Sample records for effects test guidelines

  1. 21 CFR 350.60 - Guidelines for effectiveness testing of antiperspirant drug products.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Guidelines for effectiveness testing of antiperspirant drug products. 350.60 Section 350.60 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... Drug Administration is providing guidelines that manufacturers may use in testing for effectiveness...

  2. 21 CFR 350.60 - Guidelines for effectiveness testing of antiperspirant drug products.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Guidelines for effectiveness testing of antiperspirant drug products. 350.60 Section 350.60 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... Drug Administration is providing guidelines that manufacturers may use in testing for effectiveness...

  3. 21 CFR 350.60 - Guidelines for effectiveness testing of antiperspirant drug products.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Guidelines for effectiveness testing of antiperspirant drug products. 350.60 Section 350.60 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... Drug Administration is providing guidelines that manufacturers may use in testing for effectiveness...

  4. 21 CFR 350.60 - Guidelines for effectiveness testing of antiperspirant drug products.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Guidelines for effectiveness testing of antiperspirant drug products. 350.60 Section 350.60 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... Drug Administration is providing guidelines that manufacturers may use in testing for effectiveness...

  5. Now Available – Final Test Guidelines for Ecological Effects

    EPA Pesticide Factsheets

    EPA's “Guidelines for Aquatic and Sediment-Dwelling Fauna, Aquatic Microcosm and Field Testing” are part of a series of test guidelines established by EPA for use in testing pesticides and other chemical substances.

  6. Effect of test concentration in the ready biodegradability test for chemical substances: Improvement of OECD test guideline 301C.

    PubMed

    Nabeoka, Ryosuke; Taruki, Masanori; Kayashima, Takakazu; Yoshida, Tomohiko; Kameya, Takashi

    2016-01-01

    In Japan, understanding the environmental persistence of chemicals is very important for risk assessment, and ready biodegradability tests are mainly conducted according to the Organisation for Economic Co-operation and Development test guideline 301C. However, the highest test concentration specified in test guideline 301C, 100 mg/L, may cause microbial toxicity and incomplete biodegradation. The authors performed test guideline 301C tests at test concentrations of 30 mg/L for 13 substances that were readily biodegradable in ready biodegradability tests but not in test guideline 301C tests. Of the 5 substances with potential to cause microbial toxicity at 100 mg/L, the percentage of biodegradation of sodium dimethyldithiocarbamate, 4-chloro-3-cresol (CC), thymol (THY), and p-tert-butyl-α-methylbenzenepropionaldehyde measured by biochemical oxygen demand (BOD) increased in the test guideline 301C test at 30 mg/L, suggesting a reduction in toxicity effects. Furthermore, CC and THY met the criteria for ready biodegradability, which are more than 60% of biodegradation by BOD and a 10-d window. Of the 8 substances with a low potential for causing microbial toxicity at 100 mg/L, the percentage of biodegradation of only 2-(diethylamino)ethanol increased in the test guideline 301C test at 30 mg/L. Employing a lower test concentration in the standard test guideline 301C test will contribute to improvement of consistency between results of a test guideline 301C test and other ready biodegradability tests. © 2015 SETAC.

  7. 76 FR 74063 - Mandatory Guidelines for Federal Workplace Drug Testing Programs

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-30

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Mandatory Guidelines for Federal Workplace Drug Testing... Federal Workplace Drug Testing Programs (Mandatory Guidelines), effective on October 1, 2010, addresses... for physicians performing a review of Federal employee drug testing results that seek approval by the...

  8. 78 FR 2675 - Mandatory Guidelines for Federal Workplace Drug Testing Programs

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-14

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Mandatory Guidelines for Federal Workplace Drug Testing... Federal Workplace Drug Testing Programs (Mandatory Guidelines), effective on October 1, 2010, addresses... performing a review of Federal employee drug testing results that seek approval by the Secretary must submit...

  9. 75 FR 76478 - Mandatory Guidelines for Federal Workplace Drug Testing Programs

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-08

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Mandatory Guidelines for Federal Workplace Drug Testing... Drug Testing Programs (Mandatory Guidelines) which took effect on October 1, 2010 address the role and... Federal employee drug testing results that seek approval by the Secretary must submit their qualifications...

  10. 21 CFR 350.60 - Guidelines for effectiveness testing of antiperspirant drug products.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    .... These guidelines are on file in the Dockets Management Branch (HFA-305), Food and Drug Administration... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Guidelines for effectiveness testing of antiperspirant drug products. 350.60 Section 350.60 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF...

  11. 40 CFR 799.9325 - TSCA 90-day dermal toxicity.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Health Effects Test Guidelines § 799.9325 TSCA 90-day dermal toxicity. (a) Scope. This section is...-observed-effects level (NOEL) and toxic effects associated with continuous or repeated exposure to a test... human exposure. (b) Source. The source material used in developing this TSCA test guideline is the...

  12. 40 CFR 799.9325 - TSCA 90-day dermal toxicity.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Health Effects Test Guidelines § 799.9325 TSCA 90-day dermal toxicity. (a) Scope. This section is...-observed-effects level (NOEL) and toxic effects associated with continuous or repeated exposure to a test... human exposure. (b) Source. The source material used in developing this TSCA test guideline is the...

  13. 40 CFR 799.9325 - TSCA 90-day dermal toxicity.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Health Effects Test Guidelines § 799.9325 TSCA 90-day dermal toxicity. (a) Scope. This section is...-observed-effects level (NOEL) and toxic effects associated with continuous or repeated exposure to a test... human exposure. (b) Source. The source material used in developing this TSCA test guideline is the...

  14. 40 CFR 799.9325 - TSCA 90-day dermal toxicity.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... Health Effects Test Guidelines § 799.9325 TSCA 90-day dermal toxicity. (a) Scope. This section is...-observed-effects level (NOEL) and toxic effects associated with continuous or repeated exposure to a test... human exposure. (b) Source. The source material used in developing this TSCA test guideline is the...

  15. 40 CFR 799.9325 - TSCA 90-day dermal toxicity.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Health Effects Test Guidelines § 799.9325 TSCA 90-day dermal toxicity. (a) Scope. This section is...-observed-effects level (NOEL) and toxic effects associated with continuous or repeated exposure to a test... human exposure. (b) Source. The source material used in developing this TSCA test guideline is the...

  16. Effects of Direct-to-Consumer Advertising and Clinical Guidelines on Appropriate Use of Human Papillomavirus DNA Tests

    PubMed Central

    2011-01-01

    Background Both clinical guidelines and direct-to-consumer (DTC) advertising influence use of new health care technologies, but little is known about their relative effects. The introduction of a cervical cancer screening test in 2000 offered a unique opportunity to assess the two strategies. Objective To evaluate the effects of clinical guidelines and a targeted DTC advertising campaign on overall and appropriate use of human papillomavirus (HPV) DNA tests. Research Design Quasi-experimental study using difference-in-differences analysis. Data were MarketScan private insurance claims for 500,000 women ages 21 to 64 enrolled at least 12 consecutive months from January 2001 through December 2005. Results Both clinical guidelines and DTC advertising were associated with increases in overall HPV DNA test use. DTC advertising was associated with a statistically significant increase in HPV DNA test use in two groups of DTC cities (+5.57 percent, p<0.0001; +2.54 percent, p<0.0001). DTC advertising was associated with comparable increases in the probability of appropriate and inappropriate use of the HPV DNA test in primary screening. Clinical guideline releases from the American College of Obstetricians and Gynecologists, and by a co-sponsored panel, were associated with greater increases in HPV DNA tests for appropriate primary screening than for inappropriate primary screening (β=0.3347, p<0.05 and β=0.4175, p<0.01). Conclusions DTC advertising was associated with increased overall use of a cervical cancer screening test, while clinical guidelines were differentially associated with increased appropriate use. These findings suggest distinct influences of consumer marketing and professional guidelines on the use of health care products and services. PMID:21150798

  17. Effects of direct-to-consumer advertising and clinical guidelines on appropriate use of human papillomavirus DNA tests.

    PubMed

    Price, Rebecca Anhang; Frank, Richard G; Cleary, Paul D; Goldie, Sue J

    2011-02-01

    Both clinical guidelines and direct-to-consumer (DTC) advertising influence the use of new health care technologies, but little is known about their relative effects. The introduction of a cervical cancer screening test in 2000 offered a unique opportunity to assess the 2 strategies. To evaluate the effects of clinical guidelines and a targeted DTC advertising campaign on overall and appropriate use of human papillomavirus (HPV) DNA tests. Quasi-experimental study using difference-in-differences analysis. Data were MarketScan private insurance claims for 500,000 women aged 21 to 64 enrolled at least 12 consecutive months from January 2001 through December 2005. Both clinical guidelines and DTC advertising were associated with increases in overall HPV DNA test use. DTC advertising was associated with a statistically significant increase in HPV DNA test use in 2 groups of DTC cities (+5.57%, P < 0.0001; +2.54%, P < 0.0001). DTC advertising was associated with comparable increases in the probability of appropriate and inappropriate use of the HPV DNA test in primary screening. Clinical guideline releases from the American College of Obstetricians and Gynecologists, and by a cosponsored panel, were associated with greater increases in HPV DNA tests for appropriate primary screening than for inappropriate primary screening (β = 0.3347, P < 0.05 and β = 0.4175, P < 0.01). DTC advertising was associated with increased overall use of a cervical cancer screening test, whereas clinical guidelines were differentially associated with increased appropriate use. These findings suggest distinct influences of consumer marketing and professional guidelines on the use of health care products and services.

  18. 40 CFR 799.9310 - TSCA 90-day oral toxicity in rodents.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... REQUIREMENTS Health Effects Test Guidelines § 799.9310 TSCA 90-day oral toxicity in rodents. (a) Scope. This... a test substance for a period of 90 days. This study is not capable of determining those effects... exposure. (b) Source. The source material used in developing this TSCA test guideline is the Office of...

  19. 40 CFR 799.9310 - TSCA 90-day oral toxicity in rodents.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... REQUIREMENTS Health Effects Test Guidelines § 799.9310 TSCA 90-day oral toxicity in rodents. (a) Scope. This... a test substance for a period of 90 days. This study is not capable of determining those effects... exposure. (b) Source. The source material used in developing this TSCA test guideline is the Office of...

  20. 40 CFR 799.9310 - TSCA 90-day oral toxicity in rodents.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... REQUIREMENTS Health Effects Test Guidelines § 799.9310 TSCA 90-day oral toxicity in rodents. (a) Scope. This... a test substance for a period of 90 days. This study is not capable of determining those effects... exposure. (b) Source. The source material used in developing this TSCA test guideline is the Office of...

  1. 40 CFR 799.9310 - TSCA 90-day oral toxicity in rodents.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... REQUIREMENTS Health Effects Test Guidelines § 799.9310 TSCA 90-day oral toxicity in rodents. (a) Scope. This... a test substance for a period of 90 days. This study is not capable of determining those effects... exposure. (b) Source. The source material used in developing this TSCA test guideline is the Office of...

  2. 40 CFR 799.9310 - TSCA 90-day oral toxicity in rodents.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... REQUIREMENTS Health Effects Test Guidelines § 799.9310 TSCA 90-day oral toxicity in rodents. (a) Scope. This... a test substance for a period of 90 days. This study is not capable of determining those effects... exposure. (b) Source. The source material used in developing this TSCA test guideline is the Office of...

  3. 40 CFR 797.1950 - Mysid shrimp chronic toxicity test.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... control and treatment groups. This time cannot be specified because of possible delays in sexual... control groups; PCONTROL ACT (CONTINUED) ENVIRONMENTAL EFFECTS TESTING GUIDELINES Aquatic Guidelines § 797.1950...

  4. 40 CFR 797.1950 - Mysid shrimp chronic toxicity test.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... control and treatment groups. This time cannot be specified because of possible delays in sexual... control groups; PCONTROL ACT (CONTINUED) ENVIRONMENTAL EFFECTS TESTING GUIDELINES Aquatic Guidelines § 797.1950...

  5. 40 CFR 797.1950 - Mysid shrimp chronic toxicity test.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... control and treatment groups. This time cannot be specified because of possible delays in sexual... control groups; PCONTROL ACT (CONTINUED) ENVIRONMENTAL EFFECTS TESTING GUIDELINES Aquatic Guidelines § 797.1950...

  6. 40 CFR 797.1950 - Mysid shrimp chronic toxicity test.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... control and treatment groups. This time cannot be specified because of possible delays in sexual... control groups; PCONTROL ACT (CONTINUED) ENVIRONMENTAL EFFECTS TESTING GUIDELINES Aquatic Guidelines § 797.1950...

  7. 40 CFR 797.1330 - Daphnid chronic toxicity test.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... an extended period of time. In this test guideline, mortality and reproduction (and optionally... exposure over a specified period of time. In this guideline, the effect measured is immobilization. (4..., wet weight) to the volume (liters) of test solution in a test chamber at a point in time or passing...

  8. 40 CFR 797.1330 - Daphnid chronic toxicity test.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... an extended period of time. In this test guideline, mortality and reproduction (and optionally... exposure over a specified period of time. In this guideline, the effect measured is immobilization. (4..., wet weight) to the volume (liters) of test solution in a test chamber at a point in time or passing...

  9. 40 CFR 797.1330 - Daphnid chronic toxicity test.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... an extended period of time. In this test guideline, mortality and reproduction (and optionally... exposure over a specified period of time. In this guideline, the effect measured is immobilization. (4..., wet weight) to the volume (liters) of test solution in a test chamber at a point in time or passing...

  10. 40 CFR 797.1330 - Daphnid chronic toxicity test.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... an extended period of time. In this test guideline, mortality and reproduction (and optionally... exposure over a specified period of time. In this guideline, the effect measured is immobilization. (4..., wet weight) to the volume (liters) of test solution in a test chamber at a point in time or passing...

  11. 40 CFR 797.1330 - Daphnid chronic toxicity test.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... an extended period of time. In this test guideline, mortality and reproduction (and optionally... exposure over a specified period of time. In this guideline, the effect measured is immobilization. (4..., wet weight) to the volume (liters) of test solution in a test chamber at a point in time or passing...

  12. 40 CFR 797.1930 - Mysid shrimp acute toxicity test.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... in a control group. (ii) Acclimation. (A) Any change in the temperature and chemistry of the dilution... SUBSTANCES CONTROL ACT (CONTINUED) ENVIRONMENTAL EFFECTS TESTING GUIDELINES Aquatic Guidelines § 797.1930... test regulations under the Toxic Substances Control Act (TSCA) (Pub. L. 94-469, 90 Stat. 2003, 15 U.S.C...

  13. 40 CFR 797.1930 - Mysid shrimp acute toxicity test.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... in a control group. (ii) Acclimation. (A) Any change in the temperature and chemistry of the dilution... SUBSTANCES CONTROL ACT (CONTINUED) ENVIRONMENTAL EFFECTS TESTING GUIDELINES Aquatic Guidelines § 797.1930... test regulations under the Toxic Substances Control Act (TSCA) (Pub. L. 94-469, 90 Stat. 2003, 15 U.S.C...

  14. 40 CFR 797.1930 - Mysid shrimp acute toxicity test.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... in a control group. (ii) Acclimation. (A) Any change in the temperature and chemistry of the dilution... SUBSTANCES CONTROL ACT (CONTINUED) ENVIRONMENTAL EFFECTS TESTING GUIDELINES Aquatic Guidelines § 797.1930... test regulations under the Toxic Substances Control Act (TSCA) (Pub. L. 94-469, 90 Stat. 2003, 15 U.S.C...

  15. 40 CFR 797.1930 - Mysid shrimp acute toxicity test.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... in a control group. (ii) Acclimation. (A) Any change in the temperature and chemistry of the dilution... SUBSTANCES CONTROL ACT (CONTINUED) ENVIRONMENTAL EFFECTS TESTING GUIDELINES Aquatic Guidelines § 797.1930... test regulations under the Toxic Substances Control Act (TSCA) (Pub. L. 94-469, 90 Stat. 2003, 15 U.S.C...

  16. 40 CFR 795.228 - Oral/dermal pharmacokinetics.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... CONTROL ACT (CONTINUED) PROVISIONAL TEST GUIDELINES Provisional Health Effects Guidelines § 795.228 Oral... laboratory. The animals shall be selected at random for the test groups and any animal showing signs of ill health shall not be used. In all studies, unless otherwise specified, each test group shall contain at...

  17. 40 CFR 795.228 - Oral/dermal pharmacokinetics.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... CONTROL ACT (CONTINUED) PROVISIONAL TEST GUIDELINES Provisional Health Effects Guidelines § 795.228 Oral... laboratory. The animals shall be selected at random for the test groups and any animal showing signs of ill health shall not be used. In all studies, unless otherwise specified, each test group shall contain at...

  18. 40 CFR 795.228 - Oral/dermal pharmacokinetics.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... CONTROL ACT (CONTINUED) PROVISIONAL TEST GUIDELINES Provisional Health Effects Guidelines § 795.228 Oral... laboratory. The animals shall be selected at random for the test groups and any animal showing signs of ill health shall not be used. In all studies, unless otherwise specified, each test group shall contain at...

  19. 40 CFR 795.228 - Oral/dermal pharmacokinetics.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... CONTROL ACT (CONTINUED) PROVISIONAL TEST GUIDELINES Provisional Health Effects Guidelines § 795.228 Oral... laboratory. The animals shall be selected at random for the test groups and any animal showing signs of ill health shall not be used. In all studies, unless otherwise specified, each test group shall contain at...

  20. 40 CFR 795.228 - Oral/dermal pharmacokinetics.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... CONTROL ACT (CONTINUED) PROVISIONAL TEST GUIDELINES Provisional Health Effects Guidelines § 795.228 Oral... laboratory. The animals shall be selected at random for the test groups and any animal showing signs of ill health shall not be used. In all studies, unless otherwise specified, each test group shall contain at...

  1. Considerations for a Proton Single Event Effects (SEE) Guideline

    NASA Technical Reports Server (NTRS)

    LaBel, Kenneth A.

    2010-01-01

    The intent of this document is to provide guidance on when and what type of -SEE tests should be performed on a device under test (OUT) based on orbit, technology, existing data, and application. It is NOT intended to provide a detailed guideline for how to perform proton SEE radiation tests on electronics.

  2. Considerations for a Proton Single Event Effects (SEE) Guideline

    NASA Technical Reports Server (NTRS)

    LaBel, Kenneth A.

    2010-01-01

    The intent of this document is to provide guidance on when and what type of SEE tests should be performed on a device under test (DUT) based on orbit, technology, existing data, and application. It is NOT intended to provide a detailed guideline for how to perform proton SEE radiation tests on electronics.

  3. The Instrument for Measuring the Implementation Situation of Traditional Chinese Medicine Guideline: Evaluation and Application

    PubMed Central

    Wang, Yangyang; Chen, Yaolong; Wang, Xiaoyun; Deng, Jingwen

    2017-01-01

    Clinical practice guidelines play an important role in reducing the variations in clinical practices and improving the quality of care. To assess the real effect, measuring its implementation situation is needed. The implementation situation can be reflected by testing the consistency between the actual clinical practice and the guideline. We constructed an instrument to measure the implementation situation of Traditional Chinese Medicine (TCM) guideline through consistency testing. The main objectives of our study were to validate the instrument and evaluate the implementation situation of menopause syndrome guideline of TCM, using the data from the consistency test of comparing the medical records with the guideline. A total of 621 cases were included for data analysis. Cronbach's Alpha coefficient is 0.73. The model fit of 7 items in four dimensions was good (SRMR = 0.04; GFI = 0.97; NFI = 0.97; TLI = 0.96; CFI = 0.98; AGFI = 0.90). This instrument is of good reliability and validity. It can help the guideline developers to measure the implementation situation, find the reasons affecting the implementation, and revise the guideline. The method of using consistency test to measure the implementation situation may provide a sample for evaluating the guideline implementation in other fields. PMID:29234379

  4. Standards for Radiation Effects Testing: Ensuring Scientific Rigor in the Face of Budget Realities and Modern Device Challenges

    NASA Technical Reports Server (NTRS)

    Lauenstein, J M.

    2015-01-01

    An overview is presented of the space radiation environment and its effects on electrical, electronic, and electromechanical parts. Relevant test standards and guidelines are listed. Test standards and guidelines are necessary to ensure best practices, minimize and bound systematic and random errors, and to ensure comparable results from different testers and vendors. Test standards are by their nature static but exist in a dynamic environment of advancing technology and radiation effects research. New technologies, failure mechanisms, and advancement in our understanding of known failure mechanisms drive the revision or development of test standards. Changes to standards must be weighed against their impact on cost and existing part qualifications. There must be consensus on new best practices. The complexity of some new technologies exceeds the scope of existing test standards and may require development of a guideline specific to the technology. Examples are given to illuminate the value and limitations of key radiation test standards as well as the challenges in keeping these standards up to date.

  5. 40 CFR 795.120 - Gammarid acute toxicity test.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... culture container. The control group shall be exposed to the same dilution water, conditions and... CONTROL ACT (CONTINUED) PROVISIONAL TEST GUIDELINES Provisional Environmental Effects Guidelines § 795.120... under the Toxic Substances Control Act (TSCA) (Pub. L. 94-469, 90 Stat. 2003 (15 U.S.C. 2601 et seq...

  6. 40 CFR 795.120 - Gammarid acute toxicity test.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... culture container. The control group shall be exposed to the same dilution water, conditions and... CONTROL ACT (CONTINUED) PROVISIONAL TEST GUIDELINES Provisional Environmental Effects Guidelines § 795.120... under the Toxic Substances Control Act (TSCA) (Pub. L. 94-469, 90 Stat. 2003 (15 U.S.C. 2601 et seq...

  7. 40 CFR 795.120 - Gammarid acute toxicity test.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... culture container. The control group shall be exposed to the same dilution water, conditions and... CONTROL ACT (CONTINUED) PROVISIONAL TEST GUIDELINES Provisional Environmental Effects Guidelines § 795.120... under the Toxic Substances Control Act (TSCA) (Pub. L. 94-469, 90 Stat. 2003 (15 U.S.C. 2601 et seq...

  8. 40 CFR 795.120 - Gammarid acute toxicity test.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... culture container. The control group shall be exposed to the same dilution water, conditions and... CONTROL ACT (CONTINUED) PROVISIONAL TEST GUIDELINES Provisional Environmental Effects Guidelines § 795.120... under the Toxic Substances Control Act (TSCA) (Pub. L. 94-469, 90 Stat. 2003 (15 U.S.C. 2601 et seq...

  9. 40 CFR 795.120 - Gammarid acute toxicity test.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... culture container. The control group shall be exposed to the same dilution water, conditions and... CONTROL ACT (CONTINUED) PROVISIONAL TEST GUIDELINES Provisional Environmental Effects Guidelines § 795.120... under the Toxic Substances Control Act (TSCA) (Pub. L. 94-469, 90 Stat. 2003 (15 U.S.C. 2601 et seq...

  10. 40 CFR 795.231 - Pharmacokinetics of isopropanal.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... SUBSTANCES CONTROL ACT (CONTINUED) PROVISIONAL TEST GUIDELINES Provisional Health Effects Guidelines § 795... groups and any animal showing signs of ill health shall not be used. In all studies, unless otherwise specified, each test group shall contain at least four animals of each sex for a total of at least eight...

  11. 40 CFR 795.231 - Pharmacokinetics of isopropanal.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... SUBSTANCES CONTROL ACT (CONTINUED) PROVISIONAL TEST GUIDELINES Provisional Health Effects Guidelines § 795... groups and any animal showing signs of ill health shall not be used. In all studies, unless otherwise specified, each test group shall contain at least four animals of each sex for a total of at least eight...

  12. 40 CFR 795.231 - Pharmacokinetics of isopropanal.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... SUBSTANCES CONTROL ACT (CONTINUED) PROVISIONAL TEST GUIDELINES Provisional Health Effects Guidelines § 795... groups and any animal showing signs of ill health shall not be used. In all studies, unless otherwise specified, each test group shall contain at least four animals of each sex for a total of at least eight...

  13. 40 CFR 795.231 - Pharmacokinetics of isopropanal.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... SUBSTANCES CONTROL ACT (CONTINUED) PROVISIONAL TEST GUIDELINES Provisional Health Effects Guidelines § 795... groups and any animal showing signs of ill health shall not be used. In all studies, unless otherwise specified, each test group shall contain at least four animals of each sex for a total of at least eight...

  14. 40 CFR 795.231 - Pharmacokinetics of isopropanal.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... SUBSTANCES CONTROL ACT (CONTINUED) PROVISIONAL TEST GUIDELINES Provisional Health Effects Guidelines § 795... groups and any animal showing signs of ill health shall not be used. In all studies, unless otherwise specified, each test group shall contain at least four animals of each sex for a total of at least eight...

  15. Evaluation of Internet-Based Clinical Decision Support Systems

    PubMed Central

    Thomas, Karl W; Dayton, Charles S

    1999-01-01

    Background Scientifically based clinical guidelines have become increasingly used to educate physicians and improve quality of care. While individual guidelines are potentially useful, repeated studies have shown that guidelines are ineffective in changing physician behavior. The Internet has evolved as a potentially useful tool for guideline education, dissemination, and implementation because of its open standards and its ability to provide concise, relevant clinical information at the location and time of need. Objective Our objective was to develop and test decision support systems (DSS) based on clinical guidelines which could be delivered over the Internet for two disease models: asthma and tuberculosis (TB) preventive therapy. Methods Using open standards of HTML and CGI, we developed an acute asthma severity assessment DSS and a preventative tuberculosis treatment DSS based on content from national guidelines that are recognized as standards of care. Both DSS's are published on the Internet and operate through a decision algorithm developed from the parent guidelines with clinical information provided by the user at the point of clinical care. We tested the effectiveness of each DSS in influencing physician decisions using clinical scenario testing. Results We first validated the asthma algorithm by comparing asthma experts' decisions with the decisions reached by nonpulmonary nurses using the computerized DSS. Using the DSS, nurses scored the same as experts (89% vs. 88%; p = NS). Using the same scenario test instrument, we next compared internal medicine residents using the DSS with residents using a printed version of the National Asthma Education Program-2 guidelines. Residents using the computerized DSS scored significantly better than residents using the paper-based guidelines (92% vs. 84%; p <0.002). We similarly compared residents using the computerized TB DSS to residents using a printed reference card; the residents using the computerized DSS scored significantly better (95.8% vs. 56.6% correct; p<0.001). Conclusions Previous work has shown that guidelines disseminated through traditional educational interventions have minimal impact on physician behavior. Although computerized DSS have been effective in altering physician behavior, many of these systems are not widely available. We have developed two clinical DSS's based on national guidelines and published them on the Internet. Both systems improved physician compliance with national guidelines when tested in clinical scenarios. By providing information that is coupled to relevant activity, we expect that these widely available DSS's will serve as effective educational tools to positively impact physician behavior. PMID:11720915

  16. Diagnostic hearing testing of infants aged 0-36 months in 3 South African provinces - Comparison of audiology records to HPCSA guidelines.

    PubMed

    Moodley, Selvarani; Störbeck, Claudine

    2016-12-01

    Within the Early Hearing Detection and Intervention (EHDI) pathway, which includes the processes of screening, diagnosis and intervention for paediatric hearing loss, paediatric diagnostic audiology involves a battery of specific tests and procedures. International studies have highlighted a golden standard for diagnosis of paediatric hearing loss as based on the Joint Committee of Infant Hearing (2007) diagnostic guidelines, closely resembling the HPCSA diagnostic guidelines. There are limited South African studies on the processes and protocols followed in diagnostic paediatric audiology. This study aims to provide a comparison for how the tests used for diagnosis of paediatric hearing loss in South Africa (within both the public and private healthcare sectors) compare to the HPCSA recommended diagnostic guidelines. A retrospective record review of paediatric clients with hearing loss (recruited through nonprobability convenience sampling) was conducted. This study is part of a longitudinal study of 711 deaf or hard of hearing children referred to the HI HOPES early intervention programme from September 2006 to December 2011. Diagnostic data from audiology reports of 117 children between 0 and 36 months were coded and analysed. Large variation was found in the tests included in the diagnostic audiology reports. For 22 children (19%) a comprehensive test battery was used. Health Professions Council of South Africa (HPCSA) recommended guidelines for diagnostic testing were not followed in any of the records analysed. Components of the HPCSA recommended test battery most frequently omitted was bone conduction testing. For both electrophysiology and behavioural testing, there was limited frequency specificity information. This exclusion of information is evidence of deficiencies in data recording and management, as well as having an effect on accuracy of classification of degree and type of hearing loss. There are gaps in age-appropriate assessment protocols, which will have an effect on accurate differential diagnosis of paediatric hearing loss. Reasons for not including all testing components of the HPCSA recommended guidelines, as well as the possibility of developing guidelines more relevant to a developing world context, should be explored. There might be a need for. The impact of South African specific factors that have an effect on provision of accurate paediatric diagnostic audiology services should be determined. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  17. Impact of a clinical guideline for prescribing antibiotics to inpatients reporting penicillin or cephalosporin allergy.

    PubMed

    Blumenthal, Kimberly G; Shenoy, Erica S; Varughese, Christy A; Hurwitz, Shelley; Hooper, David C; Banerji, Aleena

    2015-10-01

    Self-reported penicillin allergy infrequently reflects an inability to tolerate penicillins. Inpatients reporting penicillin allergy receive alternative antibiotics that might be broader spectrum, more toxic, or less effective. To develop and assess a clinical guideline for the general inpatient provider that directs taking a history and prescribing antibiotics for patients with penicillin or cephalosporin allergy. A guideline was implemented to assist providers with assessing allergy history and prescribing antibiotics for patients with reported penicillin or cephalosporin allergy. The guideline used a standard 2-step graded challenge or test dose. A quasi-experimental study was performed to assess safety, feasibility, and impact on antibiotic use by comparing treatment 21 months before guideline implementation with 12 months after guideline implementation. Significantly more test doses to β-lactam antibiotics were performed monthly after vs before guideline implementation (median 14.5, interquartile range 13-16.25, vs 2, interquartile range 1-3.25, P < .001). Seven adverse drug reactions occurred during guideline-driven test doses, with no significant difference in rate (3.9% vs 6.1%, P = .44) or severity (P > .5) between periods. Guideline-driven test doses decreased alternative antimicrobial therapy after the test dose, including vancomycin (68.3% vs 37.2%, P < .001), aztreonam (11.5% vs 0.5%, P < .001), aminoglycosides (6.0% vs 1.1%, P = .004), and fluoro quinolones (15.3% vs 3.3%, P < .001). The implementation of an inpatient antibiotic prescribing guideline for patients with penicillin or cephalosporin allergy was associated with an almost 7-fold increase in the number of test doses to β-lactams without increased adverse drug reactions. Patients assessed with guideline-driven test doses were observed to have significantly decreased alternative antibiotic exposure. Copyright © 2015 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

  18. Developmental Neurotoxicology: History and Outline of ...

    EPA Pesticide Factsheets

    The present work provides a brief review of basic concepts in developmental neurotoxicology, as well as current representative testing guidelines for evaluating developmental neurotoxicity (DNT) of xenobiotics. Historically, DNT was initially recognized as a “functional” teratogenicity: the main concern was that prenatal and/or early postnatal exposures to chemicals during critical periods of central nervous system (CNS) development would cause later functional abnormalities of the brain. Current internationally harmonized DNT study guidelines are thus intended to predict adverse effects of test compounds on the developing CNS by observing such postnatal parameters as motor activity, startle response, and learning and memory, as well as neropathological alterations. The reliability of current DNT study guidelines and sensitivity of testing methodologies recommended in these guidelines have been confirmed by retrospective evaluations of the many international and domestic collaborative validation studies in developed nations including Japan. Invited review with brief review of basic concepts in developmental neurotoxicology, as well as current representative testing guidelines for evaluating developmental neurotoxicity (DNT) of xenobiotics.

  19. Evaluation of the theory-based Quality Improvement in Physical Therapy (QUIP) programme: a one-group, pre-test post-test pilot study.

    PubMed

    Rutten, Geert M; Harting, Janneke; Bartholomew, L Kay; Schlief, Angelique; Oostendorp, Rob A B; de Vries, Nanne K

    2013-05-25

    Guideline adherence in physical therapy is far from optimal, which has consequences for the effectiveness and efficiency of physical therapy care. Programmes to enhance guideline adherence have, so far, been relatively ineffective. We systematically developed a theory-based Quality Improvement in Physical Therapy (QUIP) programme aimed at the individual performance level (practicing physiotherapists; PTs) and the practice organization level (practice quality manager; PQM). The aim of the study was to pilot test the multilevel QUIP programme's effectiveness and the fidelity, acceptability and feasibility of its implementation. A one-group, pre-test, post-test pilot study (N = 8 practices; N = 32 PTs, 8 of whom were also PQMs) done between September and December 2009. Guideline adherence was measured using clinical vignettes that addressed 12 quality indicators reflecting the guidelines' main recommendations. Determinants of adherence were measured using quantitative methods (questionnaires). Delivery of the programme and management changes were assessed using qualitative methods (observations, group interviews, and document analyses). Changes in adherence and determinants were tested in the paired samples T-tests and expressed in effect sizes (Cohen's d). Overall adherence did not change (3.1%; p = .138). Adherence to three quality indicators improved (8%, 24%, 43%; .000 ≤ p ≤ .023). Adherence to one quality indicator decreased (-15.7%; p = .004). Scores on various determinants of individual performance improved and favourable changes at practice organizational level were observed. Improvements were associated with the programme's multilevel approach, collective goal setting, and the application of self-regulation; unfavourable findings with programme deficits. The one-group pre-test post-test design limits the internal validity of the study, the self-selected sample its external validity. The QUIP programme has the potential to change physical therapy practice but needs considerable revision to induce the ongoing quality improvement process that is required to optimize overall guideline adherence. To assess its value, the programme needs to be tested in a randomized controlled trial.

  20. NASA Electronic Parts and Packaging Field Programmable Gate Array Single Event Effects Test Guideline Update

    NASA Technical Reports Server (NTRS)

    Berg, Melanie D.; LaBel, Kenneth A.

    2018-01-01

    The following are updated or new subjects added to the FPGA SEE Test Guidelines manual: academic versus mission specific device evaluation, single event latch-up (SEL) test and analysis, SEE response visibility enhancement during radiation testing, mitigation evaluation (embedded and user-implemented), unreliable design and its affects to SEE Data, testing flushable architectures versus non-flushable architectures, intellectual property core (IP Core) test and evaluation (addresses embedded and user-inserted), heavy-ion energy and linear energy transfer (LET) selection, proton versus heavy-ion testing, fault injection, mean fluence to failure analysis, and mission specific system-level single event upset (SEU) response prediction. Most sections within the guidelines manual provide information regarding best practices for test structure and test system development. The scope of this manual addresses academic versus mission specific device evaluation and visibility enhancement in IP Core testing.

  1. NASA Electronic Parts and Packaging (NEPP) Field Programmable Gate Array (FPGA) Single Event Effects (SEE) Test Guideline Update

    NASA Technical Reports Server (NTRS)

    Berg, Melanie D.; LaBel, Kenneth A.

    2018-01-01

    The following are updated or new subjects added to the FPGA SEE Test Guidelines manual: academic versus mission specific device evaluation, single event latch-up (SEL) test and analysis, SEE response visibility enhancement during radiation testing, mitigation evaluation (embedded and user-implemented), unreliable design and its affects to SEE Data, testing flushable architectures versus non-flushable architectures, intellectual property core (IP Core) test and evaluation (addresses embedded and user-inserted), heavy-ion energy and linear energy transfer (LET) selection, proton versus heavy-ion testing, fault injection, mean fluence to failure analysis, and mission specific system-level single event upset (SEU) response prediction. Most sections within the guidelines manual provide information regarding best practices for test structure and test system development. The scope of this manual addresses academic versus mission specific device evaluation and visibility enhancement in IP Core testing.

  2. Spillover effects of HIV testing policies: changes in HIV testing guidelines and HCV testing practices in drug treatment programs in the United States.

    PubMed

    Frimpong, Jemima A; D'Aunno, Thomas; Helleringer, Stéphane; Metsch, Lisa R

    2016-07-29

    To examine the extent to which state adoption of the Centers for Disease Control and Prevention (CDC) 2006 revisions to adult and adolescent HIV testing guidelines is associated with availability of other important prevention and medical services. We hypothesized that in states where the pretest counseling requirement for HIV testing was dropped from state legislation, substance use disorder treatment programs would have higher availability of HCV testing services than in states that had maintained this requirement. We analyzed a nationally representative sample of 383 opioid treatment programs from the 2005 and 2011 National Drug Abuse Treatment System Survey (NDATSS). Data were collected from program directors and clinical supervisors through telephone surveys. Multivariate logistic regression models were used to measure associations between state adoption of CDC recommended guidelines for HIV pretest counseling and availability of HCV testing services. The effects of HIV testing legislative changes on HCV testing practices varied by type of opioid treatment program. In states that had removed the requirement for HIV pretest counseling, buprenorphine-only programs were more likely to offer HCV testing to their patients. The positive spillover effect of HIV pretest counseling policies, however, did not extend to methadone programs and did not translate into increased availability of on-site HCV testing in either program type. Our findings highlight potential positive spillover effects of HIV testing policies on HCV testing practices. They also suggest that maximizing the benefits of HIV policies may require other initiatives, including resources and programmatic efforts that support systematic integration with other services and effective implementation.

  3. 40 CFR 799.9135 - TSCA acute inhalation toxicity with histopathology.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... TESTING REQUIREMENTS Health Effects Test Guidelines § 799.9135 TSCA acute inhalation toxicity with... Substances Control Act (TSCA). In the assessment and evaluation of the potential human health effects of chemical substances, it is appropriate to test for acute inhalation toxic effects. The goals of this test...

  4. 40 CFR 799.9135 - TSCA acute inhalation toxicity with histopathology.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... TESTING REQUIREMENTS Health Effects Test Guidelines § 799.9135 TSCA acute inhalation toxicity with... Substances Control Act (TSCA). In the assessment and evaluation of the potential human health effects of chemical substances, it is appropriate to test for acute inhalation toxic effects. The goals of this test...

  5. 40 CFR 799.9135 - TSCA acute inhalation toxicity with histopathology.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... TESTING REQUIREMENTS Health Effects Test Guidelines § 799.9135 TSCA acute inhalation toxicity with... Substances Control Act (TSCA). In the assessment and evaluation of the potential human health effects of chemical substances, it is appropriate to test for acute inhalation toxic effects. The goals of this test...

  6. Guidelines for developing effective health education service in a national health agency.

    PubMed

    Ochor, J O

    1983-01-01

    The constraints facing health education include: the fragmentation and dispersal of health-educational services among different agencies and personnel; lack of policy guidelines; ineffectively organized and inefficiently managed health education systems; poor hierarchical status and inadequacy of resources. To resolve these constraints, national health education systems in health agencies should be developed on the basis of stipulated guidelines that could ensure their viability, efficiency and effectiveness. A study at the African Regional Health Education Centre, Ibadan, Nigeria, has yielded thirty synthesized guidelines. The "guidelines" were empirically tested as an evaluation tool by assessing the operational and organizational status of Oyo State Health Education Unit, Ibadan, Nigeria. These guidelines are adaptable to local conditions to enhance the re-organization, re-orientation and consolidation of health education in national health agencies.

  7. 40 CFR 798.4350 - Inhalation developmental toxicity study.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ...) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) HEALTH EFFECTS TESTING GUIDELINES Specific Organ/Tissue... million (ppm). (6) “No-observed-effect level” is the maximum concentration in a test which produces no observed adverse effects. A no-observed-effect level is expressed in terms of weight or volume of test...

  8. 40 CFR 798.4350 - Inhalation developmental toxicity study.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) HEALTH EFFECTS TESTING GUIDELINES Specific Organ/Tissue... million (ppm). (6) “No-observed-effect level” is the maximum concentration in a test which produces no observed adverse effects. A no-observed-effect level is expressed in terms of weight or volume of test...

  9. 40 CFR 798.4350 - Inhalation developmental toxicity study.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ...) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) HEALTH EFFECTS TESTING GUIDELINES Specific Organ/Tissue... million (ppm). (6) “No-observed-effect level” is the maximum concentration in a test which produces no observed adverse effects. A no-observed-effect level is expressed in terms of weight or volume of test...

  10. The Effects of Fatigue, Load Carriage, and Physical Activity History on Musculoskeletal Injury Mechanisms

    DTIC Science & Technology

    2013-09-01

    20kg, as described in the ACSM’s Guidelines for Exercise Testing and Prescription [3]. Two minutes of rest was given between trials. The assessment was...injuries during military training. Mil Med, 1999. 164(2): p. 153-6. 3. Thompson, W., ACSM’s Guidelines for Exercise Testing and Prescription. 2009...leads to cartilage degeneration and medial knee osteoarthritis (OA) [5,6,7]. Thus, the long- term effect of repetitive high varus knee loading could

  11. Diagnosis of Acute Gout: A Clinical Practice Guideline From the American College of Physicians.

    PubMed

    Qaseem, Amir; McLean, Robert M; Starkey, Melissa; Forciea, Mary Ann

    2017-01-03

    The American College of Physicians (ACP) developed this guideline to present the evidence and provide clinical recommendations on the diagnosis of gout. This guideline is based on a systematic review of published studies on gout diagnosis, identified using several databases, from database inception to February 2016. Evaluated outcomes included the accuracy of the test results; intermediate outcomes (results of laboratory and radiographic tests, such as serum urate and synovial fluid crystal analysis and radiographic or ultrasonography changes); clinical decision making (additional testing and pharmacologic or dietary management); short-term clinical (patient-centered) outcomes, such as pain and joint swelling and tenderness; and adverse effects of the tests. This guideline grades the evidence and recommendations by using the ACP grading system, which is based on the GRADE (Grading of Recommendations Assessment, Development and Evaluation) method. The target audience for this guideline includes all clinicians, and the target patient population includes adults with joint inflammation suspected to be gout. ACP recommends that clinicians use synovial fluid analysis when clinical judgment indicates that diagnostic testing is necessary in patients with possible acute gout. (Grade: weak recommendation, low-quality evidence).

  12. Test Analysis Guidelines

    NASA Technical Reports Server (NTRS)

    Jeng, Frank F.

    2007-01-01

    Development of analysis guidelines for Exploration Life Support (ELS) technology tests was completed. The guidelines were developed based on analysis experiences gained from supporting Environmental Control and Life Support System (ECLSS) technology development in air revitalization systems and water recovery systems. Analyses are vital during all three phases of the ELS technology test: pre-test, during test and post test. Pre-test analyses of a test system help define hardware components, predict system and component performances, required test duration, sampling frequencies of operation parameters, etc. Analyses conducted during tests could verify the consistency of all the measurements and the performance of the test system. Post test analyses are an essential part of the test task. Results of post test analyses are an important factor in judging whether the technology development is a successful one. In addition, development of a rigorous model for a test system is an important objective of any new technology development. Test data analyses, especially post test data analyses, serve to verify the model. Test analyses have supported development of many ECLSS technologies. Some test analysis tasks in ECLSS technology development are listed in the Appendix. To have effective analysis support for ECLSS technology tests, analysis guidelines would be a useful tool. These test guidelines were developed based on experiences gained through previous analysis support of various ECLSS technology tests. A comment on analysis from an experienced NASA ECLSS manager (1) follows: "Bad analysis was one that bent the test to prove that the analysis was right to begin with. Good analysis was one that directed where the testing should go and also bridged the gap between the reality of the test facility and what was expected on orbit."

  13. Missed connections: Unintended consequences of updated cervical cancer screening guidelines on screening rates for sexually transmitted infections.

    PubMed

    Bogler, Tali; Farber, Allison; Stall, Nathan; Wijayasinghe, Sheila; Slater, Morgan; Guiang, Charlie; Glazier, Richard H

    2015-10-01

    To examine the effects of the updated 2012 cervical cancer screening guidelines on the rates of sexually transmitted infection (STI) screening in primary care. Retrospective chart review. Five academic family practice units at St Michael's Hospital in Toronto, Ont. Female patients, aged 19 to 25, who had at least 1 visit with a physician at 1 of the 5 academic family practice units during a 12-month period before (May 1, 2011, to April 30, 2012) or after (November 1, 2012, to October 31, 2013) the release of the updated guidelines. Number of women who received Papanicolaou tests or underwent STI screening; rates of STI screening performed during a Pap test or a periodic health examination; screening rates for HIV, syphilis, and hepatitis C; and the methods used for STI screening before and after the release of the updated guidelines. Results Before the release of the 2012 guidelines, 42 of 100 women had Pap tests and 40 of 100 women underwent STI screening. After the release of the guidelines, 17 of 100 women had Pap tests and 20 of 100 women received STI screening. Female patients were less likely to undergo STI screening under the 2012 guidelines compared with the 2005 guidelines (odds ratio 0.38, 95% CI 0.19 to 0.74; P = .003). Implementation of the 2012 cervical cancer screening guidelines was associated with lower rates of STI screening in the primary care setting. Primary care physicians should screen at-risk women for STIs at any clinically appropriate encounter and consider using noninvasive self-sampling methods.

  14. Development and evaluation of online evidence based guideline bank system.

    PubMed

    Park, Myonghwa

    2006-01-01

    The purpose of this study was to develop and evaluate the online evidence-based nursing practice guideline bank system to support the best evidence-based decision in the clinical and community practice settings. The main homepage consisted of seven modules for introduction of site, EBN, guideline bank, guideline development, guideline review, related sites, and community. The major contents in the guidelines were purpose, developer, intended audience, method of development, target population, testing, knowledge components, and evaluation. Electronic versions of the guidelines were displayed by XML, PDF, and PDA versions. The system usability were evaluated by general users, guideline developers, and guideline reviewers on the web and the results showed high scores of satisfaction. This online evidence-based guideline bank system could support nurses' best and cost-effective clinical decision using the sharable standardized guidelines with education module of evidence based nursing.

  15. Nutrition practices of nurseries in England. Comparison with national guidelines☆

    PubMed Central

    Neelon, Sara E. Benjamin; Burgoine, Thomas; Hesketh, Kathryn R.; Monsivais, Pablo

    2015-01-01

    Recent national guidelines call for improved nutrition within early years settings. The aim of this cross-sectional study was to describe foods and beverages served in nurseries, assess provider behaviors related to feeding, and compare these practices to national guidelines. We administered a mailed survey to a random sample of nurseries across England, stratifying by tertile of deprivation. A total of 851 nurseries returned the survey (54.3% response rate). We fitted separate multivariate logistic regression models to estimate the association of deprivation with each of the 13 food and beverage guidelines and the seven provider behavior guidelines. We also conducted a joint F-test for any deprivation effect, to evaluate the effect of the guidelines combined. After adjusting for confounders, we observed differences in the frequency of nurseries that reported serving healthier foods across the tertiles of deprivation (p = 0.02 for joint F test). These adjusted results were driven mainly by nurseries in more deprived areas serving more whole grains (OR 1.57 (95% CI 1.00, 2.46)) and legumes, pulses, and lentils (1.40 (1.01, 2.14)). We also observed differences in the frequency of nurseries reporting more provider behaviors consistent with national guidelines across the tertiles of deprivation (p = 0.01 for joint F test). Nurseries in more deprived areas were more likely to dilute juice with water (2.35 (1.48, 3.73)), allow children to select their own portions (1.09 (1.06, 1.58)), and sit with children during meals (1.84 (1.07, 3.15)). While nurseries in the most deprived areas reported serving more healthy foods, a large percentage were still not meeting national guidelines. Policy and intervention efforts may increase compliance with national guidelines in nurseries in more deprived areas, and across England. PMID:25450898

  16. Research-Based Recommendations for the Use of Accommodations in Large-Scale Assessments: 2012 Update. Practical Guidelines for the Education of English Language Learners. Book 4

    ERIC Educational Resources Information Center

    Kieffer, Michael J.; Rivera, Mabel; Francis, David J.

    2012-01-01

    This report presents results from a new quantitative synthesis of research on the effectiveness and validity of test accommodations for English language learners (ELLs) taking large-scale assessments. In 2006, the Center on Instruction published a review of the literature on test accommodations for ELLs titled "Practical Guidelines for the…

  17. Publishing web-based guidelines using interactive decision models.

    PubMed

    Sanders, G D; Nease, R F; Owens, D K

    2001-05-01

    Commonly used methods for guideline development and dissemination do not enable developers to tailor guidelines systematically to specific patient populations and update guidelines easily. We developed a web-based system, ALCHEMIST, that uses decision models and automatically creates evidence-based guidelines that can be disseminated, tailored and updated over the web. Our objective was to demonstrate the use of this system with clinical scenarios that provide challenges for guideline development. We used the ALCHEMIST system to develop guidelines for three clinical scenarios: (1) Chlamydia screening for adolescent women, (2) antiarrhythmic therapy for the prevention of sudden cardiac death; and (3) genetic testing for the BRCA breast-cancer mutation. ALCHEMIST uses information extracted directly from the decision model, combined with the additional information from the author of the decision model, to generate global guidelines. ALCHEMIST generated electronic web-based guidelines for each of the three scenarios. Using ALCHEMIST, we demonstrate that tailoring a guideline for a population at high-risk for Chlamydia changes the recommended policy for control of Chlamydia from contact tracing of reported cases to a population-based screening programme. We used ALCHEMIST to incorporate new evidence about the effectiveness of implantable cardioverter defibrillators (ICD) and demonstrate that the cost-effectiveness of use of ICDs improves from $74 400 per quality-adjusted life year (QALY) gained to $34 500 per QALY gained. Finally, we demonstrate how a clinician could use ALCHEMIST to incorporate a woman's utilities for relevant health states and thereby develop patient-specific recommendations for BRCA testing; the patient-specific recommendation improved quality-adjusted life expectancy by 37 days. The ALCHEMIST system enables guideline developers to publish both a guideline and an interactive decision model on the web. This web-based tool enables guideline developers to tailor guidelines systematically, to update guidelines easily, and to make the underlying evidence and analysis transparent for users.

  18. Managing work-related psychological complaints by general practitioners, in coordination with occupational physicians: a pilot study.

    PubMed

    Buijs, Peter C; van Dijk, Frank J H; Evers, Marÿe; vd Klink, Jacques J L; Anema, Han

    2007-01-01

    Increasingly, workers have psychological work-related complaints, endangering their work ability and causing considerable economic losses. Many employees consult their general practitioner (GP). He, however, often pays insufficient attention to work-relatedness or to coordination with occupational physicians (OPs). Appropriate guidelines are missing. Consequently, we developed a GP guideline to handle these problems in coordination with OPs, and tested it in a pilot, using an explorative, evaluative study design. 23 GPs were trained to include employed patients and to test the guideline. Patients received questionnaires after 0, 4, 10 and 30 wk, GPs after 4 and 30 wk. The result was a new guideline, regarding problem orientation, diagnosis and advice, meant to avoid contradictory GP-OP advice and to activate patient responsibility. It included a GP-OP-patient communication form concerning information exchange and harmonization of insight/advice. Implementing GPs concluded that the guideline promotes recovery and work resumption and OP-GP contact benefits patients, prevents conflicting advice and promotes agreement on task division. They judged guideline efficiency and OP commitment less positively. Patients were positive, especially about GP-OP contact. Accordingly, an improved guideline, when tested for its effectiveness in a Randomized Controlled Trial, can help GPs to cope with a growing, complex problem, in collaboration with their occupational colleagues.

  19. The Moderating Effect of Job Satisfaction on Physicians' Motivation to Adhere to Financially Incentivized Clinical Practice Guidelines.

    PubMed

    Waddimba, Anthony C; Beckman, Howard B; Mahoney, Thomas L; Burgess, James F

    2017-04-01

    We examined moderating effects of professional satisfaction on physicians' motivation to adhere to diabetes guidelines associated with pay-for-performance incentives. We merged cross-sectional survey data on attitudes, from 156 primary physicians, with prospective medical record-sourced data on guideline adherence and census data on ambulatory-care population characteristics. We examined moderating effects by testing theory-driven models for satisfied versus discontented physicians, using partial least squares structural equation modeling. Results show that attitudes motivated, while norms suppressed, adherence to guidelines among discontented physicians. Separate models for satisfied versus discontented physicians revealed motivational differences. Satisfied physicians disregarded intrinsic and extrinsic influences and biases. Discontented physicians, alienated by social pressure, favored personal inclinations. To improve adherence to guidelines among discontented physicians, incentives should align with personal attitudes and incorporate promotional campaigns countering resentment of peer and organizational pressure.

  20. Nutrition practices of nurseries in England. Comparison with national guidelines.

    PubMed

    Neelon, Sara E Benjamin; Burgoine, Thomas; Hesketh, Kathryn R; Monsivais, Pablo

    2015-02-01

    Recent national guidelines call for improved nutrition within early years settings. The aim of this cross-sectional study was to describe foods and beverages served in nurseries, assess provider behaviors related to feeding, and compare these practices to national guidelines. We administered a mailed survey to a random sample of nurseries across England, stratifying by tertile of deprivation. A total of 851 nurseries returned the survey (54.3% response rate). We fitted separate multivariate logistic regression models to estimate the association of deprivation with each of the 13 food and beverage guidelines and the seven provider behavior guidelines. We also conducted a joint F-test for any deprivation effect, to evaluate the effect of the guidelines combined. After adjusting for confounders, we observed differences in the frequency of nurseries that reported serving healthier foods across the tertiles of deprivation (p = 0.02 for joint F test). These adjusted results were driven mainly by nurseries in more deprived areas serving more whole grains (OR 1.57 (95% CI 1.00, 2.46)) and legumes, pulses, and lentils (1.40 (1.01, 2.14)). We also observed differences in the frequency of nurseries reporting more provider behaviors consistent with national guidelines across the tertiles of deprivation (p = 0.01 for joint F test). Nurseries in more deprived areas were more likely to dilute juice with water (2.35 (1.48, 3.73)), allow children to select their own portions (1.09 (1.06, 1.58)), and sit with children during meals (1.84 (1.07, 3.15)). While nurseries in the most deprived areas reported serving more healthy foods, a large percentage were still not meeting national guidelines. Policy and intervention efforts may increase compliance with national guidelines in nurseries in more deprived areas, and across England. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

  1. Characterizing toxicity of metal-contaminated sediments from mining areas

    USGS Publications Warehouse

    Besser, John M.; Brumbaugh, William G.; Ingersoll, Christopher G.

    2015-01-01

    This paper reviews methods for testing the toxicity of metals associated with freshwater sediments, linking toxic effects with metal exposure and bioavailability, and developing sediment quality guidelines. The most broadly applicable approach for characterizing metal toxicity is whole-sediment toxicity testing, which attempts to simulate natural exposure conditions in the laboratory. Standard methods for whole-sediment testing can be adapted to test a wide variety of taxa. Chronic sediment tests that characterize effects on multiple endpoints (e.g., survival, growth, and reproduction) can be highly sensitive indicators of adverse effects on resident invertebrate taxa. Methods for testing of aqueous phases (pore water, overlying water, or elutriates) are used less frequently. Analysis of sediment toxicity data focuses on statistical comparisons between responses in sediments from the study area and responses in one or more uncontaminated reference sediments. For large or complex study areas, a greater number of reference sediments is recommended to reliably define the normal range of responses in uncontaminated sediments – the ‘reference envelope’. Data on metal concentrations and effects on test organisms across a gradient of contamination may allow development of concentration-response models, which estimate metal concentrations associated with specified levels of toxic effects (e.g. 20% effect concentration or EC20). Comparisons of toxic effects in laboratory tests with measures of impacts on resident benthic invertebrate communities can help document causal relationships between metal contamination and biological effects. Total or total-recoverable metal concentrations in sediments are the most common measure of metal contamination in sediments, but metal concentrations in labile sediment fractions (e.g., determined as part of selective sediment extraction protocols) may better represent metal bioavailability. Metals released by the weak-acid extraction of acid-volatile sulfide (AVS), termed simultaneously-extracted metals (SEM), are widely used to estimate the ‘potentially-bioavailable’ fraction of metals that is not bound to sulfides (i.e., SEM-AVS). Metal concentrations in pore water are widely considered to be direct measures of metal bioavailability, and predictions of toxicity based on pore-water metal concentrations may be further improved by modeling interactions of metals with other pore-water constituents using Biotic Ligand Models. Data from sediment toxicity tests and metal analyses has provided the basis for development of sediment quality guidelines, which estimate thresholds for toxicity of metals in sediments. Empirical guidelines such as Probable Effects Concentrations or (PECs) are based on associations between sediment metal concentrations and occurrence of toxic effects in large datasets. PECs do not model bioavailable metals, but they can be used to estimate the toxicity of metal mixtures using by calculation of probable effect quotients (PEQ = sediment metal concentration/PEC). In contrast, mechanistic guidelines, such as Equilibrium Partitioning Sediment Benchmarks (ESBs) attempt to predict both bioavailability and mixture toxicity. Application of these simple bioavailability models requires more extensive chemical characterization of sediments or pore water, compared to empirical guidelines, but may provide more reliable estimates of metal toxicity across a wide range of sediment types.

  2. Application of industry-standard guidelines for the validation of avionics software

    NASA Technical Reports Server (NTRS)

    Hayhurst, Kelly J.; Shagnea, Anita M.

    1990-01-01

    The application of industry standards to the development of avionics software is discussed, focusing on verification and validation activities. It is pointed out that the procedures that guide the avionics software development and testing process are under increased scrutiny. The DO-178A guidelines, Software Considerations in Airborne Systems and Equipment Certification, are used by the FAA for certifying avionics software. To investigate the effectiveness of the DO-178A guidelines for improving the quality of avionics software, guidance and control software (GCS) is being developed according to the DO-178A development method. It is noted that, due to the extent of the data collection and configuration management procedures, any phase in the life cycle of a GCS implementation can be reconstructed. Hence, a fundamental development and testing platform has been established that is suitable for investigating the adequacy of various software development processes. In particular, the overall effectiveness and efficiency of the development method recommended by the DO-178A guidelines are being closely examined.

  3. Evaluating an integrated approach to clinical quality improvement: clinical guidelines, quality measurement, and supportive system design.

    PubMed

    Cretin, S; Farley, D O; Dolter, K J; Nicholas, W

    2001-08-01

    Implementing clinical practice guidelines to change patient outcomes presents a challenge. Studies of single interventions focused on changing provider behavior demonstrate modest effects, suggesting that effective guideline implementation requires a multifaceted approach. Traditional biomedical research designs are not well suited to evaluating systems interventions. RAND and the Army Medical Department collaborated to develop and evaluate a system for implementing guidelines and documenting their effects on patient care. The evaluation design blended quality improvement, case study, and epidemiologic methods. A formative evaluation of implementation process and an outcome evaluation of patient impact were combined. Guidelines were implemented in 3 successive demonstrations targeting low back pain, asthma, and diabetes. This paper reports on the first wave of 4 facilities implementing a low back pain guideline. Organizational climate and culture, motivation, leadership commitment, and resources were assessed. Selected indicators of processes and outcomes of care were compared before, during, and after guideline implementation at the demonstration facilities and at comparison facilities. Logistic regression analysis was used to test for guideline effects on patient care. Process evaluation documented varied approaches to quality improvement across sites. Outcome evaluation revealed a significant downward trend in the percentage of acute low back pain patients referred to physical therapy or chiropractic care (10.7% to 7.2%) at demonstration sites and no such trend at control sites. Preliminary results suggest the power of this design to stimulate improvements in guideline implementation while retaining the power to evaluate rigorously effects on patient care.

  4. Enhancing implementation of tobacco use prevention and cessation counselling guideline among dental providers: a cluster randomised controlled trial.

    PubMed

    Amemori, Masamitsu; Korhonen, Tellervo; Kinnunen, Taru; Michie, Susan; Murtomaa, Heikki

    2011-02-14

    Tobacco use adversely affects oral health. Tobacco use prevention and cessation (TUPAC) counselling guidelines recommend that healthcare providers ask about each patient's tobacco use, assess the patient's readiness and willingness to stop, document tobacco use habits, advise the patient to stop, assist and help in quitting, and arrange monitoring of progress at follow-up appointments. Adherence to such guidelines, especially among dental providers, is poor. To improve guideline implementation, it is essential to understand factors influencing it and find effective ways to influence those factors. The aim of the present study protocol is to introduce a theory-based approach to diagnose implementation difficulties of TUPAC counselling guidelines among dental providers. Theories of behaviour change have been used to identify key theoretical domains relevant to the behaviours of healthcare providers involved in implementing clinical guidelines. These theoretical domains will inform the development of a questionnaire aimed at assessing the implementation of the TUPAC counselling guidelines among Finnish municipal dental providers. Specific items will be drawn from the guidelines and the literature on TUPAC studies. After identifying potential implementation difficulties, we will design two interventions using theories of behaviour change to link them with relevant behaviour change techniques aiming to improve guideline adherence. For assessing the implementation of TUPAC guidelines, the electronic dental record audit and self-reported questionnaires will be used. To improve guideline adherence, the theoretical-domains approach could provide a comprehensive basis for assessing implementation difficulties, as well as designing and evaluating interventions. After having identified implementation difficulties, we will design and test two interventions to enhance TUPAC guideline adherence. Using the cluster randomised controlled design, we aim to provide further evidence on intervention effects, as well as on the validity and feasibility of the theoretical-domain approach. The empirical data collected within this trial will be useful in testing whether this theoretical-domain approach can improve our understanding of the implementation of TUPAC guidelines among dental providers. Current Controlled Trials ISRCTN15427433.

  5. 40 CFR 799.9355 - TSCA reproduction/developmental toxicity screening test.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... toxicity screening test. 799.9355 Section 799.9355 Protection of Environment ENVIRONMENTAL PROTECTION... AND MIXTURE TESTING REQUIREMENTS Health Effects Test Guidelines § 799.9355 TSCA reproduction/developmental toxicity screening test. (a) Scope—(1) Applicability. This section is intended to meet testing...

  6. 40 CFR 799.9355 - TSCA reproduction/developmental toxicity screening test.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... toxicity screening test. 799.9355 Section 799.9355 Protection of Environment ENVIRONMENTAL PROTECTION... AND MIXTURE TESTING REQUIREMENTS Health Effects Test Guidelines § 799.9355 TSCA reproduction/developmental toxicity screening test. (a) Scope—(1) Applicability. This section is intended to meet testing...

  7. American College of Cardiology/American Heart Association preoperative assessment guidelines reduce resource utilization before aortic surgery.

    PubMed

    Froehlich, James B; Karavite, Dean; Russman, Pamela L; Erdem, Nurum; Wise, Chris; Zelenock, Gerald; Wakefield, Thomas; Stanley, James; Eagle, Kim A

    2002-10-01

    Methods used for evaluation of cardiac risk before noncardiac surgery vary widely. We evaluated the effect over time on practice and resource utilization of implementing the American College of Cardiology/American Heart Association Guidelines on Preoperative Risk Assessment. We compared 102 historical control patients who underwent elective abdominal aortic surgery (from January 1993 to December 1994) with 94 consecutive patients after guideline implementation (from July 1995 to December 1996) and 104 patients in a late after guideline implementation (from July 1, 1997, to September 30, 1998). Resource use (testing, revascularization, and costs) and outcomes (perioperative death and myocardial infarction) were examined. Patients with and without clinical markers of risk for perioperative cardiac complications were compared. The use of preoperative stress testing (88% to 47%; P <.00001), cardiac catheterization (24% to 11%; P <.05), and coronary revascularization (25% to 2%; P <.00001) decreased between control and postguideline groups, respectively. These changes persisted in the late postguideline group. Mean preoperative evaluation costs also fell ($1087 versus $171; P <.0001). Outcomes of death (4% versus 3% versus 2%) and myocardial infarction (7% versus 3% versus 5%) were not significantly different between control, postguideline, and late postguideline groups, respectively. Stress test rates were similar for patients at low risk versus high risk in the historical control group (84% versus 91%; P =.29) but lower for patients at low risk after guideline implementation (31% versus 61%; P =.003). Implementation of the American College of Cardiology/American Heart Association cardiac risk assessment guidelines appropriately reduced resource use and costs in patients who underwent elective aortic surgery without affecting outcomes. This effect was sustained 2 years after guideline implementation.

  8. European guidelines for workplace drug and alcohol testing in hair.

    PubMed

    Salomone, A; Tsanaclis, L; Agius, R; Kintz, P; Baumgartner, M R

    2016-10-01

    Guidelines for Legally Defensible Workplace Drug Testing have been prepared and updated by the European Workplace Drug Testing Society (EWDTS). They are based on the 2010 version published by Pascal Kintz and Ronald Agius (Guidelines for European workplace drug and alcohol testing in hair. Drug Test. Anal. 2010, 2, 367) and in concordance with the Society of Hair Testing guidelines (Society of Hair Testing guidelines for drug testing in hair. Forensic Sci. Int. 2012, 218, 20-24). The European Guidelines are designed to establish best practice procedures whilst allowing individual countries to operate within the requirements of national customs and legislation. The EWDTS recommends that all European laboratories that undertake legally defensible workplace drug testing use these guidelines as a template for accreditation. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  9. International Guidelines on Computer-Based and Internet-Delivered Testing

    ERIC Educational Resources Information Center

    International Journal of Testing, 2006

    2006-01-01

    Developed by the International Test Commission, the International Guidelines on Computer-Based and Internet-Delivered Testing are a set of guidelines specifically developed to highlight good practice issues in relation to computer/Internet tests and testing. These guidelines have been developed from an international perspective and are directed at…

  10. The effect of a rapid rehydration guideline on Emergency Department management of gastroenteritis in children.

    PubMed

    Waddell, Danielle; McGrath, Ian; Maude, Phil

    2014-07-01

    This study evaluated the use and effect of a rapid rehydration guideline for the management of gastroenteritis in children 6months to 4years of age in an Emergency Department (ED). The guideline aims to facilitate rehydration within 4h of arrival to the ED, using oral or nasogastric fluids. Primary outcome measures were ED Length of Stay (LOS) and hospital admission rates. Documentation of physiological recovery and consistency of re-hydration regimes used were examined as secondary outcomes. A quasi-experimental design using the medical records of 235 children pre and post intervention was used. Descriptive statistics (frequencies, medians, interquartile ranges) were used to summarize the data. The pre and post-test groups were compared using Chi Square and the Mann Whitney U Test. There was an increase in the ED LOS and in hospital admission rates post implementation of the rapid rehydration guideline in the ED. However, the time frame for initiation of rehydration therapy using oral or nasogastric routes improved post guideline implementation. The need for improvements in the ED management of dehydration secondary to gastroenteritis has been highlighted providing potential benefits to patient care and outcomes. Copyright © 2013 Elsevier Ltd. All rights reserved.

  11. Familial Hypercholesterolemia: A Systematic Review of Guidelines on Genetic Testing and Patient Management.

    PubMed

    Migliara, Giuseppe; Baccolini, Valentina; Rosso, Annalisa; D'Andrea, Elvira; Massimi, Azzurra; Villari, Paolo; De Vito, Corrado

    2017-01-01

    Familial hypercholesterolemia (FH) is an autosomal-dominant hereditary disorder of lipid metabolism that causes lifelong exposure to increased LDL levels resulting in premature coronary heart disease and, if untreated, death. Recent studies have shown its prevalence to be higher than previously considered, which has important implications for the mortality and morbidity of associated cardiovascular disease (CVD). Several clinical tools are used worldwide to help physicians diagnose FH, but nevertheless most patients remain undetected. This systematic review of guidelines aims to assess the role of genetic testing in the screening, diagnosis, and management of patients affected by heterozygous or homozygous FH and to identify related health-care pathways. We performed a systematic review of the literature; inclusion criteria were English or Italian guidelines focusing on genetic testing. The guidelines were included and evaluated for their content and development process using the Appraisal of Guidelines for Research and Evaluation II instrument. Ten guidelines were considered eligible, and all were judged to be of good quality, with slight differences among them. The most common indications for performing genetic tests were high levels of cholesterol, or physical findings consistent with lipid disorder, in the subject or in the family history. Subsequent screening of family members was indicated when a mutation had been identified in the index patient. Regarding patient management, the various guidelines agreed that intensive treatment with lipid-lowering medications should begin as quickly as possible and that lifestyle modifications should be an integral part of the therapy. Since the early detection of affected patients is beneficial for effective prevention of CVD, genetic testing is particularly useful for identifying family members via cascade screening and for distinguishing between heterozygous and homozygous individuals, the latter of which require more extreme therapeutic intervention.

  12. Guidelines for Design and Test of a Built-In Self Test (BIST) Circuit For Space Radiation Studies of High-Speed IC Technologies

    NASA Technical Reports Server (NTRS)

    Carts, M. A.; Marshall, P. W.; Reed, R.; Curie, S.; Randall, B.; LaBel, K.; Gilbert, B.; Daniel, E.

    2006-01-01

    Serial Bit Error Rate Testing under radiation to characterize single particle induced errors in high-speed IC technologies generally involves specialized test equipment common to the telecommunications industry. As bit rates increase, testing is complicated by the rapidly increasing cost of equipment able to test at-speed. Furthermore as rates extend into the tens of billions of bits per second test equipment ceases to be broadband, a distinct disadvantage for exploring SEE mechanisms in the target technologies. In this presentation the authors detail the testing accomplished in the CREST project and apply the knowledge gained to establish a set of guidelines suitable for designing arbitrarily high speed radiation effects tests.

  13. 40 CFR 799.11 - Availability of test guidelines.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 31 2010-07-01 2010-07-01 true Availability of test guidelines. 799.11... General Provisions § 799.11 Availability of test guidelines. (a) The TSCA and FIFRA guidelines for the...-487-4650). (b) The OECD guidelines for the various study plans are available from the following...

  14. Determinants of Practice Patterns and Quality Gaps in Lung Cancer Staging and Diagnosis

    PubMed Central

    Niu, Jiangong; Elting, Linda S.; Buchholz, Thomas A.; Giordano, Sharon H.

    2014-01-01

    Background: Guidelines recommend mediastinal lymph node sampling as the first invasive diagnostic procedure in patients with suspected lung cancer with mediastinal lymphadenopathy without distant metastases. Methods: Patients were a retrospective cohort of 15,316 patients with lung cancer with regional spread without metastatic disease in the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) or Texas Cancer Registry Medicare-linked databases. Patients were categorized based on the sequencing of invasive diagnostic tests performed: (1) evaluation consistent with guidelines, mediastinal sampling done first; (2) evaluation inconsistent with guidelines, non-small cell lung cancer (NSCLC) present, mediastinal sampling performed but not as part of the first invasive test; (3) evaluation inconsistent with guidelines, NSCLC present, mediastinal sampling never done; and (4) evaluation inconsistent with guidelines, small cell lung cancer. The primary outcome was whether guideline-consistent care was delivered. Secondary outcomes included whether patients with NSCLC ever had mediastinal sampling and use of transbronchial needle aspiration (TBNA) among pulmonologists. Results: Only 21% of patients had a diagnostic evaluation consistent with guidelines. Only 56% of patients with NSCLC had mediastinal sampling prior to treatment. There was significant regional variability in guideline-consistent care (range, 12%-29%). Guideline-consistent care was associated with lower patient age, metropolitan areas, and if the physician ordering or performing the test was male, trained in the United States, had seen more patients with lung cancer, and was a pulmonologist or thoracic surgeon who had graduated more recently. More recent pulmonary graduates were also more likely to perform TBNA (P < .001). Conclusions: Guideline-consistent care varied regionally and was associated with physician-level factors, suggesting that a lack of effective physician training may be contributing to the quality gaps observed. PMID:24202651

  15. 40 CFR 799.9537 - TSCA in vitro mammalian chromosome aberration test.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... aberration test. 799.9537 Section 799.9537 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... MIXTURE TESTING REQUIREMENTS Health Effects Test Guidelines § 799.9537 TSCA in vitro mammalian chromosome aberration test. (a) Scope—(1) Applicability. This section is intended to meet testing requirements under...

  16. Guideline attribute and implementation preferences among physicians in multiple health systems.

    PubMed

    Stone, Tamara T; Schweikhart, Sharon B; Mantese, Annamarie; Sonnad, Seema S

    2005-01-01

    Although practice guidelines are effective in assisting providers with clinical decision making, ineffective implementation strategies often prevent their use in practice. This study aimed to understand physician preferences for guideline format, placement, content, evidence, and learning strategies in different clinical environments. Semistructured telephone interviews were conducted with 500 randomly selected physicians from 4 major US health systems who were involved in the treatment of patients with acute myocardial infarction or pediatric asthma. Paired sample t tests and Tukey's method of comparisons determined the relative ranking of physicians' guideline implementation preferences. Physicians preferred guidelines located on the front of the patient chart, in palm pilots, or in progress notes and presented as flow charts/flow diagrams, algorithms, or preprinted orders that contain strategies to minimize readmits/encourage self-management and immediate treatment flows. Discussions with colleagues and continuing medical education are the most effective strategies for encouraging guideline use, and randomized controlled trials remain the most persuasive medical evidence. Health care organizations must align guideline implementation efforts with physician preferences to encourage utilization. The results of this study reveal systematic physician preferences for guideline implementation that can be applied to clinical settings to encourage guideline use by physicians.

  17. 75 FR 22400 - Draft Test Guidelines; Reopening of Comment Period

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-28

    ... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPP-2009-0681; FRL-8822-3] Draft Test Guidelines... draft test guidelines for product performance of public health uses of antimicrobial agents. EPA...-8437-2). In that document, EPA announced the availability of four draft test guidelines for product...

  18. 77 FR 15750 - Final Test Guidelines; OCSPP 810 Series; Notice of Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-16

    ... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPP-2009-0681; FRL-9332-4] Final Test Guidelines; OCSPP.... SUMMARY: EPA is announcing the availability of the final test guidelines for Series 810--Product Performance Test Guidelines, specifically public health uses of antimicrobial agents (OCSPP 810.2000...

  19. European guidelines for workplace drug testing in oral fluid.

    PubMed

    Brcak, Michaela; Beck, Olof; Bosch, Tessa; Carmichael, Duncan; Fucci, Nadia; George, Claire; Piper, Mark; Salomone, Alberto; Schielen, Wim; Steinmeyer, Stefan; Taskinen, Sanna; Weinmann, Wolfgang

    2018-03-01

    These guidelines for Legally Defensible Workplace Drug Testing have been prepared and updated by the European Workplace Drug Testing Society (EWDTS). The European Guidelines are designed to establish best practice procedures whilst allowing individual countries to operate within the requirements of national customs and legislation. The EWDTS recommends that all European laboratories that undertake legally defensible workplace drug testing should use these guidelines as a template for accreditation. These guidelines are relevant to laboratory-based testing only. These guidelines follow current best practices and are constantly under review. Copyright © 2017 John Wiley & Sons, Ltd.

  20. European guidelines for workplace drug testing in urine.

    PubMed

    Taskinen, Sanna; Beck, Olof; Bosch, Tessa; Brcak, Michaela; Carmichael, Duncan; Fucci, Nadia; George, Claire; Piper, Mark; Salomone, Alberto; Schielen, Wim; Steinmeyer, Stefan; Weinmann, Wolfgang

    2017-06-01

    These European Guidelines for Workplace Drug Testing in Urine have been prepared and updated by the European Workplace Drug Testing Society (EWDTS). The first version of these urine guidelines was published in 2002. Since then, the guidelines have been followed by many laboratories in different European countries and their role has been essential particularly in countries lacking legislation for workplace drug testing. In 2014, the EWDTS started a guidelines updating project and published a new version of the urine guidelines in 2015. Here we represent this updated version of the urine guidelines. The European Guidelines are designed to establish best practice procedures whilst allowing individual countries to operate within the requirements of national customs and legislation. The EWDTS recommends that all European laboratories that undertake legally defensible workplace drug testing should use these guidelines as a template for accreditation. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

  1. The Selection of Air Traffic Control Specialists: I. History and Review of Contributions by the Civil Aeromedical Institute,

    DTIC Science & Technology

    1980-06-01

    were relatively young (22). However, such proposed policies ran counter to the CSC regulations pertaining to all Federal service employees except those...to exclude minorities. In 1966, the Equal Employment Opportunity Commission ( EEOC ) adopted guidelines that stated that the employer’s intent was...irrelevant if exclusion of minorities was the net effect of using certain tests. The EEOC guidelines declared a test unlawful for use in employee

  2. How meaningful are risk determinations in the absence of a complete dataset? Making the case for publishing standardized test guideline and 'no effect' studies for evaluating the safety of nanoparticulates versus spurious 'high effect' results from single investigative studies.

    PubMed

    Warheit, David B; Donner, E Maria

    2015-06-01

    A recent review article critically assessed the effectiveness of published research articles in nanotoxicology to meaningfully address health and safety issues for workers and consumers. The main conclusions were that, based on a number of flaws in study designs, the potential risk from exposures to nanomaterials is highly exaggerated, and that no 'nano-specific' adverse effects, different from exposures to bulk particles, have been convincingly demonstrated. In this brief editorial we focus on a related tangential issue which potentially compromises the integrity of basic risk science. We note that some single investigation studies report specious toxicity findings, which make the conclusions more alarming and attractive and publication worthy. In contrast, the standardized, carefully conducted, 'guideline study results' are often ignored because they can frequently report no adverse effects; and as a consequence are not considered as novel findings for publication purposes, and therefore they are never considered as newsworthy in the popular press. Yet it is the Organization for Economic Cooperation and Development (OECD) type test guideline studies that are the most reliable for conducting risk assessments. To contrast these styles and approaches, we present the results of a single study which reports high toxicological effects in rats following low-dose, short-term oral exposures to nanoscale titanium dioxide particles concomitant with selective investigative analyses. Alternatively, the findings of OECD test guideline 408, standardized guideline oral toxicity studies conducted for 90 days at much higher doses (1000 mg kg -1 ) in male and female rats demonstrated no adverse effects following a very thorough and complete clinical chemical, as well as histopathological evaluation of all of the relevant organs in the body. This discrepancy in study findings is not reconciled by the fact that several biokinetic studies in rats and humans demonstrate little or no uptake of nanoscale or pigment-grade TiO 2 particles following oral exposures. We conclude that to develop a competent risk assessment profile, results derived from standardized, guideline-type studies, and even 'no effect' study findings provide critically useful input for assessing safe levels of exposure; and should, in principle, be readily acceptable for publication in peer-reviewed toxicology journals. This is a necessary prerequisite for developing a complete dataset for risk assessment determinations.

  3. Guidelines for Proof Test Analysis

    NASA Technical Reports Server (NTRS)

    Chell, G. G.; McClung, R. C.; Kuhlman, C. J.; Russell, D. A.; Garr, K.; Donnelly, B.

    1999-01-01

    These guidelines integrate state-of-the-art elastic-plastic fracture mechanics (EPFM) and proof test implementation issues into a comprehensive proof test analysis procedure in the form of a road map which identifies the types of data, fracture mechanics based parameters, and calculations needed to perform flaw screening and minimum proof load analyses of fracture critical components. Worked examples are presented to illustrate the application of the road map to proof test analysis. The state-of-the art fracture technology employed in these guidelines is based on the EPFM parameter, J, and a pictorial representation of a J fracture analysis, called the failure assessment diagram (FAD) approach. The recommended fracture technology is validated using finite element J results, and laboratory and hardware fracture test results on the nickel-based superalloy Inconel 718, the aluminum alloy 2024-T3511, and ferritic pressure vessel steels. In all cases the laboratory specimens and hardware failed by ductile mechanisms. Advanced proof test analyses involving probability analysis and multiple-cycle proof testing (MCPT) are addressed. Finally, recommendations are provided on how to account for the effects of the proof test overload on subsequent service fatigue and fracture behaviors.

  4. Validation of the OECD reproduction test guideline with the New Zealand mudsnail Potamopyrgus antipodarum using trenbolone and prochloraz.

    PubMed

    Geiß, Cornelia; Ruppert, Katharina; Askem, Clare; Barroso, Carlos; Faber, Daniel; Ducrot, Virginie; Holbech, Henrik; Hutchinson, Thomas H; Kajankari, Paula; Kinnberg, Karin Lund; Lagadic, Laurent; Matthiessen, Peter; Morris, Steve; Neiman, Maurine; Penttinen, Olli-Pekka; Sanchez-Marin, Paula; Teigeler, Matthias; Weltje, Lennart; Oehlmann, Jörg

    2017-04-01

    The Organisation for Economic Cooperation and Development (OECD) provides several standard test methods for the environmental hazard assessment of chemicals, mainly based on primary producers, arthropods, and fish. In April 2016, two new test guidelines with two mollusc species representing different reproductive strategies were approved by OECD member countries. One test guideline describes a 28-day reproduction test with the parthenogenetic New Zealand mudsnail Potamopyrgus antipodarum. The main endpoint of the test is reproduction, reflected by the embryo number in the brood pouch per female. The development of a new OECD test guideline involves several phases including inter-laboratory validation studies to demonstrate the robustness of the proposed test design and the reproducibility of the test results. Therefore, a ring test of the reproduction test with P. antipodarum was conducted including eight laboratories with the test substances trenbolone and prochloraz and results are presented here. Most laboratories could meet test validity criteria, thus demonstrating the robustness of the proposed test protocol. Trenbolone did not have an effect on the reproduction of the snails at the tested concentration range (nominal: 10-1000 ng/L). For prochloraz, laboratories produced similar EC 10 and NOEC values, showing the inter-laboratory reproducibility of results. The average EC 10 and NOEC values for reproduction (with coefficient of variation) were 26.2 µg/L (61.7%) and 29.7 µg/L (32.9%), respectively. This ring test shows that the mudsnail reproduction test is a well-suited tool for use in the chronic aquatic hazard and risk assessment of chemicals.

  5. Use of a time series design to test effectiveness of a theory-based intervention targeting adherence of health professionals to a clinical guideline.

    PubMed

    Hanbury, Andria; Wallace, Louise; Clark, Michael

    2009-09-01

    The aim of this study was to test the effectiveness of a theory of planned behaviour intervention to increase adherence of community mental health professionals to a national suicide prevention guideline. Routinely collected audit adherence data from an intervention and control site were collected and analysed using time series analysis to test whether the intervention significantly increased adherence. The effects of a local and national event on adherence were also examined. A Theory of Planned Behaviour (TPB) questionnaire, developed from interview findings, was administered to the health professionals. Subjective norms were found to be the most significant predictor of intention to adhere to the guideline, and were targeted with an interactive educational intervention. Time series analysis applied to routinely collected audit adherence data was used to test intervention effectiveness. The TPB accounted for 58% of the variance in intention to adhere, with subjective norms the only significant predictor. The intervention did not significantly increase adherence; however, the national and local events were found to have significantly increased adherence. The TPB was a useful framework for exploring barriers to adherence; however, this did not translate into an effective intervention. Future research should seek collaboration with local experts, and use this information in combination with the TPB, to develop interventions. Collaborative research with experts in pedagogy may also help to develop more effective interventions, particularly education-based interventions that require adult learning.

  6. Systems consultation: protocol for a novel implementation strategy designed to promote evidence-based practice in primary care.

    PubMed

    Quanbeck, Andrew; Brown, Randall T; E Zgierska, Aleksandra; A Johnson, Roberta; Robinson, James M; Jacobson, Nora

    2016-01-27

    Adoption of evidence-based practices takes place at a glacial place in healthcare. This research will pilot test an innovative implementation strategy - systems consultation -intended to speed the adoption of evidence-based practice in primary care. The strategy is based on tenets of systems engineering and has been extensively tested in addiction treatment. Three innovations have been included in the strategy - translation of a clinical practice guideline into a checklist-based implementation guide, the use of physician peer coaches ('systems consultants') to help clinics implement the guide, and a focus on reducing variation in practices across prescribers and clinics. The implementation strategy will be applied to improving opioid prescribing practices in primary care, which may help ultimately mitigate the increasing prevalence of opioid abuse and addiction. The pilot test will compare four intervention clinics to four control clinics in a matched-pairs design. A leading clinical guideline for opioid prescribing has been translated into a checklist-based implementation guide in a systematic process that involved experts who wrote the guideline in consultation with implementation experts and primary care physicians. Two physicians with expertise in family and addiction medicine are serving as the systems consultants. Each systems consultant will guide two intervention clinics, using two site visits and follow-up communication by phone and email, to implement the translated guideline. Mixed methods will be used to test the feasibility, acceptability, and preliminary effectiveness of the implementation strategy in an evaluation that meets standards for 'fully developed use' of the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, Maintenance). The clinic will be the primary unit of analysis. The systems consultation implementation strategy is intended to generalize to the adoption of other clinical guidelines. This pilot test is intended to prepare for a large randomized clinical trial that will test the strategy against other implementation strategies, such as audit/feedback and academic detailing, used to close the gap between knowledge and practice. The systems consultation approach has the potential to shorten the famously long time it takes to implement evidence-based practices and clinical guidelines in healthcare.

  7. Cost-Effectiveness of High-Risk Human Papillomavirus Testing With Messenger RNA Versus DNA Under United States Guidelines for Cervical Cancer Screening.

    PubMed

    Ting, Jie; Smith, Jennifer S; Myers, Evan R

    2015-10-01

    To compare the cost-effectiveness of high-risk human papillomavirus (hrHPV) testing using a hrHPV DNA and a hrHPV messenger RNA (mRNA) assay under current US cervical cancer screening guidelines. We constructed a Markov model for stochastic cost-effectiveness analysis using published data. We compared screening efficiency using DNA and mRNA testing for the following: (1) cotesting with cytology in women 30 to 65 years, and (2) triage of women with mild cervical cytological abnormalities (atypical squamous cells of undetermined significance [ASC-US]) in the United States. Screening end point is histologically confirmed high-grade lesions (cervical intraepithelial neoplasia grade 2, 3, or invasive cancer). Sensitivity and specificity estimates of DNA and mRNA testing to detect cervical intraepithelial neoplasia grade 2, 3, or invasive cancer were obtained from 2 published trials: the US Clinical Evaluation of APTIMA mRNA (CLEAR) study for ASC-US triage and the French APTIMA Screening Evaluation (FASE) study for cotesting. Costs of DNA and mRNA testing were assumed identical. Costs of screening, diagnosis, and treatment of cervical neoplasia and cancer were from previously published estimates, adjusted to 2012 US dollars. Inputs were modeled as distributions for Monte Carlo probabilistic sensitivity analysis. Model outcomes were costs per life-year saved for each strategy, discounted at 3% annually. For both cotesting and ASC-US triage, mRNA testing cost less than DNA testing, whereas life expectancies were widely overlapping. There was a 100% probability that DNA testing was not cost-effective at $100,000/life-year saved threshold for ASC-US triage and a 55% probability that DNA testing was not cost-effective at the same threshold for cotesting. Based on the available evidence, mRNA testing for cotesting or ASC-US triage is likely to be more efficient than DNA testing under current US cervical cancer screening guidelines.

  8. Incidence of Exposure of Patients in the United States to Multiple Drugs for Which Pharmacogenomic Guidelines Are Available.

    PubMed

    Samwald, Matthias; Xu, Hong; Blagec, Kathrin; Empey, Philip E; Malone, Daniel C; Ahmed, Seid Mussa; Ryan, Patrick; Hofer, Sebastian; Boyce, Richard D

    2016-01-01

    Pre-emptive pharmacogenomic (PGx) testing of a panel of genes may be easier to implement and more cost-effective than reactive pharmacogenomic testing if a sufficient number of medications are covered by a single test and future medication exposure can be anticipated. We analysed the incidence of exposure of individual patients in the United States to multiple drugs for which pharmacogenomic guidelines are available (PGx drugs) within a selected four-year period (2009-2012) in order to identify and quantify the incidence of pharmacotherapy in a nation-wide patient population that could be impacted by pre-emptive PGx testing based on currently available clinical guidelines. In total, 73 024 095 patient records from private insurance, Medicare Supplemental and Medicaid were included. Patients enrolled in Medicare Supplemental age > = 65 or Medicaid age 40-64 had the highest incidence of PGx drug use, with approximately half of the patients receiving at least one PGx drug during the 4 year period and one fourth to one third of patients receiving two or more PGx drugs. These data suggest that exposure to multiple PGx drugs is common and that it may be beneficial to implement wide-scale pre-emptive genomic testing. Future work should therefore concentrate on investigating the cost-effectiveness of multiplexed pre-emptive testing strategies.

  9. Draft Test Guideline: Daphnid Chronic Toxicity Test

    EPA Pesticide Factsheets

    The following draft test guideline is part of a series of test guidelines that have been developed by EPA for use in the testing of pesticides and toxic substances, and the development of test data for submission to the Agency for review.

  10. Draft Test Guideline: Gammarid Acute Toxicity Test

    EPA Pesticide Factsheets

    The following draft test guideline is part of a series of test guidelines that have been developed by EPA for use in the testing of pesticides and toxic substances, and the development of test data for submission to the Agency for review.

  11. Draft Test Guideline: Chironomid Sediment Toxicity Test

    EPA Pesticide Factsheets

    The following draft test guideline is part of a series of test guidelines that have been developed by EPA for use in the testing of pesticides and toxic substances, and the development of test data for submission to the Agency for review.

  12. Draft Test Guideline: Mysid Acute Toxicity Test

    EPA Pesticide Factsheets

    The following draft test guideline is part of a series of test guidelines that have been developed by EPA for use in the testing of pesticides and toxic substances, and the development of test data for submission to the Agency for review.

  13. Draft Test Guideline: Penaeid Acute Toxicity Test

    EPA Pesticide Factsheets

    The following draft test guideline is part of a series of test guidelines that have been developed by EPA for use in the testing of pesticides and toxic substances, and the development of test data for submission to the Agency for review.

  14. Draft Test Guideline: Mysid Chronic Toxicity Test

    EPA Pesticide Factsheets

    The following draft test guideline is part of a series of test guidelines that have been developed by EPA for use in the testing of pesticides and toxic substances, and the development of test data for submission to the Agency for review.

  15. Health Economic Evaluation of a Strict Glucose Control Guideline Implemented Using Point-of-Care Testing in Three Intensive Care Units in The Netherlands.

    PubMed

    van Hooijdonk, Roosmarijn T M; Steuten, Lotte M G; Kip, Michelle M A; Monteban, Helma; Mulder, Marianne R; van Braam Houckgeest, Floris; van der Sluijs, Johannes P; Abu-Hanna, Ameen; Spronk, Peter E; Schultz, Marcus J

    2015-08-01

    Point-of-care testing of blood glucose (BG-POCT) is essential for safe and effective insulin titrations in critically ill patients under glucose control with insulin. The costs associated with this practice are considered substantial, especially when more frequent blood glucose (BG) testing is needed, as with more strict glucose control (SGC) aiming for lower BG levels. The objective of this study was to estimate, from a hospital perspective, the incremental cost effectiveness of an SGC guideline, aiming for BG levels of 4.4-6.1 mmol/L, compared to the situation before implementation of that guideline (aiming for BG levels <8.3 mmol/L), both using BG-POCT. This is a secondary analysis of a guideline implementation project aiming for implementation of a guideline of SGC in three intensive care units in The Netherlands. A Markov model including the four health states 'target glucose', 'hyperglycaemia' (defined as BG levels >6.1 mmol/L), 'hypoglycaemia' (defined as BG levels <4.4 mmol/L) and 'in-hospital death' was developed to compare expected costs, number of patients within target and number of life-years saved before and after implementation of the SGC guideline. The effectiveness estimates are based on empirical data from 3195 patients 12 and 24 months before and after implementation of the guideline, respectively. All costs have been converted to price year 2013, and are estimated based on hospital data, the literature and available price lists. The number of BG-POCT increased from 4.8 [interquartile range (IQR) 2.6-6.7] to 8.0 [IQR 4.1-11.2] per patient per day, accruing 58% higher costs for BG-POCT (€13.56 vs. €8.57 per patient) in the SGC protocol versus the situation before implementation. When taking total hospital costs and clinical effects into account, implementation of the SGC guideline increased total hospital costs per patient by 1.8%, i.e., €355 (from €20,617 to €20,972) during the inpatient stay, while the number of patients in target glucose levels increased by 1.4% (i.e., from 881 to 895 per 1000 patients). This translates to an incremental cost-effectiveness ratio of €25 per additional patient within the target glucose level. The model outcomes are most sensitive to changes in ICU length of stay. The increase in the number of patients and time within target glucose levels is achieved with a small increase in total direct hospital costs.

  16. [Ethical guidelines on genetic testing and gene therapy].

    PubMed

    Fukushima, Yoshimitsu

    2005-03-01

    According to the recent and rapid advances in molecular genetics research, genetic testing and gene therapy have a potential of giving unexpected influence to the human beings. To prevent and to solve various ethical, legal and social implementations (ELSI) of genetic testing and gene therapy, several guidelines have been established. In Japan, all researchers and all clinicians have to know and keep the following three guidelines on genetic testing and a guideline on gene therapy: 1) "Guidelines for Researches on Human Genome and Gene (2001)" by the three Ministries (Education, Health and Economy), 2) "Guidelines for Genetic Testing (2001)" by the Genetic--medicine--related 10 societies, 3) "Ethical Principles on Entrusted Genetic Testing (2001)" by the Japan Registered Clinical Laboratories Association, and 4) "Guidelines for Clinical Research on Gene Therapy (2002)" by the two Ministries (Health and Education).

  17. Effect of soil properties on the toxicity of Pb: assessment of the appropriateness of guideline values.

    PubMed

    Romero-Freire, A; Martin Peinado, F J; van Gestel, C A M

    2015-05-30

    Soil contamination with lead is a worldwide problem. Pb can cause adverse effects, but its mobility and availability in the terrestrial environment are strongly controlled by soil properties. The present study investigated the influence of different soil properties on the solubility of lead in laboratory spiked soils, and its toxicity in three bioassays, including Lactuca sativa root elongation and Vibrio fischeri illumination tests applied to aqueous extracts and basal soil respiration assays. Final aim was to compare soil-dependent toxicity with guideline values. The L. sativa bioassay proved to be more sensitive to Pb toxicity than the V. fischeri and soil respiration tests. Toxicity was significantly correlated with soil properties, with soil pH, carbonate and organic carbon content being the most important factors. Therefore, these variables should be considered when defining guideline values. Copyright © 2015 Elsevier B.V. All rights reserved.

  18. Draft Test Guideline: Tadpole/Sediment Subchronic Toxicity Test

    EPA Pesticide Factsheets

    The following draft test guideline is part of a series of test guidelines that have been developed by EPA for use in the testing of pesticides and toxic substances, and the development of test data for submission to the Agency for review.

  19. Draft Test Guideline: Bivalve Acute Toxicity Test (Embryo Larval)

    EPA Pesticide Factsheets

    The following draft test guideline is part of a series of test guidelines that have been developed by EPA for use in the testing of pesticides and toxic substances, and the development of test data for submission to the Agency for review.

  20. Draft Test Guideline: Field Testing For Aquatic Organisms

    EPA Pesticide Factsheets

    The following draft test guideline is part of a series of test guidelines that have been developed by EPA for use in the testing of pesticides and toxic substances, and the development of test data for submission to the Agency for review.

  1. Draft Test Guideline: Oyster Acute Toxicity Test (Shell Deposition)

    EPA Pesticide Factsheets

    The following draft test guideline is part of a series of test guidelines that have been developed by EPA for use in the testing of pesticides and toxic substances, and the development of test data for submission to the Agency for review.

  2. Draft Test Guideline: Site-Specific Aquatic Microcosm Test, Laboratory

    EPA Pesticide Factsheets

    The following draft test guideline is part of a series of test guidelines that have been developed by EPA for use in the testing of pesticides and toxic substances, and the development of test data for submission to the Agency for review.

  3. Draft Test Guideline: Generic Freshwater Microcosm Test, Laboratory

    EPA Pesticide Factsheets

    The following draft test guideline is part of a series of test guidelines that have been developed by EPA for use in the testing of pesticides and toxic substances, and the development of test data for submission to the Agency for review.

  4. Draft Test Guideline: Fish Early-Life Stage Toxicity Test

    EPA Pesticide Factsheets

    The following draft test guideline is part of a series of test guidelines that have been developed by EPA for use in the testing of pesticides and toxic substances, and the development of test data for submission to the Agency for review.

  5. Enhancing implementation of tobacco use prevention and cessation counselling guideline among dental providers: a cluster randomised controlled trial

    PubMed Central

    2011-01-01

    Background Tobacco use adversely affects oral health. Tobacco use prevention and cessation (TUPAC) counselling guidelines recommend that healthcare providers ask about each patient's tobacco use, assess the patient's readiness and willingness to stop, document tobacco use habits, advise the patient to stop, assist and help in quitting, and arrange monitoring of progress at follow-up appointments. Adherence to such guidelines, especially among dental providers, is poor. To improve guideline implementation, it is essential to understand factors influencing it and find effective ways to influence those factors. The aim of the present study protocol is to introduce a theory-based approach to diagnose implementation difficulties of TUPAC counselling guidelines among dental providers. Methods Theories of behaviour change have been used to identify key theoretical domains relevant to the behaviours of healthcare providers involved in implementing clinical guidelines. These theoretical domains will inform the development of a questionnaire aimed at assessing the implementation of the TUPAC counselling guidelines among Finnish municipal dental providers. Specific items will be drawn from the guidelines and the literature on TUPAC studies. After identifying potential implementation difficulties, we will design two interventions using theories of behaviour change to link them with relevant behaviour change techniques aiming to improve guideline adherence. For assessing the implementation of TUPAC guidelines, the electronic dental record audit and self-reported questionnaires will be used. Discussion To improve guideline adherence, the theoretical-domains approach could provide a comprehensive basis for assessing implementation difficulties, as well as designing and evaluating interventions. After having identified implementation difficulties, we will design and test two interventions to enhance TUPAC guideline adherence. Using the cluster randomised controlled design, we aim to provide further evidence on intervention effects, as well as on the validity and feasibility of the theoretical-domain approach. The empirical data collected within this trial will be useful in testing whether this theoretical-domain approach can improve our understanding of the implementation of TUPAC guidelines among dental providers. Trial registration Current Controlled Trials ISRCTN15427433 PMID:21320312

  6. Comparison of biodegradation performance of OECD test guideline 301C with that of other ready biodegradability tests.

    PubMed

    Kayashima, Takakazu; Taruki, Masanori; Katagiri, Kazuomi; Nabeoka, Ryosuke; Yoshida, Tomohiko; Tsuji, Toshiaki

    2014-02-01

    The Organisation for Economic Co-operatoin and development (OECD) Guidelines for the Testing of Chemicals list 7 types of tests for determining the ready biodegradability of chemical compounds (301A-F and 310). The present study compares the biodegradation performance of test guideline 301C, which is applied in Japan's Chemical Substances Control Law, with the performance of the other 6 ready biodegradability tests (RBTs) listed in the guidelines. Test guideline 301C specifies use of activated sludge precultured with synthetic sewage containing glucose and peptone (301C sludge) as a test inoculum; in the other RBTs, however, activated sludge from wastewater treatment plants (WWTP sludge) is frequently employed. Analysis based on percentage of biodegradation and pass levels revealed that the biodegradation intensity of test guideline 301C is relatively weak compared with the intensities of RBTs using WWTP sludge, and the following chemical compounds are probably not biodegraded under test guideline 301C conditions: phosphorus compounds; secondary, tertiary, and quaternary amines; and branched quaternary carbon compounds. The relatively weak biodegradation intensity of test guideline 301C may be related to the markedly different activities of the 301C and WWTP sludges. These findings will be valuable for evaluating RBT data in relation to Japan's Chemical Substances Control Law. © 2013 SETAC.

  7. 40 CFR 799.9510 - TSCA bacterial reverse mutation test.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 32 2014-07-01 2014-07-01 false TSCA bacterial reverse mutation test... REQUIREMENTS Health Effects Test Guidelines § 799.9510 TSCA bacterial reverse mutation test. (a) Scope. This... mutation test uses amino-acid requiring strains of Salmonella typhimurium and Escherichia coli to detect...

  8. Draft Test Guideline: Aquatic Invetebrate Acute Toxicity, Test, Freshwater Daphnids

    EPA Pesticide Factsheets

    The following draft test guideline is part of a series of test guidelines that have been developed by EPA for use in the testing of pesticides and toxic substances, and the development of test data for submission to the Agency for review.

  9. Draft Test Guideline: Fish Acute Toxicity Test, Freshwater And Marine

    EPA Pesticide Factsheets

    The following draft test guideline is part of a series of test guidelines that have been developed by EPA for use in the testing of pesticides and toxic substances, and the development of test data for submission to the Agency for review.

  10. Grading evidence from test accuracy studies: what makes it challenging compared with the grading of effectiveness studies?

    PubMed

    Rogozińska, Ewelina; Khan, Khalid

    2017-06-01

    Guideline panels need to process a sizeable amount of information to issue a decision on whether to recommend a health technology or not. Grading of Recommendations Assessment, Development, and Evaluation (GRADE) is being frequently applied in guideline development to facilitate this task, typically for the synthesis of effectiveness research. Questions regarding the accuracy of medical tests are ubiquitous, and they temporally precede questions about therapy. However, literature summarising the experience of applying GRADE approach to accuracy evaluations is not as rich as one for effectiveness evidence. Type of study design (cross-sectional), two-dimensional nature of the performance measures (sensitivity and specificity), propensity towards a higher level of between-study heterogeneity, poor reporting of quality features and uncertainty about how best to assess for publication bias among other features make this task challenging. This article presents solutions adopted to addresses above challenges for judicious estimation of the strength of test accuracy evidence used to inform evidence syntheses for guideline development. © 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.

  11. Testing biological effects of hand-washing grey water for reuse in irrigation on an urban farm: a case study.

    PubMed

    Khan, Mohammad Zain; Sim, Yei Lin; Lin, Yang Jian; Lai, Ka Man

    2013-01-01

    The feasibility of reusing hand-washing grey water contaminated with antibacterial hand-washing liquid for irrigation purposes in an urban farm is explored in this case study. Experiments are carried out to investigate if the quality of this grey water allows for its reuse in agriculture as per the guidelines established by the World Health Organization (WHO). However, there is no guideline to test the biological effect of grey water prior to agricultural use. It is plausible that the antibacterial property of the grey water can harm the soil microbial system and plants when applied to land, even if all other water quality parameters satisfy the WHO limit. We use algae (Chlorella vulgaris) and indigenous soil bacteria as initial plant and soil bacteria indicators, respectively, to test the potential inhibition of the water on plants and soil bacteria. Results show that the chemical oxygen demand (COD) of the grey water is 10% higher than the WHO permissible level, while all other water quality parameters are within the limits after four days of our experimental period. An inhibitory effect is observed in all of the biological tests. However, the inhibitory effect on algae and soil bacteria is not observed after the four-day period. The case study demonstrates a new approach for testing the biological effect of grey water, which can be used in conjunction with the WHO guideline, and provides data for this urban farm to set up a future water treatment system for grey-water reuse in irrigation.

  12. Draft Test Guideline: Fish Bioconcentration Factor (BCF)

    EPA Pesticide Factsheets

    The following draft test guideline is part of a series of test guidelines that have been developed by EPA for use in the testing of pesticides and toxic substances, and the development of test data for submission to the Agency for review.

  13. Draft Test Guideline: Oyster Bioconcentration Factor (BCF)

    EPA Pesticide Factsheets

    The following draft test guideline is part of a series of test guidelines that have been developed by EPA for use in the testing of pesticides and toxic substances, and the development of test data for submission to the Agency for review.

  14. Draft Test Guideline: Fish Life Cycle Toxicity

    EPA Pesticide Factsheets

    The following draft test guideline is part of a series of test guidelines that have been developed by EPA for use in the testing of pesticides and toxic substances, and the development of test data for submission to the Agency for review.

  15. Draft Test Guideline: Aquatic Food Chain Transfer

    EPA Pesticide Factsheets

    The following draft test guideline is part of a series of test guidelines that have been developed by EPA for use in the testing of pesticides and toxic substances, and the development of test data for submission to the Agency for review.

  16. Evaluation of the theory-based Quality Improvement in Physical Therapy (QUIP) programme: a one-group, pre-test post-test pilot study

    PubMed Central

    2013-01-01

    Background Guideline adherence in physical therapy is far from optimal, which has consequences for the effectiveness and efficiency of physical therapy care. Programmes to enhance guideline adherence have, so far, been relatively ineffective. We systematically developed a theory-based Quality Improvement in Physical Therapy (QUIP) programme aimed at the individual performance level (practicing physiotherapists; PTs) and the practice organization level (practice quality manager; PQM). The aim of the study was to pilot test the multilevel QUIP programme’s effectiveness and the fidelity, acceptability and feasibility of its implementation. Methods A one-group, pre-test, post-test pilot study (N = 8 practices; N = 32 PTs, 8 of whom were also PQMs) done between September and December 2009. Guideline adherence was measured using clinical vignettes that addressed 12 quality indicators reflecting the guidelines’ main recommendations. Determinants of adherence were measured using quantitative methods (questionnaires). Delivery of the programme and management changes were assessed using qualitative methods (observations, group interviews, and document analyses). Changes in adherence and determinants were tested in the paired samples T-tests and expressed in effect sizes (Cohen’s d). Results Overall adherence did not change (3.1%; p = .138). Adherence to three quality indicators improved (8%, 24%, 43%; .000 ≤ p ≤ .023). Adherence to one quality indicator decreased (−15.7%; p = .004). Scores on various determinants of individual performance improved and favourable changes at practice organizational level were observed. Improvements were associated with the programme’s multilevel approach, collective goal setting, and the application of self-regulation; unfavourable findings with programme deficits. The one-group pre-test post-test design limits the internal validity of the study, the self-selected sample its external validity. Conclusions The QUIP programme has the potential to change physical therapy practice but needs considerable revision to induce the ongoing quality improvement process that is required to optimize overall guideline adherence. To assess its value, the programme needs to be tested in a randomized controlled trial. PMID:23705912

  17. Revision of the OECD Genetox Test Guidelines

    EPA Science Inventory

    The OECD Test Guidelines (TG) on genetic toxicology were initially prepared and adopted between 1981 and 1986. In 1997 the most commonly used guidelines were updated, and the in vivo UDS test (TG 486) was added. More recently, in 2010 and 2011, two new guidelines were adopted: th...

  18. Korean Guidelines for Colorectal Cancer Screening and Polyp Detection

    PubMed Central

    Lee, Bo-In; Hong, Sung Pil; Kim, Seong-Eun; Kim, Se Hyung; Hong, Sung Noh; Yang, Dong-Hoon; Shin, Sung Jae; Lee, Suck-Ho; Park, Dong Il; Kim, Young-Ho; Kim, Hyun Jung; Yang, Suk-Kyun; Kim, Hyo Jong; Jeon, Hae Jeong

    2012-01-01

    Now colorectal cancer is the second most common cancer in males and the fourth most common cancer in females in Korea. Since most of colorectal cancers occur after the prolonged transformation of adenomas into carcinomas, early detection and removal of colorectal adenomas are one of the most effective methods to prevent colorectal cancer. Considering the increasing incidence of colorectal cancer and polyps in Korea, it is very important to establish Korean guideline for colorectal cancer screening and polyp detection. The guideline was developed by the Korean Multi-Society Take Force and we tried to establish the guideline by evidence-based methods. Parts of the statements were draw by systematic reviews and meta-analyses. Herein we discussed epidemiology of colorectal cancers and adenomas in Korea and optimal methods for screening of colorectal cancer and detection of adenomas including fecal occult blood tests, radiologic tests, and endoscopic examinations. PMID:22741131

  19. Japanese Society of Medical Oncology Clinical Guidelines: Molecular Testing for Colorectal Cancer Treatment, Third Edition.

    PubMed

    Yamazaki, Kentaro; Taniguchi, Hiroya; Yoshino, Takayuki; Akagi, Kiwamu; Ishida, Hideyuki; Ebi, Hiromichi; Nakatani, Kaname; Muro, Kei; Yatabe, Yasushi; Yamaguchi, Kensei; Tsuchihara, Katsuya

    2018-06-01

    The Japanese Society of Medical Oncology (JSMO) previously published 2 editions of the clinical guidelines: "Japanese guidelines for testing of KRAS gene mutation in colorectal cancer" in 2008 and "Japanese Society of Medical Oncology Clinical Guidelines: RAS (KRAS/NRAS) mutation testing in colorectal cancer patients" in 2014. These guidelines have contributed to the proper use of KRAS and RAS mutation testing, respectively. Recently, clinical utility, particularly for colorectal cancer (CRC) patients with BRAF V600E mutation or DNA mismatch-repair (MMR) deficiency, has been established. Therefore, the guideline members decided these genetic alterations should also be involved. The aim of this revision is to properly carry out testing for BRAF V600E mutation and MMR deficiency in addition to RAS mutation. The revised guidelines include the basic requirements for testing for these genetic alterations based on recent scientific evidence. Furthermore, because clinical utility of comprehensive genetic testing using next-generation sequencing and somatic gene testing of analyzing circulating tumor DNA has increasingly evolved with recent advancements in testing technology, we noted the current situation and prospects for these testing technologies and their clinical implementation in the revised guidelines. © 2018 The Authors. Cancer Science published by John Wiley & Sons Australia, Ltd on behalf of Japanese Cancer Association.

  20. Draft Test Guideline: Whole Sediment Acute Toxicity Invertebrates, Freshwater

    EPA Pesticide Factsheets

    The following draft test guideline is part of a series of test guidelines that have been developed by EPA for use in the testing of pesticides and toxic substances, and the development of test data for submission to the Agency for review.

  1. Draft Test Guideline: Whole Sediment Acute Toxicity Invertebrates, Marine

    EPA Pesticide Factsheets

    The following draft test guideline is part of a series of test guidelines that have been developed by EPA for use in the testing of pesticides and toxic substances, and the development of test data for submission to the Agency for review.

  2. Critical attitudes and beliefs towards guidelines amongst palliative care professionals - results from a national survey.

    PubMed

    Kalies, Helen; Schöttmer, Rieke; Simon, Steffen T; Voltz, Raymond; Crispin, Alexander; Bausewein, Claudia

    2017-03-21

    Little is known about palliative care professionals' attitudes towards guidelines. In 2015, the German Association for Palliative Medicine (DGP) published an evidence based guideline for palliative care in adults with incurable cancer. Before publication we conducted a national survey among members of the DGP to detect possible barriers and facilitators for its implementation. The aim of the present publication was to evaluate critical attitudes and beliefs which could hinder the effective implementation of the new guideline and to evaluate differences within professional groups and medical specialisations. This web-based online survey was addressed to all members of the DGP in summer 2014. Twenty-one questions concerning attitudes and beliefs towards guidelines were a priori developed to represent the following topics: scepticism regarding the quality of guidelines, doubts about the implementation of guidelines, restrictions in treatment options through guidelines, discrepancy between palliative care values and guidelines. Differences within professions and specialisations were tested using Kruskal-Wallis tests. All 4.786 members with known email address were invited, 1.181 followed the link, 1.138 began to answer the questionnaire and 1.031 completed the questionnaire. More than half of participating members were physicians and one third nurses. Scepticism regarding the quality of existing guidelines was high (range 12.8-73.2%). Doubts regarding practical aspects of guidelines were less prevalent but still high (range 21.8-57.6%). About one third (range 5.4-31.4%) think that guidelines restrict their treatment options. In addition, 38.8% believed that guidelines are a kind of cookbook and restrict the flexibility of individual patient care. The majority saw no or little discrepancy between palliative care values and guidelines (range 68.4-82.6%). There were relatively small but significant differences between professions and specialisations. The person-centred and individual approach of palliative care does not seem to contradict the acceptance of guidelines. Main barriers were related to scepticism regarding the quality of guidelines and the implementation of guidelines in general.

  3. Development of a novel, multilayered presentation format for clinical practice guidelines.

    PubMed

    Kristiansen, Annette; Brandt, Linn; Alonso-Coello, Pablo; Agoritsas, Thomas; Akl, Elie A; Conboy, Tara; Elbarbary, Mahmoud; Ferwana, Mazen; Medani, Wedad; Murad, Mohammad Hassan; Rigau, David; Rosenbaum, Sarah; Spencer, Frederick A; Treweek, Shaun; Guyatt, Gordon; Vandvik, Per Olav

    2015-03-01

    Bridging the gap between clinical research and everyday health-care practice requires effective communication strategies. To address current shortcomings in conveying practice recommendations and supporting evidence, we are creating and testing presentation formats for clinical practice guidelines (CPGs). We carried out multiple cycles of brainstorming and sketching, developing a prototype. Physicians participating in the user testing viewed CPG formats linked to clinical scenarios and engaged in semistructured interviews applying a think-aloud method for exploring important aspects of user experience. We developed a multilayered presentation format that allows clinicians to successively view more in-depth information. Starting with the recommendations, clinicians can, on demand, access a rationale and a key information section containing statements on quality of the evidence, balance between desirable and undesirable consequences, values and preferences, and resource considerations. We collected feedback from 27 stakeholders and performed user testing with 47 practicing physicians from six countries. Advisory group feedback and user testing of the first version revealed problems with conceptual understanding of underlying CPG methodology, as well as difficulties with the complexity of the layout and content. Extensive revisions made before the second round of user testing resulted in most participants expressing overall satisfaction with the final presentation format. We have developed an electronic, multilayered, CPG format that enhances the usability of CPGs for frontline clinicians. We have implemented the format in electronic guideline tools that guideline organizations can now use when authoring and publishing their guidelines.

  4. Guidelines for testing and release procedures

    NASA Technical Reports Server (NTRS)

    Molari, R.; Conway, M.

    1984-01-01

    Guidelines and procedures are recommended for the testing and release of the types of computer software efforts commonly performed at NASA/Ames Research Center. All recommendations are based on the premise that testing and release activities must be specifically selected for the environment, size, and purpose of each individual software project. Guidelines are presented for building a Test Plan and using formal Test Plan and Test Care Inspections on it. Frequent references are made to NASA/Ames Guidelines for Software Inspections. Guidelines are presented for selecting an Overall Test Approach and for each of the four main phases of testing: (1) Unit Testing of Components, (2) Integration Testing of Components, (3) System Integration Testing, and (4) Acceptance Testing. Tools used for testing are listed, including those available from operating systems used at Ames, specialized tools which can be developed, unit test drivers, stub module generators, and the use of format test reporting schemes.

  5. 77 FR 22282 - Draft Guidelines on Biologics Quality Monitoring: Testing for the Detection of Mycoplasma...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-13

    ...] Draft Guidelines on Biologics Quality Monitoring: Testing for the Detection of Mycoplasma Contamination... Detection of Mycoplasma Contamination.'' This draft guideline identifies stages of manufacture where... contamination. Because the guidelines apply to final product and master seed/cell testing in veterinary vaccines...

  6. Experimental investigations and guidelines for PCB design for a fuel injection ECU to meet automotive environmental, EMI/EMC and ESD standards

    NASA Astrophysics Data System (ADS)

    Kalyankar-Narwade, Supriya; Kumar, C. Ramesh; Patil, Sanjay A.

    2017-11-01

    Engine Management ECU plays a vital role in controlling different important features related to the engine performance. ECU is an embedded system which includes hardware and firmware platform for control logics. However, it is necessary to verify its smooth performance by its functionality testing in the Electromagnetic environment for approval. If these requirements are not known at earlier stages, then ECU may not fulfil functional requirements during required automotive electronic test standards. Hence, focusing on EMS ECU, this paper highlights hardware, layout and software guidelines for solving problems related with Electromagnetic Interference (EMI) to comply ISO 7637, CISPR 25 standard, Electromagnetic Compatibility (EMC) to comply ISO 11452-4,5 standard, Electrostatic Discharge (ESD) to comply ISO 10605 standard and Environmental Testing to comply standards as per IEC standards. This paper specifies initially the importance, need and guidelines for reducing the EMI effect on PCB i.e. making ECU more electromagnetically compatible as per automotive standards. The guidelines are useful for the designers to avoid pitfalls at the later stage. After mentioned modifications in the paper, ECU successfully passed the requirements for all standard tests.

  7. Draft Test Guideline: Fish Acute Toxicity Mitigated By Humic Acid

    EPA Pesticide Factsheets

    The following draft test guideline is part of a series of test guidelines that have been developed by EPA for use in the testing of pesticides and toxic substances, and the development of test data for submission to the Agency for review.

  8. Draft Test Guideline: Special Considerations for Conducting Aquatic Laboratory Studies

    EPA Pesticide Factsheets

    The following draft test guideline is part of a series of test guidelines that have been developed by EPA for use in the testing of pesticides and toxic substances, and the development of test data for submission to the Agency for review.

  9. Dissemination Strategies to Improve Implementation of the PHS Smoking Cessation Guideline in MCH Public Health Clinics: Experimental Evaluation Results and Contextual Factors

    ERIC Educational Resources Information Center

    Manfredi, Clara; Cho, Young Ik; Warnecke, Richard; Saunders, Stephen; Sullivan, Myrtis

    2011-01-01

    We report results from an experimental study that tested the effectiveness of dissemination interventions to improve implementation of smoking cessation guidelines in maternal and child public health clinics. We additionally examine individual clinic results for contextual explanations not apparent from the experimental findings alone. Twelve…

  10. Review of achievements of the OECD Working Party on Manufactured Nanomaterials' Testing and Assessment Programme. From exploratory testing to test guidelines.

    PubMed

    Rasmussen, Kirsten; González, Mar; Kearns, Peter; Sintes, Juan Riego; Rossi, François; Sayre, Phil

    2016-02-01

    This paper charts the almost ten years of history of OECD's work on nanosafety, during which the programme of the OECD on the Testing and Assessment of Manufactured Nanomaterials covered the testing of eleven nanomaterials for about 59 end-points addressing physical-chemical properties, mammalian and environmental toxicity, environmental fate and material safety. An overview of the materials tested, the test methods applied and the discussions regarding the applicability of the OECD test guidelines, which are recognised methods for regulatory testing of chemicals, are given. The results indicate that many existing OECD test guidelines are suitable for nanomaterials and consequently, hazard data collected using such guidelines will fall under OECD's system of Mutual Acceptance of Data (MAD) which is a legally binding instrument to facilitate the international acceptance of information for the regulatory safety assessment of chemicals. At the same time, some OECD test guidelines and guidance documents need to be adapted to address nanomaterials while new test guidelines and guidance documents may be needed to address endpoints that are more relevant to nanomaterials. This paper presents examples of areas where test guidelines or guidance for nanomaterials are under development. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

  11. NASA Contractor Report: Guidelines for Proof Test Analysis

    NASA Technical Reports Server (NTRS)

    Chell, G. G.; McClung, R. C.; Kuhlman, C. J.; Russell, D. A.; Garr, K.; Donnelly, B.

    1997-01-01

    These Guidelines integrate state-of-the-art Elastic-Plastic Fracture Mechanics (EPFM) and proof test implementation issues into a comprehensive proof test analysis procedure in the form of a Road Map which identifies the types of data, fracture mechanics based parameters, and calculations needed to perform flaw screening and minimum proof load analyses of fracture critical components. Worked examples are presented to illustrate the application of the Road Map to proof test analysis. The state-of-the-art fracture technology employed in these Guidelines is based on the EPFM parameter, J, and a pictorial representation of a J fracture analysis, called the Failure Assessment Diagram (FAD) approach. The recommended fracture technology is validated using finite element J results, and laboratory and hardware fracture test results on the nickel-based superalloy IN-718, the aluminum alloy 2024-T351 1, and ferritic pressure vessel steels. In all cases the laboratory specimens and hardware failed by ductile mechanisms. Advanced proof test analyses involving probability analysis and Multiple Cycle Proof Testing (MCPT) are addressed. Finally, recommendations are provided on to how to account for the effects of the proof test overload on subsequent service fatigue and fracture behaviors.

  12. Genetic testing for BRCA1: effects of a randomised study of knowledge provision on interest in testing and long term test uptake; implications for the NICE guidelines.

    PubMed

    Hall, Julia; Gray, Susan; A'Hern, Roger; Shanley, Susan; Watson, Maggie; Kash, Kathryn; Croyle, Robert; Eeles, Rosalind

    2009-01-01

    Interest in searching for mutations in BRCA1 and BRCA2 is high. Knowledge regarding these genes and the advantages and limitations of genetic testing is limited. It is unknown whether increasing knowledge about breast cancer genetic testing alters interest in testing. Three hundred and seventy nine women (260 with a family history of breast cancer; 119 with breast cancer) from The Royal Marsden NHS Foundation Trust were randomised to receive or not receive written educational information on cancer genetics. A questionnaire was completed assessing interest in BRCA1 testing and knowledge on breast cancer genetics and screening. Actual uptake of BRCA1 testing is reported with a six year follow-up. Eighty nine percent of women at risk of breast cancer and 76% of women with breast cancer were interested in BRCA1 testing (P < 0.0001). Provision of educational information did not affect level of interest. Knowledge about breast cancer susceptibility genes was poor. According to the NICE guidelines regarding eligibility for BRCA1 and BRCA2 testing, the families of 66% of the at risk group and 13% of the women with breast cancer would be eligible for testing (probability of BRCA1 mutation >or=20%). Within six years of randomisation, genetic testing was actually undertaken on 12 women, only 10 of whom would now be eligible, on the NICE guidelines. There is strong interest in BRCA1 testing. Despite considerable ignorance of factors affecting the inheritance of breast cancer, education neither reduced nor increased interest to undergo testing. The NICE guidelines successfully triage those with a high breast cancer risk to be managed in cancer genetics clinics.

  13. A tailored e-learning program to improve handover in the chain of emergency care: a pre-test post-test study.

    PubMed

    Ebben, Remco H A; van Grunsven, Pierre M; Moors, Marie Louise; Aldenhoven, Peter; de Vaan, Jordan; van Hout, Roger; van Achterberg, Theo; Vloet, Lilian C M

    2015-04-16

    To standardize patient handover in the chain of emergency care a handover guideline was developed. The main guideline recommendation is to use the DeMIST model (Demographics, Mechanism of Injury/illness, Injury/Illness, Signs, Treatment given) to structure pre-hospital notification and handover. To benefit from the new guideline, guideline adherence is necessary. As adherence to guidelines in emergency care settings is variable, there is a need to systematically implement the new guideline. For implementation of the guideline we developed a e-learning program tailored to influencing factors. The aim of the study was to evaluate the effectiveness of this e-learning program to improve emergency care professionals' adherence to the handover guideline during pre-hospital notification and handover in the chain of emergency medical service (EMS), emergency medical dispatch (EMD), and emergency department (ED). A prospective pre-test post-test study was conducted. The intervention was a tailored e-learning program that was offered to ambulance crew and emergency medical dispatchers (n=88). Data on adherence included pre-hospital notifications and handovers and were collected through observations and audiotapes before and after the e-learning program. Data were analyzed using X(2)-tests and t-tests. In total, 78/88 (88.6%) professionals followed the e-learning program. During pre- and post-test, 146 and 169 handovers were observed respectively. After the e-learning program, no significant difference in the number of handovers with the DeMIST model (77.9% vs. 73.1%, p=.319) and the number of handovers with the correct sequence of the DeMIST model (69.9% vs. 70.5%, p=.159) existed. During the handover, the number of questions by ED staff and interruptions significantly increased from 49.0% to 68.9% and from 15.2% to 52.7% respectively (both p=.000). Most handovers were performed after patient transfer, this did not change after the intervention (p=.167). The number of handovers where information was documented during handover slightly increased from 26.9% to 29.3% (p=.632). The tailored e-learning program did not improve adherence to a handover guideline in the chain of emergency care. Results show a relatively high baseline adherence rate to usage and correct sequence of the DeMIST model. Improvements in the handover process can be made on the documentation of information during handover, the number of interruptions and questions, and the handover moment.

  14. Current use of pharmacogenetic testing: a national survey of thiopurine methyltransferase testing prior to azathioprine prescription.

    PubMed

    Fargher, E A; Tricker, K; Newman, W; Elliott, R; Roberts, S A; Shaffer, J L; Bruce, I; Payne, K

    2007-04-01

    Azathioprine is an immunosuppressant prescribed for the treatment of inflammatory conditions and after organ transplantation. Risk of neutropaenia has limited the effective use of azathioprine (AZA) and driven requirements for careful monitoring and blood tests. Thiopurine methyltransferase (TPMT) is a genetically moderated key enzyme involved in the metabolism of AZA that can be used to stratify individuals into different levels of risk of developing neutropaenia. Two techniques can be used to measure TPMT status: enzyme-level testing (phenotype testing) and DNA based testing (genotype testing). To identify the current uptake of TPMT enzyme-level testing, TPMT genotype testing, and, the role of guidelines; to inform the prescribing and monitoring of AZA. A survey was mailed to a consultant dermatologist, gastroenterologist, and rheumatologist at every NHS Hospital Trust in England. The survey comprised mainly closed questions exploring: use of AZA and monitoring; use of TPMT enzyme-level testing and genotype testing; and, the role of guidelines to guide prescribing practice. A 70% (n=287) response rate was obtained. The majority of respondents reported prescribing AZA (99%, n=283). Prescribing and monitoring patterns differed between individual respondents and between the three disciplines. TPMT enzyme-level testing was reportedly used by 67% (n=189) of respondents, but this differed by discipline (dermatologists 94%, gastroenterologists 60%, rheumatologists 47%). In 91% of cases enzyme-level testing was carried out prior to prescribing AZA. Genotype testing is not typically available to NHS clinicians but 15 clinicians (six dermatologists, six gastroenterologists, three rheumatologists) reported using it. Most consultants (82%) reported using guidelines to inform their AZA prescribing and monitoring (dermatologists 81%, gastroenterologists 75%, rheumatologists 94%). Two-thirds of the consultants surveyed in England are using TPMT enzyme-level testing, prior to AZA treatment. Uptake differs between specialities. High uptake of TPMT enzyme-level testing by dermatologists, compared with gastroenterologists and rheumatologists, may reflect national guidelines advocating its use prior to AZA. Uptake of enzyme-level testing may alter in other specialties as other guidelines are developed.

  15. Insurance Coverage Policies for Pharmacogenomic and Multi-Gene Testing for Cancer.

    PubMed

    Lu, Christine Y; Loomer, Stephanie; Ceccarelli, Rachel; Mazor, Kathleen M; Sabin, James; Clayton, Ellen Wright; Ginsburg, Geoffrey S; Wu, Ann Chen

    2018-05-16

    Insurance coverage policies are a major determinant of patient access to genomic tests. The objective of this study was to examine differences in coverage policies for guideline-recommended pharmacogenomic tests that inform cancer treatment. We analyzed coverage policies from eight Medicare contractors and 10 private payers for 23 biomarkers (e.g., HER2 and EGFR ) and multi-gene tests. We extracted policy coverage and criteria, prior authorization requirements, and an evidence basis for coverage. We reviewed professional society guidelines and their recommendations for use of pharmacogenomic tests. Coverage for KRAS , EGFR , and BRAF tests were common across Medicare contractors and private payers, but few policies covered PML/RARA , CD25 , or G6PD . Thirteen payers cover multi-gene tests for nonsmall lung cancer, citing emerging clinical recommendations. Coverage policies for single and multi-gene tests for cancer treatments are consistent among Medicare contractors despite the lack of national coverage determinations. In contrast, coverage for these tests varied across private payers. Patient access to tests is governed by prior authorization among eight private payers. Substantial variations in how payers address guideline-recommended pharmacogenomic tests and the common use of prior authorization underscore the need for additional studies of the effects of coverage variation on cancer care and patient outcomes.

  16. Enhancing health care professionals' and trainees' knowledge of physical activity guidelines for adults with and without SCI.

    PubMed

    Shirazipour, Celina H; Tomasone, Jennifer R; Martin Ginis, Kathleen A

    2018-01-11

    Health care providers (HCPs) are preferred sources of physical activity (PA) information; however, minimal research has explored HCPs' knowledge of spinal cord injury (SCI) PA guidelines, and no research has examined HCP trainees' PA guideline knowledge. The current study explored HCPs' and trainees' initial knowledge of PA guidelines for both adults with SCI and the general population, and the utility of an event-based intervention for improving this knowledge. Participants (HCPs n = 129; trainees n = 573) reported guideline knowledge for both sets of guidelines (SCI and general population) immediately after, one-month, and six-months following the intervention. Frequencies determined guideline knowledge at each timepoint, while chi-squared tests examined differences in knowledge of both guidelines, as well as knowledge differences in the short- and long-term. Results demonstrated that HCPs and trainees lack knowledge of PA guidelines, particularly guidelines for adults with SCI. The results further suggest that a single event-based intervention is not effective for improving long-term guideline knowledge. Suggestions are made for future research with the aim of improving interventions that target HCP and HCP trainees' long-term guideline knowledge for adults with SCI and the general population.

  17. Evaluation of five guidelines for option development in multiple-choice item-writing.

    PubMed

    Martínez, Rafael J; Moreno, Rafael; Martín, Irene; Trigo, M Eva

    2009-05-01

    This paper evaluates certain guidelines for writing multiple-choice test items. The analysis of the responses of 5013 subjects to 630 items from 21 university classroom achievement tests suggests that an option should not differ in terms of heterogeneous content because such error has a slight but harmful effect on item discrimination. This also occurs with the "None of the above" option when it is the correct one. In contrast, results do not show the supposedly negative effects of a different-length option, the use of specific determiners, or the use of the "All of the above" option, which not only decreases difficulty but also improves discrimination when it is the correct option.

  18. Adherence to multiple cancer screening tests among women living in Appalachia Ohio

    PubMed Central

    Katz, Mira L.; Reiter, Paul L.; Young, Gregory S.; Pennell, Michael L.; Tatum, Cathy M.; Paskett, Electra D.

    2015-01-01

    Background There is a lack of information about the correlates of completing all three cancer screening tests among women living in Appalachia. Methods Cross-sectional telephone interviews were conducted (April-September 2013) among women (n=637) ages 51-75 from 12 Appalachia Ohio counties. Outcomes of within screening guidelines were verified by medical record. Multivariable logistic regression models identified correlates of being within guidelines for all three cancer screening tests. Results Screening rates were: mammography (32.1%), Pap test (36.1%), and a colorectal cancer test (30.1%). Only 8.6% of women were within guidelines for all tests. Having had a check-up in the past two years and having received a screening recommendation were significantly related to being within guidelines for all three tests (p<0.01). Participants with higher annual household incomes ($60,000+; OR=3.53, 95% CI: 1.49, 8.33) and conditions requiring regular medical visits (OR=3.16, 95% CI: 1.29, 7.74) were more likely to be within guidelines for all three screening tests. Conclusion Less than 10% of women had completed screening within guidelines for all three screening tests. Regular contact with the healthcare system and higher incomes were significant predictors of being within guidelines. Impact Within guidelines rates for the three recommended cancer screening tests is low among women in Appalachia Ohio. This finding illustrates the need for innovative interventions to improve rates of multiple cancer screening tests. PMID:26282630

  19. An implementation strategy to improve the guideline adherence of insurance physicians: an experiment in a controlled setting

    PubMed Central

    2011-01-01

    Background The aim of this study was to investigate the efficacy of a newly developed implementation strategy for the insurance medicine guidelines for depression in the Netherlands. We hypothesized that an educational intervention would increase the insurance physicians' (IPs) guideline adherence in a controlled setting. Methods Forty IPs were allocated in a randomised controlled trial (RCT) to an intervention group (IG) (n = 21) and a control group (CG) (n = 19). The IG received tailored training in applying the guidelines for depression, while the CG received an alternative programme. Baseline (T0) and follow-up (T1) measurements were conducted before and after the intervention within a period of two weeks. The intervention consisted of a workshop in which the evidence-based theory of the guidelines was translated for use in practice, with the help of various tools. The IPs had to write a case-report on the basis of video cases, two before and two after the training. Specially trained and blinded test IPs judged the case reports independently on the basis of six performance indicators. Primary outcome measure in the controlled setting of the trial was guideline adherence measured by six performance indicators on a scale of one to seven. Secondary outcome measure was knowledge of the guidelines for depression. Analyses were performed using Linear Mixed Models, and ANCOVA. Results We found significantly higher scores in the IG than in the CG at T1 for both outcomes. The interaction effect (standard error; p-value) of group crossed with time was 0.97 (0.19; p < 0.0005) for guideline adherence in the controlled setting. The group effect at T1 for the knowledge test was 0.86 (0.40; p = 0.038). Conclusions The newly developed implementation strategy for the insurance medicine guidelines for depression improved the guideline adherence of the trained IPs in disability assessments of clients with depression when performed in a controlled setting. Furthermore, the trained IPs showed gains in knowledge of the guidelines for depression. Trial registration Netherlands' Trial Register NTR1863. PMID:22188876

  20. Steps Ahead: Adaptation of physical activity and dietary guidelines for reducing unhealthy weight gain in the Lower Misissippi Delta

    USDA-ARS?s Scientific Manuscript database

    The purpose of our study was to test the effectiveness of adapting the Dietary Guidelines for Americans (2010) (DG), with and without a physical activity (PA) component, in reducing weight gain in the Lower Mississippi Delta region (LMD) of the United States. A sample of 121 White and African-Americ...

  1. Comprehensive Testing of ASL-Owned Accelerometers

    NASA Astrophysics Data System (ADS)

    Evans, J. R.; Hutt, C. R.; Ringler, A. T.; de la Torre, T.

    2011-12-01

    The Albuquerque Seismological Laboratory (ASL) of the U.S. Geological Survey (USGS) has undertaken detailed testing of several commercial, off-the-shelf accelerometers to characterize production-standard examples of each instrument. The models tested are the Geotech PA-23, Guralp CMG-5TC, Kinemetrics ES-T (Episensor), Nanometrics Titan (sensor only), and RefTek RT-147-01/3. All are ±4 g accelerometers excepting the CMG-5TC at ±2 g (self noise could be depressed relative to 4-g variant). For dynamic tests, all were recorded on Quanterra Q330 (24-bit) or Q330HR (26-bit) recorders; for static tests high-precision multimeters were used (generally Agilent 3458A 81/2-digit or 34401A 61/2-digit). We also used a translational shake table (Anorad LW10-18-P-E-A-A-B-0) to input controlled test motions. We performed the tests described by Hutt et al. (2010; U.S. Geol. Surv. Open File Rep., 2009-1295, http://pubs.usgs.gov/of/2009/1295/) for these strong-motion sensors (Section 7, Recommended Testing for Strong Motion Acceleration Sensors). These recommended tests result from a public/private effort called "GST2" (the second Guidelines for Seismometer Testing workshop) and represent a consensus of experts in government, academia, and industry (a secondary goal of this work is vetting the tests in this consensus document). The recommended accelerometer tests are: 7.1 Power Demand (Start-up and Steady-State) 7.2 Static Sensitivity, Offset, and Linearity 7.3 Frequency Response and Bandwidth 7.4 Clip Level 7.5 Self Noise and Operating Range 7.6 Distortion 7.7 Orientation (Case to Actual) and Orthogonally 7.8 Translational Cross-Axis Sensitivity 7.9 Temperature Effects (Sensitivity and Offset) 7.10 Power Supply Voltage and Voltage-Noise Effects (Offset and Sensitivity) 7.11 Double Integration (Band-Limited Displacement Square Wave) To the degree the tests and analyses have progressed at this writing, the results are generally good but have revealed a number of issues needing attention. A complete set of test results will be provided at the conference. For example, median self noise of all units is within ANSS guidelines but some are as quiet as ~12 dB below the guidelines, while sensitivities of all but one (malfunctioning) channel are within the 1% guideline, and the orientations of axes relative to instrument cases are nearly all within the 1° guideline. (Any use of trade, firm, or product names is for descriptive purposes only and does not imply endorsement by the U.S. Government.)

  2. 40 CFR 798.5200 - Mouse visible specific locus test.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... control groups. (4) Control groups—(i) Concurrent controls. The use of positive or spontaneous controls is... control groups. (ii) Test chemical vehicle, doses used and rationale for dose selection, toxicity data... SUBSTANCES CONTROL ACT (CONTINUED) HEALTH EFFECTS TESTING GUIDELINES Genetic Toxicity § 798.5200 Mouse...

  3. 40 CFR 798.5200 - Mouse visible specific locus test.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... control groups. (4) Control groups—(i) Concurrent controls. The use of positive or spontaneous controls is... control groups. (ii) Test chemical vehicle, doses used and rationale for dose selection, toxicity data... SUBSTANCES CONTROL ACT (CONTINUED) HEALTH EFFECTS TESTING GUIDELINES Genetic Toxicity § 798.5200 Mouse...

  4. 40 CFR 798.5200 - Mouse visible specific locus test.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... control groups. (4) Control groups—(i) Concurrent controls. The use of positive or spontaneous controls is... control groups. (ii) Test chemical vehicle, doses used and rationale for dose selection, toxicity data... SUBSTANCES CONTROL ACT (CONTINUED) HEALTH EFFECTS TESTING GUIDELINES Genetic Toxicity § 798.5200 Mouse...

  5. 40 CFR 798.5200 - Mouse visible specific locus test.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... control groups. (4) Control groups—(i) Concurrent controls. The use of positive or spontaneous controls is... control groups. (ii) Test chemical vehicle, doses used and rationale for dose selection, toxicity data... SUBSTANCES CONTROL ACT (CONTINUED) HEALTH EFFECTS TESTING GUIDELINES Genetic Toxicity § 798.5200 Mouse...

  6. 40 CFR 798.5200 - Mouse visible specific locus test.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... control groups. (4) Control groups—(i) Concurrent controls. The use of positive or spontaneous controls is... control groups. (ii) Test chemical vehicle, doses used and rationale for dose selection, toxicity data... SUBSTANCES CONTROL ACT (CONTINUED) HEALTH EFFECTS TESTING GUIDELINES Genetic Toxicity § 798.5200 Mouse...

  7. 76 FR 57031 - Draft Harmonized Test Guidelines; Notice of Availability and Request for Comments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-15

    ...EPA is announcing the availability of the draft test guidelines for Series 810--Product Performance Test Guidelines for Public Health Uses of Antimicrobial Agents, concerning specifically air, textiles, and water.

  8. An immunohistochemical and fluorescence in situ hybridization-based comparison between the Oracle HER2 Bond Immunohistochemical System, Dako HercepTest, and Vysis PathVysion HER2 FISH using both commercially validated and modified ASCO/CAP and United Kingdom HER2 IHC scoring guidelines.

    PubMed

    O'Grady, Anthony; Allen, David; Happerfield, Lisa; Johnson, Nicola; Provenzano, Elena; Pinder, Sarah E; Tee, Lilian; Gu, Mai; Kay, Elaine W

    2010-12-01

    Immunohistochemistry (IHC) is used as the frontline assay to determine HER2 status in invasive breast cancer patients. The aim of the study was to compare the performance of the Leica Oracle HER2 Bond IHC System (Oracle) with the current most readily accepted Dako HercepTest (HercepTest), using both commercially validated and modified ASCO/CAP and UK HER2 IHC scoring guidelines. A total of 445 breast cancer samples from 3 international clinical HER2 referral centers were stained with the 2 test systems and scored in a blinded fashion by experienced pathologists. The overall agreement between the 2 tests in a 3×3 (negative, equivocal and positive) analysis shows a concordance of 86.7% and 86.3%, respectively when analyzed using commercially validated and modified ASCO/CAP and UK HER2 IHC scoring guidelines. There is a good concordance between the Oracle and the HercepTest. The advantages of a complete fully automated test such as the Oracle include standardization of key analytical factors and improved turn around time. The implementation of the modified ASCO/CAP and UK HER2 IHC scoring guidelines has minimal effect on either assay interpretation, showing that Oracle can be used as a methodology for accurately determining HER2 IHC status in formalin fixed, paraffin-embedded breast cancer tissue.

  9. Introduction to Immunotoxicity

    EPA Science Inventory

    Recognition that the immune system is vulnerable to adverse effects after exposure to xenobiotics led to the discipline of immunotoxicology and the subsequent addition of immunotoxicology testing to regulatory guidelines for toxicity. Immunotoxic effects can result in immunosuppr...

  10. Shifting from presumptive to test-based management of malaria - technical basis and implications for malaria control in Ghana.

    PubMed

    Baiden, F; Malm, K; Bart-Plange, C; Hodgson, A; Chandramohan, D; Webster, J; Owusu-Agyei, S

    2014-06-01

    The presumptive approach was the World Health Organisation (WHO) recommended to the management of malaria for many years and this was incorporated into syndromic guidelines such as the Integrated Management of Childhood Illnesses (IMCI). In early 2010 however, WHO issued revised treatment guidelines that call for a shift from the presumptive to the test-based approach. Practically, this implies that in all suspected cases, the diagnosis of uncomplicated malaria should be confirmed using rapid test before treatment is initiated. This revision effectively brings to an end an era of clinical practice that span several years. Its implementation has important implications for the health systems in malaria-endemic countries. On the basis of research in Ghana and other countries, and evidence from program work, the Ghana National Malaria Control Program has issued revised national treatment guidelines that call for implementation of test-based management of malaria in all cases, and across all age groups. This article reviews the evidence and the technical basis for the shift to test-based management and examines the implications for malaria control in Ghana.

  11. The influence of standards and clinical guidelines on prosthetic and orthotic service quality: a scoping review.

    PubMed

    Sadeghi-Demneh, Ebrahim; Forghany, Saeed; Onmanee, Pornsuree; Trinler, Ursula; Dillon, Michael P; Baker, Richard

    2017-06-20

    Standards and guidelines are an integral part of prosthetic and orthotic service delivery in the developed world underpinned by an assumption that they lead to improved services. Implementing them has a cost, however, and that cost needs to be justified, particularly in resource-limited environments. This scoping review thus asks the question, "What is the evidence of the impact of standards and guidelines on service delivery outcomes in prosthetics and orthotics?" A structured search of three electronic databases (Medline, Scopus and Web of Science) followed by manual searching of title, abstract and full text, yielded 29 articles. Four categories of papers were identified: Descriptions and Commentaries (17 papers), Guideline Development (7), Guideline Testing (2) and Standards implementation (3). No articles were explicitly designed to assess the impact of standards and guidelines on service delivery outcomes in prosthetics and orthotics. Studies tended to be commentaries on or descriptions of guideline development, testing or implementation of standards. The literature is not sufficiently well developed to warrant the cost and effort of a systematic review. Future primary research should seek to demonstrate whether and how guidelines and standards improve the outcomes for people that require prostheses, orthoses and other assistive devices. Implications for Rehabilitation International Standards and Clinical Guidelines are now an integral part of clinical service provision in prosthetics and orthotics in the developed world. Complying with standards and guidelines has a cost and, particularly in resource-limited environments, it should be possible to justify this in terms of the resulting benefits. This scoping review concludes that there have been no previous studies designed to directly quantify the effects of implementing standards and guidelines on service delivery.

  12. Baseline ecological risk assessment of the Calcasieu Estuary, Louisiana: 2. An evaluation of the predictive ability of effects-based sediment quality guidelines

    USGS Publications Warehouse

    MacDonald, Donald D.; Ingersoll, Christopher G.; Smorong, Dawn E.; Sinclair, Jesse A.; Lindskoog, Rebekka; Wang, Ning; Severn, Corrine; Gouguet, Ron; Meyer, John; Field, Jay

    2011-01-01

    Three sets of effects-based sediment-quality guidelines (SQGs) were evaluated to support the selection of sediment-quality benchmarks for assessing risks to benthic invertebrates in the Calcasieu Estuary, Louisiana. These SQGs included probable effect concentrations (PECs), effects range median values (ERMs), and logistic regression model (LRMs)-based T50 values. The results of this investigation indicate that all three sets of SQGs tend to underestimate sediment toxicity in the Calcasieu Estuary (i.e., relative to the national data sets), as evaluated using the results of 10-day toxicity tests with the amphipod, Hyalella azteca, or Ampelisca abdita, and 28-day whole-sediment toxicity tests with the H. azteca. These results emphasize the importance of deriving site-specific toxicity thresholds for assessing risks to benthic invertebrates.

  13. A computerized handheld decision-support system to improve pulmonary embolism diagnosis: a randomized trial.

    PubMed

    Roy, Pierre-Marie; Durieux, Pierre; Gillaizeau, Florence; Legall, Catherine; Armand-Perroux, Aurore; Martino, Ludovic; Hachelaf, Mohamed; Dubart, Alain-Eric; Schmidt, Jeannot; Cristiano, Mirko; Chretien, Jean-Marie; Perrier, Arnaud; Meyer, Guy

    2009-11-17

    Testing for pulmonary embolism often differs from that recommended by evidence-based guidelines. To assess the effectiveness of a handheld clinical decision-support system to improve the diagnostic work-up of suspected pulmonary embolism among patients in the emergency department. Cluster randomized trial. Assignment was by random-number table, providers were not blinded, and outcome assessment was automated. (ClinicalTrials.gov registration number: NCT00188032). 20 emergency departments in France. 1103 and 1768 consecutive outpatients with suspected pulmonary embolism. After a preintervention period involving 20 centers and 1103 patients, in which providers grew accustomed to inputting clinical data into handheld devices and investigators assessed baseline testing, emergency departments were randomly assigned to activation of a decision-support system on the devices (10 centers, 753 patients) or posters and pocket cards that showed validated diagnostic strategies (10 centers, 1015 patients). Appropriateness of diagnostic work-up, defined as any sequence of tests that yielded a posttest probability less than 5% or greater than 85% (primary outcome) or as strict adherence to guideline recommendations (secondary outcome); number of tests per patient (secondary outcome). The proportion of patients who received appropriate diagnostic work-ups was greater during the trial than in the preintervention period in both groups, but the increase was greater in the computer-based guidelines group (adjusted mean difference in increase, 19.3 percentage points favoring computer-based guidelines [95% CI, 2.9 to 35.6 percentage points]; P = 0.023). Among patients with appropriate work-ups, those in the computer-based guidelines group received slightly fewer tests than did patients in the paper guidelines group (mean tests per patient, 1.76 [SD, 0.98] vs. 2.25 [SD, 1.04]; P < 0.001). The study was not designed to show a difference in the clinical outcomes of patients during follow-up. A handheld decision-support system improved diagnostic decision making for patients with suspected pulmonary embolism in the emergency department.

  14. Effect of enhanced information, values clarification, and removal of financial barriers on use of prenatal genetic testing: a randomized clinical trial.

    PubMed

    Kuppermann, Miriam; Pena, Sherri; Bishop, Judith T; Nakagawa, Sanae; Gregorich, Steven E; Sit, Anita; Vargas, Juan; Caughey, Aaron B; Sykes, Susan; Pierce, Lasha; Norton, Mary E

    2014-09-24

    Prenatal genetic testing guidelines recommend providing patients with detailed information to allow informed, preference-based screening and diagnostic testing decisions. The effect of implementing these guidelines is not well understood. To analyze the effect of a decision-support guide and elimination of financial barriers to testing on use of prenatal genetic testing and decision making among pregnant women of varying literacy and numeracy levels. Randomized trial conducted from 2010-2013 at prenatal clinics at 3 county hospitals, 1 community clinic, 1 academic center, and 3 medical centers of an integrated health care delivery system in the San Francisco Bay area. Participants were English- or Spanish-speaking women who had not yet undergone screening or diagnostic testing and remained pregnant at 11 weeks' gestation (n = 710). A computerized, interactive decision-support guide and access to prenatal testing with no out-of-pocket expense (n = 357) or usual care as per current guidelines (n = 353). The primary outcome was invasive diagnostic test use, obtained via medical record review. Secondary outcomes included testing strategy undergone, and knowledge about testing, risk comprehension, and decisional conflict and regret at 24 to 36 weeks' gestation. Women randomized to the intervention group, compared with those randomized to the control group, were less likely to have invasive diagnostic testing (5.9% vs 12.3%; odds ratio [OR], 0.45 [95% CI, 0.25-0.80]) and more likely to forgo testing altogether (25.6% vs 20.4%; OR, 3.30 [95% CI, 1.43-7.64], reference group screening followed by invasive testing). Women randomized to the intervention group also had higher knowledge scores (9.4 vs 8.6 on a 15-point scale; mean group difference, 0.82 [95% CI, 0.34-1.31]) and were more likely to correctly estimate the amniocentesis-related miscarriage risk (73.8% vs 59.0%; OR, 1.95 [95% CI, 1.39-2.75]) and their estimated age-adjusted chance of carrying a fetus with trisomy 21 (58.7% vs 46.1%; OR, 1.66 [95% CI, 1.22-2.28]). Significant differences did not emerge in decisional conflict or regret. Full implementation of prenatal testing guidelines using a computerized, interactive decision-support guide in the absence of financial barriers to testing resulted in less test use and more informed choices. If validated in additional populations, this approach may result in more informed and preference-based prenatal testing decision making and fewer women undergoing testing. clinicaltrials.gov Identifier: NCT00505596.

  15. Decision making about healthcare-related tests and diagnostic test strategies. Paper 4: International guidelines show variability in their approaches.

    PubMed

    Mustafa, Reem A; Wiercioch, Wojtek; Arevalo-Rodriguez, Ingrid; Cheung, Adrienne; Prediger, Barbara; Ivanova, Liudmila; Ventresca, Matthew; Brozek, Jan; Santesso, Nancy; Bossuyt, Patrick; Garg, Amit X; Lloyd, Nancy; Lelgemann, Monika; Bühler, Diedrich; Schünemann, Holger J

    2017-12-01

    The objective of the study was to describe and compare current practices in developing guidelines about the use of healthcare-related tests and diagnostic strategies (HCTDS). We sampled 37 public health and clinical practice guidelines about HCTDS from various sources without language restrictions. Detailed descriptions of the systems used to assess the quality of evidence and develop recommendations were challenging to find within guidelines. We observed much variability among and within organizations with respect to how they develop recommendations about HCTDS. Twenty-four percent of the guidelines did not consider health benefits and harms but based decisions solely on test accuracy. We did not identify guidelines that described the main potential care pathways involving tests for a healthcare problem. In addition, we did not identify guidelines that systematically assessed, described, and referenced the evidence that linked test accuracy and patient-important outcomes. There is considerable variability among the processes used and factors considered in developing recommendations about the use of tests. This variability may be the cause for the disagreement we observed in recommendations about testing for the same condition. Copyright © 2017 Elsevier Inc. All rights reserved.

  16. 75 FR 4380 - Draft Test Guidelines; Notice of Availability and Request for Comments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-27

    ... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPP-2009-0681; FRL-8437-2] Draft Test Guidelines; Notice...: Notice. SUMMARY: EPA is announcing the availability of four draft test guidelines for Product Performance... holidays. The Docket Facility telephone number is (703) 305-5805. Electronic access to the OPPTS Test...

  17. APA's Guidelines for Test User Qualifications: An Executive Summary.

    ERIC Educational Resources Information Center

    Turner, Samuel M.; DeMers, Stephen T.; Fox, Heather Roberts; Reed, Geoffrey M.

    2001-01-01

    Describes the American Psychological Association's (APA's) development of the Task Force on Test User Qualifications, explaining the APA's purpose in developing guidelines for the use of psychological tests. Highlights the historical background, the scope of the guidelines, generic knowledge and skills considered important for good test use, and…

  18. 75 FR 22809 - Mandatory Guidelines for Federal Workplace Drug Testing Programs

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-30

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Mandatory Guidelines for Federal Workplace Drug Testing... for Federal Workplace Drug Testing Programs (Mandatory Guidelines) from May 1, 2010, to October 1... drug testing programs as soon as possible that they will not be expected to implement the revisions to...

  19. NASA's Technical Handbook for Avoiding On-Orbit ESD Anomalies Due to Internal Charging Effects

    NASA Technical Reports Server (NTRS)

    Whittlesey, Albert; Garrett, Henry B.

    1996-01-01

    This paper describes NASA-HDBK-4002, "Avoiding Problems Caused by Spacecraft On-Orbit Internal Charging Effects". The handbook includes a description of internal charging and why it is of concern to spacecraft designers. It also suggests how to determine when a project needs to consider internal spacecraft charging, it contains an electron penetration depth chart, rationale for a critical electron flux criterion, a worst-case geosynchronous electron plasma spectrum, general design guidelines, quantitative design guidelines, and a typical materials characteristics list. Appendices include a listing of some environment codes, electron transport codes, a discussion of geostationary electron plasma environments, a brief description of electron beam and other materials tests, and transient susceptibility tests. The handbook will be in the web page, hftp://standards.nasa.gov. A prior document, NASA TP2361 "Design Guidelines for Assessing and controlling Spacecraft Charging Effects", 1984, is in use to describe mitigation techniques for the effects of surface charging of satellites in space plasma environments. HDBK-4002 is meant to complement 2361 and together, the pair of documents describe both cause and mitigation designs for problems caused by energetic space plasmas.

  20. 40 CFR 797.1300 - Daphnid acute toxicity test.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... continuous exposure over a specified period of time. In this guideline, the effect measured is immobilization... at a point in time, or passing through the test chamber during a specific interval. (7) Static system..., daphnids which have been cultured and acclimated in accordance with the test design are randomly placed...

  1. 40 CFR 797.1300 - Daphnid acute toxicity test.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... continuous exposure over a specified period of time. In this guideline, the effect measured is immobilization... at a point in time, or passing through the test chamber during a specific interval. (7) Static system..., daphnids which have been cultured and acclimated in accordance with the test design are randomly placed...

  2. 40 CFR 797.1300 - Daphnid acute toxicity test.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... continuous exposure over a specified period of time. In this guideline, the effect measured is immobilization... at a point in time, or passing through the test chamber during a specific interval. (7) Static system..., daphnids which have been cultured and acclimated in accordance with the test design are randomly placed...

  3. 40 CFR 797.1300 - Daphnid acute toxicity test.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... continuous exposure over a specified period of time. In this guideline, the effect measured is immobilization... at a point in time, or passing through the test chamber during a specific interval. (7) Static system..., daphnids which have been cultured and acclimated in accordance with the test design are randomly placed...

  4. 40 CFR 797.1300 - Daphnid acute toxicity test.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... continuous exposure over a specified period of time. In this guideline, the effect measured is immobilization... at a point in time, or passing through the test chamber during a specific interval. (7) Static system..., daphnids which have been cultured and acclimated in accordance with the test design are randomly placed...

  5. MYSID TWO-GENERATION TEST GUIDELINE

    EPA Science Inventory

    McKenney, Charles L., Jr. In press. Mysid Two-Generation Test Guideline. OECD Expert Group on Invertebrate Testing for Endocrine Disruptors, Organisation for Economic Co-operation and Development, Paris, France. 17 p. (ERL,GB 1215).

    This guideline describes a two-generati...

  6. Breast cancer genetics and managed care. The Kaiser Permanente experience.

    PubMed

    Kutner, S E

    1999-12-01

    In 1996, with evolution of the science of cancer genetics and the advent of commercially available BRCA1 and later BRCA2 testing, Kaiser Permanente began to apply these advances in clinical practice. Recommendations for referral to genetic counseling were developed in 1997 as the Clinical Practice Guidelines for Referral for Genetic Counseling for Inherited Susceptibility for Breast and Ovarian Cancer. Implementation of these guidelines with associated protocols in Kaiser Permanente's Northern California Region has occupied the ensuing years and includes dissemination of the high-risk guidelines for breast and ovarian cancer, dissemination of patient and physician educational materials on the breast cancer guidelines, monthly classes and taped healthphone messages for patients, interactive videoconferencing for physicians, a training seminar for medical geneticists who will counsel patients at risk, publication of articles on breast cancer and genetic risk in health plan member- and physician-directed magazines, identification and training of clinical specialists and supporting clinicians to care for patients before and after counseling, individual counseling and testing of patients and families, and development of a data registry. Implementing the guidelines helped us communicate the uncertainty surrounding breast cancer testing, and we were obliged to learn more about ethical, legal, societal, and insurance controversies surrounding genetic testing. Given the lack of effective prevention for breast or ovarian cancer and the difficulty of treatment, the appropriate use of genetics in patient care is essential. In the near future, we will see the need for cancer genetics to become an integral part of practice throughout the spectrum of health care. We at Kaiser Permanente feel that the breast cancer guideline project is the first step in this process.

  7. The influence of providing a clinical practice guideline on dental students' decision making.

    PubMed

    van der Sanden, Wil J M; Mettes, Dirk G; Plasschaert, Alphons J M; Mulder, Jan; Verdonschot, Emiel H

    2004-02-01

    The aim of this study was to assess the effect of the provision of a clinical practice guideline (CPG) on dental students' decisions to remove asymptomatic, impacted lower third molars. All dental students, who in 2001 were in the 3rd, 4th or 5th (final) year of their study at the Nijmegen College of Dental Sciences, were invited to participate. A pre-test-post-test control group design was used. Given 36 patient cases, all dental students were asked to assess the need for removal of asymptomatic, impacted lower third molars. All pre-test respondents were randomly allocated to the control or intervention group. After the provision of a CPG to the intervention group, both groups were asked to assess the same cases again. Frequencies of decisions to remove the third molars were calculated. Chi-square tests and anova were used to test the influence of study year and gender on the drop-out rate and on the effect of the provision of a CPG on students' treatment decisions. The decrease in indications to remove third molars by the intervention group was statistically significant (P < 0.05). In the control group, no significant decrease was observed. It was concluded that the provision of a CPG significantly influences dental students' decision making about treatment in a third-molar decision task. Students who used the CPG showed more guideline-conformed decision making.

  8. HIV testing for acute medical admissions: evaluation of a pilot study in Leicester, England.

    PubMed

    Palfreeman, Adrian; Nyatsanza, Farai; Farn, Helen; McKinnon, Graham; Schober, Paul; McNally, Paul

    2013-06-01

    The 2008 UK National Guidelines for HIV testing recommended HIV testing should be offered to all general medical admissions aged 16-60 years in high prevalence areas, and that this should be evaluated to ensure this was effective in diagnosing previously undiagnosed HIV. HIV testing was introduced as a routine test for all patients admitted to the acute medical admissions unit, comparisons were made between the testing rates before, during and after this intervention. The pilot was initiated in August 2009. Prior to the pilot the unit was carrying out 15 tests per month. However, when the pilot was introduced 82 tests were being carried out per month with a total of 10 new diagnoses since the start of the pilot. The proportion of patients tested versus those eligible for testing remained low varying between 6% and 22% month by month. 10 patients we found to be HIV positive with a prevalence of approximately 1%, 10 fold higher than the cut off for cost effectiveness used in the guidelines. Overall the pilot showed that HIV testing could be delivered without the use of extra resources and is acceptable to patients.

  9. TESTING FOR DEVELOPMENTAL NEUROTOXICITY: CURRENT APPROACHES AND FUTURE NEEDS.

    EPA Science Inventory

    There are many adverse effects on the nervous system following exposure to environmental chemicals during development. In a number of cases (e.g., lead, methyl mercury) the developing nervous system is a highly susceptible. Developmental Neurotoxicity Testing (DNT) guidelines...

  10. Drug Development Pipeline

    MedlinePlus

    ... Care Guidelines Newborn Screening Clinical Care Guidelines Sweat Test Clinical Care Guidelines Infection Prevention and Control Care Guidelines Allergic Bronchopulmonary Aspergillosis Clinical Care Guidelines ...

  11. 77 FR 38282 - Final Test Guidelines; OCSPP 850 Series; Notice of Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-27

    ... conditions. EPA is changing the title of OPPTS 850.4450 ``Aquatic Plants Field Study, Tier III'' test....4300 ``Terrestrial Plants Field Study, Tier III'' test guideline. Public Draft OPPTS 850.4025 ``Target..., OCSPP 850.4300 ``Terrestrial Plants Field Study.'' The target area test guideline covers a special case...

  12. 75 FR 75485 - Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-03

    ... Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal... Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were... Laboratories and Instrumented Initial Testing Facilities (IITF) must meet in order to conduct drug and specimen...

  13. Drug Testing Guidelines and Practices for Juvenile Probation and Parole Agencies.

    ERIC Educational Resources Information Center

    American Probation and Parole Association, Lexington, KY.

    This document, intended as a resource manual, provides guidelines on drug testing. These topics are covered: (1) National Institute on Drug Abuse guidelines applicability; (2) introduction to legal issues, drug testing in juvenile probation and parole, and juvenile law; (3) mission of a juvenile parole agency; (4) purpose of testing; (5) drug…

  14. 75 FR 62842 - Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-13

    ... Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal... Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were... and Instrumented Initial Testing Facilities (IITF) must meet in order to conduct drug and specimen...

  15. What Affects Authors’ and Editors’ Use of Reporting Guidelines? Findings from an Online Survey and Qualitative Interviews

    PubMed Central

    Fuller, Thomas; Pearson, Mark; Peters, Jaime; Anderson, Rob

    2015-01-01

    Objectives To identify and understand, through data from multiple sources, some of the factors that affect authors’ and editors’ decisions to use reporting guidelines in the publication of health research. Design Mixed methods study comprising an online survey and semi-structured interviews with a sample of authors (online survey: n = 56; response rate = 32%; semi-structured interviews: n = 5) and journal editors (online survey: n = 43; response rate = 27%; semi-structured interviews: n = 6) involved in publishing health and medical research. Participants were recruited from an earlier study examining the effectiveness of the TREND reporting guideline. Results Four types of factors interacted to affect authors’ and editors’ likelihood of reporting guideline use; individual (e.g. having multiple reasons for use of reporting guidelines); the professional culture in which people work; environmental (e.g. policies of journals); and, practical (e.g. having time to use reporting guidelines). Having multiple reasons for using reporting guidelines was a particularly salient factor in facilitating reporting guidelines use for both groups of participants. Conclusions Improving the completeness and consistency of reporting of research studies is critical to the integrity and synthesis of health research. The use of reporting guidelines offers one potentially efficient and effective means for achieving this, but decisions to use (or not use) reporting guidelines take many factors into account. These findings could be used to inform future studies that might, for example, test the factors that we have identified within a wider theoretical framework for understanding changes in professional practices. The use of reporting guidelines by senior professionals appears to shape the expectations of what constitutes best practice and can be assimilated into the culture of a field or discipline. Without evidence of effectiveness of reporting guidelines, and sustained, multifaceted efforts to improve reporting, little progress seems likely to be made. PMID:25875918

  16. ITC Guidelines on Quality Control in Scoring, Test Analysis, and Reporting of Test Scores

    ERIC Educational Resources Information Center

    Allalouf, Avi

    2014-01-01

    The Quality Control (QC) Guidelines are intended to increase the efficiency, precision, and accuracy of the scoring, analysis, and reporting process of testing. The QC Guidelines focus on large-scale testing operations where multiple forms of tests are created for use on set dates. However, they may also be used for a wide variety of other testing…

  17. How to translate therapeutic recommendations in clinical practice guidelines into rules for critiquing physician prescriptions? Methods and application to five guidelines

    PubMed Central

    2010-01-01

    Background Clinical practice guidelines give recommendations about what to do in various medical situations, including therapeutical recommendations for drug prescription. An effective way to computerize these recommendations is to design critiquing decision support systems, i.e. systems that criticize the physician's prescription when it does not conform to the guidelines. These systems are commonly based on a list of "if conditions then criticism" rules. However, writing these rules from the guidelines is not a trivial task. The objective of this article is to propose methods that (1) simplify the implementation of guidelines' therapeutical recommendations in critiquing systems by automatically translating structured therapeutical recommendations into a list of "if conditions then criticize" rules, and (2) can generate an appropriate textual label to explain to the physician why his/her prescription is not recommended. Methods We worked on the therapeutic recommendations in five clinical practice guidelines concerning chronic diseases related to the management of cardiovascular risk. We evaluated the system using a test base of more than 2000 cases. Results Algorithms for automatically translating therapeutical recommendations into "if conditions then criticize" rules are presented. Eight generic recommendations are also proposed; they are guideline-independent, and can be used as default behaviour for handling various situations that are usually implicit in the guidelines, such as decreasing the dose of a poorly tolerated drug. Finally, we provide models and methods for generating a human-readable textual critique. The system was successfully evaluated on the test base. Conclusion We show that it is possible to criticize physicians' prescriptions starting from a structured clinical guideline, and to provide clear explanations. We are now planning a randomized clinical trial to evaluate the impact of the system on practices. PMID:20509903

  18. HIV pre-test information, discussion or counselling? A review of guidance relevant to the WHO European Region.

    PubMed

    Bell, Stephen A; Delpech, Valerie; Raben, Dorthe; Casabona, Jordi; Tsereteli, Nino; de Wit, John

    2016-02-01

    In the context of a shift from exceptionalism to normalisation, this study examines recommendations/evidence in current pan-European/global guidelines regarding pre-test HIV testing and counselling practices in health care settings. It also reviews new research not yet included in guidelines. There is consensus that verbal informed consent must be gained prior to testing, individually, in private, confidentially, in the presence of a health care provider. All guidelines recommend pre-test information/discussion delivered verbally or via other methods (information sheet). There is agreement about a minimum standard of information to be provided before a test, but guidelines differ regarding discussion about issues encouraging patients to think about implications of the result. There is heavy reliance on expert consultation in guideline development. Referenced scientific evidence is often more than ten years old and based on US/UK research. Eight new papers are reviewed. Current HIV testing and counselling guidelines have inconsistencies regarding the extent and type of information that is recommended during pre-test discussions. The lack of new research underscores a need for new evidence from a range of European settings to support the process of expert consultation in guideline development. © The Author(s) 2015.

  19. A population-based cross-sectional study of colorectal cancer screening practices of first-degree relatives of colorectal cancer patients

    PubMed Central

    2013-01-01

    Background The aim of this study was to determine the proportions and predictors of first-degree relatives (FDRs) of colorectal cancer (CRC) patients (i) ever receiving any CRC testing and (ii) receiving CRC screening in accordance with CRC screening guidelines. Methods Colorectal cancer patients and their FDRs were recruited through the population-based Victorian Cancer Registry, Victoria, Australia. Seven hundred and seven FDRs completed telephone interviews. Of these, 405 FDRs were deemed asymptomatic and eligible for analysis. Results Sixty-nine percent of FDRs had ever received any CRC testing. First-degree relatives of older age, those with private health insurance, siblings and FDRs who had ever been asked about family history of CRC by a doctor were significantly more likely than their counterparts to have ever received CRC testing. Twenty-five percent of FDRs “at or slightly above average risk” were adherent to CRC screening guidelines. For this group, adherence to guideline-recommended screening was significantly more likely to occur for male FDRs and those with a higher level of education. For persons at “moderately increased risk” and “potentially high risk”, 47% and 49% respectively adhered to CRC screening guidelines. For this group, guideline-recommended screening was significantly more likely to occur for FDRs who were living in metropolitan areas, siblings, those married or partnered and those ever asked about family history of CRC. Conclusions A significant level of non-compliance with screening guidelines was evident among FDRs. Improved CRC screening in accordance with guidelines and effective systematic interventions to increase screening rates among population groups experiencing inequality are needed. Trial Registration Australian and New Zealand Clinical Trial Registry: ACTRN12609000628246 PMID:23305355

  20. Developing Guidelines for HIV Antibody Testing among Victims of Pediatric Sexual Abuse.

    ERIC Educational Resources Information Center

    Gellert, George A.; And Others

    1990-01-01

    An interim set of human immunodeficiency virus (HIV) testing guidelines for victims of pediatric sexual abuse (PSA) is proposed. Guidelines are based on responses of 63 practitioners of PSA assessment to 7 hypothetical clinical profiles with 12 testing criteria. (Author/DB)

  1. Comments from the Developmental Neurotoxicology Committee of the Japanese Teratology Society on the OECD Guideline for the Testing of Chemicals, Proposal for a New Guideline 426, Developmental Neurotoxicity Study, Draft Document (October 2006 version), and on the Draft Document of the Retrospective Performance Assessment of the Draft Test Guideline 426 on Developmental Neurotoxicity.

    PubMed

    Ema, Makoto; Fukui, Yoshihiro; Aoyama, Hiroaki; Fujiwara, Michio; Fuji, Junichiro; Inouye, Minoru; Iwase, Takayuki; Kihara, Takahide; Oi, Akihide; Otani, Hiroki; Shinomiya, Mitsuhiro; Sugioka, Kozo; Yamano, Tsunekazu; Yamashita, Keisuke H; Tanimura, Takashi

    2007-06-01

    In October 2006, a new revision of the draft guideline (OECD Guideline for the Testing of Chemicals, Proposal for a New Guideline 426. Developmental Neurotoxicity Study) and Draft Document of the Retrospective Performance Assessment (RPA) of the Draft Test Guideline 426 on Developmental Neurotoxicity were distributed following incorporation of the results of the Expert Consultation Meeting in Tokyo on May 24-26, 2005. The draft guideline consists of 50 paragraphs and an appendix with 102 references; and the draft RPA consists of 37 paragraphs with 109 references. National coordinators were requested to arrange for national expert reviews of these draft documents in their member countries. Members of the Developmental Neurotoxicology (DNT) Committee of the Japanese Teratology Society (JTS) reviewed, discussed, and commented on the draft Test Guideline Proposal. The DNT Committee of the JTS also commented on the draft document of the RPA. These comments were sent to the OECD Secretariat. The DNT Committee of the JTS expects the comments to be useful for the finalization of these draft documents.

  2. Web-based computer-tailoring for practice nurses aimed to improve smoking cessation guideline adherence: A study protocol for a randomized controlled effectiveness trial.

    PubMed

    de Ruijter, D; Smit, E S; de Vries, H; Hoving, C

    2016-05-01

    Dutch practice nurses sub-optimally adhere to evidence-based smoking cessation guidelines. Web-based computer-tailoring could be effective in improving their guideline adherence. Therefore, this paper aims to describe the development of a web-based computer-tailored program and the design of a randomized controlled trial testing its (cost-)effectiveness. Theoretically grounded in the I-Change Model and Self-Determination Theory, and based on the results of a qualitative needs assessment among practice nurses, a web-based computer-tailored program was developed including three modules with tailored advice, an online forum, modules with up-to-date information about smoking cessation, Frequently Asked Questions (FAQs) and project information, and a counseling checklist. The program's effects are assessed by comparing an intervention group (access to all modules) with a control group (access to FAQs, project information and counseling checklist only). Smoking cessation guideline adherence and behavioral predictors (i.e. intention, knowledge, attitude, self-efficacy, social influence, action and coping planning) are measured at baseline and at 6- and 12-month follow-up. Additionally, the program's indirect effects on smokers' quit rates and the number of quit attempts are assessed after 6 and 12months. This paper describes the development of a web-based computer-tailored adherence support program for practice nurses and the study design of a randomized controlled trial testing its (cost-)effectiveness. This program potentially contributes to improving the quality of smoking cessation care in Dutch general practices. If proven effective, the program could be adapted for use by other healthcare professionals, increasing the public health benefits of improved smoking cessation counseling for smokers. Copyright © 2016 Elsevier Inc. All rights reserved.

  3. Item-Writing Guidelines for Physics

    ERIC Educational Resources Information Center

    Regan, Tom

    2015-01-01

    A teacher learning how to write test questions (test items) will almost certainly encounter item-writing guidelines--lists of item-writing do's and don'ts. Item-writing guidelines usually are presented as applicable across all assessment settings. Table I shows some guidelines that I believe to be generally applicable and two will be briefly…

  4. Derivation of a water quality guideline for aluminium in marine waters.

    PubMed

    Golding, Lisa A; Angel, Brad M; Batley, Graeme E; Apte, Simon C; Krassoi, Rick; Doyle, Chris J

    2015-01-01

    Metal risk assessment of industrialized harbors and coastal marine waters requires the application of robust water quality guidelines to determine the likelihood of biological impacts. Currently there is no such guideline available for aluminium in marine waters. A water quality guideline of 24 µg total Al/L has been developed for aluminium in marine waters based on chronic 10% inhibition or effect concentrations (IC10 or EC10) and no-observed-effect concentrations (NOECs) from 11 species (2 literature values and 9 species tested including temperate and tropical species) representing 6 taxonomic groups. The 3 most sensitive species tested were a diatom Ceratoneis closterium (formerly Nitzschia closterium; IC10 = 18 µg Al/L, 72-h growth rate inhibition) < mussel Mytilus edulis plannulatus (EC10 = 250 µg Al/L, 72-h embryo development) < oyster Saccostrea echinata (EC10 = 410 µg Al/L, 48-h embryo development). Toxicity to these species was the result of the dissolved aluminium forms of aluminate (Al(OH4 (-) ) and aluminium hydroxide (Al(OH)3 (0) ) although both dissolved, and particulate aluminium contributed to toxicity in the diatom Minutocellus polymorphus and green alga Dunaliella tertiolecta. In contrast, aluminium toxicity to the green flagellate alga Tetraselmis sp. was the result of particulate aluminium only. Four species, a brown macroalga (Hormosira banksii), sea urchin embryo (Heliocidaris tuberculata), and 2 juvenile fish species (Lates calcarifer and Acanthochromis polyacanthus), were not adversely affected at the highest test concentration used. © 2014 SETAC.

  5. Influence of point-of-care C-reactive protein testing on antibiotic prescription habits in primary care in the Netherlands.

    PubMed

    Schuijt, Tim J; Boss, David S; Musson, Ruben E A; Demir, Ayse Y

    2018-03-27

    Bacterial resistance to antibiotics represents a serious global challenge that is associated with high morbidity and mortality. One of the most important causes of this threat is antibiotic overuse. The Dutch College of General Practitioners (DCGP) recommends the use of point-of-care (POC) testing for C-reactive protein (CRP) in two guidelines ('Acute Cough' and 'Diverticulitis') to achieve a more sensible prescription pattern of antibiotics. To evaluate the use of POC-CRP testing in light of the DCGP guidelines and the effect of CRP measurements on antibiotic prescription policy in primary care. In a prospective observational study, which included 1756 patients, general practitioners (GPs) were asked to complete a questionnaire after every POC-CRP testing, stating the indication for performing the test, the CRP result and their decision whether or not to prescribe antibiotics. Indications were verified against the DCGP guidelines and categorized. Antibiotic prescription was evaluated in relation to CRP concentrations. Indications to perform POC-CRP test and the prescription pattern of antibiotics based on CRP value varied considerably between GPs. Differences in antibiotic prescription rate were most obvious in patients who presented with CRP values between 20 and 100 mg/l, and could in part be explained by the indication for performing POC-CRP test and patient age. Most GPs followed the DCGP guidelines and used low CRP values to underpin their decision to refrain from antibiotic prescription. Peer-based reflection on differences in POC-CRP usage and antibiotic prescription rate amongst GPs may further nourish a more critical approach to prescription of antibiotics.

  6. 2015 UK national guideline for the management of infection with Chlamydia trachomatis.

    PubMed

    Nwokolo, Nneka C; Dragovic, Bojana; Patel, Sheel; Tong, C Y William; Barker, Gary; Radcliffe, Keith

    2016-03-01

    This guideline offers recommendations on the diagnostic tests, treatment regimens and health promotion principles needed for the effective management of Chlamydia trachomatis genital infection. It covers the management of the initial presentation, as well the prevention of transmission and future infection. The guideline is aimed at individuals aged 16 years and older presenting to healthcare professionals working in departments offering Level 3 care in sexually transmitted infections management within the UK. However, the principles of the recommendations should be adopted across all levels, using local care pathways where appropriate. © The Author(s) 2016.

  7. On the Reading of Poetry in Relationship to Testing.

    ERIC Educational Resources Information Center

    Borden, Arthur R., Jr.

    1967-01-01

    Experience in evaluating responses to poetry in the Advanced Placement Examination can offer guidelines for the effective testing of students on poetry without reducing their interest in the art. For advanced secondary or first-year college students, teachers should avoid approaches and tests that are concerned with (1) extraneous biographical,…

  8. Icelandic for Adult Foreigners: Effects of Imposing an Icelandic Language Test

    ERIC Educational Resources Information Center

    Innes, Pamela; Skaptadóttir, Unnur Dís

    2017-01-01

    Legislation linking language course attendance and passage of a language test for residence visas and citizenship, respectively, was enacted in Iceland in the early 2000s. Curricular guidelines and the language test were developed as a result. Research in other countries suggests such structures cause teachers to create "de facto"…

  9. Pap Tests Every Three Years: Cost-Effective in the Long Run?

    ERIC Educational Resources Information Center

    Amschler, Denise Hope

    1983-01-01

    The American Cancer Society's guidelines, recommending that having Pap tests at three-year intervals is safe for many women, are questioned. Dangers to women with a high risk of cervical cancer, problems with faulty test results, and other gynecological problems that may be detected during pelvic examinations are discussed. (PP)

  10. Revised ESC/ESA Guidelines on non-cardiac surgery: cardiovascular assessment and management. Implications for preoperative clinical evaluation.

    PubMed

    Guarracino, F; Baldassarri, R; Priebe, H J

    2015-02-01

    Each year, an increasing number of elderly patients with cardiovascular disease undergoing non-cardiac surgery require careful perioperative management to minimize the perioperative risk. Perioperative cardiovascular complications are the strongest predictors of morbidity and mortality after major non-cardiac surgery. A Joint Task Force of the European Society of Cardiology (ESC) and the European Society of Anaesthesiology (ESA) has recently published revised Guidelines on the perioperative cardiovascular management of patients scheduled to undergo non-cardiac surgery, which represent the official position of the ESC and ESA on various aspects of perioperative cardiac care. According to the Guidelines effective perioperative cardiac management includes preoperative risk stratification based on preoperative assessment of functional capacity, type of surgery, cardiac risk factors, and cardiovascular function. The ESC/ESA Guidelines discourage indiscriminate routine preoperative cardiac testing, because it is time- and cost-consuming, resource-limiting, and does not improve perioperative outcome. They rather emphasize the importance of individualized preoperative cardiac evaluation and the cooperation between anesthesiologists and cardiologists. We summarize the relevant changes of the 2014 Guidelines as compared to the previous ones, with particular emphasis on preoperative cardiac testing.

  11. Evidence-based care of older people with suspected cognitive impairment in general practice: protocol for the IRIS cluster randomised trial.

    PubMed

    McKenzie, Joanne E; French, Simon D; O'Connor, Denise A; Mortimer, Duncan S; Browning, Colette J; Russell, Grant M; Grimshaw, Jeremy M; Eccles, Martin P; Francis, Jill J; Michie, Susan; Murphy, Kerry; Kossenas, Fiona; Green, Sally E

    2013-08-19

    Dementia is a common and complex condition. Evidence-based guidelines for the management of people with dementia in general practice exist; however, detection, diagnosis and disclosure of dementia have been identified as potential evidence-practice gaps. Interventions to implement guidelines into practice have had varying success. The use of theory in designing implementation interventions has been limited, but is advocated because of its potential to yield more effective interventions and aid understanding of factors modifying the magnitude of intervention effects across trials. This protocol describes methods of a randomised trial that tests a theory-informed implementation intervention that, if effective, may provide benefits for patients with dementia and their carers. This trial aims to estimate the effectiveness of a theory-informed intervention to increase GPs' (in Victoria, Australia) adherence to a clinical guideline for the detection, diagnosis, and management of dementia in general practice, compared with providing GPs with a printed copy of the guideline. Primary objectives include testing if the intervention is effective in increasing the percentage of patients with suspected cognitive impairment who receive care consistent with two key guideline recommendations: receipt of a i) formal cognitive assessment, and ii) depression assessment using a validated scale (primary outcomes for the trial). The design is a parallel cluster randomised trial, with clusters being general practices. We aim to recruit 60 practices per group. Practices will be randomised to the intervention and control groups using restricted randomisation. Patients meeting the inclusion criteria, and GPs' detection and diagnosis behaviours directed toward these patients, will be identified and measured via an electronic search of the medical records nine months after the start of the intervention. Practitioners in the control group will receive a printed copy of the guideline. In addition to receipt of the printed guideline, practitioners in the intervention group will be invited to participate in an interactive, opinion leader-led, educational face-to-face workshop. The theory-informed intervention aims to address identified barriers to and enablers of implementation of recommendations. Researchers responsible for identifying the cohort of patients with suspected cognitive impairment, and their detection and diagnosis outcomes, will be blind to group allocation. Australian New Zealand Clinical Trials Registry: ACTRN12611001032943 (date registered 28 September, 2011).

  12. Comments from the Behavioral Teratology Committee of the Japanese Teratology Society on OECD guideline for the testing of chemicals, proposal for a new guideline 426, developmental neurotoxicity study, draft document (September 2003).

    PubMed

    Fukui, Yoshihiro; Ema, Makoto; Fujiwara, Michio; Higuchi, Hashihiro; Inouye, Minoru; Iwase, Takayuki; Kihara, Takahide; Nishimura, Tatsuya; Oi, Akihide; Ooshima, Yojiro; Otani, Hiroki; Shinomiya, Mitsuhiro; Sugioka, Kozo; Yamano, Tsunekazu; Yamashita, Keisuke H; Tanimura, Takashi

    2004-09-01

    In September 2003, a new revision of the draft guideline (Organization for Economic Co-operation and Development [OECD] Guideline for the Testing of Chemicals, Proposal for a New Guideline 426, Developmental Neurotoxicity Study) was distributed. The draft guideline consists of 51 paragraphs and an appendix. The National Coordinators were requested to arrange national expert reviews of the guideline proposal in their member countries. The member of the Behavioral Teratology (BT) Committee of the Japanese Teratology Society (JTS) reviewed, discussed and commented on the draft Test Guideline proposal. The BT Committee of the JTS also commented that the International Collaborative Study to validate this protocol should be definitely performed. These comments were sent to the OECD Secretariat. The BT Committee of the JTS expects that the comments are useful for further discussion.

  13. Implementing tobacco use treatment guidelines in public health dental clinics in New York City.

    PubMed

    Shelley, Donna; Anno, Jaime; Tseng, Tuo-Yen; Calip, Greg; Wedeles, John; Lloyd, Madeleine; Wolff, Mark S

    2011-04-01

    In this study we evaluated the effect of a multicomponent intervention to implement the Public Health Service (PHS) guideline Treating Tobacco Use and Dependence in six randomly selected dental clinics in New York University's College of Dentistry. The main outcome measure-provider adherence to tobacco use treatment guidelines-was assessed by auditing a random selection of patient charts pre (698) and post (641) intervention. The intervention components included a chart reminder and referral system, free nicotine replacement therapy (NRT), and provider training and feedback. The results showed that rates of screening for tobacco use did not change between pre and post test chart audits. However, providers were significantly more likely to offer advice (28.4 percent pre, 49 percent post), assess readiness to quit (17.8 percent pre, 29.9 percent post), and offer assistance (6.5 percent pre and 15.6 percent post) in the post test period. Increases in NRT distribution were associated with booster training sessions but declined in the time periods between those trainings. Research is needed to further define sustainable strategies for implementing tobacco use treatment in dental clinics. The results of this study suggest the feasibility and effectiveness of using a tailored multicomponent approach to implement tobacco use treatment guidelines in dental clinics.

  14. New Approaches in International Guidelines for Genetic Toxicology Assays: Latest Updates on OECD Guidelines

    EPA Science Inventory

    In March 2010, the 22nd meeting of the Working Group of National Coordinators of the OECD Test Guidelines Programme (WNT) approved a project for updating the Test Guidelines on genotoxicity, with Canada, the Netherlands, France and the USA identified as lead countries for this wo...

  15. School Hearing Test Program.

    ERIC Educational Resources Information Center

    Environmental Protection Agency, Washington, DC. Office of Noise Abatement and Control.

    The document offers guidelines for administration of the Hearing Test Noise Education Program, a program to teach students the harmful effects of excessive moise on their hearing and learning ability. Section 1 outlines the program strategy in terms of program initiation, suggested program coordination, suggested coordinator's responsibilities,…

  16. Evaluation of a tailored, multi-component intervention for implementation of evidence-based clinical practice guidelines in primary care physical therapy: a non-randomized controlled trial.

    PubMed

    Bernhardsson, Susanne; Larsson, Maria E H; Eggertsen, Robert; Olsén, Monika Fagevik; Johansson, Kajsa; Nilsen, Per; Nordeman, Lena; van Tulder, Maurits; Öberg, Birgitta

    2014-03-04

    Clinical practice guidelines are important for transmitting research findings into practice and facilitating the application of evidence-based practice (EBP). There is a paucity of knowledge about the impact of guideline implementation strategies in primary care physical therapy. The aim of this study was to evaluate the effect of a guideline implementation intervention in primary care physical therapy in western Sweden. An implementation strategy based on theory and current evidence was developed. A tailored, multi-component implementation intervention, addressing earlier identified determinants, was carried out in three areas comprising 28 physical therapy practices including 277 physical therapists (PTs) (intervention group). In two adjacent areas, 171 PTs at 32 practices received no intervention (control group). The core component of the intervention was an implementation seminar with group discussions. Among other components were a website and email reminders. Data were collected at baseline and follow-up with a web-based questionnaire. Primary outcomes were the self-reported awareness of, knowledge of, access to, and use of guidelines. Secondary outcomes were self-reported attitudes toward EBP and guidelines. Analyses were performed using Pearson's χ2 test and approximative z-test. 168 PTs (60.6%) in the intervention group and 88 PTs (51.5%) in the control group responded to the follow-up questionnaire. 186/277 PTs (67.1%) participated in the implementation seminars, of which 97 (52.2%) responded. The proportions of PTs reporting awareness of (absolute difference in change 20.6%, p = 0.023), knowledge where to find (20.4%, p = 0.007), access to (21.7%, p < 0.001), and frequent use of (9.5%, NS) guidelines increased more in the intervention group than in the control group. The proportion of PTs reporting frequent guideline use after participation in the implementation seminar was 15.2% (p = 0.043) higher than the proportion in the control group. A higher proportion considered EBP helpful in decision making (p = 0.018). There were no other significant differences in secondary outcomes. A tailored, theory- and evidence-informed, multi-component intervention for the implementation of clinical practice guidelines had a modest, positive effect on awareness of, knowledge of, access to, and use of guidelines, among PTs in primary care in western Sweden. In general, attitudes to EBP and guidelines were not affected.

  17. Influence of analytical bias and imprecision on the number of false positive results using Guideline-Driven Medical Decision Limits.

    PubMed

    Hyltoft Petersen, Per; Klee, George G

    2014-03-20

    Diagnostic decisions based on decision limits according to medical guidelines are different from the majority of clinical decisions due to the strict dichotomization of patients into diseased and non-diseased. Consequently, the influence of analytical performance is more critical than for other diagnostic decisions where much other information is included. The aim of this opinion paper is to investigate consequences of analytical quality and other circumstances for the outcome of "Guideline-Driven Medical Decision Limits". Effects of analytical bias and imprecision should be investigated separately and analytical quality specifications should be estimated accordingly. Use of sharp decision limits doesn't consider biological variation and effects of this variation are closely connected with the effects of analytical performance. Such relationships are investigated for the guidelines for HbA1c in diagnosis of diabetes and in risk of coronary heart disease based on serum cholesterol. The effects of a second sampling in diagnosis give dramatic reduction in the effects of analytical quality showing minimal influence of imprecision up to 3 to 5% for two independent samplings, whereas the reduction in bias is more moderate and a 2% increase in concentration doubles the percentage of false positive diagnoses, both for HbA1c and cholesterol. An alternative approach comes from the current application of guidelines for follow-up laboratory tests according to clinical procedure orders, e.g. frequency of parathyroid hormone requests as a function of serum calcium concentrations. Here, the specifications for bias can be evaluated from the functional increase in requests for increasing serum calcium concentrations. In consequence of the difficulties with biological variation and the practical utilization of concentration dependence of frequency of follow-up laboratory tests already in use, a kind of probability function for diagnosis as function of the key-analyte is proposed. Copyright © 2013 Elsevier B.V. All rights reserved.

  18. Reprint of "Influence of analytical bias and imprecision on the number of false positive results using Guideline-Driven Medical Decision Limits".

    PubMed

    Hyltoft Petersen, Per; Klee, George G

    2014-05-15

    Diagnostic decisions based on decision limits according to medical guidelines are different from the majority of clinical decisions due to the strict dichotomization of patients into diseased and non-diseased. Consequently, the influence of analytical performance is more critical than for other diagnostic decisions where much other information is included. The aim of this opinion paper is to investigate consequences of analytical quality and other circumstances for the outcome of "Guideline-Driven Medical Decision Limits". Effects of analytical bias and imprecision should be investigated separately and analytical quality specifications should be estimated accordingly. Use of sharp decision limits doesn't consider biological variation and effects of this variation are closely connected with the effects of analytical performance. Such relationships are investigated for the guidelines for HbA1c in diagnosis of diabetes and in risk of coronary heart disease based on serum cholesterol. The effects of a second sampling in diagnosis give dramatic reduction in the effects of analytical quality showing minimal influence of imprecision up to 3 to 5% for two independent samplings, whereas the reduction in bias is more moderate and a 2% increase in concentration doubles the percentage of false positive diagnoses, both for HbA1c and cholesterol. An alternative approach comes from the current application of guidelines for follow-up laboratory tests according to clinical procedure orders, e.g. frequency of parathyroid hormone requests as a function of serum calcium concentrations. Here, the specifications for bias can be evaluated from the functional increase in requests for increasing serum calcium concentrations. In consequence of the difficulties with biological variation and the practical utilization of concentration dependence of frequency of follow-up laboratory tests already in use, a kind of probability function for diagnosis as function of the key-analyte is proposed. Copyright © 2014. Published by Elsevier B.V.

  19. Genetic Testing for Minors: Comparison between Italian and British Guidelines

    PubMed Central

    Tozzo, Pamela; Caenazzo, Luciana; Rodriguez, Daniele

    2012-01-01

    Genetic testing in children raises many important ethical, legal, and social issues. One of the main concerns is the ethically inappropriate genetic testing of minors. Various European countries established professional guidelines which reflect the different countries perspectives regarding the main ethical issues involved. In this paper, we analyze the Italian and the British guidelines by highlighting differences and similarities. We discuss presymptomatic, predictive, and carrier testing because we consider them to be the more ethically problematic types of genetic testing in minors. In our opinion, national guidelines should take into account the different needs in clinical practice. At the same time, in the case of genetic testing the national and supranational protection of minors could be strengthened by approving guidelines based on a common framework of principles and values. We suggest that the Oviedo Convention could represent an example of such a common framework or, at least, it could lead to articulate it. PMID:22567400

  20. Optimizing the design of a reproduction toxicity test with the pond snail Lymnaea stagnalis.

    PubMed

    Charles, Sandrine; Ducrot, Virginie; Azam, Didier; Benstead, Rachel; Brettschneider, Denise; De Schamphelaere, Karel; Filipe Goncalves, Sandra; Green, John W; Holbech, Henrik; Hutchinson, Thomas H; Faber, Daniel; Laranjeiro, Filipe; Matthiessen, Peter; Norrgren, Leif; Oehlmann, Jörg; Reategui-Zirena, Evelyn; Seeland-Fremer, Anne; Teigeler, Matthias; Thome, Jean-Pierre; Tobor Kaplon, Marysia; Weltje, Lennart; Lagadic, Laurent

    2016-11-01

    This paper presents the results from two ring-tests addressing the feasibility, robustness and reproducibility of a reproduction toxicity test with the freshwater gastropod Lymnaea stagnalis (RENILYS strain). Sixteen laboratories (from inexperienced to expert laboratories in mollusc testing) from nine countries participated in these ring-tests. Survival and reproduction were evaluated in L. stagnalis exposed to cadmium, tributyltin, prochloraz and trenbolone according to an OECD draft Test Guideline. In total, 49 datasets were analysed to assess the practicability of the proposed experimental protocol, and to estimate the between-laboratory reproducibility of toxicity endpoint values. The statistical analysis of count data (number of clutches or eggs per individual-day) leading to ECx estimation was specifically developed and automated through a free web-interface. Based on a complementary statistical analysis, the optimal test duration was established and the most sensitive and cost-effective reproduction toxicity endpoint was identified, to be used as the core endpoint. This validation process and the resulting optimized protocol were used to consolidate the OECD Test Guideline for the evaluation of reproductive effects of chemicals in L. stagnalis. Copyright © 2016 Elsevier Inc. All rights reserved.

  1. Consensus guidelines: improving the delivery of clinical preventive services.

    PubMed

    Ayres, Cynthia G; Griffith, Hurdis M

    2008-01-01

    Medical directors from the largest competing health plans in the state came together in a noncompetitive way to collaborate on improving the delivery of clinical preventive service (CPS) among their provider base. They identified one consistent set of CPS guidelines based on U.S. Preventive Services Task Force recommendations, the health plan consensus guidelines (HPCG), that they could endorse as priority for guideline implementation. The purposes of this study were to assess clinicians' knowledge and use of CPS recommendations as a guide to delivering preventive care services to their patients and, most importantly, to test the effectiveness of providing the HPCG to clinicians in an effort to increase knowledge and use of CPS guidelines. Within-subjects repeated-measures design was used. We hypothesized an increase in clinician's knowledge and use of CPS after the provision of the HPCG. Survey methodology, including two surveys that assessed clinicians' knowledge and use of CPS in practice, was used. Health plan clinician databases were obtained from the health plans that participated in the development of the HPCG. Health plan clinicians directly involved in delivering preventive services were invited to participate in the study. Final sample included 163 clinicians. Spearman's rho correlation coefficients were determined to examine the relationships between clinician's knowledge and clinician's use of CPS guidelines. Differences between knowledge and use of CPS before and after HPCG were examined by t tests. No difference was found in the familiarity with U.S. Preventive Services Task Force guidelines before and after receipt of HPCG. However, clinician's use increased significantly. A consistent set of CPS guidelines provided by competing health plans can improve the delivery of CPS among contracted health plan clinicians. This approach provides a template for competing health plans nationwide to come to consensus on guidelines that support clinicians in the delivery of CPS ().

  2. Guidelines for evaluation and treatment of lead poisoning of wild raptors

    USGS Publications Warehouse

    Fallon, Jesse A.; Redig, Patrick; Miller, Tricia A.; Lanzone, Michael J.; Katzner, Todd

    2017-01-01

    Lead poisoning is a threat to birds, particularly scavenging birds of prey. With the availability of portable lead-testing kits, an increasing number of field researchers are testing wild-caught birds, in situ, for lead poisoning. We describe guidelines for evaluation of lead toxicity in wild raptors by outlining field testing of blood-lead concentrations, presenting criteria for removing a lead-poisoned bird from the wild for treatment, and suggesting strategies for effective treatment of lead intoxicated raptors. Field testing of birds is most commonly accomplished via portable electrochemical analysis of blood; visual observation of condition alone may provide insufficient evidence upon which to make a decision about lead poisoning. Our intended audience is not only the avian research community, but also rehabilitation facilities that may receive apparently uninjured birds. Best practices suggest that birds whose blood-lead levels are <40 μg/dL be released back to the wild as soon as possible after capture. The decision to release or treat birds with blood-lead levels between 40 μg/dL and 60 μg/dL should be made based on the presence of clinical signs of poisoning and relevant biological characteristics (e.g., breeding status). Finally, birds with blood-lead levels >60 μg/dL are potentially lethally poisoned and best served if removed from the wild for appropriate treatment at a licensed rehabilitation facility and later released. We present guidelines for decision-making when treating lead poisoning of wild raptors. Future work based on experimental studies will clarify the role of lead poisoning for specific species and be important to refine these guidelines to improve effectiveness.

  3. How meaningful are risk determinations in the absence of a complete dataset? Making the case for publishing standardized test guideline and ‘no effect’ studies for evaluating the safety of nanoparticulates versus spurious ‘high effect’ results from single investigative studies

    NASA Astrophysics Data System (ADS)

    Warheit, David B.; Donner, E. Maria

    2015-06-01

    A recent review article critically assessed the effectiveness of published research articles in nanotoxicology to meaningfully address health and safety issues for workers and consumers. The main conclusions were that, based on a number of flaws in study designs, the potential risk from exposures to nanomaterials is highly exaggerated, and that no ‘nano-specific’ adverse effects, different from exposures to bulk particles, have been convincingly demonstrated. In this brief editorial we focus on a related tangential issue which potentially compromises the integrity of basic risk science. We note that some single investigation studies report specious toxicity findings, which make the conclusions more alarming and attractive and publication worthy. In contrast, the standardized, carefully conducted, ‘guideline study results’ are often ignored because they can frequently report no adverse effects; and as a consequence are not considered as novel findings for publication purposes, and therefore they are never considered as newsworthy in the popular press. Yet it is the Organization for Economic Cooperation and Development (OECD) type test guideline studies that are the most reliable for conducting risk assessments. To contrast these styles and approaches, we present the results of a single study which reports high toxicological effects in rats following low-dose, short-term oral exposures to nanoscale titanium dioxide particles concomitant with selective investigative analyses. Alternatively, the findings of OECD test guideline 408, standardized guideline oral toxicity studies conducted for 90 days at much higher doses (1000 mg kg-1) in male and female rats demonstrated no adverse effects following a very thorough and complete clinical chemical, as well as histopathological evaluation of all of the relevant organs in the body. This discrepancy in study findings is not reconciled by the fact that several biokinetic studies in rats and humans demonstrate little or no uptake of nanoscale or pigment-grade TiO2 particles following oral exposures. We conclude that to develop a competent risk assessment profile, results derived from standardized, guideline-type studies, and even ‘no effect’ study findings provide critically useful input for assessing safe levels of exposure; and should, in principle, be readily acceptable for publication in peer-reviewed toxicology journals. This is a necessary prerequisite for developing a complete dataset for risk assessment determinations.

  4. A new impetus for guideline development and implementation: construction and evaluation of a toolbox.

    PubMed

    Hilbink, Mirrian A H W; Ouwens, Marielle M T J; Burgers, Jako S; Kool, Rudolf B

    2014-03-19

    In the last decade, guideline organizations faced a number of problems, including a lack of standardization in guideline development methods and suboptimal guideline implementation. To contribute to the solution of these problems, we produced a toolbox for guideline development, implementation, revision, and evaluation. All relevant guideline organizations in the Netherlands were approached to prioritize the topics. We sent out a questionnaire and discussed the results at an invitational conference. Based on consensus, twelve topics were selected for the development of new tools. Subsequently, working groups were composed for the development of the tools. After development of the tools, their draft versions were pilot tested in 40 guideline projects. Based on the results of the pilot tests, the tools were refined and their final versions were presented. The vast majority of organizations involved in pilot testing of the tools reported satisfaction with using the tools. Guideline experts involved in pilot testing of the tools proposed a variety of suggestions for the implementation of the tools. The tools are available in Dutch and in English at a web-based platform on guideline development and implementation (http://www.ha-ring.nl). A collaborative approach was used for the development and evaluation of a toolbox for development, implementation, revision, and evaluation of guidelines. This approach yielded a potentially powerful toolbox for improving the quality and implementation of Dutch clinical guidelines. Collaboration between guideline organizations within this project led to stronger linkages, which is useful for enhancing coordination of guideline development and implementation and preventing duplication of efforts. Use of the toolbox could improve quality standards in the Netherlands, and might facilitate the development of high-quality guidelines in other countries as well.

  5. 40 CFR 798.4100 - Dermal sensitization.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... system selected is recommended; (ii) Animals may act as their own controls or groups of induced animals... CONTROL ACT (CONTINUED) HEALTH EFFECTS TESTING GUIDELINES Specific Organ/Tissue Toxicity § 798.4100 Dermal... hypersensitive state is developed. (3) Induction exposure is an experimental exposure of a subject to a test...

  6. 40 CFR 798.4100 - Dermal sensitization.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... system selected is recommended; (ii) Animals may act as their own controls or groups of induced animals... CONTROL ACT (CONTINUED) HEALTH EFFECTS TESTING GUIDELINES Specific Organ/Tissue Toxicity § 798.4100 Dermal... hypersensitive state is developed. (3) Induction exposure is an experimental exposure of a subject to a test...

  7. 40 CFR 798.4100 - Dermal sensitization.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... system selected is recommended; (ii) Animals may act as their own controls or groups of induced animals... CONTROL ACT (CONTINUED) HEALTH EFFECTS TESTING GUIDELINES Specific Organ/Tissue Toxicity § 798.4100 Dermal... hypersensitive state is developed. (3) Induction exposure is an experimental exposure of a subject to a test...

  8. 40 CFR 798.4100 - Dermal sensitization.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... system selected is recommended; (ii) Animals may act as their own controls or groups of induced animals... CONTROL ACT (CONTINUED) HEALTH EFFECTS TESTING GUIDELINES Specific Organ/Tissue Toxicity § 798.4100 Dermal... hypersensitive state is developed. (3) Induction exposure is an experimental exposure of a subject to a test...

  9. Australian and New Zealand Anaesthetic Allergy Group Perioperative Anaphylaxis Investigation Guidelines.

    PubMed

    Scolaro, R J; Crilly, H M; Maycock, E J; McAleer, P T; Nicholls, K A; Rose, M A; The, Rih

    2017-09-01

    These guidelines are a consensus document developed by a working party of the Australian and New Zealand Anaesthetic Allergy Group (ANZAAG) to provide an approach to the investigation of perioperative anaphylaxis. They focus primarily on the use of skin testing as it is the investigation with the greatest clinical utility for the identification of the likely causative agent and potentially safer alternatives. The practicalities and process of skin testing, its limitations, and the place of other tests are discussed. These guidelines also address the roles of graded challenge and in vitro testing. The implications of anaphylaxis associated with neuromuscular blocking agents, beta-lactam antibiotics, local anaesthetic agents and chlorhexidine are discussed. Evidence for the recommendations is derived from literature searches using the words skin test, allergy, anaphylaxis, anaesthesia, and each of the individual agents listed in these guidelines. The individual articles were then reviewed for suitability for inclusion in these guidelines. Where evidence was not strong, as is the situation for many perioperative agents, expert consensus from the ANZAAG working party was used. These guidelines are intended for use by specialists involved in the investigation of perioperative allergy. They have been approved following peer review by members of ANZAAG and are available on the ANZAAG website: http://www.anzaag.com/anaphylaxis-management/testing-guidelines.pdf.

  10. Identification of individuals at risk for Lynch syndrome using targeted evaluations and genetic testing: National Society of Genetic Counselors and the Collaborative Group of the Americas on Inherited Colorectal Cancer joint practice guideline.

    PubMed

    Weissman, Scott M; Burt, Randall; Church, James; Erdman, Steve; Hampel, Heather; Holter, Spring; Jasperson, Kory; Kalady, Matt F; Haidle, Joy Larsen; Lynch, Henry T; Palaniappan, Selvi; Wise, Paul E; Senter, Leigha

    2012-08-01

    Identifying individuals who have Lynch syndrome (LS) involves a complex diagnostic work up that includes taking a detailed family history and a combination of various genetic and immunohistochemical tests. The National Society of Genetic Counselors (NSGC) and the Collaborative Group of the Americas on Inherited Colorectal Cancer (CGA-ICC) have come together to publish this clinical practice testing guideline for the evaluation of LS. The purpose of this practice guideline is to provide guidance and a testing algorithm for LS as well as recommendations on when to offer testing. This guideline does not replace a consultation with a genetics professional. This guideline includes explanations in support of this and a summary of background data. While this guideline is not intended to serve as a review of LS, it includes a discussion of background information on LS, and cites a number of key publications which should be reviewed for a more in-depth understanding of LS. These guidelines are intended for genetic counselors, geneticists, gastroenterologists, surgeons, medical oncologists, obstetricians and gynecologists, nurses and other healthcare providers who evaluate patients for LS.

  11. Tools developed and disseminated by guideline producers to promote the uptake of their guidelines.

    PubMed

    Flodgren, Gerd; Hall, Amanda M; Goulding, Lucy; Eccles, Martin P; Grimshaw, Jeremy M; Leng, Gillian C; Shepperd, Sasha

    2016-08-22

    The uptake of clinical practice guidelines (CPGs) is inconsistent, despite their potential to improve the quality of health care and patient outcomes. Some guideline producers have addressed this problem by developing tools to encourage faster adoption of new guidelines. This review focuses on the effectiveness of tools developed and disseminated by guideline producers to improve the uptake of their CPGs. To evaluate the effectiveness of implementation tools developed and disseminated by guideline producers, which accompany or follow the publication of a CPG, to promote uptake. A secondary objective is to determine which approaches to guideline implementation are most effective. We searched the Cochrane Effective Practice and Organisation of Care (EPOC) Group Specialised Register, Cochrane Central Register of Controlled Trials (CENTRAL); NHS Economic Evaluation Database, HTA Database; MEDLINE and MEDLINE In-Process and other non-indexed citations; Embase; PsycINFO; CINAHL; Dissertations and Theses, ProQuest; Index to Theses; Science Citation Index Expanded, ISI Web of Knowledge; Conference Proceedings Citation Index - Science, ISI Web of Knowledge; Health Management Information Consortium (HMIC), and NHS Evidence up to February 2016. We also searched trials registers, reference lists of included studies and relevant websites. We included randomised controlled trials (RCTs) and cluster-RCTs, controlled before-and-after studies (CBAs) and interrupted time series (ITS) studies evaluating the effects of guideline implementation tools developed by recognised guideline producers to improve the uptake of their own guidelines. The guideline could target any clinical area. Two review authors independently extracted data and assessed the risk of bias of each included study using the Cochrane 'Risk of bias' criteria. We graded our confidence in the evidence using the approach recommended by the GRADE working group. The clinical conditions targeted and the implementation tools used were too heterogenous to combine data for meta-analysis. We report the median absolute risk difference (ARD) and interquartile range (IQR) for the main outcome of adherence to guidelines. We included four cluster-RCTs that were conducted in the Netherlands, France, the USA and Canada. These studies evaluated the effects of tools developed by national guideline producers to implement their CPGs. The implementation tools evaluated targeted healthcare professionals; none targeted healthcare organisations or patients.One study used two short educational workshops tailored to barriers. In three studies the intervention consisted of the provision of paper-based educational materials, order forms or reminders, or both. The clinical condition, type of healthcare professional, and behaviour targeted by the CPG varied across studies.Two of the four included studies reported data on healthcare professionals' adherence to guidelines. A guideline tool developed by the producers of a guideline probably leads to increased adherence to the guidelines; median ARD (IQR) was 0.135 (0.115 and 0.159 for the two studies respectively) at an average four-week follow-up (moderate certainty evidence), which indicates a median 13.5% greater adherence to guidelines in the intervention group. Providing healthcare professionals with a tool to improve implementation of a guideline may lead to little or no difference in costs to the health service. Implementation tools developed by recognised guideline producers probably lead to improved healthcare professionals' adherence to guidelines in the management of non-specific low back pain and ordering thyroid-function tests. There are limited data on the relative costs of implementing these interventions.There are no studies evaluating the effectiveness of interventions targeting the organisation of care (e.g. benchmarking tools, costing templates, etc.), or for mass media interventions. We could not draw any conclusions about our second objective, the comparative effectiveness of implementation tools, due to the small number of studies, the heterogeneity between interventions, and the clinical conditions that were targeted.

  12. EPA’s Nonmonotonic Dose Response Curve Workplan

    EPA Pesticide Factsheets

    EPA’s standard guidelines for reproductive and developmental toxicity testing and risk assessment are needed in order to detect and characterize low-dose adverse effects of endocrine disrupting chemicals (EDCs).

  13. 17alpha-methyltestosterone: 28-day oral toxicity study in the rat based on the "Enhanced OECD Test Guideline 407" to detect endocrine effects.

    PubMed

    Wason, Sheila; Pohlmeyer-Esch, Gabriele; Pallen, Catherine; Palazzi, Xavier; Espuña, Gemma; Bars, Remi

    2003-11-05

    A 28-day oral gavage toxicity study in the rat with 17alpha-methyltestosterone was conducted as part of the international validation exercise on the modified Enhanced OECD Test Guideline 407 (Organisation for Economic Co-operation and Development, Paris). Special emphasis was placed on the endocrine mediated effects exerted by 17alpha-methyltestosterone, a potent androgen agonist. The test compound was administered daily by oral gavage for at least 28 days to groups of 7-week-old-Wistar rats. Dose levels were 0, 10, 40 and 200 mg/kg body weight per day for males and 0, 10, 100 and 600 mg/kg body weight per day for females. In addition, and outside the remit of the enhanced protocol, testosterone levels in males, oestradiol levels in females and luteinizing hormone (LH) levels in both sexes were measured, to provide a broader profile on the hormonally mediated effects of 17alpha-methyltestosterone. Furthermore, stage-specific quantification of Terminal deoxynucleotidyl transferase-mediated dUTP Nick-End Labeling (TUNEL)-labeled germ cells (apoptotic germ cells) in the seminiferous tubules was also performed, in an effort to demonstrate the precise stages in the spermatogenic cycle 17alpha-methyltestosterone exerts its effect. In this study, the most critical additional parameters contained in the Enhanced OECD Test Guideline 407 for the detection of endocrine disruption were considered to be the histopathological assessment and organ weight data of endocrine-related tissues. Beyond the scope of this validation exercise, an increase in apoptosis in specific germ cell types was detected using the TUNEL assay in male rats treated at 200 and 40 mg/kg.

  14. Measure Guideline: Combustion Safety for Natural Draft Appliances Using Indoor Air

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

    Brand, L.

    2014-04-01

    This measure guideline covers how to assess and carry out the combustion safety procedures for appliances and heating equipment that uses indoor air for combustion in low-rise residential buildings. Only appliances installed in the living space, or in an area freely communicating with the living space, vented alone or in tandem with another appliance are considered here. A separate measure guideline addresses combustion appliances located either within the living space in enclosed closets or side rooms or outside the living space in an adjacent area like an attic or garage that use outdoor air for combustion. This document is formore » inspectors, auditors, and technicians working in homes where energy upgrades are being conducted whether or not air infiltration control is included in the package of measures being applied. In the indoor combustion air case, guidelines summarized here are based on language provided in several of the codes to establish minimum requirements for the space using simplified prescriptive measures. In addition, building performance testing procedures are provided by testing agencies. The codes in combination with the test procedures offer comprehensive combustion safety coverage to address safety concerns, allowing inexperienced residential energy retrofit inspectors to effectively address combustion safety issues and allow energy retrofits to proceed.« less

  15. C-B3-03: Development and Pilot Testing of Guidelines to Monitor High-Risk Medications in the Ambulatory Setting

    PubMed Central

    Tjia, Jennifer; Field, Terry; Garber, Lawrence; Raebel, Marsha; Donovan, Jennifer; Kanaan, Abir; Fischer, Shira; Gagne, Shawn; Zhao, Yanfang; Fuller, Jackie; Gurwitz, Jerry

    2010-01-01

    Background: Inadequate laboratory monitoring of high-risk medications contributes to preventable adverse drug events. One barrier to appropriate monitoring is lack of standardized monitoring guidelines. The study aims were to develop guidelines to monitor high-risk medications and to assess the prevalence of laboratory testing for these medications in a multispecialty group practice. Methods: We developed guidelines for laboratory monitoring of high-risk medications as part of a patient safety intervention trial. An advisory committee of national experts and local leaders (clinicians, pharmacists, pharmacoepidemiologists, and patient safety experts) used a two-round, internet-based Delphi process to select guideline medications based on the importance of monitoring for efficacy, safety, and drug-drug interactions. Test frequency recommendations were developed by academic pharmacists based on literature review and local interdisciplinary consensus. To estimate the potential impact of the intervention, we determined the prevalence of high-risk drug dispensings and laboratory testing for guideline medications between January 1, 2008 and July 31, 2008. Results: Consensus on medications to include in the guidelines was achieved in two rounds. Final guidelines included 35 drugs/drug classes and 61 laboratory tests. The prevalence of monitoring ranged from <50% to >90%, with infrequently prescribed drugs having a lower prevalence of recommended testing. When more than one test was recommended for a selected medication, monitoring within a medication sometimes differed by > 50%. Conclusions: Even among drugs where there is general consensus that laboratory monitoring is important, prevalence of monitoring is highly variable. Further, infrequently prescribed medications are at higher risk for poor monitoring.

  16. The challenge of defining and treating anemia and iron deficiency in pregnancy: A study of New Zealand midwives' management of iron status in pregnancy and the postpartum period.

    PubMed

    Calje, Esther; Skinner, Joan

    2017-06-01

    Early recognition and management of low maternal iron status is associated with improved maternal, fetal, and neonatal outcomes. However, existing international guidelines for the testing and management of maternal iron-deficiency anemia are variable, with no national guideline for New Zealand midwives. Clinical management is complicated by normal physiological hemodilution, and complicated further by the effects of inflammation on iron metabolism, especially in populations with a high prevalence of obesity or infection. This study describes how midwives in one New Zealand area diagnose and treat anemia and iron deficiency, in the absence of established guidelines. Data on demographics, laboratory results, and documented clinical management were retrospectively collected from midwives (n=21) and women (n=189), from September to December 2013. Analysis was predominantly descriptive. A secondary analysis of iron status and body mass index (BMI) was undertaken. A total of 46% of 186 women, with hemoglobin testing at booking, did not have ferritin tested; 86% (of 385) of ferritin tests were not concurrently tested with C-reactive protein. Despite midwives prescribing iron for 48.7% of second trimester women, 47.1% still had low iron status before birth. Only 22.8% of women had hemoglobin testing postpartum. There was a significant difference between third trimester median ferritin levels in women with BMI ≥25.00 (14 μg/L) and BMI <25.00 (18 μg/L) (P=.05). There was a wide range in the midwives' practice. Maternal iron status was difficult to categorize, because of inconsistent testing. This study indicates the need for an evidence-based clinical guideline for New Zealand midwives and maternity care providers. © 2017 Wiley Periodicals, Inc.

  17. Technical standards and guidelines: molecular genetic testing for ultra-rare disorders.

    PubMed

    Maddalena, Anne; Bale, Sherri; Das, Soma; Grody, Wayne; Richards, Sue

    2005-10-01

    These standards and guidelines are designed primarily as an educational resource for clinical laboratory geneticists to help them provide quality clinical laboratory genetic services. Adherence to these standards and guidelines does not necessarily ensure a successful medical outcome. These standards and guidelines should not be considered inclusive of all proper procedures and tests or exclusive of other procedures and tests that are reasonably directed to obtaining the same results. In determining the propriety of any specific procedure or test, the clinical molecular geneticist should apply his or her own professional judgment to the specific clinical circumstances presented by the individual patient or specimen. It may be prudent, however, to document in the laboratory record the rationale for any significant deviation from these standards and guidelines.

  18. Guidelines for Using the "Q" Test in Meta-Analysis

    ERIC Educational Resources Information Center

    Maeda, Yukiko; Harwell, Michael R.

    2016-01-01

    The "Q" test is regularly used in meta-analysis to examine variation in effect sizes. However, the assumptions of "Q" are unlikely to be satisfied in practice prompting methodological researchers to conduct computer simulation studies examining its statistical properties. Narrative summaries of this literature are available but…

  19. Haemorrhagia post partum; an implementation study on the evidence-based guideline of the Dutch Society of Obstetrics and Gynaecology (NVOG) and the MOET (Managing Obstetric Emergencies and Trauma-course) instructions; the Fluxim study

    PubMed Central

    2010-01-01

    Background One of the most important causes of maternal mortality and severe morbidity worldwide is post partum haemorrhage (PPH). Factors as substandard care are frequently reported in the international literature and there are similar reports in the Netherlands. The incidence of PPH in the Dutch population is 5% containing 10.000 women a year. The introduction of an evidence-based guideline on PPH by the Dutch society of Obstetrics and Gynaecology (NVOG) and the initiation of the MOET course (Managing Obstetrics Emergencies and Trauma) did not lead to a reduction of PPH. This implies the possibility of an incomplete implementation of both the NVOG guideline and MOET-instructions. Therefore, the aim of this study is to develop and test a tailored strategy to implement both the NVOG guideline and MOET-instructions Methods/Design One step in the development procedure is to evaluate the implementation of the guideline and MOET-instructions in the current care. Therefore measurement of the actual care will be performed in a representative sample of 20 hospitals. This will be done by prospective observation of the third stage of labour of 320 women with a high risk of PPH using quality indicators extracted from the NVOG guideline and MOET instructions. In the next step barriers and facilitators for guideline adherence will be analyzed by performance of semi structured interviews with 30 professionals and 10 patients, followed by a questionnaire study among all Dutch gynaecologists and midwives to quantify the barriers mentioned. Based on the outcomes, a tailored strategy to implement the NVOG guideline and MOET-instructions will be developed and tested in a feasibility study in 4 hospitals, including effect-, process- and cost evaluation. Discussion This study will provide insight into current Dutch practice, in particular to what extent the PPH guidelines of the NVOG and the MOET-instructions have been implemented in the actual care, and into the barriers and facilitators regarding guideline adherence. The knowledge of the feasibility study regarding the effects and costs of the tailored strategy and the experiences of the users can be used in countries with a relatively high incidence of PPH. Trial Registration ClinicTrials.gov NCT00928863 PMID:20102607

  20. Advice for acute low back pain: a comparison of what research supports and what guidelines recommend.

    PubMed

    Stevens, Matthew L; Lin, Chung-Wei C; de Carvalho, Flavia A; Phan, Kevin; Koes, Bart; Maher, Chris G

    2017-10-01

    Advice is widely considered an effective treatment for acute low back pain (LBP); however, details on what and how to deliver this intervention is less clear. We assessed and compared clinical trials that test advice for acute LBP with practice guidelines for their completeness of reporting and concordance on the content, method of delivery, and treatment regimen of advice interventions. Systematic review. Advice randomized controlled trials were identified through a systematic search. Guidelines were taken from recent overviews of guidelines for LBP. Completeness of reporting was assessed using the Template for Intervention Description and Replication checklist. Thematic analysis was used to characterize advice interventions into topics across the aspects of content, method of delivery, and regimen. Concordance between clinical trials and guidelines was assessed by comparing the number of trials that found a statistically significant treatment effect for an intervention that included a specific advice topic with the number of guidelines recommending that topic. The median (interquartile range) completeness of reporting for clinical trials and guidelines was 8 (7-9) and 3 (2-4) out of nine items on the Template for Intervention Description and Replication checklist, respectively. Guideline recommendations were discordant with clinical trials for 50% of the advice topics identified. Completeness of reporting was less than ideal for randomized controlled trials and extremely poor for guidelines. The recommendations made in guidelines of advice for acute LBP were often not concordant with the results of clinical trials. Taken together, these findings mean that the potential clinical value of advice interventions for patients with acute LBP is probably not being realized. Copyright © 2017 Elsevier Inc. All rights reserved.

  1. The CARE guidelines: consensus-based clinical case reporting guideline development

    PubMed Central

    Gagnier, Joel J; Kienle, Gunver; Altman, Douglas G; Moher, David; Sox, Harold; Riley, David

    2013-01-01

    A case report is a narrative that describes, for medical, scientific or educational purposes, a medical problem experienced by one or more patients. Case reports written without guidance from reporting standards are insufficiently rigorous to guide clinical practice or to inform clinical study design. Develop, disseminate and implement systematic reporting guidelines for case reports. We used a three-phase consensus process consisting of (1) premeeting literature review and interviews to generate items for the reporting guidelines, (2) a face-to-face consensus meeting to draft the reporting guidelines and (3) postmeeting feedback, review and pilot testing, followed by finalisation of the case report guidelines. This consensus process involved 27 participants and resulted in a 13-item checklist—a reporting guideline for case reports. The primary items of the checklist are title, key words, abstract, introduction, patient information, clinical findings, timeline, diagnostic assessment, therapeutic interventions, follow-up and outcomes, discussion, patient perspective and informed consent. We believe the implementation of the CARE (CAse REport) guidelines by medical journals will improve the completeness and transparency of published case reports and that the systematic aggregation of information from case reports will inform clinical study design, provide early signals of effectiveness and harms, and improve healthcare delivery. PMID:24155002

  2. Variability in delivered dose and respirable delivered dose from nebulizers: are current regulatory testing guidelines sufficient to produce meaningful information?

    PubMed

    Hatley, Ross Hm; Byrne, Sarah M

    2017-01-01

    To improve convenience to patients, there have been advances in the operation of nebulizers, resulting in fast treatment times and less drug lost to the environment. However, limited attention has been paid to the effects of these developments on the delivered dose (DD) and respirable delivered dose (RDD). Published pharmacopoeia and ISO testing guidelines for adult-use testing utilize a single breathing pattern, which may not be sufficient to enable effective comparisons between the devices. The DD of 5 mg of salbutamol sulfate into adult breathing patterns with inhalation:exhalation (I:E) ratios between 1:1 and 1:4 was determined. Droplet size was determined by laser diffraction and RDD calculated. Nine different nebulizer brands with different modes of operation (conventional, venturi, breath-enhanced, mesh, and breath-activated) were tested. Between the non-breath-activated nebulizers, a 2.5-fold difference in DD (~750-1,900 µg salbutamol) was found; with RDD, there was a more than fourfold difference (~210-980 µg). With increasing time spent on exhalation, there were progressive reductions in DD and RDD, with the RDD at an I:E ratio of 1:4 being as little as 40% of the dose with the 1:1 I:E ratio. The DD and RDD from the breath-activated mesh nebulizer were independent of the I:E ratio, and for the breath-activated jet nebulizer, there was less than 20% change in RDD between the I:E ratios of 1:1 and 1:4. Comparing nebulizers using the I:E ratio recommended in the guidelines does not predict relative performance between the devices at other ratios. There was significant variance in DD or RDD between different brands of non-breath-activated nebulizer. In future, consideration should be given to revision of the test protocols included in the guidelines, to reflect more accurately the potential therapeutic dose that is delivered to a realistic spectrum of breathing patterns.

  3. DEVELOPMENTAL NEUROTOXICITY TESTING GUIDELINES: A QUALIFICATIVE RETROSPECTIVE ANALYSIS OF POSITIVE CONTROL DATA.

    EPA Science Inventory

    The USEPA Developmental Neurotoxicity (DNT) Study Test Guideline calls for both functional and neuropathological assessments in offspring during and following maternal exposure. This guideline also requires data from positive control (PC) agents. Submission of these data permit e...

  4. Challenges with implementing malaria rapid diagnostic tests at primary care facilities in a Ghanaian district: a qualitative study.

    PubMed

    Boadu, Nana Yaa; Amuasi, John; Ansong, Daniel; Einsiedel, Edna; Menon, Devidas; Yanow, Stephanie K

    2016-02-27

    Rapid diagnostic Tests (RDTs) for malaria enable diagnostic testing at primary care facilities in resource-limited settings, where weak infrastructure limits the use of microscopy. In 2010, Ghana adopted a test-before-treat guideline for malaria, with RDT use promoted to facilitate diagnosis. Yet healthcare practitioners still treat febrile patients without testing, or despite negative malaria test results. Few studies have explored RDT implementation beyond the notions of provider or patient acceptability. The aim of this study was to identify the factors directly influencing malaria RDT implementation at primary care facilities in a Ghanaian district. Qualitative interviews, focus groups and direct observations were conducted with 50 providers at six purposively selected primary care facilities in the Atwima-Nwabiagya district. Data were analysed thematically. RDT implementation was hampered by: (1) healthcare delivery constraints (weak supply chain, limited quality assurance and control, inadequate guideline emphasis, staffing limitations); (2) provider perceptions (entrenched case-management paradigms, limited preparedness for change); (3) social dynamics of care delivery (expected norms of provider-patient interaction, test affordability); and (4) limited provider engagement in policy processes leading to fragmented implementation of health sector reform. Limited health system capacity, socio-economic, political, and historical factors hampered malaria RDT implementation at primary care facilities in the study district. For effective RDT implementation providers must be: (1) adequately enabled through efficient allocation and management of essential healthcare commodities; (2) appropriately empowered with the requisite knowledge and skill through ongoing, effective professional development; and (3) actively engaged in policy dialogue to demystify socio-political misconceptions that hinder health sector reform policies from improving care delivery. Clear, consistent guideline emphasis, with complementary action to address deep-rooted provider concerns will build their confidence in, and promote uptake of recommended policies, practices, and technology for diagnosing malaria.

  5. Gram-stain-based antimicrobial selection reduces cost and overuse compared with Japanese guidelines.

    PubMed

    Taniguchi, Tomohiro; Tsuha, Sanefumi; Shiiki, Soichi; Narita, Masashi

    2015-10-26

    The Gram stain has been used as an essential tool for antimicrobial stewardship in our hospital since the 1970s. The objective of this study was to clarify the difference in the targeted therapies selected based on the Gram stain and simulated empirical therapies based on the antimicrobial guidelines used in Japan. A referral-hospital-based prospective descriptive study was undertaken between May 2013 and April 2014 in Okinawa, Japan. All enrolled patients were adults who had been admitted to the Division of Infectious Diseases through the emergency room with suspected bacterial infection at one of three sites: respiratory system, urinary tract, or skin and soft tissues. The study outcomes were the types and effectiveness of the antibiotics initially selected, and their total costs. Two hundred eight patients were enrolled in the study. The median age was 80 years. A significantly narrower spectrum of antibiotics was selected based on the Gram stain than was selected based on the Japanese guidelines. The treatments based on the Gram stain and on the guidelines were estimated to be equally highly effective. The total cost of antimicrobials after Gram-stain testing was less than half the cost after the guidelines were followed. Compared with the Japanese guidelines, the Gram stain dramatically reduced the overuse of broad-spectrum antimicrobials without affecting the effectiveness of the treatment. Drug costs were reduced by half when the Gram stain was used. The Gram stain should be included in all antimicrobial stewardship programs.

  6. Clinician-led improvement in cancer care (CLICC) - testing a multifaceted implementation strategy to increase evidence-based prostate cancer care: phased randomised controlled trial - study protocol

    PubMed Central

    2014-01-01

    Background Clinical practice guidelines have been widely developed and disseminated with the aim of improving healthcare processes and patient outcomes but the uptake of evidence-based practice remains haphazard. There is a need to develop effective implementation methods to achieve large-scale adoption of proven innovations and recommended care. Clinical networks are increasingly being viewed as a vehicle through which evidence-based care can be embedded into healthcare systems using a collegial approach to agree on and implement a range of strategies within hospitals. In Australia, the provision of evidence-based care for men with prostate cancer has been identified as a high priority. Clinical audits have shown that fewer than 10% of patients in New South Wales (NSW) Australia at high risk of recurrence after radical prostatectomy receive guideline recommended radiation treatment following surgery. This trial will test a clinical network-based intervention to improve uptake of guideline recommended care for men with high-risk prostate cancer. Methods/Design In Phase I, a phased randomised cluster trial will test a multifaceted intervention that harnesses the NSW Agency for Clinical Innovation (ACI) Urology Clinical Network to increase evidence-based care for men with high-risk prostate cancer following surgery. The intervention will be introduced in nine NSW hospitals over 10 months using a stepped wedge design. Outcome data (referral to radiation oncology for discussion of adjuvant radiotherapy in line with guideline recommended care or referral to a clinical trial of adjuvant versus salvage radiotherapy) will be collected through review of patient medical records. In Phase II, mixed methods will be used to identify mechanisms of provider and organisational change. Clinicians’ knowledge and attitudes will be assessed through surveys. Process outcome measures will be assessed through document review. Semi-structured interviews will be conducted to elucidate mechanisms of change. Discussion The study will be one of the first randomised controlled trials to test the effectiveness of clinical networks to lead changes in clinical practice in hospitals treating patients with high-risk cancer. It will additionally provide direction regarding implementation strategies that can be effectively employed to encourage widespread adoption of clinical practice guidelines. Trial registration Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12611001251910. PMID:24884877

  7. ASVCP quality assurance guidelines: external quality assessment and comparative testing for reference and in-clinic laboratories.

    PubMed

    Camus, Melinda S; Flatland, Bente; Freeman, Kathleen P; Cruz Cardona, Janice A

    2015-12-01

    The purpose of this document is to educate providers of veterinary laboratory diagnostic testing in any setting about comparative testing. These guidelines will define, explain, and illustrate the importance of a multi-faceted laboratory quality management program which includes comparative testing. The guidelines will provide suggestions for implementation of such testing, including which samples should be tested, frequency of testing, and recommendations for result interpretation. Examples and a list of vendors and manufacturers supplying control materials and services to veterinary laboratories are also included. © 2015 American Society for Veterinary Clinical Pathology.

  8. Confirmatory testing in primary aldosteronism: extensive medication switching is not needed in all patients

    PubMed Central

    Solar, Miroslav; Malirova, Eva; Ballon, Marek; Pelouch, Radek; Ceral, Jiri

    2012-01-01

    Objective Confirmatory testing of suspected primary aldosteronism (PA) requires an extensive medication switch that can be difficult for patients with severe complicated hypertension and/or refractory hypokalemia. For this reason, we investigated the effect of chronic antihypertensive medication on confirmatory testing results. To allow the results to be interpreted, the reproducibility of confirmatory testing was also evaluated. Design and methods The study enrolled 114 individuals with suspected PA who underwent two confirmatory tests. The patients were divided into two groups. In Group A, both tests were performed on the guidelines-recommended therapy, i.e. not interfering with the renin–angiotensin–aldosterone system. In Group B, the first test was performed on chronic therapy with the exclusion of thiazides, loop diuretics, and aldosterone antagonists; and the second test was performed on guidelines-recommended therapy. Saline infusion, preceded by oral sodium loading, was used to suppress aldosterone secretion. Results Agreement in the interpretation of the two confirmatory tests was observed in 84 and 66% of patients in Groups A and B respectively. For all 20 individuals in Group A who ever had end-test serum aldosterone levels ≥240 pmol/l, aldosterone was concordantly nonsuppressible during the other test. Similarly, for all 16 individuals in Group B who had end-test serum aldosterone levels ≥240 pmol/l on modified chronic therapy, aldosterone remained nonsuppressible with guidelines-recommended therapy. Conclusion Confirmatory testing performed while the patient is on chronic therapy without diuretics and aldosterone antagonists can confirm the diagnosis of PA, provided serum aldosterone remains markedly elevated at the end of saline infusion. PMID:22253400

  9. The Concept of Equivalent Radon Concentration for Practical Consideration of Indoor Exposure to Thoron

    PubMed Central

    Chen, Jing; Moir, Deborah

    2012-01-01

    To consider the total exposure to indoor radon and thoron, a concept of equivalent radon concentration for thoron is introduced, defined as the radon concentration that delivers the same annual effective dose as that resulting from the thoron concentration. The total indoor exposure to radon and thoron is then the sum of the radon concentration and the equivalent radon concentration for thoron. The total exposure should be compared to the radon guideline value, and if it exceeds the guideline value, appropriate remedial action is required. With this concept, a separate guideline for indoor thoron exposure is not necessary. For homes already tested for radon with radon detectors, Health Canada’s recommendation of a 3-month radon test performed during the fall/winter heating season not only ensures a conservative estimate of the annual average radon concentration but also covers well any potentially missing contribution from thoron exposure. In addition, because the thoron concentration is much lower than the radon concentration in most homes in Canada, there is no real need to re-test homes for thoron. PMID:22470292

  10. A nationwide survey of pharmacists' perception of pharmacogenetics in the context of a clinical decision support system containing pharmacogenetics dosing recommendations.

    PubMed

    Bank, Paul Cd; Swen, Jesse J; Guchelaar, Henk-Jan

    2017-02-01

    To benchmark Dutch pharmacists knowledge, experience and attitudes toward pharmacogenetics (PGx) with a specific focus on the effects of awareness of the Dutch Pharmacogenetics Working Group guidelines. A web-based survey containing 41 questions was sent to all certified Dutch pharmacists. A total of 667 pharmacists completed the survey (18.8%). Virtually all responders believed in the concept of PGx (99.7%). However, only 14.7% recently ordered a PGx test (≤6 months), 14.1% felt adequately informed and 88.8% would like to receive additional training on PGx. Being aware of the Dutch Pharmacogenetics Working Group guidelines did not have any significant effect on knowledge or adoption of PGx. Dutch pharmacists are very positive toward PGx. However, test adoption is low and additional training is warranted.

  11. Could accreditation bodies facilitate the implementation of medical guidelines in laboratories?

    PubMed

    Aakre, Kristin M; Oosterhuis, Wytze P; Misra, Shivani; Langlois, Michel R; Joseph, Watine; Twomey, Patrick J; Barth, Julian H

    2017-05-01

    Several studies have shown that recommendations related to how laboratory testing should be performed and results interpreted are limited in medical guidelines and that the uptake and implementation of the recommendations that are available need improvement. The EFLM/UEMS Working Group on Guidelines conducted a survey amongst the national societies for clinical chemistry in Europe regarding development of laboratory-related guidelines. The results showed that most countries have guidelines that are specifically related to laboratory testing; however, not all countries have a formal procedure for accepting such guidelines and few countries have guideline committees. Based on this, the EFLM/UEMS Working Group on Guidelines conclude that there is still room for improvement regarding these processes in Europe and raise the question if the accreditation bodies could be a facilitator for an improvement.

  12. The Prestige oil spill: a laboratory study about the toxicity of the water-soluble fraction of the fuel oil.

    PubMed

    Navas, José M; Babín, Mar; Casado, Susana; Fernández, Carlos; Tarazona, José V

    2006-07-01

    The Prestige oil spill caused severe effects on the coastal fauna and flora due to direct contact of organisms with the fuel oil. However, the water soluble fraction (WSF) of the fuel oil can also provoke deleterious effects in the long term and even in regions not directly affected by the spill. Our objective was to determine the toxicity of the WSF using a battery of laboratory toxicity tests. To obtain a WSF in the laboratory, a sample of the spilled fuel was mixed with adequate medium, sonicated, agitated and filtered. No cytotoxic effects were detected in RTG-2 cells exposed to the WSF. In an algae growth inhibition test (OECD test guideline 201) the WSF did not affect the growth of Chlorella vulgaris. Furthermore, acute and reproductive toxicity tests (OECD test guideline 202) carried out using Daphnia magna did not indicate any deleterious effect of the WSF. In a bioassay designed in our laboratory, D. magna were fed with algae previously exposed to the fuel, but no toxic effects were detected. However, the WSF was able to induce a dose-dependent increase of ethoxyresorufin-O-deethylase activity in RTG-2 cells, indicating the presence of chemicals that could cause sub-lethal effects to organisms. After chemical analyses it was established that the final total quantity of polyaromatic hydrocarbons dissolved in medium was approximately 70 ng/ml. These low concentrations explain the observed lack of toxicity.

  13. Synthesis, grading, and presentation of evidence in guidelines: article 7 in Integrating and coordinating efforts in COPD guideline development. An official ATS/ERS workshop report.

    PubMed

    Guyatt, Gordon; Akl, Elie A; Oxman, Andy; Wilson, Kevin; Puhan, Milo A; Wilt, Timothy; Gutterman, David; Woodhead, Mark; Antman, Elliott M; Schünemann, Holger J

    2012-12-01

    Professional societies, like many other organizations around the world, have recognized the need to use more rigorous processes to ensure that health care recommendations are informed by the best available research evidence. This is the seventh of a series of 14 articles that were prepared to advise guideline developers in respiratory and other diseases on approaches for guideline development. This article focuses on synthesizing, rating, and presenting evidence in guidelines. In this review we addressed the following questions. (1) What evidence should guideline panels use to inform their recommendations? (2) How should they rate the quality of the evidence they use? (3) How should they grade evidence regarding diagnostic tests? (4) What should they do when quality of evidence differs across outcomes? (5) How should they present the evidence in a guideline? We did not conduct systematic reviews ourselves. We relied on prior evaluations of electronic databases and systematic reviews suggesting that the Grades of Recommendation, Assessment, Development and Evaluation Working Group (GRADE) approach includes the desired features of a system for grading quality of evidence, including provision of models for presenting evidence for guideline panels, and for the consumers of practice guidelines. This article describes the GRADE approach to grading the quality of evidence and presenting evidence. Available evidence, the practice of leading guideline developers, and workshop discussions provide the basis for our conclusions. GRADE rates the quality of evidence for each outcome across studies rather than for each study. In the GRADE approach randomized trials start as high-quality evidence and observational studies as low-quality evidence, but both can be rated down or up. Five factors may lead to rating down the quality of evidence: study limitations or risk of bias, inconsistency of results, indirectness of evidence, imprecision, and publication bias. Three factors may lead to rating up the quality of evidence from observational studies: large magnitude of effect, dose-response gradient, and situations in which all plausible confounders would decrease an apparent treatment effect, or would create a spurious effect when results suggest no effect. GRADE suggests use of evidence profiles that provide a comprehensive way to display the key evidence relevant to a clinical question. Guideline developers who follow this structure will find the transparency of their recommendations markedly enhanced.

  14. Evaluation of a tailored, multi-component intervention for implementation of evidence-based clinical practice guidelines in primary care physical therapy: a non-randomized controlled trial

    PubMed Central

    2014-01-01

    Background Clinical practice guidelines are important for transmitting research findings into practice and facilitating the application of evidence-based practice (EBP). There is a paucity of knowledge about the impact of guideline implementation strategies in primary care physical therapy. The aim of this study was to evaluate the effect of a guideline implementation intervention in primary care physical therapy in western Sweden. Methods An implementation strategy based on theory and current evidence was developed. A tailored, multi-component implementation intervention, addressing earlier identified determinants, was carried out in three areas comprising 28 physical therapy practices including 277 physical therapists (PTs) (intervention group). In two adjacent areas, 171 PTs at 32 practices received no intervention (control group). The core component of the intervention was an implementation seminar with group discussions. Among other components were a website and email reminders. Data were collected at baseline and follow-up with a web-based questionnaire. Primary outcomes were the self-reported awareness of, knowledge of, access to, and use of guidelines. Secondary outcomes were self-reported attitudes toward EBP and guidelines. Analyses were performed using Pearson’s χ2 test and approximative z-test. Results 168 PTs (60.6%) in the intervention group and 88 PTs (51.5%) in the control group responded to the follow-up questionnaire. 186/277 PTs (67.1%) participated in the implementation seminars, of which 97 (52.2%) responded. The proportions of PTs reporting awareness of (absolute difference in change 20.6%, p = 0.023), knowledge where to find (20.4%, p = 0.007), access to (21.7%, p < 0.001), and frequent use of (9.5%, NS) guidelines increased more in the intervention group than in the control group. The proportion of PTs reporting frequent guideline use after participation in the implementation seminar was 15.2% (p = 0.043) higher than the proportion in the control group. A higher proportion considered EBP helpful in decision making (p = 0.018). There were no other significant differences in secondary outcomes. Conclusions A tailored, theory- and evidence-informed, multi-component intervention for the implementation of clinical practice guidelines had a modest, positive effect on awareness of, knowledge of, access to, and use of guidelines, among PTs in primary care in western Sweden. In general, attitudes to EBP and guidelines were not affected. PMID:24589291

  15. 21 CFR 320.27 - Guidelines on the design of a multiple-dose in vivo bioavailability study.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE BIOAVAILABILITY AND BIOEQUIVALENCE... therapeutic moiety in the body. (2) The test product and the reference material should be administered to...) Measurement of an acute pharmacological effect. When comparison of the test product and the reference material...

  16. 21 CFR 320.27 - Guidelines on the design of a multiple-dose in vivo bioavailability study.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE BIOAVAILABILITY AND BIOEQUIVALENCE... therapeutic moiety in the body. (2) The test product and the reference material should be administered to...) Measurement of an acute pharmacological effect. When comparison of the test product and the reference material...

  17. 21 CFR 320.27 - Guidelines on the design of a multiple-dose in vivo bioavailability study.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE BIOAVAILABILITY AND BIOEQUIVALENCE... therapeutic moiety in the body. (2) The test product and the reference material should be administered to...) Measurement of an acute pharmacological effect. When comparison of the test product and the reference material...

  18. Guidelines on Pilot and Field Testing of Curriculum Products.

    ERIC Educational Resources Information Center

    Contract Research Corp., Belmont, MA.

    This booklet is intended to aid curriculum developers in designing and conducting pilot or field tests that yield useful information and sound evidence about the effectiveness of new curricula. Although it was prepared specifically for use by projects funded by the Curriculum Development Branch of the federal Bureau of Occupational and Adult…

  19. Guidelines for preoperative investigations for elective surgery at Queen Elizabeth Hospital: effects on practices, outcomes, and costs.

    PubMed

    Nicholls, Judith; Gaskin, Pamela S; Ward, Justin; Areti, Yasodananda K

    2016-12-01

    We endeavor to assess the impact of introduction of guidelines for preoperative investigations (PIs) on anesthetic practices and costs and compare their efficacy to current practices. A prospective study. Queen Elizabeth Hospital, Barbados. Participants comprised all patients undergoing general, epidural, spinal, and regional anesthesia, with the exception of emergency cases or instances where an anesthesiologist was not required. Introduction of formal guidelines for preoperative investigations. The patterns of preoperative testing were assessed by audit, and this assessment was repeated postintervention. PI guidelines developed were presented to all surgical departments. For younger patients (<60 years), the mean number of tests decreased from 3.42±1.8 in the preguideline group to 2.89±1.98 in the postguideline group (P=.042). The total number of chest x-rays decreased by 14.8% (P=.012) and full blood counts by 7.6% (P=.036). The implementation of PI guidelines led to overall savings of US $7589 per 1000 patients, which is equivalent to (US $40,745.50 per annum). The most notable savings were due to decreased number of chest x-rays. PIs were performed routinely even in the absence of clinical indications. Our findings indicate that introduction of guidelines has reduced the level of preanesthetic investigations to some extent; nevertheless, further change is desirable. In addition, costs to the institution were decreased with no compromise to patient safety. Copyright © 2016 Elsevier Inc. All rights reserved.

  20. Effects of a real-time exposure to an estrogenic effluent on reproduction in the fathead minnow (Pimephales promelas)

    EPA Science Inventory

    Wastewater treatment plant (WWTP) effluents are a well-established point of convergence through which anthropogenic chemicals enter surface waters. Whole effluent testing guidelines were developed to screen these complex mixtures for acute toxicity. However, effects-based approac...

  1. Catch-up validation study of an in vitro skin irritation test method based on an open source reconstructed epidermis (phase II).

    PubMed

    Groeber, F; Schober, L; Schmid, F F; Traube, A; Kolbus-Hernandez, S; Daton, K; Hoffmann, S; Petersohn, D; Schäfer-Korting, M; Walles, H; Mewes, K R

    2016-10-01

    To replace the Draize skin irritation assay (OECD guideline 404) several test methods based on reconstructed human epidermis (RHE) have been developed and were adopted in the OECD test guideline 439. However, all validated test methods in the guideline are linked to RHE provided by only three companies. Thus, the availability of these test models is dependent on the commercial interest of the producer. To overcome this limitation and thus to increase the accessibility of in vitro skin irritation testing, an open source reconstructed epidermis (OS-REp) was introduced. To demonstrate the capacity of the OS-REp in regulatory risk assessment, a catch-up validation study was performed. The participating laboratories used in-house generated OS-REp to assess the set of 20 reference substances according to the performance standards amending the OECD test guideline 439. Testing was performed under blinded conditions. The within-laboratory reproducibility of 87% and the inter-laboratory reproducibility of 85% prove a high reliability of irritancy testing using the OS-REp protocol. In addition, the prediction capacity was with an accuracy of 80% comparable to previous published RHE based test protocols. Taken together the results indicate that the OS-REp test method can be used as a standalone alternative skin irritation test replacing the OECD test guideline 404. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

  2. Guidelines of the Design of Electropyrotechnic Firing Circuit for Unmanned Flight and Ground Test Projects

    NASA Technical Reports Server (NTRS)

    Gonzalez, Guillermo A.; Lucy, Melvin H.; Massie, Jeffrey J.

    2013-01-01

    The NASA Langley Research Center, Engineering Directorate, Electronic System Branch, is responsible for providing pyrotechnic support capabilities to Langley Research Center unmanned flight and ground test projects. These capabilities include device selection, procurement, testing, problem solving, firing system design, fabrication and testing; ground support equipment design, fabrication and testing; checkout procedures and procedure?s training to pyro technicians. This technical memorandum will serve as a guideline for the design, fabrication and testing of electropyrotechnic firing systems. The guidelines will discuss the entire process beginning with requirements definition and ending with development and execution.

  3. Evidence-based clinical occupational medicine: updating the ACOEM occupational medicine practice guidelines.

    PubMed

    Harris, Jeffrey S; Glass, Lee S; Mueller, Kathryn L; Genovese, Elizabeth

    2004-05-01

    In this article, we review the evolution and application of evidence based medicine and the results of the literature reviews and syntheses incorporated in the second edition of the guidelines. Our intent is to disseminate this information to practitioners treating injured workers and those managing and financing such care and disability management. Use of proven diagnostic, causality, testing,and treatment methods should markedly improve the quality of occupational medical care and make that care more cost effective.

  4. 40 CFR 797.1050 - Algal acute toxicity test.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... seq.). This guideline prescribes test procedures and conditions using freshwater and marine algae to... definitions also apply to this guideline: (1) Algicidal means having the property of killing algae. (2... volumes of nutrient medium and/or test solution. Start the test by introducing algae into the test and...

  5. 40 CFR 797.1050 - Algal acute toxicity test.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... seq.). This guideline prescribes test procedures and conditions using freshwater and marine algae to... definitions also apply to this guideline: (1) Algicidal means having the property of killing algae. (2... volumes of nutrient medium and/or test solution. Start the test by introducing algae into the test and...

  6. 40 CFR 797.1050 - Algal acute toxicity test.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... seq.). This guideline prescribes test procedures and conditions using freshwater and marine algae to... definitions also apply to this guideline: (1) Algicidal means having the property of killing algae. (2... volumes of nutrient medium and/or test solution. Start the test by introducing algae into the test and...

  7. 40 CFR 797.1050 - Algal acute toxicity test.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... seq.). This guideline prescribes test procedures and conditions using freshwater and marine algae to... definitions also apply to this guideline: (1) Algicidal means having the property of killing algae. (2... volumes of nutrient medium and/or test solution. Start the test by introducing algae into the test and...

  8. 40 CFR 797.1050 - Algal acute toxicity test.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... seq.). This guideline prescribes test procedures and conditions using freshwater and marine algae to... definitions also apply to this guideline: (1) Algicidal means having the property of killing algae. (2... volumes of nutrient medium and/or test solution. Start the test by introducing algae into the test and...

  9. Guidelines for the standardization of preanalytic variables for blood-based biomarker studies in Alzheimer’s disease research

    PubMed Central

    Gupta, Veer; Henriksen, Kim; Edwards, Melissa; Jeromin, Andreas; Lista, Simone; Bazenet, Chantal; Soares, Holly; Lovestone, Simon; Hampel, Harald; Montine, Thomas; Blennow, Kaj; Foroud, Tatiana; Carrillo, Maria; Graff-Radford, Neill; Laske, Christoph; Breteler, Monique; Shaw, Leslie; Trojanowski, John Q.; Schupf, Nicole; Rissman, Robert A.; Fagan, Anne M.; Oberoi, Pankaj; Umek, Robert; Weiner, Michael W.; Grammas, Paula; Posner, Holly; Martins, Ralph

    2015-01-01

    The lack of readily available biomarkers is a significant hindrance towards progressing to effective therapeutic and preventative strategies for Alzheimer’s disease (AD). Blood-based biomarkers have potential to overcome access and cost barriers and greatly facilitate advanced neuroimaging and cerebrospinal fluid biomarker approaches. Despite the fact that preanalytical processing is the largest source of variability in laboratory testing, there are no currently available standardized preanalytical guidelines. The current international working group provides the initial starting point for such guidelines for standardized operating procedures (SOPs). It is anticipated that these guidelines will be updated as additional research findings become available. The statement provides (1) a synopsis of selected preanalytical methods utilized in many international AD cohort studies, (2) initial draft guidelines/SOPs for preanalytical methods, and (3) a list of required methodological information and protocols to be made available for publications in the field in order to foster cross-validation across cohorts and laboratories. PMID:25282381

  10. Implementation of a guideline for low back pain management in primary care: a cost-effectiveness analysis.

    PubMed

    Becker, Annette; Held, Heiko; Redaelli, Marcus; Chenot, Jean F; Leonhardt, Corinna; Keller, Stefan; Baum, Erika; Pfingsten, Michael; Hildebrandt, Jan; Basler, Heinz-Dieter; Kochen, Michael M; Donner-Banzhoff, Norbert; Strauch, Konstantin

    2012-04-15

    Cost-effectiveness analysis alongside a cluster randomized controlled trial. To study the cost-effectiveness of 2 low back pain guideline implementation (GI) strategies. Several evidence-based guidelines on management of low back pain have been published. However, there is still no consensus on the effective implementation strategy. Especially studies on the economic impact of different implementation strategies are lacking. This analysis was performed alongside a cluster randomized controlled trial on the effectiveness of 2 GI strategies (physician education alone [GI] or physician education in combination with motivational counseling [MC] by practice nurses)--both compared with the postal dissemination of the guideline (control group, C). Sociodemographic data, pain characteristics, and cost data were collected by interview at baseline and after 6 and 12 months. low back pain-related health care costs were valued for 2004 from the societal perspective. For the cost analysis, 1322 patients from 126 general practices were included. Both interventions showed lower direct and indirect costs as well as better patient outcomes during follow-up compared with controls. In addition, both intervention arms showed superiority of cost-effectiveness to C. The effects attenuated when adjusting for differences of health care utilization prior to patient recruitment and for clustering of data. Trends in cost-effectiveness are visible but need to be confirmed in future studies. Researchers performing cost-evaluation studies should test for baseline imbalances of health care utilization data instead of judging on the randomization success by reviewing non-cost parameters like clinical data alone.

  11. Online training improves paramedics' knowledge of autonomic dysreflexia management guidelines.

    PubMed

    Martin Ginis, K A; Tomasone, J R; Welsford, M; Ethans, K; Sinden, A R; Longeway, M; Krassioukov, A

    2017-02-01

    Single-group pre-/post-test with 3- and 6-month follow-ups. To test the effects of the 'ABCs of AD' educational module on immediate and longer-term changes in paramedics' knowledge and beliefs about using the autonomic dysreflexia clinical practice guidelines (AD-CPGs). Canada. A total of 119 paramedics completed an AD knowledge test and measures of attitudes, perceived control, self-efficacy, social pressure from patients and health-care professionals, and intentions to use the AD-CPGs before and 1 week, 3 months and 6 months after viewing 'ABCs of AD'. There were significant improvements in AD knowledge, attitudes and social pressure from patients to use the AD-CPGs from baseline to 1 week, 3 months and 6 months post viewing (all P<0.001). Self-efficacy and intentions increased 1 week post viewing (P<0.001), but returned to baseline levels at 3 and 6 months (P>0.05). There was no change in perceived control or social pressure from health-care professionals. AD knowledge and beliefs explained 50-61% of the variance in intentions to use the AD-CPGs. Attitudes, social pressure from patients and perceived behavioural control were significant unique predictors of intentions at all time points (P<0.05); AD knowledge was a significant predictor at 6 months only (P=0.048). No other predictors were significant. 'ABCs of AD' has immediate and sustained effects on paramedics' knowledge of attitudes toward and perceived pressure from patients to use the AD-CPGs. Updates to paramedic patient care guidelines and standards are needed to increase paramedics' perceived control and self-efficacy to implement the guidelines, and their intentions to use the AD-CPGs. Canadian Institutes of Health Research (2011-CIHR- 260877).

  12. Evaluation of a Demonstration Program for Postsecondary Hospitality Education.

    ERIC Educational Resources Information Center

    Weis, Susan F.

    A three-phase program evaluation effort employing comparison groups and a pre-post test design indicate formative guidelines for programs revision and summative results indicative of the effectiveness of a demonstration associate degree program for hospitality education. Program effectiveness is defined in terms of the program's enrollment of…

  13. Does social marketing provide a framework for changing healthcare practice?

    PubMed

    Morris, Zoë Slote; Clarkson, Peter John

    2009-07-01

    We argue that social marketing can be used as a generic framework for analysing barriers to the take-up of clinical guidelines, and planning interventions which seek to enable this change. We reviewed the literature on take-up of clinical guidelines, in particular barriers and enablers to change; social marketing principles and social marketing applied to healthcare. We then applied the social marketing framework to analyse the literature and to consider implications for future guideline policy to assess its feasibility and accessibility. There is sizeable extant literature on healthcare practitioners' non-compliance with clinical guidelines. This is an international problem common to a number of settings. The reasons for poor levels of take up appear to be well understood, but not addressed adequately in practice. Applying a social marketing framework brings new insights to the problem." We show that a social marketing framework provides a useful solution-focused framework for systematically understanding barriers to individual behaviour change and designing interventions accordingly. Whether the social marketing framework provides an effective means of bringing about behaviour change remains an empirical question which has still to be tested in practice. The analysis presented here provides strong motivation to begin such testing.

  14. NEPP Update of Independent Single Event Upset Field Programmable Gate Array Testing

    NASA Technical Reports Server (NTRS)

    Berg, Melanie; Label, Kenneth; Campola, Michael; Pellish, Jonathan

    2017-01-01

    This presentation provides a NASA Electronic Parts and Packaging (NEPP) Program update of independent Single Event Upset (SEU) Field Programmable Gate Array (FPGA) testing including FPGA test guidelines, Microsemi RTG4 heavy-ion results, Xilinx Kintex-UltraScale heavy-ion results, Xilinx UltraScale+ single event effect (SEE) test plans, development of a new methodology for characterizing SEU system response, and NEPP involvement with FPGA security and trust.

  15. Test Guideline Methods for Bed Bug Pesticide Products Now Available

    EPA Pesticide Factsheets

    EPA’s final test guidelines, 810.3900 - Laboratory Product Performance Testing Methods for Bed Bug Pesticide Products, provides recommendations for the design and execution of laboratory studies to evaluate the performance of pesticide products.

  16. Proceedings of the Guidelines for Seismometer Testing Workshop, Albuquerque, New Mexico, 9-10 May 2005 ("GST2")

    USGS Publications Warehouse

    Hutt, Charles R.; Nigbor, Robert L.; Evans, John R.

    2009-01-01

    Testing and specification of seismic and earthquake-engineering sensors and recorders has been marked by significant variations in procedures and selected parameters. These variations cause difficulty in comparing such specifications and test results. In July 1989, and again in May 2005, the U.S. Geological Survey hosted international public/private workshops with the goal of defining widely accepted guidelines for the testing of seismological inertial sensors, seismometers, and accelerometers. This document reports the Proceedings of the 2005 workshop and includes as Appendix 6 the report of the 1989 workshop. In a future document, we will attempt to collate and rationalize a single set of formal guidelines for testing and specifying seismic sensors, supplementing Advanced National Seismic System (ANSS) guidelines on instrumentation likely used by ANSS as its standard for verification, acceptance, and intermittent testing, as well as for responses to ANSS instrument requisitions.

  17. Sexual health risks, service use, and views of rapid point-of-care testing among men who have sex with men attending saunas: a cross-sectional survey.

    PubMed

    Horwood, Jeremy; Ingle, Suzanne M; Burton, David; Woodman-Bailey, Adam; Horner, Paddy; Jeal, Nikki

    2016-03-01

    Guidelines highlight the need to increase HIV testing among men who have sex with men (MSM) and novel point-of-care testing provides new possibilities for delivery of care. However, it is unclear how point-of-care testing should be used to best effect. This study aimed to increase understanding of sexual risk-taking behaviour, service use, and attitudes to point-of-care testing among MSM sauna clients. Data were collected within two saunas for MSM in south west England using a self-completion survey (n = 134). Though this sample of MSM sauna clients are at high risk of acquiring a sexually transmitted infection, the testing frequency among the majority of those reporting unprotected anal intercourse is not in keeping with national guidelines. For almost all participants the introduction of rapid point-of-care testing for both genital and blood-borne infection was likely to increase testing and for the majority NHS specialist services was the preferred setting. © The Author(s) 2016.

  18. Sexual health risks, service use, and views of rapid point-of-care testing among men who have sex with men attending saunas: a cross-sectional survey

    PubMed Central

    Horwood, Jeremy; Ingle, Suzanne M; Burton, David; Woodman-Bailey, Adam; Horner, Paddy

    2015-01-01

    Guidelines highlight the need to increase HIV testing among men who have sex with men (MSM) and novel point-of-care testing provides new possibilities for delivery of care. However, it is unclear how point-of-care testing should be used to best effect. This study aimed to increase understanding of sexual risk-taking behaviour, service use, and attitudes to point-of-care testing among MSM sauna clients. Data were collected within two saunas for MSM in south west England using a self-completion survey (n = 134). Though this sample of MSM sauna clients are at high risk of acquiring a sexually transmitted infection, the testing frequency among the majority of those reporting unprotected anal intercourse is not in keeping with national guidelines. For almost all participants the introduction of rapid point-of-care testing for both genital and blood-borne infection was likely to increase testing and for the majority NHS specialist services was the preferred setting. PMID:25907347

  19. Protocol for Atomic Oxygen Testing of Materials in Ground-Based Facilities. No. 2

    NASA Technical Reports Server (NTRS)

    Minton, Timothy K.

    1995-01-01

    A second version of standard guidelines is proposed for improving materials testing in ground-based atomic oxygen environments for the purpose of predicting the durability of the tested materials in low Earth orbit (LEO). Accompanying these guidelines are background information and notes about testing. Both the guidelines and the additional information are intended to aid users who wish to evaluate the potential hazard of atomic oxygen in LEO to a candidate space component without actually flying the component in space, and to provide a framework for more consistent atomic oxygen testing in the future.

  20. Implementing Recommendations From Web Accessibility Guidelines: A Comparative Study of Nondisabled Users and Users With Visual Impairments.

    PubMed

    Schmutz, Sven; Sonderegger, Andreas; Sauer, Juergen

    2017-09-01

    The present study examined whether implementing recommendations of Web accessibility guidelines would have different effects on nondisabled users than on users with visual impairments. The predominant approach for making Web sites accessible for users with disabilities is to apply accessibility guidelines. However, it has been hardly examined whether this approach has side effects for nondisabled users. A comparison of the effects on both user groups would contribute to a better understanding of possible advantages and drawbacks of applying accessibility guidelines. Participants from two matched samples, comprising 55 participants with visual impairments and 55 without impairments, took part in a synchronous remote testing of a Web site. Each participant was randomly assigned to one of three Web sites, which differed in the level of accessibility (very low, low, and high) according to recommendations of the well-established Web Content Accessibility Guidelines 2.0 (WCAG 2.0). Performance (i.e., task completion rate and task completion time) and a range of subjective variables (i.e., perceived usability, positive affect, negative affect, perceived aesthetics, perceived workload, and user experience) were measured. Higher conformance to Web accessibility guidelines resulted in increased performance and more positive user ratings (e.g., perceived usability or aesthetics) for both user groups. There was no interaction between user group and accessibility level. Higher conformance to WCAG 2.0 may result in benefits for nondisabled users and users with visual impairments alike. Practitioners may use the present findings as a basis for deciding on whether and how to implement accessibility best.

  1. Multi-faceted implementation strategy to increase use of a clinical guideline for the diagnosis of deep venous thrombosis in primary care.

    PubMed

    Kingma, Anna E C; van Stel, Henk F; Oudega, Ruud; Moons, Karel G M; Geersing, Geert-Jan

    2017-08-01

    A clinical decision rule (CDR), combined with a negative D-dimer test, can safely rule out deep venous thrombosis (DVT) in primary care. This strategy is recommended by guidelines, yet uptake by GPs is low. To evaluate a multi-faceted implementation strategy aimed at increased use of the guideline recommended CDR plus D-dimer test in primary care patients with suspected DVT. This multi-faceted implementation strategy consisted of educational outreach visits, financial reimbursements and periodical newsletters. 217 Dutch GPs (implementation group) received this strategy and included patients. Effectiveness was measured through the following patient-level outcomes: (i) proportion of non-referred patients, (ii) proportion of missed DVT cases within this group and (iii) the proportion of patients in whom the guideline was applied incorrectly. Implementation outcomes ('acceptability', 'feasibility', 'fidelity' and 'sustainability') were assessed with an online questionnaire. Patient-level outcomes were compared with those of patients included by 450 GPs, uninformed about the study's purposes providing information about usual care. 336 (54%) of 619 analyzable implementation group patients were not referred, missing 6 [1.8% (95% confidence interval 0.7% to 3.9%)] DVT cases. Incorrect guideline use was observed in 199 patients (32%). Self-reported acceptability, feasibility and expected sustainability were high. Guideline use increased from 42% to an expected continuation of use of 91%. Only 32 usual care GPs included 62 patients, making formal comparison unreliable. This multi-faceted implementation strategy safely reduced patient referral to secondary care, despite frequently incorrect application of the guideline and resulted in high acceptability, feasibility and expected sustainability. © The Author 2016. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  2. Regulatory Considerations in Toxicological Neuropathology

    EPA Science Inventory

    Pathological assessment of the nervous system is included in several US Environmental Protection Agency [US EPA or Agency] and Organization for Economic Cooperation and Development [OECD] testing guidelines for health effects of chemicals. A variety of considerations are importan...

  3. Development and evaluation of sediment quality guidelines for Florida coastal waters

    USGS Publications Warehouse

    MacDonald, Donald D.; Carr, R. Scott; Calder, Fred D.; Long, Edward R.; Ingersoll, Christopher G.

    1996-01-01

    The weight-of-evidence approach to the development of sediment quality guidelines (SQGs) was modified to support the derivation of biological effects-based SQGs for Florida coastal waters. Numerical SQGs were derived for 34 substances, including nine trace metals, 13 individual polycyclic aromatic hydrocarbons (PAHs), three groups of PAHs, total polychlorinated biphenyls (PCBs), seven pesticides and one phthalate ester. For each substance, a threshold effects level (TEL) and a probable effects level (PEL) was calculated. These two values defined three ranges of chemical concentrations, including those that were (1) rarely, (2) occasionally or (3) frequently associated with adverse effects. The SQGs were then evaluated to determine their degree of agreement with other guidelines (an indicator of comparability) and the percent incidence of adverse effects within each concentration range (an indicator of reliability). The guidelines also were used to classify (using a dichotomous system: toxic, with one or more exceedances of the PELs or non-toxic, with no exceedances of the TELs) sediment samples collected from various locations in Florida and the Gulf of Mexico. The accuracy of these predictions was then evaluated using the results of the biological tests that were performed on the same sediment samples. The resultant SQGs were demonstrated to provide practical, reliable and predictive tools for assessing sediment quality in Florida and elsewhere in the southeastern portion of the United States.

  4. Guidance on the selection of cohorts for the extended one-generation reproduction toxicity study (OECD test guideline 443).

    PubMed

    Moore, Nigel P; Beekhuijzen, Manon; Boogaard, Peter J; Foreman, Jennifer E; North, Colin M; Palermo, Christine; Schneider, Steffen; Strauss, Volker; van Ravenzwaay, Bennard; Poole, Alan

    2016-10-01

    The extended one-generation reproduction toxicity study (EOGRTS; OECD test guideline 433) is a new and technically complex design to evaluate the putative effects of chemicals on fertility and development, including effects upon the developing nervous and immune systems. In addition to offering a more comprehensive assessment of developmental toxicity, the EOGRTS offers important improvements in animal welfare through reduction and refinement in a modular study design. The challenge to the practitioner is to know how the modular aspects of the study should be triggered on the basis of prior knowledge of a particular chemical, or on earlier findings in the EOGRTS itself, requirements of specific regulatory frameworks notwithstanding. The purpose of this document is to offer guidance on science-based triggers for these extended evaluations. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

  5. Progress Towards the Development of a Fathead Minnow Embryo Test and Comparison to the Zebrafish Embryo Test for Assessing Acute Fish Toxicity

    EPA Science Inventory

    The Zebrafish Embryo Test (ZFET) for acute fish toxicity is a well developed method nearing adoption as an OECD Test Guideline. Early drafts of the test guideline (TG) envisioned a suite of potential test species to be covered including zebrafish, fathead minnow, Japanese Medaka...

  6. Environmental health risk assessment of nickel contamination of drinking water in a country town in NSW.

    PubMed

    Alam, Noore; Corbett, Stephen J; Ptolemy, Helen C

    2008-01-01

    To assess the health risks associated with consumption of drinking water with elevated nickel concentration in a NSW country town named Sampleton. We used enHealth Guidelines (2002) as our risk assessment tool. Laboratory test results for nickel in water samples were compared with the Australian Drinking Water Guidelines 2004 and the World Health Organization's (WHO) Guidelines for Drinking Water Quality 2005. The mean nickel concentration in the drinking water samples tested over a 4-year period (2002-2005) was 0.03 mg/L (95% CI: 0.02-0.04). The average daily consumption of two litres of water by a 70-kg adult provided 0.06 mg (0.03 mg x 2) of nickel, which was only 7% of the lowest observed adverse effect level (LOAEL) based on experiments on nickel-sensitive people in a fasting state. The mean nickel concentration in drinking water appears to have no health risks for the inhabitants of Sampleton.

  7. Designation, diligence and drift: understanding laboratory expenditure increases in British Columbia, 1996/97 to 2005/06.

    PubMed

    Sivananthan, Saskia N; Peterson, Sandra; Lavergne, Ruth; Barer, Morris L; McGrail, Kimberlyn M

    2012-12-21

    Laboratory testing is one of the fastest growing areas of health services spending in Canada. We examine the extent to which increases in laboratory expenditures might be explained by testing that is consistent with guidelines for the management of chronic conditions, by analyzing fee-for-service physician payment data in British Columbia from 1996/97 and 2005/06. We used direct standardization to quantify the effect on laboratory expenditures from changes in: fee levels; population growth; population aging; treatment prevalence; expenditure on recommended tests for those conditions; and expenditure on other tests. The chronic conditions selected were those with guidelines containing laboratory recommendations developed by the BC Guidelines and Protocol Advisory Committee: diabetes, hypertension, congestive heart failure, renal failure, liver disease, rheumatoid arthritis, osteoarthritis and dementia. Laboratory service expenditures increased by $98 million in 2005/06 compared to 1996/97, or 3.6% per year after controlling for population growth and aging. Testing consistent with guideline-recommended care for chronic conditions explained one-third (1.2% per year) of this growth. Changes in treatment prevalence were just as important, contributing 1.5% per year. Hypertension was the most common condition, but renal failure and dementia showed the largest changes in prevalence over time. Changes in other laboratory expenditure including for those without chronic conditions accounted for the remaining 0.9% growth per year. Increases in treatment prevalence were the largest driver of laboratory cost increases between 1996/97 and 2005/06. There are several possible contributors to increasing treatment prevalence, all of which can be expected to continue to put pressure on health care expenditures.

  8. 'As a clinician, you are not managing lab results, you are managing the patient': how the enactment of malaria at health facilities in Cameroon compares with new WHO guidelines for the use of malaria tests.

    PubMed

    Chandler, Clare I R; Mangham, Lindsay; Njei, Abanda Ngu; Achonduh, Olivia; Mbacham, Wilfred F; Wiseman, Virginia

    2012-05-01

    In response to widespread overuse of antimalarial drugs, the World Health Organisation changed guidelines in 2010 to restrict the use of antimalarials to parasitologically confirmed malaria cases. Malaria rapid diagnostic tests (RDTs) have been presented as a means to realize the new guidelines, and National Malaria Control Programmes, including that of Cameroon, are developing plans to introduce the tests to replace microscopy or clinical diagnosis at public health facilities across the country. We aimed to understand how malaria tests and antimalarial drugs are currently used as part of social interactions between health workers and patients at public and mission health facilities in Yaoundé and Bamenda and surrounding districts in the Northwest region of Cameroon. In May to June 2010, we held 17 focus group discussions with 146 health workers involved in clinical care from 49 health facilities. Clinicians enacted malaria as a 'juggling' exercise, involving attention to pathophysiology of the patient as well as their desires and medical reputations, utilising tests and medicines for their therapeutic effects as symbols in the process of care. Parasites were rarely mentioned in describing diagnostic decisions. These enactments of malaria contrast with evidence-based guidelines emanating from WHO, which assume the parasite is the central driver of practice. If RDTs are to be taken up in practice, public health practitioners need to pay careful attention to the values and priorities of health workers and patients if they are to work with them to improve diagnosis and treatment of febrile illnesses. Copyright © 2012 Elsevier Ltd. All rights reserved.

  9. A guideline for heavy ion radiation testing for Single Event Upset (SEU)

    NASA Technical Reports Server (NTRS)

    Nichols, D. K.; Price, W. E.; Malone, C.

    1984-01-01

    A guideline for heavy ion radiation testing for single event upset was prepared to assist new experimenters in preparing and directing tests. How to estimate parts vulnerability and select an irradiation facility is described. A broad brush description of JPL equipment is given, certain necessary pre-test procedures are outlined and the roles and testing guidelines for on-site test personnel are indicated. Detailed descriptions of equipment needed to interface with JPL test crew and equipment are not provided, nor does it meet the more generalized and broader requirements of a MIL-STD document. A detailed equipment description is available upon request, and a MIL-STD document is in the early stages of preparation.

  10. Economic evaluation of HCV testing approaches in low and middle income countries.

    PubMed

    Morgan, Jake R; Servidone, Maria; Easterbrook, Philippa; Linas, Benjamin P

    2017-11-01

    Hepatitis C virus (HCV) infection represents a major public health burden with diverse epidemics worldwide, but at present, only a minority of infected persons have been tested and are aware of their diagnosis. The advent of highly effective direct acting antiviral (DAA) therapy, which is becoming available at increasingly lower costs in low and middle income countries (LMICs), represents a major opportunity to expand access to testing and treatment. However, there is uncertainty as to the optimal testing approaches and who to prioritize for testing. We undertook a narrative review of the cost-effectiveness literature on different testing approaches for chronic hepatitis C infection to inform decision-making and formulation of recommendations in the 2017 World Health Organization (WHO) viral hepatitis testing guidelines. We undertook a focused search and narrative review of the literature for cost effectiveness studies of testing approaches in three main groups:- 1) focused testing of specific high-risk groups (defined as those who are part of a population with higher seroprevalence or who have a history of exposure or high-risk behaviours); 2) "birth cohort" testing among easily identified age groups (i.e. specific birth cohorts) known to have a high prevalence of HCV infection; and 3) routine testing in the general population. Articles included were those published in PubMed, written in English and published after 2000. We identified 26 eligible studies. Twenty-four of them were from Europe (n = 14) or the United States (n = 10). There was only one study from a LMIC (Egypt) and this evaluated general population testing. Thirteen studies evaluated focused testing among specific groups at high risk for HCV infection, including nine in persons who inject drugs (PWID); five among people in prison, and one among HIV-infected men who have sex with men (MSM). Eight studies evaluated birth cohort testing, and five evaluated testing in the general population. Most studies were based on a one-time testing intervention, but in one study testing was undertaken every 5 years and in another among HIV-infected MSM there was more frequent testing. Comparators were generally either: 1) no testing, 2) the status quo, or 3) multiple different strategies. Overall, we found broad agreement that focused testing of high risk groups such as persons who inject drugs and men who have sex with men was cost-effective, as was birth cohort testing. Key drivers of cost-effectiveness were the prevalence of HCV infection in these groups, efficacy and cost of treatment, stage of disease and linkage to care. The evidence for routine population testing was mixed, and the cost-effectiveness depends largely on the prevalence of HCV. The evidence base for different HCV testing approaches in LMICs is limited, minimizing the contribution of cost-effectiveness data alone to decision-making and recommendations on testing approaches in the 2017 WHO viral hepatitis testing guidelines. Overall, the guidelines recommended focused testing in high risk-groups, particularly PWID, prisoners, and men who have sex with men; with consideration of two other approaches:- birth cohort testing in those countries with epidemiological evidence of a significant birth cohort effect; and routine access to testing across the general population in those countries with a high HCV seroprevalence above 2% - 5% in the general population. Further implementation research on different testing approaches is needed in order to help guide national policy planning.

  11. Revisiting sweat chloride test results based on recent guidelines for diagnosis of cystic fibrosis.

    PubMed

    Pagaduan, Jayson V; Ali, Mahesheema; Dowlin, Michael; Suo, Liye; Ward, Tabitha; Ruiz, Fadel; Devaraj, Sridevi

    2018-03-01

    Recent sweat chloride guidelines published by the Cystic Fibrosis Foundation changed the intermediate sweat chloride concentration range from 40-59 mmol/L to 30-59 mmol/L for age > 6 months. We wanted to know how this new guideline would impact detection of cystic fibrosis among patients who previously had sweat tests done at Texas Children's Hospital. We revisited sweat chloride test results (n = 3012) in the last 5 years at Texas Children's Hospital based on the new guidelines on diagnosis of cystic fibrosis from the Cystic Fibrosis Foundation. We identified 125 patients that would be reclassified in the intermediate sweat chloride value with the new guidelines that were classified as "unlikely to have CF" in the previous guidelines. 8 (32%) patients with CFTR gene testing were positive for CFTR gene mutation(s). 4 (50%) of these patients were identified to have 2 CFTR mutations. One had variant combination that was reported to cause CF but all were diagnosed with CFTR-related metabolic syndrome. Our findings concur with the new CF diagnosis guidelines that changing the intermediate cut-off to 30-59 mmol/L sweat chloride concentration in combination with CFTR genetic analysis enhances the probability of identifying individuals that have risk of developing CF or have CF and enables for earlier therapeutic intervention.

  12. How to report a research study.

    PubMed

    Cronin, Paul; Rawson, James V; Heilbrun, Marta E; Lee, Janie M; Kelly, Aine M; Sanelli, Pina C; Bresnahan, Brian W; Paladin, Angelisa M

    2014-09-01

    Incomplete reporting hampers the evaluation of results and bias in clinical research studies. Guidelines for reporting study design and methods have been developed to encourage authors and journals to include the required elements. Recent efforts have been made to standardize the reporting of clinical health research including clinical guidelines. In this article, the reporting of diagnostic test accuracy studies, screening studies, therapeutic studies, systematic reviews and meta-analyses, cost-effectiveness assessments (CEA), recommendations and/or guidelines, and medical education studies is discussed. The available guidelines, many of which can be found at the Enhancing the QUAlity and Transparency Of health Research network, on how to report these different types of health research are also discussed. We also hope that this article can be used in academic programs to educate the faculty and trainees of the available resources to improve our health research. Copyright © 2014 AUR. Published by Elsevier Inc. All rights reserved.

  13. Pre-implementation guidelines for infectious disease point-of-care testing in medical institutions.

    PubMed

    van der Eijk, Annemiek A; Tintu, Andrei N; Hays, John P

    2017-01-01

    Infectious disease point-of-care test (ID-POCT) devices are becoming widely available, and in this respect, international quality standards and guidelines are available for consultation once ID-POCT has been implemented into medical institutions. However, specific guidelines for consultation during the initial pre-implementation decision-making process are currently lacking. Further, there exist pre-implementation issues specific to ID-POCT. Here we present pre-implementation guidelines for consultation when considering the implementation of ID-POCT in medical institutions.

  14. A randomized matched-pairs study of feasibility, acceptability, and effectiveness of systems consultation: a novel implementation strategy for adopting clinical guidelines for Opioid prescribing in primary care.

    PubMed

    Quanbeck, Andrew; Brown, Randall T; Zgierska, Aleksandra E; Jacobson, Nora; Robinson, James M; Johnson, Roberta A; Deyo, Brienna M; Madden, Lynn; Tuan, Wen-Jan; Alagoz, Esra

    2018-01-25

    This paper reports on the feasibility, acceptability, and effectiveness of an innovative implementation strategy named "systems consultation" aimed at improving adherence to clinical guidelines for opioid prescribing in primary care. While clinical guidelines for opioid prescribing have been developed, they have not been widely implemented, even as opioid abuse reaches epidemic levels. We tested a blended implementation strategy consisting of several discrete implementation strategies, including audit and feedback, academic detailing, and external facilitation. The study compares four intervention clinics to four control clinics in a randomized matched-pairs design. Each systems consultant aided clinics on implementing the guidelines during a 6-month intervention consisting of monthly site visits and teleconferences/videoconferences. The mixed-methods evaluation employs the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework. Quantitative outcomes are compared using time series analysis. Qualitative methods included focus groups, structured interviews, and ethnographic field techniques. Seven clinics were randomly approached to recruit four intervention clinics. Each clinic designated a project team consisting of six to eight staff members, each with at least one prescriber. Attendance at intervention meetings was 83%. More than 80% of staff respondents agreed or strongly agreed with the statements: "I am more familiar with guidelines for safe opioid prescribing" and "My clinic's workflow for opioid prescribing is easier." At 6 months, statistically significant improvements were noted in intervention clinics in the percentage of patients with mental health screens, treatment agreements, urine drug tests, and opioid-benzodiazepine co-prescribing. At 12 months, morphine-equivalent daily dose was significantly reduced in intervention clinics compared to controls. The cost to deliver the strategy was $7345 per clinic. Adaptations were required to make the strategy more acceptable for primary care. Qualitatively, intervention clinics reported that chronic pain was now treated using approaches similar to those employed for other chronic conditions, such as hypertension and diabetes. The systems consultation implementation strategy demonstrated feasibility, acceptability, and effectiveness in a study involving eight primary care clinics. This multi-disciplinary strategy holds potential to mitigate the prevalence of opioid addiction and ultimately may help to improve implementation of clinical guidelines across healthcare. ClinicalTrials.gov (NCT02433496). https://clinicaltrials.gov/ct2/show/NCT02433496 Registered May 5, 2015.

  15. A Novel Approach to Improving Utilization of Laboratory Testing.

    PubMed

    Zhou, Yaolin; Procop, Gary W; Riley, Jacquelyn D

    2018-02-01

    - The incorporation of best practice guidelines into one's institution is a challenging goal of utilization management, and the successful adoption of such guidelines depends on institutional context. Laboratorians who have access to key clinical data are well positioned to understand existing local practices and promote more appropriate laboratory testing. - To apply a novel approach to utilization management by reviewing international clinical guidelines and current institutional practices to create a reliable mechanism to improve detection and reduce unnecessary tests in our patient population. - We targeted a frequently ordered genetic test for HFE-related hereditary hemochromatosis, a disorder of low penetrance. After reviewing international practice guidelines, we evaluated 918 HFE tests and found that all patients with new diagnoses had transferrin saturation levels that were significantly higher than those of patients with nonrisk genotypes (72% versus 42%; P < .001). - Our "one-button" order that restricts HFE genetic tests to patients with transferrin saturation greater than 45% is consistent with published practice guidelines and detected 100% of new patients with HFE-related hereditary hemochromatosis. - Our proposed algorithm differs from previously published approaches in that it incorporates both clinical practice guidelines and local physician practices, yet requires no additional hands-on effort from pathologists or clinicians. This novel approach to utilization management embraces the role of pathologists as leaders in promoting high-quality patient care in local health care systems.

  16. Quality in genetic counselling for presymptomatic testing--clinical guidelines for practice across the range of genetic conditions.

    PubMed

    Skirton, Heather; Goldsmith, Lesley; Jackson, Leigh; Tibben, Aad

    2013-03-01

    Presymptomatic testing (PST) is the performance of a genetic test on an asymptomatic individual at risk of a condition to determine whether the person has inherited the disease-causing mutation. Although relevant guidelines exist for specific diseases, there is no overarching protocol that can be adapted to any disorder or clinical setting in which such testing is offered. The objective of this European project was to develop a set of coherent guidelines for PST (for adult-onset monogenic conditions) for use by health professionals working in a range of disciplines, countries or contexts. To ensure the guidelines were appropriate and practice based, we organised a workshop attended by an expert group of practitioners with relevant health professional backgrounds from 11 countries. Models of service for offering PST were presented, the group then discussed different aspects of testing and the standard of care required to ensure that patients were prepared to make decisions and deal with results and consequences. After the workshop, several rounds of consultation were used with a wider group of professionals to refine the guidelines. The guidelines include general principles governing the offer of testing (eg, autonomous choice of the patient), objectives of genetic counselling in this context (eg, facilitation of decision making), logistical considerations (eg, use of trained staff) and topics to be included during counselling discussion with the patient (eg, consequences of both positive and negative outcomes). We recommend the adoption of these guidelines to provide an equitable structure for those seeking PST in any country.

  17. Best practice guidelines for the molecular genetic diagnosis of Type 1 (HFE-related) hereditary haemochromatosis

    PubMed Central

    King, Caitriona; Barton, David E

    2006-01-01

    Background Hereditary haemochromatosis (HH) is a recessively-inherited disorder of iron over-absorption prevalent in Caucasian populations. Affected individuals for Type 1 HH are usually either homozygous for a cysteine to tyrosine amino acid substitution at position 282 (C282Y) of the HFE gene, or compound heterozygotes for C282Y and for a histidine to aspartic acid change at position 63 (H63D). Molecular genetic testing for these two mutations has become widespread in recent years. With diverse testing methods and reporting practices in use, there was a clear need for agreed guidelines for haemochromatosis genetic testing. The UK Clinical Molecular Genetics Society has elaborated a consensus process for the development of disease-specific best practice guidelines for genetic testing. Methods A survey of current practice in the molecular diagnosis of haemochromatosis was conducted. Based on the results of this survey, draft guidelines were prepared using the template developed by UK Clinical Molecular Genetics Society. A workshop was held to develop the draft into a consensus document. The consensus document was then posted on the Clinical Molecular Genetics Society website for broader consultation and amendment. Results Consensus or near-consensus was achieved on all points in the draft guidelines. The consensus and consultation processes worked well, and outstanding issues were documented in an appendix to the guidelines. Conclusion An agreed set of best practice guidelines were developed for diagnostic, predictive and carrier testing for hereditary haemochromatosis and for reporting the results of such testing. PMID:17134494

  18. 78 FR 59946 - Current List of Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum...

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  19. 76 FR 161 - Current List of Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum...

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    2011-01-03

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  20. 77 FR 54597 - Current List of Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum...

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    2012-09-05

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  1. 76 FR 24501 - Current List of Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum...

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    2011-05-02

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  2. 77 FR 20832 - Current List of Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum...

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    2012-04-06

    ... Engage in Urine Drug Testing for Federal Agencies AGENCY: Substance Abuse and Mental Health Services... the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory... ``Mandatory Guidelines for Federal Workplace Drug Testing Programs,'' as amended in the revisions listed above...

  3. 77 FR 45645 - Current List of Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum...

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    2012-08-01

    ... Engage in Urine Drug Testing for Federal Agencies AGENCY: Substance Abuse and Mental Health Services... the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory... 100-71. The ``Mandatory Guidelines for Federal Workplace Drug Testing Programs,'' as amended in the...

  4. 76 FR 68201 - Current List of Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum...

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    2011-11-03

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  5. 78 FR 72684 - Current List of Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum...

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    2013-12-03

    ... Engage in Urine Drug Testing for Federal Agencies AGENCY: Substance Abuse and Mental Health Services... the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory... 503 of Publicc Law 100-71. The ``Mandatory Guidelines for Federal Workplace Drug Testing Programs...

  6. 76 FR 31969 - Current List of Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-02

    ... Engage in Urine Drug Testing for Federal Agencies AGENCY: Substance Abuse and Mental Health Services... the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory... ``Mandatory Guidelines for Federal Workplace Drug Testing Programs'', as amended in the revisions listed above...

  7. 78 FR 314 - Current List of Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum...

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    2013-01-03

    ... Engage in Urine Drug Testing for Federal Agencies AGENCY: Substance Abuse and Mental Health Services... the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory... ``Mandatory Guidelines for Federal Workplace Drug Testing Programs'', as amended in the revisions listed above...

  8. 75 FR 67749 - Current List of Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-03

    ... Engage in Urine Drug Testing for Federal Agencies AGENCY: Substance Abuse and Mental Health Services... the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory... 100-71. The ``Mandatory Guidelines for Federal Workplace Drug Testing Programs,'' as amended in the...

  9. 78 FR 14100 - Current List of Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-04

    ... Engage in Urine Drug Testing for Federal Agencies AGENCY: Substance Abuse and Mental Health Services... the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory... ``Mandatory Guidelines for Federal Workplace Drug Testing Programs'', as amended in the revisions listed above...

  10. 77 FR 69642 - Current List of Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-20

    ... Engage in Urine Drug Testing for Federal Agencies AGENCY: Substance Abuse and Mental Health Services... the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory... ``Mandatory Guidelines for Federal Workplace Drug Testing Programs'', as amended in the revisions listed above...

  11. 78 FR 66034 - Current List of Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-04

    ... Engage in Urine Drug Testing For Federal Agencies AGENCY: Substance Abuse and Mental Health Services... the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory... 503 of Public Law 100-71. The ``Mandatory Guidelines for Federal Workplace Drug Testing Programs,'' as...

  12. 77 FR 5037 - Current List of Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-01

    ... Engage in Urine Drug Testing for Federal Agencies AGENCY: Substance Abuse and Mental Health Services... the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory... ``Mandatory Guidelines for Federal Workplace Drug Testing Programs'', as amended in the revisions listed above...

  13. 76 FR 75889 - Current List of Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-05

    ... Engage in Urine Drug Testing for Federal Agencies AGENCY: Substance Abuse and Mental Health Services... the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory... ``Mandatory Guidelines for Federal Workplace Drug Testing Programs'', as amended in the revisions listed above...

  14. 77 FR 60449 - Current List of Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-03

    ... Engage in Urine Drug Testing for Federal Agencies AGENCY: Substance Abuse and Mental Health Services... the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory... ``Mandatory Guidelines for Federal Workplace Drug Testing Programs'', as amended in the revisions listed above...

  15. 77 FR 26022 - Current List of Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-02

    ... Engage in Urine Drug Testing for Federal Agencies AGENCY: Substance Abuse and Mental Health Services... the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory... ``Mandatory Guidelines for Federal Workplace Drug Testing Programs'', as amended in the revisions listed above...

  16. 76 FR 61110 - Current List of Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-03

    ... Engage in Urine Drug Testing for Federal Agencies AGENCY: Substance Abuse and Mental Health Services... the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory... ``Mandatory Guidelines for Federal Workplace Drug Testing Programs,'' as amended in the revisions listed above...

  17. 77 FR 32653 - Current List of Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-01

    ... Engage in Urine Drug Testing for Federal Agencies AGENCY: Substance Abuse and Mental Health Services... the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory... 100-71. The ``Mandatory Guidelines for Federal Workplace Drug Testing Programs'', as amended in the...

  18. 78 FR 54903 - Current List of Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-06

    ... Engage in Urine Drug Testing for Federal Agencies AGENCY: Substance Abuse and Mental Health Services... the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory... 503 of Public Law 100-71. The ``Mandatory Guidelines for Federal Workplace Drug Testing Programs,'' as...

  19. 76 FR 18770 - Current List of Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-05

    ... Engage in Urine Drug Testing for Federal Agencies AGENCY: Substance Abuse and Mental Health Services... the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory... ``Mandatory Guidelines for Federal Workplace Drug Testing Programs,'' as amended in the revisions listed above...

  20. 76 FR 40924 - Current List of Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-12

    ... Engage in Urine Drug Testing for Federal Agencies AGENCY: Substance Abuse and Mental Health Services... the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory... ``Mandatory Guidelines for Federal Workplace Drug Testing Programs'', as amended in the revisions listed above...

  1. 76 FR 54477 - Current List of Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-01

    ... Engage in Urine Drug Testing for Federal Agencies AGENCY: Substance Abuse and Mental Health Services... the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory... ``Mandatory Guidelines for Federal Workplace Drug Testing Programs'', as amended in the revisions listed above...

  2. 78 FR 19500 - Current List of Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum...

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    2013-04-01

    ... Engage in Urine Drug Testing for Federal Agencies AGENCY: Substance Abuse and Mental Health Services... the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory... ``Mandatory Guidelines for Federal Workplace Drug Testing Programs'', as amended in the revisions listed above...

  3. 76 FR 46309 - Current List of Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-02

    ... Engage in Urine Drug Testing for Federal Agencies AGENCY: Substance Abuse and Mental Health Services... the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory... ``Mandatory Guidelines for Federal Workplace Drug Testing Programs'', as amended in the revisions listed above...

  4. 76 FR 6147 - Current List of Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-03

    ... Engage in Urine Drug Testing for Federal Agencies AGENCY: Substance Abuse and Mental Health Services... the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory... ``Mandatory Guidelines for Federal Workplace Drug Testing Programs'', as amended in the revisions listed above...

  5. 76 FR 11802 - Current List of Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-03

    ... Engage in Urine Drug Testing for Federal Agencies AGENCY: Substance Abuse and Mental Health Services... the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory... ``Mandatory Guidelines for Federal Workplace Drug Testing Programs'', as amended in the revisions listed above...

  6. 77 FR 71605 - Current List of Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-03

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  7. 77 FR 39501 - Current List of Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-03

    ... Engage in Urine Drug Testing for Federal Agencies AGENCY: Substance Abuse and Mental Health Services... the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory... ``Mandatory Guidelines for Federal Workplace Drug Testing Programs'', as amended in the revisions listed above...

  8. 78 FR 33429 - Current List of Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum...

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    2013-06-04

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  9. 78 FR 25461 - Current List of Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum...

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    2013-05-01

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  10. 77 FR 12862 - Current List of Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum...

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    2012-03-02

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  11. 78 FR 7795 - Current List of Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum...

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    2013-02-04

    ... Engage in Urine Drug Testing for Federal Agencies AGENCY: Substance Abuse and Mental Health Services... the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory... Public Law 100-71. The ``Mandatory Guidelines for Federal Workplace Drug Testing Programs'', as amended...

  12. Assessing healthcare quality using routine data: evaluating the performance of the national tuberculosis programme in South Africa.

    PubMed

    McLaren, Zoë M; Sharp, Alana R; Zhou, Jifang; Wasserman, Sean; Nanoo, Ananta

    2017-02-01

    To assess the performance of healthcare facilities by means of indicators based on guidelines for clinical care of TB, which is likely a good measure of overall facility quality. We assessed quality of care in all public health facilities in South Africa using graphical, correlation and locally weighted kernel regression analysis of routine TB test data. Facility performance falls short of national standards of care. Only 74% of patients with TB provided a second specimen for testing, 18% received follow-up testing and 14% received drug resistance testing. Only resistance testing rates improved over time, tripling between 2004 and 2011. National awareness campaigns and changes in clinical guidelines had only a transient impact on testing rates. The poorest performing facilities remained at the bottom of the rankings over the period of study. The optimal policy strategy requires both broad-based policies and targeted resources to poor performers. This approach to assessing facility quality of care can be adapted to other contexts and also provides a low-cost method for evaluating the effectiveness of proposed interventions. Devising targeted policies based on routine data is a cost-effective way to improve the quality of public health care provided. © 2016 John Wiley & Sons Ltd.

  13. How can we get close to zero? The potential contribution of biomedical prevention and the investment framework towards an effective response to HIV.

    PubMed

    Stover, John; Hallett, Timothy B; Wu, Zunyou; Warren, Mitchell; Gopalappa, Chaitra; Pretorius, Carel; Ghys, Peter D; Montaner, Julio; Schwartländer, Bernhard

    2014-01-01

    In 2011 an Investment Framework was proposed that described how the scale-up of key HIV interventions could dramatically reduce new HIV infections and deaths in low and middle income countries by 2015. This framework included ambitious coverage goals for prevention and treatment services resulting in a reduction of new HIV infections by more than half. However, it also estimated a leveling in the number of new infections at about 1 million annually after 2015. We modeled how the response to AIDS can be further expanded by scaling up antiretroviral treatment (ART) within the framework provided by the 2013 WHO treatment guidelines. We further explored the potential contributions of new prevention technologies: 'Test and Treat', pre-exposure prophylaxis and an HIV vaccine. Immediate aggressive scale up of existing approaches including the 2013 WHO guidelines could reduce new infections by 80%. A 'Test and Treat' approach could further reduce new infections. This could be further enhanced by a future highly effective pre-exposure prophylaxis and an HIV vaccine, so that a combination of all four approaches could reduce new infections to as low as 80,000 per year by 2050 and annual AIDS deaths to 260,000. In a set of ambitious scenarios, we find that immediate implementation of the 2013 WHO antiretroviral therapy guidelines could reduce new HIV infections by 80%. Further reductions may be achieved by moving to a 'Test and Treat' approach, and eventually by adding a highly effective pre-exposure prophylaxis and an HIV vaccine, if they become available.

  14. Measuring continuous baseline covariate imbalances in clinical trial data

    PubMed Central

    Ciolino, Jody D.; Martin, Renee’ H.; Zhao, Wenle; Hill, Michael D.; Jauch, Edward C.; Palesch, Yuko Y.

    2014-01-01

    This paper presents and compares several methods of measuring continuous baseline covariate imbalance in clinical trial data. Simulations illustrate that though the t-test is an inappropriate method of assessing continuous baseline covariate imbalance, the test statistic itself is a robust measure in capturing imbalance in continuous covariate distributions. Guidelines to assess effects of imbalance on bias, type I error rate, and power for hypothesis test for treatment effect on continuous outcomes are presented, and the benefit of covariate-adjusted analysis (ANCOVA) is also illustrated. PMID:21865270

  15. Guidelines for the Gamification of Self-Management of Chronic Illnesses: Multimethod Study

    PubMed Central

    Wills, Gary; Ranchhod, Ashok

    2017-01-01

    Background Gamification is the use of game elements and techniques in nongaming contexts. The use of gamification in health care is receiving a great deal of attention in both academic research and the industry. However, it can be noticed that many gamification apps in health care do not follow any standardized guidelines. Objective This research aims to (1) present a set of guidelines based on the validated framework the Wheel of Sukr and (2) assess the guidelines through expert interviews and focus group sessions with developers. Methods Expert interviews (N=6) were conducted to assess the content of the guidelines and that they reflect the Wheel of Sukr. In addition, the guidelines were assessed by developers (N=15) in 5 focus group sessions, where each group had an average of 3 developers. Results The guidelines received support from the experts. By the end of the sixth interview, it was determined that a saturation point was reached. Experts agreed that the guidelines accurately reflect the framework the Wheel of Sukr and that developers can potentially use them to create gamified self-management apps for chronic illnesses. Moreover, the guidelines were welcomed by developers who participated in the focus group sessions. They found the guidelines to be clear, useful, and implementable. Also, they were able to suggest many ways of gamifying a nongamified self-management app when they were presented with one. Conclusions The findings suggest that the guidelines introduced in this research are clear, useful, and ready to be implemented for the creation of self-management apps that use the notion of gamification as described in the Wheel of Sukr framework. The guidelines are now ready to be practically tested. Further practical studies of the effectiveness of each element in the guidelines are to be carried out. PMID:28500018

  16. Rapid implementation of evidence-based guidelines for imaging after first urinary tract infection.

    PubMed

    Jerardi, Karen E; Elkeeb, Dena; Weiser, Jason; Brinkman, William B

    2013-09-01

    The American Academy of Pediatrics published a new guideline for management of first urinary tract infection (UTI) in children aged 2 to 24 months in September 2011. The imaging evaluation changed from the previous guideline to recommend voiding cystourethrogram (VCUG) only for patients with an abnormal renal and bladder ultrasound (RBUS). The objective was to decrease the proportion of guideline-eligible children with a normal RBUS who underwent VCUG from median of 92% for patients treated as inpatients and 100% for patients treated in the emergency department to 5% in both settings. This was a quality improvement implementation study in a large academic medical center. Key drivers included: appropriate guideline knowledge, timely identification of guideline eligible patients, and effective communication with the community-based primary care provider. A multidisciplinary team developed and tested interventions. Impact was assessed with annotated run charts. Statistical comparisons were made with χ(2) analysis and Fisher's exact test. The proportion of children with first UTI and normal RBUS who underwent VCUG decreased from a median of 92% to 0% within 1 month of initiating the project among those hospitalized and from 100% to 40% within 4 months among those diagnosed in the emergency department. Rates have been sustained for 12 months and 8 months, respectively. Interventions using the electronic medical record and ordering system were most impactful. Rapid adoption of evidence-based UTI care across multiple settings is achievable. Practice change occurred faster and to a greater magnitude in the inpatient setting compared with the outpatient setting.

  17. Rapid Implementation of Evidence-Based Guidelines for Imaging After First Urinary Tract Infection

    PubMed Central

    Elkeeb, Dena; Weiser, Jason; Brinkman, William B.

    2013-01-01

    BACKGROUND AND OBJECTIVES: The American Academy of Pediatrics published a new guideline for management of first urinary tract infection (UTI) in children aged 2 to 24 months in September 2011. The imaging evaluation changed from the previous guideline to recommend voiding cystourethrogram (VCUG) only for patients with an abnormal renal and bladder ultrasound (RBUS). The objective was to decrease the proportion of guideline-eligible children with a normal RBUS who underwent VCUG from median of 92% for patients treated as inpatients and 100% for patients treated in the emergency department to 5% in both settings. METHODS: This was a quality improvement implementation study in a large academic medical center. Key drivers included: appropriate guideline knowledge, timely identification of guideline eligible patients, and effective communication with the community-based primary care provider. A multidisciplinary team developed and tested interventions. Impact was assessed with annotated run charts. Statistical comparisons were made with χ2 analysis and Fisher’s exact test. RESULTS: The proportion of children with first UTI and normal RBUS who underwent VCUG decreased from a median of 92% to 0% within 1 month of initiating the project among those hospitalized and from 100% to 40% within 4 months among those diagnosed in the emergency department. Rates have been sustained for 12 months and 8 months, respectively. Interventions using the electronic medical record and ordering system were most impactful. CONCLUSIONS: Rapid adoption of evidence-based UTI care across multiple settings is achievable. Practice change occurred faster and to a greater magnitude in the inpatient setting compared with the outpatient setting. PMID:23958774

  18. A Review of the Centers for Disease Control and Prevention's Guidelines for the Clinical Laboratory Diagnosis of Lyme Disease.

    PubMed

    Miraglia, Caterina M

    2016-12-01

    The purpose of this paper is to review information regarding the current guidelines for the clinical laboratory diagnosis of Lyme disease as set forth by the Centers for Disease Control and Prevention (CDC) to chiropractic physicians and to discuss the clinical utility of this testing. The CDC's website was reviewed to determine what their current recommendations are for the clinical laboratory testing of Lyme disease. The CDC's established guidelines recommend the use of a 2-tiered serologic testing algorithm for the evaluation of patients with suspected Lyme disease. This review provides doctors of chiropractic with information to remain current with the CDC's recommended guidelines for Lyme disease testing because patients may present to their office with the associated signs and symptoms of Lyme disease.

  19. Secondary Prevention of Cervical Cancer: ASCO Resource-Stratified Clinical Practice Guideline.

    PubMed

    Jeronimo, Jose; Castle, Philip E; Temin, Sarah; Denny, Lynette; Gupta, Vandana; Kim, Jane J; Luciani, Silvana; Murokora, Daniel; Ngoma, Twalib; Qiao, Youlin; Quinn, Michael; Sankaranarayanan, Rengaswamy; Sasieni, Peter; Schmeler, Kathleen M; Shastri, Surendra S

    2017-10-01

    To provide resource-stratified, evidence-based recommendations on the secondary prevention of cervical cancer globally. ASCO convened a multidisciplinary, multinational panel of oncology, primary care, epidemiology, health economic, cancer control, public health, and patient advocacy experts to produce recommendations reflecting four resource-tiered settings. A review of existing guidelines, a formal consensus-based process, and a modified ADAPTE process to adapt existing guidelines were conducted. Other experts participated in formal consensus. Seven existing guidelines were identified and reviewed, and adapted recommendations form the evidence base. Four systematic reviews plus cost-effectiveness analyses provided indirect evidence to inform consensus, which resulted in ≥ 75% agreement. Human papillomavirus (HPV) DNA testing is recommended in all resource settings; visual inspection with acetic acid may be used in basic settings. Recommended age ranges and frequencies by setting are as follows: maximal: ages 25 to 65, every 5 years; enhanced: ages 30 to 65, if two consecutive negative tests at 5-year intervals, then every 10 years; limited: ages 30 to 49, every 10 years; and basic: ages 30 to 49, one to three times per lifetime. For basic settings, visual assessment is recommended as triage; in other settings, genotyping and/or cytology are recommended. For basic settings, treatment is recommended if abnormal triage results are present; in other settings, colposcopy is recommended for abnormal triage results. For basic settings, treatment options are cryotherapy or loop electrosurgical excision procedure; for other settings, loop electrosurgical excision procedure (or ablation) is recommended. Twelve-month post-treatment follow-up is recommended in all settings. Women who are HIV positive should be screened with HPV testing after diagnosis and screened twice as many times per lifetime as the general population. Screening is recommended at 6 weeks postpartum in basic settings; in other settings, screening is recommended at 6 months. In basic settings without mass screening, infrastructure for HPV testing, diagnosis, and treatment should be developed.Additional information can be found at www.asco.org/rs-cervical-cancer-secondary-prev-guideline and www.asco.org/guidelineswiki.It is the view of of ASCO that health care providers and health care system decision makers should be guided by the recommendations for the highest stratum of resources available. The guideline is intended to complement, but not replace, local guidelines.

  20. Secondary Prevention of Cervical Cancer: ASCO Resource-Stratified Clinical Practice Guideline

    PubMed Central

    Jeronimo, Jose; Castle, Philip E.; Temin, Sarah; Denny, Lynette; Gupta, Vandana; Kim, Jane J.; Luciani, Silvana; Murokora, Daniel; Ngoma, Twalib; Qiao, Youlin; Quinn, Michael; Sankaranarayanan, Rengaswamy; Sasieni, Peter; Schmeler, Kathleen M.; Shastri, Surendra S.

    2017-01-01

    Purpose To provide resource-stratified, evidence-based recommendations on the secondary prevention of cervical cancer globally. Methods ASCO convened a multidisciplinary, multinational panel of oncology, primary care, epidemiology, health economic, cancer control, public health, and patient advocacy experts to produce recommendations reflecting four resource-tiered settings. A review of existing guidelines, a formal consensus-based process, and a modified ADAPTE process to adapt existing guidelines were conducted. Other experts participated in formal consensus. Results Seven existing guidelines were identified and reviewed, and adapted recommendations form the evidence base. Four systematic reviews plus cost-effectiveness analyses provided indirect evidence to inform consensus, which resulted in ≥ 75% agreement. Recommendations Human papillomavirus (HPV) DNA testing is recommended in all resource settings; visual inspection with acetic acid may be used in basic settings. Recommended age ranges and frequencies by setting are as follows: maximal: ages 25 to 65, every 5 years; enhanced: ages 30 to 65, if two consecutive negative tests at 5-year intervals, then every 10 years; limited: ages 30 to 49, every 10 years; and basic: ages 30 to 49, one to three times per lifetime. For basic settings, visual assessment is recommended as triage; in other settings, genotyping and/or cytology are recommended. For basic settings, treatment is recommended if abnormal triage results are present; in other settings, colposcopy is recommended for abnormal triage results. For basic settings, treatment options are cryotherapy or loop electrosurgical excision procedure; for other settings, loop electrosurgical excision procedure (or ablation) is recommended. Twelve-month post-treatment follow-up is recommended in all settings. Women who are HIV positive should be screened with HPV testing after diagnosis and screened twice as many times per lifetime as the general population. Screening is recommended at 6 weeks postpartum in basic settings; in other settings, screening is recommended at 6 months. In basic settings without mass screening, infrastructure for HPV testing, diagnosis, and treatment should be developed. Additional information can be found at www.asco.org/rs-cervical-cancer-secondary-prev-guideline and www.asco.org/guidelineswiki. It is the view of of ASCO that health care providers and health care system decision makers should be guided by the recommendations for the highest stratum of resources available. The guideline is intended to complement, but not replace, local guidelines. PMID:29094101

  1. Revision of the ICH guideline on detection of toxicity to reproduction for medicinal products: SWOT analysis.

    PubMed

    Barrow, Paul

    2016-09-01

    SWOT analysis was used to gain insights and perspectives into the revision of the ICH S5(R2) guideline on detection of toxicity to reproduction for medicinal products. The current ICH guideline was rapidly adopted worldwide and has an excellent safety record for more than 20 years. The revised guideline should aim to further improve reproductive and developmental (DART) safety testing for new drugs. Alternative methods to animal experiments should be used whenever possible. Modern technology should be used to obtain high quality data from fewer animals. Additions to the guideline should include considerations on the following: limit dose setting, maternal toxicity, biopharmaceuticals, vaccines, testing strategies by indication, developmental immunotoxicity, and male-mediated developmental toxicity. Emerging issues, such as epigenetics and the microbiome, will most likely pose challenges to DART testing in the future. It is hoped that the new guideline will be adopted even outside the ICH regions. Copyright © 2016 Elsevier Inc. All rights reserved.

  2. Systematic review of colorectal cancer screening guidelines for average-risk adults: Summarizing the current global recommendations.

    PubMed

    Bénard, Florence; Barkun, Alan N; Martel, Myriam; von Renteln, Daniel

    2018-01-07

    To summarize and compare worldwide colorectal cancer (CRC) screening recommendations in order to identify similarities and disparities. A systematic literature search was performed using MEDLINE, EMBASE, Scopus, CENTRAL and ISI Web of knowledge identifying all average-risk CRC screening guideline publications within the last ten years and/or position statements published in the last 2 years. In addition, a hand-search of the webpages of National Gastroenterology Society websites, the National Guideline Clearinghouse, the BMJ Clinical Evidence website, Google and Google Scholar was performed. Fifteen guidelines were identified. Six guidelines were published in North America, four in Europe, four in Asia and one from the World Gastroenterology Organization. The majority of guidelines recommend screening average-risk individuals between ages 50 and 75 using colonoscopy (every 10 years), or flexible sigmoidoscopy (FS, every 5 years) or fecal occult blood test (FOBT, mainly the Fecal Immunochemical Test, annually or biennially). Disparities throughout the different guidelines are found relating to the use of colonoscopy, rank order between test, screening intervals and optimal age ranges for screening. Average risk individuals between 50 and 75 years should undergo CRC screening. Recommendations for optimal surveillance intervals, preferred tests/test cascade as well as the optimal timing when to start and stop screening differ regionally and should be considered for clinical decision making. Furthermore, local resource availability and patient preferences are important to increase CRC screening uptake, as any screening is better than none.

  3. Taking Ownership of the ITC's Guidelines for Computer-Based and Internet-Delivered Testing: A South African Application

    ERIC Educational Resources Information Center

    Foxcroft, Cheryl D.; Davies, Caroline

    2006-01-01

    The increased use of computer-based and Internet-delivered testing has raised a number of ethical and legal issues. The International Test Commission's (this issue) Guidelines for Computer-Based and Internet-Delivered Testing represent the most recent attempt to provide test users, publishers, and developers with guidance regarding the appropriate…

  4. Measure Guideline: Combustion Safety for Natural Draft Appliances Through Appliance Zone Isolation

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

    Fitzgerald, J.; Bohac, D.

    2014-04-01

    This measure guideline covers how to assess and carry out the isolation of natural draft combustion appliances from the conditioned space of low-rise residential buildings. It deals with combustion appliances located either within the living space in enclosed closets or side rooms or outside the living space in an adjacent area like an attic or garage. This subset of houses does not require comprehensive combustion safety tests and simplified prescriptive procedures can be used to address safety concerns. This allows residential energy retrofit contractors inexperienced in advanced combustion safety testing to effectively address combustion safety issues and allow energy retrofitsmore » including tightening and changes to distribution and ventilation systems to proceed.« less

  5. Effects of multiple life stage exposure to the fungicide prochloraz in Xenopus laevis: Manifestations of antiandrogenic and other modes of toxicity

    EPA Science Inventory

    The Larval Amphibian Growth and Development Assay (LAGDA) is an internationally harmonized testing guideline for evaluating effects of chronic chemical exposure in amphibians. To evaluate the utility of the assay design during the development phase antiandrogen prochloraz was te...

  6. Framework for Building an Effective Student Assessment System: READ/SABER Working Paper

    ERIC Educational Resources Information Center

    Clarke, Marguerite

    2011-01-01

    The purpose of this paper is to help countries understand some of the "key principles and characteristics of an effective student assessment system". The focus is on assessment of student learning and achievement at the K-12 level. The paper extracts principles and guidelines from countries' experiences, professional testing standards,…

  7. Potential toxic effects of aircraft de-icers and wastewater samples containing these compounds.

    PubMed

    Mohiley, A; Franzaring, J; Calvo, O C; Fangmeier, A

    2015-09-01

    One of the major problems of airport operation is the impact of pollution caused by runoff waters. Runoff waters at an airport may contain high concentrations of different contaminants resulting from various activities of its operation. High quantities of aircraft de-icing/anti-icing fluids are used annually at airports worldwide. Aircraft de-icers and anti-icers may have negative environmental impacts, but their effects on aquatic organisms are virtually unknown. In order to address this issue, aircraft de-icers, pavement de-icers and wastewater samples were obtained from a regional airport. To evaluate the toxicity of wastewater samples and aircraft de-icing/anti-icing fluids (ADAFs), two bio-tests were performed: the Lemna growth inhibition test according to OECD guideline 221 and the luminescent bacteria test according to ISO guideline 11348-2. In the Lemna growth inhibition test, phytotoxicity was assessed using the endpoints frond number and frond area. The luminescent bacteria test involved the marine bacterium Vibrio fischeri. The estimates of effective concentrations (EC50) values were determined using the free software R and the "drc" library. Aquatic plants and marine bacteria showed a higher sensitivity towards ADAFs than to wastewater samples. Experiments showed that aircraft de-icing/anti-icing fluids and wastewater samples were relatively more toxic towards Lemna gibba L. in comparison to V. fischeri.

  8. 75 FR 16813 - Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-02

    ... Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal... Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the... of [[Page 16814

  9. Development and validation of an international appraisal instrument for assessing the quality of clinical practice guidelines: the AGREE project.

    PubMed

    2003-02-01

    International interest in clinical practice guidelines has never been greater but many published guidelines do not meet the basic quality requirements. There have been renewed calls for validated criteria to assess the quality of guidelines. To develop and validate an international instrument for assessing the quality of the process and reporting of clinical practice guideline development. The instrument was developed through a multi-staged process of item generation, selection and scaling, field testing, and refinement procedures. 100 guidelines selected from 11 participating countries were evaluated independently by 194 appraisers with the instrument. Following refinement the instrument was further field tested on three guidelines per country by a new set of 70 appraisers. The final version of the instrument contained 23 items grouped into six quality domains with a 4 point Likert scale to score each item (scope and purpose, stakeholder involvement, rigour of development, clarity and presentation, applicability, editorial independence). 95% of appraisers found the instrument useful for assessing guidelines. Reliability was acceptable for most domains (Cronbach's alpha 0.64-0.88). Guidelines produced as part of an established guideline programme had significantly higher scores on editorial independence and, after the publication of a national policy, had significantly higher quality scores on rigour of development (p<0.005). Guidelines with technical documentation had higher scores on that domain (p<0.0001). This is the first time an appraisal instrument for clinical practice guidelines has been developed and tested internationally. The instrument is sensitive to differences in important aspects of guidelines and can be used consistently and easily by a wide range of professionals from different backgrounds. The adoption of common standards should improve the consistency and quality of the reporting of guideline development worldwide and provide a framework to encourage international comparison of clinical practice guidelines.

  10. Implementation of the integrated management of childhood illness with parasitological diagnosis of malaria in rural Ghana: health worker perceptions.

    PubMed

    Febir, Lawrence G; Baiden, Frank E; Agula, Justina; Delimini, Rupert K; Akpalu, Bright; Tivura, Mathilda; Amanfo, Nelson; Chandramohan, Daniel; Owusu-Agyei, Seth; Webster, Jayne

    2015-04-23

    Timely and appropriate management of febrile illness among children under five years of age will contribute to achieving Millennium Development Goal-4. The revised World Health Organization-Global Malaria Programme's policy on test-based management of malaria must integrate effectively into the Integrated Management of Childhood Illness (IMCI). This study reports on perceptions of health workers on the health system factors influencing effective delivery of test-based diagnosis of malaria with IMCI. A qualitative study was conducted among a range of health workers at different levels of the health system in the Brong Ahafo Region of Ghana. Interview transcripts were transferred into Nvivo 8 software for data management and analysis. A frame-work approach at two levels was used in the analysis, which included the processes required for implementation of test-based management of malaria and the health systems context. Forty-nine in-depth interviews were conducted. The National Health Insurance Scheme (NHIS) was perceived to have led to an increase in health facility attendance, thereby increasing the workload of health workers. Workload was reported as the main reason that health workers were not able to complete all of the examinations included in the IMCI algorithm. The NHIS financing guidelines were seen to be determining diagnosis and treatment practices by health-care givers. Concern was expressed about the erratic supply of malaria rapid diagnostic test kits (RDTs), the quality of RDTs related to potential false negative results when clinical symptoms were consistent with malaria. IMCI was seen as important but practically impossible to fully implement due to workload. Implementation of the WHO-revised IMCI guideline is confronted with a myriad of health systems challenges. The perceptions of front-line health workers on the accuracy and need for RDTs together with the capacity of health systems to support implementation plays a crucial role. The NHIS financing guidelines of diagnostics and treatments are influencing clinical decision-making in this setting. Further study is needed to understand the impact of the NHIS on the feasibility of integrating test-based management for malaria into the IMCI guidelines.

  11. Effect of the 2013 AHA/ASA guidelines on TPA use in acute ischemic stroke at Assaf Harofeh Medical Center in Israel.

    PubMed

    Kimiagar, Itzhak; Kalmanovich-Avnery, Shani; Gonen, Ofer M; Sacagiu, Zvika; Shevtzov, Evelina; Levite, Ronen; Weinstein, Jochay; Bartal, Avigail; Aroesty, Rina; Bhonkar, Sarah; Tal, Sigal; Leonov, Youval; Blatt, Alex; Haitov, Zoya; Bar-Hayim, Samuel; Armon, Carmel

    2016-10-15

    Use of TPA to treat patients with acute ischemic stroke was introduced in Assaf Harofeh Medical Center (AHMC) in Israel in November 2007 initially with strict adherence to the inclusion/exclusion criteria of the pivotal NINDS TPA studies published in 1995. The treatment window was expanded in 2010 to 4.5h following the results of ECASS-III. Application of the 2013 AHA/ASA Guidelines resulted in further expanded inclusion and relaxed exclusion criteria. A retrospective chart review was conducted of patients who received TPA at AHMC to evaluate the additional impact of applying the 2013 guidelines. Number of patients treated, outcomes at discharge, and safety were compared between two periods: May 2011-January 2013 (the 21months preceding the 2013 Guidelines); and February 2013-October 2014 (the 21months after publication of the 2013 Guidelines). Statistical analysis was done using z-tests for differences between proportions, and t-tests to compare means. 63 patients were treated during the immediate pre-2013 Guideline period (36/year, or approximately 5% of patients with ischemic stroke), and 105 during the post-2013 Guidelines period (60/year, approximately 8.3% of patients with ischemic stroke) (p<0.001). During the two periods, respectively: discharges home were 22(34%) and 55(52%) (p<0.05); facility discharges were 29(46%) and 33(31%); and inter-hospital transfers were 6(9%), and 11(10% of treated patients). Most transfers were for endovascular treatment. Total treatment-related symptomatic bleeds in the two periods, respectively, was: 4(6%) and 4(4%), and the number of in-hospital deaths was 6 (9%) and 6 (6%) (unchanged). Application of the 2013 AHA/ASA Guidelines resulted in a 64% increase in the number of acute ischemic stroke patients treated with TPA at AHMC with no worsening of aggregate outcomes and no increase in bleeds or deaths. Copyright © 2016 Elsevier B.V. All rights reserved.

  12. Adoption of the 2015 World Health Organization guidelines on antiretroviral therapy: Programmatic implications for India.

    PubMed

    Rewari, Bharat Bhushan; Agarwal, Reshu; Shastri, Suresh; Nagaraja, Sharath Burugina; Rathore, Abhilakh Singh

    2017-04-01

    The therapeutic and preventive benefits of early initiation of antiretroviral therapy (ART) for HIV are now well established. Reflecting new research evidence, in 2015 the World Health Organization (WHO) recommended initiation of ART for all people living with HIV (PLHIV), irrespective of their clinical staging and CD4 cell count. The National AIDS Control Programme (NACP) in India is currently following the 2010 WHO ART guidelines for adults and the 2013 guidelines for pregnant women and children. This desk study assessed the number of people living with HIV who will additionally be eligible for ART on adoption of the 2015 WHO recommendations on ART. Data routinely recorded for all PLHIV registered under the NACP up to 31 December 2015 were analysed. Of the 250 865 individuals recorded in pre-ART care, an estimated 135 593 would be eligible under the WHO 2013 guidelines. A further 100 221 would be eligible under the WHO 2015 guidelines. Initiating treatment for all PLHIV in pre-ART care would raise the number on ART from 0.92 million to 1.17 million. In addition, nearly 0.07 million newly registered PLHIV will become eligible every year if the WHO 2015 guidelines are adopted, of which 0.028 million would be attributable to implementation of the WHO 2013 guidelines alone. In addition to drugs, there will be a need for additional CD4 tests and tests of viral load, as the numbers on ART will increase significantly. The outlay should be seen in the context of potential health-care savings due to early initiation of ART, in terms of the effect on disease progression, complications, deaths and new infections. While desirable, adoption of the new guidance will have significant programmatic and resource implications for India. The programme needs to plan and strengthen the service-delivery mechanism, with emphasis on newer and innovative approaches before implementation of these guidelines.

  13. Perioperative cardiopulmonary exercise testing (CPET): consensus clinical guidelines on indications, organization, conduct, and physiological interpretation.

    PubMed

    Levett, D Z H; Jack, S; Swart, M; Carlisle, J; Wilson, J; Snowden, C; Riley, M; Danjoux, G; Ward, S A; Older, P; Grocott, M P W

    2018-03-01

    The use of perioperative cardiopulmonary exercise testing (CPET) to evaluate the risk of adverse perioperative events and inform the perioperative management of patients undergoing surgery has increased over the last decade. CPET provides an objective assessment of exercise capacity preoperatively and identifies the causes of exercise limitation. This information may be used to assist clinicians and patients in decisions about the most appropriate surgical and non-surgical management during the perioperative period. Information gained from CPET can be used to estimate the likelihood of perioperative morbidity and mortality, to inform the processes of multidisciplinary collaborative decision making and consent, to triage patients for perioperative care (ward vs critical care), to direct preoperative interventions and optimization, to identify new comorbidities, to evaluate the effects of neoadjuvant cancer therapies, to guide prehabilitation and rehabilitation, and to guide intraoperative anaesthetic practice. With the rapid uptake of CPET, standardization is key to ensure valid, reproducible results that can inform clinical decision making. Recently, an international Perioperative Exercise Testing and Training Society has been established (POETTS www.poetts.co.uk) promoting the highest standards of care for patients undergoing exercise testing, training, or both in the perioperative setting. These clinical cardiopulmonary exercise testing guidelines have been developed by consensus by the Perioperative Exercise Testing and Training Society after systematic literature review. The guidelines have been endorsed by the Association of Respiratory Technology and Physiology (ARTP). Copyright © 2017. Published by Elsevier Ltd.

  14. Receipt of Glucose Testing and Performance of Two US Diabetes Screening Guidelines, 2007–2012

    PubMed Central

    Bullard, Kai McKeever; Ali, Mohammed K.; Imperatore, Giuseppina; Geiss, Linda S.; Saydah, Sharon H.; Albu, Jeanine B.; Cowie, Catherine C.; Sohler, Nancy; Albright, Ann; Gregg, Edward W.

    2015-01-01

    Background Screening guidelines are used to help identify prediabetes and diabetes before implementing evidence-based prevention and treatment interventions. We examined screening practices benchmarking against two US guidelines, and the capacity of each guideline to identify dysglycemia. Methods Using 2007–2012 National Health and Nutrition Examination Surveys, we analyzed nationally-representative, cross-sectional data from 5,813 fasting non-pregnant adults aged ≥20 years without self-reported diabetes. We examined proportions of adults eligible for diagnostic glucose testing and those who self-reported receiving testing in the past three years, as recommended by the American Diabetes Association (ADA) and the US Preventive Services Task Force (USPSTF-2008) guidelines. For each screening guideline, we also assessed sensitivity, specificity, and positive (PPV) and negative predictive values in identifying dysglycemia (defined as fasting plasma glucose ≥100 mg/dl or hemoglobin A1c ≥5.7%). Results In 2007–2012, 73.0% and 23.7% of US adults without diagnosed diabetes met ADA and USPSTF-2008 criteria for screening, respectively; and 91.5% had at least one major risk factor for diabetes. Of those ADA- or USPSTF-eligible adults, about 51% reported being tested within the past three years. Eligible individuals not tested were more likely to be lower educated, poorer, uninsured, or have no usual place of care compared to tested eligible adults. Among adults with ≥1 major risk factor, 45.7% reported being tested, and dysglycemia yields (i.e., PPV) ranged from 45.8% (high-risk ethnicity) to 72.6% (self-reported prediabetes). ADA criteria and having any risk factor were more sensitive than the USPSTF-2008 guideline (88.8–97.7% vs. 31.0%) but less specific (13.5–39.7% vs. 82.1%) in recommending glucose testing, resulting in lower PPVs (47.7–54.4% vs. 58.4%). Conclusion Diverging recommendations and variable performance of different guidelines may be impeding national diabetes prevention and treatment efforts. Efforts to align screening recommendations may result in earlier identification of adults at high risk for prediabetes and diabetes. PMID:25928306

  15. Prescriber Compliance With Liver Monitoring Guidelines for Pazopanib in the Postapproval Setting: Results From a Distributed Research Network.

    PubMed

    Shantakumar, Sumitra; Nordstrom, Beth L; Hall, Susan A; Djousse, Luc; van Herk-Sukel, Myrthe P P; Fraeman, Kathy H; Gagnon, David R; Chagin, Karen; Nelson, Jeanenne J

    2017-04-20

    Pazopanib received US Food and Drug Administration approval in 2009 for advanced renal cell carcinoma. During clinical development, liver chemistry abnormalities and adverse hepatic events were observed, leading to a boxed warning for hepatotoxicity and detailed label prescriber guidelines for liver monitoring. As part of postapproval regulatory commitments, a cohort study was conducted to assess prescriber compliance with liver monitoring guidelines. Over a 4-year period, a distributed network approach was used across 3 databases: US Veterans Affairs Healthcare System, a US outpatient oncology community practice database, and the Dutch PHARMO Database Network. Measures of prescriber compliance were designed using the original pazopanib label guidelines for liver monitoring. Results from the VA (n = 288) and oncology databases (n = 283) indicate that prescriber liver chemistry monitoring was less than 100%: 73% to 74% compliance with baseline testing and 37% to 39% compliance with testing every 4 weeks. Compliance was highest near drug initiation and decreased over time. Among patients who should have had weekly testing, the compliance was 56% in both databases. The more serious elevations examined, including combinations of liver enzyme elevations meeting the laboratory definition of Hy's law were infrequent but always led to appropriate discontinuation of pazopanib. Only 4 patients were identified for analysis in the Dutch database; none had recorded baseline testing. In this population-based study, prescriber compliance was reasonable near pazopanib initiation but low during subsequent weeks of treatment. This study provides information from real-world community practice settings and offers feedback to regulators on the effectiveness of label monitoring guidelines.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

  16. 77 FR 126 - Current List of Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-03

    ... Engage in Urine Drug Testing for Federal Agencies AGENCY: Substance Abuse and Mental Health Services... certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs... ``Mandatory Guidelines for Federal Workplace Drug Testing Programs'', as amended in the revisions listed above...

  17. 75 FR 39023 - Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-07

    ... Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal... Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the... of Laboratories Engaged in Urine Drug Testing for Federal Agencies,'' sets strict standards that...

  18. 75 FR 27348 - Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-14

    ... Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal... Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the... of Laboratories Engaged in Urine Drug Testing for Federal Agencies,'' sets strict standards that...

  19. 75 FR 9229 - Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-01

    ... Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal... Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the... of Laboratories Engaged in Urine Drug Testing for Federal Agencies,'' sets strict standards that...

  20. 75 FR 5088 - Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-01

    ... Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal... Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the... of Laboratories Engaged in Urine Drug Testing for Federal Agencies,'' sets strict standards that...

  1. 75 FR 154 - Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-04

    ... Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal... Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the... of Laboratories Engaged in Urine Drug Testing for Federal Agencies,'' sets strict standards that...

  2. 75 FR 45128 - Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-02

    ... Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal... Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the..., ``Certification of Laboratories Engaged in Urine Drug Testing for Federal Agencies,'' sets strict standards that...

  3. 75 FR 32950 - Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-10

    ... Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal... Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the... of Laboratories Engaged in Urine Drug Testing for Federal Agencies,'' sets strict standards that...

  4. 75 FR 55795 - Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-14

    ... Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal... Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the... of Laboratories Engaged in Urine Drug Testing for Federal Agencies,'' sets strict standards that...

  5. Cost-effective management of women with minor cervical lesions: Revisiting the application of HPV DNA testing.

    PubMed

    Pedersen, Kine; Burger, Emily A; Sy, Stephen; Kristiansen, Ivar S; Kim, Jane J

    2016-11-01

    Lack of consensus in management guidelines for women with minor cervical lesions, coupled with novel screening approaches, such as human papillomavirus (HPV) genotyping, necessitate revisiting prevention policies. We evaluated the cost-effectiveness and resource trade-offs of alternative triage strategies to inform cervical cancer prevention in Norway. We used a decision-analytic model to compare the lifetime health and economic consequences associated with ten novel candidate approaches to triage women with minor cervical lesions. Candidate strategies varied by: 1) the triage test(s): HPV testing in combination with cytology, HPV testing alone with or without genotyping for HPV-16 and -18, and immediate colposcopy, and 2) the length of time between index and triage testing (i.e., 6, 12 or 18months). Model outcomes included quality-adjusted life-years (QALYs), lifetime societal costs, and resource use (e.g., colposcopy referrals). The current Norwegian guidelines were less effective and more costly than candidate strategies. Given a commonly-cited willingness-to-pay threshold in Norway of $100,000 per QALY gained, the preferred strategy involved HPV genotyping with immediate colposcopy referral for HPV-16 or -18 positive and repeat HPV testing at 12months for non-HPV-16 or -18 positive ($78,010 per QALY gained). Differences in health benefits among candidate strategies were small, while resource use varied substantially. More effective strategies required a moderate increase in colposcopy referrals (e.g., a 9% increase for the preferred strategy) compared with current levels. New applications of HPV testing may improve management of women with minor cervical lesions, yet are accompanied by a trade-off of increased follow-up procedures. Copyright © 2016 Elsevier Inc. All rights reserved.

  6. Cost-effective management of women with minor cervical lesions: Revisiting the application of HPV DNA testing

    PubMed Central

    Pedersen, Kine; Burger, Emily A.; Sy, Stephen; Kristiansen, Ivar S.; Kim, Jane J.

    2016-01-01

    Background Lack of consensus in management guidelines for women with minor cervical lesions, coupled with novel screening approaches, such as human papillomavirus (HPV) genotyping, necessitate revisiting prevention policies. We evaluated the cost-effectiveness and resource trade-offs of alternative triage strategies to inform cervical cancer prevention in Norway. Methods We used a decision-analytic model to compare the lifetime health and economic consequences associated with ten novel candidate approaches to triage women with minor cervical lesions. Candidate strategies varied by: 1) the triage test(s): HPV testing in combination with cytology, HPV testing alone with or without genotyping for HPV-16 and-18, and immediate colposcopy, and 2) the length of time between index and triage testing (i.e., 6, 12 or 18 months). Model outcomes included quality-adjusted life-years (QALYs), lifetime societal costs, and resource use (e.g., colposcopy referrals). Results The current Norwegian guidelines were less effective and more costly than candidate strategies. Given a commonly-cited willingness-to-pay threshold in Norway of $100,000 per QALY gained, the preferred strategy involved HPV genotyping with immediate colposcopy referral for HPV-16 or -18 positive and repeat HPV testing at 12 months for non-HPV-16 or -18 positive ($78,010 per QALY gained). Differences in health benefits among candidate strategies were small, while resource use varied substantially. More effective strategies required a moderate increase in colposcopy referrals (e.g., a 9% increase for the preferred strategy) compared with current levels. Conclusion New applications of HPV testing may improve management for women with minor cervical lesions, yet are accompanied by a trade-off of increased follow-up procedures. PMID:27542966

  7. The CARE guidelines: consensus-based clinical case report guideline development.

    PubMed

    Gagnier, Joel J; Kienle, Gunver; Altman, Douglas G; Moher, David; Sox, Harold; Riley, David

    2014-01-01

    A case report is a narrative that describes, for medical, scientific, or educational purposes, a medical problem experienced by one or more patients. Case reports written without guidance from reporting standards are insufficiently rigorous to guide clinical practice or to inform clinical study design. Develop, disseminate, and implement systematic reporting guidelines for case reports. We used a three-phase consensus process consisting of (1) pre-meeting literature review and interviews to generate items for the reporting guidelines, (2) a face-to-face consensus meeting to draft the reporting guidelines, and (3) post-meeting feedback, review, and pilot testing, followed by finalization of the case report guidelines. This consensus process involved 27 participants and resulted in a 13-item checklist-a reporting guideline for case reports. The primary items of the checklist are title, key words, abstract, introduction, patient information, clinical findings, timeline, diagnostic assessment, therapeutic interventions, follow-up and outcomes, discussion, patient perspective, and informed consent. We believe the implementation of the CARE (CAse REport) guidelines by medical journals will improve the completeness and transparency of published case reports and that the systematic aggregation of information from case reports will inform clinical study design, provide early signals of effectiveness and harms, and improve healthcare delivery. Copyright © 2014 Reproduced with permission of Global Advances in Health and Medicine. Published by Elsevier Inc. All rights reserved.

  8. Revision of OECD Guidelines for Genotoxicity Testing: Current Status and Next Steps

    EPA Science Inventory

    Over the past 30 years, assays have been developed to evaluate chemical genotoxicity. OECD Genotoxicity Test Guidelines (TG) describe assay procedures for regulatory safety testing. Since the last OECD TG revision (1997), there has been tremendous scientific and technological pro...

  9. Do the Guideline Violations Influence Test Difficulty of High-Stake Test?: An Investigation on University Entrance Examination in Turkey

    ERIC Educational Resources Information Center

    Atalmis, Erkan Hasan

    2016-01-01

    Multiple-choice (MC) items are commonly used in high-stake tests. Thus, each item of such tests should be meticulously constructed to increase the accuracy of decisions based on test results. Haladyna and his colleagues (2002) addressed the valid item-writing guidelines to construct high quality MC items in order to increase test reliability and…

  10. Radio tuning effects on visual and driving performance measures : simulator and test track studies.

    DOT National Transportation Integrated Search

    2013-05-01

    Existing driver distraction guidelines for visual-manual device interface operation specify traditional : manual radio tuning as a reference task. This project evaluated the radio tuning reference task through two activities. : The first activity con...

  11. Analysis of Automobile Crash Test Data and Recommendations for Acquiring and Filtering Accelerometer Data

    DOT National Transportation Integrated Search

    1975-06-01

    An attempt is made to define the meaningful frequency content of occupant compartment deceleration data in order to establish effective filtering guidelines which will enhance the important features of the deceleration pulse. Acceleration and displac...

  12. Intersection collision avoidance using ITS countermeasures. Task 9, Intersection collision avoidance system performance guidelines

    DOT National Transportation Integrated Search

    2000-09-01

    Phase III of the Intersection Collision Avoidance Using ITS Countermeasures program developed testbed systems, implemented the systems on a vehicle, and performed testing to determine the potential effectiveness of this system in preventing intersect...

  13. Operability test report for the in SITU vapor sampling

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

    Corbett, J.E., Westinghouse Hanford

    1996-05-31

    This report documents the successful completion of testing for the In Situ Vapor Sampling (ISVS) system. The report includes the test procedure (WHC-SD-WM-OTP-196, Rev OA), data sheets, exception resolutions, and a test report summary. This report conforms to the guidelines established in WHC-IP-1026, `Engineering Practice Guidelines,` Appendix L, `Operability Test Procedures and Reports.`

  14. Laboratory diagnosis of creatine deficiency syndromes: a technical standard and guideline of the American College of Medical Genetics and Genomics.

    PubMed

    Sharer, J Daniel; Bodamer, Olaf; Longo, Nicola; Tortorelli, Silvia; Wamelink, Mirjam M C; Young, Sarah

    2017-02-01

    Disclaimer: These ACMG Standards and Guidelines are intended as an educational resource for clinical laboratory geneticists to help them provide quality clinical laboratory genetic services. Adherence to these standards and guidelines is voluntary and does not necessarily assure a successful medical outcome. These Standards and Guidelines should not be considered inclusive of all proper procedures and tests or exclusive of others that are reasonably directed to obtaining the same results. In determining the propriety of any specific procedure or test, clinical laboratory geneticists should apply their professional judgment to the specific circumstances presented by the patient or specimen. Clinical laboratory geneticists are encouraged to document in the patient's record the rationale for the use of a particular procedure or test, whether or not it is in conformance with these Standards and Guidelines. They also are advised to take notice of the date any particular guideline was adopted, and to consider other relevant medical and scientific information that becomes available after that date. It also would be prudent to consider whether intellectual property interests may restrict the performance of certain tests and other procedures.Cerebral creatine deficiency syndromes are neurometabolic conditions characterized by intellectual disability, seizures, speech delay, and behavioral abnormalities. Several laboratory methods are available for preliminary and confirmatory diagnosis of these conditions, including measurement of creatine and related metabolites in biofluids using liquid chromatography-tandem mass spectrometry or gas chromatography-mass spectrometry, enzyme activity assays in cultured cells, and DNA sequence analysis. These guidelines are intended to standardize these procedures to help optimize the diagnosis of creatine deficiency syndromes. While biochemical methods are emphasized, considerations for confirmatory molecular testing are also discussed, along with variables that influence test results and interpretation.Genet Med 19 2, 256-263.

  15. The Impact of 2013 Updated ASCO/CAP HER2 Guidelines on the Diagnosis and Management of Invasive Breast Cancer: A Single-Center Study of 1739 Cases.

    PubMed

    Zhang, Xiaofei; Bleiweiss, Ira; Jaffer, Shabnam; Nayak, Anupma

    2017-10-01

    The purpose of this study was to determine the impact of revised ASCO/CAP 2013 HER2 guidelines on the clinical practice of pathologists and oncologists. Retrospective analysis of 1739 patients with invasive breast carcinoma who underwent reflex HER2 (fluorescence in situ hybridization [FISH]) testing, using both 2007 and 2013 guidelines (2007-2014). Using 2013 guidelines, 255 (15%; 95% confidence interval [CI], 13%-16%) cases were classified as HER2 + as opposed to 186 (11%; 95% CI, 9%-12%) by 2007 guidelines (odds ratio [OR] 1.4; 95% CI, 1.2-1.8; P = .0005). Sixty-nine cases equivocal by 2007 guidelines (12% of all equivocal cases) were converted to HER2 + by 2013 guidelines. Sixty-two of these 69 cases shifted from HER2 equivocal to positive due to change in FISH ratio cutoff from 2.2 to 2.0. Six cases had FISH ratio < 2.0 but immunohistochemistry (IHC) score 3+ in 10% to 30% of tumor cells. One case had FISH ratio of 2.0 and IHC score 3+ in 10% to 30% of tumor cells. FISH and IHC test results were discordant in 5% (95% CI, 4%-6%) of cases using 2013 guidelines. No increase in HER2 FISH equivocal cases was observed. Reflex FISH testing of all IHC 1+ cases at our institution additionally detected 58 patients (5%; 95% CI, 4%-6%) with HER2 amplification. The 2013 guidelines increase the detection of HER2 + cases, without introducing significant difference in discordance rate of the IHC and FISH assays. Inclusion of HER2 copy number criterion does not increase the number of FISH equivocal cases in our cohort. We recommend IHC 1+ cases should be offered reflex FISH testing because failure to test them will miss a small number (5%) of potentially treatable cases. Copyright © 2017 Elsevier Inc. All rights reserved.

  16. Using a cost-benefit analysis to estimate outcomes of a clinical treatment guideline: testing theBrain Trauma Foundation guidelines for the treatment of severe traumatic brain injury.

    PubMed

    Faul, Mark; Wald, Marlena M; Rutland-Brown, Wesley; Sullivent, Ernest E; Sattin, Richard W

    2007-12-01

    A decade after promulgation of treatment guidelines by the Brain Trauma Foundation (BTF), few studies exist that examine the application of these guidelines for severe traumatic brain injury (TBI) patients. These studies have reported both cost savings and reduced mortality. We projected the results of previous studies of BTF guideline adoption to estimate the impact of widespread adoption across the United States. We used surveillance systems and national surveys to estimate the number of severely injured TBI patients and compared the lifetime costs of BTF adoption to the current state of treatment. After examining the health outcomes and costs, we estimated that a substantial savings in annual medical costs ($262 million), annual rehabilitation costs ($43 million) and lifetime societal costs ($3.84 billion) would be achieved if treatment guidelines were used more routinely. Implementation costs were estimated to be $61 million. The net savings were primarily because of better health outcomes and a decreased burden on lifetime social support systems. We also estimate that mortality would be reduced by 3,607 lives if the guidelines were followed. Widespread adoption of the BTF guidelines for the treatment of severe TBI would result in substantial savings in costs and lives. The majority of cost savings are societal costs. Further validation work to identify the most effective aspects of the BTF guidelines is warranted.

  17. Economic modelling of diagnostic and treatment pathways in National Institute for Health and Care Excellence clinical guidelines: the Modelling Algorithm Pathways in Guidelines (MAPGuide) project.

    PubMed

    Lord, J; Willis, S; Eatock, J; Tappenden, P; Trapero-Bertran, M; Miners, A; Crossan, C; Westby, M; Anagnostou, A; Taylor, S; Mavranezouli, I; Wonderling, D; Alderson, P; Ruiz, F

    2013-12-01

    National Institute for Health and Care Excellence (NICE) clinical guidelines (CGs) make recommendations across large, complex care pathways for broad groups of patients. They rely on cost-effectiveness evidence from the literature and from new analyses for selected high-priority topics. An alternative approach would be to build a model of the full care pathway and to use this as a platform to evaluate the cost-effectiveness of multiple topics across the guideline recommendations. In this project we aimed to test the feasibility of building full guideline models for NICE guidelines and to assess if, and how, such models can be used as a basis for cost-effectiveness analysis (CEA). A 'best evidence' approach was used to inform the model parameters. Data were drawn from the guideline documentation, advice from clinical experts and rapid literature reviews on selected topics. Where possible we relied on good-quality, recent UK systematic reviews and meta-analyses. Two published NICE guidelines were used as case studies: prostate cancer and atrial fibrillation (AF). Discrete event simulation (DES) was used to model the recommended care pathways and to estimate consequent costs and outcomes. For each guideline, researchers not involved in model development collated a shortlist of topics suggested for updating. The modelling teams then attempted to evaluate options related to these topics. Cost-effectiveness results were compared with opinions about the importance of the topics elicited in a survey of stakeholders. The modelling teams developed simulations of the guideline pathways and disease processes. Development took longer and required more analytical time than anticipated. Estimates of cost-effectiveness were produced for six of the nine prostate cancer topics considered, and for five of eight AF topics. The other topics were not evaluated owing to lack of data or time constraints. The modelled results suggested 'economic priorities' for an update that differed from priorities expressed in the stakeholder survey. We did not conduct systematic reviews to inform the model parameters, and so the results might not reflect all current evidence. Data limitations and time constraints restricted the number of analyses that we could conduct. We were also unable to obtain feedback from guideline stakeholders about the usefulness of the models within project time scales. Discrete event simulation can be used to model full guideline pathways for CEA, although this requires a substantial investment of clinical and analytic time and expertise. For some topics lack of data may limit the potential for modelling. There are also uncertainties over the accessibility and adaptability of full guideline models. However, full guideline modelling offers the potential to strengthen and extend the analytical basis of NICE's CGs. Further work is needed to extend the analysis of our case study models to estimate population-level budget and health impacts. The practical usefulness of our models to guideline developers and users should also be investigated, as should the feasibility and usefulness of whole guideline modelling alongside development of a new CG. This project was funded by the Medical Research Council and the National Institute for Health Research through the Methodology Research Programme [grant number G0901504] and will be published in full in Health Technology Assessment; Vol. 17, No. 58. See the NIHR Journals Library website for further project information.

  18. Preferred Reporting Items for a Systematic Review and Meta-analysis of Diagnostic Test Accuracy Studies: The PRISMA-DTA Statement.

    PubMed

    McInnes, Matthew D F; Moher, David; Thombs, Brett D; McGrath, Trevor A; Bossuyt, Patrick M; Clifford, Tammy; Cohen, Jérémie F; Deeks, Jonathan J; Gatsonis, Constantine; Hooft, Lotty; Hunt, Harriet A; Hyde, Christopher J; Korevaar, Daniël A; Leeflang, Mariska M G; Macaskill, Petra; Reitsma, Johannes B; Rodin, Rachel; Rutjes, Anne W S; Salameh, Jean-Paul; Stevens, Adrienne; Takwoingi, Yemisi; Tonelli, Marcello; Weeks, Laura; Whiting, Penny; Willis, Brian H

    2018-01-23

    Systematic reviews of diagnostic test accuracy synthesize data from primary diagnostic studies that have evaluated the accuracy of 1 or more index tests against a reference standard, provide estimates of test performance, allow comparisons of the accuracy of different tests, and facilitate the identification of sources of variability in test accuracy. To develop the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) diagnostic test accuracy guideline as a stand-alone extension of the PRISMA statement. Modifications to the PRISMA statement reflect the specific requirements for reporting of systematic reviews and meta-analyses of diagnostic test accuracy studies and the abstracts for these reviews. Established standards from the Enhancing the Quality and Transparency of Health Research (EQUATOR) Network were followed for the development of the guideline. The original PRISMA statement was used as a framework on which to modify and add items. A group of 24 multidisciplinary experts used a systematic review of articles on existing reporting guidelines and methods, a 3-round Delphi process, a consensus meeting, pilot testing, and iterative refinement to develop the PRISMA diagnostic test accuracy guideline. The final version of the PRISMA diagnostic test accuracy guideline checklist was approved by the group. The systematic review (produced 64 items) and the Delphi process (provided feedback on 7 proposed items; 1 item was later split into 2 items) identified 71 potentially relevant items for consideration. The Delphi process reduced these to 60 items that were discussed at the consensus meeting. Following the meeting, pilot testing and iterative feedback were used to generate the 27-item PRISMA diagnostic test accuracy checklist. To reflect specific or optimal contemporary systematic review methods for diagnostic test accuracy, 8 of the 27 original PRISMA items were left unchanged, 17 were modified, 2 were added, and 2 were omitted. The 27-item PRISMA diagnostic test accuracy checklist provides specific guidance for reporting of systematic reviews. The PRISMA diagnostic test accuracy guideline can facilitate the transparent reporting of reviews, and may assist in the evaluation of validity and applicability, enhance replicability of reviews, and make the results from systematic reviews of diagnostic test accuracy studies more useful.

  19. Improving the care for people with acute low-back pain by allied health professionals (the ALIGN trial): A cluster randomised trial protocol

    PubMed Central

    2010-01-01

    Background Variability between clinical practice guideline recommendations and actual clinical practice exists in many areas of health care. A 2004 systematic review examining the effectiveness of guideline implementation interventions concluded there was a lack of evidence to support decisions about effective interventions to promote the uptake of guidelines. Further, the review recommended the use of theory in the development of implementation interventions. A clinical practice guideline for the management of acute low-back pain has been developed in Australia (2003). Acute low-back pain is a common condition, has a high burden, and there is some indication of an evidence-practice gap in the allied health setting. This provides an opportunity to develop and test a theory-based implementation intervention which, if effective, may provide benefits for patients with this condition. Aims This study aims to estimate the effectiveness of a theory-based intervention to increase allied health practitioners' (physiotherapists and chiropractors in Victoria, Australia) compliance with a clinical practice guideline for acute non-specific low back pain (LBP), compared with providing practitioners with a printed copy of the guideline. Specifically, our primary objectives are to establish if the intervention is effective in reducing the percentage of acute non-specific LBP patients who are either referred for or receive an x-ray, and improving mean level of disability for patients three months post-onset of acute LBP. Methods The design of the study is a cluster randomised trial. Restricted randomisation was used to randomise 210 practices (clusters) to an intervention or control group. Practitioners in the control group received a printed copy of the guideline. Practitioners in the intervention group received a theory-based intervention developed to address prospectively identified barriers to practitioner compliance with the guideline. The intervention primarily consisted of an educational symposium. Patients aged 18 years or older who visit a participating practitioner for acute non-specific LBP of less than three months duration over a two-week data collection period, three months post the intervention symposia, are eligible for inclusion. Sample size calculations are based on recruiting between 15 to 40 patients per practice. Outcome assessors will be blinded to group allocation. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12609001022257 (date registered 25th November 2009) PMID:21067614

  20. Single Event Effects (SEE) Testing: Practical Approach to Test Plans

    NASA Technical Reports Server (NTRS)

    LaBel, Kenneth A.; Pellish, Jonathan Allen; Berg, Melanie D.

    2014-01-01

    While standards and guidelines for performing SEE testing have existed for several decades, guidance for developing SEE test plans has not been as easy to find. In this presentation, the variety of areas that need to be considered ranging from resource issues (funds, personnel, schedule) to extremely technical challenges (particle interaction and circuit application), shall be discussed. Note: we consider the approach outlined here as a "living" document: Mission-specific constraints and new technology related issues always need to be taken into account.

  1. 78 FR 25282 - Agency Information Collection Activities: Proposed Collection; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-30

    ... Project: Mandatory Guidelines for Federal Workplace Drug Testing Programs (OMB No. 0930-0158)--Revision SAMHSA's Mandatory Guidelines for Federal Workplace Drug Testing Programs will request OMB approval for the Federal Drug Testing Custody and Control Form for federal agency and federally regulated drug...

  2. EAACI food allergy and anaphylaxis guidelines: diagnosis and management of food allergy.

    PubMed

    Muraro, A; Werfel, T; Hoffmann-Sommergruber, K; Roberts, G; Beyer, K; Bindslev-Jensen, C; Cardona, V; Dubois, A; duToit, G; Eigenmann, P; Fernandez Rivas, M; Halken, S; Hickstein, L; Høst, A; Knol, E; Lack, G; Marchisotto, M J; Niggemann, B; Nwaru, B I; Papadopoulos, N G; Poulsen, L K; Santos, A F; Skypala, I; Schoepfer, A; Van Ree, R; Venter, C; Worm, M; Vlieg-Boerstra, B; Panesar, S; de Silva, D; Soares-Weiser, K; Sheikh, A; Ballmer-Weber, B K; Nilsson, C; de Jong, N W; Akdis, C A

    2014-08-01

    Food allergy can result in considerable morbidity, impact negatively on quality of life, and prove costly in terms of medical care. These guidelines have been prepared by the European Academy of Allergy and Clinical Immunology's (EAACI) Guidelines for Food Allergy and Anaphylaxis Group, building on previous EAACI position papers on adverse reaction to foods and three recent systematic reviews on the epidemiology, diagnosis, and management of food allergy, and provide evidence-based recommendations for the diagnosis and management of food allergy. While the primary audience is allergists, this document is relevant for all other healthcare professionals, including primary care physicians, and pediatric and adult specialists, dieticians, pharmacists and paramedics. Our current understanding of the manifestations of food allergy, the role of diagnostic tests, and the effective management of patients of all ages with food allergy is presented. The acute management of non-life-threatening reactions is covered in these guidelines, but for guidance on the emergency management of anaphylaxis, readers are referred to the related EAACI Anaphylaxis Guidelines. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  3. Could a revision of the current guidelines for cancer drug use improve the quality of cancer treatment?

    PubMed

    Lippert, Theodor H; Ruoff, Hans-Jörg; Volm, Manfred

    2014-01-01

    Clinical practice guidelines are indispensable for such a variable disease as malignant solid tumors, with the complex possibilities of drug treatment. The current guidelines may be criticized on several points, however. First, there is a lack of information on the outcome of treatment, such as the expected success and failure rates. Treating not only drug responders but also nonresponders, that is, patients with drug resistance, must result in failures. There is no mention of the possibility of excluding the drug nonresponders, identifiable by special laboratory tests and no consideration is given to the different side effects of the recommended drug regimens. Nor are there any instructions concerning tumor cases for which anticancer drug treatment is futile. In such cases, early palliative care may lead to significant improvements in both life quality and life expectancy. Not least, there is no transparency concerning the preparation of the guidelines: persons cannot be identified who could give a statement of conflicts of interest, and responsibility is assumed only by anonymous medical associations. A revision of the current guidelines could considerably improve cancer treatment.

  4. Improvement in safety monitoring of biologic response modifiers after the implementation of clinical care guidelines by a specialty.

    PubMed

    Hanson, Rebekah L; Gannon, Michael J; Khamo, Nehrin; Sodhi, Monsheel; Orr, Alexander M; Stubbings, JoAnn

    2013-01-01

    Tumor necrosis factor (TNF)-alpha inhibitors and other biologic response modifiers (BRMs) are frequently used to treat a variety of inflammatory diseases. Use of these agents may increase risk of serious infections, malignancies, and other complications such as worsening symptoms of heart failure or demyelinating disease. Because of these risks, a baseline assessment and routine monitoring have been recommended, but standardized guidelines for monitoring have yet to be established. To measure the compliance with the recommended safety monitoring in the Clinical Care Guidelines for BRMs at the University of Illinois Hospitals and Health Sciences System (UI Health). The Clinical Care Guidelines for BRMs was developed by a committee of pharmacists, nurses, and physicians based on an assessment of published literature and medication labeling. The guidelines included recommendations for safety monitoring prior to BRM therapy, such as the tuberculosis (TB) test, Hepatitis B surface Antigen (HBsAg) test, liver function test (LFT), complete blood count (CBC), up-to-date vaccinations, risk assessment for cancer, pregnancy testing, monitoring for contraindications with concomitant medications, concomitant disease state risk assessment, and patient education. The guidelines were introduced to UI Health in February 2012 by a systemwide email and by in-services given by the health system's Specialty Pharmacy Service. In-services were given in the clinics known to generate large numbers of BRM orders (e.g., gastroenterology and rheumatology) and at the outpatient center for infused therapies. The purpose of the in-services was to introduce providers to the guidelines and encourage their compliance. To ensure that guideline requirements were met when BRMs were ordered, a process was established to identify BRM orders, assess the orders for compliance with 4 of the safety monitoring tests from the guidelines (TB, HBsAg, LFT, and CBC), and make interventions. When necessary, Specialty Pharmacy Services coordinated with the pharmacists and other providers in the clinic to order lab tests and ensure they were completed prior to the start of therapy. Feedback was provided during the study to proactively improve compliance with the guidelines. After completion of the study, a report containing outpatient prescription orders for BRMs (abatacept, adalimumab, certolizumab, etanercept, golimumab, infliximab, and tocilizumab) from August 2011 through July 2012 was generated from the electronic medical record. Retrospective analyses of completion of safety monitoring were conducted for patients administered BRM treatment. Completion rates were compared before and after implementation of guidelines in February 2012. Completion was considered to have occurred when all 4 safety monitoring tests had been conducted -TB (unless known to be positive from a previous test), HBsAg, LFT, and CBC. Completion data from August 2011 through January 2012 were before the guidelines were implemented, and data from February 2012 through July 2012 were after the guidelines. Chi square analyses were performed on completion frequencies in the patients before and after the guidelines were implemented. Of the 320 unique patient BRM orders evaluated in this study, 195 (61%) were generated in the Rheumatology clinic, 99 (31%) in the Gastroenterology clinic, 21 (6.5%) in the Dermatology clinic, and 5 (1.5%) in the Transplant clinic. Before the guidelines were implemented, 54 ( 31%) of 173 patient orders complied with the safety monitoring by having all 4 clinical tests performed at the appropriate time points. After guideline implementation, 88 (60%) of 147 patient orders were compliant and had all 4 clinical tests conducted, which represents a statistically significant improvement in the rate of compliance (Pearson chi square = 26.43, degrees of freedom (df) = 1, P  less than  0.0001). This significant improvement in compliance rates after guideline implementation was observed in both the new patient group and the patients with continuing prescription orders/treatment changes. There was also an improvement in patients whose prescriptions were dispensed by UI Health and to a lesser degree those whose prescriptions were dispensed by an outside pharmacy. When the new patient group was analyzed separately (n = 92), 50 patients were treated before the guidelines were implemented, and 42 patients were treated after the guidelines were implemented. Compliance rates with safety monitoring in these 2 groups were 52% pre-implementation and 83% post-implementation, which represented a statistically significant improvement in compliance (Pearson chi square = 10.03, df=1, P = 0.0015). Similar results were observed in the second patient subgroup with continuing prescription orders/treatment change (n = 228). A total of 123 patients were treated before the guidelines were implemented, and 105 were treated after the guidelines were implemented. Compliance rates were 23% pre-implementation compared with 50% post-implementation, which represented a statistically significant improvement in compliance (Pearson chi square = 18.99, df = 1, P  less than  0.0001). Given the widespread and long-term use of BRMs, safety monitoring and management should be an important part of a comprehensive medication management program for their use. A coordinated effort may have a significant impact on compliance with safety monitoring guidelines.

  5. Extended One-Generation Reproductive Toxicity Test in Rats Exposed to 3-Nitro-1,2,4 Triazol-5-One (NTO), October 2013-March 2014

    DTIC Science & Technology

    2016-04-01

    formulations, NTO must not only meet certain performance criteria, but must also be acceptable from the perspective of human health and the environment...veterinary medical personnel for husbandry conditions, humane care, and general health status. In the event an animal becomes ill or injured, veterinary or...Office of Prevention, Pesticides , and Toxic Substances. 2009a. Health Effects Test Guidelines: OPPTS 870.3800 Reproduction and Fertility Effects. U.S

  6. Guidelines for Standardized Testing of Broadband Seismometers and Accelerometers

    USGS Publications Warehouse

    Hutt, Charles R.; Evans, John R.; Followill, Fred; Nigbor, Robert L.; Wielandt, Erhard

    2010-01-01

    Testing and specification of seismic and earthquake-engineering sensors and recorders has been marked by significant variations in procedures and selected parameters. These variations cause difficulty in comparing such specifications and test results. In July 1989, and again in May 2005, the U.S. Geological Survey hosted international pub-lic/private workshops with the goal of defining widely accepted guidelines for the testing of seismological inertial sensors, seismometers, and accelerometers. The Proceedings of the 2005 workshop have been published and include as appendix 6 the report of the 1989 workshop. This document represents a collation and rationalization of a single set of formal guidelines for testing and specifying broadband seismometers and accelerometers.

  7. In honor of the Teratology Society's 50th anniversary: The role of Teratology Society members in the development and evolution of in vivo developmental toxicity test guidelines.

    PubMed

    Tyl, Rochelle W

    2010-06-01

    Members of the Teratology Society (established in 1960) were involved in the first governmental developmental and reproductive toxicity testing guidelines (1966) by FDA following the thalidomide epidemic, followed by other national and international governmental testing guidelines. The Segment II (developmental toxicity) study design, described in rodents and rabbits, has evolved with additional enhanced endpoints and better descriptions, mechanistic insights, range-finding studies, and toxico/pharmacokinetic ADME information (especially for pharmaceuticals). Society members were also involved in the development of the current screening assays and tests for endocrine disruptors (beginning in 1996) and are now involved with developing new testing guidelines (e.g., the extended one-generation protocol), and evaluating the current test guidelines and new initiatives under ILSI/HESI sponsorship. New initiatives include ToxCast from the U.S. EPA to screen, prioritize, and predict toxic chemicals by high throughput and high-content in vitro assays, bioinformation, and modeling to reduce (or eliminate) in vivo whole animal studies. Our Society and its journal have played vital roles in the scientific and regulatory accomplishments in birth defects research over the past 50 years and will continue to do so in the future. Happy 50th anniversary! (c) 2010 Wiley-Liss, Inc.

  8. Guidelines for the Design, Fabrication, Testing, Installation and Operation of Srf Cavities

    NASA Astrophysics Data System (ADS)

    Theilacker, J.; Carter, H.; Foley, M.; Hurh, P.; Klebaner, A.; Krempetz, K.; Nicol, T.; Olis, D.; Page, T.; Peterson, T.; Pfund, P.; Pushka, D.; Schmitt, R.; Wands, R.

    2010-04-01

    Superconducting Radio-Frequency (SRF) cavities containing cryogens under pressure pose a potential rupture hazard to equipment and personnel. Generally, pressure vessels fall within the scope of the ASME Boiler and Pressure Vessel Code however, the use of niobium as a material for the SRF cavities is beyond the applicability of the Code. Fermilab developed a guideline to ensure sound engineering practices governing the design, fabrication, testing, installation and operation of SRF cavities. The objective of the guideline is to reduce hazards and to achieve an equivalent level of safety afforded by the ASME Code. The guideline addresses concerns specific to SRF cavities in the areas of materials, design and analysis, welding and brazing, pressure relieving requirements, pressure testing and quality control.

  9. 75 FR 41488 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-16

    .... Project: Mandatory Guidelines for Federal Workplace Drug Testing Programs (OMB No. 0930-0158)--Revision SAMHSA's Mandatory Guidelines for Federal Workplace Drug Testing Programs will request OMB approval for the Federal Drug Testing Custody and Control Form for Federal agency and federally regulated drug...

  10. 77 FR 52610 - Pesticides; Microbial Pesticide Definitions and Applicability; Clarification and Availability of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-30

    ... Pesticides; Microbial Pesticide Definitions and Applicability; Clarification and Availability of Test... pesticide test guideline that further explains the existing data requirement to deposit a sample in a... as the final microbial pesticide test guideline, are expected to enhance the ability of industry to...

  11. Distributed Training for the Reserve Component: Remote Delivery Using Asynchronous Computer Conferencing.

    ERIC Educational Resources Information Center

    Hahn, H. A.; And Others

    The purposes of this research were to evaluate the cost effectiveness of using Asynchronous Computer Conferencing (ACC) and to develop guidelines for effectively conducting high quality military training using ACC. The evaluation used a portion of the Engineer Officer Advanced Course (EOAC) as a test bed. Course materials which taught the same…

  12. How to Write Effective Procedure Manuals.

    ERIC Educational Resources Information Center

    Wold, Geoffrey H.

    1987-01-01

    Describes six key guidelines for developing usable procedure manuals, including defining the audience; designing a standard format; preparing an outline; using a clear, concise writing style; testing the procedures; and "finalizing" the product with indices, glossaries, appendices, and section tabs. Well-written manuals can increase…

  13. The Developmental Neurotoxicity Guideline Study: Issues with Methodology, Evaluation and Regulation

    EPA Science Inventory

    Recently social concerns are increasing for the effects of environmental factors on children's health, especially on their nervous system. The U.S. Environmental Protection Agency (EPA) and the Organization for Economic Co-operation and Development (GECD) have published testing ...

  14. MODIFYING THE AVIAN REPRODUCTION TEST GUIDELINES FOR DETERMINING DOSE-RESPONSE RELATIONSHIPS

    EPA Science Inventory

    As a subgroup of the OECD Expert Group on Assessment of Endocrine Disrupting Effects in Birds, we reviewed unresolved methodological issues important for the development of a two-generation toxicity text, discussed advantages and disadvantages of alternative approaches, and propo...

  15. 40 CFR 798.5460 - Rodent heritable translocation assays.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... treatment and control groups. (4) Control groups—(i) Concurrent controls. No concurrent positive or negative... control groups. Historical or concurrent controls shall be specified, as well as the randomization... SUBSTANCES CONTROL ACT (CONTINUED) HEALTH EFFECTS TESTING GUIDELINES Genetic Toxicity § 798.5460 Rodent...

  16. 40 CFR 798.5460 - Rodent heritable translocation assays.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... treatment and control groups. (4) Control groups—(i) Concurrent controls. No concurrent positive or negative... control groups. Historical or concurrent controls shall be specified, as well as the randomization... SUBSTANCES CONTROL ACT (CONTINUED) HEALTH EFFECTS TESTING GUIDELINES Genetic Toxicity § 798.5460 Rodent...

  17. 40 CFR 798.5460 - Rodent heritable translocation assays.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... treatment and control groups. (4) Control groups—(i) Concurrent controls. No concurrent positive or negative... control groups. Historical or concurrent controls shall be specified, as well as the randomization... SUBSTANCES CONTROL ACT (CONTINUED) HEALTH EFFECTS TESTING GUIDELINES Genetic Toxicity § 798.5460 Rodent...

  18. 40 CFR 798.5460 - Rodent heritable translocation assays.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... treatment and control groups. (4) Control groups—(i) Concurrent controls. No concurrent positive or negative... control groups. Historical or concurrent controls shall be specified, as well as the randomization... SUBSTANCES CONTROL ACT (CONTINUED) HEALTH EFFECTS TESTING GUIDELINES Genetic Toxicity § 798.5460 Rodent...

  19. 40 CFR 798.5460 - Rodent heritable translocation assays.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... treatment and control groups. (4) Control groups—(i) Concurrent controls. No concurrent positive or negative... control groups. Historical or concurrent controls shall be specified, as well as the randomization... SUBSTANCES CONTROL ACT (CONTINUED) HEALTH EFFECTS TESTING GUIDELINES Genetic Toxicity § 798.5460 Rodent...

  20. 40 CFR 795.225 - Dermal pharmacokinetics of DGBE and DGBA.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 32 2014-07-01 2014-07-01 false Dermal pharmacokinetics of DGBE and DGBA. 795.225 Section 795.225 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) PROVISIONAL TEST GUIDELINES Provisional Health Effects...

  1. 40 CFR 795.225 - Dermal pharmacokinetics of DGBE and DGBA.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 32 2011-07-01 2011-07-01 false Dermal pharmacokinetics of DGBE and DGBA. 795.225 Section 795.225 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) PROVISIONAL TEST GUIDELINES Provisional Health Effects...

  2. 40 CFR 795.225 - Dermal pharmacokinetics of DGBE and DGBA.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 33 2013-07-01 2013-07-01 false Dermal pharmacokinetics of DGBE and DGBA. 795.225 Section 795.225 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) PROVISIONAL TEST GUIDELINES Provisional Health Effects...

  3. 40 CFR 795.225 - Dermal pharmacokinetics of DGBE and DGBA.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 33 2012-07-01 2012-07-01 false Dermal pharmacokinetics of DGBE and DGBA. 795.225 Section 795.225 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) PROVISIONAL TEST GUIDELINES Provisional Health Effects...

  4. Combined use of fasting plasma glucose and glycated hemoglobin A1c in a stepwise fashion to detect undiagnosed diabetes mellitus.

    PubMed

    Nakagami, Tomoko; Tominaga, Makoto; Nishimura, Rimei; Daimon, Makoto; Oizumi, Toshihide; Yoshiike, Nobuo; Tajima, Naoko

    2007-09-01

    Type 2 diabetes mellitus (DM) is a common and serious condition related with considerable morbidity. Screening for DM is one strategy for reducing this burden. In Japan National Diabetes Screening Program (JNDSP) guideline, the combined use of fasting plasma glucose (FPG) and glycated hemoglobin A1c (HbA1c) in a stepwise fashion has been recommended to identify the group of people needing life-style counseling or medical care. However, the efficacy of this program has not been fully evaluated, as an oral glucose tolerance test (OGTT) is not mandatory in the guideline. The aim of this study was to assess the validity of the screening test scenario, in which an OGTT would be applied to people needing life-style counseling or medical care on this guideline: FPG 110-125 mg/dl and HbA1c over 5.5%. Subjects were 1,726 inhabitants without a previous history of DM in the Funagata study, which is a population-based survey conducted in Yamagata prefecture to clarify the risk factors, related conditions, and consequences of DM. DM was diagnosed according to the 1999 World Health Organization criteria. The prevalence of undiagnosed DM was 6.6%. The tested screening scenario gave a sensitivity of 55.3%, a specificity of 98.4%, a positive predictive value of 70.8%, and a negative predictive value of 96.9% for undiagnosed DM. In conclusion, the screening test scenario, in which an OGTT would be followed by the combined use of FPG and HbA1c in a stepwise fashion according to the JNDSP guideline, was not effective in identifying people with undiagnosed DM.

  5. Comparison between diagnosis and treatment of community-acquired pneumonia in children in various medical centres across Europe with the United States, United Kingdom and the World Health Organization guidelines.

    PubMed

    Usonis, Vytautas; Ivaskevicius, Rimvydas; Diez-Domingo, Javier; Esposito, Susanna; Falup-Pecurariu, Oana G; Finn, Adam; Rodrigues, Fernanda; Spoulou, Vana; Syrogiannopoulos, George A; Greenberg, David

    2016-01-01

    The aim of this study was to review the current status and usage of guidelines in the diagnosis and treatment of community-acquired pneumonia (CAP) in European countries and to compare to established guidelines in the United States (US), United Kingdom (UK), and the World Health Organization (WHO). A questionnaire was developed and distributed by the Community-Acquired Pneumonia Paediatric Research Initiative (CAP-PRI) working group and distributed to medical centres across Europe. Out of 19 European centres, 6 (31.6 %) used WHO guidelines (3 in combination with other guidelines), 5 (26.3 %) used national guidelines, and 5 (26.3 %) used local guidelines. Chest radiograph and complete blood count were the most common diagnostic examinations, while evaluation of clinical symptoms and laboratory tests varied significantly. Tachypnoea and chest recession were considered criteria for diagnosis in all three guidelines. In US and UK guidelines blood cultures, atypical bacterial and viral detection tests were recommended. In European centres in outpatient settings, amoxicillin was used in 16 (84 %) centers, clarithromycin in 9 (37 %) centers and azithromycin in 7 (47 %) centers, whereas in hospital settings antibiotic treatment varied widely. Amoxicillin is recommended as the first drug of choice for outpatient treatment in all guidelines. Although local variations in clinical criteria, laboratory tests, and antibiotic resistance rates may necessitate some differences in standard empirical antibiotic regimens, there is considerable scope for standardisation across European centres for the diagnosis and treatment of CAP.

  6. Sustainable design guidelines to support the Washington State ferries terminal design manual : design guideline application and refinement.

    DOT National Transportation Integrated Search

    2013-08-01

    The Sustainable Design Guidelines were developed in Phase I of this research program (WA-RD : 816.1). Here we are reporting on the Phase II effort that beta-tested the Phase I Guidelines on : example ferry terminal designs and refinements made ...

  7. Acute and sub-chronic toxicity of four cytostatic drugs in zebrafish.

    PubMed

    Kovács, Róbert; Bakos, Katalin; Urbányi, Béla; Kövesi, Judit; Gazsi, Gyöngyi; Csepeli, Andrea; Appl, Ádám János; Bencsik, Dóra; Csenki, Zsolt; Horváth, Ákos

    2016-08-01

    The acute and sub-chronic effects of four cytostatic drugs-5-fluorouracil (5-FU), cisplatin (CisPt), etoposide (ET) and imatinib mesylate (IM)-on zebrafish (Danio rerio) were investigated. Acute tests were carried out in a static system in accordance with the OECD guideline 203 for adult fish and the draft guideline for fish embryos (FET test) in order to find the LC50 values of the four cytostatic drugs. Early-life stage toxicity test on zebrafish was conducted according the OECD guideline 210 using the cytostatic drugs 5-FU and IM in a semistatic system with the objective of investigating the sub-chronic effects of the cytostatic drugs on fish. In adult fish, the cytostatic drugs 5-FU and ET did not pass the limit test, thus, are considered non-toxic. In case of cisplatin, LC50 was calculated at 64.5 mg L(-1), whereas in case of IM, LC50 was at 70.8 mg L(-1). In the FET test, LC50 of 5-FU at 72-h post fertilization (hpf) was 2441.6 mg L(-1). In case of CisPt, LC50 was 349.9 mg L(-1) at 48 hpf and it progressively decreased to 81.3 mg L(-1) at 120 hpf. In addition, CisPt caused a significant delay in the hatch of larvae. In case of ET, LC50 values were not calculable as they were higher than 300 mg L(-1) at which concentration the substance crystallized in the solution. LC50 values of IM were 48 hpf; 158.3 mg L(-1) , 72 hpf; 141.6 mg L(-1), 96 hpf; 118.0 mg L(-1), and 120 hpf; 65.9 mg L(-1). In the Early-life Stage Test with 5-FU, embryonic deformities were not detected during the tests. Regarding mortalities, the 10 mg L(-1) concentration can be considered as LOEC, as statistically significant difference in mortalities was detected in this group alone. Concerning dry body weight and standard length, 1 mg L(-1) is the LOEC. In case of IM, the highest tested concentration (10 mg L(-1)) can be considered LOEC for mortalities, however, the treatment did not have an effect on the other investigated parameters (dry and wet weight, standard length). All four cytostatic drugs were characterized by low toxicity in zebrafish in acute and sub-chronic tests.

  8. Cervical Cancer Screening Guideline Adherence Before and After Guideline Changes in Pennsylvania Medicaid.

    PubMed

    Parekh, Natasha; Donohue, Julie M; Men, Aiju; Corbelli, Jennifer; Jarlenski, Marian

    2017-01-01

    To assess changes in cervical cancer screening after the 2009 American College of Obstetricians and Gynecologists' guideline change and to determine predictors associated with underscreening and overscreening among Medicaid-enrolled women. We performed an observational cohort study of Pennsylvania Medicaid claims from 2007 to 2013. We evaluated guideline adherence of 18- to 64-year-old continuously enrolled women before and after the 2009 guideline change. To define adherence, we categorized intervals between Pap tests as longer than (underscreening), within (appropriate screening), or shorter than (overscreening) guideline-recommended intervals (±6-month). We stratified results by age and assessed predictors of underscreening and overscreening through logistic regression. Among 29,650 women, appropriate cervical cancer screening significantly decreased after the guideline change (from 45% [95% confidence interval (CI) 44-46%] to 11% [95% CI 11-12%] among 17,360 younger than 30 year olds and from 27% [95% CI 26-28%] to 6% [95% CI 6-7%] among 12,290 women 30 years old or older). Overscreening significantly increased (from 6% [95% CI 5-6%] to 67% [95% CI 66-68%] in those younger than 30 years old and from 54% [95% CI 52-55%] to 65% [95% CI 64-67%] in those 30 years old or older), whereas underscreening significantly increased only in those 30 years old or older (from 20% [95% CI 19-21%] to 29% [95% CI 27-30%]). Pap tests after guideline change, pregnancy, Managed Care enrollment (in those younger than 30 years old), and black race (in those younger than 30 years old) were associated with underscreening. Pap tests after guideline change, more visits, more sexually transmitted infection testing, and white race (in those 30 years old or older) were associated with overscreening. We observed high rates of cervical cancer overscreening and underscreening and low rates of appropriate screening after the guideline change. Interventions should target both underscreening and overscreening to address these separate yet significant issues.

  9. Guideline Adherence Regarding the Use of Expensive Drugs in Daily Practice: The Examples of Trastuzumab in Breast Cancer and Bortezomib in Multiple Myeloma.

    PubMed

    Boons, Christel C L M; Wagner, Cordula; Hugtenburg, Jacqueline G

    2016-01-01

    The present study was designed to obtain insights into guideline adherence regarding the use of expensive drugs in The Netherlands in daily practice and into the patients' perspective on the decision-making process. A retrospective review of medical charts regarding the use of trastuzumab in early and metastatic breast cancer (EBC/MBC) and bortezomib in multiple myeloma (MM) was conducted. Prescription according to clinical practice guidelines was assessed. The review was supplemented with patient interviews. Of 702 adjuvant-treated EBC patients, 97% had a documented human epidermal growth factor receptor 2 (HER2) testing (23% HER2 positive). 92% (147/160) of the HER2-positive EBC patients were treated with trastuzumab. Of 594 MBC patients, 81% had a documented HER2 testing (19% HER2 positive). 82% (75/91) of the HER2-positive MBC patients were treated with trastuzumab. Of 68 MM patients, 50% were treated with bortezomib. Reasons not to treat were consistent with the guidelines. Patients were generally satisfied with the decision-making process; improvements in patient education were suggested (e.g., repeating the information given, adding information on side effects). Guidelines were generally well followed with respect to trastuzumab and bortezomib, indicating that funding did not influence the treatment decisions of physicians. In view of the growing numbers of both cancer patients and expensive new anticancer drugs, and increasing budget constraints, it is unclear whether the present-day policies will guarantee a similar level of guideline adherence. Patient involvement in decision-making could be increased by improving the patient education on treatment. © 2016 S. Karger GmbH, Freiburg.

  10. [NPT (near patient test) in the pharmacy: document and practice guidelines 2008].

    PubMed

    Stuard, S; Cesarone, M R; Belcaro, G; Ledda, A; Cornelli, U; Di Renzo, A; Grossi, M G; Pellegrini, L; Gizzi, G; Vinciguerra, G; Dugall, M; Corsi, M; Ippolito, E; Di Palma, T; Zulli, C; Del Boccio, G

    2008-10-01

    NPT tests in the pharmacy. Blood testing can be made with NPT (near patient testing) directly in the pharmacy. Most tests can be made with a single drop of blood (i.e. from a finger) and results are comparable with results from blood test obtained with standard vein blood samples. NPT is basically used for: 1 - evaluating the risk of a disease. 2 evaluating or confirming the presence of a disease. 3 to manage and monitor treatments. The social role of the pharmacy in NPT (particularly in cardiovascular screening) is very important as the pharmacy is an institution with capillary diffusion in the territory. The pharmacy often constitutes an important, first-level consultancy point for the population, particularly where health institutions are far away (small villages) or not easily accessible. Rules for NPT. Guidelines for NPT testing in the pharmacy have been proposed and discussed in a consensus meeting (Spoleto, 2007). NPT guidelines suggest operating management and technical procedures and indicate prospective lines of action defining new roles for the pharmacy. Coagulation tests can be now made in the pharmacy at a very low cost and with an efficacy comparable to blood tests obtained with a vein sample. Results can be read in seconds. This test is also available for personal use and home testing. NPT: The Clinical Study. The evaluation of the results of a clinical study (patients with venous thrombosis/pulmonary embolisation, patients with fibrillation and patients with artificial cardiac valves) indicates that costing is very favourable for NPT which may reduce costs and improve management of many clinical conditions and their monitoring. Training and control systems help NPT testing to be reliable and useful to screen and manage most clinical and risk conditions. The clinical study also shows the positive correlation between NPT tests and standard' tests. In conclusion NPT tests are now very reliable and cost-effective and can be used for screening, diagnosis and to monitor treatments.

  11. Research to develop guidelines for cathodic protection of concentric neutral cables, volume 1

    NASA Astrophysics Data System (ADS)

    Hanck, J. A.; Nekoksa, G.

    1981-08-01

    Data associated with corrosion of concentric neutrals (CN) of direct buried cables from field tests conducted at 36 bellholes excavated in California, Oklahoma, and North Carolina are presented. The electrochemical, chemical, bacteriological, and sieve analyses of native soil and imported backfill samples are included. Up to 129 values were determined for each bellhole and stored on cards as a data bank. All values were statistically analyzed and correlated with corrosion found. The severity of corrosion correlated best with CN corrosion potentials, CN resistance measurements, coarseness of backfill, and soil resistivity. The guidelines for installation of cathodic protection on CN cables are to be based upon the evaluation of over 100 experimental cathodic protection systems and upon laboratory testing for protection criteria with and without ac effects.

  12. [Causes of death among pilots: "acute myocardial infarction"--are the present examination methods for airworthiness sufficient?].

    PubMed

    Germerott, Tanja; Fieguth, Armin; Albrecht, Knut; Eidam, Joachim; Breitmeier, Dirk

    2009-01-01

    The European Union plans to harmonize the aviation requirements, in particular the flight crew licensing requirements. On 23 May 2007, the German Federal Ministry of Transport, Building and Urban Affairs published the Flight Crew Licensing Requirements, which are based on the Joint Aviation Requirements, Flight Crew Licensing 3, Amendment 5. These guidelines also list the examination methods to be used for testing the medical fitness of pilots. In this Amendment some examinations which were part of the routine tests before JAR-FCL3 became effective have been deleted, e.g. the exercise ECG. This article presents two cases from the autopsy material of the Institute of Legal Medicine in Hanover and discusses the problems associated with the new examination guidelines.

  13. A Summary of Worldwide National Activities in Chronic Kidney Disease (CKD) Testing

    PubMed Central

    Ruiz-Arenas, Roberto; Sierra-Amor, Rosa; Seccombe, David; Raymondo, Stella; Graziani, Maria Stella; Panteghini, Mauro; Adedeji, Tewogbade A.; Kamatham, Shanthi Naidu

    2017-01-01

    Chronic kidney disease (CKD) is a major public health issue worldwide and is associated with adverse health outcomes, especially in low- and middle-income countries. In a cash limited healthcare system, guidelines that improve the efficiency of health care free up resources needed for other healthcare services. This short review presents some examples from national acitivities in CKD testing, including countries throughout the globe: Mexico in North America, Uruguay in South America, Italy in Europe, Nigeria in Africa and India in Asia. Considering the fact that treatment of CKD is cost-effective and improves outcomes, this observation argue in favor of including CKD in national guidelines and noncommunicable chronic disease (NCD) programs. This diverse example of national activities fullfil the very first step in achieving this goal. PMID:29333149

  14. Development and evaluation of consensus-based sediment effect concentrations for polychlorinated biphenyls

    USGS Publications Warehouse

    MacDonald, Donald D.; Dipinto, Lisa M.; Field, Jay; Ingersoll, Christopher G.; Long, Edward R.; Swartz, Richard C.

    2000-01-01

    Sediment-quality guidelines (SQGs) have been published for polychlorinated biphenyls (PCBs) using both empirical and theoretical approaches. Empirically based guidelines have been developed using the screening-level concentration, effects range, effects level, and apparent effects threshold approaches. Theoretically based guidelines have been developed using the equilibrium-partitioning approach. Empirically-based guidelines were classified into three general categories, in accordance with their original narrative intents, and used to develop three consensus-based sediment effect concentrations (SECs) for total PCBs (tPCBs), including a threshold effect concentration, a midrange effect concentration, and an extreme effect concentration. Consensus-based SECs were derived because they estimate the central tendency of the published SQGs and, thus, reconcile the guidance values that have been derived using various approaches. Initially, consensus-based SECs for tPCBs were developed separately for freshwater sediments and for marine and estuarine sediments. Because the respective SECs were statistically similar, the underlying SQGs were subsequently merged and used to formulate more generally applicable SECs. The three consensus-based SECs were then evaluated for reliability using matching sediment chemistry and toxicity data from field studies, dose-response data from spiked-sediment toxicity tests, and SQGs derived from the equilibrium-partitioning approach. The results of this evaluation demonstrated that the consensus-based SECs can accurately predict both the presence and absence of toxicity in field-collected sediments. Importantly, the incidence of toxicity increases incrementally with increasing concentrations of tPCBs. Moreover, the consensus-based SECs are comparable to the chronic toxicity thresholds that have been estimated from dose-response data and equilibrium-partitioning models. Therefore, consensus-based SECs provide a unifying synthesis of existing SQGs, reflect causal rather than correlative effects, and accurately predict sediment toxicity in PCB-contaminated sediments.

  15. Health Information in Bengali (Bangla / বাংলা)

    MedlinePlus

    ... Society Guidelines for the Early Detection of Cancer - English PDF American Cancer Society Guidelines for the Early ... Screening It's a Simple Test - Cervical Cancer Screening - English PDF It's a Simple Test - Cervical Cancer Screening - ...

  16. Laboratory compliance with the American Society of Clinical Oncology/college of American Pathologists guidelines for human epidermal growth factor receptor 2 testing: a College of American Pathologists survey of 757 laboratories.

    PubMed

    Nakhleh, Raouf E; Grimm, Erin E; Idowu, Michael O; Souers, Rhona J; Fitzgibbons, Patrick L

    2010-05-01

    To ensure quality human epidermal growth receptor 2 (HER2) testing in breast cancer, the American Society of Clinical Oncology/College of American Pathologists guidelines were introduced with expected compliance by 2008. To assess the effect these guidelines have had on pathology laboratories and their ability to address key components. In late 2008, a survey was distributed with the HER2 immunohistochemistry (IHC) proficiency testing program. It included questions regarding pathology practice characteristics and assay validation using fluorescence in situ hybridization or another IHC laboratory assay and assessed pathologist HER2 scoring competency. Of the 907 surveys sent, 757 (83.5%) were returned. The median laboratory accessioned 15 000 cases and performed 190 HER2 tests annually. Quantitative computer image analysis was used by 33% of laboratories. In-house fluorescence in situ hybridization was performed in 23% of laboratories, and 60% of laboratories addressed the 6- to 48-hour tissue fixation requirement by embedding tissue on the weekend. HER2 testing was performed on the initial biopsy in 40%, on the resection specimen in 6%, and on either in 56% of laboratories. Testing was validated with only fluorescence in situ hybridization in 47% of laboratories, whereas 10% of laboratories used another IHC assay only; 13% used both assays, and 12% and 15% of laboratories had not validated their assays or chose "not applicable" on the survey question, respectively. The 90% concordance rate with fluorescence in situ hybridization results was achieved by 88% of laboratories for IHC-negative findings and by 81% of laboratories for IHC-positive cases. The 90% concordance rate for laboratories using another IHC assay was achieved by 80% for negative findings and 75% for positive cases. About 91% of laboratories had a pathologist competency assessment program. This survey demonstrates the extent and characteristics of HER2 testing. Although some American Society of Clinical Oncology/College of American Pathologists guidelines have been implemented, gaps remain in validation of HER2 IHC testing.

  17. Acute aquatic toxicity and biodegradation potential of biodiesel fuels

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

    Haws, R.A.; Zhang, X.; Marshall, E.A.

    1995-12-31

    Recent studies on the biodegradation potential and aquatic toxicity of biodiesel fuels are reviewed. Biodegradation data were obtained using the shaker flask method observing the appearance of CO{sub 2} and by observing the disappearance of test substance with gas chromatography. Additional BOD{sub 5} and COD data were obtained. The results indicate the ready biodegradability of biodiesel fuels as well as the enhanced co-metabolic biodegradation of biodiesel and petroleum diesel fuel mixtures. The study examined reference diesel, neat soy oil, neat rape oil, and the methyl and ethyl esters of these vegetable oils as well as various fuel blends. Acute toxicitymore » tests on biodiesel fuels and blends were performed using Oncorhynchus mykiss (Rainbow Trout) in a static non-renewal system and in a proportional dilution flow replacement system. The study is intended to develop data on the acute aquatic toxicity of biodiesel fuels and blends under US EPA Good Laboratory Practice Standards. The test procedure is designed from the guidelines outlined in Methods for Measuring the Acute Toxicity of Effluents and Receiving Waters to Freshwater and Marine Organisms and the Fish Acute Aquatic Toxicity Test guideline used to develop aquatic toxicity data for substances subject to environmental effects test regulations under TSCA. The acute aquatic toxicity is estimated by an LC50, a lethal concentration effecting mortality in 50% of the test population.« less

  18. Effectiveness of an interactive postgraduate educational intervention with patient participation on the adherence to a physiotherapy guideline for hip and knee osteoarthritis: a randomised controlled trial.

    PubMed

    Peter, Wilfred; van der Wees, Philip J; Verhoef, John; de Jong, Zusana; van Bodegom-Vos, Leti; Hilberdink, Wim K H A; Fiocco, Marta; Vliet Vlieland, Thea P M

    2015-01-01

    To determine the effectiveness of an interactive educational intervention on a physiotherapy guideline for hip and knee osteoarthritis. Physiotherapists were randomly allocated to a 3-h interactive educational course with the collaboration of three patient partners or no intervention. Assessments comprised questionnaires on adherence (score range 0-24), knowledge (score range 0-76), and barriers to use the guideline (score range 0-80). Assessments were conducted 1 week before the interactive course (T0) immediately after (T1), and 3 months thereafter (T2). Change scores were compared between the groups by means of Mann-Whitney U tests and linear mixed models. 284 of 4328 eligible PTs (7%) were included. The intervention (n = 133) was significantly more effective than no intervention (n = 151) concerning self-reported adherence and knowledge with mean differences in change scores (95% CI) at T1 and T2 being 1.4 (0.7-2.0) and 0.9 (0.2-1.7) for adherence and 6.8 (4.5-9.1) and 3.9 (1.7-6.2) for knowledge, (all p values < 0.005). In both groups the barrier score increased at T1 and decreased at T2, with a significantly larger increase at T1 and decrease at T2 in the intervention group (mean differences 3.1 (1.8-4.4) and 3.3 (0.5-6.1), respectively. A short interactive educational course with patient participation on a PT guideline on hip and knee osteoarthritis showed a small to moderate positive effect on self-reported guideline adherence and knowledge, whereas for perceived barriers an advantage was only seen on the longer term.

  19. The Value of E-Learning for the Prevention of Healthcare-Associated Infections.

    PubMed

    Labeau, Sonia O; Rello, Jordi; Dimopoulos, George; Lipman, Jeffrey; Sarikaya, Aklime; Oztürk, Candan; Vandijck, Dominique M; Vogelaers, Dirk; Vandewoude, Koenraad; Blot, Stijn I

    2016-09-01

    BACKGROUND Healthcare workers (HCWs) lack familiarity with evidence-based guidelines for the prevention of healthcare-associated infections (HAIs). There is good evidence that effective educational interventions help to facilitate guideline implementation, so we investigated whether e-learning could enhance HCW knowledge of HAI prevention guidelines. METHODS We developed an electronic course (e-course) and tested its usability and content validity. An international sample of voluntary learners submitted to a pretest (T0) that determined their baseline knowledge of guidelines, and they subsequently studied the e-course. Immediately after studying the course, posttest 1 (T1) assessed the immediate learning effect. After 3 months, during which participants had no access to the course, a second posttest (T2) evaluated the residual learning effect. RESULTS A total of 3,587 HCWs representing 79 nationalities enrolled: 2,590 HCWs (72%) completed T0; 1,410 HCWs (39%) completed T1; and 1,011 HCWs (28%) completed T2. The median study time was 193 minutes (interquartile range [IQR], 96-306 minutes) The median scores were 52% (IQR, 44%-62%) for T0, 80% (IQR, 68%-88%) for T1, and 74% (IQR, 64%-84%) for T2. The immediate learning effect (T0 vs T1) was +24% (IQR, 12%-34%; P300 minutes yielded the greatest residual effect (24%). CONCLUSIONS Moderate time invested in e-learning yielded significant immediate and residual learning effects. Decision makers could consider promoting e-learning as a supporting tool in HAI prevention. Infect Control Hosp Epidemiol 2016;37:1052-1059.

  20. Diagnostic challenges of childhood asthma.

    PubMed

    Bakirtas, Arzu

    2017-01-01

    Diagnosis of asthma in childhood is challenging. Both underdiagnosis and overdiagnosis of asthma are important issues. The present review gives information about challenging factors for an accurate diagnosis of childhood asthma. Although underdiagnosis of asthma in childhood has always been the most important diagnostic problem, overdiagnosis of asthma has also been increasingly recognized. This is probably due to diagnosis of asthma based on symptoms and signs alone. Demonstration of variable airflow obstruction by lung function tests is the most common asthma diagnostic tests used in practice and is therefore strongly recommended in children who can cooperate. Recently, an asthma guideline combining the clinical and economic evidences with sensitivity and specificity of diagnostic procedures was developed to improve accuracy of diagnosis and to avoid overdiagnosis. This guideline provided an algorithmic clinical and cost-effective approach and included fractional exhaled nitric oxide measurement as one of the diagnostic tests in addition to lung function. Diagnosis of asthma in children should be made by combining relevant history with at least two confirmatory diagnostic tests whenever possible. Diagnosis based on short-period treatment trials should be limited to young children who are unable to cooperate with these tests.

  1. Cervical cancer screening among women who attend sexually transmitted diseases (STD) clinics: background paper for 2010 STD Treatment Guidelines.

    PubMed

    Datta, S Deblina; Saraiya, Mona

    2011-12-01

    In April 2008, experts reviewed updates on sexually transmitted disease (STD) prevention and treatment in preparation for the revision of the Centers for Disease Control and Prevention (CDC) STD Treatment Guidelines. This included a review of cervical cancer screening in the STD clinical setting. Key questions were identified with assistance from an expert panel. Reviews of the literature were conducted using the PubMed computerized database and shared with the panel. Updated information was incorporated in the 2010 CDC STD Treatment Guidelines. We recommend that STD clinics offering cervical screening services screen and treat women according to guidelines by the American College of Obstetrics and Gynecology, the American Cancer Society, the US Preventive Services Task Force, and the American Society for Colposcopists and Cervical Pathologists. New to the 2010 guidelines are higher age for initiating cervical screening (age ≥ 21 years) and less frequent intervals of screening (at least every 3 years). New recommendations include new technologies, such as liquid-based cytology and high-risk human papillomavirus (HPV) DNA tests. Liquid-based technologies are not recommended over conventional testing. HPV DNA tests are recommended as adjunct tests and with new indications for use in cervical screening and management. Stronger recommendations were issued for STD clinics offering cervical screening services to have protocols in place for follow-up of test results and referral (eg, colposcopy). Important additions to the 2010 STD Treatment Guidelines include information on updated algorithms for screening and management of women and recommendations for use of liquid-based cytology and high-risk HPV testing.

  2. HIV testing in dermatology - a national audit.

    PubMed

    Esson, Gavin A; Holme, S A

    2018-05-01

    Forty percent of individuals have late-stage HIV at the time of diagnosis, resulting in increased morbidity. Identifying key diseases which may indicate HIV infection can prompt clinicians to trigger testing, which may result in more timely diagnosis. The British HIV Association has published guidelines on such indicator diseases in dermatology. We audited the practice of HIV testing in UK dermatologists and General Practitioners (GPs) and compared results with the national guidelines. This audit showed that HIV testing in key indicator diseases remains below the standard set out by the national guidelines, and that GPs with special interest in dermatology have a lower likelihood for testing, and lower confidence when compared to consultants, registrars and associate specialists. Large proportions of respondents believed further training in HIV testing would be beneficial.

  3. Comprehending APA Style through Manuscript Analysis.

    ERIC Educational Resources Information Center

    Smith, Gabie E.; Eggleston, Tami J.

    2001-01-01

    Describes an activity designed to enhance undergraduate student comprehension of the American Psychological Association (APA) manual and style where students examined a poorly written paper for errors in relation to the APA guidelines. Reports the results of a study that tested the effectiveness of the activity. (CMK)

  4. 77 FR 1708 - Center for Substance Abuse Prevention; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-11

    ... Abuse Prevention (CSAP) Drug Testing Advisory Board (DTAB) will meet on January 31 and February 1, 2012... opioids as potential analytes in the Mandatory Guidelines for Federal Workplace Drug Testing Programs. The... Guidelines for Federal Workplace Drug Testing Programs. This portion of the meeting is closed to the public...

  5. Applying EALTA Guidelines as Baseline for the Foreign Language Proficiency Test in Turkey: The Case of YDS

    ERIC Educational Resources Information Center

    Kavakli, Nurdan; Arslan, Sezen

    2017-01-01

    Within the scope of educational testing and assessment, setting standards and creating guidelines as a code of practice provide more prolific and sustainable outcomes. In this sense, internationally accepted and regionally accredited principles are suggested for standardization in language testing and assessment practices. Herein, ILTA guidelines…

  6. Absence of neurovisual effects due to tissue and blood cholinesterase depression in a chronic disulfoton feeding study in dogs.

    PubMed

    Jones, R D; Hastings, T F; Landes, A M

    1999-06-01

    Technical grade disulfoton (DiSyston) was fed to Beagle dogs (four animals per sex and treatment level) at nominal concentrations of 0, 0.5, 4 and 12 ppm for 1 year. The purpose of this study was to characterize the potential general and neurovisual toxicity according to routine Environmental Protection Agency (EPA) guideline requirements, and by use of ancillary ocular and neurologic tests established in this Laboratory. Ophthalmological tests included: ocular tissue cholinesterase and histopathology, electroretinography (ERG), tracking, refractivity, intraocular pressure and pachymetry (corneal thickness) measurements. Neurological examinations included; peripheral and cranial reflex tests, task performance tests, gait and behavioral observations, and rectal temperature measurements. Plasma, erythrocyte and corneal cholinesterase were significantly depressed at 4 and 12 ppm in both sexes. Brain cholinesterase was depressed at 4 and 12 ppm in females. Retinal cholinesterase was depressed at 4 ppm in females and at 12 ppm in males. Ciliary body cholinesterase was depressed at 12 ppm in both sexes. Despite these cholinergic effects, there were no ophthalmologic findings in measurements of ERG, tracking, refractivity, intraocular pressure or pachymetry. There were no clinical neurology findings related to compound administration. We conclude that 0.5 ppm was a no-observable effect level (NOEL), and effects were limited to cholinesterase changes that had no detectable physiologic impact. This study demonstrates that special mechanistic investigations incorporated within guideline studies, enhances scientific integrity and can minimize the need for dedicated organ system studies.

  7. ICH S7B draft guideline on the non-clinical strategy for testing delayed cardiac repolarisation risk of drugs: a critical analysis.

    PubMed

    Cavero, Icilio; Crumb, William

    2005-05-01

    The International Conference on Harmonization (ICH) stems from the initiative of three major world partners (Japan, USA, European Community) who composed a mutually accepted body of regulations concerning the safety, quality and efficacy requirements that new medicines have to meet in order to receive market approval. Documents on non-clinical safety pharmacology already composed by this organisation include two guidelines: the S7A adopted in 2000 and, its companion, the S7B guideline, in a draft form since 2001. The S7A guideline deals with general principles and recommendations on safety pharmacology studies designed to protect healthy volunteers and patients from potential drug-induced adverse reactions. The S7B recommends a general non-clinical testing strategy for determining the propensity of non-cardiovascular pharmaceuticals to delay ventricular repolarisation, an effect that at times progresses into life-threatening ventricular arrhythmia. In the most recent version of this document (June 2004), the strategy proposes experimental assays and a critical examination of other pertinent information for applying an 'evidence of risk' label to a compound. Regrettably, the guideline fails to deal satisfactorily with a number of crucial issues such as scoring the evidence of risk and the clinical consequences of such scoring. However, in the latter case, the S7B relies on the new ICH guideline E14 which is currently in preparation. E14 is the clinical counterpart of the S7B guideline which states that non-clinical data are a poor predictor of drug-induced repolarisation delay in humans. The present contribution summarises and assesses salient aspects of the S7A guideline as its founding principles are also applicable to the S7B guideline. The differences in strategies proposed by the various existing drafts of the latter document are critically examined together with some unresolved, crucial problems. The need for extending the objective of the S7B document to characterise the full electrophysiological profile of new pharmaceuticals is argued as this approach would more extensively assess the non-clinical cardiac safety of a drug. Finally, in order to overcome present difficulties in arriving at the definitive version of the S7B guideline, the Expert Working Group could reflect on the introduction of the S7B guideline recommendations in the S7A document, as originally intended, or on postponing the adoption of an harmonized text until the availability of novel scientific data allows solving presently contentious aspects of this and the E14 guidelines.

  8. Basic Exploratory Research versus Guideline-Compliant Studies Used for Hazard Evaluation and Risk Assessment: Bisphenol A as a Case Study

    PubMed Central

    Tyl, Rochelle W.

    2009-01-01

    Background Myers et al. [Environ Health Perspect 117:309–315 (2009)] argued that Good Laboratory Practices (GLPs) cannot be used as a criterion for selecting data for risk assessment, using bisphenol A (BPA) as a case study. They did not discuss the role(s) of guideline-compliant studies versus basic/exploratory research studies, and they criticized both GLPs and guideline-compliant studies and their roles in formal hazard evaluation and risk assessment. They also specifically criticized our published guideline-compliant dietary studies on BPA in rats and mice and 17β-estradiol (E2) in mice. Objectives As the study director/first author of the criticized E2 and BPA studies, I discuss the uses of basic research versus guideline-compliant studies, how testing guidelines are developed and revised, how new end points are validated, and the role of GLPs. I also provide an overview of the BPA guideline-compliant and exploratory research animal studies and describe BPA pharmacokinetics in rats and humans. I present responses to specific criticisms by Myers et al. Discussion and conclusions Weight-of-evidence evaluations have consistently concluded that low-level BPA oral exposures do not adversely affect human developmental or reproductive health, and I encourage increased validation efforts for “new” end points for inclusion in guideline studies, as well as performance of robust long-term studies to follow early effects (observed in small exploratory studies) to any adverse consequences. PMID:20049112

  9. Korean guidelines for the diagnosis and management of dry eye: development and validation of clinical efficacy.

    PubMed

    Hyon, Joon Young; Kim, Hyo-Myung; Lee, Doh; Chung, Eui-Sang; Song, Jong-Suk; Choi, Chul Young; Lee, Jungbok

    2014-06-01

    To evaluate the clinical efficacy of newly developed guidelines for the diagnosis and management of dry eye. This retrospective, multi-center, non-randomized, observational study included a total of 1,612 patients with dry eye disease who initially visited the clinics from March 2010 to August 2010. Korean guidelines for the diagnosis and management of dry eye were newly developed from concise, expert-consensus recommendations. Severity levels at initial and final visits were determined using the guidelines in patients with 90 ± 7 days of follow-up visits (n = 526). Groups with different clinical outcomes were compared with respect to clinical parameters, treatment modalities, and guideline compliance. Main outcome measures were ocular and visual symptoms, ocular surface disease index, global assessment by patient and physician, tear film break-up time, Schirmer-1 test score, ocular surface staining score at initial and final visits, clinical outcome after three months of treatment, and guideline compliance. Severity level was reduced in 47.37% of patients treated as recommended by the guidelines. Younger age (odd ratio [OR], 0.984; p = 0.044), higher severity level at initial visit, compliance to treatment recommendation (OR, 1.832; p = 0.047), and use of topical cyclosporine (OR, 1.838; p = 0.011) were significantly associated with improved clinical outcomes. Korean guidelines for the diagnosis and management of dry eye can be used as a valid and effective tool for the treatment of dry eye disease.

  10. Effectiveness of reprocessing for flexible bronchoscopes and endobronchial ultrasound bronchoscopes.

    PubMed

    Ofstead, Cori L; Quick, Mariah R; Wetzler, Harry P; Eiland, John E; Heymann, Otis L; Sonetti, David A; Ferguson, J Scott

    2018-05-30

    Infections have been linked to inadequately-reprocessed flexible bronchoscopes, and recent investigations determined that pathogen transmission occurred even when bronchoscope cleaning and disinfection practices aligned with current guidelines. This multisite, prospective study evaluated the effectiveness of real-world bronchoscope reprocessing methods using a systematic approach. This study involved direct observation of reprocessing methods for flexible bronchoscopes, multifaceted evaluations performed after manual cleaning and after high-level disinfection, and assessments of storage conditions. Visual inspections of ports and channels were performed using lighted magnification and borescopes. Contamination was detected using microbial cultures and tests for protein, hemoglobin, and adenosine triphosphate. Researchers assessed reprocessing practices, and storage cabinet cleanliness was evaluated by visual inspection and adenosine triphosphate tests. Researchers examined 24 clinically used bronchoscopes. After manual cleaning, 100% of bronchoscopes had residual contamination. Microbial growth was found in 14 (58%) fully-reprocessed bronchoscopes, including mold, Stenotrophomonas maltophilia, and Escherichia coli/Shigella spp. Visible irregularities were observed in 100% of bronchoscopes, including retained fluid; brown, red, or oily residue; scratches; damaged insertion tubes and distal ends; and filamentous debris in channels. Reprocessing practices were substandard at two of three sites. Damaged and contaminated bronchoscopes were in use at all sites. Inadequate reprocessing practices may have contributed to bioburden found on bronchoscopes. However, even when guidelines were followed, high-level disinfection was not effective. A shift toward the use of sterilized bronchoscopes is recommended. In the meantime, quality management programs and updated reprocessing guidelines are needed. Copyright © 2018. Published by Elsevier Inc.

  11. Supporting Reporting: On the Positive Effects of Text- and Video-Based Awareness Material on Responsible Journalistic Suicide News Writing.

    PubMed

    Scherr, Sebastian; Arendt, Florian; Schäfer, Markus

    2017-01-01

    Suicide is a global public health problem. Media impact on suicide is well confirmed and there are several recommendations on how media should and should not report on suicide to minimize the risk of copycat behavior. Those media guidelines have been developed to improve responsible reporting on suicide (RRS). Although such guidelines are used in several countries, we lack empirical evidence on their causal effect on actual journalistic news writing. We conducted an experiment with journalism students (N = 78) in Germany in which we tested whether exposure to awareness material promoting RRS influences news writing. As a supplement to the widely used text-based material, we tested the impact of a video in which a suicide expert presents the guidelines. A video was used as a supplement to text partly due to its potential benefit for prevention efforts over the Internet. We chose a low-budget production process allowing easy reproduction in different countries by local suicide experts. In the experiment, participants were either exposed to written, audio-visual, or no awareness material. Afterwards, participants read numerous facts of an ostensible suicide event and were asked to write a factual suicide news story based on these facts. Analyses indicate that awareness material exposure helped to improve RRS with the awareness video showing the strongest effects. We recommend that suicide prevention should use instructive awareness videos about RRS complementary to text-based awareness material.

  12. Conducting a battery of bioassays for gold nanoparticles to derive guideline value for the protection of aquatic ecosystems.

    PubMed

    Nam, Sun-Hwa; Shin, Yu-Jin; Lee, Woo-Mi; Kim, Shin Woong; Kwak, Jin Il; Yoon, Sung-Ji; An, Youn-Joo

    2015-05-01

    Gold nanoparticles (Au-NPs) are used in many applications, including the manufacture of products like cosmetics, paints, and electrochemical immunosensors, and in the detection, diagnosis, and treatment of tumors. However, there are no legal or recommended guidelines for protecting aquatic ecosystems from Au-NPs. In this study, we conducted a battery of bioassays and present toxicity values for two bacteria, one alga, one euglena, three cladoceran, and two fish species that were exposed to Au-NPs. Guideline values for protecting aquatic ecosystems from Au-NPs were derived using methods that are generally used to derive water-quality guidelines and are used in Australia, New Zealand, Canada, the European Community (EC), and the USA. Au-NPs had adverse effects on all test species, including growth inhibition of both bacteria, the alga, and the euglena; mortality and immobilization in the three cladocerans; and developmental malformations in the embryos and larvae of the two fish. Guideline values of 0.15 and 0.04 × 10(10) particles/mL were derived for Au-NPs using a species sensitivity distribution (SSD) and assessment factor. The guideline value derived for Au-NPs using an assessment factor was more stringent than that derived using SSD. This is the first study to derive guideline values for nanoparticles in water environments.

  13. A hospital-site controlled intervention using audit and feedback to implement guidelines concerning inappropriate treatment of catheter-associated asymptomatic bacteriuria

    PubMed Central

    2011-01-01

    Background Catheter-associated urinary tract infection (CAUTI) is one of the most common hospital-acquired infections. However, many cases treated as hospital-acquired CAUTI are actually asymptomatic bacteriuria (ABU). Evidence-based guidelines recommend that providers neither screen for nor treat ABU in most catheterized patients, but there is a significant gap between these guidelines and clinical practice. Our objectives are (1) to evaluate the effectiveness of an audit and feedback intervention for increasing guideline-concordant care concerning catheter-associated ABU and (2) to measure improvements in healthcare providers' knowledge of and attitudes toward the practice guidelines associated with the intervention. Methods/Design The study uses a controlled pre/post design to test an intervention using audit and feedback of healthcare providers to improve their compliance with ABU guidelines. The intervention and the control sites are two VA hospitals. For objective 1 we will review medical records to measure the clinical outcomes of inappropriate screening for and treatment of catheter-associated ABU. For objective 2 we will survey providers' knowledge and attitudes. Three phases of our protocol are proposed: the first 12-month phase will involve observation of the baseline incidence of inappropriate screening for and treatment of ABU at both sites. This surveillance for clinical outcomes will continue at both sites throughout the study. Phase 2 consists of 12 months of individualized audit and feedback at the intervention site and guidelines distribution at both sites. The third phase, also over 12 months, will provide unit-level feedback at the intervention site to assess sustainability. Healthcare providers at the intervention site during phase 2 and at both sites during phase 3 will complete pre/post surveys of awareness and familiarity (knowledge), as well as of acceptance and outcome expectancy (attitudes) regarding the relevant practice guidelines. Discussion Our proposal to bring clinical practice in line with published guidelines has significant potential to decrease overdiagnosis of CAUTI and associated inappropriate antibiotic use. Our study will also provide information about how to maximize effectiveness of audit and feedback to achieve guideline adherence in the inpatient setting. Trial Registration NCT01052545 PMID:21513539

  14. A hospital-site controlled intervention using audit and feedback to implement guidelines concerning inappropriate treatment of catheter-associated asymptomatic bacteriuria.

    PubMed

    Trautner, Barbara W; Kelly, P Adam; Petersen, Nancy; Hysong, Sylvia; Kell, Harrison; Liao, Kershena S; Patterson, Jan E; Naik, Aanand D

    2011-04-22

    Catheter-associated urinary tract infection (CAUTI) is one of the most common hospital-acquired infections. However, many cases treated as hospital-acquired CAUTI are actually asymptomatic bacteriuria (ABU). Evidence-based guidelines recommend that providers neither screen for nor treat ABU in most catheterized patients, but there is a significant gap between these guidelines and clinical practice. Our objectives are (1) to evaluate the effectiveness of an audit and feedback intervention for increasing guideline-concordant care concerning catheter-associated ABU and (2) to measure improvements in healthcare providers' knowledge of and attitudes toward the practice guidelines associated with the intervention. The study uses a controlled pre/post design to test an intervention using audit and feedback of healthcare providers to improve their compliance with ABU guidelines. The intervention and the control sites are two VA hospitals. For objective 1 we will review medical records to measure the clinical outcomes of inappropriate screening for and treatment of catheter-associated ABU. For objective 2 we will survey providers' knowledge and attitudes. Three phases of our protocol are proposed: the first 12-month phase will involve observation of the baseline incidence of inappropriate screening for and treatment of ABU at both sites. This surveillance for clinical outcomes will continue at both sites throughout the study. Phase 2 consists of 12 months of individualized audit and feedback at the intervention site and guidelines distribution at both sites. The third phase, also over 12 months, will provide unit-level feedback at the intervention site to assess sustainability. Healthcare providers at the intervention site during phase 2 and at both sites during phase 3 will complete pre/post surveys of awareness and familiarity (knowledge), as well as of acceptance and outcome expectancy (attitudes) regarding the relevant practice guidelines. Our proposal to bring clinical practice in line with published guidelines has significant potential to decrease overdiagnosis of CAUTI and associated inappropriate antibiotic use. Our study will also provide information about how to maximize effectiveness of audit and feedback to achieve guideline adherence in the inpatient setting. NCT01052545.

  15. Combustion Safety for Appliances Using Indoor Air (Fact Sheet)

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

    Not Available

    2014-05-01

    This measure guideline covers how to assess and carry out the combustion safety procedures for appliances and heating equipment that uses indoor air for combustion in low-rise residential buildings. Only appliances installed in the living space, or in an area freely communicating with the living space, vented alone or in tandem with another appliance are considered here. A separate measure guideline addresses combustion appliances located either within the living space in enclosed closets or side rooms or outside the living space in an adjacent area like an attic or garage that use outdoor air for combustion. This document is formore » inspectors, auditors, and technicians working in homes where energy upgrades are being conducted whether or not air infiltration control is included in the package of measures being applied. In the indoor combustion air case, guidelines summarized here are based on language provided in several of the codes to establish minimum requirements for the space using simplified prescriptive measures. In addition, building performance testing procedures are provided by testing agencies. The codes in combination with the test procedures offer comprehensive combustion safety coverage to address safety concerns, allowing inexperienced residential energy retrofit inspectors to effectively address combustion safety issues and allow energy retrofits to proceed.« less

  16. Guidelines for the Gamification of Self-Management of Chronic Illnesses: Multimethod Study.

    PubMed

    AlMarshedi, Alaa; Wills, Gary; Ranchhod, Ashok

    2017-05-12

    Gamification is the use of game elements and techniques in nongaming contexts. The use of gamification in health care is receiving a great deal of attention in both academic research and the industry. However, it can be noticed that many gamification apps in health care do not follow any standardized guidelines. This research aims to (1) present a set of guidelines based on the validated framework the Wheel of Sukr and (2) assess the guidelines through expert interviews and focus group sessions with developers. Expert interviews (N=6) were conducted to assess the content of the guidelines and that they reflect the Wheel of Sukr. In addition, the guidelines were assessed by developers (N=15) in 5 focus group sessions, where each group had an average of 3 developers. The guidelines received support from the experts. By the end of the sixth interview, it was determined that a saturation point was reached. Experts agreed that the guidelines accurately reflect the framework the Wheel of Sukr and that developers can potentially use them to create gamified self-management apps for chronic illnesses. Moreover, the guidelines were welcomed by developers who participated in the focus group sessions. They found the guidelines to be clear, useful, and implementable. Also, they were able to suggest many ways of gamifying a nongamified self-management app when they were presented with one. The findings suggest that the guidelines introduced in this research are clear, useful, and ready to be implemented for the creation of self-management apps that use the notion of gamification as described in the Wheel of Sukr framework. The guidelines are now ready to be practically tested. Further practical studies of the effectiveness of each element in the guidelines are to be carried out. ©Alaa AlMarshedi, Gary Wills, Ashok Ranchhod. Originally published in JMIR Serious Games (http://games.jmir.org), 12.05.2017.

  17. Field evaluation of the efficacy of proprietary repellent formulations with IR3535 and picaridin against Aedes aegypti.

    PubMed

    Naucke, T J; Kröpke, R; Benner, G; Schulz, J; Wittern, K P; Rose, A; Kröckel, U; Grünewald, H W

    2007-06-01

    Seven proprietary repellent formulations (3 hydro-alcoholic spray solutions and 4 skin lotions) with active ingredient IR3,535 (ethyl butylacetylaminopropionate, EBAAP) or Picaridin (hydroxyethyl isobutyl piperidine carboxylate, KBR 3,023, Bayrepel) were tested in a field study on 10 test persons over a period of 10 h for their efficacy at preventing bites. The tests were conducted in Belo Horizonte, Brazil on field populations of the yellow fever mosquito Aedes aegypti. The concentration of the active substances ranged from 10% to 20%. All the tested samples provided lasting protection (time to first bite) over several hours: ranging from 5 h 20 min to 6 h 50 min with a mean of approximately 6 h. The longest protection until the second bite (=first confirmation bite) was approximately 7 h 40 min, whereas the shortest protection was 6 h 50 min. The longest protection until the third bite (=second confirmation bite) was 8 h 35 min, whereas the shortest protection was 7 h 40 min. In the control tests in which none of the samples were applied, the mean times until the first, second and third bites were 26, 46 and 59 min, respectively. The basis for this field study was provided by two American guidelines, which have the greatest international acceptance. The first is a draft guideline from the Environmental Protection Agency (EPA (United States Environmental Protection Agency), Product performance test guidelines. OPPTS 810.3700. Insect repellents for human skin and outdoor premises. Public Draft, 1999) and the second is a standard from the American Society for Testing and Materials (ASTM (American Society for Testing and Materials International), E 939-94 (reapproved 2,000): standard test method of field testing topical applications of compounds as repellents for medically important and pest arthropods (including insects, ticks, and mites): I. Mosquitoes, 2,000). Both guidelines recommend measuring the duration of protection until the first and second bites and also determining the relative protection efficacy in terms of a 95% protection level. The ASTM standard permits different repellents to be applied, whereas the EPA guidelines only permit the use of a single repellent (in different concentrations) on the extremities (forearms or lower leg). In the study presented here, to exclude any possibility of different repellents or concentrations of a single repellent having a reciprocal effect on each other, each test person had repellent samples applied to only one of their forearms. The other forearm was used as a control for making comparative checks every hour and for determining the biting pressure. There was no significant difference in protection times between the two active substances.

  18. The effect of requesting a reason for non-adherence to a guideline in a long running automated reminder system for PONV prophylaxis.

    PubMed

    Kooij, Fabian O; Klok, Toni; Preckel, Benedikt; Hollmann, Markus W; Kal, Jasper E

    2017-03-29

    Automated reminders are employed frequently to improve guideline adherence, but limitations of automated reminders are becoming more apparent. We studied the reasons for non-adherence in the setting of automated reminders to test the hypothesis that a separate request for a reason in itself may further improve guideline adherence. In a previously implemented automated reminder system on prophylaxis for postoperative nausea and vomiting (PONV), we included additional automated reminders requesting a reason for non-adherence. We recorded these reasons in the pre-operative screening clinic, the OR and the PACU. We compared adherence to our PONV guideline in two study groups with a historical control group. Guideline adherence on prescribing and administering PONV prophylaxis (dexamethasone and granisetron) all improved compared to the historical control group (89 vs. 82% (p< 0.0001), 96 vs 95% (not significant) and 90 vs 82% (p<0.0001)) while decreasing unwarranted prescription for PONV prophylaxis (10 vs. 13 %). In the pre-operative screening clinic, the main reason for not prescribing PONV prophylaxis was disagreement with the risk estimate by the decision support system. In the OR/PACU, the main reasons for not administering PONV prophylaxis were: 'unintended non-adherence' and 'failure to document'. In this study requesting a reason for non-adherence is associated with improved guideline adherence. The effect seems to depend on the underlying reason for non-adherence. It also illustrates the importance of human factors principles in the design of decision support. Some reasons for non-adherence may not be influenced by automated reminders.

  19. Compliance with dietary guidelines affects capillary recruitment in healthy middle-aged men and women.

    PubMed

    Govoni, Virginia; Sanders, Thomas A B; Reidlinger, Dianne P; Darzi, Julia; Berry, Sarah E E; Goff, Louise M; Seed, Paul T; Chowienczyk, Philip J; Hall, Wendy L

    2017-04-01

    Healthy microcirculation is important to maintain the health of tissues and organs, most notably the heart, kidney and retina. Single components of the diet such as salt, lipids and polyphenols may influence microcirculation, but the effects of dietary patterns that are consistent with current dietary guidelines are uncertain. It was hypothesized that compliance to UK dietary guidelines would have a favourable effect on skin capillary density/recruitment compared with a traditional British diet (control diet). A 12-week randomized controlled trial in men and women aged 40-70 years was used to test whether skin microcirculation, measured by skin video-capillaroscopy on the dorsum of the finger, influenced functional capillary density (number of capillaries perfused under basal conditions), structural capillary density (number of anatomical capillaries perfused during finger cuff inflation) and capillary recruitment (percentage difference between structural and functional capillary density). Microvascular measures were available for 137 subjects out of the 165 participants randomized to treatment. There was evidence of compliance to the dietary intervention, and participants randomized to follow dietary guidelines showed significant falls in resting supine systolic, diastolic and mean arterial pressure of 3.5, 2.6 and 2.9 mmHg compared to the control diet. There was no evidence of differences in capillary density, but capillary recruitment was 3.5 % (95 % CI 0.2, 6.9) greater (P = 0.04) on dietary guidelines compared with control. Adherence to dietary guidelines may help maintain a healthy microcirculation in middle-aged men and women. This study is registered at www.isrctn.com as ISRCTN92382106.

  20. Guidelines for European workplace drug testing in oral fluid.

    PubMed

    Cooper, Gail; Moore, Christine; George, Claire; Pichini, Simona

    2011-05-01

    Over the past decade, oral fluid has established itself as a robust testing matrix for monitoring drug use or misuse. Commercially available collection devices provide opportunities to collect and test oral fluid by the roadside and near-patient testing with both clinical and criminal justice applications. One of the main advantages of oral fluid relates to the collection of the matrix which is non-invasive, simple, and can be carried out under direct observation making it ideal for workplace drug testing. Laboratories offering legally defensible oral fluid workplace drug testing must adhere to national and international quality standards (ISO/IEC 17025); however, these standards do not address issues specific to oral fluid testing. The European Workplace Drug Testing Society (EWDTS) recognizes the importance of providing best practice guidelines to organizations offering testing and those choosing to use oral fluid drug testing to test their employees. The aim of this paper is to present the EWDTS guidelines for oral fluid workplace drug testing. Copyright © 2011 John Wiley & Sons, Ltd.

  1. Current status of accreditation for drug testing in hair.

    PubMed

    Cooper, Gail; Moeller, Manfred; Kronstrand, Robert

    2008-03-21

    At the annual meeting of the Society of Hair Testing in Vadstena, Sweden in 2006, a committee was appointed to address the issue of guidelines for hair testing and to assess the current status of accreditation amongst laboratories offering drug testing in hair. A short questionnaire was circulated amongst the membership and interested parties. Fifty-two responses were received from hair testing laboratories providing details on the amount and type of hair tests they offered and the status of accreditation within their facilities. Although the vast majority of laboratories follow current guidelines (83%), only nine laboratories were accredited to ISO/IEC 17025 for hair testing. A significant number of laboratories reporting that they were in the process of developing quality systems with a view to accrediting their methods within 2-3 years. This study provides an insight into the status of accreditation in hair testing laboratories and supports the need for guidelines to encourage best practice.

  2. Revised Bethesda Guidelines for Hereditary Nonpolyposis Colorectal Cancer (Lynch Syndrome) and Microsatellite Instability

    PubMed Central

    Umar, Asad; Boland, C. Richard; Terdiman, Jonathan P.; Syngal, Sapna; de la Chapelle, Albert; Rüschoff, Josef; Fishel, Richard; Lindor, Noralane M.; Burgart, Lawrence J.; Hamelin, Richard; Hamilton, Stanley R.; Hiatt, Robert A.; Jass, Jeremy; Lindblom, Annika; Lynch, Henry T.; Peltomaki, Païvi; Ramsey, Scott D.; Rodriguez-Bigas, Miguel A.; Vasen, Hans F. A.; Hawk, Ernest T.; Barrett, J. Carl; Freedman, Andrew N.; Srivastava, Sudhir

    2010-01-01

    Hereditary nonpolyposis colorectal cancer (HNPCC), also known as Lynch syndrome, is a common autosomal dominant syndrome characterized by early age at onset, neoplastic lesions, and microsatellite instability (MSI). Because cancers with MSI account for approximately 15% of all colorectal cancers and because of the need for a better understanding of the clinical and histologic manifestations of HNPCC, the National Cancer Institute hosted an international workshop on HNPCC in 1996, which led to the development of the Bethesda Guidelines for the identification of individuals with HNPCC who should be tested for MSI. To consider revision and improvement of the Bethesda Guidelines, another HNPCC workshop was held at the National Cancer Institute in Bethesda, MD, in 2002. In this commentary, we summarize the Workshop presentations on HNPCC and MSI testing; present the issues relating to the performance, sensitivity, and specificity of the Bethesda Guidelines; outline the revised Bethesda Guidelines for identifying individuals at risk for HNPCC; and recommend criteria for MSI testing. PMID:14970275

  3. Treatment planning constraints to avoid xerostomia in head-and-neck radiotherapy: an independent test of QUANTEC criteria using a prospectively collected dataset.

    PubMed

    Moiseenko, Vitali; Wu, Jonn; Hovan, Allan; Saleh, Ziad; Apte, Aditya; Deasy, Joseph O; Harrow, Stephen; Rabuka, Carman; Muggli, Adam; Thompson, Anna

    2012-03-01

    The severe reduction of salivary function (xerostomia) is a common complication after radiation therapy for head-and-neck cancer. Consequently, guidelines to ensure adequate function based on parotid gland tolerance dose-volume parameters have been suggested by the QUANTEC group and by Ortholan et al. We perform a validation test of these guidelines against a prospectively collected dataset and compared with a previously published dataset. Whole-mouth stimulated salivary flow data from 66 head-and-neck cancer patients treated with radiotherapy at the British Columbia Cancer Agency (BCCA) were measured, and treatment planning data were abstracted. Flow measurements were collected from 50 patients at 3 months, and 60 patients at 12-month follow-up. Previously published data from a second institution, Washington University in St. Louis (WUSTL), were used for comparison. A logistic model was used to describe the incidence of Grade 4 xerostomia as a function of the mean dose of the spared parotid gland. The rate of correctly predicting the lack of xerostomia (negative predictive value [NPV]) was computed for both the QUANTEC constraints and Ortholan et al. recommendation to constrain the total volume of both glands receiving more than 40 Gy to less than 33%. Both datasets showed a rate of xerostomia of less than 20% when the mean dose to the least-irradiated parotid gland is kept to less than 20 Gy. Logistic model parameters for the incidence of xerostomia at 12 months after therapy, based on the least-irradiated gland, were D(50) = 32.4 Gy and and γ = 0.97. NPVs for QUANTEC guideline were 94% (BCCA data), and 90% (WUSTL data). For Ortholan et al. guideline NPVs were 85% (BCCA) and 86% (WUSTL). These data confirm that the QUANTEC guideline effectively avoids xerostomia, and this is somewhat more effective than constraints on the volume receiving more than 40 Gy. Copyright © 2012 Elsevier Inc. All rights reserved.

  4. Treatment Planning Constraints to Avoid Xerostomia in Head-and-Neck Radiotherapy: An Independent Test of QUANTEC Criteria Using a Prospectively Collected Dataset

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

    Moiseenko, Vitali, E-mail: vmoiseenko@bccancer.bc.ca; Wu, Jonn; Hovan, Allan

    2012-03-01

    Purpose: The severe reduction of salivary function (xerostomia) is a common complication after radiation therapy for head-and-neck cancer. Consequently, guidelines to ensure adequate function based on parotid gland tolerance dose-volume parameters have been suggested by the QUANTEC group and by Ortholan et al. We perform a validation test of these guidelines against a prospectively collected dataset and compared with a previously published dataset. Methods and Materials: Whole-mouth stimulated salivary flow data from 66 head-and-neck cancer patients treated with radiotherapy at the British Columbia Cancer Agency (BCCA) were measured, and treatment planning data were abstracted. Flow measurements were collected from 50more » patients at 3 months, and 60 patients at 12-month follow-up. Previously published data from a second institution, Washington University in St. Louis (WUSTL), were used for comparison. A logistic model was used to describe the incidence of Grade 4 xerostomia as a function of the mean dose of the spared parotid gland. The rate of correctly predicting the lack of xerostomia (negative predictive value [NPV]) was computed for both the QUANTEC constraints and Ortholan et al. recommendation to constrain the total volume of both glands receiving more than 40 Gy to less than 33%. Results: Both datasets showed a rate of xerostomia of less than 20% when the mean dose to the least-irradiated parotid gland is kept to less than 20 Gy. Logistic model parameters for the incidence of xerostomia at 12 months after therapy, based on the least-irradiated gland, were D{sub 50} = 32.4 Gy and and {gamma} = 0.97. NPVs for QUANTEC guideline were 94% (BCCA data), and 90% (WUSTL data). For Ortholan et al. guideline NPVs were 85% (BCCA) and 86% (WUSTL). Conclusion: These data confirm that the QUANTEC guideline effectively avoids xerostomia, and this is somewhat more effective than constraints on the volume receiving more than 40 Gy.« less

  5. Treatment planning constraints to avoid xerostomia in head and neck radiotherapy: an independent test of QUANTEC criteria using a prospectively collected dataset

    PubMed Central

    Moiseenko, Vitali; Wu, Jonn; Hovan, Allan; Saleh, Ziad; Apte, Aditya; Deasy, Joseph O.; Harrow, Stephen; Rabuka, Carman; Muggli, Adam; Thompson, Anna

    2011-01-01

    Purpose The severe reduction of salivary function (xerostomia) is a common complication following radiation therapy for head and neck cancer. Consequently, guidelines to ensure adequate function based on parotid gland tolerance dose-volume parameters have been suggested by the QUANTEC group (1) and by Ortholan et al. (2). We perform a validation test of these guidelines against a prospectively collected dataset and compared to a previously published dataset. Method and Materials Whole-mouth stimulated salivary flow data from 66 head and neck cancer patients treated with radiotherapy at the British Columbia Cancer Agency (BCCA) were measured, and treatment planning data were abstracted. Flow measurements were collected from 50 patients at 3 months, and 60 patients at 12 month follow-up. Previously published data from a second institution (WUSTL) were used for comparison. A logistic model was used to describe the incidence of grade 4 xerostomia as a function of the mean dose of the spared parotid gland. The rate of correctly predicting the lack of xerostomia (negative predictive value, NPV) was computed for both the QUANTEC constraints and Ortholan et al. (2) recommendation to constrain the total volume of both glands receiving more than 40 Gy to less than 33%. Results Both data sets showed a rate of xerostomia < 20 % when the mean dose to the least-irradiated parotid gland is kept below 20 Gy. Logistic model parameters for the incidence of xerostomia at 12 months after therapy, based on the least-irradiated gland, were D50=32.4 Gy and and γ=0.97. NPVs for QUANTEC guideline were 94% (BCCA data), 90% (WUSTL data). For Ortholan et al. (2) guideline NPVs were 85% (BCCA), and 86% (WUSTL). Conclusion This confirms that the QUANTEC guideline effectively avoids xerostomia, and this is somewhat more effective than constraints on the volume receiving more than 40 Gy. PMID:21640505

  6. Guidelines for cone penetration test : performance and design

    DOT National Transportation Integrated Search

    1978-07-01

    This manual presents procedures and guidelines applicable to the use of the cone penetration test. Dr. Schmertmann prepared this manual in February 1977 and made minor additions in May 1978. It represents his interpretation of the state-of-the-art in...

  7. Repeated 28-day oral toxicity study of vinclozolin in rats based on the draft protocol for the "Enhanced OECD Test Guideline No. 407" to detect endocrine effects.

    PubMed

    Shin, Jae-Ho; Moon, Hyun Ju; Kim, Tae Sung; Kang, Il Hyun; Ki, Ho Yeon; Choi, Kwang Sik; Han, Soon Young

    2006-09-01

    We performed a 28-day repeated-dose toxicity study of vinclozolin, a widely used fungicide, based on the draft protocol of the "Enhanced OECD Test Guideline 407" (Enhanced TG407) to investigate whether vinclozolin has endocrine-mediated properties according to this assay. Seven-week-old SD rats were administered with vinclozolin daily by oral gavage at dose rates of 0, 3.125, 12.5, 50 and 200 mg/kg/day for at least 28 days. The vinclozolin-treated male rats showed a reduction of epididymis and accessory sex organ weights and an alteration of hormonal patterns. A slight prolongation of the estrous cycle and changes in the estrogen/testosterone ratio and luteinizing hormone level were observed in vinclozolin-treated female rats. Thyroxin concentrations were decreased and thyroid-stimulating hormone concentrations were increased in both sexes; however, there were no compound-related microscopic lesions in the thyroid gland or changes in the thyroid weight. The endocrine-related effects of vinclozolin could be detected by the parameters examined in the present study based on the OECD protocol, suggesting the Enhanced TG407 protocol should be a suitable screening test for the detection of endocrine-mediated effects of chemicals.

  8. Development of the larval amphibian growth and development assay: Effects of chronic 4-tert-octylphenol or 17ß-trenbolone exposure in Xenopus laevis from embryo to juvenile

    EPA Science Inventory

    The Larval Amphibian Growth and Development Assay (LAGDA) is a Tier II test guideline being developed by the US Environmental Protection Agency under the Endocrine Disruptor Screening Program. The LAGDA was designed to evaluate effects of chronic chemical exposure on growth, thy...

  9. Implementation of a guideline for pressure ulcer prevention in home care: pretest-post-test study.

    PubMed

    Paquay, Louis; Verstraete, Sabine; Wouters, Renild; Buntinx, Frank; Vanderwee, Katrien; Defloor, Tom; Van Gansbeke, Hendrik

    2010-07-01

    To investigate the effect of the implementation of a patient and family education programme for pressure ulcer prevention in an organisation for home care nursing on guideline adherence and on prevalence and severity of pressure ulcers and to examine the determining factors for the application of measures for pressure ulcer prevention. Quality improvement programmes in pressure ulcer prevention are not always successful. Implementation study using a pretest-post-test design. Data were collected in three probability samples. The first post-test data collection was held after six months, the second after 18 months. Statistical analysis was used, comparing the pretest sample and the second post-test sample. After 18 months, the proportion of subjects with adherent measures had increased from 10·4-13·9%, the proportion of subjects with non-adherent measures decreased from 45·7-36·0%, the proportion of subjects without pressure ulcer prevention increased from 43·9-50·1% (p<0·0001, Chi-square test). Sub-analysis revealed that a positive change in guideline adherence was observed principally in the group at risk. Better process-of-care indicators were associated by lower pressure ulcer prevalence and less severe skin lesions. The nurses' judgement of a patient risk status was the most important factor for applying preventive measures. Furthermore, application of pressure ulcer prevention was determined by higher age (from the age category of 70-79 years), higher dependency for the activities of daily living, higher than baseline mobility score and the presence of a pressure ulcer. Guideline adherence in pressure ulcer prevention changed significantly after implementation of the education programme. There might have been inconsistencies in the nurses' risk judgement. Quality of pressure ulcer prevention improved, but several items for improvement remain. Adaptation of risk assessment procedures is needed. © 2010 Blackwell Publishing Ltd.

  10. Testing the effects of message framing, kernel state, and exercise guideline adherence on exercise intentions and resolve.

    PubMed

    de Bruijn, Gert-Jan; Out, Kim; Rhodes, Ryan E

    2014-11-01

    To study the effects of framed messages on exercise intention and resolve. Two (type of frame: gain or loss) × 2 (type of kernel state: desirable or undesirable outcome) post-test study. Participants were recruited online and questioned about their previous exercise behaviour and their exercise risk perception. After this, they were randomly allocated to one of four messages that were different in terms of positive or negative outcomes (type of frame) and in terms of attained or avoided outcomes (type of kernel state). After reading the message, participants indicated their intention and resolve to engage in sufficient exercise. No effects were found for intention. For resolve, there was a significant interaction between type of frame, type of kernel state, and exercise adherence. Those who did not adhere to the exercise guideline and read the loss-framed message with attained outcomes reported significantly higher resolve than all other participants. This study indicates the relevance of including attained outcomes in message framing exercise interventions as well as a focus on exercise resolve. What is already known on this subject? Message framing is commonly used to increase exercise intentions and behaviour. Meta-analyses do not provide consistent support for this theory. Very little attention has been paid to resolve and message factors on framing effects. What does this study add? Framed messages have an effect on exercise resolve, but not on intention. Loss-framed messages with attained outcomes are most persuasive for those who do not adhere to exercise guidelines. Exercise framing studies should include behavioural resolve next to intention. . © 2014 The British Psychological Society.

  11. 40 CFR 798.6400 - Neuropathology.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... techniques in this guideline are designed to develop data on morphologic changes in the nervous system for... comparative metabolism of the chemical and species sensitivity to the toxic effects of the test substance, as... design of the experiment shall be provided. This shall include a short justification explaining any...

  12. 40 CFR 798.6400 - Neuropathology.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... techniques in this guideline are designed to develop data on morphologic changes in the nervous system for... comparative metabolism of the chemical and species sensitivity to the toxic effects of the test substance, as... design of the experiment shall be provided. This shall include a short justification explaining any...

  13. 40 CFR 798.6400 - Neuropathology.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... techniques in this guideline are designed to develop data on morphologic changes in the nervous system for... comparative metabolism of the chemical and species sensitivity to the toxic effects of the test substance, as... design of the experiment shall be provided. This shall include a short justification explaining any...

  14. Dynamic Physical Education for Elementary School Children.

    ERIC Educational Resources Information Center

    Dauer, Victor P.; Pangrazi, Robert P.

    This guide offers a functional, child-tested physical education program for elementary students. Chapters in the book discuss the following topics: (a) current educational and sociological trends; (b) rationale for the program; (c) guidelines for program planning; (d) organization for effective teaching; (e) basis of movement learning and…

  15. 40 CFR 798.5265 - The salmonella typhimurium reverse mutation assay.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ..., exogenous glucose 6-phosphate dehydrogenase, NADH and excess of glucose-6-phosphate. (5) Control groups—(i... (CONTINUED) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) HEALTH EFFECTS TESTING GUIDELINES Genetic Toxicity § 798... number of spontaneous revertants in an untreated and/or vehicle control culture. (2) Description. Several...

  16. 40 CFR 798.5265 - The salmonella typhimurium reverse mutation assay.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ..., exogenous glucose 6-phosphate dehydrogenase, NADH and excess of glucose-6-phosphate. (5) Control groups—(i... (CONTINUED) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) HEALTH EFFECTS TESTING GUIDELINES Genetic Toxicity § 798... number of spontaneous revertants in an untreated and/or vehicle control culture. (2) Description. Several...

  17. 40 CFR 798.5265 - The salmonella typhimurium reverse mutation assay.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ..., exogenous glucose 6-phosphate dehydrogenase, NADH and excess of glucose-6-phosphate. (5) Control groups—(i... (CONTINUED) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) HEALTH EFFECTS TESTING GUIDELINES Genetic Toxicity § 798... number of spontaneous revertants in an untreated and/or vehicle control culture. (2) Description. Several...

  18. 40 CFR 798.5265 - The salmonella typhimurium reverse mutation assay.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ..., exogenous glucose 6-phosphate dehydrogenase, NADH and excess of glucose-6-phosphate. (5) Control groups—(i... (CONTINUED) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) HEALTH EFFECTS TESTING GUIDELINES Genetic Toxicity § 798... number of spontaneous revertants in an untreated and/or vehicle control culture. (2) Description. Several...

  19. 40 CFR 798.5265 - The salmonella typhimurium reverse mutation assay.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ..., exogenous glucose 6-phosphate dehydrogenase, NADH and excess of glucose-6-phosphate. (5) Control groups—(i... (CONTINUED) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) HEALTH EFFECTS TESTING GUIDELINES Genetic Toxicity § 798... number of spontaneous revertants in an untreated and/or vehicle control culture. (2) Description. Several...

  20. Assessment of wastewater treatment plant effluent on fish reproduction utilizing the adverse outcome pathway conceptual framework

    EPA Science Inventory

    Wastewater treatment plant (WWTP) effluents are a known contributor of chemical mixture inputs into the environment. Whole effluent testing guidelines were developed to screen these complex mixtures for acute toxicity. However, efficient and cost-effective approaches for screenin...

  1. Recommendations for safety testing with the in vivo comet assay.

    PubMed

    Vasquez, Marie Z

    2012-08-30

    While the in vivo comet assay increases its role in regulatory safety testing, deliberations about the interpretation of comet data continue. Concerns can arise regarding comet assay publications with limited data from non-blind testing of positive control compounds and using protocols (e.g. dose concentrations, sample times, and tissues) known to give an expected effect. There may be a tendency towards bias when the validation or interpretation of comet assay data is based on results generated by widely accepted but non-validated assays. The greatest advantages of the comet assay are its sensitivity and its ability to detect genotoxicity in tissues and at sample times that could not previously be evaluated. Guidelines for its use and interpretation in safety testing should take these factors into account. Guidelines should be derived from objective review of data generated by blind testing of unknown compounds dosed at non-toxic concentrations and evaluated in a true safety-testing environment, where the experimental design and conclusions must be defensible. However, positive in vivo comet findings with such compounds are rarely submitted to regulatory agencies and this data is typically unavailable for publication due to its proprietary nature. To enhance the development of guidelines for safety testing with the comet assay, and with the permission of several sponsors, this paper presents and discusses relevant data from multiple GLP comet studies conducted blind, with unknown pharmaceuticals and consumer products. Based on these data and the lessons we have learned through the course of conducting these studies, I suggest significant adjustments to the current conventions, and I provide recommendations for interpreting in vivo comet assay results in situations where risk must be evaluated in the absence of carcinogenicity or clinical data. Copyright © 2012 Elsevier B.V. All rights reserved.

  2. Knowledge and Adherence to the National Guidelines for Malaria Diagnosis in Pregnancy among Health-Care Providers and Drug-Outlet Dispensers in Rural Western Kenya.

    PubMed

    Riley, Christina; Dellicour, Stephanie; Ouma, Peter; Kioko, Urbanus; Omar, Ahmeddin; Kariuki, Simon; Ng'ang'a, Zipporah; Desai, Meghna; Buff, Ann M; Gutman, Julie R

    2018-05-01

    Prompt diagnosis and effective treatment of acute malaria in pregnancy (MiP) is important for the mother and fetus; data on health-care provider adherence to diagnostic guidelines in pregnancy are limited. From September to November 2013, a cross-sectional survey was conducted in 51 health facilities and 39 drug outlets in Western Kenya. Provider knowledge of national diagnostic guidelines for uncomplicated MiP were assessed using standardized questionnaires. The use of parasitologic testing was assessed in health facilities via exit interviews with febrile women of childbearing age and in drug outlets via simulated-client scenarios, posing as pregnant women or their spouses. Overall, 93% of providers tested for malaria or accurately described signs and symptoms consistent with clinical malaria. Malaria was parasitologically confirmed in 77% of all patients presenting with febrile illness at health facilities and 5% of simulated clients at drug outlets. Parasitological testing was available in 80% of health facilities; 92% of patients evaluated at these facilities were tested. Only 23% of drug outlets had malaria rapid diagnostic tests (RDTs); at these outlets, RDTs were offered in 17% of client simulations. No differences were observed in testing rates by pregnancy trimester. The study highlights gaps among health providers in diagnostic knowledge and practice related to MiP, and the lack of malaria diagnostic capacity, particularly in drug outlets. The most important factor associated with malaria testing of pregnant women was the availability of diagnostics at the point of service. Interventions that increase the availability of malaria diagnostic services might improve malaria case management in pregnant women.

  3. Single Health System Adherence to 2012 Cervical Cancer Screening Guidelines at Extremes of Age and Posthysterectomy.

    PubMed

    Teoh, Deanna; Isaksson Vogel, Rachel; Hultman, Gretchen; Monu, Minnu; Downs, Levi; Geller, Melissa A; Le, Chap; Melton-Meaux, Genevieve; Kulasingam, Shalini

    2017-03-01

    To estimate the proportion of guideline nonadherent Pap tests in women aged younger than 21 years and older than 65 years and posthysterectomy in a single large health system. Secondary objectives were to describe temporal trends and patient and health care provider characteristics associated with screening in these groups. A retrospective cross-sectional chart review was performed at Fairview Health Services and University of Minnesota Physicians. Reasons for testing and patient and health care provider information were collected. Tests were designated as indicated or nonindicated per the 2012 cervical cancer screening guidelines. Point estimates and descriptive statistics were calculated. Patient and health care provider characteristics were compared between indicated and nonindicated groups using χ and Wilcoxon rank-sum tests. A total of 3,920 Pap tests were performed between September 9, 2012, and August 31, 2014. A total of 257 (51%; 95% confidence interval [CI] 46.1-54.9%) of tests in the younger than 21 years group, 536 (40%; 95% CI 37.7-43.1%) in the older than 65 years group, and 605 (29%; 95% CI 27.1-31.0%) in the posthysterectomy group were not indicated. White race in the older than 65 years group was the only patient characteristic associated with receipt of a nonindicated Pap test (P=.007). Health care provider characteristics associated with nonindicated Pap tests varied by screening group. Temporal trends showed a decrease in the proportion of nonindicated tests in the younger than 21 years group but an increase in the posthysterectomy group. For women aged younger than 21 years and older than 65 years and posthysterectomy, 35% of Pap tests performed in our health system were not guideline-adherent. There were no patient or health care provider characteristics associated with guideline nonadherent screening across all groups.

  4. Implementation guidelines for drug and alcohol regulations in mass transit

    DOT National Transportation Integrated Search

    2002-08-01

    These guidelines will assist transit agencies in developing drug and alcohol testing programs that comply with regulations of the Federal Transit Administration (FTA). The guidelines provide a comprehensive, up-to-date summary of the regulatory requi...

  5. Benefits, Harms, and Costs of Osteoporosis Screening in Male Veterans

    DTIC Science & Technology

    men; cost effectiveness analysis was not completed due to the overall lack of benefit of DXA testing. We conclude that current VADXA testing practices...and adherence in those meeting treatment thresholds (12 of follow-up time). Mortality was 21 lower in DXA tested men, also likely related to...VA guideline risk factors (0.91, 0.87-0.95);and high FRAX- BMI (0.90, 0.86-0.95). Total costs were slightly higher for DXA treated men than untested

  6. SP-100 flight qualification testing assessment

    NASA Technical Reports Server (NTRS)

    Jeanmougin, Nanette M.; Moore, Roger M.; Wait, David L.; Jacox, Michael G.

    1988-01-01

    The SP-100 is a compact space power system driven by a nuclear reactor that provides 100 kWe to the user at 200 VDC. The thermal energy generated by the nuclear reactor is converted into electrical energy by passive thermoelectric devices. Various options for tailoring the MIL-STD-1540B guidelines to the SP-100 nuclear power system are discussed. This study aids in selecting the appropriate qualification test program based on the cost, schedule, and test effectiveness of the various options.

  7. Effect of thermal cycling ramp rate on CSP assembly reliability

    NASA Technical Reports Server (NTRS)

    Ghaffarian, R.

    2001-01-01

    A JPL-led chip scale package consortium of enterprises recently joined together to pool in-kind resources for developing the quality and reliability of chip scale packages for a variety of projects. The experience of the consortium in building more than 150 test vehicle assemblies, single and double sided multilayer PWBs, and the environmental test results has now been published as a chip scale package guidelines document.

  8. An Agency with a Mind of Its Own: The EEOC's Guidelines on Employment Testing.

    ERIC Educational Resources Information Center

    Lyons, Phil

    1985-01-01

    Analyzes the legislative and judicial background of the Equal Employment Opportunities Commission (EEOC)'s 1978 Uniform Guidelines on Employment Selection Procedures. Argues that the guidelines' apparent objectives are at odds with those of the legislators who created the EEOC in the 1960s: the guidelines force employers to discriminate by race.…

  9. American Gastroenterological Association guidelines are inaccurate in detecting pancreatic cysts with advanced neoplasia: a clinicopathologic study of 225 patients with supporting molecular data.

    PubMed

    Singhi, Aatur D; Zeh, Herbert J; Brand, Randall E; Nikiforova, Marina N; Chennat, Jennifer S; Fasanella, Kenneth E; Khalid, Asif; Papachristou, Georgios I; Slivka, Adam; Hogg, Melissa; Lee, Kenneth K; Tsung, Allan; Zureikat, Amer H; McGrath, Kevin

    2016-06-01

    The American Gastroenterological Association (AGA) recently reported evidence-based guidelines for the management of asymptomatic neoplastic pancreatic cysts. These guidelines advocate a higher threshold for surgical resection than prior guidelines and imaging surveillance for a considerable number of patients with pancreatic cysts. The aims of this study were to assess the accuracy of the AGA guidelines in detecting advanced neoplasia and present an alternative approach to pancreatic cysts. The study population consisted of 225 patients who underwent EUS-guided FNA for pancreatic cysts between January 2014 and May 2015. For each patient, clinical findings, EUS features, cytopathology results, carcinoembryonic antigen analysis, and molecular testing of pancreatic cyst fluid were reviewed. Molecular testing included the assessment of hotspot mutations and deletions for KRAS, GNAS, VHL, TP53, PIK3CA, and PTEN. Diagnostic pathology results were available for 41 patients (18%), with 13 (6%) harboring advanced neoplasia. Among these cases, the AGA guidelines identified advanced neoplasia with 62% sensitivity, 79% specificity, 57% positive predictive value, and 82% negative predictive value. Moreover, the AGA guidelines missed 45% of intraductal papillary mucinous neoplasms with adenocarcinoma or high-grade dysplasia. For cases without confirmatory pathology, 27 of 184 patients (15%) with serous cystadenomas (SCAs) based on EUS findings and/or VHL alterations would continue magnetic resonance imaging (MRI) surveillance. In comparison, a novel algorithmic pathway using molecular testing of pancreatic cyst fluid detected advanced neoplasias with 100% sensitivity, 90% specificity, 79% positive predictive value, and 100% negative predictive value. The AGA guidelines were inaccurate in detecting pancreatic cysts with advanced neoplasia. Furthermore, because the AGA guidelines manage all neoplastic cysts similarly, patients with SCAs will continue to undergo unnecessary MRI surveillance. The results of an alternative approach with integrative molecular testing are encouraging but require further validation. Copyright © 2016 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

  10. Institutional Tuberculosis Transmission. Controlled Trial of Upper Room Ultraviolet Air Disinfection: A Basis for New Dosing Guidelines.

    PubMed

    Mphaphlele, Matsie; Dharmadhikari, Ashwin S; Jensen, Paul A; Rudnick, Stephen N; van Reenen, Tobias H; Pagano, Marcello A; Leuschner, Wilhelm; Sears, Tim A; Milonova, Sonya P; van der Walt, Martie; Stoltz, Anton C; Weyer, Karin; Nardell, Edward A

    2015-08-15

    Transmission is driving the global tuberculosis epidemic, especially in congregate settings. Worldwide, natural ventilation is the most common means of air disinfection, but it is inherently unreliable and of limited use in cold climates. Upper room germicidal ultraviolet (UV) air disinfection with air mixing has been shown to be highly effective, but improved evidence-based dosing guidelines are needed. To test the efficacy of upper room germicidal air disinfection with air mixing to reduce tuberculosis transmission under real hospital conditions, and to define the application parameters responsible as a basis for proposed new dosing guidelines. Over an exposure period of 7 months, 90 guinea pigs breathed only untreated exhaust ward air, and another 90 guinea pigs breathed only air from the same six-bed tuberculosis ward on alternate days when upper room germicidal air disinfection was turned on throughout the ward. The tuberculin skin test conversion rates (>6 mm) of the two chambers were compared. The hazard ratio for guinea pigs in the control chamber converting their skin test to positive was 4.9 (95% confidence interval, 2.8-8.6), with an efficacy of approximately 80%. Upper room germicidal UV air disinfection with air mixing was highly effective in reducing tuberculosis transmission under hospital conditions. These data support using either a total fixture output (rather than electrical or UV lamp wattage) of 15-20 mW/m(3) total room volume, or an average whole-room UV irradiance (fluence rate) of 5-7 μW/cm(2), calculated by a lighting computer-assisted design program modified for UV use.

  11. Provider Experiences With the Identification, Management, and Treatment of Co-Occurring Chronic Non-cancer Pain and Substance Use in the Safety Net

    PubMed Central

    Chang, Jamie Suki; Kushel, Margot; Miaskowski, Christine; Ceasar, Rachel; Zamora, Kara; Hurstak, Emily; Knight, Kelly R.

    2017-01-01

    Background In the US and internationally, providers have adopted guidelines on the management of prescription opioids for chronic non-cancer pain (CNCP). For “high-risk” patients with co-occurring CNCP and a history of substance use, guidelines advise providers to monitor patients using urine toxicology screening tests, develop opioid management plans, and refer patients to substance use treatment. Objective We report primary care provider experiences in the safety net interpreting and implementing guideline recommendations for patients with CNCP and substance use. Methods We interviewed primary care providers who work in the safety net (N=23) on their experiences managing CNCP and substance use. We analyzed interviews using a content analysis method. Results Providers found management plans and urine toxicology screening tests useful for informing patients about clinic expectations of opioid therapy and substance use. However, they described that guideline-based clinic policies had unintended consequences, such as raising barriers to open, honest dialogue about substance use and treatment. While substance use treatment was recommended for “high-risk” patients, providers described lack of integration with and availability of substance use treatment programs. Conclusions Our findings indicate that clinicians in the safety net found guideline-based clinic policies helpful. However, effective implementation was challenged by barriers to open dialogue about substance use and limited linkages with treatment programs. Further research is needed to examine how the context of safety net settings shapes the management and treatment of co-occurring CNCP and substance use. PMID:27754719

  12. Aquatic Animal Models – Not Just for Ecotox Anymore

    EPA Science Inventory

    A wide range of internationally harmonized toxicity test guidelines employing aquatic animal models have been established for regulatory use. For fish alone, there are over a dozen internationally harmonized toxicity test guidelines that have been, or are being, validated. To dat...

  13. DEVELOPMENTAL NEUROTOXICITY TESTING GUIDELINES: VARIABILITY IN MORPHOMETRIC ASSESSMENTS OF NEUROPATHOLOGY.

    EPA Science Inventory

    The USEPA Developmental Neurotoxicity (DNT) Study Test Guideline (OPPTS 870.6300) calls for neuropathological and morphometric assessments of rat pups on postnatal day (PND) 11 and at study termination (after PND 60). In recent discussions about conducting these studies on pesti...

  14. Quality Multiple-Choice Test Questions: Item-Writing Guidelines and an Analysis of Auditing Testbanks.

    ERIC Educational Resources Information Center

    Hansen, James D.; Dexter, Lee

    1997-01-01

    Analysis of test item banks in 10 auditing textbooks found that 75% of questions violated one or more guidelines for multiple-choice items. In comparison, 70% of a certified public accounting exam bank had no violations. (SK)

  15. 75 FR 22256 - Difenoconazole Pesticide Tolerances

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-28

    ... http://www.gpoaccess.gov/ecfr . To access the OPPTS Harmonized Test Guidelines referenced in this document electronically, please go to http://www.epa.gov/oppts and select ``Test Methods & Guidelines'' on... food as follows: i. Acute exposure. Quantitative acute dietary exposure and risk assessments are...

  16. USING SEDIMENT QUALITY GUIDELINES IN DREDGED MATERIAL ASSESSMENTS

    EPA Science Inventory

    Sediment quality guidelines (SQGs) are not formally included in the frameworks described in the Inland Testing manual and the Green Book because these frameworks are biologically based. The SQGs are often used informally, however, to help put the results of biological testing in ...

  17. Comparison of application of 2013 ACC/AHA guideline and 2011 European Society of Cardiology guideline for the management of dyslipidemias for primary prevention in a Turkish cohort.

    PubMed

    Yılmaz, Mustafa; Atar, İlyas; Hasırcı, Senem; Akyol, Kadirhan; Tekin, Abdullah; Karaçağlar, Emir; Çiftçi, Orçun; Müderrisoğlu, Haldun

    2017-02-01

    Atherosclerotic cardiovascular disease is a major global cause of death. The common approach in primary prevention of cardiovascular disease is to identify patients at high risk for cardiovascular disease. This article analyzes and compares the application of 2013 American College of Cardiology/American Heart Association (ACC/AHA) guideline and the 2011 European Society of Cardiology (ESC) guideline for the management of dyslipidemias for primary prevention in Turkish population. The study included 833 patients (482 women and 351 men). Risk scores were calculated according to both guidelines and indications for statin treatment were determined according to sex and age group. Variables are presented as mean±SD or median with interquartile range for continuous data and as proportions for categorical data. Variables were analyzed by unpaired t-test, Mann-Whitney U test, chi-square or Fischer's exact test as appropriate. The ACC/AHA would suggest statin treatment in 415 patients out of 833 (49.5%), while ESC would recommend statin for 193 patients out of 833 (23.1%)(p<0.001). Statins would be recommended for 40.4% of women and 62.6% of men for primary prevention by the ACC/AHA, while this figure was 12% for women and 38.4% for men according to the ESC guideline (p<0.001 for both). When compared to the ESC guideline, the ACC/AHA guideline suggests augmented statin treatment for primary prevention in Turkish population.

  18. Guidelines on the management of abnormal liver blood tests

    PubMed Central

    Cramb, Rob; Davison, Suzanne M; Dillon, John F; Foulerton, Mark; Godfrey, Edmund M; Hall, Richard; Harrower, Ulrike; Hudson, Mark; Langford, Andrew; Mackie, Anne; Mitchell-Thain, Robert; Sennett, Karen; Sheron, Nicholas C; Verne, Julia; Walmsley, Martine; Yeoman, Andrew

    2018-01-01

    These updated guidelines on the management of abnormal liver blood tests have been commissioned by the Clinical Services and Standards Committee (CSSC) of the British Society of Gastroenterology (BSG) under the auspices of the liver section of the BSG. The original guidelines, which this document supersedes, were written in 2000 and have undergone extensive revision by members of the Guidelines Development Group (GDG). The GDG comprises representatives from patient/carer groups (British Liver Trust, Liver4life, PBC Foundation and PSC Support), elected members of the BSG liver section (including representatives from Scotland and Wales), British Association for the Study of the Liver (BASL), Specialist Advisory Committee in Clinical Biochemistry/Royal College of Pathology and Association for Clinical Biochemistry, British Society of Paediatric Gastroenterology, Hepatology and Nutrition (BSPGHAN), Public Health England (implementation and screening), Royal College of General Practice, British Society of Gastrointestinal and Abdominal Radiologists (BSGAR) and Society of Acute Medicine. The quality of evidence and grading of recommendations was appraised using the AGREE II tool. These guidelines deal specifically with the management of abnormal liver blood tests in children and adults in both primary and secondary care under the following subheadings: (1) What constitutes an abnormal liver blood test? (2) What constitutes a standard liver blood test panel? (3) When should liver blood tests be checked? (4) Does the extent and duration of abnormal liver blood tests determine subsequent investigation? (5) Response to abnormal liver blood tests. They are not designed to deal with the management of the underlying liver disease. PMID:29122851

  19. Compliance with the Australian 24-hour movement guidelines for the early years: associations with weight status.

    PubMed

    Santos, Rute; Zhang, Zhiguang; Pereira, João R; Sousa-Sá, Eduarda; Cliff, Dylan P; Okely, Anthony D

    2017-11-20

    For effective public health and surveillance it is important to document the proportion of young children who meet the new Australian Integrated 24 h Movement Guidelines for the Early Years and how these associate with health outcomes. We aimed to (i) assess compliance with the new Integrated 24 h Movement Guidelines for the Early Years in a sample of Australian toddlers; and (ii) ascertain whether compliance with the guidelines associates with weight status. The sample comprised 202 toddlers (104 girls) aged 19.74 ± 4.07 months from the GET UP! Participants wore accelerometers (Actigraph GT3X+) for 24 h over 7 consecutive days to assess physical activity, sedentary time and sleep. Parents reported participants' screen time. Weight and height were measured and body mass index (BMI) z-scores by age and sex were calculated. Analysis of Covariance (ANCOVA) was performed to test differences in BMI z-scores between participants complying with (i) none or any individual guideline, (ii) any combination of meeting two guidelines, and (iii) those who met all three guidelines, adjusting for child age, gender and socioeconomic status. Only 8.9% of the sample met the overall 24 h movement guidelines. Most of the sample met the physical activity (96.5%) and sleep (79.7%) guidelines but only 11.4% met the sedentary behavior guideline. Average BMI Z-scores did not significantly differ between children who complied with none or any individual guideline, any combination of meeting two guidelines, and those who met all three guidelines (p > 0.05). Although the lack of significant differences, participants who accomplished any combination of two guidelines or all three guidelines appear to have had a lower BMI Z-score than those complying with one of the guidelines or none. Just under 9% of our sample met the overall Australian 24 h Movement Guidelines for the Early Years. BMI was not associated with the accomplishment of any of the 24-h Movement Guidelines. Strategies to promote adherence to the 24-h movement guidelines in toddlers, particularly for screen time, are necessary, as promoting health-related behaviors in early childhood has the potential to provide children a strong foundation for lifelong physical and mental health.

  20. Commercial grade item (CGI) dedication of generators for nuclear safety related applications

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

    Das, R.K.; Hajos, L.G.

    1993-03-01

    The number of nuclear safety related equipment suppliers and the availability of spare and replacement parts designed specifically for nuclear safety related application are shrinking rapidly. These have made it necessary for utilities to apply commercial grade spare and replacement parts in nuclear safety related applications after implementing proper acceptance and dedication process to verify that such items conform with the requirements of their use in nuclear safety related application. The general guidelines for the commercial grade item (CGI) acceptance and dedication are provided in US Nuclear Regulatory Commission (NRC) Generic Letters and Electric Power Research Institute (EPRI) Report NP-5652,more » Guideline for the Utilization of Commercial Grade Items in Nuclear Safety Related Applications. This paper presents an application of these generic guidelines for procurement, acceptance, and dedication of a commercial grade generator for use as a standby generator at Salem Generating Station Units 1 and 2. The paper identifies the critical characteristics of the generator which once verified, will provide reasonable assurance that the generator will perform its intended safety function. The paper also delineates the method of verification of the critical characteristics through tests and provide acceptance criteria for the test results. The methodology presented in this paper may be used as specific guidelines for reliable and cost effective procurement and dedication of commercial grade generators for use as standby generators at nuclear power plants.« less

  1. Estimated saving of antibiotics in pharyngitis and lower respiratory tract infections if general practitioners used rapid tests and followed guidelines.

    PubMed

    Llor, Carles; Moragas, Ana; Cots, Josep M; López-Valcárcel, Beatriz González

    General practitioners (GP) in Spain do not have access to rapid tests and adherence to guidelines is usually suboptimal. The aim of the study is to evaluate the estimated number of antibiotics that could have been saved if GPs had appropriately used these tests and had followed the guidelines. Observational study. Primary care centres from eight Autonomous Communities in Spain. GPs who had not participated in previous studies on rational use of antibiotics. GPs registered all the cases of pharyngitis and lower respiratory tract infections (LRTI) during 15 working days in 2015, by means of a 47-item audit. Actual GPs' antibiotic prescription and estimated number of antibiotics that could have been saved according to recent guidelines. A total of 126 GPs registered 1012 episodes of pharyngitis and 1928 LRTIs. Antibiotics were given or patients were referred in 497 patients with pharyngitis (49.1%) and 963 patients with LRTI (49.9%). If GPs had appropriately used rapid antigen detection tests and C-reactive protein tests and had strictly followed current guidelines, antibiotics would have been given to 7.6% and 15.1%, respectively, with an estimated saving of 420 antibiotics in patients with sore throat (estimated saving of 84.5%; 95% CI: 81.1-87.4%) and 672 antibiotics in LRTIs (estimated saving of 69.8%,95% CI: 67.1-72.5%). GP adherence to guidelines and a correct introduction of rapid tests in clinical practice in Spain could result in a considerable saving of unnecessary prescription of antibiotics in pharyngitis and LRTIs. Copyright © 2016 Elsevier España, S.L.U. All rights reserved.

  2. Guidelines for model calibration and application to flow simulation in the Death Valley regional groundwater system

    USGS Publications Warehouse

    Hill, M.C.; D'Agnese, F. A.; Faunt, C.C.

    2000-01-01

    Fourteen guidelines are described which are intended to produce calibrated groundwater models likely to represent the associated real systems more accurately than typically used methods. The 14 guidelines are discussed in the context of the calibration of a regional groundwater flow model of the Death Valley region in the southwestern United States. This groundwater flow system contains two sites of national significance from which the subsurface transport of contaminants could be or is of concern: Yucca Mountain, which is the potential site of the United States high-level nuclear-waste disposal; and the Nevada Test Site, which contains a number of underground nuclear-testing locations. This application of the guidelines demonstrates how they may be used for model calibration and evaluation, and also to direct further model development and data collection.Fourteen guidelines are described which are intended to produce calibrated groundwater models likely to represent the associated real systems more accurately than typically used methods. The 14 guidelines are discussed in the context of the calibration of a regional groundwater flow model of the Death Valley region in the southwestern United States. This groundwater flow system contains two sites of national significance from which the subsurface transport of contaminants could be or is of concern: Yucca Mountain, which is the potential site of the United States high-level nuclear-waste disposal; and the Nevada Test Site, which contains a number of underground nuclear-testing locations. This application of the guidelines demonstrates how they may be used for model calibration and evaluation, and also to direct further model development and data collection.

  3. Regional and national guideline recommendations for digital ano-rectal examination as a means for anal cancer screening in HIV positive men who have sex with men: a systematic review.

    PubMed

    Ong, Jason J; Chen, Marcus; Grulich, Andrew E; Fairley, Christopher K

    2014-08-01

    Although anal cancer is common in HIV positive men who have sex with men, few centres offer systematic screening. Regular digital ano-rectal examination (DARE) is a type of screening that has been recommended by some experts. How widely this forms part of HIV management guidelines is unclear. The protocol was registered prospectively (CRD42013005188; http://www.crd.york.ac.uk/PROSPERO/). We systematically reviewed 121 regional and national HIV guidelines and searched for guidelines from http://hivinsite.ucsf.edu/global?page=cr-00-04#SauguidelineX, PubMed and Web of Science databases up to 5th August 2013 for recommendations of DARE as a means of anal cancer screening in HIV positive MSM. Guidelines were examined in detail if they were clinical guidelines, including both prevention and treatment protocols and were in English. Guidelines were excluded if they were restricted to limited areas (e.g. antiretroviral therapy only, children or pregnant women, strategies for prevention/testing). Information was extracted regarding recommendation of DARE as a screening method, the frequency of DARE recommended, target population for screening and the strength of evidence supporting this. 30 regional and national guidelines were included and examined in detail. Only 2 recommended DARE. The 'European AIDS Clinical Society Guidelines' recommends DARE every 1-3 years for HIV positive MSM whilst the 'US Guideline for prevention and treatment of opportunistic infections in HIV-infected adults and adolescents' recommends an annual DARE for the HIV + population in general. None of these guidelines specify the age of commencing screening. In each case, the highest level of evidence supporting these two recommendations was expert opinion. Few HIV guidelines discuss or recommend DARE as a means of anal cancer screening. Studies of the efficacy, acceptability and cost-effectiveness of DARE are needed to assess its role in anal cancer screening.

  4. Effects of test design and temperature in a partial life-cycle study with the freshwater gastropod Potamopyrgus antipodarum.

    PubMed

    Macken, Ailbhe; Le Page, Gareth; Hayfield, Amanda; Williams, Timothy D; Brown, Rebecca J

    2012-09-01

    Potamopyrgus antipodarum is a candidate for a standardized mollusk partial life-cycle study. This is a comparative study of two test designs (microplate and beaker), with additional endpoints to the proposed guideline methods, for example, tracking of continuous reproductive output over 28 d and attributing it to individual female snails. In addition, an investigation of the effects of temperature (16, 20, and 25°C) on reproduction was also conducted employing the microplate design. Copyright © 2012 SETAC.

  5. Development of partial life-cycle experiments to assess the effects of endocrine disruptors on the freshwater gastropod Lymnaea stagnalis: a case-study with vinclozolin.

    PubMed

    Ducrot, Virginie; Teixeira-Alves, Mickaël; Lopes, Christelle; Delignette-Muller, Marie-Laure; Charles, Sandrine; Lagadic, Laurent

    2010-10-01

    Long-term effects of endocrine disruptors (EDs) on aquatic invertebrates remain difficult to assess, mainly due to the lack of appropriate sensitive toxicity test methods and relevant data analysis procedures. This study aimed at identifying windows of sensitivity to EDs along the life-cycle of the freshwater snail Lymnaea stagnalis, a candidate species for the development of forthcoming test guidelines. Juveniles, sub-adults, young adults and adults were exposed for 21 days to the fungicide vinclozolin (VZ). Survival, growth, onset of reproduction, fertility and fecundity were monitored weekly. Data were analyzed using standard statistical analysis procedures and mixed-effect models. No deleterious effect on survival and growth occurred in snails exposed to VZ at environmentally relevant concentrations. A significant impairment of the male function occurred in young adults, leading to infertility at concentrations exceeding 0.025 μg/L. Furthermore, fecundity was impaired in adults exposed to concentrations exceeding 25 μg/L. Biological responses depended on VZ concentration, exposure duration and on their interaction, leading to complex response patterns. The use of a standard statistical approach to analyze those data led to underestimation of VZ effects on reproduction, whereas effects could reliably be analyzed by mixed-effect models. L. stagnalis may be among the most sensitive invertebrate species to VZ, a 21-day reproduction test allowing the detection of deleterious effects at environmentally relevant concentrations of the fungicide. These results thus reinforce the relevance of L. stagnalis as a good candidate species for the development of guidelines devoted to the risk assessment of EDs.

  6. Evaluating compliance with institutional preoperative testing guidelines for minimal-risk patients undergoing elective surgery.

    PubMed

    Siriussawakul, Arunotai; Nimmannit, Akarin; Rattana-arpa, Sirirat; Chatrattanakulchai, Siritda; Saengtawan, Puttachard; Wangdee, Aungsumat

    2013-01-01

    Few investigations preoperatively are important for low-risk patients. This study was designed to determine the level of compliance with preoperative investigation guidelines for ASA I patients undergoing elective surgery. Secondary objectives included the following: to identify common inappropriate investigations, to evaluate the impact of abnormal testing on patient management, to determine factors affecting noncompliant tests, and to estimate unnecessary expenditure. This retrospective study was conducted on adult patients over a one-year period. The institute's guidelines recommend tests according to the patients' age groups: a complete blood count (CBC) for those patients aged 18-45; CBC, chest radiograph (CXR) and electrocardiography (ECG) for those aged 46-60; and CBC, CXR, ECG, electrolytes, blood glucose, blood urea nitrogen (BUN), and creatinine (Cr) for patients aged 61-65. The medical records of 1,496 patients were reviewed. Compliant testing was found in only 12.1% (95% CI, 10.5-13.9). BUN and Cr testings were the most frequently overprescribed tests. Overinvestigations tended to be performed on major surgery and younger patients. Overall, overinvestigation incurred an estimated cost of US 200,000 dollars during the study period. The need to utilize the institution's preoperative guidelines should be emphasized in order to decrease unnecessary testing and the consequential financial burden.

  7. Use of the Coronary Artery Calcium Score in Discussion of Initiation of Statin Therapy in Primary Prevention.

    PubMed

    Michos, Erin D; Blaha, Michael J; Blumenthal, Roger S

    2017-12-01

    Clinical guidelines for instituting pharmacotherapy for the primary prevention of atherosclerotic cardiovascular disease (ASCVD), specifically lipid management and aspirin, have long been based on absolute risk. However, lipid management in the current era remains challenging to both patients and clinicians in the setting of somewhat discordant recommendations from various organizations. All guidelines endorse the use of statins for primary prevention for those at sufficient absolute risk, and treatment recommendations are generally "risk-based" rather than exclusively targeting specific low-density lipoprotein cholesterol levels. Nonetheless, guidelines differ in relation to the risk threshold for initiation and the intensity of statin treatment. The key concept of the clinician-patient risk discussion introduced in the 2013 American College of Cardiology/American Heart Association cholesterol guidelines is a process that addresses the potential for ASCVD risk reduction with statin treatment, potential for adverse treatment effects, patient preferences, encouragement of heart-healthy lifestyle, and management of other risk factors. However, operationalizing the clinician-patient risk discussion requires effective communication of the most accurate and personalized risk information. In this article, we review our treatment approach for the appropriate use of coronary artery calcium testing in the intermediate-risk patient to guide shared decision making. The decision to initiate or intensify statin therapy may be uncertain across a broad range of estimated 10-year ASCVD risk of 5% to 20%, and coronary artery calcium testing can reclassify risk upward or downward in approximately 50% of this group to inform the risk discussion. We conclude with 2 case-based examples of uncertain risk and uncertain statin therapeutic benefit to illustrate execution of the clinician-patient risk discussion. Copyright © 2017 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.

  8. Efficient clinical evaluation of guideline quality: development and testing of a new tool

    PubMed Central

    2014-01-01

    Background Evaluating the methodological quality of clinical practice guidelines is essential before deciding which ones which could best inform policy or practice. One current method of evaluating clinical guideline quality is the research-focused AGREE II instrument. This uses 23 questions scored 1–7, arranged in six domains, which requires at least two independent testers, and uses a formulaic weighted domain scoring system. Following feedback from time-poor clinicians, policy-makers and managers that this instrument did not suit clinical need, we developed and tested a simpler, shorter, binary scored instrument (the iCAHE Guideline Quality Checklist) designed for single users. Methods Content and construct validity, inter-tester reliability and clinical utility were tested by comparing the new iCAHE Guideline Quality Checklist with the AGREE II instrument. Firstly the questions and domains in both instruments were compared. Six randomly-selected guidelines on a similar theme were then assessed by three independent testers with different experience in guideline quality assessment, using both instruments. Per guideline, weighted domain and total AGREE II scores were calculated, using the scoring rubric for three testers. Total iCAHE scores were calculated per guideline, per tester. The linear relationship between iCAHE and AGREE II scores was assessed using Pearson r correlation coefficients. Score differences between testers were assessed for the iCAHE Guideline Quality Checklist. Results There were congruent questions in each instrument in four domains (Scope & Purpose, Stakeholder involvement, Underlying evidence/Rigour, Clarity). The iCAHE and AGREE II scores were moderate to strongly correlated for the six guidelines. There was generally good agreement between testers for iCAHE scores, irrespective of their experience. The iCAHE instrument was preferred by all testers, and took significantly less time to administer than the AGREE II instrument. However, the use of only three testers and six guidelines compromised study power, rendering this research as pilot investigations of the psychometric properties of the iCAHE instrument. Conclusion The iCAHE Guideline Quality Checklist has promising psychometric properties and clinical utility. PMID:24885893

  9. Assessment of learning, memory and attention in developmental neurotoxicity regulatory studies: Introduction.

    PubMed

    Makris, Susan L; Vorhees, Charles V

    2015-01-01

    There are a variety of chemicals, including pharmaceuticals, that alter neurobehavior following developmental exposure and guidelines for the conduct of studies to detect such effects by statute in the United States and Europe. Guidelines for Developmental Neurotoxicity Testing (DNT) studies issued by the U.S. Environmental Protection Agency (EPA) under prevailing law and European Organization for Economic Cooperation and Development (OECD) recommendations to member countries provide that such studies include a series of neurobehavioral and neuropathological assessments. Among these are assessment of cognitive function, specifically learning and memory. After reviewing 69 DNT studies submitted to the EPA, tests of learning and memory were noted to have detected the lowest observed adverse effect level (LOAELs) less frequently than behavioral tests of locomotor activity and acoustic/auditory startle, but slightly more than for the developmental Functional Observational Battery (devFOB; which is less extensive than the full FOB), but the reasons for the lower LOAEL detection rate for learning and memory assessment could not be determined. A major concern identified in the review, however, was the adequacy of the methods employed in these studies rather than on the importance of learning and memory to the proper assessment of brain function. Accordingly, a symposium was conducted to consider how the guidelines for tests of learning and memory might be improved. Four laboratories with established histories investigating the effects of chemical exposures during development on learning, memory, and attention, were invited to review the topic and offer recommendations, both theoretical and practical, on approaches to improve the assessment of these vital CNS functions. Reviewers were asked to recommend methods that are grounded in functional importance to CNS integrity, well-validated, reliable, and amenable to the context of regulatory studies as well as to basic research on the underlying processes they measure. This Introduction sets the stage for the reviews by providing the background and regulatory context for improved tests for learning and memory in DNT and other regulatory studies, such as single- or multi-generational studies where similar methods are incorporated. Copyright © 2015 Elsevier Inc. All rights reserved.

  10. Interventions for investigating and identifying the causes of stillbirth.

    PubMed

    Wojcieszek, Aleena M; Shepherd, Emily; Middleton, Philippa; Gardener, Glenn; Ellwood, David A; McClure, Elizabeth M; Gold, Katherine J; Khong, Teck Yee; Silver, Robert M; Erwich, Jan Jaap Hm; Flenady, Vicki

    2018-04-30

    Identification of the causes of stillbirth is critical to the primary prevention of stillbirth and to the provision of optimal care in subsequent pregnancies. A wide variety of investigations are available, but there is currently no consensus on the optimal approach. Given their cost and potential to add further emotional burden to parents, there is a need to systematically assess the effect of these interventions on outcomes for parents, including psychosocial outcomes, economic costs, and on rates of diagnosis of the causes of stillbirth. To assess the effect of different tests, protocols or guidelines for investigating and identifying the causes of stillbirth on outcomes for parents, including psychosocial outcomes, economic costs, and rates of diagnosis of the causes of stillbirth. We searched Cochrane Pregnancy and Childbirth's Trials Register (31 August 2017), ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP) (15 May 2017). We planned to include randomised controlled trials (RCTs), quasi-RCTs, and cluster-RCTs. We planned to include studies published as abstract only, provided there was sufficient information to allow us to assess study eligibility. We planned to exclude cross-over trials.Participants included parents (including mothers, fathers, and partners) who had experienced a stillbirth of 20 weeks' gestation or greater.This review focused on interventions for investigating and identifying the causes of stillbirth. Such interventions are likely to be diverse, but could include:* review of maternal and family history, and current pregnancy and birth history;* clinical history of present illness;* maternal investigations (such as ultrasound, amniocentesis, antibody screening, etc.);* examination of the stillborn baby (including full autopsy, partial autopsy or noninvasive components, such as magnetic resonance imaging (MRI), computerised tomography (CT) scanning, and radiography);* umbilical cord examination;* placental examination including histopathology (microscopic examination of placental tissue); and* verbal autopsy (interviews with care providers and support people to ascertain causes, without examination of the baby).We planned to include trials assessing any test, protocol or guideline (or combinations of tests/protocols/guidelines) for investigating the causes of stillbirth, compared with the absence of a test, protocol or guideline, or usual care (further details are presented in the Background, see Description of the intervention).We also planned to include trials comparing any test, protocol or guideline (or combinations of tests/protocols/guidelines) for investigating the causes of stillbirth with another, for example, the use of a limited investigation protocol compared with a comprehensive investigation protocol. Two review authors assessed trial eligibility independently. We excluded five studies that were not RCTs. There were no eligible trials for inclusion in this review. There is currently a lack of RCT evidence regarding the effectiveness of interventions for investigating and identifying the causes of stillbirth. Seeking to determine the causes of stillbirth is an essential component of quality maternity care, but it remains unclear what impact these interventions have on the psychosocial outcomes of parents and families, the rates of diagnosis of the causes of stillbirth, and the care and management of subsequent pregnancies following stillbirth. Due to the absence of trials, this review is unable to inform clinical practice regarding the investigation of stillbirths, and the specific investigations that would determine the causes.Future RCTs addressing this research question would be beneficial, but the settings in which the trials take place, and their design, need to be given careful consideration. Trials need to be conducted with the utmost care and consideration for the needs, concerns, and values of parents and families. Assessment of longer-term psychosocial variables, economic costs to health services, and effects on subsequent pregnancy care and outcomes should also be considered in any future trials.

  11. Guidance for Classifying Studies Conducted Using the OECD Test Guideline 223 (TG223) (Acute Avian Oral Sequential Dose Study)

    EPA Pesticide Factsheets

    Guidance based on comparison of results from the TG223 validation studies to results from avian acute oral studies previously submitted to EPA for two test chemicals following EPA's 850.2100 (public draft) guidelines.

  12. 75 FR 29908 - Prothioconazole; Pesticide Tolerances

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-28

    ....gpoaccess.gov/ecfr . To access the harmonized test guidelines referenced in this document electronically, please go http://www.epa.gov/ocspp and select ``Test Methods and Guidelines.'' C. Can I File an Objection... dietary exposures and all other exposures for which there is reliable information.'' This includes...

  13. Molecular Biomarkers for the Evaluation of Colorectal Cancer: Guideline From the American Society for Clinical Pathology, College of American Pathologists, Association for Molecular Pathology, and American Society of Clinical Oncology.

    PubMed

    Sepulveda, Antonia R; Hamilton, Stanley R; Allegra, Carmen J; Grody, Wayne; Cushman-Vokoun, Allison M; Funkhouser, William K; Kopetz, Scott E; Lieu, Christopher; Lindor, Noralane M; Minsky, Bruce D; Monzon, Federico A; Sargent, Daniel J; Singh, Veena M; Willis, Joseph; Clark, Jennifer; Colasacco, Carol; Bryan Rumble, R; Temple-Smolkin, Robyn; B Ventura, Christina; Nowak, Jan A

    2017-05-01

    - To develop evidence-based guideline recommendations through a systematic review of the literature to establish standard molecular biomarker testing of colorectal cancer (CRC) tissues to guide epidermal growth factor receptor (EGFR) therapies and conventional chemotherapy regimens. - The American Society for Clinical Pathology, College of American Pathologists, Association for Molecular Pathology, and American Society of Clinical Oncology convened an expert panel to develop an evidence-based guideline to establish standard molecular biomarker testing and guide therapies for patients with CRC. A comprehensive literature search that included more than 4,000 articles was conducted. - Twenty-one guideline statements were established. - Evidence supports mutational testing for EGFR signaling pathway genes, since they provide clinically actionable information as negative predictors of benefit to anti-EGFR monoclonal antibody therapies for targeted therapy of CRC. Mutations in several of the biomarkers have clear prognostic value. Laboratory approaches to operationalize CRC molecular testing are presented.

  14. Exercise Blood Pressure Guidelines: Time to Re-evaluate What is Normal and Exaggerated?

    PubMed

    Currie, Katharine D; Floras, John S; La Gerche, Andre; Goodman, Jack M

    2018-03-24

    Blood pressure responses to graded exercise testing can provide important diagnostic and prognostic information. While published guidelines outline what constitutes a "normal" and "abnormal" (i.e., exaggerated) blood pressure response to exercise testing, the widespread use of exaggerated blood pressure responses as a clinical tool is limited due to sparse and inconsistent data. A review of the original sources from these guidelines reveals an overall lack of empirical evidence to support both the normal blood pressure responses and their upper limits. In this current opinion, we critically evaluate the current exercise blood pressure guidelines including (1) the normal blood pressure responses to graded exercise testing; (2) the upper limits of this normal response; (3) the blood pressure criteria for test termination; and (4) the thresholds for exaggerated blood pressure responses. We provide evidence that exercise blood pressure responses vary according to subject characteristics, and subsequently a re-evaluation of what constitutes normal and abnormal responses is necessary to strengthen the clinical utility of this assessment.

  15. Update on US EPA's Revision to the 1985 Guidelines for ...

    EPA Pesticide Factsheets

    National Water Quality Criteria for the Protection of Aquatic Organisms and Their Uses (Stephan et al. 1985), to reflect the current state-of-the-science for aquatic effects assessments. Following a 2015 public meeting soliciting early input from the scientific community, EPA decided to undertake two overarching parallel tracks for this revision: 1) updating and refining methods for deriving state-of-the-science criteria through comprehensive analyses, and 2) developing criteria more rapidly for the broader protection of aquatic life from the potential adverse effects of the large number of chemicals released into the aquatic environment. The first track reflects that for a smaller group of chemicals, criteria development may be scientifically complex, and deriving robust criteria for these chemicals may require detailed investigation. The second track reflects the recognition that extensive testing of all chemicals is infeasible and there is a need to efficiently derive criteria using approaches that estimate safe environmental concentrations with limited empirical data. Based on these objectives, EPA will develop two criteria documents for this revision: 1) a Comprehensive Guidelines Document, intended to directly update and expand upon approaches presented in the 1985 Guidelines, and that will describe methods that provide criteria for chemicals requiring a more detailed level of evaluation, and 2) an Expedited Guidelines Document, which will focus on criteri

  16. Sealed-cell nickel-cadmium battery applications manual

    NASA Technical Reports Server (NTRS)

    Scott, W. R.; Rusta, D. W.

    1979-01-01

    The design, procurement, testing, and application of aerospace quality, hermetically sealed nickel-cadmium cells and batteries are presented. Cell technology, cell and battery development, and spacecraft applications are emphasized. Long term performance is discussed in terms of the effect of initial design, process, and application variables. Design guidelines and practices are given.

  17. 40 CFR 798.5300 - Detection of gene mutations in somatic cells in culture.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    .... (5) Control groups. Positive and negative (untreated and/or vehicle) controls shall be included in.... Data shall be presented in tabular form. Individual colony counts for the treated and control groups... (CONTINUED) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) HEALTH EFFECTS TESTING GUIDELINES Genetic Toxicity § 798...

  18. 40 CFR 798.5300 - Detection of gene mutations in somatic cells in culture.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    .... (5) Control groups. Positive and negative (untreated and/or vehicle) controls shall be included in.... Data shall be presented in tabular form. Individual colony counts for the treated and control groups... (CONTINUED) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) HEALTH EFFECTS TESTING GUIDELINES Genetic Toxicity § 798...

  19. 40 CFR 798.5300 - Detection of gene mutations in somatic cells in culture.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    .... (5) Control groups. Positive and negative (untreated and/or vehicle) controls shall be included in.... Data shall be presented in tabular form. Individual colony counts for the treated and control groups... (CONTINUED) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) HEALTH EFFECTS TESTING GUIDELINES Genetic Toxicity § 798...

  20. 40 CFR 798.5300 - Detection of gene mutations in somatic cells in culture.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    .... (5) Control groups. Positive and negative (untreated and/or vehicle) controls shall be included in.... Data shall be presented in tabular form. Individual colony counts for the treated and control groups... (CONTINUED) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) HEALTH EFFECTS TESTING GUIDELINES Genetic Toxicity § 798...

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