WorldWideScience

Sample records for study protocol submissions

  1. Study protocol

    DEFF Research Database (Denmark)

    Madsen, Helle Østergaard; Dam, Ole Henrik; Hageman, Ida

    2012-01-01

    yields a Global Seasonal Score and a prevalence of SAD. Outcomes from the two groups will be compared. Moreover, outcomes from subgroups of the visually impaired population will be compared. ETHICS AND DISSEMINATION: The study is approved by the Danish Data Protection Agency. Results will be published...

  2. Study protocol

    DEFF Research Database (Denmark)

    Thorsteinsson, Troels; Helms, Anne Sofie; Adamsen, Lis

    2013-01-01

    . Secondary endpoints are quality of life measured by validated questionnaires and interviews, and physical performance. RESPECT includes a multimodal intervention program, including ambassador-facilitated educational, physical, and social interventions. The educational intervention includes an educational...... to interaction with peers.Methods/design: The RESPECT study is a nationwide population-based prospective, controlled, mixed-methods intervention study looking at children aged 6-18 years newly diagnosed with cancer in eastern Denmark (n = 120) and a matched control group in western Denmark (n = 120). RESPECT...... program aimed at the child with cancer, the child's schoolteachers and classmates, and the child's parents. Children with cancer will each have two ambassadors assigned from their class. The ambassadors visit the child with cancer at the hospital at alternating 2-week intervals and participate...

  3. Journal of Cultural Studies: Submissions

    African Journals Online (AJOL)

    Bibliographic referencing within and at the end of each paper should follow the MLA style. An abstract of between 150 and 200 words, and a cover page, which indicates the full name and brief bio-data of the author, should accompany each submission. The cover page should be typed separately from the manuscript, which ...

  4. An updated protocol to detect invalid entries in an online survey of men who have sex with men (MSM): how do valid and invalid submissions compare?

    Science.gov (United States)

    Grey, Jeremy A; Konstan, Joseph; Iantaffi, Alex; Wilkerson, J Michael; Galos, Dylan; Rosser, B R Simon

    2015-10-01

    Researchers use protocols to screen for suspicious survey submissions in online studies. We evaluated how well a de-duplication and cross-validation process detected invalid entries. Data were from the Sexually Explicit Media Study, an Internet-based HIV prevention survey of men who have sex with men. Using our protocol, 146 (11.6 %) of 1254 entries were identified as invalid. Most indicated changes to the screening questionnaire to gain entry (n = 109, 74.7 %), matched other submissions' payment profiles (n = 56, 41.8 %), or featured an IP address that was recorded previously (n = 43, 29.5 %). We found few demographic or behavioral differences between valid and invalid samples, however. Invalid submissions had lower odds of reporting HIV testing in the past year (OR 0.63), and higher odds of requesting no payment compared to check payments (OR 2.75). Thus, rates of HIV testing would have been underestimated if invalid submissions had not been removed, and payment may not be the only incentive for invalid participation.

  5. 'Submission'

    DEFF Research Database (Denmark)

    Berg-Sørensen, Anders

    2017-01-01

    On 7 January 2015, the day of the deadly attack on Charlie Hebdo, the Parisian satirical magazine, French author Michel Houellebecq published Soumission (Submission), his already contested novel. Charlie Hebdo had a satirical feature on the cover that day ridiculing Houellebecq’s novel, which...

  6. Critical Studies in Teaching and Learning: Submissions

    African Journals Online (AJOL)

    Submissions must be original research, and must be between 5000 and 8000 words excluding references and endnotes. STYLE GUIDE ... The journal uses U.K. punctuation and spelling, following The Oxford English Dictionary (OED). Foreign words .... In Jones, C., Turner, J. & Street, B.V. Students Writing in the University.

  7. International Journal of Humanistic Studies: Submissions

    African Journals Online (AJOL)

    Manuscripts are refereed anonymously; therefore, the author's name, e-mail address, and brief contributor information (not exceeding fifty words) should appear on the title page only. All pages must be numbered. The Journal prefers submissions sent as an e-mail attachment editoruniswaijhs@yahoo.com in Microsoft Word.

  8. NEURAPRO-E study protocol

    DEFF Research Database (Denmark)

    Markulev, Connie; McGorry, Patrick D; Nelson, Barnaby

    2017-01-01

    polyunsaturated fatty acids (PUFAs), coupled with the falling transition rate in ultra high-risk (UHR) samples, mean that further study of such benign, potentially neuroprotective interventions is clinically and ethically required. Employing a multicentre approach, enabling a large sample size, this study...... response to omega-3 PUFA treatment in the UHR group. CONCLUSION: This is the protocol of the NeuraproE study. Utilizing a large sample, results from this study will be important in informing indicated prevention strategies for schizophrenia and other psychotic disorders, which may be the strongest avenue...

  9. 78 FR 70954 - Transport Format for the Submission of Regulatory Study Data; Notice of Pilot Project

    Science.gov (United States)

    2013-11-27

    ... HUMAN SERVICES Food and Drug Administration Transport Format for the Submission of Regulatory Study Data...) transport format for the submission of regulatory study data. The current study data transport format supported by FDA is the SAS Transport (XPORT) version 5 file format. Although XPORT has been a reliable...

  10. The transmission protocols of gender as female submission device to marital violence

    Directory of Open Access Journals (Sweden)

    Maria Fátima Scaffo

    2011-12-01

    Full Text Available This article examines the way in which women historically respond , in the familiar scenario, to marital violence. In principle, the snip, adopted as an object of study and analysis, consists of a typical mode of violence to the woman filed in the context of the cogs which  configure  the encounter between men and women. It points out the factors enhanced in this  meeting  which produce violence, exploring the  the possibility to reflect on aspects of the masculine condition or in ghosts   of the feminine universe. Considering the gender issue,    the following question is raised: Is the position of women  constructed based on educational principles  which determine  a particular type of role to  them or are there  other determinants? The analysis and discussion of this theme will be carried out considering the generational transmission of norms of gender-protocols from mother to daughter as well as  the constant reissue, in an unreflective manner, , that has been constituted as formative  roots of the   women’s behavior and which are part of the dynamics of the feminine in gender relations, in which the woman occupies a historically subordinate plan. Probably the condition of inferiority reflects  the transmission, from mother to daughter, of stereotyped patterns culturally assigned to women and that are accepted and replicated, almost automatically, in the scenario of marital relations.

  11. Journal of Development and Communication Studies: Submissions

    African Journals Online (AJOL)

    Author Guidelines. The Journal of Development & Communication Studies is a quarterly journal that accepts academic research articles, talks, essays, conference papers, brief case studies, and book reviews that conform to the following specifications: 1) Full length academic research articles: Maximum 30 pages including ...

  12. Statistical principles for prospective study protocols:

    DEFF Research Database (Denmark)

    Christensen, Robin; Langberg, Henning

    2012-01-01

    In the design of scientific studies it is essential to decide on which scientific questions one aims to answer, just as it is important to decide on the correct statistical methods to use to answer these questions. The correct use of statistical methods is crucial in all aspects of research...... (rigorous) protocol writing too troublesome, will realize that they have already written the first half of the final paper if they follow these recommendations; authors simply need to change the protocols future tense into past tense. Thus, the aim of this clinical commentary is to describe and explain...

  13. E-submission chronic toxicology study supplemental files

    Science.gov (United States)

    The formats and instructions in these documents are designed to be used as an example or guide for registrants to format electronic files for submission of animal toxicology data to OPP for review in support of registration and reevaluation of pesticides.

  14. 76 FR 64368 - Notice of Submission of Proposed Information Collection to OMB Homelessness Prevention Study

    Science.gov (United States)

    2011-10-18

    ... URBAN DEVELOPMENT Notice of Submission of Proposed Information Collection to OMB Homelessness Prevention... site visits that are part of HUD's Homelessness Prevention Study. The proposed information collection... collection for the Homelessness Prevention study that was already approved under emergency review (OMB...

  15. 75 FR 54886 - Submission for OMB Review; Comment Request; the Framingham Heart Study (FHS)

    Science.gov (United States)

    2010-09-09

    ... HUMAN SERVICES National Institutes of Health Submission for OMB Review; Comment Request; the Framingham... studying the determinants of cardiovascular disease. Examinations will be conducted on the original...; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize...

  16. 78 FR 42084 - Electronic Study Data Submission; Data Standard Support; Availability of the Center for Drug...

    Science.gov (United States)

    2013-07-15

    ... HUMAN SERVICES Food and Drug Administration Electronic Study Data Submission; Data Standard Support... Drug Administration, HHS. ACTION: Notice. SUMMARY: The Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration (FDA) is announcing the availability of the CDER Data Standards...

  17. 78 FR 5816 - Electronic Study Data Submission; Data Standard Support End Date

    Science.gov (United States)

    2013-01-28

    ... HUMAN SERVICES Food and Drug Administration Electronic Study Data Submission; Data Standard Support End Date AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Center for Biologics... CONTACT: Virginia Hussong, Center for Drug Evaluation and Research, Food and Drug Administration, 10903...

  18. Quantitative methods for studying design protocols

    CERN Document Server

    Kan, Jeff WT

    2017-01-01

    This book is aimed at researchers and students who would like to engage in and deepen their understanding of design cognition research. The book presents new approaches for analyzing design thinking and proposes methods of measuring design processes. These methods seek to quantify design issues and design processes that are defined based on notions from the Function-Behavior-Structure (FBS) design ontology and from linkography. A linkograph is a network of linked design moves or segments. FBS ontology concepts have been used in both design theory and design thinking research and have yielded numerous results. Linkography is one of the most influential and elegant design cognition research methods. In this book Kan and Gero provide novel and state-of-the-art methods of analyzing design protocols that offer insights into design cognition by integrating segmentation with linkography by assigning FBS-based codes to design moves or segments and treating links as FBS transformation processes. They propose and test ...

  19. 77 FR 9945 - Draft Guidance for Industry on Providing Submissions in Electronic Format-Standardized Study Data...

    Science.gov (United States)

    2012-02-21

    ... current thinking on the submission of study data in a standard electronic format. The draft guidance... current thinking on submitting standardized study data in electronic format. It does not create or confer... Electronic Format--Standardized Study Data; Availability AGENCY: Food and Drug Administration, HHS. ACTION...

  20. 77 FR 19267 - Notice of Submission for OMB Review; Institute of Education Sciences; Study of Promising Features...

    Science.gov (United States)

    2012-03-30

    ... pair of teachers in the same school and grade level, one of whom will have experienced the type of... states for the study, selecting the specific features related to clinical practice (i.e., the ``program... Notice of Submission for OMB Review; Institute of Education Sciences; Study of Promising Features of...

  1. Japan Unified Protocol Clinical Trial for Depressive and Anxiety Disorders (JUNP study): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Ito, Masaya; Okumura, Yasuyuki; Horikoshi, Masaru; Kato, Noriko; Oe, Yuki; Miyamae, Mitsuhiro; Hirabayashi, Naotsugu; Kanie, Ayako; Nakagawa, Atsuo; Ono, Yutaka

    2016-03-18

    The unified protocol for the transdiagnostic treatment of emotional disorders is a promising treatment approach that could be applicable to a broad range of mental disorders, including depressive, anxiety, trauma-related, and obsessive-compulsive disorders. However, no randomized controlled trial has been conducted to verify the efficacy of the unified protocol on the heterogeneous clinical population with depressive and anxiety disorders. The trial was designed as a single-center, assessor-blinded, randomized, 20-week, parallel-group superiority study in order to compare the efficacy of the combination of unified protocol and treatment-as-usual versus waiting-list with treatment-as-usual for patients with depressive and/or anxiety disorders. The primary outcome was depression at 21 weeks, assessed by the 17-item version of the GRID-Hamilton Rating Scale for Depression. Estimated minimum sample size was 27 participants in each group. We will also examine the treatment mechanisms, treatment processes, and neuropsychological correlates. The results of this study will clarify the efficacy of the unified protocol for depressive and anxiety disorders, and the treatment mechanism, process, and neurological correlates for the effectiveness of the unified protocol. If its efficacy can be confirmed, the unified protocol may be of high clinical value for Japan, a country in which cognitive behavioral treatment has not yet been widely adopted. ClinicalTrials.gov NCT02003261 (registered on December 2, 2013).

  2. 75 FR 76706 - Acceptance of Public Submissions on a Study Mandated by the Dodd-Frank Wall Street Reform and...

    Science.gov (United States)

    2010-12-09

    ..., Division of Risk, Strategy, and Financial Innovation, Securities and Exchange Commission, 100 F Street, NE... to capture one set of information versus another? 40. Would there be a benefit to making the computer... COMMISSION SECURITIES AND EXCHANGE COMMISSION Acceptance of Public Submissions on a Study Mandated by the...

  3. 76 FR 44508 - Acceptance of Public Submissions for a Study on International Swap Regulation Mandated by Section...

    Science.gov (United States)

    2011-07-26

    ..., currency swaps, interest rate swaps (IRS),\\22\\ and commodity swaps; \\21\\ For CDS, include: corporate single... contracts, such as CDS, equity swaps, currency swaps, IRS, and commodity swaps; b. For classes and... Submissions for a Study on International Swap Regulation Mandated by Section 719(c) of the Dodd-Frank Wall...

  4. The Ischemic Stroke Genetics Study (ISGS Protocol

    Directory of Open Access Journals (Sweden)

    Rich Stephen S

    2003-07-01

    Full Text Available Abstract Background The molecular basis for the genetic risk of ischemic stroke is likely to be multigenic and influenced by environmental factors. Several small case-control studies have suggested associations between ischemic stroke and polymorphisms of genes that code for coagulation cascade proteins and platelet receptors. Our aim is to investigate potential associations between hemostatic gene polymorphisms and ischemic stroke, with particular emphasis on detailed characterization of the phenotype. Methods/Design The Ischemic Stroke Genetic Study is a prospective, multicenter genetic association study in adults with recent first-ever ischemic stroke confirmed with computed tomography or magnetic resonance imaging. Patients are evaluated at academic medical centers in the United States and compared with sex- and age-matched controls. Stroke subtypes are determined by central blinded adjudication using standardized, validated mechanistic and syndromic classification systems. The panel of genes to be tested for polymorphisms includes β-fibrinogen and platelet glycoprotein Ia, Iba, and IIb/IIIa. Immortalized cell lines are created to allow for time- and cost-efficient testing of additional candidate genes in the future. Discussion The study is designed to minimize survival bias and to allow for exploring associations between specific polymorphisms and individual subtypes of ischemic stroke. The data set will also permit the study of genetic determinants of stroke outcome. Having cell lines will permit testing of future candidate risk factor genes.

  5. Statistical principles for prospective study protocols:

    DEFF Research Database (Denmark)

    Christensen, Robin; Langberg, Henning

    2012-01-01

    In the design of scientific studies it is essential to decide on which scientific questions one aims to answer, just as it is important to decide on the correct statistical methods to use to answer these questions. The correct use of statistical methods is crucial in all aspects of research to qu...

  6. Continuous sawmill studies: protocols, practices, and profits

    Science.gov (United States)

    Robert Mayer; Jan Wiedenbeck

    2005-01-01

    In today's global economy, the "opportunity cost" associated with suboptimal utilization of raw material and mill resources is significant. As a result, understanding the profit potential associated with different types of logs is critically important for sawmill survival. The conventional sawmill study typically has been conducted on a substantially...

  7. Protocols to Study Aging in Drosophila.

    Science.gov (United States)

    Piper, Matthew D W; Partridge, Linda

    2016-01-01

    The fruit fly Drosophila melanogaster offers a host of advantages for studying the biology of aging: a well-understood biology, a wide range of genetic reagents, well-defined dietary requirements, and a relatively short life span, with a median of ~80 days and maximum ~100 days. Several phenotypes can be used to assess the aging process, but the simplest and most widely used metric is length of life. Here we describe a standard life span assay for Drosophila housed on a simple sugar/yeast diet.

  8. COASTAL STUDY Submission for Lafourche Parish, LA, USA

    Data.gov (United States)

    Federal Emergency Management Agency, Department of Homeland Security — Coastal study data as defined in FEMA Guidelines and Specifications, Appendix D: Guidance for Coastal Flooding Analyses and Mapping, submitted as a result of a...

  9. From Postpartum Haemorrhage Guideline to Local Protocol: A Study of Protocol Quality

    NARCIS (Netherlands)

    Woiski, Mallory D.; van Vugt, Helena C.; Dijkman, Anneke; Grol, Richard P.; Marcus, Abraham; Middeldorp, Johanna M.; Mol, Ben W.; Mols, Femke; Oudijk, Martijn A.; Porath, Martina; Scheepers, Hubertina J.; Hermens, Rosella P.

    2016-01-01

    Objective Postpartum hemorrhage (PPH) has a continuously rising incidence worldwide, suggesting suboptimal care. An important step in optimizing care is the translation of evidence-based guidelines into comprehensive hospital protocols. However, knowledge about the quality of these protocols is

  10. Investigation of self-compassion, self-confidence and submissive behaviors of nursing students studying in different curriculums.

    Science.gov (United States)

    Eraydın, Şahizer; Karagözoğlu, Şerife

    2017-07-01

    Today, nursing education which educates the future members of the nursing profession aims to gain them high self-esteem, selfconfidence and self-compassion, independence, assertiveness and ability to establish good human relations. This aim can only be achieved through a contemporary curriculum supporting students in the educational process and enabling those in charge to make arrangements by taking the characters and needs of each individual into account. The study aims to investigate self-compassion, self-confidence and submissive behaviours of undergraduate nursing students studying in different curriculums. This descriptive, cross-sectional, comparative study was carried out with the 1st- and 4th-year students of the three schools, each of which has a different curriculum: conventional, integrated and Problem Based Learning (PBL). The study data were collected with the Self-Compassion Scale (SCS), Self-Confidence Scale (CS) and Submissive Acts Scale (SAS): The data were analyzed through frequency distribution, means, analysis of variance and the significance test for the difference between the two means. The mean scores the participating students obtained from the Self-Compassion, Self-confidence and Submissive Acts Scales were 3.31±0.56, 131.98±20.85 and 36.48±11.43 respectively. The integrated program students' mean self-compassion and self-confidence scores were statistically significantly higher and their mean submissive behaviour scores were lower than were those of the students studying in the other two programs (pnursing students tended to display moderate levels of selfcompassion, self-confidence and submissive behaviours, and that the selfcompassion and self-confidence scores of the 4th-year students in the integrated program were higher than were those of the students in the other two programs. Copyright © 2017 Elsevier Ltd. All rights reserved.

  11. Epidemiological characterization of oral cancer. Study Protocol.

    Directory of Open Access Journals (Sweden)

    Alejandra Fernández

    2015-04-01

    Full Text Available Oral cancer is a disease of high impact globally. It ranks as the sixth more frequent one among all types of cancer. In spite of being a widely known pathology and easy access to the diagnosis, the lack of epidemiological data reported in the last 10 years in Chile called attention to. At the global level, the World Health Organization (WHO has developed a project called “GLOBOCAN” in order to collect epidemiological data of the global cancer, between its data, highlights the high incidence and high rate of mortality in the male sex, parameter that shows tendency to replicate in both America and Chile. In consequence to these data, a narrative review of the literature concerning the epidemiological profile of the different forms of oral cancer in the past 15 years was done. The diagnosis of oral cancer crosses transversely the Dental Science, forcing us to establish triads of work between oral and maxillofacial surgeons, pathologists and dentists of the various specialties, so as to allow a timely research, appropriate biopsies and histopathological studies finishes with the purpose of, on the one hand, obtain timely and accurate diagnostics, in addition, maintaining the epidemiological indicators.

  12. Publishing protocols for partnered research.

    Science.gov (United States)

    Hysong, Sylvia J; Woodard, LeChauncy; Garvin, Jennifer H; Murawsky, Jeffrey; Petersen, Laura A

    2014-12-01

    Published scientific protocols are advocated as a means of controlling bias in research reporting. Indeed, many journals require a study protocol with manuscript submission. However, publishing protocols of partnered research (PPR) can be challenging in light of the research model's dynamic nature, especially as no current reporting standards exist. Nevertheless, as these protocols become more prevalent, a priori documentation of methods in partnered research studies becomes increasingly important. Using as illustration a suite of studies aimed at improving coordination and communication in the primary care setting, we sought to identify challenges in publishing PPR relative to traditional designs, present alternative solutions to PPR publication, and propose an initial checklist of content to be included in protocols of partnered research. Challenges to publishing PPR include reporting details of research components intended to be co-created with operational partners, changes to sampling and entry strategy, and alignment of scientific and operational goals. Proposed solutions include emulating reporting standards of qualitative research, participatory action research, and adaptive trial designs, as well as embracing technological tools that facilitate publishing adaptive protocols, with version histories that are able to be updated as major protocol changes occur. Finally, we present a proposed checklist of reporting elements for partnered research protocols.

  13. Study protocol for the Cities Changing Diabetes programme

    DEFF Research Database (Denmark)

    Napier, A David; Nolan, John J; Bagger, Malene

    2017-01-01

    . The majority of people with diabetes have type 2 diabetes, a subset linked to overweight and obesity, decreased physical activity and unhealthy diets. Diabetes has significant consequences for those living with the condition as well as their families, relationships and wider society. Although care...... the Cities Changing Diabetes (CCD) partnership programme. METHODS AND ANALYSIS: A global study protocol is implemented in eight collaborating CCD partner cities. In each city, academic institutions, municipal representatives and local stakeholders collaborate to set research priorities and plan...... implementation of findings. Local academic teams execute the study following the global study protocol presented here. A quantitative Rule of Halves analysis obtains measures of the magnitude of the diabetes burden, the diagnosis rates in each city and the outcomes of care. A qualitative Diabetes Vulnerability...

  14. Study on the Personal Submission of Agricultural Product Samples for Quality and Safety Inspection

    OpenAIRE

    ZHAO, Dan; WANG, Yan; ZHANG, Yongzhi; CUI, Yehan; LIU, Pengcheng; ZHOU, Yunlong; LI, Yueru

    2015-01-01

    This paper carries out a questionnaire survey on 30 quality inspection institutions at the level of the Ministry of Agriculture, and based on systematic analysis, analyzes the causes of difficulties in personal submission of samples for inspection from six aspects in order to meet the real needs of personal submission of agricultural product samples for inspection under the new situation. In accordance with the actual situation of China's current regulatory system and quality control system, ...

  15. A proposal for an Italian minimum data set assessment protocol for robot-assisted rehabilitation: a Delphi study.

    Science.gov (United States)

    Franceschini, M; Colombo, R; Posteraro, F; Sale, P

    2015-12-01

    At present there is no agreement on a common evaluation protocol to assess improvement in stroke patients after robotic therapy. The aim of this study was to identify a Minimum Data Set Assessment Protocol, using an agreement-based survey. A Delphi survey. This study was conceived by the Italian Robotic Neurorehabilitation Research Group (IRNRG), an Italian group involved in the clinical application of robot-assisted rehabilitation devices Stroke subjects. A 3-round Delphi survey was carried out through the electronic submission of questionnaires to a panel of experts identified in fourteen rehabilitation centers. For each generated item, experts were asked to rate questions on a 5 point Likert Scale. After the 1st round the questionnaire was filled out by 43 (84.3%) out of 51 experts invited to participate in the study. In the 2nd and 3rd rounds we explored the specific evaluation tools for each of the ICF domains identified in the 1st round. The experts identified the following assessment tools for the upper limb: the Ashworth Scale, the Fugl-Meyer assessment scale, the Frenchay Arm Test, the Medical Research Council scale, the Motricity Index, Frenchay Activities Index and Modified Barthel Index; and for the lower limb: the Ashworth Scale, the Motricity Index, the 10 meter walking Test, the 6 minutes walking Test, the Functional Ambulatory Classification, the Timed Up and Go Test, the Walking Handicap Scale, the Borg Rating of Perceived Exertion, the Heart Rate, the Medical Research Council Scale, the Tinetti Balance Scale and the Modified Barthel Index. The Delphi survey presented in this study allows the identification of a shared assessment protocol to be applied in clinical practice and research for the evaluation of the real improvement related to robot-assisted rehabilitation of the upper and lower limb in patients after stroke. Clinicians and researchers could use the results of this study to obtain a common language in robotic rehabilitation assessments.

  16. Zimbabwe Science News: Submissions

    African Journals Online (AJOL)

    Submission Preparation Checklist. As part of the submission process, authors are required to check off their submission's compliance with all of the following items, and submissions may be returned to authors that do not adhere to these guidelines. The submission has not been previously published, nor is it before another ...

  17. Multi-centre, multi-database studies with common protocols

    DEFF Research Database (Denmark)

    Klungel, Olaf H.; Kurz, Xavier; de Groot, Mark C.H.

    2016-01-01

    to study a broad range of methodological issues. Common protocols and data analytical specifications were jointly developed and independently and blindly executed in different databases in Europe with replications in the same and different databases. Results: The association between antibiotics and acute...... was observed depending on design, exposure and outcome definitions, but none of the differences were statistically significant. The association between anti-epileptics and suicidality was inconsistent across the UK CPRD, Danish National registries and the French PGRx system. Calcium channel blockers were...

  18. An improved pyrite pretreatment protocol for kinetic and isotopic studies

    Science.gov (United States)

    Mirzoyan, Natella; Kamyshny, Alexey; Halevy, Itay

    2014-05-01

    An improved pyrite pretreatment protocol for kinetic and isotopic studies Natella Mirzoyan1, Alexey Kamyshny Jr.2, Itay Halevy1 1Earth and Planetary Sciences, Weizmann Institute of Science, Rehovot 76100, Israel 2Geological and Environmental Sciences, Ben-Gurion University of the Negev, Beer Sheva 84105, Israel Pyrite is one of the most abundant and widespread of the sulfide minerals with a central role in biogeochemical cycles of iron and sulfur. Due to its diverse roles in the natural and anthropogenic sulfur cycle, pyrite has been extensively studied in various experimental investigations of the kinetics of its dissolution and oxidation, the isotopic fractionations associated with these reactions, and the microbiological processes involved. Pretreatment of pyrite for removal of oxidation impurities to prevent experimental artifacts and inaccuracies is often practiced. While numerous pyrite-cleaning methods have been used in experiments, a common pyrite pretreatment method, often used to investigate pyrite chemistry by the isotopic fractionations associated with it, includes several rinses by HCl, acetone and deionized water. Elemental sulfur (S0) is a common product of incomplete pyrite oxidation. Removal of S0 is desirable to avoid experimental biases associated with its participation in pyrite transformations, but is more complicated than the removal of sulfate. Although rinsing with an organic solvent is in part aimed at removing S0, to the best of our knowledge, the extraction efficiency of S0 in existing protocols has not been assessed. We have developed and tested a new protocol for elemental sulfur removal from the surface of pyrite by ultrasonication with warm acetone. Our data demonstrate the presence of large fractions of S0 on untreated pyrite particle surfaces, of which only approximately 60% was removed by the commonly used pretreatment method. The new protocol described here was found to be more efficient at S0 removal than the commonly used method

  19. Study protocol of a randomized controlled trial comparing integrative body-mind-spirit intervention and cognitive behavioral therapy in fostering quality of life of patients with lung cancer and their family caregivers.

    Science.gov (United States)

    Lau, Bobo Hi-Po; Chow, Amy Y M; Wong, Daniel F K; Chan, Jessie S M; Chan, Celia H Y; Ho, Rainbow T H; So, Tsz-Him; Lam, Tai-Chung; Lee, Victor Ho-Fun; Lee, Anne W M; Chow, Sau Fong; Chan, Cecilia L W

    2018-02-05

    Compared to cancers at other sites, lung cancer often results in greater psychosocial distress to both the patients and their caregivers, due to the poor prognosis and survival rate, as well as the heavy symptom burden. In recent years, making protocols of proposed or on-going studies publicly available via clinical trial registries and/or peer-reviewed journals has benefited health sciences with timely communication of the latest research trends and improved transparency in reporting. However, such practice is yet to be a common sight in evidence-informed social work. Hence, this paper discusses the value of publishing protocols in social work research and presents the protocol of a randomized controlled trial that compares the effectiveness of integrative body-mind-spirit intervention with cognitive behavioral therapy for enhancing quality of life of patients with lung cancer and their family caregivers. The data collection process was still on-going at the time of manuscript submission.

  20. [Colombia 2015 National Mental Health Survey. Study Protocol].

    Science.gov (United States)

    Gómez-Restrepo, Carlos; de Santacruz, Cecilia; Rodriguez, María Nelcy; Rodriguez, Viviana; Tamayo Martínez, Nathalie; Matallana, Diana; Gonzalez, Lina M

    2016-12-01

    The 2015 National Mental Health Survey (NMHS) is the fourth mental survey conducted in Colombia, and is part of the National System of Surveys and Population Studies for health. A narrative description is used to explain the background, references, the preparation, and characteristics of the 2015 NMHS. The 2015 NMHS and its protocol emerge from the requirements that support the national and international policies related to mental health. Together with the Ministry of Health and Social Protection, the objectives, the collection tools, the sample, and the operational plan are defined. The main objective was to obtain updated information about the mental health, mental problems and disorders, accessibility to health services, and an evaluation of health conditions. Participants were inhabitants from both urban and rural areas, over 7 years old, and in whom the comprehension of social determinants and equity were privileged. An observational cross-sectional design with national, regional and age group representativity, was used. The age groups selected were 7-11, 12-17, and over 18 years old. The regions considered were Central, Orient, Atlantic, Pacific, and Bogota. The calculated sample had a minimum of 12,080 and a maximum of 14,496 participants. A brief summary of the protocol of the 2015 NMHS is presented. The full document with all the collection tools can be consulted on the Health Ministry webpage. Copyright © 2016. Publicado por Elsevier España.

  1. 75 FR 17411 - Submission for OMB Review; Comment Request; Women's Health Initiative Observational Study

    Science.gov (United States)

    2010-04-06

    ...), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a... of medical ] history update forms will provide essential data for outcomes assessment for this..., should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission...

  2. Recommended Protocol for Round Robin Studies in Additive Manufacturing

    Science.gov (United States)

    Moylan, Shawn; Brown, Christopher U.; Slotwinski, John

    2016-01-01

    One way to improve confidence and encourage proliferation of additive manufacturing (AM) technologies and parts is by generating more high quality data describing the performance of AM processes and parts. Many in the AM community see round robin studies as a way to generate large data sets while distributing the cost among the participants, thereby reducing the cost to individual users. The National Institute of Standards and Technology (NIST) has conducted and participated in several of these AM round robin studies. While the results of these studies are interesting and informative, many of the lessons learned in conducting these studies concern the logistics and methods of the study and unique issues presented by AM. Existing standards for conducting interlaboratory studies of measurement methods, along with NIST’s experience, form the basis for recommended protocols for conducting AM round robin studies. The role of round robin studies in AM qualification, some of the limitations of round robin studies, and the potential benefit of less formal collaborative experiments where multiple factors, AM machine being only one, are varied simultaneously are also discussed. PMID:27274602

  3. Online Research Output Submission System as a mechanism to influence publication citations: A pilot study

    Directory of Open Access Journals (Sweden)

    Reetha Nundulall

    2017-01-01

    Full Text Available Background: Higher Education Institutions (HEIs need to ensure that the education provided meets the student’s and employer’s requirements, for today and the future. However, in addition to the challenges of teaching and learning, internationalisation, globalisation and world university rankings are rearing their heads thus increasing the demands made on many HEIs.Objective: One of the ways in which HEIs can make their mark is through world university rankings. This may be achieved by exposing more information on new and innovative research knowledge to the broader community in the global market via research publications that attract citations on open access platforms, hence influencing the university’s ranking. For this purpose and intent, a ‘simple’ and ‘easy-to-use’ online web tool was developed at a HEI. The aim was to have research publications submitted via the Online Research Output Submission System (OROSS tool, screened and deposited in the institution’s open access database.Method: Training was provided to the relevant participants and a survey was conducted to ascertain the participants’ perceptions about the utilisation of the OROSS tool and the training provided.Conclusion: This article reflects on the pilot phase of a longitudinal study. Results of an evaluation conducted by the researcher of the OROSS application from a user perspective (process are highlighted. In general, users rated OROSS favourably in terms of it being a useful, simple and easy-to-use web-based tool. The findings of this study may assist University of Johannesburg’s executive management in deciding the fate of the OROSS tool for future use.

  4. Predicting implementation from organizational readiness for change: a study protocol

    National Research Council Canada - National Science Library

    Helfrich, Christian D; Blevins, Dean; Smith, Jeffrey L; Kelly, P Adam; Hogan, Timothy P; Hagedorn, Hildi; Dubbert, Patricia M; Sales, Anne E

    2011-01-01

    ...-documented by organizational scholars, are often ignored in health services research. We describe a protocol to comprehensively assess the psychometric properties of a previously developed survey, the Organizational Readiness to Change Assessment...

  5. Inconsistent Reporting Between Meta-analysis Protocol and Publication - A Cross-Sectional Study.

    Science.gov (United States)

    Delgado, Alberto Falk; Delgado, Anna Falk

    2017-09-01

    Inconsistent reporting in published meta-analyses compared to registered protocol are poorly understood. The aim of the study was to assess inconsistencies between registered protocols and published reports among oncology drug meta-analyses. A cross-sectional study was performed including oncology drug meta-analyses published between January 1st and November 14th 2016 with a published protocol. Two investigators extracted data on: selection criteria, outcome(s) and statistical plan in protocol and manuscript, plus self-acknowledgement of inconsistent reporting between protocol and publication. Protocol registration was present in 19% (23/119) of all oncology drug meta-analyses. In meta-analyses with protocol (n=23), 70% (16/23) had issues with inconsistent reporting between protocol and published report concerning; inclusion criteria, comparator group, intervention, outcome (PICO) or statistical analysis. Self-acknowledgement of changes between protocol and publication was found in 50% (8/16). In meta-analyses with protocol, discrepancies between registered protocols and publications are frequent. Copyright© 2017, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.

  6. Presynchronization using a modified Ovsynch protocol or a single gonadotropin-releasing hormone injection 7 d before an Ovsynch-56 protocol for submission of lactating dairy cows to first timed artificial insemination.

    Science.gov (United States)

    Carvalho, P D; Guenther, J N; Fuenzalida, M J; Amundson, M C; Wiltbank, M C; Fricke, P M

    2014-10-01

    Presynchronization strategies, such as Presynch-Ovsynch and Double-Ovsynch, increase fertility to timed artificial insemination (TAI) compared with Ovsynch alone; however, simpler presynchronization strategies could reduce costs and simplify reproductive management. Lactating Holstein cows (n=601) were randomly assigned to 1 of 2 presynchronization treatments before beginning an Ovsynch-56 protocol (GnRH at 70 ± 3 DIM, PGF2α 7 d later, GnRH 56 h after PGF2α, and TAI 16 h later at 80 ± 3 DIM) for first TAI. Cows (n=306) in the first treatment (Double-Ovsynch; DO) were presynchronized using a modified Ovsynch protocol (GnRH at 53 ± 3 DIM, 7 d later PGF2α, and GnRH 3 d later) ending 7 d before the first GnRH injection (G1) of an Ovsynch-56 protocol. Cows (n=295) in the second treatment (GGPG) were presynchronized using a single injection of GnRH 7 d before G1 of an Ovsynch-56 protocol at 63 ± 3 DIM. Blood samples were collected at G1 and the PGF2α injections of the Ovsynch-56 protocol to determine progesterone (P4) concentrations. Pregnancy diagnosis was performed using ultrasonography 32 d after TAI, and pregnant cows were reexamined 46 and 70 d after TAI. Overall, DO cows had more pregnancies per artificial insemination (P/AI) compared with GGPG cows 32 d after TAI (53 vs. 43%). Overall, P/AI did not differ by parity (primiparous vs. multiparous), and pregnancy loss did not differ between treatments or parities. More DO cows had P4 in a medium range (>0.5 to 4 ng/mL) at the PGF2α injection of the Ovsynch-56 protocol compared with GGPG cows (67 vs. 36%). Thus, presynchronization with a modified Ovsynch protocol increased P/AI after TAI at first AI by increasing synchrony to the Ovsynch-56 protocol compared with presynchronization using a single injection of GnRH. Copyright © 2014 American Dairy Science Association. Published by Elsevier Inc. All rights reserved.

  7. The effects of a regional telepathology project: a study protocol

    Directory of Open Access Journals (Sweden)

    Trudel Marie-Claude

    2012-03-01

    Full Text Available Abstract Background Telepathology, which is an emerging form of telemedicine in Canada, is defined as the electronic transmission of pathological images, usually derived from microscopes, from one location to another. There are various applications of telepathology, including case referral for an expert opinion, provision of an emergency service in the absence of a resident pathologist, and education. Until now, there has been relatively little use of telepathology for core diagnostic services in the absence of a local pathologist, but this practice is likely to increase in the future. The Laval University Integrated Health Network is in the process of deploying a telepathology system, primarily to provide an intraoperative frozen section service to small hospitals in sparsely populated areas which are experiencing a severe shortage of on-site pathologists. The telepathology project involves 17 hospitals located in five regions of eastern Quebec, Canada. This paper describes the study protocol that will be used to evaluate the benefits associated with the project. Methods/Design A panel of experts was first assembled by Canada Health Infoway to agree on a set of benefits indicators that could be applied to all telepathology projects across Canada. Using the set of indicators as an input, we have developed a three-step study protocol. First, a survey questionnaire will be distributed to appraise the way pathologists, pathology technologists and surgeons perceive the telepathology system and its impacts. Second, a series of semi-structured interviews will be conducted with project leaders and telepathology users at sites that are representative of all the hospitals in the Laval University Integrated Health Network. The overall aim is to better understand the expected and unexpected effects of telepathology on health care professionals and patients as well as on the regional organization and delivery of care services. Finally, a pre-post design

  8. Protocol matters: which methylome are you actually studying?

    Science.gov (United States)

    Robinson, Mark D; Statham, Aaron L; Speed, Terence P; Clark, Susan J

    2011-01-01

    The field of epigenetics is now capitalizing on the vast number of emerging technologies, largely based on second-generation sequencing, which interrogate DNA methylation status and histone modifications genome-wide. However, getting an exhaustive and unbiased view of a methylome at a reasonable cost is proving to be a significant challenge. In this article, we take a closer look at the impact of the DNA sequence and bias effects introduced to datasets by genome-wide DNA methylation technologies and where possible, explore the bioinformatics tools that deconvolve them. There remains much to be learned about the performance of genome-wide technologies, the data we mine from these assays and how it reflects the actual biology. While there are several methods to interrogate the DNA methylation status genome-wide, our opinion is that no single technique suitably covers the minimum criteria of high coverage and, high resolution at a reasonable cost. In fact, the fraction of the methylome that is studied currently depends entirely on the inherent biases of the protocol employed. There is promise for this to change, as the third generation of sequencing technologies is expected to again ‘revolutionize’ the way that we study genomes and epigenomes. PMID:21566704

  9. The Tehran Eye Study: research design and eye examination protocol

    Directory of Open Access Journals (Sweden)

    Fotouhi Akbar

    2003-07-01

    Full Text Available Abstract Background Visual impairment has a profound impact on society. The majority of visually impaired people live in developing countries, and since most disorders leading to visual impairment are preventable or curable, their control is a priority in these countries. Considering the complicated epidemiology of visual impairment and the wide variety of factors involved, region specific intervention strategies are required for every community. Therefore, providing appropriate data is one of the first steps in these communities, as it is in Iran. The objectives of this study are to describe the prevalence and causes of visual impairment in the population of Tehran city; the prevalence of refractive errors, lens opacity, ocular hypertension, and color blindness in this population, and also the familial aggregation of refractive errors, lens opacity, ocular hypertension, and color blindness within the study sample. Methods Design Through a population-based, cross-sectional study, a total of 5300 Tehran citizens will be selected from 160 clusters using a stratified cluster random sampling strategy. The eligible people will be enumerated through a door-to-door household survey in the selected clusters and will be invited. All participants will be transferred to a clinic for measurements of uncorrected, best corrected and presenting visual acuity; manifest, subjective and cycloplegic refraction; color vision test; Goldmann applanation tonometry; examination of the external eye, anterior segment, media, and fundus; and an interview about demographic characteristics and history of eye diseases, eye trauma, diabetes mellitus, high blood pressure, and ophthalmologic cares. The study design and eye examination protocol are described. Conclusion We expect that findings from the TES will show the status of visual problems and their causes in the community. This study can highlight the people who should be targeted by visual impairment prevention programs.

  10. Comparative Study on Various Authentication Protocols in Wireless Sensor Networks

    Science.gov (United States)

    Rajeswari, S. Raja; Seenivasagam, V.

    2016-01-01

    Wireless sensor networks (WSNs) consist of lightweight devices with low cost, low power, and short-ranged wireless communication. The sensors can communicate with each other to form a network. In WSNs, broadcast transmission is widely used along with the maximum usage of wireless networks and their applications. Hence, it has become crucial to authenticate broadcast messages. Key management is also an active research topic in WSNs. Several key management schemes have been introduced, and their benefits are not recognized in a specific WSN application. Security services are vital for ensuring the integrity, authenticity, and confidentiality of the critical information. Therefore, the authentication mechanisms are required to support these security services and to be resilient to distinct attacks. Various authentication protocols such as key management protocols, lightweight authentication protocols, and broadcast authentication protocols are compared and analyzed for all secure transmission applications. The major goal of this survey is to compare and find out the appropriate protocol for further research. Moreover, the comparisons between various authentication techniques are also illustrated. PMID:26881272

  11. Protocol for fir tree sampling for provenance studies

    Science.gov (United States)

    Meisel, Thomas; Bandoniene, Donata; Zettl, Daniela

    2014-05-01

    Isotopic (stable and radiogenic) as well as trace element fingerprinting methods used for tracing the geographical origin, rely on databases, that need to contain data sets representative of the measurands of the individual samples for a specific geographic entity. Through this work, we want to assess different sampling strategies for obtaining representative sample of fir trees (Abies sp.). Motivation for this work is the protection of the local Austrian Christmas tree market from wrongly tagged trees of non-Austrian origin. In particular, we studied three typical Christmas trees the most common species sold as Christmas tree, namely Abies nordmanniana (Nordmann Fir), from the same locality in lower Austria. For the initial tests we applied the elemental fingerprinting method, to study the suitability of the different parts of the tree applying ICP-MS analysis after complete acid digestion in a high pressure asher system (HPA-S).Needle samples from each year of life of the tree and stem wood from three different heights were analyzed for their trace element content to prove the repeatability and to find the best sampling protocol. For the analysis of the needles, the natural wax coating had to be removed in order to get reproducible results. For the analysis of stem wood only the bark was removed. As expected the data of all three trees allowed the differentiation of the individual needle ages, but interestingly enough also between the three sampling heights of the needs. Both needles and wood proved to be suitable for successful fingerprinting, but importantly, provided that sample of the same type and ages are compared. The same samples for the three trees will also be used for isotopic analysis studies to better understand the influence of age and sampling height on the representativeness of fir tree samples. Based on elemental fingerprinting alone, a successful discrimination between local (Austrian) and foreign (Danish, Irish) Christmas trees was possible.

  12. Hypertension Improvement Project (HIP: study protocol and implementation challenges

    Directory of Open Access Journals (Sweden)

    Pollak Kathryn I

    2009-02-01

    Full Text Available Abstract Background Hypertension affects 29% of the adult U.S. population and is a leading cause of heart disease, stroke, and kidney failure. Despite numerous effective treatments, only 53% of people with hypertension are at goal blood pressure. The chronic care model suggests that blood pressure control can be achieved by improving how patients and physicians address patient self-care. Methods and design This paper describes the protocol of a nested 2 × 2 randomized controlled trial to test the separate and combined effects on systolic blood pressure of a behavioral intervention for patients and a quality improvement-type intervention for physicians. Primary care practices were randomly assigned to the physician intervention or to the physician control condition. Physician randomization occurred at the clinic level. The physician intervention included training and performance monitoring. The training comprised 2 internet-based modules detailing both the JNC-7 hypertension guidelines and lifestyle modifications for hypertension. Performance data were collected for 18 months, and feedback was provided to physicians every 3 months. Patient participants in both intervention and control clinics were individually randomized to the patient intervention or to usual care. The patient intervention consisted of a 6-month behavioral intervention conducted by trained interventionists in 20 group sessions, followed by 12 monthly phone contacts by community health advisors. Follow-up measurements were performed at 6 and 18 months. The primary outcome was the mean change in systolic blood pressure at 6 months. Secondary outcomes were diastolic blood pressure and the proportion of patients with adequate blood pressure control at 6 and 18 months. Discussion Overall, 8 practices (4 per treatment group, 32 physicians (4 per practice; 16 per treatment group, and 574 patients (289 control and 285 intervention were enrolled. Baseline characteristics of patients and

  13. Identifying multiple submissions in Internet research: preserving data integrity.

    Science.gov (United States)

    Bowen, Anne M; Daniel, Candice M; Williams, Mark L; Baird, Grayson L

    2008-11-01

    Internet-based sexuality research with hidden populations has become increasingly popular. Respondent anonymity may encourage participation and lower social desirability, but associated disinhibition may promote multiple submissions, especially when incentives are offered. The goal of this study was to identify the usefulness of different variables for detecting multiple submissions from repeat responders and to explore incentive effects. The data included 1,900 submissions from a three-session Internet intervention with a pretest and three post-test questionnaires. Participants were men who have sex with men and incentives were offered to rural participants for completing each questionnaire. The final number of submissions included 1,273 "unique", 132 first submissions by "repeat responders" and 495 additional submissions by the "repeat responders" (N = 1,900). Four categories of repeat responders were identified: "infrequent" (2-5 submissions), "persistent" (6-10 submissions), "very persistent" (11-30 submissions), and "hackers" (more than 30 submissions). Internet Provider (IP) addresses, user names, and passwords were the most useful for identifying "infrequent" repeat responders. "Hackers" often varied their IP address and identifying information to prevent easy identification, but investigating the data for small variations in IP, using reverse telephone look up, and patterns across usernames and passwords were helpful. Incentives appeared to play a role in stimulating multiple submissions, especially from the more sophisticated "hackers". Finally, the web is ever evolving and it will be necessary to have good programmers and staff who evolve as fast as "hackers".

  14. Partner randomized controlled trial: study protocol and coaching intervention

    Directory of Open Access Journals (Sweden)

    Garbutt Jane M

    2012-04-01

    Full Text Available Abstract Background Many children with asthma live with frequent symptoms and activity limitations, and visits for urgent care are common. Many pediatricians do not regularly meet with families to monitor asthma control, identify concerns or problems with management, or provide self-management education. Effective interventions to improve asthma care such as small group training and care redesign have been difficult to disseminate into office practice. Methods and design This paper describes the protocol for a randomized controlled trial (RCT to evaluate a 12-month telephone-coaching program designed to support primary care management of children with persistent asthma and subsequently to improve asthma control and disease-related quality of life and reduce urgent care events for asthma care. Randomization occurred at the practice level with eligible families within a practice having access to the coaching program or to usual care. The coaching intervention was based on the transtheoretical model of behavior change. Targeted behaviors included 1 effective use of controller medications, 2 effective use of rescue medications and 3 monitoring to ensure optimal control. Trained lay coaches provided parents with education and support for asthma care, tailoring the information provided and frequency of contact to the parent's readiness to change their child's day-to-day asthma management. Coaching calls varied in frequency from weekly to monthly. For each participating family, follow-up measurements were obtained at 12- and 24-months after enrollment in the study during a telephone interview. The primary outcomes were the mean change in 1 the child's asthma control score, 2 the parent's quality of life score, and 3 the number of urgent care events assessed at 12 and 24 months. Secondary outcomes reflected adherence to guideline recommendations by the primary care pediatricians and included the proportion of children prescribed controller medications

  15. Assessment of the quality and quantity of drug-drug interaction studies in recent NDA submissions: study design and data analysis issues.

    Science.gov (United States)

    Huang, S M; Lesko, L J; Williams, R L

    1999-10-01

    This report investigates the quality and quantity of drug-drug interaction studies in recent new drug applications (NDAs). Eighty-nine studies contained in 14 NDAs submitted between December 1995 and November 1996 to the U.S. Food and Drug Administration (FDA) were reviewed. The results indicated that the median number of clinical drug-drug interaction studies per NDA was 6, almost double that of a 1994-1995 survey. In vitro metabolism data were present in 70% of the submissions. More than 50% of the submissions contained interaction studies using a battery of drugs (cimetidine, digoxin, or warfarin) without optimal use of the in vitro metabolism or in vivo mass balance data. Various study designs using a median number of 12 subjects were employed in the evaluation of drug-drug interactions. Some of the important study design factors such as dose size, dosing regimen, dosing duration, and timing of coadministration were considered, although not consistently, by the sponsors in their study design. Seventy-five percent of the studies used normal, healthy male subjects, and 25% used patients for whom the new molecular entities were intended. In 33% of the studies, female subjects were also recruited. Although the majority (80%) of the submissions still used p-values to determine the significance of drug interactions, 30% used a more relevant equivalence approach with 90% confidence intervals for key pharmacokinetic and/or pharmacodynamic parameter ratios to assess the extent of drug interactions. Overall, 82% of the studies concluded no interaction. Although population pharmacokinetic analysis can be a useful tool in studying drug-drug interactions, only 21% of the submissions used this approach. In summary, this assessment reveals that the quantity and quality of drug-drug interaction studies in NDAs have improved over the years. These improvements, as well as others that can be implemented, should result in more informative labeling and better patient care. FDA

  16. The bakery protocol : a comparitive case-study in formal verification

    NARCIS (Netherlands)

    W.O.D. Griffioen; H.P. Korver

    1995-01-01

    textabstractA Comparative Case-Study in Formal Verification Groote and the second author verified (a version of) the Bakery Protocol in $muCRL$. Their process-algebraic verification is rather complex compared to the protocol. Now the question is: How do other verification techniques perform on this

  17. Pilot studies for the North American Soil Geochemical Landscapes Project - Site selection, sampling protocols, analytical methods, and quality control protocols

    Science.gov (United States)

    Smith, D.B.; Woodruff, L.G.; O'Leary, R. M.; Cannon, W.F.; Garrett, R.G.; Kilburn, J.E.; Goldhaber, M.B.

    2009-01-01

    In 2004, the US Geological Survey (USGS) and the Geological Survey of Canada sampled and chemically analyzed soils along two transects across Canada and the USA in preparation for a planned soil geochemical survey of North America. This effort was a pilot study to test and refine sampling protocols, analytical methods, quality control protocols, and field logistics for the continental survey. A total of 220 sample sites were selected at approximately 40-km intervals along the two transects. The ideal sampling protocol at each site called for a sample from a depth of 0-5 cm and a composite of each of the O, A, and C horizons. The analysis, the USGS QC officer, and the principal investigator for the study. This level of review resulted in an average of one QC sample for every 20 field samples, which proved to be minimally adequate for such a large-scale survey. Additional QC samples should be added to monitor within-batch quality to the extent that no more than 10 samples are analyzed between a QC sample. Only Cr (77%), Y (82%), and Sb (80%) fell outside the acceptable limits of accuracy (% recovery between 85 and 115%) because of likely residence in mineral phases resistant to the acid digestion. A separate sample of 0-5-cm material was collected at each site for determination of organic compounds. A subset of 73 of these samples was analyzed for a suite of 19 organochlorine pesticides by gas chromatography. Only three of these samples had detectable pesticide concentrations. A separate sample of A-horizon soil was collected for microbial characterization by phospholipid fatty acid analysis (PLFA), soil enzyme assays, and determination of selected human and agricultural pathogens. Collection, preservation and analysis of samples for both organic compounds and microbial characterization add a great degree of complication to the sampling and preservation protocols and a significant increase to the cost for a continental-scale survey. Both these issues must be

  18. A focused ethnographic study of Alberta cattle veterinarians' decision making about diagnostic laboratory submissions and perceptions of surveillance programs.

    Directory of Open Access Journals (Sweden)

    Kate Sawford

    Full Text Available The animal and public health communities need to address the challenge posed by zoonotic emerging infectious diseases. To minimize the impacts of future events, animal disease surveillance will need to enable prompt event detection and response. Diagnostic laboratory-based surveillance systems targeting domestic animals depend in large part on private veterinarians to submit samples from cases to a laboratory. In contexts where pre-diagnostic laboratory surveillance systems have been implemented, this group of veterinarians is often asked to input data. This scenario holds true in Alberta where private cattle veterinarians have been asked to participate in the Alberta Veterinary Surveillance Network-Veterinary Practice Surveillance, a platform to which pre-diagnostic disease and non-disease case data are submitted. Consequently, understanding the factors that influence these veterinarians to submit cases to a laboratory and the complex of factors that affect their participation in surveillance programs is foundational to interpreting disease patterns reported by laboratories and engaging veterinarians in surveillance. A focused ethnographic study was conducted with ten cattle veterinarians in Alberta. Individual in-depth interviews with participants were recorded and transcribed to enable thematic analysis. Laboratory submissions were biased toward outbreaks of unknown cause, cases with unusual mortality rates, and issues with potential herd-level implications. Decreasing cattle value and government support for laboratory testing have contributed to fewer submissions over time. Participants were willing participants in surveillance, though government support and collaboration were necessary. Changes in the beef industry and veterinary profession, as well as cattle producers themselves, present both challenges and opportunities in surveillance.

  19. Research Protocol for Systematic Review and Meta-Analysis of Elder Abuse Prevalence Studies.

    Science.gov (United States)

    Yon, Yongjie; Mikton, Christopher; Gassoumis, Zachary D; Wilber, Kathleen H

    2017-06-01

    Elder abuse is an important public health and human rights issue, yet its true extent is not well understood. To address this, we will conduct a systematic review and meta-analysis of elder abuse prevalence studies from around the world. This protocol describes the methodological approach to be adopted for conducting this systematic review and meta-analysis. In particular, the protocol describes the search strategies and eligibility criteria to be used to identify and select studies and how data from the selected studies will be extracted for analysis. The protocol also describes the analytical approach that will be used to calculate pooled prevalence estimates and discusses the use of meta-regression to assess how studies' characteristics influence the prevalence estimates. This protocol conforms to the Preferred Reporting Items for Systematic reviews and Meta-Analysis - or PRISMA - guidelines and has been registered with the PROSPERO International Prospective Register of systematic reviews.

  20. Nigerian Journal of Technology: Submissions

    African Journals Online (AJOL)

    This article acts as the template for preparing articles for submission to Nigerian Journal of Technology. The abstract should be a clear statement defining the problems of study, methodology adopted, results and conclusions. Please do not refer readers to other literature articles in the abstract. The abstract should be brief ...

  1. Shakespeare in Southern Africa: Submissions

    African Journals Online (AJOL)

    Author Guidelines. Shakespeare in Southern Africa sets out to publish articles, commentary and reviews on all aspects of Shakespearean studies and performance, with a particular emphasis on the response to Shakespeare in southern Africa. Scholarly notes of a factual nature are also welcome. Submissions are reviewed ...

  2. Guilt, fear, submission, and empathy in depression.

    Science.gov (United States)

    O'Connor, Lynn E; Berry, Jack W; Weiss, Joseph; Gilbert, Paul

    2002-09-01

    This study compares self-focused motivations (fear of negative evaluation, social comparison, and fear of envy) and other-focused motivations (empathy and interpersonal guilt) in submissive behavior and depression. The Beck Depression Inventory, Submissive Behavior Scale, Fear of Negative Evaluation Scale, Social Comparison Scale, Interpersonal Guilt Questionnaire, and Interpersonal Reactivity Inventory were administered to 50 patients hospitalized for depression and 52 students. Depressed patients were significantly higher in survivor guilt, omnipotent responsibility guilt, submissive behavior, fear of negative evaluation, fear of envy, and empathic distress, and lower in social comparison. This research was limited in that it was a correlational study. This study suggests that altruistic concern about others may be an important factor in depression and submissive behavior. Evolutionary implications of these findings are discussed.

  3. A comparative study of luteal estradiol pre-treatment in GnRH antagonist protocols and in micro dose flare protocols for poor-responding patients.

    Science.gov (United States)

    Davar, Robab; Rahsepar, Mozhgan; Rahmani, Elham

    2013-01-01

    This study aims to verify if luteal estradiol pre-treatment improves IVF/ICSI outcomes in a GnRH antagonist protocol as compared with a micro dose GnRH agonist protocol in poor-responding patients. A total of 116 IVF/ICSI cycles were included in this prospective randomized single blind clinical trial. The selected women were randomly assigned to receive an estradiol pre-treatment in a GnRH antagonist protocol (daily oral Estradiol Valerate 4 mg preceding the IVF cycle from the 21st day until the first day of the next cycle) or in oral contraceptive pill micro dose GnRH agonist protocol. The patients in the luteal estradiol protocol required more days of stimulation (10.9 ± 1.6 vs. 10.2 ± 1.8) and a greater gonadotropin requirement (3,247.8 ± 634.6 vs. 2,994.8 ± 611 IU), yet similar numbers of oocytes were retrieved and fertilized. There was no significant difference between the two groups in terms of the implantation rates (9.8 vs. 7.9 %) and the clinical pregnancy rates per transfer (16.3 vs. 15.6 %). This study demonstrates that the use of estradiol during a preceding luteal phase in a GnRH antagonist protocol can provide similar IVF outcomes when compared to a micro dose GnRH agonist protocol.

  4. Training oncology nurses to use remote symptom support protocols: a retrospective pre-/post study.

    Science.gov (United States)

    Stacey, Dawn; Skrutkowski, Myriam; Carley, Meg; Kolari, Erin; Shaw, Tara; Ballantyne, Barbara

    2015-03-01

    To evaluate the impact of training on nurses' satisfaction and perceived confidence using symptom protocols for remotely supporting patients undergoing cancer treatment. Retrospective pre-/post-study guided by the Knowledge-to-Action Framework. Interactive workshops at three ambulatory oncology programs in Canada. 107 RNs who provide remote support to patients with cancer. Workshops included didactic presentation, role play with protocols, and group discussion. Post-training, a survey measured satisfaction with training and retrospective pre-/post-perceived confidence in the ability to provide symptom support using protocols. One-tailed, paired t-tests measured change. Satisfaction with the workshop and perceived confidence in the ability to provide symptom support and use protocols. Twenty-two workshops, 30-60 minutes each, were conducted with 107 participants. Ninety completed the survey. Compared to preworkshop, postworkshop nurses had improved self-confidence to assess, triage, and guide patients in self-care for cancer treatment-related symptoms, and use protocols to facilitate symptom assessment, triage, and care. Workshops were rated as easy to understand, comprehensive, and provided new information on remote symptom management. Some specified that the workshop did not provide enough time for role play, but most said they would recommend it to others. The workshop increased nurses' perceived confidence with providing remote symptom support and was well received. Subsequent workshops should ensure adequate time for role play to enhance nurses' skills in using protocols and documenting symptom support.

  5. Protocol Coordinator II | Center for Cancer Research

    Science.gov (United States)

    Provides programmatic and logistical support for the operations of clinical research for Phase I and Phase II clinical trials Provides deployment of clinical support services for clinical research  Streamlines protocol development timeline Provides data and document collection and compilation for regulatory filing with the FDA and other regulatory authorities Provides technical review and report preparation Provides administrative coordination and general logistical support for regulatory activities Ensures the provision of training for investigators and associate staff to reinforce and enhance a GCP culture Provides quality assurance and quality control oversight Performs regulatory review of clinical protocols, informed consent and other clinical documents  Tracks and facilitates a portfolio of protocols through each process step (IRB, RAC, DSMB, Office of Protocol Services) Assists clinical investigators in preparing clinical research protocols, including writing and formatting protocol documents and consent forms Prepares protocol packages for review and ensures that protocol packages include all the required material and comply with CCR, NCI and NIH policies Collaborates with investigators to resolve any protocol/data issues Coordinates submission of protocols for scientific and ethical review by the Branch scientific review committees, the NCI Institutional Review Board (IRB) and the clinical trial sponsor or the FDA Monitors the review process and maintains detailed, complete and accurate records for each protocol of the approvals at the various stages of the review process, including new protocol submissions, amendments to protocols, and continuing reviews, as well as other submissions such as adverse events Attends and prepares minutes for the Branch Protocol Review Committees For protocols that are performed with other research centers: contacts coordinators at other centers to obtain review committee approvals at these centers,  maintains records of

  6. Protocol: optimisation of a grafting protocol for oilseed rape (Brassica napus) for studying long-distance signalling.

    Science.gov (United States)

    Ostendorp, Anna; Pahlow, Steffen; Deke, Jennifer; Thieß, Melanie; Kehr, Julia

    2016-01-01

    Grafting is a well-established technique for studying long-distance transport and signalling processes in higher plants. While oilseed rape has been the subject of comprehensive analyses of xylem and phloem sap to identify macromolecules potentially involved in long-distance information transfer, there is currently no standardised grafting method for this species published. We developed a straightforward collar-free grafting protocol for Brassica napus plants with high reproducibility and success rates. Micrografting of seedlings was done on filter paper. Grafting success on different types of regeneration media was measured short-term after grafting and as the long-term survival rate (>14 days) of grafts after the transfer to hydroponic culture or soil. We compared different methods for grafting B. napus seedlings. Grafting on filter paper with removed cotyledons, a truncated hypocotyl and the addition of low levels of sucrose under long day conditions allowed the highest grafting success. A subsequent long-term hydroponic cultivation of merged grafts showed highest survival rates and best reproducibility.

  7. Health effects of smoke from planned burns: a study protocol

    Directory of Open Access Journals (Sweden)

    David O’Keeffe

    2016-02-01

    Full Text Available Abstract Background Large populations are exposed to smoke from bushfires and planned burns. Studies investigating the association between bushfire smoke and health have typically used hospital or ambulance data and been done retrospectively on large populations. The present study is designed to prospectively assess the association between individual level health outcomes and exposure to smoke from planned burns. Methods/design A prospective cohort study will be conducted during a planned burn season in three locations in Victoria (Australia involving 50 adult participants who undergo three rounds of cardiorespiratory medical tests, including measurements for lung inflammation, endothelial function, heart rate variability and markers of inflammation. In addition daily symptoms and twice daily lung function are recorded. Outdoor particulate air pollution is continuously measured during the study period in these locations. The data will be analysed using mixed effect models adjusting for confounders. Discussion Planned burns depend on weather conditions and dryness of ‘fuels’ (i.e. forest. It is potentially possible that no favourable conditions occur during the study period. To reduce the risk of this occurring, three separate locations have been identified as having a high likelihood of planned burn smoke exposure during the study period, with the full study being rolled out in two of these three locations. A limitation of this study is exposure misclassification as outdoor measurements will be conducted as a measure for personal exposures. However this misclassification will be reduced as participants are only eligible if they live in close proximity to the monitors.

  8. Pregnancy outcome of “delayed start” GnRH antagonist protocol versus GnRH antagonist protocol in poor responders: A clinical trial study

    Directory of Open Access Journals (Sweden)

    Abbas Aflatoonian

    2017-08-01

    Full Text Available Background: Management of poor-responding patients is still major challenge in assisted reproductive techniques (ART. Delayed-start GnRH antagonist protocol is recommended to these patients, but little is known in this regards. Objective: The goal of this study was assessment of delayed-start GnRH antagonist protocol in poor responders, and in vitro fertilization (IVF outcomes. Materials and Methods: This randomized clinical trial included sixty infertile women with Bologna criteria for ovarian poor responders who were candidate for IVF. In case group (n=30, delayed-start GnRH antagonist protocol administered estrogen priming followed by early follicular-phase GnRH antagonist treatment for 7 days before ovarian stimulation with gonadotropin. Control group (n=30 treated with estrogen priming antagonist protocol. Finally, endometrial thickness, the rates of oocytes maturation, , embryo formation, and pregnancy were compared between two groups. Results: Rates of implantation, chemical, clinical, and ongoing pregnancy in delayed-start cycles were higher although was not statistically significant. Endometrial thickness was significantly higher in case group. There were no statistically significant differences in the rates of oocyte maturation, embryo formation, and IVF outcomes between two groups. Conclusion: There is no significant difference between delayed-start GnRH antagonist protocol versus GnRH antagonist protocol.

  9. Sarcopenia and its determinants among Iranian elderly (SARIR: study protocol

    Directory of Open Access Journals (Sweden)

    Hashemi Rezvan

    2012-11-01

    Full Text Available Abstract Background The elderly populations increase in world because of improved health status in communities, so health and independency of seniors has become and will be one of the main priorities of public health systems. Ageing have been associated with changes in body composition, including loss of muscle mass, loss of bone mass and increase fat mass. Involuntary age related loss of muscle mass, sarcopenia,has been linked to functional impairment and physical disability. Several definitions for sarcopenia have been presented based on the method of measuring body composition, but an internationally accepted definition doesn’t presently exist yet. In 2010, the European working group on sarcopenia developed a new definition for sarcopenia according to measure muscle mass and muscle function. Several studies have been done about sarcopenia in world, but to our knowledge this study is the first in Iran which is one of the largest countries of the Middle East that faces a fast growing elderly population. The aim of this study is to evaluate sarcopenia and related risk factors in Iran according new definition of sarcopenia. Methods This study will be conducted in two phase among elderly men and women over 55 years in the 6th district of TehranThe first phase will be a population-based cross-sectional study to determine the frequency of sarcopenia in the study population, and to conduct case finding for the second phase. The second phase will be a case–control study to comparison the metabolic and inflammatory factors in sarcopenic and non sarcopenic groups. The association between sarcopenia and major dietary pattern will be evaluated using factor analysis. Conclusion This study is the first study that evaluates sarcopenia and its risk factor in Iranian elderlies. We discuss details of how we collect the data and appropriate instruments to measure muscle mass, muscle power and muscle strength, and suitable cut- off to define sarcopenia in

  10. Study Protocol: insulin and its role in cancer.

    Science.gov (United States)

    Harish, K; Dharmalingam, M; Himanshu, M

    2007-10-22

    Studies have shown that metabolic syndrome and its consequent biochemical derangements in the various phases of diabetes may contribute to carcinogenesis. A part of this carcinogenic effect could be attributed to hyperinsulinism. High levels of insulin decrease the production of IGF-1 binding proteins and hence increase levels of free IGF-1. It is well established that bioactivity of free insulin growth factor 1 (IGF-1) increases tumor turnover rate. The objective is to investigate the role of insulin resistance/sensitivity in carcinogenesis by studying the relation between insulin resistance/sensitivity and IGF-1 levels in cancer patients. We postulate that hyperinsulinaemia which prevails during initial phases of insulin resistance (condition prior to overt diabetes) increases bioactivity of free IGF-1, which may contribute to process of carcinogenesis. Based on our pilot study results and power analysis of the same, we have designed a two group case-control study. 800 proven untreated cancer patients (solid epithelial cell tumors) under age of 50 shall be recruited with 200 healthy subjects serving as controls. Insulin resistance/sensitivity and free IGF-1 levels shall be determined in all subjects. Association between the two parameters shall be tested using suitable statistical methods. Well controlled studies in humans are essential to study the link between insulin resistance, hyperinsulinaemia, IGF-1 and carcinogenesis. This study could provide insights to the role of insulin, insulin resistance, IGF-1 in carcinogenesis although a precise role and the extent of influence cannot be determined. In future, cancer prevention and treatment strategies could revolve around insulin and insulin resistance.

  11. Perspectives in Education: Submissions

    African Journals Online (AJOL)

    Author Guidelines. Guidelines to authors can be found on the journal's own site here: http://www.perspectives-in-education.com/pages.aspx?PID=10. Alternatively, see below: Information for Authors. Submission of articles. PiE invites submissions in the following categories: Research articles. Contributors are encouraged to ...

  12. Mizan Law Review: Submissions

    African Journals Online (AJOL)

    Author Guidelines. SUBMISSION GUIDELINES The following submissions are acceptable for publication upon approval by the Editorial Board. Publication of an article further involves anonymous peer review by two External Assessors. Articles: Research articles that identify, examine, explore and analyze legal and related ...

  13. The Siblings With Ischemic Stroke Study (SWISS Protocol

    Directory of Open Access Journals (Sweden)

    Hardy John

    2002-02-01

    Full Text Available Abstract Background Family history and twins studies suggest an inherited component to ischemic stroke risk. Candidate gene association studies have been performed but have limited capacity to identify novel risk factor genes. The Siblings With Ischemic Stroke Study (SWISS aims to conduct a genome-wide scan in sibling pairs concordant or discordant for ischemic stroke to identify novel genetic risk factors through linkage analysis. Methods Screening at multiple clinical centers identifies patients (probands with radiographically confirmed ischemic stroke and a family history of at least 1 living full sibling with stroke. After giving informed consent, without violating privacy among other family members, the proband invites siblings concordant and discordant for stroke to participate. Siblings then contact the study coordinating center. The diagnosis of ischemic stroke in potentially concordant siblings is confirmed by systematic centralized review of medical records. The stroke-free status of potentially discordant siblings is confirmed by validated structured telephone interview. Blood samples for DNA analysis are taken from concordant sibling pairs and, if applicable, from 1 discordant sibling. Epstein-Barr virus-transformed lymphoblastoid cell lines are created, and a scan of the human genome is planned. Discussion Conducting adequately powered genomics studies of stroke in humans is challenging because of the heterogeneity of the stroke phenotype and the difficulty of obtaining DNA samples from clinically well-characterized members of a cohort of stroke pedigrees. The multicentered design of this study is intended to efficiently assemble a cohort of ischemic stroke pedigrees without invoking community consent or using cold-calling of pedigree members.

  14. Protocol: using virus-induced gene silencing to study the arbuscular mycorrhizal symbiosis in Pisum sativum

    DEFF Research Database (Denmark)

    Grønlund, Mette; Olsen, Anne; Johansen, Elisabeth

    2010-01-01

    Virus-induced gene silencing (VIGS) is an alternative reverse genetics tool for silencing of genes in some plants, which are difficult to transform. The pea early-browning virus (PEBV) has been developed as a VIGS vector and used in pea for functional analysis of several genes. However......, the available PEBV-VIGS protocols are inadequate for studying genes involved in the symbiosis with arbuscular mycorrhizal fungi (AMF). Here we describe a PEBV-VIGS protocol suitable for reverse genetics studies in pea of genes involved in the symbiosis with AMF and show its effectiveness in silencing genes...

  15. EVA Human Health and Performance Benchmarking Study Overview and Development of a Microgravity Protocol

    Science.gov (United States)

    Norcross, Jason; Jarvis, Sarah; Bekdash, Omar; Cupples, Scott; Abercromby, Andrew

    2017-01-01

    The primary objective of this study is to develop a protocol to reliably characterize human health and performance metrics for individuals working inside various EVA suits under realistic spaceflight conditions. Expected results and methodologies developed during this study will provide the baseline benchmarking data and protocols with which future EVA suits and suit configurations (e.g., varied pressure, mass, center of gravity [CG]) and different test subject populations (e.g., deconditioned crewmembers) may be reliably assessed and compared. Results may also be used, in conjunction with subsequent testing, to inform fitness-for-duty standards, as well as design requirements and operations concepts for future EVA suits and other exploration systems.

  16. Case Study: Applying the Theory of Planned Behavior as Interventions to Increase Sponsored Project Proposal Submissions from Liberal Arts Faculty

    Science.gov (United States)

    Hartmann, Anita

    2011-01-01

    In the current economic climate, many colleges and universities face similar challenges: the need to increase external sponsorship for research activities and the need to benefit from additional indirect cost recovery. Preparing funding proposals for submission to sponsors is a faculty behavior that can be modified by applying behavioral theory to…

  17. Protocol Development and Preliminary Toxicity Study of CBRN Nanomaterials

    Science.gov (United States)

    2013-12-05

    developmental problems in offspring. One study found titanium dioxide ( TiO2 ) nanoparticles were present in the placenta, fetal liver and fetal brain. This...lungs, but can also cross into the blood stream and disseminate deeper inside the body to threaten the brain, liver, kidney , and other tissues/organs...is quite different than for micro-sized TiO2 particles, which are considered inert and relatively non-toxic to experimental animals and humans

  18. Study of Repair Protocols for Live Video Streaming Distributed Systems

    OpenAIRE

    Giroire, Frédéric; Huin, Nicolas

    2015-01-01

    International audience; —We study distributed systems for live video streaming. These systems can be of two types: structured and un-structured. In an unstructured system, the diffusion is done opportunistically. The advantage is that it handles churn, that is the arrival and departure of users, which is very high in live streaming systems, in a smooth way. On the opposite, in a structured system, the diffusion of the video is done using explicit diffusion trees. The advantage is that the dif...

  19. Protocol Coordinator III | Center for Cancer Research

    Science.gov (United States)

    Provides programmatic and logistical support for the operations of clinical research Provides deployment of clinical support services for clinical research Streamlines the protocol development timeline Provides data and documents collection and compilation for regulatory filing with the Food and Drug Administration (FDA) and other regulatory authorities Provides technical review and report preparation Provides administrative coordination and general logistical support for regulatory activities Ensures the provision of training for investigators and associate staff to reinforce and enhance a Good Clinical Practices (GCP) culture Oversees quality assurance and quality control, performs regulatory review of clinical protocols, informed consent and other clinical documents Tracks and facilitates a portfolio of protocols through each process step (Institutional Review Board [IRB], Regulatory Affairs Compliance [RAC], Data Safety Monitoring Board [DSMB], Office of Protocol Services) Assists clinical investigators in preparing clinical research protocols, including writing and formatting consent forms Prepares protocol packages for review and ensures that protocol packages include all required material and complies with CCR, NCI and NIH policies Collaborates with investigators to resolve any protocol/data issues Coordinates submission of protocols for scientific and ethical review by the Branch scientific review committees, the NCI IRB, and the clinical trial sponsor or the FDA Monitors the review process and maintains detailed, complete and accurate approval records for each protocol at the various stages of the review process, including new protocol submissions, amendments to protocols, and continuing reviews, as well as other submissions such as adverse events Attends and prepares minutes for the Branch Protocol Review Committees Contacts coordinators at other centers for protocols that are performed there to obtain review committee approvals at those centers

  20. Understanding context in knowledge translation: a concept analysis study protocol.

    Science.gov (United States)

    Squires, Janet E; Graham, Ian D; Hutchinson, Alison M; Linklater, Stefanie; Brehaut, Jamie C; Curran, Janet; Ivers, Noah; Lavis, John N; Michie, Susan; Sales, Anne E; Fiander, Michelle; Fenton, Shannon; Noseworthy, Thomas; Vine, Jocelyn; Grimshaw, Jeremy M

    2015-05-01

    To conduct a concept analysis of clinical practice contexts (work environments) that facilitate or militate against the uptake of research evidence by healthcare professionals in clinical practice. This will involve developing a clear definition of context by describing its features, domains and defining characteristics. The context where clinical care is delivered influences that care. While research shows that context is important to knowledge translation (implementation), we lack conceptual clarity on what is context, which contextual factors probably modify the effect of knowledge translation interventions (and hence should be considered when designing interventions) and which contextual factors themselves could be targeted as part of a knowledge translation intervention (context modification). Concept analysis. The Walker and Avant concept analysis method, comprised of eight systematic steps, will be used: (1) concept selection; (2) determination of aims; (3) identification of uses of context; (4) determination of defining attributes of context; (5) identification/construction of a model case of context; (6) identification/construction of additional cases of context; (7) identification/construction of antecedents and consequences of context; and (8) definition of empirical referents of context. This study is funded by the Canadian Institutes of Health Research (January 2014). This study will result in a much needed framework of context for knowledge translation, which identifies specific elements that, if assessed and used to tailor knowledge translation activities, will result in increased research use by nurses and other healthcare professionals in clinical practice, ultimately leading to better patient care. © 2014 John Wiley & Sons Ltd.

  1. Study protocol: a systematic review of pediatric shared decision making.

    Science.gov (United States)

    Wyatt, Kirk D; Prutsky Lopez, Gabriela; Domecq Garces, Juan Pablo; Erwin, Patricia; Brinkman, William B; Montori, Victor M; LeBlanc, Annie

    2013-07-01

    Shared decision making in pediatrics is unique because it often involves active participation of both the child or adolescent patient and his or her caregiver(s) in the decision making process with the clinician or care team, and the extent to which the patient is involved is commensurate with their developmental level. However, little is known about the nature of pediatric-specific shared decision making interventions and their impact. We will perform a systematic review with the objective of summarizing the nature of shared decision making practices, tools, techniques and technologies in the pediatric setting as well as their effects. A literature search will include Ovid MEDLINE, Ovid EMBASE, Ovid Cochrane Library, Web of Science, Scopus and Ovid PsycInfo databases in addition to consultation of a group of shared decision making experts to identify unpublished or in-progress works. We will include original research studies involving patients methods and approaches designed to engage participants in the health care decision making process with clinicians. Perinatal and research participation decisions will be excluded. Descriptions of participants involved, interventions used and the measured outcomes will be reported. Quality assessment will be performed according to the design of each study, where possible. We anticipate that the paucity of published quantitative data and the heterogeneous nature of the reported results will preclude quantitative analysis. In this event, a meta-narrative approach will be undertaken. PROSPERO registration number: CRD42013004761.

  2. Structured Wii protocol for rehabilitation of shoulder impingement syndrome: A pilot study.

    Science.gov (United States)

    Rizzo, John-Ross; Thai, Peter; Li, Edward J; Tung, Terence; Hudson, Todd E; Herrera, Joseph; Raghavan, Preeti

    2017-03-15

    To determine the feasibility and efficacy of using a structured Nintendo Wii protocol to improve range of motion, strength, and quality of life in patients with shoulder impingement syndrome. A total of 14 patients with shoulder pain were randomized to perform a structured Wii protocol (n=8) or conventional therapy (n=6). Pain-free shoulder range of motion, strength, shoulder pain and disability, and quality of life were assessed pre- and post-treatment. All 8 patients completed the Wii protocol, and 3 completed conventional therapy. The Wii protocol conferred significant improvements in shoulder range of motion, pain and disability, and quality of life but not strength, whereas conventional therapy conferred a significant improvement in strength. As compared to conventional treatment, the structured Wii protocol implemented in this pilot study was a viable adjunct to therapy for shoulder impingement syndrome. Gaming may have a supplemental benefit by increasing motivation, pleasure, and/or adherence. Further investigation in larger cohorts is warranted. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

  3. Comparative study of preventive protocols in children at high cariogenic risk.

    Science.gov (United States)

    Martínez, María C; Tolcachir, Betina; Lescano de Ferrer, Alfonsina; Bojanich, María A; Barembaum, Silvina R; Calamari, Silvia E; Azcurra, Ana I

    2012-01-01

    The aim of this study was to compare the efficacy of two preventive protocols -fluoride gel (F) alone or combined with chlorhexidine varnishes (CHX) - on sialochemical, clinical and microbiological parameters in a group of children at high cariogenic risk Two therapeutic-preventive protocols were applied in 73 children at high cariogenic risk (average age 6.2 +/- 1.4 years old) and clinical parameters (simplified oral hygiene index: OHI-S; decayed, missing and filled teeth: dmf index; sugar intake and exposure to fluoride), as well as sialochemical parameters (salivary pH and flow, buffer capacity) and microbiological parameters (CFU/mg of dental biofilm of Streptococcus mutans group) were recorded and correlated before and after the protocols. Association was found between parameters that cause deficient control of dental biofilm: high values of OHIS index, CFU/mg dental biofilm, sugar intake and the d component of dmft index, and lower values of salivary flow rate and buffer capacity. After the protocols, a significant decrease was found in OHI-S and CFU/mg dental biofilm. No significant difference was found with children's gender and age. The association observed between OHI-S and cariogenic bacteria emphasizes the importance of prevention, especially regarding the oral health of the most vulnerable children. The early inclusion of F associated with CHX in the initial step of preventive and therapeutic protocols would provide benefits regarding oral microbe control while children acquire new habits of oral hygiene.

  4. Iran's Multiple Indicator Demographic and Health Survey - 2010: Study Protocol.

    Science.gov (United States)

    Rashidian, Arash; Karimi-Shahanjarini, Akram; Khosravi, Ardeshir; Elahi, Elham; Beheshtian, Maryam; Shakibazadeh, Elham; Khabiri, Roghayeh; Arab, Mohammad; Zakeri, Mohammad-Reza

    2014-05-01

    There is an international emphasis on providing timely and high quality data to monitor progress of countries toward Millennium Development Goals. Iran's Multiple Indicator Demographic and Health Survey (IrMIDHS) aimed to provide valid information on population and health outcomes to monitor progress in achieving national priorities and health programs and to assist policy makers to design effective strategies for improving health outcomes and equity in access to care. A cross-sectional multi-stage stratified cluster-random survey is conducted through face-to-face household interviews. The sampling frame is developed using Iran's 2006 population and housing census. Provincial samples ranging are from a minimum of 400 households per province to 6400 households in Tehran province. Cluster size is 10 households. The target sample includes 3096 clusters: 2187 clusters in urban and 909 clusters in rural areas. IrMIDHS instruments include three questionnaires: Household questionnaire, women aged 15-54 questionnaire, children under five questionnaire, supervision and quality assessment checklists and data collection sheets and standard weight and height measurement tools for under-five children. A cascading decentralized training method is used for training data collection and supervision teams. Quality assurance procedures are defined for the five steps of conducting the survey including: Sampling, training data collection and training teams, survey implementation, data entry and analysis. A multi-layer supervision and monitoring procedure is established. All the questionnaires are double entered. IrMIDHS will provide valuable data for policymakers in Iran. Designing and implementation of the study involve contributions from academics as well as program managers and policy makers. The collaborative nature of the study may facilitate better usage of its results.

  5. Advantages of a Warfarin Protocol for Long-term Care Pharmacists: a Retrospective Cohort Study.

    Science.gov (United States)

    Sargent, Randall; Brocklebank, Cynthia; Tam-Tham, Helen; Williamson, Tyler; Quail, Patrick; Turner, Diana; Drummond, Neil

    2016-06-01

    Warfarin is an anticoagulant prescribed to 12% of long-term care residents to reduce the risk of thrombo-embolism. This study used indicators to compare warfarin management by pharmacists to usual care. This was a retrospective cohort study comparing a pharmacist-managed warfarin protocol with usual care of qualified warfarin recipients at long-term care facilities (two protocol, one control) in Calgary, Alberta. We compared the proportion of international normalized ratio (INR) tests in the range 2.0 to 3.0, time in range, number of tests, and frequency of bleeding at protocol and control sites. Our primary outcome, time in INR therapeutic range, is an indicator for assuring care quality. A cross-sectional survey at these sites compared health professionals' perceptions of workload and effectiveness of warfarin management. Of the 197 residents' charts reviewed in the study period, those on protocol had 45.0 INR tests while those on usual care had 52.7 tests (p = .034, 95% CI for the difference: 0.6 to 14.6 INR tests). No significant difference was found for time in therapeutic range, number of tests in range, or major bleeding events. Of 178 health professionals surveyed, those from protocol facilities were more satisfied with warfarin management (p = .013). Workload and safety were perceived similarly at all sites. Our results suggest that a pharmacist-managed warfarin protocol is as effective as usual care and has advantages pertaining to work satisfaction, knowledge of drug interactions, consistent documentation, and fewer INR tests. Further research on teamwork and coagulation management in long-term care facilities is recommended.

  6. FIRE (facilitating implementation of research evidence: a study protocol

    Directory of Open Access Journals (Sweden)

    Seers Kate

    2012-03-01

    Full Text Available Abstract Background Research evidence underpins best practice, but is not always used in healthcare. The Promoting Action on Research Implementation in Health Services (PARIHS framework suggests that the nature of evidence, the context in which it is used, and whether those trying to use evidence are helped (or facilitated affect the use of evidence. Urinary incontinence has a major effect on quality of life of older people, has a high prevalence, and is a key priority within European health and social care policy. Improving continence care has the potential to improve the quality of life for older people and reduce the costs associated with providing incontinence aids. Objectives This study aims to advance understanding about the contribution facilitation can make to implementing research findings into practice via: extending current knowledge of facilitation as a process for translating research evidence into practice; evaluating the feasibility, effectiveness, and cost-effectiveness of two different models of facilitation in promoting the uptake of research evidence on continence management; assessing the impact of contextual factors on the processes and outcomes of implementation; and implementing a pro-active knowledge transfer and dissemination strategy to diffuse study findings to a wide policy and practice community. Setting and sample Four European countries, each with six long-term nursing care sites (total 24 sites for people aged 60 years and over with documented urinary incontinence Methods and design Pragmatic randomised controlled trial with three arms (standard dissemination and two different programmes of facilitation, with embedded process and economic evaluation. The primary outcome is compliance with the continence recommendations. Secondary outcomes include proportion of residents with incontinence, incidence of incontinence-related dermatitis, urinary tract infections, and quality of life. Outcomes are assessed at baseline

  7. Study protocol for the Fukushima Health Management Survey.

    Science.gov (United States)

    Yasumura, Seiji; Hosoya, Mitsuaki; Yamashita, Shunichi; Kamiya, Kenji; Abe, Masafumi; Akashi, Makoto; Kodama, Kazunori; Ozasa, Kotaro

    2012-01-01

    The accidents that occurred at the Fukushima Daiichi Nuclear Power Plant after the Great East Japan Earthquake on 11 March 2011 have resulted in long-term, ongoing anxiety among the residents of Fukushima, Japan. Soon after the disaster, Fukushima Prefecture launched the Fukushima Health Management Survey to investigate long-term low-dose radiation exposure caused by the accident. Fukushima Medical University took the lead in planning and implementing this survey. The primary purposes of this survey are to monitor the long-term health of residents, promote their future well-being, and confirm whether long-term low-dose radiation exposure has health effects. This report describes the rationale and implementation of the Fukushima Health Management Survey. This cohort study enrolled all people living in Fukushima Prefecture after the earthquake and comprises a basic survey and 4 detailed surveys. The basic survey is to estimate levels of external radiation exposure among all 2.05 million residents. It should be noted that internal radiation levels were estimated by Fukushima Prefecture using whole-body counters. The detailed surveys comprise a thyroid ultrasound examination for all Fukushima children aged 18 years or younger, a comprehensive health check for all residents from the evacuation zones, an assessment of mental health and lifestyles of all residents from the evacuation zones, and recording of all pregnancies and births among all women in the prefecture who were pregnant on 11 March. All data have been entered into a database and will be used to support the residents and analyze the health effects of radiation. The low response rate (<30%) to the basic survey complicates the estimation of health effects. There have been no cases of malignancy to date among 38 114 children who received thyroid ultrasound examinations. The importance of mental health care was revealed by the mental health and lifestyle survey and the pregnancy and birth survey. This long

  8. Impact of study outcome on submission and acceptance metrics for peer reviewed medical journals: six year retrospective review of all completed GlaxoSmithKline human drug research studies.

    Science.gov (United States)

    Evoniuk, Gary; Mansi, Bernadette; DeCastro, Barbara; Sykes, Jennie

    2017-04-21

    Objectives To determine whether the outcome of drug studies influenced submission and/or acceptance rates for publication in peer reviewed medical journals.Design A six year retrospective review of publication status by study outcome for all human drug research studies conducted by a single industry sponsor (GlaxoSmithKline) that completed from 1 January 2009 to 30 June 2014 and were therefore due for manuscript submission (per the sponsor's policy) to peer reviewed journals within 18 months of study completion-that is, 31 December 2015. In addition, manuscripts from studies completing after 30 June 2014 were included irrespective of outcome if they were submitted before 31 December 2015.Setting Studies conducted by a single industry sponsor (GlaxoSmithKline)Studies reviewed 1064 human drug research studies.Main outcome measures All studies were assigned a publication status at 26 February 2016 including (as applicable): study completion date, date of first primary manuscript submission, number of submissions, journal decision(s), and publication date. All studies were also classified with assessors blinded to publication status as "positive" (perceived favorable outcome for the drug under study), "negative" (perceived unfavorable outcome for the drug under study), mixed, or non-comparative based on the presence and outcome of the primary outcome measure(s) for each study. "Negative" studies included safety studies in which the primary outcome was achieved but was adverse for the drug under study. For the total cohort and each of the four study outcomes, measures included descriptive statistics for study phase, time from study completion to submission and publication, and number and outcome (accepted/rejected) of publication submissions.Results Of the 1064 studies (phase I-IV, interventional and non-interventional) included, 321 had study outcomes classified as positive, 155 as negative, 52 as mixed, and 536 as non-comparative. At the time of publication cut

  9. Emotion processing and social participation following stroke: study protocol

    Directory of Open Access Journals (Sweden)

    Scott Clare L

    2012-07-01

    Full Text Available Abstract Background The International Classification of Functioning, Disability and Health (ICF defines participation as a person’s performance in life situations, including the size of social networks, and satisfaction with social contacts. Stroke survivors are known to experience a reduction in the number of their social networks and contacts, which cannot be explained solely in terms of activity limitations caused by physical impairment. Problems of emotional processing, including impaired mood, emotion regulation and emotion perception, are known to occur following stroke and can detrimentally influence many aspects of social interaction and participation. The aim of this study is to investigate whether emotion processing impairments predict stroke survivors’ restricted social participation, independent of problems with activity limitation. Methods/design We aim to recruit 125 patients admitted to NHS Grampian with a confirmed diagnosis of stroke. All participants will be assessed on measures of emotion processing, social participation and activity limitation at approximately one month post stroke and again at approximately one year post stroke in order to assess change over time. Discussion It is important to develop a greater understanding of the emotional factors which may underlie key social deficits in stroke recovery in an ageing population where stroke is one of the leading causes of severe, complex disability. This research may enable us to identify those who are risk of participation restriction and target them in the acute stroke phase of stroke so that adverse outcome is avoided and rehabilitation potential is fulfilled.

  10. Journey to vaccination: a protocol for a multinational qualitative study.

    Science.gov (United States)

    Wheelock, Ana; Miraldo, Marisa; Parand, Anam; Vincent, Charles; Sevdalis, Nick

    2014-01-31

    In the past two decades, childhood vaccination coverage has increased dramatically, averting an estimated 2-3 million deaths per year. Adult vaccination coverage, however, remains inconsistently recorded and substandard. Although structural barriers are known to limit coverage, social and psychological factors can also affect vaccine uptake. Previous qualitative studies have explored beliefs, attitudes and preferences associated with seasonal influenza (flu) vaccination uptake, yet little research has investigated how participants' context and experiences influence their vaccination decision-making process over time. This paper aims to provide a detailed account of a mixed methods approach designed to understand the wider constellation of social and psychological factors likely to influence adult vaccination decisions, as well as the context in which these decisions take place, in the USA, the UK, France, India, China and Brazil. We employ a combination of qualitative interviewing approaches to reach a comprehensive understanding of the factors influencing vaccination decisions, specifically seasonal flu and tetanus. To elicit these factors, we developed the journey to vaccination, a new qualitative approach anchored on the heuristics and biases tradition and the customer journey mapping approach. A purposive sampling strategy is used to select participants who represent a range of key sociodemographic characteristics. Thematic analysis will be used to analyse the data. Typical journeys to vaccination will be proposed. Vaccination uptake is significantly influenced by social and psychological factors, some of which are under-reported and poorly understood. This research will provide a deeper understanding of the barriers and drivers to adult vaccination. Our findings will be published in relevant peer-reviewed journals and presented at academic conferences. They will also be presented as practical recommendations at policy and industry meetings and healthcare

  11. The Bipolar Interactive Psychoeducation (BIPED study: trial design and protocol

    Directory of Open Access Journals (Sweden)

    Jones Ian

    2009-08-01

    Full Text Available Abstract Background Bipolar disorders affect between 3–5% of the population and are associated with considerable lifelong impairment. Since much of the morbidity associated with bipolar disorder is caused by recurrent depressive symptoms, which are often only poorly responsive to antidepressants, there is a need to develop alternative, non-pharmacological interventions. Psychoeducational interventions have emerged as promising long-term therapeutic options for bipolar disorder. Methods/design The study is an exploratory, individually randomised controlled trial. The intervention known as 'Beating Bipolar' is a psychoeducational programme which is delivered via a novel web-based system. We will recruit 100 patients with a diagnosis of DSM-IV bipolar disorder (including type I and type II currently in clinical remission. The primary outcome is quality of life. This will be compared for those patients who have participated in the psychoeducational programme with those who received treatment as usual. Quality of life will be assessed immediately following the intervention as well as 10 months after randomisation. Secondary outcomes include current depressive and manic symptoms, number of episodes of depression and mania/hypomania experienced during the follow-up period, global functioning, functional impairment and insight. An assessment of costs and a process evaluation will also be conducted which will explore the feasibility and acceptability of the intervention as well as potential barriers to effectiveness. Discussion Bipolar disorder is common, under-recognised and often poorly managed. It is a chronic, life-long, relapsing condition which has an enormous impact on the individual and the economy. This trial will be the first to explore the effectiveness of a novel web-based psychoeducational intervention for patients with bipolar disorder which has potential to be easily rolled out to patients. Trial registration Current Controlled Trials

  12. Declarative Specification of Fault Tolerant Auction Protocols: The English Auction Case Study

    DEFF Research Database (Denmark)

    Dragoni, Nicola; Gaspari, Mauro

    2012-01-01

    an auction process even if some bidding agents dynamically crash. In this paper, we propose an approach to specify fault tolerant auction protocols in open and dynamic environments by means of communication rules dealing with crash failures of agents. We illustrate these concepts considering a case study......Auction mechanisms are nowadays widely used in electronic commerce Web sites for buying and selling items among different users. The increasing importance of auction protocols in the negotiation phase is not limited to online marketplaces. In fact, the wide applicability of auctions as resource...... and shared allowing agents to dynamically engage well‐known and trusted negotiation protocols. To cope with real‐world applications, these rules should also specify fault tolerant patterns of interaction, enabling negotiating agents to interact with each other tolerating failures, for instance terminating...

  13. Protocol adherence for continuously titrated interventions in randomized trials: an overview of the current methodology and case study

    Directory of Open Access Journals (Sweden)

    F. Lauzier

    2017-07-01

    Full Text Available Abstract Background The standard definition for protocol adherence is the proportion of all scheduled doses that are delivered. In clinical research, this definition has several limitations when evaluating protocol adherence in trials that study interventions requiring continuous titration. Discussion Building upon a specific case study, we analyzed a recent trial of a continuously titrated intervention to assess the impact of different definitions of protocol deviations on the interpretation of protocol adherence. The OVATION pilot trial was an open-label randomized controlled trial of higher (75–80 mmHg versus lower (60–65 mmHg mean arterial pressure (MAP targets for vasopressor therapy in shock. In this trial, potential protocol deviations were defined as MAP values outside the targeted range for >4 consecutive hours during vasopressor therapy without synchronous and consistent adjustments of vasopressor doses. An adjudication committee reviewed each potential deviation to determine if it was clinically-justified or not. There are four reasons for this contextual measurement and reporting of protocol adherence. First, between-arm separation is a robust measure of adherence to complex protocols. Second, adherence assessed by protocol deviations varies in function of the definition of deviations and the frequency of measurements. Third, distinguishing clinically-justified vs. not clinically-justified protocol deviations acknowledges clinically sensible bedside decision-making and offers a clear terminology before the trial begins. Finally, multiple metrics exist to report protocol deviations, which provides different information but complementary information on protocol adherence. Conclusions In trials of interventions requiring continuous titration, metrics used for defining protocol deviations have a considerable impact on the interpretation of protocol adherence. Definitions for protocol deviations should be prespecified and correlated

  14. Digital protocol for reference-based guided surgery and immediate loading: a prospective clinical study

    NARCIS (Netherlands)

    Tahmaseb, A.; de Clerck, R.; Aartman, I.; Wismeijer, D.

    2012-01-01

    PURPOSE: To evaluate the performance of a computer-aided three-dimensional planning protocol in combination with previously inserted reference mini-implants and CAD/CAM technology to restore completely edentulous patients. The study evaluated implant and superstructure survival in a prospective

  15. Study protocol

    DEFF Research Database (Denmark)

    Smith, Benjamin E; Hendrick, Paul; Bateman, Marcus

    2017-01-01

    and acceptability of conducting a definitive RCT which will evaluate the clinical and cost-effectiveness of a loaded self-managed exercise programme for people with patellofemoral pain. METHOD: This is a single-centred, multiphase, sequential, mixed-methods trial that will evaluate the feasibility of running...... that target movements and activities patients find fearful and painful. High-quality research on exercise prescription in relation to pain mechanisms, not directed at specific tissue pathology, and dose response clearly warrants further investigation. Our primary aim is to establish the feasibility...... a definitive large-scale randomised controlled trial of a loaded self-managed exercise programme versus usual physiotherapy. Initially, 8-10 participants with a minimum 3-month history of PFP will be recruited from an NHS physiotherapy waiting list and interviewed. Participants will be invited to discuss...

  16. Variation in institutional review board responses to a standard, observational, pediatric research protocol.

    Science.gov (United States)

    Mansbach, Jonathan; Acholonu, Uchechi; Clark, Sunday; Camargo, Carlos A

    2007-04-01

    Multicenter studies are becoming more common, and variability in local institutional review board (IRB) assessments can be problematic. To investigate the variability of IRB responses to a multicenter observational study of children presenting to emergency departments. The authors collected the original IRB applications, subsequent correspondence, and a survey assessing submission timing and response and the nature of IRB queries. The study was conducted as part of the Emergency Medicine Network (http://www.emnet-usa.org). Of 37 sites initiating the IRB process, 34 (92%) participated in this IRB-approved study. Institutional review boards returned initial applications in a median of 19 days (IQR, 11-34 d), and 91% considered the protocol to be minimal risk. Of 34 submissions, 13 required no changes, 18 received conditional approvals, and 3 were deferred. The median time from initial submission to final approval was 42 days (IQR, 27-61 d). Seven sites did not participate in patient recruitment: two had institutional issues, one obtained IRB approval too late for participation, and four sites (12%) reported that IRB hurdles contributed to their lack of participation. Nonetheless, 68% of sites that recruited patients reported that the overall experience made them more likely to participate in future multicenter research. There was substantial variation in IRB assessment of a standard protocol in this study. The burden of the application process contributed to some investigators not participating, but the majority of investigators remain enthusiastic about multicenter research. A national IRB may streamline the review process and facilitate multicenter clinical research.

  17. Bioindicators in the MIDUS National Study: Protocol, Measures, Sample, and Comparative Context

    Science.gov (United States)

    Love, Gayle Dienberg; Seeman, Teresa E.; Weinstein, Maxine; Ryff, Carol D.

    2010-01-01

    Objectives MIDUS is a national study of health and aging among individuals aged 25 to 74 at baseline(1995/96). Longitudinal survey assessments (2004/05), were followed by biological assessments on a subsample aged 35–85. To facilitate public use, we describe the protocol, measures, and sample. Methods Respondents traveled to clinics for a two-day data collection protocol that included fasting blood specimens, 12-hour urine specimen, medical history, physical exam, bone densitometry, a laboratory challenge (heart rate variability, blood pressure, respiration, salivary cortisol). Results Response rates for the biological protocol (N = 1,255) were 39.3%, or 43.1% (adjusting for those who could not be located or contacted). Reasons for non-participation were travel, family obligations, and being too busy. Respondents were comparable to the recruitment pool on most demographic characteristics and health assessments. Discussion Strengths of the protocol vis-à-vis other similar studies include opportunities to link biological factors with diverse content from other MIDUS projects. PMID:20876364

  18. Developing an acupuncture protocol for treating phantom limb pain: a Delphi consensus study.

    Science.gov (United States)

    Trevelyan, Esmé G; Turner, Warren A; Robinson, Nicola

    2015-02-01

    Little is known about how a Traditional Chinese Medicine (TCM) approach could be used to treat phantom limb pain (PLP). There is currently no standard acupuncture protocol in the literature to treat this syndrome. To achieve consensus among a group of acupuncture practitioners on the pathology and recommended treatment of PLP and devise an acupuncture protocol for the treatment of this condition. A classical Delphi approach was used using two parallel online Delphi studies. One study focused on participants with past experience of treating PLP (TPLP, n=7) and the other on practitioners with no past experience (NTPLP, n=16). Two hypothetical case studies were provided and participants were asked for responses on how they would treat these patients. Three rounds were included. Participants were also invited to rate and comment on the finalised protocol. Round 1 data were analysed using content analysis. In subsequent rounds an a priori criterion for defining consensus was set at ≤1.75 IQR. A group median of 5-6 was considered to mean 'agree'. 19 participants completed all Delphi rounds (12 NTPLP, 7 TPLP). 108 NTPLP and 76 TPLP statements were generated and circulated in round 2; 53% of the NTPLP statements and 62% of the TPLP statements met consensus in round 2 and 45% of the NTPLP statements and 44% of the TPLP statements met consensus in round 3. Participants all agreed with the final protocol developed. The protocol developed does not claim to be best practice but provides a preliminary consensus from practitioners practising acupuncture for the treatment of PLP. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  19. Implementation of Symptom Protocols for Nurses Providing Telephone‐Based Cancer Symptom Management: A Comparative Case Study

    Science.gov (United States)

    Green, Esther; Ballantyne, Barbara; Tarasuk, Joy; Skrutkowski, Myriam; Carley, Meg; Chapman, Kim; Kuziemsky, Craig; Kolari, Erin; Sabo, Brenda; Saucier, Andréanne; Shaw, Tara; Tardif, Lucie; Truant, Tracy; Cummings, Greta G.; Howell, Doris

    2016-01-01

    ABSTRACT Background The pan‐Canadian Oncology Symptom Triage and Remote Support (COSTaRS) team developed 13 evidence‐informed protocols for symptom management. Aim To build an effective and sustainable approach for implementing the COSTaRS protocols for nurses providing telephone‐based symptom support to cancer patients. Methods A comparative case study was guided by the Knowledge to Action Framework. Three cases were created for three Canadian oncology programs that have nurses providing telephone support. Teams of researchers and knowledge users: (a) assessed barriers and facilitators influencing protocol use, (b) adapted protocols for local use, (c) intervened to address barriers, (d) monitored use, and (e) assessed barriers and facilitators influencing sustained use. Analysis was within and across cases. Results At baseline, >85% nurses rated protocols positively but barriers were identified (64‐80% needed training). Patients and families identified similar barriers and thought protocols would enhance consistency among nurses teaching self‐management. Twenty‐two COSTaRS workshops reached 85% to 97% of targeted nurses (N = 119). Nurses felt more confident with symptom management and using the COSTaRS protocols (p nursing requires a tailored approach. A multifaceted intervention approach increased nurses’ use of evidence‐informed protocols during telephone calls with patients about symptoms. Training and other interventions improved nurses’ confidence with using COSTaRS protocols and their uptake was evident in some documented telephone calls. Protocols could be adapted for use by patients and nurses globally. PMID:27243574

  20. Study protocol: Mother and Infant Nutritional Assessment (MINA) cohort study in Qatar and Lebanon

    National Research Council Canada - National Science Library

    Naja, Farah; Nasreddine, Lara; Al Thani, Al Anoud; Yunis, Khaled; Clinton, Michael; Nassar, Anwar; Farhat Jarrar, Sara; Moghames, Patricia; Ghazeeri, Ghina; Rahman, Sajjad; Al-Chetachi, Walaa; Sadoun, Eman; Lubbad, Nibal; Bashwar, Zelaikha; Bawadi, Hiba; Hwalla, Nahla

    2016-01-01

    .... The main objective of this manuscript is to describe the protocol of the first cohort in the region to investigate the association of nutrition imbalances early in life with birth outcomes, growth...

  1. Stream Control Transmission Protocol as a Transport for SIP: a case study

    Directory of Open Access Journals (Sweden)

    Giuseppe De Marco

    2004-06-01

    Full Text Available The dominant signalling protocol both in future wireless and wired networks will be the Session Initiation Protocol (SIP, as pointed out in the 3G IP-based mobile networks specifications, entailing a fully Internet integrated network. The use of SIP in the IP Multimedia Subsytem (IMS of Release 5 involves the development of servers capable to handle a large number of call requests. The signaling traffic associated to such requests could explode, if an intelligent congestion control were not introduced. Stream Control Transmission Protocol (SCTP was born to support transport of SS7 signaling messages. However, many of the SCTP features are also useful for transport of SIP messages, as: congestion control mechanism, good separation among independent messages, multihoming. Indeed, adoption of SCTP as transport of SIP signaling might prove useful in some situations where usual transport protocols, like TCP and UDP, suffer performance degradation. In this paper, we analyse the general framework wherein SIP operates and we discuss the benefits of using SCTP as a transport for SIP, toward fair sharing of network resources. This study is carried on in the context of the implementation of an high-performance SIP Proxy Server. We also present some preliminar results of an implementation of SIP over SCTP/UDP in a real LAN environment.

  2. MANUSCRIPT SUBMISSION FORM Upon submission of a ...

    Indian Academy of Sciences (India)

    IAS Admin

    The submission of a paper by a set of authors represents the results of their original research not previously published; that it is not under consideration for publication elsewhere; and that if accepted for the journal, it will not be published elsewhere. ii). The list of authors includes those and all those who have contributed in.

  3. Study protocol: Mother and Infant Nutritional Assessment (MINA) cohort study in Qatar and Lebanon.

    Science.gov (United States)

    Naja, Farah; Nasreddine, Lara; Al Thani, Al Anoud; Yunis, Khaled; Clinton, Michael; Nassar, Anwar; Farhat Jarrar, Sara; Moghames, Patricia; Ghazeeri, Ghina; Rahman, Sajjad; Al-Chetachi, Walaa; Sadoun, Eman; Lubbad, Nibal; Bashwar, Zelaikha; Bawadi, Hiba; Hwalla, Nahla

    2016-05-04

    The Middle East and North Africa region harbors significant proportions of stunting and wasting coupled with surging rates of non-communicable diseases (NCDs). Recent evidence identified nutrition during the first 1000 days of life as a common denominator not only for optimal growth but also for curbing the risk of NCDs later in life. The main objective of this manuscript is to describe the protocol of the first cohort in the region to investigate the association of nutrition imbalances early in life with birth outcomes, growth patterns, as well as early determinants of non-communicable diseases. More specifically the cohort aims to 1) examine the effects of maternal and early child nutrition and lifestyle characteristics on birth outcomes and growth patterns and 2) develop evidence-based nutrition and lifestyle guidelines for pregnant women and young children. A multidisciplinary team of researchers was established from governmental and private academic and health sectors in Lebanon and Qatar to launch the Mother and Infant Nutritional Assessment 3-year cohort study. Pregnant women (n = 250 from Beirut, n = 250 from Doha) in their first trimester are recruited from healthcare centers in Beirut, Lebanon and Doha, Qatar. Participants are interviewed three times during pregnancy (once every trimester) and seven times at and after delivery (when the child is 4, 6, 9, 12, 18, and 24 months old). Delivery and birth data is obtained from hospital records. Data collection includes maternal socio-demographic and lifestyle characteristics, dietary intake, anthropometric measurements, and household food security data. For biochemical assessment of various indicators of nutritional status, a blood sample is obtained from women during their first trimester. Breastfeeding and complementary feeding practices, dietary intake, as well as anthropometric measurements of children are also examined. The Delphi technique will be used for the development of the nutrition and lifestyle

  4. A Pilot Study on the effects of Music Therapy on Frontotemporal Dementia - developing a research protocol

    DEFF Research Database (Denmark)

    Ridder, Hanne Mette Ochsner; Wigram, Tony; Ottesen, Anne Marie

    2009-01-01

    Background: Some forms of dementia particularly affect the frontal parts of the brain which, in some cases, causes the onset of severe behavioural and psychological symptoms. No specific treatment for the primary diseases that cause these frontotemporal dementia conditions has yet been developed....... As an example of a non-pharmacologic treatment procedure music therapy was investigated. With the focus to develop a research protocol for a future larger population study a pilot study was carried out. In two case studies a combination of data collection methods were examined with the overall goal to document...... of Life (ADRQL), the Cohen-Mansfield Agitation Inventory (CMAI), and the Neuro-Psychiatric Inventory (NPI), and related to case descriptions and video analyses. Results: Recommendations for a mixed method research protocol focused on measuring the effect of music therapy with persons with frontotemporal...

  5. Palliative care for patients with Parkinson's disease: study protocol for a mixed methods study.

    Science.gov (United States)

    Lennaerts, Herma; Groot, Marieke; Steppe, Maxime; van der Steen, Jenny T; Van den Brand, Marieke; van Amelsvoort, Dorian; Vissers, Kris; Munneke, Marten; Bloem, Bastiaan R

    2017-11-25

    Parkinson's disease (PD) is a chronic, progressive neurological disorder with many intractable consequences for patients and their family caregivers. Little is known about the possibilities that palliative care could offer to patients and their proxies. Guidelines strongly recommend palliative care to improve the quality of life and - if needed - the quality of dying. However, providing palliative care to persons with PD involves specific challenges. For example, a timely initiation of palliative interventions is difficult because due to the gradually progressive nature of PD, there is often no clear marker for the transition from curative towards palliative care. Furthermore, there is little evidence to indicate which palliative care interventions are effective. Here, we describe the contours of a study that aims to examine the experiences of patients, (bereaved) family caregivers and professionals, with the aim of improving our knowledge about palliative care needs in PD. We will perform a mixed methods study to evaluate the experiences of patients, (bereaved) family caregivers and palliative care professionals. In this study, we focus on Quality of Life, Quality of Care, perceived symptoms, caregiver burden and collaboration between professionals. In phase 1, we will retrospectively explore the views of bereaved family caregivers and professionals by conducting individual interviews and focus group interviews. In phase 2, 5-15 patients with PD and their family caregiver will be followed prospectively for 8-12 months. Data collection will involve semi-structured interviews and questionnaires at three consecutive contact moments. Qualitative data will be audio recorded, transcribed and analyzed using CAQDAS. If patients pass away during the study period, a bereavement interview will be done with the closest family caregiver. This study will offer a broad perspective on palliative care, and the results can be used to inform a palliative care protocol for patients

  6. Prenatal diagnosis and prevention of toxoplasmosis in pregnant women in Northern Vietnam: study protocol.

    Science.gov (United States)

    Smit, G Suzanne A; Vu, Thi Lam Binh; Do, Trung Dung; Speybroeck, Niko; Devleesschauwer, Brecht; Padalko, Elizaveta; Roets, Ellen; Dorny, Pierre

    2017-05-25

    In Vietnam, no systematic prenatal toxoplasmosis screening is in place, and only few studies have assessed the prevalence and importance of this zoonotic parasite infection. In addition, no studies have been conducted to assess the risk factors associated with toxoplasmosis. This study protocol was developed to determine the seroprevalence of toxoplasmosis in pregnant women in Hanoi and Thai Binh, Northern Vietnam, and to evaluate the association with risk factors and congenital toxoplasmosis. The protocol was developed in a way that it could potentially evolve into a countrywide prenatal diagnosis and prevention program, with the main focus on primary prevention. The collaborating gynaecologists will invite eligible pregnant women attending antenatal care for the first time to participate in the study. At first consult, information about toxoplasmosis and its prevention will be provided. All participants will be asked to fill in a questionnaire, which is designed to analyse socio-demographic and biologically plausible risk factors associated with toxoplasmosis, and blood samples will be collected to determine the seroprevalence of toxoplasmosis in pregnant women. In case there is suspicion of a primary infection during pregnancy, the concerned women will be followed-up by the gynaecologists according to a predefined protocol. Every participant will be informed on her serological status, risk factors and prevention measures and is offered appropriate medical information and medical follow-up if required. The hypothesis is that congenital toxoplasmosis is an important but currently under-diagnosed public health problem in Vietnam. This study can strengthen sustainable control of toxoplasmosis in Vietnam, provide a protocol for prenatal diagnosis, boost overall awareness, improve the knowledge about toxoplasmosis prevention and can be essential for evidence-based health policy.

  7. A feasibility study comparing two chiropractic protocols in the treatment of patellofemoral pain syndrome.

    Science.gov (United States)

    Brantingham, James W; Globe, Gary A; Jensen, Muffit L; Cassa, Tammy K; Globe, Denise R; Price, Jennifer L; Mayer, Stephan N; Lee, Felix T

    2009-09-01

    The purpose of this pilot study was to determine the feasibility of (1) using the existing clinic, clinicians, interns, faculty, and staff from our college in conducting all components of a planned randomized controlled clinical trial; (2) successfully recruiting patients with patellofemoral pain syndrome (PFPS); and (3) consistently, effectively, and safely implementing the study protocols and therapy. Diagnostic, treatment, and blind assessment procedures were carried out while recruitment and administrative techniques for managing long-term storage of data and files were developed. Thirty-one patients were randomized into a local manipulative group (group A) or to a full kinetic chain manipulative therapy group (group B), each combined with exercise and soft tissue treatment. The Anterior Knee Pain Scale, visual analog scale, and Patient Satisfaction Scale were used. All phases of the feasibility study including use of the clinic, staff, recruitment techniques, treatment protocols, data collection, input, and analysis were effectively and safely carried out. A feasibility study investigating the ability to conduct a randomized controlled trial of a manipulative therapy protocol for PFPS using available chiropractic college infrastructure was accomplished. A fully powered PFPS trial is feasible and merited.

  8. A protocol of a cross-sectional study evaluating an online tool for early career peer reviewers assessing reports of randomised controlled trials

    Science.gov (United States)

    Moher, David; Altman, Doug; Schriger, David L; Alam, Sabina; Hopewell, Sally; Shanahan, Daniel R; Recchioni, Alessandro; Ravaud, Philippe; Boutron, Isabelle

    2017-01-01

    Introduction Systematic reviews evaluating the impact of interventions to improve the quality of peer review for biomedical publications highlighted that interventions were limited and have little impact. This study aims to compare the accuracy of early career peer reviewers who use an innovative online tool to the usual peer reviewer process in evaluating the completeness of reporting and switched primary outcomes in completed reports. Methods and analysis This is a cross-sectional study of individual two-arm parallel-group randomised controlled trials (RCTs) published in the BioMed Central series medical journals, BMJ, BMJ Open and Annals of Emergency Medicine and indexed with the publication type ‘Randomised Controlled Trial’. First, we will develop an online tool and training module based (a) on the Consolidated Standards of Reporting Trials (CONSORT) 2010 checklist and the Explanation and Elaboration document that would be dedicated to junior peer reviewers for assessing the completeness of reporting of key items and (b) the Centre for Evidence-Based Medicine Outcome Monitoring Project process used to identify switched outcomes in completed reports of the primary results of RCTs when initially submitted. Then, we will compare the performance of early career peer reviewers who use the online tool to the usual peer review process in identifying inadequate reporting and switched outcomes in completed reports of RCTs at initial journal submission. The primary outcome will be the mean number of items accurately classified per manuscript. The secondary outcomes will be the mean number of items accurately classified per manuscript for the CONSORT items and the sensitivity, specificity and likelihood ratio to detect the item as adequately reported and to identify a switch in outcomes. We aim to include 120 RCTs and 120 early career peer reviewers. Ethics and dissemination The research protocol was approved by the ethics committee of the INSERM Institutional Review

  9. Anemia of chronic kidney disease: Protocol of study, management and referral to Nephrology.

    Science.gov (United States)

    Cases, Aleix; Egocheaga, M Isabel; Tranche, Salvador; Pallarés, Vicente; Ojeda, Raquel; Górriz, José Luis; Portolés, José María

    2017-11-08

    The objective of this protocol is to know which test are needed to study an anaemia in a patient with chronic kidney disease, the differential diagnosis of renal anaemia, to know and correct other deficiency anaemias, and the criteria for referral to Nephrology or other specialties of the anaemic patient with chronic kidney disease. Copyright © 2017 Sociedad Española de Nefrología. Published by Elsevier España, S.L.U. All rights reserved.

  10. Regulatory Submission Coordinator | Center for Cancer Research

    Science.gov (United States)

    The Clinical Monitoring Research Program (CMRP) provides administrative support to the National Cancer Institute’s (NCI’s), Center for Cancer Research (CCR), Protocol Support Office (PSO). KEY ROLES/RESPONSIBILITIES Performs regulatory submission/administrative duties for the Protocol Support Office, NCI/CCR Assists with the preparation of documents to include protocols, investigator brochures, consent forms, and submissions to the FDA Maintains revision logs and tracking versions of the documents Provides accurate filing of pertinent regulatory documents Provides administrative support related to document control requirements including filing of master documents, formatting and typing of various document Attends regulatory and administrative meetings for taking and typing of minutes, reports and summaries Communicates with clinical, administrative and management personnel to gather or convey information Edits and prepares material for final review Participates in planning functions Works in conjunction with other administrative staff to accomplish program requirements Acts as liaison coordinating tasks/deadlines between the Clinical Research ARC and the Branch This position is located in Rockville, Maryland.

  11. Factors influencing ambulance nurses' adherence to a national protocol ambulance care: an implementation study in the Netherlands

    NARCIS (Netherlands)

    Ebben, R.H.; Vloet, L.C.M.; Grunsven, P.M. van; Breeman, W.; Goosselink, B.; Lichtveld, R.A.; Groot, J. de; Achterberg, T. van

    2015-01-01

    OBJECTIVES: Adherence to prehospital guidelines and protocols is suboptimal. Insight into influencing factors is necessary to improve adherence. The aim of this study was to identify factors that influence ambulance nurses' adherence to a National Protocol Ambulance Care (NPAC). METHODS: A

  12. 78 FR 24220 - Submission for OMB Review; 30-Day Comment Request: Women's Health Initiative Observational Study

    Science.gov (United States)

    2013-04-24

    ... historical, physical, psychosocial, and physiologic characteristics. In addition, the observational study... information on the common causes of frailty, disability and death for postmenopausal women, namely, coronary...

  13. The longitudinal urban cohort ageing study (LUCAS: study protocol and participation in the first decade

    Directory of Open Access Journals (Sweden)

    Dapp Ulrike

    2012-07-01

    Full Text Available Abstract Background We present concept, study protocol and selected baseline data of the Longitudinal Urban Cohort Ageing Study (LUCAS in Germany. LUCAS is a long-running cohort study of community-dwelling seniors complemented by specific studies of geriatric patients or diseases. Aims were to (1 Describe individual ageing trajectories in a metropolitan setting, documenting changes in functional status, the onset of frailty, disability and need of care; (2 Find determinants of healthy ageing; (3 Assess long-term effects of specific health promotion interventions; (4 Produce results for health care planning for fit, pre-frail, frail and disabled elderly persons; (5 Set up a framework for embedded studies to investigate various hypotheses in specific subgroups of elderly. Methods/Design In 2000, twenty-one general practitioners (GPs were recruited in the Hamburg metropolitan area; they generated lists of all their patients 60 years and older. Persons not terminally ill, without daily need of assistance or professional care were eligible. Of these, n = 3,326 (48 % agreed to participate and completed a small (baseline and an extensive health questionnaire (wave 1. In 2007/2008, a re-recruitment took place including 2,012 participants: 743 men, 1,269 women (647 deaths, 197 losses, 470 declined further participation. In 2009/2010 n = 1,627 returned the questionnaire (90 deaths, 47 losses, 248 declined further participation resulting in a good participation rate over ten years with limited and quantified dropouts. Presently, follow-up data from 2007/2008 (wave 2 and 2009/2010 (wave 3 are available. Data wave 4 is due in 2011/2012, and the project will be continued until 2013. Information on survival and need of nursing care was collected continuously and cross-checked against official records. We used Fisher’s exact test and t-tests. The study served repeatedly to evaluate health promotion interventions and concepts. Discussion LUCAS

  14. 77 FR 60113 - Acceptance of Public Submissions Regarding the Study of Stable Value Contracts

    Science.gov (United States)

    2012-10-02

    ... (``SVCs'') fall within the definition of a swap. The study is required by Section 719(d) of the Dodd-Frank....regulations.gov ). Follow the instructions for submitting comments. Paper Comments Send paper comments in... Commissions jointly must conduct a study to determine whether SVCs fall within the definition of a swap.\\2...

  15. The efficacy of acupuncture on menopausal symptoms (ACOM study): protocol for a randomised study.

    Science.gov (United States)

    Lund, Kamma Sundgaard; Brodersen, John; Siersma, Volkert; Waldorff, Frans Boch

    2017-03-01

    Around 75% of menopausal women experience hot flushes (HF) and 10-20% of all postmenopausal women find this very distressing. The aim of this study is to evaluate the efficacy of acupuncture on moderate-to-severe menopausal symptoms in general and HF in particular. An un-blinded randomised trial (cross-over) with 1:1 allocation to early (intervention) versus late (control) acupuncture. The included women suffer from moderate-to-severe HF and will receive a weekly treatment during five consecutive weeks in the following predefined acupuncture points: CV-3, CV-4, LR-8, SP-6, SP-9. All acupuncturists will be medical doctors educated in acupuncture. The primary outcome is change in HF from baseline to week 6 measured by the HF scale from the MenoScores Questionnaire (MSQ). Secondary outcomes are change in other menopausal symptoms, in particular day and night sweats and menopausal-specific sleeping problems, also measured by other scales from the MSQ. A total of 68 patients must be enrolled to detect a relevant clinical reduction on the above MSQ scales. Both intention-to-treat and per-protocol analyses will be conducted; four or more treatments are considered adequate adherence. In the ACOM study, we explore the potential benefits of acupuncture on moderate-to-severe meno-pausal symptoms. The cross-over design offers the possi-bility of examining the legacy effect of acupuncture. The Idella Foundation, the University of Copenhagen and the Research Foundation of General Practice. Clinicaltrials NCT02746497.

  16. A Protocol to Collect Specific Mouse Skeletal Muscles for Metabolomics Studies.

    Science.gov (United States)

    Gan, Zhuohui; Fu, Zhenxing; Stowe, Jennifer C; Powell, Frank L; McCulloch, Andrew D

    2016-01-01

    Due to the highly sensitive nature of metabolic states, the quality of metabolomics data depends on the suitability of the experimental procedure. Metabolism could be affected by factors such as the method of euthanasia of the animals and the sample collection procedures. The effects of these factors on metabolites are tissue-specific. Thus, it is important to select proper methods to sacrifice the animal and appropriate procedures for collecting samples specific to the tissue of interest. Here, we present our protocol to collect specific mouse skeletal muscles with different fiber types for metabolomics studies. We also provide a protocol to measure lactate levels in tissue samples as a way to estimate the metabolic state in collected samples.

  17. Replication protocol analysis: a method for the study of real-world design thinking

    DEFF Research Database (Denmark)

    Galle, Per; Kovacs, L. B.

    1996-01-01

    ’ is refined into a method called ‘replication protocol analysis’ (RPA), and discussed from a methodological perspective of design research. It is argued that for the study of real-world design thinking this method offers distinct advantages over traditional ‘design protocol analysis’, which seeks to capture......Given the brief of an architectural competition on site planning, and the design awarded the first prize, the first author (trained as an architect but not a participant in the competition) produced a line of reasoning that might have led from brief to design. In the paper, such ‘design replication...... the designer’s authentic line of reasoning. To illustrate how RPA can be used, the site planning case is briefly presented, and part of the replicated line of reasoning analysed. One result of the analysis is a glimpse of a ‘logic of design’; another is an insight which sheds new light on Darke’s classical...

  18. Ozone therapy as an adjuvant for endondontic protocols: microbiological - ex vivo study and citotoxicity analyses.

    Science.gov (United States)

    Nogales, Carlos Goes; Ferreira, Marina Beloti; Montemor, Antonio Fernando; Rodrigues, Maria Filomena de Andrade; Lage-Marques, José Luiz; Antoniazzi, João Humberto

    2016-01-01

    This study evaluated the antimicrobial efficacy of ozone therapy in teeth contaminated with Pseudomonas aeruginosa, Enterococcus faecalis, and Staphylococcus aureus using a mono-species biofilm model. Parallel to this, the study aimed to evaluate the cytotoxicity of ozone for human gingival fibroblasts. Material and Methods: One hundred and eighty single-root teeth were contaminated with a mono-species biofilm of Enterococcus faecalis, Pseudomonas aeruginosa, and Staphylococcus aureus. Groups were formed: Group I - control; Group II - standard protocol; Group III - standard protocol + ozone gas at 40 µg/mL; and Group IV - standard protocol + aqueous ozone at 8 µg/mL. In parallel, human gingival fibroblasts were submitted to the MTT test. Cells were plated, then ozone was applied as follows: Group I (control) - broth medium; Group II - aqueous ozone at 2 µg/mL; Group III - aqueous ozone at 5 µg/mL; and Group IV - aqueous ozone at 8 µg/mL. Data were submitted to the Kruskal Wallis test and Bonferroni post hoc analyses to assess microbiology and cytotoxicity, respectively (pozone therapy improved the decontamination of the root canal ex vivo. Ozone was toxic to the cells on first contact, but cell viability was recovered. Thus, these findings suggest that ozone might be useful to improve root canal results.

  19. Severe airway obstruction during surfactant administration using a standardized protocol: a prospective, observational study.

    Science.gov (United States)

    Tarawneh, A; Kaczmarek, J; Bottino, M N; Sant'anna, G M

    2012-04-01

    The objective of this study was to evaluate the occurrence of adverse effects during surfactant delivery, using a standardized protocol for administration and management of complications. The protocol was developed, implemented and used for 6 months. Vital signs and ventilatory parameters were prospectively recorded during the procedure. Infants were classified into three groups, based on the occurrence and severity of complications: no, minor or major. A total of 39 infants received surfactant and 19 presented some complication: 11 minor and 8 major. Six of the major complications were episodes of severe airway obstruction (SAO) and five occurred in extreme low birth weight (ELBW) infants that had more severe lung disease before surfactant delivery. Two cases of persistent pulmonary hypertension occurred in infants with birth weight>1000  g. This study identified a high rate of SAO and provides data to support changes in the protocol, which should include faster and more robust increases in positive inspiratory pressures in ELBW infants presenting with SAO.

  20. Ozone therapy as an adjuvant for endondontic protocols: microbiological – ex vivo study and citotoxicity analyses

    Science.gov (United States)

    NOGALES, Carlos Goes; FERREIRA, Marina Beloti; MONTEMOR, Antonio Fernando; RODRIGUES, Maria Filomena de Andrade; Lage-MARQUES, José Luiz; ANTONIAZZI, João Humberto

    2016-01-01

    ABSTRACT Objectives This study evaluated the antimicrobial efficacy of ozone therapy in teeth contaminated with Pseudomonas aeruginosa, Enterococcus faecalis, and Staphylococcus aureus using a mono-species biofilm model. Parallel to this, the study aimed to evaluate the cytotoxicity of ozone for human gingival fibroblasts. Material and Methods: One hundred and eighty single-root teeth were contaminated with a mono-species biofilm of Enterococcus faecalis, Pseudomonas aeruginosa, and Staphylococcus aureus. Groups were formed: Group I – control; Group II – standard protocol; Group III – standard protocol + ozone gas at 40 µg/mL; and Group IV – standard protocol + aqueous ozone at 8 µg/mL. In parallel, human gingival fibroblasts were submitted to the MTT test. Cells were plated, then ozone was applied as follows: Group I (control) – broth medium; Group II – aqueous ozone at 2 µg/mL; Group III – aqueous ozone at 5 µg/mL; and Group IV – aqueous ozone at 8 µg/mL. Data were submitted to the Kruskal Wallis test and Bonferroni post hoc analyses to assess microbiology and cytotoxicity, respectively (pozone therapy improved the decontamination of the root canal ex vivo. Ozone was toxic to the cells on first contact, but cell viability was recovered. Thus, these findings suggest that ozone might be useful to improve root canal results. PMID:28076466

  1. The Rockefeller University Navigation Program: a structured multidisciplinary protocol development and educational program to advance translational research.

    Science.gov (United States)

    Brassil, Donna; Kost, Rhonda G; Dowd, Kathleen A; Hurley, Arlene M; Rainer, Tyler-Lauren; Coller, Barry S

    2014-02-01

    The development of translational clinical research protocols is complex. To assist investigators, we developed a structured supportive guidance process (Navigation) to expedite protocol development to the standards of good clinical practice (GCP), focusing on research ethics and integrity. Navigation consists of experienced research coordinators leading investigators through a concerted multistep protocol development process from concept initiation to submission of the final protocol. To assess the effectiveness of Navigation, we collect data on the experience of investigators, the intensity of support required for protocol development, IRB review outcomes, and protocol start and completion dates. One hundred forty-four protocols underwent Navigation and achieved IRB approval since the program began in 2007, including 37 led by trainee investigators, 26 led by MDs, 9 by MD/PhDs, 57 by PhDs, and 12 by investigators with other credentials (e.g., RN, MPH). In every year, more than 50% of Navigated protocols were approved by the IRB within 30 days. For trainees who had more than one protocol navigated, the intensity of Navigation support required decreased over time. Navigation can increase access to translational studies for basic scientists, facilitate GCP training for investigators, and accelerate development and approval of protocols of high ethical and scientific quality. © 2014 Wiley Periodicals, Inc.

  2. 77 FR 12312 - Electronic Submission of Nonclinical Study Data; Notice of Pilot Project

    Science.gov (United States)

    2012-02-29

    ... certain biological products and is committed to advancing the public health through innovative activities... 56363, October 3, 2007). The phase 2 pilot was aimed at evaluating animal toxicity data submitted in... transport file (XPT version 5) datasets with data provided in PDF. CBER currently receives nonclinical study...

  3. 77 FR 67823 - Submission for OMB Review; Comment Request: NEXT Generation Health Study; Correction Notice

    Science.gov (United States)

    2012-11-14

    .... adolescents and influences on their health. The study has collected information on adolescent health behaviors... Burden for Affected Public: Young Adults Estimated Estimated Estimated number of Average total annual... response requested Young Adults in NEXT Cohort 2,100 1 1.0 2,100 Peers Recruited by NEXT Plus Young Adults...

  4. Biokemistri: Submissions

    African Journals Online (AJOL)

    Manuscripts may be rejected on the basis of poor English or lack of conformity to accepted standards of style. ORGANIZATION AND FORMAT Regular Papers Regular full-length papers should include the elements described in this section. Title: Each manuscript should present the results of an independent, cohesive study; ...

  5. [Results of applying a fast-track protocol in a colorectal surgery unit: comparative study].

    Science.gov (United States)

    Esteban Collazo, Fernando; Garcia Alonso, Mauricio; Sanz Lopez, Rodrigo; Sanz Ortega, Gonzalo; Ortega Lopez, Mario; Zuloaga Bueno, Jaime; Jimenez Escovar, Fernando; Cerdán Miguel, F Javier

    2012-01-01

    To implement a fast-track (FT) protocol in a colorectal surgery unit, checking its safety when applied to patients subjected to elective colorectal surgery, by evaluating the differences in morbidity and hospital stay compared to a control group with traditional care. We also analyse the functional recovery of the FT group. A prospective cohort study with non-concurrent control, was conducted on a group of 108 patients operated on for colorectal cancer between 2008 and 2009, to which the FT protocol was applied, and a control group (CG) of 147 patients subjected to surgery between 2005 and 2007 with similar characteristics, with traditional postoperative care. The demographic characteristics, anaesthetic risk, and the surgical procedures performed were similar, with a higher number of patients with laparoscopic approach in the FT group. The compliance with the items in our FT protocol was high (72.2-92.6%). Complications were observed in 77 patients (52%) in the GC compared to 30 (27.8%) in the FT group (Psurgery is safe, leading to a significant decrease in morbidity and hospital stay, without increasing the number of readmissions. Copyright © 2011 AEC. Published by Elsevier Espana. All rights reserved.

  6. Proposed computerized protocol for epidemiological study of patients undergoing microsurgery of the larynx

    Directory of Open Access Journals (Sweden)

    Catani, Guilherme Simas do Amaral

    2012-01-01

    Full Text Available Introduction: The merging of medicine with information technology facilitates the retrieval of stored data, aiding the conduct of research with greater scientific rigor. Studies in the field of otorhinolaryngology, specifically in the area of laryngology and voice, are of fundamental importance, since 70% of the economically active need their voice to work. Objective: To create a computerized protocol of the diseases of the larynx, apply and validate it, and use it to evaluate patients undergoing laryngoscopic microsurgery of the larynx. Method: We created a database of ENT diseases through a literature review of textbooks and scientific articles. Next, we computerized the data and incorporated it into the SINPE©, creating a master protocol (ENT diseases and a specific protocol (laryngeal diseases. Data were collected prospectively from patients undergoing laryngeal microsurgery in the ENT Hospital of Paraná. The collected data were analyzed with graphs through the SINPE© Analyzer module. Results: We evaluated 245 patients aged 9-79 years, and determined that 36.61% (93 patients underwent surgery for the presence of polyps on the vocal folds, 12.6% (32 underwent surgery for papillomatosis, and 11.83% (29 underwent surgery for intracordal cysts. Conclusions: The creation of an electronic database of clinical ENT diseases was feasible. We were also able to implement and validate the protocol. The database may be released to physicians involved in clinical data collection and retrieval of information to conduct scientific research in an organized manner. The most common laryngeal disorders identified were polyps, papilloma, and intracordal cysts.

  7. Efficiency of different protocols for enamel clean-up after bracket debonding: an in vitro study

    Directory of Open Access Journals (Sweden)

    Lara Carvalho Freitas Sigilião

    2015-10-01

    Full Text Available Objective: This study aimed to assess the efficiency of six protocols for cleaning-up tooth enamel after bracket debonding.Methods:A total of 60 premolars were divided into six groups, according to the tools used for clean-up: 12-blade bur at low speed (G12L, 12-blade bur at high speed (G12H, 30-blade bur at low speed (G30L, DU10CO ORTHO polisher (GDU, Renew System (GR and Diagloss polisher (GD. Mean roughness (Ra and mean roughness depth (Rz of enamel surface were analyzed with a profilometer. Paired t-test was used to assess Ra and Rz before and after enamel clean-up. ANOVA/Tukey tests were used for intergroup comparison. The duration of removal procedures was recorded. The association between time and variation in enamel roughness (∆Ra, ∆Rz were evaluated by Pearson's correlation test. Enamel topography was assessed by scanning electron microscopy (SEM.Results:In Groups G12L and G12H, original enamel roughness did not change significantly. In Groups G30L, GDU, GR and GD, a smoother surface (p < 0.05 was found after clean-up. In Groups G30L and GD, the protocols used were more time-consuming than those used in the other groups. Negative and moderate correlation was observed between time and (∆Ra, ∆Rz; Ra and (∆Ra, ∆Rz; Rz (r = - 0.445, r = - 0.475, p < 0.01.Conclusion:All enamel clean-up protocols were efficient because they did not result in increased surface roughness. The longer the time spent performing the protocol, the lower the surface roughness.

  8. Automated extraction protocol for quantification of SARS-Coronavirus RNA in serum: an evaluation study

    Directory of Open Access Journals (Sweden)

    Lui Wing-bong

    2006-02-01

    Full Text Available Abstract Background We have previously developed a test for the diagnosis and prognostic assessment of the severe acute respiratory syndrome (SARS based on the detection of the SARS-coronavirus RNA in serum by real-time quantitative reverse transcriptase polymerase chain reaction (RT-PCR. In this study, we evaluated the feasibility of automating the serum RNA extraction procedure in order to increase the throughput of the assay. Methods An automated nucleic acid extraction platform using the MagNA Pure LC instrument (Roche Diagnostics was evaluated. We developed a modified protocol in compliance with the recommended biosafety guidelines from the World Health Organization based on the use of the MagNA Pure total nucleic acid large volume isolation kit for the extraction of SARS-coronavirus RNA. The modified protocol was compared with a column-based extraction kit (QIAamp viral RNA mini kit, Qiagen for quantitative performance, analytical sensitivity and precision. Results The newly developed automated protocol was shown to be free from carry-over contamination and have comparable performance with other standard protocols and kits designed for the MagNA Pure LC instrument. However, the automated method was found to be less sensitive, less precise and led to consistently lower serum SARS-coronavirus concentrations when compared with the column-based extraction method. Conclusion As the diagnostic efficiency and prognostic value of the serum SARS-CoV RNA RT-PCR test is critically associated with the analytical sensitivity and quantitative performance contributed both by the RNA extraction and RT-PCR components of the test, we recommend the use of the column-based manual RNA extraction method.

  9. Proposed computerized protocol for epidemiological study of patients undergoing microsurgery of the larynx

    Science.gov (United States)

    Catani, Guilherme Simas do Amaral; Carvalho, Bettina; Filho, Jorge Massaaki Ido; Filho, Evaldo Dacheux de Macedo; Pinto, José Simão de Paula; Malafaia, Osvaldo; Stahlke, Henrique Jorge

    2012-01-01

    Summary Introduction: The merging of medicine with information technology facilitates the retrieval of stored data, aiding the conduct of research with greater scientific rigor. Studies in the field of otorhinolaryngology, specifically in the area of laryngology and voice, are of fundamental importance, since 70% of the economically active need their voice to work. Objective: To create a computerized protocol of the diseases of the larynx, apply and validate it, and use it to evaluate patients undergoing laryngoscopic microsurgery of the larynx. Method: We created a database of ENT diseases through a literature review of textbooks and scientific articles. Next, we computerized the data and incorporated it into the SINPE©, creating a master protocol (ENT diseases) and a specific protocol (laryngeal diseases). Data were collected prospectively from patients undergoing laryngeal microsurgery in the ENT Hospital of Paraná. The collected data were analyzed with graphs through the SINPE© Analyzer module. Results: We evaluated 245 patients aged 9–79 years, and determined that 36.61% (93 patients) underwent surgery for the presence of polyps on the vocal folds, 12.6% (32) underwent surgery for papillomatosis, and 11.83% (29) underwent surgery for intracordal cysts. Conclusions: The creation of an electronic database of clinical ENT diseases was feasible. We were also able to implement and validate the protocol. The database may be released to physicians involved in clinical data collection and retrieval of information to conduct scientific research in an organized manner. The most common laryngeal disorders identified were polyps, papilloma, and intracordal cysts. PMID:25991956

  10. The Healthy Primary School of the Future: study protocol of a quasi-experimental study

    Directory of Open Access Journals (Sweden)

    M. Willeboordse

    2016-07-01

    nature and sound scientific foundation, these integrated programmes have the potential to form a template for primary schools worldwide. The effects of this approach may extend further than the outcomes associated with well-being and academic achievement, potentially impacting legal and cultural aspects in our society. Trial registration The study protocol was registered in the database ClinicalTrials.gov on 14-06-2016 with the reference number NCT02800616 .

  11. Bridging the gap between comprehensive extraction protocols in plant metabolomics studies and method validation.

    Science.gov (United States)

    Bijttebier, Sebastiaan; Van der Auwera, Anastasia; Foubert, Kenn; Voorspoels, Stefan; Pieters, Luc; Apers, Sandra

    2016-09-07

    It is vital to pay much attention to the design of extraction methods developed for plant metabolomics, as any non-extracted or converted metabolites will greatly affect the overall quality of the metabolomics study. Method validation is however often omitted in plant metabolome studies, as the well-established methodologies for classical targeted analyses such as recovery optimization cannot be strictly applied. The aim of the present study is to thoroughly evaluate state-of-the-art comprehensive extraction protocols for plant metabolomics with liquid chromatography-photodiode array-accurate mass mass spectrometry (LC-PDA-amMS) by bridging the gap with method validation. Validation of an extraction protocol in untargeted plant metabolomics should ideally be accomplished by validating the protocol for all possible outcomes, i.e. for all secondary metabolites potentially present in the plant. In an effort to approach this ideal validation scenario, two plant matrices were selected based on their wide versatility of phytochemicals: meadowsweet (Filipendula ulmaria) for its polyphenols content, and spicy paprika powder (from the genus Capsicum) for its apolar phytochemicals content (carotenoids, phytosterols, capsaicinoids). These matrices were extracted with comprehensive extraction protocols adapted from literature and analysed with a generic LC-PDA-amMS characterization platform that was previously validated for broad range phytochemical analysis. The performance of the comprehensive sample preparation protocols was assessed based on extraction efficiency, repeatability and intermediate precision and on ionization suppression/enhancement evaluation. The manuscript elaborates on the finding that none of the extraction methods allowed to exhaustively extract the metabolites. Furthermore, it is shown that depending on the extraction conditions enzymatic degradation mechanisms can occur. Investigation of the fractions obtained with the different extraction methods

  12. The Sports-Related Injuries and Illnesses in Paralympic Sport Study (SRIIPSS): a study protocol for a prospective longitudinal study.

    Science.gov (United States)

    Fagher, Kristina; Jacobsson, Jenny; Timpka, Toomas; Dahlström, Örjan; Lexell, Jan

    2016-01-01

    Paralympic sport provides sporting opportunities for athletes with a disability, with the Paralympic Games as the main event. Participation in sport is, however, associated with a significant risk for sustaining injuries and illnesses. Our knowledge of sports-related injuries and illnesses in Paralympic sport is very limited and there are no large-scale epidemiological cohort studies. The purpose here is to present a protocol for a prospective longitudinal study: The Sports-Related Injuries and Illnesses in Paralympic Sport Study (SRIIPSS). An argument-based method for investigation of design problems was used to structure the study protocol. The primary requirement of the protocol is to allow prospective studies over time and include exposure to both training and competition. To reflect the complexity of Paralympic sport with athletes' pre-existing impairments, use of assistive equipment, pain and other and medical issues, it is required that the data collection system is specifically adapted to Paralympic sport. To allow the collection of data, at the same time as there is limited access to coaches and medical personnel, it is advantageous that data can be collected online directly from the athletes. Based on this a self-report athlete monitoring system will be developed, where the athletes can enter data weekly via their mobile phones or lap-tops. Data will be collected from around 100 Swedish Paralympic athletes for approximately 1 year, which will allow us to i) prospectively estimate the annual incidence of sports-related injuries and illnesses and ii) explore risk factors and mechanisms for sustaining sports-related injuries and illnesses based on athlete exposure and training loads. For effective implementation of injury and illness prevention measures, comprehensive epidemiological knowledge is required. This study will be the first prospective longitudinal self-report study of sports-related injuries and illnesses in Paralympic sport over a longer period

  13. Exploring interprofessional practices in rapid response systems: a case study protocol.

    Science.gov (United States)

    Allen, Emily; Jackson, Debra; Elliott, Doug

    2015-01-01

    To describe the development of a proposed case study protocol investigating interprofessional relationships in a rapid response system (RRS) in a socioculturally complex clinical environment. Suboptimal care of deteriorating ward patients remains a concern for many acute healthcare organisations. Despite the advent of RRSs, emergency response teams are not always used to their full potential. How and why interprofessional relationships influence practices associated with the care and management of ward patients at risk of clinical deterioration requires investigation. Theoretical and empirical literature describing case study research and RRSs. Review methods An integrative review approach of the literature, focusing on key terms relating to 'case study research' and 'rapid response system', provided context and informed development of the study protocol. A single-site mixed-method instrumental case study protocol was developed using methodological triangulation and a multi-level model to examine interprofessional relationships between a broad range of stakeholders. Concurrent data collection and analysis will occur using document review of clinical scenarios, non-participant observations and semi-structured interviews. Case study research is an effective method for investigating socioculturally complex clinical environments. A strength of this approach is the flexibility in the choice of methods, which allows the researcher to build the design most suitable for the subjects or phenomena being investigated. Although this flexibility may be considered a potential weakness, rigour can be achieved by application of the strategies described. Findings from this research will provide rich descriptive insights into RRS relationships and healthcare professional practices during day-to-day management of acute ward patients at risk of or experiencing clinical deterioration. Description of this structured case study research approach will also inform other researchers.

  14. Deep Brain Stimulation for Tremor Tractographic Versus Traditional (DISTINCT): Study Protocol of a Randomized Controlled Feasibility Trial.

    Science.gov (United States)

    Sajonz, Bastian Elmar Alexander; Amtage, Florian; Reinacher, Peter Christoph; Jenkner, Carolin; Piroth, Tobias; Kätzler, Jürgen; Urbach, Horst; Coenen, Volker Arnd

    2016-12-22

    primary objective is to assess the tremor reduction, obtained by the Fahn-Tolosa-Marin Tremor Rating Scale in the 2 treatment groups. Secondary objectives include (among others) assessing the quality of life, optimal electrode contact positions, and safety of the intervention. The study protocol has been approved by the independent ethics committee of the University of Freiburg. Recruitment to the DISTINCT trial opened in September 2015 and is expected to close in June 2017. At the time of manuscript submission the trial is open to recruitment. The DISTINCT trial is the first to compare DTI tractography-assisted stereotactic surgery with target point of the DRT in general anesthesia to stereotactic surgery of the thalamic/subthalamic region as conventionally used. It can serve as a cornerstone for the evolving technique of DTI tractography-assisted stereotactic surgery. ClinicalTrials.gov NCT02491554; https://clinicaltrials.gov/ct2/show/NCT02491554 (Archived by WebCite at http://www.webcitation.org/6mezLnB9D). German Clinical Trials Register DRKS00008913; http://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00008913 (Archived by WebCite at http://www.webcitation.org/6mezCtxhS).

  15. Why standard brain-computer interface (BCI) training protocols should be changed: an experimental study

    Science.gov (United States)

    Jeunet, Camille; Jahanpour, Emilie; Lotte, Fabien

    2016-06-01

    Objective. While promising, electroencephaloraphy based brain-computer interfaces (BCIs) are barely used due to their lack of reliability: 15% to 30% of users are unable to control a BCI. Standard training protocols may be partly responsible as they do not satisfy recommendations from psychology. Our main objective was to determine in practice to what extent standard training protocols impact users’ motor imagery based BCI (MI-BCI) control performance. Approach. We performed two experiments. The first consisted in evaluating the efficiency of a standard BCI training protocol for the acquisition of non-BCI related skills in a BCI-free context, which enabled us to rule out the possible impact of BCIs on the training outcome. Thus, participants (N = 54) were asked to perform simple motor tasks. The second experiment was aimed at measuring the correlations between motor tasks and MI-BCI performance. The ten best and ten worst performers of the first study were recruited for an MI-BCI experiment during which they had to learn to perform two MI tasks. We also assessed users’ spatial ability and pre-training μ rhythm amplitude, as both have been related to MI-BCI performance in the literature. Main results. Around 17% of the participants were unable to learn to perform the motor tasks, which is close to the BCI illiteracy rate. This suggests that standard training protocols are suboptimal for skill teaching. No correlation was found between motor tasks and MI-BCI performance. However, spatial ability played an important role in MI-BCI performance. In addition, once the spatial ability covariable had been controlled for, using an ANCOVA, it appeared that participants who faced difficulty during the first experiment improved during the second while the others did not. Significance. These studies suggest that (1) standard MI-BCI training protocols are suboptimal for skill teaching, (2) spatial ability is confirmed as impacting on MI-BCI performance, and (3) when faced

  16. Continuous sweep versus discrete step protocols for studying effects of wearable robot assistance magnitude.

    Science.gov (United States)

    Malcolm, Philippe; Rossi, Denise Martineli; Siviy, Christopher; Lee, Sangjun; Quinlivan, Brendan Thomas; Grimmer, Martin; Walsh, Conor J

    2017-07-12

    Different groups developed wearable robots for walking assistance, but there is still a need for methods to quickly tune actuation parameters for each robot and population or sometimes even for individual users. Protocols where parameters are held constant for multiple minutes have traditionally been used for evaluating responses to parameter changes such as metabolic rate or walking symmetry. However, these discrete protocols are time-consuming. Recently, protocols have been proposed where a parameter is changed in a continuous way. The aim of the present study was to compare effects of continuously varying assistance magnitude with a soft exosuit against discrete step conditions. Seven participants walked on a treadmill wearing a soft exosuit that assists plantarflexion and hip flexion. In Continuous-up, peak exosuit ankle moment linearly increased from approximately 0 to 38% of biological moment over 10 min. Continuous-down was the opposite. In Discrete, participants underwent five periods of 5 min with steady peak moment levels distributed over the same range as Continuous-up and Continuous-down. We calculated metabolic rate for the entire Continuous-up and Continuous-down conditions and the last 2 min of each Discrete force level. We compared kinematics, kinetics and metabolic rate between conditions by curve fitting versus peak moment. Reduction in metabolic rate compared to Powered-off was smaller in Continuous-up than in Continuous-down at most peak moment levels, due to physiological dynamics causing metabolic measurements in Continuous-up and Continuous-down to lag behind the values expected during steady-state testing. When evaluating the average slope of metabolic reduction over the entire peak moment range there was no significant difference between Continuous-down and Discrete. Attempting to correct the lag in metabolics by taking the average of Continuous-up and Continuous-down removed all significant differences versus Discrete. For kinematic and

  17. Do federal and state audits increase compliance with a grant program to improve municipal infrastructure (AUDIT study): study protocol for a randomized controlled trial

    National Research Council Canada - National Science Library

    De La O, Ana L; Martel García, Fernando

    2014-01-01

    .... This study protocol for an exploratory randomized controlled trial tests the hypothesis that federal and state audits increase compliance with a federal grant program to improve municipal service...

  18. Where Words Fail, Music Speaks: A Mixed Method Study of an Evidence-Based Music Protocol.

    Science.gov (United States)

    Daniels, Ruby A; Torres, David; Reeser, Cathy

    2016-01-01

    Despite numerous studies documenting the benefits of music, hospice social workers are often unfamiliar with evidence-based music practices that may improve end of life care. This mixed method study tested an intervention to teach hospice social workers and chaplains (N = 10) an evidence-based music protocol. Participants used the evidence-based practice (EBP) for 30 days, recording 226 journal entries that described observations of 84 patients and their families. There was a significant increase in EBP knowledge (35%). Prompting behavioral and emotional responses, music was described frequently as a catalyst that facilitated deeper dialogue between patients, families, social workers, and chaplains.

  19. Systematic Review Protocol to Assess the Effectiveness of Usability Questionnaires in mHealth App Studies.

    Science.gov (United States)

    Zhou, Leming; Bao, Jie; Parmanto, Bambang

    2017-08-01

    Usability questionnaires have a wide use in mobile health (mHealth) app usability studies. However, no systematic review has been conducted for assessing the effectiveness of these questionnaires. This paper describes a protocol for conducting a systematic review of published questionnaire-based mHealth app usability studies. In this systematic review, we will select recently published (2008-2017) articles from peer-reviewed journals and conferences that describe mHealth app usability studies and implement at least one usability questionnaire. The search strategy will include terms such as "mobile app" and "usability." Multiple databases such as PubMed, CINAHL, IEEE Xplore, ACM Digital Library, and INSPEC will be searched. There will be 2 independent reviewers in charge of screening titles and abstracts as well as determining those articles that should be included for a full-text review. The third reviewer will act as a mediator between the other 2 reviewers. Moreover, a data extraction form will be created and used during the full article data analysis. Notably, the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) guidelines will be followed in reporting this protocol. A preliminary search produced 1271 articles, 40 of which are duplicate records. The inclusion-exclusion criteria are being strictly followed in performing the ongoing study selection. Usability questionnaires are an important tool in mHealth app usability studies. This review will summarize the usability questionnaires used in published research articles while assessing the efficacy of these questionnaires in determining the usability of mHealth apps.

  20. A comparative study of routing protocols of heterogeneous wireless sensor networks.

    Science.gov (United States)

    Han, Guangjie; Jiang, Xu; Qian, Aihua; Rodrigues, Joel J P C; Cheng, Long

    2014-01-01

    Recently, heterogeneous wireless sensor network (HWSN) routing protocols have drawn more and more attention. Various HWSN routing protocols have been proposed to improve the performance of HWSNs. Among these protocols, hierarchical HWSN routing protocols can improve the performance of the network significantly. In this paper, we will evaluate three hierarchical HWSN protocols proposed recently--EDFCM, MCR, and EEPCA--together with two previous classical routing protocols--LEACH and SEP. We mainly focus on the round of the first node dies (also called the stable period) and the number of packets sent to sink, which is an important aspect to evaluate the monitoring ability of a protocol. We conduct a lot of experiments and simulations on Matlab to analyze the performance of the five routing protocols.

  1. Optional Protocol on the Sale of Children, Child Prostitution and Child Pornography: A Study on Iran's Accession to the Protocol

    Directory of Open Access Journals (Sweden)

    Seyyed Masoud Noori

    2007-03-01

    Full Text Available Reviewing this Protocol and comparing it with Iranian law, this article seeks to respond to the question of the possible consequences of Iran's accession to the Protocol. Examining the content of the Protocol shows that Iran's accession not only is not in contrary to moral principles, the statutes and the practical procedures of Iranian Government; but it will rather promote Iranian position in the international sphere. بسیاری از پیمان‌نامه‌های مهم بین‏المللی دارای اسناد ضمیمه‌ای به نام پروتکل هستند که موضوعات سند اصلی را تشریح می‌کنند. برای کنوانسیون حقوق کودک نیز که بیش از هر سند بین‌المللی به امضای کشورها رسیده، دو پروتکل الحاقی تدوین شده است: یکی دربارة بکارگیری کودکان در مناقشات مسلّحانه و دیگری دربارة خرید و فروش، خود فروشی و هرزه‌نگاری کودکان. مجلس شورای اسلامی الحاق جمهوری اسلامی ایران به پیمان‌نامة حقوق کودک را تصویب کرده است. یکی از توصیه‌های کمیتة حقوق کودک هنگام بررسی دومین گزارش ادواری ایران این بود که ایران پروتکل‌های مذکور را تصویب کند. مجلس شورای اسلامی در جلسه 9/5/1386 الحاق دولت ایران به پروتکل مربوط به فروش، فحشاء و هرزه‌نگاری کودکان را تصویب کرده است. مقاله حاضر با مروری بر این پروتکل و مطالعة تطبیقی آن با قوانین موضوعة ایران، در صدد است این پرسش را پاسخ گوید که اجابت درخواست کمیتة حقوق کودک و امضای آن پروتکل توسط دولت ایران، چه نتایجی در

  2. African Studies Monographs: Submissions

    African Journals Online (AJOL)

    Privacy Statement. The names and email addresses entered in this journal site will be used exclusively for the stated purposes of this journal and will not be made available for any other purpose or to any other party. ISSN: 1119-7196. AJOL African Journals Online. HOW TO USE AJOL... for Researchers · for Librarians ...

  3. Study protocol. A prospective cohort study of unselected primiparous women: the pregnancy outcome prediction study

    Directory of Open Access Journals (Sweden)

    White Ian R

    2008-11-01

    Full Text Available Abstract Background There have been dramatic changes in the approach to screening for aneuploidy over the last 20 years. However, the approach to screening for other complications of pregnancy such as intra-uterine growth restriction, pre-eclampsia and stillbirth remains largely unchanged. Randomised controlled trials of routine application of high tech screening methods to the general population have generally failed to show improvement in outcome. We have previously reviewed this and concluded it was due, in large part, to poor performance of screening tests. Here, we report a study design where the primary aim is to generate clinically useful methods to screen women to assess their risk of adverse pregnancy outcome. Methods/design We report the design of a prospective cohort study of unselected primiparous women recruited at the time of their first ultrasound scan. Participation involves serial phlebotomy and obstetric ultrasound at the dating ultrasound scan (typically 10–14 weeks, 20 weeks, 28 weeks and 36 weeks gestation. In addition, maternal demographic details are obtained; maternal and paternal height are measured and maternal weight is serially measured during the pregnancy; maternal, paternal and offspring DNA are collected; and, samples of placenta and membranes are collected at birth. Data will be analysed as a prospective cohort study, a case-cohort study, and a nested case-control study. Discussion The study is expected to provide a resource for the identification of novel biomarkers for adverse pregnancy outcome and to evaluate the performance of biomarkers and serial ultrasonography in providing clinically useful prediction of risk.

  4. Impact of introducing multiple evidence-based clinical practice protocols in a medical intensive care unit: a retrospective cohort study

    Directory of Open Access Journals (Sweden)

    Seferian Edward G

    2007-08-01

    Full Text Available Abstract Background Recently completed clinical trials have shown that certain interventions improve the outcome of the critically ill. To facilitate the implementation of these interventions, professional organizations have developed guidelines. Although the impacts of the individual evidence-based interventions have been well described, the overall impact on outcome of introducing multiple evidence-based protocols has not been well studied. The objective of this study was to determine the impact of introducing multiple evidence-based protocols on patient outcome. Methods A retrospective, cohort study of 8,386 patients admitted to the medical intensive care unit (MICU of an academic, tertiary medical center, from January 2000 through June 2005 was performed. Four evidence-based protocols (lung protective strategy for acute lung injury, activated protein C for severe sepsis/septic shock, intravenous insulin for hyperglycemia control and a protocol for sedation/analgesia were introduced in the MICU between February 2002 and April 2004. We considered the time from January 2000 through January 2002 as the pre-protocol period, from February 2002 through March 2004 as the transition period and from April 2004 through June 2005 as the protocol period. We retrieved data including demographics, severity of illness as measured by the Acute Physiology and Chronic Health Evaluation (APACHE III, MICU length of stay and hospital mortality. Student's t, Kruskal-Wallis, Mann-Whitney U, chi square and multiple logistic regression analyses were used to compare differences between groups. P-values Results The predicted mean mortality rates were 20.7%, 21.1% and 21.8%, with the observed mortality rates of 19.3%, 18.0% and 16.9% during the pre-protocol, transition and protocol periods, respectively. Using the pre-protocol period as a reference, the severity-adjusted risk (95% confidence interval of dying was 0.777 (0.655 – 0.922 during the protocol period (P = 0

  5. Ozone therapy as an adjuvant for endondontic protocols: microbiological – ex vivo study and citotoxicity analyses

    Directory of Open Access Journals (Sweden)

    Carlos Goes NOGALES

    Full Text Available ABSTRACT Objectives This study evaluated the antimicrobial efficacy of ozone therapy in teeth contaminated with Pseudomonas aeruginosa, Enterococcus faecalis, and Staphylococcus aureus using a mono-species biofilm model. Parallel to this, the study aimed to evaluate the cytotoxicity of ozone for human gingival fibroblasts. Material and Methods: One hundred and eighty single-root teeth were contaminated with a mono-species biofilm of Enterococcus faecalis, Pseudomonas aeruginosa, and Staphylococcus aureus. Groups were formed: Group I – control; Group II – standard protocol; Group III – standard protocol + ozone gas at 40 µg/mL; and Group IV – standard protocol + aqueous ozone at 8 µg/mL. In parallel, human gingival fibroblasts were submitted to the MTT test. Cells were plated, then ozone was applied as follows: Group I (control – broth medium; Group II – aqueous ozone at 2 µg/mL; Group III – aqueous ozone at 5 µg/mL; and Group IV – aqueous ozone at 8 µg/mL. Data were submitted to the Kruskal Wallis test and Bonferroni post hoc analyses to assess microbiology and cytotoxicity, respectively (p<0.05%. Results The results revealed antimicrobial efficacy by Group IV with no CFU count. The cytotoxicity assay showed Groups III and IV to be the most aggressive, providing a decrease in cell viability at hour 0 from 100% to 77.3% and 68.6%, respectively. Such a decrease in cell viability was reverted, and after 72 hours Groups III and IV provided the greatest increase in cell viability, being statistically different from Groups I and II. Conclusion According to the applied methodology and the limitations of this study, it was possible to conclude that ozone therapy improved the decontamination of the root canal ex vivo. Ozone was toxic to the cells on first contact, but cell viability was recovered. Thus, these findings suggest that ozone might be useful to improve root canal results.

  6. Bee venom acupuncture, NSAIDs or combined treatment for chronic neck pain: study protocol for a randomized, assessor-blind trial

    National Research Council Canada - National Science Library

    Seo, Byung-Kwan; Lee, Jun-Hwan; Kim, Pil-Kun; Baek, Yong-Hyeon; Jo, Dae-Jean; Lee, Sanghun

    2014-01-01

    ... in a rigorous randomized clinical trial (RCT). This pilot study will provide the clinical evidence to evaluate the feasibility and refine the protocol for a full-scale RCT on combined treatment of bee venom acupuncture (BVA...

  7. The safety of a novel early mobilization protocol conducted by ICU physicians: a prospective observational study

    Directory of Open Access Journals (Sweden)

    Keibun Liu

    2018-02-01

    Full Text Available Abstract Background There are numerous barriers to early mobilization (EM in a resource-limited intensive care unit (ICU without a specialized team or an EM culture, regarding patient stability while critically ill or in the presence of medical devices. We hypothesized that ICU physicians can overcome these barriers. The aim of this study was to investigate the safety of EM according to the Maebashi EM protocol conducted by ICU physicians. Methods This was a single-center prospective observational study. All consecutive patients with an unplanned emergency admission were included in this study, according to the exclusion criteria. The observation period was from June 2015 to June 2016. Data regarding adverse events, medical devices in place during rehabilitation, protocol adherence, and rehabilitation outcomes were collected. The primary outcome was safety. Results A total of 232 consecutively enrolled patients underwent 587 rehabilitation sessions. Thirteen adverse events occurred (2.2%; 95% confidence interval, 1.2–3.8% and no specific treatment was needed. There were no instances of dislodgement or obstruction of medical devices, tubes, or lines. The incidence of adverse events associated with mechanical ventilation or extracorporeal membrane oxygenation (ECMO was 2.4 and 3.6%, respectively. Of 587 sessions, 387 (66% sessions were performed at the active rehabilitation level, including sitting out of the bed, active transfer to a chair, standing, marching, and ambulating. ICU physicians attended over 95% of these active rehabilitation sessions. Of all patients, 143 (62% got out of bed within 2 days (median 1.2 days; interquartile range 0.1–2.0. Conclusions EM according to the Maebashi EM protocol conducted by ICU physicians, without a specialized team or EM culture, was performed at a level of safety similar to previous studies performed by specialized teams, even with medical devices in place, including mechanical ventilation or ECMO

  8. Osteopathic manipulative treatment and pain in preterms: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Cerritelli, Francesco; Cicchitti, Luca; Martelli, Marta; Barlafante, Gina; Renzetti, Cinzia; Pizzolorusso, Gianfranco; Lupacchini, Mariacristina; D'Orazio, Marianna; Marinelli, Benedetta; Cozzolino, Vincenzo; Fusilli, Paola; D'Incecco, Carmine

    2015-03-08

    Recent evidence proved the necessity to improve health care and pain management in newborns. Osteopathic manipulative treatment (OMT) has been largely used to treat painful syndromes as well as term and preterm newborns. Recent studies have demonstrated positive results of osteopathy in reducing length of stay and costs. However, no trials were carried out on pain in newborns. The aim of the present clinical trial is to explore the effectiveness of osteopathic treatment in reducing pain in a sample of preterms. A three-armed single blinded placebo-control randomised controlled trial protocol has been designed to primarily evaluate the extent to which OMT is effective in reducing pain in preterms. One hundred and twenty newborns will be enrolled from one tertiary neonatal intensive care unit in central Italy and randomised in three groups: study, sham and control. The study group will be further prospectively randomised in two subgroups: experienced osteopaths and students. All preterms will receive standard medical care. Osteopathic treatment will be applied to the study group only whilst 'soft touch' will be administer to the sham group only. Newborns will undergo manual sessions once a week for the entire period of hospitalisation. Blinding will be assured for neonatal staff and outcome assessor. Primary outcome will be the mean difference in baseline score changes of PIPP questionnaire between discharge and entry among the three groups. Secondary outcomes will be: mean difference in length of stay and costs between groups. Statistical analyses will use per-protocol analysis method. Missing data will be handled using last observation carried forward imputation technique. The present single blinded randomised controlled trial has been designed to explore potential advantages of OMT in the management of newborns' pain. Currently, based on a patient-centred need-based approach, this research will be looking at the benefit of osteopathic care rather than the efficacy

  9. Recruitment of heterosexual couples in public health research: a study protocol

    Directory of Open Access Journals (Sweden)

    Pouget Enrique R

    2003-10-01

    Full Text Available Abstract Background Public health research involving social or kin groups (such as sexual partners or family members, rather than samples of unrelated individuals, has become more widespread in response to social ecological approaches to disease treatment and prevention. This approach requires the development of innovative sampling, recruitment and screening methodologies tailored to the study of related individuals. Methods In this paper, we describe a set of sampling, recruitment and screening protocols developed to enlist urban, drug-using, heterosexual couples into a public health research study. This population is especially hard to reach because they are engaged in illegal and/or stigmatized behaviors. The protocols were designed to integrate adaptive sampling, street- and referral-based recruitment, and screening procedures to verify study eligibility and relationship status. Discussion Recruitment of heterosexual couples through one partner, preferably the female, can be an effective enlistment technique. Verification of relationship status is an important component of dyadic research. Comparison of parallel questionnaires administered to each member of a dyad can aid in the assessment of relationship status. However, multiple independent sources of information should be used to verify relationship status when available. Adaptive sampling techniques were effective in reaching drug-using heterosexual couples in an urban setting, and the application of these methods to other groups of related individuals in clinical and public health research may prove to be useful. However, care must be taken to consider potential sources of sampling bias when interpreting and generalizing study results.

  10. Iatrogenic newborn weight loss: knowledge translation using a study protocol for your maternity setting

    Directory of Open Access Journals (Sweden)

    Woodend A Kirsten

    2011-08-01

    Full Text Available Abstract Background In our original study of newborn weight loss, we determined there were positive correlations among newborn weight loss, neonatal output, and the IV fluids mothers received before their babies' birth. Basically, an increase in maternal IV fluids is correlated to an increase in neonatal output and newborn weight loss. When assessing newborn weight change, our recommendation is to change baseline from birth weight to a weight measured at 24 hours. The purpose of this paper is to provide a protocol for clinicians to collect and analyze data from their own maternity site to determine if the newborns experience such an iatrogenic weight loss and to make decisions about how to assess newborn weight changes. Methods We recommend a prospective observational study with data collected about maternal fluids, neonatal output, and newborn weight measurements. The methods we suggest include specifics about recruitment, data collection, and data analysis. Discussion Quality assurance and research ethics considerations are described. We also share practical information that we learned from our original study. Ultimately, to encourage knowledge translation and research uptake, we provide a protocol and sound advice to do a research study in your maternity setting.

  11. Effectiveness of additional trunk exercises on gait performance: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Van Criekinge, Tamaya; Saeys, Wim; Hallemans, Ann; Vereeck, Luc; De Hertogh, Willem; Van de Walle, Patricia; Vaes, Nathalie; Lafosse, Christophe; Truijen, Steven

    2017-06-02

    Evidence is lacking concerning the effect of additional trunk rehabilitation on gait performance. Investigating gait performance by both clinical and biomechanical outcome measures might lead to new scientific insights into the importance of the trunk during gait rehabilitation in people suffering from stroke. This protocol was written according to the SPIRIT 2013 Statement. An assessor-blinded randomized controlled trial will be conducted in patients with impaired trunk control after stroke. A total of 60 patients will be randomly allocated to the control or the experimental group by means of sealed opaque envelopes. They will receive either 16 h of additional trunk exercises (experimental group) or cognitive exercises (controls) for 1 h a day, 4 days a week for 4 weeks. Patients will also receive 2 h of standard care consisting of physiotherapy and occupational therapy. Gait performance will be assessed clinically by the Tinetti Test and biomechanically by means of a full body gait analysis. In addition, the effect of the exercise protocol on the trunk itself and trunk activities of daily living will be assessed by the Trunk Impairment Scale and the Barthel Index. Despite the evidence demonstrating the importance of trunk control after stroke, studies about the effects of trunk rehabilitation on gait performance are inconsistent. In the current study, a more sophisticated treatment protocol will be used to enlarge therapeutic improvements, the relationship between clinical and biomechanical measures of gait performance can be investigated, and the sustainability of the effects of trunk exercises over time will be examined. Since clinical improvements are of greater importance to patients and physiotherapists, clinical assessment scales will be used as primary outcome measures. ClinicalTrials.gov, ID: NCT02708888 . Registered on 2 March 2016.

  12. Estimations of isoprenoid emission capacity from enclosure studies: measurements, data processing, quality and standardized measurement protocols

    Directory of Open Access Journals (Sweden)

    Ü. Niinemets

    2011-08-01

    Full Text Available The capacity for volatile isoprenoid production under standardized environmental conditions at a certain time (ES, the emission factor is a key characteristic in constructing isoprenoid emission inventories. However, there is large variation in published ES estimates for any given species partly driven by dynamic modifications in ES due to acclimation and stress responses. Here we review additional sources of variation in ES estimates that are due to measurement and analytical techniques and calculation and averaging procedures, and demonstrate that estimations of ES critically depend on applied experimental protocols and on data processing and reporting. A great variety of experimental setups has been used in the past, contributing to study-to-study variations in ES estimates. We suggest that past experimental data should be distributed into broad quality classes depending on whether the data can or cannot be considered quantitative based on rigorous experimental standards. Apart from analytical issues, the accuracy of ES values is strongly driven by extrapolation and integration errors introduced during data processing. Additional sources of error, especially in meta-database construction, can further arise from inconsistent use of units and expression bases of ES. We propose a standardized experimental protocol for BVOC estimations and highlight basic meta-information that we strongly recommend to report with any ES measurement. We conclude that standardization of experimental and calculation protocols and critical examination of past reports is essential for development of accurate emission factor databases.

  13. Comparison between stress myocardial perfusion SPECT recorded with cadmium-zinc-telluride and Anger cameras in various study protocols

    Energy Technology Data Exchange (ETDEWEB)

    Verger, Antoine; Karcher, Gilles [CHU-Nancy, Department of Nuclear Medicine, Nancy (France); INSERM U947, Nancy (France); Nancyclotep Experimental Imaging Platform, Nancy (France); Djaballah, Wassila [CHU-Nancy, Department of Nuclear Medicine, Nancy (France); INSERM U947, Nancy (France); Fourquet, Nicolas [Clinique Pasteur, Toulouse (France); Rouzet, Francois; Le Guludec, Dominique [AP-HP, Hopital Bichat, Department of Nuclear Medicine, Paris (France); INSERM U 773 Inserm and Denis Diderot University, Paris (France); Koehl, Gregoire; Roch, Veronique [CHU-Nancy, Department of Nuclear Medicine, Nancy (France); Nancyclotep Experimental Imaging Platform, Nancy (France); Imbert, Laetitia [CHU-Nancy, Department of Nuclear Medicine, Nancy (France); Nancyclotep Experimental Imaging Platform, Nancy (France); Centre Alexis Vautrin, Department of Radiotherapy, Vandoeuvre (France); Poussier, Sylvain [INSERM U947, Nancy (France); Nancyclotep Experimental Imaging Platform, Nancy (France); Fay, Renaud [INSERM, Centre d' Investigation Clinique CIC-P 9501, Nancy (France); Marie, Pierre-Yves [CHU-Nancy, Department of Nuclear Medicine, Nancy (France); Nancyclotep Experimental Imaging Platform, Nancy (France); INSERM U961, Nancy (France); Hopital de Brabois, CHU-Nancy, Medecine Nucleaire, Vandoeuvre-les-Nancy (France)

    2013-03-15

    The results of stress myocardial perfusion SPECT could be enhanced by new cadmium-zinc-telluride (CZT) cameras, although differences compared to the results with conventional Anger cameras remain poorly known for most study protocols. This study was aimed at comparing the results of CZT and Anger SPECT according to various study protocols while taking into account the influence of obesity. The study population, which was from three different institutions equipped with identical CZT cameras, comprised 276 patients referred for study using protocols involving {sup 201}Tl (n = 120) or {sup 99m}Tc-sestamibi injected at low dose at stress ({sup 99m}Tc-Low; stress/rest 1-day protocol; n = 110) or at high dose at stress ({sup 99m}Tc-High; rest/stress 1-day or 2-day protocol; n = 46). Each Anger SPECT scan was followed by a high-speed CZT SPECT scan (2 to 4 min). Agreement rates between CZT and Anger SPECT were good irrespective of the study protocol (for abnormal SPECT, {sup 201}Tl 92 %, {sup 99m}Tc-Low 86 %, {sup 99m}Tc-High 98 %), although quality scores were much higher for CZT SPECT with all study protocols. Overall correlations were high for the extent of myocardial infarction (r = 0.80) and a little lower for ischaemic areas (r = 0.72), the latter being larger on Anger SPECT (p < 0.001). This larger extent was mainly observed in 50 obese patients who were in the {sup 201}Tl or {sup 99m}Tc-Low group and in whom stress myocardial counts were particularly low with Anger SPECT (228 {+-} 101 kcounts) and dramatically enhanced with CZT SPECT (+279 {+-} 251 %). Concordance between the results of CZT and Anger SPECT is good regardless of study protocol and especially when excluding obese patients who have low-count Anger SPECT and for whom myocardial counts are dramatically enhanced on CZT SPECT. (orig.)

  14. Postpartum physiology, psychology and paediatric follow up study (P4 Study) - Study protocol.

    Science.gov (United States)

    Davis, Gregory K; Roberts, Lynne; Mangos, George; Henry, Amanda; Pettit, Franziska; O'Sullivan, Anthony; Homer, Caroline S E; Craig, Maria; Harvey, Samuel B; Brown, Mark A

    2016-10-01

    Women who have had hypertension in pregnancy are at greater risk of long term cardiovascular disease (CVD). Little is known about their cardiovascular risk postpartum or the effects on the woman's mental health and the outcomes of their infants. In this project we will study the physiological and psychological health of women and the physical health and development of their infants six months, two years and five years after birth. We will establish normal blood pressure (BP) and metabolic function for women who were normotensive in pregnancy and use these to assess women who had gestational hypertension (GH) or preeclampsia (PE). Women will be asked to participate if they have given birth in the preceding six months. They will be excluded if they had diabetes, hypertension, renal or other serious maternal disease prior to pregnancy or congenital anomaly in the pregnancy. We will recruit 292 women who were normotensive and their babies, 100 who had GH and 100 who had PE and their babies. They will be assessed at six months, two and five years after birth. At each assessment mothers will have their blood pressure (BP) assessed peripherally with a liquid crystal sphygmomanometer and 24h ambulatory blood pressure monitoring (ABPM), and centrally with non-invasive applanation tonometry. Additional physiological testing will include: body composition; energy balance; vascular compliance; cardiac function; liver and renal function, lipids and biochemistry; glucose and insulin; and urinalysis. Psychological status will be assessed with validated self-report questionnaires for depression, anxiety, post-traumatic stress disorder (PTSD) and mother-infant bonding. The babies will have a medical examination by a paediatrician at each assessment. Their behavioural development will be assessed with an Ages and Stages Questionnaire completed by their mother at each assessment and a developmental assessment by a child psychologist at two and five years. This study will re

  15. The "Healthy Habits, Healthy Girls" randomized controlled trial for girls: study design, protocol, and baseline results.

    Science.gov (United States)

    Leme, Ana Carolina Barco; Philippi, Sonia Tucunduva

    2015-07-01

    The purpose of this article is to describe the study design, protocol, and baseline results of the "Healthy Habits, Healthy Girls" program. The intervention is being evaluated through a randomized controlled trial in 10 public schools in the city of São Paulo, Brazil. Data on the following variables were collected and assessed at baseline and will be reevaluated at 7 and 12 months: body mass index, waist circumference, dietary intake, nutrition, physical activity, social cognitive mediators, physical activity level, sedentary behaviors, self-rated physical status, and overall self-esteem. According to the baseline results, 32.4% and 23.4% of girls were overweight in the intervention and control groups, respectively, and in both groups a higher percentage failed to meet daily recommendations for moderate and vigorous physical activity and maximum screen time (TV, computer, mobile devices). There were no significant differences between the groups for most of the variables, except age (p = 0.000) and waist circumference (p = 0.014). The study showed a gap in the Brazilian literature on protocols for randomized controlled trials to prevent obesity among youth. The current study may thus be an important initial contribution to the field.

  16. Supporting Tablet Configuration, Tracking, and Infection Control Practices in Digital Health Interventions: Study Protocol.

    Science.gov (United States)

    Furberg, Robert D; Ortiz, Alexa M; Zulkiewicz, Brittany A; Hudson, Jordan P; Taylor, Olivia M; Lewis, Megan A

    2016-06-27

    Tablet-based health care interventions have the potential to encourage patient care in a timelier manner, allow physicians convenient access to patient records, and provide an improved method for patient education. However, along with the continued adoption of tablet technologies, there is a concomitant need to develop protocols focusing on the configuration, management, and maintenance of these devices within the health care setting to support the conduct of clinical research. Develop three protocols to support tablet configuration, tablet management, and tablet maintenance. The Configurator software, Tile technology, and current infection control recommendations were employed to develop three distinct protocols for tablet-based digital health interventions. Configurator is a mobile device management software specifically for iPhone operating system (iOS) devices. The capabilities and current applications of Configurator were reviewed and used to develop the protocol to support device configuration. Tile is a tracking tag associated with a free mobile app available for iOS and Android devices. The features associated with Tile were evaluated and used to develop the Tile protocol to support tablet management. Furthermore, current recommendations on preventing health care-related infections were reviewed to develop the infection control protocol to support tablet maintenance. This article provides three protocols: the Configurator protocol, the Tile protocol, and the infection control protocol. These protocols can help to ensure consistent implementation of tablet-based interventions, enhance fidelity when employing tablets for research purposes, and serve as a guide for tablet deployments within clinical settings.

  17. The FLASSH study: protocol for a randomised controlled trial evaluating falls prevention after stroke and two sub-studies

    OpenAIRE

    Mackintosh Shylie F; Hill Keith D; Batchelor Frances A; Said Catherine M; Whitehead Craig H

    2009-01-01

    Abstract Background Falls are common in stroke survivors returning home after rehabilitation, however there is currently a lack of evidence about preventing falls in this population. This paper describes the study protocol for the FLASSH (FaLls prevention After Stroke Survivors return Home) project. Methods and design This randomised controlled trial aims to evaluate the effectiveness of a multi-factorial falls prevention program for stroke survivors who are at high risk of falling when they ...

  18. A comparative study of protocols for mouse embryonic stem cell culturing.

    Directory of Open Access Journals (Sweden)

    Christoffer Tamm

    Full Text Available Most stem cell laboratories still rely on old culture methods to support the expansion and maintenance of mouse embryonic stem (ES cells. These involve growing cells on mouse embryonic fibroblast feeder cells or on gelatin in media supplemented with fetal bovine serum and leukemia inhibitory factor (LIF. However, these techniques have several drawbacks including the need for feeder-cells and/or use of undefined media containing animal derived components. Culture of stem cells under undefined conditions can induce spontaneous differentiation and reduce reproducibility of experiments. In recent years several new ES cell culture protocols, using more well-defined conditions, have been published and we have compared the standard culture protocols with two of the newly described ones: 1 growing cells in semi-adherence in a medium containing two small molecule inhibitors (CHIR99021, PD0325901 and; 2 growing cells in a spheroid suspension culture in a defined medium containing LIF and bFGF. Two feeder-dependent mouse ES (mES cell lines and two cell lines adapted to feeder-independent growth were used in the study. The overall aim has not only been to compare self-renewal and differentiation capacity, but also ease-of-use and cost efficiency. We show that mES cells when grown adherently proliferate much faster than when grown in suspension as free-floating spheres, independent of media used. Although all the tested culture protocols could maintain sustained pluripotency after prolonged culturing, our data confirm previous reports showing that the media containing two chemical inhibitors generate more pure stem cell cultures with negligible signs of spontaneous differentiation as compared to standard mES media. Furthermore, we show that this medium effectively rescues and cleans up cultures that have started to deteriorate, as well as allow for effective adaption of feeder-dependent mES cell lines to be maintained in feeder-free conditions.

  19. Optimization of the protocols for the use of contrast agents in PET/CT studies.

    Science.gov (United States)

    Pelegrí Martínez, L; Kohan, A A; Vercher Conejero, J L

    The introduction of PET/CT scanners in clinical practice in 1998 has improved care for oncologic patients throughout the clinical pathway, from the initial diagnosis of disease through the evaluation of the response to treatment to screening for possible recurrence. The CT component of a PET/CT study is used to correct the attenuation of PET studies; CT also provides anatomic information about the distribution of the radiotracer. CT is especially useful in situations where PET alone can lead to false positives and false negatives, and CT thereby improves the diagnostic performance of PET. The use of intravenous or oral contrast agents and optimal CT protocols have improved the detection and characterization of lesions. However, there are circumstances in which the systematic use of contrast agents is not justified. The standard acquisition in PET/CT scanners is the whole body protocol, but this can lead to artifacts due to the position of patients and respiratory movements between the CT and PET acquisitions. This article discusses these aspects from a constructive perspective with the aim of maximizing the diagnostic potential of PET/CT and providing better care for patients. Copyright © 2016 SERAM. Publicado por Elsevier España, S.L.U. All rights reserved.

  20. Tanzania Veterinary Journal: Submissions

    African Journals Online (AJOL)

    The corresponding author certifies in the letter that all coauthors have read the manuscript and agree to its submission. Every coauthor should .... If you will be using a digital camera to capture images for print production, you must use the highest resolution setting option with the least amount of compression. Digital camera ...

  1. ORiON: Submissions

    African Journals Online (AJOL)

    This format is also supported by the ORiON LATEX style sheet (which may be downloaded from http://www.orssa.org.za -> ORiON -> Submissions -> Style Sheets). ... If MS Word is used to prepare a manuscript, it should be utilised appropriately. .... An example of an unpublished technical report [6] is also shown below.

  2. Nigerian Veterinary Journal: Submissions

    African Journals Online (AJOL)

    SCOPE The Editorial Board of the Nigerian Veterinary Journal (NVJ) welcomes contributions in the form of original research papers, review articles, clinical case reports, and short communications on all aspects of Veterinary Medicine, Surgery and Animal Production. Submissions are accepted on the understanding that ...

  3. Open Veterinary Journal: Submissions

    African Journals Online (AJOL)

    All submitted manuscripts are checked for plagiarism using PlagScan Plagiarism Detection Software: The image shows our cooperation with the online plagiarism detection service PlagScan. Submission ... For case reports, text should be organized as follows: Introduction, Case Details, Discussion, and References. Review ...

  4. Ergonomics SA: Submissions

    African Journals Online (AJOL)

    Manuscript submissions. Authors should submit their full papers (using the abovementioned template) as an attachment via email to the journal email address j.mcdougall@ru.ac.za. All submitted papers should be sent in .doc or .rtf formats. No other formats will be accepted. Editor. Editor-in-Chief: Ergonomics SA

  5. Manuscript Submission Form

    Indian Academy of Sciences (India)

    Mr.XAVIER

    To: Indian Academy of Sciences. From: Author or Corresponding author with institutional/corresponding address including e-mail. (on behalf of, and binding upon, all the authors). Journal: Title of manuscript: Date of submission of manuscript: In respect of the work mentioned above, I/we undertake to ensure that: i).

  6. Lagos Historical Review: Submissions

    African Journals Online (AJOL)

    Submissions can be made by sending a word processing computer file in MS Word format by e-mail to sarlek@yahoo.com, or by mailing three paper copies to the Editorial Office. Authors should keep a computer file version of their manuscript, as Lagos Historical Review will require a disk version upon acceptance for ...

  7. Africa Sanguine: Submissions

    African Journals Online (AJOL)

    Author Guidelines. Submissions for consideration may include original scientific articles (which will be peer reviewed), short reports, letters to the Editor, reviews, congress proceedings, and reprints of published articles (with permission). Original scientific work must meet the following requirements: Be a report of original ...

  8. A Comprehensive study of a New Multipath Energy Aware Routing Protocol for Mobile Ad-hoc Networks

    OpenAIRE

    Chettibi, Saloua

    2009-01-01

    S. Chettibi, M. Benmohammed, "A comprehensive study of a new multipath energy aware routing protocol for mobile ad-hoc networks"; International Conference on Systems and Information Processing, ICSIP'09, May 02 – 04, 2009, Guelma, Algeria; Maximizing network lifetime is a very challenging issue in routing protocol design for Mobile Ad-hoc NETworks (MANETs), since mobile nodes are powered by limited-capacity batteries. Furthermore, replacing or recharging batteries is often impossible in criti...

  9. The German AugUR study: study protocol of a prospective study to investigate chronic diseases in the elderly.

    Science.gov (United States)

    Stark, Klaus; Olden, Matthias; Brandl, Caroline; Dietl, Alexander; Zimmermann, Martina E; Schelter, Sabine C; Loss, Julika; Leitzmann, Michael F; Böger, Carsten A; Luchner, Andreas; Kronenberg, Florian; Helbig, Horst; Weber, Bernhard H F; Heid, Iris M

    2015-10-21

    The majority of patients suffering from chronic health disabilities is beyond 70 years of age. Typical late-onset chronic diseases include those affecting the heart, the kidney, cancer, and conditions of the eye such as age-related macular degeneration. These diseases disable patients for many years and largely compromise autonomy in daily life. Due to challenges in recruiting the elderly, the collection of population-based epidemiological data as a prerequisite to understand associated risk factors and mechanisms is commonly done in the general population within an age-range of 20 to 70 years. We establish the German AugUR study (Age-related diseases: understanding genetic and non-genetic influences - a study at the University of Regensburg), a prospective study in the mobile elderly general population in and around Regensburg in eastern Bavaria. In the long term, we aim to recruit 3,000 persons of Caucasian ethnicity with at least 70 years of age via residents' registration offices and conduct 3-year follow-ups. The study protocol includes a standardized interview regarding social and life-style factors, medication history, quality-of-life, and existing diagnoses of common diseases. The participants undergo medical examinations for ophthalmological, cardiovascular or diabetes-related conditions, and general measurements of body shape and fitness. The program is particularly tailored for the elderly. Biobanking of whole blood, serum, plasma, and urine is conducted and standard laboratory measurements are performed in fresh samples. AugUR is specifically designed as a research platform to host studies of late onset diseases. Consequently, this platform will help (1) to unravel the genetic and non-genetic etiology of disease development and progression, (2) to serve as control group of elderly individuals for comparisons with various patient groups, (3) to derive prevalence and incidence data on chronic diseases, and (4) to provide clinical reference parameters

  10. Real-Time QoS Routing Protocols in Wireless Multimedia Sensor Networks: Study and Analysis.

    Science.gov (United States)

    Alanazi, Adwan; Elleithy, Khaled

    2015-09-02

    Many routing protocols have been proposed for wireless sensor networks. These routing protocols are almost always based on energy efficiency. However, recent advances in complementary metal-oxide semiconductor (CMOS) cameras and small microphones have led to the development of Wireless Multimedia Sensor Networks (WMSN) as a class of wireless sensor networks which pose additional challenges. The transmission of imaging and video data needs routing protocols with both energy efficiency and Quality of Service (QoS) characteristics in order to guarantee the efficient use of the sensor nodes and effective access to the collected data. Also, with integration of real time applications in Wireless Senor Networks (WSNs), the use of QoS routing protocols is not only becoming a significant topic, but is also gaining the attention of researchers. In designing an efficient QoS routing protocol, the reliability and guarantee of end-to-end delay are critical events while conserving energy. Thus, considerable research has been focused on designing energy efficient and robust QoS routing protocols. In this paper, we present a state of the art research work based on real-time QoS routing protocols for WMSNs that have already been proposed. This paper categorizes the real-time QoS routing protocols into probabilistic and deterministic protocols. In addition, both categories are classified into soft and hard real time protocols by highlighting the QoS issues including the limitations and features of each protocol. Furthermore, we have compared the performance of mobility-aware query based real-time QoS routing protocols from each category using Network Simulator-2 (NS2). This paper also focuses on the design challenges and future research directions as well as highlights the characteristics of each QoS routing protocol.

  11. Randomized controlled trial on the effectiveness of a multicomponent intervention on migraine: A study protocol.

    Science.gov (United States)

    Renjith, Vishnu; Pai, Aparna; Radhakrishnan, Kurupath; Nayak, Baby S; Devi, Elsa Sanatombi; Ladd, Elissa; George, Anice

    2017-10-11

    To describe a randomized controlled trial protocol that evaluates the effectiveness of a multicomponent intervention in improving the outcomes (quality of life, disability, intensity, frequency and duration) of patients with migraine. Migraine affects various facets of Quality of Life and results in moderate to high levels of disability among migraineurs. Migraine pain can be intense and unremitting that can interfere with the daily routine and reduce the ability to think and function normally. Many people can lower their risk of a migraine by simply avoiding stress, getting enough sleep, eating regularly and by avoiding triggers. Hence, the present study aims at evaluating the effectiveness of a multicomponent intervention in managing migraine headaches. The multicomponent intervention includes behavioural lifestyle modification program and sessions of pranayama (a form of yogic breathing exercise). The study is a prospective, randomized, controlled, single-blinded trial with parallel arms. The study participants are randomized to intervention and control arms. The participants randomized to the intervention arm would receive the specific multicomponent intervention based on the protocol. The participants in the control arm would receive routine care. They are followed up for 24 weeks and the outcomes are assessed. Various studies report that non-pharmacological therapies and integrative therapies play a major role in the management of migraine headaches. The findings of the study are expected to open up new horizons in health care arena emphasizing the use of non-pharmacological therapy for less focused areas of primary care health problems such as migraine. The trial is registered with the Clinical Trials Registry India (CTRI). The CTRI India is one of the primary registries in the WHO registry network (Ctri.nic.in, ). CTRI reference ID: CTRI/2015/10/006282. © 2017 John Wiley & Sons Ltd.

  12. Developing a Taxonomy of Dark Triad Triggers at Work - A Grounded Theory Study Protocol.

    Science.gov (United States)

    Nübold, Annika; Bader, Josef; Bozin, Nera; Depala, Romil; Eidast, Helena; Johannessen, Elisabeth A; Prinz, Gerhard

    2017-01-01

    In past years, research and corporate scandals have evidenced the destructive effects of the dark triad at work, consisting of narcissism (extreme self-centeredness), psychopathy (lack of empathy and remorse) and Machiavellianism (a sense of duplicity and manipulativeness). The dark triad dimensions have typically been conceptualized as stable personality traits, ignoring the accumulating evidence that momentary personality expressions - personality states - may change due to the characteristics of the situation. The present research protocol describes a qualitative study that aims to identify triggers of dark triad states at work by following a grounded theory approach using semi-structured interviews. By building a comprehensive categorization of dark triad triggers at work scholars may study these triggers in a parsimonious and structured way and organizations may derive more effective interventions to buffer or prevent the detrimental effects of dark personality at work.

  13. Developing a Taxonomy of Dark Triad Triggers at Work – A Grounded Theory Study Protocol

    Science.gov (United States)

    Nübold, Annika; Bader, Josef; Bozin, Nera; Depala, Romil; Eidast, Helena; Johannessen, Elisabeth A.; Prinz, Gerhard

    2017-01-01

    In past years, research and corporate scandals have evidenced the destructive effects of the dark triad at work, consisting of narcissism (extreme self-centeredness), psychopathy (lack of empathy and remorse) and Machiavellianism (a sense of duplicity and manipulativeness). The dark triad dimensions have typically been conceptualized as stable personality traits, ignoring the accumulating evidence that momentary personality expressions – personality states – may change due to the characteristics of the situation. The present research protocol describes a qualitative study that aims to identify triggers of dark triad states at work by following a grounded theory approach using semi-structured interviews. By building a comprehensive categorization of dark triad triggers at work scholars may study these triggers in a parsimonious and structured way and organizations may derive more effective interventions to buffer or prevent the detrimental effects of dark personality at work. PMID:28326048

  14. Assessing the Efficacy of an App-Based Method of Family Planning: The Dot Study Protocol.

    Science.gov (United States)

    Simmons, Rebecca G; Shattuck, Dominick C; Jennings, Victoria H

    2017-01-18

    assess pregnancy status over time. This paper outlines the protocol for this efficacy trial, following the Standard Protocol Items: Recommendations for Intervention Trials checklist, to provide an overview of the rationale, methodology, and analysis plan. Participants will be asked to provide daily sexual history data and periodically answer surveys administered through a call center or directly on their phone. Funding for the study was provided in 2013 under the United States Agency for International Development Fertility Awareness for Community Transformation project. Recruitment for the study will begin in January of 2017. The study is expected to last approximately 18 months, depending on recruitment. Findings on the study's primary outcomes are expected to be finalized by September 2018. Reproducibility and transparency, important aspects of all research, are particularly critical in developing new approaches to research design. This protocol outlines the first study to prospectively test both the efficacy (correct use) and effectiveness (actual use) of a pregnancy prevention app. This protocol and the processes it describes reflect the dynamic integration of mobile technologies, a call center, and Health Insurance Portability and Accountability Act-compliant study procedures. Future fertility app studies can build on our approaches to develop methodologies that can contribute to the evidence base around app-based methods of contraception. ClinicalTrials.gov NCT02833922; https://clinicaltrials.gov/ct2/show/NCT02833922 (Archived be WebCite at http://www.webcitation.org/6nDkr0e76).

  15. A Study on the Distributed Antenna Based Heterogeneous Cognitive Wireless Network Synchronous MAC Protocol

    Directory of Open Access Journals (Sweden)

    Lian-Fen Huang

    2015-01-01

    Full Text Available This paper introduces distributed antennas into a cognitive radio network and presents a heterogeneous network. The best contribution of this paper is that it designs a synchronous cognitive MAC protocol (DAHCWNS-MAC protocol: distributed antenna based heterogeneous cognitive wireless network synchronous MAC protocol. The novel protocol aims at combining the advantages of cognitive radio and distributed antennas to fully utilize the licensed spectrum, broaden the communication range, and improve throughput. This paper carries out the mathematical modeling and performance simulation to demonstrate its superiority in improving the network throughput at the cost of increasing antenna hardware costs.

  16. New photobiomodulation protocol prevents oral mucositis in hematopoietic stem cell transplantation recipients-a retrospective study.

    Science.gov (United States)

    Weissheimer, Camila; Curra, Marina; Gregianin, Lauro J; Daudt, Liane E; Wagner, Vivian P; Martins, Marco Antonio T; Martins, Manoela D

    2017-12-01

    Oral mucositis (OM) is an adverse side effect among hematopoietic stem cell transplantation (HSCT) recipients. The objective of this retrospective study was to evaluate the preventive effect of photobiomodulation (PBM) applied three times per week versus seven times per week in patients undergoing HSCT. The risk factors related to the incidence and severity of OM were also assessed. This was a retrospective study that evaluated 99 HSCT recipients who received different PBM protocols. Group I received three sessions per week, and group II received daily treatment. PBM was applied using a continuous-wave diode laser (InGaAlP; MM Optics, São Carlos, SP, Brazil) at a wavelength of 660 nm (visible-red) and a total radiant energy of 0.24 J per point. The baseline disease, type of transplant, type of conditioning, prophylaxis against graft-versus-host disease, OM grade, absolute leukocyte and platelet counts, and levels of liver and renal function markers were collected from medical records. The patients' age ranged from 13 to 71 years (mean/SD, 40.54 ± 16.45). No significant difference was observed between groups I and II regarding sex, age, ethnic, diagnosis, donor type, and conditioning treatment. Both PBM protocols were equally efficient in preventing OM (p = 0.34, ANOVA). Independent of the PBM protocol used, patients who received allogeneic transplant (p < 0.01-Fischer's exact test), total body irradiation (TBI-12Gy) (p = 0.01-chi-square test), busulfan + cyclophosphamide (p < 0.01-chi-square test), or methotrexate-containing regimens (p < 0.01-Fischer's exact test) demonstrated higher OM incidence and severity. Myelosuppression (p < 0.01-Mann-Whitney test) and impaired renal function (p = 0.02-Mann-Whitney test) were also considered risk factors for OM. Based on this retrospective data, PBM was effective in preventing OM in patients undergoing HSCT even when it was applied three times a week. A prospective study might be necessary to confirm

  17. Compliance with an empirical antimicrobial protocol improves the outcome of complicated intra-abdominal infections: a prospective observational study

    Science.gov (United States)

    Guilbart, M.; Zogheib, E.; Ntouba, A.; Rebibo, L.; Régimbeau, J. M.; Mahjoub, Y.; Dupont, H.

    2016-01-01

    Background Despite improvements in medical and surgical care, mortality attributed to complicated intra-abdominal infections (cIAI) remains high. Appropriate initial antimicrobial therapy (ABT) is key to successful management. The main causes of non-compliance with empirical protocols have not been clearly described. Methods An empirical ABT protocol was designed according to guidelines, validated in the institution and widely disseminated. All patients with cIAI (2009–2011) were then prospectively studied to evaluate compliance with this protocol and its impact on outcome. Patients were classified into two groups according to whether or not they received ABT in compliance with the protocol. Results 310 patients were included: 223 (71.9%) with community-acquired and 87 (28.1%) with healthcare-associated cIAI [mean age 60(17–97) yr, mean SAPS II score 24(16)]. Empirical ABT complied with the protocol in 52.3% of patients. The appropriateness of empirical ABT to target the bacteria isolated was 80%. Independent factors associated with non-compliance with the protocol were the anaesthetist's age ≥36 yr [OR 2.1; 95%CI (1.3–3.4)] and the presence of risk factors for multidrug-resistant bacteria (MDRB) [OR 5.4; 95%CI (3.0–9.5)]. Non-compliance with the protocol was associated with higher mortality (14.9 vs 5.6%, P=0.011) and morbidity: relaparotomy (P=0.047), haemodynamic failure (P=0.001), postoperative pneumonia (P=0.025), longer duration of mechanical ventilation (Pnon-compliance with the ABT protocol was independently associated with mortality [OR 2.4; 95% CI (1.1–5.7), P=0.04]. Conclusions Non-compliance with empirical ABT guidelines in cIAI is associated with increased morbidity and mortality. Information campaigns should target older anaesthetists and risk factors for MDRB. PMID:27317705

  18. Journal of Psychology in Africa: Submissions

    African Journals Online (AJOL)

    Author Guidelines. Please note that this journal is no longer published by NISC. Submission Preparation Checklist. As part of the submission process, authors are required to check off their submission's compliance with all of the following items, and submissions may be returned to authors that do not adhere to these ...

  19. Nationwide cross-sectional survey of schistosomiasis and soil-transmitted helminthiasis in Sudan: study protocol

    Directory of Open Access Journals (Sweden)

    Seungman Cha

    2017-09-01

    Full Text Available Abstract Background Schistosomiasis and soil-transmitted helminthiasis (STHs are target neglected tropical diseases (NTDs of preventive chemotherapy, but the control and elimination of these diseases have been impeded due to resource constraints. Few reports have described study protocol to draw on when conducting a nationwide survey. We present a detailed methodological description of the integrated mapping of schistosomiasis and STHs on the basis of our experiences, hoping that this protocol can be applied to future surveys in similar settings. In addition to determining the ecological zones requiring mass drug administration interventions, we aim to provide precise estimates of the prevalence of these diseases. Methods A school–based cross-sectional design will be applied for the nationwide survey across Sudan. The survey is designed to cover all districts in every state. We have divided each district into 3 different ecological zones depending on proximity to bodies of water. We will employ a probability-proportional-to-size sampling method for schools and systematic sampling for student selection to provide adequate data regarding the prevalence for schistosomiasis and STHs in Sudan at the state level. A total of 108,660 students will be selected from 1811 schools across Sudan. After the survey is completed, 391 ecological zones will be mapped out. To carry out the survey, 655 staff members were recruited. The feces and urine samples are microscopically examined by the Kato-Katz method and the sediment smears for helminth eggs respectively. For quality control, a minimum of 10% of the slides will be rechecked by the federal supervisors in each state and also 5% of the smears are validated again within one day by independent supervisors. Discussion This nationwide mapping is expected to generate important epidemiological information and indicators about schistosomiasis and STHs that will be useful for monitoring and evaluating the control

  20. Majority of systematic reviews published in high-impact journals neglected to register the protocols: a meta-epidemiological study.

    Science.gov (United States)

    Tsujimoto, Yasushi; Tsujimoto, Hiraku; Kataoka, Yuki; Kimachi, Miho; Shimizu, Sayaka; Ikenoue, Tatsuyoshi; Fukuma, Shingo; Yamamoto, Yosuke; Fukuhara, Shunichi

    2017-04-01

    To describe the registration of systematic review (SR) protocols and examine whether or not registration reduced the outcome reporting bias in high-impact journals. We searched MEDLINE via PubMed to identify SRs of randomized controlled trials of interventions. We included SRs published between August 2009 and June 2015 in the 10 general and internal medicinal journals with the highest impact factors in 2013. We examined the proportion of SR protocol registration and investigated the relationship between registration and outcome reporting bias using multivariable logistic regression. Among the 284 included reviews, 60 (21%) protocols were registered. The proportion of registration increased from 5.6% in 2009 to 27% in 2015 (P for trend review and Meta-Analysis (PRISMA) adherence and protocol registration was not statistically significant (OR 1.09, 95% CI 0.59-2.01). Six years after the launch of the PRISMA statement, the proportion of protocol registration in high-impact journals has increased some but remains low. The present study found no evidence suggesting that protocol registration reduced outcome reporting bias. Copyright © 2017 Elsevier Inc. All rights reserved.

  1. Hindrance of conservation biology by delays in the submission of manuscripts.

    Science.gov (United States)

    O'Donnell, Ryan P; Supp, Sarah R; Cobbold, Stephanie M

    2010-04-01

    Timely dissemination of scientific findings depends not only on rapid publication of submitted manuscripts, a topic which has received much discussion, but also on rapid submission of research after the research is completed. We measured submission delay (time from the last date of data collection to the submission of a manuscript) for every paper from 14 journals in 2007 and compared these submission delays among four fields of biology (conservation, taxonomy, behavior, and evolution). Manuscripts published in leading journals in the field of conservation biology have the longest delays in publication of accepted manuscripts and the longest intervals between completion of research and submission of the manuscript. Delay in manuscript submission accounts for more than half of the total time from last date of data collection to publication. Across fields, the number of authors was significantly negatively correlated with submission delay, but conservation journals had the second highest number of authors and the greatest submission delay, so submission of conservation manuscripts was not hindered by a shortage of collaboration relative to other fields. Rejection rates were greater in conservation journals than in behavior and evolution, but rejection times were faster; thus, there were no obvious net differences among fields in the time papers spent waiting to be rejected. Publication delay has been reduced significantly in the last 7 years, but was still greater in conservation journals than in any of the other three fields we studied. Thus, the urgent field of conservation biology is hindered in both preparation and publication of manuscripts.

  2. Imaging findings in cardiac masses (Part I): study protocol and benign tumors.

    Science.gov (United States)

    Díaz Angulo, C; Méndez Díaz, C; Rodríguez García, E; Soler Fernández, R; Rois Siso, A; Marini Díaz, M

    2015-01-01

    Cardiac masses represent a diagnostic challenge because decisions about treatment are based on imaging techniques. Echocardiography, magnetic resonance (MR) and computed tomography (CT) are fundamental for the detection, characterization, and staging of cardiac masses as well as for planning their treatment. Most primary cardiac tumors are benign; myxomas, papillary fibroelastomas, and lipomas are the most common. The location of the tumors and its characteristics on CT and MR orient the etiologic diagnosis in most cases. This article describes the protocols for CT and MR studies of cardiac masses as well as the morphologic findings, predominant locations, and most useful characteristics for characterizing benign cardiac masses and establishing the differential diagnosis with malignant cardiac tumors and non-neoplastic pseudotumors. Copyright © 2014 SERAM. Published by Elsevier España, S.L.U. All rights reserved.

  3. Study protocol; Thyroid hormone Replacement for Untreated older adults with Subclinical hypothyroidism

    DEFF Research Database (Denmark)

    Stott, David J.; Gussekloo, Jacobijn; Kearney, Patricia M.

    2017-01-01

    BACKGROUND: Subclinical hypothyroidism (SCH) is a common condition in elderly people, defined as elevated serum thyroid-stimulating hormone (TSH) with normal circulating free thyroxine (fT4). Evidence is lacking about the effect of thyroid hormone treatment. We describe the protocol of a large...... in the placebo group. The primary outcomes are changes in two domains (hypothyroid symptoms and fatigue / vitality) on the thyroid-related quality of life questionnaire (ThyPRO) at one year. The study has 80% power (at p = 0.025, 2-tailed) to detect a change with levothyroxine treatment of 3.......0% on the hypothyroid scale and 4.1% on the fatigue / vitality scale with a total target sample size of 750 patients. Secondary outcomes include general health-related quality of life (EuroQol), fatal and non-fatal cardiovascular events, handgrip strength, executive cognitive function (Letter Digit Coding Test), basic...

  4. Optimal protocol for teleconsultation with a cellular phone for dentoalveolar trauma: an in-vitro study

    Energy Technology Data Exchange (ETDEWEB)

    Park, Won Se; Lee, Hae Na; Jeong, Jin Sun; Kwon, Jung Hoon; Lee, Grace H; Kim, Kee Dong [College of Dentistry, Yonsei University, Seoul (Korea, Republic of)

    2012-06-15

    Dental trauma is frequently unpredictable. The initial assessment and urgent treatment are essential for dentists to save the patient's teeth. Mobile-phone-assisted teleconsultation and telediagnosis for dental trauma could be an aid when a dentist is not available. In the present in-vitro study, we evaluated the success rate and time to transfer images under various conditions. We analyzed the image quality of cameras built into mobile phones based on their resolution, autofocus, white-balance, and anti-movement functions. The image quality of most built-in cameras was acceptable to perform the initial assessment, with the autofocus function being essential to obtain high-quality images. The transmission failure rate increased markedly when the image size exceeded 500 kB and the additional text messaging did not improve the success rate or the transmission time. Our optimal protocol could be useful for emergency programs running on the mobile phones.

  5. Twelve tips for conducting a postgraduate course on study design and study protocol writing for the medical profession.

    Science.gov (United States)

    Ljung, Rickard; Jansson, Catarina; Nordenstedt, Helena; Martin, Lena; Lagergren, Pernilla; Lagergren, Jesper

    2012-01-01

    It is desirable to use a methodological approach of the highest scientific quality when planning and conducting valid research. However, several studies have shown that the biostatistical and epidemiological knowledge of academically active health care professionals is far below the desired level. To outline an approach to conducting a postgraduate course in clinical study design and study protocol writing. We offer 12 tips based on critical reflection of our experience of conducting and continuously improving a course in study design repeatedly over several years, combined with evidence from the literature on pedagogical approaches. The tips are organized in chronological order so that a course director will be able to develop a similar course. Combining the results of our critical reflection with evidence from the literature has allowed us to develop a successful approach to running courses in study design and study protocol writing. We hope that our extensive experience in conducting this course, as reflected by the 12 tips, will support and inspire others planning similar courses.

  6. Interreality for the management and training of psychological stress: study protocol for a randomized controlled trial

    Science.gov (United States)

    2013-01-01

    Background Psychological stress occurs when an individual perceives that environmental demands tax or exceed his or her adaptive capacity. Its association with severe health and emotional diseases, points out the necessity to find new efficient strategies to treat it. Moreover, psychological stress is a very personal problem and requires training focused on the specific needs of individuals. To overcome the above limitations, the INTERSTRESS project suggests the adoption of a new paradigm for e-health - Interreality - that integrates contextualized assessment and treatment within a hybrid environment, bridging the physical and the virtual worlds. According to this premise, the aim of this study is to investigate the advantages of using advanced technologies, in combination with cognitive behavioral therapy (CBT), based on a protocol for reducing psychological stress. Methods/Design The study is designed as a randomized controlled trial. It includes three groups of approximately 50 subjects each who suffer from psychological stress: (1) the experimental group, (2) the control group, (3) the waiting list group. Participants included in the experimental group will receive a treatment based on cognitive behavioral techniques combined with virtual reality, biofeedback and mobile phone, while the control group will receive traditional stress management CBT-based training, without the use of new technologies. The wait-list group will be reassessed and compared with the two other groups five weeks after the initial evaluation. After the reassessment, the wait-list patients will randomly receive one of the two other treatments. Psychometric and physiological outcomes will serve as quantitative dependent variables, while subjective reports of participants will be used as the qualitative dependent variable. Discussion What we would like to show with the present trial is that bridging virtual experiences, used to learn coping skills and emotional regulation, with real

  7. [An integrative and transdiagnostic relaxation protocol for anxious patients. Results of a pilot study].

    Science.gov (United States)

    Servant, D; Germe, A; Autuori, M; De Almeida, F; Hay, M; Douilliez, C; Vaiva, G

    2014-12-01

    The literature data show that relaxation practice is effective in reducing anxiety symptoms. Different techniques such as progressive muscular relaxation, autogenic training, applied relaxation and meditation have been evaluated independently for anxiety disorders. The question is to know whether the combination of various techniques may be of interest in the transdiagnostic treatment of anxiety disorders. The present study assessed the short-term efficacy of a 10-week integrative and transdiagnostic relaxation program for anxiety disorders in outpatients of an anxiety disorders unit. The diagnoses were made according to the Mini-International Neuropsychiatric Interview (MINI; Sheehan et al., 1998) and completed with an assessment of anxiety and depressive symptoms using: the State Trait Anxiety Inventory (STAI-Y, -S and -T), the Penn State Worry Questionnaire (PSWQ) and the Beck Depression Inventory (BDI-II). Four techniques were integrated into the structured 10-week protocol: breathing control, muscular relaxation, meditation and mental visualization. Twenty-eight patients (12 men and 16 women), mean age (S.D.)=38.82 years (11.57), were included in the study. All the included patients fulfilled the DSM-IV criteria for a current diagnosis of Generalized Anxiety Disorder (n=13) or Panic Disorder (n=15) with or without agoraphobia. At the end of the 10 sessions, we found a significant reduction in mean scores (S.D.) on the STAI-T from 53.179 (6.037) to 49.821 (8.028) (Panxiety, depression and worry. The integrative and transdiagnostic relaxation program could represent an accessible and effective treatment to reduce anxious and depressive symptoms in various anxiety disorders. Future research should address the development of controlled trials assessing the impact of the different dimensions of anxiety and the long-term effects of this protocol. Copyright © 2014 L’Encéphale, Paris. Published by Elsevier Masson SAS. All rights reserved.

  8. Interreality for the management and training of psychological stress: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Pallavicini, Federica; Gaggioli, Andrea; Raspelli, Simona; Cipresso, Pietro; Serino, Silvia; Vigna, Cinzia; Grassi, Alessandra; Morganti, Luca; Baruffi, Margherita; Wiederhold, Brenda; Riva, Giuseppe

    2013-06-28

    Psychological stress occurs when an individual perceives that environmental demands tax or exceed his or her adaptive capacity. Its association with severe health and emotional diseases, points out the necessity to find new efficient strategies to treat it. Moreover, psychological stress is a very personal problem and requires training focused on the specific needs of individuals. To overcome the above limitations, the INTERSTRESS project suggests the adoption of a new paradigm for e-health--Interreality--that integrates contextualized assessment and treatment within a hybrid environment, bridging the physical and the virtual worlds. According to this premise, the aim of this study is to investigate the advantages of using advanced technologies, in combination with cognitive behavioral therapy (CBT), based on a protocol for reducing psychological stress. The study is designed as a randomized controlled trial. It includes three groups of approximately 50 subjects each who suffer from psychological stress: (1) the experimental group, (2) the control group, (3) the waiting list group. Participants included in the experimental group will receive a treatment based on cognitive behavioral techniques combined with virtual reality, biofeedback and mobile phone, while the control group will receive traditional stress management CBT-based training, without the use of new technologies. The wait-list group will be reassessed and compared with the two other groups five weeks after the initial evaluation. After the reassessment, the wait-list patients will randomly receive one of the two other treatments. Psychometric and physiological outcomes will serve as quantitative dependent variables, while subjective reports of participants will be used as the qualitative dependent variable. What we would like to show with the present trial is that bridging virtual experiences, used to learn coping skills and emotional regulation, with real experiences using advanced technologies

  9. Efficacy of smoking prevention program 'Smoke-free Kids': study protocol of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    van Schayck Onno CP

    2009-12-01

    Full Text Available Abstract Background A strong increase in smoking is noted especially among adolescents. In the Netherlands, about 5% of all 10-year olds, 25% of all 13-year olds and 62% of all 17-year olds report ever smoking. In the U.S., an intervention program called 'Smoke-free Kids' was developed to prevent children from smoking. The present study aims to assess the effects of this home-based smoking prevention program in the Netherlands. Methods/Design A randomized controlled trial is conducted among 9 to 11-year old children of primary schools. Participants are randomly assigned to the intervention and control conditions. The intervention program consists of five printed activity modules designed to improve parenting skills specific to smoking prevention and parent-child communication regarding smoking. These modules will include additional sheets with communication tips. The modules for the control condition will include solely information on smoking and tobacco use. Initiation of cigarette smoking (first instance of puffing on a lighted cigarette, susceptibility to cigarette smoking, smoking-related cognitions, and anti-smoking socialization will be the outcome measures. To collect the data, telephone interviews with mothers as well as with their child will be conducted at baseline. Only the children will be examined at post-intervention follow-ups (6, 12, 24, and 36 months after the baseline. Discussion This study protocol describes the design of a randomized controlled trial that will evaluate the effectiveness of a home-based smoking prevention program. We expect that a significantly lower number of children will start smoking in the intervention condition compared to control condition as a direct result of this intervention. If the program is effective, it is applicable in daily live, which will facilitate implementation of the prevention protocol. Trial registration Netherlands Trial Register NTR1465

  10. Development and Pilot Study of a Welfare Assessment Protocol for Dairy Calves

    NARCIS (Netherlands)

    Barry, John Patrick; Kennedy, E.; Boer, de I.J.M.; Bokkers, E.A.M.

    2017-01-01

    As agricultural systems continue to develop and become more refined, so too must protocols used to assess the welfare of animals experiencing them. The aim of this research was to develop a welfare assessment protocol for pre-weaned dairy calves (<12 weeks old),and investigate, and improve, its

  11. Risk of bias and confounding of observational studies of Zika virus infection: A scoping review of research protocols.

    Directory of Open Access Journals (Sweden)

    Ludovic Reveiz

    Full Text Available Given the severity and impact of the current Zika virus (ZIKV outbreak in the Americas, numerous countries have rushed to develop research studies to assess ZIKV and its potential health consequences. In an effort to ensure that studies are comprehensive, both internally and externally valid, and with reliable results, the World Health Organization, the Pan American Health Organization, Institut Pasteur, the networks of Fiocruz, the Consortia for the Standardization of Influenza Seroepidemiology (CONSISE and the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC have generated six standardized clinical and epidemiological research protocols and questionnaires to address key public health questions on ZIKV.We conducted a systematic search of ongoing study protocols related to ZIKV research. We analyzed the content of protocols of 32 cohort studies and 13 case control studies for systematic bias that could produce erroneous results. Additionally we aimed to characterize the risks of bias and confounding in observational studies related to ZIKV and to propose ways to minimize them, including the use of six newly standardized research protocols.Observational studies of ZIKV face an array of challenges, including measurement of exposure and outcomes (microcephaly and Guillain-Barré Syndrome. Potential confounders need to be measured where known and controlled for in the analysis. Selection bias due to non-random selection is a significant issue, particularly in the case-control design, and losses to follow-up is equally important for the cohort design.Observational research seeking to answer key questions on the ZIKV should consider these restrictions and take precautions to minimize bias in an effort to provide reliable and valid results. Utilization of the standardized research protocols developed by the WHO, PAHO, Institut Pasteur, and CONSISE will harmonize the key methodological aspects of each study design to

  12. Risk of bias and confounding of observational studies of Zika virus infection: A scoping review of research protocols.

    Science.gov (United States)

    Reveiz, Ludovic; Haby, Michelle M; Martínez-Vega, Ruth; Pinzón-Flores, Carlos E; Elias, Vanessa; Smith, Emma; Pinart, Mariona; Broutet, Nathalie; Becerra-Posada, Francisco; Aldighieri, Sylvain; Van Kerkhove, Maria D

    2017-01-01

    Given the severity and impact of the current Zika virus (ZIKV) outbreak in the Americas, numerous countries have rushed to develop research studies to assess ZIKV and its potential health consequences. In an effort to ensure that studies are comprehensive, both internally and externally valid, and with reliable results, the World Health Organization, the Pan American Health Organization, Institut Pasteur, the networks of Fiocruz, the Consortia for the Standardization of Influenza Seroepidemiology (CONSISE) and the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC) have generated six standardized clinical and epidemiological research protocols and questionnaires to address key public health questions on ZIKV. We conducted a systematic search of ongoing study protocols related to ZIKV research. We analyzed the content of protocols of 32 cohort studies and 13 case control studies for systematic bias that could produce erroneous results. Additionally we aimed to characterize the risks of bias and confounding in observational studies related to ZIKV and to propose ways to minimize them, including the use of six newly standardized research protocols. Observational studies of ZIKV face an array of challenges, including measurement of exposure and outcomes (microcephaly and Guillain-Barré Syndrome). Potential confounders need to be measured where known and controlled for in the analysis. Selection bias due to non-random selection is a significant issue, particularly in the case-control design, and losses to follow-up is equally important for the cohort design. Observational research seeking to answer key questions on the ZIKV should consider these restrictions and take precautions to minimize bias in an effort to provide reliable and valid results. Utilization of the standardized research protocols developed by the WHO, PAHO, Institut Pasteur, and CONSISE will harmonize the key methodological aspects of each study design to minimize bias at

  13. 76 FR 64357 - Submission for OMB Review; Comment Request; The Hispanic Community Health Study (HCHS)/Study of...

    Science.gov (United States)

    2011-10-18

    ...)/Study of Latinos (SOL) will identify risk factors for cardiovascular and lung disease in Hispanic populations and determine the role of acculturation in the prevalence and development of these diseases... Chicago, Miami, San Diego, and the Bronx. The study will examine measures of obesity, physical activity...

  14. Causes and consequences of cerebral small vessel disease. The RUN DMC study: a prospective cohort study. Study rationale and protocol

    Directory of Open Access Journals (Sweden)

    van der Vlugt Maureen J

    2011-02-01

    Full Text Available Abstract Background Cerebral small vessel disease (SVD is a frequent finding on CT and MRI scans of elderly people and is related to vascular risk factors and cognitive and motor impairment, ultimately leading to dementia or parkinsonism in some. In general, the relations are weak, and not all subjects with SVD become demented or get parkinsonism. This might be explained by the diversity of underlying pathology of both white matter lesions (WML and the normal appearing white matter (NAWM. Both cannot be properly appreciated with conventional MRI. Diffusion tensor imaging (DTI provides alternative information on microstructural white matter integrity. The association between SVD, its microstructural integrity, and incident dementia and parkinsonism has never been investigated. Methods/Design The RUN DMC study is a prospective cohort study on the risk factors and cognitive and motor consequences of brain changes among 503 non-demented elderly, aged between 50-85 years, with cerebral SVD. First follow up is being prepared for July 2011. Participants alive will be included and invited to the research centre to undergo a structured questionnaire on demographics and vascular risk factors, and a cognitive, and motor, assessment, followed by a MRI protocol including conventional MRI, DTI and resting state fMRI. Discussion The follow up of the RUN DMC study has the potential to further unravel the causes and possibly better predict the consequences of changes in white matter integrity in elderly with SVD by using relatively new imaging techniques. When proven, these changes might function as a surrogate endpoint for cognitive and motor function in future therapeutic trials. Our data could furthermore provide a better understanding of the pathophysiology of cognitive and motor disturbances in elderly with SVD. The execution and completion of the follow up of our study might ultimately unravel the role of SVD on the microstructural integrity of the white

  15. Investigation of the Effect of Sport on Submissive Behavior and Communication Skills of High School Students

    Science.gov (United States)

    Abakay, Ugur

    2013-01-01

    This study was carried out to detect the differences in submissive behaviors and communication skills of high school students in terms of sports activities and relationship between communication skills and properties of submissive behavior of high school students who are actively involved in sports activities. In this respect at the study, 728…

  16. Study of effective dose of various protocols in equipment cone beam CT

    Energy Technology Data Exchange (ETDEWEB)

    Soares, M. R.; Maia, A. F. [Universidade Federale de Sergipe, Departamento de Fisica, Cidade Universitaria Prof. Jose Aloisio de Campos, Marechal Rondon s/n, Jardim Rosa Elze, 49-100000 Sao Cristovao, Sergipe (Brazil); Batista, W. O. [Instituto Federal da Bahia, Rua Emidio dos Santos s/n, Barbalho, Salvador, 40301015 Bahia (Brazil); Caldas, L. V. E.; Lara, P. A., E-mail: mrs2206@gmail.com [Instituto de Pesquisas Energeticas e Nucleares / CNEN, Av. Lineu Prestes 2242, Cidade Universitaria, 05508-000 Sao Paulo (Brazil)

    2014-08-15

    Currently the cone beam computed tomography is widely used in various procedures of dental radiology. Although the doses values associated with the procedures of cone beam CT are low compared to typical values associated with dental radiology procedure in multi slices CT. However can be high compared to typical values of other techniques commonly used in dental radiology. The present scenario is a very wide range of designs of equipment and, consequently, lack of uniformity in all parameters associated with x-ray generation and geometry. In this context, this study aimed to evaluate and calculate the absorbed dose in organs and tissues relevant and estimate effective dose for different protocols with different geometries of exposure in five cone beam CT equipment. For this, a female Alderson anthropomorphic phantom, manufactured by Radiology Support Devices was used. The phantom was irradiated with 26 dosimeters LiF: Mg, Ti (TLD-100), inserted in organs and tissues along the layers forming the head and neck of the phantom. The equipment used, in this present assessment, was: i-CAT Classical, Kodak 9000 3D, Gendex GXCB 500, Sirona Orthophos X G 3D and Planmeca Pro Max 3D. The effective doses were be determined by the ICRP 103 weighting factors. The values were between 7.0 and 111.5 micro Sv, confirming the broad dose range expected due to the diversity of equipment and protocols used in each equipment. The values of effective dose per Fov size were: between 7 and 51.2 micro Sv for located Fov; between 17.6 and 52.0 micro Sv for medium Fov; and between 11.5 and 43.1 micro Sv to large Fov (maxillofacial). In obtaining the effective dose the measurements highlighted a relevance contribution of dose absorbed by the remaining organs (36%), Salivary glands (30%), thyroid (12%) and bone marrow (12%). (Author)

  17. Longitudinal designs to study neighbourhood effects on the development of obesity: a scoping review protocol.

    Science.gov (United States)

    Letarte, Laurence; Lebel, Alexandre; Waygood, E O D; Tchernof, André; Biertho, Laurent

    2018-01-24

    The prevalence of obesity has increased significantly in the last three decades and became an important public health concern. Evidence of weight status variability at the neighbourhood level has led researchers to look more precisely at the characteristics of local geographic areas that might influence energy balance related behaviours, giving rise to the field of the 'neighbourhood effect' in public health research. Among an abundant literature about neighbourhood effects and obesity, we propose a protocol for a scoping review that will aim at determining how temporal measurements of residential neighbourhood exposure, individual covariates and weight outcome are integrated in longitudinal designs. A list of relevant citations will be obtained through a comprehensive systematic database search in Pubmed, Web of Science and Embase. The search strategy will be designed using a broad definition of neighbourhood to take into account the heterogeneity of this concept in research. Two investigators will screen titles, abstracts and entire publications using predetermined eligibility criteria yielding a list of selected publications. Data from the publications included in the scoping review will be charted according to bibliographic information, study population, exposure, outcomes and results. To our knowledge, our protocol will yield the first scoping review regarding longitudinal designs of neighbourhood effect on obesity. Describing how longitudinal designs include temporal measurements of exposure, covariates and outcome is a necessary step in the quest to determine if or which contextual characteristics are likely to be involved in the development of obesity. Such information would bring new knowledge to complement current aetiological investigations and would contribute to enhancing resource allocation strategies for stakeholders in developing relevant interventions to prevent obesity and its negative impacts. © Article author(s) (or their employer(s) unless

  18. Long-term anesthetic protocol in rats: feasibility in electrophysiology studies in visual prosthesis.

    Science.gov (United States)

    Barriga-Rivera, Alejandro; Tatarinoff, Veronica; Lovell, Nigel H; Morley, John W; Suaning, Gregg J

    2017-11-17

    Electrical stimulation of excitable cells provides therapeutic benefits for a variety of medical conditions, including restoration of partial vision to those blinded via some types of retinal degeneration. To improve visual percepts elicited by the current technology, researchers are conducting acute electrophysiology experiments, mainly in cats. However, the rat can provide a model of a range of retinal diseases and possesses a sufficiently large eye to be used in this field. This article presents a long-term anesthetic protocol to enable electrophysiology experiments to further the development of visual prostheses. Six Long-Evans rats (aged between 14 and 16 weeks) were included in this study. Surgical anesthesia was maintained for more than 15 h by combining constant intravenous infusion of ketamine (24.0-34.5 mg/kg/h), xylazine (0.9-1.2 mg/kg/h), and inhaled isoflurane in oxygen (<0.5%). Overall heart rate, respiratory rate, and body temperature remained between 187-233 beats/min, 45-58 breaths/min, and 36-38 °C, respectively. Neural responses to 200-ms light pulses were recorded from the superior colliculus using a 32-channel neural probe at the beginning and before termination of the experiment. Robust responses were recorded from distinct functional types of retinal pathways. In addition, a platinum electrode was implanted in the retrobulbar space. The retina was electrically stimulated, and the activation threshold was determined to be 5.24 ± 0.24 μC/cm2 . This protocol may be used not only in the field of visual prosthesis research, but in other research areas requiring longer term acute experiments. © 2017 American College of Veterinary Ophthalmologists.

  19. 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.

  20. Timed Analysis of Security Protocols

    NARCIS (Netherlands)

    Corin, R.J.; Etalle, Sandro; Hartel, Pieter H.; Mader, Angelika H.

    We propose a method for engineering security protocols that are aware of timing aspects. We study a simplified version of the well-known Needham Schroeder protocol and the complete Yahalom protocol, where timing information allows the study of different attack scenarios. We model check the protocols

  1. Timed Analysis of Security Protocols

    NARCIS (Netherlands)

    Corin, R.J.; Etalle, Sandro; Hartel, Pieter H.; Mader, Angelika H.

    2007-01-01

    We propose a method for engineering security protocols that are aware of timing aspects. We study a simplified version of the well-known Needham Schroeder protocol and the complete Yahalom protocol, where timing information allows the study of different attack scenarios. We model check the protocols

  2. How to design in situ studies: an evaluation of experimental protocols

    Directory of Open Access Journals (Sweden)

    Young-Hye Sung

    2014-08-01

    Full Text Available Objectives Designing in situ models for caries research is a demanding procedure, as both clinical and laboratory parameters need to be incorporated in a single study. This study aimed to construct an informative guideline for planning in situ models relevant to preexisting caries studies. Materials and Methods An electronic literature search of the PubMed database was performed. A total 191 of full articles written in English were included and data were extracted from materials and methods. Multiple variables were analyzed in relation to the publication types, participant characteristics, specimen and appliance factors, and other conditions. Frequencies and percentages were displayed to summarize the data and the Pearson's chi-square test was used to assess a statistical significance (p < 0.05. Results There were many parameters commonly included in the majority of in situ models such as inclusion criteria, sample sizes, sample allocation methods, tooth types, intraoral appliance types, sterilization methods, study periods, outcome measures, experimental interventions, etc. Interrelationships existed between the main research topics and some parameters (outcome measures and sample allocation methods among the evaluated articles. Conclusions It will be possible to establish standardized in situ protocols according to the research topics. Furthermore, data collaboration from comparable studies would be enhanced by homogeneous study designs.

  3. A comparative study of bone densitometry during osseointegration: piezoelectric surgery versus rotary protocols.

    Science.gov (United States)

    Di Alberti, Luca; Donnini, Federica; Di Alberti, Claudio; Camerino, Michele

    2010-09-01

    To date, there have been no studies on the outcome of osseointegration of alveolar bone around dental implants inserted with piezoelectric osteotomy versus conventional osteotomy. The aim of this study was to compare the radiographic differences, through evaluation of peri-implant bone density, between implant insertion using traditional surgical technique and piezoelectric technique. Forty patients were selected whose treatment consisted of a minimum of two implants placed in nonpathologic native bone. A single type of implant surface (SLA) was chosen. The implants were placed following the manufacturer protocol for traditional surgical technique and piezoelectric technique. Radiographs were taken following surgery and 30, 60, and 90 days after surgery. The bone density was studied with the densitometry application. All patients completed the study period with success. Despite a limited number of treated patients, the results of this pilot study demonstrated that (1) piezoelectric implant site preparation promotes better bone density and osteogenesis, and (2) the piezoelectric technique is predictable, with a 100% success rate in this study.

  4. Change to costs and lengths of stay in the emergency department and the Brisbane protocol: an observational study.

    Science.gov (United States)

    Cheng, Qinglu; Greenslade, Jaimi H; Parsonage, William A; Barnett, Adrian G; Merollini, Katharina; Graves, Nicholas; Peacock, W Frank; Cullen, Louise

    2016-02-25

    To compare health service cost and length of stay between a traditional and an accelerated diagnostic approach to assess acute coronary syndromes (ACS) among patients who presented to the emergency department (ED) of a large tertiary hospital in Australia. This historically controlled study analysed data collected from two independent patient cohorts presenting to the ED with potential ACS. The first cohort of 938 patients was recruited in 2008-2010, and these patients were assessed using the traditional diagnostic approach detailed in the national guideline. The second cohort of 921 patients was recruited in 2011-2013 and was assessed with the accelerated diagnostic approach named the Brisbane protocol. The Brisbane protocol applied early serial troponin testing for patients at 0 and 2 h after presentation to ED, in comparison with 0 and 6 h testing in traditional assessment process. The Brisbane protocol also defined a low-risk group of patients in whom no objective testing was performed. A decision tree model was used to compare the expected cost and length of stay in hospital between two approaches. Probabilistic sensitivity analysis was used to account for model uncertainty. Compared with the traditional diagnostic approach, the Brisbane protocol was associated with reduced expected cost of $1229 (95% CI -$1266 to $5122) and reduced expected length of stay of 26 h (95% CI -14 to 136 h). The Brisbane protocol allowed physicians to discharge a higher proportion of low-risk and intermediate-risk patients from ED within 4 h (72% vs 51%). Results from sensitivity analysis suggested the Brisbane protocol had a high chance of being cost-saving and time-saving. This study provides some evidence of cost savings from a decision to adopt the Brisbane protocol. Benefits would arise for the hospital and for patients and their families. 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/

  5. Evaluation of an intensive insulin transition protocol in the intensive care unit setting: a before and after study

    Directory of Open Access Journals (Sweden)

    Jacobson LA

    2012-03-01

    Full Text Available The benefits of controlling blood glucose levels in intensive care units (ICUs are well documented.Objective: This study determined the effectiveness and safety of a standardized transition order set for converting a continuous insulin infusion to a subcutaneous insulin regimen in non-cardiovascular surgery ICUs patient population.Methods: A retrospective study was conducted. Patients presenting with diabetic ketoacidosis or hyperosmolar hyperglycemic syndrome were excluded. One hundred patients were included prior to and 100 patients were included after initiating the transition order set. Blood glucose control was reviewed for up to 72 hours following the transition.Results: A total of 115 patients were included in data analysis: 85 prior to and 30 after transition protocol. All patients transitioned using the protocol were transitioned to basal insulin, compared to only 40% of the prior to protocol group. Patients transitioned correctly per the transition order set, “per protocol,” had 54% of blood sugars within the desired range, no increase in hypoglycemic events, and on average 5.56 hyperglycemic events (blood glucose >180 mg/dL per person during the 72 hours compared to 6.68 and 9.00 for the prior to protocol group and the “off protocol” group (transitioned different than the protocol recommended, respectively (p= 0.05. There were significant differences in blood sugar control at 48 and 72 hours between the “per protocol” and “off protocol” groups (p= 0.01 and a 40% reduction in sliding scale or correctional insulin coverage.Conclusion: The addition of basal insulin to transition regimens resulted in fewer hyperglycemic events with no increase in hypoglycemic events. Patients transitioned “per protocol” had better glucose control demonstrated by: less hyperglycemic events, lower mean blood glucose levels at 48 and 72 hours, and lower need for correctional insulin. These findings showed benefits of glycemic control in

  6. Controlled ovarian stimulation using a long gonadotropin-releasing hormone antagonist protocol: a proof of concept and feasibility study.

    Science.gov (United States)

    Weissman, Ariel; Ravhon, Amir; Steinfeld, Zohar; Nahum, Hana; Golan, Abraham; Levran, David

    2013-01-01

    To evaluate the feasibility of a long protocol of controlled ovarian stimulation prior to in vitro fertilization (IVF) and embryo transfer with a gonadotropin-releasing hormone (GnRH) antagonist used for pituitary and ovarian suppression. Thirty patients undergoing IVF/intracytoplasmic sperm injection were randomized into two groups. The control group (n = 16) received a standard flexible GnRH antagonist protocol. Ovarian stimulation consisted of 225 IU/day of recombinant follicle-stimulating hormone for 5 days, followed by 225 IU/day of human menopausal gonadotropin until human chorionic gonadotropin (hCG) administration. The study group (n = 14) received 0.25 mg of GnRH antagonist daily for 7 days, thereafter, upon confirmation of pituitary and ovarian suppression, ovarian stimulation was commenced with the same protocol as used in the control group. Hormone and follicle dynamics, as well as laboratory characteristics and cycle outcome, were compared for both groups. Both groups were comparable in baseline characteristics. Pituitary and ovarian suppression were effectively achieved in 12/14 patients in the study group. The duration of ovarian stimulation and gonadotropin consumption were similar in both groups, as was also the number and size of follicles on hCG day. The results of our study confirm the feasibility of a long GnRH antagonist protocol. This regimen could become another option to optimize GnRH antagonist protocols, and should thus be further explored. © 2013 S. Karger AG, Basel.

  7. Parental intimate partner homicide and its consequences for children: protocol for a population-based study.

    Science.gov (United States)

    Alisic, Eva; Groot, Arend; Snetselaar, Hanneke; Stroeken, Tielke; van de Putte, Elise

    2015-07-29

    The loss of a parent due to intimate partner homicide has a major impact on children. Professionals involved have to make far-reaching decisions regarding placement, guardianship, mental health care and contact with the perpetrating parent, without an evidence base to guide these decisions. We introduce a study protocol to a) systematically describe the demographics, circumstances, mental health and wellbeing of children bereaved by intimate partner homicide and b) build a predictive model of factors associated with children's mental health and wellbeing after intimate partner homicide. This study focuses on children bereaved by parental intimate partner homicide in the Netherlands over a period of 20 years (1993 - 2012). It involves an incidence study to identify all Dutch intimate partner homicide cases between 1993 and 2012 by which children have been bereaved; systematic case reviews to describe the demographics, circumstances and care trajectories of these children; and a mixed-methods study to assess mental health, wellbeing, and experiences regarding decisions made and care provided. Clinical experience and initial research suggest that the children involved often need long-term intensive mental health and case management. The costs of these services are extensive and the stakes are high. This study lays the foundation for an international dataset and evidence-informed decision making.

  8. Bioremediation protocols

    National Research Council Canada - National Science Library

    Sheehan, David

    1997-01-01

    ..., .. . . . . .. ,. . . .. . . . . . . . .. . . . . .. . . .. . .. 3 2 Granular Nina Sludge Christiansen, Consortia lndra for Bioremediation, M. Mathrani, and Birgitte K. Ahring . 23 PART II PROTOCOLS...

  9. Short and long-term effectiveness of couple counselling: a study protocol

    Directory of Open Access Journals (Sweden)

    Schofield Margot J

    2012-09-01

    Full Text Available Abstract Background Healthy couple relationships are fundamental to a healthy society, whereas relationship breakdown and discord are linked to a wide range of negative health and wellbeing outcomes. Two types of relationship services (couple counselling and relationship education have demonstrated efficacy in many controlled studies but evidence of the effectiveness of community-based relationship services has lagged behind. This study protocol describes an effectiveness evaluation of the two types of community-based relationship services. The aims of the Evaluation of Couple Counselling study are to: map the profiles of clients seeking agency-based couple counselling and relationship enhancement programs in terms of socio-demographic, relationship, health, and health service use indicators; to determine 3 and 12-month outcomes for relationship satisfaction, commitment, and depression; and determine relative contributions of client and therapy factors to outcomes. Methods/Design A quasi-experimental pre-post-post evaluation design is used to assess outcomes for couples presenting for the two types of community-based relationship services. The longitudinal design involves a pre-treatment survey and two follow-up surveys at 3- and 12-months post-intervention. The study is set in eight Relationships Australia Victoria centres, across metropolitan, outer suburbs, and regional/rural sites. Relationships Australia, a non-government organisation, is the largest provider of couple counselling and relationship services in Australia. The key outcomes are couple satisfaction, relationship commitment, and depression measured by the CESD-10. Multi-level modelling will be used to account for the dyadic nature of couple data. Discussion The study protocol describes the first large scale investigation of the effectiveness of two types of relationship services to be conducted in Australia. Its significance lies in providing more detailed profiles of couples who

  10. An Empirical Study and some Improvements of the MiniMac Protocol for Secure Computation

    DEFF Research Database (Denmark)

    Damgård, Ivan Bjerre; Lauritsen, Rasmus; Toft, Tomas

    2014-01-01

    Recent developments in Multi-party Computation (MPC) has resulted in very efficient protocols for dishonest majority in the preprocessing model. In particular, two very promising protocols for Boolean circuits have been proposed by Nielsen et al. (nicknamed TinyOT) and by Damg˚ard and Zakarias...... (nicknamed MiniMac). While TinyOT has already been implemented, we present in this paper the first implementation of MiniMac, using the same platform as the existing TinyOT implementation. We also suggest several improvements of MiniMac, both on the protocol design and implementation level. In particular, we...

  11. Wayfinding in ageing and Alzheimer's disease within a virtual senior residence: study protocol.

    Science.gov (United States)

    Davis, Rebecca; Ohman, Jennifer

    2016-07-01

    To report a study protocol that examines the impact of adding salient cues in a virtual reality simulation of a senior residential building on wayfinding for older adults with and without Alzheimer's disease. An early symptom of Alzheimer's disease is the inability to find one's way (wayfinding). Senior residential environments are especially difficult for wayfinding. Salient cues may be able to help persons with Alzheimer's disease find their way more effectively so they can maintain independence. A repeated measures, within and between subjects design. This study was funded by the National Institutes of Health (August 2012). Older adults (N = 40) with normal cognition and older adults with early stage Alzheimer's disease/mild cognitive impairment (N = 40) will try to find their way to a location repeatedly in a virtual reality simulation of senior residence. There are two environments: standard (no cues) and salient (multiple cues). Outcome measures include how often and how quickly participants find the target location in each cue condition. The results of this study have the potential to provide evidence for ways to make the environment more supportive for wayfinding for older adults with Alzheimer's disease. This study is registered at Trialmatch.alz.org (Identifier 260425-5). © 2016 John Wiley & Sons Ltd.

  12. TABADO: "Evaluation of a smoking cessation program among Adolescents in Vocational Training Centers": Study protocol

    Directory of Open Access Journals (Sweden)

    Martinet Yves

    2009-11-01

    Full Text Available Abstract Background Most of the efforts to reduce teenagers' tobacco addiction have focused on smoking prevention and little on smoking cessation. A smoking cessation program (TABADO study, associating pharmacologic and cognitive-behavioural strategy, on a particularly vulnerable population (vocational trainees, was developed. This study aims to evaluate the efficacy of the program which was offered to all smokers in a population aged 15 to 20 years in Vocational Training Centers (VTC. This paper presents the TABADO study protocol. Methods The study is quasi-experimental, prospective, evaluative and comparative and takes place during the 2 years of vocational training. The final population will be composed of 2000 trainees entering a VTC in Lorraine, France, during the 2008-2009 period. The intervention group (1000 trainees benefited from the TABADO program while no specific intervention took place in the "control" group (1000 trainees other than the treatment and education services usually available. Our primary outcome will be the tobacco abstinence rate at 12 months. Discussion If the program proves effective, it will be a new tool in the action against smoking in populations that have been seldom targeted until now. In addition, the approach could be expanded to other young subjects from socially disadvantaged backgrounds in the context of a public health policy against smoking among adolescents. Trial registration Clinical trial identification number is NTC00973570.

  13. Acupuncture for post anaesthetic recovery and postoperative pain: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Fleckenstein, Johannes; Baeumler, Petra I; Gurschler, Caroline; Weissenbacher, Tobias; Simang, Michael; Annecke, Thorsten; Geisenberger, Thomas; Irnich, Dominik

    2014-07-21

    We report on the design and implementation of a study protocol entitled Acupuncture randomised trial for post anaesthetic recovery and postoperative pain - a pilot study (ACUARP) designed to investigate the effectiveness of acupuncture therapy performed in the perioperative period on post anaesthetic recovery and postoperative pain. The study is designed as a randomised controlled pilot trial with three arms and partial double blinding. We will compare (a) press needle acupuncture, (b) no treatment and (c) press plaster acupressure in a standardised anaesthetic setting. Seventy-five patients scheduled for laparoscopic surgery to the uterus or ovaries will be allocated randomly to one of the three trial arms. The total observation period will begin one day before surgery and end on the second postoperative day. Twelve press needles and press plasters are to be administered preoperatively at seven acupuncture points. The primary outcome measure will be time from extubation to 'ready for discharge' from the post anaesthesia care unit (in minutes). The 'ready for discharge' end point will be assessed using three different scores: the Aldrete score, the Post Anaesthetic Discharge Scoring System and an In-House score. Secondary outcome measures will comprise pre-, intra- and postoperative variables (which are anxiety, pain, nausea and vomiting, concomitant medication). The results of this study will provide information on whether acupuncture may improve patient post anaesthetic recovery. Comparing acupuncture with acupressure will provide insight into potential therapeutic differences between invasive and non-invasive acupuncture techniques. NCT01816386 (First received: 28 October 2012).

  14. Comparison between stress myocardial perfusion SPECT recorded with cadmium-zinc-telluride and Anger cameras in various study protocols.

    Science.gov (United States)

    Verger, Antoine; Djaballah, Wassila; Fourquet, Nicolas; Rouzet, François; Koehl, Grégoire; Imbert, Laetitia; Poussier, Sylvain; Fay, Renaud; Roch, Véronique; Le Guludec, Dominique; Karcher, Gilles; Marie, Pierre-Yves

    2013-02-01

    The results of stress myocardial perfusion SPECT could be enhanced by new cadmium-zinc-telluride (CZT) cameras, although differences compared to the results with conventional Anger cameras remain poorly known for most study protocols. This study was aimed at comparing the results of CZT and Anger SPECT according to various study protocols while taking into account the influence of obesity. The study population, which was from three different institutions equipped with identical CZT cameras, comprised 276 patients referred for study using protocols involving (201)Tl (n = 120) or (99m)Tc-sestamibi injected at low dose at stress ((99m)Tc-Low; stress/rest 1-day protocol; n = 110) or at high dose at stress ((99m)Tc-High; rest/stress 1-day or 2-day protocol; n = 46). Each Anger SPECT scan was followed by a high-speed CZT SPECT scan (2 to 4 min). Agreement rates between CZT and Anger SPECT were good irrespective of the study protocol (for abnormal SPECT, (201)Tl 92 %, (99m)Tc-Low 86 %, (99m)Tc-High 98 %), although quality scores were much higher for CZT SPECT with all study protocols. Overall correlations were high for the extent of myocardial infarction (r = 0.80) and a little lower for ischaemic areas (r = 0.72), the latter being larger on Anger SPECT (p < 0.001). This larger extent was mainly observed in 50 obese patients who were in the (201)Tl or (99m)Tc-Low group and in whom stress myocardial counts were particularly low with Anger SPECT (228 ± 101 kcounts) and dramatically enhanced with CZT SPECT (+279 ± 251 %). Concordance between the results of CZT and Anger SPECT is good regardless of study protocol and especially when excluding obese patients who have low-count Anger SPECT and for whom myocardial counts are dramatically enhanced on CZT SPECT.

  15. A pilot study of an acupuncture protocol to improve visual function in retinitis pigmentosa patients.

    Science.gov (United States)

    Bittner, Ava K; Gould, Jeffrey M; Rosenfarb, Andy; Rozanski, Collin; Dagnelie, Gislin

    2014-05-01

    Patients with retinitis pigmentosa are motivated to try complementary or integrative therapies to slow disease progression. Basic science, clinical research and retinitis pigmentosa patients' self-reports support the hypothesis that acupuncture may improve visual function. A prospective, case series, pilot study enrolled 12 adult patients with RP treated at an academic medical centre with a standardised protocol that combined electroacupuncture to the forehead and below the eyes and acupuncture to the body, at 10 half-hour sessions over two weeks. Pre- and post-treatment tests included Early Treatment Diabetic Retinopathy Study visual acuity (VA), Pelli-Robson contrast sensitivity (CS), Goldmann visual fields, and dark-adapted full-field stimulus threshold (FST)(n = 9). Scotopic Sensitivity Tester-1 (SST-1) dark-adaptometry was performed on the last two subjects. Six of 12 subjects had measurable, significant visual function improvements after treatment. Three of nine subjects tested with the FST had a significant 10.3 to 17.5 dB (that is, 13- to 53-fold) improvement in both eyes at one week after acupuncture, maintained for at least 10 to 12 months, which was well outside typical test-retest variability (95% CI: 3-3.5 dB) previously found in retinitis pigmentosa. SST-1 dark-adaptation was shortened in both subjects tested on average by 48.5 per cent at one week (range 36 to 62 per cent across 10 to 30 dB), which was outside typical coefficients of variation of less than 30 per cent previously determined in patients with retinitis pigmentosa and normals. Four of the five subjects with psychophysically measured scotopic sensitivity improvements reported subjective improvements in vision at night or in dark environments. One subject had 0.2 logMAR improvement in VA; another had 0.55 logCS improvement. Another subject developed more than 20 per cent improvement in the area of the Goldmann visual fields. The acupuncture protocol was completed and well tolerated

  16. Peer mentorship to promote effective pain management in adolescents: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Hayes Loran P

    2011-05-01

    Full Text Available Abstract Background This protocol is for a study of a new program to improve outcomes in children suffering from chronic pain disorders, such as fibromyalgia, recurrent headache, or recurrent abdominal pain. Although teaching active pain self-management skills through cognitive-behavioral therapy (CBT or a complementary program such as hypnotherapy or yoga has been shown to improve pain and functioning, children with low expectations of skill-building programs may lack motivation to comply with therapists' recommendations. This study will develop and test a new manualized peer-mentorship program which will provide modeling and reinforcement by peers to other adolescents with chronic pain (the mentored participants. The mentorship program will encourage mentored participants to engage in therapies that promote the learning of pain self-management skills and to support the mentored participants' practice of these skills. The study will examine the feasibility of this intervention for both mentors and mentored participants, and will assess the preliminary effectiveness of this program on mentored participants' pain and functional disability. Methods This protocol will recruit adolescents ages 12-17 with chronic pain and randomly assign them to either peer mentorship or a treatment-as-usual control group. Mentored participants will be matched with peer mentors of similar age (ages 14-18 who have actively participated in various treatment modalities through the UCLA Pediatric Pain Program and have learned to function successfully with a chronic pain disorder. The mentors will present information to mentored participants in a supervised and monitored telephone interaction for 2 months to encourage participation in skill-building programs. The control group will receive usual care but without the mentorship intervention. Mentored and control subjects' pain and functioning will be assessed at 2 months (end of intervention for mentored participants and

  17. Design, Implementation, and Study Protocol of a Kindergarten-Based Health Promotion Intervention

    Directory of Open Access Journals (Sweden)

    Susanne Kobel

    2017-01-01

    Full Text Available Inactivity and an unhealthy diet amongst others have led to an increased prevalence of overweight and obesity even in young children. Since most health behaviours develop during childhood health promotion has to start early. The setting kindergarten has been shown as ideal for such interventions. “Join the Healthy Boat” is a kindergarten-based health promotion programme with a cluster-randomised study focussing on increased physical activity, reduced screen media use, and sugar-sweetened beverages, as well as a higher fruit and vegetable intake. Intervention and materials were developed using Bartholomew’s Intervention Mapping approach considering Bandura’s social-cognitive theory and Bronfenbrenner’s ecological framework for human development. The programme is distributed using a train-the-trainer approach and currently implemented in 618 kindergartens. The effectiveness of this one-year intervention with an intervention and a control group will be examined in 62 kindergartens using standardised protocols, materials, and tools for outcome and process evaluation. A sample of 1021 children and their parents provided consent and participated in the intervention. Results of this study are awaited to give a better understanding of health behaviours in early childhood and to identify strategies for effective health promotion. The current paper describes development and design of the intervention and its implementation and planned evaluation. Trial Registration. The study is registered at the German Clinical Trials Register (DRKS, Freiburg University, Germany, ID: DRKS00010089.

  18. Findings from the MATREX study: a treatment protocol for the delivery of manual chest therapy in respiratory care.

    Science.gov (United States)

    Cross, Jane; Elender, Frances

    2012-08-01

    One of the difficulties in comparing the numerous studies on manual chest therapy (MCT) is the wide variety of techniques used and terms employed to describe the intervention. This lack of consistency in therapeutic approach and the absence of defined tools for evaluation have led to a continued air of skepticism about its true value. This paper presents a treatment protocol used in a large randomized controlled trial examining the efficacy and cost effectiveness of MCT for patients hospitalized with exacerbations of COPD. Consensus development meetings with key physical therapists were held to identify the essential elements of MCT, address potential areas of ambiguity, and provide a set of clear parameters within which treatment would be based and recorded. This iterative approach resulted in a treatment protocol that combined best clinical practice with the research evidence available to date. In the Management of Exacerbations of COPD (MATREX) trial, 658 sessions of MCT were delivered by physical therapists over a 3 year period. A high level of adherence to the treatment protocol was seen for all but one of the protocol elements. With respect to the essential elements of MCT, the treatment protocol used in the MATREX trial offers sufficient flexibility to the therapist, while being robust enough to maintain clinical trial integrity. The level of adherence by therapists indicates its professional acceptability with respect to delivering and evaluating this therapy.

  19. Can the reporting of adverse skin reactions to cosmetics be improved? A prospective clinical study using a structured protocol.

    Science.gov (United States)

    Berne, Berit; Tammela, Monica; Färm, Gunilla; Inerot, Annica; Lindberg, Magnus

    2008-04-01

    The use of cosmetics is rising, and adverse reactions to these products are increasing. In Sweden, the Medical Products Agency (MPA) keeps a voluntary reporting system for such adverse reactions. However, the reporting is sparse, consisting almost only of cases with test-proven allergic contact dermatitis, thus under-reporting the more common irritant reactions. The aim of the study was to try to improve the reporting system. Dermatologists at 3 dermatology departments used a structured protocol during the clinical investigation of 151 consecutive patients reporting skin reactions to cosmetics. The protocol included symptoms, signs, affected body site, suspected products, and final diagnosis after patch testing. Based on clinical data and patch test results, a causality assessment for each product was made according to a protocol used at the MPA. Allergic contact dermatitis was found in 28% of the patients, and irritant reactions were equally common at 27%. Using this structured protocol, the cases of irritant dermatitis were also reported, and it is recommended that such a protocol is used as a standard to improve the reporting of adverse reactions to skin care products.

  20. Study of accent-based music speech protocol development for improving voice problems in stroke patients with mixed dysarthria.

    Science.gov (United States)

    Kim, Soo Ji; Jo, Uiri

    2013-01-01

    Based on the anatomical and functional commonality between singing and speech, various types of musical elements have been employed in music therapy research for speech rehabilitation. This study was to develop an accent-based music speech protocol to address voice problems of stroke patients with mixed dysarthria. Subjects were 6 stroke patients with mixed dysarthria and they received individual music therapy sessions. Each session was conducted for 30 minutes and 12 sessions including pre- and post-test were administered for each patient. For examining the protocol efficacy, the measures of maximum phonation time (MPT), fundamental frequency (F0), average intensity (dB), jitter, shimmer, noise to harmonics ratio (NHR), and diadochokinesis (DDK) were compared between pre and post-test and analyzed with a paired sample t-test. The results showed that the measures of MPT, F0, dB, and sequential motion rates (SMR) were significantly increased after administering the protocol. Also, there were statistically significant differences in the measures of shimmer, and alternating motion rates (AMR) of the syllable /K$\\inve$/ between pre- and post-test. The results indicated that the accent-based music speech protocol may improve speech motor coordination including respiration, phonation, articulation, resonance, and prosody of patients with dysarthria. This suggests the possibility of utilizing the music speech protocol to maximize immediate treatment effects in the course of a long-term treatment for patients with dysarthria.

  1. An internet-based adolescent depression preventive intervention: study protocol for a randomized control trial.

    Science.gov (United States)

    Gladstone, Tracy G; Marko-Holguin, Monika; Rothberg, Phyllis; Nidetz, Jennifer; Diehl, Anne; DeFrino, Daniela T; Harris, Mary; Ching, Eumene; Eder, Milton; Canel, Jason; Bell, Carl; Beardslee, William R; Brown, C Hendricks; Griffiths, Kathleen; Van Voorhees, Benjamin W

    2015-05-01

    The high prevalence of major depressive disorder in adolescents and the low rate of successful treatment highlight a pressing need for accessible, affordable adolescent depression prevention programs. The Internet offers opportunities to provide adolescents with high quality, evidence-based programs without burdening or creating new care delivery systems. Internet-based interventions hold promise, but further research is needed to explore the efficacy of these approaches and ways of integrating emerging technologies for behavioral health into the primary care system. We developed a primary care Internet-based depression prevention intervention, Competent Adulthood Transition with Cognitive Behavioral Humanistic and Interpersonal Training (CATCH-IT), to evaluate a self-guided, online approach to depression prevention and are conducting a randomized clinical trial comparing CATCH-IT to a general health education Internet intervention. This article documents the research framework and randomized clinical trial design used to evaluate CATCH-IT for adolescents, in order to inform future work in Internet-based adolescent prevention programs. The rationale for this trial is introduced, the current status of the study is reviewed, and potential implications and future directions are discussed. The current protocol represents the only current, systematic approach to connecting at-risk youth with self-directed depression prevention programs in a medical setting. This trial undertakes the complex public health task of identifying at-risk individuals through mass screening of the general primary care population, rather than solely relying on volunteers recruited over the Internet, and the trial design provides measures of both symptomatic and diagnostic clinical outcomes. At the present time, we have enrolled N = 234 adolescents/expected 400 and N = 186 parents/expected 400 in this trial, from N = 6 major health systems. The protocol described here provides a model

  2. Submission under the United Nations framework convention on climate change and Kyoto protocol 2010. National inventory report for the German greenhouse gas inventory 1990-2008; Berichterstattung unter der Klimarahmenkonvention der Vereinten Nationen und dem Kyoto-Protokoll 2010. Nationaler Inventarbericht zum Deutschen Treibhausgasinventar 1990-2008

    Energy Technology Data Exchange (ETDEWEB)

    Strogies, Michael; Gniffke, Patrick (comps.)

    2010-06-15

    As a Party to the United Nations Framework on Climate Change (UNFCCC), since 1994 Germany has been obliged to prepare, publish and regularly update national emission inventories of greenhouse gases. In February 2005, the Kyoto Protocol entered into force. As a result, for the first time ever the international community of nations is required to implement binding action objectives and instruments for global climate protection. This leads to extensive obligations vis-a-vis the preparation, reporting and review of emissions inventories. As a result of Europe's own implementation of the Kyoto Protocol, via the adoption of EU Decision 280/20041, these requirements became legally binding for Germany in spring 2004. Pursuant to Decision 3/CP.5, all The purpose of such reports is to ensure the transparency, consistency and comparability of inventories and support the independent review process. The Secretariat of the Framework Convention on Climate Change has made submission of the inventory report a pre-requisite for performance of the agreed inventory reviews. Germany now presents its eighth National Inventory Report (NIR 2010), following its inventories for the years 1990 to 2008. This latest report covers the same period (1990 to 2008), and it describes the methods and the data sources on which the calculations are based. This year, the NIR contains, for the first time, an additional Part II, along with additional sub-chapters in the existing part, in conformance with expanded requirements under the Kyoto Protocol and the relevant decisions at the European level. Part I of the NIR presents, in Chapters 1 to 10, all the information relevant to the annual greenhouse gas inventory. Chapter 1 provides background information about climate change and about greenhouse gas inventories, as well as further information relative to the Kyoto Protocol. In addition, this chapter describes the basic principles and methods with which the emissions and sinks of the IPCC categories

  3. Bio-repository of DNA in stroke: a study protocol of three ancestral populations

    Directory of Open Access Journals (Sweden)

    Ioana Cotlarciuc

    2012-07-01

    Full Text Available Stroke is a leading cause of death and disability in the world. Identifying the genes underlying stroke risk may help us to improve our understanding of the mechanisms that cause stroke and also identify novel therapeutic targets. To have sufficient power to disentangle the genetic component of stroke, large-scale highly phenotyped DNA repositories are necessary. The BRAINS (Bio-repository of DNA in stroke study aims to recruit subjects with all subtypes of stroke as well as controls from UK, India, Sri Lanka and Qatar. BRAINS-UK will include 1500 stroke patients of European ancestry as well as British South Asians. BRAINS-South Asia aims to recruit 3000 stroke subjects and 3000 controls from across India and Sri Lanka. BRAINS-Middle East aims to enrol 1500 stroke patients from Qatar. The controls for BRAINS-Middle East will be recruited from a population-based Qatari Biobank. With the addition of new recruitment centres in India and Qatar, we present an updated version of the BRAINS study protocol. This is the first international DNA biobank for stroke patients and controls from the Middle East. By investigating the influence of genetic factors on stroke risk in European, South Asian and Middle Eastern populations, BRAINS has the potential to improve our understanding of genetic differences between these groups and may lead to new population-specific therapeutic targets.

  4. A transdisciplinary approach to protocol development for tobacco control research: a case study.

    Science.gov (United States)

    Clark, Melissa A; Rogers, Michelle L; Boergers, Julie; Kahler, Christopher W; Ramsey, Susan; Saadeh, Frances M; Abrams, David B; Buka, Stephen L; Niaura, Raymond; Colby, Suzanne M

    2012-12-01

    The increasing complexity of scientific problems related to lifestyle risk factors has prompted substantial investments in transdisciplinary or team science initiatives at the biological, psychosocial, and population levels of analysis. To date, the actual process of conducting team science from the perspectives of investigators engaged in it has not been well documented. We describe the experience of developing and implementing data collection protocols using the principles of transdisciplinary science. The New England Family Study Transdisciplinary Tobacco Use Research Center was a 10-year collaboration involving more than 85 investigators and consultants from more than 20 disciplines as well as more than 50 research staff. We used a two-phase process in which all the study personnel participated in the developing and testing of 160 instruments. These instruments were used in 4,378 assessments with 3,501 participants. With substantial effort, it is possible to build a team of scientists from diverse backgrounds that can develop a set of instruments using a shared conceptual approach, despite limited or no experience working together previously.

  5. Acupuncture Antiarrhythmic Effects on Drug Refractory Persistent Atrial Fibrillation: Study Protocol for a Randomized, Controlled Trial

    Directory of Open Access Journals (Sweden)

    Jimin Park

    2015-01-01

    Full Text Available Background. Atrial fibrillation (AF is the most common form of arrhythmia. Several trials have suggested that acupuncture may prevent AF. However, the efficacy of acupuncture for AF prevention has not been well investigated. Therefore, we designed a prospective, two-parallel-armed, participant and assessor blinded, randomized, sham-controlled clinical trial to investigate acupuncture in persistent AF (ACU-AF. Methods. A total of 80 participants will be randomly assigned to active acupuncture or sham acupuncture groups in a 1 : 1 ratio. Both groups will take the same antiarrhythmic medication during the study period. Patients will receive 10 sessions of acupuncture treatment once a week for 10 weeks. The primary endpoint is AF recurrence rate. Secondary endpoints are left atrium (LA and left atrial appendage (LAA changes in function and volume, and inflammatory biomarker changes. Ethics. This study protocol was approved by the institutional review boards (IRBs of Kyung Hee University Hospital (number 1335-04. This trial is registered with clinicaltrials.gov NCT02110537.

  6. [Validation of the Italian Clinical Learning Environment Instrument (SVIAT):study protocol].

    Science.gov (United States)

    Palese, Alvisa; Destrebecq, Anne; Terzoni, Stefano; Grassetti, Luca; Altini, Pietro; Bevilacqua, Anita; Brugnolli, Anna; Benaglio, Carla; Dalponte, Adriana; De Biasio, Laura; Dimonte, Valerio; Gambacorti, Benedetta; Fasci, Adriana; Grosso, Silvia; Mansutti, Irene; Mantovan, Franco; Marognolli, Oliva; Montalti, Sandra; Nicotera, Raffaela; Perli, Serena; Randon, Giulia; Stampfl, Brigitte; Tollini, Morena; Canzan, Federica; Zannini, Lucia; Saiani, Luisa

    2016-01-01

    . Validation of the Italian Clinical Learning Environment Instrument (SVIAT): study protocol. Nursing students obtain most of their university credits in internship environments whose quality can affect their clinical learning. Several tools are available to measure the quality of the clinical learning environment (CLE) as perceived by students: these instruments developed in other countries, were validated in Italian but do not discriminate those CLEs capable (or not) to promote significant clinical learning. To validate an instrument to measure the capability of the CLE to generate clinical learning; the secondary aim is to describe the learning environments as perceived by nursing students according to individual course site and tutorial models adopted. The study will be developed in three phases: a) instrument development and pilot phase, b) validation of the psychometric properties of the instrument and c) description of the CLEs as perceived by the students including factors/item confirmed in the validation process. Expected outcomes. A large validation, with more than 8,000 participating students is expected; the construct under lying will be confirmed through exploratory and confirmatory factor analysis and will report high internal consistency; the instrument will report also a high test-retest and inter-rater reliability; in addition, the instrument will demonstrate predictive ability by discriminating those units able (or not) to activate effective learning processes.

  7. Early signaling, referral, and treatment of adolescent chronic pain: a study protocol

    Directory of Open Access Journals (Sweden)

    Voerman Jessica S

    2012-06-01

    Full Text Available Abstract Background Chronic pain is prevalent among young people and negatively influences their quality of life. Furthermore, chronic pain in adolescence may persist into adulthood. Therefore, it is important early on to promote the self-management skills of adolescents with chronic pain by improving signaling, referral, and treatment of these youngsters. In this study protocol we describe the designs of two complementary studies: a signaling study and an intervention study. Methods and design The signaling study evaluates the Pain Barometer, a self-assessed signaling instrument for chronic pain in adolescents. To evaluate the feasibility of the Pain Barometer, the experiences of youth-health care nurses will be evaluated in semi-structured interviews. Also, we will explore the frequencies of referral per health-care provider. The intervention study evaluates Move It Now, a guided self-help intervention via the Internet for teenagers with chronic pain. This intervention uses cognitive behavioural techniques, including relaxation exercises and positive thinking. The objective of the intervention is to improve the ability of adolescents to cope with pain. The efficacy of Move It Now will be examined in a randomized controlled trial, in which 60 adolescents will be randomly assigned to an experimental condition or a waiting list control condition. Discussion If the Pain Barometer is proven to be feasible and Move It Now appears to be efficacious, a health care pathway can be created to provide the best tailored treatment promptly to adolescents with chronic pain. Move It Now can be easily implemented throughout the Netherlands, as the intervention is Internet based. Trial registration Dutch Trial Register NTR1926

  8. A study protocol to evaluate the relationship between outdoor air pollution and pregnancy outcomes

    Directory of Open Access Journals (Sweden)

    Selemane Ismael

    2010-10-01

    Full Text Available Abstract Background The present study protocol is designed to assess the relationship between outdoor air pollution and low birth weight and preterm births outcomes performing a semi-ecological analysis. Semi-ecological design studies are widely used to assess effects of air pollution in humans. In this type of analysis, health outcomes and covariates are measured in individuals and exposure assignments are usually based on air quality monitor stations. Therefore, estimating individual exposures are one of the major challenges when investigating these relationships with a semi-ecologic design. Methods/Design Semi-ecologic study consisting of a retrospective cohort study with ecologic assignment of exposure is applied. Health outcomes and covariates are collected at Primary Health Care Center. Data from pregnant registry, clinical record and specific questionnaire administered orally to the mothers of children born in period 2007-2010 in Portuguese Alentejo Litoral region, are collected by the research team. Outdoor air pollution data are collected with a lichen diversity biomonitoring program, and individual pregnancy exposures are assessed with spatial geostatistical simulation, which provides the basis for uncertainty analysis of individual exposures. Awareness of outdoor air pollution uncertainty will improve validity of individual exposures assignments for further statistical analysis with multivariate regression models. Discussion Exposure misclassification is an issue of concern in semi-ecological design. In this study, personal exposures are assigned to each pregnant using geocoded addresses data. A stochastic simulation method is applied to lichen diversity values index measured at biomonitoring survey locations, in order to assess spatial uncertainty of lichen diversity value index at each geocoded address. These methods assume a model for spatial autocorrelation of exposure and provide a distribution of exposures in each study location

  9. Comparison of two oestrus synchronisation protocols administered to dairy cows during routine reproduction services

    DEFF Research Database (Denmark)

    Viora, L; Denwood, M; Ellis, K

    2015-01-01

    Progesterone-based oestrus synchronisation protocols are frequently used for treatment of cows presented for examination during routine reproduction management service. This study aimed to evaluate the effect of the addition of gonadotrophin-releasing hormone (GnRH) at the start of a progesterone......-based oestrus synchronisation protocol for cows presented for examination during routine veterinary service on a commercial dairy farm over 10 months. Overall 139 animals were retained in the study, of which 78 received a standard progesterone-based treatment (STD) and 61 received the same treatment...... (CR). In the final SR model lameness had a significant negative association (p=0.01) and STD+ had a non-significant positive association (p=0.12) with submission. In the final CR model only presence of a new CL at day 7 had a significant positive association (p=0.04) while previous reproductive...

  10. Optimal Scanning Protocols for Dual-Energy CT Angiography in Peripheral Arterial Stents: An in Vitro Phantom Study

    Directory of Open Access Journals (Sweden)

    Abdulrahman Almutairi

    2015-05-01

    Full Text Available Objective: To identify the optimal dual-energy computed tomography (DECT scanning protocol for peripheral arterial stents while achieving a low radiation dose, while still maintaining diagnostic image quality, as determined by an in vitro phantom study. Methods: Dual-energy scans in monochromatic spectral imaging mode were performed on a peripheral arterial phantom with use of three gemstone spectral imaging (GSI protocols, three pitch values, and four kiloelectron volts (keV ranges. A total of 15 stents of different sizes, materials, and designs were deployed in the phantom. Image noise, the signal-to-noise ratio (SNR, different levels of adaptive statistical iterative reconstruction (ASIR, and the four levels of monochromatic energy for DECT imaging of peripheral arterial stents were measured and compared to determine the optimal protocols. Results: A total of 36 scans with 180 datasets were reconstructed from a combination of different protocols. There was a significant reduction of image noise with a higher SNR from monochromatic energy images between 65 and 70 keV in all investigated preset GSI protocols (p < 0.05. In addition, significant effects were found from the main effect analysis for these factors: GSI, pitch, and keV (p = 0.001. In contrast, there was significant interaction on the unstented area between GSI and ASIR (p = 0.015 and a very high significant difference between keV and ASIR (p < 0.001. A radiation dose reduction of 50% was achieved. Conclusions: The optimal scanning protocol and energy level in the phantom study were GSI-48, pitch value 0.984, and 65 keV, which resulted in lower image noise and a lower radiation dose, but with acceptable diagnostic images.

  11. Integrating addiction treatment into primary care using mobile health technology: protocol for an implementation research study.

    Science.gov (United States)

    Quanbeck, Andrew R; Gustafson, David H; Marsch, Lisa A; McTavish, Fiona; Brown, Randall T; Mares, Marie-Louise; Johnson, Roberta; Glass, Joseph E; Atwood, Amy K; McDowell, Helene

    2014-05-29

    Healthcare reform in the United States is encouraging Federally Qualified Health Centers and other primary-care practices to integrate treatment for addiction and other behavioral health conditions into their practices. The potential of mobile health technologies to manage addiction and comorbidities such as HIV in these settings is substantial but largely untested. This paper describes a protocol to evaluate the implementation of an E-Health integrated communication technology delivered via mobile phones, called Seva, into primary-care settings. Seva is an evidence-based system of addiction treatment and recovery support for patients and real-time caseload monitoring for clinicians. Our implementation strategy uses three models of organizational change: the Program Planning Model to promote acceptance and sustainability, the NIATx quality improvement model to create a welcoming environment for change, and Rogers's diffusion of innovations research, which facilitates adaptations of innovations to maximize their adoption potential. We will implement Seva and conduct an intensive, mixed-methods assessment at three diverse Federally Qualified Healthcare Centers in the United States. Our non-concurrent multiple-baseline design includes three periods - pretest (ending in four months of implementation preparation), active Seva implementation, and maintenance - with implementation staggered at six-month intervals across sites. The first site will serve as a pilot clinic. We will track the timing of intervention elements and assess study outcomes within each dimension of the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework, including effects on clinicians, patients, and practices. Our mixed-methods approach will include quantitative (e.g., interrupted time-series analysis of treatment attendance, with clinics as the unit of analysis) and qualitative (e.g., staff interviews regarding adaptations to implementation protocol) methods, and assessment of

  12. Acupuncture, Counseling, and Usual care for Depression (ACUDep: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    MacPherson Hugh

    2012-11-01

    Full Text Available Abstract Background The evidence on the effect of acupuncture or counseling for depression is not conclusive yet is sufficient to warrant further research. Our aim is to conduct a full-scale RCT to determine the clinical and cost effectiveness of acupuncture and counseling compared to usual care alone. We will explore the experiences and perspectives of patients and practitioners. Methods/Design Randomized controlled trial with three parallel arms: acupuncture plus usual care, counseling plus usual care, and usual care alone, in conjunction with a nested qualitative study using in-depth interviews with purposive samples of trial participants. Participants: Patients aged over 18 years diagnosed with depression or mood disorder by their GP and with a score of 20 or above on the Beck Depression Inventory (BDI-II. Randomization: Computer randomization by York Trials Unit to acupuncture, counseling, and usual care alone in proportions of 2:2:1, respectively, with secure allocation concealment. Interventions: Patients allocated to acupuncture and counseling groups receive the offer of up to 12 weekly sessions. Both interventions allow flexibility to address patient variation, yet are constrained within defined protocols. Acupuncture is based on traditional Chinese medicine and counseling is non-directive within the humanistic tradition. Outcome: The PHQ-9 is the primary outcome measure, collected at baseline, 3, 6, 9, and 12 months. Also measured is BDI-II, SF-36 Bodily pain subscale, and EQ-5D. Texted mood scores are collected weekly over the first 15 weeks. Health-related resource use is collected over 12 months. Analysis: The sample size target was for 640 participants, calculated for an effect size of 0.32 on the PHQ-9 when comparing acupuncture with counseling given 90% power, 5% significance, and 20% loss to follow-up. Analysis of covariance will be used on an intention-to-treat basis. Thematic analysis will be used for qualitative data. We will

  13. Learning from positively deviant wards to improve patient safety: an observational study protocol.

    Science.gov (United States)

    Baxter, Ruth; Taylor, Natalie; Kellar, Ian; Lawton, Rebecca

    2015-12-11

    Positive deviance is an asset-based approach to improvement which has recently been adopted to improve quality and safety within healthcare. The approach assumes that solutions to problems already exist within communities. Certain groups or individuals identify these solutions and succeed despite having the same resources as others. Within healthcare, positive deviance has previously been applied at individual or organisational levels to improve specific clinical outcomes or processes of care. This study explores whether the positive deviance approach can be applied to multidisciplinary ward teams to address the broad issue of patient safety among elderly patients. Preliminary work analysed National Health Service (NHS) Safety Thermometer data from 34 elderly medical wards to identify 5 'positively deviant' and 5 matched 'comparison' wards. Researchers are blinded to ward status. This protocol describes a multimethod, observational study which will (1) assess the concurrent validity of identifying positively deviant elderly medical wards using NHS Safety Thermometer data and (2) generate hypotheses about how positively deviant wards succeed. Patient and staff perceptions of safety will be assessed on each ward using validated surveys. Correlation and ranking analyses will explore whether this survey data aligns with the routinely collected NHS Safety Thermometer data. Staff focus groups and researcher fieldwork diaries will be completed and qualitative thematic content analysis will be used to generate hypotheses about the strategies, behaviours, team cultures and dynamics that facilitate the delivery of safe patient care. The acceptability and sustainability of strategies identified will also be explored. The South East Scotland Research Ethics Committee 01 approved this study (reference: 14/SS/1085) and NHS Permissions were granted from all trusts. Findings will be published in peer-reviewed, scientific journals, and presented at academic conferences. This study

  14. Electroacupuncture for tapering off long-term benzodiazepine use: study protocol of randomized controlled trial.

    Science.gov (United States)

    Yeung, Wing-Fai; Chung, Ka-Fai; Zhang, Zhang-Jin; Chan, Wai-Chi; Zhang, Shi-Ping; Ng, Roger Man-Kin; Chan, Connie Lai-Wah; Ho, Lai-Ming; Yu, Yee-Man; Lao, Li-Xing

    2017-03-31

    Conventional approaches for benzodiazepine tapering have their limitations. Anecdotal studies have shown that acupuncture is a potential treatment for facilitating successful benzodiazepine tapering. As of today, there was no randomized controlled trial examining its efficacy and safety. The purpose of the study is to evaluate the efficacy of using electroacupuncture as an adjunct treatment to gradual tapering of benzodiazepine doses in complete benzodiazepine cessation in long-term benzodiazepine users. The study protocol of a randomized, assessor- and subject-blinded, controlled trial is presented. One hundred and forty-four patients with histories of using benzodiazepines in ≥50% of days for more than 3 months will be randomly assigned in a 1:1 ratio to receive either electroacupuncture or placebo electroacupuncture combined with gradual benzodiazepine tapering schedule. Both experimental and placebo treatments will be delivered twice per week for 4 weeks. Major assessments will be conducted at baseline, week 6 and week 16 post-randomization. Primary outcome is the cessation rate of benzodiazepine use. Secondary outcomes include the percentage change in the doses of benzodiazepine usage and the severity of withdrawal symptoms experienced based on the Benzodiazepine Withdrawal Symptom Questionnaire, insomnia as measured by the Insomnia Severity Index, and anxiety and depressive symptoms as evaluated by the Hospital Anxiety and Depression Scale. Adverse events will also be measured at each study visit. Results of this study will provide high quality evidence of the efficacy and safety of electroacupuncture as an adjunct treatment for benzodiazepine tapering in long-term users. ClinicalTrials.gov NCT02475538 .

  15. Effects of chronic inflammatory bowel diseases on left ventricular structure and function: a study protocol

    Directory of Open Access Journals (Sweden)

    Botti Fiorenzo

    2002-09-01

    Full Text Available Abstract Background Experimental evidences suggest an increased collagen deposition in inflammatory bowel diseases (IBD. In particular, large amounts of collagen type I, III and V have been described and correlated to the development of intestinal fibrotic lesions. No information has been available until now about the possible increased collagen deposition far from the main target organ. In the hypothesis that chronic inflammation and increased collagen metabolism are reflected also in the systemic circulation, we aimed this study to evaluate the effects on left ventricular wall structure by assessing splancnic and systemic collagen metabolism (procollagen III assay, deposition (ultrasonic tissue characterization, and cardiac function (echocardiography in patients with different long standing history of IBD, before and after surgery. Methods Thirty patients affected by active IBD, 15 with Crohn and 15 with Ulcerative Colitis, submitted to surgery will be enrolled in the study in a double blind fashion. They will be studied before the surgical operation and 6, 12 months after surgery. A control group of 15 healthy age and gender-matched subjects will also be studied. At each interval blood samples will be collected in order to assess the collagen metabolism; a transthoracic echocardiogram will be recorded for the subsequent determination of cardiac function and collagen deposition. Discussion From this study protocol we expect additional information about the association between IBD and cardiovascular disorders; in particular to address the question if chronic inflammation, through the altered collagen metabolism, could affect left ventricular structure and function in a manner directly related to the estimated duration of the disease.

  16. Acute symptoms related to air pollution in urban areas: a study protocol

    Directory of Open Access Journals (Sweden)

    Forouzanfar Mohammad

    2006-08-01

    Full Text Available Abstract Background The harmful effects of urban air pollution on general population in terms of annoying symptoms are not adequately evaluated. This is in contrast to the hospital admissions and short term mortality. The present study protocol is designed to assess the association between the level of exposure to certain ambient air pollutants and a wide range of relevant symptoms. Awareness of the impact of pollution on the population at large will make our estimates of the pertinent covert burden imposed on the society more accurate. Methods/design A cross sectional study with spatial analysis for the addresses of the participants was conducted. Data were collected via telephone interviews administered to a representative sample of civilians over age four in the city. Households were selected using random digit dialling procedures and randomization within each household was also performed to select the person to be interviewed. Levels of exposure are quantified by extrapolating the addresses of the study population over the air pollution matrix of the city at the time of the interview and also for different lag times. This information system uses the data from multiple air pollution monitoring stations in conjunction with meteorological data. General linear models are applied for statistical analysis. Discussion The important limitations of cross-sectional studies on acute effects of air pollution are personal confounders and measurement error for exposure. A wide range of confounders in this study are controlled for in the statistical analysis. Exposure error may be minimised by employing a validated geographical information system that provides accurate estimates and getting detailed information on locations of individual participants during the day. The widespread operation of open air conditioning systems in the target urban area which brings about excellent mixing of the outdoor and indoor air increases the validity of outdoor pollutants

  17. Pedestrian Road-Crossing Behaviours: A Protocol for an Explanatory Mixed Methods Study

    Science.gov (United States)

    Hashemiparast, Mina; Montazeri, Ali; Nedjat, Saharnaz; Negarandeh, Reza; Sadeghi, Roya; Hosseini, Masoumeh; Garmaroudi, Gholamreza

    2016-01-01

    Background: Pedestrian crossing is an important traffic safety concern. The aim of this paper is to report the protocol for a sequential explanatory mixed methods study that set out to determine the pedestrians’ traffic behaviors, the associated factors and exploring the perception of young people about the traffic risky behaviors in crossing the road. The ultimate purpose of the study is to design a preventive and cultural based strategy to promote young people’s health. Methods: This is a sequential explanatory mixed methods design. The study has two sequential phases. During the first phase, a population-based cross-sectional survey of a sample of young people will be conducted using the proportional random multistage cluster sampling method, in Tehran, Iran. Data will be collected by a questionnaire including items on socio-demographic information, items on measuring social conformity tendency, and questions on subjective norms, attitudes, and perceived behavioral control based on the Theory of Planned behavior. In the second phase, a qualitative study will be conducted. A purposeful sampling strategy will be used and participants who can help to explain the quantitative findings will be selected. Data collection in qualitative phase will be predominately by individual in-depth interviews. A qualitative content analysis approach will be undertaken to develop a detailed understanding of the traffic risky behaviors among young pedestrians. Conclusion: The findings of this explanatory mixed methods study will provide information on traffic risky behaviors in young pedestrians. The findings will be implemented to design a cultural based strategy and intervention programs. PMID:26652086

  18. A study protocol for Truce: a pragmatic controlled trial of a seven-week acceptance and commitment therapy program for young people who have a parent with cancer

    National Research Council Canada - National Science Library

    Patterson, Pandora; McDonald, Fiona E J; Ciarrochi, Joseph; Hayes, Louise; Tracey, Danielle; Wakefield, Claire E; White, Kate

    2015-01-01

    This paper presents the rationale and study protocol for a pragmatic controlled effectiveness trial of Truce, a prevention-based selective intervention targeting the significant mental health needs...

  19. Evaluating newly acquired authority of nurse practitioners and physician assistants for reserved medical procedures in the Netherlands: a study protocol

    OpenAIRE

    De Bruijn-Geraets, Daisy P; Van Eijk-Hustings, Yvonne JL; Vrijhoef, Hubertus JM

    2014-01-01

    Aim The study protocol is designed to evaluate the effects of granting independent authorization for medical procedures to nurse practitioners and physician assistants on processes and outcomes of health care. Background Recent (temporarily) enacted legislation in Dutch health care authorizes nurse practitioners and physician assistants to indicate and perform specified medical procedures, i.e. catheterization, cardioversion, defibrillation, endoscopy, injection, puncture, prescribing and sim...

  20. Teaching and Learning Foreign Languages via System of "Voice over Internet Protocol" and Language Interactions Case Study: Skype

    Science.gov (United States)

    Wahid, Wazira Ali Abdul; Ahmed, Eqbal Sulaiman; Wahid, Muntaha Ali Abdul

    2015-01-01

    This issue expresses a research study based on the online interactions of English teaching specially conversation through utilizing VOIP (Voice over Internet Protocol) and cosmopolitan online theme. Data has been achieved by interviews. Simplifiers indicate how oral tasks require to be planned upon to facilitate engagement models propitious to…

  1. Teacher's Perceptions of Sheltered Instruction Observation Protocol for Teaching Young English Language Learners: A Qualitative Case Study

    Science.gov (United States)

    Rodriguez Moux, Shirley

    2010-01-01

    This qualitative case study explored the use of sheltered instruction observation protocol (SIOP) instructional practices to promote the language development and learning of elementary English language learners (ELLs) in an immersion setting in 1st and 2nd grades. The SIOP model was developed for middle school ELLs, and there is scant information…

  2. Characterisation of exposure to non-ionising electromagnetic fields in the Spanish INMA birth cohort: Study protocol

    NARCIS (Netherlands)

    M. Gallastegi (Mara); M. Guxens Junyent (Mònica); A. Jiménez-Zabala (Ana); I. Calvente (Irene); M. Fernández (Marta); L. Birks (Laura); B. Struchen (Benjamin); M. Vrijheid (Martine); M. Estarlich (Marisa); M.F. Fernandez (Mariana); M. Torrent (Maties); F. Ballester (Ferran); J.J. Aurrekoetxea (Juan José); J. Ibarluzea (Jesús); D. Guerra (David); J. González (Julián); M. Röösli (Martin); L. Santa-Marina (Loreto)

    2016-01-01

    textabstractBackground: Analysis of the association between exposure to electromagnetic fields of non-ionising radiation (EMF-NIR) and health in children and adolescents is hindered by the limited availability of data, mainly due to the difficulties on the exposure assessment. This study protocol

  3. Effectiveness of the Health Complex Model in Iranian primary health care reform: the study protocol.

    Science.gov (United States)

    Tabrizi, Jafar Sadegh; Farahbakhsh, Mostafa; Sadeghi-Bazargani, Homayoun; Hassanzadeh, Roya; Zakeri, Akram; Abedi, Leili

    2016-01-01

    Iranian traditional primary health care (PHC) system, although proven to be successful in some areas in rural populations, suffers major pitfalls in providing PHC services in urban areas especially the slum urban areas. The new government of Iran announced a health reform movement including the health reform in PHC system of Iran. The Health Complex Model (HCM) was chosen as the preferred health reform model for this purpose. This paper aims to report a detailed research protocol for the assessment of the effectiveness of the HCM in Iran. An adaptive controlled design is being used in this research. The study is planned to measure multiple endpoints at the baseline and 2 years after the intervention. The assessments will be done both in a population covered by the HCM, as intervention area, and in control populations covered by the traditional health care system as the control area. Assessing the effectiveness of the HCM, as the Iranian PHC reform initiative, could help health system policy makers for future decisions on its continuation or modification.

  4. Strategy and rationale for urine collection protocols employed in the NEPTUNE study.

    Science.gov (United States)

    Hogan, Marie C; Lieske, John C; Lienczewski, Chrysta C; Nesbitt, Lisa L; Wickman, Larysa T; Heyer, Christina M; Harris, Peter C; Ward, Christopher J; Sundsbak, Jamie L; Manganelli, Luca; Ju, Wenjun; Kopp, Jeffrey B; Nelson, Peter J; Adler, Sharon G; Reich, Heather N; Holzmann, Lawrence B; Kretzler, Matthias; Bitzer, Markus

    2015-11-17

    Glomerular diseases are potentially fatal, requiring aggressive interventions and close monitoring. Urine is a readily-accessible body fluid enriched in molecular signatures from the kidney and therefore particularly suited for routine clinical analysis as well as development of non-invasive biomarkers for glomerular diseases. The Nephrotic Syndrome Study Network (NEPTUNE; ClinicalTrials.gov Identifier NCT01209000) is a North American multicenter collaborative consortium established to develop a translational research infrastructure for nephrotic syndrome. This includes standardized urine collections across all participating centers for the purpose of discovering non-invasive biomarkers for patients with nephrotic syndrome due to minimal change disease, focal segmental glomerulosclerosis, and membranous nephropathy. Here we describe the organization and methods of urine procurement and banking procedures in NEPTUNE. We discuss the rationale for urine collection and storage conditions, and demonstrate the performance of three experimental analytes (neutrophil gelatinase-associated lipocalin [NGAL], retinol binding globulin, and alpha-1 microglobulin) under these conditions with and without urine preservatives (thymol, toluene, and boric acid). We also demonstrate the quality of RNA and protein collected from the urine cellular pellet and exosomes. The urine collection protocol in NEPTUNE allows robust detection of a wide range of proteins and RNAs from urine supernatant and pellets collected longitudinally from each patient over 5 years. Combined with the detailed clinical and histopathologic data, this provides a unique resource for exploration and validation of new or accepted markers of glomerular diseases. ClinicalTrials.gov Identifier NCT01209000.

  5. Effective protein extraction protocol for proteomics studies of Jerusalem artichoke leaves.

    Science.gov (United States)

    Zhang, Meide; Shen, Shihua

    2013-07-01

    Protein extraction is a crucial step for proteomics studies. To establish an effective protein extraction protocol suitable for two-dimensional electrophoresis (2DE) analysis in Jerusalem artichoke (Helianthus tuberosus L.), three different protein extraction methods-trichloroacetic acid/acetone, Mg/NP-40, and phenol/ammonium acetate-were evaluated using Jerusalem artichoke leaves as source materials. Of the three methods, trichloroacetic acid/acetone yielded the best protein separation pattern and highest number of protein spots in 2DE analysis. Proteins highly abundant in leaves, such as Rubisco, are typically problematic during leaf 2DE analysis, however, and this disadvantage was evident using trichloroacetic acid/acetone. To reduce the influence of abundant proteins on the detection of low-abundance proteins, we optimized the trichloroacetic acid/acetone method by incorporating a PEG fractionation approach. After optimization, 363 additional (36.2%) protein spots were detected on the 2DE gel. Our results suggest that trichloroacetic acid/acetone method is a better protein extraction technique than Mg/NP-40 and phenol/ammonium acetate in Jerusalem artichoke leaf 2DE analysis, and that trichloroacetic acid/acetone method combined with PEG fractionation procedure is the most effective approach for leaf 2DE analysis of Jerusalem artichoke. © 2013 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  6. Acupuncture for functional dyspepsia: study protocol for a two-center, randomized controlled trial.

    Science.gov (United States)

    Han, Gajin; Ko, Seok-Jae; Park, Jae-Woo; Kim, Jinsung; Yeo, Inkwon; Lee, Hyejung; Kim, Song-Yi; Lee, Hyangsook

    2014-03-22

    Functional dyspepsia (FD) is a common health problem currently without any optimal treatments. Acupuncture has been traditionally sought as a treatment for FD. The aim of this study is to investigate whether acupuncture treatment helps improve symptoms of FD. A two-center, randomized, waitlist-controlled trial will be carried out to evaluate whether acupuncture treatment improves FD symptoms. Seventy six participants aged 18 to 75 years with FD as diagnosed by Rome III criteria will be recruited from August 2013 to January 2014 at two Korean Medicine hospitals. They will be randomly allocated either into eight sessions of partially individualized acupuncture treatment over 4 weeks or a waitlist group. The acupuncture group will then be followed-up for 3 weeks with six telephone visits and a final visit will be paid at 8 weeks. The waitlist group will receive the identical acupuncture treatment after a 4-week waiting period. The primary outcome is the proportion of responders with adequate symptom relief and the secondary outcomes include Nepean dyspepsia index, EQ-5D, FD-related quality of life, Beck's depression inventory, state-trait anxiety inventory questionnaire, and level of ghrelin hormone. The protocol was approved by the participating centers' Institutional Review Boards. Results of this trial will help clarify not only whether the acupuncture treatment is beneficial for symptom improvement in FD patients but also to elucidate the related mechanisms of how acupuncture might work. ClinicalTrials.gov Identifier: NCT01921504.

  7. A Pilot Study Involving the Effect of Two Different Complex Training Protocols on Lower Body Power

    Directory of Open Access Journals (Sweden)

    Smith Chad E.

    2014-09-01

    Full Text Available Purpose. Complex training (CT involves the coupling of two exercises ostensibly to enhance the effect of the second exercise. Typically, the first exercise is a strength exercise and the second exercise is a power exercise involving similar muscles. In most cases, CT is designed to enhance power. The purpose of this study was twofold. First, this study was designed to determine if lower body power could be enhanced using complex training protocols. Second, this study investigated whether the inclusion of a power exercise instead of a strength exercise as the first exercise in CT would produce differences in lower body power. Methods. Thirty-six recreationally-trained men and women aged 20 to 29 years attending a college physical education course were randomly assigned to one of three groups: squat and countermovement squat jumps (SSJ, kettlebell swings and countermovement squat jumps (KSJ, and a control (CON. Training involving CT lasted 6 weeks. All participants were pre- and posttested for vertical jump performance in order to assess lower body power. Results. Vertical jump scores improved for all groups (p < 0.01. The results also indicated that there were no statistically significant differences between group scores across time (p = 0.215. The statistical power for this analysis was low (0.312, most likely due to the small sample size. However, the results did reveal a trend suggesting that the training improvements were greater for both the SSJ and KSJ groups compared with the CON (by 171% and 107%, respectively although significance was not reached. Conclusions. Due to the observed trend, a replication of this study with a greater number of participants over a longer period of time is warranted.

  8. Peer-led healthy lifestyle program in supportive housing: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Cabassa, Leopoldo J; Stefancic, Ana; O'Hara, Kathleen; El-Bassel, Nabila; Lewis-Fernández, Roberto; Luchsinger, José A; Gates, Lauren; Younge, Richard; Wall, Melanie; Weinstein, Lara; Palinkas, Lawrence A

    2015-09-02

    The risk for obesity is twice as high in people with serious mental illness (SMI) compared to the general population. Racial and ethnic minority status contribute additional health risks. The aim of this study is to describe the protocol of a Hybrid Trial Type 1 design that will test the effectiveness and examine the implementation of a peer-led healthy lifestyle intervention in supportive housing agencies serving diverse clients with serious mental illness who are overweight or obese. The Hybrid Trial Type 1 design will combine a randomized effectiveness trial with a mixed-methods implementation study. The effectiveness trial will test the health impacts of a peer-led healthy lifestyle intervention versus usual care in supportive housing agencies. The healthy lifestyle intervention is derived from the Group Lifestyle Balanced Program, lasts 12 months, and will be delivered by trained peer specialists. Repeated assessments will be conducted at baseline and at 6, 12, and 18 months post randomization. A mixed-methods (e.g., structured interviews, focus groups, surveys) implementation study will be conducted to examine multi-level implementation factors and processes that can inform the use of the healthy lifestyle intervention in routine practice, using data from agency directors, program managers, staff, and peer specialists before, during, and after the implementation of the effectiveness trial. This paper describes the use of a hybrid research design that blends effectiveness trial methodologies and implementation science rarely used when studying the physical health of people with SMI and can serve as a model for integrating implementation science and health disparities research. Rigorously testing effectiveness and exploring the implementation process are both necessary steps to establish the evidence for large-scale delivery of peer-led healthy lifestyle intervention to improve the physical health of racial/ethnic minorities with SMI. www

  9. The Malaysian Breast Cancer Survivorship Cohort (MyBCC): a study protocol.

    Science.gov (United States)

    Islam, Tania; Bhoo-Pathy, Nirmala; Su, Tin Tin; Majid, Hazreen Abdul; Nahar, Azmi Mohd; Ng, Chong Guan; Dahlui, Maznah; Hussain, Samsinah; Cantwell, Marie; Murray, Liam; Taib, Nur Aishah

    2015-10-26

    Over recent decades, the burden of breast cancer has been increasing at an alarming rate in Asia. Prognostic research findings from Western countries may not readily be adapted to Asia, as the outcome of breast cancer depends on a multitude of factors ranging from genetic, clinical and histological predictors, to lifestyle and social predictors. The primary aim of this study is to determine the impact of lifestyle (eg, nutrition, physical activity), mental and sociocultural condition, on the overall survival and quality of life (QoL) among multiethnic Malaysian women following diagnosis of breast cancer. This study aims to advance the evidence on prognostic factors of breast cancer within the Asian setting. The findings may guide management of patients with breast cancer not only during active treatment but also during the survivorship period. This hospital-based prospective cohort study will comprise patients with breast cancer (18 years and above), managed in the University Malaya Medical Centre (UMMC). We aim to recruit 1000 cancer survivors over a 6-year period. Data collection will occur at baseline (within 3 months of diagnosis), 6 months, and 1, 3 and 5 years following diagnosis. The primary outcomes are disease-free survival and overall survival, and secondary outcome is QoL. Factors measured are demographic and socioeconomic factors, lifestyle factors (eg, dietary intake, physical activity), anthropometry measurements (eg, height, weight, waist, hip circumference, body fat analysis), psychosocial aspects, and complementary and alternative medicine (CAM) usage. This protocol was approved by the UMMC Ethical Committee in January 2012. All participants are required to provide written informed consent. The findings from our cohort study will be disseminated via scientific publication as well as presentation to stakeholders including the patients, clinicians, the public and policymakers, via appropriate avenues. Published by the BMJ Publishing Group

  10. DreamTel; Diabetes risk evaluation and management tele-monitoring study protocol

    Directory of Open Access Journals (Sweden)

    Kiss Alex

    2009-05-01

    Full Text Available Abstract Background The rising prevalence of type 2 diabetes underlines the importance of secondary strategies for the prevention of target organ damage. While access to diabetes education centers and diabetes intensification management has been shown to improve blood glucose control, these services are not available to all that require them, particularly in rural and northern areas. The provision of these services through the Home Care team is an advance that can overcome these barriers. Transfer of blood glucose data electronically from the home to the health care provider may improve diabetes management. Methods and design The study population will consist of patients with type 2 diabetes with uncontrolled A1c levels living on reserve in the Battlefords region of Saskatchewan, Canada. This pilot study will take place over three phases. In the first phase over three months the impact of the introduction of the Bluetooth enabled glucose monitor will be assessed. In the second phase over three months, the development of guidelines based treatment algorithms for diabetes intensification will be completed. In the third phase lasting 18 months, study subjects will have diabetes intensification according to the algorithms developed. Discussion The first phase will determine if the use of the Bluetooth enabled blood glucose devices which can transmit results electronically will lead to changes in A1c levels. It will also determine the feasibility of recruiting subjects to use this technology. The rest of the Diabetes Risk Evaluation and Management Tele-monitoring (DreamTel study will determine if the delivery of a diabetes intensification management program by the Home Care team supported by the Bluetooth enabled glucose meters leads to improvements in diabetes management. Trial Registration Protocol NCT00325624

  11. Promoting fit bodies, healthy eating and physical activity among Indigenous Australian men: a study protocol

    Directory of Open Access Journals (Sweden)

    Ricciardelli Lina A

    2012-01-01

    Full Text Available Abstract Background Overall the physical health of Indigenous men is among the worst in Australia. Research has indicated that modifiable lifestyle factors, such as poor nutrition and physical inactivity, appear to contribute strongly to these poor health conditions. To effectively develop and implement strategies to improve the health of Australia's Indigenous peoples, a greater understanding is needed of how Indigenous men perceive health, and how they view and care for their bodies. Further, a more systematic understanding of how sociocultural factors affect their health attitudes and behaviours is needed. This article presents the study protocol of a community-based investigation into the factors surrounding the health and body image of Indigenous Australian men. Methods and design The study will be conducted in a collaborative manner with Indigenous Australian men using a participatory action research framework. Men will be recruited from three locations around Australia (metropolitan, regional, and rural and interviewed to understand their experiences and perspectives on a number of issues related to health and health behaviour. The information that is collected will be analysed using modified grounded theory and thematic analysis. The results will then be used to develop and implement community events in each location to provide feedback on the findings to the community, promote health enhancing strategies, and determine future action and collaboration. Discussion This study will explore both risk and protective factors that affect the health of Indigenous Australian men. This knowledge will be disseminated to the wider Indigenous community and can be used to inform future health promotion strategies. The expected outcome of this study is therefore an increased understanding of health and health change in Indigenous Australian men, the development of strategies that promote healthy eating and positive patterns of physical activity and, in

  12. Impact of the implementation of electronic guidelines for cardiovascular prevention in primary care: study protocol

    Directory of Open Access Journals (Sweden)

    Eva Comin

    2013-03-01

    Full Text Available Background The electronic medical records software of the Catalan Institute of Health has recently incorporated an electronic version of clinical practice guidelines (e-CPGs. This study aims to assess the impact of the implementation of e-CPGs on the diagnosis, treatment, control and management of hypercholesterolaemia, diabetes mellitus type 2 and hypertension.Methods Eligible study participants are those aged 35–74 years assigned to family practitioners (FPs of the Catalan Institute of Health. Routinely collected data from electronic primary care registries covering 80% of the Catalan population will be analysed using two approaches: (1 a cross-sectional study to describe the characteristics of the sample before e-CPG implementation; (2 a controlled before-and-after study with 1-year follow-up to ascertain the effect of e-CPG implementation. Patients of FPs who regularly use the e-CPGs will constitute the intervention group; the control group will comprise patients assigned to FPs not regularly using the e-CPG. The outcomes are: (1 suspected and confirmed diagnoses, (2 control of clinical variables, (3 requests for tests and (4 proportions of patients with adequate drug prescriptions.Results This protocol should represent a reproducible process to assess the impact of the implementation of e-CPGs. We anticipate reporting results in late 2013.Conclusion This project will assess the effectiveness of e-CPGs to improve clinical decisions and healthcare procedures in the three disorders analysed. The results will shed light on the use of evidence-based medicine to improve clinical practice of FPs.

  13. Cross-cultural adaptation, evaluation and validation of the Spouse Response Inventory: a study protocol.

    Science.gov (United States)

    Kaiser, Ulrike; Steinmetz, Dorit; Scharnagel, Rüdiger; Jensen, Mark P; Balck, Friedrich; Sabatowski, Rainer

    2014-10-14

    Since the response of spouses has been proven to be an important reinforcement of pain behaviour and disability it has been addressed in research and therapy. Fordyce suggested pain behaviour and well behaviour be considered in explaining suffering in chronic pain patients. Among existing instruments concerning spouse's responses the aspect of well behaviour has not been examined so far. The SRI (Spouse Response Inventory) tries to consider pain behaviour and well behaviour and appears to be acceptable because of its brevity and close proximity to daily language. The aim of the study is the translation into German, followed by evaluation and validation, of the SRI on a German sample of patients with chronic pain. The study is comprehensively designed: initially, the focus will lie on the translation of the instrument following the guidelines for cross-cultural translation and adaptation and evaluation of the German version according to the source study. Subsequently, a validation referring to predictive, incremental and construct validation will be conducted using instruments based on similar or close but different constructs. Evaluation of the resulting SRI-G (SRI-German) will be conducted on a sample of at least 30 patients with chronic pain attending a comprehensive pain centre. For validation at least 120 patients with chronic headache, back pain, cancer related pain and somatoform pain disorder shall be included, for a total of 480 patients. Separate analyses according to specific pain diagnoses will be performed to ensure psychometric property, interpretability and control of diagnosis of specific limitations. Analyses will include comprehensive investigation of psychometric property of the scale by hierarchical regression analyses, correlation analyses, multivariate analysis of variance and exploratory factor analyses (SPSS). The study protocol was approved by the Ethics Committee of the University of Dresden (EK 335 122008) based on the Helsinki declaration

  14. Benchmarking pediatric cranial CT protocols using a dose tracking software system: a multicenter study

    Energy Technology Data Exchange (ETDEWEB)

    Bondt, Timo de; Parizel, Paul M. [Antwerp University Hospital and University of Antwerp, Department of Radiology, Antwerp (Belgium); Mulkens, Tom [H. Hart Hospital, Department of Radiology, Lier (Belgium); Zanca, Federica [GE Healthcare, DoseWatch, Buc (France); KU Leuven, Imaging and Pathology Department, Leuven (Belgium); Pyfferoen, Lotte; Casselman, Jan W. [AZ St. Jan Brugge-Oostende AV Hospital, Department of Radiology, Brugge (Belgium)

    2017-02-15

    To benchmark regional standard practice for paediatric cranial CT-procedures in terms of radiation dose and acquisition parameters. Paediatric cranial CT-data were retrospectively collected during a 1-year period, in 3 different hospitals of the same country. A dose tracking system was used to automatically gather information. Dose (CTDI and DLP), scan length, amount of retakes and demographic data were stratified by age and clinical indication; appropriate use of child-specific protocols was assessed. In total, 296 paediatric cranial CT-procedures were collected. Although the median dose of each hospital was below national and international diagnostic reference level (DRL) for all age categories, statistically significant (p-value < 0.001) dose differences among hospitals were observed. The hospital with lowest dose levels showed smallest dose variability and used age-stratified protocols for standardizing paediatric head exams. Erroneous selection of adult protocols for children still occurred, mostly in the oldest age-group. Even though all hospitals complied with national and international DRLs, dose tracking and benchmarking showed that further dose optimization and standardization is possible by using age-stratified protocols for paediatric cranial CT. Moreover, having a dose tracking system revealed that adult protocols are still applied for paediatric CT, a practice that must be avoided. (orig.)

  15. [PROtocol-based MObilizaTION on intensive care units : Design of a cluster randomized pilot study].

    Science.gov (United States)

    Nydahl, P; Diers, A; Günther, U; Haastert, B; Hesse, S; Kerschensteiner, C; Klarmann, S; Köpke, S

    2017-10-12

    Despite convincing evidence for early mobilization of patients on intensive care units (ICU), implementation in practice is limited. Protocols for early mobilization, including in- and exclusion criteria, assessments, safety criteria, and step schemes may increase the rate of implementation and mobilization. Patients (population) on ICUs with a protocol for early mobilization (intervention), compared to patients on ICUs without protocol (control), will be more frequently mobilized (outcome). A multicenter, stepped-wedge, cluster-randomized pilot study is presented. Five ICUs will receive an adapted, interprofessional protocol for early mobilization in randomized order. Before and after implementation, mobilization of ICU patients will be evaluated by randomized monthly one-day point prevalence surveys. Primary outcome is the percentage of patients mobilized out of bed, operationalized as a score of ≥3 on the ICU Mobility Scale. Secondary outcome parameters will be presence and/or length of mechanical ventilation, delirium, stay on ICU and in hospital, barriers to early mobilization, adverse events, and process parameters as identified barriers, used strategies, and adaptions to local conditions. Exploratory evaluation of study feasibility and estimation of effect sizes as the basis for a future explanatory study.

  16. Feasibility of an activity protocol for young children in a whole room indirect calorimeter: a proof-of-concept study.

    Science.gov (United States)

    Oortwijn, Anouk W M C; Plasqui, Guy; Reilly, John J; Okely, Anthony D

    2009-09-01

    The purpose of this pilot study was to assess the feasibility of a structured activity protocol in a room calorimeter among young children. Five healthy children (age 5.2 +/- 0.4 y) performed an activity protocol in a room calorimeter, ranging from sedentary to vigorous-intensity activities. Energy expenditure (EE) was calculated from continuous measurements of O2-consumption and CO2-production using Weir's formula. Resting EE was defined as EE during the first 30 min of the study where participants were seated while watching television. The children wore an ActiGraph accelerometer on the right and left hip. The protocol was well tolerated by all children, and lasted 150 to 175 min. Further, differences were seen in both EE and accelerometer counts across 3 of the 4 activity intensities. It is feasible for young children to perform a structured activity protocol in a room calorimeter enhancing the possibility of conducting future studies to cross-validate existing accelerometer prediction equations.

  17. The costs of stroke in Spain by aetiology: the CONOCES study protocol.

    Science.gov (United States)

    Mar, J; Álvarez-Sabín, J; Oliva, J; Becerra, V; Casado, M Á; Yébenes, M; González-Rojas, N; Arenillas, J F; Martínez-Zabaleta, M T; Rebollo, M; Lago, A; Segura, T; Castillo, J; Gállego, J; Jiménez-Martínez, C; López-Gastón, J I; Moniche, F; Casado-Naranjo, I; López-Fernández, J C; González-Rodríguez, C; Escribano, B; Masjuan, J

    2013-01-01

    Patients with stroke associated with non-valvular atrial fibrillation (NVAF) are a specific group, and their disease has a considerable social and economic impact. The primary objective of the CONOCES study, the protocol of which is presented here, is to compare the costs of stroke in NVAF patients to those of patients without NVAF in Spanish stroke units from a societal perspective. CONOCES is an epidemiological, observational, naturalistic, prospective, multicentre study of the cost of the illness in a sample of patients who have suffered a stroke and were admitted to a Spanish stroke unit. During a 12-month follow-up period, we record sociodemographic and clinical variables, score on the NIH stroke scale, level of disability, degree of functional dependency according to the modified Rankin scale, and use of healthcare resources (hospitalisation at the time of the first episode, readmissions, outpatient rehabilitation, orthotic and/or prosthetic material, medication for secondary prevention, medical check-ups, nursing care and formal social care services). Estimated monthly income, lost work productivity and health-related quality of life measured with the generic EQ-5D questionnaire are also recorded. We also administer a direct interview to the caregiver to determine loss of productivity, informal care, and caregiver burden. The CONOCES study will provide more in-depth information about the economic and clinical impact of stroke according to whether or not it is associated with NVAF. Copyright © 2012 Sociedad Española de Neurología. Published by Elsevier Espana. All rights reserved.

  18. Queensland Alcohol-related violence and Night Time Economy Monitoring project (QUANTEM: a study protocol

    Directory of Open Access Journals (Sweden)

    Peter G. Miller

    2017-10-01

    Full Text Available Abstract Background Alcohol-related harm is a substantial burden on the community in Australia and internationally, particularly harm related to risky drinking practices of young people in the night-time economy. This protocol paper describes a study that will report on the changes in a wide range of health and justice outcome measures associated with major policy changes in the state of Queensland, Australia. A key element includes trading hours restrictions for licensed premises to 2 am for the state and 3 am in Safe Night Precincts (SNPs. Other measures introduced include drinks restrictions after midnight, increased patron banning measures for repeat offenders, mandatory ID scanning of patrons in late-night venues, and education campaigns. Methods The primary aim of the study is to evaluate change in the levels of harm due to these policy changes using administrative data (e.g., police, hospital, ambulance, and court data. Other study elements will investigate the impact of the Policy by measuring foot traffic volume in SNPs, using ID scanner data to quantify the volume of people entering venues and measure the effectiveness of banning notices, using patron interviews to quantify the levels of pre-drinking, intoxication and illicit drug use within night-time economy districts, and to explore the impacts of the Policy on business and live music, and costs to the community. Discussion The information gathered through this project aims to evaluate the effectiveness of the Policy and to draw on these findings to inform future prevention and enforcement approaches by policy makers, police, and venue staff.

  19. Western Australian Public Opinions of a Minimum Pricing Policy for Alcohol: Study Protocol.

    Science.gov (United States)

    Keatley, David A; Carragher, Natacha; Chikritzhs, Tanya; Daube, Mike; Hardcastle, Sarah J; Hagger, Martin S

    2015-11-18

    Excessive alcohol consumption has significant adverse economic, social, and health outcomes. Recent estimates suggest that the annual economic costs of alcohol in Australia are up to AUD $36 billion. Policies influencing price have been demonstrated to be very effective in reducing alcohol consumption and alcohol-related harms. Interest in minimum pricing has gained traction in recent years. However, there has been little research investigating the level of support for the public interest case of minimum pricing in Australia. This article describes protocol for a study exploring Western Australian (WA) public knowledge, understanding, and reaction to a proposed minimum price policy per standard drink. The study will employ a qualitative methodological design. Participants will be recruited from a wide variety of backgrounds, including ethnic minorities, blue and white collar workers, unemployed, students, and elderly/retired populations to participate in focus groups. Focus group participants will be asked about their knowledge of, and initial reactions to, the proposed policy and encouraged to discuss how such a proposal may affect their own alcohol use and alcohol consumption at the population level. Participants will also be asked to discuss potential avenues for increasing acceptability of the policy. The focus groups will adopt a semi-structured, open-ended approach guided by a question schedule. The schedule will be based on feedback from pilot samples, previous research, and a steering group comprising experts in alcohol policy and pricing. The study is expected to take approximately 14 months to complete. The findings will be of considerable interest and relevance to government officials, policy makers, researchers, advocacy groups, alcohol retail and licensed establishments and organizations, city and town planners, police, and other stakeholder organizations.

  20. Western Australian Public Opinions of a Minimum Pricing Policy for Alcohol: Study Protocol

    Science.gov (United States)

    Keatley, David A; Daube, Mike; Hardcastle, Sarah J

    2015-01-01

    Background Excessive alcohol consumption has significant adverse economic, social, and health outcomes. Recent estimates suggest that the annual economic costs of alcohol in Australia are up to AUD $36 billion. Policies influencing price have been demonstrated to be very effective in reducing alcohol consumption and alcohol-related harms. Interest in minimum pricing has gained traction in recent years. However, there has been little research investigating the level of support for the public interest case of minimum pricing in Australia. Objective This article describes protocol for a study exploring Western Australian (WA) public knowledge, understanding, and reaction to a proposed minimum price policy per standard drink. Methods The study will employ a qualitative methodological design. Participants will be recruited from a wide variety of backgrounds, including ethnic minorities, blue and white collar workers, unemployed, students, and elderly/retired populations to participate in focus groups. Focus group participants will be asked about their knowledge of, and initial reactions to, the proposed policy and encouraged to discuss how such a proposal may affect their own alcohol use and alcohol consumption at the population level. Participants will also be asked to discuss potential avenues for increasing acceptability of the policy. The focus groups will adopt a semi-structured, open-ended approach guided by a question schedule. The schedule will be based on feedback from pilot samples, previous research, and a steering group comprising experts in alcohol policy and pricing. Results The study is expected to take approximately 14 months to complete. Conclusions The findings will be of considerable interest and relevance to government officials, policy makers, researchers, advocacy groups, alcohol retail and licensed establishments and organizations, city and town planners, police, and other stakeholder organizations. PMID:26582408

  1. Communicating risk in active surveillance of localised prostate cancer: a protocol for a qualitative study.

    Science.gov (United States)

    Rapport, Frances; Hogden, Anne; Gurney, Howard; Gillatt, David; Bierbaum, Mia; Shih, Patti; Churruca, Kate

    2017-10-05

    One in five men is likely to receive a diagnosis of prostate cancer (PCa) by the age of 85 years. Men diagnosed with low-risk PCa may be eligible for active surveillance (AS) to monitor their cancer to ensure that any changes are discovered and responded to in a timely way. Communication of risk in this context is more complicated than determining a numerical probability of risk, as patients wish to understand the implications of risk on their lives in concrete terms. Our study will examine how risk for PCa is perceived, experienced and communicated by patients using AS with their health professionals, and the implications for treatment and care. This is a proof of concept study, testing out a multimethod, qualitative approach to data collection in the context of PCa for the first time in Australia. It is being conducted from November 2016 to December 2017 in an Australian university hospital urology clinic. Participants are 10 men with a diagnosis of localised PCa, who are using an AS protocol, and 5 health professionals who work with this patient group (eg, urologists and Pca nurses). Data will be collected using observations of patient consultations with health professionals, patient questionnaires and interviews, and interviews with healthcare professionals. Analysis will be conducted in two stages. First, observational data from consultations will be analysed thematically to encapsulate various dimensions of risk classification and consultation dialogue. Second, interview data will be coded to derive meaning in text and analysed thematically. Overarching themes will represent patient and health professional perspectives of risk communication. Ethical approval for the study has been granted by Macquarie University Human Research Ethics Committee, approval 5201600638. Knowledge translation will be achieved through publications, reports and conference presentations to patients, families, clinicians and researchers. © Article author(s) (or their employer

  2. Parenting roles and knowledge in neonatal intensive care units: protocol of a mixed methods study.

    Science.gov (United States)

    Alves, Elisabete; Amorim, Mariana; Fraga, Sílvia; Barros, Henrique; Silva, Susana

    2014-07-10

    There is a strong focus on the translation of scientific knowledge into evidence-based practice when dealing with very preterm births. The aim is to standardise and rationalise healthcare. The incorporation of parents' perspectives with respect to the organisation of care and technical interventions in neonatal intensive care units (NICUs) is needed. This study aims to analyse the repertoire of meanings, knowledge and emotions actualised by the parents of very preterm infants hospitalised in NICUs in the decision process regarding parental care, treatment options and uses of information sources. This is a mixed-methods, observational study. The methodological strategy will rely on: (1) Ethnographic observation, carried out in a level III NICU located in the North of Portugal, during 6 months; (2) NICU-based surveys of mothers and fathers of very preterm infants born between July 2013 and June 2014 and admitted at the seven public level III NICUs of the Northern Health Region of Portugal; (3) Single and couple semistructured interviews to a subsample of mothers and fathers of very preterm infants, 4 months after birth. Inferential statistics will be used to analyse the quantitative data and content analysis, with an iterative and reflexive process and will be implemented to assess qualitative data. The study protocol was approved by the National Data Protection Commission and the Ethics Committee of all the hospitals involved. The current project will contribute to develop resources for enriched good medical practices in the context of neonatal services through integrating insights from social sciences, public health, epidemiology and ethics. The expected dissemination actions are effective tools in designing strategies that aim to develop family-centred care and to improve medical practices in the context of neonatal services. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  3. Sydney epilepsy incidence study to measure illness consequences: the SESIMIC observational epilepsy study protocol

    Directory of Open Access Journals (Sweden)

    Jan Stephen

    2011-01-01

    Full Text Available Abstract Background Epilepsy affects an estimated 50 million people and accounts for approximately 1% of days lost to ill health globally, making it one of the most common, serious neurological disorders. While there are abundant global data on epilepsy incidence, prevalence and treatment, there is a paucity of Australian incidence data. There is also a general lack of information on the psychosocial impact and socioeconomic consequences of a new diagnosis of epilepsy on an individual, their family, household, and community which are often specific to the health and social system of each country. Methods/Design The Sydney Epilepsy Incidence Study to Measure Illness Consequences (SEISMIC is an Australian population-based epilepsy incidence and outcome study that will recruit every newly diagnosed case of epilepsy in the Sydney South West Area Health Service to an epilepsy register. Multiple and overlapping sources of notification will be used to identify all new cases of epilepsy over a 24 month period in the Eastern Zone of the Sydney South West Area Health Service (SSWAHS and follow up will occur over 12 months. SEISMIC will use the International League Against Epilepsy (ILAE definitions and classifications for epidemiologic studies of epilepsy. The study will examine outcomes including mood, quality of life, employment, education performance, driving status, marital and social problems, medication use, health care usage, costs and stigma. Discussion This study is designed to examine how clinical, psychological factors, socioeconomic circumstances, and healthcare delivery influence the experience of epilepsy for individuals and families allowing better targeting of specific services and informing policy makers and practitioners. In addition, the study will provide the basis for a longitudinal population-based cohort study and potentially inform qualitative sub-studies and randomised controlled trials of intervention strategies. The study has

  4. Cryptographic Protocols:

    DEFF Research Database (Denmark)

    Geisler, Martin Joakim Bittel

    implemented the comparison protocol in Java and benchmarks show that is it highly competitive and practical. The biggest contribution of this dissertation is a general framework for secure multiparty computation. Instead of making new ad hoc implementations for each protocol, we want a single and extensible...... real-world cases, a large probability of being caught is sufficient to prevent the adversary from trying to cheat. We show how to compile a passively secure protocol for honest majority into a protocol that is secure against covert attacks, again for honest majority. The transformed protocol catches...... cheating with probability 1/4 . Though we present no implementation of this compiler, we believe it will be very efficient and practical to implement using, say, VIFF. The cost of the modified protocol is essentially twice that of the original plus an overhead that only depends on the number of inputs. We...

  5. Right Iliac Fossa Pain Treatment (RIFT) Study: protocol for an international, multicentre, prospective observational study.

    Science.gov (United States)

    2018-01-13

    Patients presenting with right iliac fossa (RIF) pain are a common challenge for acute general surgical services. Given the range of potential pathologies, RIF pain creates diagnostic uncertainty and there is subsequent variation in investigation and management. Appendicitis is a diagnosis which must be considered in all patients with RIF pain; however, over a fifth of patients undergoing appendicectomy, in the UK, have been proven to have a histologically normal appendix (negative appendicectomy). The primary aim of this study is to determine the contemporary negative appendicectomy rate. The study's secondary aims are to determine the rate of laparoscopy for appendicitis and to validate the Appendicitis Inflammatory Response (AIR) and Alvarado prediction scores. This multicentre, international prospective observational study will include all patients referred to surgical specialists with either RIF pain or suspected appendicitis. Consecutive patients presenting within 2-week long data collection periods will be included. Centres will be invited to participate in up to four data collection periods between February and August 2017. Data will be captured using a secure online data management system. A centre survey will profile local policy and service delivery for management of RIF pain. Research ethics are not required for this study in the UK, as determined using the National Research Ethics Service decision tool. This study will be registered as a clinical audit in participating UK centres. National leads in countries outside the UK will oversee appropriate registration and study approval, which may include completing full ethical review. The study will be disseminated by trainee-led research collaboratives and through social media. Peer-reviewed publications will be published under corporate authorship including 'RIFT Study Group' and 'West Midlands Research Collaborative'. © Article author(s) (or their employer(s) unless otherwise stated in the text of the

  6. Impact of SciELO and MEDLINE indexing on submissions to Jornal de Pediatria.

    Science.gov (United States)

    Blank, Danilo; Buchweitz, Claudia; Procianoy, Renato S

    2005-01-01

    To evaluate the impact of SciELO and MEDLINE indexing on the number of articles submitted to Jornal de Pediatria. Analysis of total article submission, submission of articles from foreign countries and acceptance figures in the following periods: stage I - pre-website (Jan 2000-Mar 2001); stage II - website (Apr 2001-Jul 2002); stage III - SciELO (Aug 2002-Aug 2003); stage IV - MEDLINE (Sep 2003-Dec 2004). There was a significant trend toward linear increase in the number of submissions along the study period (p = 0.009). The number of manuscripts submitted in stages I through IV was 184, 240, 297, and 482, respectively. The number of submissions was similar in stages I and II (p = 0.148), but statistically higher in Stage III (p Pediatria, whereas MEDLINE indexing led to an increase in both Brazilian and foreign submissions.

  7. Study and Analysis of the Internet Protocol Security and Its Impact on Interactive Communications

    Science.gov (United States)

    Khan, Arshi; Ansari, Seema

    Internet Protocol Security (IPSec) is the defacto standard, which offers secured Internet communications, providing traffic integrity, confidentiality and authentication. Besides this, it is assumed that IPSec is not suitable for the protection of realtime audio transmissions as the IPSec related enlargement of packets and the usage of the Cipher Block Chaining (CBC) mode contradict stringent requirements. IPSec overhead of at least 44 bytes for each Internet Protocol (IP)-packet cannot guarantee Quality of Service (QOS) due to a bad wireless link by which the Ethernet flow control intercepts and makes a real time transmission impossible.

  8. Outcomes of usual chiropractic, harm & efficacy, the ouch study: study protocol for a randomized controlled trial

    Science.gov (United States)

    2011-01-01

    Background Previous studies have demonstrated that adverse events occur during chiropractic treatment. However, because of these studies design we do not know the frequency and extent of these events when compared to sham treatment. The principal aims of this study are to establish the frequency and severity of adverse effects from short term usual chiropractic treatment of the spine when compared to a sham treatment group. The secondary aim of this study is to establish the efficacy of usual short term chiropractic care for spinal pain when compared to a sham intervention. Methods One hundred and eighty participants will be randomly allocated to either usual chiropractic care or a sham intervention group. To be considered for inclusion the participants must have experienced non-specific spinal pain for at least one week. The study will be conducted at the clinics of registered chiropractors in Western Australia. Participants in each group will receive two treatments at intervals no less than one week. For the usual chiropractic care group, the selection of therapeutic techniques will be left to the chiropractors' discretion. For the sham intervention group, de-tuned ultrasound and de-tuned activator treatment will be applied by the chiropractors to the regions where spinal pain is experienced. Adverse events will be assessed two days after each appointment using a questionnaire developed for this study. The efficacy of short term chiropractic care for spinal pain will be examined at two week follow-up by assessing pain, physical function, minimum acceptable outcome, and satisfaction with care, with the use of the following outcome measures: Numerical Rating Scale, Functional Rating Index, Neck Disability Index, Minimum Acceptable Outcome Questionnaire, Oswestry Disability Index, and a global measure of treatment satisfaction. The statistician, outcome assessor, and participants will be blinded to treatment allocation. Trial registration Australia and New Zealand

  9. Outcomes of usual chiropractic, harm & efficacy, the ouch study: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Walker Bruce F

    2011-10-01

    Full Text Available Abstract Background Previous studies have demonstrated that adverse events occur during chiropractic treatment. However, because of these studies design we do not know the frequency and extent of these events when compared to sham treatment. The principal aims of this study are to establish the frequency and severity of adverse effects from short term usual chiropractic treatment of the spine when compared to a sham treatment group. The secondary aim of this study is to establish the efficacy of usual short term chiropractic care for spinal pain when compared to a sham intervention. Methods One hundred and eighty participants will be randomly allocated to either usual chiropractic care or a sham intervention group. To be considered for inclusion the participants must have experienced non-specific spinal pain for at least one week. The study will be conducted at the clinics of registered chiropractors in Western Australia. Participants in each group will receive two treatments at intervals no less than one week. For the usual chiropractic care group, the selection of therapeutic techniques will be left to the chiropractors' discretion. For the sham intervention group, de-tuned ultrasound and de-tuned activator treatment will be applied by the chiropractors to the regions where spinal pain is experienced. Adverse events will be assessed two days after each appointment using a questionnaire developed for this study. The efficacy of short term chiropractic care for spinal pain will be examined at two week follow-up by assessing pain, physical function, minimum acceptable outcome, and satisfaction with care, with the use of the following outcome measures: Numerical Rating Scale, Functional Rating Index, Neck Disability Index, Minimum Acceptable Outcome Questionnaire, Oswestry Disability Index, and a global measure of treatment satisfaction. The statistician, outcome assessor, and participants will be blinded to treatment allocation. Trial

  10. Automated control of mechanical ventilation during general anaesthesia: study protocol of a bicentric observational study (AVAS).

    Science.gov (United States)

    Schädler, Dirk; Miestinger, Georg; Becher, Tobias; Frerichs, Inéz; Weiler, Norbert; Hörmann, Christoph

    2017-05-10

    Automated control of mechanical ventilation during general anaesthesia is not common. A novel system for automated control of most of the ventilator settings was designed and is available on an anaesthesia machine. The 'Automated control of mechanical ventilation during general anesthesia study' (AVAS) is an international investigator-initiated bicentric observational study designed to examine safety and efficacy of the system during general anaesthesia. The system controls mechanical breathing frequency, inspiratory pressure, pressure support, inspiratory time and trigger sensitivity with the aim to keep a patient stable in user adoptable target zones. Adult patients, who are classified as American Society of Anesthesiologists physical status I, II or III, scheduled for elective surgery of the upper or lower limb or for peripheral vascular surgery in general anaesthesia without any additional regional anaesthesia technique and who gave written consent for study participation are eligible for study inclusion. Primary endpoint of the study is the frequency of specifically defined adverse events. Secondary endpoints are frequency of normoventilation, hypoventilation and hyperventilation, the time period between switch from controlled ventilation to assisted ventilation, achievement of stable assisted ventilation of the patient, proportion of time within the target zone for tidal volume, end-tidal partial pressure of carbon dioxide as individually set up for each patient by the user, frequency of alarms, frequency distribution of tidal volume, inspiratory pressure, inspiration time, expiration time, end-tidal partial pressure of carbon dioxide and the number of re-intubations. AVAS will be the first clinical study investigating a novel automated system for the control of mechanical ventilation on an anaesthesia machine. The study was approved by the ethics committees of both participating study sites. In case that safety and efficacy are acceptable, a randomised

  11. Vitamin D supplementation in the management of knee osteoarthritis: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Cao Yuelong

    2012-08-01

    Full Text Available Abstract Background Osteoarthritis (OA is a common health issue worldwide in the aging population who are also commonly deficient in vitamin D. Our previous study suggested that higher serum 25-(OHD levels were associated with reduced knee cartilage loss, implying that vitamin D supplementation may prevent the progression of knee OA. The aim of the VItamin D Effects on OA (VIDEO study is to compare, over a 2- year period, the effects of vitamin D supplementation versus placebo on knee structural changes, knee pain, and lower limb muscle strength in patients with symptomatic knee OA. Methods/design Randomised, placebo-controlled, and double-blind clinical trial aiming to recruit 400 subjects (200 from Tasmania and 200 from Victoria with both symptomatic knee OA and vitamin D deficiency (serum [25-(OHD] level of >12.5 nmol/liter and 3 capsule monthly or identical inert placebo group for 2 years. The primary endpoint is loss of knee cartilage volume measured by magnetic resonance imaging (MRI and Western Ontario and McMaster Universities Index of OA (WOMAC knee pain score. The secondary endpoints will be other knee structural changes, and lower limb muscle strength. Several other outcome measures including core muscle images and central blood pressure will be recorded. Linear and logistic regression will be used to compare changes between groups using univariable and multivariable modeling analyses. Both intention to treat and per protocol analyses will be utilized. Discussion The trial is designed to test if vitamin D supplementation will reduce loss of knee cartilage volume, prevent the progression of other knee structural abnormalities, reduce knee pain and strengthen lower limb muscle strength, thus modify disease progression in knee OA. Trial registration ClinicalTrials.gov identifier: NCT01176344; Australian New Zealand Clinical Trials Registry: ACTRN12610000495022

  12. Vitamin D supplementation in the management of knee osteoarthritis: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Cao, Yuelong; Jones, Graeme; Cicuttini, Flavia; Winzenberg, Tania; Wluka, Anita; Sharman, James; Nguo, Kay; Ding, Changhai

    2012-08-06

    Osteoarthritis (OA) is a common health issue worldwide in the aging population who are also commonly deficient in vitamin D. Our previous study suggested that higher serum 25-(OH)D levels were associated with reduced knee cartilage loss, implying that vitamin D supplementation may prevent the progression of knee OA. The aim of the VItamin D Effects on OA (VIDEO) study is to compare, over a 2- year period, the effects of vitamin D supplementation versus placebo on knee structural changes, knee pain, and lower limb muscle strength in patients with symptomatic knee OA. Randomised, placebo-controlled, and double-blind clinical trial aiming to recruit 400 subjects (200 from Tasmania and 200 from Victoria) with both symptomatic knee OA and vitamin D deficiency (serum [25-(OH)D] level of >12.5 nmol/liter and vitamin D supplementation (50,000 IU compounded vitamin D3 capsule monthly) or identical inert placebo group for 2 years. The primary endpoint is loss of knee cartilage volume measured by magnetic resonance imaging (MRI) and Western Ontario and McMaster Universities Index of OA (WOMAC) knee pain score. The secondary endpoints will be other knee structural changes, and lower limb muscle strength. Several other outcome measures including core muscle images and central blood pressure will be recorded. Linear and logistic regression will be used to compare changes between groups using univariable and multivariable modeling analyses. Both intention to treat and per protocol analyses will be utilized. The trial is designed to test if vitamin D supplementation will reduce loss of knee cartilage volume, prevent the progression of other knee structural abnormalities, reduce knee pain and strengthen lower limb muscle strength, thus modify disease progression in knee OA. ClinicalTrials.gov identifier: NCT01176344; Australian New Zealand Clinical Trials Registry: ACTRN12610000495022.

  13. A randomised controlled trial linking mental health inpatients to community smoking cessation supports: A study protocol

    Directory of Open Access Journals (Sweden)

    Clancy Richard

    2011-07-01

    Full Text Available Abstract Background Mental health inpatients smoke at higher rates than the general population and are disproportionately affected by tobacco dependence. Despite the advent of smoke free policies within mental health hospitals, limited systems are in place to support a cessation attempt post hospitalisation, and international evidence suggests that most smokers return to pre-admission smoking levels following discharge. This protocol describes a randomised controlled trial that will test the feasibility, acceptability and efficacy of linking inpatient smoking care with ongoing community cessation support for smokers with a mental illness. Methods/Design This study will be conducted as a randomised controlled trial. 200 smokers with an acute mental illness will be recruited from a large inpatient mental health facility. Participants will complete a baseline survey and will be randomised to either a multimodal smoking cessation intervention or provided with hospital smoking care only. Randomisation will be stratified by diagnosis (psychotic, non-psychotic. Intervention participants will be provided with a brief motivational interview in the inpatient setting and options of ongoing smoking cessation support post discharge: nicotine replacement therapy (NRT; referral to Quitline; smoking cessation groups; and fortnightly telephone support. Outcome data, including cigarettes smoked per day, quit attempts, and self-reported 7-day point prevalence abstinence (validated by exhaled carbon monoxide, will be collected via blind interview at one week, two months, four months and six months post discharge. Process information will also be collected, including the use of cessation supports and cost of the intervention. Discussion This study will provide comprehensive data on the potential of an integrated, multimodal smoking cessation intervention for persons with an acute mental illness, linking inpatient with community cessation support. Trial Registration

  14. Multisite Semiautomated Clinical Data Repository for Duplication 15q Syndrome: Study Protocol and Early Uses.

    Science.gov (United States)

    Ajayi, Oluwaseun Jessica; Smith, Ebony Jeannae; Viangteeravat, Teeradache; Huang, Eunice Y; Nagisetty, Naga Satya V Rao; Urraca, Nora; Lusk, Laina; Finucane, Brenda; Arkilo, Dimitrios; Young, Jennifer; Jeste, Shafali; Thibert, Ronald; Reiter, Lawrence T

    2017-10-18

    Chromosome 15q11.2-q13.1 duplication syndrome (Dup15q syndrome) is a rare disorder caused by duplications of chromosome 15q11.2-q13.1, resulting in a wide range of developmental disabilities in affected individuals. The Dup15q Alliance is an organization that provides family support and promotes research to improve the quality of life of patients living with Dup15q syndrome. Because of the low prevalence of this condition, the establishment of a single research repository would have been difficult and more time consuming without collaboration across multiple institutions. The goal of this project is to establish a national deidentified database with clinical and survey information on individuals diagnosed with Dup15q syndrome. The development of a multiclinic site repository for clinical and survey data on individuals with Dup15q syndrome was initiated and supported by the Dup15q Alliance. Using collaborative workflows, communication protocols, and stakeholder engagement tools, a comprehensive database of patient-centered information was built. We successfully established a self-report populating, centralized repository for Dup15q syndrome research. This repository also resulted in the development of standardized instruments that can be used for other studies relating to developmental disorders. By standardizing the data collection instruments, it allows us integrate our data with other national databases, such as the National Database for Autism Research. A substantial portion of the data collected from the questionnaires was facilitated through direct engagement of participants and their families. This allowed for a more complete set of information to be collected with a minimal turnaround time. We developed a repository that can efficiently be mined for shared clinical phenotypes observed at multiple clinic sites and used as a springboard for future clinical and basic research studies.

  15. A bibliometric analysis of cancer research in South Africa: study protocol.

    Science.gov (United States)

    Moodley, Jennifer; Singh, Vedantha; Kagina, Benjamin M; Abdullahi, Leila; Hussey, Gregory D

    2015-02-12

    Cancer is an important and growing public health burden in South Africa (SA). Over the past few decades, there has been considerable scientific activity in cancer in SA. However, there has been limited analysis of cancer scientific publications. In this paper, we present a protocol for bibliometric analysis of cancer research conducted in SA. A comprehensive search of the journal databases PubMed, SCOPUS, Web of Science and EBSCO will be conducted to identify and retrieve data from primary peer-reviewed cancer research articles using a set of consensus search words. Articles that involve cancer research conducted in SA or using biological or clinical data from South African participants and published between 2004 and 2014 will be included in the study. Two independent researchers will screen the articles for eligibility. Bibliometric indicators and study characteristics will be extracted, entered into a database and analysed. The cancer disease site will be recorded and research will be classified using the Common Scientific Outline system. Data obtained will be analysed to determine SA's publication productivity index in cancer research. Annual trends in bibliometric indicators and the type of cancer research will be determined. The degree of collaboration in research conducted in SA will be analysed using co-authorship matrix software. A publication to disease type ratio will be used to assess scientific production relative to disease burden. As this analysis will draw on publicly available data and does not directly involve human participants, ethical review is not required. We anticipate that the bibliometric analysis will identify the trends in cancer research productivity and the extent to which cancer research is aligned to the local burden of disease. Results will be published in peer-reviewed journals and presented in a user-friendly format to relevant policymakers and funders. Published by the BMJ Publishing Group Limited. For permission to use (where not

  16. Use of a mobile social networking intervention for weight management: a mixed-methods study protocol.

    Science.gov (United States)

    Laranjo, Liliana; Lau, Annie Y S; Martin, Paige; Tong, Huong Ly; Coiera, Enrico

    2017-07-12

    Obesity and physical inactivity are major societal challenges and significant contributors to the global burden of disease and healthcare costs. Information and communication technologies are increasingly being used in interventions to promote behaviour change in diet and physical activity. In particular, social networking platforms seem promising for the delivery of weight control interventions.We intend to pilot test an intervention involving the use of a social networking mobile application and tracking devices (Fitbit Flex 2 and Fitbit Aria scale) to promote the social comparison of weight and physical activity, in order to evaluate whether mechanisms of social influence lead to changes in those outcomes over the course of the study. Mixed-methods study involving semi-structured interviews and a pre-post quasi-experimental pilot with one arm, where healthy participants in different body mass index (BMI) categories, aged between 19 and 35 years old, will be subjected to a social networking intervention over a 6-month period. The primary outcome is the average difference in weight before and after the intervention. Secondary outcomes include BMI, number of steps per day, engagement with the intervention, social support and system usability. Semi-structured interviews will assess participants' expectations and perceptions regarding the intervention. Ethics approval was granted by Macquarie University's Human Research Ethics Committee for Medical Sciences on 3 November 2016 (ethics reference number 5201600716).The social network will be moderated by a researcher with clinical expertise, who will monitor and respond to concerns raised by participants. Monitoring will involve daily observation of measures collected by the fitness tracker and the wireless scale, as well as continuous supervision of forum interactions and posts. Additionally, a protocol is in place to monitor for participant misbehaviour and direct participants-in-need to appropriate sources of help.

  17. The Healthy Primary School of the Future: study protocol of a quasi-experimental study

    NARCIS (Netherlands)

    Willeboordse, Maartje; Jansen, Maria; van den Heijkant, S.N.; Simons, Andrew; Winkens, B.; De Groot, Renate; Bartelink, Nina; Kremers, Stef; van Assema, Patricia; Savelberg, Hans; de Neubourg, E.; Borghans, Lex; Schils, T.; Coppens, K.M.; Dietvorst, R.; ten Hoopen, R.; Coomans, F.; Klosse, S.; Conjaerts, Martien; Oosterhoff, M.; Joore, Manuela; Ferreira, I.; Muris, P.; Bosma, Hans; Toppenberg, H.L.; van Schayck, Onno

    2017-01-01

    Background: Unhealthy lifestyles in early childhood are a major global health challenge. These lifestyles often persist from generation to generation and contribute to a vicious cycle of health-related and social problems. This design article presents a study evaluating the effects of two novel

  18. Train High Eat Low for Osteoarthritis study (THE LO study: protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Yareni Guerrero

    2015-10-01

    Discussion: THE LO study will provide the first direct comparison of the long-term benefits of gait retraining, progressive resistance training and a high-protein/low-glycaemic-index energy-restricted diet, separately and in combination, on joint load, radiographic progression, symptoms, and associated co-morbidities in overweight/obese adults with OA of the knee.

  19. Long Working Hours and Subsequent Use of Psychotropic Medicine: A Study Protocol

    Science.gov (United States)

    Albertsen, Karen

    2014-01-01

    Background Mental ill health is the most frequent cause of long-term sickness absence and disability retirement in Denmark. Some instances of mental ill health might be due to long working hours. A recent large cross-sectional study of a general working population in Norway found that not only “very much overtime”, but also “moderate overtime” (41-48 work hours/week) was significantly associated with increased levels of both anxiety and depression. These findings have not been sufficiently confirmed in longitudinal studies. Objective The objective of the study is to give a detailed plan for a research project aimed at investigating the possibility of a prospective association between weekly working hours and use of psychotropic medicine in the general working population of Denmark. Methods People from the general working population of Denmark have been surveyed, at various occasions in the time period 1995-2010, and interviewed about their work environment. The present study will link interview data from these surveys to national registers covering all inhabitants of Denmark. The participants will be followed for the first occurrence of redeemed prescriptions for psychotropic medicine. Poisson regression will be used to analyze incidence rates as a function of weekly working hours (32-40; 41-48; > 48 hours/week). The analyses will be controlled for gender, age, sample, shift work, and socioeconomic status. According to our feasibility studies, the statistical power is sufficient and the exposure is stable enough to make the study worth the while. Results The publication of the present study protocol ends the design phase of the project. In the next phase, the questionnaire data will be forwarded to Statistics Denmark where they will be linked to data on deaths, migrations, socioeconomic status, and redeemed prescriptions for psychotropic medication. We expect the analysis to be completed by the end of 2014 and the results to be published mid 2015

  20. Built Environment and Active Transport to School (BEATS) Study: protocol for a cross-sectional study.

    Science.gov (United States)

    Mandic, Sandra; Williams, John; Moore, Antoni; Hopkins, Debbie; Flaherty, Charlotte; Wilson, Gordon; García Bengoechea, Enrique; Spence, John C

    2016-05-24

    Active transport to school (ATS) is a convenient way to increase physical activity and undertake an environmentally sustainable travel practice. The Built Environment and Active Transport to School (BEATS) Study examines ATS in adolescents in Dunedin, New Zealand, using ecological models for active transport that account for individual, social, environmental and policy factors. The study objectives are to: (1) understand the reasons behind adolescents and their parents' choice of transport mode to school; (2) examine the interaction between the transport choices, built environment, physical activity and weight status in adolescents; and (3) identify policies that promote or hinder ATS in adolescents. The study will use a mixed-method approach incorporating both quantitative (surveys, anthropometry, accelerometers, Geographic Information System (GIS) analysis, mapping) and qualitative methods (focus groups, interviews) to gather data from students, parents, teachers and school principals. The core data will include accelerometer-measured physical activity, anthropometry, GIS measures of the built environment and the use of maps indicating route to school (students)/work (parents) and perceived safe/unsafe areas along the route. To provide comprehensive data for understanding how to change the infrastructure to support ATS, the study will also examine complementary variables such as individual, family and social factors, including student and parental perceptions of walking and cycling to school, parental perceptions of different modes of transport to school, perceptions of the neighbourhood environment, route to school (students)/work (parents), perceptions of driving, use of information communication technology, reasons for choosing a particular school and student and parental physical activity habits, screen time and weight status. The study has achieved a 100% school recruitment rate (12 secondary schools). The study has been approved by the University of Otago

  1. Cognitive Dysfunction Survey of the Japanese Patients with Moyamoya Disease (COSMO-JAPAN Study): study protocol.

    Science.gov (United States)

    Takagi, Yasushi; Miyamoto, Susumu

    2015-01-01

    Moyamoya disease is a cerebrovascular occlusive disease characterized by progressive stenosis or by occlusion at the terminal portion of the bilateral internal carotid arteries. The unusual vascular network (moyamoya vessels) at the base of the brain with this disease as collateral channels is developed in this disease. Social independence because of cognitive impairment has recently been recognized as an important unsolved social issue with adult moyamoya disease. The patients with cognitive impairment have difficulty in proving their status because the standard neuroradiological and neuropsychological methods to define cognitive impairment with moyamoya disease are not determined. These patients with cognitive impairment should be supported by social welfare as psychologically handicapped persons. Thus Cognitive Dysfunction Survey of the Japanese Patients with Moyamoya Disease (COSMO-JAPAN study) is planned. In this study, we want to establish a standard finding of the cognitive impairment in patients with moyamoya disease.

  2. A STUDY PROTOCOL ON COMMUNITY ACCEPTABILITY OF VEGETABLE OIL BLENDS WITH RED PALMOLEIN- A SEMIRANDOMIZED STUDY

    OpenAIRE

    Sankar, Uma V.; , Dr.Nisha.P2

    2017-01-01

    Vegetable oils are the rich source of vitamins and various essential fatty acids. The blending of the vegetable oils gave double benefit to health. Among the vegetable oils, red palm olein is the richest source of carotenoids and prevent the hyper cholesteremia. Prevalence of hyper cholesterolemia was 56.4% in Kerala. Availability and consumption of blended vegetable oil help to prevent the hyper cholesteremia in a way. In this study, we aimed to know the acceptability of the blended vegetabl...

  3. Ghana randomized air pollution and health study (GRAPHS): study protocol for a randomized controlled trial

    OpenAIRE

    Jack, Darby W.; Asante, Kwaku Poku; Blair J. Wylie; Chillrud, Steve N.; Whyatt, Robin M.; Ae-Ngibise, Kenneth A.; Quinn, Ashlinn K.; Yawson, Abena Konadu; Boamah, Ellen Abrafi; Agyei, Oscar; Mujtaba, Mohammed; Kaali, Seyram; Kinney, Patrick; Owusu-Agyei, Seth

    2015-01-01

    Background: Household air pollution exposure is a major health risk, but validated interventions remain elusive. Methods/Design The Ghana Randomized Air Pollution and Health Study (GRAPHS) is a cluster-randomized trial that evaluates the efficacy of clean fuels (liquefied petroleum gas, or LPG) and efficient biomass cookstoves in the Brong-Ahafo region of central Ghana. We recruit pregnant women into LPG, efficient cookstove, and control arms and track birth weight and physician-assessed seve...

  4. Study protocol title: a prospective cohort study of low back pain

    Science.gov (United States)

    2013-01-01

    Background Few prospective cohort studies of workplace low back pain (LBP) with quantified job physical exposure have been performed. There are few prospective epidemiological studies for LBP occupational risk factors and reported data generally have few adjustments for many personal and psychosocial factors. Methods/design A multi-center prospective cohort study has been incepted to quantify risk factors for LBP and potentially develop improved methods for designing and analyzing jobs. Due to the subjectivity of LBP, six measures of LBP are captured: 1) any LBP, 2) LBP ≥ 5/10 pain rating, 3) LBP with medication use, 4) LBP with healthcare provider visits, 5) LBP necessitating modified work duties and 6) LBP with lost work time. Workers have thus far been enrolled from 30 different employment settings in 4 diverse US states and performed widely varying work. At baseline, workers undergo laptop-administered questionnaires, structured interviews, and two standardized physical examinations to ascertain demographics, medical history, psychosocial factors, hobbies and physical activities, and current musculoskeletal disorders. All workers’ jobs are individually measured for physical factors and are videotaped. Workers are followed monthly for the development of low back pain. Changes in jobs necessitate re-measure and re-videotaping of job physical factors. The lifetime cumulative incidence of low back pain will also include those with a past history of low back pain. Incident cases will exclude prevalent cases at baseline. Statistical methods planned include survival analyses and logistic regression. Discussion Data analysis of a prospective cohort study of low back pain is underway and has successfully enrolled over 800 workers to date. PMID:23497211

  5. Advancing Survivors' Knowledge (ASK) about skin cancer study: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Daniel, Casey L; Armstrong, Gregory T; Keske, Robyn R; Davine, Jessica A; McDonald, Aaron J; Sprunck-Harrild, Kim M; Coleman, Catherine; Haneuse, Sebastien J; Mertens, Ann C; Emmons, Karen M; Marghoob, Ashfaq A; Elkin, Elena B; Dusza, Stephen W; Robison, Leslie L; Geller, Alan C

    2015-03-24

    Advances in treatment have increased childhood cancer 5-year survival rates to greater than 80%. However, children previously treated with radiation are at significantly increased risk of developing subsequent neoplasms, the most common of which are skin cancers. The National Cancer Institute and Children's Oncology Group have issued recommendations for survivors treated with radiation to perform monthly skin self-examinations and receive a physician skin examination at least annually, as early detection has demonstrated markedly improved outcomes in the diagnosis and treatment of skin cancers. The goal of the present study is to increase rates of skin self-examinations and clinical skin examinations among adult survivors of childhood cancer treated with radiation. This randomized controlled trial uses a 3-group comparative effectiveness design comparing: (1) Patient Activation and Education (PAE) including text messaging, print and web-based tutorials over 12 months; (2) PAE plus physician activation (PAE + MD) adding physician activation/educational materials about survivors' increased skin cancer risk and conducting full-body skin exams; and (3) PAE plus physician activation, plus teledermoscopy (PAE + MD + TD) adding participant receipt of a dermatoscope intended to empower them to photograph suspect moles or lesions for review by the study dermatologist. The current study addresses barriers to screening in this population by providing educational and motivational information for both survivors and physicians regarding the value of periodic skin examinations. It also utilizes innovative mobile health technology to encourage and motivate (that is activate) survivors to conduct skin self-examinations, request physician exams, and obtain treatment when worrisome lesions are found. Finally, as a comparative effectiveness trial, this study isolates the effects of adding specific components to the patient activation intervention to test the most effective

  6. Aspirin in venous leg ulcer study (ASPiVLU): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Weller, Carolina D; Barker, Anna; Darby, Ian; Haines, Terrence; Underwood, Martin; Ward, Stephanie; Aldons, Pat; Dapiran, Elizabeth; Madan, Jason J; Loveland, Paula; Sinha, Sankar; Vicaretti, Mauro; Wolfe, Rory; Woodward, Michael; McNeil, John

    2016-04-11

    Venous leg ulceration is a common and costly problem that is expected to worsen as the population ages. Current treatment is compression therapy; however, up to 50 % of ulcers remain unhealed after 2 years, and ulcer recurrence is common. New treatments are needed to address those wounds that are more challenging to heal. Targeting the inflammatory processes present in venous ulcers is a possible strategy. Limited evidence suggests that a daily dose of aspirin may be an effective adjunct to aid ulcer healing and reduce recurrence. The Aspirin in Venous Leg Ulcer study (ASPiVLU) will investigate whether 300-mg oral doses of aspirin improve time to healing. This randomised, double-blinded, multicentre, placebo-controlled, clinical trial will recruit participants with venous leg ulcers from community settings and hospital outpatient wound clinics across Australia. Two hundred sixty-eight participants with venous leg ulcers will be randomised to receive either aspirin or placebo, in addition to compression therapy, for 24 weeks. The primary outcome is time to healing within 12 weeks. Secondary outcomes are ulcer recurrence, wound pain, quality of life and wellbeing, adherence to study medication, adherence to compression therapy, serum inflammatory markers, hospitalisations, and adverse events at 24 weeks. The ASPiVLU trial will investigate the efficacy and safety of aspirin as an adjunct to compression therapy to treat venous leg ulcers. Study completion is anticipated to occur in December 2018. Australian New Zealand Clinical Trials Registry, ACTRN12614000293662.

  7. Midlife women, bone health, vegetables, herbs and fruit study. The Scarborough Fair study protocol.

    Science.gov (United States)

    Gunn, Caroline A; Weber, Janet L; Kruger, Marlena C

    2013-01-10

    Bone loss is accelerated in middle aged women but increased fruit/vegetable intake positively affects bone health by provision of micronutrients essential for bone formation, buffer precursors which reduce acid load and phytochemicals affecting inflammation and oxidative stress. Animal studies demonstrated bone resorption inhibiting properties of specific vegetables, fruit and herbs a decade ago. To increase fruit/vegetable intake in post menopausal women to 9 servings/day using a food specific approach to significantly reduce dietary acid load and include specific vegetables, fruit and herbs with bone resorbing inhibiting properties to assess effect on bone turnover, metabolic and inflammatory markers. The Scarborough Fair Study is a randomised active comparator controlled multi centre trial. It aimed to increase fruit and vegetable intake in 100 post menopausal women from ≤ 5 servings/day to ≥ 9 servings/day for 3 months. The women in the dietary intervention were randomly assigned to one of the two arms of the study. Both groups consumed ≥ 9 servings/day of fruit/vegetables and selected herbs but the diet of each group emphasised different fruit/vegetables/herbs with one group (B) selecting from a range of vegetables, fruit and culinary herbs with bone resorbing inhibiting properties. 50 women formed a negative control group (Group C usual diet). Primary outcome variables were plasma bone markers assessed at baseline, 6 weeks and 12 weeks. Secondary outcome variables were plasma inflammation and metabolic markers and urinary electrolytes (calcium, magnesium, potassium and sodium) assessed at baseline and 12 weeks. Dietary intake and urine pH change also were outcome variables. The dietary change was calculated with 3 day diet diaries and a 24 hour recall. Intervention participants kept a twice weekly record of fruit, vegetable and herb intake and urine pH. This study will provide information on midlife women's bone health and how a dietary intervention

  8. SALGOT - Stroke Arm Longitudinal study at the University of Gothenburg, prospective cohort study protocol

    Directory of Open Access Journals (Sweden)

    Lundgren-Nilsson Åsa

    2011-05-01

    Full Text Available Abstract Background Recovery patterns of upper extremity motor function have been described in several longitudinal studies, but most of these studies have had selected samples, short follow up times or insufficient outcomes on motor function. The general understanding is that improvements in upper extremity occur mainly during the first month after the stroke incident and little if any, significant recovery can be gained after 3-6 months. The purpose of this study is to describe the recovery of upper extremity function longitudinally in a non-selected sample initially admitted to a stroke unit with first ever stroke, living in Gothenburg urban area. Methods/Design A sample of 120 participants with a first-ever stroke and impaired upper extremity function will be consecutively included from an acute stroke unit and followed longitudinally for one year. Assessments are performed at eight occasions: at day 3 and 10, week 3, 4 and 6, month 3, 6 and 12 after onset of stroke. The primary clinical outcome measures are Action Research Arm Test and Fugl-Meyer Assessment for Upper Extremity. As additional measures, two new computer based objective methods with kinematic analysis of arm movements are used. The ABILHAND questionnaire of manual ability, Stroke Impact Scale, grip strength, spasticity, pain, passive range of motion and cognitive function will be assessed as well. At one year follow up, two patient reported outcomes, Impact on Participation and Autonomy and EuroQol Quality of Life Scale, will be added to cover the status of participation and aspects of health related quality of life. Discussion This study comprises a non-selected population with first ever stroke and impaired arm function. Measurements are performed both using traditional clinical assessments as well as computer based measurement systems providing objective kinematic data. The ICF classification of functioning, disability and health is used as framework for the selection of

  9. European active surveillance study of women taking HRT (EURAS-HRT: study protocol [NCT00214903

    Directory of Open Access Journals (Sweden)

    Heinemann Lothar AJ

    2006-01-01

    Full Text Available Abstract Background The post marketing safety surveillance program for a drug containing a new chemical entity should assess both, the safety outcomes that relate specifically to the targeted population, as well as those that could potentially be related to special pharmacological characteristics of the drug. Active safety surveillance using valid epidemiological study designs has been proven to be a pertinent and reliable method to approach this endeavor. Methods/design The primary objective of the study is to compare incidence rates of serious adverse events in users of all types of newly prescribed oral HRT products. This active surveillance study will assess pertinent cardiovascular outcomes - in particular venous and arterial thromboembolism - and other serious adverse events (SAEs in new HRT users over a period of several years. One product under surveillance is Angeliq®, which contains the novel progestagen drospirenone (DRSP combined with estradiol. In addition, all other oral combined HRT products with a novel progestagen or estrogen that will be newly marketed during the study period will be studied. These new HRT products will be compared with established HRT products. The combined cohort will include at least 30,000 women recruited in several European countries. At least 90,000 years of observation are expected from the field work which started in early 2002 and will end around 2008. The participating women will complete a baseline survey using a self-administered questionnaire to describe the baseline risk. After 6 months, 12 months, and then on an annual basis, they will fill out a questionnaire in which they record complaints and events during the use of the prescribed HRTs. All adverse outcomes occurring during the observational period will be evaluated. Discussion A complete lifetime medical history, individually validated SAEs over time, and a low loss to follow-up rate are essential for a robust safety assessment. Therefore

  10. New predictive model for microsurgical outcome of intracranial arteriovenous malformations: study protocol.

    Science.gov (United States)

    Tong, Xianzeng; Wu, Jun; Cao, Yong; Zhao, Yuanli; Wang, Shuo

    2017-01-27

    Although microsurgical resection is currently the first-line treatment modality for arteriovenous malformations (AVMs), microsurgery of these lesions is complicated due to the fact that they are very heterogeneous vascular anomalies. The Spetzler-Martin grading system and the supplementary grading system have demonstrated excellent performances in predicting the risk of AVM surgery. However, there are currently no predictive models based on multimodal MRI techniques. The purpose of this study is to propose a predictive model based on multimodal MRI techniques to assess the microsurgical risk of intracranial AVMs. The study consists of 2 parts: the first part is to conduct a single-centre retrospective analysis of 201 eligible patients to create a predictive model of AVM surgery based on multimodal functional MRIs (fMRIs); the second part is to validate the efficacy of the predictive model in a prospective multicentre cohort study of 400 eligible patients. Patient characteristics, AVM features and multimodal fMRI data will be collected. The functional status at pretreatment and 6 months after surgery will be analysed using the modified Rankin Scale (mRS) score. The patients in each part of this study will be dichotomised into 2 groups: those with improved or unchanged functional status (a decreased or unchanged mRS 6 months after surgery) and those with worsened functional status (an increased mRS). The first part will determine the risk factors of worsened functional status after surgery and create a predictive model. The second part will validate the predictive model and then a new AVM grading system will be proposed. The study protocol and informed consent form have been reviewed and approved by the Institutional Review Board of Beijing Tiantan Hospital Affiliated to Capital Medical University (KY2016-031-01). The results of this study will be disseminated through printed media. NCT02868008. Published by the BMJ Publishing Group Limited. For permission to use

  11. Protocol of the COSMIN study: COnsensus-based Standards for the selection of health Measurement INstruments

    Directory of Open Access Journals (Sweden)

    Patrick DL

    2006-01-01

    Full Text Available Abstract Background Choosing an adequate measurement instrument depends on the proposed use of the instrument, the concept to be measured, the measurement properties (e.g. internal consistency, reproducibility, content and construct validity, responsiveness, and interpretability, the requirements, the burden for subjects, and costs of the available instruments. As far as measurement properties are concerned, there are no sufficiently specific standards for the evaluation of measurement properties of instruments to measure health status, and also no explicit criteria for what constitutes good measurement properties. In this paper we describe the protocol for the COSMIN study, the objective of which is to develop a checklist that contains COnsensus-based Standards for the selection of health Measurement INstruments, including explicit criteria for satisfying these standards. We will focus on evaluative health related patient-reported outcomes (HR-PROs, i.e. patient-reported health measurement instruments used in a longitudinal design as an outcome measure, excluding health care related PROs, such as satisfaction with care or adherence. The COSMIN standards will be made available in the form of an easily applicable checklist. Method An international Delphi study will be performed to reach consensus on which and how measurement properties should be assessed, and on criteria for good measurement properties. Two sources of input will be used for the Delphi study: (1 a systematic review of properties, standards and criteria of measurement properties found in systematic reviews of measurement instruments, and (2 an additional literature search of methodological articles presenting a comprehensive checklist of standards and criteria. The Delphi study will consist of four (written Delphi rounds, with approximately 30 expert panel members with different backgrounds in clinical medicine, biostatistics, psychology, and epidemiology. The final checklist will

  12. The Study of Environment on Aboriginal Resilience and Child Health (SEARCH: study protocol

    Directory of Open Access Journals (Sweden)

    2010-05-01

    Full Text Available Abstract Background Aboriginal Australians have a life expectancy more than ten years less than that of non-Aboriginal Australians, reflecting their disproportionate burden of both communicable and non-communicable disease throughout the lifespan. Little is known about the health and health trajectories of Aboriginal children and, although the majority of Aboriginal people live in urban areas, data are particularly sparse in relation to children living in urban areas. Methods/Design The Study of Environment on Aboriginal Resilience and Child Health (SEARCH is a cohort study of Aboriginal children aged 0-17 years, from urban and large regional centers in New South Wales, Australia. SEARCH focuses on Aboriginal community identified health priorities of: injury; otitis media; vaccine-preventable conditions; mental health problems; developmental delay; obesity; and risk factors for chronic disease. Parents/caregivers and their children are invited to participate in SEARCH at the time of presentation to one of the four participating Aboriginal Community Controlled Health Organisations at Mount Druitt, Campbelltown, Wagga Wagga and Newcastle. Questionnaire data are obtained from parents/caregivers and children, along with signed permission for follow-up through repeat data collection and data linkage. All children have their height, weight, waist circumference and blood pressure measured and complete audiometry, otoscopy/pneumatic otoscopy and tympanometry. Children aged 1-7 years have speech and language assessed and their parents/caregivers complete the Parental Evaluation of Developmental Status. The Study aims to recruit 1700 children by the end of 2010 and to secure resources for long term follow up. From November 2008 to March 2010, 1010 children had joined the study. From those 446 children with complete data entry, participating children ranged in age from 2 weeks to 17 years old, with 144 aged 0-3, 147 aged 4-7, 75 aged 8-10 and 79 aged 11

  13. The Newfoundland and Labrador Bariatric Surgery Cohort Study: Rational and Study Protocol

    Directory of Open Access Journals (Sweden)

    Laurie K. Twells

    2016-10-01

    Full Text Available Abstract Background In Canada, there has been a disproportionate increase in adults with Class II (BMI 35.0–39.9 kg/m2 or Class III obesity (BMI ≥ 40 kg/m2 affecting 9 % of Canadians with increases projected. Individuals affected by severe obesity (BMI ≥ 35 are at increased risk of high blood pressure, cardiovascular disease, diabetes, cancer, impaired quality of life, and premature mortality. Bariatric surgery is the most effective treatment for severe obesity. Laparoscopic sleeve gastrectomy (LSG, a relatively new type of bariatric surgery, is growing in popularity as a treatment. The global prevalence of LSG increased from 0 to 37.0 % between 2003 and 2013. In Canada and the US, between 2011 and 2013, the number of LSG surgeries increased by 244 % and LSG now comprises 43 % of all bariatric surgeries. Since 2011, Eastern Health, the largest regional health authority in Newfoundland and Labrador (NL, Canada has performed approximately 100 LSG surgeries annually. Methods A population-based prospective cohort study with pre and post surgical assessments at 1, 3, 6, 12, 18, 24 months and annually thereafter of patients undergoing LSG. This study will report on short - to mid-term (2–4 years outcomes. Patients (n = 200 followed by the Provincial Bariatric Surgery Program between 19 and 70 years of age, with a BMI between 35.0 and 39.9 kg/m2 and an obesity-related comorbidity or with a BMI ≥ 40 kg/m2 are enrolled. The study is assessing the following outcomes: 1 complications of surgery including impact on nutritional status 2 weight loss/regain 3 improvement/resolution of comorbid conditions and a reduction in prescribed medications 4 patient reported outcomes using validated quality of life tools, and 5 impact of surgery on health services use and costs. We hypothesize a low complication rate, a marked reduction in weight, improvement/resolution of comorbid conditions, a reduction in related medications

  14. The Newfoundland and Labrador Bariatric Surgery Cohort Study: Rational and Study Protocol.

    Science.gov (United States)

    Twells, Laurie K; Gregory, Deborah M; Midodzi, William K; Dillon, Carla; Kovacs, Christopher S; MacDonald, Don; Lester, Kendra K; Pace, David; Smith, Chris; Boone, Darrell; Murphy, Raleen

    2016-10-28

    In Canada, there has been a disproportionate increase in adults with Class II (BMI 35.0-39.9 kg/m2) or Class III obesity (BMI ≥ 40 kg/m2) affecting 9 % of Canadians with increases projected. Individuals affected by severe obesity (BMI ≥ 35) are at increased risk of high blood pressure, cardiovascular disease, diabetes, cancer, impaired quality of life, and premature mortality. Bariatric surgery is the most effective treatment for severe obesity. Laparoscopic sleeve gastrectomy (LSG), a relatively new type of bariatric surgery, is growing in popularity as a treatment. The global prevalence of LSG increased from 0 to 37.0 % between 2003 and 2013. In Canada and the US, between 2011 and 2013, the number of LSG surgeries increased by 244 % and LSG now comprises 43 % of all bariatric surgeries. Since 2011, Eastern Health, the largest regional health authority in Newfoundland and Labrador (NL), Canada has performed approximately 100 LSG surgeries annually. A population-based prospective cohort study with pre and post surgical assessments at 1, 3, 6, 12, 18, 24 months and annually thereafter of patients undergoing LSG. This study will report on short - to mid-term (2-4 years) outcomes. Patients (n = 200) followed by the Provincial Bariatric Surgery Program between 19 and 70 years of age, with a BMI between 35.0 and 39.9 kg/m2 and an obesity-related comorbidity or with a BMI ≥ 40 kg/m2 are enrolled. The study is assessing the following outcomes: 1) complications of surgery including impact on nutritional status 2) weight loss/regain 3) improvement/resolution of comorbid conditions and a reduction in prescribed medications 4) patient reported outcomes using validated quality of life tools, and 5) impact of surgery on health services use and costs. We hypothesize a low complication rate, a marked reduction in weight, improvement/resolution of comorbid conditions, a reduction in related medications, improvement in quality of life, and a

  15. The Bipolar Illness Onset study: research protocol for the BIO cohort study.

    Science.gov (United States)

    Kessing, Lars Vedel; Munkholm, Klaus; Faurholt-Jepsen, Maria; Miskowiak, Kamilla Woznica; Nielsen, Lars Bo; Frikke-Schmidt, Ruth; Ekstrøm, Claus; Winther, Ole; Pedersen, Bente Klarlund; Poulsen, Henrik Enghusen; McIntyre, Roger S; Kapczinski, Flavio; Gattaz, Wagner F; Bardram, Jakob; Frost, Mads; Mayora, Oscar; Knudsen, Gitte Moos; Phillips, Mary; Vinberg, Maj

    2017-06-23

    Bipolar disorder is an often disabling mental illness with a lifetime prevalence of 1%-2%, a high risk of recurrence of manic and depressive episodes, a lifelong elevated risk of suicide and a substantial heritability. The course of illness is frequently characterised by progressive shortening of interepisode intervals with each recurrence and increasing cognitive dysfunction in a subset of individuals with this condition. Clinically, diagnostic boundaries between bipolar disorder and other psychiatric disorders such as unipolar depression are unclear although pharmacological and psychological treatment strategies differ substantially. Patients with bipolar disorder are often misdiagnosed and the mean delay between onset and diagnosis is 5-10 years. Although the risk of relapse of depression and mania is high it is for most patients impossible to predict and consequently prevent upcoming episodes in an individual tailored way. The identification of objective biomarkers can both inform bipolar disorder diagnosis and provide biological targets for the development of new and personalised treatments. Accurate diagnosis of bipolar disorder in its early stages could help prevent the long-term detrimental effects of the illness.The present Bipolar Illness Onset study aims to identify (1) a composite blood-based biomarker, (2) a composite electronic smartphone-based biomarker and (3) a neurocognitive and neuroimaging-based signature for bipolar disorder. The study will include 300 patients with newly diagnosed/first-episode bipolar disorder, 200 of their healthy siblings or offspring and 100 healthy individuals without a family history of affective disorder. All participants will be followed longitudinally with repeated blood samples and other biological tissues, self-monitored and automatically generated smartphone data, neuropsychological tests and a subset of the cohort with neuroimaging during a 5 to 10-year study period. The study has been approved by the Local

  16. The Shared Health Appointments and Reciprocal Enhanced Support (SHARES) study: study protocol for a randomized trial.

    Science.gov (United States)

    Heisler, Michele; Burgess, Jennifer; Cass, Jeffrey; Chardos, John F; Guirguis, Alexander B; Jeffery, Sean M; Strohecker, Lorrie A; Tremblay, Adam S; Wu, Wen-Chih; Zulman, Donna M

    2017-05-26

    Diabetes shared medical appointments (SMAs) and reciprocal peer support programs have been found in efficacy trials to help adults with diabetes improve their self-management and achieve short-term gains in clinical and patient-centered outcomes. In order to translate this evidence to system-level interventions, there is a need for large-scale, pragmatic trials that examine the effectiveness, implementation, and costs of SMAs and reciprocal peer support across diverse settings. The Shared Health Appointments and Reciprocal Enhanced Support (SHARES) study is a multisite, cluster randomized trial that is evaluating the effectiveness and implementation of SMAs with and without an additional reciprocal Peer-to-Peer (P2P) support program, when compared to usual care. The P2P program comprises periodic peer support group sessions and telephone contact between SMA participant pairs to promote more effective diabetes self-management. We will examine outcomes across three different treatment groups: (1) SMAs, (2) SMAs plus P2P, and (3) usual care. We will collect and analyze data over a 2.5-year implementation period at five geographically diverse Veterans Affairs (VA) health systems. The primary outcome is the relative change in hemoglobin A1c over time. Secondary outcomes are changes in systolic blood pressure, antihypertensive medication use, statin use, and insulin initiation over the study period. The unit of analysis is the individual, adjusted by the individual's SMA group (the cluster). We will use mixed methods to rigorously evaluate processes and costs of implementing these programs in each of the clinic settings. We hypothesize that patients will experience improved outcomes immediately following participation in SMAs and that augmenting SMAs with reciprocal peer support will help to maintain these gains over time. The results of this study will be among the first to examine the effects of diabetes SMAs alone and in conjunction with P2P in a range of real

  17. Sentinel node in ovarian cancer: study protocol for a phase 1 study

    Directory of Open Access Journals (Sweden)

    Kleppe Marjolein

    2013-02-01

    Full Text Available Abstract Background The concept of sentinel lymph node surgery is to determine whether the cancer has spread to the very first lymph node or sentinel node. If the sentinel node does not contain cancer, then there is a high likelihood that the cancer has not spread to other lymph nodes. The sentinel node technique has been proven to be effective in different types of cancer. In this study we want to determine whether a sentinel node procedure in patients with ovarian cancer is feasible when the tracers are injected into the ovarian ligaments. Methods/Design Patients with a high likelihood of having an ovarian malignancy in whom a median laparotomy and a frozen section analysis is planned and patients with endometrial cancer in whom a staging laparotomy is planned will be included. Before starting the surgical staging procedure, blue dye and radioactive colloid will be injected into the ligamentum ovarii proprium and the ligamentum infundibulo-pelvicum. In the analysis we calculate the percentage of patients in whom it is feasible to identify sentinel nodes. Other study parameters are the anatomical localization of the sentinel node(s and the incidence of false negative lymph nodes. Trial registration Approval number: NL40323.068.12 Name: Medical Ethical Committee Maastricht University Hospital, University of Maastricht Affiliation: Maastricht University Hospital Board Chair Name: Medisch Ethische Commissie azM/UM

  18. Core Outcome Sets in Miscarriage Trials (COSMisT) study: a study protocol.

    Science.gov (United States)

    Smith, Paul; Cooper, Natalie; Dhillon-Smith, Rima; O'Toole, Emily; Clark, T Justin; Coomarasamy, Arri

    2017-11-16

    'Core outcome sets' are an agreed, standardised set of outcomes based on what key stakeholders (clinicians, patients, their partners, researchers, service developers, funding organisations and so on) consider the important outcomes in the management or prevention of a condition. This paper describes the rationale and design for the development of Core Outcome Sets for Miscarriage Trials. Systematic reviews, interviews and focus groups with patients and their partners will be conducted to identify potential core outcomes that will be introduced into a modified Delphi survey. To ensure all key stakeholders are included, patients, partners, clinicians, charities and researchers will be invited to take part in the modified Delphi survey. There will be three rounds of scoring and rescoring during the Delphi survey to reach consensus regarding outcomes to be included in the core set, which will be subsequently refined through face-to-face consensus discussions. The use of core outcome sets allows results from different studies to be compared and combined, thereby reducing inconsistency and aiding interpretation of study findings. It also means research is more likely to report relevant outcomes and so can reduce reporting bias. Understanding which outcomes are important to patients has the potential to act as a driver to improve both the quality and cost-effectiveness of miscarriage services. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  19. A comparative study of 'fast-track' versus traditional peri-operative care protocols in gastrointestinal surgeries.

    Science.gov (United States)

    Nanavati, Aditya J; Prabhakar, S

    2014-04-01

    A 'fast-track protocol' in surgery suggests the application of evidence-based practices to expedite patient recovery. It has shown to reduce hospital stay, hasten recovery as well as facilitate earlier return to work. It has a considerable impact in reducing healthcare costs. The basic tenet is to treat the patient's disease by minimal disturbance of their physiology. The protocol encompasses pre-operative, intra-operative and post-operative interventions which when carried out together would show maximal benefits. The surgeon is usually the leader of the team managing the patient, but it cannot be over-emphasised that this is a multi-disciplinary team approach. We conducted a prospective interventional study to investigate whether 'fast-track' surgery protocols improve patient outcome when compared to traditional peri-operative care followed at our institute. By doing so, we observed that the patients who underwent 'fast tracking' required lesser analgesia, had earlier ambulation, earlier return of intestinal motility, were free from tubes, catheters and drains earlier and lastly were discharged earlier. This was achieved without a rise in complications or re-admissions. The results have proved that implementing the fast-track protocol for gastrointestinal surgeries is not only safe and effective, but also improves patient outcome.

  20. State-space and verbal protocol methods for studying the human operator in process control.

    Science.gov (United States)

    Sanderson, Penelope M; Verhage, Alan G; Fuld, Robert B

    1989-11-01

    This paper presents a variety of methods founded in cognitive science for examining the behaviour of the human operator in process control. The waterbath task described by Crossman and Cooke (1974) and by Moray et al. (1986) is taken as a basic process control laboratory paradigm for applying these methods in an integrated approach. First, the waterbath task itself was analysed and a graphical representation developed to show relations between system variables (various valve and heater settings) and state variables (volume, temperature and flow rate). From this a representation of possible correct knowledge about the waterbath was developed. Second, a classification was made of the different states the waterbath system could be in with respect to an operator's goal state. A state-action diagram identified the correct control action or actions to travel from each state to the goal. This provided a basis for predicting the types of difficulties operators might have. Results of an experiment snowed that the need to coordinate several control actions to reach a goal was a source of difficulty. Subjects consistently misunderstood the relation between variables and performance data showed poorer performance when these variables had to be controlled. Verbal protocol data showed how often and how accurately subjects discussed particular aspects of the waterbath system. It was possible to piece together fragments of a subject's whole system of knowledge. Overall, the methods discussed contrast possible actions and knowledge with actual actions and knowledge. They represent a promising collection of data reduction techniques for studying the human operator in process control.

  1. MyVoice National Text Message Survey of Youth Aged 14 to 24 Years: Study Protocol.

    Science.gov (United States)

    DeJonckheere, Melissa; Nichols, Lauren P; Moniz, Michelle H; Sonneville, Kendrin R; Vydiswaran, V G Vinod; Zhao, Xinyan; Guetterman, Timothy C; Chang, Tammy

    2017-12-11

    There has been little progress in adolescent health outcomes in recent decades. Researchers and youth-serving organizations struggle to accurately elicit youth voice and translate youth perspectives into health care policy. Our aim is to describe the protocol of the MyVoice Project, a longitudinal mixed methods study designed to engage youth, particularly those not typically included in research. Text messaging surveys are collected, analyzed, and disseminated in real time to leverage youth perspectives to impact policy. Youth aged 14 to 24 years are recruited to receive weekly text message surveys on a variety of policy and health topics. The research team, including academic researchers, methodologists, and youth, develop questions through an iterative writing and piloting process. Question topics are elicited from community organizations, researchers, and policy makers to inform salient policies. A youth-centered interactive platform has been developed that automatically sends confidential weekly surveys and incentives to participants. Parental consent is not required because the survey is of minimal risk to participants. Recruitment occurs online (eg, Facebook, Instagram, university health research website) and in person at community events. Weekly surveys collect both quantitative and qualitative data. Quantitative data are analyzed using descriptive statistics. Qualitative data are quickly analyzed using natural language processing and traditional qualitative methods. Mixed methods integration and analysis supports a more in-depth understanding of the research questions. We are currently recruiting and enrolling participants through in-person and online strategies. Question development, weekly data collection, data analysis, and dissemination are in progress. MyVoice quickly ascertains the thoughts and opinions of youth in real time using a widespread, readily available technology-text messaging. Results are disseminated to researchers, policy makers, and

  2. Asparaginase-associated pancreatitis: a study on phenotype and genotype in the NOPHO ALL2008 protocol

    DEFF Research Database (Denmark)

    Wolthers, B. O.; Frandsen, Thomas L.; Abrahamsson, Jonas

    2016-01-01

    Asparaginase (ASP)-associated pancreatitis (AAP) occurs during acute lymphoblastic leukemia treatment. Among 1285 children (1.0-17.9 years) diagnosed during July 2008-December 2014 and treated according to the Nordic/Baltic ALL2008 protocol, 86 (cumulative incidence = 6.8%) developed AAP. Seventy...

  3. Protocol for Bone Augmentation with Simultaneous Early Implant Placement: A Retrospective Multicenter Clinical Study

    Directory of Open Access Journals (Sweden)

    Peter Fairbairn

    2015-01-01

    Full Text Available Purpose. To present a novel protocol for alveolar bone regeneration in parallel to early implant placement. Methods. 497 patients in need of extraction and early implant placement with simultaneous bone augmentation were treated in a period of 10 years. In all patients the same specific method was followed and grafting was performed utilizing in situ hardening fully resorbable alloplastic grafting materials consisting of β-tricalcium phosphate and calcium sulfate. The protocol involved atraumatic extraction, implant placement after 4 weeks with simultaneous bone augmentation, and loading of the implant 12 weeks after placement and grafting. Follow-up periods ranged from 6 months to 10 years (mean of 4 years. Results. A total of 601 postextraction sites were rehabilitated in 497 patients utilizing the novel protocol. Three implants failed before loading and three implants failed one year after loading, leaving an overall survival rate of 99.0%. Conclusions. This standardized protocol allows successful long-term functional results regarding alveolar bone regeneration and implant rehabilitation. The concept of placing the implant 4 weeks after extraction, augmenting the bone around the implant utilizing fully resorbable, biomechanically stable, alloplastic materials, and loading the implant at 12 weeks seems to offer advantages when compared with traditional treatment modalities.

  4. A simulation study of TaMAC protocol using network simulator 2.

    Science.gov (United States)

    Ullah, Sana; Kwak, Kyung Sup

    2012-10-01

    A Wireless Body Area Network (WBAN) is expected to play a significant role in future healthcare system. It interconnects low-cost and intelligent sensor nodes in, on, or around a human body to serve a variety of medical applications. It can be used to diagnose and treat patients with chronic diseases such as hypertensions, diabetes, and cardiovascular diseases. The lightweight sensor nodes integrated in WBAN require low-power operation, which can be achieved using different optimization techniques. We introduce a Traffic-adaptive MAC protocol (TaMAC) for WBAN that supports dual wakeup mechanisms for normal, emergency, and on-demand traffic. In this letter, the TaMAC protocol is simulated using a well-known Network Simulator 2 (NS-2). The problem of multiple emergency nodes is solved using both wakeup radio and CSMA/CA protocol. The power consumption, delay, and throughput performance are closely compared with beacon-enabled IEEE 802.15.4 MAC protocol using extensive simulations.

  5. MetaNetwork : A computational protocol for the genetic study of metabolic networks

    NARCIS (Netherlands)

    Fu, Jingyuan; Swertz, Morris A.; Keurentjes, Joost J. B.; Jansen, Ritsert C.

    2007-01-01

    We here describe the MetaNetwork protocol to reconstruct metabolic networks using metabolite abundance data from segregating populations. MetaNetwork maps metabolite quantitative trait loci (mQTLs) underlying variation in metabolite abundance in individuals of a segregating population using a

  6. MetaNetwork: a computational protocol for the genetic study of metabolic networks

    NARCIS (Netherlands)

    Fu, J.; Swertz, M.A.; Keurentjes, J.J.B.; Jansen, R.C.

    2007-01-01

    We here describe the MetaNetwork protocol to reconstruct metabolic networks using metabolite abundance data from segregating populations. MetaNetwork maps metabolite quantitative trait loci (mQTLs) underlying variation in metabolite abundance in individuals of a segregating population using a

  7. Benchmarking pediatric cranial CT protocols using a dose tracking software system: a multicenter study.

    Science.gov (United States)

    De Bondt, Timo; Mulkens, Tom; Zanca, Federica; Pyfferoen, Lotte; Casselman, Jan W; Parizel, Paul M

    2017-02-01

    To benchmark regional standard practice for paediatric cranial CT-procedures in terms of radiation dose and acquisition parameters. Paediatric cranial CT-data were retrospectively collected during a 1-year period, in 3 different hospitals of the same country. A dose tracking system was used to automatically gather information. Dose (CTDI and DLP), scan length, amount of retakes and demographic data were stratified by age and clinical indication; appropriate use of child-specific protocols was assessed. In total, 296 paediatric cranial CT-procedures were collected. Although the median dose of each hospital was below national and international diagnostic reference level (DRL) for all age categories, statistically significant (p-value benchmarking showed that further dose optimization and standardization is possible by using age-stratified protocols for paediatric cranial CT. Moreover, having a dose tracking system revealed that adult protocols are still applied for paediatric CT, a practice that must be avoided. • Significant differences were observed in the delivered dose between age-groups and hospitals. • Using age-adapted scanning protocols gives a nearly linear dose increase. • Sharing dose-data can be a trigger for hospitals to reduce dose levels.

  8. Alcohol prevention at sporting events: study protocol for a quasi-experimental control group study

    Directory of Open Access Journals (Sweden)

    Natalie Durbeej

    2016-06-01

    Full Text Available Abstract Background Alcohol intoxication and overserving of alcohol at sporting events are of great concern, given the relationships between alcohol consumption, public disturbances, and violence. During recent years this matter has been on the agenda for Swedish policymakers, authorities and key stakeholders, with demands that actions be taken. There is promising potential for utilizing an environmental approach to alcohol prevention as a strategy to reduce the level of alcohol intoxication among spectators at sporting events. Examples of prevention strategies may be community mobilization, Responsible Beverage Service training, policy work, and improved controls and sanctions. This paper describes the design of a quasi-experimental control group study to examine the effects of a multi-component community-based alcohol intervention at matches in the Swedish Premier Football League. Methods A baseline assessment was conducted during 2015 and at least two follow-up assessments will be conducted in 2016 and 2017. The two largest cities in Sweden are included in the study, with Stockholm as the intervention area and Gothenburg as the control area. The setting is Licensed Premises (LP inside and outside Swedish football arenas, in addition to arena entrances. Spectators are randomly selected and invited to participate in the study by providing a breath alcohol sample as a proxy for Blood Alcohol Concentration (BAC. Actors are hired and trained by an expert panel to act out a standardized scene of severe pseudo-intoxication. Four types of cross-sectional data are generated: (i BAC levels among ≥ 4 200 spectators, frequency of alcohol service to pseudo-intoxicated patrons attempting to purchase alcohol at LP (ii outside the arenas (≥200 attempts and (iii inside the arenas (≥ 200 attempts, and (iv frequency of security staff interventions towards pseudo-intoxicated patrons attempting to enter the arenas (≥ 200 attempts. Discussion There

  9. Alcohol prevention at sporting events: study protocol for a quasi-experimental control group study.

    Science.gov (United States)

    Durbeej, Natalie; Elgán, Tobias H; Jalling, Camilla; Gripenberg, Johanna

    2016-06-06

    Alcohol intoxication and overserving of alcohol at sporting events are of great concern, given the relationships between alcohol consumption, public disturbances, and violence. During recent years this matter has been on the agenda for Swedish policymakers, authorities and key stakeholders, with demands that actions be taken. There is promising potential for utilizing an environmental approach to alcohol prevention as a strategy to reduce the level of alcohol intoxication among spectators at sporting events. Examples of prevention strategies may be community mobilization, Responsible Beverage Service training, policy work, and improved controls and sanctions. This paper describes the design of a quasi-experimental control group study to examine the effects of a multi-component community-based alcohol intervention at matches in the Swedish Premier Football League. A baseline assessment was conducted during 2015 and at least two follow-up assessments will be conducted in 2016 and 2017. The two largest cities in Sweden are included in the study, with Stockholm as the intervention area and Gothenburg as the control area. The setting is Licensed Premises (LP) inside and outside Swedish football arenas, in addition to arena entrances. Spectators are randomly selected and invited to participate in the study by providing a breath alcohol sample as a proxy for Blood Alcohol Concentration (BAC). Actors are hired and trained by an expert panel to act out a standardized scene of severe pseudo-intoxication. Four types of cross-sectional data are generated: (i) BAC levels among ≥ 4 200 spectators, frequency of alcohol service to pseudo-intoxicated patrons attempting to purchase alcohol at LP (ii) outside the arenas (≥200 attempts) and (iii) inside the arenas (≥ 200 attempts), and (iv) frequency of security staff interventions towards pseudo-intoxicated patrons attempting to enter the arenas (≥ 200 attempts). There is an urgent need nationally and internationally to

  10. CardioBengo study protocol: a population based cardiovascular longitudinal study in Bengo Province, Angola

    Directory of Open Access Journals (Sweden)

    João M. Pedro

    2016-03-01

    Full Text Available Abstract Background Cardiovascular diseases and other non-communicable diseases are major causes of morbidity and mortality, responsible for 38 million deaths in 2012, 75 % occurring in low- and middle-income countries. Most of these countries are facing a period of epidemiological transition, being confronted with an increased burden of non-communicable diseases, which challenge health systems mainly designed to deal with infectious diseases. With the adoption of the World Health Organization “Global Action Plan for the Prevention and Control of non-communicable diseases, 2013–2020”, the national dimension of risk factors for non-communicable diseases must be reported on a regular basis. Angola has no national surveillance system for non-communicable diseases, and periodic population-based studies can help to overcome this lack of information. CardioBengo will collect information on risk factors, awareness rates and prevalence of symptoms relevant to cardiovascular diseases, to assist decision makers in the implementation of prevention and treatment policies and programs. Methods CardioBengo is designed as a research structure that comprises a cross-sectional component, providing baseline information and the assembling of a cohort to follow-up the dynamics of cardiovascular diseases risk factors in the catchment area of the Dande Health and Demographic Surveillance System of the Health Research Centre of Angola, in Bengo Province, Angola. The World Health Organization STEPwise approach to surveillance questionnaires and procedures will be used to collect information on a representative sex-age stratified sample, aged between 15 and 64 years old. Discussion CardioBengo will recruit the first population cohort in Angola designed to evaluate cardiovascular diseases risk factors. Using the structures in place of the Dande Health and Demographic Surveillance System and a reliable methodology that generates comparable results with other

  11. Zinc supplementation in pre-diabetes: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Ranasinghe, Priyanga; Jayawardena, Ranil; Pigera, A S A D; Katulanda, Prasad; Constantine, Godwin R; Galappaththy, Priyadarshani

    2013-02-19

    The number of people with diabetes is increasing worldwide, especially in developing South Asian countries. Therefore, preventing diabetes at the early stages has become an important issue. Recent clinical trials, systematic reviews, and meta-analysis have shown that zinc has beneficial effects on glycemic and metabolic control in those with diabetes. The present study is designed to evaluate the effects of zinc supplementation on glycemic control and other metabolic parameters in those with pre-diabetes. The study will be conducted as a randomized, double-blind, placebo-controlled clinical trial for a period of 12 months at the Faculty of Medicine, University of Colombo, Sri Lanka. The study has been approved by the Ethics Review Committee of Faculty of Medicine, University of Colombo (EC/11/189). A total of 200 adults (age 18-60 years) with pre-diabetes will be recruited for the study. They will be stratified according to age, gender, and body mass index and randomly assigned into the test and placebo groups on a 1:1 ratio. The zinc capsules, each weighing 456 mg, will contain the following ingredients:zinc sulfate monohydrate 55.096 mg (elemental zinc 20 mg), lactose monohydrate 399.504 mg, and stearic acid 1.400 mg. The placebo capsule with the same weight will be comprised of lactose monohydrate 454.600 mg and stearic acid 1.400 mg. The subjects will receive either zinc 20 mg capsules or placebo daily for a period of 12 months. The study drugs will be double blinded to both investigators and subjects. The visits and the evaluations will be done as follows: screening (visit 0), 1 month (visit 1), 3 month (visit 2), 6 month (visit 3), and 12 month (visit 4). The following primary outcome measures will be evaluated:fasting plasma glucose (FPG), post oral glucose tolerance test (OGTT), serum insulin, HbA1c, total/low-density lipoprotein (LDL)/high-density lipoprotein (HDL) cholesterol, triglycerides, serum zinc, and appetite using a visual analog scale. Secondary

  12. Health care access for rural youth on equal terms? A mixed methods study protocol in northern Sweden.

    Science.gov (United States)

    Goicolea, Isabel; Carson, Dean; San Sebastian, Miguel; Christianson, Monica; Wiklund, Maria; Hurtig, Anna-Karin

    2018-01-11

    The purpose of this paper is to propose a protocol for researching the impact of rural youth health service strategies on health care access. There has been no published comprehensive assessment of the effectiveness of youth health strategies in rural areas, and there is no clearly articulated model of how such assessments might be conducted. The protocol described here aims to gather information to; i) Assess rural youth access to health care according to their needs, ii) Identify and understand the strategies developed in rural areas to promote youth access to health care, and iii) Propose actions for further improvement. The protocol is described with particular reference to research being undertaken in the four northernmost counties of Sweden, which contain a widely dispersed and diverse youth population. The protocol proposes qualitative and quantitative methodologies sequentially in four phases. First, to map youth access to health care according to their health care needs, including assessing horizontal equity (equal use of health care for equivalent health needs,) and vertical equity (people with greater health needs should receive more health care than those with lesser needs). Second, a multiple case study design investigates strategies developed across the region (youth clinics, internet applications, public health programs) to improve youth access to health care. Third, qualitative comparative analysis of the 24 rural municipalities in the region identifies the best combination of conditions leading to high youth access to health care. Fourth, a concept mapping study involving rural stakeholders, care providers and youth provides recommended actions to improve rural youth access to health care. The implementation of this research protocol will contribute to 1) generating knowledge that could contribute to strengthening rural youth access to health care, as well as to 2) advancing the application of mixed methods to explore access to health care.

  13. Shock in the first 24 h of intensive care unit stay: observational study of protocol-based fluid management.

    Science.gov (United States)

    See, Kay Choong; Mukhopadhyay, Amartya; Lau, Samuel Chuan-Xian; Tan, Sandra Ming-Yien; Lim, Tow Keang; Phua, Jason

    2015-05-01

    Precision in fluid management for shock could lead to better clinical outcomes. We evaluated the association of protocol-based fluid management with intensive care unit (ICU) and hospital mortality. We performed an observational study of mechanically ventilated patients admitted directly from our emergency department to the ICU from August 2011 to December 2013, who had circulatory shock in the first 24 h of ICU stay (systolic blood pressure 4 mmol/L). Patients with onset of shock beyond 24 h of ICU stay were excluded. Protocol-based fluid management required close physician-nurse cooperation and computerized documentation, checking for fluid response (≥10% arterial pulse pressure or stroke volume increase after two consecutive 250-mL crystalloid boluses), and fluid loading with repeated 500-mL boluses until fluid response became negative. Six hundred twelve mechanically ventilated patients with shock (mean [±SD] age, 63.0 years [16.5]; 252 or 41.2% females; mean Acute Physiology and Chronic Health Evaluation II score, 30.2 [8.8]) were studied. The fluid management protocol was used 455 times for 242 patients (39.5% of 612 patients) within the first 24 h of ICU stay, with 244 (53.6% of 455) positive responses. Adjusted for age, sex, Acute Physiology and Chronic Health Evaluation II score, comorbidity, and admission year, protocol use was associated with reduced ICU mortality (odds ratio, 0.60; 95% confidence interval, 0.39-0.94; P = 0.025) but not hospital mortality (odds ratio, 0.82; 95% confidence interval, 0.54-1.23; P = 0.369). Among mechanically ventilated patients with shock within the first 24 h of ICU stay, about half had positive fluid responses. Adherence to protocol-based fluid management was associated with improved ICU survival.

  14. Study protocol for the dabigatran, apixaban, rivaroxaban, edoxaban, warfarin comparative effectiveness research study.

    Science.gov (United States)

    Krumme, Alexis A; Pawar, Ajinkya; Schneeweiss, Sebastian; Glynn, Robert J; Choudhry, Niteesh K; Kulldorff, Martin; Ortiz, Adrian Santiago; Avorn, Jerome; Gagne, Joshua J

    2018-01-01

    Since 2010, four oral anticoagulants have been approved for marketing in addition to warfarin for treatment of thromboembolic disease. Limited head-to-head data exist comparing these treatments, leaving patients and clinicians with little guidance for selecting a strategy that balances recurrence reduction with bleeding risk. In the dabigatran, apixaban, rivaroxban, edoxaban and warfarin comparative effectiveness research study, we compare all five currently available oral anticoagulant agents for the extended treatment of deep venous thrombosis and pulmonary embolism, as well as no extended treatment, and evaluate whether results differ in specific sub-populations. As our population includes Medicare novel anticoagulant users and large numbers of commercially insured and Medicaid patients, our results will likely be transportable to the majority of US patients experiencing a DVT or pulmonary embolism. NCT03271450.

  15. Study protocol: imaging brain development in the Childhood to Adolescence Transition Study (iCATS).

    Science.gov (United States)

    Simmons, Julian G; Whittle, Sarah L; Patton, George C; Dudgeon, Paul; Olsson, Craig; Byrne, Michelle L; Mundy, Lisa K; Seal, Marc L; Allen, Nicholas B

    2014-04-30

    Puberty is a critical developmental phase in physical, reproductive and socio-emotional maturation that is associated with the period of peak onset for psychopathology. Puberty also drives significant changes in brain development and function. Research to date has focused on gonadarche, driven by the hypothalamic-pituitary-gonadal axis, and yet increasing evidence suggests that the earlier pubertal stage of adrenarche, driven by the hypothalamic-pituitary-adrenal axis, may play a critical role in both brain development and increased risk for disorder. We have established a unique cohort of children who differ in their exposure to adrenarcheal hormones. This presents a unique opportunity to examine the influence of adrenarcheal timing on brain structural and functional development, and subsequent health outcomes. The primary objective of the study is to explore the hypothesis that patterns of structural and functional brain development will mediate the relationship between adrenarcheal timing and indices of affect, self-regulation, and mental health symptoms collected across time (and therefore years of development). Children were recruited based upon earlier or later timing of adrenarche, from a larger cohort, with 128 children (68 female; M age 9.51 years) and one of their parents taking part. Children completed brain MRI structural and functional sequences, provided saliva samples for adrenarcheal hormones and immune biomarkers, hair for long-term cortisol levels, and completed questionnaires, anthropometric measures and an IQ test. Parents completed questionnaires reporting on child behaviour, development, health, traumatic events, and parental report of family environment and parenting style. This study, by examining the neurobiological and behavioural consequences of relatively early and late exposure to adrenarche, has the potential to significantly impact our understanding of pubertal risk processes.

  16. Application of the Putting Women First protocol in a study on violence against immigrant women in Spain.

    Science.gov (United States)

    Torrubiano-Domínguez, Jordi; Vives-Cases, Carmen

    2013-01-01

    In this paper, we describe our experience of using the Putting Women First protocol in the design and implementation of a cross-sectional study on violence against women (VAW) among 1607 immigrant women from Morocco, Ecuador and Romania living in Spain in 2011. The Putting Women First protocol is an ethical guideline for VAW research, which includes recommendations to ensure the safety of the women involved in studies on this subject. The response rate in this study was 59.3%. The prevalence of VAW cases last year was 11.7%, of which 15.6% corresponded to Ecuadorian women, 10.9% to Moroccan women and 8.6% to Romanian women. We consider that the most important goal for future research is the use of VAW scales validated in different languages, which would help to overcome the language barriers encountered in this study. Copyright © 2012 SESPAS. Published by Elsevier Espana. All rights reserved.

  17. Egyptian Journal of Medical Laboratory Sciences: Submissions

    African Journals Online (AJOL)

    Egyptian Journal of Medical Laboratory Sciences: Submissions. Journal Home > About the Journal > Egyptian Journal of Medical Laboratory Sciences: Submissions. Log in or Register to get access to full text downloads.

  18. African Journal of Finance and Management: Submissions

    African Journals Online (AJOL)

    African Journal of Finance and Management: Submissions. Journal Home > About the Journal > African Journal of Finance and Management: Submissions. Log in or Register to get access to full text downloads.

  19. Improving GHB withdrawal with baclofen: study protocol for a feasibility study for a randomised controlled trial.

    Science.gov (United States)

    Lingford-Hughes, Anne; Patel, Yash; Bowden-Jones, Owen; Crawford, Mike J; Dargan, Paul I; Gordon, Fabiana; Parrott, Steve; Weaver, Tim; Wood, David M

    2016-09-27

    GHB (gamma-hydroxybutyrate) and its pro-drugs GBL (gamma-butyrolactone) and 1,4-butanediol (1,4-BD) are central nervous system depressants whose street names include 'G' and 'liquid ecstasy'. They are used recreationally predominately for their stimulant and pro-sexual effects or for sedation to help with sleep and/or to 'come down' after using stimulant recreational drugs. Although overall population prevalence is low (0.1 %), in some groups such as men who have sex with men, GHB/GBL use may reach 20 %. GHB/GBL dependence may be associated with severe withdrawal with individuals presenting either acutely to emergency departments or to addiction services for support. Benzodiazepines are currently prescribed for GHB/GBL detoxification but do not prevent all complications, such as behavioural disinhibition, that may require hospitalisation or admission to a high dependency/intensive care unit. The GABAB receptor mediates most effects of GHB/GBL and the GABAB agonist, baclofen, has shown promise as an adjunct to benzodiazepines in reducing withdrawal severity when prescribed both during withdrawal and as a 2-day 'preload' prior to detoxification. The key aim of this feasibility study is provide information about recruitment and characteristics of the proposed outcome measure (symptom severity, complications including delirium and treatment escalation) to inform an application for a definitive randomised placebo controlled trial to determine the role of baclofen in the management of GHB/GBL withdrawal and whether starting baclofen 2 days earlier improves outcomes further. This is a prospective, randomised, double-blind, placebo-controlled feasibility study that will recruit participants (aged over 18 years) who are GHB/GBL-dependent and wish to undergo planned GHB/GBL detoxification or are at risk of acute withdrawal and are inpatients requiring unplanned withdrawal. We aim to recruit 88 participants: 28 unplanned inpatients and 60 planned outpatients. During

  20. Individual and occupational risk factors for knee osteoarthritis – Study protocol of a case control study

    Directory of Open Access Journals (Sweden)

    Bouillon Bertil

    2008-02-01

    Full Text Available Abstract Background Knee osteoarthritis (OA is one of the frequent and functionally impairing disorders of the musculoskeletal system. In the literature, a number of occupational risk factors are discussed as being related to the development and progress of knee joint diseases, e.g. working in kneeling or squatting posture, lifting and carrying of heavy weights. The importance of the single risk factors and the possibility of prevention are currently under discussion. Besides the occupational factors, a number of individual risk factors are important, too. The distinction between work-related factors and individual factors is crucial in assessing the risk and in deriving preventive measures in occupational health. In existing studies, the occupational stress is determined mainly by surveys in employees and/or by making assumptions about individual occupations. Direct evaluation of occupational exposure has been performed only exceptionally. The aim of the research project ArGon is the assessment of different occupational factors in relation to individual factors (e.g. constitutional factors, leisure time activities, sports, which might influence the development and/or progression of knee (OA. The project is designed as a case control study. Methods/Design To raise valid data about the physical stress associated with occupational and leisure time activities, patients with and without knee OA are questioned by means of a standardised questionnaire and an interview. The required sample size was estimated to 800 cases and an equal number of controls. The degree and localisation of the knee cartilage or joint damages in the cases are documented on the basis of radiological, arthroscopic and/or operative findings in a patient record. Furthermore, occupational exposure is analysed at selected workplaces. To evaluate the answers provided in the questionnaire, work analysis is performed. Discussion In this research project, specific information on the

  1. The Melbourne Diabetes Prevention Study (MDPS): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Davis-Lameloise, Nathalie; Hernan, Andrea; Janus, Edward D; Stewart, Elizabeth; Carter, Rob; Bennett, Catherine M; O'Reilly, Sharleen; Philpot, Benjamin; Vartiainen, Erkki; Dunbar, James A

    2013-01-31

    Worldwide, type 2 diabetes (T2DM) prevalence has more than doubled over two decades. In Australia, diabetes is the second highest contributor to the burden of disease. Lifestyle modification programs comprising diet changes, weight loss and moderate physical activity, have been proven to reduce the incidence of T2DM in high risk individuals.As part of the Council of Australia Governments, the State of Victoria committed to develop and support the diabetes prevention program 'Life! Taking action on diabetes' (Life!) which has direct lineage from effective clinical and implementation trials from Finland and Australia. The Melbourne Diabetes Prevention Study (MDPS) has been set up to evaluate the effectiveness and cost-effectiveness of a specific version of the Life! program. We intend to recruit 796 participants for this open randomized clinical trial; 398 will be allocated to the intervention arm and 398 to the usual care arm. Several methods of recruitment will be used in order to maximize the number of participants. Individuals aged 50 to 75 years will be screened with a risk tool (AUSDRISK) to detect those at high risk of developing T2DM. Those with existing diabetes will be excluded. Intervention participants will undergo anthropometric and laboratory tests, and comprehensive surveys at baseline, following the fourth group session (approximately three months after the commencement of the intervention) and 12 months after commencement of the intervention, while control participants will undergo testing at baseline and 12 months only.The intervention consists of an initial individual session followed by a series of five structured-group sessions. The first four group sessions will be carried out at two week intervals and the fifth session will occur eight months after the first group session. The intervention is based on the Health Action Process Approach (HAPA) model and sessions will empower and enable the participants to follow the five goals of the Life

  2. A pilot study of a smoking cessation intervention for women living with HIV: study protocol

    Directory of Open Access Journals (Sweden)

    Kim SS

    2017-02-01

    Full Text Available Sun S Kim, Sabreen Darwish, Sang A Lee, Rosanna F DeMarco Department of Nursing, College of Nursing and Health Sciences, University of Massachusetts Boston, Boston, MA, USA Background: Prevalence of cigarette smoking is substantially higher among people living with human immunodeficiency virus (HIV than the general population in the USA. Women living with HIV (WLHIV who smoke are at higher risk of developing acquired immunodeficiency syndrome and have a higher mortality rate than nonsmoking WLHIV. Compared to men, women generally require more intensive counseling for smoking cessation. The primary aim of this study is to examine the acceptability and feasibility of a videoconferencing smoking cessation intervention that is tailored to the specific needs of WLHIV. Methods: A total of 50 WLHIV will be randomized at a ratio of 1:1 to either a videoconferencing or a telephone counseling arm. Both arms have the same cessation intervention, that is, eight weekly individualized counseling sessions of 30-minute cognitive behavioral therapy plus active nicotine patches for 8 weeks. The only difference between the two arms is the delivery mode of the counseling, that is, telephone video call vs. telephone voice call. Data collection is scheduled at baseline and three follow-up points: 1, 3, and 6 months from the target quit day. Data will be analyzed using STATA 14. The primary outcome is a 6-month prolonged abstinence. Home-based salivary cotinine test will be conducted to verify self-reported smoking abstinence using a NicAlert® test strip, while a research coordinator monitors the whole process by a telephone video call. Conclusion: The study is a two-arm parallel-group pilot clinical trial of a smoking cessation intervention. It attempts to examine whether videoconferencing smoking cessation intervention will be acceptable and feasible for WLHIV and will yield a better cessation outcome than telephone counseling intervention. Findings may have the

  3. Ghana randomized air pollution and health study (GRAPHS): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Jack, Darby W; Asante, Kwaku Poku; Wylie, Blair J; Chillrud, Steve N; Whyatt, Robin M; Ae-Ngibise, Kenneth A; Quinn, Ashlinn K; Yawson, Abena Konadu; Boamah, Ellen Abrafi; Agyei, Oscar; Mujtaba, Mohammed; Kaali, Seyram; Kinney, Patrick; Owusu-Agyei, Seth

    2015-09-22

    Household air pollution exposure is a major health risk, but validated interventions remain elusive. The Ghana Randomized Air Pollution and Health Study (GRAPHS) is a cluster-randomized trial that evaluates the efficacy of clean fuels (liquefied petroleum gas, or LPG) and efficient biomass cookstoves in the Brong-Ahafo region of central Ghana. We recruit pregnant women into LPG, efficient cookstove, and control arms and track birth weight and physician-assessed severe pneumonia incidence in the first year of life. A woman is eligible to participate if she is in the first or second trimester of pregnancy and carrying a live singleton fetus, if she is the primary cook, and if she does not smoke. We hypothesize that babies born to intervention mothers will weigh more and will have fewer cases of physician-assessed severe pneumonia in the first year of life. Additionally, an extensive personal air pollution exposure monitoring effort opens the way for exposure-response analyses, which we will present alongside intention-to-treat analyses. Major funding was provided by the National Institute of Environmental Health Sciences, The Thrasher Research Fund, and the Global Alliance for Clean Cookstoves. Household air pollution exposure is a major health risk that requires well-tested interventions. GRAPHS will provide important new evidence on the efficacy of both efficient biomass cookstoves and LPG, and will thus help inform health and energy policies in developing countries. The trial was registered with clinicaltrials.gov on 13 April 2011 with the identifier NCT01335490 .

  4. (dtltt) protocol

    African Journals Online (AJOL)

    2013-03-01

    Mar 1, 2013 ... STLODGSTT protocol uses static value of threshold bandwidth to allocate available bandwidth to the asynchronous traffic, as such, the ... 12, 13 ] SAFENET [14], Manufacturing Automation. Protocol (MAP) [15], High-Speed ... the threshold bandwidth used in allocating available bandwidth to the n heavily ...

  5. Mitigating aflatoxin exposure to improve child growth in Eastern Kenya: study protocol for a randomized controlled trial

    OpenAIRE

    Hoffmann, Vivian; Jones, Kelly; Leroy, Jef

    2015-01-01

    Background While the few studies that have looked at the association between stunting and aflatoxin exposure have found surprisingly large effects, the results remain inconclusive due to a lack of randomized controlled studies. This protocol describes a non-blinded, cluster-randomized controlled trial with the specific objective of testing the impact of reduced aflatoxin exposure on (individual) child linear growth. Methods/Design Participants were recruited from among households containing w...

  6. ESPACOMP Medication Adherence Reporting Guidelines (EMERGE): a reactive-Delphi study protocol.

    Science.gov (United States)

    Helmy, R; Zullig, L L; Dunbar-Jacob, J; Hughes, D A; Vrijens, B; Wilson, I B; De Geest, S

    2017-02-10

    Medication adherence is fundamental to achieving optimal patient outcomes. Reporting research on medication adherence suffers from some issues-including conceptualisation, measurement and data analysis-that thwart its advancement. Using the ABC taxonomy for medication adherence as the conceptual basis, a steering committee of members of the European Society for Patient Adherence, COMpliance, and Persistence (ESPACOMP) launched an initiative to develop ESPACOMP Medication Adherence Reporting Guidelines (EMERGE). This paper is a protocol for a Delphi study that aims to build consensus among a group of topic experts regarding an item list that will support developing EMERGE. This study uses a reactive-Delphi design where a group of topic experts will be asked to rate the relevance and clarity of an initial list of items, in addition to suggesting further items and/or modifications of the initial items. The initial item list, generated by the EMERGE steering committee through a structured process, consists of 26 items distributed in 2 sections: 4 items representing the taxonomy-based minimum reporting criteria, and 22 items organised according to the common reporting sections. A purposive sample of experts will be selected from relevant disciplines and diverse geographical locations. Consensus will be achieved through predefined decision rules to keep, delete or modify the items. An iterative process of online survey rounds will be carried out until consensus is reached. An ethics approval was not required for the study according to the Swiss federal act on research involving human beings. The participating experts will be asked to give an informed consent. The results of this Delphi study will feed into EMERGE, which will be disseminated through peer-reviewed publications and presentations at conferences. Additionally, the steering committee will encourage their endorsement by registering the guidelines at the Enhancing the QUAlity and Transparency Of health Research

  7. Postoperative Delirium after elective and emergency surgery: analysis and checking of risk factors. A study protocol

    Directory of Open Access Journals (Sweden)

    Gagliardi Stefano

    2005-05-01

    Scale (GCS, Cognitive state (SPMSQ, Functional state (ADL and IADL, Psychological Distress (HADS, Cumulative Illness Rating Scale (CIRS, Hypotension (classified in: light; moderate and severe and duration, Blood loss (classified in: 2 lt, Blood transfusions ( 2 lt, Quantity of red cells and plasma transfusions, Visual VAS / SVS (timing: I-II-III post-operative day, Red cells and Plasma transfusions, Blood count evaluation and Saturation (O2%, Postoperative analgesia (Emilia-Romagna protocol, Presence of malignant tumoral disease, APACHE Score II. Moreover the presence of some relevant genetic polymorphisms will be studied in different genes such as IL-6, IL-10, TNF-alpha, and IL-1 cluster.

  8. Brief intervention to reduce risky drinking in pregnancy: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Wilson Graeme B

    2012-09-01

    delivery, and retention in the study population, to inform power calculations for a definitive trial. The health-economics component will establish how cost-effectiveness will be assessed, and examine which data on health service resource use should be collected in a main trial. Participants’ views on instruments and procedures will be sought to confirm their acceptability. Discussion The study will produce a full trial protocol with robust sample-size calculations to extend evidence on effectiveness of screening and brief intervention. Trial Registration Current Controlled Trials ISRCTN43218782

  9. Physical activity, immune function and inflammation in kidney patients (the PINK study): a feasibility trial protocol.

    Science.gov (United States)

    Highton, Patrick James; Neale, Jill; Wilkinson, Thomas J; Bishop, Nicolette C; Smith, Alice C

    2017-05-29

    Patients with chronic kidney disease (CKD) display increased infection-related mortality and elevated cardiovascular risk only partly attributed to traditional risk factors. Patients with CKD also exhibit a pro-inflammatory environment and impaired immune function. Aerobic exercise has the potential to positively impact these detriments, but is under-researched in this patient population. This feasibility study will investigate the effects of acute aerobic exercise on inflammation and immune function in patients with CKD to inform the design of larger studies intended to ultimately influence current exercise recommendations. Patients with CKD, including renal transplant recipients, will visit the laboratory on two occasions, both preceded by appropriate exercise, alcohol and caffeine restrictions. On visit 1, baseline assessments will be completed, comprising anthropometrics, body composition, cardiovascular function and fatigue and leisure time exercise questionnaires. Participants will then undertake an incremental shuttle walk test to estimate predicted peak O 2 consumption (VO 2 peak). On visit 2, participants will complete a 20 min shuttle walk at a constant speed to achieve 85% estimated VO 2 peak. Blood and saliva samples will be taken before, immediately after and 1 hour after this exercise bout. Muscle O 2 saturation will be monitored throughout exercise and recovery. Age and sex-matched non-CKD 'healthy control' participants will complete an identical protocol. Blood and saliva samples will be analysed for markers of inflammation and immune function, using cytometric bead array and flow cytometry techniques. Appropriate statistical tests will be used to analyse the data. A favourable opinion was granted by the East Midlands-Derby Research Ethics Committee on 18 September 2015 (ref 15/EM/0391), and the study was approved and sponsored by University Hospitals of Leicester Research and Innovation (ref 11444). The study was registered with ISRCTN (ref

  10. PREventive Care Infrastructure based On Ubiquitous Sensing (PRECIOUS): A Study Protocol.

    Science.gov (United States)

    Castellano-Tejedor, Carmina; Moreno, Jordi; Ciudin, Andrea; Parramón, Gemma; Lusilla-Palacios, Pilar

    2017-05-31

    mHealth has experienced a huge growth during the last decade. It has been presented as a new and promising pathway to increase self-management of health and chronic conditions in several populations. One of the most prolific areas of mHealth has been healthy lifestyles promotion. However, few mobile apps have succeeded in engaging people and ensuring sustained use. This paper describes the pilot test protocol of the PReventive Care Infrastructure based on Ubiquitous Sensing (PRECIOUS) project, aimed at validating the PRECIOUS system with end users. This system includes, within a motivational framework, the Bodyguard2 sensor (accelerometer with heart rate monitoring) and the PRECIOUS app. This is a pilot experimental study targeting morbidly obese prediabetic patients who will be randomized to three conditions: (1) Group 1 - Control group (Treatment as usual with the endocrinologist and the nurse + Bodyguard2), (2) Group 2 - PRECIOUS system (Bodyguard2 + PRECIOUS app), and (3) Group 3 - PRECIOUS system (Bodyguard2 + PRECIOUS app + Motivational Interviewing). The duration of the study will be 3 months with scheduled follow-up appointments within the scope of the project at Weeks 3, 5, 8, and 12. During the study, several measures related to healthy lifestyles, weight management, and health-related quality of life will be collected to explore the effectiveness of PRECIOUS to foster behavior change, as well as user acceptance, usability, and satisfaction with the solution. Because of the encouraging results shown in similar scientific work analyzing health apps acceptance in clinical settings, we expect patients to widely accept and express satisfaction with PRECIOUS. We also expect to find acceptable usability of the preventive health solution. The recruitment of the pilot study has concluded with the inclusion of 31 morbidly obese prediabetic patients. Results are expected to be available in mid-2017. Adopting and maintaining healthy habits may be challenging in

  11. Factors influencing psychological, social and health outcomes after major burn injuries in adults: cohort study protocol.

    Science.gov (United States)

    Druery, Martha; Newcombe, Peter A; Cameron, Cate M; Lipman, Jeffrey

    2017-06-17

    The goal of burn care is that 'the quality of the outcome must be worth the pain of survival'. More research is needed to understand how best to deliver care for patients with burns to achieve this aim. Loss of independence, function as well as loss of income for patients with burns and carers cause a significant burden at both individual and societal levels. Much is being done to advance knowledge in the clinical care field; however, there has been a paucity of research exploring psychosocial outcomes. This paper describes the study background and methods, as implemented in an Australian cohort study of psychosocial outcomes after major burn injuries. In this inception cohort study, a target sample of 230 participants, aged 18 years or over, admitted to a single statewide burns centre with a burn injury are identified by hospital staff for inclusion. Baseline survey data are collected either in person or by telephone within 28 days of the injury and participants then followed up with telephone interviews at 3, 6 and 12 months postburn. Injury and burns treatment information is collected from medical records. Social support is measured as a predictor variable using the Multidimensional Scale of Perceived Social Support. Outcome data are collected via standardised measures in the domains of Quality of Life (SF-12, EQ-5D, BSHS-B), depression (PHQ-9), post-traumatic stress disorder (PCL-C, PAS), community integration (CIQ-R) and Quality-Adjusted Life Years (EQ-5D). Additional survey questions measure life satisfaction, return to work and public services utilisation at 12 months postinjury. Data analysis methods will include analysis of variance, Pearson correlation and hierarchical multiple regression analyses. Hospital-based and University of Queensland Human Research Ethics Committees have approved the protocol. Results from the study will be disseminated at national and international conferences, in peer-reviewed journals and in a doctoral thesis. Australia New

  12. Mortality in Transition: Study Protocol of the PrivMort Project, a multilevel convenience cohort study

    Directory of Open Access Journals (Sweden)

    Darja Irdam

    2016-07-01

    Full Text Available Abstract Background Previous research using routine data identified rapid mass privatisation as an important driver of mortality crisis following the collapse of Communism in Central and Eastern Europe. However, existing studies on the mortality crisis relying on individual level or routine data cannot assess both distal (societal and proximal (individual causes of mortality simultaneously. The aim of the PrivMort Project is to overcome these limitations and to investigate the role of societal factors (particularly rapid mass privatisation and individual-level factors (e.g. alcohol consumption in the mortality changes in post-communist countries. Methods The PrivMort conducts large-sample surveys in Russia, Belarus and Hungary. The approach is unique in comparing towns that have undergone rapid privatisation of their key industrial enterprises with those that experienced more gradual forms of privatisation, employing a multi-level retrospective cohort design that combines data on the industrial characteristics of the towns, socio-economic descriptions of the communities, settlement-level data, individual socio-economic characteristics, and individuals’ health behaviour. It then incorporates data on mortality of different types of relatives of survey respondents, employing a retrospective demographic approach, which enables linkage of historical patterns of mortality to exposures, based on experiences of family members. By May 2016, 63,073 respondents provided information on themselves and 205,607 relatives, of whom 102,971 had died. The settlement-level dataset contains information on 539 settlements and 12,082 enterprises in these settlements in Russia, 96 settlements and 271 enterprises in Belarus, and 52 settlement and 148 enterprises in Hungary. Discussion In addition to reinforcing existing evidence linking smoking, hazardous drinking and unemployment to mortality, the PrivMort dataset will investigate the variation in transition

  13. Mortality in Transition: Study Protocol of the PrivMort Project, a multilevel convenience cohort study.

    Science.gov (United States)

    Irdam, Darja; King, Lawrence; Gugushvili, Alexi; Azarova, Aytalina; Fazekas, Mihaly; Scheiring, Gabor; Stefler, Denes; Doniec, Katarzyna; Horvat, Pia; Kolesnikova, Irina; Popov, Vladimir; Szelenyi, Ivan; Marmot, Michael; Murphy, Michael; McKee, Martin; Bobak, Martin

    2016-07-30

    Previous research using routine data identified rapid mass privatisation as an important driver of mortality crisis following the collapse of Communism in Central and Eastern Europe. However, existing studies on the mortality crisis relying on individual level or routine data cannot assess both distal (societal) and proximal (individual) causes of mortality simultaneously. The aim of the PrivMort Project is to overcome these limitations and to investigate the role of societal factors (particularly rapid mass privatisation) and individual-level factors (e.g. alcohol consumption) in the mortality changes in post-communist countries. The PrivMort conducts large-sample surveys in Russia, Belarus and Hungary. The approach is unique in comparing towns that have undergone rapid privatisation of their key industrial enterprises with those that experienced more gradual forms of privatisation, employing a multi-level retrospective cohort design that combines data on the industrial characteristics of the towns, socio-economic descriptions of the communities, settlement-level data, individual socio-economic characteristics, and individuals' health behaviour. It then incorporates data on mortality of different types of relatives of survey respondents, employing a retrospective demographic approach, which enables linkage of historical patterns of mortality to exposures, based on experiences of family members. By May 2016, 63,073 respondents provided information on themselves and 205,607 relatives, of whom 102,971 had died. The settlement-level dataset contains information on 539 settlements and 12,082 enterprises in these settlements in Russia, 96 settlements and 271 enterprises in Belarus, and 52 settlement and 148 enterprises in Hungary. In addition to reinforcing existing evidence linking smoking, hazardous drinking and unemployment to mortality, the PrivMort dataset will investigate the variation in transition experiences for individual respondents and their families across

  14. Evaluation of the reproducibility of a protocol for the pharmacokinetic study of breast tumors by dynamic magnetic resonance imaging.

    Science.gov (United States)

    Etxano, J; García-Lallana Valbuena, A; Antón Ibáñez, I; Elizalde, A; Pina, L; García-Foncillas, J; Boni, V

    2015-01-01

    To evaluate the reproducibility of a protocol for dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) for the pharmacokinetic study of breast tumors. We carried out this prospective study from October 2009 through December 2009. We studied 12 patients with stage ii-iii invasive breast cancer without prior treatment. Our center's research ethics committee approved the study. The 12 patients underwent on two consecutive days DCE-MRI with a high temporal resolution protocol (21 acquisitions/minute). The data obtained in an ROI traced around the largest diameter of the tumor (ROI 1) and in another ROI traced around the area of the lesion's highest K(trans) intensity (ROI 2) were analyzed separately. We used parametric and nonparametric statistical tests to study the reproducibility and concordance of the principal pharmacokinetic variables (K(trans), Kep, Ve and AUC90). The correlations were very high (r>.80; P.05 for each), but there was a statistically significant difference between the two studies in the values obtained for Ve in ROI 2 (P=.008). The high temporal resolution protocol for DCE-MRI used at out center is very reproducible for the principal pharmacokinetic constants of breast. Copyright © 2012 SERAM. Published by Elsevier España, S.L.U. All rights reserved.

  15. The FLASSH study: protocol for a randomised controlled trial evaluating falls prevention after stroke and two sub-studies.

    Science.gov (United States)

    Batchelor, Frances A; Hill, Keith D; Mackintosh, Shylie F; Said, Catherine M; Whitehead, Craig H

    2009-03-31

    Falls are common in stroke survivors returning home after rehabilitation, however there is currently a lack of evidence about preventing falls in this population. This paper describes the study protocol for the FLASSH (FaLls prevention After Stroke Survivors return Home) project. This randomised controlled trial aims to evaluate the effectiveness of a multi-factorial falls prevention program for stroke survivors who are at high risk of falling when they return home after rehabilitation. Intervention will consist of a home exercise program as well as individualised falls prevention and injury minimisation strategies based on identified risk factors for falls. Additionally, two sub-studies will be implemented in order to explore other key areas related to falls in this population. The first of these is a longitudinal study evaluating the relationship between fear of falling, falls and function over twelve months, and the second evaluates residual impairment in gait stability and obstacle crossing twelve months after discharge from rehabilitation. The results of the FLASSH project will inform falls prevention practice for stroke survivors. If the falls prevention program is shown to be effective, low cost strategies to prevent falls can be implemented for those at risk around the time of discharge from rehabilitation, thus improving safety and quality of life for stroke survivors. The two sub-studies will contribute to the overall understanding and management of falls risk in stroke survivors. This trial is registered with the Australian and New Zealand Clinical Trials Registry (ACTRN012607000398404).

  16. Prednisolone and acupuncture in Bell's palsy: study protocol for a randomized, controlled trial

    Directory of Open Access Journals (Sweden)

    Wang Kangjun

    2011-06-01

    Full Text Available Abstract Background There are a variety of treatment options for Bell's palsy. Evidence from randomized controlled trials indicates corticosteroids can be used as a proven therapy for Bell's palsy. Acupuncture is one of the most commonly used methods to treat Bell's palsy in China. Recent studies suggest that staging treatment is more suitable for Bell's palsy, according to different path-stages of this disease. The aim of this study is to compare the effects of prednisolone and staging acupuncture in the recovery of the affected facial nerve, and to verify whether prednisolone in combination with staging acupuncture is more effective than prednisolone alone for Bell's palsy in a large number of patients. Methods/Design In this article, we report the design and protocol of a large sample multi-center randomized controlled trial to treat Bell's palsy with prednisolone and/or acupuncture. In total, 1200 patients aged 18 to 75 years within 72 h of onset of acute, unilateral, peripheral facial palsy will be assessed. There are six treatment groups, with four treated according to different path-stages and two not. These patients are randomly assigned to be in one of the following six treatment groups, i.e. 1 placebo prednisolone group, 2 prednisolone group, 3 placebo prednisolone plus acute stage acupuncture group, 4 prednisolone plus acute stage acupuncture group, 5 placebo prednisolone plus resting stage acupuncture group, 6 prednisolone plus resting stage acupuncture group. The primary outcome is the time to complete recovery of facial function, assessed by Sunnybrook system and House-Brackmann scale. The secondary outcomes include the incidence of ipsilateral pain in the early stage of palsy (and the duration of this pain, the proportion of patients with severe pain, the occurrence of synkinesis, facial spasm or contracture, and the severity of residual facial symptoms during the study period. Discussion The result of this trial will assess the

  17. African Journal of Infectious Diseases: Submissions

    African Journals Online (AJOL)

    Copying text, photographs, tables or graphics from any source and using it as ones own is considered plagiarism whether or not a reference to the copied portion is given. Submission Preparation Checklist As part of the submission process, authors are required to check off their submission's compliance with all of the ...

  18. Study protocol for a randomised controlled trial of electronic cigarettes versus nicotine patch for smoking cessation.

    Science.gov (United States)

    Bullen, Chris; Williman, Jonathan; Howe, Colin; Laugesen, Murray; McRobbie, Hayden; Parag, Varsha; Walker, Natalie

    2013-03-08

    Electronic cigarettes (e-cigarettes or electronic nicotine delivery systems [ENDS]) are electrically powered devices generally similar in appearance to a cigarette that deliver a propylene glycol and/or glycerol mist to the airway of users when drawing on the mouthpiece. Nicotine and other substances such as flavourings may be included in the fluid vaporised by the device. People report using e-cigarettes to help quit smoking and studies of their effects on tobacco withdrawal and craving suggest good potential as smoking cessation aids. However, to date there have been no adequately powered randomised trials investigating their cessation efficacy or safety. This paper outlines the protocol for this study. Parallel group, 3-arm, randomised controlled trial. People aged ≥18 years resident in Auckland, New Zealand (NZ) who want to quit smoking. Stratified blocked randomisation to allocate participants to either Elusion™ e-cigarettes with nicotine cartridges (16 mg) or with placebo cartridges (i.e. no nicotine), or to nicotine patch (21 mg) alone. PARTICIPANTS randomised to the e-cigarette groups will be told to use them ad libitum for one week before and 12 weeks after quit day, while participants randomised to patches will be told to use them daily for the same period. All participants will be offered behavioural support to quit from the NZ Quitline. Biochemically verified (exhaled carbon monoxide) continuous abstinence at six months after quit day. 657 people (292 in both the nicotine e-cigarette and nicotine patch groups and 73 in the placebo e-cigarettes group) will provide 80% power at p = 0.05 to detect an absolute difference of 10% in abstinence between the nicotine e-cigarette and nicotine patch groups, and 15% between the nicotine and placebo e-cigarette groups. This trial will inform international debate and policy on the regulation and availability of e-cigarettes. If shown to be efficacious and safe, these devices could help many smokers as an

  19. Study protocol for a randomised controlled trial of electronic cigarettes versus nicotine patch for smoking cessation

    Science.gov (United States)

    2013-01-01

    Background Electronic cigarettes (e-cigarettes or electronic nicotine delivery systems [ENDS]) are electrically powered devices generally similar in appearance to a cigarette that deliver a propylene glycol and/or glycerol mist to the airway of users when drawing on the mouthpiece. Nicotine and other substances such as flavourings may be included in the fluid vaporised by the device. People report using e-cigarettes to help quit smoking and studies of their effects on tobacco withdrawal and craving suggest good potential as smoking cessation aids. However, to date there have been no adequately powered randomised trials investigating their cessation efficacy or safety. This paper outlines the protocol for this study. Methods/design Design: Parallel group, 3-arm, randomised controlled trial. Participants: People aged ≥18 years resident in Auckland, New Zealand (NZ) who want to quit smoking. Intervention: Stratified blocked randomisation to allocate participants to either Elusion™ e-cigarettes with nicotine cartridges (16 mg) or with placebo cartridges (i.e. no nicotine), or to nicotine patch (21 mg) alone. Participants randomised to the e-cigarette groups will be told to use them ad libitum for one week before and 12 weeks after quit day, while participants randomised to patches will be told to use them daily for the same period. All participants will be offered behavioural support to quit from the NZ Quitline. Primary outcome: Biochemically verified (exhaled carbon monoxide) continuous abstinence at six months after quit day. Sample size: 657 people (292 in both the nicotine e-cigarette and nicotine patch groups and 73 in the placebo e-cigarettes group) will provide 80% power at p = 0.05 to detect an absolute difference of 10% in abstinence between the nicotine e-cigarette and nicotine patch groups, and 15% between the nicotine and placebo e-cigarette groups. Discussion This trial will inform international debate and policy on the regulation and

  20. Imaging of congenital torticollis in infants: a retrospective study of an institutional protocol.

    Science.gov (United States)

    Boyko, Nicholas; Eppinger, Melissa Ann; Straka-DeMarco, Deborah; Mazzola, Catherine Anne

    2017-08-01

    OBJECTIVE The authors' objectives in this study were to evaluate their institutional protocol and create recommendations for radiographic imaging in infants with torticollis, with or without plagiocephaly, based on a retrospective clinical analysis and literature review. METHODS A retrospective analysis was conducted to identify infants with torticollis who were evaluated by the craniofacial team. The following patients were identified: those who underwent imaging in the form of radiography, CT scanning, or MRI; those who had a secondary diagnosis or additional clinical finding as the indication for imaging; and those with persistent torticollis despite completion of recommended repositioning techniques and physical therapy (PT). RESULTS A total of 683 infants between the ages of 1 day and 335 days (mean age 141.6 days) were referred for management of torticollis. Initial imaging was performed in 48 patients, of whom 44 were identified as having a diagnosis other than torticollis or a significant clinical finding as the indication for imaging. The remaining 4 patients (0.6% of the torticollis population) underwent imaging and did not have an additional diagnosis or a significant clinical finding. There were no abnormal radiological findings in these patients. Of the 639 patients diagnosed with congenital torticollis who did not have a secondary diagnosis that required initial imaging, 99.2% (634 patients) achieved resolution of torticollis with recommended repositioning techniques and completion of PT and without radiography, CT, or MRI. CONCLUSIONS Within the limits of this retrospective study and supporting literature, the authors provide the following recommendations regarding radiographic imaging of infants with congenital torticollis. 1) Clinical examination is sufficient in the diagnosis of congenital torticollis in infants. Radiography, CT scanning, and MRI are not necessary. 2) In cases in which additional clinical or neurological findings are present

  1. The effects of a mobile stress management protocol on nurses working with cancer patients: a preliminary controlled study.

    Science.gov (United States)

    Villani, Daniela; Grassi, Alessandra; Cognetta, Chiara; Cipresso, Pietro; Toniolo, Davide; Riva, Giuseppe

    2012-01-01

    Oncology nurses face extraordinary stresses that may lead to emotional exhaustion, a feeling of emotional distance from patients and burnout. The presentation describes the preliminary results of a study to test the effects of an innovative 4-week 8-session self-help stress management training for oncology nurses supported by mobile tools (Nokia N70 smarthphone). The sample included 16 female oncology nurses with permanent status employed in different oncology hospitals in Milan, Italy. The study used a between-subjects design, comparing the experimental condition (mobile phone stress management protocol) with a control group (neutral videos through mobile phones). In addition to a significant reduction in anxiety state at the end of each session, the experimental group demonstrated a significant improvement in affective change in terms of anxiety trait reduction and coping skills acquisition at the end of the protocol.

  2. Cactus and Visapult: A case study of ultra-high performance distributed visualization using connectionless protocols

    Energy Technology Data Exchange (ETDEWEB)

    Shalf, John; Bethel, E. Wes

    2002-05-07

    This past decade has seen rapid growth in the size, resolution, and complexity of Grand Challenge simulation codes. Many such problems still require interactive visualization tools to make sense of multi-terabyte data stores. Visapult is a parallel volume rendering tool that employs distributed components, latency tolerant algorithms, and high performance network I/O for effective remote visualization of massive datasets. In this paper we discuss using connectionless protocols to accelerate Visapult network I/O and interfacing Visapult to the Cactus General Relativity code to enable scalable remote monitoring and steering capabilities. With these modifications, network utilization has moved from 25 percent of line-rate using tuned multi-streamed TCP to sustaining 88 percent of line rate using the new UDP-based transport protocol.

  3. Protocol to monitor trade agreement food-related aspects: the Fiji case study.

    Science.gov (United States)

    Ravuvu, Amerita; Friel, Sharon; Thow, Anne Marie; Snowdon, Wendy; Wate, Jillian

    2017-04-26

    Despite the growing rates of obesity and diet-related non-communicable diseases, globally, public health attention has only relatively recently turned to the links between trade agreements and the nutritional risks associated with it. Specific trade agreements appear to have played an influential role in the volume and types of foods entering different countries, yet there is currently no systematic and objective monitoring of trade agreements for their impacts on food environments. Recently, INFORMAS was set up to monitor and benchmark food environments, government policies and private sector actions within countries and globally. One of its projects/modules focuses on trade policy and in particular the food-related aspects of trade agreements. This paper describes the INFORMAS trade protocol, an approach to collecting food-related information about four domains of trade: trade in goods; trade in services and foreign direct investment; domestic supports, and policy space. Specifically, the protocol is tested in Fiji. The development and testing of this protocol in Fiji represents the first effort to set out a framework and process for objectively monitoring trade agreements and their impacts on national food supply and the wider food environment. It has shown that entry into WTO trade agreements contributed to the nutrition transition in Fiji through the increased availability of imported foods with varying nutritional quality. We observed an increase in imports of both healthy and less healthy foods. The application of the monitoring protocol also highlights challenges for data collection associated with each trade domain that should be considered for future data collection and analysis in other low and middle income countries. © The Author 2017. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  4. Screening for type 2 diabetes in primary care using a stepwise protocol: the Diabscreen study.

    Science.gov (United States)

    Klein Woolthuis, Erwin P; de Grauw, Wim J C; van Gerwen, Willem H E M; van den Hoogen, Henk J M; van de Lisdonk, Eloy H; Metsemakers, Job F M; van Weel, Chris

    2007-12-01

    To evaluate a stepwise protocol in opportunistic screening for type 2 diabetes. From 2000 to 2001, in 11 Dutch general practices (n=49,229) we invited at-risk patients during usual care for a capillary fasting plasma glucose (cFPG1) measurement. If >6.0 mmol/l, a second sample (cFPG2) was taken on another day, followed by a venous sample (vFPG) if cFPG2>6.0 mmol/l and cFPG1 or 2> or =7.0 mmol/l. Of 3724 at-risk patients invited for a cFPG1, 3335 (90%) returned for the measurement. Ultimately, in 125 (4%) of them a vFPG was measured. In 101 out of 125 patients the vFPG was > or =7.0 mmol/l, giving a positive predictive value of our protocol of 81%. A stepwise screening protocol including two subsequent capillary blood glucose measurements from a portable blood glucose meter is well applicable in screening for type 2 diabetes in primary care.

  5. Prevalence of obesity in attention-deficit/hyperactivity disorder: study protocol for a systematic review and meta-analysis

    OpenAIRE

    Cortese, Samuele; Moreira Maia, Carlos Renato; Rohde, Luis Augusto; Morcillo-Peñalver, Carmen; Faraone, Stephen V

    2014-01-01

    Introduction An increasing number of clinical and epidemiological studies suggest a possible association between attention-deficit/hyperactivity disorder (ADHD) and obesity/overweight. However, overall evidence is mixed. Given the public health relevance of ADHD and obesity/overweight, understanding whether and to what extent they are associated is paramount to plan intervention and prevention strategies. We describe the protocol of a systematic review and meta-analysis aimed at assessing the...

  6. Effects of a prehabilitation program on patients? recovery following spinal stenosis surgery: study protocol for a randomized controlled trial

    OpenAIRE

    Marchand, Andr?e-Anne; Suitner, Margaux; O?Shaughnessy, Julie; Ch?tillon, Claude-?douard; Cantin, Vincent; Descarreaux, Martin

    2015-01-01

    Background Degenerative lumbar spinal stenosis is a prevalent condition in adults over the age of 65 and often leads to deconditioning. Although the benefits of surgery outweigh those of conservative approaches, physical rehabilitation may be used to improve function and to minimize the risk of persistent dysfunction. This study protocol was designed to establish the feasibility of a full-scale randomized controlled trial and to assess the efficacy of an active preoperative intervention progr...

  7. Enhancing the early home learning environment through a brief group parenting intervention: study protocol for a cluster randomised controlled trial

    OpenAIRE

    Nicholson, Jan M.; Cann, Warren; Matthews, Jan; Berthelsen, Donna; Ukoumunne, Obioha C.; Trajanovska, Misel; Bennetts, Shannon K.; Hillgrove, Tessa; Hamilton, Victoria; Westrupp, Elizabeth; Hackworth, Naomi J.

    2016-01-01

    Background The quality of the home learning environment has a significant influence on children?s language and communication skills during the early years with children from disadvantaged families disproportionately affected. This paper describes the protocol and participant baseline characteristics of a community-based effectiveness study. It evaluates the effects of ?smalltalk?, a brief group parenting intervention (with or without home coaching) on the quality of the early childhood home l...

  8. Dynamics of sustained use and abandonment of clean cooking systems: study protocol for community-based system dynamics modeling

    OpenAIRE

    Kumar, Praveen; Chalise, Nishesh; Yadama, Gautam N.

    2016-01-01

    Background More than 3 billion of the world?s population are affected by household air pollution from relying on unprocessed solid fuels for heating and cooking. Household air pollution is harmful to human health, climate, and environment. Sustained uptake and use of cleaner cooking technologies and fuels are proposed as solutions to this problem. In this paper, we present our study protocol aimed at understanding multiple interacting feedback mechanisms involved in the dynamic behavior betwe...

  9. Identifying the domains of context important to implementation science: a study protocol.

    Science.gov (United States)

    Squires, Janet E; Graham, Ian D; Hutchinson, Alison M; Michie, Susan; Francis, Jill J; Sales, Anne; Brehaut, Jamie; Curran, Janet; Ivers, Noah; Lavis, John; Linklater, Stefanie; Fenton, Shannon; Noseworthy, Thomas; Vine, Jocelyn; Grimshaw, Jeremy M

    2015-09-28

    There is growing recognition that "context" can and does modify the effects of implementation interventions aimed at increasing healthcare professionals' use of research evidence in clinical practice. However, conceptual clarity about what exactly comprises "context" is lacking. The purpose of this research program is to develop, refine, and validate a framework that identifies the key domains of context (and their features) that can facilitate or hinder (1) healthcare professionals' use of evidence in clinical practice and (2) the effectiveness of implementation interventions. A multi-phased investigation of context using mixed methods will be conducted. The first phase is a concept analysis of context using the Walker and Avant method to distinguish between the defining and irrelevant attributes of context. This phase will result in a preliminary framework for context that identifies its important domains and their features according to the published literature. The second phase is a secondary analysis of qualitative data from 13 studies of interviews with 312 healthcare professionals on the perceived barriers and enablers to their application of research evidence in clinical practice. These data will be analyzed inductively using constant comparative analysis. For the third phase, we will conduct semi-structured interviews with key health system stakeholders and change agents to elicit their knowledge and beliefs about the contextual features that influence the effectiveness of implementation interventions and healthcare professionals' use of evidence in clinical practice. Results from all three phases will be synthesized using a triangulation protocol to refine the context framework drawn from the concept analysis. The framework will then be assessed for content validity using an iterative Delphi approach with international experts (researchers and health system stakeholders/change agents). This research program will result in a framework that identifies the

  10. Weight-loss intervention using implementation intentions and mental imagery: a randomised control trial study protocol.

    Science.gov (United States)

    Hattar, Anne; Hagger, Martin S; Pal, Sebely

    2015-02-27

    Overweight and obesity are major health problems worldwide. This protocol describes the HEALTHI (Healthy Eating and Active LifesTyle Health Intervention) Program, a 12-week randomised-controlled weight-loss intervention that adopts two theory-based intervention techniques, mental imagery and implementation intentions, a behaviour-change technique based on planning that have been shown to be effective in promoting health-behaviour change in previous research. The effectiveness of goal-reminder text messages to augment intervention effects will also be tested. The trial will determine the effects of a brief, low cost, theory-based weight-loss intervention to improve dietary intake and physical activity behaviour and facilitate weight-loss in overweight and obese individuals. Overweight or obese participants will be randomly allocated to one of three conditions: (1) a psycho-education plus an implementation intentions and mental imagery condition; (2) a psycho-education plus an implementation intentions and mental imagery condition with text messages; or (3) a psycho-education control condition. The intervention will be delivered via video presentation to increase the intervention's applicability in multiple contexts and keep costs low. We hypothesise that the intervention conditions will lead to statistically-significant changes in the primary and secondary outcome variables measured at 6 and 12 weeks post-intervention relative to the psycho-education control condition after controlling for baseline values. The primary outcome variable will be body weight and secondary outcome variables will be biomedical (body mass, body fat percentage, muscle mass, waist-hip circumference ratio, systolic and diastolic blood pressure, low-density lipoprotein, high-density lipoprotein, total cholesterol, triglycerides, blood glucose and insulin levels), psychological (quality of life, motivation, risk perception, outcome expectancy, intention, action self-efficacy, maintenance self

  11. Acceptance and commitment therapy for anxious children and adolescents: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Swain, Jessica; Hancock, Karen; Dixon, Angela; Koo, Siew; Bowman, Jenny

    2013-05-15

    Anxiety disorders affect approximately 10% to 20% of young people, can be enduring if left untreated, and have been associated with psychopathology in later life. Despite this, there is a paucity of empirical research to assist clinicians in determining appropriate treatment options. We describe a protocol for a randomized controlled trial in which we will examine the effectiveness of a group-based acceptance and commitment therapy program for children and adolescents with a primary diagnosis of anxiety disorder. For the adolescent participants we will also evaluate the elements of the intervention that act as mechanisms for change. We will recruit 150 young people (90 children and 60 adolescents) diagnosed with an anxiety disorder and their parent or caregiver. After completion of baseline assessment, participants will be randomized to one of three conditions (acceptance and commitment therapy, cognitive behavior therapy or waitlist control). Those in the acceptance and commitment therapy and cognitive behavior therapy groups will receive 10 × 1.5 hour weekly group-therapy sessions using a manualized treatment program, in accordance with the relevant therapy, to be delivered by psychologists. Controls will receive the cognitive behavior therapy program after 10 weeks waitlisted. Repeated measures will be taken immediately post-therapy and at three months after therapy cessation. To the best of our knowledge, this study will be the largest trial of acceptance and commitment therapy in the treatment of children and young people to date. It will provide comprehensive data on the use of acceptance and commitment therapy for anxiety disorders and will offer evidence for mechanisms involved in the process of change. Furthermore, additional data will be obtained for the use of cognitive behavior therapy in this population and this research will illustrate the comparative effectiveness of these two interventions, which are currently implemented widely in contemporary

  12. Study protocol: Evaluating the impact of a rural Australian primary health care service on rural health

    Directory of Open Access Journals (Sweden)

    Buykx Penny

    2011-03-01

    Full Text Available Abstract Background Rural communities throughout Australia are experiencing demographic ageing, increasing burden of chronic diseases, and de-population. Many are struggling to maintain viable health care services due to lack of infrastructure and workforce shortages. Hence, they face significant health disadvantages compared with urban regions. Primary health care yields the best health outcomes in situations characterised by limited resources. However, few rigorous longitudinal evaluations have been conducted to systematise them; assess their transferability; or assess sustainability amidst dynamic health policy environments. This paper describes the study protocol of a comprehensive longitudinal evaluation of a successful primary health care service in a small rural Australian community to assess its performance, sustainability, and responsiveness to changing community needs and health system requirements. Methods/Design The evaluation framework aims to examine the health service over a six-year period in terms of: (a Structural domains (health service performance; sustainability; and quality of care; (b Process domains (health service utilisation and satisfaction; and (c Outcome domains (health behaviours, health outcomes and community viability. Significant international research guided the development of unambiguous reliable indicators for each domain that can be routinely and unobtrusively collected. Data are to be collected and analysed for trends from a range of sources: audits, community surveys, interviews and focus group discussions. Discussion This iterative evaluation framework and methodology aims to ensure the ongoing monitoring of service activity and health outcomes that allows researchers, providers and administrators to assess the extent to which health service objectives are met; the factors that helped or hindered achievements; what worked or did not work well and why; what aspects of the service could be improved and how

  13. Nigerian Journal of Clinical and Counselling Psychology: Submissions

    African Journals Online (AJOL)

    Submission Preparation Checklist. As part of the submission process, authors are required to check off their submission's compliance with all of the following items, and submissions may be returned to authors that do not adhere to these guidelines. The submission has not been previously published, nor is it before another ...

  14. Submission under the United Nations framework convention on climate change and the Kyoto protocol 2011. National inventory report for the German greenhouse gas inventory 1990-2009; Berichterstattung unter der Klimarahmenkonvention der Vereinten Nationen und dem Kyoto-Protokoll 2011. Nationaler Inventarbericht zum Deutschen Treibhausgasinventar 1990-2009

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2011-06-15

    As a Party to the United Nations Framework on Climate Change (UNFCCC), since 1994 Germany has been obliged to prepare, publish and regularly update national emission inventories of greenhouse gases. In February 2005, the Kyoto Protocol entered into force. As a result, for the first time ever the international community of nations is required to implement binding action objectives and instruments for global climate protection. As a result of Europe's own implementation of the Kyoto Protocol, via the adoption of EU Decision 280/20041, these requirements became legally binding for Germany in spring 2004. The Secretariat of the Framework Convention on Climate Change has made submission of the inventory report a pre-requisite for performance of the agreed inventory reviews. Germany now presents its ninth National Inventory Report (NIR 2011), following its inventories for the years 1990 to 2009. This latest report covers the same period (1990 to 2009), and it describes the methods and the data sources on which the calculations are based. The report and the report tables in the Common Reporting Format (CRF) have been prepared in accordance with the UNFCCC guideline on annual inventories (FCCC/SBSTA/2006/9) and, as far as possible, in accordance with the IPCC Good Practice Guidance (IPCC-GPG, 2000) and the IPCC Good Practice Guidance for Land Use, Land Use Change and Forestry (IPCC-GPG LULUCF, 2003). This year, the NIR contains, for the first time, an additional Part II, along with additional sub-chapters in the existing part, in conformance with expanded requirements under the Kyoto Protocol and the relevant decisions at the European level. Part I of the NIR presents, in Chapters 1 to 10, all the information relevant to the annual greenhouse-gas inventory. Chapter 1 provides background information about climate change and about greenhouse gas inventories, as well as further information relative to the Kyoto Protocol. Chapter 2 provides a general overview of

  15. TBI risk stratification at presentation: a prospective study of the incidence and timing of radiographic worsening in the Parkland Protocol.

    Science.gov (United States)

    Phelan, Herb A; Eastman, Alexander L; Madden, Christopher J; Aldy, Kim; Berne, John D; Norwood, Scott H; Scott, William W; Bernstein, Ira H; Pruitt, Jeffrey; Butler, Gordon; Rogers, Lowery; Minei, Joseph P

    2012-08-01

    We have created a theoretical algorithm for venous thromboembolism prophylaxis after traumatic brain injury (TBI) known as the Parkland Protocol, which stratifies patients into low-, medium-, and high-risk categories for spontaneous progression of hemorrhage. This prospective study characterizes the incidence and timing of radiographic progression of the TBI patterns in these categories. Inclusion criterion was presentation with intracranial blood between February 2010 and March 2011; exclusion was receipt of only one computed tomographic scan of the head during the inpatient stay or preinjury warfarin. At admission, all patients were preliminarily categorized per the Parkland Protocol as follows: low risk (LR), patients meeting the modified Berne-Norwood criteria; moderate risk (MR), injuries larger than the modified Berne-Norwood criteria without requiring a neurosurgical procedure; high risk (HR), any patient with a craniotomy/monitor. A total of 245 patients with intracranial hemorrhage were enrolled during the 13-month study period. Of patients preliminarily classified as LR at admission (n = 136), progression was seen in 25.0%. Spontaneous worsening was seen in 7.4% of LR patients at 24 hours after injury, and no LR patients progressed at 72 hours after injury. In patients initially classified as MR at admission (n = 42), progression was seen in 42.9%, with 91.5% of patients demonstrating stable computed tomographic head scans at 72 hours after injury. In patients initially classified as HR (n = 67), 64.2% demonstrated spontaneous progression of their TBI patterns, with 10.5% continuing to progress at 72 hours after injury. Most repeat scans were performed as routinely scheduled studies (81-91%). Increases in the incidence of spontaneous worsening were seen as severities of injury progressed from the Parkland Protocol's LR to MR to HR arms. The time frames for these spontaneous worsenings seem to be such that the protocol's theoretical recommendations for

  16. A cohort study of the recovery of health and wellbeing following colorectal cancer (CREW study: protocol paper

    Directory of Open Access Journals (Sweden)

    Fenlon Deborah

    2012-04-01

    Full Text Available Abstract Background The number of people surviving colorectal cancer has doubled in recent years. While much of the literature suggests that most people return to near pre-diagnosis status following surgery for colorectal cancer, this literature has largely focused on physical side effects. Longitudinal studies in colorectal cancer have either been small scale or taken a narrow focus on recovery after surgery. There is a need for a comprehensive, long-term study exploring all aspects of health and wellbeing in colorectal cancer patients. The aim of this study is to establish the natural history of health and wellbeing in people who have been treated for colorectal cancer. People have different dispositions, supports and resources, likely resulting in individual differences in restoration of health and wellbeing. The protocol described in this paper is of a study which will identify who is most at risk of problems, assess how quickly people return to a state of subjective health and wellbeing, and will measure factors which influence the course of recovery. Methods/design This is a prospective, longitudinal cohort study following 1000 people with colorectal cancer over a period of two years, recruiting from 30 NHS cancer treatment centres across the UK. Questionnaires will be administered prior to surgery, and 3, 9, 15 and 24 months after surgery, with the potential to return to this cohort to explore on-going issues related to recovery after cancer. Discussion Outcomes will help inform health care providers about what helps or hinders rapid and effective recovery from cancer, and identify areas for intervention development to aid this process. Once established the cohort can be followed up for longer periods and be approached to participate in related projects as appropriate and subject to funding.

  17. Training conversation partners of persons with communication disorders related to Parkinson's disease--a protocol and a pilot study.

    Science.gov (United States)

    Forsgren, Emma; Antonsson, Malin; Saldert, Charlotta

    2013-07-01

    This paper reports on the adaptation of a training programme for conversation partners of persons with Parkinson's disease, and a protocol for assessment of possible changes in conversational interaction as a result of intervention. We present data from an explorative multiple case study with three individuals with Parkinson's disease and their spouses. Repeated analysis of natural conversational interaction and measures of the participants' perception of communication as well as measures of different cognitive abilities were obtained. The results show that the communication in all three dyads was affected by both speech and language problems and that the conversation training model and the assessment protocol may work well after minor adjustments. Influence of different aspects of cognition on communication is discussed.

  18. Study protocol for the FITR Heart Study: Feasibility, safety, adherence, and efficacy of high intensity interval training in a hospital-initiated rehabilitation program for coronary heart disease

    Directory of Open Access Journals (Sweden)

    Jenna Taylor

    2017-12-01

    Conclusions: This study aims to address the ongoing concerns regarding the practicality and safety of HIIT in CR programs. We anticipate study findings will lead to the development of a standardized protocol to facilitate CR programs to incorporate HIIT as a standard exercise option for appropriate patients.

  19. Better movers and thinkers (BMT: A quasi-experimental study into the impact of physical education on children's cognition—A study protocol

    Directory of Open Access Journals (Sweden)

    Andrew Dalziell

    2015-01-01

    This protocol provides the details of the rationale and design of the study and details of the intervention, outcome measures, and the recruitment process. The study will address gaps within current research by evaluating if a change of approach in the delivery of PE within schools has an effect on children's cognition, PA habits, and GMC within a Scottish setting.

  20. The FLASSH study: protocol for a randomised controlled trial evaluating falls prevention after stroke and two sub-studies

    Directory of Open Access Journals (Sweden)

    Mackintosh Shylie F

    2009-03-01

    Full Text Available Abstract Background Falls are common in stroke survivors returning home after rehabilitation, however there is currently a lack of evidence about preventing falls in this population. This paper describes the study protocol for the FLASSH (FaLls prevention After Stroke Survivors return Home project. Methods and design This randomised controlled trial aims to evaluate the effectiveness of a multi-factorial falls prevention program for stroke survivors who are at high risk of falling when they return home after rehabilitation. Intervention will consist of a home exercise program as well as individualised falls prevention and injury minimisation strategies based on identified risk factors for falls. Additionally, two sub-studies will be implemented in order to explore other key areas related to falls in this population. The first of these is a longitudinal study evaluating the relationship between fear of falling, falls and function over twelve months, and the second evaluates residual impairment in gait stability and obstacle crossing twelve months after discharge from rehabilitation. Discussion The results of the FLASSH project will inform falls prevention practice for stroke survivors. If the falls prevention program is shown to be effective, low cost strategies to prevent falls can be implemented for those at risk around the time of discharge from rehabilitation, thus improving safety and quality of life for stroke survivors. The two sub-studies will contribute to the overall understanding and management of falls risk in stroke survivors. Trial registration This trial is registered with the Australian and New Zealand Clinical Trials Registry (ACTRN012607000398404.

  1. PANSAID - PAracetamol and NSAID in combination: study protocol for a randomised trial.

    Science.gov (United States)

    Thybo, Kasper Højgaard; Hägi-Pedersen, Daniel; Wetterslev, Jørn; Dahl, Jørgen Berg; Schrøder, Henrik Morville; Bülow, Hans Henrik; Bjørck, Jan Gottfrid; Mathiesen, Ole

    2017-01-10

    2017 and manuscript submission ultimo 2017. EudraCT: 2015-002239-16 (12/8-15); ClinicalTrials.gov: NCT02571361 . Registered on 7 October 2015.

  2. The effect of standardised implantoplasty protocol on titanium surface roughness: an in-vitro study.

    Science.gov (United States)

    Tawse-Smith, Andrew; Kota, Akash; Jayaweera, Yathen; Vuuren, Wendy Jansen van; Ma, Sunyoung

    2016-12-22

    To analyse the changes of surface characteristics of machined and moderately roughened titanium disks following a standardised implantoplasty protocol. Forty titanium discs (machined: n = 20; moderately roughened: n = 20) were instrumented with one half of each disc maintained as the control (non-instrumented). The standardised implantoplasty protocol was carried out using a custom jig with the sequential change of burs: 1) Regular grit diamond [10s], 2) Super-fine grit diamond [10s], 3) Brownie(tm) silicone polisher [15s], 4) Greenie(tm) silicone polisher [15s]. Surface topography was analysed using confocal laser scanning microscopy (CLSM) and scanning electron microscopy (SEM). Energy dispersive x-ray spectroscopy (EDS) was used to measure the elemental profiles of each disc. Quantitative analysis showed similar changes in level of roughness between the machined and moderately roughened titanium discs. CLSM demonstrated an increased roughness (Ra and Sa values) after polishing with a regular grit diamond bur when compared to the uninstrumented surfaces. Although the roughness decreased after the further polishing with the super-fine grit diamond bur, subsequent instrumentation using silicon burs tended to increase the roughness, albeit being statistically insignificant. There was a residue of silicon particles despite the irrigation after each polishing stage. The proposed implantoplasty protocol did not achieve a sufficient level of smoothness on the machined or moderately roughened titanium surfaces when compared to the Ra threshold. Further research is recommended to test the efficacy of each bur on titanium surfaces with longer duration using actual oral implants to allow better comparison.

  3. The effect of standardised implantoplasty protocol on titanium surface roughness: an in-vitro study

    Directory of Open Access Journals (Sweden)

    Andrew TAWSE-SMITH

    Full Text Available Abstract: To analyse the changes of surface characteristics of machined and moderately roughened titanium disks following a standardised implantoplasty protocol. Forty titanium discs (machined: n = 20; moderately roughened: n = 20 were instrumented with one half of each disc maintained as the control (non-instrumented. The standardised implantoplasty protocol was carried out using a custom jig with the sequential change of burs: 1 Regular grit diamond [10s], 2 Super-fine grit diamond [10s], 3 Brownie(tm silicone polisher [15s], 4 Greenie(tm silicone polisher [15s]. Surface topography was analysed using confocal laser scanning microscopy (CLSM and scanning electron microscopy (SEM. Energy dispersive x-ray spectroscopy (EDS was used to measure the elemental profiles of each disc. Quantitative analysis showed similar changes in level of roughness between the machined and moderately roughened titanium discs. CLSM demonstrated an increased roughness (Ra and Sa values after polishing with a regular grit diamond bur when compared to the uninstrumented surfaces. Although the roughness decreased after the further polishing with the super-fine grit diamond bur, subsequent instrumentation using silicon burs tended to increase the roughness, albeit being statistically insignificant. There was a residue of silicon particles despite the irrigation after each polishing stage. The proposed implantoplasty protocol did not achieve a sufficient level of smoothness on the machined or moderately roughened titanium surfaces when compared to the Ra threshold. Further research is recommended to test the efficacy of each bur on titanium surfaces with longer duration using actual oral implants to allow better comparison.

  4. Effects and feasibility of an exercise intervention for individuals living with dementia in nursing homes: study protocol.

    Science.gov (United States)

    Brett, Lindsey; Traynor, Victoria; Stapley, Paul; Meedya, Shahla

    2017-09-01

    Worldwide, there are an estimated 35.6 million individuals living with dementia. It is important that non-pharmacological therapies are utilized to help manage the symptoms of dementia, such as agitation, as they are the recommended first approach in best practice guidelines. This protocol outlines a randomized controlled trial with a qualitative component which evaluated the effects and feasibility of a physical therapist-led physical exercise intervention on agitation of individuals living with dementia in nursing homes. Physical performance levels were considered as a secondary outcome. This evidence-based protocol consisted of a range of adaptable physical exercises that targeted strength, balance, endurance, and flexibility. To help determine the optimum parameters for this population group, the study used two intervention groups: (a) physical exercise intervention for 45 minutes once a week; (b) physical exercise intervention for 15 minutes three times a week (total time also 45 minutes per week). Both intervention groups were compared to a control group, which continued to participate in usual care only (no specific physical exercise intervention), such as basic seated exercise class, carpet bowls, and "armchair" activities. The physical therapist-led physical exercise intervention detailed in this protocol could be integrated into dementia care in nursing homes or other similar settings to help reduce agitation and improve physical performance.

  5. Developing a comprehensive presurgical functional MRI protocol for patients with intractable temporal lobe epilepsy: a pilot study

    Energy Technology Data Exchange (ETDEWEB)

    Deblaere, K.; Vandemaele, P.; Achten, E. [MRI Department -1 K12, Department of Radiology, Ghent University Hospital, De Pintelaan 185, 9000 Ghent (Belgium); Backes, W.H.; Hofman, P.; Wilmink, J. [Department of Neuroradiology, University Hospital Maastricht, Postbus 5800, 6202 AZ Maastricht (Netherlands); Boon, P.A.; Vonck, K. [Department of Neurology, Ghent University Hospital, De Pintelaan 185, 9000 Ghent (Belgium); Boon, P. [Department of Medical Psychology, University Hospital Maastricht (Netherlands); Troost, J. [Department of Neurology, University Hospital Maastricht (Netherlands); Vermeulen, J. [S.E.I.N Heemstede, Psychological Laboratory, Achterweg 5, 2103 SW Heemstede (Netherlands); Aldenkamp, A. [Epilepsy Center ' Kempenhaeghe' , Postbus 61, 5900 AB Heeze (Netherlands)

    2002-08-01

    Our aim was to put together and test a comprehensive functional MRI (fMRI) protocol which could compete with the intracarotid amytal (IAT) or Wada test for the localisation of language and memory function in patients with intractable temporal lobe epilepsy. The protocol was designed to be performed in under 1 h on a standard 1.5 tesla imager. We used five paradigms to test nine healthy right-handed subjects: complex scene-encoding, picture-naming, reading, word-generation and semantic-decision tasks. The combination of these tasks generated two activation maps related to memory in the mesial temporal lobes, and three language-related maps of activation in a major part of the known language network. The functional maps from the encoding and naming tasks showed typical and symmetrical posterior mesial temporal lobe activation related to memory in all subjects. Only four of nine subjects also showed symmetrical anterior hippocampal activation. Language lateralisation was best with the word generation and reading paradigms and proved possible in all subjects. The reading paradigm enables localisation of language function in the left anterior temporal pole and middle temporal gyrus, areas typically resected during epilepsy surgery. The combined results of this comprehensive f MRI protocol are adequate for a comparative study with the IAT in patients with epilepsy being assessed for surgery. (orig.)

  6. Clean Development Mechanism” projects in the developing countries within the Kyoto protocol: problem analysis of a case study in Morocco

    Directory of Open Access Journals (Sweden)

    Gaglioppa P

    2009-11-01

    Full Text Available An internship period spent in the north of Morocco kingdom (Tetouan gave a contribute to the organization activity in promoting sustainable development in the rural areas under the Kyoto Protocol. The multitasking project will increase biodiversity planting trees for wood, forage and fruits productions. The paper show a first step study to evaluate the possibility to reach an agreement with the propriety and the manager of these areas in a multifunctional reforestation project. The eligible site suitable for reforestation in accordance with the CDM international scheme is a large plateau (more than 5000 hectares 600 meters high on the sea level far from the Cannabis crops area. The evaluation of the project costs and of the social benefits for the population consider (using different species the indigenous communities necessity. The evaluation of carbon sequestration show the small scale of the reforestation project on behalf of the Kyoto Protocol, but give also an idea about the people rights and necessities. The normal afforestation and reforestation projects, under the Kyoto Protocol, try to maximize the CO2 sequestration in a short time, than business laws usually require. A small scale project could be self-managing, less expensive (international certification costs and more interesting for local communities.

  7. Docking studies on DNA-ligand interactions: building and application of a protocol to identify the binding mode.

    Science.gov (United States)

    Ricci, Clarisse G; Netz, Paulo A

    2009-08-01

    Despite DNA being an important target for several drugs, most of the docking programs are validated only for proteins and their ligands. In this paper, we used AutoDock 4.0 to perform self-dockings and cross dockings between two DNA ligands (a minor groove binder and an intercalator) and four distinct receptors: 1) crystallographic DNA without intercalation gap; 2) crystallographic DNA with intercalation gap; 3) canonical B-DNA; and 4) modified B-DNA with intercalation gap. Besides being efficient in self-dockings, AutoDock is capable of correctly identifying two of the main DNA binding modes with the condition that the target possesses an artificial intercalation gap. Therefore, we suggest a default protocol to identify DNA binding modes which uses a modified canonical DNA (with gap) as receptor. This protocol was applied to dock two different Troger bases to DNA and the predicted binding modes agree with those suggested, yet not established, by experimental data. We also applied the protocol to dock aflatoxin B(1) exo-8,9-epoxide, and the results are in complete agreement with experimental data from the literature. We propose that this approach can be used to investigate other ligands whose binding mode to DNA remains unknown, yielding a suitable starting point for further theoretical studies such as molecular dynamics simulations.

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

    Science.gov (United States)

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

    2014-01-01

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

  9. Assessment of Adverse Events in Protocols, Clinical Study Reports, and Published Papers of Trials of Orlistat: A Document Analysis.

    Directory of Open Access Journals (Sweden)

    Jeppe Bennekou Schroll

    2016-08-01

    Full Text Available Little is known about how adverse events are summarised and reported in trials, as detailed information is usually considered confidential. We have acquired clinical study reports (CSRs from the European Medicines Agency through the Freedom of Information Act. The CSRs describe the results of studies conducted as part of the application for marketing authorisation for the slimming pill orlistat. The purpose of this study was to study how adverse events were summarised and reported in study protocols, CSRs, and published papers of orlistat trials.We received the CSRs from seven randomised placebo controlled orlistat trials (4,225 participants submitted by Roche. The CSRs consisted of 8,716 pages and included protocols. Two researchers independently extracted data on adverse events from protocols and CSRs. Corresponding published papers were identified on PubMed and adverse event data were extracted from this source as well. All three sources were compared. Individual adverse events from one trial were summed and compared to the totals in the summary report. None of the protocols or CSRs contained instructions for investigators on how to question participants about adverse events. In CSRs, gastrointestinal adverse events were only coded if the participant reported that they were "bothersome," a condition that was not specified in the protocol for two of the trials. Serious adverse events were assessed for relationship to the drug by the sponsor, and all adverse events were coded by the sponsor using a glossary that could be updated by the sponsor. The criteria for withdrawal due to adverse events were in one case related to efficacy (high fasting glucose led to withdrawal, which meant that one trial had more withdrawals due to adverse events in the placebo group. Finally, only between 3% and 33% of the total number of investigator-reported adverse events from the trials were reported in the publications because of post hoc filters, though six of

  10. Static balance and function in children with cerebral palsy submitted to neuromuscular block and neuromuscular electrical stimulation: study protocol for prospective, randomized, controlled trial

    National Research Council Canada - National Science Library

    Kazon, Soráia; Grecco, Luanda A C; Pasini, Hugo; Corrêa, João C F; Christovão, Thaluanna C L; de Carvalho, Paulo de Tarsocamillo; Giannasi, Lilian Chrystiane; Lucareli, Paulo R G; de Oliveira, Luis Vicente Franco; Salgado, Afonso Shiguemi Inoue; Sampaio, Luciana M M; Oliveira, Claudia S

    2012-01-01

    .... The aim of the present study is to describe a protocol for a study aimed at analyzing the effects of NMES on dorsiflexors combined with physical therapy on static and functional balance in children...

  11. Clinical outcomes and mortality before and after implementation of a pediatric sepsis protocol in a limited resource setting: A retrospective cohort study in Bangladesh.

    Science.gov (United States)

    Kortz, Teresa Bleakly; Axelrod, David M; Chisti, Mohammod J; Kache, Saraswati

    2017-01-01

    Pediatric sepsis has a high mortality rate in limited resource settings. Sepsis protocols have been shown to be a cost-effective strategy to improve morbidity and mortality in a variety of populations and settings. At Dhaka Hospital in Bangladesh, mortality from pediatric sepsis in high-risk children previously approached 60%, which prompted the implementation of an evidenced-based protocol in 2010. The clinical effectiveness of this protocol had not been measured. We hypothesized that implementation of a pediatric sepsis protocol improved clinical outcomes, including reducing mortality and length of hospital stay. This was a retrospective cohort study of children 1-59 months old with a diagnosis of sepsis, severe sepsis or septic shock admitted to Dhaka Hospital from 10/25/2009-10/25/2011. The primary outcome was inpatient mortality pre- and post-protocol implementation. Secondary outcomes included fluid overload, heart failure, respiratory insufficiency, length of hospital stay, and protocol compliance, as measured by antibiotic and fluid bolus administration within 60 minutes of hospital presentation. 404 patients were identified by a key-word search of the electronic medical record; 328 patients with a primary diagnosis of sepsis, severe sepsis, or septic shock were included (143 pre- and185 post-protocol) in the analysis. Pre- and post-protocol mortality were similar and not statistically significant (32.17% vs. 34.59%, p = 0.72). The adjusted odds ratio (AOR) for post-protocol mortality was 1.55 (95% CI, 0.88-2.71). The odds for developing fluid overload were significantly higher post-protocol (AOR 3.45, 95% CI, 2.04-5.85), as were the odds of developing heart failure (AOR 4.52, 95% CI, 1.43-14.29) and having a longer median length of stay (AOR 1.81, 95% CI 1.10-2.96). There was no statistically significant difference in respiratory insufficiency (pre- 65.7% vs. post- 70.3%, p = 0.4) or antibiotic administration between the cohorts (pre- 16.08% vs. post- 12

  12. Clinical outcomes and mortality before and after implementation of a pediatric sepsis protocol in a limited resource setting: A retrospective cohort study in Bangladesh.

    Directory of Open Access Journals (Sweden)

    Teresa Bleakly Kortz

    Full Text Available Pediatric sepsis has a high mortality rate in limited resource settings. Sepsis protocols have been shown to be a cost-effective strategy to improve morbidity and mortality in a variety of populations and settings. At Dhaka Hospital in Bangladesh, mortality from pediatric sepsis in high-risk children previously approached 60%, which prompted the implementation of an evidenced-based protocol in 2010. The clinical effectiveness of this protocol had not been measured. We hypothesized that implementation of a pediatric sepsis protocol improved clinical outcomes, including reducing mortality and length of hospital stay.This was a retrospective cohort study of children 1-59 months old with a diagnosis of sepsis, severe sepsis or septic shock admitted to Dhaka Hospital from 10/25/2009-10/25/2011. The primary outcome was inpatient mortality pre- and post-protocol implementation. Secondary outcomes included fluid overload, heart failure, respiratory insufficiency, length of hospital stay, and protocol compliance, as measured by antibiotic and fluid bolus administration within 60 minutes of hospital presentation.404 patients were identified by a key-word search of the electronic medical record; 328 patients with a primary diagnosis of sepsis, severe sepsis, or septic shock were included (143 pre- and185 post-protocol in the analysis. Pre- and post-protocol mortality were similar and not statistically significant (32.17% vs. 34.59%, p = 0.72. The adjusted odds ratio (AOR for post-protocol mortality was 1.55 (95% CI, 0.88-2.71. The odds for developing fluid overload were significantly higher post-protocol (AOR 3.45, 95% CI, 2.04-5.85, as were the odds of developing heart failure (AOR 4.52, 95% CI, 1.43-14.29 and having a longer median length of stay (AOR 1.81, 95% CI 1.10-2.96. There was no statistically significant difference in respiratory insufficiency (pre- 65.7% vs. post- 70.3%, p = 0.4 or antibiotic administration between the cohorts (pre- 16.08% vs

  13. Pemanfaatan Jaringan Komputer Untuk Aplikasi IPTV (Internet Protocol Television Studi Kasus Akatel Sandhy Putra Purwokerto

    Directory of Open Access Journals (Sweden)

    Galih Sasmi Ramdhani

    2010-11-01

    Full Text Available Internet Protocol Television (IPTV adalah suatu pengembangan baru dalam software komunikasi client-server yang mem-broadcast video yang berkualitas tinggi melalui jaringan internet protocol. IPTV melayani baik siaran langsung (live maupun program atau video yang tersimpan di server. Streaming adalah sebuah teknologi untuk memainkan file video atau audio secara langsung ataupun dengan prerecorded dari sebuah mesin server. File video atau audio  yang terletak pada server dapat secara langsung dijalankan pada komputer client sesaat setelah ada permintaan dari users sehingga proses download yang menghabiskan waktu cukup lama dapat dihindari. Digital Video Broadcasting (DVB adalah salah satu sistem yang digunakan untuk mentransmisikan siaran TV / Video digital hingga sampai ke pengguna akhir (end-user. Proses Transmisi siaran TV umumnya masih menggunakan metode analog, maka dengan adanya streaming TV channel berbasis DVB merupakan suatu perkembangan distribusi siaran televisi yang tadinya secara analog menjadi digital. Oleh karena itu pada penelitian ini akan dibahas mengenai aplikasi IPTV yang berbasis DVB dengan metode streaming pada Ubuntu 9.04 yang merupakan distro Linux dengan media transmisi Wireless LAN Akatel Sandhy Putra Purwokerto. Metode streaming yang digunakan adalah broadcast yaitu pengiriman data, dimana data dikirimkan ke banyak titik sekaligus, tanpa melakukan pengecekan apakah titik tersebut siap atau tidak, atau tanpa memperhatikan apakah data itu sampai atau tidak. Contoh penggunaan sistem ini adalah siaran televisi dan radio.

  14. Preoperative vestibular assessment protocol of cochlear implant surgery: an analytical descriptive study.

    Science.gov (United States)

    Bittar, Roseli Saraiva Moreira; Sato, Eduardo Setsuo; Ribeiro, Douglas Jósimo Silva; Tsuji, Robinson Koji

    Cochlear implants are undeniably an effective method for the recovery of hearing function in patients with hearing loss. To describe the preoperative vestibular assessment protocol in subjects who will be submitted to cochlear implants. Our institutional protocol provides the vestibular diagnosis through six simple tests: Romberg and Fukuda tests, assessment for spontaneous nystagmus, Head Impulse Test, evaluation for Head Shaking Nystagmus and caloric test. 21 patients were evaluated with a mean age of 42.75±14.38 years. Only 28% of the sample had all normal test results. The presence of asymmetric vestibular information was documented through the caloric test in 32% of the sample and spontaneous nystagmus was an important clue for the diagnosis. Bilateral vestibular areflexia was present in four subjects, unilateral arreflexia in three and bilateral hyporeflexia in two. The Head Impulse Test was a significant indicator for the diagnosis of areflexia in the tested ear (p=0.0001). The sensitized Romberg test using a foam pad was able to diagnose severe vestibular function impairment (p=0.003). The six clinical tests were able to identify the presence or absence of vestibular function and function asymmetry between the ears of the same individual. Copyright © 2016 Associação Brasileira de Otorrinolaringologia e Cirurgia Cérvico-Facial. Published by Elsevier Editora Ltda. All rights reserved.

  15. Preoperative vestibular assessment protocol of cochlear implant surgery: an analytical descriptive study

    Directory of Open Access Journals (Sweden)

    Roseli Saraiva Moreira Bittar

    Full Text Available Abstract Introduction: Cochlear implants are undeniably an effective method for the recovery of hearing function in patients with hearing loss. Objective: To describe the preoperative vestibular assessment protocol in subjects who will be submitted to cochlear implants. Methods: Our institutional protocol provides the vestibular diagnosis through six simple tests: Romberg and Fukuda tests, assessment for spontaneous nystagmus, Head Impulse Test, evaluation for Head Shaking Nystagmus and caloric test. Results: 21 patients were evaluated with a mean age of 42.75 ± 14.38 years. Only 28% of the sample had all normal test results. The presence of asymmetric vestibular information was documented through the caloric test in 32% of the sample and spontaneous nystagmus was an important clue for the diagnosis. Bilateral vestibular areflexia was present in four subjects, unilateral arreflexia in three and bilateral hyporeflexia in two. The Head Impulse Test was a significant indicator for the diagnosis of areflexia in the tested ear (p = 0.0001. The sensitized Romberg test using a foam pad was able to diagnose severe vestibular function impairment (p = 0.003. Conclusion: The six clinical tests were able to identify the presence or absence of vestibular function and function asymmetry between the ears of the same individual.

  16. Reduction of bladder activity on FDG PET/CT scan in patients with urinary bladder carcinoma. A prospective study with a patient-friendly protocol.

    Science.gov (United States)

    Tsai, S-C; Ou, Y-C; Cheng, C-L; Li, J-R; Lin, Y-C; Ho, H-C; Chiu, K-Y; Su, C-K; Lin, W-Y

    2015-01-01

    Oral hydration with large volume of fluid, high dose of diuretics and maximum bladder distension are frequently required to achieve an adequate urinary FDG clearance in an FDG PET/CT protocol for bladder cancer or pelvic tumour evaluation. Although most patients tolerated these procedures for eliminating urinary FDG activity, these procedures may be still unpleasant. Is there a more patient-friendly protocol which is less burdensome and yet provides a satisfactory FDG clearance in urine? In this study, we established a patient-friendly FDG PET/CT protocol without compromising urinary FDG clearance. 23 patients with biopsy-proven urinary bladder cancers were recruited to evaluate the effectiveness of this patient-friendly protocol on reducing urinary bladder FDG activity. The patient-friendly protocol includes encouraging patients to take a tolerable amount of fluid, delaying the administration of low dose diuretic, shortening the urine holding time and using delayed imaging. All of the patients tolerated this patient-friendly procedure well. In addition, the patient-friendly protocol was effective in reducing FDG activity in the urine. One hundred percent of primary bladder cancer were visualized on the FDG PET/CT images using this patient-friendly protocol. This patient-friendly FDG PET/CT protocol is less intrusive yet effective in reducing urinary FDG activity.

  17. Study protocol--Indigenous Australian social networks and the impact on smoking policy and programs in Australia: protocol for a mixed-method prospective study.

    Science.gov (United States)

    Maddox, Raglan; Davey, Rachel; Cochrane, Tom; Lovett, Ray; van der Sterren, Anke

    2013-09-24

    Tobacco use is the most preventable cause of morbidity and mortality in Australia. Comprehensive tobacco control has reduced smoking rates in Australia from approximately 34 per cent in 1980 to 15 per cent in 2010. However, 46 per cent of Aboriginal and Torres Strait Islander people (Indigenous Australians) smoke on a daily basis, more than double the rate of non-Indigenous Australians. The evidence of effective tobacco control strategies for Indigenous Australians is relatively scarce. The aim of this study is to (i) explore the influences of smoking in Indigenous Australian people and to (ii) help inform and evaluate a multi-component tobacco control strategy. The study aims to answer the following questions:--do individuals' social networks influence smoking behaviours;--is there an association between various social and cultural factors and being a smoker or non-smoker; and--does a multi-component tobacco control program impact positively on tobacco behaviours, attitudes and beliefs in Indigenous Australians. Our prospective study will use a mixed-method approach (qualitative and quantitative), including a pre- and post-test evaluation of a tobacco control initiative. The study will explore the social and cultural context underlying Indigenous Australian tobacco use and associated factors which influence smoking behaviour. Primary data will be collected via a panel survey, interviews and focus groups. Secondary data will include de-identified PBS items related to smoking and also data collected from the Quitlines call service. Network analysis will be used to assess whether social networks influence smoking behaviours. For the survey, baseline differences will be tested using chi(2) statistics for the categorical and dichotomous variables and t-tests for the continuous variables, where appropriate. Grounded theory will be used to analyse the interviews and focus groups. Local Aboriginal community controlled organisations will partner in the study. Our study

  18. 78 FR 43215 - Submission for OMB review; 30-day Comment Request: The Agricultural Health Study: A Prospective...

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    2013-07-19

    ... Agricultural Health Study: A Prospective Cohort Study of Cancer and Other Disease Among Men and Women in..., 111 T.W. Alexander Drive, PO Box 12233, MD A3-05, Research Triangle Park, NC 27709, or call non-toll...: The Agricultural Health Study: A Prospective Cohort Study of Cancer and Other Disease Among Men and...

  19. 77 FR 50674 - Submission for OMB Review; Comment Request

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    2012-08-22

    ...; ] DEPARTMENT OF AGRICULTURE Submission for OMB Review; Comment Request August 17, 2012. The Department of..., FNS needs to examine the reasons behind the shopping decision at farmers' markets among recipients of... Information: The objectives of this study are to: (1) Understand the shopping patterns of the SNAP...

  20. 76 FR 2645 - Submission for OMB Review; Comment Request

    Science.gov (United States)

    2011-01-14

    ... purposes: (1) To fund feasibility studies, marketing and business plans, and similar development activities... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF AGRICULTURE Submission for OMB Review; Comment Request The Department of Agriculture has submitted the following...

  1. Problem-solving in caregiver-counselling (PLiP Study): study protocol of a cluster randomized pragmatic trial.

    Science.gov (United States)

    Pfeiffer, Klaus; Hautzinger, Martin; Patak, Margarete; Grünwald, Julia; Becker, Clemens; Albrecht, Diana

    2017-03-06

    Despite the positive evaluation of various caregiver interventions over the past 3 decades, only very few intervention protocols have been translated to delivery in service contexts. The purpose of this study is to train care counsellors of statutory long term care insurances in problem-solving and to evaluate this approach as an additional component in the statutory care counselling in Germany. A pragmatic cluster randomized controlled trial in which 38 sites with 58 care counsellors are randomly assigned to provide either routine counselling plus additional problem-solving for caregivers or routine counselling alone. The counsellor training comprises an initial 2-day training, a follow-up day after 4 months, and biweekly supervision contacts with a psychotherapist for 6 months over the phone. The agreed minimum counselling intensity is one initial face-to-face contact including a caregiver assessment and at least one telephone follow-up contact. Caregivers who are positively screened for significant strain in their role are followed up at 3 and 6 months after baseline assessment. Main outcome are caregivers' depressive symptoms. While it is unclear if the expected very low amount of additional counselling time is sufficient to yield any additional effects on caregiver depression, it is also unclear if the additional problem-solving component yields to synergies with routine counselling that is based on information and case management. There are different potential individual and organisational barriers to a consistent intervention delivery like gratification for participation, time for extra work or internal motivation to participate. ( ISRCTN23635523 ).

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

    Directory of Open Access Journals (Sweden)

    Weggelaar Anne-Marie

    2011-10-01

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

  3. Assessment of Adverse Events in Protocols, Clinical Study Reports, and Published Papers of Trials of Orlistat

    DEFF Research Database (Denmark)

    Schroll, Jeppe Bennekou; Penninga, Elisabeth I; Gøtzsche, Peter C

    2016-01-01

    adverse events. In CSRs, gastrointestinal adverse events were only coded if the participant reported that they were "bothersome," a condition that was not specified in the protocol for two of the trials. Serious adverse events were assessed for relationship to the drug by the sponsor, and all adverse......,318 adverse events that were not listed or mentioned in the CSR itself but could be identified through manually counting individual adverse events reported in an appendix. We discovered that the majority of patients had multiple episodes of the same adverse event that were only counted once, though...... this was not described in the CSRs. We also discovered that participants treated with orlistat experienced twice as many days with adverse events as participants treated with placebo (22.7 d versus 14.9 d, p-value Student's t test). Furthermore, compared with the placebo group, adverse events in the orlistat...

  4. Acupuncture for Symptom Relief in Palliative Care—Study Protocol and Semistandardized Treatment Schemes

    Directory of Open Access Journals (Sweden)

    Sybille Kramer

    2017-08-01

    Full Text Available The use of complementary and alternative medicine methods such as acupuncture in palliative care has increased over the past years. Well-planned trials are warranted to show its effectiveness in relieving distressing symptoms. The development of treatment schemes to be used in the trial for both acupuncture and medical symptom control is challenging, as both acupuncture and palliative care are highly individualized. Thus, standardized care plans of a randomized controlled trial will have difficulties in producing treatment results that compare to the clinical practice. As an alternative, treatment protocols for both acupuncture and medical symptom control of dyspnea, pruritus, hypersalivation, depression, anxiety, and xerostomia were designed with the input of experts. They are designed to provide sufficient symptom control and comparability for a three-arm, randomized controlled trial. Medical symptom control will be provided to all groups. The two control groups will be medical treatment and sham-laser acupuncture.

  5. Acupuncture for Symptom Relief in Palliative Care-Study Protocol and Semistandardized Treatment Schemes.

    Science.gov (United States)

    Kramer, Sybille; Irnich, Dominik; Lorenzl, Stefan

    2017-08-01

    The use of complementary and alternative medicine methods such as acupuncture in palliative care has increased over the past years. Well-planned trials are warranted to show its effectiveness in relieving distressing symptoms. The development of treatment schemes to be used in the trial for both acupuncture and medical symptom control is challenging, as both acupuncture and palliative care are highly individualized. Thus, standardized care plans of a randomized controlled trial will have difficulties in producing treatment results that compare to the clinical practice. As an alternative, treatment protocols for both acupuncture and medical symptom control of dyspnea, pruritus, hypersalivation, depression, anxiety, and xerostomia were designed with the input of experts. They are designed to provide sufficient symptom control and comparability for a three-arm, randomized controlled trial. Medical symptom control will be provided to all groups. The two control groups will be medical treatment and sham-laser acupuncture. Copyright © 2017. Published by Elsevier B.V.

  6. 7 CFR 400.705 - Contents required for a new submission or changes to a previously approved submission.

    Science.gov (United States)

    2010-01-01

    ... reinsured under the Act; (5) Focus group results; (6) Market research studies; (7) Qualitative market... any causes of loss excluded; (6) Any statements to be included in the actuarial documents; and (7) The... performance of the submission under various scenarios depicting good and poor actuarial experience; and (6) A...

  7. Building a protocol expressway: the case of Mayo Clinic Cancer Center.

    Science.gov (United States)

    McJoynt, Terre A; Hirzallah, Muhanad A; Satele, Daniel V; Pitzen, Jason H; Alberts, Steven R; Rajkumar, S Vincent

    2009-08-10

    Inconsistencies and errors resulting from nonstandard processes, together with redundancies, rework, and excess workload, lead to extended time frames for clinical trial protocol development. This results in dissatisfaction among sponsors, investigators, and staff and restricts the availability of novel treatment options for patients. A team of experts from Mayo Clinic formed, including Protocol Development Unit staff and management from the three Mayo Clinic campuses (Florida, Minnesota, and Arizona), a systems and procedures analyst, a quality office analyst, and two physician members to address the identified deficiencies. The current-state process was intensively reviewed, and improvement steps were taken to accelerate the development and approval of cancer-related clinical trials. The primary goal was to decrease the time from receipt of a new protocol through submission to an approving authority, such as the National Cancer Institute or institutional review board. Using the Define, Measure, Analyze, Improve, Control (DMAIC) framework infused with Lean waste-reduction methodologies, areas were identified for improvement, including enhancing first-time quality and processing new studies on a first-in/first-out basis. The project was successful in improving the mean turnaround time for internally authored protocols (P DMAIC framework combined with Lean methodologies is an effective tool to structure the definition, planning, analysis, and implementation of significant process changes.

  8. Boron neutron capture therapy applied to advanced breast cancers: Engineering simulation and feasibility study of the radiation treatment protocol

    Science.gov (United States)

    Sztejnberg Goncalves-Carralves, Manuel Leonardo

    This dissertation describes a novel Boron Neutron Capture Therapy (BNCT) application for the treatment of human epidermal growth factor receptor type 2 positive (HER2+) breast cancers. The original contribution of the dissertation is the development of the engineering simulation and the feasibility study of the radiation treatment protocol for this novel combination of BNCT and HER2+ breast cancer treatment. This new concept of BNCT, representing a radiation binary targeted treatment, consists of the combination of two approaches never used in a synergism before. This combination may offer realistic hope for relapsed and/or metastasized breast cancers. This treatment assumes that the boronated anti-HER2 monoclonal antibodies (MABs) are administrated to the patient and accumulate preferentially in the tumor. Then the tumor is destroyed when is exposed to neutron irradiation. Since the use of anti-HER2 MABs yields good and promising results, the proposed concept is expected to amplify the known effect and be considered as a possible additional treatment approach to the most severe breast cancers for patients with metastasized cancer for which the current protocol is not successful and for patients refusing to have the standard treatment protocol. This dissertation makes an original contribution with an integral numerical approach and proves feasible the combination of the aforementioned therapy and disease. With these goals, the dissertation describes the theoretical analysis of the proposed concept providing an integral engineering simulation study of the treatment protocol. An extensive analysis of the potential limitations, capabilities and optimization factors are well studied using simplified models, models based on real CT patients' images, cellular models, and Monte Carlo (MCNP5/X) transport codes. One of the outcomes of the integral dosimetry assessment originally developed for the proposed treatment of advanced breast cancers is the implementation of BNCT

  9. 75 FR 63488 - Submission for OMB Review; Comment Request; Multi-Ethnic Study of Atherosclerosis (MESA) Event...

    Science.gov (United States)

    2010-10-15

    ... Study of Atherosclerosis (MESA) Event Surveillance SUMMARY: Under the provisions of Section 3507(a)(1)(D... Collection: Title: Multi-Ethnic Study of Atherosclerosis (MESA) Event Surveillance. Type of Information..., including the use of appropriate automated, electronic, mechanical, or other technological collection...

  10. Centralization of politrauma. Study of Ferrara’s reality and simulation of an agreed-upon protocol

    Directory of Open Access Journals (Sweden)

    Luigi Melcarne

    2011-09-01

    Full Text Available In a time in which everybody’s asked a big effort to use hospitals, resources and emergency departments in a rational way, the Centralization – that is sending the right patient to the right hospital at the right time – allows an optimization of the resources and a better management of medical patients. In this study we examined the actual state of Centralization in the city of Ferrara where an experimental protocol of “centralization” has been introduced. This study has the purpose of simulating reality if the protocol had been introduced in the years 2008/2009. The results confirm not only that an important number of patients that were meant to be sent to the CTZ of Ferrara where instead sent to the PST but also that, on the contrary, patients from the suburbs that didn’t require advanced treatments were sent to the Sant’Anna hospital of Ferrara. So if medical literature already points out the advantages of a correct Centralization for patients with polytraumas; the study, based on the reality in Ferrara , shows how the creation of an agreed protocol with the goal to guide health workers at sending polytrauma patients to the right destination , instead of creating an excessive flow th the main hub, can improve the overall organization of health services, with an equal distribution between hub and spoke. When considering First Aid not always speed and rapidity guarantee survival; this is so much more real in the case of patients with polytrauma, where quality of cures assumes more importance than time.

  11. An evaluation of two large scale demand side financing programs for maternal health in India: the MATIND study protocol.

    Science.gov (United States)

    Sidney, Kristi; de Costa, Ayesha; Diwan, Vishal; Mavalankar, Dileep V; Smith, Helen

    2012-08-27

    High maternal mortality in India is a serious public health challenge. Demand side financing interventions have emerged as a strategy to promote access to emergency obstetric care. Two such state run programs, Janani Suraksha Yojana (JSY)and Chiranjeevi Yojana (CY), were designed and implemented to reduce financial access barriers that preclude women from obtaining emergency obstetric care. JSY, a conditional cash transfer, awards money directly to a woman who delivers in a public health facility. This will be studied in Madhya Pradesh province. CY, a voucher based program, empanels private obstetricians in Gujarat province, who are reimbursed by the government to perform deliveries of socioeconomically disadvantaged women. The programs have been in operation for the last seven years. The study outlined in this protocol will assess and compare the influence of the two programs on various aspects of maternal health care including trends in program uptake, institutional delivery rates, maternal and neonatal outcomes, quality of care, experiences of service providers and users, and cost effectiveness. The study will collect primary data using a combination of qualitative and quantitative methods, including facility level questionnaires, observations, a population based survey, in-depth interviews, and focus group discussions. Primary data will be collected in three districts of each province. The research will take place at three levels: the state health departments, obstetric facilities in the districts and among recently delivered mothers in the community. The protocol is a comprehensive assessment of the performance and impact of the programs and an economic analysis. It will fill existing evidence gaps in the scientific literature including access and quality to services, utilization, coverage and impact. The implementation of the protocol will also generate evidence to facilitate decision making among policy makers and program managers who currently work with or

  12. An evaluation of two large scale demand side financing programs for maternal health in India: the MATIND study protocol

    Directory of Open Access Journals (Sweden)

    Sidney Kristi

    2012-08-01

    Full Text Available Abstract Background High maternal mortality in India is a serious public health challenge. Demand side financing interventions have emerged as a strategy to promote access to emergency obstetric care. Two such state run programs, Janani Suraksha Yojana (JSYand Chiranjeevi Yojana (CY, were designed and implemented to reduce financial access barriers that preclude women from obtaining emergency obstetric care. JSY, a conditional cash transfer, awards money directly to a woman who delivers in a public health facility. This will be studied in Madhya Pradesh province. CY, a voucher based program, empanels private obstetricians in Gujarat province, who are reimbursed by the government to perform deliveries of socioeconomically disadvantaged women. The programs have been in operation for the last seven years. Methods/designs The study outlined in this protocol will assess and compare the influence of the two programs on various aspects of maternal health care including trends in program uptake, institutional delivery rates, maternal and neonatal outcomes, quality of care, experiences of service providers and users, and cost effectiveness. The study will collect primary data using a combination of qualitative and quantitative methods, including facility level questionnaires, observations, a population based survey, in-depth interviews, and focus group discussions. Primary data will be collected in three districts of each province. The research will take place at three levels: the state health departments, obstetric facilities in the districts and among recently delivered mothers in the community. Discussion The protocol is a comprehensive assessment of the performance and impact of the programs and an economic analysis. It will fill existing evidence gaps in the scientific literature including access and quality to services, utilization, coverage and impact. The implementation of the protocol will also generate evidence to facilitate decision making

  13. Clinical effectiveness of a sedation protocol minimizing benzodiazepine infusions and favoring early dexmedetomidine: a before-after study.

    Science.gov (United States)

    Skrupky, Lee P; Drewry, Anne M; Wessman, Brian; Field, R Ryan; Fagley, Richard E; Varghese, Linda; Lieu, Angela; Olatunde, Joshua; Micek, Scott T; Kollef, Marin H; Boyle, Walter A

    2015-04-02

    Randomized controlled trials suggest clinical outcomes may be improved with dexmedetomidine as compared with benzodiazepines; however, further study and validation are needed. The objective of this study was to determine the clinical effectiveness of a sedation protocol minimizing benzodiazepine use in favor of early dexmedetomidine. We conducted a before-after study including adult surgical and medical intensive care unit (ICU) patients requiring mechanical ventilation and continuous sedation for at least 24 hours. The before phase included consecutive patients admitted between 1 April 2011 and 31 August 31 2011. Subsequently, the protocol was modified to minimize use of benzodiazepines in favor of early dexmedetomidine through a multidisciplinary approach, and staff education was provided. The after phase included consecutive eligible patients between 1 May 2012 and 31 October 2012. A total of 199 patients were included, with 97 patients in the before phase and 102 in the after phase. Baseline characteristics were well balanced between groups. Use of midazolam as initial sedation (58% versus 27%, P mechanical ventilation was significantly reduced in the after phase (110 (IQR, 59 to 192) hours versus 74.5 (IQR, 42 to 148) hours, P =0.029), and significantly fewer patients required tracheostomy (20% versus 9%, P =0.040). The median ICU length of stay was 8 (IQR, 4 to 12) days in the before phase and 6 (IQR, 3 to 11) days in the after phase (P =0.252). Implementing a sedation protocol that targeted light sedation and reduced benzodiazepine use led to significant improvements in the duration of mechanical ventilation and the requirement for tracheostomy, despite increases in the prevalence and duration of ICU delirium.

  14. E-care 4 caregivers - an online intervention for nonprofessional caregivers of patients with depression: study protocol for a pilot randomized controlled trial

    National Research Council Canada - National Science Library

    Bijker, L; Kleiboer, A; Riper, H; Cuijpers, P; Donker, T

    2016-01-01

    .... This paper describes the protocol of a pilot study to evaluate (1) the feasibility of an online self-management intervention, E-care 4 caregivers, for the nonprofessional caregiver of patients with depression, and (2...

  15. Botulinum neurotoxin type A in the treatment of classical Trigeminal Neuralgia (BoTN): study protocol for a randomized controlled trial

    National Research Council Canada - National Science Library

    Burmeister, Jan; Holle, Dagny; Bock, Eva; Ose, Claudia; Diener, Hans-Christoph; Obermann, Mark

    2015-01-01

    .... This is the study protocol of a prospective, placebo-controlled, double blind clinical trial investigating the add-on therapy of subcutaneous administration of botulinum toxin type A injections...

  16. Exploring the role of the nurse manager in supporting point-of-care nurses' adoption of electronic health records: protocol for a qualitative research study.

    Science.gov (United States)

    Strudwick, Gillian; Booth, Richard G; Bjarnadottir, Ragnhildur I; Collins, Sarah; Srivastava, Rani

    2017-10-12

    An increasing number of electronic health record (EHR) systems have been implemented in clinical practice environments where nurses work. Findings from previous studies have found that a number of intended benefits of the technology have not yet been realised to date, partially due to poor system adoption among health professionals such as nurses. Previous studies have suggested that nurse managers can support the effective adoption and use of the technology by nurses. However, no known studies have identified what role nurse managers have in supporting technology adoption, nor the specific strategies that managers can employ to support their staff. Therefore, the purpose of this research is to better understand the role of the nurse manager in point-of-care nurses' use of EHRs, and to identify strategies that may be effective in supporting clinical adoption. This study will use a qualitative descriptive design. Interviews with both nurse managers and point-of-care nursing staff will be conducted in a Canadian mental health and addiction healthcare organisation where an EHR has been implemented. A semistructured interview guide will be used, and interviews will be audio recorded. Transcripts will be analysed using a directed content analysis technique. Strategies to ensure the trustworthiness of the data analysis procedure and findings will be employed. Ethical approval for this study has been obtained. Dissemination strategies may include a paper submission to a peer-reviewed journal, a conference submission and meetings to share findings with the study site leadership team. Findings from this research will be used to inform a future study which aims to assess levels of competencies and perform a psychometric analysis of the Nursing Informatics Competency Assessment for the Nurse Leader instrument in a Canadian context. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is

  17. [Effect of compliance with an antibiotic prophylaxis protocol in surgical site infections in appendectomies. Prospective cohort study].

    Science.gov (United States)

    Sánchez-Santana, Tomás; Del-Moral-Luque, Juan Antonio; Gil-Yonte, Pablo; Bañuelos-Andrío, Luis; Durán-Poveda, Manuel; Rodríguez-Caravaca, Gil

    Antibiotic prophylaxis is the most suitable tool for preventing surgical site infection. This study assessed compliance with antibiotic prophylaxis in surgery for acute appendicitis, and the effect of this compliance on surgical site infection. Prospective cohort study to evaluate compliance with antibiotic prophylaxis protocol in appendectomies. An assessment was made of the level of compliance with prophylaxis, as well as the causes of non-compliance. The incidence of surgical site infection was studied after a maximum incubation period of 30 days. The relative risk adjusted with a logistic regression model was used to assess the effect of non-compliance of prophylaxis on surgical site infection. The study included a total of 930 patients. Antibiotic prophylaxis was indicated in all patients, and administered in 71.3% of cases, with an overall protocol compliance of 86.1%. The principal cause of non-compliance was time of initiation. Cumulative incidence of surgical site infection was 4.6%. No relationship was found between inadequate prophylaxis compliance and infection (relative risk=0.5; 95% CI: 0.1-1.9) (P>.05). Compliance of antibiotic prophylaxis was high, but could be improved. No relationship was found between prophylaxis compliance and surgical site infection rate. Copyright © 2016 Academia Mexicana de Cirugía A.C. Publicado por Masson Doyma México S.A. All rights reserved.

  18. Proper protocol

    NARCIS (Netherlands)

    F. Arbab (Farhad)

    2016-01-01

    textabstractTreating interaction as an explicit first-class concept, complete with its own composition operators, leads to a model of concurrency that allows direct specification and manipulation of protocols as proper mathematical objects. Reo [2,5,6,8] serves as a premier example of such an

  19. Built to last? The sustainability of health system improvements, interventions and change strategies: a study protocol for a systematic review.

    Science.gov (United States)

    Braithwaite, Jeffrey; Testa, Luke; Lamprell, Gina; Herkes, Jessica; Ludlow, Kristiana; McPherson, Elise; Campbell, Margie; Holt, Joanna

    2017-11-12

    The sustainability of healthcare interventions and change programmes is of increasing importance to researchers and healthcare stakeholders interested in creating sustainable health systems to cope with mounting stressors. The aim of this protocol is to extend earlier work and describe a systematic review to identify, synthesise and draw meaning from studies published within the last 5 years that measure the sustainability of interventions, improvement efforts and change strategies in the health system. The protocol outlines a method by which to execute a rigorous systematic review. The design includes applying primary and secondary data collection techniques, consisting of a comprehensive database search complemented by contact with experts, and searching secondary databases and reference lists, using snowballing techniques. The review and analysis process will occur via an abstract review followed by a full-text screening process. The inclusion criteria include English-language, peer-reviewed, primary, empirical research articles published after 2011 in scholarly journals, for which the full text is available. No restrictions on location will be applied. The review that results from this protocol will synthesise and compare characteristics of the included studies. Ultimately, it is intended that this will help make it easier to identify and design sustainable interventions, improvement efforts and change strategies. As no primary data were collected, ethical approval was not required. Results will be disseminated in conference presentations, peer-reviewed publications and among policymaker bodies interested in creating sustainable health systems. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  20. Efficacy of strength and aerobic exercise on patient-reported outcomes and structural changes in patients with knee osteoarthritis: study protocol for a randomized controlled trial

    OpenAIRE

    Øiestad, Britt Elin; Østerås, Nina; Frobell, Richard; Grotle, Margreth; Brøgger, Helga; Risberg, May Arna

    2013-01-01

    Open Access Highly Accessed Study protocol Efficacy of strength and aerobic exercise on patient-reported outcomes and structural changes in patients with knee osteoarthritis: study protocol for a randomized controlled trial Britt Elin Øiestad1*, Nina Østerås2, Richard Frobell3, Margreth Grotle4, Helga Brøgger5 and May Arna Risberg16 * Corresponding author: Britt E Øiestad Author Affiliations 1 Norwegian Research Center for Active Rehabilitation ...

  1. Study protocol: a mixed methods feasibility study for a loaded self-managed exercise programme for patellofemoral pain.

    Science.gov (United States)

    Smith, Benjamin E; Hendrick, Paul; Bateman, Marcus; Moffatt, Fiona; Rathleff, Michael Skovdal; Selfe, James; Smith, Toby O; Logan, Pip

    2018-01-01

    -management. Baseline assessment will include demographic data, average pain within the last week (VAS), fear avoidance behaviours, catastrophising, self-efficacy, sport and leisure activity participation, and general quality of life. Follow-up will be 3 and 6 months. The analysis will focus on descriptive statistics and confidence intervals. The qualitative components will follow a thematic analysis approach. This study will evaluate the feasibility of running a definitive large-scale trial on patients with patellofemoral pain, within the NHS in the UK. We will identify strengths and weaknesses of the proposed protocol and the utility and characteristics of the outcome measures. The results from this study will inform the design of a multicentre trial. ISRCTN35272486.

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

    Science.gov (United States)

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

    2014-02-19

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

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

    Science.gov (United States)

    2014-01-01

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

  4. A protocol for the development of Mediterranean climate services based on the experiences of the CLIM-RUN case studies

    Science.gov (United States)

    Goodess, Clare; Ruti, Paolo; Rousset, Nathalie

    2014-05-01

    During the closing stages of the CLIM-RUN EU FP7 project on Climate Local Information in the Mediterranean region Responding to User Needs, the real-world experiences encountered by the case-study teams are being assessed and synthesised to identify examples of good practice and, in particular, to produce the CLIM-RUN protocol for the development of Mediterranean climate services. The specific case studies have focused on renewable energy (Morocco, Spain, Croatia, Cyprus), tourism (Savoie, Tunisia, Croatia, Cyprus) and wild fires (Greece) as well as one cross-cutting case study (Veneto region). They have been implemented following a common programme of local workshops, questionnaires and interviews, with Climate Expert Team and Stakeholder Expert Team members collaborating to identify and translate user needs and subsequently develop climate products and information. Feedback from stakeholders has been essential in assessing and refining these products. The protocol covers the following issues: the overall process and methodological key stages; identification and selection of stakeholders; communication with stakeholders; identification of user needs; translation of needs; producing products; assessing and refining products; methodologies for evaluating the economic value of climate services; and beyond CLIM-RUN - the lessons learnt. Particular emphasis is given to stakeholder analysis in the context of the participatory, bottom-up approach promoted by CLIM-RUN and to the iterative approach taken in the development of climate products. Recommendations are also made for an envisioned three-tier business model for the development of climate services involving climate, intermediary and stakeholder tiers.

  5. Journal of Business Research: Submissions

    African Journals Online (AJOL)

    Author Guidelines. GUIDELINES FOR AUTHORS: Submission of Papers The JBR welcomes papers from the general academia and professionals. Authors are encouraged to submit papers for publications in the JBR at any time. The Journal will also at specific times solicit for reviews on topical issues of interest. Procedure ...

  6. South African Medical Journal: Submissions

    African Journals Online (AJOL)

    Authorship should be based on: (i) substantial contribution to conceptualisation, design, analysis and interpretation of data; (ii) drafting or critical revision of important scientific ... If authors' names are added or deleted after submission of an article, or the order of the names is changed, all authors must agree to this in writing.

  7. Ghana Journal of Linguistics: Submissions

    African Journals Online (AJOL)

    Author Guidelines. PLEASE follow these guidelines closely when preparing your paper for submission. The editors reserve the right to reject inadequately prepared papers. All areas of linguistics are invited – the journal is not limited to articles on languages of or in Ghana or Africa. ALL CONTRIBUTIONS must be submitted ...

  8. Ghana Journal of Geography: Submissions

    African Journals Online (AJOL)

    Author Guidelines. Submission to the Ghana Journal of Geography. Papers submitted to the journal should follow the guidelines set out below. All correspondence between editor and author is performed by e-mail, and paper copies are not required at all stages. A manuscript must be submitted electronically as an email ...

  9. Nigerian Journal of Paediatrics: Submissions

    African Journals Online (AJOL)

    If digital images are the only source of images, ensure that the image has minimum resolution of 300 dpi or 1800 x 1600 pixels in TIFF format. ... Nigerian Journal of Paediatrics charges Nigerian Naira 5000 (USD25) on submission of manuscript as processing fees and Nigerian Naira 25,000 (USD125) publication fees on ...

  10. Journal for Juridical Science: Submissions

    African Journals Online (AJOL)

    Author Guidelines. 1. Manuscripts may be submitted to Journal for Juridical Science in Afrikaans or English. The desired length of articles is 7 000 words, while 4 500 words is regarded as the minimum and 11 000 as the maximum. 2. Two typed copies of manuscripts must be submitted. In addition submission on computer ...

  11. Orient Journal of Medicine: Submissions

    African Journals Online (AJOL)

    Charges: Authors are required, at the submission of each article, to pay a sum of N15,000 (Fifteen Thousand Naira only) as processing fee at the Journal Office and obtain a written receipt, or pay into the Orient Journal of Medicine Bank Account (Account No. should be obtained directly from the Editor)and mail a scanned ...

  12. Research in Hospitality Management: Submissions

    African Journals Online (AJOL)

    Author Guidelines. Original research papers, substantive topic reviews, viewpoints and short communications that make an original contribution to the understanding of hospitality and hospitality management in a global context will be considered for publication in the Journal. Submissions should be e-mailed to the ...

  13. ChemSearch Journal: Submissions

    African Journals Online (AJOL)

    It publishes original quality articles which are reporting advances in theory, techniques methodology applications and practice, general survey and critical reviews, etc. SUBMISSION OF ARTICLE ... c/o Department of Pure and Industrial Chemistry, Bayero University, P.M.B. 3011, Kano, Nigeria. or. via our Email address: ...

  14. Building America Case Study: Philadelphia Housing Authority Energy-Efficiency Turnover Protocols, Philadelphia, Pennsylvania

    Energy Technology Data Exchange (ETDEWEB)

    2016-02-01

    Over one million HUD-supported public housing units provide rental housing for eligible low-income families across the country. A survey of over 100 public housing authorities (PHAs) across the country indicated that there is a high level of interest in developing low-cost solutions that improve energy efficiency and can be seamlessly included in the refurbishment process. Further, PHAs, have incentives (both internal and external) to reduce utility bills. ARIES worked with four PHAs to develop packages of energy efficiency retrofit measures the PHAs can cost-effectively implement with their own staffs in the normal course of housing operations at the time when units are refurbished between occupancies. The energy efficiency turnover protocols emphasized air infiltration reduction, duct sealing, and measures that improve equipment efficiency. ARIES documented implementation in 18 housing units. Reductions in average air leakage were 16 percent and duct leakage reductions averaged 23 percent. Total source energy consumption savings due to implemented measures was estimated at 3-10 percent based on BEopt modeling with a simple payback of 1.6 to 2.5 years. Implementation challenges were encountered mainly related to required operational changes and budgetary constraints. Nevertheless, simple measures can feasibly be accomplished by PHA staff at low or no cost. At typical housing unit turnover rates, these measures could impact hundreds of thousands of units per year nationally.

  15. Using Think-Aloud Protocols to Uncover Misconceptions and Improve Developmental Math Instruction: An Exploratory Study

    Directory of Open Access Journals (Sweden)

    Charles Secolsky

    2016-01-01

    Full Text Available Deficiencies in education continue to escalate around the world. The focus on outcomes assessment has narrowed instructional research and curriculum evaluation to standardized testing in certain subject areas. A prototype for a quantitative literacy assessment instrument was developed with the goal of diagnosing student misconceptions of basic mathematics content and changing instructional practices to undo the misconceptions by applying cognitive psychological theory. Two hundred thirty-eight basic math high school students and 209 remedial community college students in New Jersey and New York were administered the instrument, which had been based on coded data from think-aloud protocols. The instrument asked students to answer 20 basic mathematics items and, in addition, to evaluate four possible solution strategies. For each item, frequencies of selected solution strategies and the association between strategy selection and performance on the 20-question math test are presented as a means for improving instruction. Follow-up research is proposed for determining whether undoing the student misconceptions first before teaching material on a new unit of instruction may yield more positive student outcomes.

  16. A comparative study of two cooling protocols on stallion sperm cryosurvival.

    Science.gov (United States)

    Contreras-Mendez, L A; Medrano, A

    2016-06-01

    There are many protocols for horse sperm cryopreservation, but results are inconsistent; sperm survival after freeze-thawing is usually poor; in consequence, fertility is low. The objective of this work was to see whether slow cooling before freezing to minus 3 °C instead of +5 °C, the traditional target temperature, could improve horse sperm cryosurvival, capability to carry out capacitation and the acrosome reaction induced by progesterone. Spermatozoa from five stallions were packaged in straws and slowly cooled to +5 °C. Half of the straws were frozen directly and the other half was further cooled to -3 °C before freezing. Progressive motility, viability, plasma membrane integrity, acrosome integrity and capacitation status were assessed. After thawing, there were no differences between cooling treatments on motility, viability, acrosome integrity and capacitation status; however, there was difference (P horse sperm cryosurvival or capability to undergo the acrosome reaction. © 2015 Blackwell Verlag GmbH.

  17. A non-destructive sampling protocol for field studies of seed dispersal by fishes.

    Science.gov (United States)

    Correa, S B; Anderson, J T

    2016-05-01

    This paper presents a standardized protocol for the non-lethal capture of fishes, sampling of stomach contents and quantification of seed dispersal efficiency by frugivorous fishes. Neotropical pacu Piaractus mesopotamicus individuals were collected with fruit-baited hooks. The diets of 110 fish were sampled using a lavage method, which retrieved >90% of stomach contents of both juveniles and adults and allowed individuals to recover within 5 min of treatment. The proportional volume of six food categories was similar for stomachs and whole digestive tracts retrieved by dissection. Fruit pulp was proportionally lower in the stomach. The abundance and species richness of intact seeds increased with fish size independent of whether only stomachs or whole digestive tracts were analysed. The analysis of stomach contents accounted for 62·5% of the total species richness of seeds dispersed by P. mesopotamicus and 96% of common seeds (seed species retrieved from more than one fish). Germination trials revealed that seed viability was similar for seeds collected from the stomach via lavage and seeds that passed through the entire digestive tract. Therefore, stomach contents provide an unbiased representation of the dietary patterns and seed dispersal of frugivorous fishes. © 2016 The Fisheries Society of the British Isles.

  18. Transdiagnostic and Transcultural: Pilot Study of Unified Protocol for Depressive and Anxiety Disorders in Japan.

    Science.gov (United States)

    Ito, Masaya; Horikoshi, Masaru; Kato, Noriko; Oe, Yuki; Fujisato, Hiroko; Nakajima, Shun; Kanie, Ayako; Miyamae, Mitsuhiro; Takebayashi, Yoshitake; Horita, Ryo; Usuki, Masato; Nakagawa, Atsuo; Ono, Yutaka

    2016-05-01

    Unified protocol (UP) is a transdiagnostic cognitive behavior therapy for emotional disorders. It remains unknown whether UP is applicable for use in non-Western countries and for depressive disorders. We therefore examined its feasibility for a Japanese clinical population using this clinical trial design, which is multicentered, open-labeled, and single-armed (Clinical registry: UMIN000008322). The primary outcome was severity of anxiety symptoms, as assessed using Structured Interview Guide for the Hamilton Anxiety Rating Scale. Secondary outcomes were depressive symptoms, clinical global impression, functioning, quality of life, affectivity, emotion regulation, and adverse events. Of the 28 prospective participants, 17 were eligible and enrolled (depressive disorders=9, anxiety disorders=8). Severity of anxiety symptoms, which decreased significantly after the intervention, remained low for 3months (Hedges' g=1.29, 95% CI=0.56-2.06). Similar tendencies were observed for secondary outcome measures. No severe adverse event occurred. Two participants dropped out of the intervention. High treatment adherence and interrater reliability were confirmed. Results suggest the feasibility of UP in the Japanese context sufficient to warrant a larger clinical trial. Copyright © 2016. Published by Elsevier Ltd.

  19. Randomised controlled pilot study to investigate the effectiveness of thoracic epidural and paravertebral blockade in reducing chronic post-thoracotomy pain: TOPIC feasibility study protocol.

    Science.gov (United States)

    Yeung, Joyce; Melody, Teresa; Kerr, Amy; Naidu, Babu; Middleton, Lee; Tryposkiadis, Kostas; Daniels, Jane; Gao, Fang

    2016-12-01

    Open chest surgery (thoracotomy) is considered the most painful of surgical procedures. Forceful wound retraction, costochondral dislocation, posterior costovertebral ligament disruption, intercostal nerve trauma and wound movement during respiration combine to produce an acute, severe postoperative pain insult and persistent chronic pain many months after surgery is common. Three recent systematic reviews conclude that unilateral continuous paravertebral blockade (PVB) provides analgesia at least equivalent to thoracic epidural blockade (TEB) in the postoperative period, has a lower failure rate, and symptom relief that lasted months. Crucially, PVB may reduce the development of subsequent chronic pain by intercostal nerve protection or decreased nociceptive input. The overall aim is to determine in patients who undergo thoracotomy whether perioperative PVB results in reducing chronic post-thoracotomy pain (CPTP) compared with TEB. This pilot study will evaluate feasibility of a substantive trial. TOPIC is a randomised controlled trial comparing the effectiveness of TEB and PVB in reducing CPTP. This is a pilot study to evaluate feasibility of a substantive trial and study processes in 2 adult thoracic centres, Heart of England NHS Foundation Trust (HEFT) and University Hospital of South Manchester NHS Foundation Trust (UHSM). The primary objective is to establish the number of patients randomised as a proportion of those eligible. Secondary objectives include evaluation of study processes. Analyses of feasibility and patient-reported outcomes will primarily take the form of simple descriptive statistics and where appropriate, point estimates of effects sizes and associated 95% CIs. The study has obtained ethical approval from NHS Research Ethics Committee (REC number 14/EM/1280). Dissemination plan includes: informing patients and health professionals; engaging multidisciplinary professionals to support a proposal of a definitive trial and submission for a full

  20. Effectiveness of a Web-Based Protocol for the Screening and Phenotyping of Individuals with Tourette Syndrome for Genetic Studies

    Science.gov (United States)

    Egan, Crystelle; Marakovitz, Susan; O’Rourke, Julia; Osiecki, Lisa; Illmann, Cornelia; Barton, Lauren; McLaughlin, Elizabeth; Proujansky, Rachel; Royal, Justin; Cowley, Heather; Rangel-Lugo, Martha; Pauls, David; Scharf, Jeremiah M.; Mathews, Carol A.

    2014-01-01

    Genome-wide association studies (GWAS) and other emerging technologies offer great promise for the identification of genetic risk factors for complex psychiatric disorders, yet such studies are constrained by the need for large sample sizes. Web-based collection offers a relatively untapped resource for increasing participant recruitment. Therefore, we developed and implemented a novel web-based screening and phenotyping protocol for genetic studies of Tourette Syndrome (TS), a childhood-onset neuropsychiatric disorder characterized by motor and vocal tics. Participants were recruited over a 13 month period through the membership of the Tourette Syndrome Association (TSA) (n=28,878). Of the TSA members contacted, 4.3% (1,242) initiated the questionnaire, and 79.5% (987) of these were enrollment eligible. 63.9% (631) of enrolled participants completed the study by submitting phenotypic data and blood specimens. Age was the only variable that predicted study completion; children and young adults were significantly less likely to be study completers than adults 26 and older. Compared to a clinic-based study conducted over the same time period, the web-based method yielded a 60% larger sample. Web-based participants were older and more often female; otherwise, the sample characteristics did not differ significantly. TS diagnoses based on the web-screen demonstrated 100% accuracy compared to those derived from in-depth clinical interviews. Our results suggest that a web-based approach is effective for increasing the sample size for genetic studies of a relatively rare disorder and that our web-based screen is valid for diagnosing TS. Findings from this study should aid in the development of web-based protocols for other disorders. PMID:23090870

  1. BibSword Implementation of SWORD client in Invenio for the automated submission of digital objects to arXiv

    CERN Document Server

    Barras, Mathieu; Abou Khaled, Omar; Mugellini, Elena

    2010-01-01

    Since recently, arXiv offers a new submission interface implementing SWORD. SWORD is a brand new protocol that defines a simple way to deposit digital document on web repositories. The most part of digital documents submitted on Invenio are also deposited on arXiv. For this reason, it is a relevant added value for Invenio to offers such an automated “Forward to ArXiv” option to its users. The aim of this project is then to analyse, design and implements a library oriented SWORD client module (BibSword). This module will offer an user interface and will be integrated in the Invenio submission process.

  2. BDSM Role Fluidity: A Mixed-Methods Approach to Investigating Switches Within Dominant/Submissive Binaries.

    Science.gov (United States)

    Martinez, Katherine

    2017-08-30

    This mixed-methods study of BDSM investigates the nuances of BDSM participants' role identities, role frequencies, and role fluidities-shifts in identities and play across time, location, scene, and play partner. Data were gathered from 202 online surveys and 25 semistructured interviews about participants' roles given their gender and sexual identities. These data reveal that men tend to self-identify as Dominant, Master, Top, or Sadist (DMTS) and always perform dominant roles, while women tend to self-identify as Submissive, Slave, Bottom, or Masochist (SSBM) and always perform submissive roles. Although this would seem to support the theory that BDSM reinforces gendered dominant/submissive binaries, further analyses indicate that women and queer/pansexual individuals disrupt this binary through their Switch identities and roles. Switching and queer identities, thus, offer the possibility for transforming dominant/submissive and other binaries.

  3. Evaluating nurses' implementation of an infant-feeding counseling protocol for HIV-infected mothers: The Ban Study in Lilongwe, Malawi.

    Science.gov (United States)

    Ferguson, Yvonne Owens; Eng, Eugenia; Bentley, Margaret; Sandelowski, Margarete; Steckler, Allan; Randall-David, Elizabeth; Piwoz, Ellen G; Zulu, Cynthia; Chasela, Charles; Soko, Alice; Tembo, Martin; Martinson, Francis; Tohill, Beth Carlton; Ahmed, Yusuf; Kazembe, Peter; Jamieson, Denise J; van der Horst, Charles; Adair, Linda; Ahmed, Yusuf; Ait-Khaled, Mounir; Albrecht, Sandra; Bangdiwala, Shrikant; Bayer, Ronald; Bentley, Margaret; Bramson, Brian; Bobrow, Emily; Boyle, Nicola; Butera, Sal; Chasela, Charles; Chavula, Charity; Chimerang'ambe, Joseph; Chigwenembe, Maggie; Chikasema, Maria; Chikhungu, Norah; Chilongozi, David; Chiudzu, Grace; Chome, Lenesi; Cole, Anne; Corbett, Amanda; Corneli, Amy; Duerr, Ann; Eliya, Henry; Ellington, Sascha; Eron, Joseph; Farr, Sherry; Ferguson, Yvonne Owens; Fiscus, Susan; Galvin, Shannon; Guay, Laura; Heilig, Chad; Hoffman, Irving; Hooten, Elizabeth; Hosseinipour, Mina; Hudgens, Michael; Hurst, Stacy; Hyde, Lisa; Jamieson, Denise; Joaki, George; Jones, David; Kacheche, Zebrone; Kamanga, Esmie; Kamanga, Gift; Kampani, Coxcilly; Kamthunzi, Portia; Kamwendo, Deborah; Kanyama, Cecilia; Kashuba, Angela; Kathyola, Damson; Kayira, Dumbani; Kazembe, Peter; Knight, Rodney; Kourtis, Athena; Krysiak, Robert; Kumwenda, Jacob; Loeliger, Edde; Luhanga, Misheck; Madhlopa, Victor; Majawa, Maganizo; Maida, Alice; Marcus, Cheryl; Martinson, Francis; Thoofer, Navdeep; Matika, Chrissie; Mayers, Douglas; Mayuni, Isabel; McDonough, Marita; Meme, Joyce; Merry, Ceppie; Mita, Khama; Mkomawanthu, Chimwemwe; Mndala, Gertrude; Mndala, Ibrahim; Moses, Agnes; Msika, Albans; Msungama, Wezi; Mtimuni, Beatrice; Muita, Jane; Mumba, Noel; Musis, Bonface; Mwansambo, Charles; Mwapasa, Gerald; Nkhoma, Jacqueline; Pendame, Richard; Piwoz, Ellen; Raines, Byron; Ramdas, Zane; Rublein, John; Ryan, Mairin; Sanne, Ian; Sellers, Christopher; Shugars, Diane; Sichali, Dorothy; Snowden, Wendy; Soko, Alice; Spensley, Allison; Steens, Jean-Marc; Tegha, Gerald; Tembo, Martin; Thomas, Roshan; Tien, Hsiao-Chuan; Tohill, Beth; van der Horst, Charles; Waalberg, Esther; Wiener, Jeffrey; Wilfert, Cathy; Wiyo, Patricia; Zgambo, Onnocent; Zimba, Chifundo

    2009-04-01

    A process evaluation of nurses' implementation of an infant-feeding counseling protocol was conducted for the Breastfeeding, Antiretroviral and Nutrition (BAN) Study, a prevention of mother-to-child transmission of HIV clinical trial in Lilongwe, Malawi. Six trained nurses counseled HIV-infected mothers to exclusively breastfeed for 24 weeks postpartum and to stop breastfeeding within an additional four weeks. Implementation data were collected via direct observations of 123 infant feeding counseling sessions (30 antenatal and 93 postnatal) and interviews with each nurse. Analysis included calculating a percent adherence to checklists and conducting a content analysis for the observation and interview data. Nurses were implementing the protocol at an average adherence level of 90% or above. Although not detailed in the protocol, nurses appropriately counseled mothers on their actual or intended formula milk usage after weaning. Results indicate that nurses implemented the protocol as designed. Results will help to interpret the BAN Study's outcomes.

  4. Perceived factors influencing nurses' use of evidence-informed protocols for remote cancer treatment-related symptom management: A mixed methods study.

    Science.gov (United States)

    Stacey, Dawn; Carley, Meg; Ballantyne, Barbara; Skrutkowski, Myriam; Whynot, Angela

    2015-06-01

    To assess factors perceived to influence nurses' use of symptom protocols when providing remote management for oncology patients. A mixed methods descriptive study was guided by the Knowledge-to-Action Framework. In 2013, 8 focus groups and 7 interviews were conducted with 49 nurses or patients/family members in three ambulatory oncology programs within different provincial healthcare systems. Role-play with a protocol was used during nurse focus groups/interviews. Nurses who provided remote symptom support received a survey. Data was triangulated using thematic analysis guided by the Ottawa Model of Research Use. Over 90% of nurses provide telephone support during regular hours only. These symptom protocols were being used by 14% of nurses at one program. Nurses rated the protocols positively for content and format (>85%) but 20% indicated too complex. Protocol facilitators were systematic approach, comprehensive, and evidence-based. Protocol barriers were too long, not for symptom clusters, and inadequate space for documenting. To facilitate use, nurses need to enhance their knowledge (73%) and skills (58%), get access to resources, and obtain performance feedback. Nurse barriers included the learning curve, being unaware of protocols, and feeling tied to a script. Organizational barriers were communication challenges with patients, lack of electronic charting, and no clear direction to use them (54%). Several barriers and facilitators were perceived to influence the use of symptom protocols. Nurses and patients/family members identified similar factors. Interventions are needed to overcome barriers to nurses using the protocols such as education, clear organizational mandate, and integration with documentation. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

  5. Treatment influencing down-staging in EORTC Melanoma Group sentinel node histological protocol compared with complete step-sectioning: A national multicentre study

    DEFF Research Database (Denmark)

    Riber-Hansen, Rikke; Hastrup, Nina; Clemmensen, Ole

    2012-01-01

    Metastasis size in melanoma sentinel lymph nodes (SLNs) is an emerging prognostic factor. Two European melanoma treatment trials include SLN metastasis diameters as inclusion criteria. Whilst diameter estimates are sensitive to the number of sections examined, the level of this bias is largely un...... unknown. We performed a prospective multicentre study to compare the European Organisation for Research and Treatment of Cancer (EORTC) recommended protocol with a protocol of complete step-sectioning....

  6. Use acupuncture to relieve perimenopausal syndrome: study protocol of a randomized controlled trial.

    Science.gov (United States)

    Li, Ying; Zheng, Hui; Zheng, Qianhua; Zhao, Ling; Qin, Erqi; Wang, Yu; Zeng, Qian; Zheng, Huabin; Zhao, Yu; Sun, Wei; Zhang, Xiaoxia; Liu, Zhishun; Liu, Baoyan

    2014-05-30

    Whether acupuncture is effective for relieving perimenopausal syndrome has been controversial recently. In this article, we report the protocol of a randomized controlled trial using acupuncture to treat perimenopausal syndrome, aiming to answer this controversy. A multicenter randomized controlled trial with two parallel arms is underway in China. Two hundred and six women with perimenopausal syndrome will be randomly assigned to a treatment group using acupuncture plus auricular acupressure (AA group) and a control group using Climen (Bayer Healthcare Company Limited, Guangzhou, China), a 28-day sequential hormone replacement therapy, in a 1:1 ratio. Participants in the AA group will receive three acupuncture sessions per week in the first 4 weeks and two sessions per week in the following 8 weeks, for a total of 28 sessions over 12 weeks. Auricular points will be plastered by Semen Vaccariae twice per week for a consecutive 12 weeks, with both ears used alternately. The Climen control group is prescribed a tablet containing estradiol valerate 2 mg/day for the first 11 days, and a tablet containing estradiol valerate 2 mg/day plus cyroterone acetate 1 mg/day for the following 10 days. The total treatment period of the control group is three cycles. The post-treatment follow-up period will last 24 weeks. The primary outcome is the Menopause Rating Scale (MRS) assessed at baseline and 4, 12, 16, 24 and 36 weeks after randomization. The secondary outcomes are Menopause-Specific Quality of Life, average hot flash score during 24 hours, serum estradiol, follicle-stimulating hormone and luteinizing hormone level. The first two secondary outcomes are measured at the same point as the MRS. Other secondary outcomes are measured at baseline and 12, 24 weeks after randomization. The results of this trial, which will be available in 2015, will clarify whether acupuncture is effective to relieve perimenopausal syndrome. ClinicalTrials.gov NCT01933204 (registered 9 August 2013).

  7. Prevention of abdominal wound infection (PROUD trial, DRKS00000390: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Heger Ulrike

    2011-11-01

    Full Text Available Abstract Background Wound infection affects a considerable portion of patients after abdominal operations, increasing health care costs and postoperative morbidity and affecting quality of life. Antibacterial coating has been suggested as an effective measure to decrease postoperative wound infections after laparotomies. The INLINE metaanalysis has recently shown the superiority of a slowly absorbable continuous suture for abdominal closure; with PDS plus® such a suture has now been made available with triclosan antibacterial coating. Methods/Design The PROUD trial is designed as a randomised, controlled, observer, surgeon and patient blinded multicenter superiority trial with two parallel groups and a primary endpoint of wound infection during 30 days after surgery. The intervention group will receive triclosan coated polydioxanone sutures, whereas the control group will receive the standard polydioxanone sutures; abdominal closure will otherwise be standardized in both groups. Statistical analysis is based on intention-to-treat population via binary logistic regression analysis, the total sample size of n = 750 is sufficient to ensure alpha = 5% and power = 80%, an interim analysis will be carried out after data of 375 patients are available. Discussion The PROUD trial will yield robust data to determine the effectiveness of antibacterial coating in one of the standard sutures for abdominal closure and potentially lead to amendment of current guidelines. The exploration of clinically objective parameters as well as quality of life holds immediate relevance for clinical management and the pragmatic trial design ensures high external validity. Trial Registration The trial protocol has been registered with the German Clinical Trials Register (DRKS00000390.

  8. A randomised controlled trial of acceptance and commitment therapy (ACT) for psychosis: study protocol.

    Science.gov (United States)

    Thomas, Neil; Shawyer, Frances; Castle, David J; Copolov, David; Hayes, Steven C; Farhall, John

    2014-07-11

    Cognitive behavior therapy for psychosis has been a prominent intervention in the psychological treatment of psychosis. It is, however, a challenging therapy to deliver and, in the context of increasingly rigorous trials, recent reviews have tempered initial enthusiasm about its effectiveness in improving clinical outcomes. Acceptance and commitment therapy shows promise as a briefer, more easily implemented therapy but has not yet been rigorously evaluated in the context of psychosis. The purpose of this trial is to evaluate whether Acceptance and Commitment Therapy could reduce the distress and disability associated with psychotic symptoms in a sample of community-residing patients with chronic medication-resistant symptoms. This is a single (rater)-blind multi-centre randomised controlled trial comparing Acceptance and Commitment Therapy with an active comparison condition, Befriending. Eligible participants have current residual hallucinations or delusions with associated distress or disability which have been present continuously over the past six months despite therapeutic doses of antipsychotic medication. Following baseline assessment, participants are randomly allocated to treatment condition with blinded, post-treatment assessments conducted at the end of treatment and at 6 months follow-up. The primary outcome is overall mental state as measured using the Positive and Negative Syndrome Scale. Secondary outcomes include preoccupation, conviction, distress and disruption to life associated with symptoms as measured by the Psychotic Symptom Rating Scales, as well as social functioning and service utilisation. The main analyses will be by intention-to-treat using mixed-model repeated measures with non-parametric methods employed if required. The model of change underpinning ACT will be tested using mediation analyses. This protocol describes the first randomised controlled trial of Acceptance and commitment therapy in chronic medication-resistant psychosis

  9. Use acupuncture to treat functional constipation: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Li Ying

    2012-07-01

    Full Text Available Abstract Background Whether acupuncture is effective for patients with functional constipation is still unclear. Therefore, we report the protocol of a randomized controlled trial of using acupuncture to treat functional constipation. Design A randomized, controlled, four-arm design, large-scale trial is currently undergoing in China. Seven hundred participants are randomly assigned to three acupuncture treatment groups and Mosapride Citrate control group in a 1:1:1:1 ratio. Participants in acupuncture groups receive 16 sessions of acupuncture treatment, and are followed up for a period of 9 weeks after randomization. The acupuncture groups are: (1 Back-Shu and Front-Mu acupoints of Large Intestine meridians (Shu-Mu points group; (2 He-Sea and Lower He-Sea acupoints of Large Intestine meridians (He points group; (3 Combining used Back-Shu, Front-Mu, He-Sea, and Lower He-Sea acupoints of Large Intestine meridians (Shu-Mu-He points group. The control group is Mosapride Citrate group. The primary outcome is frequency of defecation per week at the fourth week after randomization. The secondary outcomes include Bristol stool scale, the extent of difficulty during defecating, MOS 36-item Short Form health survey (SF-36, Self-Rating Anxiety Scale (SAS, and Self-rating Depression Scale (SDS. The first two of second outcomes are measured 1 week before randomization and 2, 4, and 8 weeks after randomization. Other second outcomes are measured 1 week before randomization and 2 and 4 weeks after randomization, but SF-36 is measured at randomization and 4 weeks after randomization. Discussion The result of this trial (which will be available in 2012 will confirm whether acupuncture is effective to treat functional constipation and whether traditional acupuncture theories play an important role in it. Trials registration Clinical Trials.gov NCT01411501

  10. Study protocol: a randomized controlled trial investigating the effects of a psychosexual training program for adolescents with autism spectrum disorder.

    Science.gov (United States)

    Visser, Kirsten; Greaves-Lord, Kirstin; Tick, Nouchka T; Verhulst, Frank C; Maras, Athanasios; van der Vegt, Esther J M

    2015-08-28

    Previous research shows that adolescents with autism spectrum disorder (ASD) run several risks in their psychosexual development and that these adolescents can have limited access to reliable information on puberty and sexuality, emphasizing the need for specific guidance of adolescents with ASD in their psychosexual development. Few studies have investigated the effects of psychosexual training programs for adolescents with ASD and to date no randomized controlled trials are available to study the effects of psychosexual interventions for this target group. The randomized controlled trial (RCT) described in this study protocol aims to investigate the effects of the Tackling Teenage Training (TTT) program on the psychosexual development of adolescents with ASD. This parallel clinical trial, conducted in the South-West of the Netherlands, has a simple equal randomization design with an intervention and a waiting-list control condition. Two hundred adolescents and their parents participate in this study. We assess the participants in both conditions using self-report as well as parent-report questionnaires at three time points during 1 year: at baseline (T1), post-treatment (T2), and for follow-up (T3). To our knowledge, the current study is the first that uses a randomized controlled design to study the effects of a psychosexual training program for adolescents with ASD. It has a number of methodological strengths, namely a large sample size, a wide range of functionally relevant outcome measures, the use of multiple informants, and a standardized research and intervention protocol. Also some limitations of the described study are identified, for instance not making a comparison between two treatment conditions, and no use of blinded observational measures to investigate the ecological validity of the research results. Dutch Trial Register NTR2860. Registered on 20 April 2011.

  11. Comparative Evaluation of Stroke Triage Algorithms for Emergency Medical Dispatchers (MeDS: Prospective Cohort Study Protocol

    Directory of Open Access Journals (Sweden)

    Bloom Evan

    2011-01-01

    Full Text Available Abstract Background Stroke is a major cause of death and leading cause of disability in the United States. To maximize a stroke patient's chances of receiving thrombolytic treatment for acute ischemic stroke, it is important to improve prehospital recognition of stroke. However, it is known from published reports that emergency medical dispatchers (EMDs using Card 28 of the Medical Priority Dispatch System protocols recognize stroke poorly. Therefore, to improve EMD's recognition of stroke, the National Association of Emergency Medical Dispatchers recently designed a new diagnostic stroke tool (Cincinnati Stroke Scale -CSS to be used with Card 28. The objective of this study is to determine whether the addition of CSS improves diagnostic accuracy of stroke triage. Methods/Design This prospective experimental study will be conducted during a one-year period in the 911 call center of Santa Clara County, CA. We will include callers aged ≥ 18 years with a chief complaint suggestive of stroke and second party callers (by-stander or family who are in close proximity to the patient and can administer the tool ≥ 18 years of age. Life threatening calls will be excluded from the study. Card 28 questions will be administered to subjects who meet study criteria. After completion of Card 28, CSS tool will be administered to all calls. EMDs will record their initial assessment of a cerebro-vascular accident (stroke after completion of Card 28 and their final assessment after completion of CSS. These assessments will be compared with the hospital discharge diagnosis (ICD-9 codes recorded in the Office of Statewide Health Planning and Development (OSHPD database after linking the EMD database and OSHPD database using probabilistic linkage. The primary analysis will compare the sensitivity of the two stroke protocols using logistic regression and generalizing estimating equations to account for clustering by EMDs. To detect a 15% difference in sensitivity

  12. Social anxiety, submissiveness, and shame in men and women: a moderated mediation analysis.

    Science.gov (United States)

    Zimmerman, Jacob; Morrison, Amanda S; Heimberg, Richard G

    2015-03-01

    Research suggests a positive relationship between social anxiety and shame; however, few studies have examined this relationship or potential mechanisms. Common behaviours of persons with social anxiety disorder (SAD), such as submissive behaviours, may be more consistent with societal expectations of women than men and therefore more likely to be associated with shame in socially anxious men than women. We examined the hypothesis that submissive behaviours would mediate the relationship between social anxiety and shame in men, but not in women, with SAD. Moderated mediation was examined in a cross-sectional dataset. Gender was modeled to moderate the paths from social anxiety to submissive behaviours and from submissive behaviours to shame. We also examined an alternative model of the relationships among these variables and the potential contributory role of depression. Men (n = 48) and women (n = 40) with SAD completed the Social Interaction Anxiety Scale, Submissive Behaviour Scale, Internalized Shame Scale, and Beck Depression Inventory. Analyses supported the hypothesized model. The relationship between submissive behaviours and shame was greater in men than women with SAD; the relationship between social anxiety and submissive behaviours was not. Controlling for depression, moderation remained evident although diminished. Results for the comparison model did not support gender moderation. Submissive behaviours mediated the relationship between social anxiety and shame in men, but not women, with SAD. These findings provide preliminary evidence for a model of shame in SAD and may help to further elucidate specific features of SAD that differ between men and women. Although researchers have argued that the display of submissive behaviours might allow the socially anxious individual to limit or prevent attacks on the self, our results suggest that there are greater costs, with regard to feelings of shame, associated with such behaviours for men. In men with SAD

  13. A comparative study of the use of the Istanbul Protocol amongst civil society organizations in low-income countries.

    Science.gov (United States)

    Kelly, Toby; Jensen, Steffen; Koch Andersen, Morten; Christiansen, Catrine; Sharma, Jeevan Raj

    2016-01-01

    The Istanbul Protocol (IP) is one of the great success stories of the global anti-torture movement, setting out universal guidelines for the production of rigorous, objective and reliable evidence about allegations of torture and ill-treatment. The IP is explicitly designed to outline 'minimum standards for States'. However, it is all too often left to civil society organizations to investigate allegations of torture and ill-treatment. In this context, important questions remain as to how and where the IP can be used best by such organizations. These questions are particularly acute in situations where human rights groups may have limited institutional capacity. This paper explores the practical challenges faced by civil society in using the IP in Low-Income Countries. It is based on qualitative research in three case studies: Nepal, Kenya and Bangladesh. This research involved over 80 interviews with human rights practitioners. The conclusions of the paper are that the Istanbul Protocol provides a useful framework for documentation, but more comprehensive forms of documentation will often be limited to a very small - albeit important - number of legal cases. In many cases, the creation of precise and standardized forms of evidence is not necessarily the most effective form of documentation for redress or accountability. In the absence of legal systems willing and able to respond effectively to allegations of torture and ill-treatment, there are severe limitations on the practical effectiveness of detailed and technical forms of documentation.

  14. The Dutch ‘Focus on Strength’ intervention study protocol: programme design and production, implementation and evaluation plan

    Directory of Open Access Journals (Sweden)

    G. A. Ten Hoor

    2016-06-01

    Full Text Available Abstract Background Overweight youngsters are better in absolute strength exercises than their normal-weight counterparts; a physiological phenomenon with promising psychological impact. In this paper we describe the study protocol of the Dutch, school-based program ‘Focus on Strength’ that aims to improve body composition of 11–13 year old students, and with that to ultimately improve their quality of life. Methods The development of this intervention is based on the Intervention Mapping (IM protocol, which starts from a needs assessment, uses theory and empirical research to develop a detailed intervention plan, and anticipates program implementation and evaluation. This novel intervention targets first year students in preparatory secondary vocational education (11–13 years of age. Teachers are the program implementers. One part of the intervention involves a 30 % increase of strength exercises in the physical education lessons. The other part is based on Motivational Interviewing, promoting autonomous motivation of students to become more physically active outside school. Performance and change objectives are described for both teachers and students. The effectiveness of the intervention will be tested in a Randomized Controlled Trial in 9 Dutch high schools. Discussion Intervention Mapping is a useful framework for program planning a school-based program to improve body composition and motivation to exercise in 11–13 year old adolescents by a “Focus on Strength”. Trial registration NTR5676 , registered 8 February 2016 (retrospectively registered.

  15. Detection of Outliers Due to Participants' Non-Adherence to Protocol in a Longitudinal Study of Cognitive Decline.

    Directory of Open Access Journals (Sweden)

    Aline Dugravot

    Full Text Available Participants' non adherence to protocol affects data quality. In longitudinal studies, this leads to outliers that can be present at the level of the population or the individual. The purpose of the present study is to elaborate a method for detection of outliers in a study of cognitive ageing.In the Whitehall II study, data on a cognitive test battery have been collected in 1997-99, 2002-04, 2007-09 and 2012-13. Outliers at the 2012-13 wave were identified using a 4-step procedure: (1 identify cognitive tests with potential non-adherence to protocol, (2 choose a prediction model between a simple model with socio-demographic covariates and one that also includes health behaviours and health measures, (3 define an outlier using a studentized residual, and (4 study the impact of exclusion of outliers by estimating the effect of age and diabetes on cognitive decline.5516 participants provided cognitive data in 2012-13. Comparisons of rates of annual decline over the first three and all four waves of data suggested outliers in three of the 5 tests. Mean residuals for the 2012-13 wave were larger for the basic compared to the more complex prediction model (all p<0.001, leading us to use the latter for the identification of outliers. Residuals greater than two standard deviation of residuals identified approximately 7% of observations as being outliers. Removal of these observations from the analyses showed that both age and diabetes had associations with cognitive decline similar to that observed with the first three waves of data; these associations were weaker or absent in non-cleaned data.Identification of outliers is important as they obscure the effects of known risk factor and introduce bias in the estimates of cognitive decline. We showed that an informed approach, using the range of data collected in a longitudinal study, may be able to identify outliers.

  16. Development of an Optimized Protocol for NMR Metabolomics Studies of Human Colon Cancer Cell Lines and First Insight from Testing of the Protocol Using DNA G-Quadruplex Ligands as Novel Anti-Cancer Drugs

    Directory of Open Access Journals (Sweden)

    Ilaria Lauri

    2016-01-01

    Full Text Available The study of cell lines by nuclear magnetic resonance (NMR spectroscopy metabolomics represents a powerful tool to understand how the local metabolism and biochemical pathways are influenced by external or internal stimuli. In particular, the use of adherent mammalian cells is emerging in the metabolomics field in order to understand the molecular mechanism of disease progression or, for example, the cellular response to drug treatments. Hereto metabolomics investigations for this kind of cells have generally been limited to mass spectrometry studies. This study proposes an optimized protocol for the analysis of the endo-metabolome of human colon cancer cells (HCT116 by NMR. The protocol includes experimental conditions such as washing, quenching and extraction. In order to test the proposed protocol, it was applied to an exploratory study of cancer cells with and without treatment by anti-cancer drugs, such as DNA G-quadruplex binders and Adriamycin (a traditional anti-cancer drug. The exploratory NMR metabolomics analysis resulted in NMR assignment of all endo-metabolites that could be detected and provided preliminary insights about the biological behavior of the drugs tested.

  17. Development of an Optimized Protocol for NMR Metabolomics Studies of Human Colon Cancer Cell Lines and First Insight from Testing of the Protocol Using DNA G-Quadruplex Ligands as Novel Anti-Cancer Drugs.

    Science.gov (United States)

    Lauri, Ilaria; Savorani, Francesco; Iaccarino, Nunzia; Zizza, Pasquale; Pavone, Luigi Michele; Novellino, Ettore; Engelsen, Søren Balling; Randazzo, Antonio

    2016-01-15

    The study of cell lines by nuclear magnetic resonance (NMR) spectroscopy metabolomics represents a powerful tool to understand how the local metabolism and biochemical pathways are influenced by external or internal stimuli. In particular, the use of adherent mammalian cells is emerging in the metabolomics field in order to understand the molecular mechanism of disease progression or, for example, the cellular response to drug treatments. Hereto metabolomics investigations for this kind of cells have generally been limited to mass spectrometry studies. This study proposes an optimized protocol for the analysis of the endo-metabolome of human colon cancer cells (HCT116) by NMR. The protocol includes experimental conditions such as washing, quenching and extraction. In order to test the proposed protocol, it was applied to an exploratory study of cancer cells with and without treatment by anti-cancer drugs, such as DNA G-quadruplex binders and Adriamycin (a traditional anti-cancer drug). The exploratory NMR metabolomics analysis resulted in NMR assignment of all endo-metabolites that could be detected and provided preliminary insights about the biological behavior of the drugs tested.

  18. A six-step protocol to systematic process evaluation of multicomponent cluster-randomised health promoting interventions illustrated by the Boost study

    DEFF Research Database (Denmark)

    Aarestrup, Anne Kristine; Jørgensen, Thea Suldrup; Due, Pernille

    2014-01-01

    and concepts, we developed a six-step protocol: 1. Brainstorm of processes necessary for full implementation and potential barriers and facilitators to implementation; 2. Application of process evaluation concepts to ensure inclusion of important implementation processes; 3. Measurement of proximal outcomes; 4....... Identification of relevant data sources; 5. Selection of methods and timing of data collection of process measures; 6. Development of instruments. The protocol was applied to the Boost study, a multicomponent school-based dietary intervention. RESULTS AND CONCLUSIONS: The protocol was readily applicable...... for planning process evaluation of environmental and educational intervention components in a school setting. The protocol ensures systematic assessment of the implementation processes that are crucial for interpretation of intervention effects. TRIAL REGISTRATION: Current Controlled Trials ISRCTN11666034....

  19. South African Music Studies: Submissions

    African Journals Online (AJOL)

    Articles should be typed in Microsoft Word using 1.5 spacing for the text and single spacing for indented quotes (5 lines or longer), left-aligned, font 12 point Times New Roman. Short quotes, heightened words, and quotes within quotes should all use single quotation marks. Authors should consult SAMUS 28 and SAMUS ...

  20. Journal for Islamic Studies: Submissions

    African Journals Online (AJOL)

    Michel Foucault, Discipline and Punish, trans. A. Sheridan (New York: Pantheon, 1977). Chapter in an edited book. Shehada, Nahda Younis. “Justice without Drama: Observations from Gaza City Sharia Court,” in Inger Marie Okkenhaug and Ingvild Flaskerud (eds.), Gender, Religion and Change in the Middle East, 13-28 ...

  1. A cluster randomized trial on improving nurses' detection and management of elder abuse and neglect (I-NEED): study protocol.

    Science.gov (United States)

    Loh, Debbie Ann; Choo, Wan Yuen; Hairi, Noran Naqiah; Othman, Sajaratulnisah; Mohd Hairi, Farizah; Mohd Mydin, Fadzilah Hanum; Jaafar, Siti Nur Illiani; Tan, Maw Pin; Mohd Ali, Zainudin; Abdul Aziz, Suriyati; Ramli, Rohaya; Mohamad, Rosmala; Lal Mohammad, Zaiton; Hassan, Norlela; Brownell, Patricia; Bulgiba, Awang

    2015-11-01

    The aim of this study was to describe a trial protocol of an educational intervention for nurses to improve their awareness and practice in detecting and managing elder abuse and neglect. Knowledgeable and skilful nurses are crucial amidst the growing numbers of maltreated older patients. This trial is a multi-site, three-armed, community-based cluster randomized controlled trial with 6-months follow-up. This study will involve 390 community and registered nurses from government health clinics in Negeri Sembilan, Malaysia (protocol approved in October 2013). This three-phased study, premised on the Precede-Proceed Model, comprises baseline focus group discussion and survey (Phase 1), development of training module (Phase 2) and implementation and evaluation of the training (Phase 3). Eligible participants will be randomized to the control group (continuous nursing education), intervention group A (face-to-face intensive training programme) or group B (face-to-face intensive training programme and an educational video). Outcome measures include improvement in knowledge and awareness on elder abuse and neglect and the number of cases identified and managed during follow-up. Data will be collected at baseline, immediate postintervention, 3- and 6-month follow-up. Findings from this study will provide empirical support for the development of a training module for nurses on the detection and management of elder abuse and neglect, towards improving healthcare delivery and the well-being of vulnerable older adults. This study is funded by the University of Malaya Research Grant (RP001C-13HTM), (FL002-13SBS) and University of Malaya Grand Challenge (PEACE) Grant (GC001C-14HTM) awarded in May 2013, July 2013 and September 2014. © 2015 John Wiley & Sons Ltd.

  2. Study protocol. The Childhood Health, Activity, and Motor Performance School Study Denmark (The CHAMPS-study DK)

    Science.gov (United States)

    2012-01-01

    Background An increasingly passive life-style in the Western World has led to a rise in life-style related disorders. This is a major concern for all segments of society. The county council of the municipality of Svendborg in Denmark, created six Sport Schools with increased levels of suitable physical activities, which made it possible to study the health outcomes in these children whilst comparing them to children who attended the ‘normal’ schools of the region using the design of a “natural experiment”. Methods Children from the age of 6 till the age of 10, who accepted to be included in the monitoring process, were surveyed at baseline with questionnaires, physical examinations and physical and biological testing, including DXA scans. The physical examination and testing was repeated during the early stage of the study. Every week over the whole study period, the children will be followed with an automated mobile phone text message (SMS-Track) asking questions on their leisure time sports activities and the presence of any musculoskeletal problems. Children who report any such problems are monitored individually by health care personnel. Data are collected on demography, health habits and attitudes, physical characteristics, physical activity using accelerometers, motor performance, fitness, bone health, life-style disorders, injuries and musculoskeletal problems. Data collection will continue at least once a year until the children reach grade 9. Discussion This project is embedded in a local community, which set up the intervention (The Sport Schools) and thereafter invited researchers to provide documentation and evaluation. Sport schools are well matched with the ‘normal’ schools, making comparisons between these suitable. However, subgroups that would be specifically targeted in lifestyle intervention studies (such as the definitely obese) could be relatively small. Therefore, results specific to minority groups may be diluted. Nonetheless, the

  3. Study protocol. The Childhood Health, Activity, and Motor Performance School Study Denmark (The CHAMPS-study DK

    Directory of Open Access Journals (Sweden)

    Wedderkopp Niels

    2012-08-01

    Full Text Available Abstract Background An increasingly passive life-style in the Western World has led to a rise in life-style related disorders. This is a major concern for all segments of society. The county council of the municipality of Svendborg in Denmark, created six Sport Schools with increased levels of suitable physical activities, which made it possible to study the health outcomes in these children whilst comparing them to children who attended the ‘normal’ schools of the region using the design of a “natural experiment”. Methods Children from the age of 6 till the age of 10, who accepted to be included in the monitoring process, were surveyed at baseline with questionnaires, physical examinations and physical and biological testing, including DXA scans. The physical examination and testing was repeated during the early stage of the study. Every week over the whole study period, the children will be followed with an automated mobile phone text message (SMS-Track asking questions on their leisure time sports activities and the presence of any musculoskeletal problems. Children who report any such problems are monitored individually by health care personnel. Data are collected on demography, health habits and attitudes, physical characteristics, physical activity using accelerometers, motor performance, fitness, bone health, life-style disorders, injuries and musculoskeletal problems. Data collection will continue at least once a year until the children reach grade 9. Discussion This project is embedded in a local community, which set up the intervention (The Sport Schools and thereafter invited researchers to provide documentation and evaluation. Sport schools are well matched with the ‘normal’ schools, making comparisons between these suitable. However, subgroups that would be specifically targeted in lifestyle intervention studies (such as the definitely obese could be relatively small. Therefore, results specific to minority groups may be

  4. Study protocol. The Childhood Health, Activity, and Motor Performance School Study Denmark (The CHAMPS-study DK).

    Science.gov (United States)

    Wedderkopp, Niels; Jespersen, Eva; Franz, Claudia; Klakk, Heidi; Heidemann, Malene; Christiansen, Christina; Møller, Niels Christian; Leboeuf-Yde, Charlotte

    2012-08-20

    An increasingly passive life-style in the Western World has led to a rise in life-style related disorders. This is a major concern for all segments of society. The county council of the municipality of Svendborg in Denmark, created six Sport Schools with increased levels of suitable physical activities, which made it possible to study the health outcomes in these children whilst comparing them to children who attended the 'normal' schools of the region using the design of a "natural experiment". Children from the age of 6 till the age of 10, who accepted to be included in the monitoring process, were surveyed at baseline with questionnaires, physical examinations and physical and biological testing, including DXA scans. The physical examination and testing was repeated during the early stage of the study. Every week over the whole study period, the children will be followed with an automated mobile phone text message (SMS-Track) asking questions on their leisure time sports activities and the presence of any musculoskeletal problems. Children who report any such problems are monitored individually by health care personnel. Data are collected on demography, health habits and attitudes, physical characteristics, physical activity using accelerometers, motor performance, fitness, bone health, life-style disorders, injuries and musculoskeletal problems. Data collection will continue at least once a year until the children reach grade 9. This project is embedded in a local community, which set up the intervention (The Sport Schools) and thereafter invited researchers to provide documentation and evaluation. Sport schools are well matched with the 'normal' schools, making comparisons between these suitable. However, subgroups that would be specifically targeted in lifestyle intervention studies (such as the definitely obese) could be relatively small. Therefore, results specific to minority groups may be diluted. Nonetheless, the many rigorously collected data will make

  5. The Agricultural Model Intercomparison and Improvement Project (AgMIP): Protocols and Pilot Studies

    Science.gov (United States)

    Rosenzweig, C.; Jones, J. W.; Hatfield, J. L.; Ruane, A. C.; Boote, K. J.; Thorburn, P.; Antle, J. M.; Nelson, G. C.; Porter, C.; Janssen, S.; hide

    2012-01-01

    The Agricultural Model Intercomparison and Improvement Project (AgMIP) is a major international effort linking the climate, crop, and economic modeling communities with cutting-edge information technology to produce improved crop and economic models and the next generation of climate impact projections for the agricultural sector. The goals of AgMIP are to improve substantially the characterization of world food security due to climate change and to enhance adaptation capacity in both developing and developed countries. Analyses of the agricultural impacts of climate variability and change require a transdisciplinary effort to consistently link state-of-the-art climate scenarios to crop and economic models. Crop model outputs are aggregated as inputs to regional and global economic models to determine regional vulnerabilities, changes in comparative advantage, price effects, and potential adaptation strategies in the agricultural sector. Climate, Crop Modeling, Economics, and Information Technology Team Protocols are presented to guide coordinated climate, crop modeling, economics, and information technology research activities around the world, along with AgMIP Cross-Cutting Themes that address uncertainty, aggregation and scaling, and the development of Representative Agricultural Pathways (RAPs) to enable testing of climate change adaptations in the context of other regional and global trends. The organization of research activities by geographic region and specific crops is described, along with project milestones. Pilot results demonstrate AgMIP's role in assessing climate impacts with explicit representation of uncertainties in climate scenarios and simulations using crop and economic models. An intercomparison of wheat model simulations near Obregón, Mexico reveals inter-model differences in yield sensitivity to [CO2] with model uncertainty holding approximately steady as concentrations rise, while uncertainty related to choice of crop model increases with

  6. HEART: heart exercise and remote technologies: A randomized controlled trial study protocol

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    Kira Geoffrey

    2011-05-01

    Full Text Available Abstract Background Cardiovascular disease (CVD is the leading cause of death worldwide. Cardiac rehabilitation (CR is aimed at improving health behaviors to slow or reverse the progression of CVD disease. Exercise is a central element of CR. Technologies such as mobile phones and the Internet (mHealth offer potential to overcome many of the psychological, physical, and geographical barriers that have been associated with lack of participation in exercise-based CR. We aim to trial the effectiveness of a mobile phone delivered exercise-based CR program to increase exercise capacity and functional outcomes compared with usual CR care in adults with CVD. This paper outlines the rationale and methods of the trial. Methods A single-blinded parallel two-arm randomized controlled trial is being conducted. A total of 170 people will be randomized at 1:1 ratio either to receive a mHealth CR program or usual care. Participants are identified by CR nurses from two metropolitan hospitals in Auckland, New Zealand through outpatient clinics and existing databases. Consenting participants are contacted to attend a baseline assessment. The intervention consists of a theory-based, personalized, automated package of text and video message components via participants' mobile phones and the Internet to increase exercise behavior, delivered over six months. The control group will continue with usual CR. Data collection occurs at baseline and 24 weeks (post-intervention. The primary outcome is change in maximal oxygen uptake from baseline to 24 weeks. Secondary outcomes include post-intervention measures on self-reported physical activity (IPAQ, cardiovascular risk factors (systolic blood pressure, weight, and waist to hip ratio, health related quality of life (SF-36, and cost-effectiveness. Discussion This manuscript presents the protocol for a randomized controlled trial of a mHealth exercise-based CR program. Results of this trial will provide much needed

  7. Computerised cognitive behaviour therapy for depression in adolescents: study protocol for a feasibility randomised controlled trial.

    Science.gov (United States)

    Wright, Barry; Tindall, Lucy; Littlewood, Elizabeth; Adamson, Joy; Allgar, Victoria; Bennett, Sophie; Gilbody, Simon; Verduyn, Chrissie; Alderson-Day, Ben; Dyson, Lisa; Trépel, Dominic; Ali, Shehzad

    2014-10-31

    The 1 year prevalence of depression in adolescents is about 2%. Treatment with antidepressant medication is not recommended for initial treatment in young people due to concerns over high side effects, poor efficacy and addictive potential. Evidence suggests that cognitive behaviour therapy (CBT) is an effective treatment for depression and is currently one of the main treatment options recommended in adolescents. Given the affinity young people have with information technology they may be treated effectively, more widely and earlier in their illness evolution using computer-administered CBT (CCBT). Currently little is known about the clinical and resource implications of implementing CCBT within the National Health Service for adolescents with low mood/depression. We aim to establish the feasibility of running a fully powered randomised controlled trial (RCT). Adolescents aged 12-18 with low mood/depression, (scoring ≥20 on the Mood and Feelings Questionnaire (MFQ)), will be approached to participate. Consenting participants will be randomised to either a CCBT programme (Stressbusters) or accessing selected websites providing information about low mood/depression. The primary outcome measure will be the Beck Depression Inventory (BDI). Participants will also complete generic health measures (EQ5D-Y, HUI2) and resource use questionnaires to examine the feasibility of cost-effectiveness analysis. Questionnaires will be completed at baseline, 4 and 12-month follow-ups. Progress and risk will be monitored via the MFQ administered at each treatment session. The acceptability of a CCBT programme to adolescents; and the willingness of clinicians to recruit participants and of participants to be randomised, recruitment rates, attrition rates and questionnaire completion rates will be collected for feasibility analysis. We will estimate 'numbers needed' to plan a fully powered RCT of clinical and cost-effectiveness. The current trial protocol received a favourable

  8. Evaluation of methodological protocols using point counts and mist nets: a case study in southeastern Brazil

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    Vagner Cavarzere

    2013-01-01

    Full Text Available Despite their wide use in ornithological surveys, point counts and mist nets follow protocols developed in temperate regions, with little attention to possible modifications for tropical systems. Using these methods on a 3-month basis from December 2009-January 2011 in two forest fragments in southeastern Brazil, we wished to evaluate how long these locations needed to be surveyed with point counts for a relatively complete avifaunal inventory (at least 90% of all species and contacts, and if mist net hourly captures can equally detect numbers of species and individuals. Daily counting with four 20-min points during five consecutive days in a rain forest (MC detected 90% of the estimated species richness after 20 h (60 20-min point counts, while 17 h (51 20-min point counts did not detect 90% of the estimated species richness in a semideciduous forest (IT. The first 5 min of point counting in MC (63% of all species and in IT (65% detected significantly more species than the remaining minutes, but it took 15 min to accumulate 86% of all contacts in both forests. Consecutive 5-day mist netting (~ 9 h/day resulted in 70.5 net-h/m² (MC and 74.8 net-h/m² (IT of sample effort, but 80-85% of the estimated number of species was obtained. Although accumulation curves showed no tendency towards stabilization of the number of observed species, the estimated number of species began to stabilize after the first 20 h in both forests. There was no significant difference in capture rates for both species richness and abundance among hourly net checks, but a trend in which these parameters were highest between the second and fourth checks of the day was observed. A 3-day (43.8 and 63.3 net-h/m² mist netting section was enough to record 90% of the species captured during five days in MC and IT, respectively, while precise enough not to jeopardize species richness estimation. The number of individuals, however, decreased order 34% in MC and 38% in IT under the

  9. Study to the effectiveness of the UNECE Persistent Organic Pollutants (POP). Protocol and cost of additional measures. Phase II: Estimated emission reduction and cost of options for a possible revision of the POP Protocol

    NARCIS (Netherlands)

    Denier van der Gon, H.A.C.; Visschedijk, A.J.H.; Bolscher, M. van het

    2006-01-01

    The rationale is that during the review of the POP Protocol there will be a need for an assessment of the potential for further emission reduction and costs of a possible revision of the Protocol. The sources of POPs listed in the Protocol that are to be addressed revision of the POP Protocol have

  10. Agreements between Industry and Academia on Publication Rights: A Retrospective Study of Protocols and Publications of Randomized Clinical Trials.

    Science.gov (United States)

    Kasenda, Benjamin; von Elm, Erik; You, John J; Blümle, Anette; Tomonaga, Yuki; Saccilotto, Ramon; Amstutz, Alain; Bengough, Theresa; Meerpohl, Joerg J; Stegert, Mihaela; Olu, Kelechi K; Tikkinen, Kari A O; Neumann, Ignacio; Carrasco-Labra, Alonso; Faulhaber, Markus; Mulla, Sohail M; Mertz, Dominik; Akl, Elie A; Bassler, Dirk; Busse, Jason W; Ferreira-González, Ignacio; Lamontagne, Francois; Nordmann, Alain; Gloy, Viktoria; Raatz, Heike; Moja, Lorenzo; Ebrahim, Shanil; Schandelmaier, Stefan; Sun, Xin; Vandvik, Per O; Johnston, Bradley C; Walter, Martin A; Burnand, Bernard; Schwenkglenks, Matthias; Hemkens, Lars G; Bucher, Heiner C; Guyatt, Gordon H; Briel, Matthias

    2016-06-01

    Little is known about publication agreements between industry and academic investigators in trial protocols and the consistency of these agreements with corresponding statements in publications. We aimed to investigate (i) the existence and types of publication agreements in trial protocols, (ii) the completeness and consistency of the reporting of these agreements in subsequent publications, and (iii) the frequency of co-authorship by industry employees. We used a retrospective cohort of randomized clinical trials (RCTs) based on archived protocols approved by six research ethics committees between 13 January 2000 and 25 November 2003. Only RCTs with industry involvement were eligible. We investigated the documentation of publication agreements in RCT protocols and statements in corresponding journal publications. Of 647 eligible RCT protocols, 456 (70.5%) mentioned an agreement regarding publication of results. Of these 456, 393 (86.2%) documented an industry partner's right to disapprove or at least review proposed manuscripts; 39 (8.6%) agreements were without constraints of publication. The remaining 24 (5.3%) protocols referred to separate agreement documents not accessible to us. Of those 432 protocols with an accessible publication agreement, 268 (62.0%) trials were published. Most agreements documented in the protocol were not reported in the subsequent publication (197/268 [73.5%]). Of 71 agreements reported in publications, 52 (73.2%) were concordant with those documented in the protocol. In 14 of 37 (37.8%) publications in which statements suggested unrestricted publication rights, at least one co-author was an industry employee. In 25 protocol-publication pairs, author statements in publications suggested no constraints, but 18 corresponding protocols documented restricting agreements. Publication agreements constraining academic authors' independence are common. Journal articles seldom report on publication agreements, and, if they do, statements can

  11. Agreements between Industry and Academia on Publication Rights: A Retrospective Study of Protocols and Publications of Randomized Clinical Trials.

    Directory of Open Access Journals (Sweden)

    Benjamin Kasenda

    2016-06-01

    Full Text Available Little is known about publication agreements between industry and academic investigators in trial protocols and the consistency of these agreements with corresponding statements in publications. We aimed to investigate (i the existence and types of publication agreements in trial protocols, (ii the completeness and consistency of the reporting of these agreements in subsequent publications, and (iii the frequency of co-authorship by industry employees.We used a retrospective cohort of randomized clinical trials (RCTs based on archived protocols approved by six research ethics committees between 13 January 2000 and 25 November 2003. Only RCTs with industry involvement were eligible. We investigated the documentation of publication agreements in RCT protocols and statements in corresponding journal publications. Of 647 eligible RCT protocols, 456 (70.5% mentioned an agreement regarding publication of results. Of these 456, 393 (86.2% documented an industry partner's right to disapprove or at least review proposed manuscripts; 39 (8.6% agreements were without constraints of publication. The remaining 24 (5.3% protocols referred to separate agreement documents not accessible to us. Of those 432 protocols with an accessible publication agreement, 268 (62.0% trials were published. Most agreements documented in the protocol were not reported in the subsequent publication (197/268 [73.5%]. Of 71 agreements reported in publications, 52 (73.2% were concordant with those documented in the protocol. In 14 of 37 (37.8% publications in which statements suggested unrestricted publication rights, at least one co-author was an industry employee. In 25 protocol-publication pairs, author statements in publications suggested no constraints, but 18 corresponding protocols documented restricting agreements.Publication agreements constraining academic authors' independence are common. Journal articles seldom report on publication agreements, and, if they do

  12. Shared Decision Making via Personal Health Record Technology for Routine Use of Diabetic Youth: A Study Protocol.

    Science.gov (United States)

    Davis, Selena; Roudsari, Abdul; Courtney, Karen L

    2017-01-01

    Engaging patients in the self-management decision-making provides opportunities for positive health outcomes. The process of shared decision making (SDM) is touted as the pinnacle of patient-centred care, yet it has been difficult to implement in practice. Access to tools resulting from the integration of all health data and clinical evidence, and an ease of communications with care providers are needed to engage patients in decision making. Personal health record (PHR) technology is a promising approach for overcoming such barriers. Yet there is a scarcity of studies on system design for SDM via PHR. This paper describes a study protocol to identify functional requirements of PHR for facilitating SDM and factors that would influence the embedding of the proposed system in clinical practice.

  13. Perception of pain self-efficacy and fatigue in Greek patients with multiple sclerosis: a study protocol

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    Paraskevi Theofilou

    2015-04-01

    Full Text Available The examination of the perception of pain and fatigue in patients with various health problems has received increased research attention in recent years. The aim of the present study protocol is to examine levels of pain self-efficacy and fatigue in a sample of Greek patients suffering from multiple sclerosis. The association of years and severity of diagnosis with the perception of pain self-efficacy and fatigue will be also investigated. Forty patients from the 3nd Neurological Department, Aristotle University of Thessaloniki (Greece will participate in this study. The measurement tools include i the Fatigue Assessment Scale, ii the Pain Self Efficacy Questionnaire and iii the Expanded Disability Status Scale. Test-retest reliability of the first two questionnaires will be assessed with the same patients rating their situation in a 10 days interval from the first examination in order to examine consistency over time.

  14. A new perspective on adolescent athletes’ transition into upper secondary school: A longitudinal mixed methods study protocol

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    Tatiana V. Ryba

    2016-12-01

    Full Text Available The challenge of combining elite sport and education into a dual career pathway remains to be a source of concern for many high-performance athletes. Previous research findings suggest that committed participation in both domains is highly demanding and success in one pursuit often comes at the expense of the other. There are emergent studies, however, that argue for the beneficial and complementary nature of dual career pathways. Consequently, we emphasize the importance of understanding the processes underlying differences in the development of athletes’ life trajectories. This article presents a study protocol to explore new methodological and analytical approaches that may extend current understandings of the ways psychological and sociocultural processes are interconnected in the construction of adolescent athletes’ identities, motivation, well-being, and career aspirations in the transitory social world.

  15. A web-based computer-tailored smoking prevention programme for primary school children: intervention design and study protocol.

    Science.gov (United States)

    Cremers, Henricus-Paul; Mercken, Liesbeth; Oenema, Anke; de Vries, Hein

    2012-06-11

    Although the number of smokers has declined in the last decade, smoking is still a major health problem among youngsters and adolescents. For this reason, there is a need for effective smoking prevention programmes targeting primary school children. A web-based computer-tailored feedback programme may be an effective intervention to stimulate youngsters not to start smoking, and increase their knowledge about the adverse effects of smoking and their attitudes and self-efficacy regarding non-smoking. This paper describes the development and evaluation protocol of a web-based out-of-school smoking prevention programme for primary school children (age 10-13 years) entitled 'Fun without Smokes'. It is a transformation of a postal mailed intervention to a web-based intervention. Besides this transformation the effects of prompts will be examined. This web-based intervention will be evaluated in a 2-year cluster randomised controlled trial (c-RCT) with three study arms. An intervention and intervention + prompt condition will be evaluated for effects on smoking behaviour, compared with a no information control condition. Information about pupils' smoking status and other factors related to smoking will be obtained using a web-based questionnaire. After completing the questionnaire pupils in both intervention conditions will receive three computer-tailored feedback letters in their personal e-mail box. Attitudes, social influences and self-efficacy expectations will be the content of these personalised feedback letters. Pupils in the intervention + prompt condition will - in addition to the personalised feedback letters - receive e-mail and SMS messages prompting them to revisit the 'Fun without Smokes' website. The main outcome measures will be ever smoking and the utilisation of the 'Fun without Smokes' website. Measurements will be carried out at baseline, 12 months and 24 months of follow-up. The present study protocol describes the purpose, intervention design and

  16. Social facilitation maintenance treatment for adults with obesity: study protocol for a randomised-controlled feasibility study (SFM study).

    Science.gov (United States)

    Hilbert, Anja

    2016-08-31

    The long-term success of non-surgical weight loss treatment in adults with obesity is limited by substantial relapse, and only a few evidence-based weight loss maintenance treatments exist. This clinical trial investigates the feasibility and efficacy of a social facilitation maintenance programme for weight loss maintenance, tailored to meet the needs of obese adults who have undergone a lifestyle weight loss intervention. In a single-centre, open feasibility trial, 72 adults currently or previously obese or overweight who have undergone a lifestyle weight loss intervention are centrally randomised to 4 months of social facilitation maintenance treatment or treatment as a usual control condition. In 16 outpatient group sessions, the social facilitation maintenance treatment, based on a socioecological model and on evidence supporting social facilitation as a key process in maintaining weight loss, focuses on promoting interpersonal relationships to build up a healthy lifestyle for long-term weight loss maintenance. Primary outcome is the amount of weight regain at 6-month follow-up, compared with pre-treatment weight, derived from measured body weight. Secondary outcomes address feasibility, including recruitment, attrition, assessment non-completion, compliance and patients' programme evaluation; and in comparison with pre-weight loss maintenance, social and interpersonal functioning, eating behaviour and physical activity, psychological and physical symptoms, body composition and risk of comorbidity, and quality of life at post-treatment and follow-up assessments. The study was approved by the Ethical Committee at the University of Leipzig (165-13-15072013). The study results will be disseminated through peer-reviewed publications. DRKS00005182. 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/

  17. MAVIDOS Maternal Vitamin D Osteoporosis Study: study protocol for a randomized controlled trial. The MAVIDOS Study Group.

    Science.gov (United States)

    Harvey, Nicholas C; Javaid, Kassim; Bishop, Nicholas; Kennedy, Stephen; Papageorghiou, Aris T; Fraser, Robert; Gandhi, Saurabh V; Schoenmakers, Inez; Prentice, Ann; Cooper, Cyrus

    2012-02-07

    MAVIDOS is a randomised, double-blind, placebo-controlled trial (ISRCTN82927713, registered 2008 Apr 11), funded by Arthritis Research UK, MRC, Bupa Foundation and NIHR. Osteoporosis is a major public health problem as a result of associated fragility fractures. Skeletal strength increases from birth to a peak in early adulthood. This peak predicts osteoporosis risk in later life. Vitamin D insufficiency in pregnancy is common (31% in a recent Southampton cohort) and predicts reduced bone mass in the offspring. In this study we aim to test whether offspring of mothers supplemented with vitamin D in pregnancy have higher bone mass at birth than those whose mothers were not supplemented. Women have their vitamin D status assessed after ultrasound scanning in the twelfth week of pregnancy at 3 trial centres (Southampton, Sheffield, Oxford). Women with circulating 25(OH)-vitamin D levels 25-100 nmol/l are randomised in a double-blind design to either oral vitamin D supplement (1000 IU cholecalciferol/day, n = 477) or placebo at 14 weeks (n = 477). Questionnaire data include parity, sunlight exposure, dietary information, and cigarette and alcohol consumption. At 19 and 34 weeks maternal anthropometry is assessed and blood samples taken to measure 25(OH)-vitamin D, PTH and biochemistry. At delivery venous umbilical cord blood is collected, together with umbilical cord and placental tissue. The babies undergo DXA assessment of bone mass within the first 14 days after birth, with the primary outcome being whole body bone mineral content adjusted for gestational age and age. Children are then followed up with yearly assessment of health, diet, physical activity and anthropometric measures, with repeat assessment of bone mass by DXA at age 4 years. As far as we are aware, this randomised trial is one of the first ever tests of the early life origins hypothesis in human participants and has the potential to inform public health policy regarding vitamin D supplementation in

  18. MAVIDOS Maternal Vitamin D Osteoporosis Study: study protocol for a randomized controlled trial. The MAVIDOS Study Group

    Directory of Open Access Journals (Sweden)

    Harvey Nicholas C

    2012-02-01

    Full Text Available Abstract MAVIDOS is a randomised, double-blind, placebo-controlled trial (ISRCTN82927713, registered 2008 Apr 11, funded by Arthritis Research UK, MRC, Bupa Foundation and NIHR. Background Osteoporosis is a major public health problem as a result of associated fragility fractures. Skeletal strength increases from birth to a peak in early adulthood. This peak predicts osteoporosis risk in later life. Vitamin D insufficiency in pregnancy is common (31% in a recent Southampton cohort and predicts reduced bone mass in the offspring. In this study we aim to test whether offspring of mothers supplemented with vitamin D in pregnancy have higher bone mass at birth than those whose mothers were not supplemented. Methods/Design Women have their vitamin D status assessed after ultrasound scanning in the twelfth week of pregnancy at 3 trial centres (Southampton, Sheffield, Oxford. Women with circulating 25(OH-vitamin D levels 25-100 nmol/l are randomised in a double-blind design to either oral vitamin D supplement (1000 IU cholecalciferol/day, n = 477 or placebo at 14 weeks (n = 477. Questionnaire data include parity, sunlight exposure, dietary information, and cigarette and alcohol consumption. At 19 and 34 weeks maternal anthropometry is assessed and blood samples taken to measure 25(OH-vitamin D, PTH and biochemistry. At delivery venous umbilical cord blood is collected, together with umbilical cord and placental tissue. The babies undergo DXA assessment of bone mass within the first 14 days after birth, with the primary outcome being whole body bone mineral content adjusted for gestational age and age. Children are then followed up with yearly assessment of health, diet, physical activity and anthropometric measures, with repeat assessment of bone mass by DXA at age 4 years. Discussion As far as we are aware, this randomised trial is one of the first ever tests of the early life origins hypothesis in human participants and has the potential to inform

  19. [Protocol for neurophysiological studies of the pelvic floor to appraise anorectal dysfunction in patients with multiple sclerosis].

    Science.gov (United States)

    Álvarez-Guerrico, Ion; Royo, Inmaculada; Andreu, Montserrat; Roquer-González, Jaume; Munteis, Elvira

    2016-03-01

    Patients with multiple sclerosis (MS) frequently develop anorectal dysfunction. The neuromuscular structures of the pelvic floor and the mechanisms of voluntary control over defecation can be compromised by the patchy lesions of MS or secondary to the patient's disability. The involvement of multiple factors limits understanding of the pathophysiology of anorectal dysfunction in MS. Specific neurophysiological tests assess the functionality of the elements of the central and peripheral nervous system involved in anorectal dysfunction. To propose a diagnostic protocol of standardised neurophysiological studies of the pelvic floor in order to characterise the pathophysiology of anorectal dysfunction in patients with MS. The following studies were conducted on 16 patients with defined MS and who met criteria for constipation or faecal incontinence: external anal sphincter electromyography (EAS-EMG), somatosensory evoked potentials (SSEP) of the internal pudendal nerve, recording of ano-sacral reflexes and pudendal nerve neurography. The clinical and neurophysiological characteristics were heterogeneous. Nine patients presented constipation; two had isolated faecal incontinence; and five, a combination of both. Abolition or delay in the latency of the SSEP was the most frequent finding (n = 12), followed by the detection of paradoxical contraction (n = 11) and deficient recruitment (n = 8) in the EAS-EMG. The correct interpretation of each available neurophysiological test and the correlation of the findings as a whole enable us to understand the pathophysiology of anorectal dysfunction. The implementation of a protocol for neuro-physiological studies of the pelvic floor makes it possible to adjust the diagnosis by identifying the central or peripheral nervous lesion determining anorectal dysfunction in patients with MS.