The Use of Cigarette Package Inserts to Supplement Pictorial Health Warnings: An Evaluation of the Canadian Policy.

PubMed

Thrasher, James F; Osman, Amira; Abad-Vivero, Erika N; Hammond, David; Bansal-Travers, Maansi; Cummings, K Michael; Hardin, James W; Moodie, Crawford

2015-07-01

Canada is the first country in the world to require cigarette manufacturers to enclose package inserts to supplement the exterior pictorial health warning label (HWL). In June 2012, Canada implemented new HWL package inserts that include cessation tips accompanied by a pictorial image. This study aims to assess the extent to which adult smokers report reading the newly mandated HWL inserts and to see whether reading them is associated with making a quit attempt. Data were analyzed from an online consumer panel of Canadian adult smokers, aged 18-64 years. Five waves of data were collected between September 2012 and January 2014, separated by 4-months intervals (n = 1,000 at each wave). Logistic generalized estimating equation (GEE) models were estimated to assess correlates of reading inserts and whether doing so is associated with making a quit attempt by the subsequent wave. At each wave, between 26% and 31% of the sample reported having read HWL package inserts at least once in the prior month. Smokers who read them were more likely to be younger, female, have higher income, intend to quit, have recently tried to quit, and thought more frequently about health risks because of warning labels. In models that adjusted for these and other potential confounders, smokers who read the inserts a few times or more in the past month were more likely to make a quit attempt at the subsequent wave compared to smokers who did not read the inserts. HWL package inserts with cessation-related tips and messages appear to increase quit attempts made by smokers. © The Author 2014. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Deficiencies of product labeling directions for the preparation of radiopharmaceuticals.

PubMed

Hung, Joseph C; Ponto, James A; Gadient, Katie R; Frie, Julia A; Aksamit, Carolyn M; Enquist, Cassandra L; Carrels, Katie E

2004-01-01

To identify potential deficiencies in product labeling (package insert) instructions for the preparation of radiopharmaceuticals. Preparation instructions, which include both reconstitution and quality control (QC) directions, as stated in the package inserts were evaluated for all commercially available reconstituted radiopharmaceuticals. Reviews of the package inserts were initially performed by each author, and then all identified deficiencies were compiled and evaluated by all authors. The preparation scenario for each package insert evaluated was based on a centralized nuclear pharmacy operation assuming typical support personnel, standard operating equipment, and workload. The instructions as stated in each package insert for the preparation (including QC) were rated as inadequate if a satisfactory preparation could not be prepared by a nuclear pharmacist or physician when instructions were followed exactly. Identified deficiencies in package insert instructions for the preparation of radiopharmaceuticals fell into the following five categories: (1) absent or incomplete directions (especially with regard to QC procedures); (2) restrictive directions (e.g., specific requirement to use designated needles, chromatography solvents, counting devices), (3) inconsistent directions (e.g., different reconstituted volumes for the same final drug product, unworkable expiration times); (4) impractical directions (e.g., unrealistically low reconstituted activity limits, dangerously high number of radiolabeled particles); and (5) vague directions (e.g., use of the words "should," "may," "recommend"). Manufacturers' directions for the preparation of radiopharmaceuticals often contain deficiencies and should be viewed as standard guidance rather than as requirements. Just as physicians are permitted to use U.S. Food and Drug Administration (FDA)-approved drugs for off-label indications, nuclear pharmacists should be allowed to use alternative methods for preparing radiopharmaceuticals, provided those methods have been validated to be as good as the stated directions and that the nuclear pharmacists do not engage in activities that fall outside the normal practice of pharmacy. Manufacturers, FDA, nuclear pharmacists, and nuclear physicians should work together to address identified deficiencies in package insert directions.

[A comparative analysis of inner wrapping and package inserts for medicines containing Panax ginseng C. A. Meyer].

PubMed

Auricchio, Mariangela Tirico; Batistic-Longatto, Mônica Arcon; Nicoletti, Maria Aparecida

2007-10-01

The information provided on package inserts and inner wrapping of eight products containing Panax ginseng from different manufacturers was compared internally and checked against data from the scientific literature. The inserts included extensive text, containing abundant information on indications for use, but no scientific evidence in humans. All the inserts lacked information on potential adverse effects and drug interaction. There was no standardization as to dose regimens, particularly in relation to the dried extract and ginsenoside concentration. The eight inserts thus showed no concern over standardization, indication for usage, or possible side effects and drug interactions.

Mental models in risk assessment: informing people about drugs.

PubMed

Jungermann, H; Schütz, H; Thüring, M

1988-03-01

One way to communicate about the risks of drugs is through the use of package inserts. The problems associated with this medium of informing patients have been investigated by several researchers who found that people require information about drugs they are using, including extensive risk information, and that they are willing to take this information into account in their usage of drugs. But empirical results also show that people easily misinterpret the information given. A conceptual framework is proposed that might be used for better understanding the cognitive processes involved in such a type of risk assessment and communication. It is based on the idea that people develop, through experience, a mental model of how a drug works, which effects it might produce, that contraindications have to be considered, etc. This mental model is "run" when a specific package insert has been read and a specific question arises such as, for example, whether certain symptoms can be explained as normal or whether they require special attention and action. We argue that the mental model approach offers a useful perspective for examining how people understand package inserts, and consequently for improving their content and design. The approach promises to be equally useful for other aspects of risk analysis that are dependent upon human judgment and decision making, e.g., threat diagnosis and human reliability analysis.

78 FR 63226 - GlaxoSmithKline LLC; Withdrawal of Approval of the Indication for Treatment of Patients With...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-23

... have not received prior rituximab, for BEXXAR (tositumomab and iodine I 131 tositumomab) Injection held... withdraw the rituximab-na[iuml]ve indication for BEXXAR (tositumomab and iodine I 131 tositumomab... indication for BEXXAR (tositumomab and iodine I 131 tositumomab) Injection from the package insert. In the...

48 CFR 552.211-75 - Preservation, Packaging and Packing.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 4 2010-10-01 2010-10-01 false Preservation, Packaging....211-75 Preservation, Packaging and Packing. As prescribed in 511.204(b)(2), insert the following clause: Preservation, Packaging, and Packing (FEB 1996) Unless otherwise specified, all items shall be...

Prospective clinical evaluation of the Polyperf® Safe, a safety Huber needle, in cancer patients.

PubMed

Goossens, Godelieve A; Moons, Philip; Jérôme, Martine; Stas, Marguerite

2011-01-01

Evaluation of the Polyperf® Safe (PPS) needle on safety and user-friendliness, as experienced by first-time and non-first-time users of the device. A prospective, descriptive study was carried out at the University Hospitals Leuven, Belgium. Five hundred PPS needles were individually evaluated in cancer patients. Different aspects of the PPS were assessed: packaging, needle insertion, and needle removal. Nurses were asked whether they had previously inserted or removed this type of needle. We compared the PPS needle with the standard Gripper® needle in terms of safety, ease of use, and ease of training. Three hundred sixty-six evaluation forms were available for analysis (73.2%). Packaging and access evaluations were scored positively, except for two aspects: (1) needle stability, and (2) ease of dressing. Ease of removal was scored unsatisfactory in up to 22.4% of the registrations. Pain at insertion was reported in about 20% registrations, and blood contact was reported by 2.5% of non-first-time users. Safety was scored as good, although ease of use and ease in training scored 25.4% and 43.8%, respectively, lower than the Gripper®. In general, nurses evaluated the PPS positively, with the exception of needle stability, ease of dressing, and ease of removal. No needlestick accidents were recorded. Aspects of ease of use and ease of training for PPS needles scored less than those for the Gripper® needles in up to one-third of the registrations.

48 CFR 852.214-73 - Alternate packaging and packing.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Alternate packaging and....214-73 Alternate packaging and packing. As prescribed in 814.201-6(b)(3), insert the following provision: Alternate Packaging and Packing (JAN 2008) The bidder's offer must clearly indicate the quantity...

Differences in the Language and Design of Four PPIs for Valium. Technical Assistance Report No. 1.

ERIC Educational Resources Information Center

Redish, Janice C.

As part of the evaluation of four different versions of a patient package insert (PPI) for diazepam (Valium) created by the Food and Drug Administration (FDA), the content, organization, language, and design of the PPIs were compared. One PPI was a short prose piece with clear organization that did not particularly highlight warnings or, indeed,…

Watermarking spot colors in packaging

NASA Astrophysics Data System (ADS)

Reed, Alastair; Filler, TomáÅ.¡; Falkenstern, Kristyn; Bai, Yang

2015-03-01

In January 2014, Digimarc announced Digimarc® Barcode for the packaging industry to improve the check-out efficiency and customer experience for retailers. Digimarc Barcode is a machine readable code that carries the same information as a traditional Universal Product Code (UPC) and is introduced by adding a robust digital watermark to the package design. It is imperceptible to the human eye but can be read by a modern barcode scanner at the Point of Sale (POS) station. Compared to a traditional linear barcode, Digimarc Barcode covers the whole package with minimal impact on the graphic design. This significantly improves the Items per Minute (IPM) metric, which retailers use to track the checkout efficiency since it closely relates to their profitability. Increasing IPM by a few percent could lead to potential savings of millions of dollars for retailers, giving them a strong incentive to add the Digimarc Barcode to their packages. Testing performed by Digimarc showed increases in IPM of at least 33% using the Digimarc Barcode, compared to using a traditional barcode. A method of watermarking print ready image data used in the commercial packaging industry is described. A significant proportion of packages are printed using spot colors, therefore spot colors needs to be supported by an embedder for Digimarc Barcode. Digimarc Barcode supports the PANTONE spot color system, which is commonly used in the packaging industry. The Digimarc Barcode embedder allows a user to insert the UPC code in an image while minimizing perceptibility to the Human Visual System (HVS). The Digimarc Barcode is inserted in the printing ink domain, using an Adobe Photoshop plug-in as the last step before printing. Since Photoshop is an industry standard widely used by pre-press shops in the packaging industry, a Digimarc Barcode can be easily inserted and proofed.

Recommendations for the use of medications with continuous enteral nutrition.

PubMed

Wohlt, Paul D; Zheng, Lan; Gunderson, Shelly; Balzar, Sarah A; Johnson, Benjamin D; Fish, Jeffrey T

2009-08-15

Recommendations for the use of medications with continuous enteral nutrition are provided. A literature review was conducted to identify primary literature reporting medication interactions with continuous enteral nutrition. For medications without supporting literature, manufacturers were contacted for information. Package inserts for specific medications were also investigated for any information to help guide recommendations. If no specific recommendations were made by the pharmaceutical manufacturer or the package insert concerning administration of products with continuous enteral nutrition, a tertiary database was consulted. Recommendations were generated by a consensus of clinicians for those medications that lacked specific recommendations in the primary literature or from the pharmaceutical manufacturer. Documentation of medication interactions with continuous enteral nutrition and food was then collated along with specific recommendations on how to administer the medication with regard to continuous enteral nutrition. Recommendations were classified as strong (grade 1) or weak (grade 2). The quality of evidence was classified as high (grade A), moderate (grade B), or low (grade C). Forty-six medications commonly given to hospitalized patients were evaluated. Twenty-four medications had recommendations based on available data, and the remaining 22 medications had recommendations based on a consensus of clinicians. There was a lack of published data regarding drug-nutrient interactions for a majority of the drugs commonly administered to patients receiving continuous enteral nutrition. Clinicians should recognize potential drug-nutrient interactions and use available evidence to optimize patients' drug therapy.

48 CFR 1852.211-70 - Packaging, handling, and transportation.

Code of Federal Regulations, 2010 CFR

2010-10-01

... transportation. 1852.211-70 Section 1852.211-70 Federal Acquisition Regulations System NATIONAL AERONAUTICS AND... and Clauses 1852.211-70 Packaging, handling, and transportation. As prescribed in 1811.404-70, insert the following clause: Packaging, Handling, and Transportation (SEPT 2005) (a) The Contractor shall...

48 CFR 1852.211-70 - Packaging, handling, and transportation.

Code of Federal Regulations, 2012 CFR

2012-10-01

... transportation. 1852.211-70 Section 1852.211-70 Federal Acquisition Regulations System NATIONAL AERONAUTICS AND... and Clauses 1852.211-70 Packaging, handling, and transportation. As prescribed in 1811.404-70, insert the following clause: Packaging, Handling, and Transportation (SEP 2005) (a) The Contractor shall...

48 CFR 1852.211-70 - Packaging, handling, and transportation.

Code of Federal Regulations, 2013 CFR

2013-10-01

... transportation. 1852.211-70 Section 1852.211-70 Federal Acquisition Regulations System NATIONAL AERONAUTICS AND... and Clauses 1852.211-70 Packaging, handling, and transportation. As prescribed in 1811.404-70, insert the following clause: Packaging, Handling, and Transportation (SEP 2005) (a) The Contractor shall...

48 CFR 1852.211-70 - Packaging, handling, and transportation.

Code of Federal Regulations, 2014 CFR

2014-10-01

... transportation. 1852.211-70 Section 1852.211-70 Federal Acquisition Regulations System NATIONAL AERONAUTICS AND... and Clauses 1852.211-70 Packaging, handling, and transportation. As prescribed in 1811.404-70, insert the following clause: Packaging, Handling, and Transportation (SEP 2005) (a) The Contractor shall...

21 CFR 516.165 - Records and reports.

Code of Federal Regulations, 2014 CFR

2014-04-01

... within 60 days thereafter. The report must contain data and information for the full reporting period..., include a summary of those changes and the holder's and distributor's current package labeling, including any package inserts. For large-size package labeling or large shipping cartons, submit a...

21 CFR 516.165 - Records and reports.

Code of Federal Regulations, 2012 CFR

2012-04-01

... within 60 days thereafter. The report must contain data and information for the full reporting period..., include a summary of those changes and the holder's and distributor's current package labeling, including any package inserts. For large-size package labeling or large shipping cartons, submit a...

Readability of medicinal package leaflets: a systematic review.

PubMed

Pires, Carla; Vigário, Marina; Cavaco, Afonso

2015-01-01

OBJECTIVE To review studies on the readability of package leaflets of medicinal products for human use. METHODS We conducted a systematic literature review between 2008 and 2013 using the keywords "Readability and Package Leaflet" and "Readability and Package Insert" in the academic search engine Biblioteca do Conhecimento Online, comprising different bibliographic resources/databases. The preferred reporting items for systematic reviews and meta-analyses criteria were applied to prepare the draft of the report. Quantitative and qualitative original studies were included. Opinion or review studies not written in English, Portuguese, Italian, French, or Spanish were excluded. RESULTS We identified 202 studies, of which 180 were excluded and 22 were enrolled [two enrolling healthcare professionals, 10 enrolling other type of participants (including patients), three focused on adverse reactions, and 7 descriptive studies]. The package leaflets presented various readability problems, such as complex and difficult to understand texts, small font size, or few illustrations. The main methods to assess the readability of the package leaflet were usability tests or legibility formulae. Limitations with these methods included reduced number of participants; lack of readability formulas specifically validated for specific languages (e.g., Portuguese); and absence of an assessment on patients literacy, health knowledge, cognitive skills, levels of satisfaction, and opinions. CONCLUSIONS Overall, the package leaflets presented various readability problems. In this review, some methodological limitations were identified, including the participation of a limited number of patients and healthcare professionals, the absence of prior assessments of participant literacy, humor or sense of satisfaction, or the predominance of studies not based on role-plays about the use of medicines. These limitations should be avoided in future studies and be considered when interpreting the results.

The NASA Electronic Parts and Packaging (NEPP) Program: Insertion of New Electronics Technologies

NASA Technical Reports Server (NTRS)

LaBel, Kenneth A.; Sampson, Michael J.

2007-01-01

This viewgraph presentation gives an overview of NASA Electronic Parts and Packaging (NEPP) Program's new electronics technology trends. The topics include: 1) The Changing World of Radiation Testing of Memories; 2) Even Application-Specific Tests are Costly!; 3) Hypothetical New Technology Part Qualification Cost; 4) Where we are; 5) Approaching FPGAs as a More Than a "Part" for Reliability; 6) FPGAs Beget Novel Radiation Test Setups; 7) Understanding the Complex Radiation Data; 8) Tracking Packaging Complexity and Reliability for FPGAs; 9) Devices Supporting the FPGA Need to be Considered; 10) Summary of the New Electronic Technologies and Insertion into Flight Programs Workshop; and 11) Highlights of Panel Notes and Comments

ProtSqueeze: simple and effective automated tool for setting up membrane protein simulations.

PubMed

Yesylevskyy, Semen O

2007-01-01

The major challenge in setting up membrane protein simulations is embedding the protein into the pre-equilibrated lipid bilayer. Several techniques were proposed to achieve optimal packing of the lipid molecules around the protein. However, all of them possess serious disadvantages, which limit their applicability and discourage the users of simulation packages from using them. In the present work, we analyzed existing approaches and proposed a new procedure of protein insertion into the lipid bilayer, which is implemented in the ProtSqueeze software. The advantages of ProtSqueeze are as follows: (1) the insertion algorithm is simple, understandable, and controllable; (2) the software can work with virtually any simulation package on virtually any platform; (3) no modification of the source code of the simulation package is needed; (4) the procedure of insertion is as automated as possible; (5) ProtSqueeze is distributed for free under a general public license. In this work, we present the architecture and the algorithm of ProtSqueeze and demonstrate its usage in case studies.

Keeping waived tests simple.

PubMed

2004-01-01

Laboratories performing waived testing must follow the manufacturer's instructions as well as good laboratory practices to ensure that test results are reliable. Four things to concentrate on to maximize the performance and reliability of waived tests are to: 1. Read and follow the information found in the package inserts. 2. Follow the manufacturer's recommendations for running quality control. 3. Train staff members to perform tests correctly. 4. Follow established policies and procedures for patient testing in the practice.

48 CFR 552.211-89 - Non-manufactured wood packaging material for export.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 48 Federal Acquisition Regulations System 4 2012-10-01 2012-10-01 false Non-manufactured wood... and Clauses 552.211-89 Non-manufactured wood packaging material for export. As prescribed in 511.204(b)(4), insert the following clause: Non-Manufactured Wood Packaging Material for Export (JAN 2010) (a...

48 CFR 552.211-89 - Non-manufactured wood packaging material for export.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 48 Federal Acquisition Regulations System 4 2014-10-01 2014-10-01 false Non-manufactured wood... and Clauses 552.211-89 Non-manufactured wood packaging material for export. As prescribed in 511.204(b)(4), insert the following clause: Non-Manufactured Wood Packaging Material for Export (JAN 2010) (a...

48 CFR 552.211-89 - Non-manufactured wood packaging material for export.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 48 Federal Acquisition Regulations System 4 2013-10-01 2013-10-01 false Non-manufactured wood... and Clauses 552.211-89 Non-manufactured wood packaging material for export. As prescribed in 511.204(b)(4), insert the following clause: Non-Manufactured Wood Packaging Material for Export (JAN 2010) (a...

48 CFR 552.211-89 - Non-manufactured wood packaging material for export.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 48 Federal Acquisition Regulations System 4 2011-10-01 2011-10-01 false Non-manufactured wood... and Clauses 552.211-89 Non-manufactured wood packaging material for export. As prescribed in 511.204(b)(4), insert the following clause: Non-Manufactured Wood Packaging Material for Export (JAN 2010) (a...

48 CFR 552.211-89 - Non-manufactured wood packaging material for export.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 4 2010-10-01 2010-10-01 false Non-manufactured wood... and Clauses 552.211-89 Non-manufactured wood packaging material for export. As prescribed in 511.204(b)(4), insert the following clause: Non-Manufactured Wood Packaging Material for Export (JAN 2010) (a...

Low-profile fiber connector for co-packaged optics

NASA Astrophysics Data System (ADS)

Brusberg, Lars; DeJong, Michael; Butler, Douglas L.; Clark, Jeffrey S.; Sutton, Clifford G.

2018-02-01

We developed a small form factor connector that can be assembled on all four sides of a high-data switch package for fiber connectivity. This paper discusses a novel connector approach that has the potential to meet all co-packaging requirements including solder-reflow-compatibility, de-mateability, low insertion loss and state-of-the art FAU attach. The connector was attached to the PIC for performance evaluation. The average insertion loss across all eight fibers of the assembly was 1.77 dB, including the three optical interfaces: (1) MT-to-MT between connector and receptacle, (2) receptacle-to-PLC and (3) PIC-to-FAU. Also included is the propagation loss of the PIC waveguide. Optical return loss was measured to be -55 dB or lower.

Cigarette package inserts can promote efficacy beliefs and sustained smoking cessation attempts: A longitudinal assessment of an innovative policy in Canada

PubMed Central

Thrasher, James F.; Swayampakala, Kamala; Cummings, K. Michael; Hammond, David; Anshari, Dien; Krugman, Dean M.; Hardin, James W.

2016-01-01

Background In June 2012, Canada implemented new pictorial warnings on cigarette packages, along with package inserts with messages to promote response efficacy (i.e., perceived quitting benefits) and self-efficacy (i.e., confidence to quit). This study assessed smokers’ attention towards warnings and inserts and its relationship with efficacy beliefs, risk perceptions and cessation at follow-up. Methods Data were analysed in 2015 from a prospective online consumer panel of adult Canadian smokers surveyed every four months between September 2012 and September 2014. Generalized Estimating Equation models assessed associations between reading inserts, reading warnings and efficacy beliefs (self-efficacy, response efficacy), risk perceptions, quit attempts of any length, and sustained quit attempts (i.e., 30 days or more) at follow-up. Models adjusted for socio-demographics, smoking-related variables, and time-in-sample effects. Results Over the study period, reading warnings significantly decreased (p<0.0001) while reading inserts increased (p=0.004). More frequent reading of warnings was associated independently with stronger response efficacy (Boften/very often vs never=0.28, 95% CI: 0.11–0.46) and risk perceptions at follow-up (Boften/very often vs never=0.31, 95% CI: 0.06–0.56). More frequent reading of inserts was associated independently with stronger self-efficacy to quit at follow-up (Btwice or more vs none=0.30, 95% CI: 0.14–0.47), quit attempts (ORtwice or more vs none= 1.68, 95% CI: 1.28–2.19), and quit attempts lasting 30 days or longer (ORtwice or more vs none=1.48, 95% CI: 1.01 – 2.17). Conclusions More frequent reading of inserts was associated with self-efficacy to quit, quit attempts, and sustained quitting at follow-up, suggesting that inserts complement pictorial HWLs. PMID:26970037

40 CFR 60.431 - Definitions and notations.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 6 2011-07-01 2011-07-01 false Definitions and notations. 60.431 Section 60.431 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS..., package inserts, book jackets, market circulars, magazine inserts, and shopping news, Newspapers, magazine...

40 CFR 60.431 - Definitions and notations.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 7 2012-07-01 2012-07-01 false Definitions and notations. 60.431 Section 60.431 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS..., package inserts, book jackets, market circulars, magazine inserts, and shopping news, Newspapers, magazine...

40 CFR 60.431 - Definitions and notations.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 7 2014-07-01 2014-07-01 false Definitions and notations. 60.431 Section 60.431 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS..., package inserts, book jackets, market circulars, magazine inserts, and shopping news, Newspapers, magazine...

40 CFR 60.431 - Definitions and notations.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 6 2010-07-01 2010-07-01 false Definitions and notations. 60.431 Section 60.431 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS..., package inserts, book jackets, market circulars, magazine inserts, and shopping news, Newspapers, magazine...

40 CFR 60.431 - Definitions and notations.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 7 2013-07-01 2013-07-01 false Definitions and notations. 60.431 Section 60.431 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS..., package inserts, book jackets, market circulars, magazine inserts, and shopping news, Newspapers, magazine...

Malaria rapid diagnostic kits: quality of packaging, design and labelling of boxes and components and readability and accuracy of information inserts.

PubMed

Gillet, Philippe; Maltha, Jessica; Hermans, Veerle; Ravinetto, Raffaella; Bruggeman, Cathrien; Jacobs, Jan

2011-02-13

The present study assessed malaria RDT kits for adequate and correct packaging, design and labelling of boxes and components. Information inserts were studied for readability and accuracy of information. Criteria for packaging, design, labelling and information were compiled from Directive 98/79 of the European Community (EC), relevant World Health Organization (WHO) documents and studies on end-users' performance of RDTs. Typography and readability level (Flesch-Kincaid grade level) were assessed. Forty-two RDT kits from 22 manufacturers were assessed, 35 of which had evidence of good manufacturing practice according to available information (i.e. CE-label affixed or inclusion in the WHO list of ISO13485:2003 certified manufacturers). Shortcomings in devices were (i) insufficient place for writing sample identification (n=40) and (ii) ambiguous labelling of the reading window (n=6). Buffer vial labels were lacking essential information (n=24) or were of poor quality (n=16). Information inserts had elevated readability levels (median Flesch Kincaid grade 8.9, range 7.1-12.9) and user-unfriendly typography (median font size 8, range 5-10). Inadequacies included (i) no referral to biosafety (n=18), (ii) critical differences between depicted and real devices (n=8), (iii) figures with unrealistic colours (n=4), (iv) incomplete information about RDT line interpretations (n=31) and no data on test characteristics (n=8). Other problems included (i) kit names that referred to Plasmodium vivax although targeting a pan-species Plasmodium antigen (n=4), (ii) not stating the identity of the pan-species antigen (n=2) and (iii) slight but numerous differences in names displayed on boxes, device packages and information inserts. Three CE labelled RDT kits produced outside the EC had no authorized representative affixed and the shape and relative dimensions of the CE symbol affixed did not comply with the Directive 98/79/EC. Overall, RDTs with evidence of GMP scored better compared to those without but inadequacies were observed in both groups. Overall, malaria RDTs showed shortcomings in quality of construction, design and labelling of boxes, device packages, devices and buffers. Information inserts were difficult to read and lacked relevant information.

48 CFR 52.247-65 - F.o.b. Origin, Prepaid Freight-Small Package Shipments.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 2 2010-10-01 2010-10-01 false F.o.b. Origin, Prepaid... Text of Provisions and Clauses 52.247-65 F.o.b. Origin, Prepaid Freight—Small Package Shipments. As prescribed in 47.303-17(f), insert the following clause: F.o.b. Origin Prepaid Freight—Small Package...

Packaging double-helical DNA into viral capsids.

PubMed

LaMarque, Jaclyn C; Le, Thuc-Vy L; Harvey, Stephen C

2004-02-15

DNA packaging in bacteriophage P4 has been examined using a molecular mechanics model with a reduced representation containing one pseudoatom per turn of the double helix. The model is a discretized version of an elastic continuum model. The DNA is inserted piecewise into the model capsid, with the structure being reoptimized after each piece is inserted. Various optimization protocols were investigated, and it was found that molecular dynamics at a very low temperature (0.3 K) produces the optimal packaged structure. This structure is a concentric spool, rather than the coaxial spool that has been commonly accepted for so many years. This geometry, which was originally suggested by Hall and Schellman in 1982 (Biopolymers Vol. 21, pp. 2011-2031), produces a lower overall elastic energy than coaxial spooling. Copyright 2003 Wiley Periodicals, Inc.

Investigating the Correlation Between Pharmacy Student Performance on the Health Science Reasoning Test and a Critical Thinking Assignment.

PubMed

Nornoo, Adwoa O; Jackson, Jonathan; Axtell, Samantha

2017-03-25

Objective. To determine whether there is a correlation between pharmacy students' scores on the Health Science Reasoning Test (HSRT) and their grade on a package insert assignment designed to assess critical thinking. Methods. The HSRT was administered to first-year pharmacy students during a critical-thinking course in the spring semester. In the same semester, a required package insert assignment was completed in a pharmacokinetics course. To determine whether there was a relationship between HSRT scores and grades on the assignment, a Spearman's rho correlation test was performed. Results. A very weak but significant positive correlation was found between students' grades on the assignment and their overall HSRT score (r=0.19, p <0.05), as well as deduction (a scale score of the HSRT; r=0.26, p <0.01). Conclusion. Based on a very weak but significant correlation to HSRT scores, this study demonstrated the potential of a package insert assignment to be used as one of the components to measure critical-thinking skills in pharmacy students.

Investigating the Correlation Between Pharmacy Student Performance on the Health Science Reasoning Test and a Critical Thinking Assignment

PubMed Central

Jackson, Jonathan; Axtell, Samantha

2017-01-01

Objective. To determine whether there is a correlation between pharmacy students’ scores on the Health Science Reasoning Test (HSRT) and their grade on a package insert assignment designed to assess critical thinking. Methods. The HSRT was administered to first-year pharmacy students during a critical-thinking course in the spring semester. In the same semester, a required package insert assignment was completed in a pharmacokinetics course. To determine whether there was a relationship between HSRT scores and grades on the assignment, a Spearman’s rho correlation test was performed. Results. A very weak but significant positive correlation was found between students’ grades on the assignment and their overall HSRT score (r=0.19, p<0.05), as well as deduction (a scale score of the HSRT; r=0.26, p<0.01). Conclusion. Based on a very weak but significant correlation to HSRT scores, this study demonstrated the potential of a package insert assignment to be used as one of the components to measure critical-thinking skills in pharmacy students. PMID:28381884

Pilot Fullerton uses water dispenser kit gun to rehydrate food package

NASA Image and Video Library

1982-03-30

STS003-26-254 (30 March 1982) --- Astronaut Gordon Fullerton, STS-3 pilot, wearing communications kit assembly (ASSY) mini-headset (HDST), inserts the JSC water dispenser kit water gun in rehydratable plastic food (cereal) package to fill it with hot water. Photo credit: NASA

Health Instruction Packages: Specific Nursing Skills.

ERIC Educational Resources Information Center

Bates, Clarice; And Others

Text, illustrations, and exercises are utilized in a set of five learning modules designed to instruct nursing students in a variety of clinical skills. The first module, "Down the Tube: Insertion of a Nasogastric Tube" by Clarice Bates, describes materials and procedures used to insert a nasogastric tube through the nose and esophagus…

Dual Use of Packaging on the Moon: Logistics-2-Living

NASA Technical Reports Server (NTRS)

Howe, A. Scott; Howard, Robert

2010-01-01

This paper describes a modular packaging system for logistics that can be reconfigured into internal outfitting for a lunar outpost, including desks, chairs, partitions, cabinets, and radiation shielding. Logistics include clothes, equipment, food, and other consumables needed to sustain the crew for the duration of the mission. A significant mass penalty is required for the packaging and handling of logistics for re-supply of short to long-term space missions that must be brought out of the gravity well on a launch vehicle. Once the supplies have been exhausted, the packaging material is typically of no further use and is discarded. If a scheme can be developed that reuses the logistics packaging, the mass penalty can be reduced. In this research, a modular packaging system has been devised as a kit-of-parts that can be used for both handling logistics supplies, and then reconfigured into desks, chairs, partitions, cabinets, and radiation shielding. The system is derived from a standard International Space Station (ISS)-type Cargo Transfer Bag (CTB), using soft, unfoldable box-like containers with stiff metal inserts. The empty hydrogen-impregnated CTBs can be used as-is for cabinets, opened up for use as partitions, or draped over the habitat as layers of radiation shielding. Stiff metal inserts can be reconfigured into desks and other useful outfitting.

Reliability Technology to Achieve Insertion of Advanced Packaging (RELTECH) program

NASA Astrophysics Data System (ADS)

Fayette, Daniel F.; Speicher, Patricia; Stoklosa, Mark J.; Evans, Jillian V.; Evans, John W.; Gentile, Mike; Pagel, Chuck A.; Hakim, Edward

1993-08-01

A joint military-commercial effort to evaluate multichip module (MCM) structures is discussed. The program, Reliability Technology to Achieve Insertion of Advanced Packaging (RELTECH), has been designed to identify the failure mechanisms that are possible in MCM structures. The RELTECH test vehicles, technical assessment task, product evaluation plan, reliability modeling task, accelerated and environmental testing, and post-test physical analysis and failure analysis are described. The information obtained through RELTECH can be used to address standardization issues, through development of cost effective qualification and appropriate screening criteria, for inclusion into a commercial specification and the MIL-H-38534 general specification for hybrid microcircuits.

Reliability Technology to Achieve Insertion of Advanced Packaging (RELTECH) program

NASA Technical Reports Server (NTRS)

Fayette, Daniel F.; Speicher, Patricia; Stoklosa, Mark J.; Evans, Jillian V.; Evans, John W.; Gentile, Mike; Pagel, Chuck A.; Hakim, Edward

1993-01-01

A joint military-commercial effort to evaluate multichip module (MCM) structures is discussed. The program, Reliability Technology to Achieve Insertion of Advanced Packaging (RELTECH), has been designed to identify the failure mechanisms that are possible in MCM structures. The RELTECH test vehicles, technical assessment task, product evaluation plan, reliability modeling task, accelerated and environmental testing, and post-test physical analysis and failure analysis are described. The information obtained through RELTECH can be used to address standardization issues, through development of cost effective qualification and appropriate screening criteria, for inclusion into a commercial specification and the MIL-H-38534 general specification for hybrid microcircuits.

Malaria rapid diagnostic kits: quality of packaging, design and labelling of boxes and components and readability and accuracy of information inserts

PubMed Central

2011-01-01

Background The present study assessed malaria RDT kits for adequate and correct packaging, design and labelling of boxes and components. Information inserts were studied for readability and accuracy of information. Methods Criteria for packaging, design, labelling and information were compiled from Directive 98/79 of the European Community (EC), relevant World Health Organization (WHO) documents and studies on end-users' performance of RDTs. Typography and readability level (Flesch-Kincaid grade level) were assessed. Results Forty-two RDT kits from 22 manufacturers were assessed, 35 of which had evidence of good manufacturing practice according to available information (i.e. CE-label affixed or inclusion in the WHO list of ISO13485:2003 certified manufacturers). Shortcomings in devices were (i) insufficient place for writing sample identification (n = 40) and (ii) ambiguous labelling of the reading window (n = 6). Buffer vial labels were lacking essential information (n = 24) or were of poor quality (n = 16). Information inserts had elevated readability levels (median Flesch Kincaid grade 8.9, range 7.1 - 12.9) and user-unfriendly typography (median font size 8, range 5 - 10). Inadequacies included (i) no referral to biosafety (n = 18), (ii) critical differences between depicted and real devices (n = 8), (iii) figures with unrealistic colours (n = 4), (iv) incomplete information about RDT line interpretations (n = 31) and no data on test characteristics (n = 8). Other problems included (i) kit names that referred to Plasmodium vivax although targeting a pan-species Plasmodium antigen (n = 4), (ii) not stating the identity of the pan-species antigen (n = 2) and (iii) slight but numerous differences in names displayed on boxes, device packages and information inserts. Three CE labelled RDT kits produced outside the EC had no authorized representative affixed and the shape and relative dimensions of the CE symbol affixed did not comply with the Directive 98/79/EC. Overall, RDTs with evidence of GMP scored better compared to those without but inadequacies were observed in both groups. Conclusion Overall, malaria RDTs showed shortcomings in quality of construction, design and labelling of boxes, device packages, devices and buffers. Information inserts were difficult to read and lacked relevant information. PMID:21314992

Packaging of microwave integrated circuits operating beyond 100 GHz

NASA Technical Reports Server (NTRS)

Samoska, L.; Daniel, E.; Sokolov, V.; Sommerfeldt, S.; Bublitz, J.; Olson, K.; Gilbert, B.; Chow, D.

2002-01-01

Several methods of packaging high speed (75-330 GHz) InP HEMT MMIC devices are discussed. Coplanar wirebonding is presented with measured insertion loss of less than 0.5dB and return loss better than -17 dB from DC to 110 GHz. A motherboard/daughterboard packaging scheme is presented which supports minimum loss chains of MMICs using this coplanar wirebonding method. Split waveguide block packaging approaches are presented in G-band (140-220 GHz) with two types of MMIC-waveguide transitions: E-plane probe andantipodal finline.

Method of fabricating a microelectronic device package with an integral window

DOEpatents

Peterson, Kenneth A.; Watson, Robert D.

2003-01-01

A method of fabricating a microelectronic device package with an integral window for providing optical access through an aperture in the package. The package is made of a multilayered insulating material, e.g., a low-temperature cofired ceramic (LTCC) or high-temperature cofired ceramic (HTCC). The window is inserted in-between personalized layers of ceramic green tape during stackup and registration. Then, during baking and firing, the integral window is simultaneously bonded to the sintered ceramic layers of the densified package. Next, the microelectronic device is flip-chip bonded to cofired thick-film metallized traces on the package, where the light-sensitive side is optically accessible through the window. Finally, a cover lid is attached to the opposite side of the package. The result is a compact, low-profile package, flip-chip bonded, hermetically-sealed package having an integral window.

Understanding risk evaluation and mitigation strategies in organ transplantation.

PubMed

Gabardi, Steven

2011-07-01

The United States Food and Drug Administration (FDA) Amendments Act of 2007 mandated that Risk Evaluation and Mitigation Strategies (REMS) be required of manufacturers. These REMS are strategies implemented to manage known or potential risks associated with drugs and to ensure ongoing pharmacovigilance throughout the life of a pharmaceutical product, including once the product becomes available as generic. The elements of an individual REMS program consist of three levels: medication guide or patient package insert, communication plan, and elements to assure safe use (ETASU). A medication guide or patient package insert is used to help prevent serious adverse events, aid in patient decision making, and enhance drug adherence. Communication plans are used to educate health care providers and to encourage their compliance with REMS. The ETASU is a restrictive process that is implemented when it is deemed necessary to ensure that patients have safe access to products with known serious risks that would otherwise be unavailable. To review the components of REMS and specifically assess their impact on health care providers practicing within the organ transplantation arena, a literature search of the MEDLINE database (January 2007-December 2010) was performed, and published materials from the FDA and its Web site were also reviewed. In transplantation, REMS programs exist for both everolimus (medication guide and communication plan) and sirolimus (medication guide). The FDA has stated that all mycophenolic acid derivatives will be subject to a proposed REMS that has not yet been approved; however, both branded mycophenolic acid agents already have approved medication guides. The REMS are a permanent fixture in the development and marketing of pharmaceutical agents, and their further implementation in solid organ transplantation is inevitable. Transplantation providers should take a proactive role in patient education and implementation of REMS within the therapeutic area. It is imperative for health care providers to realize that the ultimate goals of REMS are to reduce the potential for serious risks and to make outcomes from the treatment of disease more predictable.

Testing Cessation Messages for Cigarette Package Inserts: Findings from a Best/Worst Discrete Choice Experiment

PubMed Central

Thrasher, James F.; Davis, Rachel E.; Popova, Lucy; Cho, Yoo Jin; Salloum, Ramzi G.; Louviere, Jordan; Hammond, David

2018-01-01

This study assessed smokers’ responses to different smoking cessation topics and imagery for cigarette package inserts. Adult smokers from Canada (n = 1000) participated in three discrete choice experiments (DCEs): DCE 1 assessed five cessation benefit topics and five imagery types; DCE 2 assessed five messages with tips to improve cessation success and five imagery types; DCE 3 assessed four reproductive health benefits of cessation topics and four imagery types. In each DCE, participants evaluated four or five sets of four inserts, selecting the most and least motivating (DCEs 1 & 3) or helpful (DCE 2) for quitting. Linear mixed models regressed choices on insert and smoker characteristics. For DCE 1, the most motivating messages involved novel disease topics and imagery of younger women. For DCE 2, topics of social support, stress reduction and nicotine replacement therapy were selected as most helpful, with no differences by imagery type. For DCE 3, imagery influenced choices more than topic, with imagery of a family or a mom and baby selected as most motivating. Statistically significant interactions for all three experiments indicated that the influence of imagery type on choices depended on the message topic. Messages to promote smoking cessation through cigarette pack inserts should consider specific combinations of message topic and imagery. PMID:29415523

A Review of Patents for the Smart Packaging of Meat and Muscle-based Food Products.

PubMed

Holman, Benjamin; Kerry, Joseph P; Hopkins, David L

2017-10-31

Meat packaging once acted primarily as an inert barrier to protect its contents against contamination and this function has shifted. Packaging now includes complementary functions that improve product quality, longevity and customer/retail appeal. The devices and methods applied to achieve these functions may be categorised as smart packaging, which includes intelligent packaging, devised to monitor and communicate packaged content status, and active packaging, to provide passive adjustment of in-pack conditions from its interactions with the packaged meat. Smart packaging examples already available from recent patents include antimicrobial and antioxidant packaging coatings and inserts; sensors or indicators that identify spoilage and freshness; functional engineering customisations; improvements to packaging integrity; leak or tamper detectors; and, environmentally sustainable options. Together, these inventions respond to industry and customer demands for meat packaging and are therefore the focus of this review, in which we discuss their applications and limitations in meat packaging. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

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

"rsed" is an R package that contains tools for stream editing: manipulating text files by making insertions, replacements, deletions, substitutions, or commenting. It hails from the powerful Unix command, "sed". While the "rsed" package is not nearly as powerful as "see", it is much simpler to use. R programmers often write scripts that may require simple manipulation of text files. "rsed" addresses that need.

Microstructure-Evolution and Reliability Assessment Tool for Lead-Free Component Insertion in Army Electronics

DTIC Science & Technology

2008-10-01

provide adequate means for thermal heat dissipation and cooling. Thus electronic packaging has four main functions [1]: • Signal distribution which... dissipation , involving structural and materials consideration. • Mechanical, chemical and electromagnetic protection of components and... nature when compared to phenomenological models. Microelectronic packaging industry spends typically several months building and reliability

Patient understanding of oral contraceptive pill instructions related to missed pills: a systematic review.

PubMed

Zapata, Lauren B; Steenland, Maria W; Brahmi, Dalia; Marchbanks, Polly A; Curtis, Kathryn M

2013-05-01

Instructions on what to do after pills are missed are critical to reducing unintended pregnancies resulting from patient non-adherence to oral contraceptive (OC) regimens. Missed pill instructions have previously been criticized for being too complex, lacking a definition of what is meant by "missed pills," and for being confusing to women who may not know the estrogen content of their formulation. To help inform the development of missed pill guidance to be included in the forthcoming US Selected Practice Recommendations, the objective of this systematic review was to evaluate the evidence on patient understanding of missed pill instructions. We searched the PubMed database for peer-reviewed articles that examined patient understanding of OC pill instructions that were published in any language from inception of the database through March 2012. We included studies that examined women's knowledge and understanding of missed pill instructions after exposure to some written material (e.g., patient package insert, brochure), as well as studies that compared different types of missed pill instructions on women's comprehension. We used standard abstract forms and grading systems to summarize and assess the quality of the evidence. From 1620 articles, nine studies met our inclusion criteria. Evidence from one randomized controlled trial (RCT) and two descriptive studies found that more women knew what to do after missing 1 pill than after missing 2 or 3 pills (Level I, good, to Level II-3, poor), and two descriptive studies found that more women knew what to do after missing 2 pills than after missing 3 pills (Level II-3, fair). Data from two descriptive studies documented the difficulty women have understanding missed pill instructions contained in patient package inserts (Level II-3, poor), and evidence from two RCTs found that providing written brochures with information on missed pill instructions in addition to contraceptive counseling significantly improved knowledge of how to manage missed pills for up to three months compared to contraceptive counseling alone (Level I, fair). Evidence from one RCT found that graphic-based missed pill instructions were better than text-only instructions (Level I, good), and data from two RCTs found that less information resulted in improved comprehension (Level I, good to fair). Evidence from one descriptive study found that many women missing pills did not intend to follow recommended actions per missed pill instructions despite understanding the guidance (Level II-3, poor). There is wide variability in the percent of women having correct knowledge on what to do when pills are missed after exposure to written missed pills instructions, with more women knowing what to do after missing 1 pill than after missing 2 or 3 pills. Women have difficulty understanding missed pill instructions contained in patient package inserts. Providing written brochures with information on missed pill instructions in addition to contraceptive counseling may improve knowledge of how to manage missed pills. Graphic-based missed pill instructions and those containing less information may result in improved comprehension. Even with clear instructions, many women missing pills may choose not to follow the recommended actions. Published by Elsevier Inc.

Technical Note: Computer-Manufactured Inserts for Prosthetic Sockets

PubMed Central

Sanders, Joan E.; McLean, Jake B.; Cagle, John C.; Gardner, David W.; Allyn, Katheryn J.

2016-01-01

The objective of this research was to use computer-aided design software and a tabletop 3-D additive manufacturing system to design and fabricate custom plastic inserts for trans-tibial prosthesis users. Shape quality of inserts was tested right after they were inserted into participant’s test sockets and again after four weeks of wear. Inserts remained properly positioned and intact throughout testing. Right after insertion the inserts caused the socket to be slightly under-sized, by a mean of 0.11 mm, approximately 55% of the thickness of a nylon sheath. After four weeks of wear the under-sizing was less, averaging 0.03 mm, approximately 15% of the thickness of a nylon sheath. Thus the inserts settled into the sockets over time. If existing prosthetic design software packages were enhanced to conduct insert design and to automatically generate fabrication files for manufacturing, then computer manufactured inserts may offer advantages over traditional methods in terms of speed of fabrication, ease of design, modification, and record keeping. PMID:27212209

Reading about over-the-counter medications.

PubMed

Nabors, Laura A; Lehmkuhl, Heather D; Parkins, Irina S; Drury, Anna M

2004-01-01

Many adolescents and young adults purchase and use over-the-counter (OTC) medications, and some may take these medications without reading about how to use them. Most do read package inserts and labels to learn about the medication, but studies examining what influences label reading for youth are needed. This study assessed factors related to label reading for young people, including demographic variables (gender, health status) and the types of information they were seeking about the medication. Eight hundred and seventy-six high school and college students participated, and most reported reading labels or package inserts to learn about medications. Participants experiencing pain were more likely to read labels, except for those experiencing headaches who reported being less likely to read labels. When reading labels, participants were interested in information about side effects, ingredients, dosage instructions, and symptoms treated by the medication. Future research should examine whether youth take medications as directed and what factors make labels and inserts easier to read and understand.

Jig Aligns Shadow Mask On CCD

NASA Technical Reports Server (NTRS)

Matus, Carlos V.

1989-01-01

Alignment viewed through microscope. Alignment jig positions shadow mask on charge-coupled device (CCD) so metal film deposited on it precisely. Allows CCD package to be inserted and removed without disturbing alignment of mask. Holds CCD packages securely and isolates it electrostatically while providing electrical contact to each of its pins. When alignment jig assembled with CCD, used to move mask under micrometer control.

Using PATIMDB to Create Bacterial Transposon Insertion Mutant Libraries

PubMed Central

Urbach, Jonathan M.; Wei, Tao; Liberati, Nicole; Grenfell-Lee, Daniel; Villanueva, Jacinto; Wu, Gang; Ausubel, Frederick M.

2015-01-01

PATIMDB is a software package for facilitating the generation of transposon mutant insertion libraries. The software has two main functions: process tracking and automated sequence analysis. The process tracking function specifically includes recording the status and fates of multiwell plates and samples in various stages of library construction. Automated sequence analysis refers specifically to the pipeline of sequence analysis starting with ABI files from a sequencing facility and ending with insertion location identifications. The protocols in this unit describe installation and use of PATIMDB software. PMID:19343706

A Pre- and Post-Evaluation of Integrating Sustainability Curriculum by Inserting Okala Modules into an Interior Design Materials and Methods Course

ERIC Educational Resources Information Center

Schneiderman, Deborah; Freihoefer, Kara

2012-01-01

Purpose: The purpose of this paper is to examine the integration of Okala curriculum into Interior Design coursework. Okala, as a teaching package, is utilized extensively in industrial design education. However, this study examines the expansion and insertion of Okala modules in an existing interior design curriculum. The Okala modules included…

Dose-independent confusion induced by voriconazole in a patient with Asian ancestry after allogeneic hematopoietic stem cell transplant.

PubMed

Hui, John

2016-02-01

This is the case of a 71-year-old man with Asian ancestry who had myelodysplastic syndrome admitted for allogeneic hematopoietic stem cell transplant. This case suggests that voriconazole-induced confusion is probably dose-independent and reversible with no residual symptoms after discontinuation of voriconazole. Patient can experience confusion even voriconazole is ordered according to package insert and serum voriconazole level is within therapeutic range (1-6 µg/mL). The onset of confusion can be delayed and sudden after seven days of voriconazole therapy. Genotyping of CYP2C19 can be tested for Asian populations since 15-20% of them could be poor metabolizers of voriconazole. © The Author(s) 2014.

Technical note: Computer-manufactured inserts for prosthetic sockets.

PubMed

Sanders, Joan E; McLean, Jake B; Cagle, John C; Gardner, David W; Allyn, Katheryn J

2016-08-01

The objective of this research was to use computer-aided design software and a tabletop 3-D additive manufacturing system to design and fabricate custom plastic inserts for trans-tibial prosthesis users. Shape quality of inserts was tested right after they were inserted into participant's test sockets and again after four weeks of wear. Inserts remained properly positioned and intact throughout testing. Right after insertion the inserts caused the socket to be slightly under-sized, by a mean of 0.11mm, approximately 55% of the thickness of a nylon sheath. After four weeks of wear the under-sizing was less, averaging 0.03mm, approximately 15% of the thickness of a nylon sheath. Thus the inserts settled into the sockets over time. If existing prosthetic design software packages were enhanced to conduct insert design and to automatically generate fabrication files for manufacturing, then computer manufactured inserts may offer advantages over traditional methods in terms of speed of fabrication, ease of design, modification, and record keeping. Copyright © 2016 IPEM. Published by Elsevier Ltd. All rights reserved.

Young adult smokers' perceptions of plain packs, numbered packs and pack inserts in Turkey: a focus group study.

PubMed

Mucan, Burcu; Moodie, Crawford

2017-11-09

The Turkish Government's 'National Tobacco Control Program 2015-2018' included plans to introduce plain packaging and also a ban on brand names on cigarette packs, allowing only assigned numbers on packs. We explored perceptions of these proposed measures, and also pack inserts with cessation messages, another novel way of using the packaging to communicate with consumers. Eight focus groups were conducted with 47 young adult smokers in Manisa and Kutahya (Turkey) in December 2016. Participants were shown three straight-edged plain cigarette packs, as required in Australia, and then three bevelled-edged plain packs, as permitted in the UK. They were then shown plain packs with numbers rather than brand names, and finally three pack inserts with messages encouraging quitting or offering tips on how to do so. Participants were asked about their perceptions of each. Plain packs were considered unappealing and off-putting, although the bevelled-edged packs were viewed more favourably than the straight-edged packs. Numbered packs were thought by some to diminish the appeal created by the brand name and potentially decrease interest among never smokers and newer smokers. Pack inserts were thought to have less of an impact than the on-pack warnings, but could potentially help discourage initiation and encourage cessation. That bevelled-edged plain packs were perceived more positively than straight-edged plain packs is relevant to countries planning to introduce plain packaging. The study provides a first insight into smokers' perceptions of a ban on brand names, which was perceived to reduce appeal among young people. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Evaluation of strategies to communicate harmful and potentially harmful constituent (HPHC) information through cigarette package inserts: a discrete choice experiment.

PubMed

Salloum, Ramzi G; Louviere, Jordan J; Getz, Kayla R; Islam, Farahnaz; Anshari, Dien; Cho, Yoojin; O'Connor, Richard J; Hammond, David; Thrasher, James F

2017-07-13

The US Food and Drug Administration (FDA) has regulatory authority to use inserts to communicate with consumers about harmful and potentially harmful constituents (HPHCs) in tobacco products; however, little is known about the most effective manner for presenting HPHC information. In a discrete choice experiment, participants evaluated eight choice sets, each of which showed two cigarette packages from four different brands and tar levels (high vs low), accompanied by an insert that included between-subject manipulations (ie, listing of HPHCs vs grouping by disease outcome and numeric values ascribed to HPHCs vs no numbers) and within-subject manipulations (ie, 1 of 4 warning topics; statement linking an HPHC with disease vs statement with no HPHC link). For each choice set, participants were asked: (1) which package is more harmful and (2) which motivates them to not smoke; each with a 'no difference' option. Alternative-specific logit models regressed choice on attribute levels. 1212 participants were recruited from an online consumer panel (725 18-29-year-old smokers and susceptible non-smokers and 487 30-64-year-old smokers). Participants were more likely to endorse high-tar products as more harmful than low-tar products, with a greater effect when numeric HPHC information was present. Compared with a simple warning statement, the statement linking HPHCs with disease encouraged quit motivation. Numeric HPHC information on inserts appears to produce misunderstandings that some cigarettes are less harmful than others. Furthermore, brief narratives that link HPHCs to smoking-related disease may promote cessation versus communications that do not explicitly link HPHCs to disease. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Developing targets for radiation transport experiments at the Omega laser facility

DOE PAGES

Capelli, Deanna; Charsley-Groffman, C. A.; Randolph, Randall Blaine; ...

2017-07-13

Targets have been developed to measure supersonic radiation transport in aerogel foams using absorption spectroscopy. The target consists of an aerogel foam uniformly doped with either titanium or scandium inserted into an undoped aerogel foam package. This creates a localized doped foam region to provide spatial resolution for the measurement. Development and characterization of the foams is a key challenge in addition to machining and assembling the two foams so they mate without gaps. The foam package is inserted into a beryllium sleeve and mounted on a gold hohlraum. The target is mounted to a holder created using additive manufacturingmore » and mounted on a stalk. As a result, the manufacturing of the components, along with assembly and metrology of the target are described here.« less

Developing targets for radiation transport experiments at the Omega laser facility

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

Capelli, Deanna; Charsley-Groffman, C. A.; Randolph, Randall Blaine

Targets have been developed to measure supersonic radiation transport in aerogel foams using absorption spectroscopy. The target consists of an aerogel foam uniformly doped with either titanium or scandium inserted into an undoped aerogel foam package. This creates a localized doped foam region to provide spatial resolution for the measurement. Development and characterization of the foams is a key challenge in addition to machining and assembling the two foams so they mate without gaps. The foam package is inserted into a beryllium sleeve and mounted on a gold hohlraum. The target is mounted to a holder created using additive manufacturingmore » and mounted on a stalk. As a result, the manufacturing of the components, along with assembly and metrology of the target are described here.« less

The US Food and Drug Administration's Risk Evaluation and Mitigation Strategy (REMS) Program - Current Status and Future Direction.

PubMed

Wu, Jasmanda; Juhaeri, Juhaeri

2016-12-01

The US Food and Drug Administration (FDA) Amendments Act of 2007 granted the FDA new authorities to enhance drug safety by requiring application holders to submit a proposed Risk Evaluation and Mitigation Strategy (REMS). A REMS is a required risk management plan that uses tools beyond the package insert. REMS elements may include a medication guide and patient package insert for patients and a communication plan focused on health care professionals. Elements to assure safe use (ETASUs) are put in place to mitigate a specific known serious risk when other less restrictive elements of a REMS are not sufficient to mitigate such risk. An implementation system is required for an REMS that includes the ETASUs. With approximately eight years of experience with REMS programs, many health care settings have created systems to manage REMS and also to integrate REMS into their practice settings. At the same time, there are issues associated with the development and implementation of REMS. In 2011, FDA created the REMS Integration Initiative to develop guidance on how to apply statutory criteria to determine when a REMS is required, to improve standardization and assessment of REMS, and to improve integration of REMS into the existing healthcare system. A key component of the REMS Integration Initiative is stakeholder outreach to better understand how existing REMS programs are working and to identify opportunities for improvement. This review attempts to share our company's experience with the REMS program, and to provide updates on FDA's efforts to improve REMS communication, to standardize REMS process, to reduce REMS program burdens and to build a common REMS platform. Copyright © 2016 Elsevier HS Journals, Inc. All rights reserved.

Evaluation of Sensibility Threshold for Interocclusal Thickness of Patients Wearing Complete Dentures

PubMed Central

Shala, Kujtim Sh.; Ahmedi, Enis F.; Tmava-Dragusha, Arlinda

2017-01-01

Objective The aim of this study was to evaluate sensibility threshold for interocclusal thickness in experienced and nonexperienced denture wearers after the insertion of new complete dentures. Materials and Methods A total of 88 patients with complete dentures have participated in this study. The research was divided into two experimental groups, compared with the previous experience prosthetic dental treatment. The sensibility threshold for interocclusal thickness was measured with metal foil with 8 μm thickness and width of 8 mm, placed between the upper and lower incisor region. Statistical analysis was performed using standard software package BMDP (biomedical statistical package). Results Results suggest that time of measurement affects the average values of the sensibility threshold for interocclusal thickness (F = 242.68, p = 0.0000). Gender appeared to be a significant factor when it interacted with time measurement resulting in differences in sensibility threshold for interocclusal thickness (gender: F = 9.84, p = 0.018; F = 4.83, p = 0.0003). Conclusion The sensibility threshold for interocclusal thickness was the most important functional adaptation in patient with complete dentures. A unique trait of this indicator is the progressive reduction of initial values and a tendency to reestablish the stationary state in the fifteenth week after dentures is taken off. PMID:28702055

Pilot Fullerton prepares meal on middeck

NASA Image and Video Library

1982-03-30

STS003-26-253 (30 March 1982) --- Astronaut Gordon Fullerton, STS-3 pilot, wearing communications kit assembly (assy) mini-headset (HDST), prepares meal on middeck. Fullerton clips corner of rehydratable food (cereal) package with scissors. The opening will allow Fullerton to insert JSC water dispenser kit water gun in order to heat contents with hot water. Meal tray assembly is secured to forward middeck locker and holds additional food packages and beverage containers. Photo credit: NASA

Gluten content of medications.

PubMed

Cruz, Joseph E; Cocchio, Craig; Lai, Pak Tsun; Hermes-DeSantis, Evelyn

2015-01-01

The establishment of a database for the identification of the presence of gluten in excipients of prescription medications is described. While resources are available to ascertain the gluten content of a given medication, these resources are incomplete and often do not contain a source and date of contact. The drug information service (DIS) at Robert Wood Johnson University Hospital (RWJUH) determined that directly contacting the manufacturer of a product is the best method to determine the gluten content of medications. The DIS sought to establish a resource for use within the institution and create directions for obtaining this information from manufacturers to ensure uniformity of the data collected. To determine the gluten content of a medication, the DIS analyzed the manufacturer's package insert to identify any statement indicating that the product contained gluten or inactive ingredients from known sources of gluten. If there was any question about the source of an inactive ingredient or if no information about gluten content appeared in the package insert, the manufacturer of the particular formulation of the queried medication was contacted to provide clarification. Manufacturers' responses were collected, and medications were categorized as "gluten free," "contains gluten," or "possibly contains gluten." To date, the DIS at RWJUH has received queries about 84 medications and has cataloged their gluten content. The DIS at RWJUH developed a database that categorizes the gluten status of medications, allowing clinicians to easily identify drugs that are safe for patients with celiac disease. Copyright © 2015 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

Application of Au-Sn eutectic bonding in hermetic radio-frequency microelectromechanical system wafer level packaging

NASA Astrophysics Data System (ADS)

Wang, Qian; Choa, Sung-Hoon; Kim, Woonbae; Hwang, Junsik; Ham, Sukjin; Moon, Changyoul

2006-03-01

Development of packaging is one of the critical issues toward realizing commercialization of radio-frequency-microelectromechanical system (RF-MEMS) devices. The RF-MEMS package should be designed to have small size, hermetic protection, good RF performance, and high reliability. In addition, packaging should be conducted at sufficiently low temperature. In this paper, a low-temperature hermetic wafer level packaging scheme for the RF-MEMS devices is presented. For hermetic sealing, Au-Sn eutectic bonding technology at temperatures below 300°C is used. Au-Sn multilayer metallization with a square loop of 70 µm in width is performed. The electrical feed-through is achieved by the vertical through-hole via filling with electroplated Cu. The size of the MEMS package is 1 mm × 1 mm × 700 µm. The shear strength and hermeticity of the package satisfies the requirements of MIL-STD-883F. Any organic gases or contamination are not observed inside the package. The total insertion loss for the packaging is 0.075 dB at 2 GHz. Furthermore, the robustness of the package is demonstrated by observing no performance degradation and physical damage of the package after several reliability tests.

Development of Multifunctional Active Film and Its Application in Modified Atmosphere Packaging of Shiitake Mushrooms.

PubMed

Wang, Hong Jiang; An, Duck Soon; Lee, Dong Sun

2016-09-01

Agar-based films with multiple functions (CO 2 absorption, water vapor absorption, and antimicrobial activity) were developed, tested for their properties, and then applied to the packaging of fresh shiitake mushrooms as an insert label. The films were cast from an agar-based aqueous solution containing a dissolving plasticizer (glycerol), a CO 2 absorbent (sodium carbonate [SC] alone or a combination of SC and sodium glycinate [SC-SG]), and a volatile antimicrobial agent (carvacrol [CRV]). The agar of the film matrix is designed to serve as a water vapor absorbent. The multifunctional films tended to have poor mechanical properties, with a hard texture and an opaque and yellowish color. The CO 2 absorbent, either SC alone or SC-SG, affected CRV retention and release along with the CO 2 and water vapor absorption behavior. Both films (SC-CRV and SC-SG-CRV films) showed good inhibitory effects against Pseudomonas fluorescens and Saccharomyces cerevisiae . SC-CRV film had a higher and faster CO 2 absorption property, higher retention and extended release of CRV, and lower and slower water vapor absorption and was assessed to be better suited for use in shiitake mushroom packaging. The packaging in which the SC-CRV film with an appropriate amount of CRV was used as an insert label was able to generate the desired atmosphere and less moisture condensation inside the package, producing the best preservation of quality in terms of mushroom color, firmness, flavor score, and microbial counts after 6 days of storage at 10°C. A tailored modified atmosphere packaging system using multifunctional film would be useful in the preservation of CO 2 -sensitive fresh commodities.

The Ontology of Vaccine Adverse Events (OVAE) and its usage in representing and analyzing adverse events associated with US-licensed human vaccines.

PubMed

Marcos, Erica; Zhao, Bin; He, Yongqun

2013-11-26

Licensed human vaccines can induce various adverse events (AE) in vaccinated patients. Due to the involvement of the whole immune system and complex immunological reactions after vaccination, it is difficult to identify the relations among vaccines, adverse events, and human populations in different age groups. Many known vaccine adverse events (VAEs) have been recorded in the package inserts of US-licensed commercial vaccine products. To better represent and analyze VAEs, we developed the Ontology of Vaccine Adverse Events (OVAE) as an extension of the Ontology of Adverse Events (OAE) and the Vaccine Ontology (VO). Like OAE and VO, OVAE is aligned with the Basic Formal Ontology (BFO). The commercial vaccines and adverse events in OVAE are imported from VO and OAE, respectively. A new population term 'human vaccinee population' is generated and used to define VAE occurrence. An OVAE design pattern is developed to link vaccine, adverse event, vaccinee population, age range, and VAE occurrence. OVAE has been used to represent and classify the adverse events recorded in package insert documents of commercial vaccines licensed by the USA Food and Drug Administration (FDA). OVAE currently includes over 1,300 terms, including 87 distinct types of VAEs associated with 63 human vaccines licensed in the USA. For each vaccine, occurrence rates for every VAE in different age groups have been logically represented in OVAE. SPARQL scripts were developed to query and analyze the OVAE knowledge base data. To demonstrate the usage of OVAE, the top 10 vaccines accompanying with the highest numbers of VAEs and the top 10 VAEs most frequently observed among vaccines were identified and analyzed. Asserted and inferred ontology hierarchies classify VAEs in different levels of AE groups. Different VAE occurrences in different age groups were also analyzed. The ontology-based data representation and integration using the FDA-approved information from the vaccine package insert documents enables the identification of adverse events from vaccination in relation to predefined parts of the population (age groups) and certain groups of vaccines. The resulting ontology-based VAE knowledge base classifies vaccine-specific VAEs and supports better VAE understanding and future rational AE prevention and treatment.

9 CFR 381.123 - Official inspection mark; official establishment number.

Code of Federal Regulations, 2011 CFR

2011-01-01

... label of a canned product, or on other packaging or labeling in the container, e.g., on aluminum pans... insert label placed under a transparent covering if clearly visible and legible and accompanied by the...

9 CFR 381.123 - Official inspection mark; official establishment number.

Code of Federal Regulations, 2010 CFR

2010-01-01

... label of a canned product, or on other packaging or labeling in the container, e.g., on aluminum pans... insert label placed under a transparent covering if clearly visible and legible and accompanied by the...

Microbial viability in preparations packaged for single use.

PubMed

Obayashi, Akiko; Oie, Shigeharu; Kamiya, Akira

2003-05-01

We evaluated microbial viability in preparations packaged for single use only which mandate that residual solution be discarded such as albumin and globulin preparations as blood products, preparations containing albumin (such as urokinase and interferon), fat emulsions, and a preparation containing fat emulsions (propofol). In most preparations, Serratia marcescens and Burkholderia cepacia proliferated rapidly at 30 degrees C. However, in globulin preparations containing 1-2.25% glycine to prevent protein degradation (Gamma-Venin P, Venilon-I, Globulin Injection, and Ahlbulin), no growth of S. marcescens and B. cepacia was detected over 24 h at 30 degrees C. For globulin preparations containing 1-2.25% glycine, the injunction to "Discard residual solution after the package has been used" in the package inserts can be revised to "It is possible to use residual solution within 24 h after the package has been used with storage in a cool place."

Clinical psychopharmacology and medical malpractice: the four Ds.

PubMed

Preskorn, Sheldon H

2014-09-01

The four Ds of medical malpractice are duty, dereliction (negligence or deviation from the standard of care), damages, and direct cause. Each of these four elements must be proved to have been present, based on a preponderance of the evidence, for malpractice to be found. The principles of psychopharmacology and the information in the package insert for a drug often play a central role in deciding whether dereliction and direct cause for damages were or were not applicable in a particular case. The author uses data from two cases in which patients were inadvertently fatally poisoned by medication to illustrate two ways in which such information can affect the outcome. In one case, the clinician should have known that he was giving a toxic dose to the patient, whereas that was not true in the other case.

Method of forming a package for MEMS-based fuel cell

DOEpatents

Morse, Jeffrey D; Jankowski, Alan F

2013-05-21

A MEMS-based fuel cell package and method thereof is disclosed. The fuel cell package comprises seven layers: (1) a sub-package fuel reservoir interface layer, (2) an anode manifold support layer, (3) a fuel/anode manifold and resistive heater layer, (4) a Thick Film Microporous Flow Host Structure layer containing a fuel cell, (5) an air manifold layer, (6) a cathode manifold support structure layer, and (7) a cap. Fuel cell packages with more than one fuel cell are formed by positioning stacks of these layers in series and/or parallel. The fuel cell package materials such as a molded plastic or a ceramic green tape material can be patterned, aligned and stacked to form three dimensional microfluidic channels that provide electrical feedthroughs from various layers which are bonded together and mechanically support a MEMS-based miniature fuel cell. The package incorporates resistive heating elements to control the temperature of the fuel cell stack. The package is fired to form a bond between the layers and one or more microporous flow host structures containing fuel cells are inserted within the Thick Film Microporous Flow Host Structure layer of the package.

Method of forming a package for mems-based fuel cell

DOEpatents

Morse, Jeffrey D.; Jankowski, Alan F.

2004-11-23

A MEMS-based fuel cell package and method thereof is disclosed. The fuel cell package comprises seven layers: (1) a sub-package fuel reservoir interface layer, (2) an anode manifold support layer, (3) a fuel/anode manifold and resistive heater layer, (4) a Thick Film Microporous Flow Host Structure layer containing a fuel cell, (5) an air manifold layer, (6) a cathode manifold support structure layer, and (7) a cap. Fuel cell packages with more than one fuel cell are formed by positioning stacks of these layers in series and/or parallel. The fuel cell package materials such as a molded plastic or a ceramic green tape material can be patterned, aligned and stacked to form three dimensional microfluidic channels that provide electrical feedthroughs from various layers which are bonded together and mechanically support a MEMOS-based miniature fuel cell. The package incorporates resistive heating elements to control the temperature of the fuel cell stack. The package is fired to form a bond between the layers and one or more microporous flow host structures containing fuel cells are inserted within the Thick Film Microporous Flow Host Structure layer of the package.

Unsuccessfully Treated Hypertension: A Major Public Health Problem With a Potential Solution.

PubMed

Furberg, Curt D; Sealey, Jean E; Blumenfeld, Jon D

2017-09-01

About one-half of all hypertensive adults do not have their blood pressure controlled. They are often prescribed medications that conform to national guidelines but they continue to have elevated blood pressure. This public health problem might be improved by applying plasma renin guided therapy. A contributor to the public health problem of unsuccessfully treated hypertension is that the circulating renin-angiotensin system (RAS) is not recognized in treatment guidelines as clinically relevant for the treatment of hypertension or as important as the body salt status for determining blood pressure levels. Another contributor to the problem is the lack of specificity in the package inserts for antihypertensive drugs. They do not specifically state under the heading "Indications" that RAS blockers are primarily most effective in hypertensive subjects with medium and high plasma renin levels; by contrast, natriuretic drugs are most effective in those with low plasma renin levels. Literature review. To address the problem of unsuccessfully treated hypertension, we recommend that the "Indications" section of package inserts for antihypertensive drugs be more specific. The primary indication for RAS blockers ought to be hypertension with medium and high plasma renin levels, and natriuretic agents for those with low plasma renin levels. Similar language ought to be added to treatment guidelines. Additionally, 3 other reasons for lack of blood pressure control also need to be addressed-failure to prescribe antihypertensive drugs to hypertensive subjects, failure of patients to fill prescriptions, and low drug adherence. © American Journal of Hypertension, Ltd 2017. All rights reserved. For Permissions, please email: journals.permissions@oup.com

Postmarketing comparison of labetalol and propranolol in hypertensive patients.

PubMed

Due, D L; Giguere, G C; Plachetka, J R

1986-01-01

A survey was conducted to compare the safety and effectiveness of labetalol and propranolol under routine conditions of clinical use. Patients received either labetalol (n = 805) or propranolol (n = 135) twice daily, according to package insert instructions, for six weeks. Every two weeks the patients were evaluated and weight, heart rate, blood pressure, dose, and adverse symptoms were recorded. Both treatment groups experienced a significant decline in blood pressure at six weeks; blood pressure decreased by 24/15 mmHg in the labetalol patients and by 20/14 mmHg in the propranolol patients. Heart rate decreased significantly in both groups, but the drop in the propranolol group was greater than in the labetalol group. Significantly more propranolol-treated patients reported fatigue (15.2% versus 6.3%), impotence (9.0% versus 3.2%), bad dreams (2.3% versus 0.3%), and cold extremities (2.3% versus 0%). Dizziness was reported more frequently by the labetalol group (9.1% versus 3.8%). Overall, both drugs were safe and effective in treating hypertension, but complaints of beta-blocker-associated side effects were more frequent with propranolol.

Pharmacist, general practitioner and consumer use of written medicine information in Australia: are they on the same page?

PubMed

Hamrosi, Kim K; Raynor, David K; Aslani, Parisa

2014-01-01

Providing written medicine information to consumers enables them to make informed decisions about their medicines, playing an important role in educating and improving health literacy. In Australia, standardized written medicine information called Consumer Medicine Information (CMI) is available for medicines as package inserts, computer prints, or leaflets. Consumers want and read CMI, but may not always ask for it. General practitioners (GPs) and pharmacists are an important source of written medicine information, yet may not always provide CMI in their practice. To examine and compare the awareness, use and provision of CMI by consumers, pharmacists and general practitioners (GPs). Based on previous studies, structured questionnaires were developed and administered to a national sample of consumers (phone survey); community pharmacists and GPs (postal surveys) about utilization of CMI. Descriptive, comparative and logistic regression analyses were conducted. The respondents comprised of 349 pharmacists, 181 GPs and 1000 consumers. Two-thirds of consumers, nearly all (99%) pharmacists and 90% of GPs were aware of CMI. About 88% of consumers reported receiving CMI as a package insert, however most pharmacists (99%) and GPs (56%) reported providing computer-generated CMI. GPs' and pharmacists' main reason for providing CMI was on patient request. Reasons for not providing were predominantly because consumers were already taking the medicine, concerns regarding difficulty understanding the information, or potential non-adherence. Of the 691 consumers reportedly reading CMI, 35% indicated concerns after reading. Factors associated with reading included gender, type of CMI received and frequency of provision. Consumers want and read information about their medicines, especially when received from their GP or pharmacist. Healthcare professionals report usually discussing CMI when providing it to patients, although continued improvements in dissemination rates are desirable. Regular use of CMI remains a challenge, and ongoing strategies to promote CMI use are necessary to improve uptake of CMI in Australia. Copyright © 2014 Elsevier Inc. All rights reserved.

Body of Knowledge (BOK) for Leadless Quad Flat No-Lead/bottom Termination Components (QFN/BTC) Package Trends and Reliability

NASA Technical Reports Server (NTRS)

Ghaffarian, Reza

2014-01-01

Bottom terminated components and quad flat no-lead (BTC/QFN) packages have been extensively used by commercial industry for more than a decade. Cost and performance advantages and the closeness of the packages to the boards make them especially unique for radio frequency (RF) applications. A number of high-reliability parts are now available in this style of package configuration. This report presents a summary of literature surveyed and provides a body of knowledge (BOK) gathered on the status of BTC/QFN and their advanced versions of multi-row QFN (MRQFN) packaging technologies. The report provides a comprehensive review of packaging trends and specifications on design, assembly, and reliability. Emphasis is placed on assembly reliability and associated key design and process parameters because they show lower life than standard leaded package assembly under thermal cycling exposures. Inspection of hidden solder joints for assuring quality is challenging and is similar to ball grid arrays (BGAs). Understanding the key BTC/QFN technology trends, applications, processing parameters, workmanship defects, and reliability behavior is important when judicially selecting and narrowing the follow-on packages for evaluation and testing, as well as for the low risk insertion in high-reliability applications.

Antimicrobial, antioxidant and sensory features of eugenol, carvacrol and trans-anethole in active packaging for organic ready-to-eat iceberg lettuce.

PubMed

Wieczyńska, Justyna; Cavoski, Ivana

2018-09-01

In this study, bio-based emitting sachets containing eugenol (EUG), carvacrol (CAR) and trans-anethole (ANT) were inserted into cellulose (CE) and polypropylene (PP) pillow packages of organic ready-to-eat (RTE) iceberg lettuce to investigate their functional features. EUG, CAR and ANT sachets in CE; and CAR in PP packages showed antimicrobial activities against coliforms (Δlog CFU g -1 of -1.38, -0.91, -0.93 and -0.93, respectively). EUG and ANT sachets in both packages reduced discoloration (ΔE of 9.5, 1.8, 9.4 and 5.6, respectively). ANT in both, and EUG only in PP packages induced biosynthesis of caffeoyl derivatives (C a T A , D i C a T A , D i C a Q A ), total phenolics and antioxidant activity (FRAP). Also, ANT and EUG in both packages improved overall freshness and odor. Principal component analysis separated ANT and EUG from CAR in both packages. The Pearson correlation confirmed that overall quality improvements were more pronounced by ANT inside the packages in comparison to EUG and CAR. Copyright © 2018 Elsevier Ltd. All rights reserved.

Body of Knowledge (BOK) for Leadless Quad Flat No-Lead/Bottom Termination Components (QFN/BTC) Package Trends and Reliability

NASA Technical Reports Server (NTRS)

Ghaffarian, Reza

2014-01-01

Bottom terminated components and quad flat no-lead (BTC/QFN) packages have been extensively used by commercial industry for more than a decade. Cost and performance advantages and the closeness of the packages to the boards make them especially unique for radio frequency (RF) applications. A number of high-reliability parts are now available in this style of package configuration. This report presents a summary of literature surveyed and provides a body of knowledge (BOK) gathered on the status of BTC/QFN and their advanced versions of multi-row QFN (MRQFN) packaging technologies. The report provides a comprehensive review of packaging trends and specifications on design, assembly, and reliability. Emphasis is placed on assembly reliability and associated key design and process parameters because they show lower life than standard leaded package assembly under thermal cycling exposures. Inspection of hidden solder joints for assuring quality is challenging and is similar to ball grid arrays (BGAs). Understanding the key BTC/QFN technology trends, applications, processing parameters, workmanship defects, and reliability behavior is important when judicially selecting and narrowing the follow-on packages for evaluation and testing, as well as for the low risk insertion in high-reliability applications.

Patient counseling materials: The effect of patient health literacy on the comprehension of printed prescription drug information.

PubMed

Patel, Amit; Bakina, Daria; Kirk, Jim; von Lutcken, Scott; Donnelly, Tom; Stone, William; Ashley-Collins, Heather; Tibbals, Karen; Ricker, Lynn; Adler, Jeffrey; Ewing, John; Blechman, Michelle; Fox, Sherry; Leopold, Will; Ryan, Daniel; Wray, Donna; Turkoz, Heather

2018-05-16

Counseling patients with written materials relies equally on patients' health literacy to understand their disease and its treatment, and the written materials' effectiveness communicating clearly in accessible and actionable ways. Only about 12% of the US population is adequately health literate. To explore the impact of reducing the health literacy demands of written patient health information. 805 patients were screened for health literacy, and recruited for balanced cohorts of adequate and low literacy, and high and normal blood pressure. Half of each patient cohort received either standard or "health literacy-friendly" drug summaries (i.e. Patient Package Inserts, or PPIs or "leaflets") along with a standardized health literacy assessment scale. The literacy-friendly drug summary improved comprehension of drug-related information overall from 50% to 71% correct responses. Adequate literacy patients improved from 58% correct to 90%, while lower literacy patients improved from 42% to 52% correct in response to the health literacy-friendly PPIs. Health literacy demands require special attention in developing and using written drug summary materials. Additionally, pharmacists should be provided additional information and counseling support materials to facilitate communications with low health literacy level patients. Copyright © 2018 Elsevier Inc. All rights reserved.

Fuzzy based attitude controller for flexible spacecraft with on/off thrusters

NASA Astrophysics Data System (ADS)

Knapp, Roger G.; Adams, Neil J.

A fuzzy-based attitude controller is designed for attitude control of a generic spacecraft with on/off thrusters. The controller is comprised of packages of rules dedicated to addressing different objectives (e.g., disturbance rejection, low fuel consumption, avoiding the excitation of flexible appendages, etc.). These rule packages can be inserted or removed depending on the requirements of the particular spacecraft and are parameterized based on vehicle parameters such as inertia or operational parameters such as the maneuvering rate. Individual rule packages can be 'weighted' relative to each other to emphasize the importance of one objective relative to another. Finally, the fuzzy controller and rule packages are demonstrated using the high-fidelity Space Shuttle Interactive On-Orbit Simulator (IOS) while performing typical on-orbit operations and are subsequently compared with the existing shuttle flight control system performance.

Fuzzy based attitude controller for flexible spacecraft with on/off thrusters

NASA Astrophysics Data System (ADS)

Knapp, Roger Glenn

1993-05-01

A fuzzy-based attitude controller is designed for attitude control of a generic spacecraft with on/off thrusters. The controller is comprised of packages of rules dedicated to addressing different objectives (e.g., disturbance rejection, low fuel consumption, avoiding the excitation of flexible appendages, etc.). These rule packages can be inserted or removed depending on the requirements of the particular spacecraft and are parameterized based on vehicle parameters such as inertia or operational parameters such as the maneuvering rate. Individual rule packages can be 'weighted' relative to each other to emphasize the importance of one objective relative to another. Finally, the fuzzy controller and rule packages are demonstrated using the high-fidelity Space Shuttle Interactive On-Orbit Simulator (IOS) while performing typical on-orbit operations and are subsequently compared with the existing shuttle flight control system performance.

21 CFR 660.25 - Potency tests without reference preparations.

Code of Federal Regulations, 2012 CFR

2012-04-01

... manufacturer's package insert using red blood cells showing heterozygous or diminished expression of the... SERVICES (CONTINUED) BIOLOGICS ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Blood Grouping Reagent § 660.25 Potency tests without reference preparations. Products for which Reference Blood...

21 CFR 660.25 - Potency tests without reference preparations.

Code of Federal Regulations, 2010 CFR

2010-04-01

... manufacturer's package insert using red blood cells showing heterozygous or diminished expression of the... SERVICES (CONTINUED) BIOLOGICS ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Blood Grouping Reagent § 660.25 Potency tests without reference preparations. Products for which Reference Blood...

21 CFR 660.25 - Potency tests without reference preparations.

Code of Federal Regulations, 2014 CFR

2014-04-01

... manufacturer's package insert using red blood cells showing heterozygous or diminished expression of the... SERVICES (CONTINUED) BIOLOGICS ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Blood Grouping Reagent § 660.25 Potency tests without reference preparations. Products for which Reference Blood...

21 CFR 660.25 - Potency tests without reference preparations.

Code of Federal Regulations, 2011 CFR

2011-04-01

... manufacturer's package insert using red blood cells showing heterozygous or diminished expression of the... SERVICES (CONTINUED) BIOLOGICS ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Blood Grouping Reagent § 660.25 Potency tests without reference preparations. Products for which Reference Blood...

21 CFR 660.25 - Potency tests without reference preparations.

Code of Federal Regulations, 2013 CFR

2013-04-01

... manufacturer's package insert using red blood cells showing heterozygous or diminished expression of the... SERVICES (CONTINUED) BIOLOGICS ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Blood Grouping Reagent § 660.25 Potency tests without reference preparations. Products for which Reference Blood...

A Tale of Two Citizens: A State Attorney General and a Hematologist Facilitate Translation of Research Into US Food and Drug Administration Actions—A SONAR Report

PubMed Central

Chen, Brian; Restaino, John; Norris, LeAnn; Xirasagar, Sudha; Qureshi, Zaina P.; McKoy, June M.; Lopez, Isaac S.; Trenery, Alyssa; Murday, Alanna; Kahn, Adam; Mattison, Donald R.; Ray, Paul; Sartor, Oliver; Bennett, Charles L.

2012-01-01

Purpose: Pharmaceutical safety is a public health issue. In 2005, the Connecticut Attorney General (AG) raised concerns over adverse drug reactions in off-label settings, noting that thalidomide was approved to treat a rare illness, but more than 90% of its use was off label. A hematologist had reported thalidomide with doxorubicin or dexamethasone was associated with venous thromboembolism (VTE) rates of 25%. We review US Food and Drug Administration (FDA) and manufacturer responses to a citizen petition filed to address these thalidomide safety issues. Methods: Case study. Results: The AG petitioned the FDA requesting thalidomide-related safety actions. Coincidentally, the manufacturer submitted a supplemental New Drug Approval (sNDA), requesting approval to treat multiple myeloma with thalidomide-dexamethasone. FDA safety officers reviewed the petition and the literature and noted that VTE risks with thalidomide were not appropriately addressed in the existing package insert. In the sNDA application, the manufacturer reported thalidomide-associated toxicities for multiple myeloma were primarily somnolence and neurotoxicity, and a proposed package insert did not focus on VTE risks. In October, the FDA informed the Oncology Drug Division that VTE risks with thalidomide were poorly addressed in the existing label. After reviewing this memorandum, an Oncology Drug Division reviewer informed the manufacturer that approval of the sNDA would be delayed until several thalidomide-associated VTE safety actions, including revisions of the package insert, were implemented. The manufacturer and FDA agreed on these actions, and the sNDA was approved. Conclusion: New approaches addressing off-label safety are needed. The conditions that facilitated the successful response to this citizen petition are uncommon. PMID:23598851

A tale of two citizens: a State Attorney General and a hematologist facilitate translation of research into US Food and Drug Administration actions--a SONAR report.

PubMed

Chen, Brian; Restaino, John; Norris, LeAnn; Xirasagar, Sudha; Qureshi, Zaina P; McKoy, June M; Lopez, Isaac S; Trenery, Alyssa; Murday, Alanna; Kahn, Adam; Mattison, Donald R; Ray, Paul; Sartor, Oliver; Bennett, Charles L

2012-11-01

Pharmaceutical safety is a public health issue. In 2005, the Connecticut Attorney General (AG) raised concerns over adverse drug reactions in off-label settings, noting that thalidomide was approved to treat a rare illness, but more than 90% of its use was off label. A hematologist had reported thalidomide with doxorubicin or dexamethasone was associated with venous thromboembolism (VTE) rates of 25%. We review US Food and Drug Administration (FDA) and manufacturer responses to a citizen petition filed to address these thalidomide safety issues. Case study. The AG petitioned the FDA requesting thalidomide-related safety actions. Coincidentally, the manufacturer submitted a supplemental New Drug Approval (sNDA), requesting approval to treat multiple myeloma with thalidomide-dexamethasone. FDA safety officers reviewed the petition and the literature and noted that VTE risks with thalidomide were not appropriately addressed in the existing package insert. In the sNDA application, the manufacturer reported thalidomide-associated toxicities for multiple myeloma were primarily somnolence and neurotoxicity, and a proposed package insert did not focus on VTE risks. In October, the FDA informed the Oncology Drug Division that VTE risks with thalidomide were poorly addressed in the existing label. After reviewing this memorandum, an Oncology Drug Division reviewer informed the manufacturer that approval of the sNDA would be delayed until several thalidomide-associated VTE safety actions, including revisions of the package insert, were implemented. The manufacturer and FDA agreed on these actions, and the sNDA was approved. New approaches addressing off-label safety are needed. The conditions that facilitated the successful response to this citizen petition are uncommon.

A Web-based searchable system to confirm magnetic resonance compatibility of implantable medical devices in Japan: a preliminary study.

PubMed

Fujiwara, Yasuhiro; Fujioka, Hitoshi; Watanabe, Tomoko; Sekiguchi, Maiko; Murakami, Ryuji

2017-09-01

Confirmation of the magnetic resonance (MR) compatibility of implanted medical devices (IMDs) is mandatory before conducting magnetic resonance imaging (MRI) examinations. In Japan, few such confirmation methods are in use, and they are time-consuming. This study aimed to develop a Web-based searchable MR safety information system to confirm IMD compatibility and to evaluate the usefulness of the system. First, MR safety information for intravascular stents and stent grafts sold in Japan was gathered by interviewing 20 manufacturers. These IMDs were categorized based on the descriptions available on medical package inserts as: "MR Safe," "MR Conditional," "MR Unsafe," "Unknown," and "No Medical Package Insert Available". An MR safety information database for implants was created based on previously proposed item lists. Finally, a Web-based searchable system was developed using this database. A questionnaire was given to health-care personnel in Japan to evaluate the usefulness of this system. Seventy-nine datasets were collected using information provided by 12 manufacturers and by investigating the medical packaging of the IMDs. Although the datasets must be updated by collecting data from other manufacturers, this system facilitates the easy and rapid acquisition of MR safety information for IMDs, thereby improving the safety of MRI examinations.

Women's preferences for vaginal antimicrobial contraceptives. III. Choice of a formulation, applicator, and packaging.

PubMed

Hardy, E; Jiménez, A L; de Pádua, K S; Zaneveld, L J

1998-10-01

Novel vaginal formulations are under development to combat the increasing incidence of sexually transmitted diseases, including AIDS, and also unplanned pregnancies. A study was performed to determine women's preferences for different dosage forms (gel, cream, ovule/suppository, film, foam, tablet), width, length, and color of an applicator, and various types of packages. The study was conducted in Campinas, Brazil. A total of 635 women were interviewed, including both adolescents and adults and low and middle-high socioeconomic groups. The large majority of the women preferred a gel over a cream; both were preferred over the other methods. When asked which method they would not use, the film was most frequently identified, followed by the tablet and ovule. The primary reasons for selecting a particular dosage form were ease of use, absence of odor or the presence of a pleasant one, absence of color, and insertion with an applicator. The major reasons for not using a method were discomfort, "plastic" appearance, distrust of effectiveness, difficulty with insertion, messiness, and rigidity/hardness. The majority of the women liked the applicator shown. The prefilled single dose applicator was by far the preferred packaging. This information should aid in the development of consumer-friendly, vaginal formulations.

Treatment and disease management of multiple sclerosis patients: A review for nurse practitioners.

PubMed

Roman, Cortnee; Menning, Kara

2017-10-01

This review discusses the role of the nurse practitioner (NP) in evaluating the clinical effects, potential side effects, and monitoring requirements for treatment options in multiple sclerosis (MS) and provides guidance on how to help patients understand these issues. A literature search was conducted on PubMed to identify publications on monitoring and disease management of MS patients. Additional resources included drug information web sites and package inserts. NPs play an active role in the management of MS patients via effective monitoring and communication throughout the patient's treatment regimen and disease course. In the shared decision-making model of MS treatment, NPs ensure that patients understand the implications of their disease-modifying therapies (DMTs). As patients move through treatments during the course of their disease, the importance of this role increases, and it is critical that NPs follow the guidelines in each medication's product label and take into account any potential lingering effects of prior medications. It is critical for NPs to promote patient adherence, to ensure that patients understand treatment side effects and monitoring requirements, and to take sequencing and reversibility implications of DMTs into account when making clinical decisions. ©2017 American Association of Nurse Practitioners.

Evaluating the patient experience after implantation of a 0.4 mg sustained release dexamethasone intracanalicular insert (Dextenza™): results of a qualitative survey.

PubMed

Gira, Joseph P; Sampson, Reginald; Silverstein, Steven M; Walters, Thomas R; Metzinger, Jamie Lynne; Talamo, Jonathan H

2017-01-01

The purpose of this study is to evaluate the patient experience of sustained release dexamethasone intracanalicular insert (Dextenza™) following cataract surgery as part of a Phase III clinical trial program. This cross-sectional, qualitative evaluation involved individual interviews lasting approximately 45 minutes. Patients from four US investigational study sites who had previously received an insert were enrolled. There were no predesignated end points; this was a qualitative survey seeking a deeper understanding of patient experience. Twenty-five patients were interviewed. Most patients (92%) reported the highest level of satisfaction grade with regard to overall product satisfaction. All patients described the insert as comfortable. Most patients (96%) described their overall experience with the insert as very convenient or extremely convenient. Twenty-two of 23 (96%) participants rated their experience with the insert as "very" or "extremely convenient", compared to previous topical therapy, and 88% of patients stated that if they were to undergo cataract surgery again, they would request the insert. When asked if they would recommend the insert to family members or friends, 92% stated they would. The survey found that 84% of participants would be willing to pay more for the insert than for eye drop therapy. The dexamethasone insert was found by patients to be highly favorable with regard to overall satisfaction, convenience, and comfort. The insert was well received and largely preferred over topical therapy alternatives following surgery. More extensive evaluation of the patient experience is warranted, and future studies should help inform design of the next generation of sustained release drug delivery systems.

Integrated Electrode Arrays for Neuro-Prosthetic Implants

NASA Technical Reports Server (NTRS)

Brandon, Erik; Mojarradi, Mohammede

2003-01-01

Arrays of electrodes integrated with chip-scale packages and silicon-based integrated circuits have been proposed for use as medical electronic implants, including neuro-prosthetic devices that might be implanted in brains of patients who suffer from strokes, spinal-cord injuries, or amyotrophic lateral sclerosis. The electrodes of such a device would pick up signals from neurons in the cerebral cortex, and the integrated circuit would perform acquisition and preprocessing of signal data. The output of the integrated circuit could be used to generate, for example, commands for a robotic arm. Electrode arrays capable of acquiring electrical signals from neurons already exist, but heretofore, there has been no convenient means to integrate these arrays with integrated-circuit chips. Such integration is needed in order to eliminate the need for the extensive cabling now used to pass neural signals to data-acquisition and -processing equipment outside the body. The proposed integration would enable progress toward neuro-prostheses that would be less restrictive of patients mobility. An array of electrodes would comprise a set of thin wires of suitable length and composition protruding from and supported by a fine-pitch micro-ball grid array or chip-scale package (see figure). The associated integrated circuit would be mounted on the package face opposite the probe face, using the solder bumps (the balls of the ball grid array) to make the electrical connections between the probes and the input terminals of the integrated circuit. The key innovation is the insertion of probe wires of the appropriate length and material into the solder bumps through a reflow process, thereby fixing the probes in place and electrically connecting them with the integrated circuit. The probes could be tailored to any distribution of lengths and made of any suitable metal that could be drawn into fine wires. Furthermore, the wires could be coated with an insulating layer using anodization or other processes, to achieve the correct electrical impedance. The probe wires and the packaging materials must be biocompatible using such materials as lead-free solders. For protection, the chip and package can be coated with parylene.

"Doctor, are you trying to kill me?": ambivalence about the patient package insert for estrogen.

PubMed

Watkins, Elizabeth Siegel

2002-01-01

In 1976, the U.S. Food and Drug Administration proposed new requirements for patient labeling for estrogens prescribed for menopausal and postmenopausal women. This paper explores the variety of responses to this proposal from women and their husbands, feminist and consumer activists, physicians, pharmacists, and pharmaceutical manufacturers, as represented in letters written to the FDA. The drug industry and the medical profession opposed patient labeling on the grounds of cost and a resentment of governmental intrusion. Feminists and consumer advocates were in favor of the idea, but the response from current estrogen users was mixed: most women wished to be better informed, but many expressed concern that estrogen would be removed from the market. This ambivalence suggests unresolved tensions regarding conceptions of female aging, the medical management of menopause and aging, informed consent in medicine, and governmental regulation of medical practice. The debate thus represents an important moment in the history of women's health care.

Device-packaging method and apparatus for optoelectronic circuits

DOEpatents

Zortman, William A.; Henry, Michael David; Jarecki, Jr., Robert L.

2017-04-25

An optoelectronic device package and a method for its fabrication are provided. The device package includes a lid die and an active die that is sealed or sealable to the lid die and in which one or more optical waveguides are integrally defined. The active die includes one or more active device regions, i.e. integral optoelectronic devices or etched cavities for placement of discrete optoelectronic devices. Optical waveguides terminate at active device regions so that they can be coupled to them. Slots are defined in peripheral parts of the active dies. At least some of the slots are aligned with the ends of integral optical waveguides so that optical fibers or optoelectronic devices inserted in the slots can optically couple to the waveguides.

Fuzzy based attitude controller for flexible spacecraft with on/off thrusters. M.S. Thesis - M.I.T., 1993

NASA Technical Reports Server (NTRS)

Knapp, Roger Glenn

1993-01-01

A fuzzy-based attitude controller is designed for attitude control of a generic spacecraft with on/off thrusters. The controller is comprised of packages of rules dedicated to addressing different objectives (e.g., disturbance rejection, low fuel consumption, avoiding the excitation of flexible appendages, etc.). These rule packages can be inserted or removed depending on the requirements of the particular spacecraft and are parameterized based on vehicle parameters such as inertia or operational parameters such as the maneuvering rate. Individual rule packages can be 'weighted' relative to each other to emphasize the importance of one objective relative to another. Finally, the fuzzy controller and rule packages are demonstrated using the high-fidelity Space Shuttle Interactive On-Orbit Simulator (IOS) while performing typical on-orbit operations and are subsequently compared with the existing shuttle flight control system performance.

Evaluating the patient experience after implantation of a 0.4 mg sustained release dexamethasone intracanalicular insert (Dextenza™): results of a qualitative survey

PubMed Central

Gira, Joseph P; Sampson, Reginald; Silverstein, Steven M; Walters, Thomas R; Metzinger, Jamie Lynne; Talamo, Jonathan H

2017-01-01

Purpose The purpose of this study is to evaluate the patient experience of sustained release dexamethasone intracanalicular insert (Dextenza™) following cataract surgery as part of a Phase III clinical trial program. Methods This cross-sectional, qualitative evaluation involved individual interviews lasting approximately 45 minutes. Patients from four US investigational study sites who had previously received an insert were enrolled. There were no predesignated end points; this was a qualitative survey seeking a deeper understanding of patient experience. Results Twenty-five patients were interviewed. Most patients (92%) reported the highest level of satisfaction grade with regard to overall product satisfaction. All patients described the insert as comfortable. Most patients (96%) described their overall experience with the insert as very convenient or extremely convenient. Twenty-two of 23 (96%) participants rated their experience with the insert as “very” or “extremely convenient”, compared to previous topical therapy, and 88% of patients stated that if they were to undergo cataract surgery again, they would request the insert. When asked if they would recommend the insert to family members or friends, 92% stated they would. The survey found that 84% of participants would be willing to pay more for the insert than for eye drop therapy. Conclusion The dexamethasone insert was found by patients to be highly favorable with regard to overall satisfaction, convenience, and comfort. The insert was well received and largely preferred over topical therapy alternatives following surgery. More extensive evaluation of the patient experience is warranted, and future studies should help inform design of the next generation of sustained release drug delivery systems. PMID:28331295

Evaluation of diminished microbial contamination in handling of a novel daily disposable flat pack contact lens.

PubMed

Nomachi, Miya; Sakanishi, Kotaro; Ichijima, Hideji; Cavanagh, H Dwight

2013-05-01

To evaluate the efficacy of a novel daily disposable (DD) flat package in regard to microbial contamination on the anterior and posterior surfaces of a contact lens (CL) during handling of the lens for insertion. Four kinds of commercially available general blister-packed daily disposable contact lenses (DD CLs) as controls and a novel Magic 1-day Menicon Flat Pack as a test lens were used for this in vitro study. Lenses were removed from their packages using fingers coated with fluorescein 3 to 5 μm beads or an approximately 7×10(2) to 2×10(3) colony-forming unit (CFU)/mL Staphylococcus aureus suspension. The transfer of fluorescein beads to the surface of the lenses was then observed by fluorescence microscopy. Microbial contamination on the lenses was observed by light microscopy after a 2-day incubation period; and, the number of colonies isolated from the contaminated lenses was determined after 4 days of incubation. The number of fluorescein beads on the Magic lens was significantly less (p<0.05) than that of the general blister-packed control lenses. Adherence of microbial colonies was observed on both inner and outer surfaces of general blister-packed lenses, whereas no colony formation was found on the inner surface of the Magic lens, and the lowest bacterial adherence was observed for the Magic lens. The data demonstrated that placement of the Magic DD lens onto the eye is accompanied by diminished microbial contamination compared with general blister-packed DD CLs. Eye care professionals; however, should instruct patients to comply with intended use of DD CLs to prevent CL-associated microbial keratitis. In all cases, hand washing is mandated prelens insertion.

Intracellular Distribution of Capsid-Associated pUL77 of Human Cytomegalovirus and Interactions with Packaging Proteins and pUL93.

PubMed

Köppen-Rung, Pánja; Dittmer, Alexandra; Bogner, Elke

2016-07-01

DNA packaging into procapsids is a common multistep process during viral maturation in herpesviruses. In human cytomegalovirus (HCMV), the proteins involved in this process are terminase subunits pUL56 and pUL89, which are responsible for site-specific cleavage and insertion of the DNA into the procapsid via portal protein pUL104. However, additional viral proteins are required for the DNA packaging process. We have shown previously that the plasmid that encodes capsid-associated pUL77 encodes another potential player during capsid maturation. Pulse-chase experiments revealed that pUL77 is stably expressed during HCMV infection. Time course analysis demonstrated that pUL77 is expressed in the early late part of the infectious cycle. The sequence of pUL77 was analyzed to find nuclear localization sequences (NLSs), revealing monopartite NLSm at the N terminus and bipartite NLSb in the middle of pUL77. The potential NLSs were inserted into plasmid pHM829, which encodes a chimeric protein with β-galactosidase and green fluorescent protein. In contrast to pUL56, neither NLSm nor NLSb was sufficient for nuclear import. Furthermore, we investigated by coimmunoprecipitation whether packaging proteins, as well as pUL93, the homologue protein of herpes simplex virus 1 pUL17, are interaction partners of pUL77. The interactions between pUL77 and packaging proteins, as well as pUL93, were verified. We showed that the capsid-associated pUL77 is another potential player during capsid maturation of HCMV. Protein UL77 (pUL77) is a conserved core protein of HCMV. This study demonstrates for the first time that pUL77 has early-late expression kinetics during the infectious cycle and an intrinsic potential for nuclear translocation. According to its proposed functions in stabilization of the capsid and anchoring of the encapsidated DNA during packaging, interaction with further DNA packaging proteins is required. We identified physical interactions with terminase subunits pUL56 and pUL89 and another postulated packaging protein, pUL93, in infected, as well as transfected, cells. Copyright © 2016, American Society for Microbiology. All Rights Reserved.

22 CFR 125.6 - Certification requirements for exemptions.

Code of Federal Regulations, 2010 CFR

2010-04-01

... LICENSES FOR THE EXPORT OF TECHNICAL DATA AND CLASSIFIED DEFENSE ARTICLES § 125.6 Certification requirements for exemptions. (a) To claim an exemption for the export of technical data under the provisions of.... Certifications consist of clearly marking the package or letter containing the technical data “22 CFR [insert...

22 CFR 125.6 - Certification requirements for exemptions.

Code of Federal Regulations, 2011 CFR

2011-04-01

.... Certifications consist of clearly marking the package or letter containing the technical data “22 CFR [insert... LICENSES FOR THE EXPORT OF TECHNICAL DATA AND CLASSIFIED DEFENSE ARTICLES § 125.6 Certification requirements for exemptions. (a) To claim an exemption for the export of technical data under the provisions of...

22 CFR 125.6 - Certification requirements for exemptions.

Code of Federal Regulations, 2013 CFR

2013-04-01

.... Certifications consist of clearly marking the package or letter containing the technical data “22 CFR [insert... LICENSES FOR THE EXPORT OF TECHNICAL DATA AND CLASSIFIED DEFENSE ARTICLES § 125.6 Certification requirements for exemptions. (a) To claim an exemption for the export of technical data under the provisions of...

22 CFR 125.6 - Certification requirements for exemptions.

Code of Federal Regulations, 2014 CFR

2014-04-01

.... Certifications consist of clearly marking the package or letter containing the technical data “22 CFR [insert... LICENSES FOR THE EXPORT OF TECHNICAL DATA AND CLASSIFIED DEFENSE ARTICLES § 125.6 Certification requirements for exemptions. (a) To claim an exemption for the export of technical data under the provisions of...

22 CFR 125.6 - Certification requirements for exemptions.

Code of Federal Regulations, 2012 CFR

2012-04-01

.... Certifications consist of clearly marking the package or letter containing the technical data “22 CFR [insert... LICENSES FOR THE EXPORT OF TECHNICAL DATA AND CLASSIFIED DEFENSE ARTICLES § 125.6 Certification requirements for exemptions. (a) To claim an exemption for the export of technical data under the provisions of...

An Assessment of the Influence of the Industry Distribution Chain on the Oxygen Levels in Commercial Modified Atmosphere Packaged Cheddar Cheese Using Non-Destructive Oxygen Sensor Technology.

PubMed

O' Callaghan, Karen A M; Papkovsky, Dmitri B; Kerry, Joseph P

2016-06-20

The establishment and control of oxygen levels in packs of oxygen-sensitive food products such as cheese is imperative in order to maintain product quality over a determined shelf life. Oxygen sensors quantify oxygen concentrations within packaging using a reversible optical measurement process, and this non-destructive nature ensures the entire supply chain can be monitored and can assist in pinpointing negative issues pertaining to product packaging. This study was carried out in a commercial cheese packaging plant and involved the insertion of 768 sensors into 384 flow-wrapped cheese packs (two sensors per pack) that were flushed with 100% carbon dioxide prior to sealing. The cheese blocks were randomly assigned to two different storage groups to assess the effects of package quality, packaging process efficiency, and handling and distribution on package containment. Results demonstrated that oxygen levels increased in both experimental groups examined over the 30-day assessment period. The group subjected to a simulated industrial distribution route and handling procedures of commercial retailed cheese exhibited the highest level of oxygen detected on every day examined and experienced the highest rate of package failure. The study concluded that fluctuating storage conditions, product movement associated with distribution activities, and the possible presence of cheese-derived contaminants such as calcium lactate crystals were chief contributors to package failure.

An Assessment of the Influence of the Industry Distribution Chain on the Oxygen Levels in Commercial Modified Atmosphere Packaged Cheddar Cheese Using Non-Destructive Oxygen Sensor Technology

PubMed Central

O’ Callaghan, Karen A.M.; Papkovsky, Dmitri B.; Kerry, Joseph P.

2016-01-01

The establishment and control of oxygen levels in packs of oxygen-sensitive food products such as cheese is imperative in order to maintain product quality over a determined shelf life. Oxygen sensors quantify oxygen concentrations within packaging using a reversible optical measurement process, and this non-destructive nature ensures the entire supply chain can be monitored and can assist in pinpointing negative issues pertaining to product packaging. This study was carried out in a commercial cheese packaging plant and involved the insertion of 768 sensors into 384 flow-wrapped cheese packs (two sensors per pack) that were flushed with 100% carbon dioxide prior to sealing. The cheese blocks were randomly assigned to two different storage groups to assess the effects of package quality, packaging process efficiency, and handling and distribution on package containment. Results demonstrated that oxygen levels increased in both experimental groups examined over the 30-day assessment period. The group subjected to a simulated industrial distribution route and handling procedures of commercial retailed cheese exhibited the highest level of oxygen detected on every day examined and experienced the highest rate of package failure. The study concluded that fluctuating storage conditions, product movement associated with distribution activities, and the possible presence of cheese-derived contaminants such as calcium lactate crystals were chief contributors to package failure. PMID:27331815

Peripheral Intravenous Catheterisation in Obstetric Patients in the Hand or Forearm Vein: A Randomised Trial

PubMed Central

Tan, Peng Chiong; Mackeen, Anjana; Khong, Su Yen; Omar, Siti Zawiah; Azmi, M. A. Noor

2016-01-01

A peripheral intravenous catheter is often inserted as part of care during labour. The catheter is inserted into the back of the hand or lower forearm vein in usual practice. There is no trial data to guide the care provider on which is the better insertion site in any clinical setting. 307 women admitted to the labour ward who required insertion of intravenous catheter were randomised to back of hand or lower forearm vein catheter insertion. Catheter insertion is by junior to mid-grade providers. We evaluated insertion success at the first attempt, pain during insertion and catheter replacement due to malfunction as main outcomes. After catheter removal, we recorded patient satisfaction with site, future site preference and insertion site swelling, bruising, tenderness, vein thrombosis and pain. Insertion of a catheter into back of hand vein is more likely to be successful at the first attempt. Insertion pain score, catheter replacement rate, patient satisfaction, patient fidelity to site in a future insertion and insertion site complications rate are not different between trial arms. In conclusion, both insertion sites are suitable; the back of the hand vein maybe easier to cannulate and seems to be preferred by our frontline providers. PMID:26987593

High-Tc superconductor coplanar waveguide filter

NASA Technical Reports Server (NTRS)

Chew, Wilbert; Bajuk, Louis J.; Cooley, Thomas W.; Foote, Marc C.; Hunt, Brian D.; Rascoe, Daniel L.; Riley, A. L.

1991-01-01

Coplanar waveguide (CPW) low-pass filters made of YBa2Cu3O(7-delta) (YBCO) on LaAlO3 substrates, with dimensions suited for integrated circuits, were fabricated and packaged. A complete filter gives a true idea of the advantages and difficulties in replacing thin-film metal with a high-temperature superconductor in a practical circuit. Measured insertion losses in liquid nitrogen were superior to the loss of a similar thin-film copper filter throughout the 0- to 9.5-GHz passband. These results demonstrate the performance of fully patterned YBCO in a practical CPW structure after sealing in a hermetic package.

Apparatus and Method for Packaging and Integrating Microphotonic Devices

NASA Technical Reports Server (NTRS)

Nguyen, Hung (Inventor)

2008-01-01

An apparatus is disclosed that includes a carrier structure and an optical coupling arrangement. The carrier structure is made of a silicon material and allows for the packaging and integrating of microphotonic devices onto a single chip. The optical coupling mechanism enables laser light to be coupled into and out of a microphotonic resonant disk integrated on the carrier. The carrier provides first, second and third cavities that are dimensioned so as to accommodate the insertion and snug fitting of the microphotonic resonant disk and first and second prisms that are implemented by the optical coupling arrangement to accommodate the laser coupling.

Agony of the ecstasy: report of five cases of MDMA smuggling.

PubMed

Low, V H S; Dillon, E K

2005-10-01

The international smuggling of illicit drugs by the ingestion or rectal insertion of drug-filled packages is recognized in the trafficking of heroin and cocaine. Customs authorities, with suspicion of such activities, presented five subjects. The legally allowed radiological examination comprising one supine abdominal radiograph was performed. Radiographic findings demonstrated the presence of multiple enteric oval, capsule-shaped packages of soft tissue density. This was confirmed following supervised evacuation of bowel contents induced by the administration of laxatives. Analysis of the concealed material identified ecstasy (methylenedioxymethamphetamine (MDMA)), a substance not previously reported as transported by this route.

Shoe inserts alter plantar loading and function in patients with midfoot arthritis.

PubMed

Rao, Smita; Baumhauer, Judith F; Becica, Laura; Nawoczenski, Deborah A

2009-07-01

Experimental laboratory study supplemented by a case series. (1) To assess the effect of a 4-week intervention with a full-length insert on functional outcomes in patients with midfoot arthritis; (2) to examine the effect of the custom molded three-quarter-length (3Q) and full-length (FL) carbon graphite insert on plantar loading in patients with midfoot arthritis. Given the coexistence of pain and lower-arched foot alignment in patients with midfoot arthritis, arch-restoring orthotic devices such as the 3Q insert are frequently recommended. However, patients continue to report foot pain despite using the 3Q insert. The FL insert has been proposed as an alternative, but objective data examining its efficacy are lacking. Twenty female patients with midfoot arthritis participated in the study. Functional outcomes were assessed using the Foot Function Index-Revised (FFI-R). Plantar loading during walking was measured in the following conditions: shoe only, shoe with 3Q insert, and shoe with FL insert. Repeated-measures analyses of variance with post hoc analyses were used for statistical analysis. FL insert use for 4 weeks resulted in a 12% improvement in total FFI-R score (mean +/- SD before, 35.6 +/- 10.9; after, 31.1 +/- 9.8 [P = .03]). FL insert use resulted in a 20% reduction in medial midfoot average pressure loading (mean +/- SD, 64.8 +/- 20.4 and 51.0 +/- 15.4 kPa, with 3Q and FL insert respectively [P = .015]) and an 8.5% reduction in medial midfoot contact time (mean +/- SD, 84.9% +/- 6.4% and 76.4% +/- 7.1% of stance, with 3Q and FL insert respectively [P<.01]), compared to the 3Q insert. No differences in plantar loading were discerned between the shoe-only and FL conditions. Symptomatic improvement in patients with midfoot arthritis treated with a FL insert was accompanied by reduced magnitude and duration of loading under the medial midfoot. These preliminary outcomes suggest that the FL insert may be a viable alternative in the conservative management of patients with midfoot arthritis. Therapy, level 4. J Orthop Sports Phys Ther 2009;39(7):522-531. doi:10.2519/jospt.2009.2900.

[Sniffing Position and i-gel Rotation Approach for i-gel Insertion under General Anesthesia].

PubMed

Takahashi, Yoshihiro; Murashima, Koji; Kayashima, Kenji

2016-04-01

Insertion assistance techniques, such as the sniffing position (SP) and i-gel? rotation approach (RA), are recommended in the i-gel supraglottic airway device insertion manual. The usefulness of these techniques was evaluated, in this study, under general anesthesia. In 50 adult patients, the i-gel was inserted with the patient in the mild-SP with 5 degrees head extention at first attempt. When resistance was encountered during insertion or airway patency was not obtained after insertion, the i-gel was re-inserted with the patient in the full-SP with maximum head extention during second attempt. When re-insertion failed, the i-gel was inserted with the patient in the full-SP and by using the i-gel RA during third attempt. Airway patency was established in the mild-SP in 36 of 50 patients, in the full-SP in 11 of the remaining 14, and in the full-SP with the i-gel RA in the remaining 3. The average insertion time was 24.0 s during the first attempt, 22.2 s during the second, and 18.2 s during the third. No major complications were observed. Both the full-SP and the i-gel RA can be used for i-gel insertion.

Radiological Tenckhoff catheter insertion for peritoneal dialysis: A cost-effective approach.

PubMed

Lee, James; Mott, Nigel; Mahmood, Usman; Clouston, John; Summers, Kara; Nicholas, Pauline; Gois, Pedro Henrique França; Ranganathan, Dwarakanathan

2018-04-01

Radiological insertion of Tenckhoff catheters can be an alternative option for peritoneal dialysis access creation, as compared to surgical catheter insertion. This study will review the outcomes and complications of radiological Tenckhoff catheter insertion in a metropolitan renal service and compare costs between surgical and radiological insertion. Data were collected prospectively for all patients who had a Tenckhoff catheter insertion for peritoneal dialysis (PD) under radiological guidance at our hospital from May 2014 to November 2016. The type of catheter used and complications, including peri-catheter leak, exit site infection and peritonitis were reviewed. Follow-up data were also collected at points 3, 6 and 12 months from catheter insertion. Costing data were obtained from Queensland Health Electronic Reporting System (QHERS) data, average staff salaries and consumable contract price lists. In the 30-month evaluation period, 70 catheters were inserted. Two patients had an unsuccessful procedure due to the presence of abdominal adhesions. Seven patients had an episode of peri-catheter leak, and four patients had an exit site infection following catheter insertion. Peritonitis was observed in nine patients during the study period. The majority of patients (90%) remained on peritoneal dialysis at 3-month follow-up. The average costs of surgical and radiological insertion were noted to be AUD$7788.34 and AUD$1597.35, respectively. Radiological Tenckhoff catheter insertion for peritoneal dialysis appears to be an attractive and cost-effective option given less waiting periods for the procedure, the relatively low cost of insertion and comparable rates of complications. © 2017 The Royal Australian and New Zealand College of Radiologists.

Pain and distress induced by elastomeric and spring separators in patients undergoing orthodontic treatment.

PubMed

Al-Balbeesi, Hana O; Bin Huraib, Sahar M; AlNahas, Nadia W; AlKawari, Huda M; Abu-Amara, Abdulrahman B; Vellappally, Sajith; Anil, Sukumaran

2016-01-01

The objective of the present investigation is to evaluate patients' pain perception and discomfort, the duration of pain and the level of self-medication over time during tooth separation, and the effectiveness of elastomeric and spring types of orthodontic separators in Saudi population. The study group consisted of 30 female adolescent patients who had elastomeric/spring separators as part of their orthodontic treatment. A self-administrated questionnaire comprising 16 multiple choice questions and another with visual analog scale were used to record the patient's pain perceptions at 4 hours, 24 hours, 3 days, 5 days, and 7 days from the time of insertion. The level of pain and discomfort during these time periods were assessed by a visual analog scale. After a separation period of 7 days, the amount of separation was measured with a leaf gauge. Type and frequency of analgesic consumption was also recorded. The Statistical Package for the Social Sciences (SPSS) version 20 (IBM SPSS -Chicago, IL: SPSS Inc.,) was used for statistical analysis. The data showed significant increase in the level of pain at 4 hours, 24 hours, and 3 days from separator placement. The elastomeric separators produced significantly more separation than the spring separators and also caused maximum pain during the first 3 days after insertion. However, there was no significant difference between the score of pain between two separators at all time intervals. Both elastomeric and spring separators showed comparative levels of pain and discomfort during the early phase of separation. Elastomeric separators were found to be more effective in tooth separation than spring separators. However, further studies are necessary to substantiate this preliminary observation.

21 CFR 357.152 - Package inserts for anthelmintic drug products.

Code of Federal Regulations, 2013 CFR

2013-04-01

... discussion of the symptoms suggestive of pinworm infestation, including a statement that pinworms must be... the pinworm. (c) A commentary on the life cycle of the pinworm. (d) A commentary on the ways in which pinworms may be spread from person to person and hygienic procedures to follow to avoid such spreading. (e...

21 CFR 357.152 - Package inserts for anthelmintic drug products.

Code of Federal Regulations, 2010 CFR

2010-04-01

... discussion of the symptoms suggestive of pinworm infestation, including a statement that pinworms must be... the pinworm. (c) A commentary on the life cycle of the pinworm. (d) A commentary on the ways in which pinworms may be spread from person to person and hygienic procedures to follow to avoid such spreading. (e...

21 CFR 357.152 - Package inserts for anthelmintic drug products.

Code of Federal Regulations, 2011 CFR

2011-04-01

... discussion of the symptoms suggestive of pinworm infestation, including a statement that pinworms must be... the pinworm. (c) A commentary on the life cycle of the pinworm. (d) A commentary on the ways in which pinworms may be spread from person to person and hygienic procedures to follow to avoid such spreading. (e...

21 CFR 357.152 - Package inserts for anthelmintic drug products.

Code of Federal Regulations, 2012 CFR

2012-04-01

... discussion of the symptoms suggestive of pinworm infestation, including a statement that pinworms must be... the pinworm. (c) A commentary on the life cycle of the pinworm. (d) A commentary on the ways in which pinworms may be spread from person to person and hygienic procedures to follow to avoid such spreading. (e...

21 CFR 357.152 - Package inserts for anthelmintic drug products.

Code of Federal Regulations, 2014 CFR

2014-04-01

... discussion of the symptoms suggestive of pinworm infestation, including a statement that pinworms must be... the pinworm. (c) A commentary on the life cycle of the pinworm. (d) A commentary on the ways in which pinworms may be spread from person to person and hygienic procedures to follow to avoid such spreading. (e...

Isolating USB connections in medical equipment.

PubMed

Broeders, Jan-Hein

2009-01-01

Although offering several benefits, the universal serial bus (USB) port has not been rapidly adopted for connecting medical equipment. This is because it could affect safety procedures, with equipment not operating isolated from the mains. To overcome this, a single package isolation device has been developed that can be inserted directly into the USB signal path.

Standard Hardware Acquisition and Reliability Program's (SHARP's) efforts in incorporating fiber optic interconnects into standard electronic module (SEM) connectors

NASA Astrophysics Data System (ADS)

Riggs, William R.

1994-05-01

SHARP is a Navy wide logistics technology development effort aimed at reducing the acquisition costs, support costs, and risks of military electronic weapon systems while increasing the performance capability, reliability, maintainability, and readiness of these systems. Lower life cycle costs for electronic hardware are achieved through technology transition, standardization, and reliability enhancement to improve system affordability and availability as well as enhancing fleet modernization. Advanced technology is transferred into the fleet through hardware specifications for weapon system building blocks of standard electronic modules, standard power systems, and standard electronic systems. The product lines are all defined with respect to their size, weight, I/O, environmental performance, and operational performance. This method of defining the standard is very conducive to inserting new technologies into systems using the standard hardware. This is the approach taken thus far in inserting photonic technologies into SHARP hardware. All of the efforts have been related to module packaging; i.e. interconnects, component packaging, and module developments. Fiber optic interconnects are discussed in this paper.

[Safety profile of heterologous serum produced by the Butantan Institute, in São Paulo-SP, Brazil, from 2012 to 2015].

PubMed

Gattás, Vera Lúcia; Braga, Patrícia Emília; Koike, Marcelo Eiji; Lucchesi, Maria Beatriz; Precioso, Alexander Roberto

2017-01-01

to describe the safety profile of the heterologous serum produced by the Butantan Institute (BI) of São Paulo-SP, Brazil. a descriptive study of adverse events (AEs) post-exposure to serum produced by the BI, encoded in the medical terminology of the Medical Dictionary for Regulatory Activities (MedDRA), and spontaneously reported to BI from 2012 to 2015. 52 individuals reported AEs, mainly related to Bothrops antivenom (n=11), diphtheria antitoxin (n=9) and unspecified snakebite serum (n=9); a mean of 3.2 AEs per individual was observed; among the total of 173 AEs, 63.0% were expected considering that they were described in the package insert; most of them were classified as skin and subcutaneous tissue disorders (30.6%); there were six deaths temporally related to the use of serum, but this association was discarded. in the studied period, the serum produced by the BI had no changes in their safety profiles, considering that the AEs were expected, according to the information previously described in the package insert.

Patterns of Care for Biologic-Dosing Outliers and Nonoutliers in Biologic-Naive Patients with Rheumatoid Arthritis.

PubMed

Delate, Thomas; Meyer, Roxanne; Jenkins, Daniel

2017-08-01

Although most biologic medications for patients with rheumatoid arthritis (RA) have recommended fixed dosing, actual biologic dosing may vary among real-world patients, since some patients can receive higher (high-dose outliers) or lower (low-dose outliers) doses than what is recommended in medication package inserts. To describe the patterns of care for biologic-dosing outliers and nonoutliers in biologic-naive patients with RA. This was a retrospective, longitudinal cohort study of patients with RA who were not pregnant and were aged ≥ 18 and < 90 years from an integrated health care delivery system. Patients were newly initiated on adalimumab (ADA), etanercept (ETN), or infliximab (IFX) as index biologic therapy between July 1, 2006, and February 28, 2014. Outlier status was defined as a patient having received at least 1 dose < 90% or > 110% of the approved dose in the package insert at any time during the study period. Baseline patient profiles, treatment exposures, and outcomes were collected during the 180 days before and up to 2 years after biologic initiation and compared across index biologic outlier groups. Patients were followed for at least 1 year, with a subanalysis of those patients who remained as members for 2 years. This study included 434 RA patients with 1 year of follow-up and 372 RA patients with 2 years of follow-up. Overall, the vast majority of patients were female (≈75%) and had similar baseline characteristics. Approximately 10% of patients were outliers in both follow-up cohorts. ETN patients were least likely to become outliers, and ADA patients were most likely to become outliers. Of all outliers during the 1-year follow-up, patients were more likely to be a high-dose outlier (55%) than a low-dose outlier (45%). Median 1- and 2-year adjusted total biologic costs (based on wholesale acquisition costs) were higher for ADA and ETA nonoutliers than for IFX nonoutliers. Biologic persistence was highest for IFX patients. Charlson Comorbidity Index score, ETN and IFX index biologic, and treatment with a nonbiologic disease-modifying antirheumatic drug (DMARD) before biologic initiation were associated with becoming high- or low-dose outliers (c-statistic = 0.79). Approximately 1 in 10 study patients with RA was identified as a biologic-dosing outlier. Dosing outliers did not appear to have better clinical outcomes compared with nonoutliers. Before initiating outlier biologic dosing, health care providers may better serve their RA patients by prescribing alternate DMARD therapy. This study was sponsored by Janssen Scientific Affairs. It is the policy of Janssen Scientific Affairs to publish all sponsored studies unless they are exploratory studies or are determined a priori for internal use only (e.g., to inform business decisions). Meyer is an employee of Janssen Scientific Affairs and a stockholder in Johnson and Johnson, its parent company. Delate and Jenkins have nothing to disclose. Study concept and design were contributed by Delate and Meyer. Delate took the lead in data collection, along with Jenkins. All authors participated in data analysis. The manuscript was written primarily by Delate, along with Meyers and Jenkins, and was revised by Meyer, along with Delate and Jenkins.

Operational Definitions of Labor and Delivery Nursing Activities.

DTIC Science & Technology

1987-07-01

assess and record fetal heart rate. (S 2406 r) ZO!3 FETAL ELECTRODE INSERTION (RN): position patient, insert fetal electrode, secure monitor leads...to leg plate to patient’s lower extremity, connect, assess and record fetal heart rate. (S2405r) Z014 FETAL ELECTRODE INSERTION/INTRAUTERINE CATHETER...INSERTION, ASSIST: position patient for procedure, secure monitor Teads to patient’s lower extremity, assess and record fetal heart tones. Set up

Risk factors associated with PICC-related upper extremity venous thrombosis in cancer patients.

PubMed

Yi, Xiao-lei; Chen, Jie; Li, Jia; Feng, Liang; Wang, Yan; Zhu, Jia-An; Shen, E; Hu, Bing

2014-03-01

To investigate the incidence and risk factors for peripherally inserted central venous catheters-related upper extremity venous thrombosis in patients with cancer. With the widespread use of peripherally inserted central venous catheters, peripherally inserted central venous catheters-related upper extremity venous thrombosis in patients with cancer leads to increasing morbidity and mortality. It is very important to further explore the incidence and risk factors for peripherally inserted central venous catheters-related venous thrombosis. Consecutive patients with cancer who were scheduled to receive peripherally inserted central venous catheters, between September 2009 and May 2012, were prospectively studied in our centre. They were investigated for venous thrombosis by Doppler sonography three times a day within 30 days after catheter insertion. Univariable and multivariable logistic regressions' analyses were performed to identify the risk factors for peripherally inserted central venous catheters-related thrombosis. A total of 89 patients with cancer were studied in our research. Of these, 81 patients were followed up within one month. The mean interval between catheter insertion and the onset of thrombosis was 12.45 ± 6.17 days. The multivariable analyses showed that chemotherapy history, less activities and diabetes were the key risk factors for thrombosis. Peripherally inserted central venous catheters-related upper extremity venous thrombosis had high incidence rate, and most cases had no significant symptoms. The history of chemotherapy, less activities and diabetes were found to be the key risk factors. It should be routinely scanned in high-risk patients every 3-5 days after catheter insertion, which would then find blood clots in time and reduce the incidence of pulmonary embolism. Risk factors associated with peripherally inserted central venous catheters-related upper extremity venous thrombosis are of critical importance in improving the quality of patients' life. It is very important to grasp the indications to reduce the incidence rate of peripherally inserted central venous catheters-related upper extremity venous thrombosis. © 2013 John Wiley & Sons Ltd.

Forecasting patient outcomes in the management of hyperlipidemia.

PubMed

Brier, K L; Tornow, J J; Ries, A J; Weber, M P; Downs, J R

1999-03-22

To forecast adult patient outcomes in the management of hyperlipidemia using adult National Health and Examination Survey III (NHANES III) population statistics and National Cholesterol Education Program (NCEP) guidelines for goals of therapy. Review of the hyperlipidemia drug therapy English-language medical literature with emphasis on randomized controlled trials of more than 6 weeks' duration published in the last 7 years, product package inserts, US Food and Drug Administration submission information, and NHANES III population statistics. Data were extracted from studies of lipid-lowering therapy to modify low-density lipoprotein (LDL) levels for primary and secondary prevention of coronary heart disease. The data that were evaluated included sample size, study design, therapeutic intervention, length of study, percentage change in LDL levels, and patient demographics. Cumulative frequency curves of the LDL distribution among the US adult population were constructed. The mean efficacy of drug therapy from qualified studies was used to extrapolate the percentage of the population expected to respond to the intervention and to forecast the patient outcome. A useful tool for clinicians was constructed to approximate the percentage of patients, based on risk stratification, who would reach NCEP target goal after a given pharmacotherapeutic intervention to decrease LDL levels.

[Cocaine smuggling in the gastrointestinal tract--the case report with the review of literature].

PubMed

Ciszowski, Krzysztof; Hydzik, Piotr; Waldman, Wojciech; Sein Anand, Jacek

2005-01-01

Body-packing is the way of psychoactive substances smuggling by swallowing of carefully prepared packages with drugs into the gastrointestinal tract or by insertion them into the vagina or the rectum, especially in order to avoid finding them by the custom service. Cocaine, as well as opiates, is the one of the most often smuggled drugs by so called body-packers. In the present study the first case of the body-packer from Malopolska region in Poland, who was observed in the Toxicology Department of the Collegium Medicum UJ, was described. The 29-year-old man swallowed 60 packages containing cocaine with a total net weight of about 500 grams. The plain abdominal radiography revealed multiple shadows of foreign bodies in the gastrointestinal tract, but the results of blood and urine cocaine measurements were negative. During the 37-hours stay in our department the patient was monitored (blood pressure, heart rate, temperature), laxatives and oral fluids were administered. All the packages were evacuated through the natural way and it was followed up by the control abdominal radiography. No symptoms of acute cocaine intoxication or any other complications were observed. According to the case there is also the thorough review of literature presented including the kinds of body-packing, the diagnostic methods used in recognizing of body-packers and the ways of their treatment taking into consideration the conservative management as well as surgical methods.

Blood leak alarm interference by hydoxocobalamin is hemodialysis machine dependent.

PubMed

Sutter, M E; Clarke, M E; Cobb, J; Daubert, G P; Rathore, V S; Aston, L S; Poppenga, R H; Ford, J B; Owen, K P; Albertson, T E

2012-12-01

Hydroxocobalamin has been reported to interfere with the blood leak alarm on hemodialysis machines making it difficult to use this treatment modality after hydroxocobalamin infusion. The objective was to determine if this interference with hydroxocobalamin occurs across hemodialysis machines by different manufacturers. Additionally, we aimed to see if this represented a colorimetric interference alone or if it is the optical properties of hydroxocobalamin. Hydroxocobalamin was reconstituted per package insert. Food coloring was added to 0.9% saline to create the colors of the visual spectrum. Optical properties of absorbance and transmittance were measured. Hydroxocobalamin and the saline solutions were infused into the Fresenius 2008K™ and the Gambro Phoenix X36™ machines. Times were recorded from the start of the machine until the solution finished or the alarm triggered. When evaluating the Gambro Phoenix X36™ machine and dialysis circuit; the alarm did not trigger. In contrast, the blood leak alarm on the Fresenius 2008K™ machine was tripped by both the red solution and hydoxocobalamin infused per the package insert. The alarm stopped the machine between 128 and 132 seconds for the red solution and between 30 and 35 seconds with the hydroxocobalamin. Membranes of the circuits where the alarm tripped were examined and remained intact without blood. Results were validated on different machines with new circuits. Hydroxocobalamin infusion per package insert and the red saline solution prepared with Red Dye 40 both triggered the blood leak alarm and stopped the Fresenius 2008K™ machine. However, this was not true for the Gambro Phoenix X36™ machine as the alarm never triggered. The interference with the Fresenius 2008K™ appears colorimetric due to normal saline with Red Dye 40 triggering the alarm. We alert physicians to become familiar with the properties of individual dialysis machines prior to use of hydroxocobalamin. When facing difficulties with hemodialysis after the administration of hydroxocobalamin, consider attempting with a different manufactures machine or model if available or contact the manufacturer directly.

Direction of catheter insertion and the incidence of paresthesia during continuous epidural anesthesia in the elderly patients

PubMed Central

Kim, Jong-Hak; Lee, Jun Seop

2013-01-01

Background Continuous epidural anesthesia is useful for endoscopic urologic surgery, as mostly performed in the elderly patients. In such a case, it is necessary to obtain successful sacral anesthesia, and the insertion of epidural catheter in the caudad direction may be needed. However, continuous epidural catherization has been related to paresthesias. This study aimed to evaluate the effects of the direction of the catheter insertion on the incidence of paresthesias in the elderly patients. Methods Two hundred elderly patients scheduled for endoscopic urologic surgery were enrolled. The epidural catheter was inserted at L2-3, L3-4, and L4-5 using the Tuohy needle. In Group I (n = 100), the Tuohy needle with the bevel directed the cephalad during the catheter insertion. In Group II (n = 100), it directed the caudad. During the catheter insertion, an anesthesiologist evaluated the presence of paresthesias and the ease or difficulty during the catheter insertion. Results In Group I (n = 97), 15.5% of the patients had paresthesias versus 18.4% in Group II (n = 98), and there was no significant difference between the two groups. In paresthesia depending on the insertion site and the ease or difficulty during the catheter insertion, there were no significant differences between the two groups. Conclusions Our results concluded that the direction of epidural catheter insertion did not significantly influence the incidence of paresthesias in the elderly patients. PMID:23741568

Ultrathin endoscope flexibility can predict discomfort associated with unsedated transnasal esophagogastroduodenoscopy

PubMed Central

Ono, Satoshi; Niimi, Keiko; Fujishiro, Mitsuhiro; Nakao, Tomoko; Suzuki, Kazushi; Ohike, Yumiko; Kodashima, Shinya; Yamamichi, Nobutake; Yamazaki, Tsutomu; Koike, Kazuhiko

2013-01-01

AIM: To evaluate the effects of choice of insertion route and ultrathin endoscope types. METHODS: This prospective study (January-June 2012) included 882 consecutive patients who underwent annual health checkups. Transnasal esophagogastroduodenoscopy (EGD) was performed in 503 patients and transoral EGD in 235 patients using six types of ultrathin endoscopes. Patients were given a choice of insertion route, either transoral or transnasal, prior to EGD examination. For transoral insertion, the endoscope was equipped with a thin-type mouthpiece and tongue depressor. Conscious sedation was not used for any patient. EGD-associated discomfort was assessed using a visual analog scale (VAS; no discomfort 0- maximum discomfort 10). RESULTS: Rates of preference for transnasal insertion were significantly higher in male (male/female 299/204 vs 118/117) and younger patients (56.8 ± 11.2 years vs 61.3 ± 13.0 years), although no significant difference was found in VAS scores between transoral and transnasal insertion (3.9 ± 2.3 vs 4.1 ± 2.5). Multivariate analysis revealed that gender, age, operator, and endoscope were independent significant predictors of VAS for transnasal insertion, although gender, age, and endoscope were those for transoral insertion. Further analysis revealed only the endoscopic flexibility index (EFI) as an independent significant predictor of VAS for transnasal insertion. Both EFI and tip diameter were independent significant predictors of VAS for transoral insertion. CONCLUSION: Flexibility of ultrathin endoscopes can be a predictor of EGD-associated discomfort, especially in transnasal insertion. PMID:23858379

Advances in Anti-IgE Therapy

PubMed Central

Yalcin, Arzu Didem

2015-01-01

Omalizumab depletes free IgE in the blood and interstitial space and inhibits IgE binding to FcεRI on basophils, mast cells, and dendritic cells. We stopped omalizumab treatment after four years. Recurrences of urticaria symptoms were found to be higher in patients with chronic urticaria than recurrences of asthmatic symptoms in severe persistent asthma patients. For the very first time, we used omalizumab in symptomatic therapy of recurrent laryngeal oedema and urticaria attacks in a patient with postoperative pulmonary carcinoid tumor for eight months. During the four years of follow-up, no recurrence was noted in pulmonary carcinoid tumor. Control PET CT results revealed normal findings. After omalizumab treatment, laryngeal oedema and urticaria symptoms were decreased. The most common adverse reaction from omalizumab is injection site induration, injection site itching, injection site pain, and bruising but the package insert contains warnings regarding parasitic infections. While there are no reports of fatal anaphylaxis as a result of omalizumab, some cases have been serious and potentially life-threatening. Therefore, the FDA requires that people receiving omalizumab be monitored in the physician's office for a period of time after their injections. PMID:26075226

Which community care for patients with schizophrenic disorders? Packages of care provided by Departments of Mental Health in Lombardy (Italy).

PubMed

Lora, Antonio; Cosentino, Ugo; Gandini, Anna; Zocchetti, Carlo

2007-01-01

The treatment of schizophrenic disorders is the most important challenge for community care. The analysis focuses on packages of care provided to 23.602 patients with a ICD-10 diagnosis of schizophrenic disorder and treated in 2001 by the Departments of Mental Health in Lombardy, Italy. Packages of care refer to a mix of treatments provided to each patient during the year by different settings. Direct costs of the packages were calculated. Linear Discriminant Analysis has been used to link socio-demographic and diagnostic sub-groups of the patients to packages of care. People with schizophrenic disorders received relatively few care packages: only four packages involved more than 5%. Two thirds of the patients received only care provided by Community Mental Health Centres. In the other two packages with a percentage over 5%, the activity was provided by CMHCs, jointly with General Hospitals or Day Care Facilities. Complex care packages were rare (only 6%). As well as the intensity, also the variety of care provided by CMHCs increased with the complexity of care packages. In Lombardy more than half of the resources were spent for schizophrenia. The range of the costs per package was very wide. LDA failed to link characteristics of the patients to packages of care. Care packages are useful tools to understand better how mental health system works, how resources have been spent and to point out problems in the quality of care.

Virus-Like Particles Derived from HIV-1 for Delivery of Nuclear Proteins: Improvement of Production and Activity by Protein Engineering.

PubMed

Robert, Marc-André; Lytvyn, Viktoria; Deforet, Francis; Gilbert, Rénald; Gaillet, Bruno

2017-01-01

Virus-like particles (VLPs) derived from retroviruses and lentiviruses can be used to deliver recombinant proteins without the fear of causing insertional mutagenesis to the host cell genome. In this study we evaluate the potential of an inducible lentiviral vector packaging cell line for VLP production. The Gag gene from HIV-1 was fused to a gene encoding a selected protein and it was transfected into the packaging cells. Three proteins served as model: the green fluorescent protein and two transcription factors-the cumate transactivator (cTA) of the inducible CR5 promoter and the human Krüppel-like factor 4 (KLF4). The sizes of the VLPs were 120-150 nm in diameter and they were resistant to freeze/thaw cycles. Protein delivery by the VLPs reached up to 100% efficacy in human cells and was well tolerated. Gag-cTA triggered up to 1100-fold gene activation of the reporter gene in comparison to the negative control. Protein engineering was required to detect Gag-KLF4 activity. Thus, insertion of the VP16 transactivation domain increased the activity of the VLPs by eightfold. An additional 2.4-fold enhancement was obtained by inserting nuclear export signal. In conclusion, our platform produced VLPs capable of efficient protein transfer, and it was shown that protein engineering can be used to improve the activity of the delivered proteins as well as VLP production.

21 CFR 201.323 - Aluminum in large and small volume parenterals used in total parenteral nutrition.

Code of Federal Regulations, 2011 CFR

2011-04-01

... used in total parenteral nutrition. 201.323 Section 201.323 Food and Drugs FOOD AND DRUG ADMINISTRATION... parenteral nutrition. (a) The aluminum content of large volume parenteral (LVP) drug products used in total parenteral nutrition (TPN) therapy must not exceed 25 micrograms per liter (µg/L). (b) The package insert of...

21 CFR 201.323 - Aluminum in large and small volume parenterals used in total parenteral nutrition.

Code of Federal Regulations, 2012 CFR

2012-04-01

... used in total parenteral nutrition. 201.323 Section 201.323 Food and Drugs FOOD AND DRUG ADMINISTRATION... parenteral nutrition. (a) The aluminum content of large volume parenteral (LVP) drug products used in total parenteral nutrition (TPN) therapy must not exceed 25 micrograms per liter (µg/L). (b) The package insert of...

21 CFR 201.323 - Aluminum in large and small volume parenterals used in total parenteral nutrition.

Code of Federal Regulations, 2013 CFR

2013-04-01

... used in total parenteral nutrition. 201.323 Section 201.323 Food and Drugs FOOD AND DRUG ADMINISTRATION... parenteral nutrition. (a) The aluminum content of large volume parenteral (LVP) drug products used in total parenteral nutrition (TPN) therapy must not exceed 25 micrograms per liter (µg/L). (b) The package insert of...

21 CFR 201.323 - Aluminum in large and small volume parenterals used in total parenteral nutrition.

Code of Federal Regulations, 2010 CFR

2010-04-01

... used in total parenteral nutrition. 201.323 Section 201.323 Food and Drugs FOOD AND DRUG ADMINISTRATION... parenteral nutrition. (a) The aluminum content of large volume parenteral (LVP) drug products used in total parenteral nutrition (TPN) therapy must not exceed 25 micrograms per liter (µg/L). (b) The package insert of...

21 CFR 201.323 - Aluminum in large and small volume parenterals used in total parenteral nutrition.

Code of Federal Regulations, 2014 CFR

2014-04-01

... used in total parenteral nutrition. 201.323 Section 201.323 Food and Drugs FOOD AND DRUG ADMINISTRATION... parenteral nutrition. (a) The aluminum content of large volume parenteral (LVP) drug products used in total parenteral nutrition (TPN) therapy must not exceed 25 micrograms per liter (µg/L). (b) The package insert of...

Is antibiotic prophylaxis mandatory after the insertion of levonorgestrel-releasing intrauterine systemin order to decrease the risk of pelvic inflammatory disease?

PubMed

Munteanu, O; Radulescu, L; Bodean, O; Cirstoiu, C; Secara, D; Cirstoiu, M

2013-01-01

This study was undertaken in order to determine if antibiotic prophylaxis is mandatory, after the insertion of levonorgestrel-releasing intrauterine system in order to decrease the risk of pelvic inflammatory disease. We prospectively evaluated 44 patients, admitted in the Bucharest Emergency Hospital between the 1ⁱ of February 2012 and the 1ⁱ of October 2012, in whom the levonorgestrel-releasing intrauterine system was inserted. The patients enrolled were divided into two groups. In group A, a number of 22 patients, received, after the insertion of levonorgestrel-releasing intrauterine system, 875mg Amoxicillin Trihydrate + 125 mg Potassium Clavulanate, a dose every 12 hours for 5 days. Group B was represented by the other 22 patients who did not receive antibiotic prophylaxis. All patients were reevaluated at 4 and 12 weeks after the insertion of levonorgestrel-releasing intrauterine system. During the first 4 weeks after the insertion of levonorgestrel-releasing intrauterine system only two patients, one from group A and one from group B were diagnosed with pelvic inflammatory disease. At a second follow up visit - 12 weeks after the insertion of levonorgestrel-releasing intrauterine system, no other patient was diagnosed with pelvic inflammatory disease. Antibiotic prophylaxis is not mandatory, after the insertion of levonorgestrel-releasing intrauterine system in order to decrease the risk of pelvic inflammatory disease.

GSFC Cutting Edge Avionics Technologies for Spacecraft

NASA Technical Reports Server (NTRS)

Luers, Philip J.; Culver, Harry L.; Plante, Jeannette

1998-01-01

With the launch of NASA's first fiber optic bus on SAMPEX in 1992, GSFC has ushered in an era of new technology development and insertion into flight programs. Predating such programs the Lewis and Clark missions and the New Millenium Program, GSFC has spearheaded the drive to use cutting edge technologies on spacecraft for three reasons: to enable next generation Space and Earth Science, to shorten spacecraft development schedules, and to reduce the cost of NASA missions. The technologies developed have addressed three focus areas: standard interface components, high performance processing, and high-density packaging techniques enabling lower cost systems. To realize the benefits of standard interface components GSFC has developed and utilized radiation hardened/tolerant devices such as PCI target ASICs, Parallel Fiber Optic Data Bus terminals, MIL-STD-1773 and AS1773 transceivers, and Essential Services Node. High performance processing has been the focus of the Mongoose I and Mongoose V rad-hard 32-bit processor programs as well as the SMEX-Lite Computation Hub. High-density packaging techniques have resulted in 3-D stack DRAM packages and Chip-On-Board processes. Lower cost systems have been demonstrated by judiciously using all of our technology developments to enable "plug and play" scalable architectures. The paper will present a survey of development and insertion experiences for the above technologies, as well as future plans to enable more "better, faster, cheaper" spacecraft. Details of ongoing GSFC programs such as Ultra-Low Power electronics, Rad-Hard FPGAs, PCI master ASICs, and Next Generation Mongoose processors.

Insertable cardiac event recorder in detection of atrial fibrillation after cryptogenic stroke: an audit report.

PubMed

Etgen, Thorleif; Hochreiter, Manfred; Mundel, Markus; Freudenberger, Thomas

2013-07-01

Atrial fibrillation (AF) is the most frequent risk factor in ischemic stroke but often remains undetected. We analyzed the value of insertable cardiac event recorder in detection of AF in a 1-year cohort of patients with cryptogenic ischemic stroke. All patients with cryptogenic stroke and eligibility for oral anticoagulation were offered the insertion of a cardiac event recorder. Regular follow-up for 1 year recorded the incidence of AF. Of the 393 patients with ischemic stroke, 65 (16.5%) had a cryptogenic stroke, and in 22 eligible patients, an event recorder was inserted. After 1 year, in 6 of 22 patients (27.3%), AF was detected. These preliminary data show that insertion of cardiac event recorder was eligible in approximately one third of patients with cryptogenic stroke and detected in approximately one quarter of these patients new AF.

2012 drug packaging review: many dangerous, reportable flaws.

PubMed

2013-05-01

Drug packaging plays an important role in protecting and providing information to patients. The packaging examined by Prescrire in 2012, on the whole, still fails to perform all of these functions effectively. Two issues are especially worrisome. First, packaging too often poses a danger to children. In addition, too many patient leaflets provide incomplete information about adverse effects, thus failing to properly protect the most vulnerable patients. Yet, the method Prescrire used to analyse drug packaging shows that it is not difficult to detect and anticipate risks. It is up to healthcare professionals to take advantage of the method, to protect patients from, and report, dangerous packaging.

MEMS Direct Chip Attach Packaging Methodologies and Apparatuses for Harsh Environments

NASA Technical Reports Server (NTRS)

Okojie, Robert S. (Inventor)

2009-01-01

Methods of bulk manufacturing high temperature sensor subassembly packages are disclosed and claimed. Sensors are sandwiched between a top cover and a bottom cover so as to enable the peripheries of the top covers, sensors and bottom covers to be sealed and bound securely together are disclosed and claimed. Sensors are placed on the bottom covers leaving the periphery of the bottom cover exposed. Likewise, top covers are placed on the sensors leaving the periphery of the sensor exposed. Individual sensor sub-assemblies are inserted into final packaging elements which are also disclosed and claimed. Methods of directly attaching wires or pins to contact pads on the sensors are disclosed and claimed. Sensors, such as pressure sensors and accelerometers, and headers made out of silicon carbide and aluminum nitride are disclosed and claimed. Reference cavities are formed in some embodiments disclosed and claimed herein where top covers are not employed.

MEMS Direct Chip Attach Packaging Methodologies and Apparatuses for Harsh Environments

NASA Technical Reports Server (NTRS)

Okojie, Robert S. (Inventor)

2005-01-01

Methods of bulk manufacturing high temperature sensor sub-assembly packages are disclosed and claimed. Sensors are sandwiched between a top cover and a bottom cover so as to enable the peripheries of the top covers, sensors and bottom covers to be sealed and bound securely together are disclosed and claimed. Sensors are placed on the bottom covers leaving the periphery of the bottom cover exposed. Likewise, top covers are placed on the sensors leaving the periphery of the sensor exposed. Individual sensor sub- assemblies are inserted into final packaging elements which are also disclosed and claimed. Methods of directly attach- ing wires or pins to contact pads on the sensors are disclosed and claimed. Sensors, such as pressure sensors and accelerometers, and headers made out of silicon carbide and aluminum nitride are disclosed and claimed. Reference cavities are formed in some embodiments disclosed and claimed herein where top covers are not employed.

Use of peripherally inserted central catheters as an alternative to central catheters in neurocritical care units.

PubMed

DeLemos, Christi; Abi-Nader, Judy; Akins, Paul T

2011-04-01

Patients in neurological critical care units often have lengthy stays that require extended vascular access and invasive hemodynamic monitoring. The traditional approach for these patients has relied heavily on central venous and pulmonary artery catheters. The aim of this study was to evaluate peripherally inserted central catheters as an alternative to central venous catheters in neurocritical care settings. Data on 35 patients who had peripherally inserted central catheters rather than central venous or pulmonary artery catheters for intravascular access and monitoring were collected from a prospective registry of neurological critical care admissions. These data were cross-referenced with information from hospital-based data registries for peripherally inserted central catheters and subarachnoid hemorrhage. Complete data were available on 33 patients with Hunt-Hess grade IV-V aneurysmal subarachnoid hemorrhage. Catheters remained in place a total of 649 days (mean, 19 days; range, 4-64 days). One patient (3%) had deep vein thrombosis in an upper extremity. In 2 patients, central venous pressure measured with a peripherally inserted catheter was higher than pressure measured concurrently with a central venous catheter. None of the 33 patients had a central catheter bloodstream infection or persistent insertion-related complications. CONCLUSIONS Use of peripherally inserted central catheters rather than central venous catheters or pulmonary artery catheters in the neurocritical care unit reduced procedural and infection risk without compromising patient management.

Is antibiotic prophylaxis mandatory after the insertion of levonorgestrel-releasing intrauterine systemin order to decrease the risk of pelvic inflammatory disease?

PubMed Central

Munteanu, O; Radulescu, L; Bodean, O; Cirstoiu, C; Secara, D; Cirstoiu, M

2013-01-01

Abstract Objective: This study was undertaken in order to determine if antibiotic prophylaxis is mandatory, after the insertion of levonorgestrel-releasing intrauterine system in order to decrease the risk of pelvic inflammatory disease. Materials and methods: We prospectively evaluated 44 patients, admitted in the Bucharest Emergency Hospital between the 1ⁱ of February 2012 and the 1ⁱ of October 2012, in whom the levonorgestrel-releasing intrauterine system was inserted. The patients enrolled were divided into two groups. In group A, a number of 22 patients, received, after the insertion of levonorgestrel-releasing intrauterine system, 875mg Amoxicillin Trihydrate + 125 mg Potassium Clavulanate, a dose every 12 hours for 5 days. Group B was represented by the other 22 patients who did not receive antibiotic prophylaxis. All patients were reevaluated at 4 and 12 weeks after the insertion of levonorgestrel-releasing intrauterine system. Results: During the first 4 weeks after the insertion of levonorgestrel-releasing intrauterine system only two patients, one from group A and one from group B were diagnosed with pelvic inflammatory disease. At a second follow up visit – 12 weeks after the insertion of levonorgestrel-releasing intrauterine system, no other patient was diagnosed with pelvic inflammatory disease. Conclusion: Antibiotic prophylaxis is not mandatory, after the insertion of levonorgestrel-releasing intrauterine system in order to decrease the risk of pelvic inflammatory disease. PMID:24868262

High-energy metal air batteries

DOEpatents

Zhang, Ji-Guang; Xiao, Jie; Xu, Wu; Wang, Deyu; Williford, Ralph E.; Liu, Jun

2014-07-01

Disclosed herein are embodiments of lithium/air batteries and methods of making and using the same. Certain embodiments are pouch-cell batteries encased within an oxygen-permeable membrane packaging material that is less than 2% of the total battery weight. Some embodiments include a hybrid air electrode comprising carbon and an ion insertion material, wherein the mass ratio of ion insertion material to carbon is 0.2 to 0.8. The air electrode may include hydrophobic, porous fibers. In particular embodiments, the air electrode is soaked with an electrolyte comprising one or more solvents including dimethyl ether, and the dimethyl ether subsequently is evacuated from the soaked electrode. In other embodiments, the electrolyte comprises 10-20% crown ether by weight.

High-energy metal air batteries

DOEpatents

Zhang, Ji-Guang; Xiao, Jie; Xu, Wu; Wang, Deyu; Williford, Ralph E.; Liu, Jun

2013-07-09

Disclosed herein are embodiments of lithium/air batteries and methods of making and using the same. Certain embodiments are pouch-cell batteries encased within an oxygen-permeable membrane packaging material that is less than 2% of the total battery weight. Some embodiments include a hybrid air electrode comprising carbon and an ion insertion material, wherein the mass ratio of ion insertion material to carbon is 0.2 to 0.8. The air electrode may include hydrophobic, porous fibers. In particular embodiments, the air electrode is soaked with an electrolyte comprising one or more solvents including dimethyl ether, and the dimethyl ether subsequently is evacuated from the soaked electrode. In other embodiments, the electrolyte comprises 10-20% crown ether by weight.

Increasing use of less-invasive hemodynamic monitoring in 3 specialty surgical intensive care units: a 5-year experience at a tertiary medical center.

PubMed

Kirton, Orlando C; Calabrese, Rebecca C; Staff, Ilene

2015-01-01

Less-invasive hemodynamic monitoring (eg, esophageal doppler monitoring [EDM] and arterial pressure contour analysis, FloTrac) is increasingly used as an alternative to pulmonary artery catheters (PACs) in critically ill intensive care unit (ICU). The decrease in use of PACs is not associated with increased mortality. Five-year retrospective review of 1894 hemodynamically monitored patients admitted to 3 surgical ICUs in a university-affiliate, tertiary care urban hospital. Data included the number of admissions, diagnosis-related group discharge case mix, length of stay, insertion of monitoring devices (PAC, EDM, and FloTrac probes), administered intravenous vasoactive agents (β-predominant agonists--dobutamine, epinephrine, and dopamine; vasopressors--norepinephrine and phenylephrine), and mortality. Data from hospital administrative databases were compiled to create patient characteristic and monitoring variables across a 5-year time period, 2005 to 2009 inclusive. Chi-square for independent proportions, 1-way analysis of variance, and Kruskal-Wallis tests were used; tests for trend were conducted. An α level of .05 was considered significant. Statistical Package for the Social Sciences v14 was used for all statistical testing. There was a significant change in the type of hemodynamic monitors inserted in 2 of the 3 surgical ICUs (in the general surgery and neurointensive care but not in the cardiac ICU) from PACs to less-invasive devices (FloTrac or EDM) during the 5-year study period (P < .001). There was no change in mortality rate over the time period (P = .492). There was an overall increase in the proportion of monitored patients who received intravenous vasoactive agents (P < .001) with a progressive shift from β-agonists to vasopressors (P < .002). Multivariate analyses indicated that age, case mix, and use of vasoactive agents were all independent predictors of inhospital mortality (P = .001) but that type of monitoring was not (P = .638). In a 5-year period, the decreased insertions of PACs were replaced by increased utilization of less-invasive hemodynamic monitoring devices. This change in practice did not adversely impact mortality. © The Author(s) 2013.

Management of computed tomography-detected pneumothorax in patients with blunt trauma: experience from a community-based hospital

PubMed Central

Hefny, Ashraf F; Kunhivalappil, Fathima T; Matev, Nikolay; Avila, Norman A; Bashir, Masoud O; Abu-Zidan, Fikri M

2018-01-01

INTRODUCTION Diagnoses of pneumothorax, especially occult pneumothorax, have increased as the use of computed tomography (CT) for imaging trauma patients becomes near-routine. However, the need for chest tube insertion remains controversial. We aimed to study the management of pneumothorax detected on CT among patients with blunt trauma, including the decision for tube thoracostomy, in a community-based hospital. METHODS Chest CT scans of patients with blunt trauma treated at Al Rahba Hospital, Abu Dhabi, United Arab Emirates, from October 2010 to October 2014 were retrospectively studied. Variables studied included demography, mechanism of injury, endotracheal intubation, pneumothorax volume, chest tube insertion, Injury Severity Score, hospital length of stay and mortality. RESULTS CT was performed in 703 patients with blunt trauma. Overall, pneumothorax was detected on CT for 74 (10.5%) patients. Among the 65 patients for whom pneumothorax was detected before chest tube insertion, 25 (38.5%) needed chest tube insertion, while 40 (61.5%) did not. Backward stepwise likelihood regression showed that independent factors that significantly predicted chest tube insertion were endotracheal intubation (p = 0.01), non-United Arab Emirates nationality (p = 0.01) and pneumothorax volume (p = 0.03). The receiver operating characteristic curve showed that the best pneumothorax volume that predicted chest tube insertion was 30 mL. CONCLUSION Chest tube was inserted in less than half of the patients with blunt trauma for whom pneumothorax was detected on CT. Pneumothorax volume should be considered in decision-making regarding chest tube insertion. Conservative treatment may be sufficient for pneumothorax of volume < 30 mL. PMID:28741012

Management of computed tomography-detected pneumothorax in patients with blunt trauma: experience from a community-based hospital.

PubMed

Hefny, Ashraf F; Kunhivalappil, Fathima T; Matev, Nikolay; Avila, Norman A; Bashir, Masoud O; Abu-Zidan, Fikri M

2018-03-01

Diagnoses of pneumothorax, especially occult pneumothorax, have increased as the use of computed tomography (CT) for imaging trauma patients becomes near-routine. However, the need for chest tube insertion remains controversial. We aimed to study the management of pneumothorax detected on CT among patients with blunt trauma, including the decision for tube thoracostomy, in a community-based hospital. Chest CT scans of patients with blunt trauma treated at Al Rahba Hospital, Abu Dhabi, United Arab Emirates, from October 2010 to October 2014 were retrospectively studied. Variables studied included demography, mechanism of injury, endotracheal intubation, pneumothorax volume, chest tube insertion, Injury Severity Score, hospital length of stay and mortality. CT was performed in 703 patients with blunt trauma. Overall, pneumothorax was detected on CT for 74 (10.5%) patients. Among the 65 patients for whom pneumothorax was detected before chest tube insertion, 25 (38.5%) needed chest tube insertion, while 40 (61.5%) did not. Backward stepwise likelihood regression showed that independent factors that significantly predicted chest tube insertion were endotracheal intubation (p = 0.01), non-United Arab Emirates nationality (p = 0.01) and pneumothorax volume (p = 0.03). The receiver operating characteristic curve showed that the best pneumothorax volume that predicted chest tube insertion was 30 mL. Chest tube was inserted in less than half of the patients with blunt trauma for whom pneumothorax was detected on CT. Pneumothorax volume should be considered in decision-making regarding chest tube insertion. Conservative treatment may be sufficient for pneumothorax of volume < 30 mL. Copyright: © Singapore Medical Association.

Clinical implications of acute pelvicaliceal hematoma formation during percutaneous catheter nephrostomy insertion.

PubMed

Stewart, Jessica K; Smith, Tony P; Kim, Charles Y

To determine the clinical implications of acute pelvicaliceal hematoma formation during percutaneous catheter nephrostomy (PCN) insertion. Collecting system hematoma burden was retrospectively assessed for 694 PCN insertions in 502 patients. Pelvicaliceal hematoma formation occurred in 146 kidneys (21%) in 136 patients. Clinically significant blood loss occurred in 3 patients with hematomas within one week compared to 4 patients without hematomas (p=0.39). Twenty-four patients with hematomas underwent catheter exchange within one week, compared to 55 patients without hematomas (p=0.49). Pelvicaliceal hematoma formation after PCN insertion is not uncommon and is associated with very rare clinical sequelae. Copyright © 2017 Elsevier Inc. All rights reserved.

Diagnostic packages can be assigned accurately in emergency departments. A multi-centre cohort study.

PubMed

Nørgaard, Birgitte; Mogensen, Christian Backer; Teglbjærg, Lars Stubbe; Brabrand, Mikkel; Lassen, Annmarie Touborg

2016-06-01

In the Region of Southern Denmark, the emergency departments categorise patients based on presenting symptoms and a proposed diagnostic package (n = 40) within each category. The diagnostic packages describe relevant clinical information and standard laboratory and other investigations to be performed. Allocation to the right diagnostic package is assumed to be associated with a higher quality. The aim of this study was to describe to which degree the assigned symptom-based diagnostic packages are related to relevant discharge diagnoses. This was a descriptive cohort study. The analysis was based on data on assigned diagnostic package, patient discharge diagnosis, hospital, gender, age, time of admission and discharge, length of stay, diagnostic package assigned, discharge diagnosis and co-morbidity. An acceptable standard for what would be an appropriate primarily diagnostic package was developed using a modified Delphi method. A total of 16,543 patient contacts were identified. Women constituted 52.2% (n = 8,925) of the patients. The median age was 64 years and the median length of stay was one day. All diagnostic packages were represented. A total of 68% of the included patients had been assigned an acceptable diagnostic package (95% confidence interval: 67.2-68.7). We found an appropriate use of one of 30 diagnostic packages in more than 50% of the cases. We found that 68% of the included patients were assigned an acceptable diagnostic package and that about 80% of all acute pathways were covered by 14 diagnostic packages. The study was funded by Region of Southern Denmark. The study was registered with the Danish Data Protection Agency (No. 2008-58-0035). No further approval was required.

MEMS Reliability Assurance Guidelines for Space Applications

NASA Technical Reports Server (NTRS)

Stark, Brian (Editor)

1999-01-01

This guide is a reference for understanding the various aspects of microelectromechanical systems, or MEMS, with an emphasis on device reliability. Material properties, failure mechanisms, processing techniques, device structures, and packaging techniques common to MEMS are addressed in detail. Design and qualification methodologies provide the reader with the means to develop suitable qualification plans for the insertion of MEMS into the space environment.

Graphical content of medicinal package inserts: an exploratory study to evaluate potential legibility issues.

PubMed

Pires, Carla; Vigário, Marina; Cavaco, Afonso

2016-06-01

The graphical content of the Medicines Package Inserts (MPIs), such as illustrations and typographic features should be legible and appropriate, as required by international pharmaceutical regulations. To study: (1) the frequency and type of MPIs' key graphic elements, (2) their compliance with regulations and (3) how educated people understand them. Descriptive study: characterisation of the graphical content of 651 MPIs. Usability study: illustrations and tables (purposively selected) were evaluated with questionnaires in three groups of humanities undergraduates (illustrations only, illustrations plus text and text only). Descriptive study: illustrations and tables were respectively identified in 6.3% and 11.8% of the MPIs. The illustrations were mainly related to how to take/use the medicine. Non-recommended graphical representations were found (e.g. italic or underline). Usability test: legibility issues were identified, especially for the group of isolated illustrations. The scarce use of illustrations and tables possibly affected the legibility of the MPIs. Compulsory legibility tests are needed to guarantee the MPIs' proper use, thus contributing to a safe use of medicines. Overall, this study highlighted the need to carefully revise/assess the MPIs' design and probably increase health information experts' awareness on this issue. © 2015 Health Libraries Group.

An audit of the complications of intercostal chest drain insertion in a high volume trauma service in South Africa

PubMed Central

Oosthuizen, GV; Sartorius, B; Keene, C; Clarke, DL

2014-01-01

Introduction Intercostal chest drain (ICD) insertion is a commonly performed procedure in trauma and may be associated with significant morbidity. Methods This was a retrospective review of ICD complications in a major trauma service in South Africa over a four-year period from January 2010 to December 2013. Results A total of 1,050 ICDs were inserted in 1,006 patients, of which 91% were male. The median patient age was 24 years (interquartile range [IQR]: 20–29 years). There were 962 patients with unilateral ICDs and 44 with bilateral ICDs. Seventy-five per cent (758/1,006) sustained penetrating trauma and the remaining 25% (248/1006) sustained blunt trauma. Indications for ICD insertion were: haemopneumothorax (n=338), haemothorax (n=314), simple pneumothorax (n=265), tension pneumothorax (n=79) and open pneumothorax (n=54). Overall, 203 ICDs (19%) were associated with complications: 18% (36/203) were kinked, 18% (36/203) were inserted subcutaneously, 13% (27/203) were too shallow and in 7% (14/203) there was inadequate fixation resulting in dislodgement. Four patients (2%) sustained visceral injuries and two sustained vascular injuries. Forty-one per cent (83/203) were inserted outside the ‘triangle of safety’ but without visceral or vascular injuries. One patient had the ICD inserted on the wrong side. Junior doctors inserted 798 ICDs (76%) while senior doctors inserted 252 (24%). Junior doctors had a significantly higher complication rate (24%) compared with senior doctors (5%) (p<0.001). There was no mortality as a direct result of ICD insertion. Conclusions ICD insertion is associated with a high rate of complications. These complications are significantly higher when junior doctors perform the procedure. A multifaceted quality improvement programme is needed to improve the situation. PMID:25350185

An audit of the complications of intercostal chest drain insertion in a high volume trauma service in South Africa.

PubMed

Kong, V Y; Oosthuizen, G V; Sartorius, B; Keene, C; Clarke, D L

2014-11-01

Intercostal chest drain (ICD) insertion is a commonly performed procedure in trauma and may be associated with significant morbidity. This was a retrospective review of ICD complications in a major trauma service in South Africa over a four-year period from January 2010 to December 2013. A total of 1,050 ICDs were inserted in 1,006 patients, of which 91% were male. The median patient age was 24 years (interquartile range [IQR]: 20-29 years). There were 962 patients with unilateral ICDs and 44 with bilateral ICDs. Seventy-five per cent (758/1,006) sustained penetrating trauma and the remaining 25% (248/1006) sustained blunt trauma. Indications for ICD insertion were: haemopneumothorax (n=338), haemothorax (n=314), simple pneumothorax (n=265), tension pneumothorax (n=79) and open pneumothorax (n=54). Overall, 203 ICDs (19%) were associated with complications: 18% (36/203) were kinked, 18% (36/203) were inserted subcutaneously, 13% (27/203) were too shallow and in 7% (14/203) there was inadequate fixation resulting in dislodgement. Four patients (2%) sustained visceral injuries and two sustained vascular injuries. Forty-one per cent (83/203) were inserted outside the 'triangle of safety' but without visceral or vascular injuries. One patient had the ICD inserted on the wrong side. Junior doctors inserted 798 ICDs (76%) while senior doctors inserted 252 (24%). Junior doctors had a significantly higher complication rate (24%) compared with senior doctors (5%) (p<0.001). There was no mortality as a direct result of ICD insertion. Conclusions ICD insertion is associated with a high rate of complications. These complications are significantly higher when junior doctors perform the procedure. A multifaceted quality improvement programme is needed to improve the situation.

Factors affecting colonoscope insertion time in patients with or without a colostomy after left-sided colorectal resection.

PubMed

Jang, Hui Won; Kim, Yoon Nam; Nam, Chung Mo; Lee, Hyun Jung; Park, Soo Jung; Hong, Sung Pil; Kim, Tae Il; Kim, Won Ho; Cheon, Jae Hee

2012-12-01

We examined whether the insertion time for colonoscopies performed after left-sided resection was different in patients with a colostomy from that in patients without a colostomy and identified factors that could impact colonoscopy performance. We included consecutive patients who underwent colonoscopy between July 2005 and March 2011 after left-sided colorectal resection for colorectal cancer. We classified surgical methods according to the presence or absence of a colostomy and evaluated colonoscope insertion time retrospectively. Furthermore, we analyzed factors that might affect insertion time. A total of 1,041 patients underwent colonoscopy after left-sided colorectal resection during the study period. The colonoscopy completion rate was 98.6 %, and the mean insertion time was 6.1 ± 4.6 min (median 4.7 min, range 0.3-35.8 min). A shorter resection length of colon, the presence of a colostomy, and a lower endoscopist case volume were found to be independent factors associated with prolonged insertion time in patients with left-sided colorectal resection. Among experienced colonoscopists, no colonoscopy-associated or clinical factors were found to affect insertion time. However, a shorter resection length of colon, the presence of a colostomy, and poor bowel preparation were associated with prolonged insertion time among inexperienced endoscopists. We identified three factors that affect colonoscope insertion time after left-sided colorectal resection, including the presence of a colostomy. Inexperienced endoscopists were much more affected by the presence of a colostomy after left-sided colorectal resection. These findings have implications for the practice and teaching of colonoscopy after left-sided colorectal resection.

Cardiac output increases prior to development of pulmonary edema after re-expansion of spontaneous pneumothorax.

PubMed

Tan, H C; Mak, K H; Johan, A; Wang, Y T; Poh, S C

2002-06-01

Pulmonary edema following reexpansion of spontaneous pneumothorax is an uncommon complication. The underlying mechanism of this condition is unclear. We report the hemodynamic characteristics in a series of 7 male patients with spontaneous large (>50%) pneumothoraces of > or = 24 h and correlate the changes with reexpansion pulmonary edema (REPE). A pulmonary artery floatation catheter was inserted and hemodynamic data were obtained before therapeutic chest tube insertion, 1 h after chest tube insertion and the following day. Four (57%) patients developed REPE. There was a tendency for larger pneumothorax to develop REPE. Capillary wedge pressure did not change significantly 1 h after the insertion of chest tube in all our patients. Cardiac output increased significantly in patients who developed REPE compared to those who did not (+ 1.06 l/min vs -0.27 l/min; P = 0.03) 1 h after insertion of chest tube. One patient did not develop pulmonary edema despite having a large (> 80%) pneumothorax. His cardiac output did not rise 1 h after chest tube insertion. REPE is not an uncommon complication following chest tube drainage in patients with large and long-standing pneumothorax. The increase in cardiac output after chest tube insertion may be associated with subsequent development of REPE.

Antegrade Ureteral Stenting is a Good Alternative for the Retrograde Approach.

PubMed

van der Meer, Rutger W; Weltings, Saskia; van Erkel, Arian R; Roshani, Hossain; Elzevier, Henk W; van Dijk, Lukas C; van Overhagen, Hans

2017-07-01

Double J (JJ) stents for treating obstructive ureteral pathology are generally inserted through a retrograde route with cystoscopic guidance. Antegrade percutaneous insertion using fluoroscopy can be performed alternatively but is less known. Indications, success rate and complications of antegrade ureteral stenting were evaluated. Data of consecutive patients in which antegrade ureteral stenting was performed were retrospectively analysed using the radiology information system and patient records. Patient characteristics, details of the antegrade JJ stent insertion procedure and registered complications were collected. Furthermore, it was investigated if prior to the antegrade procedure a retrograde attempt for JJ stent insertion was performed. Total 130 attempts for antegrade JJ stent insertion were performed in 100 patients. A percutaneous nephrostomy catheter had already been placed in the majority of kidneys (n = 109) for initial treatment of hydronephrosis. Most prevelant indication for a JJ stent was obstructive ureteral pathology due to malignancy (n = 63). A JJ stent was successfully inserted in 125 of 130 procedures. In 21 cases, previous retrograde ureteral stenting had failed but, subsequent antegrade ureteral stenting was successful. There were 8 procedure related complications; 6 infections, 1 false tract and 1 malposition. Antegrade percutaneous insertion of a JJ stent is a good alternative for retrograde insertion.

Development of a clinical prediction rule to improve peripheral intravenous cannulae first attempt success in the emergency department and reduce post insertion failure rates: the Vascular Access Decisions in the Emergency Room (VADER) study protocol

PubMed Central

Carr, Peter J; Rippey, James C R; Cooke, Marie L; Bharat, Chrianna; Murray, Kevin; Higgins, Niall S; Foale, Aileen; Rickard, Claire M

2016-01-01

Introduction Peripheral intravenous cannula (PIVC) insertion is one of the most common clinical interventions performed in emergency care worldwide. However, factors associated with successful PIVC placement and maintenance are not well understood. This study seeks to determine the predictors of first time PIVC insertion success in emergency department (ED) and identify the rationale for removal of the ED inserted PIVC in patients admitted to the hospital ward. Reducing failed insertion attempts and improving peripheral intravenous cannulation practice could lead to better staff and patient experiences, as well as improving hospital efficiency. Methods and analysis We propose an observational cohort study of PIVC insertions in a patient population presenting to ED, with follow-up observation of the PIVC in subsequent admissions to the hospital ward. We will collect specific PIVC observational data such as; clinician factors, patient factors, device information and clinical practice variables. Trained researchers will gather ED PIVC insertion data to identify predictors of insertion success. In those admitted from the ED, we will determine the dwell time of the ED-inserted PIVC. Multivariate regression analyses will be used to identify factors associated with insertions success and PIVC failure and standard statistical validation techniques will be used to create and assess the effectiveness of a clinical predication rule. Ethics and dissemination The findings of our study will provide new evidence to improve insertion success rates in the ED setting and identify strategies to reduce premature device failure for patients admitted to hospital wards. Results will unravel a complexity of factors that contribute to unsuccessful PIVC attempts such as patient and clinician factors along with the products, technologies and infusates used. Trial registration number ACTRN12615000588594; Pre-results. PMID:26868942

Development of a clinical prediction rule to improve peripheral intravenous cannulae first attempt success in the emergency department and reduce post insertion failure rates: the Vascular Access Decisions in the Emergency Room (VADER) study protocol.

PubMed

Carr, Peter J; Rippey, James C R; Cooke, Marie L; Bharat, Chrianna; Murray, Kevin; Higgins, Niall S; Foale, Aileen; Rickard, Claire M

2016-02-11

Peripheral intravenous cannula (PIVC) insertion is one of the most common clinical interventions performed in emergency care worldwide. However, factors associated with successful PIVC placement and maintenance are not well understood. This study seeks to determine the predictors of first time PIVC insertion success in emergency department (ED) and identify the rationale for removal of the ED inserted PIVC in patients admitted to the hospital ward. Reducing failed insertion attempts and improving peripheral intravenous cannulation practice could lead to better staff and patient experiences, as well as improving hospital efficiency. We propose an observational cohort study of PIVC insertions in a patient population presenting to ED, with follow-up observation of the PIVC in subsequent admissions to the hospital ward. We will collect specific PIVC observational data such as; clinician factors, patient factors, device information and clinical practice variables. Trained researchers will gather ED PIVC insertion data to identify predictors of insertion success. In those admitted from the ED, we will determine the dwell time of the ED-inserted PIVC. Multivariate regression analyses will be used to identify factors associated with insertions success and PIVC failure and standard statistical validation techniques will be used to create and assess the effectiveness of a clinical predication rule. The findings of our study will provide new evidence to improve insertion success rates in the ED setting and identify strategies to reduce premature device failure for patients admitted to hospital wards. Results will unravel a complexity of factors that contribute to unsuccessful PIVC attempts such as patient and clinician factors along with the products, technologies and infusates used. ACTRN12615000588594; Pre-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

The Impact of Preoperative α-Adrenergic Antagonists on Ureteral Access Sheath Insertion Force and the Upper Limit of Force Required to Avoid Ureteral Mucosal Injury: A Randomized Controlled Study.

PubMed

Koo, Kyo Chul; Yoon, Jun-Ho; Park, No-Cheol; Lee, Hye Sun; Ahn, Hyun Kyu; Lee, Kwang Suk; Kim, Do Kyung; Cho, Kang Su; Chung, Byung Ha; Hong, Chang Hee

2018-06-01

Excessive bulking force during primary access of the ureteral access sheath may induce ureteral injury. We investigated the efficacy of preoperative α-blockade to reduce ureteral access sheath insertion force and determine the upper limit required to avoid ureteral injury. In this randomized controlled trial 135 patients from a single institution who had ureteropelvic junction or renal pelvis stones and were scheduled to undergo retrograde intrarenal surgery were prospectively enrolled from December 2015 to January 2017. Of the patients 41 and 42 were randomly assigned to the control and experimental groups, respectively. The experimental group received α-blockade preoperatively. The 21 patients who were pre-stented were assessed separately. We developed a homemade device to measure maximal ureteral access sheath insertion force. Our ureteral access sheath insertion force measurement device showed excellent reproducibility. Higher insertion velocity resulted in greater maximal sheath insertion force. Maximal insertion force in the α-blockade group was significantly lower than in the control group at the ureterovesical junction (p = 0.008) and the proximal ureter (p = 0.036). Maximal insertion force in the α-blockade group was comparable to that in pre-stented patients. Female patients and patients 70 years old or older showed a lower maximal ureteral access sheath insertion force than their counterparts. The rate of grade 2 or greater ureteral injury was lower in the α-blockade group than in controls (p = 0.038). No injury occurred in any case in which ureteral access sheath insertion force did not exceed 600 G. Preoperative α-blockade and slow sheath placement may reduce maximal ureteral access sheath insertion force. If the force exceeds 600 G, a smaller diameter sheath may be an alternative. Alternatively the procedure can be terminated and followed later by pre-stented retrograde intrarenal surgery. Copyright © 2018 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

Unilateral versus bilateral stent insertion for malignant hilar biliary obstruction.

PubMed

Chang, Gang; Xia, Feng-Fei; Li, Hong-Fu; Niu, Su; Xu, Yuan-Shun

2017-11-01

To determine the clinical efficiency and long-term outcomes between unilateral and bilateral stent insertion in patients with malignant hilar biliary obstruction. From August 2012 to February 2016, 63 consecutive patients with malignant hilar biliary obstruction were treated with unilateral or bilateral stent insertion at our center. The bilateral stents were inserted using the side-by-side technique. The clinical efficiency and long-term outcomes were compared between the two groups. Unilateral and bilateral stent insertions were successfully performed in 31 of 33 and 27 of 30 patients, respectively (P = 0.912). No procedure-related complication occurred. Clinical success was achieved in 29 of 31 patients in the unilateral stent group and in 26 of 27 patients in the bilateral stent group (P = 0.637). During the follow-up, re-obstruction of stent occurred in five patients in the unilateral stent group and in three patients in the bilateral stent group (P = 0.58). The significant differences were not observed in the stent patency time (368 vs. 387 days, P = 0.685) and survival (200 vs. 198 days, P = 0.751) between two groups. Based on the univariate and multivariate analyses, the independent risk factors for decreasing the survival time included higher Eastern Cooperative Oncology Group performance status (P = 0.018), higher alanine aminotransferase level (P = 0.009), and absence of anticancer treatment after stent insertion (P = 0.002). Compared to bilateral stent insertion for malignant hilar biliary obstruction, unilateral stent insertion can provide comparable clinical efficiency and long-term outcomes.

Comparative analysis of package inserts of local and imported antihypertensive medications in Palestine.

PubMed

Qatmosh, Sandra A; Koni, Amer A; Qeeno, Baraa G; Arandy, Dina A; Abu-Hashia, Maysa W; Al-Hroub, Bahaa M; Zyoud, Sa'ed H

2017-09-25

Package inserts (PIs) as a reliable reference for patients and health care providers should provide accurate, complete and up-to-date information. The purpose of the current study is to assess and compare the PIs of antihypertensive agents locally produced in Palestine and their imported counterparts. Thirty-five PIs were assessed for the presence of 31 information statements using a scoring method. Word counting of 20 headings and subheadings was used to evaluate and compare local and imported PIs for information quantity. None of the analysed PIs fulfilled the criteria. All of them included the brand name, active ingredients, indications, directions for use, adverse drug reactions, drug-drug interactions, pregnancy and lactation considerations, and storage. Whereas none of them, either local or imported PIs, included the shelf life and instructions to convert tablets or capsules into liquid forms. Additionally, only one (5%) imported and no (0%) local PIs mentioned the duration of therapy. Moreover, 93.4% of local PIs were deficient in areas regarding the inactive ingredients and date of last revision, and 86.7% did not mention the drug dose and possibility of tablet splitting. Furthermore, the maximum dose was not indicated in 90% of imported and 86.7% of local PIs. In general, imported PIs contained more detailed information than their local counterparts, where the range of differences in medians between the local and imported PIs was from 1.5-fold for pregnancy considerations to >42.00-fold for the effect on the ability to drive and use machines. The findings of this study revealed the superiority of imported over local PIs in both quality and quantity of information provided. This emphasises the need for appropriate measures to be taken by the Ministry of Health and local manufacturers to ensure efficiency of local PIs in providing accurate, complete and up-to-date information.

How to optimise antimicrobial prescriptions in the Intensive Care Unit: principles of individualised dosing using pharmacokinetics and pharmacodynamics.

PubMed

Roberts, Jason A; Joynt, Gavin M; Choi, Gordon Y S; Gomersall, Charles D; Lipman, Jeffrey

2012-03-01

Optimising antimicrobial dosing for critically ill patients is highly challenging and when it is not achieved can lead to worse patient outcomes. To this end, use of dosing regimens recommended in package inserts from drug manufacturers is frequently insufficient to guide dosing in these patients appropriately. Whilst the effect of critical illness pathophysiology on the pharmacokinetic (PK) behaviour of antimicrobials can be profound, the variability of these changes between patients is still being quantified. The PK effects of hypoproteinaemia, organ dysfunction and the presence of augmented renal clearance may lead to plasma antimicrobial concentrations that are difficult to predict at the bedside, which may result in excess toxicity or suboptimal bacterial killing. This paper outlines the factors that affect pharmacokinetics in critically ill patients and how knowledge of these factors can increase the likelihood of achieving optimal antimicrobial plasma concentrations. In selected settings, we advocate individualised dosing of renally cleared antimicrobials using physiological data such as measured creatinine clearance and published non-renal clearance data. Where such data do not exist, therapeutic drug monitoring may be a useful alternative and has been associated with significant clinical benefits, although it is not currently widely available. Copyright © 2011 Elsevier B.V. and the International Society of Chemotherapy. All rights reserved.

A small and efficient dimerization/packaging signal of rat VL30 RNA and its use in murine leukemia virus-VL30-derived vectors for gene transfer.

PubMed

Torrent, C; Gabus, C; Darlix, J L

1994-02-01

Retroviral genomes consist of two identical RNA molecules associated at their 5' ends by the dimer linkage structure located in the packaging element (Psi or E) necessary for RNA dimerization in vitro and packaging in vivo. In murine leukemia virus (MLV)-derived vectors designed for gene transfer, the Psi + sequence of 600 nucleotides directs the packaging of recombinant RNAs into MLV virions produced by helper cells. By using in vitro RNA dimerization as a screening system, a sequence of rat VL30 RNA located next to the 5' end of the Harvey mouse sarcoma virus genome and as small as 67 nucleotides was found to form stable dimeric RNA. In addition, a purine-rich sequence located at the 5' end of this VL30 RNA seems to be critical for RNA dimerization. When this VL30 element was extended by 107 nucleotides at its 3' end and inserted into an MLV-derived vector lacking MLV Psi +, it directed the efficient encapsidation of recombinant RNAs into MLV virions. Because this VL30 packaging signal is smaller and more efficient in packaging recombinant RNAs than the MLV Psi + and does not contain gag or glyco-gag coding sequences, its use in MLV-derived vectors should render even more unlikely recombinations which could generate replication-competent viruses. Therefore, utilization of the rat VL30 packaging sequence should improve the biological safety of MLV vectors for human gene transfer.

A fully wafer-level packaged RF MEMS switch with low actuation voltage using a piezoelectric actuator

NASA Astrophysics Data System (ADS)

Park, Jae-Hyoung; Lee, Hee-Chul; Park, Yong-Hee; Kim, Yong-Dae; Ji, Chang-Hyeon; Bu, Jonguk; Nam, Hyo-Jin

2006-11-01

In this paper, a fully wafer-level packaged RF MEMS switch has been demonstrated, which has low operation voltage, using a piezoelectric actuator. The piezoelectric actuator was designed to operate at low actuation voltage for application to advanced mobile handsets. The dc contact type RF switch was packaged using the wafer-level bonding process. The CPW transmission lines and piezoelectric actuators have been fabricated on separate wafers and assembled together by the wafer-level eutectic bonding process. A gold and tin composite was used for eutectic bonding at a low temperature of 300 °C. Via holes interconnecting the electrical contact pads through the wafer were filled completely with electroplated copper. The fully wafer-level packaged RF MEMS switch showed an insertion loss of 0.63 dB and an isolation of 26.4 dB at 5 GHz. The actuation voltage of the switch was 5 V. The resonant frequency of the piezoelectric actuator was 38.4 kHz and the spring constant of the actuator was calculated to be 9.6 N m-1. The size of the packaged SPST (single-pole single-through) switch was 1.2 mm × 1.2 mm including the packaging sealing rim. The effect of the proposed package structure on the RF performance was characterized with a device having CPW through lines and vertical feed lines excluding the RF switches. The measured packaging loss was 0.2 dB and the return loss was 33.6 dB at 5 GHz.

Evaluation of preferable insertion routes for esophagogastroduodenoscopy using ultrathin endoscopes

PubMed Central

Ono, Satoshi; Niimi, Keiko; Fujishiro, Mitsuhiro; Takahashi, Yu; Sakaguchi, Yoshiki; Nakayama, Chiemi; Minatsuki, Chihiro; Matsuda, Rie; Hirayama-Asada, Itsuko; Tsuji, Yosuke; Mochizuki, Satoshi; Kodashima, Shinya; Yamamichi, Nobutake; Ozeki, Atsuko; Matsumoto, Lumine; Ohike, Yumiko; Yamazaki, Tsutomu; Koike, Kazuhiko

2014-01-01

AIM: To evaluate the discomfort associated with esophagogastroduodenoscopy (EGD) using an ultrathin endoscope through different insertion routes. METHODS: This study (January 2012-March 2013) included 1971 consecutive patients [male/female (M/F), 1158/813, 57.5 ± 11.9 years] who visited a single institute for annual health checkups. Transnasal EGD was performed in 1394 patients and transoral EGD in 577. EGD-associated discomfort was assessed using a visual analog scale score (VAS score: 0-10). RESULTS: Multivariate analysis revealed gender (M vs F: 4.02 ± 2.15 vs 5.06 ± 2.43) as the only independent predictor of the VAS score in 180 patients who underwent EGD for the first time; whereas it revealed gender (M vs F 3.60 ± 2.20 vs 4.84 ± 2.37), operator, age group (A: < 39 years; B: 40-49 years; C: 50-59 years; D: 60-69 years; E: > 70 years; A/B/C/D/E: 4.99 ± 2.32/4.34 ± 2.49/4.19 ± 2.31/3.99 ± 2.27/3.63 ± 2.31), and type of insertion as independent predictors in the remaining patients. Subanalysis for gender, age group, and insertion route revealed that the VAS score decreased with age regardless of gender and insertion route, was high in female patients regardless of age and insertion route, and was low in males aged over 60 years who underwent transoral insertion. CONCLUSION: Although comprehensive analysis revealed that the insertion route may not be an independent predictor of the VAS score, transoral insertion may reduce EGD-associated discomfort in elderly patients. PMID:24803817

Effect of the starting point of half-pin insertion on the insertional torque of the pin at the tibia.

PubMed

Kim, Sung Jae; Kim, Sung Hwan; Kim, Young Hwan; Chun, Yong Min

2015-01-01

The authors have observed a failure to achieve secure fixation in elderly patients when inserting a half-pin at the anteromedial surface of the tibia. The purpose of this study was to compare two methods for inserting a half-pin at tibia diaphysis in elderly patients. Twenty cadaveric tibias were divided into Group C or V. A half-pin was inserted into the tibias of Group C via the conventional method, from the anteromedial surface to the interosseous border of the tibia diaphysis, and into the tibias of Group V via the vertical method, from the anterior border to the posterior surface at the same level. The maximum insertion torque was measured during the bicortical insertion with a torque driver. The thickness of the cortex was measured by micro-computed tomography. The relationship between the thickness of the cortex engaged and the insertion torque was investigated. The maximum insertion torque and the thickness of the cortex were significantly higher in Group V than Group C. Both groups exhibited a statistically significant linear correlation between torque and thickness by Spearman's rank correlation analysis. Half-pins inserted by the vertical method achieved purchase of more cortex than those inserted by the conventional method. Considering that cortical thickness and insertion torque in Group V were significantly greater than those in Group C, we suggest that the vertical method of half-pin insertion may be an alternative to the conventional method in elderly patients.

Ureteric stent dwelling time: a risk factor for post-ureteroscopy sepsis.

PubMed

Nevo, Amihay; Mano, Roy; Baniel, Jack; Lifshitz, David A

2017-07-01

To evaluate the association between stent dwelling time and sepsis after ureteroscopy, and identify risk factors for sepsis in this setting. The prospectively collected database of a single institution was queried for all patients who underwent ureteroscopy for stone extraction between 2010 and 2016. Demographic, clinical, preoperative and operative data were collected. The primary study endpoint was sepsis within 48 h of ureteroscopy. Logistic regressions were performed to identify predictors of post-ureteroscopy sepsis in the ureteroscopy cohort and specifically in patients with prior stent insertion. Between October 2010 and April 2016, 1 256 patients underwent ureteroscopy for stone extraction. Risk factors for sepsis included prior stent placement, female gender and Charlson comorbidity index. A total of 601 patients had a ureteric stent inserted before the operation and were included in the study cohort, in which the median age was 56 years, 90 patients were women (30%), and 97 patients were treated for positive preoperative urine cultures (16.1%). Postoperative sepsis, <48 h after surgery, occurred in eight (1.2%) non-stented patients and in 28 patients (4.7%) with prior stent insertion. Sepsis rates after stent dwelling times of 1, 2, 3 and >3 months were 1, 4.9, 5.5 and 9.2%, respectively. On multivariate analysis, stent dwelling time, stent insertion because of sepsis, and female gender were significantly associated with post-ureteroscopy sepsis in patients with prior stent placement. Patients who undergo ureteroscopy after ureteric stent insertion have a higher risk of postoperative sepsis. Prolonged stent dwelling time, sepsis as an indication for stent insertion, and female gender are independent risk factors. Stent placement should be considered cautiously, and if inserted, ureteroscopy should be performed within 1 month. © 2017 The Authors BJU International © 2017 BJU International Published by John Wiley & Sons Ltd.

Highly Crosslinked-remelted versus Less-crosslinked Polyethylene in Posterior Cruciate-retaining TKAs in the Same Patients.

PubMed

Kim, Young-Hoo; Park, Jang-Won; Kim, Jun-Shik; Lee, June-Hyung

2015-11-01

Concern regarding osteolysis attributable to polyethylene wear after TKA, particularly in younger patients, has prompted the introduction of highly crosslinked-remelted polyethylene (HXLPE) for TKAs. However, few in vivo comparative results of TKAs using HXLPE and less-crosslinked polyethylene inserts in the same patients are available, regarding fracture or failure of the locking mechanism of tibial polyethylene inserts or of osteolysis in patients younger than 60 years. We wanted to determine whether (1) survivorship free from aseptic loosening in knees with HXLPE inserts was different from survivorship in knees with less-crosslinked polyethylene inserts, (2) the prevalence of fracture or failure of the locking mechanism of the tibial polyethylene insert was greater in knees with HXLPE than in those with less-crosslinked polyethylene, and (3) the proportion of patients who had osteolysis develop was greater with HXLPE than with less-crosslinked polyethylene inserts. One hundred seventy-one patients with a mean age of 58 ± 8 years (range, 35-59 years) received posterior cruciate-retaining prostheses with a less-crosslinked polyethylene tibial insert in one knee and a HXLPE tibial insert in the contralateral knee. From January 2007 to January 2010, we performed 366 same-day bilateral simultaneous sequential posterior cruciate-retaining TKAs in 183 patients, of whom 171 (93%) participated in this study. All patients during this study period underwent posterior cruciate-retaining TKAs regardless of deformity of the knees and we did not perform posterior-stabilized TKAs during the same period. Patients who had bilateral end-stage osteoarthritis and were younger than 60 years were selected for inclusion. Six patients (4%) were lost to followup before 5 years. Twenty-six patients were males and 145 were females. The mean duration of followup was 6 years (range, 5-8 years). At each followup, patients were assessed for loosening of the components, fracture or failure of the locking mechanism of the polyethylene inserts, or osteolysis. The survival rate of the knee prosthesis at a mean of 5.8 years after surgery was 100% (95% CI, 0.95-1.00) in both groups for the endpoint aseptic loosening and 99.4% (95% CI, 0.95-1.00) in both groups for the endpoint revision. No knee in either group had fracture or failure of the locking mechanism of the tibial polyethylene insert, and none had osteolysis. With the numbers available, we found no clinically important differences between HXLPE and less-crosslinked polyethylene inserts in posterior cruciate-retaining TKAs. Given that HXLPE is newer, as-yet unproven, and more expensive than the proven technology (less-crosslinked polyethylene), we suggest not adopting HXLPE for clinical use until it shows superiority. Level I, therapeutic study.

2011 drug packaging review: too many dangers and too many patients overlooked.

PubMed

2012-05-01

Every year, Prescrire's analysis of drug packaging confirms the importance of taking packaging into account in assessing a drug's harm-benefit balance. Safe, tried and true options are available, yet the quality of most of the drug packaging Prescrire examined in 2011 left much to be desired. Few of the packaging items examined help prevent medication errors and many actually increase the risks: misleading and confusing labelling, dosing devices that create a risk of overdose, bottles without a child-proof cap, and inadequate or dangerous patient information leaflets. Umbrella brands continue to expand and are a potential source of medication errors. Some patients are at greater risk: the patient leaflets for NSAIDs endanger pregnant women and their unborn babies; children are insufficiently protected by paediatric packaging and are at risk due to the lack of child-proof caps on too many bottles. The raft of regulatory measures taken by the French drug regulatory agency (Afssaps) in the aftermath of the Mediator disaster overlooked the importance of packaging. Until drug regulatory agencies tackle the vast issue of drug packaging, it is up to healthcare professionals to protect patients from harm.

Antegrade Ureteral Stenting is a Good Alternative for the Retrograde Approach

PubMed Central

van der Meer, Rutger W.; Weltings, Saskia; van Erkel, Arian R.; Roshani, Hossain; Elzevier, Henk W.; van Dijk, Lukas C.; van Overhagen, Hans

2017-01-01

Background/Aims Double J (JJ) stents for treating obstructive ureteral pathology are generally inserted through a retrograde route with cystoscopic guidance. Antegrade percutaneous insertion using fluoroscopy can be performed alternatively but is less known. Indications, success rate and complications of antegrade ureteral stenting were evaluated. Methods Data of consecutive patients in which antegrade ureteral stenting was performed were retrospectively analysed using the radiology information system and patient records. Patient characteristics, details of the antegrade JJ stent insertion procedure and registered complications were collected. Furthermore, it was investigated if prior to the antegrade procedure a retrograde attempt for JJ stent insertion was performed. Results Total 130 attempts for antegrade JJ stent insertion were performed in 100 patients. A percutaneous nephrostomy catheter had already been placed in the majority of kidneys (n = 109) for initial treatment of hydronephrosis. Most prevelant indication for a JJ stent was obstructive ureteral pathology due to malignancy (n = 63). A JJ stent was successfully inserted in 125 of 130 procedures. In 21 cases, previous retrograde ureteral stenting had failed but, subsequent antegrade ureteral stenting was successful. There were 8 procedure related complications; 6 infections, 1 false tract and 1 malposition. Conclusion Antegrade percutaneous insertion of a JJ stent is a good alternative for retrograde insertion. PMID:28785193

Pancreatic stents for the prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis should be inserted up to the pancreatic body or tail.

PubMed

Sugimoto, Mitsuru; Takagi, Tadayuki; Suzuki, Rei; Konno, Naoki; Asama, Hiroyuki; Sato, Yuki; Irie, Hiroki; Watanabe, Ko; Nakamura, Jun; Kikuchi, Hitomi; Waragai, Yuichi; Takasumi, Mika; Hikichi, Takuto; Ohira, Hiromasa

2018-06-14

To investigate the location to which a pancreatic stent should be inserted to prevent post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). Over a ten-year period at our hospital, 296 patients underwent their first ERCP procedure and had a pancreatic stent inserted; this study included 147 patients who had ERCP performed primarily for biliary investigation and had a pancreatic stent inserted to prevent PEP. We divided these patients into two groups: 131 patients with a stent inserted into the pancreatic head (head group) and 16 patients with a stent inserted up to the pancreatic body or tail (body/tail group). Patient characteristics and ERCP factors were compared between the groups. Pancreatic amylase isoenzyme (p-AMY) levels in the head group were significantly higher than those in the body/tail group [138.5 (7.0-2086) vs 78.5 (5.0-1266.5), P = 0.03] [median (range)]. No cases of PEP were detected in the body/tail group [head group, 12 (9.2%)]. Of the risk factors for post-ERCP hyperamylasemia (≥ p-AMY median, 131 IU/L), procedure time ≥ 60 min [odds ratio (OR) 2.65, 95%CI: 1.17-6.02, P = 0.02) and stent insertion into the pancreatic head (OR 3.80, 95%CI: 1.12-12.9, P = 0.03) were identified as independent risk factors by multivariate analysis. Stent insertion up to the pancreatic body or tail reduces the risk of post-ERCP hyperamylasemia and may reduce the risk of PEP.

Influence of the Thermal Conductivity of Thermally Conductive Plastics on the Thermal Distribution of an Light-Emitting Diode Headlight for Vehicles.

PubMed

Lee, Dong Kyu; Lee, Jae Min; Cho, Moon Uk; Park, Hyun Jung; Cha, Yu-Jung; Kim, Hyeong Jin; Kwak, Joon Seop

2018-09-01

This paper investigates the thermal distribution of an LED headlight for vehicles based on the thermal conductivity of thermally conductive plastics (TCP). In general, heat dissipation structures used for LED headlights are made from metallic materials. However, headlight structures made from TCP have not been investigated. The headlights made from TCP having a various thermal conductivity were fabricated by injection molding with and without a metal plate insert. The temperature characteristics were compared and analyzed using thermal simulations and measurement. The inserted metal in TCP greatly reduced the temperature at solder point, indicating that the fast heat dissipation from the high power LED package to TCP though the inserted metal is essential. The measured temperature at solder points decreased as the thermal conductivity of TCP increased, which is well matched to the simulation results. The measured temperature at the solder point was lower than 150 °C when the thermal conductivity of the TCP was 10 W/mK.

Influence of Hydroxyapatite Stick on Pedicle Screw Fixation in Degenerative Lumbar Spine: Biomechanical and Radiologic Study.

PubMed

Shin, Sung Joon; Lee, Ji-Ho; Lee, Jae Hyup

2017-07-01

A prospective, within-patient, left-right comparative study. To evaluate the efficacy of hydroxyapatite (HA) stick augmentation method by comparing the insertional torque of the pedicle screw in osteoporotic and nonosteoporotic patients. Unsatisfactory clinical outcomes after spine surgery in osteoporotic patients are related to pedicle screw loosening or pull-outs. HA, as a bone graft extender, has a possibility to enhance the fixation strength at the bone-screw interface. From November 2009 to December 2010, among patients who required bilateral pedicle screw fixation for lumbar spine surgery, 22 patients were enrolled, who recieved unilateral HA stick augmentation and completed intraoperative insertional torque measurement of each pedicle screws. On the basis of preoperative evaluation of bone mineral density, patients with osteoporosis had 2 HA sticks inserted unilaterally, and 1 stick for patients without osteoporosis. Pedicle screw loosening and pull-outs were assessed using 12-month postoperative CT scans and follow-up radiographs. Clinical evaluation was done preoperatively and at 1 year postoperatively, based on Visual Analog Scale score, Oswestry Disability Index, and Short Form-36 Health Survey. Regardless of bone mineral density, the average torque value of all pedicle screws with HA stick insertion (HA stick inserted group) was significantly higher than that of all pedicle screws without HA insertion (control group) (P<0.0001). Same results were seen in the HA stick inserted subgroups and the control subgroups within both of the osteoporosis group (P=0.009) and the nonosteoporosis group (P=0.0004). There was no statistically significant difference of the rate of pedicle screw loosening in between the HA stick inserted group and the control group. Clinical evaluation also showed no statistically significant difference in between patients with loosening and those without. The enhancement of initial pedicle screw fixation strength in osteoporotic patients can be achieved by HA stick augmentation.

Practically prepared? Pre-intern student views following an education package.

PubMed

McKenzie, Susan; Mellis, Craig

2017-01-01

Graduating medical students enter their internship with varied levels of practical experience in procedural skills. To address this problem, many medical schools have introduced intensive skill training courses immediately prior to graduation. This study examines the impact of a pre-intern (PrInt) education package, consisting of a short intensive course, followed by a one-month clinical attachment. In September 2014, all PrInt students (n = 53) at the Central Clinical School (Sydney, NSW, Australia) attended three days of intensive training. This included a didactic introduction, case-based scenarios, and interactive workshops. This was followed by four weeks of targeted, experiential learning during a clinical attachment (PrInt term). Immediately prior to training and following PrInt, all students were invited to complete a six-domain questionnaire containing 40 subscale closed questions to assess their knowledge, experience, and confidence in key practical skills essential for a successful internship. A total of 41/53 (77%) students completed an identical questionnaire prior to PrInt, and 37/53 (70%) immediately following PrInt. Respondents reported statistically significant increases in their experience, ability, knowledge, and confidence in a number of domains. The key changes were the following: knowledge of pharmacy skills (mean improvement = 26.48, confidence interval 95% [CI 95%] = 17.29-35.66, p ≤ 0.0001) and management of procedural skills (mean = 24.46, CI 95% = 16.58-32.34, p ≤ 0.0001). Despite the positive overall increase in most domains, some subscale results remained low following the educational package; only 44% students had inserted a nasogastric tube; only 44% reported confidence in commencing patients on warfarin; and only 42% in managing a hospital emergency. Surprisingly, there was a slight decline both in confidence in communicating with members of the hospital team (10%) and in awareness of the causes of hypoglycemia (7%). Final year students perceived substantial benefit from an educational package specifically aimed at improving their practical skills immediately prior to internship.

Practically prepared? Pre-intern student views following an education package

PubMed Central

McKenzie, Susan; Mellis, Craig

2017-01-01

Background Graduating medical students enter their internship with varied levels of practical experience in procedural skills. To address this problem, many medical schools have introduced intensive skill training courses immediately prior to graduation. This study examines the impact of a pre-intern (PrInt) education package, consisting of a short intensive course, followed by a one-month clinical attachment. Methods In September 2014, all PrInt students (n = 53) at the Central Clinical School (Sydney, NSW, Australia) attended three days of intensive training. This included a didactic introduction, case-based scenarios, and interactive workshops. This was followed by four weeks of targeted, experiential learning during a clinical attachment (PrInt term). Immediately prior to training and following PrInt, all students were invited to complete a six-domain questionnaire containing 40 subscale closed questions to assess their knowledge, experience, and confidence in key practical skills essential for a successful internship. Results A total of 41/53 (77%) students completed an identical questionnaire prior to PrInt, and 37/53 (70%) immediately following PrInt. Respondents reported statistically significant increases in their experience, ability, knowledge, and confidence in a number of domains. The key changes were the following: knowledge of pharmacy skills (mean improvement = 26.48, confidence interval 95% [CI 95%] = 17.29–35.66, p ≤ 0.0001) and management of procedural skills (mean = 24.46, CI 95% = 16.58–32.34, p ≤ 0.0001). Despite the positive overall increase in most domains, some subscale results remained low following the educational package; only 44% students had inserted a nasogastric tube; only 44% reported confidence in commencing patients on warfarin; and only 42% in managing a hospital emergency. Surprisingly, there was a slight decline both in confidence in communicating with members of the hospital team (10%) and in awareness of the causes of hypoglycemia (7%). Conclusion Final year students perceived substantial benefit from an educational package specifically aimed at improving their practical skills immediately prior to internship. PMID:28184172

An alphavirus temperature-sensitive capsid mutant reveals stages of nucleocapsid assembly

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

Zheng, Yan, E-mail: yzheng15@students.kgi.edu; Kielian, Margaret, E-mail: margaret.kielian@einstein.yu.edu

2015-10-15

Alphaviruses have a nucleocapsid core composed of the RNA genome surrounded by an icosahedral lattice of capsid protein. An insertion after position 186 in the capsid protein produced a strongly temperature-sensitive growth phenotype. Even when the structural proteins were synthesized at the permissive temperature (28 °C), subsequent incubation of the cells at the non-permissive temperature (37 °C) dramatically decreased mutant capsid protein stability and particle assembly. Electron microscopy confirmed the presence of cytoplasmic nucleocapsids in mutant-infected cells cultured at the permissive temperature, but these nucleocapsids were not stable to sucrose gradient separation. In contrast, nucleocapsids isolated from mutant virus particlesmore » had similar stability to that of wildtype virus. Our data support a model in which cytoplasmic nucleocapsids go through a maturation step during packaging into virus particles. The insertion site lies in the interface between capsid proteins in the assembled nucleocapsid, suggesting the region where such a stabilizing transition occurs. - Highlights: • We characterize an alphavirus capsid insertion mutation. • These capsid mutants are highly temperature sensitive for growth. • The insertion affects nucleocapsid stability. • Results suggest that the nucleocapsid is stabilized during virus budding.« less

Foley catheter placement for induction of labor with or without stylette: a randomized clinical trial.

PubMed

Forgie, Marie M; Greer, Danielle M; Kram, Jessica J F; Vander Wyst, Kiley B; Salvo, Nicole P; Siddiqui, Danish S

2016-03-01

Foley catheters are used for cervical ripening during induction of labor. Previous studies suggest that use of a stylette (a thin, rigid wire) to guide catheter insertion decreases insertion failure. However, stylette effects on insertion outcomes have been sparsely studied. The purpose of this study was to compare catheter insertion times, patient-assessed pain levels, and insertion failure rates between women who received a digitally placed Foley catheter for cervical ripening with the aid of a stylette and women who received the catheter without a stylette. We conducted a randomized clinical trial of women aged ≥ 18 years who presented for induction of labor. Inclusion criteria were singletons with intact membranes and cephalic presentation. Women received a computer-generated random assignment of a Foley catheter insertion with a stylette (treatment group, n = 62) or without a stylette (control group, n = 61). For all women, a standard insertion technique protocol was used. Three primary outcomes were of interest, including the following: (1) insertion time (total minutes to successful catheter placement), (2) patient-assessed pain level (0-10), and (3) failure rate of the randomly assigned insertion method. Treatment control differences were first examined using the Pearson's test of independence and the Student t test. Per outcome, we also constructed 4 regression models, each including the random effect of physician and fixed effects of stylette use with patient nulliparity, a history of vaginal delivery, cervical dilation at presentation, or postgraduate year of the performing resident physician. Women who received the Foley catheter with the stylette vs without the stylette did not differ by age, race/ethnicity, body mass index, or any of several other characteristics. Regression models revealed that insertion time, patient pain, and insertion failure were unrelated to stylette use, nulliparity, and history of vaginal delivery. However, overall insertion time and failure were significantly influenced by cervical dilation, with insertion time decreasing by 21% (95% confidence interval [CI], 5-34%) and odds of failure decreasing by 71% (odds ratio, 0.29; 95% CI, 0.10-0.86) per 1 cm dilation. Resident postgraduate year also significantly influenced insertion time, with greater time required of physicians with less experience. Mean insertion time was 51% (95% CI, 23-69%) shorter for fourth-year than second-year residents. Statistically nonsignificant but prominent patterns in outcomes were also observed, suggesting stylette use may lengthen the overall insertion procedure but minimize variability in pain levels and decrease insertion failure. The randomized trial suggests that, even after accounting for nulliparity, history of vaginal delivery, cervical dilation, and physician experience, Foley catheter insertions with and without a stylette are equivalent in insertion times, patient pain levels, and failure of catheter placement. Copyright © 2016 Elsevier Inc. All rights reserved.

Accessing packaged food and beverages in hospital. Exploring experiences of patients and staff.

PubMed

Bell, A F; Walton, K; Chevis, J S; Davies, K; Manson, C; Wypych, A; Yoxall, A; Kirkby, J; Alexander, N

2013-01-01

Food and beverage packaging has been identified as a contributing factor to malnutrition among elderly patients in hospitals. The focus of this research was to describe the types of food and beverage packaging used in NSW hospitals, determine the 'problematic' packaging from the users' perspective, investigate the effect of hand strength on the ability to open the packaging and to survey users' (patients and staff) views on the 'accessibility' of the packaging. The study was conducted in the Illawarra region of NSW, Australia. Participants (140 mostly elderly inpatients and 64 staff members) were recruited from four local public hospitals. Data were collected using interviews, questionnaires, observations and grip strength testing. Several food and beverage packages were found difficult to open by at least 40% of patients. These included milk and juices (52%), cereal (49%), condiments (46%), tetra packs (40%) and water bottles (40%). The difficulties were attributed to 'fiddly' packaging, hand strength and vision; however, only tetra packs demonstrated a relationship between time taken to open and hand strength, suggesting other aspects of hand function may be more important than strength when opening food and beverage packages. Crown Copyright © 2012. Published by Elsevier Ltd. All rights reserved.

[High prevalence of off-label and unlicensed drug prescribing in a Brazilian intensive care unit].

PubMed

Ferreira, Lilian de Abreu; Ibiapina, Cássio da Cunha; Machado, Márcia Gomes Penido; Fagundes, Eleonora Druve Tavares

2012-01-01

To describe the use and determine the prevalence of off-label and unlicensed drug use prescribing in a pediatric intensive care unit in a Southeastern Brazilian hospital Cross-sectional study of inpatients in a pediatric intensive care unit from May 2008 through January 2009. The classification according to the Brazilian regulatory agency (Agência de Vigilância Sanitária - Anvisa) approval criteria was based on the Anvisa electronic package insert list, Pharmaceuticals Dictionary, and the analysis was conducted through R software. We analysed 1,054 prescription items for 73 patients. Females predominated (52%), and the patients' age ranged from 0 to 16 years. Among the prescribed items, 23.4% were off-label, 12.6% were unlicensed, 1.4% were both off-label and unlicensed, 86% had at least one item off-label, and 67% had at least one unlicensed drug. The most frequently prescribed therapeutic groups were systemic anti-bacterial, analgesic, psycholeptic, and antiasmathic agents. The current study results confirm the high prevalence of unlicensed and off-label drug use in a pediatric intensive care unit.

Peripherally inserted central catheters in the neonatal period.

PubMed

Uygun, Ibrahim; Okur, Mehmet Hanifi; Otcu, Selcuk; Ozturk, Hayrettin

2011-10-01

Peripherally inserted central catheters (PICC) have been extensively used in neonates. However, insertion of these thinnest catheters is a very delicate procedure associated with a high failure rate. In our Neonatal Surgical Intensive Care Unit, we developed a very easy new PICC insertion and evaluated the neonates treated with PICCs which were inserted by using our technique as well as catheter features such as success rate, number of insertion attempts, reason for removal and complications. Information was retrospectively collected on all 40 PICCs inserted at Kutahya Evliya Celebi Goverment Hospital and Dicle University Hospital during a 6-years period from September 2004 to September 2010. A total of 40 PICCs were inserted in 37 patients (26, 70% males, 11, 30% females) by using new technique. The median age of patients was 8.3 days (range 1 to 66 days) and the median weight of patients was 2365 g (range 600 to 5000 g). The vein most commonly accessed was long saphenous vein (85%). The length of PICCs in the body was 19.6 cm (range 5 cm to 30 cm). The tip was located in a central vein in all patients. Surgical abdomen was the most common cause for PICC insertion (38%). Duration of catheterization was 7.7±5.6 days (1-F 5.5 days, 2-F 8.6 days). Almost all of the PICCs were inserted successfully (40/42, success rate 95%) and in the first venipucture (36/42, 86%). Completion of therapy and removed after death were achieved with 87% of PICCs. Three minor complications were noted. Minor bleeding in the insertion site which was stopped via compression occurred in two neonates. Major complication was not seen. No deaths were directly attributed to PICCs use. The new insertion technique of the neonatal peripherally inserted central catheters may be one of the easiest and safest techniques, in comparison to previous techniques reported in the literature.

In-office insertion of a miniaturized insertable cardiac monitor: Results from the Reveal LINQ In-Office 2 randomized study.

PubMed

Rogers, John D; Sanders, Prashanthan; Piorkowski, Christopher; Sohail, M Rizwan; Anand, Rishi; Crossen, Karl; Khairallah, Farhat S; Kaplon, Rachelle E; Stromberg, Kurt; Kowal, Robert C

2017-02-01

Recent miniaturization of an insertable cardiac monitor (ICM) may make it possible to move device insertion from a hospital to office setting. However, the safety of this strategy is unknown. The primary objective was to compare the safety of inserting the Reveal LINQ ICM in an office vs a hospital environment. Ancillary objectives included summarizing device- and procedure-related adverse events and responses to a physician questionnaire. Five hundred twenty-one patients indicated for an ICM were randomized (1:1 ratio) to undergo ICM insertion in a hospital or office environment at 26 centers in the United States in the Reveal LINQ In-Office 2 study (ClinicalTrials.gov identifier NCT02395536). Patients were followed for 90 days. ICM insertion was successful in all 482 attempted patients (office: 251; hospital: 231). The untoward event rate (composite of unsuccessful insertion and ICM- or insertion-related complications) was 0.8% (2 of 244) in the office and 0.9% (2 of 227) in the hospital (95% confidence interval, -3.0% to 2.9%; 5% noninferiority: P < .001). In addition, adverse events occurred during 2.5% (6 of 244) of office and 4.4% (10 of 227) of hospital insertions (95% confidence interval [office minus inhospital rates], -5.8% to 1.9%; 5% noninferiority: P < .001). Physicians indicated that for procedures performed in an office vs a hospital, there were fewer delays >15 minutes (16% vs 35%; P < .001) and patient response was more often "very positive." Physicians considered the office location "very convenient" more frequently than the hospital location (85% vs 27%; P < .001). The safety profile for the insertion of the Reveal LINQ ICM is excellent irrespective of insertion environment. These results may expand site of service options for LINQ insertion. Copyright © 2016 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

A powerful enhancement to the DMAP alter capability

NASA Technical Reports Server (NTRS)

Pamidi, P. R.

1989-01-01

A powerful enhancement to the DMAP alter capability was developed and is available on all RPK-supported versions of COSMIC/NASTRAN. This enhancement involves the addition of two alter control cards, called INSERT and DELETE, to the Executive Control Deck. These cards allow for DMAP alters to be made by referencing DMAP statements by their module names rather than by their statement numbers in the rigid format DMAP sequence. This allows for increased user convenience and flexibility and makes alters more meaningful to the user. In addition, DMAP alter packages employing the alter control cards will be much less susceptible to future changes in rigid format DMAPs than alter packages employing the standard ALTER control cards. The usage of the cards is illustrated by examples.

[Sixteen Cases of Colon Stenting as a Bridge to Surgery(BTS)for Obstructive Colorectal Cancer].

PubMed

Otsuka, Ryo; Saito, Shuji; Hirayama, Ryouichi; Miura, Yasuaki; Sasaki, Kazunori; Miyajima, Ayako; Kuwamoto, Nobutsuna; Kataoka, Ryoko; Shindo, Yukito; Fujita, Rikiya

2017-11-01

Colonic stent insertion is widely used as a bridge to surgery(BTS)for obstructive colorectal cancer. Stenting can shorten hospitalization and decrease complication and colostomy rates in comparison with emergency surgery. We investigated patients who underwent colonic stent insertion for BTS in our hospital. Sixteen patients(8 men, 8 women) with a colorectal obstruction score of 0 or 1 who underwent colonic stent insertion as a BTS between April 2015 and April 2017 period were investigated. Mean patient age was 68.2(45-94)years. Technical success was obtained in all patients, and clinical success in 14(87%). Total colonoscopy was possible via stent in 10 patients. Nine patients were temporarily discharged from the hospital, and median time to operation was 18(2-43)days. Laparoscopic resection was performed in 14 patients, and anastomotic leakage was a postoperative complication in 1 patient. Colostomy was performed in only 1 patient with anastomotic leakage. Good results were obtained with careful patient selection and safe colonic stent insertion.

Remifentanil dose for laryngeal mask airway insertion with a single standard dose of propofol during emergency airway management in elderly patients.

PubMed

Ryu, Junghee; Oh, Ah Young; Baek, Ji-Seok; Kim, Jin-Hee; Park, Sang-Heon; Noh, Jae-Mun

2014-04-01

This study determined the dose of remifentanil to use during insertion of a Classic™ laryngeal mask airway (LMA, The Laryngeal Mask Co., Nicosia, Cyprus) in elderly patients during emergency airway management when combined with a single dose of propofol. Patients aged 65-80 years were enrolled. Anesthesia was induced with propofol 1 mg/kg, and then a blinded dose of remifentanil was infused over 30 s after confirming the patient's loss of consciousness. The dose of remifentanil was determined using Dixon's up-and-down method, starting at 0.5 µg/kg (a step size of 0.1 µg/kg). Insertion of the LMA was attempted 60 s after loss of consciousness. In total, 23 patients were recruited and the mean age ± standard deviation was 72 ± 3 years. The effective dose for successful LMA insertion in 50% of the patients (ED50) was 0.20 ± 0.05 µg/kg. No patient needed more than 0.3 µg/kg. Remifentanil 0.20 ± 0.05 µg/kg with propofol 1 mg/kg resulted in excellent LMA insertion in 50% of elderly patients without significant hemodynamic changes during emergency airway management.

When and why a colonoscopist should discontinue colonoscopy by himself?

PubMed

Gan, Tao; Yang, Jin-Lin; Wu, Jun-Chao; Wang, Yi-Ping; Yang, Li

2015-07-07

To investigate when and why a colonoscopist should discontinue incomplete colonoscopy by himself. In this cross-sectional study, 517 difficult colonoscope insertions (Grade C, Kudo's difficulty classification) screened from 37800 colonoscopy insertions were collected from April 2004 to June 2014 by three 4(th)-level (Kudo's classification) colonoscopists. The following common factors for the incomplete insertion were excluded: structural obstruction of the colon or rectum, insufficient colon cleansing, discontinuation due to patient's discomfort or pain, severe colon disease with a perforation risk (e.g., severe ischemic colonopathy). All the excluded patients were re-scheduled if permission was obtained from the patients whose intubation had failed. If the repeat intubations were still a failure because of the difficult operative techniques, those patients were also included in this study. The patient's age, sex, anesthesia and colonoscope type were recorded before colonoscopy. During the colonoscopic examination, the influencing factors of fixation, tortuosity, laxity and redundancy of the colon were assessed, and the insertion time (> 10 min or ≤ 10 min) were registered. The insertion time was analyzed by t-test, and other factors were analyzed by univariate and multivariate logistic regression. Three hundred and twenty-two (62.3%) of the 517 insertions were complete in the colonoscope insertion into the ileocecum, but 195 (37.7%) failed in the insertion. Fixation, tortuosity, laxity or redundancy occurred during the colonoscopic examination. Multivariate logistic regression analysis revealed that fixation (OR = 0.06, 95%CI: 0.03-0.16, P < 0.001) and tortuosity (OR = 0.04, 95%CI: 0.02-0.08, P < 0.001) were significantly related to the insertion into the ileocecum in the left hemicolon; multivariate logistic regression analysis also revealed that fixation (OR = 0.16, 95%CI: 0.06-0.39, P < 0.001), tortuosity (OR 0.23, 95%CI: 0.13-0.43, P < 0.001), redundancy (OR = 0.12, 95%CI: 0.05-0.26, P < 0.001) and sex (OR = 0.35, 95%CI: 0.20-0.63, P < 0.001) were significantly related to the insertion into the ileocecum in the right hemicolon. Prolonged insertion time (> 10 min) was an unfavorable factor for the insertion into the ileocecum. Colonoscopy should be discontinued if freedom of the colonoscope body's insertion and rotation is completely lost, and the insertion time is prolonged over 30 min.

Black pepper essential oil to enhance intravenous catheter insertion in patients with poor vein visibility: a controlled study.

PubMed

Kristiniak, Susan; Harpel, Jean; Breckenridge, Diane M; Buckle, Jane

2012-11-01

To evaluate the effect of topically applied black pepper essential oil on easing intravenous catheter insertion (IVC) in patients with no palpable or visible veins compared to a control group (standard nursing practice). Randomized, controlled study. One hundred twenty hospitalized patients, who were referred to a hospital vascular team because of difficulty in accessing veins for IVC insertion. Topical application of 20% essential oil of black pepper in aloe vera gel or standard nursing care (hot packs with or without vigorous tactile stimulation). Pre- and post-test vein visibility and/or palpability and number of attempts at IVC insertion. A higher percentage of patients achieved optimal scoring (vein score=2) or improved scoring (vein score of 1 or 2) to black pepper intervention than standard nursing care. The black pepper group also reduced the number of patients whose veins were still not visible or palpable after the intervention to nearly half that of the control group (p<0.05). The number of IVC attempts following black pepper was also half that of the control group. Topical application of black pepper is a viable and effective way to enhance vein visibility and palpability prior to intravenous insertion in patients with limited vein accessibility; it also improves ease of IVC insertion.

What is the yield of routine chest radiography following tube thoracostomy for trauma?

PubMed

Kong, Victor Y; Oosthuizen, George V; Clarke, Damian L

2015-01-01

Routine chest radiography (CXR) following tube thoracostomy (TT) is a standard practice in most trauma centres worldwide. Evidence supporting this routine practice is lacking and the actual yield is unknown. We performed a retrospective review of 1042 patients over a 4-year period who had a routine post-insertion CXR performed in accordance with current ATLS® recommendations. A total 1042 TTs were performed on 1004 patients. Ninety-one per cent of patients (913/1004) were males, and the median age for all patients was 24 years. Seventy-five per cent of all injuries (756/1004) were from penetrating trauma, and the remaining 25% (248/1004) were from blunt. The initial pathologies requiring TT were: haemopneumothorax: 34% (339/1042), haemothroax: 31% (314/1042), simple pneumothorax: 25% (256/1042), tension pneumothorax: 8% (77/1042) and open pneumothorax: 5% (54/1042). One hundred and three patients had TTs performed on clinical grounds alone without a pre-insertion CXR [Group A]. One hundred and ninety-one patients had a pre-insertion CXR but had persistent clinical concerns following insertion [Group B]. Seven hundred and ten patients had pre-insertion CXR but no clinical concerns following insertion [Group C]. Overall, 15% (152/1004) [9 from Group A, 111 from Group B and 32 from Group C] of all patients had their clinical management influenced as a direct result of the post-insertion CXR. Despite the widely accepted practice of routine CXR following tube thoracostomy, the yield is relatively low. In many cases, good clinical examination post tube insertion will provide warnings as to whether problems are likely to result. However, in the more rural setting, and in resource challenged environments, there is a relatively high yield from the CXR, which alters management. Further prospective studies are needed to establish or refute the role of the existing ATLS® guidelines in these specific environments. Copyright © 2014 Elsevier Ltd. All rights reserved.

An Assessment of Radiologically Inserted Transoral and Transgastric Gastroduodenal Stents to Treat Malignant Gastric Outlet Obstruction

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

Miller, Bethany H. T., E-mail: bmiller@doctors.org.uk; Griffiths, Ewen A., E-mail: Eagriffiths@doctors.org.uk; Pursnani, Kishore G., E-mail: Kish.Pursnani@lthtr.nhs.uk

2013-12-15

IntroductionSelf-expanding metallic stents (SEMS) are used to palliate malignant gastric outlet obstruction (GOO) and are useful in patients with limited life expectancy or severe medical comorbidity, which would preclude surgery. Stenting can be performed transorally or by a percutaneous transgastric technique. Our goal was to review the outcome of patients who underwent radiological SEMS insertion performed by a single consultant interventional radiologist. Methods: Patients were identified from a prospectively collected database held by one consultant radiologist. Data were retrieved from radiological reports, multidisciplinary team meetings, and the patients' case notes. Univariate survival analysis was performed. Results: Between December 2000 andmore » January 2011, 100 patients (63 males, 37 females) had 110 gastroduodenal stenting procedures. Median age was 73 (range 39-89) years. SEMS were inserted transorally (n = 66) or transgastrically (n = 44). Site of obstruction was the stomach (n = 37), duodenum (n = 50), gastric pull-up (n = 10), or gastroenterostomy (n = 13). Seven patients required biliary stents. Technical success was 86.4 %: 83.3 % for transoral insertion, 90.9 % for transgastric insertion. Eleven patients developed complications. Median GOO severity score: 1 pre-stenting, 2 post-stenting (p = 0.0001). Median survival was 54 (range 1-624) days. Post-stenting GOO severity score was predictive of survival (p = 0.0001). Conclusions: The technical success rate for insertion of palliative SEMS is high. Insertional technique can be tailored to the individual depending on the location of the tumor and whether it is possible to access the stomach percutaneously. Patients who have successful stenting and return to eating a soft/normal diet have a statistically significant increase in survival.« less

Unlocking Short Read Sequencing for Metagenomics

DOE PAGES

Rodrigue, Sébastien; Materna, Arne C.; Timberlake, Sonia C.; ...

2010-07-28

We describe an experimental and computational pipeline yielding millions of reads that can exceed 200 bp with quality scores approaching that of traditional Sanger sequencing. The method combines an automatable gel-less library construction step with paired-end sequencing on a short-read instrument. With appropriately sized library inserts, mate-pair sequences can overlap, and we describe the SHERA software package that joins them to form a longer composite read.

Consumer and health literacy: The need to better design tobacco-cessation product packaging, labels, and inserts.

PubMed

Weiss, Stephanie M; Smith-Simone, Stephanie Y

2010-03-01

Tobacco-cessation product packaging and instruction materials may not be appropriate for some smokers and may contribute to the underuse and misuse of evidence-based treatments. The dual goals of this project are to analyze literacy levels of Food and Drug Administration (FDA)-approved and non-approved tobacco-cessation product packaging, directions, and claims, and to identify and categorize claims found on product packaging. The Campaign for Tobacco Free Kids (CTFK) maintains the Quitting and Reducing Tobacco Use Inventory of Products (QuiTIP) database, which catalogs products marketed and sold to consumers to reduce or quit use of tobacco products. It also includes all medications approved by the FDA for tobacco cessation as well as a sample of non-approved products such as homeopathic, herbal, nutritional, or dietary supplements commonly marketed as either cessation aids or alternative tobacco/nicotine products. This paper assesses the reading levels required to understand product packaging, labeling, and instructions using the Simple Measure of Gobbledygook (SMOG) and identifies claims on the product package labels using standard qualitative methods. Key findings show that the average reading levels needed to understand instructions for both FDA-approved and non-approved cessation products are above the reading levels recommended to ensure maximum comprehension. Improving the packaging and directions of evidence-based tobacco-cessation products so that they are preferably at or below a fifth-grade reading level, along with using consumer-based design principles to develop packaging, may help smokers take advantage of and correctly use products that will greatly increase their chances of successful quitting. 2010 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

Reliability of CGA/LGA/HDI Package Board/Assembly (Final Report)

NASA Technical Reports Server (NTRS)

Ghaffaroam. Reza

2014-01-01

Package manufacturers are now offering commercial-off-the-shelf column grid array (COTS CGA) packaging technologies in high-reliability versions. Understanding the process and quality assurance (QA) indicators for reliability are important for low-risk insertion of these advanced electronics packages. The previous reports, released in January of 2012 and January of 2013, presented package test data, assembly information, and reliability evaluation by thermal cycling for CGA packages with 1752, 1517, 1509, and 1272 inputs/outputs (I/Os) and 1-mm pitch. It presented the thermal cycling (-55C either 100C or 125C) test results for up to 200 cycles. This report presents up to 500 thermal cycles with quality assurance and failure analysis evaluation represented by optical photomicrographs, 2D real time X-ray images, dye-and-pry photomicrographs, and optical/scanning electron Microscopy (SEM) cross-sectional images. The report also presents assembly challenge using reflowing by either vapor phase or rework station of CGA and land grid array (LGA) versions of three high I/O packages both ceramic and plastic configuration. A new test vehicle was designed having high density interconnect (HDI) printed circuit board (PCB) with microvia-in-pad to accommodate both LGA packages as well as a large number of fine pitch ball grid arrays (BGAs). The LGAs either were assembled onto HDI PCB as an LGA or were solder paste print and reflow first to form solder dome on pads before assembly. Both plastic BGAs with 1156 I/O and ceramic LGAs were assembled. It also presented the X-ray inspection results as well as failures due to 200 thermal cycles. Lessons learned on assembly of ceramic LGAs are also presented.

Variation in Prescribing Patterns and Therapeutic Drug Monitoring of Intravenous Busulfan in Pediatric Hematopoietic Cell Transplant Recipients

PubMed Central

McCune, Jeannine S.; Baker, K. Scott; Blough, David K.; Gamis, Alan; Bemer, Meagan J.; Kelton-Rehkopf, Megan C.; Winter, Laura; Barrett, Jeffrey S.

2016-01-01

Personalizing intravenous (IV) busulfan doses in children using therapeutic drug monitoring (TDM) is an integral component of hematopoietic cell transplant. The authors sought to characterize initial dosing and TDM of IV busulfan, along with factors associated with busulfan clearance, in 729 children who underwent busulfan TDM from December 2005 to December 2008. The initial IV busulfan dose in children weighing ≤12 kg ranged 4.8-fold, with only 19% prescribed the package insert dose of 1.1 mg/kg. In those children weighing >12 kg, the initial dose ranged 5.4-fold, and 79% were prescribed the package insert dose. The initial busulfan dose achieved the target exposure in only 24.3% of children. A wide range of busulfan exposures were targeted for children with the same disease (eg, 39 target busulfan exposures for the 264 children diagnosed with acute myeloid leukemia). Considerable heterogeneity exists regarding when TDM is conducted and the number of pharmacokinetic samples obtained. Busulfan clearance varied by age and dosing frequency but not by underlying disease. The authors’ group is currently evaluating how using population pharmacokinetics to optimize initial busulfan dose and TDM (eg, limited sampling schedule in conjunction with maximum a posteriori Bayesian estimation) may affect clinical outcomes in children. PMID:23444282

Comparison of the analgesic effects of oral tramadol and naproxen sodium on pain relief during IUD insertion.

PubMed

Karabayirli, Safinaz; Ayrim, Aylin Aker; Muslu, Bunyamin

2012-01-01

To compare the analgesic efficacy of oral tramadol and naproxen sodium on pain during insertion of an intrauterine device (IUD). Randomized, double-blinded, clinical trial (Canadian Task Force classification I). University-affiliated hospital. Single-center. One hundred three patients scheduled for insertion of an IUD. Patients were randomly assigned to receive oral tramadol 50 mg capsules (n = 35) or naproxen sodium 550 mg tablets (n = 34) or placebo (n = 34) 1 hour before insertion of the IUD. After insertion of the IUD, pain intensity was evaluated using a visual analog scale (VAS, 0-10). Adverse effects, patient satisfaction with the medication, and preference for using it during future insertions were also recorded. The VAS scores were significantly different during IUD insertion among the 3 groups (p = .001). Pain scores in the tramadol group were significantly lower than in the naproxen group (p = .003), and the scores in the naproxen group was significantly lower than in the control group (p = .001). Patient satisfaction with the medication and preference for its future use were significantly lower in the control group than in the other 2 groups (p = .001). Prophylactic analgesia using 50 mg tramadol and 550 mg naproxen, delivered orally, can be used to relieve pain during IUD insertion. However, tramadol capsules were found to be more effective than naproxen tablets. Copyright © 2012 AAGL. Published by Elsevier Inc. All rights reserved.

A small and efficient dimerization/packaging signal of rat VL30 RNA and its use in murine leukemia virus-VL30-derived vectors for gene transfer.

PubMed Central

Torrent, C; Gabus, C; Darlix, J L

1994-01-01

Retroviral genomes consist of two identical RNA molecules associated at their 5' ends by the dimer linkage structure located in the packaging element (Psi or E) necessary for RNA dimerization in vitro and packaging in vivo. In murine leukemia virus (MLV)-derived vectors designed for gene transfer, the Psi + sequence of 600 nucleotides directs the packaging of recombinant RNAs into MLV virions produced by helper cells. By using in vitro RNA dimerization as a screening system, a sequence of rat VL30 RNA located next to the 5' end of the Harvey mouse sarcoma virus genome and as small as 67 nucleotides was found to form stable dimeric RNA. In addition, a purine-rich sequence located at the 5' end of this VL30 RNA seems to be critical for RNA dimerization. When this VL30 element was extended by 107 nucleotides at its 3' end and inserted into an MLV-derived vector lacking MLV Psi +, it directed the efficient encapsidation of recombinant RNAs into MLV virions. Because this VL30 packaging signal is smaller and more efficient in packaging recombinant RNAs than the MLV Psi + and does not contain gag or glyco-gag coding sequences, its use in MLV-derived vectors should render even more unlikely recombinations which could generate replication-competent viruses. Therefore, utilization of the rat VL30 packaging sequence should improve the biological safety of MLV vectors for human gene transfer. Images PMID:8289369

Impact of endoscopic stent insertion on detection of viable circulating tumor cells from obstructive colorectal cancer

PubMed Central

Yamashita, Shinya; Tanemura, Masahiro; Sawada, Genta; Moon, Jeongho; Shimizu, Yosuke; Yamaguchi, Toshiki; Kuwai, Toshio; Urata, Yasuo; Kuraoka, Kazuya; Hatanaka, Nobutaka; Yamashita, Yoshinori; Taniyama, Kiyomi

2018-01-01

The placement of a self-expanding metallic stent (SEMS) in obstructive colorectal cancer (OCRC) is acknowledged to be a safe and effective procedure for the relief of obstruction. However, there is concern that shear forces acting on the tumor during stent expansion may release cancer cells into the circulation, resulting in a poor prognosis. The aim of the present study was to determine whether colonic stent insertion increases viable circulating tumor cells (v-CTCs). A telomerase-specific replication-selective adenovirus-expressing GFP (TelomeScanF35) detection system was used to detect v-CTCs in 8 OCRC patients with a SEMS before and after stent insertion and after surgical resection. In 7 patients, a SEMS was inserted as a bridge to surgery (BTS), and in one patient, a SEMS was inserted for palliation. Surgical resection (R0) was performed in 7 patients. Four patients had no v-CTCs before SEMS placement, two of four measurable patients had an increased number of v-CTCs after SEMS placement (1–3 v-CTCs), and one of two patients with increased v-CTCs developed distant lymphatic metastasis despite curative resection. Four patients had v-CTCs (1–19 cells) before SEMS placement, and two of these four patients had an increase in the number of v-CTCs (20–21 cells) after SEMS placement, while one of the four patients died early with distant metastasis. The present study demonstrated that endoscopic stent insertion for OCRC may result in tumor cell dissemination into the peripheral circulation and may induce distant metastases. PMID:29391884

Impact of endoscopic stent insertion on detection of viable circulating tumor cells from obstructive colorectal cancer.

PubMed

Yamashita, Shinya; Tanemura, Masahiro; Sawada, Genta; Moon, Jeongho; Shimizu, Yosuke; Yamaguchi, Toshiki; Kuwai, Toshio; Urata, Yasuo; Kuraoka, Kazuya; Hatanaka, Nobutaka; Yamashita, Yoshinori; Taniyama, Kiyomi

2018-01-01

The placement of a self-expanding metallic stent (SEMS) in obstructive colorectal cancer (OCRC) is acknowledged to be a safe and effective procedure for the relief of obstruction. However, there is concern that shear forces acting on the tumor during stent expansion may release cancer cells into the circulation, resulting in a poor prognosis. The aim of the present study was to determine whether colonic stent insertion increases viable circulating tumor cells (v-CTCs). A telomerase-specific replication-selective adenovirus-expressing GFP (TelomeScanF35) detection system was used to detect v-CTCs in 8 OCRC patients with a SEMS before and after stent insertion and after surgical resection. In 7 patients, a SEMS was inserted as a bridge to surgery (BTS), and in one patient, a SEMS was inserted for palliation. Surgical resection (R0) was performed in 7 patients. Four patients had no v-CTCs before SEMS placement, two of four measurable patients had an increased number of v-CTCs after SEMS placement (1-3 v-CTCs), and one of two patients with increased v-CTCs developed distant lymphatic metastasis despite curative resection. Four patients had v-CTCs (1-19 cells) before SEMS placement, and two of these four patients had an increase in the number of v-CTCs (20-21 cells) after SEMS placement, while one of the four patients died early with distant metastasis. The present study demonstrated that endoscopic stent insertion for OCRC may result in tumor cell dissemination into the peripheral circulation and may induce distant metastases.

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

Han, Young-Min; Kim, Chan-Young; Yang, Doo-Hyun

Purpose. To evaluate the feasibility and effectiveness of feeding tube insertion and enteral feeding for the treatment of postoperative gastrointestinal anastomotic obstruction and leakage. Materials and Methods. From June 1999 to June 2002, thirty-four cases of postoperative gastrointestinal anastomotic obstruction and leakage after surgery for gastric carcinoma were treated by insertion of a feeding tube under fluoroscopic guidance. Twenty-one patients were male and 13 were female. The patients' ages ranged from 39 to 74 years (mean age: 61 years). All the patients experienced vomiting, and 15 patients had anastomotic site or duodenal stump leakage. We evaluated the feasibility of feedingmore » tube insertion for enteral feeding to improve the obstruction and facilitate leakage site closure, and the patients' nutritional benefit was also evaluated by checking the serum albumin level between pre- and post-enteral feeding via the feeding tube.Results. Thirty-two patients (94%) were successfully managed by feeding tube insertion, but the remaining two were not managed, and this was due to severe angulations at the anastomotic site. The procedure times for feeding tube insertion ranged from 15 to 60 minutes (mean time: 45 minutes). Twenty-eight patients experienced symptomatic relief of gastrointestinal obstruction, and they were able to resume a normal regular diet after feeding tube removal. Three patients underwent stent insertion due to recurrent symptoms, and one patient underwent jejunostomy feeding due to the presence of a persistent leakage site. Eleven patients achieved leakage site closure after enteral feeding via a feeding tube. The serum albumin level was significant, increased from pre-enteral feeding (2.65 {+-} 0.37 g/dL) to the post-enteral feeding (3.64 {+-} 0.58 g/dL) via the feeding tube (p < 0.001). The duration of follow-up ranged from one to 53 months (mean: 23 months). Conclusion. The insertion of a feeding tube for enteral feeding under fluoroscopic guidance is safe, and it provides effective relief from gastrointestinal anastomotic site obstruction and leakage after gastric surgery. Moreover, our findings indicate that feeding tube insertion for enteral feeding may be used as the primary procedure to treat postoperative anastomotic obstruction and leakage.« less

Sensitivity and specificity of CT scanning for determining the number of internally concealed packages in 'body-packers'.

PubMed

Asha, Stephen Edward; Higham, Matthew; Child, Peter

2015-05-01

If package counts on abdominal CTs of body-packers were known to be accurate, follow-up CTs could be avoided. The objective was to determine the accuracy of CT for the number of concealed packages in body-packers, and the reliability of package counts reported by body-packers who admit to concealing drugs. Suspected body-packers were identified from the emergency departments (ED) database. The medical record and radiology reports were reviewed for package counts determined by CT, patient-reported and physically retrieved. The last method was used as the reference standard. Sensitivity, specificity, positive predictive values (PPV) and negative predictive values (NPV) were calculated for CT package count accuracy. Reliability of patient-reported package counts was assessed using Pearson's correlation coefficient. There were 50 confirmed body-packers on whom 104 CT scans were performed. Data for the index and reference tests were available for 84 scans. The sensitivity, specificity, PPV and NPV for CT package count were 63% (95% CI 46% to 77%), 82% (95% CI 67% to 92%), 76% (95% CI 58% to 89%) and 71% (95% CI 56% to 83%) respectively. For CTs with a package count<15, the sensitivity, specificity, PPV and NPV for CT package count were 96% (95% CI 80% to 99%), 95% (95% CI 82% to 99%), 93% (95% CI 76% to 99%) and 97% (95% CI 86% to 100%), respectively. Correlation between patient-reported package counts and the number of packages retrieved was high (r=0.90, p<0.001, R2=81%). The accuracy of CT for determining the number of concealed packages is poor, although when applied to patients with few concealed packages accuracy is high and is useful as a rule-out test. Among patients who have admitted to drug concealment, the number of packages reported to be concealed is reliable. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Palliative treatment of inoperable patients with carcinoma of the cardia region.

PubMed

Seifert, E; Reinhard, A; Lütke, A; Gail, K

1983-02-01

Endoscopic palliative treatment of inoperable patients with carcinoma of the cardia region is superior to surgical procedures that allow the feeding of patients. After dilating the malignant stenosis with an Eder-Puestow dilator, a Celestin or Atkinson tube is inserted endoscopically by means of the Nottingham introducer. In 25 of 26 patients the inserted tube functioned well until the death of the patient for an average of 109 days. Six patients are still alive and one patient has had the tube for almost 3 years. Of the 19 patients who died, 18 retained the tube until they died. The complication rate of the procedure was 11.5% with a 3.8% mortality related to tube insertion.

Safety and efficacy of self-expandable metal stents for obstructive proximal and distal large bowel cancer.

PubMed

Mitra, V; Hu, M; Majumdar, D; Krishnan, V; Chaudhury, B; Hancock, J; Dwarakanath, D

2017-03-01

Self-expandable metal stents are often used to treat obstructive large bowel cancers. This study assessed the safety and efficacy of colonic stent insertion carried out in a district general hospital. Methods A retrospective review was carried out between 1 January 2007 and 28 February 2014 to identify patients who underwent stent insertion for malignant colorectal obstruction. Results Seventy-five patients (median age 75.2 years, 70.6% male) with primary colorectal cancer underwent stent insertion - 53 underwent semi-elective self-expanded metal stent insertion (for subacute bowel obstruction) and 22 had emergency stent inserted (for acute bowel obstruction). The majority (88%) had self-expanded metal stents inserted for palliation. Technical and clinical success rates were 98.7% and 91.2%, respectively. One patient had stent-related perforation; there was no procedure-related mortality. Conclusion This study shows that self-expanded metal stent insertion in malignant colorectal obstruction is safe and effective and can be successfully delivered in a district general hospital with high technical and clinical success rates.

Risk of venous thromboembolism in hospitalized patients with peripherally inserted central catheters.

PubMed

Lobo, Bob L; Vaidean, Georgeta; Broyles, Joyce; Reaves, Anne B; Shorr, Ronald I

2009-09-01

Peripherally inserted central catheters (PICC) are increasingly used in hospitalized patients. The benefit can be offset by complications such as upper extremity deep vein thrombosis (UEDVT). Retrospective study of patients who received a PICC while hospitalized at the Methodist University Hospital (MUH) in Memphis, TN. All adult consecutive patients who had PICCs inserted during the study period and who did not have a UEDVT at the time of PICC insertion were included in the study. A UEDVT was defined as a symptomatic event in the ipsilateral extremity, leading to the performance of duplex ultrasonography, which confirmed the diagnosis of UEDVT. Pulmonary embolism (PE) was defined as a symptomatic event prompting the performance of ventilation-perfusion lung scan or spiral computed tomography (CT). Among 777 patients, 38 patients experienced 1 or more venous thromboembolisms (VTEs), yielding an incidence of 4.89%. A total of 7444 PICC-days were recorded for 777 patients. This yields a rate of 5.10 VTEs/1000 PICC-days. Compared to patients whose PICC was inserted in the SVC, patients whose PICC was in another location had an increased risk (odds ratio = 2.61 [95% CI = 1.28-5.35]) of VTE. PICC related VTE was significantly more common among patients with a past history of VTE (odds ratio = 10.83 [95% CI = 4.89-23.95]). About 5% of patients undergoing PICC placement in acute care hospitals will develop thromboembolic complications. Thromboembolic complications were especially common among persons with a past history of VTE. Catheter tip location at the time of insertion may be an important modifiable risk factor. Copyright 2009 Society of Hospital Medicine.

Endoscopic biliary stent insertion through specialized duodenal stent for combined malignant biliary and duodenal obstruction facilitated by stent or PTBD guidance.

PubMed

Lee, Jong Jin; Hyun, Jong Jin; Choe, Jung Wan; Lee, Dong-Won; Kim, Seung Young; Jung, Sung Woo; Jung, Young Kul; Koo, Ja Seol; Yim, Hyung Joon; Lee, Sang Woo

2017-11-01

Endoscopic stenting for combined malignant biliary and duodenal obstruction is technically demanding. However, this procedure can be facilitated when there is guidance from previously inserted stent or PTBD tube. This study aimed to evaluate the feasibility and clinical success rate of endoscopic placement of biliary self-expandable metal stent (SEMS) through duodenal SEMS in patients with combined biliary and duodenal obstruction due to inoperable or metastatic periampullary malignancy. A total of 12 patients with combined malignant biliary and duodenal stricture underwent insertion of biliary SEMS through the mesh of specialized duodenal SEMS from July 2012 to October 2016. Technical and clinical success rate, adverse events and survival after completion of SEMS insertion were evaluated. The duodenal strictures were located in the first portion of the duodenum in four patients (Type I), in the second portion in three patients (Type II), and in the third portion in five patients (Type III). Technical success rate of combined metallic stenting was 91.7%. Insertion of biliary SEMS was guided by previously inserted biliary SEMS in nine patients, plastic stent in one patient, and PTBD in two patients. Clinical success rate was 90.9%. There were no early adverse events after the procedure. Mean survival period after combined metallic stenting was 91.9 days (range: 15-245 days). Endoscopic placement of biliary SEMS through duodenal SEMS is feasible with high success rates and relatively easy when there is guidance. This method can be a good alternative for palliation in patients with combined biliary and duodenal obstruction.

The role of assessment packages for diagnostic consultations: A conversation analytic perspective.

PubMed

Rossen, Camilla B; Buus, Niels; Stenager, Egon; Stenager, Elsebeth

2015-05-01

This article reports a conversation analysis of assessment package consultations. Healthcare delivery packages belong to a highly structured mode of healthcare delivery, in which specific courses of healthcare interventions related to assessment and treatment are predefined, both as to timing and content. Assessment packages are widely used in an increasing number of medical specialities; however, there is a lack of knowledge about how packaged assessment influences the interaction between doctor and patient. In this study, we investigate the final consultation in assessment packages, which is when the final clarification of the patient's symptoms takes place. The primary data of the study were eight audio recordings of consultations, and the secondary data were ethnographic field descriptions. In most consultations, packaged assessment was a resource as it provided fast and efficient clarification. In most cases, clarification was treated as good news since it either confirmed the absence of a serious disease or resulted in a diagnosis leading to relevant treatment offers. However, in some cases, clarification was not perceived as good news. This was the case in consultations with patients whose goal was to leave the consultation with clarification in the form of a definite diagnosis, but who were not offered such clarification. These patients negotiated the outcome of the consultation by applying implicit and explicit pressure, which induced the doctors to disregard the boundaries of the package and offer the patient more tests. The study highlights some of the problems related to introducing narrow, specialized package assessment. © The Author(s) 2014.

Surface acoustic wave resonators

NASA Astrophysics Data System (ADS)

Avitabile, Gianfranco; Roselli, Luca; Atzeni, Carlo; Manes, Gianfranco

1991-10-01

The development of surface acoustic wave (SAW) resonators is reviewed with attention given to the design of a simulation package for CAD-assisted SAW resonator design. Basic design configurations and operation parameters are set forth for the SAW resonators including the phase of the reflection factor, evaluation of the stopband center frequency, stopband width, and the free propagation speed. The use of synchronous designs is shown to reduce device sensitivity to variations in the technological process but generate higher insertion losses. The existence of transverse modes and propagation losses is shown to affect the rejection of spurious modes and the achievement of low insertion losses. Several SAW resonators are designed and fabricated with the CAD process, and the resonators in the VHF-UHF bands perform in a manner predicted by simulated results.

Clinical outcomes of VNS therapy with AspireSR® (including cardiac-based seizure detection) at a large complex epilepsy and surgery centre.

PubMed

Hamilton, Preci; Soryal, Imad; Dhahri, Prince; Wimalachandra, Welege; Leat, Anna; Hughes, Denise; Toghill, Nicole; Hodson, James; Sawlani, Vijay; Hayton, Tom; Samarasekera, Shanika; Bagary, Manny; McCorry, Dougall; Chelvarajah, Ramesh

2018-05-01

To compare the efficacy of AspireSR ® to preceding VNS battery models for battery replacements, and to determine the efficacy of the AspireSR ® for new implants. Data were collected retrospectively from patients with epilepsy who had VNS AspireSR ® implanted over a three-year period between June 2014 and June 2017 by a single surgeon. Cases were divided into two cohorts, those in whom the VNS was a new insertion, and those in whom the VNS battery was changed from a previous model to AspireSR ® . Within each group, the seizure burden was compared between the periods before and after insertion of AspireSR ® . Fifty-one patients with a newly inserted AspireSR ® VNS model had a significant reduction in seizure frequency (p < 0.001), with 59% (n = 30) reporting ≥50% reduction. Of the 62 patients who had an existing VNS, 53% (n = 33) reported ≥50% reduction in seizure burden when the original VNS was inserted. After the battery was changed to the AspireSR ® , 71% (n = 44) reported a further reduction of ≥50% in their seizure burden. The size of this reduction was at least as large as that resulting from the insertion of their existing VNS in 98% (61/62) of patients. The results suggest that approximately 70% of patients with existing VNS insertions could have significant additional benefit from cardiac based seizure detection and closed loop stimulation from the AspireSR ® device. For new insertions, the AspireSR ® device has efficacy in 59% of patients. The 'rule of thirds' used in counseling patients may need to be modified accordingly. Crown Copyright © 2018. Published by Elsevier Ltd. All rights reserved.

The insertion of self expanding metal stents with flexible bronchoscopy under sedation for malignant tracheobronchial stenosis: a single-center retrospective analysis.

PubMed

McGrath, Emmet E; Warriner, David; Anderson, Paul

2012-02-01

To describe a 10-year experience of inserting Ultraflex™ self-expanding metal stents (SEMS) under sedation using flexible bronchoscopy for the treatment of malignant tracheobronchial stenosis in a tertiary referral centre. Medical notes were retrospectively reviewed for all patients who underwent SEMS insertion between 1999 and 2009. A data analysis of 68 patients who had Ultraflex™ SEMS inserted under sedation was completed. Thirty three males and 35 females with a mean age of 67.9 years (range 35-94) presented with features including dyspnea/respiratory distress (39 patients), stridor (16 patients) and hemoptysis/dyspnea (13 patients). Etiology of stenosis included lung cancer (46 patients) esophageal cancer (14 patients) and other malignancies (8 patients). Mean dose of midazolam administered was 5mg (range 0-10mg). The trachea was the most common site of stent insertion followed by the right and left main bronchus, respectively. Adjuvant laser therapy was applied at some stage in 31% of all cases, and chemotherapy and/or radiotherapy was administered to at least 64% of patients with malignant disease. Hemoptysis and stent migration were the most frequent complications (5 and 4 patients, respectively). The mean survival time of stented non-small cell lung cancer (NSCLC) patients was 214 days (range 5-1233) and that of esophageal malignancy was 70 days (range 12-249). Mean pack-year history of individuals with lung cancer requiring stent insertion was 37 (range 2-100). Ultraflex stents offer a safe and effective therapy for patients who are inoperable or unresectable that otherwise would have no alternative therapy. It has an immediate beneficial effect upon patients, not only through symptom relief but, in some, through prolongation of life. Survival data is no worse than other studies using different varieties of stents and insertion techniques indicating its longer-term efficacy. Moreover, this report highlights the feasibility of performing this procedure successfully in a respiratory unit, without the need for general anesthesia. Copyright © 2011 SEPAR. Published by Elsevier Espana. All rights reserved.

Can insertion length for a double-lumen endobronchial tube be predicted?

PubMed

Dyer, R A; Heijke, S A; Russell, W J; Bloch, M B; James, M F

2000-12-01

It has been suggested that the appropriate length of insertion for double-lumen tubes can be estimated by external measurement. This study examined the accuracy of external measurement in estimating the actual length of insertion required in 130 patients. It also examined the relationship between the length inserted and the patient's height in 126 patients and their weight in 125 patients. Although there was a fair correlation between the measured external length and the final inserted length (r = 0.61), the 95% confidence intervals of slope and intercept allowed a large variation and the prediction was too wide to be clinically useful. Height was reasonably well correlated with the final length (r = 0.51) but an equally wide 95% confidence interval rendered it of little clinical value. There was no correlation between weight and final tube length. It is concluded that external measurement alone is not adequate to predict a clinically acceptable position of the double-lumen tube.

KSC-97PC1277

NASA Image and Video Library

1997-08-22

In the Payload Hazardous Servicing Facility (PHSF), Dan Maynard, a Jet Propulsion Laboratory technician, inserts the Digital Video Disk (DVD) into a shallow cavity between two pieces of aluminum that will protect it from micrometeoroid impacts. The package will be mounted to the side of the two-story-tall spacecraft beneath a pallet carrying cameras and other space instruments that will be used to study the Saturnian system. A specially designed, multicolored patch of thermal blanket material will be installed over the disk package. Along with the spacecraft, the disk will reside in Saturn's orbit centuries after the primary mission is completed in July 2008. The Cassini mission is managed for NASA's Office of Space Science, Washington, D.C., by the Jet Propulsion Laboratory, a division of the California Institute of Technology

Field Level Computer Exploitation Package

DTIC Science & Technology

2007-03-01

to take advantage of the data retrieved from the computer. Major Barge explained that if a tool could be designed that nearly anyone could use...the study of network forensics. This has become a necessity because of the constantly growing eCommerce industry and the stiff competition between...Security. One big advantage that Insert has is the fact that it is quite small compared to most bootable CDs. At only 60 megabytes it can be burned

Complications of ventilation tube insertion in children with and without cleft palate: a nested case-control comparison.

PubMed

Smillie, Ian; Robertson, Sophie; Yule, Anna; Wynne, David M; Russell, Craig J H

2014-10-01

Optimizing hearing in patients with cleft lip and/or palate (CLP) by early recognition and management of otitis media with effusion is essential for speech development. Some evidence has suggested higher complication rates from ventilation tube (VT) insertion in patients with CLP and has led to a trend not to treat these patients surgically. However, studies have failed to match comparison groups for age and sex. To compare complication rates from VT insertion in pediatric patients with and without CLP. The study used a nested case-control design to evaluate 60 pediatric patients with CLP who underwent VT insertion at a children's hospital. The control group of age- and sex-matched patients was selected from a database of 2943 VT insertions. All patients were administered general anesthesia and underwent VT insertion by a pediatric otorhinolaryngology (ENT) team. The primary outcomes were numbers of otorrhea complications. Secondarily, rates of attendance at an ENT clinic specifically for complications were evaluated. Finally, numbers of complications other than otorrhea were assessed but not statistically analyzed owing to the varied types and low numbers in each group. The control cohort had 151 documented cases of otorrhea compared with 121 in the CLP group (ratio 1.25:1); the difference between groups was not statistically significant (P = .52). There was no significant difference in mean ENT clinic visits per patient for complications between groups (0.80 in the CLP group, 0.78 for controls) (P = .66). Regarding complications other than otorrhea, the control group reported more than the CLP group (43 vs 25; ratio, 1.7:1). Complication rates of VT placement among patients with CLP were not higher than those among patients without CLP. Therefore, treatment with VT insertion should be administered to patients with CLP under the same guidelines as for those without CLP. Indeed, there could be an argument for a shift in practice toward more aggressive treatment of patients with CLP, who are already vulnerable to speech and social developmental delay.

Fifteen years experience of penile prosthesis insertion.

PubMed

Burns-Cox, N; Burston, A; Gingell, J C

1997-12-01

To review the outcome and patient satisfaction of penile prosthesis insertion over a 15 y period. We reviewed the notes of 172 patients who underwent penile prosthesis insertion between January 1980 and May 1995. From the notes information was determined on age of the patient, type of prosthesis, surgical approach and length of stay. Also noted were risk factors for erectile dysfunction and the aetiology. Twenty patients were known to have died or moved away. To assess the impact the operation had on quality of life, 152 questionnaires were sent of which 103 were returned (67%). The questionnaire gained information about sexual activity, before and after the operation and the overall satisfaction of the patient and his partner and whether they felt the operation was a success. Overall 149 patients were known to have had malleable prostheses inserted and 23 had inflatables. The commonest organic groups were vascular disease, diabetes and Peyronies disease. Fifteen patients had two procedures. Four patients required revision of the prosthesis due to erosion, and there was one death due to pulmonary embolism. One hundred and three completed questionnaires have been returned to date the median time since operation was 4 y, the range being six months to 16 y and 78% thought the operation was a success. The insertion of malleable prostheses is associated with low complication rates, good patient satisfaction and improved quality of life for the couple. Concealment was not a major problem.

Management of occluded self-expanding biliary metal stents in malignant biliary disease.

PubMed

Nennstiel, Simon; Tschurtschenthaler, Isolde; Neu, Bruno; Algül, Hana; Bajbouj, Monther; Schmid, Roland M; von Delius, Stefan; Weber, Andreas

2018-02-01

Occlusion of self-expanding metal stents (SEMS) in malignant biliary obstruction occurs in up to 40% of patients. This study aimed to compare the different techniques to resolve stent occlusion in our collective of patients. Patients with malignant biliary obstruction and occlusion of biliary metal stent at a tertiary referral endoscopic center were retrospectively identified between April 1, 1994 and May 31, 2014. The clinical records were further analyzed regarding the characteristics of patients, malignant strictures, SEMS, management strategies, stent patency, subsequent interventions, survival time and case charges. A total of 108 patients with biliary metal stent occlusion were identified. Seventy-nine of these patients were eligible for further analysis. Favored management was plastic stent insertion in 73.4% patients. Second SEMS were inserted in 12.7% patients. Percutaneous transhepatic biliary drainage and mechanical cleansing were conducted in a minority of patients. Further analysis showed no statistically significant difference in median overall secondary stent patency (88 vs. 143 days, P = 0.069), median survival time (95 vs. 192 days, P = 0.116), median subsequent intervention rate (53.4% vs. 40.0%, P = 0.501) and median case charge (€5145 vs. €3473, P = 0.803) for the treatment with a second metal stent insertion compared to plastic stent insertion. In patients with survival time of more than three months, significantly more patients treated with plastic stents needed re-interventions than patients treated with second SEMS (93.3% vs. 57.1%, P = 0.037). In malignant biliary strictures, both plastic and metal stent insertions are feasible strategies for the treatment of occluded SEMS. Our data suggest that in palliative biliary stenting, patients especially those with longer expected survival might benefit from second SEMS insertion. Careful patient selection is important to ensure a proper decision for either management strategy. Copyright © 2018 First Affiliated Hospital, Zhejiang University School of Medicine in China. Published by Elsevier B.V. All rights reserved.

Drug packaging in 2013: small changes would reap big benefits.

PubMed

2014-05-01

Drug packaging is important both in protecting and informing patients. Some improvements were made in 2013, but many of the products examined by Prescrire still had poor-quality or even dangerous packaging. Problem packaging is a major concern for patients who are more vulnerable to adverse effects, particularly children and pregnant women. Several problems were noted with products intended for self-medication (umbrella brands), oral solutions sold with dosing devices, and injectable drugs. Looking back at 20 years of Red Cards that Prescrire has issued to products with dangerous packaging reveals several improvements, but too many dangers persist. Urgent action needs to be taken by regulatory agencies and drug companies: patient leaflets must be more explicit with regard to adverse effects, especially those of nonsteroidal anti-inflammatory drugs during pregnancy; accidental ingestion by children must be prevented; and companies must design safer dosing devices. Healthcare professionals and patients must remain vigilant and report all packaging issues to the relevant authorities.

Percutaneous insertion of peritoneal dialysis catheters using ultrasound and fluoroscopic guidance: A single centre experience and review of literature.

PubMed

De Boo, Diederick W; Mott, Nigel; Tregaskis, Peter; Quach, Trung; Menahem, Solomon; Walker, Rowan G; Koukounaras, Jim

2015-12-01

Various methods of peritoneal dialysis (PD) catheter insertion are available. The purpose of this study was to evaluate a percutaneous insertion technique using ultrasound (US) and fluoroscopy performed under conscious sedation and as day case procedure. Data of 87 percutaneous inserted dialysis catheters were prospectively collected, including patients' age, gender, body mass index, history of previous abdominal surgery and cause of end stage renal failure. Length of hospital stay, early complications and time to first use were also recorded. Institutional review board approval was obtained. A 100% technical success rate was observed. Early complications included bleeding (n = 3), catheter dysfunction (n = 6), exit site infection (n = 1) and exit site leakage (n = 1). All cases of catheter dysfunction and one case of bleeding required surgical revision. Median time of follow-up was 18 months (range 3-35), and median time from insertion to first use was days 14 (1-47). Of the 82 patients who started dialysis, 20 (23%) ceased PD at some stage during follow-up. Most frequently encountered reasons include deteriorating patient cognitive or functional status (n = 5), successful transplant kidney (n = 4) and pleuro-peritoneal fistula (n = 4). Sixty-two (71%) PD catheter insertions were performed as day case. The remaining insertions were performed on patients already admitted to the hospital. Percutaneous insertion of dialysis catheter using US and fluoroscopy is not only safe but can be performed as day case procedure in most patients, even with a medical history of abdominal surgery and/or obesity. © 2015 The Royal Australian and New Zealand College of Radiologists.

Comparison of catheter-related large vein thrombosis in centrally inserted versus peripherally inserted central venous lines in the neurological intensive care unit.

PubMed

Wilson, Thomas J; Stetler, William R; Fletcher, Jeffrey J

2013-07-01

To compare cumulative complication rates of peripherally (PICC) and centrally (CICVC) inserted central venous catheters, including catheter-related large vein thrombosis (CRLVT), central line-associated bloodstream infection (CLABSI), and line insertion-related complications in neurological intensive care patients. Retrospective cohort study and detailed chart review for 431 consecutive PICCs and 141 CICVCs placed in patients under neurological intensive care from March 2008 through February 2010. Cumulative incidence of CRLVT, CLABSI, and line insertion-related complications were compared between PICC and CICVC groups. Risk factors for CRLVT including mannitol therapy during dwell time, previous history of venous thromboembolism, surgery longer than 1h during dwell time, and line placement in a paretic arm were also compared between groups. During the study period, 431 unique PICCs were placed with cumulative incidence of symptomatic thrombosis of 8.4%, CLABSI 2.8%, and line insertion-related complications 0.0%. During the same period, 141 unique CICVCs were placed with cumulative incidence of symptomatic thrombosis of 1.4%, CLABSI 1.4%, and line insertion-related complications 0.7%. There was a statistically significant difference in CRLVT with no difference in CLABSI or line insertion-related complications. In neurological critical care patients, CICVCs appear to have a better risk profile compared to PICCs, with a decreased risk of CRLVT. As use of PICCs in critical care patients increases, a prospective randomized trial comparing PICCs and CICVCs in neurological critical care patients is necessary to assist in choosing the appropriate catheter and to minimize risks of morbidity and mortality associated with central venous access. Copyright © 2012 Elsevier B.V. All rights reserved.

Exploratory Application of Augmented Reality/Mixed Reality Devices for Acute Care Procedure Training.

PubMed

Kobayashi, Leo; Zhang, Xiao Chi; Collins, Scott A; Karim, Naz; Merck, Derek L

2018-01-01

Augmented reality (AR), mixed reality (MR), and virtual reality devices are enabling technologies that may facilitate effective communication in healthcare between those with information and knowledge (clinician/specialist; expert; educator) and those seeking understanding and insight (patient/family; non-expert; learner). Investigators initiated an exploratory program to enable the study of AR/MR use-cases in acute care clinical and instructional settings. Academic clinician educators, computer scientists, and diagnostic imaging specialists conducted a proof-of-concept project to 1) implement a core holoimaging pipeline infrastructure and open-access repository at the study institution, and 2) use novel AR/MR techniques on off-the-shelf devices with holoimages generated by the infrastructure to demonstrate their potential role in the instructive communication of complex medical information. The study team successfully developed a medical holoimaging infrastructure methodology to identify, retrieve, and manipulate real patients' de-identified computed tomography and magnetic resonance imagesets for rendering, packaging, transfer, and display of modular holoimages onto AR/MR headset devices and connected displays. Holoimages containing key segmentations of cervical and thoracic anatomic structures and pathology were overlaid and registered onto physical task trainers for simulation-based "blind insertion" invasive procedural training. During the session, learners experienced and used task-relevant anatomic holoimages for central venous catheter and tube thoracostomy insertion training with enhanced visual cues and haptic feedback. Direct instructor access into the learner's AR/MR headset view of the task trainer was achieved for visual-axis interactive instructional guidance. Investigators implemented a core holoimaging pipeline infrastructure and modular open-access repository to generate and enable access to modular holoimages during exploratory pilot stage applications for invasive procedure training that featured innovative AR/MR techniques on off-the-shelf headset devices.

Peripherally inserted central catheters. Guidewire versus nonguidewire use: a comparative study.

PubMed

Loughran, S C; Edwards, S; McClure, S

1992-01-01

To date, no research articles have been published that explore the practice of using guidewires for placement of peripherally inserted central catheters. The literature contains speculations regarding the pros and cons of guidewire use. However, no studies to date have compared patient outcomes when peripherally inserted central catheter lines are inserted with and without guidewires. To examine the use of guidewires for peripherally inserted central lines, a comparative study was conducted at two acute care facilities, one using guidewires for insertion and one inserting peripherally inserted central catheter lines without guidewires. 109 catheters were studied between January 1, 1990 and January 1, 1991. The primary focus of this study was to examine whether guidewire use places patients at higher risk for catheter-related complications, particularly phlebitis. No significant differences in phlebitis rates between the two study sites were found. Other catheter-related and noncatheter-related complications were similar between the two facilities. The results of this study do not support the belief that guidewire use increases complication rates.

The use of a newspaper insertion to promote DIY testing of vision in India.

PubMed

Murthy, G V; Gupta, S K; Dada, V K; Pant, T D; Savita, C; Sanga, L; Neena, J

2001-08-01

The mass media have the potential to motivate people to participate in self appraisal of their own health status. An innovative communication package was designed to help people to examine vision at home. The impact of publishing the "do it yourself" (DIY) kit in Indian newspapers was evaluated. A pretested bilingual vision testing kit was published in three newspapers. The kit comprised four tumbling Es corresponding to 6/12 line of Snellen's optotypes. Directions on using the kit were enclosed. 3 -7 days after publication of the kit, a telephone survey of newspaper readers was undertaken to evaluate the impact and cost effectiveness. 603 people were contacted over the telephone. 125 (20.73%) subscribed to the newspaper carrying the DIY insertion. 43.2% (54) noticed the insertion of which 88.89% (48) read the enclosed instructions carefully. 58.33% respondents felt sufficiently motivated to contact an ophthalmologist. Graduates had a 3.83 times higher probability of reading the communication insertion compared with others. Differences in relation to other demographic variables were not statistically significant. Newspapers are an excellent medium for communicating self appraisal kits for vision testing. The medium is cost effective and has significant reach in the urban agglomerates of India.

The use of a newspaper insertion to promote DIY testing of vision in India

PubMed Central

Murthy, G; Gupta, S. K.; Dada, V. K.; Pant, T. D.; Savita, C.; Sanga, L.; Neena, J.

2001-01-01

BACKGROUND—The mass media have the potential to motivate people to participate in self appraisal of their own health status. An innovative communication package was designed to help people to examine vision at home. The impact of publishing the "do it yourself" (DIY) kit in Indian newspapers was evaluated.
METHODS—A pretested bilingual vision testing kit was published in three newspapers. The kit comprised four tumbling Es corresponding to 6/12 line of Snellen's optotypes. Directions on using the kit were enclosed. 3 -7 days after publication of the kit, a telephone survey of newspaper readers was undertaken to evaluate the impact and cost effectiveness.
RESULTS—603 people were contacted over the telephone. 125 (20.73%) subscribed to the newspaper carrying the DIY insertion. 43.2% (54) noticed the insertion of which 88.89% (48) read the enclosed instructions carefully. 58.33% respondents felt sufficiently motivated to contact an ophthalmologist. Graduates had a 3.83 times higher probability of reading the communication insertion compared with others. Differences in relation to other demographic variables were not statistically significant.
CONCLUSIONS—Newspapers are an excellent medium for communicating self appraisal kits for vision testing. The medium is cost effective and has significant reach in the urban agglomerates of India.

 PMID:11466254

Inferior vena cava filter insertion through the popliteal vein: enabling the percutaneous endovenous intervention of deep vein thrombosis with a single venous access approach in a single session

PubMed Central

Kim, Hyoung Ook; Kim, Jae Kyu; Park, Jin Gyoon; Yim, Nam Yeol; Kang, Yang Jun; Jung, Hye Doo

2016-01-01

PURPOSE We aimed to evaluate the efficiency of placing an inferior vena cava (IVC) filter through the same popliteal vein access site used for percutaneous endovenous intervention in patients with extensive lower extremity deep vein thrombosis. METHODS This retrospective study included 21 patients who underwent IVC filter insertion through the popliteal vein over a three-year period. Patient medical records were reviewed for the location of the deep vein thrombosis, result of filter removal, and total number of endovascular procedures needed for filter insertion and recanalization of the lower extremity venous system. Follow-up lower extremity computed tomography (CT) venography was also reviewed in each patient to assess the degree of filter tilt in the IVC. RESULTS All patients had extensive lower extremity deep vein thrombosis involving the iliac vein and/or femoral vein. Seventeen patients showed deep vein thrombosis of the calf veins. In all patients, IVC filter insertion and the recanalization procedure were performed during a single procedure through the single popliteal vein access site. In the 17 patients undergoing follow-up CT, the mean tilt angle of the filter was 7.14°±4.48° in the coronal plane and 8.77°±5.49° in the sagittal plane. Filter retrieval was successful in 16 of 17 patients (94.1%) in whom filter retrieval was attempted. CONCLUSION Transpopliteal IVC filter insertion is an efficient technique that results in low rates of significant filter tilt and enables a single session procedure using a single venous access site for filter insertion and percutaneous endovenous intervention. PMID:27559713

Percutaneous biliary covered stent insertion in patients with malignant duodenobiliary obstruction.

PubMed

Lee, Eunsol; Gwon, Dong Il; Ko, Gi-Young; Sung, Kyu-Bo; Yoon, Hyun-Ki; Shin, Ji Hoon; Kim, Jin Hyoung; Ko, Heung Kyu; Song, Ho-Young

2015-02-01

Although the use of polytetrafluoroethylene (PTFE)-covered biliary stents has proven to be feasible for the treatment of benign and malignant biliary disease, less is known regarding the outcomes of percutaneous placement of a covered stent in patients with malignant duodenobiliary obstruction. To investigate the technical and clinical efficacy of the percutaneous placement of a PTFE-covered biliary stent in patients with malignant duodenobiliary obstruction. From April 2007 to September 2012, the medical records of 45 consecutive patients with malignant duodenobiliary obstruction were retrospectively reviewed. All percutaneous biliary stent deployment was performed using PTFE-covered stents, whereas duodenal stent insertion was performed either fluoroscopically or endoscopically using covered or uncovered stents. Biliary stent deployment was technically successful in all patients. None of the stents migrated after deployment. Procedure-related minor complications, including self-limiting hemobilia, occurred in three (7%) patients. Successful internal drainage was achieved in 39 (87%) of the 45 patients. The median survival time after biliary stent placement was 62 days (95% confidence interval, 8-116 days), and the cumulative stent patency rates at 1, 3, 6, and 12 months were 96%, 92%, 75%, and 38%, respectively. The causes of biliary stent dysfunction included stent occlusion caused by a subsequently inserted duodenal stent (n = 7), food impaction (n = 3), and sludge incrustation (n = 1). One patient developed acute cholecystitis 131 days after biliary stent placement and underwent percutaneous transhepatic gallbladder drainage. Percutaneous insertion of a PTFE-covered stent is a safe and effective method for palliative treatment of patients with malignant duodenobiliary obstruction. If possible, subsequent biliary stent insertion is preferable in order to prevent possible biliary stent dysfunction caused by subsequent insertion of a duodenal stent. © The Foundation Acta Radiologica 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

Self-inflicted foreign bodies in lower genitourinary tract in males: Our experience and review of literature

PubMed Central

Mahadevappa, Nagabhushana; Kochhar, Gaurav; Vilvapathy, Karthikeyan Senguttuvan; Dharwadkar, Sachin; Kumar, Sumit

2016-01-01

Objectives: To study retrospectively the frequency, demographic, phenomenological, and psychiatric profile in patients presented with self-insertion of foreign bodies in the lower genitourinary tract in our institute. Materials and Methods: From January 2009 to 2015, the records of patients admitted with self-insertion of foreign bodies into the lower urinary tract were analyzed retrospectively regarding demographic and phenomenological profile, the mode of presentation, diagnosis, management, complications, and possible contributing factors leading to the event. Results: Out of 17,978 inpatients, ten patients (0.055%) presented with foreign body insertion in the lower genitourinary tract in last 6 years. Mean age was 28.1 ± 13.9 (7–50) years. Objects used for insertion were varied from seeds, twigs to the electric wire. The contributing factors were lack of partner, misconception about masturbation, and underlying psychiatric illness. The presenting symptoms were pain and swelling of the penis, difficulty in voiding, and skin ulceration. The diagnosis was possible by simple observation in four patients, X-ray kidney, ureter, and bladder, and sonography of the pelvis in six patients. Five patients had endoscopic retrieval of foreign body, 2 had an open, suprapubic cystotomy, urethrotomy was needed in one patient, and forceps removal in two patients. There were no postoperative complications. Psychiatric profile was evaluated in nine patients. Conclusions: Foreign body insertion to lower urinary tract was rare. A main cause for insertion of foreign bodies was autoerotism, misconceptions regarding masturbation, and underlying psychiatric illness. In addition to suitable method of surgical removal, counseling and psychiatric evaluation are necessary to prevent recurrences or for early detection of psychiatric problems. PMID:27453657

Use of programmable versus nonprogrammable shunts in the management of hydrocephalus secondary to aneurysmal subarachnoid hemorrhage: a retrospective study with cost-benefit analysis.

PubMed

Lee, Lester; King, Nicolas K K; Kumar, Dinesh; Ng, Yew Poh; Rao, Jai; Ng, Huiyu; Lee, Kah Keow; Wang, Ernest; Ng, Ivan

2014-10-01

The choice of programmable or nonprogrammable shunts for the management of hydrocephalus after aneurysmal subarachnoid hemorrhage (SAH) remains undefined. Variable intracranial pressures make optimal management difficult. Programmable shunts have been shown to reduce problems with drainage, but at 3 times the cost of nonprogrammable shunts. All patients who underwent insertion of a ventriculoperitoneal shunt for hydrocephalus after aneurysmal SAH between 2006 and 2012 were included. Patients were divided into those in whom nonprogrammable shunts and those in whom programmable shunts were inserted. The rates of shunt revisions, the reasons for adjustments of shunt settings in patients with programmable devices, and the effectiveness of the adjustments were analyzed. A cost-benefit analysis was also conducted to determine if the overall cost for programmable shunts was more than for nonprogrammable shunts. Ninety-four patients underwent insertion of shunts for hydrocephalus secondary to SAH. In 37 of these patients, nonprogrammable shunts were inserted, whereas in 57 programmable shunts were inserted. Four (7%) of 57 patients with programmable devices underwent shunt revision, whereas 8 (21.6%) of 37 patients with nonprogrammable shunts underwent shunt revision (p = 0.0413), and 4 of these patients had programmable shunts inserted during shunt revision. In 33 of 57 patients with programmable shunts, adjustments were made. The adjustments were for a trial of functional improvement (n = 21), overdrainage (n = 5), underdrainage (n = 6), or overly sunken skull defect (n = 1). Of these 33 patients, 24 showed neurological improvements (p = 0.012). Cost-benefit analysis showed $646.60 savings (US dollars) per patient if programmable shunts were used, because the cost of shunt revision is a lot higher than the cost of the shunt. The rate of shunt revision is lower in patients with programmable devices, and these are therefore more cost-effective. In addition, the shunt adjustments made for patients with programmable devices also resulted in better neurological outcomes.

Humidity data for 9975 shipping packages with cane fiberboard

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

Daugherty, W. L.

The 9975 surveillance program is developing a technical basis to support extending the storage period of 9975 packages in K-Area Complex beyond the currently approved 15 years. A key element of this effort is developing a better understanding of degradation of the fiberboard assembly under storage conditions. This degradation is influenced greatly by the moisture content of the fiberboard, which is not well characterized on an individual package basis. Direct measurements of humidity and fiberboard moisture content have been made on two test packages with cane fiberboard and varying internal heat levels from 0 up to 19W. With an internalmore » heat load, a temperature gradient in the fiberboard assembly leads to varying relative humidity in the air around the fiberboard. However, the absolute humidity tends to remain approximately constant throughout the package. The moisture content of fiberboard varies under the influence of several phenomena. Changes in local fiberboard temperature (from an internal heat load) can cause fiberboard moisture changes through absorption or evaporation. Fiberboard degradation at elevated temperature will produce water as a byproduct. And the moisture level within the package is constantly seeking equilibrium with that of the surrounding room air, which varies on a daily and seasonal basis. One indicator of the moisture condition within a 9975 package might be obtained by measuring the relative humidity in the upper air space, by inserting a humidity probe through a caplug hole. However, the data indicate that for the higher internal heat loads (15 and 19 watts), a large variation in internal moisture conditions produces little or no variation in the air space relative humidity. Therefore, this approach does not appear to be sensitive to fiberboard moisture variations at the higher heat loads which are of most interest to maintaining fiberboard integrity.« less

Risk factors for upper extremity venous thrombosis associated with peripherally inserted central venous catheters.

PubMed

Marnejon, Thomas; Angelo, Debra; Abu Abdou, Ahmed; Gemmel, David

2012-01-01

To identify clinically important risk factors associated with upper extremity venous thrombosis following peripherally inserted central venous catheters (PICC). A retrospective case control study of 400 consecutive patients with and without upper extremity venous thrombosis post-PICC insertion was performed. Patient data included demographics, body mass index (BMI), ethnicity, site of insertion, size and lumen of catheter, internal length, infusate, and co-morbidities, such as diabetes mellitus, congestive heart failure, and renal failure. Additional risk factors analyzed were active cancer, any history of cancer, recent trauma, smoking, a history of prior deep vein thrombosis, and recent surgery, defined as surgery within three months prior to PICC insertion. The prevalence of trauma, renal failure, and infusion with antibiotics and total parenteral nutrition (TPN) was higher among patients exhibiting upper extremity venous thrombosis (UEVT), when compared to controls. Patients developing UEVT were also more likely to have PICC line placement in a basilic vein and less likely to have brachial vein placement (P<.001). Left-sided PICC line sites also posed a greater risk (P=.026). The rate of standard DVT prophylaxis with low molecular weight heparin and unfractionated heparin and the use of warfarin was similar in both groups. Average length of hospital stay was almost double among patients developing UEVT, 19.5 days, when compared to patients undergoing PICC line insertion without thrombosis, 10.8 days (t=6.98, P<.001). In multivariate analysis, trauma, renal failure, left-sided catheters, basilic placement, TPN, and infusion with antibiotics, specifically vancomycin, were significant risk factors for UEVT associated with PICC insertion. Prophylaxis with low molecular weight heparin, unfractionated heparin or use of warfarin did not prevent the development of venous thrombosis in patients with PICCs. Length of hospital stay and cost are markedly increased in patients who develop PICC-associated upper extremity venous thrombosis.

The influence of cholinesterase inhibitor therapy for dementia on risk of cardiac pacemaker insertion: a retrospective, population-based, health administrative databases study in Ontario, Canada.

PubMed

Huang, Allen R; Redpath, Calum J; van Walraven, Carl

2015-04-28

Cholinesterase inhibitors are used to treat the symptoms of dementia and can theoretically cause bradycardia. Previous studies suggest that patients taking these medications have an increased risk of undergoing pacemaker insertion. Since these drugs have a marginal impact on patient outcomes, it might be preferable to change drug treatment rather than implant a pacemaker. This population-based study determined the association of people with dementia exposed to cholinesterase inhibitor medication and pacemaker insertion. We used data from the Ontario health administrative databases from January 1, 1993 to June 30, 2012. We included all community-dwelling seniors who had a code for dementia and were exposed to cholinesterase inhibitors (donezepil, galantamine, and rivastigmine) and/or drugs used to treat co-morbidities of hypertension, diabetes, depression and hypothyroidism. We controlled for exposure to anti-arrhythmic drugs. Observation started at first exposure to any medication and continued until the earliest of pacemaker insertion, death, or end of study. 2,353,909 people were included with 96,000 (4.1%) undergoing pacemaker insertion during the observation period. Case-control analysis showed that pacemaker patients were less likely to be coded with dementia (unadjusted OR 0.42 [95%CI 0.41-0.42]) or exposed to cholinesterase inhibitors (unadjusted OR 0.39 [95%CI 0.37-0.41]). That Cohort analysis showed patients with dementia taking cholinesterase inhibitors had a decreased risk of pacemaker insertion (unadj-HR 0.58 [0.55-0.61]). Adjustment for patient age, sex, and other medications did not notably change results, as did restricting the analysis to incident users. Patients taking cholinesterase inhibitors rarely undergo, and have a significantly reduced risk of, cardiac pacemaker insertion.

Removable self-expanding metal stents insertion for the treatment of perforations and postoperative leaks of the esophagus.

PubMed

Nasa, Mukesh; Sharma, Zubin Dev; Choudhary, Narendra S; Puri, Rajesh; Sud, Randhir

2016-03-01

Esophageal rupture, spontaneous or iatrogenic, is associated with significant morbidity and mortality. The current study aims at highlighting the various clinical scenarios, where esophageal fully covered self-expanding removable metal stents (FCSEMS) can be used in esophageal rupture. In patients who underwent insertion of FCSEMS between January 2013 and June 2014, all data regarding demographics, indications, insertion, removal, and outcomes were studied retrospectively. Seven patients underwent the placement of esophageal covered SEMS. Two patients had Boerhaave syndrome, two had leak following the repair of aortic aneurysm, one had extensive esophageal injury following transesophageal echocardiography, one had carcinoma esophagus with tracheaesophageal fistula, and one had dehiscence of esophagogastric anastomosis. Stent insertion was successful in all the patients; one had stent migration which was managed endoscopically. Two patients died due to underlying illness; the rest had successful removal of stents after 8-10 weeks and good outcomes. Esophageal FCSEMS placement is safe and effective modality in management of patients with esophageal rupture.

APPARATUS AND TECHNIC FOR THE ADMINISTRATION OF INTRACAVITARY RADIOACTIVE ISOTOPES

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

Michaud, N.J.; Liegner, L.M.

1961-08-01

The method of administration of radioactive isotopes in the treatment of pleural effusions and ascites associated with cancer will vary according to the therapeutic technic. A procedure with a suitable apparatus that utilizes an economical and sterile disposable package is described. The radioactive isotope, whether colloidal chromic phosphate (P/sup 32/) or colloidal gold (Au/sup 198/), can be obtained in th e exact amount prescribed. The entire apparatus is assembled within a few minutes under sterile conditions. Before the hypodermic needles are inserted into the radioactive isotope vial, the air is removed from the tubing by the flow of saline inmore » each segment. Each section is then clamped. The shielded radioactive isotope is then placed on a table or stand and the rubber seal of the vial is swabbed with alcohol or iodine. The inflow needle is inserted just through the rubber stopper and the outflow needle is inserted to the bottom of the vial. This procedure is carried out without removing the vial from the lead container. (auth)« less

Strategies to improve electrode positioning and safety in cochlear implants.

PubMed

Rebscher, S J; Heilmann, M; Bruszewski, W; Talbot, N H; Snyder, R L; Merzenich, M M

1999-03-01

An injection-molded internal supporting rib has been produced to control the flexibility of silicone rubber encapsulated electrodes designed to electrically stimulate the auditory nerve in human subjects with severe to profound hearing loss. The rib molding dies, and molds for silicone rubber encapsulation of the electrode, were designed and machined using AutoCad and MasterCam software packages in a PC environment. After molding, the prototype plastic ribs were iteratively modified based on observations of the performance of the rib/silicone composite insert in a clear plastic model of the human scala tympani cavity. The rib-based electrodes were reliably inserted farther into these models, required less insertion force and were positioned closer to the target auditory neural elements than currently available cochlear implant electrodes. With further design improvements the injection-molded rib may also function to accurately support metal stimulating contacts and wire leads during assembly to significantly increase the manufacturing efficiency of these devices. This method to reliably control the mechanical properties of miniature implantable devices with multiple electrical leads may be valuable in other areas of biomedical device design.

Preparation and screening of an arrayed human genomic library generated with the P1 cloning system.

PubMed Central

Shepherd, N S; Pfrogner, B D; Coulby, J N; Ackerman, S L; Vaidyanathan, G; Sauer, R H; Balkenhol, T C; Sternberg, N

1994-01-01

We describe here the construction and initial characterization of a 3-fold coverage genomic library of the human haploid genome that was prepared using the bacteriophage P1 cloning system. The cloned DNA inserts were produced by size fractionation of a Sau3AI partial digest of high molecular weight genomic DNA isolated from primary cells of human foreskin fibroblasts. The inserts were cloned into the pAd10sacBII vector and packaged in vitro into P1 phage. These were used to generate recombinant bacterial clones, each of which was picked robotically from an agar plate into a well of a 96-well microtiter dish, grown overnight, and stored at -70 degrees C. The resulting library, designated DMPC-HFF#1 series A, consists of approximately 130,000-140,000 recombinant clones that were stored in 1500 microtiter dishes. To screen the library, clones were combined in a pooling strategy and specific loci were identified by PCR analysis. On average, the library contains two or three different clones for each locus screened. To date we have identified a total of 17 clones containing the hypoxanthine-guanine phosphoribosyltransferase, human serum albumin-human alpha-fetoprotein, p53, cyclooxygenase I, human apurinic endonuclease, beta-polymerase, and DNA ligase I genes. The cloned inserts average 80 kb in size and range from 70 to 95 kb, with one 49-kb insert and one 62-kb insert. Images PMID:8146166

Comparison between gastrostomy feeding and self-expandable metal stent insertion for patients with esophageal cancer and dysphagia.

PubMed

Min, Yang Won; Jang, Eun Young; Jung, Ji Hey; Lee, Hyuk; Min, Byung-Hoon; Lee, Jun Haeng; Rhee, Poong-Lyul; Kim, Jae J

2017-01-01

Self-expandable metal stent (SEMS) insertion and percutaneous gastrostomy (PG) feeding are commonly used for patients with esophageal cancer and dysphagia. This study aimed to compare outcomes between SEMS insertion and PG feeding for them. We retrospectively analyzed 308 patients with esophageal cancer who underwent fully covered SEMS insertion (stent group) or PG (gastrostomy group) for dysphagia due to tumor. Patients with other causes of dysphagia, such as radiation-induced or postoperative stricture, were excluded from the study. Clinical outcomes were compared between the two groups, including overall survival and need for additional intervention and postprocedural nutritional status. At baseline, the stent group (n = 169) had more stage IV patients, less cervical cancers, and received radiotherapy and esophagectomy less often than the gastrostomy group (n = 64). The Kaplan-Meier curves showed higher overall survival in the gastrostomy group than in the stent group. Multivariate analysis revealed that PG was associated with better survival compared with SEMS insertion (hazard ratio 0.541, 95% confidence interval 0.346-0.848, p = 0.007). In addition, the gastrostomy group needed additional intervention less often (3.1% vs. 21.9%, p < 0.001) and experienced less decrease in serum albumin levels (-0.15 ± 0.56 g/dL vs. -0.39 ± 0.58 g/dL, p = 0.011) than the stent group after procedure. Our data suggested that, compared with SEMS insertion, PG is associated with better overall survival in patients with esophageal cancer and dysphagia. Stabilized nutritional status by PG may play a role in improving patient survival.

Complications of silicone stent insertion in patients with expiratory central airway collapse.

PubMed

Murgu, Septimiu D; Colt, Henri G

2007-12-01

Silicone stent insertion is an alternative treatment for expiratory central airway collapse. This study evaluates the complications (mucus plugging, migration, and granulation tissue) associated with stenting in patients who failed medical therapy and were not surgical candidates. Chart review from 15 consecutive patients treated by silicone stent insertion was done over a 2-year period. Outcomes included (1) changes in functional class, extent and severity of airway collapse (graded from 1 to 4 by using a multidimensional system), procedure- and stent-related complications at 48 hours after stent insertion; (2) frequency of stent-related complications; and (3) frequency of emergent flexible and rigid bronchoscopy (scheduled or emergent) over the follow-up period. Mean functional class and severity and extent of airway collapse significantly improved within 48 hours after treatment (p < 0.05). There were no perioperative deaths. Stent-related complications within 48 hours after stent insertion occurred in 3 patients (1 granulation, 1 migration, and 1 mucus plugging). The mean duration of follow-up for the 12 patients who underwent clinical and bronchoscopic follow-up was 188 days. Twenty-six stent-related complications (12 mucus plugs, 8 migrations, and 6 granulation tissues) were seen in 10 of the 12 patients. Five emergent flexible bronchoscopies and 14 rigid bronchoscopies (6 of which were emergent) were performed during the follow-up period. Silicone stent insertion improves functional status immediately after intervention in patients with expiratory central airway collapse, but is associated with a high rate of stent-related complications and need for repeat bronchoscopic interventions.

21 CFR 876.5830 - Hemodialyzer with disposable insert (Kiil type).

Code of Federal Regulations, 2010 CFR

2010-04-01

... Hemodialyzer with disposable insert (Kiil type). (a) Identification. A hemodialyzer with disposable inserts (Kiil type) is a device that is used as a part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that includes disposable inserts consisting of layers...

The accuracy and the safety of individualized 3D printing screws insertion templates for cervical screw insertion.

PubMed

Deng, Ting; Jiang, Minghui; Lei, Qing; Cai, Lihong; Chen, Li

2016-12-01

Clinical trial for cervical screw insertion by using individualized 3-dimensional (3D) printing screw insertion templates device. The objective of this study is to evaluate the safety and accuracy of the individualized 3D printing screw insertion template in the cervical spine. Ten patients who underwent posterior cervical fusion surgery with cervical pedicle screws, laminar screws or lateral mass screws between December 2014 and December 2015 were involved in this study. The patients were examined by CT scan before operation. The individualized 3D printing templates were made with photosensitive resin by a 3D printing system to ensure the screw shafts entered the vertebral body without breaking the pedicle or lamina cortex. The templates were sterilized by a plasma sterilizer and used during the operation. The accuracy and the safety of the templates were evaluated by CT scans at the screw insertion levels after operation. The accuracy of this patient-specific template technique was demonstrated. Only one screw axis greatly deviated from the planned track and breached the cortex of the pedicle because the template was split by rough handling and then we inserted the screws under the fluoroscopy. The remaining screws were inserted in the track as preoperative design and the screw axis deviated by less than 2 mm. Vascular or neurologic complications or injuries did not happen. And no infection, broken nails, fracture of bone structure, or screw pullout occurred. This study verified the safety and the accuracy of the individualized 3D printing screw insertion templates in the cervical spine as a kind of intraoperative screw navigation. This individualized 3D printing screw insertion template was user-friendly, moderate cost, and enabled a radiation-free cervical screw insertion.

Vaginal contraceptive film gains wider acceptance.

PubMed

1992-09-01

In US health departments and family planning clinics, women are beginning to accept vaginal contraceptive film more widely. Further, direct sales of this method, which is also distributed over the counter, has increased. In fact, in 1991, vaginal contraceptive film was the top selling contraceptive in pharmacies. This 2.5 sq. inch water-soluble film is impregnated with nonoxynol-9. The woman uses her finger to insert the folded square as close as possible to the cervix 5-60 minutes before intercourse. If the time between acts of intercourse is greater than 1 hour, she must insert another square. After it dissolves, it is a firm gel removed by vaginal and cervical fluids. The company realizes that its relatively high cost (about $3.59 for 3 films) prevents some family planning providers from offering the film. It has tried to cut costs by not using extra packaging material and by manufacturing it in the US instead of ain England. A manager of the family planning clinic at R.E. Thomason County Hospital in El Paso, Texas, notes that user compliance is higher with the vaginal contraceptive film than foam. In fact, patients at the Planned Parenthood League of Middlesex County, New Jersey, favor the film because it is less messy than foam. Teenagers in El Paso prefer the film because of the privacy issue and gives them more control to protect themselves from pregnancy. A worker at the New Jersey clinic recommends the film as a backup method for women beginning to use oral contraceptives. She also suggests to patients requesting condoms to also use the film. The company makes the same recommendation. Yet, family planning workers note that some women cannot convince partners to use the condom. 90% of patients at the El Paso clinic are Hispanic, and they tend to not accept condom use. Some providers suggest using 2 applications of the film to defend against sexually transmitted diseases, but there is no evidence that double application actually does so.

An educational package that supports laycarers to safely manage breakthrough subcutaneous injections for home-based palliative care patients: development and evaluation of a service quality improvement.

PubMed

Healy, Sue; Israel, Fiona; Charles, Margaret A; Reymond, Liz

2013-06-01

Palliative care services strive to support people to live and die well in their chosen environment, with optimal symptom control and a pattern of care supportive of laycarers. The likelihood of patients remaining at home often depends upon laycarers, who may be required to manage subcutaneous medications. This study reports the development, trial and evaluation of a package that teaches laycarers to manage subcutaneous medications used for symptom control in home-based patients. The package was developed by palliative care stakeholders and comprises an educational session, delivered by nurses, and a range of demonstrative, audiovisual and written resources. The package was trialled across 24 sites and was evaluated by 76 laycarers (pre- and post-use) and 53 nurses (at study completion). Outcomes of primary interest were perceived global usefulness of the package and rated relevance of components. Laycarers and nurses rated the usefulness and relevance of the package highly - all means were above 5 on a 7-point scale. Also, laycarers were invited to comment on the package, and three focus groups for 26 nurses explored post hoc issues following package implementation. In terms of the palliative patient's illness trajectory, consensus was that the time for package introduction depended upon each particular clinical situation and laycarer. Nursing opinion was divided concerning whether it is safe and appropriate for laycarers to manage subcutaneous injections. Nevertheless, this study demonstrates that the package supports laycarers to manage subcutaneous medications. This has important implications for families, services and health-care systems.

Evaluation of lorcaserin for the treatment of obesity.

PubMed

Berlie, Helen D; Hurren, Kathryn M

2013-08-01

Obesity is an epidemic associated with significant morbidity. Lorcaserin , a novel serotonin 2C receptor antagonist, was recently approved as an adjunct to lifestyle modification for long-term weight loss and maintenance. Clinical studies in patients without diabetes demonstrated 5.8% mean weight loss from baseline with lorcaserin compared to 2.5% with placebo and over twice as many patients achieved ≥ 5% weight loss. Patients with diabetes achieved mean weight loss of 4.5% with lorcaserin compared to 1.5% with placebo as well as modest improvements in glycemic outcomes. The authors review the pharmacology and clinical efficacy as well as the safety and tolerability of lorcaserin. This was achieved through a PubMed search (1960 - present) on lorcaserin to generate the key literature in the area. The lorcaserin package insert and Food and Drug Administration briefing documents were also used to identify relevant information. To assess long-term clinical efficacy and safety, the authors used studies with a minimum duration of one year. Lorcaserin induces moderate but significant weight loss compared to placebo as an adjunct to lifestyle modification. Although head-to-head comparison trials are not available, lorcaserin is likely less effective but better tolerated than its recently approved competitor, phentermine/topiramate. Cardiovascular outcome data will be invaluable in determining lorcaserin's eventual utilization and place in therapy.

Drug packaging in 2015: risky industry choices and lax regulation.

PubMed

2016-06-01

Prescrire examined the packaging quality of 240 drugs in 2015. No new advances were identified, but drug packaging continues to expose patients to a variety of dangers. Some past advances persist: for example, INNs are often more legible, and recent patient leaflets tend to be clearer and more informative. But these measures are not applied to all drugs, and are rarely applied retroactively to older drugs. The overall picture in 2015 is that many drugs are difficult to identify, risky or downright dangerous to prepare, or supplied with patient leaflets that fail to correctly inform patients about their medication. And measures to prevent drug poisoning in children need to be completely rethought. It is high time for regulators and policy makers to take the issue of drug packaging seriously, so blatant are the signs of their failure to do so: the increasing use of bulk bottles for new drugs; failure to implement guidelines on safe drug packaging (unit-dose presentations, appropriate dosing devices, etc.); and expanding umbrella brands which, given the dangers they pose to patients, should be banned instead. All things considered, healthcare professionals and patients must remain vigilant and report any dangers they identify. A major European initiative on drug packaging is becoming increasingly necessary.

Disposable laryngeal mask airway (Soft Seal) for endotracheal intubation: FOB guidance technique and blind technique.

PubMed

Boonmak, S; Boonmak, P; Bunsaengjaroen, P; Srichaipanha, S

2006-05-01

To evaluate disposable LMA for endotracheal intubation using the FOB guidance and blind techniques. The authors included ASA class I-II patients between 15 and 60 years of age, with mouth opening more than 3 cm, scheduled for elective surgery. The authors excluded patients with any history of gastro-esophageal reflux, full stomach or a body weight < 30 kg. All of the patients received standard general anesthesia. After inducing anesthesia, a disposable LMA No. 3 or No. 4 (Soft Seal, Smiths Medical, Portex Inc, USA) was inserted while the patient was in the sniff position. The authors recorded the insertion time, the ease of insertion, the anatomic placement and position. The authors then inserted a flexible endotracheal tube (No. 6.5 for LMA No. 4 and No. 6 for LMA No. 3) and recorded the success rate and the ease of insertion. After three failures, the authors used FOB guidance. Sixty patients were enrolled (32 males). The mean +/- SD age and BMI was 43.2 +/- 13.4 years and 22.6 +/- 3.9, respectively. Most of the patients had a Mallampati of grade I. The mean +/- SD insertion time was 24.6 +/- 16.1 sec. After the FOB evaluation, only 27 patients had an anatomic placement in full view of the glottis. Eighteen patients had vocal cords in the middle part of the opening. The success rate of blind endotracheal intubation was 5 percent (95%CI 1.0-13.9) (3/60); while the success rate with FOB guidance was 85 percent (95%CI 73.4-92.9). A disposable laryngeal mask airway (Soft Seal) for blind endotracheal intubation had a low success rate, but it could be used more successfully with FOB guidance.

Ultrasound-guided central venous catheterization in cancer patients improves the success rate of cannulation and reduces mechanical complications: A prospective observational study of 1,978 consecutive catheterizations

PubMed Central

2010-01-01

Background A central venous catheter (CVC) currently represents the most frequently adopted intravenous line for patients undergoing infusional chemotherapy and/or high-dose chemotherapy with hematopoietic stem-cell transplantation and parenteral nutrition. CVC insertion represents a risk for pneumothorax, nerve or arterial punctures. The aim of this prospective observational study was to explore the safety and efficacy of CVC insertion under ultrasound (US) guidance and to confirm its utility in clinical practice in cancer patients. Methods Consecutive adult patients attending the oncology-hematology department were eligible if they had solid or hematologic malignancies and required CVC insertion. Four types of possible complication were defined a priore: mechanical, thrombotic, infection and malfunctioning. The patient was placed in Trendelenburg's position, a 7.5 MHZ puncturing US probe was placed in the supraclavicular site and a 16-gauge needle was advanced under real-time US guidance into the last portion of internal jugular vein. The Seldinger technique was used to place the catheter, which was advanced into the superior vena cava until insertion into right atrium. Within two hours after each procedure, an upright chest X-ray and ultrasound scanning were carried out to confirm the CVC position and to rule out a pneumotorax. CVC-related infections, symptomatic vein thrombosis and malfunctioning were recorded. Results From December 2000 to January 2009, 1,978 CVC insertional procedures were applied to 1,660 consecutive patients. The procedure was performed 580 times in patients with hematologic malignancies and 1,398 times those with solid tumors. A single-needle puncture of the vein was performed on 1,948 of 1,978 procedures (98.48%); only eighteen attempts among 1,978 failed (0.9%). No pneumotorax, no major bleeding, and no nerve puncture were reported; four cases (0.2%) showed self-limiting hematomas. The mean lifespan of CVC was 189.7 +/- 18.6 days (range 7-701). Symptomatic deep-vein thrombosis of the upper limbs developed in 48 patients (2.42%). Catheter-related infections occurred in 197 (9.96%) of the catheters inserted. They were successfully treated with antibiotics and only in 48 (2.9%) patients definitive CVC removal was required for infection and/or thrombosis or malfunctioning. Conclusions This study represents the largest published series of consecutive patients with cancer undergoing CVC insertion under US guidance; this procedure allowed the completion of the therapeutic program for 1,930/1,978 (97.6%) of the catheters inserted. The absence of pneumotorax and other major complications indicates that US guidance should be mandatory for CVC insertion in patients with cancer. PMID:20958986

Safe and accurate midcervical pedicle screw insertion procedure with the patient-specific screw guide template system.

PubMed

Kaneyama, Shuichi; Sugawara, Taku; Sumi, Masatoshi

2015-03-15

Clinical trial for midcervical pedicle screw insertion using a novel patient-specific intraoperative screw guiding device. To evaluate the availability of the "Screw Guide Template" (SGT) system for insertion of midcervical pedicle screws. Despite many efforts for accurate midcervical pedicle screw insertion, there still remain unacceptable rate of screw malpositioning that might cause neurovascular injuries. We developed patient-specific SGT system for safe and accurate intraoperative screw navigation tool and have reported its availability for the screw insertion to C2 vertebra and thoracic spine. Preoperatively, the bone image on computed tomography was analyzed and the trajectories of the screws were designed in 3-dimensional format. Three types of templates were created for each lamina: location template, drill guide template, and screw guide template. During the operations, after engaging the templates directly with the laminae, drilling, tapping, and screwing were performed with each template. We placed 80 midcervical pedicle screws for 20 patients. The accuracy and safety of the screw insertion by SGT system were evaluated using postoperative computed tomographic scan by calculation of screw deviation from the preplanned trajectory and evaluation of screw breach of pedicle wall. All templates fitted the laminae and screw navigation procedures proceeded uneventfully. All screws were inserted accurately with the mean screw deviation from planned trajectory of 0.29 ± 0.31 mm and no neurovascular complication was experienced. We demonstrated that our SGT system could support the precise screw insertion in midcervical pedicle. SGT prescribes the safe screw trajectory in a 3-dimensional manner and the templates fit and lock directly to the target laminae, which prevents screwing error along with the change of spinal alignment during the surgery. These advantages of the SGT system guarantee the high accuracy in screw insertion, which allowed surgeons to insert cervical pedicle screws safely. 3.

Afatinib and Cetuximab in Four Patients With EGFR Exon 20 Insertion-Positive Advanced NSCLC.

PubMed

van Veggel, Bianca; de Langen, Adrianus J; Hashemi, Sayed M S; Monkhorst, Kim; Heideman, Daniëlle A M; Thunnissen, Erik; Smit, Egbert F

2018-04-24

EGFR exon 20 insertions comprise 4% to 9% of EGFR mutated NSCLC. Despite being an oncogenic driver, they are associated with primary resistance to EGFR tyrosine kinase inhibitors (TKIs). We hypothesized that dual EGFR blockade with afatinib, an irreversible EGFR TKI, and cetuximab, a monoclonal antibody against EGFR, could induce tumor responses. Four patients with EGFR exon 20 insertion-positive NSCLC were treated with afatinib 40 mg once daily and cetuximab 250 mg/m 2 to 500 mg/m 2 every 2 weeks. All patients had stage IV adenocarcinoma of the lung harboring an EGFR exon 20 insertion mutation. Previous lines of treatment consisted of platinum doublet chemotherapy (n = 4) and EGFR TKI (n = 2). Three of four patients showed a partial response according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Median progression-free survival was 5.4 months (95% confidence interval: 0.0 - 14.2 months; range 2.7 months - 17.6 months). Toxicity was manageable with appropriate skin management and dose reduction being required in two patients. Dual EGFR blockade with afatinib and cetuximab may induce tumor responses in patients with EGFR exon 20 insertion-positive NSCLC. Copyright © 2018 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.

Detection of drugs in the urine of body-packers.

PubMed

Gherardi, R K; Baud, F J; Leporc, P; Marc, B; Dupeyron, J P; Diamant-Berger, O

1988-05-14

The presence of opiates and benzoylecgonine, the major metabolite of cocaine, in the urine was detected by means of enzyme immunoassay in a series of 120 smugglers who had either ingested or inserted into their rectum cocaine or heroin packaged for transportation. There was a striking relation between the presence of drugs in the urine and swallowing of drug-filled bundles (cocaine 49 of 50 cases, heroin 9 of 10). The proportion of positive results was also high in cases of rectal insertion (cocaine 2 of 2, heroin 35 of 58). In 30 cases of cocaine-packet ingestion, serial measurements showed that the accuracy of the test progressively decreased with respect to the detection of residual packets in the body. Drug detection in the urine of suspected body-packers seems to be a useful test, positive results justifying subsequent radiological investigations.

Success of Urgent-Start Peritoneal Dialysis in a Large Canadian Renal Program

PubMed Central

Alkatheeri, Ali M.A.; Blake, Peter G.; Gray, Daryl; Jain, Arsh K.

2016-01-01

♦ Background: Many patients start renal replacement therapy urgently on in-center hemodialysis via a central venous catheter, which is considered suboptimal. An alternative approach to manage these patients is to start them on peritoneal dialysis (PD). In this report, we describe the first reported Canadian experience with an urgent-start PD program. Additionally we reviewed the literature in this area. ♦ Methods: In this prospective observational study, we report on our experience in a single academic center. This program started in July 2010. We included patients who initiated PD urgently, that is within 2 weeks of catheter insertion. We followed all incident PD patients until October 2013 for mechanical and infectious complications. Peritoneal dialysis catheters were inserted either percutaneously or laparoscopically and dialysis was initiated in either an inpatient or outpatient setting. ♦ Results: Thirty patients were started on urgent PD during our study period. Follow-up ranged from 28 to 1,050 days. Twenty insertions (66.7 %) were done percutaneously and 10 (33.3%) were laparoscopic. Dialysis was initiated within 2 weeks (range: 0 – 13 days, median = 6 days). Twenty-four patients (80%) started PD in an outpatient setting and 6 patients (20%) required immediate inpatient PD start. Three patients (10%) developed a minor peri-catheter leak during the first week of training that was managed conservatively. There were no episodes of peritonitis or exit-site/tunnel infection during the first 4 weeks post-insertion. Four patients (13.3 %) from the percutaneous insertion group and 2 patients (6.7%) from laparoscopic insertions developed catheter dysfunction due to migration, which was managed by repositioning, without need for catheter replacement or modality switch. ♦ Conclusions: Our results are consistent with other studies in this area and demonstrate that urgent-start PD is an acceptable and safe alternative to hemodialysis in patients who need to start dialysis urgently without established dialysis access. PMID:26374834

Success of Urgent-Start Peritoneal Dialysis in a Large Canadian Renal Program.

PubMed

Alkatheeri, Ali M A; Blake, Peter G; Gray, Daryl; Jain, Arsh K

2016-01-01

♦ Many patients start renal replacement therapy urgently on in-center hemodialysis via a central venous catheter, which is considered suboptimal. An alternative approach to manage these patients is to start them on peritoneal dialysis (PD). In this report, we describe the first reported Canadian experience with an urgent-start PD program. Additionally we reviewed the literature in this area. ♦ In this prospective observational study, we report on our experience in a single academic center. This program started in July 2010. We included patients who initiated PD urgently, that is within 2 weeks of catheter insertion. We followed all incident PD patients until October 2013 for mechanical and infectious complications. Peritoneal dialysis catheters were inserted either percutaneously or laparoscopically and dialysis was initiated in either an inpatient or outpatient setting. ♦ Thirty patients were started on urgent PD during our study period. Follow-up ranged from 28 to 1,050 days. Twenty insertions (66.7%) were done percutaneously and 10 (33.3%) were laparoscopic. Dialysis was initiated within 2 weeks (range: 0-13 days, median = 6 days). Twenty-four patients (80%) started PD in an outpatient setting and 6 patients (20%) required immediate inpatient PD start. Three patients (10%) developed a minor peri-catheter leak during the first week of training that was managed conservatively. There were no episodes of peritonitis or exit-site/tunnel infection during the first 4 weeks post-insertion. Four patients (13.3%) from the percutaneous insertion group and 2 patients (6.7%) from laparoscopic insertions developed catheter dysfunction due to migration, which was managed by repositioning, without need for catheter replacement or modality switch. ♦ Our results are consistent with other studies in this area and demonstrate that urgent-start PD is an acceptable and safe alternative to hemodialysis in patients who need to start dialysis urgently without established dialysis access. Copyright © 2016 International Society for Peritoneal Dialysis.

Outcomes of single- vs double-cuff artificial urinary sphincter insertion in low- and high-risk profile male patients with severe stress urinary incontinence.

PubMed

Ahyai, Sascha A; Ludwig, Tim A; Dahlem, Roland; Soave, Armin; Rosenbaum, Clemens; Chun, Felix K-H; Fisch, Margit; Schmid, Marianne; Kluth, Luis A

2016-10-01

To evaluate continence and complication rates of bulbar single-cuff (SC) and distal bulbar double-cuff (DC) insertion in male patients with severe stress urinary incontinence (SUI) according to whether the men were considered low or high risk for unfavourable artificial urinary sphincter (AUS) outcomes. In all, 180 male patients who underwent AUS implantation between 2009 and 2013 were followed according to institutional standards. Patients with previous pelvic radiation therapy, open bulbar urethral or UI surgery ('high risk') underwent distal bulbar DC (123 patients) insertion, all others ('low risk') had proximal bulbar SC (57) insertion. Primary and secondary endpoints consisted of continence and complication rates. Kaplan-Meier analysis determined explantation-free survival, and Cox regression models assessed risk factors for persistent UI and explantation. The median follow-up was 24 months. Whereas there was no significant difference in pad usage/objective continence after SC vs DC insertion, superior rates of subjective/social continence and less persistent UI were reported by the patients with DC devices (all P ≤ 0.02). Overall, device explantation (erosion, infection or mechanical failure) occurred in 12.8% of patients. While early (<6 weeks) complication rates compared with SC patients were similar (P > 0.05), DC patients had a 5.7-fold higher risk of device explantation during late follow-up (P = 0.02) and significantly shorter explantation-free survival (log-rank, P = 0.003). Distal bulbar DC insertion in patients with a 'high-risk' profile (previous pelvic radiation, urethral surgery) leads to similar objective continence, but higher explantation rates when compared with patients considered 'low risk' with proximal bulbar SCs. Randomised controlled trials comparing both devices will be needed to determine whether the higher explanations rates are attributable to the DC device or to underlying risk factors. © 2016 The Authors BJU International © 2016 BJU International Published by John Wiley & Sons Ltd.

Bacteriology of urinary tract infection associated with indwelling J ureteral stents.

PubMed

Kehinde, Elijah O; Rotimi, Vincent O; Al-Hunayan, Adel; Abdul-Halim, Hamdy; Boland, Fareeda; Al-Awadi, Khaleel A

2004-11-01

To investigate the microorganisms responsible for urinary tract infection (UTI) and stent colonization in patients with indwelling J ureteral stents and to compare the antimicrobial susceptibility pattern of the isolates from urine and J stents in order to establish the etiologic agents of bacteriuria and colonized stents in such patients and provide baseline data on an antibiotic policy for the urology unit. Midstream urine from 250 patients requiring J stent insertion was investigated microbiologically prior to stent insertion and on the day of stent removal. After stent removal, 3 to 5 cm of the tip located in the bladder was also sent for culture. Patients' bio-data and underlying diseases were documented. Those with no known systemic diseases ("normal patients") were also studied as controls. Of the 250 patients studied, 152 (61%) were normal, while 27 (11%), 53 (21%), and 18 (7%) had diabetes mellitus (DM), chronic renal failure (CRF), and diabetic nephropathy (DN), respectively. The mean duration of stent retention was 27 days. All microbial isolates were tested for their susceptibility to a panel of 10 antibiotics. Twelve patients (5%) before stent insertion and 42 patients (17%; P < 0.001) on the day of stent removal had positive urine cultures. One hundred four stents (42%) were culture positive. Of the 104 patients with positive stent cultures, in 62 patients (60%), urine culture was sterile. The commonest isolates were Escherichia coli, Enterococcus spp., Staphylococcus spp., Pseudomonas, and Candida spp. On the day of stent removal, urine culture was positive in 28% of the normal patients compared with 57% (P = 0.11), 78% (P < 0.001), and 62% (P < 0.001) of patients with CRF, DM, and DN, respectively. Stent isolates were more resistant to antibiotics than the organism isolated before stent insertion. An indwelling J ureteral stent carries a significant risk of bacteriuria and stent colonization. The sensitivity of urine culture to stent colonization is low, and therefore, a negative culture does not rule out a colonized stent. Bacteria cultured from urine after stent insertion and from the stents are more resistant to antibiotics than are those cultured from urine before stent insertion. Norfloxacin or ciprofloxacin is recommended as prophylaxis prior to stent insertion, and an aminoglycoside can be added to treat symptomatic patients with severe infections.

Modified perianal/pericapsular anesthesia for transrectal biopsy of prostate in patients with anal rectal problems.

PubMed

Kravchick, Sergey; Yoffe, Boris; Cytron, Shmuel

2007-01-01

To modify our technique of perianal anesthesia and use it in patients with painful conditions of the rectum and/or anus. A total of 31 consecutive patients with anal-rectal problems underwent prostate needle biopsy. Of these, 17 were referred to our hospital after vain attempts to insert a transrectal ultrasound probe. Patients received a perianal-pericapsular injection of 1% lidocaine. Pain perception was separately assessed for probe insertion and biopsies using a visual pain analog score. Only in 1 patient were we unable to insert the transrectal ultrasound probe. The mean patient age was 65.28 +/- 5.35 years. We performed a mean of 12.25 biopsies per case. At probe insertion, the mean pain score was 2.2 +/- 0.83. During the biopsy punctures, the mean pain level was 2.53 +/- 1.054. We did not find any increase in the complication rate related to the anesthesia method. Modified perianal anesthesia can be used for transrectal ultrasound-guided biopsy of the prostate in patients with anal-rectal problems, because it provides significant pain relief.

Construction and production of oncotropic vectors, derived from MVM(p), that share reduced sequence homology with helper plasmids.

PubMed

Clément, Nathalie; Velu, Thierry; Brandenburger, Annick

2002-09-01

The production of currently available vectors derived from autonomous parvoviruses requires the expression of capsid proteins in trans, from helper sequences. Cotransfection of a helper plasmid always generates significant amounts of replication-competent virus (RCV) that can be reduced by the integration of helper sequences into a packaging cell line. Although stocks of minute virus of mice (MVM)-based vectors with no detectable RCV could be produced by transfection into packaging cells; the latter appear after one or two rounds of replication, precluding further amplification of the vector stock. Indeed, once RCVs become detectable, they are efficiently amplified and rapidly take over the culture. Theoretically RCV-free vector stocks could be produced if all homology between vector and helper DNA is eliminated, thus preventing homologous recombination. We constructed new vectors based on the structure of spontaneously occurring defective particles of MVM. Based on published observations related to the size of vectors and the sequence of the viral origin of replication, these vectors were modified by the insertion of foreign DNA sequences downstream of the transgene and by the introduction of a consensus NS-1 nick site near the origin of replication to optimize their production. In one of the vectors the inserted fragment of mouse genomic DNA had a synergistic effect with the modified origin of replication in increasing vector production.

Evaluation of package inserts of Ayurveda drug formulations from Mumbai city.

PubMed

Shirolkar, Sudatta; Tripathi, Raakhi K; Potey, Anirudha V

2015-01-01

Package insert (PI) is a vital document accompanying a prescribed medication to provide information to the prescriber and end-user at a glance. Studies regarding PIs of Ayurvedic medicines in accordance with standard guidelines are lacking. Present study was undertaken to evaluate PI of Ayurveda drugs. PIs of Ayurveda drugs were obtained from five randomly selected Ayurveda medical shops located in three main zones of Mumbai. From each medical shop, a range of 15-20 PI was planned to be collected for different formulations. It was decided to collect a minimum fifty PIs/group for equitable distribution of various formulations in period of January-June2013. Checklist was prepared, and content validity was achieved. Final validated checklist contained a total of 13 items, and the presence or absence of information pertaining to these items on the PI was evaluated. Any other additional information present on PI was also noted. Each item was analyzed and expressed as percentages. The information on 258 PIs included: Name of ingredients (67%), quantity of ingredients (47.27%), route of administration (86.8%), dosage form (86.8%), indications (18%), dose (18%), contraindications (18%), side effects (9%), shelf life (5.81%), storage conditions (11%), and manufacturers name with contact details (34%). PIs accompanying Ayurveda medicinal products in India are deficient in information required to be furnished by them.

Procarbazine-induced hepatotoxicity: case report and review of the literature.

PubMed

Fesler, Mark J; Becker-Koepke, Stephanie; Di Bisceglie, Adrian M; Petruska, Paul J

2010-05-01

Procarbazine hydrochloride is an oral alkylating agent primarily used as a component of chemotherapy regimens for Hodgkin's lymphoma, as well as in regimens for primary central nervous system lymphoma and high-grade gliomas. Although the prescribing information for procarbazine lists hepatic dysfunction as a potential adverse reaction, we found only one published report with a probable link between procarbazine and liver injury. We describe a 65-year-old man who developed liver injury due to procarbazine during salvage chemotherapy for non-Hodgkin's lymphoma. The patient had no preexisting liver disease, his lymphoma was without hepatic involvement, and no liver injury developed after initial chemotherapy with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone). Due to relapse of his non-Hodgkin's lymphoma, salvage chemotherapy with C-MOPP-R (cyclophosphamide, vincristine, procarbazine, prednisone, and rituximab) was administered, and the patient developed fever and aminotransferase level elevation during the second cycle. After discontinuation of all drug therapy, exclusion of other potential etiologies, and resolution of hepatic injury, the patient was rechallenged with procarbazine and again experienced fever with aminotransferase level elevation. His aminotransferase levels promptly returned to normal after discontinuation of procarbazine, and he experienced no further evidence of liver disease. Use of validated scoring systems of drug-induced liver injury indicated a definitive association between the patient's hepatic injury and procarbazine. Based on our experience with this patient, periodic assessment of hepatic function, as suggested in the package insert, is recommended in patients receiving procarbazine.

Severe abnormal behavior incidence after administration of neuraminidase inhibitors using the national database of medical claims.

PubMed

Nakamura, Yuuki; Sugawara, Tamie; Ohkusa, Yasushi; Taniguchi, Kiyosu; Miyazaki, Chiaki; Momoi, Mariko; Okabe, Nobuhiko

2018-03-01

An earlier study using the number of abnormal behaviors reported to the study group as the numerator and the number of influenza patient prescribed each neuraminidase inhibitor (NI) estimated by respective pharmaceutical companies found no significant difference among incidence rates of the most severe abnormal behaviors by type of NI throughout Japan. However, the dataset for the denominator used in that earlier study was the estimated number of prescriptions. In the present study, to compare the incidence rates of abnormal behavior more precisely among influenza patients administered several sorts of NI or administered no NI, we used data obtained from the National Database of Electronic Medical Claims (NDBEMC) as the denominator to reach a definitive conclusion. Results show that patients not administered any NI (hereinafter un-administered) or those administered peramivir sometimes showed higher risk of abnormal behavior than those administered oseltamivir, zanamivir, or laninamivir. However, the un-administered or peramivir patients were fewer than those taking other NI. Therefore, accumulation of data through continued research is expected to be necessary to reach a definitive conclusion about the relation between abnormal behavior and NI in influenza patients. Since severe abnormal behaviors with all types of NI or of un-administered patients have been reported, there are some risks in the administration of NI or even in un-administered cases. Therefore, we infer that the policy mandating package inserts in all types of NI. Copyright © 2017. Published by Elsevier Ltd.

Magnetic thermometry in the aseptic processing of foods containing particulates (abstract)

NASA Astrophysics Data System (ADS)

Ghiron, Kenneth; Litchfield, Bruce

1997-04-01

Aseptic processing of foods has many advantages over canning, including higher efficiency, lighter packaging, better taste, and higher nutritional value. Aseptic processing is different from canning where the food and container are sterilized together. Instead, a thin stream of food is heated and the packaging is independently sterilized before the food is placed in the package. However, no aseptic processes have been successfully filed with the FDA for foods containing sizable solid particles because of uncertainties in the thermal sterilization of the particles (e.g., soup). We have demonstrated that by inserting small paramagnetic particles in the interior of the simulated and real food particles, the local temperature can be measured. With this information, any questions about the adequate sterilization of the particles can be resolved. The measurements were done by directing the food stream through a magnetic field and sensing the voltages induced in a pickup coil by the motion of the magnetized particles. Details of the equipment design and data analysis will be discussed along with an introduction to the aseptic processing of foods.

C1 lateral mass screw-induced occipital neuralgia: a report of two cases.

PubMed

Conroy, Eimear; Laing, Alan; Kenneally, Rory; Poynton, A R

2010-03-01

C1-2 polyaxial screw-rod fixation is a relatively new technique. While recognizing the potential for inadvertent vertebral artery injury, there have been few reports in the literature outlining all the possible complications. Aim of this study is to review all cases of C1 lateral mass screws insertion with emphasis on the evaluation of potential structures at risk during the procedure. We retrospectively reviewed all patients in our unit who had C1 lateral mass screw insertion over a 2-year period. The C1 lateral mass screw was inserted as part of an atlantoaxial stabilization or incorporated into a modular occiput/subaxial construct. Outcome measures included clinical and radiological parameters. Clinical indicators included age, gender, neurologic status, surgical indication and the number of levels stabilized. Intraoperative complications including blood loss, vertebral artery injury or dural tears were recorded. Postoperative pain distribution and neurological deficit were recorded. Radiological indicators included postoperative plain radiographs to assess sagittal alignment and to check for screw malposition or construct failure. A total of 18 lateral mass screws were implanted in 9 patients. There were three male and six female patients who had C1 lateral mass screw insertion in this unit. Two patients had atlantoaxial stabilization for C2 fracture. There were four patients with rheumatoid arthritis whose C1 lateral mass screws were inserted as part of an occipitocervical or subaxial cervical stabilization. There was no vertebral artery injury, no cerebrospinal fluid leak and minimal blood loss in all patients. Three patients developed postoperative occipital neuralgia. This neuralgia was transient, in one of the patients having settled at 6-week follow-up. In the other two patients the neuralgia was unresolved at time of latest follow-up but was adequately controlled with appropriate pain management. Postoperatively no patient had radiographic evidence of construct failure and all demonstrated excellent sagittal alignment. It has been reported that the absence of threads on the upper portion of the long shank screw may protect against neural irritation. However, insertion of the C1 lateral mass screw necessitates careful caudal retraction of the C2 dorsal root ganglion. The insertion point for the C1 lateral mass screw is at the junction of the C1 posterior arch and the midpoint of the posterior inferior part of the C1 lateral mass. Two patients in our series suffered occipital neuralgia post-insertion of C1 lateral mass screws. This highlights the potential for damage to the C2 nerve root during C1 lateral mass screw placement.

C1 lateral mass screw-induced occipital neuralgia: a report of two cases

PubMed Central

Laing, Alan; Kenneally, Rory; Poynton, A. R.

2009-01-01

C1–2 polyaxial screw-rod fixation is a relatively new technique. While recognizing the potential for inadvertent vertebral artery injury, there have been few reports in the literature outlining all the possible complications. Aim of this study is to review all cases of C1 lateral mass screws insertion with emphasis on the evaluation of potential structures at risk during the procedure. We retrospectively reviewed all patients in our unit who had C1 lateral mass screw insertion over a 2-year period. The C1 lateral mass screw was inserted as part of an atlantoaxial stabilization or incorporated into a modular occiput/subaxial construct. Outcome measures included clinical and radiological parameters. Clinical indicators included age, gender, neurologic status, surgical indication and the number of levels stabilized. Intraoperative complications including blood loss, vertebral artery injury or dural tears were recorded. Postoperative pain distribution and neurological deficit were recorded. Radiological indicators included postoperative plain radiographs to assess sagittal alignment and to check for screw malposition or construct failure. A total of 18 lateral mass screws were implanted in 9 patients. There were three male and six female patients who had C1 lateral mass screw insertion in this unit. Two patients had atlantoaxial stabilization for C2 fracture. There were four patients with rheumatoid arthritis whose C1 lateral mass screws were inserted as part of an occipitocervical or subaxial cervical stabilization. There was no vertebral artery injury, no cerebrospinal fluid leak and minimal blood loss in all patients. Three patients developed postoperative occipital neuralgia. This neuralgia was transient, in one of the patients having settled at 6-week follow-up. In the other two patients the neuralgia was unresolved at time of latest follow-up but was adequately controlled with appropriate pain management. Postoperatively no patient had radiographic evidence of construct failure and all demonstrated excellent sagittal alignment. It has been reported that the absence of threads on the upper portion of the long shank screw may protect against neural irritation. However, insertion of the C1 lateral mass screw necessitates careful caudal retraction of the C2 dorsal root ganglion. The insertion point for the C1 lateral mass screw is at the junction of the C1 posterior arch and the midpoint of the posterior inferior part of the C1 lateral mass. Two patients in our series suffered occipital neuralgia post-insertion of C1 lateral mass screws. This highlights the potential for damage to the C2 nerve root during C1 lateral mass screw placement. PMID:19856190

Heparin pharmacovigilance in Brazil.

PubMed

Junqueira, Daniela Rezende Garcia; Viana, Thércia Guedes; Peixoto, Eliane R de M; Barros, Fabiana C R de; Carvalho, Maria das Graças; Perini, Edson

2011-01-01

To investigate the biological origin of injectable unfractioned heparin available in Brazilian market by discussing the impact of the profile of commercial products and the changes in heparin monograph on the drug safety. The Anvisa data base for the Registered Products of Pharmaceutical Companies and the Dictionary of Pharmaceutical Specialties (DEF 2008/2009) were searched. A survey with industries having an active permission for marketing the drug in Brazil was conducted. Five companies were granted a permission to market unfractioned heparin in Brazil. Three of them are porcine in origin and two of them are bovine in origin, with only one explicitly showing this information in the package insert. The effectiveness and safety of heparin studied in non-Brazilian populations may not represent the Brazilian reality, since most countries no longer produce bovine heparin. The currently marketed heparin has approximately 10% less anticoagulant activity than that previously produced and this change may have clinical implications. Evidence about the lack of dose interchangeability between bovine and porcine heparins and the unique safety profile of these drugs indicates the need to follow the treatment and the patients' response. Events threatening the patient's safety must be reported to the pharmacovigilance system in each particular country.

Prospective comparison of two management strategies of central venous catheters in burn patients.

PubMed

Kealey, G P; Chang, P; Heinle, J; Rosenquist, M D; Lewis, R W

1995-03-01

Central venous catheters (CVCs) are associated with sepsis in burn patients. This study was undertaken to compare two strategies of CVC management in patients with major burn injuries. Forty-two burn patients with major burn injuries were randomly assigned to undergo site change every 48 hours of the CVC or to undergo wire guide exchange of the CVC every 48 hours at the same site. Catheter insertion site, distance from the burn wound, cultures of catheter tips, and blood cultures were obtained from all patients in a prospective manner. There was no difference in the incidence of CVC sepsis between the two groups studied. CVCs inserted less than 5 cm from the burn wound developed bacterial contamination at an earlier time than CVCs inserted more than 5 cm from the burn wound. There was no advantage to changing the CVC insertion site every 48 hours. Changing the CVC using the wire guide technique did not prevent, nor predict, CVC bacterial contamination.

GEMINI-TITAN (GT)-XI - MISC. EXPERIMENTS - MSC

NASA Image and Video Library

1966-03-22

S66-05515 (2 June 1966) --- Gemini-11 Experiment S-9 Nuclear Emulsion. This experiment will be used to study the cosmic radiation incident on Earth's atmosphere, to obtain detailed chemical composition of the heavy primary nuclei and to search for rare particles. Equipment is a rectangular package eight and a half by six by three inches weighing 15 pounds and including the nuclear emulsion film stack, motor to advance the emulsion and a timer to regulate the motor. The package is mounted atop the spacecraft retro adapter section prior to launch, is activated at insertion, and is retrieved by the EVA pilot. The experiment is conducted with the spacecraft in plus or minus 15 degrees of Earth's average magnetic field vector. Sponsors are NASA's Office of Space Science and Applications and the U.S. Naval Research Laboratories. Photo credit: NASA

Autonomous microexplosives subsurface tracing system final report.

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

Engler, Bruce Phillip; Nogan, John; Melof, Brian Matthew

The objective of the autonomous micro-explosive subsurface tracing system is to image the location and geometry of hydraulically induced fractures in subsurface petroleum reservoirs. This system is based on the insertion of a swarm of autonomous micro-explosive packages during the fracturing process, with subsequent triggering of the energetic material to create an array of micro-seismic sources that can be detected and analyzed using existing seismic receiver arrays and analysis software. The project included investigations of energetic mixtures, triggering systems, package size and shape, and seismic output. Given the current absence of any technology capable of such high resolution mapping ofmore » subsurface structures, this technology has the potential for major impact on petroleum industry, which spends approximately $1 billion dollar per year on hydraulic fracturing operations in the United States alone.« less

Significance of the Pars Interarticularis in the Cortical Bone Trajectory Screw Technique: An In Vivo Insertional Torque Study.

PubMed

Ninomiya, Koshi; Iwatsuki, Koichi; Ohnishi, Yu-Ichiro; Ohkawa, Toshika; Yoshimine, Toshiki

2016-10-01

Retrospective study. Cortical bone trajectory (CBT), a more medial-to-lateral and shorter path than the traditional one for spinal fusion, is thought to be effective for severely degenerated vertebrae because screws are primarily stabilized at the posterior elements. We evaluated the efficacy of this approach through in vivo insertional torque measurement. There has been only one prior in vivo study on CBT insertional torque. Between January 2013 and April 2014, a total of 22 patients underwent posterior lumbar fusion using the CBT technique. The maximum insertional torque, which covers the radial strength needed for insertion, was measured for 113 screws, 8 of which were inserted for L5 spondylolysis. The insertional torque for cases with (n=8) and without (n=31) spondylolysis of L5 were compared using one-way analysis of variance (ANOVA). To evaluate vertebral degeneration, we classified 53 vertebrae without spondylolysis by lumbar radiography using semiquantitative methods; the insertional torque for the 105 screws used was compared on the basis of this classification. Additionally, differences in insertional torque among cases grouped by age, sex, and lumbar level were evaluated for these 105 screws using ANOVA and the Tukey test. The mean insertional torque was significantly lower for patients with spondylolysis than for those without spondylolysis (4.25 vs. 8.24 in-lb). There were no statistical differences in insertional torque according to vertebral grading or level. The only significant difference in insertional torque between age and sex groups was in men <75 years and women ≥75 years (10 vs. 5.5 in-lb). Although CBT should be used with great caution in patient with lysis who are ≥75 years, it is well suited for dealing with severely degenerated vertebrae because the pars interarticularis plays a very important role in the implementation of this technique.

Patient assessment within the context of healthcare delivery packages: A comparative analysis.

PubMed

Rossen, Camilla Blach; Buus, Niels; Stenager, Egon; Stenager, Elsebeth

2016-01-01

Due to an increased focus on productivity and cost-effectiveness, many countries across the world have implemented a variety of tools for standardizing diagnostics and treatment. In Denmark, healthcare delivery packages are increasingly used for assessment of patients. A package is a tool for creating coordination, continuity and efficient pathways; each step is pre-booked, and the package has a well-defined content within a predefined category of diseases. The aim of this study was to investigate how assessment processes took place within the context of healthcare delivery packages. The study used a constructivist Grounded Theory approach. Ethnographic fieldwork was carried out in three specialized units: a mental health unit and two multiple sclerosis clinics in Southern Denmark, which all used assessment packages. Several types of data were sampled through theoretical sampling. Participant observation was conducted for a total of 126h. Formal and informal interviews were conducted with 12 healthcare professionals and 13 patients. Furthermore, audio recordings were made of 9 final consultations between physicians and patients; 193min of recorded consultations all in all. Lastly, the medical records of 13 patients and written information about packages were collected. The comparative, abductive analysis focused on the process of assessment and the work made by all the actors involved. In this paper, we emphasized the work of healthcare professionals. We constructed five interrelated categories: 1. "Standardized assessing", 2. "Flexibility", which has two sub-categories, 2.1. "Diagnostic options" and 2.2. "Time and organization", and, finally, 3. "Resisting the frames". The process of assessment required all participants to perform the predefined work in the specified way at the specified time. Multidisciplinary teamwork was essential for the success of the process. The local organization of the packages influenced the assessment process, most notably the pre-defined scope of relevant diseases targeted by the package. The inflexible frames of the assessment package could cause resistance among clinicians. Moreover, expert knowledge was an important factor for the efficiency of the process. Some types of organizational work processes resulted in many patients being assessed, but without being diagnosed with at package-relevant disease. Limiting the grounds for using specialist knowledge in structured health care delivery may affect specialists' sense of professional autonomy and can result in professionals employing strategies to resist the frames of the packages. Finally, when organizing healthcare delivery packages, it seems important to consider how to make the optimal use of specialist knowledge. Copyright © 2015 Elsevier Ltd. All rights reserved.

Predicting the failure of retrograde ureteral stent insertion for managing malignant ureteral obstruction in outpatients

PubMed Central

WANG, JIN-YOU; ZHANG, HAI-LIANG; ZHU, YAO; QIN, XIAO-JIAN; DAI, BO; YE, DING-WEI

2016-01-01

Malignant ureteral obstruction (MUO) is an unpropitious sign that is commonly observed in patients with advanced incurable cancer. The present study aimed to evaluate predictive factors for the failure of retrograde ureteral stent insertion in the management of MUO in outpatients. A total of 164 patients with MUO were retrospectively assessed in this study. Clinical factors, including age, gender, type of malignancy, level of obstruction, cause of obstruction, pre-operative creatinine level, degree of hydronephrosis, condition of the contralateral ureter, prior radiotherapy, Eastern Cooperative Oncology Group performance status (ECOG PS), bladder wall invasion and technical failure, were recorded for each case. Univariate and multivariate logistic regression analyses were used to investigate the risk factors for predicting the failure of retrograde ureteral stent insertion. In total, 38 out of 164 patients experienced bilateral obstruction, therefore, a total of 202 ureteral units were available for data analysis. The rate of insertion failure in MUO was 34.65%. Multivariate analyses identified ECOG PS, degree of hydronephrosis and bladder wall invasion as independent predictors for insertion failure. Overall, the present study found that rate of retrograde ureteral stent insertion failure is high in outpatients with MUO, and that ECOG PS, degree of hydronephrosis and bladder invasion are potential independent predictors of insertion failure. PMID:26870299

Effect of dental wear, stabilization appliance and anterior tooth reconstruction on mandibular movements during speech.

PubMed

Serrano, Priscila de Oliveira; Faot, Fernanda; Del Bel Cury, Altair Antoninha; Rodrigues Garcia, Renata Cunha Matheus

2008-01-01

This study described changes in mandibular movements during pronunciation of /m/ and /s/ sounds in Portuguese, in patients presenting dental wear before and after appliance insertion and tooth reconstruction. Subjects were divided into a control group of dentate patients and an experimental group of patients with incisal tooth wear due to bruxism. A magnetic jaw tracking device measured the jaw opening, and translations to left and right sides of the mandible during pronunciation of phonemes. Evaluations were carried out 1 week and immediately before appliance insertion; 24 h, 7, 30 and 60 days after appliance insertion; and 1 week and 1 month after tooth reconstruction. Data were submitted to two-way ANOVA, Mann-Whitney and Friedman tests (p<0.05). Jaw opening was different (p<0.05) for both sounds in all periods. The anteroposterior amplitude for /s/ showed differences immediately before and 1 month after appliance insertion (p<0.05). Lateral amplitude for the right side showed differences between groups after appliance insertion for /s/, and 1 and 2 months after appliance insertion for the /m/ (p<0.05). Volunteers with anterior tooth wear had a wider opening movement, and the movements during speech of /m/ and /s/ sounds were not changed after appliance insertion and reconstruction of teeth.

New regimen for eccentric calf-muscle training in patients with chronic insertional Achilles tendinopathy: results of a pilot study.

PubMed

Jonsson, P; Alfredson, H; Sunding, K; Fahlström, M; Cook, J

2008-09-01

Chronic painful insertional Achilles tendinopathy is seen in both physically active and non-active individuals. Painful eccentric training, where the patients load the Achilles tendon into full dorsiflexion, has shown good results in patients with mid-portion Achilles tendinosis. However, only 32% of patients with insertional Achilles tendinopathy had good clinical results with that type of eccentric training regimen. To investigate whether a new model of painful eccentric training had an effect on chronic painful insertional Achilles tendinopathy. 27 patients (12 men, 15 women, mean age 53 years) with a total of 34 painful Achilles tendons with a long duration of pain (mean 26 months), diagnosed as insertional Achilles tendinopathy, were included. The patients performed a new model of painful eccentric training regimen without loading into dorsiflexion. This was done as 3x15 reps, twice a day, 7 days/week, for 12 weeks. Pain during Achilles-tendon-loading activity (VAS) and patient's satisfaction (back to previous activity) were evaluated. At follow-up (mean 4 months) 18 patients (67%, 23/34 tendons) were satisfied and back to their previous tendon-loading activity. Their mean VAS had decreased from 69.9 (SD 18.9) to 21 (SD 20.6) (p<0.001). Nine patients (11 tendons) were not satisfied with the treatment, although their VAS was significantly reduced from 77.5 (8.6) to 58.1 (14.8) (p<0.01). In this short-term pilot study this new model of painful eccentric calf-muscle training showed promising clinical results in 67% of the patients.

Pleural drainage and its role in management of the isolated penetrating chest injuries during the war time in Sarajevo, 1992.-1995.

PubMed

Hadzismajlović, Ademir; Pilav, Alen

2007-05-01

Penetrating chest injuries are the most frequent causes of serious demage and death in wounded indivisuals. In reports from the last wars where wounds caused by high velocity projectiles predominated, thoracotomies were perfomed in about 15% of the wounded individuals, mostly encompassing injuries of the heart and great vessels, accomanied by massive bleeding that could not be resolved by chest tube insertion. This retrospective analysis was performed on the medical records of 477 patients tretaed for isolated penetrating chest injuries in Department of Thoracic Surgery Clinical Center of the University in Sarajevo between april 1992 - june 1995. We analised the ways of their menagement with special view on pleural drainage, indication for this method and results of treatment. 398 (83,4%) wounded individuals have been treated with pleural tube inserting as definitive mesaure and for the urgent thoracotomy there were 79 (16,6%) patients left. Average hospital treatment in wounded drained patients was 7,68 days. With shrapnels there were 357 (74,84%) wounded individuals, and with bullet 120 (25,16%) wounded individuals. The complications of plaural tube inserting were - empyema in 34 (7,13%) patients and there were no other complications. Chest tube inserting as definitive mesaure was used in 398 (83,44%) patients. Chest tube inserting as preoperative measure (urgent thoracotomy) was used in 79 (16,56%) patients. There were 460 (96,44%) healed patients. Death occurred in 17 (3,56%) patients.

Comparison between gastrostomy feeding and self-expandable metal stent insertion for patients with esophageal cancer and dysphagia

PubMed Central

Jung, Ji Hey; Lee, Hyuk; Min, Byung-Hoon; Lee, Jun Haeng; Rhee, Poong-Lyul; Kim, Jae J.

2017-01-01

Background Self-expandable metal stent (SEMS) insertion and percutaneous gastrostomy (PG) feeding are commonly used for patients with esophageal cancer and dysphagia. This study aimed to compare outcomes between SEMS insertion and PG feeding for them. Methods We retrospectively analyzed 308 patients with esophageal cancer who underwent fully covered SEMS insertion (stent group) or PG (gastrostomy group) for dysphagia due to tumor. Patients with other causes of dysphagia, such as radiation-induced or postoperative stricture, were excluded from the study. Clinical outcomes were compared between the two groups, including overall survival and need for additional intervention and postprocedural nutritional status. Results At baseline, the stent group (n = 169) had more stage IV patients, less cervical cancers, and received radiotherapy and esophagectomy less often than the gastrostomy group (n = 64). The Kaplan-Meier curves showed higher overall survival in the gastrostomy group than in the stent group. Multivariate analysis revealed that PG was associated with better survival compared with SEMS insertion (hazard ratio 0.541, 95% confidence interval 0.346–0.848, p = 0.007). In addition, the gastrostomy group needed additional intervention less often (3.1% vs. 21.9%, p < 0.001) and experienced less decrease in serum albumin levels (-0.15 ± 0.56 g/dL vs. -0.39 ± 0.58 g/dL, p = 0.011) than the stent group after procedure. Conclusions Our data suggested that, compared with SEMS insertion, PG is associated with better overall survival in patients with esophageal cancer and dysphagia. Stabilized nutritional status by PG may play a role in improving patient survival. PMID:28632744

Comparative Study of Esophageal Self-expandable Metallic Stent Insertion and Gastrostomy Feeding for Dysphagia Caused by Lung Cancer.

PubMed

Kim, Jihye; Min, Yang Won; Lee, Hyuk; Min, Byung Hoon; Lee, Joon Haeng; Rhee, Poong Lyul; Kim, Jae J

2018-03-25

Dysphagia is encountered in a large proportion of patients with lung cancer and is associated with malnutrition and a poor quality of life. This study compared the clinical outcomes of self-expandable metallic stent (SEMS) insertion and percutaneous gastrostomy (PG) feeding for patients with lung cancer and dysphagia. A total of 261 patients with lung cancer, who underwent either SEMS insertion (stent group) or PG (gastrostomy group) as an initial treatment procedure for dysphagia between July 1997 and July 2015 at the Samsung Medical Center, were reviewed retrospectively, and 84 patients with esophageal obstruction were identified. The clinical outcomes, including the overall survival, additional intervention, complications, and post-procedural nutritional status in the two groups, were compared. Among the 84 patients finally analyzed, 68 patients received SEMS insertion and 16 had PG. The stent group had less cervical obstruction and more mid-esophageal obstruction than the gastrostomy group. The Kaplan-Meier curves revealed similar overall survival in the two groups. Multivariate analysis showed that the two modalities had similar survival rates (PG compared with SEMS insertion, hazard ratio 0.682, p=0.219). Fifteen patients (22.1%) in the stent group received additional intervention, whereas there was no case in the gastrostomy group (p=0.063). The decrease in the serum albumin level after the procedure was lower in the gastrostomy group than in the stent group (-0.20±0.54 g/dL vs. -0.65±0.57 g/dL, p=0.013). SEMS insertion and PG feeding for relieving dysphagia by lung cancer had a comparable survival outcome. On the other hand, PG was associated with a better nutritional status.

Determining Whether a Definitive Causal Relationship Exists Between Aripiprazole and Tardive Dyskinesia and/or Dystonia in Patients With Major Depressive Disorder, Part 2: Preclinical and Early Phase Human Proof of Concept Studies.

PubMed

Macaluso, Matthew; Flynn, Alexandra; Preskorn, Sheldon

2016-01-01

This series of columns has 3 main goals: (1) to explain class warnings as used by the United States Food and Drug Administration, (2) to increase awareness of movement disorders that may occur in patients treated with antipsychotic medications, and (3) to understand why clinicians should refrain from immediately assuming a diagnosis of tardive dyskinesia/dystonia (TD) in patients treated with antipsychotics. The first column in this series began with the case of a 76-year-old man with major depressive disorder who developed orofacial dyskinesias while being treated with aripiprazole as an antidepressant augmentation strategy. It was alleged that a higher than intended dose of aripiprazole (ie, 20 mg/d for 2 wk followed by 10 mg/d for 4 wk instead of the intended dose of 2 mg/d) was the cause of the dyskinetic movements in this man, and the authors were asked to review the case and give their opinion. The principal basis for this theory of causation was the class warning about TD in the package insert for aripiprazole. The rationale for concluding aripiprazole caused TD in the 76-year-old man led to this series of columns about aripiprazole, its potential--if any--to cause TD, and the presence of a class warning about TD in its package insert. The central point is to illustrate why class warnings exist and their implications for practice. The first column in this series focused on the historical background, incidence, prevalence, risk factors, and clinical presentations of tardive and spontaneous dyskinesias and concluded with a discussion of diagnostic considerations explaining why clinicians should avoid making a diagnosis of TD until a thorough differential diagnosis has been considered. This second column in the series reviews the pharmacology of aripiprazole and the preclinical and phase I translational human studies that suggest aripiprazole should have a low to nonexistent risk of causing TD compared with other antipsychotics. The third column in the series will review the systematic clinical trial data and "real-world" data on TD and the use of aripiprazole as adjunctive treatment with antidepressants for major depressive disorder to see whether these data support the conclusion of a low to nonexistent relationship between aripiprazole treatment and the development of TD. The fourth and final column in the series will consider the type of study that would need to be performed to avoid a specific class warning, focusing on the TD class warning as an example and discussing why such studies are rarely done.

Rupture of the anterior tibial tendon: three clinical cases, anatomical study, and literature review.

PubMed

Anagnostakos, Konstantinos; Bachelier, Felix; Fürst, Oliver Alexander; Kelm, Jens

2006-05-01

We report three cases of anterior tibial tendon ruptures and the results of an anatomical study in regard to the tendon's insertion site and a literature review. Three patients were referred to our hospital with anterior tibial tendon ruptures. In the anatomical study, 53 feet were dissected, looking in particular for variants of the bony insertion of the tendon. Two patients had surgical treatment (one primary repair and one semimembranosus tendon graft) and one conservative treatment. After a mean followup of 14 weeks all patients had satisfactory outcomes. In the anatomical study, we noted three different insertion sites: in 36 feet the tendon inserted into the medial side of the cuneiform and the base of the first metatarsal bone and in 13 feet only into the medial side of the cuneiform bone. In the remaining four feet the tendon inserted into the cuneiform and the first metatarsal bone, but an additional tendon was noted taking its origin from the anterior tibial tendon near its insertion into the medial cuneiform and attaching to the proximal part of the first metatarsal. According to literature, surgical repair is the treatment of choice for acute ruptures and for patients with high activity levels. For chronic ruptures and patients with low demands, conservative management may lead to an equally good outcome. Knowledge of the anatomy in this region may be helpful for diagnosis and for the interpretation of intraoperative findings and choosing the most appropriate surgical procedure.

Patient-specific simulation of guidewire deformation during transcatheter aortic valve implantation.

PubMed

Vy, Phuoc; Auffret, Vincent; Castro, Miguel; Badel, Pierre; Rochette, Michel; Haigron, Pascal; Avril, Stéphane

2018-06-01

Transcatheter aortic valve implantation is a recent mini-invasive procedure to implant an aortic valve prosthesis. Prosthesis positioning in transcatheter aortic valve implantation appears as an important aspect for the success of the intervention. Accordingly, we developed a patient-specific finite element framework to predict the insertion of the stiff guidewire, used to position the aortic valve. We simulated the guidewire insertion for 2 patients based on their pre-operative CT scans. The model was designed to primarily predict the position and the angle of the guidewires in the aortic valve, and the results were successfully compared with intraoperative images. The present paper describes extensively the numerical model, which was solved by using the ANSYS software with an implicit resolution scheme, as well as the stabilization techniques which were used to overcome numerical instabilities. We performed sensitivity analysis on the properties of the guidewire (curvature angle, curvature radius, and stiffness) and the conditions of insertion (insertion force and orientation). We also explored the influence of the model parameters. The accuracy of the model was quantitatively evaluated as the distance and the angle difference between the simulated guidewires and the intraoperative ones. A good agreement was obtained between the model predictions and intraoperative views available for 2 patient cases. In conclusion, we showed that the shape of the guidewire in the aortic valve was mainly determined by the geometry of the patient's aorta and by the conditions of insertion (insertion force and orientation). Copyright © 2018 John Wiley & Sons, Ltd.

Comparison of custom and prefabricated orthoses in the initial treatment of proximal plantar fasciitis.

PubMed

Pfeffer, G; Bacchetti, P; Deland, J; Lewis, A; Anderson, R; Davis, W; Alvarez, R; Brodsky, J; Cooper, P; Frey, C; Herrick, R; Myerson, M; Sammarco, J; Janecki, C; Ross, S; Bowman, M; Smith, R

1999-04-01

Fifteen centers for orthopaedic treatment of the foot and ankle participated in a prospective randomized trial to compare several nonoperative treatments for proximal plantar fasciitis (heel pain syndrome). Included were 236 patients (160 women and 76 men) who were 16 years of age or older. Most reported duration of symptoms of 6 months or less. Patients with systemic disease, significant musculoskeletal complaints, sciatica, or local nerve entrapment were excluded. We randomized patients prospectively into five different treatment groups. All groups performed Achilles tendon- and plantar fascia-stretching in a similar manner. One group was treated with stretching only. The other four groups stretched and used one of four different shoe inserts, including a silicone heel pad, a felt pad, a rubber heel cup, or a custom-made polypropylene orthotic device. Patients were reevaluated after 8 weeks of treatment. The percentages improved in each group were: (1) silicone insert, 95%; (2) rubber insert, 88%; (3) felt insert, 81%; (4)stretching only, 72%; and (5) custom orthosis, 68%. Combining all the patients who used a prefabricated insert, we found that their improvement rates were higher than those assigned to stretching only (P = 0.022) and those who stretched and used a custom orthosis (P = 0.0074). We conclude that, when used in conjunction with a stretching program, a prefabricated shoe insert is more likely to produce improvement in symptoms as part of the initial treatment of proximal plantar fasciitis than a custom polypropylene orthotic device.

Laparoscopic salpingectomy and removal of Essure hysteroscopic sterilisation device: a case series.

PubMed

Johal, T; Kuruba, N; Sule, M; Mukhopadhyay, S; Raje, G

2018-06-01

Tubal sterilisation using Essure is a minimally invasive technique for permanent contraception, with high rates of patient satisfaction. However, some women subsequently choose removal of the inserts, due to side effects such as pelvic pain, abnormal bleeding, dyspareunia or allergic dermatitis. This case series presents the management of eight women who underwent laparoscopic removal of Essure inserts in conjunction with salpingectomy. We describe our surgical technique, its underlying principles and immediate surgical outcomes. Eight patients were identified as having undergone removal of Essure inserts, via an electronic search of the surgical procedures database. A retrospective review of case records was undertaken. The primary outcome was safety and feasibility of the laparoscopic salpingectomy approach. Secondary outcome measures included implant fracture rate, operative time, blood loss and length of patient stay. All eight women were able to undergo laparoscopic salpingectomy and removal of the Essure inserts without the need for laparotomy or hysterectomy. There were no incidences of fracture or incomplete removal of the insert. Immediate postoperative recovery was uncomplicated in all eight women; the mean length of stay was 17 h. One patient had a small bowel serosal tear attributed to laparoscopic entry. This case series suggests that laparoscopic salpingectomy for removal of Essure inserts is safe and feasible. We acknowledge that the numbers were small. However, consistent use of a laparoscopic approach in these eight patients indicates that this procedure is a feasible and suitable alternative to hysterectomy.

Problems experienced by older people when opening medicine packaging.

PubMed

Philbert, Daphne; Notenboom, Kim; Bouvy, Marcel L; van Geffen, Erica C G

2014-06-01

Medicine packages can cause problems in daily practice, especially among older people. This study aimed to investigate the prevalence of problems experienced by older people when opening medicine packaging and to investigate how patients manage these problems. A convenience sample of 30 community pharmacies participated in this study. They selected a systematic sample of 30 patients over 65 years old with a recent omeprazole prescription, and a questionnaire was administered by telephone for at least 10 patients per pharmacy. A total of 317 patients completed the questionnaire. They received their omeprazole in a bottle (n = 179, 56.5%), push-through blister pack (n = 102, 32.2%) or peel-off blister pack (n = 36, 11.4%). Some 28.4% of all patients experienced one or more problems with opening their omeprazole packaging; most problems occurred with peel-off blisters (n = 24, 66.7% of all respondents using peel-off blisters), followed by push-through blisters (n = 34, 33.3%) and finally bottles (n = 32, 17.9%). The risk of experiencing problems with peel-off blisters and push-through blisters was higher [relative risk 3.7 (95% confidence interval 2.5-5.5) and 1.9 (1.2-2.8), respectively] than the risk of experiencing problems with opening bottles. Two-thirds of respondents reported management strategies for their problems. Most were found for problems opening bottles (n = 24, 75%), followed by push-through blisters (n = 24, 70.6%) and peel-off blisters (n = 14, 58.3%). One in four patients over 65 experienced difficulties opening their omeprazole packaging and not all of them reported a management strategy for their problems. Manufacturers are advised to pay more attention to the user-friendliness of product packaging. In addition, it is important that pharmacy staff clearly instruct patients on how to open their medicine packaging, or assist them in choosing the most appropriate packaging. © 2013 Royal Pharmaceutical Society.

Recurrence, submicroscopic complexity, and potential clinical relevance of copy gains detected by array CGH that are shown to be unbalanced insertions by FISH.

PubMed

Neill, Nicholas J; Ballif, Blake C; Lamb, Allen N; Parikh, Sumit; Ravnan, J Britt; Schultz, Roger A; Torchia, Beth S; Rosenfeld, Jill A; Shaffer, Lisa G

2011-04-01

Insertions occur when a segment of one chromosome is translocated and inserted into a new region of the same chromosome or a non-homologous chromosome. We report 71 cases with unbalanced insertions identified using array CGH and FISH in 4909 cases referred to our laboratory for array CGH and found to have copy-number abnormalities. Although the majority of insertions were non-recurrent, several recurrent unbalanced insertions were detected, including three der(Y)ins(Y;18)(q?11.2;p11.32p11.32)pat inherited from parents carrying an unbalanced insertion. The clinical significance of these recurrent rearrangements is unclear, although the small size, limited gene content, and inheritance pattern of each suggests that the phenotypic consequences may be benign. Cryptic, submicroscopic duplications were observed at or near the insertion sites in two patients, further confounding the clinical interpretation of these insertions. Using FISH, linear amplification, and array CGH, we identified a 126-kb duplicated region from 19p13.3 inserted into MECP2 at Xq28 in a patient with symptoms of Rett syndrome. Our results demonstrate that although the interpretation of most non-recurrent insertions is unclear without high-resolution insertion site characterization, the potential for an otherwise benign duplication to result in a clinically relevant outcome through the disruption of a gene necessitates the use of FISH to determine whether copy-number gains detected by array CGH represent tandem duplications or unbalanced insertions. Further follow-up testing using techniques such as linear amplification or sequencing should be used to determine gene involvement at the insertion site after FISH has identified the presence of an insertion.

Facial asymmetry and clinical manifestations in patients with novel insertion of the TCOF1 gene.

PubMed

Su, P-H; Liu, Y-F; Yu, J-S; Chen, J-Y; Chen, S-J; Lai, Y-J

2012-11-01

This study explored the role of TCOF1 insertion mutations in Taiwanese patients with craniofacial anomalies. Twelve patients with single or multiple, asymmetrical congenital craniofacial anomalies were enrolled. Genomic DNA was prepared from leukocytes; the coding regions of TCOF1 were analyzed by polymerase chain reaction and direct sequencing. Clinical manifestations were correlated to the TCOF1 mutation. Six of 12 patients diagnosed with hemifacial microsomia exhibited a novel insertion mutation 4127 ins G (frameshift) in exon 24 in the TCOF1 gene. All six patients were diagnosed with anomalies on the left side. In addition, four of these six patients had hearing impairment; three had other major anomalies; and two had developmental delay. The insertion caused a frameshift, an early truncation, the loss of two putative nuclear localization signals (residues 1404-1420 and 1424-1440), and the loss of coiled coil domain (1406-1426) in treacle protein. These findings support the existence of two regulators of growth of the mandibular condyles. © 2011 John Wiley & Sons A/S.

Corneal epithelial cell biocompatibility to silicone hydrogel and conventional hydrogel contact lens packaging solutions

PubMed Central

Tanti, N.C.; Jones, L.; Sheardown, H.

2010-01-01

Purpose Although all contact lenses (CLs) are applied initially to the eye directly from a packaging solution, little is known about the effects of these solutions on human corneal epithelial cells (HCECs). Due to the porous nature of CL materials, they have the potential to sorb components of the packaging solution during storage, which could then be subsequently released upon insertion of the CL on the eye. The purpose of this study was to investigate the effect of various packaging solutions on HCECs, using an in vitro model. Methods An in vitro assay was developed whereby various silicone hydrogels and conventional, poly-2-hydroxyethylmethacrylate  (polyHEMA)-based lens materials were removed directly from their packaging and then incubated for up to 24 h with HCECs. The effect of the retained and released packaging solution components on HCECs was assessed by measuring cell viability, adhesion phenotype, and apoptosis. Results Incubation of HCECs with CLs stored in borate-buffered packaging solutions resulted in a significant reduction in cell viability. Adherent cells incubated with these CLs also exhibited reduced levels of β1 and α3 integrin. Soaking borate-buffered packaged CLs in PBS before cell incubation resolved viability and integrin expression in all cases, with the exception of galyfilcon A and balafilcon A, from which a 20% reduction in cell viability was still observed. In comparison, CLs stored in phosphate-buffered packaging solutions had cellular viability and expression of integrins similar to control cells (cells incubated in the absence of a lens). When incubated with cells at a 10% concentration in serum-free medium, borate-buffered packaging solutions and borate-containing saline (Unisol 4) significantly reduced cell viability and integrin expression. Neither caspase activation nor annexin V binding was observed on cells following exposure to borate buffer solution. However, a significant decrease in reactive oxygen species was observed at 24 h. These latter results suggest that in vitro exposure to low concentration of borate/boric acid results in cell dysfunction, leading to necrosis rather than apoptosis. Conclusions Borate-buffered packaging solutions were shown to adversely affect the viability and integrin expression of HCECs in vitro. When used in ophthalmic packaging solutions, the antimicrobial properties of borate buffer may be outweighed by its relatively cytotoxic effects on cells. PMID:20169012

Corneal epithelial cell biocompatibility to silicone hydrogel and conventional hydrogel contact lens packaging solutions.

PubMed

Gorbet, M B; Tanti, N C; Jones, L; Sheardown, H

2010-02-19

Although all contact lenses (CLs) are applied initially to the eye directly from a packaging solution, little is known about the effects of these solutions on human corneal epithelial cells (HCECs). Due to the porous nature of CL materials, they have the potential to sorb components of the packaging solution during storage, which could then be subsequently released upon insertion of the CL on the eye. The purpose of this study was to investigate the effect of various packaging solutions on HCECs, using an in vitro model. An in vitro assay was developed whereby various silicone hydrogels and conventional, poly-2-hydroxyethylmethacrylate (polyHEMA)-based lens materials were removed directly from their packaging and then incubated for up to 24 h with HCECs. The effect of the retained and released packaging solution components on HCECs was assessed by measuring cell viability, adhesion phenotype, and apoptosis. Incubation of HCECs with CLs stored in borate-buffered packaging solutions resulted in a significant reduction in cell viability. Adherent cells incubated with these CLs also exhibited reduced levels of beta(1) and alpha(3) integrin. Soaking borate-buffered packaged CLs in PBS before cell incubation resolved viability and integrin expression in all cases, with the exception of galyfilcon A and balafilcon A, from which a 20% reduction in cell viability was still observed. In comparison, CLs stored in phosphate-buffered packaging solutions had cellular viability and expression of integrins similar to control cells (cells incubated in the absence of a lens). When incubated with cells at a 10% concentration in serum-free medium, borate-buffered packaging solutions and borate-containing saline (Unisol 4) significantly reduced cell viability and integrin expression. Neither caspase activation nor annexin V binding was observed on cells following exposure to borate buffer solution. However, a significant decrease in reactive oxygen species was observed at 24 h. These latter results suggest that in vitro exposure to low concentration of borate/boric acid results in cell dysfunction, leading to necrosis rather than apoptosis. Borate-buffered packaging solutions were shown to adversely affect the viability and integrin expression of HCECs in vitro. When used in ophthalmic packaging solutions, the antimicrobial properties of borate buffer may be outweighed by its relatively cytotoxic effects on cells.

Medical-grade honey does not reduce skin colonization at central venous catheter-insertion sites of critically ill patients: a randomized controlled trial

PubMed Central

2012-01-01

Introduction Catheter-related bloodstream infections (CRBSIs) associated with short-term central venous catheters (CVCs) in intensive care unit (ICU) patients are a major clinical problem. Bacterial colonization of the skin at the CVC insertion site is an important etiologic factor for CRBSI. The aim of this study was to assess the efficacy of medical-grade honey in reducing bacterial skin colonization at insertion sites. Methods A prospective, single-center, open-label randomized controlled trial was performed at the ICU of a university hospital in The Netherlands to assess the efficacy of medical-grade honey to reduce skin colonization of insertion sites. Medical-grade honey was applied in addition to standard CVC-site dressing and disinfection with 0.5% chlorhexidine in 70% alcohol. Skin colonization was assessed on a daily basis before CVC-site disinfection. The primary end point was colonization of insertion sites with >100 colony-forming units at the last sampling before removal of the CVC or transfer of the patient from the ICU. Secondary end points were quantitative levels of colonization of the insertion sites and colonization of insertion sites stratified for CVC location. Results Colonization of insertion sites was not affected by the use of medical-grade honey, as 44 (34%) of 129 and 36 (34%) of 106 patients in the honey and standard care groups, respectively, had a positive skin culture (P = 0.98). Median levels of skin colonization at the last sampling were 1 (0 to 2.84) and 1 (0 to 2.70) log colony-forming units (CFUs)/swab for the honey and control groups, respectively (P = 0.94). Gender, days of CVC placement, CVC location, and CVC type were predictive for a positive skin culture. Correction for these variables did not change the effect of honey on skin-culture positivity. Conclusions Medical-grade honey does not affect colonization of the skin at CVC insertion sites in ICU patients when applied in addition to standard disinfection with 0.5% chlorhexidine in 70% alcohol. Trial registration Netherlands Trial Registry, NTR1652. PMID:23111148

Medical-grade honey does not reduce skin colonization at central venous catheter-insertion sites of critically ill patients: a randomized controlled trial.

PubMed

Kwakman, Paulus H; Müller, Marcella C; Binnekade, Jan M; van den Akker, Johannes P; de Borgie, Corianne A; Schultz, Marcus J; Zaat, Sebastian A

2012-10-30

Catheter-related bloodstream infections (CRBSIs) associated with short-term central venous catheters (CVCs) in intensive care unit (ICU) patients are a major clinical problem. Bacterial colonization of the skin at the CVC insertion site is an important etiologic factor for CRBSI. The aim of this study was to assess the efficacy of medical-grade honey in reducing bacterial skin colonization at insertion sites. A prospective, single-center, open-label randomized controlled trial was performed at the ICU of a university hospital in The Netherlands to assess the efficacy of medical-grade honey to reduce skin colonization of insertion sites. Medical-grade honey was applied in addition to standard CVC-site dressing and disinfection with 0.5% chlorhexidine in 70% alcohol. Skin colonization was assessed on a daily basis before CVC-site disinfection. The primary end point was colonization of insertion sites with >100 colony-forming units at the last sampling before removal of the CVC or transfer of the patient from the ICU. Secondary end points were quantitative levels of colonization of the insertion sites and colonization of insertion sites stratified for CVC location. Colonization of insertion sites was not affected by the use of medical-grade honey, as 44 (34%) of 129 and 36 (34%) of 106 patients in the honey and standard care groups, respectively, had a positive skin culture (P = 0.98). Median levels of skin colonization at the last sampling were 1 (0 to 2.84) and 1 (0 to 2.70) log colony-forming units (CFUs)/swab for the honey and control groups, respectively (P = 0.94). Gender, days of CVC placement, CVC location, and CVC type were predictive for a positive skin culture. Correction for these variables did not change the effect of honey on skin-culture positivity. Medical-grade honey does not affect colonization of the skin at CVC insertion sites in ICU patients when applied in addition to standard disinfection with 0.5% chlorhexidine in 70% alcohol. Netherlands Trial Registry, NTR1652.

Use of biliary stent in laparoscopic common bile duct exploration.

PubMed

Lyon, Matthew; Menon, Seema; Jain, Abhiney; Kumar, Harish

2015-05-01

It is well supported in the literature that laparoscopic common bile duct exploration (LCBDE) for choledocholithiasis has equal efficacy when compared to ERCP followed by laparoscopic cholecystectomy. Decompression after supra-duodenal choledochotomy is common practice as it reduced the risk of bile leaks. We conducted a prospective non-randomized study to compare outcomes and length of stay in patients undergoing biliary stent insertion versus T-tube drainage following LCBDE via choledochotomy. The study involved 116 patients with choledocholithiasis who underwent LCBDE and decompression of the biliary system by either ante-grade biliary stent or T-tube insertion. A 7 French straight/duodenal curve biliary Diagmed™ stent (9-11 cm) was placed in 82 patients (Biliary Stent Group). T-tube insertion was used for 34 patients (T-tube group). The length of hospital stay and complications for the selected patients were recorded. All trans-cystic common bile duct explorations were excluded from the study. The mean hospital stay for patients who underwent ante-grade biliary stent or T-tube insertion after LBCDE were 1 and 3.4 days, respectively. This is a statistically significant result with a p value of less than 0.001. Of the T-tube group, two patients required laparoscopic washout due to bile leaks, one had ongoing biliary stasis and one reported ongoing pain whilst the T-tube was in situ. A complication rate of 11.2%, this was a significant finding. There were no complications or concerns reported for the Biliary Stent Group. Our results show that there is a significant reduction in length of hospital stay and morbidity for patients that have ante-grade biliary stent decompression of the CBD post laparoscopic choledochotomy when compared T-tube drainage. This implies that ante-grade biliary stent insertion is likely to reduce costs and increase overall patient satisfaction. We support the use of ante-grade biliary stent insertion during LCBDE when primary closure is not preferred.

2010 drug packaging review: identifying problems to prevent errors.

PubMed

2011-06-01

Prescrire's analyses showed that the quality of drug packaging in 2010 still left much to be desired. Potentially dangerous packaging remains a significant problem: unclear labelling is source of medication errors; dosing devices for some psychotropic drugs create a risk of overdose; child-proof caps are often lacking; and too many patient information leaflets are misleading or difficult to understand. Everything that is needed for safe drug packaging is available; it is now up to regulatory agencies and drug companies to act responsibly. In the meantime, health professionals can help their patients by learning to identify the pitfalls of drug packaging and providing safe information to help prevent medication errors.

Doppler color flow analysis of the uterine arteries before and after intrauterine device insertion: a prospective study.

PubMed

de Souza, Marco Aurélio Martins; Geber, Selmo

2006-02-01

An intrauterine device (IUD) is one of the most frequently used methods of birth control around the world. Although a relationship between its use and menstrual disorders has been well documented, only a few studies have tried to show whether there are any vascular modifications. The aim of our study was to evaluate the influence of an IUD on uterine artery blood flow using Doppler assessment. A total of 100 patients selected for IUD use were prospectively evaluated with Doppler analysis before and 30 days after insertion. The resistive index (RI) and pulsatility index (PI) were used to evaluate uterine artery vascular resistance. Patients were allocated in 2 groups according to whether they were (group 2) or were not (group 1) lactating. The PI and RI of the patients in groups 1 and 2 before and after IUD insertion were not statistically significantly different (P = .298 and .23). When we compared uterine artery blood flow indices before and after IUD insertion for groups 1 and 2 separately, we observed in group 1 that the mean +/- SD PI values were 2.45 +/- 0.62 and 2.55 +/- 0.55 (P = .38) and the RI values were 0.87 +/- 0.08 and 0.87 +/- 0.06 (P = .88) before and after IUD insertion, respectively. In group 2, the PI values were 2.31 +/- 0.55 and 2.37 +/- 0.69 (P = .68) and the RI values were 0.85 +/- 0.07 and 0.86 +/- 0.07 (P = .44) before and after IUD insertion. Finally, we used the mean blood flow indices of the uterine arteries of all patients to compare the effect of IUD insertion. Results were also not statistically significant when we compared PI and RI before and after IUD insertion. The presence of an IUD does not interfere with the vascular resistance of the uterine arteries that can be shown by Doppler flow assessments 1 month after insertion.

Teriparatide increases the insertional torque of pedicle screws during fusion surgery in patients with postmenopausal osteoporosis.

PubMed

Inoue, Gen; Ueno, Masaki; Nakazawa, Toshiyuki; Imura, Takayuki; Saito, Wataru; Uchida, Kentaro; Ohtori, Seiji; Toyone, Tomoaki; Takahira, Naonobu; Takaso, Masashi

2014-09-01

The object of this study was to examine the efficacy of preoperative teriparatide treatment for increasing the insertional torque of pedicle screws during fusion surgery in postmenopausal women with osteoporosis. Fusion surgery for the thoracic and/or lumbar spine was performed in 29 postmenopausal women with osteoporosis aged 65-82 years (mean 72.2 years). The patients were divided into 2 groups based on whether they were treated with teriparatide (n = 13) or not (n = 16) before the surgery. In the teriparatide-treated group, patients received preoperative teriparatide therapy as either a daily (20 μg/day, n = 7) or a weekly (56.5 μg/week, n = 6) injection for a mean of 61.4 days and a minimum of 31 days. During surgery, the insertional torque was measured in 212 screws inserted from T-7 to L-5 and compared between the 2 groups. The correlation between the insertional torque and the duration of preoperative teriparatide treatment was also investigated. The mean insertional torque value in the teriparatide group was 1.28 ± 0.42 Nm, which was significantly higher than in the control group (1.08 ± 0.52 Nm, p < 0.01). There was no significant difference between the daily and the weekly teriparatide groups with respect to mean insertional torque value (1.34 ± 0.50 Nm and 1.18 ± 0.43 Nm, respectively, p = 0.07). There was negligible correlation between insertional torque and duration of preoperative teriparatide treatment (r(2) = 0.05, p < 0.01). Teriparatide injections beginning at least 1 month prior to surgery were effective in increasing the insertional torque of pedicle screws during surgery in patients with postmenopausal osteoporosis. Preoperative teriparatide treatment might be an option for maximizing the purchase of the pedicle screws to the bone at the time of fusion surgery.

Implant Evaluation of an Insertable Cardiac Monitor Outside the Electrophysiology Lab Setting

PubMed Central

Pachulski, Roman; Cockrell, James; Solomon, Hemant; Yang, Fang; Rogers, John

2013-01-01

Background To date, insertable cardiac monitors (ICM) have been implanted in the hospital without critical evaluation of other potential settings. Providing alternatives to in-hospital insertion may increase access to ICM, decrease waiting times for patients awaiting diagnosis, and reduce hospital resources. Methods This was a prospective, non-randomized, clinical trial involving nine clinical sites throughout the United States designed to assess the feasibility of ICM implants in a non-hospital setting. Other than the Reveal® ICM, implant supplies and techniques were left to physician discretion in patients who met indications. Patients were followed up to 90 days post-implant. The primary objective was to characterize the number of procedure-related adverse events that required surgical intervention within 90 days. Results Sixty-five patients were implanted at nine out-of-hospital sites. The insertion procedure was well tolerated by all patients. There were no deaths, systemic infections or endocarditis. There were two (3%) procedure-related adverse events requiring device explant and four (6%) adverse events not requiring explant. ICM use led to 16 diagnoses (24.6%) with 9 patients proceeding to alternate cardiac device implants during the course of the 90-day follow up. Conclusion Out-of-hospital ICM insertion can be accomplished with comparable procedural safety and represents a reasonable alternative to the in-hospital setting. Clinicaltrials.gov registration number: NCT01168427 PMID:23977071

Software management tools: Lessons learned from use

NASA Technical Reports Server (NTRS)

Reifer, D. J.; Valett, J.; Knight, J.; Wenneson, G.

1985-01-01

Experience in inserting software project planning tools into more than 100 projects producing mission critical software are discussed. The problems the software project manager faces are listed along with methods and tools available to handle them. Experience is reported with the Project Manager's Workstation (PMW) and the SoftCost-R cost estimating package. Finally, the results of a survey, which looked at what could be done in the future to overcome the problems experienced and build a set of truly useful tools, are presented.

Related factors with extravasation of non-cytostatic agents in peripheral vein catheters.

PubMed

Fernández-García, Cristina; Mata-Peón, Esther; Avanzas-Fernández, Sara

To know the independent variables related to the occurrence of extravasation in patients with peripheral vein catheters (PVC). Retrospective study carried out in 6 longitudinal cuts between July 2013 an January 2014. A total of 1,442 PVC were reviewed, of which 730 met the inclusion criteria, and were divided into 2 groups: extravasation and not extravasation, with 365 cases each. The variables of age, gender, admission unit, catheter gauge, insertion site, previous insertion into the same limb, hospital unit where the insertion took place, communication difficulties, personal health history and analyzed parenterally drug administered were considered. Risk factors to develop extravasation were: female gender, with previous insertion in the same limb, <72h PVC of insertion, communication difficulties, personal health history of neoplasia and KCl, gentamicin or beta lactam treatment. Our study allows to know the variables that are related to the emergence of extravasations in patients with non-cancer treatments (gender, medical service of admission, catheter gauge, elapsed time since the insertion, patient communication difficulties, personal health history, and intravenous treatments), as well as the factors that may be considered protective. Copyright © 2016 Elsevier España, S.L.U. All rights reserved.

Effect of therapeutic footwear on foot reulceration in patients with diabetes: a randomized controlled trial.

PubMed

Reiber, Gayle E; Smith, Douglas G; Wallace, Carolyn; Sullivan, Katrina; Hayes, Shane; Vath, Christy; Maciejewski, Matthew L; Yu, Onchee; Heagerty, Patrick J; LeMaster, Joseph

2002-05-15

Many people with diabetes experience lower-limb ulcers. Footwear has been implicated as a primary cause of foot ulcers, yet research is limited on the efficacy of shoe and insert combinations to prevent reulceration. To determine whether extra-depth and -width therapeutic shoes used with 2 types of inserts reduce reulceration in diabetic individuals with a history of foot ulcer. Randomized clinical trial of 400 diabetes patients with history of foot ulcer in 2 Washington State health care organizations who did not require custom shoes for foot deformity and were enrolled between August 1997 and December 1998 and followed up for 2 years. Data collected at regular intervals documented physical, foot, and diabetes characteristics; footwear use; foot lesions; and ulcers. Participants were randomly assigned to receive 3 pairs of therapeutic shoes and 3 pairs of customized medium-density cork inserts with a neoprene closed-cell cover (n = 121); to receive 3 pairs of therapeutic shoes and 3 pairs of prefabricated, tapered polyurethane inserts with a brushed nylon cover (n = 119); or to wear their usual footwear (controls; n = 160). Foot reulceration, compared among the 3 groups. Two-year cumulative reulceration incidence across the 3 groups was low: 15% in the cork-insert group, 14% in the prefabricated-insert group, and 17% in controls. In the intent-to-treat analysis, patients assigned to therapeutic shoes did not have a significantly lower risk of reulceration compared with controls (risk ratio [RR] for the cork-insert group, 0.88; 95% confidence interval [CI], 0.51-1.52 and RR the for prefabricated-insert group, 0.85; 95% CI, 0.48-1.48). All ulcer episodes in patients assigned to therapeutic shoes and 88% wearing nonstudy shoes occurred in patients with foot insensitivity. This study of persons without severe foot deformity does not provide evidence to support widespread dispensing of therapeutic shoes and inserts to diabetic patients with a history of foot ulcer. Study shoes and custom cork or preformed polyurethane inserts conferred no significant ulcer reduction compared with control footwear. This study suggests that careful attention to foot care by health care professionals may be more important than therapeutic footwear but does not negate the possibility that special footwear is beneficial in persons with diabetes who do not receive such close attention to foot care by their health care providers or in individuals with severe foot deformities.

Numerical investigation of heat transfer and friction factor characteristics in a circular tube fitted with V-cut twisted tape inserts.

PubMed

Salman, Sami D; Kadhum, Abdul Amir H; Takriff, Mohd S; Mohamad, Abu Bakar

2013-01-01

Numerical investigation of the heat transfer and friction factor characteristics of a circular fitted with V-cut twisted tape (VCT) insert with twist ratio (y = 2.93) and different cut depths (w = 0.5, 1, and 1.5 cm) were studied for laminar flow using CFD package (FLUENT-6.3.26). The data obtained from plain tube were verified with the literature correlation to ensure the validation of simulation results. Classical twisted tape (CTT) with different twist ratios (y = 2.93, 3.91, 4.89) were also studied for comparison. The results show that the enhancement of heat transfer rate induced by the classical and V-cut twisted tape inserts increases with the Reynolds number and decreases with twist ratio. The results also revealed that the V-cut twisted tape with twist ratio y = 2.93 and cut depth w = 0.5 cm offered higher heat transfer rate with significant increases in friction factor than other tapes. In addition the results of V-cut twist tape compared with experimental and simulated data of right-left helical tape inserts (RLT), it is found that the V-cut twist tape offered better thermal contact between the surface and the fluid which ultimately leads to a high heat transfer coefficient. Consequently, 107% of maximum heat transfer was obtained by using this configuration.

Numerical Investigation of Heat Transfer and Friction Factor Characteristics in a Circular Tube Fitted with V-Cut Twisted Tape Inserts

PubMed Central

Salman, Sami D.; Kadhum, Abdul Amir H.; Takriff, Mohd S.; Mohamad, Abu Bakar

2013-01-01

Numerical investigation of the heat transfer and friction factor characteristics of a circular fitted with V-cut twisted tape (VCT) insert with twist ratio (y = 2.93) and different cut depths (w = 0.5, 1, and 1.5 cm) were studied for laminar flow using CFD package (FLUENT-6.3.26). The data obtained from plain tube were verified with the literature correlation to ensure the validation of simulation results. Classical twisted tape (CTT) with different twist ratios (y = 2.93, 3.91, 4.89) were also studied for comparison. The results show that the enhancement of heat transfer rate induced by the classical and V-cut twisted tape inserts increases with the Reynolds number and decreases with twist ratio. The results also revealed that the V-cut twisted tape with twist ratio y = 2.93 and cut depth w = 0.5 cm offered higher heat transfer rate with significant increases in friction factor than other tapes. In addition the results of V-cut twist tape compared with experimental and simulated data of right-left helical tape inserts (RLT), it is found that the V-cut twist tape offered better thermal contact between the surface and the fluid which ultimately leads to a high heat transfer coefficient. Consequently, 107% of maximum heat transfer was obtained by using this configuration. PMID:24078795

[For the Establishment of an Informative Support Framework in Pharmacies: Informative Support System for Diabetes].

PubMed

Yamamoto, Michiko; Doi, Hirohisa; Watanabe, Kazuhiro

2016-01-01

According to the Japanese revitalization strategy endorsed by the government in June, 2013, pharmacies are expected to play an active role as the hub of health information. But this is not sufficiently organized: an infrastructure for providing neutral information which becomes the basis of such health information is not yet established for healthcare professionals, patients and consumers. As for drug information available subsequent to the marketing of pharmaceutical products, information from the pharmaceutical companies including Package Inserts and Interview-forms are often found. However, though such information from companies is important, it is necessary for healthcare professionals and patients to have access to the information evaluated by a trustworthy third party. With overseas distribution, the dissemination of drug information is provided by third parties, which are independent of regulatory agencies. For example, National Health Service (NHS) Evidence in the UK offers wide-ranging information based on evidence from a disease to pharmaceutical products, and is a widely available information source for healthcare professionals, patients and consumers. With regard to therapeutic medications, drug information and health foods in the Japanese community, it is necessary for patients and healthcare professionals that we establish neutral and common systematic information based on the research evidence. By providing information on the Internet, which enables people to access the information easily and to assess a product's usefulness objectively, we hope to eventually develop a system that ensures a patient's safety in the use of drugs.

Horner's syndrome in patients admitted to the intensive care unit that have undergone central venous catheterization: a prospective study.

PubMed

Butty, Z; Gopwani, J; Mehta, S; Margolin, E

2016-01-01

PurposeCentral venous catheterization (CVC) is estimated to be performed in millions of patients per year. Swan-Ganz catheters used for CVC are most often inserted into the internal jugular vein and during this procedure they may come into contact with the sympathetic chain. This study aims to determine the incidence of Horner's syndrome in patients admitted to intensive care unit that have undergone internal jugular CVC insertion during their admission and to determine whether ultrasonography-assisted insertion has decreased the frequency of this complication.Patients and methodsA total of 100 prospective patients admitted to the ICU were examined for the presence of anisocoria and ptosis after undergoing recent CVC. Presence of Horner's syndrome was confirmed by testing with 0.5% apraclonidine and looking for the reversal of anisocoria.ResultsFrequency of Horner's syndrome after CVC was 2% in a sample of 100 prospectively examined patients.ConclusionHorner's syndrome remains a relatively rare but definitive complication of CVC. ICU physicians should be educated about its existence and prevalence and ophthalmologists should inquire about any history of ICU admission necessitating CVC insertion in any patient presenting with Horner's syndrome.

Safety and Effectiveness of Percutaneously Inserted Peritoneal Ports Compared to Surgically Inserted Ports in a Retrospective Study of 87 Patients with Ovarian Carcinoma over a 10-Year Period

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

Woodley-Cook, Joel, E-mail: jwoodleycook@gmail.com; Tarulli, Emidio; Tan, Kong T.

PurposePlacement of peritoneal ports has become a favorable technique for direct chemotherapy infusion in treating peritoneal metastases from ovarian cancer. We aim to outline an approach to the percutaneous insertion of peritoneal ports and to characterize success and complication rates compared to surgically inserted ports.Materials and MethodsRetrospective analysis was collected from 87 patients who had peritoneal port insertion (28 inserted surgically and 59 percutaneously) for treatment of peritoneal metastases from ovarian cancer from July 2004 to July 2014. Complications were classified according to the SIR Clinical Practice Guidelines as major or minor.ResultsTechnical success rates for surgically and percutaneously inserted portsmore » were 100 and 96.7 %, respectively (p = 0.44), with the two percutaneous failures successful at a later date. There were no major complications in either group. Minor complication rates for surgically versus percutaneously inserted ports were 46.4 versus 22.0 %, respectively (p = 0.02). The infection rate for surgically inserted versus percutaneously inserted ports was 14.3 and 0 %, respectively (p = 0.002). The relative risk of developing a complication from percutaneous peritoneal port insertion without ascites was 3.4 (p = 0.04). For percutaneously inserted ports, the mean in-room procedure time was 81 ± 1.3 min and mean fluoroscopy time was 5.0 ± 4.5 min.ConclusionPercutaneously inserted peritoneal ports are a safe alternative to surgically inserted ports, demonstrating similar technical success and lower complication rates.« less

A Phase 1 Study of a Novel Bidirectional Perfusion Cannula in Patients Undergoing Femoral Cannulation for Cardiac Surgery.

PubMed

Marasco, Silvana F; Tutungi, Elli; Vallance, Shirley A; Udy, Andrew A; Negri, Justin C; Zimmet, Adam D; McGiffin, David C; Pellegrino, Vincent A; Moshinsky, Randall A

Leg ischemia is a serious complication of femoral artery cannulation. The primary aim of this study was to assess the safety and efficacy of a novel bidirectional femoral arterial cannula (Sorin Group USA, a wholly owned subsidiary of LivaNova PLC, Arvada, CO USA) that provides both antegrade and retrograde flow, in patients undergoing peripheral cannulation for cardiopulmonary bypass during cardiac surgery. Patients undergoing routine cardiac surgery requiring femoral artery cannulation for cardiopulmonary bypass were identified preoperatively. Informed written consent was obtained in all cases. Bidirectional cannula insertion used either a surgical cut-down and wire through needle approach or a percutaneous technique. Flow in the superficial femoral artery was assessed using Doppler ultrasound after commencement of cardiopulmonary bypass. Lower limb perfusion was assessed using reflectance near-infrared spectroscopy to measure regional oxygen saturations in the cannulated limb during cardiopulmonary bypass. Fifteen patients (median age = 61.3 years, range = 26-79 years, 10 males, 5 females) underwent femoral arterial cannulation using the novel bidirectional femoral cannula between August 2016 and May 2017. Fourteen cannulae were inserted directly into the femoral artery via a surgical cut-down and wire through needle technique. One bidirectional cannula was inserted using a percutaneous insertion technique. Indications included minimally invasive mitral and aortic valve surgery, thoracic aortic aneurysm repair, and redo cardiac surgery. The median duration of cardiopulmonary bypass was 129 minutes (range = 53-228 minutes). The cannula was inserted and positioned without difficulty in 14 of 15 patients. Incorrect sizing and arterial spasm prevented correct cannula positioning in one patient. Antegrade flow in the superficial femoral artery was observed on Doppler ultrasound in 12 of 12 patients in which this was performed. Continuous stable distal perfusion was demonstrated in the cannulated limb in 14 of 15 patients. No procedural complications occurred in the immediate or convalescent postoperative period. This study demonstrates that in patients undergoing femoral arterial cannulation for cardiopulmonary bypass during cardiac surgery, the use of a novel bidirectional cannula is safe and easy to insert and provides stable distal perfusion of the cannulated limb. Use of the device should largely obviate the need to insert a separate downstream perfusion cannula or use other techniques to protect against lower limb ischemia. Further research on a larger scale and in different patient populations is now warranted.

Clinical Application and Pharmacodynamic Monitoring of Apixaban in a Patient with End-Stage Renal Disease Requiring Chronic Hemodialysis.

PubMed

Kufel, Wesley D; Zayac, Adam S; Lehmann, David F; Miller, Christopher D

2016-11-01

Despite prescribing guidance, limited data exist to describe the use of apixaban in patients with end-stage renal disease (ESRD) requiring hemodialysis (HD). Current apixaban dosing recommendations for this patient population are based largely on a single-dose pharmacokinetic study of eight patients. We describe the clinical application and pharmacodynamic monitoring of apixaban in a 62-year-old 156-kg African-American woman with nonvalvular atrial fibrillation and ESRD requiring hemodialysis who developed calciphylaxis while receiving warfarin therapy. Based on a multidisciplinary clinical judgment decision due to concern for drug accumulation after multiple doses in patients with ESRD receiving HD, she was anticoagulated with apixaban 2.5 mg twice/day, as opposed to 5 mg twice/day as recommended by the package insert. Antifactor Xa monitoring was used, and resultant peak and trough apixaban concentrations were above the upper limit of detection for our clinical laboratory (more than 2.00 IU/ml). On day 7 of her hospitalization, the patient developed gastrointestinal bleeding, and apixaban was discontinued; no further clinical signs of bleeding occurred during her subsequent hospitalization course. Use of the Naranjo Adverse Drug Reaction Probability Scale indicated a probable relationship (score of 6) between apixaban exposure and the manifestation of gastrointestinal bleeding. The patient ultimately died 44 days after the acute bleeding event; however, coagulation concerns were not implicated in the patient's death. To our knowledge, this is the first case report that describes apixaban use and associated antifactor Xa monitoring in a patient with ESRD receiving HD, and it provides concern for current apixaban dosing recommendations in this patient population. Further pharmacokinetic and clinical data are likely necessary to better characterize apixaban use in these patients to optimize safety and efficacy. © 2016 Pharmacotherapy Publications, Inc.

Predictors for cecal insertion time: the impact of abdominal visceral fat measured by computed tomography.

PubMed

Nagata, Naoyoshi; Sakamoto, Kayo; Arai, Tomohiro; Niikura, Ryota; Shimbo, Takuro; Shinozaki, Masafumi; Noda, Mitsuhiko; Uemura, Naomi

2014-10-01

Several factors affect the risk for longer cecal insertion time. The aim of this study was to identify the predictors of longer insertion time and to evaluate the effect of visceral fat measured by CT. This is a retrospective observational study. Outpatients for colorectal cancer screening who underwent colonoscopies and CT were enrolled. Computed tomography was performed in individuals who requested cancer screening and in those with GI bleeding. Information on obesity indices (BMI, visceral adipose tissue, and subcutaneous adipose tissue area), constipation score, history of abdominal surgery, poor preparation, fellow involvement, diverticulosis, patient discomfort, and the amount of sedation used was collected. The cecal insertion rate was 95.2% (899/944), and 899 patients were analyzed. Multiple regression analysis showed that female sex, lower BMI, lower visceral adipose tissue area, lower subcutaneous adipose tissue area, higher constipation score, history of surgery, poor bowel preparation, and fellow involvement were independently associated with longer insertion time. When obesity indices were considered simultaneously, smaller subcutaneous adipose tissue area (p = 0.038), but not lower BMI (p = 0.802) or smaller visceral adipose tissue area (p = 0.856), was associated with longer insertion time; the other aforementioned factors remained associated with longer insertion time. In the subanalysis of normal-weight patients (BMI <25 kg/m), a smaller subcutaneous adipose tissue area (p = 0.002), but not a lower BMI (p = 0.782), was independently associated with a longer insertion time. Longer insertion time had a positive correlation with a higher patient discomfort score (ρ = 0.51, p < 0.001) and a greater amount of midazolam use (ρ = 0.32, p < 0.001). This single-center retrospective study includes a potential selection bias. In addition to BMI and intra-abdominal fat, female sex, constipation, history of abdominal surgery, poor preparation, and fellow involvement were predictors of longer cecal insertion time. Among the obesity indices, high subcutaneous fat accumulation was the best predictive factor for easier passage of the colonoscope, even when body weight was normal.

Jet Injection of 1% buffered lidocaine versus topical ELA-Max for anesthesia before peripheral intravenous catheterization in children: a randomized controlled trial.

PubMed

Spanos, Stephanie; Booth, Rebekah; Koenig, Heidi; Sikes, Kendra; Gracely, Edward; Kim, In K

2008-08-01

Peripheral intravenous (PIV) catheter insertion is a frequent, painful procedure that is often performed with little or no anesthesia. Current approaches that minimize pain for PIV catheter insertion have several limitations: significant delay for onset of anesthesia, inadequate anesthesia, infectious disease exposure risk from needlestick injuries, and patients' needle phobia. Comparison of the anesthetic effectiveness of J-Tip needle-free jet injection of 1% buffered lidocaine to the anesthetic effectiveness of topical 4% ELA-Max for PIV catheter insertion. A prospective, block-randomized, controlled trial comparing J-Tip jet injection of 1% buffered lidocaine to a 30-minute application of 4% ELA-Max for topical anesthesia in children 8 to 15 years old presenting to a tertiary care pediatric emergency department for PIV catheter insertion. All subjects recorded self-reported visual analog scale (VAS) scores for pain at time of enrollment and pain felt following PIV catheter insertion. Jet injection subjects also recorded pain of jet injection. Subjects were videotaped during jet injection and PIV catheter insertion. Videotapes were reviewed by a single blinded reviewer for observer-reported VAS pain scores for jet injection and PIV catheter insertion. Of the 70 children enrolled, 35 were randomized to the J-Tip jet injection group and 35 to the ELA-Max group. Patient-recorded enrollment VAS scores for pain were similar between groups (P = 0.74). Patient-recorded VAS scores were significantly different between groups immediately after PIV catheter insertion (17.3 for J-Tip jet injection vs 44.6 for ELA-Max, P < 0.001). Blinded reviewer assessed VAS scores for pain after PIV catheter insertion demonstrated a similar trend, but the comparison was not statistically significant (21.7 for J-Tip jet injection vs 31.9 ELA-Max, P = 0.23). J-Tip jet injection of 1% buffered lidocaine provided greater anesthesia than a 30-minute application of ELA-Max according to patient self-assessment of pain for children aged 8 to 15 years undergoing PIV catheter insertion.

Avelumab: A Review of Its Application in Metastatic Merkel Cell Carcinoma.

PubMed

Joseph, Jocelyn; Zobniw, Chrystia; Davis, Jennifer; Anderson, Jaime; Trinh, Van Anh

2018-04-01

To summarize the clinical development of avelumab and its clinical relevance in metastatic Merkel cell carcinoma (MCC). An English-language literature search using PubMed was performed using the terms avelumab, anti-PD-1, anti-PD-L1, and MCC from January of 1950 to March 2018. Data were also obtained from package inserts, meeting abstracts, and clinical registries. All relevant published articles of avelumab were reviewed. Clinical trial registries and meeting abstracts were used for information about ongoing trials. Avelumab is a fully human monoclonal antibody that inhibits programmed death ligand-1, which reverses T-cell exhaustion and induces antitumor responses. Avelumab is safe and effective in previously treated metastatic MCC based on a phase II trial of previously treated patients with objective response rates in 28 of 88 patients, including 10 complete responses and 19 partial responses. Median overall survival (OS) was 12.9 months, and 1-year progression-free survival and OS were 30% and 52%, respectively. Grade 3 treatment-related side effects included lymphopenia (2 patients), serum creatine phosphokinase increase (1 patient), aminotransferase elevation (1 patient), and serum cholesterol increase (1 patient). Relevance to Patient Care and Clinical Practice: This review outlines the pharmacology and clinical trial data for avelumab in metastatic MCC and guides clinicians on avelumab's place in therapy. Avelumab is the first Food and Drug Administration-approved medication for metastatic MCC and provides an advantage of durable responses and possibly improved tolerability compared with traditional platinum-based chemotherapy. Clinical trials are under way to expand its utility into the adjuvant and frontline settings.

Mass Spec Studio for Integrative Structural Biology

PubMed Central

Rey, Martial; Sarpe, Vladimir; Burns, Kyle; Buse, Joshua; Baker, Charles A.H.; van Dijk, Marc; Wordeman, Linda; Bonvin, Alexandre M.J.J.; Schriemer, David C.

2015-01-01

SUMMARY The integration of biophysical data from multiple sources is critical for developing accurate structural models of large multiprotein systems and their regulators. Mass spectrometry (MS) can be used to measure the insertion location for a wide range of topographically sensitive chemical probes, and such insertion data provide a rich, but disparate set of modeling restraints. We have developed a software platform that integrates the analysis of label-based MS data with protein modeling activities (Mass Spec Studio). Analysis packages can mine any labeling data from any mass spectrometer in a proteomics-grade manner, and link labeling methods with data-directed protein interaction modeling using HADDOCK. Support is provided for hydrogen/ deuterium exchange (HX) and covalent labeling chemistries, including novel acquisition strategies such as targeted HX-tandem MS (MS2) and data-independent HX-MS2. The latter permits the modeling of highly complex systems, which we demonstrate by the analysis of microtubule interactions. PMID:25242457

BACCardI--a tool for the validation of genomic assemblies, assisting genome finishing and intergenome comparison.

PubMed

Bartels, Daniela; Kespohl, Sebastian; Albaum, Stefan; Drüke, Tanja; Goesmann, Alexander; Herold, Julia; Kaiser, Olaf; Pühler, Alfred; Pfeiffer, Friedhelm; Raddatz, Günter; Stoye, Jens; Meyer, Folker; Schuster, Stephan C

2005-04-01

We provide the graphical tool BACCardI for the construction of virtual clone maps from standard assembler output files or BLAST based sequence comparisons. This new tool has been applied to numerous genome projects to solve various problems including (a) validation of whole genome shotgun assemblies, (b) support for contig ordering in the finishing phase of a genome project, and (c) intergenome comparison between related strains when only one of the strains has been sequenced and a large insert library is available for the other. The BACCardI software can seamlessly interact with various sequence assembly packages. Genomic assemblies generated from sequence information need to be validated by independent methods such as physical maps. The time-consuming task of building physical maps can be circumvented by virtual clone maps derived from read pair information of large insert libraries.

A new FPGA architecture suitable for DSP applications

NASA Astrophysics Data System (ADS)

Liyun, Wang; Jinmei, Lai; Jiarong, Tong; Pushan, Tang; Xing, Chen; Xueyan, Duan; Liguang, Chen; Jian, Wang; Yuan, Wang

2011-05-01

A new FPGA architecture suitable for digital signal processing applications is presented. DSP modules can be inserted into FPGA conveniently with the proposed architecture, which is much faster when used in the field of digital signal processing compared with traditional FPGAs. An advanced 2-level MUX (multiplexer) is also proposed. With the added SLEEP MODE PASS to traditional 2-level MUX, static leakage is reduced. Furthermore, buffers are inserted at early returns of long lines. With this kind of buffer, the delay of the long line is improved by 9.8% while the area increases by 4.37%. The layout of this architecture has been taped out in standard 0.13 μm CMOS technology successfully. The die size is 6.3 × 4.5 mm2 with the QFP208 package. Test results show that performances of presented classical DSP cases are improved by 28.6%-302% compared with traditional FPGAs.

Total internal reflection-evanescent coupler for fiber-to-waveguide integration of planar optoelectric devices.

PubMed

Lu, Zhaolin; Prather, Dennis W

2004-08-01

We present a method for parallel coupling from a single-mode fiber, or fiber ribbon, into a silicon-on-insulator waveguide for integration with silicon optoelectronic circuits. The coupler incorporates the advantages of the vertically tapered waveguides and prism couplers, yet offers the flexibility of planar integration. The coupler can be fabricated by use of either wafer polishing technology or gray-scale photolithography. When optimal coupling is achieved in our experimental setup, the coupler can be packaged by epoxy bonding to form a fiber-waveguide parallel coupler or connector. Two-dimensional electromagnetic calculation predicts a coupling efficiency of 77% (- 1.14-dB insertion loss) for a silicon-to-silicon coupler with a uniform tunnel layer. The coupling efficiency is experimentally achieved to be 46% (-3.4-dB insertion loss), excluding the loss in silicon and the reflections from the input surface and the output facet.

Drugs dispensed at the Division of Neonatology at University Hospital in Río Cuarto, Córdoba, Argentina.

PubMed

Fungo, Marta Stella Maris; Vega, Elena María

2013-04-01

The objective was to analyze the number of drugs dispensed by the Pharmacy Department to the Neonatology Division, to find out if the use of these drugs is described on the package insert approved by the Administración Nacional de Medicamentos, Alimentos y Tecnología, ANMAT (Drug, Food and Technology Administration of Argentina) and to compare such information with that provided by Medical Associations and Commissions. Analytical, observational and retrospective study in which drugs were analyzed based on dosage units, costs and relevance in the 2011 annual budget. We analyzed the information found in ANMAT-approved label inserts, in the Neonatal Pharmacopeia of the Sociedad Argentina de Pediatría and in the Formularies of the Confederación Médica Argentina and the Comisión Nacional del Medicamento (National Medication Commission). A total of 102 drugs (91 drug substances) were dispensed throughout 2011. Drugs most commonly supplied were: antiinfective agents for systemic use (24.51%), agents for the blood and blood forming organs, cardiovascular system, and nervous system (12.72% each). The total expenditure was ARS 263,285.52. Only 21 drugs accounted for 90.73% of the cost. Out of the 14 drugs in this group, only 1 had information related to its use in neonatology in all its labels (package inserts), only 4 in some of their product information and there was no information at all in any of the remaining 9 drugs. The Neonatal Pharmacopeia reported on 12 of the 14 drugs, while the Formularies made a reference to 9 of the 14 drugs. The most widely used drugs were antiinfectives for systemic use. A total of 21 drugs accounted for 90.73% of the annual cost in drugs. Out of 14, only 1 had information of its use in neonatology in all its labels and 9 corresponded to off-label use.

System for Packaging Planetary Samples for Return to Earth

NASA Technical Reports Server (NTRS)

Badescu, Mircea; Bar-Cohen, Yoseph; Backes, paul G.; Sherrit, Stewart; Bao, Xiaoqi; Scott, James S.

2010-01-01

A system is proposed for packaging material samples on a remote planet (especially Mars) in sealed sample tubes in preparation for later return to Earth. The sample tubes (Figure 1) would comprise (1) tubes initially having open tops and closed bottoms; (2) small, bellows-like collapsible bodies inside the tubes at their bottoms; and (3) plugs to be eventually used to close the tops of the tubes. The top inner surface of each tube would be coated with solder. The side of each plug, which would fit snugly into a tube, would feature a solder-filled ring groove. The system would include equipment for storing, manipulating, filling, and sealing the tubes. The containerization system (see Figure 2) will be organized in stations and will include: the storage station, the loading station, and the heating station. These stations can be structured in circular or linear pattern to minimize the manipulator complexity, allowing for compact design and mass efficiency. The manipulation of the sample tube between stations is done by a simple manipulator arm. The storage station contains the unloaded sample tubes and the plugs before sealing as well as the sealed sample tubes with samples after loading and sealing. The chambers at the storage station also allow for plug insertion into the sample tube. At the loading station the sample is poured or inserted into the sample tube and then the tube is topped off. At the heating station the plug is heated so the solder ring melts and seals the plug to the sample tube. The process is performed as follows: Each tube is filled or slightly overfilled with sample material and the excess sample material is wiped off the top. Then, the plug is inserted into the top section of the tube packing the sample material against the collapsible bellowslike body allowing the accommodation of the sample volume. The plug and the top of the tube are heated momentarily to melt the solder in order to seal the tube.

Technique adaptation, strategic replanning, and team learning during implementation of MR-guided brachytherapy for cervical cancer.

PubMed

Skliarenko, Julia; Carlone, Marco; Tanderup, Kari; Han, Kathy; Beiki-Ardakani, Akbar; Borg, Jette; Chan, Kitty; Croke, Jennifer; Rink, Alexandra; Simeonov, Anna; Ujaimi, Reem; Xie, Jason; Fyles, Anthony; Milosevic, Michael

MR-guided brachytherapy (MRgBT) with interstitial needles is associated with improved outcomes in cervical cancer patients. However, there are implementation barriers, including magnetic resonance (MR) access, practitioner familiarity/comfort, and efficiency. This study explores a graded MRgBT implementation strategy that included the adaptive use of needles, strategic use of MR imaging/planning, and team learning. Twenty patients with cervical cancer were treated with high-dose-rate MRgBT (28 Gy in four fractions, two insertions, daily MR imaging/planning). A tandem/ring applicator alone was used for the first insertion in most patients. Needles were added for the second insertion based on evaluation of the initial dosimetry. An interdisciplinary expert team reviewed and discussed the MR images and treatment plans. Dosimetry-trigger technique adaptation with the addition of needles for the second insertion improved target coverage in all patients with suboptimal dosimetry initially without compromising organ-at-risk (OAR) sparing. Target and OAR planning objectives were achieved in most patients. There were small or no systematic differences in tumor or OAR dosimetry between imaging/planning once per insertion vs. daily and only small random variations. Peer review and discussion of images, contours, and plans promoted learning and process development. Technique adaptation based on the initial dosimetry is an efficient approach to implementing MRgBT while gaining comfort with the use of needles. MR imaging and planning once per insertion is safe in most patients as long as applicator shifts, and large anatomical changes are excluded. Team learning is essential to building individual and programmatic competencies. Copyright © 2017 American Brachytherapy Society. Published by Elsevier Inc. All rights reserved.

Use of peripherally inserted central venous catheters (PICCs) in children receiving autologous or allogeneic stem-cell transplantation.

PubMed

Benvenuti, Stefano; Ceresoli, Rosanna; Boroni, Giovanni; Parolini, Filippo; Porta, Fulvio; Alberti, Daniele

2018-03-01

The aim of our study was to present our experience with the use of peripherally inserted central catheters (PICCs) in pediatric patients receiving autologous or allogenic blood stem-cell transplantation. The insertion of the device in older children does not require general anesthesia and does not require a surgical procedure. From January 2014 to January 2017, 13 PICCs were inserted as a central venous device in 11 pediatric patients submitted to 14 autologous or allogeneic stem-cell transplantation, at the Bone Marrow Transplant Unit of the Children's Hospital of Brescia. The mean age of patients at the time of the procedure was 11.3 years (range 3-18 years). PICCs remained in place for an overall period of 4104 days. All PICCs were positioned by the same specifically trained physician and utilized by nurses of our stem-cell transplant unit. No insertion-related complications were observed. Late complications were catheter ruptures and line occlusions (1.2 per 1000 PICC days). No rupture or occlusion required removal of the device. No catheter-related venous thrombosis, catheter-related bloodstream infection (CRBSI), accidental removal or permanent lumen occlusion were observed. Indications for catheter removal were completion of therapy (8 patients) and death (2 patients). Three PICCs are currently being used for blood sampling in follow-up patients after transplantation. Our data suggest that PICCs are a safe and effective alternative to conventional central venous catheters even in pediatric patients with high risk of infectious and hemorrhagic complications such as patients receiving stem-cell transplantation.

A prospective comparison of performance during back-to-back, anterograde manual spiral enteroscopy and double-balloon enteroscopy.

PubMed

Despott, Edward J; Murino, Alberto; Bourikas, Leonidas; Nakamura, Masanao; Ramachandra, Vino; Fraser, Chris

2015-05-01

Spiral enteroscopy is a recently introduced technology alternative to balloon-assisted enteroscopy for examination of the small bowel. To compare small bowel insertion depths and procedure duration by spiral enteroscopy and double-balloon enteroscopy performed in the same cohort of patients, in immediate succession, using the same method of insertion depth estimation. A prospective, back-to-back comparative study was performed in 15 patients. Spiral enteroscopy procedures were performed first and a tattoo was placed to mark the most distal point. Double-balloon enteroscopy passed the tattoo placed at spiral enteroscopy in 14/15 cases (93%). Median insertion depths for double-balloon enteroscopy and spiral enteroscopy were 265cm and 175cm, respectively (P=0.004). Median time to achieve maximal depth of insertion was significantly shorter for spiral enteroscopy compared with double-balloon enteroscopy (24min vs. 45min, respectively; P=0.0005). However, in 14 patients no differences were found in median time to reach the same insertion depth (P=0.28). Double-balloon enteroscopy achieved significantly greater small bowel insertion depth than spiral enteroscopy. Although overall double-balloon enteroscopy procedure duration was longer, the time taken to reach the same small bowel insertion depth by both spiral enteroscopy and double-balloon enteroscopy was similar. Copyright © 2015 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

Randomized clinical trial of pigtail catheter versus chest tube in injured patients with uncomplicated traumatic pneumothorax.

PubMed

Kulvatunyou, N; Erickson, L; Vijayasekaran, A; Gries, L; Joseph, B; Friese, R F; O'Keeffe, T; Tang, A L; Wynne, J L; Rhee, P

2014-01-01

Small pigtail catheters appear to work as well as the traditional large-bore chest tubes in patients with traumatic pneumothorax, but it is not known whether the smaller pigtail catheters are associated with less tube-site pain. This study was conducted to compare tube-site pain following pigtail catheter or chest tube insertion in patients with uncomplicated traumatic pneumothorax. This prospective randomized trial compared 14-Fr pigtail catheters and 28-Fr chest tubes in patients with traumatic pneumothorax presenting to a level I trauma centre from July 2010 to February 2012. Patients who required emergency tube placement, those who refused and those who could not respond to pain assessment were excluded. Primary outcomes were tube-site pain, as assessed by a numerical rating scale, and total pain medication use. Secondary outcomes included the success rate of pneumothorax resolution and insertion-related complications. Forty patients were enrolled. Baseline characteristics of 20 patients in the pigtail catheter group were similar to those of 20 patients in the chest tube group. No patient had a flail chest or haemothorax. Pain scores related to chest wall trauma were similar in the two groups. Patients with a pigtail catheter had significantly lower mean(s.d.) tube-site pain scores than those with a chest tube, at baseline after tube insertion (3.2(0.6) versus 7.7(0.6); P < 0.001), on day 1 (1.9(0.5) versus 6.2(0.7); P < 0.001) and day 2 (2.1(1.1) versus 5.5(1.0); P = 0.040). The decreased use of pain medication associated with pigtail catheter was not significantly different. The duration of tube insertion, success rate and insertion-related complications were all similar in the two groups. For patients with a simple, uncomplicated traumatic pneumothorax, use of a 14-Fr pigtail catheter is associated with reduced pain at the site of insertion, with no other clinically important differences noted compared with chest tubes. NCT01537289 (http://clinicaltrials.gov). © 2013 BJS Society Ltd. Published by John Wiley & Sons Ltd.

Lesion insertion in the projection domain: Methods and initial results

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

Chen, Baiyu; Leng, Shuai; Yu, Lifeng

2015-12-15

Purpose: To perform task-based image quality assessment in CT, it is desirable to have a large number of realistic patient images with known diagnostic truth. One effective way of achieving this objective is to create hybrid images that combine patient images with inserted lesions. Because conventional hybrid images generated in the image domain fails to reflect the impact of scan and reconstruction parameters on lesion appearance, this study explored a projection-domain approach. Methods: Lesions were segmented from patient images and forward projected to acquire lesion projections. The forward-projection geometry was designed according to a commercial CT scanner and accommodated bothmore » axial and helical modes with various focal spot movement patterns. The energy employed by the commercial CT scanner for beam hardening correction was measured and used for the forward projection. The lesion projections were inserted into patient projections decoded from commercial CT projection data. The combined projections were formatted to match those of commercial CT raw data, loaded onto a commercial CT scanner, and reconstructed to create the hybrid images. Two validations were performed. First, to validate the accuracy of the forward-projection geometry, images were reconstructed from the forward projections of a virtual ACR phantom and compared to physically acquired ACR phantom images in terms of CT number accuracy and high-contrast resolution. Second, to validate the realism of the lesion in hybrid images, liver lesions were segmented from patient images and inserted back into the same patients, each at a new location specified by a radiologist. The inserted lesions were compared to the original lesions and visually assessed for realism by two experienced radiologists in a blinded fashion. Results: For the validation of the forward-projection geometry, the images reconstructed from the forward projections of the virtual ACR phantom were consistent with the images physically acquired for the ACR phantom in terms of Hounsfield unit and high-contrast resolution. For the validation of the lesion realism, lesions of various types were successfully inserted, including well circumscribed and invasive lesions, homogeneous and heterogeneous lesions, high-contrast and low-contrast lesions, isolated and vessel-attached lesions, and small and large lesions. The two experienced radiologists who reviewed the original and inserted lesions could not identify the lesions that were inserted. The same lesion, when inserted into the projection domain and reconstructed with different parameters, demonstrated a parameter-dependent appearance. Conclusions: A framework has been developed for projection-domain insertion of lesions into commercial CT images, which can be potentially expanded to all geometries of CT scanners. Compared to conventional image-domain methods, the authors’ method reflected the impact of scan and reconstruction parameters on lesion appearance. Compared to prior projection-domain methods, the authors’ method has the potential to achieve higher anatomical complexity by employing clinical patient projections and real patient lesions.« less

Lesion insertion in the projection domain: Methods and initial results

PubMed Central

Chen, Baiyu; Leng, Shuai; Yu, Lifeng; Yu, Zhicong; Ma, Chi; McCollough, Cynthia

2015-01-01

Purpose: To perform task-based image quality assessment in CT, it is desirable to have a large number of realistic patient images with known diagnostic truth. One effective way of achieving this objective is to create hybrid images that combine patient images with inserted lesions. Because conventional hybrid images generated in the image domain fails to reflect the impact of scan and reconstruction parameters on lesion appearance, this study explored a projection-domain approach. Methods: Lesions were segmented from patient images and forward projected to acquire lesion projections. The forward-projection geometry was designed according to a commercial CT scanner and accommodated both axial and helical modes with various focal spot movement patterns. The energy employed by the commercial CT scanner for beam hardening correction was measured and used for the forward projection. The lesion projections were inserted into patient projections decoded from commercial CT projection data. The combined projections were formatted to match those of commercial CT raw data, loaded onto a commercial CT scanner, and reconstructed to create the hybrid images. Two validations were performed. First, to validate the accuracy of the forward-projection geometry, images were reconstructed from the forward projections of a virtual ACR phantom and compared to physically acquired ACR phantom images in terms of CT number accuracy and high-contrast resolution. Second, to validate the realism of the lesion in hybrid images, liver lesions were segmented from patient images and inserted back into the same patients, each at a new location specified by a radiologist. The inserted lesions were compared to the original lesions and visually assessed for realism by two experienced radiologists in a blinded fashion. Results: For the validation of the forward-projection geometry, the images reconstructed from the forward projections of the virtual ACR phantom were consistent with the images physically acquired for the ACR phantom in terms of Hounsfield unit and high-contrast resolution. For the validation of the lesion realism, lesions of various types were successfully inserted, including well circumscribed and invasive lesions, homogeneous and heterogeneous lesions, high-contrast and low-contrast lesions, isolated and vessel-attached lesions, and small and large lesions. The two experienced radiologists who reviewed the original and inserted lesions could not identify the lesions that were inserted. The same lesion, when inserted into the projection domain and reconstructed with different parameters, demonstrated a parameter-dependent appearance. Conclusions: A framework has been developed for projection-domain insertion of lesions into commercial CT images, which can be potentially expanded to all geometries of CT scanners. Compared to conventional image-domain methods, the authors’ method reflected the impact of scan and reconstruction parameters on lesion appearance. Compared to prior projection-domain methods, the authors’ method has the potential to achieve higher anatomical complexity by employing clinical patient projections and real patient lesions. PMID:26632058

Location of the levator veli palatini insertion following levator retropositioning, palatal pushback, and pharyngeal flap procedures.

PubMed

Mulliken, J B; Giargiana, F A; Claybaugh, G J; Hoopes, J E

1975-07-01

A long-term cineradiographic follow-up study of twenty patients with velo-pharyngeal incompetence fails to demonstrate predictable retrodisplacement of the levator insertion following combined levator retropositioning, pushback, and pharyngeal flap procedures. Simple levator retropositioning gave posterior displacement in the two patients evaluated. Patients with normal or posterior levator insertions pre-operatively all demonstrated post-operative anterior displacement following pharyngeal flap procedures, either alone or in combination with pushback. Anterior levator displacement may be the result of scar contraction or division of the levator sling (during insetting of a pharyngeal flap). Pre-operative and post-operative speech evaluation demonstrated substantial improvement in all except 3 patients; 2 of the poor speech results were patients with demonstrated levator retrodisplacement on post-operative cineradiography.

Progression of scoliosis in patients with spastic quadriplegia after the insertion of an intrathecal baclofen pump.

PubMed

Ginsburg, Glen M; Lauder, Anthony J

2007-11-15

Medical and radiographic review of 19 consecutive patients with spastic quadriplegia before and after intrathecal baclofen pump insertion with special attention paid to progression of scoliosis. Many orthopedic surgeons who treat spastic quadriplegic patients have noticed a trend of marked scoliosis progression after the administration of intrathecal baclofen (ITB) via subcutaneous pump and catheter. The purpose of this study is to quantify scoliosis progression in this patient population before and after baclofen administration and compare this to published natural history data. The authors had noted rapid progression of scoliosis in spastic quadriplegic patients after intrathecal baclofen pump insertion. This had been noted at other centers, but no significant statistical analysis had been done comparing prepump to postpump scoliosis progression in these patients. To document the magnitude and rate of scoliosis progressions after the placement of an ITB pump, the charts and radiographs of 19 consecutive nonambulatory patients with spastic quadriplegia and an ITB pump were reviewed. To document the rate of scoliosis progression, each patient had at least 2 pre and 2 postpump insertion spinal radiographs made. All radiographs were made with the patients in the supine position without orthoses. A board-certified orthopedic surgeon reviewed these radiographs. Skeletal maturity was assessed using Risser grading. Catheter tip location and rate of baclofen administration were recorded. For 19 patients with complete radiographic data, average Cobb angles were 10.2 degrees before pump insertion and 25 degrees at an average of 20.9 months after pump insertion (P < 0.0001). These 19 patients had a mean rate of change in their Cobb angles of 1.825%/year before pump insertion and 10.95 degrees /year at an average of 23.9 months after pump insertion (P = 0.024). These results represent a 6-fold increase in the curve progression rate after pump insertion. There was no association between catheter tip location or rate of Baclofen infusion on curve progression. In published data, the rate of progression of scoliosis in skeletally immature nonambulatory patients with cerebral palsy was 4.5 degrees /year. In this study, the average rate of progression of the scoliosis for the immature was 9.02 degrees /year. For the skeletally mature bed-ridden patients, the worst-case natural history progression was 4.4 degrees /year. The comparable rate of change in skeletally mature (Risser 5) nonambulatory patients (n = 6) in this study was 28.4 degrees /year. This study demonstrates a significant increase in the rate of scoliotic curve progression after ITB pump placement when compared with published natural history data. The evidence of the beneficial effects of ITB on spasticity has been confirmed, and as larger, prospective randomized studies are conducted, the authors think that support for continued use of this treatment will increase. However, early bracing and spinal fusion may be warranted to prevent significant increases in spinal deformity if scoliosis is anticipated to progress more than 10 degrees /yr for patients with spastic quadriplegia and ITB pump. The authors are now performing spinal fusions for curves that exceed 40 degrees to 50 degrees in the presence of an ITB pump as recommended by previous reviews of scoliosis and accompanying quadriplegia.

Definitive airway management after pre-hospital supraglottic airway insertion: Outcomes and a management algorithm for trauma patients.

PubMed

Hernandez, Matthew C; Aho, Johnathon M; Zielinski, Martin D; Zietlow, Scott P; Kim, Brian D; Morris, David S

2018-01-01

Prehospital airway management increasingly involves supraglottic airway insertion and a paucity of data evaluates outcomes in trauma populations. We aim to describe definitive airway management in traumatically injured patients who necessitated prehospital supraglottic airway insertion. We performed a single institution retrospective review of multisystem injured patients (≥15years) that received prehospital supraglottic airway insertion during 2009 to 2016. Baseline demographics, number and type of: supraglottic airway insertion attempts, definitive airway and complications were recorded. Primary outcome was need for tracheostomy. Univariate and multivariable statistics were performed. 56 patients met inclusion criteria and were reviewed, 78% were male. Median age [IQR] was 36 [24-56] years. Injuries comprised blunt (94%), penetrating (4%) and burns (2%). Median ISS was 26 [22-41]. Median number of prehospital endotracheal intubation (PETI) attempts was 2 [1-3]. Definitive airway management included: (n=20, 36%, tracheostomy), (n=10, 18%, direct laryngoscopy), (n=6, 11%, bougie), (n=9, 15%, Glidescope), (n=11, 20%, bronchoscopic assistance). 24-hour mortality was 41%. Increasing number of PETI was associated with increasing facial injury. On regression, increasing cervical and facial injury patterns as well as number of PETI were associated with definitive airway control via surgical tracheostomy. After supraglottic airway insertion, operative or non-operative approaches can be utilized to obtain a definitive airway. Patients with increased craniofacial injuries have an increased risk for airway complications and need for tracheostomy. We used these factors to generate an evidence based algorithm that requires prospective validation. Level IV - Retrospective study. Retrospective single institution study. Copyright © 2017 Elsevier Inc. All rights reserved.

Peripherally Inserted Central Venous Catheters in Pediatric Hematology/Oncology Patients in Tertiary Care Setting: A Developing Country Experience.

PubMed

Fadoo, Zehra; Nisar, Muhammad I; Iftikhar, Raza; Ali, Sajida; Mushtaq, Naureen; Sayani, Raza

2015-10-01

Peripherally inserted central venous catheters (PICC) have been successfully used to provide central access for chemotherapy and frequent transfusions. The purpose of this study was to assess the feasibility of PICCs and determine PICC-related complications in pediatric hematology/oncology patients in a resource-poor setting. All pediatric patients (age below 16 y) with hematologic and malignant disorders who underwent PICC line insertion at Aga Khan University Hospital from January 2008 to June 2010 were enrolled in the study. Demographic features, primary diagnosis, catheter days, complications, and reasons for removal of device were recorded. Total of 36 PICC lines were inserted in 32 pediatric patients. Complication rate of 5.29/1000 catheter days was recorded. Our study showed comparable complication profile such as infection rate, occlusion, breakage, and dislodgement. The median catheter life was found to be 69 days. We conclude that PICC lines are feasible in a resource-poor setting and recommend its use for chemotherapy administration and prolonged venous access.

Retrievable Vena Cava Filters in Major Trauma Patients: Prevalence of Thrombus Within the Filter

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

Mahrer, Arie; Zippel, Douglas; Garniek, Alexander

The purpose of this study was to report the prevalence of thrombus within a retrievable vena cava filter inserted prophylactically in major trauma patients referred for filter extraction. Between November 2002 and August 2005, 80 retrievable inferior vena cava filters (68 Optease and 12 Gunther-Tulip) were inserted into critically injured trauma patients (mean injury severity score 33.5). The filters were inserted within 1 to 6 (mean 2) days of injury. Thirty-seven patients were referred for filter removal (32 with Optease and 5 with Gunther-Tulip). The indwelling time was 7 to 22 (mean 13) days. All patients underwent inferior vena cavographymore » prior to filter removal. There were no insertion-related complications and all filters were successfully deployed. Forty-three (54%) of the 80 patients were not referred for filter removal, as these patients continued to have contraindications to anticoagulation. Thirty-seven patients (46%) were referred for filter removal. In eight of them (22%) a large thrombus was seen within the filters and they were left in place, all with the Optease device. The other 29 filters (36%) were removed uneventfully.We conclude that the relatively high prevalence of intrafilter thrombi with the Optease filter may be explained by either spontaneous thrombus formation or captured emboli.« less

PIMMS (Pragmatic Insertional Mutation Mapping System) Laboratory Methodology a Readily Accessible Tool for Identification of Essential Genes in Streptococcus

PubMed Central

Blanchard, Adam M.; Egan, Sharon A.; Emes, Richard D.; Warry, Andrew; Leigh, James A.

2016-01-01

The Pragmatic Insertional Mutation Mapping (PIMMS) laboratory protocol was developed alongside various bioinformatics packages (Blanchard et al., 2015) to enable detection of essential and conditionally essential genes in Streptococcus and related bacteria. This extended the methodology commonly used to locate insertional mutations in individual mutants to the analysis of mutations in populations of bacteria. In Streptococcus uberis, a pyogenic Streptococcus associated with intramammary infection and mastitis in ruminants, the mutagen pGhost9:ISS1 was shown to integrate across the entire genome. Analysis of >80,000 mutations revealed 196 coding sequences, which were not be mutated and a further 67 where mutation only occurred beyond the 90th percentile of the coding sequence. These sequences showed good concordance with sequences within the database of essential genes and typically matched sequences known to be associated with basic cellular functions. Due to the broad utility of this mutagen and the simplicity of the methodology it is anticipated that PIMMS will be of value to a wide range of laboratories in functional genomic analysis of a wide range of Gram positive bacteria (Streptococcus, Enterococcus, and Lactococcus) of medical, veterinary, and industrial significance. PMID:27826289

An investigation of nonuniform dose deposition from an electron beam

NASA Astrophysics Data System (ADS)

Lilley, William; Luu, Kieu X.

1994-08-01

In a search for an explanation of nonuniform electron-beam dose deposition, the integrated tiger series (ITS) of coupled electron/photon Monte Carlo transport codes was used to calculate energy deposition in the package materials of an application-specific integrated circuit (ASIC) while the thicknesses of some of the materials were varied. The thicknesses of three materials that were in the path of an electron-beam pulse were varied independently so that analysis could determine how the radiation dose measurements using thermoluminescent dosimeters (TLD's) would be affected. The three materials were chosen because they could vary during insertion of the die into the package or during the process of taking dose measurements. The materials were aluminum, HIPEC (a plastic), and silver epoxy. The calculations showed that with very small variations in thickness, the silver epoxy had a large effect on the dose uniformity over the area of the die.

Therapeutic peroral direct cholangioscopy using a single balloon enteroscope in patients with Roux-en-Y anastomosis (with videos).

PubMed

Yamauchi, Hiroshi; Kida, Mitsuhiro; Okuwaki, Kosuke; Miyazawa, Shiro; Matsumoto, Takaaki; Uehara, Kazuho; Miyata, Eiji; Hasegawa, Rikiya; Kaneko, Toru; Laopeamthong, Issaree; Lei, Yang; Iwai, Tomohisa; Imaizumi, Hiroshi; Koizumi, Wasaburo

2018-01-01

Peroral cholangioscopic lithotripsy is a useful procedure in patients with a normal gastrointestinal anatomy who have difficult-to-treat stones. We evaluated the usefulness of peroral direct cholangioscopy (PDCS) using single-balloon enteroscope (SBE) in patients with difficult-to-treat stones who had undergone Roux-en-Y reconstruction. Among 118 patients (169 sessions) who underwent SBE-assisted endoscopic retrograde cholangiopancreatography to treat biliary stones after Roux-en-Y reconstruction, patients in whom it was difficult to remove biliary stones via a transpapillary or transanastomotic approach and difficult to switch to ultra-slim endoscope, were retrospectively enrolled. The biliary insertion success rate, procedure success rate, procedure time, and procedural complications were assessed. The SBE was inserted into the bile-duct, first using a free-hand technique, second using a guide wire, and third using the large balloon anchoring and deflation (LBAD) technique. A total of 11 patients (14 sessions) were enrolled in this study. The biliary insertion success rate was 100%. Bile-duct insertion was performed using a free-hand technique in 4 sessions, a guide wire in 3 sessions (rendezvous technique, 2 sessions), and the LBAD technique in 7 sessions. The procedure success rate was 86% in first session, and 100% in second session. The median procedure time was 81 min (range 49-137). The median procedure time in the bile-duct was 21.5 min (range 6-60). Mild pancreatitis occurred as a complication in one patient. The median follow-up was 528 days (range 282-764). No patient had stone recurrence. PDCS using SBE is a useful procedure in patients with Roux-en-Y reconstruction. The LBAD technique is an useful technique of inserting SBE into the bile-duct.

Obstructive Left Colon Cancer Should Be Managed by Using a Subtotal Colectomy Instead of Colonic Stenting

PubMed Central

Min, Chung Ki; Lee, Donghyoun; Jung, Kyung Uk; Lee, Sung Ryol; Kim, Hungdai; Chun, Ho-Kyung

2016-01-01

Purpose This study compared a subtotal colectomy to self-expandable metallic stent (SEMS) insertion as a bridge to surgery for patients with left colon-cancer obstruction. Methods Ninety-four consecutive patients with left colon-cancer obstruction underwent an emergency subtotal colectomy or elective SEMS insertion between January 2007 and August 2014. Using prospectively collected data, we performed a retrospective comparative analysis on an intention-to-treat basis. Results A subtotal colectomy and SEMS insertion were attempted in 24 and 70 patients, respectively. SEMS insertion technically failed in 5 patients (7.1%). The mean age and rate of obstruction in the descending colon were higher in the subtotal colectomy group than the SEMS group. Sex, underlying disease, American Society of Anesthesiologists physical status, and pathological stage showed no statistical difference. Laparoscopic surgery was performed more frequently in patients in the SEMS group (62 of 70, 88.6%) than in patients in the subtotal colectomy group (4 of 24, 16.7%). The overall rate of postoperative morbidity was higher in the SEMS group. No Clavien-Dindo grade III or IV complications occurred in the subtotal colectomy group, but 2 patients (2.9%) died from septic complications in the SEMS group. One patient (4.2%) in the subtotal colectomy group had synchronous cancer. The total hospital stay was shorter in the subtotal colectomy group. The median number of bowel movements in the subtotal colectomy group was twice per day at postoperative 3–6 months. Conclusion A subtotal colectomy for patients with obstructive left-colon cancer is a clinically and oncologically safer, 1-stage, surgical strategy compared to SEMS insertion as a bridge to surgery. PMID:28119864

Association of Time between Surgery and Adjuvant Therapy with Survival in Oral Cavity Cancer.

PubMed

Chen, Michelle M; Harris, Jeremy P; Orosco, Ryan K; Sirjani, Davud; Hara, Wendy; Divi, Vasu

2018-06-01

Objective The National Cancer Center Network recommends starting radiation therapy within 6 weeks after surgery for oral cavity squamous cell carcinoma (OCSCC), but there is limited evidence of the importance of the total time from surgery to completion of radiation therapy (package time). We set out to determine if there was an association between package time and survival in OCSCC and to evaluate the impact of treatment location on outcomes. Study Design Retrospective cohort study. Setting Tertiary academic medical center. Subjects and Methods We reviewed the records of patients with OCSCC who completed postoperative radiation therapy at an academic medical center from 2008 to 2016. The primary endpoints were overall survival and recurrence-free survival. Statistical analysis included χ 2 tests and Cox proportional hazards regressions. Results We identified 132 patients with an average package time of 12.6 weeks. On multivariate analysis, package time >11 weeks was independently associated with decreased overall survival (hazard ratio, 6.68; 95% CI, 1.42-31.44) and recurrence-free survival (hazard ratio, 2.94; 95% CI, 1.20-7.18). Patients who received radiation therapy at outside facilities were more likely to have treatment delays (90.2% vs 62.9%, P = .001). Conclusions Prolonged package times are associated with decreased overall and recurrence-free survival among patients with OCSCC. Patients who received radiation therapy at outside facilities are more likely to have prolonged package times.

SU-E-T-64: A Programmable Moving Insert for the ArcCHECK Phantom for Dose Verification of Respiratory-Gated VMAT

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

Gaede, S; Jordan, K; Western University, London, ON

Purpose: To present a customized programmable moving insert for the ArcCHECK™ phantom that can, in a single delivery, check both entrance dosimetry, while simultaneously verifying the delivery of respiratory-gated VMAT. Methods: The cylindrical motion phantom uses a computer-controlled stepping motor to move an insert inside a stationery sleeve. Insert motion is programmable and can include rotational motion in addition to linear motion along the axis of the cylinder. The sleeve fits securely in the bore of the ArcCHECK™. Interchangeable inserts, including an A1SL chamber, optically-stimulated luminescence dosimeters, radiochromic film, or 3D gels, allow this combination to be used for commissioning,more » routine quality assurance, and patient-specific dosimetric verification of respiratory-gated VMAT. Before clinical implementation, the effect of a moving insert on the ArcCHECK™ measurements was considered. First, the measured dose to the ArcCHECK™ containing multiple inserts in the static position was compared to the calculated dose during multiple VMAT treatment deliveries. Then, dose was measured under both sinusoidal and real-patient motion conditions to determine any effect of the moving inserts on the ArcCHECK™ measurements. Finally, dose was measured during gated VMAT delivery to the same inserts under the same motion conditions to examine any effect of various beam “on-and-off” and dose rate ramp “up-and-down”. Multiple comparisons between measured and calculated dose to different inserts were also considered. Results: The pass rate for the static delivery exceeded 98% for all measurements (3%/3mm), suggesting a valid setup for entrance dosimetry. The pass rate was not altered for any measurement delivered under motion conditions. A similar Result was observed under gated VMAT conditions, including agreement of measured and calculated dose to the various inserts. Conclusion: Incorporating a programmable moving insert within the ArcCHECK™ phantom provides an efficient verification of respiratory-gated VMAT delivery that is useful during commissioning, routine quality assurance, and patient-specific dose verification. Prototype phantom development and testing was performed in collaboration with Modus Medical Devices Inc. (London, ON). No financial support was granted.« less

An approach to tracheostomy in a patient with an expandable metallic tracheal stent.

PubMed

Madden, Brendan P; Sheth, Abhijat

2005-09-01

With increasing use of expandable metallic stents to manage patients with a variety of endobronchial pathologies, some will have a subsequent need for tracheostomy insertion. We describe a successful technique to insert a tracheostomy using rigid and fibre-optic bronchoscopy in a patient who had an 8 cm expandable metallic tracheal stent deployed previously on account of tracheomalacia.

Suprapatellar Versus Infrapatellar Tibial Nail Insertion: A Prospective Randomized Control Pilot Study.

PubMed

Chan, Daniel S; Serrano-Riera, Rafael; Griffing, Rebecca; Steverson, Barbara; Infante, Anthony; Watson, David; Sagi, H Claude; Sanders, Roy W

2016-03-01

The purpose of this OTA-approved pilot study was to compare the clinical and functional outcomes of the knee joint after infrapatellar (IP) versus suprapatellar (SP) tibial nail insertion. Prospective, randomized. Level I trauma center. After institutional review board approval, skeletally mature patients with OTA 42 tibial shaft fractures were randomized into either an IP or SP nail insertion group after informed consent was obtained. The SP also underwent prenail and postnail insertion patella-femoral (PF) joint arthroscopy. Patients underwent follow-up (6 weeks, 3, 6, and 12 months) with standard radiographs, as well as visual analog score and pain diagram documentation. At the 6-month and 12-month visits, knee function questionnaires (Lysholm knee scale and SF-36) were completed. Magnetic resonance imaging/image (MRI) of the affected knee was obtained at 12 months. Ten patients in each group were required for a power analysis for the anticipated larger randomized control trial, but enrollment in each arm was not limited because of known problems with patient follow-up over a 12-month period. A total of 41 patients/fractures were enrolled in this study. Of those, only 25 patients/fractures (14 IP, 11 SP) fully complied with and completed 12 months of follow-up. Six of 11 SP presented with articular changes (chondromalacia) in the PF joint during the preinsertion arthroscopy. Three patients displayed a change in the articular cartilage based on postnail insertion arthroscopy. At 12 months, all fractures in both groups had proceeded to union. There were no differences between the affected and unaffected knee with respect to range of motion. Functional visual analog score and Lysholm knee scores showed no significant differences between groups (P > 0.05). The SF-36v2 comparison also revealed no significant differences in the overall score, all 4 mental components, and 3/4 physical components (P > 0.05). The bodily pain component score was superior in the SP group (45 vs. 36, P = 0.035). All 11 SP patients obtained MRIs at 1 year. Five of these patients had evidence of chondromalacia on MRI. These findings did not correlate with either the prenail or postnail insertion arthroscopy. Importantly, no patient in the SP group with postnail insertion arthroscopic changes had PF joint pain at 1 year. Overall, there seemed to be no significant differences in pain, disability, or knee range of motion between these 2 tibial intramedullary nail insertion techniques after 12 months of follow-up. Based on this pilot study data, larger prospective trial with long-term follow-up is warranted. Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

Treatment of Insertional Achilles Pathology With Dorsal Wedge Calcaneal Osteotomy in Athletes.

PubMed

Georgiannos, Dimitrios; Lampridis, Vasilis; Vasiliadis, Angelos; Bisbinas, Ilias

2017-04-01

Insertional Achilles tendinopathy and retrocalcaneal bursitis is difficult to treat, and several operative techniques have been used after failure of conservative management. Dorsal wedge calcaneal osteotomy has been described for the treatment of insertional Achilles pathology. It was hypothesized that dorsal wedge calcaneal osteotomy would be an effective and safe method for the treatment of athletes with insertional Achilles pathology unrelieved by nonoperative measures. Fifty-two athletes (64 feet) who had painful Achilles tendon syndrome unrelieved by 6 months of nonoperative measures were treated surgically. Dorsally based wedge calcaneal osteotomy was performed through a lateral approach, and 2 staples were used for fixation. Patients were scored pre- and postoperatively with the American Orthopaedic Foot & Ankle Society (AOFAS) ankle-hindfoot and Victorian Institute of Sports of Australia-Achilles (VISA-A) scores. At a minimum follow-up of 3 years, the patients' AOFAS and VISA-A scores improved from 59.5 ± 15.0 and 65.9 ± 11.1 preoperatively to 95.7 ± 6.2 and 90.2 ± 8.4 postoperatively, respectively. Clinical results were considered excellent in 38 patients, good in 12 patients, and fair in 2 patients. Return to previous sports activity time was 21 (SD, 8.0) weeks. One patient necessitated a revision operation. Operative treatment of insertional Achilles pathology in athletes with dorsal closing wedge calcaneal osteotomy was a safe and effective method that allowed for a quicker return to previous level of sports activities compared with other techniques. Level IV, retrospective case series.

Role of the 2 adenine (g.11293_11294insAA) insertion polymorphism in the 3' untranslated region of the factor VII (FVII) gene: molecular characterization of a patient with severe FVII deficiency.

PubMed

Peyvandi, F; Garagiola, I; Palla, R; Marziliano, N; Mannucci, P M

2005-11-01

Polymorphic variants in the gene encoding factor VII (F7) affect the plasma levels of this coagulation protein and modify the clinical phenotype of FVII deficiency in some patients. In this study we report the in vitro functional analysis of a novel polymorphic variant located in the 3' untranslated region of F7: g.11293_11294insAA. To determine whether this variant regulates FVII expression, we initially compared an expression vector containing FVII cDNA with g.11293_11294insAA with the FVII wild-type (WT) construct. The kinetics of mRNA production showed that the insertion decreases the steady-state FVII mRNA levels. To assess whether the insertion influences the phenotype of FVII-deficient patients, we evaluated its effect on the expression of FVII in a patient with severe FVII deficiency (undetectable FVII activity and antigen) carrying two additional homozygous missense variations (p.Arg277Cys and p.Arg353Gln). The two substitutions alone reduced the expression of FVII activity and antigen in vitro, but with the insertion polymorphism in our expression vector the patient's phenotype of undetectable plasma FVII was recapitulated. The insertion polymorphism in the 3' untranslated region of F7 is another modifier of FVII expression that might explain the poor genotype-phenotype correlation in some FVII-deficient patients. Copyright 2005 Wiley-Liss, Inc.

The insertional torque of a pedicle screw has a positive correlation with bone mineral density in posterior lumbar pedicle screw fixation.

PubMed

Lee, J H; Lee, J-H; Park, J W; Shin, Y H

2012-01-01

In patients with osteoporosis there is always a strong possibility that pedicle screws will loosen. This makes it difficult to select the appropriate osteoporotic patient for a spinal fusion. The purpose of this study was to determine the correlation between bone mineral density (BMD) and the magnitude of torque required to insert a pedicle screw. To accomplish this, 181 patients with degenerative disease of the lumbar spine were studied prospectively. Each underwent dual-energy x-ray absorptiometry (DEXA) and intra-operative measurement of the torque required to insert each pedicle screw. The levels of torque generated in patients with osteoporosis and osteopenia were significantly lower than those achieved in normal patients. Positive correlations were observed between BMD and T-value at the instrumented lumbar vertebrae, mean BMD and mean T-value of the lumbar vertebrae, and mean BMD and mean T-value of the proximal femur. The predictive torque (Nm) generated during pedicle screw insertion was [-0.127 + 1.62 × (BMD at the corresponding lumbar vertebrae)], as measured by linear regression analysis. The positive correlation between BMD and the maximum torque required to insert a pedicle screw suggests that pre-operative assessment of BMD may be useful in determining the ultimate strength of fixation of a device, as well as the number of levels that need to be fixed with pedicle screws in patients who are suspected of having osteoporosis.

Use of Contraindicated Antiplatelet Medications in the Setting of Percutaneous Coronary Intervention: Insights From the Veterans Affairs Clinical Assessment, Reporting, and Tracking Program.

PubMed

Barnes, Geoffrey D; Stanislawski, Maggie A; Liu, Wenhui; Barón, Anna E; Armstrong, Ehrin J; Ho, P Michael; Klein, Andrew; Maddox, Thomas M; Nallamothu, Brahmajee K; Rumsfeld, John S; Tsai, Thomas T; Bradley, Steven M

2016-07-01

Several antiplatelet medications used during and after percutaneous coronary intervention (PCI) are contraindicated for specific patient groups. A broad assessment of contraindicated medication use and associated clinical outcomes is not well described. Using national Veterans Affairs Clinical Assessment, Reporting, and Tracking Program data for all PCI between 2007 and 2013, we evaluated patients with contraindications to commonly used antiplatelet medications during and after PCI, defined in accordance with package inserts. Adjusted association between contraindicated medication use and outcomes of periprocedural bleeding and 30-day mortality were assessed using Cox proportional hazards with inverse probability weighting. Among 64 294 patients undergoing PCI, 11 315(17.6%) had a contraindication to a common antiplatelet medication and 737 (6.5%) of these patients received a contraindicated medication. In unadjusted analyses, any contraindicated medication use was associated with both increased bleeding and 30-day mortality. In adjusted models, contraindicated abciximab use in patients with thrombocytopenia (hazard ratio, 2.23; 95% confidence interval, 1.58-3.16) and in patients with a previous stroke (hazard ratio, 1.93; 95% confidence interval, 1.37-2.71) remained significantly associated with increased bleeding. Contraindicated abciximab use was not significantly associated with 30-day mortality in adjusted models. Use of eptifibatide in dialysis patients was not significantly associated with an increased risk of bleeding or mortality. In this national cohort, ≈18% of patients undergoing PCI had contraindications to common antiplatelet medications. Approximately 6% of those patients received a contraindicated medication with attendant bleeding risk, although this did not translate into significantly higher risk of 30-day mortality. Continued efforts to reduce contraindicated medication use may help avoid periprocedural complications. © 2016 American Heart Association, Inc.

Treatment for insertional Achilles tendinopathy: a systematic review.

PubMed

Wiegerinck, J I; Kerkhoffs, G M; van Sterkenburg, M N; Sierevelt, I N; van Dijk, C N

2013-06-01

Systematically search and analyse the results of surgical and non-surgical treatments for insertional Achilles tendinopathy. A structured systematic review of the literature was performed to identify surgical and non-surgical therapeutic studies reporting on ten or more adults with insertional Achilles tendinopathy. MEDLINE, CINAHL, EMBASE (Classic) and the Cochrane database of controlled trials (1945-March 2011) were searched. The Coleman methodology score was used to assess the quality of included articles, and these were analysed with an emphasis on change in pain score, patient satisfaction and complication rate. Of 451 reviewed abstracts, 14 trials met our inclusion criteria evaluating 452 procedures in 433 patients. Five surgical techniques were evaluated; all had a good patient satisfaction (avg. 89 %). The complication ratio differed substantially between techniques. Two studies analysed injections showing significant decrease in visual analogue scale (VAS). Eccentric exercises showed a significant decrease in VAS, but a large group of patients was unsatisfied. Extracorporeal shockwave therapy (ESWT) was superior to both wait-and-see and an eccentric training regime. One study evaluated laser CO(2), TECAR and cryoultrasound, all with significant decrease in VAS. Despite differences in outcome and complication ratio, the patient satisfaction is high in all surgical studies. It is not possible to draw conclusions regarding the best surgical treatment for insertional Achilles tendinopathy. ESWT seems effective in patients with non-calcified insertional Achilles tendinopathy. Although both eccentric exercises resulted in a decrease in VAS score, full range of motion eccentric exercises shows a low patient satisfaction compared to floor level exercises and other conservative treatment modalities.

Effect of six types of footwear on peak plantar pressures in patients with diabetes and transmetatarsal amputation.

PubMed

Mueller, MJ; Strube, MJ; Allen, BT

1997-04-01

INTRODUCTION:: Patients with diabetes (DM) and transmetatarsal amputation (TMA) are at high risk for skin breakdown from excessive peak plantar pressures (PPP). The primary purpose of this study was to determine how footwear (full length shoe or short shoe), a total contact insert, a rigid-rocker bottom (RRB) sole, and an ankle-foot-orthosis (AFO) affect PPP on the distal residuum and contralateral extremity of patients with DM and TMA. A secondary purpose was to monitor various functional measures during use of the footwear. METHODS:: Thirty patients with DM and TMA participated (mean age 62+/-4 years). The mean duration of DM was 19.9+/-10.1 years, and the mean time since TMA was 27.4+/-28.1 months. The following footwear was provided after a check-out from an orthotist and physical therapist (PT); 1) Full length shoe (ie shoe length prior to surgery), with a toe filler, 2) full length shoe, total contact insert, and an AFO, 2) full length shoe, total contact insert, and an AFO, 3) full length shoe, total contact insert, and a RRB sole, 4) full length shoe, total contact insert, RRB sole, and an AFO, 5) short shoe (ie length of residuum), total contact insert, and RRB, 6) short shoe, total contact insert, AFO, and RRB sole. In-shoe PPP during walking at the distal residuum and forefoot of the contralateral extremity were measured using the F-Scan System with established reliability under similar conditions (Generilizability coefficient =.75). Each measurement occurred after a one month adjustment period. Data were analyzed using a univariate repeated measuresANOVA. Individual contrasts were used for post-hoc analysis on those variables showing a significant overall F value (p<.05). RESULTS:: Compared to a regular shoe with a toe-filler, all conditions except the short shoe (#5), resulted in lower PPP on the distal residuum (p<.05). Condition 3, the full length shoe, total contact insert, and RRB resulted in lower pressures on the distal residuum and forefoot of the contralateral extremity compared to a regular shoe and toe-filler, and had few functional complaints as identified by the patient, orthotist or PT (3/27). Footwear using an AFO (Conditions 2,4,6) showed reduced PPP on the residuum, but most patients (16/29) had functional complaints. The short shoe (condition 5) had the fewest[Table: see text] functional complaints (2/26), but did not significantly reduce PPP and had the highest cosmetic refusal rate (5/26). DISCUSSION AND CONCLUSIONS:: Although there are individual patient characteristics which warrant other prescriptions, based on the results of this study, we recommend the full length shoe, total contact insert, and RRB sole for most patients with DM and TMA to reduce PPP. A reduction in PPP should help to lower the high risk of skin breakdown in this patient population.

IUD knowledge and experience among family medicine residents.

PubMed

Schubert, Finn D; Herbitter, Cara; Fletcher, Jason; Gold, Marji

2015-06-01

The intrauterine device (IUD) is a highly effective contraceptive method with few contraindications; however, clinician lack of training in insertion and misconceptions about IUD risks are barriers to utilization. Previous research has shown gaps in IUD training in family medicine residency programs. An online survey addressing experience with IUD insertion, knowledge of patient eligibility and IUD risks, and intent to insert IUDs in practice was circulated to residents at 15 US family medicine residency programs. Programs were eligible to participate if they were receiving funding to enhance training in family planning and abortion care and interested in additional support to enhance IUD training. The overall response rate for the surveys was 76.1% (332/436). Experience with the levonorgestrel intrauterine system was more common than with the copper IUD. Residents performed well on knowledge questions, but many would not insert in common patient scenarios in which insertion was not contraindicated, including a history of sexually transmitted infection in the past 6 months (48.2% would not insert), a history of ectopic pregnancy (37.0%), no pap smear in the past year (30.7%), or if the patient was not in a monogamous relationship (29.2%). The vast majority of residents (88.7%) reported that they were likely or very likely to provide IUDs in their future family medicine practice. Although residents overwhelmingly expressed interest in providing IUDs after residency, our results suggest that additional clinical and didactic training is needed, particularly interventions targeted at dispelling misconceptions about patient eligibility for IUDs.

Placement of Intubating Laryngeal Mask Airway Is Easier than Placement of Laryngeal Tube during Manual In-Line Stabilisation of The Neck

PubMed Central

Komatsu, R.; Nagata, O.; Kamata, K.; Yamagata, K.; Sessler, D.I.; Ozaki, M.

2005-01-01

Summary We compared the usefulness of the laryngeal tube (LT) with the intubating laryngeal mask airway (ILMA) in 51 patients whose necks were stabilised by manual in-line traction. After induction of anaesthesia and neuromuscular block, the LT and ILMA were inserted consecutively in a randomised, crossover design. During pressure-controlled ventilation (20 cmH2O inspiratory pressure), we measured insertion attempts, time to establish positive-pressure ventilation, tidal volume, gastric insufflation, and minimum airway pressure at which gas leaked around the cuff. Data were compared using Wilcoxon signed-rank tests; P<0.05 was considered significant. Insertion was more difficult with the LT (successful at first attempt in 16 patients) than with the ILMA (successful at first attempt in 42 patients, P<0.0001). Time required for insertion was longer for the LT (28 [23–35] sec, median [interquartile range]) than the ILMA (20 [15–25] sec, P=0.0009). Tidal volume was less for the LT (440 [290–670] ml) than the ILMA. (630 [440–750] ml, P=0.013). Minimum airway pressure at which gas leak occurred and incidence of gastric insufflation were similar with two devices. In patients whose necks were stabilised with manual in-line traction, insertion of the ILMA was easier and quicker than insertion of the LT and tidal volume was greater with the ILMA than the LT. PMID:15644005

Gait Parameters and Functional Outcomes After Total Knee Arthroplasty Using Persona Knee System With Cruciate Retaining and Ultracongruent Knee Inserts.

PubMed

Rajgopal, Ashok; Aggarwal, Kalpana; Khurana, Anshika; Rao, Arun; Vasdev, Attique; Pandit, Hemant

2017-01-01

Total knee arthroplasty is a well-established treatment for managing end-stage symptomatic knee osteoarthritis. Currently, different designs of prostheses are available with majority ensuring similar clinical outcomes. Altered surface geometry is introduced to strive toward gaining superior outcomes. We aimed to investigate any differences in functional outcomes between 2 different polyethylene designs namely the Persona CR (cruciate retaining) and Persona UC (ultracongruent) tibial inserts (Zimmer-Biomet, Warsaw, IN). This prospective single blind, single-surgeon randomized controlled trial reports on 105 patients, (66 female and 39 male), who underwent simultaneous bilateral total knee arthroplasty using the Persona knee system (Zimmer-Biomet) UC inserts in one side and CR inserts in the contralateral side. By a blind assessor, at regular time intervals patients were assessed in terms of function and gait. The functional knee scoring scales used were the Western Ontario and McMaster Universities Osteoarthritis Index and Modified Knee Society Score. The gait parameters evaluated were foot pressure and step length. During the study period, no patient was lost to follow-up or underwent revision surgery for any cause. Western Ontario and McMaster Universities Osteoarthritis Index scores, Modified Knee Society Score, and knee range of motion of all 105 patients assessed preoperatively and postoperatively at 6 months, 1 year, and 2 years showed statistically better results (P < .05) for UC inserts. Gait analysis measuring foot pressures and step length, however, did not show any statistically significant differences at 2-year follow-up. Ultracongruent tibial inserts show significantly better functional outcomes as compared to CR inserts during a 2-year follow-up period. However, in this study these findings were not shown to be attributed to differences in gait parameters. Copyright © 2016 Elsevier Inc. All rights reserved.

Risk factors for central venous catheter thrombotic complications in children and adolescents with cancer.

PubMed

Revel-Vilk, S; Yacobovich, J; Tamary, H; Goldstein, G; Nemet, S; Weintraub, M; Paltiel, O; Kenet, G

2010-09-01

The use of central venous catheters (CVCs) has greatly improved the quality of care in children with cancer, yet these catheters may cause serious infectious and thrombotic complications. The aim of this prospective registry study was to assess the host and CVC-related risk factors for CVC-created thrombotic complications. Patients undergoing CVC insertion for chemotherapy were followed prospectively for CVC complications. At the time of enrollment, demographic, clinical, and CVC-related data, and family history of thrombosis were collected. Survival and Cox regression analyses were performed. A total of 423 CVCs were inserted into 262 patients for a total of 76,540 catheter days. The incidence of CVC-related deep-vein thrombosis (DVT) was 0.13 per 1000 catheter-days (95% confidence interval [CI], 0.06-0.24). Insertion of peripherally inserted central catheters (PICCs) and insertion in an angiography suite significantly increased the risk of symptomatic CVC-related DVT. The incidence of CVC occlusion was 1.35 per 1000 catheter-days (95% CI, 1.1-1.63). Positive family history of thrombosis significantly increased the risk of CVC occlusion (hazard ratio [HR], 2.16; 95% CI, 1.2-3.8). The CVC-related risk factors were insertion of Hickman catheters, insertion in angiography suite, and proximal-tip location. Patients developing at least 1 episode of both CVC occlusion and infection had an increased risk for developing symptomatic CVC-related DVT (HR, 4.15; 95% CI, 1.2-14.4). Both patient-related and CVC-related factors are associated with higher risk of symptomatic thrombotic complications. These risk factors could be used in the clinical setting and in developing future studies for CVC thromboprophylaxis.

Nursing care as a predictor of phlebitis related to insertion of a peripheral venous cannula in emergency departments: findings from a prospective study.

PubMed

Palese, A; Ambrosi, E; Fabris, F; Guarnier, A; Barelli, P; Zambiasi, P; Allegrini, E; Bazoli, L; Casson, P; Marin, M; Padovan, M; Picogna, M; Taddia, P; Salmaso, D; Chiari, P; Marognolli, O; Canzan, F; Saiani, L

2016-03-01

To date, few studies have investigated the occurrence of phlebitis related to insertion of a peripheral venous cannula (PVC) in an emergency department (ED). To describe the natural history of ED-inserted PVC site use; the occurrence and severity of PVC-related phlebitis; and associations with patient, PVC and nursing care factors. A prospective study was undertaken of 1262 patients treated as urgent cases in EDs who remained in a medical unit for at least 24h. The first PVC inserted was observed daily until its removal; phlebitis was measured using the Visual Infusion Phlebitis Scale. Data on patient, PVC, nursing care and organizational variables were collected, and a time-to-event analysis was performed. The prevalence of PVC-related phlebitis was 31%. The cumulative incidence (78/391) was almost 20% three days after insertion, and reached >50% (231/391) five days after insertion. Being in a specialized hospital [hazard ratio (HR) 0.583, 95% confidence interval (CI) 0.366-0.928] and receiving more nursing care (HR 0.988, 95% CI 0.983-0.993) were protective against PVC-related phlebitis at all time points. Missed nursing care increased the incidence of PVC-related phlebitis by approximately 4% (HR 1.038, 95% CI 1.001-1.077). Missed nursing care and expertise of the nurses caring for the patient after PVC insertion affected the incidence of phlebitis; receiving more nursing care and being in a specialized hospital were associated with lower risk of PVC-related phlebitis. These are modifiable risk factors of phlebitis, suggesting areas for intervention at both hospital and unit level. Copyright © 2015 The Healthcare Infection Society. Published by Elsevier Ltd. All rights reserved.

Norwegian elderly patients' need for drug information and attitudes towards medication use reviews in community pharmacies.

PubMed

Mamen, Anette Vik; Håkonsen, Helle; Kjome, Reidun L S; Gustavsen-Krabbesund, Bjørn; Toverud, Else-Lydia

2015-12-01

Medication use review (MUR) is a community pharmacy service in several countries. Knowledge about what patients want from such a service is limited. The aim of this study was therefore to investigate Norwegian elderly patients' need for drug information and their attitudes towards MURs. In Norway's two largest cities, 162 patients (72% women; mean age: 78.9 years) who used at least one prescription drug were recruited from 18 senior centres. They were interviewed personally with a structured questionnaire (29 closed and 4 open-ended questions). The average number of prescription drugs used was 4.4. Seventy per cent also used over-the-counter drugs. The main source of drug information was the general practitioner (GP) followed by package inserts and pharmacy staff. For drug-related problems, 62% would contact the GP compared with 24% who preferred the pharmacist. Fifty per cent remembered no information when collecting prescriptions. However, 56% wanted to know more about their medication and 55% were interested in a MUR. The main topics they wished to address were effect/side effects and interactions. Lack of privacy was reported to be a major obstacle in the current situation. This study shows that community pharmacies in Norway play a minor role regarding drug information to elderly polypharmacy patients. The GP is both their main information source and whom they contact for drug-related problems. However, half of the patients would like to know more about their medication. More than half were positive towards taking part in a MUR. © 2015 Royal Pharmaceutical Society.

High-performance and high-reliability SOT-6 packaged diplexer based on advanced IPD fabrication techniques

NASA Astrophysics Data System (ADS)

Qiang, Tian; Wang, Cong; Kim, Nam-Young

2017-08-01

A diplexer offering the advantages of compact size, high performance, and high reliability is proposed on the basis of advanced integrated passive device (IPD) fabrication techniques. The proposed diplexer is developed by combining a third-order low-pass filter (LPF) and a third-order high-pass filter (HPF), which are designed on the basis of the elliptic function prototype low-pass filter. Primary components, such as inductors and capacitors, are designed and fabricated with high Q-factor and appropriate values, and they are subsequently used to construct a compact diplexer having a chip area of 900 μm × 1100 μm (0.009 λ0 × 0.011 λ0, where λ0 is the guided wavelength). In addition, a small-outline transistor (SOT-6) packaging method is adopted, and reliability tests (including temperature, humidity, vibration, and pressure) are conducted to guarantee long-term stability and commercial success. The packaged measurement results indicate excellent RF performance with insertion losses of 1.39 dB and 0.75 dB at operation bands of 0.9 GHz and 1.8 GHz, respectively. The return loss is lower than 10 dB from 0.5 GHz to 4.0 GHz, while the isolation is higher than 15 dB from 0.5 GHz to 3.0 GHz. Thus, it can be concluded that the proposed SOT-6 packaged diplexer is a promising candidate for GSM/CDMA applications. Synthetic solution of diplexer design, RF performance optimization, fabrication process, packaging, RF response measurement, and reliability test is particularly explained and analyzed in this work.

A Mutation in UL15 of Herpes Simplex Virus 1 That Reduces Packaging of Cleaved Genomes▿

PubMed Central

Yang, Kui; Wills, Elizabeth G.; Baines, Joel D.

2011-01-01

Herpesvirus genomic DNA is cleaved from concatemers that accumulate in infected cell nuclei. Genomic DNA is inserted into preassembled capsids through a unique portal vertex. Extensive analyses of viral mutants have indicated that intact capsids, the portal vertex, and all components of a tripartite terminase enzyme are required to both cleave and package viral DNA, suggesting that DNA cleavage and packaging are inextricably linked. Because the processes have not been functionally separable, it has been difficult to parse the roles of individual proteins in the DNA cleavage/packaging reaction. In the present study, a virus bearing the deletion of codons 400 to 420 of UL15, encoding a terminase component, was analyzed. This virus, designated vJB27, failed to replicate on noncomplementing cells but cleaved concatemeric DNA to ca. 35 to 98% of wild-type levels. No DNA cleavage was detected in cells infected with a UL15-null virus or a virus lacking UL15 codons 383 to 385, comprising a motif proposed to couple ATP hydrolysis to DNA translocation. The amount of vJB27 DNA protected from DNase I digestion was reduced compared to the wild-type virus by 6.5- to 200-fold, depending on the DNA fragment analyzed, thus indicating a profound defect in DNA packaging. Capsids containing viral DNA were not detected in vJB27-infected cells, as determined by electron microscopy. These data suggest that pUL15 plays an essential role in DNA translocation into the capsid and indicate that this function is separable from its role in DNA cleavage. PMID:21880766

[Peripherally inserted central catheter antibiotic therapy for cystic fibrosis patients].

PubMed

Betegnie, A-L; Cracowski, C; Bedouch, P; Segond, C; Robein-Dobremez, M-J; Pin, I; Allenet, B

2014-11-01

Peripherally inserted central catheters (PICC) are more and more used for intravenous antibiotic infusions in cystic fibrosis (CF) patients in the Grenoble area (France). The aim of this study was to assess the use of this technique in this indication. 1. Retrospective evaluation of 102 consecutive PICC insertions over 3years and the incidence of adverse events during the therapy. 2. Prospective evaluation of 12 patient's satisfaction and their nurses over a 3-month period. 3. Comparative analysis of single domiciliary treatment costs using PICC versus peripheral catheter (PC). 102 PICC insertions were attempted in 31 patients. Seven failures and 7 complications occurred during the treatment requiring removal of the PICC, i.e. an overall success rate of 86.2% (88/102). Pain during PICC introduction was 4.2/10 (visual analogical scale). Mean satisfaction levels during therapy were 9.3/10 for patients and 8.7/10 for nurses. Compared with PC, all the patients said that PICC was "more comfortable". Differential costs of treatment with PC and with PICC at home were estimated at 57.15€ and 590.16€ respectively. PICC is an alternative to CP for intravenous antibiotherapy in CF patients, providing better safety and comfort. PICC use should be promoted in this indication. Copyright © 2013 SPLF. Published by Elsevier Masson SAS. All rights reserved.

Penile Lengthening, Girth, and Size Preservation at the Time of Penile Prosthesis Insertion.

PubMed

Tran, Henry; Goldfarb, Robert; Ackerman, Anika; Valenzuela, Robert J

2017-07-01

Penile prosthetic devices are the gold standard treatment of medication-refractory erectile dysfunction. Inflatable penile prosthetic (IPP) devices have been available and used for more than four decades. Oftentimes, medical conditions causing erectile dysfunction also cause penile shortening, causing decreased patient quality of life. To identify and review all available penile lengthening procedures that can be performed at time of IPP insertion. An extensive, systematic literature review was performed using PubMed searching for key terms penile lengthening, inflatable penile prosthesis, penile girth, corporoplasty, glans augmentation, and penile enhancement; all articles with subjective and/or objective penile length outcomes were reviewed. A review of various techniques for penile length and girth preservation and enhancement during penile prosthesis insertion. Several advanced and novel techniques were found for penile length preservation and enhancement at time of IPP insertion, including the sub-coronal IPP insertion technique, and adjuvant maneuvers during insertion, such as the sliding technique, modified sliding technique, multiple slice technique, and circumferential incision and grafting. Other adjuvant techniques that can enhance perception of increased length include ventral phalloplasty, suprapubic lipectomy, and suspensory ligament release. Further enhancement can be obtained using augmentation corporoplasty and glans augmentation with hyaluronic acid and other fillers. The different techniques vary in complexity and could require specialized training and experience. Maximum length gain appears to be limited by the length of the neurovascular bundles. Overall, surgical penile lengthening procedures at time of IPP insertion appear safe and effective for treatment of patients with penile shortening and severe erectile dysfunction. These therapies can significantly improve patient self-esteem and quality of life in properly selected patients. Tran H, Goldfarb R, Ackerman A, Valenxuela RJ. Penile Lengthening, Girth and Size Preservation at the Time of Penile Prosthesis Insertion. Sex Med Rev 2017;5:403-412. Copyright © 2017 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.

OptoZIF Drive: a 3D printed implant and assembly tool package for neural recording and optical stimulation in freely moving mice

NASA Astrophysics Data System (ADS)

Freedman, David S.; Schroeder, Joseph B.; Telian, Gregory I.; Zhang, Zhengyang; Sunil, Smrithi; Ritt, Jason T.

2016-12-01

Objective. Behavioral neuroscience studies in freely moving rodents require small, light-weight implants to facilitate neural recording and stimulation. Our goal was to develop an integrated package of 3D printed parts and assembly aids for labs to rapidly fabricate, with minimal training, an implant that combines individually positionable microelectrodes, an optical fiber, zero insertion force (ZIF-clip) headstage connection, and secondary recording electrodes, e.g. for electromyography (EMG). Approach. Starting from previous implant designs that position recording electrodes using a control screw, we developed an implant where the main drive body, protective shell, and non-metal components of the microdrives are 3D printed in parallel. We compared alternative shapes and orientations of circuit boards for electrode connection to the headstage, in terms of their size, weight, and ease of wire insertion. We iteratively refined assembly methods, and integrated additional assembly aids into the 3D printed casing. Main results. We demonstrate the effectiveness of the OptoZIF Drive by performing real time optogenetic feedback in behaving mice. A novel feature of the OptoZIF Drive is its vertical circuit board, which facilities direct ZIF-clip connection. This feature requires angled insertion of an optical fiber that still can exit the drive from the center of a ring of recording electrodes. We designed an innovative 2-part protective shell that can be installed during the implant surgery to facilitate making additional connections to the circuit board. We use this feature to show that facial EMG in mice can be used as a control signal to lock stimulation to the animal’s motion, with stable EMG signal over several months. To decrease assembly time, reduce assembly errors, and improve repeatability, we fabricate assembly aids including a drive holder, a drill guide, an implant fixture for microelectode ‘pinning’, and a gold plating fixture. Significance. The expanding capability of optogenetic tools motivates continuing development of small optoelectric devices for stimulation and recording in freely moving mice. The OptoZIF Drive is the first to natively support ZIF-clip connection to recording hardware, which further supports a decrease in implant cross-section. The integrated 3D printed package of drive components and assembly tools facilities implant construction. The easy interfacing and installation of auxiliary electrodes makes the OptoZIF Drive especially attractive for real time feedback stimulation experiments.

The role of Toujeo®, insulin glargine U-300, in the treatment of diabetes mellitus.

PubMed

Brown, Meagan A; Davis, Courtney S; Fleming, Laurie W; Fleming, Joshua W

2016-09-01

The purpose of this article is to educate nurse practitioners about the role of Toujeo®, insulin glargine U-300 (Gla-300), which is a new option for the treatment of diabetes mellitus. A comprehensive literature search was conducted using MEDLINE with the key terms: insulin glargine 300, Toujeo, Gla-300, and EDITION for clinical trial data. Other resources included package inserts, drug information websites, and the World Health Organization (WHO). Gla-300 appears to be a safe and effective option for basal insulin therapy. In clinical trials, it was shown to be equally efficacious as Gla-100 with fewer episodes of hypoglycemia and slightly less weight gain, and subjects receiving Gla-300 required approximately 10 units more basal insulin to obtain the same hemoglobin A1c (HbA1c) as subjects receiving Gla-100. This new basal therapy option represents a potential advantage for patients who require higher doses of insulin because of the higher concentration of Gla-300. The lower incidence of hypoglycemia and more predictable pharmacokinetics could offer a significant therapeutic benefit in difficult-to-control patients with diabetes mellitus. The biggest disadvantage of this product is the slightly higher insulin dosage that is required to improve and/or maintain patients' HbA1c. ©2016 American Association of Nurse Practitioners.

Pedicle screw placement using image guided techniques.

PubMed

Merloz, P; Tonetti, J; Pittet, L; Coulomb, M; Lavalleé, S; Sautot, P

1998-09-01

Clinical evaluation of a computer assisted spine surgical system is presented. Eighty pedicle screws were inserted using computer assisted technology in thoracic and lumbar vertebrae for treatment of different types of disorders including fractures, spondylolisthesis, and scoliosis. Fifty-two patients with severe fractures, spondylolisthesis, or pseudoarthrosis of T10 to L5 were treated using a computer assisted technique on 1/2 the patients and performing the screw insertion manually for the other 1/2. At the same time, 28 pedicle screws were inserted in T12 to L4 vertebrae for scoliosis with the help of the computer assisted technique. Surgery was followed in all cases (66 vertebrae; 132 pedicle screws) by postoperative radiographs and computed tomographic examination, on which measurements of screw position relative to pedicle position could be done. For fractures, spondylolisthesis, or pseudarthrosis, comparison between the two groups showed that four screws in 52 (8%) vertebrae had incorrect placement with computer assisted technique whereas 22 screws in 52 (42%) vertebrae had incorrect placement with manual insertion. In patients with scoliosis, four screws in 28 (14%) vertebrae had incorrect placement. In all of the patients (132 pedicle screws) there were no neurologic complications. These results show that a computer assisted technique is much more accurate and safe than manual insertion.

Agents for facilitation of laryngeal mask airway insertion: a comparative study between thiopentone sodium and propofol.

PubMed

Sengupta, Janmejoy; Sengupta, Mohua; Nag, Tulsi

2014-01-01

Development of endotracheal intubation to avoid deleterious effect on hemodynamic responses occurring during laryngoscopy and intubation compelled researchers to venture into alternative measures of airway management with subtle hemodynamic responses. This study was carried out to compare the conditions for laryngeal mask airways LMA insertion with widely used intravenous induction agents, thiopentone sodium and propofol, and also to compare the undesired responses occurring during LMA insertion with them. The study was prospective, randomized, and double blind. All patients selected were randomly allocated into two groups: Group 1 (propofol) and group II (thiopentone). Preinduction heart rate and blood pressure were recorded. Sixty healthy adult patients of either sex belonging to age group of 20-60 years and ASA grade I or II, to undergo surgery less than 1 h, were selected for the study-Patients were randomly allocated in two groups, 30 in each group. Premedication with midazolam 0.04 mg/kg and fentanyl 2 mg/kg done in both groups. Thereafter, group 1 was induced with 2 mg/kg of propofol and group 2 with 5 mg/kg of thiopentone sodium. The study revealed that, ease of insertion of LMA, was statistically significantly greater in group 1 when compared with group 2 (P 0.05). The time required for successful insertion of LMA was lesser in group 1 patients (53.8 ± 7.77 s) than in group 2 patients (84.7 ± 16.54 s) (P 0.001). Severity of undesired responses were more in group 2, as incremental boluses of respective induction agents were required in 20% patients in thiopentone group compared to only 6% patients in propofol group and 13% of patients in thiopentone group required rescue succinylcholine.

Insertion of Balloon Retained Gastrostomy Buttons: A 5-Year Retrospective Review of 260 Patients

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

Power, Sarah, E-mail: sarahpower28@yahoo.co.uk; Kavanagh, Liam N.; Shields, Mary C.

Radiologically inserted gastrostomy (RIG) is an established way of maintaining enteral nutrition in patients who cannot maintain nutrition orally. The purpose of this study was to evaluate the safety and efficacy of primary placement of a wide bore button gastrostomy in a large, varied patient population through retrospective review. All patients who underwent gastrostomy placement from January 1, 2004 to January 1, 2009 were identified. 18-Fr gastrostomy buttons (MIC-Key G) were inserted in the majority. Follow-up ranged from 6 months to 4.5 years. A total of 260 patients (M:F 140:120, average age 59.2 years) underwent gastrostomy during the study period.more » Overall success rate for RIG placement was 99.6 %, with success rate of 95.3 % for primary button insertion. Indications included neurological disorders (70 %), esophageal/head and neck malignancy (21 %), and other indications (9 %). Major and minor complication rates were 1.2 and 12.8 %, respectively. Thirty-day mortality rate was 6.8 %. One third of patients underwent gastrostomy reinsertion during the study period, the main indication for which was inadvertent catheter removal. Patency rate was high at 99.5 %. The maximum number of procedures in any patient was 8 (n = 2), and the average tube dwell time was 125 days. Primary radiological insertion of a wide bore button gastrostomy is a safe technique, with high success rate, high patency rate, and low major complication rate. We believe that it is feasible to attempt button gastrostomy placement in all patients, once tract length is within limits of tube length. If difficulty is encountered, then a standard tube may simply be placed instead.« less

Advantages and disadvantages of surgical placement of PD catheters with regard to other methods.

PubMed

Stegmayr, B

2006-01-01

Peritoneal dialysis is underused for various reasons. One reason may be problems with insertion of catheters for access. Another reason is the delayed start (break-in period) of about 2 weeks after operation. This review describes various approaches to the insertion of a peritoneal dialysis catheter. The optimal conditions to strive for are given as is an overview of various techniques. This article favours surgical placement while others might prefer other techniques. Described is the use a 3-purse string suture technique that allows immediate start of dialysis after catheter insertion both for acute dialysis indications as well as for acute start in chronic dialysis patients. A key to lesser complications is to establish a team devoted to the insertions rather than to allow various physicians to perform insertions as a training procedure. An optimal access is one of the important life lines for these patients.

PIP silicone breast implants: rupture rates based on the explantation of 676 implants in a single surgeon series.

PubMed

Quaba, Omar; Quaba, Awf

2013-09-01

To determine the true rupture rates of PIP implants from a large single surgeon cohort and to assess whether rupture rates varied depending on time of implant insertion. In addition, the efficacy of ultra sound scanning (USS) in determining rupture is examined. Predominantly prospectively based analysis of patient records, investigations and surgical findings. 338 patients (676 implants) were included in the study and they all had removal of their implants. The senior author operated on all patients at some stage of their treatment. 160 patients were imaged pre-operatively with USS. Patients had implants inserted between 1999 and 2007 for cosmetic breast augmentation. A total of 144 ruptured implants were removed from 119 patients, giving a rupture rate of 35.2% per patient and 21.3% per implant over a mean implantation period of 7.8 years. A statistical difference (P < 0.001) in rupture rates between implants inserted prior to 2003 and those inserted from 2003 was demonstrated, with higher failure rates in the latter group. There was a significant difference in rupture rates depending on pocket placement of the implants. The sensitivity and specificity of USS at detecting rupture was 90.6% and 98.3% respectively. A proportion of patients (29.4%) demonstrated loco-regional spread of silicone to the axilla on scanning. Our paper has confirmed high rates of PIP implant failure in the largest published series to date. The significant difference in rupture rates between implants inserted prior to 2003 and those after this time supports the view that industrial silicone was used in the devices after 2003. Implants are more likely to rupture if inserted in the sub muscular plane compared to the sub glandular plane. USS is highly effective at detecting rupture in PIP implants and loco-regional spread is high compared to other devices. We believe this paper provides hard data enabling more informed decision making for patients, clinicians and providers in what remains an active issue affecting thousands of women. Copyright © 2013 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.

A multicenter comparison of intraaortic balloon pump utilization in isolated coronary artery bypass graft surgery.

PubMed

Baskett, Roger J F; O'Connor, Gerald T; Hirsch, Gregory M; Ghali, William A; Sabadosa, Kathy; Morton, Jeremy R; Ross, Cathy S; Hernandez, Felix; Nugent, William C; Lahey, Stephen J; Sisto, Donato A; Dacey, Lawrence J; Klemperer, John D; Helm, Robert E; Maitland, Andrew

2003-12-01

Single-center studies suggest substantial variation in intraaortic balloon pump (IABP) utilization. Our purpose is to examine IABP utilization over time and across medical centers. This was a prospective cohort of 29,961 consecutive patients undergoing isolated coronary artery bypass graft surgery, between 1995 and 2000, at 10 centers (eight in northern New England and two in Canada). A total of 2,678 (8.9%) patients received an IABP. The rate of preoperative IABP insertion was 6.3%, and that of intra- or postoperative insertion was 2.6%. During the 6 years, IABP use increased from 7.0% to 10.3% (p(trend) <0.001). Preoperative IABP insertion increased from 5.4% to 7.8% (p(trend) < 0.001). There was no significant increase in intra-/postoperative IABP insertion 1.7% to 3.4% (p(trend) = 0.34). Adjustment for changes in patient and disease characteristics did not substantially alter these results. The rate of IABP use varied substantially by center, from 5.9% to 16.4% (p < 0.001). Adjustment for patient and disease characteristics resulted in variation from 4.8% to 12.8% across the 10 centers (p < 0.001). The adjusted rates of preoperative IABP insertion varied from 3.6% to 13.7% (p < 0.001), and the rates of intra-/postoperative IABP insertion ranged from 1.0% to 5.2% (p < 0.001). There was no significant correlation between the rates of preoperative and intra-/postoperative IABP use (r(s) = 0.085, p = 0.815). During the 6 years, there was a 47% increase in the rate of IABP utilization. Even after adjustment, there was almost threefold variation in IABP use across centers. This variation likely reflects lack of consensus on the appropriate use of the IABP in CABG patients.

Comparison of Perfusion CT Software to Predict the Final Infarct Volume After Thrombectomy.

PubMed

Austein, Friederike; Riedel, Christian; Kerby, Tina; Meyne, Johannes; Binder, Andreas; Lindner, Thomas; Huhndorf, Monika; Wodarg, Fritz; Jansen, Olav

2016-09-01

Computed tomographic perfusion represents an interesting physiological imaging modality to select patients for reperfusion therapy in acute ischemic stroke. The purpose of our study was to determine the accuracy of different commercial perfusion CT software packages (Philips (A), Siemens (B), and RAPID (C)) to predict the final infarct volume (FIV) after mechanical thrombectomy. Single-institutional computed tomographic perfusion data from 147 mechanically recanalized acute ischemic stroke patients were postprocessed. Ischemic core and FIV were compared about thrombolysis in cerebral infarction (TICI) score and time interval to reperfusion. FIV was measured at follow-up imaging between days 1 and 8 after stroke. In 118 successfully recanalized patients (TICI 2b/3), a moderately to strongly positive correlation was observed between ischemic core and FIV. The highest accuracy and best correlation are shown in early and fully recanalized patients (Pearson r for A=0.42, B=0.64, and C=0.83; P<0.001). Bland-Altman plots and boxplots demonstrate smaller ranges in package C than in A and B. Significant differences were found between the packages about over- and underestimation of the ischemic core. Package A, compared with B and C, estimated more than twice as many patients with a malignant stroke profile (P<0.001). Package C best predicted hypoperfusion volume in nonsuccessfully recanalized patients. Our study demonstrates best accuracy and approximation between the results of a fully automated software (RAPID) and FIV, especially in early and fully recanalized patients. Furthermore, this software package overestimated the FIV to a significantly lower degree and estimated a malignant mismatch profile less often than other software. © 2016 American Heart Association, Inc.

Idarucizumab (Praxbind) Formulary Review.

PubMed

Buchheit, Jessica; Reddy, Prabashni; Connors, Jean M

2016-09-01

Idarucizumab (Praxbind), a humanized monoclonal antibody fragment was granted accelerated approval from the Food and Drug Administration in October 2015 as the first agent to reverse the effects of a novel oral anticoagulant. The drug is indicated for dabigatran reversal in patients requiring emergency surgery/urgent procedures or with life-threatening or uncontrolled bleeding. In a randomized study with healthy volunteers, compared with placebo, idarucizumab reduced the clotting times for all tests assays (assessed pre-, end of-, and 24 hours after infusion), while the results for the placebo group remained unchanged. Another randomized clinical trial assessed the safety and efficacy of idarucizumab in patients with either overt bleeding or undergoing emergency surgery where hemostasis was required. This study is ongoing, but preliminary results showed reversal efficacy demonstrated a reasonable safety profile from the time of the infusion to 90 days after. The wholesale acquisition cost of two 2.5 g vials of idarucizumab is currently $3482.50. To treat 10 or 20 patients per year with a single 5 g dose is estimated to cost $34,825 and $69,650, respectively. In the clinical trial described above, approximately 20% of patients required a second dose, which would further increase the cost of use. In this formulary review for a health system's pharmacy and therapeutics committee, idarucizumab clinical trials and medication package insert were summarized and, after consulting with clinical experts from our institutions, practical recommendations for use were generated to ensure appropriate and safe use of this agent.

Accurate and Simple Screw Insertion Procedure With Patient-Specific Screw Guide Templates for Posterior C1-C2 Fixation.

PubMed

Sugawara, Taku; Higashiyama, Naoki; Kaneyama, Shuichi; Sumi, Masatoshi

2017-03-15

Prospective clinical trial of the screw insertion method for posterior C1-C2 fixation utilizing the patient-specific screw guide template technique. To evaluate the efficacy of this method for insertion of C1 lateral mass screws (LMS), C2 pedicle screws (PS), and C2 laminar screws (LS). Posterior C1LMS and C2PS fixation, also known as the Goel-Harms method, can achieve immediate rigid fixation and high fusion rate, but the screw insertion carries the risk of injury to neuronal and vascular structures. Dissection of venous plexus and C2 nerve root to confirm the insertion point of the C1LMS may also cause problems. We have developed an intraoperative screw guiding method using patient-specific laminar templates. Preoperative bone images of computed tomography (CT) were analyzed using three-dimensional (3D)/multiplanar imaging software to plan the trajectories of the screws. Plastic templates with screw guiding structures were created for each lamina using 3D design and printing technology. Three types of templates were made for precise multistep guidance, and all templates were specially designed to fit and lock on the lamina during the procedure. Surgery was performed using this patient-specific screw guide template system, and placement of the screws was postoperatively evaluated using CT. Twelve patients with C1-C2 instability were treated with a total of 48 screws (24 C1LMS, 20 C2PS, 4 C2LS). Intraoperatively, each template was found to exactly fit and lock on the lamina and screw insertion was completed successfully without dissection of the venous plexus and C2 nerve root. Postoperative CT showed no cortical violation by the screws, and mean deviation of the screws from the planned trajectories was 0.70 ± 0.42 mm. The multistep, patient-specific screw guide template system is useful for intraoperative screw navigation in posterior C1-C2 fixation. This simple and economical method can improve the accuracy of screw insertion, and reduce operation time and radiation exposure of posterior C1-C2 fixation surgery. 3.

'Stent in a stent'--an alternative technique for removing partially covered stents following sleeve gastrectomy complications.

PubMed

Vasilikostas, Georgios; Sanmugalingam, Nimalan; Khan, Omar; Reddy, Marcus; Groves, Chris; Wan, Andrew

2014-03-01

Endoscopic stenting is a relatively new technique for the treatment of post sleeve gastrectomy complications. Partially covered stents are used in this method to minimise the risk of migration but they are associated with difficulties with removal. Patients requiring emergency stenting following sleeve gastrectomy underwent insertion of a partially covered metallic stent. One month later, if the stent was not easily removable, a fully covered overlapping stent was inserted and the patient was readmitted 2 weeks later for removal of both stents. Four patients required stenting following sleeve gastrectomy leaks, and one patient required stenting for a stricture. In these cases, a 'stent in a stent' technique was used for removal. This technique allows the safe removal of partially covered stents inserted following sleeve gastrectomy complications.

Peripherally Inserted Central Catheters in Pediatric Oncology Patients: A 15-Year Population-based Review From Maritimes, Canada.

PubMed

Borretta, Lisa; MacDonald, Tamara; Digout, Carol; Smith, Nadine; Fernandez, Conrad V; Kulkarni, Ketan

2018-01-01

The present population-based study evaluates the management and complications of peripherally inserted central catheters (PICC) in all pediatric oncology patients diagnosed in Maritimes, Canada from 2000 to 2014. A total of 107 PICCs were placed in 87 (10.1%) pediatric oncology patients. A high percentage (33% and 44%, respectively) of the first and second PICC lines was associated with complications. Thrombosis, occlusion, and infection were the most frequent complications. Age above 10 years and left body side of insertion were significantly associated with PICC complications. Given the frequent use of PICCs and the high incidence (>33%) of complications, there is a need to mitigate PICC line complications.

Trochantoplasty for Total Hip Arthroplasty in Patients With Coxa Vara Deformity.

PubMed

Yoo, Jun-Il; Parvizi, Javad; Song, Ji-Ung; Ha, Yong-Chan; Lee, Young-Kyun; Koo, Kyung-Hoi

2017-07-01

In total hip arthroplasty (THA) of hips with coxa vara, the femoral stems might be inserted in a varus alignment. To avoid varus insertion, we designed a technique, which we termed "trochantoplasty." In this procedure, the medial half of the greater trochanter was removed during THA. We evaluated 30 patients (31 hips) who had coxa vara deformity and underwent THA using trochantoplasty at the mean follow-up of 5 years (range, 3-9 years). All stems were inserted in the neutral position. One Vancouver type 1 periprosthetic femoral fracture occurred after a fall at postoperative 2 months. At the latest follow-up, the mean power of abductor was 4.3 (range, 3-5). Four patients had moderate limp whereas 26 patients had slight limp. The abduction at 90° flexion ranged from 15° to 45° (mean, 35°). There was no revision. All prostheses had bone-ingrown stability without any detectable wear or osteolysis. The mean Harris hip score was improved from 66.9 to 89.4 points. Trochantoplasty can be used to avoid varus insertion of the femoral stem while performing THA in patients with coxa vara deformity without compromising the abductor mechanism. Copyright © 2017 Elsevier Inc. All rights reserved.

[Assessment of plantar fasciitis using shear wave elastography].

PubMed

Zhang, Lining; Wan, Wenbo; Zhang, Lihai; Xiao, Hongyu; Luo, Yukun; Fei, Xiang; Zheng, Zhixin; Tang, Peifu

2014-02-01

To assess the stiffness and thickness of the plantar fascia using shear wave elastography (SWE) in healthy volunteers of different ages and in patients with plantar fasciitis. The bilateral feet of 30 healthy volunteers and 23 patients with plantar fasciitis were examined with SWE. The plantar fascia thickness and elasticity modulus value were measured at the insertion of the calcaneus and at 1 cm from the insertion. The elderly volunteers had a significantly greater plantar fascia thickness measured using conventional ultrasound (P=0.005) and a significantly lower elasticity modulus value than the young volunteers (P=0.000). The patients with fasciitis had a significantly greater plantar fascia thickness (P=0.001) and a lower elasticity modulus value than the elderly volunteers (P=0.000). The elasticity modulus value was significantly lower at the calcaneus insertion than at 1 cm from the insertion in patients with fasciitis (P=0.000) but showed no significantly difference between the two points in the elderly or young volunteers (P=0.172, P=0.126). SWE allows quantitative assessment of the stiffness of the plantar fascia, which decreases with aging and in patients with plantar fasciitis.

I-gel insertion by novices in manikins and patients.

PubMed

Wharton, N M; Gibbison, B; Gabbott, D A; Haslam, G M; Muchatuta, N; Cook, T M

2008-09-01

The i-gel, a novel supraglottic airway, has been proposed for use during cardiopulmonary resuscitation. We evaluated the performance of this device in manikins and anaesthetised patients when used by novices: medical students, non-anaesthetist physicians and allied health professionals all unfamiliar with the i-gel. Fifty i-gels were placed in manikins. Eighty-eight percent (44/50) were placed on the first attempt with a median insertion time of 14 s (range 7-45). I-gels were placed in 40 healthy anaesthetised patients. Success on the first attempt was 82.5% (33/40) and on the second attempt 15% (6/40). After three attempts there were no failures. Median insertion time was 17.5 s (range 7-197). Median airway seal was 20 cmH(2)O (range 13-40). One case of regurgitation and partial aspiration occurred. Our results suggest the i-gel is rapidly inserted in both manikins and patients by novice users and compares favourably to other supraglottic airways available. Further work determining safety and efficacy during cardiopulmonary resuscitation is required.

Progress in performance enhancement methods for capacitive silicon resonators

NASA Astrophysics Data System (ADS)

Van Toan, Nguyen; Ono, Takahito

2017-11-01

In this paper, we review the progress in recent studies on the performance enhancement methods for capacitive silicon resonators. We provide information on various fabrication technologies and design considerations that can be employed to improve the performance of capacitive silicon resonators, including low motional resistance, small insertion loss, and high quality factor (Q). This paper contains an overview of device structures and working principles, fabrication technologies consisting of hermetic packaging, deep reactive-ion etching and neutral beam etching, and design considerations including mechanically coupled, movable electrode structures and piezoresistive heat engines.

Board-level optical clock signal distribution using Si CMOS-compatible polyimide-based 1- to 48-fanout H-tree

NASA Astrophysics Data System (ADS)

Wu, Linghui; Bihari, Bipin; Gan, Jianhua; Chen, Ray T.; Tang, Suning

1998-08-01

Si-CMOS compatible polymer-based waveguides for optoelectronic interconnects and packaging have been fabricated and characterized. A 1-to-48 fanout optoelectronic interconnection layer (OIL) structure based on Ultradel 9120/9020 for the high-speed massive clock signal distribution for a Cray T-90 supercomputer board has been constructed. The OIL employs multimode polymeric channel waveguides in conjunction with surface-normal waveguide output coupler and 1-to-2 splitter. A total insertion loss of 7.98 dB at 850 nm was measured experimentally.

Apollo 17

NASA Technical Reports Server (NTRS)

Garrett, David

1972-01-01

This is the Press Kit that was given to the various media outlets that were interested in covering the Apollo 17 mission. It includes information about the moon, lunar science, concentrating on the planned mission. The kit includes information about the flight, and the trajectory, planned orbit insertion maneuvers, the extravehicular mission events, a comparison with the Apollo 16, a map of the lunar surface, and the surface activity, information about the Taurus-Littrow landing site, the planned science experiments, the power source for the experiment package and diagrams of some of the instrumentation that was used to perform the experiments.

Superlattice structure modeling and simulation of High Electron Mobility Transistor for improved performance

NASA Astrophysics Data System (ADS)

Munusami, Ravindiran; Yakkala, Bhaskar Rao; Prabhakar, Shankar

2013-12-01

Magnetic tunnel junction were made by inserting the magnetic materials between the source, channel and the drain of the High Electron Mobility Transistor (HEMT) to enhance the performance. Material studio software package was used to design the superlattice layers. Different cases were analyzed to optimize the performance of the device by placing the magnetic material at different positions of the device. Simulation results based on conductivity reveals that the device has a very good electron transport due to the magnetic materials and will amplify very low frequency signals.

Cooperative heteroassembly of the adenoviral L4-22K and IVa2 proteins onto the viral packaging sequence DNA.

PubMed

Yang, Teng-Chieh; Maluf, Nasib Karl

2012-02-21

Human adenovirus (Ad) is an icosahedral, double-stranded DNA virus. Viral DNA packaging refers to the process whereby the viral genome becomes encapsulated by the viral particle. In Ad, activation of the DNA packaging reaction requires at least three viral components: the IVa2 and L4-22K proteins and a section of DNA within the viral genome, called the packaging sequence. Previous studies have shown that the IVa2 and L4-22K proteins specifically bind to conserved elements within the packaging sequence and that these interactions are absolutely required for the observation of DNA packaging. However, the equilibrium mechanism for assembly of IVa2 and L4-22K onto the packaging sequence has not been determined. Here we characterize the assembly of the IVa2 and L4-22K proteins onto truncated packaging sequence DNA by analytical sedimentation velocity and equilibrium methods. At limiting concentrations of L4-22K, we observe a species with two IVa2 monomers and one L4-22K monomer bound to the DNA. In this species, the L4-22K monomer is promoting positive cooperative interactions between the two bound IVa2 monomers. As L4-22K levels are increased, we observe a species with one IVa2 monomer and three L4-22K monomers bound to the DNA. To explain this result, we propose a model in which L4-22K self-assembly on the DNA competes with IVa2 for positive heterocooperative interactions, destabilizing binding of the second IVa2 monomer. Thus, we propose that L4-22K levels control the extent of cooperativity observed between adjacently bound IVa2 monomers. We have also determined the hydrodynamic properties of all observed stoichiometric species; we observe that species with three L4-22K monomers bound have more extended conformations than species with a single L4-22K bound. We suggest this might reflect a molecular switch that controls insertion of the viral DNA into the capsid.

[Central venous catheter-related infections in critically ill patients].

PubMed

Diener, J R; Coutinho, M S; Zoccoli, C M

1996-01-01

To determine incidence rate, etiology and risk factors for central venous catheter (CVC)-related infections in critically-ill patients, a prospective cohort study was conducted in the general Intensive Care Unit (ICU) of a 212 bed Hospital in Florianópolis, Brazil. Patients admitted to ICU between May 1993 and February 1994, exposed to short-term CVC, were included in the study. Quantitative skin culture at CVC insertion site, semi-quantitative CVC tip culture, quantitative hub culture, and peripheral blood-culture were done. Results were submitted to univariate and multivariate analysis. Fifty-seven catheterization periods were analysed in 51 patients. The incidence rate was 21.1% (33.1 per 1,000 catheter-days) for local infection, and 8.7% (14.1 per 1,000 catheter-days) for catheter-associated bacteremia. The skin at the insertion site was colonized in 32.7% and the hub in 29.1% of the patients respectively. Potential sources of infection were the skin in 41.2% of the cases, the hub in 29.4%, remote site in 5.9% and unknown in 23.5%. The hub was implicated in 60% of the catheter-associated bacteremias. Coagulase-negative staphylococci were the main isolates. Another intravascular device and purulence at the insertion site were independently associated with local infection. Insertion at internal jugular site and hub colonization were independently associated with bacteremia. Catheter-associated bacteremia is a major complication of central venous catheterization in critically-ill patients. Internal jugular insertion and CVC hub colonization are important risk factors for significant catheter-related infections.

Evaluation of a levonorgestrel-releasing intrauterine system for treating endometrial hyperplasia in patients with polycystic ovary syndrome.

PubMed

Lin, Min; Xu, XiaoWen; Wang, Yi; Hu, Yue; Zhao, Yu

2014-01-01

To evaluate the use of a levonorgestrel-releasing intrauterine system (LNG-IUS) for treating endometrial hyperplasia in patients with polycystic ovary syndrome (PCOS). LNG-IUSs were inserted in 60 PCOS patients with simple (40 cases), irregular (12 cases), or complex (8 cases) endometrial hyperplasia. Follow-ups were performed at 3, 6, 12, and 24 months after insertion. At each time point, changes in menstruation, hemoglobin level, and endometrial thickness and pathology were recorded. Menstrual changes were assessed with the Pictorial Blood Assessment Chart. Hemoglobin levels were measured by the Blood Routine Test. Endometrial thickness was determined by transvaginal ultrasound. Endometrial pathology was defined as simple, irregular, or complex endometrial hyperplasia by a pathologist after curettage. Outcomes at each time point were compared to baseline (pre-insertion) measurements by Student's t test or ANOVA (for multiple comparisons) with the post hoc Dunnett's test. Differences with a p < 0.05 were considered statistically significant. At all time points after LNG-IUS insertion and in all patients, menstrual blood loss was decreased and hemoglobin level was increased significantly compared to pre-insertion levels. The endometrial thickness was significantly reduced in all groups after 12 months. Most patients showed transformation of the endometrial pathology, with complete disappearance of simple and irregular cases of endometrial hyperplasia and a decreased number of complex endometrial hyperplasia cases. LNG-IUS is an effective, safe, nonsurgical, and atraumatic approach with few side effects for the treatment of endometrial hyperplasia in patients with PCOS. © 2014 S. Karger AG, Basel.

A cohort evaluation of the pediatric ProSeal laryngeal mask airway in 100 children.

PubMed

Kelly, Fiona; Sale, Steven; Bayley, Guy; Cook, Tim; Stoddart, Peter; White, Michelle

2008-10-01

The ProSeal laryngeal mask airway (PLMA) has been available in pediatric sizes in the UK since 2007. Although several non-UK studies have evaluated PLMAs in children, there are little published data regarding their use in this country. Having decided to introduce the pediatric PLMA into our practice, we chose to prospectively audit the first 100 uses as part of our clinical governance. We studied children undergoing elective surgery who were considered suitable for a supraglottic airway. We recorded patient, surgical and insertion details, device performance data and complications. Patient management was not altered by inclusion in this audit. Twenty size 1.5, 55 size 2.0, 15 size 2.5 and 10 size 3.0 PLMAs were inserted in 100 consecutive children [median age 2 years (range 2 months to 10 years) and median weight 15 kg (range 4.9-60 kg)]. The overall first attempt success rate was 93% (size 1.5, 100%; size 2.0, 100%; size 2.5, 87%; size 3.0, 90%) and overall successful insertion rate was 99%. Median leak pressure was 25 cmH(2)O. Outright failure was seen in one patient; complications were seen in another six patients (partial airway obstruction in five patients and mild laryngospasm in one patient), all of whom were transient and none of whom required intubation. No episodes of regurgitation were recorded. Even without prior experience and using nonconventional insertion, pediatric PLMAs (including size 1.5) can be easily inserted and provide an effective airway.

How to improve the readability of the patient package leaflet: a survey on the use of colour, print size and layout.

PubMed

Bernardini, C; Ambrogi, V; Fardella, G; Perioli, L; Grandolini, G

2001-05-01

This paper displays the results of the second part of a survey about patient information and the use of the patient package leaflet. The aim of this research is to investigate the consumers' attitude towards written information. As the formal aspects of the written message are very important in communication, we prepared a questionnaire in order to evaluate the attitude of patients towards some typographical modifications. Patients were invited to give indications about which colours could be used in the different paragraphs of the package leaflet and which print size could be easily read. All people interviewed were asked to choose a colour, from six proposed by us, to be used for 'therapeutic indications', 'side effects', 'how to use', 'paediatric use', 'contraindications', 'use in pregnancy' and 'warnings'. Clear suggestions for the choice of colours for therapeutic indications, side effects and contraindications arose from the survey. In the other cases there was no uniformity of answers. All people complained that the print size used in the package leaflet is too small and suggested 10 and 11 points Didot. Finally, from the survey it emerged that people would appreciate a more detailed package leaflet but information should be given in a schematic and concise way. Copyright 2001 Academic Press.

Does Bedside Sonography Effectively Identify Nasogastric Tube Placements in Pediatric Critical Care Patients?

PubMed

Atalay, Yunus Oktay; Aydin, Ramazan; Ertugrul, Omer; Gul, Selim Baris; Polat, Ahmet Veysel; Paksu, Muhammet Sukru

2016-12-01

A nasogastric tube (NGT) insertion is a common procedure in intensive care units, with some serious complications that result from the malposition of the NGT tip. This pilot study was designed to investigate the efficiency of ultrasound in verifying correct NGT placement and to compare these results with radiographic findings. This was a single-center, double-blind prospective study of patients who had received an NGT in the pediatric critical care unit. Twenty-one patients aged 1 month to 18 years were included in this study. All NGTs were inserted by the same critical care physician. After insertion, the physician first confirmed NGT placement by the auscultation of the epigastrium following the insufflation of air. Confirmation was supplemented with an abdominal radiograph. A radiologist who was unaware of the radiographic findings performed bedside sonography on all patients and verified the location of the NGTs. The findings from these 2 physicians were then compared. NGTs were inserted without any complications, and none of the NGTs were positioned in the respiratory tract in any of the patients. All NGT tips were visualized by radiography and sonography with a sensitivity of 100%. Bedside sonography performed by a radiologist is an effective and sensitive diagnostic procedure for confirming the correct NGT position in patients in the pediatric critical care unit.

Effectiveness of electrocardiographic guidance in CVAD tip placement.

PubMed

Walker, Graham; Chan, Raymond J; Alexandrou, Evan; Webster, Joan; Rickard, Claire

International standard practice for the correct confirmation of the central venous access device is the chest X-ray. The intracavitary electrocardiogram-based insertion method is radiation-free, and allows real-time placement verification, providing immediate treatment and reduced requirement for post-procedural repositioning. Relevant databases were searched for prospective randomised controlled trials (RCTs) or quasi RCTs that compared the effectiveness of electrocardiogram-guided catheter tip positioning with placement using surface-anatomy-guided insertion plus chest X-ray confirmation. The primary outcome was accurate catheter tip placement. Secondary outcomes included complications, patient satisfaction and costs. Five studies involving 729 participants were included. Electrocardiogram-guided insertion was more accurate than surface anatomy guided insertion (odds ratio: 8.3; 95% confidence interval (CI) 1.38; 50.07; p=0.02). There was a lack of reporting on complications, patient satisfaction and costs. The evidence suggests that intracavitary electrocardiogram-based positioning is superior to surface-anatomy-guided positioning of central venous access devices, leading to significantly more successful placements. This technique could potentially remove the requirement for post-procedural chest X-ray, especially during peripherally inserted central catheter (PICC) line insertion.

Single- and double-balloon enteroscopy-assisted endoscopic retrograde cholangiopancreatography in patients with Roux-en-Y plus hepaticojejunostomy anastomosis and Whipple resection.

PubMed

Itokawa, Fumihide; Itoi, Takao; Ishii, Kentaro; Sofuni, Atsushi; Moriyasu, Fuminori

2014-04-01

In patients with Roux-en-Y hepaticojejunostomy (HJ with R-Y) and Whipple resection, endoscopic retrograde cholangiopancreatography (ERCP) can be challenging. We report our experience with ERCP using balloon-assisted enteroscopy (BAE) (BAE-ERCP) in patients with HJ with R-Y, and Whipple resection. BAE-ERCP procedures were carried out in 62 patients (HJ with R-Y:Whipple resection=34:28). Overall, the rates of reaching the anastomosis were 85.3% (29/34) in HJ with R-Y and 96.4% (27/28) in Whipple resection. In terms of HJ with R-Y, insertion success rate by standard single-balloon enteroscopy (SBE) was 89.3% (25/28). Insertion success rate by short BAE, including SBE and double-balloon enteroscopy (DBE), was 50% (3/6). There was a statistically significant difference of insertion success rate between standard long BE and short BE (P=0.021). However, in the Whipple patients, insertion success rate by standard and short SBE was 93.8% (15/16) and 91.7% (11/12), respectively. Initial insertion success rate by short BAE in Whipple patients was significantly higher than in HJ with R-Y (91.7% vs 50%, P=0.045). Therapeutic interventions included dilation of anastomosis stricture, stone extraction, endoscopic mechanical lithotripsy, biliary stent placement, stent extraction, endoscopic nasobiliary drainage, direct cholangioscopy, and electrohydraulic lithotripsy. Our HJ with R-Y series and Whipple series treatment success rate was 90% (18/20) and 95.0% (19/20), respectively. BAE-ERCP enabled ERCP to be carried out in patients with HJ. It is considered safe and feasible. Further experience and device improvement are needed. © 2014 The Authors. Digestive Endoscopy © 2014 Japan Gastroenterological Endoscopy Society.

Elective gastrostomy, nutritional status and quality of life in advanced head and neck cancer patients receiving chemoradiotherapy.

PubMed

Morton, Randall P; Crowder, Victoria L; Mawdsley, Robert; Ong, Esther; Izzard, Mark

2009-10-01

Chemoradiotherapy for treatment of advanced head and neck cancer (HNC) is used to achieve organ preservation without compromising survival. Because chemoradiotherapy usually impacts adversely on nutritional and functional status, feeding by percutaneous endoscopic gastrostomy (PEG) is often part of the management regimen for these patients, but the presence of a PEG tube can also be associated with reduced quality of life (QOL). This study aimed to examine the factors associated with PEG insertion and the effects of PEG use on QOL and functional outcomes in HNC patients receiving chemoradiotherapy. Survey of 36 consecutive patients treated by primary chemoradiotherapy for HNC. Patient weight, age, tumour type, details of PEG insertion, feeding regimens and treatment were noted. The survey comprised the Performance Status Scale, the Functional Measure for Swallowing, Nutritional Mode and a self-assessment of QOL. PEG insertion within 1 month of treatment was associated with smaller fall in body mass index at 12 months than PEG insertion 1 month or more after the start of the treatment (P < 0.05). Body mass index change was inversely correlated with health-related quality of life and significantly related to lower speech and swallowing function scores. Longer PEG duration correlated with poorer performance status and swallowing function (P < 0.01). Longer PEG duration also predicted poorer overall QOL (P < 0.01) and poorer swallowing (P < 0.01) and speech (P < 0.05). Nutritional mode was related to overall QOL (P < 0.01). Nutritional support for HNC patients undergoing chemoradiotherapy is an essential component of patient care. Early PEG insertion and shorter PEG duration are associated with more favourable QOL-related outcomes.

Modified C1 lateral mass screw insertion using a high entry point to avoid postoperative occipital neuralgia.

PubMed

Lee, Sun-Ho; Kim, Eun-Sang; Eoh, Whan

2013-01-01

For the past decade, a screw-rod construct has been used commonly to stabilize the atlantoaxial joint, but the insertion of the screw through the C1 lateral mass (LM) can cause several complications. We evaluated whether using a higher screw entry point for C1 lateral mass (LM) fixation than in the standard procedure could prevent screw-induced occipital neuralgia. We enrolled 12 consecutive patients who underwent bilateral C1 LM fixation, with the modified screw insertion point at the junction of the C1 posterior arch and the midpoint of the posterior inferior portion of the C1 LM. We measured postoperative clinical and radiological parameters and recorded intraoperative complications, postoperative neurological deficits and the occurrence of occipital neuralgia. Postoperative plain radiographs were used to check for malpositioning of the screw or failure of the construct. Four patients underwent atlantoaxial stabilization for a transverse ligament injury or a C1 or C2 fracture, six patients for os odontoideum, and two patients for C2 metastasis. No patient experienced vertebral artery injury or cerebrospinal fluid leak, and all had minimal blood loss. No patient suffered significant occipital neuralgia, although one patient developed mild, transient unilateral neuralgia. There was also no radiographic evidence of construct failure. Twenty screws were positioned correctly through the intended entry points, but three screws were placed inferiorly (that is, below the arch), and one screw was inserted too medially. When performing C1-C2 fixation using the standard (Harms) construct, surgeons should be aware of the possible development of occipital neuralgia. A higher entry point may prevent this complication; therefore, we recommend that the screw should be inserted into the arch of C1 if it can be accommodated. Copyright © 2012 Elsevier Ltd. All rights reserved.

A novel method for percutaneous insertion of a right ventricular assist device.

PubMed

Avgerinos, Dimitrios V; DeBois, William; Mongero, Linda; Krieger, Karl; Salemi, Arash

2013-06-01

Right heart failure is a rare but often fatal complication both in the pre- and postoperative setting. Right heart support with a ventricular assist device inserted in the operating room through median sternotomy can be a time-consuming procedure that requires a reoperation for removal. In cases of urgent need of right heart support, a percutaneous technique option may be of benefit. We present our initial experience with a percutaneously inserted right ventricular assist device (RVAD) in an elderly patient with severe right heart failure. An 81-year-old female patient underwent combined aortic and mitral valve replacement at our institution. During the first postoperative evening, the patient sustained sudden cardiovascular collapse and a bedside transesophageal echocardiogram revealed severe right heart failure. A coronary angiogram showed thrombosis of the right coronary artery, which was cleared with a suction device. As a result of the patient's critical condition, it was decided that an RVAD was needed as a bridge to recovery. The patient's condition improved significantly almost immediately. Her right heart function recovered over the next few days and the RVAD was removed at the bedside. She made a complete recovery and was discharged home. This patient is a prime example that a totally RVAD can be inserted in urgent situations easily and safely under fluoroscopic and echocardiographic guidance. More clinical experience with percutaneous RVADs is required to establish this technique as an alternative equivalent to the traditional open method. Right heart failure complicates many heart diseases both in the pre- and the postoperative setting. In cases of urgent need of right heart support, a percutaneous technique of a RVAD is needed for a successful outcome. We present our initial experience with a percutaneously inserted RVAD in an elderly patient with severe postoperative right heart failure.

Retrievable Inferior Vena Cava Filters: Indications, Indwelling Time, Removal, Success and Complication Rates.

PubMed

Tashbayev, Alisher; Belenky, Alexander; Litvin, Sergey; Knizhnik, Michael; Bachar, Gil N; Atar, Eli

2016-02-01

Various vena cava filters (VCF) are designed with the ability to be retrieved percutaneously. Yet, despite this option most of them remain in the inferior vena cava (IVC). To report our experience in the placement and retrieval of three different types of VCFs, and to compare the indications for their insertion and retrieval as reported in the literature. During a 5 year period three types of retrievable VCF (ALN, OptEase, and Celect) were inserted in 306 patients at the Rabin Medical Center (Beilinson and Hasharon hospitals). Indications, retrieval rates, median time to retrieval, success and complication rates were viewed and assessed in the three groups of filter types and were compared with the data of similar studies in the literature. Of the 306 VCFs inserted, 31 (10.1%) were retrieved with equal distribution in the three groups. In most patients the reason for filter insertion was venous thromboembolic events (VTE) and contraindications to anticoagulant therapy. Mean age was 68.38 ± 17.5 years (range 18-99) and was noted to be significantly higher compared to similar studies (53-56 years) (P < 0.0001). Multi-trauma patients were significantly older (71.11 ± 14.99 years) than post-pulmonary embolism patients (48.03 ± 20.98 years, P < 0.0001) and patients with preventive indication (26.00 ± 11.31, P < 0.0001). The mean indwelling time was 100.6 ± 103.399 days. Our results are comparable with the results of other studies, and there was no difference in percentage of retrieval or complications between patients in each of the three groups. In 1 of 10 patients filters should be removed after an average of 3.5 months. All three IVC filter types used are safe to insert and retrieve.

The reversibility of reduced cortical vein compliance in normal-pressure hydrocephalus following shunt insertion.

PubMed

Bateman, G A

2003-02-01

Superficial cortical venous compression secondary to alterations in craniospinal compliance is implicated in the pathogenesis of normal pressure hydrocephalus (NPH). A reduction in the pulsation in the outflow of the cortical veins would be expected to occur following compression of these veins and this has been shown in NPH. If cortical vein compression is a causative factor in NPH, it would be expected that cortical vein compliance as measured by pulsatility would be significantly altered by a curative procedure i.e. shunt tube insertion. My purpose is to compare the blood flow pulsatility characteristics in a group of patients with NPH before and after shunt tube insertion. I initially studied 18 subjects without pathology with MRI flow quantification studies of the cerebral arteries and veins to define the range of normality. The main study involved 18 patients with idiopathic dementia and mild leukoaraiosis who served as controls and seven patients with NPH studied before and after shunt insertion. Arterial, superior sagittal and straight sinus pulsatility was not significantly different between the patients with idiopathic dementia and those NPH patients before or after shunting. Cortical vein pulsatility before shunting in the patients with NPH was 43% lower than in those with idiopathic dementia ( P=0.006). Following shunting, cortical vein pulsatility increased by 186% ( P=0.007). There is thus reduced compliance in cortical veins in NPH which is significantly increased in patients who respond to insertion of a shunt tube. These findings suggest that reversible elevation in cortical vein pressure and reversal of the normal absorption pathway for cerebrospinal fluid may be behind the pathophysiology of NPH.

Incidence of upper limb venous thrombosis associated with peripherally inserted central catheters (PICC).

PubMed

Abdullah, B J J; Mohammad, N; Sangkar, J V; Abd Aziz, Y F; Gan, G G; Goh, K Y; Benedict, I

2005-07-01

The objective of this study was to prospectively determine the incidence of venous thrombosis (VT) in the upper limbs in patients with peripherally inserted central catheters (PICC). We prospectively investigated the incidence of VT in the upper limbs of 26 patients who had PICC inserted. The inclusion criteria were all patients who had a PICC inserted, whilst the exclusion criterion was the inability to perform a venogram (allergies, previous contrast medium reaction and inability of gaining venous access). Both valved and non-valved catheters were evaluated. Prior to removal of the PICC, an upper limb venogram was performed. The number of segments involved with VT were determined. The duration of central venous catheterization was classified as; less than 6 days, between 6 days and 14 days and more than 14 days. VT was confirmed in 38.5% (10/26) of the patients. The majority 85.7% (12/14) were complete occlusive thrombi and the majority of VT only involved one segment. There was no statistical correlation between the site of insertion of the PICC and the location of VT. Neither was there any observed correlation between the occurrence of VT with the patient's history of hypertension, hypercholesterolaemia, coronary artery disease, diabetes mellitus, cardiac insufficiency, smoking or cancer. There was also no statistical correlation with the size of the catheter. In conclusion, PICCs are associated with a significant risk of upper extremity deep vein thrombosis (UEVT).

Evaluation of a microarray-based genotyping assay for the rapid detection of cytochrome P450 2C19 *2 and *3 polymorphisms from whole blood using nanoparticle probes.

PubMed

Buchan, Blake W; Peterson, Jess F; Cogbill, Christopher H; Anderson, Dennis K; Ledford, Joellen S; White, Mary N; Quigley, Neil B; Jannetto, Paul J; Ledeboer, Nathan A

2011-10-01

Numerous drugs such as clopidogrel have been developed to reduce coagulation or inhibit platelet function. The hepatic cytochrome P450 (CYP) pathway is involved in the conversion of clopidogrel to its active metabolite. A recent black-box warning was included in the clopidogrel package insert indicating a significant clinical link between specific CYP2C19 genetic variants and poor metabolism of clopidogrel. Of these variants, *2 and *3 are the most common and are associated with complete loss of enzyme activity. In patients who are carriers of a CYP2C19 *2 or *3 allele, the conversion of clopidogrel to its active metabolite may be reduced, which can lead to ischemic events and negative consequence for the patient. We examined the ability of the Verigene CLO assay (Nanosphere, Northbrook, IL) to identify CYP2C19 *2 and *3 polymorphisms in 1,286 unique whole blood samples. The Verigene CLO assay accurately identified homozygous and heterozygous *2 and *3 phenotypes with a specificity of 100% and a final call rate of 99.7%. The assay is fully automated and can produce a result in approximately 3.5 hours.

Diagnosis of Exclusion: A Case Report of Probable Glatiramer Acetate-Induced Eosinophilic Myocarditis

PubMed Central

Michaud, Christopher J.; Bockheim, Heather M.; Daum, Timothy E.

2014-01-01

Importance. Medication-induced eosinophilia is an acknowledged, often self-limiting occurrence. Glatiramer acetate, a biologic injection used in the management of relapsing-remitting multiple sclerosis, is widely regarded as a safe and effective medication and lists eosinophilia as an infrequent side effect in its package insert. Contrary to reports of transient, benign drug-induced eosinophilia, we describe a case of probable glatiramer acetate-induced eosinophilia that ultimately culminated in respiratory distress, shock, and eosinophilic myocarditis. Observations. A 59-year-old female was admitted to the hospital after routine outpatient labs revealed leukocytosis (43,000 cells/mm3) with pronounced hypereosinophilia (63%). This patient had been using glatiramer acetate without complication for over 10 years prior to admission. Leukocytosis and hypereosinophilia persisted as a myriad of diagnostic evaluations returned negative, ultimately leading to respiratory depression, shock, and myocarditis. Glatiramer acetate was held for the first time on day 6 of the hospital stay with subsequent resolution of leukocytosis, hypereosinophilia, respiratory distress, and shock. Conclusions and Relevance. Glatiramer acetate was probably the cause of this observed hypereosinophilia and the resulting complications. Reports of glatiramer-induced eosinophilia are rare, and few case reports regarding medication-induced hypereosinophilia describe the severe systemic manifestations seen in this patient. PMID:25105037

Diagnosis of exclusion: a case report of probable glatiramer acetate-induced eosinophilic myocarditis.

PubMed

Michaud, Christopher J; Bockheim, Heather M; Nabeel, Muhammad; Daum, Timothy E

2014-01-01

Importance. Medication-induced eosinophilia is an acknowledged, often self-limiting occurrence. Glatiramer acetate, a biologic injection used in the management of relapsing-remitting multiple sclerosis, is widely regarded as a safe and effective medication and lists eosinophilia as an infrequent side effect in its package insert. Contrary to reports of transient, benign drug-induced eosinophilia, we describe a case of probable glatiramer acetate-induced eosinophilia that ultimately culminated in respiratory distress, shock, and eosinophilic myocarditis. Observations. A 59-year-old female was admitted to the hospital after routine outpatient labs revealed leukocytosis (43,000 cells/mm(3)) with pronounced hypereosinophilia (63%). This patient had been using glatiramer acetate without complication for over 10 years prior to admission. Leukocytosis and hypereosinophilia persisted as a myriad of diagnostic evaluations returned negative, ultimately leading to respiratory depression, shock, and myocarditis. Glatiramer acetate was held for the first time on day 6 of the hospital stay with subsequent resolution of leukocytosis, hypereosinophilia, respiratory distress, and shock. Conclusions and Relevance. Glatiramer acetate was probably the cause of this observed hypereosinophilia and the resulting complications. Reports of glatiramer-induced eosinophilia are rare, and few case reports regarding medication-induced hypereosinophilia describe the severe systemic manifestations seen in this patient.

Association of the insertion allele of the common ACE gene polymorphism with type 2 diabetes mellitus among Kuwaiti cardiovascular disease patients.

PubMed

Al-Serri, Ahmad; Ismael, Fatma G; Al-Bustan, Suzanne A; Al-Rashdan, Ibrahim

2015-12-01

The D allele of the common angiotensin-converting enzyme (ACE) I/D gene polymorphism (rs4646994) predisposes to type 2 diabetes mellitus (T2DM) and cardiovascular disease (CVD). However, results on which allele predisposes to disease susceptibility remain controversial in Asian populations. This study was performed to evaluate the association of the common ACE I/D gene polymorphism with both T2DM and CVD susceptibility in an Arab population. We genotyped the ACE I/D polymorphisms by direct allele-specific PCR in 183 healthy controls and 400 CVD patients with diabetes (n=204) and without (n=196). Statistical analysis comparing between the different groups were conducted using R statistic package "SNPassoc". Two genetic models were used: the additive and co-dominant models. The I allele was found to be associated with T2DM (OR=1.84, p=0.00009) after adjusting for age, sex and body mass index. However, there was no association with CVD susceptibility (p>0.05). The ACE I allele is found to be associated with T2DM; however, no association was observed with CVD. The inconsistency between studies is suggested to be attributed to genetic diversity due to the existence of sub-populations found in Asian populations. © The Author(s) 2015.

Transfemoral transcatheter aortic valve insertion-related intraoperative morbidity: Implications of the minimalist approach.

PubMed

Greason, Kevin L; Pochettino, Alberto; Sandhu, Gurpreet S; King, Katherine S; Holmes, David R

2016-04-01

Transfemoral transcatheter aortic valve insertion may be performed in a catheterization laboratory (ie, the minimalist approach). It seems reasonable when considering this approach to avoid it in patients at risk for intraoperative morbidity that would require surgical intervention. We hypothesized that it would be possible to associate baseline characteristics with such morbidity, which would help heart teams select patients for the minimalist approach. We reviewed the records of 215 consecutive patients who underwent transfemoral transcatheter aortic valve insertion with a current commercially available device from November 2008 through July 2015. Demographic characteristics of the patients included a mean age of 78.9 ± 10.6 years, female sex in 73 patients (34.0%), and a mean Society of Thoracic Surgeons predicted risk of mortality of 8.7% ± 5.4%. Valve prostheses were balloon-expandable in 126 patients (58.6%) and self-expanding in 89 patients (41.4%). Significant intraoperative morbidity occurred in 22 patients (10.2%) and included major vascular injury in 12 patients (5.6%), hemodynamic compromise requiring cardiopulmonary bypass support in 4 patients (1.9%), cardiac tamponade requiring intervention in 3 patients (1.4%), ventricular valve embolization in 2 patients (0.9%), and inability to obtain percutaneous access requiring open vascular access in 1 patient (0.5%). Intraoperative morbidity was similarly distributed across all valve types (P = .556) and sheath sizes (P = .369). There were no baseline patient characteristics predictive of intraoperative morbidity. Patient and valve characteristics are not predictive of significant intraoperative morbidity during transfemoral transcatheter aortic valve insertion. The finding has implications for patient selection for the minimalist approach. Copyright © 2016 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

Biodegradable braided poly(lactic-co-glycolic acid) urethral stent combined with dutasteride in the treatment of acute urinary retention due to benign prostatic enlargement: a pilot study.

PubMed

Kotsar, Andres; Isotalo, Taina; Juuti, Hanne; Mikkonen, Joonas; Leppiniemi, Jenni; Hänninen, Venla; Kellomäki, Minna; Talja, Martti; Tammela, Teuvo L J

2009-03-01

To evaluate, in a pilot study, the efficacy and safety of combining a braided poly(lactic-co-glycolic acid) (PLGA, a copolymer of l-lactide and glycolide) urethral stent and dutasteride in the treatment of acute urinary retention (AUR) due to benign prostatic enlargement (BPE). Ten men with AUR due to BPE were treated as outpatients. A biodegradable braided PLGA urethral stent was inserted into the prostatic urethra, using a specially designed insertion device under visual control. Dutasteride treatment was started and the patients were followed up for 3 months after insertion of the stents. In all patients the stents were placed successfully with the new insertion device. All men were able to void after inserting the stent. At 1 month five patients voided freely with a low residual urine volume (<150 mL), two voided but had a high residual urine volume and a suprapubic catheter was placed, and three needed a suprapubic or an indwelling catheter before 1 month, due to AUR or comorbidities. At 3 months five patients were voiding with no problems. We have developed a new and effective insertion device for biodegradable braided prostatic stents. The new braided-pattern stent overcomes the earlier problems of migration and sudden breakage into large particles associated with biodegradable spiral stents. However, the mechanical properties of the new stent need to be improved and tested in a longer follow-up. We consider that this new biodegradable braided-pattern urethral stent could provide a new option in the future treatment of AUR.

Octenidine hydrochloride for the care of central venous catheter insertion sites in severely immunocompromised patients.

PubMed

Tietz, Andreas; Frei, Reno; Dangel, Marc; Bolliger, Dora; Passweg, Jakob R; Gratwohl, Alois; Widmer, Andreas E

2005-08-01

To determine the efficacy and tolerability of octenidine hydrochloride, a non-alcoholic skin antiseptic, for the care of central venous catheter (CVC) insertion sites. Prospective, observational study. Bone marrow transplantation unit of a university hospital. All consecutive patients with a nontunneled CVC were enrolled prospectively after informed consent. Octenidine hydrochloride (0.1%) was applied for disinfection at the CVC insertion site during dressing changes. The following cultures were performed weekly as well as at the occurrence of any systemic inflammatory response syndrome criteria: cultures of the skin surrounding the CVC entry site, cultures of the three-way hub connected to the CVC, blood cultures, and cultures of the CVC tip on removal. Enhanced microbiological methods (skin swabs of a 24-cm2 standardized area, roll plate, and sonication of catheter tips) were applied. One hundred thirty-five CVCs were inserted in 62 patients during the study period and remained for a mean period of 19.1 days, corresponding to 2,462 catheter-days. Bacterial density at the insertion site declined substantially over time, and most cultures became negative 2 weeks after insertion. Only 6 patients had a documented catheter-related bloodstream infection. The incidence density was 2.39 catheter infections per 1,000 catheter-days. No side effects were noted with application of the antiseptic. Disinfection with a skin antiseptic that contains octenidine hydrochloride is highly active and well tolerated. It leads to a decrease in skin colonization over time and may be a new option for CVC care.

Combination therapy for male erectile dysfunction and urinary incontinence.

PubMed

Zafirakis, Helen; Wang, Run; Westney, O Lenaine

2008-01-01

Urinary incontinence (UI) and erectile dysfunction (ED) are both very prevalent conditions. Insertion of an artificial urinary sphincter (AUS) and penile prosthesis (PP) is an effective and proven method of treatment for both conditions. With advancing age, as well as with increasing populations of patients radically treated for prostate cancer, the occurrence of both conditions found in the same patient is increasing. The purpose of this article was to analyze the available evidence for simultaneous surgical management of male ED and UI using prosthetic devices. The existing literature pertaining to dual implantation of AUS and PP was reviewed. The concomitant insertion of the PP with the male perineal sling was also considered. Concurrent ED and UI are increasingly seen in the post radical prostatectomy population, who are often younger and less willing to suffer with these conditions. Insertion of an AUS and PP, either simultaneously or as a two-stage procedure, appears to be a safe, efficacious and long-lasting method of treatment. The improvements in design of both the AUS and PP as well as the development of the single transverse scrotal incision have made simultaneous insertion of these prostheses possible. Dual implantation of the PP and male sling looks promising in a selected population. In conclusion, the insertion of the AUS and PP for the treatment of concurrent UI and ED is safe and effective. Simultaneous insertion of these prostheses in the same patient offers potential advantages in operative and recovery time and is associated with high patient satisfaction. Combination therapy should therefore be included in the arsenal of treatment of these conditions.

Male patients require higher optimal effect-site concentrations of propofol during i-gel insertion with dexmedetomidine 0.5 μg/kg.

PubMed

Choi, Jung Ju; Kim, Ji Young; Lee, Dongchul; Chang, Young Jin; Cho, Noo Ree; Kwak, Hyun Jeong

2016-03-22

The pharmacokinetics and pharmacodynamics of an anesthetic drug may be influenced by gender. The purpose of this study was to compare effect-site half maximal effective concentrations (EC50) of propofol in male and female patients during i-gel insertion with dexmedetomidine 0.5 μg/kg without muscle relaxants. Forty patients, aged 20-46 years of ASA physical status I or II, were allocated to one of two groups by gender (20 patients per group). After the infusion of dexmedetomidine 0.5 μg/kg over 2 min, anesthesia was induced with a pre-determined effect-site concentration of propofol by target controlled infusion. Effect-site EC50 values of propofol for successful i-gel insertion were determined using the modified Dixon's up-and-down method. Mean effect-site EC50 ± SD of propofol for successful i-gel insertion was significantly higher for men than women (5.46 ± 0.26 μg/ml vs. 3.82 ± 0.34 μg/ml, p < 0.01). The EC50 of propofol in men was approximately 40% higher than in women. Using isotonic regression with a bootstrapping approach, the estimated EC50 (95% confidence interval) of propofol was also higher in men [5.32 (4.45-6.20) μg/ml vs. 3.75 (3.05-4.43) μg/ml]. The estimated EC95 (95% confidence interval) of propofol in men and women were 5.93 (4.72-6.88) μg/ml and 4.52 (3.02-5.70) μg/ml, respectively. During i-gel insertion with dexmedetomidine 0.5 μg/kg without muscle relaxant, male patients had higher effect-site EC50 for propofol using Schnider's model. Based on the results of this study, patient gender should be considered when determining the optimal dose of propofol during supraglottic airway insertion. ClinicalTrials.gov identifier: NCT02268656. Registered August 26, 2014.

A randomized, crossover comparison of injected buffered lidocaine, lidocaine cream, and no analgesia for peripheral intravenous cannula insertion.

PubMed

McNaughton, Candace; Zhou, Chuan; Robert, Linda; Storrow, Alan; Kennedy, Robert

2009-08-01

We compare pain and anxiety associated with peripheral intravenous (IV) cannula insertion after pretreatment with no local anesthesia, 4% lidocaine cream, or subcutaneously injected, buffered 1% lidocaine. In a randomized, crossover design, 3 peripheral IVs were inserted in each of 70 medical students or nurses. In random order, insertion sites were pretreated with nothing, lidocaine cream, or injected, buffered lidocaine. After each IV insertion, subjects recorded pain, anxiety, and preference (as patient and provider) for each technique on a 10-point numeric rating scale. Higher scores indicated greater pain, anxiety, and preference. Median pain scores (interquartile range [IQR]) were 7 (4 to 8) without local anesthesia, 3 (2 to 5) with lidocaine cream, and 1 (1 to 2) with injected, buffered lidocaine. Median anxiety scores (IQR) were 4 (2 to 7) without local anesthesia, 2 (1 to 4) with lidocaine cream, and 2 (1 to 3) with injected, buffered lidocaine. There was no detectable difference in anxiety scores between lidocaine cream and injected, buffered lidocaine. Most IV placement attempts were successful, regardless of technique. Seventy percent of subjects indicated they would "always" request buffered lidocaine for peripheral IV insertion. In adult health care providers, pain and anxiety associated with peripheral IV insertion is significantly reduced by using topical lidocaine cream or injected, buffered lidocaine. Injected, buffered lidocaine reduces IV insertion pain more than lidocaine cream, without affecting success. Adults desire the use of local anesthetic techniques for IV insertion for themselves and for their patients.

A novel adaptive needle insertion sequencing for robotic, single needle MR-guided high-dose-rate prostate brachytherapy

NASA Astrophysics Data System (ADS)

Borot de Battisti, M.; de Senneville, B. Denis; Hautvast, G.; Binnekamp, D.; Lagendijk, J. J. W.; Maenhout, M.; Moerland, M. A.

2017-05-01

MR-guided high-dose-rate (HDR) brachytherapy has gained increasing interest as a treatment for patients with localized prostate cancer because of the superior value of MRI for tumor and surrounding tissues localization. To enable needle insertion into the prostate with the patient in the MR bore, a single needle MR-compatible robotic system involving needle-by-needle dose delivery has been developed at our institution. Throughout the intervention, dose delivery may be impaired by: (1) sub-optimal needle positioning caused by e.g. needle bending, (2) intra-operative internal organ motion such as prostate rotations or swelling, or intra-procedural rectum or bladder filling. This may result in failure to reach clinical constraints. To assess the first aforementioned challenge, a recent study from our research group demonstrated that the deposited dose may be greatly improved by real-time adaptive planning with feedback on the actual needle positioning. However, the needle insertion sequence is left to the doctor and therefore, this may result in sub-optimal dose delivery. In this manuscript, a new method is proposed to determine and update automatically the needle insertion sequence. This strategy is based on the determination of the most sensitive needle track. The sensitivity of a needle track is defined as its impact on the dose distribution in case of sub-optimal positioning. A stochastic criterion is thus presented to determine each needle track sensitivity based on needle insertion simulations. To assess the proposed sequencing strategy, HDR prostate brachytherapy was simulated on 11 patients with varying number of needle insertions. Sub-optimal needle positioning was simulated at each insertion (modeled by typical random angulation errors). In 91% of the scenarios, the dose distribution improved when the needle was inserted into the most compared to the least sensitive needle track. The computation time for sequencing was less than 6 s per needle track. The proposed needle insertion sequencing can therefore assist in delivering an optimal dose in HDR prostate brachytherapy.

Indications, retrieval rate, and complications of inferior vena cava filters: Single-center experience in Saudi Arabia.

PubMed

Shabib, Abdullah Bin; Alsayed, Fahad; Aldughaythir, Saad; Habeeb, Hanan; Al Tamimi, Sumayyah; Masuadi, Emad; Alzahrani, Mohsen; Alaklabi, Ali; Alotaibi, Azzam; Rajendram, Rajkumar; Almegren, Mosaad

2018-01-01

Inferior vena cava (IVC) filter is indicated in patients with acute venous thromboembolism (VTE) in whom therapeutic anticoagulation is contraindicated. While prophylactic insertion of an IVC filter may be considered for patients at high risk of VTE, there are significant differences between clinical guidelines on the role of IVC filters. These discrepancies have arisen predominantly because of the paucity of data on the efficacy and safety of IVC filters. We, therefore, evaluated the indications for filter insertion, the rate of filter retrieval and complications in patients who received IVC filters at King Abdulaziz Medical City (KAMC), Riyadh, Saudi Arabia. A descriptive, retrospective review of electronic- and paper-based medical records was performed. Consecutive sampling was used to study all adult patients who received an IVC filter at KAMC between 2007 and 2016 and met the inclusion criteria. A total of 382 IVC filters were inserted. 113 patients (30%) had an acute VTE and a contraindication to anticoagulation while 53 patients (14%) received an IVC filter in the absence of VTE (i.e., prophylactic). Only 124 (32.5%) IVC filters were eventually retrieved. The most common reason for nonretrieval was the need for permanent filtration (155, 60%). Thrombotic complications developed in 72 (19%) patients; nine patients had fatal pulmonary embolism. The insertion of IVC filters in this cohort was associated with low retrieval rate and relatively high incidence of thrombotic complications. Follow-up of patients is required to detect IVC filter-related complications and to increase retrieval rate.

Packaging and Labeling of Pharmaceutical Products Obtained from the Internet

PubMed Central

2011-01-01

Background For patients, the prescription container label may be the only source of instructions on how to take their medicines. In the United States, the legal requirements for a prescription label are set by federal law and state statutes. The container should be comparable to that which manufacturers use to package drug products and should preserve a product’s identity, strength, quality, and purity and prevent contamination. Safety features such as a child-resistant closure should be provided. Pharmaceutical products purchased from international online pharmacies are not approved by the Food and Drug Administration (FDA) and may not meet US guidelines for labeling and packaging. Objective The study objective was to determine whether commonly purchased pharmaceutical products obtained from international online pharmacies are comparable to products dispensed in the United States with regard to labeling and packaging. Methods During March 2006 through January 2007, 41 pharmaceutical oral dosage form samples were obtained from international Internet pharmacy websites for evaluation: 18 generic simvastatin samples, 18 generic amlodipine samples, and 5 generic sildenafil samples. Contents for each package were observed and recorded and comparison of the prescription labeling and packaging of these products was made with prescription labeling and packaging requirements in the United States. Results Of the 41 drug products obtained from online pharmacies from 12 different countries, only 1 product (from Canada) would meet both labeling and packaging guidelines for products dispensed in the United States. Of those not meeting the requirements, 7 were dispensed in paper envelopes with label affixed that was either handwritten or typed and contained missing information such as name and address of dispenser, name of prescriber, name of patient, and directions for use. Another 3 products did not have a label affixed to the drug product, but information was printed on a paper document enclosed in the shipping package, while 28 products did not have labels affixed to the drug product. In all, 39 of the 41 drug products’ packaging would not meet the US guidelines. Aside from the Canadian product, only 1 product from Mexico was dispensed in a container that would meet guidelines established in the United States. In total, 35 products were not dispensed in plastic vials but were dispensed in unit dose packages, paper envelopes with loose dosage forms, blister packs of drugs held together with rubber bands, or a combination of these packaging forms. Conclusions Results suggest that labeling and packaging standards for international generic drug products are not equivalent to labeling and packaging standards in the United States. This suggests dissimilar and substandard distribution processes compared with those in the United States, which in turn presents a challenge to patient comprehension and health literacy and may affect patient adherence to drug treatment regimens. These findings have strong implications for drug product quality, patient outcomes, therapeutic effectiveness, and safety. PMID:21324833

Packaging and labeling of pharmaceutical products obtained from the internet.

PubMed

Veronin, Michael

2011-02-15

For patients, the prescription container label may be the only source of instructions on how to take their medicines. In the United States, the legal requirements for a prescription label are set by federal law and state statutes. The container should be comparable to that which manufacturers use to package drug products and should preserve a product's identity, strength, quality, and purity and prevent contamination. Safety features such as a child-resistant closure should be provided. Pharmaceutical products purchased from international online pharmacies are not approved by the Food and Drug Administration (FDA) and may not meet US guidelines for labeling and packaging. The study objective was to determine whether commonly purchased pharmaceutical products obtained from international online pharmacies are comparable to products dispensed in the United States with regard to labeling and packaging. During March 2006 through January 2007, 41 pharmaceutical oral dosage form samples were obtained from international Internet pharmacy websites for evaluation: 18 generic simvastatin samples, 18 generic amlodipine samples, and 5 generic sildenafil samples. Contents for each package were observed and recorded and comparison of the prescription labeling and packaging of these products was made with prescription labeling and packaging requirements in the United States. Of the 41 drug products obtained from online pharmacies from 12 different countries, only 1 product (from Canada) would meet both labeling and packaging guidelines for products dispensed in the United States. Of those not meeting the requirements, 7 were dispensed in paper envelopes with label affixed that was either handwritten or typed and contained missing information such as name and address of dispenser, name of prescriber, name of patient, and directions for use. Another 3 products did not have a label affixed to the drug product, but information was printed on a paper document enclosed in the shipping package, while 28 products did not have labels affixed to the drug product. In all, 39 of the 41 drug products' packaging would not meet the US guidelines. Aside from the Canadian product, only 1 product from Mexico was dispensed in a container that would meet guidelines established in the United States. In total, 35 products were not dispensed in plastic vials but were dispensed in unit dose packages, paper envelopes with loose dosage forms, blister packs of drugs held together with rubber bands, or a combination of these packaging forms. Results suggest that labeling and packaging standards for international generic drug products are not equivalent to labeling and packaging standards in the United States. This suggests dissimilar and substandard distribution processes compared with those in the United States, which in turn presents a challenge to patient comprehension and health literacy and may affect patient adherence to drug treatment regimens. These findings have strong implications for drug product quality, patient outcomes, therapeutic effectiveness, and safety.

Scala vestibuli insertion in cochlear implantation: a valuable alternative for cases with obstructed scala tympani.

PubMed

Kiefer, J; Weber, A; Pfennigdorff, T; von Ilberg, C

2000-01-01

Insertion of a sufficient number of electrodes is important for a successful use of cochlear implants. We investigated the results of scala vestibuli insertion for cochlear implantation in cases of obstructed scala tympani. In a series of 200 cochlear implantations, scala vestibuli insertion was successfully performed in 4 cases with obstruction of the scala tympani. Etiologies included a temporal bone fracture, severe otosclerosis and malformations of the cochlea. The maximum insertion depth obtained via the scala vestibuli was 30 mm. Postoperative results were comparable to patients in whom conventional scala tympani insertion was performed. No adverse effects related to the site of insertion were observed. Scala vestibuli insertion offers a valuable alternative in cases of obstructed scala tympani that can be employed for a variety of etiologies. Copyright 2000 S. Karger AG, Basel

A cost analysis of approved antiretroviral strategies in persons with advanced human immunodeficiency virus disease and zidovudine intolerance.

PubMed

Bozzette, S A; Parker, R; Hay, J

1994-04-01

Treatment with zidovudine has been standard therapy for patients with advanced HIV infection, but intolerance is common. Previously, management of intolerance has consisted of symptomatic therapy, dose interruption/discontinuation, and, when appropriate, transfusion. The availability of new antiretroviral agents such as didanosine as well as adjunctive recombinant hematopoietic growth factors makes additional strategies possible for the zidovudine-intolerant patient. Because all of these agents are costly, we evaluated the cost implications of these various strategies for the management of zidovudine-intolerant individuals within a population of persons with advanced HIV disease. We performed a decision analysis using iterative algorithmic models of 1 year of antiretroviral care under various strategies. The real costs providing antiretroviral therapy were estimated by deflating medical center charges by specific Medi-Cal (Medicaid) charge-to-payment ratios. Clinical data were extracted from the medical literature, product package inserts, investigator updates, and personal communications. Sensitivity analysis was used to test the effect of error in the estimation of parameters. The models predict that a strategy of dose interruption and transfusion for zidovudine intolerance will provide an average of 46 weeks of therapy per year to the average patient at a cost of $5,555/year of therapy provided (1991 U.S. dollars). The models predict that a strategy of adding hematopoietic growth factors to the regimen of appropriate patients would increase the average amount of therapy provided to the average patient by 3 weeks (6%) and the costs attributable to therapy by 77% to $9,805/year of therapy provided.(ABSTRACT TRUNCATED AT 250 WORDS)

A comparison of buffered lidocaine versus ELA-Max before peripheral intravenous catheter insertions in children.

PubMed

Luhmann, Janet; Hurt, Sarah; Shootman, Mario; Kennedy, Robert

2004-03-01

Peripheral intravenous catheter (PIV) insertion is a common, painful experience for many children in the pediatric emergency department. Although local anesthetics such as injected buffered lidocaine have been shown to be effective at reducing pain and anxiety associated with PIV insertion, they are not routinely used. ELA-Max, a topical local anesthetic, has the advantage of needle-free administration but has not been compared with buffered lidocaine for PIV insertion. To compare the reduction of pain and anxiety during PIV insertion provided by subcutaneous buffered 1% lidocaine or topical ELA-Max in children. A randomized trial in children 4 to 17 years old undergoing PIV insertion with 22-gauge catheters was conducted. Children received either buffered lidocaine or ELA-Max. Buffered lidocaine was administered by using 30-gauge needles to inject 0.1 to 0.2 mL subcutaneously just before PIV insertion. ELA-Max was applied to the skin and occluded with Tegaderm 30 minutes before PIV insertion. Self-reported Visual Analog Scale (VAS) questionnaires (rating on a scale of 1-10; 1 = no pain, anxiety) were completed by patients and their parents before PIV insertion to assess baseline perceptions about pain and anxiety associated with PIV insertion and immediately after PIV insertion to assess pain and anxiety associated with the experience. After PIV insertion, the nurse who inserted the PIV also completed a VAS questionnaire assessing technical difficulty and satisfaction with the local anesthesia. A blinded observer also completed a VAS questionnaire to assess pain and anxiety associated with the PIV insertion. Data were analyzed by using chi2 and t tests. Sixty-nine subjects were enrolled, and questionnaires were competed by all (mean age: 12.1 +/- 4.5 years; 61% female). There were no differences for buffered lidocaine and ELA-Max groups in age, gender, race, prior IV experience, or baseline pain and anxiety. There were no significant differences between buffered lidocaine and ELA-Max in mean pain and anxiety after PIV insertion by patient, parent, and blinded observer ratings. Nurse ratings of technical difficulty, number of PIV-insertion attempts, and satisfaction with local anesthesia also were not significantly different for buffered lidocaine and ELA-Max groups. ELA-Max provided similar pain and anxiety reduction during PIV insertion in children compared with injected buffered lidocaine. Technical difficulty and satisfaction by nurses inserting the PIV also were similar.

Correlation between extension-block K-wire insertion angle and postoperative extension loss in mallet finger fracture.

PubMed

Lee, S K; Kim, Y H; Moon, K H; Choy, W S

2018-02-01

Extension-block pinning represents a simple and reliable surgical technique. Although this procedure is commonly performed successfully, some patients develop postoperative extension loss. To date, the relationship between extension-block Kirschner wire (K-wire) insertion angle and postoperative extension loss in mallet finger fracture remains unclear. We aimed to clarify this relationship and further evaluate how various operative and non-operative factors affect postoperative extension loss after extension-block pinning for mallet finger fracture. A retrospective study was conducted to investigate a relationship between extension block K-wire insertion angle and postoperative extension loss. The inclusion criteria were: (1) a dorsal intra-articular fracture fragment involving 30% of the base of the distal phalanx with or without volar subluxation of the distal phalanx; and (2) <3 weeks delay from the injury without treatment. Extension-block K-wire insertion angle and fixation angle of the distal interphalangeal (DIP) joint were assessed using lateral radiograph at immediate postoperative time. Postoperative extension loss was assessed by using lateral radiograph at latest follow-up. Extension-block K-wire insertion angle was defined as the acute angle between extension block K-wire and longitudinal axis of middle phalangeal head. DIP joint fixation angle was defined as the acute angle between the distal phalanx and middle phalanx longitudinal axes. Seventy-five patients were included. The correlation analysis revealed that extension-block K-wire insertion angle had a negative correlation with postoperative extension loss, whereas fracture size and time to operation had a positive correlation (correlation coefficient for extension block K-wire angle: -0.66, facture size: +0.67, time to operation: +0.60). When stratifying patients in terms of negative and positive fixation angle of the DIP joint, the independent t-test showed that mean postoperative extension loss is -3.67° and +4.54° (DIP joint fixation angles of <0° and ≥0°, respectively, P=0.024). When stratifying patients in terms of extension-block K-wire insertion angle (30°, 30°-40°, >40°), ANOVA showed significantly less postoperative extension loss for higher insertion angles (>40°) than for medium insertion angles (30°-40°). Mean postoperative extension loss difference between higher insertion angle (>40°) and medium insertion angle (30°-40°) was 11° (P=0.002). Using an insertion angle of the extension-block K-wire of 40°-45° and a slightly hyperextended position of the DIP joint may help reducing postoperative extension loss. Therapeutic level III. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

Effectiveness of Various Methods of Teaching Proper Inhaler Technique.

PubMed

Axtell, Samantha; Haines, Seena; Fairclough, Jamie

2017-04-01

To compare the effectiveness of 4 different instructional interventions in training proper inhaler technique. Randomized, noncrossover trial. Health fair and indigent clinic. Inhaler-naive adult volunteers who spoke and read English. Subjects were assigned to complete the following: (1) read a metered dose inhaler (MDI) package insert pamphlet, (2) watch a Centers for Disease Control and Prevention (CDC) video demonstrating MDI technique, (3) watch a YouTube video demonstrating MDI technique, or (4) receive direct instruction of MDI technique from a pharmacist. Inhaler use competency (completion of all 7 prespecified critical steps). Of the 72 subjects, 21 (29.2%) demonstrated competent inhaler technique. A statistically significant difference between pharmacist direct instruction and the remaining interventions, both combined ( P < .0001) and individually ( P ≤ .03), was evident. No statistically significant difference was detected among the remaining 3 intervention groups. Critical steps most frequently omitted or improperly performed were exhaling before inhalation and holding of breath after inhalation. A 2-minute pharmacist counseling session is more effective than other interventions in successfully educating patients on proper inhaler technique. Pharmacists can play a pivotal role in reducing the implications of improper inhaler use.

Body pushing, prescription drugs and hospital admission.

PubMed

Byard, Roger W; Kenneally, Michaela

2017-09-01

A 39-year-old man died of multi-organ failure complicating mixed drug toxicity that included methadone, oxazepam, oxycodone and nitrazepam. His past medical history involved alcohol and poly-substance abuse with chronic self-harm and suicidal ideation. There had been multiple hospital admissions for drug overdoses. At autopsy the most unusual finding was of two packages of 10 tablets each, wrapped in thin plastic film within the rectum. The insertion of drugs into body orifices and cavities has been termed body pushing to distinguish it from body packing where illicit drugs are wrapped and swallowed for transport and smuggling, and body stuffing where small amounts of loosely wrapped or unwrapped drugs are swallowed to conceal evidence from police. This case demonstrates that body pushing may not always involve illicit drugs or attempted concealment from police or customs officials. It appears that the drugs had been hidden to ensure an additional supply during the time of residence in hospital. The extent to which body pushing is currently being used by patients to smuggle drugs into secure medical facilities is yet to be determined.

Our prescription drugs kill us in large numbers.

PubMed

Gøtzsche, Peter C

2014-01-01

Our prescription drugs are the third leading cause of death after heart disease and cancer in the United States and Europe. Around half of those who die have taken their drugs correctly; the other half die because of errors, such as too high a dose or use of a drug despite contraindications. Our drug agencies are not particularly helpful, as they rely on fake fixes, which are a long list of warnings, precautions, and contraindications for each drug, although they know that no doctor can possibly master all of these. Major reasons for the many drug deaths are impotent drug regulation, widespread crime that includes corruption of the scientific evidence about drugs and bribery of doctors, and lies in drug marketing, which is as harmful as tobacco marketing and, therefore, should be banned. We should take far fewer drugs, and patients should carefully study the package inserts of the drugs their doctors prescribe for them and independent information sources about drugs such as Cochrane reviews, which will make it easier for them to say "no thanks".

[Cochlear implantation through the middle fossa approach].

PubMed

Szyfter, W; Colletti, V; Pruszewicz, A; Kopeć, T; Szymiec, E; Kawczyński, M; Karlik, M

2001-01-01

The inner part of cochlear implant is inserted into inner ear during surgery through mastoid and middle ear. It is a classical method, used in the majority cochlear centers in the world. This is not a suitable method in case of chronic otitis media and middle ear malformation. In these cases Colletti proposed the middle fossa approach and cochlear implant insertion omitting middle ear structures. In patient with bilateral chronic otitis media underwent a few ears operations without obtaining dry postoperative cavity. Cochlear implantation through the middle fossa approach was performed in this patient. The bone fenster was cut, temporal lobe was bent and petrosus pyramid upper surface was exposed. When the superficial petrosal greater nerve, facial nerve and arcuate eminence were localised, the cochlear was open in the basal turn and electrode were inserted. The patient achieves good results in the postoperative speech rehabilitation. It confirmed Colletti tesis that deeper electrode insertion in the cochlear implantation through the middle fossa approach enable use of low and middle frequencies, which are very important in speech understanding.

Identification of a novel mutation in the human growth hormone receptor gene (GHR) in a patient with Laron syndrome.

PubMed

Gennero, Isabelle; Edouard, Thomas; Rashad, Mona; Bieth, Eric; Conte-Aurio, Françoise; Marin, Françoise; Tauber, Maithé; Salles, Jean Pierre; El Kholy, Mohamed

2007-07-01

Deletions and mutations in the growth hormone receptor (GHR) gene are the underlying etiology of Laron syndrome (LS) or growth hormone (GH) insensitivity syndrome (GHIS), an autosomal recessive disease. Most patients are distributed in or originate from Mediterranean and Middle-Eastern countries. Sixty mutations have been described so far. We report a novel mutation in the GHR gene in a patient with LS. Genomic DNA sequencing of exon 5 revealed a TT insertion at nucleotide 422 after codon 122. The insertion resulted in a frameshift introducing a premature termination codon that led to a truncated receptor. We present clinical, biochemical and molecular evidence of LS as the result of this homozygous insertion.

The Effect of Insertion Torque on the Clinical Outcome of Single Implants: A Randomized Clinical Trial.

PubMed

Barone, Antonio; Alfonsi, Fortunato; Derchi, Giacomo; Tonelli, Paolo; Toti, Paolo; Marchionni, Saverio; Covani, Ugo

2016-06-01

The insertion torque value has been extensively used as an indicator for implant primary stability, which is considered a determining parameter for the implants success. The primary goal of the present randomized clinical trial was to evaluate and compare the clinical outcome for implants placed with high insertion torque (between 50 Ncm and 100 Ncm) and regular insertion torque (within 50 Ncm) in healed ridges. Partially edentulous patients, missing one or more mandibular or maxillary teeth, having an adequate amount of bone, requiring implant placement, were randomized to receive Blossom CT implants with regular insertion torque (<50 Ncm) or CT implants with high insertion torque (≥50 Ncm). Implants were left to heal submerged for 3 months. Implants were restored with individualized abutments and cemented metal-ceramic crowns. Acquired measurements were: insertion torque values (IT), thickness of buccal bone plate after implant osteotomy preparation (BBT), marginal bone level (MBL), and facial soft tissue level (FST). All patients were followed 12 months after implant placement. One hundred sixteen implants were placed in one hundred sixteen patients and enrolled for the study. Fifty-eight implants were randomly allocated in regular-IT and high-IT groups with a mean insertion torque ranging from 20 Ncm to 50 Ncm and from 50 Ncm to 100 Ncm, respectively. Three implants failed, and another five implants showed at the 12-month evaluation a marginal bone loss (ΔMBL) greater than 1.5 mm, being considered unsuccessful. The findings suggested that implants inserted with high-IT (≥50 Ncm) in healed bone ridges showed more peri-implant bone remodeling and buccal soft tissue recession than implants inserted with a regular-IT (<50 Ncm). Moreover, sites with a thick buccal bone wall (≥1 mm) - after implant osteotomy site preparation - seemed to be less prone to buccal soft tissue recession after 12 months than sites with a thin buccal bone wall (<1 mm). © 2015 Wiley Periodicals, Inc.

Package Design Affects Accuracy Recognition for Medications.

PubMed

Endestad, Tor; Wortinger, Laura A; Madsen, Steinar; Hortemo, Sigurd

2016-12-01

Our aim was to test if highlighting and placement of substance name on medication package have the potential to reduce patient errors. An unintentional overdose of medication is a large health issue that might be linked to medication package design. In two experiments, placement, background color, and the active ingredient of generic medication packages were manipulated according to best human factors guidelines to reduce causes of labeling-related patient errors. In two experiments, we compared the original packaging with packages where we varied placement of the name, dose, and background of the active ingredient. Age-relevant differences and the effect of color on medication recognition error were tested. In Experiment 1, 59 volunteers (30 elderly and 29 young students), participated. In Experiment 2, 25 volunteers participated. The most common error was the inability to identify that two different packages contained the same active ingredient (young, 41%, and elderly, 68%). This kind of error decreased with the redesigned packages (young, 8%, and elderly, 16%). Confusion errors related to color design were reduced by two thirds in the redesigned packages compared with original generic medications. Prominent placement of substance name and dose with a band of high-contrast color support recognition of the active substance in medications. A simple modification including highlighting and placing the name of the active ingredient in the upper right-hand corner of the package helps users realize that two different packages can contain the same active substance, thus reducing the risk of inadvertent medication overdose. © 2016, Human Factors and Ergonomics Society.

Package Design Affects Accuracy Recognition for Medications

PubMed Central

Endestad, Tor; Wortinger, Laura A.; Madsen, Steinar; Hortemo, Sigurd

2016-01-01

Objective: Our aim was to test if highlighting and placement of substance name on medication package have the potential to reduce patient errors. Background: An unintentional overdose of medication is a large health issue that might be linked to medication package design. In two experiments, placement, background color, and the active ingredient of generic medication packages were manipulated according to best human factors guidelines to reduce causes of labeling-related patient errors. Method: In two experiments, we compared the original packaging with packages where we varied placement of the name, dose, and background of the active ingredient. Age-relevant differences and the effect of color on medication recognition error were tested. In Experiment 1, 59 volunteers (30 elderly and 29 young students), participated. In Experiment 2, 25 volunteers participated. Results: The most common error was the inability to identify that two different packages contained the same active ingredient (young, 41%, and elderly, 68%). This kind of error decreased with the redesigned packages (young, 8%, and elderly, 16%). Confusion errors related to color design were reduced by two thirds in the redesigned packages compared with original generic medications. Conclusion: Prominent placement of substance name and dose with a band of high-contrast color support recognition of the active substance in medications. Application: A simple modification including highlighting and placing the name of the active ingredient in the upper right-hand corner of the package helps users realize that two different packages can contain the same active substance, thus reducing the risk of inadvertent medication overdose. PMID:27591209

RD2-MolPack-Chim3, a packaging cell line for stable production of lentiviral vectors for anti-HIV gene therapy.

PubMed

Stornaiuolo, Anna; Piovani, Bianca Maria; Bossi, Sergio; Zucchelli, Eleonora; Corna, Stefano; Salvatori, Francesca; Mavilio, Fulvio; Bordignon, Claudio; Rizzardi, Gian Paolo; Bovolenta, Chiara

2013-08-01

Over the last two decades, several attempts to generate packaging cells for lentiviral vectors (LV) have been made. Despite different technologies, no packaging clone is currently employed in clinical trials. We developed a new strategy for LV stable production based on the HEK-293T progenitor cells; the sequential insertion of the viral genes by integrating vectors; the constitutive expression of the viral components; and the RD114-TR envelope pseudotyping. We generated the intermediate clone PK-7 expressing constitutively gag/pol and rev genes and, by adding tat and rd114-tr genes, the stable packaging cell line RD2-MolPack, which can produce LV carrying any transfer vector (TV). Finally, we obtained the RD2-MolPack-Chim3 producer clone by transducing RD2-MolPack cells with the TV expressing the anti-HIV transgene Chim3. Remarkably, RD114-TR pseudovirions have much higher potency when produced by stable compared with transient technology. Most importantly, comparable transduction efficiency in hematopoietic stem cells (HSC) is obtained with 2-logs less physical particles respect to VSV-G pseudovirions produced by transient transfection. Altogether, RD2-MolPack technology should be considered a valid option for large-scale production of LV to be used in gene therapy protocols employing HSC, resulting in the possibility of downsizing the manufacturing scale by about 10-fold in respect to transient technology.

Self-pressurized air-Q® intubating laryngeal airway versus the LMA® Classic™: a randomized clinical trial.

PubMed

Ha, Sang Hee; Kim, Min-Soo; Suh, Jiwoo; Lee, Jong Seok

2018-05-01

The self-pressurized air-Q® (air-Q SP) intubating laryngeal airway is a relatively new supraglottic airway (SGA) device. The intracuff pressure of air-Q dynamically equilibrates with the airway pressure and adjusts to the patient's pharyngeal and periglottic anatomy, potentially providing improved airway fit and seal. The aim of this prospective randomized study was to compare the clinical performance of air-Q to the LMA® Classic™ SGA. Adult patients requiring general anesthesia for elective surgery were prospectively enrolled and randomly assigned to either air-Q SP or the LMA Classic SGA. Oropharyngeal leak pressure (primary endpoint), success rate, insertion features (insertion time, ease of insertion, requirement for device manipulation), sealing function, gastric insufflation, bronchoscopic view, and oropharyngeal complications at device insertion and following its removal (sore throat, dysphagia, dysphonia) were compared. The mean (standard deviation [SD]) oropharyngeal leak pressure just after insertion was similar in the air-Q SP and LMA [16.8 (4.9) vs 18.6 (5.5) cm H 2 O, respectively; mean difference, 1.8 cm H 2 O; 95% CI, -0.5 to 4.2; P = 0.13] and did not differ at ten minutes following device insertion. Median [interquartile range (IQR)] peak inspiratory pressure just after insertion was lower in the air-Q SP (11.0 [10.0-13.0] vs 13.0 [11.0-14.0] cmH 2 O, median difference, 1.0 cm H 2 O; 95% CI, 0.0 to 2.0; P = 0.03) but no difference was observed at ten minutes. The median [IQR] insertion time was faster with the air-Q SP (15.9 [13.6-20.3] sec vs 24 [21.2-27.1] sec; median difference, 8.1 sec; 95% CI, 5.6 to 9.9; P < 0.001) and improved bronchoscopic viewing grade were seen with the air-Q SP immediately after insertion (P < 0.001). No differences between the groups were observed with respect to the rate of successful insertion at first attempt, overall insertion success rate, ease of insertion, and complications. The air-Q SP had similar leak pressures but a faster insertion time and superior bronchoscopic viewing grade when compared with the LMA Classic. The air-Q SP is a suitable alternative to the LMA Classic in adult patients and may be a superior conduit for tracheal intubation. www.clinicaltrials.gov (NCT02206438). Registered 1 August 2014.

Re-engineering adenovirus vector systems to enable high-throughput analyses of gene function.

PubMed

Stanton, Richard J; McSharry, Brian P; Armstrong, Melanie; Tomasec, Peter; Wilkinson, Gavin W G

2008-12-01

With the enhanced capacity of bioinformatics to interrogate extensive banks of sequence data, more efficient technologies are needed to test gene function predictions. Replication-deficient recombinant adenovirus (Ad) vectors are widely used in expression analysis since they provide for extremely efficient expression of transgenes in a wide range of cell types. To facilitate rapid, high-throughput generation of recombinant viruses, we have re-engineered an adenovirus vector (designated AdZ) to allow single-step, directional gene insertion using recombineering technology. Recombineering allows for direct insertion into the Ad vector of PCR products, synthesized sequences, or oligonucleotides encoding shRNAs without requirement for a transfer vector Vectors were optimized for high-throughput applications by making them "self-excising" through incorporating the I-SceI homing endonuclease into the vector removing the need to linearize vectors prior to transfection into packaging cells. AdZ vectors allow genes to be expressed in their native form or with strep, V5, or GFP tags. Insertion of tetracycline operators downstream of the human cytomegalovirus major immediate early (HCMV MIE) promoter permits silencing of transgenes in helper cells expressing the tet repressor thus making the vector compatible with the cloning of toxic gene products. The AdZ vector system is robust, straightforward, and suited to both sporadic and high-throughput applications.

Life cycle assessment of EPS and CPB inserts: design considerations and end of life scenarios.

PubMed

Tan, Reginald B H; Khoo, Hsien H

2005-02-01

Expanded polystyrene (EPS) and corrugated paperboard (CPB) are used in many industrial applications, such as containers, shock absorbers or simply as inserts. Both materials pose two different types of environmental problems. The first is the pollution and resource consumption that occur during the production of these materials; the second is the growing landfills that arise out of the excessive disposal of these packaging materials. Life cycle assessment or LCA will be introduced in this paper as a useful tool to compare the environmental performance of both EPS and CPB throughout their life cycle stages. This paper is divided into two main parts. The first part investigates the environmental impacts of the production of EPS and CPB from 'cradle-to-gate', comparing two inserts--both the original and proposed new designs. In the second part, LCA is applied to investigate various end-of-life cases for the same materials. The study will evaluate the environmental impacts of the present waste management practices in Singapore. Several 'what-if' cases are also discussed, including various percentages of landfilling and incineration. The SimaPro LCA Version 5.0 software's Eco-indicator 99 method is used to investigate the following five environmental impact categories: climate change, acidification/eutrophication, ecotoxicity, fossil fuels and respiratory inorganics.

Alu element insertion in PKLR gene as a novel cause of pyruvate kinase deficiency in Middle Eastern patients.

PubMed

Lesmana, Harry; Dyer, Lisa; Li, Xia; Denton, James; Griffiths, Jenna; Chonat, Satheesh; Seu, Katie G; Heeney, Matthew M; Zhang, Kejian; Hopkin, Robert J; Kalfa, Theodosia A

2018-03-01

Pyruvate kinase deficiency (PKD) is the most frequent red blood cell enzyme abnormality of the glycolytic pathway and the most common cause of hereditary nonspherocytic hemolytic anemia. Over 250 PKLR-gene mutations have been described, including missense/nonsense, splicing and regulatory mutations, small insertions, small and gross deletions, causing PKD and hemolytic anemia of variable severity. Alu retrotransposons are the most abundant mobile DNA sequences in the human genome, contributing to almost 11% of its mass. Alu insertions have been associated with a number of human diseases either by disrupting a coding region or a splice signal. Here, we report on two unrelated Middle Eastern patients, both born from consanguineous parents, with transfusion-dependent hemolytic anemia, where sequence analysis revealed a homozygous insertion of AluYb9 within exon 6 of the PKLR gene, causing precipitous decrease of PKLR RNA levels. This Alu element insertion consists a previously unrecognized mechanism underlying pathogenesis of PKD. © 2017 Wiley Periodicals, Inc.

Peritoneal Dialysis Catheter Insertion.

PubMed

Crabtree, John H; Chow, Kai-Ming

2017-01-01

The success of peritoneal dialysis as renal-replacement therapy depends on a well-functioning peritoneal catheter. Knowledge of best practices in catheter insertion can minimize the risk of catheter complications that lead to peritoneal dialysis failure. The catheter placement procedure begins with preoperative assessment of the patient to determine the most appropriate catheter type, insertion site, and exit site location. Preoperative preparation of the patient is an instrumental step in facilitating the performance of the procedure, avoiding untoward events, and promoting the desired outcome. Catheter insertion methods include percutaneous needle-guidewire with or without image guidance, open surgical dissection, peritoneoscopic procedure, and surgical laparoscopy. The insertion technique used often depends on the geographic availability of material resources and local provider expertise in placing catheters. Independent of the catheter implantation approach, adherence to a number of universal details is required to ensure the best opportunity for creating a successful long-term peritoneal access. Finally, appropriate postoperative care and catheter break-in enables a smooth transition to dialysis therapy. Copyright © 2017 Elsevier Inc. All rights reserved.

The R package 'icosa' for coarse resolution global triangular and penta-hexagonal gridding

NASA Astrophysics Data System (ADS)

Kocsis, Adam T.

2017-04-01

With the development of the internet and the computational power of personal computers, open source programming environments have become indispensable for science in the past decade. This includes the increase of the GIS capacity of the free R environment, which was originally developed for statistical analyses. The flexibility of R made it a preferred programming tool in a multitude of disciplines from the area of the biological and geological sciences. Many of these subdisciplines operate with incidence (occurrence) data that are in a large number of cases to be grained before further analyses can be conducted. This graining is executed mostly by gridding data to cells of a Gaussian grid of various resolutions to increase the density of data in a single unit of the analyses. This method has obvious shortcomings despite the ease of its application: well-known systematic biases are induced to cell sizes and shapes that can interfere with the results of statistical procedures, especially if the number of incidence points influences the metrics in question. The 'icosa' package employs a common method to overcome this obstacle by implementing grids with roughly equal cell sizes and shapes that are based on tessellated icosahedra. These grid objects are essentially polyhedra with xyz Cartesian vertex data that are linked to tables of faces and edges. At its current developmental stage, the package uses a single method of tessellation which balances grid cell size and shape distortions, but its structure allows the implementation of various other types of tessellation algorithms. The resolution of the grids can be set by the number of breakpoints inserted into a segment forming an edge of the original icosahedron. Both the triangular and their inverted penta-hexagonal grids are available for creation with the package. The package also incorporates functions to look up coordinates in the grid very effectively and data containers to link data to the grid structure. The classes defined in the package are communicating with classes of the 'sp' and 'raster' packages and functions are supplied that allow resolution change and type conversions. Three-dimensional rendering is made available with the 'rgl' package and two-dimensional projections can be calculated using 'sp' and 'rgdal'. The package was developed as part of a project funded by the Deutsche Forschungsgemeinschaft (KO - 5382/1-1).

Impact of Drain Insertion After Perforated Peptic Ulcer Repair in a Japanese Nationwide Database Analysis.

PubMed

Okumura, K; Hida, K; Kunisawa, S; Nishigori, T; Hosogi, H; Sakai, Y; Imanaka, Y

2018-03-01

Many perforated peptic ulcers (PPUs) require surgical repair due to diffuse peritonitis. However, few studies have examined the clinical effects of postoperative drainage after PPU repair. This study aimed to investigate the drain insertion rates in patients who underwent PPU repair in Japan, and to clarify the impact of drain insertion on the postoperative clinical course. A retrospective nationwide cohort study was performed using administrative claims data of patients who had undergone PPU repair between 2010 and 2016. These patients were divided into two groups based on whether or not they had received a postoperative abdominal drain. Using propensity score matching, we compared the incidences of postoperative interventions for abdominal complications between both groups. A total of 4869 patients from 324 hospitals were analyzed. At the hospital level, drains were placed in all PPU repair patients in 229 (70.7%) hospitals. At the patient level, 4401 patients (90.4%) had drains inserted. The drain group was associated with a higher emergency admission rate, poorer preoperative shock status, longer anesthetic time, and a higher amount of intra-abdominal irrigation. In the propensity score-matched patients, the drain group had a significantly lower incidence of postoperative interventions than the no-drain group (1.9 vs. 5.6%; risk ratio = 0.35; 95% confidence interval 0.16-0.73; P = 0.003). Postoperative drainage was performed in the majority of patients who underwent PPU repair in Japan. Drainage following PPU repair may facilitate patient recovery by reducing the need for postoperative interventions.

Evaluation of Risk Versus Benefit Information in Direct-To-Consumer (DTC) Prescription Drug Television Advertisements.

PubMed

Fahim, Germin; Toscani, Michael; Barone, Joseph A; Wang, Chris; Gandhi, Shivani

2018-01-01

The FDA's Presenting Risk Information draft guidance from May 2009 states that the time of risk versus benefit is a factor taken into consideration when evaluating audio and video direct-to-consumer (DTC) broadcasts. The objective of the study is to evaluate the proportion of risk narration on television (TV) advertisements in comparison to the actual proportion of serious adverse effects findings across select therapeutic areas. The study reviews prescription drug TV advertisements between the years 2010 and 2015 separated by therapeutic class. Indicators to assess risk versus benefit are as follows: total benefit time, total risk time, total ad time, percentage proportion of risk, and number of serious adverse effects (SAEs) listed in the package insert. The objective is establishing proportion of risk-to-benefit narration across therapeutic areas and the proportion of risk narration compared to the number of SAEs in the package insert. These outcomes will reflect whether TV advertisements abide by the "fair balance" rule and if the time spent on risk narrations is proportional to the number of SAEs across therapeutic areas. An analysis of risk versus benefit showed that there was a vast range of percentage differences in risk versus benefit narration across the products selected. The majority of the products narrated showed a 40% to 60% risk-to-benefit ratio. Six out of the 10 products evaluated communicated applicable black box warnings. There was variability among the SAE percentages presented between products. Lack of consistency exists between risks versus benefit proportions among different drug products.

The increase in prescriptions of bisphosphonates and the incidence proportion of osteonecrosis of the jaw after risk communication activities in Japan: a hospital-based cohort study†

PubMed Central

Sumi, Eriko; Yamazaki, Toru; Tanaka, Shiro; Yamamoto, Keiichi; Nakayama, Takeo; Bessho, Kazuhisa; Yokode, Masayuki

2014-01-01

Purpose The purpose of this study was to investigate the impact of risk communication about bisphosphonate (BP)-related osteonecrosis of the jaw (ONJ) on the number of reported cases to the Drug Adverse Reactions Reporting System and on the incidence proportion of ONJ in a hospital-based cohort study in Japan. Method We conducted a survey of the safety information on BP-related ONJ available from regulatory authorities, pharmaceutical manufacturers and academic associations. We also performed a trend analysis of a dataset from the Drug Adverse Reactions Reporting System and a sub-analysis, using previously constructed data from a retrospective cohort study. Results Risk communication from pharmaceutical manufacturers and academic associations began within 1 year after revisions were made to the package inserts, in October 2006. Twenty times more cases of ONJ have been reported to regulatory authority since 2007, compared with the period before 2007. In our cohort, the incidence proportion of ONJ during and after 2009 was four times greater than before 2009. During this period, BPs were frequently prescribed, whereas there was no increase in the use of alternative agents, such as selective estrogen receptor modulators. Conclusion ONJ was increasingly diagnosed after risk communication efforts, but the impact of the communications was not clear. Safety notifications were diligently disseminated after the package insert was revised. However, there was no surveillance for ONJ before the revision. © 2014 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd. PMID:24399628

Factors influencing subjects' comprehension of a set of medicine package inserts.

PubMed

Pires, Carla; Vigário, Marina; Cavaco, Afonso

2016-08-01

Background Package inserts (PIs) should promote the safe and effective use of medicines. The comprehension of PIs is related to socio-demographic features, such as education. Objectives To evaluate the participants' comprehension of a sample of PIs and to build an explanatory model of subjects' understanding of the content of these documents. Setting The data were collected from municipalities, city halls, firefighters, the military, schools and charities from two Portuguese regions. Methods Cross-sectional descriptive survey: 503 participants, homogeneously distributed by education and gender. The self-administered tool comprised questions on socio-demographic data, literacy tasks and comprehension evaluation of 12 purposively selected PIs. A logistic regression analysis was used. Main outcome measures Scores of numeracy tasks and comprehension. Results The average comprehension score for the PIs was 63 % (±32 %), with 48 % (n = 239) of the participants scoring <75 %. The most important predictors in explaining a comprehension score ≥75 % were having >12 years of education and correctly performing a numeracy task [respectively, OR 49.6 (CI 95 %: 22.8-108) and OR 2.48 (CI 95 %: 1.5-4.2)]. Conclusion An explanatory model of subjects' knowledge about the content of the tested PIs was built. Given that a high level of education and literacy were found to be the most relevant predictors for acceptable comprehension rates, PIs should be clearly written to assure that they are understood by all potential users, including the less educated. The evaluated PIs may thus need to be simplified.

Medication Safety During Pregnancy: Improving Evidence-Based Practice.

PubMed

Sinclair, Susan M; Miller, Richard K; Chambers, Christina; Cooper, Elizabeth M

2016-01-01

Nearly 90% of women in the United States have taken medications during pregnancy. Medication exposures during pregnancy can result in adverse pregnancy and neonatal outcomes including birth defects, fetal loss, intrauterine growth restriction, prematurity, and longer-term neurodevelopmental outcomes. Advising pregnant women about the safety of medication use during pregnancy is complicated by a lack of data necessary to engage the woman in an informed discussion. Routinely, health care providers turn to the package insert, yet this information can be incomplete and can be based entirely on animal studies. Often, adequate safety data are not available. In a busy clinical setting, health care providers need to be able to quickly locate the most up-to-date information in order to counsel pregnant women concerned about medication exposure. Deciding where to locate the best available information is difficult, particularly when the needed information does not exist. Pregnancy registries are initiated to obtain more data about the safety of specific medication exposures during pregnancy; however, these studies are slow to produce meaningful information, and when they do, the information may not be readily available in a published form. Health care providers have valuable data in their everyday practice that can expand the knowledge base about medication safety during pregnancy. This review aims to discuss the limitations of the package insert regarding medication safety during pregnancy, highlight additional resources available to health care providers to inform practice, and communicate the importance of pregnancy registries for expanding knowledge about medication safety during pregnancy. © 2016 by the American College of Nurse-Midwives.

An evaluation of the completeness of drug-drug interaction-related information in package inserts.

PubMed

Ng, Giok Qin; Sklar, Grant Edward; Chng, Hui Ting

2017-02-01

The project aimed to evaluate the completeness of drug-drug interaction (DDI)-related information in package inserts (PIs) and develop a systematic approach to conduct the evaluation. DDI-related information in the branded PIs of statins, macrolides, protease inhibitors and selected drugs of narrow therapeutic index (DNTI) were evaluated against the criteria distilled from the Food and Drug Administration (FDA) labelling recommendation guidance document. Decision trees were crafted and employed in the evaluation process. Scores were computed to give each PI an overall completeness score and individual criterion completeness score. The Kruskal-Wallis test and Dunn's multiple comparison test were used to assess the differences in the completeness scores. The mean overall completeness score of the 21 PIs was 35.7 ± 13.4 % (range 12.2-62 %). Eight out of the 11 individual evaluation criterion had a mean completeness score below 50 %. A subclass analysis conducted revealed that PIs from the different drug classes differed in the type of DDI-related information, such that they are more complete or less complete. The completeness score of DDI-related information in the PIs varied extensively amongst and within drug classes. A consensus between the authorities and drug companies on the type and quality of DDI-related information to be included could improve their completeness in PIs and make PIs a valuable source of DDI reference. Decision trees, albeit not validated yet, lay the groundwork for a valuable tool to evaluate DDI-related or other drug information.

Do laboratories follow heart failure recommendations and guidelines and did we improve? The CARdiac MArker Guideline Uptake in Europe (CARMAGUE).

PubMed

Hammerer-Lercher, Angelika; Collinson, Paul; van Dieijen-Visser, Marja P; Pulkki, Kari; Suvisaari, Janne; Ravkilde, Jan; Stavljenic-Rukavina, Ana; Baum, Hannsjörg; Laitinen, Päivi

2013-06-01

Natriuretic peptides (NP) are well-established markers of heart failure (HF). During the past 5 years, analytical and clinical recommendations for measurement of these biomarkers have been published in guidelines. The aim of this follow-up survey was to investigate how well these guidelines for measurement of NP have been implemented in laboratory practice in Europe. Member societies of the European Federation of Clinical Chemistry and Laboratory Medicine were invited in 2009 to participate in a web-based audit questionnaire. The questionnaire requested information on type of tests performed, decision limits for HF, turn-around time and frequency of testing. There was a moderate increase (12%) of laboratories measuring NP compared to the initial survey in 2006. The most frequently used HF decision limits for B-type NP (BNP) and N-terminal BNP (NT-proBNP) were, respectively, 100 ng/L and 125 ng/L, derived from the package inserts in 55%. Fifty laboratories used a second decision limit. Age or gender dependent decision limits were applied in 10% (8.5% in 2006). The vast majority of laboratories (80%) did not have any criteria regarding frequency of testing, compared to 33% in 2006. The implementation of NP measurement for HF management was a slow process between 2006 and 2009 at a time when guidelines had just been established. The decision limits were derived from package insert information and literature. There was great uncertainty concerning frequency of testing which may reflect the debate about the biological variability which was not published for most of the assays in 2009.

Pressure redistribution by molded inserts in diabetic footwear: a pilot study.

PubMed

Lord, M; Hosein, R

1994-08-01

A small-scale trial is described to demonstrate and evaluate the redistribution of plantar pressure resulting from the use of custom-molded inserts in the orthopedic shoes of diabetic patients at risk of plantar ulceration. A pressure-measuring insole based on force-sensitive resistor technology enabled the load distribution to be compared using molded inserts and flat inserts fitted into the same shoes. An analysis of the 12 peaks of pressure that could be identified under a discrete metatarsal head of six subjects in the trial showed that the pressure was significantly reduced with the use of molded inserts (flat inserts: 305 +/- 79 kPa; molded inserts: 216 +/- 70 kPa; n = 6 p < 0.005). Technical limitations of the equipment and the difficult choice of match of flat insert to molded for comparison suggest that further studies are required for a definitive result.

Ahmed glaucoma valve implantation with tube insertion through the ciliary sulcus in pseudophakic/aphakic eyes.

PubMed

Eslami, Yadolla; Mohammadi, Massood; Fakhraie, Ghasem; Zarei, Reza; Moghimi, Sasan

2014-02-01

To report the efficacy and safety of Ahmed glaucoma valve (AGV) insertion into the ciliary sulcus in pseudophakic/aphakic patients. A chart review was done on patients with uncontrolled glaucoma, who underwent AGV implantation with tube inserted into the ciliary sulcus. Baseline intraocular pressure (IOP) and number of medications were compared with that of postoperative follow-up visits. Surgical success was defined as last IOP <21 mm Hg and 20% reduction in IOP, without further surgery for complications or glaucoma control, and without loss of light perception. Postoperative complications were recorded. Twenty-three eyes of 23 patients were recruited with the mean follow-up of 9 months (range, 3 to 24 mo). The mean (SD) age of patients was 49.9 (16.9) years (range, 22 to 80 years). The mean (SD) IOP (mm Hg) was reduced from 37.9 (12.4) before surgery to 16.2 (3.6) at the last follow-up visit (P<0.001). The mean (SD) number of medications was reduced from 3.3 (0.9) preoperatively to 1 (1.1) at the last follow-up (P<0.001). Success rate was 18/23 (78.6%). Complications included endophthalmitis in 1 eye, tube exposure in 1 diabetic patient, and vitreous tube occlusion in 1 eye. No case of corneal decompensation or graft failure was seen during follow-up. Ciliary sulcus placement of the tube of AGV effectively reduces IOP and medication use in short term. It has the potential to lower corneal complications of anterior chamber tube insertion and avoids the need for pars plana vitrectomy and tube insertion in patients at higher risk of corneal decompensation.

Experience in Bedside Placement, Clinical Validity, and Cost-Efficacy of a Self-Propelled Nasojejunal Feeding Tube

PubMed Central

Puiggròs, Carolina; Molinos, Rosa; Ortiz, M. Dolors; Ribas, Montserrat; Romero, Carlos; Vázquez, Concepcion; Segurola, Hegoi; Burgos, Rosa

2015-01-01

Background: The procedures needed to insert nasojejunal tubes (NJTs) are often invasive or uncomfortable for the patient and require hospital resources. The objectives of this study were to describe our experience in inserting a self-propelling NJT with distal pigtail end and evaluate clinical validity and cost efficacy of this enteral nutrition (EN) approach compared with parenteral nutrition (PN). Materials and Methods: Prospective study from July 2009 to December 2010, including hospitalized noncritical patients who required short-term jejunal EN. The tubes were inserted at bedside, using intravenous erythromycin as a prokinetic drug. Positioning was considered correct when the distal end was beyond the ligament of Treitz. Migration failure was considered when the tube was not positioned into the jejunum within 48 hours postinsertion. Results: Fifty-six insertions were recorded in 47 patients, most frequently in severe acute pancreatitis (69.6%). The migration rates at 18 and 48 hours postinsertion were 73.2% and 82.1%, respectively. There was migration failure in 8.9% of cases, and 8.9% were classified null (the tube was no longer in the gastrointestinal tract at 18 hours). There were no reported or observed complications. The mean duration of the EN was 12 ± 10.8 days. Five different types of EN formula were used. The total study cost was 53.9% lower compared with using PN in all patients. Conclusions: Our study demonstrated that bedside insertion of a self-propelling NJT is a safe, cost-effective, and successful technique for postpyloric enteral feeding in at least 73% of the patients, and only 18% of patients could eventually need other placement techniques. It can avoid the need for more aggressive or expensive placement techniques or even PN if we cannot achieve enteral access. PMID:26214512

A manpower scheduling heuristic for aircraft maintenance application

NASA Astrophysics Data System (ADS)

Sze, San-Nah; Sze, Jeeu-Fong; Chiew, Kang-Leng

2012-09-01

This research studies a manpower scheduling for aircraft maintenance, focusing on in-flight food loading operation. A group of loading teams with flexible shifts is required to deliver and upload packaged meals from the ground kitchen to aircrafts in multiple trips. All aircrafts must be served within predefined time windows. The scheduling process takes into account of various constraints such as meal break allocation, multi-trip traveling and food exposure time limit. Considering the aircrafts movement and predefined maximum working hours for each loading team, the main objective of this study is to form an efficient roster by assigning a minimum number of loading teams to the aircrafts. We proposed an insertion based heuristic to generate the solutions in a short period of time for large instances. This proposed algorithm is implemented in various stages for constructing trips due to the presence of numerous constraints. The robustness and efficiency of the algorithm is demonstrated in computational results. The results show that the insertion heuristic more efficiently outperforms the company's current practice.

Materials and structures technology insertion into spacecraft systems: Successes and challenges

NASA Astrophysics Data System (ADS)

Rawal, Suraj

2018-05-01

Over the last 30 years, significant advancements have led to the use of multifunctional materials and structures technologies in spacecraft systems. This includes the integration of adaptive structures, advanced composites, nanotechnology, and additive manufacturing technologies. Development of multifunctional structures has been directly influenced by the implementation of processes and tools for adaptive structures pioneered by Prof. Paolo Santini. Multifunctional materials and structures incorporating non-structural engineering functions such as thermal, electrical, radiation shielding, power, and sensors have been investigated. The result has been an integrated structure that offers reduced mass, packaging volume, and ease of integration for spacecraft systems. Current technology development efforts are being conducted to develop innovative multifunctional materials and structures designs incorporating advanced composites, nanotechnology, and additive manufacturing. However, these efforts offer significant challenges in the qualification and acceptance into spacecraft systems. This paper presents a brief overview of the technology development and successful insertion of advanced material technologies into spacecraft structures. Finally, opportunities and challenges to develop and mature next generation advanced materials and structures are presented.

SU-8 microprobe with microelectrodes for monitoring electrical impedance in living tissues.

PubMed

Tijero, M; Gabriel, G; Caro, J; Altuna, A; Hernández, R; Villa, R; Berganzo, J; Blanco, F J; Salido, R; Fernández, L J

2009-04-15

This paper presents a minimally invasive needle-shaped probe capable of monitoring the electrical impedance of living tissues. This microprobe consists of a 160 microm thick SU-8 substrate containing four planar platinum (Pt) microelectrodes. We design the probe to minimize damage to the surrounding tissue and to be stiff enough to be inserted in living tissues. The proposed batch fabrication process is low cost and low time consuming. The microelectrodes obtained with this process are strongly adhered to the SU-8 substrate and their impedance does not depend on frequency variation. In vitro experiments are compared with previously developed Si and SiC based microprobes and results suggest that it is preferable to use the SU-8 based microprobes due to their flexibility and low cost. The microprobe is assembled on a flexible printed circuit FPC with a conductive glue, packaged with epoxy and wired to the external instrumentation. This flexible probe is inserted into a rat kidney without fracturing and succeeds in demonstrating the ischemia monitoring.

Intracochlear Pressure Transients During Cochlear Implant Electrode Insertion.

PubMed

Greene, Nathaniel T; Mattingly, Jameson K; Banakis Hartl, Renee M; Tollin, Daniel J; Cass, Stephen P

2016-12-01

Cochlear implant (CI) electrode insertion into the round window induces pressure transients in the cochlear fluid comparable to high-intensity sound transients. Many patients receiving a CI have some remaining functional hearing at low frequencies; thus, devices and surgical techniques have been developed to use this residual hearing. To maintain functional acoustic hearing, it is important to retain function of any hair cells and auditory nerve fibers innervating the basilar membrane; however, in a subset of patients, residual low-frequency hearing is lost after CI insertion. Here, we test the hypothesis that transient intracochlear pressure spikes are generated during CI electrode insertion, which could cause damage and compromise residual hearing. Human cadaveric temporal bones were prepared with an extended facial recess. Pressures in the scala vestibuli and tympani were measured with fiber-optic pressure sensors inserted into the cochlea near the oval and round windows, whereas CI electrodes (five styles from two manufacturers) were inserted into the cochlea via a round window approach. Pressures in the scala tympani tended to be larger in magnitude than pressures in the scala vestibuli, consistent with electrode insertion into the scala tympani. CI electrode insertion produced a range of pressure transients in the cochlea that could occur alone or as part of a train of spikes with equivalent peak sound pressure levels in excess of 170 dB sound pressure level. Instances of pressure transients varied with electrode styles. Results suggest electrode design, insertion mechanism, and surgical technique affect the magnitude and rate of intracochlear pressure transients during CI electrode insertion. Pressure transients showed intensities similar to those elicited by high-level sounds and thus could cause damage to the basilar membrane and/or hair cells.

Intracochlear pressure transients during cochlear implant electrode insertion

PubMed Central

Greene, Nathaniel T.; Mattingly, Jameson K.; Banakis Hartl, Renee M.; Tollin, Daniel J.; Cass, Stephen P.

2016-01-01

Hypothesis Cochlear implant (CI) electrode insertion into the round window induces pressure transients in the cochlear fluid comparable to high intensity sound transients. Background Many patients receiving a CI have some remaining functional hearing at low frequencies, thus devices and surgical techniques have been developed to utilize this residual hearing. To maintain functional acoustic hearing, it is important to retain function of any hair cells and auditory nerve fibers innervating the basilar membrane; however, in a subset of patients, residual low frequency hearing is lost following CI insertion. Here, we test the hypothesis that transient intracochlear pressure spikes are generated during CI electrode insertion, which could cause damage and compromise residual hearing. Methods Human cadaveric temporal bones were prepared with an extended facial recess. Pressures in the scala vestibuli (PSV) and tympani (PST) were measured with fiber-optic pressure sensors inserted into the cochlea near the oval and round windows while CI electrodes (five styles from two manufacturers) were inserted into the cochlea via a round window approach. Results PST tended to be larger in magnitude than PSV, consistent with electrode insertion into the scala tympani. CI electrode insertion produced a range of pressure transients in the cochlea that could occur alone or as part of a train of spikes with equivalent peak sound pressure levels in excess of 170dB SPL. Instances of pressure transients varied with electrode styles. Conclusions Results suggest electrode design, insertion mechanism, and surgical technique affect the magnitude and rate of intracochlear pressure transients during CI electrode insertion. Pressure transients showed intensities similar to those elicited by high level sounds and thus could cause damage to the basilar membrane and/or hair cells. PMID:27753703

Practice variation in surgical procedures and IUD-insertions among general practitioners in Norway - a longitudinal study.

PubMed

Pahle, Andreas Saxlund; Sørli, Daniel; Kristiansen, Ivar Sønbø; Deraas, Trygve S; Halvorsen, Peder A

2017-01-21

Studies of Primary Health Care (PHC) reveal considerable practice variations in terms of the range of services provided. In Norway, general practitioners (GPs) are traditionally expected to perform IUD-insertions and several surgical procedures as a part of comprehensive PHC. We aimed to investigate variation in the provision of surgical procedures and IUD-insertions across GPs and over time and explore determinants of such variation. Retrospective registry study of Norwegian GPs. From a comprehensive database of GPs' reimbursement claims, we obtained procedure codes and GP characteristics such as age, gender, list size and municipality characteristics from 2006 through 2013. Multivariable logistic regression models were fitted to explore determinants of practice variation. We extracted data from 4,828 GPs. In 2013, 91.0, 76.1 and 74.8% were reimbursed at least once for minor and major surgical procedures and IUD-insertion, respectively. Female GPs had lower odds for performing major surgical procedures (OR 0.38, 95% CI 0.32-0.45) and higher odds for performing IUD-insertions (OR 6.28, 95% CI 4.47-8.82) than male GPs. Older GPs and GPs with shorter patient lists were less likely to perform surgical procedures. GPs with longer patient lists had higher odds for performing IUD-insertions. The proportion of GPs performing surgical procedures increased over time, while the proportion decreased for IUD-insertions. The number of IUD-insertions in specialist care increased from 12,575 in 2011 to 15 216 (+21.0%) in 2014. We observed a large variation in the provision of surgical procedures and IUD-insertions amongst GPs in Norway. The GPs' age, gender, list size and size of municipality were associated with performing the procedures. Our findings suggest a shift of IUD-insertions from primary to specialist care.

Gamma inert sterilization: a solution to polyethylene oxidation?

PubMed

Medel, Francisco J; Kurtz, Steven M; Hozack, William J; Parvizi, Javad; Purtill, James J; Sharkey, Peter F; MacDonald, Daniel; Kraay, Matthew J; Goldberg, Victor; Rimnac, Clare M

2009-04-01

In the 1990s, oxidation was found to occur in ultra-high molecular weight polyethylene total joint replacement components following gamma irradiation and prolonged shelf aging in air. Orthopaedic manufacturers developed barrier packaging to reduce oxidation during and after radiation sterilization. The present study explores the hypothesis that polyethylene components sterilized in a low-oxygen environment undergo similar in vivo oxidative mechanisms as inserts sterilized in air. In addition, the potential influence of the different sterilization processes on the wear performance of the polyethylene components was examined. An analysis of oxidation, wear, and surface damage was performed for forty-eight acetabular liners and 123 tibial inserts. The mean implantation time was 12.3+/-3.7 years for thirty-one acetabular liners that had been gamma sterilized in air and 4.0+/-2.5 years for the seventeen acetabular liners that had been gamma sterilized in inert gas. The mean implantation time was 11.0+/-3.2 years for the twenty-six tibial inserts that had been sterilized in air and 2.8+/-2.2 years for the ninety-seven tibial inserts that had been gamma sterilized in inert gas. Oxidation and hydroperoxide levels were characterized in loaded and unloaded regions of the inserts. Measurable oxidation and oxidation potential were observed in all cohorts. The oxidation and hydroperoxide levels were regional. Surfaces with access to body fluids were more heavily oxidized than protected bearing surfaces were. This variation appeared to be greater in historical (gamma-in-air-sterilized) components. Regarding wear performance, historical and conventional acetabular liners showed similar wear penetration rates, whereas a low incidence of delamination was confirmed for the conventional tibial inserts in the first decade of implantation. The present study explores the impact of industry-wide changes in sterilization practices for polyethylene. We found lower oxidation and oxidation potential in the conventional acetabular liners and tibial inserts that had been gamma sterilized in inert gas as compared with the historical components that had been gamma sterilized in air. However, we also found strong evidence that conventional components undergo mechanisms of in vivo oxidation similar to those observed following gamma irradiation in air. In addition, gamma sterilization in inert gas did not provide polyethylene with a significant improvement in terms of wear resistance as compared with gamma sterilization in air, except for a lower incidence of delamination in the first decade of implantation for tibial inserts.

Intravenous cannulation of adolescents does not affect the modulation of autonomic tone assessed by heart rate and blood pressure variability.

PubMed

Stewart, J M

2000-02-01

Invasive arterial monitoring alters autonomic tone. The effects of intravenous (i.v.) insertion are less clear. The author assessed the effects of i.v. insertion on autonomic activity in patients aged 11 to 19 years prior to head-up tilt by measuring heart rate, blood pressure, heart rate variability, blood pressure variability, and baroreceptor gain before and after i.v. insertion with continuous electrocardiography and arterial tonometry in patients with orthostatic tachycardia syndrome (OTS, N = 21), in patients who experienced simple fainting (N = 14), and in normal control subjects (N = 6). Five-minute samples were collected after 30 minutes supine. Fifteen minutes after i.v. insertion, data were collected again. These 5-minute samples were also collected in a separate control population without i.v. insertion after 30 minutes supine and again 30 minutes later. This population included 12 patients with OTS, 13 patients who experienced simple fainting, and 6 normal control subjects. Heart rate variability included the mean RR, the standard deviation of the RR interval (SDNN), and the root mean square of successive RR differences (RMSSD). Autoregressive spectral modeling was used. Low-frequency power (LFP, 0.04-0.15 Hz), high-frequency power (HFP, 0.15-0.40 Hz), and total power (TP, 0.01-0.40 Hz) were compared. Blood pressure variability included standard deviation of systolic blood pressure, LFP, and HFP. Baroreceptor gain at low frequency and high frequency was calculated from cross-spectral transfer function magnitudes when coherence was greater than 0.5. In patients with OTS, RR (790 +/- 50 msec), SDNN (54 +/- 6 msec), RMSSD (55 +/- 5 msec), LFP (422 +/- 200 ms2/Hz), HFP (846 +/- 400 ms2/Hz), and TP (1550 +/- 320 ms2/Hz) were less than in patients who experienced simple fainting (RR, 940 +/- 50 msec; SDNN, 84 +/- 10 msec; RMSSD, 91 +/- 7 msec; LFP, 880 +/- 342 ms2/Hz; HFP, 1720 +/- 210 ms2/Hz; and TP, 3228 +/- 490 ms2/Hz) or normal control subjects (RR, 920 +/- 30 msec; SDNN, 110 +/- 29 msec; RMSSD, 120 +/- 16 msec; LFP, 1600 +/- 331 ms2/Hz; HFP, 2700 +/- 526 ms2/Hz; and TP, 5400 +/- 1017 ms2/Hz). Blood pressure and blood pressure variability were not different in any group. Standard deviation, LFP, and HFP were, respectively, 5.24 +/- 0.8 mm Hg, 1.2 +/- 0.2, and 1.5 +/- 0.3 for patients with OTS; 4.6 +/- 0.4 mm Hg, 1.2 +/- 0.2, and 1.4 +/- 0.3 for patients who experienced simple fainting; and 5.55 +/- 1.0 mm Hg, 1.4 +/- 0.2, and 1.6 +/- 0.3 for normal control subjects. Baroreceptor gain at low frequency and high frequency in patients with OTS (16 +/- 4 msec/mm Hg, 17 +/- 5) was comparable to that in patients who experienced simple fainting (33 +/- 4, 32 +/- 3) and that in normal control subjects (31 +/- 8, 37 +/- 9). Heart rate variability differed between patients with OTS and patients who experienced simple fainting or normal control subjects, and blood pressure and blood pressure variability were not different, but no parameter changed after i.v. insertion. There were no differences from the groups that did not receive i.v. insertions. Data suggest, at most, a limited effect of i.v. insertion on autonomic function in adolescents.

Guidewire exchange vs new site placement for temporary dialysis catheter insertion in ICU patients: is there a greater risk of colonization or dysfunction?

PubMed

Coupez, Elisabeth; Timsit, Jean-François; Ruckly, Stéphane; Schwebel, Carole; Gruson, Didier; Canet, Emmanuel; Klouche, Kada; Argaud, Laurent; Bohe, Julien; Garrouste-Orgeas, Maïté; Mariat, Christophe; Vincent, François; Cayot, Sophie; Cointault, Olivier; Lepape, Alain; Darmon, Michael; Boyer, Alexandre; Azoulay, Elie; Bouadma, Lila; Lautrette, Alexandre; Souweine, Bertrand

2016-07-30

Intensive care unit (ICU) patients require dialysis catheters (DCs) for renal replacement therapy (RRT). They carry a high risk of developing end-stage renal disease, and therefore their vascular access must be preserved. Guidewire exchange (GWE) is often used to avoid venipuncture insertion (VPI) at a new site. However, the impact of GWE on infection and dysfunction of DCs in the ICU is unknown. Our aim was to compare the effect of GWE and VPI on DC colonization and dysfunction in ICU patients. Using data from the ELVIS randomized controlled trial (RCT) (1496 ICU adults requiring DC for RRT or plasma exchange) we performed a matched-cohort analysis. Cases were DCs inserted by GWE (n = 178). They were matched with DCs inserted by VPI. Matching criteria were participating centre, simplified acute physiology score (SAPS) II +/-10, insertion site (jugular or femoral), side for jugular site, and length of ICU stay before DC placement. We used a marginal Cox model to estimate the effect of DC insertion (GWE vs. VPI) on DC colonization and dysfunction. DC colonization rate was not different between GWE-DCs and VPI-DCs (10 (5.6 %) for both groups) but DC dysfunction was more frequent with GWE-DCs (67 (37.6 %) vs. 28 (15.7 %); hazard ratio (HR), 3.67 (2.07-6.49); p < 0.01). Results were similar if analysis was restricted to DCs changed for dysfunction. GWE for DCs in ICU patients, compared with VPI did not contribute to DC colonization or infection but was associated with more than twofold increase in DC dysfunction. This study is registered with ClinicalTrials.gov, number NCT00563342 . Registered 2 April 2009.

An Algorithmic, Pie-Crusting Medial Soft Tissue Release Reduces the Need for Constrained Inserts Patients With Severe Varus Deformity Undergoing Total Knee Arthroplasty.

PubMed

Goudarz Mehdikhani, Kaveh; Morales Moreno, Beatriz; Reid, Jeremy J; de Paz Nieves, Ana; Lee, Yuo-Yu; González Della Valle, Alejandro

2016-07-01

We studied the need to use a constrained insert for residual intraoperative instability and the 1-year result of patients undergoing total knee arthroplasty (TKA) for a varus deformity. In a control group, a "classic" subperiosteal release of the medial soft tissue sleeve was performed as popularized by pioneers of TKA. In the study group, an algorithmic approach that selectively releases and pie-crusts posteromedial structures in extension and anteromedial structures in flexion was used. All surgeries were performed by a single surgeon using measured resection technique, and posterior-stabilized, cemented implants. There were 228 TKAs in the control group and 188 in the study group. Outcome variables included the use of a constrained insert, and the Knee Society Score at 6 weeks, 4 months, and 1 year postoperatively. The effect of the release technique on use of constrained inserts and clinical outcomes were analyzed in a multivariate model controlling for age, sex, body mass index, and severity of deformity. The use of constrained inserts was significantly lower in study than in control patients (8% vs 18%; P = .002). There was no difference in the Knee Society Score and range of motion between the groups at last follow-up. No patient developed postoperative medial instability. This algorithmic, pie-crusting release technique resulted in a significant reduction in the use of constrained inserts with no detrimental effects in clinical results, joint function, and stability. As constrained TKA implants are more costly than nonconstrained ones, if the adopted technique proves to be safe in the long term, it may cause a positive shift in value for hospitals and cost savings in the health care system. Copyright © 2016 Elsevier Inc. All rights reserved.

Medicare's "Global" terrorism: where is the pay for performance?

PubMed

Reed, R Lawrence; Luchette, Fred A; Esposito, Thomas J; Pyrz, Karen; Gamelli, Richard L

2008-02-01

Medicare and Medicaid Services (CMS) payment policies for surgical operations are based on a global package concept. CMS' physician fee schedule splits the global package into preoperative, intraoperative, and postoperative components of each procedure. We hypothesized that these global package component valuations were often lower than comparable evaluation and management (E&M) services and that billing for E&M services instead of the operation could often be more profitable. Our billing database and Trauma Registry were queried for the operative procedures and hospital lengths of stay for trauma patients during the past 5 years. Determinations of preoperative, intraoperative, and postoperative payments were calculated for 10-day and 90-day global packages, comparing them to CMS payments for comparable E&M codes. Of 90-day and 10-day Current Procedural Terminology codes, 88% and 100%, respectively, do not pay for the comprehensive history and physical that trauma patients usually receive, whereas 41% and 98%, respectively, do not even meet payment levels for a simple history and physical. Of 90-day global package procedures, 70% would have generated more revenue had comprehensive daily visits been billed instead of the operation ($3,057,500 vs. $1,658,058). For 10-day global package procedures, 56% would have generated more revenue with merely problem-focused daily visits instead of the operation ($161,855 vs. $156,318). Medicare's global surgical package underpays E&M services in trauma patients. In most cases, trauma surgeons would fare better by not billing for operations to receive higher reimbursement for E&M services that are considered "bundled" in the global package payment.

A Study of Use of “PORT” Catheter in Patients with Cancer: A Single-Center Experience

PubMed Central

Madabhavi, Irappa; Patel, Apurva; Sarkar, Malay; Anand, Asha; Panchal, Harsha; Parikh, Sonia

2017-01-01

Background: Effective and reliable venous access is one of the cornerstones of modern medical therapy in oncology. Materials and methods: This is a prospective observational study, which collected data of patients who require “PORT” catheter insertion for any cancer, at a tertiary care oncology hospital in Ahmadabad, Gujarat, India, during a 2-year period. Aims and objectives: The main objective of this study was to study the various complications and outcomes related to “PORT” catheters. Results: “PORT” catheter was inserted in 100 patients and was most commonly used in solid malignancies (n = 86, 86%), followed by hematologic malignancies (n = 14, 14%). Among the solid malignancies, breast cancer (38, 38%) was the most common underlying disease, whereas among the hematologic malignancies, acute lymphoblastic leukemia (6, 6%) was the most common underlying disease for “PORT” catheter insertion. Chemotherapy was started on the first day of “PORT” catheter in 74% of patients in the “PORT” study group. The various complications developed in the “PORT” study group in the descending order are as follows: 4 patients (4%) developed early infection (⩽30 days after “PORT” placement), 4 (4%) late infection (⩾30 days after “PORT” placement), 4 (4%) bloodstream infection, 2 (2%) local skin infection at the “PORT” insertion site, 2 (2%) dislodgment of the “PORT” catheter, 2 (2%) fracture of the “PORT” catheter, and 1 recurrent pleural effusion. One patient (1%) developed thrombosis as the complication of “PORT” catheter insertion. Conclusions: The most disturbing aspect of treatment for a patient with cancer is multiple painful venipunctures made for administration of cytotoxic agents, antibiotics, blood products, and nutritional supplements. The focus of this prospective observational research is to study the various underlying diseases for which “PORT” catheter is needed in different solid and hematologic malignancies and the various complications and outcomes in pediatric and adult patients with cancer. PMID:28469510

Prophylactic teicoplanin during insertion of Hickman catheters.

PubMed

Lim, S H; Smith, M P; Machin, S J; Goldstone, A H

1990-12-01

With the extensive use of Hickman catheters in patients requiring cytotoxic chemotherapy there is now a resurgence of Gram-positive septicaemia among these patients during the neutropenic periods. We are currently running a prospective randomized study of prophylactic teicoplanin during insertion of Hickman catheters to determine if it reduces the incidence of Gram-positive septicaemia. A total of 44 patients have completed the study (23 in the teicoplanin group and 21 in the control group). The diagnoses were: acute myelogenous leukaemia (13), non-Hodgkin's lymphoma (16), Hodgkin's disease (11), chronic granulocytic leukaemia (3) and acute lymphoblastic leukaemia (1). The number of days between insertion of Hickman catheters and the development of neutropenia was: teicoplanin group: mean 14.7, median 11, range 0-53; control group: mean 11.8, median 10, range 0-37. In the treated patients, there were four episodes of line-associated Gram-positive septicaemia and a total of four organisms were isolated. In the control group, 10 organisms were isolated from a total of nine episodes of line-associated Gram-positive septicaemia. The organisms were: coagulase-negative staphylococci (8), Streptococcus B, (1), Strep. faecalis (1), Strep. mitis (1), alpha streptococcus (1), diphtheriods (1) and Staphylococcus aureus (1). All organisms were sensitive to teicoplanin. No adverse reaction was observed in any patient. Prophylactic teicoplanin during insertion of Hickman catheters may therefore reduce the incidence of line-associated Gram-positive septicaemia in neutropenic patients.

Ten years single-centre experience with intra-aortic balloon pump.

PubMed

Vandenplas, Guy; Bové, Thierry; Caes, Frank; Van Belleghem, Yves; François, Katrien; De Somer, Filip; Taeymans, Yves; Van Nooten, Guido

2011-12-01

The objective of this study was to investigate the patient characteristics and outcomes in 1406 patients undergoing intra-aortic balloon pump (IABP) counterpulsation. Between 1998 and 2008, 1406 consecutive patients were recorded in a prospective database. Based on the main clinical indication for IABP use, we defined 3 groups: group A, 630 cases of coronary ischaemia or infarction without serious left ventricular (LV) dysfunction; group B, 466 patients with left ventricular failure or cardiogenic shock; group C, 310 patients where IABP was used for miscellaneous procedures such as weaning from cardiopulmonary bypass or during high-risk angioplasty or surgery. Global mortality was 28% (n = 390), with a significant difference between group A (15%, n = 95) and group B (41%, n = 191) (P < 0.001). Mortality in group C was 34% (n = 104). Most insertions were done in the catheterization laboratory (n = 943) with subsequent mortality of 23% whereas 199 balloons were inserted in the operation room with 34% mortality. 170 balloons inserted in the intensive care unit resulted in 46% mortality (P < 0.001). Major IABP-induced complications were 6.8% with no statistical differences between the three groups. Advanced age, left ventricular failure and low BMI were identified as prognostic risk factors for early mortality. IABP deployed at an early clinical stage yields the best results, especially for acute coronary patients with preserved LV function whereas LV failure and late insertion result in worse outcome.

Comparison of routes for achieving parenteral access with a focus on the management of patients with Ebola virus disease.

PubMed

Ker, Katharine; Tansley, Gavin; Beecher, Deirdre; Perner, Anders; Shakur, Haleema; Harris, Tim; Roberts, Ian

2015-02-26

Dehydration is an important cause of death in patients with Ebola virus disease (EVD). Parenteral fluids are often required in patients with fluid requirements in excess of their oral intake. The peripheral intravenous route is the most commonly used method of parenteral access, but inserting and maintaining an intravenous line can be challenging in the context of EVD. Therefore it is important to consider the advantages and disadvantages of different routes for achieving parenteral access (e.g. intravenous, intraosseous, subcutaneous and intraperitoneal). To compare the reliability, ease of use and speed of insertion of different parenteral access methods. We ran the search on 17 November 2014. We searched the Cochrane Injuries Group's Specialised Register, Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library), Ovid MEDLINE(R) In-Process & Other Non-Indexed Citations, Ovid MEDLINE(R) Daily, Ovid MEDLINE(R) and Ovid OLDMEDLINE(R), Embase Classic + Embase (OvidSP), CINAHL (EBSCOhost), clinicaltrials.gov and screened reference lists. Randomised controlled trials comparing different parenteral routes for the infusion of fluids or medication. Two review authors examined the titles and abstracts of records obtained by searching the electronic databases to determine eligibility. Two review authors extracted data from the included trials and assessed the risk of bias. Outcome measures of interest were success of insertion; time required for insertion; number of insertion attempts; number of dislodgements; time period with functional access; local site reactions; clinicians' perception of ease of administration; needlestick injury to healthcare workers; patients' discomfort; and mortality. For trials involving the administration of fluids we also collected data on the volume of fluid infused, changes in serum electrolytes and markers of renal function. We rated the quality of the evidence as 'high', 'moderate', 'low' or 'very low' according to the GRADE approach for the following outcomes: success of insertion, time required for insertion, number of dislodgements, volume of fluid infused and needlestick injuries. We included 17 trials involving 885 participants. Parenteral access was used to infuse fluids in 11 trials and medications in six trials. None of the trials involved patients with EVD. Intravenous and intraosseous access was compared in four trials; intravenous and subcutaneous access in 11; peripheral intravenous and intraperitoneal access in one; saphenous vein cutdown and intraosseous access in one; and intraperitoneal with subcutaneous access in one. All of the trials assessing the intravenous method involved peripheral intravenous access.We judged few trials to be at low risk of bias for any of the assessed domains.Compared to the intraosseous group, patients in the intravenous group were more likely to experience an insertion failure (risk ratio (RR) 3.89, 95% confidence interval (CI) 2.39 to 6.33; n = 242; GRADE rating: low). We did not pool data for time to insertion but estimates from the trials suggest that inserting intravenous access takes longer (GRADE rating: moderate). Clinicians judged the intravenous route to be easier to insert (RR 0.15, 95% CI 0.04 to 0.61; n = 182). A larger volume of fluids was infused via the intravenous route (GRADE rating: moderate). There was no evidence of a difference between the two routes for any other outcomes, including adverse events.Compared to the subcutaneous group, patients in the intravenous group were more likely to experience an insertion failure (RR 14.79, 95% CI 2.87 to 76.08; n = 238; GRADE rating: moderate) and dislodgement of the device (RR 3.78, 95% CI 1.16 to 12.34; n = 67; GRADE rating: low). Clinicians also judged the intravenous route as being more difficult to insert and patients were more likely to be agitated in the intravenous group. Patients in the intravenous group were more likely to develop a local infection and phlebitis, but were less likely to develop erythema, oedema or swelling than those in the subcutaneous group. A larger volume of fluids was infused into patients via the intravenous route. There was no evidence of a difference between the two routes for any other outcome.There were insufficient data to reliably determine if the risk of insertion failure differed between the saphenous vein cutdown (SVC) and intraosseous method (RR 4.00, 95% CI 0.51 to 31.13; GRADE rating: low). Insertion using SVC took longer than the intraosseous method (MD 219.60 seconds, 95% CI 135.44 to 303.76; GRADE rating: moderate). There were no data and therefore there was no evidence of a difference between the two routes for any other outcome.There were insufficient data to reliably determine the relative effects of intraperitoneal or central intravenous access relative to any other parenteral access method. There are several different ways of achieving parenteral access in patients who are unable meet their fluid requirements with oral intake alone. The quality of the evidence, as assessed using the GRADE criteria, is somewhat limited because of the lack of adequately powered trials at low risk of bias. However, we believe that there is sufficient evidence to draw the following conclusions: if peripheral intravenous access can be achieved easily, this allows infusion of larger volumes of fluid than other routes; but if this is not possible, the intraosseous and subcutaneous routes are viable alternatives. The subcutaneous route may be suitable for patients who are not severely dehydrated but in whom ongoing fluid losses cannot be met by oral intake.A film to accompany this review can be viewed here (http://youtu.be/ArVPzkf93ng).

Use of epoetin and darbepoetin in patients with cancer: 2007 American Society of Clinical Oncology/American Society of Hematology clinical practice guideline update.

PubMed

Rizzo, J Douglas; Somerfield, Mark R; Hagerty, Karen L; Seidenfeld, Jerome; Bohlius, Julia; Bennett, Charles L; Cella, David F; Djulbegovic, Benjamin; Goode, Matthew J; Jakubowski, Ann A; Rarick, Mark U; Regan, David H; Lichtin, Alan E

2008-01-01

To update the American Society of Clinical Oncology/American Society of Hematology (ASCO/ASH) recommendations for the use of epoetin. The guideline was expanded to address use of darbepoetin and thromboembolic risk associated with these agents. An Update Committee ("Committee") reviewed and analyzed data published since 2002 through July 2007. MEDLINE and the Cochrane Collaboration Library databases were searched. For patients with chemotherapy-associated anemia, the Committee continues to recommend initiating an erythropoiesis-stimulating agent (ESA) as hemoglobin (Hb) approaches, or falls below, 10 g/dL, to increase Hb and decrease transfusions. ESA treatment continues to be recommended for patients with low-risk myelodysplasia for similar reasons. There is no evidence showing increased survival as a result of ESA treatment. Conclusive evidence is lacking that, absent clinical circumstances necessitating earlier treatment, initiating ESAs at Hb levels greater than 10 g/dL either spares more patients from transfusion or substantially improves their quality of life. Starting doses and dose modifications based on response or lack thereof should follow the package insert. Continuing ESAs beyond 6 to 8 weeks in the absence of response, assuming appropriate dose increase has been attempted in nonresponders as per US Food and Drug Administration-approved labeling, does not seem to be beneficial, and ESA therapy should be discontinued. The Committee recommends monitoring iron stores and supplementing iron intake for ESA-treated patients. ESAs should be used cautiously with chemotherapy, or in clinical states, associated with elevated risk for thromboembolic complications. The Committee also cautions against ESA use for patients with cancer who are not receiving chemotherapy, since recent trials report increased thromboembolic risks and decreased survival under these circumstances.

Use of epoetin and darbepoetin in patients with cancer: 2007 American Society of Hematology/American Society of Clinical Oncology clinical practice guideline update.

PubMed

Rizzo, J Douglas; Somerfield, Mark R; Hagerty, Karen L; Seidenfeld, Jerome; Bohlius, Julia; Bennett, Charles L; Cella, David F; Djulbegovic, Benjamin; Goode, Matthew J; Jakubowski, Ann A; Rarick, Mark U; Regan, David H; Lichtin, Alan E

2008-01-01

To update the American Society of Clinical Oncology/American Society of Hematology (ASCO/ASH) recommendations for the use of epoetin. The guideline was expanded to address use of darbepoetin and thromboembolic risk associated with these agents. An Update Committee ("Committee") reviewed and analyzed data published since 2002 through July 2007. MEDLINE and the Cochrane Collaboration Library databases were searched. For patients with chemotherapy-associated anemia, the Committee continues to recommend initiating an erythropoiesis-stimulating agent (ESA) as hemoglobin (Hb) approaches, or falls below, 10 g/dL, to increase Hb and decrease transfusions. ESA treatment continues to be recommended for patients with low-risk myelodysplasia for similar reasons. There is no evidence showing increased survival as a result of ESA treatment. Conclusive evidence is lacking that, absent clinical circumstances necessitating earlier treatment, initiating ESAs at Hb levels greater than 10 g/dL either spares more patients from transfusion or substantially improves their quality of life. Starting doses and dose modifications based on response or lack thereof should follow the package insert. Continuing ESAs beyond 6 to 8 weeks in the absence of response, assuming appropriate dose increase has been attempted in nonresponders as per US Food and Drug Administration-approved label, does not seem to be beneficial, and ESA therapy should be discontinued. The Committee recommends monitoring iron stores and supplementing iron intake for ESA-treated patients. ESAs should be used cautiously with chemotherapy, or in clinical states, associated with elevated risk for thromo-embolic complications. The Committee also cautions against ESA use for patients with cancer who are not receiving chemotherapy, since recent trials report increased thromboembolic risks and decreased survival under these circumstances.

Febuxostat in the management of gout: a cost-effectiveness analysis.

PubMed

Smolen, Lee J; Gahn, James C; Mitri, Ghaith; Shiozawa, Aki

2016-01-01

To determine the cost-effectiveness of febuxostat vs allopurinol for the management of gout. A stochastic microsimulation cost-effectiveness model with a US private-payer perspective and 5-year time horizon was developed. Model flow based on guideline and real-world treatment paradigms incorporated gout flare, serum uric acid (sUA) testing, treatment titration, discontinuation, and adverse events, chronic kidney disease (CKD) incidence and progression, and type 2 diabetes mellitus (T2DM) incidence. Outcomes were estimated for the general gout population and for gout patients with CKD stages 3/4. Modeled treatment interventions were daily oral febuxostat 40-80 mg and allopurinol 100-300 mg. Baseline patient characteristics were taken from epidemiologic studies, efficacy data from randomized controlled trials, adverse event rates from package inserts, and costs from the literature, government sources, and expert opinion. Eight clinically-relevant incremental cost-effectiveness ratios were estimated: per patient reaching target sUA, per flare avoided, per CKD incidence, progression, stages 3/4 progression, and stage 5 progression avoided, per incident T2DM avoided, and per death avoided. Five-year incremental cost-effectiveness ratios for the general gout population were $5377 per patient reaching target sUA, $1773 per flare avoided, $221,795 per incident CKD avoided, $29,063 per CKD progression avoided, $36,018 per progression to CKD 3/4 avoided, $71,426 per progression to CKD 5 avoided, $214,277 per incident T2DM avoided, and $217,971 per death avoided. In patients with CKD 3/4, febuxostat dominated allopurinol for all cost-effectiveness outcome measures. Febuxostat may be a cost-effective alternative to allopurinol, especially for patients with CKD stages 3 or 4.

14 French pigtail catheters placed by surgeons to drain blood on trauma patients: is 14-Fr too small?

PubMed

Kulvatunyou, Narong; Joseph, Bellal; Friese, Randall S; Green, Donald; Gries, Lynn; O'Keeffe, Terence; Tang, Andy L; Wynne, Julie L; Rhee, Peter

2012-12-01

Small 14F pigtail catheters (PCs) have been shown to drain air quite well in patients with traumatic pneumothorax (PTX). But their effectiveness in draining blood in patients with traumatic hemothorax (HTX) or hemopneumothorax (HPTX) is unknown. We hypothesized that 14F PCs can drain blood as well as large-bore 32F to 40F chest tubes. We herein report our early case series experience with PCs in the management of traumatic HTX and HPTX. We prospectively collected data on all bedside-inserted PCs in patients with traumatic HTX or HPTX during a 30-month period (July 2009 through December 2011) at our Level I trauma center. We then compared our PC prospective data with our trauma registry-derived retrospective chest tube data (January 2008 through December 2010) at our center. Our primary outcome of interest was the initial drainage output. Our secondary outcomes were tube duration, insertion-related complications, and failure rate. For our statistical analysis, we used the unpaired Student's t-test, χ test, and Wilcoxon rank-sum test; we defined significance by a value of p < 0.05. A total of 36 patients received PCs, and 191 received chest tubes. Our PC group had a higher rate of blunt mechanism injuries than our chest tube group did (83 vs. 62%; p = 0.01). The mean initial output was similar between our PC group (560 ± 81 mL) and our chest tube group (426 ± 37 mL) (p = 0.13). In the PC group, the tube was inserted later (median, Day 1; interquartile range, Days 0-3) than the tube inserted in our chest tube group (median, Day 0; interquartile range, Days 0-0) (p < 0.001). Tube duration, rate of insertion-related complications, and failure rate were all similar. In our early experience, 14F PCs seemed to drain blood as well as large-bore chest tubes based on initial drainage output and other outcomes studied. In this early phase, we were being selective in inserting PCs in only stable blunt trauma patients, and PCs were inserted at a later day from the time of the initial evaluation. In the future, we will need a larger sample size and possibly a well-designed prospective study. Therapeutic study, level V.

Diagnostic evaluation of three cardiac software packages using a consecutive group of patients

PubMed Central

2011-01-01

Purpose The aim of this study was to compare the diagnostic performance of the three software packages 4DMSPECT (4DM), Emory Cardiac Toolbox (ECTb), and Cedars Quantitative Perfusion SPECT (QPS) for quantification of myocardial perfusion scintigram (MPS) using a large group of consecutive patients. Methods We studied 1,052 consecutive patients who underwent 2-day stress/rest 99mTc-sestamibi MPS studies. The reference/gold-standard classifications for the MPS studies were obtained from three physicians, with more than 25 years each of experience in nuclear cardiology, who re-evaluated all MPS images. Automatic processing was carried out using 4DM, ECTb, and QPS software packages. Total stress defect extent (TDE) and summed stress score (SSS) based on a 17-segment model were obtained from the software packages. Receiver-operating characteristic (ROC) analysis was performed. Results A total of 734 patients were classified as normal and the remaining 318 were classified as having infarction and/or ischemia. The performance of the software packages calculated as the area under the SSS ROC curve were 0.87 for 4DM, 0.80 for QPS, and 0.76 for ECTb (QPS vs. ECTb p = 0.03; other differences p < 0.0001). The area under the TDE ROC curve were 0.87 for 4DM, 0.82 for QPS, and 0.76 for ECTb (QPS vs. ECTb p = 0.0005; other differences p < 0.0001). Conclusion There are considerable differences in performance between the three software packages with 4DM showing the best performance and ECTb the worst. These differences in performance should be taken in consideration when software packages are used in clinical routine or in clinical studies. PMID:22214226

Blind urethral catheterization in trauma patients suffering from lower urinary tract injuries.

PubMed

Shlamovitz, Gil Z; McCullough, Lynne

2007-02-01

The goals of our study were to review all cases of urethral and bladder trauma that presented to the University of California, Los Angeles (UCLA) Medical Center between January 1998 and August 2005 and determine (1) the clinical characteristics of patients with urethral and/or bladder injuries as well as the sensitivities of those clinical characteristics; (2) whether or not a blind attempt to insert a urethral catheter was performed; and (3) whether there is any evidence that a blind attempt to insert a urethral catheter worsened the initial urinary tract injury. This is a retrospective chart review. The study cohort comprised 46 patients with a mean age of 30 years, including 36 men (78.2%) and 10 women (21.8%). Bladder tears were found in 33 patients, 10 patients had urethral lacerations, and 3 patients had combined bladder and urethral lacerations. The most sensitive finding for urinary bladder or urethral injury was the presence of gross hematuria in the urethral catheter (100%, 95% confidence interval [CI] 0.63-0.89). Blinded insertion of a urethral catheter was attempted in 30 (90.9%, 95% CI 0.75-0.98) patients who suffered from urinary bladder injury, 6 (50%, 95% CI 0.26-0.87) patients who suffered from urethral injury and 1 (33%, 95% CI 0.0-0.9) patient who suffered from a combined urinary bladder and urethral injuries. We did not find evidence that a blind attempt to insert a urethral catheter worsened the initial urinary injury. Gross hematuria in the urethral catheter was the most sensitive sign for the presence of a urethral or urinary bladder injury in our study cohort, and often the only sign of such an injury. We found no evidence that a blind attempt to insert a urethral catheter in patients suffering from urethral and or urinary bladder injuries worsened the initial injury. Larger studies will be needed to determine the safety of blind urethral catheterization in patients that are suspected to suffer from a lower urological trauma. It is our opinion that the current guidelines should be revised to better reflect the current knowledge, technologies, and clinical practice.

Use of Electronic Tablets for Patient Education on Flushing Peripherally Inserted Central Catheters.

PubMed

Petroulias, Patricia L

The purpose of this study was to examine the efficacy of using an electronic tablet to provide patient education for flushing peripherally inserted central catheters (PICCs) as a way to reduce the incidence of occlusion. Eleven patients, newly diagnosed with cancer, participated in a pilot study that used a video on PICC flushing and remote coaching using FaceTime (Apple, Cupertino, CA) to teach patients how to maintain their PICCs in their homes. At the end of the 6-week intervention, no adverse outcomes (occlusions or infections) were noted among the patients who participated in the study.

Pedicle Screw Insertion Accuracy Using O-Arm, Robotic Guidance, or Freehand Technique: A Comparative Study.

PubMed

Laudato, Pietro Aniello; Pierzchala, Katarzyna; Schizas, Constantin

2018-03-15

A retrospective radiological study. The aim of this study was to evaluate the accuracy of pedicle screw insertion using O-Arm navigation, robotic assistance, or a freehand fluoroscopic technique. Pedicle screw insertion using either "O-Arm" navigation or robotic devices is gaining popularity. Although several studies are available evaluating each of those techniques separately, no direct comparison has been attempted. Eighty-four patients undergoing implantation of 569 lumbar and thoracic screws were divided into three groups. Eleven patients (64 screws) had screws inserted using robotic assistance, 25 patients (191 screws) using the O-arm, while 48 patients (314 screws) had screws inserted using lateral fluoroscopy in a freehand technique. A single experienced spine surgeon assisted by a spinal fellow performed all procedures. Screw placement accuracy was assessed by two independent observers on postoperative computed tomography (CTs) according to the A to D Rampersaud criteria. No statistically significant difference was noted between the three groups. About 70.4% of screws in the freehand group, 69.6% in the O arm group, and 78.8% in the robotic group were placed completely within the pedicle margins (grade A) (P > 0.05). About 6.4% of screws were considered misplaced (grades C&D) in the freehand group, 4.2% in the O-arm group, and 4.7% in the robotic group (P > 0.05). The spinal fellow inserted screws with the same accuracy as the senior surgeon (P > 0.05). The advent of new technologies does not appear to alter accuracy of screw placement in our setting. Under supervision, spinal fellows might perform equally well to experienced surgeons using new tools. The lack of difference in accuracy does not imply that the above-mentioned techniques have no added advantages. Other issues, such as surgeon/patient radiation, fiddle factor, teaching suitability, etc., outside the scope of our present study, need further assessment. 3.

Perforation of the urinary bladder caused by transurethral insertion of a pencil for the purpose of masturbation in a 29-year-old female.

PubMed

Bantis, Athanasios; Sountoulides, Petros; Kalaitzis, Christos; Giannakopoulos, Stelios; Agelonidou, Eleni; Foutzitzi, Soultana; Touloupidis, Stavros

2010-01-01

The urethra is a usual site of introduction of foreign bodies for autoerotic stimulation. We present an unusual case of bladder perforation caused by foreign body that was self-inserted in the urethra and consequently slipped inside the bladder in a 29-year-old female patient with psychiatric disease. The patient was referred to our department for macroscopic hematuria and abdominal pain. Imaging studies revealed the presence of a foreign body in the pelvic area which had perforated the left lateral wall of the bladder. The foreign body was removed via open cystotomy. In psychiatric patients hematuria and pelvic pain may result from insertion of a foreign body in the bladder usually during masturbation.

Perforation of the Urinary Bladder Caused by Transurethral Insertion of a Pencil for the Purpose of Masturbation in a 29-Year-Old Female

PubMed Central

Bantis, Athanasios; Sountoulides, Petros; Kalaitzis, Christos; Giannakopoulos, Stelios; Agelonidou, Eleni; Foutzitzi, Soultana; Touloupidis, Stavros

2010-01-01

The urethra is a usual site of introduction of foreign bodies for autoerotic stimulation. We present an unusual case of bladder perforation caused by foreign body that was self-inserted in the urethra and consequently slipped inside the bladder in a 29-year-old female patient with psychiatric disease. The patient was referred to our department for macroscopic hematuria and abdominal pain. Imaging studies revealed the presence of a foreign body in the pelvic area which had perforated the left lateral wall of the bladder. The foreign body was removed via open cystotomy. In psychiatric patients hematuria and pelvic pain may result from insertion of a foreign body in the bladder usually during masturbation. PMID:20862362

Remote down-hole well telemetry

DOEpatents

Briles, Scott D [Los Alamos, NM; Neagley, Daniel L [Albuquerque, NM; Coates, Don M [Santa Fe, NM; Freund, Samuel M [Los Alamos, NM

2004-07-20

The present invention includes an apparatus and method for telemetry communication with oil-well monitoring and recording instruments located in the vicinity of the bottom of gas or oil recovery pipes. Such instruments are currently monitored using electrical cabling that is inserted into the pipes; cabling has a short life in this environment, and requires periodic replacement with the concomitant, costly shutdown of the well. Modulated reflectance, a wireless communication method that does not require signal transmission power from the telemetry package will provide a long-lived and reliable way to monitor down-hole conditions. Normal wireless technology is not practical since batteries and capacitors have to frequently be replaced or recharged, again with the well being removed from service. RF energy generated above ground can also be received, converted and stored down-hole without the use of wires, for actuating down-hole valves, as one example. Although modulated reflectance reduces or eliminates the loss of energy at the sensor package because energy is not consumed, during the transmission process, additional stored extra energy down-hole is needed.

Are condom instructions readable? Results of a readability study.

PubMed Central

Richwald, G A; Wamsley, M A; Coulson, A H; Morisky, D E

1988-01-01

The use of condoms has assumed a central position in the current strategy to prevent sexual transmission of the human immunodeficiency virus. The effectiveness of condoms in disease prophylaxis is dependent, to a degree, on their correct use. Condom manufacturers routinely include information on condom use either printed on the actual package or in an enclosed package insert. With the use of three readability formulas, the reading grade level was determined for 14 different sets of instructions included with 25 brands of condoms manufactured by 7 domestic and 1 overseas manufacturer. The readability formulas, when applied to instructions for condom use, estimated that, conservatively, 8 of the 14 instructions required at least reading at the level of a high school graduate and none required less than a 10th grade level. Clearly written instructions and simple concepts could assist current and future condom users in the correct use of condoms and improve the effectiveness of condoms in the prevention of AIDS and other sexually transmitted diseases. PMID:3136494

Variable Depth Bragg Peak Method for Single Event Effects Testing

NASA Technical Reports Server (NTRS)

Buchner, S.; Kanyogoro, N.; Foster, C.; O'Neill, P.

2011-01-01

Traditionally, accelerator SEE testing is accomplished by removing the tops of packages so that the IC chips are accessible to heavy ions. However, ICs in some advanced packages cannot be de-lidded so a different approach is used that involves grinding and/or chemically etching away part of the package and the chip from the back side. The parts are then tested from the back side with ions having sufficient range to reach the sensitive volume. More recently, the entire silicon substrate in an SOI/SRAM was removed, making it possible to use low-energy ions with shorter ranges. Where removal of part of the package is not possible, facilities at Michigan State, NASA Space Radiation Laboratory, GANIL (France) and GSI (Germany) offer high-energy heavy ions with long ranges so that the ions can reach the devices' sensitive volumes without much change in the LET. Unfortunately, a run will typically involve only one ion species having a single energy and LET due to the long time it takes to tune a new energy. The Variable Depth Bragg Peak (VDBP) method is similar to the above method in that it involves the use of high-energy heavy ions that are able to pass through the packaging material and reach the device, obviating the need to remove the package. However, the method provides a broad range of LETs from a single ion by inserting degraders in the beam that modify the ion energy and, therefore, the LET. The crux of the method involves establishing a fiduciary point for degrader thickness, i.e., where the Bragg peak is located precisely at the sensitive volume in the device, for which the measured SEU cross-section and the ion LET are both also maxima and can be calculated using a Monte-Carlo program, TRIM. Once the fiduciary point has been established, calibrated high density polyethylene (HDPE) degraders are inserted into or removed from the beam to vary the ion LET at the device in a known manner. After each change of degrader thickness, the SEU cross-section is measured and the corresponding LET calculated from the change in degrader thickness. That information is used to generate a plot of cross-section as a function of ion LET. The advantages of this approach are that the part does not have to be de-lidded and a broad range of LETs is available from a single heavy ion without having to go to non-normal angles of incidence to change the "effective" LET. As we will show, it is possible to obtain an entire curve of cross-section versus LET using just two or three ions. Fig. 1 shows curves of cross-section vs LET for a Freescale 4 Mbit SOI/SRAM measured at the 88" Cyclotron at Berkeley and at NSRL. The open symbols are the data obtained from Berkeley for top-side and back-side irradiation. The solid data points are for the data obtained at NSRL using a device for which the package was intact. The data are for Iron and Gold and cover a range of LETs from 4 MeV.cm2/mg to 84 MeV.cm2/mg. The agreement between the data obtained from Berkeley and from NSRL is excellent, demonstrating that the VDBP method is capable of providing accurate values of cross-section versus LET, at least for the 4 Mbit SRAM. Details of the technique will be included in the final presentation.

The effect of gait training with shoe inserts on the improvement of pain and gait in sacroiliac joint patients.

PubMed

Cho, Byung-Yun; Yoon, Jung-Gyu

2015-08-01

[Purpose] The purpose of the current research was to identify how gait training with shoe inserts affects the pain and gait of sacroiliac joint dysfunction patients. [Subjects and Methods] Thirty subjects were randomly selected and assigned to be either the experimental group (gait training with shoe insert group) or control group. Each group consisted of 15 patients. Pain was measured by Visual Analogue Scale, and foot pressure in a standing position and during gait was measured with a Gateview AFA-50 system (Alpus, Seoul, Republic of Korea). A paired sample t-test was used to compare the pain and gait of the sacroiliac joint before and after the intervention. Correlation between pain and walking after gait training with shoe inserts was examined by Pearson test. The level of significance was set at α=0.05. [Results] It was found that application of the intervention to the experimental group resulted in a significant decrease in sacroiliac joint pain. It was also found that there was a significant correlation between Visual Analogue Scale score and dynamic asymmetric index (r= 0.796) and that there was a negative correlation between Visual Analogue Scale score and forefoot/rear foot peak pressure ratio (r=-0.728). [Conclusion] The results of our analysis lead us to conclude that the intervention with shoe inserts had a significant influence on the pain and gait of sacroiliac joint patients.

The effect of gait training with shoe inserts on the improvement of pain and gait in sacroiliac joint patients

PubMed Central

Cho, Byung-Yun; Yoon, Jung-Gyu

2015-01-01

[Purpose] The purpose of the current research was to identify how gait training with shoe inserts affects the pain and gait of sacroiliac joint dysfunction patients. [Subjects and Methods] Thirty subjects were randomly selected and assigned to be either the experimental group (gait training with shoe insert group) or control group. Each group consisted of 15 patients. Pain was measured by Visual Analogue Scale, and foot pressure in a standing position and during gait was measured with a Gateview AFA-50 system (Alpus, Seoul, Republic of Korea). A paired sample t-test was used to compare the pain and gait of the sacroiliac joint before and after the intervention. Correlation between pain and walking after gait training with shoe inserts was examined by Pearson test. The level of significance was set at α=0.05. [Results] It was found that application of the intervention to the experimental group resulted in a significant decrease in sacroiliac joint pain. It was also found that there was a significant correlation between Visual Analogue Scale score and dynamic asymmetric index (r= 0.796) and that there was a negative correlation between Visual Analogue Scale score and forefoot/rear foot peak pressure ratio (r=-0.728). [Conclusion] The results of our analysis lead us to conclude that the intervention with shoe inserts had a significant influence on the pain and gait of sacroiliac joint patients. PMID:26357428

Development and evaluation of a centralised computerised registry for ureteric stents: completing the audit cycle.

PubMed

Davis, N F; Murray, G; O'Connor, T; Browne, C; MacCraith, E; Galvin, D; Mulvin, D; Quinlan, D; Lennon, G

2017-11-01

A forgotten ureteric stent may result in severe renal impairment leading to nephrectomy. To compare the effectiveness of a centralised computerised registry for monitoring ureteric stent activity with a previously established theatre stent logbook system. This prospective audit was performed in two 9-monthly intervals. During the first interval, insertion/removal of a ureteric stent was documented in a specific theatre stent logbook. In the second interval, an electronic centralised computerised registry was developed to document insertion/removal of a ureteric stent onto an accessible hospital server. A computerised traffic-light system was also developed to identify patients with an indwelling stent for >3 months. The primary outcome variable was the number of prolonged indwelling ureteric stents in both groups. During the first time interval, 188 ureteric stents were inserted and 182 (96%) were removed or changed. Six (4%) patients underwent insertion of a ureteric stent for a prolonged period of time (>6 months). This subgroup required complex endourological intervention for stent removal due to encrustation. During the second time interval, 157 ureteric stents were inserted and all patients had their stent removed or changed within 6 months. No patients in this group were lost to follow-up. This study demonstrates that a centralised computerised ureteric stent registry is superior to a conventional logbook for monitoring ureteric stent activity. We propose the introduction a centralised nationalised ureteric stent registry for eliminating the potential for prolonged or forgotten ureteric stents.

Risks of Preterm Premature Rupture of Membranes and Preterm Birth Post Fetoscopy Based on Location of Trocar Insertion Site.

PubMed

Chmait, Ramen H; Chon, Andrew H; Korst, Lisa M; Llanes, Arlyn; Kontopoulos, Eftichia V; Quintero, Ruben A

2018-07-01

 The objective of this study was to assess whether the location of the trocar insertion site for laser treatment of twin-twin transfusion syndrome was associated with preterm-premature rupture of membranes (PPROM) and preterm birth (PTB).  In this study trocar location was documented in the operating room. Lower uterine segment (LUS) location was defined as any insertion <10 cm vertically from the pubic symphysis. Lateral location was defined as ≥5 cm horizontally from the midline. Patient characteristics were tested against three outcomes: PPROM ≤ 21 days postoperative, PTB < 28 weeks, and PTB < 32 weeks. For each outcome, multiple logistic models were fitted to examine the effect of trocar location, controlling for potential risk factors.  A total of 743 patients were studied. Patients with LUS location were twice as likely as those with a more superior location to have PPROM ≤ 21 days (OR = 2.33, 1.12-4.83, p  = 0.0236). Patients with both a LUS and Lateral location were over six times more likely to have PPROM ≤ 21 days (OR = 6.66, 2.36-18.78, p  = 0.0003). Trocar insertion site was not associated with PTB.  We found that trocar insertion in the LUS, particularly the lateral LUS, was associated with an increased risk of PPROM. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Occurrence of Phlebitis: A Systematic Review and Meta-analysis.

PubMed

Chang, Wen P; Peng, Yu X

Peripheral venous catheters (PVCs) are commonly used in clinical practice. However, varying degrees of phlebitis often occur in patients receiving intravenous injections. The relevant literature suggests that phlebitis occurrence is highly associated with the catheter gauge, insertion site, and catheterization duration. Nevertheless, no meta-analysis has been performed on the influence of these three factors on the occurrence of phlebitis. The objective of this study was to determine whether any significant differences exist in the occurrence of phlebitis between catheters of 20 gauge or smaller and those larger than 20 gauge, between catheters inserted in the antecubital fossa and those inserted in other locations on the upper limbs, or between catheters inserted for more than 96 hours and those inserted for 96 hours or less. Using a systematic approach, we searched for literature published between 2006 and 2017 in the Cumulative Index to Nursing and Allied Health Literature (CINAHL), PubMed, ProQuest, and Cochrane Library databases. We used Comprehensive Meta-analysis Version 2 to perform our meta-analysis. After the screening and review processes, we identified 17 studies that met our selection conditions. Among these studies, 14 contained complete data for meta-analysis. These studies involved 4,343 patients and 5,846 PVCs. Regarding the overall effect size in the meta-analysis, the results of the forest plot comparing catheters of 20 gauge or smaller and those larger than 20 gauge presented a risk ratio (RR) of 0.88 (95% confidence interval [0.67, 1.17], p = .380), indicating no statistically significant difference in the occurrence of phlebitis between catheters of the aforementioned gauges. The results of the forest plot comparing catheters inserted in the antecubital fossa and those inserted in other locations on the upper limbs presented an RR of 1.05 (95% confidence interval [0.82, 1.34], p = .696), indicating no statistically significant difference in the occurrence of phlebitis between catheters inserted in the aforementioned locations. The results of the forest plot comparing catheters inserted for more than 96 hours and those inserted for 96 hours or less presented an RR of 1.13 (95% confidence interval [0.49, 2.61], p = .779), indicating no statistically significant difference in the occurrence of phlebitis between catheters inserted for the aforementioned durations. The empirical results of this meta-analysis can serve as a reference for hospital management for selecting the PVC gauge, insertion site, and catheterization duration. In addition to the three factors that we analyzed, whether any other factors influence the occurrence of phlebitis in patients with catheter implantation is worth investigating in future research.

SU-E-J-226: Efficient Use of Computed Tomography (CT) and Magnetic Resonance Imaging (MRI) for Cervical-Cancer Brachytherapy

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

Damato, A; Bhagwat, M; Buzurovic, I

Purpose: To investigate image modality selection in an environment with limited access to interventional MRI for image-guided high-dose-rate cervical-cancer brachytherapy. Methods: Records of all cervical-cancer patients treated with brachytherapy between 1/2013 and 8/2014 were analyzed. Insertions were performed under CT guidance (CT group) or with >1 fraction under 3T MR guidance (MRI group; subMRI includes only patients who also had a CT-guided insertion). Differences between groups in clinical target volume (CTV), disease stage (I/II or III/IV), number of patients with or without interstitial needles, and CTV D90 were investigated. Statistical significance was evaluated with the Student T test and Fishermore » test (p <0.05). Results: 46 cervical-cancer patients were included (16 MRI [3 subMRI], 30 CT). CTV: overall, 55±53 cm3; MRI, 81±61 cm3; CT, 42±44 cm3 (p = 0.017). Stage: overall, 24 I/II and 22 III/IV; MRI, 3 I/II and 13 III/IV; CT, 21 I/II and 9 III/IV (p = 0.002). Use of needles: overall, 26 without and 20 with; MRI, 5 without and 11 with; CT, 21 without and 9 with (p = 0.015). CTV D90: overall, 82±5 Gy; MRI, 81±6 Gy; CT, 82±5 Gy (p = 0.78). SubMRI: CTV and D90 (as % of nominal fraction dose) were 23±6 cm3 and 124±3% for MRI-guided insertions and 21±5 cm3 (p = 0.83) and 106±12% (p = 0.15) for CT-guided insertions. Conclusion: Statistically significant differences in patient population indicate preferential use of MRI for patients with high-stage disease and large residual CTVs requiring the use of interstitial needles. CTV D90 was similar between groups, despite the difference in patient selection. For patients who underwent both CT and MRI insertions, a larger MR CTV D90 and similar CTVs between insertions were observed. While MRI is generally preferable to CT, MRI selection can be optimized in environments without a dedicated MRI brachytherapy suite. This work was partially funded by the NIH R21 CA167800 (PI: Viswanathan; aviswanathan@partners.org)« less

Trends in Penile Prosthetics: Influence of Patient Demographics, Surgeon Volume, and Hospital Volume on Type of Penile Prosthesis Inserted in New York State.

PubMed

Kashanian, James A; Golan, Ron; Sun, Tianyi; Patel, Neal A; Lipsky, Michael J; Stahl, Peter J; Sedrakyan, Art

2018-02-01

Penile prostheses (PPs) are a discrete, well-tolerated treatment option for men with medical refractory erectile dysfunction. Despite the increasing prevalence of erectile dysfunction, multiple series evaluating inpatient data have found a decrease in the frequency of PP surgery during the past decade. To investigate trends in PP surgery and factors affecting the choice of different PPs in New York State. This study used the New York State Department of Health Statewide Planning and Research Cooperative (SPARCS) data cohort that includes longitudinal information on hospital discharges, ambulatory surgery, emergency department visits, and outpatient services. Patients older than 18 years who underwent inflatable or non-inflatable PP insertion from 2000 to 2014 were included in the study. Influence of patient demographics, surgeon volume, and hospital volume on type of PP inserted. Since 2000, 14,114 patients received PP surgery in New York State; 12,352 PPs (88%) were inflatable and 1,762 (12%) were non-inflatable, with facility-level variation from 0% to 100%. There was an increasing trend in the number of annual procedures performed, with rates of non-inflatable PP insertion decreasing annually (P < .01). More procedures were performed in the ambulatory setting over time (P < .01). Important predictors of device choice were insurance type, year of insertion, hospital and surgeon volume, and the presence of comorbidities. Major influences in choice of PP inserted include racial and socioeconomic factors and surgeon and hospital surgical volume. Use of the SPARCS database, which captures inpatient and outpatient services, allows for more accurate insight into trends in contrast to inpatient sampling alone. However, SPARCS is limited to patients within New York State and the results might not be generalizable to men in other states. Also, patient preference was not accounted for in these analyses, which can play a role in PP selection. During the past 14 years, there has been an increasing trend in inflatable PP surgery for the management of erectile dysfunction. Most procedures are performed in the ambulatory setting and not previously captured by prior studies using inpatient data. Kashanian JA, Golan R, Sun T, et al. Trends in Penile Prosthetics: Influence of Patient Demographics, Surgeon Volume, and Hospital Volume on Type of Penile Prosthesis Inserted in New York State. J Sex Med 2018;15:245-250. Copyright © 2017 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.

Techniques for the insertion of the ProSeal laryngeal mask airway: comparison of the Foley airway stylet tool with the introducer tool in a prospective, randomized study.

PubMed

Chen, Mao-Kai; Hsu, Hung-Te; Lu, I-Cheng; Shih, Chih-Kai; Shen, Ya-Chun; Tseng, Kuang-Yi; Cheng, Kuang-I

2014-01-01

Many tools have been developed to facilitate the insertion of the ProSeal laryngeal mask airway (LMA) insertion, which can be impeded by folding of its soft cuff. The aim of this study was to compare the efficiency of ProSeal LMA insertion guided by a soft, direct optical Foley Airway Stylet Tool (FAST) with the standard introducer tool (IT). One hundred sixty patients undergoing general anesthesia using the ProSeal LMA as an airway management device were randomly allocated to either FAST-guided or IT-assisted groups. Following ProSeal LMA insertion, the glottic and esophageal openings were identified using a fiberoptic bronchoscope introduced through the airway and the drain tube. The primary outcomes were time taken to insert the ProSeal LMA and the success rate at the first attempt. Secondary end points included ease of insertion, hemodynamic response to insertion, and postoperative adverse events recorded in the recovery room and on the first postoperative morning. One hundred forty patients were included in the final analysis: 66 in the FAST-guided group and 74 in the IT-assisted group. The success rate of FAST device-guided ProSeal LMA insertion (95.7%) was broadly comparable with IT-assisted insertion (98.7%). However, the time taken to insert the ProSeal LMA was significantly longer when the FAST technique was used (p <0.001). The incidence of correct alignment of the airway tube and the drain tube did not differ significantly between the groups. There were no significant differences in ease of insertion or hemodynamic responses to insertion, except that the incidence of postoperative sore throat was significantly higher in the FAST group on the first postoperative day (22.2% compared with 6.8% in the IT group; p = 0.035). Both FAST-guided and IT-assisted techniques achieved correct ProSeal LMA positioning, but the IT technique was significantly quicker and less likely to cause a sore throat. ClinicalTrials.gov Identifier: NCT02048657.

Quality assurance: recommended guidelines for safe heating by capacitive-type heating technique to treat patients with metallic implants.

PubMed

Kato, Hirokazu; Kondo, Motoharu; Imada, Hajime; Kuroda, Masahiro; Kamimura, Yoshitsugu; Saito, Kazuyuki; Kuroda, Kagayaki; Ito, Koichi; Takahashi, Hideaki; Matsuki, Hidetoshi

2013-05-01

This article is a redissemination of the previous Japanese Quality Assurance Guide guidelines. Specific absorption rate and temperature distribution were investigated with respect to various aspects including metallic implant size and shape, insertion site, insertion direction, blood flow and heating power, and simulated results were compared with adverse reactions of patients treated by radio frequency capacitive-type heating. Recommended guidelines for safe heating methods for patients with metallic implants are presented based on our findings.

Pancreatic stent insertion after an unintentional guidewire cannulation of the pancreatic duct during ERCP.

PubMed

García-Cano, Jesús; Viñuelas Chicano, Miriam; Del Moral Martínez, María; Muñiz Muñoz, Marta; Murillo Matamoros, Claudio; Suárez Matías, Miguel; Valiente González, Laura; Martínez Pérez, Teresa; Martínez Fernández, Raquel; Gómez Ruiz, Carmen Julia; Pérez García, José Ignacio; Morillas Ariño, Julia

2018-04-24

the guidewire (GW) may enter the pancreatic duct during common bile duct (CBD) cannulation attempts in endoscopic retrograde cholangiopancreatography (ERCP). After GW passage into the pancreas, the most effective maneuver for CBD cannulation and pancreatitis prevention has not been determined. to study CBD cannulation and post-ERCP pancreatitis rates when a pancreatic stent is inserted after an unintentional GW cannulation of the pancreatic duct. a retrospective analysis of patients undergoing ERCP for biliary drainage that were included prospectively into a database. After unintentional GW cannulation of the pancreatic duct, a straight 5-Fr and 4-cm long plastic stent was inserted. The stents had no internal flaps to facilitate expulsion. CBD cannulation attempts were made above the stent. A pancreatic sphincterotomy was performed in patients older than 60 years before stent insertion. a total of 46 pancreatic stents were inserted during 154 ERCP (29.8%) procedures. In the stent group, CBD cannulation was accomplished in 44/46 (95.6%) subjects. A total of 21/46 (45.6%) pancreatic sphincterotomies were performed. Only 1/46 (2.17%) mild pancreatitis cases were observed and most stents were spontaneously expelled. in this study, the CBD was eventually reached with the insertion of a plastic pancreatic stent after an unintentional GW passage into the pancreatic duct while attempting a CBD cannulation. No adverse events were observed following pancreatic stent insertion.

Patient satisfaction and masticatory efficiency of single implant-retained mandibular overdentures using the stud and magnetic attachments.

PubMed

Cheng, Tao; Sun, Guifeng; Huo, Jingyu; He, Xiaoji; Wang, Yining; Ren, Yan-Fang

2012-11-01

To study patient satisfaction and masticatory efficiency of single implant-retained mandibular overdentures using the stud and magnetic attachments in a randomized clinical trial with a crossover design. Patients received a single implant placed in the midline of the mandible and either a stud (Locator) or a magnetic (Magfit) attachment, assigned at random. Patient satisfaction, including patient comfort, speech, chewing ability and retention, and masticatory efficiency measured by chewing peanuts, were assessed before and 3 months after attachment insertion. Patient satisfaction and masticatory efficiency were evaluated again 3 months after insertion of the alternate attachment bodies. The outcomes were compared before and after insertion of the attachments and between the two types of attachments using Wilcoxon signed rank tests. Patient overall satisfaction, comfort, speech, chewing ability, and retention improved significantly after insertion of both types of attachment bodies (p<0.05). Masticatory efficiencies also increased in both the Locator and the Magfit groups (p<0.05). There were no statistically significant differences in patient overall satisfaction, comfort, speech, and retention between the two types of attachments (p>0.05). The Locator attachments performed better in perceived chewing ability than the Magfit (p<0.05), but there was no statistically significant difference in masticatory efficiency between the two attachment types (p>0.05). Clinical outcomes were significantly improved in single implant-retained mandibular overdentures using either the Locator or the Magfit magnetic attachments. There was no difference in masticatory efficiency between the two attachment types. Copyright © 2012 Elsevier Ltd. All rights reserved.

Images created in a model eye during simulated cataract surgery can be the basis for images perceived by patients during cataract surgery

PubMed Central

Inoue, M; Uchida, A; Shinoda, K; Taira, Y; Noda, T; Ohnuma, K; Bissen-Miyajima, H; Hirakata, A

2014-01-01

Purpose To evaluate the images created in a model eye during simulated cataract surgery. Patients and methods This study was conducted as a laboratory investigation and interventional case series. An artificial opaque lens, a clear intraocular lens (IOL), or an irrigation/aspiration (I/A) tip was inserted into the ‘anterior chamber' of a model eye with the frosted posterior surface corresponding to the retina. Video images were recorded of the posterior surface of the model eye from the rear during simulated cataract surgery. The video clips were shown to 20 patients before cataract surgery, and the similarity of their visual perceptions to these images was evaluated postoperatively. Results The images of the moving lens fragments and I/A tip and the insertion of the IOL were seen from the rear. The image through the opaque lens and the IOL without moving objects was the light of the surgical microscope from the rear. However, when the microscope light was turned off after IOL insertion, the images of the microscope and operating room were observed by the room illumination from the rear. Seventy percent of the patients answered that the visual perceptions of moving lens fragments were similar to the video clips and 55% reported similarity with the IOL insertion. Eighty percent of the patients recommended that patients watch the video clip before their scheduled cataract surgery. Conclusions The patients' visual perceptions during cataract surgery can be reproduced in the model eye. Watching the video images preoperatively may help relax the patients during surgery. PMID:24788007

Alternative antiretroviral therapy formulations for patients unable to swallow solid oral dosage forms.

PubMed

Duggan, Joan M; Akpanudo, Barbara; Shukla, Vipul; Gutterson, Glen; Eitniear, Lindsey; Sahloff, Eric G

2015-09-15

Evidence-based guidance is presented to assist clinicians in selecting alternative formulations of antiretroviral (ARV) agents for patients with human immunodeficiency virus (HIV) infection who are unable to swallow tablets or capsules. The inability to take medications in standard oral dosage forms can be associated with nonadherence or the use of alternative administration strategies such as capsule or tablet breaking, crushing, or chewing. Patients with HIV infection require long-term ARV therapy to maintain viral suppression; ARV agents are predominately available as tablets and capsules that may pose swallowing difficulties for some patients. Using a variety of sources (the primary literature, pharmaceutical package inserts, and requests for unpublished data from drug manufacturers), available evidence on the bioavailability of ARV medications after disruption of the capsule or tablet matrix was reviewed; information on alternative formulations of ARV agents was also assessed. With several ARV agents, disruption of the solid oral dosage form by crushing, chewing, or breaking tablets or opening capsules prior to ingestion has been shown to result in altered bioavailability or pharmacokinetics and thus the potential for incomplete virological suppression, increased adverse effects, and suboptimal health outcomes. Of the 33 single-agent ARV medications and combination ARV products in five classes available at the time of review, approximately half exist as powders, liquids, injectables, or chewable or dissolvable tablets. If alternative ARV formulations or administration methods are used, close monitoring for achievement of virological and immunologic success and potential toxicities is recommended. Copyright © 2015 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

Optical isolators for 2-micron fibre lasers

NASA Astrophysics Data System (ADS)

Stevens, Gary; Legg, Thomas H.; Shardlow, Peter

2015-02-01

We report on the development and testing of optical isolators for use in 2-micron fiber laser systems. A variety of potential Faraday rotator materials were characterised to identify the most suitable materials for use in the 1700-2100nm wavelength range. Isolators based on the three best performing materials were then developed and packaged as fiber-in, fiber-out and fiber-in, beam-out devices. The isolators were then tested in CW, pulsed and ultrafast laser systems. The three different designs produced different performance characteristics, but all designs demonstrated isolation >25dB and insertion losses of <1.2 dB.

Visualization Techniques for Assessing Design Factors That Affect the Interaction between Pharmaceutical Vials and Stoppers.

PubMed

Lam, Philippe; Stern, Al

2010-01-01

We developed several techniques for visualizing the fit between a stopper and a vial in the critical flange area, a location typically hidden from view. Using these tools, it is possible to identify surfaces involved in forming the initial seal immediately after stopper insertion. We present examples illustrating important design elements that can contribute to forming a robust primary package. These techniques can also be used for component screening by facilitating the identification of combinations that do not fit well together so that they can be eliminated early in the selection process.

Solar Mesosphere Explorer

NASA Technical Reports Server (NTRS)

1981-01-01

Five experiments and the instruments packages designed for use in studying reactions between sunlight, ozone, and other chemicals in the atmosphere as well as for determining how ozone concentrations are transported in the mesosphere are described. The spin-stabilized satellite carrying the experiments consists of an observatory module and a spacecraft bus. Powered by a solar array which charges the nickel-cadmium batteries, the satellite is to be inserted into a sun synchronous orbit by a two stage Delta 2310 launch vehicle. The mission objectives, spacecraft configurations, and various subsystems are described as well as the ground support and prelaunch operations.

Fiber-optic coupling based on nonimaging expanded-beam optics.

PubMed

Moslehi, B; Ng, J; Kasimoff, I; Jannson, T

1989-12-01

We have fabricated and experimentally tested low-cost and mass-producible multimode fiber-optic couplers and connectors based on nonimaging beam-expanding optics and Liouville's theorem. Analysis indicates that a pair coupling loss of -0.25 dB can be achieved. Experimentally, we measured insertion losses as low as -0.38 dB. The beam expanders can be mass produced owing to the use of plastic injection-molding fabrication techniques and packaged in standard connector housings. This design is compatible with the fiber geometry and can yield highly stable coupling owing to its high tolerance for misalignments.

Blind bedside postpyloric placement of spiral tube as rescue therapy in critically ill patients: a prospective, tricentric, observational study.

PubMed

Lv, Bo; Hu, Linhui; Chen, Lifang; Hu, Bei; Zhang, Yanlin; Ye, Heng; Sun, Cheng; Zhang, Xiunong; Lan, Huilan; Chen, Chunbo

2017-09-26

Various special techniques for blind bedside transpyloric tube placement have been introduced into clinical practice. However, transpyloric spiral tube placement facilitated by a blind bedside method has not yet been reported. The objective of this prospective study was to evaluate the safety and efficiency of blind bedside postpyloric placement of a spiral tube as a rescue therapy subsequent to failed spontaneous transpyloric migration in critically ill patients. This prospective, tricentric, observational study was conducted in the intensive care units (ICUs) of three tertiary hospitals. A total of 127 consecutive patients with failed spontaneous transpyloric spiral tube migration despite using prokinetic agents and still required enteral nutrition for more than 3 days were included. The spiral tube was inserted postpylorically using the blind bedside technique. All patients received metoclopramide intravenously prior to tube insertion. The exact tube tip position was determined by radiography. The primary efficacy endpoint was the success rate of postpyloric spiral tube placement. Secondary efficacy endpoints were success rate of a spiral tube placed in the third portion of the duodenum (D3) or beyond, success rate of placement in the proximal jejunum, time to insertion, length of insertion, and number of attempts. Safety endpoints were metoclopramide-related and major adverse tube-associated events. In 81.9% of patients, the spiral feeding tubes were placed postpylorically; of these, 55.1% were placed in D3 or beyond and 33.9% were placed in the proximal jejunum, with a median time to insertion of 14 min and an average number of attempts of 1.4. The mean length of insertion was 95.6 cm. The adverse event incidence was 26.0%, and no serious adverse event was observed. Blind bedside postpyloric placement of a spiral tube, as a rescue therapy subsequent to failed spontaneous transpyloric migration in critically ill patients, is safe and effective. This technique may facilitate the early initiation of postpyloric feeding in the ICU. Chinese Clinical Trial Registry, ChiCTR-OPN-16008206 . Registered on 1 April 2016.

Characterization and Surgical Management of Achilles Tendon Sleeve Avulsions.

PubMed

Huh, Jeannie; Easley, Mark E; Nunley, James A

2016-06-01

An Achilles sleeve avulsion occurs when the tendon ruptures distally from its calcaneal insertion as a continuous "sleeve." This relatively rare injury pattern may not be appreciated until the time of surgery and can be challenging to treat because, unlike a midsubstance rupture, insufficient tendon remains on the calcaneus to allow for end-to-end repair, and unlike a tuberosity avulsion fracture, any bony element avulsed with the tendon is inadequate for internal fixation. This study aimed to highlight the characteristics of Achilles sleeve avulsions and present the outcomes of operative repair using suture anchor fixation. A retrospective analysis was conducted on 11 consecutive Achilles tendon sleeve avulsions (10 males, 1 female; mean age 44 years) that underwent operative repair between 2008 and 2014. Patient demographics, injury presentation, and operative details were reviewed. Postoperative outcomes were collected at a mean follow-up of 38.4 (range, 12-83.5) months, including the American Orthopaedic Foot & Ankle Society (AOFAS) Ankle-Hindfoot score, visual analog scale (VAS) for pain, plantarflexion strength, patient satisfaction, and complications. Eight patients (72.7%) had preexisting symptoms of insertional Achilles disease. Ten of 11 (90.9%) injuries were sustained during recreational athletic activity. An Achilles sleeve avulsion was recognized preoperatively in 7 of 11 (64%) cases, where lateral ankle radiographs demonstrated a small radiodensity several centimeters proximal to the calcaneal insertion. Intraoperatively, 90.9% of sleeve avulsions had a concomitant Haglund deformity and macroscopic evidence of insertional tendinopathy. All patients healed after suture anchor repair. The average AOFAS score was 92.8 and VAS score was 0.9. Ten patients (90.9%) were completely satisfied. One complication occurred, consisting of delayed wound healing. Achilles tendon sleeve avulsions predominantly occurred in middle-aged men with preexisting insertional disease, while engaged in athletic activity. Suture anchor fixation, combined with addressing concomitant insertional pathology, was a reliable and safe technique for the operative management of Achilles tendon sleeve avulsions. The majority of patients returned to their preinjury levels of work and recreational activity. Level IV, retrospective case series. © The Author(s) 2016.

The psychosocial benefits of secondary hydroxyapatite orbital implant insertion and prosthesis wearing for patients with anophthalmia.

PubMed

Wang, Junming; Zhang, Hong; Chen, Wei; Li, Guigang

2012-01-01

Anophthalmia is associated with a range of psychosocial difficulties and hydroxyapatite orbital implant insertion and prosthesis wearing is the predominant rehabilitation therapy for anophthalmia. However, few articles have compared preoperative and postoperative psychosocial outcomes using standardized questionnaires. This study aimed to investigate the psychosocial benefits of hydroxyapatite orbital implant insertion and prosthesis wearing in this patient population. In all, 36 participants were tested preoperatively and 6-months postoperatively using standardized measures of anxiety and depression (Hospital Anxiety and Depression Scale), social anxiety and social avoidance (Derriford Appearance Scale-Short Form), and quality of life (World Health Organization Quality of Life Scale-Short Form). Before treatment, levels of depression were comparable with population norms; however, levels of general anxiety were slightly raised, levels of social anxiety, social avoidance, and quality of life were significantly poorer than population norms. Treatment resulted in significant improvement in psychosocial adjustment with improvements in all study variables for the participant group as a whole. Hydroxyapatite orbital implant insertion and prosthesis wearing offers significant improvements in psychological and physical functioning for patients with anophthalmia.

Intramuscular diaphragmatic stimulation for patients with traumatic high cervical injuries and ventilator dependent respiratory failure: A systematic review of safety and effectiveness.

PubMed

Garara, Bhavin; Wood, Alasdair; Marcus, Hani J; Tsang, Kevin; Wilson, Mark H; Khan, Mansoor

2016-03-01

Intramuscular diaphragmatic stimulation using an abdominal laparoscopic approach has been proposed as a safer alternative to traditional phrenic nerve stimulation. It has also been suggested that early implementation of diaphragmatic pacing may prevent diaphragm atrophy and lead to earlier ventilator independence. The aim of this study was therefore to systematically review the safety and effectiveness of intramuscular diaphragmatic stimulators in the treatment of patients with traumatic high cervical injuries resulting in long-term ventilator dependence, with particular emphasis on the affect of timing of insertion of such stimulators. The Cochrane database and PubMed were searched between January 2000 and June 2015. Reference lists of selected papers were also reviewed. The inclusion criteria used to select from the pool of eligible studies were: (1) reported on adult patients with traumatic high cervical injury, who were ventilator-dependant, (2) patients underwent intramuscular diaphragmatic stimulation, and (3) commented on safety and/or effectiveness. 12 articles were included in the review. Reported safety issues post insertion of intramuscular electrodes included pneumothorax, infection, and interaction with pre-existing cardiac pacemaker. Only one procedural failure was reported. The percentage of patients reported as independent of ventilatory support post procedure ranged between 40% and 72.2%. The mean delay of insertion ranged from 40 days to 9.7 years; of note the study with the average shortest delay in insertion reported the greatest percentage of fully weaned patients. Although evidence for intramuscular diaphragmatic stimulation in patients with high cervical injuries and ventilator dependent respiratory failure is currently limited, the technique appears to be safe and effective. Earlier implantation of such devices does not appear to be associated with greater surgical risk, and may be more effective. Further high quality studies are warranted to investigate the impact of delay of insertion on ventilator weaning. Copyright © 2016 Elsevier Ltd. All rights reserved.

Concealed Accessory Pathways with a Single Ventricular and Two Discrete Atrial Insertion Sites.

PubMed

Kipp, Ryan T; Abu Sham'a, Raed; Hiroyuki, Ito; Han, Frederick T; Refaat, Marwan; Hsu, Jonathan C; Field, Michael E; Kopp, Douglas E; Marcus, Gregory M; Scheinman, Melvin M; Hoffmayer, Kurt S

2017-03-01

Atrioventricular reciprocating tachycardia (AVRT) utilizing a concealed accessory pathway is common. It is well appreciated that some patients may have multiple accessory pathways with separate atrial and ventricular insertion sites. We present three cases of AVRT utilizing concealed pathways with evidence that each utilizing a single ventricular insertion and two discrete atrial insertion sites. In case one, two discrete atrial insertion sites were mapped in two separate procedures, and only during the second ablation was the Kent potential identified. Ablation of the Kent potential at this site remote from the two atrial insertion sites resulted in the termination of the retrograde conduction in both pathways. Case two presented with supraventricular tachycardia (SVT) with alternating eccentric atrial activation patterns without alteration in the tachycardia cycle length. The two distinct atrial insertion sites during orthodromic AVRT and ventricular pacing were targeted and each of the two atrial insertion sites were successfully mapped and ablated. In case three, retrograde decremental conduction utilizing both atrial insertion sites was identified prior to ablation. After mapping and ablation of the first discrete atrial insertion site, tachycardia persisted utilizing the second atrial insertion site. Only after ablation of the second atrial insertion site was SVT noninducible, and VA conduction was no longer present. Concealed retrograde accessory pathways with discrete atrial insertion sites may have a common ventricular insertion site. Identification and ablation of the ventricular insertion site or the separate discrete atrial insertion sites result in successful treatment. © 2017 Wiley Periodicals, Inc.

Permanent stenting in "unextractable" common bile duct stones in high risk patients. A prospective randomized study comparing two different stents.

PubMed

Pisello, Franco; Geraci, Girolamo; Li Volsi, Francesco; Modica, Giuseppe; Sciumè, Carmelo

2008-11-01

Endoscopic sphincterotomy (ES) and stone extraction is the treatment of choice for bile duct stones. Therefore, if ES and conventional stone extraction fail, further treatment is mandatory. Insertion of a biliary endoprosthesis is an effective option. We treated 30 high-risk patients (17 women and 13 men, mean age 82 years) affected by difficult common bile duct stones. The patients were randomly assigned preoperatively using closed envelopes (blind randomization) into two groups to receive insertion of polyethylene or hydrophilic hydromer-coated polyurethane stent, respectively. Follow-up was achieved by contacting referring physicians and patient's relatives. Biliary drainage was established in all patients. Early minor complications occurred in 28%. In all these patients, the stent was a definitive measure. Median follow-up was 38 months. Late complications occurred in 34%. Cholangitis was the most frequent. During follow up, 11 patients died, two as result of a biliary-related cause. No statistically significant difference was observed on different stents patency. Endoprosthesis insertion as a permanent therapy is an effective alternative to surgery or dissolution therapy. Therefore, biliary stenting should preferably be restricted to high-risk patients unfit for operative treatment and with a short life expectancy.

The effects of lavender aromatherapy on pain following needle insertion into a fistula in hemodialysis patients.

PubMed

Bagheri-Nesami, Masoumeh; Espahbodi, Fatemeh; Nikkhah, Attieh; Shorofi, Seyed Afshin; Charati, Jamshid Yazdani

2014-02-01

This study sought to determine the effects of lavender aromatherapy on pain following needle insertion into a fistula in patients undergoing hemodialysis. This is a randomized controlled clinical trial in which 92 patients undergoing hemodialysis with arteriovenous fistulas were randomly divided into two groups. The experimental-group patients inhaled lavender essence with a concentration of 10% for 5 min during 3 hemodialysis sessions, while the control-group patients received aromatherapy free of lavender essence. The mean VAS pain intensity score in the experimental and control groups before the intervention was 3.78 ± 0.24 and 4.16 ± 0.32, respectively (p = 0.35). The mean VAS pain intensity score in the experimental and control groups after three aromatherapy sessions was 2.36 ± 0.25 and 3.43 ± 0.31, respectively (p = 0.009). Lavender aromatherapy may be an effective technique to reduce pain following needle insertion into a fistula in hemodialysis patients. Copyright © 2013 Elsevier Ltd. All rights reserved.

A Novel Assay for the Identification of NOTCH1 PEST Domain Mutations in Chronic Lymphocytic Leukemia

PubMed Central

Petroni, Roberta Cardoso; Muto, Nair Hideko; Sitnik, Roberta; de Carvalho, Flavia Pereira; Bacal, Nydia Strachman; Velloso, Elvira Deolinda Rodrigues Pereira; Oliveira, Gislaine Borba; Pinho, João Renato Rebello; Torres, Davi Coe; Mansur, Marcela Braga; Hassan, Rocio; Lorand-Metze, Irene Gyongyvér Heidemarie; Chiattone, Carlos Sérgio; Hamerschlak, Nelson; Mangueira, Cristovão Luis Pitangueira

2016-01-01

Aims. To develop a fast and robust DNA-based assay to detect insertions and deletions mutations in exon 34 that encodes the PEST domain of NOTCH1 in order to evaluate patients with chronic lymphocytic leukemia (CLL). Methods. We designed a multiplexed allele-specific polymerase chain reaction (PCR) combined with a fragment analysis assay to detect specifically the mutation c.7544_7545delCT and possibly other insertions and deletions in exon 34 of NOTCH1. Results. We evaluated our assay in peripheral blood samples from two cohorts of patients with CLL. The frequency of NOTCH1 mutations was 8.4% in the first cohort of 71 unselected CLL patients. We then evaluated a second cohort of 26 CLL patients with known cytogenetic abnormalities that were enriched for patients with trisomy 12. NOTCH1 mutations were detected in 43.7% of the patients with trisomy 12. Conclusions. We have developed a fast and robust assay combining allele-specific PCR and fragment analysis able to detect NOTCH1 PEST domain insertions and deletions. PMID:28074183

The Soft Seal disposable laryngeal mask airway in adults: comparison of two insertion techniques without intra-oral manipulation.

PubMed

Kuvaki, B; Küçükgüçlü, S; Iyilikçi, L; Tuncali, B E; Cinar, O

2008-10-01

We investigated whether insertion of the disposable Soft Seal laryngeal mask airway (SSLM) was successful without intra-oral digital manipulation. One hundred patients undergoing anaesthesia using the SSLM were randomly assigned into two groups. Insertion was performed by either a direct or a rotational technique, both without intra-oral digital manipulation. The primary outcome measure was successful insertion at first attempt. Other outcomes included insertion time, fibreoptic assessment of the airway view and airway morbidity. The first attempt success rate was higher (98%) with the direct technique than with the rotational technique (75%; p = 0.002) but insertion time was faster with the latter method (mean [range] 15 [8-50] s) than with the direct method (20 [8-56] s; p = 0.035). Fibreoptic assessment and airway morbidity were similar in both groups. We conclude that the SSLM can be successfully inserted without intra-oral digital manipulation.

Paracervical Block for Laminaria Insertion Before Second-Trimester Abortion: A Randomized Controlled Trial.

PubMed

Soon, Reni; Tschann, Mary; Salcedo, Jennifer; Stevens, Katelyn; Ahn, Hyeong Jun; Kaneshiro, Bliss

2017-08-01

To evaluate the efficacy of a paracervical block to decrease pain during osmotic dilator insertion before second-trimester abortion. In this double-blind, randomized trial, 41 women undergoing Laminaria insertion before a second-trimester abortion received either a paracervical block with 18 mL 1% lidocaine and 2 mL sodium bicarbonate or a sham block. Women were between 14 and 23 6/7 weeks of gestation. The primary outcome was pain immediately after insertion of Laminaria. Women assessed their pain on a 100-mm visual analog scale. Secondary outcomes included assessment of pain at other times during the insertion procedure and overall satisfaction with pain control. To detect a 25-mm difference in pain immediately after Laminaria insertion, at an α of 0.05 and 80% power, we aimed to enroll 20 patients in each arm. From May 2015 to December 2015, 20 women received a paracervical block and 21 received a sham block. Groups were similar in demographics, including parity, history of surgical abortion, and number of Laminaria placed. The paracervical block reduced pain after Laminaria insertion (median scores 13 mm [interquartile range 2-39] compared with 54 mm [interquartile range 27-61], P=.01, 95% CI -47.0 to -4.0). Women who received a paracervical block also reported higher satisfaction with overall pain control throughout the entire Laminaria insertion procedure (median scores 95 mm [interquartile range 78-100] compared with 70 mm [interquartile range 44-90], P=.05, 95% CI 0.0-37.0). Paracervical block is effective at reducing the pain of Laminaria insertion. Additionally, a paracervical block increases overall patient satisfaction with pain control during Laminaria placement. ClinicalTrials.gov, NCT02454296.

Development of a virtual reality haptic Veress needle insertion simulator for surgical skills training.

PubMed

Okrainec, A; Farcas, M; Henao, O; Choy, I; Green, J; Fotoohi, M; Leslie, R; Wight, D; Karam, P; Gonzalez, N; Apkarian, J

2009-01-01

The Veress needle is the most commonly used technique for creating the pneumoperitoneum at the start of a laparoscopic surgical procedure. Inserting the Veress needle correctly is crucial since errors can cause significant harm to patients. Unfortunately, this technique can be difficult to teach since surgeons rely heavily on tactile feedback while advancing the needle through the various layers of the abdominal wall. This critical step in laparoscopy, therefore, can be challenging for novice trainees to learn without adequate opportunities to practice in a safe environment with no risk of injury to patients. To address this issue, we have successfully developed a prototype of a virtual reality haptic needle insertion simulator using the tactile feedback of 22 surgeons to set realistic haptic parameters. A survey of these surgeons concluded that our device appeared and felt realistic, and could potentially be a useful tool for teaching the proper technique of Veress needle insertion.

Inflation with air via a facepiece for facilitating insertion of a nasogastric tube: a prospective, randomised, double-blind study.

PubMed

Gupta, D; Agarwal, A; Nath, S S; Goswami, D; Saraswat, V; Singh, P K

2007-02-01

Insertion of a nasogastric tube is a routine procedure but during anaesthesia it is often difficult and time consuming. One hundred and sixty adults undergoing elective surgery under general anaesthesia were randomly divided into two groups. After induction of anaesthesia, neuromuscular blockade and tracheal intubation, a nasogastric tube was inserted through the nose with the head of the patient in the neutral position, either with or without prior inflation with air via a facepiece attached to a self-inflating bag applied firmly with the face. Insertion of the nasogastric tube was successful in 75/78 (96%) following inflation compared with 54/80 (68%) without inflation (p<0.001). In four patients receiving inflation, a fibreoptic endoscope was passed as far as the upper oesophageal sphincter; this revealed opening of the upper oesophageal sphincter during inflation.