Feasibility of Ecological Momentary Assessment of Daily Sexting and Substance Use Among Young Adult African American Gay and Bisexual Men: A Pilot Study.

PubMed

Smiley, Sabrina L; Elmasry, Hoda; Webb Hooper, Monica; Niaura, Raymond S; Hamilton, Alison B; Milburn, Norweeta G

2017-02-02

Recent evidence suggests that sexualized text communication ("sexting") is associated with substance use and sexual risk behaviors among young adults, yet little is known about this relationship among young adult African American gay and bisexual men, a population disproportionately impacted by HIV in the United States. Rapid advances in mobile phone technology indicate a clear need for research using mobile health (mHealth) methods such as ecological momentary assessment (EMA) to serve as a viable counterpart to retrospective evaluation methods by using real-time data collection to assess sexting and substance use among this population. The objective of this pilot study was to (1) describe the EMA study design and protocol, (2) characterize the study population, and (3) assess the feasibility of a random prompt text message-based thrice-daily EMA over 14 days, as a means of prospectively studying sexting, marijuana, and alcohol use among a sample of young adult African American gay and bisexual men ages 21 to 25. Participants were recruited through flyers and snowball sampling during spring and summer 2015 at a community-based HIV/AIDS prevention, care, and support organization in Washington, DC. Eligible participants were enrolled in a one-time in-person study visit that consisted of informed written consent to participate in the study, a self-administered survey, a semi-structured interview, and enrollment and training in EMA data collection. Commencing the day after the study visit, a random prompt survey was texted to participants on their personal mobile phones 3 times a day over a 14-day data collection period assessing mood, texts sent, texts received, sexts sent, sexts received, marijuana want, marijuana use, and alcohol use. EMA feasibility was tested with 25 self-identified African American gay (n=16) and bisexual (n=9) men (mean age of 23.48 years, SD 1.5). Each random prompt survey had 8 questions with responses including yes/no and Likert scale options. There were 104 total days of EMA observation, and the retention rate was 72% (18 out of 25 participants). Participants responded to the random prompt surveys with a 57.3% compliance rate providing a total of 544 completed surveys out of 949 surveys. The overall mean response time to complete a survey was 6.1 minutes. There were significant positive associations between EMA texts sent and received questions (ρ 0.84, P<.001) as well as sexts sent and received queries (ρ 0.72, P<.001). The use of an EMA protocol has the potential to be a very useful research tool for understanding episodic behaviors such as sexting and substance use in this relatively understudied and underserved population, and has implications for practice. Additional research is needed on how to maximize survey compliance. ©Sabrina L Smiley, Hoda Elmasry, Monica Webb Hooper, Raymond S Niaura, Alison B Hamilton, Norweeta G Milburn. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 02.02.2017.

Ecological Momentary Assessment in Behavioral Research: Addressing Technological and Human Participant Challenges

PubMed Central

Shiffman, Saul; Music, Edvin; Styn, Mindi A; Kriska, Andrea; Smailagic, Asim; Siewiorek, Daniel; Ewing, Linda J; Chasens, Eileen; French, Brian; Mancino, Juliet; Mendez, Dara; Strollo, Patrick; Rathbun, Stephen L

2017-01-01

Background Ecological momentary assessment (EMA) assesses individuals’ current experiences, behaviors, and moods as they occur in real time and in their natural environment. EMA studies, particularly those of longer duration, are complex and require an infrastructure to support the data flow and monitoring of EMA completion. Objective Our objective is to provide a practical guide to developing and implementing an EMA study, with a focus on the methods and logistics of conducting such a study. Methods The EMPOWER study was a 12-month study that used EMA to examine the triggers of lapses and relapse following intentional weight loss. We report on several studies that informed the implementation of the EMPOWER study: (1) a series of pilot studies, (2) the EMPOWER study’s infrastructure, (3) training of study participants in use of smartphones and the EMA protocol and, (4) strategies used to enhance adherence to completing EMA surveys. Results The study enrolled 151 adults and had 87.4% (132/151) retention rate at 12 months. Our learning experiences in the development of the infrastructure to support EMA assessments for the 12-month study spanned several topic areas. Included were the optimal frequency of EMA prompts to maximize data collection without overburdening participants; the timing and scheduling of EMA prompts; technological lessons to support a longitudinal study, such as proper communication between the Android smartphone, the Web server, and the database server; and use of a phone that provided access to the system’s functionality for EMA data collection to avoid loss of data and minimize the impact of loss of network connectivity. These were especially important in a 1-year study with participants who might travel. It also protected the data collection from any server-side failure. Regular monitoring of participants’ response to EMA prompts was critical, so we built in incentives to enhance completion of EMA surveys. During the first 6 months of the 12-month study interval, adherence to completing EMA surveys was high, with 88.3% (66,978/75,888) completion of random assessments and around 90% (23,411/25,929 and 23,343/26,010) completion of time-contingent assessments, despite the duration of EMA data collection and challenges with implementation. Conclusions This work informed us of the necessary preliminary steps to plan and prepare a longitudinal study using smartphone technology and the critical elements to ensure participant engagement in the potentially burdensome protocol, which spanned 12 months. While this was a technology-supported and -programmed study, it required close oversight to ensure all elements were functioning correctly, particularly once human participants became involved. PMID:28298264

Understanding Environmental and Contextual Influences of Physical Activity During First-Year University: The Feasibility of Using Ecological Momentary Assessment in the MovingU Study

PubMed Central

Bedard, Chloe; King-Dowling, Sara; McDonald, Madeline; Dunton, Genevieve; Cairney, John

2017-01-01

Background It is well established that drastic declines in physical activity (PA) occur during young adults’ transition into university; however, our understanding of contextual and environmental factors as it relates to young adults’ PA is limited. Objective The purpose of our study was to examine the feasibility of using wrist-worn accelerometers and the use of ecological momentary assessment (EMA) to assess the context and momentary correlates of PA on multiple occasions each day during first-year university. Methods First-year university students were asked to participate in the study. The participants completed a brief questionnaire and were subsequently asked to wear an ActiGraph GT9X-Link accelerometer and respond to a series of EMA prompts (7/day) via their phones for 5 consecutive days. Results A total of 96 first-year university students with smartphones agreed to participate in the study (mean age 18.3 [SD 0.51]; n=45 females). Overall, there was good compliance for wearing the accelerometers, with 91% (78/86) of the participants having ≥2 days of ≥10 hours of wear time (mean=3.53 valid days). Students were generally active, averaging 10,895 steps/day (SD 3413) or 1123.23 activity counts/min (SD 356.10). Compliance to EMA prompts was less desirable, with 64% (55/86) of the participants having usable EMA data (responding to a minimum of ≥3 days of 3 prompts/day or ≥4 days of 2 prompts/day), and only 47% (26/55) of these participants were considered to have excellent EMA compliance (responding to ≥5 days of 4 prompts/day or ≥ 4 days of 5 prompts/day). Conclusions This study represents one of the first studies to use an intensive real-time data capture strategy to examine time-varying correlates of PA among first-year university students. These data will aim to describe the physical and social contexts in which PA occurs and examine the relationships between momentary correlates of PA among the first-year university students. Overall, current results suggest that wrist-worn accelerometers and EMA are feasible methods for data collection among the young adult population; however, more work is needed to understand how to improve upon compliance to a real-time data capture method such as EMA. PMID:28566264

Alcohol craving in adolescents: bridging the laboratory and natural environment.

PubMed

Ramirez, Jason; Miranda, Robert

2014-04-01

Initial lab studies suggest that adolescent drinkers crave alcohol when presented with alcohol cues. Whether this effect generalizes to the natural environment, however, remains unknown, and studies have not examined whether craving predicts drinking among youths. This study builds on existing research by pairing controlled lab-based cue reactivity assessments (CRAs) with data collected in the natural environment using ecological momentary assessment (EMA) methods. We examined whether alcohol cues evoke craving among adolescent drinkers in the lab and natural environment, and tested the clinical relevance of craving during adolescence by examining the prospective association between craving and alcohol use. Non-treatment-seeking adolescent drinkers (N = 42; ages 15 to 20 years) completed a lab-based CRA followed by a 1-week EMA monitoring period. During the EMA period, youth were prompted randomly throughout the day to record momentary data on craving and contextual factors (e.g., alcohol cues, peers present). Alcohol cues elicited craving in the lab, and this effect generalized to the natural environment, especially among adolescents with more alcohol problems. In addition, craving predicted subsequent drinking levels in the natural environment. This study demonstrates the utility of pairing lab paradigms with EMA methods to better characterize adolescents' reactivity to alcohol cues. Results implicate craving as a clinically meaningful motivator for drinking among adolescents and highlight a potentially important target of pharmacological or behavioral intervention.

Ecological Momentary Assessment in Behavioral Research: Addressing Technological and Human Participant Challenges.

PubMed

Burke, Lora E; Shiffman, Saul; Music, Edvin; Styn, Mindi A; Kriska, Andrea; Smailagic, Asim; Siewiorek, Daniel; Ewing, Linda J; Chasens, Eileen; French, Brian; Mancino, Juliet; Mendez, Dara; Strollo, Patrick; Rathbun, Stephen L

2017-03-15

Ecological momentary assessment (EMA) assesses individuals' current experiences, behaviors, and moods as they occur in real time and in their natural environment. EMA studies, particularly those of longer duration, are complex and require an infrastructure to support the data flow and monitoring of EMA completion. Our objective is to provide a practical guide to developing and implementing an EMA study, with a focus on the methods and logistics of conducting such a study. The EMPOWER study was a 12-month study that used EMA to examine the triggers of lapses and relapse following intentional weight loss. We report on several studies that informed the implementation of the EMPOWER study: (1) a series of pilot studies, (2) the EMPOWER study's infrastructure, (3) training of study participants in use of smartphones and the EMA protocol and, (4) strategies used to enhance adherence to completing EMA surveys. The study enrolled 151 adults and had 87.4% (132/151) retention rate at 12 months. Our learning experiences in the development of the infrastructure to support EMA assessments for the 12-month study spanned several topic areas. Included were the optimal frequency of EMA prompts to maximize data collection without overburdening participants; the timing and scheduling of EMA prompts; technological lessons to support a longitudinal study, such as proper communication between the Android smartphone, the Web server, and the database server; and use of a phone that provided access to the system's functionality for EMA data collection to avoid loss of data and minimize the impact of loss of network connectivity. These were especially important in a 1-year study with participants who might travel. It also protected the data collection from any server-side failure. Regular monitoring of participants' response to EMA prompts was critical, so we built in incentives to enhance completion of EMA surveys. During the first 6 months of the 12-month study interval, adherence to completing EMA surveys was high, with 88.3% (66,978/75,888) completion of random assessments and around 90% (23,411/25,929 and 23,343/26,010) completion of time-contingent assessments, despite the duration of EMA data collection and challenges with implementation. This work informed us of the necessary preliminary steps to plan and prepare a longitudinal study using smartphone technology and the critical elements to ensure participant engagement in the potentially burdensome protocol, which spanned 12 months. While this was a technology-supported and -programmed study, it required close oversight to ensure all elements were functioning correctly, particularly once human participants became involved. ©Lora E Burke, Saul Shiffman, Edvin Music, Mindi A Styn, Andrea Kriska, Asim Smailagic, Daniel Siewiorek, Linda J Ewing, Eileen Chasens, Brian French, Juliet Mancino, Dara Mendez, Patrick Strollo, Stephen L Rathbun. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 15.03.2017.

Feasibility of a Mobile Phone App to Support Recovery From Addiction in China: Secondary Analysis of a Pilot Study.

PubMed

Han, Hui; Zhang, Jing Ying; Hser, Yih-Ing; Liang, Di; Li, Xu; Wang, Shan Shan; Du, Jiang; Zhao, Min

2018-02-27

Mobile health technologies have been found to improve the self-management of chronic diseases. However, there is limited research regarding their feasibility in supporting recovery from substance use disorders (SUDs) in China. The objective of this study was to examine the feasibility of a mobile phone-based ecological momentary assessment (EMA) app by testing the concordance of drug use assessed by the EMA, urine testing, and a life experience timeline (LET) assessment. A total of 75 participants dependent on heroin or amphetamine-type stimulant (ATS) in Shanghai were recruited to participate in a 4-week pilot study. Of the participants, 50 (67% [50/75]) were randomly assigned to the experimental group and 25 (33% [25/75]) were assigned to the control group. The experimental group used mobile health (mHealth) based EMA technology to assess their daily drug use in natural environments and received 2 short health messages each day, whereas the control group only received 2 short health messages each day from the app. Urine tests and LET assessments were conducted each week and a post-intervention survey was administered to both groups. The correlations among the EMA, the LET assessment, and the urine test were investigated. The mean age of the participants was 41.6 (SD 8.0) years, and 71% (53/75) were male. During the 4 weeks of observation, 690 daily EMA survey data were recorded, with a response rate of 49.29% (690/1400). With respect to drug use, the percent of agreement between the EMA and the LET was 66.7%, 79.2%, 72.4%, and 85.8%, respectively, for each of the 4 weeks, whereas the percent of agreement between the EMA and the urine test was 51.2%, 65.1%, 61.9%, and 71.5%, respectively. The post-intervention survey indicated that 46% (32/70) of the participants preferred face-to-face interviews rather than the mHealth app. This study demonstrated poor agreement between the EMA data and the LET and found that the acceptance of mHealth among individuals with SUDs in China was not positive. Hence, greater efforts are needed to improve the feasibility of mHealth in China. ©Hui Han, Jing Ying Zhang, Yih-Ing Hser, Di Liang, Xu Li, Shan Shan Wang, Jiang Du, Min Zhao. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 27.02.2018.

A New Ethical Challenge for Institutional Review Boards (IRBs)/Ethics Committees (ECs) in the Assessment of Pediatric Clinical Trials.

PubMed

Rose, Klaus; Kummer, Hans

2015-05-28

Both the US and EU have introduced pediatric pharmaceutical legislation to facilitate clinical trials in children and development of better medicines for children. The first concerns were published in 2014 that the European Medicines Agency (EMA)'s Pediatric Committee (PDCO) may be over-enthusiastic and has compelled questionable pediatric clinical trials from pharmaceutical companies. Numerous clinical trials are mandated in rare conditions for which not enough patients exist for even one trial. Furthermore, where these trials are mandated in adolescent patients, the legal age limit of the 18th birthday is confused with a medical age limit and can result in separate clinical trials in adolescent patients that neither make medical nor scientific sense nor will ever recruit enough patients for a meaningful outcome. To confirm our concerns we searched the registry clinicaltrials.gov and found examples for PDCO-triggered unethical trials. We conclude that such trials should not be accepted by institutional review boards (IRBs)/ethics committees (ECs) and that clinical trials resulting from negotiations with EMA's PDCO need extra careful scrutiny by IRBs/ECs in order to prevent unethical studies and damage to pediatric research and unnecessary risks to pediatric patients.

SPRINTT and the involvement of stakeholders: strategy and structure.

PubMed

Le Lain, Régis; Ignaszewski, Claire; Klingmann, Ingrid; Cesario, Alfredo; de Boer, Willem Ivo

2017-02-01

The current healthcare systems are built around the traditional paradigm of patients suffering from a single acute illness. They are, therefore, largely unprepared to face the increasing demands for health services arising from the expansion of an older population with specific medical needs related to multiple chronic disorders. As a consequence, the medical conditions of a large and growing segment of the older European population are not efficiently managed by the available healthcare services. In the context of an aging population, policy makers such as the European Commission and European Institutions, such as the European Medicines Agency (EMA), devote time and resources to study and accompany the need of the aging population. The EMA recognizes the importance of making sure that the needs of the Elderly are considered during development, approval, and use of new medicines, and, therefore, engages with healthcare professional organisations. The Sarcopenia and Physical Frailty in Older People: Multicomponent Intervention Strategies (SPRINTT) is the obvious result of these strategies. The present article describes the SPRINTT workpackage activities aimed at engaging the scientific discussion on the physical frailty and sarcopenia with the EMA as one of its interlocutor, acknowledging the need to collaborate on this topic to foster a productive dialogue.

Momentary assessment of affect, physical feeling states, and physical activity in children.

PubMed

Dunton, Genevieve F; Huh, Jimi; Leventhal, Adam M; Riggs, Nathaniel; Hedeker, Donald; Spruijt-Metz, Donna; Pentz, Mary Ann

2014-03-01

Most research on the interplay of affective and physical feelings states with physical activity in children has been conducted under laboratory conditions and fails to capture intraindividual covariation. The current study used Ecological Momentary Assessment (EMA) to bidirectionally examine how affective and physical feeling states are related to objectively measured physical activity taking place in naturalistic settings during the course of children's everyday lives. Children (N = 119, ages 9-13 years, 52% male, 32% Hispanic) completed 8 days of EMA monitoring, which measured positive affect (PA), negative affect (NA), feeling tired, and feeling energetic up to 7 times per day. EMA responses were time-matched to accelerometer assessed moderate-to-vigorous physical activity (MVPA) in the 30 min before and after each EMA survey. Higher ratings of feeling energetic and lower ratings of feeling tired were associated with more MVPA in the 30 min after the EMA prompt. More MVPA in the 30 min before the EMA prompt was associated with higher ratings of PA and feeling energetic and lower ratings of NA. Between-subjects analyses indicated that mean hourly leisure-time MVPA was associated with less intraindividual variability in PA and NA. Physical feeling states predict subsequent physical activity levels, which in turn, predict subsequent affective states in children. Active children demonstrated higher positive and negative emotional stability. Although the strength of these associations were of modest magnitude and their clinical relevance is unclear, understanding the antecedents to and consequences of physical activity may have theoretical and practical implications for the maintenance and promotion of physical activity and psychological well-being in children. PsycINFO Database Record (c) 2014 APA, all rights reserved.

A Pilot Study to Examine the Feasibility and Potential Effectiveness of Using Smartphones to Provide Recovery Support for Adolescents

PubMed Central

Dennis, Michael L.; Scott, Christy K; Funk, Rodney R.; Nicholson, Lisa

2014-01-01

Background Smartphone applications can potentially provide recovery monitoring and support in real-time, real-life contexts. Study aims included determining feasibility of: a) Adolescents completing ecological momentary assessments (EMA) and utilizing phone-based ecological momentary interventions (EMI); and b) Using EMA and EMI data to predict substance use in the subsequent week. Methods Twenty-nine adolescents were recruited at discharge from residential treatment, regardless of their discharge status or length of stay. During the 6-week pilot, youth were prompted to complete an EMA at 6 random times per day and were provided access to a suite of recovery support EMI. Youth completed 87% of the 5,580 EMAs. Based on use in the next 7 days, EMA observations were classified into 3 risk groups: “Current Use” in the past 30 minutes (3% of observations), “Unrecognized Risk” (42%), or “Recognized Risk” (55%). All youth had observations in 2 or more risk groups and 38%, in all three. Youth accessed an EMI on-average 162 times each week. Results Participants were: 31% female, 48% African American, 21% Caucasian, 7% Hispanic, 24% Mixed/Other, average age 16.6 years. During the 90 days prior to entering treatment, youth reported using alcohol (38%), marijuana (41%), and other drugs (7%). When compared to the “Recognized Risk” group’s use in the following week (31%), both the “Unrecognized Risk” (50%, OR=2.08) and “Current Use” (96%, OR=50.30) groups reported significantly higher rates of use in the next week. When an EMI was accessed 2 or more times within the hour following an EMA, the rate of using during the next week was significantly lower than when EMIs were not accessed (32% vs. 43%, OR=0.62). Conclusions Results demonstrate the feasibility of using smartphones for recovery monitoring and support with adolescents, with potential to reduce use. PMID:25310057

Do the EMA accelerated assessment procedure and the FDA priority review ensure a therapeutic added value? 2006-2015: a cohort study.

PubMed

Boucaud-Maitre, Denis; Altman, Jean-Jacques

2016-10-01

The Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have both implemented procedures in order to shorten review time for marketing authorizations with potential therapeutic added value, called priority review and accelerated assessment procedure, respectively. The aim of this study is to compare the new molecular entities (NME) assessed in shorter review time by both agencies and to investigate whether granting a shorter review time status subsequently predicts its therapeutic value attributed by a health technology assessment agency, the French Haute Autorité de Santé (HAS). All NME approved by the EMA and the FDA with a therapeutic added value between 2007 and June 30, 2015 were extracted. We assessed the sensibility, the positive predictive value, and the EMA review time. One hundred seventy-eight NME were approved by the FDA and the EMA and a therapeutic value was available for 160 NME. Eighty-eight (55.0 %) NME were on FDA priority review, 24 (15.0 %) on EMA accelerated procedure and 43 (26.9 %) were considered of high clinical added value. The sensibility was 86.0 % for the FDA and 30.2 % for the EMA. The positive predictive value was, respectively, 42.0 and 54.2 %. Twenty-five NME on FDA priority review and of high therapeutic added value were not on EMA accelerated assessment procedure, leading to a supplementary mean EMA review time of 146 days. The EMA was restrictive to grant a shorten review time status for products with therapeutic interest during the study period.

Understanding Environmental and Contextual Influences of Physical Activity During First-Year University: The Feasibility of Using Ecological Momentary Assessment in the MovingU Study.

PubMed

Bedard, Chloe; King-Dowling, Sara; McDonald, Madeline; Dunton, Genevieve; Cairney, John; Kwan, Matthew

2017-05-31

It is well established that drastic declines in physical activity (PA) occur during young adults' transition into university; however, our understanding of contextual and environmental factors as it relates to young adults' PA is limited. The purpose of our study was to examine the feasibility of using wrist-worn accelerometers and the use of ecological momentary assessment (EMA) to assess the context and momentary correlates of PA on multiple occasions each day during first-year university. First-year university students were asked to participate in the study. The participants completed a brief questionnaire and were subsequently asked to wear an ActiGraph GT9X-Link accelerometer and respond to a series of EMA prompts (7/day) via their phones for 5 consecutive days. A total of 96 first-year university students with smartphones agreed to participate in the study (mean age 18.3 [SD 0.51]; n=45 females). Overall, there was good compliance for wearing the accelerometers, with 91% (78/86) of the participants having ≥2 days of ≥10 hours of wear time (mean=3.53 valid days). Students were generally active, averaging 10,895 steps/day (SD 3413) or 1123.23 activity counts/min (SD 356.10). Compliance to EMA prompts was less desirable, with 64% (55/86) of the participants having usable EMA data (responding to a minimum of ≥3 days of 3 prompts/day or ≥4 days of 2 prompts/day), and only 47% (26/55) of these participants were considered to have excellent EMA compliance (responding to ≥5 days of 4 prompts/day or ≥ 4 days of 5 prompts/day). This study represents one of the first studies to use an intensive real-time data capture strategy to examine time-varying correlates of PA among first-year university students. These data will aim to describe the physical and social contexts in which PA occurs and examine the relationships between momentary correlates of PA among the first-year university students. Overall, current results suggest that wrist-worn accelerometers and EMA are feasible methods for data collection among the young adult population; however, more work is needed to understand how to improve upon compliance to a real-time data capture method such as EMA. ©Chloe Bedard, Sara King-Dowling, Madeline McDonald, Genevieve Dunton, John Cairney, Matthew Kwan. Originally published in JMIR Public Health and Surveillance (http://publichealth.jmir.org), 31.05.2017.

Young Age at Diagnosis of Type 1 Diabetes Is Associated with the Development of Celiac Disease-Associated Antibodies in Children Living in Newfoundland and Labrador, Canada.

PubMed

Pall, Harpreet; Newhook, Leigh A; Aaron, Hillary; Curtis, Joseph; Randell, Ed

2015-10-14

The objectives of this study were to establish the prevalence of positive antibodies to endomysium (EMA) and tissue transglutaminase (tTG) in children with type 1 diabetes living in Newfoundland and Labrador (NL), and to examine clinical features associated with positive antibodies. Patients were recruited from the pediatric diabetes clinic. One hundred sixty-seven children with type 1 diabetes from the 280 children followed at the clinic were prospectively screened for celiac disease using EMA and tTG. The variables of Irish descent, age at onset of diabetes, duration of diabetes, sex, family history of celiac disease, hemoglobin A1C (A1C), ferritin, gastrointestinal symptoms, and body mass index were compiled for all patients. The group of patients with positive antibodies to EMA and/or tTG was compared to the group with negative antibodies. The prevalence of patients with positive antibodies to EMA and/or tTG was 16.8% (n = 28). One patient had also been previously diagnosed with symptomatic celiac disease. The two statistically significant variables with positive antibodies were an earlier age at onset of diabetes (Mann-Whitney U two-tailed test: mean difference 3.2 years, 95% CI 1.7-4.8 years, p < 0.0001) and longer duration of diabetes (Mann-Whitney U two-tailed test: mean difference 2.9 years, 95% CI 1.3-4.4 years, p < 0.0001). Irish descent was associated with positive antibodies but did not reach statistical significance. On logistic regression analysis performed with these three variables together, only age at onset of diabetes remained significant. There is a high prevalence of celiac disease-associated antibodies in children living in NL with type 1 diabetes. Unlike other clinical features, an earlier age at onset of diabetes was predictive for positive antibodies. As the majority of children with positive antibodies did not have signs or symptoms of celiac disease, routine screening for celiac disease in type 1 diabetes is recommended.

Symposium on Electromagnetic Launcher Technology, 5th, Sandestin, FL, Apr. 3-5, 1990, Proceedings

NASA Astrophysics Data System (ADS)

Gooden, Clarence E.

1991-01-01

The present conference on electromagnetic accelerators (EMAs) and railguns (RGs) discusses active-current management for four-rail RGs, the design of a compulsator-drive 60-caliber RG, EMA studies with augmented rails, muzzle-shunt augmentation of conventional RGs, effect of in-bore gas on RG performance, the distributed-energy store RG, plasma diagnostics for high power ignitron development, a review of EMA armature research, RG hybrid armatures, a new solid-armature design concept, and the electrodynamics of RG plasma armatures. Also discussed is RG modeling at speed using three-dimensional finite elements, power supply technology for EMAs, rotating machine power supplies for next-generation EMAs, advanced EMA power supplies with magnetic-flux compression, metal-to-metal switches for large currents, lightweight high-effiency energy-storage transformers, hypervelocity projectile development for EMAs, structural design issues for EMA projectiles, stiff RGs, a reinforced Al conductor for cryogenic applications, mass-stabilized projectile designs for EMA launch, indictively-commutated coilguns, an actively switched pulsed induction accelerator, a plasma gun-augmented electrothermal accelerator, a symmetrical rail accelerator, and a travelling-wave synchronous coil gun.

Determination of homologous distributions of bisEMA dimethacrylates in bulk-fill resin-composites by GC-MS.

PubMed

Durner, Jürgen; Schrickel, Klaus; Watts, David C; Ilie, Nicoleta

2015-04-01

Ethoxylated bisphenol A dimethacrylate (bisEMA) is a basis monomer in several dental resin composites. It was the aim of the present study to develop a method allowing detection of bisEMA and its different degrees of ethoxylation eluted from polymerized resin composites. High-temperature gas chromatography/mass spectrometry (HT-GC/MS) by direct on-column injection was used to identify ethoxylated bisEMA in ethanol/water (3:1) eluates from polymerized specimen of four bulk-fill resin composites - Venus(®) bulk fill, Surefil(®) SDR™ flow, Filtek™ Bulk Fill and Sonic Fill™. Additionally, the unpolymerised pastes were analysed. The developed method allowed identification of a homologous series of bisEMA up to twelve ethoxy groups in the unpolymerised materials. The molecular masses of the homologous bisEMA varied between 452 g/mol and 892 g/mol and were detected for retention times from 9.43 min to 13.36 min. Analysis of eluates from polymerised materials identified bisEMA monomers with less than 6 ethoxy groups. Chromatograms showed larger peak areas for the lower volatile bisEMA with 4-6 ethoxy groups compared with higher volatile bisEMA with 2 or 3 ethoxy groups, thus indicating that the amounts of these homologues in the pastes were higher. Ethoxylated bisEMA with up to twelve ethoxy groups can be identified by HT-GC/MS. In all eluates bisEMA was found. The higher the number of ethoxy groups the lower are the peak areas from bisEMA in the gas chromatogram. These findings may be significant for toxicological analysis of resin-composites incorporating bis-EMA. Copyright © 2015 Academy of Dental Materials. Published by Elsevier Ltd. All rights reserved.

Ecological Momentary Assessment Methodology in Chronic Pain Research: A Systematic Review.

PubMed

May, Marcella; Junghaenel, Doerte U; Ono, Masakatsu; Stone, Arthur A; Schneider, Stefan

2018-01-31

Self-reported pain intensity assessments are central to chronic pain research. Ecological momentary assessment (EMA) methodologies are uniquely positioned to collect these data, and are indeed being used in the field. However, EMA protocols are complex, and many decisions are necessary in the design of EMA research studies. A systematic literature review identified 105 articles drawing from 62 quantitative EMA research projects examining pain intensity in adult chronic pain patients. Study characteristics were tabulated to summarize and describe the use of EMA, with an emphasis placed on various dimensions of decision-making involved in executing EMA methodologies. Most identified studies considered within-person relationships between pain and other variables, and a few examined interventions on chronic pain. There was a trend toward the use of smartphones as EMA data collection devices more recently, and completion rates were not reported in nearly one third of studies. Pain intensity items varied widely with respect to number of scale points, anchor labels, and length of reporting period; most used numeric rating scales. Recommendations are provided for reporting to improve reproducibility, comparability, and interpretation of results, and for opportunities to clarify the importance of design decisions. Studies that use EMA methodologies to assess pain intensity are heterogeneous. Aspects of protocol design, including data input modality and pain item construction, have the potential to influence the data collected. Thorough reporting on design features and completion rates therefore facilitates reproducibility, comparability, and interpretation of study results. Copyright © 2018 The American Pain Society. Published by Elsevier Inc. All rights reserved.

Can end-of-day reports replace momentary assessment of pain and fatigue?

PubMed Central

Broderick, Joan E.; Schwartz, Joseph E.; Schneider, Stefan; Stone, Arthur A.

2009-01-01

This study evaluated the ability of end-of-day (EOD) ratings to accurately reflect momentary (EMA) ratings on 10 widely used pain and fatigue items. Rheumatology patients (N=105) completed ≥5 randomly scheduled EMA assessments of each item per day as well as EOD ratings. Correlations were high between EOD and EMA ratings of the five pain items (r= .90-.92) and somewhat lower for the five fatigue/energy items (r= .71-.86). To examine the ability of EOD ratings to represent a week of EMA ratings, 7 EOD ratings were averaged and correlated with EMA (r ≥ .95 for pain items, r = .88-.95 for fatigue/energy items). Further, averaging only 3-5 EOD ratings achieved very high correlations with a week of EMA ratings. Within-subject correlations of EOD with mean daily EMA across 7 days confirmed patients’ ability to provide daily ratings that accurately reflect their day-to-day variation in symptom levels. These EOD results were compared to traditional recall ratings collected in the same protocol. It was concluded (1) that EOD ratings were a better representation of EMA than were recall ratings, and (2) that EOD ratings across a reporting period can replace EMA for studies targeting average levels of pain or fatigue. Perspective This study in chronic pain patients demonstrated that end-of-day ratings of pain are highly accurate representations of average levels of pain experience across a day; Ratings of fatigue were somewhat less accurate, though still at a level that would be valid. PMID:19070550

Experience sampling and ecological momentary assessment studies in psychopharmacology: A systematic review.

PubMed

Bos, Fionneke M; Schoevers, Robert A; aan het Rot, Marije

2015-11-01

Experience sampling methods (ESM) and ecological momentary assessment (EMA) offer insight into daily life experiences, including symptoms of mental disorders. The application of ESM/EMA in psychopharmacology can be a valuable addition to more traditional measures such as retrospective self-report questionnaires because they may help reveal the impact of psychotropic medication on patients' actual experiences. In this paper we systematically review the existing literature on the use of ESM/EMA in psychopharmacology research. To this end, we searched the PsycInfo and Medline databases for all available ESM/EMA studies on the use of psychotropic medication in patients with DSM-III-R and DSM-IV disorders. Dissertations were excluded. We included 18 studies that applied ESM/EMA to study the effects of medication on patients with major depressive disorder, substance use disorder, attention-deficit hyperactivity disorder, psychotic disorder, and anxiety disorder. We found that ESM/EMA may allow researchers and clinicians to track patients during different phases of treatment: before treatment to predict outcome, during treatment to examine the effects of treatment on symptoms and different aspects of daily life experience, and after treatment to detect vulnerability for relapse. Moreover, ESM/EMA can potentially help determine how long and in what contexts medications are effective. Thus, ESM/EMA may benefit both researchers and clinicians and might prove to be an effective tool for improving the treatment of psychiatric patients. Copyright © 2015 Elsevier B.V. and ECNP. All rights reserved.

Effect of EMA and antioxidants on properties of thermoplastic starch blown films

NASA Astrophysics Data System (ADS)

Threepopnatkul, P.; Kulsetthanchalee, C.; Sittattrakul, A.; Kaewjinda, E.

2015-07-01

The objectives of this study were to investigate the effect of poly(ethylene-co-methyl acrylate) (EMA) at 10, 30 and 50 wt% on the morphological properties, moisture sorption, water vapor permeability and biodegradability of thermoplastic starch (TPS). Urea and formamide were used as a mixed plasticizer. In addition, the effect of antioxidants namely, 3,5-di-tert-butyl-4-hydroxyhydrocinnamate (DTBH), butylated hydroxytoluene (BHT) and bis(octadecyl)hydroxylamine (BOH) at 1 wt% on the properties of TPS/EMA film was investigated. TPS/EMA films were produced by a blown film molding machine and characterized by scanning electron microscropy, moisture sorption, water vapor permeability and biodegradability measurement. Results found that the increment of EMA content in the TPS matrix could improve the water sorption, water vapor permeability and biodegradability properties of TPS/EMA films. For biodegradation, the weight loss of the blended films was directly proportional to TPS content. Regarding the antioxidants effect, the water vapor permeability of TPS/EMA films containing DTBH was higher than the one with BOH and BHT. However, the antioxidants contributed little to the biodegradability of TPS/EMA films and had no effect on the moisture sorption of TPS/EMA films.

'I Got it off my Chest': An Examination of how Research Participation Improved the Mental Health of Women Engaging in Transactional Sex.

PubMed

Felsher, Marisa; Wiehe, Sarah E; Gunn, Jayleen K L; Roth, Alexis M

2018-02-01

Ecologic momentary assessment (EMA) is a form of close-ended diary writing. While it has been shown that participating in a study that incorporates EMA improves mental health of participants, no study to date has examined the pathways through which benefits may occur. For 4-weeks, twice-daily EMAs and weekly interviews captured mood, daily activities and HIV risk behavior of 25 women who engage in transactional sex. Qualitative analysis of exit interviews was performed to examine how participation impacted women's mental health. The majority of participants felt that EMAs heightened awareness of emotions and behavior. Most reported experiencing catharsis from the interviews; specifically, from having a non-judgmental, trusting listener. Participants felt responsible for completing tasks, a sense of accomplishment for completing the study, and altruism. This study demonstrates there are direct benefits associated with participation in an EMA and interview study.

Momentary Assessment of Psychosocial Stressors, Context, and Asthma Symptoms in Hispanic Adolescents

PubMed Central

Dunton, Genevieve Fridlund; Dzubur, Eldin; Li, Marilyn; Huh, Jimi; McConnell, Rob; Intille, Stephen

2017-01-01

Objective The current study used a novel real-time data capture strategy, Ecological Momentary Assessment (EMA), to examine whether within-day variability in stress and context leads to exacerbations in asthma symptomatology in the everyday lives of ethnic minority adolescents. Methods Low-income, Hispanic adolescents (N = 20) (7th–12th grade) (54% male) with chronic asthma completed seven days of EMA on smartphones, with an average of five assessments per day during non-school time. EMA surveys queried about where (e.g., home, outdoors) and with whom (e.g., alone, with friends) participants were at the time of the prompt. EMA surveys also assessed over the past few hours whether participants had experienced specific stressors (e.g., being teased, arguing with anyone), asthma symptoms (e.g., wheezing, coughing), or used an asthma inhaler. Multilevel models tested the independent relations of specific stressors, and context to subsequent asthma symptoms adjusting for age, gender, and chronological day in the study. Results Being outdoors and experiencing disagreements with parents, teasing, or arguing were associated with more severe self-reported asthma symptoms in the next few hours (p’s < .05). Being alone and having too much to do were unrelated to the experience of subsequent self-reported asthma symptoms. Conclusions Using a novel real-time data capture strategy, results provide preliminary evidence that being outdoors and experiencing social stressors may induce asthma symptoms in low-income Hispanic children and adolescents with chronic asthma. The results of this preliminary study can serve as the basis for larger epidemiological and intervention studies. PMID:26438664

A comparison of new drugs approved by the FDA, the EMA, and Swissmedic: an assessment of the international harmonization of drugs.

PubMed

Zeukeng, Minette-Joëlle; Seoane-Vazquez, Enrique; Bonnabry, Pascal

2018-06-01

This study compared the characteristics of new human drugs approved by the Food and Drug Administration (FDA), the European Medicine Agency (EMA), and Swissmedic (SMC) in the period 2007 to 2016. The list of new drugs and therapeutic biologics approved by the FDA, the EMA, and SMC in the period 2007 to 2016 was collected from websites of those agencies. The study included regulatory information, approval date, and indication for each drug. Descriptive statistical t tests and x 2 -tests were performed for the analysis. From 2007 to 2016, 134 new drugs were approved by all three regulatory agencies. Overall, 66.4% of the drugs were first approved by the FDA, 30.6% by the EMA, and 3.0% by SMC. The difference in approval dates between SMC and the EMA, SMC and the FDA, and the FDA and the EMA were statistically significant. The indications approved by the FDA, the EMA, and SMC for the same drugs were similar in content for 23.1% drugs and different in 76.9% of the drugs. Significant differences in indications existed between the FDA and SMC and the FDA and the EMA, but not between the EMA and SMC. There were differences in the characteristics of new drugs approved by the EMA, the FDA, and SMC in the period 2007-2016. Overall, two thirds of the new drugs were first approved by the FDA. Differences in indications were found in three out of four new drugs approved by the three regulatory agencies. Despite international drug regulation harmonization efforts, significant differences in the characteristics of new drugs approved by different agencies persist.

Feasibility of Smartphone-Based Education Modules and Ecological Momentary Assessment/Intervention in Pre-bariatric Surgery Patients.

PubMed

Mundi, Manpreet S; Lorentz, Paul A; Grothe, Karen; Kellogg, Todd A; Collazo-Clavell, Maria L

2015-10-01

Bariatric surgery is the most effective means of long-term weight loss. Knowledge gaps and lack of engagement in pre-operative patients can result in suboptimal outcome after surgery. Mobile technology, utilizing ecological momentary assessment (EMA)/intervention (EMI), has shown tremendous promise in changing behaviors. The primary objective of the study is to assess feasibility of using smartphone app with EMA/EMI functionality to prepare patients for bariatric surgery. Subjects seeking primary bariatric surgery were provided a smartphone app containing video-based education modules with linked assessments to evaluate mastery of topic. Subjects received algorithmic EMA text messages soliciting a response regarding lifestyle behavior. Upon answering, subjects received tailored EMI text messaging supporting healthy lifestyle. Thirty subjects (27 female and 3 male), with age of 41.3 ± 11.4 years and BMI of 46.3 ± 7.4 kg/m(2) were enrolled. Twenty subjects completed the study. Ten subjects withdrew. On average, seven out of nine education modules were completed (70.9 ± 27.3%), and 37.8/123 EMA were answered (30.7 ± 21.7%), with response time of 17.4 ± 4.4 min. Subjects reported high satisfaction with the app. Many felt that the app fit into their routine "somewhat easily" or "very easily" (n = 12), had "perfect" amount of EMA messages (n = 8), and was very helpful in preparing for surgery (n = 7). This study is the first to reveal the feasibility of using a smartphone app in the education and engagement of patients prior to bariatric surgery. The app was well-received based on subject satisfaction scores and revealed trends toward positive behavior change and increased weight loss. Randomized trials are necessary to delineate true efficacy.

Does the Company of a Dog Influence Affective Response to Exercise? Using Ecological Momentary Assessment to Study Dog-Accompanied Physical Activity.

PubMed

Liao, Yue; Solomon, Olga; Dunton, Genevieve F

2017-09-01

This study used ecological momentary assessment (EMA), a real-time self-report strategy, to examine (1) whether dog owners were more likely to be physically active when they were with their dogs and (2) whether being with a dog amplifies positive and dampens negative affective response during physical activity. Electronic EMA surveys for 12 days. Free-living. Seventy-one adult dog owners. The EMA survey included 1 question about current activity, 3 questions about positive affect (Cronbach α = .837), 4 questions about negative affect (Cronbach α = .865), and 1 question about the presence of dog. Multilevel modeling. The company of a dog did not increase the likelihood of being active versus sedentary at any given EMA prompt. However, greater positive affect during physical activity was reported in the company of a dog. Negative affect did not differ between active and sedentary activity, regardless of being with a dog or not. This study demonstrates the utility of electronic EMA as a promising methodology to study dog-accompanied physical activity. Future studies may use EMA to collect further contextual information about dog-accompanied activity to inform the development of innovative physical activity interventions.

Monitoring dietary intake and physical activity electronically: feasibility, usability, and ecological validity of a mobile-based Ecological Momentary Assessment tool.

PubMed

Spook, Jorinde Eline; Paulussen, Theo; Kok, Gerjo; Van Empelen, Pepijn

2013-09-24

Despite the growing body of research on complex lifestyle behaviors (eg, Dietary Intake [DI] and Physical Activity [PA]), monitoring of these behaviors has been hampered by a lack of suitable methods. A possible solution to this deficiency is mobile-based Ecological Momentary Assessment (mEMA), which enables researchers to collect data on participants' states in real-time by means of a smartphone application. However, feasibility, usability, and ecological validity need to be anticipated and managed in order to enhance the validity of mEMA. To examine the feasibility, usability, and ecological validity of a mEMA application (app) with regard to DI and PA among Dutch vocational education students. The students (n=30) participated in the mEMA study for seven consecutive days. They downloaded the mEMA app on their smartphone. Feasibility and usability of the mEMA app were evaluated by completing an online evaluation after seven days of participation. Ecological validity was measured by assessing the degree to which the content of the mEMA app approximated the real-world setting that was being examined, through several multiple-choice questions. Compliance rates, as registered by the mEMA app, declined 46% over a seven-day period, while self-reported compliance, as measured with an online evaluation questionnaire afterwards, indicated a smaller decrease in compliance (29%). The students evaluated the mEMA app as feasible and usable. Ecological validity analyses showed that all DI and almost all PA multiple-choice options were covered with the compound response categories. The mEMA app offers the opportunity to assess complex health behaviors (eg, DI and PA) in real-time settings, in which specifically routinized behaviors are involved. However, the mEMA app faced several challenges that needed to be overcome in order to improve its validity. Overall, the present study showed that the mEMA app is a usable and ecologically valid tool to measure DI and PA behaviors among vocational education students, but compliance is still limited.

EMA401: an old antagonist of the AT2R for a new indication in neuropathic pain.

PubMed

Keppel Hesselink, Jan M; Schatman, Michael E

2017-01-01

EMA401 is an old molecule, synthesized by Parke-Davis in the last century and characterized at that time as an AT2R antagonist. Professor Maree Smith and her group from the University of Queensland (Australia) patented the drug and many related derivatives and other compounds with high affinity for the AT2R for the indication neuropathic pain in 2004, an example of drug repositioning. After some years of university work, the Australian biotech company Spinifex Pharmaceuticals took over further research and development and characterized the S-enantiomer, code name EMA401, and related compounds in a variety of animal models for neuropathic and cancer pain. EMA401 was selected as the lead compound, based on high selectivity for the AT2R and good oral bioavailability (33%). EMA401, however, was only administered once in a chronic neuropathic pain model, and no data have been published in other pain models, or during steady state, although such data were available for the racemate EMA400 and some related compounds (EMA200, EMA400). A pilot phase IIa study demonstrated the efficacy and safety of the drug taken twice daily as two capsules of 50 mg (400 mg/day). In 2015, Novartis took over the clinical development. Two phase IIb studies designed by Spinifex Pharmaceuticals were put on hold, probably because Novartis wanted to improve the clinical design or collect additional preclinical data. Further data are eagerly awaited, especially since EMA401 is first-in-class in neuropathic pain.

EMA401: an old antagonist of the AT2R for a new indication in neuropathic pain

PubMed Central

Keppel Hesselink, Jan M; Schatman, Michael E

2017-01-01

EMA401 is an old molecule, synthesized by Parke-Davis in the last century and characterized at that time as an AT2R antagonist. Professor Maree Smith and her group from the University of Queensland (Australia) patented the drug and many related derivatives and other compounds with high affinity for the AT2R for the indication neuropathic pain in 2004, an example of drug repositioning. After some years of university work, the Australian biotech company Spinifex Pharmaceuticals took over further research and development and characterized the S-enantiomer, code name EMA401, and related compounds in a variety of animal models for neuropathic and cancer pain. EMA401 was selected as the lead compound, based on high selectivity for the AT2R and good oral bioavailability (33%). EMA401, however, was only administered once in a chronic neuropathic pain model, and no data have been published in other pain models, or during steady state, although such data were available for the racemate EMA400 and some related compounds (EMA200, EMA400). A pilot phase IIa study demonstrated the efficacy and safety of the drug taken twice daily as two capsules of 50 mg (400 mg/day). In 2015, Novartis took over the clinical development. Two phase IIb studies designed by Spinifex Pharmaceuticals were put on hold, probably because Novartis wanted to improve the clinical design or collect additional preclinical data. Further data are eagerly awaited, especially since EMA401 is first-in-class in neuropathic pain. PMID:28255254

A Mobile Ecological Momentary Assessment Tool (devilSPARC) for Nutrition and Physical Activity Behaviors in College Students: A Validation Study.

PubMed

Bruening, Meg; van Woerden, Irene; Todd, Michael; Brennhofer, Stephanie; Laska, Melissa N; Dunton, Genevieve

2016-07-27

The majority of nutrition and physical activity assessments methods commonly used in scientific research are subject to recall and social desirability biases, which result in over- or under-reporting of behaviors. Real-time mobile-based ecological momentary assessments (mEMAs) may result in decreased measurement biases and minimize participant burden. The aim was to examine the validity of a mEMA methodology to assess dietary and physical activity levels compared to 24-hour dietary recalls and accelerometers. This study was a pilot test of the SPARC (Social impact of Physical Activity and nutRition in College) study, which aimed to determine the mechanism by which friendship networks impact weight-related behaviors among young people. An mEMA app, devilSPARC, was developed to assess weight-related behaviors in real time. A diverse sample of 109 freshmen and community mentors attending a large southwestern university downloaded the devilSPARC mEMA app onto their personal mobile phones. Participants were prompted randomly eight times per day over the course of 4 days to complete mEMAs. During the same 4-day period, participants completed up to three 24-hour dietary recalls and/or 4 days of accelerometry. Self-reported mEMA responses were compared to 24-hour dietary recalls and accelerometry measures using comparison statistics, such as match rate, sensitivity and specificity, and mixed model odds ratios, adjusted for within-person correlation among repeated measurements. At the day level, total dietary intake data reported through the mEMA app reflected eating choices also captured by the 24-hour recall. Entrées had the lowest match rate, and fruits and vegetables had the highest match rate. Widening the window of aggregation of 24-hour dietary recall data on either side of the mEMA response resulted in increased specificity and decreased sensitivity. For physical activity behaviors, levels of activity reported through mEMA differed for sedentary versus non-sedentary activity at the day level as measured by accelerometers. The devilSPARC mEMA app is valid for assessing eating behaviors and the presence of sedentary activity at the day level. This mEMA may be useful in studies examining real-time weight-related behaviors.

Factors Predicting Compliance to Ecological Momentary Assessment Among Adolescent Smokers

PubMed Central

2014-01-01

Introduction: Ecological momentary assessments (EMAs) are increasingly used in smoking research to understand contextual and individual differences related to smoking and changes in smoking. To date, there has been little detailed research into the predictors of EMA compliance. However, patterns or predictors of compliance may affect key relationships under investigation and introduce sources of bias in results. The purpose of this study was to investigate predictors of compliance to random prompts among a sample of adolescents who had ever smoked. Methods: Data for this study were drawn from a sample of 461 adolescents (9th and 10th graders at baseline) participating in a longitudinal study of smoking escalation. We examined 2 outcomes: subject-level EMA compliance (overall rate of compliance over a week-long EMA wave), and in-the-moment prompt-level compliance to the most proximal random prompt. We investigated several covariates including gender, race, smoking rate, alcohol use, psychological symptomatology, home composition, mood, social context, time in study, inter-prompt interval, and location. Results: At the overall subject level, higher mean negative affect, smoking rate, alcohol use, and male gender predicted lower compliance with random EMA prompts. At the prompt level, after controlling for significant subject-level predictors of compliance, increased positive affect, being outside of the home, and longer inter-prompt interval predicted lower momentary compliance. Conclusions: This study identifies several factors associated with overall and momentary EMA compliance among a sample of adolescents participating in a longitudinal study of smoking. We also propose a conceptual framework for investigating the contextual and momentary predictors of compliance within EMA studies. PMID:24097816

Using Ecological Momentary Assessment (EMA) to Study Sex Events Among Very High-Risk Men Who Have Sex with Men (MSM).

PubMed

Wray, Tyler B; Kahler, Christopher W; Monti, Peter M

2016-10-01

MSM continue to represent the largest share of new HIV infections in the United States each year due to high infectivity associated with unprotected anal sex. Ecological momentary assessment (EMA) has the potential to provide a unique view of how high-risk sexual events occur in the real world and can impart detailed information about aspects of decision-making, antecedents, and consequences that accompany these events. EMA may also produce more accurate data on sexual behavior by assessing it soon after its occurrence. We conducted a study involving 12 high-risk MSM to explore the acceptability and feasibility of a 30 day, intensive EMA procedure. Results suggest this intensive assessment strategy was both acceptable and feasible to participants. All participants provided response rates to various assessments that approached or were in excess of their targets: 81.0 % of experience sampling assessments and 93.1 % of daily diary assessments were completed. However, comparing EMA reports with a Timeline Followback (TLFB) of the same 30 day period suggested that participants reported fewer sexual risk events on the TLFB compared to EMA, and reported a number of discrepancies about specific behaviors and partner characteristics across the two methods. Overall, results support the acceptability, feasibility, and utility of using EMA to understand sexual risk events among high-risk MSM. Findings also suggest that EMA and other intensive longitudinal assessment approaches could yield more accurate data about sex events.

Clinical Assessment of Affective Instability: Comparing EMA Indices, Questionnaire Reports, and Retrospective Recall

ERIC Educational Resources Information Center

Solhan, Marika B.; Trull, Timothy J.; Jahng, Seungmin; Wood, Phillip K.

2009-01-01

Traditional self-report measures of psychopathology may be influenced by a variety of recall biases. Ecological momentary assessment (EMA) reduces these biases by assessing individuals' experiences as they occur in their natural environments. This study examines the discrepancy between trait questionnaire, retrospective report, and EMA measures of…

A role for the membrane Golgi protein Ema in autophagy.

PubMed

Kim, Sungsu; DiAntonio, Aaron

2012-08-01

Autophagy is a cellular homeostatic response that involves degradation of self-components by the double-membraned autophagosome. The biogenesis of autophagosomes has been well described, but the ensuing processes after autophagosome formation are not clear. In our recent study, we proposed a model in which the Golgi complex contributes to the growth of autophagic structures, and that the Drosophila melanogaster membrane protein Ema promotes this process. In fat body cells of the D. melanogaster ema mutant, the recruitment of the Golgi complex protein Lava lamp (Lva) to autophagic structures is impaired and autophagic structures are very small. In addition, in the ema mutant autophagic turnover of SQSTM1/p62 and mitophagy are impaired. Our study not only identifies a role for Ema in autophagy, but also supports the hypothesis that the Golgi complex may be a potential membrane source for the biogenesis and development of autophagic structures.

Convergent Validity of Preschool Children's Television Viewing Measures among Low-Income Latino Families: A Cross-Sectional Study

PubMed Central

McLeod, Jessica; Chen, Tzu-An; Nicklas, Theresa A.; Baranowski, Tom

2013-01-01

Abstract Background Television viewing is an important modifiable risk factor for childhood obesity. However, valid methods for measuring children's TV viewing are sparse and few studies have included Latinos, a population disproportionately affected by obesity. The goal of this study was to test the reliability and convergent validity of four TV viewing measures among low-income Latino preschool children in the United States. Methods Latino children (n=96) ages 3–5 years old were recruited from four Head Start centers in Houston, Texas (January, 2009, to June, 2010). TV viewing was measured concurrently over 7 days by four methods: (1) TV diaries (parent reported), (2) sedentary time (accelerometry), (3) TV Allowance (an electronic TV power meter), and (4) Ecological Momentary Assessment (EMA) on personal digital assistants (parent reported). This 7-day procedure was repeated 3–4 weeks later. Test–retest reliability was determined by intraclass correlations (ICC). Spearman correlations (due to nonnormal distributions) were used to determine convergent validity compared to the TV diary. Results The TV diary had the highest test–retest reliability (ICC=0.82, p<0.001), followed by the TV Allowance (ICC=0.69, p<0.001), EMA (ICC=0.46, p<0.001), and accelerometry (ICC=0.36–0.38, p<0.01). The TV Allowance (r=0.45–0.55, p<0.001) and EMA (r=0.47–0.51, p<0.001) methods were significantly correlated with TV diaries. Accelerometer-determined sedentary minutes were not correlated with TV diaries. The TV Allowance and EMA methods were significantly correlated with each other (r=0.48–0.53, p<0.001). Conclusions The TV diary is feasible and is the most reliable method for measuring US Latino preschool children's TV viewing. PMID:23270534

Mass Screening for Celiac Disease Among School-aged Children: Toward Exploring Celiac Iceberg in Saudi Arabia.

PubMed

Al-Hussaini, Abdulrahman; Troncone, Riccardo; Khormi, Musa; AlTuraiki, Muath; Alkhamis, Wahid; Alrajhi, Mona; Halal, Thana; Fagih, Mosa; Alharbi, Sahar; Bashir, Muhammed Salman; Chentoufi, Aziz Alami

2017-12-01

We conducted this mass screening study to determine the prevalence of celiac disease (CD) and characterize the celiac iceberg among Saudi pediatric population in Riyadh, the capital city of Saudi Arabia. During the study period (January 2014-June 2016), we have conducted a cross-sectional, mass screening, immunoglobulin A-tissue transglutaminase (TTG-IgA)-based study on 7930 Saudi students from primary and intermediate schools in Riyadh. Students with positive TTG-IgA (>20 U/L) were called in the hospital to undergo a repeat of TTG-IgA; in those with borderline positive TTG-IgA (20-60 U/L), IgA-endomyseal antibody (EMA-IgA) test was performed. Children with TTG-IgA >60 U/L and children with borderline positive TTG-IgA and positive EMA-IgA were advised to undergo upper endoscopy and intestinal biopsies. We identified 221 students with positive TTG-IgA (2.8%). CD was diagnosed in 119 cases (1.5%, 1:67 Saudi children) (mean age 11.5 ± 2.62 years; girls 81 [68%]). Another 51 children had persistently borderline positive TTG-IgA but negative EMA (0.64%) and the remaining 51 had transiently positive TTG-IgA. We have identified 3 clinical patterns in the screening-identified cases with CD: a silent form (37%), a mild symptomatic form characterized by gastrointestinal symptoms in presence of normal growth or overweight/obesity (48%), and gastrointestinal symptoms associated with impaired growth in 15%. Our study provided evidence of a high prevalence of CD among Saudi children (1.5%), a rate that is at least twice the average prevalence rate in Europe and North America.

[Testosterone replacement therapy and cardiovascular risk].

PubMed

Corona, Giovanni; Dicuio, Mauro; Rastrelli, Giulia; Sforza, Alessandra; Maggi, Mario

2017-11-01

Late onset hypogonadism (LOH) is the most commonly used term to indicate the age-dependent reduction of testosterone. Sexual dysfunction represents the most important determinant for medical consultation and the most specific symptoms associated with LOH. In particular, data from the European Male Ageing Study (EMAS), a population-based survey on more than 3400 subjects, recognized that a triad of sexual symptoms (low libido and reduced spontaneous and sex-related erections) is the only syndromic association with decreased testosterone levels. Accordingly, a meta-analysis of the available randomized controlled trials documented that testosterone therapy (TTh) is able to improve all aspects of sexual function when compared to placebo. Despite this evidence, however, the relative clinical significance and the potential benefit of TTh in LOH are still the subject of strong criticisms in the scientific community. The debate is further complicated by the recent position statement of the US Food and Drug Administration (FDA) emphasizing a possible increased cardiovascular risk of TTh. However, this position was not endorsed by the European Medicines Association (EMA), which reached an opposite position after a specific review of the available data. In this review, all the conflicting data supporting the different positions of the FDA and EMA will be discussed. In particular, data derived from either population-based studies or interventional trials will be analyzed in detail. Although some evidence suggests an increase in TTh-related cardiovascular risk, the data derived from controlled trials do not support this position especially when the incidence of major adverse cardiovascular events are considered. Symptomatic men with documented reduced testosterone levels can be safely treated with TTh.

An immunohistochemical study of primary signet-ring cell carcinoma of the stomach and colorectum: III. expressions of EMA, CEA, CA19-9, CDX-2, p53, Ki-67 antigen, TTF-1, vimentin, and p63 in normal mucosa and in 42 cases

PubMed Central

Terada, Tadashi

2013-01-01

There have no comprehensive immunohistochemical studies of primary signet ring cell carcinoma (SRCC) in the stomach and colorectum. The author examined the expression of nine common antigens (EMA, CEA, CA19-9, CDX-2, p53, Ki-67 antigen, TTF-1, vimentin, and p63) in the non-tumorous normal epithelium of the stomach and colorectum and in 42 cases of primary SRCC of the stomach (30 cases) and colorectum (12 cases). The normal epithelium of the stomach and colon consistently (100%) expressed EMA, CEA, CA19-9, CDX-2, and Ki-67 (labeling <15%). Normal epithelium of these locations never expressed p53, TTF-1, vimentin, and p63. In the primary gastric SRCC, the expression percentage of EMA was 57% (17/30), CEA 100% (30/30), CA19-9 100% (30/30), CDX-2 43% (13/30), p53 83% (25/30), Ki-67 100% (30/30) (labeling index= 36 ± 23 %), TTF-1 0% (0/30), vimentin 0% (0/30), and p63 0% (0/30). In primary colorectal SRCC, the expression percentage of EMA was 25% (3/12), CEA 100% (12/12), CA19-9 100% (12/12), CDX-2 93% (28/30), p53 75% (9/12), Ki-67 100% (30/30) (labeling index= 47% ± 26 %), TTF-1 0% (0/12), vimentin 0% (0/12), and p63 0% (0/12). A comparative statistical analysis showed significant difference in EMA (gastric SRCC 57% vs colorectal SRCC 25%) and CDX-2 (43% vs 93%). There were no significant differences in the other seven antigens’ expression between primary gastric SRCC and primary colorectal SRCC. These findings provide much knowledge of primary SRCC of the stomach and colorectum. The data indicated primary gastric SRCC frequently express EMA but not CDX-2 whereas primary colorectal SRCC frequently express CDX-2 but not EMA. These findings also suggest that EMA and CDX-2 are down-regulated during the gastric SRCC carcinogenesis. This down regulations may be associated with the malignant transformation of gastric SRCC. The data of colorectal SRCC suggest EMA is markedly down-regulated and also suggest that this EMA down-regulation may be associated with the carcinogenesis of colorectal SRCC. The expression pattern of EMA and CDX-2 may be useful in differential diagnosis between primary gastric SRCC and primary colorectal SRCC in the metastatic sites of SRCC. PMID:23573309

Developmental Changes in the Variability of Tongue and Lip Movements during Speech from Childhood to Adulthood: An EMA Study

ERIC Educational Resources Information Center

Murdoch, Bruce E.; Cheng, Hei-Yan; Goozee, Justine V.

2012-01-01

This study investigated the developmental variability of lip and tongue movement in 48 children and adults. Motion of the tongue-tip, tongue-body and lower lip was recorded using electromagnetic articulography during productions of sentences containing /t/, /s/, /l/, /k/ and /p/. Four groups of speakers participated in the study: (1) aged 6-7…

Evaluation of Ecological Momentary Assessment for Tinnitus Severity.

PubMed

Goldberg, Rachel L; Piccirillo, Marilyn L; Nicklaus, Joyce; Skillington, Andrew; Lenze, Eric; Rodebaugh, Thomas L; Kallogjeri, Dorina; Piccirillo, Jay F

2017-07-01

Existing patient-reported outcome measures of tinnitus assess the severity and disability retrospectively, which may result in adequate reliability, but cannot capture the fluctuating and individualized nature of tinnitus. Experience sampling may provide an alternative. To use an ecological momentary assessment (EMA) to measure tinnitus disability and associated constructs. Forty adults with tinnitus provided self-report of their tinnitus bother using 5 questions measured by EMA, as well as standard retrospective outcome measures. In this 6-week longitudinal observational study conducted from July 15 to December 22, 2014, participants provided EMA data for 2 weeks (part 1); then after a 2-week break, they provided EMA data for an additional 2 weeks (part 2). A text message with a link to the EMA survey was sent for a total of 56 assessments during each 2-week assessment period. Ecological momentary assessment responses were evaluated using multilevel confirmatory factor analysis to assess the fluctuating nature of bothersome tinnitus across the group and within the pool of individuals over time. Ecological momentary assessment questions measured tinnitus disability and associated constructs. Compliance in each study part was assessed based on response rates. The Tinnitus Functional Index and the Overall Global Rating of Bother Scale were assessed at the beginning and end of each 2-week assessment period to explore the effect of the frequent EMAs on the perceived level of bother from tinnitus. Of the 40 participants in the study (10 women and 30 men; mean [SD] age, 60.0 [10.5] years), the median survey response rate was high (49 responses to 56 surveys sent [88%] for part 1 and 47 responses of 56 surveys sent [84%] for part 2). The latent factor identified by the 2-level confirmatory factor analysis models demonstrates that within-individual tinnitus bother, loudness, and stress vary together over time. In addition, tinnitus bother, feeling, and stress symptoms all vary together across individuals, which means that bother and stress covary strongly both across time and across individuals. Ecological momentary assessment evaluates the moment-to-moment perception of tinnitus and the effect of emotional and environmental factors, which suggests that it is a superior tool to measure tinnitus outcomes compared with standard retrospective self-reports. Taken together, information from emotional and environmental factors can be summarized in an underlying (latent) factor that represents a vulnerability to bothersome tinnitus and that can be used to comprehensively describe the tinnitus experience. Momentary variability in tinnitus bother is strongly associated with levels of perceived stress.

Providing experiential information on early medical abortion: a qualitative evaluation of an animated personal account, Lara's Story.

PubMed

Sherman, Sarah; Harden, Jeni; Cattanach, Dawn; Cameron, Sharon T

2017-10-01

An animated film has been created to provide information to women requesting early medical abortion (EMA). The 9 min film, Lara's Story , was created using one woman's personal account of her experience. This study evaluated the views of women who had recently undergone EMA on the film and its potential usefulness in providing experiential information to women requesting EMA. Women who had undergone EMA within the past month were recruited. They were shown the film and interviewed in a semi-structured style. Interviews were recorded and transcribed verbatim. They were analysed using cross-sectional indexing and thematic analysis with an inductive approach. 13 women were interviewed. All reported that the film gave a realistic account of EMA and most agreed that they would have wanted to watch it before EMA had it been available. Some said that it might help women who were struggling with decision-making with regard to EMA and all said that there should be unrestricted access to the film from the website of the abortion service. The women commented that the animated style of the film allowed all groups of women to relate to the story. Some commented that Lara's experience of pain, bleeding and side effects such as nausea differed from their own and therefore felt that it would be useful to make more than one woman's account available. The availability of animated audiovisual films recounting women's experiences of EMA might be a valuable adjunct to clinical information for women seeking EMA. © Faculty of Sexual and Reproductive Healthcare of the Royal College of Obstetricians and Gynaecologists (unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

A bioinformatics prediction approach towards analyzing the glycosylation, co-expression and interaction patterns of epithelial membrane antigen (EMA/MUC1)

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

Kalra, Rajkumar S., E-mail: renu-wadhwa@aist.go.jp; Wadhwa, Renu, E-mail: renu-wadhwa@aist.go.jp

2015-02-27

Epithelial membrane antigen (EMA or MUC1) is a heavily glycosylated, type I transmembrane glycoprotein commonly expressed by epithelial cells of duct organs. It has been shown to be aberrantly glycosylated in several diseases including cancer. Protein sequence based annotation and analysis of glycosylation profile of glycoproteins by robust computational and comprehensive algorithms provides possible insights to the mechanism(s) of anomalous glycosylation. In present report, by using a number of bioinformatics applications we studied EMA/MUC1 and explored its trans-membrane structural domain sequence that is widely subjected to glycosylation. Exploration of different extracellular motifs led to prediction of N and O-linked glycosylationmore » target sites. Based on the putative O-linked target sites, glycosylated moieties and pathways were envisaged. Furthermore, Protein network analysis demonstrated physical interaction of EMA with a number of proteins and confirmed its functional involvement in cell growth and proliferation pathways. Gene Ontology analysis suggested an involvement of EMA in a number of functions including signal transduction, protein binding, processing and transport along with glycosylation. Thus, present study explored potential of bioinformatics prediction approach in analyzing glycosylation, co-expression and interaction patterns of EMA/MUC1 glycoprotein.« less

Using Ecological Momentary Assessment to Study Tobacco Behavior in Urban India: There's an App for That.

PubMed

Soong, Andrea; Chen, Julia Cen; Borzekowski, Dina Lg

2015-06-24

Ecological momentary assessment (EMA) uses real-time data collection to assess participants' behaviors and environments. This paper explores the strengths and limitations of using EMA to examine social and environmental exposure to tobacco in urban India among older adolescents and adults. Objectives of this study were (1) to describe the methods used in an EMA study of tobacco use in urban India using a mobile phone app for data collection, (2) to determine the feasibility of using EMA in the chosen setting by drawing on participant completion and compliance rates with the study protocol, and (3) to provide recommendations on implementing mobile phone EMA research in India and other low- and middle-income countries. Via mobile phones and the Internet, this study used two EMA surveys: (1) a momentary survey, sent multiple times per day at random to participants, which asked about their real-time tobacco use (smoked and smokeless) and exposure to pro- and antitobacco messaging in their location, and 2) an end-of-day survey sent at the end of each study day. Trained participants, from Hyderabad and Kolkata, India, reported on their social and environmental exposure to tobacco over 10 consecutive days. This feasibility study examined participant compliance, exploring factors related to the successful completion of surveys and the validity of EMA data. The sample included 205 participants, the majority of whom were male (135/205, 65.9%). Almost half smoked less than daily (56/205, 27.3%) or daily (43/205, 21.0%), and 4.4% (9/205) used smokeless tobacco products. Participants completed and returned 46.87% and 73.02% of momentary and end-of-day surveys, respectively. Significant predictors of momentary survey completion included employment and completion of end-of-day surveys. End-of-day survey completion was only significantly predicted by momentary survey completion. This first study of EMA in India offers promising results, although more research is needed on how to increase compliance. End-of-day survey completion, which has a lower research burden, may be the more appropriate approach to understanding behaviors such as tobacco use within vulnerable populations in challenging locations. Compliance may also be improved by increasing the number of study visits, compliance checks, or opportunities for retraining participants before and during data collection.

Using Ecological Momentary Assessment to Study Tobacco Behavior in Urban India: There’s an App for That

PubMed Central

2015-01-01

Background Ecological momentary assessment (EMA) uses real-time data collection to assess participants’ behaviors and environments. This paper explores the strengths and limitations of using EMA to examine social and environmental exposure to tobacco in urban India among older adolescents and adults. Objective Objectives of this study were (1) to describe the methods used in an EMA study of tobacco use in urban India using a mobile phone app for data collection, (2) to determine the feasibility of using EMA in the chosen setting by drawing on participant completion and compliance rates with the study protocol, and (3) to provide recommendations on implementing mobile phone EMA research in India and other low- and middle-income countries. Methods Via mobile phones and the Internet, this study used two EMA surveys: (1) a momentary survey, sent multiple times per day at random to participants, which asked about their real-time tobacco use (smoked and smokeless) and exposure to pro- and antitobacco messaging in their location, and 2) an end-of-day survey sent at the end of each study day. Trained participants, from Hyderabad and Kolkata, India, reported on their social and environmental exposure to tobacco over 10 consecutive days. This feasibility study examined participant compliance, exploring factors related to the successful completion of surveys and the validity of EMA data. Results The sample included 205 participants, the majority of whom were male (135/205, 65.9%). Almost half smoked less than daily (56/205, 27.3%) or daily (43/205, 21.0%), and 4.4% (9/205) used smokeless tobacco products. Participants completed and returned 46.87% and 73.02% of momentary and end-of-day surveys, respectively. Significant predictors of momentary survey completion included employment and completion of end-of-day surveys. End-of-day survey completion was only significantly predicted by momentary survey completion. Conclusions This first study of EMA in India offers promising results, although more research is needed on how to increase compliance. End-of-day survey completion, which has a lower research burden, may be the more appropriate approach to understanding behaviors such as tobacco use within vulnerable populations in challenging locations. Compliance may also be improved by increasing the number of study visits, compliance checks, or opportunities for retraining participants before and during data collection. PMID:26109369

Children with multiple sclerosis should not become therapeutic hostages

PubMed Central

Rose, Klaus; Müller, Thomas

2016-01-01

Background: Both the United States (US) Food and Drug Administration (FDA) and the European Union (EU) European Medicines Agency (EMA) order pediatric clinical trials as a condition for approval of new compounds. We evaluate clinical value and likelihood of sufficient recruitment for pediatric multiple sclerosis (pMS) studies and discuss US and EU pediatric legislation with pMS as a paradigm. Methods: We analyzed pMS clinical trials requested by the FDA and the EMA and industry-sponsored pMS studies registered on www.clinicaltrials.gov and www.clinicaltrialsregister.eu. Results: The FDA demands four and the EMA 15 pMS trials Conclusions: pMS is rare. Neither FDA nor EMA prioritize compounds for potential benefit in pMS. The EMA in particular orders multiple pMS studies, which will probably not recruit enough patients. Therefore, it is likely that the pMS trial outcomes will not be relevant for evidence-based medicine analyses, clinical practice and a pMS label for the respective drug. EMA requests for multiple pediatric studies have been described in metastasized adolescent melanoma, another very rare pediatric disease. The terms ‘ghost studies’ and ‘therapeutic hostages’ have been proposed for such trials and children whose parents are lured into permitting study participation. Clinical studies are not ethical if the probability is high that they will not provide reasonable outcomes. For now, pMS clinicians will have to continue to use new MS drugs in children off-label. They might consider a more proactive international coordinating role in prioritizing and testing new MS compounds in children. PMID:27582894

Outpatient treatment of acute poisonings in Oslo: poisoning pattern, factors associated with hospitalization, and mortality

PubMed Central

2012-01-01

Background Most patients with acute poisoning are treated as outpatients worldwide. In Oslo, these patients are treated in a physician-led outpatient clinic with limited diagnostic and treatment resources, which reduces both the costs and emergency department overcrowding. We describe the poisoning patterns, treatment, mortality, factors associated with hospitalization and follow-up at this Emergency Medical Agency (EMA, "Oslo Legevakt"), and we evaluate the safety of this current practice. Methods All acute poisonings in adults (> or = 16 years) treated at the EMA during one year (April 2008 to April 2009) were included consecutively in an observational study design. The treating physicians completed a standardized form comprising information needed to address the study's aims. Multivariate logistic regression analysis was used to identify the factors associated with hospitalization. Results There were 2348 contacts for 1856 individuals; 1157 (62%) were male, and the median age was 34 years. The most frequent main toxic agents were ethanol (43%), opioids (22%) and CO or fire smoke (10%). The physicians classified 73% as accidental overdoses with substances of abuse taken for recreational purposes, 15% as other accidents (self-inflicted or other) and 11% as suicide attempts. Most (91%) patients were treated with observation only. The median observation time until discharge was 3.8 hours. No patient developed sequelae or died at the EMA. Seventeen per cent were hospitalized. Gamma-hydroxybutyric acid, respiratory depression, paracetamol, reduced consciousness and suicidal intention were factors associated with hospitalization. Forty-eight per cent were discharged without referral to follow-up. The one-month mortality was 0.6%. Of the nine deaths, five were by new accidental overdose with substances of abuse. Conclusions More than twice as many patients were treated at the EMA compared with all hospitals in Oslo. Despite more than a doubling of the annual number of poisoned patients treated at the EMA since 2003, there was no mortality or sequelae, indicating that the current practice is safe. Thus, most low- to intermediate-acuity poisonings can be treated safely without the need to access hospital resources. Although the short-term mortality was low, more follow-up of patients with substance abuse should be encouraged. PMID:22217253

Waking Up on the Wrong Side of the Bed: The Effects of Stress Anticipation on Working Memory in Daily Life.

PubMed

Hyun, Jinshil; Sliwinski, Martin J; Smyth, Joshua M

2018-05-15

The aim of this study was to examine the association between stress anticipated for the upcoming day and cognitive function later on that day, and how this relationship differed across age. A diverse adult community sample (N = 240, age 25-65 years) completed ecological momentary assessment (EMA) reports for 2 weeks on a smartphone; each day they completed a morning survey upon waking, beeped surveys at five times during a day, and an end-of-day survey. Morning and end-of-day surveys included questions to measure stress anticipation, and each beeped survey included measures of stressful events, followed by a spatial working memory (WM) task. Results from multilevel models indicated that stress anticipation reported upon waking, but not on the previous night, was associated with deficit in WM performance later that day; importantly, this effect was over and above the effect of EMA-reported stress. The detrimental effect of stress anticipation upon waking was invariant across age. These findings suggest that anticipatory processes can produce harmful effects on cognitive functioning that are independent of everyday stress experiences. This may identify an important avenue to mitigate everyday cognitive lapses among older adults.

Economically motivated adulteration (EMA) of food: common characteristics of EMA incidents.

PubMed

Everstine, Karen; Spink, John; Kennedy, Shaun

2013-04-01

Economically motivated adulteration (EMA) of food, also known as food fraud, is the intentional adulteration of food for financial advantage. A common form of EMA, undeclared substitution with alternative ingredients, is usually a health concern because of allergen labeling requirements. As demonstrated by the nearly 300,000 illnesses in China from melamine adulteration of infant formula, EMA also has the potential to result in serious public health consequences. Furthermore, EMA incidents reveal gaps in quality assurance testing methodologies that could be exploited for intentional harm. In contrast to foodborne disease outbreaks, EMA incidents present a particular challenge to the food industry and regulators because they are deliberate acts that are intended to evade detection. Large-scale EMA incidents have been described in the scientific literature, but smaller incidents have been documented only in media sources. We reviewed journal articles and media reports of EMA since 1980. We identified 137 unique incidents in 11 food categories: fish and seafood (24 incidents), dairy products (15), fruit juices (12), oils and fats (12), grain products (11), honey and other natural sweeteners (10), spices and extracts (8), wine and other alcoholic beverages (7), infant formula (5), plant-based proteins (5), and other food products (28). We identified common characteristics among the incidents that may help us better evaluate and reduce the risk of EMA. These characteristics reflect the ways in which existing regulatory systems or testing methodologies were inadequate for detecting EMA and how novel detection methods and other deterrence strategies can be deployed. Prevention and detection of EMA cannot depend on traditional food safety strategies. Comprehensive food protection, as outlined by the Food Safety Modernization Act, will require innovative methods for detecting EMA and for targeting crucial resources toward the riskiest food products.

Combining Standard Conventional Measures and Ecological Momentary Assessment of Depression, Anxiety and Coping Using Smartphone Application in Minor Stroke Population: A Longitudinal Study Protocol

PubMed Central

Vansimaeys, Camille; Zuber, Mathieu; Pitrat, Benjamin; Join-Lambert, Claire; Tamazyan, Ruben; Farhat, Wassim; Bungener, Catherine

2017-01-01

Context: Stroke has several consequences on survivors’ daily life even for those who experience short-lasting neurological symptoms with no functional disability. Depression and anxiety are common psychological disorders occurring after a stroke. They affect long-term outcomes and quality of life but they are difficult to diagnose because of the neurobiological consequences of brain lesions. Current research priority is given to the improvement of the detection and prevention of those post-stroke psychological disorders. Although previous studies have brought promising perspectives, their designs based on retrospective tools involve some limits regarding their ecological validity. Ecological Momentary Assessment (EMA) is an alternative to conventional instruments that could be a key in research for understanding processes that underlined post-stroke depression and anxiety onset. We aim to evaluate the feasibility and validity of anxiety, depression and coping EMA for minor stroke patients. Methods: Patients hospitalized in an Intensive Neuro-vascular Care Unit between April 2016 and January 2017 for a minor stroke is involved in a study based on an EMA methodology. We use a smartphone application in order to assess anxiety and depression symptoms and coping strategies four times a day during 1 week at three different times after stroke (hospital discharge, 2 and 4 months). Participants’ self-reports and clinician-rates of anxiety, depression and coping are collected simultaneously using conventional and standard instruments. Feasibility of the EMA method will be assessed considering the participation and compliance rate. Validity will be the assessed by comparing EMA and conventional self-report and clinician-rated measures. Discussion: We expect this study to contribute to the development of EMA using smartphone in minor stroke population. EMA method offers promising research perspective in the assessment and understanding of post-stroke psychological disorders. The development of EMA in stroke population could lead to clinical implications such as remotely psychological follow-ups during early supported discharge. Trial registration: European Clinical Trials Database Number 2014-A01937-40 PMID:28747895

Structural architecture of the central Brooks Range foothills, Alaska

USGS Publications Warehouse

Moore, Thomas E.; Potter, Christopher J.; O'Sullivan, Paul B.

2002-01-01

Five structural levels underlie the Brooks Range foothills, from lowest to highest: (1) autochthon, at a depth of ~9 km; (2) Endicott Mountains allochthon (EMA), thickest under the northern Brooks Range (>15 km) and wedging out northward above the autochthon; (3) higher allochthons (HA), with a composite thickness of 1.5+ km, wedging out northward at or beyond the termination of EMA; (4) Aptian-Albian Fortress Mountain Formation (FM), deposited unconformably on deformed EMA and HA and thickening northward into a >7-km-thick succession of deformed turbidites (Torok Formation); (5) gently folded Albian-Cenomanian deltaic deposits (Nanushuk Group). The dominant faulting pattern in levels 2-3 is thin-skinned thrusting and thrust-related folds formed before deposition of Cretaceous strata. These structures are cut by younger steeply south-dipping reverse faults that truncate and juxtapose structural levels 1-4 and expose progressively deeper structural levels to the south. Structural levels 4-5 are juxtaposed along a north-dipping zone of south-vergent folds and thrusts. Stratigraphic and fission-track age data suggest a kinematic model wherein the foothills belt was formed first, by thrusting of HA and EMA as deformational wedges onto the regionally south-dipping authochon at 140-120Ma. After deposition of FM and Torok during mid-Cretaceous hinterland extension and uplift, a second episode of contractional deformation at 60 Ma shortened the older allochthonous deformational wedges (EMA, HA) and overlying strata on north-vergent reverse faults. To the north, where the allochthons wedge out, shortening caused duplexing in the Torok and development of a triangle zone south of the Tuktu escarpment.

An algorithm for computing moments-based flood quantile estimates when historical flood information is available

USGS Publications Warehouse

Cohn, T.A.; Lane, W.L.; Baier, W.G.

1997-01-01

This paper presents the expected moments algorithm (EMA), a simple and efficient method for incorporating historical and paleoflood information into flood frequency studies. EMA can utilize three types of at-site flood information: systematic stream gage record; information about the magnitude of historical floods; and knowledge of the number of years in the historical period when no large flood occurred. EMA employs an iterative procedure to compute method-of-moments parameter estimates. Initial parameter estimates are calculated from systematic stream gage data. These moments are then updated by including the measured historical peaks and the expected moments, given the previously estimated parameters, of the below-threshold floods from the historical period. The updated moments result in new parameter estimates, and the last two steps are repeated until the algorithm converges. Monte Carlo simulations compare EMA, Bulletin 17B's [United States Water Resources Council, 1982] historically weighted moments adjustment, and maximum likelihood estimators when fitting the three parameters of the log-Pearson type III distribution. These simulations demonstrate that EMA is more efficient than the Bulletin 17B method, and that it is nearly as efficient as maximum likelihood estimation (MLE). The experiments also suggest that EMA has two advantages over MLE when dealing with the log-Pearson type III distribution: It appears that EMA estimates always exist and that they are unique, although neither result has been proven. EMA can be used with binomial or interval-censored data and with any distributional family amenable to method-of-moments estimation.

An algorithm for computing moments-based flood quantile estimates when historical flood information is available

NASA Astrophysics Data System (ADS)

Cohn, T. A.; Lane, W. L.; Baier, W. G.

This paper presents the expected moments algorithm (EMA), a simple and efficient method for incorporating historical and paleoflood information into flood frequency studies. EMA can utilize three types of at-site flood information: systematic stream gage record; information about the magnitude of historical floods; and knowledge of the number of years in the historical period when no large flood occurred. EMA employs an iterative procedure to compute method-of-moments parameter estimates. Initial parameter estimates are calculated from systematic stream gage data. These moments are then updated by including the measured historical peaks and the expected moments, given the previously estimated parameters, of the below-threshold floods from the historical period. The updated moments result in new parameter estimates, and the last two steps are repeated until the algorithm converges. Monte Carlo simulations compare EMA, Bulletin 17B's [United States Water Resources Council, 1982] historically weighted moments adjustment, and maximum likelihood estimators when fitting the three parameters of the log-Pearson type III distribution. These simulations demonstrate that EMA is more efficient than the Bulletin 17B method, and that it is nearly as efficient as maximum likelihood estimation (MLE). The experiments also suggest that EMA has two advantages over MLE when dealing with the log-Pearson type III distribution: It appears that EMA estimates always exist and that they are unique, although neither result has been proven. EMA can be used with binomial or interval-censored data and with any distributional family amenable to method-of-moments estimation.

EMA analysis of tongue function in children with dysarthria following traumatic brain injury.

PubMed

Murdoch, Bruce E; Goozée, Justine V

2003-01-01

To investigate the speed and accuracy of tongue movements exhibited by a sample of children with dysarthria following severe traumatic brain injury (TBI) during speech using electromagnetic articulography (EMA). Four children, aged between 12.75-17.17 years with dysarthria following TBI, were assessed using the AG-100 electromagnetic articulography system (Carstens Medizinelektronik). The movement trajectories of receiver coils affixed to each child's tongue were examined during consonant productions, together with a range of quantitative kinematic parameters. The children's results were individually compared against the mean values obtained by a group of eight control children (mean age of 14.67 years, SD 1.60). All four TBI children were perceived to exhibit reduced rates of speech and increased word durations. Objective EMA analysis revealed that two of the TBI children exhibited significantly longer consonant durations compared to the control group, resulting from different underlying mechanisms relating to speed generation capabilities and distances travelled. The other two TBI children did not exhibit increased initial consonant movement durations, suggesting that the vowels and/or final consonants may have been contributing to the increased word durations. The finding of different underlying articulatory kinematic profiles has important implications for the treatment of speech rate disturbances in children with dysarthria following TBI.

Intelligent Control Electromagnetic Actuated Continuously Variable Transmission System for Passenger Car

NASA Astrophysics Data System (ADS)

Rahman, Ataur; Sharif, Sazzad; Mohiuddin, AKM; Faris Ismail, Ahmed; Izan, Sany Ihsan

2017-03-01

Continuously variable transmission (CVT) system transmits the engine /battery power to the car driving wheel smoothly and efficiently. Cars with CVT produces some noise and slow acceleration to meet the car power demand on initial start-ups and slow speed. The car noise is produced as a result of CVT adjustment the engine speed with the hydraulic pressure. The current CVT problems incurred due to the slow response of hydraulic pressure and CVT fluid viscosity due to the development of heat.The aim of this study is to develop electromagnetic actuated CVT (EMA-CVT) with intelligent switching controlling system (ICS). The experimental results of ¼ scale EMA shows that it make the acceleration time of the car in 3.5-5 sec which is 40% less than the hydraulic CVT in the market. The EMA develops the electromagnetic force in the ranged of 350 -1200 N for the supply current in the range of 10-15 amp. This study introduced fuzzy intelligent system (FIS) to predict the EMA system dynamic behaviour in order to identify the current control for the EMA actuation during operation of the CVT. It is expecting that the up scale EMA-CVT would reduce the 75% of vehicle power transmission loss by accelerating vehicle in 5 sec and save the IC engine power consumption about 20% which will makes the vehicle energy efficient (EEV) and reduction of green house gas reduction.

Extended Monopole antenna Array with individual Shield (EMAS) coil: An improved monopole antenna design for brain imaging at 7 tesla MRI.

PubMed

Woo, Myung-Kyun; Hong, Suk-Min; Lee, Jongho; Kang, Chang-Ki; Park, Sung-Yeon; Son, Young-Don; Kim, Young-Bo; Cho, Zang-Hee

2016-06-01

To propose a new Extended Monopole antenna Array with individual Shields (EMAS) coil that improves the B1 field coverage and uniformity along the z-direction. To increase the spatial coverage of Monopole antenna Array (MA) coil, each monopole antenna was shielded and extended in length. Performance of this new coil, which is referred to as EMAS coil, was compared with the original MA coil and an Extended Monopole antenna Array coil with no shield (EMA). For comparison, flip angle, signal-to-noise ratio (SNR), and receive sensitivity maps were measured at multiple regions of interest (ROIs) in the brain. The EMAS coil demonstrated substantially larger flip angle and receive sensitivity than the MA and EMA coils in the inferior aspect of the brain. In the brainstem ROI, for example, the flip angle in the EMAS coil was increased by 45.5% (or 60.0%) and the receive sensitivity was increased by 26.9% (or 14.9%), resulting in an SNR gain of 84.8% (or 76.3%) when compared with the MA coil (or EMA). The EMAS coil provided 25.7% (or 24.4%) more uniform B1+ field distribution compared with the MA (or EMA) coil in sagittal. The EMAS coil successfully extended the imaging volume in lower part of the brain. Magn Reson Med 75:2566-2572, 2016. © 2015 Wiley Periodicals, Inc. © 2015 Wiley Periodicals, Inc.

Neuroticism developmental courses--implications for depression, anxiety and everyday emotional experience; a prospective study from adolescence to young adulthood.

PubMed

Aldinger, Maren; Stopsack, Malte; Ulrich, Ines; Appel, Katja; Reinelt, Eva; Wolff, Sebastian; Grabe, Hans Jörgen; Lang, Simone; Barnow, Sven

2014-08-06

Neuroticism is frequently discussed as a risk factor for psychopathology. According to the maturity principle, neuroticism decreases over the course of life, but not uniformly across individuals. However, the implications of differences in personality maturation on mental health have not been well studied so far. Hence, we hypothesized that different forms of neuroticism development from adolescence to young adulthood are associated with differences in depression, anxiety and everyday emotional experience at the age of 25. A sample of 266 adolescents from the general population was examined three times over ten years (age at T0: 15, T1: 20 and T2: 25) using questionnaires, interviews and ecological momentary assessment (EMA). At all measurement points, neuroticism was assessed with the NEO inventory. At T2, diagnoses of major depression and anxiety disorders were captured with a structured clinical interview (M-CIDI). Phone-based EMA was used to assess emotional experience and affective instability over a two-week period at T2. The best fitting model was a latent class growth analysis with two groups of neuroticism development. Most individuals (n = 205) showed moderate values whereas 61 participants were clustered into a group with elevated neuroticism levels. In both groups neuroticism significantly changed during the ten year period with a peak at the age of 20. Individuals with a higher absolute level were at 14-fold increased risk for depression and 7-fold risk for anxiety disorders at the age of 25. In EMA, increased negative affect and arousal as well as decreased positive emotions were found in this high group. Other than expected, personality did not mature in our sample. However, there was a significant change of neuroticism values from adolescence to young adulthood. Further, over 20% of our participants showed a neuroticism development which was associated with adverse outcomes such as negatively toned emotional experience and a heightened risk to suffer from depressive and anxiety disorders in young adulthood. These high-risk persons need to be identified early to provide interventions supporting continuous personality maturation.

Momentary assessment of adults' physical activity and sedentary behavior: feasibility and validity.

PubMed

Dunton, Genevieve Fridlund; Liao, Yue; Kawabata, Keito; Intille, Stephen

2012-01-01

Mobile phones are ubiquitous and easy to use, and thus have the capacity to collect real-time data from large numbers of people. Research tested the feasibility and validity of an Ecological Momentary Assessment (EMA) self-report protocol using electronic surveys on mobile phones to assess adults' physical activity and sedentary behaviors. Adults (N = 110; 73% female, 30% Hispanic, 62% overweight/obese) completed a 4-day signal-contingent EMA protocol (Saturday-Tuesday) with eight surveys randomly spaced throughout each day. EMA items assessed current activity (e.g., Watching TV/Movies, Reading/Computer, Physical Activity/Exercise). EMA responses were time-matched to minutes of moderate-to-vigorous physical activity (MVPA) and sedentary activity (SA) measured by accelerometer immediately before and after each EMA prompt. Unanswered EMA prompts had greater MVPA (±15 min) than answered EMA prompts (p = 0.029) for under/normal weight participants, indicating that activity level might influence the likelihood of responding. The 15-min. intervals before versus after the EMA-reported physical activity (n = 296 occasions) did not differ in MVPA (p > 0.05), suggesting that prompting did not disrupt physical activity. SA decreased after EMA-reported sedentary behavior (n = 904 occasions; p < 0.05) for overweight and obese participants. As compared with other activities, EMA-reported physical activity and sedentary behavior had significantly greater MVPA and SA, respectively, in the ±15 min of the EMA prompt (ps < 0.001), providing evidence for criterion validity. Findings generally support the acceptability and validity of a 4-day signal-contingent EMA protocol using mobile phones to measure physical activity and sedentary behavior in adults. However, some MVPA may be missed among underweight and normal weight individuals.

Priority review drugs approved by the FDA and the EMA: time for international regulatory harmonization of pharmaceuticals?

PubMed

Alqahtani, Saad; Seoane-Vazquez, Enrique; Rodriguez-Monguio, Rosa; Eguale, Tewodros

2015-07-01

The US Food and Drug Administration (FDA) priority review process applies to a drug that is considered a significant improvement over the available alternatives. The European Medicines Agency (EMA) accelerated approval applies to a product that is of major public health interest. This study assessed differences in the characteristics of priority review new molecular entities and new therapeutic biologic products approved by the FDA and the EMA. This study includes regulatory information on drug applications, approvals, indications, and orphan designations of all priority review drugs approved by the FDA and the EMA in the period 1999-2011. Descriptive statistics, t-tests, and chi-squared and Wilcoxon tests were performed. Overall, 100 FDA priority review new molecular entities and new therapeutic biologics were approved by both agencies; 87.0% of the products were first approved by the FDA. The average FDA review time (9.2 ± 8.4 months) was significantly lower than the EMA average review time (14.6 ± 4.0 months) (p < 0.0001). The FDA and the EMA granted orphan designation to 43.0% and 33.0%, respectively, of the applications. There were differences in the administration route (1.0% of all products), dosage (8.0%), strength (23%), posology (51.0%), indications (30.0%), restrictions of use (52.0%), limitations of use (19.0%), and outcomes limitations (28.0%) approved by both regulatory agencies. Significant differences exist in the characteristics of the priority review drugs approved by the FDA and the EMA. Harmonization of the US and European regulatory frameworks may facilitate timely approval of pharmaceutical products. Copyright © 2015 John Wiley & Sons, Ltd.

Low-cost water-lifting from groundwater sources: a comparison of the EMAS Pump with the Rope Pump

NASA Astrophysics Data System (ADS)

MacCarthy, Michael F.; Carpenter, Jacob D.; Mihelcic, James R.

2017-08-01

In sub-Saharan Africa, low-cost groundwater supply systems offer great opportunities for the current unserved population of >300 million to access drinking water. A comparative study was performed in Uganda of the EMAS Pump (designed by Escuela Móvil Aguas y Saneamiento Básico) with the trade-named Rope Pump, two low-cost manual water-lifting devices appropriate to pumping from shallow groundwater sources. Pumping rates, energy expended, material costs, and construction requirements were analyzed. Focus was on low-cost application for use in shallow groundwater systems at the household level in developing countries, particularly in sub-Saharan Africa. The study site was northern Uganda, with testing performed at several drilled boreholes. Two variants of each pump were tested by a male and female user, pumping from multiple static water-level depths ranging from 5 to 28 m. Results demonstrated the most common version of the EMAS Pump to perform similarly to the comparable version of the Rope Pump in terms of average pumping rate at depth range 5 to 18 m (93-111%), but less so at deeper depths (63-85%). Normalized pumping rates (considering energy expended) accentuated differences between these versions of the EMAS Pump and Rope Pump (47-97%). Cost of materials to construct the EMAS Pump were 21-60% those of the Rope Pump, and EMAS Pump construction requirements were also less. Based on the assessed factors, it is concluded that the EMAS Pump has potential for success in "self-supply" groundwater systems in sub-Saharan Africa and is particularly appropriate to link with low-cost shallow groundwater sources.

A Comparative Review of Waivers Granted in Pediatric Drug Development by FDA and EMA from 2007-2013.

PubMed

Egger, Gunter F; Wharton, Gerold T; Malli, Suzanne; Temeck, Jean; Murphy, M Dianne; Tomasi, Paolo

2016-09-01

The European Union and the United States have different legal frameworks in place for pediatric drug development, which can potentially lead to different pediatric research requirements for the pharmaceutical industry. This manuscript compares pediatric clinical trial waivers granted by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). This is a retrospective review comparing EMA's Paediatric Committee (PDCO) decisions with FDA's Pediatric Review Committee (PeRC) recommendations for all product-specific pediatric full waiver applications submitted to EMA from January 2007 through December 2013. Using baseline data from EMA, we matched product-specific waivers with their FDA equivalents during the study period. For single active substance products, PDCO and PeRC adopted similar opinions in 42 of 49 indications (86%). For fixed-dose combinations, PDCO and PeRC adopted similar opinions in 24 of 31 indications (77%). Despite the different legal frameworks, criteria, and processes of determination, the waiver decisions of the 2 agencies were similar in the majority of cases.

Implementing the Biopharmaceutics Classification System in Drug Development: Reconciling Similarities, Differences, and Shared Challenges in the EMA and US-FDA-Recommended Approaches.

PubMed

Cardot, J-M; Garcia Arieta, A; Paixao, P; Tasevska, I; Davit, B

2016-07-01

The US-FDA recently posted a draft guideline for industry recommending procedures necessary to obtain a biowaiver for immediate-release oral dosage forms based on the Biopharmaceutics Classification System (BCS). This review compares the present FDA BCS biowaiver approach, with the existing European Medicines Agency (EMA) approach, with an emphasis on similarities, difficulties, and shared challenges. Some specifics of the current EMA BCS guideline are compared with those in the recently published draft US-FDA BCS guideline. In particular, similarities and differences in the EMA versus US-FDA approaches to establishing drug solubility, permeability, dissolution, and formulation suitability for BCS biowaiver are critically reviewed. Several case studies are presented to illustrate the (i) challenges of applying for BCS biowaivers for global registration in the face of differences in the EMA and US-FDA BCS biowaiver criteria, as well as (ii) challenges inherent in applying for BCS class I or III designation and common to both jurisdictions.

Virtues, ecological momentary assessment/intervention and smartphone technology.

PubMed

Runyan, Jason D; Steinke, Ellen G

2015-01-01

Virtues, broadly understood as stable and robust dispositions for certain responses across morally relevant situations, have been a growing topic of interest in psychology. A central topic of discussion has been whether studies showing that situations can strongly influence our responses provide evidence against the existence of virtues (as a kind of stable and robust disposition). In this review, we examine reasons for thinking that the prevailing methods for examining situational influences are limited in their ability to test dispositional stability and robustness; or, then, whether virtues exist. We make the case that these limitations can be addressed by aggregating repeated, cross-situational assessments of environmental, psychological and physiological variables within everyday life-a form of assessment often called ecological momentary assessment (EMA, or experience sampling). We, then, examine how advances in smartphone application (app) technology, and their mass adoption, make these mobile devices an unprecedented vehicle for EMA and, thus, the psychological study of virtue. We, additionally, examine how smartphones might be used for virtue development by promoting changes in thought and behavior within daily life; a technique often called ecological momentary intervention (EMI). While EMA/I have become widely employed since the 1980s for the purposes of understanding and promoting change amongst clinical populations, few EMA/I studies have been devoted to understanding or promoting virtues within non-clinical populations. Further, most EMA/I studies have relied on journaling, PDAs, phone calls and/or text messaging systems. We explore how smartphone app technology provides a means of making EMA a more robust psychological method, EMI a more robust way of promoting positive change, and, as a result, opens up new possibilities for studying and promoting virtues.

Combined ecological momentary assessment and global positioning system tracking to assess smoking behavior: a proof of concept study.

PubMed

Mitchell, John T; Schick, Robert S; Hallyburton, Matt; Dennis, Michelle F; Kollins, Scott H; Beckham, Jean C; McClernon, F Joseph

2014-01-01

Ecological momentary assessment (EMA) methods have provided a rich assessment of the contextual factors associated with a wide range of behaviors including alcohol use, eating, physical activity, and smoking. Despite this rich database, this information has not been linked to specific locations in space. Such location information, which can now be easily acquired from global positioning system (GPS) tracking devices, could provide unique information regarding the space-time distribution of behaviors and new insights into their determinants. In a proof of concept study, we assessed the acceptability and feasibility of acquiring and combining EMA and GPS data from adult smokers with attention deficit hyperactivity disorder (ADHD). Participants were adults with ADHD who were enrolled in a larger EMA study on smoking and psychiatric symptoms. Among those enrolled in the latter study who were approached to participate (N = 11), 10 consented, provided daily EMA entries, and carried a GPS device with them during a 7-day assessment period to assess aspects of their smoking behavior. The majority of those eligible to participate were willing to carry a GPS device and signed the consent (10 out of 11, 91%). Of the 10 who consented, 7 participants provided EMA entries and carried the GPS device with them daily for at least 70% of the sampling period. Data are presented on the spatial distribution of smoking episodes and ADHD symptoms on a subset of the sample to demonstrate applications of GPS data. We conclude by discussing how EMA and GPS might be used to study the ecology of smoking and make recommendations for future research and analysis.

Combined Ecological Momentary Assessment and Global Positioning System Tracking to Assess Smoking Behavior: A Proof of Concept Study

PubMed Central

Mitchell, John T.; Schick, Robert S.; Hallyburton, Matt; Dennis, Michelle F.; Kollins, Scott H.; Beckham, Jean C.; McClernon, F. Joseph

2014-01-01

Objective Ecological momentary assessment (EMA) methods have provided a rich assessment of the contextual factors associated with a wide range of behaviors including alcohol use, eating, physical activity, and smoking. Despite this rich database, this information has not been linked to specific locations in space. Such location information, which can now be easily acquired from global positioning system (GPS) tracking devices, could provide unique information regarding the space-time distribution of behaviors and new insights into their determinants. In a proof of concept study, we assessed the acceptability and feasibility of acquiring and combining EMA and GPS data from adult smokers with attention deficit hyperactivity disorder (ADHD). Methods Participants were adults with ADHD who were enrolled in a larger EMA study on smoking and psychiatric symptoms. Among those enrolled in the latter study who were approached to participate (N = 11), 10 consented, provided daily EMA entries, and carried a GPS device with them during a 7-day assessment period to assess aspects of their smoking behavior. Results The majority of those eligible to participate were willing to carry a GPS device and signed the consent (10 out of 11, 91%). Of the 10 who consented, 7 participants provided EMA entries and carried the GPS device with them daily for at least 70% of the sampling period. Data are presented on the spatial distribution of smoking episodes and ADHD symptoms on a subset of the sample to demonstrate applications of GPS data. Conclusions We conclude by discussing how EMA and GPS might be used to study the ecology of smoking and make recommendations for future research and analysis. PMID:24883050

Virtues, ecological momentary assessment/intervention and smartphone technology

PubMed Central

Runyan, Jason D.; Steinke, Ellen G.

2015-01-01

Virtues, broadly understood as stable and robust dispositions for certain responses across morally relevant situations, have been a growing topic of interest in psychology. A central topic of discussion has been whether studies showing that situations can strongly influence our responses provide evidence against the existence of virtues (as a kind of stable and robust disposition). In this review, we examine reasons for thinking that the prevailing methods for examining situational influences are limited in their ability to test dispositional stability and robustness; or, then, whether virtues exist. We make the case that these limitations can be addressed by aggregating repeated, cross-situational assessments of environmental, psychological and physiological variables within everyday life—a form of assessment often called ecological momentary assessment (EMA, or experience sampling). We, then, examine how advances in smartphone application (app) technology, and their mass adoption, make these mobile devices an unprecedented vehicle for EMA and, thus, the psychological study of virtue. We, additionally, examine how smartphones might be used for virtue development by promoting changes in thought and behavior within daily life; a technique often called ecological momentary intervention (EMI). While EMA/I have become widely employed since the 1980s for the purposes of understanding and promoting change amongst clinical populations, few EMA/I studies have been devoted to understanding or promoting virtues within non-clinical populations. Further, most EMA/I studies have relied on journaling, PDAs, phone calls and/or text messaging systems. We explore how smartphone app technology provides a means of making EMA a more robust psychological method, EMI a more robust way of promoting positive change, and, as a result, opens up new possibilities for studying and promoting virtues. PMID:25999869

Acceptability and feasibility of smartphone-assisted 24 h recalls in the Chinese population.

PubMed

Zang, Jiajie; Song, Jun; Wang, Zhengyuan; Yao, Chunxia; Ma, Jianhong; Huang, Cuihua; Zhu, Zhenni; Smith, Lindsey P; Du, Shufa; Hua, Jenna; Seto, Edmund; Popkin, Barry M; Zou, Shurong

2015-12-01

To examine the acceptability and feasibility of using smartphone technology to assess beverage intake and evaluate whether the feasibility of smartphone use is greater among key sub-populations. An acceptability and feasibility study of recording the video dietary record, the acceptability of the ecological momentary assessment (EMA), wearing smartphones and whether the videos helped participants recall intake after a cross-over validation study. Rural and urban area in Shanghai, China. Healthy adults (n 110) aged 20-40 years old. Most participants reported that the phone was acceptable in most aspects, including that videos were easy to use (70%), helped with recalls (77%), EMA reminders helped them record intake (75%) and apps were easy to understand (85%). However, 49% of the participants reported that they had trouble remembering to take videos of the beverages before consumption or 46% felt embarrassed taking videos in front of others. Moreover, 72% reported that the EMA reminders affected their consumption. When assessing overall acceptability of using smartphones, 72% of the participants were favourable responders. There were no statistically significant differences in overall acceptability for overweight v. normal-weight participants or for rural v. urban residents. However, we did find that the overall acceptability was higher for males (81%) than females (61%, P=0·017). Our study did not find smartphone technology helped with dietary assessments in a Chinese population. However, simpler approaches, such as using photographs instead of videos, may be more feasible for enhancing 24 h dietary recalls.

Development of a personal digital assistant (PDA) system to collect symptom information from home hospice patients.

PubMed

Hachizuka, Maki; Yoshiuchi, Kazuhiro; Yamamoto, Yoshiharu; Iwase, Satoru; Nakagawa, Keiichi; Kawagoe, Koh; Akabayashi, Akira

2010-06-01

Previous studies have found that inappropriate assessment of cancer pain can lead to inadequate pain management. To improve assessment, it may be helpful to collect real-time data in a natural environment using computerized ecological momentary assessment (cEMA). Therefore, the aim of the study was to develop a personal digital assistant (PDA) system to collect information on symptoms such as pain and mood states in patients with cancer using cEMA. Following a pilot study in inpatients with cancer, the second phase of the study involved patients with terminal cancer receiving home hospice care. These patients were asked to record their symptoms in a PDA (a palm-sized portable device) several times per day for a week when they took rescue medications and when an alarm sounded. At the end of the week, an interview on the usability of the device was conducted and overall response rates were calculated. Fifteen patients completed the second phase of the study. Their median age was 64 years and the median survival time after the study period was 22 days. The overall response rates were 90.3% to the sound of the alarm and 80.2% after taking rescue medications. The user-friendliness of the device was rated as 8.8 on a scale of 0 (worst) to 10 (best). The cEMA technique using a PDA might be applicable to patients with cancer in palliative care to evaluate symptoms in a natural setting. This system may also be useful for managing symptoms such as pain and mood states in patients with cancer.

EMAS statement: benign accountability or wishful thinking? Insights from the Greek EMAS registry.

PubMed

Skouloudis, Antonis; Jones, Keith; Sfakianaki, Eleni; Lazoudi, Eugenia; Evangelinos, Konstantinos

2013-10-15

Do organizations certified under the Eco-Management and Audit Scheme (EMAS) effectively discharge their environmental accountability through their statements? Is the EMAS statement a step forward for the transparency of environmental management and the empowerment of organizational stakeholders' decision-making? Drawing from the Greek EMAS registry we apply an evaluation method for the completeness and materiality of environmental statements. While the latest version of the EMAS Regulation has introduced a set of forward-looking - yet challenging - improvements, the application of the standard should be closely examined. With this in mind, the key objective of this research note is to provide - from a descriptive standpoint - insights on the content of EMAS-based environmental accountability and a basis for future research as well as fruitful policy debate. Copyright © 2013 Elsevier Ltd. All rights reserved.

Pregnancy outcomes after maternal use of thiocolchicoside: A case series.

PubMed

Kaplan, Yusuf C; Keskin-Arslan, Elif; Küçüksolak, Gözde; Akyol, Fatih; Karadas, Barış; Görgel, Sacit Nuri; Kaya-Temiz, Tijen

2018-03-01

The 2014 report by European Medicines Agency (EMA) restricted the use of thiocolchicoside for all reproductive-age women. In this study, we aim to expand the systematically-collected human data and discuss it within the frame provided by this report. We identified and evaluated the outcomes of 48 prospectively recorded pregnancies referred to Terafar (Teratology Information Service, Izmir, Turkey). Of 42 pregnancies with first-trimester exposure and known outcomes, 31 resulted in live births, four in miscarriage and seven ended with elective terminations. There were 26 normal outcomes, two major and three minor congenital malformations among the live births. Despite a number of limitations, our results and previous case series collectively strengthen the view that thiocolchicoside is unlikely to be a major teratogen. EMA's 2014 report should be revised to reflect this finding, while current restrictions on use should continue until more detailed safety information is available. Copyright © 2018 Elsevier Inc. All rights reserved.

The bidirectional association between daytime affect and nighttime sleep in youth with anxiety and depression.

PubMed

Cousins, Jennifer C; Whalen, Diana J; Dahl, Ronald E; Forbes, Erika E; Olino, Thomas M; Ryan, Neal D; Silk, Jennifer S

2011-10-01

This study examines relationships between affect and sleep in youth with affective disorders using ecological momentary assessment (EMA). Participants included 94 youth, ages 8-16 (M = 11.73, 53% female) years with an anxiety disorder only (n = 23), primary major depressive disorder (with and without a secondary anxiety diagnoses; n = 42), and healthy controls (n = 29). A cell phone EMA protocol assessed affect and actigraphy measured sleep. The patterns of bidirectional relationships between affect and sleep differed across diagnostic groups. Higher daytime positive affect and positive to negative affect ratios were associated with more time in bed during the subsequent night for youth with primary depression and less time in bed for youth with anxiety only. More time asleep was associated with more positive affect for both diagnostic groups the following day. This relationship may be important to consider in the treatment of youth affective disorders.

Ecological Momentary Assessment is a Neglected Methodology in Suicidology.

PubMed

Davidson, Collin L; Anestis, Michael D; Gutierrez, Peter M

2017-01-02

Ecological momentary assessment (EMA) is a group of research methods that collect data frequently, in many contexts, and in real-world settings. EMA has been fairly neglected in suicidology. The current article provides an overview of EMA for suicidologists including definitions, data collection considerations, and different sampling strategies. Next, the benefits of EMA in suicidology (i.e., reduced recall bias, accurate tracking of fluctuating variables, testing assumptions of theories, use in interventions), participant safety considerations, and examples of published research that investigate self-directed violence variables using EMA are discussed. The article concludes with a summary and suggested directions for EMA research in suicidology with the particular aim to spur the increased use of this methodology among suicidologists.

Potential Risks of Ecological Momentary Assessment Among Persons Who Inject Drugs.

PubMed

Roth, Alexis M; Rossi, John; Goldshear, Jesse L; Truong, Quan; Armenta, Richard F; Lankenau, Stephen E; Garfein, Richard S; Simmons, Janie

2017-06-07

Ecological momentary assessment (EMA)-which often involves brief surveys delivered via mobile technology-has transformed our understanding of the individual and contextual micro-processes associated with legal and illicit drug use. However, little empirical research has focused on participant's perspective on the probability and magnitude of potential risks in EMA studies. To garner participant perspectives on potential risks common to EMA studies of illicit drug use. We interviewed 38 persons who inject drugs living in San Diego (CA) and Philadelphia (PA), United States. They completed simulations of an EMA tool and then underwent a semi-structured interview that systematically explored domains of risk considered within the proposed revisions to the Federal Policy for the Protection of Human Subjects or the "Common Rule." Interviews were transcribed verbatim and coded systematically to explore psychological, physical, social, legal, and informational risks from participation. Participants perceived most risks to be minimal. Some indicated that repetitive questioning about mood or drug use could cause psychological (i.e., anxiety) or behavioral risks (i.e., drug use relapse). Ironically, the questions that were viewed as risky were considered motivational to engage in healthy behaviors. The most cited risks were legal and social risks stemming from participant concerns about data collection and security. Improving our understanding of these issues is an essential first step to protect human participants in future EMA research. We provide a brief set of recommendations that can aid in the design and ethics review of the future EMA protocol with substance using populations.

Using smartphones to decrease substance use via self-monitoring and recovery support: study protocol for a randomized control trial.

PubMed

Scott, Christy K; Dennis, Michael L; Gustafson, David H

2017-08-10

Alcohol abuse, other substance use disorders, and risk behaviors associated with the human immunodeficiency virus (HIV) represent three of the top 10 modifiable causes of mortality in the US. Despite evidence that continuing care is effective in sustaining recovery from substance use disorders and associated behaviors, patients rarely receive it. Smartphone applications (apps) have been effective in delivering continuing care to patients almost anywhere and anytime. This study tests the effectiveness of two components of such apps: ongoing self-monitoring through Ecological Momentary Assessments (EMAs) and immediate recovery support through Ecological Momentary Interventions (EMIs). The target population, adults enrolled in substance use disorder treatment (n = 400), are being recruited from treatment centers in Chicago and randomly assigned to one of four conditions upon discharge in a 2 × 2 factorial design. Participants receive (1) EMAs only, (2) EMIs only, (3) combined EMAs + EMIs, or (4) a control condition without EMA or EMI for 6 months. People in the experimental conditions receive smartphones with the apps (EMA and/or EMI) specific to their condition. Phones alert participants in the EMA and EMA + EMI conditions at five random times per day and present participants with questions about people, places, activities, and feelings that they experienced in the past 30 min and whether these factors make them want to use substances, support their recovery, or have no impact. Those in the EMI and EMA + EMI conditions have continual access to a suite of support services. In the EMA + EMI condition, participants are prompted to use the EMI(s) when responses to the EMA(s) indicate risk. All groups have access to recovery support as usual. The primary outcome is days of abstinence from alcohol and other drugs. Secondary outcomes are number of HIV risk behaviors and whether abstinence mediates the effects of EMA, EMI, or EMA + EMI on HIV risk behaviors. This project will enable the field to learn more about the effects of EMAs and EMIs on substance use disorders and HIV risk behaviors, an understanding that could potentially make treatment and recovery more effective and more widely accessible. ClinicalTrials.gov, ID: NCT02132481 . Registered on 5 May 2014.

Conceptualizing and Estimating Process Speed in Studies Employing Ecological Momentary Assessment Designs: A Multilevel Variance Decomposition Approach

ERIC Educational Resources Information Center

Shiyko, Mariya P.; Ram, Nilam

2011-01-01

Researchers have been making use of ecological momentary assessment (EMA) and other study designs that sample feelings and behaviors in real time and in naturalistic settings to study temporal dynamics and contextual factors of a wide variety of psychological, physiological, and behavioral processes. As EMA designs become more widespread,…

Differences in stress-related ratings between research center and home environments in dementia caregivers using ecological momentary assessment

PubMed Central

Fonareva, Irina; Amen, Alexandra M.; Ellingson, Roger M.; Oken, Barry S.

2012-01-01

Background Clinicians and researchers working with dementia caregivers typically assess caregiver stress in a clinic or research center, but caregivers’ stress is rooted at home where they provide care. The study aimed to compare ratings of stress-related measures obtained in research setting and home using ecological momentary assessment (EMA). Methods EMA of 18 caregivers (mean age 66.4±7.8, 89% females) and 23 non-caregivers (mean age 66.4±7.9, 87% females) was implemented using a personal digital assistant. Subjects rated their perceived stress, fatigue, coping with current situation, mindfulness, and situational demand once in the research center and again at 3–4 semi-random points during a day at home. The data from several assessments conducted at home were averaged for statistical analyses and compared to the data collected in the research center. Results Testing environment had a differential effect on caregivers and non-caregivers for the ratings of perceived stress (p < 0.01) and situational demand (p = 0.01). When tested in research center, ratings for all measures were similar between groups, but when tested at home, caregivers rated their perceived stress higher than non-caregivers (p = 0.02). Overall, caregivers reported higher perceived stress at home than in the research center (p = 0.02), and non-caregivers reported greater situational demand in the research center than at home (p < 0.01). Conclusions The assessment method and environment affect stress-related outcomes. Evaluating participants in their natural environment provides a more sensitive measure of stress-related outcomes. EMA provides a convenient way to gather data when evaluating dementia caregivers. PMID:21777503

Differences in stress-related ratings between research center and home environments in dementia caregivers using ecological momentary assessment.

PubMed

Fonareva, Irina; Amen, Alexandra M; Ellingson, Roger M; Oken, Barry S

2012-01-01

Clinicians and researchers working with dementia caregivers typically assess caregiver stress in a clinic or research center, but caregivers' stress is rooted at home where they provide care. This study aimed to compare ratings of stress-related measures obtained in research settings and in the home using ecological momentary assessment (EMA). EMA of 18 caregivers (mean age 66.4 years ±7.8; 89% females) and 23 non-caregivers (mean age 66.4 years ±7.9; 87% females) was implemented using a personal digital assistant. Subjects rated their perceived stress, fatigue, coping with current situation, mindfulness, and situational demand once in the research center and again at 3-4 semi-random points during a day at home. The data from several assessments conducted at home were averaged for statistical analyses and compared with the data collected in the research center. The testing environment had a differential effect on caregivers and non-caregivers for the ratings of perceived stress (p < 0.01) and situational demand (p = 0.01). When tested in the research center, ratings for all measures were similar between groups, but when tested at home, caregivers rated their perceived stress as higher than non-caregivers (p = 0.02). Overall, caregivers reported higher perceived stress at home than in the research center (p = 0.02), and non-caregivers reported greater situational demand in the research center than at home (p < 0.01). The assessment method and environment affect stress-related outcomes. Evaluating participants in their natural environment provides a more sensitive measure of stress-related outcomes. EMA provides a convenient way to gather data when evaluating dementia caregivers.

Ecological Momentary Assessment of Negative Symptoms in Schizophrenia: Relationships to Effort Based Decision Making and Reinforcement Learning

PubMed Central

Moran, Erin K.; Culbreth, Adam J.; Barch, Deanna M.

2017-01-01

Negative symptoms are a core clinical feature of schizophrenia, but conceptual and methodological problems with current instruments can make their assessment challenging. One hypothesis is that current symptom assessments may be influenced by impairments in memory and may not be fully reflective of actual functioning outside of the laboratory. The present study sought to investigate the validity of assessing negative symptoms using ecological momentary assessment (EMA). Participants with schizophrenia (N=31) completed electronic questionnaires on smartphones four times a day for one week. Participants also completed Effort-Based Decision Making and Reinforcement Learning (RL) tasks to assess the relationship between EMA and laboratory measures, which tap into negative symptom relevant domains. Hierarchical linear modeling analyses revealed that clinician-rated and self-report measures of negative symptoms were significantly related to negative symptoms assessed via EMA. However, working memory moderated the relationship between EMA and retrospective measures of negative symptoms, such that there was a stronger relationship between EMA and retrospective negative symptom measures among individuals with better working memory. We also found that negative symptoms assessed via EMA were related to poor performance on the Effort task, while clinician-rated symptoms and self-reports were not. Further, we found that negative symptoms were related to poorer performance on learning reward contingencies. Our findings suggest that negative symptoms can be assessed through EMA and that working memory impairments frequently seen in schizophrenia may affect recall of symptoms. Moreover, these findings suggest the importance of examining the relationship between laboratory tasks and symptoms assessed during daily life. PMID:27893230

Determination of mandibular border and functional movement protocols using an electromagnetic articulograph (EMA).

PubMed

Fuentes, Ramon; Navarro, Pablo; Curiqueo, Aldo; Ottone, Nicolas E

2015-01-01

The electromagnetic articulograph (EMA) is a device that can collect movement data by positioning sensors at multiple points, measuring displacements of the structure in real time, as well as the acoustics and mechanics of speech using a microphone connected to the measurement system. The aim of this study is to describe protocols for the generation, measurement and visualization of mandibular border and functional movements in the three spatial planes (frontal, sagittal and horizontal) using the EMA. The EMA has transmitter coils that determine magnetic fields to collect information about movements from sensors located on different structures (tongue, palate, mouth, incisors, skin, etc.) and in every direction in an area of 300 mm. After measurement with the EMA, the information is transferred to a computer and read with the Visartico software to visualize the recording of the mandibular movements registered by the EMA. The sensors placed in the space between the three axes XYZ are observed, and then the plots created from the mandibular movements included in the corresponding protocol can be visualized, enabling interpretation of these data. Four protocols for the obtaining of images of the opening and closing mandibular movements were defined and developed, as well as border movements in the frontal, sagittal and horizontal planes, managing to accurately reproduce Posselt's diagram and Gothic arch on the latter two axes. Measurements with the EMA will allow more exact data to be collected in relation to the mandibular clinical physiology and morphology, which will permit more accurate diagnoses and application of more precise and adjusted treatments in the future.

Assessing adolescent asthma symptoms and adherence using mobile phones.

PubMed

Mulvaney, Shelagh A; Ho, Yun-Xian; Cala, Cather M; Chen, Qingxia; Nian, Hui; Patterson, Barron L; Johnson, Kevin B

2013-07-17

Self-report is the most common method of measuring medication adherence but is influenced by recall error and response bias, and it typically does not provide insight into the causes of poor adherence. Ecological momentary assessment (EMA) of health behaviors using mobile phones offers a promising alternative to assessing adherence and collecting related data that can be clinically useful for adherence problem solving. To determine the feasibility of using EMA via mobile phones to assess adolescent asthma medication adherence and identify contextual characteristics of adherence decision making. We utilized a descriptive and correlational study design to explore a mobile method of symptom and adherence assessment using an interactive voice response system. Adolescents aged 12-18 years with a diagnosis of asthma and prescribed inhalers were recruited from an academic medical center. A survey including barriers to mobile phone use, the Illness Management Survey, and the Pediatric Asthma Quality of Life Questionnaire were administered at baseline. Quantitative and qualitative assessment of asthma symptoms and adherence were conducted with daily calls to mobile phones for 1 month. The Asthma Control Test (ACT) was administered at 2 study time points: baseline and 1 month after baseline. The sample consisted of 53 adolescents who were primarily African American (34/53, 64%) and female (31/53, 58%) with incomes US$40K/year or lower (29/53, 55%). The majority of adolescents (37/53, 70%) reported that they carried their phones with them everywhere, but only 47% (25/53) were able to use their mobile phone at school. Adolescents responded to an average of 20.1 (SD 8.1) of the 30 daily calls received (67%). Response frequency declined during the last week of the month (b=-0.29, P<.001) and was related to EMA-reported levels of rescue inhaler adherence (r= 0.33, P=.035). Using EMA, adolescents reported an average of 0.63 (SD 1.2) asthma symptoms per day and used a rescue inhaler an average of 70% of the time (SD 35%) when they experienced symptoms. About half (26/49, 53%) of the instances of nonadherence took place in the presence of friends. The EMA-measured adherence to rescue inhaler use correlated appropriately with asthma control as measured by the ACT (r=-0.33, P=.034). Mobile phones provided a feasible method to assess asthma symptoms and adherence in adolescents. The EMA method was consistent with the ACT, a widely established measure of asthma control, and results provided valuable insights regarding the context of adherence decision making that could be used clinically for problem solving or as feedback to adolescents in a mobile or Web-based support system.

International Society for Quality of Life Research commentary on the draft European Medicines Agency reflection paper on the use of patient-reported outcome (PRO) measures in oncology studies.

PubMed

Kyte, Derek; Reeve, Bryce B; Efficace, Fabio; Haywood, Kirstie; Mercieca-Bebber, Rebecca; King, Madeleine T; Norquist, Josephine M; Lenderking, William R; Snyder, Claire; Ring, Lena; Velikova, Galina; Calvert, Melanie

2016-02-01

In 2014, the European Medicines Agency (EMA) released for comment a draft reflection paper on the use of patient-reported outcome (PRO) measures in oncology studies. A twelve-member International Society for Quality of Life Research (ISOQOL) taskforce was convened to coordinate the ISOQOL response. Twenty-one ISOQOL members provided detailed comments and suggestions on the paper: 81 % from academia and 19 % from industry. Taskforce members consolidated and further refined these comments and shared the recommendations with the wider ISOQOL membership. A final response was submitted to the EMA in November 2014. The impending publication of the EMA reflection paper presents a valuable opportunity for ISOQOL to comment on the current direction of EMA PRO guidance and strategy. The EMA paper, although focused on cancer, could serve as a model for using PROs in other conditions, as it provides a useful update surrounding some of the design issues common to all trial research including PRO endpoints. However, we believe there are a number of additional areas in need of greater consideration. The purpose of this commentary is therefore to highlight the strengths of this timely and potentially useful document, but also to outline areas that may warrant further discussion.

Regulatory incentives to ensure better medicines for older people: From ICH E7 to the EMA reflection paper on quality aspects.

PubMed

van Riet-Nales, Diana A; Hussain, Nasir; Sundberg, Katarina A E; Eggenschwyler, Doris; Ferris, Cristina; Robert, Jean-Louis; Cerreta, Francesca

2016-10-30

Ageing comes with an increased propensity in the alteration of human organ and body functions, which can e.g. result in multi-morbidity, frailty, polypharmacy, altered medication safety and/or efficacy, and problems with the practical use of medicines in a real world setting. Such problems may e.g. involve difficulties opening containers, swallowing large tablets, breaking tablets by hand, or correctly understanding the user instruction. This review aims to summarize the European regulatory activities towards better medicines for older people, with a main focus on formulation development and the overall drug product design. It addresses the ICH E7 guideline "Studies in support of special populations, geriatrics", the ICH Q8 guideline "Pharmaceutical development", the EMA good practice guide on "Risk minimisation and prevention of medication errors" and the forthcoming EMA CHMP QWP reflection paper on the "Quality aspects (pharmaceutical development) of medicines for older people". In addition, three key aspects to the practical use of medicines by older people are discussed in a wider context: multi-particulates including small tablets (also referred to as mini-tablets), ease of opening and storage conditions. Furthermore, attention is paid to work in progress e.g. incentives by the European national drug regulatory authorities, and patient centric drug product development. Copyright © 2016 The Authors. Published by Elsevier B.V. All rights reserved.

Physical and social contextual influences on children's leisure-time physical activity: an ecological momentary assessment study.

PubMed

Dunton, Genevieve F; Liao, Yue; Intille, Stephen; Wolch, Jennifer; Pentz, Mary Ann

2011-01-01

This study used real-time electronic surveys delivered through mobile phones, known as Ecological Momentary Assessment (EMA), to determine whether level and experience of leisure-time physical activity differ across children's physical and social contexts. Children (N = 121; ages 9 to 13 years; 52% male, 32% Hispanic/Latino) participated in 4 days (Fri.-Mon.) of EMA during nonschool time. Electronic surveys (20 total) assessed primary activity (eg, active play/sports/exercise), physical location (eg, home, outdoors), social context (eg, friends, alone), current mood (positive and negative affect), and enjoyment. Responses were time-matched to the number of steps and minutes of moderate-to-vigorous physical activity (MVPA; measured by accelerometer) in the 30 minutes before each survey. Mean steps and MVPA were greater outdoors than at home or at someone else's house (all P < .05). Steps were greater with multiple categories of company (eg, friends and family together) than with family members only or alone (all P < .05). Enjoyment was greater outdoors than at home or someone else's house (all P < .05). Negative affect was greater when alone and with family only than friends only (all P < .05). Results describing the value of outdoor and social settings could inform context-specific interventions in this age group.

How do we diagnose and treat epilepsy with myoclonic-atonic seizures (Doose syndrome)? Results of the Pediatric Epilepsy Research Consortium survey.

PubMed

Nickels, Katherine; Thibert, Ronald; Rau, Stephanie; Demarest, Scott; Wirrell, Elaine; Kossoff, Eric H; Joshi, Charuta; Nangia, Srishti; Shellhaas, Renee

2018-04-25

To obtain and assess opinions on EMAS diagnostic criteria, recommended investigations, and therapeutic options, from a large group of physicians who care for children with EMAS. The EMAS focus group of PERC created a survey to assess the opinions of pediatric neurologists who care for children with EMAS regarding diagnosis and treatment of this condition, which was sent to members of PERC, AES, and CNS. A Likert scale was used to assess the respondents' opinions on the importance of diagnostic and exclusion criteria (five point scale), investigations (four point scale), and treatment (six point scale) of EMAS. Inclusion/exclusion criteria were then classified as critical, strong, or modest. Investigations were classified as essential, recommended, or possible. Therapies were classified as first line, beneficial, indeterminate benefit, or contraindicated. Survey results from the 76 participants determined the following: EMAS inclusion criteria: history suggestive of MAS (critical), recorded or home video suggestive of MAS, generalized discharges on inter-ictal EEG, normal neuroimaging, normal development prior to seizure onset (strong). EMAS exclusionary criteria: epileptic spasms, abnormal neuroimaging, focal abnormal exam, seizure onset six years (strong). EEG and MRI (essential), amino acids, organic acids, fatty acid/acylcarnitine profile, microarray, genetic panel, lactate/pyruvate, CSF and serum glucose/lactate (strong). Valproic acid (first line), topiramate, zonisamide, levetiracetam, benzodiazepines, and dietary therapies (beneficial). To date, no similar surveys have been published, even though early syndrome identification and initiation of effective treatment have been associated with improved outcome in EMAS. Medications that exacerbate seizures in EMAS have also been identified. This survey identified critical and preferred diagnostic electro clinical features, investigations, and treatments for EMAS. It will guide future research and is a crucial first step in defining specific diagnostic criteria, recommended evaluation, and most effective therapies for EMAS. Copyright © 2018 Elsevier B.V. All rights reserved.

Flow cytometric osmotic fragility test and eosin-5'-maleimide dye-binding tests are better than conventional osmotic fragility tests for the diagnosis of hereditary spherocytosis.

PubMed

Arora, R D; Dass, J; Maydeo, S; Arya, V; Radhakrishnan, N; Sachdeva, A; Kotwal, J; Bhargava, M

2018-06-01

Hereditary spherocytosis (HS) is the most common inherited hemolytic anemia with heterogeneous clinico-laboratory manifestations. We evaluated the flow-cytometric tests: eosin-5'-maleimide (EMA) and flow-cytometric osmotic fragility test (FOFT) and the conventional osmotic fragility tests (OFT) for the diagnosis of hereditary spherocytosis (HS). One hundred two suspected HS patients underwent EMA, FOFT, incubated OFT (IOFT), and room temperature OFT (RT-OFT). In addition, 10 cases of immune hemolytic anemia (IHA) were included, and performance of the above 4 tests was evaluated. For EMA and FOFT, 5 normal controls were assessed together with the patients and cutoffs were calculated using receiver-operator-characteristics curve (ROC) analysis. The best cutoff for %EMA decrease was 12.5%, and for FOFT, %residual red cells (%RRC) was 25.6%. The sensitivity and specificity of RT-OFT was 62.06% and 86.3%, respectively, while that of IOFT was 79.31% and 87.67%, respectively. Both flow cytometric tests performed better. Sensitivity and specificity of EMA was 86.2% and 93.9% respectively, and that of FOFT was 96.6% and 98.63%, respectively. The combination of the FOFT with IOFT or EMA dye-binding test yields a sensitivity of 100%, but with EMA, it had a higher specificity. Hb/MCHC was a predictor of the severity of the disease while %EMA decrease and %RRC did not correlate with severity of the disease. Flow-cytometric osmotic fragility test is the best possible single test followed by EMA for diagnosis of HS. A combination of FOFT and EMA can correctly diagnose 100% patients. These tests are likely to replace conventional OFTs in future. © 2018 John Wiley & Sons Ltd.

Examining Convergence of Retrospective and Ecological Momentary Assessment Measures of Negative Affect and Eating Disorder Behaviors

PubMed Central

Wonderlich, Joseph A.; Lavender, Jason M.; Wonderlich, Stephen A.; Peterson, Carol B.; Crow, Scott J.; Engel, Scott G.; Le Grange, Daniel; Mitchell, James E.; Crosby, Ross D.

2017-01-01

Objective Data gathered via retrospective forms of assessment are subject to various recall biases. Ecological momentary assessment (EMA) is an alternative approach involving repeated momentary assessments within a participant's natural environment, thus reducing recall biases and improving ecological validity. EMA has been used in numerous prior studies examining various constructs of theoretical relevance to eating disorders. Method This investigation includes data from three previously published studies with distinct clinical samples: (a) women with anorexia nervosa (N=118), (b) women with bulimia nervosa (N=133), and (c) obese men and women (N=50; 9 with current binge eating disorder). Each study assessed negative affective states and eating disorder behaviors using traditional retrospective assessments and EMA. Spearman rho correlations were used to evaluate the concordance of retrospective versus EMA measures of affective and/or behavioral constructs in each sample. Bland-Altman plots were also used to further evaluate concordance in the assessment of eating disorder behaviors. Results There was moderate to strong concordance for the measures of negative affective states across all three studies. Moderate to strong concordance was also found for the measures of binge eating and exercise frequency. The strongest evidence of concordance across measurement approaches was found for purging behaviors. Discussion Overall, these preliminary findings support the convergence of retrospective and EMA assessments of both negative affective states and various eating disorder behaviors. Given the advantages and disadvantages associated with each of these assessment approaches, the specific questions being studied in future empirical studies should inform decisions regarding selection of the most appropriate method. PMID:25195932

Post-authorisation passive enhanced safety surveillance of seasonal influenza vaccines: protocol of a pilot study in England.

PubMed

de Lusignan, Simon; Dos Santos, Gaël; Correa, Ana; Haguinet, François; Yonova, Ivelina; Lair, Florence; Byford, Rachel; Ferreira, Filipa; Stuttard, Karen; Chan, Tom

2017-05-17

To pilot enhanced safety surveillance of seasonal influenza vaccine meeting the European Medicines Agency (EMA) requirement to rapidly detect a significant increase in the frequency or severity of adverse events of interest (AEIs), which may indicate risk from the new season's vaccine. A prospective passive enhanced safety surveillance combining data collection from adverse drug reaction (ADR) cards with automated collection of pseudonymised routinely collected electronic health record (EHR) data. This study builds on a feasibility study carried out at the start of the 2015/2016 influenza season. We will report influenza vaccine exposure and any AEIs reported via ADR card or recorded directly into the EHR, from the commencement of influenza vaccination and ends as specified by EMA (30 November 2016). Ten volunteer English general practices, primarily using the GSK influenza vaccines. They had selected this vaccine in advance of the study. People who receive a seasonal influenza vaccine, in each age group defined in EMA interim guidance: 6 months to 5 years, 6-12 years, 13-17 years, 18-65 years and >65 years. The primary outcome measure is the rate of AEIs occurring within 7 days postvaccination, using passive surveillance of general practitioner (GP) EHR systems enhanced by a card-based ADR reporting system. Extracted data will be presented overall by brand (Fluarix Tetra vs others), by age strata and risk groups. The secondary outcome measure is the vaccine uptake among the subjects registered in the enrolled general practices. Ethical approval was granted by the Proportionate Review Sub-committee of the North East-Newcastle & North Tyneside 2 on 5 August 2016. The study received approval from the Health Research Authority on 1 September 2016. We will produce an interim analysis within 8 weeks, and an end-of-study report, which will be submitted to peer-reviewed journals. © 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.

Comparisons of two moments‐based estimators that utilize historical and paleoflood data for the log Pearson type III distribution

USGS Publications Warehouse

England, John F.; Salas, José D.; Jarrett, Robert D.

2003-01-01

The expected moments algorithm (EMA) [Cohn et al., 1997] and the Bulletin 17B [Interagency Committee on Water Data, 1982] historical weighting procedure (B17H) for the log Pearson type III distribution are compared by Monte Carlo computer simulation for cases in which historical and/or paleoflood data are available. The relative performance of the estimators was explored for three cases: fixed‐threshold exceedances, a fixed number of large floods, and floods generated from a different parent distribution. EMA can effectively incorporate four types of historical and paleoflood data: floods where the discharge is explicitly known, unknown discharges below a single threshold, floods with unknown discharge that exceed some level, and floods with discharges described in a range. The B17H estimator can utilize only the first two types of historical information. Including historical/paleoflood data in the simulation experiments significantly improved the quantile estimates in terms of mean square error and bias relative to using gage data alone. EMA performed significantly better than B17H in nearly all cases considered. B17H performed as well as EMA for estimating X100 in some limited fixed‐threshold exceedance cases. EMA performed comparatively much better in other fixed‐threshold situations, for the single large flood case, and in cases when estimating extreme floods equal to or greater than X500. B17H did not fully utilize historical information when the historical period exceeded 200 years. Robustness studies using GEV‐simulated data confirmed that EMA performed better than B17H. Overall, EMA is preferred to B17H when historical and paleoflood data are available for flood frequency analysis.

Comparisons of two moments-based estimators that utilize historical and paleoflood data for the log Pearson type III distribution

NASA Astrophysics Data System (ADS)

England, John F.; Salas, José D.; Jarrett, Robert D.

2003-09-01

The expected moments algorithm (EMA) [, 1997] and the Bulletin 17B [, 1982] historical weighting procedure (B17H) for the log Pearson type III distribution are compared by Monte Carlo computer simulation for cases in which historical and/or paleoflood data are available. The relative performance of the estimators was explored for three cases: fixed-threshold exceedances, a fixed number of large floods, and floods generated from a different parent distribution. EMA can effectively incorporate four types of historical and paleoflood data: floods where the discharge is explicitly known, unknown discharges below a single threshold, floods with unknown discharge that exceed some level, and floods with discharges described in a range. The B17H estimator can utilize only the first two types of historical information. Including historical/paleoflood data in the simulation experiments significantly improved the quantile estimates in terms of mean square error and bias relative to using gage data alone. EMA performed significantly better than B17H in nearly all cases considered. B17H performed as well as EMA for estimating X100 in some limited fixed-threshold exceedance cases. EMA performed comparatively much better in other fixed-threshold situations, for the single large flood case, and in cases when estimating extreme floods equal to or greater than X500. B17H did not fully utilize historical information when the historical period exceeded 200 years. Robustness studies using GEV-simulated data confirmed that EMA performed better than B17H. Overall, EMA is preferred to B17H when historical and paleoflood data are available for flood frequency analysis.

White spots in pharmaceutical pipelines-EMA identifies potential areas of unmet medical needs.

PubMed

Papaluca, Marisa; Greco, Martina; Tognana, Enrico; Ehmann, Falk; Saint-Raymond, Agnès

2015-05-01

Unmet medical needs are a priority for organizations such as the WHO and major public-private initiatives, such as Innovative Medicines Initiative, were established to speed up the development of better and safer medicines for patients. To assist such projects, the EMA in its 'Road Map to 2015' considered the mapping of unmet medical needs as a priority. This study has identified medical conditions for which the EMA could not identify developments in the pharmaceutical pipelines, that is, 'white spots'. Our analysis was made using external data sources as well as mining data of the EMA. The main areas for white spots were oncology, infectious diseases and certain psychiatric conditions. According to our data and a review of literature, in a number of these white spots, diagnostic tools may even be missing. The identification of those conditions will benefit stakeholders, including regulators, research funding bodies and patients' organizations.

Ecological Momentary Assessment of Adolescent Problems, Coping Efficacy, and Mood States Using a Mobile Phone App: An Exploratory Study

PubMed Central

Dooley, Barbara; Fitzgerald, Amanda

2016-01-01

Background Mobile technologies have the potential to be used as innovative tools for conducting research on the mental health and well-being of young people. In particular, they have utility for carrying out ecological momentary assessment (EMA) research by capturing data from participants in real time as they go about their daily lives. Objective The aim of this study was to explore the utility of a mobile phone app as a means of collecting EMA data pertaining to mood, problems, and coping efficacy in a school-based sample of Irish young people. Methods The study included a total of 208 participants who were aged 15-18 years, 64% female (113/208), recruited from second-level schools in Ireland, and who downloaded the CopeSmart mobile phone app as part of a randomized controlled trial. On the app, participants initially responded to 5 single-item measures of key protective factors in youth mental health (formal help-seeking, informal help-seeking, sleep, exercise, and sense of belonging). They were then encouraged to use the app daily to input data relating to mood states (happiness, sadness, anger, stress, and worry), daily problems, and coping self-efficacy. The app automatically collected data pertaining to user engagement over the course of the 28-day intervention period. Students also completed pen and paper questionnaires containing standardized measures of emotional distress (Depression, Anxiety, and Stress Scale; DASS-21), well-being (World Health Organization Well-Being Index; WHO-5), and coping (Coping Strategies Inventory; CSI). Results On average the participants completed 18% (5/28) of daily ratings, and engagement levels did not differ across gender, age, school, socioeconomic status, ethnicity, or nationality. On a scale of 1 to 10, happiness was consistently the highest rated mood state (overall mean 6.56), and anger was consistently the lowest (overall mean 2.11). Pearson correlations revealed that average daily ratings of emotional states were associated with standardized measures of emotional distress (rhappiness=–.45, rsadness=.51, ranger=.32, rstress=.41, rworry=.48) and well-being (rhappiness=.39, rsadness =–.43, ranger=–.27, rstress=–.35, rworry=–.33). Inferential statistics indicated that single-item indicators of key protective factors were related to emotional distress, well-being, and average daily mood states, as measured by EMA ratings. Hierarchical regressions revealed that greater daily problems were associated with more negative daily mood ratings (all at the P<.001 level); however, when coping efficacy was taken into account, the relationship between problems and happiness, sadness, and anger became negligible. Conclusions While engagement with the app was low, overall the EMA data collected in this exploratory study appeared valid and provided useful insights into the relationships between daily problems, coping efficacy, and mood states. Future research should explore ways to increase engagement with EMA mobile phone apps in adolescent populations to maximize the amount of data captured by these tools. Trial Registration Clinicaltrials.gov NCT02265978; http://clinicaltrials.gov/ct2/show/NCT02265978 (Archived by WebCite at http://www.webcitation.org/6mMeYqseA). PMID:27899340

Ecological Momentary Assessment of Mood Disorders and Mood Dysregulation

ERIC Educational Resources Information Center

Ebner-Priemer, Ulrich W.; Trull, Timothy J.

2009-01-01

In this review, we discuss ecological momentary assessment (EMA) studies on mood disorders and mood dysregulation, illustrating 6 major benefits of the EMA approach to clinical assessment: (a) Real-time assessments increase accuracy and minimize retrospective bias; (b) repeated assessments can reveal dynamic processes; (c) multimodal assessments…

Comparing daily drivers of problem drinking among older and younger adults: An electronic daily diary study using smartphones.

PubMed

Kuerbis, Alexis; Treloar Padovano, Hayley; Shao, Sijing; Houser, Jessica; Muench, Frederick J; Morgenstern, Jon

2018-02-01

By 2030, numbers and proportions of older adults with substance-use problems are expected to increase. While risk factors for problem drinking in late life have been identified, it remains unknown whether these factors drive daily drinking among older problem drinkers. This study examined the daily drivers of drinking among problem drinkers, moderated by age, utilizing ecological momentary assessment (EMA). Participants (N = 139), ages 20-73, received daily EMA online surveys completed via a smartphone prior to initiation of treatment. Multilevel modeling tested the moderating impact of age on within- and between-person relationships between drinking and focal predictors (mood, loneliness, boredom, stress, poor sleep, social factors, alcohol salience, commitment and confidence not to drink heavily). Older adults reported greater alcohol consumption when daily boredom levels were higher. Heavier drinking among younger adults was associated with poorer sleep quality. Greater daily confidence, daily commitment and daily alcohol salience did not impact drinking to the same extent for older adults as for younger adults. Greater person-level commitment predicted reduced drinking equivalently across age, but low person-level commitment predicted greater drinking among older adults compared to their younger counterparts. Older adults may have unique daily drivers of drinking that are not fully realized in current research and intervention efforts. Addressing the growing substance-use treatment needs among this population will require identifying the unique drivers of drinking among older adults, such as boredom, when compared to younger adults. Copyright © 2018 Elsevier B.V. All rights reserved.

Detection of Legionella species in environmental water by the quantitative PCR method in combination with ethidium monoazide treatment.

PubMed

Inoue, Hiroaki; Takama, Tomoko; Yoshizaki, Miwa; Agata, Kunio

2015-01-01

We detected Legionella species in 111 bath water samples and 95 cooling tower water samples by using a combination of conventional plate culture, quantitative polymerase chain reaction (qPCR) and qPCR combined with ethidium monoazide treatment (EMA-qPCR) methods. In the case of bath water samples, Legionella spp. were detected in 30 samples by plate culture, in 85 samples by qPCR, and in 49 samples by EMA-qPCR. Of 81 samples determined to be Legionella-negative by plate culture, 56 and 23 samples were positive by qPCR and EMA-qPCR, respectively. Therefore, EMA treatment decreased the number of Legionella-positive bath water samples detected by qPCR. In contrast, EMA treatment had no effect on cooling tower water samples. We therefore expect that EMA-qPCR is a useful method for the rapid detection of viable Legionella spp. from bath water samples.

Biocatalytic Conversion of Avermectin to 4"-Oxo-Avermectin: Characterization of Biocatalytically Active Bacterial Strains and of Cytochrome P450 Monooxygenase Enzymes and Their Genes

PubMed Central

Jungmann, Volker; Molnár, István; Hammer, Philip E.; Hill, D. Steven; Zirkle, Ross; Buckel, Thomas G.; Buckel, Dagmar; Ligon, James M.; Pachlatko, J. Paul

2005-01-01

4"-Oxo-avermectin is a key intermediate in the manufacture of the agriculturally important insecticide emamectin benzoate from the natural product avermectin. Seventeen biocatalytically active Streptomyces strains with the ability to oxidize avermectin to 4"-oxo-avermectin in a regioselective manner have been discovered in a screen of 3,334 microorganisms. The enzymes responsible for this oxidation reaction in these biocatalytically active strains were found to be cytochrome P450 monooxygenases (CYPs) and were termed Ema1 to Ema17. The genes for Ema1 to Ema17 have been cloned, sequenced, and compared to reveal a new subfamily of CYPs. Ema1 to Ema16 have been overexpressed in Escherichia coli and purified as His-tagged recombinant proteins, and their basic enzyme kinetic parameters have been determined. PMID:16269732

Influences of Electromagnetic Articulography Sensors on Speech Produced by Healthy Adults and Individuals with Aphasia and Apraxia

ERIC Educational Resources Information Center

Katz, William F.; Bharadwaj, Sneha V.; Stettler, Monica P.

2006-01-01

Purpose: This study examined whether the intraoral transducers used in electromagnetic articulography (EMA) interfere with speech and whether there is an added risk of interference when EMA systems are used to study individuals with aphasia and apraxia. Method: Ten adult talkers (5 individuals with aphasia/apraxia, 5 controls) produced 12 American…

Simultaneous determination of emamectin and ivermectin residues in Atlantic salmon muscle by liquid chromatography with fluorescence detection.

PubMed

van de Riet, J M; Brothers, N N; Pearce, J N; Burns, B G

2001-01-01

A liquid chromatographic (LC) method for determining residues of the antiparasitic drugs emamectin (EMA) and ivermectin (IVR) in fish tissues has been developed. EMA and IVR residues are extracted with acetonitrile and cleaned up on a C18 solid-phase extraction column. Extracts are derivatized with 1-methylimidazole and trifluoroacetic anhydride and the components are determined by LC on a C18 reversed-phase column with fluorescence detection (excitation: 365 nm, emission: 470 nm). The mobile phase is 94% acetonitrile-water run isocratically. Calibration curves were linear between 1 and 32 ng injected for both EMA and IVR. The limit of detection for both analytes was 0.5 ng/g, with a limit of quantitation of 1.5 ng/g. Recoveries of EMA and IVR added to salmon muscle averaged 96 +/- 9% and 86 +/- 6%, respectively, at levels between 5 and 80 ng/g. The percent relative standard deviation for the described method was less than 7% over the range of concentrations studied. The operational errors, interferences, and recoveries for fortified samples compare favorably with an established IVR method. The recommended method is simple, rapid, and specific for monitoring residues of EMA and IVR in Atlantic salmon muscle.

Young adult non-smokers' exposure to real-world tobacco marketing: results of an ecological momentary assessment pilot study.

PubMed

Rose, Shyanika W; Anesetti-Rothermel, Andrew; Elmasry, Hoda; Niaura, Ray

2017-08-31

The aims of this pilot study were to assess and characterize non-current smoking young adults' exposure to tobacco marketing through an ecological momentary assessment protocol. Ecological momentary assessment (EMA) consists of repeated measurement of momentary phenomena and is well-suited to capture sporadic experiences in the real-world, such as exposure to tobacco marketing. EMA has the potential to capture detailed information about real-world marketing exposures in ways that reduce recall bias and increase ecological validity. In this study, young adults (n = 31; ages 18-25) responded to random prompts regarding their momentary exposure to tobacco marketing via text messages on their smartphones for 14 days (n = 1798 observations). Unadjusted and adjusted analyses were conducted using multilevel logistic regression to assess the odds of exposure accounting for correlation of multiple repeated measures within individuals while controlling for variability between individuals. Respondents reported, on average, two momentary exposures to tobacco advertising in the 14-day study period. In adjusted analyses, African-American (aOR 3.36; 95% CI 1.07, 10.54) and Hispanic respondents (aOR 5.08; 95% CI 1.28, 20.13) were more likely to report exposure to tobacco advertising. Respondents were also more likely to report exposure when also exposed to others using tobacco products and when they were at stores compared with at home (aOR 14.82; 95% CI 3.61, 60.88). Non-smoking young adults report exposure to tobacco marketing particularly at the point-of-sale, with the highest likelihood of exposure among African-American and Hispanic young people. EMA protocols can be effective in assessing the potential impact of point-of-sale tobacco marketing on young adults.

Smartphone-based ecological momentary assessment for Chinese patients with depression: An exploratory study in Taiwan.

PubMed

Hung, Shan; Li, Min-Shan; Chen, Yen-Lin; Chiang, Jung-Hsien; Chen, Ying-Yeh; Hung, Galen Chin-Lun

2016-10-01

Mobile mental health has a potential to improve the recognition and management of Chinese patients with depression. Currently, evidence regarding ecological momentary assessment (EMA) for depressive disorder mostly originates from Western studies. Herein, we examined the validity of smartphone-based EMA for depression in Chinese patients and explored the determinants of use. A smartphone application, iHOPE, was used to perform daily EMA of depression, anxiety, sleep and cognitive performance. Outpatients with depressive disorder were recruited to use iHOPE for 8 weeks. Clinical characteristics and smartphone use patterns were assessed at baseline. We enrolled 59 Chinese patients with depression. In 8 weeks, participants interacted with iHOPE for an average of 10.8 (SD=12.3) days; a trend of decreased frequency of use (p=0.03) was observed. Scores of HAM-D at baseline was associated with, of the first 2 weeks, scores of PHQ-9 (p=0.005), EMA of depression (p=0.003) and anxiety (p<0.001), and poorer sleep quality (p=0.023). Among the demographic, clinical and smartphone-use variables examined, only limited internet package for smartphone (<500M per month) predicted higher use of iHOPE (p=0.04). The present study provides initial evidence for the feasibility of smartphone-based EMA in Chinese patients with depression. Level of engagement needs to be improved before determining its clinical usefulness. Copyright © 2016 Elsevier B.V. All rights reserved.

Utilization of an introduced weed biological control agent by a native parasitoid

USDA-ARS?s Scientific Manuscript database

A native parasitoid, Kalopolynema ema (Schauff and Grissell) (Hymenoptera, Mymaridae), that usually parasitizes the eggs of Megamelus davisi VanDuzee (Hemiptera, Delphacidae), has begun utilizing a new host, Megamelus scutellaris (Berg) (Hemiptera, Delphacidae), the introduced biological control age...

Association of Environmental Indicators with Teen Alcohol Use and Problem Behavior: Teens’ Observations vs. Objectively-Measured Indicators

PubMed Central

Byrnes, Hilary F.; Miller, Brenda A.; Morrison, Christopher N.; Wiebe, Douglas J.; Woychik, Marcie; Wiehe, Sarah E.

2017-01-01

Most prior studies use objectively measured data (e.g., census-based indicators) to assess contextual risks. However, teens’ observations might be more important for their risk behavior. Objectives: 1) determine relationships between observed and objective indicators of contextual risks 2) determine relations of observed and objective indicators with teen alcohol use and problem behavior. Teens aged 14–16 (N=170) carried GPS-enabled smartphones for one month, with locations documented. Ecological momentary assessment (EMA) measured teens’ observations via texts regarding risk behaviors and environmental observations. Objective indicators of alcohol outlets and disorganization were spatially joined to EMAs based on teens’ location at the time of the texts. Observed and objective disorganization, and objective indicators of alcohol outlets were related to alcohol use. Observed disorganization was related to problem behavior, while objective indicators were unrelated. Findings suggest the importance of considering teens’ observations of contextual risk for understanding influences on risk behavior and suggest future directions for research and prevention strategies. PMID:28061392

Data-based comparisons of moments estimators using historical and paleoflood data

USGS Publications Warehouse

England, J.F.; Jarrett, R.D.; Salas, J.D.

2003-01-01

This paper presents the first systematic comparison, using historical and paleoflood data, of moments-based flood frequency methods. Peak flow estimates were compiled from streamflow-gaging stations with historical and/or paleoflood data at 36 sites located in the United States, Argentina, United Kingdom and China, covering a diverse range of hydrologic conditions. The Expected Moments Algorithm (EMA) and the Bulletin 17B historical weighting procedure (B17H) were compared in terms of goodness of fit using 25 of the data sets. Results from this comparison indicate that EMA is a viable alternative to current B17H procedures from an operational perspective, and performed equal to or better than B17H for the data analyzed. We demonstrate satisfactory EMA performance for the remaining 11 sites with multiple thresholds and binomial censoring, which B17H cannot accommodate. It is shown that the EMA estimator readily incorporates these types of information and the LP-III distribution provided an adequate fit to the data in most cases. The results shown here are consistent with Monte Carlo simulation studies, and demonstrate that EMA is preferred overall to B17H. The Bulletin 17B document could be revised to include an option for EMA as an alternative to the existing historical weighting approach. These results are of practical relevance to hydrologists and water resources managers for applications in floodplain management, design of hydraulic structures, and risk analysis for dams. ?? 2003 Elsevier Science B.V. All rights reserved.

Data-based comparisons of moments estimators using historical and paleoflood data

NASA Astrophysics Data System (ADS)

England, John F.; Jarrett, Robert D.; Salas, José D.

2003-07-01

This paper presents the first systematic comparison, using historical and paleoflood data, of moments-based flood frequency methods. Peak flow estimates were compiled from streamflow-gaging stations with historical and/or paleoflood data at 36 sites located in the United States, Argentina, United Kingdom and China, covering a diverse range of hydrologic conditions. The Expected Moments Algorithm (EMA) and the Bulletin 17B historical weighting procedure (B17H) were compared in terms of goodness of fit using 25 of the data sets. Results from this comparison indicate that EMA is a viable alternative to current B17H procedures from an operational perspective, and performed equal to or better than B17H for the data analyzed. We demonstrate satisfactory EMA performance for the remaining 11 sites with multiple thresholds and binomial censoring, which B17H cannot accommodate. It is shown that the EMA estimator readily incorporates these types of information and the LP-III distribution provided an adequate fit to the data in most cases. The results shown here are consistent with Monte Carlo simulation studies, and demonstrate that EMA is preferred overall to B17H. The Bulletin 17B document could be revised to include an option for EMA as an alternative to the existing historical weighting approach. These results are of practical relevance to hydrologists and water resources managers for applications in floodplain management, design of hydraulic structures, and risk analysis for dams.

Can an app help identify psychomotor function impairments during drinking occasions in the real world? A mixed-method pilot study.

PubMed

Suffoletto, Brian; Goyal, Akash; Puyana, Juan Carlos; Chung, Tammy

2017-01-01

Being able to measure the acute effects of alcohol consumption on psychomotor functions in natural settings could be useful in injury prevention interventions. This study examined the feasibility and acceptability of collecting app-based measures of information processing, working memory, and gait stability during times of typical alcohol consumption among young adults. Ten young adults (aged 21-26) with hazardous drinking completed a baseline assessment and ecological momentary assessments (EMA) on 4 consecutive Fridays and Saturdays, every hour from 8 pm to 12 am. EMA assessed alcohol consumption and perceived intoxication, followed by a digit symbol substitution task (DSST), a visuospatial working memory task (VSWMT), and a 5-step tandem gait task (TGT). Exit interviews probed user experiences. Multilevel models explored relationships between estimated blood alcohol concentration (eBAC; mg/dL) and DSST and VSWMT performance. Participants completed 32% of EMA. Higher rates of noninitiation occurred later in the evening and over time. In multilevel models, higher eBAC was associated with lower DSST scores. Eight out of 10 individuals had at least 1 drinking occasion when they did not perceive any intoxication. Lower DSST scores would identify impairment in 45% of these occasions. Exit interviews indicated that adding real-time feedback on task performance could increase awareness of alcohol effects. Collecting app-based psychomotor performance data from young adults during drinking occasions is feasible and acceptable, but strategies to reduce barriers to task initiation are needed. Mobile DSST is sensitive to eBAC levels and could identify occasions when an individual may not perceive impairments.

Momentary affect predicts bodily movement in daily life: an ambulatory monitoring study.

PubMed

Schwerdtfeger, Andreas; Eberhardt, Ragna; Chmitorz, Andrea; Schaller, Eva

2010-10-01

There is converging evidence that physical activity influences affective states. It has been found that aerobic exercise programs can significantly diminish negative affect. Moreover, among healthy individuals, moderate levels of physical activity seem to increase energetic arousal and positive affect. However, the predictive utility of affective states for bodily movement has rarely been investigated. In this study, we examined whether momentarily assessed affect is associated with bodily movement in everyday life. Using a previously published data set (Schwerdtfeger, Eberhardt, & Chmitorz, 2008), we reanalyzed 12-hr ecological momentary assessment (EMA) data from 124 healthy volunteers. Electronic momentary positive-activated affect (EMA-PAA) and negative affect (EMA-NA) were assessed via handheld computers, and bodily movement was recorded via accelerosensors. Generalized linear mixed models were calculated. Results indicated that EMAPAA increases were accompanied by bodily movement increases of varying intensity. EMA-NA was also positively associated with increases in certain kinds of bodily movement. In light of previous research, this finding suggests that affect and bodily movement may have circular effects on each other.

Violence exposure and adolescents' same-day obesogenic behaviors: New findings and a replication.

PubMed

Piontak, Joy Rayanne; Russell, Michael A; Danese, Andrea; Copeland, William E; Hoyle, Rick H; Odgers, Candice L

2017-09-01

To test whether exposure to violence is associated with same-day increases in obesogenic behaviors among young adolescents, including unhealthy food and beverage consumption, poor quality sleep, and lack of physical activity. Young at-risk adolescents between 12 and 15 years of age were recruited via telephone screening from low-income neighborhoods. Adolescents and their parents completed in-person assessments, followed by Ecological Momentary Assessment (EMA) delivered to 151 adolescents' mobile phones three times a day for 30 days (4329 person days). Three obesogenic behaviors - unhealthy food consumption, poor sleep quality, and lack of physical activity - and violence exposure were assessed daily. Adolescents' body mass index (BMI) was assessed prior to the EMA and 18 months later. A replication was performed among 395 adolescents from a population-representative sample (with 5276 EMA person days). On days that at-risk adolescents were exposed versus not exposed to violence, they were more likely to consume unhealthy foods and beverages (b = 0.12, p = 0.01), report feeling tired the next morning (OR = 1.58, p < 0.01), and to be active (OR = 1.61, p < 0.01). At-risk adolescents who reported higher consumption of soda and caffeinated beverages during the 30-day EMA were more likely to experience increases in BMI in later adolescence. Findings related to sleep and activity were supported in the population-based replication sample; however, no significant same-day associations were found between violence exposure and unhealthy dietary consumption. This study provides evidence that exposure to violence is associated with same-day unhealthy dietary consumption among at-risk adolescents and next-day tiredness related to sleep quality among adolescents from both at-risk and normative populations. Findings also point to unhealthy soda consumption during early adolescence as an important predictor of weight gain among at-risk adolescents. Copyright © 2017. Published by Elsevier Ltd.

Violence exposure and adolescents’ same-day obesogenic behaviors: New findings and a replication

PubMed Central

Piontak, Joy Rayanne; Russell, Michael A.; Danese, Andrea; Copeland, William E.; Hoyle, Rick H.; Odgers, Candice L.

2018-01-01

Objective To test whether exposure to violence is associated with same-day increases in obesogenic behaviors among young adolescents, including unhealthy food and beverage consumption, poor quality sleep, and lack of physical activity. Methods Young at-risk adolescents between 12 and 15 years of age were recruited via telephone screening from low-income neighborhoods. Adolescents and their parents completed in-person assessments, followed by Ecological Momentary Assessment (EMA) delivered to 151 adolescents’ mobile phones three times a day for 30 days (4329 person days). Three obesogenic behaviors – unhealthy food consumption, poor sleep quality, and lack of physical activity – and violence exposure were assessed daily. Adolescents’ body mass index (BMI) was assessed prior to the EMA and 18 months later. A replication was performed among 395 adolescents from a population-representative sample (with 5276 EMA person days). Results On days that at-risk adolescents were exposed versus not exposed to violence, they were more likely to consume unhealthy foods and beverages (b = 0.12, p = 0.01), report feeling tired the next morning (OR = 1.58, p < 0.01), and to be active (OR = 1.61, p < 0.01). At-risk adolescents who reported higher consumption of soda and caffeinated beverages during the 30-day EMA were more likely to experience increases in BMI in later adolescence. Findings related to sleep and activity were supported in the population-based replication sample; however, no significant same-day associations were found between violence exposure and unhealthy dietary consumption. Conclusions This study provides evidence that exposure to violence is associated with same-day unhealthy dietary consumption among at-risk adolescents and next-day tiredness related to sleep quality among adolescents from both at-risk and normative populations. Findings also point to unhealthy soda consumption during early adolescence as an important predictor of weight gain among at-risk adolescents. PMID:28768573

Application of EMA-qPCR as a complementary tool for the detection and monitoring of Legionella in different water systems.

PubMed

Qin, Tian; Tian, Zhengan; Ren, Hongyu; Hu, Guangchun; Zhou, Haijian; Lu, Jinxing; Luo, Chengwang; Liu, Zunyu; Shao, Zhujun

2012-05-01

Legionella are prevalent in human-made water systems and cause legionellosis in humans. Conventional culturing and polymerase chain reaction (PCR) techniques are not sufficiently accurate for the quantitative analysis of live Legionella bacteria in water samples because of the presence of viable but nonculturable cells and dead cells. Here, we report a rapid detection method for viable Legionella that combines ethidium monoazide (EMA) with quantitative real-time PCR (qPCR) and apply this method to detect Legionella in a large number of water samples from different sources. Results yielded that samples treated with 5 μg/ml EMA for 10 min and subsequently exposed to light irradiation for 5 min were optimal for detecting Legionella. EMA treatment before qPCR could block the signal from approximately 4 log(10) of dead cells. When investigating environmental water samples, the percent-positive rate obtained by EMA-qPCR was significantly higher than conventional PCR and culture methods, and slightly lower than qPCR. The bacterial count of Legionella determined by EMA-qPCR were mostly greater than those determined by culture assays and lower than those determined by qPCR. Acceptable correlations were found between the EMA-qPCR and qPCR results for cooling towers, piped water and hot spring water samples (r = 0.849, P < 0.001) and also found between the EMA-qPCR and culture results for hot spring water samples (r = 0.698, P < 0.001). The results indicate that EMA-qPCR could be used as a complementary tool for the detection and monitoring of Legionella in water systems, especially in hot spring water samples.

Predicting Sexual Behaviors Among Homeless Young Adults: Ecological Momentary Assessment Study

PubMed Central

Padhye, Nikhil; Yang, Yijiong; Gallardo, Kathryn; Businelle, Michael

2018-01-01

Background Homeless youth continue to be disproportionately affected by HIV compared with their housed peers, with prevalence rates as high as 13%. Yet, HIV prevention in this high-risk population has been only marginally effective. Objective The aim of this study was to use ecological momentary assessments to examine real-time factors to determine the predictors of sexual activity among homeless youth. Methods Youth experiencing homelessness aged between 18 and 24 years were recruited from a drop-in center in Houston, Texas, between August 2015 and May 2016. All the participants received a study-issued mobile phone that prompted brief ecological momentary assessments (EMAs) 5 times a day for 21 days. EMA items assessed near real-time sexual behaviors, cognitions, stress, affect, environmental factors, and environmental circumstances. Results Participants (N=66) were predominantly male (41/66, 64%) and black (43/66, 66%) with a median age of 20 years. The mean number of EMAs completed by each participant was 45 out of 105 possible observations. During the study, 70% (46/66) of participants were sexually active and reported condomless sex in 102 of the 137 cases of sexual intercourse (74.5%). In total, 82% (38/46) of the youth who reported having sex during the 3 weeks of data collection also reported engaging in high-risk sexual activities, including having condomless sex (24/46, 53%), having multiple sexual partners on the same day (12/46, 26%), trading sex (7/46, 16%), and sharing needles while injecting drugs (1/46, 3%). Of those, 71% (27/38) were engaged in multiple sexual risk behaviors. The predictive model was based on observations from 66 subjects who reported 137 cases of sexual intercourse over 811 days; sexual orientation, race, mental health, drug use, and sexual urge were included as predictors in the parsimonious generalized linear mixed model selected on the basis of the Akaike information criterion. The estimated odds ratios (ORs) were notable for same-day drug use (OR 8.80, 95% CI 4.48-17.31; P<.001) and sexual urge (OR 4.23, 95% CI 1.60-11.28; P=.004). The performance of the risk estimator was satisfactory, as indicated by the value of 0.834 for the area under the receiver operating characteristic curve. Conclusions Real-time EMA data can be used to predict sexual intercourse among a sample of high-risk, predominately unsheltered homeless youth. Sexual urge and drug use accounts for increased odds of engaging in sexual activity on any given day. Interventions targeting sexual urge and drug use may help predict sexual activity among a population at high risk of HIV. PMID:29636318

Momentary factors during marijuana use as predictors of lapse during attempted abstinence in young adults.

PubMed

Shrier, Lydia A; Sarda, Vishnudas; Jonestrask, Cassandra; Harris, Sion Kim

2018-08-01

Young adults using marijuana heavily often try multiple times to quit on their own. We sought to identify momentary experiences during marijuana use that could aid in predicting lapse when young adults subsequently attempt abstinence. Young adults (N=34) age 18-25 using marijuana ≥5days/week and planning to quit completed a survey of sociodemographic characteristics, substance use, marijuana expectancies, use motives, perceived social support, and confidence to abstain. They completed ecological momentary assessment (EMA) smartphone reports several times/day for two weeks prior to, then during two weeks of attempted abstinence. Use period EMA reports assessed affect, craving, accessibility, situational permissibility, use, and motivation to abstain. Baseline survey and EMA data were examined in relation to subsequent lapse during attempted abstinence. Nearly 3 in 4 participants (73.5%) reported lapsing during attempted abstinence from marijuana. On bivariate analyses, lower baseline dependence severity score, negative effect expectancies, perceived family support, and confidence to abstain were each associated with lapse. Of the use period EMA variables, greater percent of days with marijuana use, reports of easy accessibility, and reports of situational permissibility were each associated with lapse. Modeled together, negative effect expectancies, perceived family support, confidence to abstain, and situational permissibility during use were highly accurate in predicting lapse during attempted abstinence. Momentary factors may add to conventionally-surveyed characteristics to enhance prediction of lapse during attempted abstinence among young adults with heavy marijuana use. Momentary assessment prior to a quit attempt may thus enable more effective personalized approaches to preventing lapse. Copyright © 2018 Elsevier Ltd. All rights reserved.

Development and validation of a novel questionnaire for self-determination of the range of motion of wrist and elbow.

PubMed

Schnetzke, Marc; Schüler, Svenja; Keil, Holger; Aytac, Sara; Studier-Fischer, Stefan; Grützner, Paul-Alfred; Guehring, Thorsten

2016-07-26

The aim of this study was to develop and validate a novel self-administered questionnaire for assessing the patient's own range of motion (ROM) of the wrist and the elbow. In a prospective clinical study from January 2015 to June 2015, 101 consecutive patients were evaluated with a novel, self-administered, diagram-based, wrist motion assessment score (W-MAS) and elbow motion assessment score (E-MAS). The questionnaire was statistically evaluated for test-retest reliability, patient-physician agreement, comparison with healthy population, and influence of covariates (age, gender, affected side and involvement in workers' compensation cases). Assessment of patient-physician agreement demonstrated almost perfect agreement (k > 0.80) with regard to six out of eight items. There was substantial agreement with regard to two items: elbow extension (k = 0.76) and pronation (k = 0.75). The assessment of the test-retest reliability revealed at least substantial agreement (k = 0.70). The questionnaire revealed a high discriminative power when comparing the healthy population with the study group (p = 0.007 or lower for every item). Age, gender, affected side and involvement in workers' compensation cases did not in general significantly influence the patient-physician agreement for the questionnaire. The W-MAS and E-MAS are valid and reliable self-administered questionnaires that provide a high level of patient-physician agreement for the assessments of wrist and elbow ROM. Diagnostic study, Level II.

Daily Associations of Stress and Eating in Mother-Child Dyads

ERIC Educational Resources Information Center

Dunton, Genevieve F.; Dzubur, Eldin; Huh, Jimi; Belcher, Britni R.; Maher, Jaclyn P.; O'Connor, Sydney; Margolin, Gayla

2017-01-01

Background and Aims. This study used Ecological Momentary Assessment (EMA) in mother-child dyads to examine the day-level associations of stress and eating. Method. Mothers and their 8- to 12-year-old children (N = 167 dyads) completed between three (weekday) and eight (weekend) EMA survey prompts per day at random nonschool times across 8 days.…

In vivo oxalate degradation by liposome encapsulated oxalate oxidase in rat model of hyperoxaluria

PubMed Central

Dahiya, Tulika; Pundir, C.S.

2013-01-01

Background & objectives: High level of urinary oxalate substantially increases the risk of hyperoxaluria, a significant risk factor for urolithiasis. The primary goal of this study was to reduce urinary oxalate excretion employing liposome encapsulated oxalate oxidase in animal model. Methods: A membrane bound oxalate oxidase was purified from Bougainvillea leaves. The enzyme in its native form was less effective at the physiological pH of the recipient animal. To increase its functional viability, the enzyme was immobilized on to ethylene maleic anhydride (EMA). Rats were injected with liposome encapsulated EMA- oxalate oxidase and the effect was observed on degradation of oxalic acid. Results: The enzyme was purified to apparent homogeneity with 60-fold purification and 31 per cent yield. The optimum pH of EMA-derivative enzyme was 6.0 and it showed 70 per cent of its optimal activity at pH 7.0. The EMA-bound enzyme encapsulated into liposome showed greater oxalate degradation in 15 per cent casein vitamin B6 deficient fed rats as compared with 30 per cent casein vitamin B6 deficient fed rats and control rats. Interpretation & conclusions: EMA-oxalate oxidase encapsulated liposome caused oxalate degradation in experimental hyperoxaluria indicating that the enzyme could be used as a therapeutic agent in hyperoxaluria leading to urinary stones. PMID:23481063

Experimental self-etching HEMA-free adhesive systems: cytotoxicity and degree of conversion.

PubMed

Barbosa, Marília Oliveira; de Carvalho, Rodrigo Varella; Demarco, Flávio Fernando; Ogliari, Fabrício Aulo; Zanchi, Cesar Henrique; Piva, Evandro; da Silva, Adriana Fernandes

2015-01-01

The aim of this study was to evaluate the effect of replacing 2-hydroxyethyl methacrylate (HEMA) by methacrylate surfactant monomers on the cytotoxicity and degree of conversion of two-step self-etching dentin adhesive systems. Five HEMA-free adhesive systems were tested: Bis-EMA 10, Bis-EMA 30, PEG400, PEG400UDMA, PEG1000, and a HEMA group was used as positive control. The cytotoxicity of the experimental primers, with different monomer concentrations (2 or 20 wt%), and bond resins, containing 25 wt% surfactant, was assessed using murine fibroblast cell line 3T3 and the tetrazolium assay (3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT)). The degree of conversion of the bond resins was analyzed using Fourier transform infrared spectroscopy. The data were submitted to statistical analysis using level of significance set at P < 0.05. The PEG 1000 group obtained higher cell viability in comparison with HEMA in the 2 % primer. The cell survival rate using 20 % primer showed that PEG1000 and BIS-EMA 10 were less cytotoxic than HEMA. With regard to the eluate from bond resin, the data showed that the groups BIS-EMA 10, BIS-EMA 30 and PEG400UDMA were less cytotoxic than HEMA. No statistically significant difference was found among degrees of conversion of the experimental groups and HEMA. PEG 1000, BIS-EMA 10 and 30 monomers showed the biological potential for use in new adhesive system formulations since they showed lower cytotoxicity and similar degree of conversion when compared with the HEMA-containing group.

Supertoughened renewable PLA reactive multiphase blends system: phase morphology and performance.

PubMed

Zhang, Kunyu; Nagarajan, Vidhya; Misra, Manjusri; Mohanty, Amar K

2014-08-13

Multiphase blends of poly(lactic acid) (PLA), ethylene-methyl acrylate-glycidyl methacrylate (EMA-GMA) terpolymer, and a series of renewable poly(ether-b-amide) elastomeric copolymer (PEBA) were fabricated through reactive melt blending in an effort to improve the toughness of the PLA. Supertoughened PLA blend showing impact strength of ∼500 J/m with partial break impact behavior was achieved at an optimized blending ratio of 70 wt % PLA, 20 wt % EMA-GMA, and 10 wt % PEBA. Miscibility and thermal behavior of the binary blends PLA/PEBA and PLA/EMA-GMA, and the multiphase blends were also investigated through differential scanning calorimetric (DSC) and dynamic mechanical analysis (DMA). Phase morphology and fracture surface morphology of the blends were studied through scanning electron microscopy (SEM) and atomic force microscopy (AFM) to understand the strong corelation between the morphology and its significant effect on imparting tremendous improvement in toughness. A unique "multiple stacked structure" with partial encapsulation of EMA-GMA and PEBA minor phases was observed for the PLA/EMA-GMA/PEBA (70/20/10) revealing the importance of particular blend composition in enhancing the toughness. Toughening mechanism behind the supertoughened PLA blends have been established by studying the impact fractured surface morphology at different zones of fracture. Synergistic effect of good interfacial adhesion and interfacial cavitations followed by massive shear yielding of the matrix was believed to contribute to the enormous toughening effect observed in these multiphase blends.

Numerical simulation of dynamics of brushless dc motors for aerospace and other applications. Volume 1: Model development and applications, part A

NASA Technical Reports Server (NTRS)

Demerdash, N. A. O.; Nehl, T. W.

1979-01-01

The development, fabrication and evaluation of a prototype electromechanical actuator (EMA) is discussed. Application of the EMA as a motor for control surfaces in aerospace flight is examined. A mathematical model of the EMA is developed for design optimization. Nonlinearities which complicate the mathematical model are discussed. The dynamics of the EMA from the underlying physical principles are determined and a discussion of similating the control logic by means of equivalent boolean expressions is presented.

Detection of Celiac Disease and Lymphocytic Enteropathy by Parallel Serology and Histopathology in a Population-Based Study

PubMed Central

Walker, Marjorie M.; Murray, Joseph A.; Ronkainen, Jukka; Aro, Pertti; Storskrubb, Tom; D’Amato, Mauro; Lahr, Brian; Talley, Nicholas J.; Agreus, Lars

2010-01-01

Background & Aims Although serological analysis is used in diagnosis of celiac disease, histopathology is considered most reliable. We performed a prospective study to determine the clinical, pathological and serological spectrum of celiac disease in a general population (Kalixanda study). Methods A random sample of an adult general population (n=1000) was analyzed by upper endoscopy, duodenal biopsy, and serological analysis of tissue transglutaminase (tTg) levels; endomysial antibody (EMA) levels were analyzed in samples that were tTg+. The cutoff values for diagnosis of celiac disease were villous atrophy with 40 intraepithelial lymphocytes (IELs)/100 enterocytes (ECs). Results Samples from 33 subjects were tTg+ and 16 were EMA+. Histological analysis identified 7/1000 subjects (0.7%) with celiac disease; all were tTg+ and 6/7 were EMA+. Another 26 subjects were tTg+ (7/26 EMA+). This was addressed by a second quantitative pathology study, (nested case-control design) using a threshold of 25 IELS/100 ECs. In this analysis, all 13 samples that were tTg+ and EMA+ had ≥25 IELs/100ECs. In total, 16 subjects (1.6%) had serological and histological evidence of gluten-sensitive enteropathy. IELs were quantified in duodenal biopsy samples from seronegative individuals (n=500); 19 (3.8%) had >25 IELs and lymphocytic duodenosis (LD). Conclusions Measurement of ≥25 IELs/100 ECs correlated with serological indicators of celiac disease; a higher IEL threshold could miss 50% of cases. Quantification of tTg is a sensitive test for celiac disease; diagnosis can be confirmed by observation of ≥25 IELs/100ECs in duodenal biopsies. Lymphocytic enteropathy (celiac disease and LD) is common in the population (5.4%). PMID:20398668

Pediatric investigation plans for specific immunotherapy: Questionable contributions to childhood health.

PubMed

Rose, Klaus; Kopp, Matthias Volkmar

2015-12-01

Allergen-specific immunotherapy (SIT) is the only disease-modifying treatment for children, adolescents, and adults with allergic diseases. The EU has a combined system of national and EU-wide marketing authorization for all medicines. Germany introduced a new therapy allergen ordinance in 2008. Allergen products manufacturers had to apply for marketing authorization application for the major allergen groups (grass group, birch group, mites group, bee/wasp venom). Due to the EU pediatric regulation, in force since 2007, manufacturers had also to submit a pediatric investigation plan (PIP) for each allergen product. We investigated the allergic rhinoconjunctivitis (ARC) standard PIP, developed jointly by the European Medicines Agency (EMA) and the German Paul Ehrlich Institut (PEI). We analyzed the 118 EMA PIP decisions, looked for SIT trials in children in www.clinicaltrials.gov, and further analyzed EMA/EU justifications. The PIPs request a 1-year dose-finding study in adults, a 5-year placebo-controlled (PC) efficacy & safety (E&S) study in adults, and a 5-year PC E&S study in children. Fifty-eight PIP development programs will have to be performed until 2031. But children benefit even more from SIT for ARC than adults. There is no convincing medical/scientific justification for PC E&S studies in children in the relevant EMA documents. The PIP requirement to withhold effective treatment to thousands of children in the placebo group over a 5-year period raises profound concerns. The EMA justifications are formalistic and lack scientific foundation. A critical academic review of the ARC PIPs and the entire PIP system is urgently needed. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Ecological Momentary Assessment of Adolescent Problems, Coping Efficacy, and Mood States Using a Mobile Phone App: An Exploratory Study.

PubMed

Kenny, Rachel; Dooley, Barbara; Fitzgerald, Amanda

2016-11-29

Mobile technologies have the potential to be used as innovative tools for conducting research on the mental health and well-being of young people. In particular, they have utility for carrying out ecological momentary assessment (EMA) research by capturing data from participants in real time as they go about their daily lives. The aim of this study was to explore the utility of a mobile phone app as a means of collecting EMA data pertaining to mood, problems, and coping efficacy in a school-based sample of Irish young people. The study included a total of 208 participants who were aged 15-18 years, 64% female (113/208), recruited from second-level schools in Ireland, and who downloaded the CopeSmart mobile phone app as part of a randomized controlled trial. On the app, participants initially responded to 5 single-item measures of key protective factors in youth mental health (formal help-seeking, informal help-seeking, sleep, exercise, and sense of belonging). They were then encouraged to use the app daily to input data relating to mood states (happiness, sadness, anger, stress, and worry), daily problems, and coping self-efficacy. The app automatically collected data pertaining to user engagement over the course of the 28-day intervention period. Students also completed pen and paper questionnaires containing standardized measures of emotional distress (Depression, Anxiety, and Stress Scale; DASS-21), well-being (World Health Organization Well-Being Index; WHO-5), and coping (Coping Strategies Inventory; CSI). On average the participants completed 18% (5/28) of daily ratings, and engagement levels did not differ across gender, age, school, socioeconomic status, ethnicity, or nationality. On a scale of 1 to 10, happiness was consistently the highest rated mood state (overall mean 6.56), and anger was consistently the lowest (overall mean 2.11). Pearson correlations revealed that average daily ratings of emotional states were associated with standardized measures of emotional distress (r happiness =-.45, r sadness =.51, r anger =.32, r stress =.41, r worry =.48) and well-being (r happiness =.39, r sadness =-.43, r anger =-.27, r stress =-.35, r worry =-.33) . Inferential statistics indicated that single-item indicators of key protective factors were related to emotional distress, well-being, and average daily mood states, as measured by EMA ratings. Hierarchical regressions revealed that greater daily problems were associated with more negative daily mood ratings (all at the P<.001 level); however, when coping efficacy was taken into account, the relationship between problems and happiness, sadness, and anger became negligible. While engagement with the app was low, overall the EMA data collected in this exploratory study appeared valid and provided useful insights into the relationships between daily problems, coping efficacy, and mood states. Future research should explore ways to increase engagement with EMA mobile phone apps in adolescent populations to maximize the amount of data captured by these tools. Clinicaltrials.gov NCT02265978; http://clinicaltrials.gov/ct2/show/NCT02265978 (Archived by WebCite at http://www.webcitation.org/6mMeYqseA). ©Rachel Kenny, Barbara Dooley, Amanda Fitzgerald. Originally published in JMIR Mental Health (http://mental.jmir.org), 29.11.2016.

Does laboratory cue reactivity correlate with real-world craving and smoking responses to cues?

PubMed

Shiffman, Saul; Li, Xiaoxue; Dunbar, Michael S; Tindle, Hilary A; Scholl, Sarah M; Ferguson, Stuart G

2015-10-01

Laboratory cue reactivity (CR) assessments are used to assess smokers' responses to cues. Likewise, EMA recording is used to characterize real-world response to cues. Understanding the relationship between CR and EMA responses addresses the ecological validity of CR. In 190 daily smokers not currently quitting, craving and smoking responses to cues were assessed in laboratory CR and by real-world EMA recording. Separate CR sessions involved 5 smoking-relevant cues (smoking, alcohol, negative affect, positive affect, smoking prohibitions), and a neutral cue. Subjects used EMA to monitor smoking situations for 3 weeks, completing parallel situational assessments (presence of others smoking, alcohol consumption, negative affect, positive affect, and smoking prohibitions, plus current craving) in smoking and non-smoking occasions (averaging 70 and 60 occasions each). Analyses correlated CR craving and smoking cue responses with EMA craving and smoking correlations with similar cues. Although some cues did not show main effects on average craving or smoking, a wide range of individual differences in response to cues was apparent in both CR and EMA data, providing the necessary context to assess their relationship. Laboratory CR measures of cue response were not correlated with real-world cue responses assessed by EMA. The average correlation was 0.03; none exceeded 0.32. One of 40 correlations examined was significantly greater than 0. Laboratory CR measures do not correlate with EMA-assessed craving or smoking in response to cues, suggesting that CR measures are not accurate predictors of how smokers react to relevant stimuli in the real world. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Biocatalytic Conversion of Avermectin to 4"-Oxo-Avermectin: Heterologous Expression of the ema1 Cytochrome P450 Monooxygenase

PubMed Central

Molnár, István; Hill, D. Steven; Zirkle, Ross; Hammer, Philip E.; Gross, Frank; Buckel, Thomas G.; Jungmann, Volker; Pachlatko, Johannes Paul; Ligon, James M.

2005-01-01

The cytochrome P450 monooxygenase Ema1 from Streptomyces tubercidicus R-922 and its homologs from closely related Streptomyces strains are able to catalyze the regioselective oxidation of avermectin into 4"-oxo-avermectin, a key intermediate in the manufacture of the agriculturally important insecticide emamectin benzoate (V. Jungmann, I. Molnár, P. E. Hammer, D. S. Hill, R. Zirkle, T. G. Buckel, D. Buckel, J. M. Ligon, and J. P. Pachlatko, Appl. Environ. Microbiol. 71:6968-6976, 2005). The gene for Ema1 has been expressed in Streptomyces lividans, Streptomyces avermitilis, and solvent-tolerant Pseudomonas putida strains using different promoters and vectors to provide biocatalytically competent cells. Replacing the extremely rare TTA codon with the more frequent CTG codon to encode Leu4 in Ema1 increased the biocatalytic activities of S. lividans strains producing this enzyme. Ferredoxins and ferredoxin reductases were also cloned from Streptomyces coelicolor and biocatalytic Streptomyces strains and tested in ema1 coexpression systems to optimize the electron transport towards Ema1. PMID:16269733

Linear Extended State Observer-Based Motion Synchronization Control for Hybrid Actuation System of More Electric Aircraft.

PubMed

Wang, Xingjian; Liao, Rui; Shi, Cun; Wang, Shaoping

2017-10-25

Moving towards the more electric aircraft (MEA), a hybrid actuator configuration provides an opportunity to introduce electromechanical actuator (EMA) into primary flight control. In the hybrid actuation system (HAS), an electro-hydraulic servo actuator (EHSA) and an EMA operate on the same control surface. In order to solve force fighting problem in HAS, this paper proposes a novel linear extended state observer (LESO)-based motion synchronization control method. To cope with the problem of unavailability of the state signals required by the motion synchronization controller, LESO is designed for EHSA and EMA to observe the state variables. Based on the observed states of LESO, motion synchronization controllers could enable EHSA and EMA to simultaneously track the desired motion trajectories. Additionally, nonlinearities, uncertainties and unknown disturbances as well as the coupling term between EHSA and EMA can be estimated and compensated by using the extended state of the proposed LESO. Finally, comparative simulation results indicate that the proposed LESO-based motion synchronization controller could reduce significant force fighting between EHSA and EMA.

Rubber elasticity for percolation network consisting of Gaussian chains.

PubMed

Nishi, Kengo; Noguchi, Hiroshi; Sakai, Takamasa; Shibayama, Mitsuhiro

2015-11-14

A theory describing the elastic modulus for percolation networks of Gaussian chains on general lattices such as square and cubic lattices is proposed and its validity is examined with simulation and mechanical experiments on well-defined polymer networks. The theory was developed by generalizing the effective medium approximation (EMA) for Hookian spring network to Gaussian chain networks. From EMA theory, we found that the ratio of the elastic modulus at p, G to that at p = 1, G0, must be equal to G/G0 = (p - 2/f)/(1 - 2/f) if the position of sites can be determined so as to meet the force balance, where p is the degree of cross-linking reaction. However, the EMA prediction cannot be applicable near its percolation threshold because EMA is a mean field theory. Thus, we combine real-space renormalization and EMA and propose a theory called real-space renormalized EMA, i.e., REMA. The elastic modulus predicted by REMA is in excellent agreement with the results of simulations and experiments of near-ideal diamond lattice gels.

Linear Extended State Observer-Based Motion Synchronization Control for Hybrid Actuation System of More Electric Aircraft

PubMed Central

Liao, Rui; Shi, Cun; Wang, Shaoping

2017-01-01

Moving towards the more electric aircraft (MEA), a hybrid actuator configuration provides an opportunity to introduce electromechanical actuator (EMA) into primary flight control. In the hybrid actuation system (HAS), an electro-hydraulic servo actuator (EHSA) and an EMA operate on the same control surface. In order to solve force fighting problem in HAS, this paper proposes a novel linear extended state observer (LESO)-based motion synchronization control method. To cope with the problem of unavailability of the state signals required by the motion synchronization controller, LESO is designed for EHSA and EMA to observe the state variables. Based on the observed states of LESO, motion synchronization controllers could enable EHSA and EMA to simultaneously track the desired motion trajectories. Additionally, nonlinearities, uncertainties and unknown disturbances as well as the coupling term between EHSA and EMA can be estimated and compensated by using the extended state of the proposed LESO. Finally, comparative simulation results indicate that the proposed LESO-based motion synchronization controller could reduce significant force fighting between EHSA and EMA. PMID:29068392

Rubber elasticity for percolation network consisting of Gaussian chains

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

Nishi, Kengo, E-mail: kengo.nishi@phys.uni-goettingen.de, E-mail: sakai@tetrapod.t.u-tokyo.ac.jp, E-mail: sibayama@issp.u-tokyo.ac.jp; Noguchi, Hiroshi; Shibayama, Mitsuhiro, E-mail: kengo.nishi@phys.uni-goettingen.de, E-mail: sakai@tetrapod.t.u-tokyo.ac.jp, E-mail: sibayama@issp.u-tokyo.ac.jp

2015-11-14

A theory describing the elastic modulus for percolation networks of Gaussian chains on general lattices such as square and cubic lattices is proposed and its validity is examined with simulation and mechanical experiments on well-defined polymer networks. The theory was developed by generalizing the effective medium approximation (EMA) for Hookian spring network to Gaussian chain networks. From EMA theory, we found that the ratio of the elastic modulus at p, G to that at p = 1, G{sub 0}, must be equal to G/G{sub 0} = (p − 2/f)/(1 − 2/f) if the position of sites can be determined somore » as to meet the force balance, where p is the degree of cross-linking reaction. However, the EMA prediction cannot be applicable near its percolation threshold because EMA is a mean field theory. Thus, we combine real-space renormalization and EMA and propose a theory called real-space renormalized EMA, i.e., REMA. The elastic modulus predicted by REMA is in excellent agreement with the results of simulations and experiments of near-ideal diamond lattice gels.« less

Scaled Inverse Probability Weighting: A Method to Assess Potential Bias Due to Event Nonreporting in Ecological Momentary Assessment Studies

ERIC Educational Resources Information Center

Kovalchik, Stephanie A.; Martino, Steven C.; Collins, Rebecca L.; Shadel, William G.; D'Amico, Elizabeth J.; Becker, Kirsten

2018-01-01

Ecological momentary assessment (EMA) is a popular assessment method in psychology that aims to capture events, emotions, and cognitions in real time, usually repeatedly throughout the day. Because EMA typically involves more intensive monitoring than traditional assessment methods, missing data are commonly an issue and this missingness may bias…

Acceptability of Ecological Momentary Assessment among Young Men Who Have Sex with Men

ERIC Educational Resources Information Center

Duncan, Dustin T.; Kapadia, Farzana; Kirchner, Thomas R.; Goedel, William C.; Brady, William J.; Halkitis, Perry N.

2017-01-01

The study evaluated the acceptability of text message- and voice-based ecological momentary assessment (EMA) methods among a sample (N = 74) of young men who have sex with men (MSM). We assessed the acceptability of text message- and voice-based EMA methods. Almost all participants (96%) reported that they would be willing to accept texts on their…

Ecological Momentary Assessment and Smartphone Application Intervention in Adolescents with Substance Use and Comorbid Severe Psychiatric Disorders: Study Protocol.

PubMed

Benarous, Xavier; Edel, Yves; Consoli, Angèle; Brunelle, Julie; Etter, Jean-François; Cohen, David; Khazaal, Yasser

2016-01-01

Substance use disorders (SUDs) are highly prevalent among inpatient adolescents with psychiatric disorders. In this population, substance use and other psychiatric outcomes can reinforce one another. Despite the need for integrated interventions in youths with dual diagnoses, few specific instruments are available. App-based technologies have shown promising results to help reduce substance use in adolescents, but their applicability in youths with associated severe psychiatric disorders is poorly documented. We aim to evaluate the feasibility of an ecological momentary assessment (EMA) intervention for all substance users, and of a smartphone application for cannabis users (Stop-Cannabis), for outpatient treatment after hospital discharge. All inpatient adolescents with psychiatric disorders hospitalized between 2016 and 2018 in a university hospital will be systematically screened for SUD and, if positive, will be assessed by an independent specialist addiction team. Participants with confirmed SUDs will be invited and helped to download an EMA app and, if required, the Stop-Cannabis app, the week preceding hospital discharge. Information about the acceptability and use of both apps and the validity of EMA data in comparison to clinical assessments will be assessed after 6 months and 1 year. This research has been designed to raise specific issues for consideration regarding the sequence between substance use, contextual factors, and other psychiatric symptoms among adolescents with comorbid severe psychiatric disorders. A better understanding of the mechanisms involved will inform the development of integrated treatment for dual disorders at that age. The study has already been approved and granted. Dissemination will include presentations at international congresses as well as publications in peer-reviewed journals. European Clinical Trials Database: Number 2016-001999-30.

Pathological Gambling, Problem Gambling and Sleep Complaints: An Analysis of the National Comorbidity Survey: Replication (NCS-R)

PubMed Central

Siani, Aaron; Rosenthal, Richard J.; Fong, Timothy W.

2012-01-01

The purpose of this study is to investigate the relationship between sleep disturbances and gambling behavior. Data from the National Comorbidity Survey—Replication (NCS-R) was used to examine the relationship between three specific sleep complaints (difficulty initiating sleep [DIS], difficulty maintaining sleep [DMS], and early morning awakening [EMA]) and gambling behavior. Bivariate logistic regression models were used to control for potentially confounding psychiatric disorders and age. Almost half of respondents with problem gambling behavior (45.9%) and two thirds (67.7%) of respondents with pathological gambling behavior reported at least one sleep compliant. Compared to respondents with no gambling pathology, respondents with pathological gambling were significantly more likely to report at least one sleep complaint (Adjusted Odds Ratio [AOR] = 3.444, 95% CI = 1.538–7.713), to report all sleep complaints (AOR = 3.449, 95% CI = 1.503–7.914), and to report any individual complaint (DIS: OR = 2.300, 95% CI = 1.069–4.946; DMS: AOR = 4.604, 95% CI = 2.093–10.129; EMA: AOR = 3.968, 95% CI = 1.856–8.481). The relationship between problem gambling and sleep complaints were more modest (any sleep complaint: AOR = 1.794, 95% CI = 1.142–2.818; all three sleep complaints: AOR = 2.144, 95% CI = 1.169–3.931; DIS: AOR = 1.961, 95% CI = 1.204–3.194; DMS: AOR = 1.551, 95% CI = 0.951–2.529; EMA: AOR = 1.796, 95% CI = 1.099–2.935). Given the individual and societal ramifications linked with the presence of sleep problems, this study presents another health-related repercussion associated with gambling pathology rarely discussed in the literature. PMID:22396174

Expression of nestin, mesothelin and epithelial membrane antigen (EMA) in developing and adult human meninges and meningiomas.

PubMed

Petricevic, Josko; Forempoher, Gea; Ostojic, Ljerka; Mardesic-Brakus, Snjezana; Andjelinovic, Simun; Vukojevic, Katarina; Saraga-Babic, Mirna

2011-11-01

The spatial and temporal pattern of appearance of nestin, epithelial membrane antigen (EMA) and mesothelin proteins was immunohistochemically determined in the cells of normal developing and adult human meninges and meningiomas. Human meninges developed as two mesenchymal condensations in the head region. The simple squamous epithelium on the surface of leptomeninges developed during mesenchymal to epithelial transformation. Nestin appeared for the first time in week 7, EMA in week 8, while mesothelin appeared in week 22 of development. In the late fetal period and after birth, nestin expression decreased, whereas expression of EMA and mesothelin increased. EMA appeared in all surface epithelial cells and nodules, while mesothelin was found only in some of them. In adult meninges, all three proteins were predominantly localized in the surface epithelium and meningeal nodules. In meningothelial meningiomas (WHO grade I), EMA was detected in all tumor cells except in the endothelial cells, mesothelin characterized nests of tumor cells, while nestin was found predominantly in the walls of blood vessels. The distribution pattern of those proteins in normal meningeal and tumor cells indicates that nestin might characterize immature cells, while EMA and mesothelin appeared in maturing epithelial cells. Neoplastic transformation of these specific cell lineages contributes to the cell population in meningiomas. Copyright © 2010 Elsevier GmbH. All rights reserved.

Colonic involvement in celiac disease and possible implications of the sigmoid mucosa organ culture in its diagnosis.

PubMed

Picarelli, Antonio; Di Tola, Marco; Borghini, Raffaele; Isonne, Claudia; Saponara, Annarita; Marino, Mariacatia; Casale, Rossella; Tiberti, Antonio; Pica, Roberta; Donato, Giuseppe; Frieri, Giuseppe; Corazziari, Enrico

2013-10-01

Celiac disease (CD), a systemic autoimmune disorder that typically involves duodenal mucosa, can also affect other intestinal areas. Duodenal and oral mucosa organ culture has already been demonstrated as a reliable procedure to identify CD. The present study investigated gluten-dependent immunological activation of colonic mucosa in CD patients. We took advantage of the numerous colonoscopies performed for various clinical conditions or only for defensive medicine. Forty-four patients with gastrointestinal symptoms or in need of colorectal cancer screening were divided into patients with serum anti-endomysium (EMA) and anti-tissue transglutaminase (anti-tTG) antibody positive results (Group A), patients with serum antibody negative results (Group B), and patients with inflammatory bowel disease (IBD) (Group C). The autoantibodies EMA and anti-tTG were evaluated in supernatants of cultured sigmoid and duodenal biopsies from patients on a gluten-containing diet. In Group A, EMA and anti-tTG resulted positive in all duodenal culture supernatants. In sigmoid culture supernatants, EMA and anti-tTG were detected in 12/16 (75 %) and 13/16 (81.3 %) patients, respectively. In Group B, none of the 17 patients showed EMA and anti-tTG positive results in both duodenal and sigmoid cultures. In Group C, all 11 patients presented EMA negative results in sigmoid cultures. Only in one patient, anti-tTG were detectable in the sigmoid culture supernatant, as expected in cases of IBD. Data confirm that the gluten-dependent immunological activation affects more intestinal tracts with different degrees of involvement, suggesting that the organ culture of colonic biopsies could represent a new tool to opportunistically detect CD.

Estimating the Reliability of Aggregated and Within-Person Centered Scores in Ecological Momentary Assessment

ERIC Educational Resources Information Center

Huang, Po-Hsien; Weng, Li-Jen

2012-01-01

A procedure for estimating the reliability of test scores in the context of ecological momentary assessment (EMA) was proposed to take into account the characteristics of EMA measures. Two commonly used test scores in EMA were considered: the aggregated score (AGGS) and the within-person centered score (WPCS). Conceptually, AGGS and WPCS represent…

Use of pupil size to determine the effect of electromagnetic acupuncture on activation level of the autonomic nervous system.

PubMed

Kim, Soo-Byeong; Choi, Woo-Hyuk; Liu, Wen-Xue; Lee, Na-Ra; Shin, Tae-Min; Lee, Yong-Heum

2014-06-01

Magnetic fields are widely considered as a method of treatment to increase the therapeutic effect when applied to acupoints. Hence, this study proposes a new method which creates significant stimulation of acupoints by using weak magnetic fields. We conducted this experiment in order to confirm the effect on the activation level of the autonomic nervous system by measuring pupil sizes in cases of stimulation by using manual acupuncture and electromagnetic acupuncture (EMA) at BL15. We selected 30 Hz of biphasic wave form with 570.1 Gauss. To confirm the biopotential by the magnetic flux density occurring in EMA that affected the activation of the autonomic nervous system, we observed the biopotential induced at the upper and the mid left and right trapezius. We observed a significant decrease in pupil size only in the EMA group (p < 0.05), thus confirming that EMA decreased the pupil size through activation of the parasympathetic nerve in the autonomic nervous system. Moreover, we confirmed that the amplitude of the biopotential which was caused by 570.1 Gauss was higher than ±20 μA. Thus, we can conclude that EMA treatment successfully activates the parasympathetic nerve in the autonomic nervous system by inducing a biotransformation by the induced biopotential. Copyright © 2014. Published by Elsevier B.V.

The Origin and Evolutionary Consequences of Skeletal Traits Shaped by Embryonic Muscular Activity, from Basal Theropods to Modern Birds.

PubMed

Vargas, Alexander O; Ruiz-Flores, Macarena; Soto-Acuña, Sergio; Haidr, Nadia; Acosta-Hospitaleche, Carolina; Ossa-Fuentes, Luis; Muñoz-Walther, Vicente

2017-12-01

Embryonic muscular activity (EMA) is involved in the development of several distinctive traits of birds. Modern avian diversity and the fossil record of the dinosaur-bird transition allow special insight into their evolution. Traits shaped by EMA result from mechanical forces acting at post-morphogenetic stages, such that genes often play a very indirect role. Their origin seldom suggests direct selection for the trait, but a side-effect of other changes such as musculo-skeletal rearrangements, heterochrony in skeletal maturation, or increased incubation temperature (which increases EMA). EMA-shaped traits like sesamoids may be inconstant, highly conserved, or even disappear and then reappear in evolution. Some sesamoids may become increasingly influenced in evolution by genetic-molecular mechanisms (genetic assimilation). There is also ample evidence of evolutionary transitions from sesamoids to bony eminences at tendon insertion sites, and vice-versa. This can be explained by newfound similarities in the earliest development of both kinds of structures, which suggest these transitions are likely triggered by EMA. Other traits that require EMA for their formation will not necessarily undergo genetic assimilation, but still be conserved over tens and hundreds of millions of years, allowing evolutionary reduction and loss of other skeletal elements. Upon their origin, EMA-shaped traits may not be directly genetic, nor immediately adaptive. Nevertheless, EMA can play a key role in evolutionary innovation, and have consequences for the subsequent direction of evolutionary change. Its role may be more important and ubiquitous than currently suspected. © The Author 2017. Published by Oxford University Press on behalf of the Society for Integrative and Comparative Biology. All rights reserved. For permissions please email: journals.permissions@oup.com.

An EMA analysis of the effect of increasing word length on consonant production in apraxia of speech: a case study.

PubMed

Bartle, Carly J; Goozée, Justine V; Murdoch, Bruce E

2007-03-01

The effect of increasing word length on the articulatory dynamics (i.e. duration, distance, maximum acceleration, maximum deceleration, and maximum velocity) of consonant production in acquired apraxia of speech was investigated using electromagnetic articulography (EMA). Tongue-tip and tongue-back movement of one apraxic patient was recorded using the AG-200 EMA system during word-initial consonant productions in one, two, and three syllable words. Significantly deviant articulatory parameters were recorded for each of the target consonants during one, two, and three syllables words. Word length effects were most evident during the release phase of target consonant productions. The results are discussed with respect to theories of speech motor control as they relate to AOS.

Does access to clinical study reports from the European Medicines Agency reduce reporting biases? A systematic review and meta-analysis of randomized controlled trials on the effect of erythropoiesis-stimulating agents in cancer patients

PubMed Central

Grabik, Michael; Tonia, Thomy; Jüni, Peter; Pétavy, Frank; Pignatti, Francesco

2017-01-01

Since 2010, the European Medicines Agency (EMA) has provided access to clinical study reports (CSRs). We requested CSRs for randomized controlled trials (RCTs) of erythropoiesis-stimulating agents (ESAs) in cancer patients from EMA and identified RCT publications with literature searches. We assessed CSR availability and completeness, the impact of unreported and unpublished data obtained from CSRs on the effects of ESAs on quality of life (QoL) of cancer patients, and discrepancies between data reported in the public domain and in CSRs. We used random-effects meta-analyses to evaluate the effect of ESAs on QoL measured with Functional Assessment of Cancer Therapy-Anemia (FACT-An), FACT-Fatigue (FACT-F) and FACT-Anemia Total (FACT-An Total) stratified by data source and the impact of discrepancies on QoL, mortality, adverse events, and clinical effectiveness outcomes. We identified 94 eligible RCTs; CSRs or other study documentation were available for 17 (18%) RCTs at EMA. Median report length was 1,825 pages (range 72–14,569). Of 180 outcomes of interest reported in the EMA documentation, 127 (71%) were publicly available. For 80 of those (63%) we noted discrepancies, but these had little impact on the pooled effect estimates. Of 27 QoL outcomes reported in the CSRs, 17 (63%) were unpublished. Including six unpublished comparisons (pooled mean difference [MD] 0.20; 95% confidence interval [CI] -1.93, 2.33) reduced the pooled effect of ESAs for FACT-An from MD 5.51 (95% CI 4.20, 6.82) in published data to MD 3.21 (95% CI 1.38, 5.03), which is below a clinically important difference (defined as MD ≥4). Effects were similar for FACT-F and FACT-An Total. Access to CSRs from EMA reduced reporting biases for QoL outcomes. However, EMA received documentation for a fraction of all RCTs on effects of ESAs in cancer patients. Additional efforts by other agencies and institutions are needed to make CSRs universally available for all RCTs. PMID:29228059

Association of environmental indicators with teen alcohol use and problem behavior: Teens' observations vs. objectively-measured indicators.

PubMed

Byrnes, Hilary F; Miller, Brenda A; Morrison, Christopher N; Wiebe, Douglas J; Woychik, Marcie; Wiehe, Sarah E

2017-01-01

Most prior studies use objectively measured data (e.g., census-based indicators) to assess contextual risks. However, teens' observations might be more important for their risk behavior. 1) determine relationships between observed and objective indicators of contextual risks 2) determine relations of observed and objective indicators with teen alcohol use and problem behavior. Teens aged 14-16 (N=170) carried GPS-enabled smartphones for one month, with locations documented. Ecological momentary assessment (EMA) measured teens' observations via texts regarding risk behaviors and environmental observations. Objective indicators of alcohol outlets and disorganization were spatially joined to EMAs based on teens' location at the time of the texts. Observed and objective disorganization, and objective indicators of alcohol outlets were related to alcohol use. Observed disorganization was related to problem behavior, while objective indicators were unrelated. Findings suggest the importance of considering teens' observations of contextual risk for understanding influences on risk behavior and suggest future directions for research and prevention strategies. Copyright © 2016 Elsevier Ltd. All rights reserved.

Understanding the physical and social contexts of children's nonschool sedentary behavior: an ecological momentary assessment study.

PubMed

Liao, Yue; Intille, Stephen; Wolch, Jennifer; Pentz, Mary Ann; Dunton, Genevieve Fridlund

2014-03-01

Research on children's sedentary behavior has relied on recall-based self-report or accelerometer methods, which do not assess the context of such behavior. This study used ecological momentary assessment (EMA) to determine where and with whom children's sedentary behavior occurs during their nonschool time. Children (N = 120) ages 9-13 years (51% male, 33% Hispanic) wore mobile phones that prompted surveys (20 total) for 4 days. Surveys measured current activity (eg, exercise, watching TV), physical location (eg, home, outdoors), and social company (eg, family, friends). Children engaged in a greater percentage of leisure-oriented (eg, watching TV) than productive (eg, reading, doing homework) sedentary behavior (70% vs 30%, respectively). Most of children's sedentary activity occurred at home (85%). Children's sedentary activity took place most often with family members (58%). Differences in physical context of sedentary behavior were found for older vs. younger children (P < .05). Type of sedentary behavior differed by gender, racial/ethnic group, and social context (P < .05). Children may prefer or have greater opportunities to be sedentary in some contexts than others. Research demonstrates the potential for using EMA to capture real-time information about children's sedentary behavior during their nonschool time.

Efficient constraint handling in electromagnetism-like algorithm for traveling salesman problem with time windows.

PubMed

Yurtkuran, Alkın; Emel, Erdal

2014-01-01

The traveling salesman problem with time windows (TSPTW) is a variant of the traveling salesman problem in which each customer should be visited within a given time window. In this paper, we propose an electromagnetism-like algorithm (EMA) that uses a new constraint handling technique to minimize the travel cost in TSPTW problems. The EMA utilizes the attraction-repulsion mechanism between charged particles in a multidimensional space for global optimization. This paper investigates the problem-specific constraint handling capability of the EMA framework using a new variable bounding strategy, in which real-coded particle's boundary constraints associated with the corresponding time windows of customers, is introduced and combined with the penalty approach to eliminate infeasibilities regarding time window violations. The performance of the proposed algorithm and the effectiveness of the constraint handling technique have been studied extensively, comparing it to that of state-of-the-art metaheuristics using several sets of benchmark problems reported in the literature. The results of the numerical experiments show that the EMA generates feasible and near-optimal results within shorter computational times compared to the test algorithms.

Dynamic Stiffness Transfer Function of an Electromechanical Actuator Using System Identification

NASA Astrophysics Data System (ADS)

Kim, Sang Hwa; Tahk, Min-Jea

2018-04-01

In the aeroelastic analysis of flight vehicles with electromechanical actuators (EMAs), an accurate prediction of flutter requires dynamic stiffness characteristics of the EMA. The dynamic stiffness transfer function of the EMA with brushless direct current (BLDC) motor can be obtained by conducting complicated mathematical calculations of control algorithms and mechanical/electrical nonlinearities using linearization techniques. Thus, system identification approaches using experimental data, as an alternative, have considerable advantages. However, the test setup for system identification is expensive and complex, and experimental procedures for data collection are time-consuming tasks. To obtain the dynamic stiffness transfer function, this paper proposes a linear system identification method that uses information obtained from a reliable dynamic stiffness model with a control algorithm and nonlinearities. The results of this study show that the system identification procedure is compact, and the transfer function is able to describe the dynamic stiffness characteristics of the EMA. In addition, to verify the validity of the system identification method, the simulation results of the dynamic stiffness transfer function and the dynamic stiffness model were compared with the experimental data for various external loads.

A Comparative Review of Waivers Granted in Pediatric Drug Development by FDA and EMA from 2007-2013

PubMed Central

Egger, Gunter F.; Wharton, Gerold T.; Malli, Suzanne; Temeck, Jean; Murphy, M. Dianne; Tomasi, Paolo

2016-01-01

Background The European Union and the United States have different legal frameworks in place for pediatric drug development, which can potentially lead to different pediatric research requirements for the pharmaceutical industry. This manuscript compares pediatric clinical trial waivers granted by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). Methods This is a retrospective review comparing EMA’s Paediatric Committee (PDCO) decisions with FDA’s Pediatric Review Committee (PeRC) recommendations for all product-specific pediatric full waiver applications submitted to EMA from January 2007 through December 2013. Using baseline data from EMA, we matched product-specific waivers with their FDA equivalents during the study period. Results For single active substance products, PDCO and PeRC adopted similar opinions in 42 of 49 indications (86%). For fixed-dose combinations, PDCO and PeRC adopted similar opinions in 24 of 31 indications (77%). Conclusion Despite the different legal frameworks, criteria, and processes of determination, the waiver decisions of the 2 agencies were similar in the majority of cases. PMID:27274951

Efficient Constraint Handling in Electromagnetism-Like Algorithm for Traveling Salesman Problem with Time Windows

PubMed Central

Yurtkuran, Alkın

2014-01-01

The traveling salesman problem with time windows (TSPTW) is a variant of the traveling salesman problem in which each customer should be visited within a given time window. In this paper, we propose an electromagnetism-like algorithm (EMA) that uses a new constraint handling technique to minimize the travel cost in TSPTW problems. The EMA utilizes the attraction-repulsion mechanism between charged particles in a multidimensional space for global optimization. This paper investigates the problem-specific constraint handling capability of the EMA framework using a new variable bounding strategy, in which real-coded particle's boundary constraints associated with the corresponding time windows of customers, is introduced and combined with the penalty approach to eliminate infeasibilities regarding time window violations. The performance of the proposed algorithm and the effectiveness of the constraint handling technique have been studied extensively, comparing it to that of state-of-the-art metaheuristics using several sets of benchmark problems reported in the literature. The results of the numerical experiments show that the EMA generates feasible and near-optimal results within shorter computational times compared to the test algorithms. PMID:24723834

External Memory Aid Preferences of Individuals with Mild Memory Impairments.

PubMed

Lanzi, Alyssa; Wallace, Sarah E; Bourgeois, Michelle S

2018-07-01

Individuals with mild memory impairments often rely on external memory aids (EMAs) to compensate for impaired cognitive abilities and to support independent completion of activities of daily living. These strategies are evidence based; however, professionals have limited knowledge regarding individual preferences and guidance on how to incorporate a person-centered approach into the EMA development phase. The purpose of the current study was to qualitatively investigate individuals' preferences and experiences as they relate to EMAs. Data analysis included (1) evaluation of a posttreatment questionnaire to explore individual strategy preferences following intervention and (2) evaluation of group intervention videos using thematic coding to investigate individuals' experiences with strategies during intervention. Results suggest that older adults with mild memory impairments have unique preferences and experiences, despite limited variability in demographic characteristics. Some themes that emerged included memory ability awareness and attitudes toward technology. Within a person-centered approach, skilled professionals must consider individuals' unique needs, preferences, and experiences when developing strategies throughout the continuum of care to promote sustained EMA use within everyday settings. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

A Comparison of Affect Ratings Obtained with Ecological Momentary Assessment and the Day Reconstruction Method

PubMed Central

Dockray, Samantha; Grant, Nina; Stone, Arthur A.; Kahneman, Daniel; Wardle, Jane

2010-01-01

Measurement of affective states in everyday life is of fundamental importance in many types of quality of life, health, and psychological research. Ecological momentary assessment (EMA) is the recognized method of choice, but the respondent burden can be high. The day reconstruction method (DRM) was developed by Kahneman and colleagues (Science, 2004, 306, 1776–1780) to assess affect, activities and time use in everyday life. We sought to validate DRM affect ratings by comparison with contemporaneous EMA ratings in a sample of 94 working women monitored over work and leisure days. Six EMA ratings of happiness, tiredness, stress, and anger/frustration were obtained over each 24 h period, and were compared with DRM ratings for the same hour, recorded retrospectively at the end of the day. Similar profiles of affect intensity were recorded with the two techniques. The between-person correlations adjusted for attenuation ranged from 0.58 (stress, working day) to 0.90 (happiness, leisure day). The strength of associations was not related to age, educational attainment, or depressed mood. We conclude that the DRM provides reasonably reliable estimates both of the intensity of affect and variations in affect over the day, so is a valuable instrument for the measurement of everyday experience in health and social research. PMID:21113328

Kinematic analysis of jaw function in children following traumatic brain injury.

PubMed

Loh, E W L; Goozée, J V; Murdoch, B E

2005-07-01

To investigate jaw movements in children following traumatic brain injury (TBI) during speech using electromagnetic articulography (EMA). Jaw movements of two non-dysarthric children (aged 12.75 and 13.08 years) who had sustained a TBI were recorded using the AG-100 EMA system (Carstens Medizineletronik) during word-initial consonant productions. Mean quantitative kinematic parameters and coefficient of variation (variability) values were calculated and individually compared to the mean values obtained by a group of six control children (mean age 12.57 years, SD 1.52). The two children with TBI exhibited word-initial consonant jaw movement durations that were comparable to the control children, with sub-clinical reductions in speed being offset by reduced distances. Differences were observed between the two children in jaw kinematic variability, with one child exhibiting increased variability, while the other child demonstrated reduced or comparable variability compared to the control group. Possible sub-clinical impairments of jaw movement for speech were exhibited by two children who had sustained a TBI, providing insight into the consequences of TBI on speech motor control development.

Developing smartphone apps for behavioural studies: The AlcoRisk app case study.

PubMed

Smith, Anthony; de Salas, Kristy; Lewis, Ian; Schüz, Benjamin

2017-08-01

Smartphone apps have emerged as valuable research tools to sample human behaviours at their time of occurrence within natural environments. Human behaviour sampling methods, such as Ecological Momentary Assessment (EMA), aim to facilitate research that is situated in ecologically valid real world environments rather than laboratory environments. Researchers have trialled a range of EMA smartphone apps to sample human behaviours such as dieting, physical activity and smoking. Software development processes for EMA smartphones apps, however, are not widely documented with little guidance provided for the integration of complex multidisciplinary behavioural and technical fields. In this paper, the AlcoRisk app for studying alcohol consumption and risk taking tendencies is presented alongside a software development process that integrates these multidisciplinary fields. The software development process consists of three stages including requirements analysis, feature and interface design followed by app implementation. Results from a preliminary feasibility study support the efficacy of the AlcoRisk app's software development process. Copyright © 2017 Elsevier Inc. All rights reserved.

The dependence of Islamic and conventional stocks: A copula approach

NASA Astrophysics Data System (ADS)

Razak, Ruzanna Ab; Ismail, Noriszura

2015-09-01

Recent studies have found that Islamic stocks are dependent on conventional stocks and they appear to be more risky. In Asia, particularly in Islamic countries, research on dependence involving Islamic and non-Islamic stock markets is limited. The objective of this study is to investigate the dependence between financial times stock exchange Hijrah Shariah index and conventional stocks (EMAS and KLCI indices). Using the copula approach and a time series model for each marginal distribution function, the copula parameters were estimated. The Elliptical copula was selected to present the dependence structure of each pairing of the Islamic stock and conventional stock. Specifically, the Islamic versus conventional stocks (Shariah-EMAS and Shariah-KLCI) had lower dependence compared to conventional versus conventional stocks (EMAS-KLCI). These findings suggest that the occurrence of shocks in a conventional stock will not have strong impact on the Islamic stock.

Ecological momentary assessment: what it is and why it is a method of the future in clinical psychopharmacology

PubMed Central

Moskowitz, Debbie S.; Young, Simon N.

2006-01-01

Current methods of assessment in clinical psychopharmacology have several serious disadvantages, particularly for the study of social functioning. We aimed to review the strengths and weaknesses of current methods used in clinical psychopharmacology and to compare them with a group of methods, developed by personality/social psychologists, termed ecological momentary assessment (EMA), which permit the research participant to report on symptoms, affect and behaviour close in time to experience and which sample many events or time periods. EMA has a number of advantages over more traditional methods for the assessment of patients in clinical psychopharmacological studies. It can both complement and, in part, replace existing methods. EMA methods will permit more sensitive assessments and will enable more wide-ranging and detailed measurements of mood and behaviour. These types of methods should be adopted more widely by clinical psychopharmacology researchers. PMID:16496031

Tests for Serum Transglutaminase and Endomysial Antibodies Do Not Detect Most Patients With Celiac Disease and Persistent Villous Atrophy on Gluten-free Diets: a Meta-analysis.

PubMed

Silvester, Jocelyn A; Kurada, Satya; Szwajcer, Andrea; Kelly, Ciarán P; Leffler, Daniel A; Duerksen, Donald R

2017-09-01

Tests to measure serum endomysial antibodies (EMA) and antibodies to tissue transglutaminase (tTG) were developed to screen for celiac disease in patients consuming gluten. However, they are commonly used to monitor patients on a gluten-free diet (GFD). We conducted a meta-analysis to assess the sensitivity and specificity of tTG IgA and EMA IgA assays in identifying patients with celiac disease who have persistent villous atrophy despite a GFD. We searched PUBMED, EMBASE, BIOSIS, SCOPUS, clinicaltrials.gov, Science Citation Index, and Cochrane Library databases through November 2016. Inclusion criteria were studies of subjects with biopsy-confirmed celiac disease, follow-up biopsies, and measurement of serum antibodies on a GFD, biopsy performed on subjects regardless of symptoms, or antibody test results. Our analysis excluded subjects with refractory celiac disease, undergoing gluten challenge, or consuming a prescribed oats-containing GFD. Tests were considered to have positive or negative findings based on manufacturer cut-off values. Villous atrophy was defined as a Marsh 3 lesion or villous height:crypt depth ratio below 3.0. We constructed forest plots to determine the sensitivity and specificity of detection for individual studies. For the meta-analysis, a bivariate random effects model was used to jointly model sensitivity and specificity. Our search identified 5408 unique citations. Following review of abstracts, 442 articles were reviewed in detail. Only 26 studies (6 of tTG assays, 15 of EMA assays, and 5 of tTG and EMA assays) met our inclusion criteria. The most common reason studies were excluded from our analysis was inability to cross-tabulate histologic and serologic findings. The serum assays identified patients with persistent villous atrophy with high levels of specificity: 0.83 for the tTG IgA assay (95% CI, 0.79-0.87) and 0.91 for the EMA IgA assay (95% CI, 0.87-0.94). However, they detected villous atrophy with low levels of sensitivity: 0.50 for the tTG IgA assay (95% CI, 0.41-0.60) and 0.45 for the EMA IgA assay (95% CI, 0.34-0.57). The tests had similar levels of performance in pediatric and adult patients. In a meta-analysis of patients with biopsy-confirmed celiac disease undergoing follow-up biopsy on a GFD, we found that tests for serum tTG IgA and EMA IgA levels had low sensitivity (below 50%) in detection of persistent villous atrophy. We need more-accurate non-invasive markers of mucosal damage in children and adults with celiac disease who are following a GFD. Copyright © 2017 AGA Institute. Published by Elsevier Inc. All rights reserved.

Follow-up of pediatric celiac disease: value of antibodies in predicting mucosal healing, a prospective cohort study.

PubMed

Vécsei, Edith; Steinwendner, Stephanie; Kogler, Hubert; Innerhofer, Albina; Hammer, Karin; Haas, Oskar A; Amann, Gabriele; Chott, Andreas; Vogelsang, Harald; Schoenlechner, Regine; Huf, Wolfgang; Vécsei, Andreas

2014-02-13

In diagnosing celiac disease (CD), serological tests are highly valuable. However, their role in following up children with CD after prescription of a gluten-free diet is unclear. This study aimed to compare the performance of antibody tests in predicting small-intestinal mucosal status in diagnosis vs. follow-up of pediatric CD. We conducted a prospective cohort study at a tertiary-care center. 148 children underwent esophohagogastroduodenoscopy with biopsies either for symptoms ± positive CD antibodies (group A; n = 95) or following up CD diagnosed ≥ 1 year before study enrollment (group B; n = 53). Using biopsy (Marsh ≥ 2) as the criterion standard, areas under ROC curves (AUCs) and likelihood-ratios were calculated to estimate the performance of antibody tests against tissue transglutaminase (TG2), deamidated gliadin peptide (DGP) and endomysium (EMA). AUCs were higher when tests were used for CD diagnosis vs. follow-up: 1 vs. 0.86 (P = 0.100) for TG2-IgA, 0.85 vs. 0.74 (P = 0.421) for TG2-IgG, 0.97 vs. 0.61 (P = 0.004) for DPG-IgA, and 0.99 vs. 0.88 (P = 0.053) for DPG-IgG, respectively. Empirical power was 85% for the DPG-IgA comparison, and on average 33% (range 13-43) for the non-significant comparisons. Among group B children, 88.7% showed mucosal healing (median 2.2 years after primary diagnosis). Only the negative likelihood-ratio of EMA was low enough (0.097) to effectively rule out persistent mucosal injury. However, out of 12 EMA-positive children with mucosal healing, 9 subsequently turned EMA-negative. Among the CD antibodies examined, negative EMA most reliably predict mucosal healing. In general, however, antibody tests, especially DPG-IgA, are of limited value in predicting the mucosal status in the early years post-diagnosis but may be sufficient after a longer period of time.

The contributions of the European Medicines Agency and its pediatric committee to the fight against childhood leukemia.

PubMed

Rose, Klaus; Walson, Philip D

2015-01-01

Although the diagnosis of childhood leukemia is no longer a death sentence, too many patients still die, more with acute myeloid leukemia than with acute lymphoblastic leukemia. The European Union pediatric legislation was introduced to improve pharmaceutical treatment of children, but some question whether the European Medicines Agency (EMA) approach is helping children with leukemia. Some have even suggested that the decisions of EMA pediatric committee (PDCO) are counterproductive. This study was designed to investigate the impact of PDCO-issued pediatric investigation plans (PIPs) for leukemia drugs. All PIPs listed under "oncology" were downloaded from the EMA website. Non-leukemia decisions including misclassifications, waivers (no PIP), and solid tumors were discarded. The leukemia decisions were analyzed, compared to pediatric leukemia trials in the database http://www.clinicaltrials.gov, and discussed in the light of current literature. The PDCO leukemia decisions demand clinical trials in pediatric leukemia for all new adult drugs without prioritization. However, because leukemia in children is different and much rarer than in adults, these decisions have resulted in proposed studies that are scientifically and ethically questionable. They are also unnecessary, since once promising new compounds are approved for adults, more appropriate, prioritized pediatric leukemia trials are initiated worldwide without PDCO involvement. EMA/PDCO leukemia PIPs do little to advance the treatment of childhood leukemia. The unintended negative effects of the flawed EMA/PDCO's standardized requesting of non-prioritized testing of every new adult leukemia drug in children with relapsed or refractory disease expose these children to questionable trials, and could undermine public trust in pediatric clinical research. Institutions, investigators, and ethics committees/institutional review boards need to be skeptical of trials triggered by PDCO. New, better ways to facilitate drug development for pediatric leukemia are needed.

Hunger and binge eating: a meta-analysis of studies using ecological momentary assessment.

PubMed

Haedt-Matt, Alissa A; Keel, Pamela K

2011-11-01

Binge eating has been associated with increased hunger, suggesting a role for impaired appetite regulation. Ecological momentary assessment (EMA) is ideally suited to examine whether hunger is a precipitant of binge eating but results from such studies have not been systematically reviewed. This study provides a meta-analysis of EMA studies that have examined hunger as an antecedent of binge eating. Electronic database and manual searches produced seven EMA studies with N = 180 participants. Meta-analyses were conducted to compare: (1) pre-binge eating hunger to average ratings of hunger, and (2) pre-binge eating hunger to hunger before regular eating. Across studies, hunger was significantly greater before binge eating compared with average hunger ratings, but was significantly lower before binge eating compared with before other eating episodes. Excessive hunger does not appear to be a precipitant of binge eating because higher levels of hunger are observed before regular eating episodes. However, lower hunger before food consumption may contribute to the experience of a particular eating episode as a binge. Copyright © 2010 Wiley Periodicals, Inc.

Exoskeletal meal assistance system (EMAS II) for progressive muscle dystrophy patient.

PubMed

Hasegawa, Yasuhisa; Oura, Saori

2011-01-01

This paper introduces a 4-DOFs exoskeletal meal assistance system (EMAS II) for progressive muscle dystrophy patient. It is generally better for the patient to use his/her hands by himself in daily life because active works maintain level of residual functions, health and initiative of him/her. The EMAS II that has a new joystick-type user interface device and three-DOFs on a shoulder part is enhanced for an easier operation and more comfortable support on eating, as the succeeding model of the previous system that has two-DOFs on a shoulder. In order to control the 4-DOFs system by the simple user interface device, the EMAS II simulates upper limb motion patterns of a healthy person. The motion patterns are modeled by extracting correlations between the height of a user's wrist joint and that of the user's elbow joint at the table. Moreover, the EMAS II automatically brings user's hand up to his/her mouth or back to a table when he/she pushes a preset switch on the interface device. Therefore a user has only to control a position of his/her wrist to pick or scoop foods and then flip the switch to start automatic mode, while a height of the elbow joint is automatically controlled by the EMAS II itself. The results of experiments, where a healthy subject regarded as a muscle dystrophy patient eats a meal with EMAS II, show that the subject finished her meal in a natural way in 18 minutes 40 seconds which was within a recommended time of 30 minutes. © 2011 IEEE

Development of an Ecological Momentary Assessment Mobile App for a Low-Literacy, Mexican American Population to Collect Disordered Eating Behaviors

PubMed Central

Stein, Karen F; Chaudry, Beenish; Trabold, Nicole

2016-01-01

Background Ecological momentary assessment (EMA) is a popular method for understanding population health in which participants report their experiences while in naturally occurring contexts in order to increase the reliability and ecological validity of the collected data (as compared to retrospective recall). EMA studies, however, have relied primarily on text-based questionnaires, effectively eliminating low-literacy populations from the samples. Objective To provide a case study of design of an EMA mobile app for a low-literacy population. In particular, we present the design process and final design of an EMA mobile app for low literate, Mexican American women to record unhealthy eating and weight control behaviors (UEWCBs). Methods An iterative, user-centered design process was employed to develop the mobile app. An existing EMA protocol to measure UEWCBs in college-enrolled Mexican American women was used as the starting point for the application. The app utilizes an icon interface, with optional audio prompts, that is culturally sensitive and usable by a low-literacy population. A total of 41 women participated over the course of 4 phases of the design process, which included 2 interview and task-based phases (n=8, n=11), focus groups (n=15), and a 5-day, in situ deployment (n=7). Results Participants’ mental models of UEWCBs differed substantially from prevailing definitions found in the literature, prompting a major reorganization of the app interface. Differences in health literacy and numeracy were better identified with the Newest Vital Sign tool, as compared with the Short Assessment of Health Literacy tool. Participants had difficulty imagining scenarios in the interviews to practice recording a specific UEWCB; instead, usability was best tested in situ. Participants were able to use the EMA mobile app over the course of 5 days to record UEWCBs. Conclusions Results suggest that the iterative, user-centered design process was essential for designing the app to be made usable by the target population. Simply taking the protocol designed for a higher-literacy population and replacing words with icons and/or audio would have been unsuccessful with this population. PMID:27418020

The promise of wearable sensors and ecological momentary assessment measures for dynamical systems modeling in adolescents: a feasibility and acceptability study.

PubMed

Brannon, Erin E; Cushing, Christopher C; Crick, Christopher J; Mitchell, Tarrah B

2016-12-01

Intervention development can be accelerated by using wearable sensors and ecological momentary assessment (EMA) to study how behaviors change within a person. The purpose of this study was to determine the feasibility and acceptability of a novel, intensive EMA method for assessing physiology, behavior, and psychosocial variables utilizing two objective sensors and a mobile application (app). Adolescents (n = 20) enrolled in a 20-day EMA protocol. Participants wore a physiological monitor and an accelerometer that measured sleep and physical activity and completed four surveys per day on an app. Participants provided approximately 81 % of the expected survey data. Participants were compliant to the wrist-worn accelerometer (75.3 %), which is a feasible measurement of physical activity/sleep (74.1 % complete data). The data capture (47.8 %) and compliance (70.28 %) with the physiological monitor were lower than other study variables. The findings support the use of an intensive assessment protocol to study real-time relationships between biopsychosocial variables and health behaviors.

Examining Affect and Perfectionism in Relation to Eating Disorder Symptoms among Women with Anorexia Nervosa

PubMed Central

Lavender, Jason M.; Mason, Tyler B.; Utzinger, Linsey M.; Wonderlich, Stephen A.; Crosby, Ross D.; Engel, Scott G.; Mitchell, James E.; Le Grange, Daniel; Crow, Scott J.; Peterson, Carol B.

2016-01-01

This study examined personality and affective variables in relation to eating disorder symptoms in anorexia nervosa (AN). Women (N=118) with DSM-IV AN completed baseline questionnaires (Beck Depression Inventory, Frost Multidimensional Perfectionism Scale) and interviews (Eating Disorder Examination, Yale-Brown-Cornell Eating Disorder Scale), followed by two weeks of ecological momentary assessment (EMA) involving multiple daily reports of affective states and eating disorder behaviors. Hierarchical regression analyses were conducted using eating disorder symptoms as dependent variables (i.e., EMA binge eating, EMA self-induced vomiting, eating disorder rituals, eating disorder preoccupations, dietary restraint). Predictor variables were maladaptive perfectionism (baseline), depressive symptoms (baseline), and affect lability (EMA). Results revealed that affect lability was independently associated with binge eating, whereas depressive symptoms were independently associated with self-induced vomiting. Depressive symptoms were independently associated with eating disorder rituals, whereas both depressive symptoms and maladaptive perfectionism were independently associated with eating disorder preoccupations. Finally, maladaptive perfectionism and affect lability were both independently associated with dietary restraint. This pattern of findings suggests the importance of affective and personality constructs in relation to eating disorder symptoms in AN and may highlight the importance of targeting these variables in the context of treatment. PMID:27208513

The Food and Drug Administration reports provided more data but were more difficult to use than the European Medicines Agency reports.

PubMed

Schroll, Jeppe Bennekou; Abdel-Sattar, Maher; Bero, Lisa

2015-01-01

To compare the accessibility, comprehensiveness, and usefulness of data available from the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) drug reports. This is a cross-sectional study. All new molecular drugs approved between January 1, 2011 and December 31, 2012 from the FDA and EMA Web sites were eligible. We included 27 drug reports. Most were searchable, but the FDA table of contents did not match the file's page numbers. Several FDA documents must be searched compared with a single EMA document, but the FDA reports contain more summary data on harms. Detailed information about harms was reported for 93% of the FDA reports (25 of 27 reports) and 26% of the EMA reports (7 of 27 reports). The reports contained information about trial methodology but did not include trial registry IDs or investigator names. All reports but one contained sufficient information to be used in a meta-analysis. Detailed data on efficacy and harms are available at the two agencies. The FDA has more summary data on harms, but the documents are harder to navigate. Published by Elsevier Inc.

Attenuation of the Infiltration of Angiotensin II Expressing CD3+ T-Cells and the Modulation of Nerve Growth Factor in Lumbar Dorsal Root Ganglia – A Possible Mechanism Underpinning Analgesia Produced by EMA300, An Angiotensin II Type 2 (AT2) Receptor Antagonist

PubMed Central

Khan, Nemat; Muralidharan, Arjun; Smith, Maree T.

2017-01-01

Recent preclinical and proof-of-concept clinical studies have shown promising analgesic efficacy of selective small molecule angiotensin II type 2 (AT2) receptor antagonists in the alleviation of peripheral neuropathic pain. However, their cellular and molecular mechanism of action requires further investigation. To address this issue, groups of adult male Sprague–Dawley rats with fully developed unilateral hindpaw hypersensitivity, following chronic constriction injury (CCI) of the sciatic nerve, received a single intraperitoneal bolus dose of the small molecule AT2 receptor antagonist, EMA300 (10 mg kg-1), or vehicle. At the time of peak EMA300-mediated analgesia (∼1 h post-dosing), groups of CCI-rats administered either EMA300 or vehicle were euthanized. A separate group of rats that underwent sham surgery were also included. The lumbar (L4–L6) dorsal root ganglia (DRGs) were obtained from all experimental cohorts and processed for immunohistochemistry and western blot studies. In vehicle treated CCI-rats, there was a significant increase in the expression levels of angiotensin II (Ang II), but not the AT2 receptor, in the ipsilateral lumbar DRGs. The elevated levels of Ang II in the ipsilateral lumbar DRGs of CCI-rats were at least in part contributed by CD3+ T-cells, satellite glial cells (SGCs) and subsets of neurons. Our findings suggest that the analgesic effect of EMA300 in CCI-rats involves multimodal actions that appear to be mediated at least in part by a significant reduction in the otherwise increased expression levels of Ang II as well as the number of Ang II-expressing CD3+ T-cells in the ipsilateral lumbar DRGs of CCI-rats. Additionally, the acute anti-allodynic effects of EMA300 in CCI-rats were accompanied by rescue of the otherwise decreased expression of mature nerve growth factor (NGF) in the ipsilateral lumbar DRGs of CCI-rats. In contrast, the increased expression levels of TrkA and glial fibrillary acidic protein in the ipsilateral lumbar DRGs of vehicle-treated CCI-rats were not attenuated by a single bolus dose of EMA300. Consistent with our previous findings, there was also a significant decrease in the augmented levels of the downstream mediators of Ang II/AT2 receptor signaling, i.e., phosphorylated-p38 mitogen-activated protein kinase (MAPK) and phosphorylated-p44/p42 MAPK, in the ipsilateral lumbar DRGs. PMID:29200998

Gender and stress in predicting depressive symptoms following stroke.

PubMed

Mazure, Carolyn M; Weinberger, Andrea H; Pittman, Brian; Sibon, Igor; Swendsen, Joel

2014-01-01

Post-stroke depression (PSD) is associated with poor clinical and functional outcomes, and women are likely to experience PSD more than men. Although stress is related to depression, and women report greater emotional reactivity to stressful life events, the link between stress and gender is yet to be examined relative to PSD. Further, electronic momentary assessment (EMA), a mobile technology, has not been used to assess stressful life events and PSD in real time and in the natural environments of daily life. The purpose of the current study was to examine gender differences in the relationship of stress and PSD using EMA. Individuals admitted to the Stroke Center at the University of Bordeaux were contacted for participation in a prospective study of symptoms and experiences in daily life using ambulatory monitoring. Forty-three post-stroke patients (47% female) completed electronic assessments of life events, perceived stress, and depressive symptoms (i.e., sad mood, anhedonia, fatigue, concentration difficulties, appetite change, negative thoughts, hopelessness) during their daily life for one week. Patients also completed a clinician-administered standardized depression scale at baseline and three-month follow-up. Using EMA, participants responded to 83.7% of the electronic interviews for a total of 1,140 observations across diverse daily life contexts. Stressful events of any degree of negativity were reported at over one-third (37.3%) of all EMA assessments. The severity of depressive symptoms as assessed in daily life through EMA was greater in women following stroke than in men. Further, there was a significant association between EMA-assessed depressive symptoms and daily life stress for women, but not men. This association was due primarily to three specific depressive symptoms: sad mood, fatigue, and appetite change. No difference was observed between men and women in standardized depression assessments administered during clinic visits at baseline or three-month follow-up. Greater reactivity to stressful life events and a link between stress reactivity and depressive symptoms were found in female as compared to male post-stroke patients. Gender differences in depressive symptoms were identified using EMA data collected during daily life as contrasted with the use of a standard assessment during clinic visits. Mobile technologies may help to identify important real-time behaviors and symptoms that are not observable by standard clinical assessments employed at regular clinic visits. Further, future research should examine the overall and gender-specific benefits of stress-based interventions to reduce the risk of PSD for adults. © 2014 S. Karger AG, Basel.

Ecologic Momentary Assessment: Perspectives on Applications and Opportunities in Research and Practice Regarding Nutrition Behaviors.

PubMed

Hand, Rosa K; Perzynski, Adam T

2016-09-01

Retrospective self-reported data have limitations, making it important to evaluate alternative forms of measurement for nutrition behaviors. Ecological momentary assessment (EMA) attempts to overcome the challenges of recalled data with real-time data collection in a subject's natural environment, often leveraging technology. This perspective piece 1) introduces the concepts and terminology of EMA, 2) provides an overview of the methodological and analytical considerations, 3) gives examples of past research using EMA, and 4) suggests new opportunities (including combining assessment and intervention) and limitations (including the need for technology) for the application of EMA to research and practice regarding nutrition behaviors. Copyright © 2016 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.

Muscle-Specific Effective Mechanical Advantage and Joint Impulse in Weightlifting.

PubMed

Kipp, Kristof; Harris, Chad

2017-07-01

Kipp, K, and Harris, C. Muscle-specific effective mechanical advantage and joint impulse in weightlifting. J Strength Cond Res 31(7): 1905-1910, 2017-Lifting greater loads during weightlifting exercises may theoretically be achieved through increasing the magnitudes of net joint impulses or manipulating the joints' effective mechanical advantage (EMA). The purpose of this study was to investigate muscle-specific EMA and joint impulse as well as impulse-momentum characteristics of the lifter-barbell system across a range of external loads during the execution of the clean. Collegiate-level weightlifters performed submaximal cleans at 65, 75, and 85% of their 1-repetition maximum (1-RM), whereas data from a motion analysis system and a force plate were used to calculate lifter-barbell system impulse and velocity, as well as net extensor impulse generated at the hip, knee, and ankle joints and the EMA of the gluteus maximus, hamstrings, quadriceps, and triceps surae muscles. The results indicated that the lifter-barbell system impulse did not change as load increased, whereas the velocity of the lifter-barbell system decreased with greater load. In addition, the net extensor impulse at all joints increased as load increased. The EMA of all muscles did not, however, change as load increased. The load-dependent effects on the impulse-velocity characteristics of the lifter-barbell system may reflect musculoskeletal force-velocity behaviors, and may further indicate that the weightlifting performance is limited by the magnitude of ground reaction force impulse. In turn, the load-dependent effects observed at the joint level indicated that lifting greater loads were due to greater net extensor impulses generated at the joints of the lower extremity and not greater EMAs of the respective extensor muscles. In combination, these results suggest that lifting greater external loads during the clean is due to the ability to generate large extensor joint impulses, rather than manipulate EMA.

Daily Associations of Stress and Eating in Mother-Child Dyads.

PubMed

Dunton, Genevieve F; Dzubur, Eldin; Huh, Jimi; Belcher, Britni R; Maher, Jaclyn P; O'Connor, Sydney; Margolin, Gayla

2017-06-01

This study used Ecological Momentary Assessment (EMA) in mother-child dyads to examine the day-level associations of stress and eating. Mothers and their 8- to 12-year-old children ( N = 167 dyads) completed between three (weekday) and eight (weekend) EMA survey prompts per day at random nonschool times across 8 days. EMA measured perceived stress, and past 2-hour healthy (i.e., fruit and vegetables) and unhealthy (e.g., pastries/sweets, soda/energy drinks) eating. Children reported more healthy and unhealthy eating on days when their mothers also engaged in more healthy and unhealthy eating, respectively. On days when mothers' perceived stress was greater than usual, they reported more healthy eating. Eating behaviors were coupled between mothers and children at the day level. Mothers' stress was related to their own eating but not to children's eating.

No haste, more taste: An EMA study of the effects of stress, negative and positive emotions on eating behavior.

PubMed

Reichenberger, Julia; Kuppens, Peter; Liedlgruber, Michael; Wilhelm, Frank H; Tiefengrabner, Martin; Ginzinger, Simon; Blechert, Jens

2018-01-01

Stress and emotions alter eating behavior in several ways: While experiencing negative or positive emotions typically leads to increased food intake, stress may result in either over- or undereating. Several participant characteristics, like gender, BMI and restrained, emotional, or external eating styles seem to influence these relationships. Thus far, most research relied on experimental laboratory studies, thereby reducing the complexity of real-life eating episodes. The aim of the present study was to delineate the effects of stress, negative and positive emotions on two key facets of eating behavior, namely taste- and hunger-based eating, in daily life using ecological momentary assessment (EMA). Furthermore, the already mentioned individual differences as well as time pressure during eating, an important but unstudied construct in EMA studies, were examined. Fifty-nine participants completed 10days of signal-contingent sampling and data were analyzed using multilevel modeling. Results revealed that higher stress led to decreased taste-eating which is in line with physiological stress-models. Time pressure during eating resulted in less taste- and more hunger-eating. In line with previous research, stronger positive emotions went along with increased taste-eating. Emotional eating style moderated the relationship between negative emotions and taste-eating as well as hunger-eating. BMI moderated the relationship between negative as well as positive emotions and hunger-eating. These findings emphasize the importance of individual differences for understanding eating behavior in daily life. Experienced time pressure may be an important aspect for future EMA eating studies. Copyright © 2016 Elsevier B.V. All rights reserved.

Momentary assessment of contextual influences on affective response during physical activity.

PubMed

Dunton, Genevieve Fridlund; Liao, Yue; Intille, Stephen; Huh, Jimi; Leventhal, Adam

2015-12-01

Higher positive and lower negative affective response during physical activity may reinforce motivation to engage in future activity. However, affective response during physical activity is typically examined under controlled laboratory conditions. This research used ecological momentary assessment (EMA) to examine social and physical contextual influences on momentary affective response during physical activity in naturalistic settings. Participants included 116 adults (mean age = 40.3 years, 73% female) who completed 8 randomly prompted EMA surveys per day for 4 days across 3 semiannual waves. EMA surveys measured current activity level, social context, and physical context. Participants also rated their current positive and negative affect. Multilevel models assessed whether momentary physical activity level moderated differences in affective response across contexts controlling for day of the week, time of day, and activity intensity (measured by accelerometer). The Activity Level × Alone interaction was significant for predicting positive affect (β = -0.302, SE = 0.133, p = .024). Greater positive affect during physical activity was reported when with other people (vs. alone). The Activity Level × Outdoors interaction was significant for predicting negative affect (β = -0.206, SE = 0.097, p = .034). Lower negative affect during physical activity was reported outdoors (vs. indoors). Being with other people may enhance positive affective response during physical activity, and being outdoors may dampen negative affective response during physical activity. (c) 2015 APA, all rights reserved).

Feasibility and Acceptability of Smartphone-Based Ecological Momentary Assessment of Alcohol Use Among African American Men Who Have Sex With Men in Baltimore.

PubMed

Yang, Cui; Linas, Beth; Kirk, Gregory; Bollinger, Robert; Chang, Larry; Chander, Geetanjali; Siconolfi, Daniel; Braxton, Sharif; Rudolph, Abby; Latkin, Carl

2015-06-17

Alcohol use is a risk factor for the acquisition of human immunodeficiency virus (HIV) among African American men who have sex with men (MSM). Mobile phone-based ecological momentary assessments (EMA) could minimize bias due to retrospective recall and thus provide a better understanding of the social and structural context of alcohol use and its relationship with HIV-related risk behaviors in this population as well as other highly stigmatized populations. We describe the study design and the implementation, feasibility, reactivity, and acceptability of an EMA study of alcohol use and HIV-related behaviors among African American MSM in Baltimore. Participants were recruited through flyers and word-of-mouth in Baltimore from September 2013 to November 2014. Each participant was loaned an Android smartphone and instructed to respond to multiple prompts from the mobile app for 4 weeks. Data were collected through (1) random prompts delivered three times daily assessing participants' location, activity, mood, and social context, (2) daily prompts capturing drinking and sex events occurring in the past 24 hours, and (3) event-contingent responses collecting participants' self-reported episodes of drinking. A total of 16 participants enrolled in the study. The current analyses focused on 15 participants who completed at least 24 days of follow-up (mean follow-up time 29 days; range 24-35 days). Study participants (N=15) were a median 38 years of age (range 27-62 years) with low levels of income and educational attainment. Ten individuals self-reported living with HIV/AIDS, over half reported drinking alcohol at least 2-3 times a week, and a third reported binge drinking (ie, 6 or more drinks on one occasion) on a weekly basis. Based on the Alcohol Use Disorders Identification Test (AUDIT) score, nearly half were classified as hazardous drinkers (score 8-15) and a fifth were likely dependent (score ≥16). A total of 140 participant-initiated events were reported, and 75% of 1308 random prompts and 81% of 436 daily prompts delivered were answered. Of seven devices used during the study, five were reported lost by participants. We did not observe strong reactivity effects, and self-reported acceptability to study procedures was uniformly favorable. This study provides evidence to support the feasibility and acceptability of using EMA methods for collecting data on alcohol use among African American men who have sex with men living in urban settings. These data provide the basis for future studies of EMA-informed mHealth interventions to promote the reduction of substance use and HIV risk-taking behaviors among African American MSM living in urban settings.

DSM-IV-defined anorexia nervosa versus subthreshold anorexia nervosa (EDNOS-AN).

PubMed

Le Grange, Daniel; Crosby, Ross D; Engel, Scott G; Cao, Li; Ndungu, Alfred; Crow, Scott J; Peterson, Carol B; Mitchell, James E; Wonderlich, Stephen A

2013-01-01

Eating disorder not otherwise specified (EDNOS) is the most prevalent eating disorder, yet its heterogeneity begs less reliance on this broad diagnostic category. The purpose of this study was to compare women with anorexia nervosa (AN) and EDNOS, AN type (EDNOS-AN) from a multisite study on eating-related and general psychopathology measures. One hundred eighteen participants (n = 59 with DSM-IV AN, n = 59 with EDNOS-AN) completed structured interviews, questionnaires and a physical examination at baseline. In addition, participants carried a handheld palm pilot computer for 2 weeks to provide ecological momentary assessment (EMA) information about mood and eating disorder behaviours. No significant differences between AN and EDNOS-AN were found on the self-report and interview measures, or on the EMA mood assessments. The only differences to emerge were that participants with AN reported higher rates of binge eating and purging on EMA compared with those with EDNOS-AN, whereas EDNOS-AN reported higher rates of checking thighs and joints on EMA compared with those with AN. For the physiological parameters, AN presented with lower white blood cell counts compared with EDNOS-AN. Findings highlight the clinical significance of EDNOS-AN and support a closer look at the definition of AN as proposed by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition. Copyright © 2012 John Wiley & Sons, Ltd and Eating Disorders Association.

Energy Materials Coordinating Committee (EMaCC). Annual technical report, Fiscal Year 2001

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

None, None

2002-08-01

The DOE Energy Materials Coordinating Committee (EMaCC) serves primarily to enhance coordination among the Department's materials programs and to further effective use of materials expertise within the Department. These functions are accomplished through the exchange of budgetary and planning information among program managers and through technical meetings/workshops on selected topics involving both DOE and major contractors. In addition, EMaCC assists in obtaining materials-related inputs for both intra- and interagency compilations.

Evaluating the real-world predictive validity of the Body Image Quality of Life Inventory using Ecological Momentary Assessment.

PubMed

Heron, Kristin E; Mason, Tyler B; Sutton, Tiphanie G; Myers, Taryn A

2015-09-01

Perceptions of physical appearance, or body image, can affect psychosocial functioning and quality of life (QOL). The present study evaluated the real-world predictive validity of the Body Image Quality of Life Inventory (BIQLI) using Ecological Momentary Assessment (EMA). College women reporting subclinical disordered eating/body dissatisfaction (N=131) completed the BIQLI and related measures. For one week they then completed five daily EMA surveys of mood, social interactions, stress, and eating behaviors on palmtop computers. Results showed better body image QOL was associated with less negative affect, less overwhelming emotions, more positive affect, more pleasant social interactions, and higher self-efficacy for handling stress. Lower body image QOL was marginally related to less overeating and lower loss of control over eating in daily life. To our knowledge, this is the first study to support the real-world predictive validity of the BIQLI by identifying social, affective, and behavioral correlates in everyday life using EMA. Copyright © 2015 Elsevier Ltd. All rights reserved.

Resonant mode controllers for launch vehicle applications

NASA Technical Reports Server (NTRS)

Schreiner, Ken E.; Roth, Mary Ellen

1992-01-01

Electro-mechanical actuator (EMA) systems are currently being investigated for the National Launch System (NLS) as a replacement for hydraulic actuators due to the large amount of manpower and support hardware required to maintain the hydraulic systems. EMA systems in weight sensitive applications, such as launch vehicles, have been limited to around 5 hp due to system size, controller efficiency, thermal management, and battery size. Presented here are design and test data for an EMA system that competes favorably in weight and is superior in maintainability to the hydraulic system. An EMA system uses dc power provided by a high energy density bipolar lithium thionyl chloride battery, with power conversion performed by low loss resonant topologies, and a high efficiency induction motor controlled with a high performance field oriented controller to drive a linear actuator.

Using experience sampling methods/ecological momentary assessment (ESM/EMA) in clinical assessment and clinical research: introduction to the special section.

PubMed

Trull, Timothy J; Ebner-Priemer, Ulrich W

2009-12-01

This article introduces the special section on experience sampling methods and ecological momentary assessment in clinical assessment. We review the conceptual basis for experience sampling methods (ESM; Csikszentmihalyi & Larson, 1987) and ecological momentary assessment (EMA; Stone & Shiffman, 1994). Next, we highlight several advantageous features of ESM/EMA as applied to psychological assessment and clinical research. We provide a brief overview of the articles in this special section, each of which focuses on 1 of the following major classes of psychological disorders: mood disorders and mood dysregulation (Ebner-Priemer & Trull, 2009), anxiety disorders (Alpers, 2009), substance use disorders (Shiffman, 2009), and psychosis (Oorschot, Kwapil, Delespaul, & Myin-Germeys, 2009). Finally, we discuss prospects, future challenges, and limitations of ESM/EMA.

An investigation into drug products withdrawn from the EU market between 2002 and 2011 for safety reasons and the evidence used to support the decision-making.

PubMed

McNaughton, Rhian; Huet, Gwenaël; Shakir, Saad

2014-01-15

The objective of this study was to determine the nature of evidence used to support the withdrawal of marketing authorisations of drug products for safety reasons throughout the European Union (EU) between 2002 and 2011. Products withdrawn, either by a medicines agency or a marketing authorisation holder, during the period 2002-2011 were identified by conducting detailed searches of the WHO, the European Medicines Agency (EMA) and national medicines agency websites throughout the EU plus Norway, Iceland and Liechtenstein. The scientific evidence used to support the decision was identified from a search within PubMed, the EMA and national medicines agencies websites. Information about spontaneous case reports entered into EudraVigilance and unavailable on the EMA website was received by email from the EMA. 19 drugs were withdrawn from the market, throughout the EU, for safety reasons from 2002 to 2011. Case reports were cited in 95% of withdrawals (18/19) and case-control studies (4/19), cohort studies (4/19), randomised controlled trials (RCTs) (12/19) or meta-analysis (5/19) were cited in 63% of withdrawals (12/19). Cardiovascular events or disorders were the main reason for withdrawal (9/19), followed by hepatic disorders (4/19) and neurological or psychiatric disorders (4/19). This study has shown that the level of evidence used to support drug withdrawal has improved during the past 10 years, with an increased use of case-control studies, cohort studies, RCTs and meta-analyses. This research has demonstrated that such studies have contributed to decision-making in almost two-thirds of cases.

Genetic Parameters of Pre-adjusted Body Weight Growth and Ultrasound Measures of Body Tissue Development in Three Seedstock Pig Breed Populations in Korea

PubMed Central

Choy, Yun Ho; Mahboob, Alam; Cho, Chung Il; Choi, Jae Gwan; Choi, Im Soo; Choi, Tae Jeong; Cho, Kwang Hyun; Park, Byoung Ho

2015-01-01

The objective of this study was to compare the effects of body weight growth adjustment methods on genetic parameters of body growth and tissue among three pig breeds. Data collected on 101,820 Landrace, 281,411 Yorkshire, and 78,068 Duroc pigs, born in Korean swine breeder farms since 2000, were analyzed. Records included body weights on test day and amplitude (A)-mode ultrasound carcass measures of backfat thickness (BF), eye muscle area (EMA), and retail cut percentage (RCP). Days to 90 kg body weight (DAYS90), through an adjustment of the age based on the body weight at the test day, were obtained. Ultrasound measures were also pre-adjusted (ABF, EMA, AEMA, ARCP) based on their test day measures. The (co)variance components were obtained with 3 multi-trait animal models using the REMLF90 software package. Model I included DAYS90 and ultrasound traits, whereas model II and III accounted DAYS90 and pre-adjusted ultrasound traits. Fixed factors were sex (sex) and contemporary groups (herd-year-month of birth) for all traits among the models. Additionally, model I and II considered a linear covariate of final weight on the ultrasound measure traits. Heritability (h2) estimates for DAYS90, BF, EMA, and RCP ranged from 0.36 to 0.42, 0.34 to 0.43, 0.20 to 0.22, and 0.39 to 0.45, respectively, among the models. The h2 estimates of DAYS90 from model II and III were also somewhat similar. The h2 for ABF, AEMA, and ARCP were 0.35 to 0.44, 0.20 to 0.25, and 0.41 to 0.46, respectively. Our heritability estimates varied mostly among the breeds. The genetic correlations (rG) were moderately negative between DAYS90 and BF (−0.29 to −0.38), and between DAYS90 and EMA (−0.16 to −0.26). BF had strong rG with RCP (−0.87 to −0.93). Moderately positive rG existed between DAYS90 and RCP (0.20 to 0.28) and between EMA and RCP (0.35 to 0.44) among the breeds. For DAYS90, model II and III, its correlations with ABF, AEMA, and ARCP were mostly low or negligible except the rG between DAYS90 and AEMA from model III (0.27 to 0.30). The rG between AEMA and ABF and between AEMA and ARCP were moderate but with negative and positive signs, respectively; also reflected influence of pre-adjustments. However, the rG between BF and RCP remained non-influential to trait pre-adjustments or covariable fits. Therefore, we conclude that ultrasound measures taken at a body weight of about 90 kg as the test final should be adjusted for body weight growth. Our adjustment formulas, particularly those for BF and EMA, should be revised further to accommodate the added variation due to different performance testing endpoints with regard to differential growth in body composition. PMID:26580436

Genetic Parameters of Pre-adjusted Body Weight Growth and Ultrasound Measures of Body Tissue Development in Three Seedstock Pig Breed Populations in Korea.

PubMed

Choy, Yun Ho; Mahboob, Alam; Cho, Chung Il; Choi, Jae Gwan; Choi, Im Soo; Choi, Tae Jeong; Cho, Kwang Hyun; Park, Byoung Ho

2015-12-01

The objective of this study was to compare the effects of body weight growth adjustment methods on genetic parameters of body growth and tissue among three pig breeds. Data collected on 101,820 Landrace, 281,411 Yorkshire, and 78,068 Duroc pigs, born in Korean swine breeder farms since 2000, were analyzed. Records included body weights on test day and amplitude (A)-mode ultrasound carcass measures of backfat thickness (BF), eye muscle area (EMA), and retail cut percentage (RCP). Days to 90 kg body weight (DAYS90), through an adjustment of the age based on the body weight at the test day, were obtained. Ultrasound measures were also pre-adjusted (ABF, EMA, AEMA, ARCP) based on their test day measures. The (co)variance components were obtained with 3 multi-trait animal models using the REMLF90 software package. Model I included DAYS90 and ultrasound traits, whereas model II and III accounted DAYS90 and pre-adjusted ultrasound traits. Fixed factors were sex (sex) and contemporary groups (herd-year-month of birth) for all traits among the models. Additionally, model I and II considered a linear covariate of final weight on the ultrasound measure traits. Heritability (h(2)) estimates for DAYS90, BF, EMA, and RCP ranged from 0.36 to 0.42, 0.34 to 0.43, 0.20 to 0.22, and 0.39 to 0.45, respectively, among the models. The h(2) estimates of DAYS90 from model II and III were also somewhat similar. The h(2) for ABF, AEMA, and ARCP were 0.35 to 0.44, 0.20 to 0.25, and 0.41 to 0.46, respectively. Our heritability estimates varied mostly among the breeds. The genetic correlations (rG) were moderately negative between DAYS90 and BF (-0.29 to -0.38), and between DAYS90 and EMA (-0.16 to -0.26). BF had strong rG with RCP (-0.87 to -0.93). Moderately positive rG existed between DAYS90 and RCP (0.20 to 0.28) and between EMA and RCP (0.35 to 0.44) among the breeds. For DAYS90, model II and III, its correlations with ABF, AEMA, and ARCP were mostly low or negligible except the rG between DAYS90 and AEMA from model III (0.27 to 0.30). The rG between AEMA and ABF and between AEMA and ARCP were moderate but with negative and positive signs, respectively; also reflected influence of pre-adjustments. However, the rG between BF and RCP remained non-influential to trait pre-adjustments or covariable fits. Therefore, we conclude that ultrasound measures taken at a body weight of about 90 kg as the test final should be adjusted for body weight growth. Our adjustment formulas, particularly those for BF and EMA, should be revised further to accommodate the added variation due to different performance testing endpoints with regard to differential growth in body composition.

Reproductive outcomes after multiagent chemotherapy for high-risk gestational trophoblastic neoplasia.

PubMed

Wong, Jacqueline M K; Liu, Dachao; Lurain, John R

2014-01-01

To analyze the reproductive outcomes of women with high-risk gestational trophoblastic neoplasia (GTN) treated with multiagent EMA-CO chemotherapy. Of 212 patients treated with chemotherapy for GTN between 1986 and 2012, 65 (31%) could be contacted by telephone or mail and consented to participate in a questionnaire designed to assess their menstrual and reproduction outcomes. Twenty-four high-risk (HR) and 41 low-risk (LR) patients consented to the study. Fifteen (63%) HR and 34 (83%) LR women had not undergone hysterectomy (p = 0.08). Of the 12 HR and 33 LR women who could recall their menstrual history, all 12 (100%) HR and 32 (97%) LR women resumed menses after chemotherapy. Both groups also had a similar age of menopause (HR, 43.8 years; LR, 48.5 years) (p = 0.19). Although fewer women in the HR group desired to become pregnant after chemotherapy (HR 5/15 [33%] vs. LR 25/34 [74%]) (p = 0.01), 8 HR women (53%) and 29 LR women (85%) eventually became pregnant (p = 0.03), with equivalent live birth rates of 74% and 76%, respectively. Multiagent EMA-CO chemotherapy did not significantly alter menstrual or reproductive outcomes compared to single-agent methotrexate chemotherapy for GTN.

Paediatric investigation plans for pain: painfully slow!

PubMed

Davies, Elin H; Ollivier, Cecile M; Saint Raymond, Agnes

2010-11-01

To examine the early impact of the Paediatric Regulation, which entered into force in Europe on 27 January 2007, on the development of pharmaceutical drugs in the therapeutic field of pain submitted to the Paediatric Committee (PDCO) and to the European Medicines Agency (EMA). Paediatric Investigations Plans (PIPs) submitted with a Decision (outcome) reached between September 2007 and March 2010 were included in the analysis. Of the 17 Paediatric Investigation Plans submitted, 14 have resulted in an EMA Decision, 3 were withdrawn by the applicants, 8 were granted a full waiver from development, and 1 resulted in a negative opinion. Decisions as issued included 15 clinical trials, with at least 1,282 children to be recruited into studies across five different products. Neonates were included in four of the products. The small number of submissions indicates a lack of new drugs being developed for the management of pain. Ethical concerns that too many vulnerable children will be recruited into clinical trials must be balanced against limiting the number of off-label prescribing and obtaining age-appropriate information on paediatric use. Now is an opportune time for clinicians, academics, learned societies and industry to collaborate for the benefit of children in pain.

Longitudinal social networks impacts on weight and weight-related behaviors assessed using mobile-based ecological momentary assessments: Study Protocols for the SPARC study.

PubMed

Bruening, Meg; Ohri-Vachaspati, Punam; Brewis, Alexandra; Laska, Melissa; Todd, Michael; Hruschka, Daniel; Schaefer, David R; Whisner, Corrie M; Dunton, Genevieve

2016-08-30

The transition from the home to college is a phase in which emerging adults shift toward more unhealthy eating and physical activity patterns, higher body mass indices, thus increasing risk of overweight/obesity. Currently, little is understood about how changing friendship networks shape weight gain behaviors. This paper describes the recruitment, data collection, and data analytic protocols for the SPARC (Social impact of Physical Activity and nutRition in College) study, a longitudinal examination of the mechanisms by which friends and friendship networks influence nutrition and physical activity behaviors and weight gain in the transition to college life. The SPARC study aims to follow 1450 university freshmen from a large university over an academic year, collecting data on multiple aspects of friends and friendship networks. Integrating multiple types of data related to student lives, ecological momentary assessments (EMAs) are administered via a cell phone application, devilSPARC. EMAs collected in four 1-week periods (a total of 4 EMA waves) are integrated with linked data from web-based surveys and anthropometric measurements conducted at four times points (for a total of eight data collection periods including EMAs, separated by ~1 month). University databases will provide student card data, allowing integration of both time-dated data on food purchasing, use of physical activity venues, and geographical information system (GIS) locations of these activities relative to other students in their social networks. Findings are intended to guide the development of more effective interventions to enhance behaviors among college students that protect against weight gain during college.

Developing an Internet- and Mobile-Based System to Measure Cigarette Use Among Pacific Islanders: An Ecological Momentary Assessment Study.

PubMed

Pike, James Russell; Xie, Bin; Tan, Nasya; Sabado-Liwag, Melanie Dee; Orne, Annette; Toilolo, Tupou; Cen, Steven; May, Vanessa; Lee, Cevadne; Pang, Victor Kaiwi; Rainer, Michelle A; Vaivao, Dorothy Etimani S; Lepule, Jonathan Tana; Tanjasiri, Sora Park; Palmer, Paula Healani

2016-01-07

Recent prevalence data indicates that Pacific Islanders living in the United States have disproportionately high smoking rates when compared to the general populace. However, little is known about the factors contributing to tobacco use in this at-risk population. Moreover, few studies have attempted to determine these factors utilizing technology-based assessment techniques. The objective was to develop a customized Internet-based Ecological Momentary Assessment (EMA) system capable of measuring cigarette use among Pacific Islanders in Southern California. This system integrated the ubiquity of text messaging, the ease of use associated with mobile phone apps, the enhanced functionality offered by Internet-based Cell phone-optimized Assessment Techniques (ICAT), and the high survey completion rates exhibited by EMA studies that used electronic diaries. These features were tested in a feasibility study designed to assess whether Pacific Islanders would respond to this method of measurement and whether the data gathered would lead to novel insights regarding the intrapersonal, social, and ecological factors associated with cigarette use. 20 young adult smokers in Southern California who self-identified as Pacific Islanders were recruited by 5 community-based organizations to take part in a 7-day EMA study. Participants selected six consecutive two-hour time blocks per day during which they would be willing to receive a text message linking them to an online survey formatted for Web-enabled mobile phones. Both automated reminders and community coaches were used to facilitate survey completion. 720 surveys were completed from 840 survey time blocks, representing a completion rate of 86%. After adjusting for gender, age, and nicotine dependence, feeling happy (P=<.001) or wanting a cigarette while drinking alcohol (P=<.001) were positively associated with cigarette use. Being at home (P=.02) or being around people who are not smoking (P=.01) were negatively associated with cigarette use. The results of the feasibility study indicate that customized systems can be used to conduct technology-based assessments of tobacco use among Pacific Islanders. Such systems can foster high levels of survey completion and may lead to novel insights for future research and interventions.

Developing an Internet- and Mobile-Based System to Measure Cigarette Use Among Pacific Islanders: An Ecological Momentary Assessment Study

PubMed Central

Tan, Nasya; Sabado-Liwag, Melanie Dee; Orne, Annette; Toilolo, Tupou; Cen, Steven; May, Vanessa; Lee, Cevadne; Pang, Victor Kaiwi; Rainer, Michelle A; Vaivao, Dorothy Etimani S; Lepule, Jonathan Tana; Tanjasiri, Sora Park; Palmer, Paula Healani

2016-01-01

Background Recent prevalence data indicates that Pacific Islanders living in the United States have disproportionately high smoking rates when compared to the general populace. However, little is known about the factors contributing to tobacco use in this at-risk population. Moreover, few studies have attempted to determine these factors utilizing technology-based assessment techniques. Objective The objective was to develop a customized Internet-based Ecological Momentary Assessment (EMA) system capable of measuring cigarette use among Pacific Islanders in Southern California. This system integrated the ubiquity of text messaging, the ease of use associated with mobile phone apps, the enhanced functionality offered by Internet-based Cell phone-optimized Assessment Techniques (ICAT), and the high survey completion rates exhibited by EMA studies that used electronic diaries. These features were tested in a feasibility study designed to assess whether Pacific Islanders would respond to this method of measurement and whether the data gathered would lead to novel insights regarding the intrapersonal, social, and ecological factors associated with cigarette use. Methods 20 young adult smokers in Southern California who self-identified as Pacific Islanders were recruited by 5 community-based organizations to take part in a 7-day EMA study. Participants selected six consecutive two-hour time blocks per day during which they would be willing to receive a text message linking them to an online survey formatted for Web-enabled mobile phones. Both automated reminders and community coaches were used to facilitate survey completion. Results 720 surveys were completed from 840 survey time blocks, representing a completion rate of 86%. After adjusting for gender, age, and nicotine dependence, feeling happy (P=<.001) or wanting a cigarette while drinking alcohol (P=<.001) were positively associated with cigarette use. Being at home (P=.02) or being around people who are not smoking (P=.01) were negatively associated with cigarette use. Conclusions The results of the feasibility study indicate that customized systems can be used to conduct technology-based assessments of tobacco use among Pacific Islanders. Such systems can foster high levels of survey completion and may lead to novel insights for future research and interventions. PMID:26743132

Examining affect and perfectionism in relation to eating disorder symptoms among women with anorexia nervosa.

PubMed

Lavender, Jason M; Mason, Tyler B; Utzinger, Linsey M; Wonderlich, Stephen A; Crosby, Ross D; Engel, Scott G; Mitchell, James E; Le Grange, Daniel; Crow, Scott J; Peterson, Carol B

2016-07-30

This study examined personality and affective variables in relation to eating disorder symptoms in anorexia nervosa (AN). Women (N=118) with DSM-IV AN completed baseline questionnaires (Beck Depression Inventory, Frost Multidimensional Perfectionism Scale) and interviews (Eating Disorder Examination, Yale-Brown-Cornell Eating Disorder Scale), followed by two weeks of ecological momentary assessment (EMA) involving multiple daily reports of affective states and eating disorder behaviors. Hierarchical regression analyses were conducted using eating disorder symptoms as dependent variables (i.e., EMA binge eating, EMA self-induced vomiting, eating disorder rituals, eating disorder preoccupations, dietary restraint). Predictor variables were maladaptive perfectionism (baseline), depressive symptoms (baseline), and affect lability (EMA). Results revealed that affect lability was independently associated with binge eating, whereas depressive symptoms were independently associated with self-induced vomiting. Depressive symptoms were independently associated with eating disorder rituals, whereas both depressive symptoms and maladaptive perfectionism were independently associated with eating disorder preoccupations. Finally, maladaptive perfectionism and affect lability were both independently associated with dietary restraint. This pattern of findings suggests the importance of affective and personality constructs in relation to eating disorder symptoms in AN and may highlight the importance of targeting these variables in the context of treatment. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Revisiting the effective medium approximation in all-dielectric subwavelength multilayers: Breakdown and rebuilding

NASA Astrophysics Data System (ADS)

Lei, Xinrui; Mao, Lei; Lu, Yonghua; Wang, Pei

2017-07-01

Here, we present a comprehensive analysis of the effective medium approximation (EMA) breakdown in all-dielectric deep-subwavelength multilayers made of alternating layers by means of the transfer matrix method. We demonstrated that the approximation is invalid at the vicinity of the effective medium's critical angle for total internal reflection and obtained an analytical criterion for the breakdown of the EMA, which depends on the layer thickness, the incident angle, and the permittivity difference between the alternate layers. We rebuilt the EMA by adding higher-order correction onto the traditional effective permittivity. Furthermore, we found that the EMA breakdown that arises from the boundary effect cannot be repaired in the traditional homogenization strategy with only one layer of effective medium. By adding an artificial matched layer after the conventional effective layer, the boundary effect breakdown was neatly removed.

Basal Cell Carcinoma With Matrical Differentiation: Clinicopathologic, Immunohistochemical, and Molecular Biological Study of 22 Cases.

PubMed

Kyrpychova, Liubov; Carr, Richard A; Martinek, Petr; Vanecek, Tomas; Perret, Raul; Chottová-Dvořáková, Magdalena; Zamecnik, Michal; Hadravsky, Ladislav; Michal, Michal; Kazakov, Dmitry V

2017-06-01

Basal cell carcinoma (BCC) with matrical differentiation is a fairly rare neoplasm, with about 30 cases documented mainly as isolated case reports. We studied a series of this neoplasm, including cases with an atypical matrical component, a hitherto unreported feature. Lesions coded as BCC with matrical differentiation were reviewed; 22 cases were included. Immunohistochemical studies were performed using antibodies against BerEp4, β-catenin, and epithelial membrane antigen (EMA). Molecular genetic studies using Ion AmpliSeq Cancer Hotspot Panel v2 by massively parallel sequencing on Ion Torrent PGM were performed in 2 cases with an atypical matrical component (1 was previously subjected to microdissection to sample the matrical and BCC areas separately). There were 13 male and 9 female patients, ranging in age from 41 to 89 years. Microscopically, all lesions manifested at least 2 components, a BCC area (follicular germinative differentiation) and areas with matrical differentiation. A BCC component dominated in 14 cases, whereas a matrical component dominated in 4 cases. Matrical differentiation was recognized as matrical/supramatrical cells (n=21), shadow cells (n=21), bright red trichohyaline granules (n=18), and blue-gray corneocytes (n=18). In 2 cases, matrical areas manifested cytologic atypia, and a third case exhibited an infiltrative growth pattern, with the tumor metastasizing to a lymph node. BerEP4 labeled the follicular germinative cells, whereas it was markedly reduced or negative in matrical areas. The reverse pattern was seen with β-catenin. EMA was negative in BCC areas but stained a proportion of matrical/supramatrical cells. Genetic studies revealed mutations of the following genes: CTNNB1, KIT, CDKN2A, TP53, SMAD4, ERBB4, and PTCH1, with some differences between the matrical and BCC components. It is concluded that matrical differentiation in BCC in most cases occurs as multiple foci. Rare neoplasms manifest atypia in the matrical areas. Immunohistochemical analysis for BerEP4, EMA, and β-catenin can be helpful in limited biopsy specimens. From a molecular biological prospective, BCC and matrical components appear to share some of the gene mutations but have differences in others, but this observation must be validated in a large series.

Prevalence of coeliac disease in Italian patients affected by Addison's disease.

PubMed

Biagi, Federico; Campanella, Jonia; Soriani, Alessandra; Vailati, Alberto; Corazza, Gino R

2006-03-01

It is well known that coeliac disease is associated with autoimmune endocrine diseases, such as autoimmune thyroid disease and insulin-dependent diabetes mellitus. Recently, coeliac disease has been shown in approximately 10% of patients with autoimmune Addison's disease. Addison's disease is the most common cause of primary adrenocortical insufficiency and it shares several clinical features with coeliac disease. Although hyperpigmentation and hypotension are the most specific signs, gastrointestinal symptoms are common and can be the first complaints of the patients. The aim of our study was to investigate the prevalence of coeliac disease in Italian patients with Addison's disease. Seventeen consecutive patients affected by Addison's disease (14 F, mean age 53.9 years, range 26-79 years) were enrolled in the study. Eleven of them were affected by Addison's disease associated with autoimmune thyroid disease and/or insulin-dependent diabetes mellitus; the other 6 patients were suffering from isolated Addison's disease. Diagnosis had been performed at the age of 40.5 years (range 23-55). Steroid treatment had already been started in 16 of the patients. Endomysial antibodies were tested in all of them and a duodenal biopsy was taken in those found to be positive for antiendomysial antibody (EMA). One out of 17 patients was found to be EMA positive. Duodenal biopsy confirmed the diagnosis of coeliac disease by showing subtotal villous atrophy. Although we studied only a small sample, our preliminary results confirmed that Addison's disease is associated with coeliac disease, being present in 5.9% of patients with Addison's disease. Since the symptoms can be similar and treatment of Addison's disease can mask coeliac disease, this association should always be actively investigated.

How do the EMA and FDA decide which anticancer drugs make it to the market? A comparative qualitative study on decision makers' views.

PubMed

Tafuri, G; Stolk, P; Trotta, F; Putzeist, M; Leufkens, H G; Laing, R O; De Allegri, M

2014-01-01

The process leading to a regulatory outcome is guided by factors both related and unrelated to the data package, defined in this analysis as 'formal and informal factors', respectively. The aim of this qualitative study was to analyse which formal and informal factors drive the decision-making process of the European Medicines Agency (EMA) and Food and Drug Administration (FDA) regulators with regard to anticancer drugs, using in-depth semi-structured interviews with regulators of the two agencies. In line with the theory and practice of qualitative research, no set sample size was defined a priori. Respondent enrolment continued until saturation and redundancy were reached. Data were collected through means of in-depth semi-structured interviews conducted either in a face-to-face setting or via Skype(®) with each regulator. The interviews were audio-recorded and verbatim transcribed. The analysis was manually carried out on the transcribed text. Data were independently coded and categorized by two researchers. Interpretation of the findings emerged through a process of triangulation between the two. Seven EMA and six FDA regulators, who had extensive experience with making decisions about anticancer medicines, were interviewed between April and June 2012. There is an open dialogue between the FDA and EMA, with the two moving closer and exchanging information, not opinions. Differences in decision-making between the agencies may be due to a different evaluation of end points. Different interaction modalities with industry and patients represent an additional source of divergence with a potential impact on decision-making. The key message of our respondents was that the agencies manage uncertainty in a different way: unlike the EMA, the FDA has a prevailing attitude to take risks in order to guarantee quicker access to new treatments. Although formal factors are the main drivers for regulatory decisions, the influence of informal factors plays an important role in the drug evaluation process.

The contributions of the European Medicines Agency and its pediatric committee to the fight against childhood leukemia

PubMed Central

Rose, Klaus; Walson, Philip D

2015-01-01

Background Although the diagnosis of childhood leukemia is no longer a death sentence, too many patients still die, more with acute myeloid leukemia than with acute lymphoblastic leukemia. The European Union pediatric legislation was introduced to improve pharmaceutical treatment of children, but some question whether the European Medicines Agency (EMA) approach is helping children with leukemia. Some have even suggested that the decisions of EMA pediatric committee (PDCO) are counterproductive. This study was designed to investigate the impact of PDCO-issued pediatric investigation plans (PIPs) for leukemia drugs. Methods All PIPs listed under “oncology” were downloaded from the EMA website. Non-leukemia decisions including misclassifications, waivers (no PIP), and solid tumors were discarded. The leukemia decisions were analyzed, compared to pediatric leukemia trials in the database http://www.clinicaltrials.gov, and discussed in the light of current literature. Results The PDCO leukemia decisions demand clinical trials in pediatric leukemia for all new adult drugs without prioritization. However, because leukemia in children is different and much rarer than in adults, these decisions have resulted in proposed studies that are scientifically and ethically questionable. They are also unnecessary, since once promising new compounds are approved for adults, more appropriate, prioritized pediatric leukemia trials are initiated worldwide without PDCO involvement. Conclusion EMA/PDCO leukemia PIPs do little to advance the treatment of childhood leukemia. The unintended negative effects of the flawed EMA/PDCO’s standardized requesting of non-prioritized testing of every new adult leukemia drug in children with relapsed or refractory disease expose these children to questionable trials, and could undermine public trust in pediatric clinical research. Institutions, investigators, and ethics committees/institutional review boards need to be skeptical of trials triggered by PDCO. New, better ways to facilitate drug development for pediatric leukemia are needed. PMID:26604845

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

PubMed

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

2015-10-01

Regulatory review time has been associated with post-market medication safety issues in the United States. Our objective was to evaluate whether regulatory review time and near deadline approval are associated with post-market safety events (PMSEs) for novel medicines approved by the European Medicines Agency (EMA). We performed a cross-sectional analysis of all novel medicines approved by the EMA through the centralized authorization procedure between 2001 and 2010. PMSEs were defined as withdrawals and communications identified through Dear Healthcare Professional Communications (DHPCs). Regulatory review time was defined as the time that elapsed between the start of the assessment procedure and approval. Near regulatory deadline approval was defined as approval within the 30 days before the EMA's 210 day regulatory deadline. Among 161 eligible medicines, PMSEs were identified for 49 (30.4%), 44 of which were DHPCs, five of which were withdrawals. Median regulatory review time was 337 days (IQR 276-406) and was not associated with PMSEs (P = 0.57). However, when categorized by regulatory review speed tertile, there were differences in risk of PMSEs, with higher rates among medicines in the middle tertile (25 of 55, 45.4%; P = 0.01). Finally, 26 medicines were approved near the 210 day regulatory deadline, but were not more likely to have PMSEs (38.5% vs. 28.7%; P = 0.32). Neither faster EMA regulatory review speed nor approval near regulatory deadlines was associated with greater likelihood of PMSEs among recently approved novel medicines. © 2015 The British Pharmacological Society.

Shedding light on food fraud: spectrophotometric and spectroscopic methods as a tool against economically motivated adulteration of food

NASA Astrophysics Data System (ADS)

Petronijević, R. B.; Velebit, B.; Baltić, T.

2017-09-01

Intentional modification of food or substitution of food ingredients with the aim of gaining profit is food fraud or economically motivated adulteration (EMA). EMA appeared in the food supply chain, and following the global expansion of the food market, has become a world-scale problem for the global economy. Food frauds have involved oils, milk and meat products, infant formula, honey, juices, spices, etc. New legislation was enacted in the last decade in order to fight EMA. Effective analytical methods for food fraud detection are few and still in development. The majority of the methods in common use today for EMA detection are time consuming and inappropriate for use on the production line or out of the laboratory. The next step in the evolution of analytical techniques to combat food fraud is development of fast, accurate methods applicable using portable or handheld devices. Spectrophotometric and spectroscopic methods combined with chemometric analysis, and perhaps in combination with other rapid physico-chemical techniques, could be the answer. This review discusses some analytical techniques based on spectrophotometry and spectroscopy, which are used to reveal food fraud and EMA.

Social movements and risk perception: unions, churches, pesticides and bananas in Costa Rica.

PubMed

Barraza, Douglas; Jansen, Kees; van Wendel de Joode, Berna; Wesseling, Catharina

2013-01-01

Between 1992 and 2010 in the Costa Rican Caribbean, a social movement coalition called Foro Emaús sought to change people's view on problems of high pesticide use in banana production. To understand the formation and membership of Foro Emaús, its success period, and its decline. Semi-structured interviews of 28 key actors; a questionnaire survey among school personnel (n = 475) in Siquirres, Matina, and Talamanca counties; and secondary data from newspapers, leaflets, and movement documents were used. Foro Emaús developed activism around pesticide issues and put pressure on governmental agencies and banana companies and shaped people's perception of pesticide risks. The success of the Foro Emaús movement led to the reinforcement of a counteracting social movement (Solidarismo) by conservative sectors of the Catholic Church and the banana companies. We found that the participation of unions in Foro Emaús is an early example of social movement unionism. Scientific pesticide risk analysis is not the only force that shapes emerging societal perceptions of pesticide risk. Social movements influence the priority given to particular risks and can be crucial in putting health and environmental risk issues on the political and research agenda.

Ecological Momentary Assessment and Alcohol Use Disorder Treatment

PubMed Central

Morgenstern, Jon; Kuerbis, Alexis; Muench, Frederick

2014-01-01

The ability to capture real-time data on human behavior inexpensively, efficiently, and accurately holds promise to transform and broaden our understanding of many areas of health science. One approach to acquiring this type of real-time data is ecological momentary assessment (EMA). This method has been used to collect data in many domains of addiction research, including research on the treatment of alcohol use disorders (AUDs). Empirical evidence supports the hypothesis that use of EMA can improve the quality of AUD treatment research when compared with standard assessment methods because it provides more accurate reporting, allows investigators to examine the dynamic unfolding of the behavior change process at an individual level, and can be used to augment and improve clinical assessment and treatment. Overall, the existing literature provides strong support for the advantages of EMA when combined with standard assessment of addictive behaviors in general. Nevertheless, use of EMA in AUD treatment research thus far has been limited, especially in the area of research on mechanisms of behavior change. Existing research indicates, however, that EMA can be used to deliver tailored feedback as a novel and potentially transformative approach to improving AUD treatment. This research area clearly warrants additional future efforts. PMID:26259004

Context-sensitive ecological momentary assessments; integrating real-time exposure measurements, data-analytics and health assessment using a smartphone application.

PubMed

van Wel, Luuk; Huss, Anke; Bachmann, Philipp; Zahner, Marco; Kromhout, Hans; Fröhlich, Jürg; Vermeulen, Roel

2017-06-01

Modern sensor technology makes it possible to collect vast amounts of environmental, behavioural and health data. These data are often linked to contextual information on for example exposure sources which is separately collected with considerable lag time, leading to complications in assessing transient and/or highly spatially variable environmental exposures. Context-Sensitive Ecological Momentary Assessments 1 (CS-EMAs) could be used to address this. We present a case study using radiofrequency-electromagnetic fields (RF-EMF) exposure as an example for implementing CS-EMA in environmental research. Participants were asked to install a custom application on their own smartphone and to wear an RF-EMF exposimeter for 48h. Questionnaires were triggered by the application based on a continuous data stream from the exposimeter. Triggers were divided into four categories: relative and absolute exposure levels, phone calls, and control condition. After the two days of use participants filled in an evaluation questionnaire. 74% of all CS-EMAs were completed, with an average time of 31s to complete a questionnaire once it was opened. Participants reported minimal influence on daily activities. There were no significant differences found between well-being and type of RF-EMF exposure. We show that a CS-EMA based method could be used in environmental research. Using several examples involving environmental stressors, we discuss both current and future applications of this methodology in studying potential health effects of environmental factors. Copyright © 2017 Elsevier Ltd. All rights reserved.

A Report on the Present Status of Engineering Mathematics Test (EMaT)

NASA Astrophysics Data System (ADS)

Watanabe, Toshimasa; Takafuji, Daisuke

The aim of Engineering Mathematics Test (EMaT) is to make sure what essentials in curriculum of Engineering Mathematics is, and to assess university students’ core academic competence and achievement of Engineering Mathematics, helping assurance of students’ academic ability. It is useful for professors to evaluate teaching effect of the classes, and this evaluation would help them improve curricula. Scores can be available for both graduate school entrance examinations and employment tests, leading to selecting persons with basic academic ability in Engineering Mathematics. The scope includes fundamentals in Calculus, Linear Algebra, Differential Equations, and Probability and Statistics. It is open to all students free of charge, and is annually given once in December. In 2007, 2,396 students from 35 universities took EMaT, and the total number of students who have taken EMaT in these 5 years is 6,240.

Case Study: Clinical Governance as an Approach to Improve Maternal and Newborn Health in 22 Hospitals in Indonesia.

PubMed

Amelia, Dwirani; Suhowatsky, Stephanie; Baharuddin, Mohammad; Tholandi, Maya; Hyre, Anne; Sethi, Reena

Clinical governance is a concept used to improve management, accountability and the provision of quality healthcare. An approach to strengthen clinical governance as a means to improve the quality of maternal and newborn care in Indonesia was developed by the Expanding Maternal and Neonatal Survival (EMAS) Program. This case study presents findings and lessons learned from EMAS program experience in 22 hospitals where peer-to-peer mentoring supported staff in strengthening clinical governance from 2012-2015. Efforts resulted in improved hospital preparedness and significantly increased the odds of facility-level coverage for three evidence-based maternal and newborn healthcare interventions.

Clinical trial transparency: an assessment of the disclosure of results of company-sponsored trials associated with new medicines approved recently in Europe.

PubMed

Rawal, Bina; Deane, Bryan R

2014-03-01

Previous studies have raised concerns around the transparency and disclosure rates of clinical trial results on clinical trial registries and in the scientific literature. The objective of this study was to assess the timely disclosure in the public domain of results of company-sponsored clinical trials related to all new medicines approved by the European Medicines Agency (EMA) over a recent 3 year period. The study surveyed various publicly available information sources for both clinical trial registration and disclosure of results (including clinical trial registries, the International Federation of Pharmaceutical Manufacturers and Associations [IFPMA] Clinical Trials Portal, EMA European Public Assessment Reports and PubMed), searched from 27 December 2012 to 31 January 2013. The study covered all 53 new medicines (except vaccines and fixed-dose combinations) approved for marketing by 34 pharmaceutical companies by the EMA in 2009, 2010 and 2011. It included all completed company-sponsored clinical trials conducted in patients and recorded on a clinical trial registry and/or included in an EPAR. OUTCOME MEASURE AND RESULTS: The main outcome measure was the proportion of trials for which results had been disclosed on a registry or in the scientific literature either within 12 months of the later of either first regulatory approval or trial completion, or by 31 January 2013 (end of survey). Of the completed clinical trials associated with all 53 new medicines approved by the EMA between 2009 and 2011, 77% had results disclosed within 12 months. By 31 January 2013, this had increased to 89%. Rates of results disclosure within 12 months were 71%, 81% and 86% for new medicines approved in 2009, 2010 and 2011 respectively. Disclosure increased to 86%, 93% and 91% respectively by 31 January 2013. Although this was a purely quantitative study which did not aim to assess the content of disclosure against any specific requirements, limitations relating to a number of difficulties in finding all relevant data from multiple sources in the public domain were captured. Results of over three-quarters of all company-sponsored clinical trials related to new medicines recently approved by the EMA were disclosed within a year of completion or regulatory approval, and almost 90% were disclosed by 31 January 2013, suggesting transparency is now better than has sometimes been reported previously.

Using Neural Networks in Decision Making for a Reconfigurable Electro Mechanical Actuator (EMA)

NASA Technical Reports Server (NTRS)

Latino, Carl D.

2001-01-01

The objectives of this project were to demonstrate applicability and advantages of a neural network approach for evaluating the performance of an electro-mechanical actuator (EMA). The EMA in question was intended for the X-37 Advanced Technology Vehicle. It will have redundant components for safety and reliability. The neural networks for this application are to monitor the operation of the redundant electronics that control the actuator in real time and decide on the operating configuration. The system we proposed consists of the actuator, sensors, control circuitry and dedicated (embedded) processors. The main purpose of the study was to develop suitable hardware and neural network capable of allowing real time reconfiguration decisions to be made. This approach was to be compared to other methods such as fuzzy logic and knowledge based systems considered for the same application. Over the course of the project a more general objective was the identification of the other neural network applications and the education of interested NASA personnel on the topic of Neural Networks.

Evaluation of the expected moments algorithm and a multiple low-outlier test for flood frequency analysis at streamgaging stations in Arizona

USGS Publications Warehouse

Paretti, Nicholas V.; Kennedy, Jeffrey R.; Cohn, Timothy A.

2014-01-01

Flooding is among the costliest natural disasters in terms of loss of life and property in Arizona, which is why the accurate estimation of flood frequency and magnitude is crucial for proper structural design and accurate floodplain mapping. Current guidelines for flood frequency analysis in the United States are described in Bulletin 17B (B17B), yet since B17B’s publication in 1982 (Interagency Advisory Committee on Water Data, 1982), several improvements have been proposed as updates for future guidelines. Two proposed updates are the Expected Moments Algorithm (EMA) to accommodate historical and censored data, and a generalized multiple Grubbs-Beck (MGB) low-outlier test. The current guidelines use a standard Grubbs-Beck (GB) method to identify low outliers, changing the determination of the moment estimators because B17B uses a conditional probability adjustment to handle low outliers while EMA censors the low outliers. B17B and EMA estimates are identical if no historical information or censored or low outliers are present in the peak-flow data. EMA with MGB (EMA-MGB) test was compared to the standard B17B (B17B-GB) method for flood frequency analysis at 328 streamgaging stations in Arizona. The methods were compared using the relative percent difference (RPD) between annual exceedance probabilities (AEPs), goodness-of-fit assessments, random resampling procedures, and Monte Carlo simulations. The AEPs were calculated and compared using both station skew and weighted skew. Streamgaging stations were classified by U.S. Geological Survey (USGS) National Water Information System (NWIS) qualification codes, used to denote historical and censored peak-flow data, to better understand the effect that nonstandard flood information has on the flood frequency analysis for each method. Streamgaging stations were also grouped according to geographic flood regions and analyzed separately to better understand regional differences caused by physiography and climate. The B17B-GB and EMA-MGB RPD-boxplot results showed that the median RPDs across all streamgaging stations for the 10-, 1-, and 0.2-percent AEPs, computed using station skew, were approximately zero. As the AEP flow estimates decreased (that is, from 10 to 0.2 percent AEP) the variability in the RPDs increased, indicating that the AEP flow estimate was greater for EMA-MGB when compared to B17B-GB. There was only one RPD greater than 100 percent for the 10- and 1-percent AEP estimates, whereas 19 RPDs exceeded 100 percent for the 0.2-percent AEP. At streamgaging stations with low-outlier data, historical peak-flow data, or both, RPDs ranged from −84 to 262 percent for the 0.2-percent AEP flow estimate. When streamgaging stations were separated by the presence of historical peak-flow data (that is, no low outliers or censored peaks) or by low outlier peak-flow data (no historical data), the results showed that RPD variability was greatest for the 0.2-AEP flow estimates, indicating that the treatment of historical and (or) low-outlier data was different between methods and that method differences were most influential when estimating the less probable AEP flows (1, 0.5, and 0.2 percent). When regional skew information was weighted with the station skew, B17B-GB estimates were generally higher than the EMA-MGB estimates for any given AEP. This was related to the different regional skews and mean square error used in the weighting procedure for each flood frequency analysis. The B17B-GB weighted skew analysis used a more positive regional skew determined in USGS Water Supply Paper 2433 (Thomas and others, 1997), while the EMA-MGB analysis used a more negative regional skew with a lower mean square error determined from a Bayesian generalized least squares analysis. Regional groupings of streamgaging stations reflected differences in physiographic and climatic characteristics. Potentially influential low flows (PILFs) were more prevalent in arid regions of the State, and generally AEP flows were larger with EMA-MGB than with B17B-GB for gaging stations with PILFs. In most cases EMA-MGB curves would fit the largest floods more accurately than B17B-GB. In areas of the State with more baseflow, such as along the Mogollon Rim and the White Mountains, streamgaging stations generally had fewer PILFs and more positive skews, causing estimated AEP flows to be larger with B17B-GB than with EMA-MGB. The effect of including regional skew was similar for all regions, and the observed pattern was increasingly greater B17B-GB flows (more negative RPDs) with each decreasing AEP quantile. A variation on a goodness-of-fit test statistic was used to describe each method’s ability to fit the largest floods. The mean absolute percent difference between the measured peak flows and the log-Pearson Type 3 (LP3)-estimated flows, for each method, was averaged over the 90th, 75th, and 50th percentiles of peak-flow data at each site. In most percentile subsets, EMA-MGB on average had smaller differences (1 to 3 percent) between the observed and fitted value, suggesting that the EMA-MGB-LP3 distribution is fitting the observed peak-flow data more precisely than B17B-GB. The smallest EMA-MGB percent differences occurred for the greatest 10 percent (90th percentile) of the peak-flow data. When stations were analyzed by USGS NWIS peak flow qualification code groups, the stations with historical peak flows and no low outliers had average percent differences as high as 11 percent greater for B17B-GB, indicating that EMA-MGB utilized the historical information to fit the largest observed floods more accurately. A resampling procedure was used in which 1,000 random subsamples were drawn, each comprising one-half of the observed data. An LP3 distribution was fit to each subsample using B17B-GB and EMA-MGB methods, and the predicted 1-percent AEP flows were compared to those generated from distributions fit to the entire dataset. With station skew, the two methods were similar in the median percent difference, but with weighted skew EMA-MGB estimates were generally better. At two gages where B17B-GB appeared to perform better, a large number of peak flows were deemed to be PILFs by the MGB test, although they did not appear to depart significantly from the trend of the data (step or dogleg appearance). At two gages where EMA-MGB performed better, the MGB identified several PILFs that were affecting the fitted distribution of the B17B-GB method. Monte Carlo simulations were run for the LP3 distribution using different skews and with different assumptions about the expected number of historical peaks. The primary benefit of running Monte Carlo simulations is that the underlying distribution statistics are known, meaning that the true 1-percent AEP is known. The results showed that EMA-MGB performed as well or better in situations where the LP3 distribution had a zero or positive skew and historical information. When the skew for the LP3 distribution was negative, EMA-MGB performed significantly better than B17B-GB and EMA-MGB estimates were less biased by more closely estimating the true 1-percent AEP for 1, 2, and 10 historical flood scenarios.

Evaluating the utility of administering a reaction time task in an ecological momentary assessment study.

PubMed

Waters, Andrew J; Li, Yisheng

2008-03-01

Cognitive processes underlying drug use have typically been assessed in laboratory settings. More detailed and ecologically valid data may be possible if assessments were conducted in an ecological momentary assessment (EMA) setting. We evaluated the feasibility and utility of administering a reaction time task on a hand-held computer (personal digital assistant, PDA) in an EMA setting. Twenty-two smokers and 22 non-smokers carried around the PDA for 1 week as they went about their daily lives. They were beeped at random times four times per day (random assessments, RAs). Participants were also instructed to press an "anxiety assessment" (AA) button on the PDA whenever they felt suddenly anxious. At each assessment (RA, AA), participants responded to items assessing subjective, pharmacological, and contextual variables, and subsequently completed a Stroop task (classic-Stroop, emotional-Stroop, or smoking-Stroop task). Participants responded to 81.2% of RAs, completed assessments in an average of 4.44 min, reported no interruptions on the majority of assessments (62.4%), and produced data with adequate reliability. Using generalized estimating equation (GEE) analyses, age was associated with the classic-Stroop effect, state anxiety was associated with the emotional-Stroop effect, and Fagerstrom Test for Nicotine Dependence scores were associated with the smoking-Stroop effect. The study provided evidence for the feasibility and utility of the approach.

Performance of two commercial ELISAs for detecting IgA anti-human and anti-guinea pig tissue transglutaminase antibodies.

PubMed

Abrantes-Lemos, Clarice Pires; Nakhle, Maria Cristina; Damiao, Aderson Omar Mourao Cintra; Sipahi, Aytan Miranda; Carrilho, Flair José; Cancado, Eduardo Luiz R

2010-01-01

Sensitivity and specificity of anti-human tissue transglutaminase antibodies (anti-htTGA) seem to be superior to those of anti-tissue transglutaminase of guinea pig (anti-gptTGA) for screening patients with celiac disease (CD), but there are still controversies. The aim of this study was to evaluate the performance of two INOVA ELISA kits to detect IgA anti-htTGA and anti-gptTGA in patients with and without CD. The study groups were comprised of 49 anti-endomysial antibody (EMA)-positive untreated-CD, and 123 controls (EMA-negative treated CD, EMA-negative chronic diarrhea, autoimmune hepatitis, inflammatory bowel disease and healthy people). The agreement between the two ELISAs was statistically significant in all study groups and there was no significant difference between them (92.7% agreement; kappa = 0.70; kappa p = 0.001; McNemar p = 1). All patients with serum reactivity of more than 100 units had histologic diagnosis of CD. In seven of 10 patients with treated-CD who had control biopsies, villous atrophy was still present in four who tested positive by both kits. Two of three celiacs with histologic remission tested positive for both anti-tTGA. the anti-gptTGA and anti-htTGA determination were equally efficient in identifying patients with untreated-CD with high titers of EMA. Whatever the anti-tTGA ELISA used, the reactivity above 100 units was always related to active CD diagnosed by histologic alterations in intestinal biopsies. The anti-tTGA reactivity by both kits was not only similar in determining histologic activity in the follow-up of CD after a gluten free diet, but also in identifying positive sera from the control groups, regardless if CD has been confirmed by duodenal biopsies.

In Vitro Gluten Challenge Test for Celiac Disease Diagnosis.

PubMed

Khalesi, Maryam; Jafari, Seyed Ali; Kiani, Mohammadali; Picarelli, Antonio; Borghini, Raffaele; Sadeghi, Ramin; Eghtedar, Alireza; Ayatollahi, Hosein; Kianifar, Hamid R

2016-02-01

The in vitro gluten challenge test is an important diagnostic modality in celiac disease (CD), especially in patients who begin treatment with a gluten-free diet before adequate diagnostic workup or in cases with atypical CD. Available literature was reviewed regarding the accuracy of the in vitro gluten challenge test for CD diagnosis. MEDLINE, Scopus, and Google Scholar were searched, and studies that used serology and bowel biopsy as the criterion standard for diagnosis were included in our study. Data on authors, publication year, characteristics of the patient and control groups, patients' diet, duration of the gluten challenge test, histology findings, endomysial antibody (EMA) and anti-tissue transglutaminase (tTG) levels, CD markers, and intercellular cell adhesion molecule-1, and human leukocyte antigens before and after the gluten challenge test were extracted. Overall, 15 studies were included in this meta-analysis. Pooled sensitivity %/specificity % was 84/99 for EMA after the challenge, 52/96 for EMA without the challenge, 95.5/98.3 for anti-tTG after the challenge, and 95.1/98.3 for anti-tTG without the challenge test. Sensitivity/specificity for immunological markers were 89/97 for the percentage of CD25⁺-lamina propria lymphocytes, 96/91 for the percentage of CD3⁺-lamina propria lymphocytes, and 96.1/85.7 for the percentage of intercellular cell adhesion molecule-1-lamina propria lymphocytes. The factors that increased the sensitivity of EMA were longer test duration, and the evaluation of patients on a gluten-containing diet or short-term gluten-free diet. The in vitro gluten challenge test can be a useful part of the diagnostic workup of CD, rather than only a model to evaluate its mechanisms.

Middle and High School Students’ Exposure to Alcohol- and Smoking-Related Media: A Pilot Study Using Ecological Momentary Assessment

PubMed Central

Scharf, Deborah M.; Martino, Steven C.; Setodji, Claude M.; Staplefoote, B. Lynette; Shadel, William G.

2013-01-01

The goals of this study were to assess the feasibility of using Ecological Momentary Assessment (EMA) to measure adolescents’ exposure to alcohol and smoking-related media. A sample of 20 middle and high school students completed a two-week EMA protocol in which they monitored exposures to alcohol and smoking-related media. Results showed that adolescents were highly compliant with the study protocol. A total of 255 exposures to alcohol (67%) and smoking (33%) were captured, representing an average of 8.50 (5.82) alcohol-related media exposures and 4.25 (SD = 3.67) smoking-related media exposures and an average of per participant during the study period. Exposures tended to occur in the afternoon (52% alcohol; 54% smoking), at point of sale (44% alcohol; 65% smoking) and on days leading up to the weekend (57% alcohol; 57% smoking). Exposures were also likely in the presence of family (69% alcohol; 56% smoking). Overall, results of this small pilot provide preliminary evidence that EMA is a useful tool for tracking and characterizing middle and high school students’ real-world exposures to alcohol and smoking-related media. Future studies may suggest mechanisms by which media exposures lead to youth uptake of drinking and smoking behaviors. PMID:23772763

The spatial accuracy of geographic ecological momentary assessment (GEMA): Error and bias due to subject and environmental characteristics.

PubMed

Mennis, Jeremy; Mason, Michael; Ambrus, Andreea; Way, Thomas; Henry, Kevin

2017-09-01

Geographic ecological momentary assessment (GEMA) combines ecological momentary assessment (EMA) with global positioning systems (GPS) and geographic information systems (GIS). This study evaluates the spatial accuracy of GEMA location data and bias due to subject and environmental data characteristics. Using data for 72 subjects enrolled in a study of urban adolescent substance use, we compared the GPS-based location of EMA responses in which the subject indicated they were at home to the geocoded home address. We calculated the percentage of EMA locations within a sixteenth, eighth, quarter, and half miles from the home, and the percentage within the same tract and block group as the home. We investigated if the accuracy measures were associated with subject demographics, substance use, and emotional dysregulation, as well as environmental characteristics of the home neighborhood. Half of all subjects had more than 88% of their EMA locations within a half mile, 72% within a quarter mile, 55% within an eighth mile, 50% within a sixteenth of a mile, 83% in the correct tract, and 71% in the correct block group. There were no significant associations with subject or environmental characteristics. Results support the use of GEMA for analyzing subjects' exposures to urban environments. Researchers should be aware of the issue of spatial accuracy inherent in GEMA, and interpret results accordingly. Understanding spatial accuracy is particularly relevant for the development of 'ecological momentary interventions' (EMI), which may depend on accurate location information, though issues of privacy protection remain a concern. Copyright © 2017 Elsevier B.V. All rights reserved.

Quantitative framework for preferential flow initiation and partitioning

USGS Publications Warehouse

Nimmo, John R.

2016-01-01

A model for preferential flow in macropores is based on the short-range spatial distribution of soil matrix infiltrability. It uses elementary areas at two different scales. One is the traditional representative elementary area (REA), which includes a sufficient heterogeneity to typify larger areas, as for measuring field-scale infiltrability. The other, called an elementary matrix area (EMA), is smaller, but large enough to represent the local infiltrability of soil matrix material, between macropores. When water is applied to the land surface, each EMA absorbs water up to the rate of its matrix infiltrability. Excess water flows into a macropore, becoming preferential flow. The land surface then can be represented by a mesoscale (EMA-scale) distribution of matrix infiltrabilities. Total preferential flow at a given depth is the sum of contributions from all EMAs. Applying the model, one case study with multi-year field measurements of both preferential and diffuse fluxes at a specific depth was used to obtain parameter values by inverse calculation. The results quantify the preferential–diffuse partition of flow from individual storms that differed in rainfall amount, intensity, antecedent soil water, and other factors. Another case study provided measured values of matrix infiltrability to estimate parameter values for comparison and illustrative predictions. These examples give a self-consistent picture from the combination of parameter values, directions of sensitivities, and magnitudes of differences caused by different variables. One major practical use of this model is to calculate the dependence of preferential flow on climate-related factors, such as varying soil wetness and rainfall intensity.

Using Intensive Longitudinal Data Collected via Mobile Phone to Detect Imminent Lapse in Smokers Undergoing a Scheduled Quit Attempt.

PubMed

Businelle, Michael S; Ma, Ping; Kendzor, Darla E; Frank, Summer G; Wetter, David W; Vidrine, Damon J

2016-10-17

Mobile phone‒based real-time ecological momentary assessments (EMAs) have been used to record health risk behaviors, and antecedents to those behaviors, as they occur in near real time. The objective of this study was to determine if intensive longitudinal data, collected via mobile phone, could be used to identify imminent risk for smoking lapse among socioeconomically disadvantaged smokers seeking smoking cessation treatment. Participants were recruited into a randomized controlled smoking cessation trial at an urban safety-net hospital tobacco cessation clinic. All participants completed in-person EMAs on mobile phones provided by the study. The presence of six commonly cited lapse risk variables (ie, urge to smoke, stress, recent alcohol consumption, interaction with someone smoking, cessation motivation, and cigarette availability) collected during 2152 prompted or self-initiated postcessation EMAs was examined to determine whether the number of lapse risk factors was greater when lapse was imminent (ie, within 4 hours) than when lapse was not imminent. Various strategies were used to weight variables in efforts to improve the predictive utility of the lapse risk estimator. Participants (N=92) were mostly female (52/92, 57%), minority (65/92, 71%), 51.9 (SD 7.4) years old, and smoked 18.0 (SD 8.5) cigarettes per day. EMA data indicated significantly higher urges (P=.01), stress (P=.002), alcohol consumption (P<.001), interaction with someone smoking (P<.001), and lower cessation motivation (P=.03) within 4 hours of the first lapse compared with EMAs collected when lapse was not imminent. Further, the total number of lapse risk factors present within 4 hours of lapse (mean 2.43, SD 1.37) was significantly higher than the number of lapse risk factors present during periods when lapse was not imminent (mean 1.35, SD 1.04), P<.001. Overall, 62% (32/52) of all participants who lapsed completed at least one EMA wherein they reported ≥3 lapse risk factors within 4 hours of their first lapse. Differentially weighting lapse risk variables resulted in an improved risk estimator (weighted area=0.76 vs unweighted area=0.72, P<.004). Specifically, 80% (42/52) of all participants who lapsed had at least one EMA with a lapse risk score above the cut-off within 4 hours of their first lapse. Real-time estimation of smoking lapse risk is feasible and may pave the way for development of mobile phone‒based smoking cessation treatments that automatically tailor treatment content in real time based on presence of specific lapse triggers. Interventions that identify risk for lapse and automatically deliver tailored messages or other treatment components in real time could offer effective, low cost, and highly disseminable treatments to individuals who do not have access to other more standard cessation treatments.

Primordial germ cells in the dorsal mesentery of the chicken embryo demonstrate left-right asymmetry and polarized distribution of the EMA1 epitope.

PubMed

Hen, Gideon; Friedman-Einat, Miriam; Sela-Donenfeld, Dalit

2014-05-01

Despite the importance of the chicken as a model system, our understanding of the development of chicken primordial germ cells (PGCs) is far from complete. Here we characterized the morphology of PGCs at different developmental stages, their migration pattern in the dorsal mesentery of the chicken embryo, and the distribution of the EMA1 epitope on PGCs. The spatial distribution of PGCs during their migration was characterized by immunofluorescence on whole-mounted chicken embryos and on paraffin sections, using EMA1 and chicken vasa homolog antibodies. While in the germinal crescent PGCs were rounded and only 25% of them were labeled by EMA1, often seen as a concentrated cluster on the cell surface, following extravasation and migration in the dorsal mesentery PGCs acquired an elongated morphology, and 90% exhibited EMA1 epitope, which was concentrated at the tip of the pseudopodia, at the contact sites between neighboring PGCs. Examination of PGC migration in the dorsal mesentery of Hamburger and Hamilton stage 20-22 embryos demonstrated a left-right asymmetry, as migration of cells toward the genital ridges was usually restricted to the right, rather than the left, side of the mesentery. Moreover, an examination of another group of cells that migrate through the dorsal mesentery, the enteric neural crest cells, revealed a similar preference for the right side of the mesentery, suggesting that the migratory pathway of PGCs is dictated by the mesentery itself. Our findings provide new insights into the migration pathway of PGCs in the dorsal mesentery, and suggest a link between EMA1, PGC migration and cell-cell interactions. These findings may contribute to a better understanding of the mechanism underlying migration of PGCs in avians. © 2014 Anatomical Society.

Muscle mechanical advantage of human walking and running: implications for energy cost.

PubMed

Biewener, Andrew A; Farley, Claire T; Roberts, Thomas J; Temaner, Marco

2004-12-01

Muscular forces generated during locomotion depend on an animal's speed, gait, and size and underlie the energy demand to power locomotion. Changes in limb posture affect muscle forces by altering the mechanical advantage of the ground reaction force (R) and therefore the effective mechanical advantage (EMA = r/R, where r is the muscle mechanical advantage) for muscle force production. We used inverse dynamics based on force plate and kinematic recordings of humans as they walked and ran at steady speeds to examine how changes in muscle EMA affect muscle force-generating requirements at these gaits. We found a 68% decrease in knee extensor EMA when humans changed gait from a walk to a run compared with an 18% increase in hip extensor EMA and a 23% increase in ankle extensor EMA. Whereas the knee joint was extended (154-176 degrees) during much of the support phase of walking, its flexed position (134-164 degrees) during running resulted in a 5.2-fold increase in quadriceps impulse (time-integrated force during stance) needed to support body weight on the ground. This increase was associated with a 4.9-fold increase in the ground reaction force moment about the knee. In contrast, extensor impulse decreased 37% (P < 0.05) at the hip and did not change at the ankle when subjects switched from a walk to a run. We conclude that the decrease in limb mechanical advantage (mean limb extensor EMA) and increase in knee extensor impulse during running likely contribute to the higher metabolic cost of transport in running than in walking. The low mechanical advantage in running humans may also explain previous observations of a greater metabolic cost of transport for running humans compared with trotting and galloping quadrupeds of similar size.

A Text Message Intervention with Adaptive Goal Support to Reduce Alcohol Consumption Among Non-Treatment-Seeking Young Adults: Non-Randomized Clinical Trial with Voluntary Length of Enrollment.

PubMed

Suffoletto, Brian; Chung, Tammy; Muench, Frederick; Monti, Peter; Clark, Duncan B

2018-02-16

Stand-alone text message-based interventions can reduce binge drinking episodes (≥4 drinks for women and ≥5 drinks for men) among nontreatment-seeking young adults, but may not be optimized. Adaptive text message support could enhance effectiveness by assisting context-specific goal setting and striving, but it remains unknown how to best integrate it into text message interventions. The objective of this study was to evaluate young adults' engagement with a text message intervention, Texting to Reduce Alcohol Consumption 2 (TRAC2), which focuses on reducing weekend alcohol consumption. TRAC2 incorporated preweekend drinking-limit goal-commitment ecological momentary assessments (EMA) tailored to past 2-week alcohol consumption, intraweekend goal reminders, self-efficacy EMA with support tailored to goal confidence, and maximum weekend alcohol consumption EMA with drinking limit goal feedback. We enrolled 38 nontreatment-seeking young adults (aged 18 to 25 years) who screened positive for hazardous drinking in an urban emergency department. Following a 2-week text message assessment-only run-in, subjects were given the opportunity to enroll in 4-week intervention blocks. We examined patterns of EMA responses and voluntary re-enrollment. We then examined how goal commitment and goal self-efficacy related to event-level alcohol consumption. Finally, we examined the association of length of TRAC2 exposure with alcohol-related outcomes from baseline to 3-month follow-up. Among a diverse sample of young adults (56% [28/50] female, 54% [27/50] black, 32% [12/50] college enrolled), response rates to EMA queries were, on average, 82% for the first 4-week intervention block, 75% for the second 4-week block, and 73% for the third 4-week block. In the first 4 weeks of the intervention, drinking limit goal commitment was made 68/71 times it was prompted (96%). The percentage of subjects being prompted to commit to a drinking limit goal above the binge threshold was 52% (15/29) in week 1 and decreased to 0% (0/15) by week 4. Subjects met their goal 130/146 of the times a goal was committed to (89.0%). There were lower rates of goal success when subjects reported lower confidence (score <4) in meeting the goal (76% [32/42 weekends]) compared with that when subjects reported high confidence (98% [56/57 weekends]; P=.001). There were reductions in alcohol consumption from baseline to 3 months, but reductions were not different by length of intervention exposure. Preliminary evidence suggests that nontreatment-seeking young adults will engage with a text message intervention incorporating self-regulation support features, resulting in high rates of weekend drinking limit goal commitment and goal success. ©Brian Suffoletto, Tammy Chung, Frederick Muench, Peter Monti, Duncan B Clark. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 16.02.2018.

A Rhizavidin Monomer with Nearly Multimeric Avidin-Like Binding Stability Against Biotin Conjugates.

PubMed

Lee, Jeong Min; Kim, Jung A; Yen, Tzu-Chi; Lee, In Hwan; Ahn, Byungjun; Lee, Younghoon; Hsieh, Chia-Lung; Kim, Ho Min; Jung, Yongwon

2016-03-01

Developing a monomeric form of an avidin-like protein with highly stable biotin binding properties has been a major challenge in biotin-avidin linking technology. Here we report a monomeric avidin-like protein-enhanced monoavidin-with off-rates almost comparable to those of multimeric avidin proteins against various biotin conjugates. Enhanced monoavidin (eMA) was developed from naturally dimeric rhizavidin by optimally maintaining protein rigidity during monomerization and additionally shielding the bound biotin by diverse engineering of the surface residues. eMA allowed the monovalent and nonperturbing labeling of head-group-biotinylated lipids in bilayer membranes. In addition, we fabricated an unprecedented 24-meric avidin probe by fusing eMA to a multimeric cage protein. The 24-meric avidin and eMA were utilized to demonstrate how artificial clustering of cell-surface proteins greatly enhances the internalization rates of assembled proteins on live cells. © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Wireless Sensor-Dependent Ecological Momentary Assessment for Pediatric Asthma mHealth Applications

PubMed Central

Buonocore, Chris M.; Rocchio, Rosemary A.; Roman, Alfonso; King, Christine E.; Sarrafzadeh, Majid

2018-01-01

Pediatric asthma is a prevalent chronic disease condition that can benefit from wireless health systems through constant symptom management. In this paper, we propose a smart watch based wireless health system that incorporates wireless sensing and ecological momentary assessment (EMA) to determine an individual’s asthma symptoms. Since asthma is a multifaceted disease, this approach provides individualized symptom assessments through various physiological and environmental wireless sensor based EMA triggers specific to common asthma exacerbations. Furthermore, the approach described here improves compliance to use of the system through insightful EMA scheduling related to sensor detected environmental and physiological changes, as well as the patient’s own schedule. After testing under several real world conditions, it was found that the system is sensitive to both physiological and environmental conditions that would cause asthma symptoms. Furthermore, the EMA questionnaires that were triggered based on these changes were specific to the asthma trigger itself, allowing for invaluable context behind the data to be collected. PMID:29445779

Wireless Sensor-Dependent Ecological Momentary Assessment for Pediatric Asthma mHealth Applications.

PubMed

Buonocore, Chris M; Rocchio, Rosemary A; Roman, Alfonso; King, Christine E; Sarrafzadeh, Majid

2017-07-01

Pediatric asthma is a prevalent chronic disease condition that can benefit from wireless health systems through constant symptom management. In this paper, we propose a smart watch based wireless health system that incorporates wireless sensing and ecological momentary assessment (EMA) to determine an individual's asthma symptoms. Since asthma is a multifaceted disease, this approach provides individualized symptom assessments through various physiological and environmental wireless sensor based EMA triggers specific to common asthma exacerbations. Furthermore, the approach described here improves compliance to use of the system through insightful EMA scheduling related to sensor detected environmental and physiological changes, as well as the patient's own schedule. After testing under several real world conditions, it was found that the system is sensitive to both physiological and environmental conditions that would cause asthma symptoms. Furthermore, the EMA questionnaires that were triggered based on these changes were specific to the asthma trigger itself, allowing for invaluable context behind the data to be collected.

Ecological Momentary Assessment of Pain, Fatigue, Depressive, and Cognitive Symptoms Reveals Significant Daily Variability in Multiple Sclerosis.

PubMed

Kratz, Anna L; Murphy, Susan L; Braley, Tiffany J

2017-11-01

To describe the daily variability and patterns of pain, fatigue, depressed mood, and cognitive function in persons with multiple sclerosis (MS). Repeated-measures observational study of 7 consecutive days of home monitoring, including ecological momentary assessment (EMA) of symptoms. Multilevel mixed models were used to analyze data. General community. Ambulatory adults (N=107) with MS recruited through the University of Michigan and surrounding community. Not applicable. EMA measures of pain, fatigue, depressed mood, and cognitive function rated on a 0 to 10 scale, collected 5 times a day for 7 days. Cognitive function and depressed mood exhibited more stable within-person patterns than pain and fatigue, which varied considerably within person. All symptoms increased in intensity across the day (all P<.02), with fatigue showing the most substantial increase. Notably, this diurnal increase varied by sex and age; women showed a continuous increase from wake to bedtime, whereas fatigue plateaued after 7 pm for men (wake-bed B=1.04, P=.004). For the oldest subgroup, diurnal increases were concentrated to the middle of the day compared with younger subgroups, which showed an earlier onset of fatigue increase and sustained increases until bed time (wake-3 pm B=.04, P=.01; wake-7 pm B=.03, P=.02). Diurnal patterns of cognitive function varied by education; those with advanced college degrees showed a more stable pattern across the day, with significant differences compared with those with bachelor-level degrees in the evening (wake-7 pm B=-.47, P=.02; wake-bed B=-.45, P=.04). Findings suggest that chronic symptoms in MS are not static, even over a short time frame; rather, symptoms-fatigue and pain in particular-vary dynamically across and within days. Incorporation of EMA methods should be considered in the assessment of these chronic MS symptoms to enhance assessment and treatment strategies. Copyright © 2017 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

A life-time of stuttering: how emotional reactions to stuttering impact activities and participation in older people.

PubMed

Bricker-Katz, Geraldine; Lincoln, Michelle; McCabe, Patricia

2009-01-01

The International Classification of Functioning, Disability and Health (ICF) framework has a pragmatic focus on how impairment impacts the individual's activities and participation. Stuttering is known to impact communication in younger adults but this has not been established in older people who stutter. In this study, emotional reactions to stuttering were investigated in a group 55 years and older who self-reported stuttering since childhood. This was a cross-sectional descriptive design. Twelve participants who self-reported that they still stuttered and in whom stuttering was confirmed, and 14 controls completed the Fear of Negative Evaluation Scale (FNES), The Endler Multi-dimensional Anxiety Scales-Trait (EMAS-T) and The Australian Personal Wellbeing Index (PWA-I). Participants whose stuttering persisted also completed the Overall Assessment of Speakers Experience of Stuttering (OASES). The group who stuttered scored significantly higher on the FNES, with scores in the social phobia range. Responses on the OASES showed that stuttering continues to be a negative experience for this older group. Results for the EMAS-T and PWA-I were within the average range across both participant groups however significant differences existed between the groups in the social evaluative and physical danger domains of the EMAS-T, and the satisfaction with health domain of the PWA-I. Significant fear of negative evaluation, which is the key feature for social anxiety, was found in the group of older people who stuttered with a higher level of trait anxiety in social evaluative domains. The OASES showed that they also reacted to stuttering and communication in daily situations with moderate to severe impact scores which showed that stuttering impacted on speaking activities and by those negative experiences limited communication. Limited communication and restricted participation in the lives of older people have implications for healthy productive ageing and this is discussed.

Omitting duodenal biopsy in children with suspected celiac disease and extra-intestinal symptoms.

PubMed

Bozzola, Mauro; Meazza, Cristina; Gertosio, Chiara; Pagani, Sara; Larizza, Daniela; Calcaterra, Valeria; Luinetti, Ombretta; Farello, Giovanni; Tinelli, Carmine; Iughetti, Lorenzo

2017-07-15

The aim of our study is to evaluate if in children with highly positive serology and HLA-DQ2/DQ8 (triple test, TT) and only extra-intestinal symptoms, it is possible to omit performing an intestinal biopsy for celiac disease (CD) diagnosis, as suggested by the new European Society for Pediatric Gastroenterology, Hepatology and Nutrition ESPGHAN guidelines. In this retrospective study a total of 105 patients, suspected of having CD because of extra-intestinal symptoms and showing serum tissue transglutaminase antibody (anti-tTG) and anti-endomysial antibody (EMA) measurements and HLA genotyping, were considered for the final analysis (33 boys and 72 girls; age range 1.5-17.6 years). Histological findings confirmed diagnosis of CD in 97 (92.4%) patients. Forty-one patients (39%) showed anti-tTG >10 times normal values, positive EMA and positive HLA-DQ2/DQ8 (positive TT). All of them had a diagnosis of CD, therefore there were no false positive cases. Sixty-four patients were negative for the TT. In eight cases, CD was ruled out and these were considered true negative cases. In the remaining 56 negative TT patients, intestinal biopsy confirmed CD diagnosis and they were considered false negatives. Based on these results, specificity for the TT was 100% and sensitivity was 42.3%. On the basis of the present study, diagnosis of CD can be reliably performed without a duodenal biopsy in children with only extra-intestinal symptoms.

Effectiveness of a hospital school mathematics literacy program.

PubMed

Covic, Amalia Neide; Kanemoto, Eduardo; Bastos, Andre Covic

2012-01-01

To receive treatment for cancer, patients in Brazil often travel to larger hospitals that may be located far away from their families and communities. Pediatric patients miss time in the classroom and may achieve educational milestones later than other students. They may also struggle with some educational topics after receiving certain types of cancer treatment. The Hospital School at the GRAACC helps to close this education gap by providing educational support to school-age students receiving treatment for cancer. In addition to providing educational services during treatment, teachers at the hospital school, Mobile School - Specific Student (EMAE). The objective of this preliminary study is to build knowledge about the impact of school enrollment on mathematics literacy in hospitalized cancer patients undergoing treatment. We followed 15-year-old patients (n = 54) with at last 1 year inside the hospital school for a period of 8 years (2001-2008). Study participants were affected by a variety of diseases including bone tumors (n = 39), Hodgkin lymphoma (n = 08) and non-Hodgkin lymphoma (n = 07). The level of participants' mathematical literacy was regularly assessed by reviewing the results of formative assessments completed by students. Using that information, students were grouped into categories according to mathematics literacy levels established by the Programme for International Student Assessment (PISA). The formative assessment is based on the analysis of all the material produced by the student and the EMAE teacher across the years of the study, including the recordings of working meetings that were held with all the teachers every class day.

Safety of Electromagnetic Articulography in Patients with Pacemakers and Implantable Cardioverter-Defibrillators

ERIC Educational Resources Information Center

Joglar, Jose A.; Nguyen, Carol; Garst, Diane M.; Katz, William F.

2009-01-01

Purpose: "Electromagnetic articulography (EMA)" uses a helmet to create alternating magnetic fields for tracking speech articulator movement. An important safety consideration is whether EMA magnetic fields interfere with the operation of speakers' pacemakers or implantable cardioverter-defibrillators (ICDs). In this investigation,…

Applicability of the Effective-Medium Approximation to Heterogeneous Aerosol Particles.

NASA Technical Reports Server (NTRS)

Mishchenko, Michael I.; Dlugach, Janna M.; Liu, Li

2016-01-01

The effective-medium approximation (EMA) is based on the assumption that a heterogeneous particle can have a homogeneous counterpart possessing similar scattering and absorption properties. We analyze the numerical accuracy of the EMA by comparing superposition T-matrix computations for spherical aerosol particles filled with numerous randomly distributed small inclusions and Lorenz-Mie computations based on the Maxwell-Garnett mixing rule. We verify numerically that the EMA can indeed be realized for inclusion size parameters smaller than a threshold value. The threshold size parameter depends on the refractive-index contrast between the host and inclusion materials and quite often does not exceed several tenths, especially in calculations of the scattering matrix and the absorption cross section. As the inclusion size parameter approaches the threshold value, the scattering-matrix errors of the EMA start to grow with increasing the host size parameter and or the number of inclusions. We confirm, in particular, the existence of the effective-medium regime in the important case of dust aerosols with hematite or air-bubble inclusions, but then the large refractive-index contrast necessitates inclusion size parameters of the order of a few tenths. Irrespective of the highly restricted conditions of applicability of the EMA, our results provide further evidence that the effective-medium regime must be a direct corollary of the macroscopic Maxwell equations under specific assumptions.

The development of an indoor mobility course for the evaluation of electronic mobility aids for persons who are visually impaired.

PubMed

Roentgen, Uta R; Gelderblom, Gert Jan; de Witte, Luc P

2012-01-01

To develop a suitable mobility course for the assessment of mobility performance as part of a user evaluation of Electronic Mobility Aids (EMA) aimed at obstacle detection and orientation. A review of the literature led to a list of critical factors for the assessment of mobility performance of persons who are visually impaired. Based upon that list, method, test situations, and determining elements were selected and presented to Dutch orientation and mobility experts. Due to expert advice and a pilot study, minor changes were made and the final version was used for the evaluation of two EMA by eight persons who are visually impaired. The results of the literature study are summarized in an overview of critical factors for the assessment of the mobility performance of persons who are visually impaired. Applied to the requirements of the above mentioned user evaluation a replicable indoor mobility course has been described in detail and tested. Based upon evidence from literature an indoor mobility course has been developed, which was sensitive to assess differences in mobility incidents and obstacle detection when using an EMA compared to the regular mobility aid. Experts' opinion confirmed its face and content validity.

Metabolic pathway analysis and kinetic studies for production of nattokinase in Bacillus subtilis.

PubMed

Unrean, Pornkamol; Nguyen, Nhung H A

2013-01-01

We have constructed a reaction network model of Bacillus subtilis. The model was analyzed using a pathway analysis tool called elementary mode analysis (EMA). The analysis tool was used to study the network capabilities and the possible effects of altered culturing conditions on the production of a fibrinolytic enzyme, nattokinase (NK) by B. subtilis. Based on all existing metabolic pathways, the maximum theoretical yield for NK synthesis in B. subtilis under different substrates and oxygen availability was predicted and the optimal culturing condition for NK production was identified. To confirm model predictions, experiments were conducted by testing these culture conditions for their influence on NK activity. The optimal culturing conditions were then applied to batch fermentation, resulting in high NK activity. The EMA approach was also applied for engineering B. subtilis metabolism towards the most efficient pathway for NK synthesis by identifying target genes for deletion and overexpression that enable the cell to produce NK at the maximum theoretical yield. The consistency between experiments and model predictions proves the feasibility of EMA being used to rationally design culture conditions and genetic manipulations for the efficient production of desired products.

Volumetric dimensional changes of dental light-cured dimethacrylate resins after sorption of water or ethanol.

PubMed

Sideridou, Irini D; Karabela, Maria M; Vouvoudi, Evagelia Ch

2008-08-01

This study evaluated the influence of water and ethanol sorption on the volumetric dimensional changes of resins prepared by light curing of Bis-GMA, Bis-EMA, UDMA, TEGDMA or D(3)MA. The resin specimens (15mm diameterx1mm height) were immersed in water or ethanol 37+/-1 degrees C for 30 days. Volumetric changes of specimens were obtained via accurate mass measurements using Archimedes principle. The specimens were reconditioned by dry storage in an oven at 37+/-1 degrees C until constant mass was obtained and then immersed in water or ethanol for 30 days. The volumetric changes of specimens were determined and compared to those obtained from the first sorption. Resins showed similar volume increase during the first and second sorptions of water or ethanol. The volume increase due to water absorption is in the following order: poly-TEGDMA>poly-Bis-GMA>poly-UDMA>poly-Bis-EMA>poly-D(3)MA. On the contrary, the order in ethanol is poly-Bis-GMA>poly-UDMA>poly-TEGDMA>poly-Bis-EMA approximately poly-D(3)MA. The volume increase was found to depend linearly on the amount of water or ethanol absorbed. In the choice of monomers for preparation of composite resin matrix the volume increase in the resin after immersion in water or ethanol must be taken into account. Resins of Bis-EMA and D(3)MA showed the lowest values.

Identification and Quantitation of Malonic Acid Biomarkers of In-Born Error Metabolism by Targeted Metabolomics

NASA Astrophysics Data System (ADS)

Ambati, Chandra Shekar R.; Yuan, Furong; Abu-Elheiga, Lutfi A.; Zhang, Yiqing; Shetty, Vivekananda

2017-05-01

Malonic acid (MA), methylmalonic acid (MMA), and ethylmalonic acid (EMA) metabolites are implicated in various non-cancer disorders that are associated with inborn-error metabolism. In this study, we have slightly modified the published 3-nitrophenylhydrazine (3NPH) derivatization method and applied it to derivatize MA, MMA, and EMA to their hydrazone derivatives, which were amenable for liquid chromatography- mass spectrometry (LC-MS) quantitation. 3NPH was used to derivatize MA, MMA, and EMA, and multiple reaction monitoring (MRM) transitions of the corresponding derivatives were determined by product-ion experiments. Data normalization and absolute quantitation were achieved by using 3NPH derivatized isotopic labeled compounds 13C2-MA, MMA-D3, and EMA-D3. The detection limits were found to be at nanomolar concentrations and a good linearity was achieved from nanomolar to millimolar concentrations. As a proof of concept study, we have investigated the levels of malonic acids in mouse plasma with malonyl-CoA decarboxylase deficiency (MCD-D), and we have successfully applied 3NPH method to identify and quantitate all three malonic acids in wild type (WT) and MCD-D plasma with high accuracy. The results of this method were compared with that of underivatized malonic acid standards experiments that were performed using hydrophilic interaction liquid chromatography (HILIC)-MRM. Compared with HILIC method, 3NPH derivatization strategy was found to be very efficient to identify these molecules as it greatly improved the sensitivity, quantitation accuracy, as well as peak shape and resolution. Furthermore, there was no matrix effect in LC-MS analysis and the derivatized metabolites were found to be very stable for longer time.

Development of Electrochemical Supercapacitors for EMA Applications

NASA Technical Reports Server (NTRS)

Kosek, John A.; Dunning, Thomas; LaConti, Anthony B.

1996-01-01

A limitation of the typical electrochemical capacitor is the maximum available power and energy density, and an improvement in capacitance per unit weight and volume is needed. A solid-ionomer electrochemical capacitor having a unit cell capacitance greater than 2 F/sq cm and a repeating element thickness of 6 mils has been developed. This capacitor could provide high-current pulses for electromechanical actuation (EMA). Primary project objectives were to develop high-capacitance particulates, to increase capacitor gravimetric and volumetric energy densities above baseline and to fabricate a 10-V capacitor with a repeating element thickness of 6 mils or less. Specific EMA applications were identified and capacitor weight and volume projections made.

Mobile Phone Ecological Momentary Assessment of Daily Stressors Among People Living With HIV: Elucidating Factors Underlying Health-Related Challenges in Daily Routines.

PubMed

Farmer, Shu; Mindry, Deborah; Comulada, W Scott; Swendeman, Dallas

Stressful life events and daily hassles affect people living with HIV (PLWH). However, capturing stress-related events and cognitive impairment is often plagued with recall biases. Incorporating reliable information technology, such as mobile phones, can be a resourceful method for measuring health behaviors (MHB). We report findings from an MHB pilot study with 32 African American, Latino/Hispanic, and White PLWH from Los Angeles. Participants reported perceived stressors in their daily routines using a smartphone Ecological Momentary Assessment (EMA) application. Participants self-initiated in-the-moment stressful events reports for up to 6 weeks. Stressful event EMAs queried perceived stress levels (1-10 scale) and open-ended text descriptions. Qualitative analysis of participant text responses was completed using grounded thematic coding. Participants reported multiple stressors in their daily routines, impacting activities of daily living or daily functioning. Eliciting input from PLWH via EMA in real time is a novel approach for assessing and identifying sources of stress. Copyright © 2017 Association of Nurses in AIDS Care. Published by Elsevier Inc. All rights reserved.

Supportive intervention using a mobile phone in behavior modification.

PubMed

Hareva, David H; Okada, Hiroki; Kitawaki, Tomoki; Oka, Hisao

2009-04-01

The authors previously developed a mobile ecological momentary assessment (EMA) system as a real-time data collection device using a mobile phone. In this study, a real-time advice function and real-time reporting function were added to the previous system as a supportive intervention. The improved system was found to work effectively and was applied to several clinical cases, including patients with depressive disorder, dizziness, smoking habit, and bronchial asthma. The average patient compliance rate was high (89%) without the real-time advice and higher (93%) with the advice. The trends in clinical data for patients using a mobile EMA with/without the new function were analyzed for up to several months. In the case of dizziness, an improving trend in its clinical data was observed after applying the real-time advice, and in the case of depressive disorder, a stabilizing trend was observed. The mobile EMA system with the real-time advice function could be useful as a supportive intervention in behavior modification and for motivating patients in self-management of their disease.

Within-person associations between daily motivation and self-efficacy and drinking among problem drinkers in treatment.

PubMed

Morgenstern, Jon; Kuerbis, Alexis; Houser, Jessica; Muench, Frederick J; Shao, Sijing; Treloar, Hayley

2016-09-01

Gaining a better understanding of the change process holds promise to improve alcohol treatment. Ecological momentary assessment (EMA) coupled with intensive longitudinal data (ILD) approaches have been proposed as promising methods that can advance change process research but have been used infrequently in alcohol use disorder (AUD) treatment research. The current study used these approaches to examine the within-person associations of motivation and self-efficacy and drinking among treatment-seeking problem drinkers. Participants (N = 96) received daily EMA surveys before, during, and after treatment for 7 weeks spread over a 9-month period. Multilevel modeling was used to test the within-person relationships between the change processes and drinking, controlling for between-person associations and prior drinking. Results indicated that daily fluctuations in motivation and self-efficacy significantly predicted drinking over the next 24 hours; however, several theory-driven hypotheses regarding factors that might moderate that relationship were not supported. Overall, results support the advantages of EMA and ILD as methods that can advance AUD treatment research. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Economic valuation of the Emas waterfall, Mogi-Guaçu River, SP, Brazil.

PubMed

Peixer, Janice; Giacomini, Henrique C; Petrere, Miguel

2011-12-01

The Emas waterfall in Mogi-Guaçu River is regionally recognized as an important fishing spot and touristic place. The first reports of the professional and sport fishing there date back from the 30's, which is the same period when the tourism took place. The present paper provides an environmental valuation of this place and an assessment of the differences among the major groups of people using the area. During 2006 we interviewed 33 professional fishers, 107 sport fishers, 45 tourists and 103 excursionists in order to estimate the Willingness to Pay (WTP) for each category and to analyze the influence of socioeconomic factors by means of logistic regressions and ANCOVAs. The WTP of professional fisher was significantly influenced by age and education, and the WTP for the sport fishers was influenced by the family income. The variables that influenced the tourists' and excursionists' WTP were sex and education. The total annual aggregated value to maintain the waterfall in the current conditions was estimated in US$ 11.432.128, and US$ 55.424.283 to restore it.

Overview of Serological Techniques for Influenza Vaccine Evaluation: Past, Present and Future

PubMed Central

Trombetta, Claudia Maria; Perini, Daniele; Mather, Stuart; Temperton, Nigel; Montomoli, Emanuele

2014-01-01

Serological techniques commonly used to quantify influenza-specific antibodies include the Haemagglutination Inhibition (HI), Single Radial Haemolysis (SRH) and Virus Neutralization (VN) assays. HI and SRH are established and reproducible techniques, whereas VN is more demanding. Every new influenza vaccine needs to fulfil the strict criteria issued by the European Medicines Agency (EMA) in order to be licensed. These criteria currently apply exclusively to SRH and HI assays and refer to two different target groups—healthy adults and the elderly, but other vaccine recipient age groups have not been considered (i.e., children). The purpose of this timely review is to highlight the current scenario on correlates of protection concerning influenza vaccines and underline the need to revise the criteria and assays currently in use. In addition to SRH and HI assays, the technical advantages provided by other techniques such as the VN assay, pseudotype-based neutralization assay, neuraminidase and cell-mediated immunity assays need to be considered and regulated via EMA criteria, considering the many significant advantages that they could offer for the development of effective vaccines. PMID:26344888

Office-Based Point of Care Testing (IgA/IgG-Deamidated Gliadin Peptide) for Celiac Disease.

PubMed

Lau, Michelle S; Mooney, Peter D; White, William L; Rees, Michael A; Wong, Simon H; Hadjivassiliou, Marios; Green, Peter H R; Lebwohl, Benjamin; Sanders, David S

2018-06-19

Celiac disease (CD) is common yet under-detected. A point of care test (POCT) may improve CD detection. We aimed to assess the diagnostic performance of an IgA/IgG-deamidated gliadin peptide (DGP)-based POCT for CD detection, patient acceptability, and inter-observer variability of the POCT results. From 2013-2017, we prospectively recruited patients referred to secondary care with gastrointestinal symptoms, anemia and/or weight loss (group 1); and patients with self-reported gluten sensitivity with unknown CD status (group 2). All patients had concurrent POCT, IgA-tissue transglutaminase (IgA-TTG), IgA-endomysial antibodies (IgA-EMA), total IgA levels, and duodenal biopsies. Five hundred patients completed acceptability questionnaires, and inter-observer variability of the POCT results was compared among five clinical staff for 400 cases. Group 1: 1000 patients, 58.5% female, age 16-91, median age 57. Forty-one patients (4.1%) were diagnosed with CD. The sensitivities of the POCT, IgA-TTG, and IgA-EMA were 82.9, 78.1, and 70.7%; the specificities were 85.4, 96.3, and 99.8%. Group 2: 61 patients, 83% female; age 17-73, median age 35. The POCT had 100% sensitivity and negative predictive value in detecting CD in group 2. Most patients preferred the POCT to venepuncture (90.4% vs. 2.8%). There was good inter-observer agreement on the POCT results with a Fleiss Kappa coefficient of 0.895. The POCT had comparable sensitivities to serology, and correctly identified all CD cases in a gluten sensitive cohort. However, its low specificity may increase unnecessary investigations. Despite its advantage of convenience and rapid results, it may not add significant value to case finding in an office-based setting.

Bile duct adenoma and von Meyenburg complex-like duct arising in hepatitis and cirrhosis: pathogenesis and histological characteristics.

PubMed

Aishima, Shinichi; Tanaka, Yuki; Kubo, Yuichiro; Shirabe, Ken; Maehara, Yoshihiko; Oda, Yoshinao

2014-11-01

Morphologic features and neoplastic potentials of bile duct adenoma (BDA) and von Meyenburg complex (VMC)-like duct arising in chronic liver disease were unknown. Thirty-five BDAs and 12 VMC-like duct lesions were observed in 39 cases with chronic liver disease. BDAs were divided into the EMA-cytoplasmic type (n = 14) and EMA-luminal type (n = 21). EMA-cytoplasmic BDA composed of a proliferation of cuboidal to low-columnar cells forming an open lumen with NCAM(+)/MUC6(-), resembling an interlobular bile duct. EMA-luminal BDA showed uniform cuboidal cells with narrow lumen, and NCAM(++)/MUC6(++), resembling a ductular reaction. VMC-like duct showed positive MUC1 expression and negative MUC6. The expression of S100P, glucose transporter-1 (GLUT-1) and insulin-like growth factor II mRNA-binding protein 3 (IMP-3) were not detected in three lesions. p16 expression was higher than those of the ductular reaction, and the Ki67 and p53 indexes were very low (<1.0%). Large-sized EMA-luminal BDA shows sclerotic stroma. We classified small nodular lesions of ductal or ductular cells in chronic hepatitis and cirrhosis into the following groups: BDA, interlobular bile duct type; BDA, ductular/peribiliary gland type; and VMC-like duct. They may be reactive proliferation rather than neoplastic lesions. © 2014 Japanese Society of Pathology and Wiley Publishing Asia Pty Ltd.

Inconsistencies among European Union Pharmaceutical Regulator Safety Communications: A Cross-Country Comparison

PubMed Central

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

2014-01-01

Background The European Medicines Agency (EMA) and national regulators share the responsibility to communicate to healthcare providers postmarketing safety events but little is known about the consistency of this process. We aimed to compare public availability of safety-related communications and drug withdrawals from the EMA and European Union member countries for novel medicines. Methods and Findings We performed a cross-sectional analysis using public Dear Healthcare Professional Communications (DHPCs) for all novel medicines authorized between 2001 and 2010 by the EMA and available for use in France, Netherlands, Spain, and the United Kingdom. Between 2001 and 2010, the EMA approved 185 novel medicines. DHPCs could not be ascertained for the EMA. Among the 4 national regulators, as of April 30, 2013, at least one safety DHPC or withdrawal occurred for 53 (28.6%) medicines, totaling 90 DHPCs and 5 withdrawals. Among these 53 medicines, all 4 national agencies issued at least one communication for 17 (32.1%), three of the four for 25 (47.2%), two of the four for 6 (11.3%), and one of the four for 5 (9.4%). Five drugs were reported to be withdrawn, three by all four countries, one by three and one by two. Among the 95 DHPCs and withdrawals, 20 (21.1%) were issued by all 4 national regulators, 37 (38.9%) by 3 of the 4, 22 (23.2%) by 2 of the 4, and 16 (16.8%) by one. Consistency of making publicly available all identified safety DHPC or withdrawal across regulator pairs varied from 33% to 73% agreement. Conclusions Safety communications were not made publicly available by the EMA. Among the 4 European member countries with national regulators that make DHPCs publicly available since at least 2001, there were substantial inconsistencies in safety communications for novel medicines. The impact of those inconsistencies in terms of public health remains to be determined. PMID:25333986

Prescription errors before and after introduction of electronic medication alert system in a pediatric emergency department.

PubMed

Sethuraman, Usha; Kannikeswaran, Nirupama; Murray, Kyle P; Zidan, Marwan A; Chamberlain, James M

2015-06-01

Prescription errors occur frequently in pediatric emergency departments (PEDs).The effect of computerized physician order entry (CPOE) with electronic medication alert system (EMAS) on these is unknown. The objective was to compare prescription errors rates before and after introduction of CPOE with EMAS in a PED. The hypothesis was that CPOE with EMAS would significantly reduce the rate and severity of prescription errors in the PED. A prospective comparison of a sample of outpatient, medication prescriptions 5 months before and after CPOE with EMAS implementation (7,268 before and 7,292 after) was performed. Error types and rates, alert types and significance, and physician response were noted. Medication errors were deemed significant if there was a potential to cause life-threatening injury, failure of therapy, or an adverse drug effect. There was a significant reduction in the errors per 100 prescriptions (10.4 before vs. 7.3 after; absolute risk reduction = 3.1, 95% confidence interval [CI] = 2.2 to 4.0). Drug dosing error rates decreased from 8 to 5.4 per 100 (absolute risk reduction = 2.6, 95% CI = 1.8 to 3.4). Alerts were generated for 29.6% of prescriptions, with 45% involving drug dose range checking. The sensitivity of CPOE with EMAS in identifying errors in prescriptions was 45.1% (95% CI = 40.8% to 49.6%), and the specificity was 57% (95% CI = 55.6% to 58.5%). Prescribers modified 20% of the dosing alerts, resulting in the error not reaching the patient. Conversely, 11% of true dosing alerts for medication errors were overridden by the prescribers: 88 (11.3%) resulted in medication errors, and 684 (88.6%) were false-positive alerts. A CPOE with EMAS was associated with a decrease in overall prescription errors in our PED. Further system refinements are required to reduce the high false-positive alert rates. © 2015 by the Society for Academic Emergency Medicine.

Mechanisms underlying clinical efficacy of Angiotensin II type 2 receptor (AT2R) antagonist EMA401 in neuropathic pain: clinical tissue and in vitro studies.

PubMed

Anand, Uma; Yiangou, Yiangos; Sinisi, Marco; Fox, Michael; MacQuillan, Anthony; Quick, Tom; Korchev, Yuri E; Bountra, Chas; McCarthy, Tom; Anand, Praveen

2015-06-26

The clinical efficacy of the Angiotensin II (AngII) receptor AT2R antagonist EMA401, a novel peripherally-restricted analgesic, was reported recently in post-herpetic neuralgia. While previous studies have shown that AT2R is expressed by nociceptors in human DRG (hDRG), and that EMA401 inhibits capsaicin responses in cultured hDRG neurons, the expression and levels of its endogenous ligands AngII and AngIII in clinical neuropathic pain tissues, and their signalling pathways, require investigation. We have immunostained AngII, AT2R and the capsaicin receptor TRPV1 in control post-mortem and avulsion injured hDRG, control and injured human nerves, and in cultured hDRG neurons. AngII, AngIII, and Ang-(1-7) levels were quantified by ELISA. The in vitro effects of AngII, AT2R agonist C21, and Nerve growth factor (NGF) were measured on neurite lengths; AngII, NGF and EMA401 effects on expression of p38 and p42/44 MAPK were measured using quantitative immunofluorescence, and on capsaicin responses using calcium imaging. AngII immunostaining was observed in approximately 75% of small/medium diameter neurons in control (n = 5) and avulsion injured (n = 8) hDRG, but not large neurons i.e. similar to TRPV1. AngII was co-localised with AT2R and TRPV1 in hDRG and in vitro. AngII staining by image analysis showed no significant difference between control (n = 12) and injured (n = 13) human nerves. AngII levels by ELISA were also similar in control human nerves (4.09 ± 0.36 pmol/g, n = 31), injured nerves (3.99 ± 0.79 pmol/g, n = 7), and painful neuromas (3.43 ± 0.73 pmol/g, n = 12); AngIII and Ang-(1-7) levels were undetectable (<0.03 and 0.05 pmol/g respectively). Neurite lengths were significantly increased in the presence of NGF, AngII and C21 in cultured DRG neurons. AngII and, as expected, NGF significantly increased signal intensity of p38 and p42/44 MAPK, which was reversed by EMA401. AngII mediated sensitization of capsaicin responses was not observed in the presence of MAP kinase inhibitor PD98059, and the kinase inhibitor staurosporine. The major AT2R ligand in human peripheral nerves is AngII, and its levels are maintained in injured nerves. EMA401 may act on paracrine/autocrine mechanisms at peripheral nerve terminals, or intracrine mechanisms, to reduce neuropathic pain signalling in AngII/NGF/TRPV1-convergent pathways.

Physical Activity and Variation in Momentary Behavioral Cognitions: An Ecological Momentary Assessment Study.

PubMed

Pickering, Trevor A; Huh, Jimi; Intille, Stephen; Liao, Yue; Pentz, Mary Ann; Dunton, Genevieve F

2016-03-01

Decisions to perform moderate-to-vigorous physical activity (MVPA) involve behavioral cognitive processes that may differ within individuals depending on the situation. Ecological momentary assessment (EMA) was used to examine the relationships of momentary behavioral cognitions (ie, self-efficacy, outcome expectancy, intentions) with MVPA (measured by accelerometer). A sample of 116 adults (mean age, 40.3 years; 72.4% female) provided real-time EMA responses via mobile phones across 4 days. Multilevel models were used to test whether momentary behavioral cognitions differed across contexts and were associated with subsequent MVPA. Mixed-effects location scale models were used to examine whether subject-level means and within-subjects variances in behavioral cognitions were associated with average daily MVPA. Momentary behavioral cognitions differed across contexts for self-efficacy (P = .007) but not for outcome expectancy (P = .53) or intentions (P = .16). Momentary self-efficacy, intentions, and their interaction predicted MVPA within the subsequent 2 hours (Ps < .01). Average daily MVPA was positively associated with within-subjects variance in momentary self-efficacy and intentions for physical activity (Ps < .05). Although momentary behavioral cognitions are related to subsequent MVPA, adults with higher average MVPA have more variation in physical activity self-efficacy and intentions. Performing MVPA may depend more on how much behavioral cognitions vary across the day than whether they are generally high or low.

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

PubMed

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

2017-12-01

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

Associations between sleep disturbance and alcohol drinking: A large-scale epidemiological study of adolescents in Japan.

PubMed

Morioka, Hisayoshi; Itani, Osamu; Kaneita, Yoshitaka; Ikeda, Maki; Kondo, Shuji; Yamamoto, Ryuichiro; Osaki, Yoneatsu; Kanda, Hideyuki; Higuchi, Susumu; Ohida, Takashi

2013-12-01

In this study, we attempted to clarify the associations between various sleep disturbance symptoms and the frequency and amount of alcohol use among Japanese adolescents. This study was designed as a cross-sectional sampling survey. A self-administered questionnaire survey was administered to students enrolled in randomly selected junior and senior high schools throughout Japan. A total of 99,416 adolescents responded, and 98,867 questionnaires were subjected to analysis. The prevalence rates of sleep disturbance in the 30 days preceding the day of the survey were as follows: subjectively insufficient sleep (SIS) (boys: 37.6%, girls: 38.7%); short sleep duration (SSD) with less than 6 h of sleep (boys: 28.0%, girls: 33.0%); difficulty initiating sleep (DIS) (boys: 12.5%, girls: 14.1%); difficulty maintaining sleep (DMS) (boys: 10.1%, girls: 10.9%); and early morning awakening (EMA) (boys: 5.1%, girls: 5.0%). Adolescents reporting one or more symptoms of DIS, DMS, and EMA were classified as having insomnia, and its prevalence was 21.5%. The prevalence of each symptom of sleep disturbance increased significantly with the number of days on which alcohol was consumed in the previous 30 days and the amount of alcohol consumed per drinking session (p < 0.01). Multiple logistic regression analyses showed that the adjusted odds ratio (AOR) for each symptom of sleep disturbance, except SIS and EMA, tended to increase with the number of days on which alcohol was consumed and the amount of alcohol consumed per drinking session. The prevalence of sleep disturbance is particularly high among adolescents drinking alcohol. The risk of having each symptom of sleep disturbance, except SIS and EMA, increases with the number of days on which alcohol was consumed and the amount of alcohol consumed per drinking session. These findings reconfirm the need to eliminate underage drinking to ensure good sleep among adolescents. Copyright © 2013 Elsevier Inc. All rights reserved.

Registering medicines for low-income countries: how suitable are the stringent review procedures of the World Health Organisation, the US Food and Drug Administration and the European Medicines Agency?

PubMed

Doua, Joachim Y; Van Geertruyden, Jean-Pierre

2014-01-01

New medicines are registered after a resource-demanding process. Unfortunately, in low-income countries (LICs), demand outweighs resources. To facilitate registration in LICs, stringent review procedures of the European Medicines Agency (EMA Article-58), Food and Drug Administration (FDA PEPFAR-linked review) and WHO Prequalification programme have been established. Only the PEPFAR-linked review gives approval, while the others make recommendations for approval. This study assessed the performance and discussed the challenges of these three stringent review procedures. Data from WHO, FDA, EMA, Medline and Internet were analysed. Over 60% of medicines reviewed by stringent review procedures are manufactured in India. Until 2012, WHO prequalified 400 medicines (211 vaccines, 130 antiretrovirals, 29 tuberculostatics, 15 antimalarials and 15 others). PEPFAR-linked review approved 156 antiretrovirals, while EMA Article 58 recommended approval of 3 antiretrovirals, 1 vaccine and 1 antimalarial. WHO Prequalification and PEPFAR-linked review are free of charge and as a result have accelerated access to antiretrovirals. They both built capacity in sub-Saharan Africa, although WHO prequalification relies technically on stringent regulatory authorities and financially on donors. Article-58 offers the largest disease coverage and strongest technical capacities, is costly and involves fewer LICs. To meet the high demand for quality medicines in LICs, these stringent review procedures need to enlarge their disease coverage. To improve registration, EMA Article 58 should actively involve LICs. Furthermore, LIC regulatory activities must not be fully resigned to stringent review procedure. © 2013 John Wiley & Sons Ltd.

Fracture of the proximal tibia after revision total knee arthroplasty with an extensor mechanism allograft.

PubMed

Klein, Gregg R; Levine, Harlan B; Sporer, Scott M; Hartzband, Mark A

2013-02-01

Extensor mechanism reconstruction with an extensor mechanism allograft (EMA) remains one of the most reliable methods for treating the extensor mechanism deficient total knee arthroplasty. We report 3 patients who were treated with an EMA who sustained a proximal tibial shaft fracture. In all 3 cases, a short tibial component was present that ended close to the level of the distal extent of the bone block. When performing an EMA, it is important to recognize that the tibial bone block creates a stress riser and revision to a long-stemmed tibial component should be strongly considered to bypass this point to minimize the risk of fracture. Copyright © 2013 Elsevier Inc. All rights reserved.

Early morning awakening and nonrestorative sleep are associated with increased minor non-fatal accidents during work and leisure time.

PubMed

Chiu, Hsiao-Yean; Wang, Mei-Yeh; Chang, Cheng-Kuei; Chen, Ching-Min; Chou, Kuei-Ru; Tsai, Jen-Chen; Tsai, Pei-Shan

2014-10-01

The relationship between a composite measure of insomnia and occupational or fatal accidents has been investigated previously; however, little is known regarding the effect of various insomnia symptoms on minor non-fatal accidents during work and leisure time. We investigated the predicting role of insomnia symptoms on minor non-fatal accidents during work and leisure time. Data from the 2005 Taiwan Social Development Trend Survey of 36,473 Taiwanese aged ≥18 years were analyzed in 2013. Insomnia symptoms, including difficulty in initiating sleep (DIS), difficulty in maintaining sleep (DMS), early morning awakening (EMA), and nonrestorative sleep (NRS) were investigated. A minor non-fatal accident was defined as any mishap such as forgetting to turn off the gas or faucets, accidental falls, and abrasions or cuts occurring during work and leisure time in the past month that do not require immediate medical attention. Multivariable logistic regression was performed to assess the odds ratios (ORs) and associated 95% confidence interval (CI) of minor non-fatal accidents (as a binary variable) for each insomnia symptom compared with those of people presenting no symptoms, while controlling for possible confounders. EMA and NRS increased the odds of minor non-fatal accidents occurring during work and leisure time (adjusted OR=1.19, 95% CI=1.08-1.32 and adjusted OR=1.27, 95% CI=1.17-1.37, respectively). EMA and NRS are two symptoms that are significantly associated with an increased likelihood of minor non-fatal accidents during work and leisure time after adjusting for of a range of covariates. Copyright © 2014 Elsevier Ltd. All rights reserved.

Breast carcinoma metastasis to the lacrimal gland: Two case reports

PubMed Central

NICKELSEN, MARIE N.; VON HOLSTEIN, SARAH; HANSEN, ALASTAIR B.; PRAUSE, JAN U.; HEEGAARD, STEFFEN

2015-01-01

A 77-year-old female, with proptosis, reduced eye motility and diplopia which had developed over two to three months and a 69-year-old female with proptosis, oedema of the eyelid, reduced motility and ptosis, which had developed over three weeks, are presented in the present study. Computed tomography scans revealed irregular lacrimal gland tumours in the two patients. The two patients had history of breast cancer. The first breast cancer metastasis in the lacrimal gland demonstrated a cribriform growth pattern containing ductal elements. The epithelial tumour cells stained positive for cytokeratin (1–8, 10, 14–16, 18 and 19), oestrogen receptor, epithelial membrane antigen (EMA), carcinoembryonic antigen (CEA) and gross cystic disease fluid protein 15 (GCDFP-15). The second metastatic tumour was positive for EMA and estrogen receptor, but variably positive for CEA and GCDFP-15. The metastasis in the lacrimal gland was a pleomorphic tumour. The tumour cells were positive for EMA and variably positive for oestrogen and CEA. Metastases to the lacrimal gland are extremely rare, and metastases to the lacrimal gland should be considered in the diagnoses of lacrimal gland tumours. The present study aimed to describe two such cases and draw attention to breast carcinomas as a differential diagnosis and the most frequent cause of lacrimal gland metastasis. PMID:26622620

Understanding phenomena in the real world: the case for real time data collection in health services research.

PubMed

Jones, Martyn; Johnston, Derek

2011-07-01

Understanding the environmental and behavioural predictors of wellbeing is a key driver of health and social care research. Research set in the social world examines the relationships between behavioural, cognitive, emotional and environmental factors, linking these to disease or social ills with the aim of providing better preventive or treatment services. Much of this research is based on retrospective measurement tools, such as questionnaires or interviews. However, retrospective accounts are prone to bias arising from the influence of the participant's current affective state on autobiographical memory and error-inducing heuristic strategies related to memory. Participant introspection also biases self-reports of behaviour and symptoms. This essay offers a critical examination of the advantages of ecological momentary assessment (EMA) methods over retrospective accounts in understanding social phenomena. Advantages of EMA include collection of longitudinal data from a representative part of the participant's daily experience, in real time and in the participant's natural environment. EMA accounts are gathered more closely in time to the event and are less biased by heuristic, autobiographical memory strategies. Real-time longitudinal data may be combined from a range of devices or forms of data collection; for example, self-report can be linked with objective physiological data. EMA allows testing of within-person variation in variables of interest in a way that is difficult to achieve using retrospective measures and between-person (group level) designs. EMA approaches provide not just more data, but better data than previously, allowing the application of more powerful analytic techniques to critical, real life questions than ever before.

Combined use of epithelial membrane antigen and nuclear matrix protein 52 as sensitive biomarkers for detection of bladder cancer.

PubMed

Attallah, Abdelfattah M; El-Far, Mohamed; Abdallah, Sanaa O; El-Waseef, Ahmed M; Omran, Mohamed M; Abdelrazek, Mohamed A; Attallah, Ahmed A; Saadh, Mohamed J; Radwan, Mohamed; El-waffaey, Kholoud A; Abol-Enei, Hassan

2015-11-11

The advent of noninvasive urine-based markers as well as other novel modalities has yielded improved diagnostic accuracy. However, the new markers failed to reach higher sensitivity and specificity. We therefore evaluated the potential role of epithelial membrane antigen (EMA) and nuclear matrix protein 52 (NMP-52) singly and combined as noninvasive biomarkers for the detection of bladder cancer (BC). A total of 160 individuals including 66 patients with BC, 54 patients with benign urologic disorders and 40 healthy volunteers were investigated. Urinary EMA at 130 kDa and NMP at 52 kDa were identified, purified and quantified by Western blot, electroelution and enzyme-linked immunosorbent assay (ELISA). The diagnostic performance of each biomarker and their combination were compared using area under receiver operating characteristic curves (AUC). Mean urinary EMA, 2.42 µg/mL, and NMP-52, 17.85 µg/mL, were significantly elevated in patients with BC compared to controls, 1.18 and 3.44 µg/mL, respectively (p<0.0001). The combined use of these markers yielded values which were increased 4.4- and 13.7-fold in the benign and malignant disease groups, respectively, with respect to the normal group. The values of EMA and NMP-52 were significantly higher in patients with higher-grade tumors than those with lower-grade tumors (p<0.0001). Moreover, this combination could predict all BC stages and grades with 0.91 AUC, 94% sensitivity and 80% specificity. EMA and NMP-52 in combination could be promising noninvasive biomarkers for BC detection.

Energy materials coordinating committee (EMaCC). Annual technical report, fiscal year 2005

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

None, None

2006-09-29

The DOE Energy Materials Coordinating Committee (EMaCC) serves primarily to enhance coordination among the Department's materials programs and to further effective use of materials expertise within the Department. These functions are accomplished through the exchange of budgetary and planning information among program managers and through technical meetings/workshops on selected topics involving both DOE and major contractors. In addition, EMaCC assists in obtaining materials-related inputs for both intra- and interagency compilations. Topical subcommittees of the EMaCC are responsible for conducting seminars and otherwise facilitating information flow between DOE organizational units in materials areas of particular importance to the Department. The EMaCCmore » Terms of Reference were recently modified and developed into a Charter that was approved on June 5, 2003. As a result of this reorganization, the existing subcommittees were disbanded and new subcommittees are being formed. The FY 2004 budget summary for DOE Materials Activities is presented on page 8. The distribution of these funds between DOE laboratories, private industry, academia and other organizations is presented in tabular form on page 10. Following the budget summary is a set of detailed program descriptions for the FY 2004 DOE Materials activities. These descriptions are presented according to the organizational structure of the Department. A mission statement, a budget summary listing the project titles and FY 2004 funding, and detailed project summaries are presented for each Assistant Secretary office, the Office of Science, and the National Nuclear Security Administration. The project summaries also provide DOE, laboratory, academic and industrial contacts for each project, as appropriate.« less

Drug use patterns and predictors among homeless youth: results of an ecological momentary assessment.

PubMed

Santa Maria, Diane; Padhye, Nikhil; Yang, Yijiong; Gallardo, Kathryn; Santos, Glenn-Milo; Jung, Julie; Businelle, Michael

2017-12-29

Alcohol and drug use is associated with significant morbidity and mortality and is highly prevalent among homeless youth. Ecological Momentary Assessments (EMA) have been used to examine the effect of urges on drug use, though not among homeless youth. We assessed the patterns of drug use and the correlation between real-time contextual factors and drug use using EMA collected daily. We identified predictors of drug use among a sample of homeless youth 18-25 years old in Houston, Texas. Homeless youth (n = 66, 62% male) were recruited from a drop-in center between September 2015 and May 2016. We used generalized linear mixed models and cross-validation methods to determine the best predictive model of drug use. The overall drug use was high: 61% and 32% of participants reported using drugs or alcohol at least one day, respectively. Marijuana and synthetic marijuana use (i.e., Kush, K2, incense packs) were reported most frequently; 86% and 13% of the total drug use EMAs, respectfully. Drug use urge was reported on 26% of days and was the highest on drug use days. Drug use was predicted by discrimination, pornography use, alcohol use, and urges for drugs, alcohol, and to steal. EMA can be used to predict drug use among homeless youth. Drug use treatment among homeless youth should address the role of experiencing discrimination, pornography and alcohol use, and urge management strategies on drug use. Research is needed to determine if EMA informed just-in-time interventions targeting these predictors can reduce use.

Energy materials coordinating committee (EMaCC). Annual technical report, fiscal year 2004

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

none,

2005-08-31

The DOE Energy Materials Coordinating Committee (EMaCC) serves primarily to enhance coordination among the Department's materials programs and to further effective use of materials expertise within the Department. These functions are accomplished through the exchange of budgetary and planning information among program managers and through technical meetings/workshops on selected topics involving both DOE and major contractors. In addition, EMaCC assists in obtaining materials-related inputs for both intra- and interagency compilations. Topical subcommittees of the EMaCC are responsible for conducting seminars and otherwise facilitating information flow between DOE organizational units in materials areas of particular importance to the Department. The EMaCCmore » Terms of Reference were recently modified and developed into a Charter that was approved on June 5, 2003. As a result of this reorganization, the existing subcommittees were disbanded and new subcommittees are being formed. The FY 2004 budget summary for DOE Materials Activities is presented on page 8. The distribution of these funds between DOE laboratories, private industry, academia and other organizations is presented in tabular form on page 10. Following the budget summary is a set of detailed program descriptions for the FY 2004 DOE Materials activities. These descriptions are presented according to the organizational structure of the Department. A mission statement, a budget summary listing the project titles and FY 2004 funding, and detailed project summaries are presented for each Assistant Secretary office, the Office of Science, and the National Nuclear Security Administration. The project summaries also provide DOE, laboratory, academic and industrial contacts for each project, as appropriate.« less

Kinematic Analysis of Lingual Movements during Consonant Productions in Dysarthric Speakers with Friedreich's Ataxia: A Case-by-Case Analysis

ERIC Educational Resources Information Center

Folker, Joanne E.; Murdoch, Bruce E.; Cahill, Louise M.; Delatycki, Martin B.; Corben, Louise A.; Vogel, Adam P.

2011-01-01

Articulatory kinematics were investigated using electromagnetic articulography (EMA) in four dysarthric speakers with Friedreich's ataxia (FRDA). Specifically, tongue-tip and tongue-back movements were recorded by the AG-200 EMA system during production of the consonants t and k as produced within a sentence utterance and during a rapid syllable…

PlenadrEMA: effect of dual-release versus conventional hydrocortisone on fatigue, measured by ecological momentary assessments: a study protocol for an open-label switch pilot study.

PubMed

Boesen, Victor Brun; Christoffersen, Thea; Watt, Torquil; Borresen, Stina Willemoes; Klose, Marianne; Feldt-Rasmussen, Ulla

2018-01-23

Patients with adrenal insufficiency have impaired health-related quality of life (QoL). The dual-release hydrocortisone preparation, Plenadren, has been developed to mimic the physiological cortisol release more closely than conventional hydrocortisone treatment. Plenadren has been shown to improve QoL, in particular fatigue, in patients with primary adrenal insufficiency. However, the effect has not been investigated in patients with secondary adrenal insufficiency; furthermore, no study has taken the diurnal variation of fatigue into account. To assess diurnal variations, it is necessary to use repeated daily measurements, such as ecological momentary assessments (EMAs). This study aims to evaluate EMAs of fatigue as outcome in future large-scale randomised clinical trials. The PlenadrEMA trial is an investigator-initiated open-label switch pilot trial of the effect of Plenadren versus conventional hydrocortisone on fatigue in patients with secondary adrenal insufficiency. The trial will include 30 participants. After 5 weeks on their usual hydrocortisone treatment, patients will be shifted to Plenadren for 16 weeks. Fatigue will be assessed using momentary versions of the Multidimensional Fatigue Inventory (MFI-20). Items will be administered to participants via a smartphone application four times daily during 20 days. Assessments will be performed before treatment shift and repeated after 12.5 weeks on Plenadren. The study will identify the best suited outcome for future randomised clinical trials, and in addition, estimate the variability and difference in fatigue between the two treatments to perform power calculations. The trial will be conducted in accordance with the Declaration of Helsinki and has been approved by the Regional Scientific Ethical Committee in Copenhagen (ID: H-1-2014-073). All patients will receive written and verbal information about the trial and will give informed consent before enrolment. Findings will be published in peer-reviewed journals and presented at international conferences. EudraCT201400203932. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Feasibility of ecological momentary assessment of hearing difficulties encountered by hearing aid users

PubMed Central

Galvez, Gino; Turbin, Mitchel B.; Thielman, Emily J.; Istvan, Joseph A.; Andrews, Judy A.; Henry, James A.

2012-01-01

Objectives Measurement of outcomes has become increasingly important to assess the benefit of audiologic rehabilitation, including hearing aids, in adults. Data from questionnaires, however, are based on retrospective recall of events and experiences, and often can be inaccurate. Questionnaires also do not capture the daily variation that typically occurs in relevant events and experiences. Clinical researchers in a variety of fields have turned to a methodology known as ecological momentary assessment (EMA) to assess quotidian experiences associated with health problems. The objective of this study was to determine the feasibility of using EMA to obtain real-time responses from hearing aid users describing their experiences with challenging hearing situations. Design This study required three phases: (1) develop EMA methodology to assess hearing difficulties experienced by hearing aid users; (2) utilize focus groups to refine the methodology; and (3) test the methodology with 24 hearing aid users. Phase 3 participants carried a personal digital assistant (PDA) 12 hr per day for 2 wk. The PDA alerted participants to respond to questions four times a day. Each assessment started with a question to determine if a hearing problem was experienced since the last alert. If “yes,” then up to 23 questions (depending on contingent response branching) obtained details about the situation. If “no,” then up to 11 questions obtained information that would help to explain why hearing was not a problem. Each participant completed the Hearing Handicap Inventory for the Elderly (HHIE) both before and after the 2-wk EMA testing period to evaluate for “reactivity” (exacerbation of self-perceived hearing problems that could result from the repeated assessments). Results Participants responded to the alerts with a 77% compliance rate, providing a total of 991 completed momentary assessments (mean = 43.1 per participant). A substantial amount of data was obtained with the methodology. Notably, participants reported a “hearing problem situation since the last alert” 37.6% of the time (372 responses). The most common problem situation involved “face-to-face conversation” (53.8% of the time). The next most common problem situation was “telephone conversation” (17.2%) followed by “TV, radio, iPod, etc.” (15.3%), “environmental sounds” (9.7%), and “movies, lecture, etc.” (4.0%). Comparison of pre- and post-EMA mean HHIE scores revealed no significant difference (p>.05), indicating that reactivity did not occur for this group. It should be noted, however, that 37.5% of participants reported a greater sense of awareness regarding their hearing loss and use of hearing aids. Conclusions Results showed participants were compliant, gave positive feedback, and did not demonstrate reactivity based on pre- and post-HHIE scores. We conclude that EMA methodology is feasible with patients who use hearing aids and could potentially inform hearing healthcare (HHC) services. The next step is to develop and evaluate EMA protocols that provide detailed daily patient information to audiologists at each stage of HHC. The advantages of such an approach would be to obtain real-life outcome measures, and to determine within- and between-day variability in outcomes and associated factors. Such information currently is not available from patients who seek and use HHC services. PMID:22531573

Feasibility of ecological momentary assessment of hearing difficulties encountered by hearing aid users.

PubMed

Galvez, Gino; Turbin, Mitchel B; Thielman, Emily J; Istvan, Joseph A; Andrews, Judy A; Henry, James A

2012-01-01

Measurement of outcomes has become increasingly important to assess the benefit of audiologic rehabilitation, including hearing aids, in adults. Data from questionnaires, however, are based on retrospective recall of events and experiences, and often can be inaccurate. Questionnaires also do not capture the daily variation that typically occurs in relevant events and experiences. Clinical researchers in a variety of fields have turned to a methodology known as ecological momentary assessment (EMA) to assess quotidian experiences associated with health problems. The objective of this study was to determine the feasibility of using EMA to obtain real-time responses from hearing aid users describing their experiences with challenging hearing situations. This study required three phases: (1) develop EMA methodology to assess hearing difficulties experienced by hearing aid users; (2) make use of focus groups to refine the methodology; and (3) test the methodology with 24 hearing aid users. Phase 3 participants carried a personal digital assistant 12 hr per day for 2 weeks. The personal digital assistant alerted participants to respond to questions four times a day. Each assessment started with a question to determine whether a hearing problem was experienced since the last alert. If "yes," then up to 23 questions (depending on contingent response branching) obtained details about the situation. If "no," then up to 11 questions obtained information that would help to explain why hearing was not a problem. Each participant completed the Hearing Handicap Inventory for the Elderly (HHIE) both before and after the 2-week EMA testing period to evaluate for "reactivity" (exacerbation of self-perceived hearing problems that could result from the repeated assessments). Participants responded to the alerts with a 77% compliance rate, providing a total of 991 completed momentary assessments (mean = 43.1 per participant). A substantial amount of data were obtained with the methodology. It is important to note that participants reported a "hearing problem situation since the last alert" 37.6% of the time (372 responses). The most common problem situation involved "face-to-face conversation" (53.8% of the time). The next most common problem situation was "telephone conversation" (17.2%) followed by "TV, radio, iPod, etc." (15.3%), "environmental sounds" (9.7%), and "movies, lecture, etc." (4.0%). Comparison of pre- and post-EMA mean HHIE scores revealed no significant difference (p > 0.05), indicating that reactivity did not occur for this group. It should be noted, however, that 37.5% of participants reported a greater sense of awareness regarding their hearing loss and use of hearing aids. Results showed participants were compliant, gave positive feedback, and did not demonstrate reactivity based on pre- and post-HHIE scores. We conclude that EMA methodology is feasible with patients who use hearing aids and could potentially inform hearing healthcare (HHC) services. The next step is to develop and evaluate EMA protocols that provide detailed daily patient information to audiologists at each stage of HHC. The advantages of such an approach would be to obtain real-life outcome measures, and to determine within- and between-day variability in outcomes and associated factors. Such information at present is not available from patients who seek and use HHC services.

ESPGHAN 2012 Guidelines for Coeliac Disease Diagnosis: Validation Through a Retrospective Spanish Multicentric Study.

PubMed

Donat, Ester; Ramos, Jose M; Sánchez-Valverde, Félix; Moreno, Ana; Martinez, Maria-Jose; Leis, Rosaura; Peña-Quintana, Luis; Castillejo, Gemma; Fernández, Sonia; Garcia, Zuriñe; Ortigosa, Luis; Balmaseda, Elena; Marugán, José-Manuel; Eizaguirre, Francisco-Javier; Lorenzo, Helena; Barrio, Josefa; Ribes-Koninckx, Carmen

2016-02-01

A large retrospective multicentre study was conducted in Spain to evaluate the efficiency of the new European Society for Pediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN) criteria for the diagnosis of coeliac disease (CD). The study protocol was approved by the ethics committee of Hospital Universitari i Politècnic La Fe (Valencia, Spain). The present study included 2177 children (ages 0.6-15.9 years) with small bowel biopsy (SBB) performed for diagnostic purposes (from 2000 to 2009) and with a minimum 2-year follow-up after biopsy. CD was diagnosed in 2126 patients (97.5%) and excluded in 51 (2.5%). Tissue transglutaminase antibodies (TG2A), anti-endomysial antibodies (EMA), and human leukocyte antigen (HLA) were reported in 751 patients, 640 symptomatic and 111 asymptomatic. TG2A levels >10 times the upper limit of normal, plus positive EMA and HLA DQ2 and/or DQ8 haplotypes, were found in 336 symptomatic patients, all of them with final diagnosis of CD. In 65 of 69 asymptomatic patients, 65 had confirmed CD and 4 did not have CD. According to the 2012 ESPGHAN guidelines, SBB may have been omitted in 52% of the symptomatic patients with CD with serologic and HLA available data. Gluten challenge was performed in 158 children, 75 of them <2 years at first biopsy. Only 1 patient in whom according to the new proposed diagnostic criteria gluten challenge would not have been mandatory did not relapse. Our results support the new ESPGHAN 2012 guidelines for diagnosis of CD can be safely used without the risk of overdiagnosis. A prospective multicentre study is needed to confirm our results.

Effectiveness of “Thin-Layer” and “Effective Medium” Approximations in Numerical Simulation of Dielectric Spectra of Biological Cell Suspensions

NASA Astrophysics Data System (ADS)

Asami, Koji

2010-12-01

There are a few concerns in dielectric modeling of biological cells by the finite-element method (FEM) to simulate their dielectric spectra. Cells possess thin plasma membranes and membrane-bound intracellular organelles, requiring extra fine meshes and considerable computational tasks in the simulation. To solve the problems, the “thin-layer” approximation (TLA) and the “effective medium” approximation (EMA) were adopted. TLA deals with the membrane as an interface of the specific membrane impedance, and therefore it is not necessary to divide the membrane region. EMA regards the composite cytoplasm as an effective homogeneous phase whose dielectric properties are calculated separately. It was proved that TLA and EMA were both useful for greatly reducing computational tasks while accurately coinciding with analytical solutions.

EMA assessment of tongue-jaw co-ordination during speech in dysarthria following traumatic brain injury.

PubMed

Bartle, Carly J; Goozée, Justine V; Scott, Dion; Murdoch, Bruce E; Kuruvilla, Mili

2006-05-01

To investigate the spatio-timing aspects of tongue-jaw co-ordination during speech in individuals with traumatic brain injury (TBI). It was hypothesized that both timing and spatial co-ordination would be affected by TBI. A group comparison design wherein Mann-Whitney U-tests were used to compare non-neurologically impaired individuals with individuals with TBI. Nine non-neurologically impaired adults and nine adults with TBI were involved in the study. Electromagnetic articulography (EMA) was used to track tongue and jaw movement during /t/ and /k/, embedded in sentence and syllable stimuli. Analysis of group data did not reveal a significant difference in spatio-timing tongue-jaw co-ordination between the control group and TBI group. On an individual basis, a proportion of individuals with TBI differed from non-neurologically impaired participants with regard to articulatory order and percentage of jaw contribution to /t/. EMA assessment results supported perceptual data; those adults who presented with severe articulatory disturbances exhibited the most deviant spatio-timing tongue-jaw co-ordination patterns. This finding could provide a new and specific direction for treatment, directed at combined movement patterns.

Comparing Presenting Clinical Features in 48 Children With Microscopic Polyangiitis to 183 Children Who Have Granulomatosis With Polyangiitis (Wegener's): An ARChiVe Cohort Study.

PubMed

Cabral, David A; Canter, Debra L; Muscal, Eyal; Nanda, Kabita; Wahezi, Dawn M; Spalding, Steven J; Twilt, Marinka; Benseler, Susanne M; Campillo, Sarah; Charuvanij, Sirirat; Dancey, Paul; Eberhard, Barbara A; Elder, Melissa E; Hersh, Aimee; Higgins, Gloria C; Huber, Adam M; Khubchandani, Raju; Kim, Susan; Klein-Gitelman, Marisa; Kostik, Mikhail M; Lawson, Erica F; Lee, Tzielan; Lubieniecka, Joanna M; McCurdy, Deborah; Moorthy, Lakshmi N; Morishita, Kimberly A; Nielsen, Susan M; O'Neil, Kathleen M; Reiff, Andreas; Ristic, Goran; Robinson, Angela B; Sarmiento, Angelyne; Shenoi, Susan; Toth, Mary B; Van Mater, Heather A; Wagner-Weiner, Linda; Weiss, Jennifer E; White, Andrew J; Yeung, Rae S M

2016-10-01

To uniquely classify children with microscopic polyangiitis (MPA), to describe their demographic characteristics, presenting clinical features, and initial treatments in comparison to patients with granulomatosis with polyangiitis (Wegener's) (GPA). The European Medicines Agency (EMA) classification algorithm was applied by computation to categorical data from patients recruited to the ARChiVe (A Registry for Childhood Vasculitis: e-entry) cohort, with the data censored to November 2015. The EMA algorithm was used to uniquely distinguish children with MPA from children with GPA, whose diagnoses had been classified according to both adult- and pediatric-specific criteria. Descriptive statistics were used for comparisons. In total, 231 of 440 patients (64% female) fulfilled the classification criteria for either MPA (n = 48) or GPA (n = 183). The median time to diagnosis was 1.6 months in the MPA group and 2.1 months in the GPA group (ranging to 39 and 73 months, respectively). Patients with MPA were significantly younger than those with GPA (median age 11 years versus 14 years). Constitutional features were equally common between the groups. In patients with MPA compared to those with GPA, pulmonary manifestations were less frequent (44% versus 74%) and less severe (primarily, hemorrhage, requirement for supplemental oxygen, and pulmonary failure). Renal pathologic features were frequently found in both groups (75% of patients with MPA versus 83% of patients with GPA) but tended toward greater severity in those with MPA (primarily, nephrotic-range proteinuria, requirement for dialysis, and end-stage renal disease). Airway/eye involvement was absent among patients with MPA, because these GPA-defining features preclude a diagnosis of MPA within the EMA algorithm. Similar proportions of patients with MPA and those with GPA received combination therapy with corticosteroids plus cyclophosphamide (69% and 78%, respectively) or both drugs in combination with plasmapheresis (19% and 22%, respectively). Other treatments administered, ranging in decreasing frequency from 13% to 3%, were rituximab, methotrexate, azathioprine, and mycophenolate mofetil. Younger age at disease onset and, perhaps, both gastrointestinal manifestations and more severe kidney disease seem to characterize the clinical profile in children with MPA compared to those with GPA. Delay in diagnosis suggests that recognition of these systemic vasculitides is suboptimal. Compared with adults, initial treatment regimens in children were comparable, but the complete reversal of female-to-male disease prevalence ratios is a provocative finding. © 2016, American College of Rheumatology.

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

PubMed Central

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

2015-01-01

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

Cognitive-behavioural therapy for heroin and cocaine use: Ecological momentary assessment of homework simplification and compliance.

PubMed

Willner-Reid, Jessica; Whitaker, Damiya; Epstein, David H; Phillips, Karran A; Pulaski, Amber R; Preston, Kenzie L; Willner, Paul

2016-09-01

The purpose of this study was to evaluate the effects of homework-task difficulty and electronic-diary reminders on written homework completion during cognitive-behavioural therapy (CBT) for addiction. Completion of homework is an important element in CBT that may affect outcome. All participants received all combinations of our two interventions in a factorial 2 × 2 counterbalanced Latin-square design. Methadone-maintained cocaine and heroin users were given homework between each of 12 weekly CBT sessions and carried electronic diaries that collected ecological momentary assessment (EMA) data on craving and exposure to drug-use triggers in four 3-week blocks assessing two levels of homework difficulty and prompted and unprompted homework. Neither simplified (picture-based) homework nor electronic reminders increased homework completion. In EMA reports, standard but not simplified homework seemed to buffer the craving that followed environmental exposure to drug cues. EMA recordings before and after the CBT intervention confirmed a decrease over time in craving for cocaine and heroin. These findings demonstrate the utility of EMA to assess treatment effects. However, the hypothesis that simplified homework would increase compliance was not supported. Our simplifications of homework assignments for cognitive-behavioural therapy were mostly ineffective, or even counterproductive, perhaps because they did not engage sufficient depth of processing or because they were perceived as too simplistic. Our reminder beeps for homework were mostly ineffective, or even counterproductive, suggesting that mobile electronic interventions for substance-use disorders may need to be more interactive. Published 2015. This article is a U.S. Government work and is in the public domain in the USA.

Regulatory Scientific Advice on Non-Inferiority Drug Trials

PubMed Central

Knol, Mirjam J.; Klungel, Olaf H.; Gispen-De Wied, Christine C.; de Boer, Antonius; Hoes, Arno W.; Leufkens, Hubert G.; Mantel-Teeuwisse, Aukje K.

2013-01-01

The active-controlled trial with a non-inferiority design has gained popularity in recent years. However, non-inferiority trials present some methodological challenges, especially in determining the non-inferiority margin. Regulatory guidelines provide some general statements on how a non-inferiority trial should be conducted. Moreover, in a scientific advice procedure, regulators give companies the opportunity to discuss critical trial issues prior to the start of the trial. The aim of this study was to identify potential issues that may benefit from more explicit guidance by regulators. To achieve this, we collected and analyzed questions about non-inferiority trials posed by applicants for scientific advice in Europe in 2008 and 2009, as well as the responses given by the European Medicines Agency (EMA). In our analysis we included 156 final letters of advice from 2008 and 2009, addressed to 94 different applicants (manufacturers). Our analysis yielded two major findings: (1) applicants frequently asked questions ‘whether’ and ‘how’ to conduct a non-inferiority trial, 26% and 74%, respectively, and (2) the EMA regulators seem mainly concerned about the choice of the non-inferiority margin in non-inferiority trials (36% of total regulatory answers). In 40% of the answers, the EMA recommended using a stricter margin, and in 10% of the answers regarding non-inferiority margins, the EMA questioned the justification of the proposed non-inferiority margin. We conclude that there are still difficulties in selecting the appropriate methodology for non-inferiority trials. Straightforward and harmonized guidance regarding non-inferiority trials is required, for example on whether it is necessary to conduct such a trial and how the non-inferiority margin is determined. It is unlikely that regulatory guidelines can cover all therapeutic areas; therefore, in some cases regulatory scientific advice may be used as an opportunity for tailored advice. PMID:24040346

Altered leverage around the ankle in people with diabetes: A natural strategy to modify the muscular contribution during walking?

PubMed

Petrovic, Milos; Deschamps, Kevin; Verschueren, Sabine M; Bowling, Frank L; Maganaris, Constantinos N; Boulton, Andrew J M; Reeves, Neil D

2017-09-01

Diabetes patients display gait alterations compared to controls including a higher metabolic cost of walking. This study aimed to investigate whether differences in external moment arm (ExtMA) and effective mechanical advantage (EMA) at the ankle in diabetes patients could partly explain the increased cost of walking compared to controls. Thirty one non-diabetic controls (Ctrl); 22 diabetes patients without peripheral neuropathy (DM) and 14 patients with moderate/severe diabetic peripheral neuropathy (DPN) underwent gait analysis using a motion analysis system and force plates. The internal Achilles tendon moment arm length was determined using magnetic resonance imaging during weight-bearing and ExtMA was calculated using gait analysis. A greater value (P<0.01) for the EMA at the ankle was found in the DPN (0.488) and DM (0.46) groups compared to Ctrl (0.448). The increased EMA was mainly caused by a smaller ExtMA in the DPN (9.63cm; P<0.01) and DM (10.31cm) groups compared to Ctrl (10.42cm) These findings indicate that the ankle plantarflexor muscles would need to generate lower forces to overcome the external resistance during walking compared to controls. Our findings do not explain the previously observedhigher metabolic cost of walking in the DM and DPN groups, but uncover a new mechanism through which patients with diabetes and particularly those with DPN reduce the joint moment at the ankle during walking: by applying the ground reaction force more proximally on the foot, or at an angle directed more towards the ankle, thereby increasing the EMA and reducing the ankle joint moment. Copyright © 2017. Published by Elsevier B.V.

Development of an ecological momentary assessment scale for appetite.

PubMed

Kikuchi, Hiroe; Yoshiuchi, Kazuhiro; Inada, Shuji; Ando, Tetsuya; Yamamoto, Yoshiharu

2015-01-01

An understanding of eating behaviors is an important element of health education and treatment in clinical populations. To understand the biopsychosocial profile of eating behaviors in an ecologically valid way, ecological momentary assessment (EMA) is appropriate because its use is able to overcome the recall bias in patient-reported outcomes (PROs). As appetite is a key PRO associated with eating behaviors, this study was done to develop an EMA scale to evaluate the within-individual variation of momentary appetite and uses this scale to discuss the relationships between appetite and various psychological factors. Twenty healthy participants (age 23.6 ± 4.2 years old) wore a watch-type computer for a week. Several times a day, including just before and after meals, they recorded their momentary psychological stress, mood states, and ten items related to appetite. In addition, they recorded everything they ate and drank into a personal digital assistant (PDA)-based food diary. Multilevel factor analysis was used to investigate the factor structure of the scale, and the reliability and validity of the scale were also explored. Multilevel factor analyses found two factors at the within-individual level (hunger/fullness and cravings) and one factor at the between-individual level. Medians for the individually calculated Cronbach's alphas were 0.89 for hunger/fullness, 0.71 for cravings, and 0.86 for total appetite (the sum of all items). Hunger/fullness, cravings, and total appetite all decreased significantly after meals compared with those before meals, and hunger/fullness, cravings, and total appetite before meals were positively associated with energy intake. There were significant negative associations between both hunger/fullness and total appetite and anxiety and depression as well as between cravings, and depression, anxiety and stress. The within-individual reliability of the EMA scale to assess momentary appetite was confirmed in most subjects and it was also validated as a useful tool to understand eating behaviors in daily settings. Further refinement of the scale is necessary and further investigations need to be conducted, particularly on clinical populations.

EMA-qPCR to monitor the efficiency of a closed-coupled solar pasteurization system in reducing Legionella contamination of roof-harvested rainwater.

PubMed

Reyneke, B; Dobrowsky, P H; Ndlovu, T; Khan, S; Khan, W

2016-05-15

Solar pasteurization is effective in reducing the level of indicator organisms in stored rainwater to within drinking water standards. However, Legionella spp. were detected at temperatures exceeding the recommended pasteurization temperatures using polymerase chain reaction assays. The aim of the current study was thus to apply EMA quantitative polymerase chain reaction (EMA-qPCR) to determine whether the Legionella spp. detected were intact cells and therefore possibly viable at pasteurization temperatures >70°C. The BacTiter-Glo™ Microbial Cell Viability Assay was also used to detect the presence of ATP in the tested samples, as ATP indicates the presence of metabolically active cells. Chemical analysis also indicated that all anions and cations were within the respective drinking water guidelines, with the exception of iron (mean: 186.76 μg/L) and aluminium (mean: 188.13 μg/L), which were detected in the pasteurized tank water samples at levels exceeding recommended guidelines. The BacTiter-Glo™ Microbial Cell Viability Assay indicated the presence of viable cells for all pasteurized temperatures tested, with the percentage of ATP (in the form of relative light units) decreasing with increasing temperature [70-79°C (96.7%); 80- 89°C (99.2%); 90-95°C (99.7%)]. EMA-qPCR then indicated that while solar pasteurization significantly reduced (p<0.05) the genomic copy numbers of intact Legionella cells in the pasteurized tank water (~99%), no significant difference (p>0.05) in the mean copy numbers was detected with an increase in the pasteurization temperature, with 6 × 10(3) genomic copies/mL DNA sample obtained at 95°C. As intact Legionella cells were detected in the pasteurized tank water samples, quantitative microbial risk assessment studies need to be conducted to determine the potential health risk associated with using the water for domestic purposes. Copyright © 2016 Elsevier B.V. All rights reserved.

The presence of anti-endomysial antibodies and the level of anti-tissue transglutaminases can be used to diagnose adult coeliac disease without duodenal biopsy.

PubMed

Tortora, R; Imperatore, N; Capone, P; De Palma, G D; De Stefano, G; Gerbino, N; Caporaso, N; Rispo, A

2014-11-01

The new ESPGHAN guidelines for diagnosis of paediatric coeliac disease suggest to avoid biopsy in genetically pre-disposed and symptomatic individuals with positive anti-endomysial antibodies (EMA) and anti-tissue transglutaminases (a-tTG). However, duodenal biopsy remains the gold standard in adult coeliac disease. To establish the cut-off values of a-tTG, which would: predict the presence of duodenal histology (Marsh ≥2) diagnostic for coeliac disease; and predict the presence of villous atrophy (Marsh 3) in adults. We performed an observational prospective study including all consecutive adult patients with suspected coeliac disease. All subjects were tested for EMA and a-tTG. Coeliac disease diagnosis was made in presence of Marsh ≥2, a-tTG >7 U/mL and positive EMA. A ROC curve was constructed to establish the best specificity cut-off of a-tTG levels, which would predict the presence of Marsh ≥2 and Marsh 3 at histology. The study included 310 patients with positive antibodies. Histology showed Marsh 1 in 8.7%, Marsh 2 in 3.5%, Marsh 3 in 87.7%. The best cut-off value of a-tTG for predicting Marsh ≥2 was 45 U/mL (sensitivity 70%; specificity 100%; PPV 100%; NPV 24.1%); the best cut-off for predicting villous atrophy was 62.4 U/mL (sensitivity 69%, specificity 100%; PPV 100%; NPV 31%). The diagnosis of coeliac disease can be reached without histology in adult patients with positive EMA and a-tTG levels >45 U/mL. An a-tTG level >62.4 was diagnostic for villous atrophy. These results could contribute to improving the diagnosis of coeliac disease by allowing for a significant reduction in diagnosis-related costs. © 2014 John Wiley & Sons Ltd.

QTL and gene expression analyses identify genes affecting carcass weight and marbling on BTA14 in Hanwoo (Korean Cattle).

PubMed

Lee, Seung Hwan; van der Werf, J H J; Kim, Nam Kuk; Lee, Sang Hong; Gondro, C; Park, Eung Woo; Oh, Sung Jong; Gibson, J P; Thompson, J M

2011-10-01

Causal mutations affecting quantitative trait variation can be good targets for marker-assisted selection for carcass traits in beef cattle. In this study, linkage and linkage disequilibrium analysis (LDLA) for four carcass traits was undertaken using 19 markers on bovine chromosome 14. The LDLA analysis detected quantitative trait loci (QTL) for carcass weight (CWT) and eye muscle area (EMA) at the same position at around 50 cM and surrounded by the markers FABP4SNP2774C>G and FABP4_μsat3237. The QTL for marbling (MAR) was identified at the midpoint of markers BMS4513 and RM137 in a 3.5-cM marker interval. The most likely position for a second QTL for CWT was found at the midpoint of tenth marker bracket (FABP4SNP2774C>G and FABP4_μsat3237). For this marker bracket, the total number of haplotypes was 34 with a most common frequency of 0.118. Effects of haplotypes on CWT varied from a -5-kg deviation for haplotype 6 to +8 kg for haplotype 23. To determine which genes contribute to the QTL effect, gene expression analysis was performed in muscle for a wide range of phenotypes. The results demonstrate that two genes, LOC781182 (p = 0.002) and TRPS1 (p = 0.006) were upregulated with increasing CWT and EMA, whereas only LOC614744 (p = 0.04) has a significant effect on intramuscular fat (IMF) content. Two genetic markers detected in FABP4 were the most likely QTL position in this QTL study, but FABP4 did not show a significant effect on both traits (CWT and EMA) in gene expression analysis. We conclude that three genes could be potential causal genes affecting carcass traits CWT, EMA, and IMF in Hanwoo.

Lessons learned on the design and the conduct of Post-Authorization Safety Studies: review of 3 years of PRAC oversight.

PubMed

Engel, Pierre; Almas, Mariana Ferreira; De Bruin, Marieke Louise; Starzyk, Kathryn; Blackburn, Stella; Dreyer, Nancy Ann

2017-04-01

To describe and characterize the first cohort of Post-Authorization Safety Study (PASS) protocols reviewed under the recent European pharmacovigilance legislation. A systematic approach was used to compile all publicly available information on PASS protocols and assessments submitted from July 2012 to July 2015 from Pharmacovigilance Risk Assessment Committee (PRAC) minutes, European Medicines Agency (EMA) and European Network of Pharmacovigilance and Pharmacoepidemiology (ENCePP) webpages. During the study period, 189 different PASS protocols were submitted to the PRAC, half of which were entered in the ENCePP electronic register of post-authorization studies (EU-PAS) by July 2015. Those protocols were assessed during 353 PRAC reviews. The EMA published only 31% of the PRAC feedback, of which the main concerns were study design (37%) and feasibility (30%). Among the 189 PASS, slightly more involved primary data capture (58%). PASS assessing drug utilization mainly leveraged secondary data sources (58%). The majority of the PASS did not include a comparator (65%) and 35% of PASS also evaluated clinical effectiveness endpoints. To the best of our knowledge this is the first comprehensive review of three years of PASS protocols submitted under the new pharmacovigilance legislation. Our results show that both EMA and PASS sponsors could respectively increase the availability of protocol assessments and documents in the EU-PAS. Protocol content review and the high number of PRAC comments related to methodological issues and feasibility concerns should raise awareness among PASS stakeholders to design more thoughtful studies according to pharmacoepidemiological principles and existing guidelines. © 2016 The British Pharmacological Society.

[New drugs in oncology--features of clinical trials for market authorisation and arguments for the rapid implementation of independent clinical trials following approval].

PubMed

Ludwig, Wolf-Dieter; Schott, Gisela

2013-01-01

The market authorisation or extension of indication for all oncology drugs in Europe is now based on Regulation (EC) No. 726/2004, a centralised procedure of the European Medicines Agency (EMA). Studies in recent years have highlighted deficiencies in pivotal studies. For example, the requirements of the EMA are not always consistently followed and studies are stopped prematurely after only interim analysis that at this time point shows improved efficacy with regard to the comparator arm. Our current analysis of the European Assessment Reports (reporting period: 01/01/2009 to 08/13/2012) on 29 drugs for 39 oncology indications shows that the quality of the trials for market authorisation has improved in several respects. Primary endpoints recommended by the EMA and the Food and Drug Administration (FDA) such as overall survival and progression-free survival are used, and only one study was conducted as a phase II trial with no comparator arm. In contrast, oncology drugs that are approved for the treatment of rare diseases (orphan drugs) are based on small studies which are often carried out without blinding, are not randomised and investigate surrogate endpoints. To answer patient-relevant issues following market authorisation, it is necessary to conduct independent clinical studies. Increased public funding needs to be provided and bureaucratic hurdles have to be reduced. Only this will permit a more efficient use of limited health care resources and allow to improve the quality of care for cancer patients. Copyright © 2013 S. Karger AG, Basel.

Differing patterns of stress and craving across the day in moderate-heavy alcohol consumers during their typical drinking routine and an imposed period of alcohol abstinence.

PubMed

Mayhugh, Rhiannon E; Rejeski, W Jack; Petrie, Meredith R; Laurienti, Paul J; Gauvin, Lise

2018-01-01

Stress is a known factor related to alcohol use. However, how the relationship between alcohol craving and stress varies across the day is not fully understood. As craving is a consistent predictor of alcohol use disorder (AUD), understanding stress and craving patterns across the day in routine, non-dependent, moderate-heavy alcohol consumers may help in understanding those who may be vulnerable to transitioning into AUD. Moderate-heavy drinkers were recruited from the local community (n = 32) and assessed for fluctuations in craving and stress intensity across the day via Ecological Momentary Assessment (EMA) during 3 consecutive days of imposed alcohol abstinence (abstained trial) and their normal drinking routine (normal trial). A multilevel modeling statistical approach assessed differences in diurnal craving and stress patterns with the Alcohol Craving Experience Questionnaire (ACE) examined as a moderator. Immediately following alcohol consumption on normal trials, EMA craving levels were significantly reduced compared to pre-drinking levels. Moreover, the post-drinking craving levels were lower than on abstained trials. Higher ACE scores were associated with significantly higher EMA craving across the day and higher peaks at midday. Higher ACE scores were also associated with greater EMA stress across the day. Drinking relieved stress relative to abstained trials, but not in individuals with higher ACE scores. Higher stress was associated with greater EMA craving, which was stronger among those with higher ACE scores. These findings suggest that ACE scores are important to understanding patterns of stress and craving experienced across the day in routine, non-dependent, moderate-heavy drinkers and may provide new insights for vulnerability to transitioning into AUD.

Cross-resistance, mode of inheritance and stability of resistance to emamectin in Spodoptera litura (Lepidoptera: Noctuidae).

PubMed

Shad, Sarfraz Ali; Sayyed, Ali H; Saleem, Mushtaq A

2010-08-01

Spodoptera litura (F.) is a cosmopolitan pest that has developed resistance to several insecticides. The aim of the present study was to establish whether an emamectin-selected (Ema-SEL) population could render cross-resistance to other insecticides, and to investigate the genetics of resistance. Bioassays at G(1) gave resistance ratios (RRs) of 80-, 2980-, 3050- and 2800-fold for emamectin, abamectin, indoxacarb and acetamiprid, respectively, compared with a laboratory susceptible population Lab-PK. After three rounds of selection, resistance to emamectin in Ema-SEL increased significantly, with RRs of 730-fold and 13-fold compared with the Lab-PK and unselected (UNSEL) population respectively. Further studies revealed that three generations were required for a tenfold increase in resistance to emamectin. Resistance to abamectin, indoxacarb, acetamiprid and emamectin in UNSEL declined significantly compared with the field population at G(1). Furthermore, selection with emamectin reduced resistance to abamectin, indoxacarb and acetamiprid on a par with UNSEL. Crosses between Ema-SEL and Lab-PK indicated autosomal and incomplete dominance of resistance. A direct test of a monogenic model and Land's method suggested that resistance to emamectin was controlled by more than one locus. Instability of resistance and lack of cross-resistance to other insecticides suggest that insecticides with different modes of action should be recommended to reduce emamectin selection pressure. Copyright (c) 2010 Society of Chemical Industry.

Peel/seal properties of poly(ethylene methyl acrylate)/polybutene-1 blend films

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

Mohammdi, Seyedeh Raziyeh; Ajji, Abdellah; Tabatabaei, Seyed H.

Nowadays, the possibility to easy open a food package is of great interest both from the consumer and food producers’ perspective. In this study, the peel/seal properties of poly (ethylene methyl acrylate) (EMA)/polybutene-1 (PB-1) blend films were investigated. Three blends of EMA/PB-1 with different methyl acrylate (MA) content were prepared using cast extrusion process. Differential Scanning Calorimetry (DSC) was used to investigate the thermal behavior as well as the crystalinity of the blends. The effect of polymer matrix on the crystalline structure of PB-1 was studied using Wide Angle X-ray Diffraction (WAXD) and DSC. T-peel tests were carried out onmore » the heat sealed films at various seal temperatures. The effect of MA content and heat seal temperature on peel/seal properties (i.e. peel initiation temperature, temperature window of sealability and peel strength) of the films were studied.« less

Brief Mindfulness Meditation Training in Smokers

DTIC Science & Technology

2013-03-11

the Use of Mobile Technology EMA involves assessing phenomena at the moment they occur in a person’s natural environment. Assessments may be done at...of mobile technology , especially smartphones and tablet computers, provides a soon-to-be ubiquitous platform that can be leveraged to introduce...acute effects of Brief-MM together with an EMA platform is the first step in developing the knowledge base and technology necessary for using a similar

Perineurial-like Cells and EMA Expression in the Suprachoroidal Region of the Human Eye.

PubMed

Gilbert, Andrea R; Chévez-Barrios, Patricia; Cykowski, Matthew D

2018-05-01

The suprachoroidal region of the eye comprises vascular channels, melanocytes, and thin fibroblasts with elongated cytoplasm that are positioned directly adjacent to the densely collagenous sclera. Morphological similarities between these suprachoroidal fibroblasts and arachnoid cells and perineurial cells have been recognized, but whether these fibroblasts have a perineurial cell-like immunophenotype is not known. To further examine the relationship of these three cell types, we investigated the comparative expression of epithelial membrane antigen (EMA), the tight junction protein claudin-1, glucose transporter-1 (Glut-1), and CD34 in suprachoroidal fibroblasts, arachnoid of the optic nerve sheath, and perineurium of ciliary nerves in eight human eye specimens. Granular, diffuse, and cytoplasmic EMA expression was seen in suprachoroidal fibroblasts, but this was not contiguous with the similar pattern of EMA expression in adjacent perineurium and arachnoid. CD34 expression in suprachoroidal fibroblasts was also seen, similar to arachnoid and perineurium. Claudin-1 and Glut-1 were not consistently expressed in suprachoroidal fibroblasts, distinguishing them from perineurial cells in particular and suggesting that these fibroblasts do not arise directly from adjacent arachnoid or perineurium. Nonetheless, the overlapping morphology and protein expression suggest phenotypic similarities in these cells that protect and support adjacent retina, optic nerve, and peripheral nerve.

Associations of Affective Responses During Free-Living Physical Activity and Future Physical Activity Levels: an Ecological Momentary Assessment Study.

PubMed

Liao, Yue; Chou, Chih-Ping; Huh, Jimi; Leventhal, Adam; Dunton, Genevieve

2017-08-01

Affective response during physical activity may influence motivation to perform future physical activity behavior. However, affective response during physical activity is often assessed under controlled laboratory conditions. The current study used ecological momentary assessment (EMA) to capture affective responses during free-living physical activity performed by adults, and determined whether these affective responses predict future moderate-to-vigorous physical activity (MVPA) levels after 6 and 12 months. At baseline, electronic EMA surveys were randomly prompted across 4 days asking about current activities and affective states (e.g., happy, stressed, energetic, tired). Affective response during physical activity was operationalized as the level of positive or negative affect reported when concurrent physical activity (e.g., exercise or sports) was also reported. Data were available for 82 adults. Future levels of moderate-to-vigorous physical activity (MVPA) were measured using accelerometers, worn for seven consecutive days at 6 and 12 months after the baseline assessment. Feeling more energetic during physical activity was associated with performing more minutes of daily MVPA after both 6 and 12 months. Feeling less negative affect during physical activity was associated with engaging in more daily MVPA minutes after 12 months only. This study demonstrated how EMA can be used to capture affective responses during free-living physical activity. Results found that feelings more energetic and less negative during physical activity were associated with more future physical activity, suggesting that positive emotional benefits may reinforce behavior.

Smartphone-based ecological momentary assessment and intervention in a coping-focused intervention for hearing voices (SAVVy): study protocol for a pilot randomised controlled trial.

PubMed

Bell, Imogen H; Fielding-Smith, Sarah F; Hayward, Mark; Rossell, Susan L; Lim, Michelle H; Farhall, John; Thomas, Neil

2018-05-02

Smartphone-based ecological momentary assessment and intervention (EMA/I) show promise for enhancing psychological treatments for psychosis. EMA has the potential to improve assessment and formulation of experiences which fluctuate day-to-day, and EMI may be used to prompt use of therapeutic strategies in daily life. The current study is an examination of these capabilities in the context of a brief, coping-focused intervention for distressing voice hearing experiences. This is a rater-blinded, pilot randomised controlled trial comparing a four-session intervention in conjunction with use of smartphone EMA/I between sessions, versus treatment-as-usual. The recruitment target is 34 participants with persisting and distressing voice hearing experiences, recruited through a Voices Clinic based in Melbourne, Australia, and via wider advertising. Allocation will be made using minimisation procedure, balancing of the frequency of voices between groups. Assessments are completed at baseline and 8 weeks post-baseline. The primary outcomes of this trial will focus on feasibility and acceptability of the intervention and trial methodology, with secondary outcomes examining preliminary clinical effects related to overall voice severity, the emotional and functional impact of the voices, and emotional distress. This study offers a highly novel examination of specific smartphone capabilities and their integration with traditional psychological treatment for distressing voices. Such technology has potential to enhance psychological interventions and promote adaptation to distressing experiences. Australian New Zealand Clinical Trial Registry, ACTRN12617000348358 . Registered on 7 March 2017.

Emergence of Sex Differences in Insomnia Symptoms in Adolescents: A Large-Scale School-Based Study

PubMed Central

Zhang, Jihui; Chan, Ngan Yin; Lam, Siu Ping; Li, Shirley Xin; Liu, Yaping; Chan, Joey W.Y.; Kong, Alice Pik Shan; Ma, Ronald C.W.; Chan, Kate C.C.; Li, Albert Martin; Wing, Yun-Kwok

2016-01-01

Study Objectives: This study aimed to explore the moderation of pubertal status on the onset of sex differences in the prevalence of insomnia symptoms and their health correlates. Methods: A total of 7,507 children and adolescents (weighted percentage of female: 48.5%) aged between 6–17 y were recruited from thirty-one primary and secondary schools. Participants with difficulty initiating sleep (DIS), difficulty maintaining sleep (DMS), and/or early morning awakening (EMA) ≥ 3 times/week in the past month were considered as having insomnia symptoms. The severity of insomnia was measured by the Insomnia Severity Index (ISI). Results: The prevalence of insomnia symptoms increased from 3.4% to 12.2% in girls (3.6-fold) and from 4.3% to 9.1% in boys (2.1-fold) from Tanner stage 1 to 5. There was a significant interaction between sex and Tanner stage in the prevalence of insomnia (P < 0.001) with an emergence of female preponderance at Tanner stage 4 even after controlling for age, family income, and school start time. Similar sex-Tanner stage interactions were found in DIS, DMS, and ISI total score but not EMA. Insomnia symptoms were strongly associated with behavioral problems, poor mental health, and poor general health in both sexes. Boys with insomnia would report more maladaptive lifestyles (smoking, alcohol, and energy drinks) whereas girls with insomnia were more susceptible to emotional and relationship difficulties. Conclusions: Pubertal maturation was associated with a progressive increase in the prevalence of insomnia symptoms with the emergence of female preponderance in both the prevalence and severity of insomnia symptoms at late puberty. Clinical Trials Registration: Chinese Clinical Trial Register, http://www.chictr.org.cn, ID: ChiCTR-TRC-12002798 Citation: Zhang J, Chan NY, Lam SP, Li SX, Liu Y, Chan JW, Kong AP, Ma RC, Chan KC, Li AM, Wing YK. Emergence of sex differences in insomnia symptoms in adolescents: a large-scale school-based study. SLEEP 2016;39(8):1563–1570. PMID:27091537

Ecological momentary assessment of daily discrimination experiences and nicotine, alcohol, and drug use among sexual and gender minority individuals.

PubMed

Livingston, Nicholas A; Flentje, Annesa; Heck, Nicholas C; Szalda-Petree, Allen; Cochran, Bryan N

2017-12-01

Sexual and gender minority (SGM) individuals experience elevated rates of minority stress, which has been linked to higher rates of nicotine and substance use. Research on this disparity to date is largely predicated on methodology that is insensitive to within day SGM-based discrimination experiences, or their relation to momentary nicotine and substance use risk. We address this knowledge gap in the current study using ecological momentary assessment (EMA). Fifty SGM individuals, between 18 and 45 years of age, were recruited from an inland northwestern university, regardless of their nicotine or substance use history, and invited to participate in an EMA study. Each were prompted to provide data, six times daily (between 10:00 a.m. and 10:00 p.m.) for 14 days, regarding SGM-based discrimination, other forms of mistreatment, and nicotine, drug, and alcohol use since their last prompt. Discrimination experiences that occurred since individuals' last measurement prompt were associated with greater odds of nicotine and substance use during the same measurement window. Substance use was also more likely to occur in relation to discrimination reported two measurements prior in lagged models. Relative to other forms of mistreatment, discrimination effects were consistently larger in magnitude and became stronger throughout the day/evening. This study adds to existing minority stress research by highlighting the both immediate and delayed correlates of daily SGM-based discrimination experiences. These results also contribute to our understanding of daily stress processes and provide insight into ways we might mitigate these effects using real-time monitoring and intervention technology. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Drug development for exceptionally rare metabolic diseases: challenging but not impossible.

PubMed

Putzeist, Michelle; Mantel-Teeuwisse, Aukje K; Wied, Christine C Gispen-de; Hoes, Arno W; Leufkens, Hubert G M; de Vrueh, Remco L A

2013-11-15

We studied to what extent the level of scientific knowledge on exceptionally rare metabolic inherited diseases and their potential orphan medicinal products is associated with sponsors deciding to apply for an orphan designation at the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA). All metabolic diseases with a genetic cause and prevalence of less than 10 patients per 1 million of the population were selected from the 'Orphanet database of Rare diseases'. The outcome of interest was the application for an orphan designation at FDA or EMA. The level of publicly available knowledge of the disease and drug candidate before an orphan designation application was defined as whether the physiological function corresponding with the pathologic gene and initiation of the pathophysiological pathway was known, whether an appropriate animal study was identified for the disease, whether preclinical proof of concept was ascertained and the availability of data in humans. Other determinants included in the study were metabolic disease class, the prevalence of the disease, prognosis and time of first description of the disease in the literature. Univariate relative risks (RRs) and 95% confidence intervals (CIs) of an orphan designation application were calculated for each of these determinants. In addition, a multivariate Cox regression analysis was conducted (Forward LR). In total, 166 rare metabolic genetic diseases were identified and included in the analysis. For only 42 (25%) of the diseases an orphan designation application was submitted at either FDA or EMA before January 2012. The multivariate analysis identified preclinical proof of concept of a potential medicinal product as major knowledge related determinant associated with an orphan designation application (RRadj 3.9, 95% CI 1.9-8.3) and confirmed that prevalence of the disease is also associated with filing an application for an orphan designation (RRadj 2.8, 95% CI 1.4-5.4). For only one out of four known exceptionally rare metabolic inherited diseases sponsors applied for an orphan designation at FDA or EMA. These applications were found to be associated with the prevalence of the rare disease and the level of available scientific knowledge on the proof of concept linking possible drug candidates to the disease of interest.

Design and test of a high power electromechanical actuator for thrust vector control

NASA Technical Reports Server (NTRS)

Cowan, J. R.; Myers, W. N.

1992-01-01

NASA-Marshall is involved in the development of electromechanical actuators (EMA) for thrust-vector control (TVC) system testing and implementation in spacecraft control/gimballing systems, with a view to the replacement of hydraulic hardware. TVC system control is furnished by solid state controllers and power supplies; a pair of resolvers supply position feedback to the controller for precise positioning. Performance comparisons between EMA and hydraulic TVC systems are performed.

Energy Materials Coordinating Committee (EMaCC), Fiscal year 1992. Annual technical report

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

Not Available

The DOE EMaCC serves to coordinate the department`s materials programs and to further effective use of materials expertise within the department. This document presents summaries of budgets and of research projects, arranged according to the offices of energy efficiency and renewable energy, energy research, environmental restoration and waste management, nuclear energy, civilian radioactive waste management, defense, and fossil energy. A directory and a keyword index are included.

Electronic Materials and Applications 2014 (Abstracts)

DTIC Science & Technology

2015-04-02

the thermal image using IR camera and surface tempera- ture using thermo couple. Lastly, we conducted a surface coating to change the surface...progress in the superconducting films and coated conductors of iron chalcogenides. With a CeO2 buffer , critical current densities (Jc) over 7 MA/cm2...Roosen, University of Erlangen-Nuremberg, Germany Kato, N. 23-Jan 11:15AM Pacific 11:30 AM (EMA-S1-021-2014) Glass-like Thermal Conductivity of (010

Design and test of a high power electromechanical actuator for thrust vector control

NASA Astrophysics Data System (ADS)

Cowan, J. R.; Myers, W. N.

1992-07-01

NASA-Marshall is involved in the development of electromechanical actuators (EMA) for thrust-vector control (TVC) system testing and implementation in spacecraft control/gimballing systems, with a view to the replacement of hydraulic hardware. TVC system control is furnished by solid state controllers and power supplies; a pair of resolvers supply position feedback to the controller for precise positioning. Performance comparisons between EMA and hydraulic TVC systems are performed.

Flywheel energy storage for electromechanical actuation systems

NASA Technical Reports Server (NTRS)

Hockney, Richard L.; Goldie, James H.; Kirtley, James L.

1991-01-01

The authors describe a flywheel energy storage system designed specifically to provide load-leveling for a thrust vector control (TVC) system using electromechanical actuators (EMAs). One of the major advantages of an EMA system over a hydraulic system is the significant reduction in total energy consumed during the launch profile. Realization of this energy reduction will, however, require localized energy storage capable of delivering the peak power required by the EMAs. A combined flywheel-motor/generator unit which interfaces directly to the 20-kHz power bus represents an ideal candidate for this load leveling. The overall objective is the definition of a flywheel energy storage system for this application. The authors discuss progress on four technical objectives: (1) definition of the specifications for the flywheel-motor/generator system, including system-level trade-off analysis; (2) design of the flywheel rotor; (3) design of the motor/generator; and (4) determination of the configuration for the power management system.

Flywheel energy storage for electromechanical actuation systems

NASA Astrophysics Data System (ADS)

Hockney, Richard L.; Goldie, James H.; Kirtley, James L.

The authors describe a flywheel energy storage system designed specifically to provide load-leveling for a thrust vector control (TVC) system using electromechanical actuators (EMAs). One of the major advantages of an EMA system over a hydraulic system is the significant reduction in total energy consumed during the launch profile. Realization of this energy reduction will, however, require localized energy storage capable of delivering the peak power required by the EMAs. A combined flywheel-motor/generator unit which interfaces directly to the 20-kHz power bus represents an ideal candidate for this load leveling. The overall objective is the definition of a flywheel energy storage system for this application. The authors discuss progress on four technical objectives: (1) definition of the specifications for the flywheel-motor/generator system, including system-level trade-off analysis; (2) design of the flywheel rotor; (3) design of the motor/generator; and (4) determination of the configuration for the power management system.

Electromechanical actuation for thrust vector control applications

NASA Technical Reports Server (NTRS)

Roth, Mary Ellen

1990-01-01

The advanced launch system (ALS), is a launch vehicle that is designed to be cost-effective, highly reliable, and operationally efficient with a goal of reducing the cost per pound to orbit. An electromechanical actuation (EMA) system is being developed as an attractive alternative to the hydraulic systems. The controller will integrate 20 kHz resonant link power management and distribution (PMAD) technology and pulse population modulation (PPM) techniques to implement field-oriented vector control (FOVC) of a new advanced induction motor. The driver and the FOVC will be microprocessor controlled. For increased system reliability, a built-in test (BITE) capability will be included. This involves introducing testability into the design of a system such that testing is calibrated and exercised during the design, manufacturing, maintenance, and prelaunch activities. An actuator will be integrated with the motor controller for performance testing of the EMA thrust vector control (TVC) system. The EMA system and work proposed for the future are discussed.

Thermal modal analysis of novel non-pneumatic mechanical elastic wheel based on FEM and EMA

NASA Astrophysics Data System (ADS)

Zhao, Youqun; Zhu, Mingmin; Lin, Fen; Xiao, Zhen; Li, Haiqing; Deng, Yaoji

2018-01-01

A combination of Finite Element Method (FEM) and Experiment Modal Analysis (EMA) have been employed here to characterize the structural dynamic response of mechanical elastic wheel (ME-Wheel) operating under a specific thermal environment. The influence of high thermal condition on the structural dynamic response of ME-Wheel is investigated. The obtained results indicate that the EMA results are in accordance with those obtained using the proposed Finite Element (FE) model, indicting the high reliability of this FE model applied in analyzing the modal of ME-Wheel working under practical thermal environment. It demonstrates that the structural dynamic response of ME-Wheel operating under a specific thermal condition can be predicted and evaluated using the proposed analysis method, which is beneficial for the dynamic optimization design of the wheel structure to avoid tire temperature related vibration failure and improve safety of tire.

Advanced Therapy Medicinal Products: How to Bring Cell-Based Medicinal Products Successfully to the Market - Report from the CAT-DGTI-GSCN Workshop at the DGTI Annual Meeting 2014.

PubMed

Celis, Patrick; Ferry, Nicolas; Hystad, Marit; Schüßler-Lenz, Martina; Doevendans, Pieter A; Flory, Egbert; Beuneu, Claire; Reischl, Ilona; Salmikangas, Paula

2015-05-01

On September 11, 2014, a workshop entitled 'Advanced Therapy Medicinal Products: How to Bring Cell-Based Medicinal Product Successfully to the Market' was held at the 47th annual meeting of the German Society for Transfusion Medicine and Immunohematology (DGTI), co-organised by the European Medicines Agency (EMA) and the DGTI in collaboration with the German Stem Cell Network (GSCN). The workshop brought together over 160 participants from academia, hospitals, small- or medium-sized enterprise developers and regulators. At the workshop, speakers from EMA, the Committee for Advanced Therapies (CAT), industry and academia addressed the regulatory aspects of development and authorisation of advanced therapy medicinal products (ATMPs), classification of ATMPs and considerations on cell-based therapies for cardiac repair. The open forum discussion session allowed for a direct interaction between ATMP developers and the speakers from EMA and CAT.

The Role of Sexual Abuse and Dysfunctional Attitudes in Perceived Stress and Negative Mood in Pregnant Adolescents: An Ecological Momentary Assessment Study

PubMed Central

Walsh, Kate; Basu, Archana; Monk, Catherine

2014-01-01

Study Objective Latinas have the highest rates of adolescent pregnancy in the US. Identifying means to improve the well-being among these young women is critical. The current study examined whether a history of child sexual abuse — itself a risk factor for adolescent pregnancy — was associated with more perceived stress and negative mood over the course of pregnancy and whether dysfunctional attitudes explained these associations. Design and Setting This mixed methods study involved lab-based assessments of perceived stress, sexual abuse history, and dysfunctional attitudes as well as Ecological Momentary Assessments (EMA) of mood states every 30 minutes during a 24-hour period once during each trimester of pregnancy. Participants Pregnant adolescents (n = 204, 85% Latina). Main Outcome Measures EMA mood states and lab-based retrospective self–reports of perceived stress. Results One in four pregnant adolescents had a history of sexual abuse. Sexually abused adolescents reported greater perceived stress during the first trimester relative to those without, though the groups did not differ on EMA negative mood ratings. Dysfunctional attitudes explained associations between sexual abuse and perceived stress. Sexual abuse was indirectly associated with the intercept and slope of negative mood through dysfunctional attitudes. Findings were circumscribed to sexual abuse and not other types of child abuse. Conclusions Identifying sexually abused pregnant adolescents and providing support and cognitive therapy to target dysfunctional beliefs may decrease stress during the first trimester as well as negative affect throughout pregnancy. PMID:26130137

Revisiting the Affect Regulation Model of Binge Eating: A Meta-Analysis of Studies using Ecological Momentary Assessment

PubMed Central

Haedt-Matt, Alissa A.; Keel, Pamela K.

2011-01-01

The affect regulation model of binge eating, which posits that patients binge eat to reduce negative affect (NA), has received support from cross-sectional and laboratory-based studies. Ecological momentary assessment (EMA) involves momentary ratings and repeated assessments over time and is ideally suited to identify temporal antecedents and consequences of binge eating. This meta-analytic review includes EMA studies of affect and binge eating. Electronic database and manual searches produced 36 EMA studies with N = 968 participants (89% Caucasian women). Meta-analyses examined changes in affect before and after binge eating using within-subjects standardized mean gain effect sizes (ES). Results supported greater NA preceding binge eating relative to average affect (ES = .63) and affect before regular eating (ES = .68). However, NA increased further following binge episodes (ES = .50). Preliminary findings suggested that NA decreased following purging in Bulimia Nervosa (ES = −.46). Moderators included diagnosis (with significantly greater elevations of NA prior to bingeing in Binge Eating Disorder compared to Bulimia Nervosa) and binge definition (with significantly smaller elevations of NA before binge versus regular eating episodes for the DSM definition compared to lay definitions of binge eating). Overall, results fail to support the affect regulation model of binge eating and challenge reductions in NA as a maintenance factor for binge eating. However, limitations of this literature include unidimensional analyses of NA and inadequate examination of affect during binge eating as binge eating may regulate only specific facets of affect or may reduce NA only during the episode. PMID:21574678

Revisiting the affect regulation model of binge eating: a meta-analysis of studies using ecological momentary assessment.

PubMed

Haedt-Matt, Alissa A; Keel, Pamela K

2011-07-01

The affect regulation model of binge eating, which posits that patients binge eat to reduce negative affect (NA), has received support from cross-sectional and laboratory-based studies. Ecological momentary assessment (EMA) involves momentary ratings and repeated assessments over time and is ideally suited to identify temporal antecedents and consequences of binge eating. This meta-analytic review includes EMA studies of affect and binge eating. Electronic database and manual searches produced 36 EMA studies with N = 968 participants (89% Caucasian women). Meta-analyses examined changes in affect before and after binge eating using within-subjects standardized mean gain effect sizes (ESs). Results supported greater NA preceding binge eating relative to average affect (ES = 0.63) and affect before regular eating (ES = 0.68). However, NA increased further following binge episodes (ES = 0.50). Preliminary findings suggested that NA decreased following purging in bulimia nervosa (ES = -0.46). Moderators included diagnosis (with significantly greater elevations of NA prior to bingeing in binge eating disorder compared to bulimia nervosa) and binge definition (with significantly smaller elevations of NA before binge vs. regular eating episodes for the Diagnostic and Statistical Manual of Mental Disorders definition compared to lay definitions of binge eating). Overall, results fail to support the affect regulation model of binge eating and challenge reductions in NA as a maintenance factor for binge eating. However, limitations of this literature include unidimensional analyses of NA and inadequate examination of affect during binge eating, as binge eating may regulate only specific facets of affect or may reduce NA only during the episode.

Does social context matter? An ecological momentary assessment study of marijuana use among college students.

PubMed

Phillips, Kristina T; Phillips, Michael M; Lalonde, Trent L; Prince, Mark A

2018-08-01

Past research has shown that marijuana use occurs commonly in social situations for young adults, though few studies have examined the association between immediate social context and marijuana use patterns and associated problems. The current study examined the impact of demographics, marijuana use and problem use, alcohol use, craving, and social context on the likelihood of using marijuana with others via ecological momentary assessment (EMA). College-student marijuana users (N=56) were recruited and completed a baseline assessment and training on the two-week signal-contingent EMA protocol. Participants were sent text messages three times per day randomly for two weeks. Of the 1131 EMA instances during which participants reported using marijuana, 862 (76.22%) were labeled as being with others. Forty-five participants (80.36%) reported marijuana use with others present during at least half of the times they used marijuana. Findings from a multilevel logistic regression model showed a significant positive association between the probability of using with others and minutes spent using marijuana (b=0.047, p<0.001), social facilitation (b=0.138, p<0.001), and DSM-IV diagnosis (dependence versus no diagnosis, b=1.350, p=0.047). Cannabis dependence, more time using marijuana in the moment, and using for social facilitation purposes were positively associated with using marijuana in the context of being with others. Daily users had more variability in terms of the social context of their use. This study illustrates the complex relationship between social context and marijuana use. Copyright © 2018 Elsevier Ltd. All rights reserved.

Review: UK medicines likely to be affected by the proposed European Medicines Agency's guidelines on phthalates.

PubMed

Jamieson, Lisa; McCully, William

2015-06-13

Phthalates are excipients in drug formulations. However, concerns have been raised about the effects of particular phthalates on reproduction and development. As a result the EMA has introduced guidelines for permitted daily exposure (PDE) limits for certain phthalates. Therefore, the objective of this study was to identify UK licensed medicines that contain the relevant phthalates and determine if they fall within the recommended PDE. The eMC was used to identify which UK licensed medicines contain the phthalates in question. Companies were then contacted for information on the phthalate levels in their products, which was compared with the PDE recommended by the EMA. The eMC search revealed that 54 medicines contained at least one of the phthalates in question. However, only six medicines, namely Asacol 800 mg MR (Warner Chilcott UK), Epilim 200 Gastro-resistant tablets (Sanofi), Prednisolone 2.5 mg and 5 mg Gastro-resistant tablets (Actavis UK), Vivotif (Crucell Italy S.r.l), and Zentiva 200 mg Gastro-resistant tablets (Winthrop Pharmaceuticals UK), were identified as containing levels that exceeded the recommended PDE. These findings indicate that very few UK licensed medicines will be affected by the proposed EMA guidelines. For those medicines identified as exceeding recommendations, these findings highlight the need to instigate a risk-benefit review.

Daily social interactions, close relationships, and systemic inflammation in two samples: Healthy middle-aged and older adults.

PubMed

Bajaj, Amoha; John-Henderson, Neha A; Cundiff, Jenny M; Marsland, Anna L; Manuck, Stephen B; Kamarck, Thomas W

2016-11-01

Systemic inflammation is thought to be a biological mediator between social relationship quality and premature mortality. Empirical work has yielded mixed support for an association of social relationship variables with systemic inflammation, perhaps due to methodological limitations. To date, research in this literature has focused on global perceptions of social relationships, with limited attention to the covariance of characteristics of daily social interactions with inflammation. Here, we examine whether daily interactions, as assessed by ecological momentary assessment (EMA), associate with peripheral markers of inflammation among midlife and older adults. Global social support and integration were measured using the Interpersonal Support Evaluation List (ISEL) and the Social Network Index (SNI), respectively, in older adults from the Pittsburgh Healthy Heart Project (PHHP), and in middle-aged adults from the Adult Health and Behavior Project-II (AHAB-II). Using time-sampled EMA, we assessed the proportion of the day spent in positive and negative social interactions. Systemic markers of inflammation were interleukin (IL)-6 and C-reactive protein (CRP). Global measures of support and integration did not associate with inflammation in either sample. In older adults, relative frequency of total positive interactions, those with close others (i.e. spouse, friends, family), and those with coworkers predicted lower concentrations of IL-6 in fully adjusted models, accounting for age, sex, race, education, BMI, smoking and alcohol. In middle-aged adults, relative frequency of positive interactions with close others was also inversely associated with IL-6 level and relative frequency of negative marital interactions was unexpectedly inversely associated with CRP level. Characteristics of daily social interactions among midlife and older adults associate with markers of systemic inflammation that are known to predict risk for cardiovascular disease. Ambulatory measures may better capture health-relevant social processes in daily life than retrospective, global self-report measures. Published by Elsevier Inc.

East Atlantic (EA) and North Atlantic Oscillation (NAO) interplay over the Iberian Peninsula for the last two millennia

NASA Astrophysics Data System (ADS)

Hernandez, A.; Sánchez-López, G.; Pla-Rabes, S.; Trigo, R.; Toro, M.; Granados, I.; Sáez, A.; Masque, P.; Pueyo, J. J.; Rubio-Inglés, M. J.; Giralt, S.

2016-12-01

The multi-proxy approach from sediments of an Iberian alpine lake allowed us to establish the climatic conditions in the Iberian Central Range (ICR) over the last two millennia. The comparison with other Iberian reconstructions permitted to identify possible forcing climate mechanisms. Climatic conditions would be transmitted to the sediments via the frequency of intense run-off events, derived from rain-on-snow events, and the lake productivity, ruled by ice-cover duration. The early Roman Period (RP; 200 BC - 350 AD) in the ICR was characterized by oscillations of intense run-off events, as a consequence of an alternation between cold and warm periods. From the second half of the RP to the onset of the Early Middle Ages (EMA; 350 - 500 AD) an increase in the intense run-off events suggests warm conditions, although a noticeable decrease during the rest of the EMA (500 - 900 AD) evidences a shift to very cold temperatures in this region. In terms of humidity, both RP and EMA climatic periods displayed a transition from a dry to a wet scenario that led to a decrease in lake productivity. These climatic conditions have been registered by other reconstructions in the Iberian Peninsula (IP), and a North-South humidity gradient could be envisaged, although spatial climatic discrepancies were significant. Precipitation and temperature in the IP present a more homogeneous spatial pattern when the NAO and EA modes have the same sign than when they have the opposite sign. Hence, a predominance of periods with NAO - EA in opposite phases could explain the climatic spatial heterogeneity in the IP during these two periods. The Medieval Climate Anomaly (MCA; 900 - 1300 AD) in the ICR was characterized by warm and dry conditions represented by an increase in exceptional run-off episodes and lake productivity whereas the Little Ice Age (LIA; 1300 - 1850 AD) showed the opposite scenario. Similar climatic conditions were registered in all the IP, reflecting a spatial climatic homogeneity. The climatic conditions attributed to the MCA and the LIA are consistent with a change from a predominant positive phase of the NAO during the MCA to a prevalence negative NAO phase during the LIA. Additionally, a predominance in the coincidence of NAO - EA phases (both modes positive during the MCA and both negative during the LIA) could reinforce this spatial homogeneity.

Validity of the Remote Food Photography Method (RFPM) for estimating energy and nutrient intake in near real-time.

PubMed

Martin, Corby K; Correa, John B; Han, Hongmei; Allen, H Raymond; Rood, Jennifer C; Champagne, Catherine M; Gunturk, Bahadir K; Bray, George A

2012-04-01

Two studies are reported; a pilot study to demonstrate feasibility followed by a larger validity study. Study 1's objective was to test the effect of two ecological momentary assessment (EMA) approaches that varied in intensity on the validity/accuracy of estimating energy intake (EI) with the Remote Food Photography Method (RFPM) over 6 days in free-living conditions. When using the RFPM, Smartphones are used to capture images of food selection and plate waste and to send the images to a server for food intake estimation. Consistent with EMA, prompts are sent to the Smartphones reminding participants to capture food images. During Study 1, EI estimated with the RFPM and the gold standard, doubly labeled water (DLW), were compared. Participants were assigned to receive Standard EMA Prompts (n = 24) or Customized Prompts (n = 16) (the latter received more reminders delivered at personalized meal times). The RFPM differed significantly from DLW at estimating EI when Standard (mean ± s.d. = -895 ± 770 kcal/day, P < 0.0001), but not Customized Prompts (-270 ± 748 kcal/day, P = 0.22) were used. Error (EI from the RFPM minus that from DLW) was significantly smaller with Customized vs. Standard Prompts. The objectives of Study 2 included testing the RFPM's ability to accurately estimate EI in free-living adults (N = 50) over 6 days, and energy and nutrient intake in laboratory-based meals. The RFPM did not differ significantly from DLW at estimating free-living EI (-152 ± 694 kcal/day, P = 0.16). During laboratory-based meals, estimating energy and macronutrient intake with the RFPM did not differ significantly compared to directly weighed intake.

Validity of the Remote Food Photography Method (RFPM) for estimating energy and nutrient intake in near real-time

PubMed Central

Martin, C. K.; Correa, J. B.; Han, H.; Allen, H. R.; Rood, J.; Champagne, C. M.; Gunturk, B. K.; Bray, G. A.

2014-01-01

Two studies are reported; a pilot study to demonstrate feasibility followed by a larger validity study. Study 1’s objective was to test the effect of two ecological momentary assessment (EMA) approaches that varied in intensity on the validity/accuracy of estimating energy intake with the Remote Food Photography Method (RFPM) over six days in free-living conditions. When using the RFPM, Smartphones are used to capture images of food selection and plate waste and to send the images to a server for food intake estimation. Consistent with EMA, prompts are sent to the Smartphones reminding participants to capture food images. During Study 1, energy intake estimated with the RFPM and the gold standard, doubly labeled water (DLW), were compared. Participants were assigned to receive Standard EMA Prompts (n=24) or Customized Prompts (n=16) (the latter received more reminders delivered at personalized meal times). The RFPM differed significantly from DLW at estimating energy intake when Standard (mean±SD = −895±770 kcal/day, p<.0001), but not Customized Prompts (−270±748 kcal/day, p=.22) were used. Error (energy intake from the RFPM minus that from DLW) was significantly smaller with Customized vs. Standard Prompts. The objectives of Study 2 included testing the RFPM’s ability to accurately estimate energy intake in free-living adults (N=50) over six days, and energy and nutrient intake in laboratory-based meals. The RFPM did not differ significantly from DLW at estimating free-living energy intake (−152±694 kcal/day, p=0.16). During laboratory-based meals, estimating energy and macronutrient intake with the RFPM did not differ significantly compared to directly weighed intake. PMID:22134199

The impact of new partial AUC parameters for evaluating the bioequivalence of prolonged-release formulations.

PubMed

Boily, Michaël; Dussault, Catherine; Massicotte, Julie; Guibord, Pascal; Lefebvre, Marc

2015-01-23

To demonstrate bioequivalence (BE) between two prolonged-release (PR) drug formulations, single dose studies under fasting and fed state as well as at least one steady-state study are currently required by the European Medicines Agency (EMA). Recently, however, there have been debates regarding the relevance of steady-state studies. New requirements in single-dose investigations have also been suggested by the EMA to address the absence of a parameter that can adequately assess the equivalence of the shape of the curves. In the draft guideline issued in 2013, new partial area under the curve (pAUC) pharmacokinetic (PK) parameters were introduced to that effect. In light of these potential changes, there is a need of supportive clinical evidence to evaluate the impact of pAUCs on the evaluation of BE between PR formulations. In this retrospective analysis, it was investigated whether the newly defined parameters were associated with an increase in discriminatory ability or a change in variability compared to the conventional PK parameters. Among the single dose studies that met the requirements already in place, 20% were found unable to meet the EMA's new requirements in regards to the pAUC PK parameters. When pairing fasting and fed studies for a same formulation, the failure rate increased to 40%. In some cases, due to the high variability of these parameters, an increase of the sample size would be required to prove BE. In other cases however, the pAUC parameters demonstrated a robust ability to detect differences between the shapes of the curves of PR formulations. The present analysis should help to better understand the impact of the upcoming changes in European regulations on PR formulations and in the design of future BE studies. Copyright © 2014 Elsevier B.V. All rights reserved.

EU marketing authorization review of orphan and non-orphan drugs does not differ.

PubMed

Putzeist, M; Mantel-Teeuwisse, A K; Llinares, J; Gispen-De Wied, C C; Hoes, A W; Leufkens, H G M

2013-10-01

Marketing authorization application dossiers of 17 orphan drugs (ODs) and 51 non-ODs evaluated by the European Medicines Agency (EMA) in the period 2009-2010 were compared. We aimed to identify whether any differences existed between ODs and non-ODs in number and type of deficits brought forward during the EMA review, regarding the clinical development plan, clinical outcome and medical need and studied whether these deficits were similarly associated with marketing approval in the EU. In 71% of the ODs dossiers and 65% of the non-ODs dossiers marketing approval was granted. Differences in deficits were found, but similarities in the way ODs and non-ODs were reviewed and marketing approval decisions were taken, underline that regulatory standards are equally high. Copyright © 2013 Elsevier Ltd. All rights reserved.

An Evaluation of Material Properties Using EMA and FEM

NASA Astrophysics Data System (ADS)

Ďuriš, Rastislav; Labašová, Eva

2016-12-01

The main goal of the paper is the determination of material properties from experimentally measured natural frequencies. A combination of two approaches to structural dynamics testing was applied: the experimental measurements of natural frequencies were performed by Experimental Modal Analysis (EMA) and the numerical simulations, were carried out by Finite Element Analysis (FEA). The optimization methods were used to determine the values of density and elasticity modulus of a specimen based on the experimental results.

Infanrix hexa and sudden death: a review of the periodic safety update reports submitted to the European Medicines Agency.

PubMed

Puliyel, Jacob; Sathyamala, C

2018-01-01

There have been a number of spontaneous reports of sudden unexpected death soon after the administration of Infanrix hexa (combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliomyelitis and Haemophilus influenza type B vaccine). The manufacturer, GlaxoSmithKline (GSK), submits confidential periodic safety update reports (PSURs) on Infanrix hexa to the European Medicines Agency (EMA). The latest is the PSUR 19. Each PSUR contains an analysis of observed/expected sudden deaths, which shows that the number of observed deaths soon after immunisation is lower than that expected by chance. This commentary focuses on that aspect of the PSUR which has a bearing on policy decisions. We analysed the data provided in the PSURs. It is apparent that the deaths acknowledged in the PSUR 16 were deleted from the PSUR 19. The number of observed deaths soon after vaccination among children older than one year was significantly higher than that expected by chance once the deleted deaths were restored and included in the analysis. The manufacturer must explain the figures that have been submitted to the regulatory authorities. The procedures undertaken by the EMA to evaluate the manufacturer's claims in the PSUR need to be reviewed. The Drugs Controller General of India nearly automatically accepts drugs and vaccines approved by the EMA. There is a need to reappraise the reliance on due diligence by the EMA.

Electromechanical actuators affected by multiple failures: Prognostic method based on spectral analysis techniques

NASA Astrophysics Data System (ADS)

Belmonte, D.; Vedova, M. D. L. Dalla; Ferro, C.; Maggiore, P.

2017-06-01

The proposal of prognostic algorithms able to identify precursors of incipient failures of primary flight command electromechanical actuators (EMA) is beneficial for the anticipation of the incoming failure: an early and correct interpretation of the failure degradation pattern, in fact, can trig an early alert of the maintenance crew, who can properly schedule the servomechanism replacement. An innovative prognostic model-based approach, able to recognize the EMA progressive degradations before his anomalous behaviors become critical, is proposed: the Fault Detection and Identification (FDI) of the considered incipient failures is performed analyzing proper system operational parameters, able to put in evidence the corresponding degradation path, by means of a numerical algorithm based on spectral analysis techniques. Subsequently, these operational parameters will be correlated with the actual EMA health condition by means of failure maps created by a reference monitoring model-based algorithm. In this work, the proposed method has been tested in case of EMA affected by combined progressive failures: in particular, partial stator single phase turn to turn short-circuit and rotor static eccentricity are considered. In order to evaluate the prognostic method, a numerical test-bench has been conceived. Results show that the method exhibit adequate robustness and a high degree of confidence in the ability to early identify an eventual malfunctioning, minimizing the risk of fake alarms or unannounced failures.

Job stress, social support, and prevalence of insomnia in a population of Japanese daytime workers.

PubMed

Nakata, Akinori; Haratani, Takashi; Takahashi, Masaya; Kawakami, Norito; Arito, Heihachiro; Kobayashi, Fumio; Araki, Shunichi

2004-10-01

To clarify the relationship between perceived job stress, social support and prevalence of insomnia in Japanese daytime workers, 1161 male white-collar employees of an electric equipment manufacturing company (age, 23-60 years, mean age of 37.0) were surveyed by means of a mailed questionnaire. Perceived job stress was evaluated with the Japanese version of the generic NIOSH job stress questionnaire. Insomnia was diagnosed if workers had at least 1 of 3 types of symptoms on an almost nightly basis. The symptoms were (1) taking more than 30 min to fall asleep (Difficulty Initiating Sleep, DIS), (2) difficulty in maintaining sleep (DMS), or (3) early morning awakening (EMA). The overall prevalence of insomnia was 23.6% and the prevalences of the three subtypes were 11.3% for DIS, 14.2% for DMS, and 1.9% for EMA. Workers with high intragroup conflict (OR 1.6), high job dissatisfaction (OR 1.5), and high symptoms of depression (OR 2.0) (CES-D > 16) had a significantly increased risk for insomnia after adjusting for multiple confounding factors. Low employment opportunities, physical environment and low coworker support also were weakly associated with risk for insomnia among workers. Furthermore, high depressive symptoms significantly increased the risk of DIS (OR 2.4). Therefore in white-collar male daytime workers, psychological job stress factors such as interpersonal conflicts with fellow employees, job satisfaction, and social support were independently associated with a modestly increased risk of insomnia that included three different subtypes that were considered to be defining for the disorder.

An electromechanical actuation system for an expendable launch vehicle

NASA Technical Reports Server (NTRS)

Burrows, Linda M.; Roth, Mary Ellen

1992-01-01

A major effort at the NASA Lewis Research Center in recent years has been to develop electro-mechanical actuators (EMA's) to replace the hydraulic systems used for thrust vector control (TVC) on launch vehicles. This is an attempt ot overcome the inherent inefficiencies and costs associated with the existing hydraulic structures. General Dynamics Space Systems Division, under contract to NASA Lewis, is developing 18.6 kW (25 hp), 29.8 kW (40 hp), and 52.2 kW (70 hp) peak EMA systems to meet the power demands for TVC on a family of vehicles developed for the National Launch System. These systems utilize a pulse population modulated converter and field-oriented control scheme to obtain independent control of both the voltage and frequency. These techniques allow an induction motor to be operated at its maximum torque at all times. At NASA Lewis, we are building on this technology to develop our own in-house system capable of meeting the peak power requirements for an expendable launch vehicle (ELV) such as the Atlas. Our EMA will be capable of delivering 22.4 kW (30 hp) peak power with a nominal of 6.0 kW (8 hp). This system differs from the previous ones in two areas: (1) the use of advanced control methods, and (2) the incorporation of built-in-test. The advanced controls are essential for minimizing the controller size, while the built-in-test is necessary to enhance the system reliability and vehicle health monitoring. The ultimate goal of this program is to demonstrate an EMA which will be capable of self-test and easy integration into other projects. This paper will describe the effort underway at NASA Lewis to develop an EMA for an Atlas class ELV. An explanation will be given for each major technology block, and the status of each major technology block and the status of the overall program will be reported.

Strategic Regulatory Evaluation and Endorsement of the Hollow Fiber Tuberculosis System as a Novel Drug Development Tool.

PubMed

Romero, Klaus; Clay, Robert; Hanna, Debra

2015-08-15

The first nonclinical drug development tool (DDT) advanced by the Critical Path to TB Drug Regimens (CPTR) Initiative through a regulatory review process has been endorsed by leading global regulatory authorities. DDTs with demonstrated predictive accuracy for clinical and microbiological outcomes are needed to support decision making. Regulatory endorsement of these DDTs is critical for drug developers, as it promotes confidence in their use in Investigational New Drug and New Drug Application filings. The in vitro hollow fiber system model of tuberculosis (HFS-TB) is able to recapitulate concentration-time profiles (exposure) observed in patients for single drugs and combinations, by evaluating exposure measures for the ability to kill tuberculosis in different physiologic conditions. Monte Carlo simulations make this quantitative output useful to inform susceptibility breakpoints, dosage, and optimal combination regimens in patients, and to design nonclinical experiments in animal models. The Pre-Clinical and Clinical Sciences Working Group within CPTR executed an evidence-based evaluation of the HFS-TB for predictive accuracy. This extensive effort was enabled through the collaboration of subject matter experts representing the pharmaceutical industry, academia, product development partnerships, and regulatory authorities including the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). A comprehensive analysis plan following the regulatory guidance documents for DDT qualification was developed, followed by individual discussions with the FDA and the EMA. The results from the quantitative analyses were submitted to both agencies, pursuing regulatory DDT endorsement. The EMA Qualification Opinion for the HFS-TB DDT was published 26 January 2015 (available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000319.jsp). © The Author 2015. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Invasive micropapillary carcinoma of urinary bladder: a clinicopathological study.

PubMed

Chatterjee, Debajyoti; Das, Ashim; Radotra, Bishan D

2015-01-01

Micropapillary variant of urothelial carcinoma (MPUC) is a rare but well-recognized tumor of the urinary bladder. Tumors with micropapillary areas accompanying conventional urothelial carcinoma are more aggressive compared to conventional urothelial carcinoma and show variable keratin 7, keratin 20 and human epidermal growth factor receptor 2 (Her 2)neu expression. The aim of the study was to analyze the clinical, morphological and immunohistochemical profile of MPUC. Transurethral resection of bladder tumor (TURBT) chips of seven cases of invasive MPUC with subsequent cystoprostatectomy specimens of five patients was reviewed. Epithelial membrane antigen (EMA), Keratin 7, Keratin 20, and Her 2 immunohistochemistry were performed in all cases. Follow-up information was available for all patients (2-36 months). All seven patients were male, and their ages ranged from 50 to 62 years. All cases presented with hematuria. The micropapillary pattern was seen in 20-95% of the tumor. All cases showed extensive lymphatic emboli with detrusor muscle invasion. Lymph node metastasis was present in all cases undergoing cystoprostatectomy except one. Keratin 7 and abluminal pattern of EMA positivity were seen in all cases. Keratin 20 was positive in five cases (71%), and Her 2neu positivity was seen in four cases. Three patients died 2, 3, and 6 months after initial diagnosis, among which two were Her 2 positive and one was Her 2 negative. There was no clear prognostic significance of Her 2 positivity. (1) MPUC is a rare but highly aggressive tumor. (2) Micropapillary is usually the predominant pattern. (3) Keratin 7 is expressed universally, whereas Keratin 20 expression is variable. (4) Her 2 expression has no clear influence on the survival.

Accuracy in Diagnosis of Celiac Disease Without Biopsies in Clinical Practice.

PubMed

Werkstetter, Katharina Julia; Korponay-Szabó, Ilma Rita; Popp, Alina; Villanacci, Vincenzo; Salemme, Marianna; Heilig, Gabriele; Lillevang, Søren Thue; Mearin, Maria Luisa; Ribes-Koninckx, Carmen; Thomas, Adrian; Troncone, Riccardo; Filipiak, Birgit; Mäki, Markku; Gyimesi, Judit; Najafi, Mehri; Dolinšek, Jernej; Dydensborg Sander, Stine; Auricchio, Renata; Papadopoulou, Alexandra; Vécsei, Andreas; Szitanyi, Peter; Donat, Ester; Nenna, Rafaella; Alliet, Philippe; Penagini, Francesca; Garnier-Lengliné, Hélène; Castillejo, Gemma; Kurppa, Kalle; Shamir, Raanan; Hauer, Almuthe Christine; Smets, Françoise; Corujeira, Susana; van Winckel, Myriam; Buderus, Stefan; Chong, Sonny; Husby, Steffen; Koletzko, Sibylle

2017-10-01

The guidelines of the European Society of Pediatric Gastroenterology, Hepatology, and Nutrition allow for diagnosis of celiac disease without biopsies in children with symptoms and levels of immunoglobulin A against tissue-transglutaminase (TGA-IgA) 10-fold or more the upper limit of normal (ULN), confirmed by detection of endomysium antibodies (EMA) and positivity for HLA-DQ2/DQ8. We performed a large, international prospective study to validate this approach. We collected data from consecutive pediatric patients (18 years or younger) on a gluten-containing diet who tested positive for TGA-IgA from November 2011 through May 2014, seen at 33 pediatric gastroenterology units in 21 countries. Local centers recorded symptoms; measurements of total IgA, TGA, and EMA; and histopathology findings from duodenal biopsies. Children were considered to have malabsorption if they had chronic diarrhea, weight loss (or insufficient gain), growth failure, or anemia. We directly compared central findings from 16 antibody tests (8 for TGA-IgA, 1 for TGA-IgG, 6 for IgG against deamidated gliadin peptides, and 1 for EMA, from 5 different manufacturers), 2 HLA-DQ2/DQ8 tests from 2 manufacturers, and histopathology findings from the reference pathologist. Final diagnoses were based on local and central results. If all local and central results were concordant for celiac disease, cases were classified as proven celiac disease. Patients with only a low level of TGA-IgA (threefold or less the ULN) but no other results indicating celiac disease were classified as no celiac disease. Central histo-morphometry analyses were performed on all other biopsies and cases were carefully reviewed in a blinded manner. Inconclusive cases were regarded as not having celiac disease for calculation of diagnostic accuracy. The primary aim was to determine whether the nonbiopsy approach identifies children with celiac disease with a positive predictive value (PPV) above 99% in clinical practice. Secondary aims included comparing performance of different serological tests and to determine whether the suggested criteria can be simplified. Of 803 children recruited for the study, 96 were excluded due to incomplete data, low level of IgA, or poor-quality biopsies. In the remaining 707 children (65.1% girls; median age, 6.2 years), 645 were diagnosed with celiac disease, 46 were found not to have celiac disease, and 16 had inconclusive results. Findings from local laboratories of TGA-IgA 10-fold or more the ULN, a positive result from the test for EMA, and any symptom identified children with celiac disease (n = 399) with a PPV of 99.75 (95% confidence interval [CI], 98.61-99.99); the PPV was 100.00 (95% CI, 98.68-100.00) when only malabsorption symptoms were used instead of any symptom (n = 278). Inclusion of HLA analyses did not increase accuracy. Findings from central laboratories differed greatly for patients with lower levels of antibodies, but when levels of TGA-IgA were 10-fold or more the ULN, PPVs ranged from 99.63 (95% CI, 98.67-99.96) to 100.00 (95% CI, 99.23-100.00). Children can be accurately diagnosed with celiac disease without biopsy analysis. Diagnosis based on level of TGA-IgA 10-fold or more the ULN, a positive result from the EMA tests in a second blood sample, and the presence of at least 1 symptom could avoid risks and costs of endoscopy for more than half the children with celiac disease worldwide. HLA analysis is not required for accurate diagnosis. Clinical Trial Registration no: DRKS00003555. Copyright © 2017 AGA Institute. Published by Elsevier Inc. All rights reserved.

An Analysis of Acquisition Strategies for the Turkish Armed Forces.

DTIC Science & Technology

1987-12-01

under Daimler-Benz license. Today, it is a leader (77 percent of market share in Turkey) in long distance passenger buses. Otomarsan is an active...designed to help Turkey continue her policy of movement toward a free market economy. This fund is administered by the Department of State. and has...DTSI. The DD Crm 1513. Letter of’OlTer and Acceptance (LOA) is the primar: document used to * :nvcv t> ~ ema:ed FIS case price to the foreign government

Application of ecological momentary assessment in workplace health evaluation.

PubMed

Engelen, Lina; Chau, Josephine Y; Burks-Young, Sarah; Bauman, Adrian

2016-02-01

Issue addressed Ecological momentary assessment (EMA) involves repeated sampling of current behaviours and experiences in real-time at random intervals. EMA is an innovative measurement method for program evaluation, using mobile technology (e.g. smartphones) to collect valid contextual health promotion data with good compliance. The present study examined the feasibility of using EMA for measuring workplace health outcomes. Methods Twenty-two office-based adults were prompted at four random times per work-day during a 5-day period to respond to a short survey via a smartphone application. The prompting stopped when participants had either responded 12 times or the 5-day period had ended. The questions pertained to posture, task currently being undertaken, social interactions, musculoskeletal issues, mood, and perceptions of engagement and creativity. Results In total 156 responses were collected. Nine participants completed all 12 surveys; the average completion rate was 58% (7/12). The average completion time was initially 50s and reduced to 24s during the later surveys. On average the participants were sitting and standing in 79% and 14% of survey instances, respectively. The participants reported they were working alone at their desks in 68% of instances. Reported productivity and stress were on average 6 and 3 out of 10, respectively, but varied up to 6-8 points within one person, hence the method appears sensitive to temporal variations in perceptions and mood. Conclusion Given the rich real-time data, minimal participant burden and use of readily available technology, EMA has substantial potential in workplace health promotion evaluation through the measurement of participants' well being, activities, and behaviour change. So what? An in-the-moment method using readily available mobile technology to assess participants' perceptions, mood and activity that provides rich information with minimal participant burden is a promising way to evaluate future health promotion programs.

Hair cortisol and self-reported stress in healthy, working adults.

PubMed

Gidlow, Christopher J; Randall, Jason; Gillman, Jamie; Silk, Steven; Jones, Marc V

2016-01-01

Chronic stress can be important in the pathology of chronic disease. Hair cortisol concentrations (HCC) are proposed to reflect long term cortisol secretion from exposure to stress. To date, inconsistencies in the relationship between HCC and self-reported stress have been attributed to variation and limitations of perceived stress measurement. We report data from employees of two large public sector worksites (n=132). Socio-demographic, health, lifestyle, perceived stress scale (PSS), and work-related effort reward imbalance (ERI) were collected at baseline. Participants were asked to respond to mobile text messages every two days, asking them to report current stress levels (Ecological momentary assessment, EMA), and mean stress was determined overall, during work hours, and out of work hours. At 12 weeks, the appraisal of stressful life events scale (ALES) was completed and 3 cm scalp hair samples were taken, from which HCC was determined (to reflect cortisol secretion over the past 12 weeks). Mean response rate to EMA was 81.9 ± 14.9%. Associations between HCC and the various self-reported stress measures (adjusted for use of hair dye) were weak (all<.3). We observed significant associations with HCC for EMA measured stress responses received out of work hours (ρ=.196, p=.013) and ALES Loss subscale (ρ=.241, p=.003), and two individual items from ERI (relating to future work situation). In regression analysis adjusting for other possible confounders, only the HCC-ALES Loss association remained significant (p=.011). Overall, our study confirms that EMA provides a useful measurement tool that can gather perceived stress measures in real-time. But, there was no relationship between self-reported stress collected in this way, and HCC. The modest association between HCC and stress appraisal does however, provide some evidence for the role of cognitive processes in chronic stress. Copyright © 2015 Elsevier Ltd. All rights reserved.

Kinematic investigation of lingual movement in words of increasing length in acquired apraxia of speech.

PubMed

Bartle-Meyer, Carly J; Goozee, Justine V; Murdoch, Bruce E

2009-02-01

The current study aimed to use electromagnetic articulography (EMA) to investigate the effect of increasing word length on lingual kinematics in acquired apraxia of speech (AOS). Tongue-tip and tongue-back movement was recorded for five speakers with AOS and a concomitant aphasia (mean age = 53.6 years; SD = 12.60) during target consonant production (i.e. /t, s, k/ singletons; /kl, sk/ clusters), for one and two syllable stimuli. The results obtained for each of the participants with AOS were individually compared to those obtained by a control group (n = 12; mean age = 52.08 years; SD = 12.52). Results indicated that the participants with AOS exhibited longer movement durations and, in some instances, larger tongue movements during consonant singletons and consonant cluster constituents embedded within mono- and multisyllabic utterances. Despite this, two participants with AOS exhibited a word length effect that was comparable with the control speakers, and possibly indicative of an intact phonological system.

Tracking Young Adults' Attitudes Toward Tobacco Marketing Using Ecological Momentary Assessment (EMA).

PubMed

Roberts, Megan E; Lu, Bo; Browning, Christopher R; Ferketich, Amy K

2017-07-29

Decades of research demonstrate the pernicious effects of targeted cigarette marketing on young people. Now, with tobacco marketing shifting toward greater incorporation of alternative products, it is critical to identify current attitudes toward the new landscape of tobacco advertisements. The purpose of this study was to understand the present landscape of tobacco marketing to which young adults are exposed, and to assess how they respond to it. During 2015-2016, we used ecological momentary assessment (EMA), in which 44 young adults (aged 18-28) carried smartphones equipped with a survey app. Seventy-seven percent were ever-users of tobacco and 29.5% were intermittent users of tobacco (someday users of cigarettes and/or those who used another tobacco product >5 times within the past year). For ten days, participants were prompted at three random times/day to complete a brief survey about their exposures and responses to tobacco-related advertising. Analyses used t-test and multilevel modeling. Intermittent users reported greater exposure than non-intermittent users to tobacco advertising. Further, both intermittent and ever-users reported more positive attitudes toward the tobacco advertising. Of the tobacco advertisements reported, 22% were for products unregulated by the FDA at the time of data collection. Conclusions/Importance: These findings indicate that young adults, and especially young adults who use tobacco, are exposed to a fair amount of tobacco advertising on a weekly basis. As the tobacco users in our sample were largely experimental and occasional users, these marketing exposures could put young adults at risk for progression toward regular use.

The European Medicines Agency experience with biomarker qualification.

PubMed

Manolis, Efthymios; Koch, Armin; Deforce, Dieter; Vamvakas, Spiros

2015-01-01

Since the launch of the qualification process in 2009, the CHMP reviewed/is reviewing 48 requests for qualification advice or opinion (as of Sept 2013) related to biomarkers (BM) or other novel drug development tools (e.g. patient reported outcome measures, modeling, and statistical methods). The qualification opinions are available on the EMA website (Qualification of novel methodologies for medicine development, http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000319.jsp&mid=WC0b01ac0580022bb0#section2 , 2013). Also there is a trend of increasing numbers of qualification requests to CHMP, indicative of the pace that targeted drug development and personalized medicine is gaining and the need to bring the new tools from research to drug development and clinical use. This chapter will focus on the regulatory experience gained so far from the CHMP qualification procedure. Basic qualification principles will be presented. Through qualification examples, we will elaborate on common grounds and divergences between the different stakeholders.

Status of Emergency Contraceptives in Europe One Year after the European Medicines Agency's Recommendation to Switch Ulipristal Acetate to Non-Prescription Status.

PubMed

Italia, Salvatore; Brand, Helmut

2016-01-01

In November 2014, the European Medicines Agency (EMA) recommended switching the emergency contraceptive (EMC) ulipristal acetate to non-prescription status. This study's objective is to assess the current legal status of the two EMCs ulipristal acetate and levonorgestrel in Europe and to report on the development of sales figures for EMCs since they were made freely available. Health authorities were contacted in autumn 2015 and asked about the current status of EMCs and whether the sales figures had changed after a switch to non-prescription status. Additionally, data on consumption were collected in 18 German community pharmacies. As of November 2015, most countries in the European Union (EU) have followed the EMA recommendation. Hungary kept the prescription-only status. In Malta, EMC drugs are not authorized. Germany and Croatia switched levonorgestrel to non-prescription status as well. Of the EU candidate and European Free Trade Association countries, ulipristal acetate is available without prescription in Norway and Bosnia and Herzegovina only. Several countries reported an increase in EMC sales since the switch. An EMA recommendation can strongly contribute to the harmonization of a drug's legal status in the EU. In most European countries, ulipristal acetate and/or levonorgestrel are now freely available. © 2016 The Author(s) Published by S. Karger AG, Basel.

Personality-based subtypes of anorexia nervosa: examining validity and utility using baseline clinical variables and ecological momentary assessment.

PubMed

Lavender, Jason M; Wonderlich, Stephen A; Crosby, Ross D; Engel, Scott G; Mitchell, James E; Crow, Scott J; Peterson, Carol B; Le Grange, Daniel

2013-08-01

This study sought to empirically derive and validate clinically relevant personality-based subtypes of anorexia nervosa (AN). Women (N = 116) with full or subthreshold AN completed baseline measures of personality, clinical variables, and eating disorder (ED) symptoms, followed by two weeks of ecological momentary assessment (EMA). A latent profile analysis was conducted to identify personality subtypes, which were compared on baseline clinical variables and EMA variables. The best-fitting model supported three subtypes: underregulated, overregulated, and low psychopathology. The underregulated subtype (characterized by high Stimulus Seeking, Self-Harm, and Oppositionality) displayed greater baseline ED symptoms, as well as lower positive affect and greater negative affect, self-discrepancy, and binge eating in the natural environment. The overregulated subtype (characterized by high Compulsivity and low Stimulus Seeking) was more likely to have a lifetime obsessive-compulsive disorder diagnosis and exhibited greater perfectionism; levels of negative affect, positive affect, and self-discrepancy in this group were intermediate between the other subtypes. The low psychopathology subtype (characterized by normative personality) displayed the lowest levels of baseline ED symptoms, co-occurring disorders, and ED behaviors measured via EMA. Findings support the validity of these personality-based subtypes, suggesting the potential utility of addressing within-diagnosis heterogeneity in the treatment of AN. Copyright © 2013 Elsevier Ltd. All rights reserved.

Pilot feasibility of an mHealth system for conducting ecological momentary assessment of mood-related symptoms following traumatic brain injury.

PubMed

Juengst, Shannon B; Graham, Kristin M; Pulantara, I Wayan; McCue, Michael; Whyte, Ellen M; Dicianno, Brad E; Parmanto, Bambang; Arenth, Patricia M; Skidmore, Elizabeth R D; Wagner, Amy K

2015-01-01

This study assessed pilot feasibility and validity of a mobile health (mHealth) system for tracking mood-related symptoms after traumatic brain injury (TBI). A prospective, repeated measures design was used to assess compliance with daily ecological momentary assessments (EMA) conducted via a smartphone application over an 8-week period. An mHealth system was developed specifically for individuals with TBI and utilized previously validated tools for depressive and anxiety symptoms (Patient Health Questionnaire-9, Generalized Anxiety Disorder-7). Feasibility was assessed in 20 community-dwelling adults with TBI via an assessment of compliance, satisfaction and usability of the smartphone applications. The authors also developed and implemented a clinical patient safety management mechanism for those endorsing suicidality. Participants correctly completed 73.4% of all scheduled assessments, demonstrating good compliance. Daily assessments took <2 minutes to complete. Participants reported high satisfaction with smartphone applications (6.3 of 7) and found them easy to use (6.2 of 7). Comparison of assessments obtained via telephone-based interview and EMA demonstrated high correlations (r = 0.81-0.97), supporting the validity of conducting these assessments via smartphone application in this population. EMA conducted via smartphone demonstrates initial feasibility among adults with TBI and presents numerous opportunities for long-term monitoring of mood-related symptoms in real-world settings.

Ecological momentary assessment in a behavioral drinking moderation training program.

PubMed

Collins, R L; Morsheimer, E T; Shiffman, S; Paty, J A; Gnys, M; Papandonatos, G D

1998-08-01

We assessed predictors of self-reported excessive drinking (> 5 drinks) in a sample of heavy drinkers. Participants were randomly assigned to moderation training or a waiting-list control condition. They were trained in ecological momentary assessment (EMA) involving self-monitoring of drinking and other variables on a small hand-held computer, the electronic diary (ED). During the 8-week study, participants were compliant in their use of the ED for both random prompts and the entry of data related to specific drinking episodes. Generalized estimating equations were used to fit models involving predictors related to past history of drinking, aspects of the training program, drinking restraint, and episode-specific mood. The models indicated robust predictors of decreased and increased drinking. Our results suggest that EMA is a useful methodology for assessing drinking and related behaviors.

[The EU Portal: Implementation, importance, and features].

PubMed

von Aschen, Harald; Krafft, Hartmut

2017-08-01

The European Medicines Agency (EMA) is developing a web-based EU portal with a database "at Union level as a single entry point for the submission of data and information relating to clinical trials in accordance with" the new EU regulation No. 536/2014. The specifications are mostly published, but some documents are still missing. Because the project is integrated and has dependencies on other projects, this could result in other specification upgrades. The IT solution is under ongoing development until project completion in quarter III of 2019. The EU Portal and the database will be audited. If the audit is successful, the new regulation will come into force in October 2018. The use of the EU Portal will then be mandatory with some transition rules. The software development of the portal is restricted to the regulation and the derived requirements. It is not possible to implement any national requirements. We describe in this paper the current key functionalities of the portal and try to derive requirements for a national IT system.On 16.06.2017 the EMA Management Board announced that the development of the new portal has been delayed and it is foreseen that the new regulation can come into effect in 2019 at the earliest. The press release can be found here: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2017/06/news_detail_002764.jsp%26mid=WC0b01ac058004d5c1 (accessed: 12.07.2017).

Design of power electronics for TVC EMA systems

NASA Technical Reports Server (NTRS)

Nelms, R. Mark

1993-01-01

The Composite Development Division of the Propulsion Laboratory at Marshall Space Flight Center (MSFC) is currently developing a class of electromechanical actuators (EMA's) for use in space transportation applications such as thrust vector control (TVC) and propellant control valves (PCV). These high power servomechanisms will require rugged, reliable, and compact power electronic modules capable of modulating several hundred amperes of current at up to 270 volts. MSFC has selected the brushless dc motor for implementation in EMA's. This report presents the results of an investigation into the applicability of two new technologies, MOS-controlled thyristors (MCT's) and pulse density modulation (PDM), to the control of brushless dc motors in EMA systems. MCT's are new power semiconductor devices, which combine the high voltage and current capabilities of conventional thyristors and the low gate drive requirements of metal oxide semiconductor field effect transistors (MOSFET's). The commanded signals in a PDM system are synthesized using a series of sinusoidal pulses instead of a series of square pulses as in a pulse width modulation (PWM) system. A resonant dc link inverter is employed to generate the sinusoidal pulses in the PDM system. This inverter permits zero-voltage switching of all semiconductors which reduces switching losses and switching stresses. The objectives of this project are to develop and validate an analytical model of the MCT device when used in high power motor control applications and to design, fabricate, and test a prototype electronic circuit employing both MCT and PDM technology for controlling a brushless dc motor.

Phenomena of Foamed Concrete under Rolling of Aircraft Wheels

NASA Astrophysics Data System (ADS)

Jiang, Chun-shui; Yao, Hong-yu; Xiao, Xian-bo; Kong, Xiang-jun; Shi, Ya-jie

2014-04-01

Engineered Material Arresting System (EMAS) is an effective technique to reduce hazards associated with aircraft overrunning runway. In order to ascertain phenomena of the foamed concrete used for EMAS under rolling of aircraft wheel, a specially designed experimental setup was built which employed Boeing 737 aircraft wheels bearing actual vertical loads to roll through the foamed concrete. A number of experiments were conducted upon this setup. It is discovered that the wheel rolls the concrete in a pure rolling manner and crushes the concrete downwards, instead of crushing it forward, as long as the concrete is not higher than the wheel axle. The concrete is compressed into powder in-situ by the wheel and then is brought to bottom of the wheel. The powder under the wheel is loose and thus is not able to sustain wheel braking. It is also found that after being rolled by the wheel the concrete exhibits either of two states, i.e. either 'crushed through' whole thickness of the concrete or 'crushed halfway', depending on combination of strength of the concrete, thickness of the concrete, vertical load the wheel carries, tire dimension and tire pressure. A new EMAS design concept is developed that if an EMAS design results in the 'crushed through' state for the main gears while the 'crushed halfway' state for the nose gear, the arresting bed would be optimal to accommodate the large difference in strength between the nose gear and the main gear of an aircraft.

[Concepts for the regulation of mixtures of toxic pollutants in environmental hygiene].

PubMed

Csicsaky, M J

1998-06-01

In view of the increasing accumulation of large-scale livestock production facilities in the western parts of Lower Saxony the question rises how ecology and economy can be conciliated and how the protection of human health can be assured. Based on existing legislation this is hard to achieve because of the weak legal position of the administration when trying to prohibit the further expansion of livestock production as opposed to the strong legal position of owners and investors. Presently there is no agreement within the scientific community on safe limits for airborne pathogens and it is quite obvious that thresholds for peak concentrations do not solve the problem of background level exposures. Apart from the unsatisfactory current practise to licence farm animal units in the outskirts of existing villages only, in future the introduction of the EC Environmental Management and Auditing Scheme (EMAS) in animal production may improve the situation. This management system is intended to permanently reduce the environmental impact of a production site and implements the ALARA-PRINCIPLE (as low as reasonably achievable) which is known from protection measures against radiation. As the implementation of the EMAS so far works only on a voluntary basis, an incentive is needed. If dealers and consumers give preference to products from producers having adopted the EMAS, this would be a very efficient incentive. Before this could be put into practise, however, the EMAS criteria originally designed for industrial production sites will have to be adapted to the special conditions of animal production.

MovingU: A prospective cohort study to understand behavioural and environmental contexts influencing physical activity during the transition into emerging adulthood.

PubMed

Kwan, Matthew Y W; Bedard, Chloe; King-Dowling, Sara; Wellman, Sarah; Cairney, John

2016-08-05

Children and youth are often considered the most active segment of the population, however, research indicates that physical activity (PA) tends to peak during the adolescent years, declining thereafter with age. In particular, the acute transition out of high school is a period for which individuals appear to be at high-risk for becoming less active. Relatively few studies have investigated the factors influencing the changes in PA during this transition period. Therefore the purpose of the MovingU study is to gain a comprehensive understanding of the behavioural patterns and the socio-ecological factors related to the changes in PA during the transition out of high school. MovingU is comprised of two phases. Phase I is a prospective cohort design and aims to follow 120 students in their last year of high school through to their first year out of high school. Students will be asked to complete questionnaires measuring various psychosocial and socio-environmental variables (e.g., self-efficacy and distress) four times throughout this transition period. Students will also be given a wrist-worn accelerometer to wear for 7-days at each of the four assessments. Phase II is a cross-sectional study involving 100 first-year university students. Students will be asked to complete the same questionnaire from phase I, wear a wrist-worn accelerometer for 5-days, and complete ecological momentary assessments (EMA) using their smartphones at randomly selected times throughout the day for 5-days. EMA items will capture information regarding contextual and momentary correlates of PA. The MovingU study represents the first to evaluate the social and environmental influences of PA behaviour changes, including the use of intensive real-time data capture strategies during the transition out of high school. This information will be critical in the development of interventions aimed to prevent or attenuate such drastic declines in PA during emerging adulthood period.

Drug development for exceptionally rare metabolic diseases: challenging but not impossible

PubMed Central

2013-01-01

Background We studied to what extent the level of scientific knowledge on exceptionally rare metabolic inherited diseases and their potential orphan medicinal products is associated with sponsors deciding to apply for an orphan designation at the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA). Methods All metabolic diseases with a genetic cause and prevalence of less than 10 patients per 1 million of the population were selected from the ‘Orphanet database of Rare diseases’. The outcome of interest was the application for an orphan designation at FDA or EMA. The level of publicly available knowledge of the disease and drug candidate before an orphan designation application was defined as whether the physiological function corresponding with the pathologic gene and initiation of the pathophysiological pathway was known, whether an appropriate animal study was identified for the disease, whether preclinical proof of concept was ascertained and the availability of data in humans. Other determinants included in the study were metabolic disease class, the prevalence of the disease, prognosis and time of first description of the disease in the literature. Univariate relative risks (RRs) and 95% confidence intervals (CIs) of an orphan designation application were calculated for each of these determinants. In addition, a multivariate Cox regression analysis was conducted (Forward LR). Results In total, 166 rare metabolic genetic diseases were identified and included in the analysis. For only 42 (25%) of the diseases an orphan designation application was submitted at either FDA or EMA before January 2012. The multivariate analysis identified preclinical proof of concept of a potential medicinal product as major knowledge related determinant associated with an orphan designation application (RRadj 3.9, 95% CI 1.9-8.3) and confirmed that prevalence of the disease is also associated with filing an application for an orphan designation (RRadj 2.8, 95% CI 1.4-5.4). Conclusion For only one out of four known exceptionally rare metabolic inherited diseases sponsors applied for an orphan designation at FDA or EMA. These applications were found to be associated with the prevalence of the rare disease and the level of available scientific knowledge on the proof of concept linking possible drug candidates to the disease of interest. PMID:24237580

Efficacy of a Web-Based Guided Recommendation Service for a Curated List of Readily Available Mental Health and Well-Being Mobile Apps for Young People: Randomized Controlled Trial.

PubMed

Bidargaddi, Niranjan; Musiat, Peter; Winsall, Megan; Vogl, Gillian; Blake, Victoria; Quinn, Stephen; Orlowski, Simone; Antezana, Gaston; Schrader, Geoffrey

2017-05-12

Mental disorders are highly prevalent for the people who are aged between 16 and 25 years and can permanently disrupt the development of these individuals. Easily available mobile health (mHealth) apps for mobile phones have great potential for the prevention and early intervention of mental disorders in young adults, but interventions are required that can help individuals to both identify high-quality mobile apps and use them to change health and lifestyle behavior. The study aimed to assess the efficacy of a Web-based self-guided app recommendation service ("The Toolbox") in improving the well-being of young Australians aged between 16 and 25 years. The intervention was developed in collaboration with young adults and consists of a curated list of 46 readily available health and well-being apps, assessed and rated by professionals and young people. Participants are guided by an interactive quiz and subsequently receive recommendations for particular apps to download and use based on their personal goals. The study was a waitlist, parallel-arm, randomized controlled trial. Our primary outcome measure was change in well-being as measured by the Mental Health Continuum-Short Form (MHC-SF). We also employed ecological momentary assessments (EMAs) to track mood, energy, rest, and sleep. Participants were recruited from the general Australian population, via several Web-based and community strategies. The study was conducted through a Web-based platform consisting of a landing Web page and capabilities to administer study measures at different time points. Web-based measurements were self-assessed at baseline and 4 weeks, and EMAs were collected repeatedly at regular weekly intervals or ad hoc when participants interacted with the study platform. Primary outcomes were analyzed using linear mixed-models and intention-to-treat (ITT) analysis. A total of 387 participants completed baseline scores and were randomized into the trial. Results demonstrated no significant effect of "The Toolbox" intervention on participant well-being at 4 weeks compared with the control group (P=.66). There were also no significant differences between the intervention and control groups at 4 weeks on any of the subscales of the MHC-SF (psychological: P=.95, social: P=.42, emotional: P=.95). Repeat engagement with the study platform resulted in a significant difference in mood, energy, rest, and sleep trajectories between intervention and control groups as measured by EMAs (P<.01). This was the first study to assess the effectiveness of a Web-based well-being intervention in a sample of young adults. The design of the intervention utilized expert rating of existing apps and end-user codesign approaches resulting in an app recommendation service. Our finding suggests that recommended readily available mental health and well-being apps may not lead to improvements in the well-being of a nonclinical sample of young people, but might halt a decline in mood, energy, rest, and sleep. Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12614000710628; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366145 (Archived by WebCite at http://www.webcitation.org/ 6pWDsnKme). ©Niranjan Bidargaddi, Peter Musiat, Megan Winsall, Gillian Vogl, Victoria Blake, Stephen Quinn, Simone Orlowski, Gaston Antezana, Geoffrey Schrader. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 12.05.2017.

Efficacy of a Web-Based Guided Recommendation Service for a Curated List of Readily Available Mental Health and Well-Being Mobile Apps for Young People: Randomized Controlled Trial

PubMed Central

Musiat, Peter; Winsall, Megan; Vogl, Gillian; Blake, Victoria; Quinn, Stephen; Orlowski, Simone; Antezana, Gaston; Schrader, Geoffrey

2017-01-01

Background Mental disorders are highly prevalent for the people who are aged between 16 and 25 years and can permanently disrupt the development of these individuals. Easily available mobile health (mHealth) apps for mobile phones have great potential for the prevention and early intervention of mental disorders in young adults, but interventions are required that can help individuals to both identify high-quality mobile apps and use them to change health and lifestyle behavior. Objectives The study aimed to assess the efficacy of a Web-based self-guided app recommendation service (“The Toolbox”) in improving the well-being of young Australians aged between 16 and 25 years. The intervention was developed in collaboration with young adults and consists of a curated list of 46 readily available health and well-being apps, assessed and rated by professionals and young people. Participants are guided by an interactive quiz and subsequently receive recommendations for particular apps to download and use based on their personal goals. Methods The study was a waitlist, parallel-arm, randomized controlled trial. Our primary outcome measure was change in well-being as measured by the Mental Health Continuum-Short Form (MHC-SF). We also employed ecological momentary assessments (EMAs) to track mood, energy, rest, and sleep. Participants were recruited from the general Australian population, via several Web-based and community strategies. The study was conducted through a Web-based platform consisting of a landing Web page and capabilities to administer study measures at different time points. Web-based measurements were self-assessed at baseline and 4 weeks, and EMAs were collected repeatedly at regular weekly intervals or ad hoc when participants interacted with the study platform. Primary outcomes were analyzed using linear mixed-models and intention-to-treat (ITT) analysis. Results A total of 387 participants completed baseline scores and were randomized into the trial. Results demonstrated no significant effect of “The Toolbox” intervention on participant well-being at 4 weeks compared with the control group (P=.66). There were also no significant differences between the intervention and control groups at 4 weeks on any of the subscales of the MHC-SF (psychological: P=.95, social: P=.42, emotional: P=.95). Repeat engagement with the study platform resulted in a significant difference in mood, energy, rest, and sleep trajectories between intervention and control groups as measured by EMAs (P<.01). Conclusions This was the first study to assess the effectiveness of a Web-based well-being intervention in a sample of young adults. The design of the intervention utilized expert rating of existing apps and end-user codesign approaches resulting in an app recommendation service. Our finding suggests that recommended readily available mental health and well-being apps may not lead to improvements in the well-being of a nonclinical sample of young people, but might halt a decline in mood, energy, rest, and sleep. Trial Registration Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12614000710628; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366145 (Archived by WebCite at http://www.webcitation.org/ 6pWDsnKme) PMID:28500020

Ecological momentary assessment of the effects of craving and affect on risk for relapse during substance abuse treatment.

PubMed

Moore, Todd M; Seavey, Amanda; Ritter, Kathrin; McNulty, James K; Gordon, Kristina C; Stuart, Gregory L

2014-06-01

The primary goals of this study were to use ecological momentary assessment (EMA) to examine the extent to which proximal factors (cravings and affect) were temporally associated with relapse, and to assess the role of distal factors (e.g., coping styles) in moderating these associations. We also examined whether using EMA procedures impacted relapse rates. A sample of 100 male (n = 66) and female (n = 34) patients entering outpatient treatment for substance abuse completed a baseline assessment of substance dependence, stress, social support, coping styles, family history of substance abuse, and self-efficacy. Half of the participants were randomly assigned to receive training in using a handheld computer to respond to 3 random prompts each day for 4 months regarding cravings, affect, and substance use. All participants completed 2- and 4-month follow-up assessments of substance use. Results showed that using EMA procedures did not influence relapse rates. Hierarchical linear modeling showed that individuals who reported an increase in cravings on a given prompt were 14 times more likely to report relapse on the subsequent prompt than individuals who did not experience an increase in cravings. In addition, women, older individuals, and individuals who use distraction and disengagement as coping styles were at increased risk for relapse when experiencing an increase in cravings. Individuals who use acceptance as a coping style were at decreased risk for relapse when experiencing an increase in cravings. The study highlights the importance of tailoring treatments to address the needs of particular individuals and risk factors.

Evaluating the influence of at-risk alcohol use on factors associated with smoking cessation: Combining laboratory and ecological momentary assessment.

PubMed

Sells, Joanna R; Waters, Andrew J; MacLean, R Ross

2017-10-01

Most smokers want to quit but most cessation attempts end in failure. Alcohol consumption is associated with smoking behavior and relapse. We examined the associations between severity of drinking and psychological processes during a cessation attempt in the laboratory and during a quit attempt. Smokers (N=209) enrolled in a smoking cessation study were followed from 2 weeks pre-quit through 4 weeks post-quit. Participants scoring 0-7 and 8-15 on the Alcohol Use Disorders Identification Test (AUDIT) were classified as low-risk and high-risk drinkers, respectively. Participants attended one pre-quit laboratory session before which they were required to abstain from smoking and another pre-quit session before which they smoked normally. Craving was assessed in the laboratory with the Questionnaire for Smoking Urges (QSU). A subsample of the participants also completed a 1-week ecological momentary assessment (EMA) study starting on the quit day. During EMA, craving for cigarettes was assessed, and attentional bias was assessed using a smoking Stroop task (n=119). High (vs. low) risk participants reported greater abstinence-induced increases in craving in the laboratory, and also exhibited greater attentional bias on the smoking Stroop task during EMA. High-risk drinkers exhibited a stronger increase in desire to smoke in abstinence and greater attentional bias to smoking cues early in a quit attempt, both of which may motivate continued smoking behaviors. High-risk drinkers may require more intensive or different smoking cessation interventions. Copyright © 2017 Elsevier B.V. All rights reserved.

Enabling Development of Paediatric Medicines in Europe: 10 Years of the EU Paediatric Regulation.

PubMed

Tomasi, Paolo A; Egger, Gunter F; Pallidis, Chrissi; Saint-Raymond, Agnes

2017-12-01

The year 2017 marks the tenth anniversary of entry into force of the Paediatric Regulation in the European Union (EU). This law aimed to stimulate the development of paediatric medicines and provide more information on their use, as a response to the lack of evidence and approval of medicines for children. The European Medicines Agency (EMA) has had a central role in the implementation of the Regulation. Pharmaceutical companies need to submit a paediatric investigation plan (PIP) to the EMA's Paediatric Committee (PDCO) for every new medicine, unless an exemption (waiver) is granted. The plans, which describe the development of drugs for children, must be agreed well in advance of the request for marketing authorization of the medicine. Deferrals of studies can be granted to allow approval in adults before the completion of paediatric studies. Between January 2007 and December 2016, a total of 273 new medicines and 43 additional pharmaceutical forms appropriate for use in children were authorized in the EU, and 950 PIPs were agreed by the EMA. In addition, 486 waivers of the development of a medicine in one or more medical conditions were agreed. The Paediatric Regulation has had a very positive impact on paediatric drug development, as exemplified by a comparison of two periods of 3 years before and after entry into force of the Regulation. We conclude that the Regulation has resulted in more medicines for children and more information on the pediatric use of medicines in the EU being available to clinicians.

Using High-Resolution Airborne Remote Sensing to Study Aerosol Near Clouds

NASA Technical Reports Server (NTRS)

Levy, Robert; Munchak, Leigh; Mattoo, Shana; Marshak, Alexander; Wilcox, Eric; Gao, Lan; Yorks, John; Platnick, Steven

2016-01-01

The horizontal space in between clear and cloudy air is very complex. This so-called twilight zone includes activated aerosols that are not quite clouds, thin cloud fragments that are not easily observable, and dying clouds that have not quite disappeared. This is a huge challenge for satellite remote sensing, specifically for retrieval of aerosol properties. Identifying what is cloud versus what is not cloud is critically important for attributing radiative effects and forcings to aerosols. At the same time, the radiative interactions between clouds and the surrounding media (molecules, surface and aerosols themselves) will contaminate retrieval of aerosol properties, even in clear skies. Most studies on aerosol cloud interactions are relevant to moderate resolution imagery (e.g. 500 m) from sensors such as MODIS. Since standard aerosol retrieval algorithms tend to keep a distance (e.g. 1 km) from the nearest detected cloud, it is impossible to evaluate what happens closer to the cloud. During Studies of Emissions, Atmospheric Composition, Clouds and Climate Coupling by Regional Surveys (SEAC4RS), the NASA ER-2 flew with the enhanced MODIS Airborne Simulator (eMAS), providing MODIS-like spectral observations at high (50 m) spatial resolution. We have applied MODIS-like aerosol retrieval for the eMAS data, providing new detail to characterization of aerosol near clouds. Interpretation and evaluation of these eMAS aerosol retrievals is aided by independent MODIS-like cloud retrievals, as well as profiles from the co-flying Cloud Physics Lidar (CPL). Understanding aerosolcloud retrieval at high resolution will lead to better characterization and interpretation of long-term, global products from lower resolution (e.g.MODIS) satellite retrievals.

Predictive performance of genomic selection methods for carcass traits in Hanwoo beef cattle: impacts of the genetic architecture.

PubMed

Mehrban, Hossein; Lee, Deuk Hwan; Moradi, Mohammad Hossein; IlCho, Chung; Naserkheil, Masoumeh; Ibáñez-Escriche, Noelia

2017-01-04

Hanwoo beef is known for its marbled fat, tenderness, juiciness and characteristic flavor, as well as for its low cholesterol and high omega 3 fatty acid contents. As yet, there has been no comprehensive investigation to estimate genomic selection accuracy for carcass traits in Hanwoo cattle using dense markers. This study aimed at evaluating the accuracy of alternative statistical methods that differed in assumptions about the underlying genetic model for various carcass traits: backfat thickness (BT), carcass weight (CW), eye muscle area (EMA), and marbling score (MS). Accuracies of direct genomic breeding values (DGV) for carcass traits were estimated by applying fivefold cross-validation to a dataset including 1183 animals and approximately 34,000 single nucleotide polymorphisms (SNPs). Accuracies of BayesC, Bayesian LASSO (BayesL) and genomic best linear unbiased prediction (GBLUP) methods were similar for BT, EMA and MS. However, for CW, DGV accuracy was 7% higher with BayesC than with BayesL and GBLUP. The increased accuracy of BayesC, compared to GBLUP and BayesL, was maintained for CW, regardless of the training sample size, but not for BT, EMA, and MS. Genome-wide association studies detected consistent large effects for SNPs on chromosomes 6 and 14 for CW. The predictive performance of the models depended on the trait analyzed. For CW, the results showed a clear superiority of BayesC compared to GBLUP and BayesL. These findings indicate the importance of using a proper variable selection method for genomic selection of traits and also suggest that the genetic architecture that underlies CW differs from that of the other carcass traits analyzed. Thus, our study provides significant new insights into the carcass traits of Hanwoo cattle.

Infrared metamaterial by RF magnetron sputtered ZnO/Al:ZnO multilayers

NASA Astrophysics Data System (ADS)

Santiago, Kevin C.; Mundle, Rajeh; White, Curtis; Bahoura, Messaoud; Pradhan, Aswini K.

2018-03-01

Hyperbolic metamaterials create artificial anisotropy using metallic wires suspended in dielectric media or alternating layers of a metal and dielectric (Type I or Type II). In this study we fabricated ZnO/Al:ZnO (AZO) multilayers by the RF magnetron sputtering deposition technique. Our fabricated multilayers satisfy the requirements for a type II hyperbolic metamaterial. The optical response of individual AZO and ZnO films, as well as the multilayered film were investigated via UV-vis-IR transmittance and spectroscopic ellipsometry. The optical response of the multilayered system is calculated using the nonlocal-corrected Effective Medium Approximation (EMA). The spectroscopic ellipsometry data of the multilayered system was modeled using a uniaxial material model and EMA model. Both theoretical and experimental studies validate the fabricated multilayers undergo a hyperbolic transition at a wavelength of 2.2 μm. To our knowledge this is the first AZO/ZnO type II hyperbolic metamaterial system fabricated by magnetron sputtering deposition method.

[GENERIC DRUGS: IS BIOEQUIVALENCE SUFFICIENT TO ENSURE QUALITY, EFFICACY AND SAFETY?].

PubMed

Carrillo Norte, Juan Antonio; Postigo Mota, Salvador

2015-05-01

This article is focusing on the current debate that prescription of generic drugs is producing among patients and healthcare professionals. Following European Medicine Agency (EMA) recommendations, a number of generic medicines have recently been withdrawn from the market in Spain. The authorization for these generic drugs was primarily based on clinical studies conducted at GVK Biosciences in Hyderabad, India. The EMA inspection of GVK revealed data manipulation of electrocardiograms during the development of some studies of generic medicines. These manipulations had taken place over a period of at least five years. The article is also dealing with the consideration that bioavailability and bioequivalence studies receive as a cornerstone to approve generic drugs, and the discrepancies between the national regulatory agencies of medicines to implement guidelines of approval. Likewise, in the last few years, the rapid expansion of clinical trial activity regarding generic medicines and other drugs in emerging markets, is often leading to doubt on the integrity of the way trials were performed and on the reliability of data obtained from these studies.

An EMA/EPG Study of Vowel-to-Vowel Articulation across Velars in Southern British English

ERIC Educational Resources Information Center

Fletcher, Janet

2004-01-01

Recent studies have attested that the extent of transconsonantal vowel-to-vowel coarticulation is at least partly dependent on degree of prosodic accentuation, in languages like English. A further important factor is the mutual compatibility of consonant and vowel gestures associated with the segments in question. In this study two speakers of…

Anticancer drug discovery from the marine environment.

PubMed

Nastrucci, Candida; Cesario, Alfredo; Russo, Patrizia

2012-05-01

Discovery, isolation, biochemical/pharmacological characterization, pre-clinical and clinical trials of drugs derived from the marine environment are continuously developing and increasing. One of the most promising area is cancer therapy. Currently, there are two drugs approved by the Food and Drug Administration (FDA) and European Agency for the Evaluation of Medicinal Products (EMA) in cancer treatment, namely Cytarabine (Cytosar-U1®) and Eribulin (E7389 or Halaven®). Trabectedin (ET-743 or Yondelis1®), approved by EMA, is completing key Phase III studies in the U.S. for final approval. It was estimated that 118 marine natural products (MNPs) are currently in preclinical trials, 22 MNPs in clinical trials and 3 MNPs on the market. The characteristics and selectivity profiles of new drugs for cancer therapy, as well as drugs disclosed in related patent applications, will be the focus of this review, providing a brief and ready to use reference.

Social Anxiety and Cannabis Use: An Analysis from Ecological Momentary Assessment

PubMed Central

Buckner, Julia D.; Crosby, Ross D.; Wonderlich, Stephen A.; Schmidt, Norman B.

2011-01-01

Individuals with elevated social anxiety appear especially vulnerable to cannabis-related problems, yet little is known about the antecedents of cannabis-related behaviors among this high-risk population. The present study used ecological momentary assessment (EMA) to examine the relations among social anxiety, cannabis craving, state anxiety, situational variables, and cannabis use in the natural environment during ad-lib cannabis use episodes. Participants were 49 current cannabis users. During the two-week EMA period, social anxiety significantly interacted with cannabis craving to predict cannabis use both cross-sectionally and prospectively. Specifically, individuals with higher social anxiety and craving were most likely to use cannabis. There was a significant social anxiety X state anxiety X others’ use interaction such that when others were using cannabis, those with elevations in both trait social anxiety and state anxiety were the most likely to use cannabis. PMID:22246109

Comparative genomic analysis and phylogenetic position of Theileria equi

PubMed Central

2012-01-01

Background Transmission of arthropod-borne apicomplexan parasites that cause disease and result in death or persistent infection represents a major challenge to global human and animal health. First described in 1901 as Piroplasma equi, this re-emergent apicomplexan parasite was renamed Babesia equi and subsequently Theileria equi, reflecting an uncertain taxonomy. Understanding mechanisms by which apicomplexan parasites evade immune or chemotherapeutic elimination is required for development of effective vaccines or chemotherapeutics. The continued risk of transmission of T. equi from clinically silent, persistently infected equids impedes the goal of returning the U. S. to non-endemic status. Therefore comparative genomic analysis of T. equi was undertaken to: 1) identify genes contributing to immune evasion and persistence in equid hosts, 2) identify genes involved in PBMC infection biology and 3) define the phylogenetic position of T. equi relative to sequenced apicomplexan parasites. Results The known immunodominant proteins, EMA1, 2 and 3 were discovered to belong to a ten member gene family with a mean amino acid identity, in pairwise comparisons, of 39%. Importantly, the amino acid diversity of EMAs is distributed throughout the length of the proteins. Eight of the EMA genes were simultaneously transcribed. As the agents that cause bovine theileriosis infect and transform host cell PBMCs, we confirmed that T. equi infects equine PBMCs, however, there is no evidence of host cell transformation. Indeed, a number of genes identified as potential manipulators of the host cell phenotype are absent from the T. equi genome. Comparative genomic analysis of T. equi revealed the phylogenetic positioning relative to seven apicomplexan parasites using deduced amino acid sequences from 150 genes placed it as a sister taxon to Theileria spp. Conclusions The EMA family does not fit the paradigm for classical antigenic variation, and we propose a novel model describing the role of the EMA family in persistence. T. equi has lost the putative genes for host cell transformation, or the genes were acquired by T. parva and T. annulata after divergence from T. equi. Our analysis identified 50 genes that will be useful for definitive phylogenetic classification of T. equi and closely related organisms. PMID:23137308

Development of certified environmental management in hospital and outpatient haemodialysis units.

PubMed

García Vicente, Sergio; Morales Suárez-Varela, María; Martí Monrós, Anna; Llopis González, Agustín

2015-01-01

The environmental impact of haemodialysis is very high. Institutional activity in this sense is important, even in the production of references. Voluntary environmental management systems (EMS), environmental management and auditing systems (EMAS) and the International Organization for Standardization standards (ISO 14001) are important tools for environmental protection, together with legislation, taxation and tax benefits. To determine the degree of implementation of EMS in hospital units and outpatient haemodialysis in the Spanish National Health System to provide a group of reference centres in environmental management in this healthcare activity. Development of a list by autonomous communities showing hospital and outpatient dialysis units using an EMAS and/or ISO 14001 in 2012-2013. The sources of information were the Spanish National Catalogue of Hospitals, Spanish Registry of Healthcare Certification and Accreditation, European and regional EMAS records, world ISO registrations, dialysis centre lists from scientific societies and patients, responses from accredited entities in Spain for environmental certification and the institutional website of each haemodialysis centre identified. Of the 210 hospitals with a dialysis unit, 53 (25%) have the ISO 14001 and 15 of these also have an EMAS). This constitutes 30% of all hospital dialysis chairs in Spain: 1,291 (of 4,298). Only 11 outpatient clinics are recorded, all with the ISO 14001. There is no official documentation of the implementation of EMS in dialysis units. Making this list provides an approach to the situation, with special reference to haemodialysis because of its significant environmental impact. Copyright © 2015 Sociedad Española de Nefrología. Published by Elsevier España, S.L.U. All rights reserved.

A Road Map to Canadian Chemical Recovery Handbook for Inhabited Areas: Scoping Study

DTIC Science & Technology

2014-05-01

A Road Map to Canadian Chemical Recovery Handbook for I © Her Majesty the Queen in Right of Canada, as represented by the Minister of National...Australia (EMA) Office of Attorney General, Canberra. b) Australian Emergency Management Institute Mount Macedon, Victoria

Pharmacokinetics of Selected Anticancer Drugs in Elderly Cancer Patients: Focus on Breast Cancer

PubMed Central

Crombag, Marie-Rose B.S.; Joerger, Markus; Thürlimann, Beat; Schellens, Jan H.M.; Beijnen, Jos H.; Huitema, Alwin D.R.

2016-01-01

Background: Elderly patients receiving anticancer drugs may have an increased risk to develop treatment-related toxicities compared to their younger peers. However, a potential pharmacokinetic (PK) basis for this increased risk has not consistently been established yet. Therefore, the objective of this study was to systematically review the influence of age on the PK of anticancer agents frequently administered to elderly breast cancer patients. Methods: A literature search was performed using the PubMed electronic database, Summary of Product Characteristics (SmPC) and available drug approval reviews, as published by EMA and FDA. Publications that describe age-related PK profiles of selected anticancer drugs against breast cancer, excluding endocrine compounds, were selected and included. Results: This review presents an overview of the available data that describe the influence of increasing age on the PK of selected anticancer drugs used for the treatment of breast cancer. Conclusions: Selected published data revealed differences in the effect and magnitude of increasing age on the PK of several anticancer drugs. There may be clinically-relevant, age-related PK differences for anthracyclines and platina agents. In the majority of cases, age is not a good surrogate marker for anticancer drug PK, and the physiological state of the individual patient may better be approached by looking at organ function, Charlson Comorbidity Score or geriatric functional assessment. PMID:26729170

Efficient finite element modelling for the investigation of the dynamic behaviour of a structure with bolted joints

NASA Astrophysics Data System (ADS)

Omar, R.; Rani, M. N. Abdul; Yunus, M. A.; Mirza, W. I. I. Wan Iskandar; Zin, M. S. Mohd

2018-04-01

A simple structure with bolted joints consists of the structural components, bolts and nuts. There are several methods to model the structures with bolted joints, however there is no reliable, efficient and economic modelling methods that can accurately predict its dynamics behaviour. Explained in this paper is an investigation that was conducted to obtain an appropriate modelling method for bolted joints. This was carried out by evaluating four different finite element (FE) models of the assembled plates and bolts namely the solid plates-bolts model, plates without bolt model, hybrid plates-bolts model and simplified plates-bolts model. FE modal analysis was conducted for all four initial FE models of the bolted joints. Results of the FE modal analysis were compared with the experimental modal analysis (EMA) results. EMA was performed to extract the natural frequencies and mode shapes of the test physical structure with bolted joints. Evaluation was made by comparing the number of nodes, number of elements, elapsed computer processing unit (CPU) time, and the total percentage of errors of each initial FE model when compared with EMA result. The evaluation showed that the simplified plates-bolts model could most accurately predict the dynamic behaviour of the structure with bolted joints. This study proved that the reliable, efficient and economic modelling of bolted joints, mainly the representation of the bolting, has played a crucial element in ensuring the accuracy of the dynamic behaviour prediction.

Does substance use moderate the association of neighborhood disadvantage with perceived stress and safety in the activity spaces of urban youth?

PubMed

Mennis, Jeremy; Mason, Michael; Light, John; Rusby, Julie; Westling, Erika; Way, Thomas; Zahakaris, Nikola; Flay, Brian

2016-08-01

This study investigates the association of activity space-based exposure to neighborhood disadvantage with momentary perceived stress and safety, and the moderation of substance use on those associations, among a sample of 139 urban, primarily African American, adolescents. Geospatial technologies are integrated with Ecological Momentary Assessment (EMA) to capture exposure to neighborhood disadvantage and perceived stress and safety in the activity space. A relative neighborhood disadvantage measure for each subject is calculated by conditioning the neighborhood disadvantage observed at the EMA location on that of the home neighborhood. Generalized estimating equations (GEE) are used to model the effect of relative neighborhood disadvantage on momentary perceived stress and safety, and the extent to which substance use moderates those associations. Relative neighborhood disadvantage is significantly associated with higher perceived stress, lower perceived safety, and greater substance use involvement. The association of relative neighborhood disadvantage with stress is significantly stronger among those with greater substance use involvement. This research highlights the value of integrating geospatial technologies with EMA and developing personalized measures of environmental exposure for investigating neighborhood effects on substance use, and suggests substance use intervention strategies aimed at neighborhood conditions. Future research should seek to disentangle the causal pathways of influence and selection that relate neighborhood environment, stress, and substance use, while also accounting for the role of gender and family and peer social contexts. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Commentary on the MID3 Good Practices Paper.

PubMed

Manolis, Efthymios; Brogren, Jacob; Cole, Susan; Hay, Justin L; Nordmark, Anna; Karlsson, Kristin E; Lentz, Frederike; Benda, Norbert; Wangorsch, Gaby; Pons, Gerard; Zhao, Wei; Gigante, Valeria; Serone, Francesca; Standing, Joseph F; Dokoumetzidis, Aris; Vakkilainen, Juha; van den Heuvel, Michiel; Mangas Sanjuan, Victor; Taminiau, Johannes; Kerwash, Essam; Khan, David; Musuamba, Flora Tshinanu; Skottheim Rusten, Ine

2017-07-01

During the last 10 years the European Medicines Agency (EMA) organized a number of workshops on modeling and simulation, working towards greater integration of modeling and simulation (M&S) in the development and regulatory assessment of medicines. In the 2011 EMA - European Federation of Pharmaceutical Industries and Associations (EFPIA) Workshop on Modelling and Simulation, European regulators agreed to the necessity to build expertise to be able to review M&S data provided by companies in their dossier. This led to the establishment of the EMA Modelling and Simulation Working Group (MSWG). Also, there was agreement reached on the need for harmonization on good M&S practices and for continuing dialog across all parties. The MSWG acknowledges the initiative of the EFPIA Model-Informed Drug Discovery and Development (MID3) group in promoting greater consistency in practice, application, and documentation of M&S and considers the paper is an important contribution towards achieving this objective. © 2017 The Authors CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.

A Diagnostic Approach for Electro-Mechanical Actuators in Aerospace Systems

NASA Technical Reports Server (NTRS)

Balaban, Edward; Saxena, Abhinav; Bansal, Prasun; Goebel, Kai Frank; Stoelting, Paul; Curran, Simon

2009-01-01

Electro-mechanical actuators (EMA) are finding increasing use in aerospace applications, especially with the trend towards all all-electric aircraft and spacecraft designs. However, electro-mechanical actuators still lack the knowledge base accumulated for other fielded actuator types, particularly with regard to fault detection and characterization. This paper presents a thorough analysis of some of the critical failure modes documented for EMAs and describes experiments conducted on detecting and isolating a subset of them. The list of failures has been prepared through an extensive Failure Modes and Criticality Analysis (FMECA) reference, literature review, and accessible industry experience. Methods for data acquisition and validation of algorithms on EMA test stands are described. A variety of condition indicators were developed that enabled detection, identification, and isolation among the various fault modes. A diagnostic algorithm based on an artificial neural network is shown to operate successfully using these condition indicators and furthermore, robustness of these diagnostic routines to sensor faults is demonstrated by showing their ability to distinguish between them and component failures. The paper concludes with a roadmap leading from this effort towards developing successful prognostic algorithms for electromechanical actuators.

Energy materials coordinating committee (EMACC) Fiscal Year 1982. Annual technical report

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

None, None

1983-03-01

The DOE Energy Materials Coordinating Committee (EMaCC) serves primarily to enhance coordination among the Department's materials programs and to further the effective use of materials expertise within the Department. These functions are accomplished through the exchange of budgetary and planning information among program managers and through technical meetings/ workshops on selected topics involving both DOE and major contractors. In addition, the EMaCC aids in obtaining materials - related inputs for both intra- and interagency compilations. Membership in the EMaCC is open to any Department organizational unit; participants are appointed by Division or Office Directors. The current membership is listed inmore » Table 1. The EMACC reports to the Director of the Office of Energy Research in his capacity as overseer of the technical programs of the Department. This annual technical report is mandated by the EMACC terms of reference. In this report are described 1) EMACC activities for FY 1982; 2) a summary of materials funding in the Department from FY 1978 to the present; and 3) on-going materials programs in the Department.« less

The adverse drug reaction reporting assignment for specialist oncology nurses: a preliminary evaluation of quality, relevance and educational value in a prospective cohort study.

PubMed

Schutte, Tim; van Eekeren, Rike; Richir, Milan; van Staveren, Jojanneke; van Puijenbroek, Eugène; Tichelaar, Jelle; van Agtmael, Michiel

2018-01-01

In a new prescribing qualification course for specialist oncology nurses, we thought that it is important to emphasize pharmacovigilance and adverse drug reaction (ADR) reporting. We aimed to develop and evaluate an ADR reporting assignment for specialist oncology nurses. The quality of report documentation was assessed with the "Clinical Documentation tool to assess Individual Case Safety Reports" (ClinDoc). The relevance of the reports was evaluated in terms of ADR seriousness, the listing for additional monitoring of the drug by European Medicines Agency (EMA), and lack of labelling information about the ADR. Nurses' opinions of the assignment were evaluated using an E-survey. Thirty-three ADRs were reported, 32 (97%) of which were well documented according to ClinDoc. Thirteen ADRs (39%) were "serious" according to CIOMS criteria. In five cases (15%), the suspect drugs were listed for additional monitoring by EMA and in seven cases (21%), the ADR was not mentioned in the Summary of Product Characteristics. Twenty-five (78.1%) of the 32 enrolled nurses completed the E-survey. Most were > 45 years of age (68%), female (92%) and had extensive clinical experience (6-33 years). All agreed or completely agreed that the reporting assignment was useful, that it fitted in daily practice and that it increased their attention for medication/patient safety. A large majority (84.0%) agreed the assignment changed how they dealt with ADRs. Specialist oncology nurses are capable of reporting ADRs, and they considered the assignment useful. The assignment yielded valuable, relevant, and well-documented ADR reports for pharmacovigilance practice.

Scientific Research Program for Power, Energy, and Thermal Technologies. Task Order 0002: Power, Thermal and Control Technologies and Processes Experimental Research. Subtask: Laboratory Test Set-up to Evaluate Electromechanical Actuation Systems for Aircraft Flight Control

DTIC Science & Technology

2015-08-01

faults are incorporated into the system in order to better understand the EMA reliability, and to aid in designing fault detection software for real...to a fixed angle repeatedly and accurately [16]. The motor in the EHA is used to drive a reversible pump tied to a hydraulic cylinder which moves...24] [25] [26]. These test stands are used for the prognostic testing of EMAS that have had mechanical or electrical faults injected into them. The

Evaluating Zeolite-Modified Sensors: towards a faster set of chemical sensors

NASA Astrophysics Data System (ADS)

Berna, A. Z.; Vergara, A.; Trincavelli, M.; Huerta, R.; Afonja, A.; Parkin, I. P.; Binions, R.; Trowell, S.

2011-09-01

The responses of zeolite-modified sensors, prepared by screen printing layers of chromium titanium oxide (CTO), were compared to unmodified tin oxide sensors using amplitude and transient responses. For transient responses we used a family of features, derived from the exponential moving average (EMA), to characterize chemo-resistive responses. All sensors were tested simultaneously against 20 individual volatile compounds from four chemical groups. The responses of the two types of sensors showed some independence. The zeolite-modified CTO sensors discriminated compounds better using either amplitude response or EMA features and CTO-modified sensors also responded three times faster.

Disparity in the "time to patient access" to new anti-cancer drugs in Italian regions. Results of a survey conducted by the Italian Society of Medical Oncology (AIOM).

PubMed

Gori, Stefania; Di Maio, Massimo; Pinto, Carmine; Alabiso, Oscar; Baldini, Editta; Barbato, Enrico; Beretta, Giordano Domenico; Bravi, Stefano; Caffo, Orazio; Canobbio, Luciano; Carrozza, Francesco; Cinieri, Saverio; Cruciani, Giorgio; Dinota, Angelo; Gebbia, Vittorio; Giustini, Lucio; Graiff, Claudio; Molino, Annamaria; Muggiano, Antonio; Pandoli, Giuliano; Puglisi, Fabio; Tagliaferri, Pierosandro; Tomao, Silverio; Venturini, Marco

2011-01-01

In 2009, the Italian Society of Medical Oncology (AIOM) conducted a survey to describe the impact of regional pharmaceutical formularies on the disparity of access to eight new drugs among cancer patients treated in Italian regions. The survey documented some regional restrictions for some anti-cancer drugs. In the study, we analyzed the "time to patient access" to new anti-cancer drugs in Italian regions. In March 2010, we analyzed the availability of 17 new anti-cancer drugs at a regional level, specifically the coherence of regional authorizations compared with national authorizations approved by the Italian Medicines Agency (AIFA). In the regions with pharmaceutical formularies, we analyzed the characteristics of technical-scientific committees for the evaluation of inclusion of hospital drugs in these formularies. We also analyzed the time from EMA (CMPH) authorization to AIFA marketing authorization, the time from AIFA marketing authorization to patient availability, and the total time from EMA (CMPH) authorization to patient availability of the drugs in all Italian regions, for 11 of these drugs. Some drugs were included in all the regional pharmaceutical formularies, without restrictions, whereas other drugs were not included in one and others were not included in more than one formulary. Median time from EMA to AIFA was 11.2 months (range, 2.9-17.1). Median time from AIFA to patient availability was 1.4 months (range, 0.0-50.5) in regions with drug formularies versus 0.0 months in regions without drugs formularies. Median total time from EMA to patient availability was longer in regions with formularies (13.3 months; range, 2.9-65.3) than in regions without formularies (11.2 months; range, 2.9-24.0), where drugs are immediately available after AIFA marketing authorization. Moreover, the interval was very long (range, 2.9-65.3) for some drugs in regions with formularies. The analysis confirmed that the presence of multiple hierarchical levels of drug evaluation can create disparity in drug availability for Italian citizens.

Superconducting ECR ion source: From 24-28 GHz SECRAL to 45 GHz fourth generation ECR

NASA Astrophysics Data System (ADS)

Zhao, H. W.; Sun, L. T.; Guo, J. W.; Zhang, W. H.; Lu, W.; Wu, W.; Wu, B. M.; Sabbi, G.; Juchno, M.; Hafalia, A.; Ravaioli, E.; Xie, D. Z.

2018-05-01

The development of superconducting ECR source with higher magnetic fields and higher microwave frequency is the most straight forward path to achieve higher beam intensity and higher charge state performance. SECRAL, a superconducting third generation ECR ion source, is designed for 24-28 GHz microwave frequency operation with an innovative magnet configuration of sextupole coils located outside the three solenoids. SECRAL at 24 GHz has already produced a number of record beam intensities, such as 40Ar12+ 1.4 emA, 129Xe26+ 1.1 emA, 129Xe30+ 0.36 emA, and 209Bi31+ 0.68 emA. SECRAL-II, an upgraded version of SECRAL, was built successfully in less than 3 years and has recently been commissioned at full power of a 28 GHz gyrotron and three-frequency heating (28 + 45 + 18 GHz). New record beam intensities for highly charged ion production have been achieved, such as 620 eμA 40Ar16+, 15 eμA 40Ar18+, 146 eμA 86Kr28+, 0.5 eμA 86Kr33+, 53 eμA 129Xe38+, and 17 eμA 129Xe42+. Recent beam test results at SECRAL and SECRAL II have demonstrated that the production of more intense highly charged heavy ion beams needs higher microwave power and higher frequency, as the scaling law predicted. A 45 GHz superconducting ECR ion source FECR (a first fourth generation ECR ion source) is being built at IMP. FECR will be the world's first Nb3Sn superconducting-magnet-based ECR ion source with 6.5 T axial mirror field, 3.5 T sextupole field on the plasma chamber inner wall, and 20 kW at a 45 GHz microwave coupling system. This paper will focus on SECRAL performance studies at 24-28 GHz and technical design of 45 GHz FECR, which demonstrates a technical path for highly charged ion beam production from 24 to 28 GHz SECRAL to 45 GHz FECR.

Revisiting the Affect Regulation Model of Binge Eating: A Meta-Analysis of Studies Using Ecological Momentary Assessment

ERIC Educational Resources Information Center

Haedt-Matt, Alissa A.; Keel, Pamela K.

2011-01-01

The affect regulation model of binge eating, which posits that patients binge eat to reduce negative affect (NA), has received support from cross-sectional and laboratory-based studies. Ecological momentary assessment (EMA) involves momentary ratings and repeated assessments over time and is ideally suited to identify temporal antecedents and…

A Cross-Species Mode of Action (Moa) Information Assessment: A Case Study of Bisphenol a (BPA)

EPA Science Inventory

EPA has released a report entitled, A Cross-Species Mode of Action Information Assessment: A Case Study of Bisphenol A [EPA/600/R-50/044F] . This report describes an approach to predict chemical effects and mode of action (MOA) for animal species without data from MOA i...

Development of a smartphone application to measure physical activity using sensor-assisted self-report.

PubMed

Dunton, Genevieve Fridlund; Dzubur, Eldin; Kawabata, Keito; Yanez, Brenda; Bo, Bin; Intille, Stephen

2014-01-01

Despite the known advantages of objective physical activity monitors (e.g., accelerometers), these devices have high rates of non-wear, which leads to missing data. Objective activity monitors are also unable to capture valuable contextual information about behavior. Adolescents recruited into physical activity surveillance and intervention studies will increasingly have smartphones, which are miniature computers with built-in motion sensors. This paper describes the design and development of a smartphone application ("app") called Mobile Teen that combines objective and self-report assessment strategies through (1) sensor-informed context-sensitive ecological momentary assessment (CS-EMA) and (2) sensor-assisted end-of-day recall. The Mobile Teen app uses the mobile phone's built-in motion sensor to automatically detect likely bouts of phone non-wear, sedentary behavior, and physical activity. The app then uses transitions between these inferred states to trigger CS-EMA self-report surveys measuring the type, purpose, and context of activity in real-time. The end of the day recall component of the Mobile Teen app allows users to interactively review and label their own physical activity data each evening using visual cues from automatically detected major activity transitions from the phone's built-in motion sensors. Major activity transitions are identified by the app, which cues the user to label that "chunk," or period, of time using activity categories. Sensor-driven CS-EMA and end-of-day recall smartphone apps can be used to augment physical activity data collected by objective activity monitors, filling in gaps during non-wear bouts and providing additional real-time data on environmental, social, and emotional correlates of behavior. Smartphone apps such as these have potential for affordable deployment in large-scale epidemiological and intervention studies.

Celiac disease in non-clinical populations of Japan.

PubMed

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

2018-02-01

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

Development of a Smartphone Application to Measure Physical Activity Using Sensor-Assisted Self-Report

PubMed Central

Dunton, Genevieve Fridlund; Dzubur, Eldin; Kawabata, Keito; Yanez, Brenda; Bo, Bin; Intille, Stephen

2013-01-01

Introduction: Despite the known advantages of objective physical activity monitors (e.g., accelerometers), these devices have high rates of non-wear, which leads to missing data. Objective activity monitors are also unable to capture valuable contextual information about behavior. Adolescents recruited into physical activity surveillance and intervention studies will increasingly have smartphones, which are miniature computers with built-in motion sensors. Methods: This paper describes the design and development of a smartphone application (“app”) called Mobile Teen that combines objective and self-report assessment strategies through (1) sensor-informed context-sensitive ecological momentary assessment (CS-EMA) and (2) sensor-assisted end-of-day recall. Results: The Mobile Teen app uses the mobile phone’s built-in motion sensor to automatically detect likely bouts of phone non-wear, sedentary behavior, and physical activity. The app then uses transitions between these inferred states to trigger CS-EMA self-report surveys measuring the type, purpose, and context of activity in real-time. The end of the day recall component of the Mobile Teen app allows users to interactively review and label their own physical activity data each evening using visual cues from automatically detected major activity transitions from the phone’s built-in motion sensors. Major activity transitions are identified by the app, which cues the user to label that “chunk,” or period, of time using activity categories. Conclusion: Sensor-driven CS-EMA and end-of-day recall smartphone apps can be used to augment physical activity data collected by objective activity monitors, filling in gaps during non-wear bouts and providing additional real-time data on environmental, social, and emotional correlates of behavior. Smartphone apps such as these have potential for affordable deployment in large-scale epidemiological and intervention studies. PMID:24616888

Intraindividual Covariation Between E-Cigarette and Combustible Cigarette Use in Korean American Emerging Adults

PubMed Central

Huh, Jimi; Leventhal, Adam M.

2017-01-01

Critical gaps exist in understanding the patterns and correlates of dual use of electronic cigarettes (ECs) and combustible cigarettes (CCs), particularly in ethnic minority populations. In this study, we assessed CC and EC use in the naturalistic environment using ecological momentary assessment (EMA). We hypothesized that within-subject variation in EC use (yes/no each day) would be inversely associated with within-subject variation in number of CCs consumed and craving during that same day. We also examined gender and nicotine dependence as moderators of the EC-CC and EC-craving covariations. Korean American emerging adult (KAEA; 18–25 years old) smokers (N = 78) completed 7 days of EMA. Participants completed EMA surveys throughout the day, which assessed CC craving, and end-of-day surveys, which assessed EC use and the number of CCs smoked that day. Generalized linear mixed models were used to predict day-level EC use, with number of CCs smoked and craving during that same day, gender, and nicotine dependence as predictors (n = 501). We found that within-subject variation in CC use was not associated with same-day EC use; neither was within-subject variation in craving (ps > .27). Gender moderated the relationship between craving and EC use on a given day (p = .03); only for females, on the days with higher craving, the likelihood of their EC use that day was significantly heightened. This study does not suggest that EC use is linked with lower CC smoking quantity, at least at the day level and among KAEA smokers. CC craving may play a role in dual EC-CC use for KAEA female smokers. PMID:26618795

Intraindividual covariation between e-cigarette and combustible cigarette use in Korean American emerging adults.

PubMed

Huh, Jimi; Leventhal, Adam M

2016-03-01

Critical gaps exist in understanding the patterns and correlates of dual use of electronic cigarettes (ECs) and combustible cigarettes (CCs), particularly in ethnic minority populations. In this study, we assessed CC and EC use in the naturalistic environment using ecological momentary assessment (EMA). We hypothesized that within-subject variation in EC use (yes/no each day) would be inversely associated with within-subject variation in number of CCs consumed and craving during that same day. We also examined gender and nicotine dependence as moderators of the EC-CC and EC-craving covariations. Korean American emerging adult (KAEA; 18-25 years old) smokers (N = 78) completed 7 days of EMA. Participants completed EMA surveys throughout the day, which assessed CC craving, and end-of-day surveys, which assessed EC use and the number of CCs smoked that day. Generalized linear mixed models were used to predict day-level EC use, with number of CCs smoked and craving during that same day, gender, and nicotine dependence as predictors (n = 501). We found that within-subject variation in CC use was not associated with same-day EC use; neither was within-subject variation in craving (ps > .27). Gender moderated the relationship between craving and EC use on a given day (p = .03); only for females, on the days with higher craving, the likelihood of their EC use that day was significantly heightened. This study does not suggest that EC use is linked with lower CC smoking quantity, at least at the day level and among KAEA smokers. CC craving may play a role in dual EC-CC use for KAEA female smokers. (c) 2016 APA, all rights reserved).

Coping with missing data in phase III pivotal registration trials: Tolvaptan in subjects with kidney disease, a case study.

PubMed

Ouyang, John; Carroll, Kevin J; Koch, Gary; Li, Junfang

2017-07-01

Missing data cause challenging issues, particularly in phase III registration trials, as highlighted by the European Medicines Agency (EMA) and the US National Research Council. We explore, as a case study, how the issues from missing data were tackled in a double-blind phase III trial in subjects with autosomal dominant polycystic kidney disease. A total of 1445 subjects were randomized in a 2:1 ratio to receive active treatment (tolvaptan), or placebo. The primary outcome, the rate of change in total kidney volume, favored tolvaptan (P < .0001). The key secondary efficacy endpoints of clinical progression of disease and rate of decline in kidney function also favored tolvaptan. However, as highlighted by Food and Drug Administration and EMA, the interpretation of results was hampered by a high number of unevenly distributed dropouts, particularly early dropouts. In this paper, we outline the analyses undertaken to address the issue of missing data thoroughly. "Tipping point analyses" were performed to explore how extreme and detrimental outcomes among subjects with missing data must be to overturn the positive treatment effect attained in those subjects who had complete data. Nonparametric rank-based analyses were also performed accounting for missing data. In conclusion, straightforward and transparent analyses directly taking into account missing data convincingly support the robustness of the preplanned analyses on the primary and secondary endpoints. Tolvaptan was confirmed to be effective in slowing total kidney volume growth, which is considered an efficacy endpoint by EMA, and in lessening the decline in renal function in patients with autosomal dominant polycystic kidney disease. Copyright © 2017 John Wiley & Sons, Ltd.

Emergy evaluation of contrasting dairy systems at multiple levels.

PubMed

Vigne, Mathieu; Peyraud, Jean-Louis; Lecomte, Philippe; Corson, Michael S; Wilfart, Aurélie

2013-11-15

Emergy accounting (EmA) was applied to a range of dairy systems, from low-input smallholder systems in South Mali (SM), to intermediate-input systems in two regions of France, Poitou-Charentes (PC) and Bretagne (BR), to high-input systems on Reunion Island (RI). These systems were studied at three different levels: whole-farm (dairy system and cropping system), dairy-system (dairy herd and forage land), and herd (animals only). Dairy farms in SM used the lowest total emergy at all levels and was the highest user of renewable resources. Despite the low quality of resources consumed (crop residues and natural pasture), efficiency of their use was similar to that of industrialised inputs by intensive systems in RI, PC and BR. In addition, among the systems studied, SM dairy farms lay closest to environmental sustainability, contradicting the usual image of high environmental impact of cattle production in developing countries. EmA also revealed characteristics of the three intensive systems. Systems from RI and PC had lower resource transformation efficiency and higher environmental impacts than those from BR, due mainly to feeding strategies that differed due to differing socio-climatic constraints. Application of EmA at multiple levels revealed the importance of a multi-level analysis. While the whole-farm level assesses the overall contribution of the system to its environment, the dairy-system level is suitable for comparison of multi-product systems. In contrast, the herd level focuses on herd management and bypasses debates about definition of system boundaries by excluding land management. Combining all levels highlights the contribution of livestock to the global agricultural system and identifies inefficiencies and influences of system components on the environment. Copyright © 2013 Elsevier Ltd. All rights reserved.

Antibodies against deamidated gliadin peptides identify adult coeliac disease patients negative for antibodies against endomysium and tissue transglutaminase.

PubMed

Dahle, C; Hagman, A; Ignatova, S; Ström, M

2010-07-01

This study was done to evaluate the diagnostic utility of antibodies against deamidated gliadin peptides compared to traditional markers for coeliac disease. To evaluate diagnostic utility of antibodies against deamidated gliadin peptide (DGP). Sera from 176 adults, referred for endoscopy without previous analysis of antibodies against tissue transglutaminase (tTG) or endomysium (EmA), were retrospectively analysed by ELISAs detecting IgA/IgG antibodies against DGP or a mixture of DGP and tTG, and compared with IgA-tTG and EmA. Seventy-nine individuals were diagnosed with coeliac disease. Receiver operating characteristic analyses verified the manufacturers' cut-off limits except for IgA/IgG-DGP/tTG. In sera without IgA deficiency, the sensitivity was higher for IgA/IgG-DGP (0.85-0.87) compared with IgA-tTg (0.76) and EmA (0.61). All tests showed high specificity (0.95-1.00). Eighteen coeliac disease-sera were negative regarding IgA-tTG, nine of which were positive for IgA/IgG-DGP. Sera from coeliac disease-patients >70 years were more often negative for IgA-tTG (50%) and IgA/IgG-DGP (36%) than younger patients (15% and 8% respectively) (P < 0.01). Three of the four IgA-deficient patients were positive in the IgA/IgG-DGP assay. In this study of patients unselected regarding IgA-tTg/EmA, thus unbiased in this respect, IgA/IgG-DGP identified adult coeliac disease patients negative for antibodies against endomysium and tissue transglutaminase. Serology is often negative in elderly patients with coeliac disease; a small bowel biopsy should therefore be performed generously before coeliac disease is excluded.

Some of the people, some of the time: field evidence for associations and dissociations between stress and drug use.

PubMed

Furnari, Melody; Epstein, David H; Phillips, Karran A; Jobes, Michelle L; Kowalczyk, William J; Vahabzadeh, Massoud; Lin, Jia-Ling; Preston, Kenzie L

2015-10-01

Stress's role in drug use is supported by retrospective interview and laboratory studies, but prospective data confirming the association in daily life are sparse. This study aims to assess the relationship between drug use and stress in real time with ambulatory monitoring. For up to 16 weeks, 133 outpatients on opiate agonist treatment used smartphones to report each time they used drugs or felt more stressed than usual. They rated stress-event severity on a 10-point scale and as a hassle, day spoiler, or more than a day spoiler. For analysis, stress reports made within 72 h before a reported use of cocaine or opioid were binned into 24-h periods. Of 52 participants who reported stress events in the 72-h timeframe, 41 reported stress before cocaine use and 26 before opioid use. For cocaine use, the severity of stressors, rated numerically (r effect = 0.42, CL95 0.17-0.62, p = 0.00061) and percent rated as "more than a day spoiler" (r effect = 0.34, CL95 0.07-0.56, p = 0.0292)], increased linearly across the three days preceding use. The number of stressors did not predict cocaine use, and no measure of stress predicted opioid use. In ecological momentary assessment (EMA) from the whole sample of 133, stress and drug use occurred independently and there was no overall relationship. EMA did not support the idea that stress is a necessary or sufficient trigger for cocaine or heroin use after accounting for the base rates of stress and use. But EMA did show that stressful events can increase in severity in the days preceding cocaine use.

Comparisons of Food and Drug Administration and European Medicines Agency risk management implementation for recent pharmaceutical approvals: report of the International Society for Pharmacoeconomics and outcomes research risk benefit management working group.

PubMed

Lis, Yvonne; Roberts, Melissa H; Kamble, Shital; J Guo, Jeff; Raisch, Dennis W

2012-12-01

1) To compare the Food and Drug Administration's (FDA's) Risk Evaluation and Mitigation Strategies (REMS) and European Medicines Agency's (EMA's) Risk Management Plan (RMP) guidances and 2) to compare REMS and RMPs for specific chemical entities and biological products. FDA, EMA, and pharmaceutical company Web sites were consulted for details pertaining to REMS and RMPs. REMS requirements include medication guides, communication plans, elements to ensure safe use, implementation systems, and specified assessment intervals. RMP requirements are increased pharmacovigilance and risk minimization activities. We compared these requirements for drugs requiring both REMS and RMPs. We identified 95 drugs on FDA's REMS list as of March 2010. Of these, there were 29 drugs (11 biologics and 18 new chemical entities) with EMA RMPs. REMS and RMPs are similar in objectives, with comparable toolkits. Both allow flexibility in product-specific actions, recognizing adverse effects of potential concern. Of the 29 drugs reviewed, REMS requirements not included in RMPs were patient medication guides (100% of the drugs), provider communication plans (38%), and routine monitoring of REMS (66%). RMP requirements not included in REMS were specific adverse event reporting (45% of the drugs), prospective registry studies (34%), prospective epidemiology studies (24%), additional trial data (28%), and Summary of Product Characteristics contraindications (76%). Both REMS and RMPs provide positive guidance for identification, monitoring, and minimization of risk to patient safety. Currently, neither agency provides specific guidance on how risk should be related to benefit either qualitatively or quantitatively. Copyright © 2012 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

An Ecological Momentary Intervention to Reduce Alcohol Consumption in Young Adults Delivered During Drinking Events: Protocol for a Pilot Randomized Controlled Trial.

PubMed

Wright, Cassandra Jc; Dietze, Paul M; Agius, Paul A; Kuntsche, Emmanuel; Room, Robin; Livingston, Michael; Hellard, Margaret; Lim, Megan Sc

2017-05-25

Risky drinking is a significant public health issue in young Australian adults. Brief interventions are one of few effective methods of reducing risky drinking but are time and cost intensive; innovative methods of delivery are therefore of interest. Mobile phones offer new opportunities to collect data and intervene during risky drinking events. Mobile phones have successfully been used for delivery of alcohol-related brief interventions and data collection but not in combination with or during drinking events. This pilot study will investigate the efficacy of an ecological momentary intervention (EMI), with combined ecological momentary assessment (EMA) and brief intervention delivered by mobile phones to young adults during risky drinking events. We will use a 3-armed randomized controlled trial to investigate the efficacy of the intervention for reducing peak single occasion drinking. Our sample is recruited from an observational cohort study of young, risky drinkers. Participants will be randomized into 1 of 3 intervention arms. On 6 nights across a 12-week study period, EMI and EMA groups will complete hourly EMA surveys on their mobile phone. EMI participants will receive tailored feedback short message service (SMS) texts corresponding to their EMA survey responses. The EMI participants will not receive feedback SMS. A third group will have no contact (no-contact control). All groups will then be contacted for a follow-up interview within 4 weeks of the 12-week study period ending. The primary outcome is mean reduction in standard drinks consumed during their most recent heavy drinking occasion as measured at follow-up. Secondary outcomes include alcohol consumption over the previous 6 months, experiences of alcohol-related harms, attitudes toward drinking and drunkenness, hazardous drinking and use of tobacco and illicit drugs. A random effects mixed modelling approach using maximum likelihood estimation will be used to provide estimates of differences in mean drinking levels between those receiving the intervention and control participants. This study is novel in that, unlike previous work, it will intervene repeatedly during single occasion drinking events. Further, it extends previous research in this area, which has applied limited tailoring of message content for SMS-based brief interventions. The findings of this study will contribute to the growing body of evidence to inform the use of mobile health interventions for reducing alcohol consumption and harms. Australian New Zealand Clinical Trials ACTRN12616001323415; https://www.anzctr.org.au/ Trial/Registration/TrialReview.aspx?id=369534 (Archived by WebCite at http://www.webcitation.org/ 6qDqBZV9b). ©Cassandra JC Wright, Paul M Dietze, Paul A Agius, Emmanuel Kuntsche, Robin Room, Michael Livingston, Margaret Hellard, Megan SC Lim. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 25.05.2017.

An Ecological Momentary Intervention to Reduce Alcohol Consumption in Young Adults Delivered During Drinking Events: Protocol for a Pilot Randomized Controlled Trial

PubMed Central

Dietze, Paul M; Agius, Paul A; Kuntsche, Emmanuel; Room, Robin; Livingston, Michael; Hellard, Margaret; Lim, Megan SC

2017-01-01

Background Risky drinking is a significant public health issue in young Australian adults. Brief interventions are one of few effective methods of reducing risky drinking but are time and cost intensive; innovative methods of delivery are therefore of interest. Mobile phones offer new opportunities to collect data and intervene during risky drinking events. Mobile phones have successfully been used for delivery of alcohol-related brief interventions and data collection but not in combination with or during drinking events. Objective This pilot study will investigate the efficacy of an ecological momentary intervention (EMI), with combined ecological momentary assessment (EMA) and brief intervention delivered by mobile phones to young adults during risky drinking events. Methods We will use a 3-armed randomized controlled trial to investigate the efficacy of the intervention for reducing peak single occasion drinking. Our sample is recruited from an observational cohort study of young, risky drinkers. Participants will be randomized into 1 of 3 intervention arms. On 6 nights across a 12-week study period, EMI and EMA groups will complete hourly EMA surveys on their mobile phone. EMI participants will receive tailored feedback short message service (SMS) texts corresponding to their EMA survey responses. The EMI participants will not receive feedback SMS. A third group will have no contact (no-contact control). All groups will then be contacted for a follow-up interview within 4 weeks of the 12-week study period ending. Results The primary outcome is mean reduction in standard drinks consumed during their most recent heavy drinking occasion as measured at follow-up. Secondary outcomes include alcohol consumption over the previous 6 months, experiences of alcohol-related harms, attitudes toward drinking and drunkenness, hazardous drinking and use of tobacco and illicit drugs. A random effects mixed modelling approach using maximum likelihood estimation will be used to provide estimates of differences in mean drinking levels between those receiving the intervention and control participants. Conclusions This study is novel in that, unlike previous work, it will intervene repeatedly during single occasion drinking events. Further, it extends previous research in this area, which has applied limited tailoring of message content for SMS-based brief interventions. The findings of this study will contribute to the growing body of evidence to inform the use of mobile health interventions for reducing alcohol consumption and harms. Trial Registration Australian New Zealand Clinical Trials ACTRN12616001323415; https://www.anzctr.org.au/ Trial/Registration/TrialReview.aspx?id=369534 (Archived by WebCite at http://www.webcitation.org/ 6qDqBZV9b) PMID:28546136

T245. THE ROLE OF PROTECTIVE FACTORS IN THE FIRST-EPISODE PSYCHOSIS: PRELIMINARY RESULTS

PubMed Central

Vila-Badia, Regina; Butjosa, Anna; Del Cacho, Núria; de Aguileta, Itziar Riera-López; Alvárez, Mar; Pardo, Marta; Coromina, Marta; Grases, Núria; Ochoa, Susana; Usall, Judith

2018-01-01

Abstract Background Currently, there is a great interest in stress since many diseases can be affected by stress, including psychotic disorders. Interpretation and capacity of the person to tackle situations of psychosocial stress and their recovery capacities are relevant factors in the prevention of psychotic disorders (López-Soler, 2008; N Pereda, 2009, 2010; Noemí Pereda, Guilera, Forns, & Gómez-Benito, 2009). Some of protector factors that have been studied are the following: Resilience (R), Coping Strategies (CS) and Social Support (SS). Furthermore, few studies have been performed with FEP population. Methods This research was part of a longitudinal observational study called ‘PROFEP Group’ in Catalonia. The patients belong to Mental Health Parc Sanitari Sant Joan de Déu (for adults) and Hospital Sant Joan de Déu (for children and adolescents) health care sector. Participants were FEP patients (N=15); males= 9, females= 6) and HC (N=19; males=6, females=13) between 14 and 42 years. We used the PANSS scale (positive, negative and general) to evaluate psychotic symptoms and DUKE (social support), EMA (coping strategies) and CD-RISC-17 (resilience) scales to evaluate protective factors. Results FEP patients showed worse resilience (p<0.05), less social support (p<0.05) and more avoidance coping strategies (p<0.05) than HC. On the other hand, in FEP patients, some protective factors correlate with the symptomatology. The DUKE scale and the EMA cautious action subscale correlate with the total PANSS, while the EMA social joining subscale correlates with the positive symptoms (p<0.05). Discussion Resilience, Coping Strategies and Social Support seem to have an important role in the appearance and severity of an FEP. It is necessary to carry out more studies with more sample, even so, the results indicate that these factors may be important for the prevention of an FEP and could be worked on in future interventions in FEP patients as well as in HC.

A New Cell Block Method for Multiple Immunohistochemical Analysis of Circulating Tumor Cells in Patients with Liver Cancer.

PubMed

Nam, Soo Jeong; Yeo, Hyun Yang; Chang, Hee Jin; Kim, Bo Hyun; Hong, Eun Kyung; Park, Joong-Won

2016-10-01

We developed a new method of detecting circulating tumor cells (CTCs) in liver cancer patients by constructing cell blocks from peripheral blood cells, including CTCs, followed by multiple immunohistochemical analysis. Cell blockswere constructed from the nucleated cell pellets of peripheral blood afterremoval of red blood cells. The blood cell blocks were obtained from 29 patients with liver cancer, and from healthy donor blood spikedwith seven cell lines. The cell blocks and corresponding tumor tissues were immunostained with antibodies to seven markers: cytokeratin (CK), epithelial cell adhesion molecule (EpCAM), epithelial membrane antigen (EMA), CK18, α-fetoprotein (AFP), Glypican 3, and HepPar1. The average recovery rate of spiked SW620 cells from blood cell blocks was 91%. CTCs were detected in 14 out of 29 patients (48.3%); 11/23 hepatocellular carcinomas (HCC), 1/2 cholangiocarcinomas (CC), 1/1 combined HCC-CC, and 1/3 metastatic cancers. CTCs from 14 patients were positive for EpCAM (57.1%), EMA (42.9%), AFP (21.4%), CK18 (14.3%), Gypican3 and CK (7.1%, each), and HepPar1 (0%). Patients with HCC expressed EpCAM, EMA, CK18, and AFP in tissue and/or CTCs, whereas CK, HepPar1, and Glypican3 were expressed only in tissue. Only EMA was significantly associated with the expressions in CTC and tissue. CTC detection was associated with higher T stage and portal vein invasion in HCC patients. This cell block method allows cytologic detection and multiple immunohistochemical analysis of CTCs. Our results show that tissue biomarkers of HCC may not be useful for the detection of CTC. EpCAM could be a candidate marker for CTCs in patients with HCC.

Nuclear fluorescence serum reactivity on monkey oesophagus: a new antibody for the follow-up of coeliac disease?

PubMed Central

Picarelli, A; Sabbatella, L; Di Tola, M; Silano, M; Nicolussi, A; D'Inzeo, S; Coppa, A

2010-01-01

We have identified previously a nuclear fluorescence reactivity (NFR) pattern on monkey oesophagus sections exposed to coeliac disease (CD) patients' sera positive for anti-endomysium antibodies (EMA). The aim of the present work was to characterize the NFR, study the time–course of NFR-positive results in relation to gluten withdrawal and evaluate the potential role of NFR in the follow-up of CD. Twenty untreated, 87 treated CD patients and 15 healthy controls were recruited and followed for 12 months. Their sera were incubated on monkey oesophagus sections to evaluate the presence of NFR by indirect immunofluorescence analysis. Duodenal mucosa samples from treated CD patients were challenged with gliadin peptides, and thus the occurrence of NFR in culture supernatants was assessed. The NFR immunoglobulins (Igs) reactivity with the nuclear extract of a human intestinal cell line was investigated. Serum NFR was present in all untreated CD patients, persisted up to 151 ± 37 days from gluten withdrawal and reappeared in treated CD patients under dietary transgressions. Serum NFR was also detected in two healthy controls. In culture supernatants of coeliac intestinal mucosa challenged with gliadin peptides, NFR appeared before EMA. The Igs responsible for NFR were identified as belonging to the IgA2 subclass. The NFR resulted differently from EMA and anti-nuclear antibodies, but reacted with two nuclear antigens of 65 and 49 kDa. A new autoantibody, named NFR related to CD, was described. Furthermore, NFR detection might become a valuable tool in monitoring adherence to a gluten-free diet and identifying slight dietary transgressions. PMID:20529089

Words matter: Implementing the electronically activated recorder in schizotypy.

PubMed

Minor, Kyle S; Davis, Beshaun J; Marggraf, Matthew P; Luther, Lauren; Robbins, Megan L

2018-03-01

In schizophrenia-spectrum populations, analyzing the words people use has offered promise for unlocking information about affective states and social behaviors. The electronically activated recorder (EAR) is an application-based program that is combined with widely used smartphone technology to capture a person's real-world interactions via audio recordings. It improves on the ecological validity of current methodologies by providing objective and naturalistic samples of behavior. This study is the first to implement the EAR in people endorsing elevated traits of schizophrenia-spectrum personality disorders (i.e., schizotypy), and we expected the EAR to (a) differentiate high and low schizotypy groups on affective disturbances and social engagement and (b) show that high schizotypy status moderates links between affect and social behavior using a multimethod approach. Lexical analysis of EAR recordings revealed greater negative affect and decreased social engagement in those high in schizotypy. When assessing specific traits, EAR and ecological momentary assessment (EMA) converged to show that positive schizotypy predicted negative affect. Finally, high schizotypy status moderated links between negative affect and social engagement when the EAR was combined with EMA. Adherence did not influence results, as both groups wore the EAR more than 90% of their waking hours. Findings supported using the EAR to assess real-world expressions of personality and functioning in schizotypy. Evidence also showed that the EAR can be used alongside EMA to provide a mixed-method, real-world assessment that is high in ecological validity and offers a window into the daily lives of those with elevated traits of schizophrenia-spectrum personality disorders. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

Marketing Regulatory Oversight of Advanced Therapy Medicinal Products (ATMPs) in Europe: The EMA/CAT Perspective.

PubMed

Salmikangas, Paula; Schuessler-Lenz, Martina; Ruiz, Sol; Celis, Patrick; Reischl, Ilona; Menezes-Ferreira, Margarida; Flory, Egbert; Renner, Matthias; Ferry, Nicolas

2015-01-01

With the release of Regulation 1394/2007, a new framework for gene and cell therapy medicinal products and tissue-engineered products was established in the European Union. For all three product classes, called advanced therapy medicinal products, a centralised marketing authorisation became mandatory. The European Medicines Agency (EMA) together with its Committee for Advanced Therapies, Committee for Human Medicinal Products and the network of national agencies is responsible for scientific evaluation of the marketing authorisation applications. For a new application, data and information relating to manufacturing processes and quality control of the active substance and the final product have to be submitted for evaluation together with data from non-clinical and clinical safety and efficacy studies. Technical requirements for ATMPs are defined in the legislation, and guidance for different products is available through several EMA/CAT guidelines. Due to the diversity of ATMPs, a tailored approach for regulating these products is considered necessary. Thus, a risk-based approach has been introduced for ATMPs allowing flexibility for the regulatory requirements. Since the regulatory framework for ATMPs was established, five products have been licenced in the European Union. However, the pipeline of new ATMPs is much bigger, as seen from the significant numbers of different products discussed by the CAT in scientific advice and classification procedures. In 2013, a public consultation on the ATMP Regulation was conducted by the European Commission, and the results were published in 2014. The report proposes several improvements for the current framework and established procedures for the regulation of ATMPs.

Estimation of Relative Economic Weights of Hanwoo Carcass Traits Based on Carcass Market Price

PubMed Central

Choy, Yun Ho; Park, Byoung Ho; Choi, Tae Jung; Choi, Jae Gwan; Cho, Kwang Hyun; Lee, Seung Soo; Choi, You Lim; Koh, Kyung Chul; Kim, Hyo Sun

2012-01-01

The objective of this study was to estimate economic weights of Hanwoo carcass traits that can be used to build economic selection indexes for selection of seedstocks. Data from carcass measures for determining beef yield and quality grades were collected and provided by the Korean Institute for Animal Products Quality Evaluation (KAPE). Out of 1,556,971 records, 476,430 records collected from 13 abattoirs from 2008 to 2010 after deletion of outlying observations were used to estimate relative economic weights of bid price per kg carcass weight on cold carcass weight (CW), eye muscle area (EMA), backfat thickness (BF) and marbling score (MS) and the phenotypic relationships among component traits. Price of carcass tended to increase linearly as yield grades or quality grades, in marginal or in combination, increased. Partial regression coefficients for MS, EMA, BF, and for CW in original scales were +948.5 won/score, +27.3 won/cm2, −95.2 won/mm and +7.3 won/kg when all three sex categories were taken into account. Among four grade determining traits, relative economic weight of MS was the greatest. Variations in partial regression coefficients by sex categories were great but the trends in relative weights for each carcass measures were similar. Relative economic weights of four traits in integer values when standardized measures were fit into covariance model were +4:+1:−1:+1 for MS:EMA:BF:CW. Further research is required to account for the cost of production per unit carcass weight or per unit production under different economic situations. PMID:25049531

Development of a Distance-to-Roadway Proximity Metric to Compare Near-Road Pollutant Levels to a Central Site Monitor

EPA Science Inventory

The primary objective of the Detroit Exposure and Aerosol Research Study (DEARS) was to compare air pollutant concentrations measured at various neighborhoods, or exposure monitoring areas (EMAs), throughout a major metropolitan area to levels measured at a central site or commun...

Psychosocial Correlates of Physical and Sedentary Activities of Early Adolescent Youth

ERIC Educational Resources Information Center

Rusby, Julie C.; Westling, Erika; Crowley, Ryann; Light, John M.

2014-01-01

This study examines physical and sedentary activities of early adolescent boys and girls using Ecological Momentary Assessment (EMA), a method that can link mood and behaviors in specific social situations. Twenty-seven assessments were collected across 7 days from 82 participating adolescents, three times in seventh grade and one time in eighth…

Hidradenocarcinoma: a histological and immunohistochemical study.

PubMed

Ko, Christine J; Cochran, Alistair J; Eng, William; Binder, Scott W

2006-11-01

The diagnosis of hidradenocarcinoma is difficult due to a combination of factors including inconsistent nomenclature/ classification, rarity of the neoplasm, and variable morphology of cells composing the neoplasm. Immunohistochemistry has not been previously performed on a series of hidradenocarcinomas. We evaluated six cases of hidradenocarcinoma histologically and immunohistochemically using antibodies to gross cystic disease fluid protein-15 (GCDFP-15), carcino-embryonic antigen (CEA), epithelial membrane antigen (EMA), S-100 protein, keratin AE1/3, cytokeratin 5/6, p53, bcl-1, bcl-2, and Ki67. Histology suggested concurrent eccrine and apocrine differentiation of the cases. Ki67 and p53 staining was strongly positive in five of six tumors. The neoplasms stained with antibodies to CEA, S-100 protein, GCDFP-15, EMA, bcl-1, and bcl-2 in no consistent pattern. All tumors studied stained positively for keratin AE1/3 and cytokeratin 5/6. In making the diagnosis of hidradenocarcinoma, it may be unnecessary to separate hidradenocarcinoma into eccrine and apocrine categories, and although Ki67 and p53 may be helpful, histological parameters remain paramount.

Electromechanical actuation for cryogenic valve control

NASA Technical Reports Server (NTRS)

Lister, M. J.; Reichmuth, D. M.

1993-01-01

The design and analysis of the electromechanical actuator (EMA) being developed for the NASA/Marshall Space Flight Center as part of the National Launch System (NLS) Propellant Control Effector Advanced Development Program (ADP) are addressed. The EMA design uses several proven technologies combined into a single modular package which includes single stage high ratio gear reduction, redundant electric motors mounted on a common drive shaft, redundant drive and control electronics, and digital technology for performing the closed loop position feedback, communication, and health monitoring functions. Results of tests aimed at evaluating both component characteristics and overall system performance demonstrated that the goal of low cost, reliable control in a cryogenic environment is feasible.

Developmental Testing of Electric Thrust Vector Control Systems for Manned Launch Vehicle Applications

NASA Technical Reports Server (NTRS)

Bates, Lisa B.; Young, David T.

2012-01-01

This paper describes recent developmental testing to verify the integration of a developmental electromechanical actuator (EMA) with high rate lithium ion batteries and a cross platform extensible controller. Testing was performed at the Thrust Vector Control Research, Development and Qualification Laboratory at the NASA George C. Marshall Space Flight Center. Electric Thrust Vector Control (ETVC) systems like the EMA may significantly reduce recurring launch costs and complexity compared to heritage systems. Electric actuator mechanisms and control requirements across dissimilar platforms are also discussed with a focus on the similarities leveraged and differences overcome by the cross platform extensible common controller architecture.

Rapid detection of milk adulteration using intact protein flow injection mass spectrometric fingerprints combined with chemometrics.

PubMed

Du, Lijuan; Lu, Weiying; Cai, Zhenzhen Julia; Bao, Lei; Hartmann, Christoph; Gao, Boyan; Yu, Liangli Lucy

2018-02-01

Flow injection mass spectrometry (FIMS) combined with chemometrics was evaluated for rapidly detecting economically motivated adulteration (EMA) of milk. Twenty-two pure milk and thirty-five counterparts adulterated with soybean, pea, and whey protein isolates at 0.5, 1, 3, 5, and 10% (w/w) levels were analyzed. The principal component analysis (PCA), partial least-squares-discriminant analysis (PLS-DA), and support vector machine (SVM) classification models indicated that the adulterated milks could successfully be classified from the pure milks. FIMS combined with chemometrics might be an effective method to detect possible EMA in milk. Copyright © 2017 Elsevier Ltd. All rights reserved.

Plankton And Heavy Metal Correlation From Commercial Vessels In Port Of Tanjung Emas Semarang

NASA Astrophysics Data System (ADS)

Tjahjono, Agus; Bambang, Aziz Nur; Anggoro, Sutrisno

2018-02-01

The commercial vessels activity have a big role to increase the flow of number of cargoes from a port to another port. However, the impact of these activities are the disposal of ballast water from port area to the destination port. The purpose of this research was to analyze the correlation of phytoplankton, zooplankton, and heavy metal which were contained inside the ballast water of commercial vessel towards in waters of the port of Tanjung Emas Semarang. The concentration of heavy metal either from commercial vessels or the waters in port area analyzed by Atomic Absorption Spectrophotometer (AAS). The result showed that the correlation of zooplankton and phytoplankton in the water ballast at commercial vessels have a medium correlation to zooplankton and phytoplankton in waters of Port of Tanjung Emas Semarang (PTES) were 48.9% and 58.3%. Correlation of heavy metal Cd, Zn, Cu, Zn and Pb in ballast water of commercial vessel toward each metal in waters of PTES area has a strong correlation in contribution were 76.7%, 75.6%, 71.4% and 73.8%. It showed us that the loading activity of commercial vessels in port are contributed towards the pollution in waters.

Confidence intervals for expected moments algorithm flood quantile estimates

USGS Publications Warehouse

Cohn, Timothy A.; Lane, William L.; Stedinger, Jery R.

2001-01-01

Historical and paleoflood information can substantially improve flood frequency estimates if appropriate statistical procedures are properly applied. However, the Federal guidelines for flood frequency analysis, set forth in Bulletin 17B, rely on an inefficient “weighting” procedure that fails to take advantage of historical and paleoflood information. This has led researchers to propose several more efficient alternatives including the Expected Moments Algorithm (EMA), which is attractive because it retains Bulletin 17B's statistical structure (method of moments with the Log Pearson Type 3 distribution) and thus can be easily integrated into flood analyses employing the rest of the Bulletin 17B approach. The practical utility of EMA, however, has been limited because no closed‐form method has been available for quantifying the uncertainty of EMA‐based flood quantile estimates. This paper addresses that concern by providing analytical expressions for the asymptotic variance of EMA flood‐quantile estimators and confidence intervals for flood quantile estimates. Monte Carlo simulations demonstrate the properties of such confidence intervals for sites where a 25‐ to 100‐year streamgage record is augmented by 50 to 150 years of historical information. The experiments show that the confidence intervals, though not exact, should be acceptable for most purposes.

Technology to assess and support self-management in serious mental illness

PubMed Central

Depp, Colin A.; Moore, Raeanne C.; Perivoliotis, Dimitri; Granholm, Eric

2016-01-01

The functional impairment associated with serious mental illness (SMI) places an immense burden on individuals and society, and disability often persists even after efficacious treatment of psychopathologic symptoms. Traditional methods of measuring functioning have limitations, and numerous obstacles reduce the reach and impact of evidence-based interventions developed to improve functioning in SMI. This review describes the potential of technological innovations for overcoming the challenges involved in both functional assessment and intervention in people with SMI. Ecological momentary assessment (EMA), which involves the repeated sampling of naturalistic behaviors and experiences while individuals carry out their daily lives, has provided a new window through which the determinants of day-to-day function in SMI can be observed. EMA has several advantages over traditional assessment methods and has in recent years evolved to use mobile-based platforms, such as text messaging and smartphone applications, for both assessment and promotion of self-management in people with SMI. We will review promising data regarding the acceptability, adherence, and efficacy of EMA-based mobile technologies; explore ways in which these technologies can extend the reach and impact of evidence-based psychosocial rehabilitative interventions in SMI; and outline future directions for research in this important area. PMID:27489457

Seismic images of the Brooks Range fold and thrust belt, Arctic Alaska, from an integrated seismic reflection/refraction experiment

USGS Publications Warehouse

Levander, A.; Fuis, G.S.; Wissinger, E.S.; Lutter, W.J.; Oldow, J.S.; Moore, Thomas E.

1994-01-01

We describe results of an integrated seismic reflection/refraction experiment across the Brooks Range and flanking geologic provinces in Arctic Alaska. The seismic acquisition was unusual in that reflection and refraction data were collected simultaneously with a 700 channel seismograph system deployed numerous times along a 315 km profile. Shot records show continuous Moho reflections from 0-180 km offset, as well as numerous upper- and mid-crustal wide-angle events. Single and low-fold near-vertical incidence common midpoint (CMP) reflection images show complex upper- and middle-crustal structure across the range from the unmetamorphosed Endicott Mountains allochthon (EMA) in the north, to the metamorphic belts in the south. Lower-crustal and Moho reflections are visible across the entire reflection profile. Travel-time inversion of PmP arrivals shows that the Moho, at 33 km depth beneath the North Slope foothills, deepens abruptly beneath the EMA to a maximum of 46 km, and then shallows southward to 35 km at the southern edge of the range. Two zones of upper- and middle-crustal reflections underlie the northern Brooks Range above ~ 12-15 km depth. The upper zone, interpreted as the base of the EMA, lies at a maximum depth of 6 km and extends over 50 km from the range front to the north central Brooks Range where the base of the EMA outcrops above the metasedimentary rocks exposed in the Doonerak window. We interpret the base of the lower zone, at ~ 12 km depth, to be from carbonate rocks above the master detachment upon which the Brooks Range formed. The seismic data suggest that the master detachment is connected to the faults in the EMA by several ramps. In the highly metamorphosed terranes south of the Doonerak window, the CMP section shows numerous south-dipping events which we interpret as a crustal scale duplex involving the Doonerak window rocks. The basal detachment reflections can be traced approximately 100 km, and dip southward from about 10-12 km near the range front, to 14-18 km beneath the Doonerak window, to 26-28 km beneath the metamorphic belts in the central Brooks Range. The section documents middle- and lower-crustal involvement in the formation of the Brooks Range. ?? 1994.

Patient-reported outcome labeling claims and measurement approach for metastatic castration-resistant prostate cancer treatments in the United States and European Union

PubMed Central

2014-01-01

Background Metastatic castration-resistant prostate cancer (mCRPC) and its treatment significantly affect health-related quality of life (HRQOL). Our objectives were to evaluate and compare patient-reported outcome (PRO) claims granted by the Food and Drug Administration (FDA) and European Medicines Agency (EMA) for 5 recently approved mCRPC treatments and to examine key characteristics, development, and measurement properties of the PRO measures supporting these claims against current regulatory standards. Methods Five products approved for treatment of mCRPC by the FDA and the EMA (2010–2013) were examined: enzalutamide, abiraterone, sipuleucel-T, cabazitaxel, and radium Ra 223 dichloride. United States (US) drug approval packages and European Public Assessment Reports were reviewed. PRO claims in the US labels and European Summaries of Product Characteristics and supporting measures were identified. For PRO measures supporting claims, a targeted literature review was conducted to identify information on key characteristics and measurement properties; this information was compared against FDA PRO guidance criteria. Results Nine PRO “claims” were granted across 4 of 5 products reviewed. The EMA granted more claims (7 claims—4 for pain, 3 for HRQOL) than the FDA (2 claims, both for pain). The Brief Pain Inventory–Short Form (BPI-SF) worst pain item supported most pain claims and was the only measure supporting US claims. EMA pain claims were supported by BPI-SF worst pain (n = 2) and average pain (n = 1) items and the McGill Pain Questionnaire Present Pain Intensity component (n = 1). EMA HRQOL claims were supported by the Functional Assessment of Cancer Therapy–Prostate Module (n = 2) and the EuroQol 5 Dimensions with visual analogue scale (n = 1). Pain and prostate cancer–specific HRQOL measures supporting claims met US regulatory standards for construct validity, reliability, and responsiveness; these properties were strongest for the BPI-SF worst pain item. Only the BPI-SF worst pain item has documented content validity in mCRPC. Conclusions PRO label claims were commonly granted across the mCRPC products reviewed. Among the measures reviewed, only the BPI-SF worst pain item supported US label claims. The BPI-SF worst pain item is recommended for pain assessment for the evaluation of new mCRPC treatments. PMID:24989428

Ecological Momentary Assessments and Automated Time Series Analysis to Promote Tailored Health Care: A Proof-of-Principle Study.

PubMed

van der Krieke, Lian; Emerencia, Ando C; Bos, Elisabeth H; Rosmalen, Judith Gm; Riese, Harriëtte; Aiello, Marco; Sytema, Sjoerd; de Jonge, Peter

2015-08-07

Health promotion can be tailored by combining ecological momentary assessments (EMA) with time series analysis. This combined method allows for studying the temporal order of dynamic relationships among variables, which may provide concrete indications for intervention. However, application of this method in health care practice is hampered because analyses are conducted manually and advanced statistical expertise is required. This study aims to show how this limitation can be overcome by introducing automated vector autoregressive modeling (VAR) of EMA data and to evaluate its feasibility through comparisons with results of previously published manual analyses. We developed a Web-based open source application, called AutoVAR, which automates time series analyses of EMA data and provides output that is intended to be interpretable by nonexperts. The statistical technique we used was VAR. AutoVAR tests and evaluates all possible VAR models within a given combinatorial search space and summarizes their results, thereby replacing the researcher's tasks of conducting the analysis, making an informed selection of models, and choosing the best model. We compared the output of AutoVAR to the output of a previously published manual analysis (n=4). An illustrative example consisting of 4 analyses was provided. Compared to the manual output, the AutoVAR output presents similar model characteristics and statistical results in terms of the Akaike information criterion, the Bayesian information criterion, and the test statistic of the Granger causality test. Results suggest that automated analysis and interpretation of times series is feasible. Compared to a manual procedure, the automated procedure is more robust and can save days of time. These findings may pave the way for using time series analysis for health promotion on a larger scale. AutoVAR was evaluated using the results of a previously conducted manual analysis. Analysis of additional datasets is needed in order to validate and refine the application for general use.

Ecological Momentary Assessments and Automated Time Series Analysis to Promote Tailored Health Care: A Proof-of-Principle Study

PubMed Central

Emerencia, Ando C; Bos, Elisabeth H; Rosmalen, Judith GM; Riese, Harriëtte; Aiello, Marco; Sytema, Sjoerd; de Jonge, Peter

2015-01-01

Background Health promotion can be tailored by combining ecological momentary assessments (EMA) with time series analysis. This combined method allows for studying the temporal order of dynamic relationships among variables, which may provide concrete indications for intervention. However, application of this method in health care practice is hampered because analyses are conducted manually and advanced statistical expertise is required. Objective This study aims to show how this limitation can be overcome by introducing automated vector autoregressive modeling (VAR) of EMA data and to evaluate its feasibility through comparisons with results of previously published manual analyses. Methods We developed a Web-based open source application, called AutoVAR, which automates time series analyses of EMA data and provides output that is intended to be interpretable by nonexperts. The statistical technique we used was VAR. AutoVAR tests and evaluates all possible VAR models within a given combinatorial search space and summarizes their results, thereby replacing the researcher’s tasks of conducting the analysis, making an informed selection of models, and choosing the best model. We compared the output of AutoVAR to the output of a previously published manual analysis (n=4). Results An illustrative example consisting of 4 analyses was provided. Compared to the manual output, the AutoVAR output presents similar model characteristics and statistical results in terms of the Akaike information criterion, the Bayesian information criterion, and the test statistic of the Granger causality test. Conclusions Results suggest that automated analysis and interpretation of times series is feasible. Compared to a manual procedure, the automated procedure is more robust and can save days of time. These findings may pave the way for using time series analysis for health promotion on a larger scale. AutoVAR was evaluated using the results of a previously conducted manual analysis. Analysis of additional datasets is needed in order to validate and refine the application for general use. PMID:26254160

Overview of the European Medicines Agency's Development of Product-Specific Bioequivalence Guidelines.

PubMed

Sullivan, Jane O'; Blake, Kevin; Berntgen, Michael; Salmonson, Tomas; Welink, Jan

2017-12-05

The European Medicines Agency's (EMA) product-specific bioequivalence guidelines outline harmonized regulatory requirements for studies to demonstrate bioequivalence for products that may have particular needs due to their pharmacokinetics, in addition to those outlined in general guidance. As such they are potentially very useful to the pharmaceutical industry in the development of generic medicinal products and to regulatory authorities for harmonized decision-making. Since their introduction in 2013, EMA product-specific bioequivalence guidelines continue to increase in number, and as of June 2017, encompass a number of different pharmacotherapeutic groups and pharmaceutical forms. This article further elucidates the processes involved for stakeholders and reviews the Agency's experience with the development of these guidelines, including the scientific issues witnessed with their advancement. A comparison with the United States Food and Drug Administration approach to similar guidelines is also provided. © 2017 The Authors Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.

Clinical trial transparency update: an assessment of the disclosure of results of company-sponsored trials associated with new medicines approved in Europe in 2013.

PubMed

Deane, Bryan R; Sivarajah, Jacintha

2017-03-01

The objective of this study was to assess the timely disclosure of results of company-sponsored clinical trials related to all new medicines approved by the European Medicines Agency (EMA) during 2013. This is an extension of two previously reported studies of trials related to all new medicines approved in Europe in 2009, 2010 and 2011, and in 2012. The original study found that over a three year period over three-quarters of all trials were disclosed within 12 months and almost 90% were disclosed by the end of the study. The extension study (2012 approvals) showed an improvement in results disclosure within 12 months to 90%, and an overall disclosure rate of 92% by the end of the study. The methodology used was exactly as previously reported. Various publicly available information sources were searched for both clinical trial registration and disclosure of results. All completed company-sponsored trials related to each new medicine approved for marketing by the EMA in 2013, carried out in patients and recorded on a clinical trials registry and/or included in an EMA European Public Assessment Report (EPAR), were included. Information sources were searched between 1 May and 31 July 2015. The main outcome measure was the proportion of trials for which results had been disclosed on a registry or in the scientific literature either within 12 months of the later of either first regulatory approval or trial completion, or by 31 July 2015 (end of survey). Of the completed trials associated with 34 new medicines licensed to 24 different companies in 2013, results of 90% (484/539) had been disclosed within 12 months, and results of 93% (500/539) had been disclosed by 31 July 2015. The disclosure rate within 12 months of 90% suggests that industry is continuing to achieve disclosure in a timely manner. The overall disclosure rate at study end of 93% indicates that the improvement in transparency amongst company-sponsored trials has been maintained in the trials associated with new medicines approved in 2013.

Clinical trial transparency update: an assessment of the disclosure of results of company-sponsored trials associated with new medicines approved in Europe in 2014.

PubMed

Deane, Bryan R; Porkess, Sheuli

2018-07-01

The objective of this study was to assess the timely disclosure of results of company-sponsored clinical trials related to all new medicines approved by the European Medicines Agency (EMA) during 2014. This is the final extension of three previously reported studies of trials related to all new medicines approved in Europe in 2009, 2010 and 2011, and in 2012 and 2013. The original study found that over a three-year period over three-quarters of all trials were disclosed within 12 months and almost 90% were disclosed by the end of the study (31 January 2013). The extension studies (2012 and 2013 approvals) both showed an improvement in results disclosure within 12 months to 90%, and an overall disclosure rate of 92% and 93% respectively by the end of the studies. The methodology used was exactly as previously reported. Various publicly available information sources were searched for both clinical trial registration and disclosure of results. All completed company-sponsored trials related to each new medicine approved for marketing by the EMA in 2014, carried out in patients and recorded on a clinical trials registry and/or included in an EMA European Public Assessment Report (EPAR), were included. Information sources were searched between 1 May and 31 July 2016. The main outcome measure was the proportion of trials for which results had been disclosed on a registry or in the scientific literature either within 12 months of the later of either first regulatory approval or trial completion, or by 31 July 2016 (end of survey). Of the completed trials associated with 32 new medicines licensed to 22 different companies in 2014, results of 93% (505/542) had been disclosed within 12 months, and results of 96% (518/542) had been disclosed by 31 July 2016. The disclosure rate within 12 months of 93% suggests that industry is continuing to achieve disclosure in a timely manner. The overall disclosure rate at study end of 96% indicates that the improvement in transparency amongst company-sponsored trials has been maintained in the trials associated with new medicines approved in 2014.

The effect of exercise absence on affect and body dissatisfaction as moderated by obligatory exercise beliefs and eating disordered beliefs and behaviors

PubMed Central

LePage, Marie L.; Price, Matthew; O’Neil, Patrick; Crowther, Janis H.

2012-01-01

Aim Research suggests that exercise absence is frequently associated with greater guilt and negative affect, particularly when obligatory exercise beliefs and eating disordered psychopathology are considered. Two separate studies used ecological momentary assessment (EMA) to examine differences in mood on exercise and non-exercise days and the moderating impact of obligatory exercise beliefs and eating disordered beliefs and behaviors. Method Both studies recruited female university students who endorsed frequent exercise behavior and study two also recruited based on level of eating disordered psychopathology. Participants completed the Obligatory Exercise Questionnaire at baseline and EMA measures of affect and exercise behavior for approximately one week. Study two participants also completed measures of body dissatisfaction and cognitions. Results Results of study one suggest that obligation to exercise appears to have a greater impact on general level of affect than does exercise absence or the interaction of these two. In addition, in study two, eating disorder symptomatology was significantly associated with affect and cognition while exercise absence and obligatory exercise beliefs were not. Conclusions The present studies suggest that the absence of exercise is not associated with significant changes in affect or cognitions. However, obligation to exercise and eating disorder symptomatology do impact affect and cognitions. PMID:22930654

Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13.

PubMed

Davis, Courtney; Naci, Huseyin; Gurpinar, Evrim; Poplavska, Elita; Pinto, Ashlyn; Aggarwal, Ajay

2017-10-04

Objective  To determine the availability of data on overall survival and quality of life benefits of cancer drugs approved in Europe. Design  Retrospective cohort study. Setting  Publicly accessible regulatory and scientific reports on cancer approvals by the European Medicines Agency (EMA) from 2009 to 2013. Main outcome measures  Pivotal and postmarketing trials of cancer drugs according to their design features (randomisation, crossover, blinding), comparators, and endpoints. Availability and magnitude of benefit on overall survival or quality of life determined at time of approval and after market entry. Validated European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) used to assess the clinical value of the reported gains in published studies of cancer drugs. Results  From 2009 to 2013, the EMA approved the use of 48 cancer drugs for 68 indications. Of these, eight indications (12%) were approved on the basis of a single arm study. At the time of market approval, there was significant prolongation of survival in 24 of the 68 (35%). The magnitude of the benefit on overall survival ranged from 1.0 to 5.8 months (median 2.7 months). At the time of market approval, there was an improvement in quality of life in seven of 68 indications (10%). Out of 44 indications for which there was no evidence of a survival gain at the time of market authorisation, in the subsequent postmarketing period there was evidence for extension of life in three (7%) and reported benefit on quality of life in five (11%). Of the 68 cancer indications with EMA approval, and with a median of 5.4 years' follow-up (minimum 3.3 years, maximum 8.1 years), only 35 (51%) had shown a significant improvement in survival or quality of life, while 33 (49%) remained uncertain. Of 23 indications associated with a survival benefit that could be scored with the ESMO-MCBS tool, the benefit was judged to be clinically meaningful in less than half (11/23, 48%). Conclusions  This systematic evaluation of oncology approvals by the EMA in 2009-13 shows that most drugs entered the market without evidence of benefit on survival or quality of life. At a minimum of 3.3 years after market entry, there was still no conclusive evidence that these drugs either extended or improved life for most cancer indications. When there were survival gains over existing treatment options or placebo, they were often marginal. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Fibrosarcoma of the jaws: two cases of primary tumors with intraosseous growth.

PubMed

Angiero, Francesca; Rizzuti, Tommaso; Crippa, Rolando; Stefani, Michele

2007-01-01

Fibrosarcoma (FS) is a malignant mesenchymal neoplasm of the fibroblasts that rarely affects the oral cavity. Two cases of primary FS of the jaws with intraosseous growth (2 men, aged 53 and 71 years) are described. Microscopically, in one case the tumor showed an intense proliferation of spindle-shaped cells, varying little in size and shape and arranged in parallel bands, partly crossing each other, with significant mitotic activity and nuclear pleomorphism; the second case was characterized by low cellularity comprising spindle-shaped cells, deposited in a variably fibrous and myxoid stroma. On immunohistochemistry, cells in both cases were strongly immunoreactive for MIB-1 and vimentin, focally positive for CD68, and negative for S-100 protein, pancytokeratin, HMB45, CD34, desmin, smooth muscle actin (SMA) and epithelial membrane antigen (EMA). Based on clinical, histological and immunohistochemical findings, the final diagnosis was FS in the first case, myxofibrosarcoma in the second. Treatment was radical surgery with mandibular reconstruction. After two years, the first patient displayed multiple metastases and died during the third year after the initial diagnosis; the second patient was still alive and doing well five years after treatment. We discuss the differential diagnosis versus other forms of sarcoma, examining the morphological appearance that is frequently very similar, the immunohistochemical expression of MIB-1, vimentin, S-100, CD-34, CD68, EMA, as well as conventional clinicopathological features that may help to distinguish FS from other sarcomas.

AQUATIC STREAM INDICATOR DEVELOPMENT IN THE WESTERN UNITED STATES, PRELIMINARY RESULTS FOR ARIZONA, NEVADA, AND UTAH

EPA Science Inventory

Beginning in 1999, the U.S. Environmental Protection Agency initiated a 5-year study of streams and rivers in 12 western States (AZ, CA, CO, ID, MT, NV, ND, OR, SD, UT, WA, and V;Y) as a component of the Environmental Monitoring and Assessment Program (EMAP). The objective of EMA...

Preparation and photoluminescence properties of functionalized silica materials incorporating europium complexes

NASA Astrophysics Data System (ADS)

Lourenço, A. V. S.; Kodaira, C. A.; Souza, E. R.; Felinto, M. C. F. C.; Malta, O. L.; Brito, H. F.

2011-08-01

In the present work, the surface of the Eu-BTC = [Eu(EMA)(H 2O) 2], [Eu(TLA)(H 2O) 4] and [Eu(TMA)(H 2O) 6] complexes (EMA = 1,2,3-benzenetricarboxylate, TLA = 1,2,4-benzenetricarboxylate and TMA = 1,3,5-benzenetricarboxylate) was modified using 3-aminopropyltriethoxysilane (APTES) by a new microwave assisted method that proved to be simple and efficient. According to our observations, the most efficient luminescence is the material based on APTES incorporating [Eu(TMA)(H 2O) 6] complexes, denoted as Eu-TMA-Si, shows the highest emission efficiency. Therefore, it is proposed as a promising material for molecular conjugation in clinical diagnosis.

Histopathological and Immunohistochemical Evaluation of Pannus Tissue in Patients with Prosthetic Valve Dysfunction.

PubMed

Karakoyun, Süleyman; Ozan Gürsoy, Mustafa; Yesin, Mahmut; Kalçık, Macit; Astarcıoğlu, Mehmet Ali; Gündüz, Sabahattin; Emrah Oğuz, Ali; Çoban Kökten, Şermin; Nimet Karadayı, Ayşe; Tuncer, Altuğ; Köksal, Cengiz; Gökdeniz, Tayyar; Özkan, Mehmet

2016-01-01

Prosthetic valve dysfunction due to pannus formation is a rare but serious complication. Currently, limited data are available concerning the pathogenesis and immunohistochemical properties of pannus. The study aim was to investigate the morphological, histopathological and immunohistochemical characteristics of pannus formation in patients with prosthetic valve dysfunction. A total of 35 patients (10 males, 25 females; mean age 44 ± 16 years) who had undergone re-do valve surgery due to prosthetic valve obstruction was enrolled in the study. Immunohistochemical studies were aimed at evaluating the expression of alphasmooth muscle actin (α-SMA) and desmin in myofibroblasts and smooth muscle cells; epithelial membrane antigen (EMA) in epithelial cells; and CD34, Factor VIII and vascular endothelial growth factor (VEGF) in endothelial cells. Matrix metalloproteinases (MMPs) -2 and -9, and transforming growth factor-beta (TGF-β) were used to demonstrate cytokine release from macrophages, leukocytes, fibroblasts and myofibroblasts. Pannus appeared as a tough and thick tissue hyperplasia which began from outside the suture ring in the periannular region and extended to the inflow and outflow surfaces of the prosthetic valves. Histopathological analysis showed the pannus tissue to consist of chronic inflammatory cells (lymphocytes, plasma cells, macrophages and foreign body giant cells), spindle cells such as myofibroblasts, capillary blood vessels and endothelial cells laying down the lumens. Calcification was present in the pannus tissue of 19 explanted prostheses. Immunohistochemical studies revealed positive α-SMA expression in all patients, whereas 60.5% of patients were positive for desmin, 50% for EMA, 42.1% for VEGF, 39.5% for TBF-β, 42.1% for MMP-2, 86.8% for CD34, and 97.4% for Factor VIII. MMP-9 was negative in all patients. Pannus tissue appears to be formed as the result of a neointimal response in periannular regions of prosthetic valves that consist of periannular tissue migration, myofibroblast and extracellular matrix proliferation with vascular components. It is a chronic active process in which mediators such as TGF-β, VEGF and MMP-2 play roles in both matrix formation and degradation.

Nuclear fluorescence serum reactivity on monkey oesophagus: a new antibody for the follow-up of coeliac disease?

PubMed

Picarelli, A; Sabbatella, L; Di Tola, M; Silano, M; Nicolussi, A; D'Inzeo, S; Coppa, A

2010-09-01

We have identified previously a nuclear fluorescence reactivity (NFR) pattern on monkey oesophagus sections exposed to coeliac disease (CD) patients' sera positive for anti-endomysium antibodies (EMA). The aim of the present work was to characterize the NFR, study the time-course of NFR-positive results in relation to gluten withdrawal and evaluate the potential role of NFR in the follow-up of CD. Twenty untreated, 87 treated CD patients and 15 healthy controls were recruited and followed for 12 months. Their sera were incubated on monkey oesophagus sections to evaluate the presence of NFR by indirect immunofluorescence analysis. Duodenal mucosa samples from treated CD patients were challenged with gliadin peptides, and thus the occurrence of NFR in culture supernatants was assessed. The NFR immunoglobulins (Igs) reactivity with the nuclear extract of a human intestinal cell line was investigated. Serum NFR was present in all untreated CD patients, persisted up to 151 ± 37 days from gluten withdrawal and reappeared in treated CD patients under dietary transgressions. Serum NFR was also detected in two healthy controls. In culture supernatants of coeliac intestinal mucosa challenged with gliadin peptides, NFR appeared before EMA. The Igs responsible for NFR were identified as belonging to the IgA2 subclass. The NFR resulted differently from EMA and anti-nuclear antibodies, but reacted with two nuclear antigens of 65 and 49 kDa. A new autoantibody, named NFR related to CD, was described. Furthermore, NFR detection might become a valuable tool in monitoring adherence to a gluten-free diet and identifying slight dietary transgressions. © 2010 British Society for Immunology.

Effect of Brief Mindfulness Practice on Self-Reported Affect, Craving, and Smoking: A Pilot Randomized Controlled Trial Using Ecological Momentary Assessment.

PubMed

Ruscio, Aimee C; Muench, Christine; Brede, Emily; Waters, Andrew J

2016-01-01

Despite efficacious pharmacological and behavioral treatments, most smokers attempt to quit without assistance and fail to quit. Mindfulness practice may be useful in smoking cessation. This ecological momentary assessment (EMA) study was a pilot parallel group randomized controlled trial of a brief mindfulness practice (Brief-MP) intervention on self-reported smoking behavior delivered to smokers on a Personal Digital Assistant (PDA) in the field. Adult community smokers (N = 44) were randomly assigned to a Brief-MP (n = 24) or Control (sham meditation; n = 20) group. Participants were instructed to smoke as much or as little as they liked. Participants carried a PDA for 2 weeks and were instructed to initiate 20 minutes of meditation (or control) training on the PDA daily, completing an assessment of cognitive and affective processes immediately afterwards. Additionally, they completed assessments at random times up to four times per day. Primary outcome variables were negative affect, craving, and cigarettes smoked per day, all self-reported. Thirty-seven participants provided EMA data totaling 1874 assessments. Linear Mixed Model analyses on EMA data revealed that Brief-MP (vs. Control) reduced overall negative affect, F(1, 1798) = 13.8, P = .0002; reduced craving immediately post-meditation, (Group × Assessment Type interaction, F(2, 1796) = 12.3, P = .0001); and reduced cigarettes smoked per day over time (Group × Day interaction, F(1, 436) = 5.50, P = .01). Brief-MP administered in the field reduced negative affect, craving, and cigarette use, suggesting it may be a useful treatment. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco 2015. This work is written by (a) US Government employee(s) and is in the public domain in the US.

Feasibility and acceptability of a mobile app in an ecological momentary assessment of early breastfeeding.

PubMed

Demirci, Jill R; Bogen, Debra L

2017-07-01

Ecological momentary assessment (EMA) is a novel data collection method that samples subject experiences in real-time - minimizing recall bias. Here, we describe the feasibility of EMA to track breastfeeding behaviour through a mobile phone app. During their birth hospitalization, we approached healthy, first-time mothers intending to exclusively breastfeed for at least 2 months to participate in a study tracking breastfeeding through 8 weeks postpartum. Participants downloaded a commercially available smartphone app, entered information and thoughts about breastfeeding as they occurred, and emailed this data weekly. We called participants at 2 and 8 weeks to assess breastfeeding status. At the 8-week call, we also assessed participants' experiences using the app. Of the 61 participants, 38% sent complete or nearly complete feeding data, 24% sent some data, and 38% sent no data; 58% completed at least one free-text breastfeeding entry, and five women logged daily or near daily entries. Compared with women who sent no data, those who sent any were more likely to be married, highly educated, intend to breastfeed more than 6 months, have a more favourable baseline attitude towards breastfeeding, and less likely to have used formula during hospitalization. There was a high degree of agreement between participant-reported proportion of breast milk feeds via app and interview data at 2 weeks (ICC 0.97). Experiences with the app ranged from helpful to too time-consuming or anxiety-provoking. Participants and researchers encountered technical issues related to app use and analysis, respectively. While our data do not support the feasibility of stand-alone app-based EMA to track breastfeeding behaviour, it may provide rich accounts of the breastfeeding experience for certain subgroups of women. © 2016 John Wiley & Sons Ltd. © 2016 John Wiley & Sons Ltd.

Concurrent and Predictive Associations between Early Adolescent Perceptions of Peer Affiliates and Mood States Collected in Real Time via Ecological Momentary Assessment Methodology

PubMed Central

Rusby, Julie C.; Westling, Erika; Crowley, Ryann; Light, John M.

2013-01-01

This study uses Ecological Momentary Assessment (EMA) to simultaneously capture youths’ perceptions of peer affiliates and social contexts to determine their association with youths’ current and future mood states. A sample of 82 seventh grade students (36 at risk for developing or escalating rule-breaking and substance use, and 46 randomly selected) from four schools participated. Utilizing EMA methodology students reported on their peer affiliations, perceptions of peer affiliates, moods, activities, location, and behaviors during their free time. Data from three assessment waves were collected; each wave consisted of 27 randomly prompted assessments during a week. Youth spent a large portion of their free time watching T.V., on the computer, or playing video games. Being “out and about” increased over the school year, whereas adult supervision decreased, showing an increase in potentially risky situations. Happiness was associated with affiliating with peers who were perceived as popular. Negative moods were associated with affiliating with peers by whom they are teased or treated meanly. Multilevel models found that both levels and lability of negative moods (i.e., sadness, anxiety) were predicted by risk status and affiliating with peers who tease them. Compared to boys, girls who affiliated more with peers who teased them and were classified as at-risk had more extreme negative moods and negative mood lability. EMA methodology has demonstrated the ways in which salient intrapersonal and peer processes are associated over time, which can inform efforts to prevent the development and escalation of behavior problems, substance use, and mood disorders in youth. PMID:23088201

Modeling relative permeability of water in soil: Application of effective-medium approximation and percolation theory

NASA Astrophysics Data System (ADS)

Ghanbarian, Behzad; Sahimi, Muhammad; Daigle, Hugh

2016-07-01

Accurate prediction of the relative permeability to water under partially saturated condition has broad applications and has been studied intensively since the 1940s by petroleum, chemical, and civil engineers, as well as hydrologists and soil scientists. Many models have been developed for this purpose, ranging from those that represent the pore space as a bundle of capillary tubes, to those that utilize complex networks of interconnected pore bodies and pore throats with various cross-section shapes. In this paper, we propose an approach based on the effective-medium approximation (EMA) and percolation theory in order to predict the water relative permeability. The approach is general and applicable to any type of porous media. We use the method to compute the water relative permeability in porous media whose pore-size distribution follows a power law. The EMA is invoked to predict the relative permeability from the fully saturated pore space to some intermediate water saturation that represents a crossover from the EMA to what we refer to as the "critical region." In the critical region below the crossover water saturation Swx, but still above the critical water saturation Swc (the residual saturation or the percolation threshold of the water phase), the universal power law predicted by percolation theory is used to compute the relative permeability. To evaluate the accuracy of the approach, data for 21 sets of undisturbed laboratory samples were selected from the UNSODA database. For 14 cases, the predicted relative permeabilities are in good agreement with the data. For the remaining seven samples, however, the theory underestimates the relative permeabilities. Some plausible sources of the discrepancy are discussed.

A response surface analysis of expected and received support for smoking cessation: Expectancy violations predict greater relapse.

PubMed

Derrick, Jaye L; Britton, Maggie; Baker, Zachary G; Haddad, Sana

2018-08-01

People attempting to stop smoking cigarettes (quitters) hold expectations about the extent to which their partner will provide helpful support during a quit attempt. However, these expectations may not align with their perceptions of the helpfulness of the support they receive. We examine expected and received helpful support during a quit attempt. We hypothesized that receiving less helpful support than expected (i.e., creating an expectancy violation) would be associated with the greatest return to smoking. Sixty-two quitters completed a 21-day ecological momentary assessment (EMA) study. They reported expected support at baseline and support receipt and smoking during the EMA phase. At follow-up, they completed an expelled breath carbon monoxide test. Analyses using polynomial generalized linear models with response surface analysis indicated that smoking outcomes depended on the joint influence of expected and received helpful support. As hypothesized, when quitters expected more helpful support than they received, they were more likely to smoke in the first 24h and the last seven days of the EMA, and they provided higher carbon monoxide readings at follow-up. These results are consistent with an expectancy violation explanation: quitters are more likely to smoke when they perceive their partner has failed to provide support that is as helpful as expected. Given the importance of support for smoking cessation, many researchers have attempted to experimentally increase provision of support. The current findings suggest that partner support interventions might backfire if the quitter is led to expect more helpful support than the partner is able to provide. Copyright © 2018 Elsevier Ltd. All rights reserved.

Effect of high oxygen modified atmosphere packaging on microbial growth and sensorial qualities of fresh-cut produce.

PubMed

Jacxsens, L; Devlieghere, F; Van der Steen, C; Debevere, J

2001-12-30

The application of High Oxygen Atmospheres (HOA) (i.e. > 70% O2) for packaging ready-to-eat vegetables was evaluated as an alternative technique for low O2 Equilibrium Modified Atmosphere (EMA) packaging (3% O2-5% CO2-balance N2) for respiring products. Comparative experiments between both techniques were performed in-vitro and in-vivo. Typical spoilage causing microorganisms (Pseudomonas fluorescens, Candida lambica), the moulds Botrytis cinerea, Aspergillus flavus and the opportunistic psychrotrophic human pathogenic microorganism associated with refrigerated minimally processed vegetables. Aeromonas caviae (HG4), showed a retarded growth during the conducted in-vitro studies at 4 degrees C in 70%, 80% and 95% O2 as examples of HOA compared to the in-vitro experiments in 5% O2 (as example of EMA packaging) and the effect was more pronounced in 95% O2. The effect of the high O2-concentrations on the human pathogen Listeria monocytogenes resulted in an extended lag phase (95% O2). The plant pathogen Erwinia carotovora was increasingly stimulated by increasing high O2-concentrations. During a storage experiment of three types of ready-to-eat vegetables (mushroom slices, grated celeriac and shredded chicory endive), which are sensitive to enzymatic browning and microbial spoilage, the effect of EMA and HOA (95% O2-5% N2) on their quality and shelf life was compared. High O2 atmospheres were found to be particularly effective in inhibiting enzymatic browning of the tested vegetables. Also, the microbial quality was better as a reduction in yeast growth was observed. The HOA can be applied as an alternative for low O2 modified atmospheres for some specific types of ready-to-eat vegetables, sensitive to enzymatic browning and spoilage by yeasts.

Regulatory/Scientific Supports for Micro-, Small-, and Medium-Sized Enterprises (SMEs) With Medicinal Products Provided by the PMDA and EMA.

PubMed

Kondo, Hideyuki; Shibatsuji, Masayoshi; Yasuda, Naoyuki

2018-01-01

Micro-, small-, and medium-sized enterprises (SMEs) have been considered as key players who can bring innovative medicinal products and/or technologies into the field. However, they may need much regulatory/scientific supports to provide their products, technologies, or services to the market in a timely way. Both the Pharmaceuticals and Medical Devices Agency (PMDA) and the European Medicines Agency (EMA), regulatory authorities for medicinal products in Japan and the EU, respectively, have prepared supportive measures for SMEs from the early phase of product/technology development to the postmarketing phase. With respect to supports for SMEs, both agencies have provided similar SME-specific supportive activities, including routine administrative assistance, consultations about product development strategy from an early phase, as well as specific regulatory/scientific issues and fee incentives. In addition, there is a system to register SME status in the EU, which can be a tool for regulators to know how much potential SME-driven activities have and with whom they should communicate to provide necessary supports. Furthermore, as new technologies and novel products from SMEs are not limited to the region where they are developed, close communication about these topics between the PMDA and the EMA will contribute to advancing patients' access to necessary medicinal products.

New Developments in the Prophylactic Drug Treatment of Pediatric Migraine: What Is New in 2017 and Where Does It Leave Us?

PubMed

Kacperski, Joanne; Bazarsky, Allyson

2017-08-01

Headaches in children are quite common; however, the study and characterization of headache disorders in the pediatric age group has historically been limited. Because of the lack of controlled studies on prophylactic treatment of headache disorders in this age group, the diagnosis of migraine rests on criteria similar those in adults. Likewise, data from adult studies is often inferred and applied to children. Although it appears that many preventives are safe in children, currently none are FDA or EMA approved for this age group. Consequently, many children who present to their primary care physicians with migraines do not receive any preventive therapy despite experiencing significant disability. Controlled clinical trials investigating the use of preventive medications in children have suffered from high placebo response rates. The shorter duration of headaches and other characteristic features seen in children are such that designing randomized controlled trials in this age group is more problematic and limiting. Treatment practices vary widely, even among specialists, due to the absence of evidence-based guidelines from clinical trials. The Childhood and Adolescent Migraine Prevention Study (CHAMP) was developed to examine the effectiveness of two of the most widely prescribed preventive medications for pediatric migraine and help narrow this gap. To date, it has been the largest enrolling study of its kind within the pediatric migraine world; its results and implications will be discussed and considered here. The CHAMP trial was discontinued early on account of futility and exhibited that neither of two preventive medications for pediatric migraine was more effective than placebo in reducing the number of headache days over a period of 24 weeks. Subjects in the amitriptyline and topiramate groups had higher rates of adverse events than those who had received placebo.

How Data Packages Lacking Phase III Pivotal Trial Data Can Support Regulatory Approval and Reimbursement for Oncologics in Australia.

PubMed

Macaulay, Richard; Siddiqui, Mohammad Kashif; Stoddart, Samuel

2015-05-01

Oncology drugs lacking supportive phase III trial data have achieved Food and Drug Administration (FDA) and European Medicines Agency (EMA) regulatory approval and even European reimbursement approval where no therapeutic alternative exists and early-stage data indicate dramatic clinical benefits. This research aimed to compare under what circumstances oncologics can obtain both regulatory and reimbursement approval in Australia on this basis. Therapeutic Goods Administration (TGA) Australian Public Assessment Reports, EMA, FDA, and Pharmaceutical Benefits Advisory Committee (PBAC) Public Summary Documents were extracted for any oncologic indication appraised in Australia on a pivotal trial package lacking phase III data, excluding pediatric indications and new formulations. Australian Public Assessment Reports were available for six TGA-appraised oncologics across seven indications on such a data package: five of seven approved, one of seven restricted, and one of seven rejected. The EMA and the FDA issued recommendations on these indications an average of 1 and 2 years earlier, respectively. The PBAC appraised six oncologics across 10 indications on such a data package, with four (nilotinib, dasatinib, imatinib, and brentuximab vedotin) approved and two rejected (cetuximab and bevacizumab). Seven of the eight approved indications required multiple submissions, with inadequate clinical data frequently cited as key. Six of the eight PBAC-approved indications included economic modeling on a cost-benefit approach. The TGA will approve oncologics that offer potentially substantial clinical benefits on the basis of an indirect comparison of single-arm trials but at a delay versus the EMA and the FDA. The PBAC reimbursement approval also requires more rigorous supportive clinical data and acceptable cost-effectiveness as demonstrated on a cost-benefit or cost-quality-adjusted life-year metric. Copyright © 2015 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Frequency of awake bruxism behaviours in the natural environment. A 7-day, multiple-point observation of real-time report in healthy young adults.

PubMed

Bracci, A; Djukic, G; Favero, L; Salmaso, L; Guarda-Nardini, L; Manfredini, D

2018-06-01

The aim of this study was to assess awake bruxism (AB) behaviours in a sample of healthy young adults using a smartphone-based application for a real-time report (ie, ecological momentary assessment [EMA], also called experience sampling method [ESM]). Forty-six dental students used a smartphone application that sent 15 alerts at random intervals during the day for 1 week to collect AB self-reports. They had to answer on time by tapping on the display icon that refers to their current condition of jaw muscles: relaxed; teeth contact; teeth clenching; teeth grinding; jaw clenching without teeth contact (ie, bracing). The average frequency of relaxed jaw muscles, as a percentage of answers over the 7 days, was 71.7%. Teeth contact (14.5%) and jaw clenching (10.0%) were the most frequent AB behaviours. No significant gender differences were detected. Interindividual differences were quite relevant, but the overall frequency was in general only moderately variable from day-to-day. Coefficient of variation (CV) was low for the condition "relaxed jaw muscles" (0.44). At the individual level, teeth contact was the most prevalent behaviour, with a 39.1%-52.2% proportion of subjects reporting it at least once a day. During a 7-day observation period, the frequency of real-time report of AB behaviours in a sample of healthy young adults was 28.3%. The low daily variability in the average frequency value for the relaxed jaw muscles condition suggests that EMA may be a reliable strategy to get deeper into the epidemiology of oral behaviours. This investigation introduced EMA principles to the study of AB and provided data on the frequency of AB behaviours in young adults that could be compared to populations with risk/associated factors and possible clinical consequences. © 2018 John Wiley & Sons Ltd.

Advancing Cessation Research by Integrating EMA and Geospatial Methodologies: Associations Between Tobacco Retail Outlets and Real-time Smoking Urges During a Quit Attempt

PubMed Central

2014-01-01

Introduction: Residential tobacco retail outlet (TRO) density and proximity have been associated with smoking behaviors. More research is needed to understand the mechanisms underlying these relations and their potential relevance outside of the residential setting. This study integrates ecological momentary assessment (EMA) and geo-location tracking to explore real-time associations between exposure to TROs and smoking urges among 47 economically disadvantaged smokers in a cessation trial (59.6% female; 36.2% White). Methods: EMA data were collected for 1 week postquit via smartphone, which recorded smoking urge strength ≤4 random times daily along with real-time participant location data. For each assessment, the participants’ proximity to the closest TRO and the density of TROs surrounding the participant were calculated. Linear mixed model regressions examined associations between TRO variables and smoking urges and whether relations varied based on participants’ distance from their home. Covariates included sociodemographics, prequit tobacco dependence, treatment group, and daily smoking status. Results: Main effects were nonsignificant; however, the interaction between TRO proximity and distance from home was considered significant (p = .056). Specifically, closer proximity to TROs was associated with stronger smoking urges ≤1 mile of home (p = .001) but not >1 mile from home (p = .307). Significant associations were attributable to assessments completed at participants’ home addresses. All density analyses were nonsignificant. Conclusions: Technological challenges encountered in this study resulted in a significant amount of missing data, highlighting the preliminary nature of these findings and limiting the inferences that can be drawn. However, results suggest that closer residential proximity to tobacco outlets may trigger stronger urges to smoke among economically disadvantaged smokers trying to quit, perhaps due to enhanced cigarette availability and accessibility. Therefore, limiting tobacco sales in close proximity to residential areas may complement existing tobacco control efforts and facilitate cessation. PMID:24057995

Advancing cessation research by integrating EMA and geospatial methodologies: associations between tobacco retail outlets and real-time smoking urges during a quit attempt.

PubMed

Watkins, Kellie L; Regan, Seann D; Nguyen, Nga; Businelle, Michael S; Kendzor, Darla E; Lam, Cho; Balis, David; Cuevas, Adolfo G; Cao, Yumei; Reitzel, Lorraine R

2014-05-01

Residential tobacco retail outlet (TRO) density and proximity have been associated with smoking behaviors. More research is needed to understand the mechanisms underlying these relations and their potential relevance outside of the residential setting. This study integrates ecological momentary assessment (EMA) and geo-location tracking to explore real-time associations between exposure to TROs and smoking urges among 47 economically disadvantaged smokers in a cessation trial (59.6% female; 36.2% White). EMA data were collected for 1 week postquit via smartphone, which recorded smoking urge strength ≤ 4 random times daily along with real-time participant location data. For each assessment, the participants' proximity to the closest TRO and the density of TROs surrounding the participant were calculated. Linear mixed model regressions examined associations between TRO variables and smoking urges and whether relations varied based on participants' distance from their home. Covariates included sociodemographics, prequit tobacco dependence, treatment group, and daily smoking status. Main effects were nonsignificant; however, the interaction between TRO proximity and distance from home was considered significant (p = .056). Specifically, closer proximity to TROs was associated with stronger smoking urges ≤ 1 mile of home (p = .001) but not >1 mile from home (p = .307). Significant associations were attributable to assessments completed at participants' home addresses. All density analyses were nonsignificant. Technological challenges encountered in this study resulted in a significant amount of missing data, highlighting the preliminary nature of these findings and limiting the inferences that can be drawn. However, results suggest that closer residential proximity to tobacco outlets may trigger stronger urges to smoke among economically disadvantaged smokers trying to quit, perhaps due to enhanced cigarette availability and accessibility. Therefore, limiting tobacco sales in close proximity to residential areas may complement existing tobacco control efforts and facilitate cessation.

Mobile Phone Ownership Is Not a Serious Barrier to Participation in Studies: Descriptive Study

PubMed Central

Rubin, Leslie F; Smiley, Sabrina L; Zhou, Yitong; Elmasry, Hoda; Pearson, Jennifer L

2018-01-01

Background Rather than providing participants with study-specific data collection devices, their personal mobile phones are increasingly being used as a means for collecting geolocation and ecological momentary assessment (EMA) data in public health research. Objective The purpose of this study was to (1) describe the sociodemographic characteristics of respondents to an online survey screener assessing eligibility to participate in a mixed methods study collecting geolocation and EMA data via the participants’ personal mobile phones, and (2) examine how eligibility criteria requiring mobile phone ownership and an unlimited text messaging plan affected participant inclusion. Methods Adult (≥18 years) daily smokers were recruited via public advertisements, free weekly newspapers, printed flyers, and word of mouth. An online survey screener was used as the initial method of determining eligibility for study participation. The survey screened for twenty-eight inclusion criteria grouped into three categories, which included (1) cell phone use, (2) tobacco use, and (3) additional criteria Results A total of 1003 individuals completed the online screener. Respondents were predominantly African American (605/1003, 60.3%) (60.4%), male (514/1003, 51.3%), and had a median age of 35 years (IQR 26-50). Nearly 50% (496/1003, 49.5%) were unemployed. Most smoked menthol cigarettes (699/1003, 69.7%), and had a median smoking history of 11 years (IQR 5-21). The majority owned a mobile phone (739/1003, 73.7%), could install apps (86.8%), used their mobile phone daily (89.5%), and had an unlimited text messaging plan (871/1003, 86.8%). Of those who completed the online screener, 302 were eligible to participate in the study; 163 were eligible after rescreening, and 117 were enrolled in the study. Compared to employed individuals, a significantly greater proportion of those who were unemployed were ineligible for the study based on mobile phone inclusion criteria (P<.001); yet, 46.4% (333/717) of the individuals who were unemployed met all mobile phone inclusion criteria. Conclusions Inclusion criteria requiring participants to use their personal mobile phones for data collection was not a major barrier to study participation for most respondents who completed the online screener, including those who were unemployed. Trial Registration ClinicalTrials.gov NCT02261363; https://clinicaltrials.gov/ct2/show/NCT02261363 (Archived by WebCite at http://www.webcitation.org/6wOmDluSt) PMID:29459355

The feasibility of cell phone based electronic diaries for STI/HIV research.

PubMed

Hensel, Devon J; Fortenberry, James D; Harezlak, Jaroslaw; Craig, Dorothy

2012-06-12

Self-reports of sensitive, socially stigmatized or illegal behavior are common in STI/HIV research, but can raise challenges in terms of data reliability and validity. The use of electronic data collection tools, including ecological momentary assessment (EMA), can increase the accuracy of this information by allowing a participant to self-administer a survey or diary entry, in their own environment, as close to the occurrence of the behavior as possible. In this paper, we evaluate the feasibility of using cell phone-based EMA as a tool for understanding sexual risk and STI among adult men and women. As part of a larger prospective clinical study on sexual risk behavior and incident STI in clinically recruited adult men and women, using study-provided cell phones, participants (N = 243) completed thrice-daily EMA diaries monitoring individual and partner-specific emotional attributes, non-sexual activities, non-coital or coital sexual behaviors, and contraceptive behaviors. Using these data, we assess feasibility in terms of participant compliance, behavior reactivity, general method acceptability and method efficacy for capturing behaviors. Participants were highly compliant with diary entry protocol and schedule: over the entire 12 study weeks, participants submitted 89.7% (54,914/61,236) of the expected diary entries, with an average of 18.86 of the 21 expected diaries (85.7%) each week. Submission did not differ substantially across gender, race/ethnicity and baseline sexually transmitted infection status. A sufficient volume and range of sexual behaviors were captured, with reporting trends in different legal and illegal behaviors showing small variation over time. Participants found the methodology to be acceptable, enjoyed and felt comfortable participating in the study. Achieving the correct medium of data collection can drastically improve, or degrade, the timeliness and quality of an individual's self-reported sexual risk behavior, which in turn, is a key factor in the success of intervention or education programs relying on this information. Our findings demonstrate that completion of electronic diaries via cellular phone is feasible way to describe STI/HIV risk among clinically recruited adult men and women.

The production of the oral mucosa of antiendomysial and anti-tissue-transglutaminase antibodies in patients with celiac disease: a review.

PubMed

Compilato, Domenico; Campisi, Giuseppina; Pastore, Luca; Carroccio, Antonio

2010-12-14

Celiac disease (CD) is a lifelong, T cell-mediated enteropathy, triggered by the ingestion of gluten and related prolamins in genetically susceptible subjects, resulting in minor intestinal mucosal injury, including villous atrophy with crypt hyperplasia and intraepithelial lymphocytosis, and subsequent nutrient malabsorption. Although serological tests for antiendomysial (EMA) and anti-tissue transglutaminase (anti-tTG) autoantibodies are used to screen and follow up on patients with CD, diagnostic confirmation is still based on the histological examination of the small intestinal mucosa. Although the small intestinal mucosa is the main site of the gut involved in CD, other mucosal surfaces (such as gastric, rectal, ileal, and esophageal) belonging to the gastrointestinal tract and the gut-associated lymphoid tissue (GALT) can also be involved. A site that could be studied less invasively is the mouth, as it is the first part of the gastrointestinal system and a part of the GALT. Indeed, not only have various oral ailments been reported as possible atypical aspects of CD, but it has been also demonstrated that inflammatory changes occur after oral supramucosal application and a submucosal injection of gliadin into the oral mucosa of CD patients. However, to date, only two studies have assessed the capacity of the oral mucosa of untreated CD patients to EMA and anti-tTG antibodies. In this paper, we will review studies that evaluate the capacity of the oral mucosa to produce specific CD autoantibodies. Discrepancies in sensitivity from the two studies have revealed that biopsy is still not an adequate procedure for the routine diagnostic purposes of CD patients, and a more in-depth evaluation on a larger sample size with standardized collection and analysis methods is merited. However, the demonstration of immunological reactivity to the gluten ingestion of the oral mucosa of CD, in terms of IgA EMA and anti-tTG production, needs to be further evaluated in order to verify whether the oral mucosa is colonized by lymphocytes activated in the intestine or if gluten could stimulate naïve lymphocytes directly in the oral mucosa. This would have important implications for the pathogenesis, diagnosis, and treatment of CD.

Approval of the first biosimilar antibodies in Europe: a major landmark for the biopharmaceutical industry.

PubMed

Beck, Alain; Reichert, Janice M

2013-01-01

In a defining moment for the European Medicines Agency (EMA) and the biopharmaceutical industry, on June 27, 2013 EMA's Committee for Medicinal Products for Human Use adopted a positive opinion for two biosimilar infliximab products (Celltrion's Remsima® and Hospira's Inflectra®), and recommended that they be approved for marketing in the European Union (EU). The European Commission's decision on an application is typically issued 67 d after an opinion is provided; thus, decisions are expected in early September 2013. If approved, the products will comprise the first biosimilar antibody made available to patients in a highly regulated market, although launch may be delayed due to an extension of the reference product's (Remicade®) patent in the EU.

The concept of apparent polarizability for calculating the extinction of electromagnetic radiation by porous aerosol particles

NASA Astrophysics Data System (ADS)

Haspel, C.; Adler, G.

2017-04-01

In the current study, the electromagnetic properties of porous aerosol particles are calculated in two ways. In the first, a porous target input file is generated by carving out voids in an otherwise homogeneous particle, and the discrete dipole approximation (DDA) is used to compute the extinction efficiency of the particle assuming that the voids are near vacuum dielectrics and assuming random particle orientation. In the second, an effective medium approximation (EMA) style approach is employed in which an apparent polarizability of the voids is defined based on the well-known solution to the problem in classical electrostatics of a spherical cavity within a dielectric. It is found that for porous particles with smaller overall diameter with respect to the wavelength of incident radiation, describing the voids as near vacuum dielectrics within the DDA sufficiently reproduces measured values of extinction efficiency, whereas for porous particles with moderate to larger overall diameters with respect to the wavelength of the radiation, the apparent polarizability EMA approach better reproduces the measured values of extinction efficiency.

The effect of the European traditional use directive on the register of herbal medicinal products in Spain.

PubMed

Tejedor-García, Noelia; García-Pastor, Coral; Navalmoral-Arenas, Estefanía; Blas-Espada, Javier; Madrigal-Martínez, Antonio; de Lucio-Cazaña, Francisco Javier

2015-01-01

Directive 2004/24/EC, which came into force in 2011, created new regulatory requirements for traditional herbal medicines (THM). This study compared the Spanish THM registry before and after the Directive came fully into force in 2011. We consulted the herbal medicinal plant and drug catalogues (General Council of the Official Colleges of Pharmacists), the website of the European Medicines Agency (EMA), and retail web sites. Of 315 THM (from 39 companies) licensed in Spain in 2010, only 48 (10 companies) remained licensed in 2013, mainly due to their withdrawal: the EMA had received just 123 applications from Spain and at least 34% formerly licensed THM had shifted to the less strictly regulated food sector, while up to 54% might have disappeared from the market. However, there is still a significant presence of retail websites making illegal health claims. In Spain, the public health benefits of the Directive 2004/24/EC might be less than expected. Copyright © 2014 SESPAS. Published by Elsevier Espana. All rights reserved.

Survey of international regulatory bioequivalence recommendations for approval of generic topical dermatological drug products.

PubMed

Braddy, April C; Davit, Barbara M; Stier, Ethan M; Conner, Dale P

2015-01-01

The objective of this article is to discuss the similarities and differences in accepted bioequivalence (BE) approaches for generic topical dermatological drug products between international regulatory authorities and organizations. These drug products are locally applied and not intended for systemic absorption. Therefore, the BE approaches which serve as surrogates to establish safety and efficacy for topical dosage forms tend to differ from the traditional solid oral dosage forms. We focused on 15 different international jurisdictions and organizations that currently participate in the International Generic Drug Regulators Pilot Project. These are Australia, Brazil, Canada, China, Chinese Taipei, the European Medicines Association (EMA), Japan, Mexico, New Zealand, Singapore (a member of the Association of Southeast Asian Nations), South Africa, South Korea, Switzerland, the USA and the World Health Organization (WHO). Upon evaluation, we observed that currently only Canada, the EMA, Japan, and the USA have specific guidance documents for topical drug products. Across all jurisdictions and organizations, the three approaches consistently required are (1) BE studies with clinical endpoints for most topical drug products; (2) in vivo pharmacodynamic studies, in particular the vasoconstrictor assay for topical corticosteroids; and (3) waivers from BE study requirements for topical solutions. Japan, South Africa, the USA, and the WHO are also making strides to accept other BE approaches such as in vivo pharmacokinetic studies for BE assessment, in vivo dermatopharmacokinetic studies and/or BE studies with in vitro endpoints.

Germ cell tumour growth patterns originating from clear cell carcinomas of the ovary and endometrium: a comparative immunohistochemical study favouring their origin from somatic stem cells.

PubMed

Nogales, Francisco F; Prat, Jaime; Schuldt, Maolly; Cruz-Viruel, Nelly; Kaur, Baljeet; D'Angelo, Emanuela; Matias-Guiu, Xavier; Vidal, August; McCluggage, W Glenn; Oosterhuis, J Wolter

2018-03-01

To report a series of 11 ovarian and one endometrial neoplasm in elderly patients with mixed clear cell tumour and germ cell tumour (GCT) components, to compare their immunohistochemical profiles and demonstrate a putative stem cell population. The clear cell tumours included 11 clear cell carcinomas (CCC) and one borderline clear cell tumour, while the GCT always included glandular yolk sac tumour (YST). In four cases, there were also foci of teratoma with immature neuroepithelial and endodermal tissues and undifferentiated areas showing true embryoids. To distinguish between the clear cell and YST components, the following antibodies were used: HNF1-β, napsin-A, cytokeratin 7 (CK7), PAX8, EMA, AFP, SALL4, villin, glypican-3 (GPC-3), GATA3, HepPar-1, OCT4, CDX2, CD30 and SOX2. HNF1-β, CK7, EMA and GPC-3 were often expressed in both components. Other markers had higher specificity for each cellular lineage; napsin-A and PAX8 were expressed only in CCC, while SALL4, villin, AFP and HepPar-1 were positive in the glandular YST component but negative in the clear cell component. OCT4 expression occurred in six of 10 cases and consistently in teratoma (four of four). There is considerable immunophenotypical overlap between the two components in these mixed neoplasms, and a panel of markers should be used to facilitate the distinction. We propose that OCT4-expressing somatic cancer cells differentiate into GCT and represent spontaneously induced pluripotent stem cells, possibly conditioned by age-related epigenetic factors. These neoplasms have features of prepubertal type GCT showing lack of 12p gain, preponderance of YST and coexistence with immature neuroectoderm. However, there may also be undifferentiated stem cell areas with embryoid bodies, of the type seen in postpubertal testicular GCT, but lacking a complete embryonal carcinoma immunophenotype. © 2017 John Wiley & Sons Ltd.

Predictors of lapse in first week of smoking abstinence in PTSD and non-PTSD smokers.

PubMed

Beckham, Jean C; Calhoun, Patrick S; Dennis, Michelle F; Wilson, Sarah M; Dedert, Eric A

2013-06-01

Retrospective research suggests smokers with posttraumatic stress disorder (PTSD) lapse more quickly after their quit date. Ecological momentary assessment (EMA) research is needed to confirm the presence of early smoking lapse in PTSD and form conceptualizations that inform intervention. Smokers with (n = 55) and without (n = 52) PTSD completed alarm-prompted EMA of situational and psychiatric variables the week before and after a quit date, and self-initiated EMA following smoking lapses. Blood samples at baseline and on the quit date allowed assessment of dehydroepiandrosterone (DHEA) and dehydroepiandrosterone sulfate (DHEA(S)). PTSD was related to shorter time to lapse (hazard ratio [HR] = 1.677, 95% CI: 1.106-2.544). Increased smoking abstinence self-efficacy was related to longer time to lapse (HR = 0.608, 95% CI: 0.430-0.860). Analyses of participants' real-time reports revealed that smokers with PTSD were more likely to attribute first-time lapses to negative affect ( = 5.412, p = .020), and trauma reminders (Fisher's exact p = .003**). Finally, the quit date decrease in DHEA(S) was related to shorter time to lapse (HR = 1.009, 95% CI: 1.000-1.018, p < .05). Results provide evidence of shorter time to first smoking lapse in PTSD, and add to evidence that early lapse occasions are more strongly related to trauma reminders, negative affect, and cravings in smokers with PTSD.

Nondestructive analysis and development

NASA Technical Reports Server (NTRS)

Moslehy, Faissal A.

1993-01-01

This final report summarizes the achievements of project #4 of the NASA/UCF Cooperative Agreement from January 1990 to December 1992. The objectives of this project are to review NASA's NDE program at Kennedy Space Center (KSC) and recommend means for enhancing the present testing capabilities through the use of improved or new technologies. During the period of the project, extensive development of a reliable nondestructive, non-contact vibration technique to determine and quantify the bond condition of the thermal protection system (TPS) tiles of the Space Shuttle Orbiter was undertaken. Experimental modal analysis (EMA) is used as a non-destructive technique for the evaluation of Space Shuttle thermal protection system (TPS) tile bond integrity. Finite element (FE) models for tile systems were developed and were used to generate their vibration characteristics (i.e. natural frequencies and mode shapes). Various TPS tile assembly configurations as well as different bond conditions were analyzed. Results of finite element analyses demonstrated a drop in natural frequencies and a change in mode shapes which correlate with both size and location of disbond. Results of experimental testing of tile panels correlated with FE results and demonstrated the feasibility of EMA as a viable technique for tile bond verification. Finally, testing performed on the Space Shuttle Columbia using a laser doppler velocimeter demonstrated the application of EMA, when combined with FE modeling, as a non-contact, non-destructive bond evaluation technique.

The development of a room temperature electron cyclotron resonance ion source (Lanzhou electron cyclotron resonance ion source No. 4) with evaporative cooling technology at Institute of Modern Physics

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

Lu, W., E-mail: luwang@impcas.ac.cn; Sun, L. T.; Qian, C.

2015-04-15

LECR4 (Lanzhou electron cyclotron resonance ion source No. 4) has been successfully constructed at IMP and has also been connected with the Low Energy Beam Transport (LEBT) and Radio Frequency Quadrupole (RFQ) systems. These source magnet coils are cooled through evaporative cooling technology, which is the first attempt with an ECR ion source in the world. The maximum mirror field is 2.5 T (with iron plug) and the effective plasma chamber volume is 1.2 l. It was designed to be operated at 18 GHz and aimed to produce intense multiple charge state heavy ion beams for the linear injector projectmore » SSC-Linac at IMP. In February 2014, the first analyzed beam at 18 GHz was extracted. During about three months’ commissioning, some outstanding results have been achieved, such as 1.97 emA of O{sup 6+}, 1.7 emA of Ar{sup 8+}, 1.07 emA of Ar{sup 9+}, and 118 euA of Bi{sup 28+}. The source has also successfully delivered O{sup 5+} and Ar{sup 8+} ion beams for RFQ commissioning in April 2014. This paper will give a brief overview of the design of LECR4. Then, the latest results of this source at 18 GHz will be presented.« less

Sharing clinical trial data on patient level: Opportunities and challenges

PubMed Central

Koenig, Franz; Slattery, Jim; Groves, Trish; Lang, Thomas; Benjamini, Yoav; Day, Simon; Bauer, Peter; Posch, Martin

2015-01-01

In recent months one of the most controversially discussed topics among regulatory agencies, the pharmaceutical industry, journal editors, and academia has been the sharing of patient-level clinical trial data. Several projects have been started such as the European Medicines Agency´s (EMA) “proactive publication of clinical trial data”, the BMJ open data campaign, or the AllTrials initiative. The executive director of the EMA, Dr. Guido Rasi, has recently announced that clinical trial data on patient level will be published from 2014 onwards (although it has since been delayed). The EMA draft policy on proactive access to clinical trial data was published at the end of June 2013 and open for public consultation until the end of September 2013. These initiatives will change the landscape of drug development and publication of medical research. They provide unprecedented opportunities for research and research synthesis, but pose new challenges for regulatory authorities, sponsors, scientific journals, and the public. Besides these general aspects, data sharing also entails intricate biostatistical questions such as problems of multiplicity. An important issue in this respect is the interpretation of multiple statistical analyses, both prospective and retrospective. Expertise in biostatistics is needed to assess the interpretation of such multiple analyses, for example, in the context of regulatory decision-making by optimizing procedural guidance and sophisticated analysis methods. PMID:24942505

Upscaling gas permeability in tight-gas sandstones

NASA Astrophysics Data System (ADS)

Ghanbarian, B.; Torres-Verdin, C.; Lake, L. W.; Marder, M. P.

2017-12-01

Klinkenberg-corrected gas permeability (k) estimation in tight-gas sandstones is essential for gas exploration and production in low-permeability porous rocks. Most models for estimating k are a function of porosity (ϕ), tortuosity (τ), pore shape factor (s) and a characteristic length scale (lc). Estimation of the latter, however, has been the subject of debate in the literature. Here we invoke two different upscaling approaches from statistical physics: (1) the EMA and (2) critical path analysis (CPA) to estimate lc from pore throat-size distribution derived from mercury intrusion capillary pressure (MICP) curve. τ is approximated from: (1) concepts of percolation theory and (2) formation resistivity factor measurements (F = τ/ϕ). We then estimate k of eighteen tight-gas sandstones from lc, τ, and ϕ by assuming two different pore shapes: cylindrical and slit-shaped. Comparison with Klinkenberg-corrected k measurements showed that τ was estimated more accurately from F measurements than from percolation theory. Generally speaking, our results implied that the EMA estimated k within a factor of two of the measurements and more precisely than CPA. We further found that the assumption of cylindrical pores yielded more accurate k estimates when τ was estimated from concepts of percolation theory than the assumption of slit-shaped pores. However, the EMA with slit-shaped pores estimated k more precisely than that with cylindrical pores when τ was estimated from F measurements.

Fifty years of the European medicines regulatory network: reflections for strengthening intra-regional cooperation in the Region of the Americas.

PubMed

Allchurch, Martin Harvey; Barbano, Dirceu Brás Aparecido; Pinheiro, Marie-Hélène; Lazdin-Helds, Janis

2016-05-01

This report considers how the experience of the European regulatory system might be applied to help strengthen the regulatory systems for medicines in the Region of the Americas. The work of the European Medicines Agencies (EMA) is carried out through its scientific committees, composed of members from European Economic Area countries. A robust legal framework allows EMA to coordinate resources from Member States' competent authorities, including, for example, assisting candidate countries as they prepare to join the European Union (EU). Capacity-building programs help countries adjust their regulatory systems ahead of full participation in the European medicines regulatory network. These programs facilitate adoption of common technical requirements, identify areas where action might be needed to ensure the smooth transposition of EU pharmaceutical law into national legislation, and prepare candidate countries for participation in EMA committees and the European regulatory network. The methodology of these programs could be of potential interest to the Pan American Health Organization (PAHO), the Regional Office of the World Health Organization for the Americas. Given resolutions adopted by the World Health Assembly and the PAHO Directing Council, there is a strong indication that the countries of the Region of the Americas wish to assemble a system that uses the existing regulatory capacity of some countries to strengthen local regulatory capacities in others.

Vigilance in the Laboratory Predicts Avoidance in the Real World: A Dimensional Analysis of Neural, Behavioral, and Ecological Momentary Data in Anxious Youth

PubMed Central

Silk, Jennifer S.; Ladouceur, Cecile D.; Ryan, Neal D.; Dahl, Ronald E.; Forbes, Erika E.; Siegle, Greg J.

2016-01-01

Vigilance and avoidance of threat are observed in anxious adults during laboratory tasks, and are posited to have real-world clinical relevance, but data are mixed in anxious youth. We propose that vigilance-avoidance patterns will become evident in anxious youth through a focus on individual differences and real-world strategic avoidance. Decreased functional connectivity between the amygdala and prefrontal cortex (PFC) could play a mechanistic role in this link. 78 clinically anxious youth completed a dot-probe task to assess vigilance to threat while undergoing fMRI. Real-world avoidance was assessed using Ecological Momentary Assessment (EMA) of self-reported suppression and distraction during negative life events. Vigilance towards threat was positively associated with EMA distraction and suppression. Functional connectivity between a right amygdala seed region and dorsomedial and right dorsolateral PFC regions was inversely related to EMA distraction. Dorsolateral PFC-amygdalar connectivity statistically mediated the relationship between attentional vigilance and real-world distraction. Findings suggest anxious youth showing attentional vigilance toward threat are more likely to use suppression and distraction to regulate negative emotions. Reduced PFC control over limbic reactivity is a possible neural substrate of this pattern. These findings lend ecological validity to laboratory vigilance assessments and suggest PFC-amygdalar connectivity is a neural mechanism bridging laboratory and naturalistic contexts. PMID:27010577

Daily Marital Interaction Quality and Carotid Artery Intima Medial Thickness in Healthy Middle Aged Adults

PubMed Central

Joseph, Nataria T.; Kamarck, Thomas W.; Muldoon, Matthew F.; Manuck, Stephen B.

2014-01-01

Objective To examine the association between marital interaction quality during daily life and subclinical cardiovascular disease (CVD). Studies have shown that marital status and quality of marriage are associated with cardiovascular health. However, little is known about the role of marital interaction quality during daily life in contributing to these effects. Methods The sample consisted of 281 healthy, employed middle-aged adults who were married or living with a partner in a marital-like relationship (mean age = 42.0 years, 88% white, 52% men). Marital interaction quality was assessed using hourly real-time Ecological Momentary Assessments (EMAs) for 4 days, with participants rating their current or recent partner interactions on positive and negative characteristics (e.g., agreeableness and conflict). Carotid artery intima medial thickness (IMT) was assessed using ultrasound imaging. Results Adjusting for demographics, positive marital interaction was inversely associated with IMT, [b = −.02 F(1, 275) = 9.18, p = .002], and negative marital interaction was positively associated with IMT, [b = .02 F(1, 275) = 10.29, p = .001]. These associations were not accounted for by behavioral and biological cardiovascular disease (CVD) risk factors and were consistent across age, sex, race, and education. The associations were also independent of marital interaction frequency, nonmarital social interaction quality, and personality factors. Global reports of marital quality, in contrast, were not associated with IMT. Conclusions Marital quality as measured during real-time interactions between partners was associated with subclinical cardiovascular disease in healthy middle-aged adults. This study supports the utility of real-time social interaction assessment for characterizing links between social relationships and cardiovascular health. PMID:24915293

44 CFR 302.4 - Merit personnel systems.

Code of Federal Regulations, 2012 CFR

2012-10-01

... HOMELAND SECURITY PREPAREDNESS CIVIL DEFENSE-STATE AND LOCAL EMERGENCY MANAGEMENT ASSISTANCE PROGRAM (EMA... maintained in public agencies administering or supervising the administration of the civil defense program in...

Preliminary neurocognitive outcomes in Jeavons syndrome.

PubMed

Fournier-Goodnight, Ashley S; Gabriel, Marsha; Perry, M Scott

2015-11-01

Jeavons syndrome (JS, eyelid myoclonia with absences [EMA]) consists of a triad of symptoms including eyelid myoclonia that may be accompanied by absence seizures, eye closure-induced EEG paroxysms or seizures, and photosensitivity. The age of onset ranges between 2 and 14 years with symptoms peaking between 6 and 8 years of age. Though investigation of the clinical, EEG, and neurological features of JS has occurred, neurocognitive functioning has not been well-delineated despite suggestion that a subtype of the syndrome is characterized in part by cognitive impairment. The purpose of this study was to define neurocognitive functioning in a more detailed manner by examining global IQ and relevant neurocognitive domains (i.e., verbal and nonverbal reasoning, attention, executive functioning, memory) in pediatric patients. The sample (N=6, 4 females) ranged in age from 8 to 15 years (M=11, SD=2.82). All participants completed neuropsychological evaluations. Statistical analyses revealed performance that was below average on measures of global IQ, processing speed and rote, verbal learning coupled with average nonverbal reasoning, and sustained attention. There was also evidence of impaired higher-level verbal reasoning. While global IQ ranged from low average to borderline impaired, no participant could be accurately described as impaired or having intellectual disability (ID) given the consistently average performance noted on some higher-order tasks including nonverbal reasoning. Copyright © 2015 Elsevier Inc. All rights reserved.

Lack of proportionality. Seven specifications of public interest that override post-approval commercial interests on limited access to clinical data.

PubMed

Strech, Daniel; Littmann, Jasper

2012-07-02

For the protection of commercial interests, licensing bodies such as the EMA and health technology assessment institutions such as NICE restrict full access to unpublished evidence. Their respective policies on data transparency, however, lack a systematic account of (1) what kinds of commercial interests remain relevant after market approval has been granted, (2) what the specific types of public interest are that may override these commercial interests post approval, and, most importantly, (3) what criteria guide the trade-off between public interest and legitimate measures for the protection of commercial interest. Comparing potential commercial interests with seven specifications of relevant public interest reveals the lack of proportionality inherent in the current practices of EMA and NICE.

Angiofibroma-like perineurioma. Report of a case.

PubMed

Zámečník, Michal; Mukenšnabl, Petr; Chlumská, Alena

2013-04-01

We report an unusual perineurioma with numerous vessels, showing a strong similarity with angiofibroma. A 2,5 x 2 x 2 cm subcutaneous/dermal tumor occurred in 58-ys-old male in the left brachial region. Histologically, it was composed of haphazardly arranged bland spindle cells and it contained prominent vasculature. In rare foci, the tumor cells showed thin bipolar processes and an onion-like perivascular whorling pattern. Immunohistochemically, expression of perineural cell markers EMA, claudin-1 and CD34 was limited to perivascular foci and to rare cells among the vessels. In addition, the tumor expressed CD10 diffusely. Our finding indicates that diagnosis of perineurioma should be considered also by tumors with an "angiofibromatous" morphology. Especially soft tissue angiofibroma, which often express EMA (perineural cell marker), shows a strong resemblance to angiofibroma-like perineurioma.

A new percolation model for composite solid electrolytes and dispersed ionic conductors

NASA Astrophysics Data System (ADS)

Risyad Hasyim, Muhammad; Lanagan, Michael T.

2018-02-01

Composite solid electrolytes (CSEs) including conductor/insulator composites known as dispersed ionic conductors (DICs) have motivated the development of novel percolation models that describe their conductivity. Despite the long history, existing models lack in one or more key areas: (1) rigorous foundation for their physical theory, (2) explanation for non-universal conductor-insulator transition, (3) classification of DICs, and (4) extension to frequency-domain. This work describes a frequency-domain effective medium approximation (EMA) of a bond percolation model for CSEs. The EMA is derived entirely from Maxwell’s equations and contains basic microstructure parameters. The model was applied successfully to several composite systems from literature. Simulations and fitting of literature data address these key areas and illustrate the interplay between space charge layer properties and bulk microstructure.

Fostering EMA's transparency policy.

PubMed

Banzi, Rita; Bertele', Vittorio; Demotes-Mainard, Jacques; Garattini, Silvio; Gluud, Christian; Kubiak, Christine; Ohmann, Christian

2014-10-01

The European Medicines Agency has opened a window to access clinical trial data. This is an important step forward which deserves attention, support, and advice from all the stakeholders. Regulatory agencies are the most comprehensive repositories of clinical trial data on drugs and can also promote and develop standard practices for data sharing. The release of the EMA draft policy on publication and access to clinical trial data in 2013 has fueled a lively debate among academia, industry, and the public in general that is still ongoing. As clinical researchers and producers and users of clinical trial data, we endorse the European Medicines Agency's opening and offer a few suggestions for complete, safe, and effective data sharing. Copyright © 2014 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.

Feasibility and adherence paradigm to ecological momentary assessments in urban minority youth.

PubMed

Shiyko, Mariya P; Perkins, Seth; Caldwell, Linda

2017-07-01

All adolescents in general, including ethnic and racial minorities, report high levels of cell phone use, making mobile technology a useful tool for assessment and intervention. Known health and education disparities based on minority status motivated us to conduct an in-depth investigation regarding feasibility of and adherence to the ecological momentary assessment (EMA) research protocol, studying daily life of urban minority youth. In addition, this paper presents a methodological approach to conceptualizing and reporting adherence in EMA studies. The sample was comprised of 126 youth (41.3% boys; 40.5% 7th and 59.5% 8th graders; 75.4% African American, and 20.6% Hispanic) who carried a mobile phone for 10 days, including 2 weekends and reported on activities, moods, and attitudes. Mean level of adherence was 81% for momentary and 93.8% for daily assessments; it decreased over time and was higher during the week compared to weekends. Adherence was lower on days when participants reported high levels of negative affect and on days when they were engaged in physical activities. Our findings underscore the importance of differentiating between human and technology-related factors when computing adherence rates and portray adherence as a complex and dynamic construct that can vary across individuals. Specific study recommendations and methodological discussion provide guidelines for designing future studies. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Temporal Associations Between Social Activity and Mood, Fatigue, and Pain in Older Adults With HIV: An Ecological Momentary Assessment Study.

PubMed

Paolillo, Emily W; Tang, Bin; Depp, Colin A; Rooney, Alexandra S; Vaida, Florin; Kaufmann, Christopher N; Mausbach, Brent T; Moore, David J; Moore, Raeanne C

2018-05-14

Social isolation is associated with an increased risk for mental and physical health problems, especially among older persons living with HIV (PLWH). Thus, there is a need to better understand real-time temporal associations between social activity and mood- and health-related factors in this population to inform possible future interventions. This study aims to examine real-time relationships between social activity and mood, fatigue, and pain in a sample of older PLWH. A total of 20 older PLWH, recruited from the University of California, San Diego HIV Neurobehavioral Research Program in 2016, completed smartphone-based ecological momentary assessment (EMA) surveys 5 times per day for 1 week. Participants reported their current social activity (alone vs not alone and number of social interactions) and levels of mood (sadness, happiness, and stress), fatigue, and pain. Mixed-effects regression models were used to analyze concurrent and lagged associations among social activity, mood, fatigue, and pain. Participants (mean age 58.8, SD 4.3 years) reported being alone 63% of the time, on average, (SD 31.5%) during waking hours. Being alone was related to lower concurrent happiness (beta=-.300; 95% CI -.525 to -.079; P=.008). In lagged analyses, social activity predicted higher levels of fatigue later in the day (beta=-1.089; 95% CI -1.780 to -0.396; P=.002), and higher pain levels predicted being alone in the morning with a reduced likelihood of being alone as the day progressed (odds ratio 0.945, 95% CI 0.901-0.992; P=.02). The use of EMA elucidated a high rate of time spent alone among older PLWH. Promoting social activity despite the presence of pain or fatigue may improve happiness and psychological well-being in this population. ©Emily W Paolillo, Bin Tang, Colin A Depp, Alexandra S Rooney, Florin Vaida, Christopher N Kaufmann, Brent T Mausbach, David J Moore, Raeanne C Moore. Originally published in JMIR Mental Health (http://mental.jmir.org), 14.05.2018.

Reported time to onset of neurological adverse drug reactions among different age and gender groups using metoclopramide: an analysis of the global database Vigibase®.

PubMed

Svendsen, Kristian; Wood, Mollie; Olsson, Erika; Nordeng, Hedvig

2018-05-01

Despite FDA and EMA warnings of long-term use, little is known regarding the time to onset (TTO) of neurological adverse drug reactions (ADR) for metoclopramide. The aims of this study were, first, to evaluate whether neurological ADRs are more commonly reported for metoclopramide than for other medications, and second, to describe how time to onset of neurological ADRs differs by age and gender. All ADR reports with metoclopramide as the suspected/interacting drug were extracted from the WHOs Global ADR database Vigibase® between 1967 and May 2016. Cox proportional hazards models were fit using TTO of neurological ADRs as the outcome and age, gender, and type of ADR as predictors. Proportional Reporting Ratios (PRRs) for neurological ADRs were compared across age and gender. Lawyer reports were excluded in the analysis. Over 47,000 ADR reports with metoclopramide were identified. Over one third (35.6%) of the reports came from lawyers. The majority of ADRs in general and neurological ADRs in specific occurred within the first 5 days of metoclopramide use (median 1 day). TTO increased with age. Neurological ADRs were reported two to four times as frequently for metoclopramide than for other drugs, with the highest PRRs observed in children (PRR = 4.24 for girls and 4.60 for boys). Most adverse drug reactions occur within the first 5 days of treatment with metoclopramide. Patients requiring use of metoclopramide should be carefully monitored for neurological ADRs during the first days of treatment.

Screening of coeliac disease in undetected adults and patients diagnosed with irritable bowel syndrome in Riyadh, Saudi Arabia.

PubMed

Al-Ajlan, Abdulrahman S

2016-07-01

The present study is to determine the prevalence and implication of coeliac disease (CD) among adult Saudis and compared to those with diagnosed irritable bowel syndrome. This prospective study was conducted among 980 adults. Out of that, 482 subjects (staff and students of Riyadh Health Science College) were designated as control cohorts for undetected coeliac disease. Furthermore, another contingent of 498 subjects diagnosed with irritable bowel syndrome (IBS) at Prince Salman Hospital and Al-Iman General Hospital also constituted a segment of the overall initial 1020 subjects. Both cases and control were tested for serological markers of coeliac disease (tissues transglutaminase (tTGAs) and endomysial autoantibody (EMAs) and were confirmed by histopathology test. All the positive for cases of coeliac disease were screened for iron deficiency anaemia, Vitamin D deficiency, and osteoporosis and weight assessment. The percentage of coeliac disease in control subjects and patients diagnosed with irritable bowel syndrome (IBS) were found to be 1.9% and 9.6% respectively, about 38% of the total coeliac disease patients are among females of middle age (20-39-years) and 16% of the males in the same age range. Whereas, 20% and 25% of all coeliac disease cases with ages of 40-59 were remarked as females and males respectively. The identical nature and overlap of symptoms of the two conditions could possibly result in misdiagnosis of coeliac diseases or over-diagnosis of irritable bowel syndrome. The findings of the study might also give considerable implications of the disease in the nutritional level which is noticeable.

Concept of biosimilar products in Jordan.

PubMed

Haddadin, Rania Dakhlallah

2011-09-01

After the expiration of patents on originator biological products, Jordanian local manufacturers and the agents of international pharmaceutical companies in Jordan started to submit registration dossiers for biosimilar products. The Jordan Food and Drug Administration (JFDA) is the national regulatory authority responsible for the registration of biosimilar products. Biosimilars are registered under the same regulations used for drugs until specific guidelines for registration of biological and biosimilar products are released. Those regulations are called Criteria of Registration of Drugs, Vaccines, Sera and Biological Products, the Renewal of its Registration and the Cancellation of Any of them which was published in the official gazette in 2004 under the Provisional Law Number 80 of the year 2001, Drug and Pharmacy Law and its amendments of the year 2003. Also, the JFDA follows the EMA guidelines on similar biological medicinal products for specific active biological substances for non-clinical and clinical studies requirements and the EMA guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues. A post marketing surveillance study is requested after a biosimilar product is authorized. The JFDA keeps pace with all advances in the regulatory issues related to biosimilars in order to be capable of authorizing biosimilar products with a safe, effective and good quality profile. Copyright © 2011. Published by Elsevier Ltd.

Individual and combined effects of multiple high-risk triggers on postcessation smoking urge and lapse.

PubMed

Lam, Cho Y; Businelle, Michael S; Aigner, Carrie J; McClure, Jennifer B; Cofta-Woerpel, Ludmila; Cinciripini, Paul M; Wetter, David W

2014-05-01

Negative affect, alcohol consumption, and presence of others smoking have consistently been implicated as risk factors for smoking lapse and relapse. What is not known, however, is how these factors work together to affect smoking outcomes. This paper uses ecological momentary assessment (EMA) collected during the first 7 days of a smoking cessation attempt to test the individual and combined effects of high-risk triggers on smoking urge and lapse. Participants were 300 female smokers who enrolled in a study that tested an individually tailored smoking cessation treatment. Participants completed EMA, which recorded negative affect, alcohol consumption, presence of others smoking, smoking urge, and smoking lapse, for 7 days starting on their quit date. Alcohol consumption, presence of others smoking, and negative affect were, independently and in combination, associated with increase in smoking urge and lapse. The results also found that the relationship between presence of others smoking and lapse and the relationship between negative affect and lapse were moderated by smoking urge. The current study found significant individual effects of alcohol consumption, presence of other smoking, and negative affect on smoking urge and lapse. Combing the triggers increased smoking urge and the risk for lapse to varying degrees, and the presence of all 3 triggers resulted in the highest urge and lapse risk.

Juvenile animal studies and pediatric drug development: a European regulatory perspective.

PubMed

Carleer, Jacqueline; Karres, Janina

2011-08-01

During the workshop organized by ILSI/HESI on May 5-6, 2010 on the value of juvenile animal toxicity studies, the implementation of the European Pediatric Regulation and in particular the review process of the nonclinical part of the Pediatric Investigation Plan (PIP) were described. A PIP is intended to outline the development of a medicinal product in the pediatric population (i.e. quality, safety, efficacy of the medicine and timing of studies); it is reviewed and agreed by the Pediatric Committee (PDCO) of the European Medicines Agency (EMA).  The Nonclinical Working Group (NcWG) supports the PDCO in the review process of the nonclinical part of a PIP and is composed of members from the PDCO, the EMA Safety Working Party, additional experts from national competent authorities and the FDA.  This article summarizes the NcWG review process and outcomes of 97 approved or ongoing PIPs, from the establishment of the NcWG in November 2008 to May 2010, as presented during the workshop. Juvenile animal studies were proposed by the applicant in 33% or required by the NcWG in 26% of the PIPs. The requirements were mainly motivated by concerns regarding potential developmental toxicities, in view of the young age of the pediatric population to be investigated, the lack of knowledge concerning the maturation of the pharmacological target, the lack of sufficient (non)clinical data, observed toxicities in the adult (non)clinical studies and the long duration of the intended treatments. Most juvenile animal studies were in the therapeutic areas of oncology, infectious diseases and endocrinology. In about 14% of the PIPs submitted, the NcWG requested either justifications of, or amendments to the study designs proposed by the applicants (e.g. justification of endpoints, study duration, species selection and timing with regards to clinical pediatric studies). Generally, only one species was selected or proposed for the juvenile studies, the rat being the most prevalent. The number of juvenile studies initially proposed by the applicant plus those requested by the NcWG was higher than the number of studies included in the "key binding elements" of the PIP opinions. This apparent discrepancy was mainly due to additional information or justifications submitted by the applicant during the clock stop. It was noted that the PIPs initially submitted often lacked information relevant to the nonclinical evaluation. Therefore, during the workshop, the need to provide scientifically based justifications when no juvenile animal studies are proposed in the initial PIP submission was stressed. © 2011 Wiley-Liss, Inc.

Co-rumination and co-problem solving in the daily lives of adolescents with major depressive disorder.

PubMed

Waller, Jennifer M; Silk, Jennifer S; Stone, Lindsey B; Dahl, Ronald E

2014-08-01

This study examines differences in the prevalence and nature of co-rumination during real-world social interactions with peers and parents among adolescents with major depressive disorder (MDD) compared to healthy controls. A total of 60 youth (29 with current MDD and 31 controls without psychopathology) completed a self-report measure of co-rumination and a 3-week ecological momentary assessment (EMA) protocol that measured the nature of face-to-face social interactions with peers and parents after a negative event in the adolescents' daily lives. Specifically, EMA was used to assess rates of problem talk, including both co-rumination and co-problem solving. Group differences in self-report and EMA measures were examined. Adolescents with MDD reported co-ruminating more often than adolescents with no Axis 1 disorders during daily interactions with both parents (Cohen's d = 0.78) and peers (d = 1.14), and also reported more co-rumination via questionnaire (d = 0.58). Adolescents with MDD engaged in co-problem solving with peers less often than did healthy controls (d = 0.78), but no group differences were found for rates of co-problem solving with parents. Results are consistent with previous research linking co-rumination and depression in adolescence and extend these self-report-based findings to assessment in an ecologically valid context. Importantly, the results support that MDD youth tend to co-ruminate more and to problem-solve less with peers in their daily lives compared to healthy youth, and that co-rumination also extends to parental relationships. Interventions focused on decreasing co-rumination with peers and parents and improving problem-solving skills with peers may be helpful for preventing and treating adolescent depression. Copyright © 2014 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.

Joint position statement by “Sociedad Española de Patología Digestiva” (Spanish Society of Gastroenterology) and “Sociedad Española de Farmacología” (Spanish Society of Pharmacology) on biosimilar therapy for inflammatory bowel disease.

PubMed

Argüelles-Arias, Federico; Barreiro-de-Acosta, Manuel; Carballo, Fernando; Hinojosa, Joaquín; Tejerina, Teresa

2013-01-01

Biological drugs or biopharmaceutical products, manufactured with or from living organisms using biotechnology, have represented a therapeutic revolution for the control of inflammatory bowel disease (IBD). At present, in this indication and in our country, only two biological are approved, infliximab (IFX) and adalimumab (ADA), both of them monoclonal antibodies against tumor necrosis factor alpha. Effectiveness data are strong for both therapies, with maximum levels of scientific evidence.The upcoming expiry date for these biologicals´ patents has allowed the potential marketing of so-called biosimilar agents for the IBD indication. While biosimilars are conceptually for biological what generics are for chemical drugs, the structural complexity of biosimilars and their biological and manufacturing variability lead to consider validation processes for these two types in humans as highly differential. Thus, in our setting, under the coverage of "Agencia Española del Medicamento y Productos Sanitarios (AEMPS)" (Spanish Agency of Medicines and Medical Devices), guidelines issued by the European Medicines Agency (EMA) are to be applied, which states that a number of stages or steps must be overcome in order to obtain approval for a biosimilar agent.However, despite the presence of these recommendations by EMA, which must be met by a biosimilar in order to be licensed in our marketplace, relevant uncertainties persist that only future decisions by EMA and AEMPS may clarify. The present stance by our task force is that biosimilar development should be undertaken according to established regulations, thus certifying their efficacy and safety. Similarly, this task force considers that results obtained from studies in rheumatoid arthritis (RA) should not be extrapolated to IBD since the biological variability of these complex structures will not ensure a lack of noticeable changes in efficacy and safety.

Mycolactone-mediated neurite degeneration and functional effects in cultured human and rat DRG neurons

PubMed Central

Sinisi, M; Fox, M; MacQuillan, A; Quick, T; Korchev, Y; Bountra, C; McCarthy, T; Anand, P

2016-01-01

Background Mycolactone is a polyketide toxin secreted by the mycobacterium Mycobacterium ulcerans, responsible for the extensive hypoalgesic skin lesions characteristic of patients with Buruli ulcer. A recent pre-clinical study proposed that mycolactone may produce analgesia via activation of the angiotensin II type 2 receptor (AT2R). In contrast, AT2R antagonist EMA401 has shown analgesic efficacy in animal models and clinical trials for neuropathic pain. We therefore investigated the morphological and functional effects of mycolactone in cultured human and rat dorsal root ganglia (DRG) neurons and the role of AT2R using EMA401. Primary sensory neurons were prepared from avulsed cervical human DRG and rat DRG; 24 h after plating, neurons were incubated for 24 to 96 h with synthetic mycolactone A/B, followed by immunostaining with antibodies to PGP9.5, Gap43, β tubulin, or Mitotracker dye staining. Acute functional effects were examined by measuring capsaicin responses with calcium imaging in DRG neuronal cultures treated with mycolactone. Results Morphological effects: Mycolactone-treated cultures showed dramatically reduced numbers of surviving neurons and non-neuronal cells, reduced Gap43 and β tubulin expression, degenerating neurites and reduced cell body diameter, compared with controls. Dose-related reduction of neurite length was observed in mycolactone-treated cultures. Mitochondria were distributed throughout the length of neurites and soma of control neurons, but clustered in the neurites and soma of mycolactone-treated neurons. Functional effects: Mycolactone-treated human and rat DRG neurons showed dose-related inhibition of capsaicin responses, which were reversed by calcineurin inhibitor cyclosporine and phosphodiesterase inhibitor 3-isobutyl-1-Methylxanthine, indicating involvement of cAMP/ATP reduction. The morphological and functional effects of mycolactone were not altered by Angiotensin II or AT2R antagonist EMA401. Conclusion Mycolactone induces toxic effects in DRG neurons, leading to impaired nociceptor function, neurite degeneration, and cell death, resembling the cutaneous hypoalgesia and nerve damage in individuals with M. Ulcerans infection. PMID:27325560

Characterization of Theileria equi genotypes in horses in Israel, the Palestinian Authority and Jordan.

PubMed

Ketter-Ratzon, Dafna; Tirosh-Levy, Sharon; Nachum-Biala, Yaarit; Saar, Tal; Qura'n, Lara; Zivotofsky, Doni; Abdeen, Ziad; Baneth, Gad; Steinman, Amir

2017-06-01

Equine theileriosis caused by Theileria equi is endemic in the Middle East, where it causes a severe disease as well as widespread subclinical infection. The aim of this study was to evaluate the diversity of T. equi genotypes in Israel and the neighboring Palestinian Authority and Jordan. Blood samples from 355 horses from Israel, the Palestinian Authority and Jordan were tested for the prevalence of T. equi DNA. Two hundred and fourteen (60%) were found positive for T. equi infection by PCR. Of those, the 18S rRNA (1458bp) and the EMA-1 (745bp) genes of T. equi were sequenced from 15 horse samples that represent Israel's geographical distribution together with four samples from the Palestinian Authority and two from Jordan. The results were used for genotype characterization and phylogenetic analysis of T. equi in the equine population in Israel and its surroundings. Three 18S rRNA genotype clades were found in Israel (A, C and D) with clade D being the most prevalent and included all four isolates from the PA. In contrast, the EMA-1 gene showed little diversity with all sequences clustering in the same clade apart from one Jordanian sequence. Results suggest that although the Israeli horse population is small and relatively confined geographically, it is probable that the genetic variability, which was found among Israeli horses, is a result of introduction of horses from other countries. It also suggests that the EMA-1 gene is probably not a good target for the evaluation of variance in T. equi populations. Characterization of the different genotypes prevalent in a certain region is important in order to map out the intra-species sequence heterogeneity of the parasite, which is needed in order to develop new diagnostic tools and vaccines. Copyright © 2017 Elsevier GmbH. All rights reserved.

MID-ATLANTIC REGIONAL VULNERABILITY ASSESSMENT

EPA Science Inventory

ORD's Regional Vulnerability Assessment (REVA) Program is developing and demonstrating approaches to assess current and future environmental vulnerabilities so that risk management activities can be targeted. The sister program to EMA.P (Environmental Monitoring Assessment Progr...

Early life family conflict, Social interactions and Carotid Artery Intima-Media Thickness in Adulthood

PubMed Central

John-Henderson, Neha A.; Kamarck, Thomas W.; Muldoon, Matthew F.; Manuck, Stephen B.

2015-01-01

Objective Conflict in early life family environments is known to affect psychosocial functioning and coping styles into adulthood and is reported to negatively affect access to psychosocial resources that are critical to the management of stress. However, it remains unknown whether early life family conflict similarly affects subclinical cardiovascular disease (CVD) in adulthood. We predicted that family conflict in early life would be associated with greater mean Intima-Media thickness (IMT), a subclinical marker of CVD risk, in adulthood. Methods Data were collected in a community sample of 503 adults (47.4 % male, mean age: 42.8 years [SD=7.3]). Associations between family conflict in early life with IMT (assessed using B-mode ultrasound) in adulthood were examined using regression analysis. We also tested for indirect effects of early life family conflict on mean IMT through ecological momentary assessment (EMA) reports of social interactions, diversity of social roles, and perceived social support. Results Linear regression analyses adjusted for demographics and physiological risk factors showed conflict in early life associated with greater mean IMT (β=0.08, t(447)=2.13, p=0.034, R2=0.46). Early life conflict was significantly related to diversity of social roles, perceived social support, and EMA reports of pleasant and social conflict interactions. Significant indirect effects of early life conflict on mean IMT were observed through fewer pleasant social interactions and more frequent social conflict interactions in adulthood (β = 0.001, 95% CI, 0.0001–0.0014 and β=0.001, 95% CI, 0.0002–0.0015, respectively). Conclusions These findings provide initial evidence that family conflict in early life heightens CVD risk in adulthood, in part by shaping the quality of adulthood social interactions. PMID:26809109

An electromechanical actuation system for an expendable launch vehicle

NASA Technical Reports Server (NTRS)

Burrows, Linda M.; Roth, Mary E.

1992-01-01

A major effort at NASA-Lewis in recent years has been to develop electro-mechanical actuators (EMA's) to replace the hydraulic systems used for thrust vector control (TVC) on launch vehicles. This is an attempt to overcome the inherent inefficiencies and costs associated with the existing hydraulic structures. General Dynamics Space Systems Division, under contract to NASA Lewis, is developing 18.6 kW (25 hp), 29.8 kW (40 hp), and 52.2 kW (70 hp) peak EMA systems to meet the power demands for TVC on a family of vehicles developed for the National Launch System. These systems utilize a pulse population modulated converter and field-oriented control scheme to obtain independent control of both the voltage and frequency. These techniques allow an induction motor to be operated at its maximum torque at all times.

Closed loop performance of a brushless dc motor powered electromechanical actuator for flight control applications. [computerized simulation for Shuttle Orbiter applications

NASA Technical Reports Server (NTRS)

Demerdash, N. A.; Nehl, T. W.

1980-01-01

A comprehensive digital model for the analysis and possible optimization of the closed loop dynamic (instantaneous) performance of a power conditioner fed, brushless dc motor powered, electromechanical actuator system (EMA) is presented. This model was developed for the simulation of the dynamic performance of an actual prototype EMA built for NASA-JSC as a possible alternative to hydraulic actuators for consideration in Space Shuttle Orbiter applications. Excellent correlation was achieved between numerical model simulation and experimental test results obtained from the actual hardware. These results include: various current and voltage waveforms in the machine-power conditioner (MPC) unit, flap position as well as other control loop variables in response to step commands of change of flap position. These results with consequent conclusions are detailed in the paper.

A disease looking for innovative drugs: The case of pulmonary arterial hypertension.

PubMed

Joppi, Roberta; Gerardi, Chiara; Bertele', Vittorio; Garattini, Silvio

2018-05-25

Pulmonary arterial hypertension (PAH) is a life-threatening rare disease. Between 2001 and 2016 the European Medicines Agency (EMA) approved nine drugs to treat PAH. Considering the poor prognosis of patients with PAH it would be useful to understand whether the approved therapies can change the natural history of the disease. We assessed the therapeutic value and the quality of the evidence on medicines that have been authorized by the EMA in the 2000s. Information about drug approval was obtained from the EMA website and the European Public Assessment Reports. MedLine, Embase, and Cochrane databases were systematically searched for published randomized clinical trials and meta-analyses of the selected drugs and their combinations. At the time of approval no medicine had been proved to reduce mortality or slow the progression of the disease or to improve patients' quality of life. Recent meta-analyses concluded that, compared to placebo, active treatments reduced mortality but there was no conclusion on any preferred therapeutic option. Approvals of monotherapies in the absence of best evidence of their efficacy, have prompted the search for better efficacy of their combinations. Three meta-analyses found no advantage in survival from combinations as opposed to monotherapies. This model case confirms previous analyses that marketing authorizations granted in spite of low evidence of therapeutic efficacy not only expose patients to treatments with unknown benefit-risk profiles but also hamper post-marketing research aimed at filling the information gap. Copyright © 2018. Published by Elsevier B.V.

Drug safety and the impact of drug warnings: An interrupted time series analysis of diabetes drug prescriptions in Germany and Denmark.

PubMed

Hostenkamp, Gisela; Fischer, Katharina Elisabeth; Borch-Johnsen, Knut

2016-12-01

To analyse the impact of drug safety warnings from the European Medicines Agency (EMA) on drug utilisation and their interaction with information released through national reimbursement bodies. Insurance claims data on anti-diabetic drug prescriptions in primary care in Germany and Denmark were analysed using interrupted time series analysis, with EMA drug warnings for thiazolidinediones (TZDs) in 2007 and 2011 as the intervention. Monthly drug utilisation data per substance in defined daily dosages (DDD) consumed per 1000 insurees were retrieved from the Danish national drug prescriptions register and one large statutory sickness fund in Germany. TZDs were generally reimbursed in Germany but restricted to individual reimbursement in Denmark. Consequently, utilisation of TZDs was much higher in Germany in 2007 compared with Denmark. For rosiglitazone, the drug warning had a significant impact on utilisation, reducing the number of DDD per 1000 insurees per day by -0.0105 in Denmark and -0.0312 in Germany (p-values<0.05). For pioglitazone, neither of the drug warnings had a significant effect on utilisation. The impact of EMA drug warnings differed across countries and might be mediated by information released through national reimbursement bodies and physician associations. Increasing complexity of new drugs and modified approval procedures require a strengthening of information exchange between drug regulation bodies and physicians to ensure patient safety. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

First year of AIDS services delivery under Title I of the Ryan White CARE Act.

PubMed Central

Bowen, G S; Marconi, K; Kohn, S; Bailey, D M; Goosby, E P; Shorter, S; Niemcryk, S

1992-01-01

This is a review of (a) the emergency assistance for ambulatory HIV medical and support services provided in the first year by eligible metropolitan areas (EMAs) funded under Title I of the Ryan White Comprehensive AIDS Resources Emergency (CARE) Act of 1990, (b) the varied responses and processes by which the 16 urban areas receiving Title I funds in 1991 met legislative mandates, (c) the central nature of planning councils under Title I and their formation and functioning, and (d) issues related to current implementation and future expansion of Title I to additional eligible metropolitan areas. Integral to the review is a brief discussion of the history of AIDS and HIV infection, particularly in cities receiving CARE Act funding, an overview of Title I requirements, and a description of the organizational structures cities are using to implement Title I. Information on Title I EMAs is based on analysis of their 1991 applications, bylaws of their HIV service planning councils, intergovernmental agreements between Title I cities and other political entities, and contracts executed by Title I grantees with providers for the delivery of services. Interviews with personnel in several Title I EMAs, including planning council members and grantee staff members, provided additional information. This is the first descriptive accounting of activities related to the 1991 applications for and uses of Title I funds, and the administrative and service issues related to this process. PMID:1410229

What to Know About Medicines With New Active Ingredients Approved in FY 2016 / 2016 in Japan and EU: A Brief Comparison of New Medicines Approved in Japan and the EU in 2016.

PubMed

Kondo, Hideyuki; Saint-Raymond, Agnès; Yasuda, Naoyuki

2018-03-01

The Pharmaceuticals and Medical Devices Agency (PMDA) in Japan and the European Medicines Agency (EMA) have a long-standing experience of reviews of new medicines, and they meet their target pre-market review periods. In FY 2016 / 2016, 112 and 83 new medicines were approved in Japan and EU, respectively. Out of these medicines, 41 and 27 medicines containing new active ingredients were approved with total pre-market review periods of 209 days and 428 days in Japan and EU, respectively. Approximately one-third of these medicines were reviewed by the Agencies in close timing, within 1 year between pre-market review applications in Japan and in EU. Taking into account the increasing number of global clinical trials and constant number of consultations or scientific advice related to global clinical trials in Japan, it is clear that the importance of the continuous, collaborative relationship between EMA and PMDA is more and more crucial, as it does facilitate close and timely exchange of information and opinions on products and technologies under development. There already are effective collaborative frameworks between PMDA and EMA in addition to daily communication, and our findings support the development and best use of regulatory tools such as consultation services and scientific advice/protocol assistance for the benefit of the pharmaceutical industry but mostly of patients.

Emotion dysregulation and negative affect: Laboratory and EMA investigations in smokers.

PubMed

MacIntyre, Jessica M; Ruscio, Aimee C; Brede, Emily; Waters, Andrew J

2018-06-01

Difficulties in emotion regulation are associated with addictive behaviors, including smoking. Difficulties in emotion regulation may underlie large, rapid changes in negative affect that can increase likelihood of relapse. We investigated the association between emotion regulation ability and negative affect in smokers assessed both in the laboratory and in the field using Ecological Momentary Assessment. Adult community smokers ( N  = 44) carried a personal digital assistant (PDA) for two weeks and were instructed to complete assessments of negative affect multiple times per day. Participants were instructed that they could smoke as much or as little as they liked. The Difficulties in Emotion Regulation Scale (DERS) and the Positive and Negative Affect Schedule (PANAS) were completed at three lab visits. Participants with higher average DERS scores reported greater negative affect at lab visits. When a participant reported a DERS score at a lab visit higher than their individual average, they also reported higher negative affect at that lab visit. Participants with higher baseline DERS scores reported more labile negative affect during EMA than those with lower baseline DERS scores, and they also reported a higher maximum level of negative affect during EMA. Overall, the findings suggest that changes in emotion regulation are associated with negative affect and that emotion regulation ability is related to both the intensity and lability of negative affect. A better understanding of momentary changes in emotion regulation and negative affect may lead to improved interventions for preventing substance use relapse.

Vigilance in the laboratory predicts avoidance in the real world: A dimensional analysis of neural, behavioral, and ecological momentary data in anxious youth.

PubMed

Price, Rebecca B; Allen, Kristy Benoit; Silk, Jennifer S; Ladouceur, Cecile D; Ryan, Neal D; Dahl, Ronald E; Forbes, Erika E; Siegle, Greg J

2016-06-01

Vigilance and avoidance of threat are observed in anxious adults during laboratory tasks, and are posited to have real-world clinical relevance, but data are mixed in anxious youth. We propose that vigilance-avoidance patterns will become evident in anxious youth through a focus on individual differences and real-world strategic avoidance. Decreased functional connectivity between the amygdala and prefrontal cortex (PFC) could play a mechanistic role in this link. 78 clinically anxious youth completed a dot-probe task to assess vigilance to threat while undergoing fMRI. Real-world avoidance was assessed using Ecological Momentary Assessment (EMA) of self-reported suppression and distraction during negative life events. Vigilance toward threat was positively associated with EMA distraction and suppression. Functional connectivity between a right amygdala seed region and dorsomedial and right dorsolateral PFC regions was inversely related to EMA distraction. Dorsolateral PFC-amygdalar connectivity statistically mediated the relationship between attentional vigilance and real-world distraction. Findings suggest anxious youth showing attentional vigilance toward threat are more likely to use suppression and distraction to regulate negative emotions. Reduced PFC control over limbic reactivity is a possible neural substrate of this pattern. These findings lend ecological validity to laboratory vigilance assessments and suggest PFC-amygdalar connectivity is a neural mechanism bridging laboratory and naturalistic contexts. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

Analytical challenges and regulatory requirements for nasal drug products in europe and the u.s.

PubMed

Trows, Sabrina; Wuchner, Klaus; Spycher, Rene; Steckel, Hartwig

2014-04-11

Nasal drug delivery can be assessed by a variety of means and regulatory agencies, e.g., the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have published a set of guidelines and regulations proposing in vitro test methods for the characterization of nasal drug products. This article gives a summary of the FDA and EMA requirements regarding the determination of droplet size distribution (DSD), plume geometry, spray pattern and shot weights of solution nasal sprays and discusses the analytical challenges that can occur when performing these measurements. In order to support findings from the literature, studies were performed using a standard nasal spray pump and aqueous model formulations. The aim was to identify possible method-, device- and formulation-dependent influencing factors. The literature review, as well as the results from the studies show that DSD, plume geometry and spray pattern are influenced by, e.g., the viscosity of the solution, the design of the device and the actuation parameters, particularly the stroke length, actuation velocity and actuation force. The dominant factor influencing shot weights, however, is the adjustment of the actuation parameters, especially stroke length and actuation velocity. Consequently, for routine measurements assuring, e.g., the quality of a solution nasal spray or, for in vitro bioequivalence studies, the critical parameters, have to be identified and considered in method development in order to obtain reproducible and reliable results.

Seroprevalence of coeliac disease in at-risk subjects at the main tertiary hospital, southwest of Saudi Arabia.

PubMed

Al-Hakami, Ahmed M

2016-03-01

Coeliac disease (CD) is a gluten-induced autoimmune inflammation of small bowel villi, leading to atrophy and malabsorption. The current study aims to assess the prevalence of CD in high-risk subjects in the Aseer region, southwest of Saudi Arabia and to investigate the associated presentations. This is a retrospective case-finding study of the laboratory records for a 3-year period (2009-2012) at the main tertiary hospital (Aseer Central Hospital). Serum anti-tissue transglutaminase (atTG) and endomysial antibody (EmA) levels were determined along with small intestinal histopathological examination. The proportion of cases that tested positive for at least one coeliac antibody marker was 18.4% (58/315). Forty cases underwent endoscopic examination during the analysis, among which 22 were confirmed to have CD. The individual antibody positivity for atTG and EmA was 17.5% and 15.6%, respectively. The most common clinical condition (47%) associated with these markers was type 1 diabetes mellitus (T1DM). Interestingly, gastrointestinal presentations constituted only 11.5%. The rate of CD among hospital requests, including non-gastrointestinal symptomatic patients, at the Aseer main tertiary hospital seems to be high. Determining the prevalence of CD and also investigating the high-risk group commonly affected by CD warrant more screening studies. Copyright © 2016 Arab Journal of Gastroenterology. Published by Elsevier B.V. All rights reserved.

Development of a distance-to-roadway proximity metric to compare near-road pollutant levels to a central site monitor

NASA Astrophysics Data System (ADS)

Barzyk, Timothy M.; George, Barbara Jane; Vette, Alan F.; Williams, Ronald W.; Croghan, Carry W.; Stevens, Carvin D.

The primary objective of the Detroit Exposure and Aerosol Research Study (DEARS) was to compare air pollutant concentrations measured at various neighborhoods, or exposure monitoring areas (EMAs), throughout a major metropolitan area to levels measured at a central site or community monitor. One of the EMAs was located near a busy freeway (annual average daily traffic (AADT) of ˜130,000) so that impacts of mobile sources could be examined. Air pollution concentrations from the roadway-proximate sites were compared to the central site monitor. The volatile organic compounds (VOCs) selected (benzene, toluene, ethylbenzene, m,p- and o-xylene, 1,3 butadiene, 1,3,5-trimethylbenzene and 4-ethyltoluene) are typically associated with mobile sources. Gradients were also evident that demonstrated the amplification of pollutant levels near the roadway compared to the community monitor. A novel distance-to-roadway proximity metric was developed to plot the measurements and model these gradients. Effective distance represents the actual distance an air parcel travels from the middle of a roadway to a site and varies as a function of wind direction, whereas perpendicular distance is a fixed distance oriented normal to the roadway. Perpendicular distance is often used as a proxy for exposures to traffic emissions in epidemiological studies. Elevated concentrations of all the compounds were found for both a summer and winter season. Effective distance was found to be a statistically significant ( p < 0.05) univariate predictor for concentrations of toluene, ethylbenzene, m,p-xylene and o-xylene for summer 2005. For each of these pollutants, effective distance yielded lower p-values than the corresponding perpendicular distance models, and model fit improved. Results demonstrate that this near-road EMA had elevated levels of traffic-related VOCs compared to the community monitor, and that effective distance was a more accurate predictor of the degree to which they were elevated as a function of distance. Effective distance produced a range of distance-to-roadway values for a single site based on wind direction, thus increasing the number and range of values that could be used to plot and predict relative differences in pollutant concentrations between two sites.

A New Ethical Challenge for Institutional Review Boards (IRBs)/Ethics Committees (ECs) in the Assessment of Pediatric Clinical Trials

PubMed Central

Rose, Klaus; Kummer, Hans

2015-01-01

Both the US and EU have introduced pediatric pharmaceutical legislation to facilitate clinical trials in children and development of better medicines for children. The first concerns were published in 2014 that the European Medicines Agency (EMA)’s Pediatric Committee (PDCO) may be over-enthusiastic and has compelled questionable pediatric clinical trials from pharmaceutical companies. Numerous clinical trials are mandated in rare conditions for which not enough patients exist for even one trial. Furthermore, where these trials are mandated in adolescent patients, the legal age limit of the 18th birthday is confused with a medical age limit and can result in separate clinical trials in adolescent patients that neither make medical nor scientific sense nor will ever recruit enough patients for a meaningful outcome. To confirm our concerns we searched the registry clinicaltrials.gov and found examples for PDCO-triggered unethical trials. We conclude that such trials should not be accepted by institutional review boards (IRBs)/ethics committees (ECs) and that clinical trials resulting from negotiations with EMA’s PDCO need extra careful scrutiny by IRBs/ECs in order to prevent unethical studies and damage to pediatric research and unnecessary risks to pediatric patients. PMID:27417359

Electronic Diaries: Appraisal and Current Status

PubMed Central

Broderick, Joan E.

2009-01-01

The recent explosion of technology has moved the field of patient reported outcomes (PROs) into a new era. Use of paper-and-pencil questionnaires administered before and after treatment has been eclipsed by highly sophisticated random prompts for symptom ratings at multiple points throughout the day, a method known as ecological momentary assessment (EMA). During the last 25 years, research has demonstrated that retrospective ratings are subject to a variety of cognitive heuristics that can distort the report. Initially, this was addressed by adopting paper diary protocols involving multiple ratings in a day or across a week. Technology was also advancing, and some researchers began to utilize electronic platforms for EMA assessment. A good deal of research has been conducted comparing paper and electronic formats. Issues of compliance have been particularly problematic for paper diaries. Electronic technologies can be expensive and require expertise in programming and data management. Not all research questions will require intensive momentary assessment, and end-of-day ratings may be adequate for many applications. What is required of the investigator is familiarity with the strengths and weaknesses of the methods and platforms available as well as a reasoned decision to elect a particular methodology for the study question at hand. PMID:20037672

Dynamic analysis of I cross beam section dissimilar plate joined by TIG welding

NASA Astrophysics Data System (ADS)

Sani, M. S. M.; Nazri, N. A.; Rani, M. N. Abdul; Yunus, M. A.

2018-04-01

In this paper, finite element (FE) joint modelling technique for prediction of dynamic properties of sheet metal jointed by tungsten inert gas (TTG) will be presented. I cross section dissimilar flat plate with different series of aluminium alloy; AA7075 and AA6061 joined by TTG are used. In order to find the most optimum set of TTG welding dissimilar plate, the finite element model with three types of joint modelling were engaged in this study; bar element (CBAR), beam element and spot weld element connector (CWELD). Experimental modal analysis (EMA) was carried out by impact hammer excitation on the dissimilar plates that welding by TTG method. Modal properties of FE model with joints were compared and validated with model testing. CWELD element was chosen to represent weld model for TTG joints due to its accurate prediction of mode shapes and contains an updating parameter for weld modelling compare to other weld modelling. Model updating was performed to improve correlation between EMA and FEA and before proceeds to updating, sensitivity analysis was done to select the most sensitive updating parameter. After perform model updating, average percentage of error of the natural frequencies for CWELD model is improved significantly.

A two-stage optimization model for emergency material reserve layout planning under uncertainty in response to environmental accidents.

PubMed

Liu, Jie; Guo, Liang; Jiang, Jiping; Jiang, Dexun; Liu, Rentao; Wang, Peng

2016-06-05

In the emergency management relevant to pollution accidents, efficiency emergency rescues can be deeply influenced by a reasonable assignment of the available emergency materials to the related risk sources. In this study, a two-stage optimization framework is developed for emergency material reserve layout planning under uncertainty to identify material warehouse locations and emergency material reserve schemes in pre-accident phase coping with potential environmental accidents. This framework is based on an integration of Hierarchical clustering analysis - improved center of gravity (HCA-ICG) model and material warehouse location - emergency material allocation (MWL-EMA) model. First, decision alternatives are generated using HCA-ICG to identify newly-built emergency material warehouses for risk sources which cannot be satisfied by existing ones with a time-effective manner. Second, emergency material reserve planning is obtained using MWL-EMA to make emergency materials be prepared in advance with a cost-effective manner. The optimization framework is then applied to emergency management system planning in Jiangsu province, China. The results demonstrate that the developed framework not only could facilitate material warehouse selection but also effectively provide emergency material for emergency operations in a quick response. Copyright © 2016. Published by Elsevier B.V.

Mobile Phone Ownership Is Not a Serious Barrier to Participation in Studies: Descriptive Study.

PubMed

Harvey, Emily J; Rubin, Leslie F; Smiley, Sabrina L; Zhou, Yitong; Elmasry, Hoda; Pearson, Jennifer L

2018-02-19

Rather than providing participants with study-specific data collection devices, their personal mobile phones are increasingly being used as a means for collecting geolocation and ecological momentary assessment (EMA) data in public health research. The purpose of this study was to (1) describe the sociodemographic characteristics of respondents to an online survey screener assessing eligibility to participate in a mixed methods study collecting geolocation and EMA data via the participants' personal mobile phones, and (2) examine how eligibility criteria requiring mobile phone ownership and an unlimited text messaging plan affected participant inclusion. Adult (≥18 years) daily smokers were recruited via public advertisements, free weekly newspapers, printed flyers, and word of mouth. An online survey screener was used as the initial method of determining eligibility for study participation. The survey screened for twenty-eight inclusion criteria grouped into three categories, which included (1) cell phone use, (2) tobacco use, and (3) additional criteria. A total of 1003 individuals completed the online screener. Respondents were predominantly African American (605/1003, 60.3%) (60.4%), male (514/1003, 51.3%), and had a median age of 35 years (IQR 26-50). Nearly 50% (496/1003, 49.5%) were unemployed. Most smoked menthol cigarettes (699/1003, 69.7%), and had a median smoking history of 11 years (IQR 5-21). The majority owned a mobile phone (739/1003, 73.7%), could install apps (86.8%), used their mobile phone daily (89.5%), and had an unlimited text messaging plan (871/1003, 86.8%). Of those who completed the online screener, 302 were eligible to participate in the study; 163 were eligible after rescreening, and 117 were enrolled in the study. Compared to employed individuals, a significantly greater proportion of those who were unemployed were ineligible for the study based on mobile phone inclusion criteria (P<.001); yet, 46.4% (333/717) of the individuals who were unemployed met all mobile phone inclusion criteria. Inclusion criteria requiring participants to use their personal mobile phones for data collection was not a major barrier to study participation for most respondents who completed the online screener, including those who were unemployed. ClinicalTrials.gov NCT02261363; https://clinicaltrials.gov/ct2/show/NCT02261363 (Archived by WebCite at http://www.webcitation.org/6wOmDluSt). ©Emily J Harvey, Leslie F Rubin, Sabrina L Smiley, Yitong Zhou, Hoda Elmasry, Jennifer L Pearson. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 19.02.2018.

Mobility Fuels for the Navy.

DTIC Science & Technology

1982-01-01

aircraft powered by gas turbines through the year 2000. The study also predicted that some types of diesels and steam powerplants could potentially...figure 3. Diesels are more efficient even at high- power settings. CHANGES TO FUELS Interrelationships between the price and quality of fuel have...emaIcal Physics 20 (1979) pp. 6446- PP 252 899), AD) A061 938 Nunn, Wolter R.. -Poeltion Finding with Prior Kowledge of .Eonrience Parameters," 5 pp., Jun

Comparison of Ecological Momentary Assessment Versus Direct Measurement of E-Cigarette Use With a Bluetooth-Enabled E-Cigarette: A Pilot Study.

PubMed

Pearson, Jennifer L; Elmasry, Hoda; Das, Babita; Smiley, Sabrina L; Rubin, Leslie F; DeAtley, Teresa; Harvey, Emily; Zhou, Yitong; Niaura, Raymond; Abrams, David B

2017-05-29

Assessing the frequency and intensity of e-cigarette use presents special challenges beyond those posed by cigarette use. Accurate measurement of e-cigarette consumption, puff duration, and the stability of these measures over time will be informative for estimating the behavioral and health effects of e-cigarette use. The purpose of this pilot study was to compare the accuracy of self-reported e-cigarette puff counts collected via ecological momentary assessment (EMA) to objective puff count data collected by a Bluetooth-enabled e-cigarette device and to examine the feasibility and acceptability of using a second-generation e-cigarette among adult smokers. A total of 5 adult smokers were enrolled in a longitudinal parent study assessing how e-cigarette use affects cigarette use among e-cigarette-naïve smokers. Using a text message-based EMA system, participants reported e-cigarette puffs for 2 weeks. Participants were also given a Bluetooth-enabled e-cigarette (Smokio) that passively collected puff counts and puff duration. Comparisons between mean reports of Smokio (device-report) and EMA (self-report) use were evaluated using paired t tests. Correlation and agreement between device- and self-reports were evaluated using Pearson correlation and the concordance correlation coefficient (CCC), respectively. A linear mixed effect model was used to determine the fixed effect of timing and Smokio-reported daily puffs on report accuracy. We examined the relationship between time of day and reporting accuracy using Tukey's test for multiple pairwise comparisons. A total of 5 African American participants, 4 men and 1 woman, who ranged in age from 24 to 59 years completed the study, resulting in 5180 observations (device-report) of e-cigarette use. At baseline, participants reported smoking for 5 to 25 years and consumed a mean of 7 to 13 cigarettes per day (CPD); 4 smoked within 30 minutes of waking. At the 30-day follow-up, CPD range decreased to 1 to 3 cigarettes; 4 participants reported past 7-day e-cigarette use, and 1 participant reported no cigarette smoking in the past 7 days. Over 2 weeks of e-cigarette use, participants took an average of 1074 e-cigarette (SD 779.0) puffs per person as captured by the device reports. Each participant took a mean of 75.0 (SD 58.8) puffs per day, with each puff lasting an average of 3.6 (SD 2.4) seconds. Device reports captured an average of 33.3 (SD 47.8) more puffs per person per day than the self-reported e-cigarette puffs. In 87% of days, participants underestimated the number of puffs they had taken on the Smokio. There was significant moderate correlation (r=.47, P<.001) but poor agreement (p c =0.31, 95% CI 0.15-0.46) between the device- and self-reported data. Reporting accuracy was affected by amount and timing of e-cigarette use. Compared to self-reported e-cigarette use, the Bluetooth-enabled device captured significantly more e-cigarette use and allowed for examination of puff duration in addition to puff counts. A Bluetooth-enabled e-cigarette is a powerful and feasible tool for objective collection of e-cigarette use behavior in the real world. ©Jennifer L Pearson, Hoda Elmasry, Babita Das, Sabrina L Smiley, Leslie F Rubin, Teresa DeAtley, Emily Harvey, Yitong Zhou, Raymond Niaura, David B Abrams. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 29.05.2017.

Comparison of Ecological Momentary Assessment Versus Direct Measurement of E-Cigarette Use With a Bluetooth-Enabled E-Cigarette: A Pilot Study

PubMed Central

Elmasry, Hoda; Das, Babita; Smiley, Sabrina L; Rubin, Leslie F; DeAtley, Teresa; Harvey, Emily; Zhou, Yitong; Niaura, Raymond; Abrams, David B

2017-01-01

Background Assessing the frequency and intensity of e-cigarette use presents special challenges beyond those posed by cigarette use. Accurate measurement of e-cigarette consumption, puff duration, and the stability of these measures over time will be informative for estimating the behavioral and health effects of e-cigarette use. Objective The purpose of this pilot study was to compare the accuracy of self-reported e-cigarette puff counts collected via ecological momentary assessment (EMA) to objective puff count data collected by a Bluetooth-enabled e-cigarette device and to examine the feasibility and acceptability of using a second-generation e-cigarette among adult smokers. Methods A total of 5 adult smokers were enrolled in a longitudinal parent study assessing how e-cigarette use affects cigarette use among e-cigarette–naïve smokers. Using a text message–based EMA system, participants reported e-cigarette puffs for 2 weeks. Participants were also given a Bluetooth-enabled e-cigarette (Smokio) that passively collected puff counts and puff duration. Comparisons between mean reports of Smokio (device-report) and EMA (self-report) use were evaluated using paired t tests. Correlation and agreement between device- and self-reports were evaluated using Pearson correlation and the concordance correlation coefficient (CCC), respectively. A linear mixed effect model was used to determine the fixed effect of timing and Smokio-reported daily puffs on report accuracy. We examined the relationship between time of day and reporting accuracy using Tukey's test for multiple pairwise comparisons. Results A total of 5 African American participants, 4 men and 1 woman, who ranged in age from 24 to 59 years completed the study, resulting in 5180 observations (device-report) of e-cigarette use. At baseline, participants reported smoking for 5 to 25 years and consumed a mean of 7 to 13 cigarettes per day (CPD); 4 smoked within 30 minutes of waking. At the 30-day follow-up, CPD range decreased to 1 to 3 cigarettes; 4 participants reported past 7-day e-cigarette use, and 1 participant reported no cigarette smoking in the past 7 days. Over 2 weeks of e-cigarette use, participants took an average of 1074 e-cigarette (SD 779.0) puffs per person as captured by the device reports. Each participant took a mean of 75.0 (SD 58.8) puffs per day, with each puff lasting an average of 3.6 (SD 2.4) seconds. Device reports captured an average of 33.3 (SD 47.8) more puffs per person per day than the self-reported e-cigarette puffs. In 87% of days, participants underestimated the number of puffs they had taken on the Smokio. There was significant moderate correlation (r=.47, P<.001) but poor agreement (pc=0.31, 95% CI 0.15-0.46) between the device- and self-reported data. Reporting accuracy was affected by amount and timing of e-cigarette use. Conclusions Compared to self-reported e-cigarette use, the Bluetooth-enabled device captured significantly more e-cigarette use and allowed for examination of puff duration in addition to puff counts. A Bluetooth-enabled e-cigarette is a powerful and feasible tool for objective collection of e-cigarette use behavior in the real world. PMID:28554877

Ecological momentary assessment for chronic pain in fibromyalgia using a smartphone: a randomized crossover study.

PubMed

Garcia-Palacios, A; Herrero, R; Belmonte, M A; Castilla, D; Guixeres, J; Molinari, G; Baños, R M

2014-07-01

Daily diaries are a useful way of measuring fluctuations in pain-related symptoms. However, traditional diaries do not assure the gathering of data in real time, not solving the problem of retrospective assessment. Ecological momentary assessment (EMA) by means of electronic diaries helps to improve repeated assessment. However, it is important to test its feasibility in specific populations in order to reach a wider number of people who could benefit from these procedures. The present study compares the compliance and acceptability of an electronic diary running on a smartphone using a crossover design for a sample with a specific pain condition, fibromyalgia and low familiarity with technology. Forty-seven participants were randomly assigned to one of two conditions: (1) paper diary - smartphone diary and (2) smartphone diary - paper diary, using each assessment method for 1 week. The findings of this study showed that the smartphone diary made it possible to gather more accurate and complete ratings. Besides, this method was well accepted by a sample of patients with fibromyalgia referred by a public hospital, with an important proportion of participants with low level of education and low familiarity with technology. The findings of this study support the use of smartphones for EMA even in specific populations with a specific pain condition, fibromyalgia and with low familiarity with technology. These methods could help clinicians and researchers to gather more accurate ratings of relevant pain-related variables even in populations with low familiarity with technology.

[Dissection of differences and similarities of botanical drugs in European Union, US and Canada].

PubMed

He, Yi; Zhao, Libin; Ye, Zhengliang; Guo, Zhixin; Sun, He

2011-10-01

Because of the unique nature and treatment concept of traditional Chinese medicines (TCMs), TCMs have been respected again since 70s of last century. The regulatory agencies of some developed countries (the FDA, EMA and Health Canada etc) have published new guidance/guidelines/directives in recent years, such as the botanical drug product guidance of the FDA, the evidence for quality of finished natural health products guidance of the Health Canada and the guideline on quality of herbal medicinal products/ traditional herbal medicinal products of the EMA etc. All of the regulatory agencies are willing to scientifically evaluate the herbal medicines and accept it as therapeutic product. This paper analyzed the history of herbal medicine regulation and the similarities and differences of the regulatory requirements of the European Union, the United States and Canada, proposed possible future direction of the international development of Chinese medicine from the perspective of global regulatory affairs.

Social media best practices in emergency management.

PubMed

Siskey, Ashley; Islam, Tanveer

2016-01-01

Social media platforms have become popular as means of communications in emergency management. Many people use social media sites such as Facebook and Twitter on a daily basis including during disaster events. Emergency management agencies (EMAs) need to recognize the value of not only having a presence on social media but also actively engaging stakeholders and the public on these sites. However, identifying best practices for the use of social media in emergency management is still in its infancy. The objective of this article is to begin to create or further define best practices for emergency managers to use social media sites particularly Facebook and Twitter in four key areas: 1) implementation, 2) education, 3) collaboration, and 4) communication. A list of recommendations of best practices is formulated for each key area and results from a nationwide survey on the use of social media by county EMAs are discussed in this article.

Realizing high-quality ultralarge momentum states and ultrafast topological transitions using semiconductor hyperbolic metamaterials

DOE PAGES

Campione, Salvatore; Liu, Sheng; Luk, Ting S.; ...

2015-08-05

We employ both the effective medium approximation (EMA) and Bloch theory to compare the dispersion properties of semiconductor hyperbolic metamaterials (SHMs) at mid-infrared frequencies and metallic hyperbolic metamaterials (MHMs) at visible frequencies. This analysis reveals the conditions under which the EMA can be safely applied for both MHMs and SHMs. We find that the combination of precise nanoscale layering and the longer infrared operating wavelengths puts the SHMs well within the effective medium limit and, in contrast to MHMs, allows for the attainment of very high photon momentum states. Additionally, SHMs allow for new phenomena such as ultrafast creation ofmore » the hyperbolic manifold through optical pumping. Furthermore, we examine the possibility of achieving ultrafast topological transitions through optical pumping which can photo-dope appropriately designed quantum wells on the femtosecond time scale.« less

Thrust vector control using electric actuation

NASA Astrophysics Data System (ADS)

Bechtel, Robert T.; Hall, David K.

1995-01-01

Presently, gimbaling of launch vehicle engines for thrust vector control is generally accomplished using a hydraulic system. In the case of the space shuttle solid rocket boosters and main engines, these systems are powered by hydrazine auxiliary power units. Use of electromechanical actuators would provide significant advantages in cost and maintenance. However, present energy source technologies such as batteries are heavy to the point of causing significant weight penalties. Utilizing capacitor technology developed by the Auburn University Space Power Institute in collaboration with the Auburn CCDS, Marshall Space Flight Center (MSFC) and Auburn are developing EMA system components with emphasis on high discharge rate energy sources compatible with space shuttle type thrust vector control requirements. Testing has been done at MSFC as part of EMA system tests with loads up to 66000 newtons for pulse times of several seconds. Results show such an approach to be feasible providing a potential for reduced weight and operations costs for new launch vehicles.

Summary report of PQRI Workshop on Nanomaterial in Drug Products: current experience and management of potential risks.

PubMed

Bartlett, Jeremy A; Brewster, Marcus; Brown, Paul; Cabral-Lilly, Donna; Cruz, Celia N; David, Raymond; Eickhoff, W Mark; Haubenreisser, Sabine; Jacobs, Abigail; Malinoski, Frank; Morefield, Elaine; Nalubola, Ritu; Prud'homme, Robert K; Sadrieh, Nakissa; Sayes, Christie M; Shahbazian, Hripsime; Subbarao, Nanda; Tamarkin, Lawrence; Tyner, Katherine; Uppoor, Rajendra; Whittaker-Caulk, Margaret; Zamboni, William

2015-01-01

At the Product Quality Research Institute (PQRI) Workshop held last January 14-15, 2014, participants from academia, industry, and governmental agencies involved in the development and regulation of nanomedicines discussed the current state of characterization, formulation development, manufacturing, and nonclinical safety evaluation of nanomaterial-containing drug products for human use. The workshop discussions identified areas where additional understanding of material attributes, absorption, biodistribution, cellular and tissue uptake, and disposition of nanosized particles would continue to inform their safe use in drug products. Analytical techniques and methods used for in vitro characterization and stability testing of formulations containing nanomaterials were discussed, along with their advantages and limitations. Areas where additional regulatory guidance and material characterization standards would help in the development and approval of nanomedicines were explored. Representatives from the US Food and Drug Administration (USFDA), Health Canada, and European Medicines Agency (EMA) presented information about the diversity of nanomaterials in approved and newly developed drug products. USFDA, Health Canada, and EMA regulators discussed the applicability of current regulatory policies in presentations and open discussion. Information contained in several of the recent EMA reflection papers was discussed in detail, along with their scope and intent to enhance scientific understanding about disposition, efficacy, and safety of nanomaterials introduced in vivo and regulatory requirements for testing and market authorization. Opportunities for interaction with regulatory agencies during the lifecycle of nanomedicines were also addressed at the meeting. This is a summary of the workshop presentations and discussions, including considerations for future regulatory guidance on drug products containing nanomaterials.

A generalised multiple-mass based method for the determination of the live mass of a force transducer

NASA Astrophysics Data System (ADS)

Montalvão, Diogo; Baker, Thomas; Ihracska, Balazs; Aulaqi, Muhammad

2017-01-01

Many applications in Experimental Modal Analysis (EMA) require that the sensors' masses are known. This is because the added mass from sensors will affect the structural mode shapes, and in particular its natural frequencies. EMA requires the measurement of the exciting forces at given coordinates, which is often made using piezoelectric force transducers. In such a case, the live mass of the force transducer, i.e. the mass as 'seen' by the structure in perpendicular directions must be measured somehow, so that compensation methods like mass cancelation can be performed. This however presents a problem on how to obtain an accurate measurement for the live mass. If the system is perfectly calibrated, then a reasonably accurate estimate can be made using a straightforward method available in most classical textbooks based on Newton's second law. However, this is often not the case (for example when the transducer's sensitivity changed over time, when it is unknown or when the connection influences the transmission of the force). In a self-calibrating iterative method, both the live mass and calibration factor are determined, but this paper shows that the problem may be ill-conditioned, producing misleading results if certain conditions are not met. Therefore, a more robust method is presented and discussed in this paper, reducing the ill-conditioning problems and the need to know the calibration factors beforehand. The three methods will be compared and discussed through numerical and experimental examples, showing that classical EMA still is a field of research that deserves the attention from scientists and engineers.

[Prevention and treatment of venous thromboembolism: the place of new oral anticoagulants].

PubMed

Reis, Abílio

2012-04-01

Venous thromboembolism (VTE) is still an important problem of Public Health, due to its impact in terms of morbidity, mortality, resource allocation and associated costs. In the prevention and treatment of VTE, pharmacological therapy is well defined and efficacious but has some inconveniences that leave space for improvement. Several new oral anticoagulants are being developed and tested for the prevention and treatment of VTE. The better studied are the selective Factor Xa inhibitors apixaban, rivaroxaban and edoxaban, and the thrombin antagonist dabigatran. They all are orally administrated, don't have important interactions with food or other drugs, have a convenient fixed-dose regimen and a predictable action, and dispense routine monitoring of their anticoagulant effect. The major part of them has phase III studies concluded and published. Some of them are already approved by de European Medicines Agency (EMA) and the Food and Drug Administration (FDA) and recommended by the international guidelines. Rivaroxaban is approved by the EMA for the treatment of deep venous thrombosis (DVT) and for the prevention of recurrences of DVT and pulmonary embolism. In this article the available evidences are reviewed, the place of the new oral anticoagulants is discussed and future perspectives regarding the prevention and treatment of VTE are outlined. Copyright © 2012 Sociedade Portuguesa de Cardiologia. Published by Elsevier España. All rights reserved.

Marijuana use, craving, and academic motivation and performance among college students: An in-the-moment study.

PubMed

Phillips, Kristina T; Phillips, Michael M; Lalonde, Trent L; Tormohlen, Kayla N

2015-08-01

Marijuana is the most commonly used illicit substance in the U.S., with high rates among young adults in the state of Colorado. Chronic, heavy marijuana use can impact cognitive functioning, which has the potential to influence academic performance of college students. It is possible that craving for marijuana may further contribute to diminished cognitive and affective functioning, thus leading to poor outcomes for students. College student marijuana users (n=57) were recruited based on heavy use and completed ecological momentary assessment (EMA) via text-messaging. The association between marijuana use and craving in a college setting was explored, as well as how these variables might relate to academic motivation, effort and success. The participants were sent text messages for two weeks, three times per day at random times. A temporal association between craving and marijuana use was found, where momentary craving positively predicted greater marijuana use. Similarly, as craving levels increased, the number of minutes spent studying decreased at the next assessment point. A negative association between momentary craving for marijuana and academic motivation was found in the same moment. Greater academic self-efficacy positively predicted cumulative GPA, while average minutes spent smoking marijuana was negatively related. Using EMA, marijuana craving and use were significantly related. These findings provide further evidence that heavy marijuana use is negatively associated with academic outcomes. Copyright © 2015 Elsevier Ltd. All rights reserved.

Investigating the Dynamics of Suicidal Ideation.

PubMed

Hallensleben, Nina; Spangenberg, Lena; Forkmann, Thomas; Rath, Dajana; Hegerl, Ulrich; Kersting, Anette; Kallert, Thomas W; Glaesmer, Heide

2018-01-01

Although the fluctuating nature of suicidal ideation (SI) has been described previously, longitudinal studies investigating the dynamics of SI are scarce. To demonstrate the fluctuation of SI across 6 days and up to 60 measurement points using smartphone-based ecological momentary assessments (EMA). Twenty inpatients with unipolar depression and current and/or lifetime suicidal ideation rated their momentary SI 10 times per day over a 6-day period. Mean squared successive difference (MSSD) was calculated as a measure of variability. Correlations of MSSD with severity of depression, number of previous depressive episodes, and history of suicidal behavior were examined. Individual trajectories of SI are shown to illustrate fluctuation. MSSD values ranged from 0.2 to 21.7. No significant correlations of MSSD with several clinical parameters were found, but there are hints of associations between fluctuation of SI and severity of depression and suicidality. Main limitation of this study is the small sample size leading to low power and probably missing potential effects. Further research with larger samples is necessary to shed light on the dynamics of SI. The results illustrate the dynamic nature and the diversity of trajectories of SI across 6 days in psychiatric inpatients with unipolar depression. Prediction of the fluctuation of SI might be of high clinical relevance. Further research using EMA and sophisticated analyses with larger samples is necessary to shed light on the dynamics of SI.

Development of a soft ground arrestor system.

DOT National Transportation Integrated Search

2008-08-15

Increase in the demand for air travel safety has promoted the development of Ground Arrestor Systems (GAS). Currently, GAS has been deployed in many of the airports : throughout America and is called as Engineered Material Arrestor System (EMAS). The...

Analytical Challenges and Regulatory Requirements for Nasal Drug Products in Europe and the U.S.

PubMed Central

Trows, Sabrina; Wuchner, Klaus; Spycher, Rene; Steckel, Hartwig

2014-01-01

Nasal drug delivery can be assessed by a variety of means and regulatory agencies, e.g., the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have published a set of guidelines and regulations proposing in vitro test methods for the characterization of nasal drug products. This article gives a summary of the FDA and EMA requirements regarding the determination of droplet size distribution (DSD), plume geometry, spray pattern and shot weights of solution nasal sprays and discusses the analytical challenges that can occur when performing these measurements. In order to support findings from the literature, studies were performed using a standard nasal spray pump and aqueous model formulations. The aim was to identify possible method-, device- and formulation-dependent influencing factors. The literature review, as well as the results from the studies show that DSD, plume geometry and spray pattern are influenced by, e.g., the viscosity of the solution, the design of the device and the actuation parameters, particularly the stroke length, actuation velocity and actuation force. The dominant factor influencing shot weights, however, is the adjustment of the actuation parameters, especially stroke length and actuation velocity. Consequently, for routine measurements assuring, e.g., the quality of a solution nasal spray or, for in vitro bioequivalence studies, the critical parameters, have to be identified and considered in method development in order to obtain reproducible and reliable results. PMID:24732068

Ecological momentary assessment of acute alcohol use disorder symptoms: associations with mood, motives, and use on planned drinking days.

PubMed

Dvorak, Robert D; Pearson, Matthew R; Day, Anne M

2014-08-01

Several theories posit that alcohol is consumed both in relation to one's mood and in relation to different motives for drinking. However, there are mixed findings regarding the role of mood and motives in predicting drinking. Ecological momentary assessment (EMA) methods provide an opportunity to evaluate near real-time changes in mood and motives within individuals to predict alcohol use. In addition, endorsement of criteria of an alcohol use disorder (AUD) may also be sensitive to changes within subjects. The current study used EMA with 74 moderate drinkers who responded to fixed and random mood, motive, alcohol use, and AUD criteria prompts over a 21-day assessment period. A temporal pattern of daytime mood, evening drinking motivation, and nighttime alcohol use and acute AUD symptoms on planned drinking days was modeled to examine how these associations unfold throughout the day. The results suggest considerable heterogeneity in drinking motivation across drinking days. Additionally, an affect regulation model of drinking to cope with negative mood was observed. Specifically, on planned drinking days, the temporal association between daytime negative mood and the experience of acute AUD symptoms was mediated via coping motives and alcohol use. The current study found that motives are dynamic, and that changes in motives may predict differential drinking patterns across days. Further, the study provides evidence that emotion-regulation-driven alcohol involvement may need to be examined at the event level to fully capture the ebb and flow of negative affect motivated drinking.

Burden of celiac disease in Europe: a review of its childhood and adulthood prevalence and incidence as of September 2014.

PubMed

Altobelli, E; Paduano, R; Petrocelli, R; Di Orio, F

2014-01-01

Recent epidemiological studies have demonstrated that coeliac disease (CD) prevalence is still underestimated both in Europe and in Mediterranean regions. Here we review the latest data on CD prevalence and incidence in the European Union (EU) as of September 2014. The current epidemiological scenario of CD prevalence and incidence was investigated by searching PubMed for papers in English using the following key words: "celiac disease", "celiac disease plus prevalence" (limits: 1990-2014), "incidence" (limits: 1970-2014), and "frequency", plus "in Europe". Another search was performed with the same key words plus the name of each European country. Only prevalence data obtained by serology using anti-gliadin antibodies (AGA), EMA test, tTG test, and/or duodenal biopsy were included. The study designs considered were retrospective and prospective studies: population-based (PB), cross-sectional, case-control and cohort studies. Extensive research based on serological screening has demonstrated that 0.5-1% of the EU population suffers from undiagnosed CD, whereas the highest estimate reported in PB studies is approximately 1%. Considering data from different periods, incidence seems to range from 0.1 to 3.7/1000 live births in the child population and from 1.3 to 39/100,000/year in the adult population. The present data disclose marked geographical variation in CD incidence and prevalence in different European countries. Here we document rising CD occurrence in recent decades in European countries due partly to the advent of improved serological testing (tTG + EMA) and partly to increased awareness of its clinical presentation.

Relations among affect, abstinence motivation and confidence, and daily smoking lapse risk.

PubMed

Minami, Haruka; Yeh, Vivian M; Bold, Krysten W; Chapman, Gretchen B; McCarthy, Danielle E

2014-06-01

This study tested the hypothesis that changes in momentary affect, abstinence motivation, and confidence would predict lapse risk over the next 12-24 hr using Ecological Momentary Assessment (EMA) data from smokers attempting to quit smoking. One hundred and three adult, daily, treatment-seeking smokers recorded their momentary affect, motivation to quit, abstinence confidence, and smoking behaviors in near real time with multiple EMA reports per day using electronic diaries postquit. Multilevel models indicated that initial levels of negative affect were associated with smoking, even after controlling for earlier smoking status, and that short-term increases in negative affect predicted lapses up to 12, but not 24, hr later. Positive affect had significant effects on subsequent abstinence confidence, but not motivation to quit. High levels of motivation appeared to reduce increases in lapse risk that occur over hours although momentary changes in confidence did not predict lapse risk over 12 hr. Negative affect had short-lived effects on lapse risk, whereas higher levels of motivation protected against the risk of lapsing that accumulates over hours. An increase in positive affect was associated with greater confidence to quit, but such changes in confidence did not reduce short-term lapse risk, contrary to expectations. Relations observed among affect, cognitions, and lapse seem to depend critically on the timing of assessments.

Inflation of the type I error: investigations on regulatory recommendations for bioequivalence of highly variable drugs.

PubMed

Wonnemann, Meinolf; Frömke, Cornelia; Koch, Armin

2015-01-01

We investigated different evaluation strategies for bioequivalence trials with highly variable drugs on their resulting empirical type I error and empirical power. The classical 'unscaled' crossover design with average bioequivalence evaluation, the Add-on concept of the Japanese guideline, and the current 'scaling' approach of EMA were compared. Simulation studies were performed based on the assumption of a single dose drug administration while changing the underlying intra-individual variability. Inclusion of Add-on subjects following the Japanese concept led to slight increases of the empirical α-error (≈7.5%). For the approach of EMA we noted an unexpected tremendous increase of the rejection rate at a geometric mean ratio of 1.25. Moreover, we detected error rates slightly above the pre-set limit of 5% even at the proposed 'scaled' bioequivalence limits. With the classical 'unscaled' approach and the Japanese guideline concept the goal of reduced subject numbers in bioequivalence trials of HVDs cannot be achieved. On the other hand, widening the acceptance range comes at the price that quite a number of products will be accepted bioequivalent that had not been accepted in the past. A two-stage design with control of the global α therefore seems the better alternative.

Soil chemical factors and grassland species density in Emas National Park (central Brazil).

PubMed

Amorim, P K; Batalha, M A

2008-05-01

Studies of grasslands on specific soil types suggest that different nutrients can limit biomass production and, hence, species composition and number. The Brazilian cerrado is the major savanna region in America and once covered about 2 million km(2), mainly in the Brazilian Central Plateau, under seasonal climate, with wet summer and dry winter. In view of the importance of soil chemical factors in the distribution of the vegetation forms within the Cerrado domain and which may influence the number of species, we analyzed some soil characteristics in three herbaceous vegetation forms -- hyperseasonal cerrado, seasonal cerrado, and wet grassland -- in Emas National Park, a core cerrado site, to investigate the relationship between number of species and soil characteristics. We collected vegetation and soil samples in these three vegetation forms and submitted the obtained data to multiple linear regression. We found out that aluminum and pH were the best predictors of species density, the former positively related to species density and the latter negatively related. Since the predictable variation in species density is important in determining areas of conservation, we can postulate that these two soil factors are indicators of high species density areas in tropical grasslands, which could be used in selecting priority sites for conservation.

Validated low-volume aldosterone immunoassay tailored to GCLP-compliant investigations in small sample volumes.

PubMed

Schaefer, J; Burckhardt, B B; Tins, J; Bartel, A; Laeer, S

2017-12-01

Heart failure is well investigated in adults, but data in children is lacking. To overcome this shortage of reliable data, appropriate bioanalytical assays are required. Development and validation of a bioanalytical assay for the determination of aldosterone concentrations in small sample volumes applicable to clinical studies under Good Clinical Laboratory Practice. An immunoassay was developed based on a commercially available enzyme-linked immunosorbent assay and validated according to current bioanalytical guidelines of the EMA and FDA. The assay (range 31.3-1000 pg/mL [86.9-2775 pmol/L]) is characterized by a between-run accuracy from - 3.8% to - 0.8% and a between-run imprecision ranging from 4.9% to 8.9% (coefficient of variation). For within-run accuracy, the relative error was between - 11.1% and + 9.0%, while within-run imprecision ranged from 1.2% to 11.8% (CV). For parallelism and dilutional linearity, the relative error of back-calculated concentrations varied from - 14.1% to + 8.4% and from - 7.4% to + 10.5%, respectively. The immunoassay is compliant with the bioanalytical guidelines of the EMA and FDA and allows accurate and precise aldosterone determinations. As the assay can run low-volume samples, it is especially valuable for pediatric investigations.

Simulation of crash tests for high impact levels of a new bridge safety barrier

NASA Astrophysics Data System (ADS)

Drozda, Jiří; Rotter, Tomáš

2017-09-01

The purpose is to show the opportunity of a non-linear dynamic impact simulation and to explain the possibility of using finite element method (FEM) for developing new designs of safety barriers. The main challenge is to determine the means to create and validate the finite element (FE) model. The results of accurate impact simulations can help to reduce necessary costs for developing of a new safety barrier. The introductory part deals with the creation of the FE model, which includes the newly-designed safety barrier and focuses on the application of an experimental modal analysis (EMA). The FE model has been created in ANSYS Workbench and is formed from shell and solid elements. The experimental modal analysis, which was performed on a real pattern, was employed for measuring the modal frequencies and shapes. After performing the EMA, the FE mesh was calibrated after comparing the measured modal frequencies with the calculated ones. The last part describes the process of the numerical non-linear dynamic impact simulation in LS-DYNA. This simulation was validated after comparing the measured ASI index with the calculated ones. The aim of the study is to improve professional public knowledge about dynamic non-linear impact simulations. This should ideally lead to safer, more accurate and profitable designs.

Log Pearson type 3 quantile estimators with regional skew information and low outlier adjustments

USGS Publications Warehouse

Griffis, V.W.; Stedinger, Jery R.; Cohn, T.A.

2004-01-01

The recently developed expected moments algorithm (EMA) [Cohn et al., 1997] does as well as maximum likelihood estimations at estimating log‐Pearson type 3 (LP3) flood quantiles using systematic and historical flood information. Needed extensions include use of a regional skewness estimator and its precision to be consistent with Bulletin 17B. Another issue addressed by Bulletin 17B is the treatment of low outliers. A Monte Carlo study compares the performance of Bulletin 17B using the entire sample with and without regional skew with estimators that use regional skew and censor low outliers, including an extended EMA estimator, the conditional probability adjustment (CPA) from Bulletin 17B, and an estimator that uses probability plot regression (PPR) to compute substitute values for low outliers. Estimators that neglect regional skew information do much worse than estimators that use an informative regional skewness estimator. For LP3 data the low outlier rejection procedure generally results in no loss of overall accuracy, and the differences between the MSEs of the estimators that used an informative regional skew are generally modest in the skewness range of real interest. Samples contaminated to model actual flood data demonstrate that estimators which give special treatment to low outliers significantly outperform estimators that make no such adjustment.

Log Pearson type 3 quantile estimators with regional skew information and low outlier adjustments

NASA Astrophysics Data System (ADS)

Griffis, V. W.; Stedinger, J. R.; Cohn, T. A.

2004-07-01

The recently developed expected moments algorithm (EMA) [, 1997] does as well as maximum likelihood estimations at estimating log-Pearson type 3 (LP3) flood quantiles using systematic and historical flood information. Needed extensions include use of a regional skewness estimator and its precision to be consistent with Bulletin 17B. Another issue addressed by Bulletin 17B is the treatment of low outliers. A Monte Carlo study compares the performance of Bulletin 17B using the entire sample with and without regional skew with estimators that use regional skew and censor low outliers, including an extended EMA estimator, the conditional probability adjustment (CPA) from Bulletin 17B, and an estimator that uses probability plot regression (PPR) to compute substitute values for low outliers. Estimators that neglect regional skew information do much worse than estimators that use an informative regional skewness estimator. For LP3 data the low outlier rejection procedure generally results in no loss of overall accuracy, and the differences between the MSEs of the estimators that used an informative regional skew are generally modest in the skewness range of real interest. Samples contaminated to model actual flood data demonstrate that estimators which give special treatment to low outliers significantly outperform estimators that make no such adjustment.

Perceived neighborhood characteristics predict severity and emotional response to daily stressors.

PubMed

Scott, Stacey B; Munoz, Elizabeth; Mogle, Jacqueline A; Gamaldo, Alyssa A; Smyth, Joshua M; Almeida, David M; Sliwinski, Martin J

2018-03-01

Neighborhood characteristics may influence health and well-being outcomes through stressors in daily life. This study tested whether a varied set of perceived characteristics of neighborhood (i.e., social cohesion, safety, aesthetic quality, violence) predicted stressor frequency and severity as well as negative emotional responses to stressors. We predicted greater reported cohesion and safety and less violence would be associated with less frequent stressor exposure and severity and less intense negative affect following stressors; we conducted subsequent tests of neighborhood aesthetic quality as a predictor. Participants (n = 233, age 25-65 years) were residents in a socio-economically, racially, and ethnically diverse zip code in Bronx, New York, most who participated in the Effects of Stress on Cognitive Aging, Physiology and Emotion study between 2012 and 2013. They provided demographic information and neighborhood ratings, then participated in the EMA protocol in which they completed brief smartphone surveys of current negative affect and stressor exposure, severity, and recency, five times daily for 14 days. No coded neighborhood characteristic was related to the frequency of stressors. Individuals who reported greater neighborhood violence, however, rated their stressors as more severe. Individuals rating their neighborhood lower in safety or aesthetic quality, or higher in violence, had greater negative affect following stressors. Even among people living within the same zip code, individual differences in perceptions of neighborhood predict how stressful they appraised stressors in daily life to be and how much negative affect they reported following stressors. Copyright © 2017 Elsevier Ltd. All rights reserved.

Lithofacies, age, depositional setting, and geochemistry of the Otuk Formation in the Red Dog District, northwestern Alaska

USGS Publications Warehouse

Dumoulin, Julie A.; Burruss, Robert A.; Blome, Charles D.

2013-01-01

Complete penetration of the Otuk Formation in a continuous drill core (diamond-drill hole, DDH 927) from the Red Dog District illuminates the facies, age, depositional environment, source rock potential, and isotope stratigraphy of this unit in northwestern Alaska. The section, in the Wolverine Creek plate of the Endicott Mountains Allochthon (EMA), is ~82 meters (m) thick and appears structurally uncomplicated. Bedding dips are generally low and thicknesses recorded are close to true thicknesses. Preliminary synthesis of sedimentologic, paleontologic, and isotopic data suggests that the Otuk succession in DDH 927 is a largely complete, albeit condensed, marine Triassic section in conformable contact with marine Permian and Jurassic strata. The Otuk Formation in DDH 927 gradationally overlies gray siliceous mudstone of the Siksikpuk Formation (Permian, based on regional correlations) and underlies black organic-rich mudstone of the Kingak(?) Shale (Jurassic?, based on regional correlations). The informal shale, chert, and limestone members of the Otuk are recognized in DDH 927, but the Jurassic Blankenship Member is absent. The lower (shale) member consists of 28 m of black to light gray, silty shale with as much as 6.9 weight percent total organic carbon (TOC). Thin limy layers near the base of this member contain bivalve fragments (Claraia sp.?) consistent with an Early Triassic (Griesbachian-early Smithian) age. Gray radiolarian chert dominates the middle member (25 m thick) and yields radiolarians of Middle Triassic (Anisian and Ladinian) and Late Triassic (Carnian-late middle Norian) ages. Black to light gray silty shale, like that in the lower member, forms interbeds that range from a few millimeters to 7 centimeters in thickness through much of the middle member. A distinctive, 2.4-m-thick interval of black shale and calcareous radiolarite ~17 m above the base of the member has as much as 9.8 weight percent TOC, and a 1.9-m-thick interval of limy to cherty mudstone immediately above this contains radiolarians, foraminifers, conodonts, and halobiid bivalve fragments. The upper (limestone) member (29 m thick) is lime mudstone with monotid bivalves and late Norian radiolarians, overlain by gray chert that contains Rhaetian (latest Triassic) radiolarians; Rhaetian strata have not previously been documented in the Otuk. Rare gray to black shale interbeds in the upper member have as much as 3.4 weight percent TOC. At least 35 m of black mudstone overlies the limestone member; these strata lack interbeds of oil shale and chert that are characteristic of the Blankenship, and instead they resemble the Kingak Shale. Vitrinite reflectance values (2.45 and 2.47 percent Ro) from two samples of black shale in the chert member indicate that these rocks reached a high level of thermal maturity within the dry gas window. Regional correlations indicate that lithofacies in the Otuk Formation vary with both structural and geographic position. For example, the shale member of the Otuk in the Wolverine Creek plate includes more limy layers and less barite (as blades, nodules, and lenses) than equivalent strata in the structurally higher Red Dog plate of the EMA, but it has fewer limy layers than the shale member in the EMA ~450 kilometers (km) to the east at Tiglukpuk Creek. The limestone member of the Otuk is thicker in the Wolverine Creek plate than in the Red Dog plate and differs from this member in EMA sections to the east in containing an upper cherty interval that lacks monotids; a similar interval is seen at the top of the Otuk Formation ~125 km to the west (Lisburne Peninsula). Our observations are consistent with the interpretations of previous researchers that Otuk facies become more distal in higher structural positions and that within a given structural level more distal facies occur to the west. Recent paleogeographic reconstructions indicate that the Otuk accumulated at a relatively high paleolatitude with a bivalve fauna typical of the Boreal realm. A suite of δ13Corg (carbon isotopic composition of carbon) data (n=38) from the upper Siksikpuk Formation through the Otuk Formation and into the Kingak(?) Shale in DDH 927 shows a pattern of positive and negative excursions similar to those reported elsewhere in Triassic strata. In particular, a distinct negative excursion at the base of the Otuk (from ‒23.8 to ‒31.3‰ (permil, or parts per thousand)) likely correlates with a pronounced excursion that marks the Permian-Triassic boundary at many localities worldwide. Another feature of the Otuk δ13Corg record that may correlate globally is a series of negative and positive excursions in the lower member. At the top of the Otuk in DDH 927, the δ13Corg values are extremely low and may correlate with a negative excursion that is widely observed at the Triassic-Jurassic boundary.

[Gradient of serotonergic innervation of internal organs].

PubMed

Lychkova, A E

2004-01-01

The unidirectional synergistic effect of the vegetative nervous system departments was studied at the regulation of the activity of internal organs. It was shown that the sympathetic nerve intensification of the vagal stimulation of EMA of stomach, urinary bladder, ureters, uteruss, fallopian tubes and deferent duct is realized by means of activation of serotonergic fibrae preganglionares that transmit the activation to 5-NTS,4 serotonin receptors of intramural ganglia that, in their turn, activate 5-NT1,2 serotonin receptors of effector cells.

An Ecological Momentary Intervention for Smoking Cessation: Evaluation of Feasibility and Effectiveness.

PubMed

Businelle, Michael S; Ma, Ping; Kendzor, Darla E; Frank, Summer G; Vidrine, Damon J; Wetter, David W

2016-12-12

Despite substantial public health progress in reducing the prevalence of smoking in the United States overall, smoking among socioeconomically disadvantaged adults remains high. To determine the feasibility and preliminary effectiveness of a novel smartphone-based smoking cessation app designed for socioeconomically disadvantaged smokers. Participants were recruited from a safety-net hospital smoking cessation clinic in Dallas, Texas, and were followed for 13 weeks. All participants received standard smoking cessation clinic care (ie, group counseling and cessation pharmacotherapy) and a smartphone with a novel smoking cessation app (ie, Smart-T). The Smart-T app prompted 5 daily ecological momentary assessments (EMAs) for 3 weeks (ie, 1 week before cessation and 2 weeks after cessation). During the precessation period, EMAs were followed by messages that focused on planning and preparing for the quit attempt. During the postcessation period, participant responses to EMAs drove an algorithm that tailored messages to the current level of smoking lapse risk and currently present lapse triggers (eg, urge to smoke, stress). Smart-T offered additional intervention features on demand (eg, one-click access to the tobacco cessation quitline; "Quit Tips" on coping with urges to smoke, mood, and stress). Participants (N=59) were 52.0 (SD 7.0) years old, 54% (32/59) female, and 53% (31/59) African American, and 70% (40/57) had annual household income less than US $16,000. Participants smoked 20.3 (SD 11.6) cigarettes per day and had been smoking for 31.6 (SD 10.9) years. Twelve weeks after the scheduled quit date, 20% (12/59) of all participants were biochemically confirmed abstinent. Participants responded to 87% of all prompted EMAs and received approximately 102 treatment messages over the 3-week EMA period. Most participants (83%, 49/59) used the on-demand app features. Individuals with greater nicotine dependence and minority race used the Quit Tips feature more than their counterparts. Greater use of the Quit Tips feature was linked to nonabstinence at the 2 (P=.02), 4 (P<.01), and 12 (P=.03) week follow-up visits. Most participants reported that they actually used or implemented the tailored app-generated messages and suggestions (83%, 49/59); the app-generated messages were helpful (97%, 57/59); they would like to use the app in the future if they were to lapse (97%, 57/59); and they would like to refer friends who smoke to use the Smart-T app (85%, 50/59). A minority of participants (15%, 9/59) reported that the number of daily assessments (ie, 5) was "too high." This novel just-in-time adaptive intervention delivered an intensive intervention (ie, 102 messages over a 3-week period), was well-liked, and was perceived as helpful and useful by socioeconomically disadvantaged adults who were seeking smoking cessation treatment. Smartphone apps may be used to increase treatment exposure and may ultimately reduce tobacco-related health disparities among socioeconomically disadvantaged adults. ©Michael S Businelle, Ping Ma, Darla E Kendzor, Summer G Frank, Damon J Vidrine, David W Wetter. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 12.12.2016.

Ocular medicines in children: the regulatory situation related to clinical research

PubMed Central

2012-01-01

Background Many ocular medications are prescribed for paediatric patients, but the evidence for their rational use is very scant. This study was planned to compare the availability and the licensing status of ocular medications marketed in Italy, the United Kingdom (UK), and the United States of America (USA) related to the amount of published and un-published RCTs testing these drugs in the paediatric population. Methods A quantitative analysis was performed to evaluate the number of ocular medications with a paediatric license in Italy, the UK, and the USA. A literature search was also performed in MEDLINE, EMBASE, and The Cochrane Central Register of Controlled Trials for randomized controlled trials (RCTs) on ophthalmic pharmacological therapy in children aged < 18 years, published up to December 2010. A search in the international clinical trial registries, the list of paediatric investigation plans (PIPs) approved by European Medicines Agency (EMA), and the table of medicines with new paediatric information approved by Food and Drug Administration (FDA) was also performed. Results In all, of 197 drugs identified, 68 (35%) single drugs are licensed for paediatric use at least in one considered country, while 23 (12%) were marketed in all three countries. More specifically, in Italy 43 single drugs (48% of those marketed) had a paediatric license, while 39 (64%) did in the UK and 22 (54%) did in the USA. Only 13 drugs were marketed with a paediatric license in all countries. The percentage of drugs licensed for paediatric use and for which at least one RCT had been performed ranged between 51% in Italy and 55% in the USA. No published RCTs were found for 11 (48%) drugs licensed for paediatric use in all three countries. In all, 74 (35%) of the retrieved RCTs involved mydriatic/cycloplegic medications. A total of 62 RCTs (56% completed) on 46 drugs were found in the international clinical trial registries. Cyclosporin and bevacizumab were being studied in many ongoing trials. Twenty-six drugs had new paediatric information approved by FDA based on new paediatric clinical trials, while only 4 PIPs were approved by EMA. Conclusions There is a pressing need for further research and clinical development in the pediatric ophthalmic area, where effective up-to-date treatments, and additional research and education on use in children, remain priorities. PMID:22264311

44 CFR 302.6 - Fiscal year limitation.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 44 Emergency Management and Assistance 1 2010-10-01 2010-10-01 false Fiscal year limitation. 302.6 Section 302.6 Emergency Management and Assistance FEDERAL EMERGENCY MANAGEMENT AGENCY, DEPARTMENT OF HOMELAND SECURITY PREPAREDNESS CIVIL DEFENSE-STATE AND LOCAL EMERGENCY MANAGEMENT ASSISTANCE PROGRAM (EMA...

44 CFR 302.6 - Fiscal year limitation.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 44 Emergency Management and Assistance 1 2013-10-01 2013-10-01 false Fiscal year limitation. 302.6 Section 302.6 Emergency Management and Assistance FEDERAL EMERGENCY MANAGEMENT AGENCY, DEPARTMENT OF HOMELAND SECURITY PREPAREDNESS CIVIL DEFENSE-STATE AND LOCAL EMERGENCY MANAGEMENT ASSISTANCE PROGRAM (EMA...

44 CFR 302.6 - Fiscal year limitation.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 44 Emergency Management and Assistance 1 2012-10-01 2011-10-01 true Fiscal year limitation. 302.6 Section 302.6 Emergency Management and Assistance FEDERAL EMERGENCY MANAGEMENT AGENCY, DEPARTMENT OF HOMELAND SECURITY PREPAREDNESS CIVIL DEFENSE-STATE AND LOCAL EMERGENCY MANAGEMENT ASSISTANCE PROGRAM (EMA...

44 CFR 302.1 - Purpose.

Code of Federal Regulations, 2012 CFR

2012-10-01

... Emergency Management and Assistance FEDERAL EMERGENCY MANAGEMENT AGENCY, DEPARTMENT OF HOMELAND SECURITY PREPAREDNESS CIVIL DEFENSE-STATE AND LOCAL EMERGENCY MANAGEMENT ASSISTANCE PROGRAM (EMA) § 302.1 Purpose. (a... political subdivisions, for up to one half of the necessary and essential State and local civil defense...

44 CFR 302.6 - Fiscal year limitation.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 44 Emergency Management and Assistance 1 2014-10-01 2014-10-01 false Fiscal year limitation. 302.6 Section 302.6 Emergency Management and Assistance FEDERAL EMERGENCY MANAGEMENT AGENCY, DEPARTMENT OF HOMELAND SECURITY PREPAREDNESS CIVIL DEFENSE-STATE AND LOCAL EMERGENCY MANAGEMENT ASSISTANCE PROGRAM (EMA...

44 CFR 302.1 - Purpose.

Code of Federal Regulations, 2013 CFR

2013-10-01

... Emergency Management and Assistance FEDERAL EMERGENCY MANAGEMENT AGENCY, DEPARTMENT OF HOMELAND SECURITY PREPAREDNESS CIVIL DEFENSE-STATE AND LOCAL EMERGENCY MANAGEMENT ASSISTANCE PROGRAM (EMA) § 302.1 Purpose. (a... political subdivisions, for up to one half of the necessary and essential State and local civil defense...

44 CFR 302.1 - Purpose.

Code of Federal Regulations, 2014 CFR

2014-10-01

... Emergency Management and Assistance FEDERAL EMERGENCY MANAGEMENT AGENCY, DEPARTMENT OF HOMELAND SECURITY PREPAREDNESS CIVIL DEFENSE-STATE AND LOCAL EMERGENCY MANAGEMENT ASSISTANCE PROGRAM (EMA) § 302.1 Purpose. (a... political subdivisions, for up to one half of the necessary and essential State and local civil defense...

44 CFR 302.6 - Fiscal year limitation.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 44 Emergency Management and Assistance 1 2011-10-01 2011-10-01 false Fiscal year limitation. 302.6 Section 302.6 Emergency Management and Assistance FEDERAL EMERGENCY MANAGEMENT AGENCY, DEPARTMENT OF HOMELAND SECURITY PREPAREDNESS CIVIL DEFENSE-STATE AND LOCAL EMERGENCY MANAGEMENT ASSISTANCE PROGRAM (EMA...

44 CFR 302.1 - Purpose.

Code of Federal Regulations, 2011 CFR

2011-10-01

... Emergency Management and Assistance FEDERAL EMERGENCY MANAGEMENT AGENCY, DEPARTMENT OF HOMELAND SECURITY PREPAREDNESS CIVIL DEFENSE-STATE AND LOCAL EMERGENCY MANAGEMENT ASSISTANCE PROGRAM (EMA) § 302.1 Purpose. (a... political subdivisions, for up to one half of the necessary and essential State and local civil defense...

Celiac Disease Testing (for Health Care Professionals)

MedlinePlus

... diet. tTG The tTG-IgA test is an enzyme-linked immunosorbent assay (ELISA) test. The tTG-IgA test is the preferred ... a more expensive and time-consuming process than ELISA testing. In addition, the EMA test is qualitative, ...