan; Milanese, Chiara; Calugi, Simona; Müller, Manfred J; Pourhassan, Maryam; Ruocco, Antonella; Dalle Grave, Riccardo

2015-12-01

No study has yet compared body fat distribution before and after weight restoration in adolescent and adult patients with anorexia nervosa (AN) treated according to the same protocol. The study was set up to measure body fat distribution before and after short-term weight restoration in adolescent and adult patients with AN treated according to the same protocol in a specialist inpatient unit. We recruited 33 consecutive adolescent female patients with AN, and 33 controls matched by age and post-treatment BMI centile, as well as 33 adult female patients with AN, and 33 controls matched by age and post-treatment BMI. Dual-energy X-ray absorptiometry (DXA) was used to assess body composition before and after short-term weight restoration (BMI ≥ 18.5 kg/m²). Compared with controls, both adolescents and adults with AN showed that a greater amount of fat was lost from the extremities than the trunk before weight restoration, and that there was a central adiposity phenotype after short-term weight restoration. There were no significant differences in body fat distribution between adolescents and adults with AN before or after short-term weight restoration. Adolescent and adult females with AN have similar body fat distribution both before and after short-term weight restoration, and show a central adiposity phenotype after short-term weight restoration. The clinical implications of this finding are as yet unknown. Clinical Trials Registry- Regional Fat Distribution in Adolescent Girls and Adults with Anorexia Nervosa (ISRCTN73572502). Copyright © 2014 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

Prevalence of Nutrition and Health-Related Claims on Pre-Packaged Foods: A Five-Country Study in Europe.

PubMed

Hieke, Sophie; Kuljanic, Nera; Pravst, Igor; Miklavec, Krista; Kaur, Asha; Brown, Kerry A; Egan, Bernadette M; Pfeifer, Katja; Gracia, Azucena; Rayner, Mike

2016-03-03

This study is part of the research undertaken in the EU funded project CLYMBOL ("Role of health-related CLaims and sYMBOLs in consumer behaviour"). The first phase of this project consisted of mapping the prevalence of symbolic and non-symbolic nutrition and health-related claims (NHC) on foods and non-alcoholic beverages in five European countries. Pre-packaged foods and drinks were sampled based on a standardized sampling protocol, using store lists or a store floor plan. Data collection took place across five countries, in three types of stores. A total of 2034 foods and drinks were sampled and packaging information was analyzed. At least one claim was identified for 26% (95% CI (24.0%-27.9%)) of all foods and drinks sampled. Six percent of these claims were symbolic. The majority of the claims were nutrition claims (64%), followed by health claims (29%) and health-related ingredient claims (6%). The most common health claims were nutrient and other function claims (47% of all claims), followed by disease risk reduction claims (5%). Eight percent of the health claims were children's development and health claims but these were only observed on less than 1% (0.4%-1.1%) of the foods. The category of foods for specific dietary use had the highest proportion of NHC (70% of foods carried a claim). The prevalence of symbolic and non-symbolic NHC varies across European countries and between different food categories. This study provides baseline data for policy makers and the food industry to monitor and evaluate the use of claims on food packaging.

Social support systems as determinants of self-management and quality of life of people with diabetes across Europe: study protocol for an observational study.

PubMed

Koetsenruijter, Jan; van Lieshout, Jan; Vassilev, Ivaylo; Portillo, Mari Carmen; Serrano, Manuel; Knutsen, Ingrid; Roukova, Poli; Lionis, Christos; Todorova, Elka; Foss, Christina; Rogers, Anne; Wensing, Michel

2014-03-04

Long-term conditions pose major challenges for healthcare systems. Optimizing self-management of people with long-term conditions is an important strategy to improve quality of life, health outcomes, patient experiences in healthcare, and the sustainability of healthcare systems. Much research on self-management focuses on individual competencies, while the social systems of support that facilitate self-management are underexplored. The presented study aims to explore the role of social systems of support for self-management and quality of life, focusing on the social networks of people with diabetes and community organisations that serve them. The protocol concerns a cross-sectional study in 18 geographic areas in six European countries, involving a total of 1800 individuals with diabetes and 900 representatives of community organisations. In each country, we include a deprived rural area, a deprived urban area, and an affluent urban area. Individuals are recruited through healthcare practices in the targeted areas. A patient questionnaire comprises measures for quality of life, self-management behaviours, social network and social support, as well as individual characteristics. A community organisations' survey maps out interconnections between community and voluntary organisations that support patients with chronic illness and documents the scope of work of the different types of organisations. We first explore the structure of social networks of individuals and of community organisations. Then linkages between these social networks, self-management and quality of life will be examined, taking deprivation and other factors into account. This study will provide insight into determinants of self-management and quality of life in individuals with diabetes, focusing on the role of social networks and community organisations.

Health-related quality of life among colorectal cancer patients in Malaysia: a study protocol

PubMed Central

2012-01-01

Background Colorectal cancer is a major public health problem in Malaysia. However, it is also one of the most treatable cancers, resulting in significant numbers of survivors. Therefore, the impact of surviving treatment for colorectal cancer on health related quality of life is important for the patients, clinicians and policy makers, and may differ in different cultures and populations. The aim of this study was to validate the Malaysian versions of the European Organization for Research and Treatment of Cancer quality of life instruments among colorectal cancers patients. Methods/design This is a cross sectional multi centre study. Three hospitals were included, the University of Malaya Medical Centre, the Universiti Kebangsaan Malaysia Medical Centre and Hospital Tuanku Jaafar Seremban. Malaysian citizens and permanent residence were studied and demographic and clinical information obtained from hospital records. The European Organization for Research and Treatment of Cancer Quality of life Core 30, colorectal cancer CR29, and the colorectal cancer liver metastasis LMC 21 were used and an observer assessment of performance obtained with the Karnofsky Performance Scale. Questionnaires were translated into three most commonly spoken languages in Malaysia (Bahasa Malaysia, Chinese and Tamil), then administered, scored and analyzed following the developers’ guidelines. Ethical approval was obtained from the participating centres. Tests of reliability and validity were performed to examine the validity of these instruments. Conclusion The result of pilot testing shows that the use of the Malaysian versions of EORTC QLQ C30, CR29 instruments is feasible in our sample of colorectal cancer patients. Instructions for completion as well as questions were well understood except the questions on the overall quality of life, overall health status and sexual activity. Thus we anticipate obtaining good psychometric properties for the instruments at the end of the study. PMID:22937765

Health-related quality of life among colorectal cancer patients in Malaysia: a study protocol.

PubMed

Magaji, Bello Arkilla; Moy, Foong Ming; Roslani, April Camilla; Sagap, Ismail; Zakaria, Jasiah; Blazeby, Jane M; Law, Chee Wei

2012-09-03

Colorectal cancer is a major public health problem in Malaysia. However, it is also one of the most treatable cancers, resulting in significant numbers of survivors. Therefore, the impact of surviving treatment for colorectal cancer on health related quality of life is important for the patients, clinicians and policy makers, and may differ in different cultures and populations. The aim of this study was to validate the Malaysian versions of the European Organization for Research and Treatment of Cancer quality of life instruments among colorectal cancers patients. This is a cross sectional multi centre study. Three hospitals were included, the University of Malaya Medical Centre, the Universiti Kebangsaan Malaysia Medical Centre and Hospital Tuanku Jaafar Seremban. Malaysian citizens and permanent residence were studied and demographic and clinical information obtained from hospital records. The European Organization for Research and Treatment of Cancer Quality of life Core 30, colorectal cancer CR29, and the colorectal cancer liver metastasis LMC 21 were used and an observer assessment of performance obtained with the Karnofsky Performance Scale. Questionnaires were translated into three most commonly spoken languages in Malaysia (Bahasa Malaysia, Chinese and Tamil), then administered, scored and analyzed following the developers' guidelines. Ethical approval was obtained from the participating centres. Tests of reliability and validity were performed to examine the validity of these instruments. The result of pilot testing shows that the use of the Malaysian versions of EORTC QLQ C30, CR29 instruments is feasible in our sample of colorectal cancer patients. Instructions for completion as well as questions were well understood except the questions on the overall quality of life, overall health status and sexual activity. Thus we anticipate obtaining good psychometric properties for the instruments at the end of the study.

Chinese SLE Treatment and Research group (CSTAR) registry: I. Major clinical characteristics of Chinese patients with systemic lupus erythematosus.

PubMed

Li, M; Zhang, W; Leng, X; Li, Z; Ye, Z; Li, C; Li, X; Zhu, P; Wang, Z; Zheng, Y; Li, X; Zhang, M; Zhang, F; Zhao, Y; Zeng, X

2013-10-01

The Chinese systemic lupus erythematosus (SLE) treatment and research group (CSTAR) provides major clinical characteristics of SLE in China and establishes a platform to provide resources for future basic and clinical studies. CSTAR originated as a multicentre, consecutive, and prospective design. The data were collected online from 104 rheumatology centers, which covered 30 provinces in China. The registered patients were required to meet four or more of the American College of Rheumatology (ACR) criteria for the classification of SLE. All CSTAR centers use the same protocol-directed methods to provide uniform evaluations, which included demographic data, clinical features, laboratory examinations, and disease activity evaluations. The patient samples, including DNA samples and sera, were also collected for further quality controls and additional studies. Preliminary analysis from 2104 baseline evaluations was available for this analysis. Of 1914 female and 190 male patients (F:M=10.1), the mean age at onset was 29.2 y with confirmed diagnosis one year later at the age of 30.3 y. Eighty four (4.2%) of 2002 patients had a family history of rheumatic diseases, including 34 (1.7%) cases with SLE. In addition, one hundred and seven (5.2%) abnormal pregnancies were recorded among 2026 experiences. The characteristics of the CSTAR cohort were compared to similarly sized cohorts from other studies. We found that 56.1% of patients presented with concurrent hematological disorders compared to only 18.2% of European patients. Moreover, 47.4% of patients presented with nephropathy compared to 27.9% of European patients. Conversely, neurological manifestations were only seen in 4.8% of Chinese SLE patients compared to 19.4% of European patients, 12.1% of U.S. patients, 22.8% of Malaysian patients and 26.4% of Latin Americans. Pulmonary arterial hypertension and interstitial lung diseases were complications identified in 3.8% and 4.2% of Chinese lupus patients, respectively. The CSTAR registry has provided epidemiological data and phenotypes of Chinese patients with SLE, and has demonstrated several differences between ethnicities. Clinical data and biologic samples would be valuable resources for future translational studies with national and international collaboration.

A multiplex real-time PCR assay for the identification and differentiation of Salmonella enterica serovar Typhimurium and monophasic serovar 4,[5],12:i:-.

PubMed

Prendergast, Deirdre M; Hand, Darren; Nί Ghallchóir, Eadaoin; McCabe, Evonne; Fanning, Seamus; Griffin, Margaret; Egan, John; Gutierrez, Montserrat

2013-08-16

Salmonella enterica subsp. enterica serovar 4,[5],12:i:- is considered to be a monophasic variant of Salmonella Typhimurium and is increasingly associated with human infections. The use of PCR for the unequivocal identification of strains identified by conventional serotyping as 4,[5],12:i:- has been recommended by the European Food Safety Authority (EFSA), in particular the conventional multiplex PCR developed by Tennant et al. (2010). An alternative protocol for the identification and differentiation of S. Typhimurium and S. Typhimurium-like strains, including its monophasic variants, based on a multiplex real-time PCR assay was developed in our laboratory. A panel of 206 Salmonella strains was used to validate our multiplex real-time PCR against the conventional multiplex PCR recommended by EFSA, i.e. 43 Salmonella strains of serovars other than Typhimurium and 163 routine isolates determined by slide agglutination serotyping to have an incomplete antigenic formula compatible with the S. Typhimurium formula 4,[5],12:i:1,2. Both methods correctly identified the 43 Salmonella strains as non S. Typhimurium. Among the 163 isolates of undetermined serovar by conventional serotyping, both PCR protocols identified 54 isolates as S. Typhimurium, 101 as monophasic S. Typhimurium and 8 as non-S. Typhimurium. Twenty isolates phenotypically lacking the phase-2 H antigen were positive for the fljB.1,2 gene. These strains have been recently described in the literature by other workers and have been referred to as "inconsistent" variants of S. Typhimurium. Antimicrobial resistance and phage typing were also performed on the S. Typhimurium isolates, including monophasic variants, and approximately half of the isolates identified as monophasic S. Typhimurium by our multiplex real-time PCR protocol were DT193 with the resistance pattern ASSuT. There was 100% concordance between the conventional PCR and the multiplex real-time PCR method developed in this study which proved that our protocol is equivalent to the one recommended by EFSA. In comparison to the conventional PCR, this new protocol is faster and is currently being applied routinely in our laboratory to all isolates that could potentially be S. Typhimurium. Copyright © 2013 Elsevier B.V. All rights reserved.

Selective waste collection optimization in Romania and its impact to urban climate

NASA Astrophysics Data System (ADS)

Mihai, Šercǎianu; Iacoboaea, Cristina; Petrescu, Florian; Aldea, Mihaela; Luca, Oana; Gaman, Florian; Parlow, Eberhard

2016-08-01

According to European Directives, transposed in national legislation, the Member States should organize separate collection systems at least for paper, metal, plastic, and glass until 2015. In Romania, since 2011 only 12% of municipal collected waste was recovered, the rest being stored in landfills, although storage is considered the last option in the waste hierarchy. At the same time there was selectively collected only 4% of the municipal waste. Surveys have shown that the Romanian people do not have selective collection bins close to their residencies. The article aims to analyze the current situation in Romania in the field of waste collection and management and to make a proposal for selective collection containers layout, using geographic information systems tools, for a case study in Romania. Route optimization is used based on remote sensing technologies and network analyst protocols. Optimizing selective collection system the greenhouse gases, particles and dust emissions can be reduced.

Environment and economic risk: An analysis of carbon emission market and portfolio management.

PubMed

Luo, Cuicui; Wu, Desheng

2016-08-01

Climate change has been one of the biggest and most controversial environmental issues of our times. It affects the global economy, environment and human health. Many researchers find that carbon dioxide (CO2) has contributed the most to climate change between 1750 and 2005. In this study, the orthogonal GARCH (OGARCH) model is applied to examine the time-varying correlations in European CO2 allowance, crude oil and stock markets in US, Europe and China during the Protocol's first commitment period. The results show that the correlations between EUA carbon spot price and the equity markets are higher and more volatile in US and Europe than in China. Then the optimal portfolios consisting these five time series are selected by Mean-Variance and Mean-CVAR models. It shows that the optimal portfolio selected by MV-OGARCH model has the best performance. Copyright © 2016 Elsevier Inc. All rights reserved.

A personal perspective and update on erosive tooth wear - 10 years on: Part 1 - Diagnosis and prevention.

PubMed

Bartlett, D

2016-08-12

Tooth wear has been recognised as an increasing problem over the past 10 years. Recent data from epidemiological studies indicate that the condition is common with prevalence of dentine exposure in adults ranging between 2% and 10% and visible surface changes on teeth observed up to 30% of European adults. The Basic Erosive Wear Examination (BEWE) was designed for general practitioners to score the severity using similar protocols as the Basic Periodontal Examination (BPE). The role of the BEWE is partly to increase awareness, but also a means to record the severity in the clinical notes. Over the past 10 years toothpaste manufacturers have launched products to prevent progression of erosive tooth wear using specially formulated fluorides or calcium based products. Probably the most important preventive advice is to reduce the frequency of acidic foods and drinks, particularly outside meal times.

Pregnant woman and road safety: experimental crash test with post mortem human subject.

PubMed

Delotte, Jerome; Behr, Michel; Thollon, Lionel; Arnoux, Pierre-Jean; Baque, Patrick; Bongain, Andre; Brunet, Christian

2008-05-01

Trauma affect between 3 and 7% of all pregnancies in industrialized countries, and the leading cause of these traumas is car crashes. The difficulty to appreciate physiologic and anatomic changes occurring during pregnancy explain that majority of studies were not based on anatomical data. We present a protocol to create a realistic anatomical model of pregnant woman using a post mortem human subject (PMHS). We inserted a physical model of the gravid uterus into the pelvis of a PMHS. 3D acceleration sensors were placed on the subject to measure the acceleration on different body segments. We simulated three frontal impact situations at 20 km/h between two average European cars. Two main kinematics events were identified as possible causes of injuries: lap belt loading and backrest impact. Cadaver experiments provide one interesting complementary approach to study injury mechanisms related to road accidents involving pregnant women. This anatomical accuracy makes it possible to progress in the field of safety devices.

21 CFR 58.120 - Protocol.

Code of Federal Regulations, 2010 CFR

2010-04-01

... FOR NONCLINICAL LABORATORY STUDIES Protocol for and Conduct of a Nonclinical Laboratory Study § 58.120 Protocol. (a) Each study shall have an approved written protocol that clearly indicates the objectives and all methods for the conduct of the study. The protocol shall contain, as applicable, the following...

A Validated Method for the Quality Control of Andrographis paniculata Preparations.

PubMed

Karioti, Anastasia; Timoteo, Patricia; Bergonzi, Maria Camilla; Bilia, Anna Rita

2017-10-01

Andrographis paniculata is a herbal drug of Asian traditional medicine largely employed for the treatment of several diseases. Recently, it has been introduced in Europe for the prophylactic and symptomatic treatment of common cold and as an ingredient of dietary supplements. The active principles are diterpenes with andrographolide as the main representative. In the present study, an analytical protocol was developed for the determination of the main constituents in the herb and preparations of A. paniculata . Three different extraction protocols (methanol extraction using a modified Soxhlet procedure, maceration under ultrasonication, and decoction) were tested. Ultrasonication achieved the highest content of analytes. HPLC conditions were optimized in terms of solvent mixtures, time course, and temperature. A reversed phase C18 column eluted with a gradient system consisting of acetonitrile and acidified water and including an isocratic step at 30 °C was used. The HPLC method was validated for linearity, limits of quantitation and detection, repeatability, precision, and accuracy. The overall method was validated for precision and accuracy over at least three different concentration levels. Relative standard deviation was less than 1.13%, whereas recovery was between 95.50% and 97.19%. The method also proved to be suitable for the determination of a large number of commercial samples and was proposed to the European Pharmacopoeia for the quality control of Andrographidis herba. Georg Thieme Verlag KG Stuttgart · New York.

Reproducibility of ECG-gated ultrasound diameter assessment of small abdominal aortic aneurysms.

PubMed

Bredahl, K; Eldrup, N; Meyer, C; Eiberg, J E; Sillesen, H

2013-03-01

No standardised ultrasound procedure to obtain reliable growth estimates for abdominal aortic aneurysms (AAA) is currently available. We investigated the feasibility and reproducibility of a novel approach controlling for a combination of vessel wall delineation and cardiac cycle variation. Prospective comparative study. Consecutive patients (N = 27) with an AAA, attending their 6-month control as part of a medical treatment trial, were scanned twice by two ultrasound operators. Then, all ultrasound recordings were transferred to a core facility and analysed by a third person. The AAA diameter was determined in four different ways: from the leading edge of adventitia on the anterior wall to either the leading edge of the adventitia (method A) or leading edge of the intima (method B) on the posterior wall, with both measurements performed in systole and diastole. Inter-operator reproducibility was ± 3 mm for all methods applied. There was no difference in outcome between methods A and B; likewise, end-diastolic measurement did not improve reproducibility in preference to peak-systolic measurement. The use of a standardised ultrasound protocol including ECG-gating and subsequent off-line reading with minute calliper placement reduces variability. This may be of use in developing protocols to better detect even small AAA growth rates during clinical trials. Copyright © 2012 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.

OC ToGo: bed site image integration into OpenClinica with mobile devices

NASA Astrophysics Data System (ADS)

Haak, Daniel; Gehlen, Johan; Jonas, Stephan; Deserno, Thomas M.

2014-03-01

Imaging and image-based measurements nowadays play an essential role in controlled clinical trials, but electronic data capture (EDC) systems insufficiently support integration of captured images by mobile devices (e.g. smartphones and tablets). The web application OpenClinica has established as one of the world's leading EDC systems and is used to collect, manage and store data of clinical trials in electronic case report forms (eCRFs). In this paper, we present a mobile application for instantaneous integration of images into OpenClinica directly during examination on patient's bed site. The communication between the Android application and OpenClinica is based on the simple object access protocol (SOAP) and representational state transfer (REST) web services for metadata, and secure file transfer protocol (SFTP) for image transfer, respectively. OpenClinica's web services are used to query context information (e.g. existing studies, events and subjects) and to import data into the eCRF, as well as export of eCRF metadata and structural information. A stable image transfer is ensured and progress information (e.g. remaining time) visualized to the user. The workflow is demonstrated for a European multi-center registry, where patients with calciphylaxis disease are included. Our approach improves the EDC workflow, saves time, and reduces costs. Furthermore, data privacy is enhanced, since storage of private health data on the imaging devices becomes obsolete.

A CARD-FISH protocol for the identification and enumeration of cyanobacterial akinetes in lake sediments.

PubMed

Ramm, Jessica; Lupu, Achsa; Hadas, Ora; Ballot, Andreas; Rücker, Jacqueline; Wiedner, Claudia; Sukenik, Assaf

2012-10-01

Akinetes are the dormant cells of Nostocales (cyanobacteria) that enable the organisms to survive harsh environmental conditions while resting in bottom sediments. The germination of akinetes assists the dispersal and persistence of the species. The assessment of the akinete pool in lake sediments is essential to predict the bloom formation of the Nostocales population. We present here the implementation of an improved catalysed reporter deposition (CARD)-fluorescence in situ hybridization (FISH) protocol to assist the identification and quantification of akinetes in sediment samples. Several 16S rRNA gene oligonucleotide probes were evaluated for labelling akinetes of various species of Anabaena, Aphanizomenon and Cylindrospermopsis. Akinetes of all the taxa studied were successfully labelled and could be easily detected by their bright fluorescence signal. The probes' specificity was tested with 32 strains of different taxa. All six Cylindrospermopsis raciborskii strains were labelled with a specific probe for its 16S rRNA gene. A more general probe labelled 73% of the Anabaena and Aphanizomenon strains. The counting data of field samples obtained with CARD-FISH and the regular light microscopy approach did not differ significantly, confirming the suitability of both methods. The CARD-FISH approach was found to be less time-consuming because of better visibility of akinetes. © 2012 Federation of European Microbiological Societies. Published by Blackwell Publishing Ltd. All rights reserved.

Desensitization in delayed drug hypersensitivity reactions -- an EAACI position paper of the Drug Allergy Interest Group.

PubMed

Scherer, K; Brockow, K; Aberer, W; Gooi, J H C; Demoly, P; Romano, A; Schnyder, B; Whitaker, P; Cernadas, J S R; Bircher, A J

2013-07-01

Drug hypersensitivity may deprive patients of drug therapy, and occasionally no effective alternative treatment is available. Successful desensitization has been well documented in delayed drug hypersensitivity reactions. In certain situations, such as sulfonamide hypersensitivity in HIV-positive patients or hypersensitivity to antibiotics in patients with cystic fibrosis, published success rates reach 80%, and this procedure appears helpful for the patient management. A state of clinical tolerance may be achieved by the administration of increasing doses of the previously offending drug. However, in most cases, a pre-existent sensitization has not been proven by positive skin tests. Successful re-administration may have occurred in nonsensitized patients. A better understanding of the underlying mechanisms of desensitization is needed. Currently, desensitization in delayed hypersensitivity reactions is restricted to mild, uncomplicated exanthems and fixed drug eruptions. The published success rates vary depending on clinical manifestations, drugs, and applied protocols. Slower protocols tend to be more effective than rush protocols; however, underreporting of unsuccessful procedures is very probable. The decision to desensitize a patient must always be made on an individual basis, balancing risks and benefits. This paper reviews the literature and presents the expert experience of the Drug Hypersensitivity Interest Group of the European Academy of Allergy and Clinical Immunology. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Clinical-grade generation of peptide-stimulated CMV/EBV-specific T cells from G-CSF mobilized stem cell grafts.

PubMed

Gary, Regina; Aigner, Michael; Moi, Stephanie; Schaffer, Stefanie; Gottmann, Anja; Maas, Stefanie; Zimmermann, Robert; Zingsem, Jürgen; Strobel, Julian; Mackensen, Andreas; Mautner, Josef; Moosmann, Andreas; Gerbitz, Armin

2018-05-09

A major complication after allogeneic hematopoietic stem cell transplantation (aSCT) is the reactivation of herpesviruses such as cytomegalovirus (CMV) and Epstein-Barr virus (EBV). Both viruses cause significant mortality and compromise quality of life after aSCT. Preventive transfer of virus-specific T cells can suppress reactivation by re-establishing functional antiviral immune responses in immunocompromised hosts. We have developed a good manufacturing practice protocol to generate CMV/EBV-peptide-stimulated T cells from leukapheresis products of G-CSF mobilized and non-mobilized donors. Our procedure selectively expands virus-specific CD8+ und CD4+ T cells over 9 days using a generic pool of 34 CMV and EBV peptides that represent well-defined dominant T-cell epitopes with various HLA restrictions. For HLA class I, this set of peptides covers at least 80% of the European population. CMV/EBV-specific T cells were successfully expanded from leukapheresis material of both G-CSF mobilized and non-mobilized donors. The protocol allows administration shortly after stem cell transplantation (d30+), storage over liquid nitrogen for iterated applications, and protection of the stem cell donor by avoiding a second leukapheresis. Our protocol allows for rapid and cost-efficient production of T cells for early transfusion after aSCT as a preventive approach. It is currently evaluated in a phase I/IIa clinical trial.

Virtual observatory tools and amateur radio observations supporting scientific analysis of Jupiter radio emissions

NASA Astrophysics Data System (ADS)

Cecconi, Baptiste; Hess, Sebastien; Le Sidaner, Pierre; Savalle, Renaud; Stéphane, Erard; Coffre, Andrée; Thétas, Emmanuel; André, Nicolas; Génot, Vincent; Thieman, Jim; Typinski, Dave; Sky, Jim; Higgins, Chuck; Imai, Masafumi

2016-04-01

In the frame of the preparation of the NASA/JUNO and ESA/JUICE (Jupiter Icy Moon Explorer) missions, and the development of a planetary sciences virtual observatory (VO), we are proposing a new set of tools directed to data providers as well as users, in order to ease data sharing and discovery. We will focus on ground based planetary radio observations (thus mainly Jupiter radio emissions), trying for instance to enhance the temporal coverage of jovian decametric emission. The data service we will be using is EPN-TAP, a planetary science data access protocol developed by Europlanet-VESPA (Virtual European Solar and Planetary Access). This protocol is derived from IVOA (International Virtual Observatory Alliance) standards. The Jupiter Routine Observations from the Nancay Decameter Array are already shared on the planetary science VO using this protocol, as well as data from the Iitate Low Frquency Radio Antenna, in Japan. Amateur radio data from the RadioJOVE project is also available. The attached figure shows data from those three providers. We will first introduce the VO tools and concepts of interest for the planetary radioastronomy community. We will then present the various data formats now used for such data services, as well as their associated metadata. We will finally show various prototypical tools that make use of this shared datasets.

German flooding of the Pontine Marshes in World War II.

PubMed

Geissler, Erhard; Guillemin, Jeanne

2010-03-01

The German army's 1943 flooding of the Pontine Marshes south of Rome, which later caused a sharp rise in malaria cases among Italian civilians, has recently been described by historian Frank Snowden as a unique instance of biological warfare and bioterrorism in the European theater of war and, consequently, as a violation of the 1925 Geneva Protocol prohibiting chemical and biological warfare. We argue that archival documents fail to support this allegation, on several counts. As a matter of historical record, Hitler prohibited German biological weapons (BW) development and consistently adhered to the Geneva Protocol. Rather than biological warfare against civilians, the Wehrmacht used flooding, land mines, and the destruction of vital infrastructure to obstruct the Allied advance. To protect its own troops in the area, the German army sought to contain the increased mosquito breeding likely to be caused by the flooding. Italians returning to the Pontine Marshes after the German retreat in 1944 suffered malaria as a result of environmental destruction, which was banned by the 1899 and 1907 Hague Conventions and by subsequent treaties. In contrast, a state's violation of the Geneva Protocol, whether past or present, involves the use of germ weapons and, by inference, a state-level capability. Any allegation of such a serious violation demands credible evidence that meets high scientific and legal standards of proof.

Temperature management during semen processing: Impact on boar sperm quality under laboratory and field conditions.

PubMed

Schulze, M; Henning, H; Rüdiger, K; Wallner, U; Waberski, D

2013-12-01

Freshly collected boar spermatozoa are sensitive to a fast reduction in temperature because of lipid phase transition and phase separation processes. Temperature management during semen processing may determine the quality of stored samples. The aim of this study was to evaluate the influence of isothermic and hypothermic semen processing protocols on boar sperm quality under laboratory and field conditions. In the laboratory study, ejaculates (n = 12) were first diluted (1:1) with Beltsville Thawing Solution (BTS) at 32 °C, then processed either with isothermic (32 °C) or hypothermic (21 °C) BTS, stored at 17 °C, and assessed on days 1, 3, and 6. Temperature curves showed that 150 minutes after the first dilution, semen doses of both groups reached the same temperature. Two-step hypothermic processing resulted in lower sperm motility on days 1 and 6 (P < 0.05). Concomitantly, hypothermally processed samples contained less membrane intact sperm on days 3 and 6 (P < 0.05). Using AndroStar Plus extender instead of BTS reduced the negative effect of hypothermic processing. In the field study, 15 semen samples from each of 23 European artificial insemination studs were evaluated as part of an external quality control program. Semen quality based on motility, membrane integrity, mitochondrial activity, and a thermoresistance test was higher for stations using one-step isothermic dilutions (n = 7) compared with artificial insemination centers using two-step hypothermic protocols (n = 16). Both studies show that chilling injury associated with hypothermic dilution results in lower quality of stored boar semen compared with isothermic dilution and that the type of semen extender affects the outcomes. Copyright © 2013 Elsevier Inc. All rights reserved.

Role of antibiotic prophylaxis in antenatal hydronephrosis: A systematic review from the European Association of Urology/European Society for Paediatric Urology Guidelines Panel.

PubMed

Silay, Mesrur Selcuk; Undre, Shabnam; Nambiar, Arjun K; Dogan, Hasan Serkan; Kocvara, Radim; Nijman, Rien J M; Stein, Raimund; Tekgul, Serdar; Radmayr, Christian

2017-06-01

The benefits and harms of continuous antibiotic prophylaxis (CAP) versus observation in patients with antenatal hydronephrosis (ANH) are controversial. The aim was to determine the effectiveness of CAP for ANH, and if beneficial to determine the best type and regimen of antibiotic and the most harmful to provide guidance for clinical practice. A systematic literature search was performed in databases including Medline, Embase, and Cochrane in June 2015. The protocol was prospectively registered to PROSPERO (CRD42015024775). The search started from 1980, when maternal ultrasound was first introduced into clinical practice. Eligible studies were critically evaluated for risk of bias using Revman software. The outcomes included reduction in urinary tract infections (UTI), drug-related adverse events and kidney functions. Of 797 articles identified, 57 full text articles and six abstracts were eligible for inclusion (2 randomized controlled trials, 11 non-randomized comparative studies, and 50 case series). It remains unclear whether CAP is superior to observation in decreasing UTIs. No conclusion could be drawn for drug-related adverse events and kidney function because of lack of data. Children who were not circumcised, with ureteral dilatation, and high-grade hydronephrosis may be more likely to develop UTI, and CAP may be warranted for these subgroups of patients. A majority of the studies had low-to-moderate quality of evidence and with high risk of bias. The benefits of CAP in a heterogeneous group of children with ANH involving different etiologies remains unproven. However, the evidence in the form of prospective and retrospective observational studies has shown that it reduces febrile UTI in particular subgroups. Copyright © 2017 Journal of Pediatric Urology Company. Published by Elsevier Ltd. All rights reserved.

Transferability study of CHO cell clustering assays for monitoring of pertussis toxin activity in acellular pertussis vaccines.

PubMed

Isbrucker, R; Daas, A; Wagner, L; Costanzo, A

2016-01-01

Current regulations for acellular pertussis (aP) vaccines require that they are tested for the presence of residual or reversion-derived pertussis toxin (PTx) activity using the mouse histamine sensitisation test (HIST). Although a CHO cell clustering assay can be used by manufacturers to verify if sufficient inactivation of the substance has occurred in-process, this assay cannot be used at present for the final product due to the presence of aluminium adjuvants which interfere with mammalian cell cultures. Recently, 2 modified CHO cell clustering assays which accommodate for the adjuvant effects have been proposed as alternatives to the HIST. These modified assays eliminate the adjuvant-induced cytotoxicity either through dilution of the vaccine (called the Direct Method) or by introducing a porous barrier between the adjuvant and the cells (the Indirect Method). Transferability and suitability of these methods for testing of products present on the European market were investigated during a collaborative study organised by the European Directorate for the Quality of Medicines & HealthCare (EDQM). Thirteen laboratories participated in this study which included 4 aP-containing vaccines spiked by addition of PTx. This study also assessed the transferability of a standardised CHO cell clustering assay protocol for use with non-adjuvanted PTx preparations. Results showed that the majority of laboratories were able to detect the PTx spike in all 4 vaccines at concentrations of 4 IU/mL or lower using the Indirect Method. This sensitivity is in the range of the theoretical sensitivity of the HIST. The Direct Method however did not show the expected results and would need additional development work.