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Sample records for chip study protocol

  1. Protocol: Chromatin immunoprecipitation (ChIP) methodology to investigate histone modifications in two model diatom species

    PubMed Central

    2012-01-01

    In this report we describe a chromatin immunoprecipitation (ChIP) protocol for two fully sequenced model diatom species Phaeodactylum tricornutum and Thalassiosira pseudonana. This protocol allows the extraction of satisfactory amounts of chromatin and gives reproducible results. We coupled the ChIP assay with real time quantitative PCR. Our results reveal that the two major histone marks H3K4me2 and H3K9me2 exist in P. tricornutum and T. pseudonana. As in other eukaryotes, H3K4me2 marks active genes whereas H3K9me2 marks transcriptionally inactive transposable elements. Unexpectedly however, T. pseudonana housekeeping genes also show a relative enrichment of H3K9me2. We also discuss optimization of the procedure, including growth conditions, cross linking and sonication. Validation of the protocol provides a set of genes and transposable elements that can be used as controls for studies using ChIP in each diatom species. This protocol can be easily adapted to other diatoms and eukaryotic phytoplankton species for genetic and biochemical studies. PMID:23217141

  2. Developing an Optimum Protocol for Thermoluminescence Dosimetry with GR-200 Chips using Taguchi Method.

    PubMed

    Sadeghi, Maryam; Faghihi, Reza; Sina, Sedigheh

    2016-11-24

    Thermoluminescence dosimetry (TLD) is a powerful technique with wide applications in personal, environmental and clinical dosimetry. The optimum annealing, storage and reading protocols are very effective in accuracy of TLD response. The purpose of this study is to obtain an optimum protocol for GR-200; LiF: Mg, Cu, P, by optimizing the effective parameters, to increase the reliability of the TLD response using Taguchi method. Taguchi method has been used in this study for optimization of annealing, storage and reading protocols of the TLDs. A number of 108 GR-200 chips were divided into 27 groups, each containing four chips. The TLDs were exposed to three different doses, and stored, annealed and read out by different procedures as suggested by Taguchi Method. By comparing the signal-to-noise ratios the optimum dosimetry procedure was obtained. According to the results, the optimum values for annealing temperature (°C), Annealing Time (s), Annealing to Exposure time (d), Exposure to Readout time (d), Pre-heat Temperature (°C), Pre-heat Time (s), Heating Rate (°C/s), Maximum Temperature of Readout (°C), readout time (s) and Storage Temperature (°C) are 240, 90, 1, 2, 50, 0, 15, 240, 13 and -20, respectively. Using the optimum protocol, an efficient glow curve with low residual signals can be achieved. Using optimum protocol obtained by Taguchi method, the dosimetry can be effectively performed with great accuracy.

  3. Development of the protocol of the interface of data exchange with the GBTX chip

    NASA Astrophysics Data System (ADS)

    Shumkin, O. V.; Normanov, D. D.; Ivanov, P. Ya

    2017-01-01

    The structure of the interface of data exchange with the GBTX chip for the CBM experiment is considered. The interface generates a data package, consisting of the digital codes of signal amplitude, signal superposition in peak detector, signal arrival time and channel number, wherein the event has occurred, all these codes being generated by the readout blocks of IC. The created data package is coded according to the 8b/10b format for transferring to the GBTX chip. The packages register of controlling data (warnings on error and desynchronization) are generated for a correct exchange (correspondence) under the GBTX protocol. The adjustment of the quantity of channels, generating data packages and being connected to the GBTX chip, is possible. The interface has been designed according to the 180 nm CMOS technology of UMC.

  4. IFSA: a microfluidic chip-platform for frit-based immunoassay protocols

    NASA Astrophysics Data System (ADS)

    Hlawatsch, Nadine; Bangert, Michael; Miethe, Peter; Becker, Holger; Gärtner, Claudia

    2013-03-01

    Point-of-care diagnostics (POC) is one of the key application fields for lab-on-a-chip devices. While in recent years much of the work has concentrated on integrating complex molecular diagnostic assays onto a microfluidic device, there is a need to also put comparatively simple immunoassay-type protocols on a microfluidic platform. In this paper, we present the development of a microfluidic cartridge using an immunofiltration approach. In this method, the sandwich immunoassay takes place in a porous frit on which the antibodies have immobilized. The device is designed to be able to handle three samples in parallel and up to four analytical targets per sample. In order to meet the critical cost targets for the diagnostic market, the microfluidic chip has been designed and manufactured using high-volume manufacturing technologies in mind. Validation experiments show comparable sensitivities in comparison with conventional immunofiltration kits.

  5. Adaptive Code Division Multiple Access Protocol for Wireless Network-on-Chip Architectures

    NASA Astrophysics Data System (ADS)

    Vijayakumaran, Vineeth

    Massive levels of integration following Moore's Law ushered in a paradigm shift in the way on-chip interconnections were designed. With higher and higher number of cores on the same die traditional bus based interconnections are no longer a scalable communication infrastructure. On-chip networks were proposed enabled a scalable plug-and-play mechanism for interconnecting hundreds of cores on the same chip. Wired interconnects between the cores in a traditional Network-on-Chip (NoC) system, becomes a bottleneck with increase in the number of cores thereby increasing the latency and energy to transmit signals over them. Hence, there has been many alternative emerging interconnect technologies proposed, namely, 3D, photonic and multi-band RF interconnects. Although they provide better connectivity, higher speed and higher bandwidth compared to wired interconnects; they also face challenges with heat dissipation and manufacturing difficulties. On-chip wireless interconnects is one other alternative proposed which doesn't need physical interconnection layout as data travels over the wireless medium. They are integrated into a hybrid NOC architecture consisting of both wired and wireless links, which provides higher bandwidth, lower latency, lesser area overhead and reduced energy dissipation in communication. However, as the bandwidth of the wireless channels is limited, an efficient media access control (MAC) scheme is required to enhance the utilization of the available bandwidth. This thesis proposes using a multiple access mechanism such as Code Division Multiple Access (CDMA) to enable multiple transmitter-receiver pairs to send data over the wireless channel simultaneously. It will be shown that such a hybrid wireless NoC with an efficient CDMA based MAC protocol can significantly increase the performance of the system while lowering the energy dissipation in data transfer. In this work it is shown that the wireless NoC with the proposed CDMA based MAC protocol

  6. Experimental Protocol for Detecting Cyanobacteria in Liquid and Solid Samples with an Antibody Microarray Chip.

    PubMed

    Blanco, Yolanda; Moreno-Paz, Mercedes; Parro, Victor

    2017-02-07

    Global warming and eutrophication make some aquatic ecosystems behave as true bioreactors that trigger rapid and massive cyanobacterial growth; this has relevant health and economic consequences. Many cyanobacterial strains are toxin producers, and only a few cells are necessary to induce irreparable damage to the environment. Therefore, water-body authorities and administrations require rapid and efficient early-warning systems providing reliable data to support their preventive or curative decisions. This manuscript reports an experimental protocol for the in-field detection of toxin-producing cyanobacterial strains by using an antibody microarray chip with 17 antibodies (Abs) with taxonomic resolution (CYANOCHIP). Here, a multiplex fluorescent sandwich microarray immunoassay (FSMI) for the simultaneous monitoring of 17 cyanobacterial strains frequently found blooming in freshwater ecosystems, some of them toxin producers, is described. A microarray with multiple identical replicates (up to 24) of the CYANOCHIP was printed onto a single microscope slide to simultaneously test a similar number of samples. Liquid samples can be tested either by direct incubation with the antibodies (Abs) or after cell concentration by filtration through a 1- to 3-μm filter. Solid samples, such as sediments and ground rocks, are first homogenized and dispersed by a hand-held ultrasonicator in an incubation buffer. They are then filtered (5 - 20 μm) to remove the coarse material, and the filtrate is incubated with Abs. Immunoreactions are revealed by a final incubation with a mixture of the 17 fluorescence-labeled Abs and are read by a portable fluorescence detector. The whole process takes around 3 h, most of it corresponding to two 1-h periods of incubation. The output is an image, where bright spots correspond to the positive detection of cyanobacterial markers.

  7. [The research protocol III. Study population].

    PubMed

    Arias-Gómez, Jesús; Villasís-Keever, Miguel Ángel; Miranda-Novales, María Guadalupe

    2016-01-01

    The study population is defined as a set of cases, determined, limited, and accessible, that will constitute the subjects for the selection of the sample, and must fulfill several characteristics and distinct criteria. The objectives of this manuscript are focused on specifying each one of the elements required to make the selection of the participants of a research project, during the elaboration of the protocol, including the concepts of study population, sample, selection criteria and sampling methods. After delineating the study population, the researcher must specify the criteria that each participant has to comply. The criteria that include the specific characteristics are denominated selection or eligibility criteria. These criteria are inclusion, exclusion and elimination, and will delineate the eligible population. The sampling methods are divided in two large groups: 1) probabilistic or random sampling and 2) non-probabilistic sampling. The difference lies in the employment of statistical methods to select the subjects. In every research, it is necessary to establish at the beginning the specific number of participants to be included to achieve the objectives of the study. This number is the sample size, and can be calculated or estimated with mathematical formulas and statistic software.

  8. [The research protocol IV: study variables].

    PubMed

    Villasís-Keever, Miguel Ángel; Miranda-Novales, María Guadalupe

    2016-01-01

    The variables in a research study are all that is measured, the information collected, or the data that is collected in order to answer the research questions, which are specified in the objectives. Their selection is essential to the research protocol. This article aims to point out the elements to be considered in the section of the variables. To avoid ambiguity, it is necessary to select only those that will help achieve the study objectives. It should subsequently be defined how they will be measured to ensure that the findings can be replicated; it is therefore desirable to include conceptual and operational definitions. From the methodological point of view, the classification of variables helps us understand how the relationship between them is conceptualized. Depending on the study design, the independent, dependent, universal, and confounding variables should be noted. Another indispensable element for planning statistical analyses is the scale of variable measurement. Therefore, one must specify whether the variables correspond to one of the following four: qualitative nominal, qualitative ordinal, quantitative range, or quantitative ratio. Finally, we should detail the measurement units of each variable.

  9. Improvement of Electrical Stimulation Protocol for Simultaneous Measurement of Extracellular Potential with On-Chip Multi-Electrode Array System

    NASA Astrophysics Data System (ADS)

    Kaneko, Tomoyuki; Nomura, Fumimasa; Hattori, Akihiro; Yasuda, Kenji

    2012-06-01

    Cardiotoxicity testing with a multi-electrode array (MEA) system requires the stable beating of cardiomyocytes for the measurement of the field potential duration (FPD), because different spontaneous beating rates cause different responses of FPD prolongation induced by drugs, and the beating rate change effected by drugs complicates the FPD prolongation assessment. We have developed an on-chip MEA system with electrical stimulation for the measurement of the FPD during the stable beating of human embryonic stem (ES) cell-derived cardiomyocyte clusters. Using a conventional bipolar stimulation protocol, we observed such large artifacts in electrical stimulation that we could not estimate the FPD quantitatively. Therefore, we improved the stimulation protocol by using sequential rectangular pulses in which the positive and negative stimulation voltages and number of pulses could be changed flexibly. The balanced voltages and number of pulses for sequential rectangular pulses enabled the recording of small negative artifacts only, which hardly affected the FPD measurement of human-ES-cell-derived cardiomyocyte clusters. These conditions of electrical stimulation are expected to find applications for the control of constant beating for cardiotoxicity testing.

  10. Accelerated Storage Stability and Corrosion Characteristics Study Protocol

    EPA Pesticide Factsheets

    EPA has determined that studies using this protocol will, in certain circumstances, provide the Agency with all the information it needs to make a determination on the storage stability of pesticides.

  11. Study protocol: the Whitehall II imaging sub-study

    PubMed Central

    2014-01-01

    Background The Whitehall II (WHII) study of British civil servants provides a unique source of longitudinal data to investigate key factors hypothesized to affect brain health and cognitive ageing. This paper introduces the multi-modal magnetic resonance imaging (MRI) protocol and cognitive assessment designed to investigate brain health in a random sample of 800 members of the WHII study. Methods/design A total of 6035 civil servants participated in the WHII Phase 11 clinical examination in 2012–2013. A random sample of these participants was included in a sub-study comprising an MRI brain scan, a detailed clinical and cognitive assessment, and collection of blood and buccal mucosal samples for the characterisation of immune function and associated measures. Data collection for this sub-study started in 2012 and will be completed by 2016. The participants, for whom social and health records have been collected since 1985, were between 60–85 years of age at the time the MRI study started. Here, we describe the pre-specified clinical and cognitive assessment protocols, the state-of-the-art MRI sequences and latest pipelines for analyses of this sub-study. Discussion The integration of cutting-edge MRI techniques, clinical and cognitive tests in combination with retrospective data on social, behavioural and biological variables during the preceding 25 years from a well-established longitudinal epidemiological study (WHII cohort) will provide a unique opportunity to examine brain structure and function in relation to age-related diseases and the modifiable and non-modifiable factors affecting resilience against and vulnerability to adverse brain changes. PMID:24885374

  12. Standardisation of Study Protocols - Pros and Cons.

    PubMed

    D'Haens, Geert

    2016-09-01

    Designing clinical trials in inflammatory bowel diseases is challenging. Composite scores that have been used for drug approval until recently such as the Crohn's disease activity index (CDAI) and the Mayo score for ulcerative colitis have been criticized by regulatory bodies for its lack of validation, poor correlation with objective mucosal disease and absence of 'patient reported outcomes'.Most drug development programs use the 'classic 'separation' between an induction and a maintenance phase. Challenging issues are the 'ideal timing' of the primary endpoint for induction and maintenance studies, strategies to reduce placebo response rates and rules for corticosteroids withdrawal. Discussion about which patients to re-randomize after induction into the maintenance phase of the study is critical.Presently, new instruments for disease assessment in IBD are being developed and validated. Central (independent) review of endoscopic recordings at screening and at the end of the intervention will probably become standard. Finally, the most optimal trial design for every individual intervention is likely to depend on the mechanism of action of the medication under study.

  13. High precision thermal stress study on flip chips by synchrotron polychromatic x-ray microdiffraction

    SciTech Connect

    Chen, Kai; Tamura, Nobumichi; Tang, Wei; Kunz, Martin; Chou, Yi-Chia; Tu, King-Ning; Lai, Yi-Shao

    2010-01-01

    The bending and residual stress of flip chips caused by the mismatch of thermal expansion between the chip and the substrate have been measured by polychromatic microfocused synchrotron x-ray beam. Precise orientation information as a function of position on the chip was obtained from Laue diffraction patterns, so that the bending angle with respect to a reference position at the center of the chip can be calculated at each position. This in turn allows deducing the local curvature of the entire flip chip. Local stress distribution was then mapped by applying a modified Stoney's stress-strain equation to the measured curvature. Our study shows that thermal stress on the circuits and the solder joints in a flip chip strongly depend on temperature and the distance from the center of the chip, indicating that interconnects at the corner and edge of a flip chip are of reliability concerns.

  14. Microelectrodes integrated cell-chip for drug effects study

    NASA Astrophysics Data System (ADS)

    Chen, Yu; Cui, Hui-Fang; Ye, Jian-Shan; Chong, Ser-Choong; Lim, Tit-Meng; Sheu, Fwu-Shan; Cheong, Hui-Wing

    2006-01-01

    Silicon-based microelectrode chips are useful tools for temporal recording of neurotransmitter releasing from neural cells. Both invasive and non-invasive methods are targeted by different group researchers to perform electrical stimulating on neural cells. A microfabricated microelectrodes integrated biochip will be presented in this paper, which describes the dopaminergic cells growing on the chip directly. The dopamine exocytosis can be detected non-invasively from drug incubated dopaminergic cells growing on the chip. The abovementioned silicon-based electrochemical sensor chip has been designed with an electrode array located on the bottom of reaction chamber and each electrode is individually electrical controlled. MN9D, a mouse mesencephalic dopaminergic cell line, has been grown on the surface of the biochip chamber directly. Dopamine exocytosis from the chip-grown MN9D cells was detected using amperometry technology. The amperometric detection limit of dopamine of the biochip microelectrodes was found from 0.06μM to 0.21μM (S/N=3) statistically for the electrode diameters from 10 μm to 90 μm, the level of dopamine exocytosis from MN9D cells was undetectable whithout drug incubation. In contrast, after MN9D cells were incubated with L-dopa, a dopamine precursor, K+ induced dopamine extocytosis was temporally detected. The microelectrodes integrated biochip provides a non-invasive, temporal detection of dopamine exocytosis from dopaminergic cells, and holds the potential for applications in studying the mechanisms of dopamine exocytosis, and drug screening. It also provides a tool for pharmaceutical research and drug screening on dopaminergic cells, extendably to be used for other cell culture and drug effects study.

  15. Study on Cloud Security Based on Trust Spanning Tree Protocol

    NASA Astrophysics Data System (ADS)

    Lai, Yingxu; Liu, Zenghui; Pan, Qiuyue; Liu, Jing

    2015-09-01

    Attacks executed on Spanning Tree Protocol (STP) expose the weakness of link layer protocols and put the higher layers in jeopardy. Although the problems have been studied for many years and various solutions have been proposed, many security issues remain. To enhance the security and credibility of layer-2 network, we propose a trust-based spanning tree protocol aiming at achieving a higher credibility of LAN switch with a simple and lightweight authentication mechanism. If correctly implemented in each trusted switch, the authentication of trust-based STP can guarantee the credibility of topology information that is announced to other switch in the LAN. To verify the enforcement of the trusted protocol, we present a new trust evaluation method of the STP using a specification-based state model. We implement a prototype of trust-based STP to investigate its practicality. Experiment shows that the trusted protocol can achieve security goals and effectively avoid STP attacks with a lower computation overhead and good convergence performance.

  16. Lab-on-a-chip technologies for single-molecule studies.

    PubMed

    Zhao, Yanhui; Chen, Danqi; Yue, Hongjun; French, Jarrod B; Rufo, Joseph; Benkovic, Stephen J; Huang, Tony Jun

    2013-06-21

    Recent developments on various lab-on-a-chip techniques allow miniaturized and integrated devices to perform on-chip single-molecule studies. Fluidic-based platforms that utilize unique microscale fluidic behavior are capable of conducting single-molecule experiments with high sensitivities and throughputs, while biomolecular systems can be studied on-chip using techniques such as DNA curtains, magnetic tweezers, and solid-state nanopores. The advances of these on-chip single-molecule techniques lead to next-generation lab-on-a-chip devices, such as DNA transistors, and single-molecule real-time (SMRT) technology for rapid and low-cost whole genome DNA sequencing. In this Focus article, we will discuss some recent successes in the development of lab-on-a-chip techniques for single-molecule studies and expound our thoughts on the near future of on-chip single-molecule studies.

  17. Lab-on-a-chip technologies for single-molecule studies

    PubMed Central

    Zhao, Yanhui; Chen, Danqi; Yue, Hongjun; French, Jarrod B.; Rufo, Joey; Benkovic, Stephen J.; Huang, Tony Jun

    2014-01-01

    Recent developments on various lab-on-a-chip techniques allow miniaturized and integrated devices to perform on-chip single-molecule studies. Fluidic-based platforms that utilize the unique microscale fluidic behavior are capable of conducting single-molecule experiments with high sensitivities and throughputs, while biomolecular systems can be studied on-chip using techniques such as DNA curtains, magnetic tweezers, and solid-state nanopores. The advances of these on-chip single-molecule techniques lead to next-generation lab-on-a-chip devices such as DNA transistors, and single-molecule real-time (SMRT) technology for rapid and low-cost whole genome DNA sequencing. In this Focus article, we will discuss some recent successes on developing lab-on-a-chip techniques for single-molecule studies and expound our thoughts on the near future of on-chip single-molecule studies. PMID:23670195

  18. Computer-Tutors and a Freshman Writer: A Protocol Study.

    ERIC Educational Resources Information Center

    Strickland, James

    Although there are many retrospective accounts from teachers and professional writers concerning the effect of computers on their writing, there are few real-time accounts of students struggling to simultaneously develop as writers and cope with computers. To fill this void in "testimonial data," a study examining talking-aloud protocols from a…

  19. An improved protocol to study the plant cell wall proteome

    PubMed Central

    Printz, Bruno; Dos Santos Morais, Raphaël; Wienkoop, Stefanie; Sergeant, Kjell; Lutts, Stanley; Hausman, Jean-Francois; Renaut, Jenny

    2015-01-01

    Cell wall proteins were extracted from alfalfa stems according to a three-steps extraction procedure using sequentially CaCl2, EGTA, and LiCl-complemented buffers. The efficiency of this protocol for extracting cell wall proteins was compared with the two previously published methods optimized for alfalfa stem cell wall protein analysis. Following LC-MS/MS analysis the three-steps extraction procedure resulted in the identification of the highest number of cell wall proteins (242 NCBInr identifiers) and gave the lowest percentage of non-cell wall proteins (about 30%). However, the three protocols are rather complementary than substitutive since 43% of the identified proteins were specific to one protocol. This three-step protocol was therefore selected for a more detailed proteomic characterization using 2D-gel electrophoresis. With this technique, 75% of the identified proteins were shown to be fraction-specific and 72.7% were predicted as belonging to the cell wall compartment. Although, being less sensitive than LC-MS/MS approaches in detecting and identifying low-abundant proteins, gel-based approaches are valuable tools for the differentiation and relative quantification of protein isoforms and/or modified proteins. In particular isoforms, having variations in their amino-acid sequence and/or carrying different N-linked glycan chains were detected and characterized. This study highlights how the extracting protocols as well as the analytical techniques devoted to the study of the plant cell wall proteome are complementary and how they may be combined to elucidate the dynamism of the plant cell wall proteome in biological studies. Data are available via ProteomeXchange with identifier PXD001927. PMID:25914713

  20. A comparative study of protocols for secure quantum communication under noisy environment: single-qubit-based protocols versus entangled-state-based protocols

    NASA Astrophysics Data System (ADS)

    Sharma, Vishal; Thapliyal, Kishore; Pathak, Anirban; Banerjee, Subhashish

    2016-11-01

    The effect of noise on various protocols of secure quantum communication has been studied. Specifically, we have investigated the effect of amplitude damping, phase damping, squeezed generalized amplitude damping, Pauli type as well as various collective noise models on the protocols of quantum key distribution, quantum key agreement, quantum secure direct quantum communication and quantum dialogue. From each type of protocol of secure quantum communication, we have chosen two protocols for our comparative study: one based on single-qubit states and the other one on entangled states. The comparative study reported here has revealed that single-qubit-based schemes are generally found to perform better in the presence of amplitude damping, phase damping, squeezed generalized amplitude damping noises, while entanglement-based protocols turn out to be preferable in the presence of collective noises. It is also observed that the effect of noise depends upon the number of rounds of quantum communication involved in a scheme of quantum communication. Further, it is observed that squeezing, a completely quantum mechanical resource present in the squeezed generalized amplitude channel, can be used in a beneficial way as it may yield higher fidelity compared to the corresponding zero squeezing case.

  1. Radiation Tolerance Studies of BTeV Pixel Readout Chip Prototypes

    SciTech Connect

    Gabriele Chiodini et al.

    2001-09-11

    We report on several irradiation studies performed on BTeV preFPIX2 pixel readout chip prototypes exposed to a 200 MeV proton beam at the Indiana University Cyclotron Facility. The preFPIX2 pixel readout chip has been implemented in standard 0.25 micron CMOS technology following radiation tolerant design rules. The tests confirmed the radiation tolerance of the chip design to proton total dose of 26 MRad. In addition, non destructive radiation-induced single event upsets have been observed in on-chip static registers and the single bit upset cross section has been measured.

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

    NASA Astrophysics Data System (ADS)

    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

  3. "NeuroStem Chip": a novel highly specialized tool to study neural differentiation pathways in human stem cells

    PubMed Central

    Anisimov, Sergey V; Christophersen, Nicolaj S; Correia, Ana S; Li, Jia-Yi; Brundin, Patrik

    2007-01-01

    Background Human stem cells are viewed as a possible source of neurons for a cell-based therapy of neurodegenerative disorders, such as Parkinson's disease. Several protocols that generate different types of neurons from human stem cells (hSCs) have been developed. Nevertheless, the cellular mechanisms that underlie the development of neurons in vitro as they are subjected to the specific differentiation protocols are often poorly understood. Results We have designed a focused DNA (oligonucleotide-based) large-scale microarray platform (named "NeuroStem Chip") and used it to study gene expression patterns in hSCs as they differentiate into neurons. We have selected genes that are relevant to cells (i) being stem cells, (ii) becoming neurons, and (iii) being neurons. The NeuroStem Chip has over 1,300 pre-selected gene targets and multiple controls spotted in quadruplicates (~46,000 spots total). In this study, we present the NeuroStem Chip in detail and describe the special advantages it offers to the fields of experimental neurology and stem cell biology. To illustrate the utility of NeuroStem Chip platform, we have characterized an undifferentiated population of pluripotent human embryonic stem cells (hESCs, cell line SA02). In addition, we have performed a comparative gene expression analysis of those cells versus a heterogeneous population of hESC-derived cells committed towards neuronal/dopaminergic differentiation pathway by co-culturing with PA6 stromal cells for 16 days and containing a few tyrosine hydroxylase-positive dopaminergic neurons. Conclusion We characterized the gene expression profiles of undifferentiated and dopaminergic lineage-committed hESC-derived cells using a highly focused custom microarray platform (NeuroStem Chip) that can become an important research tool in human stem cell biology. We propose that the areas of application for NeuroStem microarray platform could be the following: (i) characterization of the expression of established

  4. Recommended Protocol for Round Robin Studies in Additive Manufacturing.

    PubMed

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

    2016-03-01

    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.

  5. Recommended Protocol for Round Robin Studies in Additive Manufacturing

    PubMed Central

    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

  6. Analytical and numerical study of Joule heating effects on electrokinetically pumped continuous flow PCR chips.

    PubMed

    Gui, Lin; Ren, Carolyn L

    2008-03-18

    Joule heating is an inevitable phenomenon for microfluidic chips involving electrokinetic pumping, and it becomes a more important issue when chips are made of polymeric materials because of their low thermal conductivities. Therefore, it is very important to develop methods for evaluating Joule heating effects in microfluidic chips in a relatively easy manner. To this end, two analytical models have been established and solved using the Green's function for evaluating Joule heating effects on the temperature distribution in a microfluidic-based PCR chip. The first simplified model focuses on the understanding of Joule heating effects by ignoring the influences of the boundary conditions. The second model aims to consider practical experimental conditions. The analytical solutions to the two models are particularly useful in providing guidance for microfluidic chip design and operation prior to expensive chip fabrication and characterization. To validate the analytical solutions, a 3-D numerical model has also been developed and the simultaneous solution to this model allows the temperature distribution in a microfluidic PCR chip to be obtained, which is used to compare with the analytical results. The developed numerical model has been applied for parametric studies of Joule heating effects on the temperature control of microfluidic chips.

  7. Evaluating outpatient transition clinics: a mixed-methods study protocol

    PubMed Central

    Sattoe, Jane N T; Peeters, Mariëlle A C; Hilberink, Sander R; Ista, Erwin; van Staa, AnneLoes

    2016-01-01

    Introduction To support young people in their transition to adulthood and transfer to adult care, a number of interventions have been developed. One particularly important intervention is the transition clinic (TC), where paediatric and adult providers collaborate. TCs are often advocated as best practices in transition care for young people with chronic conditions, but little is known about TC models and effects. The proposed study aims to gain insight into the added value of a TC compared with usual care (without a TC). Methods and analysis We propose a mixed-methods study with a retrospective controlled design consisting of semistructured interviews among healthcare professionals, observations of consultations with young people, chart reviews of young people transferred 2–4 years prior to data collection and questionnaires among the young people included in the chart reviews. Qualitative data will be analysed through thematic analysis and results will provide insights into structures and daily routines of TCs, and experienced barriers and facilitators in transitional care. Quantitatively, within-group differences on clinical outcomes and healthcare use will be studied over the four measurement moments. Subsequently, comparisons will be made between intervention and control groups on all outcomes at all measurement moments. Primary outcomes are ‘no-show after transfer’ (process outcome) and ‘experiences and satisfaction with the transfer’ (patient-reported outcome). Secondary outcomes consider clinical outcomes, healthcare usage, self-management outcomes and perceived quality of care. Ethics The Medical Ethical Committee of the Erasmus Medical Centre approved the study protocol (MEC-2014-246). Dissemination Study results will be disseminated through peer-reviewed journals and conferences. The study started in September 2014 and will continue until December 2016. The same study design will be used in a national study in 20 diabetes settings (2016

  8. Microfluidic chips for the study of cell migration under the effect of chemicals

    NASA Astrophysics Data System (ADS)

    Kukhtevich, I. V.; Belousov, K. I.; Bukatin, A. S.; Chubinskiy-Nadezhdin, V. I.; Vasileva, V. Yu.; Negulyaev, Yu. A.; Evstrapov, A. A.

    2016-05-01

    Numerical simulation of the formation of a chemoattractant gradient in reaction chambers of a chip having different geometries enabled the determination of a structure suitable for the study of cell migration, in accordance with which hybrid polymer-glass microfluidic devices were manufactured. Verification of the procedures of alignment of cells in the reaction chamber of the chip by centrifugal force and subsequent culturing of the cells showed that microfluidic chips can be used to study cell migration under the effect of the chemoattractant gradient in vitro.

  9. Critical Illness Outcome Study: An Observational Study on Protocols and Mortality in Intensive Care Units

    PubMed Central

    Ali, Naeem A.; Gutteridge, David; Shahul, Sajid; Checkley, William; Sevransky, Jonathan; Martin, Greg S.

    2014-01-01

    Introduction Many individual Intensive Care Unit (ICU) characteristics have been associated with patient outcomes, including staffing, expertise, continuity and team structure. Separately, many aspects of clinical care in ICUs have been operationalized through the development of complex treatment protocols. The United State Critical Illness and Injury Trials Group-Critical Illness Outcomes Study (USCIITG-CIOS) was designed to determine whether the extent of protocol availability and use in ICUs is associated with hospital survival in a large cohort of United States ICUs. Here, we describe the study protocol and analysis plan approved by the USCIITG-CIOS Steering Committee. Methods USCIITG-CIOS is a prospective, observational, ecological multi-centered “cohort” study of mixed ICUs in the U.S. The data collected include organizational information for the ICU (e.g., protocol availability and utilization, multi-disciplinary staffing assessment) and patient level information (e.g. demographics, acute and chronic medical conditions). The primary outcome is all-cause hospital mortality, with the objective being to determine whether there is an association between protocol number and hospital mortality for ICU patients. USCIITG-CIOS is powered to detect a 3% difference in crude hospital mortality between high and low protocol use ICUs, dichotomized according to protocol number at the median. The analysis will utilize regression modeling to adjust for outcome clustering by ICU, with secondary linear analysis of protocol number and mortality and a variety of a priori planned ancillary studies. There are presently 60 ICUs participating in USCIITG-CIOS to enroll approximately 6,000 study subjects. Conclusions USCIITG-CIOS is a large multicentric study examining the effect of ICU protocol use on patient outcomes. The primary results of this study will inform our understanding of the relationship between protocol availability, use, and patient outcomes in the ICU. Moreover

  10. Individual empowerment in overweight and obese patients: a study protocol

    PubMed Central

    Struzzo, Pierluigi; Fumato, Raffaella; Tillati, Silvia; Cacitti, Anita; Gangi, Fabrizio; Stefani, Alessia; Torcutti, Alessia; Crapesi, Lucia; Tubaro, Gianni; Balestrieri, Matteo

    2013-01-01

    Introduction Obesity is a growing health problem in Europe and it causes many diseases. Many weight-reducing methods are reported in medical literature, but none of them proved to be effective in maintaining the results achieved over time. Self-empowerment can be an important innovative method, but an effectiveness study is necessary. In order to standardise the procedures for a randomised controlled study, a pilot study will be run to observe, measure and evaluate the effects of a period of self-empowerment group treatment on overweight/obese patients. Methods and analysis Non-controlled, experimental, pilot study. A selected group of patients with body mass index >25, with no severe psychiatric disorders, with no aesthetic or therapeutic motivation will be included in the study. A set of quantitative and qualitative measures will be utilised to evaluate the effects of a self-empowerment course in a 12 month time. Group therapy and medical examinations will also complete this observational phase. At the end of this pilot study, a set of appropriate measures and procedures to determine the effectiveness of individual empowerment will be identified and agreed among the different professional figures. Results will be recorded and analysed to start a randomised controlled trial to evaluate the effectiveness of the proposed methodology. Ethics and dissemination This protocol was approved by the local Ethics Committee of Udine in March 2012. The findings of the trial will be disseminated through peer-reviewed journals, national and international conference presentations and public events involving the local administrations of the towns where the trial participants are resident. Trial Registration http://www.clinicalstrials.gov identifier NCT01644708. PMID:23676799

  11. How to design a (good) epidemiological observational study: epidemiological research protocol at a glance.

    PubMed

    Fronteira, Ines

    2013-01-01

    In this article, we propose a general structure for designing a research protocol of an observational epidemiological study. We start by highlighting the importance of the research protocol, namely in accounting for some bias and guaranteeing methodologic rigor and study reproductability. Next, we reflect on some of the essential elements of a research protocol no matter its objective. We further present some specific issues to be included according to the type of study: cross-sectional, case-control and cohort.

  12. Study on failure analysis of array chip components in IRFPA

    NASA Astrophysics Data System (ADS)

    Zhang, Xiaonan; He, Yingjie; Li, Jinping

    2016-10-01

    Infrared focal plane array detector has advantages of strong anti-interference ability and high sensitivity. Its size, weight and power dissipation has been noticeably decreased compared to the conventional infrared imaging system. With the development of the detector manufacture technology and the cost reduction, IRFPA detector has been widely used in the military and commercial fields. Due to the restricting of array chip manufacturing process and material defects, the fault phenomenon such as cracking, bad pixel and abnormal output was showed during the test, which restricts the performance of the infrared detector imaging system, and these effects are gradually intensified with the expanding of the focal plane array size and the shrinking of the pixel size. Based on the analysis of the test results for the infrared detector array chip components, the fault phenomenon was classified. The main cause of the chip component failure is chip cracking, bad pixel and abnormal output. The reason of the failure has been analyzed deeply. According to analyze the mechanism of the failure, a series of measures which contain filtrating materials and optimizing the manufacturing process of array chip components were used to improve the performance of the chip components and the test pass rate, which is used to meet the needs of the detector performance.

  13. A Protocol for Conducting Rainfall Simulation to Study Soil Runoff

    PubMed Central

    Kibet, Leonard C.; Saporito, Louis S.; Allen, Arthur L.; May, Eric B.; Kleinman, Peter J. A.; Hashem, Fawzy M.; Bryant, Ray B.

    2014-01-01

    Rainfall is a driving force for the transport of environmental contaminants from agricultural soils to surficial water bodies via surface runoff. The objective of this study was to characterize the effects of antecedent soil moisture content on the fate and transport of surface applied commercial urea, a common form of nitrogen (N) fertilizer, following a rainfall event that occurs within 24 hr after fertilizer application. Although urea is assumed to be readily hydrolyzed to ammonium and therefore not often available for transport, recent studies suggest that urea can be transported from agricultural soils to coastal waters where it is implicated in harmful algal blooms. A rainfall simulator was used to apply a consistent rate of uniform rainfall across packed soil boxes that had been prewetted to different soil moisture contents. By controlling rainfall and soil physical characteristics, the effects of antecedent soil moisture on urea loss were isolated. Wetter soils exhibited shorter time from rainfall initiation to runoff initiation, greater total volume of runoff, higher urea concentrations in runoff, and greater mass loadings of urea in runoff. These results also demonstrate the importance of controlling for antecedent soil moisture content in studies designed to isolate other variables, such as soil physical or chemical characteristics, slope, soil cover, management, or rainfall characteristics. Because rainfall simulators are designed to deliver raindrops of similar size and velocity as natural rainfall, studies conducted under a standardized protocol can yield valuable data that, in turn, can be used to develop models for predicting the fate and transport of pollutants in runoff. PMID:24748061

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

    PubMed Central

    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

  15. Protocol for fir tree sampling for provenance studies

    NASA Astrophysics Data System (ADS)

    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.

  16. Health Auctions: a Valuation Experiment (HAVE) study protocol

    PubMed Central

    Kularatna, Sanjeewa; Petrie, Dennis; Scuffham, Paul A; Byrnes, Joshua

    2016-01-01

    Introduction Quality-adjusted life years are derived using health state utility weights which adjust for the relative value of living in each health state compared with living in perfect health. Various techniques are used to estimate health state utility weights including time-trade-off and standard gamble. These methods have exhibited limitations in terms of complexity, validity and reliability. A new composite approach using experimental auctions to value health states is introduced in this protocol. Methods and analysis A pilot study will test the feasibility and validity of using experimental auctions to value health states in monetary terms. A convenient sample (n=150) from a population of university staff and students will be invited to participate in 30 auction sets with a group of 5 people in each set. The 9 health states auctioned in each auction set will come from the commonly used EQ-5D-3L instrument. At most participants purchase 2 health states, and the participant who acquires the 2 ‘best’ health states on average will keep the amount of money they do not spend in acquiring those health states. The value (highest bid and average bid) of each of the 24 health states will be compared across auctions to test for reliability across auction groups and across auctioneers. A test retest will be conducted for 10% of the sample to assess reliability of responses for health states auctions. Feasibility of conducting experimental auctions to value health states will also be examined. The validity of estimated health states values will be compared with published utility estimates from other methods. This pilot study will explore the feasibility, reliability and validity in using experimental auction for valuing health states. Ethics and dissemination Ethical clearance was obtained from Griffith University ethics committee. The results will be disseminated in peer-reviewed journals and major international conferences. PMID:27056589

  17. A Comparative experimental study of media access protocols for wireless radio networks

    SciTech Connect

    Barrett, C. L.; Drozda, M.; Marathe, M. V.

    2001-05-24

    We conduct a comparative experimental analysis of three well known media access protocols: 802.11, CSMA, and MACA for wireless radio networks. Both fixed and ad-hoc networks are considered. The experimental analysis was carried out using GloMoSim: a tool for simulating wireless networks. The main focus of experiments was to study how (i) the size of the network, (ii) number of open connections, (iii) the spatial location of individual connections, (iv) speed with which individual nodes move and (v) protocols higher up in the protocol stack (e,g. routing layer) affect the performance of the media access sublayer protocols. The performance of the protocols was measured w.r.t. three important parameters: (1) number of received packets, (2) average latency of each packet, and (3) throughput. The following general qualitative conclusions were obtained; some of the conclusions reinforce the earlier claims by other researchers. (1) Although 802.11 performs better than the other two protocols with respect to fairness of transmission, packets dropped, and latency, its performance is found to (i) show a lot of variance with changing input parameters and (ii) the overall performance still leaves a lot of room for improvement. (2) CSMA does not perform too well under the fairness criteria, however, was the best in terms of the latency criteria. (3) MACA also shows fairness problems and has poor performance at high packet injection rates. (4) Protocols in the higher level of the protocol stack affect the MAC layer performance. The main general implications of our work is two folds: (1) No single protocol dominated the other protocols across various measures of efficiency. This motivates the design of a new class of parameterized protocols that adapt to changes in the network connectivity and loads. We refer to these class of protocols as parameterized dynamically adaptive efficient protocols and as a first step suggest key design requirements for such a class of protocols. (2

  18. Improving outpatient safety through effective electronic communication: a study protocol

    PubMed Central

    Hysong, Sylvia J; Sawhney, Mona K; Wilson, Lindsey; Sittig, Dean F; Esquivel, Adol; Watford, Monica; Davis, Traber; Espadas, Donna; Singh, Hardeep

    2009-01-01

    Background Health information technology and electronic medical records (EMRs) are potentially powerful systems-based interventions to facilitate diagnosis and treatment because they ensure the delivery of key new findings and other health related information to the practitioner. However, effective communication involves more than just information transfer; despite a state of the art EMR system, communication breakdowns can still occur. [1-3] In this project, we will adapt a model developed by the Systems Engineering Initiative for Patient Safety (SEIPS) to understand and improve the relationship between work systems and processes of care involved with electronic communication in EMRs. We plan to study three communication activities in the Veterans Health Administration's (VA) EMR: electronic communication of abnormal imaging and laboratory test results via automated notifications (i.e., alerts); electronic referral requests; and provider-to-pharmacy communication via computerized provider order entry (CPOE). Aim Our specific aim is to propose a protocol to evaluate the systems and processes affecting outcomes of electronic communication in the computerized patient record system (related to diagnostic test results, electronic referral requests, and CPOE prescriptions) using a human factors engineering approach, and hence guide the development of interventions for work system redesign. Design This research will consist of multiple qualitative methods of task analysis to identify potential sources of error related to diagnostic test result alerts, electronic referral requests, and CPOE; this will be followed by a series of focus groups to identify barriers, facilitators, and suggestions for improving the electronic communication system. Transcripts from all task analyses and focus groups will be analyzed using methods adapted from grounded theory and content analysis. PMID:19781075

  19. Chip, Chip, Hooray!

    ERIC Educational Resources Information Center

    Kelly, Susan

    2001-01-01

    Presents a science laboratory using different brands of potato chips in which students test their oiliness, size, thickness, saltiness, quality, and cost, then analyze the results to determine the best chip. Gives a brief history of potato chips. (YDS)

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

    PubMed Central

    Dolor, Rowena J; Yancy, William S; Owen, William F; Matchar, David B; Samsa, Gregory P; Pollak, Kathryn I; Lin, Pao-Hwa; Ard, Jamy D; Prempeh, Maxwell; McGuire, Heather L; Batch, Bryan C; Fan, William; Svetkey, Laura P

    2009-01-01

    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 providers and the

  1. Consumption study and identification of methyl salicylate in spicy cassava chips

    NASA Astrophysics Data System (ADS)

    Nirjana, Marlene; Anggadiredja, Kusnandar; Damayanti, Sophi

    2015-09-01

    Spicy cassava chips is a popular snack. However, some news in electronic media reported addition of balsam which is a banned food additives in that product to give extra spicy flavor. This study aimed to determine ITB students' pattern of consumption, health problems caused by spicy chips consumption, and knowledge about illicit use of food additives in that product, and identify the main content of balsam namely methyl salicylate in 10 samples of spicy cassava chips taken from inside and outside about ITB campus. A total of 300 questionnaires distributed to ITB students then data processing was performed. Spicy cassava chips sample macerated in 50 mL of methanol for 24 hours at room temperature, filtered and analyzed using gas chromatography capillary column with OV-1, nitrogen carrier gas and flame ionization detector. Based on questionnaires, 292 (97%) of 300 respondents had consumed spicy chips. A total of 247 (85%) from 292 respondents spicy chips consumed less than 3 times a week. A total of 195 respondents (67%) had experienced health problems after eating spicy chips. There were 137 (47%) of the 292 respondents who knew about the illicit addition of food additives into spicy chips; only 35 respondents (12%) who knew about balsam's addition. There were 126 respondents (43%) who did not pay attention to their health because they will keep eating spicy chips despite the addition of banned food additives. Through the verification of the standard addition method in gas chromatography system with a hydrogen pressure of 1.5 bar, injector temperature 200 °C, detector temperature 230 °C, oven temperature 60 °C for 2 minutes and then increased to 230 °C with rate 6 °C/menit; linearity, limit of detection, limit of quantitation, accuracy, precision, and specificity parameters met the acceptance limits. From 10 spicy cassava chips samples which were analyzed, they did not reveal any content of methyl salicylate. Methyl salicylate contained in the positive control

  2. Consumption study and identification of methyl salicylate in spicy cassava chips

    SciTech Connect

    Nirjana, Marlene Anggadiredja, Kusnandar; Damayanti, Sophi

    2015-09-30

    Spicy cassava chips is a popular snack. However, some news in electronic media reported addition of balsam which is a banned food additives in that product to give extra spicy flavor. This study aimed to determine ITB students’ pattern of consumption, health problems caused by spicy chips consumption, and knowledge about illicit use of food additives in that product, and identify the main content of balsam namely methyl salicylate in 10 samples of spicy cassava chips taken from inside and outside about ITB campus. A total of 300 questionnaires distributed to ITB students then data processing was performed. Spicy cassava chips sample macerated in 50 mL of methanol for 24 hours at room temperature, filtered and analyzed using gas chromatography capillary column with OV-1, nitrogen carrier gas and flame ionization detector. Based on questionnaires, 292 (97%) of 300 respondents had consumed spicy chips. A total of 247 (85%) from 292 respondents spicy chips consumed less than 3 times a week. A total of 195 respondents (67%) had experienced health problems after eating spicy chips. There were 137 (47%) of the 292 respondents who knew about the illicit addition of food additives into spicy chips; only 35 respondents (12%) who knew about balsam’s addition. There were 126 respondents (43%) who did not pay attention to their health because they will keep eating spicy chips despite the addition of banned food additives. Through the verification of the standard addition method in gas chromatography system with a hydrogen pressure of 1.5 bar, injector temperature 200 °C, detector temperature 230 °C, oven temperature 60 °C for 2 minutes and then increased to 230 °C with rate 6 °C/menit; linearity, limit of detection, limit of quantitation, accuracy, precision, and specificity parameters met the acceptance limits. From 10 spicy cassava chips samples which were analyzed, they did not reveal any content of methyl salicylate. Methyl salicylate contained in the positive

  3. Electrotaxis Studies of Lung Cancer Cells using a Multichannel Dual-electric-field Microfluidic Chip.

    PubMed

    Hou, Hsien-San; Chang, Hui-Fang; Cheng, Ji-Yen

    2015-12-29

    The behavior of directional cell migration under a direct current electric-field (dcEF) is referred to as electrotaxis. The significant role of physiological dcEF in guiding cell movement during embryo development, cell differentiation, and wound healing has been demonstrated in many studies. By applying microfluidic chips to an electrotaxis assay, the investigation process is shortened and experimental errors are minimized. In recent years, microfluidic devices made of polymeric substances (e.g., polymethylmethacrylate, PMMA, or acrylic) or polydimethylsiloxane (PDMS) have been widely used in studying the responses of cells to electrical stimulation. However, unlike the numerous steps required to fabricate a PDMS device, the simple and rapid construction of the acrylic microfluidic chip makes it suitable for both device prototyping and production. Yet none of the reported devices facilitate the efficient study of the simultaneous chemical and dcEF effects on cells. In this report, we describe our design and fabrication of an acrylic-based multichannel dual-electric-field (MDF) chip to investigate the concurrent effect of chemical and electrical stimulation on lung cancer cells. The MDF chip provides eight combinations of electrical/chemical stimulations in a single test. The chip not only greatly shortens the required experimental time but also increases accuracy in electrotaxis studies.

  4. A comparative study of wireless sensor networks and their routing protocols.

    PubMed

    Bhattacharyya, Debnath; Kim, Tai-hoon; Pal, Subhajit

    2010-01-01

    Recent developments in the area of micro-sensor devices have accelerated advances in the sensor networks field leading to many new protocols specifically designed for wireless sensor networks (WSNs). Wireless sensor networks with hundreds to thousands of sensor nodes can gather information from an unattended location and transmit the gathered data to a particular user, depending on the application. These sensor nodes have some constraints due to their limited energy, storage capacity and computing power. Data are routed from one node to other using different routing protocols. There are a number of routing protocols for wireless sensor networks. In this review article, we discuss the architecture of wireless sensor networks. Further, we categorize the routing protocols according to some key factors and summarize their mode of operation. Finally, we provide a comparative study on these various protocols.

  5. A Comparative Study of Wireless Sensor Networks and Their Routing Protocols

    PubMed Central

    Bhattacharyya, Debnath; Kim, Tai-hoon; Pal, Subhajit

    2010-01-01

    Recent developments in the area of micro-sensor devices have accelerated advances in the sensor networks field leading to many new protocols specifically designed for wireless sensor networks (WSNs). Wireless sensor networks with hundreds to thousands of sensor nodes can gather information from an unattended location and transmit the gathered data to a particular user, depending on the application. These sensor nodes have some constraints due to their limited energy, storage capacity and computing power. Data are routed from one node to other using different routing protocols. There are a number of routing protocols for wireless sensor networks. In this review article, we discuss the architecture of wireless sensor networks. Further, we categorize the routing protocols according to some key factors and summarize their mode of operation. Finally, we provide a comparative study on these various protocols. PMID:22163483

  6. A numerical study of void nucleation and growth in a flip chip assembly process

    NASA Astrophysics Data System (ADS)

    Lee, Sangil; Zhou, Hao Min; Baldwin, Daniel F.

    2010-09-01

    In this study, we develop mathematical models and numerical simulations of void nucleation and growth induced by the chemical reaction in the flip chip package assembly process using a no-flow underfill. During the thermal assembly process, the underfill chemically reacts to the oxidation of solders I/O on the chip, achieving interconnection between chip and substrate. The chemical reaction causes a large number of voids in the thermal reflow process. The voids have been considered as a critical defect, reducing the life of the thermal reliability. This study investigates the mechanism of void nucleation and growth based on classical bubble nucleation theory and bubble dynamics, respectively. This knowledge can provide a theoretical foundation to achieve a void-free assembly process and high reliability performance.

  7. Fundamental study of microelectronic chip response under laser ultrasonic-interferometric inspection using C-scan method

    NASA Astrophysics Data System (ADS)

    Yang, Lei; Gong, Jie; Ume, I. Charles

    2014-02-01

    In modern surface mount packaging technologies, such as flip chips, chip scale packages, and ball grid arrays(BGA), chips are attached to the substrates/printed wiring board (PWB) using solder bump interconnections. The quality of solder bumps between the chips and the substrate/board is difficult to inspect. Laser ultrasonic-interferometric technique was proved to be a promising approach for solder bump inspection because of its noncontact and nondestructive characteristics. Different indicators extracted from received signals have been used to predict the potential defects, such as correlation coefficient, error ratio, frequency shifting, etc. However, the fundamental understanding of the chip behavior under laser ultrasonic inspection is still missing. Specifically, it is not sure whether the laser interferometer detected out-of-plane displacements were due to wave propagation or structural vibration when the chip was excited by pulsed laser. Plus, it is found that the received signals are chip dependent. Both challenges impede the interpretation of acquired signals. In this paper, a C-scan method was proposed to study the underlying phenomenon during laser ultrasonic inspection. The full chip was inspected. The response of the chip under laser excitation was visualized in a movie resulted from acquired signals. Specifically, a BGA chip was investigated to demonstrate the effectiveness of this method. By characterizing signals using discrete wavelet transform(DWT), both ultrasonic wave propagation and vibration were observed. Separation of them was successfully achieved using ideal band-pass filter and visualized in resultant movies, too. The observed ultrasonic waves were characterized and their respective speeds were measured by applying 2-D FFT. The C-scan method, combined with different digital signal processing techniques, was proved to be an very effective methodology to learn the behavior of chips under laser excitation. This general procedure can be

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

    PubMed

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

    2017-04-12

    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.

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

    PubMed Central

    2011-01-01

    Background There is widespread interest in measuring organizational readiness to implement evidence-based practices in clinical care. However, there are a number of challenges to validating organizational measures, including inferential bias arising from the halo effect and method bias - two threats to validity that, while well-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. Objectives Our objective is to conduct a comprehensive assessment of the psychometric properties of the Organizational Readiness to Change Assessment incorporating methods specifically to address threats from halo effect and method bias. Methods and Design We will conduct three sets of analyses using longitudinal, secondary data from four partner projects, each testing interventions to improve the implementation of an evidence-based clinical practice. Partner projects field the Organizational Readiness to Change Assessment at baseline (n = 208 respondents; 53 facilities), and prospectively assesses the degree to which the evidence-based practice is implemented. We will conduct predictive and concurrent validities using hierarchical linear modeling and multivariate regression, respectively. For predictive validity, the outcome is the change from baseline to follow-up in the use of the evidence-based practice. We will use intra-class correlations derived from hierarchical linear models to assess inter-rater reliability. Two partner projects will also field measures of job satisfaction for convergent and discriminant validity analyses, and will field Organizational Readiness to Change Assessment measures at follow-up for concurrent validity (n = 158 respondents; 33 facilities). Convergent and discriminant validities will test associations between organizational readiness and different aspects of job

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

    USGS Publications Warehouse

    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 <2-mm fraction of each sample was analyzed for Al, Ca, Fe, K, Mg, Na, S, Ti, Ag, As, Ba, Be, Bi, Cd, Ce, Co, Cr, Cs, Cu, Ga, In, La, Li, Mn, Mo, Nb, Ni, P, Pb, Rb, Sb, Sc, Sn, Sr, Te, Th, Tl, U, V, W, Y, and Zn by inductively coupled plasma-mass spectrometry and inductively coupled plasma-atomic emission spectrometry following a near-total digestion in a mixture of HCl, HNO3, HClO4, and HF. Separate methods were used for Hg, Se, total C, and carbonate-C on this same size fraction. Only Ag, In, and Te had a large percentage of concentrations below the detection limit. Quality control (QC) of the analyses was monitored at three levels: the laboratory performing 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

  11. Studies on spectroscopy of glycerol in THz range using microfluidic chip-integrated micropump

    NASA Astrophysics Data System (ADS)

    Su, Bo; Han, Xue; Wu, Ying; Zhang, Cunlin

    2014-11-01

    Terahertz time-domain spectroscopy (THz-TDS) is a detection method of biological molecules with label-free, non-ionizing, non-intrusive, no pollution and real-time monitoring. But owing to the strong THz absorption by water, it is mainly used in the solid state detection of biological molecules. In this paper, we present a microfluidic chip technique for detecting biological liquid samples using the transmission type of THz-TDS system. The microfluidic channel of the microfluidic chip is fabricated in the quartz glass using Micro-Electro-Mechanical System (MEMS) technology and sealed with polydimethylsiloxane (PDMS) diaphragm. The length, width and depth of the microfluidic channel are 25mm, 100μm and 50μm, respectively. The diameter of THz detection zone in the microfluidic channel is 4mm. The thicknesses of quartz glass and PDMS diaphragm are 1mm and 250μm, individually. Another one of the same quartz glass is used to bond with the PDMS for the rigidity and air tightness of the microfluidic chip. In order to realize the automation of sampling and improve the control precise of fluid, a micropump, which comprises PDMS diaphragm, pump chamber, diffuser and nozzle and flat vibration motor, is integrated on the microfluidic chip. The diffuser and nozzle are fabricated on both sides of the pump chamber, which is covered with PDMS diaphragm. The flat vibration motor is stuck on the PDMS diaphragm as the actuator. We study the terahertz absorption spectroscopy characteristics of glycerol with the concentration of 98% in the microfluidic chip by the aid of the THz-TDS system, and the feasibility of the microfluidic chip for the detection of liquid samples is proved.

  12. The Oxford Participation and Activities Questionnaire: study protocol

    PubMed Central

    Morley, David; Dummett, Sarah; Kelly, Laura; Dawson, Jill; Fitzpatrick, Ray; Jenkinson, Crispin

    2014-01-01

    Background With an ageing population and increasing demands on health and social care services, there is growing importance attached to the management of long-term conditions, including maximizing the cost-effectiveness of treatments. In line with this, there is increasing emphasis on the need to keep people both active and participating in daily life. Consequently, it is essential that well developed and validated instruments that can meaningfully assess levels of participation and activity are widely available. Current measures, however, are largely focused on disability and rehabilitation, and there is no measure of activity or participation for generic use that fully meets the standards set by regulatory bodies such as the US Food and Drug Administration. Here we detail a protocol for the development and validation of a new patient-reported outcome measure (PROM) for assessment of participation and activity in people experiencing a variety of health conditions, ie, the Oxford Participation and Activities Questionnaire (Ox-PAQ). The stages incorporated in its development are entirely in line with current regulations and represent best practice in the development of PROMs. Methods Development of the Ox-PAQ is theoretically grounded in the World Health Organization International Classification of Functioning, Disability, and Health. The project incorporates a new strategy of engaging with stakeholders from the outset in an attempt to identify those characteristics of PROMs considered most important to a range of potential users. Items will be generated through interviews with patients from a range of conditions. Pretesting of the instrument will be via cognitive interviews and focus groups. A postal survey will be conducted, with data subject to factor and Rasch analysis in order to identify appropriate dimensions and redundant items. Reliability will be assessed by Cronbach’s alpha and item-total correlations. A second, large-scale postal survey will follow

  13. Study of chip-breaking mechanisms in orthogonal cutting. Technical report, April 1, 1990--June 30, 1991

    SciTech Connect

    Strenkowski, J.S.

    1991-07-15

    This report summarizes the activities of the research project entitled {open_quotes}Study of Chip Breaking Mechanisms in Orthogonal Cutting{close_quotes}. The research effort took place from April 1990 to June 1991. The overall objective of the project was to develop a systematic procedure for gaining a more fundamental understanding of chip breaking mechanics. Central to this objective is a computer model that can simulate chip formation in orthogonal cutting. This model has been under development for the past seven years at NCSU. The model is based on an Eulerian formulation of the finite element technique. The model simulates the cutting process for various tool geometries over a wide range of cutting conditions. The model can be used to predict chip geometry, cutting forces, plastic strains, strain rates, and temperatures in the workpiece and chip, as well as temperatures in the tool itself. Of particular significance is that specific tool geometries can be simulated. Therefore, the model can be used to systematically evaluate the strains, strain rates, temperature, and geometry of the chip as a function of a specific chip-breaker tool design. These results can provide the crucial information necessary to formulate a fundamental understanding of the chip breaking mechanism over a wide range of operating conditions and workpiece materials.

  14. LAN (Local Area Network) interoperability study of protocols needed for distributed command and control

    NASA Astrophysics Data System (ADS)

    Elden, W. L.; Miller, A. L.; Morgan, S. L.; Romanzo, B. A.

    1985-03-01

    The study examined distrubuted processing requirements for strategic and tactical C3I systems, reviewed the characteristics and architectural issues for distributed processing global operating systems, compared the DoD and ISO networking protocol architecture models, the protocols for LAN's developed by the IEEE and ANSI, reviewed and conducted performance evaluation of Ethernet, DoD's Internet Protocal and Transmission Control Protocol and reported characteristics of CSMA/CD, Token Bus and Token Ring LAN's, reviewed three alternatives to using TCP for an intra-LAN protocol and examined the methods for employing gateway elements to interconnect LAN-based system elements. A comprehensive discussion of the results is given followed by a set of concise conclusions. Ten recommendations are given, providing a roadmap to guide the Air Force in developing C3I systems and LAN-based protocols. Three major areas are identified where future work is needed. A set of protocols and design approaches for internetworking is contained in a set of appendices.

  15. Characterizing Rat PNS Electrophysiological Response to Electrical Stimulation Using in vitro Chip-Based Human Investigational Platform (iCHIP)

    SciTech Connect

    Khani, Joshua; Prescod, Lindsay; Enright, Heather; Felix, Sarah; Osburn, Joanne; Wheeler, Elizabeth; Kulp, Kris

    2015-08-18

    Ex vivo systems and organ-on-a-chip technology offer an unprecedented approach to modeling the inner workings of the human body. The ultimate goal of LLNL’s in vitro Chip-based Human Investigational Platform (iCHIP) is to integrate multiple organ tissue cultures using microfluidic channels, multi-electrode arrays (MEA), and other biosensors in order to effectively simulate and study the responses and interactions of the major organs to chemical and physical stimulation. In this study, we focused on the peripheral nervous system (PNS) component of the iCHIP system. Specifically we sought to expound on prior research investigating the electrophysiological response of rat dorsal root ganglion cells (rDRGs) to chemical exposures, such as capsaicin. Our aim was to establish a protocol for electrical stimulation using the iCHIP device that would reliably elicit a characteristic response in rDRGs. By varying the parameters for both the stimulation properties – amplitude, phase width, phase shape, and stimulation/ return configuration – and the culture conditions – day in vitro and neural cell types - we were able to make several key observations and uncover a potential convention with a minimal number of devices tested. Future work will seek to establish a standard protocol for human DRGs in the iCHIP which will afford a portable, rapid method for determining the effects of toxins and novel therapeutics on the PNS.

  16. Situated Protocols: Studying a College Student's Writing in Classroom Contexts.

    ERIC Educational Resources Information Center

    McCarthy, Lucille

    A study examined the writing experiences of three college students during their freshman and sophomore years to determine how students in a classroom setting determine the writing requirements of that discipline and for that teacher, and how they go about producing their writing assignments. The study used ethnographic observation and interviews,…

  17. [The research protocol II: study designs in clinical research].

    PubMed

    Villasís-Keever, Miguel Ángel; Miranda-Novales, María Guadalupe

    2016-01-01

    In clinical research that takes place in health-care areas, most of the studies are performed with human beings as research subjects. The main objectives of these studies are to know the characteristics of one or more groups, the behavior of human diseases, the etiology or causes of diseases, to identify the best diagnostic tools, or to establish the best treatment for a condition or disease in particular. Additionally, some studies are classified as basic bio-medical research; in these investigations, the subjects of study are laboratory animals, tissues, cells, or molecules. In general terms, the objectives of these studies are to understand the physiology, pathogenesis, or biological mechanisms that could explain functions or alterations in one or more systems or body organs. This article will only address clinical research designs.

  18. Laboratory study on factors influencing nitrogen removal in marble chip biofilters incorporating nitritation and anammox.

    PubMed

    Tao, Wendong; Wen, Jianfeng; Norton, Christopher

    2011-01-01

    It remains challenging to integrate nitritation and anammox in ecologically engineered treatment systems such as passive biofilters that are packed with natural materials and have low energy inputs. This study explored the factors influencing nitritation-anammox through parallel operation of two laboratory-scale biofilters packed with large and small marble chips respectively. Clean marble chips (mainly CaCO3) had an alkalinity dissolution rate of 130 mg CaCO3/kg marble d when water pH approached 6.5. Marble chips effectively increased water pH and provided sufficient alkalinity to support nitritation-anammox in the biofilters. Ammonium and total nitrogen removal decreased by 47 and 26%, respectively, when nutrients were not amended to influent. An influent nitrite concentration above 8.9 mg N/L could inhibit anammox in thin biofilms of biofilters. Nitritation-anammox was enhanced with a hydraulic retention time of 2 d relative to 7 d, likely due to enhanced air entrainment. Size of marble chips rarely made a significant difference in nitrogen removal, possibly due to sufficient surface area available for bacterial attachment and alkalinity dissolution.

  19. Chromatin immunoprecipitation (ChIP) coupled to detection by quantitative real-time PCR to study transcription factor binding to DNA in Caenorhabditis elegans

    PubMed Central

    Mukhopadhyay, Arnab; Deplancke, Bart; Walhout, Albertha J M; Tissenbaum, Heidi A

    2009-01-01

    In order to determine how signaling pathways differentially regulate gene expression, it is necessary to identify the interactions between transcription factors (TFs) and their cognate cis-regulatory DNA elements. Here, we have outlined a chromatin immunoprecipitation (ChIP) protocol for use in whole Caenorhabditis elegans extracts. We discuss optimization of the procedure, including growth and harvesting of the worms, formaldehyde fixation, TF immunoprecipitation and analysis of bound sequences through real-time PCR. It takes ∼10–12 d to obtain the worm culture for ChIP; the ChIP procedure is spaced out over a period of 2.5 d with two overnight incubations. PMID:18388953

  20. Protocol Development and Preliminary Toxicity Study of CBRN Nanomaterials

    DTIC Science & Technology

    2013-12-05

    Program Army Institute of Public Health Specialty: 500C, Toxicity Tests Toxicology Study No. 87-XE-0EJ5-11 (FY12 Continuation) Use of trademarked name(s...toxicity by Microtox test and human cytotoxicity by NRU assay. These studies fill the data gaps and provide toxicity information useful in risk...Transepithelial Permeability (TEP) assays were developed and tested on EpiAirway. a 3-D human tracheal/bronchial epithelial equivalent. Further evaluation of the

  1. Older Persons’ Transitions in Care (OPTIC): a study protocol

    PubMed Central

    2012-01-01

    Background Changes in health status, triggered by events such as infections, falls, and geriatric syndromes, are common among nursing home (NH) residents and necessitate transitions between NHs and Emergency Departments (EDs). During transitions, residents frequently experience care that is delayed, unnecessary, not evidence-based, potentially unsafe, and fragmented. Furthermore, a high proportion of residents and their family caregivers report substantial unmet needs during transitions. This study is part of a program of research whose overall aim is to improve quality of care for frail older adults who reside in NHs. The purpose of this study is to identify successful transitions from multiple perspectives and to identify organizational and individual factors related to transition success, in order to inform improvements in care for frail elderly NH residents during transitions to and from acute care. Specific objectives are to: 1. define successful and unsuccessful elements of transitions from multiple perspectives; 2. develop and test a practical tool to assess transition success; 3. assess transition processes in a discrete set of transfers in two study sites over a one year period; 4. assess the influence of organizational factors in key practice locations, e.g., NHs, emergency medical services (EMS), and EDs, on transition success; and 5. identify opportunities for evidence-informed management and quality improvement decisions related to the management of NH – ED transitions. Methods/Design This is a mixed-methods observational study incorporating an integrated knowledge translation (IKT) approach. It uses data from multiple levels (facility, care unit, individual) and sources (healthcare providers, residents, health records, and administrative databases). Discussion Key to study success is operationalizing the IKT approach by using a partnership model in which the OPTIC governance structure provides for team decision-makers and researchers to participate

  2. Protocol and standard operating procedures for common use in a worldwide multicenter study on reference values.

    PubMed

    Ozarda, Yesim; Ichihara, Kiyoshi; Barth, Julian H; Klee, George

    2013-05-01

    The reference intervals (RIs) given in laboratory reports have an important role in aiding clinicians in interpreting test results in reference to values of healthy populations. In this report, we present a proposed protocol and standard operating procedures (SOPs) for common use in conducting multicenter RI studies on a national or international scale. The protocols and consensus on their contents were refined through discussions in recent C-RIDL meetings. The protocol describes in detail (1) the scheme and organization of the study, (2) the target population, inclusion/exclusion criteria, ethnicity, and sample size, (3) health status questionnaire, (4) target analytes, (5) blood collection, (6) sample processing and storage, (7) assays, (8) cross-check testing, (9) ethics, (10) data analyses, and (11) reporting of results. In addition, the protocol proposes the common measurement of a panel of sera when no standard materials exist for harmonization of test results. It also describes the requirements of the central laboratory, including the method of cross-check testing between the central laboratory of each country and local laboratories. This protocol and the SOPs remain largely exploratory and may require a reevaluation from the practical point of view after their implementation in the ongoing worldwide study. The paper is mainly intended to be a basis for discussion in the scientific community.

  3. A polymer lab-on-a-chip for genetic analysis using the arrayed primer extension on microarray chips.

    PubMed

    Marasso, Simone L; Mombello, Domenico; Cocuzza, Matteo; Casalena, Davide; Ferrante, Ivan; Nesca, Alessandro; Poiklik, Piret; Rekker, Kadri; Aaspollu, Anu; Ferrero, Sergio; Pirri, Candido F

    2014-10-01

    In this work a polymer lab-on-a-chip (LOC), fabricated through MEMS technology, was employed to execute a genetic protocol for the Single Nucleotide Polymorphisms (SNPs) detection. The LOC was made in Poly (methyl methacrylate) (PMMA) and has two levels: the lower one for the insertion and mixing of the reagents, the upper one for the interfacing with the DNA microarray chip. The hereditary hearing loss was chosen as case of study, since the demand for testing such a particular disorder is high and genetics behind the condition is quite clear. The Arrayed Primer EXtension (APEX) genetic protocol was implemented on the LOC to analyze the SNPs. A low density (for detection of up to 10 mutations) and a high density microarray chips (for detection of 245 mutations in 12 genes), containing the primers for the extension, were employed to carry out the APEX reaction on the LOC. Both the microarray chips provide a signal to noise ratio and efficiency comparable with a detection obtained in a conventional protocol in standard conditions. Moreover, significant reduction of the employed PCR volume (from 30 μL to 10 μL) was obtained using the low density chip.

  4. A protocol for conducting rainfall simulation to study soil runoff

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Rainfall is a driving force for the transport of environmental contaminants from agricultural soils to surficial water bodies via surface runoff. The objective of this study was to characterize the effects of antecedent soil moisture content on the fate and transport of surface applied commercial ur...

  5. Patient safety in Dutch primary care: a study protocol

    PubMed Central

    2010-01-01

    Background Insight into the frequency and seriousness of potentially unsafe situations may be the first step towards improving patient safety. Most patient safety attention has been paid to patient safety in hospitals. However, in many countries, patients receive most of their healthcare in primary care settings. There is little concrete information about patient safety in primary care in the Netherlands. The overall aim of this study was to provide insight into the current patient safety issues in Dutch general practices, out-of-hours primary care centres, general dental practices, midwifery practices, and allied healthcare practices. The objectives of this study are: to determine the frequency, type, impact, and causes of incidents found in the records of primary care patients; to determine the type, impact, and causes of incidents reported by Dutch healthcare professionals; and to provide insight into patient safety management in primary care practices. Design and methods The study consists of three parts: a retrospective patient record study of 1,000 records per practice type was conducted to determine the frequency, type, impact, and causes of incidents found in the records of primary care patients (objective one); a prospective component concerns an incident-reporting study in each of the participating practices, during two successive weeks, to determine the type, impact, and causes of incidents reported by Dutch healthcare professionals (objective two); to provide insight into patient safety management in Dutch primary care practices (objective three), we surveyed organizational and cultural items relating to patient safety. We analysed the incidents found in the retrospective patient record study and the prospective incident-reporting study by type of incident, causes (Eindhoven Classification Model), actual harm (severity-of-outcome domain of the International Taxonomy of Medical Errors in Primary Care), and probability of severe harm or death. Discussion

  6. Thyroid and Pregnancy in Tehran, Iran: Objectives and Study Protocol

    PubMed Central

    Nazarpour, Sima; Ramezani Tehrani, Fahimeh; Simbar, Masoumeh; Tohidi, Maryam; Azizi, Fereidoun

    2016-01-01

    Background Thyroid dysfunction is the second most common endocrine disease in females of reproductive age. There are controversial data on the adverse effect of subclinical thyroid dysfunctions on adverse feto-maternal outcomes. Objectives The current study aimed to identify the prevalence of thyroid dysfunction during pregnancy and to assess the effectiveness of treatment with levothyroxine on pregnancy outcomes of females with thyroid autoimmunity with or without subclinical thyroid dysfunction in Tehran, Iran. Patients and Methods The study encompassed two phases: 1) a population based cross sectional study using a cluster sampling method that screened first trimester pregnant females for thyroid disorders, 2) a double-blind randomized clinical trial to determine the effectiveness of levothyroxine on adverse pregnancy outcomes in females with thyroid autoimmunity with or without subclinical thyroid dysfunction. Pregnant females were assessed at their first prenatal visit for serum TSH, T4, T-uptake, TPOAb and urinary iodine following which they were classified as: 1) normal, 2) subclinical TPOAb negative and 3) subclinical/euthyroid TPOAb positive. Females in groups two and three were randomly divided into two groups: group A was treated with levothyroxine (LT4), and group B did not receive any treatment. There was a follow-up program for participants and rates of adverse pregnancy outcomes in the treated and untreated groups were measured. Results Results of the study provided reliable information regarding the prevalence of thyroid dysfunction among females in Tehran using universal thyroid screening, along with identification of the iodine status of their community. The study aimed to determine whether LT4 treatment exerts beneficial effects in females without overt thyroid dysfunction. PMID:27279833

  7. Protocol for studying cough frequency in people with pulmonary tuberculosis

    PubMed Central

    Bravard, Marjory A; Tracey, Brian H; López, José W; Comina, German; Zimic, Mirko; Coronel, Jorge; O'Neill Lee, Gwenyth; Caviedes, Luz; Luis Cabrera, Jose; Salas, Antonio; Ticona, Eduardo; Kirwan, Daniela E; Friedland, Jon S; Evans, Carlton A; Moore, David A; Gilman, Robert H

    2016-01-01

    Introduction Cough is a key symptom of tuberculosis (TB) as well as the main cause of transmission. However, a recent literature review found that cough frequency (number of coughs per hour) in patients with TB has only been studied once, in 1969. The main aim of this study is to describe cough frequency patterns before and after the start of TB treatment and to determine baseline factors that affect cough frequency in these patients. Secondarily, we will evaluate the correlation between cough frequency and TB microbiological resolution. Methods This study will select participants with culture confirmed TB from 2 tertiary hospitals in Lima, Peru. We estimated that a sample size of 107 patients was sufficient to detect clinically significant changes in cough frequency. Participants will initially be evaluated through questionnaires, radiology, microscopic observation drug susceptibility broth TB-culture, auramine smear microscopy and cough recordings. This cohort will be followed for the initial 60 days of anti-TB treatment, and throughout the study several microbiological samples as well as 24 h recordings will be collected. We will describe the variability of cough episodes and determine its association with baseline laboratory parameters of pulmonary TB. In addition, we will analyse the reduction of cough frequency in predicting TB cure, adjusted for potential confounders. Ethics and dissemination Ethical approval has been obtained from the ethics committees at each participating hospital in Lima, Peru, Asociación Benéfica PRISMA in Lima, Peru, the Universidad Peruana Cayetano Heredia in Lima, Peru and Johns Hopkins University in Baltimore, USA. We aim to publish and disseminate our findings in peer-reviewed journals. We also expect to create and maintain an online repository for TB cough sounds as well as the statistical analysis employed. PMID:27105713

  8. Patient involvement in research priorities (PIRE): a study protocol

    PubMed Central

    Jarden, Mary

    2016-01-01

    Introduction Patient involvement in healthcare has expanded from the clinical practice setting to include collaboration during the research process. There has been a growing international interest in patient and public involvement in setting research priorities to reduce the risk of discrepancy between what patients with cancer and their relatives experience as important unanswered questions and those which are actually researched. This study aims to challenge the conventional research process by inviting patients with life-threatening cancer (primary malignant brain tumours or acute leukaemia), relatives and patient organisations to join forces with clinical specialists and researchers to identify, discuss and prioritise supportive care and rehabilitation issues in future research. Methods and analysis This is an exploratory qualitative study comprising two sets of three focus group interviews (FGIs): one set for primary malignant brain tumours and the other for acute leukaemia. Separate FGIs will be carried out with patients and relatives including representation from patient organisations and clinical specialists to identify important unanswered questions and research topics within each group. The FGIs will be video/audio recorded, transcribed and thematically analysed. This study will contribute to a patient-centred research agenda that captures issues that patients, their relatives, clinical specialists and researchers consider important. Ethics and dissemination The study is registered at the Danish Data Protection Agency (number: 2012-58-0004) and the Scientific Ethics Review Committee of the Capital Region of Denmark (number: H-15001485). Papers will be published describing the methods applied and the supportive care and rehabilitation issues that are identified as important for future research. Trial registration number ISRCTN57131943; Pre-results. PMID:27221126

  9. Droplet evaporation study applied to DNA chip manufacturing.

    PubMed

    Dugas, Vincent; Broutin, Jérôme; Souteyrand, Eliane

    2005-09-27

    DNA chips are potentially powerful technologies for genotyping and gene expression profiling that rely on comparative analyses of up to thousands of "spots of analysis" on a glass support. The spot quality throughout the support influences spot-to-spot variations within an array and the repeatability of data across experiments. For glass slide DNA microarrays, droplets of DNA solution are deposited on functionalized glass slides and left to react through complete evaporation of the droplet. On hydrophobic flat surfaces, different modes of droplet evaporation can be attained. Under atmospheric pressure, water droplets tend to evaporate under two main regimes. Initially, the droplet flattens with a constant contact area, and then the droplet shrinks at a constant contact angle. As a result, the diameter and morphology of thousands of spots on microarrays are not uniform. This leads to poor and unreliable data processing results. In this work, we report the evaporation of an aqueous solution under a constant contact area mode. Evaporation under reduced pressure and the effect of reagent additives to the solution have been investigated. Video microscopy and digital image analysis techniques were applied to monitor the evaporation of the droplets. A mixture of surfactants was developed to maintain a constant area regime during evaporation and to form homogeneous spots. The control of some physicochemical properties (wetting, evaporation rate) of the droplet allows the formation of well-controlled spots compatible with DNA grafting. The influence of surfactant molecules on the mechanisms of evaporation is also discussed.

  10. [Design and arrangement of the CHIP (CHinese In Prato) study].

    PubMed

    Modesti, Pietro Amedeo; Han, Yang; Jing, Yang; Xiaoling, Wang; Mengyue, Zhang; Zihua, Yang; Jia, Guo; Perruolo, Eleonora; Bini, Lara; Camera, Maira; Biggeri, Annibale; Rapi, Stefano; Hongsheng, Chen; Li, Zhang; Zengli, Wang; Jianbin, Hu; Xiaoyue, Zhao; Zhao, Dong

    2014-01-01

    Following the rapid economic development, China is experiencing a progressive increase in the incidence of cardiovascular (CV) events and in the prevalence of CV risk factors. According to recent estimations, the prevalence of diabetes sharply increased from 1% in 1980 to 11% in 2013. Migration from China to Europe is now mainly concentrated in Countries of the Southern Europe, e.g., Italy and Spain. The largest Chinese community living in Italy is now settled in Prato, being also one of the largest Chinese community in Europe. Local authorities estimate a number of Chinese citizens living in Prato of over 40,000 individuals, including illegal immigrants. The availability of reliable data on the health needs of Chinese population is thus a recognised priority for the local health system. The creation of a participatory research where Chinese population directly participates in the formation of a group of citizens involved in designing and conducting the survey allows to overcome difficulties due to the lack of official demographic files. Secondly, and most important, this approach makes it possible to effectively pass a prevention message to an elusive population. The purpose of the CHIP (CHinese In Prato) survey is to investigate the prevalence of diabetes and cardiovascular risk factors among Chinese immigrants. Recruitment procedure was started on 8th July 2014.

  11. Radiation Doses of Various CT Protocols: a Multicenter Longitudinal Observation Study

    PubMed Central

    2016-01-01

    Emerging concerns regarding the hazard from medical radiation including CT examinations has been suggested. The purpose of this study was to observe the longitudinal changes of CT radiation doses of various CT protocols and to estimate the long-term efforts of supervising radiologists to reduce medical radiation. Radiation dose data from 11 representative CT protocols were collected from 12 hospitals. Attending radiologists had collected CT radiation dose data in two time points, 2007 and 2010. They collected the volume CT dose index (CTDIvol) of each phase, number of phases, dose length product (DLP) of each phase, and types of scanned CT machines. From the collected data, total DLP and effective dose (ED) were calculated. CTDIvol, total DLP, and ED of 2007 and 2010 were compared according to CT protocols, CT machine type, and hospital. During the three years, CTDIvol had significantly decreased, except for dynamic CT of the liver. Total DLP and ED were significantly decreased in all 11 protocols. The decrement was more evident in newer CT scanners. However, there was substantial variability of changes of ED during the three years according to hospitals. Although there was variability according to protocols, machines, and hospital, CT radiation doses were decreased during the 3 years. This study showed the effects of decreased CT radiation dose by efforts of radiologists and medical society. PMID:26908984

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

    NASA Technical Reports Server (NTRS)

    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.

  13. Cancer incidence in kidney transplant recipients: a study protocol

    PubMed Central

    2009-01-01

    Background Different publications show an increased incidence of neoplasms in renal transplant patients. The objective of this study is to determine the incidence of cancer in the recipients of renal transplants performed in the A Coruña Hospital (Spain) during the period 1981–2007. Methods/Design During the study period 1967 kidney transplants were performed, corresponding to 1710 patients. Patients with neoplasms prior to the transplant will be excluded (n = 38). A follow-up study was carried out in order to estimate cancer incidence after transplantation. For each patient, information included donor and recipient characteristics, patients and graft survival and cancer incidence after transplantation. Incident cancer is considered as new cases of cancer after the transplant with anatomopathological confirmation. Their location will be classified according to the ICD-9. The analysis will be calculated using the indirect standardisation method. Age-adjusted cancer incidence rates in the Spanish general population will be obtained from the Carlos III Health Institute, the National Epidemiology Centre of the Ministry of Science and Technology. Crude first, second and third-year post-transplantation cancer incidence rates will be calculated for male and female recipients. The number of cases of cancer at each site will be calculated from data in the clinical records. The expected number of cancers will be calculated from data supplied by the Carlos III Health Institute. For each tumour location we will estimate the standardized incidence ratios (SIRs), using sex-specific cancer incidence rates, by dividing the incidence rate for the transplant patients by the rate of the general population. The 95% confidence intervals of the SIRs and their associated p-values will be calculated by assuming that the observed cancers follow a Poisson distribution. Stratified analysis will be performed to examine the variation in the SIRs with sex and length of follow-up. Competing

  14. Study Protocol for the Fukushima Health Management Survey

    PubMed Central

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

    2012-01-01

    Background 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. Methods 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. Conclusions 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

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

    PubMed Central

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

    2014-01-01

    Introduction 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. Methods and analysis 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. Ethics and dissemination 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

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

    PubMed Central

    Simpson, Sharon; Barnes, Emma; Griffiths, Emily; Hood, Kerry; Cohen, David; Craddock, Nick; Jones, Ian; Smith, Daniel J

    2009-01-01

    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 ISRCTN81375447 PMID:19674448

  17. Lab-on-chip methodologies for the study of transport in porous media: energy applications.

    PubMed

    Berejnov, Viatcheslav; Djilali, Ned; Sinton, David

    2008-05-01

    We present a lab-on-chip approach to the study of multiphase transport in porous media. The applicability of microfluidics to biological and chemical analysis has motivated much development in lab-on-chip methodologies. Several of these methodologies are also well suited to the study of transport in porous media. We demonstrate the application of rapid prototyping of microfluidic networks with approximately 5000 channels, controllable wettability, and fluorescence-based analysis to the study of multiphase transport phenomena in porous media. The method is applied to measure the influence of wettability relative to network regularity, and to differentiate initial percolation patterns from active flow paths. Transport phenomena in porous media are of critical importance to many fields and particularly in many energy-related applications including liquid water transport in fuel cells, oil recovery, and CO(2) sequestration.

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

    PubMed Central

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

    2016-01-01

    Background 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. Methods 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. Results 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. Interpretation 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. PMID:27403212

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

    PubMed Central

    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 < .01). Protocol adaptations addressed barriers (e.g., health records approval, creating pocket versions, distributing with telephone messages). Chart audits revealed that protocols used were documented for 11% to 47% of patient calls. Sustained use requires organizational alignment and ongoing leadership support. Linking Evidence to Action Protocol uptake was similar to trials that have evaluated tailored interventions to improve professional practice by overcoming identified barriers. Collaborating with knowledge users facilitated interpretation of findings, aided protocol adaptation, and supported implementation. Protocol implementation in nursing requires a tailored approach. A multifaceted intervention approach increased nurses’ use

  20. A Field-Based Testing Protocol for Assessing Gross Motor Skills in Preschool Children: The Children's Activity and Movement in Preschool Study Motor Skills Protocol

    ERIC Educational Resources Information Center

    Williams, Harriet G.; Pfeiffer, Karin A.; Dowda, Marsha; Jeter, Chevy; Jones, Shaverra; Pate, Russell R.

    2009-01-01

    The purpose of this study was to develop a valid and reliable tool for use in assessing motor skills in preschool children in field-based settings. The development of the Children's Activity and Movement in Preschool Study Motor Skills Protocol included evidence of its reliability and validity for use in field-based environments as part of large…

  1. Organ-on-a-Chip Platforms for Studying Drug Delivery Systems

    PubMed Central

    Bhise, Nupura S.; Ribas, João; Manoharan, Vijayan; Zhang, Yu Shrike; Polini, Alessandro; Massa, Solange; Dokmeci, Mehmet R.; Khademhosseini, Ali

    2014-01-01

    Novel microfluidic tools allow new ways to manufacture and test drug delivery systems. Organ-on-a-chip systems – microscale recapitulations of complex organ functions – promise to improve the drug development pipeline. This review highlights the importance of integrating microfluidic networks with 3D tissue engineered models to create organ-on-a-chip platforms, able to meet the demand of creating robust preclinical screening models. Specific examples are cited to demonstrate the use of these systems for studying the performance of drug delivery vectors and thereby reduce the discrepancies between their performance at preclinical and clinical trials. We also highlight the future directions that need to be pursued by the research community for these proof-of-concept studies to achieve the goal of accelerating clinical translation of drug delivery nanoparticles. PMID:24818770

  2. Management of Chronic Periodontitis Using Chlorhexidine Chip and Diode Laser-A Clinical Study

    PubMed Central

    Ambooken, Majo; Mathew, Jayan Jacob; Issac, Annie Valayil; Kunju, Ajithkumar Parachalil; Parameshwaran, Renjith Athirkandathil

    2016-01-01

    Introduction The use of adjuncts like chlorhexidine local delivery and diode laser decontamination have been found to improve the clinical outcomes of scaling and root planing in non-surgical periodontal therapy in patients with chronic periodontitis. Aim To evaluate the effects of diode laser and chlorhexidine chip as adjuncts to scaling and root planing in the management of chronic periodontitis. The objective is to evaluate the outcome of chlorhexidine chip and diode laser as adjuncts to scaling and root planing on clinical parameters like Plaque Index, Gingival Index, probing pocket depth and clinical attachment level. Study and Design Department of Periodontics. Randomized clinical trial with split mouth design. Materials and Methods Fifteen chronic periodontitis patients having a probing pocket depth of 5mm-7mm on at least one interproximal site in each quadrant of the mouth were included in the study. After initial treatment, four sites in each patient were randomly subjected to scaling and root planing (control), chlorhexidine chip application (CHX chip group), diode laser (810 nm) decontamination (Diode laser group) or combination of both (Diode laser and chip group). Plaque Index (PI), Gingival Index (GI), probing pocket depth (PPD) and clinical attachment level (CAL) were assessed at baseline, one month and three months. Statistical analysis Results were statistically analysed using paired T test, one-way ANOVA, Tukey’s HSD test and repeated measure ANOVA. Results Post-treatment, the test and control sites showed a statistically significant reduction in PI, GI, PPD, and CAL. After three months, a mean PPD reduction of 1.47±0.52 mm in control group, 1.40±0.83 mm in diode laser group, 2.67±0.62 mm in CHX group, and 2.80± 0.77 mm in combination group was seen. The mean gain in CAL were 1.47±0.52 mm in the control group, 1.40±0.83 mm in diode laser group, 2.67± 0.49 mm in CHX group and 2.67± 0.82 mm in combination group respectively. The

  3. Atomic structure of machined semiconducting chips: An x-ray absorption spectroscopy study

    SciTech Connect

    Paesler, M.; Sayers, D.

    1988-12-01

    X-ray absorption spectroscopy (XAS) has been used to examine the atomic structure of chips of germanium that were produced by single point diamond machining. It is demonstrated that although the local (nearest neighbor) atomic structure is experimentally quite similar to that of single crystal specimens information from more distant atoms indicates the presence of considerable stress. An outline of the technique is given and the strength of XAS in studying the machining process is demonstrated.

  4. The CHIPS Randomized Controlled Trial (Control of Hypertension in Pregnancy Study)

    PubMed Central

    von Dadelszen, Peter; Singer, Joel; Lee, Terry; Rey, Evelyne; Ross, Susan; Asztalos, Elizabeth; Murphy, Kellie E.; Menzies, Jennifer; Sanchez, Johanna; Gafni, Amiram; Helewa, Michael; Hutton, Eileen; Koren, Gideon; Lee, Shoo K.; Logan, Alexander G.; Ganzevoort, Wessel; Welch, Ross; Thornton, Jim G.; Moutquin, Jean-Marie

    2016-01-01

    To determine whether clinical outcomes differed by occurrence of severe hypertension in the international CHIPS trial (Control of Hypertension in Pregnancy Study), adjusting for the interventions of “less tight” (target diastolic blood pressure [dBP] 100 mm Hg) versus “tight” control (target dBP 85 mm Hg). In this post-hoc analysis of CHIPS data from 987 women with nonsevere nonproteinuric preexisting or gestational hypertension, mixed effects logistic regression was used to compare the following outcomes according to occurrence of severe hypertension, adjusting for allocated group and the influence of baseline factors: CHIPS primary (perinatal loss or high-level neonatal care for >48 hours) and secondary outcomes (serious maternal complications), birth weight <10th percentile, preeclampsia, delivery at <34 or <37 weeks, platelets <100×109/L, elevated liver enzymes with symptoms, maternal length of stay ≥10 days, and maternal readmission before 6 weeks postpartum. Three hundred and thirty-four (34.1%) women in CHIPS developed severe hypertension that was associated with all outcomes examined except for maternal readmission (P=0.20): CHIPS primary outcome, birth weight <10th percentile, preeclampsia, preterm delivery, elevated liver enzymes (all P<0.001), platelets <100×109/L (P=0.006), and prolonged hospital stay (P=0.03). The association between severe hypertension and serious maternal complications was seen only in less tight control (P=0.02). Adjustment for preeclampsia (464, 47.3%) did not negate the relationship between severe hypertension and the CHIPS primary outcome (P<0.001), birth weight <10th percentile (P=0.005), delivery at <37 (P<0.001) or <34 weeks (P<0.001), or elevated liver enzymes with symptoms (P=0.02). Severe hypertension is a risk marker for adverse maternal and perinatal outcomes, independent of BP control or preeclampsia co-occurrence. Clinical Trial Registration— URL: http://pre-empt.cfri.ca/. Unique identifier: ISRCTN

  5. Improving post-stroke dysphagia outcomes through a standardized and multidisciplinary protocol: an exploratory cohort study.

    PubMed

    Gandolfi, Marialuisa; Smania, Nicola; Bisoffi, Giulia; Squaquara, Teresa; Zuccher, Paola; Mazzucco, Sara

    2014-12-01

    Stroke is a major cause of dysphagia. Few studies to date have reported on standardized multidisciplinary protocolized approaches to the management of post-stroke dysphagia. The aim of this retrospective cohort study was to evaluate the impact of a standardized multidisciplinary protocol on clinical outcomes in patients with post-stroke dysphagia. We performed retrospective chart reviews of patients with post-stroke dysphagia admitted to the neurological ward of Verona University Hospital from 2004 to 2008. Outcomes after usual treatment for dysphagia (T- group) were compared versus outcomes after treatment under a standardized diagnostic and rehabilitative multidisciplinary protocol (T+ group). Outcome measures were death, pneumonia on X-ray, need for respiratory support, and proportion of patients on tube feeding at discharge. Of the 378 patients admitted with stroke, 84 had dysphagia and were enrolled in the study. A significantly lower risk of in-hospital death (odds ratio [OR] 0.20 [0.53-0.78]), pneumonia (OR 0.33 [0.10-1.03]), need for respiratory support (OR 0.48 [0.14-1.66]), and tube feeding at discharge (OR 0.30 [0.09-0.91]) was recorded for the T+ group (N = 39) as compared to the T- group (N = 45). The adjusted OR showed no difference between the two groups for in-hospital death and tube feeding at discharge. Use of a standardized multidisciplinary protocolized approach to the management of post-stroke dysphagia may significantly reduce rates of aspiration pneumonia, in-hospital mortality, and tube feeding in dysphagic stroke survivors. Consistent with the study's exploratory purposes, our findings suggest that the multidisciplinary protocol applied in this study offers an effective model of management of post-stroke dysphagia.

  6. Effectiveness of enteral feeding protocol on clinical outcomes in critically ill patients: a study protocol for before-and-after design

    PubMed Central

    Zhang, Zhongheng; Li, Qian; Jiang, Lingzhi; Xie, Bo; Ji, Xiaowei; Lu, Jiahong; Jiang, Ronglin; Lei, Shu; Mao, Shihao; Ying, Lijun; Lu, Di; Si, Xiaoshui; He, Jianxin; Ji, Mingxia; Zhu, Jianhua; Chen, Guodong; Shao, Yadi; Xu, Yinghe; Lin, Ronghai; Zhang, Chao; Zhang, Weiwen; Luo, Jian; Lou, Tianzheng; He, Xuwei; Chen, Kun

    2016-01-01

    Introduction Enteral feed is an important component of nutritional therapy in critically ill patients and underfeeding has been associated with adverse outcomes. The article developed an enteral feeding protocol and planed a before-and-after comparative trial to explore whether implementation of enteral feeding protocol was able to improve clinical outcomes. Methods and analysis The study will be conducted in intensive care units (ICUs) of ten tertiary care academic centers. Critically ill patients expected to stay in ICU for over 3 days and require enteral nutrition (EN) were potentially eligible. This is a before-and-after study comprising three phases: The first phase is the period without enteral feeding protocol; the second phase involves four-week training program, and the last phase is to perform the protocol in participating centers. We plan to enroll a total of 350 patients to provide an 80% power and 0.05 error rate to detect a 15% reduction of mortality. The primary outcome is 28-day mortality. Ethics and dissemination Ethical approval to conduct the research has been obtained from all participating centers. Additionally, the results will be published in peer-reviewed journal. Trial registration The study was registered at International Standard Registered Clinical/soCial sTudy Number (ISRCTN) registry (ISRCTN10583582). PMID:27668228

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

    PubMed Central

    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

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

    PubMed

    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

  9. Systematic evaluation of patient-reported outcome (PRO) protocol content and reporting in UK cancer clinical trials: the EPiC study protocol

    PubMed Central

    Ahmed, Khaled; Kyte, Derek; Keeley, Thomas; Efficace, Fabio; Armes, Jo; Brown, Julia M; Calman, Lynn; Copland, Chris; Gavin, Anna; Glaser, Adam; Greenfield, Diana M; Lanceley, Anne; Taylor, Rachel; Velikova, Galina; Brundage, Michael; Mercieca-Bebber, Rebecca; King, Madeleine T

    2016-01-01

    Introduction Emerging evidence suggests that patient-reported outcome (PRO)-specific information may be omitted in trial protocols and that PRO results are poorly reported, limiting the use of PRO data to inform cancer care. This study aims to evaluate the standards of PRO-specific content in UK cancer trial protocols and their arising publications and to highlight examples of best-practice PRO protocol content and reporting where they occur. The objective of this study is to determine if these early findings are generalisable to UK cancer trials, and if so, how best we can bring about future improvements in clinical trials methodology to enhance the way PROs are assessed, managed and reported. Hypothesis: Trials in which the primary end point is based on a PRO will have more complete PRO protocol and publication components than trials in which PROs are secondary end points. Methods and analysis Completed National Institute for Health Research (NIHR) Portfolio Cancer clinical trials (all cancer specialities/age-groups) will be included if they contain a primary/secondary PRO end point. The NIHR portfolio includes cancer trials, supported by a range of funders, adjudged as high-quality clinical research studies. The sample will be drawn from studies completed between 31 December 2000 and 1 March 2014 (n=1141) to allow sufficient time for completion of the final trial report and publication. Two reviewers will then review the protocols and arising publications of included trials to: (1) determine the completeness of their PRO-specific protocol content; (2) determine the proportion and completeness of PRO reporting in UK Cancer trials and (3) model factors associated with PRO protocol and reporting completeness and with PRO reporting proportion. Ethics and dissemination The study was approved by the ethics committee at University of Birmingham (ERN_15-0311). Trial findings will be disseminated via presentations at local, national and international conferences, peer

  10. Creating a Community of Inquiry in Online Environments: An Exploratory Study on the Effect of a Protocol on Interactions within Asynchronous Discussions

    ERIC Educational Resources Information Center

    Zydney, Janet Mannheimer; deNoyelles, Aimee; Seo, Kay Kyeong-Ju

    2012-01-01

    The purpose of our research was to examine the influence of an online protocol on asynchronous discussions. A mixed-methods study compared two online graduate classes: one that used a protocol and one that did not use a protocol for the same discussion about a complex reading. Analysis of the data revealed that the online protocol more evenly…

  11. Plain packaging of cigarettes and smoking behavior: study protocol for a randomized controlled study

    PubMed Central

    2014-01-01

    Background Previous research on the effects of plain packaging has largely relied on self-report measures. Here we describe the protocol of a randomized controlled trial investigating the effect of the plain packaging of cigarettes on smoking behavior in a real-world setting. Methods/Design In a parallel group randomization design, 128 daily cigarette smokers (50% male, 50% female) will attend an initial screening session and be assigned plain or branded packs of cigarettes to smoke for a full day. Plain packs will be those currently used in Australia where plain packaging has been introduced, while branded packs will be those currently used in the United Kingdom. Our primary study outcomes will be smoking behavior (self-reported number of cigarettes smoked and volume of smoke inhaled per cigarette as measured using a smoking topography device). Secondary outcomes measured pre- and post-intervention will be smoking urges, motivation to quit smoking, and perceived taste of the cigarettes. Secondary outcomes measured post-intervention only will be experience of smoking from the cigarette pack, overall experience of smoking, attributes of the cigarette pack, perceptions of the on-packet health warnings, behavior changes, views on plain packaging, and the rewarding value of smoking. Sex differences will be explored for all analyses. Discussion This study is novel in its approach to assessing the impact of plain packaging on actual smoking behavior. This research will help inform policymakers about the effectiveness of plain packaging as a tobacco control measure. Trial registration Current Controlled Trials ISRCTN52982308 (registered 27 June 2013). PMID:24965551

  12. On shaky ground - A study of security vulnerabilities in control protocols

    SciTech Connect

    Byres, E. J.; Huffman, D.; Kube, N.

    2006-07-01

    The recent introduction of information technologies such as Ethernet R into nuclear industry control devices has resulted in significantly less isolation from the outside world. This raises the question of whether these systems could be attacked by malware, network hackers or professional criminals to cause disruption to critical operations in a manner similar to the impacts now felt in the business world. To help answer this question, a study was undertaken to test a representative control protocol to determine if it had vulnerabilities that could be exploited. A framework was created in which a test could express a large number of test cases in very compact formal language. This in turn, allowed for the economical automation of both the generation of selectively malformed protocol traffic and the measurement of device under test's (DUT) behavior in response to this traffic. Approximately 5000 protocol conformance tests were run against two major brands of industrial controller. More than 60 categories of errors were discovered, the majority of which were in the form of incorrect error responses to malformed traffic. Several malformed packets however, caused the device to respond or communicate in inappropriate ways. These would be relatively simple for an attacker to inject into a system and could result in the plant operator losing complete view or control of the control device. Based on this relatively small set of devices, we believe that the nuclear industry urgently needs to adopt better security robustness testing of control devices as standard practice. (authors)

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

    PubMed Central

    Sigilião, Lara Carvalho Freitas; Marquezan, Mariana; Elias, Carlos Nelson; Ruellas, Antônio Carlos; Sant'Anna, Eduardo Franzotti

    2015-01-01

    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. PMID:26560825

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

    PubMed Central

    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

  15. Soil-on-a-Chip: microfluidic platforms for environmental organismal studies.

    PubMed

    Stanley, Claire E; Grossmann, Guido; i Solvas, Xavier Casadevall; deMello, Andrew J

    2016-01-21

    Soil is the habitat of countless organisms and encompasses an enormous variety of dynamic environmental conditions. While it is evident that a thorough understanding of how organisms interact with the soil environment may have substantial ecological and economical impact, current laboratory-based methods depend on reductionist approaches that are incapable of simulating natural diversity. The application of Lab-on-a-Chip or microfluidic technologies to organismal studies is an emerging field, where the unique benefits afforded by system miniaturisation offer new opportunities for the experimentalist. Indeed, precise spatiotemporal control over the microenvironments of soil organisms in combination with high-resolution imaging has the potential to provide an unprecedented view of biological events at the single-organism or single-cell level, which in turn opens up new avenues for environmental and organismal studies. Herein we review some of the most recent and interesting developments in microfluidic technologies for the study of soil organisms and their interactions with the environment. We discuss how so-called "Soil-on-a-Chip" technology has already contributed significantly to the study of bacteria, nematodes, fungi and plants, as well as inter-organismal interactions, by advancing experimental access and environmental control. Most crucially, we highlight where distinct advantages over traditional approaches exist and where novel biological insights will ensue.

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

    NASA Astrophysics Data System (ADS)

    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

  17. On-chip dynamic stress control for cancer cell evolution study

    NASA Astrophysics Data System (ADS)

    Liu, Liyu; Austin, Robert

    2010-03-01

    The growth and spreading of cancer in host organisms is an evolutionary process. Cells accumulate mutations that help them adapt to changing environments and to obtain survival fitness. However, all cancer--promoting mutations do not occur at once. Cancer cells face selective environmental pressures that drive their evolution in stages. In traditional cancer studies, environmental stress is usually homogenous in space and difficult to change in time. Here, we propose a microfluidic chip employing embedded dynamic traps to generate dynamic heterogeneous microenvironments for cancer cells in evolution studies. Based on polydimethylsiloxane (PDMS) flexible diaphragms, these traps are able to enclose and shield cancer cells or expose them to external environmental stress. Digital controls for each trap determine the nutrition, antibiotics, CO2/O2 conditions, and temperatures to which trapped cells are subjected. Thus, the stress applied to cells can be varied in intensity and duration in each trap independently. The chip can also output cells from specific traps for sequencing and other biological analysis. Hence our design simultaneously monitors and analyzes cell evolution behaviors under dynamic stresses.

  18. Analysis of DNA-chip and antigen-chip data: studies of cancer, stem cells and autoimmune diseases

    NASA Astrophysics Data System (ADS)

    Domany, Eytan

    2005-07-01

    Biology has undergone a revolution during the past decade. Deciphering the human genome has opened new horizons, among which the advent of DNA microarrays has been perhaps the most significant. These miniature measuring devices report the levels at which tens of thousands of genes are expressed in a collection of cells of interest (such as tissue from a tumor). I describe here briefly this technology and present an example of how analysis of data obtained from such high throughput experiments provides insights of possible clinical and therapeutic relevance for Acute Lymphoblastic Leukemia. Next, I describe how gene expression data is used to deduce a new design principle, " Just In Case", used by stem cells. Finally I briefly review a different novel technology, of antigen chips, which provide a fingerprint of a subject's immune system and may become a predictive clinical tool. The work reviewed here was done in collaboration with numerous colleagues and students.

  19. Radiation Dose Index of Renal Colic Protocol CT Studies in the United States

    PubMed Central

    Lukasiewicz, Adam; Bhargavan-Chatfield, Mythreyi; Coombs, Laura; Ghita, Monica; Weinreb, Jeffrey; Gunabushanam, Gowthaman; Moore, Christopher L.

    2016-01-01

    Purpose To determine radiation dose indexes for computed tomography (CT) performed with renal colic protocols in the United States, including frequency of reduced-dose technique usage and any institutional-level factors associated with high or low dose indexes. Materials and Methods The Dose Imaging Registry (DIR) collects deidentified CT data, including examination type and dose indexes, for CT performed at participating institutions; thus, the DIR portion of the study was exempt from institutional review board approval and was HIPAA compliant. CT dose indexes were examined at the institutional level for CT performed with a renal colic protocol at institutions that contributed at least 10 studies to the registry as of January 2013. Additionally, patients undergoing CT for renal colic at a single institution (with institutional review board approval and informed consent from prospective subjects and waiver of consent from retrospective subjects) were studied to examine individual renal colic CT dose index patterns and explore relationships between patient habitus, demographics, and dose indexes. Descriptive statistics were used to analyze dose indexes, and linear regression and Spearman correlations were used to examine relationships between dose indexes and institutional factors. Results There were 49 903 renal colic protocol CT examinations conducted at 93 institutions between May 2011 and January 2013. Mean age ± standard deviation was 49 years ± 18, and 53.9% of patients were female. Institutions contributed a median of 268 (interquartile range, 77–699) CT studies. Overall mean institutional dose-length product (DLP) was 746 mGy · cm (effective dose, 11.2 mSv), with a range of 307–1497 mGy · cm (effective dose, 4.6–22.5 mSv) for mean DLPs. Only 2% of studies were conducted with a DLP of 200 mGy · cm or lower (a “reduced dose”) (effective dose, 3 mSv), and only 10% of institutions kept DLP at 400 mGy · cm (effective dose, 6 mSv) or less in at

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

    PubMed Central

    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 (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. PMID:28076466

  1. Implementation of enteral feeding protocol in an intensive care unit: Before-and-after study

    PubMed Central

    Padar, Martin; Uusvel, Gerli; Starkopf, Liis; Starkopf, Joel; Reintam Blaser, Annika

    2017-01-01

    AIM To determine the effects of implementing an enteral feeding protocol on the nutritional delivery and outcomes of intensive care patients. METHODS An uncontrolled, observational before-and-after study was performed in a tertiary mixed medical-surgical intensive care unit (ICU). In 2013, a nurse-driven enteral feeding protocol was developed and implemented in the ICU. Nutrition and outcome-related data from patients who were treated in the study unit from 2011-2012 (the Before group) and 2014-2015 (the After group) were obtained from a local electronic database, the national Population Registry and the hospital’s Infection Control Service. Data from adult patients, readmissions excluded, who were treated for at least 7 d in the study unit were analysed. RESULTS In total, 231 patients were enrolled in the Before and 249 in the After group. The groups were comparable regarding demographics, patient profile, and severity of illness. Fewer patients were mechanically ventilated on admission in the After group (86.7% vs 93.1% in the Before group, P = 0.021). The prevalence of hospital-acquired infections, length of ICU stay and ICU, 30- and 60-d mortality did not differ between the groups. Patients in the After group had a lower 90-d (P = 0.026) and 120-d (P = 0.033) mortality. In the After group, enteral nutrition was prescribed less frequently (P = 0.039) on day 1 but significantly more frequently on all days from day 3. Implementation of the feeding protocol resulted in a higher cumulative amount of enterally (P = 0.049) and a lower cumulative amount of parenterally (P < 0.001) provided calories by day 7, with an overall reduction in caloric provision (P < 0.001). The prevalence of gastrointestinal symptoms was comparable in both groups, as was the frequency of prokinetic use. Underfeeding (total calories < 80% of caloric needs, independent of route) was observed in 59.4% of the study days Before vs 76.9% After (P < 0.001). Inclusion in the Before group, previous

  2. Study on thermally reworkable underfills for flip chip, BGA, and CSP applications

    NASA Astrophysics Data System (ADS)

    Wang, Lejun

    Underfill is a polymeric material used in the flip-chip devices that fills the gap between an integrated circuit (IC) chip and an organic printed wiring board (PWB), and encapsulates the solder interconnects. This underfill material dramatically enhances the reliability of the flip-chip devices as compared to the non-underfilled devices. Current underfills are mainly epoxy-based materials that are not reworkable after curing, which places an obstacle in Flip-Chip on Board (FCOB) technology developments. Thermally reworkable underfill is not only the key material to address the non-reworkability of the FCOB packages, but it can also be used to enhance the board-level reliability of ball grid array (BGA) and chip scale package (CSP) devices without losing their good reworkability feature. In this work, three approaches for developing thermally reworkable underfills including syntheses of thermally degradable epoxies, incorporation of special additives into standard epoxy matrix, and utilization of thermoplastic-thermoset copolymers/blends are studied. Based on these studies, reworkable underfills are then developed. Reworkable underfills developed in-house and from commercial sources are then evaluated for their reworkability and reliability to the encapsulation of FCOB, BGA, and CSP. To begin with, various thermal degradable epoxies containing carbonate or carbamate linkdage are synthesized and characterized. Among them, two diepoxides that decompose around solder reflow temperature and have good overall properties are selected and formulated into reworkable underfills for conventional capillary-flow underfilling process. A group of additives named chemical blowing agents are identified to have the capability to make the epoxy removable under certain conditions when they are incorporated into a standard epoxy matrix. Interactions between the additives and the typical epoxy formulation are thoroughly studied for the purpose of identifying good additives that provide

  3. Calibration and data collection protocols for reliable lattice parameter values in electron pair distribution function (ePDF) studies

    DOE PAGES

    Abeykoon, A. M. Milinda; Hu, Hefei; Wu, Lijun; ...

    2015-02-01

    We explore and describe different protocols for calibrating electron pair distribution function (ePDF) measurements for quantitative studies on nano-materials. We find the most accurate approach to determine the camera-length is to use a standard calibration sample of Au nanoparticles from National Institute of Standards and Technology. Different protocols for data collection are also explored, as are possible operational errors, to find the best approaches for accurate data collection for quantitative ePDF studies.

  4. Testing a theory-based mobility monitoring protocol using in-home sensors: a feasibility study.

    PubMed

    Reeder, Blaine; Chung, Jane; Lazar, Amanda; Joe, Jonathan; Demiris, George; Thompson, Hilaire J

    2013-10-01

    Mobility is a key factor in the performance of many everyday tasks required for independent living as a person ages. The purpose of this mixed-methods study was to test a theory-based mobility monitoring protocol by comparing sensor-based measures to self-report measures of mobility and assess the acceptability of in-home sensors with older adults. Standardized instruments to measure physical, psychosocial, and cognitive parameters were administered to 8 community-dwelling older adults at baseline, 3-month, and 6-month visits. Semi-structured interviews to characterize acceptability of the technology were conducted at the 3-month and 6-month visits. Technical issues prevented comparison of sensor-based measures with self-report measures. In-home sensor technology for monitoring mobility is acceptable to older adults. Implementing our theory-based mobility monitoring protocol in a field study in the homes of older adults is a feasible undertaking but requires more robust technology for sensor-based measure validation.

  5. Rush allergen specific immunotherapy protocol in feline atopic dermatitis: a pilot study of four cats.

    PubMed

    Trimmer, Ann M; Griffin, Craig E; Boord, Mona J; Rosenkrantz, Wayne S

    2005-10-01

    Rush immunotherapy has been shown to be as safe as conventional immunotherapy in canine atopic patients. Rush immunotherapy has not been reported in the feline atopic patient. The purpose of this pilot study was to determine a safe protocol for rush immunotherapy in feline atopic patients. Four atopic cats diagnosed by history, physical examination and exclusion of appropriate differential diagnoses were included in the study. Allergens were identified via liquid phase immunoenzymatic testing (VARL: Veterinary Allergy Reference Labs, Pasadena, CA). Cats were premedicated with 1.5 mg triamcinolone orally 24 and 2 h prior to first injection and 10 mg hydroxyzine PO 24, 12 and 2 h prior to first injection. An intravenous catheter was placed prior to first injection. Allergen extracts (Greer Laboratories, Lenoir, North Carolina) were all administered subcutaneously at increasing protein nitrogen units (pnu) every 30 minutes for 5 h to maintenance dose of 15,000 pnus ml-1. Vital signs were assessed every 15 minutes. Two cats developed mild pruritus and the subsequent injection was delayed 30 minutes. No changes in either cat's vital signs were noted, nor was there any further pruritus. All four cats successfully completed rush immunotherapy. Two cats developed a dermal swelling on the dorsal neck one week later. In these four cats, this protocol appeared to be a safe regimen to reach maintenance therapy. A larger sample of feline patients is needed to determine the incidence of adverse reactions and to follow the success of ASIT based upon this method of induction.

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

    PubMed

    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.

  7. Pilot Study of the SPRINT Glycemic Control Protocol in a Hungarian Medical Intensive Care Unit

    PubMed Central

    Benyo, Balazs; Illyés, Attila; Némedi, Noémi Szabó; Le Compte, Aaron J.; Havas, Attila; Kovacs, Levente; Fisk, Liam; Shaw, Geoffrey M.; Chase, J. Geoffrey

    2012-01-01

    -patient median insulin administration was 3.0 (3.0–3.0) U/h and 7.1 (3.4–9.6) g/h dextrose. Higher carbohydrate nutrition formulas than were used in SPRINT are offset by slightly higher insulin administration in this study. Conclusions The glycemic performance shows that using the SPRINT protocol to guide insulin infusions and nutrition administration provided very good glycemic control in initial pilot testing, with no severe hypoglycemia. The overall design of the protocol was able to be generalized with good compliance and outcomes across geographically distinct clinical units, patients, and clinical practice. PMID:23294794

  8. The CHIPS Randomized Controlled Trial (Control of Hypertension in Pregnancy Study): Is Severe Hypertension Just an Elevated Blood Pressure?

    PubMed

    Magee, Laura A; von Dadelszen, Peter; Singer, Joel; Lee, Terry; Rey, Evelyne; Ross, Susan; Asztalos, Elizabeth; Murphy, Kellie E; Menzies, Jennifer; Sanchez, Johanna; Gafni, Amiram; Helewa, Michael; Hutton, Eileen; Koren, Gideon; Lee, Shoo K; Logan, Alexander G; Ganzevoort, Wessel; Welch, Ross; Thornton, Jim G; Moutquin, Jean-Marie

    2016-11-01

    To determine whether clinical outcomes differed by occurrence of severe hypertension in the international CHIPS trial (Control of Hypertension in Pregnancy Study), adjusting for the interventions of "less tight" (target diastolic blood pressure [dBP] 100 mm Hg) versus "tight" control (target dBP 85 mm Hg). In this post-hoc analysis of CHIPS data from 987 women with nonsevere nonproteinuric preexisting or gestational hypertension, mixed effects logistic regression was used to compare the following outcomes according to occurrence of severe hypertension, adjusting for allocated group and the influence of baseline factors: CHIPS primary (perinatal loss or high-level neonatal care for >48 hours) and secondary outcomes (serious maternal complications), birth weight <10th percentile, preeclampsia, delivery at <34 or <37 weeks, platelets <100×10(9)/L, elevated liver enzymes with symptoms, maternal length of stay ≥10 days, and maternal readmission before 6 weeks postpartum. Three hundred and thirty-four (34.1%) women in CHIPS developed severe hypertension that was associated with all outcomes examined except for maternal readmission (P=0.20): CHIPS primary outcome, birth weight <10th percentile, preeclampsia, preterm delivery, elevated liver enzymes (all P<0.001), platelets <100×10(9)/L (P=0.006), and prolonged hospital stay (P=0.03). The association between severe hypertension and serious maternal complications was seen only in less tight control (P=0.02). Adjustment for preeclampsia (464, 47.3%) did not negate the relationship between severe hypertension and the CHIPS primary outcome (P<0.001), birth weight <10th percentile (P=0.005), delivery at <37 (P<0.001) or <34 weeks (P<0.001), or elevated liver enzymes with symptoms (P=0.02). Severe hypertension is a risk marker for adverse maternal and perinatal outcomes, independent of BP control or preeclampsia co-occurrence.

  9. Rigorous anaesthesia management protocol for patients with intracranial arterial stenosis: a prospective controlled-cohort study

    PubMed Central

    Laiwalla, Azim N; Ooi, Yinn Cher; Van De Wiele, Barbara; Ziv, Keren; Brown, Adam; Liou, Raymond; Saver, Jeffrey L; Gonzalez, Nestor R

    2016-01-01

    Objectives Reducing variability is integral in quality management. As part of the ongoing Encephaloduroarteriosynangiosis Revascularisation for Symptomatic Intracranial Arterial Stenosis (ERSIAS) trial, we developed a strict anaesthesia protocol to minimise fluctuations in patient parameters affecting cerebral perfusion. We hypothesise that this protocol reduces the intraoperative variability of targeted monitored parameters compared to standard management. Design Prospective cohort study of patients undergoing encephaloduroarteriosynangiosis surgery versus standard neurovascular interventions. Patients with ERSIAS had strict perioperative management that included normocapnia and intentional hypertension. Control patients received regular anaesthetic standard of care. Minute-by-minute intraoperative vitals were electronically collected. Heterogeneity of variance tests were used to compare variance across groups. Mixed-model regression analysis was performed to establish the effects of treatment group on the monitored parameters. Setting Tertiary care centre. Participants 24 participants: 12 cases (53.8 years±16.7 years; 10 females) and 12 controls (51.3 years±15.2 years; 10 females). Adults aged 30–80 years, with transient ischaemic attack or non-disabling stroke (modified Rankin Scale <3) attributed to 70–99% intracranial stenosis of the carotid or middle cerebral artery, were considered for enrolment. Controls were matched according to age, gender and history of neurovascular intervention. Main outcome measures Variability of heart rate, mean arterial blood pressure (MAP), systolic blood pressure and end tidal CO2 (ETCO2) throughout surgical duration. Results There were significant reductions in the intraoperative MAP SD (4.26 vs 10.23 mm Hg; p=0.007) and ETCO2 SD (0.94 vs 1.26 mm Hg; p=0.05) between the ERSIAS and control groups. Median MAP and ETCO2 in the ERSIAS group were higher (98 mm Hg, IQR 23 vs 75 mm Hg, IQR 15; p<0

  10. Protocol for Studying Extinction of Conditioned Fear in Naturally Cycling Female Rats

    PubMed Central

    Maeng, Lisa Y.; Cover, Kara K.; Landau, Aaron J.; Milad, Mohammed R.; Lebron-Milad, Kelimer

    2015-01-01

    Extinction of conditioned fear has been extensively studied in male rodents. Recently, there have been an increasing number of studies indicating that neural mechanisms for certain behavioral tasks and response behaviors are different in females and males. Using females in research studies can represent a challenge because of the variation of gonadal hormones during their estrous cycle. This protocol describes well-established procedures that are useful in investigating the role of estrogen in fear extinction memory consolidation in female rats. Phase of the estrous cycle and exogenous estrogen administration prior to extinction training can influence extinction recall 24 hr later. The vaginal swabbing technique for estrous phase identification described here aids the examination and manipulation of naturally cycling gonadal hormones. The use of this basic rodent model may further delineate the mechanisms by which estrogen can modulate fear extinction memory in females. PMID:25741747

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

    PubMed Central

    Alanazi, Adwan; Elleithy, Khaled

    2015-01-01

    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. PMID:26364639

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

    PubMed

    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.

  13. [Therapeutic application of collateral ventilation in diffuse pulmonary emphysema: study protocol presentation].

    PubMed

    Saad, Roberto; Dorgan Neto, Vicente; Botter, Marcio; Stirbulov, Roberto; Rivaben, Jorge; Gonçalves, Roberto

    2008-06-01

    We present a protocol to test a new surgical procedure for the treatment of patients with diffuse lung emphysema who, after having received the golden standard treatment (pulmonary rehabilitation), continue to present respiratory failure with disabling dyspnea. Ten patients with severe lung hyperinflation will be evaluated. The method proposed is designed to create alternative expiratory passages for air trapped in the emphysematous lung by draining the lung parenchyma, thereby establishing communication between the alveoli and the external environment. The ten patients selected will be required to meet the inclusion criteria and to give written informed consent. Those ten patients will be included in the study pending the approval of the Ethics in Research Committee of the São Paulo Santa Casa School of Medicine, São Paulo, Brazil. The protocol we will employ in order to evaluate the proposed procedure is feasible and will show whether debilitated patients suffering from diffuse pulmonary emphysema can benefit from this procedure, which could represent an alternative to lung transplant or lung volume reduction surgery, the only options currently available.

  14. Multi-centred mixed-methods PEPFAR HIV care & support public health evaluation: study protocol

    PubMed Central

    2010-01-01

    Background A public health response is essential to meet the multidimensional needs of patients and families affected by HIV disease in sub-Saharan Africa. In order to appraise curret provision of HIV care and support in East Africa, and to provide evidence-based direction to future care programming, and Public Health Evaluation was commissioned by the PEPFAR programme of the US Government. Methods/Design This paper described the 2-Phase international mixed methods study protocol utilising longitudinal outcome measurement, surveys, patient and family qualitative interviews and focus groups, staff qualitative interviews, health economics and document analysis. Aim 1) To describe the nature and scope of HIV care and support in two African countries, including the types of facilities available, clients seen, and availability of specific components of care [Study Phase 1]. Aim 2) To determine patient health outcomes over time and principle cost drivers [Study Phase 2]. The study objectives are as follows. 1) To undertake a cross-sectional survey of service configuration and activity by sampling 10% of the facilities being funded by PEPFAR to provide HIV care and support in Kenya and Uganda (Phase 1) in order to describe care currently provided, including pharmacy drug reviews to determine availability and supply of essential drugs in HIV management. 2) To conduct patient focus group discussions at each of these (Phase 1) to determine care received. 3) To undertake a longitudinal prospective study of 1200 patients who are newly diagnosed with HIV or patients with HIV who present with a new problem attending PEPFAR care and support services. Data collection includes self-reported quality of life, core palliative outcomes and components of care received (Phase 2). 4) To conduct qualitative interviews with staff, patients and carers in order to explore and understand service issues and care provision in more depth (Phase 2). 5) To undertake document analysis to appraise

  15. The HALO submaximal treadmill protocol to measure cardiorespiratory fitness in obese children and youth: a proof of principle study.

    PubMed

    Breithaupt, Peter; Adamo, Kristi B; Colley, Rachel C

    2012-04-01

    Many limitations exist with completing cardiorespiratory fitness testing in obese children. The aim of this study was to determine if the new Healthy Active Living and Obesity Research Group's (HALO's) submaximal cardiorespiratory fitness testing protocol for obese children and youth provides a comparable estimate of peak oxygen uptake to that measured using validated maximal and submaximal, equation-based protocols in the obese pediatric population. A group of obese children (n = 21; all ≥95th body mass index percentile; aged 10-17 years) completed 3 exercise testing protocols. Testing was completed as part of an ongoing cohort study and 2 submaximal cardiorespiratory fitness tests were completed, in randomized order, during a second visit. Significant correlations were found between observed peak oxygen uptake (mL·min(-1)) and predicted peak oxygen uptake for both the HALO (r = 0.75, p = 0.001) and Nemeth (r = 0.66, p = 0.001) submaximal protocols. A similar correlation was found, after accounting for body mass, between measured and predicted HALO peak oxygen uptake (mL·kg(-1)·min(-1)) values (r = 0.54, p = 0.01). HALO predicted peak oxygen uptake values showed a significant correlation when plotted against the measured values (r = 0.99). A Bland-Altman analysis found agreement between the maximal and HALO submaximal protocols (mean bias = -201.75 mL·min(-1)). The significant relationships found between estimates of peak oxygen uptake from the HALO submaximal protocol and measures of peak oxygen uptake during maximal cardiorespiratory testing support the use of the HALO submaximal protocol as a valid measure to estimate maximal cardiorespiratory fitness within the obese pediatric population. Given the proof of principle goal of this study, future research in the obese, pediatric population is encouraged to confirm the generalizability of the protocol.

  16. The activity of French Research Ethics Committees and characteristics of biomedical research protocols involving humans: a retrospective cohort study

    PubMed Central

    Decullier, Evelyne; Lhéritier, Véronique; Chapuis, François

    2005-01-01

    Background Clinical trials throughout the world must be evaluated by research ethics committees. No one has yet attempted to clearly quantify at the national level the activity of ethics committees and describe the characteristics of the protocols submitted. The objectives of this study were to describe 1) the workload and the activity of Research Ethics Committees in France, and 2) the characteristics of protocols approved on a nation-wide basis. Methods Retrospective cohort of 976 protocols approved by a representative sample of 25/48 of French Research Ethics Committees in 1994. Protocols characteristics (design, study size, investigator), number of revisions requested by the ethics committee before approval, time to approval and number of amendments after approval were collected for each protocol by trained research assistant using the committee's files and archives. Results Thirty-one percent of protocols were approved with no modifications requested in 16 days (95% CI: 14–17). The number of revisions requested by the committee, and amendments submitted by the investigator was on average respectively 39 (95% CI: 25–53) and 37 (95% CI: 27–46), per committee and per year. When revisions were requested, the main reasons were related to information to the patient (28%) and consent modalities (18%). Drugs were the object of research in 68% of the protocols examined. The majority of the research was national (80%) with a predominance of single-centre studies. Workload per protocol has been estimated at twelve and half hours on average for administrative support and at eleven and half hours for expertise. Conclusion The estimated workload justifies specific and independent administrative and financial support for Research Ethics Committees. PMID:16229743

  17. Training and management of a multisite neuropsychological testing protocol for the Department of Veterans Affairs cooperative study evaluating on- and off-pump coronary artery bypass graft procedures.

    PubMed

    Kozora, E; Kongs, S; Box, T; Schooley, L; Hampton, M; Berkowitz, S; Grover, F; Shroyer, A L

    2007-07-01

    Research study coordinators from 17 sites participating in a cardiac surgery study were trained to administer and score a brief neuropsychological test battery. Results were sent to the study's centralized laboratory for review and feedback. The average examiner errors on the first six protocols were compared with the average errors on the last six protocols over 12 months for each site. Overall, errors for the first six protocols were 4.42, and errors for the last six protocols were 1.83, representing a significant overall decline. Errors for instruction, administration, and recording showed a significant decrease over time. Despite ongoing feedback to examiners, scoring errors did not decline significantly overall; this suggests that a review of all protocols is necessary to achieve reliable scoring. However, when examiners' number of protocols completed was compared with number of scoring errors per protocol, there was a trend for examiners who had completed more protocols to show more improvement in scoring.

  18. Enabling rapid behavioral ecotoxicity studies using an integrated lab-on-a-chip systems

    NASA Astrophysics Data System (ADS)

    Huang, Yushi; Nugegoda, Dayanthi; Wlodkowic, Donald

    2015-12-01

    Behavioral ecotoxicity tests are gaining an increasing recognition in environmental toxicology. Behavior of sensitive bioindicator species can change rapidly in response to an acute exposure to contaminants and thus has a much higher sensitivity as compared to conventional LC50 mortality tests. Furthermore, behavioral endpoints seems to be very good candidates to develop early-warning biomonitoring systems needed for rapid chemical risk assessment. Behavioral tests are non-invasive, fast, do not harm indicator organisms (behavioural changes are very rapid) and are thus fully compatible with 3R (Replacement - Reduction - Refinement) principle encouraging alternatives to conventional animal testing. These characteristics are essential when designing improved ecotoxicity tests for chemical risk assessment. In this work, we present a pilot development of miniaturized Lab-on-a-Chip (LOC) devices for studying toxin avoidance behaviors of small aquatic crustaceans. As an investigative tool, LOCs represent a new direction that may miniaturize and revolutionize behavioral ecotoxicology. Specifically our innovative microfluidic prototype: (i) enables convening "caging" of specimens for real-time videomicroscopy; (ii) eliminates the evaporative water loss thus providing an opportunity for long-term behavioral studies; (iii) exploits laminar fluid flow under low Reynolds numbers to generate discrete domains and gradients enabling for the first time toxin avoidance studies on small aquatic crustaceans; (iv) integrates off-the-chip mechatronic interfaces and video analysis algorithms for single animal movement analysis. We provide evidence that by merging innovative bioelectronic and biomicrofluidic technologies we can deploy inexpensive and reliable systems for culture, electronic tracking and complex computational analysis of behavior of bioindicator organisms.

  19. Cardiac mitochondrial membrane stability after deep hypothermia using a xenon clathrate cryostasis protocol - an electron microscopy study.

    PubMed

    Sheleg, Sergey; Hixon, Hugh; Cohen, Bruce; Lowry, David; Nedzved, Mikhail

    2008-01-01

    We investigated a new cryopreservation method using xenon, a clathrate-forming gas, under medium pressure (100psi). The objective of the study was to determine whether this cryostasis protocol could protect cardiac mitochondria at cryogenic temperatures (below 100 degrees Celsius).We analyzed transmission electron microscopy images to obtain information about changes in mitochondrial morphology induced by cryopreservation of the hearts. Our data showed absence of mitochondrial swelling, rupture of inner and outer membranes, and leakage of mitochondrial matrix into the cytoplasm after applying this cryostasis protocol. The electron microscopy results provided the first evidence that a cryostasis protocol using xenon as a clathrate-forming gas under pressure may have protective effects on intracellular membranes. This cryostasis technology may find applications in developing new approaches for long-term cryopreservation protocols.

  20. A rapid and hazardous reagent free protocol for genomic DNA extraction suitable for genetic studies in plants.

    PubMed

    Kotchoni, Simeon O; Gachomo, Emma W

    2009-07-01

    Protocols for genomic DNA extraction from plants are generally lengthy, since they require that tissues be ground in liquid nitrogen, followed by a precipitation step, washing and drying of the DNA pellet, etc. This represents a major challenge especially when several hundred samples must be screened/analyzed within a working day. There is therefore a need for a rapid and simple procedure, which will produce DNA quality suitable for various analyses. Here, we describe a time and cost efficient protocol for genomic DNA isolation from plants suitable for all routine genetic screening/analyses. The protocol is free from hazardous reagents and therefore safe to be executed by non-specialists. With this protocol more than 100 genomic DNA samples could manually be extracted within a working day, making it a promising alternative in genetic studies of large-scale genomic screening projects.

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

    PubMed Central

    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

  2. All polymer chip for amperometric studies of transmitter release from large groups of neuronal cells.

    PubMed

    Larsen, Simon T; Taboryski, Rafael

    2012-11-07

    We present an all polymer electrochemical chip for simple detection of transmitter release from large groups of cultured PC 12 cells. Conductive polymer PEDOT:tosylate microelectrodes were used together with constant potential amperometry to obtain easy-to-analyze oxidation signals from potassium-induced release of transmitter molecules. The nature of the resulting current peaks is discussed, and the time for restoring transmitter reservoirs is studied. The relationship between released transmitters and potassium concentration was found to fit to a sigmoidal dose-response curve. Finally, we demonstrate how the presented device can be used for simple drug screening purposes, by measuring the increase of transmitter release due to short-term treatment with L-DOPA.

  3. A Pilot Study for Applying an Extravehicular Activity Exercise Prebreathe Protocol to the International Space Station

    NASA Technical Reports Server (NTRS)

    Woodruff, Kristin K.; Johnson, Anyika N.; Lee, Stuart M. C.; Gernhardt, Michael; Schneider, Suzanne M.; Foster, Philip P.

    2000-01-01

    Decompression sickness (DCS) is a serious risk to astronauts performing extravehicular activity (EVA). To reduce this risk, the addition of ten minutes of moderate exercise (75% VO2pk) during prebreathe has been shown to decrease the total prebreathe time from 4 to 2 hours and to decrease the incidence of DCS. The overall purpose of this pilot study was to develop an exercise protocol using flight hardware and an in-flight physical fitness cycle test to perform prebreathe exercise before an EVA. Eleven subjects volunteered to participate in this study. The first objective of this study was to compare the steady-state heart rate (HR) and oxygen consumption (VO2) from a submaximal arm and leg exercise (ALE) session with those predicted from a maximal ALE test. The second objective was to compare the steady-state HR and V02 from a submaximal elastic tube and leg exercise (TLE) session with those predicted from the maximal ALE test. The third objective involved a comparison of the maximal ALE test with a maximal leg-only (LE) test to conform to the in- flight fitness assessment test. The 75% VO2pk target HR from the LE test was significantly less than the target HR from the ALE test. Prescribing exercise using data from the maximal ALE test resulted in the measured submaximal values being higher than predicted VO2 and HR. The results of this pilot study suggest that elastic tubing is valid during EVA prebreathe as a method of arm exercise with the flight leg ergometer and it is recommended that prebreathe countermeasure exercise protocol incorporate this method.

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

    PubMed Central

    Shattuck, Dominick C; Jennings, Victoria H

    2017-01-01

    course of 13 menstrual cycles to 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. Results 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. Conclusions 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. ClinicalTrial ClinicalTrials.gov NCT02833922; https://clinicaltrials.gov/ct2/show/NCT02833922 (Archived be WebCite at http://www.webcitation.org/6nDkr0e76) PMID:28100441

  5. Modeling of un-deformed chip thickness in RUM process and study of size effects in μ-RUM.

    PubMed

    Jain, Anil Kumar; Pandey, Pulak M

    2017-05-01

    Un-deformed chip thickness is a critical parameter in machining processes. Measuring un-deformed chip thickness experimentally is a complicated process, especially in micro machining and may not even be measured accurately. The un-deformed chip thickness has an influence on material removal rate, cutting forces, specific energy and surface finish etc. In ceramic machining, it is also an indication of material removal mode such as ductile or brittle fracture. In the present study, an effort is made to model undeformed chip thickness, cutting forces and specific cutting energy in rotary ultrasonic machining (RUM) applied to the side milling operation. RUM may be considered as super-imposition of ultrasonic vibrations on the grinding process. The kinematics of ultrasonic motion has been applied to the grinding for the development of the RUM process models. To validate the models, machining experiments have been performed on borosilicate glass in RUM and grinding modes. Percentage of ductile mode of fracture for the machined surfaces has been evaluated using SEM images. Surface roughness values have also been compared for the same material removal rate conditions to ascertain fracture mode. Developed models have been verified and found that ductile mode of fracture as well as surface finish were higher in RUM as compared to grinding process for same material removal rate. RUM process for six aerospace grade materials has also been tried using micro and macro tools and size effects studied.

  6. Single-copy gene based 50 K SNP chip for genetic studies and molecular breeding in rice

    PubMed Central

    Singh, Nisha; Jayaswal, Pawan Kumar; Panda, Kabita; Mandal, Paritra; Kumar, Vinod; Singh, Balwant; Mishra, Shefali; Singh, Yashi; Singh, Renu; Rai, Vandna; Gupta, Anita; Raj Sharma, Tilak; Singh, Nagendra Kumar

    2015-01-01

    Single nucleotide polymorphism (SNP) is the most abundant DNA sequence variation present in plant genomes. Here, we report the design and validation of a unique genic-SNP genotyping chip for genetic and evolutionary studies as well as molecular breeding applications in rice. The chip incorporates 50,051 SNPs from 18,980 different genes spanning 12 rice chromosomes, including 3,710 single-copy (SC) genes conserved between wheat and rice, 14,959 SC genes unique to rice, 194 agronomically important cloned rice genes and 117 multi-copy rice genes. Assays with this chip showed high success rate and reproducibility because of the SC gene based array with no sequence redundancy and cross-hybridisation problems. The usefulness of the chip in genetic diversity and phylogenetic studies of cultivated and wild rice germplasm was demonstrated. Furthermore, its efficacy was validated for analysing background recovery in improved mega rice varieties with submergence tolerance developed through marker-assisted backcross breeding. PMID:26111882

  7. An on-chip small intestine-liver model for pharmacokinetic studies.

    PubMed

    Kimura, Hiroshi; Ikeda, Takashi; Nakayama, Hidenari; Sakai, Yasuyuki; Fujii, Teruo

    2015-06-01

    Testing of drug effects and cytotoxicity by using cultured cells has been widely performed as an alternative to animal testing. However, the estimation of pharmacokinetics by conventional cell-based assay methods is difficult because of the inability to evaluate multiorgan effects. An important challenge in the field is to mimic the organ-to-organ network in the human body by using a microfluidic network connecting small-scale tissues based on recently emerging MicroTAS (Micro Total Analysis Systems) technology for prediction of pharmacokinetics. Here, we describe an on-chip small intestine-liver coupled model for pharmacokinetic studies. To construct an in vitro pharmacokinetic model that appropriately models in vivo conditions, physiological parameters such as the structure of internal circulation, volume ratios of each organ, and blood flow ratio of the portal vein to the hepatic artery were mimicked using microfluidic networks. To demonstrate interactions between organs in vitro in pharmacokinetic studies, Caco-2, HepG2, and A549 cell cultures were used as organ models of the small intestine, liver, and lung, respectively, and connected to each other through a microporous membrane and microchannels to prepare a simple model of a physiological organ-to-organ network. The on-chip organ model assay using three types of substrate-epirubicine (EPI), irinotecan (CPT-11), and cyclophosphamide (CPA)-were conducted to model the effects of orally administered or biologically active anticancer drugs. The result suggested that the device can replicate physiological phenomena such as activity of the anticancer drugs on the target cells. This microfluidic device can thus be used as an in vitro organ model to predict the pharmacokinetics of drugs in the human body and may thus provide not only an alternative to animal testing but also a method of obtaining parameters for in silico models of physiologically based pharmacokinetics.

  8. Balancing nurses' workload in hospital wards: study protocol of developing a method to manage workload

    PubMed Central

    van den Oetelaar, W F J M; van Stel, H F; van Rhenen, W; Stellato, R K; Grolman, W

    2016-01-01

    Introduction Hospitals pursue different goals at the same time: excellent service to their patients, good quality care, operational excellence, retaining employees. This requires a good balance between patient needs and nursing staff. One way to ensure a proper fit between patient needs and nursing staff is to work with a workload management method. In our view, a nursing workload management method needs to have the following characteristics: easy to interpret; limited additional registration; applicable to different types of hospital wards; supported by nurses; covers all activities of nurses and suitable for prospective planning of nursing staff. At present, no such method is available. Methods/analysis The research follows several steps to come to a workload management method for staff nurses. First, a list of patient characteristics relevant to care time will be composed by performing a Delphi study among staff nurses. Next, a time study of nurses’ activities will be carried out. The 2 can be combined to estimate care time per patient group and estimate the time nurses spend on non-patient-related activities. These 2 estimates can be combined and compared with available nursing resources: this gives an estimate of nurses’ workload. The research will take place in an academic hospital in the Netherlands. 6 surgical wards will be included, capacity 15–30 beds. Ethical considerations The study protocol was submitted to the Medical Ethical Review Board of the University Medical Center (UMC) Utrecht and received a positive advice, protocol number 14-165/C. Discussion This method will be developed in close cooperation with staff nurses and ward management. The strong involvement of the end users will contribute to a broader support of the results. The method we will develop may also be useful for planning purposes; this is a strong advantage compared with existing methods, which tend to focus on retrospective analysis. PMID:28186931

  9. National validation study of a swab protocol for the recovery of Bacillus anthracis spores from surfaces.

    PubMed

    Hodges, Lisa R; Rose, Laura J; O'Connell, Heather; Arduino, Matthew J

    2010-05-01

    Twelve Laboratory Response Network (LRN) affiliated laboratories participated in a validation study of a macrofoam swab protocol for the recovery, detection, and quantification of viable B. anthracis (BA) Sterne spores from steel surfaces. CDC personnel inoculated steel coupons (26cm(2)) with 1-4 log(10) BA spores and recovered them by sampling with pre-moistened macrofoam swabs. Phase 1 (P1) of the study evaluated swabs containing BA only, while dust and background organisms were added to swabs in Phase 2 (P2) to mimic environmental conditions. Laboratories processed swabs and enumerated spores by culturing eluted swab suspensions and counting colonies with morphology consistent with BA. Processed swabs were placed in enrichment broth, incubated 24h, and cultured by streaking for isolation. Real-time PCR was performed on selected colonies from P2 samples to confirm the identity of BA. Mean percent recovery (%R) of spores from the surface ranged from 15.8 to 31.0% (P1) and from 27.9 to 55.0% (P2). The highest mean percent recovery was 31.0% (sd 10.9%) for P1 (4 log(10) inoculum) and 55.0% (sd 27.6%) for P2 (1 log(10) inoculum). The overall %R was higher for P2 (44.6%) than P1 (24.1%), but the overall reproducibility (between-lab variability) was lower in P2 than in P1 (25.0 vs 16.5%CV, respectively). The overall precision (within-lab variability) was close to identical for P1 and P2 (44.0 and 44.1, respectively), but varied greatly between inoculum levels. The protocol demonstrated linearity in %R over the three inoculum levels and is able to detect between 26 and 5x10(6)spores/26cm(2). Sensitivity as determined by culture was >98.3% for both phases and all inocula, suggesting that the culture method maintains sensitivity in the presence of contaminants. The enrichment broth method alone was less sensitive for sampled swabs (66.4%) during P2, suggesting that the presence of background organisms inhibited growth or isolation of BA from the broth. The addition of

  10. A Randomized Controlled Study to Compare Conventional and Evidence Based Treatment Protocols in Fresh Compound Fractures

    PubMed Central

    Mahajan, Kanika; Singh, Girish Kumar; Kumar, Santosh; Avasthi, Sachin

    2016-01-01

    Introduction A recent concept review in Journal of Bone and Joint Surgery (JBJS) outlines evidence to control peri-operative infections in compound fractures. However, evidence for impact of adopting a protocol combining measures that have some evidence is lacking in literature. The present method of treatment at King George’s Medical University (KGMU) is representative of the conventional practice of managing compound fractures in India and is an appropriate control for trial against the Experimental Evidence Based Protocol (EBP). Aim To study the additional impact of adopting Evidence Based Protocol on parameters defining infection rate and bone union. Materials and Methods This randomized controlled study was conducted at the orthopaedics department of KGMU. Two hundred and twenty six patients of compound fractures of both bone leg, age > 12y were randomized to two groups. One group received standard treatment and the experimental group received treatment as per JBJS review. Statistical Analysis Random allocation was tested by comparing baseline characteristics of the two groups. The two groups were compared for all the outcome variables in terms of time to a negative wound culture, time to wound healing, time to union at fracture site and time to achieve complete range of motion at knee joint. Results Random allocation was successful. EBP group reported significantly lesser time to a negative culture report from wound (mean in conventional=4.619, experimental=1.9146, p=0.0006), lesser time to bony union (mean in conventional=23.8427 weeks, experimental=22.8125 weeks, p=0.0027), lesser time to wound healing (mean in conventional=14.4425 weeks experimental=10.4513 weeks, p=0.0032), and a lesser duration of hospital stay (mean in conventional=6.5982 days, experimental=4.5000 days, p=0.0343). Conclusion EBP based on the guidelines suggested by Fletcher et al., significantly shorten the time taken for achieving a negative culture and hasten wound and fracture

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

    PubMed Central

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

    2016-01-01

    Background 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. Objective Develop three protocols to support tablet configuration, tablet management, and tablet maintenance. Methods 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. Results This article provides three protocols: the Configurator protocol, the Tile protocol, and the infection control protocol. Conclusions 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. PMID:27350013

  12. Burnout among chiropractic practitioners: real or imagined an exploratory study protocol

    PubMed Central

    2012-01-01

    Burnout is a psychological syndrome of emotional exhaustion, depersonalization and reduced personal accomplishment that has been found to exist in a significant number of healthcare and helping professionals. It imposes a significant societal burden by shortened practitioner lifespan, decreased efficiency, negative health outcomes and poorer levels of patient care. Theoretical models suggest that it appears to be the result of a complex interaction between job resources and job demands. It may be reasonable to conclude that Chiropractic professionals experience similar vocational demands and thus experience significant levels of occupational stress and subsequent burnout. However the data on burnout within the chiropractic profession is limited. It is possible that this results in significant negative outcomes on chiropractors and their patients. Therefore, the objective of this paper is to demonstrate the need to explore burnout in chiropractic practice and offer a research protocol for a potential study. PMID:22369737

  13. Income Eligibility Thresholds, Premium Contributions, and Children's Coverage Outcomes: A Study of CHIP Expansions

    PubMed Central

    Gresenz, Carole Roan; Edgington, Sarah E; Laugesen, Miriam J; Escarce, José J

    2013-01-01

    Objective To understand the effects of Children's Health Insurance Program (CHIP) income eligibility thresholds and premium contribution requirements on health insurance coverage outcomes among children. Data Sources 2002–2009 Annual Social and Economic Supplements of the Current Population Survey linked to data from multiple secondary data sources. Study Design We use a selection correction model to simultaneously estimate program eligibility and coverage outcomes conditional upon eligibility. We simulate the effects of three premium schedules representing a range of generosity levels and the effects of income eligibility thresholds ranging from 200 to 400 percent of the federal poverty line. Principal Findings Premium contribution requirements decrease enrollment in public coverage and increase enrollment in private coverage, with larger effects for greater contribution levels. Our simulation results suggest minimal changes in coverage outcomes from eligibility expansions to higher income families under premium schedules that require more than a modest contribution (medium or high schedules). Conclusions Our simulation results are useful counterpoints to previous research that has estimated the average effect of program expansions as they were implemented without disentangling the effects of premiums or other program features. The sensitivity to premiums observed suggests that although contribution requirements may be effective in reducing crowd-out, they also have the potential, depending on the level of contribution required, to nullify the effects of CHIP expansions entirely. The persistence of uninsurance among children under the range of simulated scenarios points to the importance of Affordable Care Act provisions designed to make the process of obtaining coverage transparent and navigable. PMID:23398477

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

    PubMed Central

    2009-01-01

    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 PMID:20025727

  15. Chip-on-Board Technology 1996 Year-end Report (Design, Manufacturing, and Reliability Study)

    NASA Technical Reports Server (NTRS)

    Le, Binh Q.; Nhan, Elbert; Maurer, Richard H.; Lew, Ark L.; Lander, Juan R.

    1996-01-01

    The major impetus for flight qualifying Chip-On-Board (COB) packaging technology is the shift in emphasis for space missions to smaller, better, and cheaper spacecraft and satellites resulting from the NASA New Millenium initiative and similar requirements in DoD-sponsored programs. The most important benefit that can potentially be derived from miniaturizing spacecraft and satellites is the significant cost saving realizable if a smaller launch vehicle may be employed. Besides the program cost saving, there are several other advantages to building COB-based space hardware. First, once a well-controlled process is established, COB can be low cost compared to standard Multi-Chip Module (MCM) technology. This cost competitiveness is regarded as a result of the generally greater availability and lower cost of Known Good Die (KGD). Coupled with the elimination of the first level of packaging (chip package), compact, high-density circuit boards can be realized with Printed Wiring Boards (PWB) that can now be made with ever-decreasing feature size in line width and via hole. Since the COB packaging technique in this study is based mainly on populating bare dice on a suitable multi-layer laminate substrate which is not hermetically sealed, die coating for protection from the environment is required. In recent years, significant improvements have been made in die coating materials which further enhance the appeal of COB. Hysol epoxies, silicone, parylene and silicon nitride are desirable because of their compatible Thermal Coefficient of Expansion (TCE) and good moisture resistant capability. These die coating materials have all been used in the space and other industries with varying degrees of success. COB technology, specifically siliconnitride coated hardware, has been flown by Lockheed on the Polar satellite. In addition, DARPA has invested a substantial amount of resources on MCM and COB-related activities recently. With COB on the verge of becoming a dominant player

  16. Towards the genetic basis of cerebral venous thrombosis—the BEAST Consortium: a study protocol

    PubMed Central

    Cotlarciuc, Ioana; Marjot, Thomas; Khan, Muhammad S; Hiltunen, Sini; Haapaniemi, Elena; Metso, Tiina M; Putaala, Jukka; Zuurbier, Susanna M; Brouwer, Matthijs C; Passamonti, Serena M; Bucciarelli, Paolo; Pappalardo, Emanuela; Patel, Tasmin; Costa, Paolo; Colombi, Marina; Canhão, Patrícia; Tkach, Aleksander; Santacroce, Rosa; Margaglione, Maurizio; Favuzzi, Giovanni; Grandone, Elvira; Colaizzo, Donatella; Spengos, Kostas; Arauz, Antonio; Hodge, Amanda; Ditta, Reina; Debette, Stephanie; Zedde, Marialuisa; Pare, Guillaume; Ferro, José M; Thijs, Vincent; Pezzini, Alessandro; Majersik, Jennifer J; Martinelli, Ida; Coutinho, Jonathan M; Tatlisumak, Turgut; Sharma, Pankaj

    2016-01-01

    Introduction Cerebral venous thrombosis (CVT) is a rare cerebrovascular condition accounting for <1% of all stroke cases and mainly affects young adults. Its genetic aetiology is not clearly elucidated. Methods and analysis To better understand the genetic basis of CVT, we have established an international biobank of CVT cases, Biorepository to Establish the Aetiology of Sinovenous Thrombosis (BEAST) which aims to recruit highly phenotyped cases initially of European descent and later from other populations. To date we have recruited 745 CVT cases from 12 research centres. As an initial step, the consortium plans to undertake a genome-wide association analysis of CVT using the Illumina Infinium HumanCoreExome BeadChip to assess the association and impact of common and low-frequency genetic variants on CVT risk by using a case–control study design. Replication will be performed to confirm putative findings. Furthermore, we aim to identify interactions of genetic variants with several environmental and comorbidity factors which will likely contribute to improve the understanding of the biological mechanisms underlying this complex disease. Ethics and dissemination BEAST meets all ethical standards set by local institutional review boards for each of the participating sites. The research outcomes will be published in international peer-reviewed open-access journals with high impact and visibility. The results will be presented at national and international meetings to highlight the contributions into improving the understanding of the mechanisms underlying this uncommon but important disease. This international DNA repository will become an important resource for investigators in the field of haematological and vascular disorders. PMID:27881526

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

    PubMed Central

    Sung, Young-Hye; Kim, Hae-Young; Son, Ho-Hyun

    2014-01-01

    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. PMID:25110639

  18. Expert viewing protocol performance study: the case of subjective evaluation of HDR coding

    NASA Astrophysics Data System (ADS)

    Baroncini, Vittorio; Baroncini, Giacomo; Topiwala, Pankaj

    2016-09-01

    This paper tries to examine the results of a subjective evaluation experiment, made by means of the new Expert Viewing Protocol, recently approved by ITU-R Study Group 6 [1]. The EVP subjective test was designed and performed to compare different HDR coding technologies during an MPEG meeting (San Diego, CA, February 2016) [2]. Thanks to the wide and enthusiastic participation of the MPEG experts to the subjective evaluation experiment, it was possible to collect data from a total of sixteen viewers; this allowed to perform a sort of "validation" of the performance of the EVP. The ITU-R Recommendation states that tests with nine viewers is sufficient to get acceptable results from an EVP experiment. In our case, having data from 16 viewers, it was possible to compute the MOS and the Confidence Interval data as if it were a standard subjective assessment experiment (which typically requires more viewers). This allowed a sort of "validation" of the results obtained using results from 9 experts only vs. the results obtained using the data from the 16 viewers. The analysis of the raw data showed a rather good conversion of the EVP results towards the results obtained using the full viewers' data set. The results of the EVP evaluation of MPEG HDR content was described in details in a previous paper [3], to which we defer for details on the EVP protocol procedure and rules. This paper instead tries to answer to a demand for further clarification on the "context" and "limitations of use" of the EVP when performed in alternative to a formal subjective experiment trial.

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

    PubMed Central

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

    2016-01-01

    Objective 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. Design, setting and participants 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. Results 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. Conclusions 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. PMID:26916691

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

    PubMed Central

    2011-01-01

    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 matter in the transition

  1. Comprehensive Study of Microgel Electrode for On-Chip Electrophoretic Cell Sorting

    NASA Astrophysics Data System (ADS)

    Hattori, Akihiro; Yasuda, Kenji

    2010-06-01

    We have developed an on-chip cell sorting system and microgel electrode for applying electrostatic force in microfluidic pathways in the chip. The advantages of agarose electrodes are 1) current-driven electrostatic force generation, 2) stability against pH change and chemicals, and 3) no bubble formation caused by electrolysis. We examined the carrier ion type and concentration dependence of microgel electrode impedance, and found that CoCl2 has less than 1/10 of the impedance from NaCl, and the reduction of the impedance of NaCl gel electrode was plateaued at 0.5 M. The structure control of the microgel electrode exploiting the surface tension of sol-state agarose was also introduced. The addition of 1% (w/v) trehalose into the microgel electrode allowed the frozen storage of the microgel electrode chip. The experimental results demonstrate the potential of our system and microgel electrode for practical applications in microfluidic chips.

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

    PubMed Central

    2009-01-01

    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. PMID:19912627

  3. Protocol for study of financial incentives for smoking cessation in pregnancy (FISCP): randomised, multicentre study

    PubMed Central

    Berlin, Noémi; Goldzahl, Léontine; Jusot, Florence; Berlin, Ivan

    2016-01-01

    Introduction Maternal smoking during pregnancy is associated with adverse perinatal and postnatal health outcomes. The efficacy of nicotine replacement therapies in helping pregnant smokers to quit is not clearly demonstrated; therefore new interventions should be proposed and assessed. Financial incentives rewarding abstinence from tobacco smoking is one of the promising options. Objective To assess the efficacy of financial incentives on smoking abstinence among French pregnant smokers. Methods and analysis Participants: pregnant smokers aged ≥18 years, smoking at least five manufactured or three roll-your-own cigarettes per day, and pregnant for <18 weeks of amenorrhoea (WA). Setting: participants will be recruited, included and followed-up at monthly face-to-face visits in 16 maternity wards in France. Interventions: participants will be randomised to a control or an intervention group. After a predefined quit date, participants in the control group will receive €20 vouchers at the completion of each visit but no financial incentive for smoking abstinence. Participants in the intervention group will be rewarded for their abstinence by vouchers on top of the €20 show-up fee. The amount of reward for abstinence will increase as a function of duration of abstinence to stimulate longer periods of abstinence. Main outcome measure: complete abstinence from quit date to the last predelivery visit. Secondary outcome measures: point prevalence abstinence, time to relapse to smoking, birth weight, fetal growth restriction, preterm birth. Main data analysis: outcomes will be analysed on an intention-to-treat (ITT) basis. The ITT population is defined as all randomised smoking pregnant women. Ethics and dissemination The research protocol was approved by the ethics committee (Comité de Protection des Personnes, CPP) of the Pitié-Salpêtrière Hospital on 15 May 2015, and Amendment No 1 was approved on 13 July 2015. Results will be presented at scientific

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

    PubMed Central

    2011-01-01

    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 at 4 month follow-up to

  5. Histomorphometric assessment of bone necrosis produced by two cryosurgery protocols using liquid nitrogen: an experimental study on rat femurs

    PubMed Central

    COSTA, Fábio Wildson Gurgel; BRITO, Gerly Anne de Castro; PESSOA, Rosana Maria Andrade; STUDART-SOARES, Eduardo Costa

    2011-01-01

    Objective The aim of this study was to evaluate the effects of liquid nitrogen cryosurgery on the femoral diaphysis of rats. Material and Methods The femoral diaphyses of 42 Wistar rats were exposed to three local and sequential applications of liquid nitrogen for 1 or 2 min, intercalated with periods of 5 min of passive thawing. The animals were sacrificed after 1, 2, 4 and 12 weeks and the specimens obtained were processed and analyzed histomorphometrically. Results The depth and extent of peak bone necrosis were 124.509 μm and 2087.094 μm for the 1-min protocol, respectively, and 436.424 μm and 12046.426 μm for the 2-min protocol. Peak necrosis was observed in the second experimental week with both cryotherapy protocols. Conclusions The present results indicate that the 2-min protocol produced more marked bone necrosis than the 1-min protocol. Although our results cannot be entirely extrapolated to clinical practice, they contribute to the understanding of the behavior of bone tissue submitted to different cycles of liquid nitrogen freezing and may serve as a basis for new studies. PMID:22230994

  6. Developing psychotherapists’ competence through clinical supervision: protocol for a qualitative study of supervisory dyads

    PubMed Central

    2013-01-01

    Background Mental health professionals face unique demands and stressors in their work, resulting in high rates of burnout and distress. Clinical supervision is a widely adopted and valued mechanism of professional support, development, and accountability, despite the very limited evidence of specific impacts on therapist or client outcomes. The current study aims to address this by exploring how psychotherapists develop competence through clinical supervision and what impact this has on the supervisees’ practice and their clients’ outcomes. This paper provides a rationale for the study and describes the protocol for an in-depth qualitative study of supervisory dyads, highlighting how it addresses gaps in the literature. Methods/Design The study of 16–20 supervisor-supervisee dyads uses a qualitative mixed method design, with two phases. In phase one, supervisors who are nominated as expert by their peers are interviewed about their supervision practice. In phase two, supervisors record a supervision session with a consenting supervisee; interpersonal process recall interviews are conducted separately with supervisor and supervisee to reflect in depth on the teaching and learning processes occurring. All interviews will be transcribed, coded and analysed to identify the processes that build competence, using a modified form of Consensual Qualitative Research (CQR) strategies. Using a theory-building case study method, data from both phases of the study will be integrated to develop a model describing the processes that build competence and support wellbeing in practising psychotherapists, reflecting the accumulated wisdom of the expert supervisors. Discussion The study addresses past study limitations by examining expert supervisors and their supervisory interactions, by reflecting on actual supervision sessions, and by using dyadic analysis of the supervisory pairs. The study findings will inform the development of future supervision training and practice

  7. Efficacy of intravenous nicorandil for fractional flow reserve assessment: study protocol for a crossover randomised trial

    PubMed Central

    Nishi, Takeshi; Kitahara, Hideki; Fujimoto, Yoshihide; Nakayama, Takashi; Sugimoto, Kazumasa; Hanaoka, Hideki; Kobayashi, Yoshio

    2016-01-01

    Introduction Nicorandil has vasodilatory effects on both the epicardial coronary arteries and the coronary microvasculature, thereby increasing coronary blood flow. Intravenous administration of nicorandil can be applicable for fractional flow reserve (FFR) measurement as a hyperaemic agent and a possible alternative to adenosine. However, the effectiveness of intravenous nicorandil infusion for FFR measurement is largely unclear. Methods and analysis This crossover randomised study is being performed to investigate the efficacy of intravenous administration of nicorandil for FFR measurement. Patients with an intermediate coronary artery stenosis who satisfy the eligibility criteria undergo FFR measurement with a consecutive randomised order of patient-blind infusions of continuous intravenous administration of adenosine and a single bolus intravenous administration of nicorandil. The primary end point of the study is the agreement between the FFR values obtained by the intravenous nicorandil and those obtained by the intravenous adenosine. Recruitment of this trial started in November 2015 and will end in March 2017, or until a total of 50 participants have been recruited. Ethics and dissemination The protocol was approved by the Institutional Review Board at Chiba University Hospital. Study findings will be published in peer-reviewed journals. Trial registration number UMIN000019309; Pre-results. PMID:27872119

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

    PubMed Central

    Wartha, Olivia; Dreyhaupt, Jens; Lämmle, Christine; Friedemann, Eva-Maria; Kelso, Anne; Kutzner, Claire; Hermeling, Lina

    2017-01-01

    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. PMID:28303253

  9. Cardiovascular Risk and Its Associated Factors in Health Care Workers in Colombia: A Study Protocol

    PubMed Central

    2015-01-01

    Background Cardiovascular diseases are the leading cause of mortality worldwide, for this reason, they are a public health problem. In Colombia, cardiovascular diseases are the main cause of mortality, having a death rate of 152 deaths per 100,000 population. There are 80% of these cardiovascular events that are considered avoidable. Objective The objective of the study is to determine the prevalence of the cardiovascular risk and its associated factors among the institution’s workers in order to design and implement interventions in the work environment which may achieve a decrease in such risk. Methods An analytical cross-sectional study was designed to determine the cardiovascular risk and its associated factors among workers of a high complexity health care institution. A self-applied survey will be conducted considering sociodemographic aspects, physical activity, diet, alcohol consumption, smoking, level of perceived stress, and personal and family history. In a second appointment, a physical examination will be made, as well as anthropometric measurements and blood pressure determination. Also, blood samples for evaluating total and high density lipoprotein cholesterol, triglycerides, and fasting blood sugar will be taken. A ten-year global risk for cardiovascular disease will be determined using the Framingham score. A descriptive analysis of the population’s characteristics and a stratified analysis by sex, age, and occupation will be made. Bivariate and multivariate analysis will be made using logistic regression models to evaluate the association between cardiovascular risk and the independent variables. The research protocol was approved by the Scientific and Technical Committee and the Ethics Committee on Research of the Fundación Cardiovascular de Colombia. Results The protocol has already received funding and the enrollment phase will begin in the coming months. Conclusions The results of this study will give the foundation for the design

  10. Using Computer-Generated Protocols to Study Writers’ Planning Strategies

    DTIC Science & Technology

    1990-09-01

    has shown that extensive planning is typical of skilled adult writers.(.Bridwell-Bowles, Johnson; & Brehe, 1987; Flower & Hayes, 1981b). Yet word...planning processes, they have used think-aloud protocols, generated when writers verbalize their thoughts as they compose (Swarts, Flower & Hayes, 1984). On...the basis of think-aloud protocols, Flower and Hayes (1981b) have argued that planrdng is central to adult writing. They have defined a broad variety

  11. Comparison of the ultrashort gonadotropin-releasing hormone agonist-antagonist protocol with microdose flare -up protocol in poor responders: a preliminary study

    PubMed Central

    Berker, Bülent; Duvan, Candan İltemir; Kaya, Cemil; Aytaç, Ruşen; Şatıroğlu, Hakan

    2010-01-01

    Objective To determine the potential effect of the ultrashort gonadotropin-releasing hormone (GnRH) agonist/GnRH antagonist protocol versus the microdose GnRH agonist protocol in poor responders undergoing intracytoplasmic sperm injection (ICSI). Material and Methods The patients in the Agonist-Antagonist Group (n=41) were administered the ultrashort GnRH-agonist/ antagonist protocol, while the patients in the Microdose Group (n=41) were stimulated according to the microdose flare-up protocol. The mean number of mature oocytes retrieved was the primary outcome measure. Fertilization rate, implantation rate per embryo and clinical pregnancy rates were secondary outcome measures. Results There was no differenc between the mean number of mature oocytes retrieved in the two groups. There were also no statistical differences between the two groups in terms of peak serum E2 level, canceled cycles, endometrial thickness on hCG day, number of 2 pronucleus and number of embryos transferred. However, the total gonadotropin consumption and duration of stimulation were significantly higher with the Agonist-Antagonist Group compared with the Microdose Group. The implantation and clinical pregnancy rates were similar between the two groups. Conclusion Despite the high dose of gonadotropin consumption and longer duration of stimulation with the ultrashort GnRH agonist/ antagonist protocol, it seems that the Agonist-Antagonist Protocol is not inferior to the microdose protocol in poor responders undergoing ICSI. PMID:24591934

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

    PubMed

    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.

  13. Performance of research ethics committees in Spain. A prospective study of 100 applications for clinical trial protocols on medicines.

    PubMed Central

    Dal-Ré, R; Espada, J; Ortega, R

    1999-01-01

    OBJECTIVES: To review the characteristics and performance of research ethics committees in Spain in the evaluation of multicentre clinical trial drug protocols. DESIGN: A prospective study of 100 applications. SETTING: Forty-one committees reviewing clinical trial protocols, involving 50 hospitals in 25 cities. MAIN MEASURES: Protocol-related features, characteristics of research ethics committees and evaluation dynamics. RESULTS: The 100 applications involved 15 protocols (of which 12 were multinational) with 12 drugs. Committees met monthly (except one). They had a mean number of 12 members, requested a mean of six complete dossiers and nine additional copies of the protocol with a mean deadline of 14 days before the meeting. All applications were approved except three (two of the three were open-label long-term safety trials rejected by the same committee), which were approved by the other committees involved. The mean time from submission to approval was 64 days. The mean time from submission to arrival of the approval document at our offices was 85 days. Twenty-five committees raised queries for 38 of the 97 finally approved applications. Impact of evaluation fee, number of members, queries raised and experience of committees on timings were not statistically significant. CONCLUSION: Obtaining ethical approval is time-consuming. There is much diversity in the research ethics committees' performance. A remarkable delay (> 20 days) exists between the decision and the arrival of the written approval, suggesting administrative or organisational problems. PMID:10390685

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

    PubMed

    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.

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

    PubMed Central

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

    2017-01-01

    Introduction 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. Methods and analysis 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. Ethics and dissemination 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. Trial registration

  16. Engaging hospitalized patients in clinical care: Study protocol for a pragmatic randomized controlled trial

    PubMed Central

    Prey, Jennifer; Ryan, Beatriz; Alarcon, Irma; Qian, Min; Bakken, Suzanne; Feiner, Steven; Hripcsak, George; Polubriaginof, Fernanda; Restaino, Susan; Schnall, Rebecca; Strong, Philip; Vawdrey, David

    2016-01-01

    Background Patients who are better informed and more engaged in their health care have higher satisfaction with health care and better health outcomes. While patient engagement has been a focus in the outpatient setting, strategies to engage inpatients in their care have not been well studied. We are undertaking a study to assess how patients’ information needs during hospitalization can be addressed with health information technologies. To achieve this aim, we developed a personalized inpatient portal that allows patients to see who is on their care team, monitor their vital signs, review medications being administered, review current and historical lab and test results, confirm allergies, document pain scores and send questions and comments to inpatient care providers. The purpose of this paper is to describe the protocol for the study. Methods/design This pragmatic randomized controlled trial will enroll 426 inpatient cardiology patients at an urban academic medical center into one of three arms receiving: 1) usual care, 2) iPad with general internet access, or 3) iPad with access to the personalized inpatient portal. The primary outcome of this trial is patient engagement, which is measured through the Patient Activation Measure. To assess scalability and potential reach of the intervention, we are partnering with a West Coast community hospital to deploy the patient engagement technology in their environment with an additional 160 participants. Conclusion This study employs a pragmatic randomized control trial design to test whether a personalized inpatient portal will improve patient engagement. If the study is successful, continuing advances in mobile computing technology should make these types of interventions available in a variety of clinical care delivery settings. PMID:26795675

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

    PubMed Central

    Yunesian, Masud; Asghari, Fariba; Vash, Javad Homayoun; Forouzanfar, Mohammad Hossein; Farhud, Dariush

    2006-01-01

    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 levels that are taken as

  18. Protocol for a prospective, multicentre registry study of stenting for symptomatic intracranial artery stenosis in China

    PubMed Central

    Wang, Yilong; Miao, Zhongrong; Wang, Yongjun; Zhao, Xingquan; Gao, Peiyi; Liu, Liping; Wang, Feng; Liu, Yajie; Ma, Ning; Xu, Ziqi; Mo,, Dapeng; Gao, Feng

    2014-01-01

    Introduction The SAMMPRIS trial suggested that aggressive treatment was superior to endovascular stenting in patients with severe symptomatic intracranial atherosclerotic stenosis (ICAS) due to high complication rates in patients in the stenting group. Given that 12.2% patients failed aggressive medical therapy in the SAMMPRIS study, it is imperative to perform a multicentre prospective registry study of stenting for patients with ICAS in China. This study aims to evaluate the safety and efficacy of endovascular stenting for patients with symptomatic intracranial artery stenosis and poor collaterals in China and to identify the characteristics of the population that would benefit the most from endovascular stenting in Chinese patients. Methods and analysis This multicentre prospective registry study will involve 20 stroke centres in China, and plans to recruit 300 patients into the registry. Patients with ≥70% stenosis and symptomatic intracranial atherosclerotic disease caused by hypoperfusion combined with poor collaterals who met the inclusion criteria and exclusion criteria would be enrolled for this study. The primary outcome is the target vessel stroke event (including haemorrhagic or ischaemic stroke) or death within 30 days after stenting. The secondary outcomes include the successful recanalisation rate, the incidence of recurrent ischaemic stroke in the territory of the stented artery between 30 days and 1 year postoperatively, the restenosis rate and health-related quality of life. Ethics and dissemination The protocol is approved by the ethics committee at the coordinating centre and by the local institutional review board at each participating centre. Findings will be shared with participating hospitals, policymakers and the academic community to promote quality monitoring, quality improvement and the efficient allocation and use of cerebral catheterisation and intracranial artery stenting in China. Trial registration number http

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

    PubMed Central

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

    2015-01-01

    Introduction 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. Methods and analysis 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. Ethics and dissemination 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

  20. Protocol for a scoping review study to identify and classify patient-centred quality indicators

    PubMed Central

    Jolley, Rachel J; Lorenzetti, Diane L; Manalili, Kimberly; Lu, Mingshan; Santana, Maria J

    2017-01-01

    Introduction The concept of patient-centred care (PCC) is changing the way healthcare is understood, accepted and delivered. The Institute of Medicine has defined PCC as 1 of its 6 aims to improve healthcare quality. However, in Canada, there are currently no nationwide standards in place for measuring and evaluating healthcare from a patient-centred approach. In this paper, we outline our scoping review protocol to systematically review published and unpublished literature specific to patient-centred quality indicators that have been implemented and evaluated across various care settings. Methods and analysis Arksey and O'Malley's scoping review methodology framework will guide the conduct of this scoping review. We will search electronic databases (MEDLINE, EMBASE, the Cochrane Library, Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycINFO, Social Work Abstracts, Social Services Abstracts), grey literature sources and the reference lists of key studies to identify studies appropriate for inclusion. 2 reviewers will independently screen all abstracts and full-text studies for inclusion. We will include any study which focuses on quality indicators in the context of PCC. All bibliographic data, study characteristics and indicators will be collected and analysed using a tool developed through an iterative process by the research team. Indicators will be classified according to a predefined conceptual framework and categorised and described using qualitative content analysis. Ethics and dissemination The scoping review will synthesise patient-centred quality indicators and their characteristics as described in the literature. This review will be the first step to formally identify what quality indicators have been used to evaluate PCC across the healthcare continuum, and will be used to inform a stakeholder consensus process exploring the development of a generic set of patient-centred quality indicators applicable to multiple care settings. The

  1. Which dressing do donor site wounds need?: study protocol for a randomized controlled trial

    PubMed Central

    2011-01-01

    Background Donor site wounds after split-skin grafting are rather 'standard' wounds. At present, lots of dressings and topical agents for donor site wounds are commercially available. This causes large variation in the local care of these wounds, while the optimum 'standard' dressing for local wound care is unclear. This protocol describes a trial in which we investigate the effectiveness of various treatment options for these donor site wounds. Methods A 14-center, six-armed randomized clinical trial is being carried out in the Netherlands. An a-priori power analysis and an anticipated dropout rate of 15% indicates that 50 patients per group are necessary, totaling 300 patients, to be able to detect a 25% quicker mean time to complete wound healing. Randomization has been computerized to ensure allocation concealment. Adult patients who need a split-skin grafting operation for any reason, leaving a donor site wound of at least 10 cm2 are included and receive one of the following dressings: hydrocolloid, alginate, film, hydrofiber, silicone dressing, or paraffin gauze. No combinations of products from other intervention groups in this trial are allowed. Optimum application and changes of these dressings are pursued according to the protocol as supplied by the dressing manufacturers. Primary outcomes are days to complete wound healing and pain (using a Visual Analogue Scale). Secondary outcomes are adverse effects, scarring, patient satisfaction, and costs. Outcome assessors unaware of the treatment allocation will assess whether or not an outcome has occurred. Results will be analyzed according to the intention to treat principle. The first patient was randomized October 1, 2009. Discussion This study will provide comprehensive data on the effectiveness of different treatment options for donor site wounds. The dressing(s) that will prevail in effectiveness, satisfaction and costs will be promoted among clinicians dealing with such patients. Thus, we aim to

  2. Evaluating community health centers’ adoption of a new global capitation payment (eCHANGE) study protocol

    PubMed Central

    Angier, H; O’Malley, JP; Marino, M; McConnell, KJ; Cottrell, E; Jacob, RL; Likumahuwa-Ackman, S; Heintzman, J; Huguet, N; Bailey, SR; DeVoe, JE

    2017-01-01

    Primary care patient-centered medical homes (PCMHs) are an effective healthcare delivery model. Evidence regarding the most effective payment models for increased coordination efforts is sparse. This protocol paper describes the evaluation of an Alternative Payment Methodology (APM) implemented in a subset of Oregon community health centers (CHCs), using a prospective matched observational design. The APM is a primary care payment reform intervention that changed Oregon’s Medicaid payment for several CHCs from fee-for-service reimbursement to a per-member-per-month capitated payment. We will implement a difference-in-difference analytic approach to evaluate pre-post APM changes between intervention and control groups, including: 1) clinic-level outcomes, 2) patient-level clinical outcomes, and 3) patient-level econometric outcomes. Findings from the project will be of national significance, as there is a need for evidence regarding how novel payment methods might enhance PCMH capabilities and support their capacity to produce better quality and outcomes. If this capitated payment method is proven effective, study findings will inform dissemination of similar APMs nationwide. PMID:27836506

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

    PubMed

    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.

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

    PubMed Central

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

    2016-01-01

    Background 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. Methods 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. Discussion 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. PMID:27784996

  5. A simple, economical and reproducible protein extraction protocol for proteomics studies of soybean roots.

    PubMed

    Rodrigues, Elisete Pains; Torres, Adalgisa Ribeiro; da Silva Batista, Jesiane Stefânia; Huergo, Luciano; Hungria, Mariangela

    2012-06-01

    Sample preparation is a critical step in two-dimensional gel electrophoresis (2-DE) of plant tissues. Here we describe a phenol/SDS procedure that, although greatly simplified, produced well-resolved and reproducible 2-DE profiles of protein extracts from soybean [Glycine max (L.) Merril] roots. Extractions were made in three replicates using both the original and simplified procedure. To evaluate the quality of the extracted proteins, ten spots were randomly selected and identified by mass spectrometry (MS). The 2-DE gels were equally well resolved, with no streaks or smears, and no significant differences were observed in protein yield, reproducibility, resolution or number of spots. Mass spectra of the ten selected spots were compared with database entries and allowed high-quality identification of proteins. The simplified protocol described here presents considerable savings of time and reagents without compromising the quality of 2-DE protein profiles and compatibility with MS analysis, and may facilitate the progress of proteomics studies of legume-rhizobia interactions.

  6. Bio-Repository of DNA in stroke (BRAINS): A study protocol

    PubMed Central

    2011-01-01

    Background Stroke is one of the commonest causes of mortality in the world and anticipated to be an increasing burden to the developing world. Stroke has a genetic basis and identifying those genes may not only help us define the mechanisms that cause stroke but also identify novel therapeutic targets. However, large scale highly phenotyped DNA repositories are required in order for this to be achieved. Methods The proposed Bio-Repository of DNA in Stroke (BRAINS) will recruit all subtypes of stroke as well as controls from two different continents, Europe and Asia. Subjects recruited from the UK will include stroke patients of European ancestry as well as British South Asians. Stroke subjects from South Asia will be recruited from India and Sri Lanka. South Asian cases will also have control subjects recruited. Discussion We describe a study protocol to establish a large and highly characterized stroke biobank in those of European and South Asian descent. With different ethnic populations being recruited, BRAINS has the ability to compare and contrast genetic risk factors between those of differing ancestral descent as well as those who migrate into different environments. PMID:21366918

  7. Effectiveness of cognitive behavioural therapy augmentation in major depression treatment (ECAM study): study protocol for a randomised clinical trial

    PubMed Central

    Nakagawa, Atsuo; Sado, Mitsuhiro; Mitsuda, Dai; Fujisawa, Daisuke; Kikuchi, Toshiaki; Abe, Takayuki; Sato, Yuji; Iwashita, Satoru; Mimura, Masaru; Ono, Yutaka

    2014-01-01

    Introduction Major depression is a serious mental disorder that causes substantial distress and impairment in individuals and places an enormous burden on society. Although antidepressant treatment is the most common therapy provided in routine practice, there is little evidence to guide second-line therapy for patients who have failed to respond to antidepressants. The aim of this paper is to describe the study protocol for a randomised controlled trial that measures the clinical effectiveness of cognitive behavioural therapy (CBT) as an augmentation strategy to treat patients with non-psychotic major depression identified as suboptimal responders to usual depression care. Methods and analysis The current study is a 16-week assessor-blinded randomised, parallel-groups superiority trial with 12-month follow-up at an outpatient clinic as part of usual depression care. Patients aged 20–65 years with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) Major Depressive Disorder who have experienced at least one failed trial of antidepressants as part of usual depression care, will be randomly assigned to receive CBT plus treatment as usual, or treatment as usual alone. The primary outcome is the change in clinician-rated 17-item GRID-Hamilton Depression Rating Scale (GRID-HAMD) score at 16 weeks, and secondary outcomes include severity and change in scores of subjective depression symptoms, proportion of responders and remitters, safety and quality of life. The primary population will be the intention-to-treat patients. Ethics and dissemination All protocols and the informed consent form comply with the Ethics Guideline for Clinical Research (Japanese Ministry of Health, Labour and Welfare). Ethics review committees at the Keio University School of Medicine and the Sakuragaoka Memorial Hospital approved the study protocol. The results of the study will be disseminated at several research conferences and as published articles in peer

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

    PubMed Central

    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

    2015-01-01

    Introduction 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. Methods 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. Ethics and dissemination 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

  9. Multimorbidity in primary care: protocol of a national cross-sectional study in Switzerland

    PubMed Central

    Déruaz-Luyet, Anouk; N'Goran, A Alexandra; Tandjung, Ryan; Frey, Peter; Zeller, Andreas; Haller, Dagmar M; Rosemann, Thomas; Burnand, Bernard; Bodenmann, Patrick; Senn, Nicolas; Widmer, Daniel; Herzig, Lilli

    2015-01-01

    Introduction With the ageing of the population and the general improvement of care, an increasing number of people are living with multiple chronic health conditions or ‘multimorbidity’. Multimorbidity often implies multiple medical treatments. As a consequence, the risk of adverse events and the time spent by patients for their treatments increase exponentially. In many cases, treatment guidelines traditionally defined for single conditions are not easily applicable. Primary care for individuals with multimorbidity requires complex patient-centred care and good communication between the patient and the general practitioner (GP). This often includes prioritising among the different chronic conditions. Methods and analysis The main objectives of this study are to describe the burden related to multimorbidity (disease-related burden and burden of treatment) in primary care and to identify the factors influencing it. Other objectives include evaluating patients’ perception of treatment burden and quality of life, assessing factors influencing that perception, and investigating prioritisation in the management of multimorbidity from the perspectives of GPs and patients. For this cross-sectional study, patient enrolment will take place in GP's private practices across Switzerland. A convenient sample of 100 GPs will participate; overall, 1000 patients with at least three chronic health conditions will be enrolled. Data will be collected as paper-based questionnaires for GPs and delayed telephone interview questionnaires for patients. GPs will provide demographic and practice-related data. In addition, each GP will complete a paper-based questionnaire for each patient that they enrol. Each patient will complete a telephone interview questionnaire. Ethics and dissemination This study has been approved by the research ethics committee of Canton Vaud, Switzerland (Protocol 315/14). The results of the study will be reported in international peer-reviewed journals. PMID

  10. Acupuncture for low back pain due to spondylolisthesis: study protocol for a randomized controlled pilot trial

    PubMed Central

    2014-01-01

    Background Spondylolisthesis is the major cause of refractory low back pain. There are many studies of the surgical treatment of spondylolisthesis, but few of conservative treatments. There is also no optimal conservative treatment protocol, however, low back pain caused by low-grade spondylolisthesis is controlled with non-surgical pain management. Acupuncture has become a useful method for treating low back pain, but there has not been any study of its efficacy in relation to spondylolisthesis. This study was designed to establish the feasibility of a randomized controlled trial and the safety of acupuncture for low back pain due to low-grade spondylolisthesis. Methods/Design The study is a randomized controlled pilot clinical trial of five weeks duration. Fourteen patients will be recruited and randomly allocated to two groups: an acupuncture plus interlaminar epidural steroid injection group (experimental group), and an interlaminar epidural steroid injection group (control group). All patients will be administered an interlaminar epidural steroid injection once a week for three weeks (three injections in total), but only the experimental group will receive additional treatment with three acupuncture sessions a week for three weeks (nine acupuncture sessions in total). The primary outcome will be measured by the visual analogue scale (VAS). Our primary end point is three-week VAS. The secondary outcome will be measured using the PainVision system, the short-form McGill Pain Questionnaire, and the Oswestry Disability Index. Assessments will be made at baseline and at one, three and five weeks thereafter (that is, the five-week assessment will be made two weeks after treatment cessation). Discussion This randomized controlled pilot trial will inform the design of a further full-scale trial. The outcomes will provide some resources for incorporating acupuncture into existing pain management methods such as interlaminar epidural steroid injection in low

  11. Panax ginseng therapy for chronic obstructive pulmonary disease: a clinical trial protocol and pilot study

    PubMed Central

    2014-01-01

    Background Panax ginseng (Ren shen) has been used to treat chronic obstructive pulmonary disease (COPD). This article aims to present a study protocol and pilot trial comparing P. ginseng with placebo for treating moderate to very severe COPD. Methods COPD was diagnosed spirometrically, with participants having a forced expiratory volume in one second (FEV1) of between 20% and 79% and FEV1 to forced vital capacity (FVC) ratio of less than 70%. Outcome measures included exacerbation rate, St. Georges Respiratory Questionnaire, COPD Assessment Test and Short-form Health Survey (SF-36). Other outcome measures included the six-minute walk test, FEV1, FVC, relief medication use, use of COPD-specific medical resources, and adverse events. The study is a randomized, double-blind, placebo controlled clinical trial. The method of this pilot trial was based on a planned full-scale trial except that participants were enrolled for ten weeks compared to 52 weeks. In the pilot trial, 14 participants (57–73 years old) with moderate to very severe COPD were recruited from a community health program at a public Chinese medicine hospital in Guangdong Province, China. After a 2-week run-in period, 10 participants were eligible for the study and were randomly assigned to either P. ginseng group (n = 5) (200 mg twice daily for four weeks) or placebo group (n = 5), and then followed-up for an additional 4 weeks for a total of 10 weeks. Results Nine participants completed the trial and one dropped out. The exacerbation rate could not be evaluated because there were no exacerbations. One participant in P. ginseng group reported events of sore throat, cough and fever. Trial investigators did not consider these events as COPD exacerbations or adverse events. Conclusions Participant recruitment, study design, data collection and outcome measurement have been tested in a pilot trial. A full-scale trial is warranted. PMID:25161696

  12. Hand, hip and knee osteoarthritis in a Norwegian population-based study - The MUST protocol

    PubMed Central

    2013-01-01

    Background Knowledge about the prevalence and consequences of osteoarthritis (OA) in the Norwegian population is limited. This study has been designed to gain a greater understanding of musculoskeletal pain in the general population with a focus on clinically and radiologically confirmed OA, as well as risk factors, consequences, and management of OA. Methods/Design The Musculoskeletal pain in Ullensaker STudy (MUST) has been designed as an observational study comprising a population-based postal survey and a comprehensive clinical examination of a sub-sample with self-reported OA (MUST OA cohort). All inhabitants in Ullensaker municipality, Norway, aged 40 to 79 years receive the initial population-based postal survey questionnaire with questions about life style, general health, musculoskeletal pain, self-reported OA, comorbidities, health care utilisation, medication use, and functional ability. Participants who self-report OA in their hip, knee and/or hand joints are asked to attend a comprehensive clinical examination at Diakonhjemmet Hospital, Oslo, including a comprehensive medical examination, performance-based functional tests, different imaging modalities, cardiovascular assessment, blood and urine samples, and a number of patient-reported questionnaires including five OA disease specific instruments. Data will be merged with six national data registries. A subsample of those who receive the questionnaire has previously participated in postal surveys conducted in 1990, 1994, and 2004 with data on musculoskeletal pain and functional ability in addition to demographic characteristics and a number of health related factors. This subsample constitutes a population based cohort with 20 years follow-up. Discussion This protocol describes the design of an observational population-based study that will involve the collection of data from a postal survey on musculoskeletal pain, and a comprehensive clinical examination on those with self-reported hand, hip and

  13. Qualitative approach to patient-reported outcomes in oncology: protocol of a French study

    PubMed Central

    Orri, Massimiliano; Sibeoni, Jordan; Labey, Mathilde; Bousquet, Guilhem; Verneuil, Laurence; Revah-Levy, Anne

    2015-01-01

    Introduction The past decade has been characterised by movement from a doctor-centred to a patient-centred approach to treatment outcomes, in which doctors try to see the illness through their patients’ eyes. Patients, family members and doctors are the three participants in cancer care, but their perspectives about what have been helpful during cancer treatment have never simultaneously and explicitly compared in the same qualitative study. The aim of this study project is to explore patients’ perspectives about the care they receive, as well as families’ and doctors’ perspectives about what have been helpful for the patient. These three points of view will be compared and contrasted in order to analyse the convergences and divergences in these perspectives. Methods and analysis This is a national multicentre qualitative study. Participants will be constituted by three different subsamples: (1) patients with cancer (skin, breast, urological and lung cancers), (2) their relatives, and (3) their referring physicians. Recruitment will follow the purposive sample technique, and the final sample size will be determined by data saturation. Data will be collected through open-ended semistructured interviews and independently analysed with NVivo V.10 software by three researchers according to the principles of Interpretative Phenomenological Analysis. Ethics and dissemination The research protocol received approval from the University Paris Descartes review board (IRB number: 20140600001072), and participants will provide written consent. To the best of our knowledge, this is the first study to focus on the simultaneous exploration of the separate points of view of patients, families and doctors about the care received during the cancer care journey. We expect that our findings will help to improve communication and relationships between doctors, patients and families. Comparison of these three points of view will provide information about the convergences and

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

    PubMed Central

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

    2017-01-01

    Introduction 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. Methods and analysis 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. Ethics and dissemination 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

  15. Protocols for nuclei isolation and nuclear protein extraction from the resurrection plant Xerophyta viscosa for proteomic studies.

    PubMed

    Abdalla, Kamal Omer; Thomson, Jennifer Ann; Rafudeen, Muhammad Suhail

    2009-01-15

    The plant nucleus is an important subcellular organelle but the isolation of pure and enriched nuclei from plants and subsequent extraction of nuclear proteins for proteomic studies is challenging. Here, we present protocols for nuclei isolation and nuclear protein extraction from the resurrection plant, Xerophyta viscosa, and show optimization and modification of the most critical steps.

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

    ERIC Educational Resources Information Center

    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…

  17. Study on a Real-Time BEAM System for Diagnosis Assistance Based on a System on Chips Design

    PubMed Central

    Sung, Wen-Tsai; Chen, Jui-Ho; Chang, Kung-Wei

    2013-01-01

    As an innovative as well as an interdisciplinary research project, this study performed an analysis of brain signals so as to establish BrainIC as an auxiliary tool for physician diagnosis. Cognition behavior sciences, embedded technology, system on chips (SOC) design and physiological signal processing are integrated in this work. Moreover, a chip is built for real-time electroencephalography (EEG) processing purposes and a Brain Electrical Activity Mapping (BEAM) system, and a knowledge database is constructed to diagnose psychosis and body challenges in learning various behaviors and signals antithesis by a fuzzy inference engine. This work is completed with a medical support system developed for the mentally disabled or the elderly abled. PMID:23681095

  18. μOrgano: A Lego®-Like Plug & Play System for Modular Multi-Organ-Chips

    PubMed Central

    Loskill, Peter; Marcus, Sivan G.; Mathur, Anurag; Reese, Willie Mae; Healy, Kevin E.

    2015-01-01

    Human organ-on-a-chip systems for drug screening have evolved as feasible alternatives to animal models, which are unreliable, expensive, and at times erroneous. While chips featuring single organs can be of great use for both pharmaceutical testing and basic organ-level studies, the huge potential of the organ-on-a-chip technology is revealed by connecting multiple organs on one chip to create a single integrated system for sophisticated fundamental biological studies and devising therapies for disease. Furthermore, since most organ-on-a-chip systems require special protocols with organ-specific media for the differentiation and maturation of the tissues, multi-organ systems will need to be temporally customizable and flexible in terms of the time point of connection of the individual organ units. We present a customizable Lego®-like plug & play system, μOrgano, which enables initial individual culture of single organ-on-a-chip systems and subsequent connection to create integrated multi-organ microphysiological systems. As a proof of concept, the μOrgano system was used to connect multiple heart chips in series with excellent cell viability and spontaneously physiological beat rates. PMID:26440672

  19. μOrgano: A Lego®-Like Plug & Play System for Modular Multi-Organ-Chips.

    PubMed

    Loskill, Peter; Marcus, Sivan G; Mathur, Anurag; Reese, Willie Mae; Healy, Kevin E

    2015-01-01

    Human organ-on-a-chip systems for drug screening have evolved as feasible alternatives to animal models, which are unreliable, expensive, and at times erroneous. While chips featuring single organs can be of great use for both pharmaceutical testing and basic organ-level studies, the huge potential of the organ-on-a-chip technology is revealed by connecting multiple organs on one chip to create a single integrated system for sophisticated fundamental biological studies and devising therapies for disease. Furthermore, since most organ-on-a-chip systems require special protocols with organ-specific media for the differentiation and maturation of the tissues, multi-organ systems will need to be temporally customizable and flexible in terms of the time point of connection of the individual organ units. We present a customizable Lego®-like plug & play system, μOrgano, which enables initial individual culture of single organ-on-a-chip systems and subsequent connection to create integrated multi-organ microphysiological systems. As a proof of concept, the μOrgano system was used to connect multiple heart chips in series with excellent cell viability and spontaneously physiological beat rates.

  20. Communications protocol

    NASA Technical Reports Server (NTRS)

    Zhou, Xiaoming (Inventor); Baras, John S. (Inventor)

    2010-01-01

    The present invention relates to an improved communications protocol which increases the efficiency of transmission in return channels on a multi-channel slotted Alohas system by incorporating advanced error correction algorithms, selective retransmission protocols and the use of reserved channels to satisfy the retransmission requests.

  1. Chromosome Conformation Capture on Chip (4C): Data Processing.

    PubMed

    Leblanc, Benjamin; Comet, Itys; Bantignies, Frédéric; Cavalli, Giacomo

    2016-01-01

    4C methods are useful to investigate dependencies between regulatory mechanisms and chromatin structures by revealing the frequency of chromatin contacts between a locus of interest and remote sequences on the chromosome. In this chapter we describe a protocol for the data analysis of microarray-based 4C experiments, presenting updated versions of the methods we used in a previous study of the large-scale chromatin interaction profile of a Polycomb response element in Drosophila. The protocol covers data preparation, normalization, microarray probe selection, and the multi-resolution detection of regions with enriched chromatin contacts. A reanalysis of two independent mouse datasets illustrates the versatility of this protocol and the importance of data processing in 4C. Methods were implemented in the R package MRA.TA (Multi-Resolution Analyses on Tiling Array data), and they can be used to analyze ChIP-on-chip data on broadly distributed chromatin components such as histone marks.

  2. A Study on Energy Efficient MAC Protocol of Wireless Sensor Network for Ubiquitous Agriculture

    NASA Astrophysics Data System (ADS)

    Lee, Ho-Chul; Lee, Ji-Woong; Hwang, Jeong-Hwan; Yoe, Hyun

    Various technologies are used in the agricultural sites now. Especially, the recent application of sensor network related technology is quite notable. Considering the efficiency of MAC protocol of WSN is being researched in various aspects, it is believed that a research on how to apply the MAC protocol to agriculture would be also required. This research is based on the sensor node developed by Sunchon University ITRC. Once the sensor nodes are effectively located in the farm, they operate for a long time and they are rarely relocated once installed. The concentration of multiple sensor nodes in a narrow area is another characteristic the sensor node. The purpose of this research is to select a sensor network MAC protocol, which would be most proper to agricultural site with good energy efficiency and excellent transmission delay performance. The applicable protocols such as S-MAC and X-MAC were set up for the installation environment. They were compared and a methodology to select the most optimum protocol to agricultural site is suggested.

  3. Isothermal crystallization kinetics of Poly (lactic acid) studied by ultrafast chip calorimeter

    NASA Astrophysics Data System (ADS)

    Jiang, Jing; Jiang, Wei; Huang, Zijie; Zhou, Dongshan; Xue, Gi

    2012-02-01

    Poly (lactic acid) (PLA) is a biocompatible, biodegradable polymer which has attracted much attention. The crystallization ability, as one of the most factors influencing the physical properties of the biomaterials such as thermal, mechanical, and biodegradable properties, has been widely studied mainly by differential scanning calorimeters. However, although the crystallization of PLA is relatively slow, it's difficult to avoid the crystallization from the nuclei or the structure reorganization of the metastable crystalline formed during the annealing process when we use the normal DSC with the heating rate on the level of tens of K/min. With the chip calorimeter whose scanning rate can go up to 1000 K/s, we can avoid the structure reorganization of metastable crystalline during the heating. In this case we annealed the PLA sample in the 80-120^oC temperature range and found the relationship between the onset the melting temperature Tm and crystallization temperature Tc is Tm= 0.53Tc+ 213.5 and the equilibrium melting temperature is Tm,f =179.6^oC.

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

    PubMed Central

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

    2014-01-01

    Introduction 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. Methods and analysis 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. Ethics and dissemination 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. PMID:25011994

  5. Acoustic Radiation Force Impulse Measurement in Renal Transplantation: A Prospective, Longitudinal Study With Protocol Biopsies.

    PubMed

    Lee, Juhan; Oh, Young Taik; Joo, Dong Jin; Ma, Bo Gyoung; Lee, A-lan; Lee, Jae Geun; Song, Seung Hwan; Kim, Seung Up; Jung, Dae Chul; Chung, Yong Eun; Kim, Yu Seun

    2015-09-01

    Interstitial fibrosis and tubular atrophy (IF/TA) is a common cause of kidney allograft loss. Several noninvasive techniques developed to assess tissue fibrosis are widely used to examine the liver. However, relatively few studies have investigated the use of elastographic methods to assess transplanted kidneys. The aim of this study was to explore the clinical implications of the acoustic radiation force impulse (ARFI) technique in renal transplant patients. A total of 91 patients who underwent living donor renal transplantation between September 2010 and January 2013 were included in this prospective study. Shear wave velocity (SWV) was measured by ARFI at baseline and predetermined time points (1 week and 6 and 12 months after transplantation). Protocol biopsies were performed at 12 months. Instead of reflecting IF/TA, SWVs were found to be related to time elapsed after transplantation. Mean SWV increased continuously during the first postoperative year (P < 0.001). In addition, mixed model analysis showed no correlation existed between SWV and serum creatinine (r = -0.2426, P = 0.0771). There was also no evidence of a relationship between IF/TA and serum creatinine (odds ratio [OR] = 1.220, P = 0.7648). Furthermore, SWV temporal patterns were dependent on the kidney weight to body weight ratio (KW/BW). In patients with a KW/BW < 3.5 g/kg, mean SWV continuously increased for 12 months, whereas it decreased after 6 months in those with a KW/BW ≥ 3.5 g/kg.No significant correlation was observed between SWV and IF/TA or renal dysfunction. However, SWV was found to be related to the time after transplantation. Renal hemodynamics influenced by KW/BW might impact SWV values.

  6. Cancer survivor rehabilitation and recovery: Protocol for the Veterans Cancer Rehabilitation Study (Vet-CaRes)

    PubMed Central

    2013-01-01

    Background Cancer survivors are a rapidly growing and aging population in the U.S., but there are many challenges associated with the survivorship experience such as functional disabilities and psychosocial distress. When viewed next to the general population, Veterans are especially at risk for these challenges as they are older and have a high incidence of co-morbid conditions. While the Institute of Medicine (IOM) has called for further cancer survivorship research to address these challenges, we still know little about this experience from the perspective of aging Veterans. Methods/design We conducted a longitudinal, mixed-methods study over the course of three and a half years at the Boston and Houston VA Medical Centers. We recruited 170 Veterans diagnosed with head and neck, colorectal and esophageal/gastric cancers that were identified from the VA tumor registry. Veterans completed three in-depth interviews, conducted at 6, 12 and 18 months after pathology confirmation, measuring the physical, social and psychological factors related to cancer survivorship. The longitudinal design allowed us to assess any changes in cancer related disability and distress over time. Discussion Weekly teleconference study team meetings were a key aspect to the research process. Issues related to recruitment, data management and analysis, and the dissemination of research results was discussed. Interviewers presented detailed case reports of completed interviews that allowed us to refine our interview protocols. We also discussed issues relevant to the Veteran population of which we were previously unaware and some of the challenges of the research process itself. This novel study produced a robust data set that documents the functional and psychosocial cancer survivorship experiences of aging Veterans. The longitudinal design will help us more fully understand the recovery patterns for this specific population, and identify the unique needs and gaps in health services. PMID

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

    PubMed Central

    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

  8. Angioplasty and stenting for patients with symptomatic intracranial atherosclerosis: study protocol of a randomised controlled trial

    PubMed Central

    Cui, Xiao-Ping; Lin, Min; Mu, Jun-Shan; Ye, Jian-Xin; He, Wen-Qing; Fu, Mao-Lin; Li, Hua; Fang, Jia-Yang; Shen, Feng-Feng; Lin, Hang

    2016-01-01

    Introduction Whether adding percutaneous transluminal angioplasty and stenting (PTAS) to background medical treatment is effective for decreasing the incidence of stroke or death in patients with symptomatic intracranial atherosclerosis (ICAS) is still controversial. We perform a randomised controlled trial to examine the effectiveness and safety of an improved PTAS procedure for patients with ICAS. Methods and analysis A randomised controlled trial will be conducted in three hospitals in China. Eligible patients with ICAS will be randomly assigned to receive medication treatment (MT) plus PTAS or MT alone. The MT will be initiated immediately after randomisation, while the PTAS will be performed when patients report relief of alarm symptoms defined as sudden weakness or numbness. All patients will be followed up at 30 days, 3 and 12 months after randomisation. The primary end point will be the incidence of stroke or death at 30 days after randomisation. Secondary outcomes will be the incidence of ischaemic stroke in the territory of stenosis arteries, the incidence of in-stent restenosis, the Chinese version of the modified Rankin Scale and the Chinese version of the Stroke-Specific Quality of Life (CSQoL). Ethics and dissemination The study protocol is approved by institutional review boards in participating hospitals (reference number FZ20160003, 180PLA20160101 and 476PLA2016007). The results of this study will be disseminated to patients, physicians and policymakers through publication in a peer-reviewed journal or presentations in conferences. It is anticipated that the results of this study will improve the quality of the current PTAS procedure and guide clinical decision-making for patients with ICAS. Trial registration number NCT02689037 PMID:27852711

  9. Patients who discontinued statin treatment: a protocol for cohort study using primary care data

    PubMed Central

    Vinogradova, Yana; Coupland, Carol; Brindle, Peter; Hippisley-Cox, Julia

    2015-01-01

    Introduction Risk thresholds for using statins to prevent cardiovascular disease (CVD) have recently been lowered, so an increasing number of patients are now prescribed these drugs. Although the safety of long-term statin use has been generally established, concerns about the balance of risks and benefits of statins still exist for some medical professionals and patients, and issues concerning their side effects are occasionally widely publicised. This study will report the rates of stopping for statins and also identify any patient groups more likely to stop using statins, so possibly increasing their risk of cardiovascular events. Methods and analysis A prospective open cohort study between 1 January 2002 and 30 September 2014 will be based on the general population of people prescribed statins, using records from UK general practices contributing to the Clinical Practice Research Database (CPRD). Participants aged 25–84 years will enter the cohort on the date of their first prescription for a statin and leave on the earliest date of: a cardiovascular event; death; leaving the practice; the last practice upload date or the study end date. If there are no prescriptions within 90 days after the expected finishing date of a prescription, a patient will be defined as a stopper with the discontinuation outcome date as the expected finishing date. Rates of statin discontinuation will be calculated by calendar year, type and dose of statin, age, and morbidities. Cox proportional regression analyses will be run to identify the most important factors associated with discontinuation. Analyses will be run separately for patients without CVD (primary prevention) and with diagnosed CVD (secondary prevention). Ethics and dissemination The protocol has been reviewed and approved by Independent Scientific Advisory Committee for MHRA Database Research. The results will be published in a peer-reviewed journal. PMID:26493458

  10. False-positive diatom test: a real challenge? A post-mortem study using standardized protocols.

    PubMed

    Lunetta, Philippe; Miettinen, Arto; Spilling, Kristian; Sajantila, Antti

    2013-09-01

    The main criticism of the validity of the diatom test for the diagnosis of drowning is based on the potential ante- and post-mortem penetration of diatoms and the finding of diatoms in bodies of non-drowned human beings. However, qualitative and quantitative studies on diatoms in organs of the non-drowned have yielded both conflicting and contradictory results. In the present study, we have analysed under standardised methods the diatom content in several organs of 14 non-drowned human bodies. Overall, only 9 diatoms (6 entire, 3 fragmented) were disclosed in 6 of the 14 non-drowned bodies. Each of these 6 cadavers had only a single "positive" organ. Six diatoms were found in the bone marrow, 2 in the lung, and one in the pleural liquid. No diatoms were recovered from the brain, liver, kidney, or blood samples of any of these 14 bodies. Moreover, in five additional cadavers, whose lungs were injected, prior autopsy, with a 3.5L solution containing a bi-cellulate diatom culture (Thalassiosira baltica, Thalassiosira levanderi) via tracheostomy, a few diatoms appeared in the pleural cavity and in the blood from the left heart chamber, but none in any other internal organs investigated. The results of the presented study demonstrate that the issue of the false-positive diatom test should not be a logical impediment to the performance of the diatom method. However, strict and standardized protocols aimed at avoiding contamination during sample preparation must be used, appropriate separation values set and taxonomic analysis of all diatoms performed.

  11. Association between obesity and depression in patients with diabetes mellitus type 2; a study protocol

    PubMed Central

    De la Cruz-Cano, Eduardo; Tovilla-Zarate, Carlos Alfonso; Reyes-Ramos, Emilio; Gonzalez-Castro, Thelma Beatriz; Juarez-Castro, Isela; López-Narváez, Maria Lilia; Fresan, Ana

    2015-01-01

    Background: Diabetes mellitus and depression are highly prevalent conditions throughout the world and have significant impact on health outcomes. It has been estimated that diabetes mellitus type 2 affects about 246 million people in the world; nevertheless, incidence varies among countries. There is evidence that depression is associated with a poor metabolic control in patients with type 2 diabetes mellitus that present other health problems (such as hypertension and obesity). The aim of this study protocol is to determine if obesity increases the risk for depression in patient with diabetes type 2. Methods: The analysis will be reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA).The studies suitable for inclusion will be assessed by the Newcastle-Ottawa Scale (NOS) to determine their methodological quality. To identify the studies of interest, we will search on PubMed and EBSCO databases. We will use the following keyword combinations: "Diabetes Mellitus type 2 AND obesity AND depression", "depression AND Diabetes Mellitus type 2", "Diabetes Mellitus type 2 AND body mass index cross sectional study", "depression AND obesity cross-sectional study". Causes for exclusion will be publications that studied patients diagnosed with diabetes mellitus type 1; articles that focused on the treatment and complications of diabetes mellitus type 2; publications that have studied other clinical or psychiatric conditions (for instance, seizure disorder or history of schizophrenia, bipolar disorder, psychotic symptoms or dementia). Conclusion: The results of this study will form the basis for a better understanding of the association between obesity and depression in patients with diabetes mellitus type 2, and will allow development of prediction tools and better interventions. It is evident that several modifiable and non-modifiable risk factors play an important role in the pathogenesis of diabetes among population. Currently

  12. Rationale and Design of a Genetic Study on Cardiometabolic Risk Factors: Protocol for the Tehran Cardiometabolic Genetic Study (TCGS)

    PubMed Central

    Khalili, Davood; Hedayati, Mehdi; Ebrahimi, Ahmad; Hajsheikholeslami, Farhad; Mirmiran, Parvin; Ramezani Tehrani, Fahimeh; Momenan, Amir-Abbas; Ghanbarian, Arash; Amouzegar, Atieh; Amiri, Parisa

    2017-01-01

    Background Cardiometabolic risk factors comprise cardiovascular diseases and/or diabetes, and need to be evaluated in different fields. Objective The primary aim of the Tehran Cardiometabolic Genetic Study (TCGS) is to create a comprehensive genome-wide database of at least 16,000 Tehranians, who are participants of the ongoing Tehran Lipid and Glucose Study (TLGS) cohort. Methods TCGS was designed in collaboration with the Research Institute for Endocrine Sciences and the genetic company deCODE. Participants had already been followed for over a 20-year period for major cardiometabolic-related health events including myocardial infarction, stroke, diabetes mellitus, hypertension, obesity, hyperlipidemia, and familial hypercholesterolemia. Results The TCGS cohort described here comprises 17,186 (86.3%) of the 19,905 TLGS participants who provided a baseline blood sample that was adequate for plasma and deoxyribonucleic acid analysis. This study is comprised of 849 individuals and 3109 families with at least one member having genotype information. Finally, 5977 males and 7422 females with the total genotyping rate of 0.9854 were genotyped with HumanOmniExpress-24-v1-0 bead chips (containing 649,932 single-nucleotide polymorphism loci with an average mean distance of 4 kilobases). Conclusions Investigations conducted within the TCGS will seek to identify relevant patterns of genetic polymorphisms that could be related to cardiometabolic risk factors in participants from Tehran. By linking genome-wide data to the existing databank of TLGS participants, which includes comprehensive behavioral, biochemical, and clinical data on each participant since cohort inception in 1999, the TCGS will also allow exploration of gene-gene and gene-environment interactions as they relate to disease status. PMID:28232301

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

    PubMed Central

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

    2015-01-01

    Introduction 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. Methods and analysis 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. Ethics and dissemination 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. PMID:25678542

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

    NASA Astrophysics Data System (ADS)

    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.

  15. Experimental and modeling studies of ultrasound-assisted release of phenolics from oak chips into model wine.

    PubMed

    Tao, Yang; Zhang, Zhihang; Sun, Da-Wen

    2014-09-01

    The enhancement of release of oak-related compounds from oak chips during wine aging with oak chips may interest the winemaking industry. In this study, the 25-kHz ultrasound waves were used to intensify the mass transfer of phenolics from oak chips into a model wine. The influences of acoustic energy density (6.3-25.8 W/L) and temperature (15-25 °C) on the release kinetics of total phenolics were investigated systematically. The results exhibited that the total phenolic yield released was not affected by acoustic energy density significantly whereas it increased with the increase of temperature during sonication. Furthermore, to describe the mechanism of mass transfer of phenolics in model wine under ultrasonic field, the release kinetics of total phenolics was simulated by both a second-order kinetic model and a diffusion model. The modeling results revealed that the equilibrium concentration of total phenolics in model wine, the initial release rate and effective diffusivity of total phenolics generally increased with acoustic energy density and temperature. In addition, temperature had a negative effect on the second-order release rate constant whereas acoustic energy density had an opposite effect.

  16. Systematic analysis of transrectal prostate biopsies using an ink method and specific histopathologic protocol: a prospective study.

    PubMed

    Parada, David; Calvo, Nahum; Peña, Karla; Morente, Vanesa; Queralt, Rosana; Hernandez, Pilar; Riu, Francesc

    2011-01-01

    Background. Transrectal prostate biopsy is the standard protocol for the screening for prostate cancer. It helps to locate prostatic adenocarcinoma and plan treatment. However, the increasing number of prostate biopsies leads to considerably greater costs for the pathology laboratories. In this study, we compare the traditional method with an ink method in combination with a systematic histopathologic protocol. Methods. Two hundred consecutive transrectal prostate biopsy specimens were received from the radiology department. They were separated into two groups: one hundred were processed as six different specimens in the usual manner. The other one hundred were submitted in six containers, the apex, base, and middle section of which were stained different colours. The samples subject to the ink method were embedded in paraffin and placed in two cassettes which were sectioned using a specific protocol. Results. The comparative study of the nonink and ink methods for histopathologic diagnosis showed no statistical differences as far as diagnostic categories were concerned (P  value < .005). The number of PIN diagnoses increased when the ink method was used, but no statistical differences were found. The ink method led to a cost reduction of 48.86%. Conclusions. Our ink method combined with a specific histopathologic protocol provided the same diagnostic quality, tumor location information as the traditional method, and lower pathology expenses.

  17. A comparative study of three cryopreservation protocols for effective storage of in vitro-grown mint (Mentha Spp.).

    PubMed

    Uchendu, Esther E; Reed, Barbara M

    2008-01-01

    This study was designed to determine the response of diverse mint genotypes to three commonly used cryopreservation techniques. Four mints [Mentha x piperita nothosubsp. citrata (Ehrh.) Briq.; M. canadensis L.; M. australis R. Br, and M. cunninghamii Benth] were cryopreserved using three protocols: controlled rate cooling (CC), encapsulation dehydration (ED) and PVS2 vitrification (VIT). Regrowth of mint species following controlled rate cooling (93 percent) was significantly (P < 0.0001) better than encapsulation dehydration (71 percent) and vitrification (73 percent). All four genotypes responded well to the controlled rate cooling protocol but there was some variability with the other two protocols. Genotype specific response to the individual protocols showed that there were significant differences in the recovery of Mentha x piperita nothosubsp. citrata and M. australis with CC > VIT > ED. There were also significant differences in the recovery of M. cunninghamii and M. canadensis, with CC and ED significantly better than VIT. Regrowth of the shoot tips of these mints ranged from 60 percent to 95 percent for all but one treatment. The overall results of this study compare favorably to other techniques. These improved results may be due to a combination of favorable growth conditions, cold acclimation and recovery medium. Controlled rate cooling was the most successful technique for the storage of these diverse mint genotypes; however recovery of shoot tips from VIT and ED was high and these techniques could also be used for cryogenic storage of mint germplasm.

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

    PubMed Central

    Mokkink, LB; Terwee, CB; Knol, DL; Stratford, PW; Alonso, J; Patrick, DL; Bouter, LM; de Vet, HCW

    2006-01-01

    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 subsequently be field

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

    PubMed Central

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

    2016-01-01

    Introduction 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. Methods and analysis 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). Ethics and

  20. Different consecutive training protocols to design an intervention program for overweight youth: a controlled study

    PubMed Central

    Fiorilli, Giovanni; Iuliano, Enzo; Aquino, Giovanna; Campanella, Emidio; Tsopani, Despina; Di Costanzo, Alfonso; Calcagno, Giuseppe; di Cagno, Alessandra

    2017-01-01

    Objective To find the optimal exercise program to be recommended in reducing adiposity and promoting long-term physical activity adherence in a sample of overweight adolescents. Methods Forty-five overweight adolescents were randomly divided into three exercise groups, to perform two phases of physical activity as follows: in the first phase, the first group performed a 16-week moderate-intensity resistance training (RT), the second group performed a 16-week high-intensity RT, and the third group performed a 16-week aerobic training (AT); in the second phase, all groups performed a 6-week AT. Anthropometric body composition and fitness measures were considered as outcome measures. Results After the second protocol, both RT groups showed a significant improvement in percentage of fat mass (F2,76 = 5.843; p = 0.004; h2 = 0.133) and free fat mass (F2,76 = 6.254; p = 0.003; h2 = 0.141), and in fitness tests (p < 0.01). The VO2max values of the RT groups were significantly higher than those of the AT group (F2,38 = 4.264; p = 0.021; h2 = 0.183). The rate of adherence to exercise was an average of 94% in both RT groups, whereas in the AT group, it was 83%. During the 12-week post-intervention follow-up, the number of participants who continued to perform physical activities was significantly higher in both the RT groups than in the AT group (p < 0.05). Conclusion The present study provides preliminary evidence that moderate-to-intense RT, followed by AT, can be an effective treatment for overweight adolescents, and the positive effects are maintained even after 12 weeks of follow-up. PMID:28144155

  1. Staged transthoracic approach to persistent atrial fibrillation (TOP-AF): study protocol for a randomized trial

    PubMed Central

    2014-01-01

    Background Persistent atrial fibrillation frequently shows multiple different electrophysiological mechanisms of induction. This heterogeneity causes a low success rate of single procedures of ablation and a high incidence of recurrence. Surgical ablation through bilateral thoracotomy demonstrates better results after a single procedure. Prospective observational studies in inhomogeneous populations without control groups report a remarkable 90% of success with hybrid or staged procedures of surgical ablation coupled with catheter ablation. In this trial, we will examine the hypothesis that a staged approach involving initial minimally invasive surgical ablation of persistent atrial fibrillation, followed by a second percutaneous procedure in case of recurrence, has a higher success rate than repeated percutaneous procedures. Methods/Design This is a controlled (2:1) randomized trial comparing use of a percutaneous catheter with minimally invasive transthoracic surgical ablation of persistent atrial fibrillation. The inclusion and exclusion criteria, definitions, and treatment protocols are those reported by the 2012 Expert Consensus Statement on catheter and surgical ablation of atrial fibrillation. Patients will be randomized to either percutaneous catheter (n = 100) or surgical (n = 50) ablation as the first procedure. After 3 months, they are re-evaluated, according to the same guidelines, and receive a second procedure if necessary. Crossover will be allowed and data analyzed on an “intention-to-treat” basis. Primary outcomes are the incidence of sinus rhythm at 6 and 12 months and the proportions of patients requiring a second procedure. Discussion The use of a staged strategy combining surgical and percutaneous approaches might be more favorable in treatment of persistent atrial fibrillation than the controversial single percutaneous ablation. Trial registration ISRCTN08035058 Reg 06.20.2013 PMID:24885377

  2. On Kill Curves and Sampling Protocols: Studying the Relationships between Impact and Extinction

    NASA Astrophysics Data System (ADS)

    Ward, Peter D.

    1997-05-01

    The pioneering efforts of Raup (1990) have suggested that a relationship exists between crater diameter and percentage of organisms killed as a result of meteor or comet impact with the Earth. The new data (coming from study of the Manson and Chicxulub craters) suggest that the nature of target rock may be a factor nearly as important as impacter size, and that other aspects of the target, including its latitude, the atmospheric and climate conditions characterizing the Earth, as well as the stage of biological evolution and community development at the time of impact are factors which all must be factored into any new kill curve. It may be that no single 'curve' is appropriate, but that a family of curves may be necessary to model the biological effects of large impacts. We propose that a new protocol be developed to better constrain and understand the relationship between impact and extinction. Rather than searching known mass extinction boundaries for evidence of impact (an exercise which up to now has demonstrated that only the Chicxulub crater can be unambiguously related to a mass extinction of planetary scale), we propose that four known craters be investigated to see if they are temporally correlated with extinction at any detectable level. We suggest that Kara, Popigai, Manson, and Manicouagan Craters be investigated in the following way. First, what is their age? The Manson lesson is that the first step in understanding the relationship between impact and extinction is through reliable age dating. Second, can distal components of the impact ejecta (spherules, shocked quartz, and mineral signatures) be located from sedimentary record? Third, once identified, do these signatures coincide with paleontological or geochemical markers of extinction in either the synoptic literature, or from actual outcrops (or deep sea cores).

  3. Study protocol: first nationwide comparative audit of acute lower gastrointestinal bleeding in the UK

    PubMed Central

    Oakland, Kathryn; Guy, Richard; Uberoi, Raman; Seeney, Frances; Collins, Gary; Grant-Casey, John; Mortensen, Neil; Murphy, Mike; Jairath, Vipul

    2016-01-01

    Introduction Acute lower gastrointestinal bleeding (LGIB) is a common indication for emergency hospitalisation worldwide. In contrast to upper GIB, patient characteristics, modes of investigation, transfusion, treatment and outcomes are poorly described. There are minimal clinical guidelines to inform care pathways and the use of endoscopy, including (diagnostic and therapeutic yields), interventional radiology and surgery are poorly defined. As a result, there is potential for wide variation in practice and clinical outcomes. Methods and analysis The UK Lower Gastrointestinal Bleeding Audit is a large nationwide audit of adult patients acutely admitted with LGIB or those who develop LGIB while hospitalised for another reason. Consecutive, unselected presentations with LGIB will be enrolled prospectively over a 2-month period at the end of 2015 and detailed data will be collected on patient characteristics, comorbidities, use of anticoagulants, transfusion, timing and modalities of diagnostic and therapeutic procedures, clinical outcome, length of stay and mortality. These will be audited against predefined minimum standards of care for LGIB. It is anticipated that over 80% of all acute hospitals in England and some hospitals in Scotland, Wales and Northern Ireland will participate. Data will be collected on the availability and organisation of care, provision of diagnostic and therapeutic GI endoscopy, interventional radiology, surgery and transfusion protocols. Ethics and dissemination This audit will be conducted as part of the national comparative audit programme of blood transfusion through collaboration with specialists in gastroenterology, surgery and interventional radiology. Individual reports will be provided to each participant site as well as an overall report and disseminated through specialist societies. Results will also be published in peer-reviewed journals. The study has been funded by National Health Services (NHS) Blood and Transplant and the

  4. Advance care planning in patients with incurable cancer: study protocol for a randomised controlled trial

    PubMed Central

    Clayton, Josephine; Butow, Phyllis N; Silvester, William; Detering, Karen; Hall, Jane; Kiely, Belinda E; Cebon, Jonathon; Clarke, Stephen; Bell, Melanie L; Stockler, Martin; Beale, Phillip; Tattersall, Martin H N

    2016-01-01

    Introduction There is limited evidence documenting the effectiveness of Advance Care Planning (ACP) in cancer care. The present randomised trial is designed to evaluate whether the administration of formal ACP improves compliance with patients' end-of-life (EOL) wishes and patient and family satisfaction with care. Methods and analysis A randomised control trial in eight oncology centres across New South Wales and Victoria, Australia, is designed to assess the efficacy of a formal ACP intervention for patients with cancer. Patients with incurable cancer and an expected survival of 3–12 months, plus a nominated family member or friend will be randomised to receive either standard care or standard care plus a formal ACP intervention. The project sample size is 210 patient–family/friend dyads. The primary outcome measure is family/friend-reported: (1) discussion with the patient about their EOL wishes and (2) perception that the patient's EOL wishes were met. Secondary outcome measures include: documentation of and compliance with patient preferences for medical intervention at the EOL; the family/friend's perception of the quality of the patient's EOL care; the impact of death on surviving family; patient–family and patient–healthcare provider communication about EOL care; patient and family/friend satisfaction with care; quality of life of patient and family/friend subsequent to trial entry, the patient's strength of preferences for quality of life and length of life; the costs of care subsequent to trial entry and place of death. Ethics and dissemination Ethical approval was received from the Sydney Local Health District (RPA Zone) Human Research Ethical Committee, Australia (Protocol number X13-0064). Study results will be submitted for publication in peer-reviewed journals and presented at national and international conferences. Trial registration number Pre-results; ACTRN12613001288718. PMID:27909034

  5. Cognitive Dysfunction Survey of the Japanese Patients with Moyamoya Disease (COSMO-JAPAN Study): Study Protocol

    PubMed Central

    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. PMID:25739435

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

    PubMed

    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.

  7. Community paediatric respiratory infection surveillance study protocol: a feasibility, prospective inception cohort study

    PubMed Central

    Anderson, Emma C; Ingle, Suzanne Marie; Muir, Peter; Beck, Charles; Finn, Adam; Leeming, John Peter; Cabral, Christie; Kesten, Joanna May; Hay, Alastair D

    2016-01-01

    Introduction Paediatric respiratory tract infections (RTIs) are common reasons for primary care consultations and antibiotic prescribing. Locally relevant syndromic and microbiological surveillance information has the potential to improve the care of children with RTIs by normalising illness (parents) and reducing uncertainty (clinicians). Currently, most RTI studies are conducted at the point of healthcare service consultation, leaving the community burden, microbiology, symptom duration and proportion consulting largely unknown. This study seeks to establish the feasibility of (mainly online) participant recruitment and retention, and the acceptability/comparability of parent versus nurse-collected microbiological sampling, to inform the design of a future surveillance intervention study. Evidence regarding consultation rates and symptom duration is also sought. Methods and analysis A community-based, feasibility prospective inception cohort study, recruiting children aged ≥3 months and <16 years and their parents via general practitioner surgery invitation letter, aiming to collect data on 300 incident RTIs by July 2016. Following informed consent, parents provide baseline (demographic) data online, and respond to weekly emails to confirm the absence/presence of new RTI symptoms. Once symptomatic, parents provide daily data online (RTI symptoms, school/day-care attendance, time off work, health service use, medication), and a research nurse visits to collect clinical examination data and microbiological (nasal and saliva) swabs. Parents are invited to provide symptomatic (at nurse visit, but without nurse assistance) and asymptomatic (alone) swabs on recovery. A review of primary care medical notes will gather medical history, health service utilisation, referral and antibiotic prescribing rates. Feasibility will be assessed using recruitment and retention rates, data completeness; and acceptability by quantitative survey and qualitative interviews

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

    PubMed Central

    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

  9. The Study to Understand Mortality and Morbidity in COPD (SUMMIT) study protocol.

    PubMed

    Vestbo, Jørgen; Anderson, Julie; Brook, Robert D; Calverley, Peter M A; Celli, Bartolome R; Crim, Courtney; Haumann, Brett; Martinez, Fernando J; Yates, Julie; Newby, David E

    2013-05-01

    Chronic obstructive pulmonary disease (COPD) often coexists with other chronic diseases and comorbidities that can markedly influence patients' health status and prognosis. This is particularly true for cardiovascular disease (CVD). However, there have been no trials assessing the effect of COPD medications on CVD in patients with both diseases. The "Study to Understand Mortality and Morbidity in COPD" (SUMMIT) aims at determining the impact of fluticasone furoate/vilanterol combination and the individual components on the survival of patients with moderate COPD and either a history of CVD or at increased risk for CVD. SUMMIT is a multicentre, randomised, double-blind, parallel-group, placebo-controlled trial of 16 000 patients with moderate COPD randomly assigned to once daily treatment with fluticasone furoate/vilanterol (100/25 μg), fluticasone furoate (100 μg), vilanterol (25 μg) or matched placebo; mortality is the primary end-point. The study is an event-driven trial powered by the comparison of furoate/vilanterol versus placebo. Secondary end-points are decline in forced expiratory volume in 1 s and effect on a composite cardiovascular end-point. This article describes the design of the SUMMIT study.

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

    PubMed Central

    2015-01-01

    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. PMID:26858757

  11. Protocols for Online Teaching of Thucydides: The "Final Word" Case Study

    ERIC Educational Resources Information Center

    Aravani, ?vangelia

    2015-01-01

    This paper sets out to describe and analyze issues relating to the role of new literacies and technologies in the teaching process. More specifically, the article deals with how the educational design process of Ancient Greek changes through the implementation of technology by using online discussion protocols. These were utilized as a tool for…

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

    PubMed

    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.

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

    PubMed

    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 <90 mmHg at ICU admission or lactate >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. Postoperative Delirium after elective and emergency surgery: analysis and checking of risk factors. A study protocol

    PubMed Central

    Agnoletti, Vanni; Ansaloni, Luca; Catena, Fausto; Chattat, Rabbih; De Cataldis, Angelo; Di Nino, Gianfranco; Franceschi, Claudio; Gagliardi, Stefano; Melotti, Rita Maria; Potalivo, Antonella; Taffurelli, Mario

    2005-01-01

    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 and > 2 lt), Blood transfusions (< 2 lt and > 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. PMID:15921527

  15. Early active motion protocol following open reduction internal fixation of the scaphoid: A pilot study.

    PubMed

    Dunn, J-C; Kusnezov, N; Fares, A; Buccino, Z; Esquivel, D; Mitchell, J

    2017-02-01

    Scaphoid fractures are common injuries which traditionally have been treated with long periods of immobilization even after open reduction and internal fixation (ORIF). The purpose of this pilot investigation was two-fold: 1) describe a precise postoperative Early Active Motion (EAM) rehabilitation protocol following ORIF of scaphoid fractures and 2) record the outcomes of the EAM protocol. Eight consecutive patients having undergone ORIF of the scaphoid were enrolled in the EAM and followed for a minimum of 1 year. At 12 weeks, Disabilities of the Arm Shoulder and Hand (DASH) score, Mayo Wrist score, and range of motion values were obtained. At 1 year, a telephone survey was conducted and several data points were obtained including DASH and Mayo Wrist score, number of push-ups, satisfaction with surgery and ability to remain on active duty. All 8 patients were male, on active duty, with an average age of 26 years. Two patients used tobacco products and none had major health problems. All patients completed the EAM protocol and obtained CT; all CT exams demonstrated healing at 8 weeks. At 12 weeks postoperatively, the average DASH score was 8.8±16 (range: 0-47.5), Mayo wrist score was 88±10 (range: 75-100) and range of motion nearly symmetrical. At a mean final follow-up of 15.4 months postoperatively, the average DASH score was 1.1±1.7 (Range: 0-4.5), Mayo wrist score was 97.5±4 (range 90-100), average number of push-ups was 57 (40-70) at the prior Army Physical Fitness Test. All patients were satisfied with surgery and all remained on active duty at 1 year. There were no reported complications. The EAM protocol following scaphoid fracture ORIF is safe and effective. The EAM can reliably return patients back to high demand activity earlier than a traditional protocol.

  16. Predictors of lower extremity injuries in team sports (PROFITS-study): a study protocol

    PubMed Central

    Pasanen, Kati; Rossi, Marko T; Parkkari, Jari; Heinonen, Ari; Steffen, Kathrin; Myklebust, Grethe; Krosshaug, Tron; Vasankari, Tommi; Kannus, Pekka; Avela, Janne; Kulmala, Juha-Pekka; Perttunen, Jarmo; Kujala, Urho M; Bahr, Roald

    2015-01-01

    Introduction Several intrinsic risk factors for lower extremity injuries have been proposed, including lack of proper knee and body control during landings and cutting manoeuvres, low muscular strength, reduced balance and increased ligament laxity, but there are still many unanswered questions. The overall aim of this research project is to investigate anatomical, biomechanical, neuromuscular, genetic and demographic risk factors for traumatic non-contact lower extremity injuries in young team sport athletes. Furthermore, the research project aims to develop clinically oriented screening tools for predicting future injury risk. Methods Young female and male players (n=508) from nine basketball teams, nine floorball teams, three ice hockey teams, and one volleyball team accepted the invitation to participate in this four-and-half-year prospective follow-up study. The players entered the study either in 2011, 2012 or 2013, and gave blood samples, performed physical tests and completed the baseline questionnaires. Following the start of screening tests, the players will be followed for sports injuries through December 2015. The primary outcome is a traumatic non-contact lower extremity injury. The secondary outcomes are other sports-related injuries. Injury risk is examined on the basis of anatomical, biomechanical, neuromuscular, genetic and other baseline factors. Univariate and multivariate regression models will be used to investigate association between investigated parameters and injury risk. PMID:27900143

  17. Characterizing Diversity of Lactobacilli Associated with Severe Early Childhood Caries: A Study Protocol

    PubMed Central

    Argimón, Silvia; Schön, Catherine N.; Saraithong, Prakaimuk; Caufield, Page W.

    2015-01-01

    will be compared between children with or without S-ECC. One of the main objectives of this study is to establish a study protocol for the identification and characterization of lactobacilli in the oral cavity. Future caries risk assessments can include lactobacilli counts (quantitative) and the presence/absence of specific cariogenic genetic signatures of a Lactobacillus species (qualitative) associated with S-ECC. PMID:26413427

  18. Improving adherence to web-based cessation programs: a randomized controlled trial study protocol

    PubMed Central

    2013-01-01

    Background Reducing smoking prevalence is a public health priority that can save more lives and money than almost any other known preventive intervention. Internet interventions have the potential for enormous public health impact given their broad reach and effectiveness. However, most users engage only minimally with even the best designed websites, diminishing their impact due to an insufficient ‘dose’. Two approaches to improve adherence to Internet cessation programs are integrating smokers into an online social network and providing free nicotine replacement therapy (NRT). Active participation in online communities is associated with higher rates of cessation. Integrating smokers into an online social network can increase support and may also increase utilization of cessation tools and NRT. Removing barriers to NRT may increase uptake and adherence, and may also increase use of online cessation tools as smokers look for information and support while quitting. The combination of both strategies may exert the most powerful effects on adherence compared to either strategy alone. Methods/Design This study compares the efficacy of a smoking cessation website (WEB) alone and in conjunction with free NRT and a social network (SN) protocol designed to integrate participants into the online community. Using a 2 (SN, no SN) x 2 (NRT, no NRT) randomized, controlled factorial design with repeated measures at baseline, 3 months, and 9 months, this study will recruit N = 4,000 new members of an internet cessation program and randomize them to: 1) WEB, 2) WEB + SN, 3) WEB + NRT, or 4) WEB + SN + NRT. Hypotheses are that all interventions will outperform WEB and that WEB + SN + NRT will outperform WEB + NRT and WEB + SN on 30-day point prevalence abstinence at 9 months. Exploratory analyses will examine theory-driven hypotheses about the mediators and moderators of outcome. Discussion Addressing adherence in internet cessation programs is critical and timely to leverage

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

    PubMed Central

    2013-01-01

    Background 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. Methods/design 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

  20. Protocol Design for Large-Scale Cross-Sectional Studies of Sexual Abuse and Associated Factors in Individual Sports: Feasibility Study in Swedish Athletics

    PubMed Central

    Timpka, Toomas; Janson, Staffan; Jacobsson, Jenny; Ekberg, Joakim; Dahlström, Örjan; Kowalski, Jan; Bargoria, Victor; Mountjoy, Margo; Svedin, Carl G.

    2015-01-01

    To ensure health and well-being for their athletes, sports organizations must offer preventive measures against sexual abuse. The aim of this study was to design and evaluate feasibility of a research protocol for cross-sectional epidemiological studies of sexual abuse in athletics. Examination of the requirements on the study of sexual abuse in athletics was followed by iterated drafting of protocol specifications and formative evaluations. The feasibility of the resulting protocol was evaluated in a national-level study among elite athletics athletes (n = 507) in Sweden. The definition of sexual abuse, the ethical soundness of the protocol, reference populations and study of co-morbidity, and the means for athlete-level data collection were identified as particularly complex issues in the requirements analyses. The web-based survey defined by the protocol facilitates anonymous athlete self-reporting of data on exposure to sexual abuse. 198 athletes (39%) fully completed the feasibility survey. 89% (n = 177) reported that they agreed with that the questions in the survey were important, and 95% (n = 189) reported that they answered truthfully to all questions. Similarly, 91% (n = 180) reported that they did not agree with that the questions were unpleasant for them. However, 16% (n = 32) reported that they did not find the survey to be of personal value, and 12% (n = 23) reported that the survey had caused them to think about issues that they did not want to think about. Responding that participation was not personally gratifying was associated with training more hours (p = 0.01). There is a scarcity of research on the prevention of sexual abuse in individual sports. The present protocol should be regarded as a means to overcome this shortcoming in athletics. When implementing the protocol, it is necessary to encourage athlete compliance and to adapt the web-based survey to the particular infrastructural conditions in the sports setting at hand. Key points A

  1. Protocol design for large-scale cross-sectional studies of sexual abuse and associated factors in individual sports: feasibility study in Swedish athletics.

    PubMed

    Timpka, Toomas; Janson, Staffan; Jacobsson, Jenny; Ekberg, Joakim; Dahlström, Örjan; Kowalski, Jan; Bargoria, Victor; Mountjoy, Margo; Svedin, Carl G

    2015-03-01

    To ensure health and well-being for their athletes, sports organizations must offer preventive measures against sexual abuse. The aim of this study was to design and evaluate feasibility of a research protocol for cross-sectional epidemiological studies of sexual abuse in athletics. Examination of the requirements on the study of sexual abuse in athletics was followed by iterated drafting of protocol specifications and formative evaluations. The feasibility of the resulting protocol was evaluated in a national-level study among elite athletics athletes (n = 507) in Sweden. The definition of sexual abuse, the ethical soundness of the protocol, reference populations and study of co-morbidity, and the means for athlete-level data collection were identified as particularly complex issues in the requirements analyses. The web-based survey defined by the protocol facilitates anonymous athlete self-reporting of data on exposure to sexual abuse. 198 athletes (39%) fully completed the feasibility survey. 89% (n = 177) reported that they agreed with that the questions in the survey were important, and 95% (n = 189) reported that they answered truthfully to all questions. Similarly, 91% (n = 180) reported that they did not agree with that the questions were unpleasant for them. However, 16% (n = 32) reported that they did not find the survey to be of personal value, and 12% (n = 23) reported that the survey had caused them to think about issues that they did not want to think about. Responding that participation was not personally gratifying was associated with training more hours (p = 0.01). There is a scarcity of research on the prevention of sexual abuse in individual sports. The present protocol should be regarded as a means to overcome this shortcoming in athletics. When implementing the protocol, it is necessary to encourage athlete compliance and to adapt the web-based survey to the particular infrastructural conditions in the sports setting at hand. Key points

  2. Edge chipping and flexural resistance of monolithic ceramics☆

    PubMed Central

    Zhang, Yu; Lee, James J.-W.; Srikanth, Ramanathan; Lawn, Brian R.

    2014-01-01

    Objective Test the hypothesis that monolithic ceramics can be developed with combined esthetics and superior fracture resistance to circumvent processing and performance drawbacks of traditional all-ceramic crowns and fixed-dental-prostheses consisting of a hard and strong core with an esthetic porcelain veneer. Specifically, to demonstrate that monolithic prostheses can be produced with a much reduced susceptibility to fracture. Methods Protocols were applied for quantifying resistance to chipping as well as resistance to flexural failure in two classes of dental ceramic, microstructurally-modified zirconias and lithium disilicate glass–ceramics. A sharp indenter was used to induce chips near the edges of flat-layer specimens, and the results compared with predictions from a critical load equation. The critical loads required to produce cementation surface failure in monolithic specimens bonded to dentin were computed from established flexural strength relations and the predictions validated with experimental data. Results Monolithic zirconias have superior chipping and flexural fracture resistance relative to their veneered counterparts. While they have superior esthetics, glass–ceramics exhibit lower strength but higher chip fracture resistance relative to porcelain-veneered zirconias. Significance The study suggests a promising future for new and improved monolithic ceramic restorations, with combined durability and acceptable esthetics. PMID:24139756

  3. An ImmunoChip study of multiple sclerosis risk in African Americans.

    PubMed

    Isobe, Noriko; Madireddy, Lohith; Khankhanian, Pouya; Matsushita, Takuya; Caillier, Stacy J; Moré, Jayaji M; Gourraud, Pierre-Antoine; McCauley, Jacob L; Beecham, Ashley H; Piccio, Laura; Herbert, Joseph; Khan, Omar; Cohen, Jeffrey; Stone, Lael; Santaniello, Adam; Cree, Bruce A C; Onengut-Gumuscu, Suna; Rich, Stephen S; Hauser, Stephen L; Sawcer, Stephen; Oksenberg, Jorge R

    2015-06-01

    The aims of this study were: (i) to determine to what degree multiple sclerosis-associated loci discovered in European populations also influence susceptibility in African Americans; (ii) to assess the extent to which the unique linkage disequilibrium patterns in African Americans can contribute to localizing the functionally relevant regions or genes; and (iii) to search for novel African American multiple sclerosis-associated loci. Using the ImmunoChip custom array we genotyped 803 African American cases with multiple sclerosis and 1516 African American control subjects at 130 135 autosomal single nucleotide polymorphisms. We conducted association analysis with rigorous adjustments for population stratification and admixture. Of the 110 non-major histocompatibility complex multiple sclerosis-associated variants identified in Europeans, 96 passed stringent quality control in our African American data set and of these, >70% (69) showed over-representation of the same allele amongst cases, including 21 with nominally significant evidence for association (one-tailed test P < 0.05). At a further eight loci we found nominally significant association with an alternate correlated risk-tagging single nucleotide polymorphism from the same region. Outside the regions known to be associated in Europeans, we found seven potentially associated novel candidate multiple sclerosis variants (P < 10(-4)), one of which (rs2702180) also showed nominally significant evidence for association (one-tailed test P = 0.034) in an independent second cohort of 620 African American cases and 1565 control subjects. However, none of these novel associations reached genome-wide significance (combined P = 6.3 × 10(-5)). Our data demonstrate substantial overlap between African American and European multiple sclerosis variants, indicating common genetic contributions to multiple sclerosis risk.

  4. The role of body-on-a-chip devices in drug and toxicity studies.

    PubMed

    Esch, M B; King, T L; Shuler, M L

    2011-08-15

    High-quality, in vitro screening tools are essential in identifying promising compounds during drug development. Tests with currently used cell-based assays provide an indication of a compound's potential therapeutic benefits to the target tissue, but not to the whole body. Data obtained with animal models often cannot be extrapolated to humans. Multicompartment microfluidic-based devices, particularly those that are physical representations of physiologically based pharmacokinetic (PBPK) models, may contribute to improving the drug development process. These scaled-down devices, termed micro cell culture analogs (μCCAs) or body-on-a-chip devices, can simulate multitissue interactions under near-physiological fluid flow conditions and with realistic tissue-to-tissue size ratios. Because the device can be used with both animal and human cells, it can facilitate cross-species extrapolation. Used in conjunction with PBPK models, the devices permit an estimation of effective concentrations that can be used for studies with animal models or predict the human response. The devices also provide a means for relatively high-throughput screening of drug combinations and, when utilized with a patient's tissue sample, an opportunity for individualized medicine. Here we review efforts made toward the development of microfabricated cell culture systems and give examples that demonstrate their potential use in drug development, such as identifying synergistic drug interactions as well as simulating multiorgan metabolic interactions. In addition to their use in drug development, the devices also can be used to estimate the toxicity of chemicals as occupational hazards and environmental contaminants.

  5. An ImmunoChip study of multiple sclerosis risk in African Americans

    PubMed Central

    Isobe, Noriko; Madireddy, Lohith; Khankhanian, Pouya; Matsushita, Takuya; Caillier, Stacy J.; Moré, Jayaji M.; Gourraud, Pierre-Antoine; McCauley, Jacob L.; Beecham, Ashley H.; Piccio, Laura; Herbert, Joseph; Khan, Omar; Cohen, Jeffrey; Stone, Lael; Santaniello, Adam; Cree, Bruce A. C.; Onengut-Gumuscu, Suna; Rich, Stephen S.; Hauser, Stephen L.; Sawcer, Stephen

    2015-01-01

    The aims of this study were: (i) to determine to what degree multiple sclerosis-associated loci discovered in European populations also influence susceptibility in African Americans; (ii) to assess the extent to which the unique linkage disequilibrium patterns in African Americans can contribute to localizing the functionally relevant regions or genes; and (iii) to search for novel African American multiple sclerosis-associated loci. Using the ImmunoChip custom array we genotyped 803 African American cases with multiple sclerosis and 1516 African American control subjects at 130 135 autosomal single nucleotide polymorphisms. We conducted association analysis with rigorous adjustments for population stratification and admixture. Of the 110 non-major histocompatibility complex multiple sclerosis-associated variants identified in Europeans, 96 passed stringent quality control in our African American data set and of these, >70% (69) showed over-representation of the same allele amongst cases, including 21 with nominally significant evidence for association (one-tailed test P < 0.05). At a further eight loci we found nominally significant association with an alternate correlated risk-tagging single nucleotide polymorphism from the same region. Outside the regions known to be associated in Europeans, we found seven potentially associated novel candidate multiple sclerosis variants (P < 10−4), one of which (rs2702180) also showed nominally significant evidence for association (one-tailed test P = 0.034) in an independent second cohort of 620 African American cases and 1565 control subjects. However, none of these novel associations reached genome-wide significance (combined P = 6.3 × 10−5). Our data demonstrate substantial overlap between African American and European multiple sclerosis variants, indicating common genetic contributions to multiple sclerosis risk. PMID:25818868

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

    PubMed Central

    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

  7. Computational Protocol for Modeling Thermochromic Molecular Crystals: Salicylidene Aniline As a Case Study.

    PubMed

    Presti, Davide; Labat, Fréderic; Pedone, Alfonso; Frisch, Michael J; Hratchian, Hrant P; Ciofini, Ilaria; Menziani, Maria Cristina; Adamo, Carlo

    2014-12-09

    A computational protocol that combines periodic and QM/QM' calculations has been applied to investigate the structural (geometrical and electronic) and photophysical absorption properties of the salicylidene aniline (SA) thermochromic molecular crystal. The protocol consists of three different steps, namely (i) the description of the molecular crystal using a periodic approach taking into account dispersion interactions, (ii) the identification of reliable finite models (clusters), and (iii) the calculation of vertical transition energies including environmental effects through the use of an electronic embedding model (QM/QM' ONIOM approach). The encouraging results obtained in this work for the β polymorph of SA, both in terms of accuracy and computational cost, open the way to the simulation and the prediction of the photophysical behavior of other molecular crystals, especially those much less well characterized experimentally.

  8. Cactus and Visapult: A case study of ultra-high performance distributed visualization using connectionless protocols

    SciTech Connect

    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.

  9. A Tribolium castaneum whole-embryo culture protocol for studying the molecular mechanisms and morphogenetic movements involved in insect development.

    PubMed

    Macaya, Constanza C; Saavedra, Patricio E; Cepeda, Rodrigo E; Nuñez, Viviana A; Sarrazin, Andres F

    2016-01-01

    The development of the red flour beetle Tribolium castaneum is more representative of arthropods than the evolutionarily derived fly, Drosophila melanogaster. Thus, Tribolium is becoming an emerging organism model for studying the evolution of the mechanisms that control embryonic development in arthropods. In this regard, diverse genetic and molecular tools are currently available for Tribolium, as well as imaging and embryonic techniques. Recently, we developed a method for culturing embryos in order to study specific stages during Tribolium development. In this report, we present a detailed and "easy-to-follow" protocol for embryo handling and dissection, extending the use of whole-embryo culture to functional analysis by performing in vivo pharmacological manipulations. This experimental accessibility allowed us to study the relevance of microtubules in axis elongation, using nocodazole and taxol drugs to interfere with microtubule networks, followed by length measurement analysis. Additionally, we demonstrated that embryo handling had no effect on the development of Tribolium embryos, and we checked viability after dissection and bisection and during incubation using propidium iodide. The embryo culture protocol we describe here can be applied to study diverse developmental processes in Tribolium. We expect that this protocol can be adapted and applied to other arthropods.

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

    PubMed

    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.

  11. Assessing change in patient-reported quality of life after elective surgery: protocol for an observational comparison study

    PubMed Central

    Kronzer, Vanessa L.; Jerry, Michelle R.; Avidan, Michael S.

    2016-01-01

    Despite their widespread use, the two main methods of assessing quality of life after surgery have never been directly compared. To support patient decision-making and study design, we aim to compare these two methods. The first of these methods is to assess quality of life before surgery and again after surgery using the same validated scale. The second is simply to ask patients whether or not they think their post-operative quality of life is better, worse, or the same. Our primary objective is to assess agreement between the two measures. Secondary objectives are to calculate the minimum clinically important difference (MCID) and to describe the variation across surgical specialties. To accomplish these aims, we will administer surveys to patients undergoing elective surgery, both before surgery and again 30 days after surgery. This protocol follows detailed guidelines for observational study protocols. PMID:27635222

  12. A Case Study of Internet Protocol Telephony (IPT) Implementation at United States Coast Guard Headquarters

    DTIC Science & Technology

    2005-03-01

    enhanced feature sets through the use of IPT. The Coast Guard has an interest in exploiting this technology, and has taken its first steps by...cost savings and enhanced feature sets through the use of IPT. The Coast Guard has an interest in exploiting this technology, and has taken its...Service Level Agreement SRTP Secure Real-time Transport Protocol SS7 Signaling System 7 SSH Secure Shell SSP Service Switching Point STP

  13. Understanding integrated care pathways in palliative care using realist evaluation: a mixed methods study protocol

    PubMed Central

    Jones, Diana; Lhussier, Monique; Cunningham, Bill

    2012-01-01

    Introduction Policy- and evidence-based guidelines have highlighted the need for improved palliative and end-of-life care. However, there is still evidence of individuals dying undignified deaths with little pain control, therefore inflicting unnecessary suffering. New commissioning powers have enabled a 2-year pilot of an innovative integrated care pathway (ICP) designed to improve arrangements for individuals with life-limiting illnesses requiring palliative care. A novel feature of the ICP is its focus on palliative care over the last 6 months of life, aiming to intervene early to prepare for and ensure a good death. What is not known is if this pathway works, how it works and who it works for. Methods and analysis A realist evaluation and a complex analytical framework will investigate and discover context, mechanism and outcome conjectures and configurations of the ICP and thus facilitate exploration of how it works and who it works for. A mixed methods approach will be used with small sample sizes to capture the breadth of the ICP. Phase 1 will identify if the pathway works through analysis of NHS Morbidity Information Query and Export Syntax data, locality Death Audit data and the Quality of Dying and Death Questionnaire. Phase 2 employs soft systems methodology with data from focus groups with health professionals to identify how the pathway works. Phase 3 uses the Miller Behavioural Style Scale and interviews with palliative care patients and bereaved relatives to analyse communication in palliative care. Ethics and dissemination Ethical approval has been granted from the NHS local ethics committee (REC reference number: 11/NE/0318). Research & Development approval has been gained from four different trusts, and relevant voluntary organisations and the local council have been informed about the research. This protocol illustrates the complexity inherent in evaluating a palliative care ICP. Identification of whether the pathway works, how it works and who

  14. MObile Technology for Improved Family Planning Services (MOTIF): study protocol for a randomised controlled trial

    PubMed Central

    2013-01-01

    Background Providing women with contraceptive methods following abortion is important to reduce repeat abortion rates, yet evidence for effective post-abortion family planning interventions are limited. This protocol outlines the evaluation of a mobile phone-based intervention using voice messages to support post-abortion family planning in Cambodia. Methods/Design A single blind randomised controlled trial of 500 participants. Clients aged 18 or over, attending for abortion at four Marie Stopes International clinics in Cambodia, owning a mobile phone and not wishing to have a child at the current time are randomised to the mobile phone-based intervention or control (standard care) with a 1:1 allocation ratio. The intervention comprises a series of six automated voice messages to remind clients about available family planning methods and provide a conduit for additional support. Clients can respond to message prompts to request a phone call from a counsellor, or alternatively to state they have no problems. Clients requesting to talk to a counsellor, or who do not respond to the message prompts, receive a call from a Marie Stopes International Cambodia counsellor who provides individualised advice and support regarding family planning. The duration of the intervention is 3 months. The control group receive existing standard of care without the additional mobile phone-based support. We hypothesise that the intervention will remind clients about contraceptive methods available, identify problems with side effects early and provide support, and therefore increase use of post-abortion family planning, while reducing discontinuation and unsafe method switching. Participants are assessed at baseline and at 4 months. The primary outcome measure is use of an effective modern contraceptive method at 4 months post abortion. Secondary outcome measures include contraception use, pregnancy and repeat abortion over the 4-month post-abortion period. Risk ratios will be used as

  15. SCISSOR—Spinal Cord Injury Study on Small molecule-derived Rho inhibition: a clinical study protocol

    PubMed Central

    Kopp, Marcel A; Liebscher, Thomas; Watzlawick, Ralf; Martus, Peter; Laufer, Stefan; Blex, Christian; Schindler, Ralf; Jungehulsing, Gerhard J; Knüppel, Sven; Kreutzträger, Martin; Ekkernkamp, Axel; Dirnagl, Ulrich; Strittmatter, Stephen M; Niedeggen, Andreas; Schwab, Jan M

    2016-01-01

    Introduction The approved analgesic and anti-inflammatory drugs ibuprofen and indometacin block the small GTPase RhoA, a key enzyme that impedes axonal sprouting after axonal damage. Inhibition of the Rho pathway in a central nervous system-effective manner requires higher dosages compared with orthodox cyclooxygenase-blocking effects. Preclinical studies on spinal cord injury (SCI) imply improved motor recovery after ibuprofen/indometacin-mediated Rho inhibition. This has been reassessed by a meta-analysis of the underlying experimental evidence, which indicates an overall effect size of 20.2% regarding motor outcome achieved after ibuprofen/indometacin treatment compared with vehicle controls. In addition, ibuprofen/indometacin may also limit sickness behaviour, non-neurogenic systemic inflammatory response syndrome (SIRS), neuropathic pain and heterotopic ossifications after SCI. Consequently, ‘small molecule’-mediated Rho inhibition after acute SCI warrants clinical investigation. Methods and analysis Protocol of an investigator-initiated clinical open-label pilot trial on high-dose ibuprofen treatment after acute traumatic, motor-complete SCI. A sample of n=12 patients will be enrolled in two cohorts treated with 2400 mg/day ibuprofen for 4 or 12 weeks, respectively. The primary safety end point is an occurrence of serious adverse events, primarily gastroduodenal bleedings. Secondary end points are pharmacokinetics, feasibility and preliminary effects on neurological recovery, neuropathic pain and heterotopic ossifications. The primary safety analysis is based on the incidence of severe gastrointestinal bleedings. Additional analyses will be mainly descriptive and casuistic. Ethics and dissemination The clinical trial protocol was approved by the responsible German state Ethics Board, and the Federal Institute for Drugs and Medical Devices. The study complies with the Declaration of Helsinki, the principles of Good Clinical Practice and all further

  16. Salivary cortisol protocol adherence and reliability by socio-demographic features: the Multi-Ethnic Study of Atherosclerosis.

    PubMed

    Hill Golden, Sherita; Sánchez, Brisa N; Desantis, Amy S; Wu, Meihua; Castro, Cecilia; Seeman, Teresa E; Tadros, Sameh; Shrager, Sandi; Diez Roux, Ana V

    2014-05-01

    Collection of salivary cortisol has become increasingly popular in large population-based studies. However, the impact of protocol compliance on day-to-day reliabilities of measures, and the extent to which reliabilities differ systematically according to socio-demographic characteristics, has not been well characterized in large-scale population-based studies to date. Using data on 935 men and women from the Multi-Ethnic Study of Atherosclerosis, we investigated whether sampling protocol compliance differs systematically according to socio-demographic factors and whether compliance was associated with cortisol estimates, as well as whether associations of cortisol with both compliance and socio-demographic characteristics were robust to adjustments for one another. We further assessed the day-to-day reliability for cortisol features and the extent to which reliabilities vary according to socio-demographic factors and sampling protocol compliance. Overall, we found higher compliance among persons with higher levels of income and education. Lower compliance was significantly associated with a less pronounced cortisol awakening response (CAR) but was not associated with any other cortisol features, and adjustment for compliance did not affect associations of socio-demographic characteristics with cortisol. Reliability was higher for area under the curve (AUC) and wake up values than for other features, but generally did not vary according to socio-demographic characteristics, with few exceptions. Our findings regarding intra-class correlation coefficients (ICCs) support prior research indicating that multiple day collection is preferable to single day collection, particularly for CAR and slopes, more so than wakeup and AUC. There were few differences in reliability by socio-demographic characteristics. Thus, it is unlikely that group-specific sampling protocols are warranted.

  17. Monitoring activities of teenagers to comprehend their habits: study protocol for a mixed-methods cohort study

    PubMed Central

    2013-01-01

    Background Efforts to increase physical activity in youth need to consider which activities are most likely to be sustained over time in order to promote lifelong participation in physical activity. The Monitoring Activities of Teenagers to Comprehend their Habits (MATCH) study is a prospective cohort study that uses quantitative and qualitative methods to develop new knowledge on the sustainability of specific physical activities. Methods/design Eight hundred and forty-three grade 5 and 6 students recruited from 17 elementary schools in New Brunswick, Canada, are followed-up three times per year. At each survey cycle, participants complete self-report questionnaires in their classroom under the supervision of trained data collectors. A sub-sample of 24 physically active students is interviewed annually using a semi-structured interview protocol. Parents (or guardians) complete telephone administered questionnaires every two years, and a health and wellness school audit is completed for each school. Discussion MATCH will provide a description of the patterns of participation in specific physical activities in youth, and enable identification of the determinants of maintenance, decline, and uptake of participation in each activity. These data will inform the development of interventions that take into account which activities are the most likely to be maintained and why activities are maintained or dropped. PMID:23849265

  18. Detection and Genotyping of Human Papillomavirus DNA in Formalin-Fixed Paraffin-Embedded Specimens with the HPV Direct Flow CHIP System.

    PubMed

    Herraez-Hernandez, Elsa; Preda, Ovidiu; Alonso, Sonia; Pardo, Rosario Serrano; Olmo, Asuncion

    2013-01-01

    The novel HPV Direct Flow CHIP commercial system for Human Papillomavirus (HPV) genotyping is based on rapid PCR and automatic reverse dot blot hybridization to genotype-specific probes, allowing the detection of 36 HPV genotypes. This study examined the performance of HPV Direct Flow CHIP in formalin-fixed paraffin-embedded (FFPE) samples (n= 99). Each sample was analyzed both by Direct PCR, using crude cell extracts without DNA purification, and by conventional PCR, using purified DNA. Pair-wise analysis of the results demonstrated strong concordance between the results obtained with the two protocols, although a slightly higher rate of multiple infections was detected by conventional PCR. In summary, HPV Direct Flow CHIP achieves effective HPV detection from FFPE samples with both Direct PCR and Conventional PCR protocols.

  19. A preliminary study on the identification of vehicle paint chip based on optical coherence tomography

    NASA Astrophysics Data System (ADS)

    Zhang, Ning; Li, Zhihui; Xu, Xiaojing; Huang, Wei; Xu, Lei; Guo, Jingjing; Xie, Lanchi

    2015-12-01

    Vehicle paint chip is a common evidence that plays a significant role in many criminal cases. This paper introduced a novel imaging technology - optical coherence tomography (OCT), which can realize non-invasive, rapid, high-resolution and cross-sectional imaging for the identification of vehicle paint chips. In this paper, a 1310nm swept-source OCT system was adopted to implement the paint imaging. The results show that, compared with conventional spectroscopy and SEM methods, OCT technology can directly obtain the tomographic images of the paints without slicing. In addition, the optical attenuation properties were analyzed to provide a new feature for separating different paint samples. The OCT technology and traditional methods can be combined to further narrow the scope of investigation, providing a comprehensive means to determine or rule out the suspect vehicles.

  20. Radiation hardness studies of AMS HV-CMOS 350 nm prototype chip HVStripV1

    NASA Astrophysics Data System (ADS)

    Kanisauskas, K.; Affolder, A.; Arndt, K.; Bates, R.; Benoit, M.; Di Bello, F.; Blue, A.; Bortoletto, D.; Buckland, M.; Buttar, C.; Caragiulo, P.; Das, D.; Dopke, J.; Dragone, A.; Ehrler, F.; Fadeyev, V.; Galloway, Z.; Grabas, H.; Gregor, I. M.; Grenier, P.; Grillo, A.; Hiti, B.; Hoeferkamp, M.; Hommels, L. B. A.; Huffman, B. T.; John, J.; Kenney, C.; Kramberger, J.; Liang, Z.; Mandic, I.; Maneuski, D.; Martinez-Mckinney, F.; MacMahon, S.; Meng, L.; Mikuž, M.; Muenstermann, D.; Nickerson, R.; Peric, I.; Phillips, P.; Plackett, R.; Rubbo, F.; Segal, J.; Seidel, S.; Seiden, A.; Shipsey, I.; Song, W.; Staniztki, M.; Su, D.; Tamma, C.; Turchetta, R.; Vigani, L.; Volk, J.; Wang, R.; Warren, M.; Wilson, F.; Worm, S.; Xiu, Q.; Zhang, J.; Zhu, H.

    2017-02-01

    CMOS active pixel sensors are being investigated for their potential use in the ATLAS inner tracker upgrade at the HL-LHC. The new inner tracker will have to handle a significant increase in luminosity while maintaining a sufficient signal-to-noise ratio and pulse shaping times. This paper focuses on the prototype chip "HVStripV1" (manufactured in the AMS HV-CMOS 350nm process) characterization before and after irradiation up to fluence levels expected for the strip region in the HL-LHC environment. The results indicate an increase of depletion region after irradiation for the same bias voltage by a factor of ≈2.4 and ≈2.8 for two active pixels on the test chip. There was also a notable increase in noise levels from 85 e‑ to 386 e‑ and from 75 e‑ to 277 e‑ for the corresponding pixels.

  1. Pain management protocols, peri-operative pain and patient satisfaction after total knee replacement: a multicentre study.

    PubMed

    Chang, C B; Cho, W S

    2012-11-01

    In a prospective multicentre study we investigated variations in pain management used by knee arthroplasty surgeons in order to compare the differences in pain levels among patients undergoing total knee replacements (TKR), and to compare the effectiveness of pain management protocols. The protocols, peri-operative levels of pain and patient satisfaction were investigated in 424 patients who underwent TKR in 14 hospitals. The protocols were highly variable and peri-operative pain levels varied substantially, particularly during the first two post-operative days. Differences in levels of pain were greatest during the night after TKR, when visual analogue scores ranged from 16.9 to 94.3 points. Of the methods of managing pain, the combined use of peri-articular infiltration and nerve blocks provided better pain relief than other methods during the first two post-operative days. Patients managed with peri-articular injection plus nerve block, and epidural analgesia were more likely to have higher satisfaction at two weeks after TKR. This study highlights the need to establish a consistent pain management strategy after TKR.

  2. Femtosecond laser nanoaxotomy lab-on-a-chip for in vivo nerve regeneration studies

    PubMed Central

    Guo, Samuel X.; Bourgeois, Frederic; Chokshi, Trushal; Durr, Nicholas J.; Hilliard, Massimo; Chronis, Nikos; Ben-Yakar, Adela

    2011-01-01

    A thorough understanding of nerve regeneration in Caenorhabditis elegans requires performing femtosecond laser nanoaxotomy while minimally affecting the worm. We present a microfluidic device that fulfills such criteria and can easily be automated to enable high-throughput genetic and pharmacological screenings. Using the ‘nanoaxotomy’ chip, we discovered that axonal regeneration occurs much faster than previously described and surprisingly the distal fragment of the severed axon regrows in the absence of anesthetics. PMID:18408725

  3. A cohort study of the recovery of health and wellbeing following colorectal cancer (CREW study): protocol paper

    PubMed Central

    2012-01-01

    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. PMID:22475242

  4. The COMPlaints After Stroke (COMPAS) study: protocol for a Dutch cohort study on poststroke subjective cognitive complaints

    PubMed Central

    van Rijsbergen, Marielle W A; Mark, Ruth E; de Kort, Paul L M; Sitskoorn, Margriet M

    2013-01-01

    Background Although many studies have assessed poststroke objective cognitive impairment, only a few have evaluated patients’ subjective cognitive complaints (SCC). Although these SCC are found to be common in the early and chronic phases after stroke, knowledge about their risk factors, course over time, differences with healthy controls and their diagnostic relevance is limited. The aim of the COMPlaints After Stroke (COMPAS) study is therefore to determine the possible risk factors, prognosis, time course and predictive value of SCC in the first 2 years after stroke. Methods and design A prospective cohort study is conducted in which patients are compared to non-stroke controls at 3, 6, 12 and 24 months after stroke. Approximately 300 patients are recruited from the stroke units of three hospitals in the Netherlands, while 300 controls are sought among the relatives (spouses excluded) and social networks of participants. A wide range of subjective and objective variables is assessed in both groups using interviews, questionnaires and neuropsychological assessment. The primary outcomes include SCC and objective cognitive impairment, whereas secondary outcomes are quality of life, subjective recovery and daily life functioning. Ethics and dissemination The study is being carried out in agreement with the Declaration of Helsinki and the Medical Research Involving Human Subjects Act. The protocol has been approved by the medical ethics committees of the participating centres and all participants give written informed consent. The results will be published in peer-reviewed journals and disseminated to the medical society and general public. Discussion The COMPAS study is the first to systematically evaluate poststroke SCC in a prospective longitudinal design, taking a wide range of subjective and objective variables into account. The results obtained can be used to accurately inform patients and their families, as well as to develop patient

  5. Simulation study of microstrip line in on-chip THz system

    NASA Astrophysics Data System (ADS)

    Zhang, Cong; Su, Bo; Fan, Ning; Zhang, Cunlin

    2016-11-01

    Waveguides, which can transmit high frequency electromagnetic waves, have a lot of types, such as microstrip line (MSL), coplanar waveguides (CPW), coplanar-strip-line (CPS) and so forth. In the waveguides mentioned above, CPW has the advantages of easy fabrication and superior performance. Meanwhile MSL also has many advantages such as small size, light weight and high spectral resolution, but it also shows a higher attenuation and dispersion compared with the free-space waveguides. So in on-chip terahertz system, CPW and MSL was used as waveguides to transmit terahertz waves and the HFSS software was used to simulate and analyze the transmission characteristics of the MSL and CPW based on the on-chip system researched by University of Leeds (America) and Hiroshima University (Japan). The simulation results show that the scattering parameters of the two waveguides are similar to the known literatures. Meanwhile we also have designed a new structure of MSL which is applicable for our on-chip system.

  6. The effect of standardised implantoplasty protocol on titanium surface roughness: an in-vitro study.

    PubMed

    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.

  7. Diagnostic and Prognostic Biomarkers in the Rational Assessment of Mesothelioma (DIAPHRAGM) study: protocol of a prospective, multicentre, observational study

    PubMed Central

    Tsim, Selina; Kelly, Caroline; Alexander, Laura; McCormick, Carol; Thomson, Fiona; Woodward, Rosie; Foster, John E; Stobo, David B; Paul, Jim; Maskell, Nick A; Chalmers, Anthony; Blyth, Kevin G

    2016-01-01

    Introduction Malignant pleural mesothelioma (MPM) is an asbestos-related cancer, which is difficult to diagnose. Thoracoscopy is frequently required but is not widely available. An accurate, non-invasive diagnostic biomarker would allow early specialist referral, limit diagnostic delays and maximise clinical trial access. Current markers offer insufficient sensitivity and are not routinely used. The SOMAmer proteomic classifier and fibulin-3 have recently demonstrated sensitivity and specificity exceeding 90% in retrospective studies. DIAPHRAGM (Diagnostic and Prognostic Biomarkers in the Rational Assessment of Mesothelioma) is a suitably powered, multicentre, prospective observational study designed to determine whether these markers provide clinically useful diagnostic and prognostic information. Methods and analysis Serum and plasma (for SOMAscan and fibulin-3, respectively) will be collected at presentation, prior to pleural biopsy/pleurodesis, from 83 to 120 patients with MPM, at least 480 patients with non-MPM pleural disease and 109 asbestos-exposed controls. Final numbers of MPM/non-MPM cases will depend on the incidence of MPM in the study population (estimated at 13–20%). Identical sampling and storage protocols will be used in 22 recruiting centres and histological confirmation sought in all cases. Markers will be measured using the SOMAscan proteomic assay (SomaLogic) and a commercially available fibulin-3 ELISA (USCN Life Science). The SE in the estimated sensitivity and specificity will be <5% for each marker and their performance will be compared with serum mesothelin. Blood levels will be compared with paired pleural fluid levels and MPM tumour volume (using MRI) in a nested substudy. The prognostic value of each marker will be assessed and a large bioresource created. Ethics and dissemination The study has been approved by the West of Scotland Research Ethics Committee (Ref: 13/WS/0240). A Trial Management Group meets on a monthly basis. Results

  8. The Combating Obesity in Māori and Pasifika Adolescent School-Children Study: COMPASS Methodology and Study Protocol

    PubMed Central

    Stoner, Lee; Shultz, Sarah P.; Lambrick, Danielle M.; Krebs, Jeremy; Weatherall, Mark; Palmer, Barry R.; Lane, Andrew M.; Kira, Geoff; Witter, Trevor; Williams, Michelle A.

    2013-01-01

    Background: Lifestyle modifications including, physical activity can reduce obesity-related morbidity and subsequent cardiovascular disease in youth. This study will investigate the efficacy of a culturally-sensitive, non-contact, boxing-orientated training program on obesity and related cardio-metabolic conditions in Māori and Pasifika adolescents. Details of the methodological aspects of recruitment, inclusion criteria, randomization, cultural sensitivity, intervention program, assessments, process evaluation, and statistical analyses are described. Methods: This study will be a community based, New Zealand, randomized control trial (RCT). Male and female obese (body mass index >95th percentile) Māori and Pasifika adolescents aged 14-16 years will be recruited and the sample size will be confirmed through a feasibility study. Combating Obesity in Māori and Pasifika Adolescent School-children Study (COMPASS) is a 6-month, theory-based program, conducted 3-times/week in a culturally appropriate setting. Each session includes 40 min boxing-orientated training and 30 min resistance training. Assessments will be made at baseline, 3-months, 6-months, 12-months, and 24-months. Main outcomes include abdominal obesity, endothelial function, and insulin resistance. Other outcomes include arterial stiffness, lipid profile, inflammatory biomarkers, well-being, and aerobic fitness. Control measures include physical activity, sleep behavior, and dietary intake. Results: As a protocol paper there are no specific results to present, our purpose is to share our RCT design with the scientific community. Conclusions: COMPASS will be used to provide direction for exercise prescription policy in at-risk Māori and Pasifika adolescents. PMID:23930168

  9. Assessment of Adverse Events in Protocols, Clinical Study Reports, and Published Papers of Trials of Orlistat: A Document Analysis

    PubMed Central

    Schroll, Jeppe Bennekou; Penninga, Elisabeth I.; Gøtzsche, Peter C.

    2016-01-01

    Background 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. Methods and Findings 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

  10. Electromigration and thermomigration studies in composite high lead and eutectic tin-lead flip chip solder joint

    NASA Astrophysics Data System (ADS)

    Huang, Annie Tzuyu

    The effect of thermomigration and the combination effect of thermomigration and electromigration have been studied in composite SnPb flip chip solder joints. Because Al line on the silicon chip side is the major heat source exerted on flip chip solder joint, temperature gradient across the joint is induced when a long Al line is stressed with high current density. Under a estimated temperature gradient of 1000°C/cm, Sn-rich and Pb-rich phase separation is found to occur. Experimental results have shown that Sn-rich phase accumulates at the hot side and Pb-rich phase accumulates at the cold side after thermomigration. When solder bumps are current high current density, thermomigration was found to accompany electromigration. Not only Pb-rich phase migrated toward the anode side and Sn-rich phase migrated toward the cathode side due to electromigration, Sn-rich phase was found to migrate along the top of solder joint due to thermomigration. It was found that as void propagates along the top of the solder joint, current crowding region shifts with the tip of the void. This created a local hot spot and thus a lateral temperature gradient was induced for thermomigration to occur. To isolate the thermal effect from the current effect, ac stressing at 60 Hz was also utilized. Interestingly, ac seems to have an effect other than thermal effect due to the difference in microstructure evolution between pure thermomigration and ac case after stressing. Further investigation at different frequency is needed to fully understand the effect of ac. Furthermore, analysis was performed to explain the phenomena of phase separation and phase reversal in the solder joint considering a constraint volume within underfill. Both Kirkendall effect and back stress were considered. Finally, detail morphological change after thermomigration and electromigration were investigated. Grain refinement was found to occur at a certain stressing condition. Production of entropy and morphological

  11. Docking studies on DNA-ligand interactions: building and application of a protocol to identify the binding mode.

    PubMed

    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.

  12. Examining the impact of genetic testing for type 2 diabetes on health behaviors: study protocol for a randomized controlled trial

    PubMed Central

    2012-01-01

    Background We describe the study design, procedures, and development of the risk counseling protocol used in a randomized controlled trial to evaluate the impact of genetic testing for diabetes mellitus (DM) on psychological, health behavior, and clinical outcomes. Methods/Design Eligible patients are aged 21 to 65 years with body mass index (BMI) ≥27 kg/m2 and no prior diagnosis of DM. At baseline, conventional DM risk factors are assessed, and blood is drawn for possible genetic testing. Participants are randomized to receive conventional risk counseling for DM with eye disease counseling or with genetic test results. The counseling protocol was pilot tested to identify an acceptable graphical format for conveying risk estimates and match the length of the eye disease to genetic counseling. Risk estimates are presented with a vertical bar graph denoting risk level with colors and descriptors. After receiving either genetic counseling regarding risk for DM or control counseling on eye disease, brief lifestyle counseling for prevention of DM is provided to all participants. Discussion A standardized risk counseling protocol is being used in a randomized trial of 600 participants. Results of this trial will inform policy about whether risk counseling should include genetic counseling. Trial registration ClinicalTrials.gov Identifier NCT01060540 PMID:22852560

  13. The Effect of Different Cleaning Protocols on Post Space: A SEM Study

    PubMed Central

    Lo Giudice, Giuseppe; Lizio, Angelo; Giudice, Roberto Lo; Centofanti, Antonio; Rizzo, Giuseppina; Runci, Michele; Alibrandi, Angela

    2016-01-01

    Aim. Purpose of the present paper is to analyze the efficiency of different post-space irrigation protocols. Methods. 28 single rooted teeth were endodontically treated. After post-space preparation every sample was assigned to one of three experimental groups and to one control group. In each group different irrigation protocols were performed as follows: EDTA (Group A), 37% orthophosphoric acid (Group B), and EDTA + 37% orthophosphoric acid with ultrasounds activation (Group C). In the control group (Group D) the irrigate association was not activated by ultrasounds. Three zones (coronal, middle, and apical) of each sample were analyzed by using Scan Electron Microscopy (SEM) without any metallization procedures. The presence of smear layer on the canal surface was qualitatively evaluated by applying Serafino's score with values included between 0 and 2. Results. The results of the research showed how Group C recorded the better results (0.81 ± 0.72). Group A and Group B showed lower mean scores (1.06 ± 0.69 and 1.08 ± 0.77); Group D showed the lowest mean score of 1.30 ± 0.69. The SEM observation analysis demonstrated how the smear layer presence decreased in the crown-apical direction. Conclusions. The different post-space treatments statistically determine significant differences on the dentinal surfaces cleansing. The absence of ultrasonic activation lowers the cleansing efficacy of endocanalar irrigants, showing sensible differences among each post-space zone. PMID:27766106

  14. A Field-Based Cleaning Protocol for Sampling Devices Used in Life-Detection Studies

    NASA Astrophysics Data System (ADS)

    Eigenbrode, Jennifer; Benning, Liane G.; Maule, Jake; Wainwright, Norm; Steele, Andrew; Amundsen, Hans E. F.

    2009-06-01

    Analytical approaches to extant and extinct life detection involve molecular detection often at trace levels. Thus, removal of biological materials and other organic molecules from the surfaces of devices used for sampling is essential for ascertaining meaningful results. Organic decontamination to levels consistent with null values on life-detection instruments is particularly challenging at remote field locations where Mars analog field investigations are carried out. Here, we present a seven-step, multi-reagent decontamination method that can be applied to sampling devices while in the field. In situ lipopolysaccharide detection via low-level endotoxin assays and molecular detection via gas chromatography-mass spectrometry were used to test the effectiveness of the decontamination protocol for sampling of glacial ice with a coring device and for sampling of sediments with a rover scoop during deployment at Arctic Mars-analog sites in Svalbard, Norway. Our results indicate that the protocols and detection technique sufficiently remove and detect low levels of molecular constituents necessary for life-detection tests.

  15. A minimally invasive technique for decompression of Chiari malformation type I (DECMI study): study protocol for a randomised controlled trial

    PubMed Central

    Hu, Yu; Liu, Jiagang; Chen, Haifeng; Jiang, Shu; Li, Qiang; Fang, Yuan; Gong, Shuhui; Wang, Yuelong; Huang, Siqing

    2015-01-01

    Introduction Chiari malformation type I (CM-I) is a congenital hindbrain anomaly that requires surgical decompression in symptomatic patients. Posterior fossa decompression with duraplasty (PFDD) has been widely practiced in Chiari decompression, but dural opening carries a high risk of surgical complications. A minimally invasive technique, dural splitting decompression (DSD), preserves the inner layer of the dura without dural opening and duraplasty, potentially reducing surgical complications, length of operative time and hospital stay, and cost. If DSD is non-inferior to PFDD in terms of clinical improvement, DSD could be an alternative treatment modality for CM-I. So far, no randomised study of surgical treatment of CM-I has been reported. This study aims to evaluate if DSD is an effective, safe and cost-saving treatment modality for adult CM-I patients, and may provide evidence for using the minimally invasive procedure extensively. Methods and analysis DECMI is a randomised controlled, single-masked, non-inferiority, single centre clinical trial. Participants meeting the criteria will be randomised to the DSD group and the PFDD group in a 1:1 ratio. The primary outcome is the rate of clinical improvement, which is defined as the complete resolution or partial improvement of the presenting symptoms/signs. The secondary outcomes consist of the incidence of syrinx reduction, postoperative morbidity rates, reoperation rate, quality of life (QoL) and healthcare resource utilisation. A total of 160 patients will be included and followed up at 3 and 12 months postoperatively. Ethics and dissemination The study protocol was approved by the Biological and Medical Ethics Committee of West China Hospital. The findings of this trial will be published in a peer-reviewed scientific journal and presented at scientific conferences. Trial registration number ChiCTR-TRC-14004099. PMID:25926152

  16. Study of endothelial cell apoptosis using fluorescence resonance energy transfer (FRET) biosensor cell line with hemodynamic microfluidic chip system.

    PubMed

    Yu, J Q; Liu, X F; Chin, L K; Liu, A Q; Luo, K Q

    2013-07-21

    To better understand how hyperglycemia induces endothelial cell dysfunction under the diabetic conditions, a hemodynamic microfluidic chip system was developed. The system combines a caspase-3-based fluorescence resonance energy transfer (FRET) biosensor cell line which can detect endothelial cell apoptosis in real-time, post-treatment effect and with a limited cell sample, by using a microfluidic chip which can mimic the physiological pulsatile flow profile in the blood vessel. The caspase-3-based FRET biosensor endothelial cell line (HUVEC-C3) can produce a FRET-based sensor protein capable of probing caspase-3 activation. When the endothelial cells undergo apoptosis, the color of the sensor cells changes from green to blue, thus sensing apoptosis. A double-labeling fluorescent technique (yo pro-1 and propidium iodide) was used to validate the findings revealed by the FRET-based caspase sensor. The results show high rates of apoptosis and necrosis of endothelial cells when high glucose concentration was applied in our hemodynamic microfluidic chip combined with an exhaustive pulsatile flow profile. The two apoptosis detection techniques (fluorescent method and FRET biosensor) are comparable; but FRET biosensor offers more advantages such as real-time observation and a convenient operating process to generate more accurate and reliable data. Furthermore, the activation of the FRET biosensor also confirms the endothelial cell apoptosis induced by the abnormal pulsatile shear stress and high glucose concentration is through caspase-3 pathway. A 12% apoptotic rate (nearly a 4-fold increase compared to the static condition) was observed when the endothelial cells were exposed to a high glucose concentration of 20 mM under 2 h exhaustive pulsatile shear stress of 30 dyne cm(-2) and followed with another 10 h normal pulsatile shear stress of 15 dyne cm(-2). Therefore, the most important finding of this study is to develop a novel endothelial cell apoptosis detection

  17. Microfabrication of human organs-on-chips.

    PubMed

    Huh, Dongeun; Kim, Hyun Jung; Fraser, Jacob P; Shea, Daniel E; Khan, Mohammed; Bahinski, Anthony; Hamilton, Geraldine A; Ingber, Donald E

    2013-11-01

    'Organs-on-chips' are microengineered biomimetic systems containing microfluidic channels lined by living human cells, which replicate key functional units of living organs to reconstitute integrated human organ-level pathophysiology in vitro. These microdevices can be used to test efficacy and toxicity of drugs and chemicals, and to create in vitro models of human disease. Thus, they potentially represent low-cost alternatives to conventional animal models for pharmaceutical, chemical and environmental applications. Here we describe a protocol for the fabrication, microengineering and operation of these microfluidic organ-on-chip systems. First, microengineering is used to fabricate a multilayered microfluidic device that contains two parallel elastomeric microchannels separated by a thin porous flexible membrane, along with two full-height, hollow vacuum chambers on either side; this requires ∼3.5 d to complete. To create a 'breathing' lung-on-a-chip that mimics the mechanically active alveolar-capillary interface of the living human lung, human alveolar epithelial cells and microvascular endothelial cells are cultured in the microdevice with physiological flow and cyclic suction applied to the side chambers to reproduce rhythmic breathing movements. We describe how this protocol can be easily adapted to develop other human organ chips, such as a gut-on-a-chip lined by human intestinal epithelial cells that experiences peristalsis-like motions and trickling fluid flow. Also, we discuss experimental techniques that can be used to analyze the cells in these organ-on-chip devices.

  18. An Australian Aboriginal birth cohort: a unique resource for a life course study of an Indigenous population. A study protocol

    PubMed Central

    Sayers, Susan M; Mackerras, Dorothy; Singh, Gurmeet; Bucens, Ingrid; Flynn, Kathryn; Reid, Alison

    2003-01-01

    Background The global rise of Type 2 diabetes and its complications has drawn attention to the burden of non-communicable diseases on populations undergoing epidemiological transition. The life course approach of a birth cohort has the potential to increase our understanding of the development of these chronic diseases. In 1987 we sought to establish an Australian Indigenous birth cohort to be used as a resource for descriptive and analytical studies with particular attention on non-communicable diseases. The focus of this report is the methodology of recruiting and following-up an Aboriginal birth cohort of mobile subjects belonging to diverse cultural and language groups living in a large sparsely populated area in the Top End of the Northern Territory of Australia. Methods A prospective longitudinal study of Aboriginal singletons born at the Royal Darwin Hospital 1987–1990, with second wave cross-sectional follow-up examination of subjects 1998–2001 in over 70 different locations. A multiphase protocol was used to locate and collect data on 686 subjects with different approaches for urban and rural children. Manual chart audits, faxes to remote communities, death registries and a full time subject locator with past experience of Aboriginal communities were all used. Discussion The successful recruitment of 686 Indigenous subjects followed up 14 years later with vital status determined for 95% of subjects and examination of 86% shows an Indigenous birth cohort can be established in an environment with geographic, cultural and climatic challenges. The high rates of recruitment and follow up indicate there were effective strategies of follow-up in a supportive population. PMID:12659639

  19. A comparative study on the results of agonist and antagonist protocols based on serum AMH levels in patients undergoing intracytoplasmic sperm injection

    PubMed Central

    Nikmard, Fatemeh; Aflatoonian, Behrouz; Hosseini, Elham; Aflatoonian, Abbas; Bakhtiyari, Mehrdad; Aflatoonian, Reza

    2016-01-01

    Background: Serum concentrations of antimullerian hormone (AMH) correlate with ovarian response during assisted reproduction treatment (ART) cycles. Objective: This retrospective study attempted to evaluate the selection of ovarian stimulation protocols based on serum AMH levels in patients and its impact on the results of ART. Materials and Methods: Based on AMH levels, the patients with tubal factor infertility were divided in three groups of normal, low and high AMH levels. Oocyte, good embryo number and pregnancy rate in each group were analyzed. Results: Using agonist and antagonist protocols, an increase in serum AMH led to higher number of oocytes and better quality embryos. At all low, normal and high AMH levels, the agonist protocol led to a more significant increase in the number of oocytes than the antagonist protocol (p<0.05). The number of high quality embryos significantly increased by the agonist protocol than antagonist protocol in women with normal AMH levels of 1.3-2.6 ng/ml (p=0.00). Moreover, the results for the number of high quality embryos at AMH ˃2.6 ng/ml was in favor of the antagonist protocol (p=0.00). The results showed the lowest pregnancy rate at AMH ˂1.3 ng/ml. At AMH ˃2.6 ng/ml, there was a significant increase in pregnancy rate through the antagonist protocol (p=0.04). Conclusion: Findings of this study suggested that the ART results are predictable, taking into account the AMH levels. The protocol specific to each patient can be used given the AMH level in each individual. This is because the results of each protocol depend on individual conditions. PMID:28066836

  20. Design and measurement considerations for exercise protocols in human air-pollution inhalation studies

    SciTech Connect

    Horvath, S.M.

    1985-01-01

    The impact on pulmonary functions of exercising at different intensities during pollutant exposures was evaluated. It was apparent that there was considerable variation in exercise protocols. These variations occurred in the magnitude of the exercise load, the duration of the exercise period, and the timing of the exercise during exposure. It was also apparent that ventilation during rest and exercise was not always determined; in many instances ventilation was estimated based on other criteria, such as heart rate. The influence of ambient temperature conditions was frequently not considered. Determinations of pulmonary functions were also made at various time intervals following exercise or subsequent rest periods. All of these factors could result in some degree of misinterpretation of the consequences of pollutant exposure.

  1. [Detection of nosocomial infections: a proposal of a protocol for a prospective study].

    PubMed

    Gallet, E; Le Coutour, X; Turrou, J; Noyer, V; Lechevalier, B; Charbonneau, P; Bazin, C

    1989-05-01

    If meant to be effective, the detection of nosocomial infections demands considering the means that should be used for a daily gathering of necessary complete information. An experiment led in a medical intensive care unit have suggested the elements of such a gathering work. This must be prospective and aimed to relate the frequency, more that the importance of nosocomial infections. It will be carried by a willing and specialized nurse, and will be limited to the necessary warning signs only. As a rule, the information linked to the infection causes will not be looked for. Finally, a special care will be given to ensure a good feedback to the clinician, which is the main purpose of that work. Yet, such an information gathering protocol has to be flexible, and it is even one of its survival conditions regarding the variety of means and requirements inherent of each department.

  2. Separation of carboxylic acids in human serum by isotachophoresis using a commercial field-deployable analytical platform combined with in-house glass microfluidic chips.

    PubMed

    Smejkal, Petr; Breadmore, Michael C; Guijt, Rosanne M; Grym, Jakub; Foret, František; Bek, Fritz; Macka, Mirek

    2012-11-28

    Portable and field deployable analytical instruments are attractive in many fields including medical diagnostics, where point of care and on-site diagnostics systems capable of providing rapid quantitative results have the potential to vastly improve the productivity and the quality of medical care. Isotachophoresis (ITP) is a well known electrophoretic separation technique previously demonstrated as suitable for miniaturization in microfluidic chip format (chip-ITP). In this work, a purpose-designed ITP chip compatible with a commercial end-used targeted microfluidic system was used to study different injection protocols and to evaluate the effect of the length of the separation channel on the analytical performance. The in-house ITP chips were made from Corning glass and compared to the commercial DNA chip for the ITP separation of anions from the hydrodynamic injection of human serum. Using the in-house ITP chip the isotachophoretic step of lactate from human serum was approximately two times longer. The results of this research suggested that microfluidic ITP with indirect fluorescence detection is a viable technique for separation of organic acids in human serum samples, especially when a chip with suitable design is used.

  3. Immobilization of flavan-3-ols onto sensor chips to study their interactions with proteins and pectins by SPR

    NASA Astrophysics Data System (ADS)

    Watrelot, Aude A.; Tran, Dong Tien; Buffeteau, Thierry; Deffieux, Denis; Le Bourvellec, Carine; Quideau, Stéphane; Renard, Catherine M. G. C.

    2016-05-01

    Interactions between plant polyphenols and biomacromolecules such as proteins and pectins have been studied by several methods in solution (e.g. isothermal titration calorimetry, dynamic light scattering, nuclear magnetic resonance and spectrophotometry). Herein, these interactions were investigated in real time by Surface Plasmon Resonance (SPR) analysis after immobilization of flavan-3-ols onto a sensor chip surface. (-)-epicatechin, (+)-catechin and flavan-3-ol oligomers with an average degree of polymerization of 2 and 8 were chemically modified using N-(2-(tritylthio)ethyl)propiolamide in order to introduce a spacer unit onto the catecholic B ring. Modified flavan-3-ols were then immobilized onto a carboxymethylated dextran surface (CM5). Immobilization was validated and further verified by evaluating flavan-3-ol interaction with bovine serum albumin (BSA), poly-L-proline or commercial pectins. BSA was found to have a stronger association with monomeric flavan-3-ols than oligomers. SPR analysis of selected flavan-3-ols immobilized onto CM5 sensor chips showed a stronger association for citrus pectins than apple pectins, regardless of flavan-3-ol degree of polymerization.

  4. Boron neutron capture therapy applied to advanced breast cancers: Engineering simulation and feasibility study of the radiation treatment protocol

    NASA Astrophysics Data System (ADS)

    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

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

    PubMed Central

    2014-01-01

    Background Chronic neck pain (CNP) is a common painful medical condition with a significant socioeconomic impact. In spite of widespread usage, the effectiveness and safety of combined treatments between conventional and complementary alternative medical treatment modalities has not been fully established 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) and non-steroidal anti-inflammatory drugs (NSAIDs) in patients with CNP. Methods/Design This is a randomized, single-blind clinical trial with three parallel arms. Sixty patients between 18 and 65 years of age with non-specific, uncomplicated neck pain lasting for at least three months will be enrolled. Participants will be randomly allocated into the BVA, NSAIDs or combined treatment group. Assessors and statisticians will be blinded to the random allocation. All researchers will receive training to ensure their strict adherence to the study protocol. Patients from the BVA and combined treatment group will be treated with a bee venom increment protocol into predefined acupoints for six sessions over a three week period. BVA intervention is developed through a comprehensive discussion among interdisciplinary spine disorder experts, according to the guidelines of Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA). Patients from the NSAIDs and combined treatment groups will be prescribed loxoprofen (one tablet to be taken orally, three times a day for three weeks). Bothersomeness from CNP measured using a visual analogue scale (VAS) will be the primary outcome assessed at screening, visit two (baseline), four, six, eight (4th week assessment) and nine (8th week assessment) follow-up session. VAS for pain intensity, neck disability index (NDI), quality of life, depressive status and adverse experiences will also be

  6. Development of a Protocol for Epidemiologal Studies of Whole-Body Vibration and Musculoskeletal Disorders of the Lower Back

    NASA Astrophysics Data System (ADS)

    Magnusson, M. L.; Pope, M. H.; Hulshof, C. T. J.; Bovenzi, M.

    1998-08-01

    It seems evident from a large number of studies that there is a positive relationship between exposure to whole body vibration (WBV) and the occurrence of low back pain. There are existing standards for evaluating the human exposure to WBV, which are based on other factors than the effect of musculoskeletal disorders. Several national and international standards also exist for evaluating human exposure to WBV. The exposure limit values or health guidance caution zones included in some of these standards are not or only to a limited extent based on systematic epidemiological investigations. It has not yet been possible to establish a clear exposure-response relationship. There are many confounding or contributing factors which influence the hazards to workers caused by exposure to WBV. Reliable methods for the detection and prevention of injury due to vibration exposure at work, alone or in combination with other risk factors, need to be implemented. The aim of this paper was to design a protocol and a questionnaire for conducting collaborative studies of WBV and musculoskeletal back disorders. The protocol will be tested in a pilot study before it will be used in multi-center studies.

  7. Improving care for victims: a study protocol of the evaluation of a centre for sexual and family violence

    PubMed Central

    Zijlstra, E; LoFoWong, S; Hutschemaekers, G; Lagro-Janssen, A

    2016-01-01

    Introduction Worldwide, sexual and family violence are highly prevalent problems. Victims of sexual and family violence often do not seek formal help in the acute phase. When they do seek help, they encounter a system of scattered care. For this reason, a centre for sexual and family violence was launched in Nijmegen, the Netherlands. The centre provides multidisciplinary care for victims of acute sexual and/or family violence. With the study described in this study protocol, we want to evaluate the implementation process and the reach of the Center for Sexual and Family Violence Nijmegen (CSFVN). Methods and analysis We will conduct a mixed-methods study including quantitative and qualitative methods of data collection and analysis. Data about the implementation process will be obtained via semistructured interviews and focus group discussions. Content analysis will be done in software program Atlas.ti. Analysis of file data will be undertaken to assess the reach of the CSFVN (patient characteristics and characteristics of the care they received). The data will be analysed in SPSS. Ethics and dissemination The Medical Ethics Committee of the Radboud University Nijmegen Medical Center approved the study protocol under file number 2012–1218. Dissemination will be done by submitting scientific articles to academic peer-reviewed journals. We will present the results at relevant international, national and local conferences and meetings. We will send press releases to relevant media. We will share the results with the network of assault centres in the Netherlands. PMID:27619828

  8. A multi-level system quality improvement intervention to reduce racial disparities in hypertension care and control: study protocol

    PubMed Central

    2013-01-01

    Background Racial disparities in blood pressure control have been well documented in the United States. Research suggests that many factors contribute to this disparity, including barriers to care at patient, clinician, healthcare system, and community levels. To date, few interventions aimed at reducing hypertension disparities have addressed factors at all of these levels. This paper describes the design of Project ReD CHiP (Reducing Disparities and Controlling Hypertension in Primary Care), a multi-level system quality improvement project. By intervening on multiple levels, this project aims to reduce disparities in blood pressure control and improve guideline concordant hypertension care. Methods Using a pragmatic trial design, we are implementing three complementary multi-level interventions designed to improve blood pressure measurement, provide patient care management services and offer expanded provider education resources in six primary care clinics in Baltimore, Maryland. We are staggering the introduction of the interventions and will use Statistical Process Control (SPC) charting to determine if there are changes in outcomes at each clinic after implementation of each intervention. The main hypothesis is that each intervention will have an additive effect on improvements in guideline concordant care and reductions in hypertension disparities, but the combination of all three interventions will result in the greatest impact, followed by blood pressure measurement with care management support, blood pressure measurement with provider education, and blood pressure measurement only. This study also examines how organizational functioning and cultural competence affect the success of the interventions. Discussion As a quality improvement project, Project ReD CHiP employs a novel study design that specifically targets multi-level factors known to contribute to hypertension disparities. To facilitate its implementation and improve its sustainability, we have

  9. Secondary cancers among children with acute lymphoblastic leukaemia treated by the Tokyo Children's Cancer Study Group protocols: a retrospective cohort study.

    PubMed

    Ishida, Yasushi; Maeda, Miho; Urayama, Kevin Y; Kiyotani, Chikako; Aoki, Yuki; Kato, Yoko; Goto, Shoko; Sakaguchi, Sachi; Sugita, Kenichi; Tokuyama, Mika; Nakadate, Naoya; Ishii, Eizaburo; Tsuchida, Masahiro; Ohara, Akira

    2014-01-01

    With improvement in survival, it is important to evaluate the impact of treatment on secondary cancers in acute lymphoblastic leukaemia (ALL) survivors. A retrospective cohort study comprising 2918 children diagnosed with ALL and enrolled on Tokyo Children's Cancer Study Group (TCCSG) protocols between 1984 and 2005 was conducted to evaluate the incidence of secondary cancers and associated factors including treatment protocol, cranial irradiation and other characteristics of the primary ALL. Thirty-seven patients developed secondary cancers, including acute myeloid leukaemia (n = 11), myelodysplastic syndrome (n = 5), non-Hodgkin lymphoma (n = 2), brain tumours (n = 13) and other solid carcinomas (n = 6) within a median follow-up duration of 9·5 years. The cumulative incidence of any secondary cancers was 1·0% (95% confidence interval (CI), 0·7-1·4%) at 10 years and 2·4% (95% CI, 1·5-3·7%) at 20 years, respectively. Standardized incidence rate ratio of secondary cancers was 9·3 (95% CI, 6·5-12·8). Multivariate analyses showed an increased risk of secondary cancers associated with the recent treatment protocol and cranial irradiation. There was no evidence of a reduction in secondary cancer incidence despite marked decreases in cranial irradiation use in the recent protocols.

  10. Surface Roughness Study on Microchannels of CO2 Laser Fabricating Pmma-Based Microfluidic Chip

    NASA Astrophysics Data System (ADS)

    Chen, Xueye; Li, Tiechuan; Fu, Baoding

    A novel method named soak sacrificial layer ultrasonic method (SSLUM) has been presented for optimizing the surface roughness of the microchannels of polymethyl methacrylate (PMMA)-based microfluidic chips. CO2 laser was used for ablative microchannels on the PMMA sheet, and the effects of key parameters including laser power, laser ablation speed and solution concentration on the surface roughness of microchannels were estimated and optimized by SSLUM. The experimental observation demonstrates that the surface roughness results mainly from the residues on the channel wall, which are produced by the bubbles movement and bursting. The research results show that the surface roughness can be improved effectively by using SSLUM. In our experiment, the best value was Ra = 110nm with laser power 12W, laser ablation speed 10mm/s, the solution concentration 75%, and the time of ultrasonic vibration 25min. SSLUM is proven to be an effective, simple and rapid method for optimizing the surface roughness of microchannels of microfluidic chips.

  11. A protocol for the development of Mediterranean climate services based on the experiences of the CLIM-RUN case studies

    NASA Astrophysics Data System (ADS)

    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.

  12. Quantifying Habitual Levels of Physical Activity According to Impact in Older People: Accelerometry Protocol for the VIBE Study

    PubMed Central

    Deere, Kevin C.; Hannam, Kimberly; Coulson, Jessica; Ireland, Alex; McPhee, Jamie S.; Moss, Charlotte; Edwards, Mark H.; Dennison, Elaine; Cooper, Cyrus; Sayers, Adrian; Lipperts, Matthijs; Grimm, Bernd; Tobias, Jon H.

    2016-01-01

    Physical activity (PA) may need to produce high impacts to be osteogenic. The aim of this study was to identify threshold(s) for defining high impact PA for future analyses in the VIBE (Vertical Impact and Bone in the Elderly) study, based on home recordings with triaxial accelerometers. Recordings were obtained from 19 Master Athlete Cohort (MAC; mean 67.6 years) and 15 Hertfordshire Cohort Study (HCS; mean 77.7 years) participants. Data cleaning protocols were developed to exclude artifacts. Accelerations expressed in g units were categorized into three bands selected from the distribution of positive Y-axis peak accelerations. Data were available for 6.6 and 4.4 days from MAC and HCS participants respectively, with approximately 14 hr recording daily. Three-fold more 0.5–1.0g impacts were observed in MAC versus HCS, 20-fold more 1.0–1.5g impacts, and 140-fold more impacts ≥ 1.5g. Our analysis protocol successfully distinguishes PA levels in active and sedentary older individuals. PMID:26372670

  13. [Study protocol on the effect of the economic crisis on mortality and reproductive health and health inequalities in Spain].

    PubMed

    Pérez, Glòria; Gotsens, Mercè; Palència, Laia; Marí-Dell'Olmo, Marc; Domínguez-Berjón, M Felicitas; Rodríguez-Sanz, Maica; Puig, Vanessa; Bartoll, Xavier; Gandarillas, Ana; Martín, Unai; Bacigalupe, Amaia; Díez, Elia; Ruiz, Miguel; Esnaola, Santiago; Calvo, Montserrat; Sánchez, Pablo; Luque Fernández, Miguel Ángel; Borrell, Carme

    The aim is to present the protocol of the two sub-studies on the effect of the economic crisis on mortality and reproductive health and health inequalities in Spain. Substudy 1: describe the evolution of mortality and reproductive health between 1990 and 2013 through a longitudinal ecological study in the Autonomous Communities. This study will identify changes caused by the economic crisis in trends or reproductive health and mortality indicators using panel data (17 Autonomous Communities per study year) and adjusting Poisson models with random effects variance. Substudy 2: analyse inequalities by socioeconomic deprivation in mortality and reproductive health in several areas of Spain. An ecological study analysing trends in the pre-crisis (1999-2003 and 2004-2008) and crisis (2009-2013) periods will be performed. Random effects models Besag York and Mollié will be adjusted to estimate mortality indicators softened in reproductive health and census tracts.

  14. A pilot study of digital camera resolution metrology protocols proposed under ISO 12233, edition 2

    NASA Astrophysics Data System (ADS)

    Williams, Don; Wueller, Dietmar; Matherson, Kevin; Yoshida, Hideaka; Hubel, Paul

    2008-01-01

    Edition 2 of ISO 12233, Resolution and Spatial Frequency Response (SFR) for Electronic Still Picture Imaging, is likely to offer a choice of techniques for determining spatial resolution for digital cameras different from the initial standard. These choices include 1) the existing slanted-edge gradient SFR protocols but with low contrast features, 2) polar coordinate sine wave SFR technique using a Siemens star element, and 3) visual resolution threshold criteria using a continuous linear spatial frequency bar pattern features. A comparison of these methods will be provided. To establish the level of consistency between the results of these methods, theoretical and laboratory experiments were performed by members of ISO TC42/WG18 committee. Test captures were performed on several consumer and SLR digital cameras using the on-board image processing pipelines. All captures were done in a single session using the same lighting conditions and camera operator. Generally, there was good conformance between methods albeit with some notable differences. Speculation on the reason for these differences and how this can be diagnostic in digital camera evaluation will be offered.

  15. Simplified point-of-care ultrasound protocol to confirm central venous catheter placement: A prospective study

    PubMed Central

    Wilson, Sean P.; Assaf, Samer; Lahham, Shadi; Subeh, Mohammad; Chiem, Alan; Anderson, Craig; Shwe, Samantha; Nguyen, Ryan; Fox, John C.

    2017-01-01

    BACKGROUND: The current standard for confirmation of correct supra-diaphragmatic central venous catheter (CVC) placement is with plain film chest radiography (CXR). We hypothesized that a simple point-of-care ultrasound (POCUS) protocol could effectively confirm placement and reduce time to confirmation. METHODS: We prospectively enrolled a convenience sample of patients in the emergency department and intensive care unit who required CVC placement. Correct positioning was considered if turbulent flow was visualized in the right atrium on sub-xiphoid, parasternal or apical cardiac ultrasound after injecting 5 cc of sterile, non-agitated, normal saline through the CVC. RESULTS: Seventy-eight patients were enrolled. POCUS had a sensitivity of 86.8% (95%CI 77.1%–93.5%) and specificity of 100% (95%CI 15.8%–100.0%) for identifying correct central venous catheter placement. Median POCUS and CXR completion were 16 minutes (IQR 10–29) and 32 minutes (IQR 19–45), respectively. CONCLUSION: Ultrasound may be an effective tool to confirm central venous catheter placement in instances where there is a delay in obtaining a confirmatory CXR. PMID:28123616

  16. Comparative Clinical Study of Two Tooth Bleaching Protocols with 6% Hydrogen Peroxide

    PubMed Central

    Oteo Calatayud, Jesús; Mateos de la Varga, Paloma; Oteo Calatayud, Carlos; Calvo Box, María José

    2009-01-01

    Objective. The objective was to compare the clinical efficacy of two different tooth bleaching protocols after 1 and 2 weeks of treatment with an over-the-counter paint-on gel containing 6% hydrogen peroxide. Material and methods. Sixteen volunteer patients (minimum shade A2 or darker on maxillary teeth) were selected to participate in this randomized, single-blind (examiner-blinded), single-center, 2-group clinical trial using a divided mouth model. The product was applied in our clinic to one hemi-arch (Group I) in each patient at two sessions one week apart, making five applications at each session (separated by 10 min intervals). The patients themselves applied the product once a day for 10 days in the other hemiarch (Group II). Efficacy was measured according to the Vita Classical shade guide at baseline and at one and two weeks. Differences between groups (office-treated vs. home-treated hemiarches) were tested by repeated-measures analysis of variance. Results. Significant (P < .05) differences in shade values were detected between pre- and post-bleaching in both groups. The two groups did not significantly differ in tooth shade at the end of the treatment. Conclusions. Treatment with 6% hydrogen peroxide gel using the paint-on system shows significant clinical efficacy whether applied by clinicians or by the patients themselves. PMID:20339457

  17. A study of topologies and protocols for fiber optic local area network

    NASA Technical Reports Server (NTRS)

    Yeh, C.; Gerla, M.; Rodrigues, P.

    1985-01-01

    The emergence of new applications requiring high data traffic necessitates the development of high speed local area networks. Optical fiber is selected as the transmission medium due to its inherent advantages over other possible media and the dual optical bus architecture is shown to be the most suitable topology. Asynchronous access protocols, including token, random, hybrid random/token, and virtual token schemes, are developed and analyzed. Exact expressions for insertion delay and utilization at light and heavy load are derived, and intermediate load behavior is investigated by simulation. A new tokenless adaptive scheme whose control depends only on the detection of activity on the channel is shown to outperform round-robin schemes under uneven loads and multipacket traffic and to perform optimally at light load. An approximate solution to the queueing delay for an oscillating polling scheme under chaining is obtained and results are compared with simulation. Solutions to the problem of building systems with a large number of stations are presented, including maximization of the number of optical couplers, and the use of passive star/bus topologies, bridges and gateways.

  18. Building America Case Study: Philadelphia Housing Authority Energy-Efficiency Turnover Protocols, Philadelphia, Pennsylvania

    SciTech Connect

    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.

  19. COGNITIVE-HD study: protocol of an observational study of neurocognitive functioning and association with clinical outcomes in adults with end-stage kidney disease treated with haemodialysis

    PubMed Central

    Palmer, Suetonia C; Ruospo, Marinella; Barulli, Maria Rosaria; Iurillo, Annalisa; Saglimbene, Valeria; Natale, Patrizia; Gargano, Letizia; Murgo, Angelo M; Loy, Clement; van Zwieten, Anita; Wong, Germaine; Tortelli, Rosanna; Craig, Jonathan C; Johnson, David W; Tonelli, Marcello; Hegbrant, Jörgen; Wollheim, Charlotta; Logroscino, Giancarlo; Strippoli, G F M

    2015-01-01

    Introduction The prevalence of cognitive impairment may be increased in adults with end-stage kidney disease compared with the general population. However, the specific patterns of cognitive impairment and association of cognitive dysfunction with activities of daily living and clinical outcomes (including withdrawal from treatment) among haemodialysis patients remain incompletely understood. The COGNITIVE impairment in adults with end-stage kidney disease treated with HemoDialysis (COGNITIVE-HD) study aims to characterise the age-adjusted and education-adjusted patterns of cognitive impairment (using comprehensive testing for executive function, perceptual-motor function, language, learning and memory, and complex attention) in patients on haemodialysis and association with clinical outcomes. Methods and analysis A prospective, longitudinal, cohort study of 750 adults with end-stage kidney disease treated with long-term haemodialysis has been recruited within haemodialysis centres in Italy (July 2013 to April 2014). Testing for neurocognitive function was carried out by a trained psychologist at baseline to assess cognitive functioning. The primary study factor is cognitive impairment and secondary study factors will be specific domains of cognitive function. The primary outcome will be total mortality. Secondary outcomes will be cause-specific mortality, major cardiovascular events, fatal and non-fatal myocardial infarction and stroke, institutionalisation, and withdrawal from treatment at 12 months. Ethics and dissemination This protocol was approved before study conduct by the following responsible ethics committees: Catania (approval reference 186/BE; 26/09/2013), Agrigento (protocol numbers 61–62; 28/6/2013), USL Roma C (CE 39217; 24/6/2013), USL Roma F (protocol number 0041708; 23/7/2013), USL Latina (protocol number 20090/A001/2011; 12/7/2013), Trapani (protocol number 3413; 16/7/2013) and Brindisi (protocol number 40259; 6/6/2013). All participants

  20. Discrete component bonding and thick film materials study. [of capacitor chips bonded with solders and conductive epoxies

    NASA Technical Reports Server (NTRS)

    Kinser, D. L.

    1976-01-01

    The bonding reliability of discrete capacitor chips bonded with solders and conductive epoxies was examined along with the thick film resistor materials consisting of iron oxide phosphate and vanadium oxide phosphates. It was concluded from the bonding reliability studies that none of the wide range of types of solders examined is capable of resisting failure during thermal cycling while the conductive epoxy gives substantially lower failure rates. The thick film resistor studies proved the feasibility of iron oxide phosphate resistor systems although some environmental sensitivity problems remain. One of these resistor compositions has inadvertently proven to be a candidate for thermistor applications because of the excellent control achieved upon the temperature coefficient of resistance. One new and potentially damaging phenomenon observed was the degradation of thick film conductors during the course of thermal cycling.

  1. Toward on-chip functional neuronal networks: computational study on the effect of synaptic connectivity on neural activity.

    PubMed

    Foroushani, Armin Najarpour; Ghafar-Zadeh, Ebrahim

    2014-01-01

    This paper presents a new unified computational-experimental approach to study the role of the synaptic activity on the activity of neurons in the small neuronal networks (NNs). In a neuronal tissue/organ, this question is investigated with higher complexities by recording action potentials from population of neurons in order to find the relationship between connectivity and the recorded activities. In this approach, we study the dynamics of very small cortical neuronal networks, which can be experimentally synthesized on chip with constrained connectivity. Multi-compartmental Hodgkin-Huxley model is used in NEURON software to reproduce cells by extracting the experimental data from the synthesized NNs. We thereafter demonstrate how the type of synaptic activity affects the network response to specific spike train using the simulation results.

  2. Validation study for using lab-on-chip technology for Coxiella burnetii multi-locus-VNTR-analysis (MLVA) typing: application for studying genotypic diversity of strains from domestic ruminants in France.

    PubMed

    Prigent, Myriam; Rousset, Elodie; Yang, Elise; Thiéry, Richard; Sidi-Boumedine, Karim

    2015-01-01

    Coxiella burnetii, the etiologic bacterium of Q fever zoonosis, is still difficult to control. Ruminants are often carriers and involved in human epidemics. MLVA is a promising genotyping method for molecular epidemiology. Different techniques are used to resolve the MLVA band profiles such as electrophoresis on agarose gels, capillary electrophoresis or using the microfluidic Lab-on-Chip system. In this study, system based on microfluidics electrophoresis with Lab-on-Chip technology was assessed and applied on DNA field samples to investigate the genotypic diversity of C. burnetii strains circulating in France. The Lab-on-Chip technology was first compared to agarose gel electrophoresis. Subsequently, the set-up Lab-on-Chip technology was applied on 97 samples collected from ruminants in France using the 17 markers previously described. A discordance rate of 27% was observed between Lab-on-Chip and agarose gel electrophoresis. These discrepancies were checked and resolved by sequencing. The cluster analysis revealed classification based on host species and/or geographic origin criteria. Moreover, the circulation of different genotypic strains within the same farm was also observed. In this study, MLVA with Lab-on-Chip technology was shown to be more accurate, reproducible, user friendly and safer than gel electrophoresis. It also provides an extended data set from French ruminant C. burnetii circulating strains useful for epidemiological investigations. Finally, it raises some questions regarding the standardization and harmonization of C. burnetii MLVA genotyping.

  3. A novel protocol for gastric lavage in patients with aluminum phosphide poisoning: a double-blind study.

    PubMed

    Mostafazadeh, Babak; Farzaneh, Esmaeil

    2012-01-01

    Aluminum phosphide poisoning (ALPP) still has no efficient and approved antidote. Supportive care and hemodynamic monitoring are the only choices of treatment. We proposed a new lavage formulation in addition to evaluation of its efficacy and defining the impact of clinical characteristics of patients on their prognosis. During eight months period of time, 120 patients were enrolled to the study and randomly received two different gastric lavage protocols. Our new lavage protocol had positive impact on patients' survival and the P-value in comparison with the classic gastric lavage method was close to significant level (P=0.054). On hospital arrival indication for intubation-ventilation as well as sense of thirst, sore throat and absence of nausea indicate worse outcome. Using our novel approach, indication for intubation-ventilation as well as sense of thirst, sore throat and absence of nausea can be considered as applicable prognostic factors in survival of ALPP patients. Further studies are required to set this approach as preferred treatment.

  4. Designing isothermal titration calorimetry experiments for the study of 1:1 binding: problems with the "standard protocol".

    PubMed

    Tellinghuisen, Joel

    2012-05-15

    Literature recommendations for designing isothermal titration calorimetry (ITC) experiments to study 1:1 binding, M+X -->/<-- MX, are not consistent and have persisted through time with little quantitative justification. In particular, the "standard protocol" employed by most workers involves 20 to 30 injections of titrant to a final titrant/titrand mole ratio (R(m)) of ~ 2-a scheme that can be far from optimal and can needlessly limit applicability of the ITC technique. These deficiencies are discussed here along with other misconceptions. Whether a specific binding process can be studied by ITC is determined less by c (the product of binding constant K and titrand concentration [M](0)) than by the total detectable heat q(tot) and the extent to which M can be converted to MX. As guidelines, with 90% conversion to MX, K can be estimated within 5% over the range 10 to 10(8)M(-1) when q(tot)/σ(q)≈700, where σ(q) is the standard deviation for estimation of q. This ratio drops to ~150 when the stoichiometry parameter n is treated as known. A computer application for modeling 1:1 binding yields realistic estimates of parameter standard errors for use in protocol design and feasibility assessment.

  5. A randomised controlled trial of acceptance and commitment therapy (ACT) for psychosis: study protocol

    PubMed Central

    2014-01-01

    Background 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. Methods/Design 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. Discussion This protocol describes the first randomised controlled trial of Acceptance and commitment therapy in

  6. Computerised cognitive behaviour therapy for depression in adolescents: study protocol for a feasibility randomised controlled trial

    PubMed Central

    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

    2014-01-01

    dissemination The current trial protocol received a favourable ethical opinion from Leeds (West) Research and Ethics Committee. (Reference: 10/H1307/137). Trial registration number ISRCTN31219579. PMID:25361841

  7. Study of individual erythrocyte deformability susceptibility to INFeD and ethanol using a microfluidic chip

    PubMed Central

    Liu, Lihong; Huang, Sha; Xu, Xiaoying; Han, Jongyoon

    2016-01-01

    Human red blood cells (RBCs) deformability in vitro was assessed during iron dextran (INFeD) loading and/or ethanol co-administration using microfluidic deformability screening. The results showed donor-specific variations in dose dependent deformability shift were revealed below 500 μg/mL iron dextran. Two out of nine blood samples exhibited significant cell stiffening at 500 μg/mL iron dextran loading concentration (p < 0.05, Tukey test). More interestingly, co-administration of moderate amount of ethanol was identified to have significant protective effects on RBC deformability. We also noted that ethanol can reverse the deformability of impaired RBCs. Meanwhile obvious donor dependent response to ethanol administration on RBC deformability was noted using our biomimetic microfluidic chip. PMID:26964754

  8. ImmunoChip study implicates antigen presentation to T cells in narcolepsy.

    PubMed

    Faraco, Juliette; Lin, Ling; Kornum, Birgitte Rahbek; Kenny, Eimear E; Trynka, Gosia; Einen, Mali; Rico, Tom J; Lichtner, Peter; Dauvilliers, Yves; Arnulf, Isabelle; Lecendreux, Michel; Javidi, Sirous; Geisler, Peter; Mayer, Geert; Pizza, Fabio; Poli, Francesca; Plazzi, Giuseppe; Overeem, Sebastiaan; Lammers, Gert Jan; Kemlink, David; Sonka, Karel; Nevsimalova, Sona; Rouleau, Guy; Desautels, Alex; Montplaisir, Jacques; Frauscher, Birgit; Ehrmann, Laura; Högl, Birgit; Jennum, Poul; Bourgin, Patrice; Peraita-Adrados, Rosa; Iranzo, Alex; Bassetti, Claudio; Chen, Wei-Min; Concannon, Patrick; Thompson, Susan D; Damotte, Vincent; Fontaine, Bertrand; Breban, Maxime; Gieger, Christian; Klopp, Norman; Deloukas, Panos; Wijmenga, Cisca; Hallmayer, Joachim; Onengut-Gumuscu, Suna; Rich, Stephen S; Winkelmann, Juliane; Mignot, Emmanuel

    2013-01-01

    Recent advances in the identification of susceptibility genes and environmental exposures provide broad support for a post-infectious autoimmune basis for narcolepsy/hypocretin (orexin) deficiency. We genotyped loci associated with other autoimmune and inflammatory diseases in 1,886 individuals with hypocretin-deficient narcolepsy and 10,421 controls, all of European ancestry, using a custom genotyping array (ImmunoChip). Three loci located outside the Human Leukocyte Antigen (HLA) region on chromosome 6 were significantly associated with disease risk. In addition to a strong signal in the T cell receptor alpha (TRA@), variants in two additional narcolepsy loci, Cathepsin H (CTSH) and Tumor necrosis factor (ligand) superfamily member 4 (TNFSF4, also called OX40L), attained genome-wide significance. These findings underline the importance of antigen presentation by HLA Class II to T cells in the pathophysiology of this autoimmune disease.

  9. Comparative Evaluation of Stroke Triage Algorithms for Emergency Medical Dispatchers (MeDS): Prospective Cohort Study Protocol

    PubMed Central

    2011-01-01

    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 between the two groups

  10. HuMiChip: Development of a Functional Gene Array for the Study of Human Microbiomes

    SciTech Connect

    Tu, Q.; Deng, Ye; Lin, Lu; Hemme, Chris L.; He, Zhili; Zhou, Jizhong

    2010-05-17

    Microbiomes play very important roles in terms of nutrition, health and disease by interacting with their hosts. Based on sequence data currently available in public domains, we have developed a functional gene array to monitor both organismal and functional gene profiles of normal microbiota in human and mouse hosts, and such an array is called human and mouse microbiota array, HMM-Chip. First, seed sequences were identified from KEGG databases, and used to construct a seed database (seedDB) containing 136 gene families in 19 metabolic pathways closely related to human and mouse microbiomes. Second, a mother database (motherDB) was constructed with 81 genomes of bacterial strains with 54 from gut and 27 from oral environments, and 16 metagenomes, and used for selection of genes and probe design. Gene prediction was performed by Glimmer3 for bacterial genomes, and by the Metagene program for metagenomes. In total, 228,240 and 801,599 genes were identified for bacterial genomes and metagenomes, respectively. Then the motherDB was searched against the seedDB using the HMMer program, and gene sequences in the motherDB that were highly homologous with seed sequences in the seedDB were used for probe design by the CommOligo software. Different degrees of specific probes, including gene-specific, inclusive and exclusive group-specific probes were selected. All candidate probes were checked against the motherDB and NCBI databases for specificity. Finally, 7,763 probes covering 91.2percent (12,601 out of 13,814) HMMer confirmed sequences from 75 bacterial genomes and 16 metagenomes were selected. This developed HMM-Chip is able to detect the diversity and abundance of functional genes, the gene expression of microbial communities, and potentially, the interactions of microorganisms and their hosts.

  11. Study of Optimal Replacement of Thyroxine in the ElDerly (SORTED): protocol for a mixed methods feasibility study to assess the clinical utility of lower dose thyroxine in elderly hypothyroid patients: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background The population of the UK is ageing. There is compelling evidence that thyroid stimulating hormone distribution levels increase with age. Currently, in UK clinical practice elderly hypothyroid patients are treated with levothyroxine to lower their thyroid stimulating hormone levels to a standard non-age-related range. Evidence suggests that mortality is negatively associated with thyroid stimulating hormone levels. We report the protocol of a feasibility study working towards a full-scale randomized controlled trial to test whether lower dose levothyroxine has beneficial cardiovascular outcomes in the oldest old. Methods/design SORTED is a mixed methods study with three components: SORTED A: A feasibility study of a dual-center single-blinded randomized controlled trial of elderly hypothyroid patients currently treated with levothyroxine. Setting: Patients will be recruited from 20 general practices and two hospital trust endocrine units in Northumberland, Tyne and Wear. Participants: Target recruitment of 50 elderly hypothyroid patients currently treated with levothyroxine, identified in both primary and secondary care settings. Intervention: Reduced dose of levothyroxine to achieve an elevated serum thyroid stimulating hormone (target range 4.1 to 8.0 mU/L) versus standard levothyroxine replacement (target range 0.4 to 4.0 mU/L). Randomization: Using random permuted blocks, in a ratio of 1:1, randomization will be carried out by Newcastle Clinical Trials Unit. Outcomes: Study feasibility (recruitment and retention rates and medication compliance), acceptability of the trial design, assessment of mobility and falls risk, and change in cardiovascular risk factors. SORTED B: Qualitative study using in-depth interviews to understand patients’ willingness to take part in a randomized controlled trial and participants’ experience of the intervention. SORTED C: Retrospective cohort study of 400 treated hypothyroid patients aged 80 years or over

  12. A study on the development of the protocol of leisure activity program for the elderly's deviant prevention.

    PubMed

    Ahn, Chan-Woo; Yi, Eun-Surk; Park, Dong-Kyun; Lee, Hi-Wan; Lee, Kwang-Uk; Min, Byeong-Seok; Cho, Gun-Sang; Chang, Ik-Young

    2014-04-01

    The purpose of this study is to provide planning methods for leisure activity program to prevent the elderly's deviance, using the program components and protocol factors. This section discusses the results obtained through document analysis and Delphi technique. First, the components of leisure activity program were classified into five stages such as definition, condition analysis, program composition, application and evaluation. Second, the protocol factors in each stage of leisure activity program for the elderly's deviant prevention were 19 main themes and 75 sub-themes respectively. In the stage of condition analysis, five main themes such as deviant prediction, individual, socio-demographic, social and cultural factors and 25 sub-themes were found. Program composition included three main themes, facilities, instructor and program and 16 sub-themes and in the application stage, there were three key themes, facilities, instructor and program and 14 sub-themes. Lastly, the evaluation found four main themes such as deviant prevention, participation in leisure activities, management and wellbeing and 16 sub-themes.

  13. A comparative study of the use of the Istanbul Protocol amongst civil society organizations in low-income countries.

    PubMed

    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. Effect of residual chips on the material removal process of the bulk metallic glass studied by in situ scratch testing inside the scanning electron microscope

    SciTech Connect

    Huang Hu; Zhao Hongwei; Shi Chengli; Wu Boda; Fan Zunqiang; Wan Shunguang; Geng Chunyang

    2012-12-15

    Research on material removal mechanism is meaningful for precision and ultra-precision manufacturing. In this paper, a novel scratch device was proposed by integrating the parasitic motion principle linear actuator. The device has a compact structure and it can be installed on the stage of the scanning electron microscope (SEM) to carry out in situ scratch testing. Effect of residual chips on the material removal process of the bulk metallic glass (BMG) was studied by in situ scratch testing inside the SEM. The whole removal process of the BMG during the scratch was captured in real time. Formation and growth of lamellar chips on the rake face of the Cube-Corner indenter were observed dynamically. Experimental results indicate that when lots of chips are accumulated on the rake face of the indenter and obstruct forward flow of materials, materials will flow laterally and downward to find new location and direction for formation of new chips. Due to similar material removal processes, in situ scratch testing is potential to be a powerful research tool for studying material removal mechanism of single point diamond turning, single grit grinding, mechanical polishing and grating fabrication.

  15. The Agricultural Model Intercomparison and Improvement Project (AgMIP): Protocols and Pilot Studies

    NASA Technical Reports Server (NTRS)

    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.; Asseng, S.; Basso, B.; Ewert, F.; Wallach, D.; Baigorria, G.; Winter, J. M.

    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

  16. Mindfulness-based intervention for teenagers with cancer: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Individuals living with cancer must learn to face not only the physical symptoms of their condition, but also the anxiety and uncertainty related to the progression of the disease, the anticipation of physical and emotional pain related to illness and treatment, the significant changes implied in living with cancer, as well as the fear of recurrence after remission. Mindfulness-based meditation constitutes a promising option to alleviate these manifestations. Methods/Design This article presents the rationale and protocol development for a research project aimed at evaluating the effects of a mindfulness-based meditation intervention on quality of life, sleep, and mood in adolescents with cancer compared to a control group. A prospective, longitudinal, experimental design involving three time points (baseline, post-intervention, and follow-up) and two groups (experimental and control) was developed for this project. Participants will be assigned randomly to either group. Eligible participants are adolescents aged 11 to 18 years with a diagnosis of cancer, with no specific selection/exclusion based on type, stage, or trajectory of cancer. A final sample size of 28 participants is targeted. Adolescents in the experimental group will be completing the mindfulness meditation intervention, taught by two trained therapists. The intervention will comprise of eight weekly sessions, lasting 90 min each. Once the follow-up assessment is completed by the experimental group, wait-list controls will be offered to complete the mindfulness-based program. Intra-group analyses will serve to evaluate the impact of the mindfulness-based meditation intervention on quality of life, sleep, and mood pre-post intervention, as well as follow-up. Analyses will also be used to carry out inter-group comparisons between the experimental group and the wait-list controls. Voluntary participation, risk of attrition, and the small sample size are potential limitations of this project

  17. HEART: heart exercise and remote technologies: A randomized controlled trial study protocol

    PubMed Central

    2011-01-01

    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 information about physical and

  18. Agreements between Industry and Academia on Publication Rights: A Retrospective Study of Protocols and Publications of Randomized Clinical Trials

    PubMed Central

    Kasenda, Benjamin; von Elm, Erik; You, John J.; 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.; Nordmann, Alain; Gloy, Viktoria; Ebrahim, Shanil; Schandelmaier, Stefan; Sun, Xin; Vandvik, Per O.; Johnston, Bradley C.; Walter, Martin A.; Burnand, Bernard; Hemkens, Lars G.; Bucher, Heiner C.; Guyatt, Gordon H.; Briel, Matthias

    2016-01-01

    Background 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. Methods and Findings 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. Conclusions Publication agreements constraining academic authors’ independence are common. Journal articles seldom report on

  19. Effectiveness of phototherapy incorporated into an exercise program for osteoarthritis of the knee: study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Osteoarthritis is a chronic disease with a multifactor etiology involving changes in bone alignment, cartilage, and other structures necessary to joint stability. There is a need to investigate therapeutic resources that combine different wavelengths as well as different light sources (low-level laser therapy and light-emitting diode therapy) in the same apparatus for the treatment of osteoarthritis. The aim of the proposed study is to analyze the effect of the incorporation of phototherapy into a therapeutic exercise program for individuals with osteoarthritis of the knee. Methods/Design A double-blind, controlled, randomized clinical trial will be conducted involving patients with osteoarthritis of the knee. Evaluations will be performed using functional questionnaires before and after the treatment protocols, in a reserved room with only the evaluator and participant present, and no time constraints placed on the answers or evaluations. The following functional tests will also be performed: stabilometry (balance assessment), dynamometry (muscle strength of gluteus medius and quadriceps), algometry (pain threshold), fleximeter (range of motion), timed up-and-go test (functional mobility), and the functional reach test. The participants will then be allocated to three groups through a randomization process using opaque envelopes: exercise program, exercise program + phototherapy, or exercise program + placebo phototherapy, all of which will last for eight weeks. Discussion The purpose of this randomized clinical trial is to analyze the effect of the incorporation of phototherapy into a therapeutic exercise program for osteoarthritis of the knee. The study will support the practice based on evidence to the use of phototherapy in individuals with a diagnosis of osteoarthritis of the knee. Data will be published after the study is completed. Trial registration The protocol for this study has been submitted to Clinical Trials, registration number

  20. The Korean Gastric Cancer Cohort Study: Study Protocol and Brief Results of a Large-Scale Prospective Cohort Study

    PubMed Central

    Eom, Bang Wool; Kim, Young-Woo; Nam, Byung-Ho; Ryu, Keun Won; Jeong, Hyun-Yong; Park, Young-Kyu; Lee, Young-Joon; Yang, Han-Kwang; Yu, Wansik; Yook, Jeong-Hwan; Song, Geun Am; Youn, Sei-Jin; Kim, Heung Up; Noh, Sung-Hoon; Park, Sung Bae; Yang, Doo-Hyun; Kim, Sung

    2016-01-01

    Purpose This study aimed to establish a large-scale database of patients with gastric cancer to facilitate the development of a national-cancer management system and a comprehensive cancer control policy. Materials and Methods An observational prospective cohort study on gastric cancer was initiated in 2010. A total of 14 cancer centers throughout the country and 152 researchers were involved in this study. Patient enrollment began in January 2011, and data regarding clinicopathological characteristics, life style-related factors, quality of life, as well as diet diaries were collected. Results In total, 4,963 patients were enrolled until December 2014, and approximately 5% of all Korean patients with gastric cancer annually were included. The mean age was 58.2±11.5 years, and 68.2% were men. The number of patients in each stage was as follows: 3,394 patients (68.4%) were in stage IA/B; 514 patients (10.4%), in stage IIA/B; 469 patients (9.5%), in stage IIIA/B/C; and 127 patients (2.6%), in stage IV. Surgical treatment was performed in 3,958 patients (79.8%), endoscopic resection was performed in 700 patients (14.1%), and 167 patients (3.4%) received palliative chemotherapy. The response rate for the questionnaire on the quality of life was 95%; however, diet diaries were only collected for 27% of patients. Conclusions To provide comprehensive information on gastric cancer for patients, physicians, and government officials, a large-scale database of Korean patients with gastric cancer was established. Based on the findings of this cohort study, an effective cancer management system and national cancer control policy could be developed. PMID:27752396

  1. Keeping Weight Off: study protocol of an RCT to investigate brain changes associated with mindfulness-based stress reduction

    PubMed Central

    Siegel, Julia A; Allison, Jeroan; Rosal, Milagros C; Brewer, Judson; King, Jean A

    2016-01-01

    Introduction Obesity is a growing epidemic fuelled by unhealthy behaviours and associated with significant comorbidities and financial costs. While behavioural interventions produce clinically meaningful weight loss, weight loss maintenance is challenging. This may partially be due to failure to target stress and emotional reactivity. Mindfulness-based stress reduction (MBSR) reduces stress and emotional reactivity and may be a useful tool for behaviour change maintenance. This study seeks to provide a mechanistic understanding for clinical trials of the benefits of MBSR for weight loss maintenance by examining changes in functional connectivity (FC) and the association of these changes with clinical outcomes. Methods and analysis Community-dwelling individuals (n=80) who intentionally lost ≥5% of their body weight in the past year will be recruited and randomised to an MBSR programme or educational control. FC using resting-state functional MRI will be measured at baseline and 8 weeks. Psychological factors, health behaviours, body mass index and waist circumference will be measured at baseline, 8 weeks and 6 months post intervention. A 12-month telephone follow-up will assess self-reported weight. Analyses will characterise FC changes in response to MBSR in comparison with a control condition, assess the relationship between baseline FC status and pre–post MBSR changes in FC and investigate the association of FC change with changes in psychological factors and weight loss maintenance. Ethics and dissemination The University of Massachusetts Medical School Institutional Review Board has approved this study, Declaration of Helsinki protocols are being followed, and patients will give written informed consent. The Independent Monitoring Committee will monitor protocol adherence. Results from the study will be disseminated to the medical community at conferences and submitted for publication in peer-reviewed journals when the last patient included has been

  2. Nutritional route in oesophageal resection trial II (NUTRIENT II): study protocol for a multicentre open-label randomised controlled trial

    PubMed Central

    Berkelmans, Gijs H K; Wilts, Bas J W; Kouwenhoven, Ewout A; Kumagai, Koshi; Nilsson, Magnus; Weijs, Teus J; Nieuwenhuijzen, Grard A P; van Det, Marc J; Luyer, Misha D P

    2016-01-01

    Introduction Early start of an oral diet is safe and beneficial in most types of gastrointestinal surgery and is a crucial part of fast track or enhanced recovery protocols. However, the feasibility and safety of oral intake directly following oesophagectomy remain unclear. The aim of this study is to investigate the effects of early versus delayed start of oral intake on postoperative recovery following oesophagectomy. Methods and analysis This is an open-label multicentre randomised controlled trial. Patients undergoing elective minimally invasive or hybrid oesophagectomy for cancer are eligible. Further inclusion criteria are intrathoracic anastomosis, written informed consent and age 18 years or older. Inability for oral intake, inability to place a feeding jejunostomy, inability to provide written consent, swallowing disorder, achalasia, Karnofsky Performance Status <80 and malnutrition are exclusion criteria. Patients will be randomised using online randomisation software. The intervention group (direct oral feeding) will receive a liquid oral diet for 2 weeks with gradually expanding daily maximums. The control group (delayed oral feeding) will receive enteral feeding via a jejunostomy during 5 days and then start the same liquid oral diet. The primary outcome measure is functional recovery. Secondary outcome measures are 30-day surgical complications; nutritional status; need for artificial nutrition; need for additional interventions; health-related quality of life. We aim to recruit 148 patients. Statistical analysis will be performed according to an intention to treat principle. Results are presented as risk ratios with corresponding 95% CIs. A two-tailed p<0.05 is considered statistically significant. Ethics and dissemination Our study protocol has received ethical approval from the Medical research Ethics Committees United (MEC-U). This study is conducted according to the principles of Good Clinical Practice. Verbal and written informed consent is

  3. A multidisciplinary intervention to facilitate return to work in cancer patients: intervention protocol and design of a feasibility study

    PubMed Central

    de Boer, Angela G E M; Frings-Dresen, Monique H W

    2012-01-01

    Introduction Returning to work can be problematic for cancer survivors due to suboptimal workplace support, a heavy workload, decreased physical functioning and fatigue. The timely and permanent return to work (RtW) of cancer patients favourably influences quality of life and economic independence. Multidisciplinary interventions aimed at timely and enduring RtW are lacking. The objectives of this article are (1) to describe the protocol of an intervention aimed at RtW of cancer patients, comprising of counselling by an oncological occupational physician and supervised physical exercise in a clinical setting during treatment and (2) to present the design of the study aimed at evaluating the feasibility of this intervention. Methods and analysis The intervention comprises three counselling sessions with an oncological occupational physician and a 12-week moderate-to-high intensity physical exercise programme, starting at the onset of chemotherapy. The intervention is aimed at cancer patients treated with curative intent, aged 18–60 years, employed and on sick leave. It will take place in two large medical centres in the Netherlands. The feasibility of the intervention will be evaluated as follows: the number of sessions, topics discussed and exercises executed will be registered by care providers; patients' and care providers' opinions will be assessed by questionnaires and interviews, respectively; and the proportion of invited patients that participated will be calculated. Ethics and dissemination The study results will be used for optimising the intervention content and may serve as a foundation for future implementation. The Medical Ethics Committees of the Academic Medical Center and the participating medical centres approved the study protocol. PMID:22786950

  4. Mechanics of formation of sawtooth chips

    NASA Astrophysics Data System (ADS)

    Vyas, Amitabh

    Formation of sawtooth chips was studied while machining case carburized 8620 steel (of varying degrees of hardness--upto Rc62), Titanium and Brass. Cutting forces were measured and an attempt was made to measure temperature during machining of case carburized 8620 steel. Conventional tool-chip thermocouple technique was modified to accommodate the effects due to design of Cubic Boron Nitride (CBN) cutting inserts. The chips produced were examined under Optical Microscope, Scanning Electron Microscope and Transmission Electron Microscope. A technique was developed for specimen preparation to study the microstructure of a non-etching white layer under a transmission electron microscope. All the experiments done during this study for an investigation into the root cause of a sawtooth chip formation suggest that a cyclic crack formation on the free surface side of the chip is responsible for the formation of the sawtooth chips; contrary to the widely accepted view of adiabatic shear being the root cause of the sawtooth chip formation. A Quick-Stop device was also used to determine the mechanism of the sawtooth chip formation. A new method of evaluating cutting ratio for the sawtooth chips is proposed and was verified experimentally.

  5. Predictive Factors for Anastomotic Leakage After Colorectal Surgery: Study Protocol for a Prospective Observational Study (REVEAL Study)

    PubMed Central

    Bosmans, Joanna WAM; Kartal, Serdar; Lubbers, Tim; Sosef, Meindert; Slooter, Gerrit D; Stoot, Jan H; van Schooten, Frederik-Jan; Bouvy, Nicole D; Derikx, Joep PM

    2016-01-01

    Background Anastomotic leakage (AL) remains the most important complication following colorectal surgery, and is associated with high morbidity and mortality rates. Previous research has focused on identifying risk factors and potential biomarkers for AL, but the sensitivity of these tests remains poor. Objective This prospective multicenter observational study aims at combining multiple parameters to establish a diagnostic algorithm for colorectal AL. Methods This study aims to include 588 patients undergoing surgery for colorectal carcinoma. Patients will be eligible for inclusion when surgery includes the construction of a colorectal anastomosis. Patient characteristics will be collected upon consented inclusion, and buccal swabs, breath, stool, and blood samples will be obtained prior to surgery. These samples will allow for the collection of information regarding patients’ inflammatory status, genetic predisposition, and intestinal microbiota. Additionally, breath and blood samples will be taken postoperatively and patients will be strictly observed during their in-hospital stay, and the period shortly thereafter. Results This study has been open for inclusion since August 2015. Conclusions An estimated 8-10% of patients will develop AL following surgery, and they will be compared to non-leakage patients. The objectives of this study are twofold. The primary aim is to establish and validate a diagnostic algorithm for the pre-operative prediction of the risk of AL development using a combination of inflammatory, immune-related, and genetic parameters. Previously established risk factors and novel parameters will be incorporated into this algorithm, which will aid in the recognition of patients who are at risk for AL. Based on these results, recommendations can be made regarding the construction of an anastomosis or deviating stoma, and possible preventive strategies. Furthermore, we aim to develop a new algorithm for the post-operative diagnosis of AL at an

  6. Effect of two sedative protocols and hepatosplenic disease on Doppler indices of splenic arteries in dogs: a preliminary study.

    PubMed

    Ferrandis, Inma; Jakovljevic, Samuel; Aprea, Francesco; Corletto, Federico

    2013-09-01

    Doppler flow indices (DFIs), such as the resistive index (RI) and the pulsatility index (PI), are commonly used to characterize blood flow. Parenchymal infiltration of an organ and administration of sedative and anaesthetic drugs can affect DFIs by altering resistance to blood flow. In this prospective study, the effect on DFIs of two sedative protocols (acepromazine or dexmedetomidine, each combined with butorphanol) and the presence or absence of hepatic and/or splenic disease, was investigated in the splenic arteries of 75 dogs. The RI and PI in splenic arteries of dogs sedated with dexmedetomidine and butorphanol were lower than those of dogs sedated with acepromazine and butorphanol. PI in splenic arteries was higher in animals with hepatosplenic disease than in healthy animals. Receiver Operating Characteristic (ROC) curves suggested that PI measured in canine splenic arteries could be useful in predicting the presence of hepatosplenic disease in the absence of other abdominal disease.

  7. Enhanced Evidence-Based Chinese Medicine Clinical Practice Guidelines in Hong Kong: A Study Protocol for Three Common Diseases

    PubMed Central

    Shi, Nannan; Zhong, Linda L. D.; Han, XueJie; Ng, Bacon; Bian, Zhaoxiang; Lu, Aiping

    2015-01-01

    We presented a study protocol of developing Chinese medicine clinical practice guidelines for three common diseases in Hong Kong, including insomnia, chronic gastritis, and cerebral infarction. This research project will be conducted in three phases. First phase is the preparation stage which consists of the establishment of steering committee and panel. Second phase involves 6 steps, which are searching and identifying evidence, text mining process, Delphi survey, synthesizing of data, consensus conference, and drafting guidelines. In this phase, text mining technique, evidence-based method, and formal consensus method are combined to get consolidated supporting data as the source of CM CPGs. The final phase comprised external reviews, dissemination, and updating. The outputs from this project will provide three CM CPGs for insomnia, chronic gastritis, and cerebral infarction for Hong Kong local use. PMID:25815035

  8. Social facilitation maintenance treatment for adults with obesity: study protocol for a randomised-controlled feasibility study (SFM study)

    PubMed Central

    Hilbert, Anja

    2016-01-01

    Introduction 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. Methods and analysis 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. Ethics and dissemination 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. Trial registration number DRKS00005182. PMID:27580827

  9. EVALUATION OF THE PROTOCOL FOR THE NATURAL ATTENUATION OF CHLORINATED SOLVENTS: CASE STUDY AT THE TWIN CITIES ARMY AMMUNITION PLANT

    EPA Science Inventory

    At the request of staff in the EPA Regions, EPA?s Office of Research and Development carried out an independent evaluation of the Technical Protocol for Evaluating Natural Attenuation of Chlorinated Solvents in Ground Water (EPA/600/R-98/128). The Protocol was developed around c...

  10. An Examination of the Design, Development, and Implementation of an Internet Protocol Version 6 Network: The ADTRAN Inc. Case Study

    ERIC Educational Resources Information Center

    Perigo, Levi

    2013-01-01

    In this dissertation, the author examined the capabilities of Internet Protocol version 6 (IPv6) in regard to replacing Internet Protocol version 4 (IPv4) as the internetworking technology for Medium-sized Businesses (MBs) in the Information Systems (IS) field. Transition to IPv6 is inevitable, and, thus, organizations are adopting this protocol…

  11. Combining motivational and volitional strategies to promote unsupervised walking in patients with fibromyalgia: study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Fibromyalgia patients are often advised to engage in regular low- to moderate-intensity physical exercise. The need of fibromyalgia patients to walk has been stressed in previous research. Behavioral self-regulation theories suggest that a combination of motivational aspects (to develop or strengthen a behavioral intention: Theory of Planned Behavior) and volitional aspects (engagement of intention in behavior: implementation intentions) is more effective than a single intervention. In this paper, we describe a protocol for identifying the motivational processes (using the Theory of Planned Behavior) involved in the practice of walking (phase I) and for studying the efficacy of an intervention that combines motivational and volitional contents to enhance the acquisition and continuation of this exercise behavior (phase II). The paper also shows the characteristics of eligible individuals (women who do not walk) and ineligible populations (women who walk or do not walk because of comorbidity without medical recommendation to walk). Both groups consist of members of any of four patients’ associations in Spain who are between 18 and 70 years of age and meet the London Fibromyalgia Epidemiology Study Screening Questionnaire criteria for fibromyalgia. Furthermore, using this study protocol, we will explore the characteristics of participants (eligible women who agreed to participate in the study) and nonparticipants (eligible women who refused to participate). Methods/design Two studies will be conducted: Phase I will be a cross-sectional study, and phase II will be a triple-blind, randomized longitudinal study with two treatment groups and one active control group. The questionnaires were sent to a total of 2,227 members of four patients’ associations in Spain. A total of 920 participants with fibromyalgia returned the questionnaires, and 582 were ultimately selected to participate. Discussion The first data gathered have allowed us to identify the

  12. Prospective research on musculoskeletal disorders in office workers (PROMO): study protocol

    PubMed Central

    IJmker, Stefan; Blatter, Birgitte M; van der Beek, Allard J; van Mechelen, Willem; Bongers, Paulien M

    2006-01-01

    Background This article describes the background and study design of the PROMO study (Prospective Research on Musculoskeletal disorders in Office workers). Few longitudinal studies have been performed to investigate the risk factors responsible for the incidence of hand, arm, shoulder and neck symptoms among office workers, given the observation that a large group of office workers might be at risk worldwide. Therefore, the PROMO study was designed. The main aim is to quantify the contribution of exposure to occupational computer use to the incidence of hand, arm, shoulder and neck symptoms. The results of this study might lead to more effective and/or cost-efficient preventive interventions among office workers. Methods/Design A prospective cohort study is conducted, with a follow-up of 24 months. In total, 1821 participants filled out the first questionnaire (response rate of 74%). Data on exposure and outcome is collected using web-based self-reports. Outcome assessment takes place every three months during the follow-up period. Data on computer use are collected at baseline and continuously during follow-up using a software program. Discussion The advantages of the PROMO study include the long follow-up period, the repeated measurement of both exposure and outcome, and the objective measurement of the duration of computer use. In the PROMO study, hypotheses stemming from lab-based and field-based research will be investigated. PMID:16822300

  13. “Non-canonical protein-DNA interactions identified by ChIP are not artifacts”: response

    PubMed Central

    2013-01-01

    Background Studies of protein association with DNA on a genome wide scale are possible through methods like ChIP-Chip or ChIP-Seq. Massive problems with false positive signals in our own experiments motivated us to revise the standard ChIP-Chip protocol. Analysis of chromosome wide binding of the alternative sigma factor σ32 in Escherichia coli with this new protocol resulted in detection of only a subset of binding sites found in a previous study by Wade and colleagues. We suggested that the remainder of binding sites detected in the previous study are likely to be false positives. In a recent article the Wade group claimed that our conclusion is wrong and that the disputed sites are genuine σ32 binding sites. They further claimed that the non-detection of these sites in our study was due to low data quality. Results/discussion We respond to the criticism of Wade and colleagues and discuss some general questions of ChIP-based studies. We outline why the quality of our data is sufficient to derive meaningful results. Specific points are: (i) the modifications we introduced into the standard ChIP-Chip protocol do not necessarily result in a low dynamic range, (ii) correlation between ChIP-Chip replicates should not be calculated based on the whole data set as done in transcript analysis, (iii) control experiments are essential for identifying false positives. Suggestions are made how ChIP-based methods could be further optimized and which alternative approaches can be used to strengthen conclusions. Conclusion We appreciate the ongoing discussion about the ChIP-Chip method and hope that it helps other scientist to analyze and interpret their results. The modifications we introduced into the ChIP-Chip protocol are a first step towards reducing false positive signals but there is certainly potential for further optimization. The discussion about the σ32 binding sites in question highlights the need for alternative approaches and further investigation of appropriate

  14. Indoor air pollution on nurseries and primary schools: impact on childhood asthma – study protocol

    PubMed Central

    2012-01-01

    Background Several studies have demonstrated an association between the exposure to indoor air pollution (IAP) and childhood asthma. Evidence is suggesting that several air pollutants may contribute to both exacerbation and development of asthma, but some uncertainty remains concerning the specific causative role of IAP. This paper reports an epidemiologic study aiming to reduce the existing lacks on the association between long-term exposure to pollution mixtures and the development and exacerbation of childhood asthma. Methods/design Based on the implementation of the study in 8 nurseries and 8 primary schools, from which, 2 nurseries and 2 primary schools in sites influenced by traffic and other 2 nurseries and 2 primary schools in background sites at urban and rural areas, the study will analyse the exposure to both urban and rural pollution as well as to traffic emissions (some homes of the children will be included in the study). Furthermore, based on the answers to validated questionnaires (as those used in the International Study of Asthma and Allergies in Childhood - ISAAC) filled in by the parents and on medical exams, the study will assess the prevalence, incidence and exacerbation of asthma, thus considering both short and long-term effects. The approximate number of children in the study will never be less than 600, guaranteeing 80% of study power (significant at a 5% level). Discussion This study intends to contribute for the understanding of the role of environmental factors, namely indoor air pollution, on asthma considering a risk group of different ages, and for the development of preventive measures, which are considered priority issues by the European Commission, according to the European Environmental Agency and the World Health Organization. PMID:22694910

  15. ‘Omics’ biomarkers associated with chronic low back pain: protocol of a retrospective longitudinal study

    PubMed Central

    Allegri, Massimo; Klersy, Catherine; Wang, Wei; Sim, Moira; Gieger, Christian; Manz, Judith; Pemberton, Iain K; MacDougall, Jane; Williams, Frances MK; Van Zundert, Jan; Buyse, Klaas; Lauc, Gordan; Gudelj, Ivan; Primorac, Dragan; Skelin, Andrea; Aulchenko, Yurii S; Karssen, Lennart C; Kapural, Leonardo; Rauck, Richard; Fanelli, Guido

    2016-01-01

    Introduction Chronic low back pain (CLBP) produces considerable direct costs as well as indirect burdens for society, industry and health systems. CLBP is characterised by heterogeneity, inclusion of several pain syndromes, different underlying molecular pathologies and interaction with psychosocial factors that leads to a range of clinical manifestations. There is still much to understand in the underlying pathological processes and the non-psychosocial factors which account for differences in outcomes. Biomarkers that may be objectively used for diagnosis and personalised, targeted and cost-effective treatment are still lacking. Therefore, any data that may be obtained at the ‘-omics’ level (glycomics, Activomics and genome-wide association studies—GWAS) may be helpful to use as dynamic biomarkers for elucidating CLBP pathogenesis and may ultimately provide prognostic information too. By means of a retrospective, observational, case-cohort, multicentre study, we aim to investigate new promising biomarkers potentially able to solve some of the issues related to CLBP. Methods and analysis The study follows a two-phase, 1:2 case–control model. A total of 12 000 individuals (4000 cases and 8000 controls) will be enrolled; clinical data will be registered, with particular attention to pain characteristics and outcomes of pain treatments. Blood samples will be collected to perform -omics studies. The primary objective is to recognise genetic variants associated with CLBP; secondary objectives are to study glycomics and Activomics profiles associated with CLBP. Ethics and dissemination The study is part of the PainOMICS project funded by European Community in the Seventh Framework Programme. The study has been approved from competent ethical bodies and copies of approvals were provided to the European Commission before starting the study. Results of the study will be reviewed by the Scientific Board and Ethical Committee of the PainOMICS Consortium. The

  16. Family-Centered Care in Juvenile Justice Institutions: A Mixed Methods Study Protocol

    PubMed Central

    Mulder, Eva; Rigter, Henk; Breuk, René; van der Vaart, Wander; Vermeiren, Robert

    2016-01-01

    Background Treatment and rehabilitation interventions in juvenile justice institutions aim to prevent criminal reoffending by adolescents and to enhance their prospects of successful social reintegration. There is evidence that these goals are best achieved when the institution adopts a family-centered approach, involving the parents of the adolescents. The Academic Workplace Forensic Care for Youth has developed two programs for family-centered care for youth detained in groups for short-term and long-term stay, respectively. Objective The overall aim of our study is to evaluate the family-centered care program in the first two years after the first steps of its implementation in short-term stay groups of two juvenile justice institutions in the Netherlands. The current paper discusses our study design. Methods Based on a quantitative pilot study, we opted for a study with an explanatory sequential mixed methods design. This pilot is considered the first stage of our study. The second stage of our study includes concurrent quantitative and qualitative approaches. The quantitative part of our study is a pre-post quasi-experimental comparison of family-centered care with usual care in short-term stay groups. The qualitative part of our study involves in-depth interviews with adolescents, parents, and group workers to elaborate on the preceding quantitative pilot study and to help interpret the outcomes of the quasi-experimental quantitative part of the study. Results We believe that our study will result in the following findings. In the quantitative comparison of usual care with family-centered care, we assume that in the latter group, parents will be more involved with their child and with the institution, and that parents and adolescents will be more motivated to take part in therapy. In addition, we expect family-centered care to improve family interactions, to decrease parenting stress, and to reduce problem behavior among the adolescents. Finally, we assume

  17. Epidemiology of Patient Harms in New Zealand: Protocol of a General Practice Records Review Study

    PubMed Central

    Leitch, Sharon; Wallis, Katharine A; Eggleton, Kyle S; Cunningham, Wayne K; Williamson, Martyn I; Lillis, Steven; McMenamin, Andrew W; Tilyard, Murray W; Reith, David M; Samaranayaka, Ari; Hall, Jason E

    2017-01-01

    Background Knowing where and why harm occurs in general practice will assist patients, doctors, and others in making informed decisions about the risks and benefits of treatment options. Research to date has been unable to verify the safety of primary health care and epidemiological research about patient harms in general practice is now a top priority for advancing health systems safety. Objective We aim to study the incidence, distribution, severity, and preventability of the harms patients experience due to their health care, from the whole-of-health-system lens afforded by electronic general practice patient records. Methods “Harm” is defined as disease, injury, disability, suffering, and death, arising from the health system. The study design is a stratified, 2-level cluster, retrospective records review study. Both general practices and patients will be randomly selected so that the study’s results will apply nationally, after weighting. Stratification by practice size and rurality will allow comparisons between 6 study groups (large, medium-sized, small; urban and rural practices). Records of equal numbers of patients from each study group will be included in the study because there may be systematic differences in patient harms in different types of practices. Eight general practitioner investigators will review 3 years of electronic general practice health records (consultation notes, prescriptions, investigations, referrals, and summaries of hospital care) from 9000 patients registered in 60 general practices. Double-blinded reviews will check the concordance of reviewers’ assessments. Study data will comprise demographic data of all 9000 patients and reviewers’ assessments of whether patients experienced harm arising from health care. Where patient harm is identified, their types, preventability, severity, and outcomes will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) 18.0. Results We have recruited practices and

  18. 40 CFR 160.120 - Protocol.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... PRACTICE STANDARDS Protocol for and Conduct of a Study § 160.120 Protocol. (a) Each study shall have an... study. The protocol shall contain but shall not necessarily be limited to the following information: (1) A descriptive title and statement of the purpose of the study. (2) Identification of the...

  19. 40 CFR 160.120 - Protocol.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... PRACTICE STANDARDS Protocol for and Conduct of a Study § 160.120 Protocol. (a) Each study shall have an... study. The protocol shall contain but shall not necessarily be limited to the following information: (1) A descriptive title and statement of the purpose of the study. (2) Identification of the...

  20. 21 CFR 58.120 - Protocol.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... sponsor and the dated signature of the study director. (12) A statement of the proposed statistical... FOR NONCLINICAL LABORATORY STUDIES Protocol for and Conduct of a Nonclinical Laboratory Study § 58.120 Protocol. (a) Each study shall have an approved written protocol that clearly indicates the objectives...

  1. 40 CFR 160.120 - Protocol.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... PRACTICE STANDARDS Protocol for and Conduct of a Study § 160.120 Protocol. (a) Each study shall have an... study. The protocol shall contain but shall not necessarily be limited to the following information: (1) A descriptive title and statement of the purpose of the study. (2) Identification of the...

  2. 40 CFR 160.120 - Protocol.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... PRACTICE STANDARDS Protocol for and Conduct of a Study § 160.120 Protocol. (a) Each study shall have an... study. The protocol shall contain but shall not necessarily be limited to the following information: (1) A descriptive title and statement of the purpose of the study. (2) Identification of the...

  3. Implementation of a population-based epidemiological rare disease registry: study protocol of the amyotrophic lateral sclerosis (ALS) - registry Swabia

    PubMed Central

    2013-01-01

    Background The social and medical impact of rare diseases is increasingly recognized. Amyotrophic lateral sclerosis (ALS) is the most prevalent of the motor neuron diseases. It is characterized by rapidly progressive damage to the motor neurons with a survival of 2–5 years for the majority of patients. The objective of this work is to describe the study protocol and the implementation steps of the amyotrophic lateral sclerosis (ALS) registry Swabia, located in the South of Germany. Methods/Design The ALS registry Swabia started in October 2010 with both, the retrospective (01.10.2008-30.09.2010) and prospective (from 01.10.2010) collection of ALS cases, in a target population of 8.6 million persons in Southern Germany. In addition, a population based case–control study was implemented based on the registry that also included the collection of various biological materials. Retrospectively, 420 patients (222 men and 198 women) were identified. Prospectively data of ALS patients were collected, of which about 70% agreed to participate in the population-based case–control study. All participants in the case–control study provided also a blood sample. The prospective part of the study is ongoing. Discussion The ALS registry Swabia has been implemented successfully. In rare diseases such as ALS, the collaboration of registries, the comparison with external samples and biorepositories will facilitate to identify risk factors and to further explore the potential underlying pathophysiological mechanisms. PMID:23414001

  4. A multimethod research investigation of consumer involvement in Australian health service accreditation programmes: the ACCREDIT-SCI study protocol

    PubMed Central

    Greenfield, David; Hinchcliff, Reece; Moldovan, Max; Mumford, Virginia; Pawsey, Marjorie; Irene Westbrook, Johanna; Braithwaite, Jeffrey

    2012-01-01

    Introduction Health service accreditation programmes are a regulatory mechanism adopted to drive improvements inpatient safety and quality. Research investigating the benefits or limitations, of consumer involvement in accreditation programmes is negligible. To develop our knowledge in this area the ACCREDIT collaboration (Accreditation Collaborative for the Conduct of Research, Evaluation and Designated Investigations through Teamwork) has developed a research plan, known as the ACCREDIT-SCI (Standards of Consumer Involvement) study protocol. Two complementary studies have been designed: one, to examine the effectiveness of a standard for consumer participation and two, to explore how patient experiences vary across a range of settings with differing accreditation results. Methods and design The research setting is the Australian healthcare system, and the two studies focus on three accreditation programmes in the primary, acute and aged care domains. The studies will use multimethods: document analysis; interviews and surveys. Participants will be stakeholders across the three domains including: policy officers; frontline healthcare professionals; accreditation agency personnel, including surveyors and healthcare consumers. Drawing on previous experience, the research team has developed purpose-designed tools. Data will be analysed using thematic, narrative and statistical (descriptive and inferential) procedures. Ethics and dissemination The University of New South Wales Human Research Ethics Committee has approved the two studies (HREC 10274). Findings will be disseminated through seminars, conference presentations, academic publications and research partner websites. The findings will be formulated to facilitate uptake by policy and accreditation agency professionals, researchers and academics, and consumers, nationally and internationally. PMID:23059848

  5. Large-Scale Wearable Sensor Deployment in Parkinson’s Patients: The Parkinson@Home Study Protocol

    PubMed Central

    Hahn, Tim; de Vries, Nienke M; Cohen, Eli; Bataille, Lauren; Little, Max A; Baldus, Heribert; Bloem, Bastiaan R; Faber, Marjan J

    2016-01-01

    Background Long-term management of Parkinson’s disease does not reach its full potential because we lack knowledge about individual variations in clinical presentation and disease progression. Continuous and longitudinal assessments in real-life (ie, within the patients’ own home environment) might fill this knowledge gap. Objective The primary aim of the Parkinson@Home study is to evaluate the feasibility and compliance of using multiple wearable sensors to collect clinically relevant data. Our second aim is to address the usability of these data for answering clinical research questions. Finally, we aim to build a database for future validation of novel algorithms applied to sensor-derived data from Parkinson’s patients during daily functioning. Methods The Parkinson@Home study is a two-phase observational study involving 1000 Parkinson’s patients and 250 physiotherapists. Disease status is assessed using a short version of the Parkinson's Progression Markers Initiative protocol, performed by certified physiotherapists. Additionally, participants will wear a set of sensors (smartwatch, smartphone, and fall detector), and use these together with a customized smartphone app (Fox Insight), 24/7 for 3 months. The sensors embedded within the smartwatch and fall detector may be used to estimate physical activity, tremor, sleep quality, and falls. Medication intake and fall incidents will be measured via patients’ self-reports in the smartphone app. Phase one will address the feasibility of the study protocol. In phase two, mathematicians will distill relevant summary statistics from the raw sensor signals, which will be compared against the clinical outcomes. Results Recruitment of 300 participants for phase one was concluded in March, 2016, and the follow-up period will end in June, 2016. Phase two will include the remaining participants, and will commence in September, 2016. Conclusions The Parkinson@Home study is expected to generate new insights into the

  6. Elder mistreatment in a community dwelling population: the Malaysian Elder Mistreatment Project (MAESTRO) cohort study protocol

    PubMed Central

    Choo, Wan Yuen; Hairi, Noran Naqiah; Sooryanarayana, Rajini; Yunus, Raudah Mohd; Hairi, Farizah Mohd; Ismail, Norliana; Kandiben, Shathanapriya; Mohd Ali, Zainudin; Ahmad, Sharifah Nor; Abdul Razak, Inayah; Othman, Sajaratulnisah; Tan, Maw Pin; Mydin, Fadzilah Hanum Mohd; Peramalah, Devi; Brownell, Patricia; Bulgiba, Awang

    2016-01-01

    Introduction Despite being now recognised as a global health concern, there is still an inadequate amount of research into elder mistreatment, especially in low and middle-income regions. The purpose of this paper is to report on the design and methodology of a population-based cohort study on elder mistreatment among the older Malaysian population. The study aims at gathering data and evidence to estimate the prevalence and incidence of elder mistreatment, identify its individual, familial and social determinants, and quantify its health consequences. Methods and analysis This is a community-based prospective cohort study using randomly selected households from the national census. A multistage sampling method was employed to obtain a total of 2496 older adults living in the rural Kuala Pilah district. The study is divided into two phases: cross-sectional study (baseline), and a longitudinal follow-up study at the third and fifth years. Elder mistreatment was measured using instrument derived from the previous literature and modified Conflict Tactic Scales. Outcomes of elder mistreatment include mortality, physical function, mental health, quality of life and health utilisation. Logistic regression models are used to examine the relationship between risk factors and abuse estimates. Cox proportional hazard regression will be used to estimate risk of mortality associated with abuse. Associated annual rate of hospitalisation and health visit frequency, and reporting of abuse, will be estimated using Poisson regression. Ethics and dissemination The study has been approved by the Medical Ethics Committee of the University of Malaya Medical Center (MEC Ref 902.2) and the Malaysian National Medical Research Register (NMRR-12-1444-11726). Written consent was obtained from all respondents prior to baseline assessment and subsequent follow-up. Findings will be disseminated to local stakeholders via forums with community leaders, and health and social welfare departments

  7. The Ethnic/Racial Variations of Intracerebral Hemorrhage (ERICH) Study Protocol

    PubMed Central

    Woo, Daniel; Rosand, Jonathan; Kidwell, Chelsea; McCauley, Jacob L.; Osborne, Jennifer; Brown, Mark W.; West, Sandra E.; Rademacher, Eric W.; Waddy, Salina; Roberts, Jamie N.; Koch, Sebastian; Gonzales, Nicole R.; Sung, Gene; Kittner, Steven J.; Birnbaum, Lee; Frankel, Michael; Daniel Testai, Fernando; Hall, Christiana E.; Elkind, Mitchell S. V.; Flaherty, Matthew; Coull, Bruce; Chong, Ji Y.; Warwick, Tanya; Malkoff, Marc; James, Michael L.; Ali, Latisha K.; Worrall, Bradford B.; Jones, Floyd; Watson, Tiffany; Leonard, Anne; Martinez, Rebecca; Sacco, Ralph I; Langefeld, Carl D.

    2013-01-01

    Background and Purpose Epidemiologic studies of intracerebral hemorrhage (ICH) have consistently demonstrated variation in incidence, location, age at presentation, and outcomes among non-Hispanic white, black, and Hispanic populations. We report here the design and methods for this large, prospective, multi-center case-control study of ICH. Methods The ERICH study is a multi-center, prospective case-control study of ICH. Cases are identified by hot-pursuit and enrolled using standard phenotype and risk factor information and include neuroimaging and blood sample collection. Controls are centrally identified by random digit dialing to match cases by age (+/−5 years), race, ethnicity, gender and metropolitan region. Results As of March 22, 2013, 1,655 cases of ICH had been recruited into the study which is 101.5% of the target for that date and 851 controls had been recruited which is 67.2% of the target for that date (1,267 controls) for a total of 2,506 subjects which is 86.5% of the target for that date (2,897 subjects). Of the 1,655 cases enrolled, 1,640 cases had the case interview entered into the database of which 628 (38%) were non-Hispanic black, 458 (28%) were non-Hispanic white and 554 (34%) were Hispanic. Of the 1,197 cases with imaging submitted, 876 (73.2%) had a 24 hour follow-up CT available In addition to CT imaging, 607 cases have had MRI evaluation. Conclusion The ERICH study is a large, case-control study of ICH with particular emphasis on recruitment of minority populations for the identification of genetic and epidemiologic risk factors for ICH and outcomes after ICH. PMID:24021679

  8. NanoVelcro Chip for CTC enumeration in prostate cancer patients.

    PubMed

    Lu, Yi-Tsung; Zhao, Libo; Shen, Qinglin; Garcia, Mitch A; Wu, Dongxia; Hou, Shuang; Song, Min; Xu, Xiaochun; Ouyang, Wei-Han; Ouyang, William W-L; Lichterman, Jake; Luo, Zheng; Xuan, Xuan; Huang, Jiaoti; Chung, Leland W K; Rettig, Matthew; Tseng, Hsian-Rong; Shao, Chen; Posadas, Edwin M

    2013-12-01

    Circulating tumor cells (CTCs) are one of the most crucial topics in rare cell biology and have become the focus of a significant and emerging area of cancer research. While CTC enumeration is a valid biomarker in prostate cancer, the current FDA-approved CTC technology is unable to detect CTCs in a large portion of late stage prostate cancer patients. Here we introduce the NanoVelcro CTC Chip, a device composed of a patterned silicon nanowire substrate (SiNW) and an overlaid polydimethylsiloxane (PDMS) chaotic mixer. Validated by two institutions participating in the study, the NanoVelcro Chip assay exhibits very consistent efficiency in CTC-capture from patient samples. The utilized protocol can be easily replicated at different facilities. We demonstrate the clinical utility of the NanoVelcro Chip by performing serial enumerations of CTCs in prostate cancer patients after undergoing systemic therapy. Changes in CTC numbers after 4-10 weeks of therapy were compared with their clinical responses. We observed a statistically significant reduction in CTCs counts in the clinical responders. We performed long-term follow up with serial CTC collection and enumeration in one patient observing variations in counts correlating with treatment response. This study demonstrates the consistency of the NanoVelcro Chip assay over time for CTC enumeration and also shows that continuous monitoring of CTC numbers can be employed to follow responses to different treatments and monitor disease progression.

  9. Pilot study to evaluate 3 hygiene protocols on the reduction of bacterial load on the hands of veterinary staff performing routine equine physical examinations

    PubMed Central

    Traub-Dargatz, Josie L.; Weese, J. Scott; Rousseau, Joyce D.; Dunowska, Magdalena; Morley, Paul S.; Dargatz, David A.

    2006-01-01

    Abstract Reduction factors (RFs) for bacterial counts on examiners’ hands were compared when performing a standardized equine physical examination, followed by the use of one of 3 hand-hygiene protocols (washing with soap, ethanol gel application, and chlorohexidine-ethanol application). The mean RFs were 1.29 log10 and 1.44 log10 at 2 study sites for the alcohol-gel (62% ethyl alcohol active ingredient) protocols and 1.47 log10 and 1.94 log10 at 2 study sites for the chlorhexidine-alcohol (61% ethyl alcohol plus 1% chlorhexidine active ingredients) protocols, respectively. The RFs were significantly different (P < 0.0001) between the hand-washing group and the other 2 treatment groups (the alcohol-gel and the chlorhexidine-alcohol lotion). The use of alcohol-based gels or chlorhexidine-alcohol hand hygiene protocols must still be proven effective in equine practice settings, but in this study, these protocols were equivalent or superior to hand washing for reduction in bacterial load on the hands of people after they perform routine physical examinations. PMID:16898109

  10. Pilot study to evaluate 3 hygiene protocols on the reduction of bacterial load on the hands of veterinary staff performing routine equine physical examinations.

    PubMed

    Traub-Dargatz, Josie L; Weese, J Scott; Rousseau, Joyce D; Dunowska, Magdalena; Morley, Paul S; Dargatz, David A

    2006-07-01

    Reduction factors (RFs) for bacterial counts on examiners' hands were compared when performing a standardized equine physical examination, followed by the use of one of 3 hand-hygiene protocols (washing with soap, ethanol gel application, and chlorohexidine-ethanol application). The mean RFs were 1.29 log10 and 1.44 log10 at 2 study sites for the alcohol-gel (62% ethyl alcohol active ingredient) protocols and 1.47 log10 and 1.94 log10 at 2 study sites for the chlorhexidine-alcohol (61% ethyl alcohol plus 1% chlorhexidine active ingredients) protocols, respectively. The RFs were significantly different (P < 0.0001) between the hand-washing group and the other 2 treatment groups (the alcohol-gel and the chlorhexidine-alcohol lotion). The use of alcohol-based gels or chlorhexidine-alcohol hand hygiene protocols must still be proven effective in equine practice settings, but in this study, these protocols were equivalent or superior to hand washing for reduction in bacterial load on the hands of people after they perform routine physical examinations.

  11. A Checklist for the Conduct, Reporting, and Appraisal of Microcosting Studies in Health Care: Protocol Development

    PubMed Central

    Reiff, Marian

    2016-01-01

    Background Microcosting is a cost estimation method that requires the collection of detailed data on resources utilized, and the unit costs of those resources in order to identify actual resource use and economic costs. Microcosting findings reflect the true costs to health care systems and to society, and are able to provide transparent and consistent estimates. Many economic evaluations in health and medicine use charges, prices, or payments as a proxy for cost. However, using charges, prices, or payments rather than the true costs of resources can result in inaccurate estimates. There is currently no existing checklist or guideline for the conduct, reporting, or appraisal of microcosting studies in health care interventions. Objective The aim of this study is to create a checklist and guideline for the conduct, reporting, and appraisal of microcosting studies in health care interventions. Methods Appropriate potential domains and items will be identified through (1) a systematic review of all published microcosting studies of health and medical interventions, strategies, and programs; (2) review of published checklists and guidelines for economic evaluations of health interventions, and selection of items relevant for microcosting studies; and (3) theoretical analysis of economic concepts relevant for microcosting. Item selection, formulation, and reduction will be conducted by the research team in order to develop an initial pool of items for evaluation by an expert panel comprising individuals with expertise in microcosting and economic evaluation of health interventions. A modified Delphi process will be conducted to achieve consensus on the checklist. A pilot test will be conducted on a selection of the articles selected for the previous systematic review of published microcosting studies. Results The project is currently in progress. Conclusions Standardization of the methods used to conduct, report or appraise microcosting studies will enhance the

  12. Complementary feeding and the early origins of obesity risk: a study protocol

    PubMed Central

    Muniandy, Naleena Devi; Allotey, Pascale A; Soyiri, Ireneous N; Reidpath, Daniel D

    2016-01-01

    Introduction The rise in the prevalence of childhood obesity worldwide calls for an intervention earlier in the life cycle. Studies show that nutrition during early infancy may contribute to later obesity. Hence, this study is designed to determine if the variation in complementary feeding practices poses a risk for the development of obesity later in life. A mixed methods approach will be used in conducting this study. Methods and analysis The target participants are infants born from January to June 2015 in the South East Asia Community Observatory (SEACO) platform. The SEACO is a Health and Demographic Surveillance System (HDSS) that is established in the District of Segamat in the state of Johor, Malaysia. For the quantitative strand, the sociodemographic data, feeding practices, anthropometry measurement and total nutrient intake will be assessed. The assessment will occur around the time complementary feeding is expected to start (7 Months) and again at 12 months. A 24-hour diet recall and a 2-day food diary will be used to assess the food intake. For the qualitative strand, selected mothers will be interviewed to explore their infant feeding practices and factors that influence their practices and food choices in detail. Ethics and dissemination Ethical clearance for this study was sought through the Monash University Human Research and Ethics Committee (application number CF14/3850-2014002010). Subsequently, the findings of this study will be disseminated through peer-reviewed journals, national and international conferences. PMID:27852704

  13. Identification of antibiotic resistant bacteria community and a GeoChip based study of resistome in urban watersheds.

    PubMed

    Low, Adrian; Ng, Charmaine; He, Jianzhong

    2016-12-01

    Urban watersheds from point sources are potential reservoirs of antibiotic resistance genes (ARGs). However, few studies have investigated urban watersheds of non-point sources. To understand the type of ARGs and bacteria that might carry such genes, we investigated two non-point source urban watersheds with different land-use profiles. Antibiotic resistance levels of two watersheds (R1, R3) were examined using heterotrophic plate counts (HPC) as a culturing method to obtain counts of bacteria resistant to seven antibiotics belonging to different classes (erythromycin, kanamycin, lincomycin, norfloxacin, sulfanilamide, tetracycline and trimethoprim). From the HPC study, 239 antibiotic resistant bacteria were characterized for resistance to more antibiotics. Furthermore, ARGs and antimicrobial biosynthesis genes were identified using GeoChip version 5.0 to elucidate the resistomes of surface waters in watersheds R1 and R3. The HPC study showed that water samples from R1 had significantly higher counts of bacteria resistant to erythromycin, kanamycin, norfloxacin, sulfanilamide, tetracycline and trimethoprim than those from R3 (Analysis of Similarity (ANOSIM), R = 0.557, p < 0.01). Of the seven antibiotics tested, lincomycin and trimethoprim resistant bacteria are greater in abundances. The 239 antibiotic resistant isolates represent a subset of resistant bacterial populations, including bacteria not previously known for resistance. Majority of the isolates had resistance to ampicillin, vancomycin, lincomycin and trimethoprim. GeoChip revealed similar ARGs in both watersheds, but with significantly higher intensities for tetX and β-lactamase B genes in R1 than R3. The genes with the highest average normalized intensities in R1 and R3 were tetracycline (tet) and fosfomycin (fosA) resistance genes, respectively. The higher abundance of tetX genes in R1 is congruent with the higher abundance of tetracycline resistant HPC observed in R1 samples. Strong correlations

  14. Association between adiposity and systemic atherosclerosis: a protocol of a cross-sectional autopsy study

    PubMed Central

    Nishizawa, Aline; Suemoto, Claudia Kimie; Farias, Daniela Souza; Campos, Fernanda Marinho; da Silva, Karen Cristina Souza; Cuelho, Anderson; Leite, Renata Elaine Paraízo; Ferretti-Rebustini, Renata Eloah de Lucena; Grinberg, Lea Tenenholz; Farfel, José Marcelo; Jacob-Filho, Wilson; Pasqualucci, Carlos Augusto

    2016-01-01

    Introduction Adiposity has been associated with atherosclerosis in clinical studies. However, few autopsy studies have investigated this association, and they had only examined the coronary artery disease. Moreover, most studies had small sample sizes and were limited to middle-aged or young adults. Our aim is to investigate the association between adiposity and systemic atherosclerosis in an autopsy study. Methods and analysis A sample of 240 deceased with 30 years or more will be evaluated. The sample size was calculated using the lowest correlation coefficient found in previous studies (r=0.109), assuming a power of 90% and α=0.05. We will collect information about sociodemographics, frequency of previous contact of the deceased's next of kin and cardiovascular risk factors. We will measure neck, waist and hip circumferences, weight, height and abdominal subcutaneous tissue thickness, and then we will calculate the body mass index, waist-to-hip ratio, waist-to-height ratio and body shape index. We will also weigh the pericardial and abdominal visceral fat, the heart, and we will measure the left ventricular wall thickness. We will evaluate the presence of myocardial infarction, the degree of atherosclerosis in the aorta, carotid, coronary and cerebral arteries and plaque composition in carotid, coronary and cerebral arteries. For each individual, we will fix arterial and adipose tissue samples in 10% formalin and freeze another adipose tissue sample at −80°C for future studies. Ethics and dissemination Ethical approval was granted by the Ethics Committee of University of Sao Paulo Medical School, Brazil. Results will be submitted for publication in a peer-reviewed journal. PMID:27621828

  15. Impact of advanced autonomous non-medical practitioners in emergency care: protocol for a scoping study

    PubMed Central

    Sujan, Mark; Howard-Franks, Hannah; Swann, Garry; Soanes, Kirsti; Pope, Catherine; Crouch, Robert; Staniszewska, Sophie; Maxwell, Elaine; Huang, Huayi

    2017-01-01

    Introduction Emergency care services are looking for new models of care delivery to deal with changing patient demographics and increased pressures. It has been suggested that advanced non-medical practitioners might be valuable for delivering such new models of care. However, it is not clear what the impact of the deployment of advanced non-medical practitioners in emergency care is. This scoping study addresses the following research question: What is known from the literature about the different types of impact of the deployment of advanced (autonomous) non-medical practitioners in emergency care? Methods and analysis A scoping study will be undertaken to examine and map the impact of the deployment of advanced non-medical practitioners in emergency care. The scoping study follows the methodology proposed by Arksey and O'Malley. Searches will be carried out on databases of peer-reviewed literature and other sources to systematically identify and characterise the literature. Papers will be screened using a 2-stage process to identify the most relevant literature. Papers will be screened by title and abstract, followed by full-text review. Data abstraction and synthesis will be performed using a narrative thematic analysis. Ethics and dissemination We will communicate the findings to Health Education England, NHS Improvement and the Royal College of Emergency Medicine through existing links provided by members of the project team. We anticipate that the findings will also be of interest to other similar organisations internationally. By identifying gaps in the research literature, we anticipate that the study will generate recommendations for informing future high-quality research studies about the impact of advanced non-medical practitioners in emergency care as well as in other settings. The research findings will be submitted for publication to relevant peer-reviewed journals as well as professional magazines. The scoping study uses only previously published

  16. Systematic review of adherence rates by medication class in type 2 diabetes: a study protocol

    PubMed Central

    McGovern, Andrew; Tippu, Zayd; Hinton, William; Munro, Neil; Whyte, Martin; de Lusignan, Simon

    2016-01-01

    Introduction Treatment options for type 2 diabetes are becoming increasingly complex with people often prescribed multiple medications, and may include both oral and injectable therapies. There is ongoing debate about which drug classes provide the optimum second-line and third-line treatment options. In the real world, patient adherence and persistence determines medication effectiveness. A better understanding of adherence may help inform the choice of second-line and third-line drug classes. Methods and analysis This systematic review will compare adherence and persistence rates across the different classes of medication available to people with type 2 diabetes. It will include all identified studies comparing medication adherence or persistence between two or more glucose-lowering medications in people with type 2 diabetes. Research databases (MEDLINE, EMBASE, The Cochrane Library, The Register of Controlled Trials, PsychINFO and CINAHL) will be searched for relevant articles, using a comprehensive search strategy. All identified medication trials and observational studies will be included which compare adherence or persistence across classes of diabetes medication. The characteristics and outcomes of all the included studies will be reported along with a study quality grade, assessed using the Cochrane Risk Assessment Tool. The quality of adjustment for confounders of adherence or persistence will be reported for each study. Where multiple (n ≥3) studies provide compare adherence or persistence across the same 2 medication classes, a meta-analysis will be performed. Ethics and dissemination No ethics approval is required. This review and meta-analysis (where possible) will provide important information on the relative patient adherence and persistence, with the different classes of diabetes therapies. Once complete, the results will be made available by peer-reviewed publication. Trial registration number CRD42015027865. PMID:26928029

  17. Vascular biomarkers to predict response to exercise in Alzheimer's disease: the study protocol

    PubMed Central

    Li, Danni; Thomas, Robin; Tsai, Michael Y; Li, Ling; Vock, David M; Greimel, Susan; Yu, Fang

    2016-01-01

    Introduction Exercise interventions are a promising treatment for improving cognition in persons with Alzheimer's disease. This is similar to Alzheimer's disease pharmacotherapies in which only 18–48% of treated patients demonstrate improvement in cognition. Aerobic exercise interventions positively affect brain structure and function through biologically sound pathways. However, an under-studied mechanism of aerobic exercise's effects is n-3 fatty acids in plasma. The objective of this pilot study is to inform a future large-scale study to develop n-3 fatty acids-based prediction of cognitive responses to aerobic exercise treatment in Alzheimer's disease. Methods and analysis This study will recruit and follow a cohort of 25 subjects enrolled in the FIT-AD Trial, an ongoing randomised controlled trial that investigates the effects of a 6-month moderate-intensity cycling intervention on cognition and hippocampal volume in older adults with mild to moderate Alzheimer's disease over a year. This study will collect blood from subjects at baseline and at 3 and 6 months to assay vascular biomarkers (ie, plasma fatty acids). Global cognition as measured by the Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog) at baseline, 3, 6, 9 and 12 months will be used as the main outcome. A multiple linear-regression model will be used with 12-month change in cognition as the outcome and baseline measure of n-3 fatty acids or changes in the ratio of n-3 to n-6 fatty-acid levels in plasma at 3 and/or 6 months, randomised treatment group, and their interaction as predictors. Ethics and dissemination We have obtained Institutional Review Board approval for our study. We obtain consent or assent/surrogate consent from all subjects depending on their consenting capacity assessment. Data of this study are/will be stored in the Research Electronic Data Capture (REDCap). We plan to present and publish our study findings through presentations and manuscripts. Trial

  18. PILOT STUDY PROTOCOL: APPLICATION OF MEASURES OF SPONTANEOUS MOTOR ACTIVITY FOR BEHAVORIAL ASSESSMENT IN HUMAN INFANTS

    EPA Science Inventory

    As a participant in planning the National Childrens Study (NCS), EPA is interested in the investigation of key developmental disorders that may be associated with environmental exposures. This is particularly important in light of research that has established that prenatal and e...

  19. Factors influencing social and health outcomes after motor vehicle crash injury: an inception cohort study protocol

    PubMed Central

    2014-01-01

    Background There is growing evidence that health and social outcomes following motor vehicle crash injury are related to cognitive and emotional responses of the injured individual, as well as relationships between the injured individual and the compensation systems with which they interact. As most of this evidence comes from other states in Australia or overseas, investigation is therefore warranted to identify the key determinants of health and social outcomes following injury in the context of the New South Wales motor accident insurance scheme. Methods/Design In this inception cohort study, 2400 participants, aged 17 years or more, injured in a motor vehicle crash in New South Wales will be identified though hospital emergency departments, general and physiotherapy practitioners, police records and a government insurance regulator database. Participants will be initially contacted through mail. Baseline interviews will be conducted by telephone within 28 days of the injury and participants will be followed up with interviews at 6, 12 and 24 months post-injury. Health insurance and pharmaceutical prescription data will also be collected. Discussion The study results will report short and long term health and social outcomes in the study sample. Identification of factors associated with health and social outcomes following injury, including related compensation factors will provide evidence for improved service delivery, post-injury management, and inform policy development and reforms. Trial registration Australia New Zealand Clinical trial registry identification number - ACTRN12613000889752. Available at: ANZCTR Registered FISH Study. PMID:24564821

  20. WIC Infant and Toddler Feeding Practices Study: protocol design and implementation.

    PubMed

    Harrison, Gail G; Hirschman, Jay D; Owens, Tameka A; McNutt, Suzanne W; Sallack, Linnea E

    2014-03-01

    The federal Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), which began in the 1970s, has undergone revisions in the past several years, including revision to contents of the supplemental food "packages" in 2009 based on recommendations provided by an Institute of Medicine (IOM) committee of The National Academies. In 2010, the IOM held a workshop to examine and recommend research priorities for the program. The overall purpose of the current (ie, second) WIC Infant and Toddler Feeding Practices Study (ITFPS-2) is to conduct a nationally representative, longitudinal study of contemporary WIC infant and toddler feeding practices. This study will update earlier studies and collect information on variations in WIC program components. The study will also assess ways in which WIC may address obesity in early childhood and examine changes in feeding practices that may stem from the 2009 food package revisions. The sample is drawn from the universe of WIC sites nationally, excluding only those with an insufficient volume of eligible participants. Eligibility for the study includes the ability to be interviewed in English or Spanish. Approximately 8000 women and infants are being sampled, and ∼ 4000 are expected to participate. Eligible women are invited to participate during their WIC enrollment visit, and informed consent is sought. The design includes a core sample to be followed until the infant reaches age 2 y and a supplemental sample to be used in some cross-sectional analyses to ensure adequate representation of groups that might be underrepresented in the core sample. Participants will complete up to 11 interviews (core sample) or 4 interviews (supplemental sample) each except for the prenatal interview, which includes a quantitative 24-h recall of food intake for the infant. Eighty sites have been sampled across 26 states and 1 territory. Instruments have been developed and pretested in both English and Spanish, and interviewers

  1. Investigating silent strokes in hypertensives: a magnetic resonance imaging study (ISSYS): rationale and protocol design

    PubMed Central

    2013-01-01

    Background Silent brain infarcts are detected by neuroimaging in up to 20% of asymptomatic patients based on population studies. They are five times more frequent than stroke in general population, and increase significantly both with advancing age and hypertension. Moreover, they are independently associated with the risk of future stroke and cognitive decline. Despite these numbers and the clinical consequences of silent brain infarcts, their prevalence in Mediterranean populations is not well known and their role as predictors of future cerebrovascular and cardiovascular events in hypertensive remains to be determined. ISSYS (Investigating Silent Strokes in Hypertensives: a magnetic resonance imaging study) is an observational cross-sectional and longitudinal study aimed to: 1- determine the prevalence of silent cerebrovascular infarcts in a large cohort of 1000 hypertensives and to study their associated factors and 2-to study their relationship with the risk of future stroke and cognitive decline. Methods/Design Cohort study in a randomly selected sample of 1000 participants, hypertensive aged 50 to 70 years old, with no history of previous stroke or dementia. On baseline all participants will undergo a brain MRI to determine the presence of brain infarcts and other cerebrovascular lesions (brain microbleeds, white matter changes and enlarged perivascular spaces) and will be also tested to determine other than brain organ damage (heart-left ventricular hypertrophy, kidney-urine albumin to creatinine ratio, vessels-pulse wave velocity, ankle brachial index), in order to establish the contribution of other subclinical conditions to the risk of further vascular events. Several sub-studies assessing the role of 24 hour ambulatory BP monitoring and plasma or genetic biomarkers will be performed. Follow-up will last for at least 3 years, to assess the rate of further stroke/transient ischemic attack, other cardiovascular events and cognitive decline, and their

  2. Influence of societal and practice contexts on health professionals’ clinical reasoning: a scoping study protocol

    PubMed Central

    Carrier, Annie; Levasseur, Mélanie; Freeman, Andrew; Mullins, Gary; Quénec'hdu, Suzanne; Lalonde, Louise; Gagnon, Michaël; Lacasse, Francis

    2013-01-01

    Introduction In a context of constrained resources, the efficacy of interventions is a pivotal aim of healthcare systems worldwide. Efficacy of healthcare interventions is highly compromised if clinical reasoning (CR), the process that practitioners use to plan, direct, perform and reflect on client care, is not optimal. The CR process of health professionals is influenced by the institutional dimension (ie, legal, regulatory, administrative and organisational aspects) of their societal and practice contexts. Although several studies have been conducted with respect to the institutional dimension influencing health professionals’ CR, no clear integration of their results is yet available. The aim of this study is to synthesise and disseminate current knowledge on the influence of the institutional dimension of contexts on health professionals’ CR. Methods and analysis A scoping study of the scientific literature from January 1980 to March 2013 will be undertaken to summarise and disseminate research findings about the influence of the institutional dimension on CR. Numerous databases (n=18) from three relevant fields (healthcare, health law and politics and management) will be searched. Extended search strategies will include the manual search of bibliographies, health-related websites, public registries and journals of interest. Data will be collected and analysed using a thematic chart and content analysis. A systematic multidisciplinary team approach will allow optimal identification of relevant studies, as well as effective and valid content analysis and dissemination of the results. Discussion This scoping study will provide a rigorous, accurate and up-to-date synthesis of existing knowledge regarding: (1) those aspects of the institutional dimension of health professionals’ societal and practice contexts that impact their CR and (2) how these aspects influence health professionals’ CR. Through the synergy of a multidisciplinary research team from a

  3. Safer@home—Simulation and training: the study protocol of a qualitative action research design

    PubMed Central

    Wiig, Siri; Guise, Veslemøy; Anderson, Janet; Storm, Marianne; Lunde Husebø, Anne Marie; Testad, Ingelin; Søyland, Elsa; Moltu, Kirsti L

    2014-01-01

    Introduction While it is predicted that telecare and other information and communication technology (ICT)-assisted services will have an increasingly important role in future healthcare services, their implementation in practice is complex. For implementation of telecare to be successful and ensure quality of care, sufficient training for staff (healthcare professionals) and service users (patients) is fundamental. Telecare training has been found to have positive effects on attitudes to, sustained use of, and outcomes associated with telecare. However, the potential contribution of training in the adoption, quality and safety of telecare services is an under-investigated research field. The overall aim of this study is to develop and evaluate simulation-based telecare training programmes to aid the use of videophone technology in elderly home care. Research-based training programmes will be designed for healthcare professionals, service users and next of kin, and the study will explore the impact of training on adoption, quality and safety of new telecare services. Methods and analysis The study has a qualitative action research design. The research will be undertaken in close collaboration with a multidisciplinary team consisting of researchers and managers and clinical representatives from healthcare services in two Norwegian municipalities, alongside experts in clinical education and simulation, as well as service user (patient) representatives. The qualitative methods used involve focus group interviews, semistructured interviews, observation and document analysis. To ensure trustworthiness in the data analysis, we will apply member checks and analyst triangulation; in addition to providing contextual and sample description to allow for evaluation of transferability of our results to other contexts and groups. Ethics and dissemination The study is approved by the Norwegian Social Science Data Services. The study is based on voluntary participation and informed

  4. Processes and Outcomes of the Veterans Health Administration Safe Patient Handling Program: Study Protocol

    PubMed Central

    Toyinbo, Peter; Patel, Nitin; Powell-Cope, Gail; Hahm, Bridget; Elnitsky, Christine; Besterman-Dahan, Karen; Campbell, Robert; Sutton, Bryce

    2013-01-01

    Background Health care workers, such as nurses, nursing aides, orderlies, and attendants, who manually move patients, are consistently listed in the top professions for musculoskeletal injuries (MSIs) by the Bureau of Labor Statistics. These MSIs are typically caused by high-risk patient caregiving activities. In 2008, a safe patient handling (SPH) program was implemented in all 153 Veterans Administration Medical Centers (VAMCs) throughout the United States to reduce patient handling injuries. Objective The goal of the present study is to evaluate the effects associated with the national implementation of a comprehensive SPH program. The primary objectives of the research were to determine the effectiveness of the SPH program in improving direct care nursing outcomes and to provide a context for understanding variations in program results across sites over time. Secondary objectives of the present research were to evaluate the effectiveness of the program in reducing direct and indirect costs associated with patient handling, to explore the potential mediating and moderating mechanisms, and to identify unintended consequences of implementing the program. Methods This 3-year longitudinal study used mixed methods of data collection at 6- to 9-month intervals. The analyses will include data from surveys, administrative databases, individual and focus group interviews, and nonparticipant observations. For this study, a 3-tiered measurement plan was used. For Tier 1, the unit of analysis was the facility, the data source was the facility coordinator or administrative data, and all 153 VAMCs participated. For Tier 2, frontline caregivers and program peer leaders at 17 facilities each completed different surveys. For Tier 3, six facilities completed qualitative site visits, which included individual interviews, focus groups, and nonparticipant observations. Multiple regression models were proposed to test the effects of SPH components on nursing outcomes related to

  5. Workability and Muscle Strength in Patients With Seropositive Rheumatoid Arthritis: Survey Study Protocol

    PubMed Central

    Erlacher, Ludwig; Quittan, Michael; Fenzl, Karl Heinrich; Dorner, Thomas Ernst

    2017-01-01

    Background Rheumatoid arthritis (RA) and other rheumatic conditions not only fundamentally affect patients’ quality of life and physiological needs but are also negatively associated with work ability. The costs of poor work ability, which, in sum, are more than treatment costs, pose an economic burden to society and patients. Work ability in RA appears to be multifactorial; symptoms such as pain, swelling, and stiffness play a major role, as these directly affect functional disability. Also, RA patients typically suffer from reduced muscle strength. Lower extremity function and grip strengths especially impair their quality of life. However, the role of muscle strength and disease activity as determinants of work ability have not yet been studied. Objective The primary objective of this study is to compare work ability in working-age participants with seropositive RA and with high and low disease activity; the secondary objective is to evaluate the association of muscle strength, functional ability, and frailty with work ability. Methods This monocentric cross-sectional study will be conducted at a rheumatologic outpatient clinic and day hospital with approximately 100 seropositive RA patients aged <65 years. A clinical disease activity index as a measure for rheumatoid disease activity will be assessed during the patients’ routine visits at the clinic. Work ability, frailty, and functional disability will be evaluated with (self-reported) questionnaires as well as with physical tests (Work Ability Index/Score; Health Assessment Questionnaire Disability Index; Survey of Health, Ageing, and Retirement in Europe Frailty Instrument; Short Physical Performance Battery). Muscle strength will be determined with dynamometer measurements of isometric hand grip strength and quadriceps femoris muscle contraction strength. Sleep quality (Medical Outcomes Study Sleep Scale) and sexual functioning as physiological needs will additionally be determined with self

  6. Pilot Study: Colostomy and Urine Collection Protocol for Investigating Potential Inciting Causes of Hen Diuresis Syndrome.

    PubMed

    Jones, Kelli; Turner, Bradley; Brandão, João; Hubbard, Sue Ann; Magee, Danny; Baughman, Brittany; Wills, Robert; Tully, Thomas

    2015-06-01

    Hen diuresis syndrome has emerged over the past 5 yr as a significant cause of mortality in the U.S. broiler breeder industry. The condition affects hens in production and is characterized by transient muscle weakness in the vent region, transient diuresis, and often urate deposits on the skin below the vent. Affected hens are often seen straining to lay an egg, which suggests oviduct contraction is also impaired. Related hen mortality, often reaching 1% or more a week, is believed to be primarily the result of male aggression of the vent region (Turner et al., "Investigating Causes of Excessive Urate Production in Broiler Breeder Hens Associated with Peritonitis and Cannibalism Mortality," Oral Presentation at The American Association of Avian Pathologists Annual Meeting, p. 139, 2010). The exact association between the cause of mortality and this syndrome is unknown, but it may be the consequence of transient partial to full oviduct prolapse, which predisposes or stimulates cannibalism and aggression. Based on unpublished work done prior to this study (Turner et al., ibid.), the evidence suggests the underlying problem is metabolic. We feel that urine collection and analysis is an essential component to understanding this condition. This study serves as a pilot study for future investigations that attempt to identify the nature and cause of the metabolic disturbance through paired urine and serum collection and analysis. For the purpose of this study, a small sample of 10 affected and 10 unaffected birds was used for sample collection. In order to collect pure urine, the birds were surgically colostomized. Colostomy did prove to be a useful means of collecting urine free of feces, and for the purposes of our study it yielded adequate urine samples for analysis. There were statistically relevant urine values observed. Affected birds had a higher presence of blood in the urine, a lower uric acid excretion rate (mg/hr), higher concentration (mEq/L) of urine Na+, and

  7. Diagnosis delay and follow-up strategies in colorectal cancer. Prognosis implications: a study protocol

    PubMed Central

    2010-01-01

    Background Controversy exists with regard to the impact that the different components of diagnosis delay may have on the degree of invasion and prognosis in patients with colorectal cancer. The follow-up strategies after treatment also vary considerably. The aims of this study are: a) to determine if the symptoms-to-diagnosis interval and the treatment delay modify the survival of patients with colorectal cancer, and b) to determine if different follow-up strategies are associated with a higher survival rate. Methods/Design Multi-centre study with prospective follow-up in five regions in Spain (Galicia, Balearic Islands, Catalonia, Aragón and Valencia) during the period 2010-2012. Incident cases are included with anatomopathological confirmation of colorectal cancer (International Classification of Diseases 9th revision codes 153-154) that formed a part of a previous study (n = 953). At the time of diagnosis, each patient was given a structured interview. Their clinical records will be reviewed during the follow-up period in order to obtain information on the explorations and tests carried out after treatment, and the progress of these patients. Symptoms-to-diagnosis interval is defined as the time calculated from the diagnosis of cancer and the first symptoms attributed to cancer. Treatment delay is defined as the time elapsed between diagnosis and treatment. In non-metastatic patients treated with curative intention, information will be obtained during the follow-up period on consultations performed in the digestive, surgery and oncology departments, as well as the endoscopies, tumour markers and imaging procedures carried out. Local recurrence, development of metastases in the follow-up, appearance of a new tumour and mortality will be included as outcome variables. Actuarial survival analysis with Kaplan-Meier curves, Cox regression and competitive risk survival analysis will be performed. Discussion This study will make it possible to verify if the different

  8. Mammalian Toxicology Testing: Problem Definition Study, AMTR Protocol/Pricing Report.

    DTIC Science & Technology

    1981-04-01

    fodministrotion. The tea ’ (2) Clinical laboratory testing. The acclimatization but no later than six substance must be administered in the following...present and whether the tea strain or species reacts minimum but signiricant toxicologic the rationale for selection of the specific similarly to smother...sacrificed. species, preferably albino rabbits. An (b) Study conduct. (1) Application. In All test animals, whether dying by alternative species may be used

  9. Protocol of the Swiss Longitudinal Cohort Study (SWICOS) in rural Switzerland

    PubMed Central

    Schoenenberger, Andreas W; Muggli, Franco; Parati, Gianfranco; Gallino, Augusto; Ehret, Georg; Suter, Paolo M; Schoenenberger-Berzins, Renate; Resink, Therese J; Erne, Paul

    2016-01-01

    Introduction Increased longevity and consequent major changes in demographics and population lifestyles necessitate new approaches to reduce the burden of ageing-related diseases (including cardiovascular disease) and maintain an optimal quality of life. This study aims to examine and longitudinally follow health status and disease risk factors in a Swiss rural cohort, evaluating all health-related research and practice disciplines to assure development of new implementable and successful preventive strategies for healthy ageing. Methods and objectives Small Swiss villages with low migration rates will be selected for this study. 2 villages (Cama/Lostallo) have already been selected as initial study sites. All residents (age ≥6 years, no upper age limit) are eligible. The target enrolment number per village is 300. Examinations and measurements encompass medical history, anthropometry, cardiac and vascular health, pulmonary function, physical performance, nutritional, mental and emotional status, biochemical and molecular analyses. Follow-up examinations (identical to baseline) will be performed after 5 and 10 years, and in 10-year intervals thereafter. The major objective is to assess, and observe change in, health status over time in a prospective manner. Secondary objectives are to: (1) identify ‘hidden’ (asymptomatic and/or unrecognised) health problems which enhance risk for chronic diseases; (2) identify barriers to accessing healthcare and adapting health behaviours; (3) evaluate efficacy of present preventive strategies and recommendations; (4) evaluate knowledge and attitude towards ongoing health programmes and public health recommendations; (5) monitor change and progress towards the national health objectives; (6) formulate new preventive strategies and recommendations based on the findings and knowledge base of the past 10 years; (7) formulate models for successful prevention of chronic diseases and for healthy ageing. Ethics and

  10. Medication reconciliation as a medication safety initiative in Ethiopia: a study protocol

    PubMed Central

    Mekonnen, Alemayehu B; McLachlan, Andrew J; Brien, Jo-anne E; Mekonnen, Desalew; Abay, Zenahebezu

    2016-01-01

    Introduction Medication related adverse events are common, particularly during transitions of care, and have a significant impact on patient outcomes and healthcare costs. Medication reconciliation (MedRec) is an important initiative to achieve the Quality Use of Medicines, and has been adopted as a standard practice in many developed countries. However, the impact of this strategy is rarely described in Ethiopia. The aims of this study are to explore patient safety culture, and to develop, implement and evaluate a theory informed MedRec intervention, with the aim of minimising the incidence of medication errors during hospital admission. Methods and analyses The study will be conducted in a resource limited setting. There are three phases to this project. The first phase is a mixed methods study of healthcare professionals' perspectives of patient safety culture and patients' experiences of medication related adverse events. In this phase, the Hospital Survey on Patient Safety Culture will be used along with semi-structured indepth interviews to investigate patient safety culture and experiences of medication related adverse events. The second phase will use a semi-structured interview guide, designed according to the 12 domains of the Theoretical Domains Framework, to explore the barriers and facilitators to medication safety activities delivered by hospital pharmacists. The third phase will be a single centre, before and after study, that will evaluate the impact of pharmacist conducted admission MedRec in an emergency department (ED). The main outcome measure is the incidence and potential clinical severity of medication errors. We will then analyse the differences in the incidence and severity of medication errors before and after initiation of an ED pharmacy service. PMID:27884844

  11. Parenting for Autism, Language, And Communication Evaluation Study (PALACES): protocol for a pilot randomised controlled trial

    PubMed Central

    Williams, Margiad Elen; Hastings, Richard; Charles, Joanna Mary; Evans, Sue; Hutchings, Judy

    2017-01-01

    Introduction Children with autistic spectrum disorder (ASD) often have associated behavioural difficulties that can present a challenge for parents and parenting. There are several effective social learning theory-based parenting programmes for dealing with behavioural difficulties, including the Incredible Years (IY) parent programmes. However, these programmes typically do not specifically target parents of children with ASD. Recently, a new addition to the IY suite of programmes known as the IY Autistic Spectrum and Language Delays (IY-ASLD) parent programme was developed. The main aims of the present study are to examine the feasibility of delivering this programme within child health services and to provide initial evidence for effectiveness and economic costs. Methods and analysis The Parenting for Autism, Language, And Communication Evaluation Study (PALACES) trial is a pragmatic, multicentre, pilot randomised controlled trial comparing the IY-ASLD programme with a wait-list control condition. 72 parents of children with ASD (aged 3–8 years) will be randomly allocated to either the intervention or control condition. Data will be collected prior to randomisation and 6 months postrandomisation for all families. Families in the intervention condition only will also be followed up at 12 and 18 months postrandomisation. This study will provide initial evidence of effectiveness for the newly developed IY-ASLD parenting programme. It will also add to the limited economic evidence for an intervention targeting parents of children with ASD and provide longer term data, an important component for evaluations of parenting programmes. Ethics and dissemination Approval for the study was granted by the Research Ethics Committee at the School of Psychology, Bangor University (reference number: 2016–15768) and the North Wales Research Ethics Committee, UK (reference number: 16/WA/0224). The findings will be disseminated through research conferences and peer

  12. Rationale and protocol for using a smartphone application to study autism spectrum disorders: SMARTAUTISM

    PubMed Central

    Bonnot, Olivier; Bonneau, Dominique; Doudard, Aude; Duverger, Philippe

    2016-01-01

    Introduction Longitudinal studies on the evolution of autism spectrum disorder (ASD) symptoms are limited and have primarily used repeated measurements performed several months apart. However, measurements of changes in everyday life should more closely reflect the ‘real life’ of the patient and his or her family. We propose to study the child's ASD symptoms and their effect on the quality of life, psychological status and anxiety of the child's parents over a 6-month period using SMARTAUTISM, a smartphone application. Method and analysis This is a prospective, longitudinal, exploratory, open study with a 6-month follow-up period. Data will be recorded longitudinally over multiple weeks under natural conditions. The factors affecting the quality of life and anxiety of parents of children with ASD and the children's functional symptoms will be examined, and the feasibility of using a smartphone application designed for parents of ASD patients will be assessed. Primary objective: Explore the evolution of a child's behaviour over 6 months and the (psychological and social) effects of these changes on the family. Secondary objective: Assess the feasibility of our application by examining the filling rate and application usage by parents for 6 months. 100 families containing 1 child diagnosed with ASD will be included. At baseline, sociodemographic, psychiatric and medical data will be recorded. The correlations of the general epidemiological variables (primary outcome measure) will be evaluated via multivariate analysis. The application filling rate (relative to the ideal filling rate) will be used to assess the feasibility of the application (secondary outcome measure). Ethics and dissemination The SMARTAUTISM study has the approval of the local ethics committee, and data security will be ensured via the use of encryption and a secure medical server. The use of this application will be proposed at autism resource centres across France. PMID:27881525

  13. Life after prostate cancer diagnosis: protocol for a UK-wide patient-reported outcomes study

    PubMed Central

    Downing, Amy; Wright, Penny; Wagland, Richard; Watson, Eila; Kearney, Therese; Mottram, Rebecca; Allen, Majorie; Cairnduff, Victoria; McSorley, Oonagh; Butcher, Hugh; Hounsome, Luke; Donnelly, Conan; Selby, Peter; Kind, Paul; Cross, William; Catto, James W H; Huws, Dyfed; Brewster, David H; McNair, Emma; Matheson, Lauren; Rivas, Carol; Nayoan, Johana; Horton, Mike; Corner, Jessica; Verne, Julia; Gavin, Anna; Glaser, Adam W

    2016-01-01

    Background Prostate cancer and its treatment may impact physically, psychologically and socially; affecting the health-related quality of life of men and their partners/spouses. The Life After Prostate Cancer Diagnosis (LAPCD) study is a UK-wide patient-reported outcomes study which will generate information to improve the health and well-being of men with prostate cancer. Methods and analysis Postal surveys will be sent to prostate cancer survivors (18–42 months postdiagnosis) in all 4 UK countries (n=∼70 000). Eligible men will be identified and/or verified through cancer registration systems. Men will be surveyed twice, 12 months apart, to explore changes in outcomes over time. Second, separate cohorts will be surveyed once and the design will include evaluation of the acceptability of online survey tools. A comprehensive patient-reported outcome measure has been developed using generic and specific instruments with proven psychometric properties and relevance in national and international studies. The outcome data will be linked with administrative health data (eg, treatment information from hospital data). To ensure detailed understanding of issues of importance, qualitative interviews will be undertaken with a sample of men who complete the survey across the UK (n=∼150) along with a small number of partners/spouses (n=∼30). Ethics and dissemination The study has received the following approvals: Newcastle and North Tyneside 1 Research Ethics Committee (15/NE/0036), Health Research Authority Confidentiality Advisory Group (15/CAG/0110), NHS Scotland Public Benefit and Privacy Panel (0516-0364), Office of Research Ethics Northern Ireland (16/NI/0073) and NHS R&D approval from Wales, Scotland and Northern Ireland. Using traditional and innovative methods, the results will be made available to men and their partners/spouses, the funders, the NHS, social care, voluntary sector organisations and other researchers. PMID:27927667

  14. Study protocol for a randomised controlled trial of invasive versus conservative management of primary spontaneous pneumothorax

    PubMed Central

    Brown, Simon G A; Ball, Emma L; Perrin, Kyle; Read, Catherine A; Asha, Stephen E; Beasley, Richard; Egerton-Warburton, Diana; Jones, Peter G; Keijzers, Gerben; Kinnear, Frances B; Kwan, Ben C H; Lee, Y C Gary; Smith, Julian A; Summers, Quentin A; Simpson, Graham

    2016-01-01

    Introduction Current management of primary spontaneous pneumothorax (PSP) is variable, with little evidence from randomised controlled trials to guide treatment. Guidelines emphasise intervention in many patients, which involves chest drain insertion, hospital admission and occasionally surgery. However, there is evidence that conservative management may be effective and safe, and it may also reduce the risk of recurrence. Significant questions remain regarding the optimal initial approach to the management of PSP. Methods and analysis This multicentre, prospective, randomised, open label, parallel group, non-inferiority study will randomise 342 participants with a first large PSP to conservative or interventional management. To maintain allocation concealment, randomisation will be performed in real time by computer and stratified by study site. Conservative management will involve a period of observation prior to discharge, with intervention for worsening symptoms or physiological instability. Interventional treatment will involve insertion of a small bore drain. If drainage continues after 1 hour, the patient will be admitted. If drainage stops, the drain will be clamped for 4 hours. The patient will be discharged if the lung remains inflated. Otherwise, the patient will be admitted. The primary end point is the proportion of participants with complete lung re-expansion by 8 weeks. Secondary end points are as follows: days in hospital, persistent air leak, predefined complications and adverse events, time to resolution of symptoms, and pneumothorax recurrence during a follow-up period of at least 1 year. The study has 95% power to detect an absolute non-inferiority margin of 9%, assuming 99% successful expansion at 8 weeks in the invasive treatment arm. The primary analysis will be by intention to treat. Ethics and dissemination Local ethics approval has been obtained for all sites. Study findings will be disseminated by publication in a high

  15. The effect of a cadence retraining protocol on running biomechanics and efficiency: a pilot study.

    PubMed

    Hafer, Jocelyn F; Brown, Allison M; deMille, Polly; Hillstrom, Howard J; Garber, Carol Ewing

    2015-01-01

    Many studies have documented the association between mechanical deviations from normal and the presence or risk of injury. Some runners attempt to change mechanics by increasing running cadence. Previous work documented that increasing running cadence reduces deviations in mechanics tied to injury. The long-term effect of a cadence retraining intervention on running mechanics and energy expenditure is unknown. This study aimed to determine if increasing running cadence by 10% decreases running efficiency and changes kinematics and kinetics to make them less similar to those associated with injury. Additionally, this study aimed to determine if, after 6 weeks of cadence retraining, there would be carryover in kinematic and kinetic changes from an increased cadence state to a runner's preferred running cadence without decreased running efficiency. We measured oxygen uptake, kinematic and kinetic data on six uninjured participants before and after a 6-week intervention. Increasing cadence did not result in decreased running efficiency but did result in decreases in stride length, hip adduction angle and hip abductor moment. Carryover was observed in runners' post-intervention preferred running form as decreased hip adduction angle and vertical loading rate.

  16. The ANIBES Study on Energy Balance in Spain: design, protocol and methodology.

    PubMed

    Ruiz, Emma; Ávila, José Manuel; Castillo, Adrián; Valero, Teresa; del Pozo, Susana; Rodriguez, Paula; Bartrina, Javier Aranceta; Gil, Ángel; González-Gross, Marcela; Ortega, Rosa M; Serra-Majem, Lluis; Varela-Moreiras, Gregorio

    2015-02-04

    Energy Balance (EB) is an important topic to understand how an imbalance in its main determinants (energy intake and consumption) may lead to inappropriate weight gain, considered to be "dynamic" and not "static". There are no studies to evaluate EB in Spain, and new technologies reveal themselves as key tools to solve common problems to precisely quantify energy consumption and expenditure at population level. The overall purpose of the ANIBES ("Anthropometry, Intake and Energy Balance") Study was to carry out an accurate updating of food and beverage intake, dietary habits/behaviour and anthropometric data of the Spanish population (9-75 years, n=2009), as well as the energy expenditure and physical activity patterns. Anthropometry measurements (weight, height, body mass index, waist circumference, % body fat, % body water) were obtained; diet was evaluated throughout a three-day dietary record (tablet device) accompanied by a 24 h-dietary recall; physical activity was quantified by questionnaire and accelerometers were also employed. Finally, information about perception and understanding of several issues related to EB was also obtained. The ANIBES study will contribute to provide valuable useful data to inform food policy planning, food based dietary guidelines development and other health oriented actions in Spain.

  17. Laparoscopic versus open peritoneal dialysis catheter insertion, the LOCI-trial: a study protocol

    PubMed Central

    2011-01-01

    Background Peritoneal dialysis (PD) is an effective treatment for end-stage renal disease. It allows patients more freedom to perform daily activities compared to haemodialysis. Key to successful PD is the presence of a well-functioning dialysis catheter. Several complications, such as in- and outflow obstruction, peritonitis, exit-site infections, leakage and migration, can lead to catheter removal and loss of peritoneal access. Currently, different surgical techniques are in practice for PD-catheter placement. The type of insertion technique used may greatly influence the occurrence of complications. In the literature, up to 35% catheter failure has been described when using the open technique and only 13% for the laparoscopic technique. However, a well-designed randomized controlled trial is lacking. Methods/Design The LOCI-trial is a multi-center randomized controlled, single-blind trial (pilot). The study compares the laparoscopic with the open technique for PD catheter insertion. The primary objective is to determine the optimum placement technique in order to minimize the incidence of catheter malfunction at 6 weeks postoperatively. Secondary objectives are to determine the best approach to optimize catheter function and to study the quality of life at 6 months postoperatively comparing the two operative techniques. Discussion This study will generate evidence on any benefits of laparoscopic versus open PD catheter insertion. Trial registration Dutch Trial Register NTR2878 PMID:22185091

  18. Efficacy and safety of acupuncture for chronic dizziness: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Dizziness is one of the most challenging symptoms in medicine. No medication for dizziness in current use has well-established curative or prophylactic value or is suitable for long-term palliative use. Unconventional remedies, such as acupuncture, should be considered and scientifically evaluated. However, there has been relatively little evidence in randomized controlled clinical trials on acupuncture to treat chronic dizziness. The aim of our study is to evaluate the efficacy and safety of acupuncture in patients with dizziness. Methods/Design This trial is a randomized, single-blind, controlled study. A total of 80 participants will be randomly assigned to two treatment groups receiving acupuncture and sham acupuncture treatment, respectively, for 4 weeks. The primary outcome measures are the Dizziness Handicap Inventory (DHI) and the Vertigo Symptom Scale (VSS). Treatment will be conducted over a period of 4 weeks, at a frequency of two sessions per week. The assessment is at baseline (before treatment initiation), 4 weeks after the first acupuncture session, and 8 weeks after the first acupuncture session. Discussion The results from this study will provide clinical evidence on the efficacy and safety of acupuncture in patients with chronic dizziness. Trial registration International Standard Randomized Controlled Trial Number Register: ISRCTN52695239 PMID:24330810

  19. A protocol and pilot study for managing fibromyalgia with yoga and meditation.

    PubMed

    Hennard, Janet

    2011-01-01

    Fibromyalgia is a chronic syndrome characterized by widespread pain, sleep disturbance, stiffness, fatigue, headache, and mood disorders. Recent research has resulted in an improved understanding of fibromyalgia and its possible causes. This article highlights some of the current research, discusses a strategy for using yoga and meditation as a therapy for fibromyalgia sufferers, and presents the results of a preliminary 8-week study using yoga and meditation to help manage fibromyalgia symptoms. The study of 11 participants found significant improvement in the overall health status of the participants and in symptoms of stiffness, anxiety, and depression. Significant improvements were also seen in the reported number of days "felt good" and number of days "missed work" because of fibromyalgia. Nonsignificant improvements were seen in measures of pain, fatigue, and how one felt in the morning. Effect sizes were medium to large for most tested areas. This study supports the benefits of yoga and meditation for individuals with fibromyalgia and encourages further research to explore their use as standard therapies for fibromyalgia.

  20. Epidemiological Study of Sepsis in China: Protocol of a Cross-sectional Survey

    PubMed Central

    Yang, Yi; Xie, Jian-Feng; Yu, Kai-Jiang; Yao, Chen; Li, Jian-Guo; Guan, Xiang-Dong; Yan, Jing; Ma, Xiao-Chun; Kang, Yan; Yang, Cong-Shan; Yao, Xiao-Qing; Shang, Hong-Cai; Qiu, Hai-Bo

    2016-01-01

    Background: Sepsis is the leading cause of death among critically ill patients. Herein, we conducted a national survey to provide data on epidemiology and treatment of sepsis in the clinical practice in China, which has no detailed epidemiological data available on sepsis. Methods: This was a prospective cross-sectional survey from December 1, 2015 to January 31, 2016 in all provinces/municipalities of the mainland of China. The primary outcome of this study was the incidence of sepsis, and the secondary outcome was its etiology in China. Patients with sepsis admitted to the Intensive Care Units were included in this study. The demographic, physiological, bacteriological, and therapeutic data of these patients were recorded. The incidence of sepsis was estimated using the data from the sixth census in China, reported by the Chinese National Health and Family Planning Commission and the National Bureau of Statistics as the standard population. The independent risk factors for increased mortality from sepsis were calculated. Conclusions: This study indicated the incidence and outcome of sepsis in China. It also showed the most common etiology of different sites and types of infection, which could guide empiric antibiotic therapy. Moreover, it provided information on the independent risk factors for increased mortality due to sepsis. The findings provide evidence to guide clinical management and may help improve the outcome in septic patients. Trial Registration: ClinicalTrials.gov, NCT02448472; https://clinicaltrials.gov/show/NCT02448472. PMID:27958229

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed

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

    2016-01-01

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

  3. The ANIBES Study on Energy Balance in Spain: Design, Protocol and Methodology

    PubMed Central

    Ruiz, Emma; Ávila, José Manuel; Castillo, Adrián; Valero, Teresa; del Pozo, Susana; Rodriguez, Paula; Bartrina, Javier Aranceta; Gil, Ángel; González-Gross, Marcela; Ortega, Rosa M.; Serra-Majem, Lluis; Varela-Moreiras, Gregorio

    2015-01-01

    Energy Balance (EB) is an important topic to understand how an imbalance in its main determinants (energy intake and consumption) may lead to inappropriate weight gain, considered to be “dynamic” and not “static”. There are no studies to evaluate EB in Spain, and new technologies reveal themselves as key tools to solve common problems to precisely quantify energy consumption and expenditure at population level. The overall purpose of the ANIBES (“Anthropometry, Intake and Energy Balance”) Study was to carry out an accurate updating of food and beverage intake, dietary habits/behaviour and anthropometric data of the Spanish population (9–75 years, n = 2009), as well as the energy expenditure and physical activity patterns. Anthropometry measurements (weight, height, body mass index, waist circumference, % body fat, % body water) were obtained; diet was evaluated throughout a three-day dietary record (tablet device) accompanied by a 24 h-dietary recall; physical activity was quantified by questionnaire and accelerometers were also employed. Finally, information about perception and understanding of several issues related to EB was also obtained. The ANIBES study will contribute to provide valuable useful data to inform food policy planning, food based dietary guidelines development and other health oriented actions in Spain. PMID:25658237

  4. Recognising the differences in the nurse consultant role across context: a study protocol

    PubMed Central

    2014-01-01

    Background The advanced practice role of the Nurse Consultant is unique in its capacity to provide clinical leadership across a range of contexts. However, the Nurse Consultant role has been plagued with confusion due to lack of clarity over function and appropriateness for purpose within health organisations across contexts. Changing health service delivery models are driving the emergence of new nursing roles, further clouding the waters related to role positioning and purpose. There is an urgent need for evidence of impact and demonstration of how Nurse Consultants contribute to health care outcomes. This study aims to gain a clearer understanding of the Nurse Consultant role and its impact in metropolitan and rural New South Wales (NSW) Australia. Design The proposed study employs a sequential mixed method design, underpinned by Realistic Evaluation, to explore how Nurse Consultants contribute to organisational outcomes. The ‘context – mechanism – outcome’ approach of realistic evaluation provides a sound framework to examine the complex, diverse and multifaceted nature of the Nurse Consultant’s role. Method Participants will be stakeholders, recruited across a large Local Health District in NSW, comprising rural and metropolitan services. A modified and previously validated survey will be used providing information related to role characteristics, patterns and differences across health context. Focus groups with Nurse Consultant’s explore issues highlighted in the survey data. Focus groups with other clinicians, policy makers and managers will help to achieve understanding of how the role is viewed and enacted across a range of groups and contexts. Discussion Lack of role clarity is highlighted extensively in international and Australian studies examining the role of the Nurse Consultant. Previous studies failed to adequately examine the role in the context of integrated and complex health services or to examine the role in detail. Such examination

  5. Psychological advocacy toward healing (PATH): study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Domestic violence and abuse (DVA), defined as threatening behavior or abuse by adults who are intimate partners or family members, is a key public health and clinical priority. The prevalence of DVA in the United Kingdom and worldwide is high, and its impact on physical and mental health is detrimental and persistent. There is currently little support within healthcare settings for women experiencing DVA. Psychological problems in particular may be difficult to manage outside specialist services, as conventional forms of therapy such as counseling that do not address the violence may be ineffective or even harmful. The aim of this study is to assess the overall effectiveness and cost-effectiveness of a novel psychological intervention tailored specifically for survivors of DVA and delivered by domestic violence advocates based in third-sector organizations. Methods and study design This study is an open, pragmatic, parallel group, individually randomized controlled trial. Women ages 16 years and older experiencing domestic violence are being enrolled and randomly allocated to receive usual DVA agency advocacy support (control) or usual DVA agency support plus psychological intervention (intervention). Those in the intervention group will receive eight specialist psychological advocacy (SPA) sessions weekly or fortnightly, with two follow-up sessions, 1 month and then 3 months later. This will be in addition to any advocacy support sessions each woman receives. Women in the control group will receive usual DVA agency support but no additional SPA sessions. The aim is to recruit 250 women to reach the target sample size. The primary outcomes are psychological well-being and depression severity at 1 yr from baseline, as measured by the Clinical Outcomes in Routine Evaluation–Outcome Measure (CORE-OM) and the Patient Health Questionnaire (PHQ-9), respectively. Secondary outcome measures include anxiety, posttraumatic stress, severity and frequency of abuse

  6. Perivascular Adipose Tissue Inflammation and Coronary Artery Disease: An Autopsy Study Protocol

    PubMed Central

    Farias-Itao, Daniela Souza; Pasqualucci, Carlos Augusto; Nishizawa, Aline; Silva, Luiz Fernando Ferraz; Campos, Fernanda Marinho; da Silva, Karen Cristina Souza; Leite, Renata Elaine Paraizo; Grinberg, Lea Tenenholz; Ferretti-Rebustini, Renata Eloah Lucena; Jacob Filho, Wilson

    2016-01-01

    Background Perivascular adipose tissue (PAT) inflammation may have a role in coronary artery disease (CAD) pathophysiology. However, most evidence has come from samples obtained during surgical procedures that may imply in some limitations. Moreover, the role of B lymphocytes and inflammation in PAT that is adjacent to unstable atheroma plaques has not been investigated in humans using morphometric measurements. Objective The objective of this study is to investigate the inflammation in PAT, subcutaneous, and perirenal adipose tissues (SAT and PrAT) among chronic CAD, acute CAD, and control groups in an autopsy study. Methods Heart, SAT, and PrAT samples are collected from autopsied subjects in a general autopsy service, with the written informed consent of the next-of-kin (NOK). Sociodemographic and clinical data are obtained from a semistructure interview with the NOK. Coronary arteries are dissected and PAT are removed. Sections with the greatest arterial obstruction or unstable plaques, and the local with absence of atherosclerosis in all coronary arteries are sampled. PAT are represented adjacent to these fragments. Adipose tissues are fixed in 4% buffered paraformaldehyde solution and analyzed immunohistochemically for macrophages (CD68), macrophage polarization (CD11c for proinflammatory and CD206 for anti-inflammatory), B lymphocytes (CD20), and T lymphocytes (CD3). Slides will be scanned, and inflammatory cells will be quantified in 20 random fields. Participants will be categorized in CAD groups, after morphometric measurement of arterial obstruction and plaque composition analysis in accordance with American Heart Association classification. Three study groups will be investigated: acute CAD (at least one unstable plaque); chronic CAD (≥50% arterial obstruction); and controls (<50% arterial obstruction). Inflammatory cells in PAT, SAT, and PrAT will be counted and compared between groups using multivariate linear regression, adjusted for age, body mass

  7. MHealth to Improve Measles Immunization in Guinea-Bissau: Study Protocol for a Randomized Controlled Trial

    PubMed Central

    Ravn, Henrik; Batista, Celso Soares Pereira; Rodrigues, Amabelia

    2016-01-01

    Background Recent studies have revealed a low measles vaccination (MV) rate in the Republic of Guinea-Bissau (West Africa) that has not increased in accordance with the increasing coverage of other vaccinations. Measles is the deadliest of all childhood rash/fever illnesses and spreads easily, implying that if the vaccination coverage is declining there is a significant risk of new measles outbreaks [27]. Meanwhile, mobile health (mHealth; the use of mobile phones for health interventions) has generated much enthusiasm, and shown potential in improving health service delivery in other contexts. Objective The aim of this study is to evaluate the efficiency of mHealth as a tool for improving MV coverage while contributing to the mHealth evidence base. Methods This study will take place at three health centers in different regions of Guinea-Bissau. Participants, defined as mothers of the children receiving the MV, will be enrolled when they arrive with their children at the health center to receive the Bacillus Calmette-Guérin vaccination, usually within one month of the child’s birth. Enrolment will continue until a study population of 990 children has been reached. The participants will be randomly assigned to a control arm or one of two intervention arms. Each of the three groups will have 330 participants, distributed equally between health centers. Participants in the first intervention arm will receive a scheduled short message service (SMS) text message reminding them of the MV. Participants in the second intervention arm will receive a voice call in addition to the SMS message, while the control arm will receive no interventions. The MV is scheduled to be administered at 9 months of age. Although the vaccine would still be effective after 12 months, local policy in Guinea-Bissau prevents children aged >12 months from receiving the vaccination, and thus the study will follow-up with participants after the children reach 12 months of age. Children who have

  8. Assessment of the ability of wheelchair subjects with spinal cord injury to perform a specific protocol of shoulder training: a pilot study

    PubMed Central

    Merolla, Giovanni; Dellabiancia, Fabio; Filippi, Maria Vittoria; De Santis, Elisa; Alpi, Daniele; Magrini, Paola; Porcellini, Giuseppe

    2014-01-01

    Summary Background: a regular program of exercises in subjects with spinal cord injury (SCI) can contribute to reduce the risk of upper extremities injuries. Methods: in this prospective laboratory study we tested the hypothesis that a training machine developed for able-body users is suitable for a shoulder training protocol in 11 paraplegic subjects with SCI. Overall subjects were assessed with the SCIM III, CS, DASH and standard shoulder examination. We set a protocol of shoulder exercises performed with a training machine. Overall subjects were able to perform the protocol but 2 did not complete the exercises n° 6 and 7. The position of the wheelchair during each exercise was recorded. Wheelchair position/loading level were significantly correlated with the protocol n° 2, 3 and 5 as well as BMI/loading level for the exercises n° 5 and 9 and age/loading level for the exercise n° 7. Clinical scores were neither correlated with loading nor with anthropometric data. Results/Conclusions: from the analysis of data collected in this study arised that: 1) the training machine needs some adjustments for paraplegic subjects, 2) the training protocol was appropriate except for the exercises needing a torso-rotation and 3) the template for wheelchair position may be a valid guide for an optimal paraplegic shoulder training. PMID:25332931

  9. Comparison of the BPLab® sphygmomanometer for ambulatory blood pressure monitoring with mercury sphygmomanometry in pregnant women: validation study according to the British Hypertension Society protocol

    PubMed Central

    Dorogova, Inna V; Panina, Elena S

    2015-01-01

    The purpose of this study was to validate the automated BPLab® sphygmomanometer for ambulatory blood pressure monitoring (ABPM) in pregnant women according to Part II of the 1993 British Hypertension Society protocol. Pregnant women attending the antenatal clinic were randomly asked to participate (n=30). The BPLab sphygmomanometer was tested on pregnant women in this study and achieved A/A ratings according to the BHS protocol when compared with the “gold” standard of mercury sphygmomanometry. The device can therefore be recommended for use in pregnancy. PMID:25926739

  10. Bioprinting cell-laden matrigel for radioprotection study of liver by pro-drug conversion in a dual-tissue microfluidic chip.

    PubMed

    Snyder, J E; Hamid, Q; Wang, C; Chang, R; Emami, K; Wu, H; Sun, W

    2011-09-01

    The objective of this paper is to introduce a novel cell printing and microfluidic system to serve as a portable ground model for the study of drug conversion and radiation protection of living liver tissue analogs. The system is applied to study behavior in ground models of space stress, particularly radiation. A microfluidic environment is engineered by two cell types to prepare an improved higher fidelity in vitro micro-liver tissue analog. Cell-laden Matrigel printing and microfluidic chips were used to test radiation shielding to liver cells by the pro-drug amifostine. In this work, the sealed microfluidic chip regulates three variables of interest: radiation exposure, anti-radiation drug treatment and single- or dual-tissue culture environments. This application is intended to obtain a scientific understanding of the response of the multi-cellular biological system for long-term manned space exploration, disease models and biosensors.

  11. Internet-Based Cognitive Behavior Therapy for Procrastination: Study Protocol for a Randomized Controlled Trial

    PubMed Central

    Rozental, Alexander

    2013-01-01

    Background Procrastination, to voluntarily delay an intended course of action despite expecting to be worse-off for the delay, is a persistent behavior pattern that can cause major psychological suffering. Approximately half of the student population and 15%-20% of the adult population are presumed having substantial difficulties due to chronic and recurrent procrastination in their everyday life. However, preconceptions and a lack of knowledge restrict the availability of adequate care. Cognitive behavior therapy (CBT) is often considered treatment of choice, although no clinical trials have previously been carried out. Objective The aim of this study will be to test the effects of CBT for procrastination, and to investigate whether it can be delivered via the Internet. Methods Participants will be recruited through advertisements in newspapers, other media, and the Internet. Only people residing in Sweden with access to the Internet and suffering from procrastination will be included in the study. A randomized controlled trial with a sample size of 150 participants divided into three groups will be utilized. The treatment group will consist of 50 participants receiving a 10-week CBT intervention with weekly therapist contact. A second treatment group with 50 participants receiving the same treatment, but without therapist contact, will also be employed. The intervention being used for the current study is derived from a self-help book for procrastination written by one of the authors (AR). It includes several CBT techniques commonly used for the treatment of procrastination (eg, behavioral activation, behavioral experiments, stimulus control, and psychoeducation on motivation and different work methods). A control group consisting of 50 participants on a wait-list control will be used to evaluate the effects of the CBT intervention. For ethical reasons, the participants in the control group will gain access to the same intervention following the 10-week treatment

  12. Network coordination following discharge from psychiatric inpatient treatment: a study protocol

    PubMed Central

    2013-01-01

    Background Inadequate discharge planning following inpatient stays is a major issue in the provision of a high standard of care for patients who receive psychiatric treatment. Studies have shown that half of patients who had no pre-discharge contact with outpatient services do not keep their first outpatient appointment. Additionally, discharged patients who are not well linked to their outpatient care networks are at twice the risk of re-hospitalization. The aim of this study is to investigate if the Post-Discharge Network Coordination Program at ipw has a demonstrably significant impact on the frequency and duration of patient re-hospitalization. Subjects are randomly assigned to either the treatment group or to the control group. The treatment group participates in the Post-Discharge Network Coordination Program. The control group receives treatment as usual with no additional social support. Further outcome variables include: social support, change in psychiatric symptoms, quality of life, and independence in daily functioning. Methods/design The study is conducted as a randomized controlled trial. Subjects are randomly assigned to either the control group or to the treatment group. Computer generated block randomization is used to assure both groups have the same number of subjects. Stratified block randomization is used for the psychiatric diagnosis of ICD-10, F1. Approximately 160 patients are recruited in two care units at Psychiatrie-Zentrum Hard Embrach and two care units at Klinik Schlosstal Winterthur. Discussion The proposed post-discharge network coordination program intervenes during the critical post-discharge period. It focuses primarily on promoting the integration of the patients into their social networks, and additionally to coordinating outpatient care and addressing concerns of daily life. Trial registration ISRCTN: ISRCTN58280620 PMID:24007198

  13. Active buildings: modelling physical activity and movement in office buildings. An observational study protocol

    PubMed Central

    Smith, Lee; Ucci, Marcella; Marmot, Alexi; Spinney, Richard; Laskowski, Marek; Sawyer, Alexia; Konstantatou, Marina; Hamer, Mark; Ambler, Gareth; Wardle, Jane; Fisher, Abigail

    2013-01-01

    Introduction Health benefits of regular participation in physical activity are well documented but population levels are low. Office layout, and in particular the number and location of office building destinations (eg, print and meeting rooms), may influence both walking time and characteristics of sitting time. No research to date has focused on the role that the layout of the indoor office environment plays in facilitating or inhibiting step counts and characteristics of sitting time. The primary aim of this study was to investigate associations between office layout and physical activity, as well as sitting time using objective measures. Methods and analysis Active buildings is a unique collaboration between public health, built environment and computer science researchers. The study involves objective monitoring complemented by a larger questionnaire arm. UK office buildings will be selected based on a variety of features, including office floor area and number of occupants. Questionnaires will include items on standard demographics, well-being, physical activity behaviour and putative socioecological correlates of workplace physical activity. Based on survey responses, approximately 30 participants will be recruited from each building into the objective monitoring arm. Participants will wear accelerometers (to monitor physical activity and sitting inside and outside the office) and a novel tracking device will be placed in the office (to record participant location) for five consecutive days. Data will be analysed using regression analyses, as well as novel agent-based modelling techniques. Ethics and dissemination The results of this study will be disseminated through peer-reviewed publications and scientific presentations. Ethical approval was obtained through the University College London Research Ethics Committee (Reference number 4400/001). PMID:24227873

  14. Congenital transmission of Trypanosoma cruzi in Argentina, Honduras, and Mexico: study protocol

    PubMed Central

    2013-01-01

    Background Trypanosoma cruzi has been divided into Discrete Typing Units I and non-I (II-VI). T. cruzi I is predominant in Mexico and Central America, while non-I is predominant in most of South America, including Argentina. Little is known about congenital transmission of T. cruzi I. The specific aim of this study is to determine the rate of congenital transmission of T. cruzi I compared to non-I. Methods/design We are conducting a prospective study to enroll at delivery, 10,000 women in Argentina, 7,500 women in Honduras, and 13,000 women in Mexico. We are measuring transmitted maternal T. cruzi antibodies by performing two rapid tests in cord blood (Stat-Pak, Chembio, Medford, New York, and Trypanosoma Detect, InBios, Seattle, Washington). If at least one of the results is positive, we are identifying infants who are congenitally infected by performing parasitological examinations on cord blood and at 4–8 weeks, and serological follow-up at 10 months. Serological confirmation by ELISA (Wiener, Rosario, Argentina) is performed in cord and maternal blood, and at 10 months. We also are performing T. cruzi standard PCR, real-time quantitative PCR and genotyping on maternal venous blood and on cord blood, and serological examinations on siblings. Data are managed by a Data Center in Montevideo, Uruguay. Data are entered online at the sites in an OpenClinica data management system, and digital pictures of data forms are sent to the Data Center for quality control. Weekly reports allow for rapid feedback to the sites. Trial registration Observational study with ClinicalTrials.gov Identifier NCT01787968 PMID:24119247

  15. The carotid plaque imaging in acute stroke (CAPIAS) study: protocol and initial baseline data

    PubMed Central

    2013-01-01

    Background In up to 30% of patients with ischemic stroke no definite etiology can be established. A significant proportion of cryptogenic stroke cases may be due to non-stenosing atherosclerotic plaques or low grade carotid artery stenosis not fulfilling common criteria for atherothrombotic stroke. The aim of the CAPIAS study is to determine the frequency, characteristics, clinical and radiological long-term consequences of ipsilateral complicated American Heart Association lesion type VI (AHA-LT VI) carotid artery plaques in patients with cryptogenic stroke. Methods/Design 300 patients (age >49 years) with unilateral DWI-positive lesions in the anterior circulation and non- or moderately stenosing (<70% NASCET) internal carotid artery plaques will be enrolled in the prospective multicenter study CAPIAS. Carotid plaque characteristics will be determined by high-resolution black-blood carotid MRI at baseline and 12 month follow up. Primary outcome is the prevalence of complicated AHA-LT VI plaques in cryptogenic stroke patients ipsilateral to the ischemic stroke compared to the contralateral side and to patients with defined stroke etiology. Secondary outcomes include the association of AHA-LT VI plaques with the recurrence rates of ischemic events up to 36 months, rates of new ischemic lesions on cerebral MRI (including clinically silent lesions) after 12 months and the influence of specific AHA-LT VI plaque features on the progression of atherosclerotic disease burden, on specific infarct patterns, biomarkers and aortic arch plaques. Discussion CAPIAS will provide important insights into the role of non-stenosing carotid artery plaques in cryptogenic stroke. The results might have implications for our understanding of stroke mechanism, offer new diagnostic options and provide the basis for the planning of targeted interventional studies. Trial Registration NCT01284933 PMID:24330333

  16. Communicating the Neuroscience of Psychopathy and Its Influence on Moral Behavior: Protocol of Two Experimental Studies

    PubMed Central

    Blakey, Robert; Askelund, Adrian D.; Boccanera, Matilde; Immonen, Johanna; Plohl, Nejc; Popham, Cassandra; Sorger, Clarissa; Stuhlreyer, Julia

    2017-01-01

    Neuroscience has identified brain structures and functions that correlate with psychopathic tendencies. Since psychopathic traits can be traced back to physical neural attributes, it has been argued that psychopaths are not truly responsible for their actions and therefore should not be blamed for their psychopathic behaviors. This experimental research aims to evaluate what effect communicating this theory of psychopathy has on the moral behavior of lay people. If psychopathy is blamed on the brain, people may feel less morally responsible for their own psychopathic tendencies and therefore may be more likely to display those tendencies. An online study will provide participants with false feedback about their psychopathic traits supposedly based on their digital footprint (i.e., Facebook likes), thus classifying them as having either above-average or below-average psychopathic traits and describing psychopathy in cognitive or neurobiological terms. This particular study will assess the extent to which lay people are influenced by feedback regarding their psychopathic traits, and how this might affect their moral behavior in online tasks. Public recognition of these potential negative consequences of neuroscience communication will also be assessed. A field study using the lost letter technique will be conducted to examine lay people’s endorsement of neurobiological, as compared to cognitive, explanations of criminal behavior. This field and online experimental research could inform the future communication of neuroscience to the public in a way that is sensitive to the potential negative consequences of communicating such science. In particular, this research may have implications for the future means by which neurobiological predictors of offending can be safely communicated to offenders. PMID:28352238

  17. Development of the Brussels Infant and Toddler Stool Scale (‘BITSS’): protocol of the study

    PubMed Central

    Vandenplas, Yvan; Szajewska, Hania; Benninga, Marc; Di Lorenzo, Carlo; Dupont, Christophe; Faure, Christophe; Miqdadi, Mohamed; Osatakul, Seksit; Ribes-Konickx, Carmen; Saps, Miguel; Shamir, Raanan; Staiano, Annamaria

    2017-01-01

    Introduction The Bristol Stool Form Scale (BSS) which consists of 7 photographs of different stool forms allows assessment of stool consistency (scale 1 for hard lumps to scale 7 for watery stools), in an objective manner in adults. The BSS is also sometimes used to characterise the stools of infants and young children. Despite its use, there is general agreement among paediatric gastroenterologists that the BSS is not adequate to be used in infants and young children who wear diapers; thus, a new scale specifically designed for this population is needed. Our aim is to develop a paediatric stool scale, the Brussels Infant and Toddler Stool Scale (‘BITSS’), and to evaluate the interobserver agreement of stool assessment with the BITSS between the patient's parent and healthcare providers (physicians and nurses). Methods and analysis This study has two phases. In the first phase, 11 key-opinion leaders in the field of paediatric gastroenterology representing different areas of the world selected seven coloured photographs of infants and/or young children wearing diapers to match the original descriptors of the BSS. The selected photographs were used to create a new scale in which the drawings of stools of the BSS were replaced by infant/toddlers stool photographs. In phase II, we aim at demonstrating that parents, nurses and primary healthcare physicians interpret the stool-pictures of the BITSS with a high degree of consensus and that the agreement is independent of whether it is a parent or a healthcare provider. Interobserver variability of stool assessment with the BITSS between the patient's parent and healthcare providers will be assessed. Ethics and dissemination The study will be approved by the Ethics Committee of the participating centres. The findings of this study will be submitted to a peer-reviewed journal. Abstracts will be submitted to national and international conferences. Trial registration number NCT02913950. PMID:28360250

  18. Measuring the relationship between interruptions, multitasking and prescribing errors in an emergency department: a study protocol

    PubMed Central

    Raban, Magdalena Z; Walter, Scott R; Douglas, Heather E; Strumpman, Dana; Mackenzie, John; Westbrook, Johanna I

    2015-01-01

    Introduction Interruptions and multitasking are frequent in clinical settings, and have been shown in the cognitive psychology literature to affect performance, increasing the risk of error. However, comparatively less is known about their impact on errors in clinical work. This study will assess the relationship between prescribing errors, interruptions and multitasking in an emergency department (ED) using direct observations and chart review. Methods and analysis The study will be conducted in an ED of a 440-bed teaching hospital in Sydney, Australia. Doctors will be shadowed at proximity by observers for 2 h time intervals while they are working on day shift (between 0800 and 1800). Time stamped data on tasks, interruptions and multitasking will be recorded on a handheld computer using the validated Work Observation Method by Activity Timing (WOMBAT) tool. The prompts leading to interruptions and multitasking will also be recorded. When doctors prescribe medication, type of chart and chart sections written on, along with the patient's medical record number (MRN) will be recorded. A clinical pharmacist will access patient records and assess the medication orders for prescribing errors. The prescribing error rate will be calculated per prescribing task and is defined as the number of errors divided by the number of medication orders written during the prescribing task. The association between prescribing error rates, and rates of prompts, interruptions and multitasking will be assessed using statistical modelling. Ethics and dissemination Ethics approval has been obtained from the hospital research ethics committee. Eligible doctors will be provided with written information sheets and written consent will be obtained if they agree to participate. Doctor details and MRNs will be kept separate from the data on prescribing errors, and will not appear in the final data set for analysis. Study results will be disseminated in publications and feedback to the ED. PMID

  19. Default options in advance directives: study protocol for a randomised clinical trial

    PubMed Central

    Gabler, Nicole B; Cooney, Elizabeth; Small, Dylan S; Troxel, Andrea B; Arnold, Robert M; White, Douglas B; Angus, Derek C; Loewenstein, George; Volpp, Kevin G; Bryce, Cindy L; Halpern, Scott D

    2016-01-01

    Introduction Although most seriously ill Americans wish to avoid burdensome and aggressive care at the end of life, such care is often provided unless patients or family members specifically request otherwise. Advance directives (ADs) were created to provide opportunities to set limits on aggressive care near life's end. This study tests the hypothesis that redesigning ADs such that comfort-oriented care is provided as the default, rather than requiring patients to actively choose it, will promote better patient-centred outcomes. Methods and analysis This multicentre trial randomises seriously ill adults to receive 1 of 3 different ADs: (1) a traditional AD that requires patients to actively choose their goals of care or preferences for specific interventions (eg, feeding tube insertion) or otherwise have their care guided by their surrogates and the prevailing societal default toward aggressive care; (2) an AD that defaults to life-extending care and receipt of life-sustaining interventions, enabling patients to opt out from such care; or (3) an AD that defaults to comfort care, enabling patients to opt into life-extending care. We seek to enrol 270 patients who return complete, legally valid ADs so as to generate sufficient power to detect differences in the primary outcome of hospital-free days (days alive and not in an acute care facility). Secondary outcomes include hospital and intensive care unit admissions, costs of care, hospice usage, decision conflict and satisfaction, quality of life, concordance of preferences with care received and bereavement outcomes for surrogates of patients who die. Ethics and dissemination This study has been approved by the Institutional Review Boards at all trial centres, and is guided by a data safety and monitoring board and an ethics advisory board. Study results will be disseminated using methods that describe the results in ways that key stakeholders can best understand and implement. Trial registration number NCT02017548

  20. Stimulant Reduction Intervention using Dosed Exercise (STRIDE) - CTN 0037: Study protocol for a randomized controlled trial

    PubMed Central

    2011-01-01

    Background There is a need for novel approaches to the treatment of stimulant abuse and dependence. Clinical data examining the use of exercise as a treatment for the abuse of nicotine, alcohol, and other substances suggest that exercise may be a beneficial treatment for stimulant abuse, with direct effects on decreased use and craving. In addition, exercise has the potential to improve other health domains that may be adversely affected by stimulant use or its treatment, such as sleep disturbance, cognitive function, mood, weight gain, quality of life, and anhedonia, since it has been shown to improve many of these domains in a number of other clinical disorders. Furthermore, neurobiological evidence provides plausible mechanisms by which exercise could positively affect treatment outcomes. The current manuscript presents the rationale, design considerations, and study design of the National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) CTN-0037 Stimulant Reduction Intervention using Dosed Exercise (STRIDE) study. Methods/Design STRIDE is a multisite randomized clinical trial that compares exercise to health education as potential treatments for stimulant abuse or dependence. This study will evaluate individuals diagnosed with stimulant abuse or dependence who are receiving treatment in a residential setting. Three hundred and thirty eligible and interested participants who provide informed consent will be randomized to one of two treatment arms: Vigorous Intensity High Dose Exercise Augmentation (DEI) or Health Education Intervention Augmentation (HEI). Both groups will receive TAU (i.e., usual care). The treatment arms are structured such that the quantity of visits is similar to allow for equivalent contact between groups. In both arms, participants will begin with supervised sessions 3 times per week during the 12-week acute phase of the study. Supervised sessions will be conducted as one-on-one (i.e., individual) sessions, although other

  1. Azithromycin for Indigenous children with bronchiectasis: study protocol for a multi-centre randomized controlled trial

    PubMed Central

    2012-01-01

    Background The prevalence of chronic suppurative lung disease (CSLD) and bronchiectasis unrelated to cystic fibrosis (CF) among Indigenous children in Australia, New Zealand and Alaska is very high. Antibiotics are a major component of treatment and are used both on a short or long-term basis. One aim of long-term or maintenance antibiotics is to reduce the frequency of acute pulmonary exacerbations and symptoms. However, there are few studies investigating the efficacy of long-term antibiotic use for CSLD and non-CF bronchiectasis among children. This study tests the hypothesis that azithromycin administered once a week as maintenance antibiotic treatment will reduce the rate of pulmonary exacerbations in Indigenous children with bronchiectasis. Methods/design We are conducting a multicentre, randomised, double-blind, placebo controlled clinical trial in Australia and New Zealand. Inclusion criteria are: Aboriginal, Torres Strait Islander, Maori or Pacific Island children aged 1 to 8 years, diagnosed with bronchiectasis (or probable bronchiectasis) with no underlying disease identified (such as CF or primary immunodeficiency), and having had at least one episode of pulmonary exacerbation in the last 12 months. After informed consent, children are randomised to receive either azithromycin (30 mg/kg once a week) or placebo (once a week) for 12–24 months from study entry. Primary outcomes are the rate of pulmonary exacerbations and time to pulmonary exacerbation determined by review of patient medical records. Secondary outcomes include length and severity of pulmonary exacerbation episodes, changes in growth, school loss, respiratory symptoms, forced expiratory volume in 1-second (FEV1; for children ≥6 years), and sputum characteristics. Safety endpoints include serious adverse events. Antibiotic resistance in respiratory bacterial pathogens colonising the nasopharynx is monitored. Data derived from medical records and clinical assessments every 3 to 4

  2. A National Surveillance Survey on Noncommunicable Disease Risk Factors: Suriname Health Study Protocol

    PubMed Central

    Smits, Christel CF; Jaddoe, Vincent WV; Hofman, Albert; Toelsie, Jerry R

    2015-01-01

    Background Noncommunicable diseases (NCDs) are the leading cause of death in low- and middle-income countries. Therefore, the surveillance of risk factors has become an issue of major importance for planning and implementation of preventive measures. Unfortunately, in these countries data on NCDs and their risk factors are limited. This also prevails in Suriname, a middle-income country of the Caribbean, with a multiethnic/multicultural population living in diverse residential areas. For these reasons, “The Suriname Health Study” was designed. Objective The main objective of this study is to estimate the prevalence of NCD risk factors, including metabolic syndrome, hypertension, and diabetes in Suriname. Differences between specific age groups, sexes, ethnic groups, and geographical areas will be emphasized. In addition, risk groups will be identified and targeted actions will be designed and evaluated. Methods In this study, several methodologies were combined. A stratified multistage cluster sample was used to select the participants of 6 ethnic groups (Hindustani, Creole, Javanese, Maroon, Chinese, Amerindians, and mixed) divided into 5 age groups (between 15 and 65 years) who live in urban/rural areas or the hinterland. A standardized World Health Organization STEPwise approach to surveillance questionnaire was adapted and used to obtain information about demographic characteristics, lifestyle, and risk factors. Physical examinations were performed to measure blood pressure, height, weight, and waist circumference. Biochemical analysis of collected blood samples evaluated the levels of glucose, high-density-lipoprotein cholesterol, total cholesterol, and triglycerides. Statistical analysis will be used to identify the burden of modifiable and unmodifiable risk factors in the aforementioned subgroups. Subsequently, tailor-made interventions will be prepared and their effects will be evaluated. Results The data as collected allow for national inference and

  3. The effectiveness of a health promotion with group intervention by clinical trial. Study protocol

    PubMed Central

    2012-01-01

    Background The promotion of health and the interventions in community health continue to be one of the pending subjects of our health system. The most prevalent health problems (cardiovascular diseases, cancer, diabetes...) are for the most part related to life habits. We propose a holistic and integral approach as the best option for tackling behavior and its determinants. The research team has elaborated the necessary educational material to realize group teaching, which we call "Health Workshops". The goal of the present study is to evaluate the effectiveness of these Health Workshops in the following terms: Health Related Quality of Life (HRQOL), incorporate and maintain a balanced diet, do physical activity regularly, maintain risk factors such as tension, weight, cholesterol within normal limits and diminish cardiovascular risk. Methods/Design Controlled and random clinical testing, comparing a group of persons who have participated in the Health Workshops with a control group of similar characteristics who have not participated in the Health Workshops. Field of study: the research is being done in Health Centers of the city of Barcelona, Spain. Population studied: The group is composed of 108 persons that are actually doing the Health Workshops, and 108 that are not and form the control group. They are assigned at random to one group or the other. Data Analysis: With Student's t-distribution test to compare the differences between numerical variables or their non parametric equivalent if the variable does not comply with the criteria of normality. (Kolmogorov-Smirnof test). Chi-square test to compare the differences between categorical variables and the Logistic Regression Model to analyze different meaningful variables by dichotomous analysis related to the intervention. Discussion The Health Workshop proposed in the present study constitutes an innovative approach in health promotion, placing the emphasis on the person's self responsibility for his/her own

  4. Factors influencing delay in the diagnosis of colorectal cancer: a study protocol

    PubMed Central

    Esteva, Magdalena; Ramos, Maria; Cabeza, Elena; Llobera, Joan; Ruiz, Amador; Pita, Salvador; Segura, Josep M; Cortés, Jose M; González-Lujan, Luis

    2007-01-01

    Background Colorectal cancer (CRC) is the second most frequent tumor in developed countries. Since survival from CRC depends mostly on disease stage at the time of diagnosis, individuals with symptoms or signs suspicious of CRC should be examined without delay. Many factors, however, intervene between symptom onset and diagnosis. This study was designed to: 1) Describe the diagnostic process of CRC from the onset of first symptoms to diagnosis and treatment. 2) Establish the time interval from initial symptoms to diagnosis and treatment, globally and considering patient's and doctors' delay, with the latter due to family physician and/or hospital services. 3) Identify the factors related to defined types of delay. 4) Assess the concordance between information included in primary health care and hospital clinical records regarding onset of first symptoms. Methods/Design Descriptive study, coordinated, with 5 participant groups of 5 different Spanish regions (Balearic Islands, Galicia, Catalunya, Aragón and Valencia Health Districts), with a total of 8 acute public hospitals and 140 primary care centers. Incident cases of CRC during the study period, as identified from pathology services at the involved hospitals. A sample size of 896 subjects has been estimated, 150 subjects for each participant group. Information will be collected through patient interviews and primary health care and hospital clinical records. Patient variables will include sociodemographic variables, family history of cancer, symptom perception, and confidence in the family physician; tumor variables will include tumor site, histological type, grade and stage; symptom variables will include date of onset, type and number of symptoms; health system variables will include number of patient contacts with family physician, type and content of the referral, hospital services attending the patient, diagnostic modalities and results; and delay intervals, including global delays and delays attributed to

  5. Advancing Migrant Access to Health Services in Europe (AMASE): Protocol for a Cross-sectional Study

    PubMed Central

    Álvarez-del Arco, Débora; Monge, Susana; Copas, Andrew J; Gennotte, Anne-Francoise; Volny-Anne, Alain; Göpel, Siri; Touloumi, Giota; Prins, Maria; Barros, Henrique; Staehelin, Cornelia; del Amo, Julia; Burns, Fiona M

    2016-01-01

    Background Migrants form a substantial proportion of the population affected by the human immunodeficiency virus (HIV) epidemic in Europe, yet HIV prevention for this population is hindered by poor understanding of access to care and of postmigration transmission dynamics. Objective We present the design and methods of the advancing Migrant Access to health Services in Europe (aMASE) study, the first European cross-cultural study focused on multiple migrant populations. It aims to identify the structural, cultural, and financial barriers to HIV prevention, diagnosis, and treatment and to determine the likely country of HIV acquisition in HIV-positive migrant populations. Methods We delivered 2 cross-sectional electronic surveys across 10 countries (Belgium, France, Germany, Greece, Italy, the Netherlands, Portugal, Spain, Switzerland, and United Kingdom). A clinic survey aimed to recruit up to 2000 HIV-positive patients from 57 HIV clinics in 9 countries. A unique study number linked anonymized questionnaire data to clinical records data (viral loads, CD4 cell counts, viral clades, etc). This questionnaire was developed by expert panel consensus and cognitively tested, and a pilot study was carried out in 2 countries. A Web-based community survey (n=1000) reached those living with HIV but not currently accessing HIV clinics, as well as HIV-negative migrants. It was developed in close collaboration with a community advisory group (CAG) made up of representatives from community organizations in 9 of the participating countries. The CAG played a key role in data collection by promoting the survey to higher-risk migrant groups (sub-Saharan Africans, Latin Americans, men who have sex with men, and people who inject drugs). The questionnaires have considerable content overlap, allowing for comparison. Questions cover ethnicity, migration, immigration status, HIV testing and treatment, health-seeking behavior, sexual risk, and drug use. The electronic questionnaires

  6. Co-Designing Mobile Apps to Assist in Clinical Nursing Education: A Study Protocol.

    PubMed

    O'Connor, Siobhan; Andrews, Tom

    2016-01-01

    Mobile applications (apps) to train health professionals is gaining momentum as the benefits of mobile learning (mLearning) are becoming apparent in complex clinical environments. However, most educational apps are generic, off-the-shelf pieces of software that do not take into consideration the unique needs of nursing students. The proposed study will apply a user-centred design process to create a tailored mobile app for nursing students to learn and apply clinical skills in practice. The app will be piloted and evaluated to understand how nursing students use mobile technology in clinical settings to support their learning and educational needs.

  7. Text Messaging to Improve Hypertension Medication Adherence in African Americans: BPMED Intervention Development and Study Protocol

    PubMed Central

    Artinian, Nancy T; Schwiebert, Loren; Yarandi, Hossein; Levy, Phillip D

    2015-01-01

    Background Hypertension (HTN) is a major public health concern in the United States, with almost 78 million Americans age 20 years and over suffering from the condition. Moreover, HTN is a key risk factor for health disease and stroke. African Americans disproportionately shoulder the burdens of HTN, with greater prevalence, disease severity, earlier onset, and more HTN-related complications than age-matched whites. Medication adherence for the treatment of HTN is poor, with estimates indicating that only about half of hypertensive patients are adherent to prescribed medication regimens. Although no single intervention for improving medication adherence has emerged as superior to others, text message medication reminders have the potential to help improve medication adherence in African Americans with uncontrolled HTN as mobile phone adoption is very high in this population. Objective The purpose of this two-phased study was to develop (Phase I) and test in a randomized controlled trial (RCT) (Phase II) a text message system, BPMED, to improve the quality of medication management through increasing medication adherence in African Americans with uncontrolled HTN. Methods In Phase I, we recruited 16 target end-users from a primary care clinic, to assist in the development of BPMED through participating in one of three focus groups. Focus groups sought to gain patient perspectives on HTN, medication adherence, mobile phone use, and the use of text messaging to support medication adherence. Potential intervention designs were presented to participants, and feedback on the designs was solicited. In Phase II, we conducted two pilot RCTs to determine the feasibility, acceptability, and preliminary efficacy of BPMED in primary care and emergency department settings. Both pilot studies recruited approximately 60 participants, who were randomized equally between usual care and the BPMED intervention. Results Although data collection is now complete, data analysis from the

  8. Telerehabilitation to improve outcomes for people with stroke: study protocol for a randomised controlled trial

    PubMed Central

    2012-01-01

    Background In New Zealand, around 45,000 people live with stroke and many studies have reported that benefits gained during initial rehabilitation are not sustained. Evidence indicates that participation in physical interventions can prevent the functional decline that frequently occurs after discharge from acute care facilities. However, on-going stroke services provision following discharge from acute care is often related to non-medical factors such as availability of resources and geographical location. Currently most people receive no treatment beyond three months post stroke. The study aims to determine if the Augmented Community Telerehabilitation Intervention (ACTIV) results in better physical function for people with stroke than usual care, as measured by the Stroke Impact Scale, physical subcomponent. Methods/design This study will use a multi-site, two-arm, assessor blinded, parallel randomised controlled trial design. People will be eligible if they have had their first ever stroke, are over 20 and have some physical impairment in either arm or leg, or both. Following discharge from formal physiotherapy services (inpatient, outpatient or community), participants will be randomised into ACTIV or usual care. ACTIV uses readily available technology, telephone and mobile phones, combined with face-to-face visits from a physiotherapist over a six-month period, to help people with stroke resume activities they enjoyed before the stroke. The impact of stroke on physical function and quality of life will be assessed, measures of cost will be collected and a discrete choice survey will be used to measure preferences for rehabilitation options. These outcomes will be collected at baseline, six months and 12 months. In-depth interviews will be used to explore the experiences of people participating in the intervention arm of the study. Discussion The lack of on-going rehabilitation for people with stroke diminishes the chance of their best possible outcome and may

  9. A randomised controlled trial of benefit finding in caregivers: The Building Resources in Caregivers Study Protocol.

    PubMed

    Brand, Charles; O'Connell, Brenda H; Gallagher, Stephen

    2015-07-01

    Caregivers may engage in benefit finding, that is, an increase in perceived positive growth, as a cognitive strategy for coping with stress. The Building Resources in Caregivers study will compare effects of a brief benefit finding writing intervention with a control intervention. Caregivers of people with mental and physical disabilities will be randomised into either a benefit-writing group or a neutral writing group. Caregivers will complete measures relating to themselves and care-recipients (e.g. sociodemographics and illness type) and psychometric measures of benefit finding, distress and quality of life at three time points. Additionally, qualitative commentary on participation experiences will be gathered.

  10. Testing a Dutch web-based tailored lifestyle programme among adults: a study protocol

    PubMed Central

    2011-01-01

    Background Smoking, high alcohol consumption, unhealthy eating habits and physical inactivity often lead to (chronic) diseases, such as cardiovascular diseases and cancer. Tailored online interventions have been proven to be effective in changing health behaviours. The aim of this study is to test and compare the effectiveness of two different tailoring strategies for changing lifestyle compared to a control group using a multiple health behaviour web-based approach. Methods In our Internet-based tailored programme, the five lifestyle behaviours of smoking, alcohol intake, fruit consumption, vegetable consumption, and physical activity are addressed. This randomized controlled trial, conducted among Dutch adults, includes two experimental groups (i.e., a sequential behaviour tailoring condition and a simultaneous behaviour tailoring condition) and a control group. People in the sequential behaviour tailoring condition obtain feedback on whether their lifestyle behaviours meet the Dutch recommendations. Using a step-by-step approach, they are stimulated to continue with a computer tailored module to change only one unhealthy behaviour first. In the course of the study, they can proceed to change a second behaviour. People in the simultaneous behaviour tailoring condition receive computer tailored feedback about all their unhealthy behaviours during their first visit as a stimulation to change all unhealthy behaviours. The experimental groups can re-visit the website and can then receive ipsative feedback (i.e., current scores are compared to previous scores in order to give feedback about potential changes). The (difference in) effectiveness of the different versions of the programme will be tested and compared to a control group, in which respondents only receive a short health risk appraisal. Programme evaluations will assess satisfaction with and appreciation and personal relevance of the intervention among the respondents. Finally, potential subgroup differences

  11. Study Protocol: Screening and Treatment of Alcohol-Related Trauma (START) – a randomised controlled trial

    PubMed Central

    2012-01-01

    Background The incidence of mandibular fractures in the Northern Territory of Australia is very high, especially among Indigenous people. Alcohol intoxication is implicated in the majority of facial injuries, and substance use is therefore an important target for secondary prevention. The current study tests the efficacy of a brief therapy, Motivational Care Planning, in improving wellbeing and substance misuse in youth and adults hospitalised with alcohol-related facial trauma. Methods and design The study is a randomised controlled trial with 6 months of follow-up, to examine the effectiveness of a brief and culturally adapted intervention in improving outcomes for trauma patients with at-risk drinking admitted to the Royal Darwin Hospital maxillofacial surgery unit. Potential participants are identified using AUDIT-C questionnaire. Eligible participants are randomised to either Motivational Care Planning (MCP) or Treatment as Usual (TAU). The outcome measures will include quantity and frequency of alcohol and other substance use by Timeline Followback. The recruitment target is 154 participants, which with 20% dropout, is hoped to provide 124 people receiving treatment and follow-up. Discussion This project introduces screening and brief interventions for high-risk drinkers admitted to the hospital with facial trauma. It introduces a practical approach to integrating brief interventions in the hospital setting, and has potential to demonstrate significant benefits for at-risk drinkers with facial trauma. Trial Registration The trial has been registered in Australian New Zealand Clinical Trials Registry (ANZCTR) and Trial Registration: ACTRN12611000135910. PMID:23106916

  12. Study Protocol on Intentional Distortion in Personality Assessment: Relationship with Test Format, Culture, and Cognitive Ability

    PubMed Central

    Van Geert, Eline; Orhon, Altan; Cioca, Iulia A.; Mamede, Rui; Golušin, Slobodan; Hubená, Barbora; Morillo, Daniel

    2016-01-01

    Self-report personality questionnaires, traditionally offered in a graded-scale format, are widely used in high-stakes contexts such as job selection. However, job applicants may intentionally distort their answers when filling in these questionnaires, undermining the validity of the test results. Forced-choice questionnaires are allegedly more resistant to intentional distortion compared to graded-scale questionnaires, but they generate ipsative data. Ipsativity violates the assumptions of classical test theory, distorting the reliability and construct validity of the scales, and producing interdependencies among the scores. This limitation is overcome in the current study by using the recently developed Thurstonian item response theory model. As online testing in job selection contexts is increasing, the focus will be on the impact of intentional distortion on personality questionnaire data collected online. The present study intends to examine the effect of three different variables on intentional distortion: (a) test format (graded-scale versus forced-choice); (b) culture, as data will be collected in three countries differing in their attitudes toward intentional distortion (the United Kingdom, Serbia, and Turkey); and (c) cognitive ability, as a possible predictor of the ability to choose the more desirable responses. Furthermore, we aim to integrate the findings using a comprehensive model of intentional distortion. In the Anticipated Results section, three main aspects are considered: (a) the limitations of the manipulation, theoretical approach, and analyses employed; (b) practical implications for job selection and for personality assessment in a broader sense; and (c) suggestions for further research. PMID:27445902

  13. Study Protocol on Intentional Distortion in Personality Assessment: Relationship with Test Format, Culture, and Cognitive Ability.

    PubMed

    Van Geert, Eline; Orhon, Altan; Cioca, Iulia A; Mamede, Rui; Golušin, Slobodan; Hubená, Barbora; Morillo, Daniel

    2016-01-01

    Self-report personality questionnaires, traditionally offered in a graded-scale format, are widely used in high-stakes contexts such as job selection. However, job applicants may intentionally distort their answers when filling in these questionnaires, undermining the validity of the test results. Forced-choice questionnaires are allegedly more resistant to intentional distortion compared to graded-scale questionnaires, but they generate ipsative data. Ipsativity violates the assumptions of classical test theory, distorting the reliability and construct validity of the scales, and producing interdependencies among the scores. This limitation is overcome in the current study by using the recently developed Thurstonian item response theory model. As online testing in job selection contexts is increasing, the focus will be on the impact of intentional distortion on personality questionnaire data collected online. The present study intends to examine the effect of three different variables on intentional distortion: (a) test format (graded-scale versus forced-choice); (b) culture, as data will be collected in three countries differing in their attitudes toward intentional distortion (the United Kingdom, Serbia, and Turkey); and (c) cognitive ability, as a possible predictor of the ability to choose the more desirable responses. Furthermore, we aim to integrate the findings using a comprehensive model of intentional distortion. In the Anticipated Results section, three main aspects are considered: (a) the limitations of the manipulation, theoretical approach, and analyses employed; (b) practical implications for job selection and for personality assessment in a broader sense; and

  14. Root canal obturation: experimental study on the thermafil system related to different irrigation protocols

    PubMed Central

    Migliau, Guido; Sofan, Afrah Ali Abdullah; Sofan, Eshrak Ali Abdullah; Cosma, Salvatore; Eramo, Stefano; Gallottini, Livio

    2014-01-01

    Summary Aim The aim of this study was to stress the ability of a specific obturation technique (thermafil technique) to seal root canal system in presence or absence of smear layer. Methodology Sixteen monoradicular teeth, extracted for periodontal reasons, were collected for this study. All specimens were prepared with nickel-titanium rotary files, and then divided into two groups: for each group was applied a different kind of irrigation method, verifying the effectiveness in removing the smear layer, thus rendering the dentinal tubules more permeable for penetration of softened gutta-percha. Thermafil system was used to fill the root canals, and then all the specimens were observed under scanning electron microscope (SEM). Results The results showed that the Group which followed irrigation only with sodium hypochlorite exhibited significantly less gutta-percha tags when compared to the second Group, which was irrigated with sodium hypochlorite and EDTA. Conclusion The thermafil systems have a very good quality of compression and fluency that permit to gain a good seal of endodontic space; furthermore it allows the penetration of gutta-percha with the formation of numerous of gutta-percha tags inside the dentinal tubules above all when smear layer is reduced or eliminated. PMID:25506413

  15. Culturally-Tailored Smoking Cessation for American Indians: Study protocol for a randomized controlled trial

    PubMed Central

    2011-01-01

    Background Cigarette smoking is the number one cause of preventable death among American Indian and Alaska Natives, AI/ANs. Two out of every five AI/AN will die from tobacco-related diseases if the current smoking rates of AI/ANs (40.8%) persist. Currently, there is no proven, effective culturally-tailored smoking cessation program designed specifically for a heterogeneous population of AI. The primary aim of this group randomized clinical trial is to test the efficacy of "All Nations Breath of Life" (ANBL) program compared to a non-tailored "Current Best Practices" smoking cessation program among AI smokers. Methods We will randomize 56 groups (8 smokers per group) to the tailored program or non-tailored program for a total sample size of 448 American Indian smokers. All participants in the proposed study will be offered pharmacotherapy, regardless of group assignment. This study is the first controlled trial to examine the efficacy of a culturally-tailored smoking cessation program for American Indians. If the intervention is successful, the potential health impact is significant because the prevalence of smoking is the highest in this population. Trial Registration ClinicalTrials.gov: NCT01106456 PMID:21592347

  16. A comparative study of Sterofundin and Ringer lactate based infusion protocol in scoliosis correction surgery

    PubMed Central

    Sharma, Ashima; Yadav, Monu; Kumar, B. Rajesh; Lakshman, P. Sai; Iyenger, Raju; Ramchandran, Gopinath

    2016-01-01

    Background: A major change in anesthesia practice as regards to intraoperative infusion therapy is the present requirement. Switching over to balanced fluids can substantially decrease the incidence of lactic acidosis and hyperchloremic acidosis. The deleterious effects of unbalanced fluids are more recognizable during major surgeries. We prospectively studied the influence of Sterofundin (SF) and Ringer lactate (RL) on acid–base changes, hemodynamics, and readiness for extubation during scoliosis surgery. Subjects and Methods: Thirty consecutive children posted for scoliosis surgery were randomized to receive either RL (n = 15) or SF (n = 15) as intraoperative fluid at 10 mg/kg/h. Fluid boluses were added according to the study fluid algorithm. Arterial blood was sampled and analyzed at hourly intervals during surgery. Red blood cell transfusion was guided by hematocrit below 27. Patients were followed for 24 h postoperatively in the Intensive Care Unit. Results: There was no statistically significant difference in the volume of infused fluid (2400 ± 512 ml in Group RL and 2200 ± 640 ml in Group SF. There were no significant changes in pH of patients infused with SF. Statistically, significant higher lactate levels were seen in RL-infused group. The strong ion difference was decreased in both groups, but it normalized earlier with SF. Conclusions: SF-infused patients had nonremarkable changes in acid–base physiology in scoliosis surgery. PMID:27746547

  17. Social networks of health care providers and patients in cardiovascular risk management: a study protocol

    PubMed Central

    2014-01-01

    Background In recent years, preventive and clinical interventions for cardiovascular risk management have been implemented widely in primary care in the Netherlands. Although this has enhanced quality and outcomes of cardiovascular risk management, further improvement remains possible. In the planned observational study, we aim to examine the role of social networks of healthcare providers and patients in quality and outcomes of cardiovascular risk management. Methods/Design In a longitudinal observational study, data on social networks of approximately 300 primary care providers from 30 general practices and 900 cardiovascular patients will be collected twice, with a six month interval, using a mix of measures. Social networks are documented with specifically designed questionnaires for patients, relatives, and healthcare professionals. For each included patient, we will extract from medical records to gather data on clinical processes and cardiovascular risk predictors. Data on self-management and psychosocial outcomes of patients will be collected using questionnaires for patients. The analysis focuses on identifying network characteristics, which are associated with (changes in) cardiovascular risk management or self-management. Discussion This research will provide insight into the role of social networks of patients and providers in cardiovascular risk management in primary practice. Trial registration Nederlands Trial Register NTR4069. PMID:24942555

  18. Low-Frequency Repetitive Transcranial Magnetic Stimulation and Intensive Occupational Therapy for Poststroke Patients with Upper Limb Hemiparesis: Preliminary Study of a 15-Day Protocol

    ERIC Educational Resources Information Center

    Kakuda, Wataru; Abo, Masahiro; Kobayashi, Kazushige; Momosaki, Ryo; Yokoi, Aki; Fukuda, Akiko; Ishikawa, Atsushi; Ito, Hiroshi; Tominaga, Ayumi

    2010-01-01

    The purpose of the study was to determine the safety and feasibility of a 15-day protocol of low-frequency repetitive transcranial magnetic stimulation (rTMS) combined with intensive occupational therapy (OT) on motor function and spasticity in hemiparetic upper limbs in poststroke patients. Fifteen poststroke patients (age at study entry 55 [plus…

  19. Prevalence of symptoms of severe asthma and allergies in Irish school children: an ISAAC protocol study, 1995-2007.

    PubMed

    Kabir, Zubair; Manning, Patrick J; Holohan, Jean; Goodman, Patrick G; Clancy, Luke

    2011-08-01

    Childhood asthma is a recurring health burden and symptoms of severe asthma in children are also emerging as a health and economic issue. This study examined changing patterns in symptoms of severe asthma and allergies (ever eczema and hay fever), using the Irish International Study of Asthma and Allergies in Childhood (ISAAC) protocol. ISAAC is a cross-sectional self-administered questionnaire survey of randomly selected representative post-primary schools. Children aged 13-14 years were studied: 2,670 (in 1995), 2,273 (in 1998), 2,892 (in 2002-2003), and 2,805 (in 2007). Generalized linear modelling using Poisson distribution was employed to compute adjusted prevalence ratios (PR). A 39% significant increase in symptoms of severe asthma was estimated in 2007 relative to the baseline year 1995 (adjusted PR: 1.39 [95% CI: 1.14-1.69]) increasing from 12% in 1995 to 15.3% in 2007. Opposite trends were observed for allergies, showing a decline in 2007, with an initial rise. The potential explanations for such a complex disease pattern whose aetiological hypothesis is still evolving are speculative. Changing environmental factors may be a factor, for instance, an improvement in both outdoor and indoor air quality further reinforcing the hygiene hypothesis but obesity as a disease modifier must also be considered.

  20. Formative research to develop theory-based messages for a Western Australian child drowning prevention television campaign: study protocol

    PubMed Central

    Denehy, Mel; Crawford, Gemma; Leavy, Justine; Nimmo, Lauren; Jancey, Jonine

    2016-01-01

    Introduction Worldwide, children under the age of 5 years are at particular risk of drowning. Responding to this need requires the development of evidence-informed drowning prevention strategies. Historically, drowning prevention strategies have included denying access, learning survival skills and providing supervision, as well as education and information which includes the use of mass media. Interventions underpinned by behavioural theory and formative evaluation tend to be more effective, yet few practical examples exist in the drowning and/or injury prevention literature. The Health Belief Model and Social Cognitive Theory will be used to explore participants' perspectives regarding proposed mass media messaging. This paper describes a qualitative protocol to undertake formative research to develop theory-based messages for a child drowning prevention campaign. Methods and analysis The primary data source will be focus group interviews with parents and caregivers of children under 5 years of age in metropolitan and regional Western Australia. Qualitative content analysis will be used to analyse the data. Ethics and dissemination This study will contribute to the drowning prevention literature to inform the development of future child drowning prevention mass media campaigns. Findings from the study will be disseminated to practitioners, policymakers and researchers via international conferences, peer and non-peer-reviewed journals and evidence summaries. The study was submitted and approved by the Curtin University Human Research Ethics Committee. PMID:27207621

  1. Does telecare prolong community living in dementia? A study protocol for a pragmatic, randomised controlled trial

    PubMed Central

    2013-01-01

    Background Assistive technology and telecare (ATT) are relatively new ways of delivering care and support to people with social care needs. It is claimed that ATT reduces the need for community care, prevents unnecessary hospital admission, and delays or prevents admission into residential or nursing care. The current economic situation in England has renewed interest in ATT instead of community care packages. However, at present, the evidence base to support claims about the impact and effectiveness of ATT is limited, despite its potential to mitigate the high financial cost of caring for people with dementia and the social and psychological cost to unpaid carers. Method/design ATTILA (Assistive Technology and Telecare to maintain Independent Living At Home for People with Dementia) is a pragmatic, multi-centre, randomised controlled trial over 104 weeks that compares outcomes for people with dementia who receive ATT and those who receive equivalent community services but not ATT. The study hypothesis is that fewer people in the ATT group will go into institutional care over the 4-year period for which the study is funded. The study aims to recruit 500 participants, living in community settings, with dementia or significant cognitive impairment, who have recently been referred to social services. Primary outcome measures are time in days from randomisation to institutionalisation and cost effectiveness. Secondary outcomes are caregiver burden, health-related quality of life in carers, number and severity of serious adverse events, and data on acceptability, applicability and reliability of ATT intervention packages. Assessments will be undertaken in weeks 0 (baseline), 12, 24, 52 and 104 or until institutionalisation or withdrawal of the participant from the trial. Discussion In a time of financial austerity, CASSRs in England are increasingly turning to ATT in the belief that it will deliver good outcomes for less money. There is an absence of robust evidence for

  2. The Diabetes Care Project: an Australian multicentre, cluster randomised controlled trial [study protocol

    PubMed Central

    2013-01-01

    Background Diabetes mellitus is an increasingly prevalent metabolic disorder that is associated with substantial disease burden. Australia has an opportunity to improve ways of caring for the growing number of people with diabetes, but this may require changes to the way care is funded, organised and delivered. To inform how best to care for people with diabetes, and to identify the extent of change that is required to achieve this, the Diabetes Care Project (DCP) will evaluate the impact of two different, evidence-based models of care (compared to usual care) on clinical quality, patient and provider experience, and cost. Methods/Design The DCP uses a pragmatic, cluster randomised controlled trial design. Accredited general practices that are situated within any of the seven Australian Medicare Locals/Divisions of General Practice that have agreed to take part in the study were invited to participate. Consenting practices will be randomly assigned to one of three treatment groups for approximately 18 to 22 months: (a) control group (usual care); (b) Intervention 1 (which tests improvements that could be made within the current funding model, facilitated through the use of an online chronic disease management network); or (c) Intervention 2 (which includes the same components as Intervention 1, as well as altered funding to support voluntary patient registration with their practice, incentive payments and a care facilitator). Adult patients who attend the enrolled practices and have established (≥12 month’s duration) type 1 diabetes mellitus or newly diagnosed or established type 2 diabetes mellitus are invited to participate. Multiple outcomes will be studied, including changes in glycosylated haemoglobin (primary outcome), changes in other biochemical and clinical metrics, incidence of diabetes-related complications, quality of life, clinical depression, success of tailored care, patient and practitioner satisfaction, and budget sustainability. Discussion

  3. Acupuncture for menopausal vasomotor symptoms: study protocol for a randomised controlled trial

    PubMed Central

    2014-01-01

    Background Hot flushes and night sweats (vasomotor symptoms) are common menopausal symptoms, often causing distress, sleep deprivation and reduced quality of life. Although hormone replacement therapy is an effective treatment, there are concerns about serious adverse events. Non-hormonal pharmacological therapies are less effective and can also cause adverse effects. Complementary therapies, including acupuncture, are commonly used for menopausal vasomotor symptoms. While the evidence for the effectiveness of acupuncture in treating vasomotor symptoms is inconclusive, acupuncture has a low risk of adverse effects, and two small studies suggest it may be more effective than non-insertive sham acupuncture. Our objective is to assess the efficacy of needle acupuncture in improving hot flush severity and frequency in menopausal women. Our current study design is informed by methods tested in a pilot study. Methods/design This is a stratified, parallel, randomised sham-controlled trial with equal allocation of participants to two trial groups. We are recruiting 360 menopausal women experiencing a minimum average of seven moderate hot flushes a day over a seven-day period and who meet diagnostic criteria for the Traditional Chinese Medicine diagnosis of Kidney Yin deficiency. Exclusion criteria include breast cancer, surgical menopause, and current hormone replacement therapy use. Eligible women are randomised to receive either true needle acupuncture or sham acupuncture with non-insertive (blunt) needles for ten treatments over eight weeks. Participants are blinded to treatment allocation. Interventions are provided by Chinese medicine acupuncturists who have received specific training on trial procedures. The primary outcome measure is hot flush score, assessed using the validated Hot Flush Diary. Secondary outcome measures include health-related quality of life, anxiety and depression symptoms, credibility of the sham treatment, expectancy and beliefs about

  4. Prophylactic antibiotic regimens in tumour surgery (PARITY): protocol for a multicentre randomised controlled study

    PubMed Central

    Ghert, Michelle; Deheshi, Benjamin; Holt, Ginger; Randall, R Lor; Ferguson, Peter; Wunder, Jay; Turcotte, Robert; Werier, Joel; Clarkson, Paul; Damron, Timothy; Benevenia, Joseph; Anderson, Megan; Gebhardt, Mark; Isler, Marc; Mottard, Sophie; Healey, John; Evaniew, Nathan; Racano, Antonella; Sprague, Sheila; Swinton, Marilyn; Bryant, Dianne; Thabane, Lehana; Guyatt, Gordon; Bhandari, Mohit

    2012-01-01

    Introduction Limb salvage with endoprosthetic reconstruction is the standard of care for the management of lower-extremity bone tumours in skeletally mature patients. The risk of deep postoperative infection in these procedures is high and the outcomes can be devastating. The most effective prophylactic antibiotic regimen remains unknown, and current clinical practice is highly varied. This trial will evaluate the effect of varying postoperative prophylactic antibiotic regimens on the incidence of deep infection following surgical excision and endoprosthetic reconstruction of lower-extremity bone tumours. Methods and analysis This is a multicentre, blinded, randomised controlled trial, using a parallel two-arm design. 920 patients 15 years of age or older from 12 tertiary care centres across Canada and the USA who are undergoing surgical excision and endoprosthetic reconstruction of a primary bone tumour will receive either short (24 h) or long (5 days) duration postoperative antibiotics. Exclusion criteria include prior surgery or infection within the planned operative field, known colonisation with methicillin-resistant Staphylococcus aureus or vancomycin-resistant Enterococcus at enrolment, or allergy to the study antibiotics. The primary outcome will be rates of deep postoperative infections in each arm. Secondary outcomes will include type and frequency of antibiotic-related adverse events, patient functional outcomes and quality-of-life scores, reoperation and mortality. Randomisation will be blocked, with block sizes known only to the methods centre responsible for randomisation, and stratified by location of tumour and study centre. Patients, care givers and a Central Adjudication Committee will be blinded to treatment allocation. The analysis to compare groups will be performed using Cox regression and log-rank tests to compare survival functions at α=0.05. Ethics and dissemination This study has ethics approval from the McMaster University

  5. Food choices and practices during pregnancy of immigrant and Aboriginal women in Canada: a study protocol

    PubMed Central

    2011-01-01

    Background Facilitating the provision of appropriate health care for immigrant and Aboriginal populations in Canada is critical for maximizing health potential and well-being. Numerous reports describe heightened risks of poor maternal and birth outcomes for immigrant and Aboriginal women. Many of these outcomes may relate to food consumption/practices and thus may be obviated through provision of resources which suit the women's ethnocultural preferences. This project aims to understand ethnocultural food and health practices of Aboriginal and immigrant women, and how these intersect with respect to the legacy of Aboriginal colonialism and to the social contexts of cultural adaptation and adjustment of immigrants. The findings will inform the development of visual tools for health promotion by practitioners. Methods/Design This four-phase study employs a case study design allowing for multiple means of data collection and different units of analysis. Phase 1 consists of a scoping review of the literature. Phases 2 and 3 incorporate pictorial representations of food choices (photovoice in Phase 2) with semi-structured photo-elicited interviews (in Phase 3). The findings from Phases 1-3 and consultations with key stakeholders will generate key understandings for Phase 4, the production of culturally appropriate visual tools. For the scoping review, an emerging methodological framework will be utilized in addition to systematic review guidelines. A research librarian will assist with the search strategy and retrieval of literature. For Phases 2 and 3, recruitment of 20-24 women will be facilitated by team member affiliations at perinatal clinics in one of the city's most diverse neighbourhoods. The interviews will reveal culturally normative practices surrounding maternal food choices and consumption, including how women negotiate these practices within their own worldview and experiences. A structured and comprehensive integrated knowledge translation plan has been

  6. Intervention to improve social and family support for caregivers of dependent patients: ICIAS study protocol

    PubMed Central

    2014-01-01

    Background Despite the existence of formal professional support services, informal support (mainly family members) continues to be the main source of eldercare, especially for those who are dependent or disabled. Professionals on the primary health care are the ideal choice to educate, provide psychological support, and help to mobilize social resources available to the informal caregiver. Controversy remains concerning the efficiency of multiple interventions, taking a holistic approach to both the patient and caregiver, and optimum utilization of the available community resources. .For this reason our goal is to assess whether an intervention designed to improve the social support for caregivers effectively decreases caregivers burden and improves their quality of life. Methods/design Design: Controlled, multicentre, community intervention trial, with patients and their caregivers randomized to the intervention or control group according to their assigned Primary Health Care Team (PHCT). Study area: Primary Health Care network (9 PHCTs). Study participants: Primary informal caregivers of patients receiving home health care from participating PHCTs. Sample: Required sample size is 282 caregivers (141 from PHCTs randomized to the intervention group and 141 from PHCTs randomized to the control group. Intervention: a) PHCT professionals: standardized training to implement caregivers intervention. b) Caregivers: 1 individualized counselling session, 1 family session, and 4 educational group sessions conducted by participating PHCT professionals; in addition to usual home health care visits, periodic telephone follow-up contact and unlimited telephone support. Control: Caregivers and dependent patients: usual home health care, consisting of bimonthly scheduled visits, follow-up as needed, and additional attention upon request. Data analysis Dependent variables: Caregiver burden (short-form Zarit test), caregivers’ social support (Medical Outcomes Study), and

  7. 40 CFR 792.120 - Protocol.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... dated signature of the study director. (15) A statement of the proposed statistical method. (b) All...) GOOD LABORATORY PRACTICE STANDARDS Protocol for and Conduct of A Study § 792.120 Protocol. (a) Each study shall have an approved written protocol that clearly indicates the objectives and all methods...

  8. 40 CFR 792.120 - Protocol.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... dated signature of the study director. (15) A statement of the proposed statistical method. (b) All...) GOOD LABORATORY PRACTICE STANDARDS Protocol for and Conduct of A Study § 792.120 Protocol. (a) Each study shall have an approved written protocol that clearly indicates the objectives and all methods...

  9. Radiation Behavior of Analog Neural Network Chip

    NASA Technical Reports Server (NTRS)

    Langenbacher, H.; Zee, F.; Daud, T.; Thakoor, A.

    1996-01-01

    A neural network experiment conducted for the Space Technology Research Vehicle (STRV-1) 1-b launched in June 1994. Identical sets of analog feed-forward neural network chips was used to study and compare the effects of space and ground radiation on the chips. Three failure mechanisms are noted.

  10. Nutritional Strategies Facing an Older Demographic: The Nutrition UP 65 Study Protocol

    PubMed Central

    2016-01-01

    Background The population of Portugal is aging. The lack of data on older adults’ nutritional status and the lack of nutrition knowledge amongst health professionals, caregivers, and older adults themselves, remains a challenge. Objective The Nutrition UP 65 study aims to reduce nutritional inequalities in the older Portuguese adult population and improve knowledge regarding older Portuguese adults’ nutritional status, specifically relating to undernutrition, obesity, sarcopenia, frailty, hydration, sodium, and vitamin D statuses. Methods A representative sample of older Portuguese adults was selected. Sociodemographic, lifestyle, anthropometric, functional, and clinical data were collected. Sodium excretion, hydration, and vitamin D statuses were assessed. Results Data collection (n=1500) took place between December, 2015 and June, 2016. Results will be disseminated in national and international scientific journals, and via Portuguese media. Conclusions Nutrition UP 65 results will provide evidence for the design and implementation of effective preventive public health strategies regarding the elderly. These insights may represent relevant health gains and costs savings. PMID:27628097

  11. Terminology, Taxonomy, and Facilitation of Motor Learning in Clinical Practice: Protocol of a Delphi Study

    PubMed Central

    Bleijlevens, Michel HC; Beurskens, Anna JHM; Rasquin, Sascha M; Halfens, Jos; Wilson, Mark R; Masters, Rich S; Lexis, Monique A; Braun, Susy M

    2013-01-01

    Background Facilitating motor learning in patients during clinical practice is complex, especially in people with cognitive impairments. General principles of motor learning are available for therapists to use in their practice. However, the translation of evidence from the different fields of motor learning for use in clinical practice is problematic due to lack of uniformity in definition and taxonomy of terms related to motor learning. Objective The objective of this paper was to describe the design of a Delphi technique to reach consensus on definitions, descriptions, and taxonomy used within motor learning and to explore experts’ opinions and experiences on the application of motor learning in practice. Methods A heterogeneous sample of at least 30 international experts on motor learning will be recruited. Their opinions regarding several central topics on motor learning using a Delphi technique will be collected in 3 sequential rounds. The questionnaires in the 3 rounds will be developed based on the literature and answers of experts from earlier rounds. Consensus will be reached when at least 70% of the experts agree on a certain topic. Free text comments and answers from open questions on opinions and experiences will be described and clustered into themes. Results This study is currently ongoing. It is financially supported by Stichting Alliantie Innovatie (Innovation Alliance Foundation), RAAK-international (Registration number: 2011-3-33int). Conclusions The results of this study will enable us to summarize and categorize expert knowledge and experiences in a format that should be more accessible for therapists to use in support of their clinical practice. Unresolved aspects will direct future research. PMID:23685621

  12. A prospective cohort study to evaluate peridomestic infection as a determinant of dengue transmission: Protocol

    PubMed Central

    2012-01-01

    Background Vector control programs, which have focused mainly on the patient house and peridomestic areas around dengue cases, have not produced the expected impact on transmission. This project will evaluate the assumption that the endemic/epidemic transmission of dengue begins around peridomestic vicinities of the primary cases. Its objective is to assess the relationship between symptomatic dengue case exposure and peridomestic infection incidence. Methods/Design A prospective cohort study will be conducted (in Tepalcingo and Axochiapan, in the state of Morelos, Mexico), using the state surveillance system for the detection of incident cases. Paired blood specimens will be collected from both the individuals who live with the incident cases and a sample of subjects residing within a 25-meter radius of such cases (exposed cohort), in order to measure dengue-specific antibodies. Other subjects will be selected from areas which have not presented any incident cases within 200 meters, during the two months preceding the sampling (non-exposed cohort). Symptomatic/asymptomatic incident infection will be considered as the dependent variable, exposure to confirmed dengue cases, as the principal variable, and the socio-demographic, environmental and socio-cultural conditions of the subjects, as additional explanatory variables. Discussion Results indicating a high infection rate among the exposed subjects would justify the application of peridomestic control measures and call for an evaluation of alternate causes for insufficient program impact. On the other hand, a low incidence of peridomestic-infected subjects would support the hypothesis that infection occurs outside the domicile, and would thus explain why the vector control measures applied in the past have exerted such a limited impact on cases incidence rates. The results of the present study may therefore serve to reassess site selection for interventions of this type. PMID:22471857

  13. Classic yin and yang tonic formula for osteopenia: study protocol for a randomized controlled trial

    PubMed Central

    2011-01-01

    Background Osteoporosis is a growing worldwide problem, with the greatest burden resulting from fractures. Nevertheless, the majority of fractures in adults occur in those with "osteopenia" (bone mineral density (BMD) only moderately lower than young normal individuals). Since long-term drug therapy is an expensive option with uncertain consequences and side effects, natural herbal therapy offers an attractive alternative. The purpose of this study is to evaluate the effect on BMD and safety of the Classic Yin and Yang Tonic Formula for treatment of osteopenia and to investigate the mechanism by which this efficacy is achieved. Methods/design We propose a multicenter double-blind randomized placebo-controlled trial to evaluate the efficacy and safety of the Classic Yin and Yang Tonic Formula for the treatment of osteopenia. Participants aged 55 to 75 with low bone mineral density (T-score between -1 and -2.5) and kidney deficiency in TCM will be included and randomly allocated into two groups: treatment group and control group. Participants in the treatment group will be treated with Classic Yin and Yang Tonic Granule, while the controlled group will receive placebo. Primary outcome measure will be BMD of the lumbar spine and proximal femur using dual-energy X-ray absorptiometry. Secondary outcomes will include pain intensity measured with visual analogue scales, quality of life, serum markers of bone metabolism, indices of Neuro-endocrino-immune network and safety. Discussion If the Classic Yin and Yang Tonic Formula can increase bone mass without adverse effects, it may be a novel strategy for the treatment of osteoporosis. Furthermore, the mechanism of the Chinese medical formula for osteoporosis will be partially elucidated. Trial registration This study is registered at ClinicalTrials.gov, NCT01271647. PMID:21806837

  14. Same-Day Counseling: Study Protocol for the Evaluation of a New Mental Health Service

    PubMed Central

    Ewen, Victoria; Bailey, Kathleen; Haggarty, John M; Dama, Sumeet; Mushquash, Christopher J

    2016-01-01

    Background Single-session counseling is being implemented across Canada to increase the accessibility and availability of mental health services. Despite increasing use, existing research on single-session counseling is sparse and has methodological limitations. In addition, some stakeholders are skeptical that this model of care can support meaningful change for clients. Objective The aim of this study is to evaluate a new single-session counseling program (called Same-Day Counseling) offered in an outpatient community mental health clinic in Northwestern Ontario, Canada. Methods Clients who attend Same-Day Counseling services will be given the opportunity to participate in the program evaluation. Those who consent will complete measures before their session, after their session, and at 1-month follow-up. Data will provide information on who accesses Same-Day Counseling (eg, typical presenting problems, symptom severity), client satisfaction with services, and whether clients benefit from the services (eg, improved functioning and reduced symptom severity). Results Data collection is underway with 80 participants having completed baseline measures and 55 participants having completed follow-up measures. Data collection is expected to conclude in December 2015. Conclusions This study is designed to contribute to the literature regarding the integration of single-session counseling into ongoing mental health services, with additional attention to methodological rigour. Our approach will help to address ongoing concerns regarding the implementation of single-session counseling, and inform health care providers and policy makers regarding the utility of this model for addressing the mental health care need of the community. PMID:26842891

  15. A protocol-analytic study of metacognition in mathematical problem solving

    NASA Astrophysics Data System (ADS)

    Cai, Jinfa

    1994-12-01

    The metacognitive behaviours of two subjects having a high level of mathematical experience and two subjects having a low level of mathematical experience were compared within each of the four cognitive processes of mathematical problem solving: orientation, organisation, execution, and verification. The results showed that the high-experience subjects engaged in self-regulation during the problem-solving process and that the low-experience subjects did not. Also, the high-experience subjects had stronger awareness about what they knew and how they should use this knowledge, and were able to sequentially monitor their goal-changing and decision-making activities in order to implement their goal. Another important finding was that the high-experience subjects spent the majority of their time on orientation and organisation rather than on execution, while low-experience subjects spent the majority of their time on execution rather than on orientation and organisation. Finally, the high-experience subjects accurately evaluated their strategies, actions and intermediate results. The results suggest that individual differences between the high- and low-experience subjects are unlikely to emerge either from the subjects' selection of solution strategies or from the level of mathematical knowledge required for solving the problem. Therefore, the results from this study support the argument that metacognitive behaviours have important influences on subjects' problem-solving success. This study also suggests that a complex, difficult, or novel task appears to function well as a task for examining metacognitive behaviours because such a task results in the subjects being unable to arrive at closure quickly.

  16. The ASTUTE Health study protocol: Deliberative stakeholder engagements to inform implementation approaches to healthcare disinvestment

    PubMed Central

    2012-01-01

    Background Governments and other payers are yet to determine optimal processes by which to review the safety, effectiveness, and cost-effectiveness of technologies and procedures that are in active use within health systems, and rescind funding (partially or fully) from those that display poor profiles against these parameters. To further progress a disinvestment agenda, a model is required to support payers in implementing disinvestment in a transparent manner that may withstand challenge from vested interests and concerned citizens. Combining approaches from health technology assessment and deliberative democratic theory, this project seeks to determine if and how wide stakeholder engagement can contribute to improved decision-making processes, wherein the views of both vested and non-vested stakeholders are seen to contribute to informing policy implementation within a disinvestment context. Methods/design Systematic reviews pertaining to illustrative case studies were developed and formed the evidence base for discussion. Review findings were presented at a series of deliberative, evidence-informed stakeholder engagements, including partisan (clinicians and consumers) and non-partisan (representative community members) stakeholders. Participants were actively facilitated towards identifying shared and dissenting perspectives regarding public funding policy for each of the case studies and developing their own funding models in response to the evidence presented. Policy advisors will subsequently be invited to evaluate disinvestment options based on the scientific and colloquial evidence presented to them, and to explore the value of this information to their decision-making processes with reference to disinvestment. Discussion Analysis of the varied outputs of the deliberative engagements will contribute to the methodological development around how to best integrate scientific and colloquial evidence for consideration by policy advisors. It may contribute to

  17. Community pharmacist intervention in depressed primary care patients (PRODEFAR study): randomized controlled trial protocol

    PubMed Central

    Rubio-Valera, Maria; Serrano-Blanco, Antoni; Travé, Pere; Peñarrubia-María, M Teresa; Ruiz, Mar; Puj