40 CFR 86.1341-98 - Test cycle validation criteria.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 20 2012-07-01 2012-07-01 false Test cycle validation criteria. 86... Procedures § 86.1341-98 Test cycle validation criteria. Section 86.1341-98 includes text that specifies...-90 (d)(4), shall be excluded from both cycle validation and the integrated work used for emissions...

40 CFR 86.1341-98 - Test cycle validation criteria.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 20 2013-07-01 2013-07-01 false Test cycle validation criteria. 86... Procedures § 86.1341-98 Test cycle validation criteria. Section 86.1341-98 includes text that specifies...-90 (d)(4), shall be excluded from both cycle validation and the integrated work used for emissions...

40 CFR 86.1341-98 - Test cycle validation criteria.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 19 2011-07-01 2011-07-01 false Test cycle validation criteria. 86... Procedures § 86.1341-98 Test cycle validation criteria. Section 86.1341-98 includes text that specifies...-90 (d)(4), shall be excluded from both cycle validation and the integrated work used for emissions...

78 FR 38411 - Vogtle Electric Generating Plant, Unit 4; Inspections, Tests, Analyses, and Acceptance Criteria

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-26

... Plant, Unit 4; Inspections, Tests, Analyses, and Acceptance Criteria AGENCY: Nuclear Regulatory Commission. ACTION: Determination of inspections, tests, analyses, and acceptance criteria completion. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) staff has determined that the inspections, tests...

Validity and Reliability of the Turkish Chronic Pain Acceptance Questionnaire

PubMed

Akmaz, Hazel Ekin; Uyar, Meltem; Kuzeyli Yıldırım, Yasemin; Akın Korhan, Esra

2018-05-29

Pain acceptance is the process of giving up the struggle with pain and learning to live a worthwhile life despite it. In assessing patients with chronic pain in Turkey, making a diagnosis and tracking the effectiveness of treatment is done with scales that have been translated into Turkish. However, there is as yet no valid and reliable scale in Turkish to assess the acceptance of pain. To validate a Turkish version of the Chronic Pain Acceptance Questionnaire developed by McCracken and colleagues. Methodological and cross sectional study. A simple randomized sampling method was used in selecting the study sample. The sample was composed of 201 patients, more than 10 times the number of items examined for validity and reliability in the study, which totaled 20. A patient identification form, the Chronic Pain Acceptance Questionnaire, and the Brief Pain Inventory were used to collect data. Data were collected by face-to-face interviews. In the validity testing, the content validity index was used to evaluate linguistic equivalence, content validity, construct validity, and expert views. In reliability testing of the scale, Cronbach’s α coefficient was calculated, and item analysis and split-test reliability methods were used. Principal component analysis and varimax rotation were used in factor analysis and to examine factor structure for construct concept validity. The item analysis established that the scale, all items, and item-total correlations were satisfactory. The mean total score of the scale was 21.78. The internal consistency coefficient was 0.94, and the correlation between the two halves of the scale was 0.89. The Chronic Pain Acceptance Questionnaire, which is intended to be used in Turkey upon confirmation of its validity and reliability, is an evaluation instrument with sufficient validity and reliability, and it can be reliably used to examine patients’ acceptance of chronic pain.

Reinforced concrete pipe cracks : acceptance criteria [revised July 29, 2011].

DOT National Transportation Integrated Search

2011-07-01

Inspection of recently placed reinforced concrete pipes often reveals cracks. Florida DOT was in : need of in-place crack acceptance criteria. This project was intended to determine the influential parameters : responsible for crack healing in in-pla...

40 CFR 86.1341-98 - Test cycle validation criteria.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 19 2010-07-01 2010-07-01 false Test cycle validation criteria. 86...) Emission Regulations for New Otto-Cycle and Diesel Heavy-Duty Engines; Gaseous and Particulate Exhaust Test Procedures § 86.1341-98 Test cycle validation criteria. Section 86.1341-98 includes text that specifies...

Validity and Reliability of the Turkish Chronic Pain Acceptance Questionnaire

PubMed Central

Akmaz, Hazel Ekin; Uyar, Meltem; Kuzeyli Yıldırım, Yasemin; Akın Korhan, Esra

2018-01-01

Background: Pain acceptance is the process of giving up the struggle with pain and learning to live a worthwhile life despite it. In assessing patients with chronic pain in Turkey, making a diagnosis and tracking the effectiveness of treatment is done with scales that have been translated into Turkish. However, there is as yet no valid and reliable scale in Turkish to assess the acceptance of pain. Aims: To validate a Turkish version of the Chronic Pain Acceptance Questionnaire developed by McCracken and colleagues. Study Design: Methodological and cross sectional study. Methods: A simple randomized sampling method was used in selecting the study sample. The sample was composed of 201 patients, more than 10 times the number of items examined for validity and reliability in the study, which totaled 20. A patient identification form, the Chronic Pain Acceptance Questionnaire, and the Brief Pain Inventory were used to collect data. Data were collected by face-to-face interviews. In the validity testing, the content validity index was used to evaluate linguistic equivalence, content validity, construct validity, and expert views. In reliability testing of the scale, Cronbach’s α coefficient was calculated, and item analysis and split-test reliability methods were used. Principal component analysis and varimax rotation were used in factor analysis and to examine factor structure for construct concept validity. Results: The item analysis established that the scale, all items, and item-total correlations were satisfactory. The mean total score of the scale was 21.78. The internal consistency coefficient was 0.94, and the correlation between the two halves of the scale was 0.89. Conclusion: The Chronic Pain Acceptance Questionnaire, which is intended to be used in Turkey upon confirmation of its validity and reliability, is an evaluation instrument with sufficient validity and reliability, and it can be reliably used to examine patients’ acceptance of chronic pain

40 CFR 86.1341-90 - Test cycle validation criteria.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 19 2010-07-01 2010-07-01 false Test cycle validation criteria. 86...) Emission Regulations for New Otto-Cycle and Diesel Heavy-Duty Engines; Gaseous and Particulate Exhaust Test Procedures § 86.1341-90 Test cycle validation criteria. (a) To minimize the biasing effect of the time lag...

Face Validity of Test and Acceptance of Generalized Personality Interpretations

ERIC Educational Resources Information Center

Delprato, Dennis J.

1975-01-01

The degree to which variations in the face validity of psychological tests affected students' willingness to accept personality interpretations was studied. Acceptance of personality interpretations was compared for four types of tests which varied in face validity. The relationship between judged accuracy and rated likability of the…

40 CFR 90.510 - Compliance with acceptable quality level and passing and failing criteria for selective...

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 20 2011-07-01 2011-07-01 false Compliance with acceptable quality level and passing and failing criteria for selective enforcement audits. 90.510 Section 90.510....510 Compliance with acceptable quality level and passing and failing criteria for selective...

40 CFR 91.608 - Compliance with acceptable quality level and passing and failing criteria for selective...

Code of Federal Regulations, 2011 CFR

2011-07-01

... level and passing and failing criteria for selective enforcement audits. 91.608 Section 91.608... with acceptable quality level and passing and failing criteria for selective enforcement audits. (a) The prescribed acceptable quality level is 40 percent. (b) A failed engine is one whose final test...

40 CFR 89.510 - Compliance with acceptable quality level and passing and failing criteria for selective...

Code of Federal Regulations, 2013 CFR

2013-07-01

... level and passing and failing criteria for selective enforcement audits. 89.510 Section 89.510... Compliance with acceptable quality level and passing and failing criteria for selective enforcement audits. (a) The prescribed acceptable quality level is 40 percent. (b) A failed engine is one whose final...

40 CFR 89.510 - Compliance with acceptable quality level and passing and failing criteria for selective...

Code of Federal Regulations, 2014 CFR

2014-07-01

... level and passing and failing criteria for selective enforcement audits. 89.510 Section 89.510... Compliance with acceptable quality level and passing and failing criteria for selective enforcement audits. (a) The prescribed acceptable quality level is 40 percent. (b) A failed engine is one whose final...

40 CFR 91.608 - Compliance with acceptable quality level and passing and failing criteria for selective...

Code of Federal Regulations, 2014 CFR

2014-07-01

... level and passing and failing criteria for selective enforcement audits. 91.608 Section 91.608... with acceptable quality level and passing and failing criteria for selective enforcement audits. (a) The prescribed acceptable quality level is 40 percent. (b) A failed engine is one whose final test...

40 CFR 91.608 - Compliance with acceptable quality level and passing and failing criteria for selective...

Code of Federal Regulations, 2013 CFR

2013-07-01

... level and passing and failing criteria for selective enforcement audits. 91.608 Section 91.608... with acceptable quality level and passing and failing criteria for selective enforcement audits. (a) The prescribed acceptable quality level is 40 percent. (b) A failed engine is one whose final test...

Preliminary operational requirements and acceptability criteria for the cooperative breath analyzer

DOT National Transportation Integrated Search

1971-09-01

This report presents a series of criteria and requirements relevant to establishing user acceptability for the cooperative alcohol analyzer being developed by the Transportation Systems Center. The information presented herein was obtained with the c...

Validation of the process criteria for assessment of a hospital nursing service.

PubMed

Feldman, Liliane Bauer; Cunha, Isabel Cristina Kowal Olm; D'Innocenzo, Maria

2013-01-01

to validate an instrument containing process criteria for assessment of a hospital nursing service based on the National Accreditation Organization program. a descriptive, quantitative methodological study performed in stages. An instrument constructed with 69 process criteria was assessed by 49 nurses from accredited hospitals in 2009, according to a Likert scale, and validated by 16 judges through Delphi rounds in 2010. the original instrument assessed by nurses with 69 process criteria was judged by the degree of importance, and changed to 39 criteria. In the first Delphi round, the 39 criteria reached consensus among the 19 judges, with a medium reliability by Cronbach's alpha. In the second round, 40 converging criteria were validated by 16 judges, with high reliability. The criteria addressed management, costs, teaching, education, indicators, protocols, human resources, communication, among others. the 40 process criteria formed a validated instrument to assess the hospital nursing service which, when measured, can better direct interventions by nurses in reaching and strengthening outcomes.

10 CFR 50.60 - Acceptance criteria for fracture prevention measures for lightwater nuclear power reactors for...

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 1 2013-01-01 2013-01-01 false Acceptance criteria for fracture prevention measures for... of Licenses and Construction Permits § 50.60 Acceptance criteria for fracture prevention measures for... certifications required under § 50.82(a)(1) have been submitted, must meet the fracture toughness and material...

10 CFR 50.60 - Acceptance criteria for fracture prevention measures for lightwater nuclear power reactors for...

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 1 2014-01-01 2014-01-01 false Acceptance criteria for fracture prevention measures for... of Licenses and Construction Permits § 50.60 Acceptance criteria for fracture prevention measures for... certifications required under § 50.82(a)(1) have been submitted, must meet the fracture toughness and material...

10 CFR 50.60 - Acceptance criteria for fracture prevention measures for lightwater nuclear power reactors for...

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 1 2012-01-01 2012-01-01 false Acceptance criteria for fracture prevention measures for... of Licenses and Construction Permits § 50.60 Acceptance criteria for fracture prevention measures for... certifications required under § 50.82(a)(1) have been submitted, must meet the fracture toughness and material...

46 CFR 54.05-17 - Weld toughness test acceptance criteria.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 2 2010-10-01 2010-10-01 false Weld toughness test acceptance criteria. 54.05-17 Section 54.05-17 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING... impact tests the energy absorbed in both the weld metal and heat affected zone impact tests in weld...

46 CFR 54.05-17 - Weld toughness test acceptance criteria.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 46 Shipping 2 2011-10-01 2011-10-01 false Weld toughness test acceptance criteria. 54.05-17 Section 54.05-17 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING... impact tests the energy absorbed in both the weld metal and heat affected zone impact tests in weld...

46 CFR 54.05-17 - Weld toughness test acceptance criteria.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 46 Shipping 2 2012-10-01 2012-10-01 false Weld toughness test acceptance criteria. 54.05-17 Section 54.05-17 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING... impact tests the energy absorbed in both the weld metal and heat affected zone impact tests in weld...

46 CFR 54.05-17 - Weld toughness test acceptance criteria.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 46 Shipping 2 2013-10-01 2013-10-01 false Weld toughness test acceptance criteria. 54.05-17 Section 54.05-17 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING... impact tests the energy absorbed in both the weld metal and heat affected zone impact tests in weld...

46 CFR 54.05-17 - Weld toughness test acceptance criteria.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 46 Shipping 2 2014-10-01 2014-10-01 false Weld toughness test acceptance criteria. 54.05-17 Section 54.05-17 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING... impact tests the energy absorbed in both the weld metal and heat affected zone impact tests in weld...

Examining the diagnostic criteria for Internet addiction: Expert validation.

PubMed

Hsu, Wen-Yu; Lin, Sunny S J; Chang, Shan-Mei; Tseng, Yin-Hsing; Chiu, Nan-Ying

2015-06-01

Internet addiction is the coming problem around the world. The diagnostic criteria for Internet addiction among adolescents (DC-IA-A) has become a widely used measure for assessing the presence of Internet addiction in Taiwan. This study examined the diagnosis criteria for Internet addiction in adolescents by expert evaluation. Twenty psychiatrists rated the adequacy of each criterion in DC-IA-A. The content validity and homogeneity reliability proposed by Aiken were calculated. The coefficients content validity and homogeneity reliability showed twenty psychiatrists agreed on each of DC-IA-A as relevant to the diagnosis of Internet addiction, though several criteria need improvements. Two criteria "excessive time spent on Internet activities and leaving the Internet" and "excessive effort spent on activities necessary to obtain access to the Internet" should be omitted, and the criteria of "tolerance" should be modified. The diagnostic criteria for Internet addiction among adolescents should be revised to meet the real condition of this population. Copyright © 2014. Published by Elsevier B.V.

10 CFR 50.46a - Acceptance criteria for reactor coolant system venting systems.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false Acceptance criteria for reactor coolant system venting... criteria for reactor coolant system venting systems. Each nuclear power reactor must be provided with high point vents for the reactor coolant system, for the reactor vessel head, and for other systems required...

10 CFR 50.46a - Acceptance criteria for reactor coolant system venting systems.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 1 2011-01-01 2011-01-01 false Acceptance criteria for reactor coolant system venting... criteria for reactor coolant system venting systems. Each nuclear power reactor must be provided with high point vents for the reactor coolant system, for the reactor vessel head, and for other systems required...

Corrosion control acceptance criteria for sacrificial anode type, cathodic protection systems (user guide)

NASA Astrophysics Data System (ADS)

Hock, Vincent F.; Noble, Michael; McLeod, Malcolm E.

1994-07-01

The Army currently operates and maintains more than 20,000 underground storage tanks and over 3000 miles of underground gas pipelines, all of which require some form of corrosion control. Cathodic protection is one method of corrosion control used to prevent corrosion-induced leaks when a steel structure is exposed to an aggressive soil. The corrosion control acceptance criteria for sacrificial anode type CP systems provides guidelines for the DEH/DPW cathodic protection installation inspectors whose responsibilities are to ensure that the materials and equipment specified are delivered to the job site and subsequently installed in accordance with the engineering drawings and specifications. The sacrificial anode CP acceptance criteria includes all components for the sacrificial anode system such as insulated conductors, anodes, anode backfills, and auxiliary equipment. The sacrificial anode CP acceptance criteria is composed of a checklist that lists each component and that contains a space for the inspector to either check 'yes' or 'no' to indicate whether the component complies with the job specifications. In some cases, the inspector must measure and record physical dimensions or electrical output and compare the measurements to standards shown in attached tables.

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

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 34 2012-07-01 2012-07-01 false Cycle-validation criteria for... Over Specified Duty Cycles § 1065.514 Cycle-validation criteria for operation over specified duty...-validation criteria. You must compare the original reference duty cycle points generated as described in...

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

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 34 2013-07-01 2013-07-01 false Cycle-validation criteria for... Over Specified Duty Cycles § 1065.514 Cycle-validation criteria for operation over specified duty...-validation criteria. You must compare the original reference duty cycle points generated as described in...

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

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 33 2011-07-01 2011-07-01 false Cycle-validation criteria for... Over Specified Duty Cycles § 1065.514 Cycle-validation criteria for operation over specified duty...-validation criteria. You must compare the original reference duty cycle points generated as described in...

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

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 33 2014-07-01 2014-07-01 false Cycle-validation criteria for... Over Specified Duty Cycles § 1065.514 Cycle-validation criteria for operation over specified duty...-validation criteria. You must compare the original reference duty cycle points generated as described in...

SU-E-T-60: A Plan Quality Index in IMRT QA That Is Independent of the Acceptance Criteria

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

Kim, D; Kang, S; Kim, T

2015-06-15

Purpose: In IMRT QA, plan quality evaluation is made based on pass rate under preset acceptance criteria, mostly using gamma-values. This method is convenient but, its Result highly depends on what the acceptance criteria are and suffers from the lack of sensitivity in judging how good the plan is. In this study, we introduced a simple but effective plan quality index of IMRT QA based on dose difference only to supplement such shortcomings, and investigated its validity. Methods: The proposed index is a single value which is calculated mainly based on point-by-point comparison between planned and measured dose distributions, andmore » it becomes “1” in an ideal case. A systematic evaluation was performed with one-dimensional test dose distributions. For 3 hypothetical dose profiles, various displacements (in both dose and space) were introduced, the proposed index was calculated for each case, and the behavior of obtained indices was analyzed and compared with that of gamma evaluation. In addition, the feasibility of the index was assessed with clinical IMRT/VMAT/SBRT QA cases for different sites (prostate, head & neck, liver, lung, spine, and abdomen). Results: The proposed index showed more robust correlation with the amount of induced displacement compared to the gamma evaluation method. No matter what the acceptance criteria are (e.g., whether 3%/3mm or 2%/2mm), it was possible to clearly rank every case with the proposed index while it was difficult to do with the gamma evaluation method. Conclusion: IMRT plan quality can be evaluated quantitatively by the proposed index. It is considered that the proposed index would provide useful information for better judging the level of goodness of each plan and its Result is independent of the acceptance criteria. This work was supported by the Radiation Technology R&D program (No. 2013M2A2A7043498) and the Mid-career Researcher Program (2014R1A2A1A10050270) through the National Research Foundation of Korea funded

Prolonged Grief Disorder: Psychometric Validation of Criteria Proposed for DSM-V and ICD-11

PubMed Central

Prigerson, Holly G.; Horowitz, Mardi J.; Jacobs, Selby C.; Parkes, Colin M.; Aslan, Mihaela; Goodkin, Karl; Raphael, Beverley; Marwit, Samuel J.; Wortman, Camille; Neimeyer, Robert A.; Bonanno, George; Block, Susan D.; Kissane, David; Boelen, Paul; Maercker, Andreas; Litz, Brett T.; Johnson, Jeffrey G.; First, Michael B.; Maciejewski, Paul K.

2009-01-01

Background 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. Methods and Findings 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. Conclusions 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

How to pass a sensor acceptance test: using the gap between acceptance criteria and operational performance

NASA Astrophysics Data System (ADS)

Bijl, Piet

2016-10-01

When acquiring a new imaging system and operational task performance is a critical factor for success, it is necessary to specify minimum acceptance requirements that need to be met using a sensor performance model and/or performance tests. Currently, there exist a variety of models and test from different origin (defense, security, road safety, optometry) and they all do different predictions. This study reviews a number of frequently used methods and shows the effects that small changes in procedure or threshold criteria can have on the outcome of a test. For example, a system may meet the acceptance requirements but not satisfy the needs for the operational task, or the choice of test may determine the rank order of candidate sensors. The goal of the paper is to make people aware of the pitfalls associated with the acquisition process, by i) illustrating potential tricks to have a system accepted that is actually not suited for the operational task, and ii) providing tips to avoid this unwanted situation.

Sample acceptance time criteria, electronic issue and alloimmunisation in thalassaemia.

PubMed

Trompeter, S; Baxter, L; McBrearty, M; Zatkya, E; Porter, J

2015-12-01

To determine the safety of a 1-week acceptance criteria of sample receipt in laboratory to transfusion commencement in transfusion dependent thalassaemia with respect to alloimmunisation. To determine the safety of electronic issue of blood components in such a setting. Retrospective audit of alloimmunisation (1999-2012) and blood exposure in registered thalassaemia patients at a central London thalassaemia centre where the acceptance criteria for the group and save sample from arrival in the laboratory to the time of issue of blood for transfusion for someone who has been transfused in the last 28 days was 1 week, and there was electronic issue protocol for patients who have always had a negative antibody screen (other than temporary positivity in pregnant women receiving prophylactic anti-D or anti Le-a, Anti Le-b and Anti P1 that are no longer detectable). There were 133 patients with thalassemia variants regularly attending UCLH for review. A total of 105 patients had transfusion dependent thalassaemia (TDT) (7 E-beta thalassaemia, 98 beta thalassaemia major). Ten of the 84 patients who received their transfusions at UCLH were alloimmunised. Seven of them had been alloimmunised prior to arrival at UCLH. Only two patients developed antibodies at UCLH during this period. The prevalence of alloantibody formation of 2% in UCLH transfused patients, with presumptive incidence of 0.01 alloantibodies per 100 units or 0·001 immunisations per person per year compares favourably with other reported series and suggests that 1 week interval with appropriate electronic issue is acceptable practice. © 2015 British Blood Transfusion Society.

Implementation of the 3Rs (refinement, reduction, and replacement): validation and regulatory acceptance considerations for alternative toxicological test methods.

PubMed

Schechtman, Leonard M

2002-01-01

Toxicological testing in the current regulatory environment is steeped in a history of using animals to answer questions about the safety of products to which humans are exposed. That history forms the basis for the testing strategies that have evolved to satisfy the needs of the regulatory bodies that render decisions that affect, for the most part, virtually all phases of premarket product development and evaluation and, to a lesser extent, postmarketing surveillance. Only relatively recently have the levels of awareness of, and responsiveness to, animal welfare issues reached current proportions. That paradigm shift, although sluggish, has nevertheless been progressive. New and alternative toxicological methods for hazard evaluation and risk assessment have now been adopted and are being viewed as a means to address those issues in a manner that considers humane treatment of animals yet maintains scientific credibility and preserves the goal of ensuring human safety. To facilitate this transition, regulatory agencies and regulated industry must work together toward improved approaches. They will need assurance that the methods will be reliable and the results comparable with, or better than, those derived from the current classical methods. That confidence will be a function of the scientific validation and resultant acceptance of any given method. In the United States, to fulfill this need, the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and its operational center, the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), have been constituted as prescribed in federal law. Under this mandate, ICCVAM has developed a process and established criteria for the scientific validation and regulatory acceptance of new and alternative methods. The role of ICCVAM in the validation and acceptance process and the criteria instituted toward that end are described. Also

Definition of acceptance criteria for the ITER divertor plasma-facing components through systematic experimental analysis

NASA Astrophysics Data System (ADS)

Escourbiac, F.; Richou, M.; Guigon, R.; Constans, S.; Durocher, A.; Merola, M.; Schlosser, J.; Riccardi, B.; Grosman, A.

2009-12-01

Experience has shown that a critical part of the high-heat flux (HHF) plasma-facing component (PFC) is the armour to heat sink bond. An experimental study was performed in order to define acceptance criteria with regards to thermal hydraulics and fatigue performance of the International Thermonuclear Experimental Reactor (ITER) divertor PFCs. This study, which includes the manufacturing of samples with calibrated artificial defects relevant to the divertor design, is reported in this paper. In particular, it was concluded that defects detectable with non-destructive examination (NDE) techniques appeared to be acceptable during HHF experiments relevant to heat fluxes expected in the ITER divertor. On the basis of these results, a set of acceptance criteria was proposed and applied to the European vertical target medium-size qualification prototype: 98% of the inspected carbon fibre composite (CFC) monoblocks and 100% of tungsten (W) monoblock and flat tiles elements (i.e. 80% of the full units) were declared acceptable.

46 CFR 164.019-7 - Non-standard components; acceptance criteria and procedures.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 6 2010-10-01 2010-10-01 false Non-standard components; acceptance criteria and procedures. 164.019-7 Section 164.019-7 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED...) Outer Envelope Fabric (exterior fabrics on wearable PFDs); (ii) Cover Fabric (for throwable PFDs); (iii...

46 CFR 164.019-7 - Non-standard components; acceptance criteria and procedures.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 46 Shipping 6 2011-10-01 2011-10-01 false Non-standard components; acceptance criteria and procedures. 164.019-7 Section 164.019-7 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED...) Outer Envelope Fabric (exterior fabrics on wearable PFDs); (ii) Cover Fabric (for throwable PFDs); (iii...

48 CFR 15.607 - Criteria for acceptance and negotiation of an unsolicited proposal.

Code of Federal Regulations, 2011 CFR

2011-10-01

... and negotiation of an unsolicited proposal. 15.607 Section 15.607 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION CONTRACTING METHODS AND CONTRACT TYPES CONTRACTING BY NEGOTIATION Unsolicited Proposals 15.607 Criteria for acceptance and negotiation of an unsolicited proposal. (a) A...

48 CFR 15.607 - Criteria for acceptance and negotiation of an unsolicited proposal.

Code of Federal Regulations, 2012 CFR

2012-10-01

... and negotiation of an unsolicited proposal. 15.607 Section 15.607 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION CONTRACTING METHODS AND CONTRACT TYPES CONTRACTING BY NEGOTIATION Unsolicited Proposals 15.607 Criteria for acceptance and negotiation of an unsolicited proposal. (a) A...

48 CFR 15.607 - Criteria for acceptance and negotiation of an unsolicited proposal.

Code of Federal Regulations, 2010 CFR

2010-10-01

... and negotiation of an unsolicited proposal. 15.607 Section 15.607 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION CONTRACTING METHODS AND CONTRACT TYPES CONTRACTING BY NEGOTIATION Unsolicited Proposals 15.607 Criteria for acceptance and negotiation of an unsolicited proposal. (a) A...

48 CFR 15.607 - Criteria for acceptance and negotiation of an unsolicited proposal.

Code of Federal Regulations, 2013 CFR

2013-10-01

... and negotiation of an unsolicited proposal. 15.607 Section 15.607 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION CONTRACTING METHODS AND CONTRACT TYPES CONTRACTING BY NEGOTIATION Unsolicited Proposals 15.607 Criteria for acceptance and negotiation of an unsolicited proposal. (a) A...

48 CFR 15.607 - Criteria for acceptance and negotiation of an unsolicited proposal.

Code of Federal Regulations, 2014 CFR

2014-10-01

... and negotiation of an unsolicited proposal. 15.607 Section 15.607 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION CONTRACTING METHODS AND CONTRACT TYPES CONTRACTING BY NEGOTIATION Unsolicited Proposals 15.607 Criteria for acceptance and negotiation of an unsolicited proposal. (a) A...

48 CFR 915.607 - Criteria for acceptance and negotiation of an unsolicited proposal.

Code of Federal Regulations, 2012 CFR

2012-10-01

... and negotiation of an unsolicited proposal. 915.607 Section 915.607 Federal Acquisition Regulations System DEPARTMENT OF ENERGY CONTRACTING METHODS AND CONTRACT TYPES CONTRACTING BY NEGOTIATION Unsolicited Proposals 915.607 Criteria for acceptance and negotiation of an unsolicited proposal. (c) DOE's cost...

48 CFR 915.607 - Criteria for acceptance and negotiation of an unsolicited proposal.

Code of Federal Regulations, 2010 CFR

2010-10-01

... and negotiation of an unsolicited proposal. 915.607 Section 915.607 Federal Acquisition Regulations System DEPARTMENT OF ENERGY CONTRACTING METHODS AND CONTRACT TYPES CONTRACTING BY NEGOTIATION Unsolicited Proposals 915.607 Criteria for acceptance and negotiation of an unsolicited proposal. (c) DOE's cost...

48 CFR 915.607 - Criteria for acceptance and negotiation of an unsolicited proposal.

Code of Federal Regulations, 2013 CFR

2013-10-01

... and negotiation of an unsolicited proposal. 915.607 Section 915.607 Federal Acquisition Regulations System DEPARTMENT OF ENERGY CONTRACTING METHODS AND CONTRACT TYPES CONTRACTING BY NEGOTIATION Unsolicited Proposals 915.607 Criteria for acceptance and negotiation of an unsolicited proposal. (c) DOE's cost...

48 CFR 915.607 - Criteria for acceptance and negotiation of an unsolicited proposal.

Code of Federal Regulations, 2011 CFR

2011-10-01

... and negotiation of an unsolicited proposal. 915.607 Section 915.607 Federal Acquisition Regulations System DEPARTMENT OF ENERGY CONTRACTING METHODS AND CONTRACT TYPES CONTRACTING BY NEGOTIATION Unsolicited Proposals 915.607 Criteria for acceptance and negotiation of an unsolicited proposal. (c) DOE's cost...

48 CFR 915.607 - Criteria for acceptance and negotiation of an unsolicited proposal.

Code of Federal Regulations, 2014 CFR

2014-10-01

... and negotiation of an unsolicited proposal. 915.607 Section 915.607 Federal Acquisition Regulations System DEPARTMENT OF ENERGY CONTRACTING METHODS AND CONTRACT TYPES CONTRACTING BY NEGOTIATION Unsolicited Proposals 915.607 Criteria for acceptance and negotiation of an unsolicited proposal. (c) DOE's cost...

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

Code of Federal Regulations, 2010 CFR

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...

Ride qualities criteria validation/pilot performance study: Flight test results

NASA Technical Reports Server (NTRS)

Nardi, L. U.; Kawana, H. Y.; Greek, D. C.

1979-01-01

Pilot performance during a terrain following flight was studied for ride quality criteria validation. Data from manual and automatic terrain following operations conducted during low level penetrations were analyzed to determine the effect of ride qualities on crew performance. The conditions analyzed included varying levels of turbulence, terrain roughness, and mission duration with a ride smoothing system on and off. Limited validation of the B-1 ride quality criteria and some of the first order interactions between ride qualities and pilot/vehicle performance are highlighted. An earlier B-1 flight simulation program correlated well with the flight test results.

40 CFR 90.510 - Compliance with acceptable quality level and passing and failing criteria for selective...

Code of Federal Regulations, 2014 CFR

2014-07-01

... level and passing and failing criteria for selective enforcement audits. 90.510 Section 90.510....510 Compliance with acceptable quality level and passing and failing criteria for selective... failed engine is an engine whose final test results pursuant to § 90.509(b), for one or more of the...

40 CFR 90.510 - Compliance with acceptable quality level and passing and failing criteria for selective...

Code of Federal Regulations, 2013 CFR

2013-07-01

... level and passing and failing criteria for selective enforcement audits. 90.510 Section 90.510....510 Compliance with acceptable quality level and passing and failing criteria for selective... failed engine is an engine whose final test results pursuant to § 90.509(b), for one or more of the...

Safety analysis, risk assessment, and risk acceptance criteria

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

Jamali, K.; Stack, D.W.; Sullivan, L.H.

1997-08-01

This paper discusses a number of topics that relate safety analysis as documented in the Department of Energy (DOE) safety analysis reports (SARs), probabilistic risk assessments (PRA) as characterized primarily in the context of the techniques that have assumed some level of formality in commercial nuclear power plant applications, and risk acceptance criteria as an outgrowth of PRA applications. DOE SARs of interest are those that are prepared for DOE facilities under DOE Order 5480.23 and the implementing guidance in DOE STD-3009-94. It must be noted that the primary area of application for DOE STD-3009 is existing DOE facilities andmore » that certain modifications of the STD-3009 approach are necessary in SARs for new facilities. Moreover, it is the hazard analysis (HA) and accident analysis (AA) portions of these SARs that are relevant to the present discussions. Although PRAs can be qualitative in nature, PRA as used in this paper refers more generally to all quantitative risk assessments and their underlying methods. HA as used in this paper refers more generally to all qualitative risk assessments and their underlying methods that have been in use in hazardous facilities other than nuclear power plants. This discussion includes both quantitative and qualitative risk assessment methods. PRA has been used, improved, developed, and refined since the Reactor Safety Study (WASH-1400) was published in 1975 by the Nuclear Regulatory Commission (NRC). Much debate has ensued since WASH-1400 on exactly what the role of PRA should be in plant design, reactor licensing, `ensuring` plant and process safety, and a large number of other decisions that must be made for potentially hazardous activities. Of particular interest in this area is whether the risks quantified using PRA should be compared with numerical risk acceptance criteria (RACs) to determine whether a facility is `safe.` Use of RACs requires quantitative estimates of consequence frequency and magnitude.« less

Box-ticking and Olympic high jumping - Physicians' perceptions and acceptance of national physician validation systems.

PubMed

Sehlbach, Carolin; Govaerts, Marjan J B; Mitchell, Sharon; Rohde, Gernot G U; Smeenk, Frank W J M; Driessen, Erik W

2018-05-24

National physician validation systems aim to ensure lifelong learning through periodic appraisals of physicians' competence. Their effectiveness is determined by physicians' acceptance of and commitment to the system. This study, therefore, sought to explore physicians' perceptions and self-reported acceptance of validation across three different physician validation systems in Europe. Using a constructivist grounded-theory approach, we conducted semi-structured interviews with 32 respiratory specialists from three countries with markedly different validation systems: Germany, which has a mandatory, credit-based system oriented to continuing professional development; Denmark, with mandatory annual dialogs and ensuing, non-compulsory activities; and the UK, with a mandatory, portfolio-based revalidation system. We analyzed interview data with a view to identifying factors influencing physicians' perceptions and acceptance. Factors that influenced acceptance were the assessment's authenticity and alignment of its requirements with clinical practice, physicians' beliefs about learning, perceived autonomy, and organizational support. Users' acceptance levels determine any system's effectiveness. To support lifelong learning effectively, national physician validation systems must be carefully designed and integrated into daily practice. Involving physicians in their design may render systems more authentic and improve alignment between individual ambitions and the systems' goals, thereby promoting acceptance.

Prototypicality ratings of DSM-III criteria for personality disorders.

PubMed

Livesley, W J; Reiffer, L I; Sheldon, A E; West, M

1987-07-01

Although DSM-III personality disorder criteria have demonstrated acceptable reliability, the question of validity has not been adequately addressed. A first step in establishing the validity of diagnoses is to establish the validity of the criteria used to assess each diagnosis. The content validity of diagnostic criteria was investigated in relation to the larger set of potential criteria culled from the psychiatric literature. For each DSM-III axis II diagnosis, a panel of clinicians rated how prototypical each potential criterion was of the diagnosis in question. The results reveal problems with the organization and content of the criteria for most diagnoses. Many DSM-III criteria are composed of several statements linked by conjunctions or disjunctions. These component statements often received markedly different ratings, suggesting that criteria should be single statements. For most diagnoses, traits not included in DSM-III received higher ratings than did some DSM-III criteria. Suggestions are made to improve the distinctiveness and content validity of paranoid, schizoid, antisocial, borderline, avoidant, dependent, and compulsive personality disorders. The results for schizotypal personality disorder suggest that many clinicians are uncertain about this diagnosis. These findings provide a systematic way to modify definitions that contrasts with the more arbitrary ways in which diagnoses have previously been defined and redefined.

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

PubMed Central

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

40 CFR 86.610-98 - Compliance with acceptable quality level and passing and failing criteria for Selective...

Code of Federal Regulations, 2012 CFR

2012-07-01

... level and passing and failing criteria for Selective Enforcement Audits. 86.610-98 Section 86.610-98... quality level and passing and failing criteria for Selective Enforcement Audits. (a) The prescribed acceptable quality level is 40 percent. (b) A failed vehicle is one whose final deteriorated test results...

40 CFR 86.610-98 - Compliance with acceptable quality level and passing and failing criteria for Selective...

Code of Federal Regulations, 2010 CFR

2010-07-01

... level and passing and failing criteria for Selective Enforcement Audits. 86.610-98 Section 86.610-98... quality level and passing and failing criteria for Selective Enforcement Audits. (a) The prescribed acceptable quality level is 40 percent. (b) A failed vehicle is one whose final deteriorated test results...

40 CFR 86.610-98 - Compliance with acceptable quality level and passing and failing criteria for Selective...

Code of Federal Regulations, 2011 CFR

2011-07-01

... level and passing and failing criteria for Selective Enforcement Audits. 86.610-98 Section 86.610-98... quality level and passing and failing criteria for Selective Enforcement Audits. (a) The prescribed acceptable quality level is 40 percent. (b) A failed vehicle is one whose final deteriorated test results...

40 CFR 86.610-98 - Compliance with acceptable quality level and passing and failing criteria for Selective...

Code of Federal Regulations, 2014 CFR

2014-07-01

... level and passing and failing criteria for Selective Enforcement Audits. 86.610-98 Section 86.610-98... and passing and failing criteria for Selective Enforcement Audits. (a) The prescribed acceptable quality level is 40 percent. (b) A failed vehicle is one whose final deteriorated test results pursuant to...

40 CFR 86.610-98 - Compliance with acceptable quality level and passing and failing criteria for Selective...

Code of Federal Regulations, 2013 CFR

2013-07-01

... level and passing and failing criteria for Selective Enforcement Audits. 86.610-98 Section 86.610-98... quality level and passing and failing criteria for Selective Enforcement Audits. (a) The prescribed acceptable quality level is 40 percent. (b) A failed vehicle is one whose final deteriorated test results...

How valid are current diagnostic criteria for dental erosion?

PubMed Central

2008-01-01

In principle, there is agreement about the clinical diagnostic criteria for dental erosion, basically defined as cupping and grooving of the occlusal/incisal surfaces, shallow defects on smooth surfaces located coronal from the enamel–cementum junction with an intact cervical enamel rim and restorations rising above the adjacent tooth surface. This lesion characteristic was established from clinical experience and from observations in a small group of subjects with known exposure to acids rather than from systematic research. Their prevalence is higher in risk groups for dental erosion compared to subjects not particularly exposed to acids, but analytical epidemiological studies on random or cluster samples often fail to find a relation between occurrence or severity of lesions and any aetiological factor. Besides other aspects, this finding might be due to lack of validity with respect to diagnostic criteria. In particular, cupping and grooving might be an effect of abrasion as well as of erosion and their value for the specific diagnosis of erosion must be doubted. Knowledge about the validity of current diagnostic criteria of different forms of tooth wear is incomplete, therefore further research is needed. PMID:18228062

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

PubMed

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.

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

PubMed

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.

78 FR 65007 - Inspections, Tests, Analyses, and Acceptance Criteria; Vogtle Electric Generating Plant, Unit 3

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-30

... NUCLEAR REGULATORY COMMISSION [Docket No. 052-00026; NRC-2008-0252] Inspections, Tests, Analyses... Commission. ACTION: Determination of inspections, tests, analyses, and acceptance criteria completion. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) staff has determined that the inspections, tests...

78 FR 53484 - Inspections, Tests, Analyses, and Acceptance Criteria; Vogtle Electric Generating Plant, Unit 4

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-29

... NUCLEAR REGULATORY COMMISSION [Docket No. 052-00026; NRC-2008-0252] Inspections, Tests, Analyses... Commission. ACTION: Determination of inspections, tests, analyses, and acceptance criteria (ITAAC) completion. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) staff has determined that the inspections, tests...

78 FR 53483 - Inspections, Tests, Analyses, and Acceptance Criteria; Vogtle Electric Generating Plant, Unit 3

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-29

... NUCLEAR REGULATORY COMMISSION [Docket No. 052-00025; NRC-2008-0252] Inspections, Tests, Analyses... Commission. ACTION: Determination of inspections, tests, analyses, and acceptance criteria (ITAAC) completion. SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) staff has determined that the inspections, tests...

A systematic review of the Diagnostic and Statistical Manual diagnostic criteria for nicotine dependence.

PubMed

DiFranza, Joseph; Ursprung, W W Sanouri; Lauzon, Béatrice; Bancej, Christina; Wellman, Robert J; Ziedonis, Douglas; Kim, Sun S; Gervais, André; Meltzer, Bruce; McKay, Colleen E; O'Loughlin, Jennifer; Okoli, Chizimuzo T C; Fortuna, Lisa R; Tremblay, Michèle

2010-05-01

The Diagnostic and Statistical Manual diagnostic criteria for nicotine dependence (DSM-ND) are based on the proposition that dependence is a syndrome that can be diagnosed only when a minimum of 3 of the 7 proscribed features are present. The DSM-ND criteria are an accepted research measure, but the validity of these criteria has not been subjected to a systematic evaluation. To systematically review evidence of validity and reliability for the DSM-ND criteria, a literature search was conducted of 16 national and international databases. Each article with original data was independently reviewed by two or more reviewers. In total, 380 potentially relevant articles were examined and 169 were reviewed in depth. The DSM-ND criteria have seen wide use in research settings, but sensitivity and specificity are well below the accepted standards for clinical applications. Predictive validity is generally poor. The 7 DSM-ND criteria are regarded as having face validity, but no data support a 3-symptom ND diagnostic threshold, or a 4-symptom withdrawal syndrome threshold. The DSM incorrectly states that daily smoking is a prerequisite for withdrawal symptoms. The DSM shows poor to modest concurrence with all other measures of nicotine dependence, smoking behaviors and biological measures of tobacco use. The data support the DSM-ND criteria as a valid measure of nicotine dependence severity for research applications. However, the data do not support the central premise of a 3-symptom diagnostic threshold, and no data establish that the DSM-ND criteria provide an accurate diagnosis of nicotine dependence. Copyright (c) 2009 Elsevier Ltd. All rights reserved.

Validation of prescribing appropriateness criteria for older Australians using the RAND/UCLA appropriateness method

PubMed Central

Basger, Benjamin Joseph; Chen, Timothy Frank; Moles, Rebekah Jane

2012-01-01

Objective To further develop and validate previously published national prescribing appropriateness criteria to assist in identifying drug-related problems (DRPs) for commonly occurring medications and medical conditions in older (≥65 years old) Australians. Design RAND/UCLA appropriateness method. Participants A panel of medication management experts were identified consisting of geriatricians/pharmacologists, clinical pharmacists and disease management advisors to organisations that produce Australian evidence-based therapeutic publications. This resulted in a round-one panel of 15 members, and a round-two panel of 12 members. Main outcome measure Agreement on all criteria. Results Forty-eight prescribing criteria were rated. In the first rating round via email, there was disagreement regarding 17 of the criteria according to median panel ratings. During a face-to-face second round meeting, discussion resulted in retention of 25 criteria after amendments, agreement for 14 criteria with no changes required and deletion of 9 criteria. Two new criteria were added, resulting in a final validated list of 41 prescribing appropriateness criteria. Agreement after round two was reached for all 41 criteria, measured by median panel ratings and the amount of dispersion of panel ratings, based on the interpercentile range. Conclusions A set of 41 Australian prescribing appropriateness criteria were validated by an expert panel. Use of these criteria, together with clinical judgement and other medication review processes such as patient interview, is intended to assist in improving patient care by efficiently detecting potential DRPs related to commonly occurring medicines and medical conditions in older Australians. These criteria may also contribute to the medication management education of healthcare professionals. PMID:22983875

21 CFR 212.70 - What controls and acceptance criteria must I have for my finished PET drug products?

Code of Federal Regulations, 2010 CFR

2010-04-01

... for my finished PET drug products? 212.70 Section 212.70 Food and Drugs FOOD AND DRUG ADMINISTRATION... What controls and acceptance criteria must I have for my finished PET drug products? (a) Specifications. You must establish specifications for each PET drug product, including criteria for determining...

Parents' "Hard" Knowledge of Admission Criteria and Acceptance in Philadelphia's High School Choice Process

ERIC Educational Resources Information Center

Haxton, Clarisse L.; Neild, Ruth Curran

2012-01-01

We examine parents' knowledge of discrete, verifiable facts--what we call "hard knowledge"--in a high school application process. Using parent survey data (n = 658) from the School District of Philadelphia, this study examines whether parents knew the admission criteria and acceptance rate at the high school they most wanted their child…

21 CFR 212.70 - What controls and acceptance criteria must I have for my finished PET drug products?

Code of Federal Regulations, 2011 CFR

2011-04-01

... for my finished PET drug products? 212.70 Section 212.70 Food and Drugs FOOD AND DRUG ADMINISTRATION... acceptance criteria must I have for my finished PET drug products? (a) Specifications. You must establish specifications for each PET drug product, including criteria for determining identity, strength, quality, purity...

21 CFR 212.70 - What controls and acceptance criteria must I have for my finished PET drug products?

Code of Federal Regulations, 2013 CFR

2013-04-01

... for my finished PET drug products? 212.70 Section 212.70 Food and Drugs FOOD AND DRUG ADMINISTRATION... acceptance criteria must I have for my finished PET drug products? (a) Specifications. You must establish specifications for each PET drug product, including criteria for determining identity, strength, quality, purity...

21 CFR 212.70 - What controls and acceptance criteria must I have for my finished PET drug products?

Code of Federal Regulations, 2014 CFR

2014-04-01

... for my finished PET drug products? 212.70 Section 212.70 Food and Drugs FOOD AND DRUG ADMINISTRATION... acceptance criteria must I have for my finished PET drug products? (a) Specifications. You must establish specifications for each PET drug product, including criteria for determining identity, strength, quality, purity...

21 CFR 212.70 - What controls and acceptance criteria must I have for my finished PET drug products?

Code of Federal Regulations, 2012 CFR

2012-04-01

... for my finished PET drug products? 212.70 Section 212.70 Food and Drugs FOOD AND DRUG ADMINISTRATION... acceptance criteria must I have for my finished PET drug products? (a) Specifications. You must establish specifications for each PET drug product, including criteria for determining identity, strength, quality, purity...

Validity criteria for Fermi's golden rule scattering rates applied to metallic nanowires.

PubMed

Moors, Kristof; Sorée, Bart; Magnus, Wim

2016-09-14

Fermi's golden rule underpins the investigation of mobile carriers propagating through various solids, being a standard tool to calculate their scattering rates. As such, it provides a perturbative estimate under the implicit assumption that the effect of the interaction Hamiltonian which causes the scattering events is sufficiently small. To check the validity of this assumption, we present a general framework to derive simple validity criteria in order to assess whether the scattering rates can be trusted for the system under consideration, given its statistical properties such as average size, electron density, impurity density et cetera. We derive concrete validity criteria for metallic nanowires with conduction electrons populating a single parabolic band subjected to different elastic scattering mechanisms: impurities, grain boundaries and surface roughness.

Expanded criteria donor kidneys for younger recipients: acceptable outcomes.

PubMed

Goplani, K R; Kute, V B; Vanikar, A V; Shah, P R; Gumber, M R; Patel, H V; Modi, P R; Trivedi, H L

2010-12-01

European senior programme (ESP) is well known for acceptable outcomes using expanded criteria donor (ECD) kidneys from donors older than 65 years for recipients older than 65 years. The incidence of end-stage renal disease (ESRD) is 229/million in India with a mean age of 45 years. We performed a retrospective analysis of transplantation of ECD versus standard criteria donor (SCD) kidneys into younger recipients. Forty-three ECD transplantations among 158 deceased donor organ transplantation (DDOT) were performed between January 2006 and December 2009. Among 43 transplantation from 30 donors, 14 were dual kidney transplantations (DKT) performed based upon biopsy evaluation. All recipients received thymoglobulin (rATG) induction followed by immunosuppression with a steroid, mycophenolate mofetil (MMF), and a calcineurin inhibitor. Statistical analysis used chi-square test and unpaired Student t test. Kaplan-Meier curves were used for survival analysis. For ECD the mean donor age was 64 ± 11 years. Cerebrovascular accidents (CVA) were the cause of death among 60% of donors, 73.13% of whom were hypertensive and 23.13% diabetic. Mean DKT donor age was 75 ± 9.17 years versus 60 ± 8.0 years for single kidney transplantation (SKT). Mean recipient age of DKT versus SKT was 44 ± 12.4 years versus 43 ± 14 years. Mean serum creatinine (SCr; mg/dL) of SKT patients was 1.64 ± 0.75 versus 1.68 ± 0.46 in DKT. Mean follow-up was 455 ± 352 days. Mean SCr of 43 ECD recipients of mean age, 43.4 ± 14.2 years was 1.61 ± 0.61 mg/dL. Among 43 recipients, 23.25% were diabetic, 41.86% displayed delayed graft function (DGF), and 23.25% experienced biopsy-proven acute rejection (BPAR). Patient survival rate was 72.09% and graft survival rate was 67.44%. For SCD transplantations (n = 115), the mean donor age was 36 ± 14 years and recipient mean age was 32.8 ± 14.07 years. Mean SCr was 1.32 ± 0.46 mg/dL with 26.95% recipients displaying DGF, whereas 20.86% had BPAR. In the SCD

Nonclinical dose formulation analysis method validation and sample analysis.

PubMed

Whitmire, Monica Lee; Bryan, Peter; Henry, Teresa R; Holbrook, John; Lehmann, Paul; Mollitor, Thomas; Ohorodnik, Susan; Reed, David; Wietgrefe, Holly D

2010-12-01

Nonclinical dose formulation analysis methods are used to confirm test article concentration and homogeneity in formulations and determine formulation stability in support of regulated nonclinical studies. There is currently no regulatory guidance for nonclinical dose formulation analysis method validation or sample analysis. Regulatory guidance for the validation of analytical procedures has been developed for drug product/formulation testing; however, verification of the formulation concentrations falls under the framework of GLP regulations (not GMP). The only current related regulatory guidance is the bioanalytical guidance for method validation. The fundamental parameters for bioanalysis and formulation analysis validations that overlap include: recovery, accuracy, precision, specificity, selectivity, carryover, sensitivity, and stability. Divergence in bioanalytical and drug product validations typically center around the acceptance criteria used. As the dose formulation samples are not true "unknowns", the concept of quality control samples that cover the entire range of the standard curve serving as the indication for the confidence in the data generated from the "unknown" study samples may not always be necessary. Also, the standard bioanalytical acceptance criteria may not be directly applicable, especially when the determined concentration does not match the target concentration. This paper attempts to reconcile the different practices being performed in the community and to provide recommendations of best practices and proposed acceptance criteria for nonclinical dose formulation method validation and sample analysis.

La composition academique: les limites de l'acceptabilite (Composition for Academic Purposes: Criteria for Acceptability).

ERIC Educational Resources Information Center

Grenall, G. M.

1981-01-01

Examines the pedagogical approaches and problems attendant to the development of English writing programs for foreign students. Discusses the skills necessary to handle course work, such as essay tests, term papers and reports, theses and dissertations, and focuses particularly on diagnostic problems and acceptability criteria. Societe Nouvelle…

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

ERIC Educational Resources Information Center

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 Chronic Pain Acceptance Questionnaire (CPAQ) in Cantonese-speaking Chinese patients.

PubMed

Cheung, Michelle N; Ning, Michelle Cheung; Wong, Tony C M; Ming, Tony Wong Chi; Yap, Jacqueline C M; Mae, Jacqueline Yap Chooi; Chen, Phoon P; Ping, Chen Phoon

2008-09-01

Acceptance of chronic pain has become an important concept in understanding and predicting that chronic pain sufferers can remain engaged with meaningful aspects of life. Assessment of acceptance has been facilitated by the development of Chronic Pain Acceptance Questionnaire (CPAQ). In this study, we aimed to test the reliability and validity of translated Chinese version of CPAQ to use this important tool in the future management of Hong Kong Chinese patients with chronic nonmalignant pain. Content validity was established by consensus formed among a panel of 5 experts in clinical psychology and pain specialty during the process of forward and backward translations. Test-retest reliability was examined by completing the Chinese CPAQ twice, 2 weeks apart, by 54 patients. A total of 224 Chinese patients with chronic nonmalignant pain attending our cluster multidisciplinary pain clinic were asked to complete a battery of psychometric instruments in Chinese, including an intake form for demographic data, Hospital Anxiety and Depression Score (HADS), Medical Outcome Study Short Form 36 (SF-36), Pain Catastrophizing Scale (PCS), and Pain Self-Efficacy Questionnaire (PSEQ). Analysis results showed that Chinese CPAQ had good test-retest reliability (intraclass correlation coefficient, 0.79) and internal consistency reliability (Cronbach alpha = 0.79). The Chinese CPAQ score was significantly correlated to anxiety, depression, pain catastrophizing, pain self-efficacy, and physical and psychosocial disability. Scree plot and Principal Components Factor analysis confirmed the same 2-factor construct as the original English CPAQ. Construct validity of the Chinese CPAQ can therefore be supported. In conclusion, the Chinese CPAQ is a reliable clinical assessment tool with valid construct for acceptance measurement in our heterogeneous Chinese patients sample with chronic nonmalignant pain. This article confirms the reliability and validity of a Chinese version of the CPAQ. The

Validating e-learning in continuing pharmacy education: user acceptance and knowledge change

PubMed Central

2014-01-01

Background Continuing pharmacy education is becoming mandatory in most countries in order to keep the professional license valid. Increasing number of pharmacists are now using e-learning as part of their continuing education. Consequently, the increasing popularity of this method of education calls for standardization and validation practices. The conducted research explored validation aspects of e-learning in terms of knowledge increase and user acceptance. Methods Two e-courses were conducted as e-based continuing pharmacy education for graduated pharmacists. Knowledge increase and user acceptance were the two outcome measured. The change of knowledge in the first e-course was measured by a pre- and post-test and results analysed by the Wilcoxon signed–rank test. The acceptance of e-learning in the second e-course was investigated by a questionnaire and the results analysed using descriptive statistics. Results Results showed that knowledge increased significantly (p < 0.001) by 16 pp after participation in the first e-course. Among the participants who responded to the survey in the second course, 92% stated that e-courses were effective and 91% stated that they enjoyed the course. Conclusions The study shows that e-learning is a viable medium of conducting continuing pharmacy education; e-learning is effective in increasing knowledge and highly accepted by pharmacists from various working environments such as community and hospital pharmacies, faculties of pharmacy or wholesales. PMID:24528547

Validation of Proposed DSM-5 Criteria for Autism Spectrum Disorder

PubMed Central

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

2011-01-01

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; 5,863 non-ASD) included in a national registry, the Interactive Autism Network. Youth aged 2–18 were included if at least one child in the family was diagnosed with ASD. Caregivers reported symptoms using the Social Responsiveness Scale and the Social Communication Questionnaire. The structure of autism symptoms was examined using latent variable models that included categories, dimensions, or hybrid models specifying categories and sub-dimensions. Diagnostic efficiency statistics evaluated the proposed DSM-5 algorithm in identifying ASD. Results A hybrid model that included both a category (ASD vs. non-ASD) and two symptom dimensions (social communication/interaction and restricted/repetitive behaviors) was more parsimonious than all other models and replicated across measures and sub-samples. Empirical classifications from this hybrid model closely mirrored clinical ASD diagnoses (90% overlap), implying a broad ASD category distinct from non-ASD. DSM-5 criteria had superior specificity relative to DSM-IV-TR criteria (.97 vs. .86), however sensitivity was lower (.81 vs. .95). Relaxing DSM-5 criteria by requiring one less symptom criterion increased sensitivity (.93 vs. .81), with minimal reduction in specificity (.95 vs. .97). Conclusions Results supported the validity of proposed DSM-5 criteria for ASD as provided in Phase I field trials criteria. Increased specificity of DSM-5 relative to DSM-IV-TR may reduce false positive diagnoses, a particularly relevant consideration for low base rate clinical settings. Phase II testing of DSM-5 should consider a relaxed algorithm, without which as many as 12% of ASD-affected individuals, particularly females, will be missed. Relaxed DSM-5 criteria may improve identification of ASD, decreasing societal costs through

Criteria of validity for animal models of psychiatric disorders: focus on anxiety disorders and depression

PubMed Central

2011-01-01

Animal models of psychiatric disorders are usually discussed with regard to three criteria first elaborated by Willner; face, predictive and construct validity. Here, we draw the history of these concepts and then try to redraw and refine these criteria, using the framework of the diathesis model of depression that has been proposed by several authors. We thus propose a set of five major criteria (with sub-categories for some of them); homological validity (including species validity and strain validity), pathogenic validity (including ontopathogenic validity and triggering validity), mechanistic validity, face validity (including ethological and biomarker validity) and predictive validity (including induction and remission validity). Homological validity requires that an adequate species and strain be chosen: considering species validity, primates will be considered to have a higher score than drosophila, and considering strains, a high stress reactivity in a strain scores higher than a low stress reactivity in another strain. Pathological validity corresponds to the fact that, in order to shape pathological characteristics, the organism has been manipulated both during the developmental period (for example, maternal separation: ontopathogenic validity) and during adulthood (for example, stress: triggering validity). Mechanistic validity corresponds to the fact that the cognitive (for example, cognitive bias) or biological mechanisms (such as dysfunction of the hormonal stress axis regulation) underlying the disorder are identical in both humans and animals. Face validity corresponds to the observable behavioral (ethological validity) or biological (biomarker validity) outcomes: for example anhedonic behavior (ethological validity) or elevated corticosterone (biomarker validity). Finally, predictive validity corresponds to the identity of the relationship between the triggering factor and the outcome (induction validity) and between the effects of the treatments

Validation of the French version of the Acceptability E-scale (AES) for mental E-health systems.

PubMed

Micoulaud-Franchi, Jean-Arthur; Sauteraud, Alain; Olive, Jérôme; Sagaspe, Patricia; Bioulac, Stéphanie; Philip, Pierre

2016-03-30

Despite the increasing use of E-health systems for mental-health organizations, there is a lack of psychometric tools to evaluate their acceptability by patients with mental disorders. Thus, this study aimed to translate and validate a French version of the Acceptability E-scale (AES), a 6-item self-reported questionnaire that evaluates the extent to which patients find E-health systems acceptable. A forward-backward translation of the AES was performed. The psychometric properties of the French AES version, with construct validity, internal structural validity and external validity (Pearson's coefficient between AES scores and depression symptoms on the Beck Depression Inventory II) were analyzed. In a sample of 178 patients (mean age=46.51 years, SD=12.91 years), the validation process revealed satisfactory psychometric properties: factor analysis revealed two factors: "Satisfaction" (3 items) and "Usability" (3 items) and Cronbach's alpha was 0.7. No significant relation was found between AES scores and depression symptoms. The French version of the AES revealed a two-factor scale that differs from the original version. In line with the importance of acceptability in mental health and with a view to E-health systems for patients with mental disorders, the use of the AES in psychiatry may provide important information on acceptability (i.e., satisfaction and usability). Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Preliminary Mark-18A (Mk-18A) Target Material Recovery Program Product Acceptance Criteria

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

Robinson, Sharon M.; Patton, Bradley D.

2016-09-01

The Mk-18A Target Material Recovery Program (MTMRP) was established in 2015 to preserve the unique materials, e.g. 244Pu, in 65 previously irradiated Mk-18A targets for future use. This program utilizes existing capabilities at SRS and Savannah River National Laboratory (SRNL) to process targets, recover materials from them, and to package the recovered materials for shipping to ORNL. It also utilizes existing capabilities at ORNL to receive and store the recovered materials, and to provide any additional processing of the recovered materials or residuals required to prepare them for future beneficial use. The MTMRP is presently preparing for the processing ofmore » these valuable targets which is expected to begin in ~2019. As part of the preparations for operations, this report documents the preliminary acceptance criteria for the plutonium and heavy curium materials to be recovered from the Mk-18A targets at SRNL for transport and storage at ORNL. These acceptance criteria were developed based on preliminary concepts developed for processing, transporting, and storing the recovered Mk-18A materials. They will need to be refined as these concepts are developed in more detail.« less

Validity criteria for Fermi’s golden rule scattering rates applied to metallic nanowires

NASA Astrophysics Data System (ADS)

Moors, Kristof; Sorée, Bart; Magnus, Wim

2016-09-01

Fermi’s golden rule underpins the investigation of mobile carriers propagating through various solids, being a standard tool to calculate their scattering rates. As such, it provides a perturbative estimate under the implicit assumption that the effect of the interaction Hamiltonian which causes the scattering events is sufficiently small. To check the validity of this assumption, we present a general framework to derive simple validity criteria in order to assess whether the scattering rates can be trusted for the system under consideration, given its statistical properties such as average size, electron density, impurity density et cetera. We derive concrete validity criteria for metallic nanowires with conduction electrons populating a single parabolic band subjected to different elastic scattering mechanisms: impurities, grain boundaries and surface roughness.

The Development and Validation of the Measure of Acceptance of the Theory of Evolution Instrument.

ERIC Educational Resources Information Center

Rutledge, Michael L.; Warden, Melissa A.

1999-01-01

Describes the development and validation of the Measure of Acceptance of the Theory of Evolution (MATE), a 20-item, Likert-scaled instrument that assesses teachers' overall acceptance of evolutionary theory. (Author/CCM)

Educational Technology Acceptance across Cultures: A Validation of the Unified Theory of Acceptance and Use of Technology in the Context of Turkish National Culture

ERIC Educational Resources Information Center

Gogus, Aytac; Nistor, Nicolae; Riley, Richard W.; Lerche, Thomas

2012-01-01

The Unified Theory of Acceptance and Use of Technology (UTAUT; Venkatesh et al., 2003, 2012) proposes a major model of educational technology acceptance (ETA) which has been yet validated only in few languages and cultures. Therefore, this study aims at extending the applicability of UTAUT to Turkish culture. Based on acceptance and cultural data…

40 CFR 89.510 - Compliance with acceptable quality level and passing and failing criteria for selective...

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 20 2011-07-01 2011-07-01 false Compliance with acceptable quality level and passing and failing criteria for selective enforcement audits. 89.510 Section 89.510... EMISSIONS FROM NEW AND IN-USE NONROAD COMPRESSION-IGNITION ENGINES Selective Enforcement Auditing § 89.510...

Common Criteria Evaluation and Validation Scheme for Information Technology Security: Guidance to Validators of IT Security Evaluations

DTIC Science & Technology

2002-02-01

NVLAP procedures are compatible with, among others, the most recent official publications of ISO / IEC 17025 (formally ISO / IEC Guide 25), ISO Guides 2, 30... IEC Guide 17025 and the relevant requirements of ISO 9002-1994. NVLAP Handbook 150-20 contains information that is specific to Common Criteria...Evaluation Technical Report EAP Evaluation Acceptance Package IEC International Electrotechnical Commission ISO International

Objective criteria for acceptability and constancy tests of digital subtraction angiography.

PubMed

de las Heras, Hugo; Torres, Ricardo; Fernández-Soto, José Miguel; Vañó, Eliseo

2016-01-01

Demonstrate an objective procedure to quantify image quality in digital subtraction angiography (DSA) and suggest thresholds for acceptability and constancy tests. Series of images were obtained in a DSA system simulating a small (paediatric) and a large patient using the dynamic phantom described in the IEC and DIN standards for acceptance tests of DSA equipment. Image quality was quantified using measurements of contrast-to-noise ratio (CNR). Overall scores combining the CNR of 10-100 mg/ml Iodine at a vascular diameter of 1-4 mm in a homogeneous background were defined. Phantom entrance surface air kerma (Ka,e) was measured with an ionisation chamber. The visibility of a low-contrast vessel in DSA images has been identified with a CNR value of 0.50 ± 0.03. Despite using 14 times more Ka,e (8.85 vs 0.63 mGy/image), the protocol for large patients showed a decrease in the overall score CNRsum of 67% (4.21 ± 0.06 vs 2.10 ± 0.05). The uncertainty in the results of the objective method was below 5%. Objective evaluation of DSA images using CNR is feasible with dedicated phantom measurements. An objective methodology has been suggested for acceptance tests compliant with the IEC/DIN standards. The defined overall scores can serve to fix a reproducible baseline for constancy tests, as well as to study the device stability within one acquisition series and compare different imaging protocols. This work provides aspects that have not been included in the recent European guidelines on Criteria for Acceptability of Medical Radiological Equipment. Copyright © 2015 Associazione Italiana di Fisica Medica. Published by Elsevier Ltd. All rights reserved.

Data Acceptance Criteria for Standardized Human-Associated Fecal Source Identification Quantitative Real-Time PCR Methods.

PubMed

Shanks, Orin C; Kelty, Catherine A; Oshiro, Robin; Haugland, Richard A; Madi, Tania; Brooks, Lauren; Field, Katharine G; Sivaganesan, Mano

2016-05-01

There is growing interest in the application of human-associated fecal source identification quantitative real-time PCR (qPCR) technologies for water quality management. The transition from a research tool to a standardized protocol requires a high degree of confidence in data quality across laboratories. Data quality is typically determined through a series of specifications that ensure good experimental practice and the absence of bias in the results due to DNA isolation and amplification interferences. However, there is currently a lack of consensus on how best to evaluate and interpret human fecal source identification qPCR experiments. This is, in part, due to the lack of standardized protocols and information on interlaboratory variability under conditions for data acceptance. The aim of this study is to provide users and reviewers with a complete series of conditions for data acceptance derived from a multiple laboratory data set using standardized procedures. To establish these benchmarks, data from HF183/BacR287 and HumM2 human-associated qPCR methods were generated across 14 laboratories. Each laboratory followed a standardized protocol utilizing the same lot of reference DNA materials, DNA isolation kits, amplification reagents, and test samples to generate comparable data. After removal of outliers, a nested analysis of variance (ANOVA) was used to establish proficiency metrics that include lab-to-lab, replicate testing within a lab, and random error for amplification inhibition and sample processing controls. Other data acceptance measurements included extraneous DNA contamination assessments (no-template and extraction blank controls) and calibration model performance (correlation coefficient, amplification efficiency, and lower limit of quantification). To demonstrate the implementation of the proposed standardized protocols and data acceptance criteria, comparable data from two additional laboratories were reviewed. The data acceptance criteria

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

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

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 approachesmore » 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.« less

Validation of a multi-criteria evaluation model for animal welfare.

PubMed

Martín, P; Czycholl, I; Buxadé, C; Krieter, J

2017-04-01

The aim of this paper was to validate an alternative multi-criteria evaluation system to assess animal welfare on farms based on the Welfare Quality® (WQ) project, using an example of welfare assessment of growing pigs. This alternative methodology aimed to be more transparent for stakeholders and more flexible than the methodology proposed by WQ. The WQ assessment protocol for growing pigs was implemented to collect data in different farms in Schleswig-Holstein, Germany. In total, 44 observations were carried out. The aggregation system proposed in the WQ protocol follows a three-step aggregation process. Measures are aggregated into criteria, criteria into principles and principles into an overall assessment. This study focussed on the first two steps of the aggregation. Multi-attribute utility theory (MAUT) was used to produce a value of welfare for each criterion and principle. The utility functions and the aggregation function were constructed in two separated steps. The MACBETH (Measuring Attractiveness by a Categorical-Based Evaluation Technique) method was used for utility function determination and the Choquet integral (CI) was used as an aggregation operator. The WQ decision-makers' preferences were fitted in order to construct the utility functions and to determine the CI parameters. The validation of the MAUT model was divided into two steps, first, the results of the model were compared with the results of the WQ project at criteria and principle level, and second, a sensitivity analysis of our model was carried out to demonstrate the relative importance of welfare measures in the different steps of the multi-criteria aggregation process. Using the MAUT, similar results were obtained to those obtained when applying the WQ protocol aggregation methods, both at criteria and principle level. Thus, this model could be implemented to produce an overall assessment of animal welfare in the context of the WQ protocol for growing pigs. Furthermore, this

Proposed GTA welding specification and acceptance criteria for the MC4163

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

Kwiatkowski, J.J.

1991-04-12

This specification documents the gas tungsten arc (GTA) welding process and production weld acceptance criteria requirements for the MC4163. This document is written specifically to apply to the welds on the MC4163 and is not to be used as a general gas tungsten arc welding specification. All sections of this specification must be complied with unless specifically exempted in writing. There are a total of five welds with three different joint designs required to fabricate the MC4163. In the order of fabrication they are (1) initiator closure disc, (2) nozzle to case girth welds, two and, (3) nozzle closure discmore » welds, two. This specification will only address the nozzle to case girth welds and the nozzle closure disc welds.« less

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

ERIC Educational Resources Information Center

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…

Periodic benefit-risk assessment using Bayesian stochastic multi-criteria acceptability analysis

PubMed Central

Li, Kan; Yuan, Shuai Sammy; Wang, William; Wan, Shuyan Sabrina; Ceesay, Paulette; Heyse, Joseph F.; Mt-Isa, Shahrul; Luo, Sheng

2018-01-01

Benefit-risk (BR) assessment is essential to ensure the best decisions are made for a medical product in the clinical development process, regulatory marketing authorization, post-market surveillance, and coverage and reimbursement decisions. One challenge of BR assessment in practice is that the benefit and risk profile may keep evolving while new evidence is accumulating. Regulators and the International Conference on Harmonization (ICH) recommend performing periodic benefit-risk evaluation report (PBRER) through the product's lifecycle. In this paper, we propose a general statistical framework for periodic benefit-risk assessment, in which Bayesian meta-analysis and stochastic multi-criteria acceptability analysis (SMAA) will be combined to synthesize the accumulating evidence. The proposed approach allows us to compare the acceptability of different drugs dynamically and effectively and accounts for the uncertainty of clinical measurements and imprecise or incomplete preference information of decision makers. We apply our approaches to two real examples in a post-hoc way for illustration purpose. The proposed method may easily be modified for other pre and post market settings, and thus be an important complement to the current structured benefit-risk assessment (sBRA) framework to improve the transparent and consistency of the decision-making process. PMID:29505866

Periodic benefit-risk assessment using Bayesian stochastic multi-criteria acceptability analysis.

PubMed

Li, Kan; Yuan, Shuai Sammy; Wang, William; Wan, Shuyan Sabrina; Ceesay, Paulette; Heyse, Joseph F; Mt-Isa, Shahrul; Luo, Sheng

2018-04-01

Benefit-risk (BR) assessment is essential to ensure the best decisions are made for a medical product in the clinical development process, regulatory marketing authorization, post-market surveillance, and coverage and reimbursement decisions. One challenge of BR assessment in practice is that the benefit and risk profile may keep evolving while new evidence is accumulating. Regulators and the International Conference on Harmonization (ICH) recommend performing periodic benefit-risk evaluation report (PBRER) through the product's lifecycle. In this paper, we propose a general statistical framework for periodic benefit-risk assessment, in which Bayesian meta-analysis and stochastic multi-criteria acceptability analysis (SMAA) will be combined to synthesize the accumulating evidence. The proposed approach allows us to compare the acceptability of different drugs dynamically and effectively and accounts for the uncertainty of clinical measurements and imprecise or incomplete preference information of decision makers. We apply our approaches to two real examples in a post-hoc way for illustration purpose. The proposed method may easily be modified for other pre and post market settings, and thus be an important complement to the current structured benefit-risk assessment (sBRA) framework to improve the transparent and consistency of the decision-making process. Copyright © 2018 Elsevier Inc. All rights reserved.

Validity of the Associated Symptom Criteria for Generalized Anxiety Disorder: Observations From the Singapore Mental Health Study.

PubMed

Lee, Siau Pheng; Ong, Clarissa; Vaingankar, Janhavi Ajit; Chong, Siow Ann; Subramaniam, Mythily

2017-05-01

Previous findings on the diagnostic validity and reliability of generalized anxiety disorder (GAD)-associated symptom criteria suggest need for further evaluation. The current study examined convergent validity and specificity of GAD-associated symptoms in a representative Singapore community sample. The Singapore of Mental Health Study a cross-sectional epidemiological survey conducted among 6166 Singapore residents aged 18 and older. The Composite International Diagnostic Interview version 3.0 was used to diagnose mental disorders. Associated symptoms in the GAD criteria and autonomic hyperactivity symptoms showed convergent validity with a GAD diagnosis. However, associated symptoms of GAD were also linked to major depressive disorder (MDD), bipolar disorder, and obsessive-compulsive disorder, suggesting lack of adequate specificity. The inability of the diagnostic criteria to differentiate GAD from symptoms of other conditions highlights the need to better define its associated symptoms criteria. The relationship of overlapping symptoms between GAD and MDD is also discussed.

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

PubMed

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.

Detection methods and performance criteria for genetically modified organisms.

PubMed

Bertheau, Yves; Diolez, Annick; Kobilinsky, André; Magin, Kimberly

2002-01-01

Detection methods for genetically modified organisms (GMOs) are necessary for many applications, from seed purity assessment to compliance of food labeling in several countries. Numerous analytical methods are currently used or under development to support these needs. The currently used methods are bioassays and protein- and DNA-based detection protocols. To avoid discrepancy of results between such largely different methods and, for instance, the potential resulting legal actions, compatibility of the methods is urgently needed. Performance criteria of methods allow evaluation against a common standard. The more-common performance criteria for detection methods are precision, accuracy, sensitivity, and specificity, which together specifically address other terms used to describe the performance of a method, such as applicability, selectivity, calibration, trueness, precision, recovery, operating range, limit of quantitation, limit of detection, and ruggedness. Performance criteria should provide objective tools to accept or reject specific methods, to validate them, to ensure compatibility between validated methods, and be used on a routine basis to reject data outside an acceptable range of variability. When selecting a method of detection, it is also important to consider its applicability, its field of applications, and its limitations, by including factors such as its ability to detect the target analyte in a given matrix, the duration of the analyses, its cost effectiveness, and the necessary sample sizes for testing. Thus, the current GMO detection methods should be evaluated against a common set of performance criteria.

Validation of the classification criteria commonly used in Korea and a modified set of preliminary criteria for Behçet's disease: a multi-center study.

PubMed

Chang, H K; Lee, S S; Bai, H J; Lee, Y W; Yoon, B Y; Lee, C H; Lee, Y H; Song, G G; Chung, W T; Lee, S W; Choe, J Y; Kim, C G; Chang, D K

2004-01-01

Recently we have proposed a modified set of criteria to settle the questions raised regarding the International Study Group (ISG) criteria for Behçet's disease (BD). The aim of the present study was to validate the two pre-existing criteria sets commonly used in Korea, the ISG criteria and the criteria of the Behçet's Disease Research Committee of Japan (Japanese criteria), as well as the proposed modified criteria. The study population included 155 consecutive patients with BD and 170 controls with non-Behçet's rheumatic diseases. Detailed data for all of the subjects were recorded prospectively by the participating physicians on a standard form that listed the clinical features of BD. The sensitivity, specificity, and accuracy of each set of the criteria were measured. Of the three criteria sets employed, the modified criteria were the most accurate, with an accuracy of 96.3%. The ISG criteria often failed to classify the following patients with BD: patients with only oral and genital ulcerations, certain patients with intestinal ulcerations, patients who did not manifest oral ulcerations, and patients with acute disease but fewer than three recurrent oral ulceration relapses in a 1-year period. The Japanese criteria also failed to categorize the following patients with BD: patients with oral and genital ulcerations, and patients with oral ulcerations, skin lesions, and a positive pathergy reaction. In addition, the Japanese criteria misclassified some of the control subjects with non-Behçet's uveitis as having BD. The results of this study suggest that there are some points that need to be reconsidered in the clinical application of the two pre-existing sets of criteria. Although the modified criteria were the most accurate, further validation studies will be required in other ethnic populations.

A systematic review of diagnostic criteria for psoriasis in adults and children: evidence from studies with a primary aim to develop or validate diagnostic criteria.

PubMed

Burden-Teh, E; Phillips, R C; Thomas, K S; Ratib, S; Grindlay, D; Murphy, R

2017-11-06

The diagnosis of psoriasis in adults and children is made clinically, for both patient management and the selection of participants in research. Diagnostic criteria provide a structure for clinical assessment, which in turn helps standardize patient recruitment into clinical trials and case definitions in observational studies. The aim of this systematic review was to identify and critically appraise the published studies to date that had a primary research aim to develop or validate diagnostic criteria for psoriasis. A search of Ovid MEDLINE and Ovid Embase was conducted in October 2016. The primary objective was to record the sensitivity and specificity of diagnostic criteria for psoriasis. Secondary objectives included diagnostic recommendations, applicability to children and study characteristics. Diagnostic accuracy studies were critically appraised for risk of bias using the QUADAS-2 tool. Twenty-three studies met the inclusion criteria. None detailed clinical examination-based diagnostic criteria. The included criteria varied from genetic and molecular diagnostic models to skin imaging, histopathology, and questionnaire-based, computer-aided and traditional Chinese medicine criteria. High sensitivity and specificity (> 90%) were reported in many studies. However, the study authors often did not specify how the criteria would be used clinically or in research. This review identified studies with varying risk of bias, and due to each study developing separate criteria meta-analysis was not possible. Clinical examination-based diagnostic criteria are currently lacking for psoriasis. Future research could follow an international collaborative approach and employ study designs allowing high-quality diagnostic accuracy testing. Existing and newly developed criteria require validation. © 2017 British Association of Dermatologists.

Understanding Student Teachers' Behavioural Intention to Use Technology: Technology Acceptance Model (TAM) Validation and Testing

ERIC Educational Resources Information Center

Wong, Kung-Teck; Osman, Rosma bt; Goh, Pauline Swee Choo; Rahmat, Mohd Khairezan

2013-01-01

This study sets out to validate and test the Technology Acceptance Model (TAM) in the context of Malaysian student teachers' integration of their technology in teaching and learning. To establish factorial validity, data collected from 302 respondents were tested against the TAM using confirmatory factor analysis (CFA), and structural equation…

Translation and validation of the Malay Acceptance of Cosmetic Surgery Scale.

PubMed

Swami, Viren

2010-09-01

The present study examined the psychometric properties of a Malay translation of the Acceptance of Cosmetic Surgery Scale (ACSS; Henderson-King & Henderson-King, 2005). A total of 373 Malaysian women completed the ACSS along with measures of ideal-actual weight discrepancy, body appreciation, sociocultural attitudes toward appearance, self-esteem, life satisfaction, and demographics. Results showed that the Malay ACSS was best reduced to a two-factor solution, although an overall score of all 15 ACSS items showed the highest internal consistency. Results also showed that this overall score had good discriminant and divergent validity. It is expected that the availability of a Malay version of the ACSS will stimulate cross-cultural research on the acceptance of cosmetic surgery. Copyright © 2010 Elsevier Ltd. All rights reserved.

32 CFR 37.530 - What criteria do I use in deciding whether to accept a recipient's cost sharing?

Code of Federal Regulations, 2012 CFR

2012-07-01

... 32 National Defense 1 2012-07-01 2012-07-01 false What criteria do I use in deciding whether to accept a recipient's cost sharing? 37.530 Section 37.530 National Defense Department of Defense OFFICE OF THE SECRETARY OF DEFENSE DoD GRANT AND AGREEMENT REGULATIONS TECHNOLOGY INVESTMENT AGREEMENTS Pre...

32 CFR 37.530 - What criteria do I use in deciding whether to accept a recipient's cost sharing?

Code of Federal Regulations, 2011 CFR

2011-07-01

... 32 National Defense 1 2011-07-01 2011-07-01 false What criteria do I use in deciding whether to accept a recipient's cost sharing? 37.530 Section 37.530 National Defense Department of Defense OFFICE OF THE SECRETARY OF DEFENSE DoD GRANT AND AGREEMENT REGULATIONS TECHNOLOGY INVESTMENT AGREEMENTS Pre...

32 CFR 37.530 - What criteria do I use in deciding whether to accept a recipient's cost sharing?

Code of Federal Regulations, 2010 CFR

2010-07-01

... 32 National Defense 1 2010-07-01 2010-07-01 false What criteria do I use in deciding whether to accept a recipient's cost sharing? 37.530 Section 37.530 National Defense Department of Defense OFFICE OF THE SECRETARY OF DEFENSE DoD GRANT AND AGREEMENT REGULATIONS TECHNOLOGY INVESTMENT AGREEMENTS Pre...

32 CFR 37.530 - What criteria do I use in deciding whether to accept a recipient's cost sharing?

Code of Federal Regulations, 2014 CFR

2014-07-01

... 32 National Defense 1 2014-07-01 2014-07-01 false What criteria do I use in deciding whether to accept a recipient's cost sharing? 37.530 Section 37.530 National Defense Department of Defense OFFICE OF THE SECRETARY OF DEFENSE DoD GRANT AND AGREEMENT REGULATIONS TECHNOLOGY INVESTMENT AGREEMENTS Pre...

32 CFR 37.530 - What criteria do I use in deciding whether to accept a recipient's cost sharing?

Code of Federal Regulations, 2013 CFR

2013-07-01

... 32 National Defense 1 2013-07-01 2013-07-01 false What criteria do I use in deciding whether to accept a recipient's cost sharing? 37.530 Section 37.530 National Defense Department of Defense OFFICE OF THE SECRETARY OF DEFENSE DoD GRANT AND AGREEMENT REGULATIONS TECHNOLOGY INVESTMENT AGREEMENTS Pre...

Peace, Equanimity, and Acceptance in the Cancer Experience (PEACE): Validation of a scale to assess acceptance and struggle with terminal illness

PubMed Central

Mack, Jennifer W.; Nilsson, Matthew; Balboni, Tracy; Friedlander, Robert J.; Block, Susan D.; Trice, Elizabeth; Prigerson, Holly G.

2013-01-01

Objectives The role of emotional acceptance of a terminal illness in end-of-life (EOL) care is not known. We developed a measure of peaceful acceptance at the EOL, and evaluated the role of peaceful acceptance in EOL decision-making and care. Methods We developed the Peace, Equanimity, and Acceptance in the Cancer Experience (PEACE) questionnaire to measure the extent to which patients with advanced cancer feel a sense of peaceful acceptance of their terminal illness. The scale was administered to 160 advanced cancer patients along with measures of other attributes hypothesized to be related to acceptance, including cognitive acceptance of terminal illness. EOL outcomes in 56 patients who died during the study were also examined. Results The 12-item PEACE questionnaire had two subscales: a 7-item Struggle with Illness (Cronbach's α =.81) and a 5-item Peaceful Acceptance (α = .78) subscale. Both subscales were associated with patients’ self-reported peacefulness (r=.66 for acceptance, P<.0001; r=−.37 for struggle, P<.0001.) Struggle with Illness scores were associated with cognitive terminal illness acknowledgement (mean scores 14.9 versus 12.4, P=.001) and some aspects of advance care planning (living will or health care proxy, mean scores 13.9 versus 11.5, P=.02). In addition, among patients who had died, use of a feeding tube at the EOL was inversely associated with Peaceful Acceptance (P=.015). Conclusion The PEACE questionnaire is a valid and reliable measure of Peaceful Acceptance and Struggle with Illness. Scores are associated with some choices for EOL care among patients with advanced cancer. PMID:18429006

Validation of criteria for selective his bundle and para-hisian permanent pacing.

PubMed

Cantù, F; De Filippo, P; Cardano, P; De Luca, A; Gavazzi, A

2006-12-01

His Bundle (HB) pacing is a valid alternative to right ventricular pacing for patients with preserved His-ventricle conduction who are candidates for permanent stimulation. Permanent pacing in the HB area enables Selective HB pacing (SHBP) or para-Hisian pacing (PHP) to be achieved. The aim of our study was to draw up a set of easy criteria to differentiate and validate the two kinds of stimulations according to the pacing output and the ECG/EKG signals. From February to July 2005, 17 patients eligible for a pacemaker (PM) procedure underwent implantation with the Medtronic SelectSecure lead (Medtronic, Minneapolis, MN, USA) screwed into the HB area.SHBP was defined when the intrinsic QRS was equal, in both duration and morphology, to the paced QRS, the His-Ventricular (H-V) interval was equal to Pace-Ventricular interval (Vp-V) and, at low output, only the HB was captured, while increasing the output resulted in both the HB and right ventricular (RV) being captured (widening of QRS at high output). Conversely, PHP was defined when the intrinsic QRS differed from the paced one, either in morphology or in duration and, at high output, both the RV and HB were captured (non-SHBP), while decreasing the output resulted in losing HB capture (widening of QRS at low output). According to these criteria, SHBP was achieved in 11 patients, while in the remaining 6, PHP was obtained. No adverse events were reported. The above criteria enabled SHBP and PHP to be validated easily and clearly. A longer follow-up will be needed in order to ascertain whether the clinical outcome of these two approaches differs.

A Brief Measure of Peer Affiliation and Social Acceptance (PASA): Validity in an Ethnically Diverse Sample of Early Adolescents

PubMed Central

Dishion, Thomas J.; Kim, Hanjoe; Stormshak, Elizabeth A.; O'Neill, Maya

2014-01-01

Objective Conduct a multiagent–multimethod analysis of the validity of a brief measure of deviant peer affiliations and social acceptance (PASA) in young adolescents. Peer relationships are critical to child and adolescent social and emotional development, but currently available measures are tedious and time consuming. The PASA consists of a youth, parent, and teacher report that can be collected longitudinally to study development and intervention effectiveness. Method This longitudinal study included 998 middle school students and their families. We collected the PASA and peer sociometrics data in Grade 7 and a multiagent–multimethod construct of deviant peer clustering in Grade 8. Results Confirmatory factor analyses of the multiagent–multimethod data revealed that the constructs of deviant peer affiliations and social acceptance and rejection were distinguishable as unique but correlated constructs within the PASA. Convergent, discriminant, concurrent, and predictive validity of the PASA was satisfactory, although the acceptance and rejection constructs were highly correlated and showed similar patterns of concurrent validity. Factor invariance was established for mother and for father reports. Conclusions Results suggest that the PASA is a valid and reliable measure of peer affiliation and of social acceptance among peers during the middle school years and provides a comprehensive yet brief assessment of peer affiliations and social acceptance. PMID:24611623

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

PubMed

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

Industry Application Emergency Core Cooling System Cladding Acceptance Criteria Early Demonstration

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

Szilard, Ronaldo H.; Youngblood, Robert W.; Zhang, Hongbin

2015-09-01

The U. S. NRC is currently proposing rulemaking designated as “10 CFR 50.46c” to revise the loss-of-coolant-accident (LOCA)/emergency core cooling system (ECCS) acceptance criteria to include the effects of higher burnup on cladding performance as well as to address other technical issues. The NRC is also currently resolving the public comments with the final rule expected to be issued in April 2016. The impact of the final 50.46c rule on the industry may involve updating of fuel vendor LOCA evaluation models, NRC review and approval, and licensee submittal of new LOCA evaluations or re-analyses and associated technical specification revisions formore » NRC review and approval. The rule implementation process, both industry and NRC activities, is expected to take 4-6 years following the rule effective date. As motivated by the new rule, the need to use advanced cladding designs may be a result. A loss of operational margin may result due to the more restrictive cladding embrittlement criteria. Initial and future compliance with the rule may significantly increase vendor workload and licensee cost as a spectrum of fuel rod initial burnup states may need to be analyzed to demonstrate compliance. Consequently, there will be an increased focus on licensee decision making related to LOCA analysis to minimize cost and impact, and to manage margin. The proposed rule would apply to a light water reactor and to all cladding types.« less

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

PubMed

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.

Criteria for the validity of clinical trials of treatments of cohorts of cancer patients based on the Hardin Jones principle.

PubMed Central

Pauling, L; Herman, Z S

1989-01-01

With the assumption of the validity of the Hardin Jones principle that the death rate of members of a homogeneous cohort of cancer patients is constant, three criteria for the validity of clinical trials of cancer treatments are formulated. These criteria are satisfied by most published clinical trials, but one trial was found to violate all three, rendering the validity of its reported results uncertain. PMID:2780542

The influence of validity criteria on Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) test-retest reliability among high school athletes.

PubMed

Brett, Benjamin L; Solomon, Gary S

2017-04-01

Research findings to date on the stability of Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) Composite scores have been inconsistent, requiring further investigation. The use of test validity criteria across these studies also has been inconsistent. Using multiple measures of stability, we examined test-retest reliability of repeated ImPACT baseline assessments in high school athletes across various validity criteria reported in previous studies. A total of 1146 high school athletes completed baseline cognitive testing using the online ImPACT test battery at two time periods of approximately two-year intervals. No participant sustained a concussion between assessments. Five forms of validity criteria used in previous test-retest studies were applied to the data, and differences in reliability were compared. Intraclass correlation coefficients (ICCs) ranged in composite scores from .47 (95% confidence interval, CI [.38, .54]) to .83 (95% CI [.81, .85]) and showed little change across a two-year interval for all five sets of validity criteria. Regression based methods (RBMs) examining the test-retest stability demonstrated a lack of significant change in composite scores across the two-year interval for all forms of validity criteria, with no cases falling outside the expected range of 90% confidence intervals. The application of more stringent validity criteria does not alter test-retest reliability, nor does it account for some of the variation observed across previously performed studies. As such, use of the ImPACT manual validity criteria should be utilized in the determination of test validity and in the individualized approach to concussion management. Potential future efforts to improve test-retest reliability are discussed.

[Organization of socially acceptable working hours in nursing].

PubMed

Büssing, A; Glaser, J

1994-05-01

Three dimensions in the structure of the working hour system of nurses, rendering them socially acceptable, are becoming important: duration of the working day, the time of day which is being worked and the distribution of working hours. The latter two are of particular importance because flexible shift is becoming the dominant pattern in nursing. Six indicators are discussed as criteria for social acceptability: security of employment which includes access to the labour-market, level of income, health, opportunity for social relationships, social participation, and autonomy. Responses of 297 nurses in one General Hospital taking part in a study, were analysed to examine empirically the concept of 'socially acceptable structure of the working hours'. Ideal and factual patterns are considered first. Secondly aspects of autonomy are considered and the way this depends on time, thirdly the criteria used to define 'social acceptability' are examined for validity. Results show firstly the cross contrast between the hospital's expectation and the nurses' wishes with regard to working hours. Furthermore, inspite of the demand for flexibility, staff have very little choice and there is little sign of joint decision making. Thirdly results show that health, interpersonal and social aspects are of special importance and that, correspondingly, in the view of nurses, financial and practical problems are of lesser importance in their every day life.

Peace, Equanimity, and Acceptance in the Cancer Experience (PEACE): validation of a scale to assess acceptance and struggle with terminal illness.

PubMed

Mack, Jennifer W; Nilsson, Matthew; Balboni, Tracy; Friedlander, Robert J; Block, Susan D; Trice, Elizabeth; Prigerson, Holly G

2008-06-01

The role of emotional acceptance of a terminal illness in end-of-life (EOL) care is not known. The authors developed a measure of peaceful acceptance at the EOL, and evaluated the role of peaceful acceptance in EOL decision-making and care. The authors developed the Peace, Equanimity, and Acceptance in the Cancer Experience (PEACE) questionnaire to measure the extent to which patients with advanced cancer have a sense of peaceful acceptance of their terminal illness. The scale was administered to 160 patients with advanced cancer along with measures of other attributes that hypothetically are related to acceptance, including cognitive acceptance of terminal illness. EOL outcomes in 56 patients who died during the study also were examined. The 12-item PEACE questionnaire had 2 subscales: a 7-item Struggle With Illness subscale (Cronbach alpha = .81) and a 5-item Peaceful Acceptance subscale (alpha = .78). Both subscales were associated with patients' self-reported peacefulness (correlation coefficient [r] = 0.66 for acceptance [P <.0001]; r = -0.37 for struggle [P < .0001]). Struggle With Illness scores were associated with cognitive terminal illness acknowledgment (mean scores, 14.9 vs 12.4 for patients who were not aware that their illness was terminal; P = .001) and with some aspects of advance care planning (living will or healthcare proxy: mean scores, 13.9 vs 11.5; P = .02). In addition, among patients who had died, the use of a feeding tube at the EOL was associated inversely with Peaceful Acceptance (P = .015). The current study indicated that the PEACE questionnaire is a valid and reliable measure of peaceful acceptance and struggle with illness. Scores were associated with some choices for EOL care among patients with advanced cancer. (c) 2008 American Cancer Society.

Development and Validation of the Self-Acceptance Scale for Persons with Early Blindness: The SAS-EB

PubMed Central

Morgado, Fabiane Frota da Rocha; Campana, Angela Nogueira Neves Betanho; Tavares, Maria da Consolação Gomes Cunha Fernandes

2014-01-01

Investigations of self-acceptance are critical to understanding the development and maintenance of psychological health. However, valid and reliable instruments for measuring self-acceptance in persons with early blindness have yet to be developed. The current research describes three studies designed to develop and validate the Self-acceptance Scale for Persons with Early Blindness (SAS-EB). In Study 1, we developed the initial item pool. Thirty-three items were generated, based on data from specialized literature and from 2 focus groups. Items were organized in a three-factor structure, theoretically predicted for SAS-EB - (1) body acceptance, (2) self-protection from social stigmas, and (3) feeling and believing in one's capacities. In Study 2, information obtained from a panel of 9 experts and 22 persons with early blindness representing the target population was used to refine the initial item pool, generating a new pool of 27 items. In Study 3, 318 persons with early blindness (141 women and 177 men), between 18 and 60 years of age (M = 37.74 years, SD = 12.37) answered the new pool of 27 items. After the elimination of 9 items using confirmatory factor analysis, we confirmed the theoretical three-factor structure of the SAS-EB. Study 3 also provided support for the scale's internal consistency and construct validity. Finally, the psychometric properties of the SAS-EB, its utility, and its limitations are discussed along with considerations for future research. PMID:25268633

International validation study for interim PET in ABVD-treated, advanced-stage hodgkin lymphoma: interpretation criteria and concordance rate among reviewers.

PubMed

Biggi, Alberto; Gallamini, Andrea; Chauvie, Stephane; Hutchings, Martin; Kostakoglu, Lale; Gregianin, Michele; Meignan, Michel; Malkowski, Bogdan; Hofman, Michael S; Barrington, Sally F

2013-05-01

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. This paper focuses on the criteria for interpretation of interim PET and on concordance rates. A cohort of advanced-stage Hodgkin lymphoma patients treated with doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) were enrolled retrospectively from centers worldwide. Baseline and interim scans were reviewed by an international panel of 6 nuclear medicine experts using the 5-point score. Complete scan datasets of acceptable diagnostic quality were available for 260 of 440 (59%) enrolled patients. Independent agreement among reviewers was reached on 252 of 260 patients (97%), for whom at least 4 reviewers agreed the findings were negative (score of 1-3) or positive (score of 4-5). After discussion, consensus was reached in all cases. There were 45 of 260 patients (17%) with positive interim PET findings and 215 of 260 patients (83%) with negative interim PET findings. Thirty-three interim PET-positive scans were true-positive, and 12 were false-positive. Two hundred three interim PET-negative scans were true-negative, and 12 were false-negative. Sensitivity, specificity, and accuracy were 0.73, 0.94, and 0.91, respectively. Negative predictive value and positive predictive value were 0.94 and 0.73, respectively. The 3-y failure-free survival was 83%, 28%, and 95% for the entire population and for interim PET-positive and -negative patients, respectively (P < 0.0001). The

[Acceptance of tinnitus: Validation of the ‛Akzeptanzfragebogen bei chronischem Tinnitus' (AFCT)].

PubMed

Riedl, D; Rumpold, G; Schmidt, A; Bliem, H R; Moschen, R

2014-12-01

Tinnitus is a widely spread symptom, which is perceived chronically by approximately 10% of the population. The vast majority of the tinnitus patients doesn´t feel impaired through the ear noise, but about 5-30% of the tinnitus patient are suffering in their everyday life. Whether severe distress is experienced cannot be explained by the quality of the ear noise itself (i. e. loudness or duration). Newer research tends to explain the difference in the experienced strain by the concept of acceptance. The aim of this study was to analyze the psychometric quality of a German Version of the "Chronic Pain Acceptance Ques-tionnaire" (CPAQ), namely the "Akzeptanzfragebogen bei chronischem Tinnitus" (AFCT) which has been adapted for tinnitus. 97 patients with chronic tinnitus have been tested at the start of an outpatient tinnitus group therapy. The following questionnaires were used: "Akzeptanzfragebogen bei chronischem Tinnitus" (AFCT) and "Tinnitusfragebogen" (TF). The structure of the AFCT was determined by a factor analysis. The reliability was evaluated by the estimation of the internal consistency (Cronbach Alpha). Due to psychometric weakness and unclear factorial loadings 8 items have been removed. Out of the remaining 12 items the AFCT-12 has been developed. The AFCT-12 consists of 2 factors, which explain a variance of 54.9%. Both AFCT-12 and AFCT have a satisfactory reliability and validity. The results demonstrate that the AFCT-12 is a reliable and valid instrument to measure the acceptance of patients suffering from chronic tinnitus. © Georg Thieme Verlag KG Stuttgart · New York.

Non Destructive Test Dye Penetrant and Ultrasonic on Welding SMAW Butt Joint with Acceptance Criteria ASME Standard

NASA Astrophysics Data System (ADS)

Endramawan, T.; Sifa, A.

2018-02-01

The purpose of this research is to know the type of discontinuity of SMAW welding result and to determine acceptance criteria based on American Society of Mechanical Engineer (ASME) standard. Material used is mild steel 98,71% Fe and 0,212% C with hardness 230 VHN with specimen diameter 20 cm and thickness 1.2 cm which is welded use SMAW butt joint with electrode for rooting LB 52U diameter 2.6 mm, current 70 Ampere and voltage 380 volt, filler used LB 5218 electrode diameter 3.2 mm with current 80 Ampere and 380 volt. The method used to analyze the welded with non destructive test dye penetrant (PT) method to see indication on the surface of the object and Ultrasonic (UT) to see indication on the sub and inner the surface of the object, the result is discontinuity recorded and analyzed and then the discontinuity is determine acceptance criteria based on the American Society of Mechanical Engineer (ASME) standards. The result show the discontinuity of porosity on the surface of the welded and inclusion on sub material used ultrasonic test, all indication on dye penetrant or ultrasonic test if there were rejected of result of welded that there must be gouging on part which rejected and then re-welding.

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

PubMed Central

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.

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

MacDonell, M.; Bhattacharyya, M.; Finster, M.

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 contaminantsmore » 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

Measuring Acceptance of Sleep Difficulties: The Development of the Sleep Problem Acceptance Questionnaire.

PubMed

Bothelius, Kristoffer; Jernelöv, Susanna; Fredrikson, Mats; McCracken, Lance M; Kaldo, Viktor

2015-11-01

Acceptance may be an important therapeutic process in sleep medicine, but valid psychometric instruments measuring acceptance related to sleep difficulties are lacking. The purpose of this study was to develop a measure of acceptance in insomnia, and to examine its factor structure as well as construct validity. In a cross-sectional design, a principal component analysis for item reduction was conducted on a first sample (A) and a confirmatory factor analysis on a second sample (B). Construct validity was tested on a combined sample (C). Questionnaire items were derived from a measure of acceptance in chronic pain, and data were gathered through screening or available from pretreatment assessments in four insomnia treatment trials, administered online, via bibliotherapy and in primary care. Adults with insomnia: 372 in sample A and 215 in sample B. Sample C (n = 820) included sample A and B with another 233 participants added. Construct validity was assessed through relations with established acceptance and sleep scales. The principal component analysis presented a two-factor solution with eight items, explaining 65.9% of the total variance. The confirmatory factor analysis supported the solution. Acceptance of sleep problems was more closely related to subjective symptoms and consequences of insomnia than to diary description of sleep, or to acceptance of general private events. The Sleep Problem Acceptance Questionnaire (SPAQ), containing the subscales "Activity Engagement" and "Willingness", is a valid tool to assess acceptance of insomnia. © 2015 Associated Professional Sleep Societies, LLC.

Predictive Validity of DSM-IV and ICD-10 Criteria for ADHD and Hyperkinetic Disorder

ERIC Educational Resources Information Center

Lee, Soyoung I.; Schachar, Russell J.; Chen, Shirley X.; Ornstein, Tisha J.; Charach, Alice; Barr, Cathy; Ickowicz, Abel

2008-01-01

Background: The goal of this study was to compare the predictive validity of the two main diagnostic schemata for childhood hyperactivity--attention-deficit hyperactivity disorder (ADHD; "Diagnostic and Statistical Manual"-IV) and hyperkinetic disorder (HKD; "International Classification of Diseases"-10th Edition). Methods: Diagnostic criteria for…

Reinforced concrete pipe cracks : acceptance criteria [summary].

DOT National Transportation Integrated Search

2011-01-01

Reinforced concrete pipe (RCP) is widely used by the Florida Department of Transportation (FDOT) in installations expected to serve for periods of decades before replacement, and extremely slow deterioration of RCP can be accepted. However, cracks in...

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

PubMed Central

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

[Validation of the American College of Rheumatology classification criteria for primary Sjogren's syndrome in Chinese patients].

PubMed

Wei, Pan; Lu, Song-he; Fu, Jing-ya; Yan, Zhi-min; Hua, Hong

2014-04-18

To validate the American College of Rheumatology Classification (ACR) Criteria (2012) for the diagnosis of primary Sjogren's syndrome in Chinese patients. All patients involved in this study came from the Department of Oral Medicine Peking University Stomatology Hospital. They were devided into two groups of pSS and non-pSS according to the diagnoses made by two experts. Both groups of the patients had completed medical records kept in the hospital. A total of 239 pSS patients (160 with labial salivary gland biopsy, and 79 without biopsy) and 52 age-matched non-pSS patients [(55.17±14.295),and (55.90±13.38) years old, P>0.05] (9 with biopsy, and 43 without biopsy) were involved in this study. The sensitivity and specificity of ACR criteria in diagnosing pSS were 90.37 % and 88.46 % respectively. The positive and negative likelihood ratios were 7.83 and 0.109, respectively. The sensitivities of ACR criteria in diagnosing pSS patients with and without labial biopsy were 88.75% and 93.67 %, respectively, with specificities of 88.89% and 88.37%, respectively. The most sensitive item adopted in ACR criteria was the ocular staining score with a sensitivity of 85.77%, and the most specific item was the labial salivary gland biopsy, with a specificity of 88.89%. The sensitivity and specificity of ACR criteria in diagnosing Chinese pSS patients were relatively high, and may serve as the diagnosis criteria in research and clinical practice. However, the ACR criteria need to be validated and further revised in the future .

Validation of the German patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE™).

PubMed

Hagelstein, V; Ortland, I; Wilmer, A; Mitchell, S A; Jaehde, U

2016-12-01

Integrating the patient's perspective has become an increasingly important component of adverse event reporting. The National Cancer Institute has developed a Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™). This instrument has been translated into German and linguistically validated; however, its quantitative measurement properties have not been evaluated. A German language survey that included 31 PRO-CTCAE items, as well as the EORTC QLQ-C30 and the Oral Mucositis Daily Questionnaire (OMDQ), was distributed at 10 cancer treatment settings in Germany and Austria. Item quality was assessed by analysis of acceptability and comprehensibility. Reliability was evaluated by using Cronbach's' alpha and validity by principal components analysis (PCA), multitrait-multimethod matrix (MTMM) and known groups validity techniques. Of 660 surveys distributed to the study centres, 271 were returned (return rate 41%), and data from 262 were available for analysis. Participants' median age was 59.7 years, and 69.5% of the patients were female. Analysis of item quality supported the comprehensibility of the 31 PRO-CTCAE items. Reliability was very good; Cronbach's' alpha correlation coefficients were >0.9 for almost all item clusters. Construct validity of the PRO-CTCAE core item set was shown by identifying 10 conceptually meaningful item clusters via PCA. Moreover, construct validity was confirmed by the MTMM: monotrait-heteromethod comparison showed 100% high correlation, whereas heterotrait-monomethod comparison indicated 0% high correlation. Known groups validity was supported; PRO-CTCAE scores were significantly lower for those with impaired versus preserved health-related quality of life. A set of 31 items drawn from the German PRO-CTCAE item library demonstrated favourable measurement properties. These findings add to the body of evidence that PRO-CTCAE provides a rigorous method to capture patient self-reports of

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

PubMed Central

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

2016-01-01

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. PMID:27330655

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

PubMed

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.

[Criteria of scientific validity in research].

PubMed

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.

7 CFR 42.133 - Portion of production acceptance criteria.

Code of Federal Regulations, 2011 CFR

2011-01-01

... CONTAINER REGULATIONS STANDARDS FOR CONDITION OF FOOD CONTAINERS On-Line Sampling and Inspection Procedures... determined by comparing the calculated CuSum value with the acceptance limit (“L”) for the specified AQL. (b) A portion of production is acceptable if the CuSum value, calculated from the subgroup representing...

The Social Validity of "Acceptability of Behavioral Interventions Used in Classrooms": Inferences from Longitudinal Evidence

ERIC Educational Resources Information Center

Elliott, Stephen N.

2017-01-01

In this retrospective commentary on "Acceptability of Behavioral Interventions Used in Classrooms: The Influence of Amount of Teacher Time, Severity of Behavior Problem, and Type of Intervention," I first examine the concept of social validity and related measurement challenges per Wolf's concerns about consumers' subjective reactions to…

Safety margins in zircaloy oxidation and embrittlement criteria for emergency core cooling system acceptance

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

Williford, R.E.

1986-09-01

Current emergency core cooling system acceptance criteria for light water reactors specify that, under loss-of-coolant accident (LOCA) conditions, the Baker-Just (BJ) correlation must be used to calculate Zircaloy-steam oxidation, calculated peak cladding temperatures (PCT) must not exceed 1204/sup 0/C, and calculated oxidation must not exceed 17% equivalent cladding reacted (ECR). An appropriately defined minimum margin of safety was estimated for each of these criteria. The currently required BJ oxidation correlation provides margins only over the 1100 to 1500/sup 0/C temperature range at the 95% confidence level. The PCT margins for thermal shock and handling failures are adequate at oxidation temperaturesmore » above 1204/sup 0/C for up to 210 and 160 s, respectively, at the 95% confidence level. The ECR thermal shock and handling margins at the 50 and 95% confidence levels, respectively, range between 2 and 7% ECR for the BJ correlation, but vanish at temperatures above 1100 to 1160/sup 0/C for the best-estimate Cathcart-Pawel correlation. However, use of the Cathcart Pawel correlation for ''design basis'' LOCA calculations can be justified at the 85 to 88% confidence level if cooling rate effects can be neglected.« less

Selecting the Acceptance Criteria of Medicines in the Reimbursement List of Public Health Insurance of Iran, Using the "Borda" Method: a Pilot Study.

PubMed

Viyanchi, Amir; Rasekh, Hamid Reza; Rajabzadeh Ghatari, Ali; SafiKhani, Hamid Reza

2015-01-01

Decision-making for medicines to be accepted in Iran's public health insurance reimbursement list is a complex process and involves factors, which should be considered in applying a coverage for medicine costs. These processes and factors are not wholly assessed, while assessment of these factors is an essential need for getting a transparent and evidence-based approach toward medicine reimbursement in Iran. This paper aims to show an evidence-based approach toward medicine selection criteria to inform the medical reimbursement decision makers in Iranian health insurance organizations. To explore an adaptable decision-making framework while incorporating a method called "Borda" in medicine reimbursement assessment, we used the help of an expert group including decision makers and clinical researchers who are also policy makers to appraise the five chief criteria that have three sub criteria (Precision, Interpretability, and Cost). Also software "Math-lab"7, "SPSS" 17 and Excel 2007 were used in this study. "Borda" estimates the amount of perceived values from different criteria and creates a range from one to five while providing a comprehensive measurement of a large spectrum of criteria. Participants reported that the framework provided an efficient approach to systematic consideration in a pragmatic format consisting of many parts to guide decision-makings, including criteria and value (a model with the core of Borda) and evidences (medicine reimbursement based on criteria). The most important criterion for medicine acceptance in health insurance companies, in Iran, is the "life-threatening" factor and "evidence quality" is accounted as the fifth important factor. This pilot study showed the usefulness of incorporating Borda in medicine reimbursement decisions to support a transparent and systematic appraisal of health insurance companies' deeds. Further research is needed to advance Borda-based approaches that are effective on health insurance decision making.

Assessment of safety margins in zircaloy oxidation and embrittlement criteria for ECCS acceptance

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

Williford, R.E.

1986-04-01

Current Emergency Core Cooling System (ECCS) Acceptance Criteria for light-water reactors include certain requirements pertaining to calculations of core performance during a Loss of Coolant Accident (LOCA). The Baker-Just correlation must be used to calculate Zircaloy-steam oxidation, calculated peak cladding temperatures (PCT) must not exceed 1204/sup 0/C, and calculated oxidation must not exceed 17% equivalent cladding reacted (17% ECR). The minimum margin of safety was estimated for each of these criteria, based on research performed in the last decade. Margins were defined as the amounts of conservatism over and above the expected extreme values computed from the data base atmore » specified confidence levels. The currently required Baker-Just oxidation correlation provides margins only over the 1100/sup 0/C to 1500/sup 0/C temperature range at the 95% confidence level. The PCT margins for thermal shock and handling failures are adequate at oxidation temperatures above 1204/sup 0/C for 210 and 160 seconds, respectively, at the 95% confidence level. ECR thermal shock and handling margins at the 50% and 95% confidence levels, respectively, range between 2% and 7% ECR for the Baker-Just correlation, but vanish at temperatures between 1100/sup 0/C and 1160/sup 0/C for the best-estimate Cathcart-Pawel correlation. Use of the Cathcart-Pawel correlation for LOCA calculations can be justified at the 85% to 88% confidence level if cooling rate effects can be neglected. 75 refs., 21 figs.« less

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

PubMed Central

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

2013-01-01

Purpose 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. Methods 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. Results 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. 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. PMID:24646897

Selecting the Acceptance Criteria of Medicines in the Reimbursement List of Public Health Insurance of Iran, Using the “Borda” Method: a Pilot Study

PubMed Central

Viyanchi, Amir; Rasekh, Hamid Reza; Rajabzadeh Ghatari, Ali; SafiKhani, Hamid Reza

2015-01-01

Decision-making for medicines to be accepted in Iran’s public health insurance reimbursement list is a complex process and involves factors, which should be considered in applying a coverage for medicine costs. These processes and factors are not wholly assessed, while assessment of these factors is an essential need for getting a transparent and evidence-based approach toward medicine reimbursement in Iran. This paper aims to show an evidence-based approach toward medicine selection criteria to inform the medical reimbursement decision makers in Iranian health insurance organizations. To explore an adaptable decision-making framework while incorporating a method called “Borda” in medicine reimbursement assessment, we used the help of an expert group including decision makers and clinical researchers who are also policy makers to appraise the five chief criteria that have three sub criteria (Precision, Interpretability, and Cost). Also software “Math-lab”7, “SPSS” 17 and Excel 2007 were used in this study. “Borda” estimates the amount of perceived values from different criteria and creates a range from one to five while providing a comprehensive measurement of a large spectrum of criteria. Participants reported that the framework provided an efficient approach to systematic consideration in a pragmatic format consisting of many parts to guide decision-makings, including criteria and value (a model with the core of Borda) and evidences (medicine reimbursement based on criteria). The most important criterion for medicine acceptance in health insurance companies, in Iran, is the "life-threatening" factor and "evidence quality" is accounted as the fifth important factor. This pilot study showed the usefulness of incorporating Borda in medicine reimbursement decisions to support a transparent and systematic appraisal of health insurance companies' deeds. Further research is needed to advance Borda-based approaches that are effective on health insurance

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

PubMed

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.

Research Diagnostic Criteria for Temporomandibular Disorders: Validity of Axis I Diagnoses

PubMed Central

Truelove, Edmond; Pan, Wei; Look, John O.; Mancl, Lloyd A.; Ohrbach, Richard K.; Velly, Ana; Huggins, Kimberly; Lenton, Patricia; Schiffman, Eric L.

2011-01-01

AIMS To estimate the criterion validity of the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) Axis I TMD diagnoses. METHODS A combined total of 614 TMD community and clinic cases and 91 controls were examined at 3 study sites. RDC/TMD Axis I diagnoses were algorithmically derived from an examination performed by calibrated dental hygienists. Reference standards (Gold Standards) were established by means of consensus diagnoses rendered by 2 TMD experts using all available clinical data, including imaging studies. Validity of the RDC/TMD Axis I TMD diagnoses was estimated relative to reference-standard diagnoses (gold standard diagnoses). Target sensitivity and specificity were set a priori at ≥ 0.70 and ≥ 0.95, respectively. RESULTS Target sensitivity and specificity were not observed for any of the 8 RDC/TMD diagnoses. The highest validity was achieved for Group Ia myofascial pain (sensitivity 0.65, specificity 0.92) and Group Ib myofascial pain with limited opening (sensitivity 0.79, specificity 0.92). Target sensitivity and specificity were observed only when both Group I diagnoses were combined (0.87 and 0.98, respectively). For Group II (disc displacements) and Group III (arthralgia, arthritis, arthrosis) diagnoses, all estimates for sensitivity were below target (0.03 to 0.53), and specificity ranged from below to on target (0.86 to 0.99). CONCLUSION The RDC/TMD Axis I TMD diagnoses did not reach the targets set at sensitivity of ≥ 0.70 and specificity of ≥ 0.95. Target validity was obtained only for myofascial pain without differentiation between normal and limited opening. Revision of the current Axis I TMD diagnostic algorithms is warranted to improve their validity. PMID:20213030

What Adherence Measures Should Be Used in Trials of Home-Based Rehabilitation Interventions? A Systematic Review of the Validity, Reliability, and Acceptability of Measures.

PubMed

Frost, Rachael; Levati, Sara; McClurg, Doreen; Brady, Marian; Williams, Brian

2017-06-01

To systematically review methods for measuring adherence used in home-based rehabilitation trials and to evaluate their validity, reliability, and acceptability. In phase 1 we searched the CENTRAL database, NHS Economic Evaluation Database, and Health Technology Assessment Database (January 2000 to April 2013) to identify adherence measures used in randomized controlled trials of allied health professional home-based rehabilitation interventions. In phase 2 we searched the databases of MEDLINE, Embase, CINAHL, Allied and Complementary Medicine Database, PsycINFO, CENTRAL, ProQuest Nursing and Allied Health, and Web of Science (inception to April 2015) for measurement property assessments for each measure. Studies assessing the validity, reliability, or acceptability of adherence measures. Two reviewers independently extracted data on participant and measure characteristics, measurement properties evaluated, evaluation methods, and outcome statistics and assessed study quality using the COnsensus-based Standards for the selection of health Measurement INstruments checklist. In phase 1 we included 8 adherence measures (56 trials). In phase 2, from the 222 measurement property assessments identified in 109 studies, 22 high-quality measurement property assessments were narratively synthesized. Low-quality studies were used as supporting data. StepWatch Activity Monitor validly and acceptably measured short-term step count adherence. The Problematic Experiences of Therapy Scale validly and reliably assessed adherence to vestibular rehabilitation exercises. Adherence diaries had moderately high validity and acceptability across limited populations. The Borg 6 to 20 scale, Bassett and Prapavessis scale, and Yamax CW series had insufficient validity. Low-quality evidence supported use of the Joint Protection Behaviour Assessment. Polar A1 series heart monitors were considered acceptable by 1 study. Current rehabilitation adherence measures are limited. Some possess

The Theory of Planned Behavior (TPB) and Pre-Service Teachers' Technology Acceptance: A Validation Study Using Structural Equation Modeling

ERIC Educational Resources Information Center

Teo, Timothy; Tan, Lynde

2012-01-01

This study applies the theory of planned behavior (TPB), a theory that is commonly used in commercial settings, to the educational context to explain pre-service teachers' technology acceptance. It is also interested in examining its validity when used for this purpose. It has found evidence that the TPB is a valid model to explain pre-service…

Acceptability and validity of older driver screening with the DrivingHealth Inventory.

PubMed

Edwards, Jerri D; Leonard, Kathleen M; Lunsman, Melissa; Dodson, Joan; Bradley, Stacy; Myers, Charlsie A; Hubble, Bridgette

2008-05-01

Research has indicated that technology can be effectively used to identify high-risk older drivers. However, adaptation of such technology has been limited. Researchers debate whether older drivers represent a safety problem as well as whether they should be screened for driving fitness. The present study examined how drivers feel regarding technological screening and mandatory state testing. The validity and acceptability of a new technological screening battery for identifying high-risk drivers, the DrivingHealth Inventory (DHI), was also evaluated. In a sample of 258 Alabama drivers aged 18-87, older drivers performed significantly worse than younger drivers on sensory, cognitive, and physical subtests of the DHI, and older drivers with a crash history performed worse than older drivers without crashes. Regardless of age, 90% of participants supported states requiring screening for older drivers' license renewal. The majority of the participants (72%) supported use of technological screening batteries such as the DHI as a driver screening tool. Considering the acceptability and potential efficacy of the DHI, it may be a useful tool in evaluating driving fitness among older adults.

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

ERIC Educational Resources Information Center

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…

Use of soft data for multi-criteria calibration and validation of APEX: Impact on model simulations

USDA-ARS?s Scientific Manuscript database

It is widely known that the use of soft data and multiple model performance criteria in model calibration and validation is critical to ensuring the model capture major hydrologic and water quality processes. The Agricultural Policy/Environmental eXtender (APEX) is a hydrologic and water quality mod...

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

PubMed

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

Considerations for Test Selection: How Do Validity and Reliability Impact Diagnostic Decisions?

ERIC Educational Resources Information Center

Friberg, Jennifer C.

2010-01-01

Nine preschool and school-age language assessment tools found to have acceptable levels of identification accuracy were evaluated to determine their overall levels of psychometric validity for use in diagnosing the presence/absence of language impairment. Eleven specific criteria based on those initially devised by McCauley and Swisher (1984) were…

A Cross-Cultural Validity of the E-Learning Acceptance Measure (ElAM) in Lebanon and England: A Confirmatory Factor Analysis

ERIC Educational Resources Information Center

Tarhini, Ali; Teo, Timothy; Tarhini, Takwa

2016-01-01

Despite the prevalence and significance of e-learning in education, there is a dearth of published instruments for educational researchers and practitioners that measure users' acceptance of e-learning. To meet this need, Teo (2010) developed the E-learning Acceptance Measure (ElAM). The main objective of this paper is to validate the ElAM (Teo,…

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

ERIC Educational Resources Information Center

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…

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

PubMed

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 < .001) and health anxiety (r = 0.71, p < .001), and moderately associated with general anxiety (r = 0.35, p < .001) and depressive symptoms (r = 0.22, p < .001). Patients with a higher SSD-12 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.

A FRAMEWORK TO DEVELOP FLAW ACCEPTANCE CRITERIA FOR STRUCTURAL INTEGRITY ASSESSMENT OF MULTIPURPOSE CANISTERS FOR EXTENDED STORAGE OF USED NUCLEAR FUEL

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

Lam, P.; Sindelar, R.; Duncan, A.

2014-04-07

A multipurpose canister (MPC) made of austenitic stainless steel is loaded with used nuclear fuel assemblies and is part of the transfer cask system to move the fuel from the spent fuel pool to prepare for storage, and is part of the storage cask system for on-site dry storage. This weld-sealed canister is also expected to be part of the transportation package following storage. The canister may be subject to service-induced degradation especially if exposed to aggressive environments during possible very long-term storage period if the permanent repository is yet to be identified and readied. Stress corrosion cracking may bemore » initiated on the canister surface in the welds or in the heat affected zone because the construction of MPC does not require heat treatment for stress relief. An acceptance criteria methodology is being developed for flaw disposition should the crack-like defects be detected by periodic Inservice Inspection. The external loading cases include thermal accident scenarios and cask drop conditions with the contribution from the welding residual stresses. The determination of acceptable flaw size is based on the procedure to evaluate flaw stability provided by American Petroleum Institute (API) 579 Fitness-for-Service (Second Edition). The material mechanical and fracture properties for base and weld metals and the stress analysis results are obtained from the open literature such as NUREG-1864. Subcritical crack growth from stress corrosion cracking (SCC), and its impact on inspection intervals and acceptance criteria, is not addressed.« less

Preliminary Criteria for Global Flares in Childhood-Onset Systemic Lupus Erythematosus

PubMed Central

Brunner, Hermine I.; Mina, Rina; Pilkington, Clarissa; Beresford, Michael W.; Reiff, Andreas; Levy, Deborah M.; Tucker, Lori B.; Eberhard, B. Anne; Ravelli, Angelo; Schanberg, Laura E.; Saad-Magalhaes, Claudia; Higgins, Gloria C.; Onel, Karen; Singer, Nora G.; von Scheven, Emily; Itert, Lukasz; Klein-Gitelman, Marisa S.; Punaro, Marilynn; Ying, Jun; Giannini, Edward H.

2011-01-01

Objectives To develop widely acceptable preliminary criteria of global flare for childhood-onset SLE (cSLE). Methods Pediatric rheumatologists (n=138) rated a total of 358 unique patient profiles (PP) with information about the cSLE flare descriptors (cSLE-FD) from two consecutive visits: patient global assessment of well-being, physician global assessment of disease activity (MD-global), health-related quality of life, anti-dsDNA antibodies, disease activity index score, protein/creatinine (P/C) ratio, complement levels and ESR. Based on 2996 rater responses about the course of cSLE (baseline vs. follow-up) the accuracy (sensitivity, specificity, area under the receiver operating characteristic curve) of candidate flare criteria was assessed. An international consensus conference was held to rank these candidate flare criteria as per the ACR-recommendations for the development and validation of criteria sets. Results The highest ranked candidate criteria considered absolute changes (Δ) of the SLEDAI or BILAG, MD-global, P/C ratio, and ESR; Flare scores can be calculated [0.5 × ΔSLEDAI + 0.45 × ΔP/C ratio + 0.5 × ΔMD-global + 0.02 × ΔESR], where values ≥ 1.04 are reflective of a flare. Similarly, BILAG-based flare scores [0.4 × ΔBILAG + 0.65 × ΔP/C ratio + 0.5 × ΔMD-global + 0.02 × ΔESR] of ≥ 1.15 were diagnostic of a flare. Flare scores increase with flare severity. Conclusions Consensus has been reached on preliminary criteria for global flares in cSLE. Further validation studies are needed to confirm the usefulness of the cSLE flare criteria in research and for clinical care. PMID:21618452

Development and psychometric validation of a self-administered questionnaire assessing the acceptance of influenza vaccination: the Vaccinees' Perception of Injection (VAPI©) questionnaire

PubMed Central

Chevat, Catherine; Viala-Danten, Muriel; Dias-Barbosa, Carla; Nguyen, Van Hung

2009-01-01

Background Influenza is among the most common infectious diseases. The main protection against influenza is vaccination. A self-administered questionnaire was developed and validated for use in clinical trials to assess subjects' perception and acceptance of influenza vaccination and its subsequent injection site reactions (ISR). Methods The VAPI questionnaire was developed based on interviews with vaccinees. The initial version was administered to subjects in international clinical trials comparing intradermal with intramuscular influenza vaccination. Item reduction and scale construction were carried out using principal component and multitrait analyses (n = 549). Psychometric validation of the final version was conducted per country (n = 5,543) and included construct and clinical validity and internal consistency reliability. All subjects gave their written informed consent before being interviewed or included in the clinical studies. Results The final questionnaire comprised 4 dimensions ("bother from ISR"; "arm movement"; "sleep"; "acceptability") grouping 16 items, and 5 individual items (anxiety before vaccination; bother from pain during vaccination; satisfaction with injection system; willingness to be vaccinated next year; anxiety about vaccination next year). Construct validity was confirmed for all scales in most of the countries. Internal consistency reliability was good for all versions (Cronbach's alpha ranging from 0.68 to 0.94), as was clinical validity: scores were positively correlated with the severity of ISR and pain. Conclusion The VAPI questionnaire is a valid and reliable tool, assessing the acceptance of vaccine injection and reactions following vaccination. Trial registration NCT00258934, NCT00383526, NCT00383539. PMID:19261173

Reliability and validity of Kano Test for Social Nicotine Dependence (KTSND), and development of its revised scale assessing the psychosocial acceptability of smoking among university students.

PubMed

Kitada, Masako; Musashi, Manabu; Kano, Masato

2011-08-01

To examine reliability and validity of Kano Test for Social Nicotine Dependence (KTSND), a scale assessing the psychosocial acceptability of smoking, and to develop a new version when validity or reliability of KTSND was not acceptable. We carried out a self-administered cross-sectional survey on undergraduate university students. The participants completed the KTSND, and supplemented three questions on the attitudes toward tobacco control policies and smoking states. Using daily smokers, we examined the relationship between the KTSND and Fagerström Test for Nicotine Dependence (FTND). In each study, we examined test-retest reliability and construct validity, discriminant and convergent validity, and factor validity. Although the KTSND had high internal consistency (Cronbach's a 0.82) and high test-retest reliability (r=0.72), the results of factor analysis were unacceptable; we expected three factors to be extracted, however, only two factors of "Overestimate of smoking usefulness" and "Allege smoking as a taste and/or culture" were extracted. Using the Kano's Test for Assessing Acceptability of Smoking (KTAAS), the new version of KTSND in which a question was replaced with another one, the third factor of "Neglect of harm of tobacco smoking" was extracted adding to the above-mentioned two. KTAAS had also both high internal consistency (Cronbach's alpha 0.82) and test-retest reliability (r=0.66). Overall, the KTSND and the KTAAS score differed according to smoking states, and the nonsmokers' scores were the lowest. The KTSND was a popular questionnaire in Japan, however, its validity assessed using factor analysis was not acceptable, while KTAAS had sufficient reliability and validity, and might assess the cognition and attitude affirming or accepting tobacco smoking among university students.

Incremental Validity and Informant Effect from a Multi-Method Perspective: Assessing Relations between Parental Acceptance and Children's Behavioral Problems.

PubMed

Izquierdo-Sotorrío, Eva; Holgado-Tello, Francisco P; Carrasco, Miguel Á

2016-01-01

This study examines the relationships between perceived parental acceptance and children's behavioral problems (externalizing and internalizing) from a multi-informant perspective. Using mothers, fathers, and children as sources of information, we explore the informant effect and incremental validity. The sample was composed of 681 participants (227 children, 227 fathers, and 227 mothers). Children's (40% boys) ages ranged from 9 to 17 years (M = 12.52, SD = 1.81). Parents and children completed both the Parental Acceptance Rejection/Control Questionnaire (PARQ/Control) and the check list of the Achenbach System of Empirically Based Assessment (ASEBA). Statistical analyses were based on the correlated uniqueness multitrait-multimethod matrix (model MTMM) by structural equations and different hierarchical regression analyses. Results showed a significant informant effect and a different incremental validity related to which combination of sources was considered. A multi-informant perspective rather than a single one increased the predictive value. Our results suggest that mother-father or child-father combinations seem to be the best way to optimize the multi-informant method in order to predict children's behavioral problems based on perceived parental acceptance.

Monitoring Reading Behavior: Criteria for Performance.

ERIC Educational Resources Information Center

Powell, William R.

Effective use of the informal reading inventory (IRI) depends upon the criteria used in determining the functional reading levels and more specifically the word recognition criteria employed in describing acceptable limits of oral reading behavior. The author of this paper looks at the diverse sets of criteria commonly used, the problems…

[Validity, reliability, and acceptability of the scale of knowledge, attitude, and behavior of lifestyle intervention in a diabetes high-risk population].

PubMed

Wang, W J; Dong, J; Ren, Z P; Chen, B; He, W; Li, W D; Hao, Z W

2016-07-06

To evaluate the validity, reliability, and acceptability of the scale of knowledge, attitude, and behavior of lifestyle intervention in a diabetes high-risk population (HILKAB), and provide scientific evidence for its usage. By convenient sampling, we selected 406 individuals at high risk for diabetes for survey using the HILKAB. Pearson correlation coefficient, factor analysis, independent sampling, and t-test for high- and low-score groups were used to evaluate the content validity, construct validity, and discriminant validity of the scale. Reliability of the scale was evaluated by internal consistency, which included Cronbach's α coefficient, θ coefficient, Ω coefficient, and split-half reliability. Scale acceptability was evaluated by acceptance rate and completion time of the survey. In this study, 366 questionnaires (90.1%) was qnalified and the completion time was (8.62±2.79) minutes. Scores for knowledge, attitude, and behavior were 10.60±3.73, 26.56±3.58, 17.09±9.74, respectively. The scale had good face validity and content validity. The correlation coefficient of items and the dimension to which they belong was between 0.25 and 0.97, and the correlation coefficient of three dimensions and the entire scale was between 0.64 and 0.91, all with P<0.001. Factor analysis of the scale extracted eight common factors. The cumulative variance contribution rate was 65.23%, thereby reaching the 50% approved standard. Of 30 items there were 29 items with factor loadings ≥0.40, indicating the scale had good construct validity. For the high-score group, scores for knowledge, attitude, and behavior dimensions were 13.89±2.55, 29.56± 2.46, 28.05 ± 2.93, respectively, which were higher than those for the low-score group (7.67 ± 2.78, 23.89 ± 3.35, 6.25 ± 3.13); t-values were 55.14, 119.40, 95.29, respectively, with P<0.001. The scale consisted of three dimensions: knowledge, attitude, and behavior. The Cronbach's α coefficient was between 0.84 and 0

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

PubMed

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.

Comparative assessment of bioanalytical method validation guidelines for pharmaceutical industry.

PubMed

Kadian, Naveen; Raju, Kanumuri Siva Rama; Rashid, Mamunur; Malik, Mohd Yaseen; Taneja, Isha; Wahajuddin, Muhammad

2016-07-15

The concepts, importance, and application of bioanalytical method validation have been discussed for a long time and validation of bioanalytical methods is widely accepted as pivotal before they are taken into routine use. United States Food and Drug Administration (USFDA) guidelines issued in 2001 have been referred for every guideline released ever since; may it be European Medical Agency (EMA) Europe, National Health Surveillance Agency (ANVISA) Brazil, Ministry of Health and Labour Welfare (MHLW) Japan or any other guideline in reference to bioanalytical method validation. After 12 years, USFDA released its new draft guideline for comments in 2013, which covers the latest parameters or topics encountered in bioanalytical method validation and approached towards the harmonization of bioanalytical method validation across the globe. Even though the regulatory agencies have general agreement, significant variations exist in acceptance criteria and methodology. The present review highlights the variations, similarities and comparison between bioanalytical method validation guidelines issued by major regulatory authorities worldwide. Additionally, other evaluation parameters such as matrix effect, incurred sample reanalysis including other stability aspects have been discussed to provide an ease of access for designing a bioanalytical method and its validation complying with the majority of drug authority guidelines. Copyright © 2016. Published by Elsevier B.V.

Validity of response assessment criteria in neoadjuvant chemotherapy for gastric cancer (JCOG0507-A).

PubMed

Kurokawa, Yukinori; Shibata, Taro; Sasako, Mitsuru; Sano, Takeshi; Tsuburaya, Akira; Iwasaki, Yoshiaki; Fukuda, Haruhiko

2014-01-01

Neoadjuvant chemotherapy may improve outcomes in gastric cancer. Tumor responses can be evaluated with RECIST, Japanese Classification of Gastric Carcinoma (JCGC), and histological criteria. These approaches have not yet been compared. We analyzed two phase II trials of neoadjuvant chemotherapy using S-1 plus cisplatin. JCOG0210 included patients with linitis plastica and large ulcero-invasive tumors, whereas JCOG0405 comprised those with para-aortic or bulky lymph node metastases. Radiologic evaluations were conducted using RECIST in JCOG0405 and JCGC criteria in JCOG0210, because the latter included many patients without measurable lesions. A histological responder was defined as a patient in whom one third or more of the tumor was affected. The hazard ratios (HR) for death between responders and non-responders and response rate differences between short- and long-term survivors were estimated. In JCOG0210 (n = 49), HR was 0.54 in JCGC responders (P = 0.059) and 0.40 in histological responders (P = 0.005). The difference in response rates between short- and long-term survivors using histological criteria (34 %, P = 0.023) was greater than that using JCGC criteria (24 %, P = 0.15). In JCOG0405 (n = 51), HR was 0.67 in RECIST responders (P = 0.35) and 0.39 in histological responders (P = 0.030). In short- and long-term survivors, respectively, RECIST response rates were 62  and 67 % (P = 0.77), whereas histological response rates were 33  and 63 % (P = 0.048). Histological criteria showed higher response assessment validity than RECIST or JCGC criteria and yielded the best surrogate endpoint for overall survival.

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

PubMed

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.

Preliminary criteria for global flares in childhood-onset systemic lupus erythematosus.

PubMed

Brunner, Hermine I; Mina, Rina; Pilkington, Clarissa; Beresford, Michael W; Reiff, Andreas; Levy, Deborah M; Tucker, Lori B; Eberhard, B Anne; Ravelli, Angelo; Schanberg, Laura E; Saad-Magalhaes, Claudia; Higgins, Gloria C; Onel, Karen; Singer, Nora G; von Scheven, Emily; Itert, Lukasz; Klein-Gitelman, Marisa S; Punaro, Marilynn; Ying, Jun; Giannini, Edward H

2011-09-01

To develop widely acceptable preliminary criteria of global flare for childhood-onset systemic lupus erythematosus (cSLE). Pediatric rheumatologists (n = 138) rated a total of 358 unique patient profiles with information about the cSLE flare descriptors from 2 consecutive visits: patient global assessment of well-being, physician global assessment of disease activity (MD-global), health-related quality of life, anti-double-stranded DNA antibodies, disease activity index scores, protein:creatinine (P:C) ratio, complement levels, and erythrocyte sedimentation rate (ESR). Based on 2,996 rater responses about the course of cSLE (baseline versus followup), the accuracy (sensitivity, specificity, and area under the receiver operating characteristic curve) of candidate flare criteria was assessed. An international consensus conference was held to rank these candidate flare criteria as per the American College of Rheumatology recommendations for the development and validation of criteria sets. The highest-ranked candidate criteria considered absolute changes (Δ) of the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) or British Isles Lupus Assessment Group (BILAG), MD-global, P:C ratio, and ESR; flare scores can be calculated (0.5 × ΔSLEDAI + 0.45 × ΔP:C ratio + 0.5 × ΔMD-global + 0.02 × ΔESR), where values of ≥1.04 are reflective of a flare. Similarly, BILAG-based flare scores (0.4 × ΔBILAG + 0.65 × ΔP:C ratio + 0.5 × ΔMD-global + 0.02 × ΔESR) of ≥1.15 were diagnostic of a flare. Flare scores increased with flare severity. Consensus has been reached on preliminary criteria for global flares in cSLE. Further validation studies are needed to confirm the usefulness of the cSLE flare criteria in research and for clinical care. Copyright © 2011 by the American College of Rheumatology.

Development and Validation of Mobile Learning Acceptance Measure

ERIC Educational Resources Information Center

Sharma, Sujeet Kumar; Sarrab, Mohamed; Al-Shihi, Hafedh

2017-01-01

The growth of Smartphone usage, increased acceptance of electronic learning (E-learning), the availability of high reliability mobile networks and need for flexibility in learning have resulted in the growth of mobile learning (M-learning). This has led to a tremendous interest in the acceptance behaviors related to M-learning users among the…

Validity and Acceptance of Color Vision Testing on Smartphones.

PubMed

Ozgur, Omar K; Emborgo, Trisha S; Vieyra, Mark B; Huselid, Rebecca F; Banik, Rudrani

2018-03-01

Ishihara color plates (ICP) are the most commonly used color vision test (CVT) worldwide. With the advent of new technologies, attempts have been made to streamline the process of CVT. As hardware and software evolve, smartphone-based testing modalities may aid ophthalmologists in performing more efficient ophthalmic examinations. We assess the validity of smartphone color vision testing (CVT) by comparing results using the Eye Handbook (EHB) CVT application with standard Ishihara color plates (ICP). Prospective case-control study of subjects 18 years and older with visual acuity of 20/100 or better at 14 inches. The study group included patients with any ocular pathology. The color vision deficient (CVD) group was patients who failed more than 2 plates. The control group had no known ocular pathology. CVT was performed with both ICP and EHB under standardized background illuminance. Eleven plates were tested with each modality. Validity of EHB CVT and acceptance of EHB CVT were analyzed. Statistical analyses were performed using Bland-Altman plot with limits of agreement (LOA) at the 95th percentile of differences in score, independent samples t tests with 95% confidence interval (CI), and Pearson χ tests. The Bland-Altman plot showed agreement between correct number of plates in EHB and ICP for the study subjects (bias, -0.25; LOA, -1.92 to 1.42). Agreement was also observed between the correct number of plates in EHB and ICP for the controls (bias, -0.01; LOA, -0.61 to 0.59) and CVD (bias, -0.50; LOA, -4.64 to 3.64) subjects. The sensitivity of EHB was 0.92 (95% CI 0.76-1.07) and the specificity of EHB was 1.00 (95% CI 1.00-1.00). Fifty-nine percent preferred EHB, 12% preferred ICP, and 29% had no preference. In healthy controls and patients with ocular pathology, there was an agreement of CVT results comparing EHB with ICP. Overall, the majority preferred EHB to ICP. These findings demonstrate that further testing is required to understand and improve the

Unresectable Hepatocellular Carcinoma: MR Imaging after Intraarterial Therapy. Part I. Identification and Validation of Volumetric Functional Response Criteria

PubMed Central

Bonekamp, Susanne; Li, Zhen; Geschwind, Jean-François H.; Halappa, Vivek Gowdra; Corona-Villalobos, Celia Pamela; Reyes, Diane; Pawlik, Timothy M.; Bonekamp, David; Eng, John

2013-01-01

Purpose: To identify and validate the optimal thresholds for volumetric functional MR imaging response criteria to predict overall survival after intraarterial treatment (IAT) in patients with unresectable hepatocellular carcinoma (HCC). Materials and Methods: Institutional review board approval and waiver of informed consent were obtained. A total of 143 patients who had undergone MR imaging before and 3–4 weeks after the first cycle of IAT were included. MR imaging analysis of one representative HCC index lesion was performed with proprietary software after initial treatment. Subjects were randomly divided into training (n = 114 [79.7%]) and validation (n = 29 [20.3%]) data sets. Uni- and multivariate Cox models were used to determine the best cutoffs, as well as survival differences, between response groups in the validation data set. Results: Optimal cutoffs in the training data set were 23% increase in apparent diffusion coefficient (ADC) and 65% decrease in volumetric enhancement in the portal venous phase (VE). Subsequently, 25% increase in ADC and 65% decrease in VE were used to stratify patients in the validation data set. Comparison of ADC responders (n = 12 [58.6%]) with nonresponders (n = 17 [34.5%]) showed significant differences in survival (25th percentile survival, 11.2 vs 4.9 months, respectively; P = .008), as did VE responders (n = 9 [31.0%]) compared with nonresponders (n = 20 [69.0%]; 25th percentile survival, 11.5 vs 5.1 months, respectively; P = .01). Stratification of patients with a combination of the criteria resulted in significant differences in survival between patients with lesions that fulfilled both criteria (n = 6 [20.7%]; too few cases to determine 25th percentile), one criterion (n = 9 [31.0%]; 25th percentile survival, 6.0 months), and neither criterion (n = 14 [48.3%]; 25th percentile survival, 5.1 months; P = .01). The association between the two criteria and overall survival remained significant in a multivariate analysis

Acceptability of willingness to pay techniques to consumers.

PubMed

Taylor, Susan J; Armour, Carol L

2002-12-01

The purpose of this study was to assess and compare the proportion of usable responses and protest votes obtained with two willingness to pay (WTP) techniques, contingent valuation (CV) and discrete choice experiment (DCE) and to assess the acceptability of the techniques to respondents. Pregnant women attending the public antenatal clinics of a Sydney teaching hospital were surveyed. Preference for either Treatment A (artificial rupture of the membranes followed by intravenous oxytocin) or Treatment B (prostaglandin E2 gel followed by oxytocin if necessary) was assessed. Then WTP for the preferred treatments was assessed using CV and WTP for specific attributes of the treatments in the DCE. In addition, the acceptability of the two techniques was compared in terms of responses deemed to be valid according to defined criteria, protest votes and comments recorded by consumers. With the CV, 74% of respondents chose gel and their maximum WTP was Aus$178 compared with $133 for the alternative. A total of 68% of responses were deemed to be valid including 5% who may have been expressing a protest vote. With the DCE, respondents were WTP $55 for every 1 h reduction in the length of time from induction to delivery. A total of 72% of responses were deemed valid and only two of these 258 women were considered to have expressed a protest vote. Only a small number of women expressed objections to the use of WTP questions in health-care and the majority of women completed both questions successfully.

Acceptability of willingness to pay techniques to consumers

PubMed Central

Taylor, Susan J.; Armour, Carol L.

2002-01-01

Abstract Objective The purpose of this study was to assess and compare the proportion of usable responses and protest votes obtained with two willingness to pay (WTP) techniques, contingent valuation (CV) and discrete choice experiment (DCE) and to assess the acceptability of the techniques to respondents. Setting and participants Pregnant women attending the public antenatal clinics of a Sydney teaching hospital were surveyed. Main variables studied Preference for either Treatment A (artificial rupture of the membranes followed by intravenous oxytocin) or Treatment B (prostaglandin E2 gel followed by oxytocin if necessary) was assessed. Then WTP for the preferred treatments was assessed using CV and WTP for specific attributes of the treatments in the DCE. In addition, the acceptability of the two techniques was compared in terms of responses deemed to be valid according to defined criteria, protest votes and comments recorded by consumers. Results With the CV, 74% of respondents chose gel and their maximum WTP was Aus$178 compared with $133 for the alternative. A total of 68% of responses were deemed to be valid including 5% who may have been expressing a protest vote. With the DCE, respondents were WTP $55 for every 1 h reduction in the length of time from induction to delivery. A total of 72% of responses were deemed valid and only two of these 258 women were considered to have expressed a protest vote. Conclusions Only a small number of women expressed objections to the use of WTP questions in health‐care and the majority of women completed both questions successfully. PMID:12460223

The 2002 NIMH Provisional Diagnostic Criteria for Depression of Alzheimer's Disease (PDC-dAD): Gauging their Validity over a Decade Later.

PubMed

Sepehry, Amir A; Lee, Philip E; Hsiung, Ging-Yuek R; Beattie, B Lynn; Feldman, Howard H; Jacova, Claudia

2017-01-01

Presented herein is evidence for criterion, content, and convergent/discriminant validity of the NIMH-Provisional Diagnostic Criteria for depression of Alzheimer's Disease (PDC-dAD) that were formulated to address depression in Alzheimer's disease (AD). Using meta-analytic and systematic review methods, we examined criterion validity evidence in epidemiological and clinical studies comparing the PDC-dAD to Diagnostic and Statistical Manual of Mental Disorders fourth edition (DSM-IV), and International Classification of Disease (ICD 9) depression diagnostic criteria. We estimated prevalence of depression by PDC, DSM, and ICD with an omnibus event rate effect-size. We also examined diagnostic agreement between PDC and DSM. To gauge content validity, we reviewed rates of symptom endorsement for each diagnostic approach. Finally, we examined the PDC's relationship with assessment scales (global cognition, neuropsychiatric, and depression definition) for convergent validity evidence. The aggregate evidence supports the validity of the PDC-dAD. Our findings suggest that depression in AD differs from other depressive disorders including Major Depressive Disorder (MDD) in that dAD is more prevalent, with generally a milder presentation and with unique features not captured by the DSM. Although the PDC are the current standard for diagnosis of depression in AD, we identified the need for their further optimization based on predictive validity evidence.

Validation of the 2010 American College of Rheumatology preliminary diagnostic criteria for fibromyalgia in an Iranian population.

PubMed

Bidari, Ali; Hassanzadeh, Morteza; Ghavidel Parsa, Banafsheh; Kianmehr, Nahid; Kabir, Ali; Pirhadi, Sara; Sayfi, Mohammad; Toutounchi, Mehrangiz; Fattahi, Fariba; Zandi Karimi, Fereidoon

2013-12-01

The aim of this study was to validate the 2010 American College of Rheumatology (ACR) preliminary criteria for fibromyalgia (FM) in an Iranian population. In this multicenter prospective study, we enrolled 168 FM patients and 110 controls. All participants underwent dolorimetry examination by study assessors and completed a questionnaire containing variables of both the ACR 2010 preliminary and ACR 1990 criteria. We compared the performance of the ACR 2010 criteria with the expert diagnosis as well as the ACR 1990 criteria. Receiver operator characteristic analyses and Youden index were used to evaluate the test characteristics of a set of different cutoff points for two subcomponents of ACR 2010 criteria including widespread pain index (WPI) and symptom severity (SS) scale. Considering expert diagnosis as the gold standard, the ACR 2010 criteria showed comparable specificity with ACR 1990 (92.8 vs. 88.3 %, P = 0.073), but lower sensitivity (58.9 vs. 71.4 %, P = 0.003) and a tendency for lower accuracy (72.4 vs. 78.4 %, P = 0.105). Applying the ACR 1990 criteria as the gold standard, we observed a trend toward an increase in overall accuracy (72.4 vs. 79.1 %, P = 0.064). Optimal test characteristics were achieved for WPI ≥6 and SS scale score ≥4 and improved sensitivity and accuracy of ACR 2010 criteria when compared to expert, 76.1 and 81.7, respectively. The preliminary ACR 2010 criteria performed less desirably in terms of sensitivity in our set of Iranian patients. Selecting lower cutoff points as WPI ≥6 and SS scale score ≥4 improved the diagnostic values of the criteria.

Alternative microbial methods: An overview and selection criteria.

PubMed

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.

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

PubMed

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.

Assessment of the Validity of the Research Diagnostic Criteria for Temporomandibular Disorders: Overview and Methodology

PubMed Central

Schiffman, Eric L.; Truelove, Edmond L.; Ohrbach, Richard; Anderson, Gary C.; John, Mike T.; List, Thomas; Look, John O.

2011-01-01

AIMS The purpose of the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) Validation Project was to assess the diagnostic validity of this examination protocol. An overview is presented, including Axis I and II methodology and descriptive statistics for the study participant sample. This paper details the development of reliable methods to establish the reference standards for assessing criterion validity of the Axis I RDC/TMD diagnoses. Validity testing for the Axis II biobehavioral instruments was based on previously validated reference standards. METHODS The Axis I reference standards were based on the consensus of 2 criterion examiners independently performing a comprehensive history, clinical examination, and evaluation of imaging. Intersite reliability was assessed annually for criterion examiners and radiologists. Criterion exam reliability was also assessed within study sites. RESULTS Study participant demographics were comparable to those of participants in previous studies using the RDC/TMD. Diagnostic agreement of the criterion examiners with each other and with the consensus-based reference standards was excellent with all kappas ≥ 0.81, except for osteoarthrosis (moderate agreement, k = 0.53). Intrasite criterion exam agreement with reference standards was excellent (k ≥ 0.95). Intersite reliability of the radiologists for detecting computed tomography-disclosed osteoarthrosis and magnetic resonance imaging-disclosed disc displacement was good to excellent (k = 0.71 and 0.84, respectively). CONCLUSION The Validation Project study population was appropriate for assessing the reliability and validity of the RDC/TMD Axis I and II. The reference standards used to assess the validity of Axis I TMD were based on reliable and clinically credible methods. PMID:20213028

2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria.

PubMed

Wolfe, Frederick; Clauw, Daniel J; Fitzcharles, Mary-Ann; Goldenberg, Don L; Häuser, Winfried; Katz, Robert L; Mease, Philip J; Russell, Anthony S; Russell, Irwin Jon; Walitt, Brian

2016-12-01

The provisional criteria of the American College of Rheumatology (ACR) 2010 and the 2011 self-report modification for survey and clinical research are widely used for fibromyalgia diagnosis. To determine the validity, usefulness, potential problems, and modifications required for the criteria, we assessed multiple research reports published in 2010-2016 in order to provide a 2016 update to the criteria. We reviewed 14 validation studies that compared 2010/2011 criteria with ACR 1990 classification and clinical criteria, as well as epidemiology, clinical, and databank studies that addressed important criteria-level variables. Based on definitional differences between 1990 and 2010/2011 criteria, we interpreted 85% sensitivity and 90% specificity as excellent agreement. Against 1990 and clinical criteria, the median sensitivity and specificity of the 2010/2011 criteria were 86% and 90%, respectively. The 2010/2011 criteria led to misclassification when applied to regional pain syndromes, but when a modified widespread pain criterion (the "generalized pain criterion") was added misclassification was eliminated. Based on the above data and clinic usage data, we developed a (2016) revision to the 2010/2011 fibromyalgia criteria. Fibromyalgia may now be diagnosed in adults when all of the following criteria are met: CONCLUSIONS: The fibromyalgia criteria have good sensitivity and specificity. This revision combines physician and questionnaire criteria, minimizes misclassification of regional pain disorders, and eliminates the previously confusing recommendation regarding diagnostic exclusions. The physician-based criteria are valid for individual patient diagnosis. The self-report version of the criteria is not valid for clinical diagnosis in individual patients but is valid for research studies. These changes allow the criteria to function as diagnostic criteria, while still being useful for classification. Copyright © 2016 Elsevier Inc. All rights reserved.

Validating the Technology Acceptance Model in the Context of the Laboratory Information System-Electronic Health Record Interface System

ERIC Educational Resources Information Center

Aquino, Cesar A.

2014-01-01

This study represents a research validating the efficacy of Davis' Technology Acceptance Model (TAM) by pairing it with the Organizational Change Readiness Theory (OCRT) to develop another extension to the TAM, using the medical Laboratory Information Systems (LIS)--Electronic Health Records (EHR) interface as the medium. The TAM posits that it is…

Groundwater Model Validation

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

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 ofmore » 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 of the Chronic Pain Acceptance Questionnaire-8 in an Australian pain clinic sample.

PubMed

Baranoff, John; Hanrahan, Stephanie J; Kapur, Dilip; Connor, Jason P

2014-02-01

Recently, an 8-item short-form version of the Chronic Pain Acceptance Questionnaire (CPAQ-8) was developed predominantly in an internet sample. Further investigation of the factor structure in a multidisciplinary pain clinic sample is required. Investigation of the concurrent validity of the CPAQ-8 after accounting for the effects of variables commonly measured in the pain clinic setting is also necessary. This study examines the factor structure and concurrent validity of the CPAQ-8 in a sample of treatment-seeking patients who attended a multidisciplinary pain clinic. Participants were 334 patients who attended an Australian multidisciplinary pain service. Participants completed the CPAQ, a demographic questionnaire, and measures of patient adjustment and functioning. Confirmatory factor analysis identified a two-factor 8-item model consisting of Activity Engagement and Pain Willingness factors (SRMR = 0.039, RMSEA = 0.063, CFI = 0.973, TLI = 0.960) was superior to both the CPAQ and CPAQ with an item removed. The CPAQ and CPAQ-8 total scores were highly correlated (r = 0.93). After accounting for pain intensity, the CPAQ-8 was a significant predictor of depression, anxiety, stress, and disability. The subscales of the CPAQ-8 were both unique contributors to depression and disability in regression analyses, after accounting for pain intensity and kinesiophobia, and after accounting for pain intensity and catastrophizing. The CPAQ-8 has a sound factor structure and similar psychometric properties to the CPAQ; it may have clinical utility as a measure of pain acceptance in treatment-seeking, chronic pain patients.

Reliability, Validity, and Classification Accuracy of the DSM-5 Diagnostic Criteria for Gambling Disorder and Comparison to DSM-IV.

PubMed

Stinchfield, Randy; McCready, John; Turner, Nigel E; Jimenez-Murcia, Susana; Petry, Nancy M; Grant, Jon; Welte, John; Chapman, Heather; Winters, Ken C

2016-09-01

The DSM-5 was published in 2013 and it included two substantive revisions for gambling disorder (GD). These changes are the reduction in the threshold from five to four criteria and elimination of the illegal activities criterion. The purpose of this study was to twofold. First, to assess the reliability, validity and classification accuracy of the DSM-5 diagnostic criteria for GD. Second, to compare the DSM-5-DSM-IV on reliability, validity, and classification accuracy, including an examination of the effect of the elimination of the illegal acts criterion on diagnostic accuracy. To compare DSM-5 and DSM-IV, eight datasets from three different countries (Canada, USA, and Spain; total N = 3247) were used. All datasets were based on similar research methods. Participants were recruited from outpatient gambling treatment services to represent the group with a GD and from the community to represent the group without a GD. All participants were administered a standardized measure of diagnostic criteria. The DSM-5 yielded satisfactory reliability, validity and classification accuracy. In comparing the DSM-5 to the DSM-IV, most comparisons of reliability, validity and classification accuracy showed more similarities than differences. There was evidence of modest improvements in classification accuracy for DSM-5 over DSM-IV, particularly in reduction of false negative errors. This reduction in false negative errors was largely a function of lowering the cut score from five to four and this revision is an improvement over DSM-IV. From a statistical standpoint, eliminating the illegal acts criterion did not make a significant impact on diagnostic accuracy. From a clinical standpoint, illegal acts can still be addressed in the context of the DSM-5 criterion of lying to others.

Several submaximal exercise tests are reliable, valid and acceptable in people with chronic pain, fibromyalgia or chronic fatigue: a systematic review.

PubMed

Ratter, Julia; Radlinger, Lorenz; Lucas, Cees

2014-09-01

Are submaximal and maximal exercise tests reliable, valid and acceptable in people with chronic pain, fibromyalgia and fatigue disorders? Systematic review of studies of the psychometric properties of exercise tests. People older than 18 years with chronic pain, fibromyalgia and chronic fatigue disorders. Studies of the measurement properties of tests of physical capacity in people with chronic pain, fibromyalgia or chronic fatigue disorders were included. Studies were required to report: reliability coefficients (intraclass correlation coefficient, alpha reliability coefficient, limits of agreements and Bland-Altman plots); validity coefficients (intraclass correlation coefficient, Spearman's correlation, Kendal T coefficient, Pearson's correlation); or dropout rates. Fourteen studies were eligible: none had low risk of bias, 10 had unclear risk of bias and four had high risk of bias. The included studies evaluated: Åstrand test; modified Åstrand test; Lean body mass-based Åstrand test; submaximal bicycle ergometer test following another protocol other than Åstrand test; 2-km walk test; 5-minute, 6-minute and 10-minute walk tests; shuttle walk test; and modified symptom-limited Bruce treadmill test. None of the studies assessed maximal exercise tests. Where they had been tested, reliability and validity were generally high. Dropout rates were generally acceptable. The 2-km walk test was not recommended in fibromyalgia. Moderate evidence was found for reliability, validity and acceptability of submaximal exercise tests in patients with chronic pain, fibromyalgia or chronic fatigue. There is no evidence about maximal exercise tests in patients with chronic pain, fibromyalgia and chronic fatigue. Copyright © 2014. Published by Elsevier B.V.

Validating new diagnostic imaging criteria for primary progressive aphasia via anatomical likelihood estimation meta-analyses.

PubMed

Bisenius, S; Neumann, J; Schroeter, M L

2016-04-01

Recently, diagnostic clinical and imaging criteria for primary progressive aphasia (PPA) have been revised by an international consortium (Gorno-Tempini et al. Neurology 2011;76:1006-14). The aim of this study was to validate the specificity of the new imaging criteria and investigate whether different imaging modalities [magnetic resonance imaging (MRI) and fluorodeoxyglucose positron emission tomography (FDG-PET)] require different diagnostic subtype-specific imaging criteria. Anatomical likelihood estimation meta-analyses were conducted for PPA subtypes across a large cohort of 396 patients: firstly, across MRI studies for each of the three PPA subtypes followed by conjunction and subtraction analyses to investigate the specificity, and, secondly, by comparing results across MRI vs. FDG-PET studies in semantic dementia and progressive nonfluent aphasia. Semantic dementia showed atrophy in temporal, fusiform, parahippocampal gyri, hippocampus, and amygdala, progressive nonfluent aphasia in left putamen, insula, middle/superior temporal, precentral, and frontal gyri, logopenic progressive aphasia in middle/superior temporal, supramarginal, and dorsal posterior cingulate gyri. Results of the disease-specific meta-analyses across MRI studies were disjunct. Similarly, atrophic and hypometabolic brain networks were regionally dissociated in both semantic dementia and progressive nonfluent aphasia. In conclusion, meta-analyses support the specificity of new diagnostic imaging criteria for PPA and suggest that they should be specified for each imaging modality separately. © 2016 EAN.

MRI-based modeling for radiocarpal joint mechanics: validation criteria and results for four specimen-specific models.

PubMed

Fischer, Kenneth J; Johnson, Joshua E; Waller, Alexander J; McIff, Terence E; Toby, E Bruce; Bilgen, Mehmet

2011-10-01

The objective of this study was to validate the MRI-based joint contact modeling methodology in the radiocarpal joints by comparison of model results with invasive specimen-specific radiocarpal contact measurements from four cadaver experiments. We used a single validation criterion for multiple outcome measures to characterize the utility and overall validity of the modeling approach. For each experiment, a Pressurex film and a Tekscan sensor were sequentially placed into the radiocarpal joints during simulated grasp. Computer models were constructed based on MRI visualization of the cadaver specimens without load. Images were also acquired during the loaded configuration used with the direct experimental measurements. Geometric surface models of the radius, scaphoid and lunate (including cartilage) were constructed from the images acquired without the load. The carpal bone motions from the unloaded state to the loaded state were determined using a series of 3D image registrations. Cartilage thickness was assumed uniform at 1.0 mm with an effective compressive modulus of 4 MPa. Validation was based on experimental versus model contact area, contact force, average contact pressure and peak contact pressure for the radioscaphoid and radiolunate articulations. Contact area was also measured directly from images acquired under load and compared to the experimental and model data. Qualitatively, there was good correspondence between the MRI-based model data and experimental data, with consistent relative size, shape and location of radioscaphoid and radiolunate contact regions. Quantitative data from the model generally compared well with the experimental data for all specimens. Contact area from the MRI-based model was very similar to the contact area measured directly from the images. For all outcome measures except average and peak pressures, at least two specimen models met the validation criteria with respect to experimental measurements for both articulations

Testing and validating environmental models

USGS Publications Warehouse

Kirchner, J.W.; Hooper, R.P.; Kendall, C.; Neal, C.; Leavesley, G.

1996-01-01

Generally accepted standards for testing and validating ecosystem models would benefit both modellers and model users. Universally applicable test procedures are difficult to prescribe, given the diversity of modelling approaches and the many uses for models. However, the generally accepted scientific principles of documentation and disclosure provide a useful framework for devising general standards for model evaluation. Adequately documenting model tests requires explicit performance criteria, and explicit benchmarks against which model performance is compared. A model's validity, reliability, and accuracy can be most meaningfully judged by explicit comparison against the available alternatives. In contrast, current practice is often characterized by vague, subjective claims that model predictions show 'acceptable' agreement with data; such claims provide little basis for choosing among alternative models. Strict model tests (those that invalid models are unlikely to pass) are the only ones capable of convincing rational skeptics that a model is probably valid. However, 'false positive' rates as low as 10% can substantially erode the power of validation tests, making them insufficiently strict to convince rational skeptics. Validation tests are often undermined by excessive parameter calibration and overuse of ad hoc model features. Tests are often also divorced from the conditions under which a model will be used, particularly when it is designed to forecast beyond the range of historical experience. In such situations, data from laboratory and field manipulation experiments can provide particularly effective tests, because one can create experimental conditions quite different from historical data, and because experimental data can provide a more precisely defined 'target' for the model to hit. We present a simple demonstration showing that the two most common methods for comparing model predictions to environmental time series (plotting model time series

Incremental Validity and Informant Effect from a Multi-Method Perspective: Assessing Relations between Parental Acceptance and Children’s Behavioral Problems

PubMed Central

Izquierdo-Sotorrío, Eva; Holgado-Tello, Francisco P.; Carrasco, Miguel Á.

2016-01-01

This study examines the relationships between perceived parental acceptance and children’s behavioral problems (externalizing and internalizing) from a multi-informant perspective. Using mothers, fathers, and children as sources of information, we explore the informant effect and incremental validity. The sample was composed of 681 participants (227 children, 227 fathers, and 227 mothers). Children’s (40% boys) ages ranged from 9 to 17 years (M = 12.52, SD = 1.81). Parents and children completed both the Parental Acceptance Rejection/Control Questionnaire (PARQ/Control) and the check list of the Achenbach System of Empirically Based Assessment (ASEBA). Statistical analyses were based on the correlated uniqueness multitrait-multimethod matrix (model MTMM) by structural equations and different hierarchical regression analyses. Results showed a significant informant effect and a different incremental validity related to which combination of sources was considered. A multi-informant perspective rather than a single one increased the predictive value. Our results suggest that mother–father or child–father combinations seem to be the best way to optimize the multi-informant method in order to predict children’s behavioral problems based on perceived parental acceptance. PMID:27242582

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

PubMed

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.

PubMed

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 (<18 years) diagnosed with GBS between 1987 and 2013 at Sophia 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.

49 CFR 173.57 - Acceptance criteria for new explosives.

Code of Federal Regulations, 2010 CFR

2010-10-01

... must be subjected to the Drop Weight Impact Sensitivity Test (Test Method 3(a)(i)), the Friction... substance has a friction sensitiveness equal to or greater than that of dry pentaerythrite tetranitrate (PETN) when tested in the Friction Sensitivity Test; (4) The substance fails to pass the test criteria...

Community-acquired bacterial pneumonia in human immunodeficiency virus-infected patients: validation of severity criteria. The Grupo Andaluz para el Estudio de las Enfermedades Infecciosas.

PubMed

Cordero, E; Pachón, J; Rivero, A; Girón, J A; Gómez-Mateos, J; Merino, M D; Torres-Tortosa, M; González-Serrano, M; Aliaga, L; Collado, A; Hernández-Quero, J; Barrera, A; Nuño, E

2000-12-01

Severity criteria for community-acquired pneumonia (CAP) have always excluded patients with human immunodeficiency virus (HIV) infection. A 1-yr, multicenter, prospective observational study of HIV-infected patients with bacterial CAP was done to validate the criteria used in the American Thoracic Society (ATS) guidelines for CAP, and to determine the prognosis-associated factors in the HIV-infected population with bacterial CAP. Overall, 355 cases were included, with an attributable mortality of 9.3%. Patients who met the ATS criteria had a longer hospital stay (p = 0.01), longer duration of fever (p < 0.001), and higher attributable mortality (13.1% versus 3.5%, p = 0.02) than those who did not. Three factors were independently related to mortality: CD4(+) cell count < 100/microl, radiologic progression of disease, and shock. Pleural effusion, cavities, and/or multilobar infiltrates at admission were independently associated with radiologic progression. A prognostic rule based on the five criteria of shock, CD4(+) cell count < 100/microl, pleural effusion, cavities, and multilobar infiltrates had a high negative predictive value for mortality (97.1%). The attributable mortality for severe pneumonia was 11.3%, as compared with 1.3% for nonsevere disease (p = 0.008). The ATS severity criteria are valid in HIV-infected patients with bacterial CAP. Our study provides the basis for identification of patients who may require hospitalization determined by clinical judgment and the five clinical criteria of shock, a CD4(+) cell count < 100/microl, pleural effusion, cavities, and multilobar involvement. These prognostic factors should be validated in independent cohort studies.

LIMS user acceptance testing.

PubMed

Klein, Corbett S

2003-01-01

Laboratory Information Management Systems (LIMS) play a key role in the pharmaceutical industry. Thorough and accurate validation of such systems is critical and is a regulatory requirement. LIMS user acceptance testing is one aspect of this testing and enables the user to make a decision to accept or reject implementation of the system. This paper discusses key elements in facilitating the development and execution of a LIMS User Acceptance Test Plan (UATP).

Development and Validation of the Controller Acceptance Rating Scale (CARS): Results of Empirical Research

NASA Technical Reports Server (NTRS)

Lee, Katharine K.; Kerns, Karol; Bone, Randall

2001-01-01

The measurement of operational acceptability is important for the development, implementation, and evolution of air traffic management decision support tools. The Controller Acceptance Rating Scale was developed at NASA Ames Research Center for the development and evaluation of the Passive Final Approach Spacing Tool. CARS was modeled after a well-known pilot evaluation rating instrument, the Cooper-Harper Scale, and has since been used in the evaluation of the User Request Evaluation Tool, developed by MITRE's Center for Advanced Aviation System Development. In this paper, we provide a discussion of the development of CARS and an analysis of the empirical data collected with CARS to examine construct validity. Results of intraclass correlations indicated statistically significant reliability for the CARS. From the subjective workload data that were collected in conjunction with the CARS, it appears that the expected set of workload attributes was correlated with the CARS. As expected, the analysis also showed that CARS was a sensitive indicator of the impact of decision support tools on controller operations. Suggestions for future CARS development and its improvement are also provided.

The Research Diagnostic Criteria for Temporomandibular Disorders. I: overview and methodology for assessment of validity.

PubMed

Schiffman, Eric L; Truelove, Edmond L; Ohrbach, Richard; Anderson, Gary C; John, Mike T; List, Thomas; Look, John O

2010-01-01

The purpose of the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) Validation Project was to assess the diagnostic validity of this examination protocol. The aim of this article is to provide an overview of the project's methodology, descriptive statistics, and data for the study participant sample. This article also details the development of reliable methods to establish the reference standards for assessing criterion validity of the Axis I RDC/TMD diagnoses. The Axis I reference standards were based on the consensus of two criterion examiners independently performing a comprehensive history, clinical examination, and evaluation of imaging. Intersite reliability was assessed annually for criterion examiners and radiologists. Criterion examination reliability was also assessed within study sites. Study participant demographics were comparable to those of participants in previous studies using the RDC/TMD. Diagnostic agreement of the criterion examiners with each other and with the consensus-based reference standards was excellent with all kappas > or = 0.81, except for osteoarthrosis (moderate agreement, k = 0.53). Intrasite criterion examiner agreement with reference standards was excellent (k > or = 0.95). Intersite reliability of the radiologists for detecting computed tomography-disclosed osteoarthrosis and magnetic resonance imaging-disclosed disc displacement was good to excellent (k = 0.71 and 0.84, respectively). The Validation Project study population was appropriate for assessing the reliability and validity of the RDC/TMD Axis I and II. The reference standards used to assess the validity of Axis I TMD were based on reliable and clinically credible methods.

Comparison and validation of International Consensus Diagnostic Criteria for diagnosis of autoimmune pancreatitis from pancreatic cancer in a Taiwanese cohort.

PubMed

Chang, Ming-Chu; Liang, Po-Chin; Jan, I-Shiow; Yang, Ching-Yao; Tien, Yu-Wen; Wei, Shu-Chen; Wong, Jau-Min; Chang, Yu-Ting

2014-08-18

The International Consensus Diagnostic Criteria (ICDC) designed to diagnosis autoimmune pancreatitis (AIP) has been proposed recently. The diagnostic performance of ICDC has not been previously evaluated in diffuse-type and focal-type AIP, respectively, in comparison with the revised HISORt and Asian criteria in Taiwan. Prospective, consecutive patient cohort. Largest tertiary referred centre hospital managing pancreatic disease in Taiwan. 188 patients with AIP and 130 with tissue proofed pancreatic adenocarcinoma were consecutively recruited. The ICDC, as well as revised HISORt and Asian criteria, was applied for each participant. Each diagnostic criterion of ICDC was validated with special reference to levels 1 and 2 in diffuse-type and focal-type AIP. Sensitivity, specificity and accuracy. Each diagnostic criterion of ICDC was validated with special reference to levels 1 and 2 in AIP and focal-type AIP. The sensitivity, specificity and accuracy of ICDC for all AIP were the best: 89.4%, 100% and 93.7%, respectively, in these three criteria. The sensitivity, specificity and accuracy of ICDC for focal-type AIP (84.9%, 100% and 93.8%) were also the best among these three criteria. The area under the curve of receiver-operator characteristic of ICDC was 0.95 (95% CI 0.92 to 0.97) in all AIP and 0.93 (95% CI 0.88 to 0.97) in focal-type AIP. The sensitivity, specificity and accuracy of ICDC are higher than the revised HISORt and Asian criteria. The sensitivity, specificity and accuracy of each criterion are higher in diffuse-type AIP compared with focal-type AIP. Under the same specificity, the sensitivity and accuracy of ICDC are higher than other diagnostic criteria in focal-type AIP. ICDC has better diagnostic performance compared with previously proposed diagnostic criteria in diffuse-type and focal-type AIP. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Screening criteria for increased susceptibility to heat stress during work or leisure in hot environments in healthy individuals aged 31-70 years.

PubMed

Flouris, Andreas D; McGinn, Ryan; Poirier, Martin P; Louie, Jeffrey C; Ioannou, Leonidas G; Tsoutsoubi, Lydia; Sigal, Ronald J; Boulay, Pierre; Hardcastle, Stephen G; Kenny, Glen P

2018-01-01

Population aging and global warming generate important public health risks, as older adults have increased susceptibility to heat stress (SHS). We defined and validated sex-specific screening criteria for SHS during work and leisure activities in hot environments in individuals aged 31-70 years using age, anthropometry, and cardiorespiratory fitness. A total of 123 males and 44 females [44 ± 14 years; 22.9 ± 7.4% body fat; 40.3 ± 8.6 peak oxygen uptake (mlO 2 /kg/min)] participated, separated into the Analysis (n = 111) and Validation (n = 56) groups. Within these groups, participants were categorized into YOUNG (19-30 years; n = 47) and OLDER (31-70 years; n = 120). All participants performed exercise in the heat inside a direct calorimeter. Screening criteria for OLDER participants were defined from the Analysis group and were cross-validated in the Validation group. Results showed that 30% of OLDER individuals in the Analysis group were screened as SHS positive. A total of 274 statistically valid (p < 0.05) criteria were identified suggesting that OLDER participants were at risk for SHS when demonstrating two or more of the following (males/females): age ≥ 53.0/55.8 years; body mass index ≥29.5/25.7 kg/m 2 ; body fat percentage ≥ 28.8/34.9; body surface area ≤2.0/1.7 m 2 ; peak oxygen uptake ≤48.3/41.4 mlO 2 /kg fat free mass/min. In the Validation group, McNemar χ 2 comparisons confirmed acceptable validity for the developed criteria. We conclude that the developed criteria can effectively screen individuals 31-70 years who are at risk for SHS during work and leisure activities in hot environments and can provide simple and effective means to mitigate the public health risks caused by heat exposure.

The reliability and validity of the Turkish version of fibromyalgia survey diagnostic criteria and symptom severity scale.

PubMed

Yanmaz, Muyesser Nergiz; Atar, Sevgi; Biçer, Mualla

2016-04-27

The fibromyalgia survey diagnostic criteria and severity scale (FSDC) is a self-reported version of 2010 preliminary diagnostic criteria for fibromyalgia syndrome (FMS). FSDC not only facilitates to diagnose FMS, it measures pain (the Widespread Pain Index (WPI)/FSDC Section 3), the Symptom Severity (SS)/FSDC Sections 1 and 2, and provides a score, polysymptomatic distress (PSD)/FSDC Total score in patients with FMS. The purpose of our study is to evaluate the reliability and validity of Turkish version of FSDC in Turkish patients with FMS. The Turkish version FSDC was obtained by two forward translations of the instrument into Turkish by two bilingual Turkish individuals, one of them was a physician. They were then back translated into English by two different bilingual individuals; another Turkish physician and a backtranslator whose mother tongue was English. The original version of FSDC, the two Turkish forward translations, and English back translations were then reviewed by the individuals involved in translations, and the last experimental Turkish version was created. This last version of Turkish FSDC studied on patients with newly diagnosed FMS by using American College of Rheumatology (ACR) 1990 classification criteria. Patients filled validated Turkish revised fibromyalgia impact questionnaire (rFIQ), our nonvalidated experimental Turkish FSDC; marked Visual Analog Scale (VAS) for pain and the disease severity. In 7 to 15 days, they have filled the nonvalidated Turkish FSDC for the second time. In 132 patients, by the test to retest reliability analysis of nonvalidated Turkish FSDC, for the 25 single items, correlation coefficients ranged 0.383 to 0.818 (all p< 0.01). There were significant correlations between nonvalidated Turkish FSDC assessment 1 and assessment 2 for Section 1+2 (SS) (r = 0.748), Section 3 (WPI) (r = 0.775), and the total scores (PSD) (r = 0.821) (all p< 0.01). Cronbach alpha was 0.766 for the nonvalidated Turkish FSDC assessment 1

DCD lung donation: donor criteria, procedural criteria, pulmonary graft function validation, and preservation.

PubMed

Erasmus, Michiel E; van Raemdonck, Dirk; Akhtar, Mohammed Zeeshan; Neyrinck, Arne; de Antonio, David Gomez; Varela, Andreas; Dark, John

2016-07-01

In an era where there is a shortage of lungs for transplantation is increased utilization of lungs from donation after circulatory death (DCD) donors. We review the reports of 11 controlled and 1 uncontrolled DCD programs focusing on donor criteria, procedural criteria, graft assessment, and preservation techniques including the use of ex vivo lung perfusion. We have formulated conclusions and recommendations for each of these areas, which were presented at the 6th International Conference on Organ Donation. A table of recommendations, the grade of recommendations, and references are provided. © 2015 Steunstichting ESOT.

Common Criteria related security design patterns--validation on the intelligent sensor example designed for mine environment.

PubMed

Bialas, Andrzej

2010-01-01

The paper discusses the security issues of intelligent sensors that are able to measure and process data and communicate with other information technology (IT) devices or systems. Such sensors are often used in high risk applications. To improve their robustness, the sensor systems should be developed in a restricted way to provide them with assurance. One of assurance creation methodologies is Common Criteria (ISO/IEC 15408), used for IT products and systems. The contribution of the paper is a Common Criteria compliant and pattern-based method for the intelligent sensors security development. The paper concisely presents this method and its evaluation for the sensor detecting methane in a mine, focusing on the security problem of the intelligent sensor definition and solution. The aim of the validation is to evaluate and improve the introduced method.

Exploring critical factors influencing physicians' acceptance of mobile electronic medical records based on the dual-factor model: a validation in Taiwan.

PubMed

Liu, Chung-Feng; Cheng, Tain-Junn

2015-02-07

With respect to information management, most of the previous studies on the acceptance of healthcare information technologies were analyzed from "positive" perspectives. However, such acceptance is always influenced by both positive and negative factors and it is necessary to validate both in order to get a complete understanding. This study aims to explore physicians' acceptance of mobile electronic medical records based on the dual-factor model, which is comprised of inhibitors and enablers, to explain an individual's technology usage. Following an earlier healthcare study in the USA, the researchers conducted a similar survey for an Eastern country (Taiwan) to validate whether perceived threat to professional autonomy acts as a critical inhibitor. In addition, perceived mobility, which is regarded as a critical feature of mobile services, was also evaluated as a common antecedent variable in the model. Physicians from three branch hospitals of a medical group were invited to participate and complete questionnaires. Partial least squares, a structural equation modeling technique, was used to evaluate the proposed model for explanatory power and hypotheses testing. 158 valid questionnaires were collected, yielding a response rate of 33.40%. As expected, the inhibitor of perceived threat has a significant impact on the physicians' perceptions of usefulness as well as their intention to use. The enablers of perceived ease of use and perceived usefulness were also significant. In addition, as expected, perceived mobility was confirmed to have a significant impact on perceived ease of use, perceived usefulness and perceived threat. It was confirmed that the dual-factor model is a comprehensive method for exploring the acceptance of healthcare information technologies, both in Western and Eastern countries. Furthermore, perceived mobility was proven to be an effective antecedent variable in the model. The researchers believe that the results of this study will

Instrument for assessing mobile technology acceptability in diabetes self-management: a validation and reliability study.

PubMed

Frandes, Mirela; Deiac, Anca V; Timar, Bogdan; Lungeanu, Diana

2017-01-01

Nowadays, mobile technologies are part of everyday life, but the lack of instruments to assess their acceptability for the management of chronic diseases makes their actual adoption for this purpose slow. The objective of this study was to develop a survey instrument for assessing patients' attitude toward and intention to use mobile technology for diabetes mellitus (DM) self-management, as well as to identify sociodemographic characteristics and quality of life factors that affect them. We first conducted the documentation and instrument design phases, which were subsequently followed by the pilot study and instrument validation. Afterward, the instrument was administered 103 patients (median age: 37 years; range: 18-65 years) diagnosed with type 1 or type 2 DM, who accepted to participate in the study. The reliability and construct validity were assessed by computing Cronbach's alpha and using factor analysis, respectively. The instrument included statements about the actual use of electronic devices for DM management, interaction between patient and physician, attitude toward using mobile technology, and quality of life evaluation. Cronbach's alpha was 0.9 for attitude toward using mobile technology and 0.97 for attitude toward using mobile device applications for DM self-management. Younger patients (Spearman's ρ =-0.429; P <0.001) with better glycemic control (Spearman's ρ =-0.322; P <0.001) and higher education level (Kendall's τ =0.51; P <0.001) had significantly more favorable attitude toward using mobile assistive applications for DM control. Moreover, patients with a higher quality of life presented a significantly more positive attitude toward using modern technology (Spearman's ρ =0.466; P <0.001). The instrument showed good reliability and internal consistency, making it suitable for measuring the acceptability of mobile technology for DM self-management. Additionally, we found that even if most of the patients showed positive attitude toward

Instrument for assessing mobile technology acceptability in diabetes self-management: a validation and reliability study

PubMed Central

Frandes, Mirela; Deiac, Anca V; Timar, Bogdan; Lungeanu, Diana

2017-01-01

Background Nowadays, mobile technologies are part of everyday life, but the lack of instruments to assess their acceptability for the management of chronic diseases makes their actual adoption for this purpose slow. Objective The objective of this study was to develop a survey instrument for assessing patients’ attitude toward and intention to use mobile technology for diabetes mellitus (DM) self-management, as well as to identify sociodemographic characteristics and quality of life factors that affect them. Methods We first conducted the documentation and instrument design phases, which were subsequently followed by the pilot study and instrument validation. Afterward, the instrument was administered 103 patients (median age: 37 years; range: 18–65 years) diagnosed with type 1 or type 2 DM, who accepted to participate in the study. The reliability and construct validity were assessed by computing Cronbach’s alpha and using factor analysis, respectively. Results The instrument included statements about the actual use of electronic devices for DM management, interaction between patient and physician, attitude toward using mobile technology, and quality of life evaluation. Cronbach’s alpha was 0.9 for attitude toward using mobile technology and 0.97 for attitude toward using mobile device applications for DM self-management. Younger patients (Spearman’s ρ=−0.429; P<0.001) with better glycemic control (Spearman’s ρ=−0.322; P<0.001) and higher education level (Kendall’s τ=0.51; P<0.001) had significantly more favorable attitude toward using mobile assistive applications for DM control. Moreover, patients with a higher quality of life presented a significantly more positive attitude toward using modern technology (Spearman’s ρ=0.466; P<0.001). Conclusion The instrument showed good reliability and internal consistency, making it suitable for measuring the acceptability of mobile technology for DM self-management. Additionally, we found that even

Construct and Predictive Validity of Social Acceptability: Scores From High School Teacher Ratings on the School Intervention Rating Form

ERIC Educational Resources Information Center

Harrison, Judith R.; State, Talida M.; Evans, Steven W.; Schamberg, Terah

2016-01-01

The purpose of this study was to evaluate the construct and predictive validity of scores on a measure of social acceptability of class-wide and individual student intervention, the School Intervention Rating Form (SIRF), with high school teachers. Utilizing scores from 158 teachers, exploratory factor analysis revealed a three-factor (i.e.,…

Validation of the Technology Acceptance Measure for Pre-Service Teachers (TAMPST) on a Malaysian Sample: A Cross-Cultural Study

ERIC Educational Resources Information Center

Teo, Timothy

2010-01-01

Purpose: The purpose of this paper is to assess the cross-cultural validity of the technology acceptance measure for pre-service teachers (TAMPST) on a Malaysian sample. Design/methodology/approach: A total of 193 pre-service teachers from a Malaysian university completed a survey questionnaire measuring their responses to five constructs in the…

Minimum training criteria for police traffic accident reconstruction.

DOT National Transportation Integrated Search

1987-03-01

This report summarizes the development of a set of minimum training criteria for police accident reconstructionists. Prior to this effort, no nationally accepted standards or criteria were recognized for evaluating the qualifications of police engage...

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

PubMed

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

[Validity, reliability, and acceptability of the brief version of the self-management knowledge, attitude, and behavior assessment scale for diabetes patients].

PubMed

Wu, Y Z; Wang, W J; Feng, N P; Chen, B; Li, G C; Liu, J W; Liu, H L; Yang, Y Y

2016-07-06

To evaluate the validity, reliability, and acceptability of the brief version of the self-management knowledge, attitude, and behavior (KAB) assessment scale for diabetes patients. Diabetes patients who were managed at the Xinkaipu Community Health Service Center of Tianxin in Changsha, Hunan Province were selected for survey by cluster sampling. A total of 350 diabetes patients were surveyed using the brief scale to collect data on knowledge, attitudes, and behaviors of self-management. Content validity was evaluated by Pearson correlation coefficient between the brief scale and subscales of knowledge, attitude, and behavior. Structure validity was evaluated by factor analysis, and discrimination validity was evaluated by an independent sample t-test between the high-score and low-score groups. Reliability was tested by internal consistency reliability and split-half reliability. The evaluation indexes of internal consistency reliability were Cronbach's α coefficients, θ coefficient, and Ω coefficient. Acceptability was evaluated by valid response rate and completion time of the brief scale. A total of 346(98.9%) valid questionnaires were returned, with average survey time of (11.43±3.4) minutes. Average score of the brief scale was 78.85 ± 11.22; scores of the knowledge, attitude, and behavior subscales were 16.45 ± 4.42, 21.33 ± 2.03, and 41.07 ± 8.34, respectively. Pearson correlation coefficients between the brief scale and the knowledge, attitude, and behavior subscales were 0.92, 0.42, and 0.60, respectively; P-values were all less than 0.01, indicating that the face validity and content validity of the brief scale were achieved to a good level. The common factor cumulative variance contribution rate of the brief scale and three subscales was from 53.66% to 61.75%, which achieved more than 50% of the approved standard. There were 11 common factors; 41 of the total 42 items had factor loadings above 0.40 in their relevant common factor, indicating

16 CFR 1616.4 - Sampling and acceptance procedures.

Code of Federal Regulations, 2011 CFR

2011-01-01

... specimen to one of the three samples. Test each set of three samples and accept or reject each seam design... all the test criteria of § 1616.3(b), accept the seam design. If one or more of the three additional.... Test the sets of three samples and accept or reject the type of trim and design on the same basis as...

16 CFR 1616.4 - Sampling and acceptance procedures.

Code of Federal Regulations, 2012 CFR

2012-01-01

... specimen to one of the three samples. Test each set of three samples and accept or reject each seam design... all the test criteria of § 1616.3(b), accept the seam design. If one or more of the three additional.... Test the sets of three samples and accept or reject the type of trim and design on the same basis as...

16 CFR 1616.4 - Sampling and acceptance procedures.

Code of Federal Regulations, 2010 CFR

2010-01-01

... specimen to one of the three samples. Test each set of three samples and accept or reject each seam design... all the test criteria of § 1616.3(b), accept the seam design. If one or more of the three additional.... Test the sets of three samples and accept or reject the type of trim and design on the same basis as...

Common Criteria Related Security Design Patterns—Validation on the Intelligent Sensor Example Designed for Mine Environment

PubMed Central

Bialas, Andrzej

2010-01-01

The paper discusses the security issues of intelligent sensors that are able to measure and process data and communicate with other information technology (IT) devices or systems. Such sensors are often used in high risk applications. To improve their robustness, the sensor systems should be developed in a restricted way to provide them with assurance. One of assurance creation methodologies is Common Criteria (ISO/IEC 15408), used for IT products and systems. The contribution of the paper is a Common Criteria compliant and pattern-based method for the intelligent sensors security development. The paper concisely presents this method and its evaluation for the sensor detecting methane in a mine, focusing on the security problem of the intelligent sensor definition and solution. The aim of the validation is to evaluate and improve the introduced method. PMID:22399888

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

NASA Technical Reports Server (NTRS)

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.

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

PubMed

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

EU landfill waste acceptance criteria and EU Hazardous Waste Directive compliance testing of incinerated sewage sludge ash.

PubMed

Donatello, S; Tyrer, M; Cheeseman, C R

2010-01-01

A hazardous waste assessment has been completed on ash samples obtained from seven sewage sludge incinerators operating in the UK, using the methods recommended in the EU Hazardous Waste Directive. Using these methods, the assumed speciation of zinc (Zn) ultimately determines if the samples are hazardous due to ecotoxicity hazard. Leaching test results showed that two of the seven sewage sludge ash samples would require disposal in a hazardous waste landfill because they exceed EU landfill waste acceptance criteria for stabilised non-reactive hazardous waste cells for soluble selenium (Se). Because Zn cannot be proven to exist predominantly as a phosphate or oxide in the ashes, it is recommended they be considered as non-hazardous waste. However leaching test results demonstrate that these ashes cannot be considered as inert waste, and this has significant implications for the management, disposal and re-use of sewage sludge ash.

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

PubMed

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.

Crew Transportation Technical Standards and Design Evaluation Criteria

NASA Technical Reports Server (NTRS)

Lueders, Kathryn L.; Thomas, Rayelle E. (Compiler)

2015-01-01

Crew Transportation Technical Standards and Design Evaluation Criteria contains descriptions of technical, safety, and crew health medical processes and specifications, and the criteria which will be used to evaluate the acceptability of the Commercial Providers' proposed processes and specifications.

[Chronic pain disorder with somatic and psychological factors (F45.41) : Validation criteria on operationalization of the ICD-10-GM diagnosis].

PubMed

Arnold, B; Lutz, J; Nilges, P; Pfingsten, M; Rief, Winfried; Böger, A; Brinkschmidt, T; Casser, H-R; Irnich, D; Kaiser, U; Klimczyk, K; Sabatowski, R; Schiltenwolf, M; Söllner, W

2017-12-01

In 2009 the diagnosis chronic pain disorder with somatic and psychological factors (F45.41) was integrated into the German version of the International Classification of Diseases, version 10 (ICD-10-GM). In 2010 Paul Nilges and Winfried Rief published operationalization criteria for this diagnosis. In the present publication the ad hoc commission on multimodal interdisciplinary pain therapy of the German Pain Society now presents a formula for a clear validation of these operationalization criteria of the ICD code F45.41.

Validation of the Fibromyalgia Survey Questionnaire within a Cross-Sectional Survey

PubMed Central

Häuser, Winfried; Jung, Eva; Erbslöh-Möller, Brigitte; Gesmann, Mechthild; Kühn-Becker, Hedi; Petermann, Franz; Langhorst, Jost; Weiss, Thomas; Winkelmann, Andreas; Wolfe, Frederick

2012-01-01

The Fibromyalgia Survey Questionnaire (FSQ) assesses the key symptoms of fibromyalgia syndrome. The FSQ can be administrated in survey research and settings where the use of interviews to evaluate the number of pain sites and extent of somatic symptom intensity and tender point examination would be difficult. We validated the FSQ in a cross-sectional survey with FMS patients. In a cross-sectional survey, participants with physician diagnosis of FMS were recruited by FMS-self help organisations and nine clinical institutions of different levels of care. Participants answered the FSQ (composed by the Widespread Pain Index [WPI] and the Somatic Severity Score [SSS]) assessing the Fibromyalgia Survey Diagnostic Criteria (FSDC) and the Patient Health Questionnaire PHQ 4. American College of Rheumatology 1990 classification criteria were assessed in a subgroup of participants. 1,651 persons diagnosed with FMS were included into analysis. The acceptance of the FSQ-items ranged between 78.9 to 98.1% completed items. The internal consistency of the items of the SSS ranged between 0.75–0.82. 85.5% of the study participants met the FSDC. The concordance rate of the FSDC and ACR 1990 criteria was 72.7% in a subsample of 128 patients. The Pearson correlation of the SSS with the PHQ 4 depression score was 0.52 (p<0.0001) and with the PHQ anxiety score was 0.51 (p<0.0001) (convergent validity). 64/202 (31.7%) of the participants not meeting the FSDC criteria and 152/1283 (11.8%) of the participants meeting the FSDC criteria reported an improvement (slightly too very much better) in their health status since FMS-diagnosis (Chi2 = 55, p<0.0001) (discriminant validity). The study demonstrated the feasibility of the FSQ in a cross-sectional survey with FMS-patients. The reliability, convergent and discriminant validity of the FSQ were good. Further validation studies of the FSQ in clinical and general population settings are necessary. PMID:22662163

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

PubMed

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 < 0.001) of the 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.

Evaluating the reliability, validity, acceptability, and practicality of SMS text messaging as a tool to collect research data: results from the Feeding Your Baby project.

PubMed

Whitford, Heather M; Donnan, Peter T; Symon, Andrew G; Kellett, Gillian; Monteith-Hodge, Ewa; Rauchhaus, Petra; Wyatt, Jeremy C

2012-01-01

To test the reliability, validity, acceptability, and practicality of short message service (SMS) messaging for collection of research data. The studies were carried out in a cohort of recently delivered women in Tayside, Scotland, UK, who were asked about their current infant feeding method and future feeding plans. Reliability was assessed by comparison of their responses to two SMS messages sent 1 day apart. Validity was assessed by comparison of their responses to text questions and the same question administered by phone 1 day later, by comparison with the same data collected from other sources, and by correlation with other related measures. Acceptability was evaluated using quantitative and qualitative questions, and practicality by analysis of a researcher log. Reliability of the factual SMS message gave perfect agreement. Reliabilities for the numerical question were reasonable, with κ between 0.76 (95% CI 0.56 to 0.96) and 0.80 (95% CI 0.59 to 1.00). Validity for data compared with that collected by phone within 24 h (κ =0.92 (95% CI 0.84 to 1.00)) and with health visitor data (κ =0.85 (95% CI 0.73 to 0.97)) was excellent. Correlation validity between the text responses and other related demographic and clinical measures was as expected. Participants found the method a convenient and acceptable way of providing data. For researchers, SMS text messaging provided an easy and functional method of gathering a large volume of data. In this sample and for these questions, SMS was a reliable and valid method for capturing research data.

Diagnostic Criteria for Cannabis Withdrawal Syndrome

PubMed Central

Gorelick, David A.; Levin, Kenneth H.; Copersino, Marc L.; Heishman, Stephen J.; Liu, Fang; Boggs, Douglas L.; Kelly, Deanna L.

2011-01-01

Objective Cannabis withdrawal occurs in frequent users who quit, but there are no accepted diagnostic criteria for a cannabis withdrawal syndrome (CWS). This study evaluated diagnostic criteria for CWS proposed in DSM-V and two earlier proposals. Method A convenience sample of 384 adult, non-treatment-seeking lifetime cannabis smokers provided retrospective self-report data on their “most difficult” quit attempt without formal treatment, which was used in this secondary analysis. Prevalence, time of onset, and peak intensity (5-point Likert scale) for 39 withdrawal symptoms (drawn from the literature) were assessed via computer-administered questionnaire. Subject groups were compared using chi-square or ANOVA. Symptom clustering was evaluated with principal components analysis. Results 40.9% of subjects met the DSM-V criterion of ≥ 3 symptoms from a list of 7. There were no associations with sex, race, or type of cannabis preparation used. There were significant positive associations between duration or frequency of cannabis use prior to the quit attempt and experiencing CWS. Subjects with CWS had a significantly shorter duration of abstinence. Alternative syndromal criteria (dropping physical symptoms from DSM-V list; requiring ≥ 2or ≥ 4 symptoms from a list of 11) yielded a similar prevalence of CWS and similar associations with prior cannabis use and relapse. The PCA yielded 12 factors, including some symptom clusters not included in DSM-V. Conclusions Findings support the concurrent and predictive validity of the proposed DSM-V CWS, but suggest that the list of withdrawal symptoms and number required for diagnosis warrant further evaluation. PMID:22153944

STOPP/START Medication Criteria Modified for US Nursing Home Setting

PubMed Central

Khodyakov, Dmitry; Ochoa, Aileen; Olivieri-Mui, Brianne L.; Bouwmeester, Carla; Zarowitz, Barbara J.; Patel, Meenakshi; Ching, Diana; Briesacher, Becky

2016-01-01

STRUCTURED ABSTRACT BACKGROUND/OBJECTIVES A barrier to assessing the quality of prescribing in nursing homes (NH) is the lack of explicit criteria for this setting. Our objective was to develop a set of prescribing indicators measurable with available data from electronic nursing home databases by adapting the European-based 2014 STOPP/START criteria of potentially inappropriate and underused medications for the US setting. DESIGN A two-stage expert panel process. In first stage, investigator team reviewed 114 criteria for compatibility and measurability. In second stage, we convened an online modified e-Delphi (OMD) panel to rate the validity of criteria and two webinars to identify criteria with highest relevance to US NHs. PARTICIPANTS Seventeen experts with recognized reputations in NH care participated in the e-Delphi panel and 12 in the webinar. MEASUREMENTS Compatibility and measurability were assessed by comparing criteria to US terminology/setting standards and data elements in NH databases. Validity was rated with a 9-point Likert-type scale (1=not valid at all, 9=highly valid). Mean, median, interpercentile ranges, and agreement were determined for each criterion score. Relevance was determined by ranking the mean panel ratings on criteria that reached agreement; half of the criteria with the highest mean values were reviewed and approved by the webinar participants. RESULTS Fifty-three STOPP/START criteria were deemed as compatible with US setting and measurable using data from electronic NH databases. E-Delphi panelists rated 48 criteria as valid for US NHs. Twenty-four criteria were deemed as most relevant, consisting of 22 measures of potentially inappropriate medications and 2 measures of underused medications. CONCLUSION This study created the first explicit criteria for assessing the quality of prescribing in US NHs. PMID:28008599

16 CFR § 1616.4 - Sampling and acceptance procedures.

Code of Federal Regulations, 2013 CFR

2013-01-01

... specimen to one of the three samples. Test each set of three samples and accept or reject each seam design... all the test criteria of § 1616.3(b), accept the seam design. If one or more of the three additional.... Test the sets of three samples and accept or reject the type of trim and design on the same basis as...

Transfer of training for aerospace operations: How to measure, validate, and improve it

NASA Technical Reports Server (NTRS)

Cohen, Malcolm M.

1993-01-01

It has been a commonly accepted practice to train pilots and astronauts in expensive, extremely sophisticated, high fidelity simulators, with as much of the real-world feel and response as possible. High fidelity and high validity have often been assumed to be inextricably interwoven, although this assumption may not be warranted. The Project Mercury rate-damping task on the Naval Air Warfare Center's Human Centrifuge Dynamic Flight Simulator, the shuttle landing task on the NASA-ARC Vertical Motion Simulator, and the almost complete acceptance by the airline industry of full-up Boeing 767 flight simulators, are just a few examples of this approach. For obvious reasons, the classical models of transfer of training have never been adequately evaluated in aerospace operations, and there have been few, if any, scientifically valid replacements for the classical models. This paper reviews some of the earlier work involving transfer of training in aerospace operations, and discusses some of the methods by which appropriate criteria for assessing the validity of training may be established.

Validation Test Report For The CRWMS Analysis and Logistics Visually Interactive Model Calvin Version 3.0, 10074-Vtr-3.0-00

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

S. Gillespie

2000-07-27

This report describes the tests performed to validate the CRWMS ''Analysis and Logistics Visually Interactive'' Model (CALVIN) Version 3.0 (V3.0) computer code (STN: 10074-3.0-00). To validate the code, a series of test cases was developed in the CALVIN V3.0 Validation Test Plan (CRWMS M&O 1999a) that exercises the principal calculation models and options of CALVIN V3.0. Twenty-five test cases were developed: 18 logistics test cases and 7 cost test cases. These cases test the features of CALVIN in a sequential manner, so that the validation of each test case is used to demonstrate the accuracy of the input to subsequentmore » calculations. Where necessary, the test cases utilize reduced-size data tables to make the hand calculations used to verify the results more tractable, while still adequately testing the code's capabilities. Acceptance criteria, were established for the logistics and cost test cases in the Validation Test Plan (CRWMS M&O 1999a). The Logistics test cases were developed to test the following CALVIN calculation models: Spent nuclear fuel (SNF) and reactivity calculations; Options for altering reactor life; Adjustment of commercial SNF (CSNF) acceptance rates for fiscal year calculations and mid-year acceptance start; Fuel selection, transportation cask loading, and shipping to the Monitored Geologic Repository (MGR); Transportation cask shipping to and storage at an Interim Storage Facility (ISF); Reactor pool allocation options; and Disposal options at the MGR. Two types of cost test cases were developed: cases to validate the detailed transportation costs, and cases to validate the costs associated with the Civilian Radioactive Waste Management System (CRWMS) Management and Operating Contractor (M&O) and Regional Servicing Contractors (RSCs). For each test case, values calculated using Microsoft Excel 97 worksheets were compared to CALVIN V3.0 scenarios with the same input data and assumptions. All of the test case results compare with the

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

PubMed

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.

Working towards accreditation by the International Standards Organization 15189 Standard: how to validate an in-house developed method an example of lead determination in whole blood by electrothermal atomic absorption spectrometry.

PubMed

Garcia Hejl, Carine; Ramirez, Jose Manuel; Vest, Philippe; Chianea, Denis; Renard, Christophe

2014-09-01

Laboratories working towards accreditation by the International Standards Organization (ISO) 15189 standard are required to demonstrate the validity of their analytical methods. The different guidelines set by various accreditation organizations make it difficult to provide objective evidence that an in-house method is fit for the intended purpose. Besides, the required performance characteristics tests and acceptance criteria are not always detailed. The laboratory must choose the most suitable validation protocol and set the acceptance criteria. Therefore, we propose a validation protocol to evaluate the performance of an in-house method. As an example, we validated the process for the detection and quantification of lead in whole blood by electrothermal absorption spectrometry. The fundamental parameters tested were, selectivity, calibration model, precision, accuracy (and uncertainty of measurement), contamination, stability of the sample, reference interval, and analytical interference. We have developed a protocol that has been applied successfully to quantify lead in whole blood by electrothermal atomic absorption spectrometry (ETAAS). In particular, our method is selective, linear, accurate, and precise, making it suitable for use in routine diagnostics.

Validation of Automated Scores of TOEFL iBT® Tasks against Nontest Indicators of Writing Ability. TOEFL iBT® Research Report. TOEFL iBT-15. ETS Research Report RR-11-24

ERIC Educational Resources Information Center

Weigle, Sara Cushing

2011-01-01

Automated scoring has the potential to dramatically reduce the time and costs associated with the assessment of complex skills such as writing, but its use must be validated against a variety of criteria for it to be accepted by test users and stakeholders. This study addresses two validity-related issues regarding the use of e-rater® with the…

Development and implementation of centralized simulation training: evaluation of feasibility, acceptability and construct validity.

PubMed

Shamim Khan, Mohammad; Ahmed, Kamran; Gavazzi, Andrea; Gohil, Rishma; Thomas, Libby; Poulsen, Johan; Ahmed, Munir; Jaye, Peter; Dasgupta, Prokar

2013-03-01

WHAT'S KNOWN ON THE SUBJECT? AND WHAT DOES THE STUDY ADD?: A competent urologist should not only have effective technical skills, but also other attributes that would make him/her a complete surgeon. These include team-working, communication and decision-making skills. Although evidence for effectiveness of simulation exists for individual simulators, there is a paucity of evidence for utility and effectiveness of these simulators in training programmes that aims to combine technical and non-technical skills training. This article explains the process of development and validation of a centrally coordinated simulation program (Participants - South-East Region Specialist Registrars) under the umbrella of the British Association for Urological Surgeons (BAUS) and the London Deanery. This program incorporated training of both technical (synthetic, animal and virtual reality models) and non-technical skills (simulated operating theatres). To establish the feasibility and acceptability of a centralized, simulation-based training-programme. Simulation is increasingly establishing its role in urological training, with two areas that are relevant to urologists: (i) technical skills and (ii) non-technical skills. For this London Deanery supported pilot Simulation and Technology enhanced Learning Initiative (STeLI) project, we developed a structured multimodal simulation training programme. The programme incorporated: (i) technical skills training using virtual-reality simulators (Uro-mentor and Perc-mentor [Symbionix, Cleveland, OH, USA], Procedicus MIST-Nephrectomy [Mentice, Gothenburg, Sweden] and SEP Robotic simulator [Sim Surgery, Oslo, Norway]); bench-top models (synthetic models for cystocopy, transurethral resection of the prostate, transurethral resection of bladder tumour, ureteroscopy); and a European (Aalborg, Denmark) wet-lab training facility; as well as (ii) non-technical skills/crisis resource management (CRM), using SimMan (Laerdal Medical Ltd, Orpington, UK

Comparison of consumer perception and acceptability for steaks cooked to different endpoints: validation of photographic approach.

PubMed

Chan, Sheung-Hang; Moss, Bruce W; Farmer, Linda J; Gordon, Alan; Cuskelly, Geraldine J

2013-02-15

Photographs have been used to enhance consumer reporting of preference of meat doneness, however, the use of photographs has not been validated for this purpose. This study used standard cooking methods to produce steaks of five different degrees of doneness (rare medium, medium well, well done and very well done) to study the consumer's perception of doneness, from both the external and internal surface of the cooked steak and also from corresponding photographs of each sample. Consumers evaluated each surface of the cooked steaks in relation to doneness for acceptability, 'just about right' and perception of doneness. Data were analysed using a split plot ANOVA and least significant test. Perception scores (for both external and internal surfaces) between different presentation methods (steak samples and corresponding photos), were not significantly different (p>0.05). The result indicates that photographs can be used as a valid approach for assessing preference for meat doneness. Copyright © 2012 Elsevier Ltd. All rights reserved.

PDB_REDO: constructive validation, more than just looking for errors.

PubMed

Joosten, Robbie P; Joosten, Krista; Murshudov, Garib N; Perrakis, Anastassis

2012-04-01

Developments of the PDB_REDO procedure that combine re-refinement and rebuilding within a unique decision-making framework to improve structures in the PDB are presented. PDB_REDO uses a variety of existing and custom-built software modules to choose an optimal refinement protocol (e.g. anisotropic, isotropic or overall B-factor refinement, TLS model) and to optimize the geometry versus data-refinement weights. Next, it proceeds to rebuild side chains and peptide planes before a final optimization round. PDB_REDO works fully automatically without the need for intervention by a crystallographic expert. The pipeline was tested on 12 000 PDB entries and the great majority of the test cases improved both in terms of crystallographic criteria such as R(free) and in terms of widely accepted geometric validation criteria. It is concluded that PDB_REDO is useful to update the otherwise `static' structures in the PDB to modern crystallographic standards. The publically available PDB_REDO database provides better model statistics and contributes to better refinement and validation targets.

PDB_REDO: constructive validation, more than just looking for errors

PubMed Central

Joosten, Robbie P.; Joosten, Krista; Murshudov, Garib N.; Perrakis, Anastassis

2012-01-01

Developments of the PDB_REDO procedure that combine re-refinement and rebuilding within a unique decision-making framework to improve structures in the PDB are presented. PDB_REDO uses a variety of existing and custom-built software modules to choose an optimal refinement protocol (e.g. anisotropic, isotropic or overall B-factor refinement, TLS model) and to optimize the geometry versus data-refinement weights. Next, it proceeds to rebuild side chains and peptide planes before a final optimization round. PDB_REDO works fully automatically without the need for intervention by a crystallographic expert. The pipeline was tested on 12 000 PDB entries and the great majority of the test cases improved both in terms of crystallographic criteria such as R free and in terms of widely accepted geometric validation criteria. It is concluded that PDB_REDO is useful to update the otherwise ‘static’ structures in the PDB to modern crystallographic standards. The publically available PDB_REDO database provides better model statistics and contributes to better refinement and validation targets. PMID:22505269

The PEDro scale had acceptably high convergent validity, construct validity, and interrater reliability in evaluating methodological quality of pharmaceutical trials.

PubMed

Yamato, Tie Parma; Maher, Chris; Koes, Bart; Moseley, Anne

2017-06-01

The Physiotherapy Evidence Database (PEDro) scale has been widely used to investigate methodological quality in physiotherapy randomized controlled trials; however, its validity has not been tested for pharmaceutical trials. The aim of this study was to investigate the validity and interrater reliability of the PEDro scale for pharmaceutical trials. The reliability was also examined for the Cochrane Back and Neck (CBN) Group risk of bias tool. This is a secondary analysis of data from a previous study. We considered randomized placebo controlled trials evaluating any pain medication for chronic spinal pain or osteoarthritis. Convergent validity was evaluated by correlating the PEDro score with the summary score of the CBN risk of bias tool. The construct validity was tested using a linear regression analysis to determine the degree to which the total PEDro score is associated with treatment effect sizes, journal impact factor, and the summary score for the CBN risk of bias tool. The interrater reliability was estimated using the Prevalence and Bias Adjusted Kappa coefficient and 95% confidence interval (CI) for the PEDro scale and CBN risk of bias tool. Fifty-three trials were included, with 91 treatment effect sizes included in the analyses. The correlation between PEDro scale and CBN risk of bias tool was 0.83 (95% CI 0.76-0.88) after adjusting for reliability, indicating strong convergence. The PEDro score was inversely associated with effect sizes, significantly associated with the summary score for the CBN risk of bias tool, and not associated with the journal impact factor. The interrater reliability for each item of the PEDro scale and CBN risk of bias tool was at least substantial for most items (>0.60). The intraclass correlation coefficient for the PEDro score was 0.80 (95% CI 0.68-0.88), and for the CBN, risk of bias tool was 0.81 (95% CI 0.69-0.88). There was evidence for the convergent and construct validity for the PEDro scale when used to evaluate

Evaluating the reliability, validity, acceptability, and practicality of SMS text messaging as a tool to collect research data: results from the Feeding Your Baby project

PubMed Central

Donnan, Peter T; Symon, Andrew G; Kellett, Gillian; Monteith-Hodge, Ewa; Rauchhaus, Petra; Wyatt, Jeremy C

2012-01-01

Objective To test the reliability, validity, acceptability, and practicality of short message service (SMS) messaging for collection of research data. Materials and methods The studies were carried out in a cohort of recently delivered women in Tayside, Scotland, UK, who were asked about their current infant feeding method and future feeding plans. Reliability was assessed by comparison of their responses to two SMS messages sent 1 day apart. Validity was assessed by comparison of their responses to text questions and the same question administered by phone 1 day later, by comparison with the same data collected from other sources, and by correlation with other related measures. Acceptability was evaluated using quantitative and qualitative questions, and practicality by analysis of a researcher log. Results Reliability of the factual SMS message gave perfect agreement. Reliabilities for the numerical question were reasonable, with κ between 0.76 (95% CI 0.56 to 0.96) and 0.80 (95% CI 0.59 to 1.00). Validity for data compared with that collected by phone within 24 h (κ =0.92 (95% CI 0.84 to 1.00)) and with health visitor data (κ =0.85 (95% CI 0.73 to 0.97)) was excellent. Correlation validity between the text responses and other related demographic and clinical measures was as expected. Participants found the method a convenient and acceptable way of providing data. For researchers, SMS text messaging provided an easy and functional method of gathering a large volume of data. Conclusion In this sample and for these questions, SMS was a reliable and valid method for capturing research data. PMID:22539081

2017 Draft Aquatic Life Criteria for Aluminum in Freshwater

EPA Pesticide Factsheets

EPA has released draft updated aluminum aquatic life ambient water quality criteria for freshwater under Section 304(a)(1) of the Clean Water Act. EPA will accept public comments on the draft criteria for 60 days upon publication in the Federal Register.

Guillain-Barré syndrome in Bangladesh: validation of Brighton criteria.

PubMed

Islam, Mohammad B; Islam, Zhahirul; Farzana, Kaniz S; Sarker, Sumit K; Endtz, Hubert P; Mohammad, Quazi D; Jacobs, Bart C

2016-12-01

Guillain-Barré syndrome has a diverse clinical phenotype related to geographical origin. To date, the majority of large-scale studies on Guillain-Barré syndrome (GBS) have been conducted in developed countries. We aimed to evaluate the key diagnostic features and assess the suitability of the Brighton criteria in 344 adult GBS patients from Bangladesh. All patients fulfilled the National Institute of Neurological Diseases and Stroke (NINDS) diagnostic criteria. Standardized data on demographic characteristics and clinical features, cerebrospinal fluid (CSF) analysis, and nerve conduction study (NCS) results were elaborated to measure the sensitivity of Brighton criteria. Most patients (88%) were admitted to hospital after the nadir weakness. Symmetrical weakness and reduced reflexes were found in 98% of patients. CSF albuminocytologic dissociation was detected in 238/269 (89%) cases and abnormal nerve physiology in 258/259 (>99%) cases. Only 27 (8%) patients received either intravenous immunoglobulin (IVIg) or plasmapheresis. In total, 200 (58%) patients met level 1 of the Brighton criteria; 97 (28%) patients met level 2; 42 (12%) patients met level 3; and 5 (2%) patients met level 4. This analysis showed that despite the heterogeneity of GBS in Bangladesh, the Brighton criteria showed a high sensitivity in the diagnosis of GBS. © 2016 Peripheral Nerve Society.

21 CFR 820.80 - Receiving, in-process, and finished device acceptance.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Receiving, in-process, and finished device acceptance. 820.80 Section 820.80 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria...

21 CFR 820.80 - Receiving, in-process, and finished device acceptance.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Receiving, in-process, and finished device acceptance. 820.80 Section 820.80 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria...

Explicit criteria for prioritization of cataract surgery

PubMed Central

Ma Quintana, José; Escobar, Antonio; Bilbao, Amaia

2006-01-01

Background Consensus techniques have been used previously to create explicit criteria to prioritize cataract extraction; however, the appropriateness of the intervention was not included explicitly in previous studies. We developed a prioritization tool for cataract extraction according to the RAND method. Methods Criteria were developed using a modified Delphi panel judgment process. A panel of 11 ophthalmologists was assembled. Ratings were analyzed regarding the level of agreement among panelists. We studied the effect of all variables on the final panel score using general linear and logistic regression models. Priority scoring systems were developed by means of optimal scaling and general linear models. The explicit criteria developed were summarized by means of regression tree analysis. Results Eight variables were considered to create the indications. Of the 310 indications that the panel evaluated, 22.6% were considered high priority, 52.3% intermediate priority, and 25.2% low priority. Agreement was reached for 31.9% of the indications and disagreement for 0.3%. Logistic regression and general linear models showed that the preoperative visual acuity of the cataractous eye, visual function, and anticipated visual acuity postoperatively were the most influential variables. Alternative and simple scoring systems were obtained by optimal scaling and general linear models where the previous variables were also the most important. The decision tree also shows the importance of the previous variables and the appropriateness of the intervention. Conclusion Our results showed acceptable validity as an evaluation and management tool for prioritizing cataract extraction. It also provides easy algorithms for use in clinical practice. PMID:16512893

On Validity Theory and Test Validation

ERIC Educational Resources Information Center

Sireci, Stephen G.

2007-01-01

Lissitz and Samuelsen (2007) propose a new framework for conceptualizing test validity that separates analysis of test properties from analysis of the construct measured. In response, the author of this article reviews fundamental characteristics of test validity, drawing largely from seminal writings as well as from the accepted standards. He…

Self-Reported Acceptance of Social Anxiety Symptoms: Development and Validation of the Social Anxiety-Acceptance and Action Questionnaire

ERIC Educational Resources Information Center

MacKenzie, Meagan B.; Kocovski, Nancy L.

2010-01-01

Mindfulness and acceptance-based interventions have been used in social anxiety treatments with initial success. Further research requires the psychometrically sound measurement of mechanisms of change associated with these treatments. This research was conducted to develop and evaluate such a measure, the Social Anxiety-Acceptance and Action…

A systematic review of patient acceptance of consumer health information technology.

PubMed

Or, Calvin K L; Karsh, Ben-Tzion

2009-01-01

A systematic literature review was performed to identify variables promoting consumer health information technology (CHIT) acceptance among patients. The electronic bibliographic databases Web of Science, Business Source Elite, CINAHL, Communication and Mass Media Complete, MEDLINE, PsycArticles, and PsycInfo were searched. A cited reference search of articles meeting the inclusion criteria was also conducted to reduce misses. Fifty-two articles met the selection criteria. Among them, 94 different variables were tested for associations with acceptance. Most of those tested (71%) were patient factors, including sociodemographic characteristics, health- and treatment-related variables, and prior experience or exposure to computer/health technology. Only ten variables were related to human-technology interaction; 16 were organizational factors; and one was related to the environment. In total, 62 (66%) were found to predict acceptance in at least one study. Existing literature focused largely on patient-related factors. No studies examined the impact of social and task factors on acceptance, and few tested the effects of organizational or environmental factors on acceptance. Future research guided by technology acceptance theories should fill those gaps to improve our understanding of patient CHIT acceptance, which in turn could lead to better CHIT design and implementation.

Evaluation Criteria for the Educational Web-Information System

ERIC Educational Resources Information Center

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…

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

PubMed Central

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

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

PubMed

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

Service User- and Carer-Reported Measures of Involvement in Mental Health Care Planning: Methodological Quality and Acceptability to Users

PubMed Central

Gibbons, Chris J.; Bee, Penny E.; Walker, Lauren; Price, Owen; Lovell, Karina

2014-01-01

Background: Increasing service user and carer involvement in mental health care planning is a key healthcare priority but one that is difficult to achieve in practice. To better understand and measure user and carer involvement, it is crucial to have measurement questionnaires that are both psychometrically robust and acceptable to the end user. Methods: We conducted a systematic review using the terms “care plan$,” “mental health,” “user perspective$,” and “user participation” and their linguistic variants as search terms. Databases were searched from inception to November 2012, with an update search at the end of September 2014. We included any articles that described the development, validation or use of a user and/or carer-reported outcome measures of involvement in mental health care planning. We assessed the psychometric quality of each instrument using the “Evaluating the Measurement of Patient-Reported Outcomes” (EMPRO) criteria. Acceptability of each instrument was assessed using novel criteria developed in consultation with a mental health service user and carer consultation group. Results: We identified eleven papers describing the use, development, and/or validation of nine user/carer-reported outcome measures. Psychometric properties were sparsely reported and the questionnaires met few service user/carer-nominated attributes for acceptability. Where reported, basic psychometric statistics were of good quality, indicating that some measures may perform well if subjected to more rigorous psychometric tests. The majority were deemed to be too long for use in practice. Discussion: Multiple instruments are available to measure user/carer involvement in mental health care planning but are either of poor quality or poorly described. Existing measures cannot be considered psychometrically robust by modern standards, and cannot currently be recommended for use. Our review has identified an important knowledge gap, and an urgent need to

Validation of a Spanish version of the psychological inflexibility in pain scale (PIPS) and an evaluation of its relation with acceptance of pain and mindfulness in sample of persons with fibromyalgia

PubMed Central

2013-01-01

Background Psychological flexibility has been suggested as a fundamental process in health. The Psychological Inflexibility in Pain Scale (PIPS) is one of the scales employed for assessing psychological inflexibility in pain patients. The aim of this study was to validate the Spanish version of the PIPS and secondly, to compare it to two other psychological constructs, the acceptance of pain and mindfulness scales. Methods The PIPS was translated into Spanish by two bilingual linguistic experts, and then, back-translated into English to assess for equivalence. The final Spanish version was administered along with the Pain Visual Analogue Scale, Fibromyalgia Impact Questionnaire, Hospital Anxiety Depression Scale, Pain Catastrophizing Scale, Chronic Pain Acceptance Questionnaire and the Mindful Attention Awareness Scale, to 250 Spanish patients with fibromyalgia. Face validity, construct validity, reliability (internal consistency and test-retest) and convergent validity were tested. Also a multiple regression analysis was carried out.The usual guidelines have been followed for cross-cultural adaptations. Results Data were very similar to the ones obtained in the original PIPS version. The construct validity confirmed the original two-components solution which explained 61.6% of the variance. The Spanish PIPS had good test-retest reliability (intraclass correlation coefficient 0.97) and internal consistency reliability (Cronbach’s alpha: 0.90). The Spanish PIPS’ score correlated significantly with worse global functioning (r = 0.55), anxiety (r = 0.54), depression (r = 0.66), pain catastrophizing (r = 0.62), pain acceptance (r = −0.72) and mindfulness (r = −0.47), as well as correlating modestly with pain intensity (r = 0.12). The multiple regression analyses showed that psychological inflexibility, acceptance and mindfulness are not overlapped. Conclusions The Spanish PIPS scale appears to be a valid and reliable instrument for the evaluation of

The Youth Diversity Acceptance Scale: Development and Validity

ERIC Educational Resources Information Center

Beck, Kara L.; Acevedo-Polakovich, Ignacio D.; Lyons, Eileen; Estevez, Jessica; Sevecke, Jessica R.; Rossman, Danielle L.; Barnett, Miya L.; Fisher, Heidi R.

2018-01-01

To facilitate rigorous research on community programs to promote positive intergroup relations among youth, 2 studies were conducted to establish the psychometric properties of the Youth Diversity Acceptance Scale (YoDA). In Study 1, a unifactorial structure was identified for the YoDA using data provided by 126 high school youth involved in a…

Factors Affecting Acceptance & Use of ReWIND: Validating the Extended Unified Theory of Acceptance and Use of Technology

ERIC Educational Resources Information Center

Nair, Pradeep Kumar; Ali, Faizan; Leong, Lim Chee

2015-01-01

Purpose: This study aims to explain the factors affecting students' acceptance and usage of a lecture capture system (LCS)--ReWIND--in a Malaysian university based on the extended unified theory of acceptance and use of technology (UTAUT2) model. Technological advances have become an important feature of universities' plans to improve the…

Validity of the ATP III diagnostic criteria for the metabolic syndrome in an elderly Italian Caucasian population: the Italian Longitudinal Study on Aging.

PubMed

Maggi, Stefania; Noale, Marianna; Zambon, Alberto; Limongi, Federica; Romanato, Giovanna; Crepaldi, Gaetano

2008-04-01

The metabolic syndrome (MetS) is represented by the co-occurrence of multiple metabolic and physiologic risk factors for both type 2 diabetes mellitus and atherosclerotic cardiovascular diseases. In spite of its high frequency and association with morbidity and mortality in the adult population, very little is known about its magnitude in the elderly and about the validity of the diagnostic criteria commonly used. The objective of this paper is to assess the prevalence rate of MetS and the validity of the Adult Treatment Panel III (ATP III) diagnostic criteria in an elderly Caucasian cohort, considering data from the Italian Longitudinal Study on Aging (ILSA), a population-based study with a sample of 5632 individuals aged 65-84 years at baseline (1992). Logistic regression models and ROC curve were used to test the validity of the cut off levels proposed. The prevalence of MetS was 31.5% in men, and 59.8% in women. The cut off levels suggested for both men and women by the ATP III panel indicated a significant association with the MetS for all components. Actually, the ROC analysis would suggest lower levels for glycaemia (106 mg/dl) in men, and higher levels for blood pressure in both men and women (145/95 and 135/90, respectively). Concluding, MetS is very common in the aged Caucasians and the diagnostic criteria proposed by the ATP III panel seem to be appropriate in older individuals. Small adjustments in the cut off levels could be suggested for glycaemia (men) and in blood pressure (men and women).

Negotiable Acceptability: Reflections on the Interactions between Language Professionals in Europe and NNS Scientists Wishing to Publish in English

ERIC Educational Resources Information Center

Burrough-Boenisch, Joy

2006-01-01

Prior to submitting a paper to a science journal, many European scientists employ language professionals to check that the English is acceptable. What influences these language professionals' criteria of acceptability? How do they interact with the authors for whom they work? And how do journals' criteria of acceptability affect their work? In…

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

PubMed

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 (p<0.0001). Statistically signi cant differences in the number of TP (p<0.03), FIQ (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.

PubMed

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.

Independent Verification and Validation (IV and V) Criteria

NASA Technical Reports Server (NTRS)

McGill, Kenneth

2000-01-01

The purpose of this appendix is to establish quantifiable criteria for determining whether IV&V should be applied to a given software development. Since IV&V should begin in the Formulation Subprocess of a project, the process here described is based on metrics which are available before project approval.

The HealthNuts population-based study of paediatric food allergy: validity, safety and acceptability.

PubMed

Osborne, N J; Koplin, J J; Martin, P E; Gurrin, L C; Thiele, L; Tang, M L; Ponsonby, A-L; Dharmage, S C; Allen, K J

2010-10-01

The incidence of hospital admissions for food allergy-related anaphylaxis in Australia has increased, in line with world-wide trends. However, a valid measure of food allergy prevalence and risk factor data from a population-based study is still lacking. To describe the study design and methods used to recruit infants from a population for skin prick testing and oral food challenges, and the use of preliminary data to investigate the extent to which the study sample is representative of the target population. The study sampling frame design comprises 12-month-old infants presenting for routine scheduled vaccination at immunization clinics in Melbourne, Australia. We compared demographic features of participating families to population summary statistics from the Victorian Perinatal census database, and administered a survey to those non-responders who chose not to participate in the study. Study design proved acceptable to the community with good uptake (response rate 73.4%), with 2171 participants recruited. Demographic information on the study population mirrored the Victorian population with most the population parameters measured falling within our confidence intervals (CI). Use of a non-responder questionnaire revealed that a higher proportion of infants who declined to participate (non-responders) were already eating and tolerating peanuts, than those agreeing to participate (54.4%; 95% CI 50.8, 58.0 vs. 27.4%; 95% CI 25.5, 29.3 among participants). A high proportion of individuals approached in a community setting participated in a food allergy study. The study population differed from the eligible sample in relation to family history of allergy and prior consumption and peanut tolerance, providing some insights into the internal validity of the sample. The study exhibited external validity on general demographics to all births in Victoria. © 2010 Blackwell Publishing Ltd.

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

PubMed

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.

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

PubMed

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.

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

PubMed

Riewe, E; Neubauer, E; Pfeifer, A C; Schiltenwolf, M

2016-01-01

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.

A research for Class II defect Bored Pile’s Accept Criteria: A case of Penang Second Marine bridge

NASA Astrophysics Data System (ADS)

Huang, Kang

2018-03-01

The aim of this preliminary research is to study the accept criteria of class II bored pile with subtle defect. According to a detailed comparison of the existed different standards, Chinese ones are more applicable especially for the large diameter bored piles. Through the concrete coring at pile No P25-03 of this case and the comparison to the actual calculation, the Class II pile’s defects were very minor. Comparison was also made for the effects on pile structural capacities before and after repair of the defects. the feasible repair proposal may bring forward to more defects to the piles. The Class II piles don’t need any further repairation when piles have typical of similar character and sonic logging test result with P25-03‘s one. For other Class II piles with some differences in characters, verification is needed through further concrete coring on the pile. The recommendation of this research could be adopted for the similar huge marine structures which installed large diameter bored piles.

Design criteria for maglev structures

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

Sandberg, H.R.; Williams, J.R.

1997-05-01

Maglev systems represent an entirely new concept in transportation. They will not operate on nor share the right-of-way with any other system. It is important, therefore, that the guideways be designed and constructed so as to be economical, constructable, durable, adaptable, reliable, and readily maintained. Comparisons should be made with the current transportation systems, especially highways and railroads. Since most of the guideway will be elevated, the comparison should be with the bridges. The object of the comparisons should be to avoid the shortcomings of the other systems while building on their strengths. This paper develops in some detail designmore » and construction criteria that will ensure a good, long-lived performance of the maglev guideway. The importance of beauty should have a low priority in comparison to the other design criteria. Clean, simple details meeting other criteria will ensure an acceptable appearance. These criteria were used in evaluating the four maglev concepts developed for the National Maglev Initiative.« less

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

PubMed

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.

Genres Across Cultures: Types of Acceptability Variation

ERIC Educational Resources Information Center

Shaw, Philip; Gillaerts, Paul; Jacobs, Everett; Palermo, Ofelia; Shinohara, Midori; Verckens, J. Piet

2004-01-01

One can ask four questions about genre validity across cultures. Does a certain form or configuration occur in the culture in question? Is it acceptable? If acceptable, is it in practice preferred? Is it recommended by prescriptive authorities? This paper reports the results of an attempt to answer these questions empirically by testing the…

Validity Evidence in Scale Development: The Application of Cross Validation and Classification-Sequencing Validation

ERIC Educational Resources Information Center

Acar, Tu¨lin

2014-01-01

In literature, it has been observed that many enhanced criteria are limited by factor analysis techniques. Besides examinations of statistical structure and/or psychological structure, such validity studies as cross validation and classification-sequencing studies should be performed frequently. The purpose of this study is to examine cross…

Development and validation of a measure of health literacy in the UK: the newest vital sign

PubMed Central

2013-01-01

Background Health literacy (HL) is an important public health issue. Current measures have drawbacks in length and/or acceptability. The US-developed Newest Vital Sign (NVS) health literacy instrument measures both reading comprehension and numeracy skills using a nutrition label, takes 3 minutes to administer, and has proven to be acceptable to research subjects. This study aimed to amend and validate it for the UK population. Methods We used a three-stage process; (1) a Delphi study with academic and clinical experts to amend the NVS label to reflect UK nutrition labeling (2) community-based cognitive testing to assess and improve ease of understanding and acceptability of the test (3) validation of the NVS-UK against an accepted standard test of health literacy, the Test of Functional Health Literacy in Adults (TOFHLA) (Pearson’s r and the area under the Receiver Operating Characteristic (ROC) curve) and participant educational level. A sample size calculation indicated that 250 participants would be required. Inclusion criteria were age 18–75 years and ability to converse in English. We excluded people working in the health field and those with impaired vision or inability to undertake the interview due to cognitive impairment or inability to converse in English. Results In the Delphi study, 28 experts reached consensus (3 cycles). Cognitive testing (80 participants) yielded an instrument that needed no further refinement. Validation testing (337 participants) showed high internal consistency (Cronbach’s Alpha = 0.74). Validation against the TOFHLA demonstrated a Pearson’s r of 0.49 and an area under the ROC curve of 0.81. Conclusions The NVS-UK is a valid measure of HL. Its acceptability and ease of application makes it an ideal tool for use in the UK. It has potential uses in public health research including epidemiological surveys and randomized controlled trials, and in enabling practitioners to tailor care to patient need. PMID:23391329

Development of flaw acceptance criteria for aging management of spent nuclear fuel multiple-purpose canisters

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

Lam, P.; Sindelar, R.

2015-03-09

A typical multipurpose canister (MPC) is made of austenitic stainless steel and is loaded with spent nuclear fuel assemblies. The canister may be subject to service-induced degradation when it is exposed to aggressive atmospheric environments during a possibly long-term storage period if the permanent repository is yet to be identified and readied. Because heat treatment for stress relief is not required for the construction of an MPC, stress corrosion cracking may be initiated on the canister surface in the welds or in the heat affected zone. An acceptance criteria methodology is being developed for flaw disposition should the crack-like defectsmore » be detected by periodic In-service Inspection. The first-order instability flaw sizes has been determined with bounding flaw configurations, that is, through-wall axial or circumferential cracks, and part-through-wall long axial flaw or 360° circumferential crack. The procedure recommended by the American Petroleum Institute (API) 579 Fitness-for-Service code (Second Edition) is used to estimate the instability crack length or depth by implementing the failure assessment diagram (FAD) methodology. The welding residual stresses are mostly unknown and are therefore estimated with the API 579 procedure. It is demonstrated in this paper that the residual stress has significant impact on the instability length or depth of the crack. The findings will limit the applicability of the flaw tolerance obtained from limit load approach where residual stress is ignored and only ligament yielding is considered.« less

Development of flaw acceptance criteria for aging management of spent nuclear fuel multi-purpose canisters

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

Lam, Poh -Sang; Sindelar, Robert L.

2015-03-09

A typical multipurpose canister (MPC) is made of austenitic stainless steel and is loaded with spent nuclear fuel assemblies. The canister may be subject to service-induced degradation when it is exposed to aggressive atmospheric environments during a possibly long-term storage period if the permanent repository is yet to be identified and readied. Because heat treatment for stress relief is not required for the construction of an MPC, stress corrosion cracking may be initiated on the canister surface in the welds or in the heat affected zone. An acceptance criteria methodology is being developed for flaw disposition should the crack-like defectsmore » be detected by periodic in-service Inspection. The first-order instability flaw sizes has been determined with bounding flaw configurations, that is, through-wall axial or circumferential cracks, and part-through-wall long axial flaw or 360° circumferential crack. The procedure recommended by the American Petroleum Institute (API) 579 Fitness-for-Service code (Second Edition) is used to estimate the instability crack length or depth by implementing the failure assessment diagram (FAD) methodology. The welding residual stresses are mostly unknown and are therefore estimated with the API 579 procedure. It is demonstrated in this paper that the residual stress has significant impact on the instability length or depth of the crack. The findings will limit the applicability of the flaw tolerance obtained from limit load approach where residual stress is ignored and only ligament yielding is considered.« less

76 FR 82201 - General Site Suitability Criteria for Nuclear Power Stations

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-30

..., and 52 [NRC-2011-0297] General Site Suitability Criteria for Nuclear Power Stations AGENCY: Nuclear... Suitability Criteria for Nuclear Power Stations.'' This guide describes a method that the NRC staff considers acceptable to implement the site suitability requirements for nuclear power stations. DATES: Submit comments...

Validation of "laboratory-supported" criteria for functional (psychogenic) tremor.

PubMed

Schwingenschuh, Petra; Saifee, Tabish A; Katschnig-Winter, Petra; Macerollo, Antonella; Koegl-Wallner, Mariella; Culea, Valeriu; Ghadery, Christine; Hofer, Edith; Pendl, Tamara; Seiler, Stephan; Werner, Ulrike; Franthal, Sebastian; Maurits, Natasha M; Tijssen, Marina A; Schmidt, Reinhold; Rothwell, John C; Bhatia, Kailash P; Edwards, Mark J

2016-04-01

In a small group of patients, we have previously shown that a combination of electrophysiological tests was able to distinguish functional (psychogenic) tremor and organic tremor with excellent sensitivity and specificity. This study aims to validate an electrophysiological test battery as a tool to diagnose patients with functional tremor with a "laboratory-supported" level of certainty. For this prospective data collection study, we recruited 38 new patients with functional tremor (mean age 37.9 ± 24.5 years; mean disease duration 5.9 ± 9.0 years) and 73 new patients with organic tremor (mean age 55.4 ± 25.4 years; mean disease duration 15.8 ± 17.7 years). Tremor was recorded at rest, posture (with and without loading), action, while performing tapping tasks (1, 3, and 5 Hz), and while performing ballistic movements with the less-affected hand. Electrophysiological tests were performed by raters blinded to the clinical diagnosis. We calculated a sum score for all performed tests (maximum of 10 points) and used a previously suggested cut-off score of 3 points for a diagnosis of laboratory-supported functional tremor. We demonstrated good interrater reliability and test-retest reliability. Patients with functional tremor had a higher average score on the test battery when compared with patients with organic tremor (3.6 ± 1.4 points vs 1.0 ± 0.8 points; P < .001), and the predefined cut-off score for laboratory-supported functional tremor yielded a test sensitivity of 89.5% and a specificity of 95.9%. We now propose this test battery as the basis of laboratory-supported criteria for the diagnosis of functional tremor, and we encourage its use in clinical and research practice. © 2016 International Parkinson and Movement Disorder Society.

Comprehensive Evaluation Criteria for English Learning Websites Using Expert Validity Surveys

ERIC Educational Resources Information Center

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…

Validation of accuracy and community acceptance of the BIRTHweigh III scale for categorizing newborn weight in rural India.

PubMed

Darmstadt, G L; Kumar, V; Shearer, J C; Misra, R; Mohanty, S; Baqui, A H; Coffey, P S; Awasthi, S; Singh, J V; Santosham, M

2007-10-01

To determine the accuracy and acceptability of a handheld scale prototype designed for nonliterate users to classify newborns into three weight categories (>or=2,500 g; 2,000 to 2,499 g; and <2,000 g). Weights of 1,100 newborns in Uttar Pradesh, India, were measured on the test scale and validated against a gold standard. Mothers, family members and community health stakeholders were interviewed to assess the acceptability of the test scale. The test scale was highly sensitive and specific at classifying newborn weight (normal weight: 95.3 and 96.3%, respectively; low birth weight: 90.4 and 99.2%, respectively; very low birth weight: 91.7 and 98.4%, respectively). It was the overall agreement of the community that the test scale was more practical and easier to interpret than the gold standard. The BIRTHweigh III scale accurately identifies low birth weight and very low birth weight newborns to target weight-specific interventions. The scale is extremely practical and useful for resource-poor settings, especially those with low levels of literacy.

Analyses related to the development of DSM-5 criteria for substance use related disorders: 3. An assessment of Pathological Gambling criteria.

PubMed

Denis, Cécile; Fatséas, Mélina; Auriacombe, Marc

2012-04-01

The DSM-5 Substance-Related Disorders Work Group proposed to include Pathological Gambling within the current Substance-Related Disorders section. The objective of the current report was to assess four possible sets of diagnostic criteria for Pathological Gambling. Gamblers (N=161) were defined as either Pathological or Non-Pathological according to four classification methods. (a) Option 1: the current DSM-IV criteria for Pathological Gambling; (b) Option 2: dropping the "Illegal Acts" criterion, while keeping the threshold at 5 required criteria endorsed; (c) Option 3: the proposed DSM-5 approach, i.e., deleting "Illegal Acts" and lowering the threshold of required criteria from 5 to 4; (d) Option 4: to use a set of Pathological Gambling criteria modeled on the DSM-IV Substance Dependence criteria. Cronbach's alpha and eigenvalues were calculated for reliability, Phi, discriminant function analyses, correlations and multivariate regression models were performed for validity and kappa coefficients were calculated for diagnostic consistency of each option. All criteria sets were reliable and valid. Some criteria had higher discriminant properties than others. The proposed DSM-5 criteria in Options 2 and 3 performed well and did not appear to alter the meanings of the diagnoses of Pathological Gambling from DSM-IV. Future work should further explore if Pathological Gambling might be assessed using the same criteria as those used for Substance Use Disorders. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Remarks on the Acceptance of Proofs: The Case of Some Recently Tackled Major Theorems.

ERIC Educational Resources Information Center

Neubrand, Michael

1989-01-01

Lists five criteria in the acceptance of mathematical theorems, such as understanding, significance, compatibility, reputation, and convincing argument. Concludes that social and language factors are involved in the process of the acceptance. (YP)

Validity of portfolio assessment: which qualities determine ratings?

PubMed

Driessen, Erik W; Overeem, Karlijn; van Tartwijk, Jan; van der Vleuten, Cees P M; Muijtjens, Arno M M

2006-09-01

The portfolio is becoming increasingly accepted as a valuable tool for learning and assessment. The validity of portfolio assessment, however, may suffer from bias due to irrelevant qualities, such as lay-out and writing style. We examined the possible effects of such qualities in a portfolio programme aimed at stimulating Year 1 medical students to reflect on their professional and personal development. In later curricular years, this portfolio is also used to judge clinical competence. We developed an instrument, the Portfolio Analysis Scoring Inventory, to examine the impact of form and content aspects on portfolio assessment. The Inventory consists of 15 items derived from interviews with experienced mentors, the literature, and the criteria for reflective competence used in the regular portfolio assessment procedure. Forty portfolios, selected from 231 portfolios for which ratings from the regular assessment procedure were available, were rated by 2 researchers, independently, using the Inventory. Regression analysis was used to estimate the correlation between the ratings from the regular assessment and those resulting from the Inventory items. Inter-rater agreement ranged from 0.46 to 0.87. The strongest predictor of the variance in the regular ratings was 'quality of reflection' (R 0.80; R2 66%). No further items accounted for a significant proportion of variance. Irrelevant items, such as writing style and lay-out, had negligible effects. The absence of an impact of irrelevant criteria appears to support the validity of the portfolio assessment procedure. Further studies should examine the portfolio's validity for the assessment of clinical competence.

A prospective study to validate various clinical criteria used in classification of leprosy: a study from a tertiary care center in India.

PubMed

Thapa, Manisha; Sendhil Kumaran, Muthu; Narang, Tarun; Saikia, Uma N; Sawatkar, Gitesh U; Dogra, Sunil

2018-05-29

Various clinical criteria are used to categorize leprosy patients into paucibacillary (PB) and multibacillary (MB), thus aiding in appropriate treatment. However, comprehensive studies validating these criteria are minimal. To assess sensitivity and specificity of different clinical criteria individually and in combination for classifying leprosy into PB/MB spectrum. A prospective study was conducted wherein 50 newly diagnosed, untreated leprosy cases were recruited and classified into PB and MB using the following clinical criteria: number of skin lesions (NSL), number of body areas affected (NBAA), and size of largest skin lesion (SLSL). Patients with pure neuritic leprosy, diffuse macular type of lepromatous leprosy, and with reactions were excluded. Sensitivity and specificity of these clinical criteria in classification was calculated taking histopathological findings as gold standard. Among 50 patients, 37 were males and 13 were females with a mean age of 32.08 ± 16.55 years. The sensitivity and specificity of NSL, NBAA, and SLSL was 94.74 and 87.1%, 94.74 and 61.29%, and 73.68 and 16.13%, respectively. Combining all three criteria, the sensitivity increased to 100%, but specificity decreased drastically to 12.9%. The ROC curve for NSL, NBAA, and SLSL showed a cutoff of ≥6 skin lesions, ≥3 body areas affected, and ≤2 cm lesion to classify as MB. The current WHO system of leprosy classification based on NSL seems to be best among available clinical criteria. Uniform and sensible application of this criteria itself assures appropriate categorizing and leprosy treatment with reasonable sensitivity and specificity. © 2018 The International Society of Dermatology.

Rational selection of training and test sets for the development of validated QSAR models

NASA Astrophysics Data System (ADS)

Golbraikh, Alexander; Shen, Min; Xiao, Zhiyan; Xiao, Yun-De; Lee, Kuo-Hsiung; Tropsha, Alexander

2003-02-01

Quantitative Structure-Activity Relationship (QSAR) models are used increasingly to screen chemical databases and/or virtual chemical libraries for potentially bioactive molecules. These developments emphasize the importance of rigorous model validation to ensure that the models have acceptable predictive power. Using k nearest neighbors ( kNN) variable selection QSAR method for the analysis of several datasets, we have demonstrated recently that the widely accepted leave-one-out (LOO) cross-validated R2 (q2) is an inadequate characteristic to assess the predictive ability of the models [Golbraikh, A., Tropsha, A. Beware of q2! J. Mol. Graphics Mod. 20, 269-276, (2002)]. Herein, we provide additional evidence that there exists no correlation between the values of q 2 for the training set and accuracy of prediction ( R 2) for the test set and argue that this observation is a general property of any QSAR model developed with LOO cross-validation. We suggest that external validation using rationally selected training and test sets provides a means to establish a reliable QSAR model. We propose several approaches to the division of experimental datasets into training and test sets and apply them in QSAR studies of 48 functionalized amino acid anticonvulsants and a series of 157 epipodophyllotoxin derivatives with antitumor activity. We formulate a set of general criteria for the evaluation of predictive power of QSAR models.

Selection criteria of residents for residency programs in Kuwait

PubMed Central

2013-01-01

Background In Kuwait, 21 residency training programs were offered in the year 2011; however, no data is available regarding the criteria of selecting residents for these programs. This study aims to provide information about the importance of these criteria. Methods A self-administered questionnaire was used to collect data from members (e.g. chairmen, directors, assistants …etc.) of residency programs in Kuwait. A total of 108 members were invited to participate. They were asked to rate the importance level (scale from 1 to 5) of criteria that may affect the acceptance of an applicant to their residency programs. Average scores were calculated for each criterion. Results Of the 108 members invited to participate, only 12 (11.1%) declined to participate. Interview performance was ranked as the most important criteria for selecting residents (average score: 4.63/5.00), followed by grade point average (average score: 3.78/5.00) and honors during medical school (average score: 3.67/5.00). On the other hand, receiving disciplinary action during medical school and failure in a required clerkship were considered as the most concerning among other criteria used to reject applicants (average scores: 3.83/5.00 and 3.54/5.00 respectively). Minor differences regarding the importance level of each criterion were noted across different programs. Conclusions This study provided general information about the criteria that are used to accept/reject applicants to residency programs in Kuwait. Future studies should be conducted to investigate each criterion individually, and to assess if these criteria are related to residents' success during their training. PMID:23331670

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

PubMed Central

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

[Validation and verfication of microbiology methods].

PubMed

Camaró-Sala, María Luisa; Martínez-García, Rosana; Olmos-Martínez, Piedad; Catalá-Cuenca, Vicente; Ocete-Mochón, María Dolores; Gimeno-Cardona, Concepción

2015-01-01

Clinical microbiologists should ensure, to the maximum level allowed by the scientific and technical development, the reliability of the results. This implies that, in addition to meeting the technical criteria to ensure their validity, they must be performed with a number of conditions that allows comparable results to be obtained, regardless of the laboratory that performs the test. In this sense, the use of recognized and accepted reference methodsis the most effective tool for these guarantees. The activities related to verification and validation of analytical methods has become very important, as there is continuous development, as well as updating techniques and increasingly complex analytical equipment, and an interest of professionals to ensure quality processes and results. The definitions of validation and verification are described, along with the different types of validation/verification, and the types of methods, and the level of validation necessary depending on the degree of standardization. The situations in which validation/verification is mandatory and/or recommended is discussed, including those particularly related to validation in Microbiology. It stresses the importance of promoting the use of reference strains as controls in Microbiology and the use of standard controls, as well as the importance of participation in External Quality Assessment programs to demonstrate technical competence. The emphasis is on how to calculate some of the parameters required for validation/verification, such as the accuracy and precision. The development of these concepts can be found in the microbiological process SEIMC number 48: «Validation and verification of microbiological methods» www.seimc.org/protocols/microbiology. Copyright © 2013 Elsevier España, S.L.U. y Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.

78 FR 64030 - Monitoring Criteria and Methods To Calculate Occupational Radiation Doses

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-25

... NUCLEAR REGULATORY COMMISSION [NRC-2013-0234] Monitoring Criteria and Methods To Calculate... regulatory guide (DG), DG-8031, ``Monitoring Criteria and Methods to Calculate Occupational Radiation Doses.'' This guide describes methods that the NRC staff considers acceptable for licensees to use to determine...

Psychological Flexibility of Nurses in a Cancer Hospital: Preliminary Validation of a Chinese Version of the Work-related Acceptance and Action Questionnaire.

PubMed

Xu, Xianghua; Liu, Xiangyu; Ou, Meijun; Xie, Chanjuan; Chen, Yongyi

2018-01-01

To translate the English work-related acceptance and action questionnaire (WAAQ), make cross-cultural adaptations, and examine its psychometric properties when used by Chinese oncology nurses. After translation, the psychometric properties of the Chinese WAAQ were analyzed among 417 nurses, and content validity was determined by six experts. Item-level content validity index (CVI) values were between 0.83 and 1.00; scale-level CVI/universal agreement (S-CVI/UA) and S-CVI/average were 0.86 and 0.98, respectively, which implicated a good content validity. The correlation of the Chinese WAAQ with AAQ-II ( r s = -0.247, P < 0.001) suggested criterion validity, and those with General Health Questionnaire-12 (-0.250, <0.001) and general self-efficacy scale (0.491, <0.001) and Utrecht work engagement scale (UWES) (0.439, <0.001) suggested convergent validity. Exploratory factor analysis identified a seven-item, one-factor structure of WAAQ. The Chinese version of WAAQ had high internal consistency (Cronbach's α = 0.920), with an item-total correlation coefficient of 0.702-0.828 ( P < 0.05), split-half reliability of 0.933, and test-retest reliability of 0.772. The Chinese WAAQ is a reliable and valid tool for assessing psychological flexibility in Chinese oncology nurses.

Assessment of Clinical Criteria for Sepsis

PubMed Central

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

The International Criteria for Behçet's Disease (ICBD): a collaborative study of 27 countries on the sensitivity and specificity of the new criteria.

PubMed

2014-03-01

Behçet's disease (BD) is a chronic, relapsing, inflammatory vascular disease with no pathognomonic test. Low sensitivity of the currently applied International Study Group (ISG) clinical diagnostic criteria led to their reassessment. An International Team for the Revision of the International Criteria for BD (from 27 countries) submitted data from 2556 clinically diagnosed BD patients and 1163 controls with BD-mimicking diseases or presenting at least one major BD sign. These were randomly divided into training and validation sets. Logistic regression, 'leave-one-country-out' cross-validation and clinical judgement were employed to develop new International Criteria for BD (ICBD) with the training data. Existing and new criteria were tested for their performance in the validation set. For the ICBD, ocular lesions, oral aphthosis and genital aphthosis are each assigned 2 points, while skin lesions, central nervous system involvement and vascular manifestations 1 point each. The pathergy test, when used, was assigned 1 point. A patient scoring ≥4 points is classified as having BD. In the training set, 93.9% sensitivity and 92.1% specificity were assessed compared with 81.2% sensitivity and 95.9% specificity for the ISG criteria. In the validation set, ICBD demonstrated an unbiased estimate of sensitivity of 94.8% (95% CI: 93.4-95.9%), considerably higher than that of the ISG criteria (85.0%). Specificity (90.5%, 95% CI: 87.9-92.8%) was lower than that of the ISG-criteria (96.0%), yet still reasonably high. For countries with at least 90%-of-cases and controls having a pathergy test, adding 1 point for pathergy test increased the estimate of sensitivity from 95.5% to 98.5%, while barely reducing specificity from 92.1% to 91.6%. The new proposed criteria derived from multinational data exhibits much improved sensitivity over the ISG criteria while maintaining reasonable specificity. It is proposed that the ICBD criteria to be adopted both as a guide for diagnosis

USGS to accept private funds

NASA Astrophysics Data System (ADS)

The U.S. Geological Survey (USGS), the federal government's largest earth science research agency, is now authorized to accept contributions from private sources and to collaborate with such sources in projects that support the agency's scientific research and its development of technology and data systems.Before the USGS can accept outside contributions, however, the proposed project must be deemed to be in the public interest and must be deemed compatible with the basic USGS mission. Among the responsibilities of the USGS, are assessing the nation's land, water, energy, and mineral resources and developing methods to define and mitigate hazards associated with earthquakes, volcanic eruptions, and landslides. Details on criteria and procedures for making contributions and entering into collaborative projects are outlined in the June 2 Federal Register.

Predicting the Operational Acceptability of Route Advisories

NASA Technical Reports Server (NTRS)

Evans, Antony; Lee, Paul

2017-01-01

NASA envisions a future Air Traffic Management system that allows safe, efficient growth in global operations, enabled by increasing levels of automation and autonomy. In a safety-critical system, the introduction of increasing automation and autonomy has to be done in stages, making human-system integrated concepts critical in the foreseeable future. One example where this is relevant is for tools that generate more efficient flight routings or reroute advisories. If these routes are not operationally acceptable, they will be rejected by human operators, and the associated benefits will not be realized. Operational acceptance is therefore required to enable the increased efficiency and reduced workload benefits associated with these tools. In this paper, the authors develop a predictor of operational acceptability for reroute advisories. Such a capability has applications in tools that identify more efficient routings around weather and congestion and that better meet airline preferences. The capability is based on applying data mining techniques to flight plan amendment data reported by the Federal Aviation Administration and data on requested reroutes collected from a field trial of the NASA developed Dynamic Weather Routes tool, which advised efficient route changes to American Airlines dispatchers in 2014. 10-Fold cross validation was used for feature, model and parameter selection, while nested cross validation was used to validate the model. The model performed well in predicting controller acceptance or rejection of a route change as indicated by chosen performance metrics. Features identified as relevant to controller acceptance included the historical usage of the advised route, the location of the maneuver start point relative to the boundaries of the airspace sector containing the maneuver start (the maneuver start sector), the reroute deviation from the original flight plan, and the demand level in the maneuver start sector. A random forest with forty

Validity, Responsibility, and Aporia

ERIC Educational Resources Information Center

Koro-Ljungberg, Mirka

2010-01-01

In this article, the author problematizes external, objectified, oversimplified, and mechanical approaches to validity in qualitative research, which endorse simplistic and reductionist views of knowledge and data. Instead of promoting one generalizable definition or operational criteria for validity, the author's "deconstructive validity work"…

Validation of Self-Image of Aging Scale for Chinese elders.

PubMed

Bai, Xue; Chan, K S; Chow, Nelson

2012-01-01

Researchers are increasingly interested in the "image of aging" concept. Models on the image of aging abound, but few have rigorously tested measures that are culturally sensitive and domain-specific. This study first translates Levy et al.'s (2004) Image of Aging Scale into the Chinese language and revises it into the Chinese Version of the Self-Image of Aging Scale (SIAS-C). Based on the results of a survey of 445 elderly people in Wuhan-China, it then reports the factorial structure of SIAS-C and some of its psychometric properties. Confirmatory factor analysis (CFA) supports a conceptually meaningful five-factor model, as suggested in an exploratory factor analysis (EFA). The 14-item SIAS-C vindicates an acceptable level of internal consistency and test-retest reliability. Its criteria-referenced validity is demonstrated by its correlation with several criteria in expected directions. In conclusion, the SIAS-C is a psychometrically sound instrument which is recommended for use among Chinese older people.

Developing an acceptability assessment of preventive dental treatments.

PubMed

Hyde, Susan; Gansky, Stuart A; Gonzalez-Vargas, Maria J; Husting, Sheila R; Cheng, Nancy F; Millstein, Susan G; Adams, Sally H

2009-01-01

Early childhood caries (ECC) is very prevalent among young Hispanic children. ECC is amenable to a variety of preventive procedures, yet many Hispanic families underutilize dental services. Acceptability research may assist in health care planning and resource allocation by identifying patient preferences among efficacious treatments with the goal of improving their utilization. The purposes of this study were (a) to develop a culturally competent acceptability assessment instrument, directed toward the caregivers of young Hispanic children, for five preventive dental treatments for ECC and (b) to test the instrument's reliability and validity. An instrument of five standard treatments known to prevent ECC was developed, translated, reviewed by focus groups, and pilot tested, then tested for reliability The instrument included illustrated cards, brief video clips, and samples of the treatments and was culturally appropriate for low-income Hispanic caregivers. In addition to determining the acceptability of the five treatments individually, the treatments were also presented as paired comparisons. Focus groups and debriefing interviews following the pilot tests established that the instrument has good face validity. The illustrated cards, product samples, and video demonstrations of the five treatments resulted in an instrument possessing good content validity. The instrument has good to excellent test-retest reliability, with identical time 1-time 2 responses for each of the five treatments 92 percent of the time (range 87 to 97 percent), and the same treatment of the paired comparisons preferred 75 percent of the time (range 61 to 90 percent). The acceptability instrument described is reliable and valid and may be useful in program planning efforts to identify and increase the utilization of preferred ECC preventive treatments for target populations.

Preliminary evaluation of an analog procedure to assess acceptability of intimate partner violence against women: the Partner Violence Acceptability Movie Task

PubMed Central

Gracia, Enrique; Rodriguez, Christina M.; Lila, Marisol

2015-01-01

Acceptability of partner violence against women is a risk factor linked to its perpetration, and to public, professionals’ and victims’ responses to this behavior. Research on the acceptability of violence in intimate partner relationships is, however, limited by reliance solely on self-reports that often provide distorted or socially desirable accounts that may misrepresent respondents’ attitudes. This study presents data on the development and initial validation of a new analog task assessing respondents’ acceptability of physical violence toward women in intimate relationships: the Partner Violence Acceptability Movie Task (PVAM). This new analog task is intended to provide a more implicit measure of the acceptability of partner violence against women. For this analog task, clips were extracted from commercially available films (90-s segments) portraying partner violence. Two independent samples were used to develop and evaluate the PVAM: a sample of 245 undergraduate students and a sample of 94 male intimate partner violence offenders. This new analog task demonstrated acceptable internal consistency. Results also indicated adequate construct validity. Both perpetrators and undergraduates scoring high in the PVAM also scored higher in self-reported justifications of partner abuse. Perpetrators of partner violence scored significantly higher in acceptability of partner violence than the undergraduate sample (both male and female students), and male students scored higher than females. These preliminary results suggest that the PVAM may be a promising tool to assess the acceptability of violence in intimate partner relationships, highlighting the need to consider alternatives to self-report to evaluate potential beliefs about partner violence. PMID:26528220

Micro-CT imaging: Developing criteria for examining fetal skeletons in regulatory developmental toxicology studies - A workshop report.

PubMed

Solomon, Howard M; Makris, Susan L; Alsaid, Hasan; Bermudez, Oscar; Beyer, Bruce K; Chen, Antong; Chen, Connie L; Chen, Zhou; Chmielewski, Gary; DeLise, Anthony M; de Schaepdrijver, Luc; Dogdas, Belma; French, Julian; Harrouk, Wafa; Helfgott, Jonathan; Henkelman, R Mark; Hesterman, Jacob; Hew, Kok-Wah; Hoberman, Alan; Lo, Cecilia W; McDougal, Andrew; Minck, Daniel R; Scott, Lelia; Stewart, Jane; Sutherland, Vicki; Tatiparthi, Arun K; Winkelmann, Christopher T; Wise, L David; Wood, Sandra L; Ying, Xiaoyou

2016-06-01

During the past two decades the use and refinements of imaging modalities have markedly increased making it possible to image embryos and fetuses used in pivotal nonclinical studies submitted to regulatory agencies. Implementing these technologies into the Good Laboratory Practice environment requires rigorous testing, validation, and documentation to ensure the reproducibility of data. A workshop on current practices and regulatory requirements was held with the goal of defining minimal criteria for the proper implementation of these technologies and subsequent submission to regulatory agencies. Micro-computed tomography (micro-CT) is especially well suited for high-throughput evaluations, and is gaining popularity to evaluate fetal skeletons to assess the potential developmental toxicity of test agents. This workshop was convened to help scientists in the developmental toxicology field understand and apply micro-CT technology to nonclinical toxicology studies and facilitate the regulatory acceptance of imaging data. Presentations and workshop discussions covered: (1) principles of micro-CT fetal imaging; (2) concordance of findings with conventional skeletal evaluations; and (3) regulatory requirements for validating the system. Establishing these requirements for micro-CT examination can provide a path forward for laboratories considering implementing this technology and provide regulatory agencies with a basis to consider the acceptability of data generated via this technology. Published by Elsevier Inc.

[Revision of McDonald's new diagnostic criteria for multiple sclerosis].

PubMed

Wiendl, H; Kieseier, B C; Gold, R; Hohlfeld, R; Bendszus, M; Hartung, H-P

2006-10-01

In 2001, an international panel suggested new diagnostic criteria for multiple sclerosis (MS). These criteria integrate clinical, imaging (MRI), and paraclinical results in order to facilitate diagnosis. Since then, these so-called McDonald criteria have been broadly accepted and widely propagated. In the meantime a number of publications have dealt with the sensitivity and specificity for MS diagnosis and with implementing these new criteria in clinical practice. Based on these empirical values and newer data on MS, an international expert group recently proposed a revision of the criteria. Substantial changes affect (1) MRI criteria for the dissemination of lesions over time, (2) the role of spinal cord lesions in the MRI and (3) diagnosis of primary progressive MS. In this article we present recent experiences with the McDonald and revised criteria.

Multi-criteria development and incorporation into decision tools for health technology adoption.

PubMed

Poulin, Paule; Austen, Lea; Scott, Catherine M; Waddell, Cameron D; Dixon, Elijah; Poulin, Michelle; Lafrenière, René

2013-01-01

When introducing new health technologies, decision makers must integrate research evidence with local operational management information to guide decisions about whether and under what conditions the technology will be used. Multi-criteria decision analysis can support the adoption or prioritization of health interventions by using criteria to explicitly articulate the health organization's needs, limitations, and values in addition to evaluating evidence for safety and effectiveness. This paper seeks to describe the development of a framework to create agreed-upon criteria and decision tools to enhance a pre-existing local health technology assessment (HTA) decision support program. The authors compiled a list of published criteria from the literature, consulted with experts to refine the criteria list, and used a modified Delphi process with a group of key stakeholders to review, modify, and validate each criterion. In a workshop setting, the criteria were used to create decision tools. A set of user-validated criteria for new health technology evaluation and adoption was developed and integrated into the local HTA decision support program. Technology evaluation and decision guideline tools were created using these criteria to ensure that the decision process is systematic, consistent, and transparent. This framework can be used by others to develop decision-making criteria and tools to enhance similar technology adoption programs. The development of clear, user-validated criteria for evaluating new technologies adds a critical element to improve decision-making on technology adoption, and the decision tools ensure consistency, transparency, and real-world relevance.

Introducing the fit-criteria assessment plot - A visualisation tool to assist class enumeration in group-based trajectory modelling.

PubMed

Klijn, Sven L; Weijenberg, Matty P; Lemmens, Paul; van den Brandt, Piet A; Lima Passos, Valéria

2017-10-01

Background and objective Group-based trajectory modelling is a model-based clustering technique applied for the identification of latent patterns of temporal changes. Despite its manifold applications in clinical and health sciences, potential problems of the model selection procedure are often overlooked. The choice of the number of latent trajectories (class-enumeration), for instance, is to a large degree based on statistical criteria that are not fail-safe. Moreover, the process as a whole is not transparent. To facilitate class enumeration, we introduce a graphical summary display of several fit and model adequacy criteria, the fit-criteria assessment plot. Methods An R-code that accepts universal data input is presented. The programme condenses relevant group-based trajectory modelling output information of model fit indices in automated graphical displays. Examples based on real and simulated data are provided to illustrate, assess and validate fit-criteria assessment plot's utility. Results Fit-criteria assessment plot provides an overview of fit criteria on a single page, placing users in an informed position to make a decision. Fit-criteria assessment plot does not automatically select the most appropriate model but eases the model assessment procedure. Conclusions Fit-criteria assessment plot is an exploratory, visualisation tool that can be employed to assist decisions in the initial and decisive phase of group-based trajectory modelling analysis. Considering group-based trajectory modelling's widespread resonance in medical and epidemiological sciences, a more comprehensive, easily interpretable and transparent display of the iterative process of class enumeration may foster group-based trajectory modelling's adequate use.

Initial interlaboratory validation of an analytical method for the determination of lead in canned tuna to be used for monitoring and regulatory purposes.

PubMed

Santiago, E C; Bello, F B B

2003-06-01

The Association of Official Analytical Chemists (AOAC) Standard Method 972.23 (dry ashing and flame atomic absorption spectrophotometry (FAAS)), applied to the analysis of lead in tuna, was validated in three selected local laboratories to determine the acceptability of the method to both the Codex Alimentarius Commission (Codex) and the European Union (EU) Commission for monitoring lead in canned tuna. Initial validation showed that the standard AOAC method as performed in the three participating laboratories cannot satisfy the Codex/EU proposed criteria for the method detection limit for monitoring lead in fish at the present regulation level of 0.5 mg x kg(-1). Modification of the standard method by chelation/concentration of the digest solution before FAAS analysis showed that the modified method has the potential to meet Codex/EU criteria on sensitivity, accuracy and precision at the specified regulation level.

The importance of having a flexible scope ISO 15189 accreditation and quality specifications based on biological variation--the case of validation of the biochemistry analyzer Dimension Vista.

PubMed

Fernandez-Calle, Pilar; Pelaz, Sandra; Oliver, Paloma; Alcaide, Maria Jose; Gomez-Rioja, Ruben; Buno, Antonio; Iturzaeta, Jose Manuel

2013-01-01

Technological innovation requires the laboratories to ensure that modifications or incorporations of new techniques do not alter the quality of their results. In an ISO 15189 accredited laboratory, flexible scope accreditation facilitates the inclusion of these changes prior to accreditation body evaluation. A strategy to perform the validation of a biochemistry analyzer in an accredited laboratory having a flexible scope is shown. A validation procedure including the evaluation of imprecision and bias of two Dimension Vista analysers 1500 was conducted. Comparability of patient results between one of them and the lately replaced Dimension RxL Max was evaluated. All studies followed the respective Clinical and Laboratory Standards Institute (CLSI) protocols. 30 chemistry assays were studied. Coefficients of variation, percent bias and total error were calculated for all tests and biological variation was considered as acceptance criteria. Quality control material and patient samples were used as test materials. Interchangeability of the results was established by processing forty patients' samples in both devices. 27 of the 30 studied parameters met allowable performance criteria. Sodium, chloride and magnesium did not fulfil acceptance criteria. Evidence of interchangeability of patient results was obtained for all parameters except magnesium, NT-proBNP, cTroponin I and C-reactive protein. A laboratory having a well structured and documented validation procedure can opt to get a flexible scope of accreditation. In addition, performing these activities prior to use on patient samples may evidence technical issues which must be corrected to minimize their impact on patient results.

Content validity of manual spinal palpatory exams - A systematic review

PubMed Central

Najm, Wadie I; Seffinger, Michael A; Mishra, Shiraz I; Dickerson, Vivian M; Adams, Alan; Reinsch, Sibylle; Murphy, Linda S; Goodman, Arnold F

2003-01-01

Background Many health care professionals use spinal palpatory exams as a primary and well-accepted part of the evaluation of spinal pathology. However, few studies have explored the validity of spinal palpatory exams. To evaluate the status of the current scientific evidence, we conducted a systematic review to assess the content validity of spinal palpatory tests used to identify spinal neuro-musculoskeletal dysfunction. Methods Review of eleven databases and a hand search of peer-reviewed literature, published between 1965–2002, was undertaken. Two blinded reviewers abstracted pertinent data from the retrieved papers, using a specially developed quality-scoring instrument. Five papers met the inclusion/exclusion criteria. Results Three of the five papers included in the review explored the content validity of motion tests. Two of these papers focused on identifying the level of fixation (decreased mobility) and one focused on range of motion. All three studies used a mechanical model as a reference standard. Two of the five papers included in the review explored the validity of pain assessment using the visual analogue scale or the subjects' own report as reference standards. Overall the sensitivity of studies looking at range of motion tests and pain varied greatly. Poor sensitivity was reported for range of motion studies regardless of the examiner's experience. A slightly better sensitivity (82%) was reported in one study that examined cervical pain. Conclusions The lack of acceptable reference standards may have contributed to the weak sensitivity findings. Given the importance of spinal palpatory tests as part of the spinal evaluation and treatment plan, effort is required by all involved disciplines to create well-designed and implemented studies in this area. PMID:12734016

Psychological Flexibility of Nurses in a Cancer Hospital: Preliminary Validation of a Chinese Version of the Work-related Acceptance and Action Questionnaire

PubMed Central

Xu, Xianghua; Liu, Xiangyu; Ou, Meijun; Xie, Chanjuan; Chen, Yongyi

2018-01-01

Objective: To translate the English work-related acceptance and action questionnaire (WAAQ), make cross-cultural adaptations, and examine its psychometric properties when used by Chinese oncology nurses. Methods: After translation, the psychometric properties of the Chinese WAAQ were analyzed among 417 nurses, and content validity was determined by six experts. Results: Item-level content validity index (CVI) values were between 0.83 and 1.00; scale-level CVI/universal agreement (S-CVI/UA) and S-CVI/average were 0.86 and 0.98, respectively, which implicated a good content validity. The correlation of the Chinese WAAQ with AAQ-II (rs = −0.247, P < 0.001) suggested criterion validity, and those with General Health Questionnaire-12 (−0.250, <0.001) and general self-efficacy scale (0.491, <0.001) and Utrecht work engagement scale (UWES) (0.439, <0.001) suggested convergent validity. Exploratory factor analysis identified a seven-item, one-factor structure of WAAQ. The Chinese version of WAAQ had high internal consistency (Cronbach's α = 0.920), with an item-total correlation coefficient of 0.702–0.828 (P < 0.05), split-half reliability of 0.933, and test-retest reliability of 0.772. Conclusions: The Chinese WAAQ is a reliable and valid tool for assessing psychological flexibility in Chinese oncology nurses. PMID:29379839

Quantum cryptography: Security criteria reexamined

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

Kaszlikowski, Dagomir; Liang, Y.C.; Englert, Berthold-Georg

2004-09-01

We find that the generally accepted security criteria are flawed for a whole class of protocols for quantum cryptography. This is so because a standard assumption of the security analysis, namely that the so-called square-root measurement is optimal for eavesdropping purposes, is not true in general. There are rather large parameter regimes in which the optimal measurement extracts substantially more information than the square-root measurement.

Developing an Acceptability Assessment of Preventive Dental Treatments

PubMed Central

Hyde, Susan; Gansky, Stuart A.; Gonzalez-Vargas, Maria J.; Husting, Sheila R.; Cheng, Nancy F.; Millstein, Susan G.; Adams, Sally H.

2012-01-01

Objectives Early childhood caries (ECC) is very prevalent among young Hispanic children. ECC is amenable to a variety of preventive procedures, yet many Hispanic families underutilize dental services. Acceptability research may assist in health care planning and resource allocation by identifying patient preferences among efficacious treatments with the goal of improving their utilization. The purposes of this study were (a) to develop a culturally competent acceptability assessment instrument, directed toward the caregivers of young Hispanic children, for five preventive dental treatments for ECC and (b) to test the instrument's reliability and validity. Methods An instrument of five standard treatments known to prevent ECC was developed, translated, reviewed by focus groups, and pilot tested, then tested for reliability. The instrument included illustrated cards, brief video clips, and samples of the treatments and was culturally appropriate for low-income Hispanic caregivers. In addition to determining the acceptability of the five treatments individually, the treatments were also presented as paired comparisons. Results Focus groups and debriefing interviews following the pilot tests established that the instrument has good face validity. The illustrated cards, product samples, and video demonstrations of the five treatments resulted in an instrument possessing good content validity. The instrument has good to excellent test–retest reliability, with identical time 1–time 2 responses for each of the five treatments 92 percent of the time (range 87 to 97 percent), and the same treatment of the paired comparisons preferred 75 percent of the time (range 61 to 90 percent). Conclusions The acceptability instrument described is reliable and valid and may be useful in program planning efforts to identify and increase the utilization of preferred ECC preventive treatments for target populations. PMID:18662256

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

PubMed

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, p<0.001), suggesting the IQR-to-median ratio of CAP would be an inappropriate validity parameter. In the derivation cohort, the IQR of CAP was associated with the accuracy of CAP (AUROC 0.86, 0.89 and 0.76 in patients with IQR of CAP <20 [15% of patients], 20-39 [51%], and ≥40dB/m [33%], respectively). Likewise, the AUROC of CAP in the validation cohort was 0.90 and 0.77 in patients with IQR of CAP <40 and ≥40dB/m, respectively (p=0.004). The accuracy of CAP in detecting grade 2 and 3 steatosis 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

The importance of having a flexible scope ISO 15189 accreditation and quality specifications based on biological variation – the case of validation of the biochemistry analyzer Dimension Vista

PubMed Central

Fernandez-Calle, Pilar; Pelaz, Sandra; Oliver, Paloma; Alcaide, Maria Jose; Gomez-Rioja, Ruben; Buno, Antonio; Iturzaeta, Jose Manuel

2013-01-01

Introduction Technological innovation requires the laboratories to ensure that modifications or incorporations of new techniques do not alter the quality of their results. In an ISO 15189 accredited laboratory, flexible scope accreditation facilitates the inclusion of these changes prior to accreditation body evaluation. A strategy to perform the validation of a biochemistry analyzer in an accredited laboratory having a flexible scope is shown. Materials and methods: A validation procedure including the evaluation of imprecision and bias of two Dimension Vista analysers 1500 was conducted. Comparability of patient results between one of them and the lately replaced Dimension RxL Max was evaluated. All studies followed the respective Clinical and Laboratory Standards Institute (CLSI) protocols. 30 chemistry assays were studied. Coefficients of variation, percent bias and total error were calculated for all tests and biological variation was considered as acceptance criteria. Quality control material and patient samples were used as test materials. Interchangeability of the results was established by processing forty patients’ samples in both devices. Results: 27 of the 30 studied parameters met allowable performance criteria. Sodium, chloride and magnesium did not fulfil acceptance criteria. Evidence of interchangeability of patient results was obtained for all parameters except magnesium, NT-proBNP, cTroponin I and C-reactive protein. Conclusions: A laboratory having a well structured and documented validation procedure can opt to get a flexible scope of accreditation. In addition, performing these activities prior to use on patient samples may evidence technical issues which must be corrected to minimize their impact on patient results. PMID:23457769

15 CFR Appendix A to Part 946 - National Weather Service Modernization Criteria

Code of Federal Regulations, 2010 CFR

2010-01-01

... specifically in Addendum I, Appendix D of the ASOS Site Component Commissioning Evaluation Package (the ASOS Package). Criteria: a. ASOS Acceptance Test: The site component acceptance test, which includes objective..., has been successfully completed in accordance with item 1a, p. D-2 of Appendix D of the ASOS Package...

15 CFR Appendix A to Part 946 - National Weather Service Modernization Criteria

Code of Federal Regulations, 2013 CFR

2013-01-01

... specifically in Addendum I, Appendix D of the ASOS Site Component Commissioning Evaluation Package (the ASOS Package). Criteria: a. ASOS Acceptance Test: The site component acceptance test, which includes objective..., has been successfully completed in accordance with item 1a, p. D-2 of Appendix D of the ASOS Package...

15 CFR Appendix A to Part 946 - National Weather Service Modernization Criteria

Code of Federal Regulations, 2012 CFR

2012-01-01

... specifically in Addendum I, Appendix D of the ASOS Site Component Commissioning Evaluation Package (the ASOS Package). Criteria: a. ASOS Acceptance Test: The site component acceptance test, which includes objective..., has been successfully completed in accordance with item 1a, p. D-2 of Appendix D of the ASOS Package...

15 CFR Appendix A to Part 946 - National Weather Service Modernization Criteria

Code of Federal Regulations, 2011 CFR

2011-01-01

... specifically in Addendum I, Appendix D of the ASOS Site Component Commissioning Evaluation Package (the ASOS Package). Criteria: a. ASOS Acceptance Test: The site component acceptance test, which includes objective..., has been successfully completed in accordance with item 1a, p. D-2 of Appendix D of the ASOS Package...

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

PubMed

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.

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

PubMed

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, p<.001) and to indices of sexual interest in children from phallometric testing (AUC=.70; 95% CI=.52-.89; p<.05) or a computerized assessment based on visual reaction time and self-report (AUC=.75; 95% CI=.62-.88; p<.005). Ever meeting the proposed DSM-5 "diagnosis" was similarly related to self-report (AUC=.84, 95% CI=.74-.94, p<.001) and to the two objective indices, with AUCs of .69 (95% CI=.53-.85; p<.05) and .77 (95% CI=.64-.89; p<.001), respectively. Because the pDSM-5 criteria did not produce significantly better reliability or validity results and users are more familiar with the current DSM-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.

Determining the Criteria and Their Weights for Medical Schools' Ranking: A National Consensus.

PubMed

Mojtahedzadeh, Rita; Mohammadi, Aeen; Kohan, Noushin; Gharib, Mitra; Zolfaghari, Mitra

2016-06-01

Delphi as a consensus development technique enables anonymous, systematic refinement of expert opinion with the aim of arriving at a combined or consensual position. In this study, we determined the criteria and their weights for Iranian Medical Schools' ranking through a Delphi process. An expert committee devised 13 proposed criteria with 32 indicators with their weights, which were arranged hierarchically in the form of a tree diagram. We used the Delphi technique to reach a consensus on these criteria and weights among the deans of 38 public Iranian medical schools. For this purpose, we devised and sent a questionnaire to schools and asked them to suggest or correct the criteria and their weights. We repeated this process in two rounds till all the schools reached an acceptable consensus on them. All schools reached a consensus on the set of 13 criteria and 30 indicators and their weights in three main contexts of education, research and facilities, and equipment which were used for Medical Schools' ranking. Using Delphi technique for devising the criteria and their weights in evaluation processes such as ranking makes their results more acceptable among universities.

Use of the FDA nozzle model to illustrate validation techniques in computational fluid dynamics (CFD) simulations.

PubMed

Hariharan, Prasanna; D'Souza, Gavin A; Horner, Marc; Morrison, Tina M; Malinauskas, Richard A; Myers, Matthew R

2017-01-01

A "credible" computational fluid dynamics (CFD) model has the potential to provide a meaningful evaluation of safety in medical devices. One major challenge in establishing "model credibility" is to determine the required degree of similarity between the model and experimental results for the model to be considered sufficiently validated. This study proposes a "threshold-based" validation approach that provides a well-defined acceptance criteria, which is a function of how close the simulation and experimental results are to the safety threshold, for establishing the model validity. The validation criteria developed following the threshold approach is not only a function of Comparison Error, E (which is the difference between experiments and simulations) but also takes in to account the risk to patient safety because of E. The method is applicable for scenarios in which a safety threshold can be clearly defined (e.g., the viscous shear-stress threshold for hemolysis in blood contacting devices). The applicability of the new validation approach was tested on the FDA nozzle geometry. The context of use (COU) was to evaluate if the instantaneous viscous shear stress in the nozzle geometry at Reynolds numbers (Re) of 3500 and 6500 was below the commonly accepted threshold for hemolysis. The CFD results ("S") of velocity and viscous shear stress were compared with inter-laboratory experimental measurements ("D"). The uncertainties in the CFD and experimental results due to input parameter uncertainties were quantified following the ASME V&V 20 standard. The CFD models for both Re = 3500 and 6500 could not be sufficiently validated by performing a direct comparison between CFD and experimental results using the Student's t-test. However, following the threshold-based approach, a Student's t-test comparing |S-D| and |Threshold-S| showed that relative to the threshold, the CFD and experimental datasets for Re = 3500 were statistically similar and the model could be

Diffusion of Educational Knowledge Through Journals: Gatekeepers' Selection Criteria

ERIC Educational Resources Information Center

Silverman, Robert J.

1978-01-01

Report is made of a survey of 248 editors representing scholarly, professional, association, and research journals in regard to their editorial role, criteria for accepting or rejecting manuscripts, and selection of editorial boards and reviewers. (Author/MJB)

49 CFR 611.11 - Local financial commitment criteria.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 7 2011-10-01 2011-10-01 false Local financial commitment criteria. 611.11... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION MAJOR CAPITAL INVESTMENT PROJECTS § 611.11 Local financial... proposed project is supported by an acceptable degree of local financial commitment, as required by section...

49 CFR 611.11 - Local financial commitment criteria.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 7 2010-10-01 2010-10-01 false Local financial commitment criteria. 611.11... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION MAJOR CAPITAL INVESTMENT PROJECTS § 611.11 Local financial... proposed project is supported by an acceptable degree of local financial commitment, as required by section...

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

PubMed

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.

The DSM diagnostic criteria for pedophilia.

PubMed

Blanchard, Ray

2010-04-01

This paper contains the author's report on pedophilia, submitted on June 2, 2008, to the work group charged with revising the diagnoses concerning sexual and gender identity disorders for the fifth edition of the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders (DSM). The author reviews the previously published criticisms and empirical research concerning the diagnostic criteria for pedophilia and presents criticism and relevant research of his own. The review shows that the DSM diagnostic criteria for pedophilia have repeatedly been criticized as unsatisfactory on logical or conceptual grounds, and that published empirical studies on the reliability and validity of these criteria have produced ambiguous results. It therefore seems that the current (i.e., DSM-IV-TR) diagnostic criteria need to be examined with an openness to major changes in the DSM-V.

Validation of the ROSSMAX blood pressure measuring monitor according to the European Society of Hypertension International Protocol for Validation of Blood Pressure Measuring Devices in Adults.

PubMed

O'Brien, Eoin; Atkins, Neil; Murphy, Anne; Lyons, Simon

2003-12-01

It is now accepted that blood pressure measuring devices should be subjected to an independent evaluation of their accuracy before they are marketed for clinical use. The results of validation of the ROSSMAX Blood Pressure Measuring Monitor for self-measurement according to the European Society of Hypertension International Protocol for Validation of Blood Pressure Measuring Devices in Adults are presented in this paper. Thirty-three subjects were recruited from among staff and patients at Beaumont Hospital, Dublin, Ireland. The ROSSMAX monitor was connected to the Sphygmocorder, an audiovisual system for validation, which records blood pressure on tape and video for later analysis. Nine sequential same-arm measurements between the device and a standard mercury sphygmomanometer were recorded using the Sphygmocorder. In phase 1, the ROSSMAX monitor produced 21 measurements within 5 mmHg, 31 within 10 mmHg and 38 within 15 mmHg for systolic blood pressure (SBP), and 36 within 5 mmHg, 43 within 10 mmHg and 45 within 15 mmHg for diastolic blood pressure (DBP). The mean differences were -5.6 (10.2) [mean (SD)] mmHg for SBP and -0.5 (4.5) mmHg for DBP. The ROSSMAX monitor failed to meet any of the criteria for SBP but comfortably passed all of the criteria for DBP. In phase 2.1, the ROSSMAX monitor had 51 measurements within 5 mmHg, 73 within 10 mmHg and 86 within 15 mmHg for SBP, and 71 measurements within 5 mmHg, 93 within 10 mmHg and 98 within 15 mmHg for DBP. The mean differences were -4.5. (9.5) mmHg for SBP and -1.8 (5.0) mmHg for DBP. The ROSSMAX monitor failed to meet any of the criteria for SBP but comfortably passed all of the criteria for DBP. In phase 2.2, 16 subjects had at least two of the differences lying within 5 mmHg and 10 subjects had no differences within 5 mmHg for SBP; 26 subjects had at least two of the differences falling within 5 mmHg and three subjects no differences within 5 mmHg for DBP. The ROSSMAX monitor failed to meet the criteria for SBP

Clinical criteria for psychiatric diagnosis and DSM-III.

PubMed

Spitzer, R L; Endicott, J; Robins, E

1975-11-01

The authors identify the differences in formal inclusion and exclusion criteria used to classify patient data into diagnoses as the largest source of diagnostic unreliability in psychiatry. They describe the efforts that have been made to reduce these differences, particularly the specified criteria approach to defining diagnostic categories, which was developed for research purposes. On the basis of studies showing that the use of specified criteria increases the reliability of diagnostic judgments, they suggest that including such criteria in the next edition of APA's Diagnostic and Statistical Manual of Mental Disorders (DSM-III) would improve the reliability and validity of routine psychiatric diagnosis.

Update of Standard Practices for New Method Validation in Forensic Toxicology.

PubMed

Wille, Sarah M R; Coucke, Wim; De Baere, Thierry; Peters, Frank T

2017-01-01

International agreement concerning validation guidelines is important to obtain quality forensic bioanalytical research and routine applications as it all starts with the reporting of reliable analytical data. Standards for fundamental validation parameters are provided in guidelines as those from the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), the German speaking Gesellschaft fur Toxikologie und Forensische Chemie (GTFCH) and the Scientific Working Group of Forensic Toxicology (SWGTOX). These validation parameters include selectivity, matrix effects, method limits, calibration, accuracy and stability, as well as other parameters such as carryover, dilution integrity and incurred sample reanalysis. It is, however, not easy for laboratories to implement these guidelines into practice as these international guidelines remain nonbinding protocols, that depend on the applied analytical technique, and that need to be updated according the analyst's method requirements and the application type. In this manuscript, a review of the current guidelines and literature concerning bioanalytical validation parameters in a forensic context is given and discussed. In addition, suggestions for the experimental set-up, the pros and cons of statistical approaches and adequate acceptance criteria for the validation of bioanalytical applications are given. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

29 CFR 1926.29 - Acceptable certifications.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Acceptable certifications. (a) Pressure vessels. Current and valid certification by an insurance company or... by an insurance company or regulatory authority attesting to the safe installation, inspection, and... types of pressure vessels and similar equipment are contained in subparts F and O of this part. ...

Donor understanding and attitudes about current and potential deferral criteria for high-risk sexual behavior.

PubMed

Goldman, Mindy; Yi, Qi-Long; Ye, Xibiao; Tessier, Lorna; O'Brien, Sheila F

2011-08-01

Few donor criteria are as contentious as the deferral of men who have had sex with men (MSM). We performed an anonymous donor survey to determine attitudes toward current screening and the feasibility and acceptability of adoption of alternate donor criteria for MSM. Donors who had successfully donated to Canadian Blood Services were randomly mailed an anonymous questionnaire several weeks after donation; there were 40,000 donors sampled, evenly split between first-time and repeat donors. The response rate was 45.5%. The vast majority of donors found the current screening questions and clinic environment acceptable. Attention to clinic educational materials was poor. A total of 53% felt that the MSM criteria should be changed; many were supportive of criteria based on specific behaviors rather than a period of abstinence. Gender-neutral questions such as number of sexual partners would result in deferral of large numbers of donors. Many donors would support a change in MSM deferral policy. Implementation of strategies based on donor attention to additional material would be challenging. Universal use of simple gender-neutral questions would result in very high donor loss and are therefore not an acceptable option. The acceptability and feasibility of various screening approaches should be explored further with both donors and advocacy groups. © 2011 American Association of Blood Banks.

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.

PubMed

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.

Identification of vascular patients at very high risk for recurrent cardiovascular events: validation of the current ACC/AHA very high risk criteria.

PubMed

van den Berg, M Johanneke; Bhatt, Deepak L; Kappelle, L Jaap; de Borst, Gert J; Cramer, Maarten J; van der Graaf, Yolanda; Steg, Ph Gabriel; Visseren, Frank L J

2017-11-14

To validate and assess performance of the current ACC/AHA very high risk criteria in patients with clinically manifest arterial disease. Data were used from the SMART study (n = 7216) and REACH Registry (n = 48 322), two prospective cohorts of patients with manifest atherosclerotic arterial disease. Prevalence and incidence rates of recurrent major adverse cardiovascular events (MACE) were calculated, according to the ACC/AHA VHR criteria (cardiovascular disease combined with diabetes, smoking, dyslipidaemia, and/or recent recurrent coronary events). Performance of the ACC/AHA criteria was compared with single very high risk factors in terms of C-statistics and Net Reclassification Index. All patients were at VHR according to the ESC guidelines (incidence of recurrent MACE in SMART was 2.4/100PY, with 95% CI 2.3-2.5/100PY and in REACH 5.1/100PY with 95% CI 5.0-5.3/100PY). In SMART 57% of the patients were at VHR according to the ACC/AHA criteria (incidence of recurrent MACE 2.7/100PY, 95% CI 2.5-2.9/100PY) and in REACH this was 64% (5.9/100PY, 95% CI 5.7-6.1/100PY). The C-statistic for the ACC/AHA VHR criteria was 0.53 in REACH and 0.54 in SMART. Very high risk factors with comparable or slightly better performance were eGFR < 45, polyvascular disease and age >70 years. Around two third of the patients meeting the ACC/AHA VHR criteria had a predicted 10-year risk of recurrent MACE <30%. The ACC/AHA VHR criteria have limited discriminative power. Identifying patients with clinically manifest arterial disease at VHR for recurrent vascular events using eGFR <45, polyvascular disease, or age >70 years performs as well as the ACC/AHA VHR criteria. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2017. For permissions, please email: journals.permissions@oup.com.

Children's Physical Activity While Gardening: Development of a Valid and Reliable Direct Observation Tool.

PubMed

Myers, Beth M; Wells, Nancy M

2015-04-01

Gardens are a promising intervention to promote physical activity (PA) and foster health. However, because of the unique characteristics of gardening, no extant tool can capture PA, postures, and motions that take place in a garden. The Physical Activity Research and Assessment tool for Garden Observation (PARAGON) was developed to assess children's PA levels, tasks, postures, and motions, associations, and interactions while gardening. PARAGON uses momentary time sampling in which a trained observer watches a focal child for 15 seconds and then records behavior for 15 seconds. Sixty-five children (38 girls, 27 boys) at 4 elementary schools in New York State were observed over 8 days. During the observation, children simultaneously wore Actigraph GT3X+ accelerometers. The overall interrater reliability was 88% agreement, and Ebel was .97. Percent agreement values for activity level (93%), garden tasks (93%), motions (80%), associations (95%), and interactions (91%) also met acceptable criteria. Validity was established by previously validated PA codes and by expected convergent validity with accelerometry. PARAGON is a valid and reliable observation tool for assessing children's PA in the context of gardening.

Harmonization of strategies for the validation of quantitative analytical procedures. A SFSTP proposal--Part I.

PubMed

Hubert, Ph; Nguyen-Huu, J-J; Boulanger, B; Chapuzet, E; Chiap, P; Cohen, N; Compagnon, P-A; Dewé, W; Feinberg, M; Lallier, M; Laurentie, M; Mercier, N; Muzard, G; Nivet, C; Valat, L

2004-11-15

This paper is the first part of a summary report of a new commission of the Société Française des Sciences et Techniques Pharmaceutiques (SFSTP). The main objective of this commission was the harmonization of approaches for the validation of quantitative analytical procedures. Indeed, the principle of the validation of theses procedures is today widely spread in all the domains of activities where measurements are made. Nevertheless, this simple question of acceptability or not of an analytical procedure for a given application, remains incompletely determined in several cases despite the various regulations relating to the good practices (GLP, GMP, ...) and other documents of normative character (ISO, ICH, FDA, ...). There are many official documents describing the criteria of validation to be tested, but they do not propose any experimental protocol and limit themselves most often to the general concepts. For those reasons, two previous SFSTP commissions elaborated validation guides to concretely help the industrial scientists in charge of drug development to apply those regulatory recommendations. If these two first guides widely contributed to the use and progress of analytical validations, they present, nevertheless, weaknesses regarding the conclusions of the performed statistical tests and the decisions to be made with respect to the acceptance limits defined by the use of an analytical procedure. The present paper proposes to review even the bases of the analytical validation for developing harmonized approach, by distinguishing notably the diagnosis rules and the decision rules. This latter rule is based on the use of the accuracy profile, uses the notion of total error and allows to simplify the approach of the validation of an analytical procedure while checking the associated risk to its usage. Thanks to this novel validation approach, it is possible to unambiguously demonstrate the fitness for purpose of a new method as stated in all regulatory

Understanding Patterns of Evolution Acceptance--A New Implementation of the Measure of Acceptance of the Theory of Evolution (MATE) with Midwestern University Students

ERIC Educational Resources Information Center

Romine, William L.; Walter, Emily M.; Bosse, Ephiram; Todd, Amber N.

2017-01-01

We validate the Measure of Acceptance of the Theory of Evolution (MATE) on undergraduate students using the Rasch model and utilize the MATE to explore qualitatively how students express their acceptance of evolution. At least 24 studies have used the MATE, most with the assumption that it is unidimensional. However, we found that the MATE is best…

Diagnosis of Guillain-Barré syndrome and validation of Brighton criteria.

PubMed

Fokke, Christiaan; van den Berg, Bianca; Drenthen, Judith; Walgaard, Christa; van Doorn, Pieter Antoon; Jacobs, Bart Casper

2014-01-01

Guillain-Barré syndrome is an acute polyradiculoneuropathy with a variable clinical presentation. Accurate diagnostic criteria are essential for patient care and research, including clinical trials and vaccine safety studies. Several diagnostic criteria for Guillain-Barré syndrome have been proposed, including the recent set by the Brighton Collaboration. In the present study we describe in detail the key diagnostic features required to meet these Brighton criteria in a study population of 494 adult patients with Guillain-Barré syndrome, previously included in therapeutic and observational studies. The patients had a median age of 53 years (interquartile range 36-66 years) and males slightly predominated (56%). All patients developed bilateral limb weakness which generally involved both upper and lower extremities. The weakness remained restricted to the legs in 6% and to the arms in 1% of the patients. Decreased reflexes in paretic arms or legs were found initially in 91% of patients and in all patients during follow-up. Ten (2%) patients however showed persistence of normal reflexes in paretic arms. Disease nadir was reached within 2 weeks in 80%, within 4 weeks in 97% and within 6 weeks in all patients. A monophasic disease course occurred in 95% of patients, of whom 10% had a treatment-related fluctuation. A clinical deterioration after 8 weeks of onset of weakness occurred in 23 (5%) patients. Cerebrospinal fluid was examined in 474 (96%) patients. A mild pleocytosis (5 to 50 cells/μl) was found in 15%, and none had more than 50 cells/μl. An increased cerebrospinal fluid protein concentration was found only in 64% of patients, highly dependent on the timing of the lumbar puncture after onset of weakness (49% at the first day to 88% after 2 weeks). Nerve electrophysiology was compatible with the presence of a neuropathy in 99% of patients, but only 59% fulfilled the current criteria for a distinct subtype of Guillain-Barré syndrome. Patients with a

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

PubMed

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

Development and validation of the patient evaluation scale (PES) for primary health care in Nigeria.

PubMed

Ogaji, Daprim S; Giles, Sally; Daker-White, Gavin; Bower, Peter

2017-03-01

Questionnaires developed for patient evaluation of the quality of primary care are often focussed on primary care systems in developed countries. Aim To report the development and validation of the patient evaluation scale (PES) designed for use in the Nigerian primary health care context. An iterative process was used to develop and validate the questionnaire using patients attending 28 primary health centres across eight states in Nigeria. The development involved literature review, patient interviews, expert reviews, cognitive testing with patients and waves of quantitative cross-sectional surveys. The questionnaire's content validity, internal structures, acceptability, reliability and construct validity are reported. Findings The full and shortened version of PES with 27 and 18 items, respectively, were developed through these process. The low item non-response from the serial cross-sectional surveys depicts questionnaire's acceptability among the local population. PES-short form (SF) has Cronbach's α of 0.87 and three domains (codenamed 'facility', 'organisation' and 'health care') with Cronbach's αs of 0.78, 0.79 and 0.81, respectively. Items in the multi-dimensional questionnaire demonstrated adequate convergent and discriminant properties. PES-SF scores show significant positive correlation with scores of the full PES and also discriminated population groups in support of a priori hypotheses. The PES and PES-SF contain items that are relevant to the needs of patients in Nigeria. The good measurement properties of the questionnaire demonstrates its potential usefulness for patient-focussed quality improvement activities in Nigeria. There is still need to translate these questionnaires into major languages in Nigeria and assess their validity against external quality criteria.

The number of lung transplants can be safely doubled using extended criteria donors; a single-center review.

PubMed

Meers, Caroline; Van Raemdonck, Dirk; Verleden, Geert M; Coosemans, Willy; Decaluwe, Herbert; De Leyn, Paul; Nafteux, Philippe; Lerut, Toni

2010-06-01

Relaxing the standard lung donor criteria may significantly increase the reported 15% organ yield but post-transplant recipient outcome should be carefully monitored. Charts from all consecutive deceased organ donors within our hospital network were reviewed over a 2-year period. Reasons for lung refusals and number of lungs transplanted were analysed. Hospital outcome including early recipient survival was compared between standard- and extended criteria donors. Out of 283 referrals, 164 (58%) qualified as donor of any organ. The majority (65.9%) of these effective donors were declined for lung donation because of chest X-ray abnormalities (20%), age >70 years (13%), poor oxygenation (10%), or aspiration (9%). Out of 56 (34.1%) accepted lung donors, 50 transplants were performed at our center, 23 from standard criteria donors versus 27 from extended criteria donors. There were no significant differences in hospital outcome and in early survival between lung recipients from both donor groups. Lung acceptance rate (34.1%) in our donor network is 10-20% higher than reported figures. The number of lung transplants in our center doubled by accepting extended criteria donors. This policy did not negatively influence our results after lung transplantation.

Validity and Reliability of Dermoscopic Criteria Used to Differentiate Nevi From Melanoma

PubMed Central

Carrera, Cristina; Marchetti, Michael A.; Dusza, StephenW.; Argenziano, Giuseppe; Braun, Ralph P.; Halpern, Allan C.; Jaimes, Natalia; Kittler, Harald J.; Malvehy, Josep; Menzies, Scott W.; Pellacani, Giovanni; Puig, Susana; Rabinovitz, Harold S.; Scope, Alon; Soyer, H. Peter; Stolz, Wilhelm; Hofmann-Wellenhof, Rainer; Zalaudek, Iris; Marghoob, Ashfaq A.

2017-01-01

IMPORTANCE The comparative diagnostic performance of dermoscopic algorithms and their individual criteria are not well studied. OBJECTIVES To analyze the discriminatory power and reliability of dermoscopic criteria used in melanoma detection and compare the diagnostic accuracy of existing algorithms. DESIGN, SETTING, AND PARTICIPANTS This was a retrospective, observational study of 477 lesions (119 melanomas [24.9%] and 358 nevi [75.1%]), which were divided into 12 image sets that consisted of 39 or 40 images per set. A link on the International Dermoscopy Society website from January 1, 2011, through December 31, 2011, directed participants to the study website. Data analysis was performed from June 1, 2013, through May 31, 2015. Participants included physicians, residents, and medical students, and there were no specialty-type or experience-level restrictions. Participants were randomly assigned to evaluate 1 of the 12 image sets. MAIN OUTCOMES AND MEASURES Associations with melanoma and intraclass correlation coefficients (ICCs) were evaluated for the presence of dermoscopic criteria. Diagnostic accuracy measures were estimated for the following algorithms: the ABCD rule, the Menzies method, the 7-point checklist, the 3-point checklist, chaos and clues, and CASH (color, architecture, symmetry, and homogeneity). RESULTS A total of 240 participants registered, and 103 (42.9%) evaluated all images. The 110 participants (45.8%) who evaluated fewer than 20 lesions were excluded, resulting in data from 130 participants (54.2%), 121 (93.1%) of whom were regular dermoscopy users. Criteria associated with melanoma included marked architectural disorder (odds ratio [OR], 6.6; 95% CI, 5.6–7.8), pattern asymmetry (OR, 4.9; 95% CI, 4.1–5.8), nonorganized pattern (OR, 3.3; 95% CI, 2.9–3.7), border score of 6 (OR, 3.3; 95% CI, 2.5–4.3), and contour asymmetry (OR, 3.2; 95% CI, 2.7–3.7) (P < .001 for all). Most dermoscopic criteria had poor to fair interobserver

A Systematic Review Comparing the Acceptability, Validity and Concordance of Discrete Choice Experiments and Best-Worst Scaling for Eliciting Preferences in Healthcare.

PubMed

Whitty, Jennifer A; Oliveira Gonçalves, Ana Sofia

2018-06-01

The aim of this study was to compare the acceptability, validity and concordance of discrete choice experiment (DCE) and best-worst scaling (BWS) stated preference approaches in health. A systematic search of EMBASE, Medline, AMED, PubMed, CINAHL, Cochrane Library and EconLit databases was undertaken in October to December 2016 without date restriction. Studies were included if they were published in English, presented empirical data related to the administration or findings of traditional format DCE and object-, profile- or multiprofile-case BWS, and were related to health. Study quality was assessed using the PREFS checklist. Fourteen articles describing 12 studies were included, comparing DCE with profile-case BWS (9 studies), DCE and multiprofile-case BWS (1 study), and profile- and multiprofile-case BWS (2 studies). Although limited and inconsistent, the balance of evidence suggests that preferences derived from DCE and profile-case BWS may not be concordant, regardless of the decision context. Preferences estimated from DCE and multiprofile-case BWS may be concordant (single study). Profile- and multiprofile-case BWS appear more statistically efficient than DCE, but no evidence is available to suggest they have a greater response efficiency. Little evidence suggests superior validity for one format over another. Participant acceptability may favour DCE, which had a lower self-reported task difficulty and was preferred over profile-case BWS in a priority setting but not necessarily in other decision contexts. DCE and profile-case BWS may be of equal validity but give different preference estimates regardless of the health context; thus, they may be measuring different constructs. Therefore, choice between methods is likely to be based on normative considerations related to coherence with theoretical frameworks and on pragmatic considerations related to ease of data collection.

Subtyping attention-deficit/hyperactivity disorder using temperament dimensions: toward biologically based nosologic criteria.

PubMed

Karalunas, Sarah L; Fair, Damien; Musser, Erica D; Aykes, Kamari; Iyer, Swathi P; Nigg, Joel T

2014-09-01

Psychiatric nosology is limited by behavioral and biological heterogeneity within existing disorder categories. The imprecise nature of current nosologic distinctions limits both mechanistic understanding and clinical prediction. We demonstrate an approach consistent with the National Institute of Mental Health Research Domain Criteria initiative to identify superior, neurobiologically valid subgroups with better predictive capacity than existing psychiatric categories for childhood attention-deficit/hyperactivity disorder (ADHD). To refine subtyping of childhood ADHD by using biologically based behavioral dimensions (i.e., temperament), novel classification algorithms, and multiple external validators. A total of 437 clinically well-characterized, community-recruited children, with and without ADHD, participated in an ongoing longitudinal study. Baseline data were used to classify children into subgroups based on temperament dimensions and examine external validators including physiological and magnetic resonance imaging measures. One-year longitudinal follow-up data are reported for a subgroup of the ADHD sample to address stability and clinical prediction. Parent/guardian ratings of children on a measure of temperament were used as input features in novel community detection analyses to identify subgroups within the sample. Groups were validated using 3 widely accepted external validators: peripheral physiological characteristics (cardiac measures of respiratory sinus arrhythmia and pre-ejection period), central nervous system functioning (via resting-state functional connectivity magnetic resonance imaging), and clinical outcomes (at 1-year longitudinal follow-up). The community detection algorithm suggested 3 novel types of ADHD, labeled as mild (normative emotion regulation), surgent (extreme levels of positive approach-motivation), and irritable (extreme levels of negative emotionality, anger, and poor soothability). Types were independent of existing

Hair testing for cocaine and metabolites by GC/MS: criteria to quantitatively assess cocaine use.

PubMed

López-Guarnido, O; Álvarez, I; Gil, F; Rodrigo, L; Cataño, H C; Bermejo, A M; Tabernero, M J; Pla, A; Hernández, A F

2013-08-01

A simple, rapid and sensitive method has been developed and validated for the determination of cocaine and its main metabolites (benzoylecgonine and cocaethylene) in human hair. The method involved solid-phase extraction with an Oasis HLB extraction cartridge and subsequent analysis by GC/MS. The limit of detection was 0.01 ng mg(-1) for cocaine, 0.04 for benzoylecgonine and 0.03 for cocaethylene. The method validation included linearity (with a correlation coefficient >0.99 over the range 0.2-50 ng mg(-1) ), intra- and inter-day precision (always lower than 12%) and accuracy (mean relative error always below 17%) to meet the bioanalytical acceptance criteria. The procedure was further applied to 40 hair samples from self-reported cocaine users arrested by the police who provided a positive urine-analysis for cocaine, and was demonstrated to be suitable for its application in forensic toxicology. New approaches were raised to detect false-negative results that allow a better interpretation of hair testing results. Copyright © 2012 John Wiley & Sons, Ltd.

Are the current notification criteria for Lyme borreliosis in Norway suitable? Results of an evaluation of Lyme borreliosis surveillance in Norway, 1995-2013.

PubMed

MacDonald, Emily; Vestrheim, Didrik Frimann; White, Richard A; Konsmo, Kirstin; Lange, Heidi; Aase, Audun; Nygård, Karin; Stefanoff, Pawel; Aaberge, Ingeborg; Vold, Line

2016-08-05

differences in testing practices and low acceptability of the notification criteria. Given the challenges associated with diagnosing Lyme borreliosis, the selected notification criteria should be closely linked with the purpose of the surveillance system. Restricting reportable Lyme borreliosis to neuroborreliosis may increase validity, while a more sensitive case definition (potentially including erythema migrans) may better reflect the true burden of disease. We recommend revising the current notification criteria in Norway to ensure that they are unambiguous for clinicians and laboratories.

Proposed Diagnostic Criteria for Smartphone Addiction

PubMed Central

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

2016-01-01

Background 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. Methods 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. Results 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. Conclusion 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. PMID:27846211

Proposed Diagnostic Criteria for Smartphone Addiction.

PubMed

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.

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

PubMed

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.

Attitudes among transplant professionals regarding shifting paradigms in eligibility criteria for live kidney donation.

PubMed

Lafranca, Jeffrey A; Spoon, Emerentia Q W; van de Wetering, Jacqueline; IJzermans, Jan N M; Dor, Frank J M F

2017-01-01

The transplant community increasingly accepts extended criteria live kidney donors, however, great (geographical) differences are present in policies regarding the acceptance of these donors, and guidelines do not offer clarity. The aim of this survey was to reveal these differences and to get an insight in both centre policies as well as personal beliefs of transplant professionals. An online survey was sent to 1128 ESOT-members. Questions were included about several extended donor criteria; overweight/obesity, older age, vascular multiplicity, minors as donors and comorbidities; hypertension, impaired fasting glucose, kidney stones, malignancies and renal cysts. Comparisons were made between transplant centres of three regions in Europe and between Europe and other countries worldwide. 331 questionnaires were completed by professionals from 55 countries. Significant differences exist between regions in Europe in acceptance of donors with several extended criteria. Median refusal rate for potential live donors is 15%. Furthermore, differences are seen regarding pre-operative work-up, both in specialists who perform screening as in preoperative imaging. Remarkably, 23.4% of transplant professionals sometimes deviate from their centre policy, resulting in more or less comparable personal beliefs regarding extended criteria. Variety is seen, proving the need for a standardized approach in selection, preferably evidence based.

Attitudes among transplant professionals regarding shifting paradigms in eligibility criteria for live kidney donation

PubMed Central

Spoon, Emerentia Q. W.; van de Wetering, Jacqueline; IJzermans, Jan N. M.; Dor, Frank J. M. F.

2017-01-01

Background The transplant community increasingly accepts extended criteria live kidney donors, however, great (geographical) differences are present in policies regarding the acceptance of these donors, and guidelines do not offer clarity. The aim of this survey was to reveal these differences and to get an insight in both centre policies as well as personal beliefs of transplant professionals. Methods An online survey was sent to 1128 ESOT-members. Questions were included about several extended donor criteria; overweight/obesity, older age, vascular multiplicity, minors as donors and comorbidities; hypertension, impaired fasting glucose, kidney stones, malignancies and renal cysts. Comparisons were made between transplant centres of three regions in Europe and between Europe and other countries worldwide. Results 331 questionnaires were completed by professionals from 55 countries. Significant differences exist between regions in Europe in acceptance of donors with several extended criteria. Median refusal rate for potential live donors is 15%. Furthermore, differences are seen regarding pre-operative work-up, both in specialists who perform screening as in preoperative imaging. Conclusions Remarkably, 23.4% of transplant professionals sometimes deviate from their centre policy, resulting in more or less comparable personal beliefs regarding extended criteria. Variety is seen, proving the need for a standardized approach in selection, preferably evidence based. PMID:28732093

Severe community-acquired pneumonia. Assessment of severity criteria.

PubMed

Ewig, S; Ruiz, M; Mensa, J; Marcos, M A; Martinez, J A; Arancibia, F; Niederman, M S; Torres, A

1998-10-01

The purpose of the study was to validate the criteria used in the guidelines of the American Thoracic Society (ATS) for severe community-acquired pneumonia (CAP). Severe pneumonia was defined as admission to the intensive care unit (ICU). Overall 331 nonsevere (84%) and 64 severe cases (16%) of CAP were prospectively studied. Mortality was 19 of 395 (5%) and 19 of 64 (30%), respectively. Single severity criteria as well as the ATS definition of severe pneumonia were assessed calculating the operative indices. A modified prediction rule including minor (baseline) and major (baseline or evolutionary) criteria was derived. Single minor criteria at admission had a low sensitivity and positive predictive value. Defining severe pneumonia according to the ATS guidelines had a high sensitivity (98%). However, specificity and positive predictive value were low (32% and 24%, respectively). A modified prediction rule (presence of two or three minor criteria [systolic blood pressure < 90 mm Hg, multilobar involvement, PaO2/FIO2 < 250] or one of two major criteria [requirement of mechanical ventilation, presence of septic shock]) had a sensitivity of 78%, a specificity of 94%, a positive predictive value of 75%, and a negative predictive value of 95%. The ATS definition of severe pneumonia was highly sensitive but insufficiently specific and had a low positive predictive value. Our suggested modified rule had a more balanced performance and, if validated in an independent population, may represent a more accurate definition of severe CAP.

Development and validation of a measure of food choice values.

PubMed

Lyerly, Jordan E; Reeve, Charlie L

2015-06-01

Food choice values (FCVs) are factors that individuals consider when deciding which foods to purchase and/or consume. Given the potentially important implications for health, it is critical for researchers to have access to a validated measure of FCV. Though there is an existing measure of FCV, this measure was developed 20 years ago and recent research suggests additional FCVs exist that are not included in this measure. A series of four studies was conducted to develop a new expanded measure of FCV. An eight-factor model of FCV was supported and confirmed. In aggregate, results from the four studies indicate that the measure is content valid, and has internally consistent scales that also demonstrated acceptable temporal stability and convergent validity. In addition, the eight scales of the measures were independent of social desirability, met criteria for measurement invariance across income groups, and predicted dietary intake. The development of this new measure of FCV may be useful for researchers examining FCVs (FCVs) in the future, as well as for use in intervention and prevention efforts targeting dietary choices. Copyright © 2015 Elsevier Ltd. All rights reserved.

Application of a framework to assess the usefulness of alternative sepsis criteria

PubMed Central

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; Watson, R. Scott; Angus, Derek C.

2016-01-01

The current definition for sepsis is life-threatening, acute organ dysfunction secondary to a dysregulated host response to infection. Criteria to operationalize this definition can be judged by 6 domains of usefulness (reliability; content, construct and criterion validity, measurement burden, and timeliness). The relative importance of these 6 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 4-fold and mortality 3-fold. Predictably, clinical care criteria, which emphasized timeliness and low burden and therefore used vital signs and routine laboratory tests, had the highest 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. PMID:26901560

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

PubMed

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.

Alternatives to animal testing: research, trends, validation, regulatory acceptance.

PubMed

Huggins, Jane

2003-01-01

Current trends and issues in the development of alternatives to the use of animals in biomedical experimentation are discussed in this position paper. Eight topics are considered and include refinement of acute toxicity assays; eye corrosion/irritation alternatives; skin corrosion/irritation alternatives; contact sensitization alternatives; developmental/reproductive testing alternatives; genetic engineering (transgenic) assays; toxicogenomics; and validation of alternative methods. The discussion of refinement of acute toxicity assays is focused primarily on developments with regard to reduction of the number of animals used in the LD(50) assay. However, the substitution of humane endpoints such as clinical signs of toxicity for lethality in these assays is also evaluated. Alternative assays for eye corrosion/irritation as well as those for skin corrosion/irritation are described with particular attention paid to the outcomes, both successful and unsuccessful, of several validation efforts. Alternative assays for contact sensitization and developmental/reproductive toxicity are presented as examples of methods designed for the examination of interactions between toxins and somewhat more complex physiological systems. Moreover, genetic engineering and toxicogenomics are discussed with an eye toward the future of biological experimentation in general. The implications of gene manipulation for research animals, specifically, are also examined. Finally, validation methods are investigated as to their effectiveness, or lack thereof, and suggestions for their standardization and improvement, as well as implementation are reviewed.

Applying the Technology Acceptance Model and flow theory to Cyworld user behavior: implication of the Web2.0 user acceptance.

PubMed

Shin, Dong-Hee; Kim, Won-Yong; Kim, Won-Young

2008-06-01

This study explores attitudinal and behavioral patterns when using Cyworld by adopting an expanded Technology Acceptance Model (TAM). A model for Cyworld acceptance is used to examine how various factors modified from the TAM influence acceptance and its antecedents. This model is examined through an empirical study involving Cyworld users using structural equation modeling techniques. The model shows reasonably good measurement properties and the constructs are validated. The results not only confirm the model but also reveal general factors applicable to Web2.0. A set of constructs in the model can be the Web2.0-specific factors, playing as enhancing factor to attitudes and intention.

Dysplastic naevus: histological criteria and their inter-observer reproducibility.

PubMed

Hastrup, N; Clemmensen, O J; Spaun, E; Søndergaard, K

1994-06-01

Forty melanocytic lesions were examined in a pilot study, which was followed by a final series of 100 consecutive melanocytic lesions, in order to evaluate the inter-observer reproducibility of the histological criteria proposed for the dysplastic naevus. The specimens were examined in a blind fashion by four observers. Analysis by kappa statistics showed poor reproducibility of nuclear features, while reproducibility of architectural features was acceptable, improving in the final series. Consequently, we cannot apply the combined criteria of cytological and architectural features with any confidence in the diagnosis of dysplastic naevus, and, until further studies have documented that architectural criteria alone will suffice in the diagnosis of dysplastic naevus, we, as pathologists, shall avoid this term.

Children acceptance of laser dental treatment

NASA Astrophysics Data System (ADS)

Lazea, Andreea; Todea, Carmen

2016-03-01

Objectives: To evaluate the dental anxiety level and the degree of acceptance of laser assisted pedodontic treatments from the children part. Also, we want to underline the advantages of laser use in pediatric dentistry, to make this technology widely used in treating dental problems of our children patients. Methods: Thirty pediatric dental patients presented in the Department of Pedodontics, University of Medicine and Pharmacy "Victor Babeş", Timişoara were evaluated using the Wong-Baker pain rating scale, wich was administered postoperatory to all patients, to assess their level of laser therapy acceptance. Results: Wong-Baker faces pain rating scale (WBFPS) has good validity and high specificity; generally it's easy for children to use, easy to compare and has good feasibility. Laser treatment has been accepted and tolerated by pediatric patients for its ability to reduce or eliminate pain. Around 70% of the total sample showed an excellent acceptance of laser dental treatment. Conclusions: Laser technology is useful and effective in many clinical situations encountered in pediatric dentistry and a good level of pacient acceptance is reported during all laser procedures on hard and soft tissues.

Validation of Gujarati Version of ABILOCO-Kids Questionnaire

PubMed Central

Diwan, Jasmin; Patel, Pankaj; Bansal, Ankita B.

2015-01-01

Background ABILOCO-Kids is a measure of locomotion ability for children with cerebral palsy (CP) aged 6 to 15 years & is available in English & French. Aim To validate the Gujarati version of ABILOCO-Kids questionnaire to be used in clinical research on Gujarati population. Materials and Methods ABILOCO-Kids questionnaire was translated into Gujarati from English using forward-backward-forward method. To ensure face & content validity of Gujarati version using group consensus method, each item was examined by group of experts having mean experience of 24.62 years in field of paediatric and paediatric physiotherapy. Each item was analysed for content, meaning, wording, format, ease of administration & scoring. Each item was scored by expert group as either accepted, rejected or accepted with modification. Procedure was continued until 80% of consensus for all items. Concurrent validity was examined on 55 children with Cerebral Palsy (6-15 years) of all Gross Motor Functional Classification System (GMFCS) level & all clinical types by correlating score of ABILOCO-Kids with Gross Motor Functional Measure & GMFCS. Result In phase 1 of validation, 16 items were accepted as it is; 22 items accepted with modification & 3 items went for phase 2 validation. For concurrent validity, highly significant positive correlation was found between score of ABILOCO-Kids & total GMFM (r=0.713, p<0.005) & highly significant negative correlation with GMFCS (r= -0.778, p<0.005). Conclusion Gujarati translated version of ABILOCO-Kids questionnaire has good face & content validity as well as concurrent validity which can be used to measure caregiver reported locomotion ability in children with CP. PMID:26557603

Validation of Gujarati Version of ABILOCO-Kids Questionnaire.

PubMed

Diwan, Shraddha; Diwan, Jasmin; Patel, Pankaj; Bansal, Ankita B

2015-10-01

ABILOCO-Kids is a measure of locomotion ability for children with cerebral palsy (CP) aged 6 to 15 years & is available in English & French. To validate the Gujarati version of ABILOCO-Kids questionnaire to be used in clinical research on Gujarati population. ABILOCO-Kids questionnaire was translated into Gujarati from English using forward-backward-forward method. To ensure face & content validity of Gujarati version using group consensus method, each item was examined by group of experts having mean experience of 24.62 years in field of paediatric and paediatric physiotherapy. Each item was analysed for content, meaning, wording, format, ease of administration & scoring. Each item was scored by expert group as either accepted, rejected or accepted with modification. Procedure was continued until 80% of consensus for all items. Concurrent validity was examined on 55 children with Cerebral Palsy (6-15 years) of all Gross Motor Functional Classification System (GMFCS) level & all clinical types by correlating score of ABILOCO-Kids with Gross Motor Functional Measure & GMFCS. In phase 1 of validation, 16 items were accepted as it is; 22 items accepted with modification & 3 items went for phase 2 validation. For concurrent validity, highly significant positive correlation was found between score of ABILOCO-Kids & total GMFM (r=0.713, p<0.005) & highly significant negative correlation with GMFCS (r= -0.778, p<0.005). Gujarati translated version of ABILOCO-Kids questionnaire has good face & content validity as well as concurrent validity which can be used to measure caregiver reported locomotion ability in children with CP.

Genetic improvement of mastitis resistance: validation of somatic cell score and clinical mastitis as selection criteria.

PubMed

Odegård, J; Klemetsdal, G; Heringstad, B

2003-12-01

Mean daughter deviations for clinical mastitis among second-crop daughters were regressed on predicted transmitting abilities for clinical mastitis and lactation mean somatic cell score in first-crop daughters to validate the predictive ability of these traits as selection criteria for reduced incidence of clinical mastitis. A total of 321 sires had 684,897 second-crop daughters, while predicted transmitting abilities were calculated for 2159 sires, based on 495,681 records of first-crop daughters. Predictive ability, as a measure of efficiency of selection, was 23 to 43% higher for clinical mastitis than for lactation mean somatic cell score. Compared to single-trait selection, predictive ability improved 8 to 13% from utilizing information on both traits. The relative weight that should be assigned to standardized predicted transmitting abilities from univariate genetic analyses were 60 to 67% for clinical mastitis and 33 to 40% for lactation mean somatic cell score. No significant nonlinear genetic relationship between the two traits was found.

Performance measures and criteria for hydrologic and water quality models

USDA-ARS?s Scientific Manuscript database

Performance measures and criteria are essential for model calibration and validation. This presentation will include a summary of one of the papers that will be included in the 2014 Hydrologic and Water Quality Model Calibration & Validation Guidelines Special Collection of the ASABE Transactions. T...

Trauma system evaluation in developing countries: applicability of American College of Surgeons/Committee on Trauma (ACS/COT) basic criteria.

PubMed

Latifi, Rifat; Ziemba, Michelle; Leppäniemi, Ari; Dasho, Erion; Dogjani, Agron; Shatri, Zhaneta; Kociraj, Agim; Oldashi, Fatos; Shosha, Lida

2014-08-01

Trauma continues to be a major health problem worldwide, particularly in the developing world, with high mortality and morbidity. Yet most developing countries lack an organized trauma system. Furthermore, developing countries do not have in place any accreditation process for trauma centers; thus, no accepted standard assessment tools exist to evaluate their trauma services. The aims of this study were to evaluate the trauma system in Albania, using the basic trauma criteria of the American College of Surgeons/Committee on Trauma (ACS/COT) as assessment tools, and to provide the Government with a situational analysis relative to these criteria. We used the ACS/COT basic criteria as assessment tools to evaluate the trauma system in Albania. We conducted a series of semi-structured interviews, unstructured interviews, and focus groups with all stakeholders at the Ministry of Health, at the University Trauma Hospital (UTH) based in Tirana (the capital city), and at ten regional hospitals across the country. Albania has a dedicated national trauma center that serves as the only tertiary center, plus ten regional hospitals that provide some trauma care. However, overall, its trauma system is in need of major reforms involving all essential elements in order to meet the basic requirements of a structured trauma system. The ACS/COT basic criteria can be used as assessment tools to evaluate trauma care in developing countries. Further studies are needed in other developing countries to validate the applicability of these criteria.

Use of the FDA nozzle model to illustrate validation techniques in computational fluid dynamics (CFD) simulations

PubMed Central

Hariharan, Prasanna; D’Souza, Gavin A.; Horner, Marc; Morrison, Tina M.; Malinauskas, Richard A.; Myers, Matthew R.

2017-01-01

A “credible” computational fluid dynamics (CFD) model has the potential to provide a meaningful evaluation of safety in medical devices. One major challenge in establishing “model credibility” is to determine the required degree of similarity between the model and experimental results for the model to be considered sufficiently validated. This study proposes a “threshold-based” validation approach that provides a well-defined acceptance criteria, which is a function of how close the simulation and experimental results are to the safety threshold, for establishing the model validity. The validation criteria developed following the threshold approach is not only a function of Comparison Error, E (which is the difference between experiments and simulations) but also takes in to account the risk to patient safety because of E. The method is applicable for scenarios in which a safety threshold can be clearly defined (e.g., the viscous shear-stress threshold for hemolysis in blood contacting devices). The applicability of the new validation approach was tested on the FDA nozzle geometry. The context of use (COU) was to evaluate if the instantaneous viscous shear stress in the nozzle geometry at Reynolds numbers (Re) of 3500 and 6500 was below the commonly accepted threshold for hemolysis. The CFD results (“S”) of velocity and viscous shear stress were compared with inter-laboratory experimental measurements (“D”). The uncertainties in the CFD and experimental results due to input parameter uncertainties were quantified following the ASME V&V 20 standard. The CFD models for both Re = 3500 and 6500 could not be sufficiently validated by performing a direct comparison between CFD and experimental results using the Student’s t-test. However, following the threshold-based approach, a Student’s t-test comparing |S-D| and |Threshold-S| showed that relative to the threshold, the CFD and experimental datasets for Re = 3500 were statistically similar and

Evaluating Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Posttraumatic Stress Disorder Diagnostic Criteria in Older Children and Adolescents.

PubMed

Mikolajewski, Amy J; Scheeringa, Michael S; Weems, Carl F

2017-05-01

Few studies have assessed how the diagnostic criteria for posttraumatic stress disorder (PTSD) apply to older children and adolescents. With the introduction of a new, developmentally sensitive set of criteria for very young children (age 6 years and younger) in Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5), this raises new questions about the validity of the criteria for older children and adolescents. The current study investigated how diagnostic changes in DSM-5 impact diagnosis rates in 7-18-year olds. PTSD, impairment, and comorbid psychopathology were assessed in 135 trauma-exposed, treatment-seeking participants. Children (ages 7-12) were examined separately from adolescents (ages 13-18) to assess for potential developmental differences. A significantly higher proportion of 7-12-year-old children met criteria for DSM-5 diagnosis (53%) compared to Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) (37%). However, among 13-18-year-old adolescents, the proportions diagnosed with DSM-5 (73%) and DSM-IV (74%) did not differ. Participants who met criteria for DSM-5 only (17%) did not differ from those diagnosed with DSM-IV in terms impairment or comorbidity. Using the newly accepted age 6 years and younger criteria resulted in a significantly higher proportion of 7-12-year-old (but not 13-18-year olds) children meeting criteria compared to DSM-IV or DSM-5. However, these children showed less impairment and comorbidity than those diagnosed with DSM-IV. These findings suggest that DSM-5 criteria may be more developmentally sensitive than DSM-IV criteria, and may lead to higher prevalence rates of PTSD for 7-12-year-old children, but not for adolescents. Using the very young children criteria for 7-12-year-old children may further increase prevalence, but capture children with less severe psychopathology.

Guillain–Barré Syndrome in India: Population-based validation of the Brighton criteria

PubMed Central

Mateen, Farrah J.; Cornblath, David R.; Jafari, Hamid; Shinohara, Russell T.; Khandit, Devendra; Ahuja, Bina; Bahl, Sunil; Sutter, Roland W.

2013-01-01

Objective Case definitions of GBS were recently developed in response to the 2009 H1N1 vaccination programme but have undergone limited field testing. We validate the sensitivity of the Brighton Working Group case definitions for Guillain–Barré Syndrome (GBS) using a population-based cohort in India. Methods The National Polio Surveillance Unit of India actively collects all cases of acute flaccid paralysis (AFP) in children <15 years old, including cases of GBS. Cases of GBS with available cerebrospinal fluid(CSF) and nerve conduction studies (NCS) results, neurological examination, clinical history, and exclusion of related diagnoses were selected (2002–2003). Relevant data were abstracted and entered into a central database. Sensitivity of the Brighton GBS criteria for level 3 of diagnostic certainty which requires no clinical laboratory testing, level 2 which employs CSF or NCS, and level 1 which employs both, were calculated. Results 79 cases of GBS (mean age 6.5 years, range 4.0–14.5; 39% female) met the case definition. GBS cases were ascending (79%), symmetrical (85%), and bilateral (100%); involving lower extremity hypotonia (86%) and weakness (100%), upper extremity hypotonia (62%) and weakness (80%), areflexia/hyporeflexia (88%), respiratory muscles (22%), bulbar muscles (22%), and cranial nerves (13%). Four limbs were involved in 80% of cases. Mean time to maximal weakness was 5.2 days (range 0.5–30 days) with nadir GBS disability scores of 3 (7%), 4 (67%), 5 (15%), 6 (10%), or unclear (1%). CSF (mean time to lumbar puncture 29 days) was normal in 29% with cytoalbuminologic dissociation in 65% (mean protein 105 mg/dL, range 10–1000; mean cell count 11/μL, range 0–220, n = 4 with >50 cells/μL). Significant improvement occurred in 73% whereas death (9%) occurred 6–29 days after sensorimotor symptom onset. The majority of cases (86%) fulfilled Brighton level 3, level 2 (84%), and level 1 (62%) of diagnostic certainty. Conclusion The

Evaluating Evidence Regarding Relationships with Criteria

ERIC Educational Resources Information Center

Balkin, Richard S.

2017-01-01

An overview of standards related to demonstrating evidence regarding relationships with criteria as it pertains to instrument development was presented, along with heuristic examples. Additional measures and a comprehensive design are necessary to establish evidence related to the use and interpretation of test scores for the validation of a…

Systemic Sclerosis Classification Criteria: Developing methods for multi-criteria decision analysis with 1000Minds

PubMed Central

Johnson, Sindhu R.; Naden, Raymond P.; Fransen, Jaap; van den Hoogen, Frank; Pope, Janet E.; Baron, Murray; Tyndall, Alan; Matucci-Cerinic, Marco; Denton, Christopher P.; Distler, Oliver; Gabrielli, Armando; van Laar, Jacob M.; Mayes, Maureen; Steen, Virginia; Seibold, James R.; Clements, Phillip; Medsger, Thomas A.; Carreira, Patricia E.; Riemekasten, Gabriela; Chung, Lorinda; Fessler, Barri J.; Merkel, Peter A.; Silver, Richard; Varga, John; Allanore, Yannick; Mueller-Ladner, Ulf; Vonk, Madelon C.; Walker, Ulrich A.; Cappelli, Susanna; Khanna, Dinesh

2014-01-01

Objective Classification criteria for systemic sclerosis (SSc) are being developed. The objectives were to: develop an instrument for collating case-data and evaluate its sensibility; use forced-choice methods to reduce and weight criteria; and explore agreement between experts on the probability that cases were classified as SSc. Study Design and Setting A standardized instrument was tested for sensibility. The instrument was applied to 20 cases covering a range of probabilities that each had SSc. Experts rank-ordered cases from highest to lowest probability; reduced and weighted the criteria using forced-choice methods; and re-ranked the cases. Consistency in rankings was evaluated using intraclass correlation coefficients (ICC). Results Experts endorsed clarity (83%), comprehensibility (100%), face and content validity (100%). Criteria were weighted (points): finger skin thickening (14–22), finger-tip lesions (9–21), friction rubs (21), finger flexion contractures (16), pulmonary fibrosis (14), SSc-related antibodies (15), Raynaud’s phenomenon (13), calcinosis (12), pulmonary hypertension (11), renal crisis (11), telangiectasia (10), abnormal nailfold capillaries (10), esophageal dilation (7) and puffy fingers (5). The ICC across experts was 0.73 (95%CI 0.58,0.86) and improved to 0.80 (95%CI 0.68,0.90). Conclusions Using a sensible instrument and forced-choice methods, the number of criteria were reduced by 39% (23 to 14) and weighted. Our methods reflect the rigors of measurement science, and serves as a template for developing classification criteria. PMID:24721558

Necessary constraints for an equation of state to be physically acceptable

NASA Astrophysics Data System (ADS)

Sheelendra, K.; Vijay, A.

2018-04-01

We have pointed out the constraints required for an equation of state (EOS) to be physically acceptable and universally applicable for the entire range of compressions for a material at high pressures. We have discussed the boundary conditions valid at zero pressure and infinite pressure. The concept of infinite pressure behavior has been discussed. It has been emphasized that the Stacey reciprocal K-primed EOS satisfies all the necessary criterion for the validity of EOS. On the other hand, equations of state reported previously do not satisfy the condition of physical acceptability of an equation of state.

14 CFR 170.23 - LORAN-C establishment criteria.

Code of Federal Regulations, 2011 CFR

2011-01-01

... ratio of the present value of the LORAN-C life-cycle benefits (PVB) to the present value of LORAN-C life-cycle costs (PVC): PVB/PVC ≥ 1.0 (c) The criteria do not cover all situations that may arise and are not... acceptable for instrument flight rules operations as a result of an airport airspace analysis conducted in...

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

PubMed Central

Angus, Derek C.; Seymour, Christopher W.; Coopersmith, Craig M.; Deutschman, Clifford; Klompas, Michael; Levy, Mitchell M.; Martin, Greg S.; Osborn, Tiffany M.; Rhee, Chanu; Watson, R. Scott

2016-01-01

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. PMID:26901559

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

PubMed

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.

Analysis of existing work-zone devices with MASH safety performance criteria.

DOT National Transportation Integrated Search

2009-02-01

Crashworthy, work-zone, portable sign support systems accepted under NCHRP Report No. 350 were analyzed to : predict their safety peformance according to the TL-3 MASH evaluation criteria. An analysis was conducted to determine : which hardware param...

Comparative Predictive Validity of the New MCAT Using Different Admissions Criteria.

ERIC Educational Resources Information Center

Golmon, Melton E.; Berry, Charles A.

1981-01-01

New Medical College Admission Test (MCAT) scores and undergraduate academic achievement were examined for their validity in predicting the performance of two select student populations at Northwestern University Medical School. The data support the hypothesis that New MCAT scores possess substantial predictive validity. (Author/MLW)

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

PubMed

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.

PubMed

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.

Evaluating the impacts of reducing the number of hot mix asphalt plant testing acceptance criteria on mix variability.

DOT National Transportation Integrated Search

2012-11-01

The acceptance testing of Hot Mix Asphalt (HMA) conducted at the HMA production facility is an : important portion of the overall acceptance process used by the Connecticut Department of : Transportation (ConnDOT) for paving projects. In 2004, ConnDO...

A proposed rationale and test methodology for establishment of acceptance criteria for vacuum integrity testing of pharmaceutical freeze dryers.

PubMed

Hardwick, Lisa M; Nail, Steven L; Jarman, James; Hasler, Kai; Hense, Thomas

2013-10-01

A scientific rationale is proposed for the establishment of acceptance criteria for leak rates in pharmaceutical freeze dryers. A method was developed to determine the quantity of air that could leak into any lyophilizer from the outside while still maintaining Class 100/Grade A microbial conditions. A lyophilizing product is assumed most vulnerable to microbial contamination during secondary drying, when mass transfer of water vapor from product to condenser is minimal. Using the void volume of the dryer, calculated from change in internal pressure when a known volume of air is introduced, and the potential maximum bioburden of the leaked air (based on measured values), calculations can determine the allowable leaked volume of air, the flow rate required to admit that volume in a given time frame, and the pressure rise that would result from the leak over a given testing period. For the dryers in this study, using worst-case air quality conditions, it was determined that a leak resulting in a pressure rise of 0.027 mbar over a 30 min period would allow the dryers to remain in secondary drying conditions for 62 h before the established action level of one colony forming unit for each cubic meter of air space would be reached. Copyright © 2013 Elsevier B.V. All rights reserved.

Parental Perceptions and Recommendations of Computing Majors: A Technology Acceptance Model Approach

ERIC Educational Resources Information Center

Powell, Loreen; Wimmer, Hayden

2017-01-01

Currently, there are more technology related jobs then there are graduates in supply. The need to understand user acceptance of computing degrees is the first step in increasing enrollment in computing fields. Additionally, valid measurement scales for predicting user acceptance of Information Technology degree programs are required. The majority…

Feasibility and Acceptability of a Text Message-Based Smoking Cessation Program for Young Adults in Lima, Peru: Pilot Study

PubMed Central

Zevallos, Karine; Samolski, M Reuven; Requena, David; Velarde, Chaska; Briceño, Patricia; Piazza, Marina; Ybarra, Michele L

2017-01-01

Background In Peru’s urban communities, tobacco smoking generally starts during adolescence and smoking prevalence is highest among young adults. Each year, many attempt to quit, but access to smoking cessation programs is limited. Evidence-based text messaging smoking cessation programs are an alternative that has been successfully implemented in high-income countries, but not yet in middle- and low-income countries with limited tobacco control policies. Objective The objective was to assess the feasibility and acceptability of an short message service (SMS) text message-based cognitive behavioral smoking cessation program for young adults in Lima, Peru. Methods Recruitment included using flyers and social media ads to direct young adults interested in quitting smoking to a website where interested participants completed a Google Drive survey. Inclusion criteria were being between ages 18 and 25 years, smoking at least four cigarettes per day at least 6 days per week, willing to quit in the next 30 days, owning a mobile phone, using SMS text messaging at least once in past year, and residing in Lima. Participants joined one of three phases: (1) focus groups and in-depth interviews whose feedback was used to develop the SMS text messages, (2) validating the SMS text messages, and (3) a pilot of the SMS text message-based smoking cessation program to test its feasibility and acceptability among young adults in Lima. The outcome measures included adherence to the SMS text message-based program, acceptability of content, and smoking abstinence self-report on days 2, 7, and 30 after quitting. Results Of 639 participants who completed initial online surveys, 42 met the inclusion criteria and 35 agreed to participate (focus groups and interviews: n=12; validate SMS text messages: n=8; program pilot: n=15). Common quit practices and beliefs emerged from participants in the focus groups and interviews informed the content, tone, and delivery schedule of the messages used

Improving Estimates of Acceptable Growiing Stock in Young Upland Oak Forests in the Missouri Ozarks

Treesearch

Daniel C. Dey; Paul S. Johnson; H.E. Garrett

1998-01-01

Estimates of regeneration or growing stock in young oak forests may be too high unless criteria are established that define explicitly acceptable growing stock. In young hardwood stands, crown class can be used to identify acceptable growing stock because it is related to the future growth and survival of reproduction. A method is presented for assigning crown class...

Research diagnostic criteria for temporomandibular disorders (RDC/TMD): development of image analysis criteria and examiner reliability for image analysis.

PubMed

Ahmad, Mansur; Hollender, Lars; Anderson, Quentin; Kartha, Krishnan; Ohrbach, Richard; Truelove, Edmond L; John, Mike T; Schiffman, Eric L

2009-06-01

As part of the Multisite Research Diagnostic Criteria For Temporomandibular Disorders (RDC/TMD) Validation Project, comprehensive temporomandibular joint diagnostic criteria were developed for image analysis using panoramic radiography, magnetic resonance imaging (MRI), and computerized tomography (CT). Interexaminer reliability was estimated using the kappa (kappa) statistic, and agreement between rater pairs was characterized by overall, positive, and negative percent agreement. Computerized tomography was the reference standard for assessing validity of other imaging modalities for detecting osteoarthritis (OA). For the radiologic diagnosis of OA, reliability of the 3 examiners was poor for panoramic radiography (kappa = 0.16), fair for MRI (kappa = 0.46), and close to the threshold for excellent for CT (kappa = 0.71). Using MRI, reliability was excellent for diagnosing disc displacements (DD) with reduction (kappa = 0.78) and for DD without reduction (kappa = 0.94) and good for effusion (kappa = 0.64). Overall percent agreement for pairwise ratings was >or=82% for all conditions. Positive percent agreement for diagnosing OA was 19% for panoramic radiography, 59% for MRI, and 84% for CT. Using MRI, positive percent agreement for diagnoses of any DD was 95% and of effusion was 81%. Negative percent agreement was >or=88% for all conditions. Compared with CT, panoramic radiography and MRI had poor and marginal sensitivity, respectively, but excellent specificity in detecting OA. Comprehensive image analysis criteria for the RDC/TMD Validation Project were developed, which can reliably be used for assessing OA using CT and for disc position and effusion using MRI.

45 CFR 1388.6 - Program criteria-services and supports.

Code of Federal Regulations, 2011 CFR

2011-10-01

... according to accepted practices of scientific evaluation; (iv) Research methods that are used to test hypotheses, validate procedures, and field test projects; and (v) Direct service and project practices and...

Development and validation of an HPLC method for tetracycline-related USP monographs.

PubMed

Hussien, Emad M

2014-09-01

A novel reversed-phase HPLC method was developed and validated for the assay of tetracycline hydrochloride and the limit of 4-epianhydrotetracycline hydrochloride impurity in tetracycline hydrochloride commercial bulk and pharmaceutical products. The method employed L1 (3 µm, 150 × 4.6 mm) columns, a mobile phase of 0.1% phosphoric acid and acetonitrile at a flow rate of 1.0 mL/min, and detection at 280 nm. The separation was performed in HPLC gradient mode. Forced degradation studies showed that tetracycline eluted as a spectrally pure peak and was well resolved from its degradation products. The fast degradation of tetracycline hydrochloride and 4-epianhydrotetracycline hydrochloride in solution was retarded by controlling the autosampler temperature at 4 °C and using 0.1% H3 PO4 as diluent. The robustness of the method was tested starting with the maximum variations allowed in the US Pharmacopeia (USP) general chapter Chromatography <621>. The method was linear over the range 80-120% of the assay concentration (0.1 mg/mL) for tetracycline hydrochloride and 50-150% of the acceptance criteria specified in the individual USP monographs for 4-epianhydrotetracycline hydrochloride. The limit of quantification for 4-epianhydrotetracycline hydrochloride was 0.1 µg/mL, 20 times lower than the acceptance criteria. The method was specific, precise, accurate and robust. Copyright © 2014 John Wiley & Sons, Ltd.

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

PubMed Central

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 <10 cm3. Overall, neurological and qualitative survivals (OS, NS, QS) of cases with >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

Non-Scientific Criteria for Belief Sustain Counter-Scientific Beliefs.

PubMed

Metz, S Emlen; Weisberg, Deena S; Weisberg, Michael

2018-02-01

Why is evolutionary theory controversial among members of the American public? We propose a novel explanation: allegiance to different criteria for belief. In one interview study, two online surveys, and one nationally representative phone poll, we found that evolutionists and creationists take different justifications for belief as legitimate. Those who accept evolution emphasize empirical evidence and scientific consensus. Creationists emphasize not only the Bible and religious authority, but also knowledge of the heart. These criteria for belief remain predictive of views about evolution even when taking into account other related factors like religion, political affiliation, and education. Each view is supported by its own internally specified criteria for what constitutes a justified belief. Changing minds may thus require changing epistemic norms. Copyright © 2018 Cognitive Science Society, Inc.

Learning Intentions and Success Criteria: Learners' and Teachers' Views

ERIC Educational Resources Information Center

Crichton, Hazel; McDaid, Ann

2016-01-01

It is generally accepted that Assessment for Learning (AfL) strategies are effective in teaching and learning. Approaches within this framework include the use of formative feedback, self and peer assessment and setting and discussion of learning intentions (LIs) and success criteria (SC). There has been a great deal of research into AfL…

The acceptability and validity of self-collected nasal swabs for detection of influenza virus infection among older adults in Thailand.

PubMed

Goyal, Sonal; Prasert, Kriengkrai; Praphasiri, Prabda; Chittaganpitch, Malinee; Waicharoen, Sunthareeya; Ditsungnoen, Darunee; Jaichuang, Siriluk; Lindblade, Kim A

2017-09-01

Self-collection of nasal swabs could improve the timeliness of influenza virus detection in older adults. Measure the acceptability, adequacy, timeliness, and validity of self-collected nasal swabs among adults >65 years in Thailand. Our evaluation consisted of two parts: a one-month study among randomly selected, community-dwelling older adults to simulate community-based surveillance for acute respiratory infections (ARI); and a clinic study of older adults with ARI to evaluate the sensitivity and specificity of self-collected nasal swabs for influenza virus infection compared with healthcare worker (HCW)-collected nasal and nasopharyngeal swabs. In the community study, 24% of participants experienced an ARI during the observation period. All (100%) participants with an ARI self-collected nasal swabs within 72 hours of symptom onset of which 92% were considered adequate samples. In the clinic study, 45% of patients with ARI presented within 72 hours of symptom onset. The sensitivity of self-collected nasal swabs for detection of influenza virus infection was 78% (95% CI 40-97) compared to nasopharyngeal and 88% (95% CI 47-100) compared to nasal swabs collected by HCWs. Specificity was 100% (95% CI 97-100) compared to both methods. Self-collection of nasal swabs was found acceptable by 99% of participants in both studies. Self-collection of nasal swabs was acceptable to older adults in Thailand who were able to take adequate samples. Self-collection of nasal swabs may improve the timeliness of sample collection but lower sensitivity will need to be considered. © 2017 The Authors. Influenza and Other Respiratory Viruses Published by John Wiley & Sons Ltd.

Assessing Non-Technical Site Suitability Criteria for Stormwater Capture, Treatment and Recharge

NASA Astrophysics Data System (ADS)

Eisenstein, W.

2016-12-01

This presentation will describe a new method for assessing non-technical site suitability criteria for the siting of stormwater capture, treatment and recharge (or stormwater CTR) facilities in Sonoma County, California, USA. "Non-technical site suitability criteria" include issues such as community acceptance, aesthetics, nuisances and hazards, and compatibility with neighboring land uses, and are distinguished from "technical criteria" such as hydrology and soil characteristics that are the traditional subject of suitability analyses. Non-technical criteria are rarely, if ever, considered in formal siting suitability studies conducted by agencies and municipalities, yet can be fatal to the prospects of a given project's construction if not identified and mitigated. The researchers developed a new method for identifying and spatially characterizing relevant non-technical criteria through interviews and questionnaires with community stakeholders, and introducing those criteria into a spatial multi-criteria decision analysis framework that assesses site suitabilty across a study watershed (the Upper Petaluma River watershed in Sonoma County).

Emotional and Spiritual Quotient Approach Improve Biology Education Students’ Acceptance of Evolution Theory

NASA Astrophysics Data System (ADS)

Darussyamsu, R.; Fadilah, M.; Putri, D. H.

2018-04-01

Emotional and spiritual aspect is one of main factors that influence students’ acceptance of a theory. This study aim to measure university students’ acceptance of evolution by learns evolution using emotional and spiritual quotient (ESQ) approach. This is a quasi-experimental research using one shot case study design with the subject 36 biology educational students at Biology Department, Faculty of Mathematics and Natural Science, Universitas Negeri Padang. Data collected using the MATE instrument by Rutledge and Warden (2000) after the students learn evolution for eight meetings since January until March 2017. The result showed that by learning evolution theory combine with ESQ aspects increase students acceptance from very low become moderate acceptance. It concluded that ESQ aspects can improve students’ acceptance of evolution. Any criteria depend on it are discussed.

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

PubMed

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.

The changing purpose of Prader-Willi syndrome clinical diagnostic criteria and proposed revised criteria.

PubMed

Gunay-Aygun, M; Schwartz, S; Heeger, S; O'Riordan, M A; Cassidy, S B

2001-11-01

Prader-Willi syndrome (PWS) is a complex, multisystem disorder. Its major clinical features include neonatal hypotonia, developmental delay, short stature, behavioral abnormalities, childhood-onset obesity, hypothalamic hypogonadism, and characteristic appearance. The genetic basis of PWS is also complex. It is caused by absence of expression of the paternally active genes in the PWS critical region on 15q11-q13. In approximately 70% of cases this is the result of deletion of this region from the paternal chromosome 15. In approximately 28%, it is attributable to maternal uniparental disomy (UPD; inheritance of 2 copies of a chromosome from the mother and no copies from the father, as opposed to the normal 1 copy from each parent) of chromosome 15, and in <2%, it is the result of a mutation, deletion, or other defect in the imprinting center. Clinical diagnostic criteria were established by consensus in 1993. Subsequently, definitive molecular genetic testing became available for laboratory diagnosis of PWS. However, identification of appropriate patients for testing remains a challenge for most practitioners because many features of the disorder are nonspecific and others can be subtle or evolve over time. For example, hypotonic infants who are still in the failure to thrive phase of the disorder often do not have sufficient features for recognition of PWS and often are not tested. Initial screening with these diagnostic criteria can increase the yield of molecular testing for older children and adults with nonspecific obesity and mental retardation. Therefore, the purpose of clinical diagnostic criteria has shifted from assisting in making the definitive diagnosis to raising diagnostic suspicion, thereby prompting testing. We conducted a retrospective review of patients with PWS confirmed with genetic testing to assess the validity and sensitivity of clinical diagnostic criteria published before the widespread availability of testing for all affected patients and

29 CFR 1607.5 - General standards for validity studies.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 29 Labor 4 2010-07-01 2010-07-01 false General standards for validity studies. 1607.5 Section 1607... studies. A. Acceptable types of validity studies. For the purposes of satisfying these guidelines, users may rely upon criterion-related validity studies, content validity studies or construct validity...

Development of code evaluation criteria for assessing predictive capability and performance

NASA Technical Reports Server (NTRS)

Lin, Shyi-Jang; Barson, S. L.; Sindir, M. M.; Prueger, G. H.

1993-01-01

Computational Fluid Dynamics (CFD), because of its unique ability to predict complex three-dimensional flows, is being applied with increasing frequency in the aerospace industry. Currently, no consistent code validation procedure is applied within the industry. Such a procedure is needed to increase confidence in CFD and reduce risk in the use of these codes as a design and analysis tool. This final contract report defines classifications for three levels of code validation, directly relating the use of CFD codes to the engineering design cycle. Evaluation criteria by which codes are measured and classified are recommended and discussed. Criteria for selecting experimental data against which CFD results can be compared are outlined. A four phase CFD code validation procedure is described in detail. Finally, the code validation procedure is demonstrated through application of the REACT CFD code to a series of cases culminating in a code to data comparison on the Space Shuttle Main Engine High Pressure Fuel Turbopump Impeller.

An Open Trial of Acceptance-based Separated Family Treatment (ASFT) for Adolescents with Anorexia Nervosa

PubMed Central

Timko, C. Alix; Zucker, Nancy L.; Herbert, James D.; Rodriguez, Daniel; Merwin, Rhonda M.

2016-01-01

Family based-treatments have the most empirical support in the treatment of adolescent anorexia nervosa; yet, a significant percentage of adolescents and their families do not respond to manualized family based treatment (FBT). The aim of this open trial was to conduct a preliminary evaluation of an innovative family-based approach to the treatment of anorexia: Acceptance-based Separated Family Treatment (ASFT). Treatment was grounded in Acceptance and Commitment Therapy (ACT), delivered in a separated format, and included an ACT-informed skills program. Adolescents (ages 12–18) with anorexia or sub-threshold anorexia and their families received 20 treatment sessions over 24 weeks. Outcome indices included eating disorder symptomatology reported by the parent and adolescent, percentage of expected body weight achieved, and changes in psychological acceptance/avoidance. Half of the adolescents (48.0%) met criteria for full remission at the end of treatment, 29.8% met criteria for partial remission, and 21.3% did not improve. Overall, adolescents had a significant reduction in eating disorder symptoms and reached expected body weight. Treatment resulted in changes in psychological acceptance in the expected direction for both parents and adolescents. This open trial provides preliminary evidence for the feasibility, acceptability, and efficacy of ASFT for adolescents with anorexia. Directions for future research are discussed. PMID:25898341

Defining Clinical Response Criteria and Early Response Criteria for Precision Oncology: Current State-of-the-Art and Future Perspectives.

PubMed

Subbiah, Vivek; Chuang, Hubert H; Gambhire, Dhiraj; Kairemo, Kalevi

2017-02-15

In this era of precision oncology, there has been an exponential growth in the armamentarium of genomically targeted therapies and immunotherapies. Evaluating early responses to precision therapy is essential for "go" versus "no go" decisions for these molecularly targeted drugs and agents that arm the immune system. Many different response assessment criteria exist for use in solid tumors and lymphomas. We reviewed the literature using the Medline/PubMed database for keywords "response assessment" and various known response assessment criteria published up to 2016. In this article we review the commonly used response assessment criteria. We present a decision tree to facilitate selection of appropriate criteria. We also suggest methods for standardization of various response assessment criteria. The relevant response assessment criteria were further studied for rational of development, key features, proposed use and acceptance by various entities. We also discuss early response evaluation and provide specific case studies of early response to targeted therapy. With high-throughput, advanced computing programs and digital data-mining it is now possible to acquire vast amount of high quality imaging data opening up a new field of "omics in radiology"-radiomics that complements genomics for personalized medicine. Radiomics is rapidly evolving and is still in the research arena. This cutting-edge technology is poised to move soon to the mainstream clinical arena. Novel agents with new mechanisms of action require advanced molecular imaging as imaging biomarkers. There is an urgent need for development of standardized early response assessment criteria for evaluation of response to precision therapy.

Postcraniometric sex and ancestry estimation in South Africa: a validation study.

PubMed

Liebenberg, Leandi; Krüger, Gabriele C; L'Abbé, Ericka N; Stull, Kyra E

2018-05-24

With the acceptance of the Daubert criteria as the standards for best practice in forensic anthropological research, more emphasis is being placed on the validation of published methods. Methods, both traditional and novel, need to be validated, adjusted, and refined for optimal performance within forensic anthropological analyses. Recently, a custom postcranial database of modern South Africans was created for use in Fordisc 3.1. Classification accuracies of up to 85% for ancestry estimation and 98% for sex estimation were achieved using a multivariate approach. To measure the external validity and report more realistic performance statistics, an independent sample was tested. The postcrania from 180 black, white, and colored South Africans were measured and classified using the custom postcranial database. A decrease in accuracy was observed for both ancestry estimation (79%) and sex estimation (95%) of the validation sample. When incorporating both sex and ancestry simultaneously, the method achieved 70% accuracy, and 79% accuracy when sex-specific ancestry analyses were run. Classification matrices revealed that postcrania were more likely to misclassify as a result of ancestry rather than sex. While both sex and ancestry influence the size of an individual, sex differences are more marked in the postcranial skeleton and are therefore easier to identify. The external validity of the postcranial database was verified and therefore shown to be a useful tool for forensic casework in South Africa. While the classification rates were slightly lower than the original method, this is expected when a method is generalized.

Field Validation of Statistically-Based Acceptance Plan for Bituminous Airport Pavements. Volume 4. Computer Simulation of Multiple Acceptance Criteria.

DTIC Science & Technology

1984-08-01

9332 .9394 .91406’ .9413 .9429 .9441 1.6 .9452 .9463 .9474 .9U84 .?495 . 9505 .95,5 .9525 .9535 .9545 I .7 .9554 .3564 .9573 .9582 .9591 .9599 .9603...NVAR 010) I, 9))o 000291 20 3()=)SQRT( COV(1,1)) 0(1)) 3110 0002 )2 DO 30 1 , NVAR 000013 iA10 __ (029 3 00 2𔃿 J =1 ,NVAR 00003421) )002(4 25 CO R R

UPDATE ON PEC ACTIVITIES INCLUDING NEW EVALUATION CRITERIA, THE APPLICATION COMPLETENESS CHECKLIST, AND STATUS OF THE WEBSITE DEVELOPMENT

EPA Science Inventory

US EPA's Pathogen Equivalency Committee (PEC) has updated the evaluation criteria it uses to make recommendations of equivalency (to processes acceptable under 40CFR503) on innovative or alternative sludge pathogen reduction processes. These criteria will be presented along with ...

Living life with my child’s pain: The Parent Pain Acceptance Questionnaire (PPAQ)

PubMed Central

Smith, Allison M.; Sieberg, Christine B.; Odell, Shannon; Randall, Edin; Simons, Laura E.

2014-01-01

Objective Parents’ emotional, cognitive, and behavioral responses are highly influential upon children’s pain and functional outcomes. One important response to pediatric pain is acceptance: the degree to which an individual participates in routine daily activities in the presence of pain and is willing to let pain be a part of their life without efforts to control or avoid it. However, no tool currently exists to assess parents’ own acceptance of their child’s pain. The aim of this study was to validate the Parent Pain Acceptance Questionnaire (PPAQ). Method The PPAQ was administered to 310 parents of youth with chronic pain in an outpatient pediatric headache program and a day hospital pain rehabilitation program. An exploratory factor analysis revealed two factors for the PPAQ: an 11-item Activity Engagement scale and a 4-item Acceptance of Pain-Related Thoughts & Feelings scale. Results The PPAQ total score and subscales demonstrated strong internal consistency. Greater parent pain acceptance was positively associated with child pain acceptance, and was negatively correlated with parent protective behaviors, parent minimizing behaviors, parent and child pain catastrophizing, and child fear of pain. Parent protective behaviors and child pain acceptance both served as mediators of the relationship between parent pain acceptance and child functional disability. Conclusions The PPAQ is a valid measure of parent pain acceptance and may provide valuable insights into parent responses to child pain and the ways in which parent acceptance influences child outcomes. Clinical implications and suggestions for future research are discussed. PMID:25119514

Pilot Validation Study of the European Association of Urology Robotic Training Curriculum.

PubMed

Volpe, Alessandro; Ahmed, Kamran; Dasgupta, Prokar; Ficarra, Vincenzo; Novara, Giacomo; van der Poel, Henk; Mottrie, Alexandre

2015-08-01

The development of structured and validated training curricula is one of the current priorities in robot-assisted urological surgery. To establish the feasibility, acceptability, face validity, and educational impact of a structured training curriculum for robot-assisted radical prostatectomy (RARP), and to assess improvements in performance and ability to perform RARP after completion of the curriculum. A 12-wk training curriculum was developed based on an expert panel discussion and used to train ten fellows from major European teaching institutions. The curriculum included: (1) e-learning, (2) 1 wk of structured simulation-based training (virtual reality synthetic, animal, and cadaveric platforms), and (3) supervised modular training for RARP. The feasibility, acceptability, face validity, and educational impact were assessed using quantitative surveys. Improvement in the technical skills of participants over the training period was evaluated using the inbuilt validated assessment metrics on the da Vinci surgical simulator (dVSS). A final RARP performed by fellows on completion of their training was assessed using the Global Evaluative Assessment of Robotic Skills (GEARS) score and generic and procedure-specific scoring criteria. The median baseline experience of participants as console surgeon was 4 mo (interquartile range [IQR] 0-6.5 mo). All participants completed the curriculum and were involved in a median of 18 RARPs (IQR 14-36) during modular training. The overall score for dVSS tasks significantly increased over the training period (p<0.001-0.005). At the end of the curriculum, eight fellows (80%) were deemed able by their mentors to perform a RARP independently, safely, and effectively. At assessment of the final RARP, the participants achieved an average score ≥4 (scale 1-5) for all domains using the GEARS scale and an average score >10 (scale 4-16) for all procedural steps using a generic dedicated scoring tool. In performance comparison using this

CFD validation experiments for hypersonic flows

NASA Technical Reports Server (NTRS)

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.

Criterion for evaluating the predictive ability of nonlinear regression models without cross-validation.

PubMed

Kaneko, Hiromasa; Funatsu, Kimito

2013-09-23

We propose predictive performance criteria for nonlinear regression models without cross-validation. The proposed criteria are the determination coefficient and the root-mean-square error for the midpoints between k-nearest-neighbor data points. These criteria can be used to evaluate predictive ability after the regression models are updated, whereas cross-validation cannot be performed in such a situation. The proposed method is effective and helpful in handling big data when cross-validation cannot be applied. By analyzing data from numerical simulations and quantitative structural relationships, we confirm that the proposed criteria enable the predictive ability of the nonlinear regression models to be appropriately quantified.

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

USGS Publications Warehouse

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: A Family-Centered Communication Skill.

PubMed

Harvey, Pat; Ahmann, Elizabeth

2016-01-01

Family-centered care can seem challenging when family member behavior, choices, attitudes, or emotions are "difficult" or "challenging" to deal with. Yet nurses can develop skills to effectively interact with families in a wide variety of circumstances and then become able to practice family-centered care in any situation that might arise. One particularly useful skill is "validation," which means accepting what the family member says or does as a valid expression of thoughts and feelings in that particular circumstance at that particular time. Validation does not mean there is agreement or acceptance of unsafe behaviors, only that the nurse acknowledges that the family member's concerns and feelings are important and should be listened to and taken seriously, even in the presence of disagreement. Validation, which should be individualized, can take many forms, ranging from providing complete attention to reflection of statements, identification of possible unexpressed emotions, normalization, and finally, a full and genuine sense of connection. Understanding and practicing validation can empower nurses and family members, as well as support effectivefamily-centered communication and problem solving even in challenging circumstances.

Validation: a family-centered communication skill.

PubMed

Harvey, Pat; Ahmann, Elizabeth

2014-01-01

Family-centered care can seem challenging when family member behavior, choices, attitudes, or emotions are "difficult" or "challenging" to deal with. Yet nurses can develop skills to effectively interact with families in a wide variety of circumstances and then become able to practice family-centered care in any situation that might arise. One particularly useful skill is "validation," which means accepting what the family member says or does as a valid expression of thoughts and feelings in that particular circumstance at that particular time. Validation does not mean there is agreement or acceptance of unsafe behaviors, only that the nurse acknowledges that the family member's concerns and feelings are important and should be listened to and taken seriously, even in the presence of disagreement. Validation, which should be individualized, can take many forms, ranging from providing complete attention to reflection of statements, identification of possible unexpressed emotions, normalization, and finally, a full and genuine sense of connection. Understanding and practicing validation can empower nurses and family members, as well as support effective family-centered communication and problem solving, even in challenging circumstances.

Bibliometrics for Social Validation.

PubMed

Hicks, Daniel J

2016-01-01

This paper introduces a bibliometric, citation network-based method for assessing the social validation of novel research, and applies this method to the development of high-throughput toxicology research at the US Environmental Protection Agency. Social validation refers to the acceptance of novel research methods by a relevant scientific community; it is formally independent of the technical validation of methods, and is frequently studied in history, philosophy, and social studies of science using qualitative methods. The quantitative methods introduced here find that high-throughput toxicology methods are spread throughout a large and well-connected research community, which suggests high social validation. Further assessment of social validation involving mixed qualitative and quantitative methods are discussed in the conclusion.

Bibliometrics for Social Validation

PubMed Central

2016-01-01

This paper introduces a bibliometric, citation network-based method for assessing the social validation of novel research, and applies this method to the development of high-throughput toxicology research at the US Environmental Protection Agency. Social validation refers to the acceptance of novel research methods by a relevant scientific community; it is formally independent of the technical validation of methods, and is frequently studied in history, philosophy, and social studies of science using qualitative methods. The quantitative methods introduced here find that high-throughput toxicology methods are spread throughout a large and well-connected research community, which suggests high social validation. Further assessment of social validation involving mixed qualitative and quantitative methods are discussed in the conclusion. PMID:28005974

User acceptance of mobile health services from users' perspectives: The role of self-efficacy and response-efficacy in technology acceptance.

PubMed

Zhang, Xiaofei; Han, Xiaocui; Dang, Yuanyuan; Meng, Fanbo; Guo, Xitong; Lin, Jiayue

2017-03-01

With the swift emergence of electronic medical information, the global popularity of mobile health (mHealth) services continues to increase steadily. This study aims to investigate the efficacy factors that directly or indirectly influence individuals' acceptance of mHealth services. Based on the technology acceptance model, this research incorporates efficacy factors into the acceptance decision process. A research model was proposed involving the direct and indirect effects of self-efficacy and response-efficacy on acceptance intention, along with their moderating effects. The model and hypotheses were validated using data collected from a field survey of 650 potential service users. The results reveal that: (1) self-efficacy and response-efficacy are both positively associated with perceived ease of use; and (2) self-efficacy and response-efficacy moderate the impact of perceived usefulness toward adoption intention. Self-efficacy and response-efficacy both play an important role in individuals' acceptance of mHealth services, which not only affect their perceived ease of use of mHealth services, but also positively moderate the effects of perceived usefulness on adoption intention. Our findings serve to provide recommendations that are specifically customized for mHealth service providers and their marketers.

[Validation of cold chain during distribution of parenteral nutrition].

PubMed

Tuan, Federico; Perone, Virginia; Verdini, Rocio; Pell, Maria Betina; Traverso, Maria Luz

2015-09-01

this study aims to demonstrate the suitability of the process used to condition the extemporaneous mixtures of parenteral nutrition for distribution, considering the objective of preserving the cold chain during transport until it reaches the patient, necessary to ensure stability, effectiveness and safety of these mixtures. concurrent validation, design and implementation of a protocol for evaluating the process of packaging and distribution of MNPE developed by a pharmaceutical laboratory. Running tests, according to predefined acceptance criteria. It is performed twice, in summer and on routes that require longer transfer time. Evaluation of conservation of temperature by monitoring the internal temperature values of each type of packaging, recorded by data loggers calibrated equipment. the different tests meet the established criteria. The collected data ensure the maintenance of the cold chain for longer than the transfer time to the most distant points. this study establishes the suitability of the processes to maintaining the cold chain for transfer from the laboratory to the patient pharmacist. Whereas the breaking of cold chain can cause changes of compatibility and stability of parenteral nutrition and failures nutritional support, this study contributes to patient safety, one of the relevant dimensions of quality of care the health. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.

Evaluating Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Posttraumatic Stress Disorder Diagnostic Criteria in Older Children and Adolescents

PubMed Central

Scheeringa, Michael S.; Weems, Carl F.

2017-01-01

Abstract Objectives: Few studies have assessed how the diagnostic criteria for posttraumatic stress disorder (PTSD) apply to older children and adolescents. With the introduction of a new, developmentally sensitive set of criteria for very young children (age 6 years and younger) in Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5), this raises new questions about the validity of the criteria for older children and adolescents. The current study investigated how diagnostic changes in DSM-5 impact diagnosis rates in 7–18-year olds. Methods: PTSD, impairment, and comorbid psychopathology were assessed in 135 trauma-exposed, treatment-seeking participants. Children (ages 7–12) were examined separately from adolescents (ages 13–18) to assess for potential developmental differences. Results: A significantly higher proportion of 7–12-year-old children met criteria for DSM-5 diagnosis (53%) compared to Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) (37%). However, among 13–18-year-old adolescents, the proportions diagnosed with DSM-5 (73%) and DSM-IV (74%) did not differ. Participants who met criteria for DSM-5 only (17%) did not differ from those diagnosed with DSM-IV in terms impairment or comorbidity. Using the newly accepted age 6 years and younger criteria resulted in a significantly higher proportion of 7–12-year-old (but not 13–18-year olds) children meeting criteria compared to DSM-IV or DSM-5. However, these children showed less impairment and comorbidity than those diagnosed with DSM-IV. Conclusion: These findings suggest that DSM-5 criteria may be more developmentally sensitive than DSM-IV criteria, and may lead to higher prevalence rates of PTSD for 7–12-year-old children, but not for adolescents. Using the very young children criteria for 7–12-year-old children may further increase prevalence, but capture children with less severe psychopathology. PMID:28170306

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

PubMed

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

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

PubMed

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 <2 cm) was low (range, 26%-34%). Use of the OPTN system would have resulted in different management in 17% of our population who had received automatic exception points for HCC 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.

Study on Influencing Factor Analysis and Application of Consumer Mobile Commerce Acceptance

NASA Astrophysics Data System (ADS)

Li, Gaoguang; Lv, Tingjie

Mobile commerce (MC) refers to e-commerce activities carried out using a mobile device such as a phone or PDA. With new technology, MC will be rapidly growing in the near future. At the present time, what factors making consumer accept MC and what MC applications are acceptable by consumers are two of hot issues both for MC providers and f or MC researchers. This study presents a proposed MC acceptance model that integrates perceived playfulness, perceived risk and cost into the TAM to study which factors affect consumer MC acceptance. The proposed model includes five variables, namely perceived risk, cost, perceived usefulness, perceived playfulness, perceived ease of use, perceived playfulness. Then, using analytic hierarchy process (AHP) to calculate weight of criteria involved in proposed model. Finally, the study utilizes fuzzy comprehensive evaluation method to evaluate MC applications accepted possibility, and then a MC application is empirically tested using data collected from a survey of MC consumers.

Hot mix asphalt voids acceptance review of QC/QA data 2000 through 2004.

DOT National Transportation Integrated Search

2006-07-01

This report analyzes the Quality Control/Quality Assurance (QC/QA) data for hot mix asphalt using voids acceptance as : the testing criteria for the years 2000 through 2004. Analysis of the overall quality of the HMA is accomplished by : reviewing th...

Hot mix asphalt voids acceptance review of QC/QA data 2000 through 2010.

DOT National Transportation Integrated Search

2011-10-01

This report analyzes the quality control/quality assurance (QC/QA) data for hot mix asphalt (HMA) using : voids acceptance as the testing criteria awarded in the years 2000 through 2010. Analysis of the overall : performance of the projects is accomp...

Compiler Acceptance Criteria Guidebook

DTIC Science & Technology

1977-05-01

further delineated in subseuent sub-charts. P.11 items in the sub-charts are discussed as to their relative merit...object modules) enafles cor’niler systers to rinirize their resource requirerents. Usually there is no major benefit in having the entire comnpiler core...system and for their reasonable specification to the vendina organization. The specification charts developed in Part 1 also provide a meaningful

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

ERIC Educational Resources Information Center

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…

Evaluation of clinical measurements and development of new diagnostic criteria for Takayasu arteritis in a Chinese population.

PubMed

Kong, X; Ma, L; Wu, L; Chen, H; Ma, L; Sun, Y; Wu, W; Ji, Z; Zhang, Z; Yang, C; Ye, S; Chen, S; Dai, S; Xue, Y; Qin, G; Zou, Y; Yu, Q; Jiang, L

2015-01-01

Takayasu arteritis (TA) is a chronic granulomatous large-vessel vasculitis. When diagnosing TA, the criteria designed by the American College of Rheumatology (ACR) are used commonly but they were just classification criteria. There is an urgent need for a new set of diagnostic criteria. One hundred and thirty-one TA patients and 132 control patients with other types of vascular disease were enrolled and both groups were distributed into a "training set" and a "validation set". All general information as well as clinical, laboratory and imaging data were collected. After comparing all the medical records of two groups in the training set, logistic regression and clinical judgment were used to form the new criteria for TA. The new criteria were tested by the validation set. New TA diagnostic criteria within total score 26 include age (<40 years), female, chest pain/chest distress, amaurosis, vascular bruits, a decreased/absent pulse, involvement of the aortic arch or its major branches, and involvement of the abdominal aorta or its branches. Patients with a score ≥ 8 were diagnosed as TA. The sensitivity and specificity of our new criteria were 91.92% and 93.94%, respectively, higher than those of the ACR criteria (75.76%, 85.86%) and the Ishikawa criteria (56.57%, 94.95%). The areas under the ROC curves of the new criteria and ACR criteria were 0.981 and 0.868, respectively (p<0.001). Sensitivity and specificity tested in the validation set were 90.63% and 96.97%, respectively. The new diagnostic criteria exhibited high sensitivity and specificity and have demonstrated to be feasible in the diagnosis of TA.

Validation of psychoanalytic theories: towards a conceptualization of references.