Studying the effects of classic hallucinogens in the treatment of alcoholism: rationale, methodology, and current research with psilocybin.

Science.gov (United States)

Bogenschutz, Michael P

2013-03-01

Recent developments in the study of classic hallucinogens, combined with a re-appraisal of the older literature, have led to a renewal of interest in possible therapeutic applications for these drugs, notably their application in the treatment of addictions. This article will first provide a brief review of the research literature providing direct and indirect support for the possible therapeutic effects of classic hallucinogens such as psilocybin and lysergic acid diethylamide (LSD) in the treatment of addictions. Having provided a rationale for clinical investigation in this area, we discuss design issues in clinical trials using classic hallucinogens, some of which are unique to this class of drug. We then discuss the current status of this field of research and design considerations in future randomized trials.

Effects of Role and Assignment Rationale on Attitudes Formed During Peer Tutoring

Science.gov (United States)

Bierman, Karen Linn; Furman, Wyndol

2012-01-01

This study examined the role of contextual factors, such as assignment rationale, on the attitudinal effects of peer tutoring. Fourth-grade children engaged in brief tutoring experiences as either a tutor or tutee. Subjects received four rationales for being selected as tutor or tutee: (a) a competence rationale, (b) a physical characteristic rationale, (c) a chance rationale, or (d) no rationale. As predicted, tutors had more positive attitudes than tutees when they had been given a competence or physical characteristic rationale but not when the tutors were provided a chance rationale or no rationale. Additionally, the tutors’ and tutees’ attitudes were enhanced when no rationale was provided. Results are discussed in terms of their implications for a role-theory analysis of tutoring and their implications for applied programs. PMID:23946549

Design and rationale for examining neuroimaging genetics in ischemic stroke: The MRI-GENIE study.

Science.gov (United States)

Giese, Anne-Katrin; Schirmer, Markus D; Donahue, Kathleen L; Cloonan, Lisa; Irie, Robert; Winzeck, Stefan; Bouts, Mark J R J; McIntosh, Elissa C; Mocking, Steven J; Dalca, Adrian V; Sridharan, Ramesh; Xu, Huichun; Frid, Petrea; Giralt-Steinhauer, Eva; Holmegaard, Lukas; Roquer, Jaume; Wasselius, Johan; Cole, John W; McArdle, Patrick F; Broderick, Joseph P; Jimenez-Conde, Jordi; Jern, Christina; Kissela, Brett M; Kleindorfer, Dawn O; Lemmens, Robin; Lindgren, Arne; Meschia, James F; Rundek, Tatjana; Sacco, Ralph L; Schmidt, Reinhold; Sharma, Pankaj; Slowik, Agnieszka; Thijs, Vincent; Woo, Daniel; Worrall, Bradford B; Kittner, Steven J; Mitchell, Braxton D; Rosand, Jonathan; Golland, Polina; Wu, Ona; Rost, Natalia S

2017-10-01

To describe the design and rationale for the genetic analysis of acute and chronic cerebrovascular neuroimaging phenotypes detected on clinical MRI in patients with acute ischemic stroke (AIS) within the scope of the MRI-GENetics Interface Exploration (MRI-GENIE) study. MRI-GENIE capitalizes on the existing infrastructure of the Stroke Genetics Network (SiGN). In total, 12 international SiGN sites contributed MRIs of 3,301 patients with AIS. Detailed clinical phenotyping with the web-based Causative Classification of Stroke (CCS) system and genome-wide genotyping data were available for all participants. Neuroimaging analyses include the manual and automated assessments of established MRI markers. A high-throughput MRI analysis pipeline for the automated assessment of cerebrovascular lesions on clinical scans will be developed in a subset of scans for both acute and chronic lesions, validated against gold standard, and applied to all available scans. The extracted neuroimaging phenotypes will improve characterization of acute and chronic cerebrovascular lesions in ischemic stroke, including CCS subtypes, and their effect on functional outcomes after stroke. Moreover, genetic testing will uncover variants associated with acute and chronic MRI manifestations of cerebrovascular disease. The MRI-GENIE study aims to develop, validate, and distribute the MRI analysis platform for scans acquired as part of clinical care for patients with AIS, which will lead to (1) novel genetic discoveries in ischemic stroke, (2) strategies for personalized stroke risk assessment, and (3) personalized stroke outcome assessment.

Efficacy, safety and tolerability of simvastatin in children with familial hypercholesterolaemia - Rationale, design and baseline characteristics

NARCIS (Netherlands)

de Jongh, S.; Stalenhoef, A. F. H.; Tuohy, M. B.; Mercuri, M.; Bakker, H. D.; Kastelein, J. J. P.

2002-01-01

Objective: To describe the rationale, design and baseline data of a study conducted to determine the efficacy, safety and tolerability of simvastatin in children and adolescents with heterozygous familial hypercholesterolaemia (heFH). Methods: Patients were recruited from nine lipid clinics

Rationales for Commonly "Challenged" Taught Books.

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Shugert, Diane P., Ed.; And Others

1983-01-01

Intended for teachers, this focused journal issue contains separate rationales for teaching books that have been challenged as appropriate instructional materials. Following a discussion of the purpose for rationales and suggestions for using them, the journal presents rationales for teaching the following books: "To Kill a Mockingbird,""The Diary…

Rationale and Design of the Echocardiographic Study of Hispanics/Latinos (ECHO-SOL).

Science.gov (United States)

Rodriguez, Carlos J; Dharod, Ajay; Allison, Matthew A; Shah, Sanjiv J; Hurwitz, Barry; Bangdiwala, Shrikant I; Gonzalez, Franklyn; Kitzman, Dalane; Gillam, Linda; Spevack, Daniel; Dadhania, Rupal; Langdon, Sarah; Kaplan, Robert

2015-01-01

Information regarding the prevalence and determinants of cardiac structure and function (systolic and diastolic) among the various Hispanic background groups in the United States is limited. The Echocardiographic Study of Latinos (ECHO-SOL) ancillary study recruited 1,824 participants through a stratified-sampling process representative of the population-based Hispanic Communities Health Study - Study of Latinos (HCHS-SOL) across four sites (Bronx, NY; Chicago, Ill; San Diego, Calif; Miami, Fla). The HCHS-SOL baseline cohort did not include an echo exam. ECHO-SOL added the echocardiographic assessment of cardiac structure and function to an array of existing HCHS-SOL baseline clinical, psychosocial, and socioeconomic data and provides sufficient statistical power for comparisons among the Hispanic subgroups. Standard two-dimensional (2D) echocardiography protocol, including M-mode, spectral, color and tissue Doppler study was performed. The main objectives were to: 1) characterize cardiac structure and function and its determinants among Hispanics and Hispanic subgroups; and 2) determine the contributions of specific psychosocial factors (acculturation and familismo) to cardiac structure and function among Hispanics. We describe the design, methods and rationale of currently the largest and most comprehensive study of cardiac structure and function exclusively among US Hispanics. ECHO-SOL aims to enhance our understanding of Hispanic cardiovascular health as well as help untangle the relative importance of Hispanic subgroup heterogeneity and sociocultural factors on cardiac structure and function.

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

Science.gov (United States)

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

2017-10-01

Potential research participants may assume that randomized trials comparing new interventions with older interventions always hypothesize greater efficacy for the new intervention, as in superiority trials. However, antibiotic trials frequently use "noninferiority" hypotheses allowing a degree of inferior efficacy deemed "clinically acceptable" compared with an older effective drug, in exchange for nonefficacy benefits (eg, decreased adverse effects). Considering these different benefit-harm trade-offs, proper informed consent necessitates supplying different information on the purposes of superiority and noninferiority trials. To determine the degree to which the study purpose is explained to potential participants in randomized clinical trials of antibiotics and the degree to which study protocols justify their selection of noninferiority hypotheses and amount of "clinically acceptable" inferiority. Cross-sectional analysis of study protocols, statistical analysis plans (SAPs), and informed consent forms (ICFs) from clinical study reports submitted to the European Medicines Agency. The ICFs were read by both methodologists and patient investigators. Protocols and SAPs were used as the reference standard to determine prespecified primary hypothesis and record rationale for selection of noninferiority hypotheses and noninferiority margins. This information was cross-referenced against ICFs to determine whether ICFs explained the study purpose. We obtained trial documents from 78 randomized trials with prespecified efficacy hypotheses (6 superiority, 72 noninferiority) for 17 antibiotics conducted between 1991 and 2011 that enrolled 39 407 patients. Fifty were included in the ICF analysis. All ICFs contained sections describing study purpose; however, none consistently conveyed study hypothesis to both methodologists and patient investigators. Methodologists found that 1 of 50 conveyed a study purpose. Patient investigators found that 11 of 50 conveyed a study

Rationale and design of a pilot study examining Acceptance and Commitment Therapy for persistent pain in an integrated primary care clinic.

Science.gov (United States)

Kanzler, Kathryn E; Robinson, Patricia J; McGeary, Donald D; Mintz, Jim; Potter, Jennifer Sharpe; Muñante, Mariana; Lopez, Eliot J; Dougherty, Donald M; Hale, Willie J; Velligan, Dawn I

2018-03-01

Most of the 100 million Americans with persistent pain are treated in primary care clinics, but evidence-based psychosocial approaches targeting pain-related disability are not usually provided in these settings. This manuscript describes the rationale and methods for a protocol to pilot test the feasibility and effectiveness of Acceptance and Commitment Therapy (ACT), an evidence-based psychological treatment for persistent pain, delivered by a Behavioral Health Consultant in primary care. Eligible patients are identified through electronic health record registries and invited to participate via secure messaging, letters and a follow-up phone call. Participants are also recruited with advertising and clinician referral. Patients agreeing to participate are consented and complete initial assessments, with a target of 60 participants. Randomization is stratified based on pain severity with participants assigned to either ACT or Enhanced Treatment as Usual (E-TAU). ACT participants receive one standardized Behavioral Health Consultation visit followed by three ACT-based group visits and one group booster visit. All patients attend six assessment visits, during which the E-TAU patients are provided with educational pain management handouts based on standard cognitive behavioral treatment of pain. The study aims to determine feasibility and effectiveness of brief ACT for persistent pain delivered by an integrated behavioral health clinician in primary care from pre- to post-treatment, and to examine mechanisms of change in ACT participants. This study, in a "real-world" setting, will lay groundwork for a larger trial. If effective, it could improve treatment methods and quality of life for patients with persistent pain using a scalable approach. Copyright © 2018 Elsevier Inc. All rights reserved.

The design, rationale, and baseline characteristics of a nationwide cohort registry in China: blood pressure and clinical outcome in TIA or ischemic stroke.

Science.gov (United States)

Xu, Jie; Liu, Yi; Tao, Yongli; Xie, Xuewei; Gu, Hongqiu; Pan, Yuesong; Zhao, Xingquan; Wang, Yongjun; Yan, Aoshuang; Wang, Yilong

2016-01-01

The relationship between poststroke blood pressure (BP) and clinical outcomes in ischemic stroke (IS) is still controversial. However, there is no large BP database for IS or transient ischemic attack (TIA) in China. This study aims to describe the rationale, study design, and baseline characteristics of a nationwide BP database in IS or TIA patients in China. The BOSS (blood pressure and clinical outcome in TIA or ischemic stroke) study was a hospital-based, prospective cohort study aiming to assess BP parameters and clinical outcome in IS/TIA patients. BP parameters were based on office BP, ambulatory BP, and home BP. Clinical outcomes included stroke recurrence, combined vascular events, and disability. Electronic case-report forms were used to record baseline and follow-up data. The patients were followed up for clinical outcomes at 3 months through face-to-face interview and at 12 months by telephone. Between October 2012 and February 2014, the BOSS registry recruited 2,608 patients from 61 hospitals, with a mean age of 62.5 years, 32.4% of whom were female, 88.9% with an entry diagnosis of IS, and 86% diagnosed with hypertension. The rates of patients lost-to-follow-up were 3.1% at 3 months and 5.1% at 1 year; 93% of patients completed ambulatory BP monitoring during hospitalization and 94.7% finished a 3-month BP diary. The BOSS registry will provide important evidence about BP management in the acute phase and secondary prevention for IS/TIA patients.

Child/Adolescent Anxiety Multimodal Study (CAMS: rationale, design, and methods

Directory of Open Access Journals (Sweden)

Waslick Bruce D

2010-01-01

Full Text Available Abstract Objective To present the design, methods, and rationale of the Child/Adolescent Anxiety Multimodal Study (CAMS, a recently completed federally-funded, multi-site, randomized placebo-controlled trial that examined the relative efficacy of cognitive-behavior therapy (CBT, sertraline (SRT, and their combination (COMB against pill placebo (PBO for the treatment of separation anxiety disorder (SAD, generalized anxiety disorder (GAD and social phobia (SoP in children and adolescents. Methods Following a brief review of the acute outcomes of the CAMS trial, as well as the psychosocial and pharmacologic treatment literature for pediatric anxiety disorders, the design and methods of the CAMS trial are described. Results CAMS was a six-year, six-site, randomized controlled trial. Four hundred eighty-eight (N = 488 children and adolescents (ages 7-17 years with DSM-IV-TR diagnoses of SAD, GAD, or SoP were randomly assigned to one of four treatment conditions: CBT, SRT, COMB, or PBO. Assessments of anxiety symptoms, safety, and functional outcomes, as well as putative mediators and moderators of treatment response were completed in a multi-measure, multi-informant fashion. Manual-based therapies, trained clinicians and independent evaluators were used to ensure treatment and assessment fidelity. A multi-layered administrative structure with representation from all sites facilitated cross-site coordination of the entire trial, study protocols and quality assurance. Conclusions CAMS offers a model for clinical trials methods applicable to psychosocial and psychopharmacological comparative treatment trials by using state-of-the-art methods and rigorous cross-site quality controls. CAMS also provided a large-scale examination of the relative and combined efficacy and safety of the best evidenced-based psychosocial (CBT and pharmacologic (SSRI treatments to date for the most commonly occurring pediatric anxiety disorders. Primary and secondary results

A review and rationale for studying the cardiovascular effects of drinking water arsenic in women of reproductive age

International Nuclear Information System (INIS)

Kwok, Richard K.

2007-01-01

Drinking water arsenic has been shown to be associated with a host of adverse health outcomes at exposure levels > 300 μg of As/L. However, the results are not consistent at exposures below this level. We have reviewed selected articles that examine the effects of drinking water arsenic on cardiovascular outcomes and present a rationale for studying these effects on women of reproductive age, and also over the course of pregnancy when they would potentially be more susceptible to adverse cardiovascular and reproductive outcomes. It is only recently that reproductive effects have been linked to drinking water arsenic. However, there is a paucity of information about the cardiovascular effects of drinking water arsenic on women of reproductive age. Under the cardiovascular challenge of pregnancy, we hypothesize that women with a slightly elevated exposure to drinking water arsenic may exhibit adverse cardiovascular outcomes at higher rates than in the general population. Studying sensitive clinical and sub-clinical indicators of disease in susceptible sub-populations may yield important information about the potentially enormous burden of disease related to low-level drinking water arsenic exposure

The rationale for use of Ulipristal Acetate as first line in emergency contraception: biological and clinical evidence.

Science.gov (United States)

Glasier, Anna

2014-10-01

Ulipristal acetate (UPA) was licensed as an emergency contraceptive (EC) in Europe in 2009. By the end of May 2013, over 1.4 million courses had been used. The rationale for using UPA for EC in favor of the much more commonly used levonorgestrel (LNG) is based on data on efficacy, safety and side effects. In two large clinical trials among women presenting for EC up to 120 hours after unprotected sex, UPA was as effective as LNG at preventing pregnancy. When the two trials were combined in a meta analysis UPA was superior, almost halving the risk of pregnancy compared with LNG. Biomedical studies have shown that UPA inhibits or delays ovulation more effectively than LNG at a stage of the cycle when the risk of pregnancy is highest. Safety and side effects: UPA and LNG have similar side effect profiles and to date no serious adverse events have been attributed to use of UPA for EC. Data on pregnancies conceived in association with UPA use are reassuring. There is no evidence for teratogenesis or for any increased risk of ectopic pregnancy or miscarriage. Use of UPA will remain limited until it is available without a doctor's prescription.

Capturing microscopic features of bone remodeling into a macroscopic model based on biological rationales of bone adaptation.

Science.gov (United States)

Kim, Young Kwan; Kameo, Yoshitaka; Tanaka, Sakae; Adachi, Taiji

2017-10-01

To understand Wolff's law, bone adaptation by remodeling at the cellular and tissue levels has been discussed extensively through experimental and simulation studies. For the clinical application of a bone remodeling simulation, it is significant to establish a macroscopic model that incorporates clarified microscopic mechanisms. In this study, we proposed novel macroscopic models based on the microscopic mechanism of osteocytic mechanosensing, in which the flow of fluid in the lacuno-canalicular porosity generated by fluid pressure gradients plays an important role, and theoretically evaluated the proposed models, taking biological rationales of bone adaptation into account. The proposed models were categorized into two groups according to whether the remodeling equilibrium state was defined globally or locally, i.e., the global or local uniformity models. Each remodeling stimulus in the proposed models was quantitatively evaluated through image-based finite element analyses of a swine cancellous bone, according to two introduced criteria associated with the trabecular volume and orientation at remodeling equilibrium based on biological rationales. The evaluation suggested that nonuniformity of the mean stress gradient in the local uniformity model, one of the proposed stimuli, has high validity. Furthermore, the adaptive potential of each stimulus was discussed based on spatial distribution of a remodeling stimulus on the trabecular surface. The theoretical consideration of a remodeling stimulus based on biological rationales of bone adaptation would contribute to the establishment of a clinically applicable and reliable simulation model of bone remodeling.

Apixaban for the Secondary Prevention of Thrombosis Among Patients With Antiphospholipid Syndrome: Study Rationale and Design (ASTRO-APS).

Science.gov (United States)

Woller, Scott C; Stevens, Scott M; Kaplan, David A; Branch, D Ware; Aston, Valerie T; Wilson, Emily L; Gallo, Heather M; Johnson, Eric G; Rondina, Matthew T; Lloyd, James F; Evans, R Scott; Elliott, C Gregory

2016-04-01

Antiphospholipid syndrome (APS) is an acquired thrombophilia characterized by thrombosis, pregnancy morbidity, and the presence of characteristic antibodies. Current therapy for patients having APS with a history of thrombosis necessitates anticoagulation with the vitamin K antagonist warfarin, a challenging drug to manage. Apixaban, approved for the treatment and prevention of venous thrombosis with a low rate of bleeding observed, has never been studied among patients with APS. We report study rationale and design of Apixaban for the Secondary Prevention of Thrombosis Among Patients With Antiphospholipid Syndrome (ASTRO-APS), a prospective randomized open-label blinded event pilot study that will randomize patients with a clinical diagnosis of APS receiving therapeutic anticoagulation to either adjusted-dose warfarin or apixaban 2.5 mg twice a day. We aim to report our ability to identify, recruit, randomize, and retain patients with APS randomized to apixaban compared with warfarin. We will report clinically important outcomes of thrombosis and bleeding. All clinical outcomes will be adjudicated by a panel blinded to the treatment arm. A unique aspect of this study is the enrollment of patients with an established clinical diagnosis of APS. Also unique is our use of electronic medical record interrogation techniques to identify patients who would likely meet our inclusion criteria and use of an electronic portal for follow-up visit data capture. ASTRO-APS will be the largest prospective study to date comparing a direct oral anticoagulant with warfarin among patients with APS for the secondary prevention of thrombosis. Our inclusion criteria assure that outcomes obtained will be clinically applicable to the routine management of patients with APS receiving indefinite anticoagulation. © The Author(s) 2015.

Collaborative Behavioral Management for Drug-Involved Parolees: Rationale and Design of the Step'n Out Study

Science.gov (United States)

Friedmann, Peter D.; Katz, Elizabeth C.; Rhodes, Anne G.; Taxman, Faye S.; O'Connell, Daniel J.; Frisman, Linda K.; Burdon, William M.; Fletcher, Bennett W.; Litt, Mark D.; Clarke, Jennifer; Martin, Steven S.

2008-01-01

This article describes the rationale, study design, and implementation for the Step'n Out study of the Criminal Justice Drug Abuse Treatment Studies. Step'n Out tests the relative effectiveness of collaborative behavioral management of drug-involved parolees. Collaborative behavioral management integrates the roles of parole officers and treatment…

CORONARY DIET INTERVENTION WITH OLIVE OIL AND CARDIOVASCULAR PREVENTION STUDY (THE CORDIOPREV STUDY): RATIONALE, METHODS, AND BASELINE CHARACTERISTICS

Science.gov (United States)

Delgado-Lista, Javier; Perez-Martinez, Pablo; Garcia-Rios, Antonio; Alcala-Diaz, Juan F; Perez-Caballero, Ana I.; Gomez-Delgado, Francisco; Fuentes, Francisco; Quintana-Navarro, Gracia; Lopez-Segura, Fernando; Ortiz-Morales, Ana M; Delgado-Casado, Nieves; Yubero-Serrano, Elena; Camargo, Antonio; Marin, Carmen; Rodriguez-Cantalejo, Fernando; Gomez-Luna, Purificacion; Ordovas, Jose M; Lopez-Miranda, Jose; Perez-Jimenez, Francisco

2016-01-01

Coronary heart disease (CHD) represents a major global health burden. However, despite the well-known influence that dietary habits exert over the progression of this disease, there are no well-established and scientifically sound dietary approaches to prevent the onset of clinical outcomes in secondary prevention. The objective of the CORonary Diet Intervention with Olive oil and cardiovascular PREVention study (CORDIOPREV study, clinical trials number NCT00924937) is to compare the ability of a Mediterranean diet rich in virgin olive oil versus a low-fat diet to influence the composite incidence of cardiovascular events after 7 years, in subjects with documented CHD at baseline. For this purpose, we enrolled 1002 coronary patients from Spain. Baseline assessment (2009–12) included detailed interviews and measurements to assess dietary, social and biological variables. Results of baseline characteristics: The CORDIOPREV study in Spain describes a population with a high BMI (37.2% overweight and 56.3% obesity), with a median of LDL-cholesterol of 88.5 mg/dL (70.6% of the patients having <100 mg/dL, and 20.3% patients < 70 mg/dL). 9.6% of the participants were active smokers, and 64.4% were former smokers. Metabolic Syndrome was present in 58% of this population. To sum up, we describe here the rationale, methods and baseline characteristics of the CORDIOPREV study, which will test for the first time the efficacy of a Mediterranean Diet rich in extra virgin olive oil as compared with a low-fat diet on the incidence of CHD recurrence in a long term follow-up study. PMID:27297848

Evaluation oF FactORs ImpacTing CLinical Outcome and Cost EffectiveneSS of the S-ICD: Design and Rationale of the EFFORTLESS S-ICD Registry

DEFF Research Database (Denmark)

Pedersen, Susanne S; Lambiase, Pier; Boersma, Lucas V A

2012-01-01

utilization. Methods: The Registry is an observational, nonrandomized, standard of care evaluation to be conducted at approximately 50 investigational centers in Europe and New Zealand where the S-ICD is approved for use and distribution. Clinical Registry endpoints include perioperative (30 days postimplant......Background: Leads in and on the heart of the transvenous implantable cardioverter defibrillator (ICD) form the Achilles' heel of this system due to potential for peri- and postimplant complications. The S-ICD is a newer generation of the ICD that does not require leads on the heart...... or in the vasculature. We present the rationale and study design of the Evaluation oF FactORs ImpacTing CLinical Outcome and Cost EffectiveneSS of the S-ICD (EFFORTLESS S-ICD) Registry which was designed to evaluate the long-term performance of the S-ICD including patient quality of life and long-term resource...

When Regional Innovation Policies Meet Policy Rationales and Evidence:

DEFF Research Database (Denmark)

Borrás, Susana; Jordana, Jacint

regions, and to understand how rationales and evidence can be translated into policy-making. To this purpose, this paper develops a framework to study the extent to which regional innovation policies have changed during the past few years. Since the mid-2000s there has been an important development......In spite of recent advancements regarding regional innovation policy rationales and evidence, there are few analyses about the actual features of existing regional innovation policies. Nevertheless, a policy analysis perspective is important in order to recognise their distinctive patterns across...... of innovation policy rationales, advocating for more specialisation; likewise, greater data availability at the regional level has allowed more sophisticated assessment of innovation performance. Finally, the crisis since 2008 has had ravaging effects in some regions, with job losses and severe economic...

When Regional Innovation Policies Meet Policy Rationales and Evidence

DEFF Research Database (Denmark)

Borrás, Susana; Jordana, Jacint

2016-01-01

regions, and to understand how rationales and evidence can be translated into policy-making. To this purpose, this paper develops a framework to study the extent to which regional innovation policies have changed during the past few years. Since the mid-2000s, there has been an important development......In spite of recent advancements regarding regional innovation policy rationales and evidence, there are few analyses about the actual features of existing regional innovation policies. Nevertheless, a policy analysis perspective is important in order to recognize their distinctive patterns across...... of innovation policy rationales, advocating for more specialization; likewise, greater data availability at the regional level has allowed more sophisticated assessment of innovation performance. Finally, the crisis since 2008 has had ravaging effects in some regions, with job losses and severe economic...

Rationale and methods of the EFCOSUM project

NARCIS (Netherlands)

Brussaard, J.H.; Johansson, L.; Kearney, J.

2002-01-01

Objective: To describe the rationale and methods for a European project (EFCOSUM) to develop a method for a European food consumption survey that delivers internationally comparable data on a set of policy-relevant nutritional indicators. Rationale and methods: Currently Member States are collecting

Theoretical rationale for music selection in oncology intervention research: an integrative review.

Science.gov (United States)

Burns, Debra S

2012-01-01

Music-based interventions have helped patients with cancer improve their quality of life, decrease treatment related distress, and manage pain. However, quantitative findings from music intervention studies are inconsistent. The purpose of this review was to explore the theoretical underpinnings for the selection of the music stimuli used to influence targeted outcomes. It was hypothesized that disparate findings were due in part to the atheoretical nature of music selection and the resulting diversity in music stimuli between and within studies. A systematic research synthesis including a comprehensive database and reference list search resulted in 22 studies. Included studies were compiled into two tables cataloging intervention theory, intervention content, and outcomes. A majority of studies did not provide a rationale or intervention theory for the delivery of music or choice of outcomes. Recorded music was the most common delivery method, but the specific music was rarely included within the report. Only two studies that included a theoretical framework reported null results on at least some of the outcomes. Null results are partially explained by an incomplete or mismatch in intervention theory and music selection and delivery. While the inclusion of an intervention theory does not guarantee positive results, including a theoretical rationale for the use of music, particular therapeutic processes or mechanisms, and the specifics of how music is selected and delivered increases scientific rigor and the probability of clinical translation.

Using Rationale To Assist Student Cognitive And Intellectual Development

Directory of Open Access Journals (Sweden)

Janet E. Burge

2010-01-01

Full Text Available One of the questions posed at the National Science Foundation (NSF-sponsored workshop on Creativity and Rationale in Software Design was on the role of rationale in supporting idea generation in the classroom. College students often struggle with problems where more than one possible solution exists. Part of the difficulty lies in the need for students to progress through different levels of development cognitively and intellectually before they can tackle creative problem solving. Argumentation-based rationale provides a natural mechanism for representing problems, candidate solutions, criteria, and arguments relating those criteria to the candidate solutions. Explicitly expressing rationale for their work encourages students to reflect on why they made their choices, and to actively consider multiple alternatives. We report on an experiment performed during a Data Structures course where students captured rationale.

The "BIOmarkers associated with Sarcopenia and PHysical frailty in EldeRly pErsons" (BIOSPHERE) study: Rationale, design and methods.

Science.gov (United States)

Calvani, Riccardo; Picca, Anna; Marini, Federico; Biancolillo, Alessandra; Cesari, Matteo; Pesce, Vito; Lezza, Angela Maria Serena; Bossola, Maurizio; Leeuwenburgh, Christiaan; Bernabei, Roberto; Landi, Francesco; Marzetti, Emanuele

2018-05-10

Sarcopenia, the progressive and generalised loss of muscle mass and strength/function, is a major health issue in older adults given its high prevalence and burdensome clinical implications. Over the years, this condition has been endorsed as a marker for discriminating biological from chronological age. However, the absence of a unified operational definition has hampered its full appreciation by healthcare providers, researchers and policy-makers. In addition to this unsolved debate, the complexity of musculoskeletal ageing represents a major challenge to the identification of clinically meaningful biomarkers. Here, we illustrate the advantages of biomarker discovery procedures in muscle ageing based on multivariate methodologies as an alternative approach to traditional single-marker strategies. The rationale, design and methods of the "BIOmarkers associated with Sarcopenia and PHysical frailty in EldeRly pErsons" (BIOSPHERE) study are described as an application of a multi-marker strategy for the development of biomarkers for the newly operationalised Physical Frailty & Sarcopenia condition. Copyright © 2018 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.

Evaluating web-based cognitive-affective remediation in recent trauma survivors: study rationale and protocol.

Science.gov (United States)

Fine, Naomi B; Achituv, Michal; Etkin, Amit; Merin, Ofer; Shalev, Arieh Y

2018-01-01

Background : The immediate aftermath of traumatic events is a period of enhanced neural plasticity, following which some survivors remain with post-traumatic stress disorder (PTSD) whereas others recover. Evidence points to impairments in emotional reactivity, emotion regulation, and broader executive functions as critically contributing to PTSD. Emerging evidence further suggests that the neural mechanisms underlying these functions remain plastic in adulthood and that targeted retraining of these systems may enhance their efficiency and could reduce the likelihood of developing PTSD. Administering targeted neurocognitive training shortly after trauma exposure is a daunting challenge. This work describes a study design addressing that challenge. The study evaluated the direct effects of cognitive remediation training on neurocognitive mechanisms that hypothetically underlay PTSD, and the indirect effect of this intervention on emerging PTSD symptoms. Method : We describe a study rationale, design, and methodological choices involving: (a) participants' enrolment; (b) implementation and management of a daily self-administered, web-based intervention; (c) reliable, timely screening and assessment of treatment of eligible survivors; and (d) defining control conditions and outcome measures. We outline the rationale of choices made regarding study sample, timing of intervention, measurements, monitoring participants' adherence, and ways to harmonize and retain interviewers' fidelity and mitigate eventual burnout by repeated contacts with recently traumatized survivors. Conclusion : Early web-based interventions targeting causative mechanisms of PTSD can be informed by the model presented in this paper.

Narrative reconstruction therapy for prolonged grief disorder—rationale and case study

Directory of Open Access Journals (Sweden)

Tuvia Peri

2016-05-01

Full Text Available Background: Prolonged grief disorder (PGD is a potentially disabling condition affecting approximately 10% of bereaved people. It has been suggested that the impaired integration of the loss memory, as expressed in recurrent memories of the loss and disorganization of memory, is involved in the development of PGD. Narrative reconstruction (NR, originally designed for the treatment of posttraumatic stress disorder (PTSD in an integrative therapy module, and consisting of exposure to the loss memory, detailed written reconstruction of the loss memory narrative and an elaboration of the personal significance of that memory for the bereaved, has been shown to be effective in the treatment of intrusion symptoms. Objective: In light of findings that cognitive behavior therapy (CBT, including cognitive restructuring and exposure, is effective in the treatment of PGD, we suggest the implementation of a somewhat novel therapy module, NR, for the treatment of intrusive phenomena in bereaved patients. Method: The rationale for the implementation of NR for PGD and a case study of the treatment of a woman suffering from PGD after the death of her father are presented. Therapy took place in a university outpatient training clinic. Results: Evaluations conducted before and after treatment and at a 3-month follow-up demonstrated the effectiveness of NR in reducing symptoms of PGD and depression. The analysis of spontaneous narratives recorded before and after treatment showed an increased organization of the narratives. Conclusions: This case report demonstrates an adaptation of NR for the treatment of PGD. The results provide preliminary support for the effectiveness of NR for PGD. The significance of the study and its limitations are discussed.

The dissociative subtype of posttraumatic stress disorder: rationale, clinical and neurobiological evidence, and implications.

Science.gov (United States)

Lanius, Ruth A; Brand, Bethany; Vermetten, Eric; Frewen, Paul A; Spiegel, David

2012-08-01

Clinical and neurobiological evidence for a dissociative subtype of posttraumatic stress disorder (PTSD) has recently been documented. A dissociative subtype of PTSD is being considered for inclusion in the forthcoming Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5) to address the symptoms of depersonalization and derealization found among a subset of patients with PTSD. This article reviews research related to the dissociative subtype including antecedent, concurrent, and predictive validators as well as the rationale for recommending the dissociative subtype. The relevant literature pertaining to the dissociative subtype of PTSD was reviewed. Latent class analyses point toward a specific subtype of PTSD consisting of symptoms of depersonalization and derealization in both veteran and civilian samples of PTSD. Compared to individuals with PTSD, those with the dissociative subtype of PTSD also exhibit a different pattern of neurobiological response to symptom provocation as well as a differential response to current cognitive behavioral treatment designed for PTSD. We recommend that consideration be given to adding a dissociative subtype of PTSD in the revision of the DSM. This facilitates more accurate analysis of different phenotypes of PTSD, assist in treatment planning that is informed by considering the degree of patients' dissociativity, will improve treatment outcome, and will lead to much-needed research about the prevalence, symptomatology, neurobiology, and treatment of individuals with the dissociative subtype of PTSD. © 2012 Wiley Periodicals, Inc.

The Mediterranean healthy eating, ageing, and lifestyle (MEAL) study: rationale and study design.

Science.gov (United States)

Grosso, Giuseppe; Marventano, Stefano; D'Urso, Maurizio; Mistretta, Antonio; Galvano, Fabio

2017-08-01

There is accumulating evidence suggesting that Mediterranean lifestyles, including nutrition and sleeping patterns as well as social integration, may play a role in reducing age-related diseases. However, the literature is mostly deficient of evidence provided by Italian Mediterranean islands that more closely adhered to the originally described lifestyles. In this paper, we described the rationale and the study design of the Mediterranean healthy Eating, Ageing, and Lifestyle (MEAL) study, a prospective population-based cohort established in Sicily, southern Italy. The main exposures investigated are classical determinants of health, including demographic, nutritional habits, smoking and physical activity status, as well as eating-related behaviors, sleeping habits, sun exposure, social resources, and perceived stress. Anthropometric measurements will be collected. The main outcomes included depression, quality of life, and, after the follow-up period, also cardiovascular disease and cancer. The MEAL study may provide important data to increase our knowledge regarding the prevalence, incidence, and risk factors of age-related disorders in the Mediterranean region.

New Rationales for Women on Boards

OpenAIRE

Choudhury, B.

2014-01-01

Should measures promoting women to corporate boards be solely justified in terms of economic arguments? Traditionally, such measures have tended to rely on utilitarian arguments, despite the fact that the most prominent of these arguments—the relationship between women’s presence on boards and firm financial performance—is equivocal. Conversely, this article argues that rationales for increasing women on boards should be based on both equality and economics grounds. An equality rationale is n...

Rationales for the Lightning Launch Commit Criteria

Science.gov (United States)

Willett, John C. (Editor); Merceret, Francis J. (Editor); Krider, E. Philip; O'Brien, T. Paul; Dye, James E.; Walterscheid, Richard L.; Stolzenburg, Maribeth; Cummins, Kenneth; Christian, Hugh J.; Madura, John T.

2016-01-01

Since natural and triggered lightning are demonstrated hazards to launch vehicles, payloads, and spacecraft, NASA and the Department of Defense (DoD) follow the Lightning Launch Commit Criteria (LLCC) for launches from Federal Ranges. The LLCC were developed to prevent future instances of a rocket intercepting natural lightning or triggering a lightning flash during launch from a Federal Range. NASA and DoD utilize the Lightning Advisory Panel (LAP) to establish and develop robust rationale from which the criteria originate. The rationale document also contains appendices that provide additional scientific background, including detailed descriptions of the theory and observations behind the rationales. The LLCC in whole or part are used across the globe due to the rigor of the documented criteria and associated rationale. The Federal Aviation Administration (FAA) adopted the LLCC in 2006 for commercial space transportation and the criteria were codified in the FAA's Code of Federal Regulations (CFR) for Safety of an Expendable Launch Vehicle (Appendix G to 14 CFR Part 417, (G417)) and renamed Lightning Flight Commit Criteria in G417.

A Multi-site, Two-Phase, Prescription Opioid Addiction Treatment Study (POATS): Rationale, Design, and Methodology

Science.gov (United States)

Weiss, Roger D.; Potter, Jennifer Sharpe; Provost, Scott E.; Huang, Zhen; Jacobs, Petra; Hasson, Albert; Lindblad, Robert; Connery, Hilary Smith; Prather, Kristi; Ling, Walter

2010-01-01

The National Institute on Drug Abuse Clinical Trials Network launched the Prescription Opioid Addiction Treatment Study (POATS) in response to rising rates of prescription opioid dependence and gaps in understanding the optimal course of treatment for this population. POATS employed a multi-site, two-phase adaptive, sequential treatment design to approximate clinical practice. The study took place at 10 community treatment programs around the United States. Participants included men and women age ≥18 who met Diagnostic and Statistical Manual, 4th Edition criteria for dependence upon prescription opioids, with physiologic features; those with a prominent history of heroin use (according to pre-specified criteria) were excluded. All participants received buprenorphine/naloxone (bup/nx). Phase 1 consisted of 4 weeks of bup/nx treatment, including a 14-day dose taper, with 8 weeks of follow-up. Phase 1 participants were monitored for treatment response during these 12 weeks. Those who relapsed to opioid use, as defined by pre-specified criteria, were invited to enter Phase 2; Phase 2 consisted of 12 weeks of bup/nx stabilization treatment, followed by a 4-week taper and 8 weeks of post-treatment follow-up. Participants were randomized at the beginning of Phase 1 to receive bup/nx, paired with either Standard Medical Management (SMM) or Enhanced Medical Management (EMM; defined as SMM plus individual drug counseling). Eligible participants entering Phase 2 were re-randomized to either EMM or SMM. POATS was developed to determine what benefit, if any, EMM offers over SMM in short-term and longer-term treatment paradigm. This paper describes the rationale and design of the study. PMID:20116457

Study design and rationale for biomedical shirt-based electrocardiography monitoring in relevant clinical situations: ECG-shirt study.

Science.gov (United States)

Balsam, Paweł; Lodziński, Piotr; Tymińska, Agata; Ozierański, Krzysztof; Januszkiewicz, Łukasz; Główczyńska, Renata; Wesołowska, Katarzyna; Peller, Michał; Pietrzak, Radosław; Książczyk, Tomasz; Borodzicz, Sonia; Kołtowski, Łukasz; Borkowski, Mariusz; Werner, Bożena; Opolski, Grzegorz; Grabowski, Marcin

2018-01-01

Today, the main challenge for researchers is to develop new technologies which may help to improve the diagnoses of cardiovascular disease (CVD), thereby reducing healthcare costs and improving the quality of life for patients. This study aims to show the utility of biomedical shirt-based electrocardiography (ECG) monitoring of patients with CVD in different clinical situations using the Nuubo® ECG (nECG) system. An investigator-initiated, multicenter, prospective observational study was carried out in a cardiology (adult and pediatric) and cardiac rehabilitation wards. ECG monitoring was used with the biomedical shirt in the following four independent groups of patients: 1) 30 patients after pulmonary vein isolation (PVI), 2) 30 cardiac resynchronization therapy (CRT) recipients, 3) 120 patients during cardiac rehabilitation after myocardial infarction, and 4) 40 pediatric patients with supraventricular tachycardia (SVT) before electrophysiology study. Approval for all study groups was obtained from the institutional review board. The biomedical shirt captures the electrocardiographic signal via textile electrodes integrated into a garment. The software allows the visualization and analysis of data such as ECG, heart rate, arrhythmia detecting algorithm and relative position of the body is captured by an electronic device. The major advantages of the nECG system are continuous ECG monitoring during daily activities, high quality of ECG recordings, as well as assurance of a proper adherence due to adequate comfort while wearing the shirt. There are only a few studies that have examined wearable systems, especially in pediatric populations. This study is registered in ClinicalTrials.gov: Identifier NCT03068169. (Cardiol J 2018; 25, 1: 52-59).

'Trial Exegesis': Methods for Synthesizing Clinical and Patient Reported Outcome (PRO Data in Trials to Inform Clinical Practice. A Systematic Review.

Directory of Open Access Journals (Sweden)

Angus G K McNair

Full Text Available The CONSORT extension for patient reported outcomes (PROs aims to improve reporting, but guidance on the optimal integration with clinical data is lacking. This study examines in detail the reporting of PROs and clinical data from randomized controlled trials (RCTs in gastro-intestinal cancer to inform design and reporting of combined PRO and clinical data from trials to improve the 'take home' message for clinicians to use in practice.The case study was undertaken in gastro-intestinal cancer trials. Well-conducted RCTs reporting PROs with validated instruments were identified and categorized into those combining PRO and clinical data in a single paper, or those separating data into linked primary and supplemental papers. Qualitative methods were developed to examine reporting of the critical interpretation of the trial results (trial exegesis in the papers in relation of the PRO and clinical outcomes and applied to each publication category. Results were used to inform recommendations for practice.From 1917 screened abstracts, 49 high quality RCTs were identified reported in 36 combined and 15 linked primary and supplemental papers. In-depth analysis of manuscript text identified three categories for understanding trial exegesis: where authors reported a "detailed", "general", or absent PRO rationale and integrated interpretation of clinical and PRO results. A total of 11 (30% and 6 (16% combined papers reported "detailed" PRO rationale and integrated interpretation of results although only 2 (14% and 1 (7% primary papers achieved the same standard respectively. Supplemental papers provide better information with 11 (73% and 3 (20% achieving "detailed" rationale and integrated interpretation of results. Supplemental papers, however, were published a median of 20 months after the primary RCT data in lower impact factor journals (median 16.8 versus 5.2.It is recommended that single papers, with detailed PRO rationale and integrated PRO and

The rationale of scored tablets as dosage form.

NARCIS (Netherlands)

Rodenhuis, N.; Smet, P.A.G.M. de; Barends, D.M.

2004-01-01

The aim of the study was to get insight into the rationale of scored tablets. This was pursued by studying patient's reasons for subdividing ("breaking") scored and unscored tablets. Patients who picked up their prescriptions in 5 community pharmacies in The Netherlands were questioned. Two-hundred

Astigmatism treatment during phacoemulsification: a review of current surgical strategies and their rationale

Directory of Open Access Journals (Sweden)

Giuliano de Oliveira Freitas

2013-12-01

Full Text Available Preexisting corneal astigmatism, present at the time of cataract surgery, is reviewed in detail throughout this article on its most important aspects such as occurrence rates, clinical relevance and current treatment options. Special emphasis is given to the latter aspect. Each method's rationale, advantage and limitation ishigh lightened. Comparisons between treatment options, whenever possible, are also provided.

Description and Rationale for the Planning, Monitoring, and Implementation (PMI) Model: Rationale.

Science.gov (United States)

Cort, H. Russell

The rationale for the Planning, Monitoring, and Implementation Model (PMI) is the subject of this paper. The Superintendent of the District of Columbia Public Schools requested a model for systematic evaluation of educational programs to determine their effectiveness. The school system's emphasis on objective-referenced instruction and testing,…

USE OF REMICADE® IN PATIENTS WITH CHRONIC TOPHACEOUS GOUT: THEORETICAL RATIONALE AND ASSESSMENT OFOWN EXPERIENCE

Directory of Open Access Journals (Sweden)

M S Eliseyev

2009-01-01

Full Text Available The paper deals with the clinical experience in using Remicade®, a tumor necrosis factor-a (TNF-а inhibitor, in patients with chronic tophaceous gout resistant to therapy with glucocorticoids and nonsteroidal anti-inflammatory drugs. The agent is noted to have a good long-acting clinical effect in reducing the number of tender and swollen joints, as confirmed by the theoretical rationale for the use of anticytokine agents, TNF- а inhibitors in particular, in gouty patients.

Design and rationale for examining neuroimaging genetics in ischemic stroke

Science.gov (United States)

Giese, Anne-Katrin; Schirmer, Markus D.; Donahue, Kathleen L.; Cloonan, Lisa; Irie, Robert; Winzeck, Stefan; Bouts, Mark J.R.J.; McIntosh, Elissa C.; Mocking, Steven J.; Dalca, Adrian V.; Sridharan, Ramesh; Xu, Huichun; Frid, Petrea; Giralt-Steinhauer, Eva; Holmegaard, Lukas; Roquer, Jaume; Wasselius, Johan; Cole, John W.; McArdle, Patrick F.; Broderick, Joseph P.; Jimenez-Conde, Jordi; Jern, Christina; Kissela, Brett M.; Kleindorfer, Dawn O.; Lemmens, Robin; Lindgren, Arne; Meschia, James F.; Rundek, Tatjana; Sacco, Ralph L.; Schmidt, Reinhold; Sharma, Pankaj; Slowik, Agnieszka; Thijs, Vincent; Woo, Daniel; Worrall, Bradford B.; Kittner, Steven J.; Mitchell, Braxton D.; Rosand, Jonathan; Golland, Polina; Wu, Ona

2017-01-01

Objective: To describe the design and rationale for the genetic analysis of acute and chronic cerebrovascular neuroimaging phenotypes detected on clinical MRI in patients with acute ischemic stroke (AIS) within the scope of the MRI–GENetics Interface Exploration (MRI-GENIE) study. Methods: MRI-GENIE capitalizes on the existing infrastructure of the Stroke Genetics Network (SiGN). In total, 12 international SiGN sites contributed MRIs of 3,301 patients with AIS. Detailed clinical phenotyping with the web-based Causative Classification of Stroke (CCS) system and genome-wide genotyping data were available for all participants. Neuroimaging analyses include the manual and automated assessments of established MRI markers. A high-throughput MRI analysis pipeline for the automated assessment of cerebrovascular lesions on clinical scans will be developed in a subset of scans for both acute and chronic lesions, validated against gold standard, and applied to all available scans. The extracted neuroimaging phenotypes will improve characterization of acute and chronic cerebrovascular lesions in ischemic stroke, including CCS subtypes, and their effect on functional outcomes after stroke. Moreover, genetic testing will uncover variants associated with acute and chronic MRI manifestations of cerebrovascular disease. Conclusions: The MRI-GENIE study aims to develop, validate, and distribute the MRI analysis platform for scans acquired as part of clinical care for patients with AIS, which will lead to (1) novel genetic discoveries in ischemic stroke, (2) strategies for personalized stroke risk assessment, and (3) personalized stroke outcome assessment. PMID:28852707

Teacher Grading Decisions: Influences, Rationale, and Practices

Science.gov (United States)

Kunnath, Joshua P.

2017-01-01

This mixed-methods study applied a decision-making theoretical framework to an investigation of teacher grading in a large urban school district in California. A sample of 251 high school teachers of core subjects were surveyed, and 15 teachers participated in four focus group interviews in order provide data on the influences, rationale, and…

Rationale and design of the BUDAPEST-CRT Upgrade Study: a prospective, randomized, multicentre clinical trial.

Science.gov (United States)

Merkely, Bela; Kosztin, Annamaria; Roka, Attila; Geller, Laszlo; Zima, Endre; Kovacs, Attila; Boros, Andras Mihaly; Klein, Helmut; Wranicz, Jerzy K; Hindricks, Gerhard; Clemens, Marcell; Duray, Gabor Z; Moss, Arthur J; Goldenberg, Ilan; Kutyifa, Valentina

2017-09-01

There is lack of conclusive evidence from randomized clinical trials on the efficacy and safety of upgrade to cardiac resynchronization therapy (CRT) in patients with implanted pacemakers (PM) or defibrillators (ICD) with reduced left ventricular ejection fraction (LVEF) and chronic heart failure (HF). The BUDAPEST-CRT Upgrade Study was designed to compare the efficacy and safety of CRT upgrade from conventional PM or ICD therapy in patients with intermittent or permanent right ventricular (RV) septal/apical pacing, reduced LVEF, and symptomatic HF. The BUDAPEST-CRT study is a prospective, randomized, multicentre, investigator-sponsored clinical trial. A total of 360 subjects will be enrolled with LVEF ≤ 35%, NYHA functional classes II-IVa, paced QRS ≥ 150 ms, and a RV pacing ≥ 20%. Patients will be followed for 12 months. Randomization is performed in a 3:2 ratio (CRT-D vs. ICD). The primary composite endpoint is all-cause mortality, a first HF event, or less than 15% reduction in left ventricular (LV) end-systolic volume at 12 months. Secondary endpoints are all-cause mortality, all-cause mortality or HF event, and LV volume reduction at 12 months. Tertiary endpoints include changes in quality of life, NYHA functional class, 6 min walk test, natriuretic peptides, and safety outcomes. The results of our prospective, randomized, multicentre clinical trial will provide important information on the role of cardiac resynchronization therapy with defibrillator (CRT-D) upgrade in patients with symptomatic HF, reduced LVEF, and wide-paced QRS with intermittent or permanent RV pacing. NCT02270840. © The Author 2016. Published by Oxford University Press on behalf of the European Society of Cardiology.

An anthology: Rationale for a US ballistic missile defense (1969 - 1984)

Science.gov (United States)

Tircuit, E. C.

1985-04-01

This anthology is a selection and short synopsis of representative articles on the rationale for a US ballistic missile defense (BMD). Unclassified articles and documents were reviewed and analyzed to identify and include nine representative articles in the anthology. The anthology reduces the search for quality material on the subject and documents the fundamental rationale for a BMD. The author concluded that the fundamental rationale for a US BMD is to deter nuclear war. In addition, specific rationale for a US BMD is provided in the anthology. Finally, an extensive bibliography is included in the anthology to enhance further research on the subject.

Rapid arc - clinical rationale and results

International Nuclear Information System (INIS)

Cozzi, Lucca

2008-01-01

The presentation will focus on the background of Intensity modulation volumetric arc therapy Rapid Arc from Varian Medical Systems aiming to highlight the technical and clinical rational also from an historical perspective to the founding pillars of fast delivery with a minimum number of arcs and a minimum number of monitor units

Non-Hematopoietic Essential Functions of Bone Marrow Cells: A Review of Scientific and Clinical Literature and Rationale for Treating Bone Defects.

Science.gov (United States)

Harrell, David B; Caradonna, Eugenio; Mazzucco, Laura; Gudenus, Rosmarie; Amann, Berthold; Prochazka, Vaclav; Giannoudis, Peter V; Hendrich, Christian; Jäger, Marcus; Krauspe, Rüdiger; Hernigou, Philippe

2015-12-28

Hematopoiesis as the only essential function of bone marrow cells has been challenged for several decades through basic science (in vitro and in vivo) and clinical data. Such work has shed light on two other essential functions of bone marrow cells: osteopoiesis and angio-genesis/vasculogenesis. Clinical utility of autologous concentrated bone marrow aspirate (CBMA) has demonstrated both safety and efficacy in treating bone defects. Moreover, CBMA has been shown to be comparable to the gold standard of iliac crest bone graft (ICBG), or autograft, with regard to being osteogenic and osteoinductive. ICBG is not considered an advanced therapy medicinal product (ATMP), but CBMA may become regulated as an ATMP. The European Medicines Agency Committee for Advanced Therapies (EMA:CAT) has issued a reflection paper (20 June 2014) in which reversal of the 2013 ruling that CBMA is a non-ATMP has been proposed. We review bone marrow cell involvement in osteopoiesis and angiogenesis/vasculogenesis to examine EMA:CAT 2013 decision to use CBMA for treatment of osteonecrosis (e.g, of the femoral head) should be considered a non-ATMP. This paper is intended to provide discussion on the 20 June 2014 reflection paper by reviewing two non-hematopoietic essential functions of bone marrow cells. Additionally, we provide clinical and scientific rationale for treating osteonecrosis with CBMA.

Non-hematopoietic essential functions of bone marrow cells: a review of scientific and clinical literature and rationale for treating bone defects

Directory of Open Access Journals (Sweden)

David B. Harrell

2015-12-01

Full Text Available Hematopoiesis as the only essential function of bone marrow cells has been challenged for several decades through basic science (in vitro and in vivo and clinical data. Such work has shed light on two other essential functions of bone marrow cells: osteopoiesis and angiogenesis/vasculogenesis. Clinical utility of autologous concentrated bone marrow aspirate (CBMA has demonstrated both safety and efficacy in treating bone defects. Moreover, CBMA has been shown to be comparable to the gold standard of iliac crest bone graft (ICBG, or autograft, with regard to being osteogenic and osteoinductive. ICBG is not considered an advanced therapy medicinal product (ATMP, but CBMA may become regulated as an ATMP. The European Medicines Agency Committee for Advanced Therapies (EMA:CAT has issued a reflection paper (20 June 2014 in which reversal of the 2013 ruling that CBMA is a non-ATMP has been proposed. We review bone marrow cell involvement in osteopoiesis and angiogenesis/vasculogenesis to examine EMA:CAT 2013 decision to use CBMA for treatment of osteonecrosis (e.g, of the femoral head should be considered a non-ATMP. This paper is intended to provide discussion on the 20 June 2014 reflection paper by reviewing two non-hematopoietic essential functions of bone marrow cells. Additionally, we provide clinical and scientific rationale for treating osteonecrosis with CBMA.

A beginner's guide to writing the nursing conceptual model-based theoretical rationale.

Science.gov (United States)

Gigliotti, Eileen; Manister, Nancy N

2012-10-01

Writing the theoretical rationale for a study can be a daunting prospect for novice researchers. Nursing's conceptual models provide excellent frameworks for placement of study variables, but moving from the very abstract concepts of the nursing model to the less abstract concepts of the study variables is difficult. Similar to the five-paragraph essay used by writing teachers to assist beginning writers to construct a logical thesis, the authors of this column present guidelines that beginners can follow to construct their theoretical rationale. This guide can be used with any nursing conceptual model but Neuman's model was chosen here as the exemplar.

The Reversal Intervention for Metabolic Syndrome (TRIMS study: rationale, design, and baseline data

Directory of Open Access Journals (Sweden)

Troughton Jacqui

2011-05-01

Full Text Available Abstract Background Recent attention has focused on strategies to combat the forecast epidemic of type-2 diabetes (T2DM and its major vascular sequelae. Metabolic syndrome (MetS comprises a constellation of factors that increase the risk of cardiovascular disease (CVD and T2DM. Our study aims to develop a structured self-management education programme for people with MetS, which includes management of cardiovascular and diabetes risk factors, and to determine its impact. This paper describes the rationale and design of the TRIMS study, including intervention development, and presents baseline data. Methods Subjects recruited from a mixed-ethnic population with MetS were randomised to intervention or control arms. The intervention arm received structured group education based on robust psychological theories and current evidence. The control group received routine care. Follow-up data will be collected at 6 and 12 months. The primary outcome measure will be reversal of metabolic syndrome in the intervention group subjects compared to controls at 12 months follow-up. Results 82 participants (44% male, 22% South Asian were recruited between November 2009 and July 2010. Baseline characteristics were similar for both the intervention (n = 42 and control groups (n = 40. Median age was 63 years (IQR 57 - 67, mean waist size 106 cm (SD ± 11, and prescribing of statins and anti-hypertensives was 51% in each case. Conclusion Results will provide information on changes in diabetes and CVD risk factors and help to inform primary prevention strategies in people with MetS from varied ethnic backgrounds who are at high risk of developing T2DM and CVD. Information gathered in relation to the programme's acceptability and effectiveness in a multi-ethnic population would ensure that our results are widely applicable. Trial registration The study is registered at ClinicalTrials.gov, study identifier: NCT01043770.

Clinical use of quantitative cardiac perfusion PET: rationale, modalities and possible indications. Position paper of the Cardiovascular Committee of the European Association of Nuclear Medicine (EANM)

International Nuclear Information System (INIS)

Sciagra, Roberto; Passeri, Alessandro; Bucerius, Jan; Verberne, Hein J.; Slart, Riemer H.J.A.; Lindner, Oliver; Gimelli, Alessia; Hyafil, Fabien; Agostini, Denis; Uebleis, Christopher; Hacker, Marcus

2016-01-01

Until recently, PET was regarded as a luxurious way of performing myocardial perfusion scintigraphy, with excellent image quality and diagnostic capabilities that hardly justified the additional cost and procedural effort. Quantitative perfusion PET was considered a major improvement over standard qualitative imaging, because it allows the measurement of parameters not otherwise available, but for many years its use was confined to academic and research settings. In recent years, however, several factors have contributed to the renewal of interest in quantitative perfusion PET, which has become a much more readily accessible technique due to progress in hardware and the availability of dedicated and user-friendly platforms and programs. In spite of this evolution and of the growing evidence that quantitative perfusion PET can play a role in the clinical setting, there are not yet clear indications for its clinical use. Therefore, the Cardiovascular Committee of the European Association of Nuclear Medicine, starting from the experience of its members, decided to examine the current literature on quantitative perfusion PET to (1) evaluate the rationale for its clinical use, (2) identify the main methodological requirements, (3) identify the remaining technical difficulties, (4) define the most reliable interpretation criteria, and finally (5) tentatively delineate currently acceptable and possibly appropriate clinical indications. The present position paper must be considered as a starting point aiming to promote a wider use of quantitative perfusion PET and to encourage the conception and execution of the studies needed to definitely establish its role in clinical practice. (orig.)

Placebo versus "standard" hypnosis rationale: attitudes, expectancies, hypnotic responses, and experiences.

Science.gov (United States)

Accardi, Michelle; Cleere, Colleen; Lynn, Steven Jay; Kirsch, Irving

2013-10-01

In this study participants were provided with either the standard rationale that accompanies the Harvard Group Scale of Hypnotic Susceptibility: A (Shor & Orne, 1962) or a rationale that presented hypnosis as a nondeceptive placebo, consistent with Kirsch's (1994) sociocognitive perspective of hypnosis. The effects of the placebo and standard rationales were highly comparable with respect to hypnotic attitudes; prehypnotic expectancies; objective, subjective, and involuntariness measures of hypnotic responding; as well as a variety of subjective experiences during hypnosis, as measured by the Phenomenology of Consciousness Inventory (Pekala, 1982). Differences among correlations were not evident when measures were compared across groups. However, indices of hypnotic responding were correlated with attitudes in the hypnosis but not the placebo condition, and, generally speaking, the link between subjective experiences during hypnosis and measures of hypnotic responding were more reliable in the placebo than the hypnosis group. Researcher findings are neutral with respect to providing support for altered state versus sociocognitive models of hypnosis.

Nature of Science Progression in School Year 1-9: a Case Study of Teachers' Suggestions and Rationales

Science.gov (United States)

Leden, Lotta; Hansson, Lena

2017-07-01

The inclusion of nature of science (NOS) in science education has for a long time been regarded as crucial. There is, however, a lack of research on appropriate NOS aspects for different educational levels. An even more neglected area of research is that focusing on teachers' perspectives on NOS teaching at different levels. The aim of this article is to examine NOS progression in the light of teachers' suggestions and rationales. In order to obtain teachers' informed perspectives, we chose to involve six teachers (teaching grades 1-9) in a 3-year research project. They took part in focus group discussions about NOS and NOS teaching as well as implemented jointly planned NOS teaching sessions. Data that this article builds on was collected at the end of the project. The teachers' suggestions for NOS progression often relied on adding more NOS issues at every stage, thereby creating the foundations of a broader but not necessarily deeper understanding of NOS. Five rationales, for if/when specific NOS issues are appropriate to introduce, emerged from the analysis of the teacher discussions. Some of these rationales, including practice makes perfect and increasing levels of depth can potentially accommodate room for many NOS issues in the science classroom, while maturity and experience instead has a restricting effect on NOS teaching. Also, choice of context and teaching approaches play an important role in teachers' rationales for whether specific NOS issues should be included or not at different stages. The article discusses the implications for teacher education and professional development.

Longitudinal Andhra Pradesh Eye Disease Study: rationale, study design and research methodology.

Science.gov (United States)

Khanna, Rohit C; Murthy, Gudlavalleti Vs; Marmamula, Srinivas; Mettla, Asha Latha; Giridhar, Pyda; Banerjee, Seema; Shekhar, Konegari; Chakrabarti, Subhabrata; Gilbert, Clare; Rao, Gullapalli N

2016-03-01

The rationale, objectives, study design and procedures for the longitudinal Andhra Pradesh Eye Disease Study are described. A longitudinal cohort study was carried out. Participants include surviving cohort from the rural component of Andhra Pradesh Eye Disease Study. During 1996-2000, Andhra Pradesh Eye Disease Survey was conducted in three rural (n = 7771) and one urban (n = 2522) areas (now called Andhra Pradesh Eye Disease Study 1). In 2009-2010, a feasibility exercise (Andhra Pradesh Eye Disease Study 2) for a longitudinal study (Andhra Pradesh Eye Disease Study 3) was undertaken in the rural clusters only, as urban clusters no longer existed. In Andhra Pradesh Eye Disease Study 3, a detailed interview will be carried out to collect data on sociodemographic factors, ocular and systemic history, risk factors, visual function, knowledge of eye diseases and barriers to accessing services. All participants will also undergo a comprehensive eye examination including photography of lens, optic disc and retina, Optic Coherence Tomography of the posterior segment, anthropometry, blood pressure and frailty measures. Measures include estimates of the incidence of visual impairment and age-related eye disease (lens opacities, glaucoma and age-related macular degeneration) and the progression of eye disease (lens opacities and myopia) and associated risk factors. Of the 7771 respondents examined in rural areas in Andhra Pradesh Eye Disease Study 1, 5447 (70.1%) participants were traced in Andhra Pradesh Eye Disease Study 2. These participants will be re-examined. Andhra Pradesh Eye Disease Study 3 will provide data on the incidence and progression of visual impairment and major eye diseases and their associated risk factors in India. The study will provide further evidence to aid planning eye care services. © 2015 Royal Australian and New Zealand College of Ophthalmologists.

Bioethics: A Rationale and a Model

Science.gov (United States)

Barman, Charles R.; Rusch, John J.

1978-01-01

Discusses the rationale for and development of an undergraduate bioethics course. Based on experiences with the course, general suggestions are offered to instructors planning to add bioethics to existing curricula. (MA)

Rationales behind the choice of administration form with fentanyl

DEFF Research Database (Denmark)

Jacobsen, Ramune; Møldrup, Claus; Christrup, Lona

2010-01-01

BACKGROUND AND AIM: The aim of this study was to describe the rationale behind the choice of fentanyl administration forms among Danish general practitioners (GPs). METHODS: Thirty-eight Danish GPs were contacted via an Internet survey system to perform a Delphi survey. In the brainstorming phase...

"Socialized Music": Historical Formations of Community Music through Social Rationales

Science.gov (United States)

Yerichuk, Deanna

2014-01-01

This article traces the formation of community music through professional and scholarly articles over the last century in North America, and argues that community music has been discursively formed through social rationales, although the specific rationales have shifted. The author employs an archaeological framework inspired by Michel Foucault to…

Operationalizing "trance". I: Rationale and research using a psychophenomenological approach.

Science.gov (United States)

Pekala, R J; Kumar, V K

2000-10-01

Despite the popularity of the term "trance" among clinicians to describe the subjective effects associated with being hypnotized, heretofore there has been no means to operationalize that definition. The authors present a rationale and psychophenomenological method to operationalize the term "trance" in terms of (a) hypnotic depth, a quantitative measure of subjective trance assessed via a pHGS (predicted Harvard Group Scale) score, derived from regression analysis, and (b) "trance typology profiles," a qualitative differentiation of empirically derived (via cluster and discriminant analyses) categories of subjective trance experiences. The authors then discuss theoretical and clinical implications of this psychophenomenological approach for developing an operational definition of the concept of trance.

Effect of genetic testing for risk of type 2 diabetes mellitus on health behaviors and outcomes: study rationale, development and design

Directory of Open Access Journals (Sweden)

Cho Alex H

2012-01-01

Full Text Available Abstract Background Type 2 diabetes is a prevalent chronic condition globally that results in extensive morbidity, decreased quality of life, and increased health services utilization. Lifestyle changes can prevent the development of diabetes, but require patient engagement. Genetic risk testing might represent a new tool to increase patients' motivation for lifestyle changes. Here we describe the rationale, development, and design of a randomized controlled trial (RCT assessing the clinical and personal utility of incorporating type 2 diabetes genetic risk testing into comprehensive diabetes risk assessments performed in a primary care setting. Methods/Design Patients are recruited in the laboratory waiting areas of two primary care clinics and enrolled into one of three study arms. Those interested in genetic risk testing are randomized to receive either a standard risk assessment (SRA for type 2 diabetes incorporating conventional risk factors plus upfront disclosure of the results of genetic risk testing ("SRA+G" arm, or the SRA alone ("SRA" arm. Participants not interested in genetic risk testing will not receive the test, but will receive SRA (forming a third, "no-test" arm. Risk counseling is provided by clinic staff (not study staff external to the clinic. Fasting plasma glucose, insulin levels, body mass index (BMI, and waist circumference are measured at baseline and 12 months, as are patients' self-reported behavioral and emotional responses to diabetes risk information. Primary outcomes are changes in insulin resistance and BMI after 12 months; secondary outcomes include changes in diet patterns, physical activity, waist circumference, and perceived risk of developing diabetes. Discussion The utility, feasibility, and efficacy of providing patients with genetic risk information for common chronic diseases in primary care remain unknown. The study described here will help to establish whether providing type 2 diabetes genetic risk

Improving metabolic parameters of antipsychotic child treatment (IMPACT) study: rationale, design, and methods

OpenAIRE

Reeves, Gloria M; Keeton, Courtney; Correll, Christoph U; Johnson, Jacqueline L; Hamer, Robert M; Sikich, Linmarie; Hazzard, Lindsey; Alderman, Cheryl; Scheer, Abigail; Mabe, Micah; Kapoor, Sandeep; Sheridan, Eva; Borner, Irmgard; Bussell, Kristin; Pirmohamed, Sara

2013-01-01

Background Youth with serious mental illness may experience improved psychiatric stability with second generation antipsychotic (SGA) medication treatment, but unfortunately may also experience unhealthy weight gain adverse events. Research on weight loss strategies for youth who require ongoing antipsychotic treatment is quite limited. The purpose of this paper is to present the design, methods, and rationale of the Improving Metabolic Parameters in Antipsychotic Child Treatment (IMPACT) stu...

A review of the benefits and rationale of viewing liver window settings for abdominal computed tomography scans

International Nuclear Information System (INIS)

Dang, Tan; Mandarano, Giovanni

2006-01-01

There have been many different opinions over the efficacy of routinely incorporating liver-window settings in abdominal computed tomography (CT) scans. As a result, different clinical centres have varying protocols for incorporating liver-windows for abdominal CT scans. This investigation aims to explore and determine whether various clinical centres throughout Victoria use liver-window settings selectively or routinely and their justification for doing so. An additional purpose is also to assess the benefits and rationale of liver-window settings in supplementing routine soft-tissue-windows for abdominal CT examinations by reviewing evidenced-based studies. Surveys were sent out to CT supervisors at various clinical centres, including private and public institutions. This achieved an overall response rate of 74 per cent. Results indicate that the majority of clinical centres throughout Victoria routinely incorporate liver-window settings for all abdominal CT examinations. Forty four per cent (11/25) of respondents stated that they utilise liver-window settings selectively for abdominal CT examinations. Most of these respondents (7/11 = 63 per cent) believed that soft-tissue-window settings alone are adequate to demonstrate hepatic lesions; particularly if intravenous contrast media is used and the liver is captured in the arterial, venous and/or delayed phases. The benefits and rationale of incorporating liver-window settings for all abdominal computed tomography scans has been questioned by two well noted studies in the United States. These evidence-based studies suggest that such additional settings do not offer further advantages in detecting hepatic disease, when compared to soft-tissue-windows alone. Review of the available literature provides additional evidence suggesting that the routine use of liver-window settings in conjunction with soft-tissue-windows offers no further advantages in the detection of hepatic diseases. This investigation found, however

Appendix C: safety design rationale

International Nuclear Information System (INIS)

Ghose, S.

1985-01-01

A brief discussion of the rationale for safety design of fusion plants is presented in the main text. Further detail safety considerations are presented in this appendix in the form of charts and tables. The author present some of the major safety criteria and other criteria used in blanket selection here

Glucocorticoid augmentation of prolonged exposure therapy: rationale and case report

Directory of Open Access Journals (Sweden)

Laura Pratchett

2010-12-01

Full Text Available Rationale: Prolonged exposure (PE therapy has been found to reduce symptoms of posttraumatic stress disorder (PTSD; however, it is difficult for many patients to engage fully in the obligatory retelling of their traumatic experiences. This problem is compounded by the fact that habituation and cognitive restructuring – the main mechanisms through which PE is hypothesized to work – are not instantaneous processes, and often require several weeks before the distress associated with imaginal exposure abates. Case reports: Two cases are described that respectively illustrate the use of hydrocortisone and placebo, in combination with PE, for the treatment of combat-related PTSD. Based on known effects of glucocorticoids on learning and memory performance, we hypothesized that augmentation with hydrocortisone would improve the therapeutic effects of PE by hastening “new” learning and facilitating decreases in the emotional impact of fear memories during the course of treatment. The veteran receiving hydrocortisone augmentation of PE displayed an accelerated and ultimately greater decline in PTSD symptoms than the veteran receiving placebo. Conclusions: While no general conclusion can be derived from comparison of two patients, the findings are consistent with the rationale for augmentation. These case reports support the potential for an appropriately designed and powered clinical trial to examine the efficacy of glucocorticoids in augmenting the effects of psychotherapy for PTSD.

Meeting a Moral Imperative: A Rationale for Teaching the Holocaust

Science.gov (United States)

Lindquist, David H.

2011-01-01

A primary rationale for studying the Holocaust (Shoah) involves the opportunity to consider the moral implications that can be drawn from examining the event. Studying the Shoah forces students to consider what it means to be human and humane by examining the full continuum of individual behavior, from "ultimate evil" to "ultimate good". This…

Rationale and Design of the 'MITOCARE' Study

DEFF Research Database (Denmark)

Clemmensen, Peter

2012-01-01

resonance). The study is being financed under an EU-FP7 grant and conducted under the auspices of the MITOCARE research consortium, which includes experts from clinical and basic research centers, as well as commercial enterprises, throughout Europe. Results from this study will contribute to a better...

Rationale for combination of therapeutic antibodies targeting tumor cells and immune checkpoint receptors: Harnessing innate and adaptive immunity through IgG1 isotype immune effector stimulation.

Science.gov (United States)

Ferris, Robert L; Lenz, Heinz-Josef; Trotta, Anna Maria; García-Foncillas, Jesús; Schulten, Jeltje; Audhuy, François; Merlano, Marco; Milano, Gerard

2018-02-01

Immunoglobulin (Ig) G1 antibodies stimulate antibody-dependent cell-mediated cytotoxicity (ADCC). Cetuximab, an IgG1 isotype monoclonal antibody, is a standard-of-care treatment for locally advanced and recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) and metastatic colorectal cancer (CRC). Here we review evidence regarding the clinical relevance of cetuximab-mediated ADCC and other immune functions and provide a biological rationale concerning why this property positions cetuximab as an ideal partner for immune checkpoint inhibitors (ICIs) and other emerging immunotherapies. We performed a nonsystematic review of available preclinical and clinical data involving cetuximab-mediated immune activity and combination approaches of cetuximab with other immunotherapies, including ICIs, in SCCHN and CRC. Indeed, cetuximab mediates ADCC activity in the intratumoral space and primes adaptive and innate cellular immunity. However, counterregulatory mechanisms may lead to immunosuppressive feedback loops. Accordingly, there is a strong rationale for combining ICIs with cetuximab for the treatment of advanced tumors, as targeting CTLA-4, PD-1, and PD-L1 can ostensibly overcome these immunosuppressive counter-mechanisms in the tumor microenvironment. Moreover, combining ICIs (or other immunotherapies) with cetuximab is a promising strategy for boosting immune response and enhancing response rates and durability of response. Cetuximab immune activity-including, but not limited to, ADCC-provides a strong rationale for its combination with ICIs or other immunotherapies to synergistically and fully mobilize the adaptive and innate immunity against tumor cells. Ongoing prospective studies will evaluate the clinical effect of these combination regimens and their immune effect in CRC and SCCHN and in other indications. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

Achieving Both Creativity And Rationale: Reuse In Design With Images And Claims

Directory of Open Access Journals (Sweden)

D. Scott McCrickard

2011-01-01

Full Text Available Although designers often try to create novel designs, many designs are based on previous work. In this paper we argue for the reuse of rationale, in the form of claims, as a central activity in design, and explore how this can be used to inspire creativity. We present a design activity in which images and claims are reused to create a storyboard and illustrate how creativity and rationale complement each other. Our work serves to demonstrate that an appropriate design activity can be used to leverage creativity with the use of rationale.

The development of criteria for limiting the non-uniform irradiation of skin: the rationale for a study of non-stochastic effects

International Nuclear Information System (INIS)

Wells, J.; Charles, M.W.

1979-06-01

Recent recommendations of the ICRP (1977) provide little guidance for the treatment of non-uniform skin exposures such as those which may occur as the result of contamination with radioactive particulates. This lack of guidance is due to a paucity of data regarding biological effects in this area. A rationale is presented for the study of the early (non-stochastic) effects of non-uniform skin irradiation. As a basis for the presentation of this rationale a framework is provided by a resume of basic biology of the skin and a review of previous experimental work in this field. Animal experiments, which are being carried out in collaboration with specialist university groups, are described both in terms of broad concept and experimental detail. The aim is to provide biological data which can provide guidance in radiological protection situations. (author)

Design, rationale and feasibility of a multidimensional experimental protocol to study early life stress

Directory of Open Access Journals (Sweden)

M. Dillwyn Bartholomeusz

2017-09-01

Full Text Available There is a rapidly accumulating body of evidence regarding the influential role of early life stress (ELS upon medical and psychiatric conditions. While self-report instruments, with their intrinsic limitations of recall, remain the primary means of detecting ELS in humans, biological measures are generally limited to a single biological system. This paper describes the design, rationale and feasibility of a study to simultaneously measure neuroendocrine, immune and autonomic nervous system (ANS responses to psychological and physiological stressors in relation to ELS. Five healthy university students were recruited by advertisement. Exclusion criteria included chronic medical conditions, psychotic disorders, needle phobia, inability to tolerate pain, and those using anti-inflammatory medications. They were clinically interviewed and physiological recordings made over a two-hour period pre, during and post two acute stressors: the cold pressor test and recalling a distressing memory. The Childhood Trauma Questionnaire and the Parental Bonding Index were utilised to measure ELS. Other psychological measures of mood and personality were also administered. Measurements of heart rate, blood pressure, respiratory rate, skin conductance, skin blood flow and temporal plasma samples were successfully obtained before, during and after acute stress. Participants reported the extensive psychological and multisystem physiological data collection and stress provocations were tolerable. Most (4/5 participants indicated a willingness to return to repeat the protocol, indicating acceptability. Our protocol is viable and safe in young physically healthy adults and allows us to assess simultaneously neuroendocrine, immune and autonomic nervous system responses to stressors in persons assessed for ELS. Keywords: Childhood-stress, Adverse-childhood-events, Childhood-trauma questionnaire, Parental-bonding-instrument, Type D scale (DS14

The Action to Control Cardiovascular Risk in Diabetes Memory in Diabetes Study (ACCORD-MIND): rationale, design, and methods.

Science.gov (United States)

Williamson, Jeff D; Miller, Michael E; Bryan, R Nick; Lazar, Ronald M; Coker, Laura H; Johnson, Janice; Cukierman, Tali; Horowitz, Karen R; Murray, Anne; Launer, Lenore J

2007-06-18

Type 2 diabetes mellitus and cognitive impairment are 2 of the most common chronic conditions found in persons aged > or = 60 years. Clinical studies have shown a greater prevalence of global cognitive impairment, incidence of cognitive decline, and incidence of Alzheimer disease in patients with type 2 diabetes. To date, there have been no randomized trials of the effects of long-term glycemic control on cognitive function and structural brain changes in patients with type 2 diabetes. The primary aim of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Memory in Diabetes Study (ACCORD-MIND) is to test whether there is a difference in the rate of cognitive decline and structural brain change in patients with diabetes treated with standard-care guidelines compared with those treated with intensive-care guidelines. This comparison will be made in a subsample of 2,977 patients with diabetes participating in the ongoing ACCORD trial, a clinical trial sponsored by the National Heart, Lung, and Blood Institute (NHLBI) with support from the National Institute on Aging (NIA). Data from this ACCORD substudy on the possible beneficial or adverse effects of intensive treatment on cognitive function will be obtained from a 30-minute test battery, administered at baseline and 20-month and 40-month visits. In addition, full-brain magnetic resonance imaging will be performed on 630 participants at baseline and at 40 months to assess the relation between the ACCORD treatments and structural brain changes. The general aim of ACCORD-MIND is to determine whether the intensive treatment of diabetes, a major risk factor for Alzheimer disease and vascular dementia, can reduce the early decline in cognitive function that could later evolve into more cognitively disabling conditions. This report presents the design, rationale, and methods of the ACCORD-MIND substudy.

Readiness for diabetes prevention and barriers to lifestyle change in women with a history of gestational diabetes mellitus: rationale and study design.

Science.gov (United States)

Lipscombe, Lorraine L; Banerjee, Ananya Tina; McTavish, Sarah; Mukerji, Geetha; Lowe, Julia; Ray, Joel; Evans, Marilyn; Feig, Denice S

2014-10-01

Women with gestational diabetes mellitus (GDM) have a high risk of future diabetes, which can be prevented with lifestyle modification. Prior diabetes prevention programmes in this population have been limited by lack of adherence. The aim of this study is to evaluate readiness for behaviour change at different time points after GDM diagnosis and identify barriers and facilitators, to inform a lifestyle modification programme specifically designed for this group. The objective of this paper is to present the rationale and methodological design of this study. The ongoing prospective cohort study has recruited a multi-ethnic cohort of 1353 women with GDM from 7 Ontario, Canada hospitals during their pregnancy. A questionnaire was developed to evaluate stage of readiness for behaviour change, and sociodemographic, psychosocial, and clinical predictors of healthy diet and physical activity. Thus far, 960 women (71%) have completed a baseline survey prior to delivery. Prospective postpartum follow-up is ongoing. We are surveying women at 2 time-points after delivery: 3-12 months postpartum, and 13-24 months postpartum. Survey data will be linked to health care administrative databases for long-term follow-up for diabetes. Qualitative interviews were conducted in a subset of women to gain a deeper understanding of barriers and facilitators to lifestyle change. Our study is a fundamental first step in effectively addressing diabetes prevention in women with GDM. Our findings will aid in the design of a diabetes prevention intervention specifically targeted to women with recent GDM, which can then be evaluated in a clinical trial. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

The National Patient-Centered Clinical Research Network (PCORnet) Bariatric Study Cohort: Rationale, Methods, and Baseline Characteristics

Science.gov (United States)

Rasmussen-Torvik, Laura J; Harmata, Emily E; Pardee, Roy; Saizan, Rosalinde; Malanga, Elisha; Sturtevant, Jessica L; Horgan, Casie E; Anau, Jane; Janning, Cheri D; Wellman, Robert D; Coley, R Yates; Cook, Andrea J; Courcoulas, Anita P; Coleman, Karen J; Williams, Neely A; McTigue, Kathleen M; Arterburn, David; McClay, James

2017-01-01

Background Although bariatric procedures are commonly performed in clinical practice, long-term data on the comparative effectiveness and safety of different procedures on sustained weight loss, comorbidities, and adverse effects are limited, especially in important patient subgroups (eg, individuals with diabetes, older patients, adolescents, and minority patients). Objective The objective of this study was to create a population-based cohort of patients who underwent 3 commonly performed bariatric procedures—adjustable gastric band (AGB), Roux-en-Y gastric bypass (RYGB), and sleeve gastrectomy (SG)—to examine the long-term comparative effectiveness and safety of these procedures in both adults and adolescents. Methods We identified adults (20 to 79 years old) and adolescents (12 to 19 years old) who underwent a primary (first observed) AGB, RYGB, or SG procedure between January 1, 2005 and September 30, 2015 from 42 health systems participating in the Clinical Data Research Networks within the National Patient-Centered Clinical Research Network (PCORnet). We extracted information on patient demographics, encounters with healthcare providers, diagnoses recorded and procedures performed during these encounters, vital signs, and laboratory test results from patients’ electronic health records (EHRs). The outcomes of interest included weight change, incidence of major surgery-related adverse events, and diabetes remission and relapse, collected for up to 10 years after the initial bariatric procedure. Results A total of 65,093 adults and 777 adolescents met the eligibility criteria of the study. The adult subcohort had a mean age of 45 years and was predominantly female (79.30%, 51,619/65,093). Among adult patients with non-missing race or ethnicity information, 72.08% (41,248/57,227) were White, 21.13% (12,094/57,227) were Black, and 20.58% (13,094/63,637) were Hispanic. The average highest body mass index (BMI) recorded in the year prior to surgery was 49 kg

Ethical implications of co-benefits rationale within climate change mitigation strategy

Directory of Open Access Journals (Sweden)

Rita Vasconcellos Oliveira

2016-10-01

Full Text Available Climate change mitigation effort is being translated into several actions and discourses that make collateral benefits and their rationale increasingly relevant for sustainability, in such a way that they are now a constant part of the political agenda. Taking a border and consensual perspective, co-benefits are considered here to be emerging advantages of the implementation of measures regarding the lowering of greenhouse gases.Departing from the analysis of policy documents referring to two European urban transportation strategies, the emergent co-benefits are problematized and discussed to better understand their moral aspect. Further ethical reflection is conducted after an analysis of some unintended consequences of co-benefits rationale coming from the mentioned examples. The focus is primarily on the challenges of an integrative moral justification for co-benefits and also for their role in the climate change mitigation effort. We also discuss the limitations of the current normative models that frame co-benefits rationale, from a moral viewpoint and in relation to the overall climate change mitigation strategy.In this article, we propose the concepts of well-being and freedom, as portrayed by Capabilities Approach, as possible guiding notions for the moral and social evaluation of goodness of these emergent benefits and their rationale too. Additionally, some preliminary conclusions are drawn regarding the potential of the presented concepts to favour the climate change mitigation action. Finally, a scenario is drawn where Capabilities Approach is the moral guideline for co-benefits rationale showing this way its potential in terms of enhancing climate change mitigation strategy.

Toxic clinical hypoxic radiation sensitizers plus radiation-induced toxicity

International Nuclear Information System (INIS)

Richmond, R.C.

1984-01-01

The operational definition espoused twelve years ago that clinical hypoxic radiation sensitizers should be nontoxic interferes with the recognition and research of useful radiation sensitizers. Eight years ago the toxic antitumor drug cis-dichlorodiammineplatinum(II) was reported to be a hypoxic radiation sensitizer and the selective antitumor action of this drug was stressed as potentially creating tumor-targeted radiation sensitization. This rationale of oxidative antitumor drugs as toxic and targeted clinical sensitizers is useful, and has led to the study reported here. The antitumor drug cis-(1,1-cyclobutane-dicarboxylato)diammineplatinum(II), or JM-8, is being tested in clinical trials. Cells of S. typhimurium in PBS in the presence of 0.2mM JM-8 are found to be sensitized to irradiation under hypoxic, but not oxic, conditions. JM-8 is nontoxic to bacteria at this concentration, but upon irradiation the JM-8 solution becomes highly toxic. This radiation induced toxicity of JM-8 preferentially develops from hypoxic solution, and thus contributes to the rationale of hypoxic tumor cell destruction

The rationale for energy efficiency policy: Assessing the recognition of the multiple benefits of energy efficiency retrofit policy

International Nuclear Information System (INIS)

Kerr, Niall; Gouldson, Andy; Barrett, John

2017-01-01

The rationale for energy efficiency policy can be framed in terms of a variety of different benefits. This paper considers how different benefits have been used within the overall rationale for energy efficient retrofit policy in different contexts. We posit that different rationales may be used for the same policy response, and that the form of rationale used may affect the design, delivery or the level of policy support, with different rationales making it easier to account for different results. Considering retrofit policy in the contexts of the UK, Germany, New Zealand and Ireland, we characterise policy rationale in each case, assessing what the key perceived benefits have been, and whether they have changed over time. The analysis identifies some marked differences between cases with the recognition of benefits and the ensuing policy rationale resulting from a complex mix of political, social and economic influences. We find that recognition of multiple benefits may not equate with multiplied policy support, and instead it is more likely that different rationales will have relevance at different times, for different audiences. The findings highlight that, alongside evidence for policy, it is important to also consider how the overall rationale for policy is eventually framed. - Highlights: • Energy efficiency as a policy issue with perceived multiple benefits. • Assessment of the influence of different benefits on rationale for energy efficient retrofit policy. • How does the rationale for retrofit policy differ in different national policy contexts. • To what extent are the perceived multiple benefits of policy recognised. • What influence does eventual rationale for policy have on the policy implemented.

Using design rationale to improve SPL traceability

NARCIS (Netherlands)

Galvao, I.; Aksit, Mehmet; van den Broek, P.M.; Hendriks, M.F.H.; Rashid, Awais; Royer, Jean-Claude; Rummler, Andreas

In order to improve SPL traceability by using design rationale, this chapter introduces the traceability analysis framework (TAF), which, when combined with the AMPLE Traceability Framework, provides extra traceability capabilities for variability management. The TAF is a programmable and extensible

International Study to Predict Optimized Treatment for Depression (iSPOT-D, a randomized clinical trial: rationale and protocol

Directory of Open Access Journals (Sweden)

Cooper Nicholas J

2011-01-01

Full Text Available Abstract Background Clinically useful treatment moderators of Major Depressive Disorder (MDD have not yet been identified, though some baseline predictors of treatment outcome have been proposed. The aim of iSPOT-D is to identify pretreatment measures that predict or moderate MDD treatment response or remission to escitalopram, sertraline or venlafaxine; and develop a model that incorporates multiple predictors and moderators. Methods/Design The International Study to Predict Optimized Treatment - in Depression (iSPOT-D is a multi-centre, international, randomized, prospective, open-label trial. It is enrolling 2016 MDD outpatients (ages 18-65 from primary or specialty care practices (672 per treatment arm; 672 age-, sex- and education-matched healthy controls. Study-eligible patients are antidepressant medication (ADM naïve or willing to undergo a one-week wash-out of any non-protocol ADM, and cannot have had an inadequate response to protocol ADM. Baseline assessments include symptoms; distress; daily function; cognitive performance; electroencephalogram and event-related potentials; heart rate and genetic measures. A subset of these baseline assessments are repeated after eight weeks of treatment. Outcomes include the 17-item Hamilton Rating Scale for Depression (primary and self-reported depressive symptoms, social functioning, quality of life, emotional regulation, and side-effect burden (secondary. Participants may then enter a naturalistic telephone follow-up at weeks 12, 16, 24 and 52. The first half of the sample will be used to identify potential predictors and moderators, and the second half to replicate and confirm. Discussion First enrolment was in December 2008, and is ongoing. iSPOT-D evaluates clinical and biological predictors of treatment response in the largest known sample of MDD collected worldwide. Trial registration International Study to Predict Optimised Treatment - in Depression (iSPOT-D ClinicalTrials.gov Identifier

Impact of delay in clinical presentation on the diagnostic management and prognosis of patients with suspected pulmonary embolism

NARCIS (Netherlands)

Den Exter, Paul L.; Van Es, Josien; Erkens, Petra M.G.; Van Roosmalen, Mark J.G.; Van Den Hoven, Pim; Hovens, Marcel M.C.; Kamphuisen, Pieter W.; Klok, Frederikus A.; Huisman, Menno V.

2013-01-01

Rationale: The nonspecific clinical presentation of pulmonary embolism (PE) frequently leads to delay in its diagnosis. Objectives: This study aimed to assess the impact of delay in presentation on the diagnostic management and clinical outcome of patients with suspected PE. Methods: In 4,044

Cognitive rehabilitation: the role of theoretical rationales and respect for the maturational process needed for our evidence.

Science.gov (United States)

Gonzalez-Rothi, Leslie J

2006-01-01

The challenge to presenters at the Galveston Brain Injury Conference held in April 2005 was to discuss examples of the use of theory to motivate the design of treatments for cognitive deficits resulting from traumatic brain injury. This article considers the role of theoretical rationales as well as the new optimism embracing neurorehabilitation today. However, caution to respect the maturational process needed to adequately prepare treatment evidence for clinical application is affected.

Blood irradiation: Rationale and technique

International Nuclear Information System (INIS)

Lewis, M.C.

1990-01-01

Upon request by the local American Red Cross, the Savannah Regional Center for Cancer Care irradiates whole blood or blood components to prevent post-transfusion graft-versus-host reaction in patients who have severely depressed immune systems. The rationale for blood irradiation, the total absorbed dose, the type of patients who require irradiated blood, and the regulations that apply to irradiated blood are presented. A method of irradiating blood using a linear accelerator is described

Rationale and design of the DARWIN-T2D (DApagliflozin Real World evIdeNce in Type 2 Diabetes): A multicenter retrospective nationwide Italian study and crowdsourcing opportunity.

Science.gov (United States)

Fadini, G P; Zatti, G; Consoli, A; Bonora, E; Sesti, G; Avogaro, A

2017-12-01

Randomized controlled trials (RCTs) in the field of diabetes have limitations inherent to the fact that design, setting, and patient characteristics may be poorly transferrable to clinical practice. Thus, evidence from studies using routinely accumulated clinical data are increasingly valued. We herein describe rationale and design of the DARWIN-T2D (DApagliflozin Real World evIdeNce in Type 2 Diabetes), a multicenter retrospective nationwide study conducted at 50 specialist outpatient clinics in Italy and promoted by the Italian Diabetes Society. The primary objective of the study is to describe the baseline clinical characteristics (particularly HbA1c) of patients initiated on dapagliflozin from marketing authorization approval to the end of 2016. Secondary and exploratory objectives will evaluate the changes in glycaemic and extraglycaemic efficacy parameters after initiation of dapagliflozin or after initiation of comparator glucose lowering medications (DPP-4 inhibitors, gliclazide extended release, and long-acting GLP-1 receptor agonists). An automated software will extract relevant data from the same electronic chart system at all centres, thereby minimizing data treatment and human intervention. The study is expected to collect an enormous dataset of information on dapagliflozin- and comparator-using patients. After study completion, the Italian Diabetes Society will launch an open crowdsourcing call on the DARWIN-T2D database, challenging diabetes researchers to apply their ideas and approaches to address new unmet needs and knowledge gaps in diabetes. We believe this will move DARWIN-T2D to the next generation of real world studies. Copyright © 2017 The Italian Society of Diabetology, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition, and the Department of Clinical Medicine and Surgery, Federico II University. Published by Elsevier B.V. All rights reserved.

Explaining clinical behaviors using multiple theoretical models

OpenAIRE

Eccles, Martin P; Grimshaw, Jeremy M; MacLennan, Graeme; Bonetti, Debbie; Glidewell, Liz; Pitts, Nigel B; Steen, Nick; Thomas, Ruth; Walker, Anne; Johnston, Marie

2012-01-01

Abstract Background In the field of implementation research, there is an increased interest in use of theory when designing implementation research studies involving behavior change. In 2003, we initiated a series of five studies to establish a scientific rationale for interventions to translate research findings into clinical practice by exploring the performance of a number of different, commonly used, overlapping behavioral theories and models. We reflect on the strengths and weaknesses of...

Apixaban for treatment of embolic stroke of undetermined source (ATTICUS randomized trial): Rationale and study design.

Science.gov (United States)

Geisler, Tobias; Poli, Sven; Meisner, Christoph; Schreieck, Juergen; Zuern, Christine S; Nägele, Thomas; Brachmann, Johannes; Jung, Werner; Gahn, Georg; Schmid, Elisabeth; Bäezner, Hansjörg; Keller, Timea; Petzold, Gabor C; Schrickel, Jan-Wilko; Liman, Jan; Wachter, Rolf; Schön, Frauke; Schabet, Martin; Lindner, Alfred; Ludolph, Albert C; Kimmig, Hubert; Jander, Sebastian; Schlegel, Uwe; Gawaz, Meinrad; Ziemann, Ulf

2017-12-01

Rationale Optimal secondary prevention of embolic stroke of undetermined source is not established. The current standard in these patients is acetylsalicylic acid, despite high prevalence of yet undetected paroxysmal atrial fibrillation. Aim The ATTICUS randomized trial is designed to determine whether the factor Xa inhibitor apixaban administered within 7 days after embolic stroke of undetermined source, is superior to acetylsalicylic acid for prevention of new ischemic lesions documented by brain magnetic resonance imaging within 12 months after index stroke. Design Prospective, randomized, blinded, parallel-group, open-label, German multicenter phase III trial in approximately 500 patients with embolic stroke of undetermined source. A key inclusion criterion is the presence or the planned implantation of an insertable cardiac monitor. Patients are 1:1 randomized to apixaban or acetylsalicylic acid and treated for a 12-month period. It is an event-driven trial aiming for core-lab adjudicated primary outcome events. Study outcomes The primary outcome is the occurrence of at least one new ischemic lesion identified by axial T2-weighted FLAIR magnetic resonance imaging and/or axial DWI magnetic resonance imaging at 12 months when compared with the baseline magnetic resonance imaging. Key secondary outcomes are the combination of recurrent ischemic strokes, hemorrhagic strokes, systemic embolism; combination of MACE including recurrent stroke, myocardial infarction, and cardiovascular death and combination of major and clinically relevant non-major bleeding defined according to ISTH, and change of cognitive function and quality of life (EQ-5D, Stroke Impact Scale). Discussion Embolic stroke of undetermined source is caused by embolic disease and associated with a high risk of recurrent ischemic strokes and clinically silent cerebral ischemic lesions. ATTICUS will investigate the impact of atrial fibrillation detected by insertable cardiac monitor and the effects of

Den danske udgave af Structured Clinical Interview for DSM-5 Personality Disorders (SCID-5-PD)

DEFF Research Database (Denmark)

Kongerslev, Mickey T; Bach, Bo; Olsen, Cecilie Westergaard

2017-01-01

The chapter outlines the rationale for using structured clinical interviews to diagnose personality disorder, provides an overview of the changes from SCID-II to SCID-5-PD, and describes the translation procedures used for the Danish version......The chapter outlines the rationale for using structured clinical interviews to diagnose personality disorder, provides an overview of the changes from SCID-II to SCID-5-PD, and describes the translation procedures used for the Danish version...

Aspirin for the prevention of cognitive decline in the elderly: rationale and design of a neuro-vascular imaging study (ENVIS-ion

Directory of Open Access Journals (Sweden)

Reid Christopher M

2012-02-01

Full Text Available Abstract Background This paper describes the rationale and design of the ENVIS-ion Study, which aims to determine whether low-dose aspirin reduces the development of white matter hyper-intense (WMH lesions and silent brain infarction (SBI. Additional aims include determining whether a changes in retinal vascular imaging (RVI parameters parallel changes in brain magnetic resonance imaging (MRI; b changes in RVI parameters are observed with aspirin therapy; c baseline cognitive function correlates with MRI and RVI parameters; d changes in cognitive function correlate with changes in brain MRI and RVI and e whether factors such as age, gender or blood pressure influence the above associations. Methods/Design Double-blind, placebo-controlled trial of three years duration set in two Australian academic medical centre outpatient clinics. This study will enrol 600 adults aged 70 years and over with normal cognitive function and without overt cardiovascular disease. Subjects will undergo cognitive testing, brain MRI and RVI at baseline and after 3 years of study treatment. All subjects will be recruited from a 19,000-patient clinical outcome trial conducted in Australia and the United States that will evaluate the effects of aspirin in maintaining disability-free longevity over 5 years. The intervention will be aspirin 100 mg daily versus matching placebo, randomized on a 1:1 basis. Discussion This study will improve understanding of the mechanisms at the level of brain and vascular structure that underlie the effects of aspirin on cognitive function. Given the limited access and high cost of MRI, RVI may prove useful as a tool for the identification of individuals at high risk for the development of cerebrovascular disease and cognitive decline. Trial Registration clinicaltrials.gov Identifier: NCT01038583

Cost-effectiveness of home telemonitoring in chronic kidney disease patients at different stages by a pragmatic randomized controlled trial (eNephro): rationale and study design.

Science.gov (United States)

Thilly, Nathalie; Chanliau, Jacques; Frimat, Luc; Combe, Christian; Merville, Pierre; Chauveau, Philippe; Bataille, Pierre; Azar, Raymond; Laplaud, David; Noël, Christian; Kessler, Michèle

2017-04-05

Home telemonitoring has developed considerably over recent years in chronic diseases in order to improve communication between healthcare professionals and patients and to promote early detection of deteriorating health status. In the nephrology setting, home telemonitoring has been evaluated in home dialysis patients but data are scarce concerning chronic kidney disease (CKD) patients before and after renal replacement therapy. The eNephro study is designed to assess the cost effectiveness, clinical/biological impact, and patient perception of a home telemonitoring for CKD patients. Our purpose is to present the rationale, design and organisational aspects of this study. eNephro is a pragmatic randomised controlled trial, comparing home telemonitoring versus usual care in three populations of CKD patients: stage 3B/4 (n = 320); stage 5D CKD on dialysis (n = 260); stage 5 T CKD treated with transplantation (n= 260). Five hospitals and three not-for-profit providers managing self-care dialysis situated in three administrative regions in France are participating. The trial began in December 2015, with a scheduled 12-month inclusion period and 12 months follow-up. Outcomes include clinical and biological data (e.g. blood pressure, haemoglobin) collected from patient records, perceived health status (e.g. health related quality of life) collected from self-administered questionnaires, and health expenditure data retrieved from the French health insurance database (SNIIRAM) using a probabilistic matching procedure. The hypothesis is that home telemonitoring enables better control of clinical and biological parameters as well as improved perceived health status. This better control should limit emergency consultations and hospitalisations leading to decreased healthcare expenditure, compensating for the financial investment due to the telemedicine system. This study has been registered at ClinicalTrials.gov under NCT02082093 (date of registration: February 14

Rationale and clinical data supporting nutritional intervention in Alzheimer's disease.

Science.gov (United States)

Engelborghs, S; Gilles, C; Ivanoiu, A; Vandewoude, M

2014-01-01

Adequate nutrition plays an important role in the maintenance of cognitive function, particularly during aging. Malnutrition is amongst the risk factors for developing mild cognitive impairment (MCI) and Alzheimer's disease (AD). Epidemiological studies have associated deficiencies in some nutrients with a higher risk of cognitive dysfunction and/or AD. Cognitive decline in AD is correlated with synaptic loss and many of the components required to maintain optimal synaptic function are derived from dietary sources. As synapses are part of the neuronal membrane and are continuously being remodelled, the availability of sufficient levels of nutritional precursors (mainly uridine monophosphate, choline and omega-3 fatty acids) to make the phospholipids required to build neuronal membranes may have beneficial effects on synaptic degeneration in AD. In addition, B-vitamins, phospholipids and other micronutrients act as cofactors to enhance the supply of precursors required to make neuronal membranes and synapses. Despite this, no randomized controlled trial has hitherto provided evidence that any single nutrient has a beneficial effect on cognition or lowers the risk for AD. However, a multi-target approach using combinations of (micro)nutrients might have beneficial effects on cognitive function in neurodegenerative brain disorders like AD leading to synaptic degeneration. Here we review the clinical evidence for supplementation, based on a multi-target approach with a focus on key nutrients with a proposed role in synaptic dysfunction. Based on preclinical evidence, a nutrient mixture, Souvenaid(®) (Nutricia N.V., Zoetermeer, The Netherlands) was developed. Clinical trials with Souvenaid(®) have shown improved memory performance in patients with mild AD. Further clinical trials to evaluate the effects of nutritional intervention in MCI and early dementia due to AD are on-going.

Rationale and design of a large registry on renal denervation: the Global SYMPLICITY registry.

Science.gov (United States)

Böhm, Michael; Mahfoud, Felix; Ukena, Christian; Bauer, Axel; Fleck, Eckart; Hoppe, Uta C; Kintscher, Ulrich; Narkiewicz, Krzysztof; Negoita, Manuela; Ruilope, Luis; Rump, L Christian; Schlaich, Markus; Schmieder, Roland; Sievert, Horst; Weil, Joachim; Williams, Bryan; Zeymer, Uwe; Mancia, Giuseppe

2013-08-22

Hypertension is a global healthcare concern associated with a wide range of comorbidities. The recognition that elevated sympathetic drive plays an important role in the pathogenesis of hypertension led to the use of renal artery denervation to interrupt the efferent and afferent sympathetic nerves between the brain and kidneys to lower blood pressure. Clinical trials of the Symplicity™ renal denervation system have demonstrated that radiofrequency ablation of renal artery nerves is safe and significantly lowers blood pressure in patients with severe resistant (systolic BP >160 mmHg) hypertension. Smaller ancillary studies in hypertensive patients suggest a benefit from renal denervation in a variety of conditions such as chronic kidney disease, glucose intolerance, sleep apnoea and heart failure. The Global SYMPLICITY registry, which incorporates the GREAT SYMPLICITY registry initiated in Germany, is being conducted worldwide to evaluate the safety and efficacy of treatment with the Symplicity renal denervation system in real-world uncontrolled hypertensive patients, looking first at subjects with severe resistant hypertension to confirm the results of prior clinical trials, but then also subjects with a wider range of baseline blood pressure and coexisting comorbidities. The rationale, design and first baseline data from the Global SYMPLICITY registry are presented.

Public control of environmental health hazards (clinical and experimental studies of distal axonopathy--a frequent form of brain and nerve damage produced by environmental chemical hazards)

Energy Technology Data Exchange (ETDEWEB)

Schaumburg, H.H.; Spencer, P.S.

1979-01-01

Clinical and pathological studies of the peripheral and central nervous system degeneration (distal dying-back axonopathy) in humans and experimental animals produced by acrylamide monomer and certain hydrocarbon compounds are summarized. The human distal axonopathies include: many of the naturally occurring, genetically determined system disorders/ certain nutritional disorders/ uremic neuropathy/ the neuropathies associated with some malignancies/ and the toxic neuropathies induced by industrial chemicals. The irreversible, subclinical, and clinical effects of distal axonopathies on the human central nervous system are examined. A morphological rationale for previously enigmatic clinical phenomena in the human toxic neuropathies is presented. Neuropathology is potentially useful in the screening of chemicals for neurotoxicity. (7 photos, 24 references)

[Anatomic rationale for clinical efficacy of intraosseous mental nerve anesthesia].

Science.gov (United States)

Rabinovich, S A; Vasil'ev, Yu L; Kuzin, A N

2018-01-01

The aim of the study was to prove the anatomical and clinical effectiveness of the modified anesthesia of mental nerve. The effectiveness of conductive anesthesia near the mental foramen was objectively evaluated using the electric pulp test (EPT) in 100 volunteers of both sexes, aged 35-43 years. Wet anterior mandible preparations obtained from 350 cadavers aged 18-74 years were also studied. EPT value after local mental anesthesia conducted according to Malamed C. using 4% articain solution of local anesthetic with vasoconstrictor concentration of 1:200.000 after 2 minutes was 93±0.82 mA, after 4 minutes - 188±1.26 mA. Yield variability indicators of intraosseous mental nerve anesthesia was slightly higher varying from 94.11 mA to 96.61 mA after 2 minutes and from 197.4 to 199.92 mA after 4 minutes survey. The study showed the efficiency and predictability of intraosseous anesthesia of the mental nerve.

Rationale, design and baseline results of the Treatment Optimisation in Primary care of Heart failure in the Utrecht region (TOPHU) study : a cluster randomised controlled trial

NARCIS (Netherlands)

Valk, Mark J.; Hoes, Arno W.; Mosterd, Arend; Landman, Marcel A.; Broekhuizen, Berna D L; Rutten, Frans H.

2015-01-01

BACKGROUND: Heart failure (HF) is mainly detected and managed in primary care, but the care is considered suboptimal. We present the rationale, design and baseline results of the Treatment Optimisation in Primary care of Heart failure in the Utrecht region (TOPHU) study. In this study we assess the

Managed ventricular pacing vs. conventional dual-chamber pacing for elective replacements: the PreFER MVP study: clinical background, rationale, and design.

Science.gov (United States)

Quesada, Aurelio; Botto, Gianluca; Erdogan, Ali; Kozak, Milan; Lercher, Peter; Nielsen, Jens Cosedis; Piot, Olivier; Ricci, Renato; Weiss, Christian; Becker, Daniel; Wetzels, Gwenn; De Roy, Luc

2008-03-01

Several clinical studies have shown that, in patients with intact atrioventricular (AV) conduction, unnecessary chronic right ventricular (RV) pacing can be detrimental. The managed ventricular pacing (MVP) algorithm is designed to give preference to spontaneous AV conduction, thus minimizing RV pacing. The clinical outcomes of MVP are being studied in several ongoing trials in patients undergoing a first device implantation, but it is unknown to what extent MVP is beneficial in patients with a history of ventricular pacing. The purpose of the Prefer for Elective Replacement MVP (PreFER MVP) study is to assess the superiority of the MVP algorithm to conventional pacemaker and implantable cardioverter-defibrillator programming in terms of freedom from hospitalization for cardiovascular causes in a population of patients exposed to long periods of ventricular pacing. PreFER MVP is a prospective, 1:1 parallel, randomized (MVP ON/MVP OFF), single-blinded multi-centre trial. The study population consists of patients with more than 40% ventricular pacing documented with their previous device. Approximately, 600 patients will be randomized and followed for at least 24 months. The primary endpoint comprises cardiovascular hospitalization. The PreFER MVP trial is the first large prospective randomized clinical trial evaluating the effect of MVP in patients with a history of RV pacing.

Adapting clinical guidelines in low-resources countries : a study on the guideline on the management and prevention of type 2 diabetes mellitus in Indonesia

NARCIS (Netherlands)

Widyahening, Indah S.; Wangge, Grace; van der Graaf, Yolanda; van der Heijden, Geert J M G

2017-01-01

Rationale, aims and objectives: Most of the clinical guidelines in low-resource countries are adaptations from preexisting international guidelines. This adaptation can be problematic when those international guidelines are not based on current evidence or original evidence-based international

Organ Donation in the 50+ Age Demographic: Survey Results on Decision Rationale and Information Preferences.

Science.gov (United States)

Tartaglia, Alexander; Dodd-McCue, Diane; Myer, Kevin A; Mullins, Andrew

2016-09-01

The rate of organ donation by older potential donors is significantly declining even though recent studies show positive clinical outcomes with organs transplanted from older donors. This study examined the 50+ age demographic to identify the rationale for donation decisions, preferred media methods of donation information delivery, and responsiveness to an age-tailored donation message. Results from 579 surveys, 87% from the 50+ age demographic, found respondents prone to self-select themselves as medically ineligible based on current medication and health status, even though they might be medically suitable donors. Their incentive to pursue additional information on donation is limited except when motivated by personal accounts within their families and communities. In addition, even when computer literate, they continue to favor the printed or spoken word for donation information delivery. The results suggest an opportunity for those working with older adults to develop more personalized, localized donation education programs targeting this age demographic. © The Author(s) 2014.

Learning Rationales and Virtual Reality Technology in Education.

Science.gov (United States)

Chiou, Guey-Fa

1995-01-01

Defines and describes virtual reality technology and differentiates between virtual learning environment, learning material, and learning tools. Links learning rationales to virtual reality technology to pave conceptual foundations for application of virtual reality technology education. Constructivism, case-based learning, problem-based learning,…

Rationale and Design of the Women and Inclusion in Academic Medicine Study.

Science.gov (United States)

Hill, Emorcia V; Wake, Michael; Carapinha, René; Normand, Sharon-Lise; Wolf, Robert E; Norris, Keith; Reede, Joan Y

2016-04-21

Women of color (WOC) (African American, Hispanic, Native American/Alaskan Native, and Asian American) faculty remain disproportionately underrepresented among medical school faculty and especially at senior ranks compared with White female faculty. The barriers or facilitators to the career advancement of WOC are poorly understood. The Women and Inclusion in Academic Medicine (WIAM) study was developed to characterize individual, institutional and sociocultural factors that influence the entry, progression and persistence, and advancement of women faculty in academic medical careers with a focus on WOC. Using a purposive sample of 13 academic medical institutions, we collected qualitative interview data from 21 WOC junior faculty and quantitative data from 3,127 (38.9% of 8,053 eligible women) respondents via an online survey. To gather institutional data, we used an online survey and conducted 23 key administrative informant interviews from the 13 institutions. Grounded theory methodology will be used to analyze qualitative data. Multivariable analysis including hierarchical linear modeling will be used to investigate outcomes, such as the inclusiveness of organizational gender climate and women faculty's intent to stay. We describe the design, methods, rationale and limitations of one of the largest and most comprehensive studies of women faculty in academic medicine with a focus on WOC. This study will enhance our understanding of challenges that face women, and, especially WOC, faculty in academic medicine and will provide solutions at both the individual and institutional levels.

The anti-interleukin-1 in type 1 diabetes action trial--background and rationale

DEFF Research Database (Denmark)

Pickersgill, Linda M S; Mandrup-Poulsen, Thomas R

2009-01-01

Type 1 diabetes (T1D) is caused by an inflammatory destruction of pancreatic beta-cells. Pro-inflammatory cytokines, in particular interleukin-1 (IL-1), have been suggested to be effector molecules based on the observations that pro-inflammatory cytokines cause beta-cell apoptosis in vitro...... and aggravate diabetes in vivo, and that inhibition of the action of these cytokines reduce diabetes incidence in animal models of type 1 diabetes and islet graft destruction. This review presents the rationale for and design of a recently launched double-blind, multicenter, randomized clinical trial...... that investigates the effect of interleukin-1 antagonism on beta-cell function in subjects with T1D of recent-onset....

Reregulation of the Swedish pharmacy sector-A qualitative content analysis of the political rationale.

Science.gov (United States)

Wisell, Kristin; Winblad, Ulrika; Sporrong, Sofia Kälvemark

2015-05-01

In 2009, a reregulation of the Swedish pharmacy sector took place, and a fundamental change in ownership and structure followed. The reregulation provides an opportunity to reveal the politicians' views on pharmacies. The aim of this study was to explore and analyze the political arguments for the reregulation of the Swedish pharmacy sector in 2009. The method used was a qualitative content analysis of written political documents regarding the reregulation. The primary rationales for the reregulation were better availability, efficiency, price pressure, and safe usage of medicines. During the preparatory work, the rationales of diversity on the market and entrepreneurship were added, while the original rationales of efficiency, price pressure, and better usage of medicines were abandoned. The reform can be seen as a typical New Public Management reform influenced by the notion that private actors are better equipped to perform public activities. The results point to that the reform was done almost solely in order to introduce private ownership in the pharmacy sector, and was not initiated in order to solve any general problems, or to enhance patient outcomes of medicine use. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Nondamaging Retinal Laser Therapy: Rationale and Applications to the Macula.

Science.gov (United States)

Lavinsky, Daniel; Wang, Jenny; Huie, Philip; Dalal, Roopa; Lee, Seung Jun; Lee, Dae Yeong; Palanker, Daniel

2016-05-01

Retinal photocoagulation and nondamaging laser therapy are used for treatment of macular disorders, without understanding of the response mechanism and with no rationale for dosimetry. To establish a proper titration algorithm, we measured the range of tissue response and damage threshold. We then evaluated safety and efficacy of nondamaging retinal therapy (NRT) based on this algorithm for chronic central serous chorioretinopathy (CSCR) and macular telangiectasia (MacTel). Retinal response to laser treatment below damage threshold was assessed in pigmented rabbits by expression of the heat shock protein HSP70 and glial fibrillary acidic protein (GFAP). Energy was adjusted relative to visible titration using the Endpoint Management (EpM) algorithm. In clinical studies, 21 eyes with CSCR and 10 eyes with MacTel were treated at 30% EpM energy with high spot density (0.25-diameter spacing). Visual acuity, retinal and choroidal thickness, and subretinal fluid were monitored for 1 year. At 25% EpM energy and higher, HSP70 was expressed acutely in RPE, and GFAP upregulation in Müller cells was observed at 1 month. Damage appeared starting at 40% setting. Subretinal fluid resolved completely in 81% and partially in 19% of the CSCR patients, and visual acuity improved by 12 ± 3 letters. Lacunae in the majority of MacTel patients decreased while preserving the retinal thickness, and vision improved by 10 letters. Heat shock protein expression in response to hyperthermia helps define the therapeutic window for NRT. Lack of tissue damage enables high-density treatment to boost clinical efficacy, therapy in the fovea, and retreatments to manage chronic diseases.

An ecological dynamics rationale to explain home advantage in professional football

Science.gov (United States)

Gama, José; Dias, Gonçalo; Couceiro, Micael; Passos, Pedro; Davids, Keith; Ribeiro, João

2016-03-01

Despite clear findings, research on home advantage in team sports lacks a comprehensive theoretical rationale for understanding why this phenomenon is so compelling. The aim of this study was to provide an explanatory theoretical rationale in ecological dynamics for the influence of home advantage observed in research on professional football. We recorded 30 competitive matches and analyzed 13958 passes, from one highly successful team in the Portuguese Premier League, during season 2010/2011. Performance data were analyzed using the Match Analysis Software—Amisco® (version 3.3.7.25), allowing us to characterize team activity profiles. Results were interpreted from an ecological dynamics perspective, explaining how task and environmental constraints of a competitive football setting required performers to continuously co-adapt to teammate behaviors. Despite slight differences in percentage of ball possession when playing home or away, the number of passes achieved by the team, while in possession of the ball, was quite different between home or away venues. When playing at home, the number of passes performed by the team was considerably higher than when playing away. The explanation proposed in this study for a home advantage effect can be understood from studying interpersonal coordination tendencies of team sports players as agents in a complex adaptive system.

DOE LLW classification rationale

International Nuclear Information System (INIS)

Flores, A.Y.

1991-01-01

This report was about the rationale which the US Department of Energy had with low-level radioactive waste (LLW) classification. It is based on the Nuclear Regulatory Commission's classification system. DOE site operators met to review the qualifications and characteristics of the classification systems. They evaluated performance objectives, developed waste classification tables, and compiled dose limits on the waste. A goal of the LLW classification system was to allow each disposal site the freedom to develop limits to radionuclide inventories and concentrations according to its own site-specific characteristics. This goal was achieved with the adoption of a performance objectives system based on a performance assessment, with site-specific environmental conditions and engineered disposal systems

Invitation to the Birthday Party: Rationale and Description

Science.gov (United States)

Ginsburg, Herbert P.; Pappas, Sandra

2016-01-01

Educators in many countries around the world have a strong interest in improving early childhood mathematics education, one component of which is formative assessment. Unlike summative assessment, this approach can provide teachers with information useful for understanding and teaching individual children. This paper describes the rationale for…

Practices and rationales of community engagement with wind farms: awareness raising, consultation, empowerment

DEFF Research Database (Denmark)

Aitken, Mhairi; Haggett, Claire; Rudolph, David Philipp

2016-01-01

In light of the growing emphasis on community engagement in the literature on renewable energy planning, and given the acknowledgement of the complexity of community engagement as a concept, we conducted an empirical review of practice relating to community engagement with onshore wind farms...... in the UK, exploring what is actually happening in terms of community engagement relating to onshore wind farms, and examining the rationales underpinning approaches to community engagement. We found that a wide range of engagement methods are being used in relation to onshore wind farms across the UK......-hierarchical classification of community engagement approaches: awareness raising; consultation and empowerment. This provides a useful tool for reflecting on practices and rationales of community engagement. By considering the three approaches non-hierarchically, this model allows for an examination of how such rationales...

Rational and irrational clinical strategies for collaborative medicine.

Science.gov (United States)

Hammerly, Milt

2002-01-01

Individual practitioners and health care systems/organizations increasingly understand the rationale for collaborative medicine. An absence of collaboration can compromise the quality and safety of patient care. But having a rationale to provide collaborative medicine without also having a rational clinical strategy can be equally compromising to the quality and safety of patient care. Reasonable evidentiary criteria must be used to determine whether specific therapies merit inclusion or exclusion in a collaborative medicine model. Ranking therapies hierarchically on the basis of their risk-benefit ratio simplifies matching of therapies with the needs of the patient. A unifying taxonomy that categorizes all therapies (complementary/alternative and conventional) on the basis of how we think they work (presumed mechanisms of action) facilitates development of a clinical strategy for collaborative medicine. On the basis of these principles, a rational clinical strategy for collaborative medicine is described to help optimize the quality and safety of patient care.

The Importance of Rationales for Internationalization at a Local Level--University and Individual

Science.gov (United States)

Willis, Ian; Taylor, John

2014-01-01

This study examines rationales for internationalization at a research intensive university in the UK. Internationalization is often described at a macro level without reaching down to explore the individual motivations that may support or constrain internationalization at a particular institution. The article argues that it is important to…

Considerations in the rationale, design and methods of the Strategic Timing of AntiRetroviral Treatment (START) study

Science.gov (United States)

Babiker, Abdel G; Emery, Sean; Fätkenheuer, Gerd; Gordin, Fred M; Grund, Birgit; Lundgren, Jens D; Neaton, James D; Pett, Sarah L; Phillips, Andrew; Touloumi, Giota; Vjecha, Michael J

2012-01-01

Background Untreated human immunodeficiency virus (HIV) infection is characterized by progressive depletion of CD4+ T lymphocyte (CD4) count leading to the development of opportunistic diseases (acquired immunodeficiency syndrome (AIDS)), and more recent data suggest that HIV is also associated with an increased risk of serious non-AIDS (SNA) diseases including cardiovascular, renal, and liver diseases and non-AIDS-defining cancers. Although combination antiretroviral treatment (ART) has resulted in a substantial decrease in morbidity and mortality in persons with HIV infection, viral eradication is not feasible with currently available drugs. The optimal time to start ART for asymptomatic HIV infection is controversial and remains one of the key unanswered questions in the clinical management of HIV-infected individuals. Purpose In this article, we outline the rationale and methods of the Strategic Timing of AntiRetroviral Treatment (START) study, an ongoing multicenter international trial designed to assess the risks and benefits of initiating ART earlier than is currently practiced. We also describe some of the challenges encountered in the design and implementation of the study and how these challenges were addressed. Methods A total of 4000 study participants who are HIV type 1 (HIV-1) infected, ART naïve with CD4 count > 500 cells/μL are to be randomly allocated in a 1:1 ratio to start ART immediately (early ART) or defer treatment until CD4 count is AIDS, SNA, or death. The study had a pilot phase to establish feasibility of accrual, which was set as the enrollment of at least 900 participants in the first year. Results Challenges encountered in the design and implementation of the study included the limited amount of data on the risk of a major component of the primary endpoint (SNA) in the study population, changes in treatment guidelines when the pilot phase was well underway, and the complexities of conducting the trial in a geographically wide

The Pediatric Obsessive-Compulsive Disorder Treatment Study II: rationale, design and methods

Directory of Open Access Journals (Sweden)

March John S

2009-01-01

Full Text Available Abstract This paper presents the rationale, design, and methods of the Pediatric Obsessive-Compulsive Disorder Treatment Study II (POTS II, which investigates two different cognitive-behavior therapy (CBT augmentation approaches in children and adolescents who have experienced a partial response to pharmacotherapy with a serotonin reuptake inhibitor for OCD. The two CBT approaches test a "single doctor" versus "dual doctor" model of service delivery. A specific goal was to develop and test an easily disseminated protocol whereby child psychiatrists would provide instructions in core CBT procedures recommended for pediatric OCD (e.g., hierarchy development, in vivo exposure homework during routine medical management of OCD (I-CBT. The conventional "dual doctor" CBT protocol consists of 14 visits over 12 weeks involving: (1 psychoeducation, (2, cognitive training, (3 mapping OCD, and (4 exposure with response prevention (EX/RP. I-CBT is a 7-session version of CBT that does not include imaginal exposure or therapist-assisted EX/RP. In this study, we compared 12 weeks of medication management (MM provided by a study psychiatrist (MM only with two types of CBT augmentation: (1 the dual doctor model (MM+CBT; and (2 the single doctor model (MM+I-CBT. The design balanced elements of an efficacy study (e.g., random assignment, independent ratings with effectiveness research aims (e.g., differences in specific SRI medications, dosages, treatment providers. The study is wrapping up recruitment of 140 youth ages 7–17 with a primary diagnosis of OCD. Independent evaluators (IEs rated participants at weeks 0,4,8, and 12 during acute treatment and at 3,6, and 12 month follow-up visits. Trial registration NCT00074815

Canadian nuclear power principles for beyond design basis events - supporting rationale

International Nuclear Information System (INIS)

Elliott, M.; Newman, G.; Bhaloo, A.

2014-01-01

The development of the following principles and their rationale began during a special Chief Nuclear Engineers forum held on March 25th, 2013 in Toronto. These principles are intended to provide guidance to the Canadian Nuclear Power Industry in developing responses to the lessons learned from the Fukushima event of March 2011. These principles were accepted and signed off by the Chief Nuclear Officers of each of the three utilities in August 2013 and were presented to the CNSC at a public hearing on August 21, 2013. This document provides the underlying rationale for the principles. (author)

Canadian nuclear power principles for beyond design basis events - supporting rationale

Energy Technology Data Exchange (ETDEWEB)

Elliott, M. [OPG Nuclear, Ontario (Canada); Newman, G. [Bruce Power, Ontario (Canada); Bhaloo, A. [New Brunswick Power, New Brunswick (Canada)

2014-09-15

The development of the following principles and their rationale began during a special Chief Nuclear Engineers forum held on March 25th, 2013 in Toronto. These principles are intended to provide guidance to the Canadian Nuclear Power Industry in developing responses to the lessons learned from the Fukushima event of March 2011. These principles were accepted and signed off by the Chief Nuclear Officers of each of the three utilities in August 2013 and were presented to the CNSC at a public hearing on August 21, 2013. This document provides the underlying rationale for the principles. (author)

Canadian nuclear power principles for beyond design basis events - supporting rationale

Energy Technology Data Exchange (ETDEWEB)

Elliott, M. [Ontario Power Generation Nuclear, Pickering, ON (Canada); Newman, G. [Bruce Power, Tiverton, ON (Canada); Bhaloo, A. [New Brunswick Power, Fredericton, NB (Canada)

2014-07-01

The development of the following principles and their rationale began during a special Chief Nuclear Engineers forum held on March 25th, 2013 in Toronto. These principles are intended to provide guidance to the Canadian Nuclear Power Industry in developing responses to the lessons learned from the Fukushima event of March 2011. These principles were accepted and signed off by the Chief Nuclear Officers of each of the three utilities in August 2013 and were presented to the CNSC at a public hearing on August 21, 2013. This document provides the underlying rationale for the principles. (author)

Rationale of Early Adopters of Fossil Fuel Divestment

Science.gov (United States)

Beer, Christopher Todd

2016-01-01

Purpose: This research uses the social science perspectives of institutions, ecological modernization and social movements to analyze the rationale used by the early-adopting universities of fossil fuel divestment in the USA. Design/methodology/approach: Through analysis of qualitative data from interviews with key actors at the universities that…

Specialization in i* strategic rationale diagrams

OpenAIRE

López Cuesta, Lidia; Franch Gutiérrez, Javier; Marco Gómez, Jordi

2012-01-01

ER 2012 Best Student Paper Award The specialization relationship is offered by the i* modeling language through the is-a construct defined over actors (a subactor is-a superactor). Although the overall meaning of this construct is highly intuitive, its semantics when it comes to the fine-grained level of strategic rationale (SR) diagrams is not defined, hampering seriously its appropriate use. In this paper we provide a formal definition of the specialization relationship at the lev...

Automating Construction of Machine Learning Models With Clinical Big Data: Proposal Rationale and Methods.

Science.gov (United States)

Luo, Gang; Stone, Bryan L; Johnson, Michael D; Tarczy-Hornoch, Peter; Wilcox, Adam B; Mooney, Sean D; Sheng, Xiaoming; Haug, Peter J; Nkoy, Flory L

2017-08-29

To improve health outcomes and cut health care costs, we often need to conduct prediction/classification using large clinical datasets (aka, clinical big data), for example, to identify high-risk patients for preventive interventions. Machine learning has been proposed as a key technology for doing this. Machine learning has won most data science competitions and could support many clinical activities, yet only 15% of hospitals use it for even limited purposes. Despite familiarity with data, health care researchers often lack machine learning expertise to directly use clinical big data, creating a hurdle in realizing value from their data. Health care researchers can work with data scientists with deep machine learning knowledge, but it takes time and effort for both parties to communicate effectively. Facing a shortage in the United States of data scientists and hiring competition from companies with deep pockets, health care systems have difficulty recruiting data scientists. Building and generalizing a machine learning model often requires hundreds to thousands of manual iterations by data scientists to select the following: (1) hyper-parameter values and complex algorithms that greatly affect model accuracy and (2) operators and periods for temporally aggregating clinical attributes (eg, whether a patient's weight kept rising in the past year). This process becomes infeasible with limited budgets. This study's goal is to enable health care researchers to directly use clinical big data, make machine learning feasible with limited budgets and data scientist resources, and realize value from data. This study will allow us to achieve the following: (1) finish developing the new software, Automated Machine Learning (Auto-ML), to automate model selection for machine learning with clinical big data and validate Auto-ML on seven benchmark modeling problems of clinical importance; (2) apply Auto-ML and novel methodology to two new modeling problems crucial for care

Oral Health Promotion in Schools: Rationale and Evaluation

Science.gov (United States)

Kizito, Alex; Caitlin, Meredith; Wang, Yili; Kasangaki, Arabat; Macnab, Andrew J.

2014-01-01

Purpose: The purpose of this paper is to explain the rationale and potential for the WHO health promoting schools (HPS) to improve children's oral health, and describe validated quantitative methodologies and qualitative approaches to measure program impact. Design/Methodology/Approach: Critical discussion of the impact of poor oral health and…

Building "Applied Linguistic Historiography": Rationale, Scope, and Methods

Science.gov (United States)

Smith, Richard

2016-01-01

In this article I argue for the establishment of "Applied Linguistic Historiography" (ALH), that is, a new domain of enquiry within applied linguistics involving a rigorous, scholarly, and self-reflexive approach to historical research. Considering issues of rationale, scope, and methods in turn, I provide reasons why ALH is needed and…

"ComPost": A Writing Program Newsletter and Its Rationale.

Science.gov (United States)

Hall, Dennis R.

1993-01-01

Discusses the development and rationale of "ComPost," a weekly newsletter of the Composition Program at the University of Louisville. Suggests that a vehicle like ComPost can promote the communications that contribute to accomplishing collegiality and genuine program consensus. (RS)

Soft Power as a Policy Rationale for International Education in the UK: A Critical Analysis

Science.gov (United States)

Lomer, Sylvie

2017-01-01

This article presents the results of a textual analysis conducted on policy discourses on international students in the UK between 1999 and 2013. A number of rationales for and against increasing their numbers have been made, which have largely remained consistent over changing political administrations. One key rationale is that international…

The PROgnostic Value of unrequested Information in Diagnostic Imaging (PROVIDI) Study: rationale and design

International Nuclear Information System (INIS)

Gondrie, M. J. A.; Mali, W. P. Th. M.; Buckens, C. F. M.; Jacobs, P. C. A.; Grobbee, D. E.; Graaf, Y van der

2010-01-01

We describe the rationale for a new study examining the prognostic value of unrequested findings in diagnostic imaging. The deployment of more advanced imaging modalities in routine care means that such findings are being detected with increasing frequency. However, as the prognostic significance of many types of unrequested findings is unknown, the optimal response to such findings remains uncertain and in many cases an overly defensive approach is adopted, to the detriment of patient-care. Additionally, novel and promising image findings that are newly available on many routine scans cannot be used to improve patient care until their prognostic value is properly determined. The PROVIDI study seeks to address these issues using an innovative multi-center case-cohort study design. PROVIDI is to consist of a series of studies investigating specific, selected disease entities and clusters. Computed Tomography images from the participating hospitals are reviewed for unrequested findings. Subsequently, this data is pooled with outcome data from a central population registry. Study populations consist of patients with endpoints relevant to the (group of) disease(s) under study along with a random control sample from the cohort. This innovative design allows PROVIDI to evaluate selected unrequested image findings for their true prognostic value in a series of manageable studies. By incorporating unrequested image findings and outcomes data relevant to patients, truly meaningful conclusions about the prognostic value of unrequested and emerging image findings can be reached and used to improve patient-care.

Sodium-glucose cotransporter 2 inhibitors combined with dipeptidyl peptidase-4 inhibitors in the management of type 2 diabetes: a review of current clinical evidence and rationale

Directory of Open Access Journals (Sweden)

Yassin SA

2017-03-01

Full Text Available Sayf A Yassin,1 Vanita R Aroda2 1MedStar Union Memorial Hospital, Baltimore, 2MedStar Health Research Institute, Hyattsville, MD, USA Abstract: Type 2 diabetes mellitus (T2DM is a progressive and multifactorial cardiometabolic disorder. Almost half of adults with diabetes fail to achieve their recommended glucose control target. This has prompted some clinicians to advocate the use of more intensive initial therapy, including the use of combination therapy to target multiple physiologic defects in diabetes with the goal of achieving and sustaining glucose control. Numerous options exist for combining the various classes of glucose-lowering agents in the treatment of T2DM. This report reviews the mechanism, rationale, and evidence from clinical trials for combining two of the newer drug classes, namely, dipeptidyl peptidase-4 inhibitors and sodium-glucose cotransporter 2 inhibitors, and considers the possible role of such dual therapy in the management of T2DM. Keywords: sodium-glucose cotransporter 2 inhibitors, dipeptidyl peptidase-4 inhibitors, type 2 diabetes mellitus, combination therapy

Clinical Studies

DEFF Research Database (Denmark)

Pallesen, Ulla

universities and practicing dentists restore millions of teeth throughout the World with composite resin materials. Do we know enough about the clinical performance of these restorations over time? Numerous in vitro studies are being published on resin materials and adhesion, some of them attempting to imitate...... in vivo conditions. But real life is different and in vitro studies cannot include all variables. Only clinical studies can provide valid information on the clinical performance of restorations over time. What do we know about longevity of posterior resin restorations? What are the reasons for replacement...... and results from own up to 30-year prospective clinical university studies and practice based studies from Public Dental Health Service on the clinical performance of posterior composite resin restorations....

Clinical investigations of the therapeutic potential of ayahuasca: rationale and regulatory challenges.

Science.gov (United States)

McKenna, Dennis J

2004-05-01

Ayahuasca is a hallucinogenic beverage that is prominent in the ethnomedicine and shamanism of indigenous Amazonian tribes. Its unique pharmacology depends on the oral activity of the hallucinogen, N,N-dimethyltryptamine (DMT), which results from inhibition of monoamine oxidase (MAO) by beta-carboline alkaloids. MAO is the enzyme that normally degrades DMT in the liver and gut. Ayahuasca has long been integrated into mestizo folk medicine in the northwest Amazon. In Brazil, it is used as a sacrament by several syncretic churches. Some of these organizations have incorporated in the United States. The recreational and religious use of ayahuasca in the United States, as well as "ayahuasca tourism" in the Amazon, is increasing. The current legal status of ayahuasca or its source plants in the United States is unclear, although DMT is a Schedule I controlled substance. One ayahuasca church has received favorable rulings in 2 federal courts in response to its petition to the Department of Justice for the right to use ayahuasca under the Religious Freedom Restoration Act. A biomedical study of one of the churches, the Uñiao do Vegetal (UDV), indicated that ayahuasca may have therapeutic applications for the treatment of alcoholism, substance abuse, and possibly other disorders. Clinical studies conducted in Spain have demonstrated that ayahuasca can be used safely in normal healthy adults, but have done little to clarify its potential therapeutic uses. Because of ayahuasca's ill-defined legal status and variable botanical and chemical composition, clinical investigations in the United States, ideally under an approved Investigational New Drug (IND) protocol, are complicated by both regulatory and methodological issues. This article provides an overview of ayahuasca and discusses some of the challenges that must be overcome before it can be clinically investigated in the United States.

Randomized controlled trial to evaluate the effect of canola oil on blood vessel function in peripheral arterial disease: rationale and design of the Canola-PAD Study

Directory of Open Access Journals (Sweden)

Enns JE

2014-10-01

Full Text Available Jennifer E Enns,1,2 Peter Zahradka,1–3 Randolph P Guzman,4,5 Alanna Baldwin,1 Brendon Foot,1 Carla G Taylor1–31Canadian Centre for Agri-Food Research in Health and Medicine, St Boniface Research Centre, Winnipeg, Canada; 2Department of Physiology, University of Manitoba, Winnipeg, Manitoba, Canada; 3Department of Human Nutritional Sciences, University of Manitoba, Winnipeg, Manitoba, Canada; 4IH Asper Clinical Research Institute, St Boniface Hospital, Winnipeg, Canada; 5Section of Vascular Surgery, Department of Surgery, St Boniface Hospital, Winnipeg, CanadaBackground: Individuals with peripheral arterial disease (PAD are at high risk for cardiac events due to atherosclerosis. Dietary fatty acid composition has been shown to modulate blood vessel properties, but whether a diet enriched in conventional canola oil can improve clinical endpoints in PAD is not known.Purpose: To describe the rationale and design of a clinical trial testing the effect of canola oil consumption on vascular function and cardiovascular risk factors in an 8-week dietary intervention in individuals with PAD.Methods: The Canola-PAD Study was a single center, prospective, double-blind, randomized controlled trial in 50 patients over 40 years old with PAD. Participants were randomized into two groups and consumed food items containing either conventional canola oil (25 g/day or an oil mixture representing the Western diet (25 g/day for 8 weeks as part of their usual diet. The primary outcome was vascular function (ankle-brachial index, arterial stiffness, endothelial dysfunction, walking capacity, and cognitive function. Secondary measurements included anthropometrics, serum lipid profile and fatty acid composition, markers of inflammation and glycemic control, and serum metabolite profile.Discussion: The Canola-PAD Study uses an innovative and noninvasive approach to evaluate the effect of canola oil on clinically relevant outcomes in individuals with PAD, including

The psychopharmacology of aggressive behavior: a translational approach: part 2: clinical studies using atypical antipsychotics, anticonvulsants, and lithium.

Science.gov (United States)

Comai, Stefano; Tau, Michael; Pavlovic, Zoran; Gobbi, Gabriella

2012-04-01

Patients experiencing mental disorders are at an elevated risk for developing aggressive behavior. In the past 10 years, the psychopharmacological treatment of aggression has changed dramatically owing to the introduction of atypical antipsychotics on the market and the increased use of anticonvulsants and lithium in the treatment of aggressive patients.This review (second of 2 parts) uses a translational medicine approach to examine the neurobiology of aggression, discussing the major neurotransmitter systems implicated in its pathogenesis (serotonin, glutamate, norepinephrine, dopamine, and γ-aminobutyric acid) and the neuropharmacological rationale for using atypical antipsychotics, anticonvulsants, and lithium in the therapeutics of aggressive behavior. A critical review of all clinical trials using atypical antipsychotics (aripiprazole, clozapine, loxapine, olanzapine, quetiapine, risperidone, ziprasidone, and amisulpride), anticonvulsants (topiramate, valproate, lamotrigine, and gabapentin), and lithium are presented. Given the complex, multifaceted nature of aggression, a multifunctional combined therapy, targeting different receptors, seems to be the best strategy for treating aggressive behavior. This therapeutic strategy is supported by translational studies and a few human studies, even if additional randomized, double-blind, clinical trials are needed to confirm the clinical efficacy of this framework.

Theoretical Issues in Clinical Social Group Work.

Science.gov (United States)

Randall, Elizabeth; Wodarski, John S.

1989-01-01

Reviews relevant issues in clinical social group practice including group versus individual treatment, group work advantages, approach rationale, group conditions for change, worker role in group, group composition, group practice technique and method, time as group work dimension, pretherapy training, group therapy precautions, and group work…

Rationale for reduced tornado design bases

International Nuclear Information System (INIS)

Rutherford, P.D.; Ho, H.W.; Hartung, J.A.; Kastenberg, W.E.

1985-01-01

This paper provides a rationale for relaxing the present NRC tornado design requirements, which are based on a design basis tornado (DBT) whose frequency of exceedance is 10 -7 per year. It is proposed that a reduced DBT frequency of 10 -5 to 10 -6 per year is acceptable. This change in the tornado design bases for LMFBRs (and possibly all types of nuclear plants) is justified based on (1) existing NRC regulations and guidelines, (2) probabilistic arguments, (3) consistency with NRC trial safety goals, and (4) cost-benefit analysis

Commercially-driven human interplanetary propulsion systems: Rationale, concept, technology, and performance requirements

International Nuclear Information System (INIS)

Williams, C.H.; Borowski, S.K.

1996-01-01

Previous studies of human interplanetary missions are largely characterized by long trip times, limited performance capabilities, and enormous costs. Until these missions become dramatically more open-quote open-quote commercial-friendly close-quote close-quote, their funding source and rationale will be restricted to national governments and their political/scientific interests respectively. A rationale is discussed for human interplanetary space exploration predicated on the private sector. Space propulsion system requirements are identified for interplanetary transfer times of no more than a few weeks/months to and between the major outer planets. Nuclear fusion is identified as the minimum requisite space propulsion technology. A conceptual design is described and evolutionary catalyzed-DD to DHe 3 fuel cycles are proposed. Magnetic nozzles for direct thrust generation and quantifying the operational aspects of the energy exchange mechanisms between high energy reaction products and neutral propellants are identified as two of the many key supporting technologies essential to satisfying system performance requirements. Government support of focused, breakthrough technologies is recommended at funding levels appropriate to other ongoing federal research. copyright 1996 American Institute of Physics

Study rationale and design of OPTIMISE, a randomised controlled trial on the effect of benchmarking on quality of care in type 2 diabetes mellitus

Science.gov (United States)

2011-01-01

Background To investigate the effect of physician- and patient-specific feedback with benchmarking on the quality of care in adults with type 2 diabetes mellitus (T2DM). Methods Study centres in six European countries were randomised to either a benchmarking or control group. Physicians in both groups received feedback on modifiable outcome indicators (glycated haemoglobin [HbA1c], glycaemia, total cholesterol, high density lipoprotein-cholesterol, low density lipoprotein [LDL]-cholesterol and triglycerides) for each patient at 0, 4, 8 and 12 months, based on the four times yearly control visits recommended by international guidelines. The benchmarking group also received comparative results on three critical quality indicators of vascular risk (HbA1c, LDL-cholesterol and systolic blood pressure [SBP]), checked against the results of their colleagues from the same country, and versus pre-set targets. After 12 months of follow up, the percentage of patients achieving the pre-determined targets for the three critical quality indicators will be assessed in the two groups. Results Recruitment was completed in December 2008 with 3994 evaluable patients. Conclusions This paper discusses the study rationale and design of OPTIMISE, a randomised controlled study, that will help assess whether benchmarking is a useful clinical tool for improving outcomes in T2DM in primary care. Trial registration NCT00681850 PMID:21939502

Predicting asthma in preschool children with asthma symptoms: study rationale and design

Directory of Open Access Journals (Sweden)

Hafkamp-de Groen Esther

2012-10-01

Full Text Available Abstract Background In well-child care it is difficult to determine whether preschool children with asthma symptoms actually have or will develop asthma at school age. The PIAMA (Prevention and Incidence of Asthma and Mite Allergy Risk Score has been proposed as an instrument that predicts asthma at school age, using eight easy obtainable parameters, assessed at the time of first asthma symptoms at preschool age. The aim of this study is to present the rationale and design of a study 1 to externally validate and update the PIAMA Risk Score, 2 to develop an Asthma Risk Appraisal Tool to predict asthma at school age in (specific subgroups of preschool children with asthma symptoms and 3 to test implementation of the Asthma Risk Appraisal Tool in well-child care. Methods and design The study will be performed within the framework of Generation R, a prospective multi-ethnic cohort study. In total, consent for postnatal follow-up was obtained from 7893 children, born between 2002 and 2006. At preschool age the PIAMA Risk Score will be assessed and used to predict asthma at school age. Discrimination (C-index and calibration will be assessed for the external validation. We will study whether the predictive ability of the PIAMA Risk Score can be improved by removing or adding predictors (e.g. preterm birth. The (updated PIAMA Risk Score will be converted to the Asthma Risk Appraisal Tool- to predict asthma at school age in preschool children with asthma symptoms. Additionally, we will conduct a pilot study to test implementation of the Asthma Risk Appraisal Tool in well-child care. Discussion Application of the Asthma Risk Appraisal Tool in well-child care will help to distinguish preschool children at high- and low-risk of developing asthma at school age when asthma symptoms appear. This study will increase knowledge about the validity of the PIAMA risk score and might improve risk assessment of developing asthma at school age in (specific subgroups

Exploration in Ways and Rationales of Designing A Desirable Webquest

Institute of Scientific and Technical Information of China (English)

覃靓

2017-01-01

WebQuest is an advanced tool which could provide the significant scaffolding to support instructors through incorpo-rating learning objects within systematic designs of learning activities. The focus of this article is to explore how a Webquest is designed reasonably and what rationales are implied in such a design through a case study of Webquest design for a group of ESL/EFL learners in Grade 12. The result indicates that a Webquest which is guided by the principles of constructivist problem solving, social interaction and scaffolding learning can be regarded as a desirable Webquest.

Core outcome sets for research and clinical practice

NARCIS (Netherlands)

Chiarotto, Alessandro; Ostelo, Raymond W.; Turk, Dennis C.; Buchbinder, Rachelle; Boers, Maarten

2017-01-01

Background This masterclass introduces the topic of core outcome sets, describing rationale and methods for developing them, and providing some examples that are relevant for clinical research and practice. Method A core outcome set is a minimum consensus-based set of outcomes that should be

Rationales and treatment approaches underpinning the use of acupuncture and related techniques for plantar heel pain: a critical interpretive synthesis.

Science.gov (United States)

Clark, Maria T; Clark, Richard J; Toohey, Shane; Bradbury-Jones, Caroline

2017-03-01

Acupuncture shows promise as a treatment for plantar heel pain (PHP) or plantar fasciitis (PF), but data heterogeneity has undermined demonstration of efficacy. Recognising that acupuncture is a diverse field of practice, the aim of this study was to gain a broader, global perspective on the different approaches and rationales used in the application of acupuncture in PHP. We built upon an earlier systematic review (which was limited by the necessity of a methodological focus on efficacy) using the critical interpretive synthesis (CIS) method to draw upon a wider international sample of 25 clinical sources, including case reports and case series. Multiple tracks of analysis led to an emergent synthesis. Findings are presented at three levels: primary (summarised data); secondary (patterns observed); and tertiary (emergent synthesis). Multiple treatments and rationales were documented but no single approach dominated. Notable contradictions emerged such as the application of moxibustion by some authors and ice by others. Synthesis of findings revealed a 'patchwork' of factors influencing the approaches taken. The complexity of the field of acupuncture was illustrated through the 'lens' of PHP. The 'patchwork' metaphor provides a unifying framework for a previously divergent community of practice and research. Several directions for future research were identified, such as: importance of prior duration; existence of diagnostic subgroups; and how practitioners make clinical decisions and report their findings. CIS was found to provide visibility for multiple viewpoints in developing theory and modelling the processes of 'real world' practice by acupuncturists addressing the problem of PHP. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Rationale, design, and cohort enrolment of a prospective observational study of the clinical performance of the new contraceptive implant (Femplant) in Pakistan.

Science.gov (United States)

Azmat, Syed Khurram; Hameed, Waqas; Lendvay, Anja; Shaikh, Babar Tasneem; Mustafa, Ghulam; Siddiqui, Muhammad Ahmed; Brohi, Sajid; Karim, Asif; Ishaque, Muhammad; Hussain, Wajahat; Bilgrami, Mohsina; Feldblum, Paul J

2014-01-01

The use of hormonal implants has gained positive traction in family planning programs in recent times. Compared to other popular methods, such as long-term reversible intrauterine devices, the use of hormonal implants as a family planning method has distinct advantages in terms of long-term efficiency and better user compliance and availability. This paper presents a study protocol to document and evaluate the efficacy, safety, and acceptability of Femplant (contraceptive implant) in Pakistan during the first year of its use among married women of reproductive age (18-44 years) at clinics in two provinces of Pakistan (Sindh and Punjab). A total of 724 married women were enrolled in a noncomparative prospective observational study. The study involved six government clinics from the Population Welfare Department in Sindh Province and 13 clinics run by the Marie Stopes Society (a local nongovernmental organization) in both provinces. The participation of women was subject to voluntary acceptance and medical eligibility. All respondents were interviewed at baseline and subsequently at each scheduled visit during the study period. Side effects, complications and adverse events, if any, were recorded for every participant at each visit to the facility. Over the next 5-year period (2013-2018), 27 million hormonal implants will be made available in lower- to middle-income countries by international donors and agencies. The evidence generated from this study will identify factors affecting the acceptability and satisfaction of end users with Femplant (Sino-implant II). This will help to guide policies to enhance access to and the use of long-acting contraceptive implants in Pakistan and similar developing countries.

Hermeneutics framework: integration of design rationale and optimizing software modules

NARCIS (Netherlands)

Aksit, Mehmet; Malakuti Khah Olun Abadi, Somayeh

To tackle the evolution challenges of adaptive systems, this paper argues on the necessity of hermeneutic approaches that help to avoid too early elimination of design alternatives. This visionary paper proposes the Hermeneutics Framework, which computationally integrates a design rationale

HAMMLAB 1999 experimental control room: design - design rationale - experiences

International Nuclear Information System (INIS)

Foerdestroemmen, N. T.; Meyer, B. D.; Saarni, R.

1999-01-01

A presentation of HAMMLAB 1999 experimental control room, and the accumulated experiences gathered in the areas of design and design rationale as well as user experiences. It is concluded that HAMMLAB 1999 experimental control room is a realistic, compact and efficient control room well suited as an Advanced NPP Control Room (ml)

Rationale and clinical utility of the darunavir–cobicistat combination in the treatment of HIV/AIDS

Directory of Open Access Journals (Sweden)

Putcharoen O

2015-10-01

Full Text Available Opass Putcharoen,1 Tanya Do,2 Anchalee Avihingsanon,2 Kiat Ruxrungtham1,2 1Department of Medicine, Faculty of Medicine, Chulalongkorn University, 2The HIV Netherlands Australia Thailand (HIV-NAT Research Collaboration, The Thai Red Cross AIDS Research Center, Bangkok, Thailand Abstract: This article is to provide an update overview of cobicistat (COBI-boosted darunavir in response to its recent approval by the US Food and Drug Administration, and inclusion as an alternative first-line regime in the 2015 treatment guidelines in the US. COBI is a relatively new non-antiretroviral cytochrome P450 3A inhibitor or pharmacoenhancer. The rationale behind COBI development was to provide an alternative to ritonavir (RTV as a protease inhibitor pharmacoenhancer, due to associated adverse events with short- and long-term RTV use, such as gastrointestinal intolerability, drug–drug interactions, insulin resistance, lipodystrophy, and hyperlipidemia. Although in vitro studies suggest that COBI may result in a lower incidence of undesired drug–drug interactions and lipid-associated disorders than RTV, not all Phase III studies have well addressed these issues, and the data are limited. However, Phase III studies have demonstrated tolerability, noninferiority, and bioequivalence of COBI compared to RTV. Two main advantages of COBI over RTV-containing regimes have been noted as follows: 1 COBI has no anti-HIV activity; therefore, resistance to COBI as a booster in addition to protease inhibitor resistance is of little concern, allowing for COBI-containing regimes in future. 2 COBI’s solubility and dissolution rate allow for co-formulated/fixed-dose combination products. Nonetheless, prior to initiating COBI-containing treatment regimens, the following should be considered: 1 COBI may increase serum creatinine levels and reduce estimated glomerular filtration rate (GFR without affecting actual GFR; 2 potential drug–drug interaction data are insufficient

A cluster randomized trial to assess the impact of clinical pathways for patients with stroke: rationale and design of the Clinical Pathways for Effective and Appropriate Care Study [NCT00673491

Directory of Open Access Journals (Sweden)

Barbieri Antonella

2008-11-01

Full Text Available Abstract Background Patients with stroke should have access to a continuum of care from organized stroke units in the acute phase, to appropriate rehabilitation and secondary prevention measures. Moreover to improve the outcomes for acute stroke patients from an organizational perspective, the use of multidisciplinary teams and the delivery of continuous stroke education both to the professionals and to the public, and the implementation of evidence-based stroke care are recommended. Clinical pathways are complex interventions that can be used for this purpose. However in stroke care the use of clinical pathways remains questionable because little prospective controlled data has demonstrated their effectiveness. The purpose of this study is to determine whether clinical pathways could improve the quality of the care provided to the patients affected by stroke in hospital and through the continuum of the care. Methods Two-arm, cluster-randomized trial with hospitals and rehabilitation long-term care facilities as randomization units. 14 units will be randomized either to arm 1 (clinical pathway or to arm 2 (no intervention, usual care. The sample will include 238 in each group, this gives a power of 80%, at 5% significance level. The primary outcome measure is 30-days mortality. The impact of the clinical pathways along the continuum of care will also be analyzed by comparing the length of hospital stay, the hospital re-admissions rates, the institutionalization rates after hospital discharge, the patients' dependency levels, and complication rates. The quality of the care provided to the patients will be assessed by monitoring the use of diagnostic and therapeutic procedures during hospital stay and rehabilitation, and by the use of key quality indicators at discharge. The implementation of organized care will be also evaluated. Conclusion The management of patients affected by stroke involves the expertise of several professionals, which can

Rationale, design and objectives of ARegPKD, a European ARPKD registry study.

Science.gov (United States)

Ebner, Kathrin; Feldkoetter, Markus; Ariceta, Gema; Bergmann, Carsten; Buettner, Reinhard; Doyon, Anke; Duzova, Ali; Goebel, Heike; Haffner, Dieter; Hero, Barbara; Hoppe, Bernd; Illig, Thomas; Jankauskiene, Augustina; Klopp, Norman; König, Jens; Litwin, Mieczyslaw; Mekahli, Djalila; Ranchin, Bruno; Sander, Anja; Testa, Sara; Weber, Lutz Thorsten; Wicher, Dorota; Yuzbasioglu, Ayse; Zerres, Klaus; Dötsch, Jörg; Schaefer, Franz; Liebau, Max Christoph

2015-02-18

Autosomal recessive polycystic kidney disease (ARPKD) is a rare but frequently severe disorder that is typically characterized by cystic kidneys and congenital hepatic fibrosis but displays pronounced phenotypic heterogeneity. ARPKD is among the most important causes for pediatric end stage renal disease and a leading reason for liver-, kidney- or combined liver kidney transplantation in childhood. The underlying pathophysiology, the mechanisms resulting in the observed clinical heterogeneity and the long-term clinical evolution of patients remain poorly understood. Current treatment approaches continue to be largely symptomatic and opinion-based even in most-advanced medical centers. While large clinical trials for the frequent and mostly adult onset autosomal dominant polycystic kidney diseases have recently been conducted, therapeutic initiatives for ARPKD are facing the challenge of small and clinically variable cohorts for which reliable end points are hard to establish. ARegPKD is an international, mostly European, observational study to deeply phenotype ARPKD patients in a pro- and retrospective fashion. This registry study is conducted with the support of the German Society for Pediatric Nephrology (GPN) and the European Study Consortium for Chronic Kidney Disorders Affecting Pediatric Patients (ESCAPE Network). ARegPKD clinically characterizes long-term ARPKD courses by a web-based approach that uses detailed basic data questionnaires in combination with yearly follow-up visits. Clinical data collection is accompanied by associated biobanking and reference histology, thus setting roots for future translational research. The novel registry study ARegPKD aims to characterize miscellaneous subcohorts and to compare the applied treatment options in a large cohort of deeply characterized patients. ARegPKD will thus provide evidence base for clinical treatment decisions and contribute to the pathophysiological understanding of this severe inherited disorder.

Clinical trial design and rationale of the Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 (MOMENTUM 3) investigational device exemption clinical study protocol.

Science.gov (United States)

Heatley, Gerald; Sood, Poornima; Goldstein, Daniel; Uriel, Nir; Cleveland, Joseph; Middlebrook, Don; Mehra, Mandeep R

2016-04-01

The HeartMate 3 left ventricular assist system (LVAS; St. Jude Medical, Inc., formerly Thoratec Corporation, Pleasanton, CA) was recently introduced into clinical trials for durable circulatory support in patients with medically refractory advanced-stage heart failure. This centrifugal, fully magnetically levitated, continuous-flow pump is engineered with the intent to enhance hemocompatibility and reduce shear stress on blood elements, while also possessing intrinsic pulsatility. Although bridge-to-transplant (BTT) and destination therapy (DT) are established dichotomous indications for durable left ventricular assist device (LVAD) support, clinical practice has challenged the appropriateness of these designations. The introduction of novel LVAD technology allows for the development of clinical trial designs to keep pace with current practices. The prospective, randomized Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 (MOMENTUM 3) clinical trial aims to evaluate the safety and effectiveness of the HeartMate 3 LVAS by demonstrating non-inferiority to the HeartMate II LVAS (also St. Jude Medical, Inc.). The innovative trial design includes patients enrolled under a single inclusion and exclusion criteria , regardless of the intended use of the device, with outcomes ascertained in the short term (ST, at 6 months) and long term (LT, at 2 years). This adaptive trial design includes a pre-specified safety phase (n = 30) analysis. The ST cohort includes the first 294 patients and the LT cohort includes the first 366 patients for evaluation of the composite primary end-point of survival to transplant, recovery or LVAD support free of debilitating stroke (modified Rankin score >3), or re-operation to replace the pump. As part of the adaptive design, an analysis by an independent statistician will determine whether sample size adjustment is required at pre-specified times during the study. A further 662

Physics rationale for the engineering specifications for ZTH

International Nuclear Information System (INIS)

Dimarco, J.N.

1987-01-01

This report presents the physics rationale that established the engineering design of ZTH. The physics criteria are given and the implications regarding the engineering design are presented. Experimental and theoretical background evidence is given in support of the criteria but the justification is left to other reports and peer reviews. The physics criteria discussed here are limited to the ones deemed to be of highest engineering priority. 32 refs., 9 figs

Safe and effective prescription of exercise in acute exacerbations of chronic obstructive pulmonary disease: rationale and methods for an integrated knowledge translation study.

Science.gov (United States)

Camp, Pat; Reid, W Darlene; Yamabayashi, Cristiane; Brooks, Dina; Goodridge, Donna; Chung, Frank; Marciniuk, Darcy D; Neufeld, Andrea; Hoens, Alsion

2013-01-01

Patients hospitalized with an acute exacerbation of chronic obstructive pulmonary disease (AECOPD) engage in low levels of activity, putting them at risk for relapse and future readmissions. There is little direction for health care providers regarding the parameters for safe exercise during an AECOPD that is effective for increasing activity tolerance before discharge from hospital, especially for patients with associated comorbid conditions. To report the rationale for and methods of a study to develop evidence-informed care recommendations that guide health care providers in the assessment, prescription, monitoring and progression of exercise for patients hospitalized with AECOPD. The present study was a multicomponent knowledge translation project incorporating evidence from systematic reviews of exercise involving populations with chronic obstructive pulmonary disease and⁄or common comorbidities. A Delphi process was then used to obtain expert opinion from clinicians, academics and patients to identify the parameters of safe and effective exercise for patients with AECOPD. Clinical decision-making tool(s) for patients and practitioners supported by a detailed knowledge dissemination, implementation and evaluation framework. The present study addressed an important knowledge gap: the lack of availability of parameters to guide safe and effective exercise prescription for hospitalized patients with AECOPD, with or without comorbid conditions. In the absence of such parameters, health care professionals may adopt an 'activity as tolerated' approach, which may not improve physical activity levels in their patients. The present study synthesizes the best available evidence and expert opinion, and will generate decision-making tools for use by patients and their health care providers.

Karl Popper and Jean Piaget: A Rationale for Constructivism

Science.gov (United States)

Harlow, Steve; Cummings, Rhoda; Aberasturi, Suzanne M.

2006-01-01

The current faddish use of the term constructivism has taken on as many different definitions as the number of people attempting to define it. This essay clarifies the meaning of constructivism through an examination of Karl Popper's and Jean Piaget's theories. The authors provide a rationale for the use of Popper's paradigm of "Three Worlds" and…

Bonding to oxide ceramics—laboratory testing versus clinical outcome.

Science.gov (United States)

Kern, Matthias

2015-01-01

Despite a huge number of published laboratory bonding studies on dental oxide ceramics clinical long-term studies on resin bonded oxide ceramic restorations are rare. The purpose of this review is to present the best available clinical evidence for successful bonding of dental oxide ceramic restorations. Clinical trials with resin-bonded restorations that had no or only limited mechanical retention and were made from alumina or zirconia ceramic were identified using an electronic search in PubMed database. Overall 10 publications with clinical trials could be identified. Their clinical outcome was compared with that laboratory bond strength studies. Clinical data provide strong evidence that air-abrasion at a moderate pressure in combination with using phosphate monomer containing primers and/or luting resins provide long-term durable bonding to glass-infiltrated alumina and zirconia ceramic under the humid and stressful oral conditions. As simple and clinically reliable bonding methods to oxide ceramics exist, the rationale for development of alternative bonding methods might be reconsidered especially when these methods are more time consuming or require rather complicated and/or technique sensitive procedures. Copyright © 2014 Academy of Dental Materials. Published by Elsevier Ltd. All rights reserved.

Supporting awareness in creative group work by exposing design rationale

Directory of Open Access Journals (Sweden)

Umer Farooq

2011-01-01

Full Text Available When creativity is taken as a long-term, complex, and collaborative activity, support for awareness is required for group members to monitor the development of ideas, track how these ideas became narrowed, and understand how alternatives are being implemented and integrated by colleagues. In this paper, we investigate the effects of exposing design rationale to convey awareness, specifically activity awareness, in group creativity. Through evaluating a prototype, we investigate status updates that convey design rationale, and to what consequences, in small groups in fully distributed collaboration. We found that status updates are used for a variety of purposes and that participants’ comments on their collaborators’ status updates provided feedback. Overall, results suggest that participants’ awareness about their collaborators’ future plans increased over time. Majority of participants found the status updates useful, particularly those with higher metacognitive knowledge. Based on our results, two design strategies for activity awareness are proposed.

The Impact of a Course on Nature of Science Pedagogical Views and Rationales. Comparing Preservice Teachers in Their First Versus Second Experience

Science.gov (United States)

Kruse, Jerrid W.; Easter, Jaclyn M.; Edgerly, Hallie S.; Seebach, Colin; Patel, Neal

2017-08-01

This study explored changes in preservice teachers' (PSTs) nature of science pedagogical (NOSP) views and nature of science (NOS) rationales using pre- and post-course written responses as well as interview data. Through systematic analysis, themes were generated and compared to the NOS literature. Comparisons between pre- and post-course data demonstrate improved and deepened NOS views, NOSP views that are more aligned with NOS literature, and a greater number of rationales for including NOS. All participants were enrolled in the "Inquiry and Natures of Science, Technology, and Engineering" (INSTE) course. However, six participants were enrolled in INSTE as their first course in which NOS and NOSP were addressed. The other six participants were enrolled in INSTE as their second course in which NOS and NOSP were addressed, with science methods as their first course in which NOS and NOSP were addressed. By comparing participants enrolled in INSTE as their first course to those enrolled in INSTE as their second course, we observed that NOS understanding seemed to develop in a first experience alongside some NOS rationales, but NOSP views lagged for participants in INSTE as their first course. Participants enrolled in INSTE as their second course developed more robust and literature-aligned NOSP views and more multifaceted NOS rationales. Therefore, this study bolsters arguments that teachers need to receive extended NOS and NOSP instruction.

Rationale for statistical characteristics of road safety parameters

Directory of Open Access Journals (Sweden)

Dormidontova Tatiana

2017-01-01

Full Text Available When making engineering decisions at the stage of designing auto-roads and man-made structures it is necessary to take into account the statistical variability of physical and mechanical characteristics of the used materials as well as the different effects on the structures. Thus the rationale for the statistical characteristics of the parameters that determine the reliability of roads and man-made engineering facilities is of particular importance.There are many factors to be considered while designing roads, such as natural climatic factors, the accidental effects of the operating loads, the strength and deformation characteristics of the materials, the geometric parameters of the structure, etc. which affect the strength characteristics of roads and man-made structures. The rationale for statistical characteristics of the parameters can help an engineer assess the reliability of the decision and the economic risk, as well as avoid making mistakes in the design of roads and man-made structures.However, some statistical characteristics of the parameters that define the reliability of a road and man-made structures play a key role in the design. These are the visibility distance in daytime for the peak curve, variation coefficient of radial acceleration, the reliability of visibility distance and other parameters.

Sampling in Qualitative Research: Rationale, Issues, and Methods

OpenAIRE

LUBORSKY, MARK R.; RUBINSTEIN, ROBERT L.

1995-01-01

In gerontology the most recognized and elaborate discourse about sampling is generally thought to be in quantitative research associated with survey research and medical research. But sampling has long been a central concern in the social and humanistic inquiry, albeit in a different guise suited to the different goals. There is a need for more explicit discussion of qualitative sampling issues. This article will outline the guiding principles and rationales, features, and practices of sampli...

The rationales of resilience in English and Dutch flood risk policies

NARCIS (Netherlands)

Wiering, M.A.; Green, C.; Rijswick, M. van; Priest, S.J.; Keessen, A.M.

2015-01-01

We compared the governance of flood risk in England and the Netherlands, focusing on the general policies, instruments used and underlying principles. Both physical and political environments are important in explaining how countries evolved towards very different rationales of

[Sex and gender equity in research: rationale for the SAGER guidelines and recommended use].

Science.gov (United States)

Heidari, Shirin; Babor, Thomas F; De Castro, Paola; Tort, Sera; Curno, Mirjam

2018-05-03

Sex and gender differences are often overlooked in research design, study implementation and scientific reporting, as well as in general science communication. This oversight limits the generalizability of research findings and their applicability to clinical practice, in particular for women but also for men. This article describes the rationale for an international set of guidelines to encourage a more systematic approach to the reporting of sex and gender in research across disciplines. A panel of 13 experts representing nine countries developed the guidelines through a series of teleconferences, conference presentations and a 2-day workshop. An internet survey of 716 journal editors, scientists and other members of the international publishing community was conducted as well as a literatura search on sex and gender policies in scientific publishing. The Sex and Gender Equity in Research (SAGER) guidelines are a comprehensive procedure for reporting of sex and gender information in study design, data analyses, results and interpretation of findings. The SAGER guidelines are designed primarily to guide authors in preparing their manuscripts, but they are also useful for editors, as gatekeepers of science, to integrate assessment of sex and gender into all manuscripts as an integral part of the editorial process. Copyright © 2018 SESPAS. Publicado por Elsevier España, S.L.U. All rights reserved.

New knowledge network evaluation method for design rationale management

Science.gov (United States)

Jing, Shikai; Zhan, Hongfei; Liu, Jihong; Wang, Kuan; Jiang, Hao; Zhou, Jingtao

2015-01-01

Current design rationale (DR) systems have not demonstrated the value of the approach in practice since little attention is put to the evaluation method of DR knowledge. To systematize knowledge management process for future computer-aided DR applications, a prerequisite is to provide the measure for the DR knowledge. In this paper, a new knowledge network evaluation method for DR management is presented. The method characterizes the DR knowledge value from four perspectives, namely, the design rationale structure scale, association knowledge and reasoning ability, degree of design justification support and degree of knowledge representation conciseness. The DR knowledge comprehensive value is also measured by the proposed method. To validate the proposed method, different style of DR knowledge network and the performance of the proposed measure are discussed. The evaluation method has been applied in two realistic design cases and compared with the structural measures. The research proposes the DR knowledge evaluation method which can provide object metric and selection basis for the DR knowledge reuse during the product design process. In addition, the method is proved to be more effective guidance and support for the application and management of DR knowledge.

Rationale of physical rehabilitation of patients with violation coronary circulation

Directory of Open Access Journals (Sweden)

Anvar Morad Pour Heidari Roudberi

2013-09-01

Full Text Available The aim of the study is to examine the risk factors that lead to the violation of the coronary circulation. Rationale for the use of physical rehabilitation to restore optimal hemodynamics in the myocardium. Considered views on the causes of the high mortality rate of the population of Ukraine of cardiovascular disease. It is shown that the main cause of death is coronary heart disease. Suggested that the major risk factors for coronary heart disease is high cholesterol, hypertension and obesity. Proposed to use exercise therapy, dosage walking, psychotherapy, autogenic training and diet therapy in rehabilitation program patients with impaired coronary circulation.

Clinical results in heavy particle radiotherapy

International Nuclear Information System (INIS)

Castro, J.R.; Quivey, J.M.; Saunders, W.M.; Woodruff, K.H.; Chen, G.T.Y.; Lyman, J.T.; Pitluck, S.; Tobias, C.A.; Walton, R.E.; Peters, T.C.

1980-01-01

The chapter presents an overview of the use of heavy particles in human cancer radiotherapy. The biophysical characteristics and rationale for using heavy charged particle therapy are explored. The clinical experience with carbon, neon, argon and helium are summarized for various types of tumors including carcinomas of the uterine cervix and lung, skin melanomas and metastatic sarcomas. No obvious normal tissue complications have appeared

The population-based Barcelona-Asymptomatic Intracranial Atherosclerosis Study (ASIA: rationale and design

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Pera Guillem

2011-02-01

Full Text Available Abstract Background Large-artery intracranial atherosclerosis may be the most frequent cause of ischemic stroke worldwide. Traditional approaches have attempted to target the disease when it is already symptomatic. However, early detection of intracranial atherosclerosis may allow therapeutic intervention while the disease is still asymptomatic. The prevalence and natural history of asymptomatic intracranial atherosclerosis in Caucasians remain unclear. The aims of the Barcelona-ASymptomatic Intracranial Atherosclerosis (ASIA study are (1 to determine the prevalence of ASIA in a moderate-high vascular risk population, (2 to study its prognostic impact on the risk of suffering future major ischemic events, and (3 to identify predictors of the development, progression and clinical expression of this condition. Methods/Design Cross-over and cohort, population-based study. A randomly selected representative sample of 1,503 subjects with a mild-moderate-high vascular risk (as defined by a REGICOR score ≥ 5% and with neither a history of cerebrovascular nor ischemic heart disease will be studied. At baseline, all individuals will undergo extracranial and transcranial Color-Coded Duplex (TCCD ultrasound examinations to detect presence and severity of extra and intracranial atherosclerosis. Intracranial stenoses will be assessed by magnetic resonance angiography (MRA. Clinical and demographic variables will be recorded and blood samples will be drawn to investigate clinical, biological and genetic factors associated with the presence of ASIA. A long-term clinical and sonographic follow-up will be conducted thereafter to identify predictors of disease progression and of incident vascular events. Discussion The Barcelona-ASIA is a population-based study aiming to evaluate the prevalence and clinical importance of asymptomatic intracranial large-artery atherosclerosis in Caucasians. The ASIA project may provide a unique scientific resource to better

The population-based Barcelona-Asymptomatic Intracranial Atherosclerosis Study (ASIA): rationale and design.

Science.gov (United States)

López-Cancio, Elena; Dorado, Laura; Millán, Mónica; Reverté, Silvia; Suñol, Anna; Massuet, Anna; Mataró, María; Galán, Amparo; Alzamora, Maite; Pera, Guillem; Torán, Pere; Dávalos, Antoni; Arenillas, Juan F

2011-02-17

Large-artery intracranial atherosclerosis may be the most frequent cause of ischemic stroke worldwide. Traditional approaches have attempted to target the disease when it is already symptomatic. However, early detection of intracranial atherosclerosis may allow therapeutic intervention while the disease is still asymptomatic. The prevalence and natural history of asymptomatic intracranial atherosclerosis in Caucasians remain unclear. The aims of the Barcelona-ASymptomatic Intracranial Atherosclerosis (ASIA) study are (1) to determine the prevalence of ASIA in a moderate-high vascular risk population, (2) to study its prognostic impact on the risk of suffering future major ischemic events, and (3) to identify predictors of the development, progression and clinical expression of this condition. Cross-over and cohort, population-based study. A randomly selected representative sample of 1,503 subjects with a mild-moderate-high vascular risk (as defined by a REGICOR score ≥ 5%) and with neither a history of cerebrovascular nor ischemic heart disease will be studied. At baseline, all individuals will undergo extracranial and transcranial Color-Coded Duplex (TCCD) ultrasound examinations to detect presence and severity of extra and intracranial atherosclerosis. Intracranial stenoses will be assessed by magnetic resonance angiography (MRA). Clinical and demographic variables will be recorded and blood samples will be drawn to investigate clinical, biological and genetic factors associated with the presence of ASIA. A long-term clinical and sonographic follow-up will be conducted thereafter to identify predictors of disease progression and of incident vascular events. The Barcelona-ASIA is a population-based study aiming to evaluate the prevalence and clinical importance of asymptomatic intracranial large-artery atherosclerosis in Caucasians. The ASIA project may provide a unique scientific resource to better understand the dynamics of intracranial atherosclerosis from

Rationale for the Cultural Construction of School Mental Health Programming

Science.gov (United States)

Arora, Prerna G.; Nastasi, Bonnie K.; Leff, Stephen S.

2017-01-01

The implementation of evidence-based psychological programming to meet the needs of a global population has been impeded by the translation of theories and research findings across populations and settings without due consideration of cultural factors. The purpose of this article is to discuss the rationale for use of partnership-based methods in…

Tranexamic acid for acute intracerebral hemorrhage growth predicted by spot sign trial: Rationale and design.

Science.gov (United States)

Liu, Liping; Wang, Yilong; Meng, Xia; Li, Na; Tan, Ying; Nie, Ximing; Liu, Dacheng; Zhao, Xingquan

2017-04-01

Rationale Acute intracerebral hemorrhage inflicts a high-economic and -health burden. Computed tomography angiography spot sign is a predictor of hematoma expansion, is associated with poor clinical outcome and is an important stratifying variable for patients treated with haemostatic therapy. Aims We aim to compare the effect of treatment with tranexamic acid to placebo for the prevention of hemorrhage growth in patients with high-risk acute intracerebral hemorrhage with a positive spot sign. Design The tranexamic acid for acute intracerebral hemorrhage growth predicted by spot sign (TRAIGE) is a prospective, multicenter, placebo-controlled, double-blind, investigator-led, randomized clinical trial that will include an estimated 240 participants. Patients with intracerebral hemorrhage demonstrating symptom onset within 8 h and with the spot sign as a biomarker for ongoing hemorrhage, and no contraindications for antifibrinolytic therapy, will be enrolled to receive either tranexamic acid or placebo. The primary outcome measure is the presence of hemorrhage growth defined as an increase in intracerebral hemorrhage volume >33% or >6 ml from baseline to 24 ± 2 h. The secondary outcomes include safety and clinical outcomes. Conclusion The TRAIGE trial evaluates the efficacy of haemostatic therapy with tranexamic acid in the prevention of hemorrhage growth among high-risk patients with acute intracerebral hemorrhage.

Platelet-rich plasma: why intra-articular? A systematic review of preclinical studies and clinical evidence on PRP for joint degeneration.

Science.gov (United States)

Filardo, G; Kon, E; Roffi, A; Di Matteo, B; Merli, M L; Marcacci, M

2015-09-01

The aim of this review was to analyze the available evidence on the clinical application of this biological approach for the injective treatment of cartilage lesions and joint degeneration, together with preclinical studies to support the rationale for the use of platelet concentrates, to shed some light and give indications on what to treat and what to expect from intra-articular injections of platelet-rich plasma (PRP). All in vitro, in vivo preclinical and clinical studies on PRP injective treatment in the English language concerning the effect of PRP on cartilage, synovial tissue, menisci, and mesenchymal stem cells were considered. A systematic review on the PubMed database was performed using the following words: (platelet-rich plasma or PRP or platelet concentrate or platelet lysate or platelet supernatant) and (cartilage or chondrocytes or synoviocytes or menisci or mesenchymal stem cells). Fifty-nine articles met the inclusion criteria: 26 were in vitro, 9 were in vivo, 2 were both in vivo and in vitro, and 22 were clinical studies. The analysis showed an increasing number of published studies over time. Preclinical evidence supports the use of PRP injections that might promote a favourable environment for joint tissues healing. Only a few high-quality clinical trials have been published, which showed a clinical improvement limited over time and mainly documented in younger patients not affected by advanced knee degeneration. Besides the limits and sometimes controversial findings, the preclinical literature shows an overall support toward this PRP application. An intra-articular injection does not just target cartilage; instead, PRP might influence the entire joint environment, leading to a short-term clinical improvement. Many biological variables might influence the clinical outcome and have to be studied to optimize PRP injective treatment of cartilage degeneration and osteoarthritis.

Rationale, design, and cohort enrolment of a prospective observational study of the clinical performance of the new contraceptive implant (Femplant in Pakistan

Directory of Open Access Journals (Sweden)

Azmat SK

2014-05-01

Full Text Available Syed Khurram Azmat,1 Waqas Hameed,1 Anja Lendvay,2 Babar Tasneem Shaikh,3 Ghulam Mustafa,1 Muhammad Ahmed Siddiqui,1 Sajid Brohi,1 Asif Karim,1 Muhammad Ishaque,1 Wajahat Hussain,1 Mohsina Bilgrami,1 Paul J Feldblum2 1Research, Monitoring and Evaluation Department, Marie Stopes Society, Karachi, Pakistan; 2FHI 360, Durham, NC, USA; 3Health Services Academy, Islamabad, Pakistan Introduction: The use of hormonal implants has gained positive traction in family planning programs in recent times. Compared to other popular methods, such as long-term reversible intrauterine devices, the use of hormonal implants as a family planning method has distinct advantages in terms of long-term efficiency and better user compliance and availability. This paper presents a study protocol to document and evaluate the efficacy, safety, and acceptability of Femplant (contraceptive implant in Pakistan during the first year of its use among married women of reproductive age (18–44 years at clinics in two provinces of Pakistan (Sindh and Punjab. Materials and methods: A total of 724 married women were enrolled in a noncomparative prospective observational study. The study involved six government clinics from the Population Welfare Department in Sindh Province and 13 clinics run by the Marie Stopes Society (a local nongovernmental organization in both provinces. The participation of women was subject to voluntary acceptance and medical eligibility. All respondents were interviewed at baseline and subsequently at each scheduled visit during the study period. Side effects, complications and adverse events, if any, were recorded for every participant at each visit to the facility. Discussion: Over the next 5-year period (2013–2018, 27 million hormonal implants will be made available in lower- to middle-income countries by international donors and agencies. The evidence generated from this study will identify factors affecting the acceptability and satisfaction of end

Telework rationale and implementation for people with disabilities: considerations for employer policymaking.

Science.gov (United States)

Moon, Nathan W; Linden, Maureen A; Bricout, John C; Baker, Paul M A

2014-01-01

Telework has been promoted as a viable workplace accommodation for people with disabilities since the 1990s, when information and communication technologies (ICT) had developed sufficiently to facilitate its widespread adoption. This initial research and accompanying policy recommendations were prescriptive in nature and frequently aimed at employers. This article adds to existing policy models for facilitating successful telework outcomes for people with disabilities. Drawing upon two studies by the Rehabilitation Engineering Research Center on Workplace Accommodations, we expound on employee-side considerations in the implementation of telework. Our policy model utilizes established typologies for policy evaluation to develop a process model that considers rationales and implementation factors for telework among people with physical disabilities. Telework may be used as an accommodation for disability, but employee rationales for telework are more complex, involving work-life balance, strategies for pain and fatigue not formally recognized as disability, and expediency in travel and transportation. Implementation of telework as a component of workplace operations is similarly multifaceted, involving non-technology accommodations to realize job restructuring left incomplete by telework. Our model grounds new empirical research in this area. We also renew our call for additional research on effective telework practices for people with disabilities.

The ‘grey’ assessment practice of IA screening: Prevalence, influence and applied rationale

International Nuclear Information System (INIS)

Bidstrup, Morten

2017-01-01

Research focusing on the practices surrounding screening in Impact Assessment (IA) is limited. Yet, it has been found that development proposals sometimes are adjusted through an informal dialog with IA practitioners prior to or during screening. Such practice is often referred to as ‘grey IA’ in Denmark. This article explores the prevalence, influence and applied rationale of grey IA. Through a questionnaire, data was collected from 121 IA practitioners working within the fields of environmental impact assessment and strategic environmental assessment. It was found that grey IA is a common practice, which influences the outcomes of formal screening procedures through consideration of impacts on neighbours and spatial zones of protection. Grey IA is to some extent motivated by the opportunity to save the resources required for full-scale IA, but an additional ‘green’ rationale also exists. Grey IA may influence the effectiveness of IA systems, but further research is needed before any conclusions can be made. - Highlights: • Screening procedures may function as an informal, ‘grey’ assessment. • Grey assessment is common and influences formal screening outcomes. • Grey assessment is motivated by an opportunity to cut IA costs. • Yet, an environmental, ‘green’ rationale for grey assessment also exists.

The ‘grey’ assessment practice of IA screening: Prevalence, influence and applied rationale

Energy Technology Data Exchange (ETDEWEB)

Bidstrup, Morten, E-mail: Bidstrup@plan.aau.dk

2017-01-15

Research focusing on the practices surrounding screening in Impact Assessment (IA) is limited. Yet, it has been found that development proposals sometimes are adjusted through an informal dialog with IA practitioners prior to or during screening. Such practice is often referred to as ‘grey IA’ in Denmark. This article explores the prevalence, influence and applied rationale of grey IA. Through a questionnaire, data was collected from 121 IA practitioners working within the fields of environmental impact assessment and strategic environmental assessment. It was found that grey IA is a common practice, which influences the outcomes of formal screening procedures through consideration of impacts on neighbours and spatial zones of protection. Grey IA is to some extent motivated by the opportunity to save the resources required for full-scale IA, but an additional ‘green’ rationale also exists. Grey IA may influence the effectiveness of IA systems, but further research is needed before any conclusions can be made. - Highlights: • Screening procedures may function as an informal, ‘grey’ assessment. • Grey assessment is common and influences formal screening outcomes. • Grey assessment is motivated by an opportunity to cut IA costs. • Yet, an environmental, ‘green’ rationale for grey assessment also exists.

Clinical Study of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) for Severe Pelvic Fracture and Intra Abdominal Hemorrhagic Shock using Continuous Vital Signs

Science.gov (United States)

2016-03-01

aorta extending from the lowest renal artery to the aortic bifurcation. Despite the anatomic plausibility of Stannard’s technical description, it is...resuscitative thoracotomy. Zone II is the paravisceral segment and was proposed as a potential no-occlusion zone, while Zone III represents the infra- renal ...not a clinical report, simply an anatomic recommendation based on zones of aortic perfusion. The rationale behind REBOA follows the understanding

Critique of rationale for transmutation of nuclear waste

International Nuclear Information System (INIS)

Smith, C.F.; Cohen, J.J.

1980-07-01

It has been suggested that nuclear transmutation could be used in the elimination or reduction of hazards from radioactive wastes. The rationale for this suggestion is the subject of this paper. The objectives of partitioning-transmutation are described. The benefits are evaluated. The author concludes that transmutation would appear at best to offer the opportunity of reducing an already low risk. This would not seem to be justifiable considering the cost. If non-radiological risks are considered, there is a negative total benefit

Integrating clinical communication with clinical reasoning and the broader medical curriculum.

Science.gov (United States)

Cary, Julie; Kurtz, Suzanne

2013-09-01

The objectives of this paper are to discuss the results of a workshop conducted at EACH 2012. Specifically, we will (1) examine the link between communication, clinical reasoning, and medical problem solving, (2) explore strategies for (a) integrating clinical reasoning, medical problem solving, and content from the broader curriculum into clinical communication teaching and (b) integrating communication into the broader curriculum, and (3) discuss benefits gained from such integration. Salient features from the workshop were recorded and will be presented here, as well as a case example to illustrate important connections between clinical communication and clinical reasoning. Potential links between clinical communication, clinical reasoning, and medical problem solving as well as strategies to integrate clinical communication teaching and the broader curricula in human and veterinary medicine are enumerated. Participants expressed enthusiasm and keen interest in integration of clinical communication teaching and clinical reasoning during this workshop, came to the idea of the interdependence of these skills easily, and embraced the rationale immediately. Valuing the importance of communication as clinical skill and embracing the interdependence between communication and thought processes related to clinical reasoning and medical problem solving will be beneficial in teaching programs. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Hodgkin lymphoma in children, adolescents and young adults - a comparative study of clinical presentation and treatment outcome.

Science.gov (United States)

Englund, Annika; Glimelius, Ingrid; Rostgaard, Klaus; Smedby, Karin E; Eloranta, Sandra; Molin, Daniel; Kuusk, Thomas; Brown, Peter de Nully; Kamper, Peter; Hjalgrim, Henrik; Ljungman, Gustaf; Hjalgrim, Lisa Lyngsie

2018-02-01

Hodgkin lymphoma (HL) treatment protocols for children, adolescents and young adults traditionally differ, but the biological and clinical justification for this remains uncertain. We compared age-dependent clinical presentation and treatment and outcome for 1072 classical HL patients 0-24 years diagnosed in Denmark (1990-2010) and Sweden (1992-2009) in pediatric (n = 315, Denmark clinical characteristics was assessed with Pearson's chi 2 -test and Mantel-Haenszel trend test. The Kaplan-Meier method was used for survival analyses. Hazard ratios (HR) were used to compare the different treatment groups and calculated using Cox regression. Children (0-9 years) less often presented with advanced disease than adolescents (10-17 years) and young adults (18-24 years) (stage IIB-IV: children 32% vs. adolescents 50%, and adults 55%; p clinical presentation suggesting a rationale of harmonized treatment for these groups. Both adult and pediatric protocols provided high OS with no significant difference between the departments. The less frequent use of radiotherapy in Danish pediatric patients corresponded to a lower EFS, but comparable OS in all groups confirmed effective rescue strategies for the relapsing patients.

Rationale and Study Protocol for a Multi-component Health Information Technology (HIT) Screening Tool for Depression and Post-traumatic Stress Disorder in the Primary Care Setting

Science.gov (United States)

Biegler, Kelly; Mollica, Richard; Sim, Susan Elliott; Nicholas, Elisa; Chandler, Maria; Ngo-Metzger, Quyen; Paigne, Kittya; Paigne, Sompia; Nguyen, Danh V.; Sorkin, Dara H.

2016-01-01

The prevalence rate of depression in primary care is high. Primary care providers serve as the initial point of contact for the majority of patients with depression, yet, approximately 50% of cases remain unrecognized. The under-diagnosis of depression may be further exacerbated in limited English-language proficient (LEP) populations. Language barriers may result in less discussion of patients’ mental health needs and fewer referrals to mental health services, particularly given competing priorities of other medical conditions and providers’ time pressures. Recent advances in Health Information Technology (HIT) may facilitate novel ways to screen for depression in LEP populations. The purpose of this paper is to describe the rationale and protocol of a clustered-randomized controlled trial that will test the effectiveness of an HIT intervention that provides a multi-component approach to delivering culturally competent, mental health care in the primary care setting. The HIT intervention has four components: 1) web-based provider training, 2) multimedia electronic screening of depression and PTSD in the patients’ primary language, 3) Computer generated risk assessment scores delivered directly to the provider, and 4) clinical decision support. The outcomes of the study include assessing the potential of the HIT intervention to improve screening rates, clinical detection, provider initiation of treatment, and patient outcomes for depression and PTSD among LEP Cambodian refugees who experienced war atrocities and trauma during the Khmer Rouge. This technology has the potential to be adapted to any LEP population in order to facilitate mental health screening and treatment in the primary care setting. PMID:27394385

A method for extracting design rationale knowledge based on Text Mining

Directory of Open Access Journals (Sweden)

Liu Jihong

2017-01-01

Full Text Available Capture design rationale (DR knowledge and presenting it to designers by good form, which have great significance for design reuse and design innovation. Since the 1970s design rationality began to develop, many teams have developed their own design rational system. However, the DR acquisition system is not intelligent enough, and it still requires designers to do a lot of operations. In addition, the existing design documents contain a large number of DR knowledge, but it has not been well excavated. Therefore, a method and system are needed to better extract DR knowledge in design documents. We have proposed a DRKH (design rationale knowledge hierarchy model for DR representation. The DRKH model has three layers, respectively as design intent layer, design decision layer and design basis layer. In this paper, we use text mining method to extract DR from design documents and construct DR model. Finally, the welding robot design specification is taken as an example to demonstrate the system interface.

Percutaneous MR-Guided Cryoablation of Morton’s Neuroma: Rationale and Technical Details After the First 20 Patients

International Nuclear Information System (INIS)

Cazzato, Roberto Luigi; Garnon, Julien; Ramamurthy, Nitin; Tsoumakidou, Georgia; Caudrelier, Jean; Thenint, Marie-Aude; Rao, Pramod; Koch, Guillaume; Gangi, Afshin

2016-01-01

ObjectivesThe purpose of this study is to discuss technical aspects and rationales of magnetic resonance (MR)-guided cryoablation (CA) of Morton’s neuroma (MN); preliminary clinical experience is also retrospectively reviewed.MethodsProcedures were performed under local anaesthesia on an outpatient basis. Lesion size and location, procedural (technical success, procedural time, complications) and clinical outcomes (patient satisfaction according to a four-point scale, residual pain according to a 0–10 visual analogue scale and instances of “stump neuroma”) were assessed via chart review and cross-sectional telephone survey after the 20th case.ResultsTwenty patients (15 female, 5 male; mean age 50.3 years) were included; 24 MN (mean size 12.7 mm) were treated. Technical success was 100 %. Mean procedural time was 40.9 ± 10.4 min (range 35–60). One minor complication (superficial cellulitis) was reported (4.2 %). Follow-up (mean 19.7 months) was available for 18/24 MN. Patient satisfaction on a per-lesion basis was as follows: “completely satisfied” in 77.7 %, “satisfied with minor reservations” in 16.6 % and “satisfied with major reservations” in 5.7 % of cases. Mean pain score at last follow-up post-CA was 3.0. No instances of “stump neuroma” were reported.ConclusionsMR-guided CA of MN is a novel therapy which appears technically feasible. Clinical advantages of the procedure are high patient satisfaction, reduced risk of “stump neuroma” syndrome and good patient tolerance on an outpatient basis. Further, prospective studies are needed to confirm these encouraging results.

Percutaneous MR-Guided Cryoablation of Morton’s Neuroma: Rationale and Technical Details After the First 20 Patients

Energy Technology Data Exchange (ETDEWEB)

Cazzato, Roberto Luigi, E-mail: gigicazzato@hotmail.it; Garnon, Julien [Hôpitaux Universitaires de Strasbourg, HUS (France); Department of Interventional Radiology, Nouvel Hôpital Civil (France); Ramamurthy, Nitin [Norfolk and Norwich University Hospital, Department of Radiology (United Kingdom); Tsoumakidou, Georgia; Caudrelier, Jean; Thenint, Marie-Aude; Rao, Pramod; Koch, Guillaume; Gangi, Afshin [Hôpitaux Universitaires de Strasbourg, HUS (France); Department of Interventional Radiology, Nouvel Hôpital Civil (France)

2016-10-15

ObjectivesThe purpose of this study is to discuss technical aspects and rationales of magnetic resonance (MR)-guided cryoablation (CA) of Morton’s neuroma (MN); preliminary clinical experience is also retrospectively reviewed.MethodsProcedures were performed under local anaesthesia on an outpatient basis. Lesion size and location, procedural (technical success, procedural time, complications) and clinical outcomes (patient satisfaction according to a four-point scale, residual pain according to a 0–10 visual analogue scale and instances of “stump neuroma”) were assessed via chart review and cross-sectional telephone survey after the 20th case.ResultsTwenty patients (15 female, 5 male; mean age 50.3 years) were included; 24 MN (mean size 12.7 mm) were treated. Technical success was 100 %. Mean procedural time was 40.9 ± 10.4 min (range 35–60). One minor complication (superficial cellulitis) was reported (4.2 %). Follow-up (mean 19.7 months) was available for 18/24 MN. Patient satisfaction on a per-lesion basis was as follows: “completely satisfied” in 77.7 %, “satisfied with minor reservations” in 16.6 % and “satisfied with major reservations” in 5.7 % of cases. Mean pain score at last follow-up post-CA was 3.0. No instances of “stump neuroma” were reported.ConclusionsMR-guided CA of MN is a novel therapy which appears technically feasible. Clinical advantages of the procedure are high patient satisfaction, reduced risk of “stump neuroma” syndrome and good patient tolerance on an outpatient basis. Further, prospective studies are needed to confirm these encouraging results.

Conflicting rationales: leader's experienced ethical challenges in community health care for older people.

Science.gov (United States)

Slettebø, Åshild; Skaar, Ragnhild; Brodtkorb, Kari; Skisland, Anne

2017-08-22

Ethical challenges arise in all types of care, and leaders need to be aware of how to resolve these challenges. Healthcare systems tend to be organised around medical conditions, and the patient is often faced with a series of uncoordinated visits to multiple specialties. Ideally, care should be organised around the patient's needs. The purpose of this article was to highlight some ethical challenges perceived by leaders with responsibility for management and service distribution, finance and ensuring quality of community health services for older people. This study had a qualitative design with a qualitative content analysis of one focus group with six leaders that met four times in total. Leaders from the community healthcare sector in one Norwegian municipality were included, representing both nursing homes and home-based health care. The study followed the intentions of the Declaration of Helsinki and standard ethical principles. The Norwegian Social Science Data Services approved the study. All participants voluntarily gave written informed consent. The main theme that emerged from this study was the ethical challenge leaders felt in the form of an inherent conflict between a caring rationale versus economic or technological rationales. Four categories emerged: (i) Management: quality versus economy; (ii) Prioritisation: fair distribution of healthcare services; (iii) Responsibility: considering individuals' needs versus the needs of the whole community; and (iv) Welfare technology: possibilities and challenges. Leaders' responsibilities in community health care for older people need to strike a balance between ethical principles in the management of limited resources. © 2017 Nordic College of Caring Science.

Rationale and Methodology of Reprogramming for Generation of Induced Pluripotent Stem Cells and Induced Neural Progenitor Cells

Directory of Open Access Journals (Sweden)

Zuojun Tian

2016-04-01

Full Text Available Great progress has been made regarding the capabilities to modify somatic cell fate ever since the technology for generation of induced pluripotent stem cells (iPSCs was discovered in 2006. Later, induced neural progenitor cells (iNPCs were generated from mouse and human cells, bypassing some of the concerns and risks of using iPSCs in neuroscience applications. To overcome the limitation of viral vector induced reprogramming, bioactive small molecules (SM have been explored to enhance the efficiency of reprogramming or even replace transcription factors (TFs, making the reprogrammed cells more amenable to clinical application. The chemical induced reprogramming process is a simple process from a technical perspective, but the choice of SM at each step is vital during the procedure. The mechanisms underlying cell transdifferentiation are still poorly understood, although, several experimental data and insights have indicated the rationale of cell reprogramming. The process begins with the forced expression of specific TFs or activation/inhibition of cell signaling pathways by bioactive chemicals in defined culture condition, which initiates the further reactivation of endogenous gene program and an optimal stoichiometric expression of the endogenous pluri- or multi-potency genes, and finally leads to the birth of reprogrammed cells such as iPSCs and iNPCs. In this review, we first outline the rationale and discuss the methodology of iPSCs and iNPCs in a stepwise manner; and then we also discuss the chemical-based reprogramming of iPSCs and iNPCs.

The Nutrition and Enjoyable Activity for Teen Girls (NEAT girls) randomized controlled trial for adolescent girls from disadvantaged secondary schools: rationale, study protocol, and baseline results

OpenAIRE

Okely Anthony D; Plotnikoff Ronald C; Collins Clare E; Dewar Deborah; Morgan Philip J; Lubans David R; Batterham Marijka J; Finn Tara; Callister Robin

2010-01-01

Abstract Background Child and adolescent obesity predisposes individuals to an increased risk of morbidity and mortality from a range of lifestyle diseases. Although there is some evidence to suggest that rates of pediatric obesity have leveled off in recent years, this has not been the case among youth from low socioeconomic backgrounds. The purpose of this paper is to report the rationale, study design and baseline findings of a school-based obesity prevention program for low-active adolesc...

Five Big, Big Five Issues : Rationale, Content, Structure, Status, and Crosscultural Assessment

NARCIS (Netherlands)

De Raad, Boele

1998-01-01

This article discusses the rationale, content, structure, status, and crosscultural assessment of the Big Five trait factors, focusing on topics of dispute and misunderstanding. Taxonomic restrictions of the original Big Five forerunner, the "Norman Five," are discussed, and criticisms regarding the

Hanford waste-form release and sediment interaction: A status report with rationale and recommendations for additional studies

International Nuclear Information System (INIS)

Serne, R.J.; Wood, M.I.

1990-05-01

This report documents the currently available geochemical data base for release and retardation for actual Hanford Site materials (wastes and/or sediments). The report also recommends specific laboratory tests and presents the rationale for the recommendations. The purpose of this document is threefold: to summarize currently available information, to provide a strategy for generating additional data, and to provide recommendations on specific data collection methods and tests matrices. This report outlines a data collection approach that relies on feedback from performance analyses to ascertain when adequate data have been collected. The data collection scheme emphasizes laboratory testing based on empiricism. 196 refs., 4 figs., 36 tabs

Texas Medication Algorithm Project, phase 3 (TMAP-3): rationale and study design.

Science.gov (United States)

Rush, A John; Crismon, M Lynn; Kashner, T Michael; Toprac, Marcia G; Carmody, Thomas J; Trivedi, Madhukar H; Suppes, Trisha; Miller, Alexander L; Biggs, Melanie M; Shores-Wilson, Kathy; Witte, Bradley P; Shon, Steven P; Rago, William V; Altshuler, Kenneth Z

2003-04-01

Medication treatment algorithms may improve clinical outcomes, uniformity of treatment, quality of care, and efficiency. However, such benefits have never been evaluated for patients with severe, persistent mental illnesses. This study compared clinical and economic outcomes of an algorithm-driven disease management program (ALGO) with treatment-as-usual (TAU) for adults with DSM-IV schizophrenia (SCZ), bipolar disorder (BD), and major depressive disorder (MDD) treated in public mental health outpatient clinics in Texas. The disorder-specific intervention ALGO included a consensually derived and feasibility-tested medication algorithm, a patient/family educational program, ongoing physician training and consultation, a uniform medical documentation system with routine assessment of symptoms and side effects at each clinic visit to guide ALGO implementation, and prompting by on-site clinical coordinators. A total of 19 clinics from 7 local authorities were matched by authority and urban status, such that 4 clinics each offered ALGO for only 1 disorder (SCZ, BD, or MDD). The remaining 7 TAU clinics offered no ALGO and thus served as controls (TAUnonALGO). To determine if ALGO for one disorder impacted care for another disorder within the same clinic ("culture effect"), additional TAU subjects were selected from 4 of the ALGO clinics offering ALGO for another disorder (TAUinALGO). Patient entry occurred over 13 months, beginning March 1998 and concluding with the final active patient visit in April 2000. Research outcomes assessed at baseline and periodically for at least 1 year included (1) symptoms, (2) functioning, (3) cognitive functioning (for SCZ), (4) medication side effects, (5) patient satisfaction, (6) physician satisfaction, (7) quality of life, (8) frequency of contacts with criminal justice and state welfare system, (9) mental health and medical service utilization and cost, and (10) alcohol and substance abuse and supplemental substance use information

Rationale of a quick adjustment method for crystal orientation in oscillation photography

International Nuclear Information System (INIS)

Suh, I.H.; Suh, J.M.; Ko, T.S.

1988-01-01

The rationale for a convenient crystal orientation method for oscillation photography is presented. The method involves the measurement of the deviations of reflection spots from the equator. These deviations are added or subtracted to give the horizontal and vertical arc corrections. (orig.)

Physician leadership development at Cleveland Clinic: a brief review.

Science.gov (United States)

Christensen, Terri; Stoller, James K

2016-06-01

We aim to describe the rationale for and spectrum of leadership development programs, highlighting experience at a large healthcare institution (Cleveland Clinic, Cleveland, Ohio, USA). Developing leaders is a universal priority to sustain organizational success. In health care, significant challenges of ensuring quality and access and making care affordable are widely shared internationally and demand effective physician leadership. Yet, leadership competencies differ from clinical and scientific competencies and features of selecting and training physicians-who have been called "heroic lone healers" -often conspire against physicians being effective leaders or followers. Thus, developing leadership competencies in physicians is critical.Leadership development programs have been signature features of successful organizations and various Australian organizations offer such training (e.g. The Australian Leadership Foundation and the University of South Australia), but relatively few health care organizations have adopted the practice of offering such training, both in Australia and elsewhere. As a United States example of one such integrated program, the Cleveland Clinic, a large, closed-staff physician-led group practice in Cleveland, Ohio has offered physician leadership training for over 15 years. This paper describes the rationale, structure, and some of the observed impacts associated with this program. © The Royal Australian and New Zealand College of Psychiatrists 2016.

Translation of New Molecular Imaging Approaches to the Clinical Setting: Bridging the Gap to Implementation.

Science.gov (United States)

van Es, Suzanne C; Venema, Clasina M; Glaudemans, Andor W J M; Lub-de Hooge, Marjolijn N; Elias, Sjoerd G; Boellaard, Ronald; Hospers, Geke A P; Schröder, Carolina P; de Vries, Elisabeth G E

2016-02-01

Molecular imaging with PET is a rapidly emerging technique. In breast cancer patients, more than 45 different PET tracers have been or are presently being tested. With a good rationale, after development of the tracer and proven feasibility, it is of interest to evaluate whether there is a potential meaningful role for the tracer in the clinical setting-such as in staging, in the (early) prediction of a treatment response, or in supporting drug choices. So far, only (18)F-FDG PET has been incorporated into breast cancer guidelines. For proof of the clinical relevance of tracers, especially for analysis in a multicenter setting, standardization of the technology and access to the novel PET tracer are required. However, resources for PET implementation research are limited. Therefore, next to randomized studies, novel approaches are required for proving the clinical value of PET tracers with the smallest possible number of patients. The aim of this review is to describe the process of the development of PET tracers and the level of evidence needed for the use of these tracers in breast cancer. Several breast cancer trials have been performed with the PET tracers (18)F-FDG, 3'-deoxy-3'-(18)F-fluorothymidine ((18)F-FLT), and (18)F-fluoroestradiol ((18)F-FES). We studied them to learn lessons for the implementation of novel tracers. After defining the gap between a good rationale for a tracer and implementation in the clinical setting, we propose solutions to fill the gap to try to bring more PET tracers to daily clinical practice. © 2016 by the Society of Nuclear Medicine and Molecular Imaging, Inc.

Maintaining the clinical relevance of animal models in translational studies of post-traumatic stress disorder.

Science.gov (United States)

Cohen, Hagit; Matar, Michael A; Zohar, Joseph

2014-01-01

The diagnosis of Post-Traumatic Stress Disorder (PTSD) is conditional on directly experiencing or witnessing a significantly threatening event and the presence of a certain minimal number of symptoms from each of four symptom clusters (re-experiencing, avoidance, negative cognition and mood, and hyperarousal) at least one month after the event (DSM 5) (American Psychiatric Association 2013). Only a proportion of the population exposed develops symptoms fulfilling the criteria. The individual heterogeneity in responses of stress-exposed animals suggested that adapting clearly defined and reliably reproducible "diagnostic", i.e. behavioral, criteria for animal responses would augment the clinical validity of the analysis of study data. We designed cut-off (inclusion/exclusion) behavioral criteria (CBC) which classify study subjects as being severely, minimally or partially affected by the stress paradigm, to be applied retrospectively in the analysis of behavioral data. Behavioral response classification enables the researcher to correlate (retrospectively) specific anatomic, bio-molecular and physiological parameters with the degree and pattern of the individual behavioral response, and also introduces "prevalence rates" as a valid study-parameter. The cumulative results of our studies indicate that, by classifying the data from individual subjects according to their response patterns, the animal study can more readily be translated into clinical "follow-up" studies and back again. This article will discuss the concept of the model and its background, and present a selection of studies employing and examining the model, alongside the underlying translational rationale of each. © The Author 2014. Published by Oxford University Press on behalf of the Institute for Laboratory Animal Research. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Malignant mesothelioma clinical trial combines immunotherapy drugs.

Science.gov (United States)

Chatwal, Monica S; Tanvetyanon, Tawee

2018-04-01

Immunotherapy by checkpoint inhibitor is effective for a number of solid tumors including malignant mesothelioma. Studies utilizing single-agent PD-1 or PD-L1 inhibitor for mesothelioma have reported tumor response rates in approximately 10-20% of patients treated. Given the success of combining these agents with CTLA-4 inhibitor in melanoma, there is a strong rationale to study it in mesothelioma. Recently results from clinical trials investigating this approach have been released. Though limited by small sample size, the studies conclusively demonstrated feasibility and suggested a modestly higher tumor response rate than one would expect from treatment with single-agent PD-1 or PD-L1 inhibitor. Nevertheless, toxicity was also increased. Immunotherapy-related deaths due to encephalitis, renal failure and hepatitis were observed. Further studies are warranted.

Advanced water-cooled reactor technologies. Rationale, state of progress and outlook

International Nuclear Information System (INIS)

Anon.

1989-01-01

Eighty per cent of the world's power reactors are water cooled and moderated. Many improvements in their design and operation have been implemented since the first such reactor started commercial operation in 1957. This report addresses the safety, environmental and economic rationales for further improvements, as well as their relevance to currently operating water reactors

Rationale and study protocol for a multi-component Health Information Technology (HIT) screening tool for depression and post-traumatic stress disorder in the primary care setting.

Science.gov (United States)

Biegler, Kelly; Mollica, Richard; Sim, Susan Elliott; Nicholas, Elisa; Chandler, Maria; Ngo-Metzger, Quyen; Paigne, Kittya; Paigne, Sompia; Nguyen, Danh V; Sorkin, Dara H

2016-09-01

The prevalence rate of depression in primary care is high. Primary care providers serve as the initial point of contact for the majority of patients with depression, yet, approximately 50% of cases remain unrecognized. The under-diagnosis of depression may be further exacerbated in limited English-language proficient (LEP) populations. Language barriers may result in less discussion of patients' mental health needs and fewer referrals to mental health services, particularly given competing priorities of other medical conditions and providers' time pressures. Recent advances in Health Information Technology (HIT) may facilitate novel ways to screen for depression and other mental health disorders in LEP populations. The purpose of this paper is to describe the rationale and protocol of a clustered randomized controlled trial that will test the effectiveness of an HIT intervention that provides a multi-component approach to delivering culturally competent, mental health care in the primary care setting. The HIT intervention has four components: 1) web-based provider training, 2) multimedia electronic screening of depression and PTSD in the patients' primary language, 3) Computer generated risk assessment scores delivered directly to the provider, and 4) clinical decision support. The outcomes of the study include assessing the potential of the HIT intervention to improve screening rates, clinical detection, provider initiation of treatment, and patient outcomes for depression and post-traumatic stress disorder (PTSD) among LEP Cambodian refugees who experienced war atrocities and trauma during the Khmer Rouge. This technology has the potential to be adapted to any LEP population in order to facilitate mental health screening and treatment in the primary care setting. Copyright © 2016 Elsevier Inc. All rights reserved.

A comparative study: classification vs. user-based collaborative filtering for clinical prediction.

Science.gov (United States)

Hao, Fang; Blair, Rachael Hageman

2016-12-08

Recommender systems have shown tremendous value for the prediction of personalized item recommendations for individuals in a variety of settings (e.g., marketing, e-commerce, etc.). User-based collaborative filtering is a popular recommender system, which leverages an individuals' prior satisfaction with items, as well as the satisfaction of individuals that are "similar". Recently, there have been applications of collaborative filtering based recommender systems for clinical risk prediction. In these applications, individuals represent patients, and items represent clinical data, which includes an outcome. Application of recommender systems to a problem of this type requires the recasting a supervised learning problem as unsupervised. The rationale is that patients with similar clinical features carry a similar disease risk. As the "Big Data" era progresses, it is likely that approaches of this type will be reached for as biomedical data continues to grow in both size and complexity (e.g., electronic health records). In the present study, we set out to understand and assess the performance of recommender systems in a controlled yet realistic setting. User-based collaborative filtering recommender systems are compared to logistic regression and random forests with different types of imputation and varying amounts of missingness on four different publicly available medical data sets: National Health and Nutrition Examination Survey (NHANES, 2011-2012 on Obesity), Study to Understand Prognoses Preferences Outcomes and Risks of Treatment (SUPPORT), chronic kidney disease, and dermatology data. We also examined performance using simulated data with observations that are Missing At Random (MAR) or Missing Completely At Random (MCAR) under various degrees of missingness and levels of class imbalance in the response variable. Our results demonstrate that user-based collaborative filtering is consistently inferior to logistic regression and random forests with different

A comparative study: classification vs. user-based collaborative filtering for clinical prediction

Directory of Open Access Journals (Sweden)

Fang Hao

2016-12-01

Full Text Available Abstract Background Recommender systems have shown tremendous value for the prediction of personalized item recommendations for individuals in a variety of settings (e.g., marketing, e-commerce, etc.. User-based collaborative filtering is a popular recommender system, which leverages an individuals’ prior satisfaction with items, as well as the satisfaction of individuals that are “similar”. Recently, there have been applications of collaborative filtering based recommender systems for clinical risk prediction. In these applications, individuals represent patients, and items represent clinical data, which includes an outcome. Methods Application of recommender systems to a problem of this type requires the recasting a supervised learning problem as unsupervised. The rationale is that patients with similar clinical features carry a similar disease risk. As the “Big Data” era progresses, it is likely that approaches of this type will be reached for as biomedical data continues to grow in both size and complexity (e.g., electronic health records. In the present study, we set out to understand and assess the performance of recommender systems in a controlled yet realistic setting. User-based collaborative filtering recommender systems are compared to logistic regression and random forests with different types of imputation and varying amounts of missingness on four different publicly available medical data sets: National Health and Nutrition Examination Survey (NHANES, 2011-2012 on Obesity, Study to Understand Prognoses Preferences Outcomes and Risks of Treatment (SUPPORT, chronic kidney disease, and dermatology data. We also examined performance using simulated data with observations that are Missing At Random (MAR or Missing Completely At Random (MCAR under various degrees of missingness and levels of class imbalance in the response variable. Results Our results demonstrate that user-based collaborative filtering is consistently inferior

Seeing Students Squirm: Nursing Students’ Experiences of Bullying Behaviors During Clinical Rotations

Science.gov (United States)

Smith, Carolyn R.; Gillespie, Gordon Lee; Brown, Kathryn C.; Grubb, Paula L.

2016-01-01

Background Bullying remains a troubling problem in the nursing profession. Nursing students may encounter bullying behavior in clinical settings. However nursing students may not be adequately prepared to recognize and handle bullying behavior when it occurs. The purpose of this study was to gain greater understanding of nursing students’ experiences of bullying behaviors in the clinical setting. Method Using a descriptive qualitative approach, eight focus groups were held with 56 undergraduate baccalaureate nursing students from four college campuses. Focus group data were coded and analyzed for themes. Results Four categories of themes were identified: bullying behaviors, rationale for bullying, response to bullying, and recommendations to address bullying. Each category and its corresponding themes are presented. Conclusion Interventions for nurse educators to address bullying of nursing students in clinical settings are presented. PMID:27560118

Randomized placebo controlled blinded study to assess valsartan efficacy in preventing left ventricle remodeling in patients with dual chamber pacemaker--Rationale and design of the trial.

Science.gov (United States)

Tomasik, Andrzej; Jacheć, Wojciech; Wojciechowska, Celina; Kawecki, Damian; Białkowska, Beata; Romuk, Ewa; Gabrysiak, Artur; Birkner, Ewa; Kalarus, Zbigniew; Nowalany-Kozielska, Ewa

2015-05-01

Dual chamber pacing is known to have detrimental effect on cardiac performance and heart failure occurring eventually is associated with increased mortality. Experimental studies of pacing in dogs have shown contractile dyssynchrony leading to diffuse alterations in extracellular matrix. In parallel, studies on experimental ischemia/reperfusion injury have shown efficacy of valsartan to inhibit activity of matrix metalloproteinase-9, to increase the activity of tissue inhibitor of matrix metalloproteinase-3 and preserve global contractility and left ventricle ejection fraction. To present rationale and design of randomized blinded trial aimed to assess whether 12 month long administration of valsartan will prevent left ventricle remodeling in patients with preserved left ventricle ejection fraction (LVEF ≥ 40%) and first implantation of dual chamber pacemaker. A total of 100 eligible patients will be randomized into three parallel arms: placebo, valsartan 80 mg/daily and valsartan 160 mg/daily added to previously used drugs. The primary endpoint will be assessment of valsartan efficacy to prevent left ventricle remodeling during 12 month follow-up. We assess patients' functional capacity, blood plasma activity of matrix metalloproteinases and their tissue inhibitors, NT-proBNP, tumor necrosis factor alpha, and Troponin T. Left ventricle function and remodeling is assessed echocardiographically: M-mode, B-mode, tissue Doppler imaging. If valsartan proves effective, it will be an attractive measure to improve long term prognosis in aging population and increasing number of pacemaker recipients. ClinicalTrials.org (NCT01805804). Copyright © 2015 Elsevier Inc. All rights reserved.

Assessment of diagnostic technology in health care: rationale, methods, problems, and directions

National Research Council Canada - National Science Library

Sox, Harold C

1989-01-01

... Rationale, Methods, Problems, and Directions Harold Sox, Susan Stern, Douglas Owens, and Herbert L. Abrams Institute of Medicine NATIONAL ACADEMY PRESS WASHINGTON, D.C. 1989 Copyrightthe cannot be not from book, paper however, version for formatting, original authoritative the typesetting-specific the as from created publication files XML from...

Applying self-determination theory for improved understanding of physiotherapists' rationale for using research in clinical practice: a qualitative study in Sweden.

Science.gov (United States)

Dannapfel, Petra; Peolsson, Anneli; Ståhl, Christian; Öberg, Birgitta; Nilsen, Per

2014-01-01

Physiotherapists are generally positive to evidence-based practice (EBP) and the use of research in clinical practice, yet many still base clinical decisions on knowledge obtained during their initial education and/or personal experience. Our aim was to explore motivations behind physiotherapists' use of research in clinical practice. Self-Determination Theory was applied to identify the different types of motivation for use of research. This theory posits that all behaviours lie along a continuum of relative autonomy, reflecting the extent to which a person endorses their actions. Eleven focus group interviews were conducted, involving 45 physiotherapists in various settings in Sweden. Data were analysed using qualitative content analysis and the findings compared with Self-Determination Theory using a deductive approach. Motivations underlying physiotherapists use of research in clinical practice were identified. Most physiotherapists expressed autonomous forms of motivation for research use, but some exhibited more controlled motivation. Several implications about how more evidence-based physiotherapy can be achieved are discussed, including the potential to tailor educational programs on EBP to better account for differences in motivation among participants, using autonomously motivated physiotherapists as change agents and creating favourable conditions to encourage autonomous motivation by way of feelings of competence, autonomy and a sense of relatedness.

Neridronate: From Experimental Data to Clinical Use

Directory of Open Access Journals (Sweden)

Addolorata Corrado

2017-09-01

Full Text Available Neridronate is an amino-bisphosphonate that has been officially approved as a treatment for osteogenesis imperfecta, Paget’s disease of bone and type I complex regional pain syndrome in Italy. Neridronate is administered either intravenously or intramuscularly; thus, it represents a valid option for both cases with contraindications to the use of oral bisphosphonates and cases with contraindications or an inability to receive an intravenous administration of these drugs. Furthermore, although the official authorized use of neridronate is limited to only 3 bone diseases, many experimental and clinical studies support the rationale for its use and provide evidence of its effectiveness in other pathologic bone conditions that are characterized by altered bone remodelling.

The role of Amazonian anthropogenic soils in shifting cultivation: learning from farmers’ rationales

NARCIS (Netherlands)

Braga Junqueira, A.; Almekinders, C.J.M.; Stomph, T.J.; Clement, C.R.; Struik, P.C.

2016-01-01

We evaluated farmers’ rationales to understand their decision making in relation to the use of fertile anthropogenic soils, i.e., Amazonian dark earths (ADE), and for dealing with changes in shifting cultivation in Central Amazonia. We analyzed qualitative information from 196 interviews with

Study protocol and rationale for a randomized double-blinded crossover trial of phentermine-topiramate ER versus placebo to treat binge eating disorder and bulimia nervosa.

Science.gov (United States)

Dalai, Shebani Sethi; Adler, Sarah; Najarian, Thomas; Safer, Debra Lynn

2018-01-01

Bulimia nervosa (BN) and binge eating disorder (BED) are associated with severe psychological and medical consequences. Current therapies are limited, leaving up to 50% of patients symptomatic despite treatment, underscoring the need for additional treatment options. Qsymia, an FDA-approved medication for obesity, combines phentermine and topiramate ER. Topiramate has demonstrated efficacy for both BED and BN, but limited tolerability. Phentermine is FDA-approved for weight loss. A rationale for combined phentermine/topiramate for BED and BN is improved tolerability and efficacy. While a prior case series exploring Qsymia for BED showed promise, randomized studies are needed to evaluate Qsymia's safety and efficacy when re-purposed in eating disorders. We present a study protocol for a Phase I/IIa single-center, prospective, double-blinded, randomized, crossover trial examining safety and preliminary efficacy of Qsymia for BED and BN. Adults with BED (n=15) or BN (n=15) are randomized 1:1 to receive 12weeks Qsymia (phentermine/topiramate ER, 3.75mg/23mg-15mg/92mg) or placebo, followed by 2-weeks washout and 12-weeks crossover, where those on Qsymia receive placebo and vice versa. Subsequently participants receive 8weeks follow-up off study medications. The primary outcome is the number of binge days/week measured by EDE. Secondary outcomes include average number of binge episodes, percentage abstinence from binge eating, and changes in weight/vitals, eating psychopathology, and mood. To our knowledge this is the first randomized, double-blind protocol investigating the safety and efficacy of phentermine/topiramate in BED and BN. We highlight the background and rationale for this study, including the advantages of a crossover design. Clinicaltrials.gov identifier NCT02553824 registered on 9/17/2015. https://clinicaltrials.gov/ct2/show/NCT02553824. Copyright © 2017 Elsevier Inc. All rights reserved.

Fostering clinical reasoning in physiotherapy: comparing the effects of concept map study and concept map completion after example study in novice and advanced learners.

Science.gov (United States)

Montpetit-Tourangeau, Katherine; Dyer, Joseph-Omer; Hudon, Anne; Windsor, Monica; Charlin, Bernard; Mamede, Sílvia; van Gog, Tamara

2017-12-01

Health profession learners can foster clinical reasoning by studying worked examples presenting fully worked out solutions to a clinical problem. It is possible to improve the learning effect of these worked examples by combining them with other learning activities based on concept maps. This study investigated which combinaison of activities, worked examples study with concept map completion or worked examples study with concept map study, fosters more meaningful learning of intervention knowledge in physiotherapy students. Moreover, this study compared the learning effects of these learning activity combinations between novice and advanced learners. Sixty-one second-year physiotherapy students participated in the study which included a pre-test phase, a 130-min guided-learning phase and a four-week self-study phase. During the guided and self-study learning sessions, participants had to study three written worked examples presenting the clinical reasoning for selecting electrotherapeutic currents to treat patients with motor deficits. After each example, participants engaged in either concept map completion or concept map study depending on which learning condition they were randomly allocated to. Students participated in an immediate post-test at the end of the guided-learning phase and a delayed post-test at the end of the self-study phase. Post-tests assessed the understanding of principles governing the domain of knowledge to be learned (conceptual knowledge) and the ability to solve new problems that have similar (i.e., near transfer) or different (i.e., far transfer) solution rationales as problems previously studied in the examples. Learners engaged in concept map completion outperformed those engaged in concept map study on near transfer (p = .010) and far transfer (p concept map completion led to greater transfer performance than worked examples study combined with concept map study for both novice and advanced learners. Concept map completion

Clinical and Biological Predictors of Plasma Levels of Soluble RAGE in Critically Ill Patients: Secondary Analysis of a Prospective Multicenter Observational Study

Directory of Open Access Journals (Sweden)

Thibaut Pranal

2018-01-01

Full Text Available Rationale. Although soluble forms of the receptor for advanced glycation end products (RAGE have been recently proposed as biomarkers in multiple acute or chronic diseases, few studies evaluated the influence of usual clinical and biological parameters, or of patient characteristics and comorbidities, on circulating levels of soluble RAGE in the intensive care unit (ICU setting. Objectives. To determine, among clinical and biological parameters that are usually recorded upon ICU admission, which variables, if any, could be associated with plasma levels of soluble RAGE. Methods. Data for this ancillary study were prospectively obtained from adult patients with at least one ARDS risk factor upon ICU admission enrolled in a large multicenter observational study. At ICU admission, plasma levels of total soluble RAGE (sRAGE and endogenous secretory (esRAGE were measured by duplicate ELISA and baseline patient characteristics, comorbidities, and usual clinical and biological indices were recorded. After univariate analyses, significant variables were used in multivariate, multidimensional analyses. Measurements and Main Results. 294 patients were included in this ancillary study, among whom 62% were admitted for medical reasons, including septic shock (11%, coma (11%, and pneumonia (6%. Although some variables were associated with plasma levels of RAGE soluble forms in univariate analysis, multidimensional analyses showed no significant association between admission parameters and baseline plasma sRAGE or esRAGE. Conclusions. We found no obvious association between circulating levels of soluble RAGE and clinical and biological indices that are usually recorded upon ICU admission. This trial is registered with NCT02070536.

Radiosensitizers: rationale and potential

International Nuclear Information System (INIS)

Brown, J.M.

1981-01-01

This paper briefly reviews agents that are capable of sensitizing hypoxic cells to radiation and chemotherapeutic agents. The first part is a synopsis of the development of hypoxic radiosensitizers, which concludes that misonidazole can be effective against human tumors. Unfortunately, neurotoxicity limits its effectiveness in humans because the dose that can be given in conjunction with daily fractionated radiation is five to ten times lower than is required for full radiosensitization of the hypoxic cells. The second part covers our recent efforts to develop a drug that does not produce such limiting neurotoxicity. The primary rationale of our program was to synthesize a drug with a short plasma half-life that was too hydrophilic to cross the blood-brain barrier but was able to penetrate tumors and radiosensitize hypoxic cells. From this program, a new drug, SR-2508, has been found that is as efficient as misonidazole in its radiosensitizing ability, but is four to ten times less toxic. Finally, the potential of radiosensitizers not only as agents that can sensitize tumor cells to radiation, but also as agents that can specifically sensitize tumors to chemotherapeutic agents, is discussed. In addition, these drugs may be potential cytotoxic agents that produce toxicity only in solid tumors

Legitimizing Technical Communication in English Departments: Carolyn Miller's "Humanistic Rationale for Technical Writing"

Science.gov (United States)

Moore, Patrick

2006-01-01

Carolyn Miller's oft-cited "Humanistic Rationale for Technical Writing," published in 1979, tries to give technical communication faculty more cultural capital in English departments controlled by literature professors. Miller replaces a positivistic emphasis in technical communication pedagogy with rhetoric. She shows how technical knowledge is…

Plato's Cosmic Theology: A Rationale for a Polytheistic Astrology?

Science.gov (United States)

Henriques, André

2015-05-01

Plato's cosmology influenced classical astronomy and religion, but was in turn influenced by the polytheistic context of its time. Throughout his texts, including the cosmological treatise Timaeus, and the discussions on the soul in the Phaedrus, Plato (c.428-c.348 BC) established what can be generalised as Platonic cosmological thought. An understanding of the philosophical and mythical levels of Platonic thought can provide a rationale for polytheistic and astrological worldviews, pointing to some cosmological continuity, alongside major shifts, from ancient Greek religion to the astrological thought of ancient astronomers such as Claudius Ptolemy.

The Strathclyde Evaluation of Children's Active Travel (SE-CAT: study rationale and methods

Directory of Open Access Journals (Sweden)

McMinn David

2011-12-01

Full Text Available Abstract Background The school commute is a prime opportunity to increase children's physical activity levels. However, active commuting has decreased over the past 40 years. Strategies that increase walking to school are therefore needed. Travelling Green (TG is a school-based active travel resource aimed at increasing children's walking to school. The resource consists of a curriculum-based program of lessons and goal setting activities. A previous study found that children who received the TG intervention increased self-reported distance travelled to school by active modes and reduced the distance travelled by inactive modes. This study was limited by self-reported outcome measures, a small sample, and no follow-up measures. A more robust evaluation of TG is required to address these limitations. This paper describes the rationale and methods for such an evaluation of Travelling Green, and describes the piloting of various active commuting measures in primary school children. Methods/Design Measures of active commuting were piloted in a sample of 26 children (aged 8-9 years over one school week. These measures were subsequently used in an 18-month quasi-experimental design to evaluate the effect of TG on commuting behaviour. Participants were 166 children (60% male aged 8-9 years from 5 primary schools. Two schools (n = 79 children received TG in September/October 2009. Three schools (n = 87 children acted as a comparison group, and subsequently received TG at a later date. Physical activity was measured using Actigraph GT1M accelerometers. Personal and environmental determinants of active commuting were measured via parent and child questionnaires, as were factors related to the Theory of Planned Behaviour and the construct of habit. Measures were taken pre- and post-intervention and at 5 and 12 months follow-up. Discussion The piloted protocol was practical and feasible and piloted measures were reliable and valid. All study data, including

Rationale for single molecule detection by means of Raman spectroscopy

International Nuclear Information System (INIS)

Gaponenko, S.V.; Guzatov, D.V.

2009-01-01

A consistent quantum electrodynamical description is proposed of Raman scattering of light by a molecule in a medium with a modified photon density of states. Enhanced local density of states near a metal nanobody is shown to increase a scattering rate by several orders of magnitude, thus providing a rationale for experimental detection of single molecules by means of Raman spectroscopy. For an ellipsoidal particle 10 14 -fold enhancement of the Raman scattering cross-section is obtained. (authors)

Exercise intolerance in pulmonary hypertension: mechanism, evaluation and clinical implications.

Science.gov (United States)

Babu, Abraham Samuel; Arena, Ross; Myers, Jonathan; Padmakumar, Ramachandran; Maiya, Arun G; Cahalin, Lawrence P; Waxman, Aaron B; Lavie, Carl J

2016-09-01

Exercise intolerance in pulmonary hypertension (PH) is a major factor affecting activities of daily living and quality of life. Evaluation strategies (i.e., non-invasive and invasive tests) are integral to providing a comprehensive assessment of clinical and functional status. Despite a growing body of literature on the clinical consequences of PH, there are limited studies discussing the contribution of various physiological systems to exercise intolerance in this patient population. This review, through a search of various databases, describes the physiological basis for exercise intolerance across the various PH etiologies, highlights the various exercise evaluation methods and discusses the rationale for exercise training amongst those diagnosed with PH. Expert commentary: With the growing importance of evaluating exercise capacity in PH (class 1, Level C recommendation), understanding why exercise performance is altered in PH is crucial. Thus, the further study is required for better quality evidence in this area.

Methods for a multicenter randomized trial for mixed urinary incontinence: rationale and patient-centeredness of the ESTEEM trial

Science.gov (United States)

Sung, Vivian W.; Borello-France, Diane; Dunivan, Gena; Gantz, Marie; Lukacz, Emily S.; Moalli, Pamela; Newman, Diane K.; Richter, Holly E.; Ridgeway, Beri; Smith, Ariana L.; Weidner, Alison C.; Meikle, Susan

2016-01-01

Introduction Mixed urinary incontinence (MUI) can be a challenging condition to manage. We describe the protocol design and rationale for the Effects of Surgical Treatment Enhanced with Exercise for Mixed Urinary Incontinence (ESTEEM) trial, designed to compare a combined conservative and surgical treatment approach versus surgery alone for improving patient-centered MUI outcomes at 12 months. Methods ESTEEM is a multi-site, prospective, randomized trial of female participants with MUI randomized to a standardized perioperative behavioral/pelvic floor exercise intervention plus midurethral sling versus midurethral sling alone. We describe our methods and four challenges encountered during the design phase: defining the study population, selecting relevant patient-centered outcomes, determining sample size estimates using a patient-reported outcome measure, and designing an analysis plan that accommodates MUI failure rates. A central theme in the design was patient-centeredness, which guided many key decisions. Our primary outcome is patient-reported MUI symptoms measured using the Urogenital Distress Inventory (UDI) score at 12 months. Secondary outcomes include quality of life, sexual function, cost-effectiveness, time to failure and need for additional treatment. Results The final study design was implemented in November 2013 across 8 clinical sites in the Pelvic Floor Disorders Network. As of February 27, 2016, 433 total /472 targeted participants have been randomized. Conclusions We describe the ESTEEM protocol and our methods for reaching consensus for methodological challenges in designing a trial for MUI by maintaining the patient perspective at the core of key decisions. This trial will provide information that can directly impact patient care and clinical decision-making. PMID:27287818

Study design and rationale of "Synergistic Effect of Combination Therapy with Cilostazol and ProbUcol on Plaque Stabilization and Lesion REgression (SECURE" study: a double-blind randomised controlled multicenter clinical trial

Directory of Open Access Journals (Sweden)

Lee Myoungsook

2011-01-01

Full Text Available Abstract Background Probucol, a cholesterol-lowering agent that paradoxically also lowers high-density lipoprotein cholesterol has been shown to prevent progression of atherosclerosis. The antiplatelet agent cilostazol, which has diverse antiatherogenic properties, has also been shown to reduce restenosis in previous clinical trials. Recent experimental studies have suggested potential synergy between probucol and cilostazol in preventing atherosclerosis, possibly by suppressing inflammatory reactions and promoting cholesterol efflux. Methods/design The Synergistic Effect of combination therapy with Cilostazol and probUcol on plaque stabilization and lesion REgression (SECURE study is designed as a double-blind, randomised, controlled, multicenter clinical trial to investigate the effect of cilostazol and probucol combination therapy on plaque volume and composition in comparison with cilostazol monotherapy using intravascular ultrasound and Virtual Histology. The primary end point is the change in the plaque volume of index intermediate lesions between baseline and 9-month follow-up. Secondary endpoints include change in plaque composition, neointimal growth after implantation of stents at percutaneous coronary intervention target lesions, and serum levels of lipid components and biomarkers related to atherosclerosis and inflammation. A total of 118 patients will be included in the study. Discussion The SECURE study will deliver important information on the effects of combination therapy on lipid composition and biomarkers related to atherosclerosis, thereby providing insight into the mechanisms underlying the prevention of atherosclerosis progression by cilostazol and probucol. Trial registration number ClinicalTrials (NCT: NCT01031667

Rationale for energy research and development programme

Energy Technology Data Exchange (ETDEWEB)

1976-04-01

This paper describes the rationale for the expenditure of government money on energy research and development. The Committee, organized in 1974, established the following order of project priorities: projects to determine current and future energy demand; projects concerned with the conservation and more efficient use of energy; projects concerned with the assessment of indigenous energy resources; projects concerned with the assessment of the human, financial, and organizational resources for energy production and use; and projects concerned with economic, technological, social, and environmental aspects of energy use and production over the next 15 years and beyond the next 15 years. Significant factors affecting the national energy economy, the strategy for energy research and development, and the results of committee activities are summarized. An energy scenario research is laid out. (MCW)

Proposed energy conservation contingency plan: emergency restrictions on advertising lighting. Authorities, need, rationale, and operation

Energy Technology Data Exchange (ETDEWEB)

1977-04-01

The emergency restrictions on advertising lighting proposed in Energy Conservation Contingency Plan No. 5 of 1977 are presented. A statement is given on the need for rationale and operation of the Contingency Plan.

Targeting dormant micrometastases: rationale, evidence to date and clinical implications.

Science.gov (United States)

Hurst, Robert E; Bastian, Anja; Bailey-Downs, Lora; Ihnat, Michael A

2016-03-01

In spite of decades of research, cancer survival has increased only modestly. This is because most research is based on models of primary tumors. Slow recognition has begun that disseminated, dormant cancer cells (micrometastatic cells) that are generally resistant to chemotherapy are the culprits in recurrence, and until these are targeted effectively we can expect only slow progress in increasing overall survival from cancer. This paper reviews efforts to understand the mechanisms by which cancer cells can become dormant, and thereby identify potential targets and drugs either on the market or in clinical trials that purport to prevent metastasis. This review targets the most recent literature because several excellent reviews have covered the literature from more than two years ago. The paper also describes recent work in the authors' laboratories to develop a screening-based approach that does not require understanding of mechanisms of action or the molecular target. Success of this approach shows that targeting micrometastatic cells is definitely feasible.

The rationale for early intervention in schizophrenia and related disorders

DEFF Research Database (Denmark)

Nordentoft, Merete; Jeppesen, Pia; Petersen, Lone

2009-01-01

, adherence to treatment, comorbid drug abuse, relapse and readmission. Some benefits persist after cessation of the intervention. Conclusions: Early intervention in schizophrenia is justified to reduce the negative personal and social impact of prolonged periods of untreated symptoms. Furthermore, phase......Abstract Aim: To examine the rationale and evidence supporting an early intervention approach in schizophrenia. Methods: A selective literature review was conducted. Results: During the onset of schizophrenia, there is often a significant delay between the emergence of psychotic symptoms...

Constructing a Theory- and Evidence-Based Treatment Rationale for Complex eHealth Interventions: Development of an Online Alcohol Intervention Using an Intervention Mapping Approach.

Science.gov (United States)

Brendryen, Håvar; Johansen, Ayna; Nesvåg, Sverre; Kok, Gerjo; Duckert, Fanny

2013-01-23

Due to limited reporting of intervention rationale, little is known about what distinguishes a good intervention from a poor one. To support improved design, there is a need for comprehensive reports on novel and complex theory-based interventions. Specifically, the emerging trend of just-in-time tailoring of content in response to change in target behavior or emotional state is promising. The objective of this study was to give a systematic and comprehensive description of the treatment rationale of an online alcohol intervention called Balance. We used the intervention mapping protocol to describe the treatment rationale of Balance. The intervention targets at-risk drinking, and it is delivered by email, mobile phone text messaging, and tailored interactive webpages combining text, pictures, and prerecorded audio. The rationale of the current treatment was derived from a self-regulation perspective, and the overarching idea was to support continued self-regulation throughout the behavior change process. Maintaining the change efforts over time and coping adaptively during critical moments (eg, immediately before and after a lapse) are key factors to successful behavior change. Important elements of the treatment rationale to achieving these elements were: (1) emotion regulation as an inoculation strategy against self-regulation failure, (2) avoiding lapses by adaptive coping, and (3) avoiding relapse by resuming the change efforts after a lapse. Two distinct and complementary delivery strategies were used, including a day-to-day tunnel approach in combination with just-in-time therapy. The tunnel strategy was in accordance with the need for continuous self-regulation and it functions as a platform from which just-in-time therapy was launched. Just-in-time therapy was used to support coping during critical moments, and started when the client reports either low self-efficacy or that they were drinking above target levels. The descriptions of the treatment

Developing the Clarity and Openness in Reporting: E3-based (CORE) Reference user manual for creation of clinical study reports in the era of clinical trial transparency.

Science.gov (United States)

Hamilton, Samina; Bernstein, Aaron B; Blakey, Graham; Fagan, Vivien; Farrow, Tracy; Jordan, Debbie; Seiler, Walther; Shannon, Anna; Gertel, Art

2016-01-01

Interventional clinical studies conducted in the regulated drug research environment are reported using International Council for Harmonisation (ICH) regulatory guidance documents: ICH E3 on the structure and content of clinical study reports (CSRs) published in 1995 and ICH E3 supplementary Questions & Answers (Q & A) published in 2012.Since the ICH guidance documents were published, there has been heightened awareness of the importance of disclosure of clinical study results. The use of the CSR as a key source document to fulfil emerging obligations has resulted in a re-examination of how ICH guidelines are applied in CSR preparation. The dynamic regulatory and modern drug development environments create emerging reporting challenges. Regulatory medical writing and statistical professionals developed Clarity and Openness in Reporting: E3-based (CORE) Reference over a 2-year period. Stakeholders contributing expertise included a global industry association, regulatory agency, patient advocate, academic and Principal Investigator representatives. CORE Reference should help authors navigate relevant guidelines as they create CSR content relevant for today's studies. It offers practical suggestions for developing CSRs that will require minimum redaction and modification prior to public disclosure.CORE Reference comprises a Preface, followed by the actual resource. The Preface clarifies intended use and underlying principles that inform resource utility. The Preface lists references contributing to development of the resource, which broadly fall into 'regulatory' and 'public disclosure' categories. The resource includes ICH E3 guidance text, ICH E3 Q & A 2012-derived guidance text and CORE Reference text, distinguished from one another through the use of shading. Rationale comments are used throughout for clarification purposes.A separate mapping tool comparing ICH E3 sectional structure and CORE Reference sectional structure is also provided.Together, CORE Reference

Of Private, Common, and Public Property and the Rationale for Total Privatization

Directory of Open Access Journals (Sweden)

Hans-Hermann Hoppe

2011-02-01

Full Text Available In this paper, first, I want to clarify the nature and function of private property. Second, I want to clarify the distinction between “common” goods and property and “public” goods and property, and explain the construction error inherent in the institution of public goods and property. Third, I want to explain the rationale and principle of privatization.

Rationale, description and baseline findings of a community-based prospective cohort study of kidney function amongst the young rural population of Northwest Nicaragua.

Science.gov (United States)

González-Quiroz, Marvin; Camacho, Armando; Faber, Dorien; Aragón, Aurora; Wesseling, Catharina; Glaser, Jason; Le Blond, Jennifer; Smeeth, Liam; Nitsch, Dorothea; Pearce, Neil; Caplin, Ben

2017-01-13

An epidemic of Mesoamerican Nephropathy (MeN) is killing thousands of agricultural workers along the Pacific coast of Central America, but the natural history and aetiology of the disease remain poorly understood. We have recently commenced a community-based longitudinal study to investigate Chronic Kidney Disease (CKD) in Nicaragua. Although logistically challenging, study designs of this type have the potential to provide important insights that other study designs cannot. In this paper we discuss the rationale for conducting this study and summarize the findings of the baseline visit. The baseline visit of the community-based cohort study was conducted in 9 communities in the North Western Nicaragua in October and November 2014. All of the young men, and a random sample of young women (aged 18-30) without a pre-existing diagnosis of CKD were invited to participate. Glomerular filtration rate (eGFR) was estimated with CKD-EPI equation, along with clinical measurements, questionnaires, biological and environmental samples to evaluate participants' exposures to proposed risk factors for MeN. We identified 520 young adults (286 males and 234 females) in the 9 different communities. Of these, 16 males with self-reported CKD and 5 females with diagnoses of either diabetes or hypertension were excluded from the study population. All remaining 270 men and 90 women, selected at random, were then invited to participate in the study; 350 (97%) agreed to participate. At baseline, 29 (11%) men and 1 (1%) woman had an eGFR <90 mL/min/1.73 m 2 . Conducting a community based study of this type requires active the involvement of communities and commitment from local leaders. Furthermore, a research team with strong links to the area and broad understanding of the context of the problem being studied is essential. The key findings will arise from follow-up, but it is striking that 5% of males under aged 30 had to be excluded because of pre-existing kidney disease, and that

Conceptual design studies for the European DEMO divertor: Rationale and first results

International Nuclear Information System (INIS)

You, J.H.; Mazzone, G.; Visca, E.; Bachmann, Ch.; Autissier, E.; Barrett, T.; Cocilovo, V.; Crescenzi, F.; Domalapally, P.K.; Dongiovanni, D.; Entler, S.; Federici, G.; Frosi, P.; Fursdon, M.; Greuner, H.; Hancock, D.; Marzullo, D.; McIntosh, S.; Müller, A.V.; Porfiri, M.T.

2016-01-01

Highlights: • A brief overview is given on the overall R&D activities of the work package Divertor which is a project of the EUROfusion Consortium. • The rationale of the hydraulic, thermal and structural design scheme is described. • The first results obtained for the preliminary DEMO divertor cassette model are presented. - Abstract: In the European fusion roadmap, reliable power handling has been defined as one of the most critical challenges for realizing a commercially viable fusion power. In this context, the divertor is the key in-vessel component, as it is responsible for power exhaust and impurity removal for which divertor target is subjected to very high heat flux loads. To this end, an integrated R&D project was launched in the EUROfusion Consortium in order to deliver a holistic conceptual design solution together with the core technologies for the entire divertor system of a DEMO reactor. The work package ‘Divertor’ consists of two project areas: ‘Cassette design and integration’ and ‘Target development’. The essential mission of the project is to develop and verify advanced design concepts and the required technologies for a divertor system being capable of meeting the physical and system requirements defined for the next-generation European DEMO reactor. In this contribution, a brief overview is presented of the works from the first project year (2014). Focus is put on the loads specification, design boundary conditions, materials requirements, design approaches, and R&D strategy. Initial ideas and first estimates are presented.

Conceptual design studies for the European DEMO divertor: Rationale and first results

Energy Technology Data Exchange (ETDEWEB)

You, J.H., E-mail: you@ipp.mpg.de [Max Planck Institute for Plasma Physics, Boltzmann Str. 2, 85748 Garching (Germany); Mazzone, G.; Visca, E. [ENEA, Unità Tecnica Fusione, ENEA C. R. Frascati, via E. Fermi 45, 00044 Frascati (Italy); Bachmann, Ch. [EUROfusion PMU, c/o IPP, Boltzmann Str. 2, 85748 Garching (Germany); Autissier, E. [CEA, IRFM, F-13108 Saint Paul Lez Durance (France); Barrett, T. [CCFE, Culham Science Centre, Abingdon OX14 3DB (United Kingdom); Cocilovo, V.; Crescenzi, F. [ENEA, Unità Tecnica Fusione, ENEA C. R. Frascati, via E. Fermi 45, 00044 Frascati (Italy); Domalapally, P.K. [Research Cnter Rez, Hlavní 130, 250 68 Husinec–Řež (Czech Republic); Dongiovanni, D. [ENEA, Unità Tecnica Fusione, ENEA C. R. Frascati, via E. Fermi 45, 00044 Frascati (Italy); Entler, S. [Institute of Plasma Physics CAS, Za Slovankou 3, 182 00 Praha 8 (Czech Republic); Federici, G. [EUROfusion PMU, c/o IPP, Boltzmann Str. 2, 85748 Garching (Germany); Frosi, P. [ENEA, Unità Tecnica Fusione, ENEA C. R. Frascati, via E. Fermi 45, 00044 Frascati (Italy); Fursdon, M. [CCFE, Culham Science Centre, Abingdon OX14 3DB (United Kingdom); Greuner, H. [Max Planck Institute for Plasma Physics, Boltzmann Str. 2, 85748 Garching (Germany); Hancock, D. [CCFE, Culham Science Centre, Abingdon OX14 3DB (United Kingdom); Marzullo, D. [CREATE, University of Naples Federico II, P.le Tecchio 80, 80125 Napoli (Italy); McIntosh, S. [CCFE, Culham Science Centre, Abingdon OX14 3DB (United Kingdom); Müller, A.V. [Max Planck Institute for Plasma Physics, Boltzmann Str. 2, 85748 Garching (Germany); Porfiri, M.T. [ENEA, Unità Tecnica Fusione, ENEA C. R. Frascati, via E. Fermi 45, 00044 Frascati (Italy); and others

2016-11-01

Highlights: • A brief overview is given on the overall R&D activities of the work package Divertor which is a project of the EUROfusion Consortium. • The rationale of the hydraulic, thermal and structural design scheme is described. • The first results obtained for the preliminary DEMO divertor cassette model are presented. - Abstract: In the European fusion roadmap, reliable power handling has been defined as one of the most critical challenges for realizing a commercially viable fusion power. In this context, the divertor is the key in-vessel component, as it is responsible for power exhaust and impurity removal for which divertor target is subjected to very high heat flux loads. To this end, an integrated R&D project was launched in the EUROfusion Consortium in order to deliver a holistic conceptual design solution together with the core technologies for the entire divertor system of a DEMO reactor. The work package ‘Divertor’ consists of two project areas: ‘Cassette design and integration’ and ‘Target development’. The essential mission of the project is to develop and verify advanced design concepts and the required technologies for a divertor system being capable of meeting the physical and system requirements defined for the next-generation European DEMO reactor. In this contribution, a brief overview is presented of the works from the first project year (2014). Focus is put on the loads specification, design boundary conditions, materials requirements, design approaches, and R&D strategy. Initial ideas and first estimates are presented.

Mediterranean studies of cardiovascular disease and hyperglycemia: analytical modeling of population socio-economic transitions (MedCHAMPS)--rationale and methods.

Science.gov (United States)

Maziak, Wasim; Critchley, Julia; Zaman, Shahaduz; Unwin, Nigel; Capewell, Simon; Bennett, Kathleen; Unal, Belgin; Husseini, Abdullatif; Romdhane, Habiba Ben; Phillimore, Peter

2013-08-01

In response to the escalating epidemic of cardiovascular disease (CVD) in the Mediterranean Region (MR), an international collaboration aiming at understanding the burden of CVD and evaluating cost-effective strategies to combat it was recently established. This paper describes the rationale and methods of the project MedCHAMPS to disseminate this successful experience. The framework of MedCHAMPS is exceptional in combining multiple disciplines (e.g. epidemiology, anthropology, economics), countries [Turkey, Syria, occupied Palestinian territory (oPt), Tunisia, UK, Ireland], research methods (situational and policy analysis, quantitative and qualitative studies, statistical modeling), and involving local stakeholders at all levels to assess trends of CVD/diabetes in the society and attributes of the local health care systems to provide optimal policy recommendations to reduce the burden of CVD/diabetes. MedCHAMPS provides policy makers in the MR and beyond needed guidance about the burden of CVD, and best cost-effective ways to combat it. Our approach of building developed-developing countries collaboration also provides a roadmap for other researchers seeking to build research base into CVD epidemiology and prevention in developing countries.

Physiology, regulation and multifunctional activity of the gut wall: a rationale for multicompartmental modelling

NARCIS (Netherlands)

Bannink, A.; Dijkstra, J.; Koopmans, S.J.; Mroz, Z.

2006-01-01

A rationale is given for a modelling approach to identify the mechanisms involved in the functioning and metabolic activity of tissues in the wall of the gastrointestinal tract. Maintenance and productive functions are discussed and related to the distinct compartments of the gastrointestinal tract

Risk assessment instruments in clinical practice.

Science.gov (United States)

Côté, Gilles; Crocker, Anne G; Nicholls, Tonia L; Seto, Michael C

2012-04-01

To determine whether the items in one of the most widely validated instruments of violence risk assessment, the Historical-Clinical-Risk Management-20 (HCR-20), are used in review board hearings to assess the risk of violence by people found Not Criminally Responsible on account of Mental Disorder (NCRMD). This study was conducted from October 2004 to August 2006 in Quebec's sole forensic psychiatric hospital and 2 large civil psychiatric hospitals designated for the care of people declared NCRMD in the Montreal metropolitan area. The risk assessments presented by clinicians at annual review board hearings and the boards' rationale for the release or detention of people found NCRMD were contrasted with the risk assessments conducted by the research team using the HCR-20. The final sample was comprised of 96 men. Very few of the risk factors identified by prior research (HCR-20 items) were mentioned in the hearing process, whether in clinical reports, discussions during the hearing, or in the disposition justification. The findings confirm that there remains a significant gap between research evidence and risk assessment practice.

TH-A-18A-01: Innovation in Clinical Breast Imaging

International Nuclear Information System (INIS)

Liu, B; Yang, K; Yaffe, M; Chen, J

2014-01-01

Several novel modalities have been or are on the verge of being introduced into the breast imaging clinic. These include tomosynthesis imaging, dedicated breast CT, contrast-enhanced digital mammography, and automated breast ultrasound, all of which are covered in this course. Tomosynthesis and dedicated breast CT address the problem of tissue superimposition that limits mammography screening performance, by improved or full resolution of the 3D breast morphology. Contrast-enhanced digital mammography provides functional information that allows for visualization of tumor angiogenesis. 3D breast ultrasound has high sensitivity for tumor detection in dense breasts, but the imaging exam was traditionally performed by radiologists. In automated breast ultrasound, the scan is performed in an automated fashion, making for a more practical imaging tool, that is now used as an adjunct to digital mammography in breast cancer screening. This course will provide medical physicists with an in-depth understanding of the imaging physics of each of these four novel imaging techniques, as well as the rationale and implementation of QC procedures. Further, basic clinical applications and work flow issues will be discussed. Learning Objectives: To be able to describe the underlying physical and physiological principles of each imaging technique, and to understand the corresponding imaging acquisition process. To be able to describe the critical system components and their performance requirements. To understand the rationale and implementation of quality control procedures, as well as regulatory requirements for systems with FDA approval. To learn about clinical applications and understand risks and benefits/strength and weakness of each modality in terms of clinical breast imaging

The Effect of Topical Amphotericin B on Inflammatory Markers in Patients With Chronic Rhinosinusitis: A Multicenter Randomized Controlled Study

NARCIS (Netherlands)

Ebbens, Fenna A.; Georgalas, Christos; Luiten, Silvia; van Drunen, Cornelis M.; Badia, Lydia; Scadding, Glenis K.; Hellings, Peter W.; Jorissen, Mark; Mullol, Joaquim; Cardesin, Alda; Bachert, Claus; van Zele, Thibaut P. J.; Lund, Valerie J.; Fokkens, W. J.

2009-01-01

Background: It has been suggested that an exaggerated immune response to fungi is crucial in the pathogenesis of chronic rhinosinusitis (CRS). Based on this rationale, the use of topical antifungals (amphotericin B) has been advocated. Studies on its clinical effectiveness are, however,

Educational Rationale Metadata for Learning Objects

Directory of Open Access Journals (Sweden)

Tom Carey

2002-10-01

Full Text Available Instructors searching for learning objects in online repositories will be guided in their choices by the content of the object, the characteristics of the learners addressed, and the learning process embodied in the object. We report here on a feasibility study for metadata to record process-oriented information about instructional approaches for learning objects, though a set of Educational Rationale [ER] tags which would allow authors to describe the critical elements in their design intent. The prototype ER tags describe activities which have been demonstrated to be of value in learning, and authors select the activities whose support was critical in their design decisions. The prototype ER tag set consists descriptors of the instructional approach used in the design, plus optional sub-elements for Comments, Importance and Features which implement the design intent. The tag set was tested by creators of four learning object modules, three intended for post-secondary learners and one for K-12 students and their families. In each case the creators reported that the ER tag set allowed them to express succinctly the key instructional approaches embedded in their designs. These results confirmed the overall feasibility of the ER tag approach as a means of capturing design intent from creators of learning objects. Much work remains to be done before a usable ER tag set could be specified, including evaluating the impact of ER tags during design to improve instructional quality of learning objects.

The declining demand for hospital care as a rationale for duty hour reform.

Science.gov (United States)

Jena, Anupam B; DePasse, Jacqueline W; Prasad, Vinay

2014-10-01

The regulation of duty hours of physicians in training remains among the most hotly debated subjects in medical education. Although recent duty hour reforms have been chiefly motivated by concerns about resident well-being and medical errors attributable to resident fatigue, the debate surrounding duty hour reform has infrequently involved discussion of one of the most important secular changes in hospital care that has affected nearly all developed countries over the last 3 decades: the declining demand for hospital care. For example, in 1980, we show that resident physicians in US teaching hospitals provided, on average, 1,302 inpatient days of care per resident physician compared to 593 inpatient days in 2011, a decline of 54%. This decline in the demand for hospital care by residents provides an under-recognized economic rationale for reducing residency duty hours, a rationale based solely on supply and demand considerations. Work hour reductions and growing requirements for outpatient training can be seen as an appropriate response to the shrinking demand for hospital care across the health-care sector.

Expanding clinical research capacity through a community of practice (CoPER).

Science.gov (United States)

Short, Alison; Jackson, Wanda; Nugus, Peter

2010-01-01

The proposed CoPER project (Community of Practice for Engaging in Research) responds to a need for increased research capacity in a clinical setting. We put forward an argument and a design for a prospective action research project to extend research capacity via an integrated academic and practitioner community of practice in an Emergency Department (ED). This paper explores the research needs of clinicians, articulates the concept of community of practice in light of these needs, and outlines the rationale for considering communities of practice as a potential contributor to building research capacity in a clinical setting. A potential methodology is suggested to test the linkage between research needs, the concept of a community of practice model in a clinical setting, and the contribution of such a model to building research capacity in a clinical setting via the CoPER framework. Combined data from this proposed mixed method action research (survey, focus groups, interviews, observation) are expected to enable the production of a set of facilitators and enablers with a view to building a community of research practice which make the case study transferable to other clinical and non-clinical work settings.

Prospective Clinical Testing of Regulatory Dendritic Cells in Organ Transplantation

OpenAIRE

Thomson, Angus W.; Zahorchak, Alan F.; Ezzelarab, Mohamed B.; Butterfield, Lisa H.; Lakkis, Fadi G.; Metes, Diana M.

2016-01-01

Dendritic cells (DC) are rare, professional antigen-presenting cells with ability to induce or regulate alloimmune responses. Regulatory DC (DCreg) with potential to down-modulate acute and chronic inflammatory conditions that occur in organ transplantation can be generated in vitro under a variety of conditions. Here, we provide a rationale for evaluation of DCreg therapy in clinical organ transplantation with the goal of promoting sustained, donor-specific hyporesponsiveness, while lowering...

Ethical aspect of the clinical research. Informed consent in the clinical research for heavy ion radiotherapy of cancer

International Nuclear Information System (INIS)

Murata, Hajime

2003-01-01

The research center for heavy ion therapy of cancer was decided to be built in 1984 as a part of the national 10-year anticancer campaign, and construction of Heavy Ion Medical Accelerator in Chiba (HIMAC) was completed at the National Institute of Radiological Sciences in 1993. The HIMAC is the first heavy ion accelerator for only medical use in the world, and the clinical research of cancer radiotherapy was begun in 1994 using carbon ion generated by HIMAC. The purposes of the clinical research are to evaluate the safety and usefulness of carbon ion for cancer treatment, and to establish carbon ion therapy as a new and valuable tool for cancer therapy. Therefore, to obtain exact data in ethical aspect as well as scientific aspect of the clinical research, many special committees have been organized like as the committees of protocol planning for each organ, clinical study groups for each organ, evaluating committee of clinical data, and the ethical committee. Each clinical research is performed according to the research protocol of each organ, in which study purpose, rationale, patient condition, end-point of the study, adverse reaction are described. The document of informed consent (IC) contains study purpose, patient condition, method, predicted effect and demerit, protection of privacy, etc.. IC to each patient is done precisely by the doctor, and the freely-given IC of the patient is obtained. After the IC was completed, judgement of propriety for carbon ion therapy is done by the ethical committee for IC of each patient. Since 1994 carbon ion therapy has been performed over 1300 patients with cancer in various organs, and its safety and usefulness for cancer treatment has been clarified gradually. The carbon ion therapy is thought to be a new and promising tool for cancer treatment near future. (authors)

Regulatory dendritic cells for promotion of liver transplant operational tolerance: Rationale for a clinical trial and accompanying mechanistic studies.

Science.gov (United States)

Thomson, Angus W; Humar, Abhinav; Lakkis, Fadi G; Metes, Diana M

2018-05-01

Dendritic cells (DC) are rare, bone marrow (BM)-derived innate immune cells that critically maintain self-tolerance in the healthy steady-state. Regulatory DC (DCreg) with capacity to suppress allograft rejection and promote transplant tolerance in pre-clinical models can readily be generated from BM precursors or circulating blood monocytes. These DCreg enhance allograft survival via various mechanisms, including promotion of regulatory T cells. In non-human primates receiving minimal immunosuppressive drug therapy (IS), infusion of DCreg of donor origin, one week before transplant, safely prolongs renal allograft survival and selectively attenuates anti-donor CD8 + memory T cell responses in the early post-transplant period. Based on these observations, and in view of the critical need to reduce patient dependence on non-specific IS agents that predispose to cardiometabolic side effects and renal insufficiency, we will conduct a first-in-human safety and preliminary efficacy study of donor-derived DCreg infusion to achieve early (18 months post-transplant) complete IS withdrawal in low-risk, living donor liver transplant recipients receiving standard-of-care IS (mycophenolate mofetil, tacrolimus and steroids). We will test the hypothesis that, although donor-derived DCreg are short-lived, they will induce robust donor-specific T cell hyporesponsiveness. We will examine immunological mechanisms by sequential analysis of blood and tissue samples, incorporating cutting-edge technologies. Copyright © 2017 American Society for Histocompatibility and Immunogenetics. Published by Elsevier Inc. All rights reserved.

Ultra Low-Dose Naloxone and Tramadol/Acetaminophen in Elderly Patients Undergoing Joint Replacement Surgery: A Pilot Study

Directory of Open Access Journals (Sweden)

Ngozi N Imasogie

2009-01-01

Full Text Available OBJECTIVE: A pilot study was conducted to assess whether both the rationale and feasibility exist for future randomized clinical trials to evaluate the combined use of naloxone infusion and tramadol/acetaminophen as opioid-sparing drugs in elderly patients undergoing lower extremity joint replacement surgery.

Should We View Chronic Obstructive Pulmonary Disease Differently after ECLIPSE? A Clinical Perspective from the Study Team

DEFF Research Database (Denmark)

Vestbo, J.; Agusti, A.; Wouters, E. F. M.

2014-01-01

. Risk factors for 3-year change in both FEV1 and lung density were assessed. For FEV1 decline, continued smoking and presence of emphysema were the strongest predictors of progression; dub cell protein was found to be a potential biomarker for disease activity. For progression of emphysema......, the strongest predictors were continued smoking and female sex. Conclusions: By following a large, well characterized cohort of patients with COPD over 3 years, we have a clearer picture of a heterogeneous disease with clinically important subtypes ("phenotypes") and a variable and not inherently progressive......Rationale: Chronic obstructive pulmonary disease (COPD) seems to be a heterogeneous disease with a variable course. Objectives: We wished to characterize the heterogeneity and variability of COPD longitudinally. Methods: In the Evaluation of COPD Longitudinally to Identify Predictive Surrogate...

How Computer Technology Expands Educational Options: A Rationale, Recommendations, and a Pamphlet for Administrators.

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Kelch, Panette Evers; Karr-Kidwell, PJ

The purpose of this paper is to provide a historical rationale on how computer technology, particularly the Internet, expands educational options for administrators and teachers. A review of the literature includes a brief history of computer technology and its growing use, and a discussion of computer technology for distance learning, for…

The Nutrition and Enjoyable Activity for Teen Girls (NEAT girls randomized controlled trial for adolescent girls from disadvantaged secondary schools: rationale, study protocol, and baseline results

Directory of Open Access Journals (Sweden)

Okely Anthony D

2010-10-01

Full Text Available Abstract Background Child and adolescent obesity predisposes individuals to an increased risk of morbidity and mortality from a range of lifestyle diseases. Although there is some evidence to suggest that rates of pediatric obesity have leveled off in recent years, this has not been the case among youth from low socioeconomic backgrounds. The purpose of this paper is to report the rationale, study design and baseline findings of a school-based obesity prevention program for low-active adolescent girls from disadvantaged secondary schools. Methods/Design The Nutrition and Enjoyable Activity for Teen Girls (NEAT Girls intervention will be evaluated using a group randomized controlled trial. NEAT Girls is a 12-month multi-component school-based intervention developed in reference to Social Cognitive Theory and includes enhanced school sport sessions, interactive seminars, nutrition workshops, lunch-time physical activity (PA sessions, PA and nutrition handbooks, parent newsletters, pedometers for self-monitoring and text messaging for social support. The following variables were assessed at baseline and will be completed again at 12- and 24-months: adiposity, objectively measured PA, muscular fitness, time spent in sedentary behaviors, dietary intake, PA and nutrition social-cognitive mediators, physical self-perception and global self-esteem. Statistical analyses will follow intention-to-treat principles and hypothesized mediators of PA and nutrition behavior change will be explored. Discussion NEAT Girls is an innovative intervention targeting low-active girls using evidence-based behavior change strategies and nutrition and PA messages and has the potential to prevent unhealthy weight gain and reduce the decline in physical activity and poor dietary habits associated with low socio-economic status. Few studies have reported the long-term effects of school-based obesity prevention programs and the current study has the potential to make an

The Nutrition and Enjoyable Activity for Teen Girls (NEAT girls) randomized controlled trial for adolescent girls from disadvantaged secondary schools: rationale, study protocol, and baseline results.

Science.gov (United States)

Lubans, David R; Morgan, Philip J; Dewar, Deborah; Collins, Clare E; Plotnikoff, Ronald C; Okely, Anthony D; Batterham, Marijka J; Finn, Tara; Callister, Robin

2010-10-28

Child and adolescent obesity predisposes individuals to an increased risk of morbidity and mortality from a range of lifestyle diseases. Although there is some evidence to suggest that rates of pediatric obesity have leveled off in recent years, this has not been the case among youth from low socioeconomic backgrounds. The purpose of this paper is to report the rationale, study design and baseline findings of a school-based obesity prevention program for low-active adolescent girls from disadvantaged secondary schools. The Nutrition and Enjoyable Activity for Teen Girls (NEAT Girls) intervention will be evaluated using a group randomized controlled trial. NEAT Girls is a 12-month multi-component school-based intervention developed in reference to Social Cognitive Theory and includes enhanced school sport sessions, interactive seminars, nutrition workshops, lunch-time physical activity (PA) sessions, PA and nutrition handbooks, parent newsletters, pedometers for self-monitoring and text messaging for social support. The following variables were assessed at baseline and will be completed again at 12- and 24-months: adiposity, objectively measured PA, muscular fitness, time spent in sedentary behaviors, dietary intake, PA and nutrition social-cognitive mediators, physical self-perception and global self-esteem. Statistical analyses will follow intention-to-treat principles and hypothesized mediators of PA and nutrition behavior change will be explored. NEAT Girls is an innovative intervention targeting low-active girls using evidence-based behavior change strategies and nutrition and PA messages and has the potential to prevent unhealthy weight gain and reduce the decline in physical activity and poor dietary habits associated with low socio-economic status. Few studies have reported the long-term effects of school-based obesity prevention programs and the current study has the potential to make an important contribution to the field. Australian New Zealand Clinical

A preliminary report of music-based training for adult cochlear implant users: rationales and development

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Gfeller, Kate; Guthe, Emily; Driscoll, Virginia; Brown, Carolyn J.

2015-01-01

Objective This paper provides a preliminary report of a music-based training program for adult cochlear implant (CI) recipients. Included in this report are descriptions of the rationale for music-based training, factors influencing program development, and the resulting program components. Methods Prior studies describing experience-based plasticity in response to music training, auditory training for persons with hearing impairment, and music training for cochlear implant recipients were reviewed. These sources revealed rationales for using music to enhance speech, factors associated with successful auditory training, relevant aspects of electric hearing and music perception, and extant evidence regarding limitations and advantages associated with parameters for music training with CI users. This information formed the development of a computer-based music training program designed specifically for adult CI users. Results Principles and parameters for perceptual training of music, such as stimulus choice, rehabilitation approach, and motivational concerns were developed in relation to the unique auditory characteristics of adults with electric hearing. An outline of the resulting program components and the outcome measures for evaluating program effectiveness are presented. Conclusions Music training can enhance the perceptual accuracy of music, but is also hypothesized to enhance several features of speech with similar processing requirements as music (e.g., pitch and timbre). However, additional evaluation of specific training parameters and the impact of music-based training on speech perception of CI users are required. PMID:26561884

The Impact of a Course on Nature of Science Pedagogical Views and Rationales: Comparing Preservice Teachers in Their First versus Second Experience

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Kruse, Jerrid W.; Easter, Jaclyn M.; Edgerly, Hallie S.; Seebach, Colin; Patel, Neal

2017-01-01

This study explored changes in preservice teachers' (PSTs) nature of science pedagogical (NOSP) views and nature of science (NOS) rationales using pre- and post-course written responses as well as interview data. Through systematic analysis, themes were generated and compared to the NOS literature. Comparisons between pre- and post-course data…

Prospective clinical testing of regulatory dendritic cells (DCreg) in organ transplantation

OpenAIRE

ANGUS W THOMSON; ALAN F ZAHORCHAK; Mohamed B. Ezzelarab; Lisa H. Butterfield; Fadi G. Lakkis; Diana M Metes

2016-01-01

Dendritic cells (DC) are rare, professional antigen-presenting cells with ability to induce or regulate alloimmune responses. Regulatory DC (DCreg) with potential to down-modulate acute and chronic inflammatory conditions that occur in organ transplantation can be generated in vitro under a variety of conditions. Here, we provide a rationale for evaluation of DCreg therapy in clinical organ transplantation with the goal of promoting sustained, donor-specific hyporesponsiveness, while lowering...

A randomized controlled trial investigation of a non-stimulant in attention deficit hyperactivity disorder (ACTION: Rationale and design

Directory of Open Access Journals (Sweden)

Clarke Simon D

2011-03-01

Full Text Available Abstract Background The ACTION study (Attention deficit hyperactivity disorder Controlled Trial Investigation Of a Non-stimulant is a multi-center, double-blind, randomized cross-over trial of the non-stimulant medication, Atomoxetine, in children and adolescents with attention deficit hyperactivity disorder (ADHD. The primary aims are to examine the efficacy of atomoxetine for improving cognition and emotional function in ADHD and whether any improvements in these outcomes are more pronounced in participants with comorbid anxiety; and to determine if changes in these outcomes after atomoxetine are more reliable than changes in diagnostic symptoms of ADHD. This manuscript will describe the methodology and rationale for the ACTION study. Methods Children and adolescents aged 6 - 17 y with ADHD will be enrolled. Clinical interview and validated scales will be used to confirm diagnosis and screen for exclusion criteria, which include concurrent stimulant use, and comorbid psychiatric or neurological conditions other than anxiety. Three assessment sessions will be conducted over the 13-week study period: Session 1 (Baseline, pre-treatment, Session 2 (six weeks, atomoxetine or placebo, and Session 3 (13 weeks, cross-over after one-week washout period. The standardized touch-screen battery, "IntegNeuro™", will be used to assess cognitive and emotional function. The primary measure of response will be symptom ratings, while quality of life will be a secondary outcome. Logistic regression will be used to determine predictors of treatment response, while repeated measures of analysis will determine any differences in effect of atomoxetine and placebo. Results The methodology for the ACTION study has been detailed. Conclusions The ACTION study is the first controlled trial to investigate the efficacy of atomoxetine using objective cognitive and emotional function markers, and whether these objective measures predict outcomes with atomoxetine in ADHD

The Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome (TRA*CER) trial: study design and rationale.

Science.gov (United States)

2009-09-01

The protease-activated receptor 1 (PAR-1), the main platelet receptor for thrombin, represents a novel target for treatment of arterial thrombosis, and SCH 530348 is an orally active, selective, competitive PAR-1 antagonist. We designed TRA*CER to evaluate the efficacy and safety of SCH 530348 compared with placebo in addition to standard of care in patients with non-ST-segment elevation (NSTE) acute coronary syndromes (ACS) and high-risk features. TRA*CER is a prospective, randomized, double-blind, multicenter, phase III trial with an original estimated sample size of 10,000 subjects. Our primary objective is to demonstrate that SCH 530348 in addition to standard of care will reduce the incidence of the composite of cardiovascular death, myocardial infarction (MI), stroke, recurrent ischemia with rehospitalization, and urgent coronary revascularization compared with standard of care alone. Our key secondary objective is to determine whether SCH 530348 will reduce the composite of cardiovascular death, MI, or stroke compared with standard of care alone. Secondary objectives related to safety are the composite of moderate and severe GUSTO bleeding and clinically significant TIMI bleeding. The trial will continue until a predetermined minimum number of centrally adjudicated primary and key secondary end point events have occurred and all subjects have participated in the study for at least 1 year. The TRA*CER trial is part of the large phase III SCH 530348 development program that includes a concomitant evaluation in secondary prevention. TRA*CER will define efficacy and safety of the novel platelet PAR-1 inhibitor SCH 530348 in the treatment of high-risk patients with NSTE ACS in the setting of current treatment strategies.

Rationale for and protocol of a multi-national population-based bacteremia surveillance collaborative

Directory of Open Access Journals (Sweden)

Church Deirdre L

2009-07-01

Full Text Available Abstract Background Bloodstream infections are frequent causes of human illness and cause major morbidity and death. In order to best define the epidemiology of these infections and to track changes in occurrence, adverse outcome, and resistance rates over time, population based methodologies are optimal. However, few population-based surveillance systems exist worldwide, and because of differences in methodology inter-regional comparisons are limited. In this report we describe the rationale and propose first practical steps for developing an international collaborative approach to the epidemiologic study and surveillance for bacteremia. Findings The founding collaborative participants represent six regions in four countries in three continents with a combined annual surveillance population of more than 8 million residents. Conclusion Future studies from this collaborative should lead to a better understanding of the epidemiology of bloodstream infections.

Prolactinomas : clinical studies

NARCIS (Netherlands)

Kars, Marleen

2008-01-01

Prolactinoma are treated with dopamine agonists, which are effective in reducing prolactin and tumor size. Studies reporting clinical and radiological outcome are scarce. The study described in chapter 2, assesses long-term outcome in patients treated with dopamine agonists for macroprolactinoma. An

Rationale and methods of the European Study on Cardiovascular Risk Prevention and Management in Daily Practice (EURIKA

Directory of Open Access Journals (Sweden)

Jiménez Francisco

2010-06-01

Full Text Available Abstract Background The EURIKA study aims to assess the status of primary prevention of cardiovascular disease (CVD across Europe. Specifically, it will determine the degree of control of cardiovascular risk factors in current clinical practice in relation to the European guidelines on cardiovascular prevention. It will also assess physicians' knowledge and attitudes about CVD prevention as well as the barriers impeding effective risk factor management in clinical practice. Methods/Design Cross-sectional study conducted simultaneously in 12 countries across Europe. The study has two components: firstly at the physician level, assessing eight hundred and nine primary care and specialist physicians with a daily practice in CVD prevention. A physician specific questionnaire captures information regarding physician demographics, practice settings, cardiovascular prevention beliefs and management. Secondly at the patient level, including 7641 patients aged 50 years or older, free of clinical CVD and with at least one classical risk factor, enrolled by the participating physicians. A patient-specific questionnaire captures information from clinical records and patient interview regarding sociodemographic data, CVD risk factors, and current medications. Finally, each patient provides a fasting blood sample, which is sent to a central laboratory for measuring serum lipids, apolipoproteins, hemoglobin-A1c, and inflammatory biomarkers. Discussion Primary prevention of CVD is an extremely important clinical issue, with preventable circulatory diseases remaining the leading cause of major disease burden. The EURIKA study will provide key information to assess effectiveness of and attitudes toward primary prevention of CVD in Europe. A transnational study creates opportunities for benchmarking good clinical practice across countries and improving outcomes. (ClinicalTrials.gov number, NCT00882336.

Unhealthy smokers: scopes for prophylactic intervention and clinical treatment.

Science.gov (United States)

Prasad, Shikha; Kaisar, Mohammad Abul; Cucullo, Luca

2017-10-04

Globally, tobacco use causes approximately 6 million deaths per year, and predictions report that with current trends; more than 8 million deaths are expected annually by 2030. Cigarette smokings is currently accountable for more than 480,000 deaths each year in United States (US) and is the leading cause of preventable death in the US. On average, smokers die 10 years earlier than nonsmokers and if smoking continues at its current proportion among adolescents, one in every 13 Americans aged 17 years or younger is expected to die prematurely from a smoking-related illness. Even though there has been a marginal smoking decline of around 5% in recent years (2005 vs 2015), smokers still account for 15% of the US adult population. What is also concerning is that 41,000 out of 480,000 deaths results from secondhand smoke (SHS) exposure. Herein, we provide a detailed review of health complications and major pathological mechanisms including mutation, inflammation, oxidative stress, and hemodynamic and plasma protein changes associated with chronic smoking. Further, we discuss prophylactic interventions and associated benefits and provide a rationale for the scope of clinical treatment. Considering these premises, it is evident that much detailed translational and clinical studies are needed. Factors such as the length of smoking cessation for ex-smokers, the level of smoke exposure in case of SHS, pre-established health conditions, genetics (and epigenetics modification caused by chronic smoking) are few of the criteria that need to be evaluated to begin assessing the prophylactic and/or therapeutic impact of treatments aimed at chronic and former smokers (especially early stage ex-smokers) including those frequently subjected to second hand tobacco smoke exposure. Herein, we provide a detailed review of health complications and major pathological mechanisms including mutation, inflammation, oxidative stress, and hemodynamic and plasma protein changes associated with

Integrating the Beliefs of Dewey, Lewin, and Rogers into a Rationale for Effective Group Leadership.

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Grove, Richard W.

1992-01-01

Presents a rationale for effective group leadership grounded in John Withall's articulation of selected beliefs of John Dewey, Kurt Lewin, and Carl Rogers. Teachers and administrators need more and better preparation in collaborative inquiry. Knowledge and skills in collaborative inquiry should undergird the successful functioning of groups of…

Developing Federal Clinical Care Recommendations for Women.

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Godfrey, Emily M; Tepper, Naomi K; Curtis, Kathryn M; Moskosky, Susan B; Gavin, Loretta E

2015-08-01

The provision of family planning services has important health benefits for the U.S. Approximately 25 million women in the U.S. receive contraceptive services annually and 44 million make at least one family planning-related clinical visit each year. These services are provided by private clinicians, as well as publicly funded clinics, including specialty family planning clinics, health departments, Planned Parenthoods, community health centers, and primary care clinics. Recommendations for providing quality family planning services have been published by CDC and the Office of Population Affairs of the DHHS. This paper describes the process used to develop the women's clinical services portion of the new recommendations and the rationale underpinning them. The recommendations define family planning services as contraceptive care, pregnancy testing and counseling, achieving pregnancy, basic infertility care, sexually transmitted disease services, and preconception health. Because many women who seek family planning services have no other source of care, the recommendations also include additional screening services related to women's health, such as cervical cancer screening. These clinical guidelines are aimed at providing the highest-quality care and are designed to establish a national standard for family planning in the U.S. Published by Elsevier Inc.

A doctor in the house: rationale for providing on-site urological consultation to geriatric patients in nursing health care facilities.

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Watson, Richard A; Suchak, Nihirika; Steel, Knight

2010-08-01

To establish a rationale for providing on-site urological care on a regular basis in the nursing health care center setting and to share "lessons learned," which we have garnered in providing that care over a 5-year experience. We have reviewed and assessed our experiences in providing urological outreach to nursing health care center patients. Our outreach program has been well received both by patients and by health care center personnel. Over this time, we have capitalized on many advantages that this initiative offers, and we have gained, through this experience, several "lessons learned," not only regarding what to do, but also what to avoid. Advantages to on-site urological care include: (1) timely, targeted clinical intervention; (2) significant disease prevention; (3) expedition of treatment; (4) health care provider education; and (5) rich opportunities for clinical investigation. In addition, the on-site urologist can provide the health care center with helpful advice and validation in meeting federal and state health care requirements. Unfortunately, to date, remuneration for such programs has been discouraging. Federal and state regulations continue to impede innovative change. Copyright (c) 2010 Elsevier Inc. All rights reserved.

Can lifestyle modification improve neurocognition? Rationale and design of the ENLIGHTEN clinical trial.

Science.gov (United States)

Blumenthal, James A; Smith, Patrick J; Welsh-Bohmer, Kathleen; Babyak, Michael A; Browndyke, Jeffrey; Lin, Pao-Hwa; Doraiswamy, P Murali; Burke, James; Kraus, William; Hinderliter, Alan; Sherwood, Andrew

2013-01-01

Risk factors for cardiovascular disease (CVD) not only increase the risk for clinical CVD events, but also are associated with a cascade of neurophysiologic and neuroanatomic changes that increase the risk of cognitive impairment and dementia. Although epidemiological studies have shown that exercise and diet are associated with lower CVD risk and reduced incidence of dementia, no randomized controlled trial (RCT) has examined the independent effects of exercise and diet on neurocognitive function among individuals at risk for dementia. The ENLIGHTEN trial is a RCT of patients with CVD risk factors who also are characterized by subjective cognitive complaints and objective evidence of neurocognitive impairment without dementia (CIND) STUDY DESIGN: A 2 by 2 design will examine the independent and combined effects of diet and exercise on neurocognition. 160 participants diagnosed with CIND will be randomly assigned to 6 months of aerobic exercise, the DASH diet, or a combination of both exercise and diet; a (control) group will receive health education but otherwise will maintain their usual dietary and activity habits. Participants will complete comprehensive assessments of neurocognitive functioning along with biomarkers of CVD risk including measures of blood pressure, glucose, endothelial function, and arterial stiffness. The ENLIGHTEN trial will (a) evaluate the effectiveness of aerobic exercise and the DASH diet in improving neurocognitive functioning in CIND patients with CVD risk factors; (b) examine possible mechanisms by which exercise and diet improve neurocognition; and (c) consider potential moderators of treatment, including subclinical CVD. Copyright © 2012 Elsevier Inc. All rights reserved.

Driving clinical study efficiency by using a productivity breakdown model: comparative evaluation of a global clinical study and a similar Japanese study.

Science.gov (United States)

Takahashi, K; Sengoku, S; Kimura, H

2011-02-01

A fundamental management imperative of pharmaceutical companies is to contain surging costs of developing and launching drugs globally. Clinical studies are a research and development (R&D) cost driver. The objective of this study was to develop a productivity breakdown model, or a key performance indicator (KPI) tree, for an entire clinical study and to use it to compare a global clinical study with a similar Japanese study. We, thereby, hope to identify means of improving study productivity. We developed the new clinical study productivity breakdown model, covering operational aspects and cost factors. Elements for improving clinical study productivity were assessed from a management viewpoint by comparing empirical tracking data from a global clinical study with a Japanese study with similar protocols. The following unique and material differences, beyond simple international difference in cost of living, that could affect the efficiency of future clinical trials were identified: (i) more frequent site visits in the Japanese study, (ii) head counts at the Japanese study sites more than double those of the global study and (iii) a shorter enrollment time window of about a third that of the global study at the Japanese study sites. We identified major differences in the performance of the two studies. These findings demonstrate the potential of the KPI tree for improving clinical study productivity. Trade-offs, such as those between reduction in head count at study sites and expansion of the enrollment time window, must be considered carefully. © 2010 Blackwell Publishing Ltd.

A 13-year cohort study of musculoskeletal disorders treated in an autoplant, on-site physiotherapy clinic.

Science.gov (United States)

Sadi, Jackie; MacDermid, Joy C; Chesworth, Bert; Birmingham, Trevor

2007-12-01

The purpose of this study was to describe the rate and distribution of treatment visits provided in an on-site, automotive plant, physiotherapy clinic over a 13-year period. A retrospective cohort study was conducted using data collected at an on-site physiotherapy clinic (1990-2002, 65,977 visits; n = 2,636 workers). The average age of workers was 43 +/- 9 years; most remained at work (85%) when treated. Disorders most commonly affected the shoulder, lumbar, and cervical regions; the median number of visits for these was 7, 6, and 5, respectively. Elbow disorders occurred commonly only for work-related complaints and required a median of eight visits. Rate of utilization was higher for women, with 47% of the plant's female workers attending physiotherapy in 1 year. Women had higher rates of cervical spine (12 vs. 22%) and wrist (5 vs. 10%) disorders. The two most common causes of injury reported by workers with an industrial injury were "frank injury arising out of normal employment" (51%) and "gradual onset/no frank injury" (37%). The diagnosis most often reported by the physiotherapist after initial assessment was "strain" which was similar for both industrial (43%) and non-industrial (49%) injuries. The six main departments in this automotive plant account for 93% of all industrial injuries reported. Final Assembly accounted for the largest number and highest rate of injury, although shift variability was noted in utilization rates (13 vs. 26%), despite the same tasks, shift schedules, and demographics. Although there was no control group, the number of visits to discharge was lower than reported in the literature for off-site physical therapy; there was a large reduction in claims (441-275) following introduction of the clinic and reduced duration/costs of lost time were identified by the employer as a rationale to continue and enhance the service over time. On-site physiotherapy services can provide early, cost-effective management of WRMSD in the automotive

The role of psychophysiology in clinical assessment: ERPs in the evaluation of memory.

Science.gov (United States)

Allen, John J B

2002-05-01

Psychophysiological measures hold great potential for informing clinical assessments. The challenge, before such measures can be widely used, is to develop test procedures and analysis strategies that allow for statistically reliable and valid decisions to be made for any particular examinee, despite large individual differences in psychophysiological responding. Focusing on the evaluation of memory in clinical, criminal, and experimental contexts, this paper reviews the rationale for and development of ERP-based memory assessment procedures, with a focus on methods that allow for statistically supported decisions to be made in the case of a single examinee. The application of one such procedure to the study of amnesia in Dissociative Identity Disorder is highlighted. To facilitate the development of other psychophysiological assessment tools, psychophysiological researchers are encouraged to report the sensitivity and specificity of their measures where possible.

Rationale for Students Preparation and Entrepreneurship Education in the Face of Global Economic Crisis in Nigeria

Science.gov (United States)

Onuma, Nwite

2016-01-01

The rationale for students preparation in job creation through entrepreneurship education was examined. Problems of unemployment among Nigerian university graduates and challenges to entrepreneurship in the face of global economic crisis were also highlighted. The persistent problem of unemployment among University graduates and its attendant…

Using Automated Processes to Generate Test Items And Their Associated Solutions and Rationales to Support Formative Feedback

Directory of Open Access Journals (Sweden)

Mark Gierl

2015-08-01

Full Text Available Automatic item generation is the process of using item models to produce assessment tasks using computer technology. An item model is similar to a template that highlights the elements in the task that must be manipulated to produce new items. The purpose of our study is to describe an innovative method for generating large numbers of diverse and heterogeneous items along with their solutions and associated rationales to support formative feedback. We demonstrate the method by generating items in two diverse content areas, mathematics and nonverbal reasoning

Quality Assurance for Clinical Trials

Science.gov (United States)

Ibbott, Geoffrey S.; Haworth, Annette; Followill, David S.

2013-01-01

Cooperative groups, of which the Radiation Therapy Oncology Group is one example, conduct national clinical trials that often involve the use of radiation therapy. In preparation for such a trial, the cooperative group prepares a protocol to define the goals of the trial, the rationale for its design, and the details of the treatment procedure to be followed. The Radiological Physics Center (RPC) is one of several quality assurance (QA) offices that is charged with assuring that participating institutions deliver doses that are clinically consistent and comparable. The RPC does this by conducting a variety of independent audits and credentialing processes. The RPC has compiled data showing that credentialing can help institutions comply with the requirements of a cooperative group clinical protocol. Phantom irradiations have been demonstrated to exercise an institution’s procedures for planning and delivering advanced external beam techniques (1–3). Similarly, RPC data indicate that a rapid review of patient treatment records or planning procedures can improve compliance with clinical trials (4). The experiences of the RPC are presented as examples of the contributions that a national clinical trials QA center can make to cooperative group trials. These experiences illustrate the critical need for comprehensive QA to assure that clinical trials are successful and cost-effective. The RPC is supported by grants CA 10953 and CA 81647 from the National Cancer Institute, NIH, DHHS. PMID:24392352

Engendering healthy masculinities to prevent sexual violence: Rationale for and design of the Manhood 2.0 trial.

Science.gov (United States)

Abebe, Kaleab Z; Jones, Kelley A; Culyba, Alison J; Feliz, Nayck B; Anderson, Heather; Torres, Irving; Zelazny, Sarah; Bamwine, Patricia; Boateng, Adwoa; Cirba, Benjamin; Detchon, Autumn; Devine, Danielle; Feinstein, Zoe; Macak, Justin; Massof, Michael; Miller-Walfish, Summer; Morrow, Sarah Elizabeth; Mulbah, Paul; Mulwa, Zabi; Paglisotti, Taylor; Ripper, Lisa; Ports, Katie A; Matjasko, Jennifer L; Garg, Aapta; Kato-Wallace, Jane; Pulerwitz, Julie; Miller, Elizabeth

2018-05-23

Violence against women and girls is an important global health concern. Numerous health organizations highlight engaging men and boys in preventing violence against women as a potentially impactful public health prevention strategy. Adapted from an international setting for use in the US, "Manhood 2.0" is a "gender transformative" program that involves challenging harmful gender and sexuality norms that foster violence against women while promoting bystander intervention (i.e., giving boys skills to interrupt abusive behaviors they witness among peers) to reduce the perpetration of sexual violence (SV) and adolescent relationship abuse (ARA). Manhood 2.0 is being rigorously evaluated in a community-based cluster-randomized trial in 21 lower resource Pittsburgh neighborhoods with 866 adolescent males ages 13-19. The comparison intervention is a job readiness training program which focuses on the skills needed to prepare youth for entering the workforce, including goal setting, accountability, resume building, and interview preparation. This study will provide urgently needed information about the effectiveness of a gender transformative program, which combines healthy sexuality education, gender norms change, and bystander skills to interrupt peers' disrespectful and harmful behaviors to reduce SV/ARA perpetration among adolescent males. In this manuscript, we outline the rationale for and evaluation design of Manhood 2.0. Clinical Trials #: NCT02427061. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Radiotherapy for pediatric brain tumors: Standard of care, current clinical trials, and new directions

International Nuclear Information System (INIS)

Kun, Larry E.

1996-01-01

cooperative group trials will be presented with reference to data re surgical, radiotherapeutic, and chemotherapeutic components of modern therapy. The outcome of supratentorial malignant gliomas and classical brainstem gliomas remains unacceptable; data from recent studies and planned protocols will be presented to highlight current treatment standards. The impact of tumor extent and resectability in ependymoma and craniopharyngioma will be reviewed to emphasize current practice, clinical investigations, and evolving debate regarding the role of radiation therapy and introduction of precision techniques. The rationale for recommended radiation volume(s) for intracranial germinomas will be reviewed, as well as recent data and proposed studies addressing combined chemoradiation for germ cell tumors. Recognizing the unique risk:benefit ration in treating infants and young children with both low grade and malignant brain tumors, the indications for radiation therapy, timing, and potential modifications of therapy will be highlighted

Genetic, clinical and pharmacological determinants of out-of-hospital cardiac arrest : rationale and outline of the AmsteRdam Resuscitation Studies (ARREST) registry

NARCIS (Netherlands)

Blom, M T; van Hoeijen, D A; Bardai, A; Berdowski, J; Souverein, P C; De Bruin, M L; Koster, R W; de Boer, A; Tan, H L

2014-01-01

INTRODUCTION: Out-of-hospital cardiac arrest (OHCA) is a major public health problem. Recognising the complexity of the underlying causes of OHCA in the community, we aimed to establish the clinical, pharmacological, environmental and genetic factors and their interactions that may cause OHCA.

Utility as a rationale for choosing observer performance assessment paradigms for detection tasks in medical imaging.

Science.gov (United States)

Wunderlich, Adam; Abbey, Craig K

2013-11-01

Studies of lesion detectability are often carried out to evaluate medical imaging technology. For such studies, several approaches have been proposed to measure observer performance, such as the receiver operating characteristic (ROC), the localization ROC (LROC), the free-response ROC (FROC), the alternative free-response ROC (AFROC), and the exponentially transformed FROC (EFROC) paradigms. Therefore, an experimenter seeking to carry out such a study is confronted with an array of choices. Traditionally, arguments for different approaches have been made on the basis of practical considerations (statistical power, etc.) or the gross level of analysis (case-level or lesion-level). This article contends that a careful consideration of utility should form the rationale for matching the assessment paradigm to the clinical task of interest. In utility theory, task performance is commonly evaluated with total expected utility, which integrates the various event utilities against the probability of each event. To formalize the relationship between expected utility and the summary curve associated with each assessment paradigm, the concept of a "natural" utility structure is proposed. A natural utility structure is defined for a summary curve when the variables associated with the summary curve axes are sufficient for computing total expected utility, assuming that the disease prevalence is known. Natural utility structures for ROC, LROC, FROC, AFROC, and EFROC curves are introduced, clarifying how the utilities of correct and incorrect decisions are aggregated by summary curves. Further, conditions are given under which general utility structures for localization-based methodologies reduce to case-based assessment. Overall, the findings reveal how summary curves correspond to natural utility structures of diagnostic tasks, suggesting utility as a motivating principle for choosing an assessment paradigm.

Bringing ayahuasca to the clinical research laboratory.

Science.gov (United States)

Riba, Jordi; Barbanoj, Manel J

2005-06-01

Since the winter of 1999, the authors and their research team have been conducting clinical studies involving the administration of ayahuasca to healthy volunteers. The rationale for conducting this kind of research is twofold. First, the growing interest of many individuals for traditional indigenous practices involving the ingestion of natural psychotropic drugs such as ayahuasca demands the systematic study of their pharmacological profiles in the target species, i.e., human beings. The complex nature of ayahuasca brews combining a large number of pharmacologically active compounds requires that research be carried out to establish the safety and overall pharmacological profile of these products. Second, the authors believe that the study of psychedelics in general calls for renewed attention. Although the molecular and electrophysiological level effects of these drugs are relatively well characterized, current knowledge of the mechanisms by which these compounds modify the higher order cognitive processes in the way they do is still incomplete, to say the least. The present article describes the development of the research effort carried out at the Autonomous University of Barcelona, commenting on several methodological aspects and reviewing the basic clinical findings. It also describes the research currently underway in our laboratory, and briefly comments on two new studies we plan to undertake in order to further our knowledge of the pharmacology of ayahuasca.

RETHINKING THE ROLE OF CLINICAL TRIAL DATA IN INTERNATIONAL INTELLECTUAL PROPERTY LAW: THE CASE FOR A PUBLIC GOODS APPROACH

OpenAIRE

REICHMAN, JEROME H.

2009-01-01

This article describes the growth and consequences of new intellectual property rights given to pharmaceutical developers, and it advocates treating clinical trials as a public good. Although the soaring cost of clinical trials is well known and discussed, too little attention is given to the underlying rationale for allowing drug developers to recoup their costs through the new intellectual property rights provided in multilateral, regional, and bilateral agreements. Known in the US as “mark...

A study on job satisfaction among clinical and non-clinical hospital ...

African Journals Online (AJOL)

Methods: Two hundred clinical and non-clinical hospital staff were invited to take part in the study. They completed a sociodemographic questionnaire and the Job Descriptive Index (JDI). Results: The results indicated that majority clinical and non-clinical staff were satisfied with their jobs as regards the parameters of the ...

Uncertainty sources in radiopharmaceuticals clinical studies

International Nuclear Information System (INIS)

Degenhardt, Aemilie Louize; Oliveira, Silvia Maria Velasques de

2014-01-01

The radiopharmaceuticals should be approved for consumption by evaluating their quality, safety and efficacy. Clinical studies are designed to verify the pharmacodynamics, pharmacological and clinical effects in humans and are required for assuring safety and efficacy. The Bayesian analysis has been used for clinical studies effectiveness evaluation. This work aims to identify uncertainties associated with the process of production of the radionuclide and radiopharmaceutical labelling as well as the radiopharmaceutical administration and scintigraphy images acquisition and processing. For the development of clinical studies in the country, the metrological chain shall assure the traceability of the surveys performed in all phases. (author)

Fusion-fission hybrids: environmental aspects and their role in hybrid rationale

International Nuclear Information System (INIS)

Holdren, J.P.

1981-01-01

The rationale for developing hybrids depends on real or perceived liabilities of relying on pure fission to do the same job. Quite possibly the main constraint on expanded use of fission will be neither lack of fuel nor high costs, but perceived environmental liabilities - radioactive wastes, reactor safety, and links to nuclear weaponry. The environmental characteristics of hybrid systems and pure-fisson systems are compared here in detail. The findings are that significant environmental advantages for hybrids cannot now be demonstrated and may not exist. Therefore, if environmental drawbacks constrain the application of pure fission, hybrids probably also will be thus constrained

Infliximab Dose Reduction Sustains the Clinical Treatment Effect in Active HLAB27 Positive Ankylosing Spondylitis: A Two-Year Pilot Study

Directory of Open Access Journals (Sweden)

Boel Mörck

2013-01-01

Full Text Available The rationale of the study was to evaluate the efficacy of infliximab (IFX treatment in patients with ankylosing spondylitis (AS and to determine whether IFX dose reduction and interval extension sustains the treatment effect. Nineteen patients were included and treated with IFX 5 mg/kg every 6 weeks for 56 weeks. All patients concomitantly received MTX with median dose 7.5 mg/weekly. During the second year, the IFX dose was reduced to 3 mg/kg every 8 weeks. Eighteen patients completed the 1-year and 15 patients the 2-year trial. The ≥50% improvement at week 16 from baseline of BASDAI was achieved in 16/19 (84% patients. Significant reductions in BASDAI, BASFI, and BASMI scores, decrease in ESR and CRP, and improvement in SF-36 were observed at weeks 16 and 56. The MRI-defined inflammatory changes in the sacroiliac joints disappeared in 10/15 patients (67% already at 16 weeks. IFX treatment effect was sustained throughout the second year after IFX dose reduction and interval extension. We conclude that IFX treatment is effective in well-established active AS and a dose reduction sustains the treatment effect. These observations are of clinical importance and open the opportunity to reduce the drug costs. This trial is registered with ClinicalTrials.gov NCT01850121.

Standards for Clinical Trials in Male and Female Sexual Dysfunction: I. Phase I to Phase IV Clinical Trial Design.

Science.gov (United States)

Fisher, William A; Gruenwald, Ilan; Jannini, Emmanuele A; Lev-Sagie, Ahinoam; Lowenstein, Lior; Pyke, Robert E; Reisman, Yakov; Revicki, Dennis A; Rubio-Aurioles, Eusebio

2016-12-01

This series of articles outlines standards for clinical trials of treatments for male and female sexual dysfunctions, with a focus on research design and patient-reported outcome assessment. These articles consist of revision, updating, and integration of articles on standards for clinical trials in male and female sexual dysfunction from the 2010 International Consultation on Sexual Medicine developed by the authors as part of the 2015 International Consultation on Sexual Medicine. We are guided in this effort by several principles. In contrast to previous versions of these guidelines, we merge discussion of standards for clinical trials in male and female sexual dysfunction in an integrated approach that emphasizes the common foundational practices that underlie clinical trials in the two settings. We present a common expected standard for clinical trial design in male and female sexual dysfunction, a common rationale for the design of phase I to IV clinical trials, and common considerations for selection of study population and study duration in male and female sexual dysfunction. We present a focused discussion of fundamental principles in patient- (and partner-) reported outcome assessment and complete this series of articles with specific discussions of selected aspects of clinical trials that are unique to male and to female sexual dysfunction. Our consideration of standards for clinical trials in male and female sexual dysfunction attempts to embody sensitivity to existing and new regulatory guidance and to address implications of the evolution of the diagnosis of sexual dysfunction that have been brought forward in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. The first article in this series focuses on phase I to phase IV clinical trial design considerations. Subsequent articles in this series focus on the measurement of patient-reported outcomes, unique aspects of clinical trial design for men, and unique aspects of clinical

Challenges and opportunities in designing clinical trials for neuromyelitis optica

Science.gov (United States)

Barron, Gerard; Behne, Jacinta M.; Bennett, Jeffery L.; Chin, Peter S.; Cree, Bruce A.C.; de Seze, Jerome; Flor, Armando; Fujihara, Kazuo; Greenberg, Benjamin; Higashi, Sayumi; Holt, William; Khan, Omar; Knappertz, Volker; Levy, Michael; Melia, Angela T.; Palace, Jacqueline; Smith, Terry J.; Sormani, Maria Pia; Van Herle, Katja; VanMeter, Susan; Villoslada, Pablo; Walton, Marc K.; Wasiewski, Warren; Wingerchuk, Dean M.; Yeaman, Michael R.

2015-01-01

Current management of neuromyelitis optica (NMO) is noncurative and only partially effective. Immunosuppressive or immunomodulatory agents are the mainstays of maintenance treatment. Safer, better-tolerated, and proven effective treatments are needed. The perceived rarity of NMO has impeded clinical trials for this disease. However, a diagnostic biomarker and recognition of a wider spectrum of NMO presentations has expanded the patient population from which study candidates might be recruited. Emerging insights into the pathogenesis of NMO have provided rationale for exploring new therapeutic targets. Academic, pharmaceutical, and regulatory communities are increasingly interested in meeting the unmet needs of patients with NMO. Clinical trials powered to yield unambiguous outcomes and designed to facilitate rapid evaluation of an expanding pipeline of experimental agents are needed. NMO-related disability occurs incrementally as a result of attacks; thus, limiting attack frequency and severity are critical treatment goals. Yet, the severity of NMO and perception that currently available agents are effective pose challenges to study design. We propose strategies for NMO clinical trials to evaluate agents targeting recovery from acute attacks and prevention of relapses, the 2 primary goals of NMO treatment. Aligning the interests of all stakeholders is an essential step to this end. PMID:25841026

The WRITTEN-HEART study (expressive writing for heart healing): rationale and design of a randomized controlled clinical trial of expressive writing in coronary patients referred to residential cardiac rehabilitation

Science.gov (United States)

2011-01-01

Background Coronary heart disease (CHD) is typically associated with many cardiovascular risk factors (e.g., elevated blood pressure), low health-related quality of life, depression, anxiety and psychological stress. Expressive writing (EW) has shown beneficial effects on such variables in both people from the community and in patients with a variety of chronic illnesses. However, no study to date has evaluated the physical and psychological effects of the expressive writing procedure on coronary patients referred to cardiac rehabilitation (CR). Methods The clinical effectiveness of a 2-week disease-related expressive writing procedure (writing about one's deepest thoughts and feelings regarding the experience with heart disease) compared with the standard writing task (writing about one's deepest thoughts and feelings about the most traumatic or negative event experienced in the life), a neutral writing condition (writing about the facts regarding heart disease and its treatment) and an empty control condition will be evaluated in a randomized controlled clinical trial (RCT) with repeated follow-up measurements at 3, 6 and 12 months after discharge from CR. The primary outcome is health-related quality of life (SF-12). Secondary outcome measures are depression (BDI-II), anxiety (BAI) and post-traumatic growth (PTGI). Furthermore, the study will explore the moderating effects of coping styles, type D personality, perceived emotional support and participants' evaluative ratings of the writing interventions on the main experimental effects in order to identify sub-groups of patients showing different results. Discussion The WRITTEN-HEART study aims to explore and expand the frontiers of the expressive writing research enterprise by investigating the feasibility, safety and clinical efficacy of brief and cost-effective expressive writing interventions in patients with CHD referred to CR. Trial registration ClinicalTrials.gov NCT01253486 PMID:21740564

Tracing the Rationale Behind UML Model Change Through Argumentation

Science.gov (United States)

Jureta, Ivan J.; Faulkner, Stéphane

Neglecting traceability—i.e., the ability to describe and follow the life of a requirement—is known to entail misunderstanding and miscommunication, leading to the engineering of poor quality systems. Following the simple principles that (a) changes to UML model instances ought be justified to the stakeholders, (b) justification should proceed in a structured manner to ensure rigor in discussions, critique, and revisions of model instances, and (c) the concept of argument instantiated in a justification process ought to be well defined and understood, the present paper introduces the UML Traceability through Argumentation Method (UML-TAM) to enable the traceability of design rationale in UML while allowing the appropriateness of model changes to be checked by analysis of the structure of the arguments provided to justify such changes.

Violence risk prediction. Clinical and actuarial measures and the role of the Psychopathy Checklist.

Science.gov (United States)

Dolan, M; Doyle, M

2000-10-01

Violence risk prediction is a priority issue for clinicians working with mentally disordered offenders. To review the current status of violence risk prediction research. Literature search (Medline). Key words: violence, risk prediction, mental disorder. Systematic/structured risk assessment approaches may enhance the accuracy of clinical prediction of violent outcomes. Data on the predictive validity of available clinical risk assessment tools are based largely on American and North American studies and further validation is required in British samples. The Psychopathy Checklist appears to be a key predictor of violent recidivism in a variety of settings. Violence risk prediction is an inexact science and as such will continue to provoke debate. Clinicians clearly need to be able to demonstrate the rationale behind their decisions on violence risk and much can be learned from recent developments in research on violence risk prediction.

Renal Denervation for Chronic Heart Failure: Background and Pathophysiological Rationale.

Science.gov (United States)

Böhm, Michael; Ewen, Sebastian; Mahfoud, Felix

2017-01-01

The activation of the sympathetic nervous system is associated with cardiovascular hospitalizations and death in heart failure. Renal denervation has been shown to effectively reduce sympathetic overdrive in certain patients with uncontrolled hypertension. Pilot trials investigating renal denervation as a potential treatment approach for heart failure were initiated. Heart failure comorbidities like obstructive sleep apnea, metabolic syndrome and arrhythmias could also be targets for renal denervation, because these occurrences are also mediated by the activation of the sympathetic nervous system. Therefore, renal denervation in heart failure is worthy of further investigation, although its effectiveness still has to be proven. Herein, we describe the pathophysiological rationale and the effect of renal denervation on surrogates of the heart failure syndrome.

An investigation of pre-activity cardiovascular screening procedures in health/fitness facilities--part II: rationale for low adherence with national standards.

Science.gov (United States)

Springer, Judy B; Eickhoff-Shemek, JoAnn M; Zuberbuehler, Ernest J

2009-01-01

The purpose of this study was to explore the rationale provided by program directors and general managers of health/fitness facilities for low adherence to nationally accepted standards related to pre-activity cardiovascular screening procedures (PACSPs) for members and clients of personal trainers. Qualitative interviews were conducted with the directors/managers in a Midwest region representing 76 facilities who indicated they did not conduct PACSPs for members and clients of personal trainers. Analysis of the rationale provided revealed 6 major clusters: (1) Purpose or need for screening; (2) time and staffing; (3) barrier to participation; (4) personal responsibility for health and actions; (5) legal issues; and (6) company or franchise policy that categorized the reasons for low adherence to PACSPs. These findings highlight the need to increase awareness of the relevance of PACSPs among health/fitness managers, staff members, and current exercise science students as well as engage those in risk management for informed dialogue for consistent application of the standard of care. Copyright 2009 Wiley Periodicals, Inc.

Rationale and design of XAMOS

DEFF Research Database (Denmark)

Turpie, Alexander G G; Schmidt, André C; Kreutz, Reinhold

2012-01-01

, noninterventional, parallel-group study to gain insight into the safety (major bleeding, side effects) and effectiveness (prevention of symptomatic thromboembolic events) of rivaroxaban in daily clinical practice. XAMOS will follow 15,000 patients after major orthopedic surgery in approximately 200 centers...

The new Childhood Arthritis and Rheumatology Research Alliance (CARRA) registry: design, rationale, and characteristics of patients enrolled in the first 12 months.

Science.gov (United States)

Beukelman, Timothy; Kimura, Yukiko; Ilowite, Norman T; Mieszkalski, Kelly; Natter, Marc D; Burrell, Grendel; Best, Brian; Jones, Jason; Schanberg, Laura E

2017-04-17

Herein we describe the history, design, and rationale of the new Childhood Arthritis and Rheumatology Research Alliance (CARRA) Registry and present the characteristics of patients with juvenile idiopathic arthritis (JIA) enrolled in the first 12 months of operation. The CARRA Registry began prospectively collecting data in the United States and Canada in July 2015 to evaluate the safety of therapeutic agents in persons with childhood-onset rheumatic disease, initially restricted to JIA. Secondary objectives include the evaluation of disease outcomes and their associations with medication use and other factors. Data are collected every 6 months and include clinical assessments, detailed medication use, patient-reported outcomes, and safety events. Follow-up is planned for at least 10 years for each participant and is facilitated by a telephone call center. As of July 2016, 1192 patients with JIA were enrolled in the CARRA Registry at 49 clinical sites. At enrollment, their median age was 12.4 years old and median disease duration was 2.6 years. Owing to preferential enrollment, patients with systemic JIA (13%) and with a polyarticular course (75%) were over-represented compared to patients in typical clinical practice. Approximately 49% were currently using biologic agents and ever use of oral glucocorticoids was common (47%). The CARRA Registry provides safety surveillance data to pharmaceutical companies to satisfy their regulatory requirements, and several independently-funded sub-studies that use the Registry infrastructure are underway. The new CARRA Registry successfully enrolled nearly 1200 participants with JIA in the first 12 months of its operation. Sustainable funding has been secured from multiple sources. The CARRA Registry may serve as a model for the study of other uncommon diseases.

Forensic psychiatric nursing: skills and competencies: II clinical aspects.

Science.gov (United States)

Mason, T; Coyle, D; Lovell, A

2008-03-01

This study reports on research undertaken to identify the skills and competencies of forensic psychiatric nurses working in secure psychiatric services in the UK. The rationale for this research is the lack of clarity in the role definition of nurses working in these environments and the specific content that may underscore the curriculum for training forensic nurses. Over 3300 questionnaires were distributed to forensic psychiatric nurses, non-forensic psychiatric nurses and other disciplines and information obtained on (1) the perceived clinical problems that give forensic nurses the most difficulty; (2) the skills best suited to overcome those problems; and (3) the priority aspects of clinical nursing care that needs to be developed. A 35% response rate was obtained with 1019 forensic psychiatric nurses, 110 non-forensic psychiatric nurses and 43 other disciplines. The results highlighted a 'top ten' list of main problems with possible solutions and main areas for development. The conclusions drawn include a focus on skills and competencies regarding the management of personality disorders and the management of violence and aggression.

Targeted therapies for non-small-cell lung cancer: biology, rationale, and preclinical results from a radiation oncology perspective

International Nuclear Information System (INIS)

Raben, David; Helfrich, Barb; Bunn, Paul A.

2004-01-01

The epidermal growth factor receptor (EGFR) is overexpressed in the majority of non-small-cell lung cancers (NSCLCs). This presents an opportune target for new treatment strategies designed to selectively interfere with the cancer cell growth cycle. Recent investigations into the biology of the EGFR and its downstream signaling pathways have reminded us of the complexity of cancer cell communications from the cytoplasm to the nucleus. Multiple pathways are activated with stimulation of the autocrine and paracrine EGFR loop, from the ras-raf-MEK activation of ERK 1/2 to the P13K-Akt pathway, each playing an important role in cancer cell survival, invasion, and angiogenesis. Preclinical studies have demonstrated that molecules targeting the EGFR, either through extracellular blockade or intracellular interference with the EGFR-associated tyrosine kinase, reversibly or irreversibly, inhibit cancer cell growth. Potent antitumor effects have been observed in human tumor xenograft models. Preclinical studies have also demonstrated cooperative effects when anti-EGFR agents are combined with radiation or chemotherapy. Many of these agents have now entered into advanced human clinical trials with modest dose-related toxicity despite chronic administration. Encouraging response rates with single-agent targeted therapy have been reported in heavily pretreated patients with advanced NSCLC. In addition, agents targeting the angiogenic pathway, which plays a key role in the regulation of angiogenesis, may play an important role in enhancing the efficacy of anti-EGFR agents. This article will focus on the biology, rationale, and preclinical studies with targeted anti-EGFR and antiangiogenic therapies for the management of NSCLC

The Scandinavian baltic pancreatic club (SBPC) database: design, rationale and characterisation of the study cohort.

Science.gov (United States)

Olesen, Søren S; Poulsen, Jakob L; Drewes, Asbjørn M; Frøkjær, Jens B; Laukkarinen, Johanna; Parhiala, Mikael; Rix, Iben; Novovic, Srdan; Lindkvist, Björn; Bexander, Louise; Dimcevski, Georg; Engjom, Trond; Erchinger, Friedemann; Haldorsen, Ingfrid S; Pukitis, Aldis; Ozola-Zālīte, Imanta; Haas, Stephan; Vujasinovic, Miroslav; Löhr, J Matthias; Gulbinas, Antanas; Jensen, Nanna M; Jørgensen, Maiken T; Nøjgaard, Camilla

2017-08-01

Chronic pancreatitis (CP) is a multifaceted disease associated with several risk factors and a complex clinical presentation. We established the Scandinavian Baltic Pancreatic Club (SBPC) Database to characterise and study the natural history of CP in a Northern European cohort. Here, we describe the design of the database and characteristics of the study cohort. Nine centres from six different countries in the Scandinavian-Baltic region joined the database. Patients with definitive or probable CP (M-ANNHEIM diagnostic criteria) were included. Standardised case report forms were used to collect several assessment variables including disease aetiology, duration of CP, preceding acute pancreatitis, as well as symptoms, complications, and treatments. The clinical stage of CP was characterised according to M-ANNNHEIM. Yearly follow-up is planned for all patients. The study cohort comprised of 910 patients (608 men: 302 women; median age 58 (IQR: 48-67) years with definite 848 (93%) or probable CP 62 (7%). Nicotine (70%) and alcohol (59%) were the most frequent aetiologies and seen in combination in 44% of patients. A history of recurrent acute pancreatitis was seen in 49% prior to the development of CP. Pain (69%) and exocrine pancreatic insufficiency (68%) were the most common complications followed by diabetes (43%). Most patients (30%) were classified as clinical stage II (symptomatic CP with exocrine or endocrine insufficiency). Less than 10% of the patients had undergone pancreatic surgery. The SBPC database provides a mean for future prospective, observational studies of CP in the Northern European continent.

Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact.

Science.gov (United States)

Curran, Geoffrey M; Bauer, Mark; Mittman, Brian; Pyne, Jeffrey M; Stetler, Cheryl

2012-03-01

This study proposes methods for blending design components of clinical effectiveness and implementation research. Such blending can provide benefits over pursuing these lines of research independently; for example, more rapid translational gains, more effective implementation strategies, and more useful information for decision makers. This study proposes a "hybrid effectiveness-implementation" typology, describes a rationale for their use, outlines the design decisions that must be faced, and provides several real-world examples. An effectiveness-implementation hybrid design is one that takes a dual focus a priori in assessing clinical effectiveness and implementation. We propose 3 hybrid types: (1) testing effects of a clinical intervention on relevant outcomes while observing and gathering information on implementation; (2) dual testing of clinical and implementation interventions/strategies; and (3) testing of an implementation strategy while observing and gathering information on the clinical intervention's impact on relevant outcomes. The hybrid typology proposed herein must be considered a construct still in evolution. Although traditional clinical effectiveness and implementation trials are likely to remain the most common approach to moving a clinical intervention through from efficacy research to public health impact, judicious use of the proposed hybrid designs could speed the translation of research findings into routine practice.

Mesotherapy, definition, rationale and clinical role: a consensus report from the Italian Society of Mesotherapy.

Science.gov (United States)

Mammucari, M; Gatti, A; Maggiori, S; Bartoletti, C A; Sabato, A F

2011-06-01

Since its introduction in the 1950s, the use of mesotherapy has generated much interest among clinicians and patients. The Italian Society of Mesotherapy (SIM) brought together a panel of experts to review available evidence and to draw up a series of recommendations on the use of intradermal therapy (LIT) in clinical practice. There was overwhelming agreement among Consensus Group members that, when used correctly, LIT is a valuable therapeutic option in the treatment of painful, loco-regional conditions. They also emphasised that the clinical efficacy of LIT has been demonstrated in the management of chronic venous lymphatic insufficiency, oedematous fibrosclerotic panniculopathy and facial skin aging. The experts were unanimous on the use of LIT in vaccination. Mesotherapy is not a substitute for other therapeutic options and should only be used when the patient has been fully informed of its advantages and limitations. Likewise the procedure should only be carried out by an experienced qualified physician. Although there was widespread agreement among the Consensus Group on the place of LIT in several indications, the Authors reiterated the need for more large-scale clinical trials to determine the specific benefits and limitations in some areas of the application of intradermal therapy.

Advanced control room evaluation: General approach and rationale

International Nuclear Information System (INIS)

O'Hara, J.M.; Wachtel, J.

1991-01-01

Advanced control rooms (ACRs) for future nuclear power plants (NPPs) are being designed utilizing computer-based technologies. The US Nuclear Regulatory Commission reviews the human engineering aspects of such control rooms to ensure that they are designed to good human factors engineering principles and that operator performance and reliability are appropriately supported in order to protect public health and safety. This paper describes the rationale and general approach to the development of a human factors review guideline for ACRs. The factors influencing the guideline development are discussed, including the review environment, the types of advanced technologies being addressed, the human factors issues associated with advanced technology, and the current state-of-the-art of human factors guidelines for advanced human-system interfaces (HSIs). The proposed approach to ACR review would track the design and implementation process through the application of review guidelines reflecting four review modules: planning, design process analysis, human factors engineering review, and dynamic performance evaluation. 21 refs

The Managed Ventricular pacing versus VVI 40 Pacing (MVP) Trial: clinical background, rationale, design, and implementation.

Science.gov (United States)

Sweeney, Michael O; Ellenbogen, Kenneth A; Miller, Elaine Hogan; Sherfesee, Lou; Sheldon, Todd; Whellan, David

2006-12-01

Implantable cardioverter defibrillators (ICDs) reduce mortality among appropriately selected patients who have had or are at risk for life-threatening ventricular arrhythmia. Right ventricular apical (RVA) pacing has been implicated in worsening heart failure and death. The optimal pacemaker mode for bradycardia support while minimizing unnecessary and potentially harmful RVA pacing has not been determined. The Managed Ventricular pacing vs. VVI 40 Pacing Trial (MVP) is a prospective, multicenter, randomized, single-blind, parallel, controlled clinical trial designed to establish whether atrial-based dual-chamber managed ventricular pacing mode (MVP) is equivalent or superior to back-up only ventricular pacing (VVI 40) among patients with standard indications for ICD therapy and no indication for bradycardia pacing. The MVP Trial is designed with 80% power to detect a 10% reduction in the primary endpoint of new or worsening heart failure or all-cause mortality in the MVP-treated group. Approximately 1,000 patients at 80 centers in the United States, Canada, Western Europe, and Israel will be randomized to MVP or VVI 40 pacing after successful implantation of a dual-chamber ICD. Heart failure therapies will be optimized in accordance with evidence-based guidelines. Prespecified secondary endpoints will include ventricular arrhythmias, atrial fibrillation, new indication for bradycardia pacing, health-related quality of life, and cost effectiveness. Enrollment began in October 2004 and concluded in April 2006. The study will be terminated upon recommendation of the Data Monitoring Committee or when the last patient enrolled and surviving has reached a minimum 2 years of follow-up. The MVP Trial will meet the clinical need for carefully designed prospective studies to define the benefits of atrial-based dual-chamber minimal ventricular pacing versus single-chamber ventricular pacing in conventional ICD patients.

Working Inside for Smoking Elimination (Project W.I.S.E. study design and rationale to prevent return to smoking after release from a smoke free prison

Directory of Open Access Journals (Sweden)

Mello Jennifer

2011-10-01

Full Text Available Abstract Background Incarcerated individuals suffer disproportionately from the health effects of tobacco smoking due to the high smoking prevalence in this population. In addition there is an over-representation of ethnic and racial minorities, impoverished individuals, and those with mental health and drug addictions in prisons. Increasingly, prisons across the U.S. are becoming smoke free. However, relapse to smoking is common upon release from prison, approaching 90% within a few weeks. No evidence based treatments currently exist to assist individuals to remain abstinent after a period of prolonged, forced abstinence. Methods/Design This paper describes the design and rationale of a randomized clinical trial to enhance smoking abstinence rates among individuals following release from a tobacco free prison. The intervention is six weekly sessions of motivational interviewing and cognitive behavioral therapy initiated approximately six weeks prior to release from prison. The control group views six time matched videos weekly starting about six weeks prior to release. Assessments take place in-person 3 weeks after release and then for non-smokers every 3 months up to 12 months. Smoking status is confirmed by urine cotinine. Discussion Effective interventions are greatly needed to assist these individuals to remain smoke free and reduce health disparities among this socially and economically challenged group. Trial Registration NCT01122589

Clinical Outcomes Used in Clinical Pharmacy Intervention Studies in Secondary Care

Directory of Open Access Journals (Sweden)

Lene Juel Kjeldsen

2017-05-01

Full Text Available The objective was to investigate type, frequency and result of clinical outcomes used in studies to assess the effect of clinical pharmacy interventions in inpatient care. The literature search using Pubmed.gov was performed for the period up to 2013 using the search phrases: “Intervention(s” and “pharmacist(s” and “controlled” and “outcome(s” or “effect(s”. Primary research studies in English of controlled, clinical pharmacy intervention studies, including outcome evaluation, were selected. Titles, abstracts and full-text papers were assessed individually by two reviewers, and inclusion was determined by consensus. In total, 37 publications were included in the review. The publications presented similar intervention elements but differed in study design. A large variety of outcome measures (135 had been used to evaluate the effect of the interventions; most frequently clinical measures/assessments by physician and health care service use. No apparent pattern was established among primary outcome measures with significant effect in favour of the intervention, but positive effect was most frequently related to studies that included power calculations and sufficient inclusion of patients (73% vs. 25%. This review emphasizes the importance of considering the relevance of outcomes selected to assess clinical pharmacy interventions and the importance of conducting a proper power calculation.

Integrating utilization-focused evaluation with business process modeling for clinical research improvement.

Science.gov (United States)

Kagan, Jonathan M; Rosas, Scott; Trochim, William M K

2010-10-01

New discoveries in basic science are creating extraordinary opportunities to design novel biomedical preventions and therapeutics for human disease. But the clinical evaluation of these new interventions is, in many instances, being hindered by a variety of legal, regulatory, policy and operational factors, few of which enhance research quality, the safety of study participants or research ethics. With the goal of helping increase the efficiency and effectiveness of clinical research, we have examined how the integration of utilization-focused evaluation with elements of business process modeling can reveal opportunities for systematic improvements in clinical research. Using data from the NIH global HIV/AIDS clinical trials networks, we analyzed the absolute and relative times required to traverse defined phases associated with specific activities within the clinical protocol lifecycle. Using simple median duration and Kaplan-Meyer survival analysis, we show how such time-based analyses can provide a rationale for the prioritization of research process analysis and re-engineering, as well as a means for statistically assessing the impact of policy modifications, resource utilization, re-engineered processes and best practices. Successfully applied, this approach can help researchers be more efficient in capitalizing on new science to speed the development of improved interventions for human disease.

Supplementation of iron in pulmonary hypertension: Rationale and design of a phase II clinical trial in idiopathic pulmonary arterial hypertension

Science.gov (United States)

Howard, Luke S.G.E.; Watson, Geoffrey M.J.; Wharton, John; Rhodes, Christopher J.; Chan, Kakit; Khengar, Rajeshree; Robbins, Peter A.; Kiely, David G.; Condliffe, Robin; Elliott, Charlie A.; Pepke-Zaba, Joanna; Sheares, Karen; Morrell, Nicholas W.; Davies, Rachel; Ashby, Deborah; Gibbs, J. Simon R.; Wilkins, Martin R.

2013-01-01

Our aim is to assess the safety and potential clinical benefit of intravenous iron (Ferinject) infusion in iron deficient patients with idiopathic pulmonary arterial hypertension (IPAH). Iron deficiency in the absence of anemia (1) is common in patients with IPAH; (2) is associated with inappropriately raised levels of hepcidin, the key regulator of iron homeostasis; and (3) correlates with disease severity and worse clinical outcomes. Oral iron absorption may be impeded by reduced absorption due to elevated hepcidin levels. The safety and benefits of parenteral iron replacement in IPAH are unknown. Supplementation of Iron in Pulmonary Hypertension (SIPHON) is a Phase II, multicenter, double-blind, randomized, placebo-controlled, crossover clinical trial of iron in IPAH. At least 60 patients will be randomized to intravenous ferric carboxymaltose (Ferinject) or saline placebo with a crossover point after 12 weeks of treatment. The primary outcome will be the change in resting pulmonary vascular resistance from baseline at 12 weeks, measured by cardiac catheterization. Secondary measures include resting and exercise hemodynamics and exercise performance from serial bicycle incremental and endurance cardiopulmonary exercise tests. Other secondary measurements include serum iron indices, 6-Minute Walk Distance, WHO functional class, quality of life score, N-terminal pro-brain natriuretic peptide (NT-proBNP), and cardiac anatomy and function from cardiac magnetic resonance. We propose that intravenous iron replacement will improve hemodynamics and clinical outcomes in IPAH. If the data supports a potentially useful therapeutic effect and suggest this drug is safe, the study will be used to power a Phase III study to address efficacy. PMID:23662181

The Rationale of Crisis Management – On the Handling of Coincidence in Economic Situation

Directory of Open Access Journals (Sweden)

Peter Bendixen

2010-07-01

Full Text Available The subject of this essay is too complex a problem as to cover all details in depth and, thus, draws its attention only to core aspects of the handling of coincidence leaving out sophisticated studies and analytic findings as well as detailed reference to economic literature though there is not very much. On the other hand, for a lot of actual as well as general reasons, the subject is too important a matter as to ignore the serious methodological problems of crisis management, which are rooted in some politically still active bias hidden in orthodox neo-classical economics (Stiglitz 2010. If crisis management continues to follow traditional rationales, it will fail realizing the increasing dynamic of crises within the globalising economies of the world. No existing economy can be considered as an isolated system of its own embedded in a stable composition of societal surroundings. Obviously, many a critical situation has its origin in the sphere of civilization, of political discrepancies, and of administrative inflexibilities. On the other hand, any grave amplitude of markets would touch the entire social surrounding. The belief in the markets’ strength of self-regulation is a dangerous construction of orthodox economics (Bendixen 2009b, 2010. The view on crises suggested here is that of a holistic approach to understand a critical situation. Any interpretation of a situation includes empirical dates and figures based on analytic research, but solving a problem is not an act of logical derivation from findings, as if a solution can be excavated in the mud of reality by empirical studies only. Empirical figures report events of the past; the future does not reveal any empiricism. This would be a contradiction in itself. The end of a crisis as well as the search for solutions to fight the problems revealed is unavoidably a view into the future. Therefore, the rationale of crisis management cannot be made of pure empiricism but should include a

Design of Phase I Combination Trials: Recommendations of the Clinical Trial Design Task Force of the NCI Investigational Drug Steering Committee

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Paller, Channing J.; Bradbury, Penelope A.; Ivy, S. Percy; Seymour, Lesley; LoRusso, Patricia M.; Baker, Laurence; Rubinstein, Larry; Huang, Erich; Collyar, Deborah; Groshen, Susan; Reeves, Steven; Ellis, Lee M.; Sargent, Daniel J.; Rosner, Gary L.; LeBlanc, Michael L.; Ratain, Mark J.

2014-01-01

Anticancer drugs are combined in an effort to treat a heterogeneous tumor or to maximize the pharmacodynamic effect. The development of combination regimens, while desirable, poses unique challenges. These include the selection of agents for combination therapy that may lead to improved efficacy while maintaining acceptable toxicity, the design of clinical trials that provide informative results for individual agents and combinations, and logistical and regulatory challenges. The phase 1 trial is often the initial step in the clinical evaluation of a combination regimen. In view of the importance of combination regimens and the challenges associated with developing them, the Clinical Trial Design (CTD) Task Force of the National Cancer Institute (NCI) Investigational Drug Steering Committee developed a set of recommendations for the phase 1 development of a combination regimen. The first two recommendations focus on the scientific rationale and development plans for the combination regimen; subsequent recommendations encompass clinical design aspects. The CTD Task Force recommends that selection of the proposed regimens be based on a biological or pharmacological rationale supported by clinical and/or robust and validated preclinical evidence, and accompanied by a plan for subsequent development of the combination. The design of the phase 1 clinical trial should take into consideration the potential pharmacokinetic and pharmacodynamic interactions as well as overlapping toxicity. Depending on the specific hypothesized interaction, the primary endpoint may be dose optimization, pharmacokinetics, and/or pharmacodynamic (i.e., biomarker). PMID:25125258

Rationale and Description of Right Ventricle-Protective Ventilation in ARDS.

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Paternot, Alexis; Repessé, Xavier; Vieillard-Baron, Antoine

2016-10-01

Pulmonary vascular dysfunction is associated with ARDS and leads to increased right-ventricular afterload and eventually right-ventricular failure, also called acute cor pulmonale. Interest in acute cor pulmonale and its negative impact on outcome in patients with ARDS has grown in recent years. Right-ventricular function in these patients should be closely monitored, and this is helped by the widespread use of echocardiography in intensive care units. Because mechanical ventilation may worsen right-ventricular failure, the interaction between the lungs and the right ventricle appears to be a key factor in the ventilation strategy. In this review, a rationale for a right ventricle-protective ventilation approach is provided, and such a strategy is described, including the reduction of lung stress (ie, the limitation of plateau pressure and driving pressure), the reduction of PaCO2 , and the improvement of oxygenation. Prone positioning seems to be a crucial part of this strategy by protecting both the lungs and the right ventricle, resulting in increased survival of patients with ARDS. Further studies are required to validate the positive impact on prognosis of right ventricle-protective mechanical ventilation. Copyright © 2016 by Daedalus Enterprises.

The NordiNet® International Outcome Study and NovoNet® ANSWER Program®: rationale, design, and methodology of two international pharmacoepidemiological registry-based studies monitoring long-term clinical and safety outcomes of growth hormone therapy (Norditropin®).

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Höybye, Charlotte; Sävendahl, Lars; Christesen, Henrik Thybo; Lee, Peter; Pedersen, Birgitte Tønnes; Schlumpf, Michael; Germak, John; Ross, Judith

2013-01-01

Randomized controlled trials have shown that growth hormone (GH) therapy has effects on growth, metabolism, and body composition. GH therapy is prescribed for children with growth failure and adults with GH deficiency. Carefully conducted observational study of GH treatment affords the opportunity to assess long-term treatment outcomes and the clinical factors and variables affecting those outcomes, in patients receiving GH therapy in routine clinical practice. The NordiNet® International Outcome Study (IOS) and the American Norditropin® Web Enabled Research (ANSWER Program®) are two complementary, non-interventional, observational studies that adhere to current guidelines for pharmacoepidemiological data. The studies include pediatric and adult patients receiving Norditropin®, as prescribed by their physicians. The studies gather long-term data on the safety and effectiveness of reallife treatment with the recombinant human GH, Norditropin®. We describe the origins, aims, objectives, and design methodology of the studies, as well as their governance and validity, strengths, and limitations. The NordiNet® IOS and ANSWER Program® studies will provide valid insights into the effectiveness and safety of GH treatment across a diverse and large patient population treated in accordance with real-world clinical practice and following the Good Pharmacoepidemiological Practice and STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) guidelines.

Renal Denervation for Chronic Heart Failure: Background and Pathophysiological Rationale

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Ewen, Sebastian; Mahfoud, Felix

2017-01-01

The activation of the sympathetic nervous system is associated with cardiovascular hospitalizations and death in heart failure. Renal denervation has been shown to effectively reduce sympathetic overdrive in certain patients with uncontrolled hypertension. Pilot trials investigating renal denervation as a potential treatment approach for heart failure were initiated. Heart failure comorbidities like obstructive sleep apnea, metabolic syndrome and arrhythmias could also be targets for renal denervation, because these occurrences are also mediated by the activation of the sympathetic nervous system. Therefore, renal denervation in heart failure is worthy of further investigation, although its effectiveness still has to be proven. Herein, we describe the pathophysiological rationale and the effect of renal denervation on surrogates of the heart failure syndrome. PMID:28154583

An Educator's Guide to the Literature Dealing with the Rationale for Steroid Use, Effects They Have on Body Composition and Performance, with Solutions to Preventing Steroid Abuse in Youth.

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Dawson, Tim R.

This study provides information about steroids and recommends programs to educators and coaches who are involved with educating students about steroid abuse. The first part of the study contains annotations that examine the rationale and motivation of those who have used anabolic steroids. The next part of the study contains annotations that…

Infectious mononucleosis in children: clinical and laboratory rationale and economic efficiency of application of immunocorrectors

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Shvedova N.M.

2013-09-01

Full Text Available Objective: to select the optimal, clinically and economacally effective immunocorrector for the treatment of immune-EBV — mononucleosis in children. Materials: 400 patients with primary Epstein — Barr virus infection aged 1 to 14 years. Results. The therapy by cycloferon of primary Epstein — Barr virus infection observed a statistically significant reduction in the length of stay of patients in hospital, on average, 3 bed-days. Inclusion of cycloferon, viferon in the treatment of infectious mononucleosis, reduces the severity and duration of symptoms of intoxication, the temperature reaction, hepatotoxicity, splenomegaly, lymphoproliferative syndrome. Against the background of cycloferon lower incidence of post-infection anemia was observed. Conclusion. The inclusion of immunocorrectors into therapeutic interventions in primary Epstein — Barr virus infection has been clinically and economically proved.

The Shozu Herpes Zoster (SHEZ) Study: Rationale, Design, and Description of a Prospective Cohort Study

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Takao, Yukiko; Miyazaki, Yoshiyuki; Onishi, Fumitake; Kumihashi, Hideaki; Gomi, Yasuyuki; Ishikawa, Toyokazu; Okuno, Yoshinobu; Mori, Yasuko; Asada, Hideo; Yamanishi, Koichi; Iso, Hiroyasu

2012-01-01

Background The incidence and risk factors for herpes zoster have been studied in cross-sectional and cohort studies, although most such studies have been conducted in Western countries. Evidence from Asian populations is limited, and no cohort study has been conducted in Asia. We are conducting a 3-year prospective cohort study in Shozu County in Kagawa Prefecture, Japan to determine the incidence and predictive and immunologic factors for herpes zoster among Japanese. Methods The participants are followed for 3 years, and a telephone survey is conducted every 4 weeks. The participants were assigned to 1 of 3 studies. Participants in study A gave information on past history of herpes zoster and completed health questionnaires. Study B participants additionally underwent varicella-zoster virus (VZV) skin testing, and study C participants additionally underwent blood testing. If the participants develop herpes zoster, we evaluate clinical symptoms, measure cell-mediated immunity and humoral immunity using venous blood sampling, photograph skin areas with rash, conduct virus identification testing by polymerase chain reaction (PCR) and virus isolation from crust sampling, and evaluate postherpetic pain. Results We recruited 12 522 participants aged 50 years or older in Shozu County from December 2009 through November 2010. The participation rate was 65.7% of the target population. Conclusions The present study is likely to provide valuable data on the incidence and predictive and immunologic factors for herpes zoster in a defined community-based population of Japanese. PMID:22343323

Palifermin for the protection and regeneration of epithelial tissues following injury: new findings in basic research and pre-clinical models.

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Finch, Paul W; Mark Cross, Lawrence J; McAuley, Daniel F; Farrell, Catherine L

2013-09-01

Keratinocyte growth factor (KGF) is a paracrine-acting epithelial mitogen produced by cells of mesenchymal origin, that plays an important role in protecting and repairing epithelial tissues. Pre-clinical data initially demonstrated that a recombinant truncated KGF (palifermin) could reduce gastrointestinal injury and mortality resulting from a variety of toxic exposures. Furthermore, the use of palifermin in patients with hematological malignancies reduced the incidence and duration of severe oral mucositis experienced after intensive chemoradiotherapy. Based upon these findings, as well as the observation that KGF receptors are expressed in many, if not all, epithelial tissues, pre-clinical studies have been conducted to determine the efficacy of palifermin in protecting different epithelial tissues from toxic injury in an attempt to model various clinical situations in which it might prove to be of benefit in limiting tissue damage. In this article, we review these studies to provide the pre-clinical background for clinical trials that are described in the accompanying article and the rationale for additional clinical applications of palifermin. © 2013 The Authors. Journal of Cellular and Molecular Medicine Published by Foundation for Cellular and Molecular Medicine/Blackwell Publishing Ltd.

Age-related macular degeneration in a randomized controlled trial of low-dose aspirin: Rationale and study design of the ASPREE-AMD study

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Liubov Robman

2017-06-01

Conclusion: The study findings will be of significant clinical and public interest due to a potential to identify a possible low cost therapy for preventing AMD worldwide and to determine risk/benefit balance of the aspirin usage by the AMD-affected elderly. The ASPREE-AMD study provides a unique opportunity to determine the effect of aspirin on AMD incidence and progression, by adding retinal imaging to an ongoing, large-scale primary prevention randomized clinical trial.

Efficacy of Internet-Based Guided Treatment for Genito-Pelvic Pain/Penetration Disorder: Rationale, Treatment Protocol, and Design of a Randomized Controlled Trial

OpenAIRE

Zarski, Anna-Carlotta; Berking, Matthias; Ebert, David Daniel

2018-01-01

Introduction Genito-pelvic pain/penetration disorder (GPPPD) not only adversely affects women’s sexuality and sexual satisfaction but is also associated with a wide range of psychosocial consequences such as reduced quality of life and well-being, mental health comorbidities, and relationship distress. Evidence for effective treatment options is scarce. Aim This article describes the rationale, treatment protocol, and study design for a randomized controlled trial examining the efficacy of an...

The target landscape of clinical kinase drugs.

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Klaeger, Susan; Heinzlmeir, Stephanie; Wilhelm, Mathias; Polzer, Harald; Vick, Binje; Koenig, Paul-Albert; Reinecke, Maria; Ruprecht, Benjamin; Petzoldt, Svenja; Meng, Chen; Zecha, Jana; Reiter, Katrin; Qiao, Huichao; Helm, Dominic; Koch, Heiner; Schoof, Melanie; Canevari, Giulia; Casale, Elena; Depaolini, Stefania Re; Feuchtinger, Annette; Wu, Zhixiang; Schmidt, Tobias; Rueckert, Lars; Becker, Wilhelm; Huenges, Jan; Garz, Anne-Kathrin; Gohlke, Bjoern-Oliver; Zolg, Daniel Paul; Kayser, Gian; Vooder, Tonu; Preissner, Robert; Hahne, Hannes; Tõnisson, Neeme; Kramer, Karl; Götze, Katharina; Bassermann, Florian; Schlegl, Judith; Ehrlich, Hans-Christian; Aiche, Stephan; Walch, Axel; Greif, Philipp A; Schneider, Sabine; Felder, Eduard Rudolf; Ruland, Juergen; Médard, Guillaume; Jeremias, Irmela; Spiekermann, Karsten; Kuster, Bernhard

2017-12-01

Kinase inhibitors are important cancer therapeutics. Polypharmacology is commonly observed, requiring thorough target deconvolution to understand drug mechanism of action. Using chemical proteomics, we analyzed the target spectrum of 243 clinically evaluated kinase drugs. The data revealed previously unknown targets for established drugs, offered a perspective on the "druggable" kinome, highlighted (non)kinase off-targets, and suggested potential therapeutic applications. Integration of phosphoproteomic data refined drug-affected pathways, identified response markers, and strengthened rationale for combination treatments. We exemplify translational value by discovering SIK2 (salt-inducible kinase 2) inhibitors that modulate cytokine production in primary cells, by identifying drugs against the lung cancer survival marker MELK (maternal embryonic leucine zipper kinase), and by repurposing cabozantinib to treat FLT3-ITD-positive acute myeloid leukemia. This resource, available via the ProteomicsDB database, should facilitate basic, clinical, and drug discovery research and aid clinical decision-making. Copyright © 2017 The Authors, some rights reserved; exclusive licensee American Association for the Advancement of Science. No claim to original U.S. Government Works.

Critical review of norovirus surrogates in food safety research: rationale for considering volunteer studies.

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Richards, Gary P

2012-03-01

The inability to propagate human norovirus (NoV) or to clearly differentiate infectious from noninfectious virus particles has led to the use of surrogate viruses, like feline calicivirus (FCV) and murine norovirus-1 (MNV), which are propagatable in cell culture. The use of surrogates is predicated on the assumption that they generally mimic the viruses they represent; however, studies are proving this concept invalid. In direct comparisons between FCV and MNV, their susceptibility to temperatures, environmental and food processing conditions, and disinfectants are dramatically different. Differences have also been noted between the inactivation of NoV and its surrogates, thus questioning the validity of surrogates. Considerable research funding is provided globally each year to conduct surrogate studies on NoVs; however, there is little demonstrated benefit derived from these studies in regard to the development of virus inactivation techniques or food processing strategies. Human challenge studies are needed to determine which processing techniques are effective in reducing NoVs in foods. A major obstacle to clinical trials on NoVs is the perception that such trials are too costly and risky, but in reality, there is far more cost and risk in allowing millions of unsuspecting consumers to contract NoV illness each year, when practical interventions are only a few volunteer studies away. A number of clinical trials have been conducted, providing important insights into NoV inactivation. A shift in research priorities from surrogate research to volunteer studies is essential if we are to identify realistic, practical, and scientifically valid processing approaches to improve food safety.

Efficacy of Internet-Based Guided Treatment for Genito-Pelvic Pain/Penetration Disorder: Rationale, Treatment Protocol, and Design of a Randomized Controlled Trial

Directory of Open Access Journals (Sweden)

Anna-Carlotta Zarski

2018-01-01

Full Text Available IntroductionGenito-pelvic pain/penetration disorder (GPPPD not only adversely affects women’s sexuality and sexual satisfaction but is also associated with a wide range of psychosocial consequences such as reduced quality of life and well-being, mental health comorbidities, and relationship distress. Evidence for effective treatment options is scarce.AimThis article describes the rationale, treatment protocol, and study design for a randomized controlled trial examining the efficacy of an Internet-based guided intervention for GPPPD.MethodTwo hundred women who meet the criteria for GPPPD and have not been able to experience sexual intercourse for at least the last 6 months will be recruited and randomly assigned either to the intervention group (IG or a 6-month waitlist control group. Assessments take place at baseline (T1, peritreatment after completion of Session 5 in IG (T2, after completion of Session 8 or 12 weeks after randomization (T3, and after 6 months (T4. Data will be analyzed on an intention-to-treat and a completer basis.Main outcome measuresThe primary outcome will be sexual intercourse involving the insertion of the partner’s penis at posttreatment. Secondary outcomes include, e.g., improved non-intercourse penetration, sexual functioning, dyadic stress coping, reduced fear of sexuality and negative penetration-related cognitions. Fear of sexuality, penetration-related cognitions, and exercise intensity will be assessed as mediators of intercourse in the IG. Sexual dysfunctions of partners will be measured at baseline (T1 and investigated as a potential moderator of the primary treatment outcome.DiscussionGiven the burden associated with GPPPD and the need for specialized treatment, there is a surprising lack of evidence-based treatment options. This study aims to assess whether Internet-based interventions could contribute to closing this treatment gap.Clinical Trial RegistrationGerman Register of Clinical Studies (DRKS

Computer assisted diagnosis in renal nuclear medicine: rationale, methodology and interpretative criteria for diuretic renography

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Taylor, Andrew T; Garcia, Ernest V

2014-01-01

The goal of artificial intelligence, expert systems, decision support systems and computer assisted diagnosis (CAD) in imaging is the development and implementation of software to assist in the detection and evaluation of abnormalities, to alert physicians to cognitive biases, to reduce intra and inter-observer variability and to facilitate the interpretation of studies at a faster rate and with a higher level of accuracy. These developments are needed to meet the challenges resulting from a rapid increase in the volume of diagnostic imaging studies coupled with a concurrent increase in the number and complexity of images in each patient data. The convergence of an expanding knowledge base and escalating time constraints increases the likelihood of physician errors. Errors are even more likely when physicians interpret low volume studies such as 99mTc-MAG3 diuretic scans where imagers may have had limited training or experience. Decision support systems include neural networks, case-based reasoning, expert systems and statistical systems. iRENEX (renal expert) is an expert system for diuretic renography that uses a set of rules obtained from human experts to analyze a knowledge base of both clinical parameters and quantitative parameters derived from the renogram. Initial studies have shown that the interpretations provided by iRENEX are comparable to the interpretations of a panel of experts. iRENEX provides immediate patient specific feedback at the time of scan interpretation, can be queried to provide the reasons for its conclusions and can be used as an educational tool to teach trainees to better interpret renal scans. iRENEX also has the capacity to populate a structured reporting module and generate a clear and concise impression based on the elements contained in the report; adherence to the procedural and data entry components of the structured reporting module assures and documents procedural competency. Finally, although the focus is CAD applied to

The Female Athlete Body (FAB) study: Rationale, design, and baseline characteristics.

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Stewart, Tiffany M; Pollard, Tarryn; Hildebrandt, Tom; Beyl, Robbie; Wesley, Nicole; Kilpela, Lisa Smith; Becker, Carolyn Black

2017-09-01

Eating Disorders (EDs) are serious psychiatric illnesses marked by psychiatric comorbidity, medical complications, and functional impairment. Research indicates that female athletes are often at greater risk for developing ED pathology versus non-athlete females. The Female Athlete Body (FAB) study is a three-site, randomized controlled trial (RCT) designed to assess the efficacy of a behavioral ED prevention program for female collegiate athletes when implemented by community providers. This paper describes the design, intervention, and participant baseline characteristics. Future papers will discuss outcomes. Female collegiate athletes (N=481) aged 17-21 were randomized by site, team, and sport type to either FAB or a waitlist control group. FAB consisted of three sessions (1.3h each) of a behavioral ED prevention program. Assessments were conducted at baseline (pre-intervention), post-intervention (3weeks), and six-, 12-, and 18-month follow-ups. This study achieved 96% (N=481) of target recruitment (N=500). Few group differences emerged at baseline. Total sample analyses revealed moderately low baseline instances of ED symptoms and clinical cases. Health risks associated with EDs necessitate interventions for female athletes. The FAB study is the largest existing RCT for female athletes aimed at both reduction of ED risk factors and ED prevention. The methods presented and population recruited for this study represent an ideal intervention for assessing the effects of FAB on both the aforementioned outcomes. We anticipate that findings of this study (reported in future papers) will make a significant contribution to the ED risk factor reduction and prevention literature. Copyright © 2017 Elsevier Inc. All rights reserved.

Early markers of airways inflammation and occupational asthma: rationale, study design and follow-up rates among bakery, pastry and hairdressing apprentices.

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Tossa, Paul; Bohadana, Abraham; Demange, Valérie; Wild, Pascal; Michaely, Jean-Pierre; Hannhart, Bernard; Paris, Christophe; Zmirou-Navier, Denis

2009-04-23

Occupational asthma is a common type of asthma caused by a specific agent in the workplace. The basic alteration of occupational asthma is airways inflammation. Although most patients with occupational asthma are mature adults, there is evidence that airways inflammation starts soon after inception of exposure, including during apprenticeship. Airways hyper responsiveness to methacholine is a valid surrogate marker of airways inflammation, which has proved useful in occupational epidemiology. But it is time-consuming, requires active subject's cooperation and is not readily feasible. Other non-invasive and potentially more useful tests include the forced oscillation technique, measurement of fraction exhaled nitric oxide, and eosinophils count in nasal lavage fluid. This study aims to investigate early development of airways inflammation and asthma-like symptoms in apprentice bakers, pastry-makers and hairdressers, three populations at risk of occupational asthma whose work-related exposures involve agents of different nature. The objectives are to (i) examine the performance of the non-invasive tests cited above in detecting early airways inflammation that might eventually develop into occupational asthma; and (ii) evaluate whether, and how, constitutional (e.g. atopy) and behavioural (e.g. smoking) risk factors for occupational asthma modulate the effects of allergenic and/or irritative substances involved in these occupations. This paper presents the study rationale and detailed protocol. Among 441 volunteers included at the first visit, 354 attended the fourth one. Drop outs were investigated and showed unrelated to the study outcome. Sample size and follow-up participation rates suggest that the data collected in this study will allow it to meet its objectives.

Rationale and Methodology for a Community-Based Study of Diabetic Retinopathy in an Indonesian Population with Type 2 Diabetes Mellitus: The Jogjakarta Eye Diabetic Study in the Community.

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Sasongko, Muhammad B; Agni, Angela N; Wardhana, Firman S; Kotha, Satya P; Gupta, Prateek; Widayanti, Tri W; Supanji; Widyaputri, Felicia; Widyaningrum, Rifa; Wong, Tien Y; Kawasaki, Ryo; Wang, Jie Jin; Pawiroranu, Suhardjo

2017-02-01

There are no available data about diabetic retinopathy (DR) in the Indonesian population. This report summarizes the rationale and study design of the Jogjakarta Eye Diabetic Study in the Community (JOGED.COM), a community-based study to estimate the prevalence and risk factors of DR in persons with type 2 diabetes in Jogjakarta, Indonesia. The JOGED.COM aimed to examine a cross-sectional sample of 1200 persons with type 2 diabetes aged 30 years and older residing in the study area. We identified 121 community health centers (CHCs) in Jogjakarta and listed 35 CHCs with non-communicable diseases facilities. Multi-stage, clustered random sampling was used to select 22 CHCs randomly. We included CHCs with coverage population >30,000, and excluded those classified as 100% rural. Lists of persons with diabetes confirmed by their family physician were provided from each CHC. Examinations procedures included detailed interviews, general and eye examinations, anthropometry and body composition scan, and dilated fundus photography. We collaborated with local health authorities, family physicians, and local health practitioners in the recruitment phase. A total of 1435 invitations were distributed, and 1184 people (82.5%) with type 2 diabetes participated in this study, of whom 1138 (79.3%) had completed data with gradable retinal images. JOGED.COM is the first epidemiologic study of DR in an Indonesian population. This study will provide key information about the prevalence and risk factors of DR in the community. These data are very important for future health promotion programs to reduce the burden of DR in the population.

Not just another multi-professional course! Part 1. Rationale for a transformative curriculum.

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Duncan, Madeleine; Alperstein, Melanie; Mayers, Pat; Olckers, Lorna; Gibbs, Trevor

2006-02-01

Undergraduate inter- and multi-professional education has traditionally aimed to develop health professionals who are able to collaborate effectively in comprehensive healthcare delivery. The respective professions learn from and about each other through comparisons of roles, responsibilities, powers, duties and perspectives in order to promote integrated service. Described here is the educational rationale of a multi-professional course with a difference; one that injects value to undergraduate health professional education through the development of critical cross-field knowledge, skills and attitudes that unite rather than differentiate professions. The aim of this course, offered at the Faculty of Health Sciences, University of Cape Town, is to lay an integrated, pan-professional foundation for the advancement of collective commitment to and understanding of national health and social development objectives such as primary health care, human rights and professionalism. Pan-professional refers to curriculum content that is core and of critical relevance to all participating professions. What is learned, how it is learned, how learning is facilitated and how it is applied, has been co-constructed by a multi-professional design team representing a range of health professions (audiology, medicine, occupational therapy, nursing, physiotherapy and speech therapy) and academic disciplines (anthropology, sociology, psychology, history, African studies and social development, information technology and language literacy). Education specialists facilitate the ongoing design process ensuring that the structure and content of the curriculum complies with contemporary adult learning principles and national higher education imperatives. Designing the original curriculum required the deconstruction of intra-professional and disciplinary canons of knowledge and ways of 'doing things' in order to identify and develop shared interpretations of critical epistemology and axiology

Korean Clinic Based Outcome Measure Studies

OpenAIRE

Jongbae Park

2003-01-01

Background: Evidence based medicine has become main tools for medical practice. However, conducting a highly ranked in the evidence hierarchy pyramid is not easy or feasible at all times and places. There remains a room for descriptive clinical outcome measure studies with admitting the limit of the intepretation. Aims: Presents three Korean clinic based outcome measure studies with a view to encouraging Korean clinicians to conduct similar studies. Methods: Three studies are presented...

Rationale and design of Mi-CARE: The mile square colorectal cancer screening, awareness and referral and education project.

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Buscemi, Joanna; Miguel, Yazmin San; Tussing-Humphreys, Lisa; Watts, Elizabeth A; Fitzgibbon, Marian L; Watson, Karriem; Winn, Robert A; Matthews, Kameron L; Molina, Yamile

2017-01-01

Although colorectal cancer (CRC) is largely preventable through identification of pre-cancerous polyps through various screening modalities, morbidity and mortality rates remain a challenge, especially in African-American, Latino, low-income and uninsured/underinsured patients. Barriers to screening include cost, access to health care facilities, lack of recommendation to screen, and psychosocial factors such as embarrassment, fear of the test, anxiety about testing preparation and fear of a cancer diagnosis. Various intervention approaches to improve CRC screening rates have been developed. However, comparative effectiveness research (CER) to investigate the relative performance of different approaches has been understudied, especially across different real-life practice settings. Assessment of differential efficacy across diverse vulnerable populations is also lacking. The current paper describes the rationale and design for the Mile Square Colorectal Cancer Screening, Awareness and Referral and Education Project (Mi-CARE), which aims to increase CRC screening rates in 3 clinics of a large Federally Qualified Health Center (FQHC) by reducing prominent barriers to screening for low-income, minority and underserved patients. Patients attending these clinics will receive one of three interventions to increase screening uptake: lay patient navigator (LPN)-based navigation, provider level navigation, or mailed birthday CRC screening reminders. The design of our program allows for comparison of the effectiveness of the tailored interventions across sites and patient populations. Data from Mi-CARE may help to inform the dissemination of tailored interventions across FQHCs to reduce health disparities in CRC. Copyright © 2016 Elsevier Inc. All rights reserved.

Rationale and design of a multicenter randomized clinical trial with memantine and dextromethorphan in ketamine-responder patients.

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Pickering, Gisèle; Pereira, Bruno; Morel, Véronique; Tiberghien, Florence; Martin, Elodie; Marcaillou, Fabienne; Picard, Pascale; Delage, Noémie; de Montgazon, Géraldine; Sorel, Marc; Roux, Delphine; Dubray, Claude

2014-07-01

The N-methyl-D-aspartate receptor plays an important role in central sensitization of neuropathic pain and N-methyl-D-aspartate receptor antagonists, such as ketamine, memantine and dextromethorphan may be used for persistent pain. However, ketamine cannot be repeated too often because of its adverse events. A drug relay would be helpful in the outpatient to postpone or even cancel the next ketamine infusion. This clinical trial evaluates if memantine and/or dextromethorphan given as a relay to ketamine responders may maintain or induce a decrease of pain intensity and have a beneficial impact on cognition and quality of life. This trial is a multi-center, randomized, controlled and single-blind clinical study (NCT01602185). It includes 60 ketamine responder patients suffering from neuropathic pain. They are randomly allocated to memantine, dextromethorphan or placebo. After ketamine infusion, 60 patients received either memantine (maximal dose 20 mg/day), or dextromethorphan (maximal dose 90 mg/day), or placebo for 12 weeks. The primary endpoint is pain measured on a (0-10) Numeric Rating Scale 1 month after inclusion. Secondary outcomes include assessment of neuropathic pain, sleep, quality of life, anxiety/depression and cognitive function at 2 and 3 months. Data analysis is performed using mixed models and the tests are two-sided, with a type I error set at α=0.05. This study will explore if oral memantine and/or dextromethorphan may be a beneficial relay in ketamine responders and may diminish ketamine infusion frequency. Preservation of cognitive function and quality of life is also a central issue that will be analyzed in these vulnerable patients. Copyright © 2014. Published by Elsevier Inc.

Efficacy of Internet-Based Guided Treatment for Genito-Pelvic Pain/Penetration Disorder: Rationale, Treatment Protocol, and Design of a Randomized Controlled Trial

OpenAIRE

Anna-Carlotta Zarski; Anna-Carlotta Zarski; Matthias Berking; David Daniel Ebert

2018-01-01

IntroductionGenito-pelvic pain/penetration disorder (GPPPD) not only adversely affects women’s sexuality and sexual satisfaction but is also associated with a wide range of psychosocial consequences such as reduced quality of life and well-being, mental health comorbidities, and relationship distress. Evidence for effective treatment options is scarce.AimThis article describes the rationale, treatment protocol, and study design for a randomized controlled trial examining the efficacy of an In...

Clinical EPR: Unique Opportunities and Some Challenges

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Swartz, Harold M.; Williams, Benjamin B.; Zaki, Bassem I.; Hartford, Alan C.; Jarvis, Lesley A.; Chen, Eunice; Comi, Richard J.; Ernstoff, Marc S.; Hou, Huagang; Khan, Nadeem; Swarts, Steven G.; Flood, Ann B.; Kuppusamy, Periannan

2014-01-01

Electron paramagnetic resonance (EPR) spectroscopy has been well established as a viable technique for measurement of free radicals and oxygen in biological systems, from in vitro cellular systems to in vivo small animal models of disease. However, the use of EPR in human subjects in the clinical setting, although attractive for a variety of important applications such as oxygen measurement, is challenged with several factors including the need for instrumentation customized for human subjects, probe and regulatory constraints. This paper describes the rationale and development of the first clinical EPR systems for two important clinical applications, namely, measurement of tissue oxygen (oximetry), and radiation dose (dosimetry) in humans. The clinical spectrometers operate at 1.2 GHz frequency and use surface loop resonators capable of providing topical measurements up to 1 cm depth in tissues. Tissue pO2 measurements can be carried out noninvasively and repeatedly after placement of an oxygen-sensitive paramagnetic material (currently India ink) at the site of interest. Our EPR dosimetry system is capable of measuring radiation-induced free radicals in the tooth of irradiated human subjects to determine the exposure dose. These developments offer potential opportunities for clinical dosimetry and oximetry, which include guiding therapy for individual patients with tumors or vascular disease, by monitoring of tissue oxygenation. Further work is in progress to translate this unique technology to routine clinical practice. PMID:24439333

Tuberculous meningitis: a uniform case definition for use in clinical research.

Science.gov (United States)

Marais, Suzaan; Thwaites, Guy; Schoeman, Johan F; Török, M Estée; Misra, Usha K; Prasad, Kameshwar; Donald, Peter R; Wilkinson, Robert J; Marais, Ben J

2010-11-01

Tuberculous meningitis causes substantial mortality and morbidity in children and adults. More research is urgently needed to better understand the pathogenesis of disease and to improve its clinical management and outcome. A major stumbling block is the absence of standardised diagnostic criteria. The different case definitions used in various studies makes comparison of research findings difficult, prevents the best use of existing data, and limits the management of disease. To address this problem, a 3-day tuberculous meningitis workshop took place in Cape Town, South Africa, and was attended by 41 international participants experienced in the research or management of tuberculous meningitis. During the meeting, diagnostic criteria were assessed and discussed, after which a writing committee was appointed to finalise a consensus case definition for tuberculous meningitis for use in future clinical research. We present the consensus case definition together with the rationale behind the recommendations. This case definition is applicable irrespective of the patient's age, HIV infection status, or the resources available in the research setting. Consistent use of the proposed case definition will aid comparison of studies, improve scientific communication, and ultimately improve care. Copyright © 2010 Elsevier Ltd. All rights reserved.

A community-based obesity prevention program for minority children: rationale and study design for Hip-Hop to Health Jr.

Science.gov (United States)

Fitzgibbon, Marian L; Stolley, Melinda R; Dyer, Alan R; VanHorn, Linda; KauferChristoffel, Katherine

2002-02-01

BACKGROUND; The increasing prevalence of overweight among children in the United States presents a national health priority. Higher rates of overweight/obesity among minority women place their children at increased risk. Although increased rates of overweight are observed in 4- to 5-year-old children, they are not observed in 2- to 3-year-old children. Therefore, early prevention efforts incorporating families are critical. The primary aim of Hip-Hop to Health Jr. is to alter the trajectory toward overweight/obesity among preschool African-American and Latino children. This 5-year randomized intervention is conducted in 24 Head Start programs, where each site is randomized to either a 14-week dietary/physical activity intervention or a general health intervention. This paper presents the rationale and design of the study. Efficacy of the intervention will be determined by weight change for the children and parent/caretaker. Secondary measures include reductions in dietary fat and increases in fiber, fruit/vegetable intake, and physical activity. Baseline data will be presented in future papers. The problem of overweight/obesity is epidemic in the United States. Behaviors related to diet and physical activity are established early in life and modeled by family members. Early intervention efforts addressing the child and family are needed to prevent obesity later in life. This paper describes a comprehensive, family-oriented obesity prevention program for minority preschool children. Copyright 2002 American Health Foundation and Elsevier Science (USA).

College of American Pathologists Gynecologic Cytopathology Quality Consensus Conference on good laboratory practices in gynecologic cytology: background, rationale, and organization.

Science.gov (United States)

Tworek, Joseph A; Henry, Michael R; Blond, Barbara; Jones, Bruce Allen

2013-02-01

Gynecologic cytopathology is a heavily regulated field, with Clinical Laboratory Improvement Amendments of 1988 mandating the collection of many quality metrics. There is a lack of consensus regarding methods to collect, monitor, and benchmark these data and how these data should be used in a quality assurance program. Furthermore, the introduction of human papilloma virus testing and proficiency testing has provided more data to monitor. To determine good laboratory practices in quality assurance of gynecologic cytopathology. Data were collected through a written survey consisting of 98 questions submitted to 1245 Clinical Laboratory Improvement Amendments-licensed or Department of Defense laboratories. There were 541 usable responses. Additional input was sought through a Web posting of results and questions on the College of American Pathologists Web site. Four senior authors who authored the survey and 28 cytopathologists and cytotechnologists were assigned to 5 working groups to analyze data and present statements on good laboratory practices in gynecologic cytopathology at the College of American Pathologists Gynecologic Cytopathology Quality Consensus Conference. Ninety-eight attendees at the College of American Pathologists Gynecologic Cytopathology Quality Consensus Conference discussed and voted on good laboratory practice statements to obtain consensus. This paper describes the rationale, background, process, and strengths and limitations of a series of papers that summarize good laboratory practice statements in quality assurance in gynecologic cytopathology.

Organizing the public health-clinical health interface: theoretical bases.

Science.gov (United States)

St-Pierre, Michèle; Reinharz, Daniel; Gauthier, Jacques-Bernard

2006-01-01

This article addresses the issue of the interface between public health and clinical health within the context of the search for networking approaches geared to a more integrated delivery of health services. The articulation of an operative interface is complicated by the fact that the definition of networking modalities involves complex intra- and interdisciplinary and intra- and interorganizational systems across which a new transversal dynamics of intervention practices and exchanges between service structures must be established. A better understanding of the situation is reached by shedding light on the rationale underlying the organizational methods that form the bases of the interface between these two sectors of activity. The Quebec experience demonstrates that neither the structural-functionalist approach, which emphasizes remodelling establishment structures and functions as determinants of integration, nor the structural-constructivist approach, which prioritizes distinct fields of practice in public health and clinical health, adequately serves the purpose of networking and integration. Consequently, a theoretical reframing is imperative. In this regard, structuration theory, which fosters the simultaneous study of methods of inter-structure coordination and inter-actor cooperation, paves the way for a better understanding of the situation and, in turn, to the emergence of new integration possibilities.

Enhancing measurement in science education research through Rasch analysis: Rationale and properties

Directory of Open Access Journals (Sweden)

Jørgen Sjaastad

2014-10-01

Full Text Available This article presents the basic rationale of Rasch theory and seven core properties of Rasch modeling; analyses of test targeting, person separation, person fit, item fit, differential item functioning, functioning of response categories and tests of unidimensionality. Illustrative examples are provided consecutively, drawing on Rasch analysis of data from a survey where students in the 9th grade responded to questions regarding their mathematics competence. The relationship between Rasch theory and classical test theory is commented on. Rasch theory provides science and mathematics education researchers with valuable tools to evaluate the psychometric quality of tests and questionnaires and support the development of these.

Radiotherapy for pediatric brain tumors: Standard of care, current clinical trials and new directions

International Nuclear Information System (INIS)

Kun, Larry E.

1997-01-01

chemotherapeutic components of therapy. The outcome of supratentorial malignant gliomas and diffusely infiltrating pontine gliomas remains poor; data from recent studies will be presented to highlight current therapy and investigational approaches. The impact of tumor extent and resectability in ependymoma and craniopharyngioma will be reviewed to emphasize current practice, clinical investigations, and debate regarding the indications for radiation therapy and introduction of 3-D techniques. The rationale for recommended radiation volume(s) for intracranial germinomas will be reviewed, as well as recent data addressing combined chemoradiation for CNS germ cell tumors. Recognizing the unique risk:benefit ratio in treating infants and young children with malignant brain tumors, the indications for radiation therapy, timing, and potential modifications of therapy will be highlighted

The pharmacological rationale for combining muscarinic receptor antagonists and beta-adrenoceptor agonists in the treatment of airway and bladder disease

NARCIS (Netherlands)

Dale, Philippa R.; Cernecka, Hana; Schmidt, Martina; Dowling, Mark R.; Charlton, Steven J.; Pieper, Michael P.; Michel, Martin C.

Muscarinic receptor antagonists and beta-adrenoceptor agonists are used in the treatment of obstructive airway disease and overactive bladder syndrome. Here we review the pharmacological rationale for their combination. Muscarinic receptors and beta-adrenoceptors are physiological antagonists for

BALANOPOSTHITIS: A CLINICAL STUDY

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Raju

2015-01-01

Full Text Available INTRODUCTION: The inflammation of the non - keratinized epithelium of the glans penis (i.e., Balanities and that of prepuce (i.e., posthitis together comprise the term Balanoposthitis. AIMS AND OBJECTIVES: To determine the aetiological and p redisposing factors for the development of Balanoposthitis, and to know its relation with venereal and non - venereal disease, local and systemic precipitatin g factors. To know the prevalence of Balanoposthitis in STD clinic. Study design - retrospective study . MATERIALS AND METHODS: The study material consists of 75 cases of balanoposthitis attending out - patient department Skin & STD clinic during a period exten din g from Feb, 1998 to Feb, 1999 . CRITERIA FOR SELECTION OF A CASE: Only those cases which have a history of redness of glans or mucous surface of prepuce, with or without genital discharge or ulcer on glans or mucosal surface of prepuce with or without discharge or growth on the penis or fissuring of fore skin were selected for the study. RESULTS: Incidence of balanoposthitis during the period from Feb. 98 to Feb.99 was – 11.53%, out of 650 new STD cases. It was observed that maximum number of pat i ents w as in the 21 - 30 age group (33.34%. The next predominant groups affected were 17 - 20 & 31 - 40 age group (20% each. The third most common age group affected was 41 - 50 (16%. In this study 69 patients (92% who presented with balanoposthitis of whatever cause were found to be uncircumcised, only 6 cases (8% were found to be circumcised. Most cases who presented with balanoposthitis gave a history of exposure to STD risk. CONCLUSIONS: Balanoposthitis is very commonly encountered condition in the STD clinics wi th a multi factorial aetiology. Infective causes dominated over the other possible causes, and 30% of the candidial infection had diabetes mellitus as a predisposing factor.

Early markers of airways inflammation and occupational asthma: Rationale, study design and follow-up rates among bakery, pastry and hairdressing apprentices

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Hannhart Bernard

2009-04-01

Full Text Available Abstract Background Occupational asthma is a common type of asthma caused by a specific agent in the workplace. The basic alteration of occupational asthma is airways inflammation. Although most patients with occupational asthma are mature adults, there is evidence that airways inflammation starts soon after inception of exposure, including during apprenticeship. Airways hyper responsiveness to methacholine is a valid surrogate marker of airways inflammation, which has proved useful in occupational epidemiology. But it is time-consuming, requires active subject's cooperation and is not readily feasible. Other non-invasive and potentially more useful tests include the forced oscillation technique, measurement of fraction exhaled nitric oxide, and eosinophils count in nasal lavage fluid. Methods and design This study aims to investigate early development of airways inflammation and asthma-like symptoms in apprentice bakers, pastry-makers and hairdressers, three populations at risk of occupational asthma whose work-related exposures involve agents of different nature. The objectives are to (i examine the performance of the non-invasive tests cited above in detecting early airways inflammation that might eventually develop into occupational asthma; and (ii evaluate whether, and how, constitutional (e.g. atopy and behavioural (e.g. smoking risk factors for occupational asthma modulate the effects of allergenic and/or irritative substances involved in these occupations. This paper presents the study rationale and detailed protocol. Discussion Among 441 volunteers included at the first visit, 354 attended the fourth one. Drop outs were investigated and showed unrelated to the study outcome. Sample size and follow-up participation rates suggest that the data collected in this study will allow it to meet its objectives.

Using social media to deliver weight loss programming to young adults: Design and rationale for the Healthy Body Healthy U (HBHU) trial.

Science.gov (United States)

Napolitano, Melissa A; Whiteley, Jessica A; Mavredes, Meghan N; Faro, Jamie; DiPietro, Loretta; Hayman, Laura L; Neighbors, Charles J; Simmens, Samuel

2017-09-01

The transitional period from late adolescence to early adulthood is a vulnerable period for weight gain, with a twofold increase in overweight/obesity during this life transition. In the United States, approximately one-third of young adults have obesity and are at a high risk for weight gain. To describe the design and rationale of a National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) sponsored randomized, controlled clinical trial, the Healthy Body Healthy U (HBHU) study, which compares the differential efficacy of three interventions on weight loss among young adults aged 18-35years. The intervention is delivered via Facebook and SMS Text Messaging (text messaging) and includes: 1) targeted content (Targeted); 2) tailored or personalized feedback (Tailored); or 3) contact control (Control). Recruitment is on-going at two campus sites, with the intervention delivery conducted by the parent site. A total of 450 students will be randomly-assigned to receive one of three programs for 18months. We hypothesize that: a) the Tailored group will lose significantly more weight at the 6, 12, 18month follow-ups compared with the Targeted group; and that b) both the Tailored and Targeted groups will have greater weight loss at the 6, 12, 18month follow-ups than the Control group. We also hypothesize that participants who achieve a 5% weight loss at 6 and 18months will have greater improvements in their cardiometabolic risk factors than those who do not achieve this target. We will examine intervention costs to inform implementation and sustainability other universities. Expected study completion date is 2019. This project has significant public health impact, as the successful translation could reach as many as 20 million university students each year, and change the current standard of practice for promoting weight management within university campus communities. ClinicalTrial.gov: NCT02342912. Copyright © 2017. Published by Elsevier Inc.

Potential Impact on Clinical Decision Making via a Genome-Wide Expression Profiling: A Case Report

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Hyun Kim

2016-11-01

Full Text Available Management of men with prostate cancer is fraught with uncertainty as physicians and patients balance efficacy with potential toxicity and diminished quality of life. Utilization of genomics as a prognostic biomarker has improved the informed decision-making process by enabling more rationale treatment choices. Recently investigations have begun to determine whether genomic information from tumor transcriptome data can be used to impact clinical decision-making beyond prognosis. Here we discuss the potential of genomics to alter management of a patient who presented with high-risk prostate adenocarcinoma. We suggest that this information help selecting patients for advanced imaging, chemotherapies, or clinical trial.

Campath, calcineurin inhibitor reduction and chronic allograft nephropathy (3C) study: background, rationale, and study protocol

Science.gov (United States)

2013-01-01

Background Kidney transplantation is the best treatment for patients with end-stage renal failure, but uncertainty remains about the best immunosuppression strategy. Long-term graft survival has not improved substantially, and one possible explanation is calcineurin inhibitor (CNI) nephrotoxicity. CNI exposure could be minimized by using more potent induction therapy or alternative maintenance therapy to remove CNIs completely. However, the safety and efficacy of such strategies are unknown. Methods/Design The Campath, Calcineurin inhibitor reduction and Chronic allograft nephropathy (3C) Study is a multicentre, open-label, randomized controlled trial with 852 participants which is addressing two important questions in kidney transplantation. The first question is whether a Campath (alemtuzumab)-based induction therapy strategy is superior to basiliximab-based therapy, and the second is whether, from 6 months after transplantation, a sirolimus-based maintenance therapy strategy is superior to tacrolimus-based therapy. Recruitment is complete, and follow-up will continue for around 5 years post-transplant. The primary endpoint for the induction therapy comparison is biopsy-proven acute rejection by 6 months, and the primary endpoint for the maintenance therapy comparison is change in estimated glomerular filtration rate from baseline to 2 years after transplantation. The study is sponsored by the University of Oxford and endorsed by the British Transplantation Society, and 18 centers for adult kidney transplant are participating. Discussion Late graft failure is a major issue for kidney-transplant recipients. If our hypothesis that minimizing CNI exposure with Campath-based induction therapy and/or an elective conversion to sirolimus-based maintenance therapy can improve long-term graft function and survival is correct, then patients should experience better graft function for longer. A positive outcome could change clinical practice in kidney transplantation. Trial

Troublesome Construction: The Rationale and Risks of IIRSA

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Pitou van Dijck

2008-10-01

Full Text Available Latin American countries are involved in implementing a continental-wide infrastructure programme to deepen regional integration and facilitate their insertion in international markets. The IIRSA [Iniciativa para la Integración de la Infraestructura Regional Suramericana] program- me includes ten so called development hubs that may contribute to significant change in the location of economic activities in the continent as well. They may as well have a substantial impact on the environment in regions adjacent to the corridors. This study deals with the rationale and organization of the IIRSA infrastructure programme. Subsequently the study focuses on the spatial impact such corridors may have and the environmental, social and economic implication of these roads. Finally the paper deals with some critical methodological problems involved in the making of of strategic environmental assessment studies of IIRSA-related road infrastructure projects.  Resumen: Una construcción problemática: Razones y riesgos de IIRSALos países latinoamericanos están implementando un programa continental de infraestructura para profundizar la integración regional y facilitar su inserción en los mercados internacionales. El programa de IIRSA [Iniciativa para la Integración de la Infraestructura Regional Surameri cana] incluye diez centros de desarrollo que pueden contribuir a cambios importantes en la ubicación de las actividades económicas en el continente. Estos centros podrían tener un impacto substancial en el medioambiente de las regiones adyacentes a los corredores. Este estudio se ocupa de las razones y organización del programa de infraestructura de IIRSA. Luego nos concentramos en el impacto espacial que pueden tener esos corredores y las implicaciones sociales, económicas y para el medioambiente de esos caminos. Finalmente tratamos en el artículo algunos críticos problemas metodológicos en la elaboración de evaluaciones medioambientales

Implementing Attachment and Biobehavioral Catch-Up with birth parents: Rationale and case example.

Science.gov (United States)

Hoye, Julie R; Dozier, Mary

2018-05-25

Attachment and Biobehavioral Catch-Up (ABC) is an intervention designed for vulnerable children and their parents. This intervention enhances parental sensitivity and nurturance with the goal of promoting secure, organized attachments and strong self-regulatory capabilities among children. Here, we provide a brief rationale for the need for such interventions to be delivered to parent-child dyads in the child welfare system. Next, we review specific intervention targets of ABC. We include a case example of two birth parents and their daughter who became involved in Child Protective Services due to domestic violence. © 2018 Wiley Periodicals, Inc.

FUNCTIONAL STUDIES ON BLOOD MICROCIRCULATION SYSTEM WITH LASER DOPPLER FLOWMETRY IN CLINICAL MEDICINE: PROBLEMS AND PROSPECTS

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D. G. Lapitan

2016-01-01

Full Text Available The paper presents a  review of the research update on the blood microcirculation system assessed with laser Doppler flowmetry (LDF. Specific procedures for measurement of the microcirculation index by LDF and individual variability of microcirculation parameters during their real time assessment in vivo are discussed. In physiological conditions, a relative deviation of the results of measurements by LDF is within the range±35% and above from the mean value of the microcirculation index. This imposes certain limitations on the interpretation of the diagnostic results in terms of the “normal or pathologic”. Specifics of performance of functional stress tests on the microcirculation system are reviewed. Diagnostic criteria based on functional stress testing of the microcirculation system, which can be implemented with methodologically strict normatives and regulations, for examples, those for the occlusion test, are more reliable from metrologic perspective and significant compared to the results obtained without stress testing. Problems of implementation of the functional tests into clinical practice are discussed. It was shown that they may have a potentially wide spectrum of clinical indications, from functional diagnostics and early detection of microcirculatory abnormalities in diabetes mellitus, arterial hypertension and other diseases associated with microcirculatory disorders, to the physical rationale of exposure parameters, as well as objectification of efficiency of medical procedures aimed to stimulation of the microcirculatory functions in a patient's tissues and organs.

An evaluation of flora from coastal sand dunes of India: Rationale for conservation and management

Digital Repository Service at National Institute of Oceanography (India)

Rodrigues, R.S.; Mascarenhas, A.; Jagtap, T.G.

stream_size 37100 stream_content_type text/plain stream_name Ocean_Coast_Manage_54_181a.pdf.txt stream_source_info Ocean_Coast_Manage_54_181a.pdf.txt Content-Encoding UTF-8 Content-Type text/plain; charset=UTF-8 1... Author version: Ocean & Coastal Management, vol.54(2); 2011; 181-188 An evaluation of flora from coastal sand dunes of India: Rationale for conservation and management Rouchelle S. Rodrigues, Antonio Mascarenhas, Tanaji G. Jagtap * National...

The ExStroke Pilot Trial: rationale, design, and baseline data of a randomized multicenter trial comparing physical training versus usual care after an ischemic stroke

DEFF Research Database (Denmark)

Krarup, L.H.; Gluud, C.; Truelsen, T.

2008-01-01

of increasing stroke patients' level of physical activity and secondarily to associate the level of physical activity to the risk of recurrent stroke, myocardial infarction, and all-cause mortality in the two groups. We describe the rationale, design, and baseline data of the ExStroke Pilot Trial. METHODS......INTRODUCTION: A high level of physical activity is associated with a decreased risk of first stroke and physical activity modifies recognized stroke risk factors and is recommended for stroke survivors. Available research shows that stroke patients can increase their level of physical performance...... over a short period. When the intervention period is over, physical performance often declines towards baseline level. Currently, there is no evidence on the association between physical activity and the risk of recurrent stroke. The ExStroke Pilot Trial is a randomized clinical trial with the aim...

A clinical plan for MDMA (Ecstasy) in the treatment of posttraumatic stress disorder (PTSD): partnering with the FDA.

Science.gov (United States)

Doblin, Rick

2002-01-01

The FDA and the Spanish Ministry of Health have concluded that the risk/benefit ratio is favorable under certain circumstances for clinical studies investigating MDMA-assisted psychotherapy. Both agencies have approved pilot studies in chronic posttraumatic stress disorder (PTSD) patients who have failed to obtain relief from at least one course of conventional treatment. These studies, the only ones in the world into the therapeutic use of MDMA, are being funded by a nonprofit research and educational organization, the Multidisciplinary Association for Psychedelic Studies (MAPS, www.maps.org). A rationale is offered explaining why MAPS chose to focus its limited resources on MDMA, and also on PTSD patients. A Clinical Plan is elaborated for the conduct of the "adequate and well-controlled" trials necessary to evaluate the safety and efficacy of MDMA-assisted psychotherapy for PTSD, with the studies estimated to cost about 5 million dollars and to take about five years. The Clinical Plan has been developed, in part, through analysis of the studies conducted by Pfizer in its successful effort to have Zoloft approved by the FDA for use with PTSD patients, and through review of transcripts of the FDA's Psychopharmacologic Drugs Advisory Committee meeting that recommended approval of Zoloft for PTSD.

Clinical education and clinical evaluation of respiratory therapy students.

Science.gov (United States)

Cullen, Deborah L

2005-09-01

Different blends of knowledge, decision making, problem solving,professional behaviors, values, and technical skills are necessary in the changing health care environments in which respiratory therapists practice. Frequently, novice students are expected to perform quickly and efficiently,and it may be forgotten that students are still learning and mastering the foundation pieces of practice. Clinical educators take on the responsibility of student development in addition to overseeing patient care. Normally,these volunteer instructors are role models for respiratory therapy students. The characteristic of initiative when demonstrated by a beginning student is attractive to the clinical instructor, promotes sharing of experiences, and may evolve into a mentor-protege relationship. Some clinical instructors may be underprepared to teach and are uncomfortable with student evaluation. Respiratory therapy facilities in conjunction with academic institutions may consider sponsoring ongoing programs for clinical teachers. Teaching and learning in the clinical environment is more than demonstration of skills and knowledge. Furthermore, it can be debated whether the memorization of facts or of the steps of a skill is more valuable than competency in problem solving, clinical reasoning, or information retrieval. New knowledge is built within a context and is further integrated when grounded by experience. Development of "prediction in practice" or the anticipation of the next necessary actions may be worth integrating into the instructional toolbox. Intuition has been defined as an "understanding without a rationale". This definition separates intuition from rational decision making and presents intuition as a type of innate ability. Reflection when guided by clinical instructors can help deepen critical thinking, as will Socratic questioning on a regular basis. Most clinical staff can agree on the performance of an incompetent student, but discrimination of the levels of

Combining Upper Limb Robotic Rehabilitation with Other Therapeutic Approaches after Stroke: Current Status, Rationale, and Challenges

Directory of Open Access Journals (Sweden)

Stefano Mazzoleni

2017-01-01

Full Text Available A better understanding of the neural substrates that underlie motor recovery after stroke has led to the development of innovative rehabilitation strategies and tools that incorporate key elements of motor skill relearning, that is, intensive motor training involving goal-oriented repeated movements. Robotic devices for the upper limb are increasingly used in rehabilitation. Studies have demonstrated the effectiveness of these devices in reducing motor impairments, but less so for the improvement of upper limb function. Other studies have begun to investigate the benefits of combined approaches that target muscle function (functional electrical stimulation and botulinum toxin injections, modulate neural activity (noninvasive brain stimulation, and enhance motivation (virtual reality in an attempt to potentialize the benefits of robot-mediated training. The aim of this paper is to overview the current status of such combined treatments and to analyze the rationale behind them.

Design and rationale of the Procalcitonin Antibiotic Consensus Trial (ProACT), a multicenter randomized trial of procalcitonin antibiotic guidance in lower respiratory tract infection.

Science.gov (United States)

Huang, David T; Angus, Derek C; Chang, Chung-Chou H; Doi, Yohei; Fine, Michael J; Kellum, John A; Peck-Palmer, Octavia M; Pike, Francis; Weissfeld, Lisa A; Yabes, Jonathan; Yealy, Donald M

2017-08-29

Overuse of antibiotics is a major public health problem, contributing to growing antibiotic resistance. Procalcitonin has been reported to be commonly elevated in bacterial, but not viral infection. Multiple European trials found procalcitonin-guided care reduced antibiotic use in lower respiratory tract infection, with no apparent harm. However, applicability to US practice is limited due to trial design features impractical in the US, between-country differences, and residual safety concerns. The Procalcitonin Antibiotic Consensus Trial (ProACT) is a multicenter randomized trial to determine the impact of a procalcitonin antibiotic prescribing guideline, implemented with basic reproducible strategies, in US patients with lower respiratory tract infection. We describe the trial methods using the Consolidated Standards of Reporting Trials (CONSORT) framework, and the rationale for key design decisions, including choice of eligibility criteria, choice of control arm, and approach to guideline implementation. ClinicalTrials.gov NCT02130986 . Registered May 1, 2014.

Prospective Clinical Testing of Regulatory Dendritic Cells in Organ Transplantation.

Science.gov (United States)

Thomson, Angus W; Zahorchak, Alan F; Ezzelarab, Mohamed B; Butterfield, Lisa H; Lakkis, Fadi G; Metes, Diana M

2016-01-01

Dendritic cells (DC) are rare, professional antigen-presenting cells with ability to induce or regulate alloimmune responses. Regulatory DC (DCreg) with potential to down-modulate acute and chronic inflammatory conditions that occur in organ transplantation can be generated in vitro under a variety of conditions. Here, we provide a rationale for evaluation of DCreg therapy in clinical organ transplantation with the goal of promoting sustained, donor-specific hyporesponsiveness, while lowering the incidence and severity of rejection and reducing patients' dependence on anti-rejection drugs. Generation of donor- or recipient-derived DCreg that suppress T cell responses and prolong transplant survival in rodents or non-human primates has been well-described. Recently, good manufacturing practice (GMP)-grade DCreg have been produced at our Institution for prospective use in human organ transplantation. We briefly review experience of regulatory immune therapy in organ transplantation and describe our experience generating and characterizing human monocyte-derived DCreg. We propose a phase I/II safety study in which the influence of donor-derived DCreg combined with conventional immunosuppression on subclinical and clinical rejection and host alloimmune responses will be examined in detail.

Rationale for Using Social Media to Collect Patient-Reported Outcomes in Patients with Celiac Disease.

Science.gov (United States)

Park, Kt; Harris, Merissa; Khavari, Nasim; Khosla, Chaitan

2014-02-01

Patients with celiac disease (CD) are increasingly interconnected through social media, exchanging patient experiences and health-tracking information between individuals through various web-based platforms. Social media represents potentially unique communication interface between gastroenterologists and active social media users - especially young adults and adolescents with celiac disease-regarding adherence to the strict gluten-free diet, gastrointestinal symptoms, and meaningful discussion about disease management. Yet, various social media platforms may be underutilized for research purposes to collect patient-reported outcomes data. In this commentary, we summarize the scientific rationale and potential for future growth of social media in patient-reported outcomes research, focusing on college freshmen with celiac disease as a case study and provide overview of the methodological approach. Finally, we discuss how social media may impact patient care in the future through increasing mobile technology use.

Barriers for guideline adherence in knee osteoarthritis care: A qualitative study from the patients' perspective

NARCIS (Netherlands)

Spitaels, D.; Vankrunkelsven, P.; Desfosses, J.; Luyten, F.; Verschueren, S.; Assche, D. Van; Aertgeerts, B.; Hermens, R.P.

2017-01-01

RATIONALE, AIMS AND OBJECTIVES: Guidelines for patients with knee osteoarthritis (OA) are suboptimally implemented in clinical care. To improve guideline adherence, patients' perceived barriers and facilitators in current care were investigated. METHODS: Eleven patients with knee OA were extensively

Considerations for Clinical Neuropsychological Evaluation in Amyotrophic Lateral Sclerosis.

Science.gov (United States)

Woolley, Susan C; Rush, Beth K

2017-11-01

The clinical neuropsychologist has the opportunity to be uniquely involved in the evaluation and treatment of individuals with amyotrophic lateral sclerosis (ALS). We review the current literature that defines cognitive and behavioral symptoms in ALS, including current knowledge of the neuropathological and genetic underpinning for these symptoms. There are unique considerations for clinical neuropsychological evaluation and clinical research in ALS and we highlight these in this review. Specifically, we shed light on special factors that contribute to our understanding of cognitive and behavioral impairment in ALS, including co-morbid symptoms, differential diagnosis, and considerations for longitudinal tracking of phenotypes. We discuss the rationale for proposing a specific approach to such as cognitive screening, test selection, response modality consideration, and test-retest intervals. With this didactic overview, the clinical neuropsychologist has the potential to learn more about the heterogeneous presentation of motor and neuropsychological symptoms in ALS. Furthermore, the reader has the opportunity to understand what it takes to develop a valid assessment approach particularly when the phenotype of ALS remains undefined in some regards. This clinical practice review sets the stage for the clinical neuropsychologist to further contribute to our clinical and scientific understanding of ALS and cognition. © The Author 2017. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Design, rationale, and baseline demographics of SEARCH I: a prospective cluster-randomized study

Directory of Open Access Journals (Sweden)

Albers F

2012-07-01

Full Text Available Frank Albers,1 Asif Shaikh,2 Ahmar Iqbal,31Medical Affairs Respiratory, 2Clinical Development and Medical Affairs, Field Based Medicine-Respiratory, Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, CT, USA; 3Respiratory Medical Affairs, Pfizer Inc, New York, NY, USAAbstract: Questionnaires are available to identify patients at risk for several chronic diseases, including COPD, but are infrequently utilized in primary care. COPD is often underdiagnosed, while at the same time the US Preventive Services Task Force recommends against spirometric screening for COPD in asymptomatic adults. Use of a symptom-based questionnaire and subsequent handheld spirometric device depending on the answers to the questionnaire is a promising approach to identify patients at risk for COPD. Screening, Evaluating and Assessing Rate CHanges of diagnosing respiratory conditions in primary care 1 (SEARCH I was a prospective cluster-randomized study in 168 US primary care practices evaluating the effect of the COPD-Population Screener (COPD-PS™ questionnaire. The effect of this questionnaire alone or sequentially with the handheld copd-6TM device was evaluated on new diagnoses of COPD and on respiratory diagnostic practice patterns (including referrals for pulmonary function testing, referrals to pulmonologists, new diagnoses of COPD, and new respiratory medication prescriptions. Participating practices entered a total of 9704 consecutive consenting subjects aged ≥ 40 years attending primary care clinics. Study arm results were compared for new COPD diagnosis rates between usual care and (1 COPD-PS plus copd-6 and (2 COPD-PS alone. A cluster-randomization design allowed comparison of the intervention effects at the practice level instead of individuals being the subjects of the intervention. Regional principal investigators controlled the flow of study information to sub-investigators at participating practices to reduce observation bias (Hawthorne effect. The

Small sustainable monetary incentives versus charitable donations to promote exercise: Rationale, design, and baseline data from a randomized pilot study.

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Williams, David M; Lee, Harold H; Connell, Lauren; Boyle, Holly; Emerson, Jessica; Strohacker, Kelley; Galárraga, Omar

2018-03-01

Regular physical activity (PA) enhances weight-loss and reduces risk of chronic disease. However, as few as 10% of U.S. adults engage in regular PA. Incentive programs to promote PA have shown some promise, but have typically used incentives that are too large to sustain over time and have not demonstrated habit formation or been tested in community settings. This report presents the rationale and design of a randomized pilot study testing the feasibility and preliminary efficacy of small monetary incentives for PA (n=25) versus charitable donations in the same amount (n=25) versus control (n=25) over 12months among 75 low-active but otherwise healthy adults at a local YMCA. Incentives are based on YMCA attendance, which is verified by electronic swipe card data and is the primary study outcome, with self-reported minutes/week of PA assessed as a secondary outcome. Incentives are intentionally small enough-$1/session, maximum of $5/week-such that they could be indefinitely sustained by community organizations, privately-owned health clubs, healthcare organizations, or employers (e.g., employer fitness facilities). Costs of the incentive program for the sponsoring organization may be partially offset by increases in membership resulting from the appeal of the program. Moreover, if efficacious, the charitable donation incentive program may have the added benefit of building social capital for the sponsoring organization and potentially serving as a tax write-off, thus further offsetting the cost of the incentives. Findings will also have implications for the use of financially sustainable community-based incentive programs for other health-related behaviors (e.g., weight loss, smoking). Copyright © 2018 Elsevier Inc. All rights reserved.

Weight loss intervention for young adults using mobile technology: design and rationale of a randomized controlled trial - Cell Phone Intervention for You (CITY).

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Batch, Bryan C; Tyson, Crystal; Bagwell, Jacqueline; Corsino, Leonor; Intille, Stephen; Lin, Pao-Hwa; Lazenka, Tony; Bennett, Gary; Bosworth, Hayden B; Voils, Corrine; Grambow, Steven; Sutton, Aziza; Bordogna, Rachel; Pangborn, Matthew; Schwager, Jenifer; Pilewski, Kate; Caccia, Carla; Burroughs, Jasmine; Svetkey, Laura P

2014-03-01

The obesity epidemic has spread to young adults, leading to significant public health implications later in adulthood. Intervention in early adulthood may be an effective public health strategy for reducing the long-term health impact of the epidemic. Few weight loss trials have been conducted in young adults. It is unclear what weight loss strategies are beneficial in this population. To describe the design and rationale of the NHLBI-sponsored Cell Phone Intervention for You (CITY) study, which is a single center, randomized three-arm trial that compares the impact on weight loss of 1) a behavioral intervention that is delivered almost entirely via cell phone technology (Cell Phone group); and 2) a behavioral intervention delivered mainly through monthly personal coaching calls enhanced by self-monitoring via cell phone (Personal Coaching group), each compared to 3) a usual care, advice-only control condition. A total of 365 community-dwelling overweight/obese adults aged 18-35 years were randomized to receive one of these three interventions for 24 months in parallel group design. Study personnel assessing outcomes were blinded to group assignment. The primary outcome is weight change at 24 [corrected] months. We hypothesize that each active intervention will cause more weight loss than the usual care condition. Study completion is anticipated in 2014. If effective, implementation of the CITY interventions could mitigate the alarming rates of obesity in young adults through promotion of weight loss. ClinicalTrial.gov: NCT01092364. Published by Elsevier Inc.

Rationale and methods of discovering hormetins as drugs for healthy ageing

DEFF Research Database (Denmark)

Rattan, Suresh I S

2012-01-01

hormetins. Areas covered: Almost fifty years of modern biogerontolgical research has established a clear framework regarding the biological basis of aging and longevity, and it is now generally accepted that aging occurs in spite of the presence of complex pathways of maintenance, repair and defence...... development based in the ideas of hormesis and by following the strategy described here is a skin care cosmetic. Expert opinion: As a biomedical issue, the biological process of aging underlies several major diseases, and although the optimal treatment of every disease, irrespective of age, is a social......Introduction: Mild stress-induced hormesis is becoming increasingly attractive as an aging interventional strategy, and is leading to the discovery of hormesis-inducing compounds called homretins. This review gives the background, rationale and approaches for screening, testing and developing novel...

A pragmatic cluster randomised controlled trial to evaluate the safety, clinical effectiveness, cost effectiveness and satisfaction with point of care testing in a general practice setting - rationale, design and baseline characteristics.

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Laurence, Caroline; Gialamas, Angela; Yelland, Lisa; Bubner, Tanya; Ryan, Philip; Willson, Kristyn; Glastonbury, Briony; Gill, Janice; Shephard, Mark; Beilby, Justin

2008-08-06

Point of care testing (PoCT) may be a useful adjunct in the management of chronic conditions in general practice (GP). The provision of pathology test results at the time of the consultation could lead to enhanced clinical management, better health outcomes, greater convenience and satisfaction for patients and general practitioners (GPs), and savings in costs and time. It could also result in inappropriate testing, increased consultations and poor health outcomes resulting from inaccurate results. Currently there are very few randomised controlled trials (RCTs) in GP that have investigated these aspects of PoCT. The Point of Care Testing in General Practice Trial (PoCT Trial) was an Australian Government funded multi-centre, cluster randomised controlled trial to determine the safety, clinical effectiveness, cost effectiveness and satisfaction of PoCT in a GP setting.The PoCT Trial covered an 18 month period with the intervention consisting of the use of PoCT for seven tests used in the management of patients with diabetes, hyperlipidaemia and patients on anticoagulant therapy. The primary outcome measure was the proportion of patients within target range, a measure of therapeutic control. In addition, the PoCT Trial investigated the safety of PoCT, impact of PoCT on patient compliance to medication, stakeholder satisfaction, cost effectiveness of PoCT versus laboratory testing, and influence of geographic location. The paper provides an overview of the Trial Design, the rationale for the research methodology chosen and how the Trial was implemented in a GP environment. The evaluation protocol and data collection processes took into account the large number of patients, the broad range of practice types distributed over a large geographic area, and the inclusion of pathology test results from multiple pathology laboratories.The evaluation protocol developed reflects the complexity of the Trial setting, the Trial Design and the approach taken within the funding

A review of the scientific rationale and methods used in the search for other planetary systems

Science.gov (United States)

Black, D. C.

1985-01-01

Planetary systems appear to be one of the crucial links in the chain leading from simple molecules to living systems, particularly complex (intelligent?) living systems. Although there is currently no observational proof of the existence of any planetary system other than our own, techniques are now being developed which will permit a comprehensive search for other planetary systems. The scientific rationale for and methods used in such a search effort are reviewed here.

Coronary diet intervention with olive oil and cardiovascular prevention study (the CORDIOPREV study); rationale, methods, and baseline characteristics: a clinical trial comparing the efficacy of a Mediterranean diet rich...

Science.gov (United States)

Coronary heart disease (CHD) represents a major global health burden. However, despite the well-known influence that dietary habits exert over the progression of this disease, there are no well-established and scientifically sound dietary approaches to prevent the onset of clinical outcomes in secon...

Advances in clinical study of curcumin.

Science.gov (United States)

Yang, Chunfen; Su, Xun; Liu, Anchang; Zhang, Lin; Yu, Aihua; Xi, Yanwei; Zhai, Guangxi

2013-01-01

Curcumin has been estimated as a potential agent for many diseases and attracted great attention owing to its various pharmacological activities, including anti-cancer, and anti-inflammatory. Now curcumin is being applied to a number of patients with breast cancer, rheumatoid arthritis, Alzheimer's disease, colorectal cancer, psoriatic, etc. Several clinical trials have stated that curcumin is safe enough and effective. The objective of this article was to summarize the clinical studies of curcumin, and give a reference for future studies.

Prostatic Artery Embolization (PAE) for Symptomatic Benign Prostatic Hyperplasia (BPH): Part 2, Insights into the Technical Rationale

Energy Technology Data Exchange (ETDEWEB)

Sun, Fei, E-mail: feisun@ccmijesususon.com; Crisóstomo, Verónica, E-mail: crisosto@ccmijesususon.com; Báez-Díaz, Claudia, E-mail: cbaez@ccmijesususon.com; Sánchez, Francisco M., E-mail: msanchez@ccmijesususon.com [Jesús Usón Minimally Invasive Surgery Centre (Spain)

2016-02-15

Rationale of prostatic artery embolization (PAE) in the treatment of symptomatic benign prostatic hyperplasia is conventionally believed to include two parts: shrinkage of the enlarged prostate gland as a result of PAE-induced ischemic infarction and potential effects to relax the increased prostatic smooth muscle tone by reducing the number and density of α{sub 1}-adrenergic receptor in the prostate stroma. This review describes new insights into the likely mechanisms behind PAE, such as ischemia-induced apoptosis, apoptosis enhanced by blockage of androgens circulation to the embolized prostate, secondary denervation following PAE, and potential effect of nitric oxide pathway immediately after embolization. Studies on therapeutic mechanisms in PAE may shed light on potentially new treatment strategies and development of novel techniques.

Barriers to successful implementation of care in home haemodialysis (BASIC-HHD):1. Study design, methods and rationale.

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Jayanti, Anuradha; Wearden, Alison J; Morris, Julie; Brenchley, Paul; Abma, Inger; Bayer, Steffen; Barlow, James; Mitra, Sandip

2013-09-17

Ten years on from the National Institute of Health and Clinical Excellence' technology appraisal guideline on haemodialysis in 2002; the clinical community is yet to rise to the challenge of providing home haemodialysis (HHD) to 10-15% of the dialysis cohort. The renal registry report, suggests underutilization of a treatment type that has had a lot of research interest and several publications worldwide on its apparent benefit for both physical and mental health of patients. An understanding of the drivers to introducing and sustaining the modality, from organizational, economic, clinical and patient perspectives is fundamental to realizing the full benefits of the therapy with the potential to provide evidence base for effective care models. Through the BASIC-HHD study, we seek to understand the clinical, patient and carer related psychosocial, economic and organisational determinants of successful uptake and maintenance of home haemodialysis and thereby, engage all major stakeholders in the process. We have adopted an integrated mixed methodology (convergent, parallel design) for this study. The study arms include a. patient; b. organization; c. carer and d. economic evaluation. The three patient study cohorts (n = 500) include pre-dialysis patients (200), hospital haemodialysis (200) and home haemodialysis patients (100) from geographically distinct NHS sites, across the country and with variable prevalence of home haemodialysis. The pre-dialysis patients will also be prospectively followed up for a period of 12 months from study entry to understand their journey to renal replacement therapy and subsequently, before and after studies will be carried out for a select few who do commence dialysis in the study period. The process will entail quantitative methods and ethnographic interviews of all groups in the study. Data collection will involve clinical and biomarkers, psychosocial quantitative assessments and neuropsychometric tests in patients. Organizational

Design and Rationale for an In Situ Cryogenic Deformation Capability at a Neutron Source

International Nuclear Information System (INIS)

Livescu, V.; Clausen, B.; Sisneros, T.; Bourke, M.A.M.; Woodruff, T.R.; Vaidyanathan, R.; Notardonato, W.U.

2004-01-01

When performed in conjunction with neutron diffraction, in situ loading offers unique insights on microstructural deformation mechanisms. This is by virtue of the penetration and phase sensitivity of neutrons. At Los Alamos National Laboratory room and high temperature (up to 1500 deg. C) polycrystalline constitutive response is modeled using finite element and self-consistent models. The models are compared to neutron diffraction measurements. In doing so the implications of slip and creep to microstructural response have been explored. Recently we have been considering low temperature phenomena. This includes changes in deformation mechanisms such as the increased predilection for twinning over slip. Since this is associated with measurable texture changes as well as microstructural strain effects, it is well suited for study using neutron diffraction. This paper outlines the design and rationale for a cryogenic loading capability that will be used on the Spectrometer for MAterials Research at Temperature and Stress (SMARTS) at the Los Alamos Neutron Science Center (LANSCE)

The clinic-statistic study of osteoporosis

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Florin MARCU

2008-05-01

Full Text Available Osteoporosis is the most common metabolic bone disease and is characterized by the shrinkage in bone mass and the distruction of bone quality, thus conferring a higher risk for fractures and injuries. Osteoporosis reaches clinical attention when it is severe enough to induce microfractures and the collapsing of vertebral bodies manifesting with back aches or predisposition to other bone fractures. The aim of the study was to establish a statistic-numeric report between women and men in subjects diagnosed with osteoporosis through DEXA that present with a clinical simptomatology. We studied a group of subjects of masculine and feminine genders that have been diagnosed with osteoporosis through DEXA at the EURORAD clinic in Oradea from 01.01.2007-to present time .The result of the study was that the simptomatology of osteoporosis with pain and even cases of fractures is more obvious in female subjects then in male patients; statistically ,a woman/man report of 6.1/1 was established.

A Proposed Multisite Double-Blind Randomized Clinical Trial of Neurofeedback for ADHD: Need, Rationale, and Strategy

Science.gov (United States)

Kerson, Cynthia

2013-01-01

Objective: Additional treatments with persisting benefit are needed for ADHD. Because ADHD often shows excessive theta electroencephalogram (EEG) power, low beta, and excessive theta-beta ratio (TBR), a promising treatment is neurofeedback (NF) downtraining TBR. Although several nonblind randomized clinical trials (RCTs) show a medium-large…

Pedagogical and didactical rationale of phonemic stimulation process in pre-school age children

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López, Yudenia

2010-01-01

Full Text Available The paper describes the main results of a regional research problem dealing with education in pre-school age. It examines the effectiveness of the didactic conception of the process of phonemic stimulation in children from 3 to 5 years old. The pedagogical and didactic rationale of the process, viewed from the evolutionary, ontogeny, systemic perspective is explained. Likewise, possible scaffolding is illustrated. The suggested procedures focus the provision of support on a systematic and purposely practice which involve first the discrimination of non-verbal sounds and the discrimi-nation of verbal sound later, aiming to the creation of a phonological consciousness.

Clinically unrecognized miliary tuberculosis: an autopsy study.

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Savic, Ivana; Trifunovic-Skodric, Vesna; Mitrovic, Dragan

2016-01-01

Miliary tuberculosis (TB) usually presents with atypical clinical manifestations; thus it is often recognized only at autopsy. Our objectives were to study the frequency of MT diagnosed at autopsy and determine clinical diagnoses that masked TB, as well as causes of death and comorbidities. Retrospective study of all autopsies performed between 2008 and 2014. Institute of Pathology, Belgrade, Serbia. in subjects where autopsy showed the presence of MT that was not recognized clinically, we recorded the clinical diagnoses (presumed causes of death) as reported in autopsy request forms, as well as actual cause of death and comorbidities as determined at autopsy. Clinically unrecognized MT. The total number of autopsies in this period was 6206. thirty-five individuals showed clinically unrecognized MT (0.56% of all autopsies, age: 62.2 [17.2] years, M:F=2:3). Common clinical diagnoses masking pulmonary MT were exacerbation of COPD (25%) and pulmonary thromboembolism (25%), with common radiological presentation of diffuse pulmonary infiltrates (56.3%). Dominant clinical diagnoses in patients with generalized MT were adult respiratory distress syndrome, sepsis, gastrointestinal bleeding and meningoencephalitis. Disseminated MT was often associated with secondary anemia or thrombocytopenia (15.8%) and recent surgery (15.8%). Frequent comorbidities included chronic renal failure and malignancies, whereas MT was a dominant cause of death. Greater awareness of MT is needed to improve recognition in clinical settings. In particular, MT should be considered in patients with atypical clinical presentation and diffuse pulmonary infiltrates on chest X-ray, particularly if they have chronic renal failure, malignancy, hematological disorders or a history of recent surgery. None.

Rationale and study design of a clinical trial to assess the effects of LDL apheresis on proteinuria in diabetic patients with severe proteinuria and dyslipidemia.

Science.gov (United States)

Wada, Takashi; Muso, Eri; Maruyama, Shoichi; Hara, Akinori; Furuichi, Kengo; Yoshimura, Kenichi; Miyazaki, Mariko; Sato, Eiichi; Abe, Masanori; Shibagaki, Yugo; Narita, Ichiei; Yokoyama, Hitoshi; Mori, Noriko; Yuzawa, Yukio; Matsubara, Takeshi; Tsukamoto, Tatsuo; Wada, Jun; Ito, Takafumi; Masutani, Kosuke; Tsuruya, Kazuhiko; Fujimoto, Shoichi; Tsuda, Akihiro; Suzuki, Hitoshi; Kasuno, Kenji; Terada, Yoshio; Nakata, Takeshi; Iino, Noriaki; Kobayashi, Shuzo

2018-06-01

Diabetic nephropathy is a leading cause of end-stage kidney disease in the world. Although various types of treatment for diabetes, hypertension and dyslipidemia have improved prognosis and quality of life in patients with diabetic nephropathy, there still exist some diabetic patients with severe proteinuria showing poor prognosis. This clinical trial, LICENSE, aims to confirm the impact of LDL apheresis on proteinuria exhibiting hyporesponsiveness to treatment. This ongoing trial is a multicenter, prospective study of diabetic patients with severe proteinuria. The objective is to examine the impact of LDL apheresis on proteinuria in patients with diabetic nephropathy. The other subject is to investigate safety of LDL apheresis in these patients. The subjects consist of diabetic patients with serum creatinine (Cr) levels below 2 mg/dL who present severe proteinuria above 3 g/g Cr or 3 g/day and LDL cholesterol above 120 mg/dL. The target number of registered patients will be 35 patients. Urinary protein excretion and renal function will be observed for 24 weeks after the treatment of LDL apheresis. This study will determine the effectiveness and safety of LDL apheresis for diabetic nephropathy patients with severe proteinuria and dyslipidemia.

Rationale and design of a randomized double-blind clinical trial in breast cancer: dextromethorphan in chemotherapy-induced peripheral neuropathy.

Science.gov (United States)

Martin, Elodie; Morel, Véronique; Joly, Dominique; Villatte, Christine; Delage, Noémie; Dubray, Claude; Pereira, Bruno; Pickering, Gisèle

2015-03-01

Anti-cancer chemotherapy often induces peripheral neuropathy and consequent cognitive and quality of life impairment. Guidelines recommend antiepileptics or antidepressants but their efficacy is limited.Dextromethorphan, a N-methyl-D-aspartate receptor antagonist, has shown its efficacy in painful diabetic neuropathy and in post-operative pain but has not been studied in chemotherapy-induced peripheral neuropathy. This clinical trial evaluates the effect of dextromethorphan on pain, cognition and quality of life in patients who suffer from neuropathic pain induced by chemotherapy for breast cancer. It also assesses the impact of dextromethorphan genetic polymorphism on analgesia. This trial is a randomized, placebo-controlled, double-blind clinical study in two parallel groups (NCT02271893). It includes 40 breast cancer patients suffering from chemotherapy-induced peripheral neuropathy. They are randomly allocated to dextromethorphan (maximal dose 90 mg/day) or placebo for 4 weeks. The primary endpoint is pain intensity measured after 4 weeks of treatment on a (0-10) Numeric Pain Rating Scale. Secondary outcomes include assessment of neuropathic pain, cognitive function, anxiety/depression, sleep and quality of life. Data analysis is performed using mixed models and the tests are two-sided, with a type I error set at α=0.05. Considering the poor efficacy of available drugs in chemotherapy-induced neuropathic pain, dextromethorphan may be a valuable therapeutic option. Pharmacogenetics may provide predictive factors of dextromethorphan response in patients suffering from breast cancer. Copyright © 2015 Elsevier Inc. All rights reserved.

The Italian Consensus Conference on Pain in Neurorehabilitation: rationale and methodology

Directory of Open Access Journals (Sweden)

Tamburin S

2016-05-01

Full Text Available Stefano Tamburin,1 Stefano Paolucci,2 Francesca Magrinelli,1 Massimo Musicco,2,3 Giorgio Sandrini4,5 On behalf of the Italian Consensus Conference on Pain in Neurorehabilitation (ICCPN 1Department of Neurological, Biomedical and Movement Sciences, University of Verona, Verona, 2Santa Lucia Foundation, IRCCS, Rome, 3Institute of Biomedical Technologies (IBT National Research Council of Italy (CNR, Segrate, Milan, 4C. Mondino National Institute of Neurology Foundation, IRCCS, 5Department of Brain and Behavioural Sciences, University of Pavia, Pavia, Italy Abstract: Pain is very common in the neurorehabilitation setting, where it may not only represent a target for treatment but can also negatively influence rehabilitation procedures directly or through the side effects of painkillers. To date, there are neither guidelines nor consensus on how to assess and treat pain in neurorehabilitation. Because of the very scanty pieces of evidence on this topic, the Italian Consensus Conference on Pain in Neurorehabilitation (ICCPN was promoted under the auspices of different scientific societies. This article illustrates the rationale, methodology, and topics of the ICCPN. The recommendations of the ICCPN will offer some information on how to deal with pain in neurorehabilitation and may represent the starting point for further studies.Keywords: assessment, consensus conference, neurology, pain, rehabilitation, treatment

Rationale for nebivolol/valsartan combination for hypertension: review of preclinical and clinical data.

Science.gov (United States)

Giles, Thomas D; Cockcroft, John R; Pitt, Bertram; Jakate, Abhijeet; Wright, Harold M

2017-09-01

: To treat hypertension, combining two or more antihypertensive drugs from different classes is often necessary. β-Blockers and renin-angiotensin-aldosterone system inhibitors, when combined, have been deemed 'less effective' based on partially overlapping mechanisms of action and limited evidence. Recently, the single-pill combination (SPC) of nebivolol (Neb) 5 mg - a vasodilatory β1-selective antagonist/β3 agonist - and valsartan 80 mg, an angiotensin II receptor blocker, was US Food and Drug Administration-approved for hypertension. Pharmacological profiles of Neb and valsartan, alone and combined, are well characterized. In addition, a large 8-week randomized trial in stages I-II hypertensive patients (N = 4161) demonstrated greater blood pressure-reducing efficacy for Neb/valsartan SPCs than component monotherapies with comparable tolerability. In a biomarkers substudy (N = 805), Neb/valsartan SPCs prevented valsartan-induced increases in plasma renin, and a greater reduction in plasma aldosterone was observed with the highest SPC dose vs. valsartan 320 mg/day. This review summarizes preclinical and clinical evidence supporting Neb/valsartan as an efficacious and well tolerated combination treatment for hypertension.

The Danish Alzheimer intervention study

DEFF Research Database (Denmark)

Waldemar, G; Waldorff, F B; Buss, D V

2011-01-01

Background: There is a lack of appropriately designed trials investigating the efficacy of psychosocial interventions for patients with mild dementia and their family caregivers. This paper reports the rationale and design of the Danish Alzheimer Disease Intervention Study and baseline characteri......Background: There is a lack of appropriately designed trials investigating the efficacy of psychosocial interventions for patients with mild dementia and their family caregivers. This paper reports the rationale and design of the Danish Alzheimer Disease Intervention Study and baseline...

Facilitating Case Studies in Massage Therapy Clinical Education

Science.gov (United States)

Baskwill, Amanda

2013-01-01

The integration of evidence into reflective health care practice has been on the rise in recent years and is a phenomenon that has affected all health care professions, including massage therapy. Clinical case studies are a research design that follows one patient or subject, making the studies ideal for use in clinical practice. They are valuable for communicating information from clinical practice to the broader community. Case studies have face validity that may be more valuable to individual practitioners than homogeneous randomized controlled trials, as the practitioner may recognize a complex patient in the case report. At Humber College, Student Massage Therapists (SMTs) create, conduct, and communicate results of a clinical case study prior to graduation. This article describes the process and experience. PMID:23730397

Analysis and evaluation of the rationales for single-sex schooling.

Science.gov (United States)

Bigler, Rebecca S; Hayes, Amy Roberson; Liben, Lynn S

2014-01-01

Amendments passed as part of the No Child Left Behind Act in 2006 made some forms of single-sex (SS) public education legal in the United States. Proponents offer a host of arguments in favor of such schooling. This chapter identifies and evaluates five broad rationales for SS schooling. We conclude that empirical evidence fails to support proponents' claims but nonetheless suggests ways in which to improve coeducation. Specifically, we (a) show that the purported benefits of SS schooling arise from factors confounded with, but not causally linked to, single-sex composition; (b) challenge claims that biological sex is an effective marker of differences relevant to instruction; (c) argue that sexism on the part of teachers and peers persists in SS contexts; and (d) critique the notion that gender per se "disappears" in SS contexts. We also address societal implications of the use of sex-segregated education and conclude that factors found to be beneficial for students should be implemented within coeducational schools.

The Combination of Physical Exercise with Muscle-Directed Antioxidants to Counteract Sarcopenia: A Biomedical Rationale for Pleiotropic Treatment with Creatine and Coenzyme Q10

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Michele Guescini

2017-01-01

Full Text Available Sarcopenia represents an increasing public health risk due to the rapid aging of the world’s population. It is characterized by both low muscle mass and function and is associated with mobility disorders, increased risk of falls and fractures, loss of independence, disabilities, and increased risk of death. Despite the urgency of the problem, the development of treatments for sarcopenia has lagged. Increased reactive oxygen species (ROS production and decreased antioxidant (AO defences seem to be important factors contributing to muscle impairment. Studies have been conducted to verify whether physical exercise and/or AOs could prevent and/or delay sarcopenia through a normalization of the etiologically relevant ROS imbalance. Despite the strong rationale, the results obtained were contradictory, particularly with regard to the effects of the tested AOs. A possible explanation might be that not all the agents included in the general heading of “AOs” could fulfill the requisites to counteract the complex series of events causing/accelerating sarcopenia: the combination of the muscle-directed antioxidants creatine and coenzyme Q10 with physical exercise as a biomedical rationale for pleiotropic prevention and/or treatment of sarcopenia is discussed.

Integrating research into clinical internship training bridging the science/practice gap in pediatric psychology.

Science.gov (United States)

McQuaid, Elizabeth L; Spirito, Anthony

2012-03-01

Existing literature highlights a critical gap between science and practice in clinical psychology. The internship year is a "capstone experience"; training in methods of scientific evaluation should be integrated with the development of advanced clinical competencies. We provide a rationale for continued exposure to research during the clinical internship year, including, (a) critical examination and integration of the literature regarding evidence-based treatment and assessment, (b) participation in faculty-based and independent research, and (c) orientation to the science and strategy of grantsmanship. Participation in research provides exposure to new empirical models and can foster the development of applied research questions. Orientation to grantsmanship can yield an initial sense of the "business of science." Internship provides an important opportunity to examine the challenges to integrating the clinical evidence base into professional practice; for that reason, providing research exposure on internship is an important strategy in training the next generation of pediatric psychologists.

Integrating Research Into Clinical Internship Training Bridging the Science/Practice Gap in Pediatric Psychology

Science.gov (United States)

Spirito, Anthony

2012-01-01

Existing literature highlights a critical gap between science and practice in clinical psychology. The internship year is a “capstone experience”; training in methods of scientific evaluation should be integrated with the development of advanced clinical competencies. We provide a rationale for continued exposure to research during the clinical internship year, including, (a) critical examination and integration of the literature regarding evidence-based treatment and assessment, (b) participation in faculty-based and independent research, and (c) orientation to the science and strategy of grantsmanship. Participation in research provides exposure to new empirical models and can foster the development of applied research questions. Orientation to grantsmanship can yield an initial sense of the “business of science.” Internship provides an important opportunity to examine the challenges to integrating the clinical evidence base into professional practice; for that reason, providing research exposure on internship is an important strategy in training the next generation of pediatric psychologists. PMID:22286345

Towards integration of health economics into medical education and clinical practice in Saudi Arabia.

Science.gov (United States)

Da'ar, Omar B; Al Shehri, Ali M

2015-04-01

In an era of expanding health sectors and rising costs, doctors are expected to have a working knowledge of health economics to better use resources and improve outcomes and quality of health care. This article recognizes the dearth of knowledge and application of economic analyses in medical education and clinical practice in Saudi Arabia. In particular, it highlights the desirability of knowledge of health economics in ensuring certain competencies in medical education and the rationale for inviting doctors to apply knowledge of economics in Saudi Arabia. In addition, the article discusses challenges that hinder integrating health economics into clinical practice. Furthermore, the article typifies some of the important economic phenomena that physicians need to discern. Besides, the article provides implications for incorporating economic analysis into medical education and clinical practice in Saudi Arabia. Finally, the article concludes by demonstrating how health economics can enhance doctors' knowledge and recommends the country to move towards integrating health economics into medical education and clinical practice for best practice.

Prospective clinical testing of regulatory dendritic cells (DCreg in organ transplantation

Directory of Open Access Journals (Sweden)

ANGUS W THOMSON

2016-01-01

Full Text Available Dendritic cells (DC are rare, professional antigen-presenting cells with ability to induce or regulate alloimmune responses. Regulatory DC (DCreg with potential to down-modulate acute and chronic inflammatory conditions that occur in organ transplantation can be generated in vitro under a variety of conditions. Here, we provide a rationale for evaluation of DCreg therapy in clinical organ transplantation with the goal of promoting sustained, donor-specific hyporesponsiveness, while lowering the incidence and severity of rejection and reducing patients’ dependence on anti-rejection drugs. Generation of donor- or recipient-derived DCreg that suppress T cell responses and prolong transplant survival in rodents or non-human primates has been well-described. Recently, good manufacturing practice (GMP-grade DCreg have been produced at our Institution for prospective use in human organ transplantation. We briefly review experience of regulatory immune therapy in organ transplantation and describe our experience generating and characterizing human monocyte-derived DCreg. We propose a phase I/II safety study in which the influence of donor-derived DCreg combined with conventional immunosuppression on subclinical and clinical rejection and host alloimmune responses will be examined in detail.

SWITCH: rationale, design, and implementation of a community, school, and family-based intervention to modify behaviors related to childhood obesity

Directory of Open Access Journals (Sweden)

Callahan Randi

2008-06-01

Full Text Available Abstract Background Although several previous projects have attempted to address the issue of child obesity through school-based interventions, the overall effectiveness of school-based programs on health-related outcomes in youth has been poor. Thus, it has been suggested that multi-level interventions that aim to influence healthy lifestyle behaviors at the community, school and family levels may prove more successful in the prevention of childhood obesity. Methods/Design This paper describes the rationale, design, and implementation of a community-, school-, and family-based intervention aimed at modifying key behaviors (physical activity, screen time (Internet, television, video games, and nutrition related to childhood obesity among third through fifth graders in two mid-western cities. The intervention involves a randomized study of 10 schools (5 intervention and 5 control schools. The intervention is being conducted during the duration of the academic year – approximately 9 months – and includes baseline and post-intervention measurements of physical activity, dietary intake, screen time and body composition. Discussion We hope this report will be useful to researchers, public health professionals, and school administrators and health professionals (nurses and physical/health educators seeking to develop similar prevention programs. It is obvious that more collaborative, inter-disciplinary, multi-level work is needed before a proven, effective intervention package to modify behaviors related to childhood obesity can be generally recommended. It is our hope that SWITCH is a step in that direction. Trial Registration ClinicalTrials.gov NCT00685555

Biomarkers of atherosclerotic plaque vulnerability and their clinical significance

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Ran LIU

2016-09-01

Full Text Available Inflammatory reaction plays a crucial role in the occurence and development of atherosclerosis. Both basic and clinical trials have provided evidence that the expression of inflammatory biomarkers are closely related with the degree of atherosclerosis. Treatment towards inflammatory factors would bring benefit to atherosclerotic patients. This review highlighted the mechanistic rationale and specific therapies targeting traditional and novel inflammatory biomarkers, including C-reactive protein (CRP, interleukin-17 (IL-17, secretory phospholipase A2 (sPLA2, lipoprotein-associated phospholipase A2 (Lp-PLA2, endoglin, chemokine receptor and 5-lipoxygenase (5-LO, so as to review its mechanism of action and treatment prospect. DOI: 10.3969/j.issn.1672-6731.2016.09.004

Outpatient treatment of alcohol use disorders among subjects 60+ years: design of a randomized clinical trial conducted in three countries (Elderly Study).

Science.gov (United States)

Andersen, Kjeld; Bogenschutz, Michael P; Bühringer, Gerhard; Behrendt, Silke; Bilberg, Randi; Braun, Barbara; Ekstrøm, Claus Thorn; Forcehimes, Alyssa; Lizarraga, Christine; Moyers, Theresa B; Nielsen, Anette Søgaard

2015-11-14

The proportion of 60+ years with excessive alcohol intake varies in western countries between 6-16 % among men and 2-7 % among women. Specific events related to aging (e.g. loss of job, physical and mental capacity, or spouse) may contribute to onset or continuation of alcohol use disorders (AUD). We present the rationale and design of a multisite, multinational AUD treatment study for subjects aged 60+ years. 1,000 subjects seeking treatment for AUD according to DSM-5 in outpatient clinics in Denmark, Germany, and New Mexico (USA) are invited to participate in a RCT. Participants are randomly assigned to four sessions of Motivational Enhancement Treatment (MET) or to MET plus an add-on with eight sessions based on the Community Reinforcement Approach (CRA), which include a new module targeting specific problems of older adults. A series of assessment instruments is applied, including the Form-90, Alcohol Dependence Scale, Penn Alcohol Craving Scale, Brief Symptom Inventory and WHO Quality of Life. Enrolment will be completed by April 2016 and data collection by April 2017. The primary outcome is the proportion in each group who are abstinent or have a controlled use of alcohol six months after treatment initiation. Controlled use is defined as maximum blood alcohol content not exceeding 0.05 % during the last month. Total abstinence is a secondary outcome, together with quality of life andcompliance with treatment. The study will provide new knowledge about brief treatment of AUD for older subjects. As the treatment is manualized and applied in routine treatment facilities, barriers for implementation in the health care system are relatively low. Finally, as the study is being conducted in three different countries it will also provide significant insight into the possible interaction of service system differences and related patient characteristics in predictionof treatment outcome. Clinical Trials.gov NCT02084173 , March 7, 2014.

A pragmatic cluster randomised controlled trial to evaluate the safety, clinical effectiveness, cost effectiveness and satisfaction with point of care testing in a general practice setting – rationale, design and baseline characteristics

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Glastonbury Briony

2008-08-01

Full Text Available Abstract Background Point of care testing (PoCT may be a useful adjunct in the management of chronic conditions in general practice (GP. The provision of pathology test results at the time of the consultation could lead to enhanced clinical management, better health outcomes, greater convenience and satisfaction for patients and general practitioners (GPs, and savings in costs and time. It could also result in inappropriate testing, increased consultations and poor health outcomes resulting from inaccurate results. Currently there are very few randomised controlled trials (RCTs in GP that have investigated these aspects of PoCT. Design/Methods The Point of Care Testing in General Practice Trial (PoCT Trial was an Australian Government funded multi-centre, cluster randomised controlled trial to determine the safety, clinical effectiveness, cost effectiveness and satisfaction of PoCT in a GP setting. The PoCT Trial covered an 18 month period with the intervention consisting of the use of PoCT for seven tests used in the management of patients with diabetes, hyperlipidaemia and patients on anticoagulant therapy. The primary outcome measure was the proportion of patients within target range, a measure of therapeutic control. In addition, the PoCT Trial investigated the safety of PoCT, impact of PoCT on patient compliance to medication, stakeholder satisfaction, cost effectiveness of PoCT versus laboratory testing, and influence of geographic location. Discussion The paper provides an overview of the Trial Design, the rationale for the research methodology chosen and how the Trial was implemented in a GP environment. The evaluation protocol and data collection processes took into account the large number of patients, the broad range of practice types distributed over a large geographic area, and the inclusion of pathology test results from multiple pathology laboratories. The evaluation protocol developed reflects the complexity of the Trial setting

Clinical practice guidelines for hypothyroidism in adults: cosponsored by the American Association of Clinical Endocrinologists and the American Thyroid Association.

Science.gov (United States)

Garber, Jeffrey R; Cobin, Rhoda H; Gharib, Hossein; Hennessey, James V; Klein, Irwin; Mechanick, Jeffrey I; Pessah-Pollack, Rachel; Singer, Peter A; Woeber, Kenneth A

2012-12-01

Hypothyroidism has multiple etiologies and manifestations. Appropriate treatment requires an accurate diagnosis and is influenced by coexisting medical conditions. This paper describes evidence-based clinical guidelines for the clinical management of hypothyroidism in ambulatory patients. The development of these guidelines was commissioned by the American Association of Clinical Endocrinologists (AACE) in association with American Thyroid Association (ATA). AACE and the ATA assembled a task force of expert clinicians who authored this article. The authors examined relevant literature and took an evidence-based medicine approach that incorporated their knowledge and experience to develop a series of specific recommendations and the rationale for these recommendations. The strength of the recommendations and the quality of evidence supporting each was rated according to the approach outlined in the American Association of Clinical Endocrinologists Protocol for Standardized Production of Clinical Guidelines-2010 update. Topics addressed include the etiology, epidemiology, clinical and laboratory evaluation, management, and consequences of hypothyroidism. Screening, treatment of subclinical hypothyroidism, pregnancy, and areas for future research are also covered. Fifty-two evidence-based recommendations and subrecommendations were developed to aid in the care of patients with hypothyroidism and to share what the authors believe is current, rational, and optimal medical practice for the diagnosis and care of hypothyroidism. A serum thyrotropin is the single best screening test for primary thyroid dysfunction for the vast majority of outpatient clinical situations. The standard treatment is replacement with L-thyroxine. The decision to treat subclinical hypothyroidism when the serum thyrotropin is less than 10 mIU/L should be tailored to the individual patient.

Clinical studies in orthodontics--an overview of NIDR-sponsored clinical orthodontic studies in the US.

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Baumrind, S

1998-11-01

A number of clinical trials sponsored by the National Institutes of Health (NIH) use rigorous methods of data acquisition and analysis previously developed in fundamental biology and the physical sciences. The naive expectation that these trials would lead relatively rapidly to definitive answers concerning the therapeutic strategies and techniques under study is dispelled. This presentation focuses on delineating differences between the study of central tendencies and individual variation, more specifically on the strategy to study this variation: measure additional sources of variance within each patient at more timepoints and perhaps with greater precision. As rigorous orthodontic research is still in its infancy, the problem of defining the proper mix between prospective and retrospective trials is discussed. In view of the high costs of prospective clinical trials, many of the questions germane to orthodontics can be answered by well-conducted retrospective trials, assuming that properly randomized sampling procedures are employed. Definitive clinical trials are likely to require better theoretical constructs, better instrumentation, and better measures than now available. Reasons for concern are the restricted resources available and the fact that current mensurational approaches may not detect many of the individual differences. The task of constructing sharable databases and record bases stored in digital form and available either remotely from servers, or locally from CD-ROMs or optical disks, is crucial to the optimization of future investigations.

Energetic rationale for an unexpected and abrupt reversal of guanidinium chloride-induced unfolding of peptide deformylase.

Science.gov (United States)

Berg, Alexander K; Manokaran, Sumathra; Eiler, Daniel; Kooren, Joel; Mallik, Sanku; Srivastava, D K

2008-01-01

Peptide deformylase (PDF) catalyzes the removal of formyl group from the N-terminal methionine residues of nascent proteins in prokaryotes, and this enzyme is a high priority target for antibiotic design. In pursuit of delineating the structural-functional features of Escherichia coli PDF (EcPDF), we investigated the mechanistic pathway for the guanidinium chloride (GdmCl)-induced unfolding of the enzyme by monitoring the secondary structural changes via CD spectroscopy. The experimental data revealed that EcPDF is a highly stable enzyme, and it undergoes slow denaturation in the presence of varying concentrations of GdmCl. The most interesting aspect of these studies has been the abrupt reversal of the unfolding pathway at low to moderate concentrations of the denaturant, but not at high concentration. An energetic rationale for such an unprecedented feature in protein chemistry is offered.

The role of Amazonian anthropogenic soils in shifting cultivation: learning from farmers' rationales

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André B. Junqueira

2016-03-01

Full Text Available We evaluated farmers' rationales to understand their decision making in relation to the use of fertile anthropogenic soils, i.e., Amazonian dark earths (ADE, and for dealing with changes in shifting cultivation in Central Amazonia. We analyzed qualitative information from 196 interviews with farmers in 21 riverine villages along the Madeira River. In order to decide about crop management options to attain their livelihood objectives, farmers rely on an integrated and dynamic understanding of their biophysical and social environment. Farmers associate fallow development with higher crop yields and lower weed pressure, but ADE is always associated with high yields and high weeding requirements. Amazonian dark earths are also seen as an opportunity to grow different crops and/or grow crops in more intensified management systems. However, farmers often maintain simultaneously intensive swiddens on ADE and extensive swiddens on nonanthropogenic soils. Farmers acknowledge numerous changes in their socioeconomic environment that affect their shifting cultivation systems, particularly their growing interaction with market economies and the incorporation of modern agricultural practices. Farmers considered that shifting cultivation systems on ADE tend to be more prone to changes leading to intensification, and we identified cases, e.g., swiddens used for watermelon cultivation, in which market demand led to overintensification and resulted in ADE degradation. This shows that increasing intensification can be a potential threat to ADE and can undermine the importance of these soils for agricultural production, for the conservation of agrobiodiversity, and for local livelihoods. Given that farmers have an integrated knowledge of their context and respond to socioeconomic and agro-ecological changes in their environment, we argue that understanding farmers' knowledge and rationales is crucial to identify sustainable pathways for the future of ADE and of

A randomised trial of the Flinders Program to improve patient self-management competencies in a range of chronic conditions: study rationale and protocol

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Malcolm W. Battersby

2010-03-01

Full Text Available BackgroundSupporting self management is seen as an important healthservice strategy in dealing with the large and increasing healthburden of chronic conditions. Several types of selfmanagementprograms are available. Evidence to datesuggests that disease-specific and lay-led self managementprograms provide only part of the support needed forimproved outcomes. The Flinders Program is promising as ageneric self management intervention, which can becombined with targeted disease-specific and lay-ledinterventions, but it has yet to be evaluated for a range ofchronic conditions using a rigorous controlled trial design. Thispaper gives the rationale for a randomised controlled trial andprocess evaluation of the Flinders Program of chroniccondition self-management in community practice, and detailsand justifies the design of such a study.MethodThe design for a randomised trial and associated processevaluation, suited to evaluation of a complex and behaviouralintervention as it is applied in actual practice, is presented andjustified.ConclusionA randomised trial of the Flinders Program is required and afunctional design is presented. Results from this trial,currently underway, will test the effectiveness of the FlindersProgram in improving patient competencies in selfmanagementof chronic conditions in practice conditions.A process evaluation alongside the trial will exploresystem, provider and patient factors associated withgreater and lesser Program effectiveness.

Delay in the histopathologic diagnosis of mycosis fungoides

DEFF Research Database (Denmark)

Guldhammer Skov, Anne; Gniadecki, Robert

2015-01-01

The diagnosis of mycosis fungoides (MF) is difficult in early stages and is based on a combination of clinical findings and histopathologic criteria. The aim of this study was to assess the diagnostic delay in MF and to investigate the rationale for multiple biopsies in a single-centre, retrospec......The diagnosis of mycosis fungoides (MF) is difficult in early stages and is based on a combination of clinical findings and histopathologic criteria. The aim of this study was to assess the diagnostic delay in MF and to investigate the rationale for multiple biopsies in a single...

Clinical studies of biomarkers in suicide prediction

OpenAIRE

Jokinen, Jussi

2007-01-01

Suicide is a major clinical problem in psychiatry and suicidal behaviours can be seen as a nosological entity per se. Predicting suicide is difficult due to its low base-rate and the limited specificity of clinical predictors. Prospective biological studies suggest that dysfunctions in the hypothalamo pituitary adrenal (HPA) axis and the serotonergic system have predictive power for suicide in mood disorders. Suicide attempt is the most robust clinical predictor making suici...

Left ventricular noncompaction: Clinical-echocardiographic study

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Nikolić Aleksandra

2012-01-01

Full Text Available Background/Aim. Left ventricular noncompaction (LVNC is a disorder in endomyocardial morphogenesis, seen either isolated (in the absence of other cardiac anomalies or in association with congenital heart disease and some neuromuscular diseases. Intrauterine arrest of the compaction of myocardial fibers is postulated to be the reason of LVNC. Recognition of this condition is extremely important due to its high mortality and morbidity that lead to progressive heart failure, ventricular arrhythmias and thromboembolic events. The aim of this study was to determine the prevalence and clinical presentation of LVNC among consecutive outpatients according to clinical and echocardiographyic findings. Methode. A total of 3,854 consecutive patients examined at the Institute for Cardiovascular Diseases within a period January 2006 - January 2007 were included in the study. All the patients underwent echocardiographic examination using the same equipment (Vivid 7, GE Medical System. Echocardiographic parameters and clinical presentation in patients with echocardiographic criteria for LVNC were analyzed. Results. Analyzing 3,854 consecutive outpatients, using two-dimensional Color Doppler echocardiography from January 2006 to January 2007, 12 patients met the criteria for LVNC. Seven of them were male. The mean age at diagnosis was 45 ± 15 years. Analyzing clinical manifestation of LVNC it was found that seven patients had signs of heart failure, six had arrhythmias with no embolic events. Conclusion. Our results suggest that the real prevalence of LVNC may be higher than expected. New studies have to be done to solve this problem.

Cognitive remediation in pediatric chronic kidney disease and end-stage kidney disease: rationale, candidate interventions, and applicability.

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Javalkar, Karina; Ferris, Maria E; Cuttance, Jessica; Hooper, Stephen R

2017-11-01

The purpose of this paper is to address the potential use of cognitive remediation interventions for children and adolescents with chronic kidney disease (CKD) and end-stage kidney disease (ESKD). The prevalence and risk for neurocognitive dysfunction in children with this condition remains high, but, to date, interventions targeting these challenges have not been attempted either individually or as part of a larger treatment program. This is the next logical step in addressing the neurocognitive dysfunction that can be present in pediatric CKD/ESKD, with the field needing to determine the efficacy of cognitive remediation approaches for this population. To our knowledge, this paper is the first to raise this possibility by identifying candidate treatments addressing the neurocognitive challenges observed in children and adolescents with CKD/ESKD. Initially, we present the rationale for the importance of addressing the cognitive difficulties in this population, including an overview of the literature documenting the neurocognitive deficits associated with pediatric-onset CKD/ESKD. This is followed by a review of five candidate cognitive remediation programs that may be applicable to patients with this condition, and associated factors that could affect such treatment. The paper concludes with suggestions for both clinical and research initiatives that could be implemented to examine cognitive remediation as potential components of a larger treatment program for children and adolescents with CKD/ESKD.

Achievement of recommended glucose and blood pressure targets in patients with type 2 diabetes and hypertension in clinical practice – study rationale and protocol of DIALOGUE

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Gitt Anselm K

2012-12-01

Full Text Available Abstract Background Patients with type 2 diabetes have 2–4 times greater risk for cardiovascular morbidity and mortality than those without, and this is even further aggravated if they also suffer from hypertension. Unfortunately, less than one third of hypertensive diabetic patients meet blood pressure targets, and more than half fail to achieve target HbA1c values. Thus, appropriate blood pressure and glucose control are of utmost importance. Since treatment sometimes fails in clinical practice while clinical trials generally suggest good efficacy, data from daily clinical practice, especially with regard to the use of newly developed anti-diabetic and anti-hypertensive compounds in unselected patient populations, are essential. The DIALOGUE registry aims to close this important gap by evaluating different treatment approaches in hypertensive type 2 diabetic patients with respect to their effectiveness and tolerability and their impact on outcomes. In addition, DIALOGUE is the first registry to determine treatment success based on the new individualized treatment targets recommended by the ADA and the EASD. Methods DIALOGUE is a prospective observational German multicentre registry and will enrol 10,000 patients with both diabetes and hypertension in up to 700 sites. After a baseline visit, further documentations are scheduled at 6, 12 and 24 months. There are two co-primary objectives referring to the most recent guidelines for the treatment of diabetes and hypertension: 1 individual HbA1c goal achievement with respect to anti-diabetic pharmacotherapy and 2 individual blood pressure goal achievement with different antihypertensive treatments. Among the secondary objectives the rate of major cardio-vascular and cerebro-vascular events (MACCE and the rate of hospitalizations are the most important. Conclusion The registry will be able to gain insights into the reasons for the obvious gap between the demonstrated efficacy and safety of anti

Controlled study of myocardial recovery after interval training in heart failure: SMARTEX-HF - rationale and design

DEFF Research Database (Denmark)

Støylen, Asbjørn; Conraads, Viviane; Halle, Martin

2011-01-01

in patients with chronic heart failure. However, the size of beneficial effects was modest compared to results published in smaller single studies and meta-analyses. Objective: Based on results of a pilot study, the objective of the present investigation is to test the hypothesis that a programme comprising...... number of 200 patients on treatment per protocol, randomized to the three groups in a 1 : 1 : 1 manner, is estimated to detect clinically relevant differences in effect with HIT vs. MCT and RE (p run...

Rationale for the use of radiolabelled peptides in diagnosis and therapy

Energy Technology Data Exchange (ETDEWEB)

Koopmans, K.P. [Martini Hospital, Department of Radiology and Nuclear Medicine, Groningen (Netherlands); Glaudemans, A.W.J.M. [University of Groningen, Department of Nuclear Medicine and Molecular Imaging, University Medical Center Groningen, Groningen (Netherlands)

2012-02-15

Nuclear medicine techniques are becoming more important in imaging oncological and infectious diseases. For metabolic imaging of these diseases, antibody and peptide imaging are currently used. In recent years peptide imaging has become important, therefore the rationale for the use of peptide imaging is described in this article. Criteria for a successful peptide tracer are a high target specificity, a high binding affinity, a long metabolic stability and a high target-to-background ratio. Tracer internalization is also beneficial. For oncological imaging, many tracers are available, most originating from regulatory peptides, but penetrating peptides are also being developed. Peptides for imaging inflammatory and infectious diseases include regulatory peptides, antimicrobial peptides and others. In conclusion, for the imaging of oncological, inflammatory and infectious diseases, many promising peptides are being developed. The ideal peptide probe is characterized by rapid and specific target localization and binding with a high tumour-to-background ratio. (orig.)

Challenges in implementing clinical governance: A qualitative study ...

African Journals Online (AJOL)

Design: A qualitative study. Setting: Hospitals affiliated to Shahid Sadoughi University of Medical Sciences in Yazd, Iran. Subjects: Thirteen participants selected among clinical governance executives of under study hospitals and members of clinical governance office in curative deputy of the University. Results: Eight major ...

Understanding Water Storage Practices of Urban Residents of an Endemic Dengue Area in Colombia: Perceptions, Rationale and Socio-Demographic Characteristics.

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Tatiana García-Betancourt

Full Text Available The main preventive measure against dengue virus transmission is often based on actions to control Ae. Aegypti reproduction by targeting water containers of clean and stagnant water. Household water storage has received special attention in prevention strategies but the evidence about the rationale of this human practice is limited. The objective was to identify and describe water storage practices among residents of an urban area in Colombia (Girardot and its association with reported perceptions, rationales and socio-demographic characteristics with a mixed methods approach.Knowledge, attitudes and practices and entomological surveys from 1,721 households and 26 semi-structured interviews were conducted among residents of Girardot and technicians of the local vector borne disease program. A multivariate analysis was performed to identify associations between a water storage practice and socio-demographic characteristics, and knowledge, attitudes and practices about dengue and immature forms of the vector, which were then triangulated with qualitative information.Water storage is a cultural practice in Girardot. There are two main reasons for storage: The scarcity concern based on a long history of shortages of water in the region and the perception of high prices in water rates, contrary to what was reported by the local water company. The practice of water storage was associated with being a housewife (Inverse OR: 2.6, 95% CI 1.5 -4.3. The use of stored water depends on the type of container used, while water stored in alberca (Intra household cement basins is mainly used for domestic cleaning chores, water in plastic containers is used for cooking.It is essential to understand social practices that can increase or reduce the number of breeding sites of Ae. Aegypti. Identification of individuals who store water and the rationale of such storage allow a better understanding of the social dynamics that lead to water accumulation.

Muscle Metabolic Responses During Dynamic In-Magnet Exercise Testing : A Pilot Study in Children with an Idiopathic Inflammatory Myopathy

NARCIS (Netherlands)

van Brussel, Marco; van Oorschot, Joep W. M.; Schmitz, Joep P. J.; Nicolay, Klaas; van Royen-Kerkhof, Annet; Takken, Tim; Jeneson, Jeroen A. L.

Rationale and Objectives: The clinical utility of supine in-magnet bicycling in combination with phosphorus magnetic resonance spectroscopy (P-31 MRS) to evaluate quadriceps muscle metabolism was examined in four children with juvenile dermatomyositis (JDM) in remission and healthy age- and

Money Laundering, Corruption and Growth: An Empirical Rationale for a Global Convergence on Anti-Money Laundering Regulation

OpenAIRE

Cavalcante Veiga, Luiz Humberto; Andrade, Joaquim Pinto

2006-01-01

This paper provides empirical evidence on the impact of anti-money laundering regulations on growth and, it examines the rationale for a global adoption of these rules. The empirical results have led us to confirm a positive relation between low corruption levels and high investment and growth. We approached the impact on growth of money laundering prevention (MLP) initiatives in two ways: first, by verifying that the existence of these initiatives affects the perception of corruption. Second...

Clinical caring science as a scientific discipline.

Science.gov (United States)

Rehnsfeldt, Arne; Arman, Maria; Lindström, Unni Å

2017-09-01

Clinical caring science will be described from a theory of science perspective. The aim of this theoretical article to give a comprehensive overview of clinical caring science as a human science-based discipline grounded in a theory of science argumentation. Clinical caring science seeks idiographic or specific variations of the ontology, concepts and theories, formulated by caring science. The rationale is the insight that the research questions do not change when they are addressed in different contexts. The academic subject contains a concept order with ethos concepts, core and basic concepts and practice concepts that unites systematic caring science with clinical caring science. In accordance with a hermeneutic tradition, the idea of the caring act is based on the degree to which the theory base is hermeneutically appropriated by the caregiver. The better the ethos, essential concepts and theories are understood, the better the caring act can be understood. In order to understand the concept order related to clinical caring science, an example is given from an ongoing project in a disaster context. The concept order is an appropriate way of making sense of the essence of clinical caring science. The idea of the concept order is that concepts on all levels need to be united with each other. A research project in clinical caring science can start anywhere on the concept order, either in ethos, core concepts, basic concepts, practice concepts or in concrete clinical phenomena, as long as no parts are locked out of the concept order as an entity. If, for example, research on patient participation as a phenomenon is not related to core and basic concepts, there is a risqué that the research becomes meaningless. © 2016 Nordic College of Caring Science.

Effects of Mindfulness on Diabetes Mellitus: Rationale and Overview.

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Medina, Wilson L; Wilson, David; de Salvo, Vera; Vannucchi, Bruna; de Souza, Érika Leonardo; Lucena, Leandro; Sarto, Héctor Morillo; Modrego-Alarcón, Marta; Garcia-Campayo, Javier; Demarzo, Marcelo

2017-01-01

Diabetes mellitus (DM) is an emerging global healthcare problem and its prevalence is increasing at an alarming rate. Despite improvements in both medical and pharmacological therapies, a complex medical condition may demand a diversified approach, such as: drug therapy, healthy diet and exercises, diabetes education programs, adherence to medical treatment and active participation of the patients in their lifestyle changes, such as stress management. The concept of mindfulness is here defined as the awareness that unfolds from the intention to attentively observe the current experience in a non-judgmental and non-evaluative way. This state of awareness can be enhanced through the use of mindfulness-based interventions (MBIs), which have been associated to many physical and psychological health indicators. The aim of this overview is to offer the rationale and potential benefits of mindfulness in the control of DM and its complications. a narrative review of the current and updated literature available on online database and which came up using the terms "mindfulness" and "diabetes mellitus". Mindfulness-based Interventions (MBIs) can be seen as preventive and complementary interventions in DM, particularly for the relief of symptoms related to depression and anxiety in diabetic patients and also in the management of other factors, including mindful eating, physical exercises and treatment adherence. Although many studies only present research protocols, mindfulness seems to have beneficial effects on all aspects of diabetes, including incidence, control and complications. Furthermore, longer term and more carefully controlled trials are necessary in order to draw consistent conclusions on the beneficial role of MBIs on DM. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Design and rationale of the HCC BRIDGE study in China: a longitudinal, multicenter cohort trial in hepatocellular carcinoma

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Qiao You-Lin

2011-05-01

Full Text Available Abstract Background More than 50% of the worldwide cases of hepatocellular carcinoma occur in China, and this malignancy currently represents the country's second leading cause of cancer death in cities and the leading cause in rural areas. Despite recent advances in the control and management of hepatocellular carcinoma within China, this disease remains a major health care issue. The global HCC BRIDGE study, designed to assess patterns of hepatocellular carcinoma therapy use and associated outcomes across real-world clinical practice, has recently been expanded as a national study in China, allowing a detailed analysis of hepatocellular carcinoma in this important country. Methods/Design The global HCC BRIDGE study is a multiregional longitudinal cohort trial including patients newly diagnosed with hepatocellular carcinoma between January 1, 2005, and June 30, 2011, who are receiving treatment for hepatocellular carcinoma via sites in the Asia-Pacific, European, and North American regions. The HCC BRIDGE China national study comprises the portion of the global HCC BRIDGE study conducted within mainland China. Patients will be followed from time of diagnosis of hepatocellular carcinoma (post-January 1, 2005 to time of death or December 31, 2011, whichever comes first. Data will be collected on demographic/clinical characteristics, relevant laboratory values, hepatocellular carcinoma/underlying liver disease treatment, tumor response, adverse events, hospitalizations, and overall survival. The primary study end point is overall survival; secondary end points are disease progression, treatment-limiting adverse events, and treatment failure. Results At the time of writing, 15 sites have selected for participation across all 7 traditional regions of China (North, North-East, East, South, South-West, North-West, and Central. The anticipated study population from the China national study is approximately 9000 patients. Discussion Findings from the

Non-clinical studies in the process of new drug development - Part II: Good laboratory practice, metabolism, pharmacokinetics, safety and dose translation to clinical studies.

Science.gov (United States)

Andrade, E L; Bento, A F; Cavalli, J; Oliveira, S K; Schwanke, R C; Siqueira, J M; Freitas, C S; Marcon, R; Calixto, J B

2016-12-12

The process of drug development involves non-clinical and clinical studies. Non-clinical studies are conducted using different protocols including animal studies, which mostly follow the Good Laboratory Practice (GLP) regulations. During the early pre-clinical development process, also known as Go/No-Go decision, a drug candidate needs to pass through several steps, such as determination of drug availability (studies on pharmacokinetics), absorption, distribution, metabolism and elimination (ADME) and preliminary studies that aim to investigate the candidate safety including genotoxicity, mutagenicity, safety pharmacology and general toxicology. These preliminary studies generally do not need to comply with GLP regulations. These studies aim at investigating the drug safety to obtain the first information about its tolerability in different systems that are relevant for further decisions. There are, however, other studies that should be performed according to GLP standards and are mandatory for the safe exposure to humans, such as repeated dose toxicity, genotoxicity and safety pharmacology. These studies must be conducted before the Investigational New Drug (IND) application. The package of non-clinical studies should cover all information needed for the safe transposition of drugs from animals to humans, generally based on the non-observed adverse effect level (NOAEL) obtained from general toxicity studies. After IND approval, other GLP experiments for the evaluation of chronic toxicity, reproductive and developmental toxicity, carcinogenicity and genotoxicity, are carried out during the clinical phase of development. However, the necessity of performing such studies depends on the new drug clinical application purpose.

The need for PGY2-trained clinical pharmacy specialists.

Science.gov (United States)

Ragucci, Kelly R; O'Bryant, Cindy L; Campbell, Kristin Bova; Buck, Marcia L; Dager, William E; Donovan, Jennifer L; Emerson, Kayleigh; Gubbins, Paul O; Haight, Robert J; Jackevicius, Cynthia; Murphy, John E; Prohaska, Emily

2014-06-01

The American College of Clinical Pharmacy and other stakeholder organizations seek to advance clinical pharmacist practitioners, educators, and researchers. Unfortunately, there remains an inadequate supply of residency-trained clinical specialists to meet the needs of our health care system, and nonspecialists often are called on to fill open specialist positions. The impact of clinical pharmacy specialists on pharmacotherapy outcomes in both acute care and primary care settings demonstrates the value of these specialists. This commentary articulates the need for postgraduate year two (PGY2)-trained clinical specialists within the health care system by discussing various clinical and policy rationales, interprofessional support, economic justifications, and their impact on quality of care and drug safety. The integrated practice model that has grown out of the American Society of Health-System Pharmacists Pharmacy Practice Model Initiative (PPMI) could threaten the growth and development of future clinical specialists. Therefore, the ways in which PGY2-trained clinical pharmacist specialists are deployed in the PPMI require further consideration. PGY2 residencies provide education and training opportunities that cannot be achieved in traditional professional degree programs or postgraduate year one residencies. These specialists are needed to provide direct patient care to complex patient populations and to educate and train pharmacy students and postgraduate residents. Limitations to training and hiring PGY2-trained clinical pharmacy specialists include site capacity limitations and lack of funding. A gap analysis is needed to define the extent of the mismatch between the demand for specialists by health care systems and educational institutions versus the capacity to train clinical pharmacists at the specialty level. © 2014 Pharmacotherapy Publications, Inc.

Design Rationale Behind the Serious Self-Regulation Game Intervention "Balance It": Overweight Prevention Among Secondary Vocational Education Students in The Netherlands.

Science.gov (United States)

Spook, Jorinde E; Paulussen, Theo; Paulissen, Rosie; Visschedijk, Gillian; Kok, Gerjo; van Empelen, Pepijn

2015-10-01

This article describes the design rationale behind a serious self-regulation game intervention. The aim of the game is to promote healthy dietary intake and physical activity among secondary vocational educational students in The Netherlands (approximately 16-20 years of age). The game "Balance It" was developed according to an intervention mapping (IM) protocol. Following IM, we specified health promotion and usability objectives and linked these objectives to selected behavior change and persuasive methods. Accordingly, these methods were translated into a coherent intervention program. The health behavior change objectives were derived from the determinants of the behavior and from Self-Regulation Theory (e.g., students are asked to set goals, monitor and evaluate their behavior, and create coping plans). Usability objectives were derived from the RE-AIM model (i.e., Reach, Effectiveness, Adoption, Implementation, and Maintenance). Next, behavior change and persuasive techniques were selected (e.g., goal setting and prompting, respectively) that did fit with the targeted change objectives and were translated in the design of a (mobile) serious self-regulation game intervention. Subsequently, three concept and usability tests were performed to improve intervention usability, and an evaluation plan was developed. The aim of this study was to provide a design rationale for game interventions targeting health-related behaviors. We developed a coherent program design in which both health behavior change and usability factors are addressed. The IM protocol can serve as a useful guide for decision making in program development and evaluation.

Use of endpoint adjudication to improve the quality and validity of endpoint assessment for medical device development and post marketing evaluation: Rationale and best practices. A report from the cardiac safety research consortium.

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Seltzer, Jonathan H; Heise, Ted; Carson, Peter; Canos, Daniel; Hiatt, Jo Carol; Vranckx, Pascal; Christen, Thomas; Cutlip, Donald E

2017-08-01

This white paper provides a summary of presentations, discussions and conclusions of a Thinktank entitled "The Role of Endpoint Adjudication in Medical Device Clinical Trials". The think tank was cosponsored by the Cardiac Safety Research Committee, MDEpiNet and the US Food and Drug Administration (FDA) and was convened at the FDA's White Oak headquarters on March 11, 2016. Attention was focused on tailoring best practices for evaluation of endpoints in medical device clinical trials, practical issues in endpoint adjudication of therapeutic, diagnostic, biomarker and drug-device combinations, and the role of adjudication in regulatory and reimbursement issues throughout the device lifecycle. Attendees included representatives from medical device companies, the FDA, Centers for Medicare and Medicaid Services (CMS), end point adjudication specialist groups, clinical research organizations, and active, academically based adjudicators. The manuscript presents recommendations from the think tank regarding (1) rationale for when adjudication is appropriate, (2) best practices establishment and operation of a medical device adjudication committee and (3) the role of endpoint adjudication for post market evaluation in the emerging era of real world evidence. Copyright © 2017. Published by Elsevier Inc.

ACCISS study rationale and design: activating collaborative cancer information service support for cervical cancer screening.

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Cofta-Woerpel, Ludmila; Randhawa, Veenu; McFadden, H Gene; Fought, Angela; Bullard, Emily; Spring, Bonnie

2009-12-02

High-quality cancer information resources are available but underutilized by the public. Despite greater awareness of the National Cancer Institute's Cancer Information Service among low-income African Americans and Hispanics compared with Caucasians, actual Cancer Information Service usage is lower than expected, paralleling excess cancer-related morbidity and mortality for these subgroups. The proposed research examines how to connect the Cancer Information Service to low-income African-American and Hispanic women and their health care providers. The study will examine whether targeted physician mailing to women scheduled for colposcopy to follow up an abnormal Pap test can increase calls to the Cancer Information Service, enhance appropriate medical follow-up, and improve satisfaction with provider-patient communication. The study will be conducted in two clinics in ethnically diverse low-income communities in Chicago. During the formative phase, patients and providers will provide input regarding materials planned for use in the experimental phase of the study. The experimental phase will use a two-group prospective randomized controlled trial design. African American and Hispanic women with an abnormal Pap test will be randomized to Usual Care (routine colposcopy reminder letter) or Intervention (reminder plus provider recommendation to call the Cancer Information Service and sample questions to ask). Primary outcomes will be: 1) calls to the Cancer Information Service; 2) timely medical follow-up, operationalized by whether the patient keeps her colposcopy appointment within six months of the abnormal Pap; and 3) patient satisfaction with provider-patient communication at follow-up. The study examines the effectiveness of a feasible, sustainable, and culturally sensitive strategy to increase awareness and use of the Cancer Information Service among an underserved population. The goal of linking a public service (the Cancer Information Service) with real

Clinical audit of COPD in outpatient respiratory clinics in Spain: the EPOCONSUL study

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Calle Rubio M

2017-01-01

Full Text Available Myriam Calle Rubio,1–3 Bernardino Alcázar Navarrete,4 Joan B Soriano,5 Juan J Soler-Cataluña,6 José Miguel Rodríguez González-Moro,7 Manuel E Fuentes Ferrer,2,3,8 José Luis López-Campos9 On behalf of the EPOCONSUL Study 1Pulmonary Department, Hospital Clínico San Carlos, 2Department of Medicine, Faculty of Medicine, University Complutense of Madrid, 3Research Institute of Hospital Clínico San Carlos (IdISSC, Madrid, 4Pulmonary Department, Hospital de Alta Resolución de Noja, Granada, 5Research Institute of Hospital University La Princesa (IISP, University Autónoma of Madrid, 6Pulmonary Department, Hospital de Arnau de Villanova, Valencia, 7Pulmonary Department, Hospital Universitario Principe de Asturias, Alcalá de Henares, Madrid, 8UGC of Preventive Medicine and Research Institute of Hospital Clínico San Carlos, Madrid, 9Pulmonary Department, Hospital University Virgen del Rocio, Institute of Biomedicine of Sevilla (IBiS, Sevilla, Spain Background: Chronic obstructive pulmonary disease (COPD outpatients account for a large burden of usual care by respirologists. EPOCONSUL is the first national clinical audit conducted in Spain on the medical care for COPD patients delivered in outpatient respiratory clinics. We aimed to evaluate the clinical interventions and the degree of adherence to recommendations in outpatients of current COPD clinical practice guidelines.Methodology: This is an observational study with prospective recruitment (May 2014–May 2015 of patients with a COPD diagnosis as seen in outpatient respiratory clinics. The information collected was historical in nature as for the clinical data of the last and previous consultations, and the information concerning hospital resources was concurrent.Results: A total of 17,893 clinical records of COPD patients in outpatient respiratory clinics from 59 Spanish hospitals were evaluated. Of the 5,726 patients selected, 4,508 (78.7% were eligible. Overall, 12.1% of COPD patients

Clinical issues of mucus accumulation in COPD

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Osadnik CR

2014-03-01

Full Text Available Christian R Osadnik,1,2 Christine F McDonald,2,3 Anne E Holland2,4,51Department of Physiotherapy, Monash University, 2Institute for Breathing and Sleep, Austin Health, 3Department of Respiratory and Sleep Medicine, Austin Health, 4Department of Physiotherapy, La Trobe University, 5Department of Physiotherapy, Alfred Health, Melbourne, VIC, AustraliaWe wish to thank Ramos et al for presenting a succinct and up-to-date synthesis of the evidence relating to the important issue of mucus hypersecretion in COPD.1 The authors highlight the association of mucus hypersecretion with poor outcomes, including increased risk of exacerbations, hospitalization and mortality. These associations have led to interest in the potential benefits of mucus clearance techniques in COPD. As Ramos et al1 point out, although the physiological rationale for airway clearance techniques (ACTs in COPD is strong, clinical efficacy has historically been difficult to establish, perhaps due to the variety of techniques and outcomes that have been employed in small studies. We have recently synthesized this body of evidence in a Cochrane systematic review of ACTs for individuals with COPD. The review demonstrated ACTs are safe and meta-analysis showed they confer small beneficial effects on a limited range of important clinical outcomes, such as the need for and duration of ventilatory assistance during an acute exacerbation of COPD (AECOPD.2View original paper by Ramos and colleagues.

Hydroxyurea revisited: a decade of clinical effects studies

International Nuclear Information System (INIS)

Sinclair, W.K.

1981-01-01

Over a decade ago hydroxyurea was shown to selectively kill cells in the S phase in a proliferating cell population and to block cells at the G 1 -S border. Consequently, blocked cells became sensitized to irradiation and were further sensitized when the drug was present after exposure. In the ensuing decade, many in vivo studies on hydroxyurea have confirmed that the main properties of hydroxyurea identified in the dish are also evident in vivo. During a period of about ten years, a considerable number of clinical studies have been performed, the results of which have been mixed, ranging from indeterminate to encouraging, depending to some extent on the site treated and whether careful randomized studies were done. The question arises whether the clinical studies have represented adequate tests, by laboratory standards, of the likely effectiveness of the drug in clinical circumstances. The clinical studies with hydroxyurea have been examined in this light, since the results might also bear on the use of many other such agents in combination therapy. This examination revealed that no attempts have been made to determine the concentration of hydroxyurea in the tumor and other relevant tissues as a function of time or to assess the cell kinetic features of the tumor and thus estimate the appropriate dose regimen. It would seem that a wide gap still exists between laboratory research and clinical application

PRIME – PRocess modelling in ImpleMEntation research: selecting a theoretical basis for interventions to change clinical practice

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Pitts Nigel

2003-12-01

Full Text Available Abstract Background Biomedical research constantly produces new findings but these are not routinely translated into health care practice. One way to address this problem is to develop effective interventions to translate research findings into practice. Currently a range of empirical interventions are available and systematic reviews of these have demonstrated that there is no single best intervention. This evidence base is difficult to use in routine settings because it cannot identify which intervention is most likely to be effective (or cost effective in a particular situation. We need to establish a scientific rationale for interventions. As clinical practice is a form of human behaviour, theories of human behaviour that have proved useful in other similar settings may provide a basis for developing a scientific rationale for the choice of interventions to translate research findings into clinical practice. The objectives of the study are: to amplify and populate scientifically validated theories of behaviour with evidence from the experience of health professionals; to use this as a basis for developing predictive questionnaires using replicable methods; to identify which elements of the questionnaire (i.e., which theoretical constructs predict clinical practice and distinguish between evidence compliant and non-compliant practice; and on the basis of these results, to identify variables (based on theoretical constructs that might be prime targets for behaviour change interventions. Methods We will develop postal questionnaires measuring two motivational, three action and one stage theory to explore five behaviours with 800 general medical and 600 general dental practitioners. We will collect data on performance for each of the behaviours. The relationships between predictor variables (theoretical constructs and outcome measures (data on performance in each survey will be assessed using multiple regression analysis and structural equation

The place of the clock in pediatric advice: rationales, cultural themes, and impediments to breastfeeding.

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Millard, A V

1990-01-01

This analysis treats the U.S. medical literature as evidence concerning the formal system of knowledge in allopathic medicine. An examination of pediatric advice on breastfeeding reveals the logic of medical reasoning, the use of scientific rationales, and the intrusion of specific cultural themes. The corpus of data includes works of 18 authors published in 36 volumes from 1897 to 1987, 27 volumes being editions of two major pediatric textbooks. All sources advocate breastfeeding but the detailed advice on how to carry out the process actually tends to undermine it. Moreover, the clock has provided the main frame of reference, creating regimentation reminiscent of factory work, segmenting breastfeeding into a series of steps, and emphasizing efficiency in time and motion. Feeding schedules were advocated in former decades as a matter of discipline for the infant, but nowadays they are viewed as biologically innate to normal infants and to breast milk production. The literature manifests responses over the century to behavioral, biochemical and physiological studies; however, except possibly for one textbook, no thorough rethinking has occurred. Sources of the 1980s continue to focus on the tempo of feeding as a major concern. Cultural themes besides the factory model of breastfeeding include the extension of professional advice to family matters, the subordination of lay women to professional expertise, mistrust of women's bodily signals including the let-down reflex in determining the timing of feedings, mistrust of signals from infants as well, and a professional ideal of flexible advice coupled with rigid limits concerning schedules. The literature interweaves the cultural themes with rationales based on physiological studies in support of specific regimens in breastfeeding, and the relegation of control in breastfeeding to medical experts denies the validity of mutual bodily and emotional responses within the mother-infant dyad. Pediatric authorities thus

Active Learning with Rationales for Identifying Operationally Significant Anomalies in Aviation

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Sharma, Manali; Das, Kamalika; Bilgic, Mustafa; Matthews, Bryan; Nielsen, David Lynn; Oza, Nikunj C.

2016-01-01

A major focus of the commercial aviation community is discovery of unknown safety events in flight operations data. Data-driven unsupervised anomaly detection methods are better at capturing unknown safety events compared to rule-based methods which only look for known violations. However, not all statistical anomalies that are discovered by these unsupervised anomaly detection methods are operationally significant (e.g., represent a safety concern). Subject Matter Experts (SMEs) have to spend significant time reviewing these statistical anomalies individually to identify a few operationally significant ones. In this paper we propose an active learning algorithm that incorporates SME feedback in the form of rationales to build a classifier that can distinguish between uninteresting and operationally significant anomalies. Experimental evaluation on real aviation data shows that our approach improves detection of operationally significant events by as much as 75% compared to the state-of-the-art. The learnt classifier also generalizes well to additional validation data sets.

SU-F-P-51: Similarity Analysis of the Linear Accelerator Machines Based On Clinical Simulation

International Nuclear Information System (INIS)

Li, K

2016-01-01

Purpose: To evaluate the clinical rationale for Truebeam and Trilogy Linac machines from Varian Medical System as exchangeable treatment modalities in the same radiation oncology department. Methods: Intensity Modulated Radiotherapy (IMRT) plans for different diseases were selected for this study. These disease sites included brain, head and neck, breast, lung, and prostate. The parameters selected for this study were the energy amount, Monitor Unit (MU); dose coverage of target reflected by prescription isodose volume(PIV); dose spillage described by the volume of 50% isodoseline of the prescription; and dose homogeneities represented by the maximum dose (MaxD) and the minimum dose (MinD) of target volume (TV) and critical structure (CS). Each percentage difference between the values of these parameters formed an element of a matrix, which was called Similarity Comparison Matrix(SCM). The elements of the SCM were then simplified by dimensional conversion algorithm, which was used to determine clinical similarity between two machines through a single value. Results: For the selected clinical cases in this study, the average percentage differences between Trilogy and Truebeam in MU was 0.28% with standard deviation(SD) 0.66%, PIV was 0.23% with SD 0.20%, Volume at 50% prescription dose was 0.31% with SD at 0.78%, MaxD at TV is 0.26% with SD 0.35%, MinD at TV is −0.04% with SD 0.51%, MaxD in CS is −0.53% with SD 0.92%, and MinD in CS 3.31%, with SD at 2.89%. The sum, product, geometric and harmonic mean for the matrix elements were 19.0%, 0.00%, 0.19%, and 0.00%. Conclusion: A method to compare two machines in clinical level was developed and some reference values were calculated for decision-making in clinical practice, and this strategy could be expanded to different clinical applications.

SU-F-P-51: Similarity Analysis of the Linear Accelerator Machines Based On Clinical Simulation

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Li, K [Associates In Medical Physics, Lanham, MD (United States); John R Marsh Cancer Center (United States)

2016-06-15

Purpose: To evaluate the clinical rationale for Truebeam and Trilogy Linac machines from Varian Medical System as exchangeable treatment modalities in the same radiation oncology department. Methods: Intensity Modulated Radiotherapy (IMRT) plans for different diseases were selected for this study. These disease sites included brain, head and neck, breast, lung, and prostate. The parameters selected for this study were the energy amount, Monitor Unit (MU); dose coverage of target reflected by prescription isodose volume(PIV); dose spillage described by the volume of 50% isodoseline of the prescription; and dose homogeneities represented by the maximum dose (MaxD) and the minimum dose (MinD) of target volume (TV) and critical structure (CS). Each percentage difference between the values of these parameters formed an element of a matrix, which was called Similarity Comparison Matrix(SCM). The elements of the SCM were then simplified by dimensional conversion algorithm, which was used to determine clinical similarity between two machines through a single value. Results: For the selected clinical cases in this study, the average percentage differences between Trilogy and Truebeam in MU was 0.28% with standard deviation(SD) 0.66%, PIV was 0.23% with SD 0.20%, Volume at 50% prescription dose was 0.31% with SD at 0.78%, MaxD at TV is 0.26% with SD 0.35%, MinD at TV is −0.04% with SD 0.51%, MaxD in CS is −0.53% with SD 0.92%, and MinD in CS 3.31%, with SD at 2.89%. The sum, product, geometric and harmonic mean for the matrix elements were 19.0%, 0.00%, 0.19%, and 0.00%. Conclusion: A method to compare two machines in clinical level was developed and some reference values were calculated for decision-making in clinical practice, and this strategy could be expanded to different clinical applications.

Marketing and clinical trials: a case study.

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Francis, David; Roberts, Ian; Elbourne, Diana R; Shakur, Haleema; Knight, Rosemary C; Garcia, Jo; Snowdon, Claire; Entwistle, Vikki A; McDonald, Alison M; Grant, Adrian M; Campbell, Marion K

2007-11-20

Publicly funded clinical trials require a substantial commitment of time and money. To ensure that sufficient numbers of patients are recruited it is essential that they address important questions in a rigorous manner and are managed well, adopting effective marketing strategies. Using methods of analysis drawn from management studies, this paper presents a structured assessment framework or reference model, derived from a case analysis of the MRC's CRASH trial, of 12 factors that may affect the success of the marketing and sales activities associated with clinical trials. The case study demonstrates that trials need various categories of people to buy in - hence, to be successful, trialists must embrace marketing strategies to some extent. The performance of future clinical trials could be enhanced if trialists routinely considered these factors.

Rationale and study design of a patient-centered intervention to improve health status in chronic heart failure: The Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) randomized trial.

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Bekelman, David B; Allen, Larry A; Peterson, Jamie; Hattler, Brack; Havranek, Edward P; Fairclough, Diane L; McBryde, Connor F; Meek, Paula M

2016-11-01

While contemporary heart failure management has led to some improvements in morbidity and mortality, patients continue to report poor health status (i.e., burdensome symptoms, impaired function, and poor quality of life). The Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) trial is a NIH-funded, three-site, randomized clinical trial that examines the effect of the CASA intervention compared to usual care on the primary outcome of patient-reported health status at 6months in patients with heart failure and poor health status. The CASA intervention involves a nurse who works with patients to treat symptoms (e.g., shortness of breath, fatigue, pain) using disease-specific and palliative approaches, and a social worker who provides psychosocial care targeting depression and adjustment to illness. The intervention uses a collaborative care team model of health care delivery and is structured and primarily phone-based to enhance reproducibility and scalability. This article describes the rationale and design of the CASA trial, including several decision points: (1) how to design a patient-centered intervention to improve health status; (2) how to structure the intervention so that it is reproducible and scalable; and (3) how to systematically identify outpatients with heart failure most likely to need and benefit from the intervention. The results should provide valuable information to providers and health systems about the use of team care to manage symptoms and provide psychosocial care in chronic illness. Published by Elsevier Inc.

Rationale, design and methods for the RIGHT Track Health Study: pathways from childhood self-regulation to cardiovascular risk in adolescence.

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Wideman, Laurie; Calkins, Susan D; Janssen, James A; Lovelady, Cheryl A; Dollar, Jessica M; Keane, Susan P; Perrin, Eliana M; Shanahan, Lilly

2016-06-01

Cardiovascular risk factors during adolescence-including obesity, elevated lipids, altered glucose metabolism, hypertension, and elevated low-grade inflammation-is cause for serious concern and potentially impacts subsequent morbidity and mortality. Despite the importance of these cardiovascular risk factors, very little is known about their developmental origins in childhood. In addition, since adolescence is a time when individuals are navigating major life changes and gaining increasing autonomy from their parents or parental figures, it is a period when control over their own health behaviors (e.g. drug use, sleep, nutrition) also increases. The primary aim of this paper is to describe the rationale, design and methods for the RIGHT Track Health Study. This study examines self-regulation as a key factor in the development of cardiovascular risk, and further explores health behaviors as an explanatory mechanism of this association. We also examine potential moderators (e.g. psychosocial adversities such as harsh parenting) of this association. RIGHT Track is a longitudinal study that investigates social and emotional development. The RIGHT Track Health Study prospectively follows participants from age 2 through young adulthood in an effort to understand how self-regulatory behavior throughout childhood alters the trajectories of various cardiovascular risk factors during late adolescence via health behaviors. Individuals from RIGHT Track were re-contacted and invited to participate in adolescent data collection (~16.5, 17.5 and 18(+) years old). Individuals completed assessments of body composition, anthropometric indicators, fitness testing (via peak oxygen consumption), heart rate variability during orthostatic challenge, 7-day accelerometry for physical activity and sleep, 24-h dietary recalls, and blood analysis for biomarkers related to metabolic syndrome, inflammatory status and various hormones and cytokines. Individuals also completed extensive self

Rationale, design and methods for the RIGHT Track Health Study: pathways from childhood self-regulation to cardiovascular risk in adolescence

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Laurie Wideman

2016-06-01

Full Text Available Abstract Background Cardiovascular risk factors during adolescence—including obesity, elevated lipids, altered glucose metabolism, hypertension, and elevated low-grade inflammation—is cause for serious concern and potentially impacts subsequent morbidity and mortality. Despite the importance of these cardiovascular risk factors, very little is known about their developmental origins in childhood. In addition, since adolescence is a time when individuals are navigating major life changes and gaining increasing autonomy from their parents or parental figures, it is a period when control over their own health behaviors (e.g. drug use, sleep, nutrition also increases. The primary aim of this paper is to describe the rationale, design and methods for the RIGHT Track Health Study. This study examines self-regulation as a key factor in the development of cardiovascular risk, and further explores health behaviors as an explanatory mechanism of this association. We also examine potential moderators (e.g. psychosocial adversities such as harsh parenting of this association. Method/design RIGHT Track is a longitudinal study that investigates social and emotional development. The RIGHT Track Health Study prospectively follows participants from age 2 through young adulthood in an effort to understand how self-regulatory behavior throughout childhood alters the trajectories of various cardiovascular risk factors during late adolescence via health behaviors. Individuals from RIGHT Track were re-contacted and invited to participate in adolescent data collection (~16.5, 17.5 and 18+ years old. Individuals completed assessments of body composition, anthropometric indicators, fitness testing (via peak oxygen consumption, heart rate variability during orthostatic challenge, 7-day accelerometry for physical activity and sleep, 24-h dietary recalls, and blood analysis for biomarkers related to metabolic syndrome, inflammatory status and various hormones and

Comparing the Effectiveness of a Clinical Registry and a Clinical Data Warehouse for Supporting Clinical Trial Recruitment: A Case Study

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Weng, Chunhua; Bigger, J Thomas; Busacca, Linda; Wilcox, Adam; Getaneh, Asqual

2010-01-01

This paper reports a case study comparing the relative efficiency of using a Diabetes Registry or a Clinical Data Warehouse to recruit participants for a diabetes clinical trial, TECOS. The Clinical Data Warehouse generated higher positive predictive accuracy (31% vs. 6.6%) and higher participant recruitment than the Registry (30 vs. 14 participants) in a shorter time period (59 vs. 74 working days). We identify important factors that increase clinical trial recruitment efficiency and lower cost. PMID:21347102

Problems in clinical assessment of left ventricular peak filling rate with radionuclide ventriculography

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Ishida, Yoshio; Kim, Bong-Ha; Tsuneoka, Yutaka

1987-02-01

With an increased clinical application of early peak diastolic filling rate (PFR) using radionuclide ventriculography, problems of its clinical significance have emerged. The study was designed to answer the following questions: 1) accuracy of PFR measurement, 2) normalization of PFR, and 3) whether PFR may reflect left ventricular relaxation rate (LVRR). In measuring PFR, an elevated framing rate was required, and the optimal rate was 20 msec/F. Second sound heart gating technique proved to be complementary to conventional ECG R wave gating technique in the evaluation of left ventricular diastolic volume curves and mean filling rate associated with changes in the range of R-R interval. PFR which was normalized with end-diastolic volume (EDV) did not necessarily reflect measured PFR because of individual differences of EDV. An experiment on the relationship of mitral valve pressure to blood flow in dogs revealed that PFR was influenced by not only LVRR but also left atrial pressure. These results may raise a question of the rationale for using the measurement of PFR, as well as its technical problems, in the objective evaluation of LVRR. (Namekawa, K.).

A randomised controlled trial of the efficacy of the ABCD Parenting Young Adolescents Program: rationale and methodology

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Burke Kylie

2010-08-01

Full Text Available Abstract Background The transition to adolescence is a time of increased vulnerability for risk taking and poor health, social and academic outcomes. Parents have an important role in protecting their children from these potential harms. While the effectiveness of parenting programs in reducing problem behavior has been demonstrated, it is not known if parenting programs that target families prior to the onset of significant behavioral difficulties in early adolescence (9-14 years improve the wellbeing of adolescents and their parents. This paper describes the rationale and methodology of a randomised controlled trial testing the efficacy of a parenting program for the promotion of factors known to be associated with positive adolescent outcomes, such as positive parenting practices, parent-adolescent relationships and adolescent behavior. Methods/Design One hundred and eighty parents were randomly allocated to an intervention or wait list control group. Parents in the intervention group participated in the ABCD Parenting Young Adolescents Program, a 6-session behavioral family intervention program which also incorporates acceptance-based strategies. Participants in the Wait List control group did not receive the intervention during a six month waiting period. The study was designed to comply with recommendations of the CONSORT statement. The primary outcome measures were reduction in parent-adolescent conflict and improvements in parent-adolescent relationships. Secondary outcomes included improvements in parent psychosocial wellbeing, parenting self-efficacy and perceived effectiveness, parent-adolescent communication and adolescent behavior. Conclusions Despite the effectiveness of parenting programs in reducing child behavioral difficulties, very few parenting programs for preventing problems in adolescents have been described in the peer reviewed literature. This study will provide data which can be used to examine the efficacy of a

Clinical indications and perceived effectiveness of complementary and alternative medicine in departments of obstetrics in Germany: a questionnaire study.

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Münstedt, Karsten; Brenken, Anja; Kalder, Matthias

2009-09-01

Our earlier study on complementary and alternative medicine (CAM) methods showed that acupuncture, homeopathy, and aromatherapy are available in most obstetrics departments in Germany but it did not evaluate the clinical indications for using CAM. The present study aimed to explore further the effectiveness of CAM use in obstetrics. We sent all departments of obstetrics in North Rhine-Westphalia a questionnaire designed to delineate their use of acupuncture, homeopathy, and aromatherapy during childbirth. It sought details on who provided the CAM therapy (midwife or physician). We asked respondents to indicate on a five-point scale how reasonable or otherwise they would consider the provision of CAM in each of six common problem situations and to estimate for each the proportion of patients given the CAM treatment. Respondents were also asked about the rationale for offering CAM, quality assurance and side effects. Spearman's bivariate correlation, cross-tabulation and Pearson's chi(2) test were used for statistical analysis. About 73.4% (138/187) of the departments responded. Acupuncture and homoeopathy were most widely used. Although obstetricians are responsible for patient care, decisions to provide CAM were largely taken by midwives, and the midwives' belief in the methods' effectiveness and patient demand were the principle motivating factors. Rates of CAM use in the six problem scenarios evaluated were directly related to practitioners' perceptions of the methods' therapeutic effectiveness. CAM methods were widely offered despite the lack of evidence of effectiveness or information on adverse consequences. In Germany, including CAM in the mandatory national quality assurance measures and perinatal surveys would provide valuable information; CAM use elsewhere merits further study.

Recruitment of racial and ethnic minorities to clinical trials conducted within specialty clinics: an intervention mapping approach.

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Amorrortu, Rossybelle P; Arevalo, Mariana; Vernon, Sally W; Mainous, Arch G; Diaz, Vanessa; McKee, M Diane; Ford, Marvella E; Tilley, Barbara C

2018-02-17

Despite efforts to increase diversity in clinical trials, racial/ethnic minority groups generally remain underrepresented, limiting researchers' ability to test the efficacy and safety of new interventions across diverse populations. We describe the use of a systematic framework, intervention mapping (IM), to develop an intervention to modify recruitment behaviors of coordinators and specialist investigators with the goal of increasing diversity in trials conducted within specialty clinics. To our knowledge IM has not been used in this setting. The IM framework was used to ensure that the intervention components were guided by health behavior theories and the evidence. The IM steps consisted of (1) conducting a needs assessment, (2) identification of determinants and objectives, (3) selection of theory-informed methods and practical applications, (4) development and creation of program components, (5) development of an adoption and implementation plan, and (6) creation of an evaluation plan. The intervention included five educational modules, one in-person and four web-based, plus technical assistance calls to coordinators. Modules addressed the intervention rationale, development of clinic-specific plans to obtain minority-serving physician referrals, physician-centered and patient-centered communication, and patient navigation. The evaluation, a randomized trial, was recently completed in 50 specialty clinics and is under analysis. Using IM we developed a recruitment intervention that focused on building relationships with minority-serving physicians to encourage minority patient referrals. IM enhanced our understanding of factors that may influence minority recruitment and helped us integrate strategies from multiple disciplines that were relevant for our audience.

Large Deployable Reflector (LDR) feasibility study update

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Alff, W. H.; Banderman, L. W.

1983-01-01

In 1982 a workshop was held to refine the science rationale for large deployable reflectors (LDR) and develop technology requirements that support the science rationale. At the end of the workshop, a set of LDR consensus systems requirements was established. The subject study was undertaken to update the initial LDR study using the new systems requirements. The study included mirror materials selection and configuration, thermal analysis, structural concept definition and analysis, dynamic control analysis and recommendations for further study. The primary emphasis was on the dynamic controls requirements and the sophistication of the controls system needed to meet LDR performance goals.

Study Design and Rationale for the Phase 3 Clinical Development Program of Enobosarm, a Selective Androgen Receptor Modulator, for the Prevention and Treatment of Muscle Wasting in Cancer Patients (POWER Trials).

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Crawford, Jeffrey; Prado, Carla M M; Johnston, Mary Ann; Gralla, Richard J; Taylor, Ryan P; Hancock, Michael L; Dalton, James T

2016-06-01

subject must have ≥10 % improvement in physical function compared to baseline. To meet the definition of response on LBM, a subject must have demonstrated no loss of LBM compared with baseline. Secondary endpoints include durability of response assessed at day 147 in those responding at day 84. A combined overall survival analysis for both studies is considered a key secondary safety endpoint. The POWER trials design was established with extensive clinical input and collaboration with regulatory agencies. The efficacy endpoints are a result of this feedback and discussion of the threshold for clinical benefit in patients at risk for muscle wasting. Full results from these studies will soon be published and will further guide the development of future anabolic trials. Clinical Trial ID: NCT01355484. https://clinicaltrials.gov/ct2/show/NCT01355484 , NCT01355497. https://clinicaltrials.gov/ct2/show/NCT01355497?term=g300505&rank=1 .

From European Identity and Media Imperialism to Public Diplomacy: The Changing Rationale Behind Euronews

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Eva Polonska-Kimunguyi

2012-11-01

Full Text Available Euronews can be regarded as Europe’s most experimental and successful pan-national broadcaster. It is increasingly international in its organisation and output. The issues covered no longer concentrate on Europe. ‘Going global’ is the channel’s new motto. This paper outlines the changing rationale behind the creation of Euronews. It starts by discussing the American cultural imperialism of the 1970s and 1980s and the way it ignited European responses and counter-measures. It subsequently examines the politics of pan-national identity building in Europe and media’s role in the process. Finally, it demonstrates how Euronews has transformed itself into an instrument of the European Union’s transnational public diplomacy.

Rationale and design of A Trial of Sertraline vs. Cognitive Behavioral Therapy for End-stage Renal Disease Patients with Depression (ASCEND).

Science.gov (United States)

Hedayati, S Susan; Daniel, Divya M; Cohen, Scott; Comstock, Bryan; Cukor, Daniel; Diaz-Linhart, Yaminette; Dember, Laura M; Dubovsky, Amelia; Greene, Tom; Grote, Nancy; Heagerty, Patrick; Katon, Wayne; Kimmel, Paul L; Kutner, Nancy; Linke, Lori; Quinn, Davin; Rue, Tessa; Trivedi, Madhukar H; Unruh, Mark; Weisbord, Steven; Young, Bessie A; Mehrotra, Rajnish

2016-03-01

Major Depressive Disorder (MDD) is highly prevalent in patients with End Stage Renal Disease (ESRD) treated with maintenance hemodialysis (HD). Despite the high prevalence and robust data demonstrating an independent association between depression and poor clinical and patient-reported outcomes, MDD is under-treated when identified in such patients. This may in part be due to the paucity of evidence confirming the safety and efficacy of treatments for depression in this population. It is also unclear whether HD patients are interested in receiving treatment for depression. ASCEND (Clinical Trials Identifier Number NCT02358343), A Trial of Sertraline vs. Cognitive Behavioral Therapy (CBT) for End-stage Renal Disease Patients with Depression, was designed as a multi-center, 12-week, open-label, randomized, controlled trial of prevalent HD patients with comorbid MDD or dysthymia. It will compare (1) a single Engagement Interview vs. a control visit for the probability of initiating treatment for comorbid depression in up to 400 patients; and (2) individual chair-side CBT vs. flexible-dose treatment with a selective serotonin reuptake inhibitor, sertraline, for improvement of depressive symptoms in 180 of the up to 400 patients. The evolution of depressive symptoms will also be examined in a prospective longitudinal cohort of 90 HD patients who choose not to be treated for depression. We discuss the rationale and design of ASCEND, the first large-scale randomized controlled trial evaluating efficacy of non-pharmacologic vs. pharmacologic treatment of depression in HD patients for patient-centered outcomes. Published by Elsevier Inc.

Rationale and Design of A Trial of Sertraline vs. Cognitive Behavioral Therapy for End-stage Renal Disease Patients with Depression (ASCEND)

Science.gov (United States)

Hedayati, S. Susan; Daniel, Divya M.; Cohen, Scott; Comstock, Bryan; Cukor, Daniel; Diaz-Linhart, Yaminette; Dember, Laura M.; Dubovsky, Amelia; Greene, Tom; Grote, Nancy; Heagerty, Patrick; Katon, Wayne; Kimmel, Paul L.; Kutner, Nancy; Linke, Lori; Quinn, Davin; Rue, Tessa; Trivedi, Madhukar H.; Unruh, Mark; Weisbord, Steven; Young, Bessie A.; Mehrotra, Rajnish

2015-01-01

Major Depressive Disorder (MDD) is highly prevalent in patients with End Stage Renal Disease (ESRD) treated with maintenance hemodialysis (HD). Despite the high prevalence and robust data demonstrating an independent association between depression and poor clinical and patient-reported outcomes, MDD is under-treated when identified in such patients. This may in part be due to the paucity of evidence confirming the safety and efficacy of treatments for depression in this population. It is also unclear whether HD patients are interested in receiving treatment for depression. ASCEND (Clinical Trials Identifier Number NCT02358343), A Trial of Sertraline vs. Cognitive Behavioral Therapy (CBT) for End-stage Renal Disease Patients with Depression, was designed as a multi-center, 12-week, open-label, randomized, controlled trial of prevalent HD patients with comorbid MDD or dysthymia. It will compare (1) a single Engagement Interview vs. a control visit for the probability of initiating treatment for comorbid depression in up to 400 patients; and (2) individual chair-side CBT vs. flexible-dose treatment with a selective serotonin reuptake inhibitor, sertraline, for improvement of depressive symptoms in 180 of the up to 400 patients. The evolution of depressive symptoms will also be examined in a prospective longitudinal cohort of 90 HD patients who choose not to be treated for depression. We discuss the rationale and design of ASCEND, the first large-scale randomized controlled trial evaluating efficacy of non-pharmacologic vs. pharmacologic treatment of depression in HD patients for patient-centered outcomes. PMID:26621218

Treatment of depression after myocardial infarction and the effects on cardiac prognosis and quality of life: rationale and outline of the Myocardial INfarction and Depression-Intervention Trial (MIND-IT).

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van den Brink, Rob H S; van Melle, Joost P; Honig, Adriaan; Schene, Aart H; Crijns, Harry J G M; Lambert, Frank P G; Ormel, Johan

2002-08-01

Patients with a depressive disorder after myocardial infarction (MI) have a significantly increased risk of major cardiac events. The Myocardial INfarction and Depression-Intervention Trial (MIND-IT) investigates whether antidepressive treatment can improve the cardiac prognosis for these patients. The rationale and outline of the study are described. In this multicenter randomized clinical trial, 2140 patients admitted for MI are screened for depressive symptoms with a questionnaire 0, 3, 6, 9, and 12 months after MI. Patients with symptoms undergo a standardized psychiatric interview. Those with a post-MI depressive episode are randomized to intervention (ie, antidepressive treatment; n = 190) or care-as-usual (CAU; n = 130). In the intervention arm, the research diagnosis is to be confirmed by a psychiatrist. First-choice treatment consists of placebo-controlled treatment with mirtazapine. In case of refusal or nonresponse, alternative open treatment with citalopram is offered. In the CAU arm, the patient is not informed about the research diagnosis. Psychiatric treatment outside the study is recorded, but no treatment is offered. Both arms are followed for end points (cardiac death or hospital admission for MI, unstable angina, heart failure, or ventricular tachyarrhythmia) during an average period of 27 months. Analysis is on an intention-to-treat basis. The MIND-IT study will show whether treatment of post-MI depression can improve cardiac prognosis.

Rationale, design, and preliminary results of the Quebec Warfarin Cohort Study.

Science.gov (United States)

Perreault, Sylvie; Shahabi, Payman; Côté, Robert; Dumas, Stéphanie; Rouleau-Mailloux, Étienne; Feroz Zada, Yassamin; Provost, Sylvie; Mongrain, Ian; Dorais, Marc; Huynh, Thao; Kouz, Simon; Diaz, Ariel; Blostein, Mark; de Denus, Simon; Turgeon, Jacques; Ginsberg, Jeffrey; Lelorier, Jacques; Lalonde, Lyne; Busque, Lambert; Kassis, Jeannine; Talajic, Mario; Tardif, Jean-Claude; Dubé, Marie-Pierre

2018-05-01

Over- and undercoagulation with warfarin are associated with hemorrhagic and thromboembolic events, respectively. Genetic and clinical factors affect warfarin response, and the causes of this variability remain unclear. We present descriptive statistics and test for predictors of poor anticoagulation control. The Quebec Warfarin Cohort (QWC) comprises 1059 new warfarin users, with prospective follow-up using telephone questionnaires every 3 months for 1 year, and using healthcare administrative databases (RAMQ and Med-Echo) for 5 years prior to cohort entry and up to 10 years following active patient participation. Genetic material was collected, and genotyping of CYP2C9 and VKORC1 genes was conducted. Measured outcomes included the percentage of time patients spent within therapeutic range, anticoagulation control, warfarin dose, bleeding, and thromboembolic events. We report baseline characteristics and outcomes after 1 year of follow-up. Poor anticoagulation control was defined as time in therapeutic range <60% in the 3- to 12-month interval. Participants had a mean age of 71 years, and 62% were men. The most common indication for warfarin was atrial fibrillation (87%). Mean time in therapeutic range was 56% (±25%) in the 3 months following warfarin initiation, and 70% (±21%) in the 3- to 12-month interval. During follow-up, the rate of stroke or systemic embolism was 1.8 events per 100 person-years; for major bleeding events, 3.3 events per 100 person-years. Independent predictors of poor anticoagulation control were chronic kidney disease, heart failure, dyslipidemia, and age. The QWC represents a good research cohort to investigate clinical and genetic factors in a warfarin-anticoagulated population. © 2018 Wiley Periodicals, Inc.

Marketing and clinical trials: a case study

Directory of Open Access Journals (Sweden)

Entwistle Vikki A

2007-11-01

Full Text Available Abstract Background Publicly funded clinical trials require a substantial commitment of time and money. To ensure that sufficient numbers of patients are recruited it is essential that they address important questions in a rigorous manner and are managed well, adopting effective marketing strategies. Methods Using methods of analysis drawn from management studies, this paper presents a structured assessment framework or reference model, derived from a case analysis of the MRC's CRASH trial, of 12 factors that may affect the success of the marketing and sales activities associated with clinical trials. Results The case study demonstrates that trials need various categories of people to buy in – hence, to be successful, trialists must embrace marketing strategies to some extent. Conclusion The performance of future clinical trials could be enhanced if trialists routinely considered these factors.

Balancing high accrual and ethical recruitment in paediatric oncology: a qualitative study of the 'look and feel' of clinical trial discussions

Directory of Open Access Journals (Sweden)

Eden Tim OB

2010-10-01

Full Text Available Abstract Background High accrual to clinical trials enables new treatment strategies to be tested rapidly, accurately and with generalisability. Ethical standards also must be high so that participation is voluntary and informed. However, this can be difficult to achieve in trials with complex designs and in those which are closely embedded in clinical practice. Optimal recruitment requires a balance of both ethical and accrual considerations. In the context of a trial of stratified treatments for children with acute lymphoblastic leukaemia (UKALL2003 we examined how recruitment looked to an observer and how it felt to the parents, to identify how doctors' communication could promote or inhibit optimal recruitment. Methods We audio-recorded, transcribed and analysed routine doctor-patient consultations (n = 20 and interviews between researchers and parents (n = 30 parents across six UK treatment centres. Analysis was informed by the constant comparative method. For consultation transcripts, analysis focussed on how doctors presented the trial. We compared this with analysis of the interview transcripts which focussed on parents' perceptions and understanding of the trial. Results Parents and doctors discussed the trial in most consultations, even those that did not involve a decision about randomisation. Doctors used language allying them both with the trial and with the parent, indicating that they were both an 'investigator' and a 'clinician'. They presented the trial both as an empirical study with a scientific imperative and also as offering personalisation of treatment for the child. Parents appeared to understand that trial involvement was voluntary, that it was different from routine care and that they could withdraw from the trial at any time. Some were confused about the significance of the MRD test and the personalisation of treatment. Conclusions Doctors communicated in ways that generally promoted optimal recruitment, indicating that

Computers and clinical arrhythmias.

Science.gov (United States)

Knoebel, S B; Lovelace, D E

1983-02-01

Cardiac arrhythmias are ubiquitous in normal and abnormal hearts. These disorders may be life-threatening or benign, symptomatic or unrecognized. Arrhythmias may be the precursor of sudden death, a cause or effect of cardiac failure, a clinical reflection of acute or chronic disorders, or a manifestation of extracardiac conditions. Progress is being made toward unraveling the diagnostic and therapeutic problems involved in arrhythmogenesis. Many of the advances would not be possible, however, without the availability of computer technology. To preserve the proper balance and purposeful progression of computer usage, engineers and physicians have been exhorted not to work independently in this field. Both should learn some of the other's trade. The two disciplines need to come together to solve important problems with computers in cardiology. The intent of this article was to acquaint the practicing cardiologist with some of the extant and envisioned computer applications and some of the problems with both. We conclude that computer-based database management systems are necessary for sorting out the clinical factors of relevance for arrhythmogenesis, but computer database management systems are beset with problems that will require sophisticated solutions. The technology for detecting arrhythmias on routine electrocardiograms is quite good but human over-reading is still required, and the rationale for computer application in this setting is questionable. Systems for qualitative, continuous monitoring and review of extended time ECG recordings are adequate with proper noise rejection algorithms and editing capabilities. The systems are limited presently for clinical application to the recognition of ectopic rhythms and significant pauses. Attention should now be turned to the clinical goals for detection and quantification of arrhythmias. We should be asking the following questions: How quantitative do systems need to be? Are computers required for the detection of

Patient attitudes about the clinical use of placebo: qualitative perspectives from a telephone survey.

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Ortiz, Robin; Chandros Hull, Sara; Colloca, Luana

2016-04-04

To examine qualitative responses regarding the use of placebo treatments in medical care in a sample of US patients.Survey studies suggest a deliberate clinical use of placebos by physicians, and prior research has found that although most US patients find placebo use acceptable, the rationale for these beliefs is largely unknown. Members of the Outpatient Clinic at the Kaiser Permanente Northern California interviewed research participants who had been seen for a chronic health problem at least once in the prior 6 months. 853 women (61%) and men, white (58%) and non-white participants aged 18-75 years. Qualitative responses on perceptions of placebo use from one-time telephone surveys were analysed for common themes and associations with demographic variables. Prior results indicated that a majority of respondents felt it acceptable for doctors to recommend placebo treatments. Our study found that a lack of harm (n=291, 46.1%) and potential benefit (n=250, 39.6%) were the most common themes to justify acceptability of placebo use. Responses citing potential benefit were associated with higher education (r=0.787; pright to know and power of the mind. Older age was associated with likelihood to cite overall physician, as opposed to treatment, related themes (r=0.753; prights-and-licensing/

The evaluation of subcutaneous proleukin (interleukin-2) in a randomized international trial: rationale, design, and methods of ESPRIT.

Science.gov (United States)

Emery, Sean; Abrams, Donald I; Cooper, David A; Darbyshire, Janet H; Lane, H Clifford; Lundgren, Jens D; Neaton, James D

2002-04-01

The Evaluation of Subcutaneous Proleukin in a Randomized International Trial (ESPRIT) is a large ongoing randomized trial of subcutaneous interleukin-2 (IL-2) plus antiretroviral therapy versus antiretroviral therapy alone in patients with HIV (human immunodeficiency virus) disease and CD4 cell counts of at least 300 cells/mm(3). The primary objective is to determine whether the addition of IL-2 to combination antiretroviral therapy improves morbidity and mortality. The aim is to recruit 4000 participants and follow them for an average of 5 years. Eligible subjects will be recruited at 275 investigational sites in 23 countries around the world. Coupled with broad eligibility criteria this will ensure widely applicable results. A range of secondary objectives will also be addressed in this setting that will include the conduct of observational studies and nested substudies with a public health focus. This article describes the rationale supporting the trial in addition to reviewing the study design, coordination, and governance.

The background and rationale for a new fixed-dose combination for first-line treatment of tuberculosis in children.

Science.gov (United States)

Graham, S M; Grzemska, M; Gie, R P

2015-12-01

In 2010, the World Health Organization revised the recommendations for the treatment of tuberculosis (TB) in children. The major revision was to increase isoniazid, rifampicin and pyrazinamide dosages according to body weight in children. The recommendations for higher dosages are based on consistent evidence from 1) pharmacokinetic studies suggesting that young children require higher dosages than adolescents and adults to achieve desired serum concentrations; and 2) observational studies reporting that the higher dosages would not be associated with increased risk of toxicity in children. However, national tuberculosis programmes faced unforeseen challenges in implementing the revised recommendations. The main difficulty was to adapt the revised dosages for the treatment of children with drug-susceptible TB using available fixed-dose combinations (FDCs). A more suitable FDC for the intensive and continuation phases of treatment has now been developed for planned implementation in 2015. This paper explains the background and rationale for the development of a new FDC tablet for children with drug-susceptible TB.

ACCISS study rationale and design: activating collaborative cancer information service support for cervical cancer screening

Directory of Open Access Journals (Sweden)

Bullard Emily

2009-12-01

Full Text Available Abstract Background High-quality cancer information resources are available but underutilized by the public. Despite greater awareness of the National Cancer Institute's Cancer Information Service among low-income African Americans and Hispanics compared with Caucasians, actual Cancer Information Service usage is lower than expected, paralleling excess cancer-related morbidity and mortality for these subgroups. The proposed research examines how to connect the Cancer Information Service to low-income African-American and Hispanic women and their health care providers. The study will examine whether targeted physician mailing to women scheduled for colposcopy to follow up an abnormal Pap test can increase calls to the Cancer Information Service, enhance appropriate medical follow-up, and improve satisfaction with provider-patient communication. Methods/Design The study will be conducted in two clinics in ethnically diverse low-income communities in Chicago. During the formative phase, patients and providers will provide input regarding materials planned for use in the experimental phase of the study. The experimental phase will use a two-group prospective randomized controlled trial design. African American and Hispanic women with an abnormal Pap test will be randomized to Usual Care (routine colposcopy reminder letter or Intervention (reminder plus provider recommendation to call the Cancer Information Service and sample questions to ask. Primary outcomes will be: 1 calls to the Cancer Information Service; 2 timely medical follow-up, operationalized by whether the patient keeps her colposcopy appointment within six months of the abnormal Pap; and 3 patient satisfaction with provider-patient communication at follow-up. Discussion The study examines the effectiveness of a feasible, sustainable, and culturally sensitive strategy to increase awareness and use of the Cancer Information Service among an underserved population. The goal of linking a

Rationale, design, and implementation protocol of an electronic health record integrated clinical prediction rule (iCPR randomized trial in primary care

Directory of Open Access Journals (Sweden)

Wisnivesky Juan

2011-09-01

Full Text Available Abstract Background Clinical prediction rules (CPRs represent well-validated but underutilized evidence-based medicine tools at the point-of-care. To date, an inability to integrate these rules into an electronic health record (EHR has been a major limitation and we are not aware of a study demonstrating the use of CPR's in an ambulatory EHR setting. The integrated clinical prediction rule (iCPR trial integrates two CPR's in an EHR and assesses both the usability and the effect on evidence-based practice in the primary care setting. Methods A multi-disciplinary design team was assembled to develop a prototype iCPR for validated streptococcal pharyngitis and bacterial pneumonia CPRs. The iCPR tool was built as an active Clinical Decision Support (CDS tool that can be triggered by user action during typical workflow. Using the EHR CDS toolkit, the iCPR risk score calculator was linked to tailored ordered sets, documentation, and patient instructions. The team subsequently conducted two levels of 'real world' usability testing with eight providers per group. Usability data were used to refine and create a production tool. Participating primary care providers (n = 149 were randomized and intervention providers were trained in the use of the new iCPR tool. Rates of iCPR tool triggering in the intervention and control (simulated groups are monitored and subsequent use of the various components of the iCPR tool among intervention encounters is also tracked. The primary outcome is the difference in antibiotic prescribing rates (strep and pneumonia iCPR's encounters and chest x-rays (pneumonia iCPR only between intervention and control providers. Discussion Using iterative usability testing and development paired with provider training, the iCPR CDS tool leverages user-centered design principles to overcome pervasive underutilization of EBM and support evidence-based practice at the point-of-care. The ongoing trial will determine if this collaborative

How valid are claims for synergy in published clinical studies?

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Ocana, A; Amir, E; Yeung, C; Seruga, B; Tannock, I F

2012-08-01

Clinical trials evaluating drug combinations are often stimulated by claims of synergistic interactions in preclinical models. Overuse or misuse of the term synergy could lead to poorly designed clinical studies. We searched PubMed using the terms 'synergy' or 'synergistic' and 'cancer' to select articles published between 2006 and 2010. Eligible studies were those that referred to synergy in preclinical studies to justify a drug combination evaluated in a clinical trial. Eighty-six clinical articles met eligibility criteria and 132 preclinical articles were cited in them. Most of the clinical studies were phase I (43%) or phase II trials (56%). Appropriate methods to evaluate synergy in preclinical studies included isobologram analysis in 18 studies (13.6%) and median effect in 10 studies (7.6%). Only 26 studies using animal models (39%) attempted to evaluate therapeutic index. There was no association between the result of the clinical trial and the use of an appropriate method to evaluate synergy (P=0.25, chi-squared test). Synergy is cited frequently in phase I and phase II studies to justify the evaluation of a specific drug combination. Inappropriate methods for evaluation of synergy and poor assessment of therapeutic index have been used in most preclinical articles.

Clinical Pharmacology Studies in Critically Ill Children

Science.gov (United States)

Thakkar, Nilay; Salerno, Sara; Hornik, Christoph P.; Gonzalez, Daniel

2016-01-01

Developmental and physiological changes in children contribute to variation in drug disposition with age. Additionally, critically ill children suffer from various life-threatening conditions that can lead to pathophysiological alterations that further affect pharmacokinetics (PK). Some factors that can alter PK in this patient population include variability in tissue distribution caused by protein binding changes and fluid shifts, altered drug elimination due to organ dysfunction, and use of medical interventions that can affect drug disposition (e.g., extracorporeal membrane oxygenation and continuous renal replacement therapy). Performing clinical studies in critically ill children is challenging because there is large inter-subject variability in the severity and time course of organ dysfunction; some critical illnesses are rare, which can affect subject enrollment; and critically ill children usually have multiple organ failure, necessitating careful selection of a study design. As a result, drug dosing in critically ill children is often based on extrapolations from adults or non-critically ill children. Dedicated clinical studies in critically ill children are urgently needed to identify optimal dosing of drugs in this population. This review will summarize the effect of critical illness on pediatric PK, the challenges associated with performing studies in this vulnerable subpopulation, and the clinical PK studies performed to date for commonly used drugs. PMID:27585904

Acute radiation proctitis. A clinical, histopathological and histochemical study

International Nuclear Information System (INIS)

Hovdenak, Nils

2004-01-01

The aim of the study is: 1) A sequential description of the clinical course of acute radiation proctitis during pelvic RT. 2) A sequential description of the rectal mucosal histopathology during pelvic RT as a possible substrate for clinical toxicity. 3) To assess the mucosal protease activity during RT as a possible explanation of the observed tissue changes. 4) To assess the efficacy of prophylactic sucralfate in acute radiation proctitis a randomised study was initiated and carried out together with a meta-analysis of previously available data. 5) Most studies on clinical acute toxicity in pelvic RT use either the RTOG/EORTC score system or focus on diarrhoea/stool frequency. A more differentiated and sensitive recording was developed and tested to pick up symptoms escaping the commonly used scores. 6) Study the relation between histopathological findings and the clinical picture. 4 papers presenting various studies are included. The titles are: 1) Acute radiation proctitis: a sequential clinicopathologic study during pelvic radiotherapy. 2) Clinical significance of increased gelatinolytic activity in the rectal mucosa during external beam radiation therapy of prostate cancer. 3) Profiles and time course of acute radiation toxicity symptoms during conformal radiotherapy for cancer of the prostate. 4) Sucralfate does not ameliorate acute radiation proctitis. Some future prospects are discussed

Acute radiation proctitis. A clinical, histopathological and histochemical study

Energy Technology Data Exchange (ETDEWEB)

Hovdenak, Nils

2004-07-01

The aim of the study is: 1) A sequential description of the clinical course of acute radiation proctitis during pelvic RT. 2) A sequential description of the rectal mucosal histopathology during pelvic RT as a possible substrate for clinical toxicity. 3) To assess the mucosal protease activity during RT as a possible explanation of the observed tissue changes. 4) To assess the efficacy of prophylactic sucralfate in acute radiation proctitis a randomised study was initiated and carried out together with a meta-analysis of previously available data. 5) Most studies on clinical acute toxicity in pelvic RT use either the RTOG/EORTC score system or focus on diarrhoea/stool frequency. A more differentiated and sensitive recording was developed and tested to pick up symptoms escaping the commonly used scores. 6) Study the relation between histopathological findings and the clinical picture. 4 papers presenting various studies are included. The titles are: 1) Acute radiation proctitis: a sequential clinicopathologic study during pelvic radiotherapy. 2) Clinical significance of increased gelatinolytic activity in the rectal mucosa during external beam radiation therapy of prostate cancer. 3) Profiles and time course of acute radiation toxicity symptoms during conformal radiotherapy for cancer of the prostate. 4) Sucralfate does not ameliorate acute radiation proctitis. Some future prospects are discussed.

Maxillary advancement for mandibular prognathism: indications and rationale.

Science.gov (United States)

Rosen, H M

1991-05-01

The surgical correction of mandibular prognathism has traditionally involved posterior repositioning of the mandibular body. This treatment approach corrects the skeletal disproportion at the expense of reducing facial skeletal volume and can unpredictably result in inadequately supported soft tissues with loss of skeletal definition. In an effort to avoid these sequelae of mandibular reduction, 18 patients diagnosed as having mandibular prognathism were treated with maxillary advancement surgery at the Le Fort I level. Mean patient SNB angle was 85.2 degrees, as compared with a normal 79 +/- 3 degrees. Maxillae were documented to be in normal position relative to both cranial base and Frankfort horizontal. The mean maxillary advancement was 6.9 mm, with a range of 4.5 to 8.8 mm. All patients required genioplasty to reduce vertical chin height and/or to laterally shift the chin. At the time of follow-up (mean 16.2 months), all patients retained cephalometric data suggestive of enlarged mandibles and excessive anterior facial divergence. However, maxillomandibular harmony and facial convexity had been restored without sacrificing skeletal volume. Treatment results demonstrated these faces to be skeletally well proportioned despite lower face protrusion that was beyond "normal." Postoperative appearances were characterized by a well-supported soft-tissue envelope and a highlighted skeletal foundation, creating angular, well-defined lower faces. These findings support the credibility of maxillary advancement as the procedure of choice in selected individuals with mandibular prognathism. Indications and an aesthetic rationale for this surgical approach are presented.

Rationale for the Design of a Web-based Programming Course for Adults

DEFF Research Database (Denmark)

Bennedsen, Jens; Caspersen, Michael Edelgaard

2003-01-01

Web-based distance education is becoming more and more popular in particular for part-time educations primarily because it flexibly adapts to a busy life where family and work has first priority. Students can follow the course without wasting precious time traveling to and from campus several...... evenings a week, and participation can take place also in situations where it would otherwise be impossible (e.g. a sick child or a business trip). However, these advantages don't come for free: the students lose the social relations following from face-to-face contact with the lecturer and teaching...... assistant as well as the other students. Another serious drawback is the reduced bandwidth in communication among the different actors. Precautions have to be taken in order to compensate for these and other drawbacks. We describe a web-based introductory programming course for adults and the rationale...

Data Linkage from Clinical to Study Databases via an R Data Warehouse User Interface. Experiences from a Large Clinical Follow-up Study.

Science.gov (United States)

Kaspar, Mathias; Ertl, Maximilian; Fette, Georg; Dietrich, Georg; Toepfer, Martin; Angermann, Christiane; Störk, Stefan; Puppe, Frank

2016-08-05

Data that needs to be documented for clinical studies has often been acquired and documented in clinical routine. Usually this data is manually transferred to Case Report Forms (CRF) and/or directly into an electronic data capture (EDC) system. To enhance the documentation process of a large clinical follow-up study targeting patients admitted for acutely decompensated heart failure by accessing the data created during routine and study visits from a hospital information system (HIS) and by transferring it via a data warehouse (DWH) into the study's EDC system. This project is based on the clinical DWH developed at the University of Würzburg. The DWH was extended by several new data domains including data created by the study team itself. An R user interface was developed for the DWH that allows to access its source data in all its detail, to transform data as comprehensively as possible by R into study-specific variables and to support the creation of data and catalog tables. A data flow was established that starts with labeling patients as study patients within the HIS and proceeds with updating the DWH with this label and further data domains at a daily rate. Several study-specific variables were defined using the implemented R user interface of the DWH. This system was then used to export these variables as data tables ready for import into our EDC system. The data tables were then used to initialize the first 296 patients within the EDC system by pseudonym, visit and data values. Afterwards, these records were filled with clinical data on heart failure, vital parameters and time spent on selected wards. This solution focuses on the comprehensive access and transformation of data for a DWH-EDC system linkage. Using this system in a large clinical study has demonstrated the feasibility of this approach for a study with a complex visit schedule.

Prevalence and correlates of treatment failure among Kenyan children hospitalised with severe community-acquired pneumonia: a prospective study of the clinical effectiveness of WHO pneumonia case management guidelines.

Science.gov (United States)

Agweyu, Ambrose; Kibore, Minnie; Digolo, Lina; Kosgei, Caroline; Maina, Virginia; Mugane, Samson; Muma, Sarah; Wachira, John; Waiyego, Mary; Maleche-Obimbo, Elizabeth

2014-11-01

To determine the extent and pattern of treatment failure (TF) among children hospitalised with community-acquired pneumonia at a large tertiary hospital in Kenya. We followed up children aged 2-59 months with WHO-defined severe pneumonia (SP) and very severe pneumonia (VSP) for up to 5 days for TF using two definitions: (i) documentation of pre-defined clinical signs resulting in change of treatment (ii) primary clinician's decision to change treatment with or without documentation of the same pre-defined clinical signs. We enrolled 385 children. The risk of TF varied between 1.8% (95% CI 0.4-5.1) and 12.4% (95% CI 7.9-18.4) for SP and 21.4% (95% CI 15.9-27) and 39.3% (95% CI 32.5-46.4) for VSP depending on the definition applied. Higher rates were associated with early changes in therapy by clinician in the absence of an obvious clinical rationale. Non-adherence to treatment guidelines was observed for 70/169 (41.4%) and 67/201 (33.3%) of children with SP and VSP, respectively. Among children with SP, adherence to treatment guidelines was associated with the presence of wheeze on initial assessment (P = 0.02), while clinician non-adherence to guideline-recommended treatments for VSP tended to occur in children with altered consciousness (P < 0.001). Using propensity score matching to account for imbalance in the distribution of baseline clinical characteristics among children with VSP revealed no difference in TF between those treated with the guideline-recommended regimen vs. more costly broad-spectrum alternatives [risk difference 0.37 (95% CI -0.84 to 0.51)]. Before revising current pneumonia case management guidelines, standardised definitions of TF and appropriate studies of treatment effectiveness of alternative regimens are required. © 2014 The Authors. Tropical Medicine & International Health published by John Wiley & Sons Ltd.

Ethics of clinical science in a public health emergency: drug discovery at the bedside.

Science.gov (United States)

Edwards, Sarah J L

2013-01-01

Clinical research under the usual regulatory constraints may be difficult or even impossible in a public health emergency. Regulators must seek to strike a good balance in granting as wide therapeutic access to new drugs as possible at the same time as gathering sound evidence of safety and effectiveness. To inform current policy, I reexamine the philosophical rationale for restricting new medicines to clinical trials, at any stage and for any population of patients (which resides in the precautionary principle), to show that its objective to protect public health, now or in the future, could soon be defeated in a pandemic. Providing wider therapeutic access and coordinating observations and natural experiments, including service delivery by cluster (wedged cluster trials), may provide such a balance. However, there are important questions of fairness to resolve before any such research can proceed.

Prospective Clinical Study of Precision Oncology in Solid Tumors.

Science.gov (United States)

Sohal, Davendra P S; Rini, Brian I; Khorana, Alok A; Dreicer, Robert; Abraham, Jame; Procop, Gary W; Saunthararajah, Yogen; Pennell, Nathan A; Stevenson, James P; Pelley, Robert; Estfan, Bassam; Shepard, Dale; Funchain, Pauline; Elson, Paul; Adelstein, David J; Bolwell, Brian J

2015-11-09

Systematic studies evaluating clinical benefit of tumor genomic profiling are lacking. We conducted a prospective study in 250 patients with select solid tumors at the Cleveland Clinic. Eligibility required histopathologic diagnosis, age of 18 years or older, Eastern Cooperative Oncology Group performance status 0-2, and written informed consent. Tumors were sequenced using FoundationOne (Cambridge, MA). Results were reviewed at the Cleveland Clinic Genomics Tumor Board. Outcomes included feasibility and clinical impact. Colorectal (25%), breast (18%), lung (13%), and pancreatobiliary (13%) cancers were the most common diagnoses. Median time from consent to result was 25 days (range = 3-140). Of 223 evaluable samples, 49% (n = 109) of patients were recommended a specific therapy, but only 11% (n = 24) received such therapy: 12 on clinical trials, nine off-label, three on-label. Lack of clinical trial access (n = 49) and clinical deterioration (n = 29) were the most common reasons for nonrecommendation/nonreceipt of genomics-driven therapy. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Proposed food and drug administration protection action guides for human food and animal feed: Rationale and limits

International Nuclear Information System (INIS)

Shleien, B.; Schmidt, G.D.; Chiacchierini, R.P.

1978-01-01

The Food and Drug Administration is proposing Protective Action Guides (PAG's) to be used in the event that a radiological incident results in the radioactive contamination of human food and animal feed. PAG's are proposed for two levels of response: (1) PREVENTIVE PAG - establishes a level at which responsible officials should take protective action to prevent or reduce the concentration of radioactivity in food or animal feed. (2) EMERGENCY PAG - establishes a level at which responsible officials should isolate food containing radioactivity to prevent its introduction into commerce and determine whether condemnation or another disposition is appropriate. Derived response levels, which are defined as the concentration of radioactivity in food or animal feed corresponding to the above PAG's, are proposed for radionuclides of most significance. The presentation will discuss the supporting rationale as well as the numerical limits for the PAG's. This rationale is based on the process of risk assessment and cost-benefit and cost-effectiveness analysis. The risk assessment compares the risk of radiation exposure to the risk from prevalent hazards accepted by society and from variability of the natural radiation environment. The cost-benefit analysis is limited to protective actions efficacious in the reduction of iodine-131 dose to the thyroid via the milk pathway (condemnation and use of stored feed). In addition, the metabolic and agricultural transfer models that were used to calculate derived response levels will be described briefly. (author)

Proposed food and drug administration protection action guides for human food and animal feed: Rationale and limits

Energy Technology Data Exchange (ETDEWEB)

Shleien, B; Schmidt, G D; Chiacchierini, R P [Food and Drug Administration, Bureau of Radiological Health, Rockville, MD (United States)

1978-12-01

The Food and Drug Administration is proposing Protective Action Guides (PAG's) to be used in the event that a radiological incident results in the radioactive contamination of human food and animal feed. PAG's are proposed for two levels of response: (1) PREVENTIVE PAG - establishes a level at which responsible officials should take protective action to prevent or reduce the concentration of radioactivity in food or animal feed. (2) EMERGENCY PAG - establishes a level at which responsible officials should isolate food containing radioactivity to prevent its introduction into commerce and determine whether condemnation or another disposition is appropriate. Derived response levels, which are defined as the concentration of radioactivity in food or animal feed corresponding to the above PAG's, are proposed for radionuclides of most significance. The presentation will discuss the supporting rationale as well as the numerical limits for the PAG's. This rationale is based on the process of risk assessment and cost-benefit and cost-effectiveness analysis. The risk assessment compares the risk of radiation exposure to the risk from prevalent hazards accepted by society and from variability of the natural radiation environment. The cost-benefit analysis is limited to protective actions efficacious in the reduction of iodine-131 dose to the thyroid via the milk pathway (condemnation and use of stored feed). In addition, the metabolic and agricultural transfer models that were used to calculate derived response levels will be described briefly. (author)

Using Clinical Gait Case Studies to Enhance Learning in Biomechanics

Science.gov (United States)

Chester, Victoria

2011-01-01

Clinical case studies facilitate the development of clinical reasoning strategies through knowledge and integration of the basic sciences. Case studies have been shown to be more effective in developing problem-solving abilities than the traditional lecture format. To enhance the learning experiences of students in biomechanics, clinical case…

Talocalcaneal luxation: an anatomic and clinical study

International Nuclear Information System (INIS)

Gorse, M.J.; Purinton, P.T.; Penwick, R.C.; Aron, D.N.; Roberts, R.E.

1990-01-01

Talocalcaneal luxation in dogs was studied by anatomic dissection of the talocalcaneal joint in cadavers and review of five clinical cases. The integrity of the talocalcaneal joint was maintained by two strong ligaments traversing the tarsal sinus between the two bones. The joint was found to be a low motion joint. Luxation in clinical cases was not always apparent on standard radiographic views. Three dogs were treated surgically with a screw inserted in lag fashion from talus to calcaneus. One luxation was treated surgically with figure-of-eight orthopedic wires and one was treated with external coaptation. Four dogs returned to their previous levels of function without clinically detectable lameness

Patent foramen ovale closure with GORE HELEX or CARDIOFORM Septal Occluder vs. antiplatelet therapy for reduction of recurrent stroke or new brain infarct in patients with prior cryptogenic stroke: Design of the randomized Gore REDUCE Clinical Study.

Science.gov (United States)

Kasner, Scott E; Thomassen, Lars; Søndergaard, Lars; Rhodes, John F; Larsen, Coby C; Jacobson, Joth

2017-12-01

Rationale The utility of patent foramen ovale (PFO) closure for secondary prevention in patients with prior cryptogenic stroke is uncertain despite multiple randomized trials completed to date. Aims The Gore REDUCE Clinical Study (REDUCE) aims to establish superiority of patent foramen ovale closure in conjunction with antiplatelet therapy over antiplatelet therapy alone in reducing the risk of recurrent clinical ischemic stroke or new silent brain infarct in patients who have had a cryptogenic stroke. Methods and design This controlled, open-label trial randomized 664 subjects with cryptogenic stroke at 63 multinational sites in a 2:1 ratio to either antiplatelet therapy plus patent foramen ovale closure (with GORE® HELEX® Septal Occluder or GORE® CARDIOFORM Septal Occluder) or antiplatelet therapy alone. Subjects will be prospectively followed for up to five years. Neuroimaging is required for all subjects at baseline and at two years or study exit. Study outcomes The two co-primary endpoints for the study are freedom from recurrent clinical ischemic stroke through at least 24 months post-randomization and incidence of new brain infarct (defined as clinical ischemic stroke or silent brain infarct) through 24 months. The primary analyses are an unadjusted log-rank test and a binomial test of subject-based proportions, respectively, both on the intent-to-treat population, with adjustment for testing multiplicity. Discussion The REDUCE trial aims to target a patient population with truly cryptogenic strokes. Medical therapy is limited to antiplatelet agents in both arms thereby reducing confounding. The trial should determine whether patent foramen ovale closure with the Gore septal occluders is safe and more effective than medical therapy alone for the prevention of recurrent clinical ischemic stroke or new silent brain infarct; the neuroimaging data will provide an opportunity to further support the proof of concept. The main results are anticipated in 2017

Understanding implementation processes of clinical pathways and clinical practice guidelines in pediatric contexts: a study protocol

Directory of Open Access Journals (Sweden)

Scott Shannon D

2011-12-01

Full Text Available Abstract Background Canada is among the most prosperous nations in the world, yet the health and wellness outcomes of Canadian children are surprisingly poor. There is some evidence to suggest that these poor health outcomes are partly due to clinical practice variation, which can stem from failure to apply the best available research evidence in clinical practice, otherwise known as knowledge translation (KT. Surprisingly, clinical practice variation, even for common acute paediatric conditions, is pervasive. Clinical practice variation results in unnecessary medical treatments, increased suffering, and increased healthcare costs. This study focuses on improving health outcomes for common paediatric acute health concerns by evaluating strategies that improve KT and reduce clinical practice variation. Design/Methods Using a multiple case study design, qualitative and quantitative data will be collected from four emergency departments in western Canada. Data sources will include: pre- and post-implementation focus group data from multidisciplinary healthcare professionals; individual interviews with the local champions, KT intervention providers, and unit/site leaders/managers; Alberta Context Tool (ACT survey data; and aggregated patient outcome data. Qualitative and quantitative data will be systematically triangulated, and matrices will be built to do cross-case comparison. Explanations will be built about the success or lack of success of the clinical practice guidelines (CPG and clinical pathways (CPs uptake based upon the cross-case comparisons. Significance This study will generate new knowledge about the potential causal mechanisms and factors which shape implementation. Future studies will track the impact of the CPG/CPs implementation on children's health outcome, and healthcare costs.

Use of patient-reported outcomes in outpatient settings as a means of patient involvement and self-management support

DEFF Research Database (Denmark)

Mejdahl, Caroline; Nielsen, Berit Kjærside; Hjøllund, Niels Henrik Ingvar

2016-01-01

Rationale, aims and objectives: Patient-reported outcomes (PROs) are being implemented in clinical practice across different healthcare settings with varying purposes. Involving patients in reporting outcomes may increase their attention to symptoms and thereby support their self-management. The ...... to strengthen patient involvement and securing benefit from PROs.......Rationale, aims and objectives: Patient-reported outcomes (PROs) are being implemented in clinical practice across different healthcare settings with varying purposes. Involving patients in reporting outcomes may increase their attention to symptoms and thereby support their self......-management. The aim of the present study was to describe patients’ experiences with a web-based PRO system where patients complete a PRO questionnaire at home or in the outpatient clinic prior to a consultation. Moreover, the study aimed to explore how PROs influenced the interaction between patients and clinicians...

Pay Now or Pay Later: An Economic Rationale for State-Funded Helping Services to Assist Women Leaving an Abusive Relationship.

Science.gov (United States)

DeRiviere, Linda

2015-01-01

There has been an increase in costing analysis of intimate partner violence in recent decades, including the monetary impact to government, society, and the individual. Using data collected in a Canadian longitudinal study, the empirical analysis in this article provides an economic rationale for mobilizing public resources that improve the well-being of women leaving an abusive relationship. I estimated six variants of a selection model and used a costing exercise to build an economic case for preventive and other helping services to support women over their healing journey. The removal of financial constraints suffered by abused women, in support of their training needs, as well as reduced barriers to preventive health care services, may potentially lead to fiscal resource savings in the long run.

Deconstructing the Brain Disconnection–Brain Death Analogy and Clarifying the Rationale for the Neurological Criterion of Death

Science.gov (United States)

Moschella, Melissa

2016-01-01

This article explains the problems with Alan Shewmon’s critique of brain death as a valid sign of human death, beginning with a critical examination of his analogy between brain death and severe spinal cord injury. The article then goes on to assess his broader argument against the necessity of the brain for adult human organismal integration, arguing that he fails to translate correctly from biological to metaphysical claims. Finally, on the basis of a deeper metaphysical analysis, I offer a revised rationale for the validity of the neurological criterion of human death. PMID:27095749

Is there a rationale for pulmonary rehabilitation following successful chemotherapy for tuberculosis?

Science.gov (United States)

Muñoz-Torrico, Marcela; Rendon, Adrian; Centis, Rosella; D'Ambrosio, Lia; Fuentes, Zhenia; Torres-Duque, Carlos; Mello, Fernanda; Dalcolmo, Margareth; Pérez-Padilla, Rogelio; Spanevello, Antonio; Migliori, Giovanni Battista

2016-01-01

ABSTRACT The role of tuberculosis as a public health care priority and the availability of diagnostic tools to evaluate functional status (spirometry, plethysmography, and DLCO determination), arterial blood gases, capacity to perform exercise, lesions (chest X-ray and CT), and quality of life justify the effort to consider what needs to be done when patients have completed their treatment. To our knowledge, no review has ever evaluated this topic in a comprehensive manner. Our objective was to review the available evidence on this topic and draw conclusions regarding the future role of the "post-tuberculosis treatment" phase, which will potentially affect several million cases every year. We carried out a non-systematic literature review based on a PubMed search using specific keywords (various combinations of the terms "tuberculosis", "rehabilitation", "multidrug-resistant tuberculosis", "pulmonary disease", "obstructive lung disease", and "lung volume measurements"). The reference lists of the most important studies were retrieved in order to improve the sensitivity of the search. Manuscripts written in English, Spanish, and Russian were selected. The main areas of interest were tuberculosis sequelae following tuberculosis diagnosis and treatment; "destroyed lung"; functional evaluation of sequelae; pulmonary rehabilitation interventions (physiotherapy, long-term oxygen therapy, and ventilation); and multidrug-resistant tuberculosis.The evidence found suggests that tuberculosis is definitively responsible for functional sequelae, primarily causing an obstructive pattern on spirometry (but also restrictive and mixed patterns), and that there is a rationale for pulmonary rehabilitation. We also provide a list of variables that should be discussed in future studies on pulmonary rehabilitation in patients with post-tuberculosis sequelae. PMID:27812638

Efficacy of Internet-Based Guided Treatment for Genito-Pelvic Pain/Penetration Disorder: Rationale, Treatment Protocol, and Design of a Randomized Controlled Trial.

Science.gov (United States)

Zarski, Anna-Carlotta; Berking, Matthias; Ebert, David Daniel

2017-01-01

Genito-pelvic pain/penetration disorder (GPPPD) not only adversely affects women's sexuality and sexual satisfaction but is also associated with a wide range of psychosocial consequences such as reduced quality of life and well-being, mental health comorbidities, and relationship distress. Evidence for effective treatment options is scarce. This article describes the rationale, treatment protocol, and study design for a randomized controlled trial examining the efficacy of an Internet-based guided intervention for GPPPD. Two hundred women who meet the criteria for GPPPD and have not been able to experience sexual intercourse for at least the last 6 months will be recruited and randomly assigned either to the intervention group (IG) or a 6-month waitlist control group. Assessments take place at baseline (T1), peritreatment after completion of Session 5 in IG (T2), after completion of Session 8 or 12 weeks after randomization (T3), and after 6 months (T4). Data will be analyzed on an intention-to-treat and a completer basis. The primary outcome will be sexual intercourse involving the insertion of the partner's penis at posttreatment. Secondary outcomes include, e.g., improved non-intercourse penetration, sexual functioning, dyadic stress coping, reduced fear of sexuality and negative penetration-related cognitions. Fear of sexuality, penetration-related cognitions, and exercise intensity will be assessed as mediators of intercourse in the IG. Sexual dysfunctions of partners will be measured at baseline (T1) and investigated as a potential moderator of the primary treatment outcome. Given the burden associated with GPPPD and the need for specialized treatment, there is a surprising lack of evidence-based treatment options. This study aims to assess whether Internet-based interventions could contribute to closing this treatment gap. German Register of Clinical Studies (DRKS): DRKS00010228.

Insights From Pre-Clinical and Clinical Studies on the Role of Innate Inflammation in Atherosclerosis Regression

Directory of Open Access Journals (Sweden)

Karishma Rahman

2018-05-01

Full Text Available Atherosclerosis, the underlying cause of coronary artery (CAD and other cardiovascular diseases, is initiated by macrophage-mediated immune responses to lipoprotein and cholesterol accumulation in artery walls, which result in the formation of plaques. Unlike at other sites of inflammation, the immune response becomes maladaptive and inflammation fails to resolve. The most common treatment for reducing the risk from atherosclerosis is low density lipoprotein cholesterol (LDL-C lowering. Studies have shown, however, that while significant lowering of LDL-C reduces the risk of heart attacks to some degree, there is still residual risk for the majority of the population. We and others have observed “residual inflammatory risk” of atherosclerosis after plasma cholesterol lowering in pre-clinical studies, and that this phenomenon is clinically relevant has been dramatically reinforced by the recent Canakinumab Anti-inflammatory Thrombosis Outcomes Study (CANTOS trial. This review will summarize the role of the innate immune system, specifically macrophages, in atherosclerosis progression and regression, as well as the pre-clinical and clinical models that have provided significant insights into molecular pathways involved in the resolution of plaque inflammation and plaque regression. Partnered with clinical studies that can be envisioned in the post-CANTOS period, including progress in developing targeted plaque therapies, we expect that pre-clinical studies advancing on the path summarized in this review, already revealing key mechanisms, will continue to be essential contributors to achieve the goals of dampening plaque inflammation and inducing its resolution in order to maximize the therapeutic benefits of conventional risk factor modifications, such as LDL-C lowering.

Nail disorders in children, a clinical study

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Ayşe Akbaş

2016-04-01

Full Text Available Introduction: Aims of the study to investigate the frequency and the nature ofnail disorders in children significant clinical data is available. Nail disorders although common in children in some parts of our country. This study was carried out to document the clinical and demographic pattern of nail disorders in a dermatology outpatient clinic of a pediatric hospital in Ankara, Turkey. Material and Methods: All consecutive patients a total of 3000 children from age 0-16 were admitted to dermatology outpatient clinic of Ankara Pediatric Hematology and Oncology Education and Research Hospital during January 2011 to December 2011 were studied and retrospectively evaluated for age, gender, drug use, diseases, systemic or genetic disorders and demographic features. Diagnostic evaluation results were noted and patients were categorized for demographic features and diagnosis. Results: These 133 patients (M: F 58:75, %44 vs 56, respectively were under 16 years of age and have 17 different dermatological disorders related with nail symptoms. Fifty three of (39,8% these patient were under 2 years of age, 31 (23.3% were between 3-5 years, 30 (22.5% were between 6-11 years old, 19 of 133 (14%, 2 were between 11-16 years of age. Through all of ages and independent of gender the most etiologies of nail disorders were, onychomadesis, paronychia, onycholysis, onychomycosis and systemic nail presentation of systemic dermatosis. Conclusion: Nail disorders are different in children than in adults. In our study, the first 5 years of age was found in 53% of nail disorders. Nail disorders are uncommon but may be seen as a part of a systemic disease and may be associated with cosmetic and psychologic problem.

Clinical and Statistical Study on Canine Impaction

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Adina-Simona Coșarcă

2013-08-01

Full Text Available Aim: The aim of this study was to perform a clinical and statistical research on permanent impacted canine patients among those with dental impaction referred to and treated at the Oral and Maxillo-Facial Surgery Clinic of Tîrgu Mureș, over a four years period (2009-2012. Materials and methods: The study included 858 patients having dental impaction, and upon clinical records, different parameters, like frequency, gender, age, quadrant involvement, patient residence, associated complications, referring specialist and type of treatment, related to canine impaction, were assessed. Results: The study revealed: about 10% frequency of canine impaction among dental impactions; more frequent in women, in the first quadrant (tooth 13; most cases diagnosed between the age of 10-19 years; patients under 20 were referred by an orthodontist, those over 20 by a dentist; surgical exposure was more often performed than odontectomy. Conclusions: Canine impaction is the second-most frequent dental impaction in dental arch after third molars; it occurs especially in women. Due to its important role, canine recovery within dental arch is a goal to be achieved, whenever possible. Therefore, diagnose and treatment of canine impaction requires an interdisciplinary approach (surgical and orthodontic

Performance Anxiety Disorder: Developing a Proposal for an Inventory, According to the Cognitive-Behavioural Therapy Rationale

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George Varvatsoulias

2017-10-01

Full Text Available This editorial aims at the presentation of a proposal regarding an inventory about performance anxiety disorder in a cognitive-behavioural therapy (CBT framework. It provides some initial understanding as to that condition and how CBT could assist in the consideration of it counter to social anxiety disorder. At first, there is an introduction to performance anxiety in line to social anxiety/phobia and some questionnaires that have been developed which include performance anxiety as an element of social anxiety/phobia. Then, I am presenting the proposal, both in view to the rationale for that and the construction of an inventory with items drawn from elements that performance anxiety is related with, such as uneasiness about worry, self-focus issues of perfectionism and internal/external shame ideas. The statements in the inventory refer to hypothetical examples in life so inventory to be easily responded to, when administered to participants. This proposal closes with the conclusion that the questionnaire will be pilot-studied in the future by the author so the feasibility of it and/or possible changes to be considered when empirically studied.

HANSENS DISEASE : STUDY OF CLINICAL, NEUROPATHOLOGICAL, NEUROPHYSIOLOGICAL PATTERN OF LEPROUS NEUROPATHY

OpenAIRE

Vijay Kumar; Ajay Kumar

2015-01-01

A need still exists to determine the clinical and neurophysiological characteristics of leprosy neuropathy at distinct times of the disease by different methods that measure the various nerve fiber functions. A prospective clinical study was performed 100 patients of clinically proven Hansen’s will take in study and given diagnosis is made by dermatologist and neurologist. For Study of Clinical, Neuropathological , Neurophysiological Pattern of leprous neuropathy and r...

Pathophysiology, prognostic significance and clinical utility of B-type natriuretic peptide in acute coronary syndromes.

Science.gov (United States)

Wiviott, Stephen D; de Lemos, James A; Morrow, David A

2004-08-16

The natriuretic hormones are a family of vasoactive peptides that can be measured circulating in the blood. Because they serve as markers of hemodynamic stress, the major focus of the use of natriuretic peptide levels [predominantly B-type natriuretic peptide (BNP) and N-terminal (NT)-pro-BNP] has been as an aid to the clinical diagnosis and management of congestive heart failure (CHF). Recently, however, the measurement of natriuretic peptides in the acute coronary syndromes (ACS) has been shown to provide information complementary to traditional biomarkers (of necrosis) such as cardiac troponins and creatine kinase (CK). Studies in several types of acute coronary syndromes [ST-segment elevation myocardial infarction (STEMI), non-ST elevation MI (NSTEMI) and unstable angina (UA)] have shown that elevated levels of natriuretic peptides are independently associated with adverse outcomes, particularly mortality. Additional information is obtained from the use natriuretic peptides in combination with other markers of risk including biomarkers of necrosis and inflammation. This review will summarize the scientific rationale and clinical evidence supporting measurement of natriuretic peptides for risk stratification in acute coronary syndromes. Future research is needed to identify therapies of particular benefit for patients with ACS and natriuretic peptide elevation.

Rationale and design of the screening of pulmonary hypertension in systemic lupus erythematosus (SOPHIE) study.

Science.gov (United States)

Huang, Duo; Cheng, Yang-Yang; Chan, Pak-Hei; Hai, Jojo; Yiu, Kai-Hang; Tse, Hung-Fat; Wong, Ka-Lam; Fan, Katherine; Li, Ying Wah; Ng, Woon-Leung; Yim, Cheuk-Wan; Wong, Cheuk-Hon John; Tam, Lai-Shan; Wong, Priscilla C H; Wong, Chi-Yuen; Ho, Chup-Hei; Leung, Alexander M H; Mok, Chi-Chiu; Lam, Ho; Lau, Chak-Sing; Cheung, Tommy; Ho, Carmen; Law, Sharon W Y; Chan, Esther W; Yin, Li-Xue; Yue, Wen-Sheng; Mok, Toi Meng; Evora, Mario Alberto; Siu, Chung-Wah

2018-01-01

Current guideline-recommended screening for pulmonary hypertension in patients with systemic sclerosis has not been evaluated in systemic lupus erythematosus (SLE), which is disproportionately prevalent in Asians. This multicentre, cross-sectional screening study aims to study the prevalence of pulmonary hypertension among SLE patients using these guidelines, and identify independent predictors and develop a prediction model for pulmonary hypertension in SLE patients. SLE patients from participating centres will undergo an echocardiography- and biomarker-based pulmonary hypertension screening procedure as in the DETECT study. Standard right heart catheterisation will be provided to patients with intermediate or high echocardiographic probability of pulmonary hypertension. Those with low echocardiographic probability will rescreen within 1 year. The primary measure will be the diagnosis and types of pulmonary hypertension and prevalence of pulmonary hypertension in SLE patients. The secondary measures will be the predictors and prediction models for pulmonary hypertension in SLE patients. The estimated sample size is approximately 895 participants. The results of the SOPHIE study will be an important contribution to the literature of SLE-related pulmonary hypertension and may be immediately translatable to real clinical practice. Ultimately, this study will provide the necessary evidence for establishing universal guidelines for screening of pulmonary hypertension in SLE patients.

West End Walkers 65+: A randomised controlled trial of a primary care-based walking intervention for older adults: Study rationale and design

Directory of Open Access Journals (Sweden)

Rowe David A

2011-02-01

Full Text Available Abstract Background In Scotland, older adults are a key target group for physical activity intervention due to the large proportion who are inactive. The health benefits of an active lifestyle are well established but more research is required on the most effective interventions to increase activity in older adults. The 'West End Walkers 65+' randomised controlled trial aims to examine the feasibility of delivering a pedometer-based walking intervention to adults aged ≥65 years through a primary care setting and to determine the efficacy of this pilot. The study rationale, protocol and recruitment process are discussed in this paper. Methods/Design The intervention consisted of a 12-week pedometer-based graduated walking programme and physical activity consultations. Participants were randomised into an immediate intervention group (immediate group or a 12-week waiting list control group (delayed group who then received the intervention. For the pilot element of this study, the primary outcome measure was pedometer step counts. Secondary outcome measures of sedentary time and physical activity (time spent lying/sitting, standing or walking; activPAL™ monitor, mood (Positive and Negative Affect Schedule, functional ability (Perceived Motor-Efficacy Scale for Older Adults, quality of life (Short-Form (36 Health Survey version 2 and loneliness (UCLA Loneliness Scale were assessed. Focus groups with participants and semi-structured interviews with the research team captured their experiences of the intervention. The feasibility component of this trial examined recruitment via primary care and retention of participants, appropriateness of the intervention for older adults and the delivery of the intervention by a practice nurse. Discussion West End Walkers 65+ will determine the feasibility and pilot the efficacy of delivering a pedometer-based walking intervention through primary care to Scottish adults aged ≥65 years. The study will also

A protocol for a randomized clinical trial of interactive video dance: potential for effects on cognitive function.

Science.gov (United States)

Jovancevic, Jelena; Rosano, Caterina; Perera, Subashan; Erickson, Kirk I; Studenski, Stephanie

2012-06-06

Physical exercise has the potential to affect cognitive function, but most evidence to date focuses on cognitive effects of fitness training. Cognitive exercise also may influence cognitive function, but many cognitive training paradigms have failed to provide carry-over to daily cognitive function. Video games provide a broader, more contextual approach to cognitive training that may induce cognitive gains and have carry over to daily function. Most video games do not involve physical exercise, but some novel forms of interactive video games combine physical activity and cognitive challenge. This paper describes a randomized clinical trial in 168 postmenopausal sedentary overweight women that compares an interactive video dance game with brisk walking and delayed entry controls. The primary endpoint is adherence to activity at six months. Additional endpoints include aspects of physical and mental health. We focus this report primarily on the rationale and plans for assessment of multiple cognitive functions. This randomized clinical trial may provide new information about the cognitive effects of interactive videodance. It is also the first trial to examine physical and cognitive effects in older women. Interactive video games may offer novel strategies to promote physical activity and health across the life span.The study is IRB approved and the number is: PRO08080012ClinicalTrials.gov Identifier: NCT01443455.

Rationale and design of the East-West late lumen loss study: Comparison of late lumen loss between Eastern and Western drug-eluting stent study cohorts.

Science.gov (United States)

Harrison, Robert W; Radhakrishnan, Vaishnavi; Lam, Peter S; Allocco, Dominic J; Brar, Sandeep; Fahy, Martin; Fisher, Rebecca; Ikeno, Fumiaki; Généreux, Philippe; Kimura, Takeshi; Liu, Minglei; Lye, Weng Kit; Mintz, Gary S; Nagai, Hirofumi; Suzuki, Yuka; White, Roseann; Allen, John C; Krucoff, Mitchell W

2016-12-01

The contemporary evaluation of novel drug-eluting stents (DES) includes mechanistic observations that characterize postdeployment stent behavior. Quantification of late lumen loss due to neointimal hyperplasia 8-13 months after stent implantation, via quantitative coronary angiography (QCA), constitutes such an observation and is required by most regulatory authorities. Late lumen loss, as determined by QCA, has been validated as a surrogate for clinical endpoints such as target vessel revascularization. The mechanistic response to DES has not been directly compared across predominantly Asian or Western populations, whereas understanding their comparability across geographic populations could enhance global DES evaluation. The East-West late lumen loss study is designed to demonstrate whether the residual differences in late lumen loss, as assessed by QCA, is different between Eastern and Western DES recipients from studies with protocol angiography at 8-13 months of follow-up. Data from independent core laboratories that have characterized angiographic late lumen loss in DES clinical trials with protocol follow-up angiography will be compiled and dichotomized into Eastern and Western populations. A prospectively developed propensity score model incorporating clinical and anatomic variables affecting late lumen loss will be used to adjust comparisons of QCA measurements. Documentation of whether there are clinically meaningful differences in mechanistic response to DES implantation across genetically unique geographies could facilitate both the quality and efficiency of global device evaluation requiring invasive follow-up for novel stent designs. Copyright © 2016 Elsevier Inc. All rights reserved.

A clinical study of geriatric dermatoses

OpenAIRE

Leena Raveendra

2014-01-01

Introduction: The geriatric population is composed of persons over 65 years of age and very few studies are available on the dermatologic diseases in this group. This study was done to study the spectrum of cutaneous manifestations and prevalence of physiological and pathological changes in the skin of elderly people. Material and Methods: Two hundred consecutive patients aged more than 65 years of age attending the outpatient clinic or admitted as inpatients in the Department of Dermato...

Upper limb robotics applied to neurorehabilitation: An overview of clinical practice.

Science.gov (United States)

Duret, Christophe; Mazzoleni, Stefano

2017-01-01

During the last two decades, extensive interaction between clinicians and engineers has led to the development of systems that stimulate neural plasticity to optimize motor recovery after neurological lesions. This has resulted in the expansion of the field of robotics for rehabilitation. Studies in patients with stroke-related upper-limb paresis have shown that robotic rehabilitation can improve motor capacity. However, few other applications have been evaluated (e.g. tremor, peripheral nerve injuries or other neurological diseases). This paper presents an overview of the current use of upper limb robotic systems for neurorehabilitation, and highlights the rationale behind their use for the assessment and treatment of common neurological disorders. Rehabilitation robots are little integrated in clinical practice, except after stroke. Although few studies have been carried out to evaluate their effectiveness, evidence from the neurosciences and indications from pilot studies suggests that upper limb robotic rehabilitation can be applied safely in various other neurological conditions. Rehabilitation robots provide an intensity, quality and dose of treatment that exceeds therapist-mediated rehabilitation. Moreover, the use of force fields, multi-sensory environments, feedback etc. renders such rehabilitation engaging and motivating. Future studies should evaluate the effectiveness of rehabilitation robots in neurological pathologies other than stroke.

A randomized clinical trial of how to best position retropubic slings for stress urinary incontinence: Development of a study protocol for the mid-urethral sling tensioning (MUST) trial.

Science.gov (United States)

Brennand, Erin A; Kim-Fine, Shunaha

2016-08-15

The goal of this trial is to compare two techniques for tensioning retropubic midurethral slings: a Mayo scissor between the tape and urethra vs. a Babcock clamp creating a measured loop underneath the urethra. The primary outcome is a composite of abnormal bladder function at 12 months post surgery. Abnormal bladder function is defined as bothersome stress incontinence or worsening over active bladder symptoms, a positive cough stress test, re-treatment of stress urinary incontinence, post-operative urinary retention requiring either catheterization beyond 6 weeks or surgical intervention. Secondary outcomes include the duration of post operative urinary retention, quality of life scores, and physical examination. This article describes the rationale and design of this clinical trial, which will be of interest to those who care for patient with pelvic floor disorders such as stress urinary incontinence.

[A clinical study of endodontic flare-ups].

Science.gov (United States)

Yeh, S J; Lin, Y T; Lu, S Y

1994-06-01

The purpose of this study was to investigate the clinical variables influencing endodontic flare-ups. Three hundred and thirteen teeth receiving endodontic treatment at the Endodontic Department, Chang Gung Memorial Hospital were studied from December 1992 to February 1993. Among them, 21 teeth with significant pain and 9 with apical swelling were noted after the first appointment of treatment. Three teeth with persistent pain and one with apical swelling were also found one week after completion of endodontic therapy. The results showed significant improvement of clinical symptoms and signs one week after completion of endodontic treatment in comparison with pretreatment and after the first appointment (p endodontic flare-ups after the first appointment of treatment (P endodontic flare-ups.

Instantaneous Wave-Free Ratio versus Fractional Flow Reserve guided intervention (iFR-SWEDEHEART): Rationale and design of a multicenter, prospective, registry-based randomized clinical trial.

Science.gov (United States)

Götberg, Matthias; Christiansen, Evald H; Gudmundsdottir, Ingibjörg; Sandhall, Lennart; Omerovic, Elmir; James, Stefan K; Erlinge, David; Fröbert, Ole

2015-11-01

Instantaneous wave-free ratio (iFR) is a new hemodynamic resting index for assessment of coronary artery stenosis severity. iFR uses high frequency sampling to calculate a gradient across a coronary lesion during a period of diastole. The index has been tested against fractional flow reserve (FFR) and found to have an overall classification agreement of 80% to 85%. Whether the level of disagreement is clinically relevant is unknown. Clinical outcome data on iFR are scarce. This study is a registry-based randomized clinical trial, which is a novel strategy using health quality registries as on-line platforms for randomization, case record forms, and follow-up. iFR-SWEDEHEART is a multicenter, prospective, randomized, controlled, clinical open-label clinical trial. Two thousand patients with stable angina or acute coronary syndrome and an indication for physiology-guided assessment of one or more coronary stenoses will be randomized 1:1 to either iFR- or FFR-guided intervention. The randomization will be conducted online in the Swedish web-based system for enhancement and development of evidence-based care in heart disease evaluated according to recommended therapies (SWEDEHEART) registry. The trial has a non-inferiority design, with a primary combined end point of all-cause death, non-fatal myocardial infarction, and unplanned revascularization at 12 months. End points will be identified through national registries and undergo central blind adjudication to ensure data quality. The iFR-SWEDEHEART trial is an registry-based randomized clinical trial evaluating the safety and efficacy of the diagnostic method iFR compared to FFR. Copyright © 2015 Elsevier Inc. All rights reserved.

A multicenter study: how do medical students perceive clinical learning climate?

Science.gov (United States)

Yilmaz, Nilufer Demiral; Velipasaoglu, Serpil; Ozan, Sema; Basusta, Bilge Uzun; Midik, Ozlem; Mamakli, Sumer; Karaoglu, Nazan; Tengiz, Funda; Durak, Halil İbrahim; Sahin, Hatice

2016-01-01

The relationship between students and instructors is of crucial importance for the development of a positive learning climate. Learning climate is a multifaceted concept, and its measurement is a complicated process. The aim of this cross-sectional study was to determine medical students' perceptions about the clinical learning climate and to investigate differences in their perceptions in terms of various variables. Medical students studying at six medical schools in Turkey were recruited for the study. All students who completed clinical rotations, which lasted for 3 or more weeks, were included in the study (n=3,097). Data were collected using the Clinical Learning Climate Scale (CLCS). The CLCS (36 items) includes three subscales: clinical environment, emotion, and motivation. Each item is scored using a 5-point Likert scale (1: strongly disagree to 5: strongly agree). The response rate for the trainees was 69.67% (n=1,519), and for the interns it was 51.47% (n=917). The mean total CLCS score was 117.20±17.19. The rotation during which the clinical learning climate was perceived most favorably was the Physical Therapy and Rehabilitation rotation (mean score: 137.77). The most negatively perceived rotation was the General Internal Medicine rotation (mean score: 104.31). There were significant differences between mean total scores in terms of trainee/intern characteristics, internal medicine/surgical medicine rotations, and perception of success. The results of this study drew attention to certain aspects of the clinical learning climate in medical schools. Clinical teacher/instructor/supervisor, clinical training programs, students' interactions in clinical settings, self-realization, mood, students' intrinsic motivation, and institutional commitment are important components of the clinical learning climate. For this reason, the aforementioned components should be taken into consideration in studies aiming to improve clinical learning climate.

A multicenter study: how do medical students perceive clinical learning climate?

Directory of Open Access Journals (Sweden)

Nilufer Demiral Yilmaz

2016-09-01

Full Text Available Background: The relationship between students and instructors is of crucial importance for the development of a positive learning climate. Learning climate is a multifaceted concept, and its measurement is a complicated process. The aim of this cross-sectional study was to determine medical students’ perceptions about the clinical learning climate and to investigate differences in their perceptions in terms of various variables. Methods: Medical students studying at six medical schools in Turkey were recruited for the study. All students who completed clinical rotations, which lasted for 3 or more weeks, were included in the study (n=3,097. Data were collected using the Clinical Learning Climate Scale (CLCS. The CLCS (36 items includes three subscales: clinical environment, emotion, and motivation. Each item is scored using a 5-point Likert scale (1: strongly disagree to 5: strongly agree. Results: The response rate for the trainees was 69.67% (n=1,519, and for the interns it was 51.47% (n=917. The mean total CLCS score was 117.20±17.19. The rotation during which the clinical learning climate was perceived most favorably was the Physical Therapy and Rehabilitation rotation (mean score: 137.77. The most negatively perceived rotation was the General Internal Medicine rotation (mean score: 104.31. There were significant differences between mean total scores in terms of trainee/intern characteristics, internal medicine/surgical medicine rotations, and perception of success. Conclusion: The results of this study drew attention to certain aspects of the clinical learning climate in medical schools. Clinical teacher/instructor/supervisor, clinical training programs, students’ interactions in clinical settings, self-realization, mood, students’ intrinsic motivation, and institutional commitment are important components of the clinical learning climate. For this reason, the aforementioned components should be taken into consideration in studies

Summary reports for key Hoodia clinical studies

CSIR Research Space (South Africa)