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Sample records for omeract validation criteria

  1. Testing of the OMERACT 8 draft validation criteria for a soluble biomarker reflecting structural damage in rheumatoid arthritis: a systematic literature search on 5 candidate biomarkers

    Syversen, Silje W; Landewe, Robert; van der Heijde, Désirée

    2009-01-01

    OBJECTIVE: To test the OMERACT 8 draft validation criteria for soluble biomarkers by assessing the strength of literature evidence in support of 5 candidate biomarkers. METHODS: A systematic literature search was conducted on the 5 soluble biomarkers RANKL, osteoprotegerin (OPG), matrix...... metalloprotease (MMP-3), urine C-telopeptide of types I and II collagen (U-CTX-I and U CTX-II), focusing on the 14 OMERACT 8 criteria. Two electronic voting exercises were conducted to address: (1) strength of evidence for each biomarker as reflecting structural damage according to each individual criterion...

  2. Updating the OMERACT filter

    Tugwell, Peter; Boers, Maarten; D'Agostino, Maria-Antonietta

    2014-01-01

    OBJECTIVE: The Outcome Measures in Rheumatology (OMERACT) Filter provides guidelines for the development and validation of outcome measures for use in clinical research. The "Truth" section of the OMERACT Filter requires that criteria be met to demonstrate that the outcome instrument meets...... the criteria for content, face, and construct validity. METHODS: Discussion groups critically reviewed a variety of ways in which case studies of current OMERACT Working Groups complied with the Truth component of the Filter and what issues remained to be resolved. RESULTS: The case studies showed...... that there is broad agreement on criteria for meeting the Truth criteria through demonstration of content, face, and construct validity; however, several issues were identified that the Filter Working Group will need to address. CONCLUSION: These issues will require resolution to reach consensus on how Truth...

  3. Reappraisal of OMERACT 8 draft validation criteria for a soluble biomarker reflecting structural damage endpoints in rheumatoid arthritis, psoriatic arthritis, and spondyloarthritis

    Maksymowych, Walter P; Landewé, Robert; Tak, Paul-Peter

    2009-01-01

    3, CTX-II, RANKL, OPG, CTX-I) followed by a Delphi consensus exercise addressing the importance of individual criteria and identification of omissions in the draft set. (B) Formal debate as well as group discussion centered on the key arguments for inclusion/exclusion of specific criteria. (C...

  4. Ultrasound as an Outcome Measure in Gout. A Validation Process by the OMERACT Ultrasound Working Group

    Terslev, Lene; Gutierrez, Marwin; Schmidt, Wolfgang A

    2015-01-01

    OBJECTIVE: To summarize the work performed by the Outcome Measures in Rheumatology (OMERACT) Ultrasound (US) Working Group on the validation of US as a potential outcome measure in gout. METHODS: Based on the lack of definitions, highlighted in a recent literature review on US as an outcome tool...

  5. Testing of the preliminary OMERACT validation criteria for a biomarker to be regarded as reflecting structural damage endpoints in rheumatoid arthritis clinical trials: the example of C-reactive protein

    Keeling, Stephanie O; Landewe, Robert; van der Heijde, Desiree

    2007-01-01

    OBJECTIVE: A list of 14 criteria for guiding the validation of a soluble biomarker as reflecting structural damage endpoints in rheumatoid arthritis (RA) clinical trials was drafted by an international working group after a Delphi consensus exercise. C-reactive protein (CRP), a soluble biomarker...... of individual criteria in the draft set. METHODS: A systematic literature review was conducted to elicit evidence in support of each specific criterion composing the 14-criteria draft set. A summary of the key literature findings per criterion was presented to both the working group and to participants...

  6. Testing of the preliminary OMERACT validation criteria for a biomarker to be regarded as reflecting structural damage endpoints in rheumatoid arthritis clinical trials: the example of C-reactive protein

    Keeling, Stephanie O.; Landewe, Robert; van der Heijde, Desiree; Bathon, Joan; Boers, Maarten; Garnero, Patrick; Geusens, Piet; El-Gabalawy, Hani; Inman, Robert D.; Kraus, Virginia B.; Kvien, Tore K.; Mease, Philip J.; Ostergaard, Mikkel; Ritchlin, Chris; Syversen, Silje W.; Maksymowych, Walter P.

    2007-01-01

    A list of 14 criteria for guiding the validation of a soluble biomarker as reflecting structural damage endpoints in rheumatoid arthritis (RA) clinical trials was drafted by an international working group after a Delphi consensus exercise. C-reactive protein (CRP), a soluble biomarker extensively

  7. Exploration, Development, and Validation of Patient-reported Outcomes in Antineutrophil Cytoplasmic Antibody–associated Vasculitis Using the OMERACT Process

    Robson, Joanna C.; Milman, Nataliya; Tomasson, Gunnar; Dawson, Jill; Cronholm, Peter F.; Kellom, Katherine; Shea, Judy; Ashdown, Susan; Boers, Maarten; Boonen, Annelies; Casey, George C.; Farrar, John T.; Gebhart, Don; Krischer, Jeffrey; Lanier, Georgia; McAlear, Carol A.; Peck, Jacqueline; Sreih, Antoine G.; Tugwell, Peter; Luqmani, Raashid A.; Merkel, Peter A.

    2016-01-01

    Objective Antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) is a group of linked multisystem life- and organ-threatening diseases. The Outcome Measures in Rheumatology (OMERACT) vasculitis working group has been at the forefront of outcome development in the field and has achieved OMERACT endorsement of a core set of outcomes for AAV. Patients with AAV report as important some manifestations of disease not routinely collected through physician-completed outcome tools; and they rate common manifestations differently from investigators. The core set includes the domain of patient-reported outcomes (PRO). However, PRO currently used in clinical trials of AAV do not fully characterize patients’ perspectives on their burden of disease. The OMERACT vasculitis working group is addressing the unmet needs for PRO in AAV. Methods Current activities of the working group include (1) evaluating the feasibility and construct validity of instruments within the PROMIS (Patient-Reported Outcome Measurement Information System) to record components of the disease experience among patients with AAV; (2) creating a disease-specific PRO measure for AAV; and (3) applying The International Classification of Functioning, Disability and Health to examine the scope of outcome measures used in AAV. Results The working group has developed a comprehensive research strategy, organized an investigative team, included patient research partners, obtained peer-reviewed funding, and is using a considerable research infrastructure to complete these interrelated projects to develop evidence-based validated outcome instruments that meet the OMERACT filter of truth, discrimination, and feasibility. Conclusion The OMERACT vasculitis working group is on schedule to achieve its goals of developing validated PRO for use in clinical trials of AAV. (First Release September 1 2015; J Rheumatol 2015;42:2204–9; doi:10.3899/jrheum.141143) PMID:26329344

  8. Testing of the preliminary OMERACT validation criteria for a biomarker to be regarded as reflecting structural damage endpoints in rheumatoid arthritis clinical trials: the example of C-reactive protein

    Keeling, Stephanie O; Landewe, Robert; van der Heijde, Desiree

    2007-01-01

    -based survey. RESULTS: Minimal data were extracted from the literature pertaining to those criteria listed under the category of truth. Ratings for strength of evidence were moderate to low (... under the category of truth. CONCLUSION: The draft criteria serve as a useful template in the evaluation of the strength of evidence in support of a particular soluble biomarker as reflecting structural damage in RA....

  9. A systematic literature review of US definitions, scoring systems and validity according to the OMERACT filter for tendon lesion in RA and other inflammatory joint diseases.

    Alcalde, María; D'Agostino, Maria Antonietta; Bruyn, George A W; Möller, Ingrid; Iagnocco, Annamaria; Wakefield, Richard J; Naredo, Esperanza

    2012-07-01

    To present the published data concerning the US assessment of tendon lesions as well as the US metric properties investigated in inflammatory arthritis. A systematic literature search of PubMed, Embase and the Cochrane Library was performed. Selection criteria were original articles in the English language reporting US, Doppler, tenosynovitis and other tendon lesions in patients with RA and other inflammatory arthritis. Data extraction focused on the definition and quantification of US-detected tenosynovitis and other tendon abnormalities and the metric properties of US according to the OMERACT filter for evaluating the above tendon lesions. Thirty-three of 192 identified articles were included in the review. Most articles were case series (42%) or case-control (33%) studies describing hand and/or foot tenosynovitis in RA patients. The majority of older articles used only B-mode, whereas the most recent studies have incorporated Doppler mode. Definition of tenosynovitis or other tendon lesion was provided in 70% of the evaluated studies. Most of the studies (61%) used a binary score for evaluating tendon abnormalities. Concerning the OMERACT filter, 24 (73%) articles dealt with construct validity. The comparator most commonly used was clinical assessment and MRI. There were few studies assessing criterion validity. Some studies evaluated reliability (36%), responsiveness (21%) and feasibility (12%). US seems a promising tool for evaluating inflammatory tendon lesions. However, further validation is necessary for implementation in clinical practice and trials.

  10. Updating the OMERACT filter

    D'Agostino, Maria-Antonietta; Boers, Maarten; Kirwan, John

    2014-01-01

    OBJECTIVE: The Outcome Measures in Rheumatology (OMERACT) Filter provides a framework for the validation of outcome measures for use in rheumatology clinical research. However, imaging and biochemical measures may face additional validation challenges because of their technical nature. The Imaging...... using the original OMERACT Filter and the newly proposed structure. Breakout groups critically reviewed the extent to which the candidate biomarkers complied with the proposed stepwise approach, as a way of examining the utility of the proposed 3-dimensional structure. RESULTS: Although...... was obtained for a proposed tri-axis structure to assess validation of imaging and soluble biomarkers; nevertheless, additional work is required to better evaluate its place within the OMERACT Filter 2.0....

  11. Updating the OMERACT filter

    Kirwan, John R; Boers, Maarten; Hewlett, Sarah

    2014-01-01

    OBJECTIVE: The Outcome Measures in Rheumatology (OMERACT) Filter provides guidelines for the development and validation of outcome measures for use in clinical research. The "Truth" section of the OMERACT Filter presupposes an explicit framework for identifying the relevant core outcomes...... for defining core areas of measurement ("Filter 2.0 Core Areas of Measurement") was presented at OMERACT 11 to explore areas of consensus and to consider whether already endorsed core outcome sets fit into this newly proposed framework. METHODS: Discussion groups critically reviewed the extent to which case......, presentation, and clarity of the framework were questioned. The discussion groups and subsequent feedback highlighted 20 such issues. CONCLUSION: These issues will require resolution to reach consensus on accepting the proposed Filter 2.0 framework of Core Areas as the basis for the selection of Core Outcome...

  12. The OMERACT Ultrasound Group

    Terslev, Lene; Iagnocco, Annamaria; Bruyn, George A W

    2017-01-01

    OBJECTIVE: To provide an update from the Outcome Measures in Rheumatology (OMERACT) Ultrasound Working Group on the progress for defining ultrasound (US) minimal disease activity threshold at joint level in rheumatoid arthritis (RA) and for standardization of US application in juvenile idiopathic......) and power Doppler (PD). Synovial effusion (SE) was scored a binary variable. For JIA, a Delphi approach and subsequent validation in static images and patient-based exercises were used to developed preliminary definitions for synovitis and a scoring system. RESULTS: For minimal disease activity, 7% HC had...

  13. Validation of the OMERACT Magnetic Resonance Imaging Joint Space Narrowing Score for the Wrist in a Multireader Longitudinal Trial

    Glinatsi, Daniel; Lillegraven, Siri; Haavardsholm, Espen A

    2015-01-01

    OBJECTIVE: To assess the intrareader and interreader agreement and sensitivity to change of the Outcome Measures in Rheumatology (OMERACT) Rheumatoid Arthritis Magnetic Resonance Imaging Joint Space Narrowing (RAMRIS-JSN) score in the rheumatoid arthritis (RA) wrist in a longitudinal multireader...... exercise. METHODS: Coronal T1-weighted MR image sets of 1 wrist from 20 patients with early RA were assessed twice for JSN at 17 sites at baseline and after 36 or 60 months by 4 readers blinded to patient data but not time order. The joints were scored 0-4 according to the OMERACT RAMRIS-JSN score...

  14. Content and Construct Validity, Reliability, and Responsiveness of the Rheumatoid Arthritis Flare Questionnaire: OMERACT 2016 Workshop Report

    Bartlett, S.J.; Barbic, S.P.; Bykerk, V.P.; Choy, E.H.; Alten, R.; Christensen, R.; Broeder, A. den; Fautrel, B.; Furst, D.E.; Guillemin, F.; Hewlett, S.; Leong, A.L.; Lyddiatt, A.; March, L.; Montie, P.; Pohl, C.; Voshaar, M.; Woodworth, T.G.; Bingham, C.O.

    2017-01-01

    OBJECTIVE: The Outcome Measures in Rheumatology (OMERACT) Rheumatoid Arthritis (RA) Flare Group was established to develop a reliable way to identify and measure RA flares in randomized controlled trials (RCT). Here, we summarized the development and field testing of the RA Flare Questionnaire

  15. OMERACT Rheumatoid Arthritis Magnetic Resonance Imaging Studies. Summary of OMERACT 6 MR Imaging Module

    McQueen, F; Lassere, M; Edmonds, J

    2003-01-01

    correlates closely with histological evidence and work continues on validating MR erosions with reference to radiographic techniques. The RAMRIS has demonstrated good reliability for bone erosion and synovitis at the wrists and metacarpophalangeal joints subject to reader training, with slightly lower levels......Magnetic resonance image (MRI) scanning is a new method for imaging and quantifying joint inflammation and damage in rheumatoid arthritis (RA). Over the past 4 years, the OMERACT MR Imaging Group has been developing and testing the RA-MRI scoring system (RAMRIS) for use in RA. The OMERACT filter...... and scoring, as well as cost and safety issues. The OMERACT RAMRIS provides a framework for scoring inflammation and damage in RA upon which further modifications can be built. It has been endorsed by the MRI working group and OMERACT 6 participants as useful for inclusion as an outcome measure in clinical...

  16. Validation of OMERACT preliminary rheumatoid arthritis flare domains in the NOR-DMARD study

    Lie, Elisabeth; Woodworth, Thasia G; Christensen, Robin

    2014-01-01

    '. Convergent and divergent construct validity and content validity were assessed by correlation analyses and logistic regression analysis, respectively. RESULTS: Applying the flare working definition based on patient-reported worsening, standardised mean differences (SMDs) were >0.5 for the majority...... of outcomes. The largest SMDs were observed for Pain visual analogue scale (1.30), SF-36 Bodily pain (1.24), Patient global (1.20) and morning stiffness intensity (1.17). The flare working definition based on treatment change yielded lower SMDs (

  17. Updating the OMERACT filter

    Wells, George; Beaton, Dorcas E; Tugwell, Peter

    2014-01-01

    The "Discrimination" part of the OMERACT Filter asks whether a measure discriminates between situations that are of interest. "Feasibility" in the OMERACT Filter encompasses the practical considerations of using an instrument, including its ease of use, time to complete, monetary costs......, and interpretability of the question(s) included in the instrument. Both the Discrimination and Reliability parts of the filter have been helpful but were agreed on primarily by consensus of OMERACT participants rather than through explicit evidence-based guidelines. In Filter 2.0 we wanted to improve this definition...

  18. OMERACT-based fibromyalgia symptom subgroups: an exploratory cluster analysis.

    Vincent, Ann; Hoskin, Tanya L; Whipple, Mary O; Clauw, Daniel J; Barton, Debra L; Benzo, Roberto P; Williams, David A

    2014-10-16

    The aim of this study was to identify subsets of patients with fibromyalgia with similar symptom profiles using the Outcome Measures in Rheumatology (OMERACT) core symptom domains. Female patients with a diagnosis of fibromyalgia and currently meeting fibromyalgia research survey criteria completed the Brief Pain Inventory, the 30-item Profile of Mood States, the Medical Outcomes Sleep Scale, the Multidimensional Fatigue Inventory, the Multiple Ability Self-Report Questionnaire, the Fibromyalgia Impact Questionnaire-Revised (FIQ-R) and the Short Form-36 between 1 June 2011 and 31 October 2011. Hierarchical agglomerative clustering was used to identify subgroups of patients with similar symptom profiles. To validate the results from this sample, hierarchical agglomerative clustering was repeated in an external sample of female patients with fibromyalgia with similar inclusion criteria. A total of 581 females with a mean age of 55.1 (range, 20.1 to 90.2) years were included. A four-cluster solution best fit the data, and each clustering variable differed significantly (P FIQ-R total scores (P = 0.0004)). In our study, we incorporated core OMERACT symptom domains, which allowed for clustering based on a comprehensive symptom profile. Although our exploratory cluster solution needs confirmation in a longitudinal study, this approach could provide a rationale to support the study of individualized clinical evaluation and intervention.

  19. The OMERACT ultrasound task force--status and perspectives.

    Naredo, Esperanza

    2011-09-01

    This article reports the most recent work of the Outcome Measures in Rheumatology (OMERACT) Ultrasound Task Force, and highlights the future research priorities discussed at the OMERACT 10 meeting. Results of the following studies were presented: (1) intra- and interobserver reliability of ultrasound detecting and scoring synovitis in different joints of patients with rheumatoid arthritis (RA); (2) systematic review of previous ultrasound scoring systems of synovitis in RA; (3) enthesitis systematic review and Delphi definition exercise in spondyloarthritis enthesitis; (4) enthesitis intra- and interobserver reliability exercise; and (5) Delphi definition exercise in hand osteoarthritis, and reliability exercises. Study conclusions were discussed, and a future research agenda was approved, notably further validation of an OMERACT ultrasound global synovitis score (GLOSS) in RA, emphasizing the importance of testing feasibility, predictive value, and added value over standard clinical variables. Future research areas will include validating scoring systems for enthesitis and osteoarthritis, and testing the metric qualities of ultrasound for evaluating tenosynovitis and structural damage in RA.

  20. Validation of the OMERACT Psoriatic Arthritis Magnetic Resonance Imaging Score (PsAMRIS) for the Hand and Foot in a Randomized Placebo-controlled Trial.

    Glinatsi, Daniel; Bird, Paul; Gandjbakhch, Frederique; Mease, Philip J; Bøyesen, Pernille; Peterfy, Charles G; Conaghan, Philip G; Østergaard, Mikkel

    2015-12-01

    To assess changes following treatment and the reliability and responsiveness to change of the Outcome Measures in Rheumatology (OMERACT) Psoriatic Arthritis Magnetic Resonance Imaging Score (PsAMRIS) in a randomized controlled trial. Forty patients with PsA randomized to either placebo or abatacept (ABA) had MRI of either 1 hand (n = 20) or 1 foot (n = 20) at baseline and after 6 months. Images were scored blindly twice by 3 independent readers according to the PsAMRIS (for synovitis, tenosynovitis, periarticular inflammation, bone edema, bone erosion, and bone proliferation). Inflammatory features improved numerically but statistically nonsignificantly in the ABA group but not the placebo group. Baseline intrareader intraclass correlation coefficients (ICC) were good (≥ 0.50) to very good (≥ 0.80) for all features in both hand and foot. Baseline interreader ICC were good (ICC 0.72-0.96) for all features, except periarticular inflammation and bone proliferation in the hand and tenosynovitis in the foot (ICC 0.25-0.44). Intrareader and interreader ICC for change scores varied. Guyatt's responsiveness index (GRI) was high for inflammatory features in the hand and metatarsophalangeal joints (GRI -0.67 to -3.13; bone edema not calculable). Minimal change and low prevalence resulted in low ICC and GRI for bone damage. PsAMRIS showed overall good intrareader agreement in the hand and foot, and inflammatory feature scores were responsive to change, suggesting that PsAMRIS may be a valid tool for MRI assessment of hands and feet in PsA clinical trials.

  1. A meta-analysis to determine the effect of pharmacological and non-pharmacological treatments on fibromyalgia symptoms comprising OMERACT-10 response criteria.

    Papadopoulou, Despoina; Fassoulaki, Argyro; Tsoulas, Christos; Siafaka, Ioanna; Vadalouca, Athina

    2016-03-01

    Fibromyalgia is characterized by widespread pain, sleep problems, fatigue, functional impairment, psychological distress, and cognitive dysfunction. The objective of this meta-analysis is to synthesize the available data on the effectiveness of pharmacological and non-pharmacological interventions across all domains included in the Outcome Measures in Rheumatology Clinical Trials (OMERACT-10) fibromyalgia response definitions, and to examine response based on these definitions. We searched Cochrane, PubMed, Scopus, and the reference lists of articles for randomized controlled trials of any drug formulation or non-pharmacological intervention used for fibromyalgia treatment. We extracted efficacy data regarding pain, sleep, physical function, fatigue, anxiety, depression, and cognition. The available data were insufficient to draw definite conclusions regarding response. Indirect evidence indicates that it may be expected with the use of serotonin noradrenaline reuptake inhibitors (SNRIs), noradrenaline reuptake inhibitors (NRIs), and multidisciplinary treatment.

  2. The OMERACT ultrasound task force--status and perspectives

    Naredo, Esperanza; Wakefield, Richard J; Iagnocco, Annamaria

    2011-01-01

    - and interobserver reliability exercise; and (5) Delphi definition exercise in hand osteoarthritis, and reliability exercises. Study conclusions were discussed, and a future research agenda was approved, notably further validation of an OMERACT ultrasound global synovitis score (GLOSS) in RA, emphasizing......This article reports the most recent work of the Outcome Measures in Rheumatology (OMERACT) Ultrasound Task Force, and highlights the future research priorities discussed at the OMERACT 10 meeting. Results of the following studies were presented: (1) intra- and interobserver reliability...... of ultrasound detecting and scoring synovitis in different joints of patients with rheumatoid arthritis (RA); (2) systematic review of previous ultrasound scoring systems of synovitis in RA; (3) enthesitis systematic review and Delphi definition exercise in spondyloarthritis enthesitis; (4) enthesitis intra...

  3. Validity and sensitivity to change of the semi-quantitative OMERACT ultrasound scoring system for tenosynovitis in patients with rheumatoid arthritis

    Ammitzbøll-Danielsen, Mads; Østergaard, Mikkel; Naredo, Esperanza

    2016-01-01

    OBJECTIVES: The aim was to evaluate the metric properties of the semi-quantitative OMERACT US scoring system vs a novel quantitative US scoring system for tenosynovitis, by testing its intra- and inter-reader reliability, sensitivity to change and comparison with clinical tenosynovitis scoring...... in a 6-month follow-up study. METHODS: US and clinical assessments of the tendon sheaths of the clinically most affected hand and foot were performed at baseline, 3 and 6 months in 51 patients with RA. Tenosynovitis was assessed using the semi-quantitative scoring system (0-3) proposed by the OMERACT US...... tenosynovitis score was performed, calculating a sum score per patient. RESULTS: The intra- and inter-observer agreements for US tenosynovitis assessments were very good at baseline and for change for GS and CD, but less good for PI. The smallest detectable change was 0.97 for GS, 0.93 for CD and 30.1 for PI...

  4. Development and validation of the OMERACT rheumatoid arthritis magnetic resonance tenosynovitis scoring system in a multireader exercise

    Glinatsi, Daniel; Bird, Paul; Gandjbakhch, Frédérique

    2017-01-01

    Objective: To develop and validate a magnetic resonance imaging (MRI) tenosynovitis (TS) score for tendons at the wrist and metacarpophalangeal (MCP) joint levels in patients with rheumatoid arthritis (RA). Methods: Axial T1-weighted precontrast and postcontrast fat-saturated MR image sets...... of the hands of 43 patients with RA initiating rituximab therapy were obtained at baseline and after 14, 26, 38, or 52 weeks. The MR images were scored twice by 4 readers. Nine tendon compartments of the wrist and 4 flexor tendon compartments at the MCP joints were assessed. Tenosynovitis was scored as follows...

  5. Preliminary validation of 2 magnetic resonance image scoring systems for osteoarthritis of the hip according to the OMERACT filter.

    Maksymowych, Walter P; Cibere, Jolanda; Loeuille, Damien; Weber, Ulrich; Zubler, Veronika; Roemer, Frank W; Jaremko, Jacob L; Sayre, Eric C; Lambert, Robert G W

    2014-02-01

    Development of a validated magnetic resonance image (MRI) scoring system is essential in hip OA because radiographs are insensitive to change. We assessed the feasibility and reliability of 2 previously developed scoring methods: (1) the Hip Inflammation MRI Scoring System (HIMRISS) and (2) the Hip Osteoarthritis MRI Scoring System (HOAMS). Six readers (3 radiologists, 3 rheumatologists) participated in 2 reading exercises. In Reading Exercise 1, MRI of the hip of 20 subjects were read at a single time point followed by further standardization of methodology. In Reading Exercise 2, MRI of the hip of 18 subjects from a randomized controlled trial, assessed at 2 timepoints, and 27 subjects from a cross-sectional study were read for HIMRISS and HOAMS bone marrow lesions (BML) and synovitis. Reliability was assessed using intraclass correlation coefficient (ICC) and kappa statistics. Both methods were considered feasible. For Reading 1, HIMRISS ICC were 0.52, 0.61, 0.70, and 0.58 for femoral BML, acetabular BML, effusion, and total scores, respectively; and for HOAMS, summed BML and synovitis ICC were 0.52 and 0.46, respectively. For Reading 2, HIMRISS and HOAMS ICC for BML and synovitis-effusion improved substantially. Interobserver reliability for change scores was 0.81 and 0.71 for HIMRISS femoral and HOAMS summed BML, respectively. Responsiveness and discrimination was moderate to high for synovitis-effusion. Significant associations were noted between BML or synovitis scores and Western Ontario and McMaster Universities Osteoarthritis Index pain scores for baseline values (p ≤ 0.001). The BML and synovitis-effusion components of both HIMRISS and HOAMS scoring systems are feasible and reliable, and should be validated further.

  6. Development and Validation of the OMERACT Rheumatoid Arthritis Magnetic Resonance Tenosynovitis Scoring System in a Multireader Exercise.

    Glinatsi, Daniel; Bird, Paul; Gandjbakhch, Frédérique; Haavardsholm, Espen A; Peterfy, Charles G; Vital, Edward M; Emery, Paul; Conaghan, Philip G; Østergaard, Mikkel

    2017-11-01

    To develop and validate a magnetic resonance imaging (MRI) tenosynovitis (TS) score for tendons at the wrist and metacarpophalangeal (MCP) joint levels in patients with rheumatoid arthritis (RA). Axial T1-weighted precontrast and postcontrast fat-saturated MR image sets of the hands of 43 patients with RA initiating rituximab therapy were obtained at baseline and after 14, 26, 38, or 52 weeks. The MR images were scored twice by 4 readers. Nine tendon compartments of the wrist and 4 flexor tendon compartments at the MCP joints were assessed. Tenosynovitis was scored as follows: 0: No; 1: The overall PEA/PCA intrareader and interreader agreements for change scores in all tendons were 73.8%/97.6% and 47.9%/85.0%, respectively. Average SRM was moderate for total scores and 60.5% of the patients had a tenosynovitis change score ≥ SDC. The TS score showed high intrareader and interreader agreement for wrist and finger tendons, with moderate responsiveness, and the majority of the patients showed a change above the SDC. This scoring system may be included as a component of the RAMRIS.

  7. Validation of the OMERACT Psoriatic Arthritis Magnetic Resonance Imaging Score (PsAMRIS) for the Hand and Foot in a Randomized Placebo-controlled Trial

    Glinatsi, Daniel; Bird, Paul; Gandjbakhch, Frederique

    2015-01-01

    Objective. To assess changes following treatment and the reliability and responsiveness to change of the Outcome Measures in Rheumatology (OMERACT) Psoriatic Arthritis Magnetic Resonance Imaging Score (PsAMRIS) in a randomized controlled trial. Methods. Forty patients with PsA randomized to either...... placebo or abatacept (ABA) had MRI of either 1 hand (n = 20) or 1 foot (n = 20) at baseline and after 6 months. Images were scored blindly twice by 3 independent readers according to the PsAMRIS (for synovitis, tenosynovitis, periarticular inflammation, bone edema, bone erosion, and bone proliferation...

  8. Update on the OMERACT Magnetic Resonance Imaging Task Force

    Conaghan, Philip G; McQueen, Fiona M; Bird, Paul

    2014-01-01

    . The breadth of pathology in the Rheumatoid Arthritis MRI Score has been strengthened with further work on the development of a joint space narrowing score, and a series of exercises presented at OMERACT 11 demonstrated good reliability and construct validity for this assessment. Understanding the importance...... with substantial work presented on its iterative development, including pathology definition, scaling, and subsequent reliability of the score. Optimizing the role of MRI as a robust biomarker and surrogate outcome remains a priority for this group....

  9. The OMERACT MRI in Arthritis Working Group - Update on Status and Future Research Priorities.

    Østergaard, Mikkel; Bird, Paul; Gandjbakhch, Frédérique; Eshed, Iris; Haugen, Ida K; Haavardsholm, Espen A; Lillegraven, Siri; Foltz, Violaine; Glinatsi, Daniel; Peterfy, Charles; Ejbjerg, Bo; Bøyesen, Pernille; Mease, Philip J; Hermann, Kay-Geert; Emery, Paul; Genant, Harry K; Conaghan, Philip G

    2015-12-01

    To provide an update on the status and future research priorities of the Outcome Measures in Rheumatology (OMERACT) magnetic resonance imaging (MRI) in arthritis working group. A summary is provided of the activities of the group within rheumatoid arthritis (RA), psoriatic arthritis (PsA), and osteoarthritis (OA), and its research priorities. The OMERACT RA MRI score (RAMRIS) evaluating bone erosion, bone edema (osteitis), and synovitis is now the standard method of quantifying articular pathology in RA trials. Cartilage loss is another important part of joint damage, and at the OMERACT 12 conference, we provided longitudinal data demonstrating reliability and sensitivity to change of the RAMRIS JSN component score, supporting its use in future clinical trials. The MRI group has previously developed a PsA MRI score (PsAMRIS). At OMERACT 12, PsAMRIS was evaluated in a randomized placebo-controlled trial of patients with PsA, demonstrating the responsiveness and discriminatory ability of applying the PsAMRIS to hands and feet. A hand OA MRI score (HOAMRIS) was introduced at OMERACT 11, and has subsequently been further validated. At OMERACT 12, good cross-sectional interreader reliability, but variable reliability of change scores, were reported. Potential future research areas were identified at the MRI session at OMERACT 12 including assessment of tenosynovitis in RA and enthesitis in PsA and focusing on alternative MRI techniques. MRI has been further developed and validated as an outcome measure in RA, PsA, and OA. The group will continue its efforts to optimize the value of MRI as a robust biomarker in rheumatology clinical trials.

  10. Patients' Experience of Myositis and Further Validation of a Myositis-specific Patient Reported Outcome Measure - Establishing Core Domains and Expanding Patient Input on Clinical Assessment in Myositis. Report from OMERACT 12.

    Regardt, Malin; Basharat, Pari; Christopher-Stine, Lisa; Sarver, Catherine; Björn, Anita; Lundberg, Ingrid E; Wook Song, Yeong; Bingham, Clifton O; Alexanderson, Helene

    2015-12-01

    The Outcome Measures in Rheumatology (OMERACT) myositis working group was established to examine patient-reported outcomes (PRO) as well as to validate patient-reported outcome measures (PROM) in myositis. Qualitative studies using focus group interviews and cognitive debriefing of the myositis-specific Myositis Activities Profile (MAP) were used to explore the experience of adults living with polymyositis (PM) and dermatomyositis (DM). Preliminary results underscore the importance of patient input in the development of PROM to ensure content validity. Results from multicenter focus groups indicate the range of symptoms experienced including pain, fatigue, and impaired cognitive function, which are not currently assessed in myositis. Preliminary cognitive debriefing of the MAP indicated that while content was deemed relevant and important, several activities were not included; and that questionnaire construction and wording may benefit from revision. A research agenda was developed to continue work toward optimizing PRO assessment in myositis with 2 work streams. The first would continue to conduct and analyze focus groups until saturation in the thematic analysis was achieved to develop a framework that encompassed the patient-relevant aspects of myositis. The second would continue cognitive debriefing of the MAP to identify potential areas for revision. There was agreement that further work would be needed for inclusion body myositis and juvenile dermatomyositis, and that the inclusion of additional contributors such as caregivers and individuals from the pharmaceutical/regulatory spheres would be desirable. The currently used PROM do not assess symptoms or the effects of disease that are most important to patients; this emphasizes the necessity of patient involvement. Our work provides concrete examples for PRO identification.

  11. OMERACT Endorsement of Patient-reported Outcome Instruments in Antineutrophil Cytoplasmic Antibody–associated Vasculitis

    Robson, Joanna C.; Tomasson, Gunnar; Milman, Nataliya; Ashdown, Sue; Boonen, Annelies; Casey, George C.; Cronholm, Peter F.; Cuthbertson, David; Dawson, Jill; Direskeneli, Haner; Easley, Ebony; Kermani, Tanaz A.; Farrar, John T.; Gebhart, Don; Lanier, Georgia; Luqmani, Raashid A.; Mahr, Alfred; McAlear, Carol A.; Peck, Jacqueline; Shea, Beverley; Shea, Judy A.; Sreih, Antoine G.; Tugwell, Peter S.; Merkel, Peter A.

    2018-01-01

    Objective The antineutrophil cytoplasmic antibody–associated vasculitides (AAV) are multiorgan diseases. Patients with AAV report impairment in their health-related quality of life (HRQOL) and have different priorities regarding disease assessment compared with physicians. The Outcome Measures in Rheumatology (OMERACT) Vasculitis Working Group previously received endorsement for a core set of domains in AAV. Two approaches to measure patient-reported outcomes (PRO) were presented at OMERACT 2016. Methods A novel 5-step tool was used to facilitate assessment of the instruments by delegates: the OMERACT Filter 2.0 Instrument Selection Algorithm, with a red-amber-green checklist of questions, including (1) good match with domain (face and content validity), (2) feasibility, (3) do numeric scores make sense (construct validity)?, (4) overall ratings of discrimination, and (5) can individual thresholds of meaning be defined? Delegates gave an overall endorsement. Three generic Patient-Reported Outcomes Measurement Information System (PROMIS) instruments (fatigue, physical functioning, and pain interference) and a disease-specific PRO, the AAV-PRO (6 domains related to symptoms and HRQOL), were presented. Results OMERACT delegates endorsed the use of the PROMIS instruments for fatigue, physical functioning, and pain interference (87.6% overall endorsement) and the disease-specific AAV-PRO instrument (89.4% overall endorsement). Conclusion The OMERACT Vasculitis Working Group gained endorsement by OMERACT for use of the PROMIS and the AAV-PRO in clinical trials of vasculitis. These instruments are complementary to each other. The PROMIS and the AAV-PRO need further work to assess their utility in longitudinal settings, including their ability to discriminate between treatments of varying efficacy in the setting of a randomized controlled trial. PMID:28864650

  12. OMERACT Rheumatoid Arthritis Magnetic Resonance Imaging Studies. Summary of OMERACT 6 MR Imaging Module

    McQueen, F; Lassere, M; Edmonds, J

    2003-01-01

    Magnetic resonance image (MRI) scanning is a new method for imaging and quantifying joint inflammation and damage in rheumatoid arthritis (RA). Over the past 4 years, the OMERACT MR Imaging Group has been developing and testing the RA-MRI scoring system (RAMRIS) for use in RA. The OMERACT filter...

  13. [Criteria of scientific validity in research].

    Pelletier, Céline; Pagé, Ginette

    2002-03-01

    The purpose of this article is to present the evaluative criteria of qualitative and quantitative research. Philosophical foundations of positivism, postpositivism and constructivism are explored. Triangulation and crystallization expose the controversies about them. Finally, Lincoln and Guba criteria are retained for the evaluation of qualitative and quantitative research.

  14. The OMERACT Rheumatoid Arthritis Magnetic Resonance Imaging (MRI) Scoring System: Updated Recommendations by the OMERACT MRI in Arthritis Working Group.

    Østergaard, Mikkel; Peterfy, Charles G; Bird, Paul; Gandjbakhch, Frédérique; Glinatsi, Daniel; Eshed, Iris; Haavardsholm, Espen A; Lillegraven, Siri; Bøyesen, Pernille; Ejbjerg, Bo; Foltz, Violaine; Emery, Paul; Genant, Harry K; Conaghan, Philip G

    2017-11-01

    The Outcome Measures in Rheumatology (OMERACT) Rheumatoid Arthritis (RA) Magnetic Resonance Imaging (MRI) scoring system (RAMRIS), evaluating bone erosion, bone marrow edema/osteitis, and synovitis, was introduced in 2002, and is now the standard method of objectively quantifying inflammation and damage by MRI in RA trials. The objective of this paper was to identify subsequent advances and based on them, to provide updated recommendations for the RAMRIS. MRI studies relevant for RAMRIS and technical and scientific advances were analyzed by the OMERACT MRI in Arthritis Working Group, which used these data to provide updated considerations on image acquisition, RAMRIS definitions, and scoring systems for the original and new RA pathologies. Further, a research agenda was outlined. Since 2002, longitudinal studies and clinical trials have documented RAMRIS variables to have face, construct, and criterion validity; high reliability and sensitivity to change; and the ability to discriminate between therapies. This has enabled RAMRIS to demonstrate inhibition of structural damage progression with fewer patients and shorter followup times than has been possible with conventional radiography. Technical improvements, including higher field strengths and improved pulse sequences, allow higher image resolution and contrast-to-noise ratio. These have facilitated development and validation of scoring methods of new pathologies: joint space narrowing and tenosynovitis. These have high reproducibility and moderate sensitivity to change, and can be added to RAMRIS. Combined scores of inflammation or joint damage may increase sensitivity to change and discriminative power. However, this requires further research. Updated 2016 RAMRIS recommendations and a research agenda were developed.

  15. Validation of proposed diagnostic criteria (the "Budapest Criteria") for Complex Regional Pain Syndrome.

    Harden, R Norman; Bruehl, Stephen; Perez, Roberto S G M; Birklein, Frank; Marinus, Johan; Maihofner, Christian; Lubenow, Timothy; Buvanendran, Asokumar; Mackey, Sean; Graciosa, Joseph; Mogilevski, Mila; Ramsden, Christopher; Chont, Melissa; Vatine, Jean-Jacques

    2010-08-01

    Current IASP diagnostic criteria for CRPS have low specificity, potentially leading to overdiagnosis. This validation study compared current IASP diagnostic criteria for CRPS to proposed new diagnostic criteria (the "Budapest Criteria") regarding diagnostic accuracy. Structured evaluations of CRPS-related signs and symptoms were conducted in 113 CRPS-I and 47 non-CRPS neuropathic pain patients. Discriminating between diagnostic groups based on presence of signs or symptoms meeting IASP criteria showed high diagnostic sensitivity (1.00), but poor specificity (0.41), replicating prior work. In comparison, the Budapest clinical criteria retained the exceptional sensitivity of the IASP criteria (0.99), but greatly improved upon the specificity (0.68). As designed, the Budapest research criteria resulted in the highest specificity (0.79), again replicating prior work. Analyses indicated that inclusion of four distinct CRPS components in the Budapest Criteria contributed to enhanced specificity. Overall, results corroborate the validity of the Budapest Criteria and suggest they improve upon existing IASP diagnostic criteria for CRPS. Copyright (c) 2010 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.

  16. A Preliminary Core Domain Set for Clinical Trials of Shoulder Disorders: A Report from the OMERACT 2016 Shoulder Core Outcome Set Special Interest Group.

    Buchbinder, Rachelle; Page, Matthew J; Huang, Hsiaomin; Verhagen, Arianne P; Beaton, Dorcas; Kopkow, Christian; Lenza, Mario; Jain, Nitin B; Richards, Bethan; Richards, Pamela; Voshaar, Marieke; van der Windt, Danielle; Gagnier, Joel J

    2017-12-01

    The Outcome Measures in Rheumatology (OMERACT) Shoulder Core Outcome Set Special Interest Group (SIG) was established to develop a core outcome set (COS) for clinical trials of shoulder disorders. In preparation for OMERACT 2016, we systematically examined all outcome domains and measurement instruments reported in 409 randomized trials of interventions for shoulder disorders published between 1954 and 2015. Informed by these data, we conducted an international Delphi consensus study including shoulder trial experts, clinicians, and patients to identify key domains that should be included in a shoulder disorder COS. Findings were discussed at a stakeholder premeeting of OMERACT. At OMERACT 2016, we sought consensus on a preliminary core domain set and input into next steps. There were 13 and 15 participants at the premeeting and the OMERACT 2016 SIG meeting, respectively (9 attended both meetings). Consensus was reached on a preliminary core domain set consisting of an inner core of 4 domains: pain, physical function/activity, global perceived effect, and adverse events including death. A middle core consisted of 3 domains: emotional well-being, sleep, and participation (recreation and work). An outer core of research required to inform the final COS was also formulated. Our next steps are to (1) analyze whether participation (recreation and work) should be in the inner core, (2) conduct a third Delphi round to finalize definitions and wording of domains and reach final endorsement for the domains, and (3) determine which instruments fulfill the OMERACT criteria for measuring each domain.

  17. The OMERACT ultrasound task force -- Advances and priorities

    D'Agostino, Maria-Antonietta; Conaghan, Philip G; Naredo, Esperanza

    2009-01-01

    This article reports the most recent work of the OMERACT Ultrasound Task Force (post OMERACT 8) and highlights of future research priorities discussed at the OMERACT 9 meeting, Kananaskis, Canada, May 2008. Results of 3 studies were presented: (1) assessing intermachine reliability; (2) applying...... system for the hand on other joints (including shoulder). Study conclusions were discussed and a future research agenda was generated, notably the further development of a Global OMERACT Sonography Scoring (GLOSS) system in RA, emphasizing the importance of testing feasibility and added value over...... standard clinical variables. Future disease areas of importance to develop include a scoring system for enthesitis and osteoarthritis....

  18. Validation criteria of an internal dosimetry laboratory in vivo

    Alfaro L, M. de las M.

    2014-10-01

    People working with radioactive materials, under certain circumstances (e.g. not using the proper protective equipment, an incident not covered, etc.) could be incorporated into the body. The radiation protection programs include direct measurement methods -in vivo- or indirect -in vitro- or both, to know that radioactive material is incorporated into the body. The monitoring measurements of internal contamination or (Radio-bioassay) are carried out with the purpose of determining the amount of radioactive material incorporated in the body; estimate the effective dose and committed dose; management administration of radiation protection; appropriate medical management; and to provide the data necessary for the legal requirements and the preservation of records. The measurement methods used in the monitoring of internal contamination must be validated by the combination of the following processes: calibration, using standards reference materials and/or simulators; execute systematic research, using control samples; and intercomparison between laboratories and performance tests. In this paper the validation criteria of an internal dosimetry laboratory in vivo are presented following the information provided by the standard ANSI N13-30-1996 and ISO/TEC 17025-2005 as are the criteria of facilities, staff training, interpretation of measurements, performance criteria for monitoring of internal contamination in vivo, results reporting and records retention. Thereby we achieve standardized quantitative performance criteria of truthfulness, accuracy and detection limit and a consensus on statistical definitions to establish the validation plan of a monitoring laboratory of internal contamination in vivo. (Author)

  19. Validation of Proposed "DSM-5" Criteria for Autism Spectrum Disorder

    Frazier, Thomas W.; Youngstrom, Eric A.; Speer, Leslie; Embacher, Rebecca; Law, Paul; Constantino, John; Findling, Robert L.; Hardan, Antonio Y.; Eng, Charis

    2012-01-01

    Objective: The primary aim of the present study was to evaluate the validity of proposed "DSM-5" criteria for autism spectrum disorder (ASD). Method: We analyzed symptoms from 14,744 siblings (8,911 ASD and 5,863 non-ASD) included in a national registry, the Interactive Autism Network. Youth 2 through 18 years of age were included if at least one…

  20. Responsiveness in rheumatoid arthritis. a report from the OMERACT 11 ultrasound workshop.

    Iagnocco, Annamaria; Naredo, Esperanza; Wakefield, Richard; Bruyn, George A W; Collado, Paz; Jousse-Joulin, Sandrine; Finzel, Stephanie; Ohrndorf, Sarah; Delle Sedie, Andrea; Backhaus, Marina; Berner-Hammer, Hilde; Gandjbakhch, Frederique; Kaeley, Gurjit; Loeuille, Damien; Moller, Ingrid; Terslev, Lene; Aegerter, Philippe; Aydin, Sibel; Balint, Peter V; Filippucci, Emilio; Mandl, Peter; Pineda, Carlos; Roth, Johannes; Magni-Manzoni, Silvia; Tzaribachev, Niolay; Schmidt, Wolfgang A; Conaghan, Philip G; D'Agostino, Maria-Antonietta

    2014-02-01

    To summarize the work performed by the Outcome Measures in Rheumatology (OMERACT) Ultrasound (US) Task Force on the validity of different US measures in rheumatoid arthritis (RA) and juvenile idiopathic arthritis (JIA) presented during the OMERACT 11 Workshop. The Task Force is an international group aiming to iteratively improve the role of US in arthritis clinical trials. Recently a major focus of the group has been the assessment of responsiveness of a person-level US synovitis score in RA: the US Global Synovitis Score (US-GLOSS) combines synovial hypertrophy and power Doppler signal in a composite score detected at joint level. Work has also commenced examining assessment of tenosynovitis in RA and the role of US in JIA. The US-GLOSS was tested in a large RA cohort treated with biologic therapy. It showed early signs of improvement in synovitis starting at Day 7 and increasing to Month 6, and demonstrated sensitivity to change of the proposed grading. Subsequent voting questions concerning the application of the US-GLOSS were endorsed by > 80% of OMERACT delegates. A standardized US scoring system for detecting and grading severity of RA tenosynovitis and tendon damage has been developed, and acceptable reliability data were presented from a series of exercises. A preliminary consensus definition of US synovitis in pediatric arthritis has been developed and requires further testing. At OMERACT 11, consensus was achieved on the application of the US-GLOSS for evaluating synovitis in RA; and work continues on development of RA tenosynovitis scales as well as in JIA synovitis.

  1. The OMERACT ultrasound task force -- Advances and priorities.

    D'Agostino, Maria-Antonietta

    2009-08-01

    This article reports the most recent work of the OMERACT Ultrasound Task Force (post OMERACT 8) and highlights of future research priorities discussed at the OMERACT 9 meeting, Kananaskis, Canada, May 2008. Results of 3 studies were presented: (1) assessing intermachine reliability; (2) applying the scoring system developed in the hand to other joints most commonly affected in rheumatoid arthritis (RA); and (3) assessing interobserver reliability on a deep target joint (shoulder). Results demonstrated good intermachine reliability between multiple examiners, and good applicability of the scoring system for the hand on other joints (including shoulder). Study conclusions were discussed and a future research agenda was generated, notably the further development of a Global OMERACT Sonography Scoring (GLOSS) system in RA, emphasizing the importance of testing feasibility and added value over standard clinical variables. Future disease areas of importance to develop include a scoring system for enthesitis and osteoarthritis.

  2. Criteria of the validation of experimental and evaluated covariance data

    Badikov, S.

    2008-01-01

    The criteria of the validation of experimental and evaluated covariance data are reviewed. In particular: a) the criterion of the positive definiteness for covariance matrices, b) the relationship between the 'integral' experimental and estimated uncertainties, c) the validity of the statistical invariants, d) the restrictions imposed to correlations between experimental errors, are described. Applying these criteria in nuclear data evaluation was considered and 4 particular points have been examined. First preserving positive definiteness of covariance matrices in case of arbitrary transformation of a random vector was considered, properties of the covariance matrices in operations widely used in neutron and reactor physics (splitting and collapsing energy groups, averaging the physical values over energy groups, estimation parameters on the basis of measurements by means of generalized least squares method) were studied. Secondly, an algorithm for comparison of experimental and estimated 'integral' uncertainties was developed, square root of determinant of a covariance matrix is recommended for use in nuclear data evaluation as a measure of 'integral' uncertainty for vectors of experimental and estimated values. Thirdly, a set of statistical invariants-values which are preserved in statistical processing was presented. And fourthly, the inequality that signals a correlation between experimental errors that leads to unphysical values is given. An application is given concerning the cross-section of the (n,t) reaction on Li 6 with a neutron incident energy comprised between 1 and 100 keV

  3. Developing an OMERACT Core Outcome Set for Assessing Safety Components in Rheumatology Trials: The OMERACT Safety Working Group.

    Klokker, Louise; Tugwell, Peter; Furst, Daniel E; Devoe, Dan; Williamson, Paula; Terwee, Caroline B; Suarez-Almazor, Maria E; Strand, Vibeke; Woodworth, Thasia; Leong, Amye L; Goel, Niti; Boers, Maarten; Brooks, Peter M; Simon, Lee S; Christensen, Robin

    2017-12-01

    Failure to report harmful outcomes in clinical research can introduce bias favoring a potentially harmful intervention. While core outcome sets (COS) are available for benefits in randomized controlled trials in many rheumatic conditions, less attention has been paid to safety in such COS. The Outcome Measures in Rheumatology (OMERACT) Filter 2.0 emphasizes the importance of measuring harms. The Safety Working Group was reestablished at the OMERACT 2016 with the objective to develop a COS for assessing safety components in trials across rheumatologic conditions. The safety issue has previously been discussed at OMERACT, but without a consistent approach to ensure harms were included in COS. Our methods include (1) identifying harmful outcomes in trials of interventions studied in patients with rheumatic diseases by a systematic literature review, (2) identifying components of safety that should be measured in such trials by use of a patient-driven approach including qualitative data collection and statistical organization of data, and (3) developing a COS through consensus processes including everyone involved. Members of OMERACT including patients, clinicians, researchers, methodologists, and industry representatives reached consensus on the need to continue the efforts on developing a COS for safety in rheumatology trials. There was a general agreement about the need to identify safety-related outcomes that are meaningful to patients, framed in terms that patients consider relevant so that they will be able to make informed decisions. The OMERACT Safety Working Group will advance the work previously done within OMERACT using a new patient-driven approach.

  4. Simulation Methods and Validation Criteria for Modeling Cardiac Ventricular Electrophysiology.

    Shankarjee Krishnamoorthi

    Full Text Available We describe a sequence of methods to produce a partial differential equation model of the electrical activation of the ventricles. In our framework, we incorporate the anatomy and cardiac microstructure obtained from magnetic resonance imaging and diffusion tensor imaging of a New Zealand White rabbit, the Purkinje structure and the Purkinje-muscle junctions, and an electrophysiologically accurate model of the ventricular myocytes and tissue, which includes transmural and apex-to-base gradients of action potential characteristics. We solve the electrophysiology governing equations using the finite element method and compute both a 6-lead precordial electrocardiogram (ECG and the activation wavefronts over time. We are particularly concerned with the validation of the various methods used in our model and, in this regard, propose a series of validation criteria that we consider essential. These include producing a physiologically accurate ECG, a correct ventricular activation sequence, and the inducibility of ventricular fibrillation. Among other components, we conclude that a Purkinje geometry with a high density of Purkinje muscle junctions covering the right and left ventricular endocardial surfaces as well as transmural and apex-to-base gradients in action potential characteristics are necessary to produce ECGs and time activation plots that agree with physiological observations.

  5. Simulation Methods and Validation Criteria for Modeling Cardiac Ventricular Electrophysiology.

    Krishnamoorthi, Shankarjee; Perotti, Luigi E; Borgstrom, Nils P; Ajijola, Olujimi A; Frid, Anna; Ponnaluri, Aditya V; Weiss, James N; Qu, Zhilin; Klug, William S; Ennis, Daniel B; Garfinkel, Alan

    2014-01-01

    We describe a sequence of methods to produce a partial differential equation model of the electrical activation of the ventricles. In our framework, we incorporate the anatomy and cardiac microstructure obtained from magnetic resonance imaging and diffusion tensor imaging of a New Zealand White rabbit, the Purkinje structure and the Purkinje-muscle junctions, and an electrophysiologically accurate model of the ventricular myocytes and tissue, which includes transmural and apex-to-base gradients of action potential characteristics. We solve the electrophysiology governing equations using the finite element method and compute both a 6-lead precordial electrocardiogram (ECG) and the activation wavefronts over time. We are particularly concerned with the validation of the various methods used in our model and, in this regard, propose a series of validation criteria that we consider essential. These include producing a physiologically accurate ECG, a correct ventricular activation sequence, and the inducibility of ventricular fibrillation. Among other components, we conclude that a Purkinje geometry with a high density of Purkinje muscle junctions covering the right and left ventricular endocardial surfaces as well as transmural and apex-to-base gradients in action potential characteristics are necessary to produce ECGs and time activation plots that agree with physiological observations.

  6. Developing a Construct to Evaluate Flares in Rheumatoid Arthritis: A Conceptual Report of the OMERACT RA Flare Definition Working Group

    Alten, Rieke; Choy, Ernest H; Christensen, Robin

    2011-01-01

    Rheumatoid arthritis (RA) patients and healthcare professionals (HCP) recognize that episodic worsening disease activity, often described as a "flare," is a common feature of RA that can contribute to impaired function and disability. However, there is no standard definition to enable measurement...... of its intensity and impact. The conceptual framework of the Outcome Measures in Rheumatology Clinical Trials (OMERACT) RA Flare Definition Working Group includes an anchoring statement, developed at OMERACT 9 in 2008: "flare in RA" is defined as worsening of signs and symptoms of sufficient intensity....... The conceptual framework of flare takes into account validated approaches to measurement in RA: (1) various disease activity indices (e.g., Disease Activity Score, Clinical Disease Activity Index, Simplified Disease Activity Index); (2) use of patient-reported outcomes (PRO); and (3) characterization...

  7. Validating Rheumatoid Arthritis Remission Using the Patients' Perspective

    Rasch, Linda A; Boers, Maarten; Hill, Catherine L

    2017-01-01

    OBJECTIVE: The Outcome Measures in Rheumatology (OMERACT) working group on the patients' perspective on remission in rheumatoid arthritis (RA) has been working on this topic since 2010. At OMERACT 2016, progress and preliminary data on validity of measurement instruments for pain, fatigue...

  8. The OMERACT Ultrasound Working Group 10 Years On

    Bruyn, George A; Naredo, Esperanza; Iagnocco, Annamaria

    2015-01-01

    Musculoskeletal ultrasound (US) now thrives as an established imaging modality for the investigation and management of chronic inflammatory arthritis. We summarize here results of the Outcome Measures in Rheumatology (OMERACT) US working group (WG) projects of the last 2 years. These results were...

  9. Validation of potential classification criteria for systemic sclerosis.

    Johnson, S.R.; Fransen, J.; Khanna, D.; Baron, M.; Hoogen, F. van den; Medsger TA, J.r.; Peschken, C.A.; Carreira, P.E.; Riemekasten, G.; Tyndall, A.; Matucci-Cerinic, M.; Pope, J.E.

    2012-01-01

    OBJECTIVE: Classification criteria for systemic sclerosis (SSc; scleroderma) are being updated jointly by the American College of Rheumatology and European League Against Rheumatism. Potential items for classification were reduced to 23 using Delphi and nominal group techniques. We evaluated the

  10. 40 CFR 1065.514 - Cycle-validation criteria for operation over specified duty cycles.

    2010-07-01

    ... 40 Protection of Environment 32 2010-07-01 2010-07-01 false Cycle-validation criteria for operation over specified duty cycles. 1065.514 Section 1065.514 Protection of Environment ENVIRONMENTAL... Over Specified Duty Cycles § 1065.514 Cycle-validation criteria for operation over specified duty...

  11. Validation of the Rome III criteria and alarm symptoms for recurrent abdominal pain in children

    Gijsbers, Carolien F. M.; Benninga, Marc A.; Schweizer, Joachim J.; Kneepkens, C. M. Frank; Vergouwe, Yvonne; Büller, Hans A.

    2014-01-01

    Rome criteria were formulated to define functional gastrointestinal disorders (Rome III criteria, 2006) excluding organic diagnoses when alarm symptoms were absent. The aims of the study were to validate the Rome III criteria as to their capacity to differentiate between organic and functional

  12. TWO CRITERIA FOR GOOD MEASUREMENTS IN RESEARCH: VALIDITY AND RELIABILITY

    Haradhan Kumar Mohajan

    2017-12-01

    Full Text Available Reliability and validity are two most important and fundamental features in the evaluation of any measurement instrument or toll for a good research. The purpose of this research is to discuss the validity and reliability of measurement instruments that are used in research. Validity concerns what an instrument measures, and how well it does so. Reliability concerns the faith that one can have in the data obtained from use of an instrument, that is, the degree to which any measuring tool controls for random error. An attempt has been taken here to review the reliability and validity, and threat to them in some details.

  13. A converse to linear independence criteria, valid almost everywhere

    Fischler, Stéphane; Hussain, Mumtaz; Kristensen, Simon

    We prove a weighted analogue of the Khintchine-Groshev Theorem, where the distance to the nearest integer is replaced by the absolute value. This is subsequently applied to proving the optimality of several linear independence criteria over the field of rational numbers.......We prove a weighted analogue of the Khintchine-Groshev Theorem, where the distance to the nearest integer is replaced by the absolute value. This is subsequently applied to proving the optimality of several linear independence criteria over the field of rational numbers....

  14. Recommendations for the Involvement of Patient Research Partners (PRP) in OMERACT Working Groups. A Report from the OMERACT 2014 Working Group on PRP.

    Cheung, Peter P; de Wit, Maarten; Bingham, Clifton O; Kirwan, John R; Leong, Amye; March, Lyn M; Montie, Pam; Scholte-Voshaar, Marieke; Gossec, Laure

    2016-01-01

    Patient participation in research is increasing; however, practical guidelines to enhance this participation are lacking. Specifically within the Outcome Measures in Rheumatology (OMERACT) organization, although patients have participated in OMERACT meetings since 2002, consensus about the procedures for involving patients in working groups has not been formalized. The objective is to develop a set of recommendations regarding patient research partner (PRP) involvement in research working groups. We conducted a systematic literature review on recommendations/guidelines of PRP involvement in research; elaborated a structured consensus process involving multiple participants to develop a set of recommendations; and sought endorsement of recommendations by OMERACT. In the 18 articles included in the literature review, there was general agreement on the broad concepts for recommendations covering PRP involvement in research although they were heterogeneous in detail. Most considered PRP involvement in all phases of research with early engagement, training, and support important, but details on the content were scarce. This review informed a larger consensus-building process regarding PRP inclusion in OMERACT research. Three overarching principles and 8 recommendations were developed, discussed, and refined at OMERACT 2014. The guiding principles were endorsed during the OMERACT plenary session. These recommendations for PRP involvement in OMERACT research reinforce the importance of patient participation throughout the research process as integral members. Although the applicability of the recommendations in other research contexts should be assessed, the generalizability is expected to be high. Future research should evaluate their implementation and their effect on outcome development.

  15. The OMERACT rheumatoid arthritis magnetic resonance imaging (MRI) scoring system

    Østergaard, Mikkel; Peterfy, Charles G.; Bird, Paul

    2017-01-01

    Objective: The Outcome Measures in Rheumatology (OMERACT) Rheumatoid Arthritis (RA) Magnetic Resonance Imaging (MRI) scoring system (RAMRIS), evaluating bone erosion, bone marrow edema/osteitis, and synovitis, was introduced in 2002, and is now the standard method of objectively quantifying...... inflammation and damage by MRI in RA trials. The objective of this paper was to identify subsequent advances and based on them, to provide updated recommendations for the RAMRIS. Methods: MRI studies relevant for RAMRIS and technical and scientific advances were analyzed by the OMERACT MRI in Arthritis Working...... Group, which used these data to provide updated considerations on image acquisition, RAMRIS definitions, and scoring systems for the original and new RA pathologies. Further, a research agenda was outlined. Results: Since 2002, longitudinal studies and clinical trials have documented RAMRIS variables...

  16. Derivation and validation of the Systemic Lupus International Collaborating Clinics classification criteria for systemic lupus erythematosus

    Petri, Michelle; Orbai, Ana-Maria; Alarcón, Graciela S

    2012-01-01

    The Systemic Lupus International Collaborating Clinics (SLICC) group revised and validated the American College of Rheumatology (ACR) systemic lupus erythematosus (SLE) classification criteria in order to improve clinical relevance, meet stringent methodology requirements, and incorporate new...

  17. The OMERACT Magnetic Resonance Imaging Inflammatory Arthritis Group - advances and priorities

    Østergaard, Mikkel; McQueen, Fiona; Bird, Paul

    2007-01-01

    This article updates the work and research priorities of the OMERACT working group on magnetic resonance imaging (MRI) in inflammatory arthritis, as presented to the OMERACT 8 meeting in Malta in May 2006. This work focused on testing the reliability of dedicated extremity MRI in rheumatoid arthr...

  18. The OMERACT MRI inflammatory arthritis group: advances and future research priorities

    Conaghan, Philip G; Bird, Paul; McQueen, Fiona

    2009-01-01

    The OMERACT magnetic resonance imaging (MRI) in inflammatory arthritis group previously developed the rheumatoid arthritis MRI score (RAMRIS) for use in clinical studies, evaluated the use of extremity MRI, and initiated development of a psoriatic arthritis MRI score (PsAMRIS). At OMERACT 9 the g...

  19. The OMERACT Magnetic Resonance Imaging Inflammatory Arthritis Group - advances and priorities

    Østergaard, Mikkel; McQueen, Fiona; Bird, Paul

    2007-01-01

    This article updates the work and research priorities of the OMERACT working group on magnetic resonance imaging (MRI) in inflammatory arthritis, as presented to the OMERACT 8 meeting in Malta in May 2006. This work focused on testing the reliability of dedicated extremity MRI in rheumatoid...

  20. The Bulimia Test--Revised: Validation with "DSM-IV" Criteria for Bulimia Nervosa.

    Thelen, Mark H.; And Others

    1996-01-01

    The Bulimia Test--Revised (BULIT-R) was given to 23 female subjects who met the criteria for bulimia in the "Diagnostic and Statistical Manual of Mental Disorders" (DSM-IV) and 124 female controls. The BULIT-R appears to be a valid instruction for identifying individuals who meet DSM-IV criteria for bulimia. (SLD)

  1. Validity of helicopter emergency medical services dispatch criteria for traumatic injuries: A systematic review

    A.N. Ringburg (Akkie); G. de Ronde (Gijs); S. Thomas (Siep); E.M.M. van Lieshout (Esther); P. Patka (Peter); I.B. Schipper (Inger)

    2009-01-01

    textabstractObjective. This review provides an overview of the validity of Helicopter Emergency Medical Services (HEMS) dispatch criteria for severely injured patients. Methods. A systematic literature search was performed. English written and peer-reviewed publications on HEMS dispatch criteria

  2. Patient-reported outcomes and adult patients' disease experience in the idiopathic inflammatory myopathies. report from the OMERACT 11 Myositis Special Interest Group.

    Alexanderson, Helene; Del Grande, Maria; Bingham, Clifton O; Orbai, Ana-Maria; Sarver, Catherine; Clegg-Smith, Katherine; Lundberg, Ingrid E; Song, Yeong Wook; Christopher-Stine, Lisa

    2014-03-01

    The newly formed Outcome Measures in Rheumatology (OMERACT) Myositis Special Interest Group (SIG) was established to examine patient-reported outcome measures (PROM) in myositis. At OMERACT 11, a literature review of PROM used in the idiopathic inflammatory myopathies (IIM) and other neuromuscular conditions was presented. The group examined in more detail 2 PROM more extensively evaluated in patients with IIM, the Myositis Activities Profile, and the McMaster-Toronto Arthritis Patient Preference Disability Questionnaire, through the OMERACT filter of truth, discrimination, and feasibility. Preliminary results from a qualitative study of patients with myositis regarding their symptoms were discussed that emphasized the range of symptoms experienced: pain, physical tightness/stiffness, fatigue, disease effect on emotional life and relationships, and treatment-related side effects. Following discussion of these results and following additional discussions since OMERACT 11, a research agenda was developed. The next step in evaluating PROM in IIM will require additional focus groups with a spectrum of patients with different myositis disease phenotypes and manifestations across a range of disease activity, and from multiple international settings. The group will initially focus on dermatomyositis and polymyositis in adults. Qualitative analysis will facilitate the identification of commonalities and divergent patient-relevant aspects of disease, insights that are critical given the heterogeneous manifestations of these diseases. Based on these qualitative studies, existing myositis PROM can be examined to more thoroughly assess content validity, and will be important to identify gaps in domain measurement that will be required to develop a preliminary core set of patient-relevant domains for IIM.

  3. Approaches to Demonstrating the Reliability and Validity of Core Diagnostic Criteria for Chronic Pain.

    Bruehl, Stephen; Ohrbach, Richard; Sharma, Sonia; Widerstrom-Noga, Eva; Dworkin, Robert H; Fillingim, Roger B; Turk, Dennis C

    2016-09-01

    The Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks-American Pain Society Pain Taxonomy (AAPT) is designed to be an evidence-based multidimensional chronic pain classification system that will facilitate more comprehensive and consistent chronic pain diagnoses, and thereby enhance research, clinical communication, and ultimately patient care. Core diagnostic criteria (dimension 1) for individual chronic pain conditions included in the initial version of AAPT will be the focus of subsequent empirical research to evaluate and provide evidence for their reliability and validity. Challenges to validating diagnostic criteria in the absence of clear and identifiable pathophysiological mechanisms are described. Based in part on previous experience regarding the development of evidence-based diagnostic criteria for psychiatric disorders, headache, and specific chronic pain conditions (fibromyalgia, complex regional pain syndrome, temporomandibular disorders, pain associated with spinal cord injuries), several potential approaches for documentation of the reliability and validity of the AAPT diagnostic criteria are summarized. The AAPT is designed to be an evidence-based multidimensional chronic pain classification system. Conceptual and methodological issues related to demonstrating the reliability and validity of the proposed AAPT chronic pain diagnostic criteria are discussed. Copyright © 2016 American Pain Society. Published by Elsevier Inc. All rights reserved.

  4. Development and validation of sustainability criteria of administrative green schools in Iran.

    Meiboudi, Hossein; Lahijanian, Akramolmolok; Shobeiri, Seyed Mohammad; Jozi, Seyed Ali; Azizinezhad, Reza

    2017-07-15

    Environmental responsibility in school has led to the emergence of a variety of criteria to administer green schools' contributions to sustainability. Sustainability criteria of administrative green schools need validity, reliability and norms. The aim of the current study was to develop and validate assessment criteria for green schools in Iran based on the role of academia. A national survey was conducted to obtain data on sustainability criteria initiatives for green schools and the Iranian profile was defined. An initial pool of 71 items was generated and after its first edition, 63 items were selected to comprise the sustainability criteria. Engineering-architectural and behavioral aspects of this sustainability criteria were evaluated through a sample of 1218 graduate students with environmental degrees from Iran's universities. Exploratory factor analysis using principal components and promax rotation method showed that these 9 criteria have simple structures and are consistent with the theoretical framework. The reliability coefficients of subscales ranged between 0.62 (participation) and 0.84 (building location and position). The study's survey of correlation coefficients between items and subscales illustrated that those coefficients varied between 0.24 and 0.68. Copyright © 2017 Elsevier Ltd. All rights reserved.

  5. Development and Validation of Quality Criteria for Providing Patient- and Family-centered Injury Care.

    Boyd, Jamie M; Burton, Rachael; Butler, Barb L; Dyer, Dianne; Evans, David C; Felteau, Melissa; Gruen, Russell L; Jaffe, Kenneth M; Kortbeek, John; Lang, Eddy; Lougheed, Val; Moore, Lynne; Narciso, Michelle; Oxland, Peter; Rivara, Frederick P; Roberts, Derek; Sarakbi, Diana; Vine, Karen; Stelfox, Henry T

    2017-08-01

    The aim of this study was to develop and evaluate the content validity of quality criteria for providing patient- and family-centered injury care. Quality criteria have been developed for clinical injury care, but not patient- and family-centered injury care. Using a modified Research AND Development Corporation (RAND)/University of California, Los Angeles (UCLA) Appropriateness Methodology, a panel of 16 patients, family members, injury and quality of care experts serially rated and revised criteria for patient- and family-centered injury care identified from patient and family focus groups. The criteria were then sent to 384 verified trauma centers in the United States, Canada, Australia, and New Zealand for evaluation. A total of 46 criteria were rated and revised by the panel over 4 rounds of review producing 14 criteria related to clinical care (n = 4; transitions of care, pain management, patient safety, provider competence), communication (n = 3; information for patients/families; communication of discharge plans to patients/families, communication between hospital and community providers), holistic care (n = 4; patient hygiene, kindness and respect, family access to patient, social and spiritual support) and end-of-life care (n = 3; decision making, end-of-life care, family follow-up). Medical directors, managers, or coordinators representing 254 trauma centers (66% response rate) rated 12 criteria to be important (95% of responses) for patient- and family-centered injury care. Fewer centers rated family access to the patient (80%) and family follow-up after patient death (65%) to be important criteria. Fourteen-candidate quality criteria for patient- and family-centered injury care were developed and shown to have content validity. These may be used to guide quality improvement practices.

  6. Diagnostic validity of criteria for sacroiliac joint pain: a systematic review

    Szadek, K.M.; van der Wurff, P.; van Tulder, M.W.; Zuurmond, W.W.A.; Perez, R.S.G.M.

    2009-01-01

    A systematic literature review was conducted to determine the diagnostic validity of the criteria for sacroiliac (SI) joint pain as proposed by the International Association for the Study of Pain (IASP). Databases were searched up to September 2007. Quality of the studies was assessed using a

  7. Diagnostic Validity of Criteria for Sacroiliac Joint Pain : A Systematic Review

    Szadek, Karolina M.; van der Wurff, Peter; van Tulder, Maurits W.; Zuurmond, Wouter W.; Perez, Roberto S. G. M.

    A systematic literature review was conducted to determine the diagnostic validity of the criteria for sacroiliac (SI) joint pain as proposed by the International Association for the Study of Pain (IASP). Databases were searched up to September 2007. Quality of the studies was assessed using a

  8. A predictive validity study of the Learning Style Questionnaire (LSQ) using multiple, specific learning criteria

    Kappe, F.R.; Boekholt, L.; den Rooyen, C.; van der Flier, H.

    2009-01-01

    Multiple and specific learning criteria were used to examine the predictive validity of the Learning Style Questionnaire (LSQ). Ninety-nine students in a college of higher learning in The Netherlands participated in a naturally occurring field study. The students were categorized into one of four

  9. Predictive validity of proposed remission criteria in first-episode schizophrenic patients responding to antipsychotics

    Wunderink, Lex; Nienhuis, Fokko J.; Sytema, Sjoerd; Wiersma, Durk

    The objective of this study was to examine the predictive validity of the remission criteria proposed by Andreasen et all in first-episode patients responding to antipsychotics. Antipsychotic responsive patients with first-episode schizophrenia showing symptom remission (n = 60) were compared with

  10. Developing an OMERACT Core Outcome Set for Assessing Safety Components in Rheumatology Trials

    Klokker, Louise; Tugwell, Peter; Furst, Daniel E

    2016-01-01

    in such COS. The Outcome Measures in Rheumatology (OMERACT) Filter 2.0 emphasizes the importance of measuring harms. The Safety Working Group was reestablished at the OMERACT 2016 with the objective to develop a COS for assessing safety components in trials across rheumatologic conditions. METHODS: The safety......OBJECTIVE: Failure to report harmful outcomes in clinical research can introduce bias favoring a potentially harmful intervention. While core outcome sets (COS) are available for benefits in randomized controlled trials in many rheumatic conditions, less attention has been paid to safety...... that patients consider relevant so that they will be able to make informed decisions. CONCLUSION: The OMERACT Safety Working Group will advance the work previously done within OMERACT using a new patient-driven approach....

  11. Study of Validity Criteria for Radionuclide-Analysis of Low- and Intermediate-Level Radioactive Waste

    Kim, Ji Uk; Baek, Hyun Suk; Jeong, Sung Yeop [Sungwoo E and T Co., Hanam (Korea, Republic of); Shin, Seung Kyu [Korea Radioactive waste Management Corporation, Gyeongju (Korea, Republic of)

    2013-05-15

    Literature survey on the deviation of the measuring equipment and statistical analysis on the measured data of domestic LILW were performed in order to set evaluation criteria quantitatively when comparing the result of each test and inspections. This study provided opportunity to increase credibility and re-assure validity of Waste Acceptance Criteria (WAC). Through the statistical analysis for deviation of measurement by comparing repository inspection with generator self-test, the quantitative acceptance criteria were set depending on specific activity of Co-60 and Cs-137. The acceptance criteria is a relative bias of KRMC result to generator result and set from low 50 % to high 150 % for Co-60, from low 30 % to 250 % for Cs-137. In this study, because the statistical analysis results of the waste drum assay are not enough representing whole range specified at WAC, an additional research that include characteristic analysis of LILW generated other birthplace should be done.

  12. The validity of world class business criteria across developed and developing countries

    Andre J. Parker

    2010-11-01

    Research purpose: To assess the validity of the general assumption in the literature that world class criteria are equally applicable worldwide. Motivation for research: The possibility exists that developing countries require an adjusted mix of world class criteria and practices to become globally competitive. Research design, approach and method: A quantitative field survey research approach was adopted. A web-enabled questionnaire was designed, covering 35 world class practices grouped under 7 world class criteria. A cross-section of the senior management from 14 developing and 20 developed country’s organisations partook in the study. Main findings: It was empirically confirmed that the majority of world class practices posited in the literature are used by participating organisations; that world class criteria do not apply equally across developed and developing countries; and that more important than country location, is the deliberate choice by an organisation’s leadership to become world class. An empirically based model of ascending to world class was proposed. Practical/managerial implications: Regardless of country location, the leadership of an organisation can make their organisation world class by applying the proposed world class model. Contribution/value add: A reliable web enabled instrument was designed that can be used to assess an organisation’s world class standing; the assumption that world class criteria are equally valid across developing and developed countries was proven partially incorrect; since becoming or being world class is also a leadership choice regardless of location.

  13. Testing the validity and acceptability of the diagnostic criteria for Hoarding Disorder: a DSM-5 survey.

    Mataix-Cols, D; Fernández de la Cruz, L; Nakao, T; Pertusa, A

    2011-12-01

    The DSM-5 Obsessive-Compulsive Spectrum Sub-Workgroup is recommending the creation of a new diagnostic category named Hoarding Disorder (HD). The validity and acceptability of the proposed diagnostic criteria have yet to be formally tested. Obsessive-compulsive disorder/hoarding experts and random members of the American Psychiatric Association (APA) were shown eight brief clinical vignettes (four cases meeting criteria for HD, three with hoarding behaviour secondary to other mental disorders, and one with subclinical hoarding behaviour) and asked to decide the most appropriate diagnosis in each case. Participants were also asked about the perceived acceptability of the criteria and whether they supported the inclusion of HD in the main manual. Altogether, 211 experts and 48 APA members completed the survey (30% and 10% response rates, respectively). The sensitivity and specificity of the HD diagnosis and the individual criteria were high (80-90%) across various types of professionals, irrespective of their experience with hoarding cases. About 90% of participants in both samples thought the criteria would be very/somewhat acceptable for professionals and sufferers. Most experts (70%) supported the inclusion of HD in the main manual, whereas only 50% of the APA members did. The proposed criteria for HD have high sensitivity and specificity. The criteria are also deemed acceptable for professionals and sufferers alike. Training of professionals and the development and validation of semi-structured diagnostic instruments should improve diagnostic accuracy even further. A field trial is now needed to confirm these encouraging findings with real patients in real clinical settings.

  14. SEA effectiveness criteria-equally valid in all countries? The case of Italy

    Fischer, Thomas B.; Gazzola, Paola

    2006-01-01

    Recent years have seen the introduction of various sets of strategic environmental assessment (SEA) effectiveness criteria in the professional international literature. Content analysis of key international SEA publications suggest that these have been developed based on the experiences of a selected number of countries only, and to date, the question whether they are fully valid in all systems and countries world-wide has not been addressed sufficiently, yet. In this context, the paper discusses the validity of effectiveness criteria for Italy, a country from which authors have only contributed to a very limited extent to the international SEA literature. It is concluded that, particularly in the light of experiences with a 'flexible', but ineffective EIA system, in Italy SEA needs to be applied in a systematic and rigorous manner, aided by strong enforcement mechanisms

  15. Prolonged grief disorder: Psychometric validation of criteria proposed for DSM-V and ICD-11.

    Holly G Prigerson

    2009-08-01

    Full Text Available Bereavement is a universal experience, and its association with excess morbidity and mortality is well established. Nevertheless, grief becomes a serious health concern for a relative few. For such individuals, intense grief persists, is distressing and disabling, and may meet criteria as a distinct mental disorder. At present, grief is not recognized as a mental disorder in the DSM-IV or ICD-10. The goal of this study was to determine the psychometric validity of criteria for prolonged grief disorder (PGD to enhance the detection and potential treatment of bereaved individuals at heightened risk of persistent distress and dysfunction.A total of 291 bereaved respondents were interviewed three times, grouped as 0-6, 6-12, and 12-24 mo post-loss. Item response theory (IRT analyses derived the most informative, unbiased PGD symptoms. Combinatoric analyses identified the most sensitive and specific PGD algorithm that was then tested to evaluate its psychometric validity. Criteria require reactions to a significant loss that involve the experience of yearning (e.g., physical or emotional suffering as a result of the desired, but unfulfilled, reunion with the deceased and at least five of the following nine symptoms experienced at least daily or to a disabling degree: feeling emotionally numb, stunned, or that life is meaningless; experiencing mistrust; bitterness over the loss; difficulty accepting the loss; identity confusion; avoidance of the reality of the loss; or difficulty moving on with life. Symptoms must be present at sufficiently high levels at least six mo from the death and be associated with functional impairment.The criteria set for PGD appear able to identify bereaved persons at heightened risk for enduring distress and dysfunction. The results support the psychometric validity of the criteria for PGD that we propose for inclusion in DSM-V and ICD-11. Please see later in the article for Editors' Summary.

  16. Fatigue Equivalent Stress State Approach Validation in Non-conservative Criteria: a Comparative Study

    Kévin Martial Tsapi Tchoupou

    Full Text Available Abstract This paper is concerned with the fatigue prediction models for estimating the multiaxial fatigue limit. An equivalent loading approach with zero out-of-phase angles intended for fatigue limit evaluation under multiaxial loading is used. Based on experimental data found in literatures, the equivalent stress is validated in Crossland and Sines criteria and predictions compared to the predictions of existing multiaxial fatigue; results over 87 experimental items show that the equivalent stress approach is very efficient.

  17. Validation of the 2010 ACR/EULAR classification criteria for rheumatoid arthritis: slight improvement over the 1987 ACR criteria.

    Britsemmer, K.; Ursum, J.; Gerritsen, M.; Tuyl, L. van; Schaardenburg, D. van

    2011-01-01

    Abstract: Background Recently, an American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) collaboration developed new classification criteria for rheumatoid arthritis (RA). Objective:To evaluate the diagnostic and discriminative ability of these new criteria compared with

  18. Validation by simulation of a clinical trial model using the standardized mean and variance criteria.

    Abbas, Ismail; Rovira, Joan; Casanovas, Josep

    2006-12-01

    To develop and validate a model of a clinical trial that evaluates the changes in cholesterol level as a surrogate marker for lipodystrophy in HIV subjects under alternative antiretroviral regimes, i.e., treatment with Protease Inhibitors vs. a combination of nevirapine and other antiretroviral drugs. Five simulation models were developed based on different assumptions, on treatment variability and pattern of cholesterol reduction over time. The last recorded cholesterol level, the difference from the baseline, the average difference from the baseline and level evolution, are the considered endpoints. Specific validation criteria based on a 10% minus or plus standardized distance in means and variances were used to compare the real and the simulated data. The validity criterion was met by all models for considered endpoints. However, only two models met the validity criterion when all endpoints were considered. The model based on the assumption that within-subjects variability of cholesterol levels changes over time is the one that minimizes the validity criterion, standardized distance equal to or less than 1% minus or plus. Simulation is a useful technique for calibration, estimation, and evaluation of models, which allows us to relax the often overly restrictive assumptions regarding parameters required by analytical approaches. The validity criterion can also be used to select the preferred model for design optimization, until additional data are obtained allowing an external validation of the model.

  19. Validity of proposed DSM-5 diagnostic criteria for nicotine use disorder: results from 734 Israeli lifetime smokers

    Shmulewitz, D.; Wall, M.M.; Aharonovich, E.; Spivak, B.; Weizman, A.; Frisch, A.; Grant, B. F.; Hasin, D.

    2013-01-01

    Background The fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) proposes aligning nicotine use disorder (NUD) criteria with those for other substances, by including the current DSM fourth edition (DSM-IV) nicotine dependence (ND) criteria, three abuse criteria (neglect roles, hazardous use, interpersonal problems) and craving. Although NUD criteria indicate one latent trait, evidence is lacking on: (1) validity of each criterion; (2) validity of the criteria as a set; (3) comparative validity between DSM-5 NUD and DSM-IV ND criterion sets; and (4) NUD prevalence. Method Nicotine criteria (DSM-IV ND, abuse and craving) and external validators (e.g. smoking soon after awakening, number of cigarettes per day) were assessed with a structured interview in 734 lifetime smokers from an Israeli household sample. Regression analysis evaluated the association between validators and each criterion. Receiver operating characteristic analysis assessed the association of the validators with the DSM-5 NUD set (number of criteria endorsed) and tested whether DSM-5 or DSM-IV provided the most discriminating criterion set. Changes in prevalence were examined. Results Each DSM-5 NUD criterion was significantly associated with the validators, with strength of associations similar across the criteria. As a set, DSM-5 criteria were significantly associated with the validators, were significantly more discriminating than DSM-IV ND criteria, and led to increased prevalence of binary NUD (two or more criteria) over ND. Conclusions All findings address previous concerns about the DSM-IV nicotine diagnosis and its criteria and support the proposed changes for DSM-5 NUD, which should result in improved diagnosis of nicotine disorders. PMID:23312475

  20. Analysis of internal and external validity criteria for a computerized visual search task: A pilot study.

    Richard's, María M; Introzzi, Isabel; Zamora, Eliana; Vernucci, Santiago

    2017-01-01

    Inhibition is one of the main executive functions, because of its fundamental role in cognitive and social development. Given the importance of reliable and computerized measurements to assessment inhibitory performance, this research intends to analyze the internal and external criteria of validity of a computerized conjunction search task, to evaluate the role of perceptual inhibition. A sample of 41 children (21 females and 20 males), aged between 6 and 11 years old (M = 8.49, SD = 1.47), intentionally selected from a private management school of Mar del Plata (Argentina), middle socio-economic level were assessed. The Conjunction Search Task from the TAC Battery, Coding and Symbol Search tasks from Wechsler Intelligence Scale for Children were used. Overall, results allow us to confirm that the perceptual inhibition task form TAC presents solid rates of internal and external validity that make a valid measurement instrument of this process.

  1. Prospective Validation of Modified NEXUS Cervical Spine Injury Criteria in Low-risk Elderly Fall Patients

    John Tran

    2016-05-01

    Full Text Available Introduction: The National Emergency X-radiography Utilization Study (NEXUS criteria are used extensively in emergency departments to rule out C-spine injuries (CSI in the general population. Although the NEXUS validation set included 2,943 elderly patients, multiple case reports and the Canadian C-Spine Rules question the validity of applying NEXUS to geriatric populations. The objective of this study was to validate a modified NEXUS criteria in a low-risk elderly fall population with two changes: a modified definition for distracting injury and the definition of normal mentation. Methods: This is a prospective, observational cohort study of geriatric fall patients who presented to a Level I trauma center and were not triaged to the trauma bay. Providers enrolled non-intoxicated patients at baseline mental status with no lateralizing neurologic deficits. They recorded midline neck tenderness, signs of trauma, and presence of other distracting injury. Results: We enrolled 800 patients. One patient fall event was excluded due to duplicate enrollment, and four were lost to follow up, leaving 795 for analysis. Average age was 83.6 (range 65-101. The numbers in parenthesis after the negative predictive value represent confidence interval. There were 11 (1.4% cervical spine injuries. One hundred seventeen patients had midline tenderness and seven of these had CSI; 366 patients had signs of trauma to the face/neck, and 10 of these patients had CSI. Using signs of trauma to the head/neck as the only distracting injury and baseline mental status as normal alertness, the modified NEXUS criteria was 100% sensitive (CI [67.9-100] with a negative predictive value of 100 (98.7-100. Conclusion: Our study suggests that a modified NEXUS criteria can be safely applied to low-risk elderly falls.

  2. Prospective Validation of Modified NEXUS Cervical Spine Injury Criteria in Low-risk Elderly Fall Patients.

    Tran, John; Jeanmonod, Donald; Agresti, Darin; Hamden, Khalief; Jeanmonod, Rebecca K

    2016-05-01

    The National Emergency X-radiography Utilization Study (NEXUS) criteria are used extensively in emergency departments to rule out C-spine injuries (CSI) in the general population. Although the NEXUS validation set included 2,943 elderly patients, multiple case reports and the Canadian C-Spine Rules question the validity of applying NEXUS to geriatric populations. The objective of this study was to validate a modified NEXUS criteria in a low-risk elderly fall population with two changes: a modified definition for distracting injury and the definition of normal mentation. This is a prospective, observational cohort study of geriatric fall patients who presented to a Level I trauma center and were not triaged to the trauma bay. Providers enrolled non-intoxicated patients at baseline mental status with no lateralizing neurologic deficits. They recorded midline neck tenderness, signs of trauma, and presence of other distracting injury. We enrolled 800 patients. One patient fall event was excluded due to duplicate enrollment, and four were lost to follow up, leaving 795 for analysis. Average age was 83.6 (range 65-101). The numbers in parenthesis after the negative predictive value represent confidence interval. There were 11 (1.4%) cervical spine injuries. One hundred seventeen patients had midline tenderness and seven of these had CSI; 366 patients had signs of trauma to the face/neck, and 10 of these patients had CSI. Using signs of trauma to the head/neck as the only distracting injury and baseline mental status as normal alertness, the modified NEXUS criteria was 100% sensitive (CI [67.9-100]) with a negative predictive value of 100 (98.7-100). Our study suggests that a modified NEXUS criteria can be safely applied to low-risk elderly falls.

  3. Involving patient research partners has a significant impact on outcomes research: a responsive evaluation of the international OMERACT conferences.

    de Wit, M.P.T.; Abma, T.A.; Koelewijn-van Loon, M.S.; Collins, S.; Kirwan, J

    2013-01-01

    Objective: To assess the inclusion of patients as international research partners in Outcome Measures in Rheumatology (OMERACT) conferences and how this has influenced the scope and conduct of outcomes research in rheumatology. Design: A thematic content analysis of OMERACT internal documents,

  4. A systematic review of measurement properties of patient reported outcome measures in psoriatic arthritis: A GRAPPA-OMERACT initiative.

    Højgaard, Pil; Klokker, Louise; Orbai, Ana-Maria; Holmsted, Kim; Bartels, Else M; Leung, Ying Ying; Goel, Niti; de Wit, Maarten; Gladman, Dafna D; Mease, Philip; Dreyer, Lene; Kristensen, Lars E; FitzGerald, Oliver; Tillett, William; Gossec, Laure; Helliwell, Philip; Strand, Vibeke; Ogdie, Alexis; Terwee, Caroline B; Christensen, Robin

    2018-04-01

    An updated psoriatic arthritis (PsA) core outcome set (COS) for randomized controlled trials (RCTs) was endorsed at the Outcome Measures in Rheumatology (OMERACT) meeting in 2016. To synthesize the evidence on measurement properties of patient reported outcome measures (PROMs) for PsA and thereby contribute to development of a PsA core outcome measurement set (COMS) as described by the OMERACT Filter 2.0. A systematic literature search was performed in EMBASE, MEDLINE and PsycINFO on Jan 1, 2017 to identify full-text articles with an aim of assessing the measurement properties of PROMs in PsA. Two independent reviewers rated the quality of studies using the COnsensus based standards for the Selection of health Measurement INstruments (COSMIN) checklist, and performed a qualitative evidence synthesis. Fifty-five studies were included in the systematic review. Forty-four instruments and a total of 89 scales were analyzed. PROMs measuring COS domains with at least fair quality evidence for good validity and reliability (and no evidence for poor properties) included the Stockerau Activity Score for PsA (German), Psoriasis Symptom Inventory, visual analogue scale for Patient Global, 36 Item Short Form Health Survey Physical Function subscale, Health Assessment Questionnaire Disability Index, Bath Ankylosing Spondylitis Functional Index, PsA Impact of Disease questionnaire, PsA Quality of Life questionnaire, VITACORA-19, Functional Assessment of Chronic Illness Therapy Fatigue scale and Social Role Participation Questionnaire. At least one PROM with some evidence for aspects of validity and reliability was available for six of the eight mandatory domains of the PsA COS. Copyright © 2018 Elsevier Inc. All rights reserved.

  5. Validation of the Rome III criteria and alarm symptoms for recurrent abdominal pain in children.

    Gijsbers, Carolien F M; Benninga, Marc A; Schweizer, Joachim J; Kneepkens, C M Frank; Vergouwe, Yvonne; Büller, Hans A

    2014-06-01

    Rome criteria were formulated to define functional gastrointestinal disorders (Rome III criteria, 2006) excluding organic diagnoses when alarm symptoms were absent. The aims of the study were to validate the Rome III criteria as to their capacity to differentiate between organic and functional abdominal pain and to assess the role of alarm symptoms in this differentiation. During 2 years all of the patients (ages 4-16 years) presenting with recurrent abdominal pain (Apley criteria) and referred to secondary care were included. Clinical diagnoses were based on protocolized evaluation and intervention with 6-month follow-up. Alarm symptoms were registered. Rome III criteria for functional pain syndromes were assigned independently. Descriptive statistical analyses were performed. In 200 patients (87 boys, mean age 8.8 years), organic (17%), functional (40%), combined organic and functional (9%), spontaneous recovery (27%), and other (8%) clinical diagnoses were established. Alarm symptoms were found in 57.5% (organic causes 56%, functional causes 61%). The evaluation for Rome symptom clusters revealed symptoms of irritable bowel syndrome in 27%, functional dyspepsia in 15%, functional abdominal pain in 28%, functional abdominal pain syndrome in 14.5%, and no pain syndrome in 15.5%. Rome diagnoses, based on symptoms and absence of alarm symptoms, predicted functional clinical diagnosis with sensitivity 0.35 (95% confidence interval 0.27-0.43), specificity 0.60 (0.46-0.73), positive predictive value 0.71 (0.61-0.82), and negative predictive value of 0.24 (0.17-0.32). The Rome III criteria for abdominal pain are not specific enough to rule out organic causes. Alarm symptoms do not differentiate between organic and functional abdominal pain.

  6. Fisk-based criteria to support validation of detection methods for drinking water and air.

    MacDonell, M.; Bhattacharyya, M.; Finster, M.; Williams, M.; Picel, K.; Chang, Y.-S.; Peterson, J.; Adeshina, F.; Sonich-Mullin, C.; Environmental Science Division; EPA

    2009-02-18

    This report was prepared to support the validation of analytical methods for threat contaminants under the U.S. Environmental Protection Agency (EPA) National Homeland Security Research Center (NHSRC) program. It is designed to serve as a resource for certain applications of benchmark and fate information for homeland security threat contaminants. The report identifies risk-based criteria from existing health benchmarks for drinking water and air for potential use as validation targets. The focus is on benchmarks for chronic public exposures. The priority sources are standard EPA concentration limits for drinking water and air, along with oral and inhalation toxicity values. Many contaminants identified as homeland security threats to drinking water or air would convert to other chemicals within minutes to hours of being released. For this reason, a fate analysis has been performed to identify potential transformation products and removal half-lives in air and water so appropriate forms can be targeted for detection over time. The risk-based criteria presented in this report to frame method validation are expected to be lower than actual operational targets based on realistic exposures following a release. Note that many target criteria provided in this report are taken from available benchmarks without assessing the underlying toxicological details. That is, although the relevance of the chemical form and analogues are evaluated, the toxicological interpretations and extrapolations conducted by the authoring organizations are not. It is also important to emphasize that such targets in the current analysis are not health-based advisory levels to guide homeland security responses. This integrated evaluation of chronic public benchmarks and contaminant fate has identified more than 200 risk-based criteria as method validation targets across numerous contaminants and fate products in drinking water and air combined. The gap in directly applicable values is

  7. Fuzzy decision-making: a new method in model selection via various validity criteria

    Shakouri Ganjavi, H.; Nikravesh, K.

    2001-01-01

    Modeling is considered as the first step in scientific investigations. Several alternative models may be candida ted to express a phenomenon. Scientists use various criteria to select one model between the competing models. Based on the solution of a Fuzzy Decision-Making problem, this paper proposes a new method in model selection. The method enables the scientist to apply all desired validity criteria, systematically by defining a proper Possibility Distribution Function due to each criterion. Finally, minimization of a utility function composed of the Possibility Distribution Functions will determine the best selection. The method is illustrated through a modeling example for the A verage Daily Time Duration of Electrical Energy Consumption in Iran

  8. The Validity of the New York Radiological Grading Criteria in Diagnosing Sacroiliitis by Computed Tomography

    Geijer, M.; Gadeholt Goethlin, G.; Goethlin, J.H. (Dept. of Diagnostic Radiology, Sahlgrenska Univ. Hospital, Goeteborg (Sweden))

    2009-07-15

    Background: Sacroiliitis in ankylosing spondylitis has frequently been graded radiographically using the New York (NY) criteria, which also have been applied in computed tomography (CT). Purpose: To validate the grading of the NY criteria in CT of the sacroiliac joints. Material and Methods: With the aid of the NY criteria, assessment of inflammatory and degenerative changes was made in 1304 CT studies. Assessment included erosions, the distribution, type, and width of sclerosis, and the involvement of the joints in sacroiliitis, as well as of normal anatomic variants such as joint space width and shape. Results: There was definite radiological sacroiliitis in 420 joints in 251 patients. Among these, more than two-thirds of the joint was involved in 71.0% of the affected joints. Sclerosis of the ilium was much more prevalent than sacral sclerosis. With increasing NY grade, iliac sclerosis, width, and extent increased, transition from sclerosis to normal bone became indistinct, and the structure of sclerosis was more inhomogeneous. Erosions of the joint surfaces were localized predominantly on the iliac side. Conclusion: Only erosions seem to be a valid solitary diagnostic sign. Solitary erosions need supplemental evidence from other inflammatory signs. Inflammatory sclerosis may be distinguished from degenerative sclerosis, and can sometimes support early diagnosis. Joint space width, joint shape, bone mineral content, or enthesopathy have no place in sacroiliitis diagnosis on CT. The NY criteria are not ideal for use with CT. A practical classification of sacroiliitis on CT is proposed, with a grading of no disease, suspected disease, and definite disease

  9. Design and validation of standardized clinical and functional remission criteria in schizophrenia

    Mosolov, Sergey N; Potapov, Andrey V; Ushakov, Uriy V; Shafarenko, Aleksey A; Kostyukova, Anastasiya B

    2014-01-01

    Background International Remission Criteria (IRC) for schizophrenia were developed recently by a group of internationally known experts. The IRC detect only 10%–30% of cases and do not cover the diversity of forms and social functioning. Our aim was to design a more applicable tool and validate its use – the Standardized Clinical and Functional Remission Criteria (SCFRC). Methods We used a 6-month follow-up study of 203 outpatients from two Moscow centers and another further sample of stable patients from a 1-year controlled trial of atypical versus typical medication. Diagnosis was confirmed by International Classification of Diseases Version 10 (ICD10) criteria and the Mini-International Neuropsychiatric Interview (MINI). Patients were assessed by the Positive and Negative Syndrome Scale, including intensity threshold, and further classified using the Russian domestic remission criteria and the level of social and personal functioning, according to the Personal and Social Performance Scale (PSP). The SCFRC were formulated and were validated by a data reanalysis on the first population sample and on a second independent sample (104 patients) and in an open-label prospective randomized 12-month comparative study of risperidone long-acting injectable (RLAI) versus olanzapine. Results Only 64 of the 203 outpatients (31.5%) initially met the IRC, and 53 patients (26.1%) met the IRC after 6 months, without a change in treatment. Patients who were in remission had episodic and progressive deficit (39.6%), or remittent (15%) paranoid schizophrenia, or schizoaffective disorder (17%). In addition, 105 patients of 139 (51.7%), who did not meet symptomatic IRC, remained stable within the period. Reanalysis of data revealed that 65.5% of the patients met the SCFRC. In the controlled trial, 70% of patients in the RLAI group met the SCFRC and only 19% the IRC. In the routine treatment group, 55.9% met the SCFRC and only 5.7% the IRC. Results of the further independent

  10. The Use of the OMERACT Ultrasound Tenosynovitis Scoring System in Multicenter Clinical Trials.

    Ammitzbøll-Danielsen, Mads; Østergaard, Mikkel; Naredo, Esperanza; Iagnocco, Annamaria; Möller, Ingrid; D'Agostino, Maria-Antonietta; Gandjbakhch, Frédérique; Terslev, Lene

    2018-02-01

    To test the sensitivity to change of the Outcome Measures in Rheumatology Clinical Trials (OMERACT) ultrasound (US) scoring system for tenosynovitis when applied in a multicenter design. RA patients with US-verified tenosynovitis were recruited when scheduled for treatment intensification. Tenosynovitis was assessed at baseline, and 3 and 6 months followup, using the semiquantitative OMERACT scoring system. Expressed in median (25th; 75th percentiles), the overall greyscale and Doppler score decreased significantly from baseline at 4 (2; 7) and 3 (2; 6), to 6 months at 2 (0; 3) and 0 (0; 1, p The OMERACT US scoring system for tenosynovitis showed high responsiveness, supporting its use for diagnosing and monitoring tenosynovitis in multicenter trials.

  11. Development and validation of the mindfulness-based interventions - teaching assessment criteria (MBI:TAC).

    Crane, Rebecca S; Eames, Catrin; Kuyken, Willem; Hastings, Richard P; Williams, J Mark G; Bartley, Trish; Evans, Alison; Silverton, Sara; Soulsby, Judith G; Surawy, Christina

    2013-12-01

    The assessment of intervention integrity is essential in psychotherapeutic intervention outcome research and psychotherapist training. There has been little attention given to it in mindfulness-based interventions research, training programs, and practice. To address this, the Mindfulness-Based Interventions: Teaching Assessment Criteria (MBI:TAC) was developed. This article describes the MBI:TAC and its development and presents initial data on reliability and validity. Sixteen assessors from three centers evaluated teaching integrity of 43 teachers using the MBI:TAC. Internal consistency (α = .94) and interrater reliability (overall intraclass correlation coefficient = .81; range = .60-.81) were high. Face and content validity were established through the MBI:TAC development process. Data on construct validity were acceptable. Initial data indicate that the MBI:TAC is a reliable and valid tool. It can be used in Mindfulness-Based Stress Reduction/Mindfulness-Based Cognitive Therapy outcome evaluation research, training and pragmatic practice settings, and in research to assess the impact of teaching integrity on participant outcome.

  12. The Spirit of OMERACT: Q Methodology Analysis of Conference Characteristics Valued by Delegates.

    Flurey, Caroline A; Kirwan, John R; Hadridge, Phillip; Richards, Pamela; Grosskleg, Shawna; Tugwell, Peter S

    2015-10-01

    To identify the major features of OMERACT meetings as valued by frequent participants and to explore whether there are groups of participants with different opinions. Using Q methodology (a qualitative and quantitative approach to grouping people according to subjective opinion), participants (who attended more than 1 OMERACT conference) sorted 66 statements relating to the "spirit of OMERACT" according to level of agreement across a normal distribution grid. Data were examined using Q factor analysis. Of 226 potential participants, 105 responded (46%). All participants highly ranked the focus on global standardization of methods, outcome measures, data-driven research, methodological discussion, and international collaboration. Four factors describing the "spirit of OMERACT" were identified: "Evidence not eminence" (n = 31) valued the data- and evidence-driven research above personality and status; "Collaboration and collegiality" (n = 19) valued the international and cross-stakeholder collaboration, interaction, and collegiality; "Equal voices, equal votes, common goals" (n = 12) valued equality in discussion and voting, with everyone striving toward the same goal; "principles and product, not process" (n = 8) valued the principles of focusing on outcome measures and the product of guiding clinical trials, but were unsure whether the process is necessary to reach this. The factors did not segregate different stakeholder groups. Delegates value different elements of OMERACT, and thus the "spirit of OMERACT" encompasses evidence-based research, collaboration, and equality, although a small group are unsure whether the process is necessary to achieve the end result. Q methodology may prove useful for conference organizers to identify their delegates' different needs to tailor conference content.

  13. Prospective validation of criteria, including age, for safe, nonsurgical management of the ruptured spleen

    Smith, J.S. Jr.; Wengrovitz, M.A.; DeLong, B.S. (Pennsylvania State University College of Medicine, Hershey (United States))

    1992-09-01

    One hundred twelve cases of blunt splenic rupture were prospectively entered (October 1987-October 1991) into surgical or nonsurgical management groups using these criteria for the nonsurgical group: hemodynamic stability-age less than 55 years-CT scan appearance of grade I, II, or III injury-absence of concomitant injuries precluding abdominal assessment+absence of other documented abdominal injuries. All ages were included and AAST injury scaling was used. Patients were grouped from the trauma room. The surgical treatment group included 66 patients (49 splenectomies, 17 splenorraphies). These patients were generally older and more severely injured, required more transfused blood, and a longer ICU stay. The nonsurgical group included 46 patients with 33 older than 14 years. There were 3 patients over the age of 55 years inappropriately included in this group, and nonsurgical therapy failed in all three. Statistical analysis (chi 2) showed that more splenic injuries were observed and more spleens were saved with these criteria applied prospectively compared with a previous retrospective series in the same institution. The series had a success rate of 93%, and validates the criteria used for safe, nonsurgical management of the ruptured spleen and adds a new criterion: a maximum age of 55 years.

  14. Criteria for validation and selection of cognitive tests for investigating the effects of foods and nutrients.

    de Jager, Celeste A; Dye, Louise; de Bruin, Eveline A; Butler, Laurie; Fletcher, John; Lamport, Daniel J; Latulippe, Marie E; Spencer, Jeremy P E; Wesnes, Keith

    2014-03-01

    This review is an output of the International Life Sciences Institute (ILSI) Europe Marker Initiative, which aims to identify evidence-based criteria for selecting adequate measures of nutrient effects on health through comprehensive literature review. Experts in cognitive and nutrition sciences examined the applicability of these proposed criteria to the field of cognition with respect to the various cognitive domains usually assessed to reflect brain or neurological function. This review covers cognitive domains important in the assessment of neuronal integrity and function, commonly used tests and their state of validation, and the application of the measures to studies of nutrition and nutritional intervention trials. The aim is to identify domain-specific cognitive tests that are sensitive to nutrient interventions and from which guidance can be provided to aid the application of selection criteria for choosing the most suitable tests for proposed nutritional intervention studies using cognitive outcomes. The material in this review serves as a background and guidance document for nutritionists, neuropsychologists, psychiatrists, and neurologists interested in assessing mental health in terms of cognitive test performance and for scientists intending to test the effects of food or food components on cognitive function.

  15. Prospective validation of criteria, including age, for safe, nonsurgical management of the ruptured spleen

    Smith, J.S. Jr.; Wengrovitz, M.A.; DeLong, B.S.

    1992-01-01

    One hundred twelve cases of blunt splenic rupture were prospectively entered (October 1987-October 1991) into surgical or nonsurgical management groups using these criteria for the nonsurgical group: hemodynamic stability-age less than 55 years-CT scan appearance of grade I, II, or III injury-absence of concomitant injuries precluding abdominal assessment+absence of other documented abdominal injuries. All ages were included and AAST injury scaling was used. Patients were grouped from the trauma room. The surgical treatment group included 66 patients (49 splenectomies, 17 splenorraphies). These patients were generally older and more severely injured, required more transfused blood, and a longer ICU stay. The nonsurgical group included 46 patients with 33 older than 14 years. There were 3 patients over the age of 55 years inappropriately included in this group, and nonsurgical therapy failed in all three. Statistical analysis (chi 2) showed that more splenic injuries were observed and more spleens were saved with these criteria applied prospectively compared with a previous retrospective series in the same institution. The series had a success rate of 93%, and validates the criteria used for safe, nonsurgical management of the ruptured spleen and adds a new criterion: a maximum age of 55 years

  16. The 2018 Definition of Periprosthetic Hip and Knee Infection: An Evidence-Based and Validated Criteria.

    Parvizi, Javad; Tan, Timothy L; Goswami, Karan; Higuera, Carlos; Della Valle, Craig; Chen, Antonia F; Shohat, Noam

    2018-05-01

    The introduction of the Musculoskeletal Infection Society (MSIS) criteria for periprosthetic joint infection (PJI) in 2011 resulted in improvements in diagnostic confidence and research collaboration. The emergence of new diagnostic tests and the lessons we have learned from the past 7 years using the MSIS definition, prompted us to develop an evidence-based and validated updated version of the criteria. This multi-institutional study of patients undergoing revision total joint arthroplasty was conducted at 3 academic centers. For the development of the new diagnostic criteria, PJI and aseptic patient cohorts were stringently defined: PJI cases were defined using only major criteria from the MSIS definition (n = 684) and aseptic cases underwent one-stage revision for a noninfective indication and did not fail within 2 years (n = 820). Serum C-reactive protein (CRP), D-dimer, erythrocyte sedimentation rate were investigated, as well as synovial white blood cell count, polymorphonuclear percentage, leukocyte esterase, alpha-defensin, and synovial CRP. Intraoperative findings included frozen section, presence of purulence, and isolation of a pathogen by culture. A stepwise approach using random forest analysis and multivariate regression was used to generate relative weights for each diagnostic marker. Preoperative and intraoperative definitions were created based on beta coefficients. The new definition was then validated on an external cohort of 222 patients with PJI who subsequently failed with reinfection and 200 aseptic patients. The performance of the new criteria was compared to the established MSIS and the prior International Consensus Meeting definitions. Two positive cultures or the presence of a sinus tract were considered as major criteria and diagnostic of PJI. The calculated weights of an elevated serum CRP (>1 mg/dL), D-dimer (>860 ng/mL), and erythrocyte sedimentation rate (>30 mm/h) were 2, 2, and 1 points, respectively. Furthermore, elevated

  17. Update on research and future directions of the OMERACT MRI inflammatory arthritis group

    Conaghan, Philip G; McQueen, Fiona M; Bird, Paul

    2011-01-01

    of this score will require more PsA imaging datasets. As well, due to improved image resolution since the development of the original rheumatoid arthritis MRI scoring system (RAMRIS), the Task Force has worked on semiquantitative assessment of joint space narrowing, and developed a reliable method......The OMERACT Magnetic Resonance Imaging (MRI) Task Force has developed and evolved the psoriatic arthritis MRI score (PsAMRIS) over the last few years, and at OMERACT 10, presented longitudinal evaluation by multiple readers, using PsA datasets obtained from extremity MRI magnets. Further evaluation...

  18. Diagnosis of Guillain-Barré syndrome in children and validation of the Brighton criteria.

    Roodbol, Joyce; de Wit, Marie-Claire Y; van den Berg, Bianca; Kahlmann, Vivienne; Drenthen, Judith; Catsman-Berrevoets, Coriene E; Jacobs, Bart C

    2017-05-01

    To describe the key diagnostic features of pediatric Guillain-Barré syndrome (GBS) and validate the Brighton criteria. Retrospective cohort study of all children (Children's Hospital, Erasmus MC, Rotterdam. Clinical information was collected and the sensitivity of the Brighton criteria was calculated. 67 children (35 boys) were included, with a median age of 5.0 years [interquartile range (IQR) 3.0-10.0 years]. Bilateral limb weakness was present at hospital admission in 93% of children, and at nadir in all patients. Children presented with tetraparesis in 70% or with paraparesis in 23%. Reduced reflexes in paretic limbs were observed at hospital admission in 82% and during follow-up in all children. The progressive phase lasted median 6 days (IQR 3-8 days) and less than 4 weeks in all children. A monophasic disease course was seen in 97%, including 5 children with a treatment-related fluctuation. Two children had a later relapse at 9 weeks and 19 weeks after onset. 77% of the children showed an elevated protein level in CSF. Nerve conduction studies showed evidence for a poly(radiculo)neuropathy in 91% of the children. 46 children had a complete data set, the sensitivity of the Brighton criteria level 1 was 72% (95% CI 57-84) and 96% (95% CI 85-99) for level 2 and 98% (95% CI 88-100) for level 3. The majority of the pediatric GBS patients presented in this cohort fulfilled the current diagnostic criteria.

  19. Development and Validation of the Somatic Symptom Disorder-B Criteria Scale (SSD-12).

    Toussaint, Anne; Murray, Alexandra M; Voigt, Katharina; Herzog, Annabel; Gierk, Benjamin; Kroenke, Kurt; Rief, Winfried; Henningsen, Peter; Löwe, Bernd

    2016-01-01

    To develop and validate a new self-report questionnaire for the assessment of the psychological features of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition somatic symptom disorder. The Somatic Symptom Disorder-B Criteria Scale (SSD-12) was developed in several steps from an initial pool of 98 items. The SSD-12 is composed of 12 items; each of the three psychological subcriteria is measured by four items. In a cross-sectional study, the SSD-12 was administered to 698 patients (65.8% female, mean [standard deviation] age = 38.79 [14.15] years) from a psychosomatic outpatient clinic. Item and scale characteristics as well as measures of reliability and validity were determined. The SSD-12 has good item characteristics and excellent reliability (Cronbach α = .95). Confirmatory factor analyses suggested that a three-factorial structure that reflects the three psychological criteria interpreted as cognitive, affective, and behavioral aspects (n = 663, Comparative Fit Index > 0.99, Tucker-Lewis Index > 0.99, Root Mean Square Error of Approximation = 0.06, 90% confidence interval = 0.01-0.08). SSD-12 total sum score was significantly associated with somatic symptom burden (r = 0.47, p psychological symptom burden reported higher general physical and mental health impairment and significantly higher health care use. The SSD-12 is the first self-report questionnaire that operationalizes the new psychological characteristics of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition somatic symptom disorder. Initial assessment indicates that the SSD-12 has sufficient reliability and validity to warrant further testing in both research and clinical settings.

  20. Design and validation of standardized clinical and functional remission criteria in schizophrenia

    Mosolov SN

    2014-01-01

    Full Text Available Sergey N Mosolov,1 Andrey V Potapov,1 Uriy V Ushakov,2 Aleksey A Shafarenko,1 Anastasiya B Kostyukova11Department of Mental Disorders Therapy, Moscow Research Institute of Psychiatry, Moscow, Russia; 2Moscow Psychiatric Outpatient Services #21, Moscow, RussiaBackground: International Remission Criteria (IRC for schizophrenia were developed recently by a group of internationally known experts. The IRC detect only 10%–30% of cases and do not cover the diversity of forms and social functioning. Our aim was to design a more applicable tool and validate its use – the Standardized Clinical and Functional Remission Criteria (SCFRC.Methods: We used a 6-month follow-up study of 203 outpatients from two Moscow centers and another further sample of stable patients from a 1-year controlled trial of atypical versus typical medication. Diagnosis was confirmed by International Classification of Diseases Version 10 (ICD10 criteria and the Mini-International Neuropsychiatric Interview (MINI. Patients were assessed by the Positive and Negative Syndrome Scale, including intensity threshold, and further classified using the Russian domestic remission criteria and the level of social and personal functioning, according to the Personal and Social Performance Scale (PSP. The SCFRC were formulated and were validated by a data reanalysis on the first population sample and on a second independent sample (104 patients and in an open-label prospective randomized 12-month comparative study of risperidone long-acting injectable (RLAI versus olanzapine.Results: Only 64 of the 203 outpatients (31.5% initially met the IRC, and 53 patients (26.1% met the IRC after 6 months, without a change in treatment. Patients who were in remission had episodic and progressive deficit (39.6%, or remittent (15% paranoid schizophrenia, or schizoaffective disorder (17%. In addition, 105 patients of 139 (51.7%, who did not meet symptomatic IRC, remained stable within the period. Reanalysis of

  1. The OMERACT MRI in Arthritis Working Group - Update on Status and Future Research Priorities

    Østergaard, Mikkel; Bird, Paul; Gandjbakhch, Frédérique

    2015-01-01

    OBJECTIVE: To provide an update on the status and future research priorities of the Outcome Measures in Rheumatology (OMERACT) magnetic resonance imaging (MRI) in arthritis working group. METHODS: A summary is provided of the activities of the group within rheumatoid arthritis (RA), psoriatic...

  2. The longitudinal reliability and responsiveness of the OMERACT Hand Osteoarthritis Magnetic Resonance Imaging Scoring System (HOAMRIS)

    Haugen, Ida K.; Eshed, Iris; Gandjbakhch, Frederique

    2015-01-01

    Objective. To evaluate the interreader reliability of change scores and the responsiveness of the OMERACT Hand Osteoarthritis (OA) Magnetic Resonance Image (MRI) Scoring System (HOAMRIS). Methods. Paired MRI (baseline and 5-yr followup) from 20 patients with hand OA were scored with known time se...

  3. An OMERACT Initiative Toward Consensus to Identify and Characterize Candidate Contextual Factors

    Finger, Monika E; Boonen, Annelies; Woodworth, Thasia G

    2017-01-01

    OBJECTIVE: The importance of contextual factors (CF) for appropriate patient-specific care is widely acknowledged. However, evidence in clinical trials on how CF influence outcomes remains sparse. The 2014 Outcome Measures in Rheumatology (OMERACT) Handbook introduced the role of CF in outcome as...

  4. The OMERACT-RAMRIS Rheumatoid Arthritis Magnetic Resonance Imaging Joint Space Narrowing Score

    Møller Døhn, Uffe; Conaghan, Philip G; Eshed, Iris

    2014-01-01

    To test the intrareader and interreader reliability of assessment of joint space narrowing (JSN) in rheumatoid arthritis (RA) wrist and metacarpophalangeal (MCP) joints on magnetic resonance imaging (MRI) and computed tomography (CT) using the newly proposed OMERACT-RAMRIS JSN scoring method...

  5. Validity criteria for the diagnosis of fatty liver by M probe-based controlled attenuation parameter.

    Wong, Vincent Wai-Sun; Petta, Salvatore; Hiriart, Jean-Baptiste; Cammà, Calogero; Wong, Grace Lai-Hung; Marra, Fabio; Vergniol, Julien; Chan, Anthony Wing-Hung; Tuttolomondo, Antonino; Merrouche, Wassil; Chan, Henry Lik-Yuen; Le Bail, Brigitte; Arena, Umberto; Craxì, Antonio; de Lédinghen, Victor

    2017-09-01

    Controlled attenuation parameter (CAP) can be performed together with liver stiffness measurement (LSM) by transient elastography (TE) and is often used to diagnose fatty liver. We aimed to define the validity criteria of CAP. CAP was measured by the M probe prior to liver biopsy in 754 consecutive patients with different liver diseases at three centers in Europe and Hong Kong (derivation cohort, n=340; validation cohort, n=414; 101 chronic hepatitis B, 154 chronic hepatitis C, 349 non-alcoholic fatty liver disease, 37 autoimmune hepatitis, 49 cholestatic liver disease, 64 others; 277 F3-4; age 52±14; body mass index 27.2±5.3kg/m 2 ). The primary outcome was the diagnosis of fatty liver, defined as steatosis involving ≥5% of hepatocytes. The area under the receiver-operating characteristics curve (AUROC) for CAP diagnosis of fatty liver was 0.85 (95% CI 0.82-0.88). The interquartile range (IQR) of CAP had a negative correlation with CAP (r=-0.32, psteatosis was lower among patients with body mass index ≥30kg/m 2 and F3-4 fibrosis. The validity of CAP for the diagnosis of fatty liver is lower if the IQR of CAP is ≥40dB/m. Lay summary: Controlled attenuation parameter (CAP) is measured by transient elastography (TE) for the detection of fatty liver. In this large study, using liver biopsy as a reference, we show that the variability of CAP measurements based on its interquartile range can reflect the accuracy of fatty liver diagnosis. In contrast, other clinical factors such as adiposity and liver enzyme levels do not affect the performance of CAP. Copyright © 2017 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

  6. Criteria of validity in the measurement of shearing fracture toughness; Gueltigkeitskriterien zur Bestimmung von Scherbruchzaehigkeiten

    Hiese, W

    2000-01-01

    The investigations aimed at the development of criteria for measuring valid shearing fracture toughness data K{sub IIc} in analogy to the measurement of mode-I fracture toughness K{sub Ie}. Details are presented, and practical recommendations are given. [German] Die Brucheigenschaften von Werkstoffen werden ueblicherweise unter Zugbeanspruchungsbedingungen (Mode-I) bestimmt. Im Anwendungsbereich der linear-elastischen Bruchmechanik bzw. des Kleinbereichsfliessens geschieht dieses in Form der Bruchzaehigkeit K{sub Ic}. Es existieren entsprechende Richtlinien zur Durchfuehrung des Tests sowie zur Registrierung und Auswertung der Daten. Diese Kriterien sind in Standards festgelegt. Empfehlungen zur Bestimmung der Bruchzaehigkeit K{sub IIc} unter ebener Scherbelastung (Mode-II) fuer Werkstoffe mit im wesentlichen linear-elastischem Verhalten existieren nicht. Im Rahmen dieser Arbeit werden durch den Vergleich der Groesse der plastischen Rissspitzenzonen im Verhaeltnis zu den Abmessungen von Probe bzw. Bauteil Kriterien zur Messung gueltiger Scherbruchzaehigkeiten K{sub IIc} analog zur Messung der Mode-I-Bruchzaehigkeit K{sub Ic} entwickelt. Der Groessenvergleich der plastischen Rissspitzenzonen fuer beide Beanspruchungsarten zeigt unter aequivalenten Beanspruchungen, d.h. K{sub II}=K{sub I}, dass bei Mode-II beanspruchten Rissen die plastischen Zonen groesser, aber die Differenzen in der Groesse der plastischen Zonen fuer die Zustaende ebener Spannung und ebener Dehnung kleiner sind als unter entsprechenden Mode-I-Beanspruchungen.

  7. Proposal for Requirement Validation Criteria and Method Based on Actor Interaction

    Hattori, Noboru; Yamamoto, Shuichiro; Ajisaka, Tsuneo; Kitani, Tsuyoshi

    We propose requirement validation criteria and a method based on the interaction between actors in an information system. We focus on the cyclical transitions of one actor's situation against another and clarify observable stimuli and responses based on these transitions. Both actors' situations can be listed in a state transition table, which describes the observable stimuli or responses they send or receive. Examination of the interaction between both actors in the state transition tables enables us to detect missing or defective observable stimuli or responses. Typically, this method can be applied to the examination of the interaction between a resource managed by the information system and its user. As a case study, we analyzed 332 requirement defect reports of an actual system development project in Japan. We found that there were a certain amount of defects regarding missing or defective stimuli and responses, which can be detected using our proposed method if this method is used in the requirement definition phase. This means that we can reach a more complete requirement definition with our proposed method.

  8. What is required for the validation of in vitro assays for predicting contaminant relative bioavailability? Considerations and criteria

    Juhasz, Albert L.; Basta, Nicholas T.; Smith, Euan

    2013-01-01

    A number of studies have shown the potential of in vitro assays to predict contaminant in vivo relative bioavailability in order to refine human health exposure assessment. Although the term ‘validated’ has been used to describe the goodness of fit between in vivo and in vitro observations, its misuse has arisen from semantic considerations in addition to the lack of defined criteria for establishing performance validation. While several internal validation methods may be utilised, performance validation should preferably focus on assessing the agreement of model predictions with a set of data which are independent of those used to construct the model. In order to achieve robust validated predictive models, a number of parameters (e.g. size of data set, source of independent soils, contaminant concentration range, animal model, relative bioavailability endpoint) need to be considered in addition to defined criteria for establishing performance validation which are currently lacking. -- Defined criteria for establishing in vivo–in vitro performance validation are required in order to ensure robust, defensible predictive models for human health exposure assessment

  9. Live birth rates in the different combinations of the Bologna criteria poor ovarian responders: a validation study.

    La Marca, Antonio; Grisendi, Valentina; Giulini, Simone; Sighinolfi, Giovanna; Tirelli, Alessandra; Argento, Cindy; Re, Claudia; Tagliasacchi, Daniela; Marsella, Tiziana; Sunkara, Sesh Kamal

    2015-06-01

    to compare the baseline characteristics and chance of live birth in the different categories of poor responders identified by the combinations of the Bologna criteria and establish whether these groups comprise a homogenous population. database containing clinical and laboratory information on IVF treatment cycles carried out at the Mother-Infant Department of the University Hospital of Modena between year 2007 and 2011 was analysed. This data was collected prospectively and recorded in the registered database of the fertility centre. Eight hundred and thirty women fulfilled the inclusion/ exclusion criteria of the study and 210 women fulfilled the Bologna criteria definition for poor ovarian response (POR). Five categories of poor responders were identified by different combinations of the Bologna criteria. There were no significant differences in female age, AFC, AMH, cycle cancellation rate and number of retrieved oocytes between the five groups. The live birth rate ranged between 5.5 and 7.4 % and was not statistically different in the five different categories of women defined as poor responders according to the Bologna criteria. The study demonstrates that the different groups of poor responders based on the Bologna criteria have similar IVF outcomes. This information validates the Bologna criteria definition as women having a uniform poor prognosis and also demonstrates that the Bologna criteria poor responders in the various subgroups represent a homogenous population with similar pre-clinical and clinical outcomes.

  10. Incremental Validity of the MMPI-2 PSY-5 Scales in Assessing Self-Reported Personality Disorder Criteria

    Wygant, Dustin B.; Sellbom, Martin; Graham, John R.; Schenk, Paul W.

    2006-01-01

    The Minnesota Multiphasic Personality Inventory-2 (MMPI-2) Personality Psychopathology-Five (PSY-5) scales were developed to measure abnormal personality symptomatology. The present study examines the incremental validity of the PSY-5 scales beyond the clinical and content scales in assessing criteria associated with personality disorders. The…

  11. Using multiple and specific criteria to assess the predictive validity of the Big Five personality factors on academic performance.

    Kappe, F.R.; van der Flier, H.

    2010-01-01

    Multiple and specific academic performance criteria were used to examine the predictive validity of the Big Five personality traits. One hundred thirty-three students in a college of higher learning in The Netherlands participated in a naturally occurring field study. The results of the NEO-FFI were

  12. Validity of Evidence-Derived Criteria for Reactive Attachment Disorder: Indiscriminately Social/Disinhibited and Emotionally Withdrawn/Inhibited Types

    Gleason, Mary Margaret; Fox, Nathan A.; Drury, Stacy; Smyke, Anna; Egger, Helen L.; Nelson, Charles A., III; Gregas, Matthew C.; Zeanah, Charles H.

    2011-01-01

    Objective: This study examined the validity of criteria for indiscriminately social/disinhibited and emotionally withdrawn/inhibited reactive attachment disorder (RAD). Method: As part of a longitudinal intervention trial of previously institutionalized children, caregiver interviews and direct observational measurements provided continuous and…

  13. Is there any evidence for the validity of diagnostic criteria used for accommodative and nonstrabismic binocular dysfunctions?

    Pilar Cacho-Martínez

    2014-01-01

    Conclusions: Scientific literature reveals differences between authors according to diagnostic criteria for accommodative and nonstrabismic binocular dysfunctions. Diagnostic accuracy studies show that there is only certain evidence for accommodative conditions. For binocular anomalies there is only evidence about a validated questionnaire for convergence insufficiency with no data of diagnostic accuracy.

  14. Validation of subclavian duplex velocity criteria to grade severity of subclavian artery stenosis.

    Mousa, Albeir Y; Morkous, Ramez; Broce, Mike; Yacoub, Michael; Sticco, Andrew; Viradia, Ravi; Bates, Mark C; AbuRahma, Ali F

    2017-06-01

    Validation of subclavian duplex ultrasound velocity criteria (SDUS VC) to grade the severity of subclavian artery stenosis has not been established or systematically studied. Currently, there is a paucity of published literature and lack of practitioner consensus for how subclavian duplex velocity findings should be interpreted in patients with subclavian artery stenosis. The objective of the present study was to validate SDUS measurements using subclavian conventional or computed tomography angiogram (subclavian angiogram [SA])-derived measurements. Secondary objectives included measuring the correlation between SDUS peak systolic velocities and SA measurements, and to determine the optimal cutoff value for predicting significant stenosis (>70%). This is a retrospective review of all patients with suspected subclavian artery stenosis and a convenience sample of carotid artery patients who underwent SDUS and SA from May 1999 to July 2013. SA reference vessel and intralesion minimal lumen diameters were measured and compared with SDUS velocities obtained within 3 months of the imaging study. Percent stenosis was calculated using the North American Symptomatic Carotid Endarterectomy Trial method for detecting stenosis in a sufficiently large cohort. Receiver operating characteristic curves was generated for SDUS VC to predict >70% stenosis. Velocity cutoff points were determined with equal weighting of sensitivity and specificity. We examined 268 arteries for 177 patients. The majority of the arteries were for female patients (52.5%) with a mean age of 66.7 ± 11.1 years. Twenty-three arteries had retrograde vertebral artery flow and excluded from further analysis. For the remaining 245 arteries, the average peak systolic velocity was 212.6 ± 110.7 cm/s, with a range of 45-626 cm/s. Average stenosis was 25.8% ± 28.2%, with a range of 0% to 100%. Following receiver operating characteristic analysis, we found a cutoff value of >240 cm/s to be most predictive

  15. Validating a Methodology for Establishing a Criteria and Proficiency Levels in Surgical Skills Simulators

    Heinrichs, LeRoy; Lukoff, Brian; Youngblood, Patricia; Dev, Parvati; Shavelson, Richard

    2006-01-01

    .... To establish training criteria, we have assessed the performance of 18 experienced laparoscopic surgeons basic technical surgical skills of recorded electronically in 26 basic skills modules selected...

  16. Impact of applying the more stringent validation criteria of the revised European Society of Hypertension International Protocol 2010 on earlier validation studies.

    Stergiou, George S; Karpettas, Nikos; Atkins, Neil; O'Brien, Eoin

    2011-04-01

    Since 2002 when the European Society of Hypertension International Protocol (ESH-IP) was published it has become the preferred protocol for validating blood pressure monitors worldwide. In 2010, a revised version of the ESH-IP with more stringent criteria was published. This study assesses the impact of applying the revised ESH-IP criteria. A systematic literature review of ESH-IP studies reported between 2002 and 2010 was conducted. The impact of applying the ESH-IP 2010 criteria retrospectively on the data reported in these studies was investigated. The performance of the oscillometric devices in the last decade was also investigated on the basis of the ESH-IP criteria. Among 119 published studies, 112 with sufficient data were analyzed. According to ESH-IP 2002, the test device failed in 19 studies, whereas by applying the ESH-IP 2010 criteria in 28 additional studies increased the failure rate from 17 to 42%. Of these 28 studies, in 20 (71%) the test device failed at part 1 (accuracy per measurement) and in 22 (79%) at part 2 (accuracy per subject). Most of the failures involved the '5 mmHg or less' criterion. In the last decade there has been a consistent trend toward improved performance of oscillometric devices assessed on the basis of the ESH-IP criteria. This retrospective analysis shows that the stricter revised ESH-IP 2010 criteria will noticeably increase the failure rate of devices being validated. Oscillometric devices are becoming more accurate, and the revised ESH-IP by acknowledging this trend will allow more accurate devices to enter the market.

  17. Validation of KDRI/KDPI for the selection of expanded criteria kidney donors

    Raimundo M. García del Moral Martín

    2018-05-01

    Full Text Available Introduction: KDRI/KDPI are tools use in kidney donor evaluation. It has been proposed as a substitute of, or complementary to preimplantation renal biopsy. These scores have not been validated in Spain. Objective: (1 To investigate the concordance between KDPI and histological scores (preimplantation renal biopsy and (2 to assess the relationship between KDRI, KDPI and histological score on graft survival in the expanded criteria donors group. Methodology: Retrospective cohort study from 1 January 1998 to 31 December 2010. Results: During the study 120 donors were recruited, that resulted in 220 preimplantation renal biopsies. 144 (65% grafts were considered suitable for kidney transplantation. 76 (34.5% were discarded. Median follow up has been 6.4 years (sd 3.9. Median age 63.1 years (sd 8.2, males (145; 65.9%, non-diabetic (191; 86.8% and without another cardiovascular risk factors (173; 78.6%. 153 (69.5% donors died of cerebrovascular disease. There were significant differences in KDRI/KDPI score in both groups 1.56/89 (sd 0.22 vs 1.66/93 (sd 0.15, p < 0.01. The KDPI showed moderate concordance and correlation with the histological score (AUC 0.64/correlation coefficient 0.24, p < 0.01. KDPI (HR 24.3, p < 0.01 and KDRI (HR 23.3, p < 0.01 scores were associated with graft survival in multivariate analysis. Conclusion: (1 KPDI and histological scores show moderate concordance. The utility of both scores as combined tools it has to be determined. (2 KDPI score, and especially KDRI score, are valid for estimating graft survival and combined with the biopsy can help to individualized decision making in the expanded criteria donors pool. Resumen: Introducción: El KDRI y su variante KDPI son dos herramientas utilizadas para la valoración del donante renal. Se ha propuesto la utilidad del KDPI como sustituto/complementario a la biopsia renal preimplantación. Estos scores no están validados en España. Objetivo: 1 Investigar la

  18. Comprehensive Evaluation Criteria for English Learning Websites Using Expert Validity Surveys

    Yang, Ya-Ting C.; Chan, Chia-Ying

    2008-01-01

    This study aimed to develop a set of evaluation criteria for English learning websites. These criteria can assist English teachers/web designers in designing effective websites for their English courses and can also guide English learners in screening for appropriate and reliable websites to use in increasing their English ability. To fulfill our…

  19. Acceptability criteria for linear dependence in validating UV-spectrophotometric methods of quantitative determination in forensic and toxicological analysis

    L. Yu. Klimenko

    2014-08-01

    Full Text Available Introduction. This article is the result of authors’ research in the field of development of the approaches to validation of quantitative determination methods for purposes of forensic and toxicological analysis and devoted to the problem of acceptability criteria formation for validation parameter «linearity/calibration model». The aim of research. The purpose of this paper is to analyse the present approaches to acceptability estimation of the calibration model chosen for method description according to the requirements of the international guidances, to form the own approaches to acceptability estimation of the linear dependence when carrying out the validation of UV-spectrophotometric methods of quantitative determination for forensic and toxicological analysis. Materials and methods. UV-spectrophotometric method of doxylamine quantitative determination in blood. Results. The approaches to acceptability estimation of calibration models when carrying out the validation of bioanalytical methods is stated in international papers, namely «Guidance for Industry: Bioanalytical method validation» (U.S. FDA, 2001, «Standard Practices for Method Validation in Forensic Toxicology» (SWGTOX, 2012, «Guidance for the Validation of Analytical Methodology and Calibration of Equipment used for Testing of Illicit Drugs in Seized Materials and Biological Specimens» (UNODC, 2009 and «Guideline on validation of bioanalytical methods» (ЕМА, 2011 have been analysed. It has been suggested to be guided by domestic developments in the field of validation of analysis methods for medicines and, particularly, by the approaches to validation methods in the variant of the calibration curve method for forming the acceptability criteria of the obtained linear dependences when carrying out the validation of UV-spectrophotometric methods of quantitative determination for forensic and toxicological analysis. The choice of the method of calibration curve is

  20. Pre-validation of the WHO organ dysfunction based criteria for identification of maternal near miss

    Parpinelli Mary A

    2011-08-01

    Full Text Available Abstract Background To evaluate the performance of the WHO criteria for defining maternal near miss and identifying deaths among cases of severe maternal morbidity (SMM admitted for intensive care. Method Between October 2002 and September 2007, 673 women with SMM were admitted, and among them 18 died. Variables used for the definition of maternal near miss according to WHO criteria and for the SOFA score were retrospectively evaluated. The identification of at least one of the WHO criteria in women who did not die defined the case as a near miss. Organ failure was evaluated through the maximum SOFA score above 2 for each one of the six components of the score, being considered the gold standard for the diagnosis of maternal near miss. The aggregated score (Total Maximum SOFA score was calculated using the worst result of the maximum SOFA score. Sensitivity, specificity, positive and negative predictive values of these WHO criteria for predicting maternal death and also for identifying cases of organ failure were estimated. Results The WHO criteria identified 194 cases of maternal near miss and all the 18 deaths. The most prevalent criteria among cases of maternal deaths were the use of vasoactive drug and the use of mechanical ventilation (≥1 h. For the prediction of maternal deaths, sensitivity was 100% and specificity 70.4%. These criteria identified 119 of the 120 cases of organ failure by the maximum SOFA score (Sensitivity 99.2% among 194 case of maternal near miss (61.34%. There was disagreement in 76 cases, one organ failure without any WHO criteria and 75 cases with no failure but with WHO criteria. The Total Maximum SOFA score had a good performance (area under the curve of 0.897 for prediction of cases of maternal near miss according to the WHO criteria. Conclusions The WHO criteria for maternal near miss showed to be able to identify all cases of death and almost all cases of organ failure. Therefore they allow evaluation of the

  1. Patient perspective workshop: moving towards OMERACT guidelines for choosing or developing instruments to measure patient-reported outcomes.

    Kirwan, John R; Fries, James F; Hewlett, Sarah E; Osborne, Richard H; Newman, Stanton; Ciciriello, Sabina; van de Laar, Mart A; Dures, Emma; Minnock, Patricia; Heiberg, Turid; Sanderson, Tessa C; Flurey, Caroline A; Leong, Amy L; Montie, Pamela; Richards, Pam

    2011-08-01

    The workshop Choosing or Developing Instruments held at the Outcome Measures in Rheumatology (OMERACT) 10 meeting was designed to help participants think about the underlying methods of instrument development. Conference pre-reading material and 3 brief introductory presentations elaborated the issues, and participants broke into discussion groups before reconvening to share insights, engage in a more general discussion of the issues, and vote on recommendations. Tradeoffs between using current imperfect measures and the long and complex process of developing new instruments were considered, together with the need for rigor in patient-reported outcome (PRO) instrument development. The main considerations for PRO instrument development were listed and a research agenda for action produced. As part of the agenda for action, it is recommended that researchers and patient partners work together to tackle these issues, and that OMERACT bring forward proposals for acceptable instrument development protocols that would meet an enhanced "Truth" statement in the OMERACT Filter.

  2. General criteria for validation of dosimetry methods in the context of a quality system ISO / IEC 17025

    Martin Garcia, R.; Navarro Bravo, T.

    2011-01-01

    The accreditation of a testing laboratory in accordance with ISO / IEC 17025 recognizes the technical competence of a laboratory to perform certain tests. One of the requirements of that rule states that laboratories must demonstrate that the methods used are valid and appropriate for the intended use and customer needs. This demonstration is accomplished through the process of validation of methods, defined in the rule it self as c onfirmation by examination and provision of objective evidence that the requirements for a particular purpose . The process of validating a test method should be well planned and documented, including the requirements under the applicable rules and criteria established by the laboratory to comply with these requirements.

  3. Is there any evidence for the validity of diagnostic criteria used for accommodative and nonstrabismic binocular dysfunctions?

    Cacho-Martínez, Pilar; García-Muñoz, Ángel; Ruiz-Cantero, María Teresa

    2014-01-01

    To analyze the diagnostic criteria used in the scientific literature published in the past 25 years for accommodative and nonstrabismic binocular dysfunctions and to explore if the epidemiological analysis of diagnostic validity has been used to propose which clinical criteria should be used for diagnostic purposes. We carried out a systematic review of papers on accommodative and non-strabic binocular disorders published from 1986 to 2012 analysing the MEDLINE, CINAHL, PsycINFO and FRANCIS databases. We admitted original articles about diagnosis of these anomalies in any population. We identified 839 articles and 12 studies were included. The quality of included articles was assessed using the QUADAS-2 tool. The review shows a wide range of clinical signs and cut-off points between authors. Only 3 studies (regarding accommodative anomalies) assessed diagnostic accuracy of clinical signs. Their results suggest using the accommodative amplitude and monocular accommodative facility for diagnosing accommodative insufficiency and a high positive relative accommodation for accommodative excess. The remaining 9 articles did not analyze diagnostic accuracy, assessing a diagnosis with the criteria the authors considered. We also found differences between studies in the way of considering patients' symptomatology. 3 studies of 12 analyzed, performed a validation of a symptom survey used for convergence insufficiency. Scientific literature reveals differences between authors according to diagnostic criteria for accommodative and nonstrabismic binocular dysfunctions. Diagnostic accuracy studies show that there is only certain evidence for accommodative conditions. For binocular anomalies there is only evidence about a validated questionnaire for convergence insufficiency with no data of diagnostic accuracy. Copyright © 2012 Spanish General Council of Optometry. Published by Elsevier Espana. All rights reserved.

  4. Validation of revised Epstein's criteria for insignificant prostate cancer prediction in a Greek subpopulation.

    Chondros, Κ; Karpathakis, Ν; Heretis, Ι; Mavromanolakis, Ε; Chondros, N; Sofras, F; Mamoulakis, C

    2015-01-01

    Different treatment options for patients with prostate cancer (PCa) are applicable after stratifying patients according to various classification criteria. The purpose of our study is to evaluate the revised Epstein's criteria for insignificant PCa prediction in a Greek subpopulation. During a 4-year-period, 172 Cretan patients were submitted to radical retropubic prostatectomy in our institution. 23 out of them met the revised Epstein's criteria for the presence of clinically insignificant PCa (clinical stage T1c, prostate specific antigen density < 0.15 ng/ml/g, absence of Gleason pattern 4-5, <3 positive biopsy cores, presence of <50% tumor per core) during pre-treatment evaluation and were retrospectively included in the study. Post-surgery outcomes were evaluated including pathological stage, surgical margins and Gleason score upgrade. Organ confined disease and insignificant PCa were predicted with a 74% and 31% accuracy, respectively. These figures are remarkably lower than those derived from similar studies worldwide. Due to the high variation in the revised Epstein's criteria prediction accuracy observed worldwide, the development and implementation of novel tools/nomograms with a greater predictive accuracy is still warranted. Hippokratia 2015, 19 (1): 30-33.

  5. Validation of an automatic diagnosis of strict left bundle branch block criteria using 12-lead electrocardiograms

    Xia, Xiaojuan; Ruwald, Anne-Christine; Ruwald, Martin H

    2017-01-01

    AIMS: Strict left bundle branch block (LBBB) criteria were recently proposed to identify LBBB patients to benefit most from cardiac resynchronization therapy (CRT). The aim of our study was to automate identification of strict LBBB in order to facilitate its broader application. METHODS: We devel...

  6. Validity of Criteria-Based Content Analysis (CBCA) at Trial in Free-Narrative Interviews

    Roma, Paolo; San Martini, Pietro; Sabatello, Ugo; Tatarelli, Roberto; Ferracuti, Stefano

    2011-01-01

    Objective: The reliability of child witness testimony in sexual abuse cases is often controversial, and few tools are available. Criteria-Based Content Analysis (CBCA) is a widely used instrument for evaluating psychological credibility in cases of suspected child sexual abuse. Only few studies have evaluated CBCA scores in children suspected of…

  7. Validation of a new multiaxial criteria for creep-fatigue damage evaluation

    Cabrillat, M.T.; Martin, P.

    1989-01-01

    For many years, design codes evaluated creep damage using the Von Mises criterion to take account of multiaxiality of stresses. However, recent studies have confirmed that the Von Mises criterion is overconservative for nonuniaxial stress state. Various criteria have been put forward to take account of the real stress state. This paper describes a criterion which was introduced in 1987 and the various studies which led to its adoption

  8. The Spanish version of the 2010 American College of Rheumatology Preliminary Diagnostic Criteria for fibromyalgia: reliability and validity assessment.

    Casanueva, Benigno; García-Fructuoso, Ferrán; Belenguer, Rafael; Alegre, Cayetano; Moreno-Muelas, José V; Hernández, José L; Pina, Tinitario; González-Gay, Miguel Á

    2016-01-01

    To investigate the reliability and validity of the Spanish version of the 2010 American College of Rheumatology (ACR) Preliminary Diagnostic Criteria for Fibromyalgia (FM) in patients with chronic pain. The 2010 ACR Preliminary Diagnostic Criteria for FM were adapted to a Spanish version following the guidelines of the Rheumatology Spanish Society Study Group of FM. Based on the 1990 ACR classi cation criteria for FM, patients with chronic pain were initially divided into two groups: a FM group and another group of non-FM individuals. Patients from the FM group were evaluated by tender points (TP) examination, Fibromyalgia Impact Questionnaire (FIQ), Widespread Pain Index (WPI), and Symptom Severity Scale (SSS). The non-FM (control) group included patients with rheumatoid arthritis (RA) and osteoarthritis (OA). They were evaluated by WPI and SSS. We included 1,169 patients divided into two groups: FM group (n=803; 777 women and 26 men) and non-FM group (n= 366; 147 patients with RA, and 219 with OA). The median value of TP and FIQ in the FM group was 16 and 74 respectively. The preliminary 2010 ACR criteria were met by 665 (82.8%) FM patients and by 112 (30.6%) patients from the non-FM group (pFIQ (p<0.0001), WPI (p<0.0001) and SSS (p<0.0001) were observed when FM patients fulfilling the 2010 ACR criteria were compared with the remaining FM patients who did not fulfill these criteria. Sensitivity of the Spanish version of the 2010 ACR criteria was 85.6% (95%CI: 83.1-88.1), speci city 73.2% (95%CI: 68.4-78), positive predictive value 87.7% (95%CI: 85.3-90.1) and negative predictive value 69.4% (95%CI: 64.5-74.2). Our results indicate that the 2010 ACR Preliminary Diagnostic Criteria for FM may be useful to establish a diagnosis of FM in Spanish individuals with chronic pain.

  9. Testing the Construct Validity of Proposed Criteria for "DSM-5" Autism Spectrum Disorder

    Mandy, William P. L.; Charman, Tony; Skuse, David H.

    2012-01-01

    Objective: To use confirmatory factor analysis to test the construct validity of the proposed "DSM-5" symptom model of autism spectrum disorder (ASD), in comparison to alternative models, including that described in "DSM-IV-TR." Method: Participants were 708 verbal children and young persons (mean age, 9.5 years) with mild to severe autistic…

  10. The OMERACT Ultrasound Group: status of current activities and research directions

    Wakefield, Richard J; D'Agostino, Maria-Antonietta; Iagnocco, Annamaria

    2007-01-01

    Ultrasound (US) is a relatively new imaging modality in rheumatology that offers great potential as a diagnostic and management tool. In 2004, an OMERACT Ultrasound Special Interest Group was formed to address the metric qualities of US as a potential outcome measure. A preliminary systematic...... review highlighted the deficiencies in the literature, particularly with regard to the reliability of interpreting and acquiring images; as a consequence, a number of exercises were proposed to address these issues. This report describes a series of iterative studies that have resulted in improved intra...

  11. Development and Reliability of the OMERACT Thumb Base Osteoarthritis Magnetic Resonance Imaging Scoring System

    Kroon, Féline P B; Conaghan, Philip G; Foltz, Violaine

    2017-01-01

    : The TOMS assessed the first carpometacarpal (CMC-1) and scaphotrapeziotrapezoid (STT) joints for synovitis, subchondral bone defects (including erosions, cysts, and bone attrition), osteophytes, cartilage, and bone marrow lesions on a 0-3 scale (normal to severe). Subluxation was evaluated only in the CMC......, with better performance for subchondral bone defects, subluxation, and bone marrow lesions. CONCLUSION: A thumb base OA MRI scoring system has been developed. The OMERACT TOMS demonstrated good intrareader and interreader reliability. Longitudinal studies are warranted to investigate reliability of change...

  12. Predicting DMS-IV cluster B personality disorder criteria from MMPI-2 and Rorschach data: a test of incremental validity.

    Blais, M A; Hilsenroth, M J; Castlebury, F; Fowler, J C; Baity, M R

    2001-02-01

    Despite their frequent conjoint clinical use, the incremental validity of Rorschach (Rorschach, 1921/1942) and MMPI (Hathaway & McKinley, 1943) data has not been adequately established, nor has any study to date explored the incremental validity of these tests for predicting Diagnostic and Statistical Manual of Mental Disorders (4th ed. [DSM-IV]; American Psychiatric Association, 1994) personality disorders (PDs). In a reanalysis of existing data, we used select Rorschach variables and the MMPI PD scales to predict DSM-IV antisocial, borderline, histrionic, and narcissistic PD criteria in a sample of treatment-seeking outpatients. The correlational findings revealed alimited relation between Rorschach and MMPI-2 (Butcher, Dahlstrom, Graham, Tellegen, & Kaemmer, 1989) variables, with only 5 of 30 correlations reaching significance (p psychological characteristics of the DSM-IV Cluster B PDs.

  13. On various validity criteria for the configuration average in collisional-radiative codes

    Poirier, M [Commissariat a l' Energie Atomique, Service ' Photons, Atomes et Molecules' , Centre d' Etudes de Saclay, F91191 Gif-sur-Yvette Cedex (France)

    2008-01-28

    The characterization of out-of-local-thermal-equilibrium plasmas requires the use of collisional-radiative kinetic equations. This leads to the solution of large linear systems, for which statistical treatments such as configuration average may bring considerable simplification. In order to check the validity of this procedure, a criterion based on the comparison between a partial-rate systems and the Saha-Boltzmann solution is discussed in detail here. Several forms of this criterion are discussed. The interest of these variants is that they involve each type of relevant transition (collisional or radiative), which allows one to check separately the influence of each of these processes on the configuration-average validity. The method is illustrated by a charge-distribution analysis in carbon and neon plasmas. Finally, it is demonstrated that when the energy dispersion of every populated configuration is smaller than the electron thermal energy, the proposed criterion is fulfilled in each of its forms.

  14. OMERACT Rheumatoid Arthritis Magnetic Resonance Imaging Studies. Exercise 5: an international multicenter reliability study using computerized MRI erosion volume measurements

    Bird, P; Ejbjerg, B; McQueen, F

    2003-01-01

    with metacarpophalangeal (MCP) joints 2 to 5 of the dominant hand included in the field of view. Three readers were instructed to grade MCP 2 and 3 using the OMERACT grading system and then to measure the erosion volume of the same joints using OSIRIS software. The inter-reader reliability of the grading method...

  15. OMERACT/OARSI initiative to define states of severity and indication for joint replacement in hip and knee osteoarthritis

    Gossec, Laure; Hawker, Gillian; Davis, Aileen M

    2007-01-01

    OBJECTIVE: Time to theoretical indication of joint replacement surgery has been proposed as a primary outcome for potential structure-modifying interventions for osteoarthritis (OA). The objectives of this OMERACT/OARSI Working Group were to identify pain, physical function, and structure states ...

  16. Reliability and sensitivity to change of the OMERACT rheumatoid arthritis magnetic resonance imaging score in a multireader, longitudinal setting

    Haavardsholm, ea; Østergaard, Mikkel; Kvan, NP

    2005-01-01

    OBJECTIVE: To assess the intra- and interreader reliability and the sensitivity to change of the Outcome Measures in Rheumatology Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Imaging Score (RAMRIS) system on digital images of the wrist joints of patients with early or establi...

  17. Assessment of somatotype in young voleyball players: Validity as criteria to select young sports talents

    Moisés de Hoyo Lora

    2008-07-01

    Full Text Available http://dx.doi.org/10.5007/1980-0037.2008v10n3p255 The anthropometric characteristics of athletes can determine their sporting performance. For this reason, we’ve defined the somatotype of young volleyball players in order to be able to control their sports training and to ensure their appropriate athletic development. In the present investigation 154 male and female volleyball players (aged from 12 to 14 years were analyzed. Data were collected according to the ISAK protocol. The results show an endomesomorphic profile for male and female volleyball players agreeing with the predominant profile at these ages. However, after comparing these data with results obtained in other studies, we observed a certain homogeneity in the male somatotype, invalidating the current trend of using this parameter as criteria to select young sports talent. However, somatotype could be a factor to take into account with female athletes, since their profile is much more heterogeneous.

  18. OARSI-OMERACT definition of relevant radiological progression in hip/knee osteoarthritis.

    Ornetti, P; Brandt, K; Hellio-Le Graverand, M-P; Hochberg, M; Hunter, D J; Kloppenburg, M; Lane, N; Maillefert, J-F; Mazzuca, S A; Spector, T; Utard-Wlerick, G; Vignon, E; Dougados, M

    2009-07-01

    Joint space width (JSW) evaluated in millimeters on plain X-rays is the currently optimal recognized technique to evaluate osteoarthritis (OA) structural progression. Data obtained can be presented at the group level (e.g., mean+/-standard deviation of the changes). Such presentation makes difficult the interpretation of the clinical relevance of the reported results. Therefore, a presentation at the individual level (e.g., % progressors) seems more attractive but requires to determining a cut-off. Several methodologies have been proposed to define cut-offs in JSW: arbitrary chosen cut-off, cut-off based on the validity to predict a relevant end-point such as the requirement of total articular replacement or cut-off based on the measurement error such as smallest detectable difference (SDD). The objective of this OARSI-OMERACT initiative was to define a cut-off evaluated in millimeters on plain X-rays above which a change in JSW could be considered as relevant in patients with hip and knee OA. The first step consisted in a systematic literature research performed using Medline database up to July 2007 to obtain all manuscripts published between 1990 and 2007 reporting a cut-off value in JSW evaluated in millimeters at either the knee or hip level. The second step consisted in a consensus based on the best knowledge of the 11 experts with the support of the available evidence. Among the 506 articles selected by the search, 47 articles reported cut-off of JSW in millimeters. There was a broad heterogeneity in cut-off values, whatever the methodologies or the OA localization considered (e.g., from 0.12 to 0.84 mm and from 0.22 to 0.78 mm for Knee (seven studies) and hip (seven studies), respectively when considering the data obtained based on the reliability). Based on the data extracted in the literature, the expert committee proposed a definition of relevant change in JSW based on plain X-rays, on an absolute change of JSW in millimeters and on the measurement error

  19. Neurophysiological localisation of ulnar neuropathy at the elbow: validation of diagnostic criteria developed by a taskforce of the Danish Society of Clinical Neurophysiology

    Pugdahl, Kirsten; Beniczky, Sándor; Wanscher, Benedikte

    2017-01-01

    OBJECTIVE: This study validates consensus criteria for localisation of ulnar neuropathy at elbow (UNE) developed by a taskforce of the Danish Society of Clinical Neurophysiology and compares them to the existing criteria from the American Association of Neuromuscular and Electrodiagnostic Medicine...

  20. Toward Ensuring Health Equity: Readability and Cultural Equivalence of OMERACT Patient-reported Outcome Measures.

    Petkovic, Jennifer; Epstein, Jonathan; Buchbinder, Rachelle; Welch, Vivian; Rader, Tamara; Lyddiatt, Anne; Clerehan, Rosemary; Christensen, Robin; Boonen, Annelies; Goel, Niti; Maxwell, Lara J; Toupin-April, Karine; De Wit, Maarten; Barton, Jennifer; Flurey, Caroline; Jull, Janet; Barnabe, Cheryl; Sreih, Antoine G; Campbell, Willemina; Pohl, Christoph; Duruöz, Mehmet Tuncay; Singh, Jasvinder A; Tugwell, Peter S; Guillemin, Francis

    2015-12-01

    The goal of the Outcome Measures in Rheumatology (OMERACT) 12 (2014) equity working group was to determine whether and how comprehensibility of patient-reported outcome measures (PROM) should be assessed, to ensure suitability for people with low literacy and differing cultures. The English, Dutch, French, and Turkish Health Assessment Questionnaires and English and French Osteoarthritis Knee and Hip Quality of Life questionnaires were evaluated by applying 3 readability formulas: Flesch Reading Ease, Flesch-Kincaid grade level, and Simple Measure of Gobbledygook; and a new tool, the Evaluative Linguistic Framework for Questionnaires, developed to assess text quality of questionnaires. We also considered a study assessing cross-cultural adaptation with/without back-translation and/or expert committee. The results of this preconference work were presented to the equity working group participants to gain their perspectives on the importance of comprehensibility and cross-cultural adaptation for PROM. Thirty-one OMERACT delegates attended the equity session. Twenty-six participants agreed that PROM should be assessed for comprehensibility and for use of suitable methods (4 abstained, 1 no). Twenty-two participants agreed that cultural equivalency of PROM should be assessed and suitable methods used (7 abstained, 2 no). Special interest group participants identified challenges with cross-cultural adaptation including resources required, and suggested patient involvement for improving translation and adaptation. Future work will include consensus exercises on what methods are required to ensure PROM are appropriate for people with low literacy and different cultures.

  1. The OMERACT psoriatic arthritis magnetic resonance imaging scoring system (PsAMRIS): definitions of key pathologies, suggested MRI sequences, and preliminary scoring system for PsA Hands

    Østergaard, Mikkel; McQueen, Fiona; Wiell, Charlotte

    2009-01-01

    This article describes a preliminary OMERACT psoriatic arthritis magnetic resonance image scoring system (PsAMRIS) for evaluation of inflammatory and destructive changes in PsA hands, which was developed by the international OMERACT MRI in inflammatory arthritis group. MRI definitions of important...... pathologies in peripheral PsA and suggestions concerning appropriate MRI sequences for use in PsA hands are also provided....

  2. PATHOGENETIC VALIDATION OF ADDITIONAL OBJECTIVE CRITERIA FOR POSSIBLE EFFECTIVE PREGNANCY PROLONGATION AFTER PREMATURE MEMBRANE RUPTURE

    L. I. Dyatlova

    2015-01-01

    , when adequate and comprehensive therapy was applied. In the course of pregnancy prolongation, we found a progressive increase in pro-inflammatory cytokine levels (IL-2, IL-6, IL-8, TNFα, a steady decrease in CD19+ B cell counts, CD3+СD4+ helpers, natural killer cells, increased levels of cytotoxic CD3+CD8+ T cells .The pathogenesis-based criteria for necessary termination of the pregnancy for women with PROM are identified, including an increase in acute-phase proteins levels in blood, development of neutrophilic leukocytosis, lymphopenia, increase of pro-inflammatory cytokine levels in blood (IL-1β, IL-6, IL-8, TNFα, along with progressive reduction of CD3+СD4+ lymphocytes, CD16+CD56+ and CD19+ В lymphocytes.  

  3. Assessment of somatotype in young voleyball players: Validity as criteria to select young sports talents

    Luís Carrasco Páez

    2008-06-01

    Full Text Available The anthropometric characteristics of athletes can determine their sporting performance. For this reason, we’ve defined the somatotype of young volleyball players in order to be able to control their sports training and to ensure their appropriate athletic development. In the present investigation 154 male and female volleyball players (aged from 12 to 14 years were analyzed. Data were collected according to the ISAK protocol. The results show an endomesomorphic profile for male and female volleyball players agreeing with the predominant profile at these ages. However, after comparing these data with results obtained in other studies, we observed a certain homogeneity in the male somatotype, invalidating the current trend of using this parameter as criteria to select young sports talent. However, somatotype could be a factor to take into account with female athletes, since their profile is much more heterogeneous. ResumoLas características antropométricas de los deportistas pueden determinar su rendimiento deportivo. Por esa razón se pretende conocer el somatotipo de jugadores infantiles de voleibol para poder así, controlar el entrenamiento y asegurar un adecuado desarrollo de los deportistas. En este estudio se analizaron 154 jugadores/as, con edades comprendidas entre 12 y 14 años. Los datos se extrajeron según las técnicas recomendadas por la ISAK (2001. Los resultados mostraron um perfil endomesomorfo tanto en chicos como en chicas, lo que concuerda con el perfil predominante en estas edades. Por otra parte, al comparar el somatotipo de estos jugadores con el de otros estudios observamos una cierta homogeneidad en el caso de los chicos, lo que invalidaría la tendencia actual de usar este parámetro como criterio para la selección de jóvenes talentos deportivos. Sin embargo, si podría ser un elemento a tener en cuenta en el caso de las chicas, ya que su perfil es mucho más heterogéneo.

  4. Development of a Draft Core Set of Domains for Measuring Shared Decision Making in Osteoarthritis: An OMERACT Working Group on Shared Decision Making.

    Toupin-April, Karine; Barton, Jennifer; Fraenkel, Liana; Li, Linda; Grandpierre, Viviane; Guillemin, Francis; Rader, Tamara; Stacey, Dawn; Légaré, France; Jull, Janet; Petkovic, Jennifer; Scholte-Voshaar, Marieke; Welch, Vivian; Lyddiatt, Anne; Hofstetter, Cathie; De Wit, Maarten; March, Lyn; Meade, Tanya; Christensen, Robin; Gaujoux-Viala, Cécile; Suarez-Almazor, Maria E; Boonen, Annelies; Pohl, Christoph; Martin, Richard; Tugwell, Peter S

    2015-12-01

    Despite the importance of shared decision making for delivering patient-centered care in rheumatology, there is no consensus on how to measure its process and outcomes. The aim of this Outcome Measures in Rheumatology (OMERACT) working group is to determine the core set of domains for measuring shared decision making in intervention studies in adults with osteoarthritis (OA), from the perspectives of patients, health professionals, and researchers. We followed the OMERACT Filter 2.0 method to develop a draft core domain set by (1) forming an OMERACT working group; (2) conducting a review of domains of shared decision making; and (3) obtaining opinions of all those involved using a modified nominal group process held at a session activity at the OMERACT 12 meeting. In all, 26 people from Europe, North America, and Australia, including 5 patient research partners, participated in the session activity. Participants identified the following domains for measuring shared decision making to be included as part of the draft core set: (1) identifying the decision, (2) exchanging information, (3) clarifying views, (4) deliberating, (5) making the decision, (6) putting the decision into practice, and (7) assessing the effect of the decision. Contextual factors were also suggested. We proposed a draft core set of shared decision-making domains for OA intervention research studies. Next steps include a workshop at OMERACT 13 to reach consensus on these proposed domains in the wider OMERACT group, as well as to detail subdomains and assess instruments to develop a core outcome measurement set.

  5. Development of a Draft Core Set of Domains for Measuring Shared Decision Making in Osteoarthritis: An OMERACT Working Group on Shared Decision Making

    Toupin April, Karine; Barton, Jennifer; Fraenkel, Liana; Li, Linda; Grandpierre, Viviane; Guillemin, Francis; Rader, Tamara; Stacey, Dawn; Légaré, France; Jull, Janet; Petkovic, Jennifer; Scholte Voshaar, Marieke; Welch, Vivian; Lyddiatt, Anne; Hofstetter, Cathie; De Wit, Maarten; March, Lyn; Meade, Tanya; Christensen, Robin; Gaujoux-Viala, Cécile; Suarez-Almazor, Maria E.; Boonen, Annelies; Pohl, Christoph; Martin, Richard; Tugwell, Peter

    2015-01-01

    Objective Despite the importance of shared decision making for delivering patient-centred care in rheumatology, there is no consensus on how to measure its process and outcomes. The aim of this OMERACT working group is to determine the core set of domains for measuring shared decision making in intervention studies in adults with osteoarthritis (OA), from the perspective of patients, health professionals and researchers. Methods We followed the OMERACT Filter 2.0 to develop a draft core domain set, which consisted of: (i) forming an OMERACT working group; (ii) conducting a review of domains of shared decision making; and (iii) obtaining the opinions of stakeholders using a modified nominal group process held at a session activity at the OMERACT 2014 meeting. Results 26 stakeholders from Europe, North America and Australia, including 5 patient research partners, participated in the session activity. Participants identified the following domains for measuring shared decision making to be included as part of the Draft Core Set: 1) Identifying the decision; 2) Exchanging Information; 3) Clarifying views; 4) Deliberating; 5) Making the decision; 6) Putting the decision into practice; and 7) Assessing the impact of the decision. Contextual factors were also suggested. Conclusion We propose a Draft Core Set of shared decision making domains for OA intervention research studies. Next steps include a workshop at OMERACT 2016 to reach consensus on these proposed domains in the wider OMERACT group, as well as detail sub-domains and assess instruments to develop a Core Outcome Measurement Set. PMID:25877502

  6. Validation of the ICSD-2 criteria for CSF hypocretin-1 measurements in the diagnosis of narcolepsy in the Danish population

    Knudsen, Stine; Jennum, Poul J; Alving, Jørgen

    2010-01-01

    STUDY OBJECTIVES: The International Classification of Sleep Disorders (ICSD-2) criteria for low CSF hypocretin-1 levels (CSF hcrt-1) still need validation as a diagnostic tool for narcolepsy in different populations because inter-assay variability and different definitions of hypocretin deficiency...... complicate direct comparisons of study results. DESIGN AND PARTICIPANTS: Interviews, polysomnography, multiple sleep latency test, HLA-typing, and CSF hcrt-1 measurements in Danish patients with narcolepsy with cataplexy (NC) and narcolepsy without cataplexy (NwC), CSF hcrt-1 measurements in other......). MEASUREMENTS AND RESULTS: In Danes, low CSF hcrt-1 was present in 40/46 NC, 3/14 NwC and 0/106 controls (P sleep latency, more sleep...

  7. Evaluation of the Validity of three Criteria for Sampling and Analyzing DST Wastes in Support of Waste Feed Delivery

    BOGER, R.M.

    2000-01-01

    This document summarizes the analysis of 3 basic criteria for the sampling systems that will provide waste validation samples of tank waste feeds prior to delivery to the waste treatment and immobilization plant where the wastes will be converted to glass forms. The assessed criteria includes sampling through a 4-inch riser, sampling while a mixer pump is operating, and the deployment of an at-tank analysis system. The assessment, based on the Phase I, 3S6 waste feed scenario, indicated that for high level waste, sampling through a 4-inch riser is not required but sampling while mixer pumps are operating will be required. For low activity waste, sampling through a 4-inch riser will be required but sampling while mixer pumps are operating is not required. The assessment indicated that an at-tank analysis system to provide tank mixing/settling (homogeneity) status is not needed since the number of tanks providing LAW feed was expanded and the payment basis in the original privatization contract has been modified

  8. The Japanese version of the modified ACR preliminary diagnostic criteria for fibromyalgia and the fibromyalgia symptom scale: reliability and validity.

    Usui, Chie; Hatta, Kotaro; Aratani, Satoko; Yagishita, Naoko; Nishioka, Kenya; Kanazawa, Teruhisa; Itoh, Kenji; Yamano, Yoshihisa; Nakamura, Hiroyuki; Nakajima, Toshihiro; Nishioka, Kusuki

    2013-09-01

    The aim of this study is to investigate the reliability and validity of the Japanese version of the modified American College of Rheumatology (ACR) Preliminary Diagnostic Criteria for Fibromyalgia (mACR 2010-J) and the Fibromyalgia Symptom Scale (mFS-J). According to the ACR 1990 classification criteria, patients with chronic pain were divided into the fibromyalgia group and nonfibromyalgia group (rheumatoid arthritis and osteoarthritis). Patients in both groups were assessed using mACR 2010-J and mFS-J. 294 of 462 (64 %) patients in the fibromyalgia group met mACR 2010-J, whereas 4 % (9/231) of the nonfibromyalgia group did, with sensitivity of 64 %, specificity of 96 %, positive predictive value of 97 %, negative predictive value of 56 %, and positive likelihood ratio of 16.3. Mean total scores on mFS-J significantly differentiated the fibromyalgia from the nonfibromyalgia group. According to the value of the Youden index, the best cutoff score for the mFS-J was 9/10. Our findings indicate that mACR 2010-J as a positive test and mFS-J as a quantification scale might be suitable for assessing fibromyalgia among Japanese chronic pain populations.

  9. Predictive validity of the ASAS classification criteria for axial and peripheral spondyloarthritis after follow-up in the ASAS cohort

    Sepriano, Alexandre; Landewé, Robert; van der Heijde, Désirée

    2016-01-01

    OBJECTIVE: To establish the predictive validity of the Assessment of SpondyloArthritis international Society (ASAS) spondyloarthritis (SpA) classification criteria. METHODS: 22 centres (N=909 patients) from the initial 29 ASAS centres (N=975) participated in the ASAS-cohort follow-up study...... classification by the ASAS criteria was calculated using rheumatologist's diagnosis at follow-up as external standard. RESULTS: In total, 564 patients were assessed at follow-up (345 visits; 219 telephone) with a mean follow-up of 4.4 years (range: 1.9; 6.8) and 70.2% received a SpA diagnosis....... Patients had either chronic (>3 months) back pain of unknown origin and age of onset below 45 years (N=658) or peripheral arthritis and/or enthesitis and/or dactylitis (N=251). At follow-up, information was obtained at a clinic visit or by telephone. The positive predictive value (PPV) of the baseline...

  10. Cadmium risks to freshwater life: derivation and validation of low-effect criteria values using laboratory and field studies

    Mebane, Christopher A.

    2006-01-01

    ' criterion) was calculated as 0.75 mug/L cadmium using the hardness-dependent equation CMC = e(0.8403 ? ln(hardness)-3.572) where the 'ln hardness' is the natural logarithm of the water hardness. Likewise, the criterion continuous concentration (CCC, or 'chronic' criterion) was calculated as 0.37 mug/L cadmium using the hardness-dependent equation CCC = (e(0.6247 ? ln(hardness)-3.384)) ? (1.101672 - ((ln hardness) ? 0.041838))). Using data that were independent of those used to derive the criteria, the criteria concentrations were evaluated to estimate whether adverse effects were expected to the biological integrity of natural waters or to selected species listed as threatened or endangered. One species was identified that would not be fully protected by the derived CCC, the amphipod Hyalella azteca. Exposure to CCC conditions likely would lead to population decreases in Hyalella azteca, the food web consequences of which probably would be slight if macroinvertebrate communities were otherwise diverse. Some data also suggested adverse behavioral changes are possible in fish following long-term exposures to low levels of cadmium, particularly in char (genus Salvelinus). Although ambiguous, these data indicate a need to periodically review the literature on behavioral changes in fish following metals exposure as more information becomes available. Most data reviewed indicated that criteria conditions were unlikely to contribute to overt adverse effects to either biological integrity or listed species. If elevated cadmium concentrations that approach the chronic criterion values occur in ambient waters, careful biological monitoring of invertebrate and fish assemblages would be prudent to validate the prediction that the assemblages would not be adversely affected by cadmium at criterion concentrations.

  11. Validation of the criteria for initiating the cleaning of heating, ventilation, and air-conditioning (HVAC) ductwork under real conditions.

    Lavoie, Jacques; Marchand, Geneviève; Cloutier, Yves; Lavoué, Jérôme

    2011-08-01

    Dust accumulation in the components of heating, ventilation, and air-conditioning (HVAC) systems is a potential source of contaminants. To date, very little information is available on recognized methods for assessing dust buildup in these systems. The few existing methods are either objective in nature, involving numerical values, or subjective in nature, based on experts' judgments. An earlier project aimed at assessing different methods of sampling dust in ducts was carried out in the laboratories of the Institut de recherche Robert-Sauvé en santé et en sécurité du travail (IRSST). This laboratory study showed that all the sampling methods were practicable, provided that a specific surface-dust cleaning initiation criterion was used for each method. However, these conclusions were reached on the basis of ideal conditions in a laboratory using a reference dust. The objective of this present study was to validate these laboratory results in the field. To this end, the laboratory sampling templates were replicated in real ducts and the three sampling methods (the IRSST method, the method of the U.S. organization National Air Duct Cleaner Association [NADCA] and that of the French organization Association pour la Prévention et l'Étude de la Contamination [ASPEC]) were used simultaneously in a statistically representative number of systems. The air return and supply ducts were also compared. Cleaning initiation criteria under real conditions were found to be 6.0 mg/100 cm(2) using the IRSST method, 2.0 mg/100 cm(2) using the NADCA method, and 23 mg/100 cm(2) using the ASPEC method. In the laboratory study, the criteria using the same methods were 6.0 for the IRSST method, 2.0 for the NADCA method, and 3.0 for the ASPEC method. The laboratory criteria for the IRSST and NADCA methods were therefore validated in the field. The ASPEC criterion was the only one to change. The ASPEC method therefore allows for the most accurate evaluation of dust accumulation in HVAC

  12. Fertility preservation for girls and young women with cancer: population-based validation of criteria for ovarian tissue cryopreservation.

    Wallace, W Hamish B; Smith, Alice Grove; Kelsey, Thomas W; Edgar, Angela E; Anderson, Richard A

    2014-09-01

    assessable patients who had declined the procedure, one had developed premature ovarian insufficiency. Assessment of ovarian function was possible for 141 of the 376 patients who were not offered cryopreservation; one of these patients had developed premature ovarian insufficiency. The cumulative probability of developing premature ovarian insufficiency after treatment was completed was significantly higher for patients who met the criteria for ovarian tissue cryopreservation than for those who did not (15-year probability 35% [95% CI 10-53] vs 1% [0-2]; pgirls and young women who will develop premature ovarian insufficiency, and validate their use for selection of patients for ovarian tissue cryopreservation. Further follow-up of this cohort of patients is likely to allow refinement of the criteria for this experimental procedure in girls and young women with cancer. UK Medical Research Council. Copyright © 2014 Wallace et al. Open Access article distributed under the terms of CC BY-NC-ND. Published by Elsevier Ltd. All rights reserved.

  13. Progress on incorporating the patient perspective in outcome assessment in rheumatology and the emergence of life impact measures at OMERACT 9.

    Kirwan, John R

    2009-09-01

    The Patient Perspective Workshop included over 100 researchers and 18 patient participants from 8 countries. Following preconference reading and short plenary presentations, breakout groups considered work undertaken on measurement of sleep, assessing interventions to develop the effective consumer, and assessing psychological and educational interventions. The workshop explored the best way to identify other outcome domains (and instruments) that should be measured in observational or interventional studies with broader intentions than simply altering outcomes captured in the traditional "core set" plus fatigue. Four sleep questionnaires showed promise and will be the subject of further study. The Effective Consumer scale (EC-17) was reviewed and the concept Effective Consumer was well received. Participants thought it worthwhile to measure the skills and attributes of an effective consumer and develop an intervention that would include education in all of the scale\\'s categories. Assessment of educational and psychological interventions requires a wider set of instruments than is currently used; these should relate to the purpose of the intervention. This principle was extended to include wider measures of the impact of disease on life, as indicated in the International Classification of Functioning, Disability and Health. Life impact measure sets covering domains appropriate to different rheumatic conditions and focused on different interventions might be defined by future OMERACT consensus. Measurement instruments within these domains that are valid for use in rheumatic conditions can then be identified and, in the case of psychological and educational interventions, chosen to fit with the purpose of the intervention.

  14. Progress Towards a Core Set of Outcome Measures in Small-vessel Vasculitis. Report from OMERACT 9

    MERKEL, PETER A.; HERLYN, KAREN; MAHR, ALFRED D.; NEOGI, TUHINA; SEO, PHILIP; WALSH, MICHAEL; BOERS, MAARTEN; LUQMANI, RAASHID

    2011-01-01

    The past decade has seen a substantial increase in the number and quality of clinical trials of new therapies for vasculitis, including randomized, controlled, multicenter trials that have successfully incorporated measures of disease activity and toxicity. However, because current treatment regimens for severe disease effectively induce initial remission and reduce mortality, future trials will focus on any of several goals including: (a) treatment of mild—moderate disease; (b) prevention of chronic damage; (c) reduction in treatment toxicity; or (d) more subtle differences in remission induction or maintenance. Thus, new trials will require outcome measure instruments that are more precise and are better able to detect effective treatments for different disease states and measure chronic manifestations of disease. The OMERACT Vasculitis Working Group comprises international clinical investigators with expertise in vasculitis who, since 2002, have worked collaboratively to advance the refinement of outcome measures in vasculitis, create new measures to address domains of illness not covered by current research approaches, and harmonize outcome assessment in vasculitis. The focus of the OMERACT group to date has been on outcome measures in small-vessel vasculitis with an overall goal of creating a core set of outcome measures for vasculitis, each of which fulfills the OMERACT filter of truth, discrimination, feasibility, and identifying additional domains requiring further research. This process has been informed by several ongoing projects providing data on outcomes of disease activity, disease-related damage, multidimensional health-related quality of life, and patient-reported ratings of the burden of vasculitis. PMID:19820226

  15. Validation of a Knowledge Transfer Tool According to the OMERACT Filter

    Jaremko, Jacob L; Azmat, Omar; Lambert, Robert G. W.

    2017-01-01

    , whether by conventional spreadsheet-based scoring or by a Web-based interface with interactive feedback. The new method allowed faster readings, provided a consistent training environment that helped inexperienced readers achieve reliability equivalent to that of conventional methods, and was preferred...... with the spreadsheet method and then used the Web-based method than in those who began with the Web-based method, especially at the acetabulum. Readers found Web-based/RETIC scoring more user-friendly and nearly 50% faster than traditional spreadsheet methods. CONCLUSION: HIMRISS offers reliable BML scoring in OA...

  16. Neurophysiological localisation of ulnar neuropathy at the elbow: Validation of diagnostic criteria developed by a taskforce of the Danish Society of clinical neurophysiology.

    Pugdahl, K; Beniczky, S; Wanscher, B; Johnsen, B; Qerama, E; Ballegaard, M; Benedek, K; Juhl, A; Ööpik, M; Selmar, P; Sønderborg, J; Terney, D; Fuglsang-Frederiksen, A

    2017-11-01

    This study validates consensus criteria for localisation of ulnar neuropathy at elbow (UNE) developed by a taskforce of the Danish Society of Clinical Neurophysiology and compares them to the existing criteria from the American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM). The Danish criteria are based on combinations of conduction slowing in the segments of the elbow and forearm expressed in Z-scores, and difference between the segments in m/s. Examining fibres to several muscles and sensory fibres can increase the certainty of the localisation. Diagnostic accuracy for UNE was evaluated on 181 neurophysiological studies of the ulnar nerve from 171 peer-reviewed patients from a mixed patient-group. The diagnostic reference standard was the consensus diagnosis based on all available clinical, laboratory, and electrodiagnostic information reached by a group of experienced Danish neurophysiologists. The Danish criteria had high specificity (98.4%) and positive predictive value (PPV) (95.2%) and fair sensitivity (76.9%). Compared to the AANEM criteria, the Danish criteria had higher specificity (p<0.001) and lower sensitivity (p=0.02). The Danish consensus criteria for UNE are very specific and have high PPV. The Danish criteria for UNE are reliable and well suited for use in different centres as they are based on Z-scores. Copyright © 2017 International Federation of Clinical Neurophysiology. Published by Elsevier B.V. All rights reserved.

  17. Content and Construct Validity, Reliability, and Responsiveness of the Rheumatoid Arthritis Flare Questionnaire

    Bartlett, Susan J; Barbic, Skye P; Bykerk, Vivian P

    2017-01-01

    -FQ), and the voting results at OMERACT 2016. METHODS: Classic and modern psychometric methods were used to assess reliability, validity, sensitivity, factor structure, scoring, and thresholds. Interviews with patients and clinicians also assessed content validity, utility, and meaningfulness of RA-FQ scores. RESULTS......: People with RA in observational trials in Canada (n = 896) and France (n = 138), and an RCT in the Netherlands (n = 178) completed 5 items (11-point numerical rating scale) representing RA Flare core domains. There was moderate to high evidence of reliability, content and construct validity...... to identify and measure RA flares. Its review through OMERACT Filter 2.0 shows evidence of reliability, content and construct validity, and responsiveness. These properties merit its further validation as an outcome for clinical trials....

  18. The development of Assessment of SpondyloArthritis international Society classification criteria for axial spondyloarthritis (part II): validation and final selection

    Rudwaleit, M.; van der Heijde, D.; Landewé, R.; Listing, J.; Akkoc, N.; Brandt, J.; Braun, J.; Chou, C. T.; Collantes-Estevez, E.; Dougados, M.; Huang, F.; Gu, J.; Khan, M. A.; Kirazli, Y.; Maksymowych, W. P.; Mielants, H.; Sørensen, I. J.; Ozgocmen, S.; Roussou, E.; Valle-Oñate, R.; Weber, U.; Wei, J.; Sieper, J.

    2009-01-01

    To validate and refine two sets of candidate criteria for the classification/diagnosis of axial spondyloarthritis (SpA). All Assessment of SpondyloArthritis international Society (ASAS) members were invited to include consecutively new patients with chronic (> or =3 months) back pain of unknown

  19. Analysis of the gamma criteria validation of dosimetric for VMAT; Analisis de los criterios gamma de validacion de dosimetrias para VMAT

    Sanchez Carrasco, M.; Marti Asenjo, J.; Torres Pozas, S.; Madan Rodriguez, C.; Luque Japon, L.; Godoy Cazorla, J.; Martin Olica, R.

    2013-07-01

    The simultaneous use of the variable elements of the patients, make it necessary to add a specific quality control for each treatment in addition to the quality controls newspapers of the machine. Likewise, the absence of an international or academic standard that a procedure for the validation of these treatments, justify the study of possible criteria for validation. Mannequins and computer programs used in this respect support a variety of analytical methods for the validation of the reproduction of the treatment. These methods of analysis are evaluated according to their sensitivity and specificity. (Author)

  20. Extended criteria and predictors in college admission: Exploring the structure of study success and investigating the validity of domain knowledge

    OLGA KUNINA

    2007-06-01

    Full Text Available The utility of aptitude tests and intelligence measures in the prediction of the success in college is one of the empirically best supported results in ability research. However, the structure of the criterion “study success” has not been appropriately investigated so far. Moreover, it remains unclear which aspect of intelligence – fluid intelligence or crystallized intelligence – has the major impact on the prediction. In three studies we have investigated the dimensionality of the criterion achievements as well as the relative contributions of competing ability predictors. In the first study, the dimensionality of college grades was explored in a sample of 629 alumni. A measurement model with two correlated latent factors distinguishing undergraduate college grades on the one hand from graduate college grades on the other hand had the best fit to the data. In the second study, a group of 179 graduate students completed a Psychology knowledge test and provided available college grades in undergraduate studies. A model separating a general latent factor for Psychology knowledge from a nested method factor for college grades, and a second nested factor for “experimental orientation” had the best fit to the data. In the third study the predictive power of domain specific knowledge tests in Mathematics, English, and Biology was investigated. A sample of 387 undergraduate students in this prospective study additionally completed a compilation of fluid intelligence tests. The results of this study indicate as expected that: a ability measures are incrementally predictive over school grades in predicting exam grades; and b that knowledge tests from relevant domains were incrementally predictive over fluid intelligence. The results of these studies suggest that criteria for college admission tests deserve and warrant more attention, and that domain specific ability indicators can contribute to the predictive validity of established

  1. Real external predictivity of QSAR models: how to evaluate it? Comparison of different validation criteria and proposal of using the concordance correlation coefficient.

    Chirico, Nicola; Gramatica, Paola

    2011-09-26

    The main utility of QSAR models is their ability to predict activities/properties for new chemicals, and this external prediction ability is evaluated by means of various validation criteria. As a measure for such evaluation the OECD guidelines have proposed the predictive squared correlation coefficient Q(2)(F1) (Shi et al.). However, other validation criteria have been proposed by other authors: the Golbraikh-Tropsha method, r(2)(m) (Roy), Q(2)(F2) (Schüürmann et al.), Q(2)(F3) (Consonni et al.). In QSAR studies these measures are usually in accordance, though this is not always the case, thus doubts can arise when contradictory results are obtained. It is likely that none of the aforementioned criteria is the best in every situation, so a comparative study using simulated data sets is proposed here, using threshold values suggested by the proponents or those widely used in QSAR modeling. In addition, a different and simple external validation measure, the concordance correlation coefficient (CCC), is proposed and compared with other criteria. Huge data sets were used to study the general behavior of validation measures, and the concordance correlation coefficient was shown to be the most restrictive. On using simulated data sets of a more realistic size, it was found that CCC was broadly in agreement, about 96% of the time, with other validation measures in accepting models as predictive, and in almost all the examples it was the most precautionary. The proposed concordance correlation coefficient also works well on real data sets, where it seems to be more stable, and helps in making decisions when the validation measures are in conflict. Since it is conceptually simple, and given its stability and restrictiveness, we propose the concordance correlation coefficient as a complementary, or alternative, more prudent measure of a QSAR model to be externally predictive.

  2. Updating the Psoriatic Arthritis (PsA) Core Domain Set: A Report from the PsA Workshop at OMERACT 2016.

    Orbai, Ana-Maria; de Wit, Maarten; Mease, Philip J; Callis Duffin, Kristina; Elmamoun, Musaab; Tillett, William; Campbell, Willemina; FitzGerald, Oliver; Gladman, Dafna D; Goel, Niti; Gossec, Laure; Hoejgaard, Pil; Leung, Ying Ying; Lindsay, Chris; Strand, Vibeke; van der Heijde, Désirée M; Shea, Bev; Christensen, Robin; Coates, Laura; Eder, Lihi; McHugh, Neil; Kalyoncu, Umut; Steinkoenig, Ingrid; Ogdie, Alexis

    2017-10-01

    To include the patient perspective in accordance with the Outcome Measures in Rheumatology (OMERACT) Filter 2.0 in the updated Psoriatic Arthritis (PsA) Core Domain Set for randomized controlled trials (RCT) and longitudinal observational studies (LOS). At OMERACT 2016, research conducted to update the PsA Core Domain Set was presented and discussed in breakout groups. The updated PsA Core Domain Set was voted on and endorsed by OMERACT participants. We conducted a systematic literature review of domains measured in PsA RCT and LOS, and identified 24 domains. We conducted 24 focus groups with 130 patients from 7 countries representing 5 continents to identify patient domains. We achieved consensus through 2 rounds of separate surveys with 50 patients and 75 physicians, and a nominal group technique meeting with 12 patients and 12 physicians. We conducted a workshop and breakout groups at OMERACT 2016 in which findings were presented and discussed. The updated PsA Core Domain Set endorsed with 90% agreement by OMERACT 2016 participants included musculoskeletal disease activity, skin disease activity, fatigue, pain, patient's global assessment, physical function, health-related quality of life, and systemic inflammation, which were recommended for all RCT and LOS. These were important, but not required in all RCT and LOS: economic cost, emotional well-being, participation, and structural damage. Independence, sleep, stiffness, and treatment burden were on the research agenda. The updated PsA Core Domain Set was endorsed at OMERACT 2016. Next steps for the PsA working group include evaluation of PsA outcome measures and development of a PsA Core Outcome Measurement Set.

  3. Comparison of DSM-IV versus proposed DSM-5 diagnostic criteria for eating disorders: reduction of eating disorder not otherwise specified and validity.

    Keel, Pamela K; Brown, Tiffany A; Holm-Denoma, Jill; Bodell, Lindsay P

    2011-09-01

    Revised Eating Disorder (ED) diagnostic criteria have been proposed for the Diagnostic and Statistical Manual (DSM)-5 to reduce the preponderance of eating disorder not otherwise specified (EDNOS) and increase the validity of diagnostic groups. This article compares DSM-IV and proposed DSM-5 diagnostic criteria on number of EDNOS cases and validity. Participants (N = 397; 91% female) completed structured clinical interviews in a two-stage epidemiological study of EDs. Interviewers did not follow standard skip rules, making it possible to evaluate alternative ED diagnostic criteria. Using DSM-IV versus DSM-5 criteria, 34 (14%) versus 48 (20%) had anorexia nervosa, 43 (18%) versus 44 (18%) had bulimia nervosa, and 163 (68%) had EDNOS versus 20 (8%) had binge eating disorder (BED), and 128 (53%) had EDNOS, respectively, reflecting a significant decrease in EDNOS. Validation analyses supported significant differences among groups with some improvement associated with delineation of BED. Proposed revisions to EDs in the DSM-5 significantly reduced reliance on EDNOS without loss of information. Copyright © 2011 Wiley Periodicals, Inc.

  4. Validation criteria of an internal dosimetry laboratory in vivo; Criterios para la validacion de un laboratorio de dosimetria interna in vivo

    Alfaro L, M. de las M., E-mail: mercedes.alfaro@inin.gob.mx [ININ, Carretera Mexico-Toluca s/n, 52750 Ocoyoacac, Estado de Mexico (Mexico)

    2014-10-15

    People working with radioactive materials, under certain circumstances (e.g. not using the proper protective equipment, an incident not covered, etc.) could be incorporated into the body. The radiation protection programs include direct measurement methods -in vivo- or indirect -in vitro- or both, to know that radioactive material is incorporated into the body. The monitoring measurements of internal contamination or (Radio-bioassay) are carried out with the purpose of determining the amount of radioactive material incorporated in the body; estimate the effective dose and committed dose; management administration of radiation protection; appropriate medical management; and to provide the data necessary for the legal requirements and the preservation of records. The measurement methods used in the monitoring of internal contamination must be validated by the combination of the following processes: calibration, using standards reference materials and/or simulators; execute systematic research, using control samples; and intercomparison between laboratories and performance tests. In this paper the validation criteria of an internal dosimetry laboratory in vivo are presented following the information provided by the standard ANSI N13-30-1996 and ISO/TEC 17025-2005 as are the criteria of facilities, staff training, interpretation of measurements, performance criteria for monitoring of internal contamination in vivo, results reporting and records retention. Thereby we achieve standardized quantitative performance criteria of truthfulness, accuracy and detection limit and a consensus on statistical definitions to establish the validation plan of a monitoring laboratory of internal contamination in vivo. (Author)

  5. Psychometric properties of the OARSI/OMERACT osteoarthritis pain and functional impairment scales: ICOAP, KOOS-PS and HOOS-PS.

    Ruyssen-Witrand, A; Fernandez-Lopez, C J; Gossec, L; Anract, P; Courpied, J P; Dougados, M

    2011-01-01

    To evaluate the psychometric properties of the OARSI-OMERACT questionnaires in comparison to the existing validated scales. Consecutive hip or knee osteoarthritis patients consulting in an orthopedic department were enrolled in the study. Data collected were pain using the Intermittent and Constant Osteoarthritis Pain (ICOAP), a Numeric Rating Scale (NRS), the Western Ontario McMaster Universities' Osteoarthritis Index (WOMAC) pain subscale, the Lequesne pain subscale; functional impairment using the Knee disability and Osteoarthritis Outcome Score-Physical Function Shortform (KOOS-PS), the Hip disability and Osteoarthritis Outcome Score-Physical Function Shortform (HOOS-PS), a NRS, the WOMAC function sub-scale, the Lequesne function subscale. Validity was assessed by calculating the Spearman's correlation coefficient between all the scales. Reliability was assessed in out-patients with stable disease comparing the data collected within 2 weeks using the intra-class correlation coefficient (ICC). Responsiveness was assessed on the data from hospitalised patients prior to and 12 weeks after a total joint replacement (TJR) using the standardised response mean. Three hundred patients (mean age=68 years, females=62%, hip OA=57%) were included. There was a moderate to good correlation between ICOAP, KOOS-PS, HOOS-PS and the WOMAC, NRS and Lequesne scales. Reliability of the ICOAP hip OA HOOS-PS and KOOS-PS was good (ICC range 0.80-0.81) whereas it was moderate for knee ICOAP (ICC=0.65). Responsiveness of the ICOAP, KOOS-PS and HOOS-PS 12 weeks after TJR was comparable to responsiveness of other scales (SRM range: 0.54-1.82). The psychometric properties of the ICOAP, KOOS-PS and HOOS-PS were comparable to those of the WOMAC, Lequesne and NRS.

  6. Validation of the Gambling Disorder Screening Questionnaire, a self-administered diagnostic questionnaire for gambling disorder based on the DSM-5 criteria.

    Villella, Corrado; Pascucci, Marco; de Waure, Chiara; Bellomo, Antonello; Conte, Gianluigi

    2016-01-01

    The DSM-5 has modified the diagnostic criteria for gambling disorder, compared to the fourth edition of the manual; new diagnostic instruments are therefore needed. This study evaluated the psychometric characteristics of the Gambling Disorder Screening Questionnaire (GDSQ), a self-report questionnaire based on the DSM-IV and DSM-5 criteria for Gambling Disorder, measuring its validity, internal consistency, and submitting the questionnaire to a principal components analysis. 71 patients from a gambling disorder outpatient clinic and 70 controls were evaluated with the GDSQ, the South Oaks Gambling Screen (SOGS), and a psychiatric interview. The test showed a good sensibility, specificity, internal consistency, concurrent validity with the SOGS. The exclusion of the “illegal acts” item, and the lowering of the cut-off score to four positive items, as suggested by the DSM-5 criteria, improved the test sensibility and internal consistency. The GDSQ can be considered a useful screening test for Gambling Disorder. Furthermore, this study confirms the improved diagnostic accuracy of the criteria listed in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders, compared to the previous edition.

  7. Validation of the MDS research criteria for prodromal Parkinson's disease: Longitudinal assessment in a REM sleep behavior disorder (RBD) cohort.

    Fereshtehnejad, Seyed-Mohammad; Montplaisir, Jacques Y; Pelletier, Amelie; Gagnon, Jean-François; Berg, Daniela; Postuma, Ronald B

    2017-06-01

    Recently, the International Parkinson and Movement Disorder Society introduced the prodromal criteria for PD. Objectives Our study aimed to examine diagnostic accuracy of the criteria as well as the independence of prodromal markers to predict conversion to PD or dementia with Lewy bodies. This prospective cohort study was performed on 121 individuals with rapid eye movement sleep behavior disorder who were followed annually for 1 to 12 years. Using data from a comprehensive panel of prodromal markers, likelihood ratio and post-test probability of the criteria were calculated at baseline and during each follow-up visit. Forty-eight (39.7%) individuals with rapid eye movement sleep behavior disorder converted to PD/dementia with Lewy bodies. The prodromal criteria had 81.3% sensitivity and 67.9% specificity for conversion to PD/dementia with Lewy bodies at 4-year follow-up. One year before conversion, sensitivity was 100%. The criteria predicted dementia with Lewy bodies with even higher accuracy than PD without dementia at onset. Those who met the threshold of prodromal criteria at baseline had significantly more rapid conversion into a neurodegenerative state (4.8 vs. 9.1 years; P conversion time in a rapid eye movement sleep behavior disorder cohort, with high sensitivity and high specificity with long follow-up. Prodromal markers influence the overall likelihood ratio independently, allowing them to be reliably multiplied. Defining additional markers with high likelihood ratio, further studies with longitudinal assessment and testing thresholds in different target populations will improve the criteria. © 2017 International Parkinson and Movement Disorder Society. © 2017 International Parkinson and Movement Disorder Society.

  8. Development of responder criteria for multicomponent non-pharmacological treatment in fibromyalgia.

    Vervoort, Vera M; Vriezekolk, Johanna E; van den Ende, Cornelia H

    2017-01-01

    There is a need to identify individual treatment success in patients with fibromyalgia (FM) who received non-pharmacological treatment. The present study described responder criteria for multicomponent non-pharmacological treatment in FM, and estimated and compared their sensitivity and specificity. Candidate responder sets were 1) identified in literature; and 2) formulated by expert group consensus. All candidate responder sets were tested in a cohort of 129 patients with FM receiving multicomponent non-pharmacological treatment. We used two gold standards (both therapist's and patient's perspective), assessed at six months after the start of treatment. Seven responder sets were defined (three identified in literature and four formulated by expert group consensus), and comprised combinations of domains of 1) pain; 2) fatigue; 3) patient global assessment (PGA); 4) illness perceptions; 5) limitations in activities of daily living (ADL); and 6) sleep. The sensitivity and specificity of literature-based responder sets (n=3) ranged between 17%-99% and 15%-95% respectively, whereas the expert-based responder sets (n=4) performed slightly better with regard to sensitivity (range 41%-81%) and specificity (range 50%-96%). Of the literature-based responder sets the OMERACT-OARSI responder set with patient's gold standard performed best (sensitivity 63%, specificity 75% and ROC area = 0.69). Overall, the expert-based responder set comprising the domains illness perceptions and limitations in ADL with patient's gold standard performed best (sensitivity 47%, specificity 96% and ROC area = 0.71). We defined sets of responder criteria for multicomponent non-pharmacological treatment in fibromyalgia. Further research should focus on the validation of those sets with acceptable performance.

  9. Improving selection of markers in nutrition research: evaluation of the criteria proposed by the ILSI Europe Marker Validation Initiative.

    Calder, Philip C; Boobis, Alan; Braun, Deborah; Champ, Claire L; Dye, Louise; Einöther, Suzanne; Greyling, Arno; Matthys, Christophe; Putz, Peter; Wopereis, Suzan; Woodside, Jayne V; Antoine, Jean-Michel

    2017-06-01

    The conduct of high-quality nutrition research requires the selection of appropriate markers as outcomes, for example as indicators of food or nutrient intake, nutritional status, health status or disease risk. Such selection requires detailed knowledge of the markers, and consideration of the factors that may influence their measurement, other than the effects of nutritional change. A framework to guide selection of markers within nutrition research studies would be a valuable tool for researchers. A multidisciplinary Expert Group set out to test criteria designed to aid the evaluation of candidate markers for their usefulness in nutrition research and subsequently to develop a scoring system for markers. The proposed criteria were tested using thirteen markers selected from a broad range of nutrition research fields. The result of this testing was a modified list of criteria and a template for evaluating a potential marker against the criteria. Subsequently, a semi-quantitative system for scoring a marker and an associated template were developed. This system will enable the evaluation and comparison of different candidate markers within the same field of nutrition research in order to identify their relative usefulness. The ranking criteria of proven, strong, medium or low are likely to vary according to research setting, research field and the type of tool used to assess the marker and therefore the considerations for scoring need to be determined in a setting-, field- and tool-specific manner. A database of such markers, their interpretation and range of possible values would be valuable to nutrition researchers.

  10. Validation of criteria for the definition of transient lower esophageal sphincter relaxations using high-resolution manometry.

    Roman, S; Holloway, R; Keller, J; Herbella, F; Zerbib, F; Xiao, Y; Bernard, L; Bredenoord, A J; Bruley des Varannes, S; Chen, M; Fox, M; Kahrilas, P J; Mittal, R K; Penagini, R; Savarino, E; Sifrim, D; Wu, J; Decullier, E; Pandolfino, J E; Mion, F

    2017-02-01

    Criteria for transient lower esophageal sphincter relaxations (TLESRs) are well-defined for Dentsleeve manometry. As high-resolution manometry (HRM) is now the gold standard to assess esophageal motility, our aim was to propose a consensus definition of TLESRs using HRM. Postprandial esophageal HRM combined with impedance was performed in 10 patients with gastroesophageal reflux disease. Transient lower esophageal sphincter relaxations identification was performed by 17 experts using a Delphi process. Four investigators then characterized TLESR candidates that achieved 100% agreement (TLESR events) and those that achieved less than 25% agreement (non-events) after the third round. Logistic regression and decision tree analysis were used to define optimal diagnostic criteria. All diagnostic criteria were more frequently encountered in the 57 TLESR events than in the 52 non-events. Crural diaphragm (CD) inhibition and LES relaxation duration >10 seconds had the highest predictive value to identify TLESR. Based on decision tree analysis, reflux on impedance, esophageal shortening, common cavity, upper esophageal sphincter relaxation without swallow and secondary peristalsis were alternate diagnostic criteria. Using HRM, TLESR might be defined as LES relaxation occurring in absence of swallowing, lasting more than 10 seconds and associated with CD inhibition. © 2016 John Wiley & Sons Ltd.

  11. Validity of Alcohol Use Disorder Identification Test-Korean Revised Version for Screening Alcohol Use Disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Criteria.

    Chang, Jung Wei; Kim, Jong Sung; Jung, Jin Gyu; Kim, Sung Soo; Yoon, Seok Joon; Jang, Hak Sun

    2016-11-01

    The Alcohol Use Disorder Identification Test (AUDIT) has been widely used to identify alcohol use disorder (AUD). This study evaluated the validity of the AUDIT-Korean revised version (AUDIT-KR) for screening AUD according to Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria. This research was conducted with 443 subjects who visited the Chungnam National University Hospital for a comprehensive medical examination. All subjects completed the demographic questionnaire and AUDIT-KR without assistance. Subjects were divided into two groups according to DSM-5 criteria: an AUD group, which included patients that fit the criteria for AUD (120 males and 21 females), and a non-AUD group, which included 146 males and 156 females that did not meet AUD criteria. The appropriate cut-off values, sensitivity, specificity, and positive and negative predictive values of the AUDIT-KR were evaluated. The mean±standard deviation AUDIT-KR scores were 10.32±7.48 points in males and 3.23±4.42 points in females. The area under the receiver operating characteristic curve (95% confidence interval, CI) of the AUDIT-KR for identifying AUD was 0.884 (0.840-0.920) in males and 0.962 (0.923-0.985) in females. The optimal cut-off value of the AUDIT-KR was 10 points for males (sensitivity, 81.90%; specificity, 81.33%; positive predictive value, 77.2%; negative predictive value, 85.3%) and 5 points for females (sensitivity, 100.00%; specificity, 88.54%; positive predictive value, 52.6%; negative predictive value, 100.0%). The AUDIT-KR has high reliability and validity for identifying AUD according to DSM-5 criteria.

  12. Validation of a French version of the Sleep Condition Indicator: a clinical screening tool for insomnia disorder according to DSM-5 criteria.

    Bayard, Sophie; Lebrun, Cindy; Maudarbocus, Khaalid Hassan; Schellaert, Vanessa; Joffre, Alicia; Ferrante, Esther; Le Louedec, Marie; Cournoulat, Alice; Gely-Nargeot, Marie-Christine; Luik, Annemarie I

    2017-12-01

    Insomnia disorder is frequent in the population, yet there is no French screening instrument available that is based on the updated DSM-5 criteria. We evaluated the validity and reliability of the French version of an insomnia screening instrument based on DSM-5 criteria, the Sleep Condition Indicator, in a population-based sample of adults. A total of 366 community-dwelling participants completed a face-to-face clinical interview to determine insomnia disorder against DSM-5 criteria and several questionnaires including the French Sleep Condition Indicator version. Three-hundred and twenty-nine participants completed the Sleep Condition Indicator again after 1 month. Statistical analyses were performed to determine the reliability, construct validity, divergent validity and temporal stability of the French translation of the Sleep Condition Indicator. In addition, an explanatory factor analysis was performed to assess the underlying structure. The internal consistency (α = 0.87) and temporal stability (r = 0.86, P French Sleep Condition Indicator were high. When using the previously defined cut-off value of ≤ 16, the area under the receiver operating characteristic curve was 0.93 with a sensitivity of 95% and a specificity of 75%. Additionally, good construct and divergent validity were demonstrated. The factor analyses showed a two-factor structure with a focus on sleep and daytime effects. The French version of the Sleep Condition Indicator demonstrates satisfactory psychometric properties while being a useful instrument in detecting cases of insomnia disorder, consistent with features of DSM-5, in the general population. © 2017 European Sleep Research Society.

  13. Validation of the Ten-Item Internet Gaming Disorder Test (IGDT-10) and evaluation of the nine DSM-5 Internet Gaming Disorder criteria.

    Király, Orsolya; Sleczka, Pawel; Pontes, Halley M; Urbán, Róbert; Griffiths, Mark D; Demetrovics, Zsolt

    2017-01-01

    The inclusion of Internet Gaming Disorder (IGD) in the DSM-5 (Section 3) has given rise to much scholarly debate regarding the proposed criteria and their operationalization. The present study's aim was threefold: to (i) develop and validate a brief psychometric instrument (Ten-Item Internet Gaming Disorder Test; IGDT-10) to assess IGD using definitions suggested in DSM-5, (ii) contribute to ongoing debate regards the usefulness and validity of each of the nine IGD criteria (using Item Response Theory [IRT]), and (iii) investigate the cut-off threshold suggested in the DSM-5. An online gamer sample of 4887 gamers (age range 14-64years, mean age 22.2years [SD=6.4], 92.5% male) was collected through Facebook and a gaming-related website with the cooperation of a popular Hungarian gaming magazine. A shopping voucher of approx. 300 Euros was drawn between participants to boost participation (i.e., lottery incentive). Confirmatory factor analysis and a structural regression model were used to test the psychometric properties of the IGDT-10 and IRT analysis was conducted to test the measurement performance of the nine IGD criteria. Finally, Latent Class Analysis along with sensitivity and specificity analysis were used to investigate the cut-off threshold proposed in the DSM-5. Analysis supported IGDT-10's validity, reliability, and suitability to be used in future research. Findings of the IRT analysis suggest IGD is manifested through a different set of symptoms depending on the level of severity of the disorder. More specifically, "continuation", "preoccupation", "negative consequences" and "escape" were associated with lower severity of IGD, while "tolerance", "loss of control", "giving up other activities" and "deception" criteria were associated with more severe levels. "Preoccupation" and "escape" provided very little information to the estimation IGD severity. Finally, the DSM-5 suggested threshold appeared to be supported by our statistical analyses. IGDT-10 is

  14. Validity and reliability problems with patient global as a component of the ACR/EULAR remission criteria as used in clinical practice.

    Masri, Karim R; Shaver, Timothy S; Shahouri, Shadi H; Wang, Shirley; Anderson, James D; Busch, Ruth E; Michaud, Kaleb; Mikuls, Ted R; Caplan, Liron; Wolfe, Frederick

    2012-06-01

    To investigate what factors influence patient global health assessment (PtGlobal), and how those factors and the reliability of PtGlobal affect the rate, reliability, and validity of recently published American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) rheumatoid arthritis (RA) remission criteria when used in clinical practice. We examined consecutive patients with RA in clinical practice and identified 77 who met ACR/EULAR joint criteria for remission (≤ 1 swollen joint and ≤ 1 tender joint). We evaluated factors associated with a PtGlobal > 1, because a PtGlobal ≤ 1 defined ACR/EULAR remission in this group of patients who had already met ACR/EULAR joint criteria. Of the 77 patients examined, only 17 (22.1%) had PtGlobal ≤ 1 and thus fully satisfied ACR/EULAR criteria. A large proportion of patients not in remission by ACR/EULAR criteria had high PtGlobal related to noninflammatory issues, including low back pain, fatigue, and functional limitations, and a number of patients clustered in the range of PtGlobal > 1 and ≤ 2. However, the minimal detectable difference for PtGlobal was 2.3. In addition, compared with a PtGlobal severity score, a PtGlobal activity score was 3.3% less likely to be abnormal (> 1). Noninflammatory factors contribute to the level of PtGlobal and result in the exclusion of many patients who would otherwise be in "true" remission according to the ACR/EULAR definition. Reliability problems associated with PtGlobal can also result in misclassification, and may explain the observation of low longterm remission rates in RA. As currently constituted, the use of the ACR/EULAR remission criteria in clinical practice appears to be problematic.

  15. Reliability and validity of the DSM-IV-TR and proposed DSM-5 criteria for pedophilia: Implications for the ICD-11 and the next DSM.

    Seto, Michael C; Fedoroff, J Paul; Bradford, John M; Knack, Natasha; Rodrigues, Nicole C; Curry, Susan; Booth, Brad; Gray, Jonathan; Cameron, Colin; Bourget, Dominique; Messina, Sarina; James, Elizabeth; Watson, Diane; Gulati, Sanjiv; Balmaceda, Rufino; Ahmed, Adekunle G

    We tested the inter-rater reliability and criterion-related validity of the DSM-IV-TR pedophilia diagnosis and proposed DSM-5 pedohebephilia diagnosis in a sample of 79 men who had committed child pornography offenses, contact sexual offenses against children, or who were referred because of concerns about whether they had a sexual interest in children. Participants were evaluated by two independent psychiatrists with an interview and questionnaire regarding demographic characteristics, sexual history, and self-reported sexual interests; they also completed phallometric and visual reaction time testing. Kappa was .59 for ever meeting DSM-IV-TR criteria for pedophilia and .52 for ever meeting the proposed DSM-5 criteria for pedohebephilia. Ever meeting DSM-IV-TR diagnosis was significantly related to self-reported index of sexual interest in children (highest AUC=.81, 95% CI=.70-.91, pDSM-5 "diagnosis" was similarly related to self-report (AUC=.84, 95% CI=.74-.94, pDSM-5 criteria, we believe these results suggest the revision of DSM-5 and development of ICD-11 could benefit from drawing on the current DSM-5 criteria, which are essentially the same as DSM-IV-TR except for a distinction between having a paraphilia (the interest) and a paraphilic disorder (the paraphilia plus clinically significant distress or impairment). Copyright © 2016. Published by Elsevier Ltd.

  16. Definitions and validation criteria for biomarkers and surrogate endpoints: development and testing of a quantitative hierarchical levels of evidence schema

    Lassere, Marissa N.; Johnson, Kent R.; Boers, Maarten; Tugwell, Peter; Brooks, Peter; Simon, Lee; Strand, Vibeke; Conaghan, Philip G.; Ostergaard, Mikkel; Maksymowych, Walter P.; Landewe, Robert; Bresnihan, Barry; Tak, Paul-Peter; Wakefield, Richard; Mease, Philip; Bingham, Clifton O.; Hughes, Michael; Altman, Doug; Buyse, Marc; Galbraith, Sally; Wells, George

    2007-01-01

    OBJECTIVE: There are clear advantages to using biomarkers and surrogate endpoints, but concerns about clinical and statistical validity and systematic methods to evaluate these aspects hinder their efficient application. Our objective was to review the literature on biomarkers and surrogates to

  17. Definitions and validation criteria for biomarkers and surrogate endpoints: development and testing of a quantitative hierarchical levels of evidence schema

    Lassere, Marissa N; Johnson, Kent R; Boers, Maarten

    2007-01-01

    endpoints, and leading indicators, a quantitative surrogate validation schema was developed and subsequently evaluated at a stakeholder workshop. RESULTS: The search identified several classification schema and definitions. Components of these were incorporated into a new quantitative surrogate validation...... of the National Institutes of Health definitions of biomarker, surrogate endpoint, and clinical endpoint was useful. CONCLUSION: Further development and application of this schema provides incentives and guidance for effective biomarker and surrogate endpoint research, and more efficient drug discovery...... are then applied if there is serious counterevidence. A total score (0 to 15) determines the level of evidence, with Level 1 the strongest and Level 5 the weakest. It was proposed that the term "surrogate" be restricted to markers attaining Levels 1 or 2 only. Most stakeholders agreed that this operationalization...

  18. Definitions and validation criteria for biomarkers and surrogate endpoints: development and testing of a quantitative hierarchical levels of evidence schema

    Lassere, Marissa N; Johnson, Kent R; Boers, Maarten

    2007-01-01

    endpoints, and leading indicators, a quantitative surrogate validation schema was developed and subsequently evaluated at a stakeholder workshop. RESULTS: The search identified several classification schema and definitions. Components of these were incorporated into a new quantitative surrogate validation...... level of evidence schema that evaluates biomarkers along 4 domains: Target, Study Design, Statistical Strength, and Penalties. Scores derived from 3 domains the Target that the marker is being substituted for, the Design of the (best) evidence, and the Statistical strength are additive. Penalties...... of the National Institutes of Health definitions of biomarker, surrogate endpoint, and clinical endpoint was useful. CONCLUSION: Further development and application of this schema provides incentives and guidance for effective biomarker and surrogate endpoint research, and more efficient drug discovery...

  19. Predicting Persistent Back Symptoms by Psychosocial Risk Factors: Validity Criteria for the ÖMPSQ and the HKF-R 10 in Germany.

    E Riewe

    Full Text Available 10% of all individuals in Germany develop persistent symptoms due to nonspecific back pain (NSBP causing up to 90% of direct and indirect expenses for health care systems. Evidence indicates a strong relationship between chronic nonspecific back pain and psychosocial risk factors. The Örebro Musculoskeletal Pain Screening Questionnaire (ÖMPSQ and the German Heidelberger Kurzfragebogen Rückenschmerz (HKF-R 10 are deemed valid in prediction of persistent pain, functional loss or amount of sick leave. This study provides and discusses validity criteria for these questionnaires using ROC-curve analyses. Quality measurements included sensitivity and specificity, likelihood-ratio related test-efficiencies and clinical utility in regard to predictive values.265 patients recruited from primary and secondary care units completed both questionnaires during the same timeframe. From the total, 133 patients returned a 6-month follow-up questionnaire to assess the validity criteria for outcomes of pain, function and sick leave.Based on heterogeneous cut-offs for the ÖMPSQ, sensitivity and specificity were moderate for outcome of pain (72%/75%. Very high sensitivity was observed for function (97%/57% and high specificity for sick leave (63%/85%. The latter also applied to the HKF-R 10 (pain 50%/84%. Proportions between sensitivity and specificity were unbalanced except for the ÖMPSQ outcome of pain. Likelihood-ratios and positive predictive values ranged from low to moderate.Although the ÖMPSQ may be considered useful in identification of long-term functional loss or pain, over- and underestimation of patients at risk of chronic noncspecific back pain led to limited test-efficiencies and clinical utility for both questionnaires. Further studies are required to quantify the predictive validity of both questionnaires in Germany.

  20. Definitions and validation criteria for biomarkers and surrogate endpoints: development and testing of a quantitative hierarchical levels of evidence schema.

    Lassere, Marissa N; Johnson, Kent R; Boers, Maarten; Tugwell, Peter; Brooks, Peter; Simon, Lee; Strand, Vibeke; Conaghan, Philip G; Ostergaard, Mikkel; Maksymowych, Walter P; Landewe, Robert; Bresnihan, Barry; Tak, Paul-Peter; Wakefield, Richard; Mease, Philip; Bingham, Clifton O; Hughes, Michael; Altman, Doug; Buyse, Marc; Galbraith, Sally; Wells, George

    2007-03-01

    There are clear advantages to using biomarkers and surrogate endpoints, but concerns about clinical and statistical validity and systematic methods to evaluate these aspects hinder their efficient application. Our objective was to review the literature on biomarkers and surrogates to develop a hierarchical schema that systematically evaluates and ranks the surrogacy status of biomarkers and surrogates; and to obtain feedback from stakeholders. After a systematic search of Medline and Embase on biomarkers, surrogate (outcomes, endpoints, markers, indicators), intermediate endpoints, and leading indicators, a quantitative surrogate validation schema was developed and subsequently evaluated at a stakeholder workshop. The search identified several classification schema and definitions. Components of these were incorporated into a new quantitative surrogate validation level of evidence schema that evaluates biomarkers along 4 domains: Target, Study Design, Statistical Strength, and Penalties. Scores derived from 3 domains the Target that the marker is being substituted for, the Design of the (best) evidence, and the Statistical strength are additive. Penalties are then applied if there is serious counterevidence. A total score (0 to 15) determines the level of evidence, with Level 1 the strongest and Level 5 the weakest. It was proposed that the term "surrogate" be restricted to markers attaining Levels 1 or 2 only. Most stakeholders agreed that this operationalization of the National Institutes of Health definitions of biomarker, surrogate endpoint, and clinical endpoint was useful. Further development and application of this schema provides incentives and guidance for effective biomarker and surrogate endpoint research, and more efficient drug discovery, development, and approval.

  1. Defining surgical criteria for empty nose syndrome: Validation of the office-based cotton test and clinical interpretability of the validated Empty Nose Syndrome 6-Item Questionnaire.

    Thamboo, Andrew; Velasquez, Nathalia; Habib, Al-Rahim R; Zarabanda, David; Paknezhad, Hassan; Nayak, Jayakar V

    2017-08-01

    The validated Empty Nose Syndrome 6-Item Questionnaire (ENS6Q) identifies empty nose syndrome (ENS) patients. The unvalidated cotton test assesses improvement in ENS-related symptoms. By first validating the cotton test using the ENS6Q, we define the minimal clinically important difference (MCID) score for the ENS6Q. Individual case-control study. Fifteen patients diagnosed with ENS and 18 controls with non-ENS sinonasal conditions underwent office cotton placement. Both groups completed ENS6Q testing in three conditions-precotton, cotton in situ, and postcotton-to measure the reproducibility of ENS6Q scoring. Participants also completed a five-item transition scale ranging from "much better" to "much worse" to rate subjective changes in nasal breathing with and without cotton placement. Mean changes for each transition point, and the ENS6Q MCID, were then calculated. In the precotton condition, significant differences (P < .001) in all ENS6Q questions between ENS and controls were noted. With cotton in situ, nearly all prior ENS6Q differences normalized between ENS and control patients. For ENS patients, the changes in the mean differences between the precotton and cotton in situ conditions compared to postcotton versus cotton in situ conditions were insignificant among individuals. Including all 33 participants, the mean change in the ENS6Q between the parameters "a little better" and "about the same" was 4.25 (standard deviation [SD] = 5.79) and -2.00 (SD = 3.70), giving an MCID of 6.25. Cotton testing is a validated office test to assess for ENS patients. Cotton testing also helped to determine the MCID of the ENS6Q, which is a 7-point change from the baseline ENS6Q score. 3b. Laryngoscope, 127:1746-1752, 2017. © 2017 The American Laryngological, Rhinological and Otological Society, Inc.

  2. The 2010 American college of rheumatology fibromyalgia survey diagnostic criteria and symptom severity scale is a valid and reliable tool in a French speaking fibromyalgia cohort

    Fitzcharles Mary-Ann

    2012-09-01

    Full Text Available Abstract Background Fibromyalgia (FM is a pain condition with associated symptoms contributing to distress. The Fibromyalgia Survey Diagnostic Criteria and Severity Scale (FSDC is a patient-administered questionnaire assessing diagnosis and symptom severity. Locations of body pain measured by the Widespread Pain Index (WPI, and the Symptom Severity scale (SS measuring fatigue, unrefreshing sleep, cognitive and somatic complaints provide a score (0–31, measuring a composite of polysymptomatic distress. The reliability and validity of the translated French version of the FSDC was evaluated. Methods The French FSDC was administered twice to 73 FM patients, and was correlated with measures of symptom status including: Fibromyalgia Impact Questionnaire (FIQ, Health Assessment Questionnaire (HAQ, McGill Pain Questionnaire (MPQ, and a visual analogue scale (VAS for global severity and pain. Test-retest reliability, internal consistency, and construct validity were evaluated. Results Test-retest reliability was between .600 and .888 for the 25 single items of the FSDC, and .912 for the total FSDC, with all correlations significant (p  Conclusions The French FSDC is a valid instrument in French FM patients with reliability and construct validity. It is easily completed, simple to score, and has the potential to become the standard for measurement of polysymptomatic distress in FM.

  3. Studying the impact of industry type validation criteria to Legal customers of Bank Saderat Iran using data envelopment analysis

    Alireza Rajabipour Meybodi

    2013-08-01

    Full Text Available One of the problems of today's banking system is overdue loans. The basic strategy for solving this problem is creating a credit rating system of customers. Financial ratios extracted from financial statements of companies have long been considered as one of the useful tools used for evaluating companies by individuals to predict future conditions. Therefore, in this study, ranking of companies in each industry has been discussed using Data Envelopment Analysis (DEA and a number of inputs and outputs such as financial ratios and other important characteristics from the viewpoint of professors and credit experts. Then, ratings of the inputs and outputs (credit criteria have been identified to distinguish and compare the types of industries using sensitivity analysis. Finally, the values of inputs and outputs have been studied for different industries. The research approach can be used by banks in credit risk management for customers.

  4. Validation of organ procurement and transplant network (OPTN)/united network for organ sharing (UNOS) criteria for imaging diagnosis of hepatocellular carcinoma.

    Fowler, Kathryn J; Karimova, E Jane; Arauz, Anthony R; Saad, Nael E; Brunt, Elizabeth M; Chapman, William C; Heiken, Jay P

    2013-06-27

    Imaging diagnosis of hepatocellular carcinoma (HCC) presents an important pathway for transplant exception points and priority for cirrhotic patients. The purpose of this retrospective study is to evaluate the validity of the new Organ Procurement and Transplant Network (OPTN) classification system on patients undergoing transplantation for HCC. One hundred twenty-nine patients underwent transplantation for HCC from April 14, 2006 to April 18, 2011; a total of 263 lesions were reported as suspicious for HCC on pretransplantation magnetic resonance imaging. Magnetic resonance imaging examinations were reviewed independently by two experienced radiologists, blinded to final pathology. Reviewers identified major imaging features and an OPTN classification was assigned to each lesion. Final proof of diagnosis was pathology on explant or necrosis along with imaging findings of ablation after transarterial chemoembolization. Application of OPTN imaging criteria in our population resulted in high specificity for the diagnosis of HCC. Sensitivity in diagnosis of small lesions (≥1 and based on preoperative imaging but would not have met criteria under the new system. Eleven percent of the patients not meeting OPTN criteria were found to have T2 stage tumor burden on pathology. The OPTN imaging policy introduces a high level of specificity for HCC but may decrease sensitivity for small lesions. Management may be impacted in a number of patients, potentially requiring longer surveillance periods or biopsy to confirm diagnosis.

  5. Developing and validating a perinatal depression screening tool in Kenya blending Western criteria with local idioms: A mixed methods study.

    Green, Eric P; Tuli, Hawa; Kwobah, Edith; Menya, D; Chesire, Irene; Schmidt, Christina

    2018-03-01

    Routine screening for perinatal depression is not common in most primary health care settings. The U.S. Preventive Services Task Force only recently updated their recommendation on depression screening to specifically recommend screening during the pre- and postpartum periods. While practitioners in high-income countries can respond to this new recommendation by implementing one of several existing depression screening tools developed in Western contexts, such as the Edinburgh Postnatal Depression Scale (EPDS) or the Patient Health Questionnaire-9 (PHQ-9), these tools lack strong evidence of cross-cultural equivalence, validity for case finding, and precision in measuring response to treatment in developing countries. Thus, there is a critical need to develop and validate new screening tools for perinatal depression that can be used by lay health workers, primary health care personnel, and patients. Working in rural Kenya, we used free listing, card sorting, and item analysis methods to develop a locally-relevant screening tool that blended Western psychiatric concepts with local idioms of distress. We conducted a validation study with a random sample of 193 pregnant women and new mothers to test the diagnostic accuracy of this scale along with the EPDS and PHQ-9. The sensitivity/specificity of the EPDS and PHQ-9 was estimated to be 0.70/0.72 and 0.70/0.73, respectively. This compared to sensitivity/specificity of 0.90/0.90 for a new 9-item locally-developed tool called the Perinatal Depression Screening (PDEPS). Across these three tools, internal consistency reliability ranged from 0.77 to 0.81 and test-retest reliability ranged from 0.57 to 0.67. The prevalence of depression ranges from 5.2% to 6.2% depending on the clinical reference standard. The EPDS and PHQ-9 are valid and reliable screening tools for perinatal depression in rural Western Kenya, the PDEPS may be a more useful alternative. At less than 10%, the prevalence of depression in this region appears

  6. A stress-based fracture criteria validated on mixed microstructures of ferrite and bainite over a range of stress triaxialities

    Golling, Stefan, E-mail: stefan.golling@ltu.se [Luleå University of Technology, SE 971 87 Luleå (Sweden); Östlund, Rickad [Gestamp HardTech, Ektjärnsvägen 5, SE 973 45 Luleå (Sweden); Oldenburg, Mats [Luleå University of Technology, SE 971 87 Luleå (Sweden)

    2016-09-30

    Hot stamping is a sequential process for formation and heat-treatment of sheet metal components with superior mechanical properties. By applying different cooling rates, the microstructural composition and thus the material properties of steel can be designed. By controlling the cooling rate in different sections of a blank, the material properties can be tailored depending on the desired toughness. Under continuous cooling, various volume fractions of ferrite and bainite are formed depending on the rate of cooling. This paper focuses on the ductile fracture behavior of a thin sheet metal made of low-alloyed boron steel with varying amounts of ferrite and bainite. An experimental setup was applied in order to produce microstructures with different volume fractions of ferrite and bainite. In total, five different test specimen geometries, representing different stress triaxialities, were heat treated and tensile tested. Through full-field measurements, flow curves extending beyond necking and the equivalent plastic strain to fracture were determined. Experimental results were further investigated using a mean-field homogenization scheme combined with local fracture criteria. The mean-field homogenization scheme comprises the influence of microstructure composition and stress triaxiality with usable accuracy, connoting auspicious possibilities for constitutive modeling of hot-stamped components.

  7. Societal and individual burden of illness among fibromyalgia patients in France: Association between disease severity and OMERACT core domains

    Perrot Serge

    2012-02-01

    Full Text Available Abstract Background Patients with fibromyalgia (FM report widespread pain, fatigue, and other functional limitations. This study aimed to provide an assessment of the burden of illness associated with FM in France and its association with disease severity and core domains as defined by Outcome Measures in Rheumatology Clinical Trials (OMERACT for FM. Methods This cross-sectional, observational study recruited patients with a prior diagnosis of FM from 18 community-based physician offices in France. Patients completed questions about FM impact (Fibromyalgia-Impact Questionnaire [FIQ], core symptoms (defined by OMERACT, health-related quality of life (EQ-5D, current overall health status (rated on a scale from 0 to 100, productivity, treatment satisfaction, and out-of-pocket expenses related to FM. Site staff recorded patients' treatment and health resource use based on medical record review. Costs were extrapolated from 4-week patient-reported data and 3-month clinical case report form data and calculated in 2008 Euros using a societal perspective. Tests of significance used the Kruskal-Wallis test or Fisher's Exact test where P Results Eighty-eight patients (mean 55.2 y; female:male 74:14 were recruited. The majority of patients (84.1% were prescribed medications for FM. Patients mainly described medications as a little/not at all effective (40.0% or somewhat effective (52.9%. Current Overall Health rating was 52.9 (± 17.8 and FIQ total score was 54.8 (± 17.3. FIQ total score was used to define FM severity, and 17 patients scored 0- Conclusions In a sample of 88 patients with FM from France, we found that FM poses a substantial economic and human burden on patients and society. FM severity level was significantly associated with patients' health status and core symptom domains.

  8. Does training novices to criteria and does rapid acquisition of skills on laparoscopic simulators have predictive validity or are we just playing video games?

    Hogle, Nancy J; Widmann, Warren D; Ude, Aku O; Hardy, Mark A; Fowler, Dennis L

    2008-01-01

    To determine whether LapSim training (version 3.0; Surgical Science Ltd, Göteborg, Sweden) to criteria for novice PGY1 surgical residents had predictive validity for improvement in the performance of laparoscopic cholecystectomy. In all, 21 PGY1 residents performed laparoscopic cholecystectomies in pigs after minimal training; their performance was evaluated by skilled laparoscopic surgeons using the validated tool GOALS (global operative assessment of laparoscopic operative skills: depth perception, bimanual dexterity, efficiency, tissue handling, and overall competence). From the group, 10 residents trained to competency on the LapSim Basic Skills Programs (camera navigation, instrument navigation, coordination, grasping, lifting and grasping, cutting, and clip applying). All 21 PGY1 residents again performed laparoscopic cholecystectomies on pigs; their performance was again evaluated by skilled laparoscopic surgeons using GOALS. Additionally, we studied the rate of learning to determine whether the slow or fast learners on the LapSim performed equivalently when performing actual cholecystectomies in pigs. Finally, 6 categorical residents were tracked, and their clinical performance on all of the laparoscopic cholecystectomies in which they were "surgeon, junior" was prospectively evaluated using the GOALS criteria. We found a statistical improvement of depth perception in the operative performance of cholecystectomies in pigs in the group trained on the LapSim. In the other 4 domains, a trend toward improvement was observed. No correlation between being a fast learner and the ultimate skill was demonstrated in the clinical performance of laparoscopic cholecystectomies. We did find that the fast learners on LapSim all were past or current video game players ("gamers"); however, that background did not translate into better clinical performance. Using current criteria, we doubt that the time and effort spent training novice PGY1 Surgical Residents on the basic

  9. Errors in the universal and sufficient heuristic criteria of estimating validity limits of geometric optics and of the geometric theory of diffraction

    Borovikov, V.A.; Kinber, B.E.

    1988-01-01

    The heuristic criteria (HC) of validity of geometric optics (GO) and of the geometric theory of diffraction (GTD), suggested in [2-7, 13, 14] and based on identifying the physical volume occupied by the ray with the Fresnel volume (FV) introduced in these papers (i.e., the envelope of the first Fresnel zone), are analyzed. Numerous examples of HC invalidity are given, as well as the reasons. In particular, HC provide an incorrect answer for all GO problems with caustics, since in these problems there always exists a ray, whose FV is nonlocal and covers the FV of other rays. The HC are shown to be unsuitable for multiple ray GTD problems, as well as for the simplest problems of diffraction of a cylindrical wave by a half-plane and of a plane wave by a curved half-plane

  10. Toward a Valid Animal Model of Bipolar Disorder: How the Research Domain Criteria Help Bridge the Clinical-Basic Science Divide.

    Cosgrove, Victoria E; Kelsoe, John R; Suppes, Trisha

    2016-01-01

    Bipolar disorder is a diagnostically heterogeneous disorder, although mania emerges as a distinct phenotype characterized by elevated mood and increased activity or energy. While bipolar disorder's cyclicity is difficult to represent in animals, models of mania have begun to decode its fundamental underlying neurobiology. When psychostimulants such as amphetamine or cocaine are administered to rodents, a resulting upsurge of motor activity is thought to share face and predictive validity with mania in humans. Studying black Swiss mice, which inherently exhibit proclivity for reward seeking and risk taking, also has yielded some insight. Further, translating the biology of bipolar disorder in humans into animal models has led to greater understanding of roles for candidate biological systems such as the GRIK2 and CLOCK genes, as well as the extracellular signal-related kinase pathway involved in the pathophysiology of the illness. The National Institute of Mental Health Research Domain Criteria initiative seeks to identify building blocks of complex illnesses like bipolar disorder in hopes of uncovering the neurobiology of each, as well as how each fits together to produce syndromes like bipolar disorder or why so many mental illnesses co-occur together. Research Domain Criteria-driven preclinical models of isolated behaviors and domains involved in mania and bipolar disorder will ultimately inform movement toward nosology supported by neurobiology. Copyright © 2016 Society of Biological Psychiatry. All rights reserved.

  11. Steps to standardization and validation of hippocampal volumetry as a biomarker in clinical trials and diagnostic criteria for Alzheimer’s disease

    Jack, Clifford R; Barkhof, Frederik; Bernstein, Matt A; Cantillon, Marc; Cole, Patricia E; DeCarli, Charles; Dubois, Bruno; Duchesne, Simon; Fox, Nick C; Frisoni, Giovanni B; Hampel, Harald; Hill, Derek LG; Johnson, Keith; Mangin, Jean-François; Scheltens, Philip; Schwarz, Adam J; Sperling, Reisa; Suhy, Joyce; Thompson, Paul M; Weiner, Michael; Foster, Norman L

    2012-01-01

    Background The promise of Alzheimer’s disease (AD) biomarkers has led to their incorporation in new diagnostic criteria and in therapeutic trials; however, significant barriers exist to widespread use. Chief among these is the lack of internationally accepted standards for quantitative metrics. Hippocampal volumetry is the most widely studied quantitative magnetic resonance imaging (MRI) measure in AD and thus represents the most rational target for an initial effort at standardization. Methods and Results The authors of this position paper propose a path toward this goal. The steps include: 1) Establish and empower an oversight board to manage and assess the effort, 2) Adopt the standardized definition of anatomic hippocampal boundaries on MRI arising from the EADC-ADNI hippocampal harmonization effort as a Reference Standard, 3) Establish a scientifically appropriate, publicly available Reference Standard Dataset based on manual delineation of the hippocampus in an appropriate sample of subjects (ADNI), and 4) Define minimum technical and prognostic performance metrics for validation of new measurement techniques using the Reference Standard Dataset as a benchmark. Conclusions Although manual delineation of the hippocampus is the best available reference standard, practical application of hippocampal volumetry will require automated methods. Our intent is to establish a mechanism for credentialing automated software applications to achieve internationally recognized accuracy and prognostic performance standards that lead to the systematic evaluation and then widespread acceptance and use of hippocampal volumetry. The standardization and assay validation process outlined for hippocampal volumetry is envisioned as a template that could be applied to other imaging biomarkers. PMID:21784356

  12. Headache characteristics of uncomplicated intracranial vertebral artery dissection and validation of ICHD-3 beta diagnostic criteria for headache attributed to intracranial artery dissection.

    Kim, Jae-Gyum; Choi, Jeong-Yoon; Kim, Sung Un; Jung, Jin-Man; Kwon, Do-Young; Park, Moon Ho; Oh, Kyungmi

    2015-05-01

    Headache may be a warning sign of subsequent stroke in patients with vertebral artery dissection (VAD). Even though the headache characteristics of VAD have been described predominantly in patients with extracranial VAD and neurological complications, headache semiology is not well known in patients with uncomplicated intracranial vertebral artery dissection (ICVAD). In the present study, we attempt to identify the headache semiology that characterizes ICVAD and validate the revised version of the International Classification of Headache Disorders (ICHD-3 beta) criteria for headache attributed to intracranial artery dissection. Six patients with neurologically uncomplicated ICVAD presented at a participating medical center, and eight similar patients were reviewed in the literature. Combining these data, we analyzed headache characteristics of patients with uncomplicated ICVAD according to their pain onset and duration, nature, intensity, location, aggravating and relieving factors, associated symptoms, response to medication, and prognosis. Headache in uncomplicated ICVAD usually has an acute mode of onset (11/14) and persistent (10/14) temporal feature. Pain that has a throbbing quality (nine of 14) and severe intensity (13/14) on the ipsilesional (10/14) and occipitonuchal area (12/14) is a headache prototype in ICVAD. Additionally, headache was intensified by head flexion and rotation (three of six), and relieved by head extension and supine positioning (five of six). Headache of all patients in the present study fulfilled the ICHD-3 beta criteria. Headache semiology of uncomplicated ICVAD is mostly homogenous in the present study. These characteristics may be helpful in the diagnosis of uncomplicated ICVAD. © International Headache Society 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

  13. Validity and Reliability of the U.S. National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

    Dueck, Amylou C.; Mendoza, Tito R.; Mitchell, Sandra A.; Reeve, Bryce B.; Castro, Kathleen M.; Rogak, Lauren J.; Atkinson, Thomas M.; Bennett, Antonia V.; Denicoff, Andrea M.; O'Mara, Ann M.; Li, Yuelin; Clauser, Steven B.; Bryant, Donna M.; Bearden, James D.; Gillis, Theresa A.; Harness, Jay K.; Siegel, Robert D.; Paul, Diane B.; Cleeland, Charles S.; Schrag, Deborah; Sloan, Jeff A.; Abernethy, Amy P.; Bruner, Deborah W.; Minasian, Lori M.; Basch, Ethan

    2016-01-01

    Importance Symptomatic adverse events (AEs) in cancer trials are currently reported by clinicians using the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE). To integrate the patient perspective, the NCI developed a patient-reported outcomes version of the CTCAE (PRO-CTCAE) to capture symptomatic AEs directly from patients. Objective To assess the construct validity, test-retest reliability, and responsiveness of PRO-CTCAE items. Design Participants completed PRO-CTCAE items on tablet computers in clinic waiting rooms at two visits 1-6 weeks apart. A subset completed PRO-CTCAE items during an additional visit one business day after the first visit. Setting Nine U.S. cancer centers and community oncology practices. Participants 975 adult cancer patients undergoing outpatient chemotherapy and/or radiation enrolled between January 2011 and February 2012. Eligibility required participants to read English and be without clinically significant cognitive impairment. Main Outcome(s) and Measure(s) Primary comparators were clinician-reported Eastern Cooperative Oncology Group Performance Status (ECOG PS) and the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (QLQ-C30). Results 940/975 (96%) and 852/940 (91%) participants completed PRO-CTCAE items at each visit. 938/940 (99.8%) participants (53% female, median age 59, 32% high school education or less, 17% ECOG PS 2-4) reported having at least one symptom. All PRO-CTCAE items had at least one correlation in the expected direction with a QLQ-C30 scale (111/124 P<.05). Stronger correlations were seen between PRO-CTCAE items and conceptually-related QLQ-C30 domains. Scores for 94/124 PRO-CTCAE items were higher in the ECOG PS 2-4 versus 0-1 group (58/124 P<.05). Overall, 119/124 items met at least one construct validity criterion. Test-retest reliability was acceptable for 36/49 pre-specified items (median intra-class correlation coefficient

  14. Analysis of 2000 cases treated with gamma knife surgery: validating eligibility criteria for a prospective multi-institutional study of stereotactic radiosurgery alone for treatment of patients with 1-10 brain metastases (JLGK0901) in Japan

    Higuchi, Yoshinori; Nagano, Osamu; Sato, Yasunori; Yamamoto, Masaaki; Ono, Junichi; Saeki, Naokatsu; Miyakawa, Akifumi; Hirai, Tatsuo

    2012-01-01

    Objective The Japan Leksell Gamma Knife (JLGK) Society has conducted a prospective multi-institute study (JLGK0901, UNIN000001812) for selected patients in order to prove the effectiveness of stereotactic radiosurgery (SRS) alone using the gamma knife (GK) for 1-10 brain lesions. Herein, we verify the validity of 5 major patient selection criteria for the JLGK0901 trial. Materials and Methods Between 1998 and 2010, 2246 consecutive cases with 10352 brain metastases treated with GK were analyzed to determine the validity of the following 5 major JLGK0901 criteria; 1) 1-10 brain lesions, 2) less than 10 cm3 volume of the largest tumor, 3) no more than 15 cm3 total tumor volume, 4) no cerebrospinal fluid (CSF) dissemination, 5) Karnofsky performance status (KPS) score ≥70. Results For cases with >10 brain metastases, salvage treatments for new lesions were needed more frequently. The tumor control rate for lesions larger than 10 cm3 was significantly lower than that of tumors 15 cm3 total tumor volume or positive magnetic resonance imaging findings of CSF were significantly poorer. Outcomes in cases with KPS <70 were significantly poorer in terms of OS. Conclusion Our retrospective results of 2246 GK-treated cases verified the validity of the 5 major JLGK0901 criteria. The inclusion criteria for the JLGK0901 study are appearently good indications for SRS. PMID:29296339

  15. Operational validation of a multi-period and multi-criteria model conditioning approach for the prediction of rainfall-runoff processes in small forest catchments

    Choi, H.; Kim, S.

    2012-12-01

    Limestone. The study is progressed based on the followings. Firstly, hydrological time series of each catchment are sampled and clustered into multi-period having distinctly different temporal characteristics, and secondly, behavioural parameter distributions are determined in each multi-period based on the specification of multi-criteria model performance measures. Finally, behavioural parameter sets of each multi-period of single catchment are applied on the corresponding period of other catchments, and the cross-validations are conducted in this manner for all catchments The multi-period model conditioning approach is clearly effective to reduce the width of prediction limits, giving better model performance against the temporal variability of hydrological characteristics, and has enough potential to be the effective prediction tool for ungauged catchments. However, more advanced and continuous studies are needed to expand the application of this approach in prediction of hydrological responses in ungauged catchments,

  16. Examining the similarities and differences of OMERACT core sets using the ICF: first step towards an improved domain specification and development of an item pool to measure functioning and health.

    Escorpizo, Reuben; Boers, Maarten; Stucki, Gerold; Boonen, Annelies

    2011-08-01

    To contribute to the discussion on a common approach for domain selection in the Outcomes in Rheumatology Clinical Trials (OMERACT) process. First, this article reports on the consistency in the selection and names of the domains of the current OMERACT core set, and next on the comparability of the specifications of concepts that are relevant within the domains. For this purpose, a convenience sample of 4 OMERACT core sets was used: rheumatoid arthritis (RA), psoriatic arthritis (PsA), longitudinal observational studies (LOS) in rheumatology, and ankylosing spondylitis (AS). Domains from the different core sets were compared directly. To be able to compare the specific content of the domains, the concepts contained in the questionnaires that were considered or proposed to measure the domains were identified and linked to the category of the International Classification of Functioning, Disability, and Health (ICF) that best fit that construct. Large differences in the domains, and lack of domain definitions, were noted among the 4 OMERACT core sets. When comparing the concepts in the questionnaires that represent the domains, core sets differed also in the number and type of constructs that were addressed within each of the domains. Especially for the specification of the concepts within the domains Discomfort and Disability, the ICF proved to be useful as external reference to classify the different constructs. Our exercise suggests that the OMERACT process could benefit from a standardized approach to select, define, and specify domains, and demonstrated that the ICF is useful for further classification of the more specific concepts of "what to measure" within the domains. A clear definition and classification of domains and their specification can be useful as a starting point to build a pool of items that could then be used to develop new instruments to assess functioning and health for rheumatological conditions.

  17. Agreement for depression diagnosis between DSM-IV-TR criteria, three validated scales, oncologist assessment, and psychiatric clinical interview in elderly patients with advanced ovarian cancer

    Rhondali W

    2015-07-01

    Anxiety Depression Scale, the distress thermometer, the mood thermometer, and OA. The interview guide for PCI was constructed from three validated scales: the GDS, the Hamilton Depression Rating Scale, and the Montgomery Asberg Depression Rating Scale (MADRS. The Diagnostic and Statistical Manual of Mental Disorders, fourth edition, revised (DSM criteria for depression were used as a gold standard.Results: Out of 109 patients enrolled at 21 centers, 99 (91% completed all the assessments. Patient characteristics were: mean age 78, performance status ≥2: 47 (47%. Thirty six patients (36% were identified as depressed by the PCI versus 15 (15% identified by DSM. We found moderate agreement for depression identification between DSM and GDS (κ=0.508 and PCI (κ=0.431 and high agreement with MADRS (κ=0.663. We found low or no agreement between DSM with the other assessment strategies, including OA (κ=-0.043. Identification according to OA (yes/no resulted in a false-negative rate of 87%. As a screening tool, GDS had the best sensitivity and specificity (94% and 80%, respectively.Conclusion: The use of validated tools, such as GDS, and collaboration between psychologists and oncologists are warranted to better identify emotional disorders in elderly women with AOC. Keywords: depression, elderly, cancer, screening, geriatric assessment

  18. DRUG EVALUATION AND DECISION MAKING IN CATALONIA: DEVELOPMENT AND VALIDATION OF A METHODOLOGICAL FRAMEWORK BASED ON MULTI-CRITERIA DECISION ANALYSIS (MCDA) FOR ORPHAN DRUGS.

    Gilabert-Perramon, Antoni; Torrent-Farnell, Josep; Catalan, Arancha; Prat, Alba; Fontanet, Manel; Puig-Peiró, Ruth; Merino-Montero, Sandra; Khoury, Hanane; Goetghebeur, Mireille M; Badia, Xavier

    2017-01-01

    The aim of this study was to adapt and assess the value of a Multi-Criteria Decision Analysis (MCDA) framework (EVIDEM) for the evaluation of Orphan drugs in Catalonia (Catalan Health Service). The standard evaluation and decision-making procedures of CatSalut were compared with the EVIDEM methodology and contents. The EVIDEM framework was adapted to the Catalan context, focusing on the evaluation of Orphan drugs (PASFTAC program), during a Workshop with sixteen PASFTAC members. The criteria weighting was done using two different techniques (nonhierarchical and hierarchical). Reliability was assessed by re-test. The EVIDEM framework and methodology was found useful and feasible for Orphan drugs evaluation and decision making in Catalonia. All the criteria considered for the development of the CatSalut Technical Reports and decision making were considered in the framework. Nevertheless, the framework could improve the reporting of some of these criteria (i.e., "unmet needs" or "nonmedical costs"). Some Contextual criteria were removed (i.e., "Mandate and scope of healthcare system", "Environmental impact") or adapted ("population priorities and access") for CatSalut purposes. Independently of the weighting technique considered, the most important evaluation criteria identified for orphan drugs were: "disease severity", "unmet needs" and "comparative effectiveness", while the "size of the population" had the lowest relevance for decision making. Test-retest analysis showed weight consistency among techniques, supporting reliability overtime. MCDA (EVIDEM framework) could be a useful tool to complement the current evaluation methods of CatSalut, contributing to standardization and pragmatism, providing a method to tackle ethical dilemmas and facilitating discussions related to decision making.

  19. Validation of the Infectious Diseases Society of America/American Thoracic Society criteria to predict severe community-acquired pneumonia caused by Streptococcus pneumoniae.

    Kontou, Paschalina; Kuti, Joseph L; Nicolau, David P

    2009-10-01

    Severe community-acquired pneumonia (CAP) is usually defined as pneumonia that requires intensive care unit (ICU) admission; the primary pathogen responsible for ICU admission is Streptococcus pneumoniae. In this study, the 2007 Infectious Diseases Society of America/American Thoracic Society (IDSA/ATS) consensus criteria for ICU admission were compared with other severity scores in predicting ICU admission and mortality. We retrospectively studied 158 patients with pneumococcal CAP (1999-2003). Clinical and laboratory features at the emergency department were recorded and used to calculate the 2007 IDSA/ATS rule, the 2001 ATS rule, 2 modified 2007 IDSA/ATS rules, the Pneumonia Severity Index (PSI), and the CURB (confusion, urea, respiratory rate, blood pressure) score. The sensitivity, specificity, positive predictive value, and negative predictive value (NPV) were assessed for the various indices. We also determined the criteria that were independently predictive of ICU admission and of mortality in our population. The 2007 IDSA/ATS criteria performed as well as the 2001 ATS rule in predicting ICU admission both demonstrated high sensitivity (90%) and NPV (97%). For the prediction of mortality, the best tool proved to be the PSI score (sensitivity, 95%; NPV, 99%). The variables associated with ICU admission in this patient population included tachypnea, confusion, Pao(2)/Fio(2) ratio of 250 or lower, and hypotension requiring fluid resuscitation. Mechanical ventilation and PSI class V were independently associated with mortality. This study confirms the usefulness of the new criteria in predicting severe CAP. The 2001 ATS criteria seem an attractive alternative because they are simple and as effective as the 2007 IDSA/ATS criteria.

  20. General criteria for validation of dosimetry methods in the context of a quality system ISO / IEC 17025; Criterios generales sobre validacion de metodos de dosimetria en el marco de un sistema de calidad ISO/IEC 17025

    Martin Garcia, R.; Navarro Bravo, T.

    2011-07-01

    The accreditation of a testing laboratory in accordance with ISO / IEC 17025 recognizes the technical competence of a laboratory to perform certain tests. One of the requirements of that rule states that laboratories must demonstrate that the methods used are valid and appropriate for the intended use and customer needs. This demonstration is accomplished through the process of validation of methods, defined in the rule it self as {sup c}onfirmation by examination and provision of objective evidence that the requirements for a particular purpose{sup .} The process of validating a test method should be well planned and documented, including the requirements under the applicable rules and criteria established by the laboratory to comply with these requirements.

  1. I know what you want to know: the impact of interviewees' ability to identify criteria on interview performance and construct-related validity

    Melchers, K.G.; Klehe, U.-C.; Richter, G.M.; Kleinmann, M.; König, C.J.; Lievens, F.

    2009-01-01

    The current study tested whether candidates' ability to identify the targeted interview dimensions fosters their interview success as well as the interviews' convergent and discriminant validity. Ninety-two interviewees participated in a simulated structured interview developed to measure three

  2. Criteria CSR

    Vovk, V.; Zateyshikova, O.

    2014-01-01

    In the article the theoretical aspects regarding criteria for assessing CSR proposed by A. Carroll, including: economic, legal, ethical, philanthropic. Based on this, it is proposed to characterize these criteria with respect to the interested parties (stakeholders), including: investors, shareholders suppliers, customers, employees, society and the state. This will make a qualitative assessment of the presence and depth using social responsibility in the company, as well as determine the ext...

  3. A Note on the Validity and Reliability of Multi-Criteria Decision Analysis for the Benefit-Risk Assessment of Medicines.

    Garcia-Hernandez, Alberto

    2015-11-01

    The comparative evaluation of benefits and risks is one of the most important tasks during the development, market authorization and post-approval pharmacovigilance of medicinal products. Multi-criteria decision analysis (MCDA) has been recommended to support decision making in the benefit-risk assessment (BRA) of medicines. This paper identifies challenges associated with bias or variability that practitioners may encounter in this field and presents solutions to overcome them. The inclusion of overlapping or preference-complementary criteria, which are frequent violations to the assumptions of this model, should be avoided. For each criterion, a value function translates the original outcomes into preference-related scores. Applying non-linear value functions to criteria defined as the risk of suffering a certain event during the study introduces specific risk behaviours in this prescriptive, rather than descriptive, model and is therefore a questionable practice. MCDA uses weights to compare the importance of the model criteria with each other; during their elicitation a frequent situation where (generally favourable) mild effects are directly traded off against low probabilities of suffering (generally unfavourable) severe effects during the study is known to lead to biased and variable weights and ought to be prevented. The way the outcomes are framed during the elicitation process, positively versus negatively for instance, may also lead to differences in the preference weights, warranting an appropriate justification during each implementation. Finally, extending the weighted-sum MCDA model into a fully inferential tool through a probabilistic sensitivity analysis is desirable. However, this task is troublesome and should not ignore that clinical trial endpoints generally are positively correlated.

  4. Reliability of ultrasound grading traditional score and new global OMERACT-EULAR score system (GLOESS): results from an inter- and intra-reading exercise by rheumatologists.

    Ventura-Ríos, Lucio; Hernández-Díaz, Cristina; Ferrusquia-Toríz, Diana; Cruz-Arenas, Esteban; Rodríguez-Henríquez, Pedro; Alvarez Del Castillo, Ana Laura; Campaña-Parra, Alfredo; Canul, Efrén; Guerrero Yeo, Gerardo; Mendoza-Ruiz, Juan Jorge; Pérez Cristóbal, Mario; Sicsik, Sandra; Silva Luna, Karina

    2017-12-01

    This study aims to test the reliability of ultrasound to graduate synovitis in static and video images, evaluating separately grayscale and power Doppler (PD), and combined. Thirteen trained rheumatologist ultrasonographers participated in two separate rounds reading 42 images, 15 static and 27 videos, of the 7-joint count [wrist, 2nd and 3rd metacarpophalangeal (MCP), 2nd and 3rd interphalangeal (IPP), 2nd and 5th metatarsophalangeal (MTP) joints]. The images were from six patients with rheumatoid arthritis, performed by one ultrasonographer. Synovitis definition was according to OMERACT. Scoring system in grayscale, PD separately, and combined (GLOESS-Global OMERACT-EULAR Score System) were reviewed before exercise. Reliability intra- and inter-reading was calculated with Cohen's kappa weighted, according to Landis and Koch. Kappa values for inter-reading were good to excellent. The minor kappa was for GLOESS in static images, and the highest was for the same scoring in videos (k 0.59 and 0.85, respectively). Excellent values were obtained for static PD in 5th MTP joint and for PD video in 2nd MTP joint. Results for GLOESS in general were good to moderate. Poor agreement was observed in 3rd MCP and 3rd IPP in all kinds of images. Intra-reading agreement were greater in grayscale and GLOESS in static images than in videos (k 0.86 vs. 0.77 and k 0.86 vs. 0.71, respectively), but PD was greater in videos than in static images (k 1.0 vs. 0.79). The reliability of the synovitis scoring through static images and videos is in general good to moderate when using grayscale and PD separately or combined.

  5. An evaluation of the predictive validity and inter-rater reliability of clinical diagnostic criteria for senile dementia of Lewy body type.

    McKeith, I G; Fairbairn, A F; Bothwell, R A; Moore, P B; Ferrier, I N; Thompson, P; Perry, R H

    1994-05-01

    Several recent autopsy studies suggest that senile dementia of Lewy body type (SDLT) may be the second most common neuropathologic cause of dementia in the elderly, accounting for 7 to 30% of all cases. Operational criteria for the antemortem clinical diagnosis of SDLT have already been proposed by our group. The performance of these is now examined by randomizing the case notes from a new series of SDLT, Alzheimer, and multi-infarct dementia patients for psychiatric assessment by four raters of varying clinical experience and blind to pathologic diagnosis. Using the SDLT criteria, the two most experienced raters agreed in 94% of cases (kappa = 0.87), with the least experienced rater agreeing in 78% (kappa = 0.50). Diagnostic specificity for SDLT was uniformly high (90.0 to 97.0%), with a mean sensitivity of detection of 74%, and was greater by the experienced (90.0%) than the least experienced (55%) clinician. The antemortem identification of SDLT patients can therefore be achieved with a high degree of diagnostic specificity using such operationalized criteria, although there remains a minority of patients who present with either "typical" Alzheimer-type symptoms or with paranoid or delusional symptoms in the absence of substantial cognitive impairment. Sensitivity to neuroleptics may be a useful diagnostic pointer in these patients.

  6. Validity of the histopathological criteria used for diagnosing dysplastic naevi. An interobserver study by the pathology subgroup of the EORTC Malignant Melanoma Cooperative Group.

    de Wit, P E; van't Hof-Grootenboer, B; Ruiter, D J; Bondi, R; Bröcker, E B; Cesarini, J P; Hastrup, N; Hou-Jensen, K; MacKie, R M; Scheffer, E

    1993-01-01

    Ten (dermato)pathologists studied 50 cutaneous melanocytic lesions including common naevocellular naevi, dysplastic naevi (DN), melanomas in situ and invasive primary melanomas, with emphasis on the histological criteria of DN. Using a standardised form, 20 defined histopathological features were scored (semi)quantitatively. Concordance of diagnosis, efficacy and reproducibility of features were investigated. DN were distinguished well from the other entities (mean Po 0.87). Agreement on the degree of atypia of DN was low. The reproducibility of the scoring was best for the following features: irregular nests, lymphohistiocytic infiltrate, marked junctional proliferation and large nuclei. The overall values of these features to discriminate between DN and non-DN were better than for the other features studied. Using the presence of at least three of the four features as a condition for the diagnosis of DN, values for sensitivity, specificity and positive and negative predictive values were 0.86, 0.91, 0.96 and 0.73, respectively. On the basis of the results these features seem best suited as histological criteria for the diagnosis of DN.

  7. Establishing diagnostic cut-off criteria for the COBAS AmpliPrep/COBAS TaqMan HIV-1 Qualitative test through validation against the Amplicor DNA test v1.5 for infant diagnosis using dried blood spots.

    Maritz, Jean; Preiser, Wolfgang; van Zyl, Gert U

    2012-02-01

    As antibody testing cannot confirm HIV-1 infection in children less than 18 months of age, diagnosis in these children depends on nucleic acid testing. The COBAS(®) AmpliPrep/COBAS(®) TaqMan(®) (CAP/CTM, Roche(®) Molecular Systems, Inc., Branchburg, NJ) HIV-1 Qualitative test is a total nucleic acid real-time PCR assay utilising whole EDTA blood or dried blood spots (DBS), which recently replaced the Roche(®) AMPLICOR(®) DNA test v1.5 (Amplicor) as the diagnostic HIV PCR assay in many South African laboratories. For the Amplicor assay, stringent diagnostic criteria were previously formulated for the local population, and a comparison reported the CAP/CTM's sensitivity at 99.7% and specificity at 100% for both sample types compared to these Amplicor criteria. To validate the assay prior to introduction in our laboratory and to define stringent diagnostic cut-off criteria. Whole EDTA blood samples from patients younger than 18 months sent for routine HIV-1 diagnosis were tested by Amplicor, and positive results were confirmed from DBS. CAP/CTM assays were subsequently performed from DBS. The CAP/CTM had a sensitivity of 98.8% and a specificity of 97.1%, but a positive predictive value (PPV) of only 78.7% compared to the Amplicor assay. Samples positive by CAP/CTM but negative by Amplicor displayed poor amplification curves compared to concordant positive samples. Upon re-testing those with sufficient material available by CAP/CTM, all showed negative results. The decreased PPV may either be due to false positive CAP/CTM results, or increased sensitivity compared to the Amplicor assay. Criteria were formulated for defining presumed false-positive results. Copyright © 2011 Elsevier B.V. All rights reserved.

  8. Numerical multi-criteria optimization methods for alloy design. Development of new high strength nickel-based superalloys and experimental validation

    Rettig, Ralf; Mueller, Alexander; Ritter, Nils C.; Singer, Robert F. [Institute of Science and Technology of Metals, Department of Materials Science and Engineering, University of Erlangen (Germany)

    2016-07-01

    A new approach for the design of optimum balanced metallic alloys is presented. It is based on a mathematical multi-criteria optimization method which uses different property models to predict the alloy behavior in dependency of composition. These property models are mostly based on computational thermodynamics (CALPHAD-method). The full composition range of the alloying elements can be considered using these models. In alloy design usually several contradicting goals have to be fulfilled. This is handled by the calculation of so-called Pareto-fronts. The aim of our approach is to guide the experimental research towards new alloy compositions that have a high probability of having very good properties. Consequently the number of required test alloys can be massively reduced. The approach will be demonstrated for the computer-aided design of a new Re-free superalloy with nearly identical creep strength as that of Re-containing superalloys. Our starting point for the design was to maintain the good properties of the gamma prime-phase in well-known alloys like CMSX-4 and to maximize the solid solution strengthening of W and Mo. The presented experimental measurements proof the excellent properties.

  9. Multiresidue confirmatory method for determination of quinolones in milk by HPLC: method development and validation according to the criteria of Commission Decision 2002/657/EC

    Federica Ostorero

    2013-04-01

    Full Text Available Veterinary drugs have become an integral part of the livestock production and play an important role in maintaining animal welfare. The use of veterinary medicines may be cause of the presence of drug residues in animal food products if appropriate withdrawal periods are not respected or if contaminated feeds are used. This work presents the development of an high performance liquid chromatography with postcolumn fluorescence derivatization (HPLC-FLD method for the quantitative detection of eight quinolones – norfloxacin, ciprofloxacin, danofloxacin, enrofloxacin, difloxacin, oxolinic acid, nalidixic acid, and flumequine – in bovine milk. After deproteination and extraction with a metaphosphoric acid 1% w/v/methanol/acetonitrile (60/20/20 v/v/v solution, the sample is partially evaporated and cleaned up on a reversed phase solid phase extraction (SPE cartridge. The extract is analyzed using an HPLC-FLD. Mean recovery ranged between 65-88%. The method is validated as a confirmatory method according to Decision 2002/657/EC. All the verified parameters (linearity, selectivity/specificity, trueness, precision, CC, ruggedness and stability were satisfactory and the method is able to quantify all the analytes in milk in the concentration range 15-60 μg/Kg for danofloxacin and 25-150 μg/Kg for the other quinolones.

  10. Clinical validation of the C-VAT 2.0 assessment tool for gaming disorder: A sensitivity analysis of the proposed DSM-5 criteria and the clinical characteristics of young patients with 'video game addiction'.

    van Rooij, Antonius J; Schoenmakers, Tim M; van de Mheen, Dike

    2017-01-01

    Clinicians struggle with the identification of video gaming problems. To address this issue, a clinical assessment tool (C-VAT 2.0) was developed and tested in a clinical setting. The instrument allows exploration of the validity of the DSM-5 proposal for 'internet gaming disorder'. Using C-VAT 2.0, the current study provides a sensitivity analysis of the proposed DSM-5 criteria in a clinical youth sample (13-23years old) in treatment for video gaming disorder (N=32). The study also explores the clinical characteristics of these patients. The patients were all male and reported spending extensive amounts of time on video games. At least half of the patients reported playing online games (n=15). Comorbid problems were common (n=22) and included (social) anxiety disorders, PDD NOS, ADHD/ADD, Parent-Child relationship problem, and various types of depressive mood problems. The sensitivity of the test was good: results further show that the C-VAT correctly identified 91% of the sample at the proposed cut-off score of at least 5 out of 9 of the criteria. As our study did not include healthy, extreme gamers, we could not assess the specificity of the tool: future research should make this a priority. Using the proposed DSM-5 cut-off score, the C-VAT 2.0 shows preliminary validity in a sample of gamers in treatment for gaming disorder, but the discriminating value of the instrument should be studied further. In the meantime, it is crucial that therapists try to avoid false positives by using expert judgment of functional impairment in each case. Copyright © 2015 Elsevier Ltd. All rights reserved.

  11. Identification and validation of multiple cell surface markers of clinical-grade adipose-derived mesenchymal stromal cells as novel release criteria for good manufacturing practice-compliant production.

    Camilleri, Emily T; Gustafson, Michael P; Dudakovic, Amel; Riester, Scott M; Garces, Catalina Galeano; Paradise, Christopher R; Takai, Hideki; Karperien, Marcel; Cool, Simon; Sampen, Hee-Jeong Im; Larson, A Noelle; Qu, Wenchun; Smith, Jay; Dietz, Allan B; van Wijnen, Andre J

    2016-08-11

    Clinical translation of mesenchymal stromal cells (MSCs) necessitates basic characterization of the cell product since variability in biological source and processing of MSCs may impact therapeutic outcomes. Although expression of classical cell surface markers (e.g., CD90, CD73, CD105, and CD44) is used to define MSCs, identification of functionally relevant cell surface markers would provide more robust release criteria and options for quality control. In addition, cell surface expression may distinguish between MSCs from different sources, including bone marrow-derived MSCs and clinical-grade adipose-derived MSCs (AMSCs) grown in human platelet lysate (hPL). In this work we utilized quantitative PCR, flow cytometry, and RNA-sequencing to characterize AMSCs grown in hPL and validated non-classical markers in 15 clinical-grade donors. We characterized the surface marker transcriptome of AMSCs, validated the expression of classical markers, and identified nine non-classical markers (i.e., CD36, CD163, CD271, CD200, CD273, CD274, CD146, CD248, and CD140B) that may potentially discriminate AMSCs from other cell types. More importantly, these markers exhibit variability in cell surface expression among different cell isolates from a diverse cohort of donors, including freshly prepared, previously frozen, or proliferative state AMSCs and may be informative when manufacturing cells. Our study establishes that clinical-grade AMSCs expanded in hPL represent a homogeneous cell culture population according to classical markers,. Additionally, we validated new biomarkers for further AMSC characterization that may provide novel information guiding the development of new release criteria. Use of Autologous Bone Marrow Aspirate Concentrate in Painful Knee Osteoarthritis (BMAC): Clinicaltrials.gov NCT01931007 . Registered August 26, 2013. MSC for Occlusive Disease of the Kidney: Clinicaltrials.gov NCT01840540 . Registered April 23, 2013. Mesenchymal Stem Cell Therapy in Multiple

  12. Validation of a Knowledge Transfer Tool for the Knee Inflammation MRI Scoring System for Bone Marrow Lesions According to the OMERACT Filter

    Jaremko, Jacob L; Azmat, Omar; Lambert, Robert Gw

    2017-01-01

    grid within a Web-based interface to fit bones, then clicks or touches each region containing BML per slice, to score 1 if BML is present. Regional and total scores are automatically calculated. Outcomes include the interreader intraclass correlation coefficients (ICC) and the smallest detectable...

  13. Importance of Contextual Factors When Measuring Work Outcome in Ankylosing Spondylitis: A Systematic Review by the OMERACT Worker Productivity Group.

    Stolwijk, Carmen; Castillo-Ortiz, José-Dionisio; Gignac, Monique; Luime, Jolanda; Boonen, A

    2015-09-01

    To review the literature on contextual factors (CoFas) and their relationship to work outcomes in individuals with ankylosing spondylitis (AS). Articles that quantified the relationship between CoFas and employment status, sick leave, or presenteeism in individuals with AS were systematically identified. CoFas were classified into 5 domains for personal factors and 8 domains for environmental factors. We defined criteria for best-evidence synthesis for each CoFa domain based on the number of studies exploring that domain, and the quality of evidence of individual studies based on the risk of bias, adjustment of multivariable analyses for disease activity and physical function, and sample size. Twenty-five studies met our inclusion criteria: 20 addressed employment status, 6 examined sick leave, and 3 presenteeism. For employment, there was strong evidence for the role of age, moderate evidence for related skills/abilities, the absence of work accommodations, the nature of work and absence of workplace support, and poor evidence for the role of marital status. Evidence was insufficient for sex, education, and physical environment. For sick leave and presenteeism there were too few studies to perform a best-evidence synthesis for the role of CoFas. Using a newly proposed set of criteria for determining the best-evidence of the association between CoFa domains and work outcome, the following factors emerged: age, related skills/abilities, work accommodations, nature of work, and workplace support. In addition to disease-related variables, these CoFa domains seem important to include when designing and interpreting studies on work outcomes. © 2015, American College of Rheumatology.

  14. Analytical method for the identification and assay of 12 phthalates in cosmetic products: application of the ISO 12787 international standard "Cosmetics-Analytical methods-Validation criteria for analytical results using chromatographic techniques".

    Gimeno, Pascal; Maggio, Annie-Françoise; Bousquet, Claudine; Quoirez, Audrey; Civade, Corinne; Bonnet, Pierre-Antoine

    2012-08-31

    Esters of phthalic acid, more commonly named phthalates, may be present in cosmetic products as ingredients or contaminants. Their presence as contaminant can be due to the manufacturing process, to raw materials used or to the migration of phthalates from packaging when plastic (polyvinyl chloride--PVC) is used. 8 phthalates (DBP, DEHP, BBP, DMEP, DnPP, DiPP, DPP, and DiBP), classified H360 or H361, are forbidden in cosmetics according to the European regulation on cosmetics 1223/2009. A GC/MS method was developed for the assay of 12 phthalates in cosmetics, including the 8 phthalates regulated. Analyses are carried out on a GC/MS system with electron impact ionization mode (EI). The separation of phthalates is obtained on a cross-linked 5%-phenyl/95%-dimethylpolysiloxane capillary column 30 m × 0.25 mm (i.d.) × 0.25 mm film thickness using a temperature gradient. Phthalate quantification is performed by external calibration using an internal standard. Validation elements obtained on standard solutions, highlight a satisfactory system conformity (resolution>1.5), a common quantification limit at 0.25 ng injected, an acceptable linearity between 0.5 μg mL⁻¹ and 5.0 μg mL⁻¹ as well as a precision and an accuracy in agreement with in-house specifications. Cosmetic samples ready for analytical injection are analyzed after a dilution in ethanol whereas more complex cosmetic matrices, like milks and creams, are assayed after a liquid/liquid extraction using ter-butyl methyl ether (TBME). Depending on the type of cosmetics analyzed, the common limits of quantification for the 12 phthalates were set at 0.5 or 2.5 μg g⁻¹. All samples were assayed using the analytical approach described in the ISO 12787 international standard "Cosmetics-Analytical methods-Validation criteria for analytical results using chromatographic techniques". This analytical protocol is particularly adapted when it is not possible to make reconstituted sample matrices. Copyright © 2012

  15. [Primary childhood vasculitis new classification criteria

    Herlin, T.; Nielsen, Susan

    2008-01-01

    Primary vasculitis is seen in both adults and children, but some of the diseases like Kawasaki disease occur primarily in children. The Chapel Hill Classification Criteria for primary vasculitis refers to the size of vessels but has not been validated in children. Recently, new criteria...

  16. Proposed Diagnostic Criteria for Smartphone Addiction.

    Lin, Yu-Hsuan; Chiang, Chih-Lin; Lin, Po-Hsien; Chang, Li-Ren; Ko, Chih-Hung; Lee, Yang-Han; Lin, Sheng-Hsuan

    2016-01-01

    Global smartphone penetration has led to unprecedented addictive behaviors. The aims of this study are to develop diagnostic criteria of smartphone addiction and to examine the discriminative ability and the validity of the diagnostic criteria. We developed twelve candidate criteria for characteristic symptoms of smartphone addiction and four criteria for functional impairment caused by excessive smartphone use. The participants consisted of 281 college students. Each participant was systematically assessed for smartphone-using behaviors by psychiatrist's structured diagnostic interview. The sensitivity, specificity, and diagnostic accuracy of the candidate symptom criteria were analyzed with reference to the psychiatrists' clinical global impression. The optimal model selection with its cutoff point of the diagnostic criteria differentiating the smartphone addicted subjects from non-addicted subjects was then determined by the best diagnostic accuracy. Six symptom criteria model with optimal cutoff point were determined based on the maximal diagnostic accuracy. The proposed smartphone addiction diagnostic criteria consisted of (1) six symptom criteria, (2) four functional impairment criteria and (3) exclusion criteria. Setting three symptom criteria as the cutoff point resulted in the highest diagnostic accuracy (84.3%), while the sensitivity and specificity were 79.4% and 87.5%, respectively. We suggested determining the functional impairment by two or more of the four domains considering the high accessibility and penetration of smartphone use. The diagnostic criteria of smartphone addiction demonstrated the core symptoms "impaired control" paralleled with substance related and addictive disorders. The functional impairment involved multiple domains provide a strict standard for clinical assessment.

  17. Rett syndrome diagnostic criteria: lessons from the Natural History Study.

    Percy, Alan K; Neul, Jeffrey L; Glaze, Daniel G; Motil, Kathleen J; Skinner, Steven A; Khwaja, Omar; Lee, Hye-Seung; Lane, Jane B; Barrish, Judy O; Annese, Fran; McNair, Lauren; Graham, Joy; Barnes, Katherine

    2010-12-01

    Analysis of 819 participants enrolled in the Rett syndrome (RTT) Natural History Study validates recently revised diagnostic criteria. 765 females fulfilled 2002 consensus criteria for classic (653/85.4%) or variant (112/14.6%) RTT. All participants classified as classic RTT fulfilled each revised main criterion; supportive criteria were not uniformly present. All variant RTT participants met at least 3 of 6 main criteria in the 2002, 2 of 4 main criteria in the current format, and 5 of 11 supportive criteria in both. This analysis underscores the critical role of main criteria for classic RTT; variant RTT requires both main and supportive criteria.

  18. Proposed diagnostic criteria for internet addiction.

    Tao, Ran; Huang, Xiuqin; Wang, Jinan; Zhang, Huimin; Zhang, Ying; Li, Mengchen

    2010-03-01

    The objective of this study was to develop diagnostic criteria for internet addiction disorder (IAD) and to evaluate the validity of our proposed diagnostic criteria for discriminating non-dependent from dependent internet use in the general population. This study was conducted in three stages: the developmental stage (110 subjects in the survey group; 408 subjects in the training group), where items of the proposed diagnostic criteria were developed and tested; the validation stage (n = 405), where the proposed criteria were evaluated for criterion-related validity; and the clinical stage (n = 150), where the criteria and the global clinical impression of IAD were evaluated by more than one psychiatrist to determine inter-rater reliability. The proposed internet addiction diagnostic criteria consisted of symptom criterion (seven clinical symptoms of IAD), clinically significant impairment criterion (functional and psychosocial impairments), course criterion (duration of addiction lasting at least 3 months, with at least 6 hours of non-essential internet usage per day) and exclusion criterion (exclusion of dependency attributed to psychotic disorders). A diagnostic score of 2 + 1, where the first two symptoms (preoccupation and withdrawal symptoms) and at least one of the five other symptoms (tolerance, lack of control, continued excessive use despite knowledge of negative effects/affects, loss of interests excluding internet, and use of the internet to escape or relieve a dysphoric mood) was established. Inter-rater reliability was 98%. Our findings suggest that the proposed diagnostic criteria may be useful for the standardization of diagnostic criteria for IAD.

  19. Criteria for saturated magnetization loop

    Harres, A.; Mikhov, M.; Skumryev, V.; Andrade, A.M.H. de; Schmidt, J.E.; Geshev, J.

    2016-01-01

    Proper estimation of magnetization curve parameters is vital in studying magnetic systems. In the present article, criteria for discrimination non-saturated (minor) from saturated (major) hysteresis loops are proposed. These employ the analysis of (i) derivatives of both ascending and descending branches of the loop, (ii) remanent magnetization curves, and (iii) thermomagnetic curves. Computational simulations are used in order to demonstrate their validity. Examples illustrating the applicability of these criteria to well-known real systems, namely Fe_3O_4 and Ni fine particles, are provided. We demonstrate that the anisotropy-field value estimated from a visual examination of an only apparently major hysteresis loop could be more than two times lower than the real one. - Highlights: • Proper estimation of hysteresis-loop parameters is vital in magnetic studies. • We propose criteria for discrimination minor from major hysteresis loops. • The criteria analyze magnetization, remanence and ZFC/FC curves and/or their derivatives. • Examples of their application on real nanoparticles systems are given. • Using the criteria could avoid twofold or bigger saturation-field underestimation errors.

  20. Criteria for saturated magnetization loop

    Harres, A. [Departamento de Física, UFSM, Santa Maria, 97105-900 Rio Grande do Sul (Brazil); Mikhov, M. [Faculty of Physics, University of Sofia, 1164 Sofia (Bulgaria); Skumryev, V. [Institució Catalana de Recerca i Estudis Avançats, 08010 Barcelona (Spain); Departament de Física, Universitat Autònoma de Barcelona, 08193 Barcelona (Spain); Andrade, A.M.H. de; Schmidt, J.E. [Instituto de Física, UFRGS, Porto Alegre, 91501-970 Rio Grande do Sul (Brazil); Geshev, J., E-mail: julian@if.ufrgs.br [Departament de Física, Universitat Autònoma de Barcelona, 08193 Barcelona (Spain); Instituto de Física, UFRGS, Porto Alegre, 91501-970 Rio Grande do Sul (Brazil)

    2016-03-15

    Proper estimation of magnetization curve parameters is vital in studying magnetic systems. In the present article, criteria for discrimination non-saturated (minor) from saturated (major) hysteresis loops are proposed. These employ the analysis of (i) derivatives of both ascending and descending branches of the loop, (ii) remanent magnetization curves, and (iii) thermomagnetic curves. Computational simulations are used in order to demonstrate their validity. Examples illustrating the applicability of these criteria to well-known real systems, namely Fe{sub 3}O{sub 4} and Ni fine particles, are provided. We demonstrate that the anisotropy-field value estimated from a visual examination of an only apparently major hysteresis loop could be more than two times lower than the real one. - Highlights: • Proper estimation of hysteresis-loop parameters is vital in magnetic studies. • We propose criteria for discrimination minor from major hysteresis loops. • The criteria analyze magnetization, remanence and ZFC/FC curves and/or their derivatives. • Examples of their application on real nanoparticles systems are given. • Using the criteria could avoid twofold or bigger saturation-field underestimation errors.

  1. Danish Translation and Linguistic Validation of the U.S. National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

    Bæksted, Christina; Nissen, Aase; Pappot, Helle

    2016-01-01

    CONTEXT: The Common Terminology Criteria for Adverse Events (CTCAE) is the basis for standardized clinician-based grading and reporting of adverse events in cancer clinical trials. The U.S. National Cancer Institute has developed the Patient-Reported Outcomes version of the CTCAE (PRO-CTCAE) to i......CONTEXT: The Common Terminology Criteria for Adverse Events (CTCAE) is the basis for standardized clinician-based grading and reporting of adverse events in cancer clinical trials. The U.S. National Cancer Institute has developed the Patient-Reported Outcomes version of the CTCAE (PRO...

  2. Evaluation Criteria for the Educational Web-Information System

    Seok, Soonhwa; Meyen, Edward; Poggio, John C.; Semon, Sarah; Tillberg-Webb, Heather

    2008-01-01

    This article addresses how evaluation criteria improve educational Web-information system design, and the tangible and intangible benefits of using evaluation criteria, when implemented in an educational Web-information system design. The evaluation criteria were developed by the authors through a content validation study applicable to…

  3. Proposed Diagnostic Criteria for Smartphone Addiction.

    Yu-Hsuan Lin

    Full Text Available Global smartphone penetration has led to unprecedented addictive behaviors. The aims of this study are to develop diagnostic criteria of smartphone addiction and to examine the discriminative ability and the validity of the diagnostic criteria.We developed twelve candidate criteria for characteristic symptoms of smartphone addiction and four criteria for functional impairment caused by excessive smartphone use. The participants consisted of 281 college students. Each participant was systematically assessed for smartphone-using behaviors by psychiatrist's structured diagnostic interview. The sensitivity, specificity, and diagnostic accuracy of the candidate symptom criteria were analyzed with reference to the psychiatrists' clinical global impression. The optimal model selection with its cutoff point of the diagnostic criteria differentiating the smartphone addicted subjects from non-addicted subjects was then determined by the best diagnostic accuracy.Six symptom criteria model with optimal cutoff point were determined based on the maximal diagnostic accuracy. The proposed smartphone addiction diagnostic criteria consisted of (1 six symptom criteria, (2 four functional impairment criteria and (3 exclusion criteria. Setting three symptom criteria as the cutoff point resulted in the highest diagnostic accuracy (84.3%, while the sensitivity and specificity were 79.4% and 87.5%, respectively. We suggested determining the functional impairment by two or more of the four domains considering the high accessibility and penetration of smartphone use.The diagnostic criteria of smartphone addiction demonstrated the core symptoms "impaired control" paralleled with substance related and addictive disorders. The functional impairment involved multiple domains provide a strict standard for clinical assessment.

  4. Prediction value of the Canadian CT head rule and the New Orleans criteria for positive head CT scan and acute neurosurgical procedures in minor head trauma: a multicenter external validation study.

    Bouida, Wahid; Marghli, Soudani; Souissi, Sami; Ksibi, Hichem; Methammem, Mehdi; Haguiga, Habib; Khedher, Sonia; Boubaker, Hamdi; Beltaief, Kaouthar; Grissa, Mohamed Habib; Trimech, Mohamed Naceur; Kerkeni, Wiem; Chebili, Nawfel; Halila, Imen; Rejeb, Imen; Boukef, Riadh; Rekik, Noureddine; Bouhaja, Bechir; Letaief, Mondher; Nouira, Semir

    2013-05-01

    The New Orleans Criteria and the Canadian CT Head Rule have been developed to decrease the number of normal computed tomography (CT) results in mild head injury. We compare the performance of both decision rules for identifying patients with intracranial traumatic lesions and those who require an urgent neurosurgical intervention after mild head injury. This was an observational cohort study performed between 2008 and 2011 on patients with mild head injury who were aged 10 years or older. We collected prospectively clinical head CT scan findings and outcome. Primary outcome was need for neurosurgical intervention, defined as either death or craniotomy, or the need of intubation within 15 days of the traumatic event. Secondary outcome was the presence of traumatic lesions on head CT scan. New Orleans Criteria and Canadian CT Head Rule decision rules were compared by using sensitivity specifications and positive and negative predictive value. We enrolled 1,582 patients. Neurosurgical intervention was performed in 34 patients (2.1%) and positive CT findings were demonstrated in 218 patients (13.8%). Sensitivity and specificity for need for neurosurgical intervention were 100% (95% confidence interval [CI] 90% to 100%) and 60% (95% CI 44% to 76%) for the Canadian CT Head Rule and 82% (95% CI 69% to 95%) and 26% (95% CI 24% to 28%) for the New Orleans Criteria. Negative predictive values for the above-mentioned clinical decision rules were 100% and 99% and positive values were 5% and 2%, respectively, for the Canadian CT Head Rule and New Orleans Criteria. Sensitivity and specificity for clinical significant head CT findings were 95% (95% CI 92% to 98%) and 65% (95% CI 62% to 68%) for the Canadian CT Head Rule and 86% (95% CI 81% to 91%) and 28% (95% CI 26% to 30%) for the New Orleans Criteria. A similar trend of results was found in the subgroup of patients with a Glasgow Coma Scale score of 15. For patients with mild head injury, the Canadian CT Head Rule had higher

  5. Evaluating Dependence Criteria for Caffeine.

    Striley, Catherine L W; Griffiths, Roland R; Cottler, Linda B

    2011-12-01

    Background: Although caffeine is the most widely used mood-altering drug in the world, few studies have operationalized and characterized Diagnostic and Statistical Manual IV (DSM-IV) substance dependence criteria applied to caffeine. Methods: As a part of a nosological study of substance use disorders funded by the National Institute on Drug Abuse, we assessed caffeine use and dependence symptoms among high school and college students, drug treatment patients, and pain clinic patients who reported caffeine use in the last 7 days and also reported use of alcohol, nicotine, or illicit drugs within the past year ( n =167). Results: Thirty-five percent met the criteria for dependence when all seven of the adopted DSM dependence criteria were used. Rates of endorsement of several of the most applicable diagnostic criteria were as follows: 26% withdrawal, 23% desire to cut down or control use, and 44% continued use despite harm. In addition, 34% endorsed craving, 26% said they needed caffeine to function, and 10% indicated that they talked to a physician or counselor about problems experienced with caffeine. There was a trend towards increased caffeine dependence among those dependent on nicotine or alcohol. Within a subgroup that had used caffeine, alcohol, and nicotine in the past year, 28% fulfilled criteria for caffeine dependence compared to 50% for alcohol and 80% for nicotine. Conclusion: The present study adds to a growing literature suggesting the reliability, validity, and clinical utility of the caffeine dependence diagnosis. Recognition of caffeine dependence in the DSM-V may be clinically useful.

  6. Biological Water Quality Criteria

    Page contains links to Technical Documents pertaining to Biological Water Quality Criteria, including, technical assistance documents for states, tribes and territories, program overviews, and case studies.

  7. Clinical validation of the C-VAT 2.0 assessment tool for gaming disorder: a sensitivity analysis of the proposed DSM-5 criteria and the clinical characteristics of young patients with ‘video game addiction’.

    Rooij, A.J. van; Schoenmakers, T.M.; Mheen, D. van de

    2017-01-01

    Aims: Clinicians struggle with the identification of video gaming problems. To address this issue, a clinical assessment tool (C-VAT 2.0) was developed and tested in a clinical setting. The instrument allows exploration of the validity of the DSM-5 proposal for ‘internet gaming disorder’. Method:

  8. Repository operational criteria analysis

    Hageman, J.P.; Chowdhury, A.H.

    1992-08-01

    The objective of the ''Repository Operational Criteria (ROC) Feasibility Studies'' (or ROC task) was to conduct comprehensive and integrated analyses of repository design, construction, and operations criteria in 10 CFR Part 60 regulations, considering the interfaces and impacts of any potential changes to those regulations. The study addresses regulatory criteria related to the preclosure aspects of the geologic repository. The study task developed regulatory concepts or potential repository operational criteria (PROC) based on analysis of a repository's safety functions and other regulations for similar facilities. These regulatory concepts or PROC were used as a basis to assess the sufficiency and adequacy of the current criteria in 10 CFR Part 60. Where the regulatory concepts were same as current operational criteria, these criteria were referenced. The operations criteria referenced or the PROC developed are given in this report. Detailed analyses used to develop the regulatory concepts and any necessary PROC for those regulations that may require a minor change are also presented. The results of the ROC task showed a need for further analysis and possible major rule change related to the design bases of a geologic repository operations area, siting, and radiological emergency planning

  9. CCS site characterisation criteria

    Bachu, S.; Hawkes, C.; Lawton, D.; Pooladi-Darvish, M.; Perkins, E.

    2009-12-15

    IEA GHG recently commissioned the Alberta Research Counil in Canada to conduct a review of storage site selection criteria and site characterisation methods in order to produce a synthesis report. This report reviews the literature on the subject on the site seleciton and characterisation since the publication of the IPCC Special Report on CCS, and provides a synthesis and classification of criteria. 161 refs.

  10. Green Supplier Selection Criteria

    Nielsen, Izabela Ewa; Banaeian, Narges; Golinska, Paulina

    2014-01-01

    Green supplier selection (GSS) criteria arise from an organization inclination to respond to any existing trends in environmental issues related to business management and processes, so GSS is integrating environmental thinking into conventional supplier selection. This research is designed...... to determine prevalent general and environmental supplier selection criteria and develop a framework which can help decision makers to determine and prioritize suitable green supplier selection criteria (general and environmental). In this research we considered several parameters (evaluation objectives......) to establish suitable criteria for GSS such as their production type, requirements, policy and objectives instead of applying common criteria. At first a comprehensive and deep review on prevalent and green supplier selection literatures performed. Then several evaluation objectives defined to assess the green...

  11. Plutonium storage criteria

    Chung, D. [Scientech, Inc., Germantown, MD (United States); Ascanio, X. [Dept. of Energy, Germantown, MD (United States)

    1996-05-01

    The Department of Energy has issued a technical standard for long-term (>50 years) storage and will soon issue a criteria document for interim (<20 years) storage of plutonium materials. The long-term technical standard, {open_quotes}Criteria for Safe Storage of Plutonium Metals and Oxides,{close_quotes} addresses the requirements for storing metals and oxides with greater than 50 wt % plutonium. It calls for a standardized package that meets both off-site transportation requirements, as well as remote handling requirements from future storage facilities. The interim criteria document, {open_quotes}Criteria for Interim Safe Storage of Plutonium-Bearing Solid Materials{close_quotes}, addresses requirements for storing materials with less than 50 wt% plutonium. The interim criteria document assumes the materials will be stored on existing sites, and existing facilities and equipment will be used for repackaging to improve the margin of safety.

  12. What is validation

    Clark, H.K.

    1985-01-01

    Criteria for establishing the validity of a computational method to be used in assessing nuclear criticality safety, as set forth in ''American Standard for Nuclear Criticality Safety in Operations with Fissionable Materials Outside Reactors,'' ANSI/ANS-8.1-1983, are examined and discussed. Application of the criteria is illustrated by describing the procedures followed in deriving subcritical limits that have been incorporated in the Standard

  13. Multimodal freight investment criteria.

    2010-07-01

    Literature was reviewed on multi-modal investment criteria for freight projects, examining measures and techniques for quantifying project benefits and costs, as well as ways to describe the economic importance of freight transportation. : A limited ...

  14. Water Quality Criteria

    EPA develops water quality criteria based on the latest scientific knowledge to protect human health and aquatic life. This information serves as guidance to states and tribes in adopting water quality standards.

  15. Aquatic Life Criteria - Ammonia

    Documents related to EPA's final 2013 Aquatic Life Ambient Water Quality Criteria for Ammonia (Freshwater). These documents pertain to the safe levels of Ammonia in water that should protect to the majority of species.

  16. Aquatic Life Criteria - Copper

    Documents pertain to Aquatic Life Ambient Water Quality criteria for Copper (2007 Freshwater, 2016 Estuarine/marine). These documents contain the safe levels of Copper in water that should protect to the majority of species.

  17. Integrated Criteria Document Chromium

    Slooff W; Cleven RFMJ; Janus JA; van der Poel P; van Beelen P; Boumans LJM; Canton JH; Eerens HC; Krajnc EI; de Leeuw FAAM; Matthijsen AJCM; van de Meent D; van der Meulen A; Mohn GR; Wijland GC; de Bruijn PJ; van Keulen A; Verburgh JJ; van der Woerd KF

    1990-01-01

    Betreft de engelse versie van rapport 758701001
    Bij dit rapport behoort een appendix onder hetzelfde nummer getiteld: "Integrated Criteria Document Chromium: Effects" Auteurs: Janus JA; Krajnc EI
    (appendix: see 710401002A)

  18. Dual Criteria Decisions

    Andersen, Steffen; Harrison, Glenn W.; Lau, Morten Igel

    2014-01-01

    The most popular models of decision making use a single criterion to evaluate projects or lotteries. However, decision makers may actually consider multiple criteria when evaluating projects. We consider a dual criteria model from psychology. This model integrates the familiar tradeoffs between...... to the clear role that income thresholds play in such decision making, but does not rule out a role for tradeoffs between risk and utility or probability weighting....

  19. Rating of environmental criteria

    Glueck, K; Krasser, G

    1980-01-01

    After a general theoretical discussion on the question of rating within a framework of cost-benefit studies, first trials as to the quantification and standardisation of twelve selected environmental criteria by means of an indicator system are worked out and compiled. The selection includes the criteria exhaust gas, dust, micro climate, water pollution, water regime, land requirement, vibrations, traffic noise, landscape scene, urban scene, effect of separation and safety risks. An insight is given of the rating practice using an evaluation of the available literature, of a household interview and of an interview of experts. The interviewing of 156 experts as to their rating conception of ten criteria in the second round has provided contributions to the general problem of the evaluation estimate based on multi criteria analysis as well as differentiation of the twelve or ten environmental criteria. The following criteria ratings given by the experts and which are averaged and smoothed are: traffic noise 20,0% +- 8,5; air pollution 15,0% +- 7,0; safety risk 13,0% +- 7,0; soil and water pollution 8,5% +- 5,0; landscape scene 8,0% +- 4,5; urban scene 8,0% +- 4,5; water regime 6,5% +- 3,5 and vibrations 4,5% +- 2,5.

  20. Testing Standard Reliability Criteria

    Sherry, David

    2017-01-01

    Maul's paper, "Rethinking Traditional Methods of Survey Validation" (Andrew Maul), contains two stages. First he presents empirical results that cast doubt on traditional methods for validating psychological measurement instruments. These results motivate the second stage, a critique of current conceptions of psychological measurement…

  1. Summarized water quality criteria

    Kempster, P.L.; Hattingh, W.H.J.; Van Vliet, H.R.

    1980-08-01

    The available world literature from 27 sources on existing water quality criteria are summarized for the 15 main uses of water. The minimum, median and maximum specified values for 96 different determinands are included. Under each water use the criteria are grouped according to the functional significance of the determinands e.g. aesthetic/physical effects, high toxic potential, low toxic potential etc. A synopsis is included summarizing salient facts for each determinand such as the conditions under which it is toxic and its relationship to other determinands. The significance of the criteria is briefly discussed and the importance of considering functional interactions between determinands emphasized in evaluating the potential for toxic or beneficial effects. From the source literature it appears that the toxic potential, in addition to being determined by concentration, is also affected by the origin of the substance concerned, i.e. whether from natural sources or from anthropogenic pollution

  2. New criteria on the existence of stable-limit cycles

    Gonzales-Gascon, F [Instituto de Estructura de la Materia (GIFT) y Dep. de Fisica Teorica Universidad Complutense, Madrid (Espana); Kumpera, A [Universidade Estadual de Campinas (Brazil). Inst. de Matematica

    1978-06-10

    Negative criteria are given assuring the absence of stable limit cycles. These criteria are valid for vector fields over R/sup 3/ and R/sup 4/ and some of them can be applied to vector fields over Rsup(n).

  3. Radiological design criteria

    Selby, J.M.; Andersen, B.V.; Carter, L.A.; Waite, D.A.

    1977-01-01

    Many new nuclear facilities are unsatisfactory from a radiation protection point of view, particularly when striving to maintain occupational exposure as low as practicable 'ALAP'. Radiation protection is achieved through physical protective features supplemented by administrative controls. Adequate physical protective feature should be achieved during construction so that supplemental administrative controls may be kept simple and workable. Many nuclear facilities fall short of adequate physical protective features, thus, remedial and sometimes awkward administrative procedures are required to safely conduct work. In reviewing the various handbooks, reports and regulations which deal with radiation protection, it may be noted that there is minimal radiological design guidance for application to nuclear facilities. A set of criteria or codes covering functional areas rather than specific nuclear facility types is badly needed. The following are suggested as functional areas to be considered: characterization of the Facility; siting and access; design exposure limits; layout (people and materials flow); ventilation and effluent control; radiation protection facilities and systems. The application of such radiological design criteria early in the design process would provide some assurance that nuclear facilities will be safe, flexible, and efficient with a minimum of costly retrofitting or administrative restrictions. Criteria which we have found helpful in these functional areas is discussed together with justification for adoption of such criteria and identification of problems which still require solution

  4. Comments on confinement criteria

    Kurak, V.; Schroer, B.; Swieca, J.A.

    1977-01-01

    For a QED 2 model with SU(n) flavour, the nature of the physical states space is more subtle than one expects on the basis of the loop criterion for confinement. One may have colour confinement without confinement of the fundamental flavour representation. Attempts to formulate confinement criteria in which the quark fields play a more fundamental role are discussed [pt

  5. Statistical criteria for characterizing irradiance time series.

    Stein, Joshua S.; Ellis, Abraham; Hansen, Clifford W.

    2010-10-01

    We propose and examine several statistical criteria for characterizing time series of solar irradiance. Time series of irradiance are used in analyses that seek to quantify the performance of photovoltaic (PV) power systems over time. Time series of irradiance are either measured or are simulated using models. Simulations of irradiance are often calibrated to or generated from statistics for observed irradiance and simulations are validated by comparing the simulation output to the observed irradiance. Criteria used in this comparison should derive from the context of the analyses in which the simulated irradiance is to be used. We examine three statistics that characterize time series and their use as criteria for comparing time series. We demonstrate these statistics using observed irradiance data recorded in August 2007 in Las Vegas, Nevada, and in June 2009 in Albuquerque, New Mexico.

  6. Squale: evaluation criteria of functioning safety

    Deswarte, Y.; Kaaniche, M.; Benoit, P.

    1998-05-01

    The SQUALE (security, safety and quality evaluation for dependable systems) project is part of the ACTS (advanced communications, technologies and services) European program. Its aim is to develop confidence evaluation criteria to test the functioning safety of systems. All industrial sectors that use critical applications (nuclear, railway, aerospace..) are concerned. SQUALE evaluation criteria differ from the classical evaluation methods: they are independent of the application domains and industrial sectors, they take into account the overall functioning safety attributes, and they can progressively change according to the level of severity required. In order to validate the approach and to refine the criteria, a first experiment is in progress with the METEOR automatic underground railway and another will be carried out on a telecommunication system developed by Bouygues company. (J.S.)

  7. A demonstration of NIOSH push-pull ventilation criteria.

    Klein, M K

    1987-03-01

    This paper summarizes the results of a study performed on an actual chrome plating tank in order to validate criteria for push-pull ventilation systems developed by Huebener and Hughes at NIOSH. Validation of the criteria was made by taking area industrial hygiene samples for hexavalent and total chrome at ten locations around the plating tank. The sampling was performed during actual production runs or while the tank was operating with a dummy load. The sampling data are summarized. The data show that the push-pull system, operating at Huebener's criteria, could control emissions to below the current standards and guidelines. Conclusions and recommendations are included.

  8. Human Systems Design Criteria

    Rasmussen, Jens

    1982-01-01

    This paper deals with the problem of designing more humanised computer systems. This problem can be formally described as the need for defining human design criteria, which — if used in the design process - will secure that the systems designed get the relevant qualities. That is not only...... the necessary functional qualities but also the needed human qualities. The author's main argument is, that the design process should be a dialectical synthesis of the two points of view: Man as a System Component, and System as Man's Environment. Based on a man's presentation of the state of the art a set...... of design criteria is suggested and their relevance discussed. The point is to focus on the operator rather than on the computer. The crucial question is not to program the computer to work on its own conditions, but to “program” the operator to function on human conditions....

  9. Intelligent intefrace design criteria

    Sicard, Y.; Siebert, S.; Thebault, M.H.

    1990-01-01

    Optimum adequation between control means and the capacities of the teams of operators is sought for to achieve computerization of control and monitoring interfaces. Observation of the diagnosis activity of populations of operators in incident situations on a simulator enables design criteria well-suited to the characteristics of the detection, interpretation of symptoms and incident location tasks to be defined. A software tool based on a qualitative approach enables the design process to be systematized

  10. Assessment of Clinical Criteria for Sepsis

    Seymour, Christopher W.; Liu, Vincent X.; Iwashyna, Theodore J.; Brunkhorst, Frank M.; Rea, Thomas D.; Scherag, André; Rubenfeld, Gordon; Kahn, Jeremy M.; Shankar-Hari, Manu; Singer, Mervyn; Deutschman, Clifford S.; Escobar, Gabriel J.; Angus, Derek C.

    2016-01-01

    IMPORTANCE The Third International Consensus Definitions Task Force defined sepsis as “life-threatening organ dysfunction due to a dysregulated host response to infection.” The performance of clinical criteria for this sepsis definition is unknown. OBJECTIVE To evaluate the validity of clinical criteria to identify patients with suspected infection who are at risk of sepsis. DESIGN, SETTINGS, AND POPULATION Among 1.3 million electronic health record encounters from January 1, 2010, to December 31, 2012, at 12 hospitals in southwestern Pennsylvania, we identified those with suspected infection in whom to compare criteria. Confirmatory analyses were performed in 4 data sets of 706 399 out-of-hospital and hospital encounters at 165 US and non-US hospitals ranging from January 1, 2008, until December 31, 2013. EXPOSURES Sequential [Sepsis-related] Organ Failure Assessment (SOFA) score, systemic inflammatory response syndrome (SIRS) criteria, Logistic Organ Dysfunction System (LODS) score, and a new model derived using multivariable logistic regression in a split sample, the quick Sequential [Sepsis-related] Organ Failure Assessment (qSOFA) score (range, 0–3 points, with 1 point each for systolic hypotension [≤100 mm Hg], tachypnea [≥22/min], or altered mentation). MAIN OUTCOMES AND MEASURES For construct validity, pairwise agreement was assessed. For predictive validity, the discrimination for outcomes (primary: in-hospital mortality; secondary: in-hospital mortality or intensive care unit [ICU] length of stay ≥3 days) more common in sepsis than uncomplicated infection was determined. Results were expressed as the fold change in outcome over deciles of baseline risk of death and area under the receiver operating characteristic curve (AUROC). RESULTS In the primary cohort, 148 907 encounters had suspected infection (n = 74 453 derivation; n = 74 454 validation), of whom 6347 (4%) died. Among ICU encounters in the validation cohort (n = 7932 with suspected

  11. Enhanced seismic criteria for piping

    Touboul, F. . E-mail francoise.touboul@cea.fr; Blay, N.; Sollogoub, P.; Chapuliot, S.

    2006-01-01

    In situ or laboratory experiments have shown that piping systems exhibit satisfactory seismic behavior. Seismic motion is not severe enough to significantly damage piping systems unless large differential motions of anchorage are imposed. Nevertheless, present design criteria for piping are very severe and require a large number of supports, which creates overly rigid piping systems. CEA, in collaboration with EDF, FRAMATOME and IRSN, has launched a large R and D program on enhanced design methods which will be less severe, but still conservative, and compatible with defect justification during operation. This paper presents the background of the R and D work on this matter, and CEA proposed equations. Our approach is based on the difference between the real behavior (or the best estimated computed one) with the one supposed by codified methods. Codified criteria are applied on an elastically calculated behavior that can be significantly different from the real one: the effect of plasticity may be very meaningful, even with low incursion in the plastic domain. Moreover, and particularly in piping systems, the elastic follow-up effect affects stress distribution for both seismic and thermal loads. For seismic load, we have proposed to modify the elastic moment limitation, based on the interpretation of experimental results on piping systems. The methods have been validated on more industrial cases, and some of the consequences of the changes have been studied: modification of the drawings and of the number of supports, global displacements, forces in the supports, stability of potential defects, etc. The basic aim of the studies undertaken is to make a decision on the stress classification problem, one that is not limited to seismic induced stresses, and to propose simplified methods for its solution

  12. Criteria for driver impairment

    Brookhuis, K.A.; De Waard, D.; Fairclough, S.H

    2003-01-01

    Most traffic accidents can be attributed to driver impairment, e.g. inattention, fatigue, intoxication, etc. It is now technically feasible to monitor and diagnose driver behaviour with respect to impairment with the aid of a limited number of in-vehicle sensors. However, a valid framework for the

  13. Criteria for software modularization

    Card, David N.; Page, Gerald T.; Mcgarry, Frank E.

    1985-01-01

    A central issue in programming practice involves determining the appropriate size and information content of a software module. This study attempted to determine the effectiveness of two widely used criteria for software modularization, strength and size, in reducing fault rate and development cost. Data from 453 FORTRAN modules developed by professional programmers were analyzed. The results indicated that module strength is a good criterion with respect to fault rate, whereas arbitrary module size limitations inhibit programmer productivity. This analysis is a first step toward defining empirically based standards for software modularization.

  14. Safety and reliability criteria

    O'Neil, R.

    1978-01-01

    Nuclear power plants and, in particular, reactor pressure boundary components have unique reliability requirements, in that usually no significant redundancy is possible, and a single failure can give rise to possible widespread core damage and fission product release. Reliability may be required for availability or safety reasons, but in the case of the pressure boundary and certain other systems safety may dominate. Possible Safety and Reliability (S and R) criteria are proposed which would produce acceptable reactor design. Without some S and R requirement the designer has no way of knowing how far he must go in analysing his system or component, or whether his proposed solution is likely to gain acceptance. The paper shows how reliability targets for given components and systems can be individually considered against the derived S and R criteria at the design and construction stage. Since in the case of nuclear pressure boundary components there is often very little direct experience on which to base reliability studies, relevant non-nuclear experience is examined. (author)

  15. Combining the IADPSG criteria with the WHO diagnostic criteria for ...

    Macrosomia or at least one adverse outcome were more likely in GDM patients who met the diagnostic criteria by both the IADPSG and WHO criteria (P = 0.001). Conclusion: A diagnosis of GDM that meets both the WHO and IADPSG criteria provides stronger prediction for adverse pregnancy outcome than a diagnosis that ...

  16. Nuclear Fuel Safety Criteria Technical Review - Second edition

    Beck, Winfried; Blanpain, Patrick; Fuketa, Toyoshi; Gorzel, Andreas; Hozer, Zoltan; Kamimura, Katsuichiro; Koo, Yang-Hyun; Maertens, Dietmar; Nechaeva, Olga; Petit, Marc; Rehacek, Radomir; Rey-Gayo, Jose Maria; Sairanen, Risto; Sonnenburg, Heinz-Guenther; Valach, Mojmir; Waeckel, Nicolas; Yueh, Ken; Zhang, Jinzhao; Voglewede, John

    2012-01-01

    Most of the current nuclear fuel safety criteria were established during the 1960's and early 1970's. Although these criteria were validated against experiments with fuel designs available at that time, a number of tests were based on unirradiated fuels. Additional verification was performed as these designs evolved, but mostly with the aim of showing that the new designs adequately complied with existing criteria, and not to establish new limits. In 1996, the OECD Nuclear Energy Agency (NEA) reviewed existing fuel safety criteria, focusing on new fuel and core designs, new cladding materials and industry manufacturing processes. The results were published in the Nuclear Fuel Safety Criteria Technical Review of 2001. The NEA has since re-examined the criteria. A brief description of each criterion and its rationale are presented in this second edition, which will be of interest to both regulators and industry (fuel vendors, utilities)

  17. Admission Criteria for MBA Programs

    Silvana Dakduk

    2016-11-01

    Full Text Available This paper reports a review of studies on admission criteria for MBA programs. The method consisted in a literary review based on a systematic search in international databases (Emerald, ABI/INFORM Global, ProQuest Education Journals, ProQuest European Business, ProQuest Science Journal, ProQuest Research Library, ProQuest Psychology Journals, ProQuest Social Science Journals and Business Source Complete of studies published from January 1990 to December 2013, which explore the academic performance of students or graduates of MBA programs. A quantitative review was performed. Results show that most researchers studied relations between GMAT (Graduate Management Admission Test and UGPA (Undergraduate Grade Point Average as predictors of GGPA (Graduate Grade Point Average. On the other hand, work experience and personal traits (such as personality, motivation, learning strategies, self-efficacy beliefs and achievement expectations and their relation with GGPA had been less studied, and results are not consistent enough to consider them valid predictors of student performance at this time.

  18. Animal models of social anxiety disorder and their validity criteria.

    Réus, Gislaine Z; Dos Santos, Maria Augusta B; Abelaira, Helena M; Quevedo, João

    2014-09-26

    Anxiety disorders pose one of the largest threats to global mental health, and they predominantly emerge early in life. Social anxiety disorder, also known as social phobia, is the most common of all anxiety disorders. Moreover, it has severe consequences and is a disabling disorder that can cause an individual to be unable to perform the tasks of daily life. Social anxiety disorder is associated with the subsequent development of major depression and other mental diseases, as well as increased substance abuse. Although some neurobiological alterations have been found to be associated with social anxiety disorder, little is known about this disorder. Animal models are useful tools for the investigation of this disorder, as well as for finding new pharmacological targets for treatment. Thus, this review will highlight the main animal models of anxiety associated with social phobia. Copyright © 2014 Elsevier Inc. All rights reserved.

  19. Laser Safety Inspection Criteria

    Barat, K

    2005-01-01

    A responsibility of the Laser Safety Officer (LSO) is to perform laser safety audits. The American National Standard Z136.1 Safe use of Lasers references this requirement in several sections: (1) Section 1.3.2 LSO Specific Responsibilities states under Hazard Evaluation, ''The LSO shall be responsible for hazards evaluation of laser work areas''; (2) Section 1.3.2.8, Safety Features Audits, ''The LSO shall ensure that the safety features of the laser installation facilities and laser equipment are audited periodically to assure proper operation''; and (3) Appendix D, under Survey and Inspections, it states, ''the LSO will survey by inspection, as considered necessary, all areas where laser equipment is used''. Therefore, for facilities using Class 3B and or Class 4 lasers, audits for laser safety compliance are expected to be conducted. The composition, frequency and rigueur of that inspection/audit rests in the hands of the LSO. A common practice for institutions is to develop laser audit checklists or survey forms. In many institutions, a sole Laser Safety Officer (LSO) or a number of Deputy LSO's perform these audits. For that matter, there are institutions that request users to perform a self-assessment audit. Many items on the common audit list and the associated findings are subjective because they are based on the experience and interest of the LSO or auditor in particular items on the checklist. Beam block usage is an example; to one set of eyes a particular arrangement might be completely adequate, while to another the installation may be inadequate. In order to provide more consistency, the National Ignition Facility Directorate at Lawrence Livermore National Laboratory (NIF-LLNL) has established criteria for a number of items found on the typical laser safety audit form. These criteria are distributed to laser users, and they serve two broad purposes: first, it gives the user an expectation of what will be reviewed by an auditor, and second, it is an

  20. National Recommended Water Quality Criteria

    U.S. Environmental Protection Agency — The National Recommended Water Quality Criteria is a compilation of national recommended water quality criteria for the protection of aquatic life and human health...

  1. Laser Safety Inspection Criteria

    Barat, K.

    2005-01-01

    A responsibility of the Laser Safety Officer (LSO) is to perform laser audits. The American National Standard Z136.1 Safe Use of Lasers references this requirement through several sections. One such reference is Section 1.3.2.8, Safety Features Audits, ''The LSO shall ensure that the safety features of the laser installation facilities and laser equipment are audited periodically to assure proper operation''. The composition, frequency and rigor of that inspection/audit rests in the hands of the LSO. A common practice for institutions is to develop laser audit checklists or survey forms It is common for audit findings from one inspector or inspection to the next to vary even when reviewing the same material. How often has one heard a comment, ''well this area has been inspected several times over the years and no one ever said this or that was a problem before''. A great number of audit items, and therefore findings, are subjective because they are based on the experience and interest of the auditor to particular items on the checklist. Beam block usage, to one set of eyes might be completely adequate, while to another, inadequate. In order to provide consistency, the Laser Safety Office of the National Ignition Facility Directorate has established criteria for a number of items found on the typical laser safety audit form. The criteria are distributed to laser users. It serves two broad purposes; first, it gives the user an expectation of what will be reviewed by an auditor. Second, it is an opportunity to explain audit items to the laser user and thus the reasons for some of these items, such as labelling of beam blocks

  2. Explicating Validity

    Kane, Michael T.

    2016-01-01

    How we choose to use a term depends on what we want to do with it. If "validity" is to be used to support a score interpretation, validation would require an analysis of the plausibility of that interpretation. If validity is to be used to support score uses, validation would require an analysis of the appropriateness of the proposed…

  3. Diagnostic Criteria for Pediatric MS

    J Gordon Millichap

    2013-06-01

    Full Text Available Investigators at Northwestern University Feinberg School of Medicine and Ann & Robert H. Lurie Children’s Hospital of Chicago review the diagnostic criteria for pediatric multiple sclerosis, the differential diagnosis, the 2010 McDonald criteria, and Callen criteria.

  4. A critical overview of safety-related and technological criteria for nuclear fuel

    Lahodova, M.; Valach, M.

    2000-10-01

    A detailed overview of the safety criteria, methods of analysis and computer codes used in OECD countries is presented. A critical analysis of the validity of criteria in the high burnup domain was performed, and recommendations for testing their validity based on available experimental data are put forth. (author)

  5. Exploring PE Teachers' "Gut Feelings": An Attempt to Verbalise and Discuss Teachers' Internalised Grading Criteria

    Svennberg, Lena; Meckbach, Jane; Redelius, Karin

    2014-01-01

    Research shows that teachers' grading is influenced by non-achievement factors in addition to official criteria, such as knowledge and skills. Some grading criteria are internalised by the teacher, who is sometimes unable to verbalise the criteria used and refers to what is called a "gut feeling". Therefore, transparency, validity and…

  6. Decision criteria in PSA applications

    Holmberg, J.E.; Pulkkinen, U.; Rosqvist, T.; Simola, K.

    2001-11-01

    Along with the adoption of risk informed decision making principles, the need for formal probabilistic decision rule or criteria has been risen. However, there are many practical and theoretical problems in the application of probabilistic criteria. One has to think what is the proper way to apply probabilistic rules together with deterministic ones and how the criteria are weighted with respect to each other. In this report, we approach the above questions from the decision theoretic point of view. We give a short review of the most well known probabilistic criteria, and discuss examples of their use. We present a decision analytic framework for evaluating the criteria, and we analyse how the different criteria behave under incompleteness or uncertainty of the PSA model. As the conclusion of our analysis we give recommendations on the application of the criteria in different decision situations. (au)

  7. Continuity between DSM-5 Categorical Criteria and Traits Criteria for Borderline Personality Disorder.

    Bach, Bo; Sellbom, Martin

    2016-08-01

    Borderline personality disorder (BPD) includes a heterogeneous constellation of symptoms operationalized with 9 categorical criteria. As the field of personality disorder (PD) research moves to emphasize dimensional traits in its operationalization, it is important to delineate continuity between the 9 DSM-IV/Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) categorical criteria for BPD and the trait dimensions in DSM-5 Section III. To date, no study has attempted such validation. We examined the associations between the 9 categorical DSM-IV/DSM-5 criteria for BPD and the trait dimensions of the alternative DSM-5 model for PDs in consecutively recruited psychiatric outpatients (N = 142; 68% female; age: mean 29.02, SD 8.38). This was investigated by means of bivariate correlations, followed by multiple logistic regression analysis. The categorical BPD criteria were associated with conceptually related DSM-5 Section III traits (P > 0.001), except for the criterion of chronic feelings of emptiness. Consistent with the proposed traits criteria for BPD in DSM-5 Section III, we found Emotional lability, Anxiousness, Separation insecurity, Depressivity, Impulsivity, Risk taking, and Hostility to capture conceptually coherent BPD categorical criteria, while Suspiciousness was also strongly associated with BPD criteria. At the domain level, this applied to Negative affectivity, Disinhibition, and Psychoticism. Notably, Emotional lability, Impulsivity, and Suspiciousness emerged as unique predictors of BPD (P > 0.05). In addition to the proposed BPD traits criteria, Suspiciousness and features of Psychoticism also augment BPD features. Provided that these findings are replicated in forthcoming research, a modified traits operationalization of BPD is warranted. © The Author(s) 2016.

  8. Defining active sacroiliitis on magnetic resonance imaging (MRI) for classification of axial spondyloarthritis: a consensual approach by the ASAS/OMERACT MRI group

    Rudwaleit, M; Jurik, A G; Hermann, K-G A

    2009-01-01

    BACKGROUND: Magnetic resonance imaging (MRI) of sacroiliac joints has evolved as the most relevant imaging modality for diagnosis and classification of early axial spondyloarthritis (SpA) including early ankylosing spondylitis. OBJECTIVES: To identify and describe MRI findings in sacroiliitis and...... relevant for sacroiliitis have been defined by consensus by a group of rheumatologists and radiologists. These definitions should help in applying correctly the imaging feature "active sacroiliitis by MRI" in the new ASAS classification criteria for axial SpA.......BACKGROUND: Magnetic resonance imaging (MRI) of sacroiliac joints has evolved as the most relevant imaging modality for diagnosis and classification of early axial spondyloarthritis (SpA) including early ankylosing spondylitis. OBJECTIVES: To identify and describe MRI findings in sacroiliitis...... conditions which may mimic SpA. Descriptions of the pathological findings and technical requirements for the appropriate acquisition were formulated. In a consensual approach MRI findings considered to be essential for sacroiliitis were defined. RESULTS: Active inflammatory lesions such as bone marrow oedema...

  9. STOPP/START criteria for potentially inappropriate prescribing in older people: version 2.

    O'Mahony, Denis; O'Sullivan, David; Byrne, Stephen; O'Connor, Marie Noelle; Ryan, Cristin; Gallagher, Paul

    2015-03-01

    Screening tool of older people's prescriptions (STOPP) and screening tool to alert to right treatment (START) criteria were first published in 2008. Due to an expanding therapeutics evidence base, updating of the criteria was required. We reviewed the 2008 STOPP/START criteria to add new evidence-based criteria and remove any obsolete criteria. A thorough literature review was performed to reassess the evidence base of the 2008 criteria and the proposed new criteria. Nineteen experts from 13 European countries reviewed a new draft of STOPP & START criteria including proposed new criteria. These experts were also asked to propose additional criteria they considered important to include in the revised STOPP & START criteria and to highlight any criteria from the 2008 list they considered less important or lacking an evidence base. The revised list of criteria was then validated using the Delphi consensus methodology. The expert panel agreed a final list of 114 criteria after two Delphi validation rounds, i.e. 80 STOPP criteria and 34 START criteria. This represents an overall 31% increase in STOPP/START criteria compared with version 1. Several new STOPP categories were created in version 2, namely antiplatelet/anticoagulant drugs, drugs affecting, or affected by, renal function and drugs that increase anticholinergic burden; new START categories include urogenital system drugs, analgesics and vaccines. STOPP/START version 2 criteria have been expanded and updated for the purpose of minimizing inappropriate prescribing in older people. These criteria are based on an up-to-date literature review and consensus validation among a European panel of experts. © The Author 2014. Published by Oxford University Press on behalf of the British Geriatrics Society.

  10. ACR appropriateness criteria jaundice.

    Lalani, Tasneem; Couto, Corey A; Rosen, Max P; Baker, Mark E; Blake, Michael A; Cash, Brooks D; Fidler, Jeff L; Greene, Frederick L; Hindman, Nicole M; Katz, Douglas S; Kaur, Harmeet; Miller, Frank H; Qayyum, Aliya; Small, William C; Sudakoff, Gary S; Yaghmai, Vahid; Yarmish, Gail M; Yee, Judy

    2013-06-01

    A fundamental consideration in the workup of a jaundiced patient is the pretest probability of mechanical obstruction. Ultrasound is the first-line modality to exclude biliary tract obstruction. When mechanical obstruction is present, additional imaging with CT or MRI can clarify etiology, define level of obstruction, stage disease, and guide intervention. When mechanical obstruction is absent, additional imaging can evaluate liver parenchyma for fat and iron deposition and help direct biopsy in cases where underlying parenchymal disease or mass is found. Imaging techniques are reviewed for the following clinical scenarios: (1) the patient with painful jaundice, (2) the patient with painless jaundice, and (3) the patient with a nonmechanical cause for jaundice. The ACR Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed every 2 years by a multidisciplinary expert panel. The guideline development and review include an extensive analysis of current medical literature from peer-reviewed journals and the application of a well-established consensus methodology (modified Delphi) to rate the appropriateness of imaging and treatment procedures by the panel. In those instances where evidence is lacking or not definitive, expert opinion may be used to recommend imaging or treatment. Copyright © 2013 American College of Radiology. Published by Elsevier Inc. All rights reserved.

  11. Criteria of site assessment

    Gibbs, P.; Fuchs, H.

    1975-01-01

    The criteria which lead to the choice of a particular site for a nuclear power station are in general very similar to those which would apply to any other type of power station. The principal differences derive from the simpler transport problems for the fuel compared with, say, solid fuel and the special safety considerations which attach to nuclear reactors. The search for a suitable site obviously starts by considering where the power is needed, i.e. where the load centers are and also the existing transmission network which may help to bring the power from a more remote site to the load centers. This economic incentive to put the plant close to loads conflicts directly with the nuclear safety argument which favours more remote siting, and part of the problem of site selection is to reconcile these two matters. In addition, there are many other important matters which will be considered later concerning the adequacy of cooling water supplies, foundation conditions, etc., all of which must be examined in considerable detail. (orig./TK) [de

  12. Criteria for decommissioning

    Ricci, P.F.

    1988-01-01

    In this paper the authors describe three risk acceptability criteria as parts of a strategy to clean up decommissioned facilities, related to both the status quo and to a variety of alternative technical clean-up options. The acceptability of risk is a consideration that must enter into any decision to establish when a site is properly decommissioned. To do so, both the corporate and public aspects of the acceptability issue must be considered. The reasons for discussion the acceptability of risk are to: Legitimize the process for making cleanup decisions; Determine who is at risk, who benefits, and who bears the costs of site cleanup, for each specific cleanup option, including the do nothing option; Establish those factors that, taken as a whole, determine measures of acceptability; Determine chemical-specific aggregate and individual risk levels; and Establish levels for cleanup. The choice of these reasons is pragmatic. The method consistent with these factors is risk-risk-effectiveness: the level of cleanup must be consistent with the foreseeable use of the site and budget constraints. Natural background contamination is the level below which further cleanup is generally inefficient. Case-by-case departures from natural background are to be considered depending on demonstrated risk. For example, a hot spot is obviously a prima facie exception, but should be rebuttable. Rebuttability means that, through consensus, the ''hot spot'' is shown not to be associated with exposure

  13. Criteria for performance evaluation

    David J. Weiss

    2009-03-01

    Full Text Available Using a cognitive task (mental calculation and a perceptual-motor task (stylized golf putting, we examined differential proficiency using the CWS index and several other quantitative measures of performance. The CWS index (Weiss and Shanteau, 2003 is a coherence criterion that looks only at internal properties of the data without incorporating an external standard. In Experiment 1, college students (n = 20 carried out 2- and 3-digit addition and multiplication problems under time pressure. In Experiment 2, experienced golfers (n = 12, also college students, putted toward a target from nine different locations. Within each experiment, we analyzed the same responses using different methods. For the arithmetic tasks, accuracy information (mean absolute deviation from the correct answer, MAD using a coherence criterion was available; for golf, accuracy information using a correspondence criterion (mean deviation from the target, also MAD was available. We ranked the performances of the participants according to each measure, then compared the orders using Spearman's rextsubscript{s}. For mental calculation, the CWS order correlated moderately (rextsubscript{s} =.46 with that of MAD. However, a different coherence criterion, degree of model fit, did not correlate with either CWS or accuracy. For putting, the ranking generated by CWS correlated .68 with that generated by MAD. Consensual answers were also available for both experiments, and the rankings they generated correlated highly with those of MAD. The coherence vs. correspondence distinction did not map well onto criteria for performance evaluation.

  14. FHR Generic Design Criteria

    Flanagan, George F [ORNL; Holcomb, David Eugene [ORNL; Cetiner, Sacit M [ORNL

    2012-06-01

    The purpose of this document is to provide an initial, focused reference to the safety characteristics of and a licensing approach for Fluoride-Salt-Cooled High-Temperature Reactors (FHRs). The document does not contain details of particular reactor designs nor does it attempt to identify or classify either design basis or beyond design basis accidents. Further, this document is an initial attempt by a small set of subject matter experts to document the safety and licensing characteristics of FHRs for a larger audience. The document is intended to help in setting the safety and licensing research, development, and demonstration path forward. Input from a wider audience, further technical developments, and additional study will be required to develop a consensus position on the safety and licensing characteristics of FHRs. This document begins with a brief overview of the attributes of FHRs and then a general description of their anticipated safety performance. Following this, an overview of the US nuclear power plant approval process is provided that includes both test and power reactors, as well as the role of safety standards in the approval process. The document next describes a General Design Criteria (GDC) - based approach to licensing an FHR and provides an initial draft set of FHR GDCs. The document concludes with a description of a path forward toward developing an FHR safety standard that can support both a test and power reactor licensing process.

  15. Validação de critérios para controle de perdas de vitamina C em hortaliças preparadas em unidade de alimentação e nutrição hospitalar Validation of criteria to control loss of vitamin C in vegetables prepared in a hospital food service unity

    Ceres Mattos Della Lucia

    2008-12-01

    Full Text Available Este estudo teve como objetivo validar critérios testados em laboratório, visando à preservação de vitamina C (Ácido Ascórbico (AA e Ácido Desidroascórbico (DHA em couve e tomate preparados em Unidade de Alimentação e Nutrição (UAN hospitalar. Os critérios foram: armazenamento por 24 horas sob refrigeração (10 °C, sanitização por 15 minutos e distribuição logo após o preparo. Avaliou-se também o conteúdo e a retenção de vitamina C após diferentes tempos de exposição para consumo, rotineiramente utilizados pela UAN. As análises foram realizadas por Cromatografia Líquida de Alta Eficiência (CLAE, utilizando como fase móvel fosfato de sódio 1 mM, EDTA 1mM, diluídos em água ultrapura, pH 3,0 ajustado com ácido fosfórico. A ANOVA (α = 0,05 foi utilizada para análise dos dados. Não houve diferenças significativas quanto ao conteúdo de vitamina C após as etapas de manipulação das hortaliças, confirmando alta estabilidade da vitamina quanto aos critérios adotados. Entretanto, observou-se redução da retenção de AA em couve aos 60 minutos de exposição para consumo (retenção: 46,94% e em tomate aos 120 minutos de exposição (retenção: 71,81%. Os critérios mostraram-se eficientes no controle de perdas de vitamina C, recomendando-se sua adoção em outras UAN.This study aimed to validate laboratory tested criteria to preserve vitamin C (Ascorbic Acid (AA and Dehydroascorbic Acid (DHA in collard and tomato prepared in a Hospital Food Service (HFS. The criteria were: 24 hour-storage under refrigeration (10 °C, cleansing for 15 minutes, and distribution right after preparation. The consume exposure times, frequently used by the HFS, were also analyzed. High Performance Liquid Chromatography (HPLC was the analysis method employed, using as mobile phase sodium phosphate 1 mM, EDTA 1 mM, all diluted in ultra pure water, and pH 3.0 adjusted with phosphoric acid. ANOVA (α = 0.05 was used to data analysis

  16. New Myositis Classification Criteria-What We Have Learned Since Bohan and Peter.

    Leclair, Valérie; Lundberg, Ingrid E

    2018-03-17

    Idiopathic inflammatory myopathy (IIM) classification criteria have been a subject of debate for many decades. Despite several limitations, the Bohan and Peter criteria are still widely used. The aim of this review is to discuss the evolution of IIM classification criteria. New IIM classification criteria are periodically proposed. The discovery of myositis-specific and myositis-associated autoantibodies led to the development of clinico-serological criteria, while in-depth description of IIM morphological features improved histopathology-based criteria. The long-awaited European League Against Rheumatism and American College of Rheumatology (EULAR/ACR) IIM classification criteria were recently published. The Bohan and Peter criteria are outdated and validated classification criteria are necessary to improve research in IIM. The new EULAR/ACR IIM classification criteria are thus a definite improvement and an important step forward in the field.

  17. Gout Classification Criteria: Update and Implications

    Vargas-Santos, Ana Beatriz; Taylor, William J.

    2016-01-01

    Gout is the most common inflammatory arthritis, with a rising prevalence and incidence worldwide. There has been a resurgence in gout research, fueled, in part, by a number of advances in pharmacologic therapy for gout. The conduct of clinical trials and other observational research in gout requires a standardized and validated means of assembling well-defined groups of patients with gout for such research purposes. Recently, an international collaborative effort that involved a data-driven process with state-of-the art methodology supported by the American College of Rheumatology and the European League Against Rheumatism led to publication of new gout classification criteria. PMID:27342957

  18. Water quality criteria for lead

    Nagpal, N.K.

    1987-01-01

    This report is one in a series that establishes water quality criteria for British Columbia. The report sets criteria for lead to protect a number of water uses, including drinking water, freshwater and marine aquatic life, wildlife, livestock, irrigation, and recreation. The criteria are set as either maximum concentrations of total lead that should not be exceeded at any time, or average concentrations that should not be exceeded over a 30-day period. Actual values are summarized.

  19. Criteria for Authorship in Bioethics

    Resnik, David B.; Master, Zubin

    2011-01-01

    Multiple authorship is becoming increasingly common in bioethics research. There are well-established criteria for authorship in empirical bioethics research but not for conceptual research. It is important to develop criteria for authorship in conceptual publications to prevent undeserved authorship and uphold standards of fairness and accountability. This article explores the issue of multiple authorship in bioethics and develops criteria for determining who should be an author on a concept...

  20. Combining the IADPSG criteria with the WHO diagnostic criteria for ...

    The International Association of Diabetes in Pregnancy Study Group (IADPSG) and World Health ... Macrosomia or at least one adverse outcome were more likely in GDM patients who ... criteria for GDM in the ADA's more recent position statement.[18] .... at risk for postpartum type 2 DM;[27] the IADPSG criteria on the other ...

  1. Sediment quality criteria: A review with recommendations for developing criteria for the Hanford Site

    Driver, C.J.

    1994-05-01

    Criteria for determining the quality of liver sediment are necessary to ensure that concentrations of contaminants in aquatic systems are within acceptable limits for the protection of aquatic and human life. Such criteria should facilitate decision-making about remediation, handling, and disposal of contaminants. Several approaches to the development of sediment quality criteria (SQC) have been described and include both descriptive and numerical methods. However, no single method measures all impacts at all times to all organisms (U.S. EPA 1992b). The U.S. EPA`s interest is primarily in establishing chemically based, numerical SQC that are applicable nation-wide (Shea 1988). Of the approaches proposed for SQC development, only three are being considered for numerical SQC on a national level. These approaches include an Equilibrium Partitioning Approach, a site-specific method using bioassays (the Apparent Effects Threshold Approach), and an approach similar to EPA`s water quality criteria (Pavlou and Weston 1984). Although national (or even regional) criteria address a number of political, litigative, and engineering needs, some researchers feel that protection of benthic communities require site-specific, biologically based criteria (Baudo et al. 1990). This is particularly true for areas where complex mixtures of contaminants are present in sediments. Other scientifically valid and accepted procedures for freshwater SQC include a background concentration approach, methods using field or spiked bioassays, a screening level concentration approach, the Apparent Effects Threshold Approach, the Sediment Quality Triad, the International Joint Commission Sediment Assessment Strategy, and the National Status and Trends Program Approach. The various sediment assessment approaches are evaluated for application to the Hanford Reach and recommendations for Hanford Site sediment quality criteria are discussed.

  2. CFD validation experiments for hypersonic flows

    Marvin, Joseph G.

    1992-01-01

    A roadmap for CFD code validation is introduced. The elements of the roadmap are consistent with air-breathing vehicle design requirements and related to the important flow path components: forebody, inlet, combustor, and nozzle. Building block and benchmark validation experiments are identified along with their test conditions and measurements. Based on an evaluation criteria, recommendations for an initial CFD validation data base are given and gaps identified where future experiments could provide new validation data.

  3. A CFD validation roadmap for hypersonic flows

    Marvin, Joseph G.

    1993-01-01

    A roadmap for computational fluid dynamics (CFD) code validation is developed. The elements of the roadmap are consistent with air-breathing vehicle design requirements and related to the important flow path components: forebody, inlet, combustor, and nozzle. Building block and benchmark validation experiments are identified along with their test conditions and measurements. Based on an evaluation criteria, recommendations for an initial CFD validation data base are given and gaps identified where future experiments would provide the needed validation data.

  4. Principles and Criteria for Design

    Beghin, D.; Cervetto, D.; Hansen, Peter Friis

    1997-01-01

    The mandate of ISSC Committee IV.1 on principles and Criteria for Design is to report on the following:The ongoing concern for quantification of general economic and safety criteria for marine structures and for the development of appropriate principles for rational life cycle design using...

  5. Diagnostic criteria for vascular dementia

    Scheltens, P.; Hijdra, A. H.

    1998-01-01

    The term vascular dementia implies the presence of a clinical syndrome (dementia) caused by, or at least assumed to be caused by, a specific disorder (cerebrovascular disease). In this review, the various sets of criteria used to define vascular dementia are outlined. The various sets of criteria

  6. Criteria for controlled atmosphere chambers

    Robinson, J.N.

    1980-03-01

    The criteria for design, construction, and operation of controlled atmosphere chambers intended for service at ORNL are presented. Classification of chambers, materials for construction, design criteria, design, controlled atmosphere chamber systems, and operating procedures are presented. ORNL Safety Manual Procedure 2.1; ORNL Health Physics Procedure Manual Appendix A-7; and Design of Viewing Windows are included in 3 appendices

  7. Failure Criteria for Reinforced Materials

    Rathkjen, Arne

    Failure of materials is often characterized as ductile yielding, brittle fracture, creep rupture, etc., and different criteria given in terms of different parameters have been used to describe different types of failure. Only criteria expressing failure in terms of stress are considered in what...... place until the matrix, the continuous component of the composite, fails. When an isotropic matrix is reinforced as described above, the result is an anisotropic composite material. Even if the material is anisotropic, it usually exhibits a rather high degree of symmetry and such symmetries place...... certain restrictions on the form of the failure criteria for anisotropic materials. In section 2, some failure criteria for homogenous materials are reviewed. Both isotropic and anisotropic materials are described, and in particular the constraints imposed on the criteria from the symmetries orthotropy...

  8. Verification and validation for waste disposal models

    1987-07-01

    A set of evaluation criteria has been developed to assess the suitability of current verification and validation techniques for waste disposal methods. A survey of current practices and techniques was undertaken and evaluated using these criteria with the items most relevant to waste disposal models being identified. Recommendations regarding the most suitable verification and validation practices for nuclear waste disposal modelling software have been made

  9. Idaho National Engineering Laboratory release criteria for decontamination and decommissioning

    Dolenc, M.R.; Case, M.J.

    1986-01-01

    Criteria have been developed for release of Idaho National Engineering Laboratory (INEL) facilities and land areas following decontamination and decommissioning (D and D). Decommissioning release criteria in the form of dose guidelines were proposed by the US Nuclear Regulatory Commission as early as 1980. These criteria were used on an interim basis for INEL D and D projects. However, dose guidelines alone do not adequately cover the criteria necessary to release sites for unrestricted use. In actual practice, other parameters such as pathways analyses, sampling and instrumentation techniques, and implementation procedures are required to develop the basis for unrestricted release of a site. Thus, a rigorous approach for evaluating these other parameters is needed to develop acceptable D and D release criteria. Because of the complex and sensitive nature of the dose and pathways analyses work, a thorough review by experts in those respective fields was desired. Input and support in preparing or reviewing each part of the criteria development task was solicited from several DOE field offices. Experts were identified and contracted to assist in preparing portions of the release criteria, or to serve on a peer-review committee. Thus, the entire release criteria development task was thoroughly reviewed by recognized experts from each DOE field office, to validate technical content of the INEL site-specific document

  10. FACTAR validation

    Middleton, P.B.; Wadsworth, S.L.; Rock, R.C.; Sills, H.E.; Langman, V.J.

    1995-01-01

    A detailed strategy to validate fuel channel thermal mechanical behaviour codes for use of current power reactor safety analysis is presented. The strategy is derived from a validation process that has been recently adopted industry wide. Focus of the discussion is on the validation plan for a code, FACTAR, for application in assessing fuel channel integrity safety concerns during a large break loss of coolant accident (LOCA). (author)

  11. The measurement of instrumental ADL: content validity and construct validity

    Avlund, K; Schultz-Larsen, K; Kreiner, S

    1993-01-01

    do not depend on help. It is also possible to add the items in a valid way. However, to obtain valid IADL-scales, we omitted items that were highly relevant to especially elderly women, such as house-work items. We conclude that the criteria employed for this IADL-measure are somewhat contradictory....... showed that 14 items could be combined into two qualitatively different additive scales. The IADL-measure complies with demands for content validity, distinguishes between what the elderly actually do, and what they are capable of doing, and is a good discriminator among the group of elderly persons who...

  12. Analysing and Comparing Encodability Criteria

    Kirstin Peters

    2015-08-01

    Full Text Available Encodings or the proof of their absence are the main way to compare process calculi. To analyse the quality of encodings and to rule out trivial or meaningless encodings, they are augmented with quality criteria. There exists a bunch of different criteria and different variants of criteria in order to reason in different settings. This leads to incomparable results. Moreover it is not always clear whether the criteria used to obtain a result in a particular setting do indeed fit to this setting. We show how to formally reason about and compare encodability criteria by mapping them on requirements on a relation between source and target terms that is induced by the encoding function. In particular we analyse the common criteria full abstraction, operational correspondence, divergence reflection, success sensitiveness, and respect of barbs; e.g. we analyse the exact nature of the simulation relation (coupled simulation versus bisimulation that is induced by different variants of operational correspondence. This way we reduce the problem of analysing or comparing encodability criteria to the better understood problem of comparing relations on processes.

  13. Evaluation Criteria and Indicators of Quality for Internet Resources.

    Wilkinson, Gene L.; And Others

    1997-01-01

    Most Web site rating systems overemphasize technological "bells and whistles." The University of Georgia's information quality criteria address site access and usability; resource identification and documentation; author identification; authority of author; information structure and design; relevance and scope, validity, and accuracy and…

  14. Toward a Unified Validation Framework in Mixed Methods Research

    Dellinger, Amy B.; Leech, Nancy L.

    2007-01-01

    The primary purpose of this article is to further discussions of validity in mixed methods research by introducing a validation framework to guide thinking about validity in this area. To justify the use of this framework, the authors discuss traditional terminology and validity criteria for quantitative and qualitative research, as well as…

  15. Aquatic Life Criteria - Tributyltin (TBT)

    Documents pertaining to 2004 Final Acute and Chronic Ambient Aquatic Life Water Quality Criteria for Tributyltin (TBT) for freshwater and saltwater. These documents include the safe levels of TBT that should protect the majority of species.

  16. Floorball game skills (evaluation criteria)

    Chlumský, Marek

    2013-01-01

    Title: Playing skills in floorball (evaluation criteria). Target: To create a list of playing skills which an ideal player should demonstrate. Find and verify the evaluation criteria of these skills and inspire trainers to develop these skills in the best way. Methods: Informal interviews, individually structured interviews, analysis and verification of data, pilot testing. Results: Defined playing skills in floorball, developed scale of values of floorball playing skills, creation of exercis...

  17. Reliability criteria for voltage stability

    Taylor, Carson W; Silverstein, Brian L [Bonneville Power Administration, Portland, OR (United States)

    1994-12-31

    In face of costs pressures, there is need to allocate scare resources more effectively in order to achieve voltage stability. This naturally leads to development of probabilistic criteria and notions of rick management. In this paper it is presented a discussion about criteria for long term voltage stability limited to the case in which the time frames are topically several minutes. (author) 14 refs., 1 fig.

  18. Toxic chemical risk acceptance criteria

    Craig, D.K.; Davis, J.; Lee, L.; Lein, P.; Omberg, S.

    1992-01-01

    This paper presents recommendations of a subcommittee of the Westinghouse M ampersand 0 Nuclear Facility Safety Committee concerning toxic chemical risk acceptance criteria. Two sets of criteria have been developed, one for use in the hazard classification of facilities, and the second for use in comparing risks in DOE non-reactor nuclear facility Safety Analysis Reports. The Emergency Response Planning Guideline (ERPG) values are intended to provide estimates of concentration ranges for specific chemicals above which exposure would be expected to lead to adverse heath effects of increasing severity for ERPG-1, -2, and -3s. The subcommittee recommends that criteria for hazard class or risk range be based on ERPGs for all chemicals. Probability-based Incremental Cancer Risk (ICR) criteria are recommended for additional analyses of risks from all known or suspected human carcinogens. Criteria are given for both on-site and off-site exposure. The subcommittee also recommends that the 5-minute peak concentration be compared with the relevant criterion with no adjustment for exposure time. Since ERPGs are available for only a limited number of chemicals, the subcommittee has developed a proposed hierarchy of concentration limit parameters for the different criteria

  19. Validation of a rubric to assess innovation competence

    Frances Watts

    2012-06-01

    Full Text Available This paper addresses the development and validation of rubrics, materials and situations for the assessment of innovation competence. Research was carried out to verify the viability of the first draft of the assessment criteria, which led to refinement of the criteria and proposals to enhance the ensuing validation process that will include students and raters of different language backgrounds.

  20. Evaluation and construction of diagnostic criteria for inclusion body myositis

    Mammen, Andrew L.; Amato, Anthony A.; Weiss, Michael D.; Needham, Merrilee

    2014-01-01

    Objective: To use patient data to evaluate and construct diagnostic criteria for inclusion body myositis (IBM), a progressive disease of skeletal muscle. Methods: The literature was reviewed to identify all previously proposed IBM diagnostic criteria. These criteria were applied through medical records review to 200 patients diagnosed as having IBM and 171 patients diagnosed as having a muscle disease other than IBM by neuromuscular specialists at 2 institutions, and to a validating set of 66 additional patients with IBM from 2 other institutions. Machine learning techniques were used for unbiased construction of diagnostic criteria. Results: Twenty-four previously proposed IBM diagnostic categories were identified. Twelve categories all performed with high (≥97%) specificity but varied substantially in their sensitivities (11%–84%). The best performing category was European Neuromuscular Centre 2013 probable (sensitivity of 84%). Specialized pathologic features and newly introduced strength criteria (comparative knee extension/hip flexion strength) performed poorly. Unbiased data-directed analysis of 20 features in 371 patients resulted in construction of higher-performing data-derived diagnostic criteria (90% sensitivity and 96% specificity). Conclusions: Published expert consensus–derived IBM diagnostic categories have uniformly high specificity but wide-ranging sensitivities. High-performing IBM diagnostic category criteria can be developed directly from principled unbiased analysis of patient data. Classification of evidence: This study provides Class II evidence that published expert consensus–derived IBM diagnostic categories accurately distinguish IBM from other muscle disease with high specificity but wide-ranging sensitivities. PMID:24975859

  1. A proposal of criteria for the classification of systemic sclerosis.

    Nadashkevich, Oleg; Davis, Paul; Fritzler, Marvin J

    2004-11-01

    Sensitive and specific criteria for the classification of systemic sclerosis are required by clinicians and investigators to achieve higher quality clinical studies and approaches to therapy. A clinical study of systemic sclerosis patients in Europe and Canada led to a set of criteria that achieve high sensitivity and specificity. Both clinical and laboratory investigations of patients with systemic sclerosis, related conditions and diseases with clinical features that can be mistaken as part of the systemic sclerosis spectrum were undertaken. Laboratory investigations included the detection of autoantibodies to centromere proteins, Scl-70 (topoisomerase I), and fibrillarin (U3-RNP). Based on the investigation of 269 systemic sclerosis patients and 720 patients presenting with related and confounding conditions, the following set of criteria for the classification of systemic sclerosis was proposed: 1) autoantibodies to: centromere proteins, Scl-70 (topo I), fibrillarin; 2) bibasilar pulmonary fibrosis; 3) contractures of the digital joints or prayer sign; 4) dermal thickening proximal to the wrists; 5) calcinosis cutis; 6) Raynaud's phenomenon; 7) esophageal distal hypomotility or reflux-esophagitis; 8) sclerodactyly or non-pitting digital edema; 9) teleangiectasias. The classification of definite SSc requires at least three of the above criteria. Criteria for the classification of systemic sclerosis have been proposed. Preliminary testing has defined the sensitivity and specificity of these criteria as high as 99% and 100%, respectively. Testing and validation of the proposed criteria by other clinical centers is required.

  2. Validity in assessment of prior learning

    Wahlgren, Bjarne; Aarkrog, Vibe

    2015-01-01

    , the article discusses the need for specific criteria for assessment. The reliability and validity of the assessment procedures depend on whether the competences are well-defined, and whether the teachers are adequately trained for the assessment procedures. Keywords: assessment, prior learning, adult...... education, vocational training, lifelong learning, validity...

  3. Social Advertising Quality: Assessment Criteria

    S. B. Kalmykov

    2017-01-01

    Full Text Available Purpose: the The purpose of the publication is development of existing criterial assessment in social advertising sphere. The next objectives are provided for its achievement: to establish research methodology, to develop the author’s version of necessary notional apparatus and conceptual generalization, to determine the elements of social advertising quality, to establish the factors of its quality, to conduct the systematization of existing criteria and measuring instruments of quality assessment, to form new criteria of social advertising quality, to apply received results for development of criterial assessment to determine the further research perspectives. Methods: the methodology of research of management of social advertising interaction with target audience, which has dynamic procedural character with use of sociological knowledge multivariate paradigmatic status, has been proposed. Results: the primary received results: the multivariate paradigmatic research basis with use of works of famous domestic and foreign scientists in sociology, qualimetry and management spheres; the definitions of social advertising, its quality, sociological quality provision system, target audience behavior model during social advertising interaction are offered; the quality factors with three groups by level of effect on consumer are established; the systematization of existing quality and its measure instruments assessment criteria by detected social advertising quality elements are conducted; the two new criteria and its management quality assessment measuring instruments in social advertising sphere are developed; the one of the common groups of production quality criteria – adaptability with considering of new management quality criteria and conducted systematization of existing social advertising creative quality assessment criteria development; the perspective of further perfection of quality criterial assessment based on social advertising

  4. Musculoskeletal ultrasound including definitions for ultrasonographic pathology

    Wakefield, RJ; Balint, PV; Szkudlarek, Marcin

    2005-01-01

    Ultrasound (US) has great potential as an outcome in rheumatoid arthritis trials for detecting bone erosions, synovitis, tendon disease, and enthesopathy. It has a number of distinct advantages over magnetic resonance imaging, including good patient tolerability and ability to scan multiple joints...... in a short period of time. However, there are scarce data regarding its validity, reproducibility, and responsiveness to change, making interpretation and comparison of studies difficult. In particular, there are limited data describing standardized scanning methodology and standardized definitions of US...... pathologies. This article presents the first report from the OMERACT ultrasound special interest group, which has compared US against the criteria of the OMERACT filter. Also proposed for the first time are consensus US definitions for common pathological lesions seen in patients with inflammatory arthritis....

  5. Reliability Criteria for Thick Bonding Wire.

    Dagdelen, Turker; Abdel-Rahman, Eihab; Yavuz, Mustafa

    2018-04-17

    Bonding wire is one of the main interconnection techniques. Thick bonding wire is widely used in power modules and other high power applications. This study examined the case for extending the use of traditional thin wire reliability criteria, namely wire flexure and aspect ratio, to thick wires. Eleven aluminum (Al) and aluminum coated copper (CucorAl) wire samples with diameter 300 μm were tested experimentally. The wire response was measured using a novel non-contact method. High fidelity FEM models of the wire were developed and validated. We found that wire flexure is not correlated to its stress state or fatigue life. On the other hand, aspect ratio is a consistent criterion of thick wire fatigue life. Increasing the wire aspect ratio lowers its critical stress and increases its fatigue life. Moreover, we found that CucorAl wire has superior performance and longer fatigue life than Al wire.

  6. Reliability Criteria for Thick Bonding Wire

    Turker Dagdelen

    2018-04-01

    Full Text Available Bonding wire is one of the main interconnection techniques. Thick bonding wire is widely used in power modules and other high power applications. This study examined the case for extending the use of traditional thin wire reliability criteria, namely wire flexure and aspect ratio, to thick wires. Eleven aluminum (Al and aluminum coated copper (CucorAl wire samples with diameter 300 μm were tested experimentally. The wire response was measured using a novel non-contact method. High fidelity FEM models of the wire were developed and validated. We found that wire flexure is not correlated to its stress state or fatigue life. On the other hand, aspect ratio is a consistent criterion of thick wire fatigue life. Increasing the wire aspect ratio lowers its critical stress and increases its fatigue life. Moreover, we found that CucorAl wire has superior performance and longer fatigue life than Al wire.

  7. Reliability Criteria for Thick Bonding Wire

    Yavuz, Mustafa

    2018-01-01

    Bonding wire is one of the main interconnection techniques. Thick bonding wire is widely used in power modules and other high power applications. This study examined the case for extending the use of traditional thin wire reliability criteria, namely wire flexure and aspect ratio, to thick wires. Eleven aluminum (Al) and aluminum coated copper (CucorAl) wire samples with diameter 300 μm were tested experimentally. The wire response was measured using a novel non-contact method. High fidelity FEM models of the wire were developed and validated. We found that wire flexure is not correlated to its stress state or fatigue life. On the other hand, aspect ratio is a consistent criterion of thick wire fatigue life. Increasing the wire aspect ratio lowers its critical stress and increases its fatigue life. Moreover, we found that CucorAl wire has superior performance and longer fatigue life than Al wire. PMID:29673194

  8. Conventional Versus Rosemont Endoscopic Ultrasound Criteria for Chronic Pancreatitis: Comparing Interobserver Reliability and Intertest Agreement

    Bruce Kalmin

    2011-01-01

    Full Text Available BACKGROUND: The Rosemont criteria (RC were recently proposed by expert consensus to standardize endoscopic ultrasound (EUS features and thresholds for diagnosing chronic pancreatitis (CP; however, they are cumbersome and are not validated.

  9. Evidence-based provisional clinical classification criteria for autoinflammatory periodic fevers

    Federici, Silvia; Sormani, Maria Pia; Ozen, Seza; Lachmann, Helen J; Amaryan, Gayane; Woo, Patricia; Koné-Paut, Isabelle; Dewarrat, Natacha; Cantarini, Luca; Insalaco, Antonella; Uziel, Yosef; Rigante, Donato; Quartier, Pierre; Demirkaya, Erkan; Herlin, Troels; Meini, Antonella; Fabio, Giovanna; Kallinich, Tilmann; Martino, Silvana; Butbul, Aviel Yonatan; Olivieri, Alma; Kuemmerle-Deschner, Jasmin; Neven, Benedicte; Simon, Anna; Ozdogan, Huri; Touitou, Isabelle; Frenkel, Joost; Hofer, Michael; Martini, Alberto; Ruperto, Nicolino; Gattorno, Marco

    2015-01-01

    The objective of this work was to develop and validate a set of clinical criteria for the classification of patients affected by periodic fevers. Patients with inherited periodic fevers (familial Mediterranean fever (FMF); mevalonate kinase deficiency (MKD); tumour necrosis factor

  10. User perspectives on relevance criteria

    Maglaughlin, Kelly L.; Sonnenwald, Diane H.

    2002-01-01

    , partially relevant, or not relevant to their information need; and explained their decisions in an interview. Analysis revealed 29 criteria, discussed positively and negatively, that were used by the participants when selecting passages that contributed or detracted from a document's relevance......This study investigates the use of criteria to assess relevant, partially relevant, and not-relevant documents. Study participants identified passages within 20 document representations that they used to make relevance judgments; judged each document representation as a whole to be relevant...... matter, thought catalyst), full text (e.g., audience, novelty, type, possible content, utility), journal/publisher (e.g., novelty, main focus, perceived quality), and personal (e.g., competition, time requirements). Results further indicate that multiple criteria are used when making relevant, partially...

  11. Criteria for authorship in bioethics.

    Resnik, David B; Master, Zubin

    2011-10-01

    Multiple authorship is becoming increasingly common in bioethics research. There are well-established criteria for authorship in empirical bioethics research but not for conceptual research. It is important to develop criteria for authorship in conceptual publications to prevent undeserved authorship and uphold standards of fairness and accountability. This article explores the issue of multiple authorship in bioethics and develops criteria for determining who should be an author on a conceptual publication in bioethics. Authorship in conceptual research should be based on contributing substantially to: (1) identifying a topic, problem, or issue to study; (2) reviewing and interpreting the relevant literature; (3) formulating, analyzing, and evaluating arguments that support one or more theses; (4) responding to objections and counterarguments; and (5) drafting the manuscript. Authors of conceptual publications should participate substantially in at least two of areas (1)-(5) and also approve the final version. [corrected].

  12. Groundwater Model Validation

    Ahmed E. Hassan

    2006-01-24

    Models have an inherent uncertainty. The difficulty in fully characterizing the subsurface environment makes uncertainty an integral component of groundwater flow and transport models, which dictates the need for continuous monitoring and improvement. Building and sustaining confidence in closure decisions and monitoring networks based on models of subsurface conditions require developing confidence in the models through an iterative process. The definition of model validation is postulated as a confidence building and long-term iterative process (Hassan, 2004a). Model validation should be viewed as a process not an end result. Following Hassan (2004b), an approach is proposed for the validation process of stochastic groundwater models. The approach is briefly summarized herein and detailed analyses of acceptance criteria for stochastic realizations and of using validation data to reduce input parameter uncertainty are presented and applied to two case studies. During the validation process for stochastic models, a question arises as to the sufficiency of the number of acceptable model realizations (in terms of conformity with validation data). Using a hierarchical approach to make this determination is proposed. This approach is based on computing five measures or metrics and following a decision tree to determine if a sufficient number of realizations attain satisfactory scores regarding how they represent the field data used for calibration (old) and used for validation (new). The first two of these measures are applied to hypothetical scenarios using the first case study and assuming field data consistent with the model or significantly different from the model results. In both cases it is shown how the two measures would lead to the appropriate decision about the model performance. Standard statistical tests are used to evaluate these measures with the results indicating they are appropriate measures for evaluating model realizations. The use of validation

  13. Design criteria for advanced reactors

    Dennielou, Y.

    1991-01-01

    Design criteria for advanced reactors are discussed, including safety aspects, site selection, problems related to maintenance and possibility of repairing or replacing structures or components of a nuclear power plant, the human factor considerations. Bearing in mind that some of these criteria are the subject of consensus at international level, the author suggests to establish a table of different operator requirements, to prepare a dossier on the comparison of input data for probabilistic risk analysis, to take into consideration the means to control a severe accident from the very start of the design

  14. CRITERIA FOR INVESTING IN THE MARKET FOR THE VISUAL ARTS

    Elio Amílcar Farfán Torrelles

    2015-04-01

    Full Text Available The market in the visual arts develops a complex activity which requiring identify many key variables to establish valid investment criteria, as to obtain reasonable profits. This requires intentionality differentiate between investment purchase or collection. Then, fixing as the central axes of analysis to the work and the artist, is investigated and the trajectory of iconic and pop compared to identify the criteria that the buyer should consider when purchasing a work of visual art, and that due segmented to this economic activity, accurate to invest parameters are needed.

  15. OSCILLATION CRITERIA FOR FORCED SUPERLINEAR DIFFERENCE EQUATIONS

    2008-01-01

    Using Riccati transformation techniques,some oscillation criteria for the forced second-order superlinear difference equations are established.These criteria are dis- crete analogues of the criteria for differential equations proposed by Yan.

  16. [Reconsidering evaluation criteria regarding health care research: toward an integrative framework of quantitative and qualitative criteria].

    Miyata, Hiroaki; Kai, Ichiro

    2006-05-01

    Debate about the relationship between quantitative and qualitative paradigms is often muddled and confused and the clutter of terms and arguments has resulted in the concepts becoming obscure and unrecognizable. It is therefore very important to reconsider evaluation criteria regarding rigor in social science. As Lincoln & Guba have already compared quantitative paradigms (validity, reliability, neutrality, generalizability) with qualitative paradigms (credibility, dependability, confirmability, transferability), we have discuss use of evaluation criteria based on pragmatic perspective. Validity/Credibility is the paradigm concerned to observational framework, while Reliability/Dependability refer to the range of stability in observations, Neutrality/Confirmability reflect influences between observers and subjects, Generalizability/Transferability have epistemological difference in the way findings are applied. Qualitative studies, however, does not always chose the qualitative paradigms. If we assume the stability to some extent, it is better to use the quantitative paradigm (reliability). Moreover as a quantitative study can not always guarantee a perfect observational framework, with stability in all phases of observations, it is useful to use qualitative paradigms to enhance the rigor in the study.

  17. Validation philosophy

    Vornehm, D.

    1994-01-01

    To determine when a set of calculations falls within an umbrella of an existing validation documentation, it is necessary to generate a quantitative definition of range of applicability (our definition is only qualitative) for two reasons: (1) the current trend in our regulatory environment will soon make it impossible to support the legitimacy of a validation without quantitative guidelines; and (2) in my opinion, the lack of support by DOE for further critical experiment work is directly tied to our inability to draw a quantitative open-quotes line-in-the-sandclose quotes beyond which we will not use computer-generated values

  18. Accident analysis and DOE criteria

    Graf, J.M.; Elder, J.C.

    1982-01-01

    In analyzing the radiological consequences of major accidents at DOE facilities one finds that many facilities fall so far below the limits of DOE Order 6430 that compliance is easily demonstrated by simple analysis. For those cases where the amount of radioactive material and the dispersive energy available are enough for accident consequences to approach the limits, the models and assumptions used become critical. In some cases the models themselves are the difference between meeting the criteria or not meeting them. Further, in one case, we found that not only did the selection of models determine compliance but the selection of applicable criteria from different chapters of Order 6430 also made the difference. DOE has recognized the problem of different criteria in different chapters applying to one facility, and has proceeded to make changes for the sake of consistency. We have proposed to outline the specific steps needed in an accident analysis and suggest appropriate models, parameters, and assumptions. As a result we feed DOE siting and design criteria will be more fairly and consistently applied

  19. Aversive Stimulation -- Criteria for Application.

    O'Donnell, Patrick A.; Ohlson, Glenn A.

    Criteria for applying aversive stimulation with severely handicapped children are examined, and practical and ethical issues are considered. Factors seen to influence punishment outcomes include timing, intensity, and schedule of reinforcement. Suggested is the need for further research on the comparative effectiveness of positive and negative…

  20. Risk based seismic design criteria

    Kennedy, R.P.

    1999-01-01

    In order to develop a risk based seismic design criteria the following four issues must be addressed: (1) What target annual probability of seismic induced unacceptable performance is acceptable? (2) What minimum seismic margin is acceptable? (3) Given the decisions made under Issues 1 and 2, at what annual frequency of exceedance should the safe-shutdown-earthquake (SSE) ground motion be defined? (4) What seismic design criteria should be established to reasonably achieve the seismic margin defined under Issue 2? The first issue is purely a policy decision and is not addressed in this paper. Each of the other three issues are addressed. Issues 2 and 3 are integrally tied together so that a very large number of possible combinations of responses to these two issues can be used to achieve the target goal defined under Issue 1. Section 2 lays out a combined approach to these two issues and presents three potentially attractive combined resolutions of these two issues which reasonably achieves the target goal. The remainder of the paper discusses an approach which can be used to develop seismic design criteria aimed at achieving the desired seismic margin defined in resolution of Issue 2. Suggestions for revising existing seismic design criteria to more consistently achieve the desired seismic margin are presented. (orig.)

  1. Musculoskeletal ultrasound including definitions for ultrasonographic pathology

    Wakefield, RJ; Balint, PV; Szkudlarek, Marcin

    2005-01-01

    pathologies. This article presents the first report from the OMERACT ultrasound special interest group, which has compared US against the criteria of the OMERACT filter. Also proposed for the first time are consensus US definitions for common pathological lesions seen in patients with inflammatory arthritis....

  2. On the validation of risk analysis-A commentary

    Rosqvist, Tony

    2010-01-01

    Aven and Heide (2009) [1] provided interesting views on the reliability and validation of risk analysis. The four validation criteria presented are contrasted with modelling features related to the relative frequency-based and Bayesian approaches to risk analysis. In this commentary I would like to bring forth some issues on validation that partly confirm and partly suggest changes in the interpretation of the introduced validation criteria-especially, in the context of low probability-high consequence systems. The mental model of an expert in assessing probabilities is argued to be a key notion in understanding the validation of a risk analysis.

  3. Reflexive criteria of sociological research

    R T Ubaydullaeva

    2014-12-01

    Full Text Available The article is devoted to the sociological criteria of explaining the way of thinking and actions of subjects, their spiritual and moral positions and intellectual forces that form the laws of social life. The author seeks to adapt such categories as ‘meaning of life’, ‘human dignity’, ‘rationality’ etc. for the purposes of sociological analysis by methodological construction of some real life dichotomies such as ‘subjective meaning and social function’, ‘the real and the ideal’, ‘the demanded and the excluded’. Thus, the author studies economic, political and technical processes in terms of both positivity and negativity of social interaction and states that given the increasing differentiation of the society and the contradictory trends of social development the reflexive criteria that take into account the socio-cultural nature of the man help to find one’s own model of development.

  4. New facility shield design criteria

    Howell, W.P.

    1981-07-01

    The purpose of the criteria presented here is to provide standard guidance for the design of nuclear radiation shields thoughout new facilities. These criteria are required to assure a consistent and integrated design that can be operated safely and economically within the DOE standards. The scope of this report is confined to the consideration of radiation shielding for contained sources. The whole body dose limit established by the DOE applies to all doses which are generally distributed throughout the trunk of the body. Therefore, where the whole body is the critical organ for an internally deposited radionuclide, the whole body dose limit applies to the sum of doses received must assure control of the concentration of radionuclides in the building atmosphere and thereby limit the dose from internal sources

  5. NSSS supplier's response to differing safety criteria

    Cremades, J; Filkin, R; Franke, T [Westinghouse Electric Nuclear Energy Systems Europe (WENESE), Brussels (Belgium)

    1980-11-01

    The limited progress achieved to date in harmonizing national criteria has led to the development of designs which include the most common national requirements. Progress towards harmonization of safety criteria can be accelerated by expanding the IAEA leadership and co-ordination activities, and implementing an integrated approach to criteria development. National and International safety criteria are examined.

  6. Evaluating Dependence Criteria for Caffeine

    Striley, Catherine L.W.; Griffiths, Roland R.; Cottler, Linda B.

    2011-01-01

    Background: Although caffeine is the most widely used mood-altering drug in the world, few studies have operationalized and characterized Diagnostic and Statistical Manual IV (DSM-IV) substance dependence criteria applied to caffeine. Methods: As a part of a nosological study of substance use disorders funded by the National Institute on Drug Abuse, we assessed caffeine use and dependence symptoms among high school and college students, drug treatment patients, and pain clinic patients who re...

  7. Radiological criteria in nuclear emergencies

    Carrillo, D.; Diaz de la Cruz, F.

    1985-01-01

    It is pretended to enlighten the way to adopt the recommendations, from supranational organizations or the practices followed in other countries, to the peculiarities existing in Spain for the specific case of Nuclear Emergency Response Planning. The adaptation has been focalized in the criteria given by the Spanish Nuclear Safety Council and has taken into account the radiological protection levels, which have been considered adequate for Spanish population in case of nuclear accidents. (author)

  8. Sampling criteria in multicollection searching.

    Gilio, A.; Scozzafava, R.; Marchetti, P. G.

    In the first stage of the document retrieval process, no information concerning relevance of a particular document is available. On the other hand, computer implementation requires that the analysis be made only for a sample of retrieved documents. This paper addresses the significance and suitability of two different sampling criteria for a multicollection online search facility. The inevitability of resorting to a logarithmic criterion in order to achieve a "spread of representativeness" from the multicollection is demonstrated.

  9. Position paper: Seismic design criteria

    Farnworth, S.K.

    1995-01-01

    The purpose of this paper is to document the seismic design criteria to be used on the Title 11 design of the underground double-shell waste storage tanks and appurtenant facilities of the Multi-Function Waste Tank Facility (MWTF) project, and to provide the history and methodologies for determining the recommended Design Basis Earthquake (DBE) Peak Ground Acceleration (PGA) anchors for site-specific seismic response spectra curves. Response spectra curves for use in design are provided in Appendix A

  10. Hydraulic Design Criteria for Spacer Grids of Nuclear Fuel Element

    Juanico, Luis; Brasnarof, Daniel

    2000-01-01

    In this paper a hydraulic model for calculating the pressure drop on the CARA spacer grids is extended.This model is validated and feedback from experimental hydraulic test performed in a low pressure loop.The importance of the spacer grid geometric parameter (that is, its thickness and length, the number and kind of their fix spacer), developing hydraulic design criteria for spacer grid on fuel element

  11. Repository operational criteria comparative analysis

    Hageman, J.P.; Chowdhury, A.H.

    1994-06-01

    The objective of the ''Repository Operational Criteria (ROC) Feasibility Studies'' (or ROC task) was to conduct comprehensive and integrated analyses of repository design, construction, and operations criteria in 10 CFR Part 60 regulations considering the interfaces among the components of the regulations and impacts of any potential changes to those regulations. The ROC task addresses regulatory criteria and uncertainties related to the preclosure aspects of the geologic repository. Those parts of 10 CFR Part 60 that require routine guidance or minor changes to the rule were addressed in Hageman and Chowdhury, 1992. The ROC task shows a possible need for further regulatory clarity, by major changes to the rule, related to the design bases and siting of a geologic repository operations area and radiological emergency planning in order to assure defense-in-depth. The analyses, presented in this report, resulted in the development and refinement of regulatory concepts and their supporting rationale for recommendations for potential major changes to 10 CFR Pan 0 regulations

  12. Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications

    Schiffman, Eric; Ohrbach, Richard; Truelove, Edmond

    2014-01-01

    of the literature providing valid instruments that, relative to the RDC/TMD, are shorter in length, are available in the public domain, and currently are being used in medical settings. RESULTS: The newly recommended Diagnostic Criteria for TMD (DC/TMD) Axis I protocol includes both a valid screener for detecting...

  13. Reconsidering Evaluation Criteria for Scientific Adequacy in Health Care Research: An Integrative Framework of Quantitative and Qualitative Criteria

    Hiroaki Miyata PhD

    2009-03-01

    Full Text Available It is important to reconsider evaluation criteria regarding scientific adequacy in health care research. In this article the authors review the four pairs of quantitative/qualitative paradigms. They discuss the use of evaluation criteria based on a pragmatic perspective after examining the epistemological issues behind the criteria. Validity/credibility is concerned with research framework, whereas reliability/dependability refers to the range of stability in observations, objectivity/ confirmability reflects influences between observers and subjects, and generalizability/transferability has epistemological differences in the way findings are applied. Qualitative studies should not always choose qualitative paradigms, and vice versa. If stability can be assumed to some extent in a qualitative study, it is better to use a quantitative paradigm. Regardless of whether it is quantitative or qualitative research, it is important to recognize the four epistemological axes.

  14. How Turkey Meets MPOWER Criteria?

    Nazmi Bilir

    2013-02-01

    Full Text Available In 2003 World Health Assembly adopted an international treaty on tobacco control; FCTC, Framework Convention on Tobacco Control. Five year later World Health Organization (WHO declared the six effective approach for tobacco control, under the name of MPOWER. In the following years, WHO evaluated the level of implementation of MPOWER criteria in the countries. In this article, how Turkey implemented these six criteria will be discussed. Monitor tobacco use and prevention policies: Monitoring of tobacco use prevalence has been successfully monitored in Turkey through Global Adult Tobacco Survey, Global Youth Tobacco Survey and Health Professionals Tobacco Use Survey. Nevertheless, monitoring of tobacco industry activities was not successfully implemented. Protect people from tobacco smoke: Smoking was banned in most of the indoor public places in Turkey since 1996, and Turkey became a complete smoke-free country by the exposion of smoke-free places including the hospitality workplaces in 2008. Offer help to quit tobacco use: Although smoking cessation services has been a bit late in Turkey, availability of smoking cessation drugs and the establishment of free quitline services made Turkey successful in this regard. Warn about the dangers of tobacco: Since 1996, all TV channels have a duty of broadcasting programs on harms of tobacco use, not less than 90 minutes in a month and it has been implemented successfully. Additionally written messages indicating harms of tobacco has been printed on the packs since 1988 and pictures was added in 2010. But since the average surface area covered by the messages in less than 50% of the total surface of the pack, Turkey was not regarded as to meet the requirement. Enforce bans on tobacco advertising, promotion and sponsorship: All kinds of tobacco advertisement and promotion was banned by the Law in 1996. But the tobacco products was not in closed boxes at the sales points. Turkey was not found as successful

  15. Participatory flood vulnerability assessment: a multi-criteria approach

    M. M. de Brito

    2018-01-01

    Full Text Available This paper presents a participatory multi-criteria decision-making (MCDM approach for flood vulnerability assessment while considering the relationships between vulnerability criteria. The applicability of the proposed framework is demonstrated in the municipalities of Lajeado and Estrela, Brazil. The model was co-constructed by 101 experts from governmental organizations, universities, research institutes, NGOs, and private companies. Participatory methods such as the Delphi survey, focus groups, and workshops were applied. A participatory problem structuration, in which the modellers work closely with end users, was used to establish the structure of the vulnerability index. The preferences of each participant regarding the criteria importance were spatially modelled through the analytical hierarchy process (AHP and analytical network process (ANP multi-criteria methods. Experts were also involved at the end of the modelling exercise for validation. The final product is a set of individual and group flood vulnerability maps. Both AHP and ANP proved to be effective for flood vulnerability assessment; however, ANP is preferred as it considers the dependences among criteria. The participatory approach enabled experts to learn from each other and acknowledge different perspectives towards social learning. The findings highlight that to enhance the credibility and deployment of model results, multiple viewpoints should be integrated without forcing consensus.

  16. DSM-5 Criteria for Substance Use Disorders: Recommendations and Rationale

    Hasin, Deborah S.; O’Brien, Charles P.; Auriacombe, Marc; Borges, Guilherme; Bucholz, Kathleen; Budney, Alan; Compton, Wilson M.; Crowley, Thomas; Ling, Walter; Petry, Nancy M.; Schuckit, Marc; Grant, Bridget F.

    2013-01-01

    Since DSM-IV was published in 1994, its approach to substance use disorders has come under scrutiny. Strengths were identified (notably, reliability and validity of dependence), but concerns have also arisen. The DSM-5 Substance-Related Disorders Work Group considered these issues and recommended revisions for DSM-5. General concerns included whether to retain the division into two main disorders (dependence and abuse), whether substance use disorder criteria should be added or removed, and whether an appropriate substance use disorder severity indicator could be identified. Specific issues included possible addition of withdrawal syndromes for several substances, alignment of nicotine criteria with those for other substances, addition of biomarkers, and inclusion of nonsubstance, behavioral addictions. This article presents the major issues and evidence considered by the work group, which included literature reviews and extensive new data analyses. The work group recommendations for DSM-5 revisions included combining abuse and dependence criteria into a single substance use disorder based on consistent findings from over 200,000 study participants, dropping legal problems and adding craving as criteria, adding cannabis and caffeine withdrawal syndromes, aligning tobacco use disorder criteria with other substance use disorders, and moving gambling disorders to the chapter formerly reserved for substance-related disorders. The proposed changes overcome many problems, while further studies will be needed to address issues for which less data were available. PMID:23903334

  17. DSM-5 criteria for substance use disorders: recommendations and rationale.

    Hasin, Deborah S; O'Brien, Charles P; Auriacombe, Marc; Borges, Guilherme; Bucholz, Kathleen; Budney, Alan; Compton, Wilson M; Crowley, Thomas; Ling, Walter; Petry, Nancy M; Schuckit, Marc; Grant, Bridget F

    2013-08-01

    Since DSM-IV was published in 1994, its approach to substance use disorders has come under scrutiny. Strengths were identified (notably, reliability and validity of dependence), but concerns have also arisen. The DSM-5 Substance-Related Disorders Work Group considered these issues and recommended revisions for DSM-5. General concerns included whether to retain the division into two main disorders (dependence and abuse), whether substance use disorder criteria should be added or removed, and whether an appropriate substance use disorder severity indicator could be identified. Specific issues included possible addition of withdrawal syndromes for several substances, alignment of nicotine criteria with those for other substances, addition of biomarkers, and inclusion of nonsubstance, behavioral addictions.This article presents the major issues and evidence considered by the work group, which included literature reviews and extensive new data analyses. The work group recommendations for DSM-5 revisions included combining abuse and dependence criteria into a single substance use disorder based on consistent findings from over 200,000 study participants, dropping legal problems and adding craving as criteria, adding cannabis and caffeine withdrawal syndromes, aligning tobacco use disorder criteria with other substance use disorders, and moving gambling disorders to the chapter formerly reserved for substance-related disorders. The proposed changes overcome many problems, while further studies will be needed to address issues for which less data were available.

  18. Participatory flood vulnerability assessment: a multi-criteria approach

    Madruga de Brito, Mariana; Evers, Mariele; Delos Santos Almoradie, Adrian

    2018-01-01

    This paper presents a participatory multi-criteria decision-making (MCDM) approach for flood vulnerability assessment while considering the relationships between vulnerability criteria. The applicability of the proposed framework is demonstrated in the municipalities of Lajeado and Estrela, Brazil. The model was co-constructed by 101 experts from governmental organizations, universities, research institutes, NGOs, and private companies. Participatory methods such as the Delphi survey, focus groups, and workshops were applied. A participatory problem structuration, in which the modellers work closely with end users, was used to establish the structure of the vulnerability index. The preferences of each participant regarding the criteria importance were spatially modelled through the analytical hierarchy process (AHP) and analytical network process (ANP) multi-criteria methods. Experts were also involved at the end of the modelling exercise for validation. The final product is a set of individual and group flood vulnerability maps. Both AHP and ANP proved to be effective for flood vulnerability assessment; however, ANP is preferred as it considers the dependences among criteria. The participatory approach enabled experts to learn from each other and acknowledge different perspectives towards social learning. The findings highlight that to enhance the credibility and deployment of model results, multiple viewpoints should be integrated without forcing consensus.

  19. Verification, validation, and reliability of predictions

    Pigford, T.H.; Chambre, P.L.

    1987-04-01

    The objective of predicting long-term performance should be to make reliable determinations of whether the prediction falls within the criteria for acceptable performance. Establishing reliable predictions of long-term performance of a waste repository requires emphasis on valid theories to predict performance. The validation process must establish the validity of the theory, the parameters used in applying the theory, the arithmetic of calculations, and the interpretation of results; but validation of such performance predictions is not possible unless there are clear criteria for acceptable performance. Validation programs should emphasize identification of the substantive issues of prediction that need to be resolved. Examples relevant to waste package performance are predicting the life of waste containers and the time distribution of container failures, establishing the criteria for defining container failure, validating theories for time-dependent waste dissolution that depend on details of the repository environment, and determining the extent of congruent dissolution of radionuclides in the UO 2 matrix of spent fuel. Prediction and validation should go hand in hand and should be done and reviewed frequently, as essential tools for the programs to design and develop repositories. 29 refs

  20. ACL Return to Sport Guidelines and Criteria.

    Davies, George J; McCarty, Eric; Provencher, Matthew; Manske, Robert C

    2017-09-01

    Because of the epidemiological incidence of anterior cruciate ligament (ACL) injuries, the high reinjury rates that occur when returning back to sports, the actual number of patients that return to the same premorbid level of competition, the high incidence of osteoarthritis at 5-10-year follow-ups, and the effects on the long-term health of the knee and the quality of life for the patient, individualizing the return to sports after ACL reconstruction (ACL-R) is critical. However, one of the challenging but unsolved dilemmas is what criteria and clinical decision making should be used to return an athlete back to sports following an ACL-R. This article describes an example of a functional testing algorithm (FTA) as one method for clinical decision making based on quantitative and qualitative testing and assessment utilized to make informed decisions to return an athlete to their sports safely and without compromised performance. The methods were a review of the best current evidence to support a FTA. In order to evaluate all the complicated domains of the clinical decision making for individualizing the return to sports after ACL-R, numerous assessments need to be performed including the biopsychosocial concepts, impairment testing, strength and power testing, functional testing, and patient-reported outcomes (PROs). The optimum criteria to use for individualizing the return to sports after ACL-R remain elusive. However, since this decision needs to be made on a regular basis with the safety and performance factors of the patient involved, this FTA provides one method of quantitatively and qualitatively making the decisions. Admittedly, there is no predictive validity of this system, but it does provide practical guidelines to facilitate the clinical decision making process for return to sports. The clinical decision to return an athlete back into competition has significant implications ranging from the safety of the athlete, to performance factors and actual

  1. Can we decide which outcomes should be measured in every clinical trial? A scoping review of the existing conceptual frameworks and processes to develop core outcome sets.

    Idzerda, Leanne; Rader, Tamara; Tugwell, Peter; Boers, Maarten

    2014-05-01

    The usefulness of randomized control trials to advance clinical care depends upon the outcomes reported, but disagreement on the choice of outcome measures has resulted in inconsistency and the potential for reporting bias. One solution to this problem is the development of a core outcome set: a minimum set of outcome measures deemed critical for clinical decision making. Within rheumatology the Outcome Measures in Rheumatology (OMERACT) initiative has pioneered the development of core outcome sets since 1992. As the number of diseases addressed by OMERACT has increased and its experience in formulating core sets has grown, clarification and update of the conceptual framework and formulation of a more explicit process of area/domain core set development has become necessary. As part of the update process of the OMERACT Filter criteria to version 2, a literature review was undertaken to compare and contrast the OMERACT conceptual framework with others within and outside rheumatology. A scoping search was undertaken to examine the extent, range, and nature of conceptual frameworks for core set outcome selection in health. We searched the following resources: Cochrane Library Methods Group Register; Medline; Embase; PsycInfo; Environmental Studies and Policy Collection; and ABI/INFORM Global. We also conducted a targeted Google search. Five conceptual frameworks were identified: the WHO tripartite definition of health; the 5 Ds (discomfort, disability, drug toxicity, dollar cost, and death); the International Classification of Functioning (ICF); PROMIS (Patient-Reported Outcomes Measurement System); and the Outcomes Hierarchy. Of these, only the 5 Ds and ICF frameworks have been systematically applied in core set development. Outside the area of rheumatology, several core sets were identified; these had been developed through a limited range of consensus-based methods with varying degrees of methodological rigor. None applied a framework to ensure content validity of

  2. DISPOSABLE CANISTER WASTE ACCEPTANCE CRITERIA

    R.J. Garrett

    2001-07-30

    The purpose of this calculation is to provide the bases for defining the preclosure limits on radioactive material releases from radioactive waste forms to be received in disposable canisters at the Monitored Geologic Repository (MGR) at Yucca Mountain. Specifically, this calculation will provide the basis for criteria to be included in a forthcoming revision of the Waste Acceptance System Requirements Document (WASRD) that limits releases in terms of non-isotope-specific canister release dose-equivalent source terms. These criteria will be developed for the Department of Energy spent nuclear fuel (DSNF) standard canister, the Multicanister Overpack (MCO), the naval spent fuel canister, the High-Level Waste (HLW) canister, the plutonium can-in-canister, and the large Multipurpose Canister (MPC). The shippers of such canisters will be required to demonstrate that they meet these criteria before the canisters are accepted at the MGR. The Quality Assurance program is applicable to this calculation. The work reported in this document is part of the analysis of DSNF and is performed using procedure AP-3.124, Calculations. The work done for this analysis was evaluated according to procedure QAP-2-0, Control of Activities, which has been superseded by AP-2.21Q, Quality Determinations and Planning for Scientific, Engineering, and Regulatory Compliance Activities. This evaluation determined that such activities are subject to the requirements of DOE/RW/0333P, Quality Assurance Requirements and Description (DOE 2000). This work is also prepared in accordance with the development plan titled Design Basis Event Analyses on DOE SNF and Plutonium Can-In-Canister Waste Forms (CRWMS M&O 1999a) and Technical Work Plan For: Department of Energy Spent Nuclear Fuel Work Packages (CRWMS M&O 2000d). This calculation contains no electronic data applicable to any electronic data management system.

  3. Diagnosing autoimmune pancreatitis with the Unifying-Autoimmune-Pancreatitis-Criteria.

    Schneider, Alexander; Michaely, Henrik; Rückert, Felix; Weiss, Christel; Ströbel, Philipp; Belle, Sebastian; Hirth, Michael; Wilhelm, Torsten J; Haas, Stephan L; Jesenofsky, Ralf; Schönberg, Stefan; Marx, Alexander; Singer, Manfred V; Ebert, Matthias P; Pfützer, Roland H; Löhr, J Matthias

    We had developed the Unifying-Autoimmune-Pancreatitis-Criteria (U-AIP) to diagnose autoimmune pancreatitis (AiP) within the M-ANNHEIM classification of chronic pancreatitis. In 2011, International-Consensus-Diagnostic-Criteria (ICDC) to diagnose AiP have been published. We had applied the U-AIP long before the ICDC were available. The aims of the study were, first, to describe patients with AiP diagnosed by the U-AIP; second, to compare diagnostic accuracies of the U-AIP and other diagnostic systems; third, to evaluate the clinical applicability of the U-AIP. From 1998 until 2008, we identified patients with AiP using U-AIP, Japanese-, Korean-, Asian-, Mayo-HISORt-, Revised-Mayo-HISORt- and Italian-criteria. We retrospectively verified the diagnosis by ICDC and Revised-Japanese-2011-criteria, compared diagnostic accuracies of all systems and evaluated all criteria in consecutive patients with pancreatitis (2009 until 2010, Pancreas-Outpatient-Clinic-Cohort, n = 84). We retrospectively validated our diagnostic approach in consecutive patients with a pancreatic lesion requiring surgery (Surgical-Cohort, n = 98). Overall, we identified 21 patients with AiP. Unifying-Autoimmune-Pancreatitis-Criteria and ICDC presented the highest diagnostic accuracies (each 98.8%), highest Youden indices (each 0.95238), and highest proportions of diagnosed patients (each n = 20/21, U-AIP/ICDC vs. other diagnostic systems, p Pancreatitis-Criteria revealed a satisfactory clinical applicability and offered an additional approach to diagnose AiP. Copyright © 2017 IAP and EPC. Published by Elsevier B.V. All rights reserved.

  4. Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications

    Schiffman, Eric; Ohrbach, Richard; Truelove, Edmond

    2014-01-01

    AIMS: The original Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) Axis I diagnostic algorithms have been demonstrated to be reliable. However, the Validation Project determined that the RDC/TMD Axis I validity was below the target sensitivity of ≥ 0.70 and specificity of ≥...... comprehensive instruments augment short and simple screening instruments for Axis I and Axis II. These validated instruments allow for identification of patients with a range of simple to complex TMD presentations....

  5. Productive Regions: Criteria and Classification

    Vlasyuk L. I.

    2012-03-01

    Full Text Available An official statistical dataset for 80 territorial subjects of the Russian Federation for 2000, 2007 and 2009 has proved the hypothesis that, under the neoclassical concept, the resources move to regions with the highest marginal productivity of the factors of production, which leads to the accumulation of investment resources, while providing financial and social efficiency. Based on cluster analysis by three performance criteria, productive regions are identified, which are dominated by regions productive in the extraction of minerals. It is shown that the stability of the factors’ distribution in space determines the current and future specialization of regional economies

  6. Training review criteria and procedures

    1993-01-01

    This document provides direction to NRC personnel for reviewing training programs at nuclear power plants to verify compliance with the requirements of 10 CFR 50. 120 and 10 CFR 55 as applicable. It describes the process for evaluating the effectiveness of training programs, provides aids for collection of information during interviews and observations, and provides criteria for evaluating the implementation of a systems approach to training. This document is not intended to have the effect of a regulation, it establishes no binding requirements or interpretations of NRC regulations. It is intended as guidance only

  7. Quality criteria for landscape visualisation

    Waldi, H.-P.; Witt, U. de

    1996-01-01

    The rapid expansion of wind energy utilisation in Western Europe can strain the limits of social acceptance with citizens living in wind development areas. One of the problems wind farm engineers and local authorities face is the visual impact of wind turbines. To determine the influence on the landscape visualisations of wind farms photorealistic compositions are used. In many cases it is part of the planning procedure. The quality of this visualization can strongly influence the success of the permission procedure. We will give criteria which can give help to reduce the possibility of unwanted manipulations. (author)

  8. Assessment of juveniles testimonies’ validity

    Dozortseva E.G.

    2015-12-01

    Full Text Available The article presents a review of the English language publications concerning the history and the current state of differential psychological assessment of validity of testimonies produced by child and adolescent victims of crimes. The topicality of the problem in Russia is high due to the tendency of Russian specialists to use methodical means and instruments developed abroad in this sphere for forensic assessments of witness testimony veracity. A system of Statement Validity Analysis (SVA by means of Criteria-Based Content Analysis (CBCA and Validity Checklist is described. The results of laboratory and field studies of validity of CBCA criteria on the basis of child and adult witnesses are discussed. The data display a good differentiating capacity of the method, however, a high level of error probability. The researchers recommend implementation of SVA in the criminal investigation process, but not in the forensic assessment. New perspective developments in the field of methods for differentiation of witness statements based on the real experience and fictional are noted. The conclusion is drawn that empirical studies and a special work for adaptation and development of new approaches should precede their implementation into Russian criminal investigation and forensic assessment practice

  9. Ventilation criteria for IDMS facility

    Lambert, D.P.

    1996-01-01

    Both Facility Evaluation Board (FEB) reviews of the Integrated DWPF Melter System (IDMS) have identified the inconsistency of the current IDMS Process Hazards Review (PHR) versus actual IDMS practice as regards the criteria to contain air borne pollutants that may be present in the Process Room (e.g. benzene and mercury). The PHR states that a 1.0 in. wc pressure differential be maintained between the IDMS Process Room and Building 672-T. In addition, the PHR further specifies that the linear velocity through openings into the Process Room (e.g. open doors) be equal to or greater than 150 fpm. Finally, the PHR recommended that mercury vapor and benzene monitors be installed in the Process Room ventilation exhaust to alert personnel to the presence of vapors of benzene and/or mercury before entering the Process Room. This report summarizes the results of reassessment of these criteria and the specific recommendation for permanent installation of mercury and benzene vapor monitors in the vapor exhaust of the Process Room

  10. Donor selection criteria and procurement

    Agcaoili, N.R.

    1999-01-01

    Donor selection is one of the most important aspects of tissue banking practice. Without a good donor selection criteria, the results of any effort of trying to preserve tissues will have disastrous outcome for the recipient of these tissues. While with a very good and strict donor selection the Tissue Bank can guarantee safe and effective tissue allografts. There are significant aspects in the history and physical examination of the donor that must be emphasized. A donor exclusion criteria has also been formulated together with a list of all the needed laboratory examinations to eliminate possible diseases that may be transferred from the donor. The methods of procurement of tissue allografts from living and cadaver donors will be described. The limitations and advantages of each will be taken.There are also special restrictions that are important in the practice of removing the tissues from the donors. All the necessary equipment should be ready and the potential risk on the personnel should be known to all doing Tissue Banking

  11. Nuclear reactor philosophy and criteria

    Atchison, R.J.

    1979-07-01

    Nuclear power plant safety criteria and principles developed in Canada are directed towards minimizing the chance of failure of the fuel and preventing or reducing to an acceptably low level the escape of fission products should fuel failure occur. Safety criteria and practices are set forth in the Reactor Siting Guide, which is based upon the concept of defence in depth. The Guide specifies that design and construction shall follow the best applicable code, standard or practice; the total of all serious process system failures shall not exceed one in three years; special safety systems are to be physically and functionally separate from process systems and each other; and safety systems shall be testable, with unavailability less than 10 - 3 . Doses to the most exposed member of the public due to normal operation, serious process failures, and dual failures are specified. Licensees are also required to consider the effects of extreme conditions due to airplane crashes, explosions, turbine disintegration, pipe burst, and natural disasters. Safety requirements are changing as nuclear power plant designs evolve and in response to social and economic pressures

  12. Multi-criteria decision making with overlapping criteria

    Mohammed Shahid Abdulla

    2012-09-01

    Full Text Available The evidential reasoning (ER algorithm for multi-criteria decision making (MCDM performs aggregation of the assessments of multiple experts, one each for every attribute (or subsystem or criterion of a given system. Two variants of ER are proposed, that handle a scenario where more than one expert assesses an attribute. The first algorithm handles the case of multiple experts who assess an attribute of a larger system. Experiments compare a modification of ER for this scenario which results in poorer detection. The second algorithm is used when experts have overlapping areas of expertise among the subsystems. A comparison is made with a variant of ER in the literature. Both algorithms are examples of novel ‘exclusive’ and ‘inclusive’ ER.

  13. 45 CFR 1176.3 - Criteria.

    2010-10-01

    ... ENDOWMENT FOR THE HUMANITIES PART-TIME CAREER EMPLOYMENT § 1176.3 Criteria. Positions becoming vacant... to part-time. Among the criteria which may be used when conducting this review are: (a) Mission...

  14. 40 CFR 258.24 - Air criteria.

    2010-07-01

    ... SOLID WASTE LANDFILLS Operating Criteria § 258.24 Air criteria. (a) Owners or operators of all MSWLFs... wastes, silvicultural wastes, landclearing debris, diseased trees, or debris from emergency cleanup...

  15. Qualitative vs. quantitative atopic dermatitis criteria

    Andersen, R M; Thyssen, J P; Maibach, H I

    2016-01-01

    This review summarizes historical aspects, clinical expression and pathophysiology leading to coining of the terms atopy and atopic dermatitis, current diagnostic criteria and further explore the possibility of developing quantitative diagnostic criteria of atopic dermatitis (AD) based on the imp...

  16. Separability criteria for genuine multiparticle entanglement

    Guhne, O.; Seevinck, M.P.|info:eu-repo/dai/nl/304847399

    2010-01-01

    We present a method to derive separability criteria for different classes of multiparticle entanglement, especially genuine multiparticle entanglement. The resulting criteria are necessary and sufficient for certain families of states. This, for example, completely solves the problem of classifying

  17. Separability Criteria for Genuine Multiparticle Entanglement

    Guehne, O.; Seevinck, M.P.

    2010-01-01

    We present a method to derive separability criteria for different classes of multiparticle entanglement, especially genuine multiparticle entanglement. The resulting criteria are necessary and sufficient for certain families of states. This, for example, completely solves the problem of classifying

  18. Criteria for onsite transfers of radioactive material

    Opperman, E.K.; Jackson, E.J.; Eggers, A.G.

    1992-01-01

    A general description of the requirements for making onsite transfers of radioactive material is provided in Chapter 2, along with the required sequencey of activities. Various criteria for package use are identified in Chapters 3-13. These criteria provide protection against undue radiation exposure. Package shielding, containment, and surface contamination requirements are established. Criteria for providing criticality safety are enumerated in Chapter 6. Criteria for providing hazards information are established in Chapter 13. A glossary is provided

  19. Design criteria for plutonium gloveboxes

    Anon.

    1981-01-01

    The standard defines criteria for the design of glovebox systems to be used for the handling of plutonium in any form or isotopic composition or when mixed with other elements or compounds. The glovebox system is a series of physical barriers provided with glove ports and gloves, through which process and maintenance operations may be performed, together with an operating ventilation system. The system minimizes the potential for release of radioactive material to the environment, protects operators from contamination, and mitigates the consequences of abnormal condiations. The standard covers confinement, construction, materials, windows, glove ports, gloves, equipment insertion and removal, lighting, ventilation, fire protection, criticality prevention, services and utilities, radiation shielding, waste systems, monitoring and alarm systems, safeguards, quality assurance, and decommissioning

  20. 10 CFR 905.36 - Marketing criteria.

    2010-01-01

    ... 10 Energy 4 2010-01-01 2010-01-01 false Marketing criteria. 905.36 Section 905.36 Energy DEPARTMENT OF ENERGY ENERGY PLANNING AND MANAGEMENT PROGRAM Power Marketing Initiative § 905.36 Marketing criteria. Western shall retain applicable provisions of existing marketing criteria for projects where...

  1. 46 CFR 385.51 - Criteria: Projects.

    2010-10-01

    ... results; (iii) The extent of the problems treated and whether the objectives sought by the undertaking are... MARITIME ADMINISTRATION, DEPARTMENT OF TRANSPORTATION MISCELLANEOUS RESEARCH AND DEVELOPMENT GRANT AND COOPERATIVE AGREEMENTS REGULATIONS Criteria for Award § 385.51 Criteria: Projects. The criteria to be used by...

  2. Expanding the taxonomy of the diagnostic criteria for temporomandibular disorders.

    Peck, C C; Goulet, J-P; Lobbezoo, F; Schiffman, E L; Alstergren, P; Anderson, G C; de Leeuw, R; Jensen, R; Michelotti, A; Ohrbach, R; Petersson, A; List, T

    2014-01-01

    There is a need to expand the current temporomandibular disorders' (TMDs) classification to include less common but clinically important disorders. The immediate aim was to develop a consensus-based classification system and associated diagnostic criteria that have clinical and research utility for less common TMDs. The long-term aim was to establish a foundation, vis-à-vis this classification system, that will stimulate data collection, validity testing and further criteria refinement. A working group [members of the International RDC/TMD Consortium Network of the International Association for Dental Research (IADR), members of the Orofacial Pain Special Interest Group (SIG) of the International Association for the Study of Pain (IASP), and members from other professional societies] reviewed disorders for inclusion based on clinical significance, the availability of plausible diagnostic criteria and the ability to operationalise and study the criteria. The disorders were derived from the literature when possible and based on expert opinion as necessary. The expanded TMDs taxonomy was presented for feedback at international meetings. Of 56 disorders considered, 37 were included in the expanded taxonomy and were placed into the following four categories: temporomandibular joint disorders, masticatory muscle disorders, headache disorders and disorders affecting associated structures. Those excluded were extremely uncommon, lacking operationalised diagnostic criteria, not clearly related to TMDs, or not sufficiently distinct from disorders already included within the taxonomy. The expanded TMDs taxonomy offers an integrated approach to clinical diagnosis and provides a framework for further research to operationalise and test the proposed taxonomy and diagnostic criteria. © 2014 John Wiley & Sons Ltd.

  3. EULAR/PRINTO/PRES criteria for Henoch-Schönlein purpura, childhood polyarteritis nodosa, childhood Wegener granulomatosis and childhood Takayasu arteritis: Ankara 2008. Part II: Final classification criteria

    Ozen, Seza; Pistorio, Angela; Iusan, Silvia M

    2010-01-01

    To validate the previously proposed classification criteria for Henoch-Schönlein purpura (HSP), childhood polyarteritis nodosa (c-PAN), c-Wegener granulomatosis (c-WG) and c-Takayasu arteritis (c-TA)....

  4. How to Use the ADI-R for Classifying Autism Spectrum Disorders? Psychometric Properties of Criteria from the Literature in 1,204 Dutch Children

    de Bildt, Annelies; Oosterling, Iris J.; van Lang, Natasja D. J.; Kuijper, Sanne; Dekker, Vera; Sytema, Sjoerd; Oerlemans, Anoek M.; van Steijn, Daphne J.; Visser, Janne C.; Rommelse, Nanda N.; Minderaa, Ruud B.; van Engeland, Herman; van der Gaag, Rutger-Jan; Buitelaar, Jan K.; de Jonge, Maretha V.

    2013-01-01

    The algorithm of the Autism Diagnostic Interview-Revised provides criteria for autism versus non-autism according to DSM-IV. Criteria for the broader autism spectrum disorders are needed. This study investigated the validity of seven sets of criteria from the literature, in 1,204 Dutch children (aged 3-18 years) with and without mental…

  5. An assessment of the present criteria for cathodic protection of buried steel pipelines

    Barlo, T.J.; Berry, W.E.

    1984-01-01

    An experimental laboratory study has been conducted to assess the criteria for cathodic protection of a buried pipeline. The specific cathodicprotection potential requirements to prevent pitting and general corrosion of steel were determined in six natural soils with various amounts of moisture and oxygen (aerated or deaerated), and were compared to the criteria values of -0.85 V (Cu/CuSO 4 ), 100 mV polarization, 300 mV voltage shift, and Tafel potential. The effects of temperature 60 0 C (140 0 F) anaerobic bacteria, and steel surface condition (bare or mill scaled) on the specific requirements in selected soils were assessed also. Overall, the research concluded the present criteria were generally valid in concept; however, the critical values for the present criteria could vary with the environment, but with one noted exception. This experimental study concluded that the 100 mV polarization criterion was the most generally valid and applicable criterion

  6. Research into care quality criteria for long-term care institutions.

    Wang, Wen-Liang; Chang, Hong-Jer; Liu, An-Chi; Chen, Yu-Wen

    2007-12-01

    The purpose of this paper was to determine the criteria that reflect the quality of care provided by long-term care institutions. Research was conducted using a two-step procedure that first utilized the SERVQUAL model with Fuzzy Delphi Method to establish the proper criteria by which service quality could be measured. A total of 200 questionnaires were mailed to expert respondents, of which 89 were returned and 77 deemed valid for use in this study. We then applied the Multi-Criteria Decision Making Process to determine the degree of importance of each criterion to long-term care institution service quality planning work. Secondly, 200 questionnaires were distributed and 74 valid responses were returned. Based on the 5 SERVQUAL model constructs, this study found 17 of the 28 criteria, to be pertinent to nursing care quality, with those in the Responsiveness and Empathy domains being the ones most critical.

  7. Selection criteria for dental radiography

    1998-01-01

    The Faculty of General Dental Practitioners (UK) has a declared commitment to 'improving the standards of patient care'. By the provision of standards and guidelines it aims to help the profession to achieve this goal. Standards and guidelines are simply tools a dentist may use to improve treatment planning and care outcomes. The Self-Assessment Manual and Standards, SAMS, first published in 1991, is now well known to the profession and has become a frequently quoted source in clinical audit and quality assurance initiatives. Since its publication the scientific methodology of systematic reviews of the literature has progressed dramatically and this book is based on these developments. Evidence-based care is well established in medicine and dentistry and these selection criteria and guidelines follow these established protocols by basing advice on the available scientific evidence wherever possible. This book's purpose is a practical one, it is not intended to be limiting or restrictive but to be useful in the decision-making process. This is the first in a series of standards documents from the FGDP(UK) which are based on reviews of the scientific literature and employ the Scottish Intercollegiate Guideline Network (SIGN) methodology for guideline production. They are not constraints but an aid to effective treatment planning and patient care

  8. Criteria for exact qudit universality

    Brennen, Gavin K.; O'Leary, Dianne P.; Bullock, Stephen S.

    2005-01-01

    We describe criteria for implementation of quantum computation in qudits. A qudit is a d-dimensional system whose Hilbert space is spanned by states vertical bar 0>, vertical bar 1>, ..., vertical bar d-1>. An important earlier work [A. Muthukrishnan and C.R. Stroud, Jr., Phys. Rev. A 62, 052309 (2000)] describes how to exactly simulate an arbitrary unitary on multiple qudits using a 2d-1 parameter family of single qudit and two qudit gates. That technique is based on the spectral decomposition of unitaries. Here we generalize this argument to show that exact universality follows given a discrete set of single qudit Hamiltonians and one two-qudit Hamiltonian. The technique is related to the QR-matrix decomposition of numerical linear algebra. We consider a generic physical system in which the single qudit Hamiltonians are a small collection of H jk x =(ℎ/2π)Ω(vertical bar k> jk y =(ℎ/2π)Ω(i vertical bar k> jk x,y are allowed Hamiltonians. One qudit exact universality follows iff this graph is connected, and complete universality results if the two-qudit Hamiltonian H=(ℎ/2π)Ω vertical bar d-1,d-1> 87 Rb and construct an optimal gate sequence using Raman laser pulses

  9. Complete family of separability criteria

    Doherty, Andrew C.; Spedalieri, Federico M.; Parrilo, Pablo A.

    2004-01-01

    We introduce a family of separability criteria that are based on the existence of extensions of a bipartite quantum state ρ to a larger number of parties satisfying certain symmetry properties. It can be easily shown that all separable states have the required extensions, so the nonexistence of such an extension for a particular state implies that the state is entangled. One of the main advantages of this approach is that searching for the extension can be cast as a convex optimization problem known as a semidefinite program. Whenever an extension does not exist, the dual optimization constructs an explicit entanglement witness for the particular state. These separability tests can be ordered in a hierarchical structure whose first step corresponds to the well-known positive partial transpose (Peres-Horodecki) criterion, and each test in the hierarchy is at least as powerful as the preceding one. This hierarchy is complete, in the sense that any entangled state is guaranteed to fail a test at some finite point in the hierarchy, thus showing it is entangled. The entanglement witnesses corresponding to each step of the hierarchy have well-defined and very interesting algebraic properties that, in turn, allow for a characterization of the interior of the set of positive maps. Coupled with some recent results on the computational complexity of the separability problem, which has been shown to be NP hard, this hierarchy of tests gives a complete and also computationally and theoretically appealing characterization of mixed bipartite entangled states

  10. Criteria for onset of firestorms

    Carrier, G.F.; Fendell, F.E.; Feldman, P.S.

    1983-01-01

    Quantitative criteria are evolved for onset of firestorms, severe stationary (nonpropagating) holocausts arising via merger of fires from multiple simultaneous ignitions in a heavily fuel-laden urban environment. Within an hour, surface-level radial inflow from all directions sustains a large-diameter convective column that eventually reaches altitude of about 10 km (e.g., Hamburg, Dresden, Hiroshima). As the firestorm achieves peak intensity (2 to 3 hours after the ignitions), inflow speeds are inferred to attain 25 to 50 m/s; typically 12 km 2 are reduced to ashes, before winds relax to ambient levels in six-to-nine hours. Here the firestorm is interpreted to be a mesocyclone (rotating severe local storm). Even with exceedingly large heat release sustained over a concentrated area, in the presence of a very nearly autoconvectively unstable atmospheric stratification, onset of vigorous swirling on the scale of two hours requires more than concentration of circulation associated with the rotation of the earth; rather, a preexisting, if weak, circulation appears necessary for firestorm cyclogenesis

  11. Diversification criteria for power systems

    Kharbach, Mohammed

    2016-01-01

    Growing power demand, fuel availability and prices, technology changes, the environmental impacts of energy consumption, the changing regulatory environments and the uncertainties around such elements make the planning for optimal power mix a challenging task. The diversity approach is advocated as a most appropriate planning methodology for the optimal energy mix (Hickey et al., 2010). Shannon Wiener Index (SWI), which is the most cited diversity metric has been used to assess power systems diversity mainly from an energy perspective. To our best knowledge, there is no rigorous justification why energy has been the main variable used in diversification exercises rather than other variables such as capacity. We use a stylized power generation framework to show that diversity based on energy or capacity could lead to different outcomes in terms of vulnerability to fuel exposure, among others. We also introduce a Shannon Wiener Index ratio (SWIR) that we believe captures better the diversity of a power system compared to the standard SWI. - Highlights: • Ranking power systems, from a diversity perspective, based on one criteria has many shortcomings. • Diversity based on energy or capacity could lead to different outcomes in terms of vulnerability to fuel exposure, among others. • A Shannon Wiener Index ratio (SWIR) captures better the diversity of a power system compared to the standard SWI.

  12. Panel 1: Safety design criteria

    Yllera, Javier

    2013-01-01

    There is general consensus in the nuclear community, and more after the Fukushima accident, that the deployment of nuclear energy has to be done at the highest levels of nuclear safety and that safety cannot be compromised by other factors. It is well understood that reactors that are being licensed and the new generations of reactors that will be constructed in the future will need to reach higher safety levels than the existing ones. Several countries and international organizations or international groups are launching initiatives to harmonise safety goals, safety requirements, safety objectives, regulations, criteria or safety reference levels. There are differences in the meanings of these terms and the working approaches, but the overall purpose is the same: to specify how new plants can be safer. In this context, the IAEA has an statutory function for developing international nuclear safety standards. The IAEA safety standards are per se not mandatory for IAEA Member States. Regulating safety is a national responsibility, and many States have decided to adopt the IAEA’s standards for use in their national regulations in different ways. The IAEA Safety Standards represent international consensus on what must constitute a high level of safety for nuclear installations. In the area of NPP design, IAEA safety standards that are published are intended to apply primarily to new plants. It might not be practicable to apply all the requirements to plants that are already in operation. In addition, the focus is primarily on plants with water cooled reactors

  13. Investigation of Sustainable Housing Criteria

    roshanfekr Somayeh

    2016-01-01

    Full Text Available Recently, much attention has been paid to sustainable development in cities. The quality of human life is directly related to environmental quality. Because many people live in cities as a place of social, economic and cultural relationships, certain issues such as environmental crises, energy, air and noise pollution and traffic jams are some of the factors that can alter the quality of human life. Therefore, in order to improve the quality of human life, attention to sustainable development (or sustainability in cities is proposed. Sustainable building has a comprehensive significance that begins with the conception of negative and positive impacts on the environment. Several descriptions of sustainable or green buildings have been created; however, they all pursue one goal, which is to create sustainable urban developments and protection of the environment. The quality of indoor environments, materials, and energy consumption, water usage, the impact of building construction processes and building maintenance are some of the factors that affect the environment and sustainability. Sustainable building is an attempt to relieve the minus impacts on the environment that occur during a building’s lifetime. This research investigates the important factors that have relevance to green buildings and introduces several criteria of sustainable housing.

  14. Diagnostic criteria in MR neurography

    Baeumer, P.

    2017-01-01

    Peripheral neuropathies are frequent and can mostly be correctly diagnosed by clinical examination and electrophysiology; however, diagnostically difficult cases are sometimes encountered especially with respect to precise localization of nerve lesions. Imaging of the peripheral nervous system has been shown to provide additional useful diagnostic information. In addition to the more widely available nerve sonography, magnetic resonance neurography (MRN) is the method of choice in diagnostically complex cases. The most important pulse sequence is a T2-weighted fat-saturated pulse sequence with high in-plane resolution and detects increased T2-weighted signals of nerve fascicles as a highly sensitive sign for nerve lesions. Further established diagnostic criteria are nerve caliber and, less commonly used, contrast agent uptake. The spatial pattern of nerve lesions aids in the diagnostic classification of neuropathies. Functional imaging techniques, such as diffusion tensor imaging (DTI) and nerve perfusion are currently under examination with respect to the clinical potential. If all other diagnostic methods, including clinical examination, electrophysiology and nerve sonography do not arrive at an unambiguous diagnosis of a peripheral neuropathy, MRN should be used. The special value of MRN is demonstrated particularly in complex nerve lesions, such as traumatic plexopathies and in partial fascicular neuropathies and many other indications. (orig.) [de

  15. Bioethics and conflicting ethical criteria.

    George, Michael

    2002-01-01

    Some of the major problematic issues in contemporary ethical discourse are highlighted in the field of bioethics. The need to incorporate new understandings and foundational shifts in essential criteria because of technological advances in the areas of medicine and human sciences increasingly challenges traditional and accepted notions of ethics. As the possibilities of technical progress increase, more and more pressure is put on traditional understandings of the human person, identity, and value. In the face of ethical relativism and emotivism, which are already widespread in social and political discourse, the immediacy of bioethics as a response to technology and its impact on human lives reinforces the need for ethics to become interdisciplinary, while attempting to provide some coherence to both the questions and the responses that contemporary life generates. In this paper, the author intends to sketch the outlines of some of these problems, and suggest one approach which might allow a certain methodical intelligibility to emerge which takes into account shifts in consciousness and the dependence on historically grounded perspective.

  16. Overview of core designs and requirements/criteria for core restraint systems

    Sutherland, W.H.

    1984-09-01

    The requirements and lifetime criteria for the design of a Liquid Metal Fast Breeder Reactor (LMFBR) Core Restraint System are presented. A discussion of the three types of core restraint systems used in LMFBR core design is given. Details of the core restraint system selected for FFTF are presented and the reasons for this selection given. Structural analysis procedures being used to manage the FFTF assembly irradiations are discussed. Efforts that are ongoing to validate the calculational methods and lifetime criteria are presented

  17. A Framework for the Development and Interpretation of Different Sepsis Definitions and Clinical Criteria.

    Angus, Derek C; Seymour, Christopher W; Coopersmith, Craig M; Deutschman, Clifford S; Klompas, Michael; Levy, Mitchell M; Martin, Gregory S; Osborn, Tiffany M; Rhee, Chanu; Watson, R Scott

    2016-03-01

    Although sepsis was described more than 2,000 years ago, and clinicians still struggle to define it, there is no "gold standard," and multiple competing approaches and terms exist. Challenges include the ever-changing knowledge base that informs our understanding of sepsis, competing views on which aspects of any potential definition are most important, and the tendency of most potential criteria to be distributed in at-risk populations in such a way as to hinder separation into discrete sets of patients. We propose that the development and evaluation of any definition or diagnostic criteria should follow four steps: 1) define the epistemologic underpinning, 2) agree on all relevant terms used to frame the exercise, 3) state the intended purpose for any proposed set of criteria, and 4) adopt a scientific approach to inform on their usefulness with regard to the intended purpose. Usefulness can be measured across six domains: 1) reliability (stability of criteria during retesting, between raters, over time, and across settings), 2) content validity (similar to face validity), 3) construct validity (whether criteria measure what they purport to measure), 4) criterion validity (how new criteria fare compared to standards), 5) measurement burden (cost, safety, and complexity), and 6) timeliness (whether criteria are available concurrent with care decisions). The relative importance of these domains of usefulness depends on the intended purpose, of which there are four broad categories: 1) clinical care, 2) research, 3) surveillance, and 4) quality improvement and audit. This proposed methodologic framework is intended to aid understanding of the strengths and weaknesses of different approaches, provide a mechanism for explaining differences in epidemiologic estimates generated by different approaches, and guide the development of future definitions and diagnostic criteria.

  18. A generic approach for steel containment vessel success criteria for severe accident loads

    Sammataro, R.F.; Solonick, W.R.; Edwards, N.W.

    1993-01-01

    Safety has been defined as the foremost design criterion for the Heavy Water New Production Reactor (NPR-HWR) by the U.S. DOE, Office of New Production Reactors (NP). The DOE-NP issued the Deterministic Severe Accident Criteria (DSAC) concept to guide the design of the NPR-HWR containment for resistance to severe accidents. The DSAC concept provides for a generic approach for containment vessel success criteria to predict the threshold of containment failure under severe accident loads. This concept consists of two parts: (1) Problem Statements and (2) Success Criteria. The paper is limited to a discussion of a success criteria. These criteria define acceptable containment response measures and limits for each problem statement. The criteria are based on the 'best estimate' of failure with no conservatism. Rather, conservatism, if required, is to be provided in the problem statements prepared by the designer and/or the regulatory authorities. The success criteria are presented on a multi-tiered basis for static pressure and temperature loadings, dynamic loadings, and missiles that may impact the containment. Within the static pressure and temperature loadings and the dynamic loadings, the criteria are separated into elastic analysis success criteria and inelastic analysis success criteria. Each of these areas, in turn, defines limits on either the stress or strain measures as well as on measures for buckling and displacements. The rationale upon which these criteria are based is contained in referenced documents. Rigorous validation of the criteria by comparison with results from analytical or experimental programs and application of the criteria to a containment design remain as future tasks. (orig./HP)

  19. Alternative microbial methods: An overview and selection criteria.

    Jasson, Vicky; Jacxsens, Liesbeth; Luning, Pieternel; Rajkovic, Andreja; Uyttendaele, Mieke

    2010-09-01

    This study provides an overview and criteria for the selection of a method, other than the reference method, for microbial analysis of foods. In a first part an overview of the general characteristics of rapid methods available, both for enumeration and detection, is given with reference to relevant bibliography. Perspectives on future development and the potential of the rapid method for routine application in food diagnostics are discussed. As various alternative "rapid" methods in different formats are available on the market, it can be very difficult for a food business operator or for a control authority to select the most appropriate method which fits its purpose. Validation of a method by a third party, according to international accepted protocol based upon ISO 16140, may increase the confidence in the performance of a method. A list of at the moment validated methods for enumeration of both utility indicators (aerobic plate count) and hygiene indicators (Enterobacteriaceae, Escherichia coli, coagulase positive Staphylococcus) as well as for detection of the four major pathogens (Salmonella spp., Listeria monocytogenes, E. coli O157 and Campylobacter spp.) is included with reference to relevant websites to check for updates. In a second part of this study, selection criteria are introduced to underpin the choice of the appropriate method(s) for a defined application. The selection criteria link the definition of the context in which the user of the method functions - and thus the prospective use of the microbial test results - with the technical information on the method and its operational requirements and sustainability. The selection criteria can help the end user of the method to obtain a systematic insight into all relevant factors to be taken into account for selection of a method for microbial analysis. Copyright 2010 Elsevier Ltd. All rights reserved.

  20. Performance of Different Diagnostic Criteria for Familial Mediterranean Fever in Children with Periodic Fevers : Results from a Multicenter International Registry

    Demirkaya, Erkan; Saglam, Celal; Turker, Turker; Koné-Paut, Isabelle; Woo, Pat; Doglio, Matteo; Amaryan, Gayane; Frenkel, Joost; Uziel, Yosef; Insalaco, Antonella; Cantarini, Luca; Hofer, Michael; Boiu, Sorina; Duzova, Ali; Modesto, Consuelo; Bryant, Annette; Rigante, Donato; Papadopoulou-Alataki, Efimia; Guillaume-Czitrom, Severine; Kuemmerle-Deschner, Jasmine; Neven, Bénédicte; Lachmann, Helen; Martini, Alberto; Ruperto, Nicolino; Gattorno, Marco; Ozen, Seza

    2015-01-01

    OBJECTIVE: Our aims were to validate the pediatric diagnostic criteria in a large international registry and to compare them with the performance of previous criteria for the diagnosis of familial Mediterranean fever (FMF). METHODS: Pediatric patients with FMF from the Eurofever registry were used

  1. Surrogate Endpoint Evaluation: Principal Stratification Criteria and the Prentice Definition.

    Gilbert, Peter B; Gabriel, Erin E; Huang, Ying; Chan, Ivan S F

    2015-09-01

    A common problem of interest within a randomized clinical trial is the evaluation of an inexpensive response endpoint as a valid surrogate endpoint for a clinical endpoint, where a chief purpose of a valid surrogate is to provide a way to make correct inferences on clinical treatment effects in future studies without needing to collect the clinical endpoint data. Within the principal stratification framework for addressing this problem based on data from a single randomized clinical efficacy trial, a variety of definitions and criteria for a good surrogate endpoint have been proposed, all based on or closely related to the "principal effects" or "causal effect predictiveness (CEP)" surface. We discuss CEP-based criteria for a useful surrogate endpoint, including (1) the meaning and relative importance of proposed criteria including average causal necessity (ACN), average causal sufficiency (ACS), and large clinical effect modification; (2) the relationship between these criteria and the Prentice definition of a valid surrogate endpoint; and (3) the relationship between these criteria and the consistency criterion (i.e., assurance against the "surrogate paradox"). This includes the result that ACN plus a strong version of ACS generally do not imply the Prentice definition nor the consistency criterion, but they do have these implications in special cases. Moreover, the converse does not hold except in a special case with a binary candidate surrogate. The results highlight that assumptions about the treatment effect on the clinical endpoint before the candidate surrogate is measured are influential for the ability to draw conclusions about the Prentice definition or consistency. In addition, we emphasize that in some scenarios that occur commonly in practice, the principal strata sub-populations for inference are identifiable from the observable data, in which cases the principal stratification framework has relatively high utility for the purpose of effect

  2. Surrogate Endpoint Evaluation: Principal Stratification Criteria and the Prentice Definition

    Gilbert, Peter B.; Gabriel, Erin E.; Huang, Ying; Chan, Ivan S.F.

    2015-01-01

    A common problem of interest within a randomized clinical trial is the evaluation of an inexpensive response endpoint as a valid surrogate endpoint for a clinical endpoint, where a chief purpose of a valid surrogate is to provide a way to make correct inferences on clinical treatment effects in future studies without needing to collect the clinical endpoint data. Within the principal stratification framework for addressing this problem based on data from a single randomized clinical efficacy trial, a variety of definitions and criteria for a good surrogate endpoint have been proposed, all based on or closely related to the “principal effects” or “causal effect predictiveness (CEP)” surface. We discuss CEP-based criteria for a useful surrogate endpoint, including (1) the meaning and relative importance of proposed criteria including average causal necessity (ACN), average causal sufficiency (ACS), and large clinical effect modification; (2) the relationship between these criteria and the Prentice definition of a valid surrogate endpoint; and (3) the relationship between these criteria and the consistency criterion (i.e., assurance against the “surrogate paradox”). This includes the result that ACN plus a strong version of ACS generally do not imply the Prentice definition nor the consistency criterion, but they do have these implications in special cases. Moreover, the converse does not hold except in a special case with a binary candidate surrogate. The results highlight that assumptions about the treatment effect on the clinical endpoint before the candidate surrogate is measured are influential for the ability to draw conclusions about the Prentice definition or consistency. In addition, we emphasize that in some scenarios that occur commonly in practice, the principal strata sub-populations for inference are identifiable from the observable data, in which cases the principal stratification framework has relatively high utility for the purpose of

  3. Application of a Framework to Assess the Usefulness of Alternative Sepsis Criteria.

    Seymour, Christopher W; Coopersmith, Craig M; Deutschman, Clifford S; Gesten, Foster; Klompas, Michael; Levy, Mitchell; Martin, Gregory S; Osborn, Tiffany M; Rhee, Chanu; Warren, David K; Watson, R Scott; Angus, Derek C

    2016-03-01

    The current definition of sepsis is life-threatening, acute organ dysfunction secondary to a dysregulated host response to infection. Criteria to operationalize this definition can be judged by six domains of usefulness (reliability, content, construct and criterion validity, measurement burden, and timeliness). The relative importance of these six domains depends on the intended purpose for the criteria (clinical care, basic and clinical research, surveillance, or quality improvement [QI] and audit). For example, criteria for clinical care should have high content and construct validity, timeliness, and low measurement burden to facilitate prompt care. Criteria for surveillance or QI/audit place greater emphasis on reliability across individuals and sites and lower emphasis on timeliness. Criteria for clinical trials require timeliness to ensure prompt enrollment and reasonable reliability but can tolerate high measurement burden. Basic research also tolerates high measurement burden and may not need stability over time. In an illustrative case study, we compared examples of criteria designed for clinical care, surveillance and QI/audit among 396,241 patients admitted to 12 academic and community hospitals in an integrated health system. Case rates differed four-fold and mortality three-fold. Predictably, clinical care criteria, which emphasized timeliness and low burden and therefore used vital signs and routine laboratory tests, had the greater case identification with lowest mortality. QI/audit criteria, which emphasized reliability and criterion validity, used discharge information and had the lowest case identification with highest mortality. Using this framework to identify the purpose and apply domains of usefulness can help with the evaluation of existing sepsis diagnostic criteria and provide a roadmap for future work.

  4. Incidence of Complex Regional Pain Syndrome I Following Foot and Ankle Fractures Using the Budapest Criteria.

    Bullen, Michael; Lang, Coran; Tran, Phong

    2016-12-01

    OBJECTIVE : Fractures are a well-recognized inciting event in the development of complex regional pain syndrome. This study aimed to prospectively determine the incidence of complex regional pain syndrome following foot and ankle fractures. METHODS : A prospective study was conducted of patients presenting to two metropolitan hospitals with plain radiograph diagnosis of fractures to the foot or ankle. Patients were initially screened by phone 3 months after injury using the validated International Association for the Study of Pain Budapest criteria. Patients who fulfilled the screening criteria were then physically examined by a pain specialist to assess clinical signs as part of the Budapest criteria. RESULTS : A total of 306 consecutive eligible patients were included. One hundred and ten patients reported at least one symptom of complex regional pain syndrome; however, only three fulfilled the minimum requirements to necessitate clinical review. Of these three, only one patient fulfilled the combination of symptom and sign criteria for a positive diagnosis according to the validated Budapest criteria. The incidence of complex regional pain syndrome following foot and ankle fracture in this study was 0.3%. CONCLUSION : Although many patients may experience vasomotor, sensory, and sudomotor disturbance following a fracture to the foot and ankle, the observed incidence of complex regional pain syndrome using a prospectively collected validated criteria is significantly lower than previously published. © 2016 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  5. Systemic inflammatory response syndrome criteria in defining severe sepsis.

    Kaukonen, Kirsi-Maija; Bailey, Michael; Pilcher, David; Cooper, D Jamie; Bellomo, Rinaldo

    2015-04-23

    The consensus definition of severe sepsis requires suspected or proven infection, organ failure, and signs that meet two or more criteria for the systemic inflammatory response syndrome (SIRS). We aimed to test the sensitivity, face validity, and construct validity of this approach. We studied data from patients from 172 intensive care units in Australia and New Zealand from 2000 through 2013. We identified patients with infection and organ failure and categorized them according to whether they had signs meeting two or more SIRS criteria (SIRS-positive severe sepsis) or less than two SIRS criteria (SIRS-negative severe sepsis). We compared their characteristics and outcomes and assessed them for the presence of a step increase in the risk of death at a threshold of two SIRS criteria. Of 1,171,797 patients, a total of 109,663 had infection and organ failure. Among these, 96,385 patients (87.9%) had SIRS-positive severe sepsis and 13,278 (12.1%) had SIRS-negative severe sepsis. Over a period of 14 years, these groups had similar characteristics and changes in mortality (SIRS-positive group: from 36.1% [829 of 2296 patients] to 18.3% [2037 of 11,119], P<0.001; SIRS-negative group: from 27.7% [100 of 361] to 9.3% [122 of 1315], P<0.001). Moreover, this pattern remained similar after adjustment for baseline characteristics (odds ratio in the SIRS-positive group, 0.96; 95% confidence interval [CI], 0.96 to 0.97; odds ratio in the SIRS-negative group, 0.96; 95% CI, 0.94 to 0.98; P=0.12 for between-group difference). In the adjusted analysis, mortality increased linearly with each additional SIRS criterion (odds ratio for each additional criterion, 1.13; 95% CI, 1.11 to 1.15; P<0.001) without any transitional increase in risk at a threshold of two SIRS criteria. The need for two or more SIRS criteria to define severe sepsis excluded one in eight otherwise similar patients with infection, organ failure, and substantial mortality and failed to define a transition point in

  6. Multi-Criteria Analysis to Prioritize Energy Sources for Ambience in Poultry Production

    DC Collatto

    Full Text Available ABSTRACT This paper intends to outline a model of multi-criteria analysis to pinpoint the most suitable energy source for heating aviaries in poultry broiler production from the point of view of the farmer and under environmental logic. Therefore, the identification of criteria was enabled through an exploratory study in three poultry broiler production units located in the mountain region of Rio Grande do Sul. In order to identify the energy source, the Analytic Hierarchy Process was applied. The criteria determined and validated in the research contemplated the cost of energy source, leadtime, investment in equipment, energy efficiency, quality of life and environmental impacts. The result of applying the method revealed firewood as the most appropriate energy for heating. The decision support model developed could be replicated in order to strengthen the criteria and energy alternatives presented, besides identifying new criteria and alternatives that were not considered in this study.

  7. Diagnostic accuracy of the Salzburg EEG criteria for non-convulsive status epilepticus

    Leitinger, Markus; Trinka, Eugen; Gardella, Elena

    2016-01-01

    Background Several EEG criteria have been proposed for diagnosis of non-convulsive status epilepticus (NCSE), but none have been clinically validated. We aimed to assess the diagnostic accuracy of the EEG criteria proposed by a panel of experts at the fourth London–Innsbruck Colloquium on Status...... Epilepticus in Salzburg, 2013 (henceforth called the Salzburg criteria). Methods We did a retrospective, diagnostic accuracy study using EEG recordings from patients admitted for neurological symptoms or signs to three centres in two countries (Danish Epilepsy Centre, Dianalund, Denmark; Aarhus University...

  8. The validated sun exposure questionnaire

    Køster, B; Søndergaard, J; Nielsen, J B

    2017-01-01

    Few questionnaires used in monitoring sun-related behavior have been tested for validity. We established criteria validity of a developed questionnaire for monitoring population sun-related behavior. During May-August 2013, 664 Danes wore a personal electronic UV-dosimeter for one week...... that measured the outdoor time and dose of erythemal UVR exposure. In the following week, they answered a questionnaire on their sun-related behavior in the measurement week. Outdoor time measured by dosimetry correlated strongly with both outdoor time and the developed exposure scale measured...... in the questionnaire. Exposure measured in SED by dosimetry correlated strongly with the exposure scale. In a linear regression model of UVR (SED) received, 41 percent of the variation was explained by skin type, age, week of participation and the exposure scale, with the exposure scale as the main contributor...

  9. Selection of response criteria for clinical trials of sarcoma treatment.

    Schuetze, Scott M; Baker, Laurence H; Benjamin, Robert S; Canetta, Renzo

    2008-01-01

    Soft tissue sarcomas are a heterogeneous group of malignancies arising from mesenchymal tissues. A large number of new therapies are being evaluated in patients with sarcomas, and consensus criteria defining treatment responses are essential for comparison of results from studies completed by different research groups. The 1979 World Health Organization (WHO) handbook set forth operationally defined criteria for response evaluation in solid tumors that were updated in 2000 with the publication of the Response Evaluation Criteria in Solid Tumors (RECIST). There have been significant advances in tumor imaging, however, that are not reflected in the RECIST. For example, computed tomography (CT) slice thickness has been reduced from 10 mm to < or =2.5 mm, allowing for more reproducible and accurate measurement of smaller lesions. Combination of imaging techniques, such as positron emission tomography with fluorine-18-fluorodeoxyglucose (18FDG-PET) and CT can provide investigators and clinicians with both anatomical and functional information regarding tumors, and there is now a large body of evidence demonstrating the effectiveness of PET/CT and other newer imaging methods for the detection and staging of tumors as well as early determination of responses to therapy. The application of newer imaging methods has the potential to decrease both the sample sizes required for, and duration of, clinical trials by providing an early indication of therapeutic response that is well correlated with clinical outcomes, such as time to tumor progression or overall survival. The results summarized in this review support the conclusion that the RECIST and the WHO criteria for evaluation of response in solid tumors need to be modernized. In addition, there is a current need for prospective trials to compare new response criteria with established endpoints and to validate imaging-based response rates as surrogate endpoints for clinical trials of new agents for sarcoma and other solid

  10. Radiological protection criteria for waste management

    Hill, M.D.; Webb, G.A.M.

    1985-01-01

    In this paper the progress being made by international organisations towards the development of a consensus on the radiological protection criteria to be applied to waste management, and in particular waste disposal, is reviewed. Against this background, work on the development of criteria for use in the UK is described. It is concluded that an international consensus is emerging and that the criteria being recommended for use in the UK are consistent with current international views. (author)

  11. Radiological protection criteria for waste management

    Hill, M.D.; Webb, G.A.M.

    1985-01-01

    In this Paper the progress being made by international organizations towards the development of a consensus on the radiological protection criteria to be applied to waste management, and in particular waste disposal, is reviewed. Against this background, work on the development of criteria for use in the UK is described. It is concluded that an international consensus is emerging and that the criteria being recommended for use in the UK are consistent with current international views. (author)

  12. Criteria for Evaluating Oral History Interviews.

    Fonsino, Frank J.

    1980-01-01

    Discusses the rationale for establishing criteria for evaluating oral history interviews. Presents seven evaluation categories relating to oral history tapes and three categories relating to typescripts. (CK)

  13. Criteria for operator review of workplace changes

    Davey, E.

    2000-01-01

    A set of criteria for reviewing workplace changes has been developed for use by plant Operations staff. The criteria were developed to provide Operations staff with a practical framework for structuring assessments and subsequent review comments with regard to control room modifications and innovations that impact their work environment. The criteria were assembled from design, operations and human factors engineering principles, and system review experiences with plant Operations staff over the past ten years. Operations staff at several CANDU stations helped shape the emphasis for initial criteria definition and have assisted with criteria refinement through trial applications. Use of the criteria is expected to lead to more effective and task relevant equipment evaluations by Operations staff, and ultimately lead to system modifications and innovations that better serve plant operation needs. The paper begins with a discussion of the rationale for criteria development and the attributes of 'good' design. The balance of the paper outlines the project objectives, describes the approach applied in assembling, structuring, and refining the review criteria, and illustrates the application of the criteria in the review of a proposed control room innovation. (author)

  14. What to Do With "Moderate" Reliability and Validity Coefficients?

    Post, Marcel W

    Clinimetric studies may use criteria for test-retest reliability and convergent validity such that correlation coefficients as low as .40 are supportive of reliability and validity. It can be argued that moderate (.40-.60) correlations should not be interpreted in this way and that reliability

  15. Return to Play After Hamstring Injuries: A Qualitative Systematic Review of Definitions and Criteria.

    van der Horst, Nick; van de Hoef, Sander; Reurink, Gustaaf; Huisstede, Bionka; Backx, Frank

    2016-06-01

    More than half of the recurrent hamstring injuries occur within the first month after return-to-play (RTP). Although there are numerous studies on RTP, comparisons are hampered by the numerous definitions of RTP used. Moreover, there is no consensus on the criteria used to determine when a person can start playing again. These criteria need to be critically evaluated, in an attempt to reduce recurrence rates and optimize RTP. To carry out a systematic review of the literature on (1) definitions of RTP used in hamstring research and (2) criteria for RTP after hamstring injuries. Systematic review. Seven databases (PubMed, EMBASE/MEDLINE, CINAHL, PEDro, Cochrane, SPORTDiscus, Scopus) were searched for articles that provided a definition of, or criteria for, RTP after hamstring injury. There were no limitations on the methodological design or quality of articles. Content analysis was used to record and analyze definitions and criteria for RTP after hamstring injury. Twenty-five papers fulfilled inclusion criteria, of which 13 provided a definition of RTP and 23 described criteria to support the RTP decision. "Reaching the athlete's pre-injury level" and "being able to perform full sport activities" were the primary content categories used to define RTP. "Absence of pain", "similar strength", "similar flexibility", "medical staff clearance", and "functional performance" were core themes to describe criteria to support the RTP decision after hamstring injury. Only half of the included studies provided some definition of RTP after hamstring injury, of which reaching the athlete's pre-injury level and being able to perform full sport activities were the most important. A wide variety of criteria are used to support the RTP decision, none of which have been validated. More research is needed to reach a consensus on the definition of RTP and to provide validated RTP criteria to facilitate hamstring injury management and reduce hamstring injury recurrence. PROSPERO

  16. Return to play criteria after hamstring muscle injury in professional football: a Delphi consensus study.

    Zambaldi, Mattia; Beasley, Ian; Rushton, Alison

    2017-08-01

    Hamstring muscle injury (HMI) is the most common injury in professional football and has a high re-injury rate. Despite this, there are no validated criteria to support return to play (RTP) decisions. To use the Delphi method to reach expert consensus on RTP criteria after HMI in professional football. All professional football clubs in England (n=92) were invited to participate in a 3-round Delphi study. Round 1 requested a list of criteria used for RTP decisions after HMI. Responses were independently collated by 2 researchers under univocal definitions of RTP criteria. In round 2 participants rated their agreement for each RTP criterion on a 1-5 Likert Scale. In round 3 participants re-rated the criteria that had reached consensus in round 2. Descriptive statistics and Kendall's coefficient of concordance enabled interpretation of consensus. Participation rate was limited at 21.7% (n=20), while retention rate was high throughout the 3 rounds (90.0%, 85.0%, 90.0%). Round 1 identified 108 entries with varying definitions that were collated into a list of 14 RTP criteria. Rounds 2 and 3 identified 13 and 12 criteria reaching consensus, respectively. Five domains of RTP assessment were identified: functional performance, strength, flexibility, pain and player's confidence. The highest-rated criteria were in the functional performance domain, with particular importance given to sprint ability. This study defined a list of consensually agreed RTP criteria for HMI in professional football. Further work is now required to determine the validity of the identified criteria. © 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.

  17. NWTS program criteria for mined geologic disposal of nuclear wasite: site performance criteria

    1981-02-01

    This report states ten criteria governing the suitability of sites for mined geologic disposal of high-level radioactive waste. The Department of Energy will use these criteria in its search for sites and will reevaluate their use when the Nuclear Regulatory Commission issues radioactive waste repository rules. These criteria encompass site geometry, geohydrology, geochemistry, geologic characteristics, tectonic environment, human intrusion, surface characteristics, environment, and potential socioeconomic impacts. The contents of this document include background discussion, site performance criteria, and appendices. The background section describes the waste disposal system, the application of the site criteria, and applicable criteria from NWTS-33(1) - Program Objectives, Functional Requirements and System Performance Criteria. Appendix A, entitled Comparison with Other Siting Criteria compares the NWTS criteria with those recommended by other agencies. Appendix B contains DOE responses to public comments received on the January 1980 draft of this document. Appendix C is a glossary

  18. Analysis of patterns of three-phase bone scintigraphy for patients with complex regional pain syndrome diagnosed using the proposed research criteria (the 'Budapest Criteria').

    Moon, J Y; Park, S Y; Kim, Y C; Lee, S C; Nahm, F S; Kim, J H; Kim, H; Oh, S W

    2012-04-01

    Three-phase bone scintigraphy (TPBS) is an established objective diagnostic method for complex regional pain syndrome (CRPS), but its validity remains controversial. The aims of this study were: (i) to re-evaluate the diagnostic performance of TPBS, and (ii) to suggest new TPBS criteria based on the proposed research criteria for CPRS in Budapest (the 2003 Budapest research criteria). The medical records of 228 consecutive patients, evaluated using the Budapest research criteria, were retrospectively analysed. Of these, 116 patients were included in the present study, and 69 of 116 were diagnosed to have CRPS based on these criteria. The diagnostic performance of TPBS was assessed by determining its sensitivity, specificity, and positive and negative likelihood ratios, and new criteria for TPBS were identified by pattern analysis using the Budapest research criteria. The sensitivity, specificity, positive likelihood ratio, and negative likelihood ratio of TPBS for the diagnosis of CRPS according to the Budapest research criteria were 40.0, 76.5, 1.73, and 0.78, respectively. Furthermore, D-D-D, D-D-S, and D-D-I patterns [i.e. according to decreased (D), symmetrical (S), or increased (I) tracer uptake during Phases I, II, and III] of TPBS were found to be positively predictive for CRPS. The diagnostic value of a positive TPBS for CRPS is low from the view point of the Budapest research criteria. Our findings suggest that a diagnosis of CRPS using the Budapest research criteria should be considered when decreased patterns of TPBS are observed during Phases I and II.

  19. Intermittent explosive disorder: development of integrated research criteria for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.

    Coccaro, Emil F

    2011-01-01

    This study was designed to develop a revised diagnostic criteria set for intermittent explosive disorder (IED) for consideration for inclusion in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V). This revised criteria set was developed by integrating previous research criteria with elements from the current DSM-IV set of diagnostic criteria. Evidence supporting the reliability and validity of IED-IR ("IED Integrated Criteria") in a new and well-characterized group of subjects with personality disorder is presented. Clinical, phenomenologic, and diagnostic data from 201 individuals with personality disorder were reviewed. All IED diagnoses were assigned using a best-estimate process (eg, kappa for IED-IR >0.85). In addition, subjects meeting IED-IR criteria had higher scores on dimensional measures of aggression and had lower global functioning scores than non-IED-IR subjects, even when related variables were controlled. The IED-IR criteria were more sensitive than the DSM-IV criteria only in identifying subjects with significant impulsive-aggressive behavior by a factor of 16. We conclude that the IED-IR criteria can be reliably applied and have sufficient validity to warrant consideration as DSM-V criteria for IED. Copyright © 2011 Elsevier Inc. All rights reserved.

  20. CisLunar Habitat Internal Architecture Design Criteria

    Jones, R.; Kennedy, K.; Howard, R.; Whitmore, M.; Martin, C.; Garate, J.

    2017-01-01

    BACKGROUND: In preparation for human exploration to Mars, there is a need to define the development and test program that will validate deep space operations and systems. In that context, a Proving Grounds CisLunar habitat spacecraft is being defined as the next step towards this goal. This spacecraft will operate differently from the ISS or other spacecraft in human history. The performance envelope of this spacecraft (mass, volume, power, specifications, etc.) is being defined by the Future Capabilities Study Team. This team has recognized the need for a human-centered approach for the internal architecture of this spacecraft and has commissioned a CisLunar Phase-1 Habitat Internal Architecture Study Team to develop a NASA reference configuration, providing the Agency with a "smart buyer" approach for future acquisition. THE CISLUNAR HABITAT INTERNAL ARCHITECTURE STUDY: Overall, the CisLunar Habitat Internal Architecture study will address the most significant questions and risks in the current CisLunar architecture, habitation, and operations concept development. This effort is achieved through definition of design criteria, evaluation criteria and process, design of the CisLunar Habitat Phase-1 internal architecture, and the development and fabrication of internal architecture concepts combined with rigorous and methodical Human-in-the-Loop (HITL) evaluations and testing of the conceptual innovations in a controlled test environment. The vision of the CisLunar Habitat Internal Architecture Study is to design, build, and test a CisLunar Phase-1 Habitat Internal Architecture that will be used for habitation (e.g. habitability and human factors) evaluations. The evaluations will mature CisLunar habitat evaluation tools, guidelines, and standards, and will interface with other projects such as the Advanced Exploration Systems (AES) Program integrated Power, Avionics, Software (iPAS), and Logistics for integrated human-in-the-loop testing. The mission of the Cis

  1. Validation of hospital discharge diagnoses for hypertensive disorders of pregnancy

    Møller Luef, Birgitte; Andersen, Louise B; Renault, Kristina Martha

    2016-01-01

    INTRODUCTION: A correct diagnosis of preeclampsia and gestational hypertension is important for treatment and epidemiological studies. Changes in diagnostic criteria and underreporting in certain subsets of patients may hamper validity of the diagnoses. MATERIALS AND METHODS: We validated....... After validation, significantly more patients fulfilled criteria for diagnosis of preeclampsia (n = 163, 7.5%, p = 0.002); more had severe preeclampsia, 14 (0.6%) vs. 70 (3.2%), p hypertension, 62 (2.9%) vs. 46 (2.1%), p = 0.12. The diagnostic sensitivity for preeclampsia...... of hypertensive disorders in pregnancy for research purposes....

  2. Construct Validity and Case Validity in Assessment

    Teglasi, Hedwig; Nebbergall, Allison Joan; Newman, Daniel

    2012-01-01

    Clinical assessment relies on both "construct validity", which focuses on the accuracy of conclusions about a psychological phenomenon drawn from responses to a measure, and "case validity", which focuses on the synthesis of the full range of psychological phenomena pertaining to the concern or question at hand. Whereas construct validity is…

  3. Transferability of Skills: Convergent, Postdictive, Criterion-Related, and Construct Validation of Cross-Job Retraining Time Estimates

    Kavanagh, Michael

    1997-01-01

    ... (job learning difficulty and cross-AFS differences in aptitude requirements), (b) XJRThs exhibited some postdictive validity when evaluated against Airman Retraining Program Survey retraining ease criteria, (c...

  4. 16 CFR 1031.15 - Communication criteria.

    2010-01-01

    ... nature and a report of each oral communication of a substantive nature between a Commission official or... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Communication criteria. 1031.15 Section 1031... Communication criteria. (a) Commission officials and employees, who are not in the positions listed in § 1031.12...

  5. Who and Racist criteria on CT

    Servente, L.

    2012-01-01

    This presentation is about Who and Recist criteria on CT.These are rules to the evaluation of the solid tumors treatment response as well as different concepts of measurability criteria of blastic changes, target /non target lesions, adenopathies, lytic, cystic , non-measurable disease and progressive lesions

  6. 2012 Provisional classification criteria for polymyalgia rheumatica

    Dasgupta, Bhaskar; Cimmino, Marco A; Kremers, Hilal Maradit

    2012-01-01

    The objective of this study was to develop European League Against Rheumatism/American College of Rheumatology classification criteria for polymyalgia rheumatica (PMR). Candidate criteria were evaluated in a 6-month prospective cohort study of 125 patients with new-onset PMR and 169 non-PMR compa...

  7. 2012 provisional classification criteria for polymyalgia rheumatica

    Dasgupta, Bhaskar; Cimmino, Marco A; Maradit-Kremers, Hilal

    2012-01-01

    The objective of this study was to develop EULAR/ACR classification criteria for polymyalgia rheumatica (PMR). Candidate criteria were evaluated in a 6-month prospective cohort study of 125 patients with new onset PMR and 169 non-PMR comparison subjects with conditions mimicking PMR. A scoring al...

  8. CT diagnostic criteria of branchial cysts

    Jend, H.H.; Jend-Rossmann, I.; Techentin, E.C.

    1984-01-01

    Although well known, the morphology of branchial cysts has not been sufficiently presented in CT literature. In the present case report, diagnostic criteria are given, such as typical site of occurrence, ductal extension towards the supratonsillar fossa, and cystic, but occasionally soft tissue density. Differential diagnosis is given for cases which cannot be classified according to these criteria. (orig.) [de

  9. CT diagnostic criteria of branchial cysts

    Jend, H.H.; Jend-Rossmann, I.; Techentin, E.C.

    1984-09-01

    Although well known, the morphology of branchial cysts has not been sufficiently presented in CT literature. In the present case report, diagnostic criteria are given, such as typical site of occurrence, ductal extension towards the supratonsillar fossa, and cystic, but occasionally soft tissue density. Differential diagnosis is given for cases which cannot be classified according to these criteria.

  10. Hybrid multiple criteria decision-making methods

    Zavadskas, Edmundas Kazimieras; Govindan, K.; Antucheviciene, Jurgita

    2016-01-01

    Formal decision-making methods can be used to help improve the overall sustainability of industries and organisations. Recently, there has been a great proliferation of works aggregating sustainability criteria by using diverse multiple criteria decision-making (MCDM) techniques. A number of revi...

  11. Education Criteria for Performance Excellence, 2002.

    National Inst. of Standards and Technology, Gaithersburg, MD.

    The education criteria presented in this guide are designed to help organizations use an integrated approach to organizational performance management that results in delivery of ever-improving value to students and stakeholders. Implementation of the criteria will contribute to improvement of education quality, improvement of overall…

  12. 42 CFR 456.5 - Evaluation criteria.

    2010-10-01

    ...) MEDICAL ASSISTANCE PROGRAMS UTILIZATION CONTROL General Provisions § 456.5 Evaluation criteria. The agency must establish and use written criteria for evaluating the appropriateness and quality of Medicaid services. This section does not apply to services in hospitals and mental hospitals. For these facilities...

  13. Multiple criteria facility location probems : a survey

    Farahani, R.Z.; Steadie Seifi, M.; Asgari, N.

    2010-01-01

    This paper provides a review on recent efforts and development in multi-criteria location problems in three categories including bi-objective, multi-objective and multi-attribute problems and their solution methods. Also, it provides an overview on various criteria used. While there are a few

  14. Aspirational Model Teaching Criteria for Psychology

    Richmond, Aaron S.; Boysen, Guy A.; Gurung, Regan A. R.; Tazeau, Yvette N.; Meyers, Steven A.; Sciutto, Mark J.

    2014-01-01

    In 2011, the Society for the Teaching of Psychology commissioned a presidential task force to document teaching criteria for model psychology teachers in undergraduate education. The resulting list of criteria reflects activities related to face-to-face course interaction and online teaching, training, and education; course design; implementation…

  15. Diagnostic criteria for DCD : Past and future

    Smits-Engelsman, Bouwien; Schoemaker, Marina; Delabastita, Tijs; Hoskens, Jasmine; Geuze, Reint

    The aim of this review was to gather information on how well authors comply to DSM criteria in their description and selection of children with DCD. We investigated which selection criteria were used in experimental and intervention studies published in the last 5 years (2010-2014). Results on 176

  16. 29 CFR 1904.4 - Recording criteria.

    2010-07-01

    ... criteria. (Needlestick and sharps injury cases, tuberculosis cases, hearing loss cases, medical removal... Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR RECORDING AND REPORTING OCCUPATIONAL INJURIES AND ILLNESSES Recordkeeping Forms and Recording Criteria § 1904.4...

  17. Models and criteria for waste repository performance

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

    1981-03-01

    A primary objective of the Waste Management Program is to assure that public health is protected. Predictive modeling, to some extent, will play a role in assuring that this objective is met. This paper considers the requirements and limitations of predictive modeling in providing useful inputs to waste management decision making. Criteria development needs and the relation between criteria and models are also discussed

  18. Learners' Epistemic Criteria for Good Scientific Models

    Pluta, William J.; Chinn, Clark A.; Duncan, Ravit Golan

    2011-01-01

    Epistemic criteria are the standards used to evaluate scientific products (e.g., models, evidence, arguments). In this study, we analyzed epistemic criteria for good models generated by 324 middle-school students. After evaluating a range of scientific models, but before extensive instruction or experience with model-based reasoning practices,…

  19. The validity of the Michigan Alcoholism Screening Test (MAST)

    Storgaard, H; Nielsen, S D; Gluud, C

    1994-01-01

    This review examines the validity of the Michigan Alcoholism Screening Test (MAST) as a screening instrument for alcohol problems. Studies that compare the MAST-questionnaire with other defined diagnostic criteria of alcohol problems were retrieved through MEDLINE and a cross-bibliographic check....... A total of 20 validity studies were included. The studies varied considerably regarding the prevalence of alcohol problems, the diagnostic criteria, and the examined patient categories. The MAST compared with other diagnostic criteria of alcohol problems gave validity measures with the following span...... and the specificities show substantial variations. The variables that seem to have the largest influence on the PVpos seem to be the prevalence of alcohol problems, the diagnostic method against which the MAST-questionnaire is validated, and the populations on which the MAST is applied. The MAST should in the future...

  20. Quality criteria for cardiac images: An update

    Bernardi, G.; Bar, O.; Jezewski, T.; Vano, E.; Maccia, C.; Trianni, A.; Padovani, R.

    2008-01-01

    The DIMOND II and III Cardiology Groups have agreed on quality criteria for cardiac images and developed a scoring system, to provide a tool to test quality of coronary angiograms, which was demonstrated to be of value in clinical practice. In the last years, digital flat panel technology has been introduced in cardiac angiographic systems and the radiological technique may have been influenced by the better performance of these new detectors. This advance in digital imaging, together with the lesson learned from previous studies, warranted the revision of the quality criteria for cardiac angiographic images as formerly defined. DIMOND criteria were reassessed to allow a simpler evaluation of angiograms. Clinical criteria were simplified and separated from technical criteria. Furthermore, the characteristics of an optimised angiographic technique have been outlined. (authors)

  1. An objective approach to determining criteria weights

    Milić R. Milićević

    2012-01-01

    Full Text Available This paper presents an objective approach to determining criteria weights that can be successfully used in multiple criteria models. The methods of entropy, CRITIC and FANMA are presented in this paper as well as a possible combination of the methods of objective and subjective approaches. Although based on different theoretical settings, and therefore with different algorithms of realization, all methods have a decision matrix as a starting point. An objective approach to determining the weight of criteria eliminates the negative impacts of a decision maker on criteria weights as well as on the final solution of multicriteria problems. The main aim of this paper is to systematize description procedures as a kind of help when encountering a problem of determining the criteria weights for solving multicriteria tasks. A possibility of the method application is shown in a numerical example.

  2. Nine Criteria for a Measure of Scientific Output

    Kreiman, Gabriel; Maunsell, John H. R.

    2011-01-01

    Scientific research produces new knowledge, technologies, and clinical treatments that can lead to enormous returns. Often, the path from basic research to new paradigms and direct impact on society takes time. Precise quantification of scientific output in the short-term is not an easy task but is critical for evaluating scientists, laboratories, departments, and institutions. While there have been attempts to quantifying scientific output, we argue that current methods are not ideal and suffer from solvable difficulties. Here we propose criteria that a metric should have to be considered a good index of scientific output. Specifically, we argue that such an index should be quantitative, based on robust data, rapidly updated and retrospective, presented with confidence intervals, normalized by number of contributors, career stage and discipline, impractical to manipulate, and focused on quality over quantity. Such an index should be validated through empirical testing. The purpose of quantitatively evaluating scientific output is not to replace careful, rigorous review by experts but rather to complement those efforts. Because it has the potential to greatly influence the efficiency of scientific research, we have a duty to reflect upon and implement novel and rigorous ways of evaluating scientific output. The criteria proposed here provide initial steps toward the systematic development and validation of a metric to evaluate scientific output. PMID:22102840

  3. Clinical and functional criteria for predicting asthma in infants

    Yu. L. Mizemitskiy

    2015-01-01

    Full Text Available Objective: to determine clinical and functional criteria for predicting asthma in children who have sustained acute obstructive bronchitis in infancy. Subjects and methods. A total of 125 infants aged 2 to 36 months who had experienced 1 -2 episodes of acute obstructive bronchitis and treated at hospital were examined when bronchial obstruction syndrome was being relieved. In addition to physical examination, functional studies (computerized bronchophonography and heart rate variability assessment were used. Immunological examination included determination of the serum levels of immunoglobulin E and interleuMn-17A. The infants who had sustained acute obstructive bronchitis were followed up for 12-36 months. Results. The infants who had sustained acute obstructive bronchitis in the presence of mild perinatal CNS damage caused by hypoxia were typified by high respiratory morbidity; early-onset bronchial obstruction; long-term bronchial obstruction relief; high incidence of grade 2 respiratory failure in acute obstructive bronchitis. These patients developed asthma more often than twice and repeated episodes of bronchial obstruction. ROC analysis was used to elaborate clinical and functional criteria for predicting the development of asthma in infants. Conclusion. The proposed additional clinical and functional criteria characterizing external respiratory dysfunction and autonomic homeostatic changes contribute to the early diagnosis of asthma and substantially increase the validity of prediction of its development in children younger than 3 years, which is of great importance for goal-oriented preventive measures.

  4. The DSM diagnostic criteria for gender identity disorder in children.

    Zucker, Kenneth J

    2010-04-01

    In this article, I review the diagnostic criteria for Gender Identity Disorder (GID) in children as they were formulated in the DSM-III, DSM-III-R, and DSM-IV. The article focuses on the cumulative evidence for diagnostic reliability and validity. It does not address the broader conceptual discussion regarding GID as "disorder," as this issue is addressed in a companion article by Meyer-Bahlburg (2009). This article addresses criticisms of the GID criteria for children which, in my view, can be addressed by extant empirical data. Based in part on reanalysis of data, I conclude that the persistent desire to be of the other gender should, in contrast to DSM-IV, be a necessary symptom for the diagnosis. If anything, this would result in a tightening of the diagnostic criteria and may result in a better separation of children with GID from children who display marked gender variance, but without the desire to be of the other gender.

  5. International consensus diagnostic criteria for neuromyelitis optica spectrum disorders

    Banwell, Brenda; Bennett, Jeffrey L.; Cabre, Philippe; Carroll, William; Chitnis, Tanuja; de Seze, Jérôme; Fujihara, Kazuo; Greenberg, Benjamin; Jacob, Anu; Jarius, Sven; Lana-Peixoto, Marco; Levy, Michael; Simon, Jack H.; Tenembaum, Silvia; Traboulsee, Anthony L.; Waters, Patrick; Wellik, Kay E.

    2015-01-01

    Neuromyelitis optica (NMO) is an inflammatory CNS syndrome distinct from multiple sclerosis (MS) that is associated with serum aquaporin-4 immunoglobulin G antibodies (AQP4-IgG). Prior NMO diagnostic criteria required optic nerve and spinal cord involvement but more restricted or more extensive CNS involvement may occur. The International Panel for NMO Diagnosis (IPND) was convened to develop revised diagnostic criteria using systematic literature reviews and electronic surveys to facilitate consensus. The new nomenclature defines the unifying term NMO spectrum disorders (NMOSD), which is stratified further by serologic testing (NMOSD with or without AQP4-IgG). The core clinical characteristics required for patients with NMOSD with AQP4-IgG include clinical syndromes or MRI findings related to optic nerve, spinal cord, area postrema, other brainstem, diencephalic, or cerebral presentations. More stringent clinical criteria, with additional neuroimaging findings, are required for diagnosis of NMOSD without AQP4-IgG or when serologic testing is unavailable. The IPND also proposed validation strategies and achieved consensus on pediatric NMOSD diagnosis and the concepts of monophasic NMOSD and opticospinal MS. PMID:26092914

  6. Criteria voor het beoordelen van tentamenuitwerkingen in het vak Programmeren [Assessment Criteria in Computer Programming Courses

    van den Berg, Klaas; van Diepen, N.M.; van Dijk, H.W.; Koppelman, Hermannus; Moerkerke, G.; Roossink, H.J.

    Bij het beoordelen is het belangrijk te weten welke criteria gehanteerd moeten worden. Met behulp van een vragenlijstonderzoek onder de docenten is een beperkt aantal criteria geselecteerd die gehanteerd moeten worden bij de cursus Inleiding in het Programmeren.

  7. Longitudinal diagnostic efficiency of DSM-IV criteria for obsessive-compulsive personality disorder: a 2-year prospective study.

    Grilo, C M; Skodol, A E; Gunderson, J G; Sanislow, C A; Stout, R L; Shea, M T; Morey, L C; Zanarini, M C; Bender, D S; Yen, S; McGlashan, T H

    2004-07-01

    To examine the longitudinal diagnostic efficiency of the DSM-IV criteria for obsessive-compulsive personality disorder (OCPD). At baseline, criteria and diagnoses were determined using diagnostic interviews, and blinded assessments were performed 24 months later with 550 participants. Diagnostic efficiency indices (conditional probabilities, total predictive power, and kappa) were calculated for each criterion determined at baseline, using the independent OCPD diagnosis at follow-up as the standard. Longitudinal diagnostic efficiencies for the OCPD criteria varied; findings suggested the overall predictive utility of 'preoccupied with details', 'rigid and stubborn', and 'reluctant to delegate'. These findings suggest the predictive validity of three cognitive-interpersonal OCPD criteria.

  8. To Make Good Decision: A Group DSS for Multiple Criteria Alternative Rank and Selection

    Chen-Shu Wang

    2015-01-01

    Full Text Available Decision making is a recursive process and usually involves multiple decision criteria. However, such multiple criteria decision making may have a problem in which partial decision criteria may conflict with each other. An information technology, such as the decision support system (DSS and group DSS (GDSS, emerges to assist decision maker for decision-making process. Both the DSS and GDSS should integrate with a symmetrical approach to assist decision maker to take all decision criteria into consideration simultaneously. This study proposes a GDSS architecture named hybrid decision-making support model (HDMSM and integrated four decision approaches (Delphi, DEMATEL, ANP, and MDS to help decision maker to rank and select appropriate alternatives. The HDMSM consists of five steps, namely, criteria identification, criteria correlation calculation, criteria evaluation, critical criteria selection, and alternative rank and comparison. Finally, to validate the proposed feasibility of the proposed model, this study also conducts a case study to find out the important indexes of corporate social responsibility (CSR from multiple perspectives. As the case study demonstrates the proposed HDMSM enables a group of decision makers to implement the MCDM effectively and help them to analyze the relation and degree of mutual influence among different evaluation factors.

  9. Proposed diagnosis criteria for inflicted head injury of children younger than two years of age

    Fujiwara, Takeo; Okuyama, Makiko; Matsumoto, Tsutomu; Aritaki, Kentarou; Yotani, Nobuyuki; Miyasaka, Mikiko; Nishina, Sachiko

    2008-01-01

    It is difficult to distinguish whether children's head injuries are due to physical abuse or unintentional accidents. However, in the literature, medical findings specific to infant physical abuse were identified. Thus, we developed diagnostic criteria for inflicted head injury (IHI) and assessed its validity. Subjects were collected from all patients who were less than two years old when they visited National Center for Child Health (NCCHD) and Development and underwent head CT scan to assess head trauma from March 1, 2002 to December 31, 2005. Diagnostic criteria for IHI were developed based on definitions of Duhaime et al (1992) and Reece et al (2001). Validity of diagnosis criteria was assessed by comparing the official report to the Child Guidance Center (CGC) from NCCHD to the disposition decided by the CGC. Two-hundred and sixty cases were collected and diagnosed. There was a 86.5% match of the number of cases which were diagnosed as IHI or non-IHI using the IHI diagnostic criteria with official reports to CGC from NCCHD. Among the cases which were diagnosed as presumptive IHI and also reported to the CGC, 20 cases (83.3%) were regarded as abused cases by the CGC. The diagnostic criteria for IHI were valid and would be useful for pediatricians not to condone inflicted head injury. (author)

  10. Redefining design criteria for Pu-238 gloveboxes

    Acosta, S.V.

    1998-01-01

    Enclosures for confinement of special nuclear materials (SNM) have evolved into the design of gloveboxes. During the early stages of glovebox technology, established practices and process operation requirements defined design criteria. Proven boxes that performed and met or exceeded process requirements in one group or area, often could not be duplicated in other areas or processes, and till achieve the same success. Changes in materials, fabrication and installation methods often only met immediate design criteria. Standardization of design criteria took a big step during creation of ''Special-Nuclear Materials R and D Laboratory Project, Glovebox standards''. The standards defined design criteria for every type of process equipment in its most general form. Los Alamos National Laboratory (LANL) then and now has had great success with Pu-238 processing. However with ever changing Environment Safety and Health (ES and H) requirements and Ta-55 Facility Configuration Management, current design criteria are forced to explore alternative methods of glovebox design fabrication and installation. Pu-238 fuel processing operations in the Power Source Technologies Group have pushed the limitations of current design criteria. More than half of Pu-238 gloveboxes are being retrofitted or replaced to perform the specific fuel process operations. Pu-238 glovebox design criteria are headed toward process designed single use glovebox and supporting line gloveboxes. Gloveboxes that will house equipment and processes will support TA-55 Pu-238 fuel processing needs into the next century and extend glovebox expected design life

  11. Dynamic criteria for partitioning and transmutation

    Lu, A.H.

    1991-11-01

    This paper addresses dynamic criteria intended to optimize partitioning and transmutation (P-T) concept development supporting improved nuclear waste management. Six criteria are proposed initially and the rationale for each is briefly explained. Each criterion is used as a measure (or dimension) on which the developed concepts can be evaluated. The criteria allow the P-T concepts to be evaluated in an integral system including long-term energy needs, fuel cycle, and waste management. New criteria will be identified along with the P-T concept development, and each criterion will be realistically weighted so that it is comparable in an overall criteria evaluation. The weights are subject to change as a result of technical advancements and public perception on various issues. Incomplete criteria will result in a poor choice because important factors may not be considered when the decision is made. A successful decision on the optimal P-T system depends on the completeness of criteria (dimensions) as well as realistic weights assigned to each criterion

  12. Broad versus narrow traits: Conscientiousness and Honesty-Humility as predictors of academic criteria

    de Vries, A.; de Vries, R.E.; Born, M.Ph.

    2011-01-01

    Recent research has suggested that the six-dimensional personality model, and especially the dimension Honesty-Humility/Integrity, adds incremental validity to the prediction of important criteria. We expected both this dimension and the dimension Conscientiousness to explain incremental variance in

  13. Guidelines, Criteria, and Rules of Thumb for Evaluating Normed and Standardized Assessment Instruments in Psychology.

    Cicchetti, Domenic V.

    1994-01-01

    In the context of developing assessment instruments in psychology, issues of standardization, norming procedures, and test reliability and validity are discussed. Criteria, guidelines, and rules of thumb are provided to help the clinician with instrument selection for a given psychological assessment. (SLD)

  14. Guidance for the definition and application of probabilistic safety criteria

    Holmberg, J.-E.; Knochenhauer, M.

    2011-05-01

    The project 'The Validity of Safety Goals' has been financed jointly by NKS (Nordic Nuclear Safety Research), SSM (Swedish Radiation Safety Authority) and the Swedish and Finnish nuclear utilities. The national financing went through NPSAG, the Nordic PSA Group (Swedish contributions) and SAFIR2010, the Finnish research programme on NPP safety (Finnish contributions). The project has been performed in four phases during 2006-2010. This guidance document aims at describing, on the basis of the work performed throughout the project, issues to consider when defining, applying and interpreting probabilistic safety criteria. Thus, the basic aim of the document is to serve as a checklist and toolbox for the definition and application of probabilistic safety criteria. The document describes the terminology and concepts involved, the levels of criteria and relations between these, how to define a probabilistic safety criterion, how to apply a probabilistic safety criterion, on what to apply the probabilistic safety criterion, and how to interpret the result of the application. The document specifically deals with what makes up a probabilistic safety criterion, i.e., the risk metric, the frequency criterion, the PSA used for assessing compliance and the application procedure for the criterion. It also discusses the concept of subsidiary criteria, i.e., different levels of safety goals. The results from the project can be used as a platform for discussions at the utilities on how to define and use quantitative safety goals. The results can also be used by safety authorities as a reference for risk-informed regulation. The outcome can have an impact on the requirements on PSA, e.g., regarding quality, scope, level of detail, and documentation. Finally, the results can be expected to support on-going activities concerning risk-informed applications. (Author)

  15. AAPT Diagnostic Criteria for Chronic Cancer Pain Conditions.

    Paice, Judith A; Mulvey, Matt; Bennett, Michael; Dougherty, Patrick M; Farrar, John T; Mantyh, Patrick W; Miaskowski, Christine; Schmidt, Brian; Smith, Thomas J

    2017-03-01

    Chronic cancer pain is a serious complication of malignancy or its treatment. Currently, no comprehensive, universally accepted cancer pain classification system exists. Clarity in classification of common cancer pain syndromes would improve clinical assessment and management. Moreover, an evidence-based taxonomy would enhance cancer pain research efforts by providing consistent diagnostic criteria, ensuring comparability across clinical trials. As part of a collaborative effort between the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) and the American Pain Society (APS), the ACTTION-APS Pain Taxonomy initiative worked to develop the characteristics of an optimal diagnostic system. After the establishment of these characteristics, a working group consisting of clinicians and clinical and basic scientists with expertise in cancer and cancer-related pain was convened to generate core diagnostic criteria for an illustrative sample of 3 chronic pain syndromes associated with cancer (ie, bone pain and pancreatic cancer pain as models of pain related to a tumor) or its treatment (ie, chemotherapy-induced peripheral neuropathy). A systematic review and synthesis was conducted to provide evidence for the dimensions that comprise this cancer pain taxonomy. Future efforts will subject these diagnostic categories and criteria to systematic empirical evaluation of their feasibility, reliability, and validity and extension to other cancer-related pain syndromes. The ACTTION-APS chronic cancer pain taxonomy provides an evidence-based classification for 3 prevalent syndromes, namely malignant bone pain, pancreatic cancer pain, and chemotherapy-induced peripheral neuropathy. This taxonomy provides consistent diagnostic criteria, common features, comorbidities, consequences, and putative mechanisms for these potentially serious cancer pain conditions that can be extended and applied with other cancer

  16. Guidance for the definition and application of probabilistic safety criteria

    Holmberg, J.-E. (VTT Technical Research Centre of Finland (Finland)); Knochenhauer, M. (Scandpower AB (Sweden))

    2011-05-15

    The project 'The Validity of Safety Goals' has been financed jointly by NKS (Nordic Nuclear Safety Research), SSM (Swedish Radiation Safety Authority) and the Swedish and Finnish nuclear utilities. The national financing went through NPSAG, the Nordic PSA Group (Swedish contributions) and SAFIR2010, the Finnish research programme on NPP safety (Finnish contributions). The project has been performed in four phases during 2006-2010. This guidance document aims at describing, on the basis of the work performed throughout the project, issues to consider when defining, applying and interpreting probabilistic safety criteria. Thus, the basic aim of the document is to serve as a checklist and toolbox for the definition and application of probabilistic safety criteria. The document describes the terminology and concepts involved, the levels of criteria and relations between these, how to define a probabilistic safety criterion, how to apply a probabilistic safety criterion, on what to apply the probabilistic safety criterion, and how to interpret the result of the application. The document specifically deals with what makes up a probabilistic safety criterion, i.e., the risk metric, the frequency criterion, the PSA used for assessing compliance and the application procedure for the criterion. It also discusses the concept of subsidiary criteria, i.e., different levels of safety goals. The results from the project can be used as a platform for discussions at the utilities on how to define and use quantitative safety goals. The results can also be used by safety authorities as a reference for risk-informed regulation. The outcome can have an impact on the requirements on PSA, e.g., regarding quality, scope, level of detail, and documentation. Finally, the results can be expected to support on-going activities concerning risk-informed applications. (Author)

  17. Simplified Stability Criteria for Delayed Neutral Systems

    Xinghua Zhang

    2014-01-01

    Full Text Available For a class of linear time-invariant neutral systems with neutral and discrete constant delays, several existing asymptotic stability criteria in the form of linear matrix inequalities (LMIs are simplified by using matrix analysis techniques. Compared with the original stability criteria, the simplified ones include fewer LMI variables, which can obviously reduce computational complexity. Simultaneously, it is theoretically shown that the simplified stability criteria and original ones are equivalent; that is, they have the same conservativeness. Finally, a numerical example is employed to verify the theoretic results investigated in this paper.

  18. Modern dimensioning criteria for pressure vessels

    Roche, Roland.

    1975-01-01

    Some ideas on modern dimensioning criteria are given and their advantages with regard to both safety and economy are shown. In general these criteria result from considerations on possible damage to the apparatus in service and the modes of breakdown liable to follow. They are general enough to allow for a variety of dimensioning methods both experimental and theoretical, with special reference to modern computerized digital analysis techniques. As a practical example however some notions are given on the simplest means of computing dimensions in accordance with these criteria [fr

  19. Containment penetration design criteria and implementation

    Perry, R.F.; Rigamonti, G.; Dainora, J.

    1975-01-01

    A rational design criteria is presented which serves as a basis for the design and analysis of containment piping penetrations. The criteria includes the effect of temperature as well as mechanical loads for the full range of plant conditions. With this criteria various penetration flued head designs have been compared and optimization achieved. Sleeve wall dimensions and containment loads have been determined without reference to piping configuration. An interaction theory which allows the implementation of the criteria for the determination of design loads and minimum sleeve wall thickness. The interaction theory developed applies to elastic-perfectly plastic cylinders (pipes and sleeves) and accounts for the simultaneous load resultants of transverse shear force, bending moment, torsional moment, and axial force in addition to internal pipe pressure. Application of the theory developed to the determination of sleeve thickness and containment design loads is presented in detail. (Auth.)

  20. Infill sampling criteria to locate extremes

    Watson, AG

    1995-07-01

    Full Text Available Three problem-dependent meanings for engineering ''extremes'' are motivated, established, and translated into formal geostatistical (model-based) criteria for designing infill sample networks. (I) Locate an area within the domain of interest where a...

  1. Safety criteria of uranium enrichment plants

    Nardocci, A.C.; Oliveira Neto, J.M. de

    1994-01-01

    The applicability of nuclear reactor safety criteria applied to uranium enrichment plants is discussed, and a new criterion based on the soluble uranium compounds and hexafluoride chemical toxicities is presented. (L.C.J.A.). 21 refs, 4 tabs

  2. SEISMIC DESIGN CRITERIA FOR NUCLEAR POWER REACTORS

    Williamson, R. A.

    1963-10-15

    The nature of nuclear power reactors demands an exceptionally high degree of seismic integrity. Considerations involved in defining earthquake resistance requirements are discussed. Examples of seismic design criteria and applications of the spectrum technique are described. (auth)

  3. 45 CFR 1801.21 - Evaluation criteria.

    2010-10-01

    ... HARRY S. TRUMAN SCHOLARSHIP PROGRAM The Competition § 1801.21 Evaluation criteria. (a) The Foundation...: (1) Extent and quality of community service and government involvement; (2) Leadership record; (3...

  4. Ebook Evaluation Criteria: A Proposed Checklist

    Amir Ghaebi

    2010-09-01

    Full Text Available E-books embody diverse features, each of which could contribute towards increasing their user-agreeability and attracting more users. In order to select an Ebook best suited to their needs, both users and librarians consider a set of criteria. The present study aims at providing the evaluation criteria from the standpoint of both the users and librarys by employing two approaches, i.e. through considering the characteristics of the electronic environment, and also maintaining the desired features of the printed media in E-books. By reviewing the resources published in the field of E-books, 15 criteria along with 101 components have been collectively discussed for evaluation of the suitable E-book for users and libraries. Four criteria with 24 components have been solely devised for libraries and librarians.

  5. ACR Appropriateness Criteria on Resectable Rectal Cancer

    Suh, W. Warren; Blackstock, A. William; Herman, Joseph; Konski, Andre A.; Mohiuddin, Mohammed; Poggi, Matthew M.; Regine, William F.; Cosman, Bard C.; Saltz, Leonard; Johnstone, Peter A.S.

    2008-01-01

    The American College of Radiology (ACR) Appropriateness Criteria on Resectable Rectal Cancer was updated by the Expert Panel on Radiation Oncology-Rectal/Anal Cancer, based on a literature review completed in 2007

  6. Retinopathy of prematurity screening criteria and workload ...

    Larger infants require screening to include a few outliers, but they ... Making local screening criteria narrower on the basis of a limited evidence base may be dangerous. Risk factors for CSROP in larger infants need to be researched.

  7. Retinopathy of prematurity screening criteria and workload ...

    Larger infants require screening to include a few outliers, but they require ... Making local screening criteria narrower on the basis of a limited evidence base may be dangerous. Risk factors for CSROP in larger infants need to be researched.

  8. Sgarbossa criteria and acute myocardial infarction.

    Alang, Neha; Bathina, Jaya; Kranis, Mark; Angelis, Dimitrios

    2010-01-01

    Diagnosis of acute ST-elevation myocardial infarction in the presence of left bundle branch block is difficult. present a case of acute myocardial infarction with LBBB diagnosed and treated using the Sgarbossa criteria.

  9. 16 CFR 1031.12 - Membership criteria.

    2010-01-01

    ... Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION GENERAL COMMISSION PARTICIPATION AND COMMISSION EMPLOYEE INVOLVEMENT IN VOLUNTARY STANDARDS ACTIVITIES Employee Involvement § 1031.12 Membership criteria. (a) The Commissioners, their special assistants, and Commission officials and employees holding the...

  10. 16 CFR 1031.14 - Observation criteria.

    2010-01-01

    ....14 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION GENERAL COMMISSION PARTICIPATION AND COMMISSION EMPLOYEE INVOLVEMENT IN VOLUNTARY STANDARDS ACTIVITIES Employee Involvement § 1031.14 Observation criteria. A Commission official or employee may, on occasion, attend voluntary standards meetings for the...

  11. Design criteria monograph for pressurized metal cases

    1972-01-01

    Organiation and presentation of data pertaining to design of solid propellant rocket engine cases are discussed. Design criteria are presented in form of monograph based on accumulated experience and knowledge. Improvements in reliability, cost effectiveness, and engine efficiency are stressed.

  12. Generalized Lawson Criteria for Inertial Confinement Fusion

    Tipton, Robert E. [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States)

    2015-08-27

    The Lawson Criterion was proposed by John D. Lawson in 1955 as a general measure of the conditions necessary for a magnetic fusion device to reach thermonuclear ignition. Over the years, similar ignition criteria have been proposed which would be suitable for Inertial Confinement Fusion (ICF) designs. This paper will compare and contrast several ICF ignition criteria based on Lawson’s original ideas. Both analytical and numerical results will be presented which will demonstrate that although the various criteria differ in some details, they are closely related and perform similarly as ignition criteria. A simple approximation will also be presented which allows the inference of each ignition parameter directly from the measured data taken on most shots fired at the National Ignition Facility (NIF) with a minimum reliance on computer simulations. Evidence will be presented which indicates that the experimentally inferred ignition parameters on the best NIF shots are very close to the ignition threshold.

  13. Models and criteria for LLW disposal performance

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

    1980-12-01

    A primary objective of the Low Level Waste (LLW) Management Program is to assure that public health is protected. Predictive modeling, to some extent, will play a role in meeting this objective. This paper considers the requirements and limitations of predictive modeling in providing useful inputs to waste mangement decision making. In addition, criteria development needs and the relation between criteria and models are discussed

  14. Application of trial risk acceptance criteria

    Johnson, D.H.; Kastenberg, W.E.; Okrent, D.

    1982-01-01

    The objective of this paper is to investigate some of the implications inherent in the application of various proposed sets of risk acceptance criteria. A power-law model of risk aversion is utilized to estimate the equivalent number of individual deaths and is treated parametrically. The implications of ALARA requirements for cost-effective improvements are also illustrated. The risks assessed for various technological endeavors, as well as some estimated natural background risks, are compared to the trial criteria

  15. Strain limit criteria to predict failure

    Flanders, H.E.

    1995-01-01

    In recent years extensive effort has been expended to qualify existing structures for conditions that are beyond the original design basis. Determination of the component failure load is useful for this type of evaluation. This paper presents criteria based upon strain limits to predict the load at failure. The failure modes addressed are excessive plastic deformations, localized plastic strains, and structural instability. The effects of analytical method sophistication, as built configurations, material properties degradation, and stress state are addressed by the criteria

  16. Extended BRS algebra and color confinement criteria

    Shintani, Meiun.

    1983-09-01

    We examine the color-confinement criteria proposed by Kugo and Ojima. With the use of the extended BRS symmetry and the Nakanishi's theorem, we look for the representations of the BRS algebra compatible with the first condition of their criteria (the K-O condition) and then ask whether or not they are physically acceptable. As a result, the quartet mechanism does not work, and the K-O condition is not regarded as a confinement condition. (author)

  17. TAPS safety evaluation criteria for reload fueling

    Mahendra Nath; Veeraraghavan, N.

    1976-01-01

    To improve operating performance of Tarapur reactors, several proposals are under consideration such as core expansion, change-over to an improved fuel design with lower heat rating, extension of fuel cycle lengths etc., which have a bearing on overall plant operating characteristics and reactor safety. For evaluating safety implications of the various proposals, it is necessary to formulate safety evaluation criteria for reload fuelling. Salient features of these criteria are discussed. (author)

  18. Choice Criteria of Cosmetics among Chinese Consumers

    LI, ZHU

    2014-01-01

    Becoming familiar with consumers’ choice criteria towards a certain kind of product can help marketers tailor more efficient market strategies. Cosmetics play a very important part in the lives of women. Plautus asserted, “A woman without paint is like food without salt”. In recent years, the Chinese cosmetic market has flourished. The aim of this dissertation is to understand the choice criteria of cosmetics in the context of the Chinese market. Country-of-origin, brand image and quality are...

  19. Models and criteria for LLW disposal performance

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

    1980-01-01

    A primary objective of the Low Level Waste (LLW) Management Program is to assure that public health is protected. Predictive modeling, to some extent, will play a role in meeting this objective. This paper considers the requirements and limitations of predictive modeling in providing useful inputs to waste management decision making. In addition, criteria development needs and the relation between criteria and models are discussed

  20. When Progressive Disease Does Not Mean Treatment Failure: Reconsidering the Criteria for Progression

    2012-01-01

    Although progression-based endpoints, such as progression-free survival, are often key clinical trial endpoints for anticancer agents, the clinical meaning of “objective progression” is much less certain. As scrutiny of progression-based endpoints in clinical trials increases, it should be remembered that the Response Evaluation Criteria In Solid Tumors (RECIST) progression criteria were not developed as a surrogate for survival. Now that progression-free survival has come to be an increasingly important trial endpoint, the criteria that define progression deserve critical evaluation to determine whether alternate definitions of progression might facilitate the development of stronger surrogate endpoints and more meaningful trial results. In this commentary, we review the genesis of the criteria for progression, highlight recent data that question their value as a marker of treatment failure, and advocate for several research strategies that could lay the groundwork for a clinically validated definition of disease progression in solid tumor oncology. PMID:22927506

  1. [Reflections about the efficiency criteria for cancer treatments during marketing authorization application].

    Jeannin, Noémie; Blois-Da Conceição, Stéphanie; Protière, Christel

    2013-03-01

    Although clear and validated recommendations exist concerning the evaluation of cancer treatments at the international level, the criteria retained to obtain the marketing authorization (MA) are multiple and heterogeneous. This qualitative survey explores the opinion related to the assessment of cancer treatment among the several concerned population. By the way of semi-structured interviews, our aim was to elicit perceptions toward the criteria which should be retained during the process of MA, by patients, oncologists, members of the pharmaceutical industry, health decision-makers and general population. Our survey emphasizes the variability of the significations associated with the criteria of efficiency of cancer treatments according to the characteristics of the respondents. We also have observed some common expectations from patients and oncologists toward the economic and political aspect, but also from the whole respondents toward the importance of the comfort of the patients. Lastly, the necessity to define specific criteria related to clinical cases emerges.

  2. Risk assessment of soil contamination criteria

    King, C.M.; Marter, W.L.; Montaque, D.F.; Holton, G.A.

    1987-06-01

    Criteria have been developed to select radioactive and nonradioactive contaminants at waste sites detailed analysis and risk assessment. These criteria were based on soil and water quality guidelines developed by various government agencies to determine if the criteria were appropriate. We performed a risk assessment of a hypothetical site which contained radioactive and nonradioactive contaminants at levels equal to the criteria values. Risks to the public from atmospheric, surface water, and groundwater exposure pathways were examined. Health risks to the public from atmospheric releases of radioactive and nonradioactive materials from a waste at soil criteria contamination levels are low. Health risks to the maximally exposed individual to chemical carcinogens are considerably below traditional EPA action levels. And health risks to the maximally exposed individual to atmospherically released radioactive contaminants is 1.88 x 10 -7 , more than a factor of 5 less than 10 -6 . Based on our atmospheric exposure pathways analysis and risk assessment, the applied soil criteria are appropriate for screening out unimportant risk contributors to human health from atmospheric exposure pathways. 13 refs., 3 figs., 7 tabs

  3. Fast evaluation of 69 basal cell carcinomas with ex vivo fluorescence confocal microscopy: criteria description, histopathological correlation, and interobserver agreement.

    Bennàssar, Antoni; Carrera, Cristina; Puig, Susana; Vilalta, Antoni; Malvehy, Josep

    2013-07-01

    Fluorescence confocal microscopy (FCM) represents a first step toward a rapid "bedside pathology" in the Mohs surgery setting and in other fields of general pathology. To describe and validate FCM criteria for the main basal cell carcinoma (BCC) subtypes and to demonstrate the overall agreement with classic pathologic analysis of hematoxylin-eosin-stained samples. DESIGN A total of 69 BCCs from 66 patients were prospectively imaged using ex vivo FCM. Confocal mosaics were evaluated in real time and compared with classic pathologic analysis. Department of Dermatology, Hospital Clínic of Barcelona, Barcelona, Spain, between November 2010 and July 2011. Patients with BCC attending the Mohs Surgery Unit. Presence or absence of BCC and histological subtype (superficial, nodular, and infiltrating) in the confocal mosaics. Eight criteria for BCC were described, evaluated, and validated. Although there were minor differences among BCC subtypes, the most BCC-defining criteria were peripheral palisading, clefting, nuclear pleomorphism, and presence of stroma. These criteria were validated with independent observers (κ values >0.7 [corrected] for most criteria). We herein propose, describe, and validate FCM criteria for BCC diagnosis. Fluorescence confocal microscopy is an attractive alternative to histopathologic analysis of frozen sections during Mohs surgery because large areas of freshly excised tissue can be assessed in real time without the need for tissue processing while minimizing labor and costs.

  4. Ethical Implications of Validity-vs.-Reliability Trade-Offs in Educational Research

    Fendler, Lynn

    2016-01-01

    In educational research that calls itself empirical, the relationship between validity and reliability is that of trade-off: the stronger the bases for validity, the weaker the bases for reliability (and vice versa). Validity and reliability are widely regarded as basic criteria for evaluating research; however, there are ethical implications of…

  5. Technological Criteria Technology-Environmental under a Systemic Approach: Chemistry Technology Transfer

    Durán-García Martín Enrique

    2014-07-01

    Full Text Available Currently the transfer of chemical technology is a process that contributes to the technology policy of a country, an industry or an organization in general chemistry. This process requires the application of clear criteria for the proper development of the complex interrelations in the transfer of chemical technology. A group of criteria that are present, are those related to environmental technology which intrinsically define the technology and its impact to the environment. Therefore, the transfer of chemical technology requires technological-environmental criteria defining, in conjunction with other criteria, an adequate process for the selection, acquisition and incorporation of technology in a holistic perspective, so it provides feasible solutions the chemical industry in pursuit of their goals. Then the criterion becomes a benchmark for assessing an appropriate technology transfer process. We performed a theoretical analysis of the technological and environmental criteria, proposing thirty-six (36 technological-environmental criteria interrelated under a systemic approach in the process of transfer of chemical technology, focused on a methodological cycle first run, based primarily on the research-action method. Future research is expected to make a refinement of the criteria from the formulation and validation of metrics so that necessary adjustments are made to optimize the process of transfer of chemical technology.

  6. Criteria for quantitative and qualitative data integration: mixed-methods research methodology.

    Lee, Seonah; Smith, Carrol A M

    2012-05-01

    Many studies have emphasized the need and importance of a mixed-methods approach for evaluation of clinical information systems. However, those studies had no criteria to guide integration of multiple data sets. Integrating different data sets serves to actualize the paradigm that a mixed-methods approach argues; thus, we require criteria that provide the right direction to integrate quantitative and qualitative data. The first author used a set of criteria organized from a literature search for integration of multiple data sets from mixed-methods research. The purpose of this article was to reorganize the identified criteria. Through critical appraisal of the reasons for designing mixed-methods research, three criteria resulted: validation, complementarity, and discrepancy. In applying the criteria to empirical data of a previous mixed methods study, integration of quantitative and qualitative data was achieved in a systematic manner. It helped us obtain a better organized understanding of the results. The criteria of this article offer the potential to produce insightful analyses of mixed-methods evaluations of health information systems.

  7. Validation of psychoanalytic theories: towards a conceptualization of references.

    Zachrisson, Anders; Zachrisson, Henrik Daae

    2005-10-01

    The authors discuss criteria for the validation of psychoanalytic theories and develop a heuristic and normative model of the references needed for this. Their core question in this paper is: can psychoanalytic theories be validated exclusively from within psychoanalytic theory (internal validation), or are references to sources of knowledge other than psychoanalysis also necessary (external validation)? They discuss aspects of the classic truth criteria correspondence and coherence, both from the point of view of contemporary psychoanalysis and of contemporary philosophy of science. The authors present arguments for both external and internal validation. Internal validation has to deal with the problems of subjectivity of observations and circularity of reasoning, external validation with the problem of relevance. They recommend a critical attitude towards psychoanalytic theories, which, by carefully scrutinizing weak points and invalidating observations in the theories, reduces the risk of wishful thinking. The authors conclude by sketching a heuristic model of validation. This model combines correspondence and coherence with internal and external validation into a four-leaf model for references for the process of validating psychoanalytic theories.

  8. Photovoltaic system criteria documents. Volume 3: Environmental issues and evaluation criteria for photovoltaic applications

    Koenig, John C.; Billitti, Joseph W.; Tallon, John M.

    1979-01-01

    The environmental issues and evaluation criteria relating to the suitability of sites proposed for photovoltaic (PV) system deployment are identified. The important issues are defined, briefly discussed and then developed into evaluation criteria. System designers are provided with information on the environmental sensitivity of PV systems in realistic applications, background material which indicates the applicability of the siting issues identified, and evaluation criteria are defined to facilitate the selection of sites that maximize PV system operation.

  9. Method validation in pharmaceutical analysis: from theory to practical optimization

    Jaqueline Kaleian Eserian

    2015-01-01

    Full Text Available The validation of analytical methods is required to obtain high-quality data. For the pharmaceutical industry, method validation is crucial to ensure the product quality as regards both therapeutic efficacy and patient safety. The most critical step in validating a method is to establish a protocol containing well-defined procedures and criteria. A well planned and organized protocol, such as the one proposed in this paper, results in a rapid and concise method validation procedure for quantitative high performance liquid chromatography (HPLC analysis.   Type: Commentary

  10. The Criteria for Determining the Business Failure

    Luminiţa TULEAŞCĂ

    2012-03-01

    Full Text Available The business failure represents a current problem in any economic and social context and, for this reason, the legislator has been concerned with the regulation of the criteria based on which to accurately determine the failure of a business man when the case. The liquidity test and the balance sheet test, or the insolvency and insolvability are the criteria for determining the business failure usually materialized by undergoing the bankruptcy procedure. The legislator’s option for one or another of these criteria represents a structural option depending on the legal culture of each state however, considering the economic causes and effects of the insolvability and insolvency, that tends to remove the unilateral, exclusivist options. This paper illustrates significant option differences between the criteria for determining the business failure in the member states of the European Union which is the most used criterion and, if these criteria can be equally used in the banking and insurance sector. Last but not least, the paper illustrates the meanings of insolvency and insolvability in different matters and different laws and the need to eliminate the reserve that the Romanian doctrine manifests towards the insolvability concept as a cause for bankruptcy.

  11. Rationales for the Lightning Launch Commit Criteria

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

    2016-01-01

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

  12. DOE Standard: Fire protection design criteria

    1999-07-01

    The development of this Standard reflects the fact that national consensus standards and other design criteria do not comprehensively or, in some cases, adequately address fire protection issues at DOE facilities. This Standard provides supplemental fire protection guidance applicable to the design and construction of DOE facilities and site features (such as water distribution systems) that are also provided for fire protection. It is intended to be used in conjunction with the applicable building code, National Fire Protection Association (NFPA) Codes and Standards, and any other applicable DOE construction criteria. This Standard replaces certain mandatory fire protection requirements that were formerly in DOE 5480.7A, ''Fire Protection'', and DOE 6430.1A, ''General Design Criteria''. It also contains the fire protection guidelines from two (now canceled) draft standards: ''Glove Box Fire Protection'' and ''Filter Plenum Fire Protection''. (Note: This Standard does not supersede the requirements of DOE 5480.7A and DOE 6430.1A where these DOE Orders are currently applicable under existing contracts.) This Standard, along with the criteria delineated in Section 3, constitutes the basic criteria for satisfying DOE fire and life safety objectives for the design and construction or renovation of DOE facilities

  13. On melting criteria for complex plasma

    Klumov, Boris A

    2011-01-01

    The present paper considers melting criteria for a plasma crystal discovered in dust plasma in 1994. Separate discussions are devoted to three-dimensional (3D) and two-dimensional (2D) systems. In the 3D case, melting criteria are derived based on the properties of local order in a system of microparticles. The order parameters are constructed from the cumulative distributions of the microparticle probability distributions as functions of various rotational invariants. The melting criteria proposed are constructed using static information on microparticle positions: a few snapshots of the system that allow for the determination of particle coordinates are enough to determine the phase state of the system. It is shown that criteria obtained in this way describe well the melting and premelting of 3D complex plasmas. In 2D systems, a system of microparticles interacting via a screened Coulomb (i.e., Debye-Hueckel or Yukawa) potential is considered as an example, using molecular dynamics simulations. A number of new order parameters characterizing the melting of 2D complex plasmas are proposed. The order parameters and melting criteria proposed for 2D and 3D complex plasmas can be applied to other systems as well. (methodological notes)

  14. Developing a New Definition and Assessing New Clinical Criteria for Septic Shock For the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3)

    Shankar-Hari, Manu; Phillips, Gary S.; Levy, Mitchell L.; Seymour, Christopher W.; Liu, Vincent X.; Deutschman, Clifford S.; Angus, Derek C.; Rubenfeld, Gordon D.; Singer, Mervyn; Angus, Derek; Annane, Djilalli; Bauer, Michael; Bellomo, Rinaldo; Bernard, Gordon; Chiche, Jean-Daniel; Coopersmith, Craig; Deutschman, Cliff; Hotchkiss, Richard; Levy, Mitchell; Marshall, John; Martin, Greg; Opal, Steve; Rubenfeld, Gordon; Seymour, Christopher; van der Poll, Tom; Vincent, Jean-Louis

    2016-01-01

    IMPORTANCE Septic shock currently refers to a state of acute circulatory failure associated with infection. Emerging biological insights and reported variation in epidemiology challenge the validity of this definition. OBJECTIVE To develop a new definition and clinical criteria for identifying

  15. Plugging criteria for WWER SG tubes

    Papp, L.; Wilam, M. [Vitkovice NPP Services (Switzerland); Herman, M. [Vuje, Trnava (Slovakia)

    1997-12-31

    At operated Czech and Slovak nuclear power plants the 80 % criteria for crack or other bulk defect depth is used for steam generator heat exchanging tubes plugging. This criteria was accepted as the recommendation of designer of WWER steam generators. Verification of this criteria was the objective of experimental program performed by Vitkovice, J.S.C., UJV Rez, J.S.C. and Vuje Trnava, J.S.C .. Within this program the following factors were studied: (1) Influence of secondary water chemistry on defects initiation and propagation, (2) Statistical evaluation of corrosion defects progression at operated SG, and (3) Determination of critical pressure for tube rupture as a function of eddy current indications. In this presentation items (2) and (3) are considered.

  16. Nonreactor nuclear facilities: standards and criteria guide

    Brynda, W.J.; Junker, L.; Karol, R.C.; Lobner, P.R.; Goldman, L.A.

    1981-09-01

    This guide is a source document that identifies standards, codes, and guides that address the nuclear safety considerations pertinent to nuclear facilities as defined in DOE Order 5480.1, Chapter V, Safety of Nuclear Facilities. The guidance and criteria provided are directed toward areas of safety usually addressed in a Safety Analysis Report. The areas of safety include, but are not limited to, siting, principal design criteria and safety system design guidelines, radiation protection, accident analysis, and quality assurance. The guide is divided into two sections: general guidelines and appendices. Those guidelines that are broadly applicable to most nuclear facilities are presented in the general guidelines. These general guidelines may have limited applicability to subsurface facilities such as waste repositories. Guidelines specific to the various types or categories of nuclear facilities are presented in the appendices. These facility-specific appendices provide guidelines and identify standards and criteria that should be considered in addition to, or in lieu of, the general guidelines

  17. Nonreactor nuclear facilities: Standards and criteria guide

    Brynda, W.J.; Scarlett, C.H.; Tanguay, G.E.; Lobner, P.R.

    1986-09-01

    This guide is a source document that identifies standards, codes, and guides that address the nuclear safety considerations pertinent to nuclear facilities as defined in DOE 5480.1A, Chapter V, ''Safety of Nuclear Facilities.'' The guidance and criteria provided is directed toward areas of safety usually addressed in a Safety Analysis Report. The areas of safety include, but are not limited to, siting, principal design criteria and safety system design guidelines, radiation protection, accident analysis, conduct of operations, and quality assurance. The guide is divided into two sections: general guidelines and appendices. Those guidelines that are broadly applicable to most nuclear facilities are presented in the general guidelines. Guidelines specific to the various types or categories of nuclear facilities are presented in the appendices. These facility-specific appendices provide guidelines and identify standards and criteria that should be considered in addition to, or in lieu of, the general guidelines. 25 figs., 62 tabs

  18. Plugging criteria for WWER SG tubes

    Papp, L; Wilam, M [Vitkovice NPP Services (Switzerland); Herman, M [Vuje, Trnava (Slovakia)

    1998-12-31

    At operated Czech and Slovak nuclear power plants the 80 % criteria for crack or other bulk defect depth is used for steam generator heat exchanging tubes plugging. This criteria was accepted as the recommendation of designer of WWER steam generators. Verification of this criteria was the objective of experimental program performed by Vitkovice, J.S.C., UJV Rez, J.S.C. and Vuje Trnava, J.S.C .. Within this program the following factors were studied: (1) Influence of secondary water chemistry on defects initiation and propagation, (2) Statistical evaluation of corrosion defects progression at operated SG, and (3) Determination of critical pressure for tube rupture as a function of eddy current indications. In this presentation items (2) and (3) are considered.

  19. Maintenance evaluation using risk based criteria

    Torres Valle, A.

    1996-01-01

    The maintenance evaluation is currently performed by using economic and, in some case, technical equipment failure criteria, however this is done to a specific equipment level. In general, when statistics are used the analysis for maintenance optimization are made isolated and whit a post mortem character; The integration provided by mean of Probabilistic Safety assessment (PSA) together with the possibilities of its applications, allow for evaluation of maintenance on the basis of broader scope criteria in regard to those traditionally used. The evaluate maintenance using risk based criteria, is necessary to follow a dynamic and systematic approach, in studying the maintenance strategy, to allow for updating the initial probabilistic models, for including operational changes that often take place during operation of complex facilities. This paper proposes a dynamic evaluation system of maintenance task. The system is illustrated by means of a practical example

  20. Developing criteria to establish Trusted Digital Repositories

    Faundeen, John L.

    2017-01-01

    This paper details the drivers, methods, and outcomes of the U.S. Geological Survey’s quest to establish criteria by which to judge its own digital preservation resources as Trusted Digital Repositories. Drivers included recent U.S. legislation focused on data and asset management conducted by federal agencies spending $100M USD or more annually on research activities. The methods entailed seeking existing evaluation criteria from national and international organizations such as International Standards Organization (ISO), U.S. Library of Congress, and Data Seal of Approval upon which to model USGS repository evaluations. Certification, complexity, cost, and usability of existing evaluation models were key considerations. The selected evaluation method was derived to allow the repository evaluation process to be transparent, understandable, and defensible; factors that are critical for judging competing, internal units. Implementing the chosen evaluation criteria involved establishing a cross-agency, multi-disciplinary team that interfaced across the organization. 

  1. Executive summary of the Diagnostic Criteria for Temporomandibular Disorders for clinical and research applications.

    Schiffman, Eric; Ohrbach, Richard

    2016-06-01

    In this executive summary, the authors describe a protocol for assessing patients with temporomandibular disorder (TMD). It is based on the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for clinical and research applications. The DC/TMD was developed using published Axis I physical diagnoses for the most common TMDs. Axis I diagnostic criteria were derived from pertinent clinical TMD signs and symptoms. Axis II consists of psychosocial and behavioral questionnaires already in the public domain. A panel of experts vetted and modified the Axis I and Axis II diagnostic protocols. Recommended changes were assessed for diagnostic accuracy by using the Validation Project's data set, which formed the basis for the development of the DC/TMD. Axis I diagnostic criteria for TMD pain-related disorders have acceptable validity and provide definitive diagnoses for pain involving the temporomandibular joint (TMJ) and masticatory muscles. Axis I diagnostic criteria for the most common TMJ intra-articular disorders are appropriate for screening purposes only. A definitive diagnosis for TMJ intra-articular disorders requires computed tomography or magnetic resonance imaging. Axis II questionnaires provide valid assessment of psychosocial and behavioral factors that can affect management of TMD. The DC/TMD provides a questionnaire for the pain history in conjunction with validated clinical examination criteria for diagnosing the most common TMDs. In addition, it provides Axis II questionnaires for assessing psychosocial and behavioral factors that may contribute to the onset and perpetuation of the patient's TMD. The DC/TMD is appropriate for use in clinical and research settings to allow for a comprehensive assessment of patients with TMD. Copyright © 2016 American Dental Association. Published by Elsevier Inc. All rights reserved.

  2. AAPT Diagnostic Criteria for Chronic Sickle Cell Disease Pain.

    Dampier, Carlton; Palermo, Tonya M; Darbari, Deepika S; Hassell, Kathryn; Smith, Wally; Zempsky, William

    2017-05-01

    Pain in sickle cell disease (SCD) is associated with increased morbidity, mortality, and high health care costs. Although episodic acute pain is the hallmark of this disorder, there is an increasing awareness that chronic pain is part of the pain experience of many older adolescents and adults. A common set of criteria for classifying chronic pain associated with SCD would enhance SCD pain research efforts in epidemiology, pain mechanisms, and clinical trials of pain management interventions, and ultimately improve clinical assessment and management. As part of the collaborative effort between the Analgesic, Anesthetic, and Addiction Clinical Trial Translations Innovations Opportunities and Networks public-private partnership with the U.S. Food and Drug Administration and the American Pain Society, the Analgesic, Anesthetic, and Addiction Clinical Trial Translations Innovations Opportunities and Networks-American Pain Society Pain Taxonomy initiative developed the outline of an optimal diagnostic system for chronic pain conditions. Subsequently, a working group of experts in SCD pain was convened to generate core diagnostic criteria for chronic pain associated with SCD. The working group synthesized available literature to provide evidence for the dimensions of this disease-specific pain taxonomy. A single pain condition labeled chronic SCD pain was derived with 3 modifiers reflecting different clinical features. Future systematic research is needed to evaluate the feasibility, validity, and reliability of these criteria. An evidence-based classification system for chronic SCD pain was constructed for the Analgesic, Anesthetic, and Addiction Clinical Trial Translations Innovations Opportunities and Networks-American Pain Society Pain Taxonomy initiative. Applying this taxonomy may improve assessment and management of SCD pain and accelerate research on epidemiology, mechanisms, and treatments for chronic SCD pain. Copyright © 2017 The Authors. Published by

  3. Diagnostic criteria for cryopyrin-associated periodic syndrome (CAPS).

    Kuemmerle-Deschner, Jasmin B; Ozen, Seza; Tyrrell, Pascal N; Kone-Paut, Isabelle; Goldbach-Mansky, Raphaela; Lachmann, Helen; Blank, Norbert; Hoffman, Hal M; Weissbarth-Riedel, Elisabeth; Hugle, Boris; Kallinich, Tilmann; Gattorno, Marco; Gul, Ahmet; Ter Haar, Nienke; Oswald, Marlen; Dedeoglu, Fatma; Cantarini, Luca; Benseler, Susanne M

    2017-06-01

    Cryopyrin-associated periodic syndrome (CAPS) is a rare, heterogeneous disease entity associated with NLRP3 gene mutations and increased interleukin-1 (IL-1) secretion. Early diagnosis and rapid initiation of IL-1 inhibition prevent organ damage. The aim of the study was to develop and validate diagnostic criteria for CAPS. An innovative process was followed including interdisciplinary team building, item generation: review of CAPS registries, systematic literature review, expert surveys, consensus conferences for item refinement, item reduction and weighting using 1000Minds decision software. Resulting CAPS criteria were tested in large cohorts of CAPS cases and controls using correspondence analysis. Diagnostic models were explored using sensitivity analyses. The international team included 16 experts. Systematic literature and registry review identified 33 CAPS-typical items; the consensus conferences reduced these to 14. 1000Minds exercises ranked variables based on importance for the diagnosis. Correspondence analysis determined variables consistently associated with the diagnosis of CAPS using 284 cases and 837 controls. Seven variables were significantly associated with CAPS (pCAPS-typical symptoms: urticaria-like rash, cold-triggered episodes, sensorineural hearing loss, musculoskeletal symptoms, chronic aseptic meningitis and skeletal abnormalities. Sensitivity was 81%, specificity 94%. It performed well for all CAPS subtypes and regardless of NLRP3 mutation. The novel approach integrated traditional methods of evidence synthesis with expert consensus, web-based decision tools and innovative statistical methods and may serve as model for other rare diseases. These criteria will enable a rapid diagnosis for children and adults with CAPS. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  4. Operationalization of diagnostic criteria of DSM-5 somatic symptom disorders.

    Xiong, Nana; Zhang, Yaoyin; Wei, Jing; Leonhart, Rainer; Fritzsche, Kurt; Mewes, Ricarda; Hong, Xia; Cao, Jinya; Li, Tao; Jiang, Jing; Zhao, Xudong; Zhang, Lan; Schaefert, Rainer

    2017-11-07

    The aim of this study was to test the operationalization of DSM-5 somatic symptom disorder (SSD) psychological criteria among Chinese general hospital outpatients. This multicenter, cross-sectional study enrolled 491 patients from 10 general hospital outpatient departments. The structured clinical "interview about cognitive, affective, and behavioral features associated with somatic complaints" was used to operationalize the SSD criteria B. For comparison, DSM-IV somatoform disorders were assessed with the Mini International Neuropsychiatric Interview plus. Cohen's к scores were given to illustrate the agreement of the diagnoses. A three-structure model of the interview, within which items were classified as respectively assessing the cognitive (B1), affective (B2), and behavioral (B3) features, was examined. According to percentages of screening-positive persons and the receiver operator characteristic (ROC) analysis, a cut-off point of 2 was recommended for each subscale of the interview. With the operationalization, the frequency of DSM-5 SSD was estimated as 36.5% in our sample, and that of DSM-IV somatoform disorders was 8.2%. The agreement between them was small (Cohen's к = 0.152). Comparisons of sociodemographic features of SSD patients with different severity levels (mild, moderate, severe) showed that mild SSD patients were better-off in terms of financial and employment status, and that the severity subtypes were congruent with the level of depression, anxiety, quality of life impairment, and the frequency of doctor visits. The operationalization of the diagnosis and severity specifications of SSD was valid, but the diagnostic agreement between DSM-5 SSD and DSM-IV somatoform disorders was small. The interpretation the SSD criteria should be made cautiously, so that the diagnosis would not became over-inclusive.

  5. Lesson 6: Signature Validation

    Checklist items 13 through 17 are grouped under the Signature Validation Process, and represent CROMERR requirements that the system must satisfy as part of ensuring that electronic signatures it receives are valid.

  6. Hanford Site solid waste acceptance criteria

    Ellefson, M.D.

    1998-01-01

    Order 5820.2A requires that each treatment, storage, and/or disposal facility (referred to in this document as TSD unit) that manages low-level or transuranic waste (including mixed waste and TSCA PCB waste) maintain waste acceptance criteria. These criteria must address the various requirements to operate the TSD unit in compliance with applicable safety and environmental requirements. This document sets forth the baseline criteria for acceptance of radioactive waste at TSD units operated by WMH. The criteria for each TSD unit have been established to ensure that waste accepted can be managed in a manner that is within the operating requirements of the unit, including environmental regulations, DOE Orders, permits, technical safety requirements, waste analysis plans, performance assessments, and other applicable requirements. Acceptance criteria apply to the following TSD units: the Low-Level Burial Grounds (LLBG) including both the nonregulated portions of the LLBG and trenches 31 and 34 of the 218-W-5 Burial Ground for mixed waste disposal; Central Waste Complex (CWC); Waste Receiving and Processing Facility (WRAP); and T Plant Complex. Waste from all generators, both from the Hanford Site and from offsite facilities, must comply with these criteria. Exceptions can be granted as provided in Section 1.6. Specific waste streams could have additional requirements based on the 1901 identified TSD pathway. These requirements are communicated in the Waste Specification Records (WSRds). The Hanford Site manages nonradioactive waste through direct shipments to offsite contractors. The waste acceptance requirements of the offsite TSD facility must be met for these nonradioactive wastes. This document does not address the acceptance requirements of these offsite facilities

  7. Clinical Criteria for Physician Aid in Dying.

    Orentlicher, David; Pope, Thaddeus Mason; Rich, Ben A

    2016-03-01

    More than 20 years ago, even before voters in Oregon had enacted the first aid in dying (AID) statute in the United States, Timothy Quill and colleagues proposed clinical criteria AID. Their proposal was carefully considered and temperate, but there were little data on the practice of AID at the time. (With AID, a physician writes a prescription for life-ending medication for a terminally ill, mentally capacitated adult.) With the passage of time, a substantial body of data on AID has developed from the states of Oregon and Washington. For more than 17 years, physicians in Oregon have been authorized to provide a prescription for AID. Accordingly, we have updated the clinical criteria of Quill, et al., based on the many years of experience with AID. With more jurisdictions authorizing AID, it is critical that physicians can turn to reliable clinical criteria. As with any medical practice, AID must be provided in a safe and effective manner. Physicians need to know (1) how to respond to a patient's inquiry about AID, (2) how to assess patient decision making capacity, and (3) how to address a range of other issues that may arise. To ensure that physicians have the guidance they need, Compassion & Choices convened the Physician Aid-in-Dying Clinical Criteria Committee, in July 2012, to create clinical criteria for physicians who are willing to provide AID to patients who request it. The committee includes experts in medicine, law, bioethics, hospice, nursing, social work, and pharmacy. Using an iterative consensus process, the Committee drafted the criteria over a one-year period.

  8. Development of criteria for release of Idaho National Engineering Laboratory sites following decontamination and decommissioning

    Kirol, L.

    1986-08-01

    Criteria have been developed for release of Idaho National Engineering Laboratory (INEL) facilities and land areas following decontamination and decommissioning (D and D). Although these facilities and land areas are not currently being returned to the public domain, and no plans exist for doing so, criteria suitable for unrestricted release to the public were desired. Midway through this study, the implementation of Department of Energy (DOE) Order 5820.2, Radioactive Waste Management, required development of site specific release criteria for use on D and D projects. These criteria will help prevent remedial actions from being required if INEL reuse considerations change in the future. Development of criteria for release of INEL facilities following D and D comprised four study areas: pathways analysis, dose and concentration guidelines, sampling and instrumentation, and implementation procedures. Because of the complex and sensitive nature of the first three categories, a thorough review by experts in those respective fields was desired. Input and support in preparing or reviewing each part of the criteria development task was solicited from several DOE field offices. Experts were identified and contracted to assist in preparing portions of the release criteria, or to serve on a peer-review committee. Thus, the entire release criteria development task was thoroughly reviewed by recognized experts from contractors at several DOE field offices, to validate technical content of the document. Each of the above four study areas was developed originally as an individual task, and a report was generated from each. These reports are combined here to form this document. This release criteria document includes INEL-specific pathways analysis, instrumentation requirements, sampling procedures, the basis for selection of dose and concentration guidelines, and cost-risk-benefit procedures

  9. High sensitivity and specificity in proposed clinical diagnostic criteria for anti-N-methyl-D-aspartate receptor encephalitis.

    Ho, Alvin C C; Mohammad, Shekeeb S; Pillai, Sekhar C; Tantsis, Esther; Jones, Hannah; Ho, Reena; Lim, Ming; Hacohen, Yael; Vincent, Angela; Dale, Russell C

    2017-12-01

    To determine the validity of the proposed clinical diagnostic criteria for anti-N-methyl-d-aspartate receptor (NMDAR) encephalitis in paediatric patients. The diagnostic criteria for anti-NMDAR encephalitis proposed by Graus et al. (2016) use clinical features and conventional investigations to facilitate early immunotherapy before antibody status is available. The criteria are satisfied if patients develop four out of six symptom groups within 3 months, together with at least one abnormal investigation (electroencephalography/cerebrospinal fluid) and reasonable exclusion of other disorders. We evaluated the validity of the criteria using a retrospective cohort of paediatric patients with encephalitis. Twenty-nine patients with anti-NMDAR encephalitis and 74 comparison children with encephalitis were included. As expected, the percentage of patients with anti-NMDAR encephalitis who fulfilled the clinical criteria increased over time. During the hospital inpatient admission, most patients (26/29, 90%) with anti-NMDAR encephalitis fulfilled the criteria, significantly more than the comparison group (3/74, 4%) (panti-NMDAR encephalitis was 2 weeks from first symptom onset (range 1-6). The sensitivity of the criteria was 90% (95% confidence interval 73-98) and the specificity was 96% (95% confidence interval 89-99). The proposed diagnostic criteria for anti-NMDAR encephalitis have good sensitivity and specificity. Incomplete criteria do not exclude the diagnosis. The proposed clinical diagnostic criteria for anti-N-methyl-d-aspartate receptor (NMDAR) encephalitis by Graus et al. (2016) have high sensitivity and specificity in paediatric patients. The median time of fulfilling the criteria in patients with anti-NMDAR was 2 weeks from first symptom onset. © 2017 Mac Keith Press.

  10. Criteria for the PNE seismic network

    Pruvost, N.L.

    1978-01-01

    A 1976 treaty between the United States and the Soviet Union permits a local seismic network to be deployed at the site of a peaceful nuclear explosion to monitor the event. Criteria for the design and selection of the data-acquisition equipment for such a network are provided. Constraints imposed by the protocol of the treaty, the environment, and the expected properties of seismic signals (based on experiences at the Nevada Test Site) are discussed. Conclusions are drawn about the desired operating mode. Criteria for a general seismic instrumentation system are described

  11. History and Evolution of the Johnson Criteria.

    Sjaardema, Tracy A. [Sandia National Laboratories (SNL-NM), Albuquerque, NM (United States); Smith, Collin S. [Sandia National Laboratories (SNL-NM), Albuquerque, NM (United States); Birch, Gabriel Carisle [Sandia National Laboratories (SNL-NM), Albuquerque, NM (United States)

    2015-07-01

    The Johnson Criteria metric calculates probability of detection of an object imaged by an optical system, and was created in 1958 by John Johnson. As understanding of target detection has improved, detection models have evolved to better model additional factors such as weather, scene content, and object placement. The initial Johnson Criteria, while sufficient for technology and understanding at the time, does not accurately reflect current research into target acquisition and technology. Even though current research shows a dependence on human factors, there appears to be a lack of testing and modeling of human variability.

  12. Hanford Site Solid Waste Acceptance Criteria

    1993-11-17

    This manual defines the Hanford Site radioactive, hazardous, and sanitary solid waste acceptance criteria. Criteria in the manual represent a guide for meeting state and federal regulations; DOE Orders; Hanford Site requirements; and other rules, regulations, guidelines, and standards as they apply to acceptance of radioactive and hazardous solid waste at the Hanford Site. It is not the intent of this manual to be all inclusive of the regulations; rather, it is intended that the manual provide the waste generator with only the requirements that waste must meet in order to be accepted at Hanford Site TSD facilities.

  13. Packaging design criteria for the MCO cask

    Clements, M.D.

    1996-01-01

    Approximately 2,100 metric tons of unprocessed, irradiated nuclear fuel elements are presently stored in the K Basins. To permit cleanup of the K Basins and fuel conditioning, the fuel will be transported from the K Basins to a Canister Storage Building in the 200 East Area. The purpose of this packaging design criteria is to provide criteria for the design, fabrication, and use of a packaging system to transport the large quantities of irradiated nuclear fuel elements positioned within Multiple Canister Overpacks

  14. Design criteria for prestressed concrete pressure vessels

    Schimmelpfennig, K.

    1989-01-01

    The work concerned with the PCRVs has been focussed on topics which are not sufficiently covered by the usual codes with respect to the special structure of PCRVs and the special demands on it, and different investigations yielding a basis for such specific design criteria have been carried out. Only a couple of subjects being in the fore under the aspect of defining quality enlarging design criteria for PCRVs are outlined. The materials for the concrete to be used for the PCRVs are carefully selected. (DG)

  15. Criteria for safety-related operator actions

    Gray, L.H.; Haas, P.M.

    1983-01-01

    The Safety-Related Operator Actions (SROA) Program was designed to provide information and data for use by NRC in assessing the performance of nuclear power plant (NPP) control room operators in responding to abnormal/emergency events. The primary effort involved collection and assessment of data from simulator training exercises and from historical records of abnormal/emergency events that have occurred in operating plants (field data). These data can be used to develop criteria for acceptability of the use of manual operator action for safety-related functions. Development of criteria for safety-related operator actions are considered

  16. Proliferation resistance criteria for fissile material disposition

    Close, D.A.; Fearey, B.L.; Markin, J.T.; Rutherford, D.A.; Duggan, R.A.; Jaeger, C.D.; Mangan, D.L.; Moya, R.W.; Moore, L.R.; Strait, R.S.

    1995-04-01

    The 1994 National Academy of Sciences study open-quotes Management and Disposition of Excess Weapons Plutoniumclose quotes defined options for reducing the national and international proliferation risks of materials declared excess to the nuclear weapons program. This report proposes criteria for assessing the proliferation resistance of these options. The criteria are general, encompassing all stages of the disposition process from storage through intermediate processing to final disposition including the facilities, processing technologies and materials, the level of safeguards for these materials, and the national/subnational threat to the materials

  17. NRC licensing criteria for portable radwaste systems

    Hayes, J.J. Jr.

    1983-01-01

    The shortcomings of various components of the liquid and solid radwaste systems at nuclear power reactors has resulted in the contracting of the functions performed by these systems to various contractors who utilize portable equipment. In addition, some streams, for which treatment was not originally anticipated, have been processed by portable equipment. The NRC criteria applicable to portable liquid and solid radwaste systems is presented along with discussion on what is required to provide an adequate 10 CFR Part 50.59 review for those situations where changes are made to an existing system. The criteria the NRC is considering for facilities which may intend to utilize portable incinerators is also presented

  18. Snell Envelope with Small Probability Criteria

    Del Moral, Pierre, E-mail: Pierre.Del-Moral@inria.fr; Hu, Peng, E-mail: Peng.Hu@inria.fr [Universite de Bordeaux I, Centre INRIA Bordeaux et Sud-Ouest and Institut de Mathematiques de Bordeaux (France); Oudjane, Nadia, E-mail: Nadia.Oudjane@edf.fr [EDF R and D Clamart (France)

    2012-12-15

    We present a new algorithm to compute the Snell envelope in the specific case where the criteria to optimize is associated with a small probability or a rare event. This new approach combines the Stochastic Mesh approach of Broadie and Glasserman with a particle approximation scheme based on a specific change of measure designed to concentrate the computational effort in regions pointed out by the criteria. The theoretical analysis of this new algorithm provides non asymptotic convergence estimates. Finally, the numerical tests confirm the practical interest of this approach.

  19. Hanford Site Solid Waste Acceptance Criteria

    1993-01-01

    This manual defines the Hanford Site radioactive, hazardous, and sanitary solid waste acceptance criteria. Criteria in the manual represent a guide for meeting state and federal regulations; DOE Orders; Hanford Site requirements; and other rules, regulations, guidelines, and standards as they apply to acceptance of radioactive and hazardous solid waste at the Hanford Site. It is not the intent of this manual to be all inclusive of the regulations; rather, it is intended that the manual provide the waste generator with only the requirements that waste must meet in order to be accepted at Hanford Site TSD facilities

  20. NEVADA TEST SITE WASTE ACCEPTANCE CRITERIA

    U.S. DEPARTMENT OF ENERGY, NATIONAL NUCLEAR SECURITY ADMINISTRATION, NEVADA SITE OFFICE

    2005-01-01

    This document establishes the U. S. Department of Energy, National Nuclear Security Administration Nevada Site Office (NNSA/NSO) waste acceptance criteria (WAC). The WAC provides the requirements, terms, and conditions under which the Nevada Test Site will accept low-level radioactive and mixed waste for disposal. Mixed waste generated within the State of Nevada by NNSA/NSO activities is accepted for disposal. It includes requirements for the generator waste certification program, characterization, traceability, waste form, packaging, and transfer. The criteria apply to radioactive waste received at the Nevada Test Site Area 3 and Area 5 Radioactive Waste Management Site for storage or disposal