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

Science.gov (United States)

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.

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

DEFF Research Database (Denmark)

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...

Update on the OMERACT Magnetic Resonance Imaging Task Force

DEFF Research Database (Denmark)

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....

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

Science.gov (United States)

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.

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

Science.gov (United States)

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.

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

DEFF Research Database (Denmark)

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...

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

DEFF Research Database (Denmark)

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...

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

DEFF Research Database (Denmark)

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...

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

NARCIS (Netherlands)

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

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

DEFF Research Database (Denmark)

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....

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

Science.gov (United States)

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.

Validating Rheumatoid Arthritis Remission Using the Patients' Perspective

DEFF Research Database (Denmark)

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...

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

Science.gov (United States)

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.

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

DEFF Research Database (Denmark)

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...

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

DEFF Research Database (Denmark)

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...

The OMERACT Ultrasound Working Group 10 Years On

DEFF Research Database (Denmark)

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...

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

Science.gov (United States)

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.

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

DEFF Research Database (Denmark)

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...

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

DEFF Research Database (Denmark)

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...

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

NARCIS (Netherlands)

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,

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

Science.gov (United States)

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.

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

DEFF Research Database (Denmark)

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....

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

Science.gov (United States)

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.

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

Science.gov (United States)

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

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

Science.gov (United States)

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.

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

DEFF Research Database (Denmark)

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...

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

DEFF Research Database (Denmark)

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...

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

DEFF Research Database (Denmark)

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...

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

Science.gov (United States)

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.

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

Science.gov (United States)

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.

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

DEFF Research Database (Denmark)

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...

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

NARCIS (Netherlands)

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

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

DEFF Research Database (Denmark)

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...

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

Science.gov (United States)

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.

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

DEFF Research Database (Denmark)

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....

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

Science.gov (United States)

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

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

DEFF Research Database (Denmark)

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...

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

DEFF Research Database (Denmark)

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...

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

DEFF Research Database (Denmark)

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 ...

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

DEFF Research Database (Denmark)

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...

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

DEFF Research Database (Denmark)

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...

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

Science.gov (United States)

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.

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.

Science.gov (United States)

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.

Validation criteria of an internal dosimetry laboratory in vivo

International Nuclear Information System (INIS)

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)

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

Science.gov (United States)

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...

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

DEFF Research Database (Denmark)

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...

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

Science.gov (United States)

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.

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

Science.gov (United States)

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

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

Science.gov (United States)

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.

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

DEFF Research Database (Denmark)

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...

Musculoskeletal ultrasound including definitions for ultrasonographic pathology

DEFF Research Database (Denmark)

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....

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

Science.gov (United States)

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.

Musculoskeletal ultrasound including definitions for ultrasonographic pathology

DEFF Research Database (Denmark)

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....

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.

Science.gov (United States)

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.

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

Science.gov (United States)

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.

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

Science.gov (United States)

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)

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

NARCIS (Netherlands)

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

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

NARCIS (Netherlands)

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

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

Directory of Open Access Journals (Sweden)

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.

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.

Science.gov (United States)

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

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

International Nuclear Information System (INIS)

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

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

NARCIS (Netherlands)

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

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

NARCIS (Netherlands)

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

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

Science.gov (United States)

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…

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

Science.gov (United States)

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.

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

International Nuclear Information System (INIS)

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

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

Science.gov (United States)

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.

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

Directory of Open Access Journals (Sweden)

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.

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

Science.gov (United States)

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.

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

DEFF Research Database (Denmark)

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....

Criteria of the validation of experimental and evaluated covariance data

International Nuclear Information System (INIS)

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

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

Science.gov (United States)

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

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

Energy Technology Data Exchange (ETDEWEB)

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

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

DEFF Research Database (Denmark)

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 (

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

Directory of Open Access Journals (Sweden)

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

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

NARCIS (Netherlands)

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

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

Science.gov (United States)

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.

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

Directory of Open Access Journals (Sweden)

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

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

Directory of Open Access Journals (Sweden)

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.

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

Directory of Open Access Journals (Sweden)

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.

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

Science.gov (United States)

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.

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

Energy Technology Data Exchange (ETDEWEB)

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.

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

Science.gov (United States)

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.

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

International Nuclear Information System (INIS)

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

[Criteria of scientific validity in research].

Science.gov (United States)

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.

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

NARCIS (Netherlands)

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

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

DEFF Research Database (Denmark)

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...

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

Science.gov (United States)

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.

Magnetic resonance imaging in rheumatoid arthritis advances and research priorities

DEFF Research Database (Denmark)

Østergaard, Mikkel; McQueen, FM; Bird, P

2005-01-01

Magnetic resonance imaging (MRI) has now been used extensively in cross-sectional and observational studies as well as in controlled clinical trials to assess disease activity and joint damage in rheumatoid arthritis (RA). MRI measurements or scores for erosions, bone edema, and synovitis have be......, and financial context of the study in question. We review the extent to which MRI assessments of joint erosion, bone edema, and synovitis fulfil these criteria, particularly as they relate to proof-of-concept RA clinical trials.......Magnetic resonance imaging (MRI) has now been used extensively in cross-sectional and observational studies as well as in controlled clinical trials to assess disease activity and joint damage in rheumatoid arthritis (RA). MRI measurements or scores for erosions, bone edema, and synovitis have been...... developed and validated by several groups. The OMERACT criteria require that outcome measures demonstrate adequate validity, discriminative power, and feasibility if they are to be useful in clinical trials. Specific performance targets for these criteria depend on the scientific, regulatory, logistical...

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

Energy Technology Data Exchange (ETDEWEB)

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

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

Science.gov (United States)

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.

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

Science.gov (United States)

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.

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

Science.gov (United States)

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…

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

Science.gov (United States)

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

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

Science.gov (United States)

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.

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

Directory of Open Access Journals (Sweden)

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.

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

Science.gov (United States)

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…

Simulation Methods and Validation Criteria for Modeling Cardiac Ventricular Electrophysiology.

Directory of Open Access Journals (Sweden)

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.

Simulation Methods and Validation Criteria for Modeling Cardiac Ventricular Electrophysiology.

Science.gov (United States)

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.

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

LENUS (Irish Health Repository)

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.

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

Science.gov (United States)

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.

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

Science.gov (United States)

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.

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

International Nuclear Information System (INIS)

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.

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

DEFF Research Database (Denmark)

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...

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

Directory of Open Access Journals (Sweden)

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.

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

Science.gov (United States)

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.

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

Energy Technology Data Exchange (ETDEWEB)

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)

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

Science.gov (United States)

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.

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

Science.gov (United States)

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.

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

Energy Technology Data Exchange (ETDEWEB)

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.

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

International Nuclear Information System (INIS)

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

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

Science.gov (United States)

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.

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

Science.gov (United States)

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.

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

NARCIS (Netherlands)

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

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

Energy Technology Data Exchange (ETDEWEB)

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)

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

NARCIS (Netherlands)

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

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

Science.gov (United States)

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

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

Science.gov (United States)

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

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

Science.gov (United States)

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.

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

Science.gov (United States)

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.

Proposed diagnostic criteria for internet addiction.

Science.gov (United States)

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.

Proposal for Requirement Validation Criteria and Method Based on Actor Interaction

Science.gov (United States)

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.

[Primary childhood vasculitis new classification criteria

DEFF Research Database (Denmark)

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...

A converse to linear independence criteria, valid almost everywhere

DEFF Research Database (Denmark)

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....

Evaluation Criteria for the Educational Web-Information System

Science.gov (United States)

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…

Validation of potential classification criteria for systemic sclerosis.

NARCIS (Netherlands)

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

Toward the Development of a Core Set of Outcome Domains to Assess Shared Decision-making Interventions in Rheumatology

DEFF Research Database (Denmark)

Toupin-April, Karine; Barton, Jennifer; Fraenkel, Liana

2017-01-01

OBJECTIVE: The aim of this Outcome Measures in Rheumatology (OMERACT) Working Group was to determine the core set of outcome domains and subdomains for measuring the effectiveness of shared decision-making (SDM) interventions in rheumatology clinical trials. METHODS: Following the OMERACT Filter 2.......0, and based on a previous literature review of SDM outcome domains and a nominal group process at OMERACT 2014, (1) an online Delphi survey was conducted to gather feedback on the draft core set and refine its domains and subdomains, and (2) a workshop was held at the OMERACT 2016 meeting to gain consensus...... ranged from 83% to 100% of respondents). At OMERACT 2016, only 8% of the 96 attendees were patients/caregivers. Despite initial votes of support in breakout groups, there was insufficient comfort about the conceptualization of these 7 domains and 17 subdomains for these to be endorsed at OMERACT 2016...

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

NARCIS (Netherlands)

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

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

Science.gov (United States)

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.

A demonstration of NIOSH push-pull ventilation criteria.

Science.gov (United States)

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.

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

Science.gov (United States)

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.

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

Science.gov (United States)

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.

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

DEFF Research Database (Denmark)

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...

Comprehensive Evaluation Criteria for English Learning Websites Using Expert Validity Surveys

Science.gov (United States)

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…

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

Science.gov (United States)

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.

Assessment of Clinical Criteria for Sepsis

Science.gov (United States)

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

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

Directory of Open Access Journals (Sweden)

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.

Updating the Psoriatic Arthritis (PsA) Core Domain Set

DEFF Research Database (Denmark)

Orbai, Ana-Maria; de Wit, Maarten; Mease, Philip J

2017-01-01

OBJECTIVE: 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). METHODS: 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. RESULTS: We conducted a systematic literature review of domains measured in PsA RCT and LOS, and identified 24 domains. We conducted...... 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...

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

International Nuclear Information System (INIS)

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)

New criteria on the existence of stable-limit cycles

Energy Technology Data Exchange (ETDEWEB)

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).

TWO CRITERIA FOR GOOD MEASUREMENTS IN RESEARCH: VALIDITY AND RELIABILITY

Directory of Open Access Journals (Sweden)

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.

Verification, validation, and reliability of predictions

International Nuclear Information System (INIS)

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

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

DEFF Research Database (Denmark)

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...

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

Science.gov (United States)

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.

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

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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.

Criteria for saturated magnetization loop

International Nuclear Information System (INIS)

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.

Criteria for saturated magnetization loop

Energy Technology Data Exchange (ETDEWEB)

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.

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

Science.gov (United States)

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.

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

International Nuclear Information System (INIS)

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

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.

Science.gov (United States)

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.

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

Science.gov (United States)

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

Research into care quality criteria for long-term care institutions.

Science.gov (United States)

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.

On the validation of risk analysis-A commentary

International Nuclear Information System (INIS)

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.

Proposed Diagnostic Criteria for Smartphone Addiction.

Science.gov (United States)

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.

Proposed Diagnostic Criteria for Smartphone Addiction.

Directory of Open Access Journals (Sweden)

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.

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

Science.gov (United States)

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.

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

Directory of Open Access Journals (Sweden)

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

Application of a Framework to Assess the Usefulness of Alternative Sepsis Criteria.

Science.gov (United States)

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.

What is validation

International Nuclear Information System (INIS)

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

Verification and validation for waste disposal models

International Nuclear Information System (INIS)

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

Nuclear Fuel Safety Criteria Technical Review - Second edition

International Nuclear Information System (INIS)

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)

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

Science.gov (United States)

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

Squale: evaluation criteria of functioning safety

International Nuclear Information System (INIS)

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.)

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

Science.gov (United States)

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.

A Framework for the Development and Interpretation of Different Sepsis Definitions and Clinical Criteria.

Science.gov (United States)

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.

Validation of a rubric to assess innovation competence

Directory of Open Access Journals (Sweden)

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.

Development of a Draft Core Set of Domains for Measuring Shared Decision Making in Osteoarthritis

DEFF Research Database (Denmark)

Toupin-April, Karine; Barton, Jennifer; Fraenkel, Liana

2015-01-01

OBJECTIVE: 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. METHODS: 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. RESULTS: In all, 26 people from Europe, North America, and Australia, including 5 patient research partners...

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

Directory of Open Access Journals (Sweden)

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

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

Science.gov (United States)

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.

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

Science.gov (United States)

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.

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

Energy Technology Data Exchange (ETDEWEB)

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.

The validity of the Michigan Alcoholism Screening Test (MAST)

DEFF Research Database (Denmark)

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...

Development of outcome measures for large-vessel vasculitis for use in clinical trials: opportunities, challenges, and research agenda.

Science.gov (United States)

Direskeneli, Haner; Aydin, Sibel Z; Kermani, Tanaz A; Matteson, Eric L; Boers, Maarten; Herlyn, Karen; Luqmani, Raashid A; Neogi, Tuhina; Seo, Philip; Suppiah, Ravi; Tomasson, Gunnar; Merkel, Peter A

2011-07-01

Giant cell (GCA) and Takayasu's arteritis (TAK) are 2 forms of large-vessel vasculitis (LVV) that involve the aorta and its major branches. GCA has a predilection for the cranial branches, while TAK tends to affect the extracranial branches. Both disorders may also cause nonspecific constitutional symptoms. Although some clinical features are more common in one or the other disorder and the ages of initial presentation differ substantially, there is enough clinical and histopathologic overlap between these disorders that some investigators suggest GCA and TAK may be 2 processes within the spectrum of a single disease. There have been few randomized therapeutic trials completed in GCA, and none in TAK. The lack of therapeutic trials in LVV is only partially explained by the rarity of these diseases. It is likely that the lack of well validated outcome measures for LVV and uncertainties regarding trial design contribute to the paucity of trials for these diseases. An initiative to develop a core set of outcome measures for use in clinical trials of LVV was launched by the international OMERACT Vasculitis Working Group in 2009 and subsequently endorsed by the OMERACT community at the OMERACT 10 meeting. Aims of this initiative include: (1) to review the literature and existing data related to outcome assessments in LVV; (2) to obtain the opinion of experts and patients on disease content; and (3) to formulate a research agenda to facilitate a more data-based approach to outcomes development.

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

Science.gov (United States)

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.

The measurement of instrumental ADL: content validity and construct validity

DEFF Research Database (Denmark)

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...

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

DEFF Research Database (Denmark)

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...

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

Science.gov (United States)

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.

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

Science.gov (United States)

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.

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

Science.gov (United States)

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.

CFD validation experiments for hypersonic flows

Science.gov (United States)

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.

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

Directory of Open Access Journals (Sweden)

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.

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

Science.gov (United States)

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.

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

Science.gov (United States)

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.

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

Science.gov (United States)

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

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

Energy Technology Data Exchange (ETDEWEB)

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.

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

Science.gov (United States)

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…

Validation of psychoanalytic theories: towards a conceptualization of references.

Science.gov (United States)

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.

Validity in assessment of prior learning

DEFF Research Database (Denmark)

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...

Statistical criteria for characterizing irradiance time series.

Energy Technology Data Exchange (ETDEWEB)

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.

An assessment of the present criteria for cathodic protection of buried steel pipelines

International Nuclear Information System (INIS)

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

Validation of hospital discharge diagnoses for hypertensive disorders of pregnancy

DEFF Research Database (Denmark)

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....

Executive summary of the Diagnostic Criteria for Temporomandibular Disorders for clinical and research applications.

Science.gov (United States)

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.

Toward a Unified Validation Framework in Mixed Methods Research

Science.gov (United States)

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…

Evaluating Dependence Criteria for Caffeine.

Science.gov (United States)

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.

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

DEFF Research Database (Denmark)

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...

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

Science.gov (United States)

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.

American College of Rheumatology provisional criteria for defining clinical inactive disease in select categories of juvenile idiopathic arthritis.

Science.gov (United States)

Wallace, Carol A; Giannini, Edward H; Huang, Bin; Itert, Lukasz; Ruperto, Nicolino

2011-07-01

To prospectively validate the preliminary criteria for clinical inactive disease (CID) in patients with select categories of juvenile idiopathic arthritis (JIA). We used the process for development of classification and response criteria recommended by the American College of Rheumatology Quality of Care Committee. Patient-visit profiles were extracted from the phase III randomized controlled trial of infliximab in polyarticular-course JIA (i.e., patients considered to resemble those with select categories of JIA) and sent to an international group of expert physician raters. Using the physician ratings as the gold standard, the sensitivity and specificity were calculated using the preliminary criteria. Modifications to the criteria were made, and these were sent to a larger group of pediatric rheumatologists to determine quantitative, face, and content validity. Variables weighted heaviest by physicians when making their judgment were the number of joints with active arthritis, erythrocyte sedimentation rate (ESR), physician's global assessment, and duration of morning stiffness. Three modifications were made: the definition of uveitis, the definition of abnormal ESR, and the addition of morning stiffness. These changes did not alter the accuracy of the preliminary set. The modified criteria, termed the "criteria for CID in select categories of JIA," have excellent feasibility and face, content, criterion, and discriminant validity to detect CID in select categories of JIA. The small changes made to the preliminary criteria set did not alter the area under the receiver operating characteristic curve (0.954) or accuracy (91%), but have increased face and content validity. Copyright © 2011 by the American College of Rheumatology.

Assessment of juveniles testimonies’ validity

Directory of Open Access Journals (Sweden)

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

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

Science.gov (United States)

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.

Evaluation Criteria and Indicators of Quality for Internet Resources.

Science.gov (United States)

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…

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

International Nuclear Information System (INIS)

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

Diagnostic accuracy of the Salzburg EEG criteria for non-convulsive status epilepticus

DEFF Research Database (Denmark)

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...

Analysis of expert validation on developing integrated science worksheet to improve problem solving skills of natural science prospective teachers

Science.gov (United States)

Widodo, W.; Sudibyo, E.; Sari, D. A. P.

2018-04-01

This study aims to develop student worksheets for higher education that apply integrated science learning in discussing issues about motion in humans. These worksheets will guide students to solve the problem about human movement. They must integrate their knowledge about biology, physics, and chemistry to solve the problem. The worksheet was validated by three experts in Natural Science Integrated Science, especially in Human Movement topic. The aspects of the validation were feasibility of the content, the construction, and the language. This research used the Likert scale to measure the validity of each aspect, which is 4.00 for very good validity criteria, 3.00 for good validity criteria, 2.00 for more or less validity criteria, and 1.00 for not good validity criteria. Data showed that the validity for each aspect were in the range of good validity and very good validity criteria (3.33 to 3.67 for the content aspect, 2.33 to 4.00 for the construction aspect, and 3.33 to 4.00 for language aspect). However, there was a part of construction aspect that needed to improve. Overall, this students’ worksheet can be applied in classroom after some revisions based on suggestions from the validators.

A CFD validation roadmap for hypersonic flows

Science.gov (United States)

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.

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

DEFF Research Database (Denmark)

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)....

Proposed diagnosis criteria for inflicted head injury of children younger than two years of age

International Nuclear Information System (INIS)

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)

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

Science.gov (United States)

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

Validation of a Knowledge Transfer Tool According to the OMERACT Filter

DEFF Research Database (Denmark)

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...

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

Directory of Open Access Journals (Sweden)

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.

Fast evaluation of 69 basal cell carcinomas with ex vivo fluorescence confocal microscopy: criteria description, histopathological correlation, and interobserver agreement.

Science.gov (United States)

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.

Incidence of Complex Regional Pain Syndrome I Following Foot and Ankle Fractures Using the Budapest Criteria.

Science.gov (United States)

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.

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

DEFF Research Database (Denmark)

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....

Evidence-based provisional clinical classification criteria for autoinflammatory periodic fevers

NARCIS (Netherlands)

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

Criteria for quantitative and qualitative data integration: mixed-methods research methodology.

Science.gov (United States)

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.

Cross-Validation of Survival Bump Hunting by Recursive Peeling Methods.

Science.gov (United States)

Dazard, Jean-Eudes; Choe, Michael; LeBlanc, Michael; Rao, J Sunil

2014-08-01

We introduce a survival/risk bump hunting framework to build a bump hunting model with a possibly censored time-to-event type of response and to validate model estimates. First, we describe the use of adequate survival peeling criteria to build a survival/risk bump hunting model based on recursive peeling methods. Our method called "Patient Recursive Survival Peeling" is a rule-induction method that makes use of specific peeling criteria such as hazard ratio or log-rank statistics. Second, to validate our model estimates and improve survival prediction accuracy, we describe a resampling-based validation technique specifically designed for the joint task of decision rule making by recursive peeling (i.e. decision-box) and survival estimation. This alternative technique, called "combined" cross-validation is done by combining test samples over the cross-validation loops, a design allowing for bump hunting by recursive peeling in a survival setting. We provide empirical results showing the importance of cross-validation and replication.

Intermittent explosive disorder: development of integrated research criteria for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.

Science.gov (United States)

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.

Participatory flood vulnerability assessment: a multi-criteria approach

Science.gov (United States)

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.

Surrogate Endpoint Evaluation: Principal Stratification Criteria and the Prentice Definition.

Science.gov (United States)

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

Surrogate Endpoint Evaluation: Principal Stratification Criteria and the Prentice Definition

Science.gov (United States)

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

Alternative microbial methods: An overview and selection criteria.

Science.gov (United States)

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.

CRITERIA FOR INVESTING IN THE MARKET FOR THE VISUAL ARTS

Directory of Open Access Journals (Sweden)

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.

Overview of core designs and requirements/criteria for core restraint systems

International Nuclear Information System (INIS)

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

The development of Assessment of SpondyloArthritis international Society classification criteria for axial spondyloarthritis (part II)

DEFF Research Database (Denmark)

Rudwaleit, M; van der Heijde, D; Landewé, R

2009-01-01

OBJECTIVE: To validate and refine two sets of candidate criteria for the classification/diagnosis of axial spondyloarthritis (SpA). METHODS: All Assessment of SpondyloArthritis international Society (ASAS) members were invited to include consecutively new patients with chronic (> or =3 months) back...... pain of unknown origin that began before 45 years of age. The candidate criteria were first tested in the entire cohort of 649 patients from 25 centres, and then refined in a random selection of 40% of cases and thereafter validated in the remaining 60%. RESULTS: Upon diagnostic work-up, axial Sp...

Analysis of patterns of three-phase bone scintigraphy for patients with complex regional pain syndrome diagnosed using the proposed research criteria (the 'Budapest Criteria').

Science.gov (United States)

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.

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

National Research Council Canada - National Science Library

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...

A multi-criteria decision-making approach to rank supplier selection criteria for hospital waste management: A case from Pakistan.

Science.gov (United States)

Ishtiaq, Palvisha; Khan, Sharfuddin Ahmed; Haq, Moiz-Ul

2018-04-01

To address environmental issues and cost effectiveness, waste management is necessary for healthcare facilities. Most importantly, segregation of hazardous and non-hazardous waste must be done as in many developing countries; disposal of both types of healthcare waste is done together, which is an unsafe practice. Waste generated in hospitals needs proper management to minimise hazards for patient and healthcare workers. At the same time, it is quite difficult for hospitals to find a systematic way to select appropriate suppliers for hospital waste management. Therefore, the purpose of this article is to identify, validate, and rank criteria that are essential for hospital waste management suppliers' selection. The analytical hierarchal process approach has been used and a survey from Pakistan's largest city (Karachi) has been considered to rank the most appropriate criteria that is necessary to select the supplier, especially in a developing country like Pakistan. Results show that waste management cost (45.5%) and suppliers' details (31.5%) are the top two main criteria for supplier selection; and storage cost (15.7%), waste handling cost (14.7%), and qualification of the suppliers (10.9%) are the top three most important overall sub-criteria for supplier selection for hospital waste management.

Idaho National Engineering Laboratory release criteria for decontamination and decommissioning

International Nuclear Information System (INIS)

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

What to Do With "Moderate" Reliability and Validity Coefficients?

NARCIS (Netherlands)

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

Establishing a core domain set to measure rheumatoid arthritis flares

DEFF Research Database (Denmark)

Bykerk, Vivian P; Lie, Elisabeth; Bartlett, Susan J

2014-01-01

OBJECTIVE: The OMERACT Rheumatoid Arthritis (RA) Flare Group (FG) is developing a data-driven, patient-inclusive, consensus-based RA flare definition for use in clinical trials, longterm observational studies, and clinical practice. At OMERACT 11, we sought endorsement of a proposed core domain set...... to measure RA flare. METHODS: Patient and healthcare professional (HCP) qualitative studies, focus groups, and literature review, followed by patient and HCP Delphi exercises including combined Delphi consensus at Outcome Measures in Rheumatology 10 (OMERACT 10), identified potential domains to measure flare...... Filter 2.0 methodology. RESULTS: A pre-meeting combined Delphi exercise for defining flare identified 9 domains as important (>70% consensus from patients or HCP). Four new patient-reported domains beyond those included in the RA disease activity core set were proposed for inclusion (fatigue...

A long-term validation of the modernised DC-ARC-OES solid-sample method.

Science.gov (United States)

Flórián, K; Hassler, J; Förster, O

2001-12-01

The validation procedure based on ISO 17025 standard has been used to study and illustrate both the longterm stability of the calibration process of the DC-ARC solid sample spectrometric method and the main validation criteria of the method. In the calculation of the validation characteristics depending on the linearity(calibration), also the fulfilment of predetermining criteria such as normality and homoscedasticity was checked. In order to decide whether there are any trends in the time-variation of the analytical signal or not, also the Neumann test of trend was applied and evaluated. Finally, a comparison with similar validation data of the ETV-ICP-OES method was carried out.

Validation test case generation based on safety analysis ontology

International Nuclear Information System (INIS)

Fan, Chin-Feng; Wang, Wen-Shing

2012-01-01

Highlights: ► Current practice in validation test case generation for nuclear system is mainly ad hoc. ► This study designs a systematic approach to generate validation test cases from a Safety Analysis Report. ► It is based on a domain-specific ontology. ► Test coverage criteria have been defined and satisfied. ► A computerized toolset has been implemented to assist the proposed approach. - Abstract: Validation tests in the current nuclear industry practice are typically performed in an ad hoc fashion. This study presents a systematic and objective method of generating validation test cases from a Safety Analysis Report (SAR). A domain-specific ontology was designed and used to mark up a SAR; relevant information was then extracted from the marked-up document for use in automatically generating validation test cases that satisfy the proposed test coverage criteria; namely, single parameter coverage, use case coverage, abnormal condition coverage, and scenario coverage. The novelty of this technique is its systematic rather than ad hoc test case generation from a SAR to achieve high test coverage.

Incremental Validity of the Trait Emotional Intelligence Questionnaire-Short Form (TEIQue-SF).

Science.gov (United States)

Siegling, A B; Vesely, Ashley K; Petrides, K V; Saklofske, Donald H

2015-01-01

This study examined the incremental validity of the adult short form of the Trait Emotional Intelligence Questionnaire (TEIQue-SF) in predicting 7 construct-relevant criteria beyond the variance explained by the Five-factor model and coping strategies. Additionally, the relative contributions of the questionnaire's 4 subscales were assessed. Two samples of Canadian university students completed the TEIQue-SF, along with measures of the Big Five, coping strategies (Sample 1 only), and emotion-laden criteria. The TEIQue-SF showed consistent incremental effects beyond the Big Five or the Big Five and coping strategies, predicting all 7 criteria examined across the 2 samples. Furthermore, 2 of the 4 TEIQue-SF subscales accounted for the measure's incremental validity. Although the findings provide good support for the validity and utility of the TEIQue-SF, directions for further research are emphasized.

Overview of core designs and requirements/criteria for core restraint systems

International Nuclear Information System (INIS)

Sutherland, W.H.

1984-01-01

The requirements and lifetime criteria for the design of a Liquid Metal Fast Breeder Reactor (LMFBR) Core Restraint System is 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. (author)

The cross-cultural validity of posttraumatic stress disorder: implications for DSM-5.

Science.gov (United States)

Hinton, Devon E; Lewis-Fernández, Roberto

2011-09-01

There is considerable debate about the cross-cultural applicability of the posttraumatic stress disorder (PTSD) category as currently specified. Concerns include the possible status of PTSD as a Western culture-bound disorder and the validity of individual items and criteria thresholds. This review examines various types of cross-cultural validity of the PTSD criteria as defined in DSM-IV-TR, and presents options and preliminary recommendations to be considered for DSM-5. Searches were conducted of the mental health literature, particularly since 1994, regarding cultural-, race-, or ethnicity-related factors that might limit the universal applicability of the diagnostic criteria of PTSD in DSM-IV-TR and the possible criteria for DSM-5. Substantial evidence of the cross-cultural validity of PTSD was found. However, evidence of cross-cultural variability in certain areas suggests the need for further research: the relative salience of avoidance/numbing symptoms, the role of the interpretation of trauma-caused symptoms in shaping symptomatology, and the prevalence of somatic symptoms. This review also indicates the need to modify certain criteria, such as the items on distressing dreams and on foreshortened future, to increase their cross-cultural applicability. Text additions are suggested to increase the applicability of the manual across cultural contexts: specifying that cultural syndromes-such as those indicated in the DSM-IV-TR Glossary-may be a prominent part of the trauma response in certain cultures, and that those syndromes may influence PTSD symptom salience and comorbidity. The DSM-IV-TR PTSD category demonstrates various types of validity. Criteria modification and textual clarifications are suggested to further improve its cross-cultural applicability. © 2010 Wiley-Liss, Inc.

Mammography image assessment; validity and reliability of current scheme

International Nuclear Information System (INIS)

Hill, C.; Robinson, L.

2015-01-01

Mammographers currently score their own images according to criteria set out by Regional Quality Assurance. The criteria used are based on the ‘Perfect, Good, Moderate, Inadequate’ (PGMI) marking criteria established by the National Health Service Breast Screening Programme (NHSBSP) in their Quality Assurance Guidelines of 2006 1 . This document discusses the validity and reliability of the current mammography image assessment scheme. Commencing with a critical review of the literature this document sets out to highlight problems with the national approach to the use of marking schemes. The findings suggest that ‘PGMI’ scheme is flawed in terms of reliability and validity and is not universally applied across the UK. There also appear to be differences in schemes used by trainees and qualified mammographers. Initial recommendations are to be made in collaboration with colleagues within the National Health Service Breast Screening Programme (NHSBSP), Higher Education Centres, College of Radiographers and the Royal College of Radiologists in order to identify a mammography image appraisal scheme that is fit for purpose. - Highlights: • Currently no robust evidence based marking tools in use for the assessment of images in mammography. • Is current system valid, reliable and robust? • How can the current image assessment tool be improved? • Should students and qualified mammographers use the same tool? • What marking criteria are available for image assessment?

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

Science.gov (United States)

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…

Systemic inflammatory response syndrome criteria in defining severe sepsis.

Science.gov (United States)

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

Return to play criteria after hamstring muscle injury in professional football: a Delphi consensus study.

Science.gov (United States)

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.

Ethical Implications of Validity-vs.-Reliability Trade-Offs in Educational Research

Science.gov (United States)

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…

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

Science.gov (United States)

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.

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

International Nuclear Information System (INIS)

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

Developing and validating a psychometric scale for image quality assessment

International Nuclear Information System (INIS)

Mraity, H.; England, A.; Hogg, P.

2014-01-01

Purpose: Using AP pelvis as a catalyst, this paper explains how a psychometric scale for image quality assessment can be created using Bandura's theory for self-efficacy. Background: Establishing an accurate diagnosis is highly dependent upon the quality of the radiographic image. Image quality, as a construct (i.e. set of attributes that makes up the image quality), continues to play an essential role in the field of diagnostic radiography. The process of assessing image quality can be facilitated by using criteria, such as the European Commission (EC) guidelines for quality criteria as published in 1996. However, with the advent of new technology (Computed Radiography and Digital Radiography), some of the EC criteria may no longer be suitable for assessing the visual quality of a digital radiographic image. Moreover, a lack of validated visual image quality scales in the literature can also lead to significant variations in image quality evaluation. Creating and validating visual image quality scales, using a robust methodology, could reduce variability and improve the validity and reliability of perceptual image quality evaluations

Participatory flood vulnerability assessment: a multi-criteria approach

Directory of Open Access Journals (Sweden)

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.

Endoscopic Criteria for Evaluating Tumor Stage after Preoperative Chemoradiation Therapy in Locally Advanced Rectal Cancer.

Science.gov (United States)

Han, Kyung Su; Sohn, Dae Kyung; Kim, Dae Yong; Kim, Byung Chang; Hong, Chang Won; Chang, Hee Jin; Kim, Sun Young; Baek, Ji Yeon; Park, Sung Chan; Kim, Min Ju; Oh, Jae Hwan

2016-04-01

Local excision may be an another option for selected patients with markedly down-staged rectal cancer after preoperative chemoradiation therapy (CRT), and proper evaluation of post-CRT tumor stage (ypT) is essential prior to local excision of these tumors. This study was designed to determine the correlations between endoscopic findings and ypT of rectal cancer. In this study, 481 patients with locally advanced rectal cancer who underwent preoperative CRT followed by surgical resection between 2004 and 2013 at a single institution were evaluated retrospectively. Pathological good response (p-GR) was defined as ypT ≤ 1, and pathological minimal or no response (p-MR) as ypT ≥ 2. The patients were randomly classified according to two groups, a testing (n=193) and a validation (n=288) group. Endoscopic criteria were determined from endoscopic findings and ypT in the testing group and used in classifying patients in the validation group as achieving or not achieving p-GR. Based on findings in the testing group, the endoscopic criteria for p-GR included scarring, telangiectasia, and erythema, whereas criteria for p-MR included nodules, ulcers, strictures, and remnant tumors. In the validation group, the kappa statistic was 0.965 (p < 0.001), and the sensitivity, specificity, positive predictive value, and negative predictive value were 0.362, 0.963, 0.654, and 0.885, respectively. The endoscopic criteria presented are easily applicable for evaluation of ypT after preoperative CRT for rectal cancer. These criteria may be used for selection of patients for local excision of down-staged rectal tumors, because patients with p-MR could be easily ruled out.

Clinical Implications of Various Criteria for the Biochemical Diagnosis of Insulinoma

Directory of Open Access Journals (Sweden)

Chang Ho Ahn

2014-12-01

Full Text Available BackgroundAmong the various diagnostic criteria for insulinoma, the ratio criteria have been controversial. However, the amended insulin-glucose ratio exhibited excellent diagnostic performance in a recent retrospective cohort study, although it has not yet been validated in other patient cohorts. We examined the diagnostic performance of the current criteria of the Endocrine Society, insulin-glucose ratio, C-peptide-glucose ratio, and amended ratios in terms of differentiating insulinomas.MethodsWe reviewed the medical records of patients who underwent evaluation for hypoglycemia from 2000 to 2013. Fourteen patients with histopathologically confirmed insulinoma and 18 patients without clinical evidence of insulinoma were included. The results of a prolonged fast test were analyzed according to the abovementioned criteria.ResultsFulfilling all three Endocrine Society criteria-plasma levels of glucose (24.0 (pmol/L/(mmol/L] gave the highest area under the receiver operating characteristic curve, with 93% sensitivity and 94% specificity.ConclusionFulfilling the glucose, insulin, and C-peptide criteria of the Endocrine Society guidelines exhibited the best diagnostic performance for insulinoma. Nonetheless, the insulin-glucose ratio may still have a role in the biochemical diagnosis of insulinoma.

Multi-Criteria Analysis to Prioritize Energy Sources for Ambience in Poultry Production

Directory of Open Access Journals (Sweden)

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.

Technological Criteria Technology-Environmental under a Systemic Approach: Chemistry Technology Transfer

Directory of Open Access Journals (Sweden)

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.

Return to Play After Hamstring Injuries: A Qualitative Systematic Review of Definitions and Criteria.

Science.gov (United States)

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

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

Energy Technology Data Exchange (ETDEWEB)

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.

A new generation of crystallographic validation tools for the protein data bank.

Science.gov (United States)

Read, Randy J; Adams, Paul D; Arendall, W Bryan; Brunger, Axel T; Emsley, Paul; Joosten, Robbie P; Kleywegt, Gerard J; Krissinel, Eugene B; Lütteke, Thomas; Otwinowski, Zbyszek; Perrakis, Anastassis; Richardson, Jane S; Sheffler, William H; Smith, Janet L; Tickle, Ian J; Vriend, Gert; Zwart, Peter H

2011-10-12

This report presents the conclusions of the X-ray Validation Task Force of the worldwide Protein Data Bank (PDB). The PDB has expanded massively since current criteria for validation of deposited structures were adopted, allowing a much more sophisticated understanding of all the components of macromolecular crystals. The size of the PDB creates new opportunities to validate structures by comparison with the existing database, and the now-mandatory deposition of structure factors creates new opportunities to validate the underlying diffraction data. These developments highlighted the need for a new assessment of validation criteria. The Task Force recommends that a small set of validation data be presented in an easily understood format, relative to both the full PDB and the applicable resolution class, with greater detail available to interested users. Most importantly, we recommend that referees and editors judging the quality of structural experiments have access to a concise summary of well-established quality indicators. Copyright © 2011 Elsevier Ltd. All rights reserved.

High sensitivity and specificity in proposed clinical diagnostic criteria for anti-N-methyl-D-aspartate receptor encephalitis.

Science.gov (United States)

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.

Internal Consistency, Retest Reliability, and their Implications For Personality Scale Validity

Science.gov (United States)

McCrae, Robert R.; Kurtz, John E.; Yamagata, Shinji; Terracciano, Antonio

2010-01-01

We examined data (N = 34,108) on the differential reliability and validity of facet scales from the NEO Inventories. We evaluated the extent to which (a) psychometric properties of facet scales are generalizable across ages, cultures, and methods of measurement; and (b) validity criteria are associated with different forms of reliability. Composite estimates of facet scale stability, heritability, and cross-observer validity were broadly generalizable. Two estimates of retest reliability were independent predictors of the three validity criteria; none of three estimates of internal consistency was. Available evidence suggests the same pattern of results for other personality inventories. Internal consistency of scales can be useful as a check on data quality, but appears to be of limited utility for evaluating the potential validity of developed scales, and it should not be used as a substitute for retest reliability. Further research on the nature and determinants of retest reliability is needed. PMID:20435807

Dynamic contrast-enhanced, extremity-dedicated MRI identifies synovitis changes in the follow-up of rheumatoid arthritis patients treated with rituximab

DEFF Research Database (Denmark)

Cimmino, Marco A; Parodi, Massimiliano; Zampogna, Giuseppe

2014-01-01

according to the 1987 ACR criteria were treated with a single course of RTX (2 infusions of 1000 mg, 15 days apart). MRI of the dominant hand was performed with a 0.2T extremity-dedicated machine using pre and post contrast T1 weighted SE, turbo 3D, and STIR sequences at baseline, and after 4 and 24 weeks....... MRI was analysed using the OMERACT-RAMRIS score and the dynamic contrast-enhanced (DCE-MRI) technique for wrist synovitis, which calculates the enhancement ratio as both rate of early enhancement (REE) and relative enhancement (RE). The corresponding ME and IRE parameters were calculated also through...

CisLunar Habitat Internal Architecture Design Criteria

Science.gov (United States)

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

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

Science.gov (United States)

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.

Fundamentals of critical analysis: the concept of validity and analysis essentials

Directory of Open Access Journals (Sweden)

Miguel Araujo Alonso

2012-01-01

Full Text Available Critical analysis of literature is an assessment process that allows the reader to get an idea of potential error in the results of a study, errors arising either from bias or confusion. Critical analysis attempts to establish whether the study meets expected criteria or methodological conditions. There are many checklists available that are commonly used to guide this analysis, but filling out a checklist is not tantamount to critical appraisal. Internal validity is defined as the extent to which a research finding actually represents the true relationship between exposure and outcome, considering the unique conditions in which the study was carried out. Attention must be given to the inclusion and exclusion criteria that were used, on the sampling methods, on the baseline characteristics of the patients that were enrolled in the study. External validity refers to the possibility of generalizing conclusions beyond the study sample or the study population. External validity includes population validity and ecological validity. Lastly, the article covers potential threats to external validity that must be considered when analyzing a study.

Multidimensional Diagnostic Criteria for Chronic Pain: Introduction to the ACTTION-American Pain Society Pain Taxonomy (AAPT).

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Dworkin, Robert H; Bruehl, Stephen; Fillingim, Roger B; Loeser, John D; Terman, Gregory W; Turk, Dennis C

2016-09-01

A variety of approaches have been used to develop diagnostic criteria for chronic pain. The published evidence of the reliability and validity of existing diagnostic criteria is limited, and these criteria have typically not been used in clinical practice. The availability of a widely accepted, consistently applied, and evidence-based taxonomy of diagnostic criteria would improve the quality of clinical research on chronic pain and would be of great value in clinical practice. To address the need for evidence-based diagnostic criteria for the major chronic pain conditions, the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership with the US Food and Drug Administration and the American Pain Society (APS) have collaborated on the development of the ACTTION-APS Pain Taxonomy (AAPT). AAPT provides a multidimensional framework that is applied systematically in the development of diagnostic criteria. This article (1) describes the background and rationale for AAPT; (2) presents the AAPT taxonomy and the specific conditions for which diagnostic criteria have been developed (to be published separately); (3) briefly reviews the 5 dimensions that constitute the AAPT multidimensional framework and describes the 7 accompanying articles that discuss these dimensions and other important issues involving AAPT; and (4) provides an overview of next steps, specifically, the general processes by which the initial set of diagnostic criteria (for which the evidence base has been drawn from the literature, systematic reviews, and secondary analyses of existing databases) will undergo additional assessments of reliability and validity. To address the need for evidence-based diagnostic criteria for the major chronic pain conditions, the AAPT provides a multidimensional framework that is applied systematically in the development of diagnostic criteria. The long-term objective of AAPT is to advance

Exploring DSM-5 ADHD criteria beyond young adulthood: phenomenology, psychometric properties and prevalence in a large three-decade birth cohort.

Science.gov (United States)

Vitola, E S; Bau, C H D; Salum, G A; Horta, B L; Quevedo, L; Barros, F C; Pinheiro, R T; Kieling, C; Rohde, L A; Grevet, E H

2017-03-01

There are still uncertainties on the psychometric validity of the DSM-5 attention deficit hyperactivity disorder (ADHD) criteria for its use in the adult population. We aim to describe the adult ADHD phenotype, to test the psychometric properties of the DSM-5 ADHD criteria, and to calculate the resulting prevalence in a population-based sample in their thirties. A cross-sectional evaluation using the DSM-5 ADHD criteria was carried out in 3574 individuals from the 1982 Pelotas Birth Cohort. Through receiver operator curve, latent and regression analyses, we obtained parameters on construct and discriminant validity. Still, prevalence rates were calculated for different sets of criteria. The latent analysis suggested that the adult ADHD phenotype is constituted mainly by inattentive symptoms. Also, inattention symptoms were the symptoms most associated with impairment. The best cut-off for diagnosis was four symptoms, but sensitivity and specificity for this cut-off was low. ADHD prevalence rates were 2.1% for DSM-5 ADHD criteria and 5.8% for ADHD disregarding age-of-onset criterion. The bi-dimensional ADHD structure proposed by the DSM demonstrated both construct and discriminant validity problems when used in the adult population, since inattention is a much more relevant feature in the adult phenotype. The use of the DSM-5 criteria results in a higher prevalence of ADHD when compared to those obtained by DSM-IV, and prevalence would increase almost threefold when considering current ADHD syndrome. These findings suggest a need for further refinement of the criteria for its use in the adult population.

Evaluation and construction of diagnostic criteria for inclusion body myositis

Science.gov (United States)

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

A proposal of criteria for the classification of systemic sclerosis.

Science.gov (United States)

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.

Internet Gaming Disorder and Well-Being: A Scale Validation.

Science.gov (United States)

Sarda, Elisa; Bègue, Laurent; Bry, Clémentine; Gentile, Douglas

2016-11-01

The overuse of online games is known to be inversely related to various indicators of well-being. This article validates the DSM-5 criteria of internet gaming disorder (IGD), and analyzes its links with five indicators of well-being: life satisfaction, loneliness, anxiety, depression, and academic performance in a French-speaking sample of 693 gamers. Exploratory and confirmatory factor analyses showed a one-factor structure of IGD criteria. The IGD scale showed satisfactory validity and reliability and was related in a consistent way with well-being measures. The IGD scale appears to be an appropriate measure to assess video game addiction and will contribute to increase the comparability of international research on video game addiction.

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.

Science.gov (United States)

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

Broad versus narrow traits: Conscientiousness and Honesty-Humility as predictors of academic criteria

NARCIS (Netherlands)

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

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

Science.gov (United States)

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

Expert judgment based multi-criteria decision model to address uncertainties in risk assessment of nanotechnology-enabled food products

International Nuclear Information System (INIS)

Flari, Villie; Chaudhry, Qasim; Neslo, Rabin; Cooke, Roger

2011-01-01

Currently, risk assessment of nanotechnology-enabled food products is considered difficult due to the large number of uncertainties involved. We developed an approach which could address some of the main uncertainties through the use of expert judgment. Our approach employs a multi-criteria decision model, based on probabilistic inversion that enables capturing experts’ preferences in regard to safety of nanotechnology-enabled food products, and identifying their opinions in regard to the significance of key criteria that are important in determining the safety of such products. An advantage of these sample-based techniques is that they provide out-of-sample validation and therefore a robust scientific basis. This validation in turn adds predictive power to the model developed. We achieved out-of-sample validation in two ways: (1) a portion of the expert preference data was excluded from the model’s fitting and was then predicted by the model fitted on the remaining rankings and (2) a (partially) different set of experts generated new scenarios, using the same criteria employed in the model, and ranked them; their ranks were compared with ranks predicted by the model. The degree of validation in each method was less than perfect but reasonably substantial. The validated model we applied captured and modelled experts’ preferences regarding safety of hypothetical nanotechnology-enabled food products. It appears therefore that such an approach can provide a promising route to explore further for assessing the risk of nanotechnology-enabled food products.

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

Energy Technology Data Exchange (ETDEWEB)

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.

Nine Criteria for a Measure of Scientific Output

Science.gov (United States)

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

[Reflections about the efficiency criteria for cancer treatments during marketing authorization application].

Science.gov (United States)

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.

The DSM diagnostic criteria for gender identity disorder in children.

Science.gov (United States)

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.

International consensus diagnostic criteria for neuromyelitis optica spectrum disorders

Science.gov (United States)

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

CURRENT PHARMACOTHERAPY FOR KNEE OSTEOARTHRITIS: SPECIFIC FEATURES OF SYMPTOMATIC AND DISEASE MODIFYING EFFECTS. COMMUNICATION 1. SPECIFIC FEATURES OF THE SYMPTOMATIC EFFECTS OF CURRENT DRUGS TO TREAT KNEE OSTHEOARTHRITIS

Directory of Open Access Journals (Sweden)

E. S. Tsvetkova

2015-01-01

Full Text Available Objective: to study the specific features of the symptomatic effect and tolerability of acetaminophen, glucosamine sulfate (GS, chondroitin sulfate (CS, and meloxicam in patents with knee osteoarthritis (OA. Subjects and methods. An 18-month open-label randomized prospective parallel-group trial enrolled 80 patients with knee OA who fulfilled the American College of Rheumatology criteria and signed the informed consent. They had Kellgren and Lawrence grades O-III OA with visual analogue scale pain intensity of ≥ 40 mm in the target knee, a body mass index of ≤ 35 kg/m2, and no clinical dysfunctions of vital organs and systems. The patients were randomized into 4 groups: 1 acetaminophen 2 g daily; 2 a standard GS regimen; 3 a standard CS regimen; 4 meloxicam 15 mg daily. The patients were followed up for 18 months. The effectiveness was evaluated by the WOMAC questionnaire, Leguesne index, and OMERACT-OARSI (D scenario during 8 visits. Laboratory and clinical examination as well as electrocardiography were performed. Adverse events were recorded during each visit.Results. After 4 weeks of treatment, symptomatic improvement was noted in all groups; however, the best effect was achieved by the use of meloxicam that ensured an obvious improvement in all patients. According to the OMERACT-OARSI criteria and changes in the WOMAC and Leguesne indices, the total efficacy of meloxicam was also highest. 20, 10, and 15% of the patients failed to respond to treatment in the acetaminophen, GS, and CS groups, respectively. Conclusion. The results of this trial suggest that it is expedient to use GS, CS, and meloxicam long, support the recent guidelines of the European Society for Clinical and Economic Aspects of Osteoporosis and OA (ESCEO, and can give proofs of the efficiency and safety of GS, CS, and meloxicam used in the treatment of knee OA.

Performance of Different Diagnostic Criteria for Familial Mediterranean Fever in Children with Periodic Fevers : Results from a Multicenter International Registry

NARCIS (Netherlands)

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

Method validation in pharmaceutical analysis: from theory to practical optimization

Directory of Open Access Journals (Sweden)

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

Criteria to facilitate the implementation of woman-centred care in childbirth units of Limpopo Province, South Africa (Part 2

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Maria S. Maputle

2013-05-01

Full Text Available Background: Facilitation of mutual participation, respectful and egalitarian relationship between the mother and the midwife during childbirth is a critical aspect. This article delineated the criteria that would facilitate the implementation of woman-centred care in childbirth units of the Limpopo Province in South Africa, following a concept analysis described in Part 1. Empirical referents or indicators were used to measure the concept woman-centred care and to validate its existence in reality. These empirical referents were referred to as measurable properties that further verified the concept. Objective: The objective of this article was to formulate criteria that would facilitate implementation of woman-centred care in childbirth units of Limpopo Province in South Africa. Method: Criteria to facilitate the implementation of woman-centred care were formulated by the gathering of information about the topic under review and the use of resources to define the key elements of the criteria which were integrated into the Batho Pele principles. The criteria were then validated by selecting with a vested interest in the successful development and implementation of the criteria. Results: Criteria were formulated to facilitate the implementation of woman-centred care that was integrated within the framework of Batho Pele principles. Conclusion: These formulated criteria for woman-centred care will be used as an institutional self-evaluation tool to enhance implementation of the Batho Pele principles in childbirth units. These criteria will give direction and provide guidelines for the performance of midwifery staff and will also help supervisors to guide staff to improve performance.

Criteria to facilitate the implementation of woman-centred care in childbirth units of Limpopo Province, South Africa (Part 2

Directory of Open Access Journals (Sweden)

Maria S. Maputle

2013-05-01

Full Text Available Background: Facilitation of mutual participation, respectful and egalitarian relationship between the mother and the midwife during childbirth is a critical aspect. This article delineated the criteria that would facilitate the implementation of woman-centred care in childbirth units of the Limpopo Province in South Africa, following a concept analysis described in Part 1. Empirical referents or indicators were used to measure the concept woman-centred care and to validate its existence in reality. These empirical referents were referred to as measurable properties that further verified the concept. Objective: The objective of this article was to formulate criteria that would facilitate implementation of woman-centred care in childbirth units of Limpopo Province in South Africa.Method: Criteria to facilitate the implementation of woman-centred care were formulated by the gathering of information about the topic under review and the use of resources to define the key elements of the criteria which were integrated into the Batho Pele principles. The criteria were then validated by selecting with a vested interest in the successful development and implementation of the criteria. Results: Criteria were formulated to facilitate the implementation of woman-centred care that was integrated within the framework of Batho Pele principles. Conclusion: These formulated criteria for woman-centred care will be used as an institutional self-evaluation tool to enhance implementation of the Batho Pele principles in childbirth units. These criteria will give direction and provide guidelines for the performance of midwifery staff and will also help supervisors to guide staff to improve performance.

Hydraulic Design Criteria for Spacer Grids of Nuclear Fuel Element

International Nuclear Information System (INIS)

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

Gout Classification Criteria: Update and Implications

Science.gov (United States)

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

Longitudinal diagnostic efficiency of DSM-IV criteria for obsessive-compulsive personality disorder: a 2-year prospective study.

Science.gov (United States)

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.

How should we revise diagnostic criteria for substance use disorders in the DSM-V?

Science.gov (United States)

Martin, Christopher S; Chung, Tammy; Langenbucher, James W

2008-08-01

This article reviews literature on the validity and performance characteristics of the Diagnostic and Statistical Manual of Mental Disorders (4th ed.; DSM-IV; American Psychiatric Association, 1994) diagnostic criteria for substance use disorders (SUDs) and recommends changes in these criteria that should be considered for the next edition of the DSM (DSM-V). Substantial data indicate that DSM-IV substance abuse and substance dependence are not distinct categories and that SUD criteria are best modeled as reflecting a unidimensional continuum of substance-problem severity. The conceptually and empirically problematic substance abuse diagnosis should be abandoned in the DSM-V, with substance dependence defined by a single set of criteria. Data also indicate that various individual SUD criteria should be revised, dropped, or considered for inclusion in the DSM-V. The DSM-V should provide a framework that allows the integration of categorical and dimensional approaches to diagnosis. Important areas for further research are noted. Copyright (c) 2008 APA, all rights reserved.

Measuring production loss due to health and work environment problems: construct validity and implications.

Science.gov (United States)

Karlsson, Malin Lohela; Bergström, Gunnar; Björklund, Christina; Hagberg, Jan; Jensen, Irene

2013-12-01

The aim was to validate two measures of production loss, health-related and work environment-related production loss, concerning their associations with health status and work environment factors. Validity was assessed by evaluating the construct validity. Health problems related and work environment-related problems (or factors) were included in separate analyses and evaluated regarding the significant difference in proportion of explained variation (R) of production loss. health problems production loss was not found to fulfill the criteria for convergent validity in this study; however, the measure of work environment-related production loss did fulfill the criteria that were set up. The measure of work environment-related production loss can be used to screen for production loss due to work environment problems as well as an outcome measure when evaluating the effect of organizational interventions.

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

Science.gov (United States)

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

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

Science.gov (United States)

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.

A generic approach for steel containment vessel success criteria for severe accident loads

International Nuclear Information System (INIS)

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)

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

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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.

Application of EU guidelines for the validation of screening methods for veterinary drugs

NARCIS (Netherlands)

Stolker, A.A.M.

2012-01-01

Commission Decision (CD) 2002/657/EC describes detailed rules for method validation within the framework of residue monitoring programmes. The approach described in this CD is based on criteria. For (qualitative) screening methods, the most important criteria is that the CCß has to be below any

Hermeneutic Haunting: E. D. Hirsch, Jr. and the Ghost of Interpretive Validity

Science.gov (United States)

O'Neill, Linda

2011-01-01

This article applies criteria for validity in interpretation to Eric Donald Hirsch, Jr.'s interpretations of John Dewey. Specifically, three criteria that Hirsch, himself, established in his earlier work are used to evaluate Hirsch's interpretation of John Dewey as a member of a class (romantics) who embraced a naive naturalism (trait) more often…

The Impact of Overreporting on MMPI-2-RF Substantive Scale Score Validity

Science.gov (United States)

Burchett, Danielle L.; Ben-Porath, Yossef S.

2010-01-01

This study examined the impact of overreporting on the validity of Minnesota Multiphasic Personality Inventory-2-Restructured Form (MMPI-2-RF) substantive scale scores by comparing correlations with relevant external criteria (i.e., validity coefficients) of individuals who completed the instrument under instructions to (a) feign psychopathology…

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

Science.gov (United States)

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.

How to Use the ADI-R for Classifying Autism Spectrum Disorders? Psychometric Properties of Criteria from the Literature in 1,204 Dutch Children

Science.gov (United States)

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…

To Make Good Decision: A Group DSS for Multiple Criteria Alternative Rank and Selection

Directory of Open Access Journals (Sweden)

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.

Expanding the taxonomy of the diagnostic criteria for temporomandibular disorders.

Science.gov (United States)

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.

Validating SPICES as a Screening Tool for Frailty Risks among Hospitalized Older Adults

Science.gov (United States)

Aronow, Harriet Udin; Borenstein, Jeff; Haus, Flora; Braunstein, Glenn D.; Bolton, Linda Burnes

2014-01-01

Older patients are vulnerable to adverse hospital events related to frailty. SPICES, a common screening protocol to identify risk factors in older patients, alerts nurses to initiate care plans to reduce the probability of patient harm. However, there is little published validating the association between SPICES and measures of frailty and adverse outcomes. This paper used data from a prospective cohort study on frailty among 174 older adult inpatients to validate SPICES. Almost all patients met one or more SPICES criteria. The sum of SPICES was significantly correlated with age and other well-validated assessments for vulnerability, comorbid conditions, and depression. Individuals meeting two or more SPICES criteria had a risk of adverse hospital events three times greater than individuals with either no or one criterion. Results suggest that as a screening tool used within 24 hours of admission, SPICES is both valid and predictive of adverse events. PMID:24876954

When Progressive Disease Does Not Mean Treatment Failure: Reconsidering the Criteria for Progression

Science.gov (United States)

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

IT Security Standards and Legal Metrology - Transfer and Validation

Science.gov (United States)

Thiel, F.; Hartmann, V.; Grottker, U.; Richter, D.

2014-08-01

Legal Metrology's requirements can be transferred into the IT security domain applying a generic set of standardized rules provided by the Common Criteria (ISO/IEC 15408). We will outline the transfer and cross validation of such an approach. As an example serves the integration of Legal Metrology's requirements into a recently developed Common Criteria based Protection Profile for a Smart Meter Gateway designed under the leadership of the Germany's Federal Office for Information Security. The requirements on utility meters laid down in the Measuring Instruments Directive (MID) are incorporated. A verification approach to check for meeting Legal Metrology's requirements by their interpretation through Common Criteria's generic requirements is also presented.

An index with improved diagnostic accuracy for the diagnosis of Crohn's disease derived from the Lennard-Jones criteria.

Science.gov (United States)

Reinisch, S; Schweiger, K; Pablik, E; Collet-Fenetrier, B; Peyrin-Biroulet, L; Alfaro, I; Panés, J; Moayyedi, P; Reinisch, W

2016-09-01

The Lennard-Jones criteria are considered the gold standard for diagnosing Crohn's disease (CD) and include the items granuloma, macroscopic discontinuity, transmural inflammation, fibrosis, lymphoid aggregates and discontinuous inflammation on histology. The criteria have never been subjected to a formal validation process. To develop a validated and improved diagnostic index based on the items of Lennard-Jones criteria. Included were 328 adult patients with long-standing CD (median disease duration 10 years) from three centres and classified as 'established', 'probable' or 'non-CD' by Lennard-Jones criteria at time of diagnosis. Controls were patients with ulcerative colitis (n = 170). The performance of each of the six diagnostic items of Lennard-Jones criteria was modelled by logistic regression and a new index based on stepwise backward selection and cut-offs was developed. The diagnostic value of the new index was analysed by comparing sensitivity, specificity and accuracy vs. Lennard-Jones criteria. By Lennard-Jones criteria 49% (n = 162) of CD patients would have been diagnosed as 'non-CD' at time of diagnosis (sensitivity/specificity/accuracy, 'established' CD: 0.34/0.99/0.67; 'probable' CD: 0.51/0.95/0.73). A new index was derived from granuloma, fibrosis, transmural inflammation and macroscopic discontinuity, but excluded lymphoid aggregates and discontinuous inflammation on histology. Our index provided improved diagnostic accuracy for 'established' and 'probable' CD (sensitivity/specificity/accuracy, 'established' CD: 0.45/1/0.72; 'probable' CD: 0.8/0.85/0.82), including the subgroup isolated colonic CD ('probable' CD, new index: 0.73/0.85/0.79; Lennard-Jones criteria: 0.43/0.95/0.69). We developed an index based on items of Lennard-Jones criteria providing improved diagnostic accuracy for the differential diagnosis between CD and UC. © 2016 John Wiley & Sons Ltd.

A model for assessing the degree of importance of ergonomics criteria to human machine interface

Energy Technology Data Exchange (ETDEWEB)

Araujo, Cesar Ribeiro de; Domech More, Jesus [Universidade Estacio de Sa do Rio de Janeiro, RJ (Brazil). Mestrado em Desenvolvimento Empresarial - MADE]. E-mail: cesararaujobr@yahoo.com.br; jesus.more@estacio.br; Silva, Aretha Felix Thomaz da [Coordenacao dos Programas de Pos-graduacao de Engenharia (COPPE/UFRJ), Rio de Janeiro, RJ (Brazil). Programa de Engenharia Civil. Sistemas Computacionais Orientados a Industria do Petroleo]. E-mail: aretha@coc.ufrj.br

2007-07-01

This paper intends to show a model to help us to incorporate ergonomics criteria into the usability of the human computer interface (HCI). The techniques based on fuzzy set theory are appropriate tools for the treatment of subjective and vague concepts that are inherent to usability for the HCI. The application consists of analysis concepts. This approach allows the use of natural language expressions of importance in ergonomics criteria estimation. The above-mentioned model shows the degree of importance of the ergonomics criteria present in the software interface used in the medical area. In this work, as entry data, the system developer opinions are used and as a result we had the hierarchy of 18 ergonomic criteria. The ergonomic criteria are those already validated by the market, which are linked to the ErgoList checklists. The fuzzy model created will allow knowing the most important criteria to health governmental companies. Its Information Technology (IT) professionals will concentrate efforts when treating the usability of the software interface and its systems. (author)

A model for assessing the degree of importance of ergonomics criteria to human machine interface

International Nuclear Information System (INIS)

Araujo, Cesar Ribeiro de; Domech More, Jesus; Silva, Aretha Felix Thomaz da

2007-01-01

This paper intends to show a model to help us to incorporate ergonomics criteria into the usability of the human computer interface (HCI). The techniques based on fuzzy set theory are appropriate tools for the treatment of subjective and vague concepts that are inherent to usability for the HCI. The application consists of analysis concepts. This approach allows the use of natural language expressions of importance in ergonomics criteria estimation. The above-mentioned model shows the degree of importance of the ergonomics criteria present in the software interface used in the medical area. In this work, as entry data, the system developer opinions are used and as a result we had the hierarchy of 18 ergonomic criteria. The ergonomic criteria are those already validated by the market, which are linked to the ErgoList checklists. The fuzzy model created will allow knowing the most important criteria to health governmental companies. Its Information Technology (IT) professionals will concentrate efforts when treating the usability of the software interface and its systems. (author)

Prevalence of DSM-IV disorders in a population-based sample of 5- to 8-year-old children : the impact of impairment criteria

NARCIS (Netherlands)

Rijlaarsdam, Jolien; Stevens, Gonneke W J M; van der Ende, Jan; Hofman, Albert; Jaddoe, Vincent W V; Verhulst, Frank C.; Tiemeier, Henning

2015-01-01

This study determined the impact of impairment criteria on the prevalence and patterns of comorbidity of child DSM-IV disorders. The validity of these impairment criteria was tested against different measures of mental health care referral and utilization. We interviewed parents of 1,154 children

Prevalence of DSM-IV disorders in a population-based sample of 5- to 8-year-old children: the impact of impairment criteria

NARCIS (Netherlands)

J. Rijlaarsdam (Jolien); G. Stevens (Gonneke); J. van der Ende (Jan); A. Hofman (Albert); V.W.V. Jaddoe (Vincent); F.C. Verhulst (Frank); H.W. Tiemeier (Henning)

2015-01-01

textabstractThis study determined the impact of impairment criteria on the prevalence and patterns of comorbidity of child DSM-IV disorders. The validity of these impairment criteria was tested against different measures of mental health care referral and utilization. We interviewed parents of 1,154

What criteria do consumer health librarians use to develop library collections? a phenomenological study.

Science.gov (United States)

Papadakos, Janet; Trang, Aileen; Wiljer, David; Cipolat Mis, Chiara; Cyr, Alaina; Friedman, Audrey Jusko; Mazzocut, Mauro; Snow, Michelle; Raivich, Valeria; Catton, Pamela

2014-04-01

The criteria for determining whether resources are included in consumer health library collections are summarized in institutional collection development policies (CDPs). Evidence suggests that CDPs do not adequately capture all of these criteria. The aim of this study was to describe the resource review experience of librarians and compare it to what is described in CDPs. A phenomenological approach was used to explore and describe the process. Four consumer health librarians independently evaluated cancer-related consumer health resources and described their review process during a semi-structured telephone interview. Afterward, these librarians completed online questionnaires about their approaches to collection development. CDPs from participating libraries, interview transcripts, and questionnaire data were analyzed. Researchers summarized the findings, and participating librarians reviewed results for validation. Librarians all utilized similar criteria, as documented in their CDPs; however, of thirteen criteria described in the study, only four were documented in CDPs. CDPs for consumer health libraries may be missing important criteria that are considered integral parts of the collection development process. A better understanding of the criteria and contextual factors involved in the collection development process can assist with establishing high-quality consumer health library collections.

What criteria do consumer health librarians use to develop library collections? a phenomenological study*

Science.gov (United States)

Papadakos, Janet; Trang, Aileen; Wiljer, David; Mis, Chiara Cipolat; Cyr, Alaina; Friedman, Audrey Jusko; Mazzocut, Mauro; Snow, Michelle; Raivich, Valeria; Catton, Pamela

2014-01-01

Objectives: The criteria for determining whether resources are included in consumer health library collections are summarized in institutional collection development policies (CDPs). Evidence suggests that CDPs do not adequately capture all of these criteria. The aim of this study was to describe the resource review experience of librarians and compare it to what is described in CDPs. Methods: A phenomenological approach was used to explore and describe the process. Four consumer health librarians independently evaluated cancer-related consumer health resources and described their review process during a semi-structured telephone interview. Afterward, these librarians completed online questionnaires about their approaches to collection development. CDPs from participating libraries, interview transcripts, and questionnaire data were analyzed. Researchers summarized the findings, and participating librarians reviewed results for validation. Results: Librarians all utilized similar criteria, as documented in their CDPs; however, of thirteen criteria described in the study, only four were documented in CDPs. Conclusions: CDPs for consumer health libraries may be missing important criteria that are considered integral parts of the collection development process. Implications: A better understanding of the criteria and contextual factors involved in the collection development process can assist with establishing high-quality consumer health library collections. PMID:24860261

Criteria for the prioritization of public health interventions for climate-sensitive vector-borne diseases in Quebec.

Directory of Open Access Journals (Sweden)

Valerie Hongoh

Full Text Available Prioritizing resources for optimal responses to an ever growing list of existing and emerging infectious diseases represents an important challenge to public health. In the context of climate change, there is increasing anticipated variability in the occurrence of infectious diseases, notably climate-sensitive vector-borne diseases. An essential step in prioritizing efforts is to identify what considerations and concerns to take into account to guide decisions and thus set disease priorities. This study was designed to perform a comprehensive review of criteria for vector-borne disease prioritization, assess their applicability in a context of climate change with a diverse cross-section of stakeholders in order to produce a baseline list of considerations to use in this decision-making context. Differences in stakeholder choices were examined with regards to prioritization of these criteria for research, surveillance and disease prevention and control objectives. A preliminary list of criteria was identified following a review of the literature. Discussions with stakeholders were held to consolidate and validate this list of criteria and examine their effects on disease prioritization. After this validation phase, a total of 21 criteria were retained. A pilot vector-borne disease prioritization exercise was conducted using PROMETHEE to examine the effects of the retained criteria on prioritization in different intervention domains. Overall, concerns expressed by stakeholders for prioritization were well aligned with categories of criteria identified in previous prioritization studies. Weighting by category was consistent between stakeholders overall, though some significant differences were found between public health and non-public health stakeholders. From this exercise, a general model for climate-sensitive vector-borne disease prioritization has been developed that can be used as a starting point for further public health prioritization

Criteria for the prioritization of public health interventions for climate-sensitive vector-borne diseases in Quebec.

Science.gov (United States)

Hongoh, Valerie; Gosselin, Pierre; Michel, Pascal; Ravel, André; Waaub, Jean-Philippe; Campagna, Céline; Samoura, Karim

2017-01-01

Prioritizing resources for optimal responses to an ever growing list of existing and emerging infectious diseases represents an important challenge to public health. In the context of climate change, there is increasing anticipated variability in the occurrence of infectious diseases, notably climate-sensitive vector-borne diseases. An essential step in prioritizing efforts is to identify what considerations and concerns to take into account to guide decisions and thus set disease priorities. This study was designed to perform a comprehensive review of criteria for vector-borne disease prioritization, assess their applicability in a context of climate change with a diverse cross-section of stakeholders in order to produce a baseline list of considerations to use in this decision-making context. Differences in stakeholder choices were examined with regards to prioritization of these criteria for research, surveillance and disease prevention and control objectives. A preliminary list of criteria was identified following a review of the literature. Discussions with stakeholders were held to consolidate and validate this list of criteria and examine their effects on disease prioritization. After this validation phase, a total of 21 criteria were retained. A pilot vector-borne disease prioritization exercise was conducted using PROMETHEE to examine the effects of the retained criteria on prioritization in different intervention domains. Overall, concerns expressed by stakeholders for prioritization were well aligned with categories of criteria identified in previous prioritization studies. Weighting by category was consistent between stakeholders overall, though some significant differences were found between public health and non-public health stakeholders. From this exercise, a general model for climate-sensitive vector-borne disease prioritization has been developed that can be used as a starting point for further public health prioritization exercises relating to

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

African Journals Online (AJOL)

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 ...

Modelling of the activity system - development of an evaluation method for integrated system validation

International Nuclear Information System (INIS)

Norros, Leena; Savioja, Paula

2004-01-01

In this paper we present our recent research which focuses on creating an evaluation method for human-system interfaces of complex systems. The method is aimed for use in the validation of modernised nuclear power plant (NPP) control rooms, and other complex systems with high reliability requirements. The task in validation is to determine whether the human-system functions safely and effectively. This question can be operationalized to the selection of relevant operational features and their appropriate acceptance criteria. Thus, there is a need to ensure that the results of the evaluation can be generalized so that they serve the purpose of integrated system validation. The definition of the appropriate acceptance criteria provides basis for the judgement of the appropriateness of the performance of the system. We propose that the operational situations and the acceptance criteria should be defined based on modelling of the NPP operation that is comprehended as an activity system. We developed a new core-tasks modelling framework. It is a formative modelling approach that combines causal, functional and understanding explanations of system performance. In this paper we reason how modelling can be used as a medium to determine the validity of the emerging control room system. (Author)

Development and validation of a game addiction scale

NARCIS (Netherlands)

Lemmens, J.S.; Valkenburg, P.M.; Peter, J.

2008-01-01

The aim of this study was to develop and validate a scale to measure computer and videogame addiction. Inspired by earlier theories and research on game and internet addiction, we created 21 items to measure seven criteria for game addiction (i.e., salience, tolerance, mood modification, relapse,

Guidelines, Criteria, and Rules of Thumb for Evaluating Normed and Standardized Assessment Instruments in Psychology.

Science.gov (United States)

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)

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

Science.gov (United States)

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.

Validity and Reliability of Published Comprehensive Theory of Mind Tests for Normal Preschool Children: A Systematic Review

Directory of Open Access Journals (Sweden)

Seyyede Zohreh Ziatabar Ahmadi

2015-12-01

Full Text Available Objective: Theory of mind (ToM or mindreading is an aspect of social cognition that evaluates mental states and beliefs of oneself and others. Validity and reliability are very important criteria when evaluating standard tests; and without them, these tests are not usable. The aim of this study was to systematically review the validity and reliability of published English comprehensive ToM tests developed for normal preschool children.Method: We searched MEDLINE (PubMed interface, Web of Science, Science direct, PsycINFO, and also evidence base Medicine (The Cochrane Library databases from 1990 to June 2015. Search strategy was Latin transcription of ‘Theory of Mind’ AND test AND children. Also, we manually studied the reference lists of all final searched articles and carried out a search of their references. Inclusion criteria were as follows: Valid and reliable diagnostic ToM tests published from 1990 to June 2015 for normal preschool children; and exclusion criteria were as follows: the studies that only used ToM tests and single tasks (false belief tasks for ToM assessment and/or had no description about structure, validity or reliability of their tests. Methodological quality of the selected articles was assessed using the Critical Appraisal Skills Programme (CASP.Result: In primary searching, we found 1237 articles in total databases. After removing duplicates and applying all inclusion and exclusion criteria, we selected 11 tests for this systematic review. Conclusion: There were a few valid, reliable and comprehensive ToM tests for normal preschool children. However, we had limitations concerning the included articles. The defined ToM tests were different in populations, tasks, mode of presentations, scoring, mode of responses, times and other variables. Also, they had various validities and reliabilities. Therefore, it is recommended that the researchers and clinicians select the ToM tests according to their psychometric

Assessment of Different Metal Screw Joint Parameters by Using Multiple Criteria Analysis Methods

Directory of Open Access Journals (Sweden)

Audrius Čereška

2018-05-01

Full Text Available This study compares screw joints made of different materials, including screws of different diameters. For that purpose, 8, 10, 12, 14, 16 mm diameter steel screws and various parts made of aluminum (Al, steel (Stl, bronze (Brz, cast iron (CI, copper (Cu and brass (Br are considered. Multiple criteria decision making (MCDM methods such as evaluation based on distance from average solution (EDAS, simple additive weighting (SAW, technique for order of preference by similarity to ideal solution (TOPSIS and complex proportional assessment (COPRAS are utilized to assess reliability of screw joints also considering cost issues. The entropy, criterion impact loss (CILOS and integrated determination of objective criteria weights (IDOCRIW methods are utilized to assess weights of decision criteria and find the best design alternative. Numerical results confirm the validity of the proposed approach.

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

Science.gov (United States)

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.

Clinical relevance of the proposed sexual addiction diagnostic criteria: relation to the Sexual Addiction Screening Test-Revised.

Science.gov (United States)

Carnes, Patrick J; Hopkins, Tiffany A; Green, Bradley A

2014-01-01

The present article examines and compares the various diagnostic rubrics proposed to codify symptoms of sexual addiction, and then briefly summarizes the ongoing controversy on whether sexual addiction is a valid construct. Using the diagnostic criteria proposed by , the prevalence rate of each criterion is examined in terms of scores on the Sexual Addiction Screening Test-Revised scales (). Differences in diagnostic criteria endorsement associated with sex, sexual orientation, and setting were also explored. Results from a clinical sample of men and women seeking treatment for sexual addiction demonstrated clinical relevance of the criteria, in that all but 3 criteria are endorsed at more than 50% of participants screening positive for sexual addiction on the Sexual Addiction Screening Test-Revised. Sex differences were also noted for endorsement rates of several of the criteria. Finally, several proposed criteria may pose a higher clinical threshold and thus be utilized by clinicians to identify patients with increased pathology. Results are discussed in the context of existing diagnostic frameworks across etiological perspectives.

Evaluation of criteria for clinical control in a prospective, international, multicenter study of patients with COPD

DEFF Research Database (Denmark)

Miravitlles, Marc; Sliwinski, Pawel; Rhee, Chin Kook

2018-01-01

BACKGROUND: The concept of clinical control in COPD has been developed to help in treatment decisions, but it requires validation in prospective studies. METHOD: This international, multicenter, prospective study aimed to validate the concept of control in COPD [control = stability (no...... exacerbations or impairment in CAT scores) + low impact (low level of symptoms)]. Data from the screening visit was used to: investigate the level of control, compare characteristics of patients according to the control status, and perform a sensitivity analysis of the levels of control using either clinical...... criteria or questionnaires (COPD Assessment Test -CAT- or Clinical COPD Questionnaire -CCQ-). RESULTS: A total of 314 patients were analysed, mean age was 68.5 years and mean FEV1 was 52.6% of predicted. According to the prespecified criteria 21% of patients were classified as controlled, all of them...

A combined model based on spleen stiffness measurement and Baveno VI criteria to rule out high risk varices in advanced chronic liver disease.

Science.gov (United States)

Colecchia, Antonio; Ravaioli, Federico; Marasco, Giovanni; Colli, Agostino; Dajti, Elton; Biase, Annarita Di; Reggiani, Maria Letizia Bacchi; Berzigotti, Annalisa; Pinzani, Massimo; Festi, Davide

2018-05-02

Recently, Baveno VI guidelines suggested that esophagogastroduodenoscopy (EGD) can be avoided in patients with cACLD who have a liver stiffness measurement (LSM) 150,000/mm 3 . We aimed to: assess the performance of spleen stiffness measurement (SSM) in ruling out patients with high-risk varices (HRV); validate Baveno VI criteria in a large population and assess how the sequential use of Baveno VI criteria and SSM could safely avoid the need for endoscopy. We retrospectively analysed 498 cACLD patients who had undergone LSM/SSM by transient elastography (TE) (Fibroscan®), platelet count and EGDs from 2012 to 2016 referred to our tertiary centre. The new combined model was validated internally by a split-validation method, and externally in a prospective multicentre cohort of 115 patients. SSM, LSM, platelet count and Child-Pugh-B were independent predictors of HRV. Applying the newly identified SSM cut-off (≤46 kPa) or Baveno VI criteria, 35.8% and 21.7% of patients in the internal validation cohort could have avoided EGD, with HRV being missed in only 2% in both cases. The combination of SSM with Baveno VI criteria would have led to additionally avoiding 22.5% of EGDs, reaching a final value of 43.8% spared EGDs, with <5% missed HRV. Results were confirmed in the prospective external validation cohort, as the combined Baveno VI/SSM≤46 Model would have safely spared (0 HRV missed) 37.4% of EGDs, compared to 16.5% avoiding Baveno VI Criteria only. A non-invasive prediction model combining SSM with Baveno VI criteria may be useful to rule out HRV and could make it possible to avoid a significantly larger number of unnecessary EGDs compared to Baveno VI criteria only. Spleen stiffness measurement (SSM) assessed by TE, the most widely used electrographic technique, is a non-invasive technique that can help the physician to better stratify the degree of portal hypertension and the risk of oesophageal varices in patients with cACLD. Performing SSM together with LSM

Is salivary gland ultrasonography a useful tool in Sjögren's syndrome? A systematic review.

Science.gov (United States)

Jousse-Joulin, Sandrine; Milic, Vera; Jonsson, Malin V; Plagou, Athena; Theander, Elke; Luciano, Nicoletta; Rachele, Pascale; Baldini, Chiara; Bootsma, Hendrika; Vissink, Arjan; Hocevar, Alojzija; De Vita, Salvatore; Tzioufas, Athanasios G; Alavi, Zarin; Bowman, Simon J; Devauchelle-Pensec, Valerie

2016-05-01

Ultrasonography (US) is a sensitive tool in the diagnosis of major salivary gland abnormalities in primary Sjögren's syndrome (pSS). The aim of this systematic review was to assess the metric properties of this technique. PUBMED and EMBASE databases were searched. All publications between January 1988 and January 2013 were considered. Data were extracted from the articles meeting the inclusion criteria according to US definition of salivary gland scoring system and metric properties studied. The type and number of glands tested, study design and metric properties according to OMERACT filter (truth, discrimination, feasibility) were assessed. Of 167 publications identified initially with PUBMED and EMBASE, 31 met the inclusion criteria. The number of pSS patients varied among the studies from 16 to 140. The diagnosis of pSS was in line in most of the cases with the American-European Consensus Group (AECG) classification criteria for Sjögren's syndrome. The US examination was performed in suspected pSS only in studies in which the sensitivity ranged from 45.8 to 91.6% and specificity from 73 to 98.1%. There was heterogeneity in regard to the definition of US in B-mode and few studies used US in colour Doppler. Few studies reported reliability of US and sensitivity to change in pSS. US is a valuable tool for detecting salivary gland abnormalities in pSS. Its reliability has been poorly investigated and there is considerable variation in the definition of US abnormalities. Further studies are required to validate and standardize the US definition of salivary gland in pSS. © The Author 2015. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

NWTS program criteria for mined geologic disposal of nuclear wasite: site performance criteria

International Nuclear Information System (INIS)

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

Summary Findings of a Systematic Literature Review of the Ultrasound Assessment of Bone Erosions in Rheumatoid Arthritis

DEFF Research Database (Denmark)

Szkudlarek, Marcin; Terslev, Lene; Wakefield, Richard J

2016-01-01

OBJECTIVE: Bone erosions in rheumatoid arthritis (RA) have been studied in an increasing amount of research. Both earlier and present classification criteria of RA contain erosions as a significant classification component. Ultrasound (US) can detect bone changes in accessible surfaces. Therefore...... (5 papers). Reliability of assessment was presented in 20 papers and sensitivity to change in 11 papers. CONCLUSION: This paper presents results of a systematic literature review of bone erosion assessment in RA with US. The survey suggests that US can be a helpful adjunct to the existing methods...... of imaging bone erosions in RA. It analyzes definitions, scoring systems, used comparators, and elements of the OMERACT filter. It also presents recommendations for a future research agenda based on the results of the review....

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

DEFF Research Database (Denmark)

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...

[Validation of the IBS-SSS].

Science.gov (United States)

Betz, C; Mannsdörfer, K; Bischoff, S C

2013-10-01

Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder characterised by abdominal pain, associated with stool abnormalities and changes in stool consistency. Diagnosis of IBS is based on characteristic symptoms and exclusion of other gastrointestinal diseases. A number of questionnaires exist to assist diagnosis and assessment of severity of the disease. One of these is the irritable bowel syndrome - severity scoring system (IBS-SSS). The IBS-SSS was validated 1997 in its English version. In the present study, the IBS-SSS has been validated in German language. To do this, a cohort of 60 patients with IBS according to the Rome III criteria, was compared with a control group of healthy individuals (n = 38). We studied sensitivity and reproducibility of the score, as well as the sensitivity to detect changes of symptom severity. The results of the German validation largely reflect the results of the English validation. The German version of the IBS-SSS is also a valid, meaningful and reproducible questionnaire with a high sensitivity to assess changes in symptom severity, especially in IBS patients with moderate symptoms. It is unclear if the IBS-SSS is also a valid questionnaire in IBS patients with severe symptoms because this group of patients was not studied. © Georg Thieme Verlag KG Stuttgart · New York.

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

Science.gov (United States)

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…

A GIS-based extended fuzzy multi-criteria evaluation for landslide susceptibility mapping.

Science.gov (United States)

Feizizadeh, Bakhtiar; Shadman Roodposhti, Majid; Jankowski, Piotr; Blaschke, Thomas

2014-12-01

Landslide susceptibility mapping (LSM) is making increasing use of GIS-based spatial analysis in combination with multi-criteria evaluation (MCE) methods. We have developed a new multi-criteria decision analysis (MCDA) method for LSM and applied it to the Izeh River basin in south-western Iran. Our method is based on fuzzy membership functions (FMFs) derived from GIS analysis. It makes use of nine causal landslide factors identified by local landslide experts. Fuzzy set theory was first integrated with an analytical hierarchy process (AHP) in order to use pairwise comparisons to compare LSM criteria for ranking purposes. FMFs were then applied in order to determine the criteria weights to be used in the development of a landslide susceptibility map. Finally, a landslide inventory database was used to validate the LSM map by comparing it with known landslides within the study area. Results indicated that the integration of fuzzy set theory with AHP produced significantly improved accuracies and a high level of reliability in the resulting landslide susceptibility map. Approximately 53% of known landslides within our study area fell within zones classified as having "very high susceptibility", with the further 31% falling into zones classified as having "high susceptibility".

Development and demonstration of a validation methodology for vehicle lateral dynamics simulation models

Energy Technology Data Exchange (ETDEWEB)

Kutluay, Emir

2013-02-01

In this thesis a validation methodology to be used in the assessment of the vehicle dynamics simulation models is presented. Simulation of vehicle dynamics is used to estimate the dynamic responses of existing or proposed vehicles and has a wide array of applications in the development of vehicle technologies. Although simulation environments, measurement tools and mathematical theories on vehicle dynamics are well established, the methodical link between the experimental test data and validity analysis of the simulation model is still lacking. The developed validation paradigm has a top-down approach to the problem. It is ascertained that vehicle dynamics simulation models can only be validated using test maneuvers although they are aimed for real world maneuvers. Test maneuvers are determined according to the requirements of the real event at the start of the model development project and data handling techniques, validation metrics and criteria are declared for each of the selected maneuvers. If the simulation results satisfy these criteria, then the simulation is deemed ''not invalid''. If the simulation model fails to meet the criteria, the model is deemed invalid, and model iteration should be performed. The results are analyzed to determine if the results indicate a modeling error or a modeling inadequacy; and if a conditional validity in terms of system variables can be defined. Three test cases are used to demonstrate the application of the methodology. The developed methodology successfully identified the shortcomings of the tested simulation model, and defined the limits of application. The tested simulation model is found to be acceptable but valid only in a certain dynamical range. Several insights for the deficiencies of the model are reported in the analysis but the iteration step of the methodology is not demonstrated. Utilizing the proposed methodology will help to achieve more time and cost efficient simulation projects with

Waste Isolation Pilot Plant design validation: Final report

International Nuclear Information System (INIS)

1986-10-01

This report provides documentation of actual underground conditions encountered as they relate to the design criteria, design bases, and design configurations for the reference design of the underground openings. It includes a selection of the more essential data collected during the design validation effort and an interpretation of these data

Human Factors methods concerning integrated validation of nuclear power plant control rooms; Metodutveckling foer integrerad validering

Energy Technology Data Exchange (ETDEWEB)

Oskarsson, Per-Anders; Johansson, Bjoern J.E.; Gonzalez, Natalia (Swedish Defence Research Agency, Information Systems, Linkoeping (Sweden))

2010-02-15

The frame of reference for this work was existing recommendations and instructions from the NPP area, experiences from the review of the Turbic Validation and experiences from system validations performed at the Swedish Armed Forces, e.g. concerning military control rooms and fighter pilots. These enterprises are characterized by complex systems in extreme environments, often with high risks, where human error can lead to serious consequences. A focus group has been performed with representatives responsible for Human Factors issues from all Swedish NPP:s. The questions that were discussed were, among other things, for whom an integrated validation (IV) is performed and its purpose, what should be included in an IV, the comparison with baseline measures, the design process, the role of SSM, which methods of measurement should be used, and how the methods are affected of changes in the control room. The report brings different questions to discussion concerning the validation process. Supplementary methods of measurement for integrated validation are discussed, e.g. dynamic, psychophysiological, and qualitative methods for identification of problems. Supplementary methods for statistical analysis are presented. The study points out a number of deficiencies in the validation process, e.g. the need of common guidelines for validation and design, criteria for different types of measurements, clarification of the role of SSM, and recommendations for the responsibility of external participants in the validation process. The authors propose 12 measures for taking care of the identified problems

Structural criteria for extreme dynamic internal pressure loadings of vessels and closure heads

International Nuclear Information System (INIS)

Bitner, J.L.

1985-01-01

The criteria protect against tensile plastic instability and local ductile rupture failure modes. To minimize the number of critical areas that may need more rigorous analytical methods, a screening criterion for limiting the membrane, bending and local stresses is defined. The stresses for this criterion are calculated from either simple and economical elastic dynamic or equivalent static methods. For the critical areas that remain, a strain-based criterion for strains derived from dynamic, inelastic methods is given. To assure that the criteria are properly applied, guidelines are outlined for controlling methods for deriving stresses and strains, for selecting appropriate material properties and for addressing specific dominating parameters that affect the validity of the analysis. The application of the criteria to a complex liquid metal fast breeder reactor vessel and closure head and the subsequent experimental verification of the results by several scale model experiments are summarized. (orig./HP)

A Cross-Validation Study of Police Recruit Performance as Predicted by the IPI and MMPI.

Science.gov (United States)

Shusman, Elizabeth J.; And Others

Validation and cross-validation studies were conducted using the Minnesota Multiphasic Personality Inventory (MMPI) and Inwald Personality Inventory (IPI) to predict job performance for 698 urban male police officers who completed a six-month training academy. Job performance criteria evaluated included absence, lateness, derelictions, negative…

Plutonium storage criteria

Energy Technology Data Exchange (ETDEWEB)

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.

New true-triaxial rock strength criteria considering intrinsic material characteristics

Science.gov (United States)

Zhang, Qiang; Li, Cheng; Quan, Xiaowei; Wang, Yanning; Yu, Liyuan; Jiang, Binsong

2018-02-01

A reasonable strength criterion should reflect the hydrostatic pressure effect, minimum principal stress effect, and intermediate principal stress effect. The former two effects can be described by the meridian curves, and the last one mainly depends on the Lode angle dependence function. Among three conventional strength criteria, i.e. Mohr-Coulomb (MC), Hoek-Brown (HB), and Exponent (EP) criteria, the difference between generalized compression and extension strength of EP criterion experience a firstly increase then decrease process, and tends to be zero when hydrostatic pressure is big enough. This is in accordance with intrinsic rock strength characterization. Moreover, the critical hydrostatic pressure I_c corresponding to the maximum difference of between generalized compression and extension strength can be easily adjusted by minimum principal stress influence parameter K. So, the exponent function is a more reasonable meridian curves, which well reflects the hydrostatic pressure effect and is employed to describe the generalized compression and extension strength. Meanwhile, three Lode angle dependence functions of L_{{MN}}, L_{{WW}}, and L_{{YMH}}, which unconditionally satisfy the convexity and differential requirements, are employed to represent the intermediate principal stress effect. Realizing the actual strength surface should be located between the generalized compression and extension surface, new true-triaxial criteria are proposed by combining the two states of EP criterion by Lode angle dependence function with a same lode angle. The proposed new true-triaxial criteria have the same strength parameters as EP criterion. Finally, 14 groups of triaxial test data are employed to validate the proposed criteria. The results show that the three new true-triaxial exponent criteria, especially the Exponent Willam-Warnke criterion (EPWW) criterion, give much lower misfits, which illustrates that the EP criterion and L_{{WW}} have more reasonable meridian

Ultrasound in the evaluation of enthesitis: status and perspectives.

Science.gov (United States)

Gandjbakhch, Frédérique; Terslev, Lene; Joshua, Fredrick; Wakefield, Richard J; Naredo, Esperanza; D'Agostino, Maria Antonietta

2011-01-01

An increasing number of studies have applied ultrasound to the evaluation of entheses in spondyloarthritis patients. However, no clear agreement exists on the definition of enthesitis, on the number and choice of entheses to examine and on ultrasound technique, which may all affect the results of the examination. The objectives of this study were to first determine the level of homogeneity in the ultrasound definitions for the principal lesions of enthesitis in the published literature and second, to evaluate the metric properties of ultrasound for detecting enthesitis according to the OMERACT filter. Search was performed in PUBMED and EMBASE. Both grey-scale and Doppler definitions of enthesitis, including describing features of enthesitis, were collected and metrological qualities of studies were assessed. After selection, 48 articles were analyzed. The definition of ultrasound enthesitis and elementary features varied among authors. Grey-scale enthesitis was characterized by increasing thickness (94% of studies), hypoechogenicity (83%), enthesophytes (69%), erosions (67%), calcifications (52%), associated bursitis (46%) and cortical irregularities (29%). Only 46% of studies reported the use of Doppler. High discrepancies were observed on frequency, type of probe and Doppler mode used. Face and content validity were the most frequently evaluated criteria (43%) followed by reliability (29%) and responsiveness (19%). Ultrasound has evidence to support face, content validity and reliability for the evaluation of enthesitis, though there is a lack of well-reported methodology in most of the studies. Consensus on elementary lesions and standardization of exam is needed to determine the ultrasound definition of enthesitis in grey-scale and in Doppler for future applications.

Interpretation criteria for FDG PET/CT in multiple myeloma (IMPeTUs): final results. IMPeTUs (Italian myeloma criteria for PET USe).

Science.gov (United States)

Nanni, Cristina; Versari, Annibale; Chauvie, Stephane; Bertone, Elisa; Bianchi, Andrea; Rensi, Marco; Bellò, Marilena; Gallamini, Andrea; Patriarca, Francesca; Gay, Francesca; Gamberi, Barbara; Ghedini, Pietro; Cavo, Michele; Fanti, Stefano; Zamagni, Elena

2018-05-01

overall for all the scans together. DS proved highly reproducible with the highest reproducibility for score 4. IMPeTUs criteria proved highly reproducible and could therefore be considered as a base for harmonizing PET interpretation in multiple myeloma. A prospective clinical validation of IMPeTUs criteria is underway.

[Cognition-correlation indices of gender schema: tests of validity].

Science.gov (United States)

Ishida, E

1994-02-01

Four-hundred and seventy-seven subjects evaluated a set of traits and behaviors in terms of how masculine and feminine they were and in terms of how well they represented their real and ideal self-images. Within-individual correlation coefficients between these evaluations were proposed as measures of psychological gender schemata, because they would represent the degree of matching between the subjects' gender-image and ideal/real self-images of gender-related attributes. The present study aims at examining the construct validity of these measures, by testing them to psychological variables that are known to reflect gender identity. The individual difference variables used as criteria were (a) satisfaction with one's own sex, (b) general happiness, (c) self-esteem (d) gender-conflict, and (e) school and occupational achievement need. Correlations between the gender-schema indices and the criteria variables supported the construct validity of those measures. Advantages of the present measurement over the conventional simple trait approach, such as BSRI, or PAQ are discussed.

Validation of a tool for assessing the quality of pharmaceutical services

Directory of Open Access Journals (Sweden)

Cosendey Marly Aparecida E.

2003-01-01

Full Text Available This paper presents the validation process for a tool assessing basic pharmaceutical services through an analysis of the implementation of a Basic Pharmaceuticals Distribution Program by the Brazilian Federal government. The process began with the drafting of a theoretical model, based on a state-of-the-art review and allowing the selection of various conceptual dimensions and respective criteria that best represented the construct. The second step involved weighting indicators for the construction of quality scores. Three models were tested for ranking implementation levels, and seven simulations were conducted, determining the score most closely reflecting the selected indicators in two different matrices. The objective was to select the most coherent and consistent version between implementation levels and expected outcomes, while simultaneously enhancing validity of chosen criteria. Testing of the various models and the results obtained showed that augmenting the validity of the study was possible without altering data. This endeavor is justified in understanding the scope and limitations of these measurements and of the choices involved in issues concerning their weighting and interpretation.

Groundwater Model Validation

Energy Technology Data Exchange (ETDEWEB)

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

Squale: evaluation criteria of functioning safety; Squale: criteres d`evaluation de la surete de fonctionnement

Energy Technology Data Exchange (ETDEWEB)

Deswarte, Y; Kaaniche, M [Centre National de la Recherche Scientifique (CNRS), 31 - Toulouse (France). Laboratoire d` Analyse et d` Architecture des Systemes; Corneillie, P [CE2A-DI, 92 - Courbevoie (France); Benoit, P [Matra Transport International, 92 - Montrouge (France)

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.) 15 refs.

A guideline for the validation of likelihood ratio methods used for forensic evidence evaluation.

Science.gov (United States)

Meuwly, Didier; Ramos, Daniel; Haraksim, Rudolf

2017-07-01

This Guideline proposes a protocol for the validation of forensic evaluation methods at the source level, using the Likelihood Ratio framework as defined within the Bayes' inference model. In the context of the inference of identity of source, the Likelihood Ratio is used to evaluate the strength of the evidence for a trace specimen, e.g. a fingermark, and a reference specimen, e.g. a fingerprint, to originate from common or different sources. Some theoretical aspects of probabilities necessary for this Guideline were discussed prior to its elaboration, which started after a workshop of forensic researchers and practitioners involved in this topic. In the workshop, the following questions were addressed: "which aspects of a forensic evaluation scenario need to be validated?", "what is the role of the LR as part of a decision process?" and "how to deal with uncertainty in the LR calculation?". The questions: "what to validate?" focuses on the validation methods and criteria and "how to validate?" deals with the implementation of the validation protocol. Answers to these questions were deemed necessary with several objectives. First, concepts typical for validation standards [1], such as performance characteristics, performance metrics and validation criteria, will be adapted or applied by analogy to the LR framework. Second, a validation strategy will be defined. Third, validation methods will be described. Finally, a validation protocol and an example of validation report will be proposed, which can be applied to the forensic fields developing and validating LR methods for the evaluation of the strength of evidence at source level under the following propositions. Copyright © 2016. Published by Elsevier B.V.

The Discriminative validity of "nociceptive," "peripheral neuropathic," and "central sensitization" as mechanisms-based classifications of musculoskeletal pain.

LENUS (Irish Health Repository)

Smart, Keith M

2012-02-01

OBJECTIVES: Empirical evidence of discriminative validity is required to justify the use of mechanisms-based classifications of musculoskeletal pain in clinical practice. The purpose of this study was to evaluate the discriminative validity of mechanisms-based classifications of pain by identifying discriminatory clusters of clinical criteria predictive of "nociceptive," "peripheral neuropathic," and "central sensitization" pain in patients with low back (+\\/- leg) pain disorders. METHODS: This study was a cross-sectional, between-patients design using the extreme-groups method. Four hundred sixty-four patients with low back (+\\/- leg) pain were assessed using a standardized assessment protocol. After each assessment, patients\\' pain was assigned a mechanisms-based classification. Clinicians then completed a clinical criteria checklist indicating the presence\\/absence of various clinical criteria. RESULTS: Multivariate analyses using binary logistic regression with Bayesian model averaging identified a discriminative cluster of 7, 3, and 4 symptoms and signs predictive of a dominance of "nociceptive," "peripheral neuropathic," and "central sensitization" pain, respectively. Each cluster was found to have high levels of classification accuracy (sensitivity, specificity, positive\\/negative predictive values, positive\\/negative likelihood ratios). DISCUSSION: By identifying a discriminatory cluster of symptoms and signs predictive of "nociceptive," "peripheral neuropathic," and "central" pain, this study provides some preliminary discriminative validity evidence for mechanisms-based classifications of musculoskeletal pain. Classification system validation requires the accumulation of validity evidence before their use in clinical practice can be recommended. Further studies are required to evaluate the construct and criterion validity of mechanisms-based classifications of musculoskeletal pain.

Expanding the Taxonomy of the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD)

Science.gov (United States)

Peck, Christopher C.; Goulet, Jean-Paul; Lobbezoo, Frank; Schiffman, Eric L.; Alstergren, Per; Anderson, Gary C.; de Leeuw, Reny; Jensen, Rigmor; Michelotti, Ambra; Ohrbach, Richard; Petersson, Arne; List, Thomas

2014-01-01

Background There is a need to expand the current temporomandibular disorder (TMD) 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. Methods 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 operationalize and study the criteria. The disorders were derived from the literature when possible and based on expert opinion as necessary. The expanded TMD taxonomy was presented for feedback at international meetings. Results 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 operationalized diagnostic criteria, not clearly related to TMDs, or not sufficiently distinct from disorders already included within the taxonomy. Conclusions The expanded TMD taxonomy offers an integrated approach to clinical diagnosis and provides a framework for further research to operationalize and test the proposed taxonomy and diagnostic criteria. PMID:24443898

Markers for nutrition studies: review of criteria for the evaluation of markers.

Science.gov (United States)

de Vries, Jan; Antoine, Jean-Michel; Burzykowski, Tomasz; Chiodini, Alessandro; Gibney, Mike; Kuhnle, Gunter; Méheust, Agnès; Pijls, Loek; Rowland, Ian

2013-10-01

Markers are important tools to assess the nutrition status and effects of nutrition interventions. There is currently insufficient consensus in nutrition sciences on how to evaluate markers, despite the need for properly evaluating them. To identify the criteria for the evaluation of markers related to nutrition, health and disease and to propose generic criteria for evaluation. The report on "Evaluation of Biomarker and Surrogate Endpoints in Chronic Disease" from the Institute of Medicine was the starting point for the literature search. Additionally, specific search strategies were developed for Pubmed. In nutrition, no set of criteria or systematic approach to evaluate markers is currently available. There is a reliance on the medical area where statistical methods have been developed to quantify the evaluation of markers. Even here, a systematic approach is lacking-markers are still evaluated on a case-by-case basis. The review of publications from the literature search resulted in a database with definitions, criteria for validity and the rationale behind the criteria. It was recognized that, in nutrition, a number of methodological aspects differ from medical research. The following criteria were identified as essential elements in the evaluation of markers: (1) the marker has a causal biological link with the endpoint, (2) there is a significant association between marker and endpoint in the target population, (3) marker changes consistently with the endpoint, e.g., in response to an intervention, and (4) change in the marker explains a substantial proportion of the change in the endpoint in response to the intervention.

Assessment of bachelor's theses in a nursing degree with a rubrics system: Development and validation study.

Science.gov (United States)

González-Chordá, Víctor M; Mena-Tudela, Desirée; Salas-Medina, Pablo; Cervera-Gasch, Agueda; Orts-Cortés, Isabel; Maciá-Soler, Loreto

2016-02-01

Writing a bachelor thesis (BT) is the last step to obtain a nursing degree. In order to perform an effective assessment of a nursing BT, certain reliable and valid tools are required. To develop and validate a 3-rubric system (drafting process, dissertation, and viva) to assess final year nursing students' BT. A multi-disciplinary study of content validity and psychometric properties. The study was carried out between December 2014 and July 2015. Nursing Degree at Universitat Jaume I. Spain. Eleven experts (9 nursing professors and 2 education professors from 6 different universities) took part in the development and content validity stages. Fifty-two theses presented during the 2014-2015 academic year were included by consecutive sampling of cases in order to study the psychometric properties. First, a group of experts was created to validate the content of the assessment system based on three rubrics (drafting process, dissertation, and viva). Subsequently, a reliability and validity study of the rubrics was carried out on the 52 theses presented during the 2014-2015 academic year. The BT drafting process rubric has 8 criteria (S-CVI=0.93; α=0.837; ICC=0.614), the dissertation rubric has 7 criteria (S-CVI=0.9; α=0.893; ICC=0.74), and the viva rubric has 4 criteria (S-CVI=0.86; α=8.16; ICC=0.895). A nursing BT assessment system based on three rubrics (drafting process, dissertation, and viva) has been validated. This system may be transferred to other nursing degrees or degrees from other academic areas. It is necessary to continue with the validation process taking into account factors that may affect the results obtained. Copyright © 2015 Elsevier Ltd. All rights reserved.

Clinical reliability and validity of elbow functional assessment in rheumatoid arthritis.

NARCIS (Netherlands)

Boer, Y.A. de; Ende, C.H.M. van den; Eygendaal, D.; Jolie, I.M.M.; Hazes, J.M.W.; Rozing, P.M.

1999-01-01

OBJECTIVES: (1) To investigate the measurement characteristics of the Hospital for Special Surgery (HSS) and Mayo Clinic elbow assessment instruments, utilizing methodological criteria including feasibility, reliability, validity, and discriminative ability; and (2) to develop an efficient and

Are Classification Criteria for IgG4-RD Now Possible? The Concept of IgG4-Related Disease and Proposal of Comprehensive Diagnostic Criteria in Japan

Directory of Open Access Journals (Sweden)

Kazuichi Okazaki

2012-01-01

Full Text Available Recent studies suggest simultaneous or metachronous lesions in multiorgans characterized by elevated serum levels of IgG4 and abundant infiltration of IgG4-positive plasma cells with various degrees of fibrosis. Two Japanese research committees for IgG4-RD, one from fibrosclerosis (Okazaki team and the other from lymph proliferation (Umehara team supported by the “Research Program for Intractable Disease” of the Ministry of Health, Labor, and Welfare of Japan, have agreed with the unified nomenclature as “IgG4-RD” and proposed the comprehensive diagnostic criteria (CDC for IgG4-RD. Validation of the CDC demonstrated satisfactory sensitivity for the practical use of general physicians and nonspecialists but low sensitivity in the organs to be difficult in taking biopsy specimens such as type1 autoimmune pancreatitis (IgG4-related AIP, compared with IgG4-related sialadenitis/dacryoadenitis (Mikulicz's disease and IgG4-related kidney disease. Although the diagnostic criteria covering all IgG4-RD are hard to be established, combination with the CDC and organ-specific diagnostic criteria should improve sensitivity.

Characteristics and Psychiatric Symptoms of Internet Gaming Disorder among Adults Using Self-Reported DSM-5 Criteria

Science.gov (United States)

Kim, Na Ri; Hwang, Samuel Suk-Hyun; Choi, Jung-Seok; Kim, Dai-Jin; Demetrovics, Zsolt; Király, Orsolya; Nagygyörgy, Katalin; Griffiths, Mark. D.; Hyun, So Yeon; Youn, Hyun Chul

2016-01-01

Objective The Section III of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) proposed nine diagnostic criteria and five cut-point criteria for Internet Gaming Disorder (IGD). We aimed to examine the efficacy of such criteria. Methods Adults (n=3041, men: 1824, women: 1217) who engaged in internet gaming within last 6 months completed a self-report online survey using the suggested wordings of the criteria in DSM-5. Major characteristics, gaming behavior, and psychiatric symptoms of IGD were analyzed using ANOVA, chi-square, and correlation analyses. Results The sociodemographic variables were not statistically significant between the healthy controls and the risk group. Among the participants, 419 (13.8%) were identified and labeled as the IGD risk group. The IGD risk group scored significantly higher on all motivation subscales (psymptom dimensions, i.e., somatization, obsession-compulsion, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism (p<0.001). Conclusion The IGD risk group showed differential psychopathological manifestations according to DSM-5 IGD diagnostic criteria. Further studies are needed to evaluate the reliability and validity of the specific criteria, especially for developing screening instruments. PMID:26766947

[Reliability and validity of the Braden Scale for predicting pressure sore risk].

Science.gov (United States)

Boes, C

2000-12-01

For more accurate and objective pressure sore risk assessment various risk assessment tools were developed mainly in the USA and Great Britain. The Braden Scale for Predicting Pressure Sore Risk is one such example. By means of a literature analysis of German and English texts referring to the Braden Scale the scientific control criteria reliability and validity will be traced and consequences for application of the scale in Germany will be demonstrated. Analysis of 4 reliability studies shows an exclusive focus on interrater reliability. Further, even though examination of 19 validity studies occurs in many different settings, such examination is limited to the criteria sensitivity and specificity (accuracy). The range of sensitivity and specificity level is 35-100%. The recommended cut off points rank in the field of 10 to 19 points. The studies prove to be not comparable with each other. Furthermore, distortions in these studies can be found which affect accuracy of the scale. The results of the here presented analysis show an insufficient proof for reliability and validity in the American studies. In Germany, the Braden scale has not yet been tested under scientific criteria. Such testing is needed before using the scale in different German settings. During the course of such testing, construction and study procedures of the American studies can be used as a basis as can the problems be identified in the analysis presented below.

AAPT Diagnostic Criteria for Chronic Cancer Pain Conditions.

Science.gov (United States)

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

Repository operational criteria analysis

International Nuclear Information System (INIS)

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

A Systematic Review on the Validity of Teledentistry.

Science.gov (United States)

Alabdullah, Jafar H; Daniel, Susan J

2018-01-05

The aim of this systematic review was to evaluate the validity of using teledentistry in oral care examination and diagnosis. In June 2016, a systematic search of the literature was conducted without time restrictions in three electronic databases (Ebscohost, Pubmed, and Scopus). Two reviewers screened the retrieved articles first by title and then by abstract to determine relevant articles for full text review. Studies included were as follows: (1) related to teledentistry, (2) available in full text and English, (3) compared teledentistry application to a gold standard, and (4) provided clear statistical tests for validity. The methodological quality of studies was determined using the "Quality Assessment of Studies of Diagnostic Accuracy (QUADAS)." Seventy-nine studies met the initial search criteria. Following removal of duplicate articles, only 58 were remaining and reviewed by title and abstract, yielding 14 full-text articles. Nine of the full-text articles met the inclusion criteria. Results of the QUADAS assessment varied from 9 to 13 out of 14 items; therefore, studies demonstrated high quality (>60%). Validity of teledentistry varied and is reported by range for the following statistics: sensitivity (n = 8, 25-100%), specificity (n = 7, 68-100%), positive predictive value (n = 5, 57-100%), and negative predictive value (n = 5, 50-100%). Kappa statistics were also reported for evaluation of reliability between gold standard and teledentistry examination (n = 6, 46-93%). Teledentistry could be comparable to face-to-face for oral screening, especially in school-based programs, rural areas and areas with limited access to care, and long-term care facilities. Identification of oral diseases, referrals, and teleconsultations are possible and valid. The need for methodologically designed studies with appropriate statistical tests to determine the validity of teledentistry exists.

Toward a Process-Focused Model of Test Score Validity: Improving Psychological Assessment in Science and Practice

Science.gov (United States)

Bornstein, Robert F.

2011-01-01

Although definitions of validity have evolved considerably since L. J. Cronbach and P. E. Meehl's classic (1955) review, contemporary validity research continues to emphasize correlational analyses assessing predictor-criterion relationships, with most outcome criteria being self-reports. The present article describes an alternative way of…

A GIS-based extended fuzzy multi-criteria evaluation for landslide susceptibility mapping

Science.gov (United States)

Feizizadeh, Bakhtiar; Shadman Roodposhti, Majid; Jankowski, Piotr; Blaschke, Thomas

2014-01-01

Landslide susceptibility mapping (LSM) is making increasing use of GIS-based spatial analysis in combination with multi-criteria evaluation (MCE) methods. We have developed a new multi-criteria decision analysis (MCDA) method for LSM and applied it to the Izeh River basin in south-western Iran. Our method is based on fuzzy membership functions (FMFs) derived from GIS analysis. It makes use of nine causal landslide factors identified by local landslide experts. Fuzzy set theory was first integrated with an analytical hierarchy process (AHP) in order to use pairwise comparisons to compare LSM criteria for ranking purposes. FMFs were then applied in order to determine the criteria weights to be used in the development of a landslide susceptibility map. Finally, a landslide inventory database was used to validate the LSM map by comparing it with known landslides within the study area. Results indicated that the integration of fuzzy set theory with AHP produced significantly improved accuracies and a high level of reliability in the resulting landslide susceptibility map. Approximately 53% of known landslides within our study area fell within zones classified as having “very high susceptibility”, with the further 31% falling into zones classified as having “high susceptibility”. PMID:26089577

Assessing health status and quality-of-life instruments: attributes and review criteria.

Science.gov (United States)

Aaronson, Neil; Alonso, Jordi; Burnam, Audrey; Lohr, Kathleen N; Patrick, Donald L; Perrin, Edward; Stein, Ruth E

2002-05-01

The field of health status and quality of life (QoL) measurement - as a formal discipline with a cohesive theoretical framework, accepted methods, and diverse applications--has been evolving for the better part of 30 years. To identify health status and QoL instruments and review them against rigorous criteria as a precursor to creating an instrument library for later dissemination, the Medical Outcomes Trust in 1994 created an independently functioning Scientific Advisory Committee (SAC). In the mid-1990s, the SAC defined a set of attributes and criteria to carry out instrument assessments; 5 years later, it updated and revised these materials to take account of the expanding theories and technologies upon which such instruments were being developed. This paper offers the SAC's current conceptualization of eight key attributes of health status and QoL instruments (i.e., conceptual and measurement model; reliability; validity; responsiveness; interpretability; respondent and administrative burden; alternate forms; and cultural and language adaptations) and the criteria by which instruments would be reviewed on each of those attributes. These are suggested guidelines for the field to consider and debate; as measurement techniques become both more familiar and more sophisticated, we expect that experts will wish to update and refine these criteria accordingly.

The Validation of NAA Method Used as Test Method in Serpong NAA Laboratory

International Nuclear Information System (INIS)

Rina-Mulyaningsih, Th.

2004-01-01

The Validation Of NAA Method Used As Test Method In Serpong NAA Laboratory. NAA Method is a non standard testing method. The testing laboratory shall validate its using method to ensure and confirm that it is suitable with application. The validation of NAA methods have been done with the parameters of accuracy, precision, repeatability and selectivity. The NIST 1573a Tomato Leaves, NIES 10C Rice flour unpolished and standard elements were used in this testing program. The result of testing with NIST 1573a showed that the elements of Na, Zn, Al and Mn are met from acceptance criteria of accuracy and precision, whereas Co is rejected. The result of testing with NIES 10C showed that Na and Zn elements are met from acceptance criteria of accuracy and precision, but Mn element is rejected. The result of selectivity test showed that the value of quantity is between 0.1-2.5 μg, depend on the elements. (author)

Pragmatic criteria of the definition of neonatal near miss: a comparative study.

Science.gov (United States)

Kale, Pauline Lorena; Jorge, Maria Helena Prado de Mello; Laurenti, Ruy; Fonseca, Sandra Costa; Silva, Kátia Silveira da

2017-12-04

The objective of this study was to test the validity of the pragmatic criteria of the definitions of neonatal near miss, extending them throughout the infant period, and to estimate the indicators of perinatal care in public maternity hospitals. A cohort of live births from six maternity hospitals in the municipalities of São Paulo, Niterói, and Rio de Janeiro, Brazil, was carried out in 2011. We carried out interviews and checked prenatal cards and medical records. We compared the pragmatic criteria (birth weight, gestational age, and 5' Apgar score) of the definitions of near miss of Pileggi et al., Pileggi-Castro et al., Souza et al., and Silva et al. We calculated sensitivity, specificity (gold standard: infant mortality), percentage of deaths among newborns with life-threatening conditions, and rates of near miss, mortality, and severe outcomes per 1,000 live births. A total 7,315 newborns were analyzed (completeness of information > 99%). The sensitivity of the definition of Pileggi-Castro et al. was higher, resulting in a higher number of cases of near miss, Souza et al. presented lower value, and Pileggi et al. and de Silva et al. presented intermediate values. There is an increase in sensitivity when the period goes from 0-6 to 0-27 days, and there is a decrease when it goes to 0-364 days. Specificities were high (≥ 97%) and above sensitivities (54% to 77%). One maternity hospital in São Paulo and one in Niterói presented, respectively, the lowest and highest rates of infant mortality, near miss, and frequency of births with life-threatening conditions, regardless of the definition. The definitions of near miss based exclusively on pragmatic criteria are valid and can be used for monitoring purposes. Based on the perinatal literature, the cutoff points adopted by Silva et al. were more appropriate. Periodic studies could apply a more complete definition, incorporating clinical, laboratory, and management criteria, including congenital anomalies

CFD Validation Experiment of a Mach 2.5 Axisymmetric Shock-Wave/Boundary-Layer Interaction

Science.gov (United States)

Davis, David O.

2015-01-01

Experimental investigations of specific flow phenomena, e.g., Shock Wave Boundary-Layer Interactions (SWBLI), provide great insight to the flow behavior but often lack the necessary details to be useful as CFD validation experiments. Reasons include: 1.Undefined boundary conditions Inconsistent results 2.Undocumented 3D effects (CL only measurements) 3.Lack of uncertainty analysis While there are a number of good subsonic experimental investigations that are sufficiently documented to be considered test cases for CFD and turbulence model validation, the number of supersonic and hypersonic cases is much less. This was highlighted by Settles and Dodsons [1] comprehensive review of available supersonic and hypersonic experimental studies. In all, several hundred studies were considered for their database.Of these, over a hundred were subjected to rigorous acceptance criteria. Based on their criteria, only 19 (12 supersonic, 7 hypersonic) were considered of sufficient quality to be used for validation purposes. Aeschliman and Oberkampf [2] recognized the need to develop a specific methodology for experimental studies intended specifically for validation purposes.

Development and validation of a game addiction scale for adolescents

NARCIS (Netherlands)

Lemmens, J.S.; Valkenburg, P.M.; Peter, J.

2009-01-01

The aim of this study was to develop and validate a scale to measure computer and videogame addiction. Inspired by earlier theories and research on game addiction, we created 21 items to measure seven underlying criteria (i.e., salience, tolerance, mood modification, relapse, withdrawal, conflict,

Entropy Evaluation Based on Value Validity

Directory of Open Access Journals (Sweden)

Tarald O. Kvålseth

2014-09-01

Full Text Available Besides its importance in statistical physics and information theory, the Boltzmann-Shannon entropy S has become one of the most widely used and misused summary measures of various attributes (characteristics in diverse fields of study. It has also been the subject of extensive and perhaps excessive generalizations. This paper introduces the concept and criteria for value validity as a means of determining if an entropy takes on values that reasonably reflect the attribute being measured and that permit different types of comparisons to be made for different probability distributions. While neither S nor its relative entropy equivalent S* meet the value-validity conditions, certain power functions of S and S* do to a considerable extent. No parametric generalization offers any advantage over S in this regard. A measure based on Euclidean distances between probability distributions is introduced as a potential entropy that does comply fully with the value-validity requirements and its statistical inference procedure is discussed.

Approximating a DSM-5 Diagnosis of PTSD Using DSM-IV Criteria

Science.gov (United States)

Rosellini, Anthony J.; Stein, Murray B.; Colpe, Lisa J.; Heeringa, Steven G.; Petukhova, Maria V.; Sampson, Nancy A.; Schoenbaum, Michael; Ursano, Robert J.; Kessler, Ronald C.

2015-01-01

Background Diagnostic criteria for DSM-5 posttraumatic stress disorder (PTSD) are in many ways similar to DSM-IV criteria, raising the possibility that it might be possible to closely approximate DSM-5 diagnoses using DSM-IV symptoms. If so, the resulting transformation rules could be used to pool research data based on the two criteria sets. Methods The Pre-Post Deployment Study (PPDS) of the Army Study to Assess Risk and Resilience in Servicemembers (Army STARRS) administered a blended 30-day DSM-IV and DSM-5 PTSD symptom assessment based on the civilian PTSD Checklist for DSM-IV (PCL-C) and the PTSD Checklist for DSM-5 (PCL-5). This assessment was completed by 9,193 soldiers from three US Army Brigade Combat Teams approximately three months after returning from Afghanistan. PCL-C items were used to operationalize conservative and broad approximations of DSM-5 PTSD diagnoses. The operating characteristics of these approximations were examined compared to diagnoses based on actual DSM-5 criteria. Results The estimated 30-day prevalence of DSM-5 PTSD based on conservative (4.3%) and broad (4.7%) approximations of DSM-5 criteria using DSM-IV symptom assessments were similar to estimates based on actual DSM-5 criteria (4.6%). Both approximations had excellent sensitivity (92.6-95.5%), specificity (99.6-99.9%), total classification accuracy (99.4-99.6%), and area under the receiver operating characteristic curve (0.96-0.98). Conclusions DSM-IV symptoms can be used to approximate DSM-5 diagnoses of PTSD among recently-deployed soldiers, making it possible to recode symptom-level data from earlier DSM-IV studies to draw inferences about DSM-5 PTSD. However, replication is needed in broader trauma-exposed samples to evaluate the external validity of this finding. PMID:25845710

Prognosis and cost-effectiveness of IVF in poor responders according to the Bologna Criteria.

Science.gov (United States)

Busnelli, Andrea; Somigliana, Edgardo

2018-02-01

Poor ovarian response (POR) to controlled ovarian hyperstimulation for in vitro fertilization (IVF) is one of the most challenging issue in the field of reproductive medicine. However, even if improving IVF outcome in poor responders (PORs) represents a main priority, the lack of a unique definition of POR has hampered research in this area. In order to overcome this impediment, an ESHRE Campus Workshop was organized in Bologna in 2010 and reached a consensus on the criteria for the diagnosis of POR ("Bologna Criteria"). In this review we aimed to estimate the prognostic potential of the ESHRE definition, to elucidate its possible weaknesses and to analyze the economic aspects of IVF in a population of poor responders (PORs). Available evidence confirmed that the Bologna criteria are able to select a population with a poor IVF prognosis thus supporting their validity. Nonetheless, different aspects of the definition have been criticized. The main points of debate concern the homogeneity of the population identified, the cut-off values chosen for the ovarian reserve tests and the risks factors other than age associated with POR. Data concerning the economic profile of IVF in PORs are scanty. The only published study on the argument showed that IVF in these cases is not cost-effective. However, considering the potential substantial impact of cost-effectiveness analyses on public health policies, there is the need for further and independent validations.

Comparison of different multi-objective calibration criteria using a conceptual rainfall-runoff model of flood events

Directory of Open Access Journals (Sweden)

R. Moussa

2009-04-01

Full Text Available A conceptual lumped rainfall-runoff flood event model was developed and applied on the Gardon catchment located in Southern France and various single-objective and multi-objective functions were used for its calibration. The model was calibrated on 15 events and validated on 14 others. The results of both the calibration and validation phases are compared on the basis of their performance with regards to six criteria, three global criteria and three relative criteria representing volume, peakflow, and the root mean square error. The first type of criteria gives more weight to large events whereas the second considers all events to be of equal weight. The results show that the calibrated parameter values are dependent on the type of criteria used. Significant trade-offs are observed between the different objectives: no unique set of parameters is able to satisfy all objectives simultaneously. Instead, the solution to the calibration problem is given by a set of Pareto optimal solutions. From this set of optimal solutions, a balanced aggregated objective function is proposed, as a compromise between up to three objective functions. The single-objective and multi-objective calibration strategies are compared both in terms of parameter variation bounds and simulation quality. The results of this study indicate that two well chosen and non-redundant objective functions are sufficient to calibrate the model and that the use of three objective functions does not necessarily yield different results. The problems of non-uniqueness in model calibration, and the choice of the adequate objective functions for flood event models, emphasise the importance of the modeller's intervention. The recent advances in automatic optimisation techniques do not minimise the user's responsibility, who has to choose multiple criteria based on the aims of the study, his appreciation on the errors induced by data and model structure and his knowledge of the

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

Science.gov (United States)

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.

The concept of borderline conditions: a critical comment on validity issues

DEFF Research Database (Denmark)

Parnas, Josef

1994-01-01

is dominated by an exaggerated quest for reliability at the expense of concern with validity issues. Concepts of operational criteria, polythetic-prototypic systems, and epistemic peculiarities of psychiatric, clinical typification are briefly exposed. It is suggested that future scientific progress...

Validation of asthma recording in electronic health records: a systematic review

Directory of Open Access Journals (Sweden)

Nissen F

2017-12-01

Full Text Available Francis Nissen,1 Jennifer K Quint,2 Samantha Wilkinson,1 Hana Mullerova,3 Liam Smeeth,1 Ian J Douglas1 1Department of Non-Communicable Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK; 2National Heart and Lung Institute, Imperial College, London, UK; 3RWD & Epidemiology, GSK R&D, Uxbridge, UK Objective: To describe the methods used to validate asthma diagnoses in electronic health records and summarize the results of the validation studies. Background: Electronic health records are increasingly being used for research on asthma to inform health services and health policy. Validation of the recording of asthma diagnoses in electronic health records is essential to use these databases for credible epidemiological asthma research.Methods: We searched EMBASE and MEDLINE databases for studies that validated asthma diagnoses detected in electronic health records up to October 2016. Two reviewers independently assessed the full text against the predetermined inclusion criteria. Key data including author, year, data source, case definitions, reference standard, and validation statistics (including sensitivity, specificity, positive predictive value [PPV], and negative predictive value [NPV] were summarized in two tables.Results: Thirteen studies met the inclusion criteria. Most studies demonstrated a high validity using at least one case definition (PPV >80%. Ten studies used a manual validation as the reference standard; each had at least one case definition with a PPV of at least 63%, up to 100%. We also found two studies using a second independent database to validate asthma diagnoses. The PPVs of the best performing case definitions ranged from 46% to 58%. We found one study which used a questionnaire as the reference standard to validate a database case definition; the PPV of the case definition algorithm in this study was 89%. Conclusion: Attaining high PPVs (>80% is possible using each of the discussed validation

A multidimensional assessment of the validity and utility of alcohol use disorder severity as determined by item response theory models.

Science.gov (United States)

Dawson, Deborah A; Saha, Tulshi D; Grant, Bridget F

2010-02-01

The relative severity of the 11 DSM-IV alcohol use disorder (AUD) criteria are represented by their severity threshold scores, an item response theory (IRT) model parameter inversely proportional to their prevalence. These scores can be used to create a continuous severity measure comprising the total number of criteria endorsed, each weighted by its relative severity. This paper assesses the validity of the severity ranking of the 11 criteria and the overall severity score with respect to known AUD correlates, including alcohol consumption, psychological functioning, family history, antisociality, and early initiation of drinking, in a representative population sample of U.S. past-year drinkers (n=26,946). The unadjusted mean values for all validating measures increased steadily with the severity threshold score, except that legal problems, the criterion with the highest score, was associated with lower values than expected. After adjusting for the total number of criteria endorsed, this direct relationship was no longer evident. The overall severity score was no more highly correlated with the validating measures than a simple count of criteria endorsed, nor did the two measures yield different risk curves. This reflects both within-criterion variation in severity and the fact that the number of criteria endorsed and their severity are so highly correlated that severity is essentially redundant. Attempts to formulate a scalar measure of AUD will do as well by relying on simple counts of criteria or symptom items as by using scales weighted by IRT measures of severity. Published by Elsevier Ireland Ltd.

Development of diagnostic criteria for serious non-AIDS events in HIV clinical trials

DEFF Research Database (Denmark)

Lifson, Alan R; Belloso, Waldo H; Davey, Richard T

2010-01-01

PURPOSE: Serious non-AIDS (SNA) diseases are important causes of morbidity and mortality in the HAART era. We describe development of standard criteria for 12 SNA events for Endpoint Review Committee (ERC) use in START, a multicenter international HIV clinical trial. METHODS: SNA definitions were...... was reached. CONCLUSION: HIV clinical trials that include SNA diseases as clinical outcomes should have standardized SNA definitions to optimize event reporting and validation and should have review by an experienced ERC with opportunities for adjudication......., peripheral arterial disease, pulmonary embolism, and stroke. Of 563 potential SNA events reported in ESPRIT and reviewed by an ERC, 72% met "confirmed" and 13% "probable" criteria. Twenty-eight percent of cases initially reviewed by the ERC required follow-up discussion (adjudication) before a final decision...

A comparison of measurements and calculations for the Stripa validation drift inflow experiment

International Nuclear Information System (INIS)

Hodgkinson, D.P.; Cooper, N.S.

1992-01-01

This data presents a comparison of measurements and predictions for groundwater flow to the validation drift and remaining portions of the D-holes in the Site Characterisation and Validation (SCV) block. The comparison was carried out of behalf of the Stripa task force on fracture flow modelling. The paper summarises the characterisation data and their preliminary interpretation, and reviews the fracture flow modelling approaches and predictions made by teams from AEA Technology/Fracflow, Golder Associated and Lawrence Berkely Laboratory. The predictions are compared with the inflow measurements on the basis of the validation process and criteria defined by the Task Force. The results of all three modelling groups meet the validation criteria, with the predictions of the inflow being of the same order of magnitude as the observations. Also the AEA/Fracflow and Golder approaches allow the inflow pattern to be predicted and this too is reproduced with reasonable accuracy. The successful completion of this project demonstrates the feasibility of discrete fracture flow modelling, and in particular the ability to collect and analyse all the necessary characterization data in a timely and economic manner. (32 refs.) (au)

On Conducting Construct Validity Meta-Analyses for the Rorschach: A Reply to Tibon Czopp and Zeligman (2016).

Science.gov (United States)

Mihura, Joni L; Meyer, Gregory J; Dumitrascu, Nicolae; Bombel, George

2016-01-01

We respond to Tibon Czopp and Zeligman's (2016) critique of our systematic reviews and meta-analyses of 65 Rorschach Comprehensive System (CS) variables published in Psychological Bulletin (2013). The authors endorsed our supportive findings but critiqued the same methodology when used for the 13 unsupported variables. Unfortunately, their commentary was based on significant misunderstandings of our meta-analytic method and results, such as thinking we used introspectively assessed criteria in classifying levels of support and reporting only a subset of our externally assessed criteria. We systematically address their arguments that our construct label and criterion variable choices were inaccurate and, therefore, meta-analytic validity for these 13 CS variables was artificially low. For example, the authors created new construct labels for these variables that they called "the customary CS interpretation," but did not describe their methodology nor provide evidence that their labels would result in better validity than ours. They cite studies they believe we should have included; we explain how these studies did not fit our inclusion criteria and that including them would have actually reduced the relevant CS variables' meta-analytic validity. Ultimately, criticisms alone cannot change meta-analytic support from negative to positive; Tibon Czopp and Zeligman would need to conduct their own construct validity meta-analyses.

Admission Criteria for MBA Programs

Directory of Open Access Journals (Sweden)

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.

[Diagnostic validity of attention deficit/hyperactivity disorder: from phenomenology to neurobiology (I)].

Science.gov (United States)

Trujillo-Orrego, N; Pineda, D A; Uribe, L H

2012-03-01

The diagnostic criteria for the attentional deficit hyperactivity disorder (ADHD), were defined by the American Psychiatric Association in the Diagnostic and Statistical Manual of Mental Disorders fourth version (DSM-IV) and World Health Organization in the ICD-10. The American Psychiatric Association used an internal validity analysis to select specific behavioral symptoms associated with the disorder and to build five cross-cultural criteria for its use in the categorical diagnosis. The DSM has been utilized for clinicians and researchers as a valid and stable approach since 1968. We did a systematic review of scientific literature in Spanish and English, aimed to identify the historical origin that supports ADHD as a psychiatric construct. This comprehensive review started exploring the concept of minimal brain dysfunction, hyper-activity, inattention, impulsivity since 1932 to 2011. This paper summarize all the DSM versions that include the definition of ADHD or its equivalent, and it point out the statistical and methodological approach implemented for defining ADHD as a valid epidemiological and psychometric construct. Finally the paper discusses some considerations and suggestions for the new versions of the manual.

The validated sun exposure questionnaire

DEFF Research Database (Denmark)

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...

Change in CD3 positive T-cell expression in psoriatic arthritis synovium correlates with change in DAS28 and magnetic resonance imaging synovitis scores following initiation of biologic therapy--a single centre, open-label study.

LENUS (Irish Health Repository)

Pontifex, Eliza K

2011-01-01

With the development of increasing numbers of potential therapeutic agents in inflammatory disease comes the need for effective biomarkers to help screen for drug efficacy and optimal dosing regimens early in the clinical trial process. This need has been recognized by the Outcome Measures in Rheumatology Clinical Trials (OMERACT) group, which has established guidelines for biomarker validation. To seek a candidate synovial biomarker of treatment response in psoriatic arthritis (PsA), we determined whether changes in immunohistochemical markers of synovial inflammation correlate with changes in disease activity scores assessing 28 joints (ΔDAS28) or magnetic resonance imaging synovitis scores (ΔMRI) in patients with PsA treated with a biologic agent.

76 FR 28664 - Method 301-Field Validation of Pollutant Measurement Methods From Various Waste Media

Science.gov (United States)

2011-05-18

... . d m = The mean of the paired sample differences. n = Total number of paired samples. 7.4.2 t Test... being compared to a validated test method as part of the Method 301 validation and an audit sample for... tighten the acceptance criteria for the precision of candidate alternative test methods. One commenter...

Selection of response criteria for clinical trials of sarcoma treatment.

Science.gov (United States)

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

A Generalized Pivotal Quantity Approach to Analytical Method Validation Based on Total Error.

Science.gov (United States)

Yang, Harry; Zhang, Jianchun

2015-01-01

The primary purpose of method validation is to demonstrate that the method is fit for its intended use. Traditionally, an analytical method is deemed valid if its performance characteristics such as accuracy and precision are shown to meet prespecified acceptance criteria. However, these acceptance criteria are not directly related to the method's intended purpose, which is usually a gurantee that a high percentage of the test results of future samples will be close to their true values. Alternate "fit for purpose" acceptance criteria based on the concept of total error have been increasingly used. Such criteria allow for assessing method validity, taking into account the relationship between accuracy and precision. Although several statistical test methods have been proposed in literature to test the "fit for purpose" hypothesis, the majority of the methods are not designed to protect the risk of accepting unsuitable methods, thus having the potential to cause uncontrolled consumer's risk. In this paper, we propose a test method based on generalized pivotal quantity inference. Through simulation studies, the performance of the method is compared to five existing approaches. The results show that both the new method and the method based on β-content tolerance interval with a confidence level of 90%, hereafter referred to as the β-content (0.9) method, control Type I error and thus consumer's risk, while the other existing methods do not. It is further demonstrated that the generalized pivotal quantity method is less conservative than the β-content (0.9) method when the analytical methods are biased, whereas it is more conservative when the analytical methods are unbiased. Therefore, selection of either the generalized pivotal quantity or β-content (0.9) method for an analytical method validation depends on the accuracy of the analytical method. It is also shown that the generalized pivotal quantity method has better asymptotic properties than all of the current

Criteria CSR

OpenAIRE

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...

First International Public Health Film Competition 2016-reflections on the development and use of competition judging criteria.

Science.gov (United States)

Hoang, U; Luna, P; Russell, P; Bergonzi-King, L; Ashton, J; McCarthy, C; Donovan, H; Inman, P; Seminog, O; Botchway, S

2018-03-01

Film competitions can be a helpful method to understand issues of quality in health films. In this paper, we describe the development and use of explicit quality criteria to identify the 'best' films for the first ever international public health film competition. A film selection committee encompassing a range of stakeholders was compiled. The committee drew up 10 explicit quality criteria to judge films drawing upon other film festival's selection criteria. These criteria were then applied to a broad range of health-related films entered into a film competition to select the 'best' film to screen. Eighty-four films from 20 different countries were submitted to the public health film competition. The originality of the subject covered by the film, the public health importance of the issue and story-telling approach in the film were found to be the most discriminatory criteria to select films. Selection of health films for festivals can be undertaken using explicit quality criteria. There are a number of advantages to such an approach; however, explicit selection involves a large commitment of resources from film festival organizers and there is further research required to test the validity of the quality criteria applied to health-related films.

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

Science.gov (United States)

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.

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'.

Science.gov (United States)

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.

Green Supplier Selection Criteria

DEFF Research Database (Denmark)

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...

The validity of knock-for-knock clauses in comparative perspective

DEFF Research Database (Denmark)

Cavaleri, Sylvie Cécile

This article discusses the validity of so-called knock-for-knock clauses, by which parties to offshore oil and gas or maritime contracts agree that each of them will cover its own losses regardless of who caused them. The issue of validity of such clauses and of the liability exclusions they cont......This article discusses the validity of so-called knock-for-knock clauses, by which parties to offshore oil and gas or maritime contracts agree that each of them will cover its own losses regardless of who caused them. The issue of validity of such clauses and of the liability exclusions...... criteria used to promote or dismiss knock-for-knock clauses in case law and academic literature, the article reaches the conclusion that the question of whether knock-for-knock clauses should be held valid depends on whose interests are being considered, and that further research is warranted...

The design and validation of advanced operator support systems for a role in plant safety

International Nuclear Information System (INIS)

Hughes, G.

1989-06-01

Advanced operator support systems have the potential of making a significant contribution to plant safety. This note reviews the different support functions required, the specification of performance criteria and possible approaches for system validation. The importance of the different functions that can be provided is related to the stage of the accident sequence. Also, because of the restricted reliability of any single system, subdivision of the systems is suggested in order to make the maximum contribution at a number of sequential stages. In this way it should be possible to make a significant claim for reduced operator error over the full accident progression, from incipient fault to disaster. The use of performance criteria currently associated with the classification of safety-grade trip systems (e.g. detection failure probability) would seem to provide a sound basis for validation. The validation of systems is seen as a significant task which will rely on the use of design and training-simulator data together with specific plant measurements. Expert systems appear to present particular problems for validation. (author)

Student mathematical imagination instruments: construction, cultural adaptation and validity

Science.gov (United States)

Dwijayanti, I.; Budayasa, I. K.; Siswono, T. Y. E.

2018-03-01

Imagination has an important role as the center of sensorimotor activity of the students. The purpose of this research is to construct the instrument of students’ mathematical imagination in understanding concept of algebraic expression. The researcher performs validity using questionnaire and test technique and data analysis using descriptive method. Stages performed include: 1) the construction of the embodiment of the imagination; 2) determine the learning style questionnaire; 3) construct instruments; 4) translate to Indonesian as well as adaptation of learning style questionnaire content to student culture; 5) perform content validation. The results stated that the constructed instrument is valid by content validation and empirical validation so that it can be used with revisions. Content validation involves Indonesian linguists, english linguists and mathematics material experts. Empirical validation is done through a legibility test (10 students) and shows that in general the language used can be understood. In addition, a questionnaire test (86 students) was analyzed using a biserial point correlation technique resulting in 16 valid items with a reliability test using KR 20 with medium reability criteria. While the test instrument test (32 students) to find all items are valid and reliability test using KR 21 with reability is 0,62.

External validity of post-stroke interventional gait rehabilitation studies.

Science.gov (United States)

Kafri, Michal; Dickstein, Ruth

2017-01-01

Gait rehabilitation is a major component of stroke rehabilitation, and is supported by extensive research. The objective of this review was to examine the external validity of intervention studies aimed at improving gait in individuals post-stroke. To that end, two aspects of these studies were assessed: subjects' exclusion criteria and the ecological validity of the intervention, as manifested by the intervention's technological complexity and delivery setting. Additionally, we examined whether the target population as inferred from the titles/abstracts is broader than the population actually represented by the reported samples. We systematically researched PubMed for intervention studies to improve gait post-stroke, working backwards from the beginning of 2014. Exclusion criteria, the technological complexity of the intervention (defined as either elaborate or simple), setting, and description of the target population in the titles/abstracts were recorded. Fifty-two studies were reviewed. The samples were exclusive, with recurrent stroke, co-morbidities, cognitive status, walking level, and residency being major reasons for exclusion. In one half of the studies, the intervention was elaborate. Descriptions of participants in the title/abstract in almost one half of the studies included only the diagnosis (stroke or comparable terms) and its stage (acute, subacute, and chronic). The external validity of a substantial number of intervention studies about rehabilitation of gait post-stroke appears to be limited by exclusivity of the samples as well as by deficiencies in ecological validity of the interventions. These limitations are not accurately reflected in the titles or abstracts of the studies.

Validation of the Colorado Retinopathy of Prematurity Screening Model.

Science.gov (United States)

McCourt, Emily A; Ying, Gui-Shuang; Lynch, Anne M; Palestine, Alan G; Wagner, Brandie D; Wymore, Erica; Tomlinson, Lauren A; Binenbaum, Gil

2018-04-01

The Colorado Retinopathy of Prematurity (CO-ROP) model uses birth weight, gestational age, and weight gain at the first month of life (WG-28) to predict risk of severe retinopathy of prematurity (ROP). In previous validation studies, the model performed very well, predicting virtually all cases of severe ROP and potentially reducing the number of infants who need ROP examinations, warranting validation in a larger, more diverse population. To validate the performance of the CO-ROP model in a large multicenter cohort. This study is a secondary analysis of data from the Postnatal Growth and Retinopathy of Prematurity (G-ROP) Study, a retrospective multicenter cohort study conducted in 29 hospitals in the United States and Canada between January 2006 and June 2012 of 6351 premature infants who received ROP examinations. Sensitivity and specificity for severe (early treatment of ROP [ETROP] type 1 or 2) ROP, and reduction in infants receiving examinations. The CO-ROP model was applied to the infants in the G-ROP data set with all 3 data points (infants would have received examinations if they met all 3 criteria: birth weight, large validation cohort. The model requires all 3 criteria to be met to signal a need for examinations, but some infants with a birth weight or gestational age above the thresholds developed severe ROP. Most of these infants who were not detected by the CO-ROP model had obvious deviation in expected weight trajectories or nonphysiologic weight gain. These findings suggest that the CO-ROP model needs to be revised before considering implementation into clinical practice.

Idiopathic environmental intolerance attributed to electromagnetic fields (IEI-EMF: A systematic review of identifying criteria

Directory of Open Access Journals (Sweden)

Baliatsas Christos

2012-08-01

Full Text Available Abstract Background Idiopathic environmental intolerance attributed to electromagnetic fields (IEI-EMF remains a complex and unclear phenomenon, often characterized by the report of various, non-specific physical symptoms (NSPS when an EMF source is present or perceived by the individual. The lack of validated criteria for defining and assessing IEI-EMF affects the quality of the relevant research, hindering not only the comparison or integration of study findings, but also the identification and management of patients by health care providers. The objective of this review was to evaluate and summarize the criteria that previous studies employed to identify IEI-EMF participants. Methods An extensive literature search was performed for studies published up to June 2011. We searched EMBASE, Medline, Psychinfo, Scopus and Web of Science. Additionally, citation analyses were performed for key papers, reference sections of relevant papers were searched, conference proceedings were examined and a literature database held by the Mobile Phones Research Unit of King’s College London was reviewed. Results Sixty-three studies were included. “Hypersensitivity to EMF” was the most frequently used descriptive term. Despite heterogeneity, the criteria predominantly used to identify IEI-EMF individuals were: 1. Self-report of being (hypersensitive to EMF. 2. Attribution of NSPS to at least one EMF source. 3. Absence of medical or psychiatric/psychological disorder capable of accounting for these symptoms 4. Symptoms should occur soon (up to 24 hours after the individual perceives an exposure source or exposed area. (Hypersensitivity to EMF was either generalized (attribution to various EMF sources or source-specific. Experimental studies used a larger number of criteria than those of observational design and performed more frequently a medical examination or interview as prerequisite for inclusion. Conclusions Considerable heterogeneity exists in the

Validation of fibromyalgia survey questionnaire and polysymptomatic distress scale in a Persian population.

Science.gov (United States)

Bidari, Ali; Ghavidel-Parsa, Banafsheh; Amir Maafi, Alireza; Montazeri, Ali; Ghalehbaghi, Babak; Hassankhani, Amir; Aarabi, Yasaman; Haghdoost, Afrooz

2015-12-01

The aim of this study was to assess validity of the fibromyalgia survey questionnaire (FSQ) and polysymptomatic distress scale (PSD) in an Iranian population. We also sought to classify the severity levels of fibromyalgia (FM) symptoms according to the PSD scale. Participants were divided into FM and non-FM chronic pain disorder groups according to expert physician diagnosis. Patients in both groups answered to Persian-translated version of FSQ, fibromyalgia impact questionnaire (FIQ) and Short-Form-12 (SF-12). Both 1990 ACR criteria and FSDC were assessed in participates of two groups. Internal consistency and construct validity were evaluated. There was good internal consistency measured by Cronbach's alpha (0.814 for FSQ). FSQ and its subscales correlated significantly with FIQ scores and SF-12 subscales, indicating acceptable construct validity. The concordance rates of FSQ with 1990 ACR criteria and expert diagnosis were 61.2 and 75.7, respectively (convergence validity). The mean score of PSD and its components in FM group were significantly more than in control groups (discriminative validity). Using lower PSD score cutoff (≥8.5) for the diagnosis of fibromyalgia appeared to be the most effective approach in our population. ROC analysis of the PSD scores revealed 8.5-11.5, 11.5-15 and more than 15, respectively, as a mild, moderate and severe FM. Persian version of FSQ was a valid instrument for application in survey research among Iranian patients with chronic pain disorders. The current study revealed that PSD could be used as a valid tool for assessment of symptoms intensity regardless of fibromyalgia diagnosis.

Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: recommendations of the International RDC/TMD Consortium Network* and Orofacial Pain Special Interest Group†.

Science.gov (United States)

Schiffman, Eric; Ohrbach, Richard; Truelove, Edmond; Look, John; Anderson, Gary; Goulet, Jean-Paul; List, Thomas; Svensson, Peter; Gonzalez, Yoly; Lobbezoo, Frank; Michelotti, Ambra; Brooks, Sharon L; Ceusters, Werner; Drangsholt, Mark; Ettlin, Dominik; Gaul, Charly; Goldberg, Louis J; Haythornthwaite, Jennifer A; Hollender, Lars; Jensen, Rigmor; John, Mike T; De Laat, Antoon; de Leeuw, Reny; Maixner, William; van der Meulen, Marylee; Murray, Greg M; Nixdorf, Donald R; Palla, Sandro; Petersson, Arne; Pionchon, Paul; Smith, Barry; Visscher, Corine M; Zakrzewska, Joanna; Dworkin, Samuel F

2014-01-01

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 ≥ 0.95. Consequently, these empirical results supported the development of revised RDC/TMD Axis I diagnostic algorithms that were subsequently demonstrated to be valid for the most common pain-related TMD and for one temporomandibular joint (TMJ) intra-articular disorder. The original RDC/TMD Axis II instruments were shown to be both reliable and valid. Working from these findings and revisions, two international consensus workshops were convened, from which recommendations were obtained for the finalization of new Axis I diagnostic algorithms and new Axis II instruments. Through a series of workshops and symposia, a panel of clinical and basic science pain experts modified the revised RDC/TMD Axis I algorithms by using comprehensive searches of published TMD diagnostic literature followed by review and consensus via a formal structured process. The panel's recommendations for further revision of the Axis I diagnostic algorithms were assessed for validity by using the Validation Project's data set, and for reliability by using newly collected data from the ongoing TMJ Impact Project-the follow-up study to the Validation Project. New Axis II instruments were identified through a comprehensive search 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. The newly recommended Diagnostic Criteria for TMD (DC/TMD) Axis I protocol includes both a valid screener for detecting any pain-related TMD as well as valid diagnostic criteria for differentiating the most common pain-related TMD (sensitivity ≥ 0.86, specificity ≥ 0.98) and for one intra

Validation of Standardized Questionnaires Evaluating Symptoms of Depression in Rheumatoid Arthritis Patients: Approaches to Screening for a Frequent Yet Underrated Challenge.

Science.gov (United States)

Englbrecht, Matthias; Alten, Rieke; Aringer, Martin; Baerwald, Christoph G; Burkhardt, Harald; Eby, Nancy; Fliedner, Gerhard; Gauger, Bettina; Henkemeier, Ulf; Hofmann, Michael W; Kleinert, Stefan; Kneitz, Christian; Krueger, Klaus; Pohl, Christoph; Roske, Anne-Eve; Schett, Georg; Schmalzing, Marc; Tausche, Anne-Kathrin; Peter Tony, Hans; Wendler, Joerg

2017-01-01

To validate standard self-report questionnaires for depression screening in patients with rheumatoid arthritis (RA) and compare these measures to one another and to the Montgomery-Åsberg Depression Rating Scale (MADRS), a standardized structured interview. In 9 clinical centers across Germany, depressive symptomatology was assessed in 262 adult RA patients at baseline (T0) and at 12 ± 2 weeks followup (T1) using the World Health Organization 5-Item Well-Being Index (WHO-5), the Patient Health Questionnaire (PHQ-9), and the Beck Depression Inventory II (BDI-II). The construct validity of these depression questionnaires (using convergent and discriminant validity) was evaluated using Spearman's correlations at both time points. The test-retest reliability of the questionnaires was evaluated in RA patients who had not undergone a psychotherapeutic intervention or received antidepressants between T0 and T1. The sensitivity and the specificity of the questionnaires were calculated using the results of the MADRS, a structured interview, as the gold standard. According to Spearman's correlation coefficients, all questionnaires met convergent validity criteria (ρ > |0.50|), with the BDI-II performing best, while correlations with age and disease activity for all questionnaires met the criteria for discriminant validity (ρ questionnaire to meet the predefined retest reliability criterion (ρ ≥ 0.70) was the BDI-II (r s  = 0.77), which also achieved the best results for both sensitivity and specificity (>80%) when using the MADRS as the gold standard. The BDI-II best met the predefined criteria, and the PHQ-9 met most of the validity criteria, with lower sensitivity and specificity. © 2016, American College of Rheumatology.

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

African Journals Online (AJOL)

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 ...

New criteria for inflammatory back pain in patients with chronic back pain: a real patient exercise by experts from the Assessment of SpondyloArthritis international Society (ASAS).

Science.gov (United States)

Sieper, J; van der Heijde, D; Landewé, R; Brandt, J; Burgos-Vagas, R; Collantes-Estevez, E; Dijkmans, B; Dougados, M; Khan, M A; Leirisalo-Repo, M; van der Linden, S; Maksymowych, W P; Mielants, H; Olivieri, I; Rudwaleit, M

2009-06-01

Inflammatory back pain (IBP) is an important clinical symptom in patients with axial spondyloarthritis (SpA), and relevant for classification and diagnosis. In the present report, a new approach for the development of IBP classification criteria is discussed. Rheumatologists (n = 13) who are experts in SpA took part in a 2-day international workshop to investigate 20 patients with back pain and possible SpA. Each expert documented the presence/absence of clinical parameters typical for IBP, and judged whether IBP was considered present or absent based on the received information. This expert judgement was used as the dependent variable in a logistic regression analysis in order to identify those individual IBP parameters that contributed best to a diagnosis of IBP. The new set of IBP criteria was validated in a separate cohort of patients (n = 648). Five parameters best explained IBP according to the experts. These were: (1) improvement with exercise (odds ratio (OR) 23.1); (2) pain at night (OR 20.4); (3) insidious onset (OR 12.7); (4) age at onset validation cohort. This new approach with real patients defines a set of IBP definition criteria using overall expert judgement on IBP as the gold standard. The IBP experts' criteria are robust, easy to apply and have good face validity.

International validation study for interim PET in ABVD-treated, advanced-stage hodgkin lymphoma

DEFF Research Database (Denmark)

Biggi, Alberto; Gallamini, Andrea; Chauvie, Stephane

2013-01-01

At present, there are no standard criteria that have been validated for interim PET reporting in lymphoma. In 2009, an international workshop attended by hematologists and nuclear medicine experts in Deauville, France, proposed to develop simple and reproducible rules for interim PET reporting...... in lymphoma. Accordingly, an international validation study was undertaken with the primary aim of validating the prognostic role of interim PET using the Deauville 5-point score to evaluate images and with the secondary aim of measuring concordance rates among reviewers using the same 5-point score...

Multi-criteria, personalized route planning using quantifier-guided ordered weighted averaging operators

Science.gov (United States)

Nadi, S.; Delavar, M. R.

2011-06-01

This paper presents a generic model for using different decision strategies in multi-criteria, personalized route planning. Some researchers have considered user preferences in navigation systems. However, these prior studies typically employed a high tradeoff decision strategy, which used a weighted linear aggregation rule, and neglected other decision strategies. The proposed model integrates a pairwise comparison method and quantifier-guided ordered weighted averaging (OWA) aggregation operators to form a personalized route planning method that incorporates different decision strategies. The model can be used to calculate the impedance of each link regarding user preferences in terms of the route criteria, criteria importance and the selected decision strategy. Regarding the decision strategy, the calculated impedance lies between aggregations that use a logical "and" (which requires all the criteria to be satisfied) and a logical "or" (which requires at least one criterion to be satisfied). The calculated impedance also includes taking the average of the criteria scores. The model results in multiple alternative routes, which apply different decision strategies and provide users with the flexibility to select one of them en-route based on the real world situation. The model also defines the robust personalized route under different decision strategies. The influence of different decision strategies on the results are investigated in an illustrative example. This model is implemented in a web-based geographical information system (GIS) for Isfahan in Iran and verified in a tourist routing scenario. The results demonstrated, in real world situations, the validity of the route planning carried out in the model.

Conception and validation of the Behavioral Intentions Scale of Organizational Citizenship (BISOC

Directory of Open Access Journals (Sweden)

Ana Cristina Passos Gomes Menezes

2016-01-01

Full Text Available Abstract This study aimed to construct and validate the Behavioral Intentions of Organizational Citizenship Scale (BISOC. Organizational citizenship consists of measures of voluntary behaviors, which are beneficial to organizations and are not explicit in employment contracts. To investigate the psychometric properties of BISOC, we selected 767 employees in different cities from the states of Bahia and Pernambuco (Brazil. The validation procedures adopted, which used techniques from both Classical Test Theory and Item Response Theory, showed that the BISOC has a unidimensional structure. From the initial set of 42 items, 35 items met the validation criteria. By presenting suitable psychometric parameters, BISOC is the first measure of organizational citizenship behaviors developed and validated to assess behavioral intentions.

Development and implementation of attractiveness Level E criteria and the plutonium disposition methodology

International Nuclear Information System (INIS)

Christensen, D.C.; Robinson, M.A.

1998-03-01

Historically, the Department of Energy used the Economic Discard Limits (EDLs), those Special Nuclear Material (SNM) concentrations in residue matrices below which production of new SNM was more economic than SNM recovery, as a basis for discard decisions. In 1994, a joint team from DOE Defense Programs (DP) and Environmental Management (EM) determined that the EDLs were no longer a valid discriminator and directed that SNM disposition consider instead 12 specific criteria, foremost of which are waste minimization, environmental impacts, safety, proliferation concerns, and cost. In response, the Los Alamos National Laboratory developed a technical basis for determining SNM bearing materials unattractive for proliferation purposes and a quantitative method for predicting materials disposition consequences as a basis for decision making called the plutonium disposition methodology. The objective of attractiveness Level E criteria is to insure that waste is unattractive for proliferation or terrorist purposes. Level E criteria is about 0.17 kg Pu per 208 liter drum (requiring diversion of a minimum of 54 drums, assuming 100% recovery efficiency)

Clinical and functional criteria for predicting asthma in infants

Directory of Open Access Journals (Sweden)

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.

Basic criteria for formation of growth twins in high stacking fault energy metals

International Nuclear Information System (INIS)

Yu, K. Y.; Zhang, X.; Bufford, D.; Chen, Y.; Liu, Y.; Wang, H.

2013-01-01

Nanotwinned metals received significant interest lately as twin boundaries may enable simultaneous enhancement of strength, ductility, thermal stability, and radiation tolerance. However, nanotwins have been the privilege of metals with low-to-intermediate stacking fault energy (SFE). Recent scattered studies show that nanotwins could be introduced into high SFE metals, such as Al. In this paper, we examine several sputter-deposited, (111) textured Ag/Al, Cu/Ni, and Cu/Fe multilayers, wherein growth twins were observed in Al, Ni, and face-centered cubic (fcc) Fe. The comparisons lead to two important design criteria that dictate the introduction of growth twins in high SFE metals. The validity of these criteria was then examined in Ag/Ni multilayers. Furthermore, another twin formation mechanism in high SFE metals was discovered in Ag/Ni system

Decision criteria in PSA applications

International Nuclear Information System (INIS)

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)

A new dataset validation system for the Planetary Science Archive

Science.gov (United States)

Manaud, N.; Zender, J.; Heather, D.; Martinez, S.

2007-08-01

The Planetary Science Archive is the official archive for the Mars Express mission. It has received its first data by the end of 2004. These data are delivered by the PI teams to the PSA team as datasets, which are formatted conform to the Planetary Data System (PDS). The PI teams are responsible for analyzing and calibrating the instrument data as well as the production of reduced and calibrated data. They are also responsible of the scientific validation of these data. ESA is responsible of the long-term data archiving and distribution to the scientific community and must ensure, in this regard, that all archived products meet quality. To do so, an archive peer-review is used to control the quality of the Mars Express science data archiving process. However a full validation of its content is missing. An independent review board recently recommended that the completeness of the archive as well as the consistency of the delivered data should be validated following well-defined procedures. A new validation software tool is being developed to complete the overall data quality control system functionality. This new tool aims to improve the quality of data and services provided to the scientific community through the PSA, and shall allow to track anomalies in and to control the completeness of datasets. It shall ensure that the PSA end-users: (1) can rely on the result of their queries, (2) will get data products that are suitable for scientific analysis, (3) can find all science data acquired during a mission. We defined dataset validation as the verification and assessment process to check the dataset content against pre-defined top-level criteria, which represent the general characteristics of good quality datasets. The dataset content that is checked includes the data and all types of information that are essential in the process of deriving scientific results and those interfacing with the PSA database. The validation software tool is a multi-mission tool that

The prevalence of polycystic ovary syndrome in a normal population according to the Rotterdam criteria versus revised criteria including anti-Mullerian hormone.

Science.gov (United States)

Lauritsen, M P; Bentzen, J G; Pinborg, A; Loft, A; Forman, J L; Thuesen, L L; Cohen, A; Hougaard, D M; Nyboe Andersen, A

2014-04-01

What is the prevalence in a normal population of polycystic ovary syndrome (PCOS) according to the Rotterdam criteria versus revised criteria including anti-Müllerian hormone (AMH)? The prevalence of PCOS was 16.6% according to the Rotterdam criteria. When replacing the criterion for polycystic ovaries by antral follicle count (AFC) > 19 or AMH > 35 pmol/l, the prevalence of PCOS was 6.3 and 8.5%, respectively. WHAT IS KNOWN ALREADY?: The Rotterdam criteria state that two out of the following three criteria should be present in the diagnosis of PCOS: oligo-anovulation, clinical and/or biochemical hyperandrogenism and polycystic ovaries (AFC ≥ 12 and/or ovarian volume >10 ml). However, with the advances in sonography, the relevance of the AFC threshold in the definition of polycystic ovaries has been challenged, and AMH has been proposed as a marker of polycystic ovaries in PCOS. From 2008 to 2010, a prospective, cross-sectional study was performed including 863 women aged 20-40 years and employed at Copenhagen University Hospital, Rigshospitalet, Denmark. We studied a subgroup of 447 women with a mean (±SD) age of 33.5 (±4.0) years who were all non-users of hormonal contraception. Data on menstrual cycle disorder and the presence of hirsutism were obtained. On cycle Days 2-5, or on a random day in the case of oligo- or amenorrhoea, sonographic and endocrine parameters were measured. The prevalence of PCOS was 16.6% according to the Rotterdam criteria. PCOS prevalence significantly decreased with age from 33.3% in women polycystic ovaries with a significant age-related decrease from 69.0% in women polycystic ovaries in women with PCOS according to the Rotterdam criteria [area under the curve (AUC) 0.994; 95% confidence interval (CI): 0.990-0.999] and AUC 0.992 (95% CI: 0.987-0.998), respectively], and an AMH cut-off value of 18 pmol/l and AMH Z-score of -0.2 showed the best compromise between sensitivity (91.8 and 90.4%, respectively) and specificity (98.1 and

Perspectives on the revised Ghent criteria for the diagnosis of Marfan syndrome

Science.gov (United States)

von Kodolitsch, Yskert; De Backer, Julie; Schüler, Helke; Bannas, Peter; Behzadi, Cyrus; Bernhardt, Alexander M; Hillebrand, Mathias; Fuisting, Bettina; Sheikhzadeh, Sara; Rybczynski, Meike; Kölbel, Tilo; Püschel, Klaus; Blankenberg, Stefan; Robinson, Peter N

2015-01-01

Three international nosologies have been proposed for the diagnosis of Marfan syndrome (MFS): the Berlin nosology in 1988; the Ghent nosology in 1996 (Ghent-1); and the revised Ghent nosology in 2010 (Ghent-2). We reviewed the literature and discussed the challenges and concepts of diagnosing MFS in adults. Ghent-1 proposed more stringent clinical criteria, which led to the confirmation of MFS in only 32%–53% of patients formerly diagnosed with MFS according to the Berlin nosology. Conversely, both the Ghent-1 and Ghent-2 nosologies diagnosed MFS, and both yielded similar frequencies of MFS in persons with a causative FBN1 mutation (90% for Ghent-1 versus 92% for Ghent-2) and in persons not having a causative FBN1 mutation (15% versus 13%). Quality criteria for diagnostic methods include objectivity, reliability, and validity. However, the nosology-based diagnosis of MFS lacks a diagnostic reference standard and, hence, quality criteria such as sensitivity, specificity, or accuracy cannot be assessed. Medical utility of diagnosis implies congruency with the historical criteria of MFS, as well as with information about the etiology, pathogenesis, diagnostic triggers, prognostic triggers, and potential complications of MFS. In addition, social and psychological utilities of diagnostic criteria include acceptance by patients, patient organizations, clinicians and scientists, practicability, costs, and the reduction of anxiety. Since the utility of a diagnosis or exclusion of MFS is context-dependent, prioritization of utilities is a strategic decision in the process of nosology development. Screening tests for MFS should be used to identify persons with MFS. To confirm the diagnosis of MFS, Ghent-1 and Ghent-2 perform similarly, but Ghent-2 is easier to use. To maximize the utility of the diagnostic criteria of MFS, a fair and transparent process of nosology development is essential. PMID:26124674

Reliability Criteria for Thick Bonding Wire.

Science.gov (United States)

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.

Reliability Criteria for Thick Bonding Wire

Science.gov (United States)

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

Criteria to Extract High-Quality Protein Data Bank Subsets for Structure Users.

Science.gov (United States)

Carugo, Oliviero; Djinović-Carugo, Kristina

2016-01-01

It is often necessary to build subsets of the Protein Data Bank to extract structural trends and average values. For this purpose it is mandatory that the subsets are non-redundant and of high quality. The first problem can be solved relatively easily at the sequence level or at the structural level. The second, on the contrary, needs special attention. It is not sufficient, in fact, to consider the crystallographic resolution and other feature must be taken into account: the absence of strings of residues from the electron density maps and from the files deposited in the Protein Data Bank; the B-factor values; the appropriate validation of the structural models; the quality of the electron density maps, which is not uniform; and the temperature of the diffraction experiments. More stringent criteria produce smaller subsets, which can be enlarged with more tolerant selection criteria. The incessant growth of the Protein Data Bank and especially of the number of high-resolution structures is allowing the use of more stringent selection criteria, with a consequent improvement of the quality of the subsets of the Protein Data Bank.

Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for clinical and research applications: recommendations of the international RDC/TMD consortium network and orofacial pain special interest group

NARCIS (Netherlands)

Schiffman, E.; Ohrbach, R.; Truelove, E.; Look, J.; Anderson, G.; Goulet, J.P.; List, T.; Svensson, P.; Gonzalez, Y.; Lobbezoo, F.; Michelotti, A.; Brooks, S.L.; Ceusters, W.; Drangsholt, M.; Ettlin, D.; Gaul, C.; Goldberg, L.J.; Haythornthwaite, J.A.; Hollender, L.; Jensen, R.; John, M.T.; De Laat, A.; de Leeuw, R.; Maixner, W.; van der Meulen, M.; Murray, G.M.; Nixdorf, D.R.; Palla, S.; Petersson, A.; Pionchon, P.; Smith, B.; Visscher, C.M.; Zakrzewska, J.; Dworkin, S.F.

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 ≥

Development of criteria for release of Idaho National Engineering Laboratory sites following decontamination and decommissioning

International Nuclear Information System (INIS)

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

[Factors and validity analysis of Mini-Mental State Examination in Chinese elderly people].

Science.gov (United States)

Gao, Ming-yue; Yang, Min; Kuang, Wei-hong; Qiu, Pei-yuan

2015-06-18

To examine factors that may have impact on the Mini-Mental State Examination (MMSE) screening validity, which could lead to further establishing the general model of the MMSE score in Chinese health elderly and to improve the screening accuracy of the existing MMSE reference. Based on the data of the Chinese Longitudinal Healthy Longevity Survey (CLHLS), the MMSE scores of 19,117 normal elderly and 137 dementia patients who met the inclusion criteria were used for the analysis. The area under the curve (AUC) and validity indexes were used to compare the screening accuracy of various criteria. Multiple linear regression was used to identify factors that had impact on the MMSE score for both the normal and dementia elderly. Descriptive analysis was performed for differences in the MMSE scores by age trends and gender between the normal and dementia elderly. The AUC of MMSE was ≥0.75(Pvalidity of MMSE in CLHLS is not affected by educational level. The analysis of factors that may impact on the MMSE screening validity are gender, age, vision and residence which with validity identification. These four factors can be used as assist tool of MMSE in the screening of dementia to improve the screening accuracy.

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

NARCIS (Netherlands)

Cluzeau, F.A.; Burgers, J.S.; Brouwers, M.M.; Grol, R.P.T.M.; et al.,

2003-01-01

BACKGROUND: International interest in clinical practice guidelines has never been greater but many published guidelines do not meet the basic quality requirements. There have been renewed calls for validated criteria to assess the quality of guidelines. OBJECTIVE: To develop and validate an

Modern digital plain-radiography of the whole spine in scoliosis patients. Dose reduction and quality criteria

International Nuclear Information System (INIS)

Kloth, Jost Karsten; Stiller, W.; Kauczor, H.U.; Weber, M.A.

2013-01-01

To reduce the radiation exposure of plain radiographs of the entire spine depending on specific indications, since these are frequently performed examinations of children and young adults with scoliosis and to determine objective quality control criteria to ensure accurate assessment. In this prospective randomized study 323 patients underwent plain-radiography of the entire spine with standard and 50 % reduced dose. In an experimental pilot-study this target-dose was determined using an Alderson-Phantom. The evaluation of the experimental radiographs, as well as, the randomized plain-radiographs was conducted using the following criteria: endplates (Cobb-angle), spinal process and pedicel (rotation), lateral margin of the vertebral body (lateral alignment), identification of C7 / S1 (perpendicular). Two radiologists evaluated these criteria using a score ranging from 1 (definitely assessable) to 4 (not assessable). If one single criteria was evaluated with a score of 3 or more points or more than 2 criteria with 2 points, the radiograph was scored as ''not assessable''. The statistical analysis was conducted as a non-inferiority-trial. Seven (2.4 %) of the 290 examined x-rays were scored as not assessable. There was no statistic inferiority between the examinations with standard or reduced dose, while singular assessment of the defined criteria was likewise dose-independent. Plain-radiography of the total spine in patients with scoliosis can be performed with a dose reduction of 50 % without a loss of validity. The obtained quality control criteria were clinically applicable. (orig.)

Toward criteria for pragmatic measurement in implementation research and practice: a stakeholder-driven approach using concept mapping.

Science.gov (United States)

Powell, Byron J; Stanick, Cameo F; Halko, Heather M; Dorsey, Caitlin N; Weiner, Bryan J; Barwick, Melanie A; Damschroder, Laura J; Wensing, Michel; Wolfenden, Luke; Lewis, Cara C

2017-10-03

Advancing implementation research and practice requires valid and reliable measures of implementation determinants, mechanisms, processes, strategies, and outcomes. However, researchers and implementation stakeholders are unlikely to use measures if they are not also pragmatic. The purpose of this study was to establish a stakeholder-driven conceptualization of the domains that comprise the pragmatic measure construct. It built upon a systematic review of the literature and semi-structured stakeholder interviews that generated 47 criteria for pragmatic measures, and aimed to further refine that set of criteria by identifying conceptually distinct categories of the pragmatic measure construct and providing quantitative ratings of the criteria's clarity and importance. Twenty-four stakeholders with expertise in implementation practice completed a concept mapping activity wherein they organized the initial list of 47 criteria into conceptually distinct categories and rated their clarity and importance. Multidimensional scaling, hierarchical cluster analysis, and descriptive statistics were used to analyze the data. The 47 criteria were meaningfully grouped into four distinct categories: (1) acceptable, (2) compatible, (3) easy, and (4) useful. Average ratings of clarity and importance at the category and individual criteria level will be presented. This study advances the field of implementation science and practice by providing clear and conceptually distinct domains of the pragmatic measure construct. Next steps will include a Delphi process to develop consensus on the most important criteria and the development of quantifiable pragmatic rating criteria that can be used to assess measures.

Evaluation of nonlinearity and validity of nonlinear modeling for complex time series.

Science.gov (United States)

Suzuki, Tomoya; Ikeguchi, Tohru; Suzuki, Masuo

2007-10-01

Even if an original time series exhibits nonlinearity, it is not always effective to approximate the time series by a nonlinear model because such nonlinear models have high complexity from the viewpoint of information criteria. Therefore, we propose two measures to evaluate both the nonlinearity of a time series and validity of nonlinear modeling applied to it by nonlinear predictability and information criteria. Through numerical simulations, we confirm that the proposed measures effectively detect the nonlinearity of an observed time series and evaluate the validity of the nonlinear model. The measures are also robust against observational noises. We also analyze some real time series: the difference of the number of chickenpox and measles patients, the number of sunspots, five Japanese vowels, and the chaotic laser. We can confirm that the nonlinear model is effective for the Japanese vowel /a/, the difference of the number of measles patients, and the chaotic laser.

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.

Science.gov (United States)

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.

Validation of metabolic syndrome using medical records in the SUN cohort

Directory of Open Access Journals (Sweden)

Barrio-Lopez Maria

2011-11-01

Full Text Available Abstract Background The objective of this study was to evaluate the validity of self reported criteria of Metabolic Syndrome (MS in the SUN (Seguimiento Universidad de Navarra cohort using their medical records as the gold standard. Methods We selected 336 participants and we obtained MS related data according to Adult Treatment Panel III (ATP III and International Diabetes Federation (IDF. Then we compared information on the self reported diagnosis of MS and MS diagnosed in their medical records. We calculated the proportion of confirmed MS, the proportion of confirmed non-MS and the intraclass correlation coefficients for each component of the MS. Results From those 336 selected participants, we obtained sufficient data in 172 participants to confirm or reject MS using ATP III criteria. The proportion of confirmed MS was 91.2% (95% CI: 80.7- 97.1 and the proportion of confirmed non-MS was 92.2% (95% CI: 85.7-96.4 using ATP III criteria. The proportion of confirmed MS using IDF criteria was 100% (95% CI: 87.2-100 and the proportion of confirmed non-MS was 97.1% (95% CI: 85.1-99.9. Kappa Index was 0.82 in the group diagnosed by ATP III criteria and 0.97 in the group diagnosed by IDF criteria. Intraclass correlation coefficients for the different component of MS were: 0.93 (IC 95%:0.91- 0.95 for BMI; 0.96 (IC 95%: 0.93-0.98 for waist circumference; 0.75 (IC 95%: 0.66-0.82 for fasting glucose; 0.50 (IC 95%:0.35-0.639 for HDL cholesterol; 0.78 (IC 95%: 0.70-0.84 for triglycerides; 0.49 (IC 95%:0.34-0.61 for systolic blood pressure and 0.55 (IC 95%: 0.41-0.65 for diastolic blood pressure. Conclusions Self-reported MS based on self reported components of the SM in a Spanish cohort of university graduates was sufficiently valid as to be used in epidemiological studies.

Diagnostic criteria for cryopyrin-associated periodic syndrome (CAPS).

Science.gov (United States)

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/.

Multi-criteria model for sustainable development using goal programming applied to the United Arab Emirates

International Nuclear Information System (INIS)

Jayaraman, Raja; Colapinto, Cinzia; Torre, Davide La; Malik, Tufail

2015-01-01

Sustainable development requires implementing suitable policies integrating several competing objectives on economic, environmental, energy and social criteria. Multi-Criteria Decision Analysis (MCDA) using goal programming is a popular and widely used technique to study decision problems in the face of multiple conflicting objectives. MCDA assists policy makers by providing clarity in choosing between alternatives for strategic planning and investments. In this paper, we propose a weighted goal programming model that integrates efficient allocation of resources to simultaneously achieve sustainability related goals on GDP growth, electricity consumption and GHG emissions. We validate the model with application to key economic sectors of the United Arab Emirates to achieve sustainable development goals by the year 2030. The model solution provides a quantitative justification and a basis for comparison in planning future energy requirements and an indispensable requirement to include renewable sources to satisfy long-term energy requirements. - Highlights: • Multi-criteria model for achieving sustainability goals by year 2030. • Integrates criteria on electricity, GDP, GHG emissions for optimal labor allocation. • Future electricity demand requires contribution from renewable sources • Enables planning for long term investments towards energy sustainability.

Validation of the Arabic Version of the Internet Gaming Disorder-20 Test.

Science.gov (United States)

Hawi, Nazir S; Samaha, Maya

2017-04-01

In recent years, researchers have been trying to shed light on gaming addiction and its association with different psychiatric disorders and psychological determinants. The latest edition version of the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) included in its Section 3 Internet Gaming Disorder (IGD) as a condition for further empirical study and proposed nine criteria for the diagnosis of IGD. The 20-item Internet Gaming Disorder (IGD-20) Test was developed as a valid and reliable tool to assess gaming addiction based on the nine criteria set by the DSM-5. The aim of this study is to validate an Arabic version of the IGD-20 Test. The Arabic version of IGD-20 will not only help in identifying Arabic-speaking pathological gamers but also stimulate cross-cultural studies that could contribute to an area in need of more research for insight and treatment. After a process of translation and back-translation and with the participation of a sizable sample of Arabic-speaking adolescents, the present study conducted a psychometric validation of the IGD-20 Test. Our confirmatory factor analysis showed the validity of the Arabic version of the IGD-20 Test. The one-factor model of the Arabic IGD-20 Test had very good psychometric properties, and it fitted the sample data extremely well. In addition, correlation analysis between the IGD-20 Test and the daily duration on weekdays and weekends gameplay revealed significant positive relationships that warranted a criterion-related validation. Thus, the Arabic version of the IGD-20 Test is a valid and reliable measure of IGD among Arabic-speaking populations.

Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: Recommendations of the International RDC/TMD Consortium Network* and Orofacial Pain Special Interest Group†

Science.gov (United States)

Schiffman, Eric; Ohrbach, Richard; Truelove, Edmond; Look, John; Anderson, Gary; Goulet, Jean-Paul; List, Thomas; Svensson, Peter; Gonzalez, Yoly; Lobbezoo, Frank; Michelotti, Ambra; Brooks, Sharon L.; Ceusters, Werner; Drangsholt, Mark; Ettlin, Dominik; Gaul, Charly; Goldberg, Louis J.; Haythornthwaite, Jennifer A.; Hollender, Lars; Jensen, Rigmor; John, Mike T.; De Laat, Antoon; de Leeuw, Reny; Maixner, William; van der Meulen, Marylee; Murray, Greg M.; Nixdorf, Donald R.; Palla, Sandro; Petersson, Arne; Pionchon, Paul; Smith, Barry; Visscher, Corine M.; Zakrzewska, Joanna; Dworkin, Samuel F.

2015-01-01

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 ≥ 0.95. Consequently, these empirical results supported the development of revised RDC/TMD Axis I diagnostic algorithms that were subsequently demonstrated to be valid for the most common pain-related TMD and for one temporomandibular joint (TMJ) intra-articular disorder. The original RDC/TMD Axis II instruments were shown to be both reliable and valid. Working from these findings and revisions, two international consensus workshops were convened, from which recommendations were obtained for the finalization of new Axis I diagnostic algorithms and new Axis II instruments. Methods Through a series of workshops and symposia, a panel of clinical and basic science pain experts modified the revised RDC/TMD Axis I algorithms by using comprehensive searches of published TMD diagnostic literature followed by review and consensus via a formal structured process. The panel's recommendations for further revision of the Axis I diagnostic algorithms were assessed for validity by using the Validation Project's data set, and for reliability by using newly collected data from the ongoing TMJ Impact Project—the follow-up study to the Validation Project. New Axis II instruments were identified through a comprehensive search 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 any pain-related TMD as well as valid diagnostic criteria for differentiating the most common pain-related TMD (sensitivity ≥ 0.86, specificity ≥ 0

Transferability of Skills: Convergent, Postdictive, Criterion-Related, and Construct Validation of Cross-Job Retraining Time Estimates

National Research Council Canada - National Science Library

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...

Evaluating terrain based criteria for snow avalanche exposure ratings using GIS

Science.gov (United States)

Delparte, Donna; Jamieson, Bruce; Waters, Nigel

2010-05-01

Snow avalanche terrain in backcountry regions of Canada is increasingly being assessed based upon the Avalanche Terrain Exposure Scale (ATES). ATES is a terrain based classification introduced in 2004 by Parks Canada to identify "simple", "challenging" and "complex" backcountry areas. The ATES rating system has been applied to well over 200 backcountry routes, has been used in guidebooks, trailhead signs and maps and is part of the trip planning component of the AVALUATOR™, a simple decision-support tool for backcountry users. Geographic Information Systems (GIS) offers a means to model and visualize terrain based criteria through the use of digital elevation model (DEM) and land cover data. Primary topographic variables such as slope, aspect and curvature are easily derived from a DEM and are compatible with the equivalent evaluation criteria in ATES. Other components of the ATES classification are difficult to extract from a DEM as they are not strictly terrain based. An overview is provided of the terrain variables that can be generated from DEM and land cover data; criteria from ATES which are not clearly terrain based are identified for further study or revision. The second component of this investigation was the development of an algorithm for inputting suitable ATES criteria into a GIS, thereby mimicking the process avalanche experts use when applying the ATES classification to snow avalanche terrain. GIS based classifications were compared to existing expert assessments for validity. The advantage of automating the ATES classification process through GIS is to assist avalanche experts with categorizing and mapping remote backcountry terrain.

Development and Validation of a Tool for Measurement of Patient Satisfaction with Nursing Care at Oak Hill Hospital.

Science.gov (United States)

Callow, Elizabeth K.

The Department of Nursing at Oak Hill Hospital, Spring Hill (Florida) did not have a measurement instrument for patient evaluation of hospital nursing services. An instrument to measure patient satisfaction with nursing was developed and validated. Criteria identified through a literature search were reviewed, modified, and validated by a…

Rating of environmental criteria

Energy Technology Data Exchange (ETDEWEB)

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.

The Validity and Responsiveness of Isometric Lower Body Multi-Joint Tests of Muscular Strength: a Systematic Review.

Science.gov (United States)

Drake, David; Kennedy, Rodney; Wallace, Eric

2017-12-01

Researchers and practitioners working in sports medicine and science require valid tests to determine the effectiveness of interventions and enhance understanding of mechanisms underpinning adaptation. Such decision making is influenced by the supportive evidence describing the validity of tests within current research. The objective of this study is to review the validity of lower body isometric multi-joint tests ability to assess muscular strength and determine the current level of supporting evidence. Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines were followed in a systematic fashion to search, assess and synthesize existing literature on this topic. Electronic databases such as Web of Science, CINAHL and PubMed were searched up to 18 March 2015. Potential inclusions were screened against eligibility criteria relating to types of test, measurement instrument, properties of validity assessed and population group and were required to be published in English. The Consensus-based Standards for the Selection of health Measurement Instruments (COSMIN) checklist was used to assess methodological quality and measurement property rating of included studies. Studies rated as fair or better in methodological quality were included in the best evidence synthesis. Fifty-nine studies met the eligibility criteria for quality appraisal. The ten studies that rated fair or better in methodological quality were included in the best evidence synthesis. The most frequently investigated lower body isometric multi-joint tests for validity were the isometric mid-thigh pull and isometric squat. The validity of each of these tests was strong in terms of reliability and construct validity. The evidence for responsiveness of tests was found to be moderate for the isometric squat test and unknown for the isometric mid-thigh pull. No tests using the isometric leg press met the criteria for inclusion in the best evidence synthesis. Researchers and

Are validated patient-reported outcomes used on children in pediatric otolaryngology? A systematic review.

Science.gov (United States)

Wong, Kevin; Piraquive, Jacquelyn; Troiano, Chelsea A; Sulibhavi, Anita; Grundfast, Kenneth M; Levi, Jessica R

2018-02-01

Review the pediatric otolaryngology literature to 1) identify studies in which children completed patient-reported outcome (PRO) measures and 2) appraise the psychometric quality and validity of these PROs as they apply to pediatrics. In October 2016, a systematic review was performed by two reviewers on PubMed/MEDLINE and EMBASE for all otolaryngology-related studies that utilized PROs in children. Inclusion criteria included articles that required children (ageotolaryngology and some studies utilized PROs that were not validated or not validated for use in this age group. Future efforts to design and validate more instruments may be warranted. Copyright © 2017. Published by Elsevier B.V.

Criteria required for an acceptable point-of-care test for UTI detection: Obtaining consensus using the Delphi technique.

Science.gov (United States)

Weir, Nichola-Jane M; Pattison, Sally H; Kearney, Paddy; Stafford, Bob; Gormley, Gerard J; Crockard, Martin A; Gilpin, Deirdre F; Tunney, Michael M; Hughes, Carmel M

2018-01-01

Urinary Tract Infections (UTIs) are common bacterial infections, second only to respiratory tract infections and particularly prevalent within primary care. Conventional detection of UTIs is culture, however, return of results can take between 24 and 72 hours. The introduction of a point of care (POC) test would allow for more timely identification of UTIs, facilitating improved, targeted treatment. This study aimed to obtain consensus on the criteria required for a POC UTI test, to meet patient need within primary care. Criteria for consideration were compiled by the research team. These criteria were validated through a two-round Delphi process, utilising an expert panel of healthcare professionals from across Europe and United States of America. Using web-based questionnaires, panellists recorded their level of agreement with each criterion based on a 5-point Likert Scale, with space for comments. Using median response, interquartile range and comments provided, criteria were accepted/rejected/revised depending on pre-agreed cut-off scores. The first round questionnaire presented thirty-three criteria to the panel, of which 22 were accepted. Consensus was not achieved for the remaining 11 criteria. Following response review, one criterion was removed, while after revision, the remaining 10 criteria entered the second round. Of these, four were subsequently accepted, resulting in 26 criteria considered appropriate for a POC test to detect urinary infections. This study generated an approved set of criteria for a POC test to detect urinary infections. Criteria acceptance and comments provided by the healthcare professionals also supports the development of a multiplex point of care UTI test.

Analysing and Comparing Encodability Criteria

Directory of Open Access Journals (Sweden)

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.

UNDEUTSCH HYPOTHESIS AND CRITERIA BASED CONTENT ANALYSIS: A META-ANALYTIC REVIEW

Directory of Open Access Journals (Sweden)

Bárbara G. Amado

2015-01-01

Full Text Available The credibility of a testimony is a crucial component of judicial decision-making. Checklists of testimony credibility criteria are extensively used by forensic psychologists to assess the credibility of a testimony, and in many countries they are admitted as valid scientific evidence in a court of law. These checklists are based on the Undeutsch hypothesis asserting that statements derived from the memory of real-life experiences differ significantly in content and quality from fabricated or fictitious accounts. Notwithstanding, there is considerable controversy regarding the degree to which these checklists comply with the legal standards for scientific evidence to be admitted in a court of law (e.g., Daubert standards. In several countries, these checklists are not admitted as valid evidence in court, particularly in view of the inconsistent results reported in the scientific literature. Bearing in mind these issues, a meta-analysis was designed to test the Undeutsch hypothesis using the CBCA Checklist of criteria to discern between memories of self-experienced real-life events and fabricated or fictitious accounts. As the original hypothesis was formulated for populations of children, only quantitative studies with samples of children were considered for this study. In line with the Undeutsch hypothesis, the results showed a significant positive effect size that is generalizable to the total CBCA score, δ = 0.79. Moreover, a significant positive effect size was observed in each and all of the credibility criteria. In conclusion, the results corroborated the validity of the Undeutsch hypothesis and the CBCA criteria for discriminating between the memory of real self-experienced events and false or invented accounts. The results are discussed in terms of the implications for forensic practice. Con frecuencia, la evaluación de la fiabilidad de un testimonio se lleva a cabo mediante el uso de sistemas categoriales de análisis de contenido

Reliability Criteria for Thick Bonding Wire

Directory of Open Access Journals (Sweden)

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.

Validation of Biofeedback Wearables for Photoplethysmographic Heart Rate Tracking

Directory of Open Access Journals (Sweden)

Edward Jo, Kiana Lewis, Dean Directo, Michael J. Kim, Brett A. Dolezal

2016-09-01

Full Text Available The purpose of this study was to examine the validity of HR measurements by two commercial-use activity trackers in comparison to ECG. Twenty-four healthy participants underwent the same 77-minute protocol during a single visit. Each participant completed an initial rest period of 15 minutes followed by 5 minute periods of each of the following activities: 60W and 120W cycling, walking, jogging, running, resisted arm raises, resisted lunges, and isometric plank. In between each exercise task was a 5-minute rest period. Each subject wore a Basis Peak (BPk on one wrist and a Fitbit Charge HR (FB on the opposite wrist. Criterion measurement of HR was administered by 12-lead ECG. Time synced data from each device and ECG were concurrently and electronically acquired throughout the entire 77-minute protocol. When examining data in aggregate, there was a strong correlation between BPk and ECG for HR (r = 0.92, p 116 bpm, the BPk demonstrated an r = 0.77 and mean bias = -4.9 bpm (95% LoA 21.3, -31.0 while the FB demonstrated an r = 0.58 and mean bias = -12.7 bpm (95% LoA 28.6, -54.0. The BPk satisfied validity criteria for HR monitors, however showed a marginal decline in accuracy with increasing physical effort (ECG HR > 116 bpm. The FB failed to satisfy validity criteria and demonstrated a substantial decrease in accuracy during higher exercise intensities.

Diagnostic Criteria for Pediatric MS

Directory of Open Access Journals (Sweden)

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.

Bi-criteria evaluation of the MIKE SHE model for a forested watershed on the South Carolina coastal plain

Directory of Open Access Journals (Sweden)

Z. Dai

2010-06-01

Full Text Available Hydrological models are important tools for effective management, conservation and restoration of forested wetlands. The objective of this study was to test a distributed hydrological model, MIKE SHE, by using bi-criteria (i.e., two measurable variables, streamflow and water table depth to describe the hydrological processes in a forested watershed that is characteristic of the lower Atlantic Coastal Plain. Simulations were compared against observations of both streamflow and water table depth measured on a first-order watershed (WS80 on the Santee Experimental Forest in South Carolina, USA. Model performance was evaluated using coefficient of determination (R² and Nash-Sutcliffe's model efficiency (E. The E and root mean squared error (RMSE were chosen as objective functions for sensitivity analysis of parameters. The model calibration and validation results demonstrated that the streamflow and water table depth were sensitive to most of the model input parameters, especially to surface detention storage, drainage depth, soil hydraulic properties, plant rooting depth, and surface roughness. Furthermore, the bi-criteria approach used for distributed model calibration and validation was shown to be better than the single-criterion in obtaining optimum model input parameters, especially for those parameters that were only sensitive to some specific conditions. Model calibration using the bi-criteria approach should be advantageous for constructing the uncertainty bounds of model inputs to simulate the hydrology for this type of forested watersheds. R² varied from 0.60–0.99 for daily and monthly streamflow, and from 0.52–0.91 for daily water table depth. E changed from 0.53–0.96 for calibration and 0.51–0.98 for validation of daily and monthly streamflow, while E varied from 0.50–0.90 for calibration and 0.66–0.80 for validation of daily water table depth. This study showed

Validity of dementia diagnoses in the danish hospital registers

DEFF Research Database (Denmark)

Phung, T.K.T.; Andersen, B.B.; Phung, T.K.T.

2007-01-01

.24-0.48). Conclusion: The validity of dementia syndrome in the Danish hospital registers was high and allows for epidemiological studies about dementia. Alzheimer's disease, although underregistered, also had a good validity once the diagnosis was registered. In general, other ICD-10 dementia subtypes in the registers......Background:The validity of dementia diagnoses in the Danish nationwide hospital registers was evaluated to determine the value of these registers in epidemiological research about dementia. Methods: Two hundred patients were randomly selected from 4,682 patients registered for the first time...... with a dementia diagnosis in the last 6 months of 2003. The patients' medical journals were reviewed to evaluate if they fulfilled ICD-10 and/or DSM-IV criteria for dementia and specific dementia subtypes. The patients who were still alive in 2006 were invited to an interview. Results: One hundred and ninety...

The prevalence of polycystic ovary syndrome in a normal population according to the Rotterdam criteria versus revised criteria including anti-Müllerian hormone

DEFF Research Database (Denmark)

Lauritsen, M P; Bentzen, J G; Pinborg, A

2014-01-01

-anovulation, clinical and/or biochemical hyperandrogenism and polycystic ovaries (AFC ≥ 12 and/or ovarian volume >10 ml). However, with the advances in sonography, the relevance of the AFC threshold in the definition of polycystic ovaries has been challenged, and AMH has been proposed as a marker of polycystic ovaries...... ovaries with a significant age-related decrease from 69.0% in women reliable marker of polycystic ovaries in women with PCOS according to the Rotterdam criteria [area....... However, future studies are needed to validate AMH threshold levels, and AMH Z-score may be appropriate to adjust for the age-related decline in the AFC. STUDY FUNDING/COMPETING INTEREST(S): None. TRIAL REGISTRATION NUMBER: Not applicable....

Enhanced seismic criteria for piping

International Nuclear Information System (INIS)

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

Validation of biomarkers for the study of environmental carcinogens: a review

DEFF Research Database (Denmark)

Gallo, Valentina; Khan, Aneire; Gonzales, Carlos

2008-01-01

There is a need for validation of biomarkers. Our aim is to review published work on the validation of selected biomarkers: bulky DNA adducts, N-nitroso compounds, 1-hydroxypyrene, and oxidative damage to DNA. A systematic literature search in PubMed was performed. Information on the variability...... and reliability of the laboratory tests used for biomarkers measurements was collected. For the evaluation of the evidence on validation we referred to the ACCE criteria. Little is known about intraindividual variation of DNA adduct measurements, but measurements have a good repeatability irrespective...... of the technique used for their identification; reproducibility improved after the correction for a laboratory factor. A high-sensitivity method is available for the measurement of 1-hydroxypyrene in urine. There is consensus on validation of biomarkers of oxidative damage DNA based on the comet assay...

Development and Preliminary Validation of the Time Management for Exercise Scale

Science.gov (United States)

Hellsten, Laurie-ann M.; Rogers, W. Todd

2009-01-01

The purpose of this study was to collect preliminary validity evidence for a time management scale for exercise. An initial pool of 91 items was developed from existing literature. Ten exercise/health psychologists evaluated each of the items in terms of relevance and representativeness. Forty-nine items met all criteria. Exploratory factor…

Validation of diabetes mellitus and hypertension diagnosis in computerized medical records in primary health care

Directory of Open Access Journals (Sweden)

Abánades-Herranz Juan C

2011-10-01

Full Text Available Abstract Background Computerized Clinical Records, which are incorporated in primary health care practice, have great potential for research. In order to use this information, data quality and reliability must be assessed to prevent compromising the validity of the results. The aim of this study is to validate the diagnosis of hypertension and diabetes mellitus in the computerized clinical records of primary health care, taking the diagnosis criteria established in the most prominently used clinical guidelines as the gold standard against which what measure the sensitivity, specificity, and determine the predictive values. The gold standard for diabetes mellitus was the diagnostic criteria established in 2003 American Diabetes Association Consensus Statement for diabetic subjects. The gold standard for hypertension was the diagnostic criteria established in the Joint National Committee published in 2003. Methods A cross-sectional multicentre validation study of diabetes mellitus and hypertension diagnoses in computerized clinical records of primary health care was carried out. Diagnostic criteria from the most prominently clinical practice guidelines were considered for standard reference. Sensitivity, specificity, positive and negative predictive values, and global agreement (with kappa index, were calculated. Results were shown overall and stratified by sex and age groups. Results The agreement for diabetes mellitus with the reference standard as determined by the guideline was almost perfect (κ = 0.990, with a sensitivity of 99.53%, a specificity of 99.49%, a positive predictive value of 91.23% and a negative predictive value of 99.98%. Hypertension diagnosis showed substantial agreement with the reference standard as determined by the guideline (κ = 0.778, the sensitivity was 85.22%, the specificity 96.95%, the positive predictive value 85.24%, and the negative predictive value was 96.95%. Sensitivity results were worse in patients who

Guidance for the definition and application of probabilistic safety criteria

International Nuclear Information System (INIS)

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)

Guidance for the definition and application of probabilistic safety criteria

Energy Technology Data Exchange (ETDEWEB)

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)

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)

Science.gov (United States)

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