Validation and application of a stability-indicating HPLC method for the in vitro determination of gastric and intestinal stability of venlafaxine.

PubMed

Asafu-Adjaye, Ebenezer B; Faustino, Patrick J; Tawakkul, Mobin A; Anderson, Lawrence W; Yu, Lawrence X; Kwon, Hyojong; Volpe, Donna A

2007-04-11

Gastrointestinal stability of venlafaxine was evaluated in vitro in simulated gastric (SGF) and intestinal (SIF) fluids using a stability indicating HPLC method. The method was validated using a 5 microm Ascentis C18 column (150 mm x 4.6 mm) and mobile phase consisting of 30% acetonitrile in 20 mM potassium phosphate buffer (pH 6.5) delivered isocratically at a flow rate of 1 mL/min with UV detection at 228 nm. Venlafaxine in USP simulated gastric and intestinal fluids (0.4 mg/mL) was incubated at 37 degrees C in a shaking water bath. The gastric stability study samples were assayed at 0, 15, 30 and 60 min intervals while sampling for the intestinal stability study was at 0, 1, 2 and 3 h. System suitability determinations gave R.S.D.s of 0.68, 0.5 and 3.9% for retention factor (k'), peak area and tailing factor, respectively. The method was shown to be accurate, precise, specific, and linear over the analytical range. Intra- and inter-day precision was <5.3%. Forced degradation studies of drug substance in basic media at 70 degrees C as well as in H2O2 for 1 h and ultra-violet photostability studies at 255 and 365 nm for 24 h did not produce any detectable degradation products. Forced degradation studies of drug substance in acidic media at 70 degrees C for 1 h produced the dehydro-venlafaxine degradant. Venlafaxine was stable in SGF (pH approximately 1.2) for the 1-h incubation period and in SIF (pH 6.8) up to 3 h with <1.5% relative difference (RD) between the amount of drug added and that found for all time points. This stability experiment in simulated gastric and intestinal fluids suggests that drug loss in the gastrointestinal tract takes place by membrane permeation rather than a degradation process.

Determination of aliskiren in tablet dosage forms by a validated stability-indicating RP-LC method.

PubMed

Wrasse-Sangoi, M; Sangoi, M S; Oliveira, P R; Secretti, L T; Rolim, C M B

2011-02-01

A reversed-phase liquid chromatography (RP-LC) method is validated for the determination of aliskiren in tablet dosage form. The LC method is carried out on a Waters XBridge C(18) column (150 × 4.6 mm i.d.), maintained at 25°C. The mobile phase consisted of acetonitrile:water (95:5, v/v)/phosphoric acid (25 mM, pH 3.0) (40:60, v/v), run at a flow rate of 1.0 mL/min, with photodiode array detector set at 229 nm. The chromatographic separation is obtained with aliskiren retention time of 3.68 min, and it is linear in the range of 10-300 μg/mL (r = 0.9999). The limits of detection and quantitation are 2.38 and 7.93 μg/mL, respectively. The specificity and stability-indicating capability of the method are proven through degradation studies, which also showed that there is no interference of the formulation excipients, showing that peak is free from any coeluting peak. The method showed adequate precision, with a relative standard deviation (RSD) values lower than 0.92%. Good values of accuracy were also obtained, with a mean value of 99.55%. Experimental design is used during validation to calculate method robustness. The proposed method is applied for the analysis of the tablet dosage forms, contributing to improve the quality control and to assure the therapeutic efficacy.

Development and Validation of Stability Indicating Spectroscopic Method for Content Analysis of Ceftriaxone Sodium in Pharmaceuticals

PubMed Central

Ethiraj, Revathi; Thiruvengadam, Ethiraj; Sampath, Venkattapuram Saravanan; Vahid, Abdul; Raj, Jithin

2014-01-01

A simple, selective, and stability indicating spectroscopic method has been selected and validated for the assay of ceftriaxone sodium in the powder for injection dosage forms. Proposed method is based on the measurement of absorbance of ceftriaxone sodium in aqueous medium at 241 nm. The method obeys Beer's law in the range of 5–50 μg/mL with correlation coefficient of 0.9983. Apparent molar absorptivity and Sandell's sensitivity were found to be 2.046 × 103 L mol−1 cm−1 and 0.02732 μg/cm2/0.001 absorbance units. This study indicated that ceftriaxone sodium was degraded in acid medium and also underwent oxidative degradation. Percent relative standard deviation associated with all the validation parameters was less than 2, showing compliance with acceptance criteria of Q2 (R1), International Conference on Harmonization (2005) guidelines. Then the proposed method was successfully applied to the determination of ceftriaxone sodium in sterile preparation and results were comparable with reported methods. PMID:27355020

The validity and reliability of a dynamic neuromuscular stabilization-heel sliding test for core stability.

PubMed

Cha, Young Joo; Lee, Jae Jin; Kim, Do Hyun; You, Joshua Sung H

2017-10-23

Core stabilization plays an important role in the regulation of postural stability. To overcome shortcomings associated with pain and severe core instability during conventional core stabilization tests, we recently developed the dynamic neuromuscular stabilization-based heel sliding (DNS-HS) test. The purpose of this study was to establish the criterion validity and test-retest reliability of the novel DNS-HS test. Twenty young adults with core instability completed both the bilateral straight leg lowering test (BSLLT) and DNS-HS test for the criterion validity study and repeated the DNS-HS test for the test-retest reliability study. Criterion validity was determined by comparing hip joint angle data that were obtained from BSLLT and DNS-HS measures. The test-retest reliability was determined by comparing hip joint angle data. Criterion validity was (ICC2,3) = 0.700 (p< 0.05), suggesting a good relationship between the two core stability measures. Test-retest reliability was (ICC3,3) = 0.953 (p< 0.05), indicating excellent consistency between the repeated DNS-HS measurements. Criterion validity data demonstrated a good relationship between the gold standard BSLLT and DNS-HS core stability measures. Test-retest reliability data suggests that DNS-HS core stability was a reliable test for core stability. Clinically, the DNS-HS test is useful to objectively quantify core instability and allow early detection and evaluation.

Simultaneous determination of aliskiren and hydrochlorothiazide from their pharmaceutical preparations using a validated stability-indicating MEKC method.

PubMed

Sangoi, Maximiliano S; Wrasse-Sangoi, Micheli; Oliveira, Paulo R; Rolim, Clarice M B; Steppe, Martin

2011-08-01

A stability-indicating MEKC method was developed and validated for the simultaneous determination of aliskiren (ALI) and hydrochlorothiazide (HCTZ) in pharmaceutical formulations using ranitidine as an internal standard (IS). Optimal conditions for the separation of ALI, HCTZ and its major impurity chlorothiazide (CTZ), IS and degradation products were investigated. The method employed 47 mM Tris buffer and 47 mM anionic detergent SDS solution at pH 10.2 as the background electrolyte. MEKC method was performed on a fused-silica capillary (40 cm) at 28°C. Applied voltage was 26 kV (positive polarity) and photodiode array (PDA) detector was set at 217 nm. The method was validated in accordance with the ICH requirements. The method was linear over the concentration range of 5-100 and 60-1200 μg/mL for HCTZ and ALI, respectively (r(2) >0.9997). The stability-indicating capability of the method was established by enforced degradation studies combined with peak purity assessment using the PDA detection. Precision and accuracy evaluated by RSD were lower than 2%. The method proved to be robust by a fractional factorial design evaluation. The proposed MEKC method was successfully applied for the quantitative analysis of ALI and HCTZ both individually and in a combined dosage tablet formulation to support the quality control. Copyright © 2011 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Development of validated stability indicating assay method for simultaneous estimation of metformin hydrochloride and vildagliptin by RP-HPLC.

PubMed

Satheeshkumar, N; Pradeepkumar, M; Shanthikumar, S; Rao, V J

2014-03-01

A simple, precise and stability-indicating HPLC method was developed and validated for the simultaneous determination of metformin hydrochloride (MET) and vildagliptin (VLG) in pharmaceutical dosage forms. The method involves use of easily available inexpensive laboratory reagents. The separation was achieved on Grace Cyano column (250 mm×4.6 mm) 5 µm with isocratic flow. The mobile phase was pumped at a flow rate of 1.0 mL/min, consisted of 25 mM ammonium bicarbonate buffer and acetonitrile (65:35, v/v). The UV detection was carried out at 207 nm. A linear response was observed over the concentration range of 25-125 µg/mL for MET and 50-250 µg/mL for VLG respectively. Limit of detection and limit of quantification for MET were 0.36 µg/mL and 1.22 µg/mL, and for VLG were 0.75 µg/mL and 2.51 µg/mL respectively. The method was successfully validated in accordance to ICH guidelines acceptance criteria for specificity, linearity, accuracy, precision, robustness, and system suitability. Individual drugs (MET and VLG) were exposed to thermal, photolytic, hydrolytic and oxidative stress conditions. The resultant stressed samples were analyzed by the proposed method. The method gave high resolution among the degradation products and the analytes. The peak purity of analyte peak in the stressed samples was confirmed by photo diode array detector. The proposed method was successfully applied for the quantitative analysis of MET and VLG in tablet dosage form, which will help to improve quality control and contribute to stability studies of pharmaceutical tablets containing these drugs. © Georg Thieme Verlag KG Stuttgart · New York.

Development and validation of stability indicating HPLC methods for related substances and assay analyses of amoxicillin and potassium clavulanate mixtures.

PubMed

Bellur Atici, Esen; Yazar, Yücel; Ağtaş, Çağan; Ridvanoğlu, Nurten; Karlığa, Bekir

2017-03-20

Antibacterial combinations consisting of the semisynthetic antibiotic amoxicillin (amox) and the β-lactamase inhibitor potassium clavulanate (clav) are commonly used and several chromatographic methods were reported for their quantification in mixtures. In the present work, single HPLC method for related substances analyses of amoxicillin and potassium clavulanate mixtures was developed and validated according to international conference on harmonization (ICH) guidelines. Eighteen amoxicillin and six potassium clavulanate impurities were successfully separated from each other by using triple gradient elution using a Thermo Hypersil Zorbax BDS C18 (250 mm×4.6mm, 3μm) column with 50μL injection volumes at a wavelength of 215nm. Commercially unavailable impurities were formed by degradation of amoxicillin and potassium clavulanate, identified by LC-MS studies and used during analytical method development and validation studies. Also, process related amoxicillin impurity-P was synthesized and characterized by using nuclear magnetic resonance (NMR) and mass spectroscopy (MS) for the first time. As complementary of this work, an assay method for amoxicillin and potassium clavulanate mixtures was developed and validated; stress-testing and stability studies of amox/clav mixtures was carried out under specified conditions according to ICH and analyzed by using validated stability-indicating assay and related substances methods. Copyright © 2016 Elsevier B.V. All rights reserved.

Specification Reformulation During Specification Validation

NASA Technical Reports Server (NTRS)

Benner, Kevin M.

1992-01-01

The goal of the ARIES Simulation Component (ASC) is to uncover behavioral errors by 'running' a specification at the earliest possible points during the specification development process. The problems to be overcome are the obvious ones the specification may be large, incomplete, underconstrained, and/or uncompilable. This paper describes how specification reformulation is used to mitigate these problems. ASC begins by decomposing validation into specific validation questions. Next, the specification is reformulated to abstract out all those features unrelated to the identified validation question thus creating a new specialized specification. ASC relies on a precise statement of the validation question and a careful application of transformations so as to preserve the essential specification semantics in the resulting specialized specification. This technique is a win if the resulting specialized specification is small enough so the user my easily handle any remaining obstacles to execution. This paper will: (1) describe what a validation question is; (2) outline analysis techniques for identifying what concepts are and are not relevant to a validation question; and (3) identify and apply transformations which remove these less relevant concepts while preserving those which are relevant.

Development and validation of stability indicating method for the quantitative determination of venlafaxine hydrochloride in extended release formulation using high performance liquid chromatography

PubMed Central

Kaur, Jaspreet; Srinivasan, K. K.; Joseph, Alex; Gupta, Abhishek; Singh, Yogendra; Srinivas, Kona S.; Jain, Garima

2010-01-01

Objective: Venlafaxine,hydrochloride is a structurally novel phenethyl bicyclic antidepressant, and is usually categorized as a serotonin–norepinephrine reuptake inhibitor (SNRI) but it has been referred to as a serotonin–norepinephrine–dopamine reuptake inhibitor. It inhibits the reuptake of dopamine. Venlafaxine HCL is widely prescribed in the form of sustained release formulations. In the current article we are reporting the development and validation of a fast and simple stability indicating, isocratic high performance liquid chromatographic (HPLC) method for the determination of venlafaxine hydrochloride in sustained release formulations. Materials and Methods: The quantitative determination of venlafaxine hydrochloride was performed on a Kromasil C18 analytical column (250 × 4.6 mm i.d., 5 μm particle size) with 0.01 M phosphate buffer (pH 4.5): methanol (40: 60) as a mobile phase, at a flow rate of 1.0 ml/min. For HPLC methods, UV detection was made at 225 nm. Results: During method validation, parameters such as precision, linearity, accuracy, stability, limit of quantification and detection and specificity were evaluated, which remained within acceptable limits. Conclusions: The method has been successfully applied for the quantification and dissolution profiling of Venlafaxine HCL in sustained release formulation. The method presents a simple and reliable solution for the routine quantitative analysis of Venlafaxine HCL. PMID:21814426

Validation of a stability-indicating hydrophilic interaction liquid chromatographic method for the quantitative determination of vitamin k3 (menadione sodium bisulfite) in injectable solution formulation.

PubMed

Ghanem, Mashhour M; Abu-Lafi, Saleh A; Hallak, Hussein O

2013-01-01

A simple, specific, accurate, and stability-indicating method was developed and validated for the quantitative determination of menadione sodium bisulfite in the injectable solution formulation. The method is based on zwitterionic hydrophilic interaction liquid chromatography (ZIC-HILIC) coupled with a photodiode array detector. The desired separation was achieved on the ZIC-HILIC column (250 mm × 4.6 mm, 5 μm) at 25°C temperature. The optimized mobile phase consisted of an isocratic solvent mixture of 200mM ammonium acetate (NH4AC) solution and acetonitrile (ACN) (20:80; v/v) pH-adjusted to 5.7 by glacial acetic acid. The mobile phase was fixed at 0.5 ml/min and the analytes were monitored at 261 nm using a photodiode array detector. The effects of the chromatographic conditions on the peak retention, peak USP tailing factor, and column efficiency were systematically optimized. Forced degradation experiments were carried out by exposing menadione sodium bisulfite standard and the injectable solution formulation to thermal, photolytic, oxidative, and acid-base hydrolytic stress conditions. The degradation products were well-resolved from the main peak and the excipients, thus proving that the method is a reliable, stability-indicating tool. The method was validated as per ICH and USP guidelines (USP34/NF29) and found to be adequate for the routine quantitative estimation of menadione sodium bisulfite in commercially available menadione sodium bisulfite injectable solution dosage forms.

A validated stability-indicating LC method for the separation of enantiomer and potential impurities of Linezolid using polar organic mode.

PubMed

Satyanarayana Raju, T; Vishweshwari Kutty, O; Ganesh, V; Yadagiri Swamy, P

2012-08-01

Although a number of methods are available for evaluating Linezolid and its possible impurities, a common method for separation if its potential impurities, degradants and enantiomer in a single method with good efficiency remain unavailable. With the objective of developing an advanced method with shorter runtimes, a simple, precise, accurate stability-indicating LC method was developed for the determination of purity of Linezolid drug substance and drug products in bulk samples and pharmaceutical dosage forms in the presence of its impurities and degradation products. This method is capable of separating all the related substances of Linezolid along with the chiral impurity. This method can also be used for the estimation of assay of Linezolid in drug substance as well as in drug product. The method was developed using Chiralpak IA (250 mm×4.6 mm, 5 μm) column. A mixture of acetonitrile, ethanol, n-butyl amine and trifluoro acetic acid in 96:4:0.10:0.16 (v/v/v/v) ratio was used as a mobile phase. The eluted compounds were monitored at 254 nm. Linezolid was subjected to the stress conditions of oxidative, acid, base, hydrolytic, thermal and photolytic degradation. The degradation products were well resolved from main peak and its impurities, proving the stability-indicating power of the method. The developed method was validated as per International Conference on Harmonization (ICH) guidelines with respect to specificity, limit of detection, limit of quantification, precision, linearity, accuracy, robustness and system suitability.

Stability-indicating RP-HPLC method for the simultaneous determination of escitalopram oxalate and clonazepam.

PubMed

Kakde, Rajendra B; Satone, Dinesh D; Gadapayale, Kamalesh K; Kakde, Megha G

2013-07-01

The objective of the current study was to develop a validated, specific stability-indicating reversed-phase liquid chromatographic (LC) method for the quantitative determination of escitalopram oxalate and clonazepam and their related substances in bulk drugs and pharmaceutical dosage forms in the presence of degradation products. Forced degradation studies were performed on the pure drugs of escitalopram oxalate and clonazepam, as per the stress conditions prescribed by the International Conference on Harmonization (ICH) using acid, base, oxidation, thermal stress and photolytic degradation to show the stability-indicating power of the method. Significant degradation was observed during acid and alkaline hydrolysis and no degradation was observed in other stress conditions. The chromatographic method was optimized using the samples generated from forced degradation studies. Good resolution between the peaks corresponded to the active pharmaceutical ingredients, escitalopram oxalate and clonazepam, and degradation products from the analyte were achieved on an ODS Hypersil C18 column (250 × 4.6 mm) using a mobile phase consisting of a mixture of acetonitrile-50 mM phosphate buffer + 10 mM triethylamine (70:30, v/v). The detection was conducted at 268 nm. The limit of detection and the limit of quantitation for escitalopram oxalate and clonazepam were established. The stress test solutions were assayed against the qualified working standards of escitalopram oxalate and clonazepam, which indicated that the developed LC method was stability-indicating. Validation of the developed LC method was conducted as per ICH requirements. The developed LC method was found to be suitable to check the quality of bulk samples of escitalopram oxalate and clonazepam.

Validation of a Stability-Indicating Method for Methylseleno-l-Cysteine (l-SeMC)

PubMed Central

Canady, Kristin; Cobb, Johnathan; Deardorff, Peter; Larson, Jami; White, Jonathan M.; Boring, Dan

2016-01-01

Methylseleno-l-cysteine (l-SeMC) is a naturally occurring amino acid analogue used as a general dietary supplement and is being explored as a chemopreventive agent. As a known dietary supplement, l-SeMC is not regulated as a pharmaceutical and there is a paucity of analytical methods available. To address the lack of methodology, a stability-indicating method was developed and validated to evaluate l-SeMC as both the bulk drug and formulated drug product (400 µg Se/capsule). The analytical approach presented is a simple, nonderivatization method that utilizes HPLC with ultraviolet detection at 220 nm. A C18 column with a volatile ion-pair agent and methanol mobile phase was used for the separation. The method accuracy was 99–100% from 0.05 to 0.15 mg/mL l-SeMC for the bulk drug, and 98–99% from 0.075 to 0.15 mg/mL l-SeMC for the drug product. Method precision was <1% for the bulk drug and was 3% for the drug product. The LOQ was 0.1 µg/mL l-SeMC or 0.002 µg l-SeMC on column. PMID:26199341

Stability-Indicating HPLC Determination of Gemcitabine in Pharmaceutical Formulations

PubMed Central

Singh, Rahul; Shakya, Ashok K.; Naik, Rajashri; Shalan, Naeem

2015-01-01

A simple, sensitive, inexpensive, and rapid stability indicating high performance liquid chromatographic method has been developed for determination of gemcitabine in injectable dosage forms using theophylline as internal standard. Chromatographic separation was achieved on a Phenomenex Luna C-18 column (250 mm × 4.6 mm; 5μ) with a mobile phase consisting of 90% water and 10% acetonitrile (pH 7.00 ± 0.05). The signals of gemcitabine and theophylline were recorded at 275 nm. Calibration curves were linear in the concentration range of 0.5–50 μg/mL. The correlation coefficient was 0.999 or higher. The limit of detection and limit of quantitation were 0.1498 and 0.4541 μg/mL, respectively. The inter- and intraday precision were less than 2%. Accuracy of the method ranged from 100.2% to 100.4%. Stability studies indicate that the drug was stable to sunlight and UV light. The drug gives 6 different hydrolytic products under alkaline stress and 3 in acidic condition. Aqueous and oxidative stress conditions also degrade the drug. Degradation was higher in the alkaline condition compared to other stress conditions. The robustness of the methods was evaluated using design of experiments. Validation reveals that the proposed method is specific, accurate, precise, reliable, robust, reproducible, and suitable for the quantitative analysis. PMID:25838825

Development and validation of a stability-indicating RP-HPLC method for determination of atomoxetine hydrochloride in tablets.

PubMed

Patel, Sejal K; Patel, Natvarlal J

2010-01-01

This paper describes the development of a stability-indicating RP-HPLC method for the determination of atomoxetine hydrochloride (ATX) in the presence of its degradation products generated from forced decomposition studies. The drug substance was subjected to stress conditions of acid, base, oxidation, wet heat, dry heat, and photodegradation. In stability tests, the drug was susceptible to acid, base, oxidation, and dry and wet heat degradation. It was found to be stable under the photolytic conditions tested. The drug was successfully separated from the degradation products formed under stress conditions on a Phenomenex C18 column (250 x 4.6 mm id, 5 microm particle size) by using acetonitrile-methanol-0.032 M ammonium acetate (55 + 05 + 40, v/v/v) as the mobile phase at 1.0 mL/min and 40 degrees C. Photodiode array detection at 275 nm was used for quantitation after RP-HPLC over the concentration range of 0.5-5 microg/mL with a mean recovery of 100.8 +/- 0.4% for ATX. Statistical analysis demonstrated that the method is repeatable, specific, and accurate for the estimation of ATX. Because the method effectively separates the drug from its degradation products, it can be used as a stability-indicating method.

Development and validation of stability-indicating high performance liquid chromatography method to analyze gatifloxacin in bulk drug and pharmaceutical preparations.

PubMed

Aljuffali, Ibrahim A; Kalam, Mohd Abul; Sultana, Yasmin; Imran, Ahamad; Alshamsan, Aws

2015-01-01

Quantitative determination of gatifloxacin in tablets, solid lipid nanoparticles (SLNs) and eye-drops using a very simple and rapid chromatographic technique was validated and developed. Formulations were analyzed using a reverse phase SUPELCO® 516 C-18-DB, 50306-U, HPLC column (250 mm × 4.6 mm, 5 μm) and a mobile phase consisting of disodium hydrogen phosphate buffer:acetonitrile (75:25, v/v) and with orthophosphoric acid pH was adjusted to 3.3 The flow rate was 1.0 mL/min and analyte concentrations were measured using a UV-detector at 293 nm. The analyses were performed at room temperature (25 ± 2 °C). Gatifloxacin was separated in all the formulations within 2.767 min. There were linear calibration curves over a concentration range of 4.0-40 μg.mL(-1) and correlation coefficients of 0.9998 with an average recovery above 99.91%. Detection of analyte from different dosage forms at the same Rt indicates the specificity and stability of the developed method.

A Simple and Specific Stability- Indicating RP-HPLC Method for Routine Assay of Adefovir Dipivoxil in Bulk and Tablet Dosage Form.

PubMed

Darsazan, Bahar; Shafaati, Alireza; Mortazavi, Seyed Alireza; Zarghi, Afshin

2017-01-01

A simple and reliable stability-indicating RP-HPLC method was developed and validated for analysis of adefovir dipivoxil (ADV).The chromatographic separation was performed on a C 18 column using a mixture of acetonitrile-citrate buffer (10 mM at pH 5.2) 36:64 (%v/v) as mobile phase, at a flow rate of 1.5 mL/min. Detection was carried out at 260 nm and a sharp peak was obtained for ADV at a retention time of 5.8 ± 0.01 min. No interferences were observed from its stress degradation products. The method was validated according to the international guidelines. Linear regression analysis of data for the calibration plot showed a linear relationship between peak area and concentration over the range of 0.5-16 μg/mL; the regression coefficient was 0.9999and the linear regression equation was y = 24844x-2941.3. The detection (LOD) and quantification (LOQ) limits were 0.12 and 0.35 μg/mL, respectively. The results proved the method was fast (analysis time less than 7 min), precise, reproducible, and accurate for analysis of ADV over a wide range of concentration. The proposed specific method was used for routine quantification of ADV in pharmaceutical bulk and a tablet dosage form.

Validated stability-indicating HPLC method for the determination of pridinol mesylate. Kinetics study of its degradation in acid medium.

PubMed

Bianchini, Romina M; Castellano, Patricia M; Kaufman, Teodoro S

2008-12-01

The stability of pridinol mesylate (PRI) was investigated under different stress conditions, including hydrolytic, oxidative, photolytic and thermal, as recommended by the ICH guidelines. Relevant degradation was found to take place under acidic (0.1N HCl) and photolytic (visible and long-wavelength UV-light) conditions, both yielding the product resulting from water elimination (ELI), while submission to an oxidizing environment gave the N-oxidation derivative (NOX). The standards of these degradation products were synthesized and characterized by IR, (1)H and (13)C NMR spectroscopy. A simple, sensitive and specific HPLC method was developed for the quantification of PRI, ELI and NOX in bulk drug, and the conditions were optimized by means of a statistical design strategy. The separation employs a C(18) column and a 51:9:40 (v/v/v) mixture of MeOH, 2-propanol and potassium phosphate solution (50mM, pH 6.0), as mobile phase, delivered at 1.0 ml min(-1); the analytes were detected and quantified at 220 nm. The method was validated, demonstrating to be accurate and precise (repeatability and intermediate precision levels) within the corresponding linear ranges of PRI (0.1-1.5 mg ml(-1); r=0.9983, n=18) and both impurities (0.1-1.3% relative to PRI, r=0.9996 and 0.9995 for ELI and NOX, respectively, n=18). Robustness against small modifications of pH and percentage of the aqueous mobile phase was ascertained and the limits of quantification of the analytes were also determined (0.4 and 0.5 microg ml(-1); 0.04% and 0.05% relative to PRI for ELI and NOX, respectively). Peak purity indices (>0.9997), obtained with the aid of diode-array detection, and satisfactory resolution (R(s)>2.0) between PRI and its impurities established the specificity of the determination, all these results proving the stability-indicating capability of the method. The kinetics of the degradation of PRI in acid medium was also studied, determining that this is a first-order process with regards

Validation of a Stability-Indicating Method for Methylseleno-L-Cysteine (L-SeMC).

PubMed

Canady, Kristin; Cobb, Johnathan; Deardorff, Peter; Larson, Jami; White, Jonathan M; Boring, Dan

2016-01-01

Methylseleno-L-cysteine (L-SeMC) is a naturally occurring amino acid analogue used as a general dietary supplement and is being explored as a chemopreventive agent. As a known dietary supplement, L-SeMC is not regulated as a pharmaceutical and there is a paucity of analytical methods available. To address the lack of methodology, a stability-indicating method was developed and validated to evaluate L-SeMC as both the bulk drug and formulated drug product (400 µg Se/capsule). The analytical approach presented is a simple, nonderivatization method that utilizes HPLC with ultraviolet detection at 220 nm. A C18 column with a volatile ion-pair agent and methanol mobile phase was used for the separation. The method accuracy was 99-100% from 0.05 to 0.15 mg/mL L-SeMC for the bulk drug, and 98-99% from 0.075 to 0.15 mg/mL L-SeMC for the drug product. Method precision was <1% for the bulk drug and was 3% for the drug product. The LOQ was 0.1 µg/mL L-SeMC or 0.002 µg L-SeMC on column. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

ESI-MSn and LC-ESI-MS studies to characterize forced degradation products of bosentan and a validated stability-indicating LC-UV method.

PubMed

Bansal, Gulshan; Singh, Ranjit; Saini, Balraj; Bansal, Yogita

2013-01-01

The present study reports the characterization of forced degradation products of bosentan and a validated stability-indicating HPLC method for the stability testing of bosentan tablets. The forced degradation was carried out under the conditions of hydrolysis, oxidation, dry heat and photolysis. The drug was found unstable in acid, alkali and oxidative media whereas stable to the hydrolysis in water, to dry heat and to photolysis. In total, six degradation products were formed in all conditions which were resolved in a single run on a C-18 column with gradient elution using ammonium acetate buffer (pH 4.5, 5.0mM), methanol and acetonitrile. Structures of all the degradation products were characterized through +ESI-MS(n) and LC-ESI-MS spectral data of bosentan as well as LC-ESI-MS spectral data of the products. The products II-VI were characterized as 6-amino-[2,2']bipyrimidinyl-4,5-diol, 6-amino-5-(2-methoxyphenoxy)-[2,2']-bipyrimidinyl-4-ol, 2-[6-amino-5-(2-methoxyphenoxy)-[2,2']-bipyrimidinyl-4-yloxy]-ethanol, 4-tert-butyl-N-[6-(1-methoxyethoxy)-5-(2-methoxyphenoxy)-[2,2']-bipyrimidinyl-4-yl]-benzenesulfonamide and 4-tert-butyl-N-[6-hydroxy-5-(2-methoxyphenoxy)-[2,2']bipyrimidinyl-4-yl]-benzenesulfonamide, respectively. The peak of the product I was found to be due to two secondary degradation products which co-eluted and were characterized as β-hydroxyethyl p-tert-butylphenylsulfonate (Ia) and 2-[2-(2-hydroxyethoxy)-phenoxy]-ethanol (Ib). These products were formed due to hydrolysis of sulfonamide and alkylaryl ether and the diaryl ether linkages as well as dehydration of the primary alcohol group. The most probable degradation mechanisms were proposed. The HPLC method was found to be stability-indicating, linear (2-100 μg ml(-1)), accurate, precise, sensitive, specific, rugged and robust for quantitation of the drug. The method was applied to the stability testing of the commercially available bosentan tablets successfully. Copyright © 2012 Elsevier B.V. All

Validated stability-indicating densitometric thin-layer chromatography: application to stress degradation studies of minocycline.

PubMed

Jain, Nilu; Jain, Gaurav Kumar; Ahmad, Farhan Jalees; Khar, Roop Krishen

2007-09-19

A simple, stability-indicating high-performance thin-layer liquid chromatographic (HPTLC) method for analysis of minocycline was developed and validated. The densitometric analysis was carried out at 345 nm using methanol-acetonitrile-isopropyl alcohol-water (5:4:0.5:0.5, v/v/v/v) as mobile phase. The method employed TLC aluminium plates pre-coated with silica gel 60F-254 as the stationary phase. To achieve good result, plates were sprayed with a 10% (w/v) solution of disodium ethylene diaminetetraacetic acid (EDTA), the pH of which was adjusted to 9.0. Compact spots of minocycline were found at R(f) = 0.30+/-0.02. For proposed procedure, linearity (r = 0.9997), limit of detection (3.7 ng spot(-1)), recovery (99.23-100.16%), and precision (% R.S.D. < or = 0.364) was found to be satisfactory. The drug undergoes acidic and basic degradation, oxidation and photodegradation. All the peaks of degradation products were well resolved from the pure drug with significantly different R(f) values. The acidic and alkaline degradation kinetics of minocycline, evaluated using this method, is found to be of first order.

Stability Indicating HPLC Determination of Risperidone in Bulk Drug and Pharmaceutical Formulations

PubMed Central

Dedania, Zarna R.; Dedania, Ronak R.; Sheth, Navin R.; Patel, Jigar B.; Patel, Bhavna

2011-01-01

The objective of the current study was to develop a validated stability-indicating assay method (SIAM) for risperidone after subjecting it to forced decomposition under hydrolysis, oxidation, photolysis, and thermal stress conditions. The liquid chromatographic separation was achieved isocratically on a symmetry C18 column (5 μm size, 250 mm × 4.6 mm i.d.) using a mobile phase containing methanol: acetonitrile (80 : 20, v/v) at a flow rate of 1 mL/min and UV detection at 280 nm. Retention time of risperidone was found to be 3.35 ± 0.01. The method was linear over the concentration range of 10–60 μg/mL(r 2 = 0.998) with a limit of detection and quantitation of 1.79 and 5.44 μg/mL, respectively. The method has the requisite accuracy, specificity, sensitivity, and precision to assay risperidone in bulk form and pharmaceutical dosage forms. Degradation products resulting from the stress studies did not interfere with the detection of Risperidone, and the assay is thus stability indicating. PMID:22007220

Analytical Stability-Indicating Methods for Alogliptin in Tablets by LC-CAD and LC-UV.

PubMed

Bertol, Charise Dallazem; Friedrich, Maria Tereza; Carlos, Graciela; Froehlich, Pedro Eduardo

2017-03-01

Stability-indicating LC methods using a UV detector and a charged aerosol detector (CAD) simultaneously were validated for the assessment of alogliptin (ALG) in tablets. The analysis was performed on a C8 column (250 × 4.6 mm, 5 μm) at a flow of 0.8 mL/min, using acetonitrile-10 mM ammonium acetate buffer (pH 3.5; 90 + 10, v/v) as mobile phase and UV detection at 275 nm. Validation followed the International Conference on Harmonization guidelines. The method was linear over the range of 25-200 μg/mL. Normality of the residuals showed a normal distribution, no autocorrelation, and homoscedasticity. LODs were 6.25 and 2.65 µg/mL and LOQs were 20.85 and 8.84 µg/mL for the CAD and the UV detector, respectively. The methods were precise and accurate. Excipients and degradation products did not interfere in the methods in studies of specificity. None of the factors studied in the analysis of robustness had a significant effect on the quantification of the ALG by the Pareto chart. The results of the assay obtained with LC-CAD and LC-UV were similar. The methods could be considered interchangeable and stability-indicating, and can be applied as an appropriate QC tool for analysis of ALG in tablets.

Development and validation of stability indicating the RP-HPLC method for the estimation of related compounds of guaifenesin in pharmaceutical dosage forms.

PubMed

Reddy, Sunil Pingili; Babu, K Sudhakar; Kumar, Navneet; Sekhar, Y V V Sasi

2011-10-01

A stability-indicating gradient reverse phase liquid chromatographic (RP-LC) method was developed for the quantitative determination of related substances of guaifenesin in pharmaceutical formulations. The baseline separation for guaifenesin and all impurities was achieved by utilizing a Water Symmetry C18 (150 mm × 4.6 mm) 5 μm column particle size and a gradient elution method. The mobile phase A contains a mixture of 0.02 M KH2PO4 (pH 3.2) and methanol in the ratio of 90:10 v/v, while the mobile phase B contains 0.02 M KH2PO4 (pH 3.2) and methanol in the ratio of 10:90 v/v, respectively. The flow rate of the mobile phase was 0.8 ml/min with a column temperature of 25°C and detection wavelength at 273 nm. Guaifenesin was subjected to the stress conditions of oxidative, acid, base, hydrolytic, thermal, and photolytic degradation. The developed method was validated as per ICH guidelines with respect to specificity, linearity, limit of detection and quantification, accuracy, precision, and robustness.

A validated stability-indicating HPLC method for determination of varenicline in its bulk and tablets

PubMed Central

2011-01-01

A simple, sensitive and accurate stability-indicating HPLC method has been developed and validated for determination of varenicline (VRC) in its bulk form and pharmaceutical tablets. Chromatographic separation was achieved on a Zorbax Eclipse XDB-C8 column (150 mm × 4.6 mm i.d., particle size 5 μm, maintained at ambient temperature) by a mobile phase consisted of acetonitrile and 50 mM potassium dihydrogen phosphate buffer (10:90, v/v) with apparent pH of 3.5 ± 0.1 and a flow rate of 1.0 ml/min. The detection wavelength was set at 235 nm. VRC was subjected to different accelerated stress conditions. The degradation products, when any, were well resolved from the pure drug with significantly different retention time values. The method was linear (r = 0.9998) at a concentration range of 2 - 14 μg/ml. The limit of detection and limit of quantitation were 0.38 and 1.11 μg/ml, respectively. The intra- and inter-assay precisions were satisfactory; the relative standard deviations did not exceed 2%. The accuracy of the method was proved; the mean recovery of VRC was 100.10 ± 1.08%. The proposed method has high throughput as the analysis involved short run-time (~ 6 min). The method met the ICH/FDA regulatory requirements. The proposed method was successfully applied for the determination of VRC in bulk and tablets with acceptable accuracy and precisions; the label claim percentages were 99.65 ± 0.32%. The results demonstrated that the method would have a great value when applied in quality control and stability studies for VRC. PMID:21672253

Validity, reliability and Norwegian adaptation of the Stroke-Specific Quality of Life (SS-QOL) scale.

PubMed

Pedersen, Synne Garder; Heiberg, Guri Anita; Nielsen, Jørgen Feldbæk; Friborg, Oddgeir; Stabel, Henriette Holm; Anke, Audny; Arntzen, Cathrine

2018-01-01

There is a paucity of stroke-specific instruments to assess health-related quality of life in the Norwegian language. The objective was to examine the validity and reliability of a Norwegian version of the 12-domain Stroke-Specific Quality of Life scale. A total of 125 stroke survivors were prospectively recruited. Questionnaires were administered at 3 months; 36 test-retests were performed at 12 months post stroke. The translation was conducted according to guidelines. The internal consistency was assessed with Cronbach's alpha; convergent validity, with item-to-subscale correlations; and test-retest, with Spearman's correlations. Scaling validity was explored by calculating both floor and ceiling effects. A priori hypotheses regarding the associations between the Stroke-Specific Quality of Life domain scores and scores of established measures were tested. Standard error of measurement was assessed. The Norwegian version revealed no major changes in back translations. The internal consistency values of the domains were Cronbach's alpha = 0.79-0.93. Rates of missing items were small, and the item-to-subscale correlation coefficients supported convergent validity (0.48-0.87). The observed floor effects were generally small, whereas the ceiling effects had moderate or high values (16%-63%). Test-retest reliability indicated stability in most domains, with Spearman's rho = 0.67-0.94 (all p < 0.001), whereas the rho was 0.35 (p < 0.05) for the 'Vision' domain. Hypothesis testing supported the construct validity of the scale. Standard error of measurement values for each domain were generated to indicate the required magnitudes of detectable change. The Norwegian version of the Stroke-Specific Quality of Life scale is a reliable and valid instrument with good psychometric properties. It is suited for use in health research as well as in individual assessments of persons with stroke.

Development and validation of a stability-indicating RP-HPLC-FLD method for determination of 5-[(4-chlorophenoxy) methyl]-1, 3, 4-oxadiazole-2-thiol; A novel drug candidate.

PubMed

Shehzadi, Naureen; Hussain, Khalid; Islam, Muhammad; Bukhari, Nadeem Irfan; Asif, Noman; Khan, Muhammad Tanveer; Salman, Muhammad; Qamar, Shaista; Parveen, Sajida; Zahid, Fakhra; Shah, Arshad Ali; Bilal, Abida; Abbasi, Muhammad Athar; Siddiqui, Sabahat Zahra; Rehman, Azizur

2018-03-01

The present study describes the development and validation of a simple high performance liquid chromatographic method for the determination of a novel drug candidate, 5-[(4-chlorophenoxy) methyl]-1, 3, 4-oxadiazole-2-thiol. The stability-indicating capacity of the method was evaluated by subjecting the compound's solution to hydrolytic, oxidative, photolytic, transition metal- and thermal- stress. The chromatographic separation was achieved over a C18 column (Promosil, 5 µm, 4.60 × 250 mm), maintained at 25°C, using an isocratic mobile phase comprising a mixture of acetonitrile and acidified water of pH 2.67 (1:1, v/v), at a flow rate of 1.00 mL/min and detection using a fluorescent light detector (excitation at 250 nm and emission at 410 nm). The Beer's law was followed over the concentration range 2.50-50.00 μg/ml. The recovery (98.56-100.19%, SD <5%), intraday accuracy and precision (97.31-100.81%, RSD <5%), inter-day accuracy and precision (97.50-100.75%, RSD <5%) and intermediate accuracy and precision (98.10-99.91%, RSD <5%) indicated that the method was reliable, repeatable, reproducible and rugged. The resolution and selectivity factors of the compound's peak from the nearest resolving peak, particularly in case of dry heat and copper metal stress, were found to be greater than 2 and 1, respectively, which indicated specificity and selectivity. The compound was extensively decomposed in alkaline-hydrolytic, oxidative, metal- and dry heat- stress. However, the compound in acidic and neutral conditions was resistant to photolysis. The results of the present study indicate that the developed method is specific, selective, sensitive and suitable, hence, may be used for quality control, stability testing and preformulation studies.

Development and validation of a stability-indicating RP-HPLC method for assay of betamethasone and estimation of its related compounds.

PubMed

Fu, Qiang; Shou, Minshan; Chien, Dwight; Markovich, Robert; Rustum, Abu M

2010-02-05

Betamethasone (9alpha-fluoro-16beta-methylprednisolone) is one of the members of the corticosteriod family of active pharmaceutical ingredient (API), which is widely used as an anti-inflammatory agent and also as a starting material to manufacture various esters of betamethasone. A stability-indicating reverse-phase high performance liquid chromatography (RP-HPLC) method has been developed and validated which can separate and accurately quantitate low levels of 26 betamethasone related compounds. The stability-indicating capability of the method was demonstrated through adequate separation of all potential betamethasone related compounds from betamethasone and also from each other that are present in aged and stress degraded betamethasone stability samples. Chromatographic separation of betamethasone and its related compounds was achieved by using a gradient elution at a flow rate of 1.0mL/min on a ACE 3 C18 column (150mmx4.6mm, 3microm particle size, 100A pore size) at 40 degrees C. Mobile phase A of the gradient was 0.1% methanesulfonic acid in aqueous solution and mobile phase B was a mixture of tert-butanol and 1,4-dioxane (7:93, v/v). UV detection at 254nm was employed to monitor the analytes. For betamethasone 21-aldehyde, the QL and DL were 0.02% and 0.01% respectively. For betamethasone and the rest of the betamethasone related compounds, the QL and DL were 0.05% and 0.02%. The precision of betamethasone assay is 0.6% and the accuracy of betamethasone assay ranged from 98.1% to 99.9%.

Stability indicating validated HPLC method for quantification of levothyroxine with eight degradation peaks in the presence of excipients.

PubMed

Shah, R B; Bryant, A; Collier, J; Habib, M J; Khan, M A

2008-08-06

A simple, sensitive, accurate, and robust stability indicating analytical method is presented for identification, separation, and quantitation of l-thyroxine and eight degradation impurities with an internal standard. The method was used in the presence of commonly used formulation excipients such as butylated hydroxyanisole, povidone, crospovidone, croscarmellose sodium, mannitol, sucrose, acacia, lactose monohydrate, confectionary sugar, microcrystalline cellulose, sodium laurel sulfate, magnesium stearate, talc, and silicon dioxide. The two active thyroid hormones: 3,3',5,5'-tetra-iodo-l-thyronine (l-thyroxine-T4) and 3,3',5-tri-iodo-l-thyronine (T3) and degradation products including di-iodothyronine (T2), thyronine (T0), tyrosine (Tyr), di-iodotyrosine (DIT), mono-iodotyrosine (MIT), 3,3',5,5'-tetra-iodothyroacetic acid (T4AA) and 3,3',5-tri-iodothyroacetic acid (T3AA) were assayed by the current method. The separation of l-thyroxine and eight metabolites along with theophylline (internal standard) was achieved using a C18 column (25 degrees C) with a mobile phase of trifluoroacetic acid (0.1%, v/v, pH 3)-acetonitrile in gradient elution at 0.8 ml/min at 223 nm. The sample diluent was 0.01 M methanolic NaOH. Method was validated according to FDA, USP, and ICH guidelines for inter-day accuracy, precision, and robustness after checking performance with system suitability. Tyr (4.97 min), theophylline (9.09 min), MIT (9.55 min), DIT (11.37 min), T0 (11.63 min), T2 (14.47 min), T3 (16.29 min), T4 (17.60 min), T3AA (22.71 min), and T4AA (24.83 min) separated in a single chromatographic run. Linear relationship (r2>0.99) was observed between the peak area ratio and the concentrations for all of the compounds within the range of 2-20 microg/ml. The total time for analysis, equilibration and recovery was 40 min. The method was shown to separate well from commonly employed formulation excipients. Accuracy ranged from 95 to 105% for T4 and 90 to 110% for all other

Analytical Method Validation of High-Performance Liquid Chromatography and Stability-Indicating Study of Medroxyprogesterone Acetate Intravaginal Sponges

PubMed Central

Batrawi, Nidal; Wahdan, Shorouq; Abualhasan, Murad

2017-01-01

Medroxyprogesterone acetate is widely used in veterinary medicine as intravaginal dosage for the synchronization of breeding cycle in ewes and goats. The main goal of this study was to develop reverse-phase high-performance liquid chromatography method for the quantification of medroxyprogesterone acetate in veterinary vaginal sponges. A single high-performance liquid chromatography/UV isocratic run was used for the analytical assay of the active ingredient medroxyprogesterone. The chromatographic system consisted of a reverse-phase C18 column as the stationary phase and a mixture of 60% acetonitrile and 40% potassium dihydrogen phosphate buffer as the mobile phase; the pH was adjusted to 5.6. The method was validated according to the International Council for Harmonisation (ICH) guidelines. Forced degradation studies were also performed to evaluate the stability-indicating properties and specificity of the method. Medroxyprogesterone was eluted at 5.9 minutes. The linearity of the method was confirmed in the range of 0.0576 to 0.1134 mg/mL (R2 > 0.999). The limit of quantification was shown to be 3.9 µg/mL. Precision and accuracy ranges were found to be %RSD <0.2 and 98% to 102%, respectively. Medroxyprogesterone capacity factor value of 2.1, tailing factor value of 1.03, and resolution value of 3.9 were obtained in accordance with ICH guidelines. Based on the obtained results, a rapid, precise, accurate, sensitive, and cost-effective analysis procedure was proposed for quantitative determination of medroxyprogesterone in vaginal sponges. This analytical method is the only available method to analyse medroxyprogesterone in veterinary intravaginal dosage form. PMID:28469407

Development and validation of stability indicating the RP-HPLC method for the estimation of related compounds of guaifenesin in pharmaceutical dosage forms

PubMed Central

Reddy, Sunil Pingili; Babu, K. Sudhakar; Kumar, Navneet; Sekhar, Y. V. V. Sasi

2011-01-01

Aim and background: A stability-indicating gradient reverse phase liquid chromatographic (RP-LC) method was developed for the quantitative determination of related substances of guaifenesin in pharmaceutical formulations. Materials and methods: The baseline separation for guaifenesin and all impurities was achieved by utilizing a Water Symmetry C18 (150 mm × 4.6 mm) 5 μm column particle size and a gradient elution method. The mobile phase A contains a mixture of 0.02 M KH2PO4 (pH 3.2) and methanol in the ratio of 90:10 v/v, while the mobile phase B contains 0.02 M KH2PO4 (pH 3.2) and methanol in the ratio of 10:90 v/v, respectively. The flow rate of the mobile phase was 0.8 ml/min with a column temperature of 25°C and detection wavelength at 273 nm. Results: Guaifenesin was subjected to the stress conditions of oxidative, acid, base, hydrolytic, thermal, and photolytic degradation. Conclusion: The developed method was validated as per ICH guidelines with respect to specificity, linearity, limit of detection and quantification, accuracy, precision, and robustness. PMID:23781462

Development and Validation of a Stability-indicating Reversed-phase UPLC-UV Method for the Assay of Imidacloprid and Estimation of its Related Compounds.

PubMed

Tian, Jingzhi; Rustum, Abu

2018-02-01

Imidacloprid is used as an active pharmaceutical ingredient (API) in veterinary drugs to control fleas and ticks for dogs and cats. Here we are reporting for the first time a validated stability-indicating reversed-phase UPLC-UV method for the assay of imidacloprid and estimation of its related compounds. The stability-indicating capability of this method has been demonstrated by a forced degradation study. All related compounds including processing impurities, imidacloprid API and degradates from stressed samples were well separated from each other. Structures of major degradates from forced degradation study were elucidated through UPLC-MS/MS and key degradation pathways were proposed from the proposed chemical structures of major degradates. The UPLC-UV method is carried out using an HSS T3 column (C18, 2.1 × 30 mm, 1.8 μm particle size) maintained at 30°C with mobile phase A (0.05% v/v of phosphoric acid in water) and mobile phase B (methanol/acetonitrile 75/25 v/v). Analytes are separated by a gradient elution and detected at 270 nm. The UPLC method is green and fast with only 6.5 min run time and about 3.5 ml mobile phase consumption for each sample analysis. The UPLC-UV method was validated according to ICH guidelines. © The Author 2017. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Longitudinal Validation of General and Specific Structural Features of Personality Pathology

PubMed Central

Wright, Aidan G.C.; Hopwood, Christopher J.; Skodol, Andrew E.; Morey, Leslie C.

2016-01-01

Theorists have long argued that personality disorder (PD) is best understood in terms of general impairments shared across the disorders as well as more specific instantiations of pathology. A model based on this theoretical structure was proposed as part of the DSM-5 revision process. However, only recently has this structure been subjected to formal quantitative evaluation, with little in the way of validation efforts via external correlates or prospective longitudinal prediction. We used the Collaborative Longitudinal Study of Personality Disorders dataset to: (1) estimate structural models that parse general from specific variance in personality disorder features, (2) examine patterns of growth in general and specific features over the course of 10 years, and (3) establish concurrent and dynamic longitudinal associations in PD features and a host of external validators including basic personality traits and psychosocial functioning scales. We found that general PD exhibited much lower absolute stability and was most strongly related to broad markers of psychosocial functioning, concurrently and longitudinally, whereas specific features had much higher mean stability and exhibited more circumscribed associations with functioning. However, both general and specific factors showed recognizable associations with normative and pathological traits. These results can inform efforts to refine the conceptualization and diagnosis of personality pathology. PMID:27819472

Validity, reliability and Norwegian adaptation of the Stroke-Specific Quality of Life (SS-QOL) scale

PubMed Central

Pedersen, Synne Garder; Heiberg, Guri Anita; Nielsen, Jørgen Feldbæk; Friborg, Oddgeir; Stabel, Henriette Holm; Anke, Audny; Arntzen, Cathrine

2018-01-01

Background: There is a paucity of stroke-specific instruments to assess health-related quality of life in the Norwegian language. The objective was to examine the validity and reliability of a Norwegian version of the 12-domain Stroke-Specific Quality of Life scale. Methods: A total of 125 stroke survivors were prospectively recruited. Questionnaires were administered at 3 months; 36 test–retests were performed at 12 months post stroke. The translation was conducted according to guidelines. The internal consistency was assessed with Cronbach’s alpha; convergent validity, with item-to-subscale correlations; and test–retest, with Spearman’s correlations. Scaling validity was explored by calculating both floor and ceiling effects. A priori hypotheses regarding the associations between the Stroke-Specific Quality of Life domain scores and scores of established measures were tested. Standard error of measurement was assessed. Results: The Norwegian version revealed no major changes in back translations. The internal consistency values of the domains were Cronbach’s alpha = 0.79–0.93. Rates of missing items were small, and the item-to-subscale correlation coefficients supported convergent validity (0.48–0.87). The observed floor effects were generally small, whereas the ceiling effects had moderate or high values (16%–63%). Test–retest reliability indicated stability in most domains, with Spearman’s rho = 0.67–0.94 (all p < 0.001), whereas the rho was 0.35 (p < 0.05) for the ‘Vision’ domain. Hypothesis testing supported the construct validity of the scale. Standard error of measurement values for each domain were generated to indicate the required magnitudes of detectable change. Conclusions: The Norwegian version of the Stroke-Specific Quality of Life scale is a reliable and valid instrument with good psychometric properties. It is suited for use in health research as well as in individual assessments of persons with stroke

Smart stability-indicating spectrophotometric methods for determination of binary mixtures without prior separation.

PubMed

El-Bardicy, Mohammad G; Lotfy, Hayam M; El-Sayed, Mohammad A; El-Tarras, Mohammad F

2008-01-01

Ratio subtraction and isosbestic point methods are 2 innovating spectrophotometric methods used to determine vincamine in the presence of its acid degradation product and a mixture of cinnarizine (CN) and nicergoline (NIC). Linear correlations were obtained in the concentration range from 8-40 microg/mL for vincamine (I), 6-22 microg/mL for CN (II), and 6-36 microg/mL for NIC (III), with mean accuracies 99.72 +/- 0.917% for I, 99.91 +/- 0.703% for II, and 99.58 +/- 0.847 and 99.83 +/- 1.039% for III. The ratio subtraction method was utilized for the analysis of laboratory-prepared mixtures containing different ratios of vincamine and its degradation product, and it was valid in the presence of up to 80% degradation product. CN and NIC in synthetic mixtures were analyzed by the 2 proposed methods with the total content of the mixture determined at their respective isosbestic points of 270.2 and 235.8 nm, and the content of CN was determined by the ratio subtraction method. The proposed method was validated and found to be suitable as a stability-indicating assay method for vincamine in pharmaceutical formulations. The standard addition technique was applied to validate the results and to ensure the specificity of the proposed methods.

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.

Development and validation of a rapid stability indicating HPLC-method using monolithic stationary phase and two spectrophotometric methods for determination of antihistaminic acrivastine in capsules

NASA Astrophysics Data System (ADS)

Gouda, Ayman A.; Hashem, Hisham; Jira, Thomas

2014-09-01

Simple, rapid and accurate high performance liquid chromatographic (HPLC) and spectrophotometric methods are described for determination of antihistaminic acrivastine in capsules. The first method (method A) is based on accurate, sensitive and stability indicating chromatographic separation method. Chromolith® Performance RP-18e column, a relatively new packing material consisting of monolithic rods of highly porous silica, was used as stationary phase applying isocratic binary mobile phase of ACN and 25 mM NaH2PO4 pH 4.0 in the ratio of 22.5:77.5 at flow rate of 5.0 mL/min and 40 °C. A diode array detector was used at 254 nm for detection. The elution time of acrivastine was found to be 2.080 ± 0.032. The second and third methods (methods B and C) are based on the oxidation of acrivastine with excess N-bromosuccinimide (NBS) and determination of the unconsumed NBS with, metol-sulphanilic acid (λmax: 520 nm) or amaranth dye (λmax: 530 nm). The reacted oxidant corresponds to the drug content. Beer’s law is obeyed over the concentration range 1.563-50, 2.0-20 and 1.0-10 μg mL-1 for methods A, B and C, respectively. The limits of detection and quantitation were 0.40, 0.292 and 0.113 μg mL-1 and 0.782, 0.973 and 0.376 μg mL-1 for methods A, B and C, respectively. The HPLC method was validated for system suitability, linearity, precision, limits of detection and quantitation, specificity, stability and robustness. Stability tests were done through exposure of the analyte solution for four different stress conditions and the results indicate no interference of degradants with HPLC-method. The proposed methods was favorably applied for determination of acrivastine in capsules formulation. Statistical comparison of the obtained results from the analysis of the studied drug to those of the reported method using t- and F-tests showed no significant difference between them.

Development and validation of a stability-indicating high performance liquid chromatographic assay for benoxinate.

PubMed

Chorny, Michael; Levy, Daniel; Schumacher, Ilana; Lichaa, Chaim; Gruzman, Boris; Livshits, Oleg; Lomnicky, Yossi

2003-04-24

Benoxinate is a local anaesthetic used for ophthalmic applications. The aim of this study was to develop a rapid and simple stability-indicating method for the determination of benoxinate formulated for ophthalmic use, evaluate its long-term stability and identify its major degradation product. Benoxinate was eluted on a 10 microm Spherisorb phenyl column, 250 x 3.2 mm, with a mobile phase consisting of acetonitrile-buffer (pH 3.5) (35:65, v/v), pumped at 0.8 ml min(-1) flow rate. The buffer was composed of sodium dihydrogen phosphate (50 mM), sodium hydrogen sulfate (2.5 mM) and 1-heptanesulfonic acid sodium salt (5 mM). The analyte was quantified spectrophotometrically at 308 nm. The chromatograms of benoxinate formulations obtained by this method showed benoxinate (t = 4.5 min) well resolved from its degradation product (t = 2.3 min), which was separately identified by means of HPLC-MS as 4-amino-3-butoxybenzoic acid. The assay was demonstrated to have high accuracy, precision and linearity. The method was implemented in investigating the long-term stability of benoxinate 0.4% ophthalmic solutions. The method was found to be simple, quick and selective in determining benoxinate concentrations in fresh and aged preparations.

Stability-indicating UPLC method for determining related substances and degradants in dronedarone.

PubMed

Pydimarry, Surya Prakash Rao; Cholleti, Vijay Kumar; Vangala, Ranga Reddy

2014-08-01

A simple, sensitive and reproducible method was developed on ultra-performance liquid chromatography coupled with photodiode array detection for the quantitative determination of dronedarone hydrochloride (DRO) in drug substance and pharmaceutical dosage forms. The method is applicable for the quantification of related substances and assays of drug substances. Chromatographic separation was achieved on Acquity UPLC BEH C8 100 mm, 2.1 mm and 1.7 µm columns, using gradient elution within a short run time of 10.0 min. The eluted compounds were monitored at 288 nm, the flow rate was 0.5 mL/min and the column oven temperature was maintained at 40°C. The resolution of DRO and 11 impurities (potentials and by-products) was greater than 2.0 for all pairs of components. The high correlation coefficient value (>0.9995) indicates the clear correlations between the concentrations of investigated compound and their peak areas within the test ranges. The repeatability and intermediate precision, expressed by the relative standard deviation, were less than 2.5%. The accuracy and validity of the method were further ascertained by performing recovery studies via a spike method. The accuracy of the method, expressed as relative error, was satisfactory. No interference was observed from concomitant substances normally added to the tablets. DRO was subjected to the stress conditions of oxidative, acid, base, hydrolytic, thermal and photolytic degradation. DRO was found to degrade significantly in acid and base stress conditions and to remain stable in thermal, photolytic degradation, oxidative and hydrolytic conditions. The degradation products were well resolved from primary peak and its impurities, proving that the method is stability indicating. The developed method was validated as per International Conference on Harmonization guidelines with respect to specificity, limit of detection, limit of quantification, linearity, accuracy, precision, solution stability and robustness

Reaction time as an indicator of insufficient effort: Development and validation of an embedded performance validity parameter.

PubMed

Stevens, Andreas; Bahlo, Simone; Licha, Christina; Liske, Benjamin; Vossler-Thies, Elisabeth

2016-11-30

Subnormal performance in attention tasks may result from various sources including lack of effort. In this report, the derivation and validation of a performance validity parameter for reaction time is described, using a set of malingering-indices ("Slick-criteria"), and 3 independent samples of participants (total n =893). The Slick-criteria yield an estimate of the probability of malingering based on the presence of an external incentive, evidence from neuropsychological testing, from self-report and clinical data. In study (1) a validity parameter is derived using reaction time data of a sample, composed of inpatients with recent severe brain lesions not involved in litigation and of litigants with and without brain lesion. In study (2) the validity parameter is tested in an independent sample of litigants. In study (3) the parameter is applied to an independent sample comprising cooperative and non-cooperative testees. Logistic regression analysis led to a derived validity parameter based on median reaction time and standard deviation. It performed satisfactorily in studies (2) and (3) (study 2 sensitivity=0.94, specificity=1.00; study 3 sensitivity=0.79, specificity=0.87). The findings suggest that median reaction time and standard deviation may be used as indicators of negative response bias. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Development and Validation of a Stability-Indicating RP-HPLC Method for Duloxetine Hydrochloride in its Bulk and Tablet Dosage Form

PubMed Central

Chhalotiya, Usmangani K.; Bhatt, Kashyap K.; Shah, Dimal A.; Baldania, Sunil L.

2010-01-01

The objective of the present work was to develop a stability-indicating RP-HPLC method for duloxetine hydrochloride (DUL) in the presence of its degradation products generated from forced decomposition studies. The drug substance was found to be susceptible to stress conditions of acid hydrolysis. The drug was found to be stable to dry heat, photodegradation, oxidation and basic condition attempted. Successful separation of the drug from the degradation products formed under acidic stress conditions was achieved on a Hypersil C-18 column (250 mm × 4.6 mm id, 5μm particle size) using acetonitrile: 0.01 M potassium dihydrogen phosphate buffer (pH 5.4 adjusted with orthophosphoric acid) (50:50, v/v) as the mobile phase at a flow rate of 1.0 ml/min. Quantification was achieved with photodiode array detection at 229 nm over the concentration range 1–25 μg/ml with range of recovery 99.8–101.3 % for DUL by the RP-HPLC method. Statistical analysis proved the method to be repeatable, specific, and accurate for estimation of DUL. It can be used as a stability-indicating method due to its effective separation of the drug from its degradation products, PMID:21179321

Stability indicating high performance thin-layer chromatographic method for simultaneous estimation of pantoprazole sodium and itopride hydrochloride in combined dosage form

PubMed Central

Bageshwar, Deepak; Khanvilkar, Vineeta; Kadam, Vilasrao

2011-01-01

A specific, precise and stability indicating high-performance thin-layer chromatographic method for simultaneous estimation of pantoprazole sodium and itopride hydrochloride in pharmaceutical formulations was developed and validated. The method employed TLC aluminium plates precoated with silica gel 60F254 as the stationary phase. The solvent system consisted of methanol:water:ammonium acetate; 4.0:1.0:0.5 (v/v/v). This system was found to give compact and dense spots for both itopride hydrochloride (Rf value of 0.55±0.02) and pantoprazole sodium (Rf value of 0.85±0.04). Densitometric analysis of both drugs was carried out in the reflectance–absorbance mode at 289 nm. The linear regression analysis data for the calibration plots showed a good linear relationship with R2=0.9988±0.0012 in the concentration range of 100–400 ng for pantoprazole sodium. Also, the linear regression analysis data for the calibration plots showed a good linear relationship with R2=0.9990±0.0008 in the concentration range of 200–1200 ng for itopride hydrochloride. The method was validated for specificity, precision, robustness and recovery. Statistical analysis proves that the method is repeatable and selective for the estimation of both the said drugs. As the method could effectively separate the drug from its degradation products, it can be employed as a stability indicating method. PMID:29403710

Stability indicating high performance thin-layer chromatographic method for simultaneous estimation of pantoprazole sodium and itopride hydrochloride in combined dosage form.

PubMed

Bageshwar, Deepak; Khanvilkar, Vineeta; Kadam, Vilasrao

2011-11-01

A specific, precise and stability indicating high-performance thin-layer chromatographic method for simultaneous estimation of pantoprazole sodium and itopride hydrochloride in pharmaceutical formulations was developed and validated. The method employed TLC aluminium plates precoated with silica gel 60F 254 as the stationary phase. The solvent system consisted of methanol:water:ammonium acetate; 4.0:1.0:0.5 (v/v/v). This system was found to give compact and dense spots for both itopride hydrochloride ( R f value of 0.55±0.02) and pantoprazole sodium ( R f value of 0.85±0.04). Densitometric analysis of both drugs was carried out in the reflectance-absorbance mode at 289 nm. The linear regression analysis data for the calibration plots showed a good linear relationship with R 2 =0.9988±0.0012 in the concentration range of 100-400 ng for pantoprazole sodium. Also, the linear regression analysis data for the calibration plots showed a good linear relationship with R 2 =0.9990±0.0008 in the concentration range of 200-1200 ng for itopride hydrochloride. The method was validated for specificity, precision, robustness and recovery. Statistical analysis proves that the method is repeatable and selective for the estimation of both the said drugs. As the method could effectively separate the drug from its degradation products, it can be employed as a stability indicating method.

Stability indicating RP-HPLC method development and validation for the simultaneous determination of aminexil and minoxidil in pharmaceutical dosage form.

PubMed

Siddiraju, S; Sahithi, M

2015-03-01

The objective of the present work is to develop stability indicating high-performance liquid chromatographic method for the simultaneous determination of aminexil and minoxidil in pharmaceutical dosage form. The chromatographic separation was achieved with BDS Hypersil C18 column (250 mm×4.6 mm×5 μ) as stationary phase and phosphate buffer and acetonitrile (78:22) as mobile phase. The method was employed by using a flow rate of 1.1 mL/min kept at 30°C. The detection wavelength was kept at 238 nm by using photo-diode array detector. The retention times of the aminexil and minoxidil were found to be 2.3 min and 3.9 min, respectively. The method developed was validated in accordance with ICH guidelines with respect to the stability indicating capacity of the method including system suitability, accuracy, precision, linearity, range, limit of detection, limit of quantification and robustness. The linearity responses of aminexil and minoxidil were found to be in the concentration ranges of 18.75-112.5 μg/mL and 25-150 μg/mL, respectively. The LOD and LOQ values for aminexil were found to be 0.31 and 0.92 μg/mL and minoxidil were found to be 0.03 and 0.10 μg/mL respectively. The percentage recoveries for both the drugs were found in the range of 98-101%. This method is accurate, precise and sensitive; hence, it can be employed for routine quality control of aminexil and minoxidil in pharmaceutical industries and drug testing laboratories. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

Development and validation of a novel stability-indicating HPLC method for the simultaneous assay of betamethasone-17-valerate, fusidic acid, potassium sorbate, methylparaben and propylparaben in a topical cream preparation.

PubMed

Byrne, Jonathan; Velasco-Torrijos, Trinidad; Reinhardt, Robert

2014-08-05

A novel stability-indicating reversed phase high performance liquid chromatographic (RP-HPLC) method for the simultaneous assay of betamethasone-17-valerate, fusidic acid and potassium sorbate as well as methyl- and propylparaben in a topical cream preparation has been developed. A 100mm×3.0mm ID. Ascentis Express C18 column maintained at 30°C and UV detection at 240nm were used. A gradient programme was employed at a flow-rate of 0.75ml/min. Mobile phase A comprised of an 83:17 (v/v) mixture of acetonitrile and methanol and mobile phase B of a 10g/l solution of 85% phosphoric acid in purified water. The method has been validated according to current International Conference on Harmonisation (ICH) guidelines and applied during formulation development and stability studies. The procedure has been shown to be stability-indicating for the topical cream. Copyright © 2014 Elsevier B.V. All rights reserved.

Test Score Stability and Construct Validity of the Adult Manifest Anxiety Scale-College Version Scores among College Students: A Brief Report

ERIC Educational Resources Information Center

Lowe, Patricia A.; Papanastasiou, Elena C.; DeRuyck, Kimberly A.; Reynolds, Cecil R.

2005-01-01

In this study, the authors investigated the temporal stability and construct validity of the Adult Manifest Anxiety Scale-College Version (AMAS-C; C. R. Reynolds, B. O. Richmond, & P. A. Lowe, 2003b) scores. Results indicated that the AMAS-C scores had adequate to excellent test score stability, and evidence supported the construct validity of the…

Reliability and validity of the closed kinetic chain upper extremity stability test.

PubMed

Lee, Dong-Rour; Kim, Laurentius Jongsoon

2015-04-01

[Purpose] The purpose of this study was to examine the reliability and validity of the Closed Kinetic Chain Upper Extremity Stability (CKCUES) test. [Subjects and Methods] A sample of 40 subjects (20 males, 20 females) with and without pain in the upper limbs was recruited. The subjects were tested twice, three days apart to assess the reliability of the CKCUES test. The CKCUES test was performed four times, and the average was calculated using the data of the last 3 tests. In order to test the validity of the CKCUES test, peak torque of internal/external shoulder rotation was measured using an isokinetic dynamometer, and maximum grip strength was measured using a hand dynamometer, and their Pearson correlation coefficients with the average values of the CKCUES test were calculated. [Results] The reliability of the CKCUES test was very high (ICC=0.97). The correlations between the CKCUES test and maximum grip strength (r=0.78-0.79), and the peak torque of internal/external shoulder rotation (r=0.87-0.94) were high indicating its validity. [Conclusion] The reliability and validity of the CKCUES test were high. The CKCUES test is expected to be used for clinical tests on upper limb stability at low price.

Stability-indicating RP-HPLC Method for the Simultaneous Determination of Sitagliptin and Simvastatin in Tablets

PubMed Central

Ramalingam, P.; Bhaskar, V. Udaya; Reddy, Y. Padmanabha; Kumar, K. Vinod

2014-01-01

A new stability-indicating high-performance liquid chromatographic method for simultaneous analysis of sitagliptin and simvastatin in pharmaceutical dosage form was developed and validated. The mobile phase consisted of methanol and water (70:30, v/v) with 0.2 % of n-heptane sulfonic acid adjusted to pH 3.0 with ortho phosphoric acid was used. Retentions of sitagliptin and simvastatin were 4.3 min and 30.4 min, respectively with a flow rate of 1 ml/min on C8 (Qualisil BDS, 250×4.6 mm, 5 μ). Eluents were detected at 253 nm using photodiode diode array detector. The linear regression analysis data for the linearity plot showed correlation coefficient values of 0.9998 and 0.9993 for sitagliptin and simvastatin, with respective concentration ranges of 20-150 μg/ml and 8-60 μg/ml. The relative standard deviation for inter-day precision was lower than 2.0%. The assay of sitagliptin and simvastatin was determined in tablet dosage form was found to be within limits. Both drugs were subjected to a variety of stress conditions such as acidic, basic, oxidation, photolytic, neutral and thermal stress in order to achieve adequate degradation. Results revealed that considerable degradation was found in all stress conditions except oxidative degradations. The method has proven specificity for stability indicating assay method. PMID:25425754

UPLC and LC-MS studies on degradation behavior of irinotecan hydrochloride and development of a validated stability-indicating ultra-performance liquid chromatographic method for determination of irinotecan hydrochloride and its impurities in pharmaceutical dosage forms.

PubMed

Kumar, Navneet; Sangeetha, Dhanaraj; Reddy, Sunil P

2012-10-01

The objective of the current investigation was to study the degradation behavior of irinotecan hydrochloride under different International Conference on Harmonization (ICH) recommended stress conditions using ultra-performance liquid chromatography and liquid chromatography-mass spectrometry and to establish a validated stability-indicating reverse-phase ultra-performance liquid chromatographic method for the quantitative determination of irinotecan hydrochloride and its seven impurities and degradation products in pharmaceutical dosage forms. Irinotecan hydrochloride was subjected to the stress conditions of oxidative, acid, base, hydrolytic, thermal and photolytic degradation. Irinotecan hydrochloride was found to degrade significantly in oxidative and base hydrolysis and photolytic degradation conditions. The degradation products were well resolved from the main peak and its impurities, thus proving the stability-indicating power of the method. Chromatographic separation was achieved on a Waters Acquity BEH C8 (100 × 2.1 mm) 1.7-µm column with a mobile phase containing a gradient mixture of solvent A (0.02M KH(2)PO(4) buffer, pH 3.4) and solvent B (a mixture of acetonitrile and methanol in the ratio of 62:38 v/v). The mobile phase was delivered at a flow rate of 0.3 mL/min with ultraviolet detection at 220 nm. The run time was 8 min, within which irinotecan and its seven impurities and degradation products were satisfactorily separated. The developed method was validated as per ICH guidelines with respect to specificity, linearity, limit of detection, limit of quantification, accuracy, precision and robustness. This method was also suitable for the assay determination of irinotecan hydrochloride in pharmaceutical dosage forms.

QbD-Based Development and Validation of a Stability-Indicating HPLC Method for Estimating Ketoprofen in Bulk Drug and Proniosomal Vesicular System.

PubMed

Yadav, Nand K; Raghuvanshi, Ashish; Sharma, Gajanand; Beg, Sarwar; Katare, Om P; Nanda, Sanju

2016-03-01

The current studies entail systematic quality by design (QbD)-based development of simple, precise, cost-effective and stability-indicating high-performance liquid chromatography method for estimation of ketoprofen. Analytical target profile was defined and critical analytical attributes (CAAs) were selected. Chromatographic separation was accomplished with an isocratic, reversed-phase chromatography using C-18 column, pH 6.8, phosphate buffer-methanol (50 : 50v/v) as a mobile phase at a flow rate of 1.0 mL/min and UV detection at 258 nm. Systematic optimization of chromatographic method was performed using central composite design by evaluating theoretical plates and peak tailing as the CAAs. The method was validated as per International Conference on Harmonization guidelines with parameters such as high sensitivity, specificity of the method with linearity ranging between 0.05 and 250 µg/mL, detection limit of 0.025 µg/mL and quantification limit of 0.05 µg/mL. Precision was demonstrated using relative standard deviation of 1.21%. Stress degradation studies performed using acid, base, peroxide, thermal and photolytic methods helped in identifying the degradation products in the proniosome delivery systems. The results successfully demonstrated the utility of QbD for optimizing the chromatographic conditions for developing highly sensitive liquid chromatographic method for ketoprofen. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Stability Indicating Reverse Phase HPLC Method for Estimation of Rifampicin and Piperine in Pharmaceutical Dosage Form.

PubMed

Shah, Umang; Patel, Shraddha; Raval, Manan

2018-01-01

High performance liquid chromatography is an integral analytical tool in assessing drug product stability. HPLC methods should be able to separate, detect, and quantify the various drug-related degradants that can form on storage or manufacturing, plus detect any drug-related impurities that may be introduced during synthesis. A simple, economic, selective, precise, and stability-indicating HPLC method has been developed and validated for analysis of Rifampicin (RIFA) and Piperine (PIPE) in bulk drug and in the formulation. Reversed-phase chromatography was performed on a C18 column with Buffer (Potassium Dihydrogen Orthophosphate) pH 6.5 and Acetonitrile, 30:70), (%, v/v), as mobile phase at a flow rate of 1 mL min-1. The detection was performed at 341 nm and sharp peaks were obtained for RIFA and PIPE at retention time of 3.3 ± 0.01 min and 5.9 ± 0.01 min, respectively. The detection limits were found to be 2.385 ng/ml and 0.107 ng/ml and quantification limits were found to be 7.228ng/ml and 0.325ng/ml for RIFA and PIPE, respectively. The method was validated for accuracy, precision, reproducibility, specificity, robustness, and detection and quantification limits, in accordance with ICH guidelines. Stress study was performed on RIFA and PIPE and it was found that these degraded sufficiently in all applied chemical and physical conditions. Thus, the developed RP-HPLC method was found to be suitable for the determination of both the drugs in bulk as well as stability samples of capsule containing various excipients. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Sensitivity of stability indices to dealerting

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

Canavan, G.H.

1998-03-01

It is reported that more than 100 former or current heads of state and civilian leaders from around the world, including ex-presidents Jimmy Carter and Mikhail Gorbachev, have signed a statement that calls for removing nuclear weapons from alert status and other measures aimed at the eventual elimination of atomic arsenals--reflecting mounting support for the cause of nuclear bolition. This note uses stability analysis derived from current US and Russian analyses to study the impact of such dealerting on stability, indicating that it could be negative. Dealerting forces removes them from first and second strikes for as long as theymore » are dealerted. If they are dealerted for periods long compared to those involved in the evaluation of first strike stability, dealerting has the same effect as permanent arms reductions, it subtracts them from first and second strikes. Thus, it is conceptually a way of implementing such reductions on an accelerated scale. Dealerting strategic forces has been posited as a stabilizing step towards their abolition. Previous reports have shown that planned START reductions will reduce stability indices by about a factor of two. Dealerting would hasten those reductions. They would also raise the possibility that one side could realert faster than the other. If so, the remobilized forces could be used to damage limit, which would reduce his first strike cost and stability index. The impact of complete demobilization of SSBNs would be an order of magnitude reduction in the overall stability index, to a level set by alert ICBMs. Generally, it would be preferable to maintain any existing strategic forces at the highest level of alert to minimize this effect and to concentrate instead on decreasing their total number.« less

Relative performance of three stream bed stability indices as indicators of stream health.

PubMed

Kusnierz, Paul C; Holbrook, Christopher M

2017-10-16

Bed stability is an important stream habitat attribute because it affects geomorphology and biotic communities. Natural resource managers desire indices of bed stability that can be used under a wide range of geomorphic conditions, are biologically meaningful, and are easily incorporated into sampling protocols. To eliminate potential bias due to presence of instream wood and increase precision of stability values, we modified a stream bed instability index (ISI) to include measurements of bankfull depth (d bf ) and median particle diameter (D 50 ) only in riffles and increased the pebble count to decrease variability (i.e., increase precision) in D 50 . The new riffle-based instability index (RISI) was compared to two established indices: ISI and the riffle stability index (RSI). RISI and ISI were strongly associated with each other but neither was closely associated with RSI. RISI and ISI were closely associated with both a diatom- and two macrovertebrate-based stream health indices, but RSI was only weakly associated with the macroinvertebrate indices. Unexpectedly, precision of D 50 did not differ between RISI and ISI. Results suggest that RISI is a viable alternative to both ISI and RSI for evaluating bed stability in multiple stream types. With few data requirements and a simple protocol, RISI may also better conform to riffle-based sampling methods used by some water quality practitioners.

Relative performance of three stream bed stability indices as indicators of stream health

USGS Publications Warehouse

Kusnierz, Paul C; Holbrook, Christopher

2017-01-01

Bed stability is an important stream habitat attribute because it affects geomorphology and biotic communities. Natural resource managers desire indices of bed stability that can be used under a wide range of geomorphic conditions, are biologically meaningful, and are easily incorporated into sampling protocols. To eliminate potential bias due to presence of instream wood and increase precision of stability values, we modified a stream bed instability index (ISI) to include measurements of bankfull depth (dbf) and median particle diameter (D50) only in riffles and increased the pebble count to decrease variability (i.e., increase precision) in D50.The new riffle-based instability index (RISI) was compared to two established indices: ISI and the riffle stability index (RSI). RISI and ISI were strongly associated with each other but neither was closely associated with RSI. RISI and ISI were closely associated with both a diatom- and two macrovertebrate-based stream health indices, but RSI was only weakly associated with the macroinvertebrate indices. Unexpectedly, precision of D50 did not differ between RISI and ISI. Results suggest that RISI is a viable alternative to both ISI and RSI for evaluating bed stability in multiple stream types. With few data requirements and a simple protocol, RISI may also better conform to riffle-based sampling methods used by some water quality practitioners.

A comparison of four embedded validity indices for the RBANS in a memory disorders clinic.

PubMed

Paulson, Daniel; Horner, Michael David; Bachman, David

2015-05-01

This examination of four embedded validity indices for the Repeated Battery for the Assessment of Neuropsychological Status (RBANS) explores the potential utility of integrating cognitive and self-reported depressive measures. Examined indices include the proposed RBANS Performance Validity Index (RBANS PVI) and the Charleston Revised Index of Effort for the RBANS (CRIER). The CRIER represented the novel integration of cognitive test performance and depression self-report information. The sample included 234 patients without dementia who could be identified as having demonstrated either valid or invalid responding, based on standardized criteria. Sensitivity and specificity for invalid responding varied widely, with the CRIER emerging as the best all-around index (sensitivity = 0.84, specificity = 0.90, AUC = 0.94). Findings support the use of embedded response validity indices, and suggest that the integration of cognitive and self-report depression data may optimize detection of invalid responding among older Veterans. © The Author 2015. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

RBANS Validity Indices: a Systematic Review and Meta-Analysis.

PubMed

Shura, Robert D; Brearly, Timothy W; Rowland, Jared A; Martindale, Sarah L; Miskey, Holly M; Duff, Kevin

2018-05-16

Neuropsychology practice organizations have highlighted the need for thorough evaluation of performance validity as part of the neuropsychological assessment process. Embedded validity indices are derived from existing measures and expand the scope of validity assessment. The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) is a brief instrument that quickly allows a clinician to assess a variety of cognitive domains. The RBANS also contains multiple embedded validity indicators. The purpose of this study was to synthesize the utility of those indicators to assess performance validity. A systematic search was completed, resulting in 11 studies for synthesis and 10 for meta-analysis. Data were synthesized on four indices and three subtests across samples of civilians, service members, and veterans. Sufficient data for meta-analysis were only available for the Effort Index, and related analyses indicated optimal cutoff scores of ≥1 (AUC = .86) and ≥ 3 (AUC = .85). However, outliers and heterogeneity were present indicating the importance of age and evaluation context. Overall, embedded validity indicators have shown adequate diagnostic accuracy across a variety of populations. Recommendations for interpreting these measures and future studies are provided.

A Validated Stability Indicating RP-HPLC Method for the Determination of Emtricitabine, Tenofovir Disoproxil Fumarate, Elvitegravir and Cobicistat in Pharmaceutical Dosage Form

PubMed Central

Runja, Chinnalalaiah; Ravi Kumar, Pigili; Avanapu, Srinivasa Rao

2016-01-01

A new simple, rapid stability indicating assay method has been developed and validated for the determination of emtricitabine, tenofovir disoproxil fumarate, elvitegravir and cobicistat using reverse-phase high-performance liquid chromatography in their pharmaceutical dosage form. The chromatographic separation was performed on an ODS column (250 × 4.6 mm, 5 µm) using mobile phase A (potassium dihydrogen orthophosphate, pH adjusted to 2.5) and mobile phase B (acetonitrile) in the ratio of 55:45% v/v at a flow rate of 1 mL/min. The analytes were detected at 250 nm. The method was found to be linear in the concentration range of 2–12 µg/mL for EMT, 3–18 µg/mL for TNDF, 1.5–9 µg/mL for ELV and COB, with the coefficient value (R2) of >0.9990. The accuracy was measured via recovery studies and found to be acceptable, and the percentage recoveries were found in the range of 99.93–100.08 ± 0.5%. Forced degradation studies were also conducted, and the drugs were subjected to various stress conditions such as acid hydrolysis, base hydrolysis, oxidative, photolytic and thermal degradation. The proposed method was successfully validated and applied for the quantitative estimation of these drugs in both bulk and tablet dosage forms. PMID:26865655

Respiration and enzymatic activities as indicators of stabilization of sewage sludge composting.

PubMed

Nikaeen, Mahnaz; Nafez, Amir Hossein; Bina, Bijan; Nabavi, BiBi Fatemeh; Hassanzadeh, Akbar

2015-05-01

The objective of this work was to study the evolution of physico-chemical and microbial parameters in the composting process of sewage sludge (SS) with pruning wastes (PW) in order to compare these parameters with respect to their applicability in the evaluation of organic matter (OM) stabilization. To evaluate the composting process and organic matter stability, different microbial activities were compared during composting of anaerobically digested SS with two volumetric ratios, 1:1 and 3:1 of PW:SS and two aeration techniques including aerated static piles (ASP) and turned windrows (TW). Dehydrogenase activity, fluorescein diacetate hydrolysis, and specific oxygen uptake rate (SOUR) were used as microbial activity indices. These indices were compared with traditional parameters, including temperature, pH, moisture content, organic matter, and C/N ratio. The results showed that the TW method and 3:1 (PW:SS) proportion was superior to the ASP method and 1:1 proportion, since the former accelerate the composting process by catalyzing the OM stabilization. Enzymatic activities and SOUR, which reflect microbial activity, correlated well with temperature fluctuations. Based on these results it appears that SOUR and the enzymatic activities are useful parameters to monitor the stabilization of SS compost. Copyright © 2015 Elsevier Ltd. All rights reserved.

Development and validation of a stability-indicating size-indicating size-exclusion LC method for the determination of rhIFN-alpha2a in pharmaceutical formulations.

PubMed

Zimmermann, Estevan Sonego; da Silva, Lucélia Magalhães; Calegari, Guilherme Zanini; Stamm, Fernanda Pavani; Souto, Ricardo Bizogne; Dalmora, Sérgio Luiz

2013-01-01

A size-exclusion LC method was validated for the determination of interferon-a2a (rhlFN-alpha2a) in pharmaceutical formulations without interference from human serum albumin. Chromatographic separation was performed on a BioSep-SEC-S 2000 column (300 x 7.8 mm id). The mobile phase consisted of 0.001 M monobasic potassium phosphate, 0.008 M sodium phosphate dibasic; 0.2 M sodium chloride buffer, pH 7.4, run at a gradient flow rate and using photodiode array detection at 214 nm, was used. Chromatographic separation was achieved with a retention time of 17.2 min, and the analysis was linear over the concentration range of 1.98 to 198 microg/mL (r2 = 0.9996). The accuracy was 101.39%, with bias lower than 1.67%. The LOD and LOQ were 0.87 and 1.98 microg/mL, respectively. Moreover, method validation demonstrated acceptable results for precision and robustness. The method was applied to the assessment of rhlFN-alpha2a and related proteins in biopharmaceutical dosage forms, and the content/potencies were correlated to those given by a validated RP-LC method and an in vitro bioassay. It was concluded that use of the methods in conjunction allows a great improvement in monitoring stability and QC, thereby ensuring the therapeutic efficacy of the biotechnology-derived medicine.

Development and validation of a disease-specific scale to assess psychosocial well-being of patients living with unruptured intracranial aneurysm.

PubMed

Fujishima-Hachiya, Asami; Inoue, Tomoko

2012-12-01

Although the detection rate for unruptured intracranial aneurysm (UIA) has improved since the 1990s, the quality of life and psychosocial status of patients living with UIA have been negatively affected. However, a comprehensive assessment tool for UIA patients is still awaited. This study aimed to develop and validate a disease-specific scale to assess UIA patients' psychosocial well-being in their daily lives. On the basis of previous qualitative research, 52 items on a six-dimension scale were generated. After a pilot study, statistical analysis was conducted to examine construct validity-including convergent validity, discriminant and known-group validity, and internal reliability. Between 2010 and 2011, 124 patients across three hospitals in Japan were tested using a tentative scale. As a result of exploratory factor analysis, we identified 25 items based on five conceptually derived dimensions (psychological stability, trust in healthcare resources, satisfaction with the decision-making process, positive perception of self-management, and confidence in UIA knowledge) as a final psychosocial well-being scale for UIA patients (UIA-PW scale). Cronbach's alpha coefficients for each subscale ranged between .76 and .90, with .83 for the total score, which indicated satisfactory internal consistency. The total score for the UIA-PW scale correlated significantly with the existing quality of life and mental health scales, but it is important to note that psychological stability and positive perception of self-management were negatively correlated. Although additional investigation is needed, the UIA-PW scale shows reasonable validity and reliability in assessing psychosocial well-being of patients living with UIA.

Design and Validation of a Low-Cost Portable Device to Quantify Postural Stability.

PubMed

Zhu, Yong

2017-03-18

Measurement of the displacement of the center-of-pressure (COP) is an important tool used in biomechanics to assess postural stability and human balance. The goal of this research was to design and validate a low-cost portable device that can offer a quick indication of the state of postural stability and human balance related conditions. Approximate entropy (ApEn) values reflecting the amount of irregularity hiding in COP oscillations were used to calculate the index. The prototype adopted a portable design using the measurements of the load cells located at the four corners of a low-cost force platform. The test subject was asked to stand on the device in a quiet, normal, upright stance for 30 s with eyes open and subsequently for 30 s with eyes closed. Based on the COP displacement signals, the ApEn values were calculated. The results indicated that the prototype device was capable of capturing the increase in regularity of postural control in the visual-deprivation conditions. It was also able to decipher the subtle postural control differences along anterior-posterior and medial-lateral directions. The data analysis demonstrated that the prototype would enable the quantification of postural stability and thus provide a low-cost portable device to assess many conditions related to postural stability and human balance such as aging and pathologies.

Stability-indicating UPLC method for determination of Valsartan and their degradation products in active pharmaceutical ingredient and pharmaceutical dosage forms.

PubMed

Krishnaiah, Ch; Reddy, A Raghupathi; Kumar, Ramesh; Mukkanti, K

2010-11-02

A simple, precise, accurate stability-indicating gradient reverse phase ultra-performance liquid chromatographic (RP-UPLC) method was developed for the quantitative determination of purity of Valsartan drug substance and drug products in bulk samples and pharmaceutical dosage forms in the presence of its impurities and degradation products. The method was developed using Waters Aquity BEH C18 (100 mm x 2.1 mm, 1.7 microm) column with mobile phase containing a gradient mixture of solvents A and B. The eluted compounds were monitored at 225 nm, the run time was within 9.5 min, which Valsartan and its seven impurities were well separated. Valsartan was subjected to the stress conditions of oxidative, acid, base, hydrolytic, thermal and photolytic degradation. Valsartan was found to degrade significantly in acid and oxidative stress conditions and stable in base, hydrolytic and photolytic degradation conditions. The degradation products were well resolved from main peak and its impurities, proving the stability-indicating power of the method. The developed method was validated as per international conference on harmonization (ICH) guidelines with respect to specificity, linearity, limit of detection, limit of quantification, accuracy, precision and robustness. This method was also suitable for the assay determination of Valsartan in pharmaceutical dosage forms.

Assessing the validity and reliability of three indicators self-reported on the pregnancy risk assessment monitoring system survey.

PubMed

Ahluwalia, Indu B; Helms, Kristen; Morrow, Brian

2013-01-01

We investigated the reliability and validity of three self-reported indicators from the Pregnancy Risk Assessment Monitoring System (PRAMS) survey. We used 2008 PRAMS (n=15,646) data from 12 states that had implemented the 2003 revised U.S. Certificate of Live Birth. We estimated reliability by kappa coefficient and validity by sensitivity and specificity using the birth certificate data as the reference for the following: prenatal participation in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC); Medicaid payment for delivery; and breastfeeding initiation. These indicators were examined across several demographic subgroups. The reliability was high for all three measures: 0.81 for WIC participation, 0.67 for Medicaid payment of delivery, and 0.72 for breastfeeding initiation. The validity of PRAMS indicators was also high: WIC participation (sensitivity = 90.8%, specificity = 90.6%), Medicaid payment for delivery (sensitivity = 82.4%, specificity = 85.6%), and breastfeeding initiation (sensitivity = 94.3%, specificity = 76.0%). The prevalence estimates were higher on PRAMS than the birth certificate for each of the indicators except Medicaid-paid delivery among non-Hispanic black women. Kappa values within most subgroups remained in the moderate range (0.40-0.80). Sensitivity and specificity values were lower for Hispanic women who responded to the PRAMS survey in Spanish and for breastfeeding initiation among women who delivered very low birthweight and very preterm infants. The validity and reliability of the PRAMS data for measures assessed were high. Our findings support the use of PRAMS data for epidemiological surveillance, research, and planning.

Development of a Stability-Indicating Stereoselective Method for Quantification of the Enantiomer in the Drug Substance and Pharmaceutical Dosage Form of Rosuvastatin Calcium by an Enhanced Approach

PubMed Central

Rajendra Reddy, Gangireddy; Ravindra Reddy, Papammagari; Siva Jyothi, Polisetty

2015-01-01

A novel, simple, precise, and stability-indicating stereoselective method was developed and validated for the accurate quantification of the enantiomer in the drug substance and pharmaceutical dosage forms of Rosuvastatin Calcium. The method is capable of quantifying the enantiomer in the presence of other related substances. The chromatographic separation was achieved with an immobilized cellulose stationary phase (Chiralpak IB) 250 mm x 4.6 mm x 5.0 μm particle size column with a mobile phase containing a mixture of n-hexane, dichloromethane, 2-propanol, and trifluoroacetic acid in the ratio 82:10:8:0.2 (v/v/v/v). The eluted compounds were monitored at 243 nm and the run time was 18 min. Multivariate analysis and statistical tools were used to develop this highly robust method in a short span of time. The stability-indicating power of the method was established by subjecting Rosuvastatin Calcium to the stress conditions (forced degradation) of acid, base, oxidative, thermal, humidity, and photolytic degradation. Major degradation products were identified and found to be well-resolved from the enantiomer peak, proving the stability-indicating power of the method. The developed method was validated as per International Conference on Harmonization (ICH) guidelines with respect to specificity, limit of detection and limit of quantification, precision, linearity, accuracy, and robustness. The method exhibited consistent, high-quality recoveries (100 ± 10%) with a high precision for the enantiomer. Linear regression analysis revealed an excellent correlation between the peak responses and concentrations (r2 value of 0.9977) for the enantiomer. The method is sensitive enough to quantify the enantiomer above 0.04% and detect the enantiomer above 0.015% in Rosuvastatin Calcium. The stability tests were also performed on the drug substances as per ICH norms. PMID:26839815

Validation of the German prostate-specific module.

PubMed

Bestmann, Beate; Rohde, Volker; Siebmann, Jens-Ulrich; Galalae, Razvan; Weidner, Wolfgang; Küchler, Thomas

2006-02-01

Theoretically, all patients newly diagnosed with prostate cancer are faced with a choice of treatment options: radical prostatectomy or radio therapy. Although these different treatments may have no differences in terms of survival, they may have very different consequences on the subsequent quality of life (QoL). Prerequisite to analyze QoL is a reliable and valid instrument to assess these differences not only in terms of general QoL (EORTC QLQ-C30) but prostate specific symptoms with a prostate specific module as well. Therefore, the aim of this study was a psychometric evaluation (validation) of the prostate-specific module (PSM). Five historical cohort studies were put together for an empirical meta-analysis. The main objective was to analyze the module's psychometric properties. The total sample consisted of 1,185 patients, of whom 950 completed the QoL questionnaires (EORTC QLQ-C30 and a prostate specific module developed by Kuechler et al.). First step of analysis was a principal component analysis that revealed the following scales: urinary problems, incontinence, erectile dysfunction, sexual problems, problems with partner, pain, heat, nutrition, and psychic strain. The module showed good reliability and concurrent validity and very good construct validity, since the module is able to discriminate between different treatment regimes, tumor stages and age. The German PSM is a reliable, valid and applicable tool for QoL in patients with prostate cancer.

Identification and characterization of stress degradants of lacosamide by LC-MS and ESI-Q-TOF-MS/MS: development and validation of a stability indicating RP-HPLC method.

PubMed

Ramisetti, Nageswara Rao; Kuntamukkala, Ramakrishna; Lakshetti, Sridhar; Sripadi, Prabhakar

2014-07-01

The current study dealt with the degradation behavior of lacosamide (LAC) under ICH prescribed stress conditions. LAC was found to be labile under acid and base hydrolytic stress conditions, while it was stable to neutral hydrolytic, oxidative, photolytic and thermal stress. In total, seven degradation products (DPs) were formed, which were separated on a C18 column using a stability-indicating method. LC-MS analyses indicated that one of the DPs had the same molecular mass as that of the drug. Structural characterization of DPs was carried out using ESI-Q-TOF-MS/MS technique. The degradation pathways and mechanisms of degradation of the drug were delineated by carrying out the degradation in different co-solvents viz. methanol, deuterated methanol, ethanol, 1-propanol and acetonitrile. The developed LC method was validated for the determination of related substances and assay of LAC as per ICH guidelines. This study demonstrates a comprehensive approach of LAC degradation studies during its development phase. Copyright © 2014. Published by Elsevier B.V.

Development and validation of a novel stability-indicating HPLC method for the quantitative determination of eleven related substances in ezetimibe drug substance and drug product.

PubMed

Luo, Zhiqiang; Deng, Zhongqing; Liu, Yang; Wang, Guopeng; Yang, Wenning; Hou, Chengbo; Tang, Minming; Yang, Ruirui; Zhou, Huaming

2015-07-01

Ezetimibe is a novel lipid-lowering agent that inhibits intestinal absorption of dietary and biliary cholesterol. In the present work, a simple, sensitive and reproducible gradient reverse phase high performance liquid chromatographic (RP-HPLC) method for separation and determination of the related substances of ezetimibe was developed and validated. Eleven potential process-related impurities (starting materials, (3S,4S,3'S)-isomer, degradants and byproducts) were identified in the crude samples. Tentative structures for all the impurities were assigned primarily based on comparison of their retention time and mass spectrometric data with that of available standards and references. This method can be applied to routine analysis in quality control of both bulk drugs and commercial tablets. Separation of all these compounds was performed on a Phenomenex Luna Phenyl-Hexyl (100mm×4.6mm, 5μm) analytical column. The mobile phase-A consists of acetonitrile-water (pH adjusted to 4.0 with phosphoric acid)-methanol at 15:75:10 (v/v/v), and mobile phase-B contains acetonitrile. The eluted compounds were monitored at 210nm. Ezetimibe was subjected to hydrolytic, acid, base, oxidative, photolytic and thermal stress conditions as per ICH serves to generate degradation products that can be used as a worst case to assess the analytical method performance. The drug showed extensive degradation in thermal, acid, oxidative, base and hydrolytic stress conditions, while it was stable to photolytic degradation conditions. The main degradation product formed under thermal, acid, oxidative, base and hydrolytic stress conditions corresponding to (2R,3R,6S)-N, 6-bis(4-fluorophenyl)-2-(4-hydroxyphenyl)-oxane-3-carboxamide (Ezetimibe tetrahydropyran impurity) was characterized by LC-MS/MS analysis. The degradation products were well resolved from the main peak and its impurities, thus proved the stability-indicating power of the method. The developed method was validated as per

Assessing behavioural changes in ALS: cross-validation of ALS-specific measures.

PubMed

Pinto-Grau, Marta; Costello, Emmet; O'Connor, Sarah; Elamin, Marwa; Burke, Tom; Heverin, Mark; Pender, Niall; Hardiman, Orla

2017-07-01

The Beaumont Behavioural Inventory (BBI) is a behavioural proxy report for the assessment of behavioural changes in ALS. This tool has been validated against the FrSBe, a non-ALS-specific behavioural assessment, and further comparison of the BBI against a disease-specific tool was considered. This study cross-validates the BBI against the ALS-FTD-Q. Sixty ALS patients, 8% also meeting criteria for FTD, were recruited. All patients were evaluated using the BBI and the ALS-FTD-Q, completed by a carer. Correlational analysis was performed to assess construct validity. Precision, sensitivity, specificity, and overall accuracy of the BBI when compared to the ALS-FTD-Q, were obtained. The mean score of the whole sample on the BBI was 11.45 ± 13.06. ALS-FTD patients scored significantly higher than non-demented ALS patients (31.6 ± 14.64, 9.62 ± 11.38; p < 0.0001). A significant large positive correlation between the BBI and the ALS-FTD-Q was observed (r = 0.807, p < 0.0001), and no significant correlations between the BBI and other clinical/demographic characteristics indicate good convergent and discriminant validity, respectively. 72% of overall concordance was observed. Precision, sensitivity, and specificity for the classification of severely impaired patients were adequate. However, lower concordance in the classification of mild behavioural changes was observed, with higher sensitivity using the BBI, most likely secondary to BBI items which endorsed behavioural aspects not measured by the ALS-FTD-Q. Good construct validity has been further confirmed when the BBI is compared to an ALS-specific tool. Furthermore, the BBI is a more comprehensive behavioural assessment for ALS, as it measures the whole behavioural spectrum in this condition.

Stability-Indicating HPTLC Method for Studying Stress Degradation Behavior of Sulbutiamine HCl

PubMed Central

Farid, Nehal F.; Abdelwahab, Nada S.

2016-01-01

Sulbutiamine (SUL) is an ester of thiazides with neurotropic action. A new stability indicating HPTLC method has been developed and validated for the determination of SUL in the presence of different degradation products. The drug was subjected to different stress conditions following ICH strategy such as hydrolytic degradation (neutral, alkaline and acidic hydrolysis), oxidation, photodegradation and dry heat degradation. The drug demonstrated degradation under all decomposition conditions except neutral hydrolysis and dry heat, where the drug was completely degraded with 0.1 N NaOH, 1 N HCl and 30% H2O2 while it was partially degradaed by 0.1 N HCl, 3% H2O2 and UV light. Structure elucidation of the resulting degradation products was performed using ESI-Q-MS–MS. A well-defined peak for SUL was obtained at Rf = 0.46 and was completely separated from all obtained degradation products. Chromatographic separation was carried out on HPTLC aluminum plates precoated with silica gel 60 F254 using acetone–methylene chloride–ammonia buffer (pH 8.5 ± 0.2) (7:3:0.5, v/v) as a developing system. Densitometric scanning of the separated peaks was performed at 254 nm. System suitability testing parameters were calculated to ascertain the quality performance of the developed method. The method was validated with respect to USP guidelines regarding accuracy, precision, specificity, robustness and ruggedness. Good correlation coefficients were achieved in the range of 0.4–5.0 µg/band, and the limit of detection and limit of quantitation were found to be 0.11 and 0.33 µg/band, respectively. The utility of the suggested method was verified by application to Arcalion forte® tablets where no interference from additives was found. PMID:26759487

Stability-Indicating HPTLC Method for Studying Stress Degradation Behavior of Sulbutiamine HCl.

PubMed

Farid, Nehal F; Abdelwahab, Nada S

2016-04-01

Sulbutiamine (SUL) is an ester of thiazides with neurotropic action. A new stability indicating HPTLC method has been developed and validated for the determination of SUL in the presence of different degradation products. The drug was subjected to different stress conditions following ICH strategy such as hydrolytic degradation (neutral, alkaline and acidic hydrolysis), oxidation, photodegradation and dry heat degradation. The drug demonstrated degradation under all decomposition conditions except neutral hydrolysis and dry heat, where the drug was completely degraded with 0.1 N NaOH, 1 N HCl and 30% H2O2 while it was partially degradaed by 0.1 N HCl, 3% H2O2 and UV light. Structure elucidation of the resulting degradation products was performed using ESI-Q-MS-MS. A well-defined peak for SUL was obtained at Rf = 0.46 and was completely separated from all obtained degradation products. Chromatographic separation was carried out on HPTLC aluminum plates precoated with silica gel 60 F254 using acetone-methylene chloride-ammonia buffer (pH 8.5 ± 0.2) (7:3:0.5, v/v) as a developing system. Densitometric scanning of the separated peaks was performed at 254 nm. System suitability testing parameters were calculated to ascertain the quality performance of the developed method. The method was validated with respect to USP guidelines regarding accuracy, precision, specificity, robustness and ruggedness. Good correlation coefficients were achieved in the range of 0.4-5.0 µg/band, and the limit of detection and limit of quantitation were found to be 0.11 and 0.33 µg/band, respectively. The utility of the suggested method was verified by application to Arcalion forte® tablets where no interference from additives was found. © The Author 2016. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Evaluation of biologic occupational risk control practices: quality indicators development and validation.

PubMed

Takahashi, Renata Ferreira; Gryschek, Anna Luíza F P L; Izumi Nichiata, Lúcia Yasuko; Lacerda, Rúbia Aparecida; Ciosak, Suely Itsuko; Gir, Elucir; Padoveze, Maria Clara

2010-05-01

There is growing demand for the adoption of qualification systems for health care practices. This study is aimed at describing the development and validation of indicators for evaluation of biologic occupational risk control programs. The study involved 3 stages: (1) setting up a research team, (2) development of indicators, and (3) validation of the indicators by a team of specialists recruited to validate each attribute of the developed indicators. The content validation method was used for the validation, and a psychometric scale was developed for the specialists' assessment. A consensus technique was used, and every attribute that obtained a Content Validity Index of at least 0.75 was approved. Eight indicators were developed for the evaluation of the biologic occupational risk prevention program, with emphasis on accidents caused by sharp instruments and occupational tuberculosis prevention. The indicators included evaluation of the structure, process, and results at the prevention and biologic risk control levels. The majority of indicators achieved a favorable consensus regarding all validated attributes. The developed indicators were considered validated, and the method used for construction and validation proved to be effective. Copyright (c) 2010 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Mosby, Inc. All rights reserved.

Sensitivity and Specificity of Stability Criteria for Immediately Loaded Splinted Maxillary Implants.

PubMed

Wentaschek, Stefan; Scheller, Herbert; Schmidtmann, Irene; Hartmann, Sinsa; Weyhrauch, Michael; Weibrich, Gernot; Lehmann, Karl Martin

2015-10-01

To assess the suitability of dental implants for immediate loading, primary stability is usually evaluated intraoperatively. This retrospective study aimed to assess the suitability of three stability parameters - namely, insertion torque (IT), implant stability quotient (ISQ; measured by resonance frequency analysis), and Periotest (PT) values - as potential predictors for the risk of nonosseointegration of immediately loaded splinted implants. The stability parameters were routinely collected under immediate loading. Nineteen patients with 11 edentulous and 8 partially edentulous maxillae were treated with 105 dental implants, which were immediately loaded using temporary fixed dentures. The IT results, PT values, and ISQ results were recorded. Receiver operating characteristic analysis was performed to assess the quality of each parameter as a diagnostic test. After a 3-month observation period, 11 implants in four patients were not osseointegrated. The IT and ISQ (IT 25.0 ± 12.5 Ncm and 8.4 ± 2.3 Ncm; PT -1.5 ± 3.0 and +2.7 ± 3.0; and ISQ 62.6 ± 6.7 and 54.7 ± 6.2) differed significantly between the osseointegrated and failed implants (p < .005). The IT showed the greatest specificity at a sensitivity of 1 and the greatest area under the curve (AUC; 0.929), followed by the PT value (AUC = 0.836) and ISQ (AUC = 0.811). Among the intraoperative parameters analyzed, IT showed the highest specificity at a high sensitivity of 1. Therefore, the IT can be considered the most valid prognostic factor for osseointegration of immediately loaded splinted dental implants. © 2014 Wiley Periodicals, Inc.

Stability-indicating HPLC-DAD methods for determination of two binary mixtures: Rabeprazole sodium-mosapride citrate and rabeprazole sodium-itopride hydrochloride.

PubMed

El-Fatatry, Hamed M; Mabrouk, Mokhtar M; Hewala, Ismail I; Emam, Ehab H

2014-08-01

Two selective stability-indicating HPLC methods are described for determination of rabeprazole sodium (RZ)-mosapride citrate (MR) and RZ-itopride hydrochloride (IO) mixtures in the presence of their ICH-stress formed degradation products. Separations were achieved on X-Bridge C18 column using two mobile phases: the first for RZ-MR mixture consisted of acetonitrile: 0.025 M KH 2 PO 4 solution: TEA (30:69:1 v/v; pH 7.0); the second for RZ-IO mixture was at ratio of 25:74:1 (v/v; pH 9.25). The detection wavelength was 283 nm. The two methods were validated and validation acceptance criteria were met in all cases. Peak purity testing using contrast angle theory, relative absorbance and log  A versus the wavelengths plots were presented. The % recoveries of the intact drugs were between 99.1% and 102.2% with RSD% values less than 1.6%. Application of the proposed HPLC methods indicated that the methods could be adopted to follow the stability of their formulations.

Reliability, validity, sensitivity and specificity of Guajarati version of the Roland-Morris Disability Questionnaire.

PubMed

Nambi, S Gopal

2013-01-01

The most common instruments developed to assess the functional status of patients with Non specific low back pain is the Roland-Morris Disability Questionnaire (RMDQ). Clinical and epidemiological research related to low back pain in the Gujarati population would be facilitated by the availability of well-established outcome measures. To find the reliability, validity, sensitivity and specificity of the Gujarati version of the RMDQ for use in Non Specific Chronic low back pain. A reliability, validity, sensitivity and specificity study of Gujarati version of the Roland-Morris Disability Questionnaire (RMDQ). Thirty out patients with Non Specific Chronic low back pain were assessed by the RMDQ. Reliability is assessed by using internal consistency and the intra-class correlation coefficient (ICC). Internal construct validity is assessed by RASCH Analysis and external construct validity is assessed by association with pain and spinal movement. Clinical calculator was used to determine the sensitivity and specificity. Internal consistency of the RMDQ is found to be adequate (> 0.65) at both times, with high ICC's also at both time points. Internal construct validity of the scale is good, indicating a single underlying construct. Expected associations with pain and spinal movement confirm external construct validity. The Sensitivity and Specificity at cut off point of 0.5 was 80% and 84% with respectively positive predictive value (PPV) of 83.33% and negative predictive value (NPV) of 80.76%. The Questionnaire is at the ordinal level. The RMDQ is a one-dimensional, ordinal measure, which works well in the Gujarati population.

Soil aggregate stability as an indicator for eco-engineering effectiveness?

NASA Astrophysics Data System (ADS)

Graf, Frank

2015-04-01

Eco-engineering aims at stabilising soil and slopes by applying technical and biological measures. Engineering structures are commonly well defined, immediately usable and operative, and their stability effects quantifiable and verifiable. Differently, the use of plants requires more restrictive boundary conditions and the protection potential is rarely easily calculable and develop-ing as a function of growth rate. Although the use of vegetation is widely appreciated and their stabilising effect recognised, there is an increasing demand on sound facts on its efficiency, in particular, in relation to time. Conclusively, a certain necessity has been recognised to monitor, assess and quantify the effectiveness of ecological restora-tion measures in order to facilitate the transfer of technology and knowledge. Recent theoretical models emphasize the im-portance of taking an integrated monitoring approach that considers multiple variables. However, limited financial and time resources often prevent such comprehensive assessments. A solution to this problem may be to use integrated indicators that reflect multiple aspects and, therefore, allow extensive information on ecosystem status to be gathered in a relatively short time. Among various other indicators, such as fractal dimension of soil particle size distribution or microbiological parameters, soil aggregate stability seems the most appropriate indicator with regard to protecting slopes from superficial soil failure as it is critical to both plant growth and soil structure. Soil aggregation processes play a crucial role in re-establishing soil structure and function and, conclusively, for successful and sustainable re-colonisation. Whereas the key role of soil aggregate stability in ecosystem functioning is well known concerning water, gas, and nutrient fluxes, only limited information is available with regard to soil mechanical and geotechnical aspects. Correspondingly, in the last couple of years several studies

Validation of the French version of the Burn Specific Health Scale-Brief (BSHS-B) questionnaire.

PubMed

Gandolfi, S; Auquit-Auckbur, I; Panunzi, S; Mici, E; Grolleau, J-L; Chaput, B

2016-11-01

The Burn Specific Health Scale-Brief questionnaire is a widely validated tool for estimating the health related quality of life and for assessing the best multidisciplinary management of burn patients. The aim of this study was to translate the BSHS-B into French and to investigate its reliability and validity. According to the procedure proposed by the Scientific Advisory Committee of the Medical Outcomes Trust, the Burn Specific Health Scale-Brief (BSHS-B) was translated from the English version into French. In order to test the reliability of the French version of the BSHS-B, 53 burn patients French speakers completed the BSHS-B and SF-36 questionnaires from two to four years after burn. Ten of them have been re-tested at 6 months after the first evaluation. To evaluate clinical utility of the BSHS-F, internal consistency, construct validity (using SF-36) and stability in time were assessed using Cronbach's alpha statistic, Spearman rank test, and intra-class correlation coefficient respectively. The French version of the BSHS-B Cronbach's alpha coefficient was 0.93 and was >0.80 for all the sub-domains. French version of the BSHS-B and the SF-36 were positively correlated, all the associations were statistically significant (p<0.01). Intra-class correlation coefficients for test-retest ranged between 0.95 and 0.99 for the sub-domains. The intra-class correlation coefficient (ICC) for the total score was 0.98. The French version of the BSHS-B shows a robust rate of internal consistency, construct validity and stability in time, supporting its application in routine clinical practice as well as in international studies. Copyright © 2016 Elsevier Ltd and ISBI. All rights reserved.

Thirty-Year Stability and Predictive Validity of Vocational Interests

ERIC Educational Resources Information Center

Rottinghaus, Patrick J.; Coon, Kristin L.; Gaffey, Abigail R.; Zytowski, Donald G.

2007-01-01

This study reports a 30-year follow-up of 107 former high school juniors and seniors from a rural Midwestern community who completed the Kuder Occupational Interest Survey (KOIS) in 1975 and 2005. Absolute, intra-individual, and test-retest stability of interests, and predictive validity of occupations were examined. Results showed minor absolute…

Storage stability study of porcine hepatic and intestinal cytochrome P450 isoenzymes by use of a newly developed and fully validated highly sensitive HPLC-MS/MS method.

PubMed

Schelstraete, Wim; Devreese, Mathias; Croubels, Siska

2018-02-01

Microsomes are an ideal medium to investigate cytochrome P450 (CYP450) enzyme-mediated drug metabolism. However, before microsomes are prepared, tissues can be stored for a long time. Studies about the stability of these enzymes in porcine hepatic and intestinal tissues upon storage are lacking. To be able to investigate CYP450 stability in microsomes prepared from these tissues, a highly sensitive and rapid HPLC-MS/MS method for the simultaneous determination of six CYP450 metabolites in incubation medium was developed and validated. The metabolites, paracetamol (CYP1A), 7-hydroxy-coumarin (CYP2A), 1-hydroxy-midazolam (CYP3A), 4-hydroxy-tolbutamide (CYP2C), dextrorphan (CYP2D), and 6-hydroxy-chlorzoxazone (CYP2E) were extracted with ethyl acetate at pH 1.0, followed by evaporation and separation on an Agilent Zorbax Eclipse Plus C18 column. The method was fully validated in a GLP-compliant laboratory according to European guidelines and was highly sensitive (LOQ = 0.25-2.5 ng/mL), selective, had good precision (RSD-within, 1.0-9.1%; RSD-between, 1.0-18.4%) and accuracy (within-run, 83.3-102%; between-run, 78.5-102%), and showed no relative signal suppression and enhancement. Consequently, this method was applied to study the stability of porcine hepatic and intestinal CYP450 isoenzymes when tissues were stored at - 80 °C. The results indicate that porcine CYP450 isoenzymes are stable in tissues at least up to 4 months when snap frozen and stored at - 80 °C. Moreover, the results indicate differences in porcine CYP450 stability compared to rat, rabbit, and fish CYP450, as observed by other research groups, hence stressing the importance to investigate the CYP450 stability of a specific species.

Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) processing speed scores as measures of noncredible responding: The third generation of embedded performance validity indicators.

PubMed

Erdodi, Laszlo A; Abeare, Christopher A; Lichtenstein, Jonathan D; Tyson, Bradley T; Kucharski, Brittany; Zuccato, Brandon G; Roth, Robert M

2017-02-01

Research suggests that select processing speed measures can also serve as embedded validity indicators (EVIs). The present study examined the diagnostic utility of Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) subtests as EVIs in a mixed clinical sample of 205 patients medically referred for neuropsychological assessment (53.3% female, mean age = 45.1). Classification accuracy was calculated against 3 composite measures of performance validity as criterion variables. A PSI ≤79 produced a good combination of sensitivity (.23-.56) and specificity (.92-.98). A Coding scaled score ≤5 resulted in good specificity (.94-1.00), but low and variable sensitivity (.04-.28). A Symbol Search scaled score ≤6 achieved a good balance between sensitivity (.38-.64) and specificity (.88-.93). A Coding-Symbol Search scaled score difference ≥5 produced adequate specificity (.89-.91) but consistently low sensitivity (.08-.12). A 2-tailed cutoff on the Coding/Symbol Search raw score ratio (≤1.41 or ≥3.57) produced acceptable specificity (.87-.93), but low sensitivity (.15-.24). Failing ≥2 of these EVIs produced variable specificity (.81-.93) and sensitivity (.31-.59). Failing ≥3 of these EVIs stabilized specificity (.89-.94) at a small cost to sensitivity (.23-.53). Results suggest that processing speed based EVIs have the potential to provide a cost-effective and expedient method for evaluating the validity of cognitive data. Given their generally low and variable sensitivity, however, they should not be used in isolation to determine the credibility of a given response set. They also produced unacceptably high rates of false positive errors in patients with moderate-to-severe head injury. Combining evidence from multiple EVIs has the potential to improve overall classification accuracy. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Geometrical analysis of the LiCN vibrational dynamics: a stability geometrical indicator.

PubMed

Vergel, A; Benito, R M; Losada, J C; Borondo, F

2014-02-01

The vibrational dynamics of the LiNC/LiCN molecular system is examined making use of the Riemannian geometry. Stability and chaoticity are analyzed, in this context, by means of the Jacobi-Levi-Civita equations, derived from the Jacobi metric, and its solutions. A dynamical indicator, called stability geometrical indicator, is introduced in order to ascertain the dynamical characteristics of stability and chaos in the molecule under study.

What do conscientious people do? Development and validation of the Behavioral Indicators of Conscientiousness (BIC).

PubMed

Jackson, Joshua J; Wood, Dustin; Bogg, Tim; Walton, Kate E; Harms, Peter D; Roberts, Brent W

2010-08-01

Typical assessments of personality traits collapse behaviors, thoughts, and feelings into a single measure without distinguishing between these different manifestations. To address this lack of specification, the current study develops and validates a measure that assesses a number of broad behaviors associated with the personality trait of conscientiousness (the Behavioral Indicators of Conscientiousness; BIC). Findings suggest that the lower-order structure of conscientious behaviors is mostly similar to the lower-order structure in extant trait measures. Furthermore, a daily diary method was used to validate the BIC against frequency counts of conscientious behavior. Overall, the results identify specific behaviors that conscientious individuals tend to perform and highlight possible advantages of this approach over broad trait assessment.

Field Validation of the Stability Limit of a Multi MW Turbine

NASA Astrophysics Data System (ADS)

Kallesøe, Bjarne S.; Kragh, Knud A.

2016-09-01

Long slender blades of modern multi-megawatt turbines exhibit a flutter like instability at rotor speeds above a critical rotor speed. Knowing the critical rotor speed is crucial to a safe turbine design. The flutter like instability can only be estimated using geometrically non-linear aeroelastic codes. In this study, the estimated rotor speed stability limit of a 7 MW state of the art wind turbine is validated experimentally. The stability limit is estimated using Siemens Wind Powers in-house aeroelastic code, and the results show that the predicted stability limit is within 5% of the experimentally observed limit.

[Preventable drug-related morbidity: determining valid indicators for primary care in Portugal].

PubMed

Guerreiro, Mara Pereira; Cantrill, Judith A; Martins, Ana Paula

2007-01-01

Preventable drug-related morbidity (PDRM) indicators are operational measures of therapeutic risk management. These clinical indicators, which cover a wide range of drugs, combine process and outcome in the same instrument. They were developed in the US and have been validated for primary care settings in the US, UK and Canada. This study is part of a research programme; it aimed to determine a valid set of PDRM indicators for adult patients in primary care in Portugal. Face validity of 61 US and UK-derived indicators translated to Portuguese was preliminarily determined by means of a postal questionnaire using a purposive sample of four Portuguese pharmacists with different backgrounds. Preliminary content validity of indicators approved in the previous stage was determined by cross-checking each definition of PDRM with standard drug information sources in Portugal. Face and content validity of indicators yielded by preliminary work were then established by a 37 expert panel (20 community pharmacists and 17 general practitioners) using a two-round Delphi survey. Data were analysed using SPSS release 11.5. Nineteen indicators were ruled out in preliminary validation. Changes were made in the content of eight of the remaining 42 indicators; these were related to differences in the drugs being marketed and patterns of drug monitoring between countries. Thirty-five indicators were consensus approved as PDRM for adult patients in Portuguese primary care by the Delphi panel.

Evaluation of the stability indices for the thunderstorm forecasting in the region of Belgrade, Serbia

NASA Astrophysics Data System (ADS)

Vujović, D.; Paskota, M.; Todorović, N.; Vučković, V.

2015-07-01

The pre-convective atmosphere over Serbia during the ten-year period (2001-2010) was investigated using the radiosonde data from one meteorological station and the thunderstorm observations from thirteen SYNOP meteorological stations. In order to verify their ability to forecast a thunderstorm, several stability indices were examined. Rank sum scores (RSSs) were used to segregate indices and parameters which can differentiate between a thunderstorm and no-thunderstorm event. The following indices had the best RSS values: Lifted index (LI), K index (KI), Showalter index (SI), Boyden index (BI), Total totals (TT), dew-point temperature and mixing ratio. The threshold value test was used in order to determine the appropriate threshold values for these variables. The threshold with the best skill scores was chosen as the optimal. The thresholds were validated in two ways: through the control data set, and comparing the calculated indices thresholds with the values of indices for a randomly chosen day with an observed thunderstorm. The index with the highest skill for thunderstorm forecasting was LI, and then SI, KI and TT. The BI had the poorest skill scores.

Validation of quality indicators for the organization of palliative care: a modified RAND Delphi study in seven European countries (the Europall project).

PubMed

Woitha, Kathrin; Van Beek, Karen; Ahmed, Nisar; Jaspers, Birgit; Mollard, Jean M; Ahmedzai, Sam H; Hasselaar, Jeroen; Menten, Johan; Vissers, Kris; Engels, Yvonne

2014-02-01

Validated quality indicators can help health-care professionals to evaluate their medical practices in a comparative manner to deliver optimal clinical care. No international set of quality indicators to measure the organizational aspects of palliative care settings exists. To develop and validate a set of structure and process indicators for palliative care settings in Europe. A two-round modified RAND Delphi process was conducted to rate clarity and usefulness of a previously developed set of 110 quality indicators. In total, 20 multi-professional palliative care teams of centers of excellence from seven European countries. In total, 56 quality indicators were rated as useful. These valid quality indicators concerned the following domains: the definition of a palliative care service (2 quality indicators), accessibility to palliative care (16 quality indicators), specific infrastructure to deliver palliative care (8 quality indicators), symptom assessment tools (1 quality indicator), specific personnel in palliative care services (9 quality indicators), documentation methodology of clinical data (14 quality indicators), evaluation of quality and safety procedures (1 quality indicator), reporting of clinical activities (1 quality indicator), and education in palliative care (4 quality indicator). The modified RAND Delphi process resulted in 56 international face-validated quality indicators to measure and compare organizational aspects of palliative care. These quality indicators, aimed to assess and improve the organization of palliative care, will be pilot tested in palliative care settings all over Europe and be used in the EU FP7 funded IMPACT project.

Development and validation of a new condition-specific instrument for evaluation of smile esthetics-related quality of life.

PubMed

Saltovic, Ema; Lajnert, Vlatka; Saltovic, Sabina; Kovacevic Pavicic, Daniela; Pavlic, Andrej; Spalj, Stjepan

2018-03-01

Orofacial esthetics raises psychosocial issues. The purpose was to create and validate new short instrument for psychosocial impacts of altered smile esthetics. A team of an orthodontist, two prosthodontists, psychologist, and a dental student generated items that could draw up specific hypothetical psychosocial dimensions (69 items initially, 39 in final analysis). The sample consisted of 261 Caucasian subjects attending local high schools and university (26% male) aged 14 to 28 years that have self-administrated the designed questionnaire. Factorial analysis, Cronbach's alpha, Pearson correlation, paired samples t-test and analysis of variance were used for analyses of internal consistency, construct validity, responsiveness, and test-retest. Three dimensions of psychosocial impacts of altered smile esthetics were identified: dental self-consciousness, dental self-confidence and social contacts that can be best fitted by 12 items, 4 items in each dimension. Internal consistency was good (α in range 0.85-0.89). Good stability in test-retest was confirmed. In responsiveness testing, tooth whitening induced increase in dental self-confidence (P = 0.002), but no significant changes in other dimensions. The new instrument, Smile Esthetics-Related Quality of Life (SERQoL), is short and has proven to be a good indicator of psychosocial dimensions related to perception of smile esthetics. Smile Esthetics-Related Quality of Life questionnaire might have practical validity when applied in esthetic dental clinical procedures. © 2017 Wiley Periodicals, Inc.

[Validation of SHI Claims Data Exemplified by Gender-specific Diagnoses].

PubMed

Hartmann, J; Weidmann, C; Biehle, R

2016-10-01

Aim: Use of statutory health insurance (SHI) data in health services research is increasing steadily and questions of validity are gaining importance. Using gender-specific diagnosis as an example, the aim of this study was to estimate the prevalence of implausible diagnosis and demonstrate an internal validation strategy. Method: The analysis is based on the SHI data from Baden-Württemberg for 2012. Subject of validation are gender-specific outpatient diagnoses that mismatch with the gender of the insured. To uncover this implausibility, it is necessary to clarify whether the diagnosis or the gender is wrong. The validation criteria used were the presence of further gender-specific diagnoses, the presence of gender-specific settlement items, the specialization of the physician in charge and the gender assignment of the first name of the insured. To review the quality of the validation, it was verified if the gender was changed during the following year. Results: Around 5.1% of all diagnoses were gender-specific and there was a mismatch between diagnosis and gender in 0.04% of these cases. All validation criteria were useful to sort out implausibility, whereas the last one was the most effective. Only 14% remained unsolved. From the total of 1 145 insured with implausible gender-specific diagnoses, one year later 128 had a new gender (in the data). 119 of these cases were rightly classified as insured with wrong gender and 9 cases were in the unsolved group. This confirms that the validation works well. Conclusion: Implausibility in SHI data is relatively small and can be solved with appropriate validation criteria. When validating SHI data, it is advisable to question all data used critically, to use multiple validation criteria instead of just one and to abandon the idea that reality and the associated data conform to standardized norms. Keeping these aspects in mind, analysis of SHI data is a good starting point for research in health services. © Georg

Criterion Related Validity of Karate Specific Aerobic Test (KSAT).

PubMed

Chaabene, Helmi; Hachana, Younes; Franchini, Emerson; Tabben, Montassar; Mkaouer, Bessem; Negra, Yassine; Hammami, Mehrez; Chamari, Karim

2015-09-01

Karate is one the most popular combat sports in the world. Physical fitness assessment on a regular manner is important for monitoring the effectiveness of the training program and the readiness of karatekas to compete. The aim of this research was to examine the criterion related to validity of the karate specific aerobic test (KSAT) as an indicator of aerobic level of karate practitioners. Cardiorespiratory responses, aerobic performance level through both treadmill laboratory test and YoYo intermittent recovery test level 1 (YoYoIRTL1) as well as time to exhaustion in the KSAT test (TE'KSAT) were determined in a total of fifteen healthy international karatekas (i.e. karate practitioners) (means ± SD: age: 22.2 ± 4.3 years; height: 176.4 ± 7.5 cm; body mass: 70.3 ± 9.7 kg and body fat: 13.2 ± 6%). Peak heart rate obtained from KSAT represented ~99% of maximal heart rate registered during the treadmill test showing that KSAT imposes high physiological demands. There was no significant correlation between KSAT's TE and relative (mL/min kg) treadmill maximal oxygen uptake (r = 0.14; P = 0.69; [small]). On the other hand, there was a significant relationship between KSAT's TE and the velocity associated with VO2max (vVO2max) (r = 0.67; P = 0.03; [large]) as well as the velocity at VO2 corresponding to the second ventilatory threshold (vVO2 VAT) (r = 0.64; P = 0.04; [large]). Moreover, significant relationship was found between TE's KSAT and both the total distance covered and parameters of intermittent endurance measured through YoYoIRTL1. The KSAT has not proved to have indirect criterion related validity as no significant correlations have been found between TE's KSAT and treadmill VO2max. Nevertheless, as correlated to other aerobic fitness variables, KSAT can be considered as an indicator of karate specific endurance. The establishment of the criterion related validity of the KSAT requires further investigation.

[THERMAL STABILITY AS A PROGNOSTIC INDICATOR OF CONSERVATION OF LIVE EMBRYONIC SMALLPOX VACCINE (TEOVAC) DURING STORAGE].

PubMed

Zhukov, V A; Kokorev, S V; Rogozhkina, S V; Melnikov, D G; Terentiev, A I; Kovalchuk, E A; Vakhnov, E Yu; Borisevich, S V

2016-01-01

Determination of values of coefficients of thermal stability of TEOVac for prognosis of conservation of the vaccine (specific biological activity) during the process of warranty period storage. TEOVac (masticatory tablets) in primary packaging was kept at increased temperature (accelerated and stress-tests) and at the conditions established by PAP for the preparation (long-term tests). Biological activity of the vaccine was determined by titration on 12-day chicken embryos. A correlation between the value of coefficients of thermal stability and conservation of the prepared series of the condition preparation at the final date of storage was experimentally established. Coefficients of thermal stability could be used as a prognostic indicator of quality of the produced pelleted formulation of the preparation for evaluation of conservation of the vaccine during warranty period storage.

A New Rapid and Sensitive Stability-Indicating UPLC Assay Method for Tolterodine Tartrate: Application in Pharmaceuticals, Human Plasma and Urine Samples.

PubMed

Yanamandra, Ramesh; Vadla, Chandra Sekhar; Puppala, Umamaheshwar; Patro, Balaram; Murthy, Yellajyosula L N; Ramaiah, Parimi Atchuta

2012-01-01

A new rapid, simple, sensitive, selective and accurate reversed-phase stability-indicating Ultra Performance Liquid Chromatography (RP-UPLC) technique was developed for the assay of Tolterodine Tartrate in pharmaceutical dosage form, human plasma and urine samples. The developed UPLC method is superior in technology to conventional HPLC with respect to speed, solvent consumption, resolution and cost of analysis. Chromatographic run time was 6 min in reversed-phase mode and ultraviolet detection was carried out at 220 nm for quantification. Efficient separation was achieved for all the degradants of Tolterodine Tartrate on BEH C18 sub-2-μm Acquity UPLC column using Trifluoroacetic acid and acetonitrile as organic solvent in a linear gradient program. The active pharmaceutical ingredient was extracted from tablet dosage form using a mixture of acetonitrile and water as diluent. The calibration graphs were linear and the method showed excellent recoveries for bulk and tablet dosage form. The test solution was found to be stable for 40 days when stored in the refrigerator between 2 and 8 °C. The developed UPLC method was validated and meets the requirements delineated by the International Conference on Harmonization (ICH) guidelines with respect to linearity, accuracy, precision, specificity and robustness. The intra-day and inter-day variation was found be less than 1%. The method was reproducible and selective for the estimation of Tolterodine Tartrate. Because the method could effectively separate the drug from its degradation products, it can be employed as a stability-indicating one.

Stability-indicating HPLC Method for Simultaneous Determination of Terbutaline Sulphate, Bromhexine Hydrochloride and Guaifenesin

PubMed Central

Porel, A.; Haty, Sanjukta; Kundu, A.

2011-01-01

The aim of the present study was the development and subsequent validation of a simple, precise and stability-indicating reversed phase HPLC method for the simultaneous determination of guaifenesin, terbutaline sulphate and bromhexine hydrochloride in the presence of their potential impurities in a single run. The photolytic as well as hydrolytic impurities were detected as 3,5-dihydroxybenzoic acid, 3,5-dihydroxybenzaldehyde, 1-(3,5-dihydroxyphenyl)-2-[(1,1-dimethylethyl) amino]-ethanone from terbutaline, 2-methoxyphenol and an unknown impurity identified as (2RS)-3-(2-hydroxyphenoxy)-propane-1,2-diol from guaifenesin. The chromatographic separation of all the three active components and their impurities was achieved on Wakosil II column, using phosphate buffer (pH 3.0) and acetonitrile as mobile phase which was delivered initially in the ratio of 80:20 (v/v) for 18 min, then changed to 60:40 (v/v) for next 12 min, and finally equilibrated back to 80:20 (v/v) for 10 min. Other HPLC parameters were: Flow rate at 1.0 ml/min, detection wavelengths 248 and 280 nm, injection volume 10 μl. The calibration graphs plotted with five concentrations of each component were linear with a regression coefficient R2 >0.9999. The limit of detection and limit of quantitation were estimated for all the five impurities. The established method was then validated for linearity, precision, accuracy, and specificity and demonstrated to be applicable to the determination of the active ingredients in commercial and model cough syrup. No interference from the formulation excipients was observed. These results suggest that this LC method can be used for the determination of multiple active ingredients and their impurities in a cough and cold syrup. PMID:22131621

Stability-indicating HPLC Method for Simultaneous Determination of Terbutaline Sulphate, Bromhexine Hydrochloride and Guaifenesin.

PubMed

Porel, A; Haty, Sanjukta; Kundu, A

2011-01-01

The aim of the present study was the development and subsequent validation of a simple, precise and stability-indicating reversed phase HPLC method for the simultaneous determination of guaifenesin, terbutaline sulphate and bromhexine hydrochloride in the presence of their potential impurities in a single run. The photolytic as well as hydrolytic impurities were detected as 3,5-dihydroxybenzoic acid, 3,5-dihydroxybenzaldehyde, 1-(3,5-dihydroxyphenyl)-2-[(1,1-dimethylethyl) amino]-ethanone from terbutaline, 2-methoxyphenol and an unknown impurity identified as (2RS)-3-(2-hydroxyphenoxy)-propane-1,2-diol from guaifenesin. The chromatographic separation of all the three active components and their impurities was achieved on Wakosil II column, using phosphate buffer (pH 3.0) and acetonitrile as mobile phase which was delivered initially in the ratio of 80:20 (v/v) for 18 min, then changed to 60:40 (v/v) for next 12 min, and finally equilibrated back to 80:20 (v/v) for 10 min. Other HPLC parameters were: Flow rate at 1.0 ml/min, detection wavelengths 248 and 280 nm, injection volume 10 μl. The calibration graphs plotted with five concentrations of each component were linear with a regression coefficient R(2) >0.9999. The limit of detection and limit of quantitation were estimated for all the five impurities. The established method was then validated for linearity, precision, accuracy, and specificity and demonstrated to be applicable to the determination of the active ingredients in commercial and model cough syrup. No interference from the formulation excipients was observed. These results suggest that this LC method can be used for the determination of multiple active ingredients and their impurities in a cough and cold syrup.

Indications for spine surgery: validation of an administrative coding algorithm to classify degenerative diagnoses

PubMed Central

Lurie, Jon D.; Tosteson, Anna N.A.; Deyo, Richard A.; Tosteson, Tor; Weinstein, James; Mirza, Sohail K.

2014-01-01

Study Design Retrospective analysis of Medicare claims linked to a multi-center clinical trial. Objective The Spine Patient Outcomes Research Trial (SPORT) provided a unique opportunity to examine the validity of a claims-based algorithm for grouping patients by surgical indication. SPORT enrolled patients for lumbar disc herniation, spinal stenosis, and degenerative spondylolisthesis. We compared the surgical indication derived from Medicare claims to that provided by SPORT surgeons, the “gold standard”. Summary of Background Data Administrative data are frequently used to report procedure rates, surgical safety outcomes, and costs in the management of spinal surgery. However, the accuracy of using diagnosis codes to classify patients by surgical indication has not been examined. Methods Medicare claims were link to beneficiaries enrolled in SPORT. The sensitivity and specificity of three claims-based approaches to group patients based on surgical indications were examined: 1) using the first listed diagnosis; 2) using all diagnoses independently; and 3) using a diagnosis hierarchy based on the support for fusion surgery. Results Medicare claims were obtained from 376 SPORT participants, including 21 with disc herniation, 183 with spinal stenosis, and 172 with degenerative spondylolisthesis. The hierarchical coding algorithm was the most accurate approach for classifying patients by surgical indication, with sensitivities of 76.2%, 88.1%, and 84.3% for disc herniation, spinal stenosis, and degenerative spondylolisthesis cohorts, respectively. The specificity was 98.3% for disc herniation, 83.2% for spinal stenosis, and 90.7% for degenerative spondylolisthesis. Misclassifications were primarily due to codes attributing more complex pathology to the case. Conclusion Standardized approaches for using claims data to accurately group patients by surgical indications has widespread interest. We found that a hierarchical coding approach correctly classified over 90

Invalid before impaired: an emerging paradox of embedded validity indicators.

PubMed

Erdodi, Laszlo A; Lichtenstein, Jonathan D

Embedded validity indicators (EVIs) are cost-effective psychometric tools to identify non-credible response sets during neuropsychological testing. As research on EVIs expands, assessors are faced with an emerging contradiction: the range of credible impairment disappears between the 'normal' and 'invalid' range of performance. We labeled this phenomenon as the invalid-before-impaired paradox. This study was designed to explore the origin of this psychometric anomaly, subject it to empirical investigation, and generate potential solutions. Archival data were analyzed from a mixed clinical sample of 312 (M Age  = 45.2; M Education  = 13.6) patients medically referred for neuropsychological assessment. The distribution of scores on eight subtests of the third and fourth editions of Wechsler Adult Intelligence Scale (WAIS) were examined in relation to the standard normal curve and two performance validity tests (PVTs). Although WAIS subtests varied in their sensitivity to non-credible responding, they were all significant predictors of performance validity. While subtests previously identified as EVIs (Digit Span, Coding, and Symbol Search) were comparably effective at differentiating credible and non-credible response sets, their classification accuracy was driven by their base rate of low scores, requiring different cutoffs to achieve comparable specificity. Invalid performance had a global effect on WAIS scores. Genuine impairment and non-credible performance can co-exist, are often intertwined, and may be psychometrically indistinguishable. A compromise between the alpha and beta bias on PVTs based on a balanced, objective evaluation of the evidence that requires concessions from both sides is needed to maintain/restore the credibility of performance validity assessment.

Validation of a liquid chromatography method for the simultaneous determination of sulfadimethoxine and trimethoprim and application to a stability study.

PubMed

Louati, K; Mistiri, F; Kallel, M; Safta, F

2010-03-01

A liquid chromatography method is described for the simultaneous determination of sulfadimetoxine and trimethoprim from a veterinary formulation at the proportion of 187 mg and 40 mg respectively in presence of some excipient. The solution was subjected to different International Conference On Harmonisation prescribed stress conditions (hydrolysis, oxidation and photolysis). A stability-indicating high-performance liquid chromatography method was developed for the analysis of active substances in presence of their major degradation products. It involved a Knauer Eurospher C18 thermostated column at 25 degrees C, and 9.57 mM phosphate buffer (pH adjusted to 2.0 with orthophosphoric acid)-acetonitrile (70:30 v/v) as mobile phase. The mobile phase flow rate and sample volume injected were 1.2 mL/min and 20 microL, respectively. The selected wavelength for the determination was 248 nm. The method was validated for linearity, precision, accuracy and specificity, and then applied to a stability study of sulfadimetoxine and trimethoprim in the veterinary solution packaged in high density polyethylene plastic bottles of 1 L and 100 mL thermosealed and no thermosealed and corked by a white cap, at both accelerated and long-term conditions required by the International Conference On Harmonisation. The method developed, which separates all of the most degradation products formed under variety of conditions, proved to be simple, accurate, precise and specific. The results of the stress degradation show that the solution is more sensitive to hydrolysis. The stability studies carried out on three batches of each presentation show that the finished product remains stable for six months. Copyright 2010 Elsevier Masson SAS. All rights reserved.

[Validation and adhesion to GESIDA quality indicators in patients with HIV infection].

PubMed

Riera, Melchor; Esteban, Herminia; Suarez, Ignacio; Palacios, Rosario; Lozano, Fernando; Blanco, Jose R; Valencia, Eulalia; Ocampo, Antonio; Amador, Concha; Frontera, Guillem; vonWichmann-de Miguel, Miguel Angel

2016-01-01

The objective of the study is to validate the relevant GESIDA quality indicators for HIV infection, assessing the reliability, feasibility and adherence to them. The reliability was evaluated using the reproducibility of 6 indicators in peer review, with the second observer being an outsider. The feasibility and measurement of the level of adherence to the 22 indicators was conducted with annual fragmented retrospective collection of information from specific databases or the clinical charts of the nine participating hospitals. Reliability was very high, with interobserver agreement levels higher than 95% in 5 of the 6 indicators. The median time to achieve the indicators ranged between 5 and 600minutes, but could be achieved progressively from specific databases, enabling obtaining them automatically. As regards adherence to the indicators related with the initial evaluation of the patients, instructions and suitability of the guidelines for ART, adherence to ART, follow-up in clinics, and achieve an undetectable HIV by PCR at week 48 of the ART. Indicators of quality related to the prevention of opportunistic infections and control of comorbidities, the standards set were not achieved, and significant heterogeneity was observed between hospitals. The GESIDA quality indicators of HIV infection enabled the relevant indicators to be feasibly and reliably measured, and should be collected in all the units that care for patients with HIV infection. Copyright © 2015 Elsevier España, S.L.U. and Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.

Stability-based validation of dietary patterns obtained by cluster analysis.

PubMed

Sauvageot, Nicolas; Schritz, Anna; Leite, Sonia; Alkerwi, Ala'a; Stranges, Saverio; Zannad, Faiez; Streel, Sylvie; Hoge, Axelle; Donneau, Anne-Françoise; Albert, Adelin; Guillaume, Michèle

2017-01-14

Cluster analysis is a data-driven method used to create clusters of individuals sharing similar dietary habits. However, this method requires specific choices from the user which have an influence on the results. Therefore, there is a need of an objective methodology helping researchers in their decisions during cluster analysis. The objective of this study was to use such a methodology based on stability of clustering solutions to select the most appropriate clustering method and number of clusters for describing dietary patterns in the NESCAV study (Nutrition, Environment and Cardiovascular Health), a large population-based cross-sectional study in the Greater Region (N = 2298). Clustering solutions were obtained with K-means, K-medians and Ward's method and a number of clusters varying from 2 to 6. Their stability was assessed with three indices: adjusted Rand index, Cramer's V and misclassification rate. The most stable solution was obtained with K-means method and a number of clusters equal to 3. The "Convenient" cluster characterized by the consumption of convenient foods was the most prevalent with 46% of the population having this dietary behaviour. In addition, a "Prudent" and a "Non-Prudent" patterns associated respectively with healthy and non-healthy dietary habits were adopted by 25% and 29% of the population. The "Convenient" and "Non-Prudent" clusters were associated with higher cardiovascular risk whereas the "Prudent" pattern was associated with a decreased cardiovascular risk. Associations with others factors showed that the choice of a specific dietary pattern is part of a wider lifestyle profile. This study is of interest for both researchers and public health professionals. From a methodological standpoint, we showed that using stability of clustering solutions could help researchers in their choices. From a public health perspective, this study showed the need of targeted health promotion campaigns describing the benefits of healthy

11th GCC Closed Forum: cumulative stability; matrix stability; immunogenicity assays; laboratory manuals; biosimilars; chiral methods; hybrid LBA/LCMS assays; fit-for-purpose validation; China Food and Drug Administration bioanalytical method validation.

PubMed

Islam, Rafiq; Briscoe, Chad; Bower, Joseph; Cape, Stephanie; Arnold, Mark; Hayes, Roger; Warren, Mark; Karnik, Shane; Stouffer, Bruce; Xiao, Yi Qun; van der Strate, Barry; Sikkema, Daniel; Fang, Xinping; Tudoroniu, Ariana; Tayyem, Rabab; Brant, Ashley; Spriggs, Franklin; Barry, Colin; Khan, Masood; Keyhani, Anahita; Zimmer, Jennifer; Caturla, Maria Cruz; Couerbe, Philippe; Khadang, Ardeshir; Bourdage, James; Datin, Jim; Zemo, Jennifer; Hughes, Nicola; Fatmi, Saadya; Sheldon, Curtis; Fountain, Scott; Satterwhite, Christina; Colletti, Kelly; Vija, Jenifer; Yu, Mathilde; Stamatopoulos, John; Lin, Jenny; Wilfahrt, Jim; Dinan, Andrew; Ohorodnik, Susan; Hulse, James; Patel, Vimal; Garofolo, Wei; Savoie, Natasha; Brown, Michael; Papac, Damon; Buonarati, Mike; Hristopoulos, George; Beaver, Chris; Boudreau, Nadine; Williard, Clark; Liu, Yansheng; Ray, Gene; Warrino, Dominic; Xu, Allan; Green, Rachel; Hayward-Sewell, Joanne; Marcelletti, John; Sanchez, Christina; Kennedy, Michael; Charles, Jessica St; Bouhajib, Mohammed; Nehls, Corey; Tabler, Edward; Tu, Jing; Joyce, Philip; Iordachescu, Adriana; DuBey, Ira; Lindsay, John; Yamashita, Jim; Wells, Edward

2018-04-01

The 11th Global CRO Council Closed Forum was held in Universal City, CA, USA on 3 April 2017. Representatives from international CRO members offering bioanalytical services were in attendance in order to discuss scientific and regulatory issues specific to bioanalysis. The second CRO-Pharma Scientific Interchange Meeting was held on 7 April 2017, which included Pharma representatives' sharing perspectives on the topics discussed earlier in the week with the CRO members. The issues discussed at the meetings included cumulative stability evaluations, matrix stability evaluations, the 2016 US FDA Immunogenicity Guidance and recent and unexpected FDA Form 483s on immunogenicity assays, the bioanalytical laboratory's role in writing PK sample collection instructions, biosimilars, CRO perspectives on the use of chiral versus achiral methods, hybrid LBA/LCMS assays, applications of fit-for-purpose validation and, at the Global CRO Council Closed Forum only, the status and trend of current regulated bioanalytical practice in China under CFDA's new BMV policy. Conclusions from discussions of these topics at both meetings are included in this report.

Specifications and programs for computer software validation

NASA Technical Reports Server (NTRS)

Browne, J. C.; Kleir, R.; Davis, T.; Henneman, M.; Haller, A.; Lasseter, G. L.

1973-01-01

Three software products developed during the study are reported and include: (1) FORTRAN Automatic Code Evaluation System, (2) the Specification Language System, and (3) the Array Index Validation System.

Reliability and Concurrent Validity of Dynamic Rotator Stability Test-A Cross Sectional study.

PubMed

Binoy Mathew, K V; Eapen, Charu; Kumar, P Senthil

2012-01-01

To find intra rater and inter rater reliability of Dynamic Rotator Stability Test (DRST) and to find concurrent validity of Dynamic Rotator Stability Test (DRST) with University of Pennsylvania Shoulder Score (PENN) Scale. 40 subjects of either gender between the age group of 18-70 with painful shoulder conditions of musculoskeletal origin was selected through convenient sampling. Tester 1 and tester 2 administered DRST and PENN scale randomly. In a subgroup of 20 subjects DRST was administered by both the testers to find the inter rater reliability. 180° Standard Universal Goniometer was used to take measurements. For intra-rater reliability, all the test variables were showing highly significant correlation (p=.94 - 1). For inter -rater, with tester 2, test variables like position, ROM, force, direction of abnormal translation, pain during the test, compensatory movement during test were found to be significant (p=.71-1).only some variables of DRST showed significant correlation with PENN scale (P=.320-.450). Dynamic Rotator Stability Test has good intra rater and moderate inter rater reliability. Concurrent validity of Dynamic Rotator Stability Test was found to be poor when compared to PENN Shoulder Score.

Double Cross-Validation in Multiple Regression: A Method of Estimating the Stability of Results.

ERIC Educational Resources Information Center

Rowell, R. Kevin

In multiple regression analysis, where resulting predictive equation effectiveness is subject to shrinkage, it is especially important to evaluate result replicability. Double cross-validation is an empirical method by which an estimate of invariance or stability can be obtained from research data. A procedure for double cross-validation is…

Simultaneous determination of some water-soluble vitamins and preservatives in multivitamin syrup by validated stability-indicating high-performance liquid chromatography method.

PubMed

Vidović, Stojanka; Stojanović, Biljana; Veljković, Jelena; Prazić-Arsić, Ljiljana; Roglić, Goran; Manojlović, Dragan

2008-08-22

HPLC stability-indicating method has been developed for the simultaneous determination of some water-soluble vitamins (ascorbic acid, thiamine hydrochloride, riboflavin-5'-phosphate sodium, pyridoxine hydrochloride, nicotinamide, D(+)-panthenol) and two preservatives (methylparaben and sodium benzoate) in multivitamin syrup preparation. Water-soluble vitamins, preservatives and their degradants were separated on Zorbax SB-Aq (C(18)) (250 mm x 4.6 mm, 5 microm) column at an ambient temperature. Combined isocratic and gradient elution was performed with a mobile phase consisting of 0.0125 M hexane-1-sulfonic acid sodium salt in 0.1% (m/v) o-phosphoric acid, pH 2.4-2.5 (solvent A) and acetonitrile (solvent B) at the flow-rate 1 ml min(-1). Starting with solvent A an isocratic elution was performed for 15 min, then the composition was changed to 85% of A and 15% of B during the next 20 min and it was constant for 5 min, then the composition was changed to 70% of A and 30% of B during next 15 min and it was constant for 5 min and finally was changed to 100% of A as at the beginning of the elution. Detection was performed with diode array detector at 210, 230 and 254 nm. Multivitamin syrup preparation was subjected to stress testing (forced degradation) in order to demonstrate that degradants from the vitamins, preservatives and/or product excipients do not interfere with the quantification of vitamins and preservatives. Typical validation characteristics: selectivity, accuracy, precision, linearity, range, limit of quantification and limit of detection were evaluated for vitamins and preservatives.

Test of the Hill Stability Criterion against Chaos Indicators

NASA Astrophysics Data System (ADS)

Satyal, Suman; Quarles, Billy; Hinse, Tobias

2012-10-01

The efficacy of Hill Stability (HS) criterion is tested against other known chaos indicators such as Maximum Lyapunov Exponents (MLE) and Mean Exponential Growth of Nearby Orbits (MEGNO) maps. First, orbits of four observationally verified binary star systems: γ Cephei, Gliese-86, HD41004, and HD196885 are integrated using standard integration packages (MERCURY, SWIFTER, NBI, C/C++). The HS which measures orbital perturbation of a planet around the primary star due to the secondary star is calculated for each system. The LEs spectra are generated to measure the divergence/convergence rate of stable manifolds and the MEGNO maps are generated by using the variational equations of the system during the integration process. These maps allow to accurately differentiate between stable and unstable dynamical systems. Then the results obtained from the analysis of HS, MLE, and MEGNO maps are checked for their dynamical variations and resemblance. The HS of most of the planets seems to be stable, quasi-periodic for at least ten million years. The MLE and the MEGNO maps also indicate the local quasi-periodicity and global stability in relatively short integration period. The HS criterion is found to be a comparably efficient tool to measure the stability of planetary orbits.

Reliability and Factorial Validity of Non-Specific and Tennis-Specific Pre-Planned Agility Tests; Preliminary Analysis

PubMed Central

Sekulic, Damir; Uljevic, Ognjen; Peric, Mia; Spasic, Miodrag; Kondric, Miran

2017-01-01

Abstract Agility is an important quality in tennis, yet there is an evident lack of studies focussing on the applicability of tennis-specific agility performances and comparing them to equivalent non-specific agility performances. The aim of this study was to evaluate the reliability and factorial validity of three tests of pre-planned agility, performed in specific (with a tennis racquet) and non-specific (without a tennis racquet) conditions. The sample consisted of 33 tennis players (13 males and 20 females; age: 18.3 ± 1.1 years and 18.6 ± 1.3 years; body height: 185.4 ± 51 cm and 169.3 ± 4.2 cm, 74.0 ± 4.4 kg and 61.2 ± 3.1 kg, respectively). The variables comprised three agility tests: a 20-yard test, a T-test and the Illinois test, all performed in both specific and non-specific conditions. Between-subject and within-subject reliability were found to be high (Cronbach Alpha: 0.93 to 0.98; Coefficient of Variation: 3 to 8%), with better within-subject reliability and stability of the measurement for specific tests. Pearson’s product moment correlations between the non-specific and specific agility performances were high (r ≥0.84), while factor analysis extracted only one significant latent dimension on the basis of the Guttman-Kaiser criterion. The results of the 20-yard test were better when the test was conducted in the specific conditions (t-test = 2.66; p < 0.05). For the Illinois test, superior results were recorded in the non-specific conditions (t-test = 2.96; p < 0.05), which can be explained by the test duration (about 20 s) and non-specific locomotion forms such as rotational movements. Considering the findings of the present study, when testing tennis-specific pre-planned agility, we suggest using tests of short duration (less than 10 s) and sport-specific types of locomotion. PMID:28210343

Prevalence of Invalid Performance on Baseline Testing for Sport-Related Concussion by Age and Validity Indicator.

PubMed

Abeare, Christopher A; Messa, Isabelle; Zuccato, Brandon G; Merker, Bradley; Erdodi, Laszlo

2018-03-12

Estimated base rates of invalid performance on baseline testing (base rates of failure) for the management of sport-related concussion range from 6.1% to 40.0%, depending on the validity indicator used. The instability of this key measure represents a challenge in the clinical interpretation of test results that could undermine the utility of baseline testing. To determine the prevalence of invalid performance on baseline testing and to assess whether the prevalence varies as a function of age and validity indicator. This retrospective, cross-sectional study included data collected between January 1, 2012, and December 31, 2016, from a clinical referral center in the Midwestern United States. Participants included 7897 consecutively tested, equivalently proportioned male and female athletes aged 10 to 21 years, who completed baseline neurocognitive testing for the purpose of concussion management. Baseline assessment was conducted with the Immediate Postconcussion Assessment and Cognitive Testing (ImPACT), a computerized neurocognitive test designed for assessment of concussion. Base rates of failure on published ImPACT validity indicators were compared within and across age groups. Hypotheses were developed after data collection but prior to analyses. Of the 7897 study participants, 4086 (51.7%) were male, mean (SD) age was 14.71 (1.78) years, 7820 (99.0%) were primarily English speaking, and the mean (SD) educational level was 8.79 (1.68) years. The base rate of failure ranged from 6.4% to 47.6% across individual indicators. Most of the sample (55.7%) failed at least 1 of 4 validity indicators. The base rate of failure varied considerably across age groups (117 of 140 [83.6%] for those aged 10 years to 14 of 48 [29.2%] for those aged 21 years), representing a risk ratio of 2.86 (95% CI, 2.60-3.16; P < .001). The results for base rate of failure were surprisingly high overall and varied widely depending on the specific validity indicator and the age of the

Spectrofluorimetric methods of stability-indicating assay of certain drugs affecting the cardiovascular system

NASA Astrophysics Data System (ADS)

Moussa, B. A.; Mohamed, M. F.; Youssef, N. F.

2011-01-01

Two stability-indicating spectrofluorimetric methods have been developed for the determination of ezetimibe and olmesartan medoxomil, drugs affecting the cardiovascular system, and validated in the presence of their degradation products. The first method, for ezetimibe, is based on an oxidative coupling reaction of ezetimibe with 3-methylbenzothiazolin-2-one hydrazone hydrochloride in the presence of cerium (IV) ammonium sulfate in an acidic medium. The quenching effect of ezetimibe on the fluorescence of excess cerous ions is measured at the emission wavelength, λem, of 345 nm with the excitation wavelength, λex, of 296 nm. Factors affecting the reaction were carefully studied and optimized. The second method, for olmesartan medoxomil, is based on measuring the native fluorescence intensity of olmesartan medoxomil in methanol at λem = 360 nm with λex = 286 nm. Regression plots revealed good linear relationships in the assay limits of 10-120 and 8-112 g/ml for ezetimibe and olmesartan medoxomil, respectively. The validity of the methods was assessed according to the United States Pharmacopeya guidelines. Statistical analysis of the results exposed good Student's t-test and F-ratio values. The introduced methods were successfully applied to the analysis of ezetimibe and olmesartan medoxomil in drug substances and drug products as well as in the presence of their degradation products.

Criterion Related Validity of Karate Specific Aerobic Test (KSAT)

PubMed Central

Chaabene, Helmi; Hachana, Younes; Franchini, Emerson; Tabben, Montassar; Mkaouer, Bessem; Negra, Yassine; Hammami, Mehrez; Chamari, Karim

2015-01-01

Background: Karate is one the most popular combat sports in the world. Physical fitness assessment on a regular manner is important for monitoring the effectiveness of the training program and the readiness of karatekas to compete. Objectives: The aim of this research was to examine the criterion related to validity of the karate specific aerobic test (KSAT) as an indicator of aerobic level of karate practitioners. Patients and Methods: Cardiorespiratory responses, aerobic performance level through both treadmill laboratory test and YoYo intermittent recovery test level 1 (YoYoIRTL1) as well as time to exhaustion in the KSAT test (TE’KSAT) were determined in a total of fifteen healthy international karatekas (i.e. karate practitioners) (means ± SD: age: 22.2 ± 4.3 years; height: 176.4 ± 7.5 cm; body mass: 70.3 ± 9.7 kg and body fat: 13.2 ± 6%). Results: Peak heart rate obtained from KSAT represented ~99% of maximal heart rate registered during the treadmill test showing that KSAT imposes high physiological demands. There was no significant correlation between KSAT’s TE and relative (mL/min kg) treadmill maximal oxygen uptake (r = 0.14; P = 0.69; [small]). On the other hand, there was a significant relationship between KSAT’s TE and the velocity associated with VO2max (vVO2max) (r = 0.67; P = 0.03; [large]) as well as the velocity at VO2 corresponding to the second ventilatory threshold (vVO2 VAT) (r = 0.64; P = 0.04; [large]). Moreover, significant relationship was found between TE’s KSAT and both the total distance covered and parameters of intermittent endurance measured through YoYoIRTL1. Conclusions: The KSAT has not proved to have indirect criterion related validity as no significant correlations have been found between TE’s KSAT and treadmill VO2max. Nevertheless, as correlated to other aerobic fitness variables, KSAT can be considered as an indicator of karate specific endurance. The establishment of the criterion related validity of the KSAT

A New Rapid and Sensitive Stability-Indicating UPLC Assay Method for Tolterodine Tartrate: Application in Pharmaceuticals, Human Plasma and Urine Samples

PubMed Central

Yanamandra, Ramesh; Vadla, Chandra Sekhar; Puppala, Umamaheshwar; Patro, Balaram; Murthy, Yellajyosula. L. N.; Ramaiah, Parimi Atchuta

2012-01-01

A new rapid, simple, sensitive, selective and accurate reversed-phase stability-indicating Ultra Performance Liquid Chromatography (RP-UPLC) technique was developed for the assay of Tolterodine Tartrate in pharmaceutical dosage form, human plasma and urine samples. The developed UPLC method is superior in technology to conventional HPLC with respect to speed, solvent consumption, resolution and cost of analysis. Chromatographic run time was 6 min in reversed-phase mode and ultraviolet detection was carried out at 220 nm for quantification. Efficient separation was achieved for all the degradants of Tolterodine Tartrate on BEH C18 sub-2-μm Acquity UPLC column using Trifluoroacetic acid and acetonitrile as organic solvent in a linear gradient program. The active pharmaceutical ingredient was extracted from tablet dosage form using a mixture of acetonitrile and water as diluent. The calibration graphs were linear and the method showed excellent recoveries for bulk and tablet dosage form. The test solution was found to be stable for 40 days when stored in the refrigerator between 2 and 8 °C. The developed UPLC method was validated and meets the requirements delineated by the International Conference on Harmonization (ICH) guidelines with respect to linearity, accuracy, precision, specificity and robustness. The intra-day and inter-day variation was found be less than 1%. The method was reproducible and selective for the estimation of Tolterodine Tartrate. Because the method could effectively separate the drug from its degradation products, it can be employed as a stability-indicating one. PMID:22396907

Taking the Next Step: Combining Incrementally Valid Indicators to Improve Recidivism Prediction

ERIC Educational Resources Information Center

Walters, Glenn D.

2011-01-01

The possibility of combining indicators to improve recidivism prediction was evaluated in a sample of released federal prisoners randomly divided into a derivation subsample (n = 550) and a cross-validation subsample (n = 551). Five incrementally valid indicators were selected from five domains: demographic (age), historical (prior convictions),…

Sound quality indicators for urban places in Paris cross-validated by Milan data.

PubMed

Ricciardi, Paola; Delaitre, Pauline; Lavandier, Catherine; Torchia, Francesca; Aumond, Pierre

2015-10-01

A specific smartphone application was developed to collect perceptive and acoustic data in Paris. About 3400 questionnaires were analyzed, regarding the global sound environment characterization, the perceived loudness of some emergent sources and the presence time ratio of sources that do not emerge from the background. Sound pressure level was recorded each second from the mobile phone's microphone during a 10-min period. The aim of this study is to propose indicators of urban sound quality based on linear regressions with perceptive variables. A cross validation of the quality models extracted from Paris data was carried out by conducting the same survey in Milan. The proposed sound quality general model is correlated with the real perceived sound quality (72%). Another model without visual amenity and familiarity is 58% correlated with perceived sound quality. In order to improve the sound quality indicator, a site classification was performed by Kohonen's Artificial Neural Network algorithm, and seven specific class models were developed. These specific models attribute more importance on source events and are slightly closer to the individual data than the global model. In general, the Parisian models underestimate the sound quality of Milan environments assessed by Italian people.

How electrostatic networks modulate specificity and stability of collagen.

PubMed

Zheng, Hongning; Lu, Cheng; Lan, Jun; Fan, Shilong; Nanda, Vikas; Xu, Fei

2018-06-12

One-quarter of the 28 types of natural collagen exist as heterotrimers. The oligomerization state of collagen affects the structure and mechanics of the extracellular matrix, providing essential cues to modulate biological and pathological processes. A lack of high-resolution structural information limits our mechanistic understanding of collagen heterospecific self-assembly. Here, the 1.77-Å resolution structure of a synthetic heterotrimer demonstrates the balance of intermolecular electrostatics and hydrogen bonding that affects collagen stability and heterospecificity of assembly. Atomistic simulations and mutagenesis based on the solved structure are used to explore the contributions of specific interactions to energetics. A predictive model of collagen stability and specificity is developed for engineering novel collagen structures.

Frequency Discrimination Deficits in People with Specific Language Impairment: Reliability, Validity, and Linguistic Correlates

ERIC Educational Resources Information Center

McArthur, G. M.; Bishop, D. V. M.

2004-01-01

The reliability and validity of a frequency discrimination (FD) task were tested in 16 people with specific language impairment (SLI) and 16 people with normal spoken language (controls). The FD thresholds of the 2 groups indicated that FD thresholds for 25-ms and 250-ms tones were remarkably stable across 18 months. The FD thresholds were lower…

Elbow-specific clinical rating systems: extent of established validity, reliability, and responsiveness.

PubMed

The, Bertram; Reininga, Inge H F; El Moumni, Mostafa; Eygendaal, Denise

2013-10-01

The modern standard of evaluating treatment results includes the use of rating systems. Elbow-specific rating systems are frequently used in studies aiming at elbow-specific pathology. However, proper validation studies seem to be relatively sparse. In addition, these scoring systems might not always be used for appropriate populations of interest. Both of these issues might give rise to invalid conclusions being reported in the literature. Our aim was to investigate the extent to which the available elbow-specific outcome measurement tools have been validated and the quality of the validation itself. We also aimed to provide characteristics of the populations used for validation of these scales to enable clinicians to use them appropriately. A literature search identified 17 studies of 12 different elbow-specific scoring systems. These were assessed for validity, reliability, and responsiveness characteristics. The quality of these assessments was rated according to the Consensus Based Standards for the Selection of Health Measurement Instruments (COSMIN) checklist criteria, a standardized and validated tool developed specifically for this purpose. Currently, the only elbow-specific rating system that is validated using high-quality methodology is the Oxford Elbow Score, a patient-administered outcome measure tool that has been validated on heterogeneous study populations. Other rating systems still have to be proven in the future to be as good as the Oxford Elbow Score for clinical or research purposes. Additional validation studies are needed. Copyright © 2013 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Mosby, Inc. All rights reserved.

Clinical validity of a disease-specific health status questionnaire: the peripheral artery questionnaire.

PubMed

Hoeks, Sanne E; Smolderen, Kim G; Scholte Op Reimer, Wilma J M; Verhagen, Hence J M; Spertus, John A; Poldermans, Don

2009-02-01

Measuring patient-centered outcomes is becoming increasingly important in patients with peripheral arterial disease (PAD), both as a means of determining the benefits of treatment and as an aid for disease management. In order to monitor health status in a reliable and sensitive way, the disease-specific measure Peripheral Artery Questionnaire (PAQ) was developed. However, to date, its correlation with traditional clinical indices is unknown. The primary aim of this study was to better establish the clinical validity of the PAQ by examining its association with functional indices related to PAD. Furthermore, we hypothesized that the clinical validity of this disease-specific measure is better as compared with the EuroQol-5-dimensional (EQ-5D), a standardized generic instrument. Data on 711 consecutive PAD patients undergoing surgery were collected from 11 Dutch hospitals in 2004. At 3-year follow-up, questionnaires including the PAQ, EQ-5D, and EuroQol-Visual Analogue Scale (EQ VAS) were completed in 84% of survivors. The PAQ was analyzed according to three domains, as established by a factor analyses in the Dutch population, and the summary score. Baseline clinical indices included the presence and severity of claudication intermittent (CI) and the Lee Cardiac Risk Index. All three PAQ domains (Physical Function, Perceived Disability, and Treatment Satisfaction) were significantly associated with CI symptoms (P values < .001-.008). Patients with claudication had significant lower PAQ summary scores as compared with asymptomatic patients (58.6 +/- 27.8 vs 68.6 +/- 27.8, P = < .001). Furthermore, the PAQ summary score and the subscale scores for Physical Functioning and Perceived Disability demonstrated a clear dose-response relation for walking distance and the Lee Risk Index (P values < .001-.031). With respect to the generic EQ-5D, the summary EQ-5D index was associated with CI (0.81 +/- 0.20 vs 0.76 +/- 0.24, P = .031) but not with walking distance (P = .128

Comparison of five cluster validity indices performance in brain [18 F]FET-PET image segmentation using k-means.

PubMed

Abualhaj, Bedor; Weng, Guoyang; Ong, Melissa; Attarwala, Ali Asgar; Molina, Flavia; Büsing, Karen; Glatting, Gerhard

2017-01-01

Dynamic [ 18 F]fluoro-ethyl-L-tyrosine positron emission tomography ([ 18 F]FET-PET) is used to identify tumor lesions for radiotherapy treatment planning, to differentiate glioma recurrence from radiation necrosis and to classify gliomas grading. To segment different regions in the brain k-means cluster analysis can be used. The main disadvantage of k-means is that the number of clusters must be pre-defined. In this study, we therefore compared different cluster validity indices for automated and reproducible determination of the optimal number of clusters based on the dynamic PET data. The k-means algorithm was applied to dynamic [ 18 F]FET-PET images of 8 patients. Akaike information criterion (AIC), WB, I, modified Dunn's and Silhouette indices were compared on their ability to determine the optimal number of clusters based on requirements for an adequate cluster validity index. To check the reproducibility of k-means, the coefficients of variation CVs of the objective function values OFVs (sum of squared Euclidean distances within each cluster) were calculated using 100 random centroid initialization replications RCI 100 for 2 to 50 clusters. k-means was performed independently on three neighboring slices containing tumor for each patient to investigate the stability of the optimal number of clusters within them. To check the independence of the validity indices on the number of voxels, cluster analysis was applied after duplication of a slice selected from each patient. CVs of index values were calculated at the optimal number of clusters using RCI 100 to investigate the reproducibility of the validity indices. To check if the indices have a single extremum, visual inspection was performed on the replication with minimum OFV from RCI 100 . The maximum CV of OFVs was 2.7 × 10 -2 from all patients. The optimal number of clusters given by modified Dunn's and Silhouette indices was 2 or 3 leading to a very poor segmentation. WB and I indices suggested in

Temporal Stability and Convergent Validity of the Behavior Assessment System for Children.

ERIC Educational Resources Information Center

Merydith, Scott P.

2001-01-01

Assesses the temporal stability and convergent validity of the Behavioral Assessment System for Children (BASC). Teachers and parents rated kindergarten and first-grade students using BASC. Teachers were more stable in rating children's externalizing behaviors and attention problems. Discusses results in terms of the accuracy of information…

Mean Length of Utterance in Children with Specific Language Impairment and in Younger Control Children Shows Concurrent Validity and Stable and Parallel Growth Trajectories

ERIC Educational Resources Information Center

Rice, Mabel L.; Redmond, Sean M.; Hoffman, Lesa

2006-01-01

Purpose: Although mean length of utterance (MLU) is a useful benchmark in studies of children with specific language impairment (SLI), some empirical and interpretive issues are unresolved. The authors report on 2 studies examining, respectively, the concurrent validity and temporal stability of MLU equivalency between children with SLI and…

Muscle-specific colour stability of blesbok (Damaliscus pygargus phillipsi) meat.

PubMed

Neethling, Nikki E; Suman, Surendranath P; Sigge, Gunnar O; Hoffman, Louwrens C

2016-09-01

The increasing demand for meat from alternative species, such as blesbok (Damaliscus pygargus phillipsi), gives rise to the need for characterizing the quality attributes of fresh meat from these species. While muscle-specific colour stability has been extensively studied in conventional livestock, limited information is available on this phenomenon in game meat. Therefore, the objective of this study was to examine the colour stability of three major blesbok muscles, infraspinatus (IS), longissimus thoracis et lumborum (LTL) and biceps femoris (BF). Instrumental colour, surface myoglobin redox forms, and biochemical attributes influencing colour stability were measured on 2.5-cm steaks from blesbok IS, LTL, and BF during refrigerated storage under aerobic conditions for eight days. IS steaks consistently demonstrated higher (P≤0.05) redness, colour stability, and chroma than the LTL and BF steaks. These findings suggested that blesbok IS muscle is more colour-stable than its LTL and BF counterparts. The game industry may employ muscle-specific strategies to improve marketability of fresh blesbok meat. Copyright © 2016 Elsevier Ltd. All rights reserved.

The temporal stability and predictive validity of pupils' causal attributions for difficult classroom behaviour.

PubMed

Lambert, Nathan; Miller, Andy

2010-12-01

Recent studies have investigated the causal attributions for difficult pupil behaviour made by teachers, pupils, and parents but none have investigated the temporal stability or predictive validity of these attributions. This study examines the causal attributions made for difficult classroom behaviour by students on two occasions 30 months apart. The longitudinal stability of these attributions is considered as is the predictive validity of the first set of attributions in relation to teachers' later judgments about individual students' behaviour. Two hundred and seventeen secondary school age pupils (114 males, 103 females) provided data on the two occasions. Teachers also rated each student's behaviour at the two times. A questionnaire listing 63 possible causes of classroom misbehaviour was delivered to pupils firstly when they were in Year 7 (aged 11-12) and then again, 30 months later. Responses were analysed through exploratory factor analysis (EFA). Additionally, teachers were asked to rate the standard of behaviour of each of the students on the two occasions. EFA of the Years 7 and 10 data indicated that pupils' attributions yielded broadly similar five-factor models with the perceived relative importance of these factors remaining the same. Analysis also revealed a predictive relationship between pupils' attributions regarding the factor named culture of misbehaviour in Year 7, and teachers' judgments of their standard of behaviour in Year 10. The present study suggests that young adolescents' causal attributions for difficult classroom behaviour remain stable over time and are predictive of teachers' later judgments about their behaviour.

The stability of hydrogen ion and specific conductance in filtered wet-deposition samples stored at ambient temperatures

USGS Publications Warehouse

Gordon, J.D.; Schroder, L.J.; Morden-Moore, A. L.; Bowersox, V.C.

1995-01-01

Separate experiments by the U.S. Geological Survey (USGS) and the Illinois State Water Survey Central Analytical Laboratory (CAL) independently assessed the stability of hydrogen ion and specific conductance in filtered wet-deposition samples stored at ambient temperatures. The USGS experiment represented a test of sample stability under a diverse range of conditions, whereas the CAL experiment was a controlled test of sample stability. In the experiment by the USGS, a statistically significant (?? = 0.05) relation between [H+] and time was found for the composited filtered, natural, wet-deposition solution when all reported values are included in the analysis. However, if two outlying pH values most likely representing measurement error are excluded from the analysis, the change in [H+] over time was not statistically significant. In the experiment by the CAL, randomly selected samples were reanalyzed between July 1984 and February 1991. The original analysis and reanalysis pairs revealed that [H+] differences, although very small, were statistically different from zero, whereas specific-conductance differences were not. Nevertheless, the results of the CAL reanalysis project indicate there appears to be no consistent, chemically significant degradation in sample integrity with regard to [H+] and specific conductance while samples are stored at room temperature at the CAL. Based on the results of the CAL and USGS studies, short-term (45-60 day) stability of [H+] and specific conductance in natural filtered wet-deposition samples that are shipped and stored unchilled at ambient temperatures was satisfactory.

Stability Indices derived from Atmospheric Measurements on a Cable Car

NASA Astrophysics Data System (ADS)

Herma, F.; Seidel, J.; Bárdossy, A.

2012-04-01

Stability indices are meteorological parameters to describe vertical atmospheric layering and therefore it is possible to predict convective events such as thunderstorms. Commonly, weather balloons with radiosondes are used for the analysis of vertical atmospheric layering. These weather balloons reach high altitudes and atmospheric layering can be determined for the entire troposphere. On the other hand, these balloon ascents are expensive, require the appropriate equipment and permissions and cannot be conducted several times a day on an operational basis. Due to the limitations of the application of weather balloons the unconventional idea came up to equip a cable car with meteorological instruments for vertical profile measurements. To some extent the meteorological instruments had to be customized to the particular requirements and data are transmitted via GSM. The investigated area is a small alpine catchment which is prone to flash floods and thus a reliable forecast for such floods mostly caused by convective rainfall events is important. Therefore the purpose of this contribution is to proof if a cable car can be used for measuring continuous data during the operating hours and whether it is possible to derive reliable conclusions about the stability in the lower troposphere. Several stability indices (e.g. Lifted-, Showalter-, Boyden- and Convective-Index) were investigated. Indices which are calculated on the basis of the "Lifted Parcel Theory" were tested with different approaches to determine the most unstable parcel and therefore the initial values of the required parameters. The derived indices were flagged in active (thunderstorms) and non-active (no thunderstorms) cases. The classification results from available lightning maps in this region. Threshold values were established to distinguish stable, potential indifferent and unstable atmospheric conditions. On the basis of this division pre-warnings for the occurrence of thunderstorms are declared

A simple, rapid and stability indicating validated method for quantification of lamotrigine in human plasma and dry plasma spot using LC-ESI-MS/MS: Application in clinical study.

PubMed

Namdev, Kuldeep Kumar; Dwivedi, Jaya; Chilkoti, Deepak Chandra; Sharma, Swapnil

2018-01-01

Lamotrigine (LTZ) is a phenyltriazine derivative which belongs to anti-epileptic drugs (AEDs) class and prescribed as mono- or adjunctive-therapy in treatment of epilepsy. Therapeutic drug monitoring (TDM) of AEDs provides a valid clinical tool in optimization of overall therapy. However, TDM is challenging due to the high biological samples (plasma/blood) storage/shipment costs and the limited availability of laboratories providing TDM services. Sampling in the form of dry plasma spot (DPS) or dry blood spot (DBS) are suitable alternative to overcome these issues. We developed and validated a new method for quantification of LTZ in human plasma and DPS. The extraction of LTZ from plasma and DPS was performed using liquid-liquid extraction with diethyl ether and an extraction solution composed of diethyl ether- methyl tert-butyl ether- acetone (50:30:20, v/v/v), respectively. Lamotrigine- 13C3, d3 was used as internal standard (ISTD) and the chromatographic separation was achieved on Hypurity Advance C18 column (150×4.6mm, 5μm). Quantitative estimation of LTZ and ISTD was performed on a liquid chromatography tandem mass spectrometer coupled with electrospray ionization interface operated under positive mode of ionization. Calibration curves were linear (r 2 >0.99) over the concentration range of 10-3020ng/mL for both plasma and DPS. Statistical analysis provides insignificant difference between LTZ concentration extracted from plasma and DPS samples. The method is found suitable for application in clinical study and in therapeutic monitoring of LTZ. To the best of our knowledge this is the first report which describing a validated stability indicating assay for quantification of LTZ in dry plasma spot. Copyright © 2017 Elsevier B.V. All rights reserved.

Fractional Stability of Trunk Acceleration Dynamics of Daily-Life Walking: Toward a Unified Concept of Gait Stability

PubMed Central

Ihlen, Espen A. F.; van Schooten, Kimberley S.; Bruijn, Sjoerd M.; Pijnappels, Mirjam; van Dieën, Jaap H.

2017-01-01

Over the last decades, various measures have been introduced to assess stability during walking. All of these measures assume that gait stability may be equated with exponential stability, where dynamic stability is quantified by a Floquet multiplier or Lyapunov exponent. These specific constructs of dynamic stability assume that the gait dynamics are time independent and without phase transitions. In this case the temporal change in distance, d(t), between neighboring trajectories in state space is assumed to be an exponential function of time. However, results from walking models and empirical studies show that the assumptions of exponential stability break down in the vicinity of phase transitions that are present in each step cycle. Here we apply a general non-exponential construct of gait stability, called fractional stability, which can define dynamic stability in the presence of phase transitions. Fractional stability employs the fractional indices, α and β, of differential operator which allow modeling of singularities in d(t) that cannot be captured by exponential stability. The fractional stability provided an improved fit of d(t) compared to exponential stability when applied to trunk accelerations during daily-life walking in community-dwelling older adults. Moreover, using multivariate empirical mode decomposition surrogates, we found that the singularities in d(t), which were well modeled by fractional stability, are created by phase-dependent modulation of gait. The new construct of fractional stability may represent a physiologically more valid concept of stability in vicinity of phase transitions and may thus pave the way for a more unified concept of gait stability. PMID:28900400

Vertical jumping tests in volleyball: reliability, validity, and playing-position specifics.

PubMed

Sattler, Tine; Sekulic, Damir; Hadzic, Vedran; Uljevic, Ognjen; Dervisevic, Edvin

2012-06-01

Vertical jumping is known to be important in volleyball, and jumping performance tests are frequently studied for their reliability and validity. However, most studies concerning jumping in volleyball have dealt with standard rather than sport-specific jumping procedures and tests. The aims of this study, therefore, were (a) to determine the reliability and factorial validity of 2 volleyball-specific jumping tests, the block jump (BJ) test and the attack jump (AJ) test, relative to 2 frequently used and systematically validated jumping tests, the countermovement jump test and the squat jump test and (b) to establish volleyball position-specific differences in the jumping tests and simple anthropometric indices (body height [BH], body weight, and body mass index [BMI]). The BJ was performed from a defensive volleyball position, with the hands positioned in front of the chest. During an AJ, the players used a 2- to 3-step approach and performed a drop jump with an arm swing followed by a quick vertical jump. A total of 95 high-level volleyball players (all men) participated in this study. The reliability of the jumping tests ranged from 0.97 to 0.99 for Cronbach's alpha coefficients, from 0.93 to 0.97 for interitem correlation coefficients and from 2.1 to 2.8 for coefficients of variation. The highest reliability was found for the specific jumping tests. The factor analysis extracted one significant component, and all of the tests were highly intercorrelated. The analysis of variance with post hoc analysis showed significant differences between 5 playing positions in some of the jumping tests. In general, receivers had a greater jumping capacity, followed by libero players. The differences in jumping capacities should be emphasized vis-a-vis differences in the anthropometric measures of players, where middle hitters had higher BH and body weight, followed by opposite hitters and receivers, with no differences in the BMI between positions.

Protein Stabilization and Enzyme Activation in Ionic Liquids: Specific Ion Effects

PubMed Central

Zhao, Hua

2015-01-01

There are still debates on whether the hydration of ions perturbs the water structure, and what is the degree of such disturbance; therefore, the origin of Hofmeister effect on protein stabilization continues being questioned. For this reason, it is suggested to use the ‘specific ion effect’ instead of other misleading terms such as Hofmeister effect, Hofmeister series, lyotropic effect, and lyotropic series. In this review, we firstly discuss the controversial aspect of inorganic ion effects on water structures, and several possible contributors to the specific ion effect of protein stability. Due to recent overwhelming attraction of ionic liquids (ILs) as benign solvents in many enzymatic reactions, we further evaluate the structural properties and molecular-level interactions in neat ILs and their aqueous solutions. Next, we systematically compare the specific ion effects of ILs on enzyme stability and activity, and conclude that (a) the specificity of many enzymatic systems in diluted aqueous IL solutions is roughly in line with the traditional Hofmeister series albeit some exceptions; (b) however, the specificity follows a different track in concentrated or neat ILs because other factors (such as hydrogen-bond basicity, nucelophilicity, and hydrophobicity, etc) are playing leading roles. In addition, we demonstrate some examples of biocatalytic reactions in IL systems that are guided by the empirical specificity rule. PMID:26949281

Assessing Temporal Stability for Coarse Scale Satellite Moisture Validation in the Maqu Area, Tibet

PubMed Central

Bhatti, Haris Akram; Rientjes, Tom; Verhoef, Wouter; Yaseen, Muhammad

2013-01-01

This study evaluates if the temporal stability concept is applicable to a time series of satellite soil moisture images so to extend the common procedure of satellite image validation. The area of study is the Maqu area, which is located in the northeastern part of the Tibetan plateau. The network serves validation purposes of coarse scale (25–50 km) satellite soil moisture products and comprises 20 stations with probes installed at depths of 5, 10, 20, 40, 80 cm. The study period is 2009. The temporal stability concept is applied to all five depths of the soil moisture measuring network and to a time series of satellite-based moisture products from the Advance Microwave Scanning Radiometer (AMSR-E). The in-situ network is also assessed by Pearsons's correlation analysis. Assessments by the temporal stability concept proved to be useful and results suggest that probe measurements at 10 cm depth best match to the satellite observations. The Mean Relative Difference plot for satellite pixels shows that a RMSM pixel can be identified but in our case this pixel does not overlay any in-situ station. Also, the RMSM pixel does not overlay any of the Representative Mean Soil Moisture (RMSM) stations of the five probe depths. Pearson's correlation analysis on in-situ measurements suggests that moisture patterns over time are more persistent than over space. Since this study presents first results on the application of the temporal stability concept to a series of satellite images, we recommend further tests to become more conclusive on effectiveness to broaden the procedure of satellite validation. PMID:23959237

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.

The Riso-Hudson Enneagram Type Indicator: Estimates of Reliability and Validity

ERIC Educational Resources Information Center

Newgent, Rebecca A.; Parr, Patricia E.; Newman, Isadore; Higgins, Kristin K.

2004-01-01

This investigation was conducted to estimate the reliability and validity of scores on the Riso-Hudson Enneagram Type Indicator (D. R. Riso & R. Hudson, 1999a). Results of 287 participants were analyzed. Alpha suggests an adequate degree of internal consistency. Evidence provides mixed support for construct validity using correlational and…

The HSE Management Standards Indicator Tool: concurrent and construct validity.

PubMed

Marcatto, F; Colautti, L; Larese Filon, F; Luis, O; Ferrante, D

2014-07-01

The Health & Safety Executive Management Standards Indicator Tool (HSE-MS IT) is a questionnaire commonly used to assess work-related stress risks at an organizational level. A critical factor in determining whether this instrument is actually useful is that higher levels of stress risk in the work-design domains should predict higher levels of stress and stress-related outcomes in workers. Only a few studies, however, have addressed this issue. To test both the concurrent and construct validity of the HSE-MS IT, by relating it with another widely used instrument, the Job Content Questionnaire (JCQ), and by examining its relationships with a set of work-related stress outcomes. An anonymous cross-sectional questionnaire was administered to a sample of employees in an Italian municipality. The questionnaire included the HSE-MS IT, self-reported measures of job satisfaction, job motivation and stress at work, the Satisfaction with Life Scale and the reduced form of the JCQ. A total of 760 out of 779 employees completed the questionnaire. Results showed moderate to strong correlation among the corresponding HSE-MS IT and JCQ scales. Hierarchical regression highlighted the specific contribution of each of the HSE-MS IT scales in predicting three relevant work-related stress outcomes (self-reported stress, job satisfaction and job motivation), after controlling for gender, age and life satisfaction. Our findings consolidated the HSE-MS IT validity and showed the specific sensitivity of its scales to assess different aspects of work-related distress, including self-perception of stress at work. These results can have practical implications for the occupational well-being of employees. © The Author 2014. Published by Oxford University Press on behalf of the Society of Occupational Medicine. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Optimal placement of unified power flow controllers to improve dynamic voltage stability using power system variable based voltage stability indices.

PubMed

Albatsh, Fadi M; Ahmad, Shameem; Mekhilef, Saad; Mokhlis, Hazlie; Hassan, M A

2015-01-01

This study examines a new approach to selecting the locations of unified power flow controllers (UPFCs) in power system networks based on a dynamic analysis of voltage stability. Power system voltage stability indices (VSIs) including the line stability index (LQP), the voltage collapse proximity indicator (VCPI), and the line stability index (Lmn) are employed to identify the most suitable locations in the system for UPFCs. In this study, the locations of the UPFCs are identified by dynamically varying the loads across all of the load buses to represent actual power system conditions. Simulations were conducted in a power system computer-aided design (PSCAD) software using the IEEE 14-bus and 39- bus benchmark power system models. The simulation results demonstrate the effectiveness of the proposed method. When the UPFCs are placed in the locations obtained with the new approach, the voltage stability improves. A comparison of the steady-state VSIs resulting from the UPFCs placed in the locations obtained with the new approach and with particle swarm optimization (PSO) and differential evolution (DE), which are static methods, is presented. In all cases, the UPFC locations given by the proposed approach result in better voltage stability than those obtained with the other approaches.

Optimal Placement of Unified Power Flow Controllers to Improve Dynamic Voltage Stability Using Power System Variable Based Voltage Stability Indices

PubMed Central

Albatsh, Fadi M.; Ahmad, Shameem; Mekhilef, Saad; Mokhlis, Hazlie; Hassan, M. A.

2015-01-01

This study examines a new approach to selecting the locations of unified power flow controllers (UPFCs) in power system networks based on a dynamic analysis of voltage stability. Power system voltage stability indices (VSIs) including the line stability index (LQP), the voltage collapse proximity indicator (VCPI), and the line stability index (Lmn) are employed to identify the most suitable locations in the system for UPFCs. In this study, the locations of the UPFCs are identified by dynamically varying the loads across all of the load buses to represent actual power system conditions. Simulations were conducted in a power system computer-aided design (PSCAD) software using the IEEE 14-bus and 39- bus benchmark power system models. The simulation results demonstrate the effectiveness of the proposed method. When the UPFCs are placed in the locations obtained with the new approach, the voltage stability improves. A comparison of the steady-state VSIs resulting from the UPFCs placed in the locations obtained with the new approach and with particle swarm optimization (PSO) and differential evolution (DE), which are static methods, is presented. In all cases, the UPFC locations given by the proposed approach result in better voltage stability than those obtained with the other approaches. PMID:25874560

A method to determine residue-specific unfolded-state pKa values from analysis of stability changes in single mutant cycles.

PubMed

Shen, Jana K

2010-06-02

It is now widely recognized that the unfolded state of a protein in equilibrium with the native state under folding conditions may contain significant residual structures. However, due to technical difficulties residue-specific interactions in the unfolded state remain elusive. Here we introduce a method derived from the Wyman-Tanford theory to determine residue-specific pK(a)'s in the unfolded state. This method requires equilibrium stability measurements of the wild type and single-point mutants in which titrable residues are replaced with charge-neutral ones under two pH conditions. Application of the proposed approach reveals a highly depressed pK(a) for Asp8 in the unfolded state of the NTL9 protein. Knowledge of unfolded-state pK(a)'s enables quantitative estimation of the unfolded-state electrostatic effects on protein stability. It also provides valuable benchmarks for the improvement of force fields and validation of microscopic information from molecular dynamics simulations.

The validity, stability, and utility of measuring uric acid in saliva.

PubMed

Riis, Jenna L; Bryce, Crystal I; Matin, Marla J; Stebbins, John L; Kornienko, Olga; Huisstede, Lauren van; Granger, Douglas A

2018-06-06

Serum uric acid (UA) is associated with many health conditions, including kidney, cardiovascular, and metabolic disorders. We examined the validity and stability of salivary UA as a noninvasive measure of serum UA. Using serum and salivary UA data from healthy adults (n = 99), we examined the UA serum-saliva correlation, and UA associations with adiponectin and C-reactive protein. Using longitudinal data from young adults (n = 182), we examined salivary UA stability. We found robust positive serum-saliva correlations for UA. UA and adiponectin were inversely related in serum and saliva. Salivary UA was relatively stable; 62-66% of variance could be attributed to a latent trait-like component. Salivary UA may be an important biomarker indexing health and disease risk.

Improvement of stability of Nb 3 Sn superconductors by introducing high specific heat substances

DOE PAGES

Xu, X.; Li, P.; Zlobin, A. V.; ...

2018-01-24

High-J c Nb 3Sn conductors have low stability against perturbations, which accounts for the slow training rates of high-field Nb 3Sn magnets. While it is known that adding substances with high specific heat (C) into Nb 3Sn wires can increase their overall specific heat and thus improve their stability, there has not been a practical method that is compatible with the fabrication of long-length conductors. In this work, we put forward a scheme to introduce such substances to distributed-barrier Nb 3Sn wires, which adds minimum difficulty to the wire manufacturing process. Multifilamentary wires using a mixture of Cu and high-Cmore » Gd 2O 3 powders have been successfully fabricated along this line. Measurements showed that addition of Gd 2O 3 had no negative effects on residual resitivity ratio or non-Cu J c, and that flux jumps were remarkably reduced, and minimum quench energy values at 4.2 K, 14 T were increased by a factor of three, indicating that stability was significantly improved. We also discussed the influences of the positioning of high-C substances and their thermal diffusivity on their effectiveness in reducing the superconductor temperature rise against perturbations. Based on these results, we proposed an optimized conductor architecture to maximize the effectiveness of this approach.« less

Improvement of stability of Nb 3 Sn superconductors by introducing high specific heat substances

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

Xu, X.; Li, P.; Zlobin, A. V.

High-J c Nb 3Sn conductors have low stability against perturbations, which accounts for the slow training rates of high-field Nb 3Sn magnets. While it is known that adding substances with high specific heat (C) into Nb 3Sn wires can increase their overall specific heat and thus improve their stability, there has not been a practical method that is compatible with the fabrication of long-length conductors. In this work, we put forward a scheme to introduce such substances to distributed-barrier Nb 3Sn wires, which adds minimum difficulty to the wire manufacturing process. Multifilamentary wires using a mixture of Cu and high-Cmore » Gd 2O 3 powders have been successfully fabricated along this line. Measurements showed that addition of Gd 2O 3 had no negative effects on residual resitivity ratio or non-Cu J c, and that flux jumps were remarkably reduced, and minimum quench energy values at 4.2 K, 14 T were increased by a factor of three, indicating that stability was significantly improved. We also discussed the influences of the positioning of high-C substances and their thermal diffusivity on their effectiveness in reducing the superconductor temperature rise against perturbations. Based on these results, we proposed an optimized conductor architecture to maximize the effectiveness of this approach.« less

Subtle alternating electrocardiographic morphology as an indicator of decreased cardiac electrical stability

NASA Technical Reports Server (NTRS)

Smith, J. M.; Blue, B.; Clancy, E.; Valeri, C. R.; Cohen, R. J.

1985-01-01

Observations from finite-element computer models, together with analytic developments based on percolation theory have suggested that subtle fluctuations of ECG morphology might serve as an indicator diminished cardiac electrical stability. With fixed-rate atrial pacing in canines, we have previously observed a pattern of alternation in T wave energy which correlated with cardiac electrical stability. We report here on a series of 20 canine experiments in which cardiac electrical stability (measured via Ventricular Fibrillation Threshold determination) was compared to a non-degenerate, multidimensional measurement of the degree of alternating activity present in the ECG complex morphology. The decrease in cardiac electrical stability brought on by both coronary artery occlusion and systemic hypothermia was consistently accompanied by subtle alternation in ECG morphology, with the absolute degree of alternating activity being significantly (negatively) correlated with cardiac electrical stability.

Stability of physical activity, fitness components and diet quality indices.

PubMed

Mertens, E; Clarys, P; Mullie, P; Lefevre, J; Charlier, R; Knaeps, S; Huybrechts, I; Deforche, B

2017-04-01

Regular physical activity (PA), a high level of fitness and a high diet quality are positively associated with health. However, information about stability of fitness components and diet quality indices is limited. This study aimed to evaluate stability of those parameters. This study includes 652 adults (men=57.56 (10.28) years; women=55.90 (8.34) years at follow-up) who participated in 2002-2004 and returned for follow-up at the Policy Research Centre Leuven in 2012-2014. Minutes sport per day and Physical activity level (PAL) were calculated from the Flemish Physical Activity Computerized Questionnaire. Cardiorespiratory fitness (CRF), morphological fitness (MORF; body mass index and waist circumference) and metabolic fitness (METF) (blood cholesterol and triglycerides) were used as fitness components. Diet quality indices (Healthy Eating Index-2010 (HEI), Diet Quality Index (DQI), Mediterranean Diet Score (MDS)) were calculated from a diet record. Tracking coefficients were calculated using Pearson/Spearman correlation coefficients (r Pearson ) and intra-class correlation coefficients (r ICC ). In both men (r Pearson&ICC =0.51) and women (r Pearson =0.62 and r ICC =0.60) PAL showed good stability, while minutes sport remained stable in women (r Pearson&ICC =0.57) but less in men (r Pearson&ICC =0.45). Most fitness components remained stable (r⩾0.50) except some METF components in women. In general the diet quality indices and their components were unstable (r<0.50). PAL and the majority of the fitness components remained stable, while diet quality was unstable over 10 years. For unstable parameters such as diet quality measurements are needed at both time points in prospective research.

Specific anions effects of on the stability of azurin in ice.

PubMed

Strambini, Giovanni B; Gonnelli, Margherita

2008-08-21

This investigation represents a first attempt to gain a quantitative estimate of the effects of the anions sulfate, citrate, acetate, chloride and thiocyanate on the thermodynamic stability (DeltaG degrees) of a model globular protein in ice at -15 degrees C. The method, based on guanidinium chloride denaturation of the azurin mutant C112S from Pseudomonas aeruginosa, distinguishes between the effects of cooling to subfreezing temperatures from those induced specifically by the formation of a solid ice phase. The results confirm that, both in liquid and frozen states, kosmotropes (sulfate, citrate and acetate) increase significantly protein stability, relative to chloride, whereas the chaotrope thiocyanate decreases it. Throughout, their stabilizing efficacy was found to rank according to the Hofmeister series, sulfate>citrate>acetate>chloride>thiocyanate, although the magnitude of Delta(DeltaG degrees) exhibited a distinct sensitivity among the anions to low temperature and to ice formation. In the liquid state, lowering the temperature from +20 to -15 degreesC weakens considerably the stabilizing efficacy of the organic anions citrate and acetate. Among the anions sulfate stands out as the only strong stabilizer at subfreezing temperatures while SCN- becomes an even stronger denaturant. Freezing of the solution in the presence the "neutral" salt NaCl destabilizes the protein, DeltaG degrees progressively decreasing up to 3-4 kcal/mol as the fraction of liquid water in equilibrium with ice (VL) is reduced to less than 1%. Kosmotropes do attenuate the decrease in protein stability in ice although in the case of citrate and acetate, their efficacy diminishes sharply as the liquid fraction shrinks to below 2.7%. On the contrary, sulfate is remarkable for it maintains constantly high the stability of azurin in liquid and frozen solutions, down to the smallest VL (0.5%) examined. Throughout, the reduction in DeltaG degrees caused by the solidification of water

Improvement of a stability-indicating method by Quality-by-Design versus Quality-by-Testing: a case of a learning process.

PubMed

Hubert, C; Lebrun, P; Houari, S; Ziemons, E; Rozet, E; Hubert, Ph

2014-01-01

The understanding of the method is a major concern when developing a stability-indicating method and even more so when dealing with impurity assays from complex matrices. In the presented case study, a Quality-by-Design approach was applied in order to optimize a routinely used method. An analytical issue occurring at the last stage of a long-term stability study involving unexpected impurities perturbing the monitoring of characterized impurities needed to be resolved. A compliant Quality-by-Design (QbD) methodology based on a Design of Experiments (DoE) approach was evaluated within the framework of a Liquid Chromatography (LC) method. This approach allows the investigation of Critical Process Parameters (CPPs), which have an impact on Critical Quality Attributes (CQAs) and, consequently, on LC selectivity. Using polynomial regression response modeling as well as Monte Carlo simulations for error propagation, Design Space (DS) was computed in order to determine robust working conditions for the developed stability-indicating method. This QbD compliant development was conducted in two phases allowing the use of the Design Space knowledge acquired during the first phase to define the experimental domain of the second phase, which constitutes a learning process. The selected working condition was then fully validated using accuracy profiles based on statistical tolerance intervals in order to evaluate the reliability of the results generated by this LC/ESI-MS stability-indicating method. A comparison was made between the traditional Quality-by-Testing (QbT) approach and the QbD strategy, highlighting the benefit of this QbD strategy in the case of an unexpected impurities issue. On this basis, the advantages of a systematic use of the QbD methodology were discussed. Copyright © 2013 Elsevier B.V. All rights reserved.

Robustness of hydrological indicators for transient and stabilized climate states

NASA Astrophysics Data System (ADS)

Boulange, J. E.; Hanasaki, N.

2017-12-01

By signing the Paris agreement, countries have committed to pursue efforts to limit global warming to +1.5 °C relative to pre-industrial levels. Consequently, there is a growing interest in better understanding the impacts of a +1.5°C world. Previous analyses were conducted by considering a time slice period, centered on the year when the global mean temperature (GMT) crosses the +1.5°C threshold (Fig. 1). This time slice period is characterized by a transient state which may influence the reported results (transient climate state). Ideally, analyses should be carried under the condition the GMT is stabilized at +1.5°C (stabilized climate state) but, such targeted simulations do not exist for most GCMs.1A global hydrological model, the H08 model,2 and hydrological indicators (HI) obtained for the transient and stabilized states, are used to answer the following questions: (1) are there quantifiable differences between the HI computed for the transient and stabilized states? (2) can relations be derived between the HI computed for the transient and stabilized states? (3) what are the potential impacts induced by the differences in HI computed for the transient and stabilized states? Signal to noise ratios (S/N) obtained for the transient and stabilized states, in an identical warmer world (+1.7°C), are compared (Fig. 2). The S/N ratio computed for the stabilized state were significantly lower than those of the transient state for most regions and HI. However, at higher latitude, the S/N ratios computed for the two states were similar whereas for medium and low latitudes, the differences were more pronounced. For most regions and HI (except for surface temperature), the S/N ratios of the stabilized state were 10 to 20% weaker than those of the transient state. References:1 Knutti, R., Rogelj, J., Sedlacek, J. & Fischer, E. M. Nature Geosci (2016). 2 Hanasaki, N. et al. Hydrol. Earth Syst. Sci. (2008).

Measuring sperm whales from their clicks: Stability of interpulse intervals and validation that they indicate whale length

NASA Astrophysics Data System (ADS)

Rhinelander, Marcus Q.; Dawson, Stephen M.

2004-04-01

Multiple pulses can often be distinguished in the clicks of sperm whales (Physeter macrocephalus). Norris and Harvey [in Animal Orientation and Navigation, NASA SP-262 (1972), pp. 397-417] proposed that this results from reflections within the head, and thus that interpulse interval (IPI) is an indicator of head length, and by extrapolation, total length. For this idea to hold, IPIs must be stable within individuals, but differ systematically among individuals of different size. IPI stability was examined in photographically identified individuals recorded repeatedly over different dives, days, and years. IPI variation among dives in a single day and days in a single year was statistically significant, although small in magnitude (it would change total length estimates by <3%). As expected, IPIs varied significantly among individuals. Most individuals showed significant increases in IPIs over several years, suggesting growth. Mean total lengths calculated from published IPI regressions were 13.1 to 16.1 m, longer than photogrammetric estimates of the same whales (12.3 to 15.3 m). These discrepancies probably arise from the paucity of large (12-16 m) whales in data used in published regressions. A new regression is offered for this size range.

Laboratory sample stability. Is it possible to define a consensus stability function? An example of five blood magnitudes.

PubMed

Gómez Rioja, Rubén; Martínez Espartosa, Débora; Segovia, Marta; Ibarz, Mercedes; Llopis, María Antonia; Bauça, Josep Miquel; Marzana, Itziar; Barba, Nuria; Ventura, Monserrat; García Del Pino, Isabel; Puente, Juan José; Caballero, Andrea; Gómez, Carolina; García Álvarez, Ana; Alsina, María Jesús; Álvarez, Virtudes

2018-05-05

The stability limit of an analyte in a biological sample can be defined as the time required until a measured property acquires a bias higher than a defined specification. Many studies assessing stability and presenting recommendations of stability limits are available, but differences among them are frequent. The aim of this study was to classify and to grade a set of bibliographic studies on the stability of five common blood measurands and subsequently generate a consensus stability function. First, a bibliographic search was made for stability studies for five analytes in blood: alanine aminotransferase (ALT), glucose, phosphorus, potassium and prostate specific antigen (PSA). The quality of every study was evaluated using an in-house grading tool. Second, the different conditions of stability were uniformly defined and the percent deviation (PD%) over time for each analyte and condition were scattered while unifying studies with similar conditions. From the 37 articles considered as valid, up to 130 experiments were evaluated and 629 PD% data were included (106 for ALT, 180 for glucose, 113 for phosphorus, 145 for potassium and 85 for PSA). Consensus stability equations were established for glucose, potassium, phosphorus and PSA, but not for ALT. Time is the main variable affecting stability in medical laboratory samples. Bibliographic studies differ in recommedations of stability limits mainly because of different specifications for maximum allowable error. Definition of a consensus stability function in specific conditions can help laboratories define stability limits using their own quality specifications.

Bioremediation of Contaminated Lake Sediments and Evaluation of Maturity Indicies as Indicators of Compost Stability

PubMed Central

Rekha, P.; Suman Raj, D. S.; Aparna, C.; Bindu, V. Hima; Anjaneyulu, Y.

2005-01-01

Land contamination is one of the widely addressed problems, which is gaining importance in many developed and developing countries. International efforts are actively envisaged to remediate contaminated sites as a response to adverse health effects. Popular conventional methodologies only transfer the phase of the contaminant involving cost intensive liabilities besides handling risk of the hazardous waste. Physico-chemical methods are effective for specific wastes, but are technically complex and lack public acceptance for land remediation. “Bioremediation”, is one of the emerging low-cost technologies that offer the possibility to destroy various contaminants using natural biological activities. Resultant non -toxic end products due to the microbial activity and insitu applicability of this technology is gaining huge public acceptance. In the present study, composting is demonstrated as a bioremediation methodology for the stabilization of contaminated lake sediments of Hyderabad, A.P, India. Lake sediment contaminated with organics is collected from two stratums – upper (0.25 m) and lower (0.5m) to set up as Pile I (Upper) and Pile II (Lower) in the laboratory. Lime as a pretreatment to the lake sediments is carried out to ensure metal precipitation. The pretreated sediment is then mixed with organic and inorganic fertilizers like cow dung, poultry manure, urea and super phosphate as initial seeding amendments. Bulking agents like sawdust and other micronutrients are provided. Continuous monitoring of process control parameters like pH, moisture content, electrical conductivity, total volatile solids and various forms of nitrogen were carried out during the entire course of the study. The stability of the compost was evaluated by assessing maturity indices like C/N, Cw (water soluble carbon), CNw (Cw/Nw), nitrification index (NH4/NO−3), Cation Exchange Capacity (CEC), germination index, humification ratio, compost mineralization index (ash content

Measuring progress in maternal and newborn health care in Mexico: validating indicators of health system contact and quality of care.

PubMed

Blanc, Ann K; Diaz, Claudia; McCarthy, Katharine J; Berdichevsky, Karla

2016-08-30

The majority of births in Mexico take place in a health facility and are attended by a skilled birth attendant, yet maternal mortality has not declined to anticipated levels. Coverage estimates of skilled attendance and other maternal and newborn interventions often rely on women's self-report through a population-based survey, the accuracy of which is not well established. We used a facility-based design to validate women's report of skilled birth attendance, as well as other key elements of maternal, newborn intrapartum, and immediate postnatal care. Women's reports of labor and delivery care were collected by exit interview prior to hospital discharge and were compared against direct observation by a trained third party in a Mexican public hospital (n = 597). For each indicator, validity was assessed at the individual level using the area under the receiver operating curve (AUC) and at the population level using the inflation factor (IF). Five of 47 indicators met both validation criteria (AUC > 0.60 and 0.75 < IF < 1.25): urine sample screen, injection or IV medication received during labor, before the birth of the baby (i.e., uterotonic for either induction or augmentation of labor), episiotomy, excessive bleeding, and receipt of blood products. An additional 9 indicators met criteria for the AUC and 18 met criteria for the IF. A skilled attendant indicator had high sensitivity (90.1 %: 95 % CI: 87.1-92.5 %), low specificity (14.0 %: 95 % CI: 5.8-26.7 %) and was suitable for population-level estimation only. Women are able to give valid reports on some aspects of the content of care, although questions regarding the indication for interventions are less likely to be known. Questions that include technical terms or refer to specific time periods tended to have lower response levels. A key aspect of efforts to improve maternal and newborn health requires valid measurement of women's access to maternal and newborn health interventions and

Psychometric validation of the PROQOL-HIV questionnaire, a new health-related quality of life instrument-specific to HIV disease.

PubMed

Duracinsky, Martin; Lalanne, Christophe; Le Coeur, Sophie; Herrmann, Susan; Berzins, Baiba; Armstrong, Andrew Richard; Lau, Joseph Tak Fai; Fournier, Isabelle; Chassany, Olivier

2012-04-15

This study reports the psychometric validation of a new HIV/AIDS-specific health-related quality of life (HRQL) questionnaire, the Patient Reported Outcomes Quality of Life-HIV. The instrument was developed simultaneously across Europe, North and South America, Africa, Asia, and Australia to assess multidimensional quality of life impairments in the era of highly active antiretroviral therapy. A cross-sectional study was performed in 8 countries. The pilot 70-item questionnaire was co-administered with the HIV symptoms index, the EQ-5D and Medical Outcomes Study-HIV questionnaires. Demographic and biomedical data were collected. After item analysis and reduction, convergent discriminant concurrent validity and known-group validity were examined. Internal consistency and reliability scores were assessed using Cronbach alpha and intraclass correlation. The final sample of 791 patients was composed of 64% males (median age: 41 years, HIV diagnosis = 5 years), 13.8% were treatment naive. Item reduction yielded a 43-item form surveying 8 dimensions and 1 global health item that showed good convergent and discriminant validity and reliability (98% scaling success; Cronbach alphas 0.77-0.89). Correlations with EQ-5D and Medical Outcomes Study-HIV complied with concurrent validity expectations; likewise, correlations against the number of self-reported symptoms and depression showed good support for criterion validity. A test-retest study on French patients (n = 34) showed temporal stability (intraclass correlation coefficient = 0.86). Significant and meaningful differences of HRQL scores between countries were found. The Patient Reported Outcomes Quality of Life-HIV questionnaire is a valid and reliable instrument for assessing HRQL specific to HIV disease in different cultures and healthcare systems.

Development and Validation of the Career Competencies Indicator (CCI)

ERIC Educational Resources Information Center

Francis-Smythe, Jan; Haase, Sandra; Thomas, Erica; Steele, Catherine

2013-01-01

This article describes the development and validation of the Career Competencies Indicator (CCI); a 43-item measure to assess career competencies (CCs). Following an extensive literature review, a comprehensive item generation process involving consultation with subject matter experts, a pilot study and a factor analytic study on a large sample…

Efficacy validation of synthesized retinol derivatives In vitro: stability, toxicity, and activity.

PubMed

Han, Hye-Sook; Kwon, Youn-Ja; Park, Myoung-Soon; Park, Si-Ho; Cho, So-Mi Kim; Rho, Young-Soy; Kim, Jin-Wou; Sin, Hong-Sig; Um, Soo-Jong

2003-08-15

Retinol (vitamin A) is used as an antiwrinkle agent in the cosmetics industry. However, its photo-instability makes it unsuitable for use in general cosmetic formulations. To improve the photo-stability of retinol, three derivatives (3, 4, and 5) were synthesized and their biological activities were analyzed. 1H NMR and HPLC analysis indicated that derivatives 3 and 5 were much more stable than retinol under our sunlight exposure conditions. When human adult fibroblasts were treated, the IC(50) of derivative 3 was 96 microM, which is similar to that of retinol, as determined by the MTT assay. Derivatives 4 and 5 were 2.5 and 8 times more toxic than retinol, respectively. At 1 microM treatment, like retinol, derivatives 3 and 4 were specifically active for RARalpha out of six retinoid receptors (RAR/RXRalpha, beta, gamma). Dose-dependent analysis confirmed that derivative 4 was as active as retinol and the other two derivatives were less active for RARalpha. The effect of our derivatives on the expression of collagenase, an indicator of wrinkle formation, was measured using the transient co-expression of c-Jun and RT-PCR in HaCaT cells. Collagenase promoter activity, which is increased by c-Jun expression, was reduced 42% by retinol treatment. The other derivatives inhibited collagenase promoter activity similarly. These results were further confirmed by RT-PCR analysis of the collagenase gene. Taken together, our results suggest that retinol derivative 3 is a promising antiwrinkle agent based on its higher photo-stability, lower RARalpha activity (possibly indicating reduced side effects), and similar effect on collagenase expression.

Spanish validation of the Domain-Specific Risk-Taking (DOSPERT-30) Scale.

PubMed

Lozano, Luis M; Megías, Alberto; Catena, Andrés; Perales, José C; Baltruschat, Sabina; Cándido, Antonio

2017-02-01

The aim of the present study was to develop and validate a Spanish version of the short Domain-Specific Risk-Taking (DOSPERT-30) scale, measuring risk-taking behavior, risk perception, and expected beneficial consequences (from taking risks) in five life domains: ethics, finance, health/security, recreational, and social decisions. The scale was back-translated, and administered online to 826 participants. Validity evidence was tested using correlations with construct-related instruments (UPPS-P and SSS-V), as well as using factor analysis. Internal consistency reliability was calculated with the ordinal Alpha coefficient, and gender differences were considered. Internal consistency was good, and factor analysis confirmed the five factors proposed by the authors. With respect to the external validity, high correlations with the positive urgency and the sensation seeking subscales of the UPPS-P, as well as with the thrill and adventure seeking and disinhibition subscales of the SSS-V were found. Finally, gender differences were found in all subscales and domains, with men tending to take more risks, perceive less risk and expect more beneficial consequences, except for the social domain where an inverse pattern was found. As these findings are in line with the original version, they indicate the scale was successfully adapted.

Initial Validation of an Instrument Measuring Psychology-Specific Epistemological Beliefs

ERIC Educational Resources Information Center

Renken, Maggie D.; McMahan, Ethan A.; Nitkova, Martina

2015-01-01

Psychology-specific epistemological beliefs (EBs) are believed to influence students' approach to and performance in psychology courses. However, empirical research on this topic is limited due in part to a lack of well-validated instruments measuring this construct. The primary objective of this research was to develop and validate the…

Comparative Assessment of the Effect of Hyper-glycosylation on the Pattern and Kinetics of Degradation of Darbepoetin Alfa using a Stability-Indicating Orthogonal Testing Protocol.

PubMed

Moenes, Eman M; Al-Ghobashy, Medhat A; Mohamed, Abeer A; Salem, Maissa Y

2018-01-01

Darbepoetin alfa (DA); hyper-glycosylated Erythropoietin alfa (EPO) is an essential treatment of anemia in patients with chronic kidney failure and cancer. In this study, DA and EPO were subjected to physicochemical stress factors that might be encountered during production, transport and storage (pH, temperature, agitation, repeated freeze-thaw and oxidation). An orthogonal stability-indicating assay protocol comprised of SE-HPLC, RP-HPLC, ELISA and SDS-PAGE was developed and validated to investigate the effect of further glycosylation of DA on the pattern and kinetics of degradation. Results showed a relatively higher stability and lower tendency to form high molecular weight aggregates in the case of DA when compared to EPO, under equivalent stress conditions. Dimers and aggregates were formed for both drugs across the whole pH range and following incubation at temperatures higher than 2-8°C or repeated freeze/thaw. The same observation was noted upon agitation of standard samples prepared in the formulation buffers at high speed and upon oxidation with hydrogen peroxide. The agreement between SE-HPLC, supported with spectral purity data and ELISA confirmed the specificity of both techniques for the intact drugs. Results of RP-HPLC and SDS-PAGE indicated that dimerization occurred through disulfide and bi-tyrosine covalent bonds in the case of pH and oxidation, respectively. It was evident that aggregation was significantly suppressed upon increasing the glycan size and under any of the studied stress factors loss of the glycan has not been observed. These observations supported with the slow kinetics of degradation confirmed the superiority of glyco-engineering over chemical pegylation to enhance the stability of EPO. Formation of such potentially immunogenic product-related impurities at all tested stress factors confirmed the need for orthogonal testing protocols to investigate the complex pattern of degradation of such sensitive products. Copyright © 2017

The Predictive Validity of CBM Writing Indices for Eighth-Grade Students

ERIC Educational Resources Information Center

Amato, Janelle M.; Watkins, Marley W.

2011-01-01

Curriculum-based measurement (CBM) is an alternative to traditional assessment techniques. Technical work has begun to identify CBM writing indices that are psychometrically sound for monitoring older students' writing proficiency. This study examined the predictive validity of CBM writing indices in a sample of 447 eighth-grade students.…

Nursing Intensive-Care Satisfaction Scale [NICSS]: Development and validation of a patient-centred instrument.

PubMed

Romero-García, Marta; de la Cueva-Ariza, Laura; Benito-Aracil, Llucia; Lluch-Canut, Teresa; Trujols-Albet, Joan; Martínez-Momblan, Maria Antonia; Juvé-Udina, Maria-Eulàlia; Delgado-Hito, Pilar

2018-06-01

The aim of this study was to develop and validate the Nursing Intensive-Care Satisfaction Scale to measures satisfaction with nursing care from the critical care patient's perspective. Instruments that measure satisfaction with nursing cares have been designed and validated without taking the patient's perspective into consideration. Despite the benefits and advances in measuring satisfaction with nursing care, none instrument is specifically designed to assess satisfaction in intensive care units. Instrument development. The population were all discharged patients (January 2013 - January 2015) from three Intensive Care Units of a third level hospital (N = 200). All assessment instruments were given to discharged patients and 48 hours later, to analyse the temporal stability, only the questionnaire was given again. The validation process of the scale included the analysis of internal consistency, temporal stability; validity of construct through a confirmatory factor analysis; and criterion validity. Reliability was 0.95. The intraclass correlation coefficient for the total scale was 0.83 indicating a good temporal stability. Construct validity showed an acceptable fit and factorial structure with four factors, in accordance with the theoretical model, being Consequences factor the best correlated with other factors. Criterion validity, presented a correlation between low and high (range: 0.42-0.68). The scale has been designed and validated incorporating the perspective of critical care patients. Thanks to its reliability and validity, this questionnaire can be used both in research and in clinical practice. The scale offers a possibility to assess and develop interventions to improve patient satisfaction with nursing care. © 2018 John Wiley & Sons Ltd.

Development, optimization, and single laboratory validation of an event-specific real-time PCR method for the detection and quantification of Golden Rice 2 using a novel taxon-specific assay.

PubMed

Jacchia, Sara; Nardini, Elena; Savini, Christian; Petrillo, Mauro; Angers-Loustau, Alexandre; Shim, Jung-Hyun; Trijatmiko, Kurniawan; Kreysa, Joachim; Mazzara, Marco

2015-02-18

In this study, we developed, optimized, and in-house validated a real-time PCR method for the event-specific detection and quantification of Golden Rice 2, a genetically modified rice with provitamin A in the grain. We optimized and evaluated the performance of the taxon (targeting rice Phospholipase D α2 gene)- and event (targeting the 3' insert-to-plant DNA junction)-specific assays that compose the method as independent modules, using haploid genome equivalents as unit of measurement. We verified the specificity of the two real-time PCR assays and determined their dynamic range, limit of quantification, limit of detection, and robustness. We also confirmed that the taxon-specific DNA sequence is present in single copy in the rice genome and verified its stability of amplification across 132 rice varieties. A relative quantification experiment evidenced the correct performance of the two assays when used in combination.

Towards muscle-specific meat color stability of Chinese Luxi yellow cattle: A proteomic insight into post-mortem storage.

PubMed

Wu, Wei; Yu, Qian-Qian; Fu, Yu; Tian, Xiao-Jing; Jia, Fei; Li, Xing-Min; Dai, Rui-Tong

2016-09-16

Searching for potential predictors of meat color is a challenging task for the meat industry. In this study, the relationship between meat color parameters and the sarcoplasmic proteome of M. longissimuss lumborum (LL) and M. psoas major (PM) from Chinese Luxi yellow cattle during post-mortem storage (0, 5, 10 and 15days) were explored with the aid of the integrated proteomics and bioinformatics approaches. Meat color attributes revealed that LL displayed better color stability than PM during storage. Furthermore, sarcoplasmic proteins of these two muscles were compared between days 5, 10, 15 and day 0. Several proteins were closely correlated with meat color attributes and they were muscle-specific and responsible for the meat color stability at different storage periods. Glycerol-3-phosphate dehydrogenase, fructose-bisphosphate aldolase A isoform, glycogen phosphorylase, peroxiredoxin-2, phosphoglucomutase-1, superoxide dismutase [Cu-Zn], heat shock cognate protein (71kDa) might serve as the candidate predictors of meat color stability during post-mortem storage. In addition, bioinformatics analyses indicated that more proteins were involved in glycolytic metabolism of LL, which contributed to better meat color stability of LL than PM. The present results could provide a proteomic insight into muscle-specific meat color stability of Chinese Luxi yellow cattle during post-mortem storage. Copyright © 2015 Elsevier B.V. All rights reserved.

Validating Migraine-Specific Quality of Life Questionnaire v2.1 in episodic and chronic migraine.

PubMed

Bagley, Christine L; Rendas-Baum, Regina; Maglinte, Gregory A; Yang, Min; Varon, Sepideh F; Lee, Jeff; Kosinski, Mark

2012-03-01

To provide evidence for the reliability and validity of the Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ) for use in chronic migraine (CM) in adults. MSQ is one of the most frequently utilized disease-specific tools assessing impact of migraine on health-related quality of life (HRQL). However, evidence for its reliability and validity are based on studies in episodic migraine (EM) populations. Additional studies assessing the reliability and validity of the MSQ in patients with CM are needed. Cross-sectional data were collected via web-based survey in 9 countries/regions. Participants were classified as having CM (≥15 headache days/month) or EM (<15 headache days/month). Three MSQ domains - Role Function-Preventive (RP), Role Function-Restrictive (RR), and Emotional Function (EF) - were rescaled to 0-100, where higher scores indicate better HRQL, and analyzed for internal consistency reliability (Cronbach's α), construct validity (correlations between MSQ scales and measures of depression/anxiety [Patient Health Questionnaire; PHQ-4], disability [Migraine Disability Assessment Questionnaire; MIDAS], and functional impact [Headache Impact Test; HIT-6], where lower scores indicate better HRQL for each measure), as well as discriminant validity across migraine groups. A total of 8726 eligible respondents were classified: 5.7% CM (n = 499) and 94.3% EM (n = 8227). Subjects were mostly female (83.5%) with a mean (±SD) age of 40.3 ± 11.4, and were similar between the 2 groups. MSQ domain scores for CM and EM groups, respectively, were: RP = 61.4 ± 26.1 and 71.7 ± 24.0; RR = 44.4 ± 22.1 and 56.5 ± 24.1; EF = 48.3 ± 28.1 and 67.2 ± 26.7. Internal consistency of the overall sample for RP, RR, and EF was 0.90, 0.96, and 0.87, respectively. Similar values were observed for CM and EM. MSQ scores for the overall sample correlated moderately to highly with scores from the PHQ-4 (r = -0.21 to -0.42), MIDAS (r = -0.38 to -0.39), and HIT-6 (r = -0

Scale indicators of social exchange relationships: a comparison of relative content validity.

PubMed

Colquitt, Jason A; Baer, Michael D; Long, David M; Halvorsen-Ganepola, Marie D K

2014-07-01

Although social exchange theory has become one of the most oft-evoked theories in industrial and organizational psychology, there remains no consensus about how to measure its key mechanism: social exchange relationships (Blau, 1964). Drawing on Cropanzano and Byrne's (2000) review of contemporary social exchange theorizing, we examined the content validity of perceived support, exchange quality, affective commitment, trust, and psychological contract fulfillment as indicators of social exchange relationships. We used Hinkin and Tracey's (1999) quantitative approach to content validation, which asks participants to rate the correspondence between scale items and definitions of intended (and unintended) constructs. Our results revealed that some of the most frequently utilized indicators of social exchange relationships--perceived support and exchange quality--were significantly less content valid than rarely used options like affect-based trust. Our results also revealed that 2 direct measures--Bernerth, Armenakis, Feild, Giles, and Walker's (2007) scale and a scale created for this study--were content valid. We discuss the implications of these results for future applications of social exchange theory.

A Stability Indicating HPLC Method for the Determination of Fluvoxamine in Pharmaceutical Dosage Forms.

PubMed

Souri, Effat; Donyayi, Hassan; Khaniha, Reza Ahmad; Barazandeh Tehrani, Maliheh

2015-01-01

Fluvoxamine maleate is a selective serotonin reuptake inhibitor, which is used for the treatment of different types of depressive disorders. In the present study, a stability indicating HPLC method was developed and validated for the determination of fluvoxamine maleate. The chromatographic separation was carried out using a Nova-Pak CN column and a mixture of K2HPO4 50 mM (pH 7.0) and acetonitrile (60: 40, v/v) as the mobile phase. Target compounds were detected using a UV detector set at 235 nm. The developed method was linear over the concentration range of 1-80 μg/ml with acceptable precision (CV values < 2.0%) and accuracy (error values < 1.6%). The degradation studies showed that fluvoxamine maleate is relatively unstable under acidic, basic and oxidative conditions and also when exposed to UV radiation. On the other hand, the bulk powder of fluvoxamine maleate was relatively stable when exposed to visible light or heat. The proposed method was successfully applied for the determination of active ingredient of fluvoxamine dosage form without any interference from tablet excipients.

Stability evaluation of tramadol enantiomers using a chiral stability-indicating capillary electrophoresis method and its application to pharmaceutical analysis.

PubMed

Mohammadi, Ali; Nojavan, Saeed; Rouini, Mohammadreza; Fakhari, Ali Reza

2011-07-01

In this study, a chiral stability-indicating CE assay was developed for the stability evaluation of tramadol (TR) enantiomers in commercial tablets using maltodextrin as chiral selector. To investigate the stability-indicating power of the analytical method as well as stability evaluation of TR enantiomers, active pharmaceutical ingredient and TR tablets were subjected to photolysis, heat, oxidation and hydrolysis to conduct stress testing. Best separation for the TR enantiomers was achieved on an uncoated fused-silica capillary at 20 °C using borate buffer (50 mM, pH 10.2) containing 10% m/v maltodextrin. All determinations were performed by a UV detector at 214 nm. A constant voltage of 20 kV was applied to obtain the separation. The range of quantitation for both enantiomers was 5-100 μg/mL (R>0.996). Intra- and inter-day RSD (n=6) were less than 10%. The percent relevant errors were obtained to be less than 4.0 for both enantiomers. The limits of quantitation and detection for both enantiomers were 5 and 1.5 μg/mL, respectively. Degradation products resulting from the stress studies were the same for both enantiomers and did not interfere with the detection of the enantiomers. Copyright © 2011 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Validation of the Spanish Version of the Mammography-Specific Self-Efficacy Scale.

PubMed

Jerome-D'Emilia, Bonnie; Suplee, Patricia; Akincigil, Ayse

2015-05-01

To consider psychometric estimates of the validity and reliability of the Spanish translation of a mammography-specific self-efficacy scale. A cross-sectional study. Three primarily Hispanic churches and a Hispanic community center in a low-income urban area of New Jersey. 153 low-income Hispanic women aged 40-85 years. The translated scale was administered to participants during a six-month period. Internal consistency, reliability, and construct and predictive validity were assessed. Demographic variables included income and insurance status. Outcome variables included total mammography-specific self-efficacy and having had a mammogram within the past two years. Preliminary evidence of reliability and validity were found, and predictive validity was demonstrated. The health needs of specific populations can be addressed only when research instruments have been appropriately validated and all relevant factors are considered. Diverse groups of low-income women face similar challenges and barriers in their efforts to get screened. Nurses are in an ideal position to help women with preventive care decision making (e.g., screening for breast cancer). Understanding how a woman's level of self-efficacy affects her decision making should be considered when counseling a client.

Development and validation of a stability-indicating gas chromatographic method for quality control of residual solvents in blonanserin: a novel atypical antipsychotic agent.

PubMed

Peng, Ming; Liu, Jin; Lu, Dan; Yang, Yong-Jian

2012-09-01

Blonanserin is a novel atypical antipsychotic agent for the treatment of schizophrenia. Ethyl alcohol, isopropyl alcohol and toluene are utilized in the synthesis route of this bulk drug. A new validated gas chromatographic (GC) method for the simultaneous determination of residual solvents in blonanserin is described in this paper. Blonanserin was dissolved in N, N-dimethylformamide to make a sample solution that was directly injected into a DB-624 column. A postrun oven temperature at 240°C for approximately 2 h after the analysis cycle was performed to wash out blonanserin residue in the GC column. Quantitation was performed by external standard analyses and the validation was carried out according to International Conference on Harmonization validation guidelines Q2A and Q2B. The method was shown to be specific (no interference in the blank solution), linear (correlation coefficients ≥0.99998, n = 10), accurate (average recoveries between 94.1 and 101.7%), precise (intra-day and inter-day precision ≤2.6%), sensitive (limit of detection ≤0.2 ng, and limit of quantitation ≤0.7 ng), robust (small variations of carrier gas flow, initial oven temperature, temperature ramping rate, injector and detector temperatures did not significantly affect the system suitability test parameters and peak areas) and stable (reference standard and sample solutions were stable over 48 h). This extensively validated method is ready to be used for the quality control of blonanserin.

The stability cycle—A universal pathway for the stability of films over topography

NASA Astrophysics Data System (ADS)

Schörner, Mario; Aksel, Nuri

2018-01-01

In the present study on the linear stability of gravity-driven Newtonian films flowing over inclined topographies, we consider a fundamental question: Is there a universal principle, being valid to describe the parametric evolution of the flow's stability chart for variations of different system parameters? For this sake, we first screened all experimental and numerical stability charts available in the literature. In a second step, we performed experiments to fill the gaps which remained. Variations of the fluid's viscosity and the topography's specific shape, amplitude, wavelength, tip width, and inclination were considered. That way, we identified a set of six characteristic patterns of stability charts to be sufficient to describe and unify all results on the linear stability of Newtonian films flowing over undulated inclines. We unveiled a universal pathway—the stability cycle—along which the linear stability charts of all considered Newtonian films flowing down periodically corrugated inclines evolved when the system parameters were changed.

Stability indicating HPLC method for simultaneous determination of mephenesin and diclofenac diethylamine.

PubMed

Mulgund, S V; Phoujdar, M S; Londhe, S V; Mallade, P S; Kulkarni, T S; Deshpande, A S; Jain, K S

2009-01-01

A simple, specific, accurate and stability-indicating reversed phase high performance liquid chromatographic method was developed for the simultaneous determination of mephenesin and diclofenac diethylamine, using a Spheri-5-RP-18 column and a mobile phase composed of methanol: water (70:30, v/v), pH 3.0 adjusted with o-phosphoric acid. The retention times of mephenesin and diclofenac diethylamine were found to be 3.9 min and 14.5 min, respectively. Linearity was established for mephenesin and diclofenac diethylamine in the range of 50-300 mug/ml and 10-60 mug/ml, respectively. The percentage recoveries of mephenesin and diclofenac diethylamine were found to be in the range of 99.06-100.60% and 98.95-99.98%, respectively. Both the drugs were subjected to acid, alkali and neutral hydrolysis, oxidation, dry heat, photolytic and UV degradation. The degradation studies indicated, mephenesin to be susceptible to neutral hydrolysis, while diclofenac diethylamine showed degradation in acid, H(2)O(2), photolytic and in presence of UV radiation. The degradation products of diclofenac diethylamine in acidic and photolytic conditions were well resolved from the pure drug with significant differences in their retention time values. This method can be successfully employed for simultaneous quantitative analysis of mephenesin and diclofenac diethylamine in bulk drugs and formulations.

Stability-indicating methods for the determination of piretanide in presence of the alkaline induced degradates.

PubMed

Youssef, Nadia F

2005-10-04

Stability-indicating high performance liquid chromatography (HPLC), thin-layer chromatography (TLC) and first-derivative of ratio spectra (1DD) methods are developed for the determination of piretanide in presence of its alkaline induced degradates. HPLC method depends on separation of piretanide from its degradates on mu-Bondapak C18 column using methanol:water:acetic acid (70:30:1, v/v/v) as a mobile phase at flow rate 1.0 ml/min and UV detector at 275 nm. TLC densitometic method is based on the difference in Rf-values between the intact drug and its degradates on thin-layer silica gel. Iso-propanol:ammonia 33% (8:2, v/v) was used as a developing mobile phase and the chromatogram was scanned at 275 nm. The derivative of ratio spectra method (1DD) depends on the measurement of the absorbance at 288 nm in the first-derivative of ratio spectra for the determination of the cited drug in the presence of its degradates. Calibration graphs of the three suggested methods are linear in the concentration ranges 0.02-0.3 microg/20 microl, 0.5-10 microg/spot and 5-50 microg/ml, with mean percentage recovery 99.27+/-0.52, 99,17+/-1.01 and 99.65+/-1.01%, respectively. The three proposed methods were successfully applied for the determination of piretanide in bulk powder, laboratory-prepared mixtures and pharmaceutical dosage form with good accuracy and precision. The results were statistically analyzed and compared with those obtained by the official method. Validation of the method was determined with favourable specificity, linearity, precision, and accuracy was assessed by applying the standard addition technique.

Adaptation and validation of indicators concerning the sterilization process of supplies in Primary Health Care services.

PubMed

Passos, Isis Pienta Batista Dias; Padoveze, Maria Clara; Roseira, Camila Eugênia; de Figueiredo, Rosely Moralez

2015-01-01

to adapt and validate, by expert consensus, a set of indicators used to assess the sterilization process of dental, medical and hospital supplies to be used in PHC services. qualitative methodological study performed in two stages. The first stage included a focal group composed of experts to adapt the indicators to be used in PHC. In the second stage, the indicators were validated using a 4-point Likert scale, which was completed by judges. A Content Validity Index of ≥ 0.75 was considered to show approval of the indicators. the adaptations implemented by the focal group mainly referred to the physical structure, inclusion of dental care professionals, inclusion of chemical disinfection, and replacement of the hot air and moist heat sterilization methods. The validation stage resulted in an index of 0.96, which ranged from 0.90 to 1.00, for the components of the indicators. the judges considered the indicators after adaptation to be validated. Even though there may be differences among items processed around the world, there certainly are common characteristics, especially in countries with economic and cultural environments similar to Brazil. The inclusion of these indicators to assess the safety of healthcare supplies used in PHC services should be considered.

NASA software specification and evaluation system: Software verification/validation techniques

NASA Technical Reports Server (NTRS)

1977-01-01

NASA software requirement specifications were used in the development of a system for validating and verifying computer programs. The software specification and evaluation system (SSES) provides for the effective and efficient specification, implementation, and testing of computer software programs. The system as implemented will produce structured FORTRAN or ANSI FORTRAN programs, but the principles upon which SSES is designed allow it to be easily adapted to other high order languages.

Application of normal fluorescence and stability-indicating derivative synchronous fluorescence spectroscopy for the determination of gliquidone in presence of its fluorescent alkaline degradation product

NASA Astrophysics Data System (ADS)

El-ghobashy, Mohamed R.; Yehia, Ali M.; Helmy, Aya H.; Youssef, Nadia F.

2018-01-01

Simple, smart and sensitive normal fluorescence and stability-indicating derivative synchronous spectrofluorimetric methods have been developed and validated for the determination of gliquidone in the drug substance and drug product. Normal spectrofluorimetric method of gliquidone was established in methanol at λ excitation 225 nm and λ emission 400 nm in concentration range 0.2-3 μg/ml with LOD equal 0.028. The fluorescence quantum yield of gliquidone was calculated using quinine sulfate as a reference and found to be 0.542. Stability-indicating first and third derivative synchronous fluorescence spectroscopy were successfully utilized to overcome the overlapped spectra in normal fluorescence of gliquidone and its alkaline degradation product. Derivative synchronous methods are based on using the synchronous fluorescence of gliquidone and its degradation product in methanol at Δ λ50 nm. Peak amplitude in the first derivative of synchronous fluorescence spectra was measured at 309 nm where degradation product showed zero-crossing without interference. The peak amplitudes in the third derivative of synchronous fluorescence spectra, peak to trough were measured at 316,329 nm where degradation product showed zero-crossing. The different experimental parameters affecting the normal and synchronous fluorescence intensity of gliquidone were studied and optimized. Moreover, the cited methods have been validated as per ICH guidelines. The peak amplitude-concentration plots of the derivative synchronous fluorescence were linear over the concentration range 0.05-2 μg/ml for gliquidone. Limits of detection were 0.020 and 0.022 in first and third derivative synchronous spectra, respectively. The adopted methods were successfully applied to commercial tablets and the results demonstrated that the derivative synchronous fluorescence spectroscopy is a powerful stability-indicating method, suitable for routine use with a short analysis time. Statistical comparison between

Validation of the World Health Organization Enzyme-Linked Immunosorbent Assay for the Quantitation of Immunoglobulin G Serotype-Specific Anti-Pneumococcal Antibodies in Human Serum

PubMed Central

2017-01-01

The World Health Organization (WHO) enzyme-linked immunosorbent assay (ELISA) guideline is currently accepted as the gold standard for the evaluation of immunoglobulin G (IgG) antibodies specific to pneumococcal capsular polysaccharide. We conducted validation of the WHO ELISA for 7 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, and 23F) by evaluating its specificity, precision (reproducibility and intermediate precision), accuracy, spiking recovery test, lower limit of quantification (LLOQ), and stability at the Ewha Center for Vaccine Evaluation and Study, Seoul, Korea. We found that the specificity, reproducibility, and intermediate precision were within acceptance ranges (reproducibility, coefficient of variability [CV] ≤ 15%; intermediate precision, CV ≤ 20%) for all serotypes. Comparisons between the provisional assignments of calibration sera and the results from this laboratory showed a high correlation > 94% for all 7 serotypes, supporting the accuracy of the ELISA. The spiking recovery test also fell within an acceptable range. The quantification limit, calculated using the LLOQ, for each of the serotypes was 0.05–0.093 μg/mL. The freeze-thaw stability and the short-term temperature stability were also within an acceptable range. In conclusion, we showed good performance using the standardized WHO ELISA for the evaluation of serotype-specific anti-pneumococcal IgG antibodies; the WHO ELISA can evaluate the immune response against pneumococcal vaccines with consistency and accuracy. PMID:28875600

Soil-Geosynthetic Interaction Test to Develop Specifications for Geosynthetic-Stabilized Roadways

DOT National Transportation Integrated Search

2018-05-01

soil-geosynthetic composite (KSGC) for a wide range of geosynthetics. The tests were conducted after establishment of test configurations that were found suitable for specification of geosynthetic-stabilized base roadways. Field performance of experi...

Simultaneous, stability indicating, HPLC-DAD determination of guaifenesin and methyl and propyl-parabens in cough syrup.

PubMed

Grosa, Giorgio; Del Grosso, Erika; Russo, Roberta; Allegrone, Gianna

2006-06-07

A stability indicating high performance liquid chromatography procedure has been developed for the simultaneous determination of guaifenesin (GUA), methyl p-hydroxybenzoate (MHB) and propyl p-hydroxybenzoate (PHB) in a commercial cough syrup dosage form. The method was specific and stability indicating as chromatographic conditions were selected to provide adequate separation of GUA, MHB and PHB from the putative degradation products guaiacol (GUAI) and p-hydroxybenzoic acid (HBA) as well as from excipients. The isocratic separation and quantitation were achieved within 17 min on a 150-mm column with an ether-linked phenyl stationary phase and a hydrophilic endcapping. The mobile phase was constituted of eluant A: aqueous phosphate buffer (pH 3.0, 10 mM)/acetonitrile 25/75 (v/v) and eluant B:methanol; the A:B ratio was 85:15 (v/v) with a flow rate 1 ml min-1 and detection of analytes at 254 and 276 nm. The method showed good linearity for the GUA-MHB-PHB mixture in the 95-285, 4-12, and 1-3 microg ml-1 ranges, respectively, being all the square of the correlation coefficients greater than 0.999. The interday R.S.D.s were 1.17, 1.14, and 0.91%, for GUA, MHB, and PHP, respectively. The method demonstrated also to be accurate; indeed the average recoveries, at 100% of the target assay concentration, were 100.5, 100.3, and 100.7% with relative standard deviations of 0.8, 0.7, and 0.4% for GUA, MHB, and PHB, respectively, from laboratory prepared samples. The applicability of the method was evaluated in commercial dosage form analysis as well as in stability studies.

Specialty-specific multi-source feedback: assuring validity, informing training.

PubMed

Davies, Helena; Archer, Julian; Bateman, Adrian; Dewar, Sandra; Crossley, Jim; Grant, Janet; Southgate, Lesley

2008-10-01

The white paper 'Trust, Assurance and Safety: the Regulation of Health Professionals in the 21st Century' proposes a single, generic multi-source feedback (MSF) instrument in the UK. Multi-source feedback was proposed as part of the assessment programme for Year 1 specialty training in histopathology. An existing instrument was modified following blueprinting against the histopathology curriculum to establish content validity. Trainees were also assessed using an objective structured practical examination (OSPE). Factor analysis and correlation between trainees' OSPE performance and the MSF were used to explore validity. All 92 trainees participated and the assessor response rate was 93%. Reliability was acceptable with eight assessors (95% confidence interval 0.38). Factor analysis revealed two factors: 'generic' and 'histopathology'. Pearson correlation of MSF scores with OSPE performances was 0.48 (P = 0.001) and the histopathology factor correlated more highly (histopathology r = 0.54, generic r = 0.42; t = - 2.76, d.f. = 89, P < 0.01). Trainees scored least highly in relation to ability to use histopathology to solve clinical problems (mean = 4.39) and provision of good reports (mean = 4.39). Three of six doctors whose means were < 4.0 received free text comments about report writing. There were 83 forms with aggregate scores of < 4. Of these, 19.2% included comments about report writing. Specialty-specific MSF is feasible and achieves satisfactory reliability. The higher correlation of the 'histopathology' factor with the OSPE supports validity. This paper highlights the importance of validating an MSF instrument within the specialty-specific context as, in addition to assuring content validity, the PATH-SPRAT (Histopathology-Sheffield Peer Review Assessment Tool) also demonstrates the potential to inform training as part of a quality improvement model.

Cross-cultural validity of Morningness-Eveningness Stability Scale improved (MESSi) in Iran, Spain and Germany.

PubMed

Rahafar, Arash; Randler, Christoph; Díaz-Morales, Juan F; Kasaeian, Ali; Heidari, Zeinab

2017-01-01

Morningness-Eveningness Stability Scale improved (MESSi) is a newly constructed measure to assess circadian types and amplitude. In this study, we applied this measure to participants from three different countries: Germany, Spain and Iran. Confirmatory factorial analysis (CFA) of MESSi displayed mediocre fit in the three countries. Comparing increasingly stringent models using multigroup confirmatory factor analyses indicated at least partial measurement invariance (metric invariance) by country for Morning Affect and Distinctness subscales. Age was positively related to Morning Affect (MA), and negatively related to Eveningness (EV) and Distinctness (DI). Men reported higher MA than women, whereas women reported higher DI than men. Regarding country effect, Iranian participants reported highest MA compared to Spaniards and Germans, whereas Germans reported higher DI compared to Iranians and Spaniards. As a conclusion, our study corroborated the validity and reliability of MESSi across three different countries with different geographical and cultural characteristics.

Validated stability-indicating spectrofluorimetric methods for the determination of ebastine in pharmaceutical preparations

PubMed Central

2011-01-01

Two sensitive, selective, economic, and validated spectrofluorimetric methods were developed for the determination of ebastine (EBS) in pharmaceutical preparations depending on reaction with its tertiary amino group. Method I involves condensation of the drug with mixed anhydrides (citric and acetic anhydrides) producing a product with intense fluorescence, which was measured at 496 nm after excitation at 388 nm. Method (IIA) describes quantitative fluorescence quenching of eosin upon addition of the studied drug where the decrease in the fluorescence intensity was directly proportional to the concentration of ebastine; the fluorescence quenching was measured at 553 nm after excitation at 457 nm. This method was extended to (Method IIB) to apply first and second derivative synchronous spectrofluorimetric method (FDSFS & SDSFS) for the simultaneous analysis of EBS in presence of its alkaline, acidic, and UV degradation products. The proposed methods were successfully applied for the determination of the studied compound in its dosage forms. The results obtained were in good agreement with those obtained by a comparison method. Both methods were utilized to investigate the kinetics of the degradation of the drug. PMID:21385439

Introducing conjoint analysis method into delayed lotteries studies: its validity and time stability are higher than in adjusting.

PubMed

Białek, Michał; Markiewicz, Łukasz; Sawicki, Przemysław

2015-01-01

The delayed lotteries are much more common in everyday life than are pure lotteries. Usually, we need to wait to find out the outcome of the risky decision (e.g., investing in a stock market, engaging in a relationship). However, most research has studied the time discounting and probability discounting in isolation using the methodologies designed specifically to track changes in one parameter. Most commonly used method is adjusting, but its reported validity and time stability in research on discounting are suboptimal. The goal of this study was to introduce the novel method for analyzing delayed lotteries-conjoint analysis-which hypothetically is more suitable for analyzing individual preferences in this area. A set of two studies compared the conjoint analysis with adjusting. The results suggest that individual parameters of discounting strength estimated with conjoint have higher predictive value (Study 1 and 2), and they are more stable over time (Study 2) compared to adjusting. We discuss these findings, despite the exploratory character of reported studies, by suggesting that future research on delayed lotteries should be cross-validated using both methods.

Introducing conjoint analysis method into delayed lotteries studies: its validity and time stability are higher than in adjusting

PubMed Central

Białek, Michał; Markiewicz, Łukasz; Sawicki, Przemysław

2015-01-01

The delayed lotteries are much more common in everyday life than are pure lotteries. Usually, we need to wait to find out the outcome of the risky decision (e.g., investing in a stock market, engaging in a relationship). However, most research has studied the time discounting and probability discounting in isolation using the methodologies designed specifically to track changes in one parameter. Most commonly used method is adjusting, but its reported validity and time stability in research on discounting are suboptimal. The goal of this study was to introduce the novel method for analyzing delayed lotteries—conjoint analysis—which hypothetically is more suitable for analyzing individual preferences in this area. A set of two studies compared the conjoint analysis with adjusting. The results suggest that individual parameters of discounting strength estimated with conjoint have higher predictive value (Study 1 and 2), and they are more stable over time (Study 2) compared to adjusting. We discuss these findings, despite the exploratory character of reported studies, by suggesting that future research on delayed lotteries should be cross-validated using both methods. PMID:25674069

A Validation of Object-Oriented Design Metrics as Quality Indicators

NASA Technical Reports Server (NTRS)

Basili, Victor R.; Briand, Lionel C.; Melo, Walcelio

1997-01-01

This paper presents the results of a study in which we empirically investigated the suits of object-oriented (00) design metrics introduced in another work. More specifically, our goal is to assess these metrics as predictors of fault-prone classes and, therefore, determine whether they can be used as early quality indicators. This study is complementary to the work described where the same suite of metrics had been used to assess frequencies of maintenance changes to classes. To perform our validation accurately, we collected data on the development of eight medium-sized information management systems based on identical requirements. All eight projects were developed using a sequential life cycle model, a well-known 00 analysis/design method and the C++ programming language. Based on empirical and quantitative analysis, the advantages and drawbacks of these 00 metrics are discussed. Several of Chidamber and Kamerer's 00 metrics appear to be useful to predict class fault-proneness during the early phases of the life-cycle. Also, on our data set, they are better predictors than 'traditional' code metrics, which can only be collected at a later phase of the software development processes.

Noncredible cognitive performance at clinical evaluation of adult ADHD: An embedded validity indicator in a visuospatial working memory test.

PubMed

Fuermaier, Anselm B M; Tucha, Oliver; Koerts, Janneke; Lange, Klaus W; Weisbrod, Matthias; Aschenbrenner, Steffen; Tucha, Lara

2017-12-01

The assessment of performance validity is an essential part of the neuropsychological evaluation of adults with attention-deficit/hyperactivity disorder (ADHD). Most available tools, however, are inaccurate regarding the identification of noncredible performance. This study describes the development of a visuospatial working memory test, including a validity indicator for noncredible cognitive performance of adults with ADHD. Visuospatial working memory of adults with ADHD (n = 48) was first compared to the test performance of healthy individuals (n = 48). Furthermore, a simulation design was performed including 252 individuals who were randomly assigned to either a control group (n = 48) or to 1 of 3 simulation groups who were requested to feign ADHD (n = 204). Additional samples of 27 adults with ADHD and 69 instructed simulators were included to cross-validate findings from the first samples. Adults with ADHD showed impaired visuospatial working memory performance of medium size as compared to healthy individuals. Simulation groups committed significantly more errors and had shorter response times as compared to patients with ADHD. Moreover, binary logistic regression analysis was carried out to derive a validity index that optimally differentiates between true and feigned ADHD. ROC analysis demonstrated high classification rates of the validity index, as shown in excellent specificity (95.8%) and adequate sensitivity (60.3%). The visuospatial working memory test as presented in this study therefore appears sensitive in indicating cognitive impairment of adults with ADHD. Furthermore, the embedded validity index revealed promising results concerning the detection of noncredible cognitive performance of adults with ADHD. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Concurrent Validation of the Clinical Opiate Withdrawal Scale (COWS) and Single-Item Indices against the Clinical Institute Narcotic Assessment (CINA) Opioid Withdrawal Instrument

PubMed Central

Tompkins, D. Andrew; Bigelow, George E.; Harrison, Joseph A.; Johnson, Rolley E.; Fudala, Paul J.; Strain, Eric C.

2009-01-01

Introduction The Clinical Opiate Withdrawal Scale (COWS) is an 11-item clinician-administered scale assessing opioid withdrawal. Though commonly used in clinical practice, it has not been systematically validated. The present study validated the COWS in comparison to the validated Clinical Institute Narcotic Assessment (CINA) scale. Method Opioid-dependent volunteers were enrolled in a residential trial and stabilized on morphine 30 mg given subcutaneously four times daily. Subjects then underwent double-blind, randomized challenges of intramuscularly administered placebo and naloxone (0.4 mg) on separate days, during which the COWS, CINA, and visual analog scale (VAS) assessments were concurrently obtained. Subjects completing both challenges were included (N=46). Correlations between mean peak COWS and CINA scores as well as self-report VAS questions were calculated. Results Mean peak COWS and CINA scores of 7.6 and 24.4, respectively, occurred on average 30 minutes post-injection of naloxone. Mean COWS and CINA scores 30 minutes after placebo injection were 1.3 and 18.9, respectively. The Pearson correlation coefficient for peak COWS and CINA scores during the naloxone challenge session was 0.85 (p<0.001). Peak COWS scores also correlated well with peak VAS self-report scores of bad drug effect (r=0.57, p<0.001) and feeling sick (r=0.57, p<0.001), providing additional evidence of concurrent validity. Placebo was not associated with any significant elevation of COWS, CINA, or VAS scores, indicating discriminant validity. Cronbach’s alpha for the COWS was 0.78, indicating good internal consistency (reliability). Discussion COWS, CINA, and certain VAS items are all valid measurement tools for acute opiate withdrawal. PMID:19647958

Validation of the German version of the Burn Specific Health Scale-Brief (BSHS-B).

PubMed

Müller, Astrid; Smits, Dirk; Jasper, Stefanie; Berg, Lea; Claes, Laurence; Ipaktchi, Ramin; Vogt, Peter M; de Zwaan, Martina

2015-09-01

The Burn Specific Health Scale-Brief (BSHS-B) is recognized as a valid self-rating scale to evaluate quality of life after burn. To validate the translated German version of the BSHS-B. One hundred and forty one burn survivors (65.2% men) with a mean age of 49.62 years (SD=15.16) and a mean duration after burn of 45.01 months (SD=26.18) answered the BSHS-B. Factor structure was tested by using confirmatory factor analysis, reliability (internal consistency) of the scales was determined by means of Cronbach's α. Construct validity was explored through correlations between the BSHS-B and the Short-Form 8 Health Survey (SF-8). In addition, the know-groups technique was used to determine to which degree the BSHS-B discriminates between patients with low and high burn severity based on the abbreviated burn severity index (ABSI). The Hospital Anxiety and Depression Scale (HADS) was used to examine criterion validity. The nine BSHS-B subscales showed good internal consistency. A second-order confirmatory factor analysis revealed the following main components: (1) Affect and Relationship, (2) Function and (3) Skin Involvement. The second-order factors were positively correlated with the SF-8 and negatively correlated with symptoms of anxiety and depression. Patients with low ABSI scored higher on all three BSHS-B domains than those with high ABSI. The results indicate good psychometric properties of the German BSHS-B. Further studies are needed to investigate the utility of the questionnaire in clinical routine practice, evaluation of burn management programs, and burn-specific research. Copyright © 2015 Elsevier Ltd and ISBI. All rights reserved.

Head and neck cancer-specific quality of life: instrument validation.

PubMed

Terrell, J E; Nanavati, K A; Esclamado, R M; Bishop, J K; Bradford, C R; Wolf, G T

1997-10-01

The disfigurement and dysfunction associated with head and neck cancer affect emotional well-being and some of the most basic functions of life. Most cancer-specific quality-of-life assessments give a single composite score for head and neck cancer-related quality of life. To develop and evaluate an improved multidimensional instrument to assess head and neck cancer-related functional status and well-being. The item selection process included literature review, interviews with health care workers, and patient surveys. A survey with 37 disease-specific questions and the SF-12 survey were administered to 253 patients in 3 large medical centers. Factor analysis was performed to identify disease-specific domains. Domain scores were calculated as the standardized score of the component items. These domains were assessed for construct validity based on clinical hypotheses and test-retest reliability. Four relevant domains were identified: Eating (6 items), Communication (4 items), Pain (4 items), and Emotion (6 items). Each had an internal consistency (Cronbach alpha value) of greater than 0.80. Construct validity was demonstrated by moderate correlations with the SF-12 Physical and Mental component scores (r=0.43-0.60). Test-retest reliability for each domain demonstrated strong reliability between the 2 time points. Correlations were strong for each individual question, ranging from 0.53 to 0.93. Construct validity testing demonstrated that the direction of differences for each domain were as hypothesized. The Head and Neck Quality of Life questionnaire is a promising multidimensional tool with which to assess head and neck cancer-specific quality of life.

New Stability-Indicating RP-HPLC Method for Determination of Diclofenac Potassium and Metaxalone from their Combined Dosage Form

PubMed Central

Panda, Sagar Suman; Patanaik, Debasis; Ravi Kumar, Bera V. V.

2012-01-01

A simple, precise and accurate isocratic RP-HPLC stability-indicating assay method has been developed to determine diclofenac potassium and metaxalone in their combined dosage forms. Isocratic separation was achieved on a Hibar-C18, Lichrosphere-100® (250 mm × 4.6 mm i.d., particle size 5 μm) column at room temperature in isocratic mode, the mobile phase consists of methanol: water (80:20, v/v) at a flow rate of 1.0 ml/min, the injection volume was 20 μl and UV detection was carried out at 280nm. The drug was subjected to acid and alkali hydrolysis, oxidation, photolysis and heat as stress conditions. The method was validated for specificity, linearity, precision, accuracy, robustness and system suitability. The method was linear in the drug concentration range of 2.5–30 μg/ml and 20–240 μg/ml for diclofenac potassium and metaxalone, respectively. The precision (RSD) of six samples was 0.83 and 0.93% for repeatability, and the intermediate precision (RSD) among six-sample preparation was 1.63 and 0.49% for diclofenac potassium and metaxalone, respectively. The mean recoveries were between 100.99–102.58% and 99.97–100.01% for diclofenac potassium and metaxalone, respectively. The proposed method can be used successfully for routine analysis of the drug in bulk and combined pharmaceutical dosage forms. PMID:22396909

Development and validation of the Perceived Game-Specific Soccer Competence Scale.

PubMed

Forsman, Hannele; Gråstén, Arto; Blomqvist, Minna; Davids, Keith; Liukkonen, Jarmo; Konttinen, Niilo

2016-07-01

The objective of this study was to create a valid, self-reported, game-specific soccer competence scale. A structural model of perceived competence, performance measures and motivation was tested as the basis for the scale. A total of 1321 soccer players (261 females, 1060 males) ranging from 12 to 15 years (13.4 ± 1.0 years) participated in the study. They completed the Perceived Game-Specific Soccer Competence Scale (PGSSCS), self-assessments of tactical skills and motivation, as well as technical and speed and agility tests. Results of factor analyses, tests of internal consistency and correlations between PGSSCS subscales, performance measures and motivation supported the reliability and validity of the PGSSCS. The scale can be considered a suitable instrument to assess perceived game-specific competence among young soccer players.

Validation of a high performance liquid chromatography method for the stabilization of epigallocatechin gallate.

PubMed

Fangueiro, Joana F; Parra, Alexander; Silva, Amélia M; Egea, Maria A; Souto, Eliana B; Garcia, Maria L; Calpena, Ana C

2014-11-20

Epigallocatechin gallate (EGCG) is a green tea catechin with potential health benefits, such as anti-oxidant, anti-carcinogenic and anti-inflammatory effects. In general, EGCG is highly susceptible to degradation, therefore presenting stability problems. The present paper was focused on the study of EGCG stability in HEPES (N-2-hydroxyethylpiperazine-N'-2-ethanesulfonic acid) medium regarding the pH dependency, storage temperature and in the presence of ascorbic acid a reducing agent. The evaluation of EGCG in HEPES buffer has demonstrated that this molecule is not able of maintaining its physicochemical properties and potential beneficial effects, since it is partially or completely degraded, depending on the EGCG concentration. The storage temperature of EGCG most suitable to maintain its structure was shown to be the lower values (4 or -20 °C). The pH 3.5 was able to provide greater stability than pH 7.4. However, the presence of a reducing agent (i.e., ascorbic acid) was shown to provide greater protection against degradation of EGCG. A validation method based on RP-HPLC with UV-vis detection was carried out for two media: water and a biocompatible physiological medium composed of Transcutol®P, ethanol and ascorbic acid. The quantification of EGCG for purposes, using pure EGCG, requires a validated HPLC method which could be possible to apply in pharmacokinetic and pharmacodynamics studies. Copyright © 2014. Published by Elsevier B.V.

Stability Indicating HPLC Method for Simultaneous Determination of Mephenesin and Diclofenac Diethylamine

PubMed Central

Mulgund, S. V.; Phoujdar, M. S.; Londhe, S. V.; Mallade, P. S.; Kulkarni, T. S.; Deshpande, A. S.; Jain, K. S.

2009-01-01

A simple, specific, accurate and stability-indicating reversed phase high performance liquid chromatographic method was developed for the simultaneous determination of mephenesin and diclofenac diethylamine, using a Spheri-5-RP-18 column and a mobile phase composed of methanol: water (70:30, v/v), pH 3.0 adjusted with o-phosphoric acid. The retention times of mephenesin and diclofenac diethylamine were found to be 3.9 min and 14.5 min, respectively. Linearity was established for mephenesin and diclofenac diethylamine in the range of 50-300 μg/ml and 10-60 μg/ml, respectively. The percentage recoveries of mephenesin and diclofenac diethylamine were found to be in the range of 99.06-100.60% and 98.95-99.98%, respectively. Both the drugs were subjected to acid, alkali and neutral hydrolysis, oxidation, dry heat, photolytic and UV degradation. The degradation studies indicated, mephenesin to be susceptible to neutral hydrolysis, while diclofenac diethylamine showed degradation in acid, H2O2, photolytic and in presence of UV radiation. The degradation products of diclofenac diethylamine in acidic and photolytic conditions were well resolved from the pure drug with significant differences in their retention time values. This method can be successfully employed for simultaneous quantitative analysis of mephenesin and diclofenac diethylamine in bulk drugs and formulations. PMID:20177453

The Functional Arm Scale for Throwers (FAST)-Part II: Reliability and Validity of an Upper Extremity Region-Specific and Population-Specific Patient-Reported Outcome Scale for Throwing Athletes.

PubMed

Huxel Bliven, Kellie C; Snyder Valier, Alison R; Bay, R Curtis; Sauers, Eric L

2017-04-01

.49-0.82) and KJOC (ICC, 0.62-0.81) scores. The FAST total score classified 85.1% of players into the correct injury group. For predicting UE injury status, a FAST total cutoff score of 10.0 out of 100.0 was 91% sensitive and 75% specific, and a pitcher module score of 10.0 out of 100.0 was 87% sensitive and 78% specific. The FAST total score demonstrated responsiveness on several indices between intake and discharge time points. The FAST is a reliable, valid, and responsive UE region-specific and population-specific PRO scale for measuring patient-reported health care outcomes in throwing athletes with injury.

Validation of maternal reports for low birthweight and preterm birth indicators in rural Nepal.

PubMed

Chang, Karen T; Mullany, Luke C; Khatry, Subarna K; LeClerq, Steven C; Munos, Melinda K; Katz, Joanne

2018-06-01

Tracking progress towards global newborn health targets depends largely on maternal reported data collected through large, nationally representative surveys. We evaluated the validity, across a range of recall period lengths (1 to 24 months post-delivery), of maternal report of birthweight, birth size and length of pregnancy. We compared maternal reports to reference standards of birthweights measured within 72 hours of delivery and gestational age generated from reported first day of the last menstrual period (LMP) prospectively collected as part of a population-based study (n = 1502). We calculated sensitivity, specificity, area the under the receiver operating curve (AUC) as a measure of individual-level accuracy, and the inflation factor (IF) to quantify population-level bias for each indicator. We assessed if length of recall period modified accuracy by stratifying measurements across time bins and using a modified Poisson regression with robust error variance to estimate the relative risk (RR) of correctly classifying newborns as low birthweight (LBW) or preterm, adjusting for child sex, place of delivery, maternal age, maternal education, parity, and ethnicity. The LBW indicator using maternally reported birthweight in grams had low individual-level accuracy (AUC = 0.69) and high population-level bias (inflation factor IF = 0.62). LBW using maternally reported birth size and the preterm birth indicator had lower individual-level accuracy (AUC = 0.58 and 0.56, respectively) and higher population-level bias (IF = 0.28 and 0.35, respectively) up to 24 months following birth. Length of recall time did not affect accuracy of LBW indicators. For the preterm birth indicator, accuracy did not change with length of recall up to 20 months after birth and improved slightly beyond 20 months. The use of maternal reports may underestimate and bias indicators for LBW and preterm birth. In settings with high prevalence of LBW and preterm births, these

Further examination of embedded performance validity indicators for the Conners' Continuous Performance Test and Brief Test of Attention in a large outpatient clinical sample.

PubMed

Sharland, Michael J; Waring, Stephen C; Johnson, Brian P; Taran, Allise M; Rusin, Travis A; Pattock, Andrew M; Palcher, Jeanette A

2018-01-01

Assessing test performance validity is a standard clinical practice and although studies have examined the utility of cognitive/memory measures, few have examined attention measures as indicators of performance validity beyond the Reliable Digit Span. The current study further investigates the classification probability of embedded Performance Validity Tests (PVTs) within the Brief Test of Attention (BTA) and the Conners' Continuous Performance Test (CPT-II), in a large clinical sample. This was a retrospective study of 615 patients consecutively referred for comprehensive outpatient neuropsychological evaluation. Non-credible performance was defined two ways: failure on one or more PVTs and failure on two or more PVTs. Classification probability of the BTA and CPT-II into non-credible groups was assessed. Sensitivity, specificity, positive predictive value, and negative predictive value were derived to identify clinically relevant cut-off scores. When using failure on two or more PVTs as the indicator for non-credible responding compared to failure on one or more PVTs, highest classification probability, or area under the curve (AUC), was achieved by the BTA (AUC = .87 vs. .79). CPT-II Omission, Commission, and Total Errors exhibited higher classification probability as well. Overall, these findings corroborate previous findings, extending them to a large clinical sample. BTA and CPT-II are useful embedded performance validity indicators within a clinical battery but should not be used in isolation without other performance validity indicators.

English translation and validation of the SarQoL®, a quality of life questionnaire specific for sarcopenia.

PubMed

Beaudart, Charlotte; Edwards, Mark; Moss, Charlotte; Reginster, Jean-Yves; Moon, Rebecca; Parsons, Camille; Demoulin, Christophe; Rizzoli, René; Biver, Emmanuel; Dennison, Elaine; Bruyere, Olivier; Cooper, Cyrus

2017-03-01

the first quality of life questionnaire specific to sarcopenia, the SarQoL®, has recently been developed and validated in French. To extend the availability and utilisation of this questionnaire, its translation and validation in other languages is necessary. the purpose of this study was therefore to translate the SarQoL® into English and validate the psychometric properties of this new version. cross-sectional. Hertfordshire, UK. in total, 404 participants of the Hertfordshire Cohort Study, UK. the translation part was articulated in five stages: (i) two initial translations from French to English; (ii) synthesis of the two translations; (iii) backward translations; (iv) expert committee to compare the backward translations with the original questionnaire and (v) pre-test. To validate the English SarQoL®, we assessed its validity (discriminative power, construct validity), reliability (internal consistency, test-retest reliability) and floor/ceiling effects. the SarQoL® questionnaire was translated without any major difficulties. Results indicated a good discriminative power (lower score of quality of life for sarcopenic subjects, P = 0.01), high internal consistency (Cronbach's alpha of 0.88), consistent construct validity (high correlations found with domains related to mobility, usual activities, vitality, physical function and low correlations with domains related to anxiety, self-care, mental health and social problems) and excellent test-retest reliability (intraclass coefficient correlation of 0.95, 95%CI 0.92-0.97). Moreover, no floor/ceiling has been found. a valid SarQoL® English questionnaire is now available and can be used with confidence to better assess the disease burden associated with sarcopenia. It could also be used as a treatment outcome indicator in research. © The Author 2016. Published by Oxford University Press on behalf of the British Geriatrics Society.

Development and Validation of a Novel Robotic Procedure Specific Simulation Platform: Partial Nephrectomy.

PubMed

Hung, Andrew J; Shah, Swar H; Dalag, Leonard; Shin, Daniel; Gill, Inderbir S

2015-08-01

We developed a novel procedure specific simulation platform for robotic partial nephrectomy. In this study we prospectively evaluate its face, content, construct and concurrent validity. This hybrid platform features augmented reality and virtual reality. Augmented reality involves 3-dimensional robotic partial nephrectomy surgical videos overlaid with virtual instruments to teach surgical anatomy, technical skills and operative steps. Advanced technical skills are assessed with an embedded full virtual reality renorrhaphy task. Participants were classified as novice (no surgical training, 15), intermediate (less than 100 robotic cases, 13) or expert (100 or more robotic cases, 14) and prospectively assessed. Cohort performance was compared with the Kruskal-Wallis test (construct validity). Post-study questionnaire was used to assess the realism of simulation (face validity) and usefulness for training (content validity). Concurrent validity evaluated correlation between virtual reality renorrhaphy task and a live porcine robotic partial nephrectomy performance (Spearman's analysis). Experts rated the augmented reality content as realistic (median 8/10) and helpful for resident/fellow training (8.0-8.2/10). Experts rated the platform highly for teaching anatomy (9/10) and operative steps (8.5/10) but moderately for technical skills (7.5/10). Experts and intermediates outperformed novices (construct validity) in efficiency (p=0.0002) and accuracy (p=0.002). For virtual reality renorrhaphy, experts outperformed intermediates on GEARS metrics (p=0.002). Virtual reality renorrhaphy and in vivo porcine robotic partial nephrectomy performance correlated significantly (r=0.8, p <0.0001) (concurrent validity). This augmented reality simulation platform displayed face, content and construct validity. Performance in the procedure specific virtual reality task correlated highly with a porcine model (concurrent validity). Future efforts will integrate procedure specific

Stability-indicating method for simultaneous estimation of olmesartan medoxomile, amlodipine besylate and hydrochlorothiazide by RP-HPLC in tablet dosage form.

PubMed

Jain, P S; Patel, M K; Gorle, A P; Chaudhari, A J; Surana, S J

2012-09-01

A simple, specific, accurate and precise stability-indicating reversed-phase high-performance liquid chromatographic method was developed for simultaneous estimation of olmesartan medoxomile (OLME), amlodipine besylate (AMLO) and hydrochlorothiazide (HCTZ) in tablet dosage form. The method was developed using an RP C18 base deactivated silica column (250 × 4.6 mm, 5 µm) with a mobile phase consisting of triethylamine (pH 3.0) adjusted with orthophosphoric acid (A) and acetonitrile (B), with a timed gradient program of T/%B: 0/30, 7/70, 8/30, 10/30 with a flow rate of 1.4 mL/min. Ultraviolet detection was used at 236 nm. The retention times for OLME, AMLO and HCTZ were found to be 6.72, 4.28 and 2.30, respectively. The proposed method was validated for precision, accuracy, linearity, range, robustness, ruggedness and force degradation study. The calibration curves of OLME, AMLO and HCTZ were linear over the range of 50-150, 12.5-37.5 and 31-93 µg/mL, respectively. The method was found to be sensitive. The limits of detection of OLME, AMLO and HCTZ were determined 0.19, 0.16 and 0.22 µg/mL and limits of quantification of OLME, AMLO and HCTZ were determined 0.57, 0.49 and 0.66, respectively. Forced degradation study was performed according to International Conference on Harmonization guidelines.

Stability-Indicating Reversed-Phase UHPLC Method Development and Characterization of Degradation Products of Almotriptan Maleate by LC-QTOF-MS/MS.

PubMed

Saibaba, B; Vishnuvardhan, Ch; Johnsi Rani, P; Satheesh Kumar, N

2018-01-01

Almotriptan maleate (ALMT), a highly selective 5-hydroxy tryptamine 1B/1D (5-HT1B/1D) receptor agonist used in the treatment of migraine headache was subjected to various ICH (Q1A (R2)) specified guidelines. The drug underwent significant degradation under hydrolytic (acid, base and neutral), oxidative and photolytic stress conditions, while it was stable under thermal stress condition. A total of seven significant degradation products (DPs) were obtained. A simple, selective and reliable UPLC method has been developed for the separation of ALMT and its DPs using Acquity UPLC HSS Cyano (100 × 2.1 mm, 1.8 μm) column with mobile phase consisting of ammonium acetate (10 mM, pH 4.4) buffer and acetonitrile in gradient elution mode. Chromatographic analysis was performed at a flow rate of 0.3 mL/min using a PDA detector at a wavelength of 230 nm. All the DPs (DP-1 to DP-7) were characterized using UHPLC-ESI-QTOF based on mass fragmentation pattern and accurate m/z values. The developed UPLC method was validated in terms of specificity, linearity, precision and accuracy. The developed stability-indicating method helps in quantification of drug in the presence of DPs. © The Author 2017. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Validation of the World Health Organization Enzyme-Linked Immunosorbent Assay for the Quantitation of Immunoglobulin G Serotype-Specific Anti-Pneumococcal Antibodies in Human Serum.

PubMed

Lee, Hyunju; Lim, Soo Young; Kim, Kyung Hyo

2017-10-01

The World Health Organization (WHO) enzyme-linked immunosorbent assay (ELISA) guideline is currently accepted as the gold standard for the evaluation of immunoglobulin G (IgG) antibodies specific to pneumococcal capsular polysaccharide. We conducted validation of the WHO ELISA for 7 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, and 23F) by evaluating its specificity, precision (reproducibility and intermediate precision), accuracy, spiking recovery test, lower limit of quantification (LLOQ), and stability at the Ewha Center for Vaccine Evaluation and Study, Seoul, Korea. We found that the specificity, reproducibility, and intermediate precision were within acceptance ranges (reproducibility, coefficient of variability [CV] ≤ 15%; intermediate precision, CV ≤ 20%) for all serotypes. Comparisons between the provisional assignments of calibration sera and the results from this laboratory showed a high correlation > 94% for all 7 serotypes, supporting the accuracy of the ELISA. The spiking recovery test also fell within an acceptable range. The quantification limit, calculated using the LLOQ, for each of the serotypes was 0.05-0.093 μg/mL. The freeze-thaw stability and the short-term temperature stability were also within an acceptable range. In conclusion, we showed good performance using the standardized WHO ELISA for the evaluation of serotype-specific anti-pneumococcal IgG antibodies; the WHO ELISA can evaluate the immune response against pneumococcal vaccines with consistency and accuracy. © 2017 The Korean Academy of Medical Sciences.

Validity of the Indicator Organism Paradigm for Pathogen Reduction in Reclaimed Water and Public Health Protection†

PubMed Central

Harwood, Valerie J.; Levine, Audrey D.; Scott, Troy M.; Chivukula, Vasanta; Lukasik, Jerzy; Farrah, Samuel R.; Rose, Joan B.

2005-01-01

The validity of using indicator organisms (total and fecal coliforms, enterococci, Clostridium perfringens, and F-specific coliphages) to predict the presence or absence of pathogens (infectious enteric viruses, Cryptosporidium, and Giardia) was tested at six wastewater reclamation facilities. Multiple samplings conducted at each facility over a 1-year period. Larger sample volumes for indicators (0.2 to 0.4 liters) and pathogens (30 to 100 liters) resulted in more sensitive detection limits than are typical of routine monitoring. Microorganisms were detected in disinfected effluent samples at the following frequencies: total coliforms, 63%; fecal coliforms, 27%; enterococci, 27%; C. perfringens, 61%; F-specific coliphages, ∼40%; and enteric viruses, 31%. Cryptosporidium oocysts and Giardia cysts were detected in 70% and 80%, respectively, of reclaimed water samples. Viable Cryptosporidium, based on cell culture infectivity assays, was detected in 20% of the reclaimed water samples. No strong correlation was found for any indicator-pathogen combination. When data for all indicators were tested using discriminant analysis, the presence/absence patterns for Giardia cysts, Cryptosporidium oocysts, infectious Cryptosporidium, and infectious enteric viruses were predicted for over 71% of disinfected effluents. The failure of measurements of single indicator organism to correlate with pathogens suggests that public health is not adequately protected by simple monitoring schemes based on detection of a single indicator, particularly at the detection limits routinely employed. Monitoring a suite of indicator organisms in reclaimed effluent is more likely to be predictive of the presence of certain pathogens, and a need for additional pathogen monitoring in reclaimed water in order to protect public health is suggested by this study. PMID:15933017

[Reliability and validity of depression scales of Chinese version: a systematic review].

PubMed

Sun, X Y; Li, Y X; Yu, C Q; Li, L M

2017-01-10

Objective: Through systematically reviewing the reliability and validity of depression scales of Chinese version in adults in China to evaluate the psychometric properties of depression scales for different groups. Methods: Eligible studies published before 6 May 2016 were retrieved from the following database: CNKI, Wanfang, PubMed and Embase. The HSROC model of the diagnostic test accuracy (DTA) for Meta-analysis was used to calculate the pooled sensitivity and specificity of the PHQ-9. Results: A total of 44 papers evaluating the performance of depression scales were included. Results showed that the reliability and validity of the common depression scales were eligible, including the Beck depression inventory (BDI), the Hamilton depression scale (HAMD), the center epidemiological studies depression scale (CES-D), the patient health questionnaire (PHQ) and the Geriatric depression scale (GDS). The Cronbach' s coefficient of most tools were larger than 0.8, while the test-retest reliability and split-half reliability were larger than 0.7, indicating good internal consistency and stability. The criterion validity, convergent validity, discrimination validity and screening validity were acceptable though different cut-off points were recommended by different studies. The pooled sensitivity of the 11 studies evaluating PHQ-9 was 0.88 (95 %CI : 0.85-0.91) while the pooled specificity was 0.89 (95 %CI : 0.82-0.94), which demonstrated the applicability of PHQ-9 in screening depression. Conclusion: The reliability and validity of different depression scales of Chinese version are acceptable. The characteristics of different tools and study population should be taken into consideration when choosing a specific scale.

[Validity of indicators on physical activity and sedentary behavior from the Brazilian National School-Based Health Survey among adolescents in Rio de Janeiro, Brazil].

PubMed

Tavares, Letícia Ferreira; Castro, Inês Rugani Ribeiro de; Cardoso, Letícia Oliveira; Levy, Renata Bertazzi; Claro, Rafael Moreira; Oliveira, Andreia Ferreira de

2014-09-01

This study evaluated the relative validity of physical activity indicators from the questionnaire used in the Brazilian National School-Based Health Survey (PeNSE) in the city of Rio de Janeiro, Brazil, based on a sample of 174 students. The following indicators of weekly physical activity were evaluated: ACTIVE-300MIN (≥ 300 minutes/week); ACTIVE-150MIN (≥ 150 minutes), INACTIVE (no physical activity). Additionally, indicators of sedentary behavior were also assessed, as daily screen time (TV, videogames, and computer). The results from the questionnaire were compared with three 24-hour recalls. The results of ACTIVE-300MIN, ACTIVE-150MIN, and INACTIVE generated by PeNSE showed high accuracy. These indicators performed better than those of sedentary behavior in relation to frequency estimates as well as sensitivity, specificity, and correct classification rate. The indicators of physical activity from PeNSE showed satisfactory relative validity.

Synchrophasor-Assisted Prediction of Stability/Instability of a Power System

NASA Astrophysics Data System (ADS)

Saha Roy, Biman Kumar; Sinha, Avinash Kumar; Pradhan, Ashok Kumar

2013-05-01

This paper presents a technique for real-time prediction of stability/instability of a power system based on synchrophasor measurements obtained from phasor measurement units (PMUs) at generator buses. For stability assessment the technique makes use of system severity indices developed using bus voltage magnitude obtained from PMUs and generator electrical power. Generator power is computed using system information and PMU information like voltage and current phasors obtained from PMU. System stability/instability is predicted when the indices exceeds a threshold value. A case study is carried out on New England 10-generator, 39-bus system to validate the performance of the technique.

Quality assurance and stability reference (QUASAR) monitoring concept for calibration/validation

NASA Astrophysics Data System (ADS)

Teillet, Philippe M.; Horler, D. N.; O'Neill, Norman T.

1997-12-01

The paper introduces the concept that calibration/validation (cal/val) can play an essential role in bringing remote sensing to mainstream consumers in an information-based society, provided that cal/val is an integral part of a quality-assurance strategy. A market model for remote sensing is introduced and used to demonstrate that quality assurance is the key to bridging the gap between early adopters of technology and mainstream markets. The paper goes on to propose the semi-continuous monitoring of quality assurance and stability reference (QUASAR) sites as an important first step towards a cal/val infrastructure beneficial to mainstream users. Prospective QUASAR test sites are described.

The Functional Arm Scale for Throwers (FAST)—Part II: Reliability and Validity of an Upper Extremity Region-Specific and Population-Specific Patient-Reported Outcome Scale for Throwing Athletes

PubMed Central

Huxel Bliven, Kellie C.; Snyder Valier, Alison R.; Bay, R. Curtis; Sauers, Eric L.

2017-01-01

showed acceptable correlation with DASH (ICC, 0.49-0.82) and KJOC (ICC, 0.62-0.81) scores. The FAST total score classified 85.1% of players into the correct injury group. For predicting UE injury status, a FAST total cutoff score of 10.0 out of 100.0 was 91% sensitive and 75% specific, and a pitcher module score of 10.0 out of 100.0 was 87% sensitive and 78% specific. The FAST total score demonstrated responsiveness on several indices between intake and discharge time points. Conclusion: The FAST is a reliable, valid, and responsive UE region-specific and population-specific PRO scale for measuring patient-reported health care outcomes in throwing athletes with injury. PMID:28451614

2013 Early Career Achievement Award--Proteomics of muscle- and species-specificity in meat color stability.

PubMed

Suman, S P; Rentfrow, G; Nair, M N; Joseph, P

2014-03-01

Meat color is the most important quality trait influencing consumer purchase decisions. The interinfluential interactions between myoglobin and biomolecules govern color stability in meat. The advances in proteomics, such as high throughput analytical tools in mass spectrometry, 2-dimensional electrophoresis, and bioinformatics, offer themselves as robust techniques to characterize the proteome basis of muscle- and species-specific meat color phenomena. Differential abundance of chaperones and antioxidant proteins contributes to muscle-specific color stability in beef; the greater abundance of chaperones and antioxidant proteins in color-stable Longissimus lumborum than in color-labile Psoas major protects myoglobin and contributes to superior color stability of beef Longissimus steaks. Lipid oxidation-induced myoglobin oxidation is more critical to beef color than pork color due to the inherent differences in myoglobin chemistry; the number of nucleophilic histidine residues adducted by reactive aldehydes is greater in beef myoglobin than in pork myoglobin. Preferential adduction of secondary products of lipid oxidation to beef myoglobin accelerates metmyoglobin formation at a greater degree than in its pork counterpart. Mass spectrometric investigations revealed that although cherry-red carboxymyoglobin is more stable than oxymyoglobin, both redox forms undergo lipid oxidation-induced oxidation in model systems. The accuracy of mass spectrometry to detect the molecular mass of proteins has been applied to differentiate myoglobins from closely related meat animals, such as goats and sheep or emu and ostrich. In addition, this approach indicated that turkey myoglobin is 350 Da greater in molecular mass than beef myoglobin, and the unique biochemistry of turkey myoglobin could be responsible for its greater thermostability in model systems as well as the pink color defect observed in fully cooked uncured turkey products.

Validity of maximal isometric knee extension strength measurements obtained via belt-stabilized hand-held dynamometry in healthy adults.

PubMed

Ushiyama, Naoko; Kurobe, Yasushi; Momose, Kimito

2017-11-01

[Purpose] To determine the validity of knee extension muscle strength measurements using belt-stabilized hand-held dynamometry with and without body stabilization compared with the gold standard isokinetic dynamometry in healthy adults. [Subjects and Methods] Twenty-nine healthy adults (mean age, 21.3 years) were included. Study parameters involved right side measurements of maximal isometric knee extension strength obtained using belt-stabilized hand-held dynamometry with and without body stabilization and the gold standard. Measurements were performed in all subjects. [Results] A moderate correlation and fixed bias were found between measurements obtained using belt-stabilized hand-held dynamometry with body stabilization and the gold standard. No significant correlation and proportional bias were found between measurements obtained using belt-stabilized hand-held dynamometry without body stabilization and the gold standard. The strength identified using belt-stabilized hand-held dynamometry with body stabilization may not be commensurate with the maximum strength individuals can generate; however, it reflects such strength. In contrast, the strength identified using belt-stabilized hand-held dynamometry without body stabilization does not reflect the maximum strength. Therefore, a chair should be used to stabilize the body when performing measurements of maximal isometric knee extension strength using belt-stabilized hand-held dynamometry in healthy adults. [Conclusion] Belt-stabilized hand-held dynamometry with body stabilization is more convenient than the gold standard in clinical settings.

A new, rapid, stability-indicating UPLC method for separation and determination of impurities in amlodipine besylate, valsartan and hydrochlorothiazide in their combined tablet dosage form.

PubMed

Vojta, Jiří; Jedlička, Aleš; Coufal, Pavel; Janečková, Lucie

2015-05-10

A new rapid stability-indicating UPLC method for separation and determination of impurities in amlodipine besylate, valsartan and hydrochlorothiazide in their combined tablet dosage form was developed. The separation of Ph. Eur. related substances of amlodipine besylate (A, B, D, E, F, G), hydrochlorothiazide (A, B, C), valsartan (B, C), two other valsartan impurities (S)-2-(N-{[2'-cyanobiphenyl-4-yl]methyl}pentanamido)-3-methylbutanoic acid and (S)-3-methyl-2-{[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methylamino}butanoic acid and several unknown impurities was achieved by reversed phase liquid chromatography with UV detection. The detection wavelengths were set as follows: 225nm for valsartan, its impurities and for the impurity D of amlodipine, 271nm for hydrochlorothiazide and its impurities and 360nm for amlodipine and its impurities except for impurity D. Zorbax Eclipse C8 RRHD (100mm×3.0mm, 1.8μm) was used as a separation column and the analytes were eluted within 11min by a programmed gradient mixture of 0.01M phosphate buffer pH 2.5 and acetonitrile. The method was successfully validated in accordance to the International Conference of Harmonization (ICH) guidelines for amlodipine besylate and its impurity D, valsartan and its impurity C and hydrochlorothiazide and its impurities A, B and C. The triple-combined tablets were exposed to thermal, higher humidity, acid, alkaline, oxidative and photolytic stress conditions. Stressed samples were analyzed by the proposed method. All the significant degradation products and impurities were satisfactory separated from each other and from the principal peaks of drug substances. The peak purity test complied for peaks of amlodipine, valsartan and hydrochlorothiazide in all the stressed samples and indicated no co-elution of degradation products. The method was found to be precise, linear, accurate, sensitive, specific, robust and stability-indicating and could be used as a routine purity test method for amlodipine

A Stability-Indicating HPLC Method for the Determination of Nitrosylcobalamin (NO-Cbl), a Novel Vitamin B12 Analog.

PubMed

Dunphy, Michael J; Sysel, Annette M; Lupica, Joseph A; Griffith, Kristie; Sherrod, Taylor; Bauer, Joseph A

2014-04-01

Nitrosylcobalamin (NO-Cbl), a novel vitamin B 12 analog and anti-tumor agent, functions as a biologic 'Trojan horse', utilizing the vitamin B 12 transcobalamin II transport protein and cell surface receptor to specifically target cancer cells. a stability-indicating HPLC method was developed for the detection of NO-Cbl during forced degradation studies. This method utilized an ascentis ® RP-amide (150 mm × 4.6 mm, 5 μm) column at 35 °C with a mobile phase (1.0 mL min -1 ) combining a gradient of methanol and an acetate buffer at pH 6.0. Detection wavelengths of 450 and 254 nm were used to detect corrin and non-corrin-based products, respectively. NO-Cbl, synthesized from hydroxocobalamin and pure nitric oxide gas, was subjected to degradative stress conditions including oxidation, hydrolysis and thermal and radiant energy challenge. The method was validated by assessing linearity, accuracy, precision, detection and quantitation limits and robustness. The method was applied successfully for purity assessment of synthesized NO-Cbl and for the determination of NO-Cbl during kinetic studies in aqueous solution and in solid-state degradation assessments. This HPLC method is suitable for the separation of cobalamins in aqueous and methanolic solutions, for routine detection of NO-Cbl and for purity assessment of synthesized NO-Cbl. additionally, this method has potential application in identification and monitoring of diseases involving altered nitric oxide homeostasis where vitamin B 12 therapy is utilized to scavenge excess nitric oxide, subsequently resulting in the in vivo production of NO-Cbl.

A Stability-Indicating HPLC Method for the Determination of Nitrosylcobalamin (NO-Cbl), a Novel Vitamin B12 Analog

PubMed Central

Dunphy, Michael J.; Sysel, Annette M.; Lupica, Joseph A.; Griffith, Kristie; Sherrod, Taylor

2014-01-01

Nitrosylcobalamin (NO-Cbl), a novel vitamin B12 analog and anti-tumor agent, functions as a biologic ‘Trojan horse’, utilizing the vitamin B12 transcobalamin II transport protein and cell surface receptor to specifically target cancer cells. a stability-indicating HPLC method was developed for the detection of NO-Cbl during forced degradation studies. This method utilized an ascentis® RP-amide (150 mm × 4.6 mm, 5 μm) column at 35 °C with a mobile phase (1.0 mL min−1) combining a gradient of methanol and an acetate buffer at pH 6.0. Detection wavelengths of 450 and 254 nm were used to detect corrin and non-corrin-based products, respectively. NO-Cbl, synthesized from hydroxocobalamin and pure nitric oxide gas, was subjected to degradative stress conditions including oxidation, hydrolysis and thermal and radiant energy challenge. The method was validated by assessing linearity, accuracy, precision, detection and quantitation limits and robustness. The method was applied successfully for purity assessment of synthesized NO-Cbl and for the determination of NO-Cbl during kinetic studies in aqueous solution and in solid-state degradation assessments. This HPLC method is suitable for the separation of cobalamins in aqueous and methanolic solutions, for routine detection of NO-Cbl and for purity assessment of synthesized NO-Cbl. additionally, this method has potential application in identification and monitoring of diseases involving altered nitric oxide homeostasis where vitamin B12 therapy is utilized to scavenge excess nitric oxide, subsequently resulting in the in vivo production of NO-Cbl. PMID:24855323

Evaluating the validity of using unverified indices of body condition

USGS Publications Warehouse

Schamber, J.L.; Esler, Daniel N.; Flint, Paul L.

2009-01-01

Condition indices are commonly used in an attempt to link body condition of birds to ecological variables of interest, including demographic attributes such as survival and reproduction. Most indices are based on body mass adjusted for structural body size, calculated as simple ratios or residuals from regressions. However, condition indices are often applied without confirming their predictive value (i.e., without being validated against measured values of fat and protein), which we term ‘unverified’ use. We evaluated the ability of a number of unverified indices frequently found in the literature to predict absolute and proportional levels of fat and protein across five species of waterfowl. Among indices we considered, those accounting for body size never predicted absolute protein more precisely than body mass, however, some indices improved predictability of fat, although the form of the best index varied by species. Further, the gain in precision by using a condition index to predict either absolute or percent fat was minimal (rise in r2≤0.13), and in many cases model fit was actually reduced. Our data agrees with previous assertions that the assumption that indices provide more precise indicators of body condition than body mass alone is often invalid. We strongly discourage the use of unverified indices, because subjectively selecting indices likely does little to improve precision and might in fact decrease predictability relative to using body mass alone.

Stability of florfenicol in drinking water.

PubMed

Hayes, John M; Eichman, Jonathan; Katz, Terry; Gilewicz, Rosalia

2003-01-01

Florfenicol, a broad-spectrum antibiotic, is being developed for veterinary application as an oral concentrate intended for dilution with drinking water. When a drug product is dosed via drinking water in a farm setting, a number of variables, including pH, chlorine content, hardness of the water used for dilution, and container material, may affect its stability, leading to a decrease in drug potency. The stability of florfenicol after dilution of Florfenicol Drinking Water Concentrate Oral Solution, 23 mg/mL, with drinking water was studied. A stability-indicating, validated liquid chromatographic method was used to evaluate florfenicol stability at 25 degrees C at 5, 10, and 24 h after dilution. The results indicate that florfenicol is stable under a range of simulated field conditions, including various pipe materials and conditions of hard or soft and chlorinated or nonchlorinated water at low or high pH. Significant degradation (> 10%) was observed only for isolated combinations in galvanized pipes. Analysis indicated that the florfenicol concentration in 8 of the 12 water samples stored in galvanized pipes remained above 90% of the initial concentration (100 mg/L) for 24 h after dilution.

Child pornography offenses are a valid diagnostic indicator of pedophilia.

PubMed

Seto, Michael C; Cantor, James M; Blanchard, Ray

2006-08-01

This study investigated whether being charged with a child pornography offense is a valid diagnostic indicator of pedophilia, as represented by an index of phallometrically assessed sexual arousal to children. The sample of 685 male patients was referred between 1995 and 2004 for a sexological assessment of their sexual interests and behavior. As a group, child pornography offenders showed greater sexual arousal to children than to adults and differed from groups of sex offenders against children, sex offenders against adults, and general sexology patients. The results suggest child pornography offending is a stronger diagnostic indicator of pedophilia than is sexually offending against child victims. Theoretical and clinical implications are discussed. Copyright 2006 APA, all rights reserved.

Validation of a condition-specific measure for women having an abnormal screening mammography.

PubMed

Brodersen, John; Thorsen, Hanne; Kreiner, Svend

2007-01-01

The aim of this study is to assess the validity of a new condition-specific instrument measuring psychosocial consequences of abnormal screening mammography (PCQ-DK33). The draft version of the PCQ-DK33 was completed on two occasions by 184 women who had received an abnormal screening mammography and on one occasion by 240 women who had received a normal screening result. Item Response Theories and Classical Test Theories were used to analyze data. Construct validity, concurrent validity, known group validity, objectivity and reliability were established by item analysis examining the fit between item responses and Rasch models. Six dimensions covering anxiety, behavioral impact, sense of dejection, impact on sleep, breast examination, and sexuality were identified. One item belonging to the dejection dimension had uniform differential item functioning. Two items not fitting the Rasch models were retained because of high face validity. A sick leave item added useful information when measuring side effects and socioeconomic consequences of breast cancer screening. Five "poor items" were identified and should be deleted from the final instrument. Preliminary evidence for a valid and reliable condition-specific measure for women having an abnormal screening mammography was established. The measure includes 27 "good" items measuring different attributes of the same overall latent structure-the psychosocial consequences of abnormal screening mammography.

A novel stability-indicating UPLC method development and validation for the determination of seven impurities in various diclofenac pharmaceutical dosage forms.

PubMed

Azougagh, M; Elkarbane, M; Bakhous, K; Issmaili, S; Skalli, A; Iben Moussad, S; Benaji, B

2016-09-01

An innovative simple, fast, precise and accurate ultra-high performance liquid chromatography (UPLC) method was developed for the determination of diclofenac (Dic) along with its impurities including the new dimer impurity in various pharmaceutical dosage forms. An Acquity HSS T3 (C18, 100×2.1mm, 1.8μm) column in gradient mode was used with mobile phase comprising of phosphoric acid, which has a pH value of 2.3 and methanol. The flow rate and the injection volume were set at 0.35ml·min(-1) and 1μl, respectively, and the UV detection was carried out at 254nm by using photodiode array detector. Dic was subjected to stress conditions from acid, base, hydrolytic, thermal, oxidative and photolytic degradation. The new developed method was successfully validated in accordance to the International Conference on Harmonization (ICH) guidelines with respect to specificity, limit of detection, limit of quantitation, precision, linearity, accuracy and robustness. The degradation products were well resolved from main peak and its seven impurities, proving the specificity power of the method. The method showed good linearity with consistent recoveries for Dic content and its impurities. The relative percentage of standard deviation obtained for the repeatability and intermediate precision experiments was less than 3% and LOQ was less than 0.5μg·ml(-1) for all compounds. The new proposed method was found to be accurate, precise, specific, linear and robust. In addition, the method was successfully applied for the assay determination of Dic and its impurities in the several pharmaceutical dosage forms. Copyright © 2016 Académie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.

Measuring cancer-specific child adjustment difficulties: Development and validation of the Children's Oncology Child Adjustment Scale (ChOCs).

PubMed

Burke, Kylie; McCarthy, Maria; Lowe, Cherie; Sanders, Matthew R; Lloyd, Erin; Bowden, Madeleine; Williams, Lauren

2017-03-01

Childhood cancer is associated with child adjustment difficulties including, eating and sleep disturbance, and emotional and other behavioral difficulties. However, there is a lack of validated instruments to measure the specific child adjustment issues associated with pediatric cancer treatments. The aim of this study was to develop and evaluate the reliability and validity of a parent-reported, child adjustment scale. One hundred thirty-two parents from two pediatric oncology centers who had children (aged 2-10 years) diagnosed with cancer completed the newly developed measure and additional measures of child behavior, sleep, diet, and quality of life. Children were more than 4 weeks postdiagnosis and less than 12 months postactive treatment. Factor structure, internal consistency, and construct (convergent) validity analyses were conducted. Principal component analysis revealed five distinct and theoretically coherent factors: Sleep Difficulties, Impact of Child's Illness, Eating Difficulties, Hospital-Related Behavior Difficulties, and General Behavior Difficulties. The final 25-item measure, the Children's Oncology Child Adjustment Scale (ChOCs), demonstrated good internal consistency (α = 0.79-0.91). Validity of the ChOCs was demonstrated by significant correlations between the subscales and measures of corresponding constructs. The ChOCs provides a new measure of child adjustment difficulties designed specifically for pediatric oncology. Preliminary analyses indicate strong theoretical and psychometric properties. Future studies are required to further examine reliability and validity of the scale, including test-retest reliability, discriminant validity, as well as change sensitivity and generalizability across different oncology samples and ages of children. The ChOCs shows promise as a measure of child adjustment relevant for oncology clinical settings and research purposes. © 2016 Wiley Periodicals, Inc.

Development and validation of a mass casualty conceptual model.

PubMed

Culley, Joan M; Effken, Judith A

2010-03-01

To develop and validate a conceptual model that provides a framework for the development and evaluation of information systems for mass casualty events. The model was designed based on extant literature and existing theoretical models. A purposeful sample of 18 experts validated the model. Open-ended questions, as well as a 7-point Likert scale, were used to measure expert consensus on the importance of each construct and its relationship in the model and the usefulness of the model to future research. Computer-mediated applications were used to facilitate a modified Delphi technique through which a panel of experts provided validation for the conceptual model. Rounds of questions continued until consensus was reached, as measured by an interquartile range (no more than 1 scale point for each item); stability (change in the distribution of responses less than 15% between rounds); and percent agreement (70% or greater) for indicator questions. Two rounds of the Delphi process were needed to satisfy the criteria for consensus or stability related to the constructs, relationships, and indicators in the model. The panel reached consensus or sufficient stability to retain all 10 constructs, 9 relationships, and 39 of 44 indicators. Experts viewed the model as useful (mean of 5.3 on a 7-point scale). Validation of the model provides the first step in understanding the context in which mass casualty events take place and identifying variables that impact outcomes of care. This study provides a foundation for understanding the complexity of mass casualty care, the roles that nurses play in mass casualty events, and factors that must be considered in designing and evaluating information-communication systems to support effective triage under these conditions.

Development of a Valid and Reliable Knee Articular Cartilage Condition-Specific Study Methodological Quality Score.

PubMed

Harris, Joshua D; Erickson, Brandon J; Cvetanovich, Gregory L; Abrams, Geoffrey D; McCormick, Frank M; Gupta, Anil K; Verma, Nikhil N; Bach, Bernard R; Cole, Brian J

2014-02-01

Condition-specific questionnaires are important components in evaluation of outcomes of surgical interventions. No condition-specific study methodological quality questionnaire exists for evaluation of outcomes of articular cartilage surgery in the knee. To develop a reliable and valid knee articular cartilage-specific study methodological quality questionnaire. Cross-sectional study. A stepwise, a priori-designed framework was created for development of a novel questionnaire. Relevant items to the topic were identified and extracted from a recent systematic review of 194 investigations of knee articular cartilage surgery. In addition, relevant items from existing generic study methodological quality questionnaires were identified. Items for a preliminary questionnaire were generated. Redundant and irrelevant items were eliminated, and acceptable items modified. The instrument was pretested and items weighed. The instrument, the MARK score (Methodological quality of ARticular cartilage studies of the Knee), was tested for validity (criterion validity) and reliability (inter- and intraobserver). A 19-item, 3-domain MARK score was developed. The 100-point scale score demonstrated face validity (focus group of 8 orthopaedic surgeons) and criterion validity (strong correlation to Cochrane Quality Assessment score and Modified Coleman Methodology Score). Interobserver reliability for the overall score was good (intraclass correlation coefficient [ICC], 0.842), and for all individual items of the MARK score, acceptable to perfect (ICC, 0.70-1.000). Intraobserver reliability ICC assessed over a 3-week interval was strong for 2 reviewers (≥0.90). The MARK score is a valid and reliable knee articular cartilage condition-specific study methodological quality instrument. This condition-specific questionnaire may be used to evaluate the quality of studies reporting outcomes of articular cartilage surgery in the knee.

Validation of a rapid conductimetric test for the measurement of wine tartaric stability.

PubMed

Bosso, Antonella; Motta, Silvia; Petrozziello, Maurizio; Guaita, Massimo; Asproudi, Andriani; Panero, Loretta

2016-12-01

This work was aimed at optimizing a rapid and reproducible conductivity test for the evaluation of wine tartaric stability, in order to improve the practices for the prevention of tartaric precipitations during bottle aging. The test consists in measuring the drop of conductivity in wines kept under stirring for a fixed time, at low temperature, after the addition of micronized potassium bitartrate crystals (KHT). An experimental design was planned to study three factors affecting the test: temperature, duration and dose of added potassium bitartrate. A standard protocol was defined to produce a micronized potassium bitartrate starting from available commercial products, since the dimensions of the crystals can affect the final conductivity values. After the choice of the best conditions the method was validated. Two different stability thresholds were defined for white wines and for red/rosé wines by comparing the results of the mini-contact test with those of the cold test. Copyright © 2016 Elsevier Ltd. All rights reserved.

PrimeSupplier Cross-Program Impact Analysis and Supplier Stability Indicator Simulation Model

NASA Technical Reports Server (NTRS)

Calluzzi, Michael

2009-01-01

PrimeSupplier, a supplier cross-program and element-impact simulation model, with supplier solvency indicator (SSI), has been developed so that the shuttle program can see early indicators of supplier and product line stability, while identifying the various elements and/or programs that have a particular supplier or product designed into the system. The model calculates two categories of benchmarks to determine the SSI, with one category focusing on agency programmatic data and the other focusing on a supplier's financial liquidity. PrimeSupplier was developed to help NASA smoothly transition design, manufacturing, and repair operations from the Shuttle program to the Constellation program, without disruption in the industrial supply base.

Drug Target Validation Methods in Malaria - Protein Interference Assay (PIA) as a Tool for Highly Specific Drug Target Validation.

PubMed

Meissner, Kamila A; Lunev, Sergey; Wang, Yuan-Ze; Linzke, Marleen; de Assis Batista, Fernando; Wrenger, Carsten; Groves, Matthew R

2017-01-01

The validation of drug targets in malaria and other human diseases remains a highly difficult and laborious process. In the vast majority of cases, highly specific small molecule tools to inhibit a proteins function in vivo are simply not available. Additionally, the use of genetic tools in the analysis of malarial pathways is challenging. These issues result in difficulties in specifically modulating a hypothetical drug target's function in vivo. The current "toolbox" of various methods and techniques to identify a protein's function in vivo remains very limited and there is a pressing need for expansion. New approaches are urgently required to support target validation in the drug discovery process. Oligomerisation is the natural assembly of multiple copies of a single protein into one object and this self-assembly is present in more than half of all protein structures. Thus, oligomerisation plays a central role in the generation of functional biomolecules. A key feature of oligomerisation is that the oligomeric interfaces between the individual parts of the final assembly are highly specific. However, these interfaces have not yet been systematically explored or exploited to dissect biochemical pathways in vivo. This mini review will describe the current state of the antimalarial toolset as well as the potentially druggable malarial pathways. A specific focus is drawn to the initial efforts to exploit oligomerisation surfaces in drug target validation. As alternative to the conventional methods, Protein Interference Assay (PIA) can be used for specific distortion of the target protein function and pathway assessment in vivo. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Study of the migration phenomena of specific metals in canned tomato paste before and after opening. Validation of a new quality indicator for opened cans.

PubMed

Raptopoulou, Kalomoira G; Pasias, Ioannis N; Thomaidis, Nikolaos S; Proestos, Charalampos

2014-07-01

A method for the simultaneous determination of Cd-Pb, As-Cu, Cr-Ni and Fe-Mn in canned tomato paste samples by Electrothermal Atomic Absorption Spectrometry was developed and validated. The validation procedure was conducted according to the terms of the European regulation for the official control of contaminants in foods. The validated method was applied for the determination of these metals and metalloids in 13 different tomato paste samples and the results showed that Cd content was higher than the maximum permissible value of 0.050 mg kg(-1) as proposed in European Regulation (EC) No 1881/2006 concerning fresh fruits and vegetables. Furthermore, a new quality indicator was evaluated in order to provide information about tomato paste quality and the appropriate storage time of an opened canned tomato paste. Finally, a migration test was accomplished based on the calculation of mass balance and the comparison of the elemental content in canned tomato paste samples and in aseptic paper pack and it was proved that Fe and Pb were the main metals migrating in tomato paste samples. Copyright © 2014 Elsevier Ltd. All rights reserved.

Evaluating the Validity Indices of the Personality Assessment Inventory-Adolescent Version.

PubMed

Meyer, Justin K; Hong, Sang-Hwang; Morey, Leslie C

2015-08-01

Past research has established strong psychometric properties of several indicators of response distortion on the Personality Assessment Inventory (PAI). However, to date, it has been unclear whether the response distortion indicators of the adolescent version of the PAI (PAI-A) operate in an equally valid manner. The current study sought to examine several response distortion indicators on the PAI-A to determine their relative efficacy at the detection of distorted responding, including both positive distortion and negative distortion. Protocols of 98 college students asked to either overreport or underreport were compared with 98 age-matched individuals sampled from the clinical standardization sample and the community standardization sample, respectively. Comparisons between groups were accomplished through the examination of effect sizes and receiver operating characteristic curves. All indicators demonstrated the ability to distinguish between actual and feigned responding, including several newly developed indicators. This study provides support for the ability of distortion indicators developed for the PAI to also function appropriately on the PAI-A. © The Author(s) 2014.

Validity of food consumption indicators in the Lao context: moving toward cross-cultural standardization.

PubMed

Baumann, Soo Mee; Webb, Patrick; Zeller, Manfred

2013-03-01

Cross-cultural validity of food security indicators is commonly presumed without questioning the suitability of generic indicators in different geographic settings. However, ethnic differences in the perception of and reporting on, food insecurity, as well as variations in consumption patterns, may limit the comparability of results. Although research on correction factors for standardization of food security indicators is in process, so far no universal indicator has been identified. The current paper considers the ability of the Food Consumption Score (FCS) developed by the World Food Programme in southern Africa in 1996 to meet the requirement of local cultural validity in a Laotian context. The analysis is based on research that seeks to identify options for correcting possible biases linked to cultural disparities. Based on the results of a household survey conducted in different agroecological zones of Laos in 2009, the FCS was validated against a benchmark of calorie consumption. Changing the thresholds and excluding small amounts of food items consumed were tested as options to correct for biases caused by cultural disparities. The FCS in its original form underestimates the food insecurity level in the surveyed villages. However, the closeness of fit of the FCS to the benchmark classification improves when small amounts of food items are excluded from the assessment. Further research in different cultural settings is required to generate more insight into the extent to which universal thresholds can be applied to dietary diversity indicators with or without locally determined correction factors such as the exclusion of small amounts of food items.

A bioanalytical HPLC method for coumestrol quantification in skin permeation tests followed by UPLC-QTOF/HDMS stability-indicating method for identification of degradation products.

PubMed

Bianchi, Sara E; Teixeira, Helder F; Kaiser, Samuel; Ortega, George G; Schneider, Paulo Henrique; Bassani, Valquiria L

2016-05-01

Coumestrol is present in several species of the Fabaceae family widely distributed in plants. The estrogenic and antioxidant activities of this molecule show its potential as skin anti-aging agent. These characteristics reveal the interest in developing analytical methodology for permeation studies, as well as to know the stability of coumestrol identifying the major degradation products. Thus, the present study was designed, first, to develop and validate a versatile liquid chromatography (HPLC) method to quantify coumestrol in a hydrogel formulation in different porcine skin layers (stratum corneum, epidermis, and dermis) in permeation tests. In the stability-indicating test coumestrol samples were exposed to stress conditions: temperature, UVC light, oxidative, acid and alkaline media. The degradation products, as well as the constituents extracted from the hydrogel, adhesive tape or skin were not eluted in the retention time of the coumestrol. Hence, the HPLC method showed to be versatile, specific, accurate, precise and robust showing excellent performance for quantifying coumestrol in complex matrices involving skin permeation studies. Coumestrol recovery from porcine ear skin was found to be in the range of 97.07-107.28 μg/mL; the intra-day precision (repeatability) and intermediate precision (inter-day precision), respectively lower than 4.71% and 2.09%. The analysis using ultra-performance liquid chromatography coupled to a quadrupole time-of-flight high definition mass spectrometry detector (UPLC-QTOF/HDMS) suggest the MS fragmentation patterns and the chemical structure of the main degradation products. These results represent new and relevant findings for the development of coumestrol pharmaceutical and cosmetic products. Copyright © 2016 Elsevier B.V. All rights reserved.

The Self-esteem Stability Scale (SESS) for Cross-Sectional Direct Assessment of Self-esteem Stability

PubMed Central

Altmann, Tobias; Roth, Marcus

2018-01-01

Self-esteem stability describes fluctuations in the level of self-esteem experienced by individuals over a brief period of time. In recent decades, self-esteem stability has repeatedly been shown to be an important variable affecting psychological functioning. However, measures of self-esteem stability are few and lacking in validity. In this paper, we present the Self-Esteem Stability Scale (SESS), a unidimensional and very brief scale to directly assess self-esteem stability. In four studies (total N = 826), we describe the development of the SESS and present evidence for its validity with respect to individual outcomes (life satisfaction, neuroticism, and vulnerable narcissism) and dyadic outcomes (relationship satisfaction in self- and partner ratings) through direct comparisons with existing measures. The new SESS proved to be a stronger predictor than the existing scales and had incremental validity over and above self-esteem level. The results also showed that all cross-sectional measures of self-esteem stability were only moderately associated with variability in self-esteem levels assessed longitudinally with multiple administrations of the Rosenberg Self-Esteem Scale. We discuss this validity issue, arguing that direct and indirect assessment approaches measure relevant, yet different aspects of self-esteem stability. PMID:29487551

The Self-esteem Stability Scale (SESS) for Cross-Sectional Direct Assessment of Self-esteem Stability.

PubMed

Altmann, Tobias; Roth, Marcus

2018-01-01

Self-esteem stability describes fluctuations in the level of self-esteem experienced by individuals over a brief period of time. In recent decades, self-esteem stability has repeatedly been shown to be an important variable affecting psychological functioning. However, measures of self-esteem stability are few and lacking in validity. In this paper, we present the Self-Esteem Stability Scale (SESS), a unidimensional and very brief scale to directly assess self-esteem stability. In four studies (total N = 826), we describe the development of the SESS and present evidence for its validity with respect to individual outcomes (life satisfaction, neuroticism, and vulnerable narcissism) and dyadic outcomes (relationship satisfaction in self- and partner ratings) through direct comparisons with existing measures. The new SESS proved to be a stronger predictor than the existing scales and had incremental validity over and above self-esteem level. The results also showed that all cross-sectional measures of self-esteem stability were only moderately associated with variability in self-esteem levels assessed longitudinally with multiple administrations of the Rosenberg Self-Esteem Scale. We discuss this validity issue, arguing that direct and indirect assessment approaches measure relevant, yet different aspects of self-esteem stability.

Aggregate stability as an indicator of soil erodibility and soil physical quality: review and perspectives

NASA Astrophysics Data System (ADS)

Le Bissonnais, Yves; Chenu, Claire; Darboux, Frédéric; Duval, Odile; Legout, Cédric; Leguédois, Sophie; Gumiere, Silvio

2010-05-01

Aggregate breakdown due to water and rain action may cause surface crusting, slumping, a reduction of infiltration and interrill erosion. Aggregate stability determines the capacity of aggregates to resist the effects of water and rainfall. In this paper, we evaluated and reviewed the relevance of an aggregate stability measurement to characterize soil physical properties as well as to analyse the processes involved in these properties. Stability measurement assesses the sensitivity of soil aggregates to various basic disaggregation mechanisms such as slaking, differential swelling, dispersion and mechanical breakdown. It has been showed that aggregate size distributions of structural stability tests matched the size distributions of eroded aggregates under rainfall simulations and that erosion amount was well predicted using aggregate stability indexes. It means stability tests could be used to estimate both the erodibility and the size fractions that are available for crust formation and erosion processes. Several studies showed that organic matter was one of the main soil properties affecting soil stability. However, it has also been showed that aggregate stability of a given soil could vary within a year or between years. The factors controlling such changes have still to be specified. Aggregate stability appears therefore as a complex property, depending both on permanent soil characteristics and on dynamic factors such as the crusting stage, the climate and the biological activity. Despite, and may be, because of this complexity, aggregate stability seems an integrative and powerful indicator of soil physical quality. Future research efforts should look at the causes of short-term changes of structural stability, in order to fully understand all its aspects.

Least-Squares Regression and Spectral Residual Augmented Classical Least-Squares Chemometric Models for Stability-Indicating Analysis of Agomelatine and Its Degradation Products: A Comparative Study.

PubMed

Naguib, Ibrahim A; Abdelrahman, Maha M; El Ghobashy, Mohamed R; Ali, Nesma A

2016-01-01

Two accurate, sensitive, and selective stability-indicating methods are developed and validated for simultaneous quantitative determination of agomelatine (AGM) and its forced degradation products (Deg I and Deg II), whether in pure forms or in pharmaceutical formulations. Partial least-squares regression (PLSR) and spectral residual augmented classical least-squares (SRACLS) are two chemometric models that are being subjected to a comparative study through handling UV spectral data in range (215-350 nm). For proper analysis, a three-factor, four-level experimental design was established, resulting in a training set consisting of 16 mixtures containing different ratios of interfering species. An independent test set consisting of eight mixtures was used to validate the prediction ability of the suggested models. The results presented indicate the ability of mentioned multivariate calibration models to analyze AGM, Deg I, and Deg II with high selectivity and accuracy. The analysis results of the pharmaceutical formulations were statistically compared to the reference HPLC method, with no significant differences observed regarding accuracy and precision. The SRACLS model gives comparable results to the PLSR model; however, it keeps the qualitative spectral information of the classical least-squares algorithm for analyzed components.

Stability-indicating spectrophotometric methods for determination of the anticoagulant drug apixaban in the presence of its hydrolytic degradation product

NASA Astrophysics Data System (ADS)

Tantawy, Mahmoud A.; El-Ragehy, Nariman A.; Hassan, Nagiba Y.; Abdelkawy, Mohamed

2016-04-01

Apixaban (a novel anticoagulant agent) was subjected to a stress stability study including acid, alkali, oxidative, photolytic, and thermal degradation. The drug was found to be only liable to acidic and alkaline hydrolysis. The degradation product was then isolated and identified by IR and GC-mass spectrometry. Four spectrophotometric methods, namely; first derivative (D1), derivative ratio (DR), ratio difference (RD) and mean centering of ratio spectra (MCR), have been suggested for the determination of apixaban in presence of its hydrolytic degradation product. The proposed methods do not require any preliminary separation step. The accuracy, precision and linearity ranges of the proposed methods were determined, and the methods were validated as per ICH guidelines and the specificity was assessed by analyzing synthetic mixtures containing different percentages of the degradation product with the drug. The developed methods were successfully applied for the determination of apixaban in bulk powder and its tablet dosage form.

Stability-indicating spectrophotometric methods for determination of the anticoagulant drug apixaban in the presence of its hydrolytic degradation product.

PubMed

Tantawy, Mahmoud A; El-Ragehy, Nariman A; Hassan, Nagiba Y; Abdelkawy, Mohamed

2016-04-15

Apixaban (a novel anticoagulant agent) was subjected to a stress stability study including acid, alkali, oxidative, photolytic, and thermal degradation. The drug was found to be only liable to acidic and alkaline hydrolysis. The degradation product was then isolated and identified by IR and GC-mass spectrometry. Four spectrophotometric methods, namely; first derivative (D(1)), derivative ratio (DR), ratio difference (RD) and mean centering of ratio spectra (MCR), have been suggested for the determination of apixaban in presence of its hydrolytic degradation product. The proposed methods do not require any preliminary separation step. The accuracy, precision and linearity ranges of the proposed methods were determined, and the methods were validated as per ICH guidelines and the specificity was assessed by analyzing synthetic mixtures containing different percentages of the degradation product with the drug. The developed methods were successfully applied for the determination of apixaban in bulk powder and its tablet dosage form. Copyright © 2016 Elsevier B.V. All rights reserved.

Spanish adaptation and validation of the supportive & palliative care indicators tool - SPICT-ESTM.

PubMed

Fachado, Alfonso Alonso; Martínez, Noemí Sansó; Roselló, Marisa Martín; Rial, José Javier Ventosa; Oliver, Enric Benito; García, Rafael Gómez; García, José Manuel Fernández

2018-01-01

OBJECTIVE To culturally adapt and validate the SPICTTM to Spanish, which is a brief and simple tool to support a better identification of chronic patients who have palliative care needs. METHODS For this study, we designed a multicenter and national project between the centers of Galicia, Balearic Islands, and Andalusia. For the process of translation and cross-cultural adaptation of the SPICTTM to Spanish, we followed the steps proposed by Beaton et al. with successive translations and subsequent consensus of experts using the debriefing methodology. After the content validation was completed, the psychometric properties were validated. A prospective longitudinal study was designed with 188 patients from Galicia, the Balearic Islands, and Andalusia. The internal consistency and reliability of the test and retest was analyzed for 10 days by the same researcher. RESULTS For more than 90% of the participants of the SPICT-ESTM, it seems simple to be filled out, and they consider it written in an understandable language. The average time to apply the questionnaire without prior knowledge was 4 minutes and 45 seconds. To evaluate the internal consistency of the instrument, we used the Kuder-Richardson formula 20. Internal consistency is 0.71. The agreement index of the Kappa test is between 0.983 and 0.797 for the different items. CONCLUSIONS In this study, we demonstrate the equivalence of content with the original. In addition, the validation of the psychometric properties establishes that the SPICT-ESTM maintains adequate reliability and stability. If we add the satisfaction shown by the professionals and the ease of use, the SPICT-ESTM is an adequate tool for the identification of palliative patients with chronic diseases and palliative care needs.

Development and Validation of Evaluation Indicators for Teaching Competency in STEAM Education in Korea

ERIC Educational Resources Information Center

Kim, Bang-Hee; Kim, Jinsoo

2016-01-01

The purpose of this study is to develop and validate the evaluation indicators of teaching competency in STEAM education. The teaching competencies in STEAM education were drawn up utilizing both behavioral event interview (BEI) and a literature review. The initial evaluation indicators were then reviewed by 15 experts and two pilot tests were…

Validation of predictive rules and indices of severity for community acquired pneumonia

PubMed Central

Ewig, S; de Roux, A; Bauer, T; Garcia, E; Mensa, J; Niederman, M; Torres, A

2004-01-01

Background: A study was undertaken to validate the modified American Thoracic Society (ATS) rule and two British Thoracic Society (BTS) rules for the prediction of ICU admission and mortality of community acquired pneumonia and to provide a validation of these predictions on the basis of the pneumonia severity index (PSI). Method: Six hundred and ninety six consecutive patients (457 men (66%), mean (SD) age 67.8 (17.1) years, range 18–101) admitted to a tertiary care hospital were studied prospectively. Of these, 116 (16.7%) were admitted to the ICU. Results: The modified ATS rule achieved a sensitivity of 69% (95% CI 50.7 to 77.2), specificity of 97% (95% CI 96.4 to 98.9), positive predictive value of 87% (95% CI 78.3 to 93.1), and negative predictive value of 94% (95% CI 91.8 to 95.8) in predicting admission to the ICU. The corresponding predictive indices for mortality were 94% (95% CI 82.5 to 98.7), 93% (95% CI 90.6 to 94.7), 49% (95% CI 38.2 to 59.7), and 99.5% (95% CI 98.5 to 99.9), respectively. These figures compared favourably with both the BTS rules. The BTS-CURB criteria achieved predictions of pneumonia severity and mortality comparable to the PSI. Conclusions: This study confirms the power of the modified ATS rule to predict severe pneumonia in individual patients. It may be incorporated into current guidelines for the assessment of pneumonia severity. The CURB criteria may be used as an alternative tool to PSI for the detection of low risk patients. PMID:15115872

Development and validation of a Spanish diabetes-specific numeracy measure: DNT-15 Latino.

PubMed

White, Richard O; Osborn, Chandra Y; Gebretsadik, Tebeb; Kripalani, Sunil; Rothman, Russell L

2011-09-01

Although deficits in health literacy and numeracy have been described among Latinos, the impact of low numeracy on diabetes outcomes has not been studied. Study objectives were (1) to establish the reliability and validity of a 15-item Spanish, diabetes-specific numeracy measure (Diabetes Numeracy Test [DNT]-15 Latino) and (2) to examine the relationship between diabetes-specific numeracy and diabetes-related outcomes among a sample of Latino adults with diabetes. Data collection included patient demographics, health literacy, general numeracy, diabetes-specific numeracy, acculturation, self-efficacy, self-care behaviors, and most recent glycosylated hemoglobin (HbA1c). Participants (n=144) were on average 47.8 years old (SD=12.1). The majority were female (62%), uninsured (81%), and of Mexican nationality (78%) and reported low levels of acculturation (96%). The DNT-15 Latino had high internal reliability (Kruder-Richardson 20=0.78). The DNT-15 Latino demonstrated construct validity, correlating with measures of health literacy (ρ=0.291), general numeracy (ρ=0.500), education (ρ=0.361), and income (ρ=0.270) (P<0.001 for each). The DNT-15 Latino was significantly associated with acculturation but unrelated to self-efficacy, self-care behaviors, insulin use, and HbA1c. The DNT-15 Latino is a reliable and valid measure of diabetes-specific numeracy for Latino patients with diabetes; however, additional studies are needed to further explore the association between diabetes-specific numeracy and acculturation and their impact on diabetes-related outcomes for Latinos.

The specification-based validation of reliable multicast protocol: Problem Report. M.S. Thesis

NASA Technical Reports Server (NTRS)

Wu, Yunqing

1995-01-01

Reliable Multicast Protocol (RMP) is a communication protocol that provides an atomic, totally ordered, reliable multicast service on top of unreliable IP multicasting. In this report, we develop formal models for RMP using existing automated verification systems, and perform validation on the formal RMP specifications. The validation analysis help identifies some minor specification and design problems. We also use the formal models of RMP to generate a test suite for conformance testing of the implementation. Throughout the process of RMP development, we follow an iterative, interactive approach that emphasizes concurrent and parallel progress of implementation and verification processes. Through this approach, we incorporate formal techniques into our development process, promote a common understanding for the protocol, increase the reliability of our software, and maintain high fidelity between the specifications of RMP and its implementation.

Advanced aeroservoelastic stabilization techniques for hypersonic flight vehicles

NASA Technical Reports Server (NTRS)

Chan, Samuel Y.; Cheng, Peter Y.; Myers, Thomas T.; Klyde, David H.; Magdaleno, Raymond E.; Mcruer, Duane T.

1992-01-01

Advanced high performance vehicles, including Single-Stage-To-Orbit (SSTO) hypersonic flight vehicles, that are statically unstable, require higher bandwidth flight control systems to compensate for the instability resulting in interactions between the flight control system, the engine/propulsion dynamics, and the low frequency structural modes. Military specifications, such as MIL-F-9490D and MIL-F-87242, tend to limit treatment of structural modes to conventional gain stabilization techniques. The conventional gain stabilization techniques, however, introduce low frequency effective time delays which can be troublesome from a flying qualities standpoint. These time delays can be alleviated by appropriate blending of gain and phase stabilization techniques (referred to as Hybrid Phase Stabilization or HPS) for the low frequency structural modes. The potential of using HPS for compensating structural mode interaction was previously explored. It was shown that effective time delay was significantly reduced with the use of HPS; however, the HPS design was seen to have greater residual response than a conventional gain stablized design. Additional work performed to advance and refine the HPS design procedure, to further develop residual response metrics as a basis for alternative structural stability specifications, and to develop strategies for validating HPS design and specification concepts in manned simulation is presented. Stabilization design sensitivity to structural uncertainties and aircraft-centered requirements are also assessed.

Stability analysis and stabilization strategies for linear supply chains

NASA Astrophysics Data System (ADS)

Nagatani, Takashi; Helbing, Dirk

2004-04-01

Due to delays in the adaptation of production or delivery rates, supply chains can be dynamically unstable with respect to perturbations in the consumption rate, which is known as “bull-whip effect”. Here, we study several conceivable production strategies to stabilize supply chains, which is expressed by different specifications of the management function controlling the production speed in dependence of the stock levels. In particular, we will investigate, whether the reaction to stock levels of other producers or suppliers has a stabilizing effect. We will also demonstrate that the anticipation of future stock levels can stabilize the supply system, given the forecast horizon τ is long enough. To show this, we derive linear stability conditions and carry out simulations for different control strategies. The results indicate that the linear stability analysis is a helpful tool for the judgement of the stabilization effect, although unexpected deviations can occur in the non-linear regime. There are also signs of phase transitions and chaotic behavior, but this remains to be investigated more thoroughly in the future.

A dynamic model for generating actuator specifications for small arms barrel active stabilization

NASA Astrophysics Data System (ADS)

Pathak, Anupam; Brei, Diann; Luntz, Jonathan; Lavigna, Chris

2006-03-01

Due to stresses encountered in combat, it is known that soldier marksmanship noticeably decreases regardless of prior training. Active stabilization systems in small arms have potential to address this problem to increase soldier survivability and mission effectiveness. The key to success is proper actuator design, but this is highly dependent on proper specification which is challenging due to the human/weapon interaction. This paper presents a generic analytical dynamic model which is capable of defining the necessary actuation specifications for a wide range of small arms platforms. The model is unique because it captures the human interface--shoulder and arm--that introduces the jitter disturbance in addition to the geometry, inertial properties and active stabilization stiffness of the small arms platform. Because no data to date is available for actual shooter-induced disturbance in field conditions, a method is given using the model to back-solve from measured shooting range variability data the disturbance amplitude information relative to the input source (arm or shoulder). As examples of the applicability of the model to various small arms systems, two different weapon systems were investigated: the M24 sniper weapon and the M16 assault rifle. In both cases, model based simulations provided valuable insight into impact on the actuation specifications (force, displacement, phase, frequency) due to the interplay of the human-weapon-active stabilization interface including the effect of shooter-disturbance frequency, disturbance location (shoulder vs. arm), and system parameters (stiffness, barrel rotation).

Specific muscle stabilizing as home exercises for persistent pelvic girdle pain after pregnancy: a randomized, controlled clinical trial.

PubMed

Gutke, Annelie; Sjödahl, Jenny; Oberg, Birgitta

2010-11-01

To investigate the efficacy of home-based specific stabilizing exercises focusing on the local stabilizing muscles as the only intervention in the treatment of persistent postpartum pelvic girdle pain. A prospective, randomized, single-blinded, clinically controlled study. Eighty-eight women with pelvic girdle pain were recruited 3 months after delivery. The treatment consisted of specific stabilizing exercises targeting the local trunk muscles. The reference group had a single telephone contact with a physiotherapist. Primary outcome was disability measured with Oswestry Disability Index. Secondary outcomes were pain, health-related quality of life (EQ-5D), symptom satisfaction, and muscle function. No significant differences between groups could be found at 3- or 6-month follow-up regarding primary outcome in disability. Within-group comparisons showed some improvement in both groups in terms of disability, pain, symptom satisfaction and muscle function compared with baseline, although the majority still experienced pelvic girdle pain. Treatment with this home-training concept of specific stabilizing exercises targeting the local muscles was no more effective in improving consequences of persistent postpartum pelvic girdle pain than the clinically natural course. Regardless of whether treatment with specific stabilizing exercises was carried out, the majority of women still experienced some back pain almost one year after pregnancy.

Development of organ-specific donor risk indices.

PubMed

Akkina, Sanjeev K; Asrani, Sumeet K; Peng, Yi; Stock, Peter; Kim, W Ray; Israni, Ajay K

2012-04-01

Because of the shortage of deceased donor organs, transplant centers accept organs from marginal deceased donors, including older donors. Organ-specific donor risk indices have been developed to predict graft survival with various combinations of donor and recipient characteristics. Here we review the kidney donor risk index (KDRI) and the liver donor risk index (LDRI) and compare and contrast their strengths, limitations, and potential uses. The KDRI has a potential role in developing new kidney allocation algorithms. The LDRI allows a greater appreciation of the importance of donor factors, particularly for hepatitis C virus-positive recipients; as the donor risk index increases, the rates of allograft and patient survival among these recipients decrease disproportionately. The use of livers with high donor risk indices is associated with increased hospital costs that are independent of recipient risk factors, and the transplantation of livers with high donor risk indices into patients with Model for End-Stage Liver Disease scores < 15 is associated with lower allograft survival; the use of the LDRI has limited this practice. Significant regional variations in donor quality, as measured by the LDRI, remain in the United States. We also review other potential indices for liver transplantation, including donor-recipient matching and the retransplant donor risk index. Although substantial progress has been made in developing donor risk indices to objectively assess donor variables that affect transplant outcomes, continued efforts are warranted to improve these indices to enhance organ allocation policies and optimize allograft survival. Copyright © 2012 American Association for the Study of Liver Diseases.

The effect of specific proline residues on the kinetic stability of the triosephosphate isomerases of two trypanosomes.

PubMed

Guzmán-Luna, Valeria; Quezada, Andrea G; Díaz-Salazar, A Jessica; Cabrera, Nallely; Pérez-Montfort, Ruy; Costas, Miguel

2017-04-01

The effect of specific residues on the kinetic stability of two closely related triosephosphate isomerases (from Trypanosoma cruzi, TcTIM and Trypanosoma brucei, TbTIM) has been studied. Based on a comparison of their β-turn occurrence, we engineered two chimerical enzymes where their super secondary β-loop-α motifs 2 ((βα) 2 ) were swapped. Differential scanning calorimetry (DSC) experiments showed that the (βα) 2 motif of TcTIM inserted into TbTIM (2Tc) increases the kinetic stability. On the other hand, the presence of the (βα) 2 motif of TbTIM inserted into TcTIM (2Tb) gave a chimerical protein difficult to purify in soluble form and with a significantly reduced kinetic stability. The comparison of the contact maps of the (βα) 2 of TbTIM and TcTIM showed differences in the contact pattern of residues 43 and 49. In TcTIM these residues are prolines, located at the N-terminal of loop-2 and the C-terminal of α-helix-2. Twelve mutants were engineered involving residues 43 and 49 to study the effect over the unfolding activation energy barrier (E A ). A systematic analysis of DSC data showed a large decrease on the E A of TcTIM (ΔE A ranging from 468 to 678 kJ/mol) when the single and double proline mutations are present. The relevance of Pro43 to the kinetic stability is also revealed by mutation S43P, which increased the free energy of the transition state of TbTIM by 17.7 kJ/mol. Overall, the results indicate that protein kinetic stability can be severely affected by punctual mutations, disturbing the complex network of interactions that, in concerted action, determine protein stability. Proteins 2017; 85:571-579. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

International ring trial for the validation of an event-specific Golden Rice 2 quantitative real-time polymerase chain reaction method.

PubMed

Jacchia, Sara; Nardini, Elena; Bassani, Niccolò; Savini, Christian; Shim, Jung-Hyun; Trijatmiko, Kurniawan; Kreysa, Joachim; Mazzara, Marco

2015-05-27

This article describes the international validation of the quantitative real-time polymerase chain reaction (PCR) detection method for Golden Rice 2. The method consists of a taxon-specific assay amplifying a fragment of rice Phospholipase D α2 gene, and an event-specific assay designed on the 3' junction between transgenic insert and plant DNA. We validated the two assays independently, with absolute quantification, and in combination, with relative quantification, on DNA samples prepared in haploid genome equivalents. We assessed trueness, precision, efficiency, and linearity of the two assays, and the results demonstrate that both the assays independently assessed and the entire method fulfill European and international requirements for methods for genetically modified organism (GMO) testing, within the dynamic range tested. The homogeneity of the results of the collaborative trial between Europe and Asia is a good indicator of the robustness of the method.

Specific stabilization of CFTR by phosphatidylserine.

PubMed

Hildebrandt, Ellen; Khazanov, Netaly; Kappes, John C; Dai, Qun; Senderowitz, Hanoch; Urbatsch, Ina L

2017-02-01

The Cystic Fibrosis Transmembrane Conductance Regulator (CFTR, ABCC7) is a plasma membrane chloride ion channel in the ABC transporter superfamily. CFTR is a key target for cystic fibrosis drug development, and its structural elucidation would advance those efforts. However, the limited in vivo and in vitro stability of the protein, particularly its nucleotide binding domains, has made structural studies challenging. Here we demonstrate that phosphatidylserine uniquely stimulates and thermally stabilizes the ATP hydrolysis function of purified human CFTR. Among several lipids tested, the greatest stabilization was observed with brain phosphatidylserine, which shifted the Tm for ATPase activity from 22.7±0.8°C to 35.0±0.2°C in wild-type CFTR, and from 26.6±0.7°C to 42.1±0.2°C in a more stable mutant CFTR having deleted regulatory insertion and S492P/A534P/I539T mutations. When ATPase activity was measured at 37°C in the presence of brain phosphatidylserine, Vmax for wild-type CFTR was 240±60nmol/min/mg, a rate higher than previously reported and consistent with rates for other purified ABC transporters. The significant thermal stabilization of CFTR by phosphatidylserine may be advantageous in future structural and biophysical studies of CFTR. Copyright © 2016. Published by Elsevier B.V.

Evaluating the validity of self-reported smoking in Mexican adolescents

PubMed Central

Valladolid-López, María del Carmen; Barrientos-Gutiérrez, Tonatiuh; Reynales-Shigematsu, Luz Myriam; Thrasher, James F; Peláez-Ballestas, Ingris; Lazcano-Ponce, Eduardo; Hernández-Ávila, Mauricio

2015-01-01

Objectives We aimed to evaluate the validity of the self-reported smoking indicator used in the Global Youth Tobacco Survey (GYTS). Setting 43 middle and high-school classrooms from 26 schools were selected from Mexico City and Cuernavaca, Morelos. Participants A total of 1257 students provided both a questionnaire and a urine sample. Primary and secondary outcome Sensitivity and specificity of self-reported smoking compared to urinary cotinine. Validity indices were evaluated by subgroups of gender, social acceptability of smoking (ie, smoking parents or friends) and smoking frequency. Results Sensitivity and specificity for current smoking were 93.2% and 81.7%, respectively. Validity indices remained stable across gender. Parental smoking status moderated the validity of self-report, which had lower sensitivity in adolescents with non-smoking parents (86.7%) than in adolescents with smoking parents (96.6%). Sensitivity and specificity increased with smoking frequency. Conclusions This first validation study of self-reported current smoking used in the GYTS among Mexican adolescents suggests that self-reported smoking in the past 30 days is a valid and stable indicator of current smoking behaviour. This measure appears suitable for public health research and surveillance. PMID:26453588

Movement Assessment of Children (MAC): validity, reliability, stability and sensitivity to change in typically developing children.

PubMed

Chandler, L S; Terhorst, L; Rogers, J C; Holm, M B

2016-07-01

The purpose of this study was to establish the validity, reliability, stability and sensitivity to change of the family-centred Movement Assessment of Children (MAC) in typically developing infants/toddlers from 2 months (1 month 16 days) to 2 years (24 months 15 days) of age. Assessment of infant/toddler motor development is critical so that infants and toddlers who are at-risk for developmental delay or whose functional motor development is delayed can be monitored and receive therapy to improve their developmental outcomes. Infants/toddlers are thought to be more responsive during the MAC assessment because parents and siblings participate and elicit responses. Two hundred seventy six children and 405 assessments contributed to the establishment of age-related parameters for typically developing infants and toddlers on the MAC. The MAC assesses three core domains of functional movement (head control, upper extremities and hands, pelvis and lower extremities), and generates a core total score. Four explanatory domains serve to alert examiners to factors that may impact atypical development (general observations, special senses, primitive reflexes/reactions, muscle tone). Construct validity of functional motor development was examined using the relationship between incremental increases in scores and increases in participants' ages. Subsamples were used to establish inter-rater reliability, test-retest reliability, stability and sensitivity to change. Construct validity was established and inter-rater reliability ICCs for the core items and core total ranged from 0.83 to 0.99. Percent agreement for the explanatory items ranged from 0.72 to 0.96. Stability within age grouping was consistent from baseline to 6 months post-baseline, and sensitivity to change from baseline to 6 months was significant for all core items and the total score. The MAC has proven to be a well-constructed assessment of infant and toddler functional motor development. It is a

Behavioral Indicators on a Mobile Sensing Platform Predict Clinically Validated Psychiatric Symptoms of Mood and Anxiety Disorders

PubMed Central

Place, Skyler; Rubin, Channah; Gorrostieta, Cristina; Mead, Caroline; Kane, John; Marx, Brian P; Feast, Joshua; Deckersbach, Thilo; Pentland, Alex “Sandy”; Nierenberg, Andrew; Azarbayejani, Ali

2017-01-01

Background There is a critical need for real-time tracking of behavioral indicators of mental disorders. Mobile sensing platforms that objectively and noninvasively collect, store, and analyze behavioral indicators have not yet been clinically validated or scalable. Objective The aim of our study was to report on models of clinical symptoms for post-traumatic stress disorder (PTSD) and depression derived from a scalable mobile sensing platform. Methods A total of 73 participants (67% [49/73] male, 48% [35/73] non-Hispanic white, 33% [24/73] veteran status) who reported at least one symptom of PTSD or depression completed a 12-week field trial. Behavioral indicators were collected through the noninvasive mobile sensing platform on participants’ mobile phones. Clinical symptoms were measured through validated clinical interviews with a licensed clinical social worker. A combination hypothesis and data-driven approach was used to derive key features for modeling symptoms, including the sum of outgoing calls, count of unique numbers texted, absolute distance traveled, dynamic variation of the voice, speaking rate, and voice quality. Participants also reported ease of use and data sharing concerns. Results Behavioral indicators predicted clinically assessed symptoms of depression and PTSD (cross-validated area under the curve [AUC] for depressed mood=.74, fatigue=.56, interest in activities=.75, and social connectedness=.83). Participants reported comfort sharing individual data with physicians (Mean 3.08, SD 1.22), mental health providers (Mean 3.25, SD 1.39), and medical researchers (Mean 3.03, SD 1.36). Conclusions Behavioral indicators passively collected through a mobile sensing platform predicted symptoms of depression and PTSD. The use of mobile sensing platforms can provide clinically validated behavioral indicators in real time; however, further validation of these models and this platform in large clinical samples is needed. PMID:28302595

Development and validation of a selective, sensitive and stability indicating UPLC-MS/MS method for rapid, simultaneous determination of six process related impurities in darunavir drug substance.

PubMed

A, Vijaya Bhaskar Reddy; Yusop, Zulkifli; Jaafar, Jafariah; Aris, Azmi B; Majid, Zaiton A; Umar, Khalid; Talib, Juhaizah

2016-09-05

In this study a sensitive and selective gradient reverse phase UPLC-MS/MS method was developed for the simultaneous determination of six process related impurities viz., Imp-I, Imp-II, Imp-III, Imp-IV, Imp-V and Imp-VI in darunavir. The chromatographic separation was performed on Acquity UPLC BEH C18 (50 mm×2.1mm, 1.7μm) column using gradient elution of acetonitrile-methanol (80:20, v/v) and 5.0mM ammonium acetate containing 0.01% formic acid at a flow rate of 0.4mL/min. Both negative and positive electrospray ionization (ESI) modes were operated simultaneously using multiple reaction monitoring (MRM) for the quantification of all six impurities in darunavir. The developed method was fully validated following ICH guidelines with respect to specificity, linearity, limit of detection (LOD), limit of quantification (LOQ), accuracy, precision, robustness and sample solution stability. The method was able to quantitate Imp-I, Imp-IV, Imp-V at 0.3ppm and Imp-II, Imp-III, and Imp-VI at 0.2ppm with respect to 5.0mg/mL of darunavir. The calibration curves showed good linearity over the concentration range of LOQ to 250% for all six impurities. The correlation coefficient obtained was >0.9989 in all the cases. The accuracy of the method lies between 89.90% and 104.60% for all six impurities. Finally, the method has been successfully applied for three formulation batches of darunavir to determine the above mentioned impurities, however no impurity was found beyond the LOQ. This method is a good quality control tool for the trace level quantification of six process related impurities in darunavir during its synthesis. Copyright © 2016 Elsevier B.V. All rights reserved.

Stability-indicating validation of acitretin and isoacitretin in human plasma by LC-ESI-MS/MS bioanalytical method and its application to pharmacokinetic analysis.

PubMed

Kumar, Ajay; Monif, Tausif; Khuroo, Arshad; Sasmal, Dinakar; Goswami, Dipanjan; Lahkar, Vijay Kumar

2011-06-01

LC- ESI- MS/MS simultaneous bioanalytical method was developed to determine acitretin and its metabolite isoacitretin in human plasma using acitretin-d3 used as the internal standard for both analytes. The compounds were extracted using protein precipitation coupled with liquid-liquid extraction with flash freezing technique. Negative mass transitions (m/z) of acitretin, isoacitretin and acitretin-d3 were detected in multiple reactions monitoring (MRM) mode at 325.4 → 266.3, 325.2 → 266.1 and 328.3 → 266.3, respectively, with a turbo ion spray interface. The chromatographic separation was achieved on an Ascentis-RP amide column (4.6 × 150 mm, 5 µm) with mobile phase delivered in isocratic mode. The method was validated over a concentration range of 1.025-753.217 ng/mL for acitretin and 0.394-289.234 ng/mL for isoacitretin with a limit of quantification of 1.025 and 0.394 ng/mL. The intra-day and inter-day precisions were below 8.1% for acitretin and below 13.8% for isoacitretin, while accuracy was within ±7.0 and ±10.6% respectively. For the first time, the best possible conditions for plasma stability of acitretin and isoacitretin are presented and discussed with application to clinical samples. Copyright © 2010 John Wiley & Sons, Ltd.

Experimental and theoretical investigations on the validity of the geometrical optics model for calculating the stability of optical traps.

PubMed

Schut, T C; Hesselink, G; de Grooth, B G; Greve, J

1991-01-01

We have developed a computer program based on the geometrical optics approach proposed by Roosen to calculate the forces on dielectric spheres in focused laser beams. We have explicitly taken into account the polarization of the laser light and thd divergence of the laser beam. The model can be used to evaluate the stability of optical traps in a variety of different optical configurations. Our calculations explain the experimental observation by Ashkin that a stable single-beam optical trap, without the help of the gravitation force, can be obtained with a strongly divergent laser beam. Our calculations also predict a different trap stability in the directions orthogonal and parallel to the polarization direction of the incident light. Different experimental methods were used to test the predictions of the model for the gravity trap. A new method for measuring the radiation force along the beam axis in both the stable and instable regions is presented. Measurements of the radiation force on polystyrene spheres with diameters of 7.5 and 32 microns in a TEM00-mode laser beam showed a good qualitative correlation with the predictions and a slight quantitative difference. The validity of the geometrical approximations involved in the model will be discussed for spheres of different sizes and refractive indices.

Test-retest stability of the Task and Ego Orientation Questionnaire.

PubMed

Lane, Andrew M; Nevill, Alan M; Bowes, Neal; Fox, Kenneth R

2005-09-01

Establishing stability, defined as observing minimal measurement error in a test-retest assessment, is vital to validating psychometric tools. Correlational methods, such as Pearson product-moment, intraclass, and kappa are tests of association or consistency, whereas stability or reproducibility (regarded here as synonymous) assesses the agreement between test-retest scores. Indexes of reproducibility using the Task and Ego Orientation in Sport Questionnaire (TEOSQ; Duda & Nicholls, 1992) were investigated using correlational (Pearson product-moment, intraclass, and kappa) methods, repeated measures multivariate analysis of variance, and calculating the proportion of agreement within a referent value of +/-1 as suggested by Nevill, Lane, Kilgour, Bowes, and Whyte (2001). Two hundred thirteen soccer players completed the TEOSQ on two occasions, 1 week apart. Correlation analyses indicated a stronger test-retest correlation for the Ego subscale than the Task subscale. Multivariate analysis of variance indicated stability for ego items but with significant increases in four task items. The proportion of test-retest agreement scores indicated that all ego items reported relatively poor stability statistics with test-retest scores within a range of +/-1, ranging from 82.7-86.9%. By contrast, all task items showed test-retest difference scores ranging from 92.5-99%, although further analysis indicated that four task subscale items increased significantly. Findings illustrated that correlational methods (Pearson product-moment, intraclass, and kappa) are influenced by the range in scores, and calculating the proportion of agreement of test-retest differences with a referent value of +/-1 could provide additional insight into the stability of the questionnaire. It is suggested that the item-by-item proportion of agreement method proposed by Nevill et al. (2001) should be used to supplement existing methods and could be especially helpful in identifying rogue items in the

Psychometric Properties of Eating Disorder Instruments in Black and White Young Women: Internal Consistency, Temporal Stability, and Validity

ERIC Educational Resources Information Center

Bardone-Cone, Anna M.; Boyd, Clarissa A.

2007-01-01

Most of the major instruments in the eating disorder field have documented psychometric support only in predominantly White samples. The current study examined the internal consistency, temporal stability, and convergent and discriminant validity of a variety of eating disorder measures in Black (n = 97) and White (n = 179) female undergraduates.…

New Stability Indicating RP-HPLC Method for the Estimation of Cefpirome Sulphate in Bulk and Pharmaceutical Dosage Forms.

PubMed

Rao, Kareti Srinivasa; Kumar, Keshar Nargesh; Joydeep, Datta

2011-01-01

A simple stability indicating reversed-phase HPLC method was developed and subsequently validated for estimation of Cefpirome sulphate (CPS) present in pharmaceutical dosage forms. The proposed RP-HPLC method utilizes a LiChroCART-Lichrosphere100, C18 RP column (250 mm × 4mm × 5 μm) in an isocratic separation mode with mobile phase consisting of methanol and water in the proportion of 50:50 % (v/v), at a flow rate 1ml/min, and the effluent was monitored at 270 nm. The retention time of CPS was 2.733 min and its formulation was exposed to acidic, alkaline, photolytic, thermal and oxidative stress conditions, and the stressed samples were analyzed by the proposed method. The described method was linear over a range of 0.5-200μg/ml. The percentage recovery was 99.46. F-test and t-test at 95% confidence level were used to check the intermediate precision data obtained under different experimental setups; the calculated value was found to be less than the critical value.

Computation of Stability Derivatives of an oscillating cone for specific heat ratio = 1.66

NASA Astrophysics Data System (ADS)

Shabana, Aysha; Monis, Renita Sharon; Crasta, Asha; Khan, S. A.

2018-05-01

In this paper the expressions for stiffness and Damping derivatives are obtained in a closed form for perfect gas where the flow is quasi-steady and axi-axisymmetric, and the nose semi angle of the cone is such that the Mach number M 2 behind the shock M 2 ≥ 2.5. Results are presented for an oscillating cone for gas with = 1.666, at different Mach numbers and semi cone angles. The Stiffness derivative decreases with pivot position and also with semi vertex angle, there is substantial change in the stiffness derivative when semi-vertex has been increased from 5 degrees to ten degrees, further increase in the semi-vertex angle results in marginal change in the stiffness derivative. Due the marginal change in the Mach number level there is marginal increase in the magnitude of the stability and with further increase in the inertia level the stability derivative conform to the Mach number independence principle. The present theory for Oscillating cone is restricted to quasi-steady case. Viscous effects have been neglected. The expressions so obtained for stability derivative in pitch are valid for a slender ogive which often approximates to the whole fuselage of an aircraft.

Parameter Stability of the Functional–Structural Plant Model GREENLAB as Affected by Variation within Populations, among Seasons and among Growth Stages

PubMed Central

Ma, Yuntao; Li, Baoguo; Zhan, Zhigang; Guo, Yan; Luquet, Delphine; de Reffye, Philippe; Dingkuhn, Michael

2007-01-01

Background and Aims It is increasingly accepted that crop models, if they are to simulate genotype-specific behaviour accurately, should simulate the morphogenetic process generating plant architecture. A functional–structural plant model, GREENLAB, was previously presented and validated for maize. The model is based on a recursive mathematical process, with parameters whose values cannot be measured directly and need to be optimized statistically. This study aims at evaluating the stability of GREENLAB parameters in response to three types of phenotype variability: (1) among individuals from a common population; (2) among populations subjected to different environments (seasons); and (3) among different development stages of the same plants. Methods Five field experiments were conducted in the course of 4 years on irrigated fields near Beijing, China. Detailed observations were conducted throughout the seasons on the dimensions and fresh biomass of all above-ground plant organs for each metamer. Growth stage-specific target files were assembled from the data for GREENLAB parameter optimization. Optimization was conducted for specific developmental stages or the entire growth cycle, for individual plants (replicates), and for different seasons. Parameter stability was evaluated by comparing their CV with that of phenotype observation for the different sources of variability. A reduced data set was developed for easier model parameterization using one season, and validated for the four other seasons. Key Results and Conclusions The analysis of parameter stability among plants sharing the same environment and among populations grown in different environments indicated that the model explains some of the inter-seasonal variability of phenotype (parameters varied less than the phenotype itself), but not inter-plant variability (parameter and phenotype variability were similar). Parameter variability among developmental stages was small, indicating that parameter

Effects of McGill stabilization exercises and conventional physiotherapy on pain, functional disability and active back range of motion in patients with chronic non-specific low back pain.

PubMed

Ghorbanpour, Arsalan; Azghani, Mahmoud Reza; Taghipour, Mohammad; Salahzadeh, Zahra; Ghaderi, Fariba; Oskouei, Ali E

2018-04-01

[Purpose] The aim of this study was to compare the effects of "McGill stabilization exercises" and "conventional physiotherapy" on pain, functional disability and active back flexion and extension range of motion in patients with chronic non-specific low back pain. [Subjects and Methods] Thirty four patients with chronic non-specific low back pain were randomly assigned to McGill stabilization exercises group (n=17) and conventional physiotherapy group (n=17). In both groups, patients performed the corresponding exercises for six weeks. The visual analog scale (VAS), Quebec Low Back Pain Disability Scale Questionnaire and inclinometer were used to measure pain, functional disability, and active back flexion and extension range of motion, respectively. [Results] Statistically significant improvements were observed in pain, functional disability, and active back extension range of motion in McGill stabilization exercises group. However, active back flexion range of motion was the only clinical symptom that statistically increased in patients who performed conventional physiotherapy. There was no significant difference between the clinical characteristics while compared these two groups of patients. [Conclusion] The results of this study indicated that McGill stabilization exercises and conventional physiotherapy provided approximately similar improvement in pain, functional disability, and active back range of motion in patients with chronic non-specific low back pain. However, it appears that McGill stabilization exercises provide an additional benefit to patients with chronic non-specific low back, especially in pain and functional disability improvement.

[Nurse's competence indicators: linguistic and cultural validation of the Nurse Competence Scale].

PubMed

Finotto, Stefano; Cantarelli, William

2009-01-01

For some years, the clinical performance of new-graduate nurses, has been a leading topic in international scientific literature. In Italy there are many criticisms to basic education; ever since the basic education moved from the regional schools to the university, the main question that the teachers, the clinical nurses and the nursing managers are asking is whether the level of competence of new-graduates is appropriate to the demands of the world of work. Many criticisms have been addressed to the gap between theory and practice and between education and clinic. In Italy this has stimulated a debate towards a shared definition of competence and especially towards defining indicators that can assess/measure this phenomenon. The purposes of this study are: translating the indicators of Nurse Competence Scale (NCS) in the Italian language and test its validity and reliability; provide a tool for evaluating competence in Italian in order to use it in the context of our country. after a research on the Medline and Cinhal electronic data base, the NCS was identified and submitted to a process of linguistic translation (English-Italian-English) and to a process of validation using the test-retest methodology (test of Wilcoxon), the Intraclass Correlation Coefficient (ICC) and Cronbach's alpha. the evaluation given by nurses in the first administration does not differ significantly with those of the second one. For all sections of the NCS the ICC reports values greater than 0.85. the Nurse Competence Scale appears valid in its Italian version and it might be used to measure the competences of Italian nurses.

78 FR 5810 - AHRQ Standing Workgroup for Quality Indicator Measure Specification

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-28

... AHRQ Quality Indicators (QIs), their technical specifications, and associated methodological issues.... The time- limited workgroup is more restricted to specific clinical or methodological issues, while..., data enhancements, and methodological advances. The standing workgroup may potentially provide guidance...

Value-Added Teacher Estimates as Part of Teacher Evaluations: Exploring the Effects of Data and Model Specifications on the Stability of Teacher Value-Added Scores

ERIC Educational Resources Information Center

Kersting, Nicole B.; Chen, Mei-kuang; Stigler, James W.

2013-01-01

If teacher value-added estimates (VAEs) are to be used as indicators of individual teacher performance in teacher evaluation and accountability systems, it is important to understand how much VAEs are affected by the data and model specifications used to estimate them. In this study we explored the effects of three conditions on the stability of…

78 FR 22883 - AHRQ Standing Workgroup for Quality Indicator Measure Specification

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-17

... Quality Indicators (QIs), their technical specifications, and associated methodological issues. The...-limited workgroup is more restricted to specific clinical or methodological issues, while the standing... enhancements, and methodological advances. The standing workgroup may potentially provide guidance for the...

Validation of the Hebrew version of the Burn Specific Health Scale-Brief questionnaire.

PubMed

Stavrou, Demetris; Haik, Josef; Wiser, Itay; Winkler, Eyal; Liran, Alon; Holloway, Samantha; Boyd, Julie; Zilinsky, Isaac; Weissman, Oren

2015-02-01

The Burns Specific Health Scale-Brief (BSHS-B) questionnaire is a suitable measurement tool for the assessment of general, physical, mental, and social health aspects of the burn survivor. To translate, culturally adapt and validate the BSHS-B to Hebrew (BSHS-H), and to investigate its psychometric properties. Eighty-six Hebrew speaking burn survivors filled out the BSHS-B and SF-36 questionnaires. Ten of them (11.63%) completed a retest. The psychometric properties of the scale were evaluated. Internal consistency, criterion validity, and construct validity were assessed using interclass correlation coefficient, Cronbach's alpha statistic, Spearman rank test, and Mann-Whitney U test respectively. BSHS-H Cronbach's alpha coefficient was 0.97. Test-retest interclass coefficients were between 0.81 and 0.98. BSHS-H was able to discriminate between facial burns, hand burns and burns >10% body surface area (p<0.05). BSHS-H and SF-36 were positively correlated (r(2)=0.667, p<0.01). BSHS-H is a reliable and valid instrument for use in the Israeli burn survivor population. The translation and cross-cultural adaptation of this disease specific scale allows future comparative international studies. Copyright © 2014 Elsevier Ltd and ISBI. All rights reserved.

Validation of the Lupus Nephritis Clinical Indices in Childhood-Onset Systemic Lupus Erythematosus

PubMed Central

Mina, Rina; Abulaban, Khalid; Klein-Gitelman, Marisa; Eberhard, Anne; Ardoin, Stacy; Singer, Nora; Onel, Karen; Tucker, Lori; O’Neil, Kathleen; Wright, Tracey; Brooks, Elizabeth; Rouster-Stevens, Kelly; Jung, Lawrence; Imundo, Lisa; Rovin, Brad; Witte, David; Ying, Jun; Brunner, Hermine I.

2015-01-01

Objective To validate clinical indices of lupus nephritis (LN) activity and damage when used in children against the criterion standard of kidney biopsy findings. Methods In 83 children requiring kidney biopsy the SLE Disease Activity Index Renal Domain (SLEDAI-R); British Isles Lupus Assessment Group index Renal Domain (BILAG-R), Systemic Lupus International Collaborating Clinics Renal Activity (SLICC-RAS) and Damage Index Renal Domain (SDI-R) were measured. Fixed effect and logistic models were done to predict International Society of Nephrology/Renal Pathology Society (ISN/RPS) class; low/moderate vs. high LN-activity [NIH Activity Index (NIH-AI) score: ≤ 10 vs. > 10; Tubulointerstitial Activity Index (TIAI) score: ≤ 5 vs. > 5) or the absence vs. presence of LN chronicity [NIH Chronicity Index (NIH-CI) score: 0 vs. ≥ 1]. Results There were 10, 50 and 23 patients with class I/II, III/IV and V, respectively. Scores of the clinical indices did not differentiate among patients by ISN/RPS class. The SLEDAI-R and SLICC-RAS but not the BILAG-R differed with LN-activity status defined by NIH-AI scores, while only the SLEDAI-R scores differed between LN-activity status based on TIAI scores. The sensitivity and specificity of the SDI-R to capture LN chronicity was 23.5% and 91.7%, respectively. Despite designed to measure LN-activity, SLICC-RAS and SLEDAI-R scores significantly differed with LN chronicity status. Conclusion Current clinical indices of LN fail to discriminate ISN/RPS Class in children. Despite its shortcomings, the SLEDAI-R appears to best for measuring LN activity in a clinical setting. The SDI-R is a poor correlate of LN chronicity. PMID:26213987

Severity Indices of Personality Problems (SIPP-118): Development, Factor Structure, Reliability, and Validity

ERIC Educational Resources Information Center

Verheul, Roel; Andrea, Helene; Berghout, Caspar C.; Dolan, Conor; Busschbach, Jan J. V.; van der Kroft, Petra J. A.; Bateman, Anthony W.; Fonagy, Peter

2008-01-01

This article describes a series of studies involving 2,730 participants on the development and validity testing of the Severity Indices of Personality Problems (SIPP), a self-report questionnaire covering important core components of (mal)adaptive personality functioning. Results show that the 16 facets constituted homogeneous item clusters (i.e.,…

Cognitive performance and electrophysiological indices of cognitive control: a validation study of conflict adaptation.

PubMed

Clayson, Peter E; Larson, Michael J

2012-05-01

Psychiatric and neurologic disorders are associated with deficits in the postconflict recruitment of cognitive control. The primary aim of this study was to validate the relationship between cognitive functioning and indices of conflict adaptation. Event-related potentials were obtained from 89 healthy individuals who completed an Eriksen flanker task. Neuropsychological domains tested included memory, verbal fluency, and attention/executive functioning. Behavioral measures and N2 amplitudes showed significant conflict adaptation (i.e., previous-trial congruencies influenced current-trial measures). Higher scores on the attention/executive functioning and verbal fluency domains were associated with larger incongruent-trial N2 conflict adaptation; measures of cognitive functioning were not related to behavioral indices. This study provides initial validation of N2 conflict adaptation effects as cognitive function-related aspects of cognitive control. Copyright © 2012 Society for Psychophysiological Research.

Quality indicators for eye bank.

PubMed

Acharya, Manisha; Biswas, Saurabh; Das, Animesh; Mathur, Umang; Dave, Abhishek; Singh, Ashok; Dubey, Suneeta

2018-03-01

The aim of this study is to identify quality indicators of the eye bank and validate their effectivity. Adverse reaction rate, discard rate, protocol deviation rate, and compliance rate were defined as Quality Indicators of the eye bank. These were identified based on definition of quality that captures two dimensions - "result quality" and "process quality." The indicators were measured and tracked as part of quality assurance (QA) program of the eye bank. Regular audits were performed to validate alignment of standard operating procedures (SOP) with regulatory and surgeon acceptance standards and alignment of activities performed in the eye bank with the SOP. Prospective study of the indicators was performed by comparing their observed values over the period 2011-2016. Adverse reaction rate decreased more than 8-fold (from 0.61% to 0.07%), discard rate decreased and stabilized at 30%, protocol deviation rate decreased from 1.05% to 0.08%, and compliance rate reported by annual quality audits improved from 59% to 96% at the same time. In effect, adverse reaction rate, discard rate, and protocol deviation rate were leading indicators, and compliance rate was the trailing indicator. These indicators fulfill an important gap in available literature on QA in eye banking. There are two ways in which these findings can be meaningful. First, eye banks which are new to quality measurement can adopt these indicators. Second, eye banks which are already deeply engaged in quality improvement can test these indicators in their eye bank, thereby incorporating them widely and improving them over time.

Behavioral Indicators on a Mobile Sensing Platform Predict Clinically Validated Psychiatric Symptoms of Mood and Anxiety Disorders.

PubMed

Place, Skyler; Blanch-Hartigan, Danielle; Rubin, Channah; Gorrostieta, Cristina; Mead, Caroline; Kane, John; Marx, Brian P; Feast, Joshua; Deckersbach, Thilo; Pentland, Alex Sandy; Nierenberg, Andrew; Azarbayejani, Ali

2017-03-16

There is a critical need for real-time tracking of behavioral indicators of mental disorders. Mobile sensing platforms that objectively and noninvasively collect, store, and analyze behavioral indicators have not yet been clinically validated or scalable. The aim of our study was to report on models of clinical symptoms for post-traumatic stress disorder (PTSD) and depression derived from a scalable mobile sensing platform. A total of 73 participants (67% [49/73] male, 48% [35/73] non-Hispanic white, 33% [24/73] veteran status) who reported at least one symptom of PTSD or depression completed a 12-week field trial. Behavioral indicators were collected through the noninvasive mobile sensing platform on participants' mobile phones. Clinical symptoms were measured through validated clinical interviews with a licensed clinical social worker. A combination hypothesis and data-driven approach was used to derive key features for modeling symptoms, including the sum of outgoing calls, count of unique numbers texted, absolute distance traveled, dynamic variation of the voice, speaking rate, and voice quality. Participants also reported ease of use and data sharing concerns. Behavioral indicators predicted clinically assessed symptoms of depression and PTSD (cross-validated area under the curve [AUC] for depressed mood=.74, fatigue=.56, interest in activities=.75, and social connectedness=.83). Participants reported comfort sharing individual data with physicians (Mean 3.08, SD 1.22), mental health providers (Mean 3.25, SD 1.39), and medical researchers (Mean 3.03, SD 1.36). Behavioral indicators passively collected through a mobile sensing platform predicted symptoms of depression and PTSD. The use of mobile sensing platforms can provide clinically validated behavioral indicators in real time; however, further validation of these models and this platform in large clinical samples is needed. ©Skyler Place, Danielle Blanch-Hartigan, Channah Rubin, Cristina Gorrostieta

Computational evaluation of load carriage effects on gait balance stability.

PubMed

Mummolo, Carlotta; Park, Sukyung; Mangialardi, Luigi; Kim, Joo H

2016-01-01

Evaluating the effects of load carriage on gait balance stability is important in various applications. However, their quantification has not been rigorously addressed in the current literature, partially due to the lack of relevant computational indices. The novel Dynamic Gait Measure (DGM) characterizes gait balance stability by quantifying the relative effects of inertia in terms of zero-moment point, ground projection of center of mass, and time-varying foot support region. In this study, the DGM is formulated in terms of the gait parameters that explicitly reflect the gait strategy of a given walking pattern and is used for computational evaluation of the distinct balance stability of loaded walking. The observed gait adaptations caused by load carriage (decreased single support duration, inertia effects, and step length) result in decreased DGM values (p < 0.0001), which indicate that loaded walking motions are more statically stable compared with the unloaded normal walking. Comparison of the DGM with other common gait stability indices (the maximum Floquet multiplier and the margin of stability) validates the unique characterization capability of the DGM, which is consistently informative of the presence of the added load.

One-year temporal stability and predictive and incremental validity of the body, eating, and exercise comparison orientation measure (BEECOM) among college women.

PubMed

Fitzsimmons-Craft, Ellen E; Bardone-Cone, Anna M

2014-01-01

This study examined the one-year temporal stability and the predictive and incremental validity of the Body, Eating, and Exercise Comparison Measure (BEECOM) in a sample of 237 college women who completed study measures at two time points about one year apart. One-year temporal stability was high for the BEECOM total and subscale (i.e., Body, Eating, and Exercise Comparison Orientation) scores. Additionally, the BEECOM exhibited predictive validity in that it accounted for variance in body dissatisfaction and eating disorder symptomatology one year later. These findings held even after controlling for body mass index and existing measures of social comparison orientation. However, results regarding the incremental validity of the BEECOM, or its ability to predict change in these constructs over time, were more mixed. Overall, this study demonstrated additional psychometric properties of the BEECOM among college women, further establishing the usefulness of this measure for more comprehensively assessing eating disorder-related social comparison. Copyright © 2013 Elsevier Ltd. All rights reserved.

Development of RP UPLC-TOF/MS, stability indicating method for omeprazole and its related substances by applying two level factorial design; and identification and synthesis of non-pharmacopoeial impurities.

PubMed

Jadhav, Sushant Bhimrao; Kumar, C Kiran; Bandichhor, Rakeshwar; Bhosale, P N

2016-01-25

A new UPLC-TOF/MS compatible, reverse phase-stability indicating method was developed for determination of Omeprazole (OMP) and its related substances in pharmaceutical dosage forms by implementing Design of Experiment (DoE) i.e. two level full factorial Design (2(3)+3 center points=11 experiments) to understand the Critical Method Parameters (CMP) and its relation with Critical Method Attribute (CMA); to ensure robustness of the method. The separation of eleven specified impurities including conversion product of OMP related compound F (13) and G (14) i.e. Impurity-I (1), OMP related compound-I (11) and OMP 4-chloro analog (12) was achieved in a single method on Acquity BEH shield RP18 100 × 2.1 mm, 1.7 μm column, with inlet filter (0.2 μm) using gradient elution and detector wavelength at 305 nm and validated in accordance with ICH guidelines and found to be accurate, precise, reproducible, robust and specific. The drug was found to degrade extensively in heat, humidity and acidic conditions and forms unknown degradation products during stability studies. The same method was used for LC-MS analysis to identify m/z and fragmentation of maximum unknown impurities (Non-Pharmacopoeial) i.e. Impurity-I (1), Impurity-III (3), Impurity-V (5) and Impurity-VIII (9) formed during stability studies. Based on the results, degradation pathway for the drug has been proposed and synthesis of identified impurities i.e. impurities (Impurity-I (1), Impurity-III (3), Impurity-V (5) and Impurity-VIII (9)) are discussed in detail to ensure in-depth understanding of OMP and its related impurities and optimum performance during lifetime of the product. Copyright © 2015. Published by Elsevier B.V.

Development and validation of empirical indices to assess the insulinemic potential of diet and lifestyle

PubMed Central

Tabung, Fred K.; Wang, Weike; Fung, Teresa T.; Hu, Frank B.; Smith-Warner, Stephanie A.; Chavarro, Jorge E.; Fuchs, Charles S.; Willett, Walter C.; Giovannucci, Edward L.

2017-01-01

The glycemic and insulin indices assess postprandial glycemic and insulin response to foods respectively, which may not reflect the long-term effects of diet on insulin response. We developed and evaluated the validity of four empirical indices to assess the insulinemic potential of usual diets and lifestyles, using dietary, lifestyle and biomarker data from the Nurses’ Health Study (NHS, n=5,812 for hyperinsulinemia, n=3,929 for insulin resistance). The four indices were: the empirical dietary index for hyperinsulinemia (EDIH) and empirical lifestyle index for hyperinsulinemia (ELIH); empirical dietary index for insulin resistance (EDIR) and empirical lifestyle index for insulin resistance (ELIR). We entered 39 food frequency questionnaire-derived food groups in stepwise linear regression models and defined indices as the patterns most predictive of fasting plasma C-peptide, for the hyperinsulinemia pathway (EDIH and ELIH); and of the triglyceride/high density lipoprotein-cholesterol (TG/HDL) ratio, for the insulin resistance pathway (EDIR and ELIR). We evaluated the validity of indices in two independent samples from NHS-II and Health Professionals Follow-up Study (HPFS) using multivariable-adjusted linear regression analyses to calculate relative concentrations of biomarkers. EDIH is comprised of 18 food groups; 13 were positively associated with C-peptide, five inversely. EDIR is comprised of 18 food groups; ten were positively associated with TG/HDL and eight inversely. Lifestyle indices had fewer dietary components, and included BMI and physical activity as components. In the validation samples, all indices significantly predicted biomarker concentrations, e.g., the relative concentrations (95%CI) of the corresponding biomarkers comparing extreme index quintiles in HPFS were: EDIH, 1.29(1.22, 1.37); ELIH, 1.78(1.68, 1.88); EDIR, 1.44(1.34, 1.55); ELIR, 2.03(1.89, 2.19); all P-trend<0.0001. The robust associations of these novel hypothesis-driven indices

Role of the protein in the DNA sequence specificity of the cleavage site stabilized by the camptothecin topoisomerase IB inhibitor: a metadynamics study

PubMed Central

Coletta, Andrea; Desideri, Alessandro

2013-01-01

Camptothecin (CPT) is a topoisomerase IB (TopIB) selective inhibitor whose derivatives are currently used in cancer therapy. TopIB cleaves DNA at any sequence, but in the presence of CPT the only stabilized protein–DNA covalent complex is the one having a thymine in position −1 with respect to the cleavage site. A metadynamics simulation of two TopIB–DNA–CPT ternary complexes differing for the presence of a thymine or a cytosine in position −1 indicates the occurrence of two different drug’s unbinding pathways. The free-energy difference between the bound state and the transition state is large when a thymine is present in position −1 and is strongly reduced in presence of a cytosine, in line with the different drug stabilization properties of the two systems. Such a difference is strictly related to the changes in the hydrogen bond network between the protein, the DNA and the drug in the two systems, indicating a direct role of the protein in determining the specificity of the cleavage site sequence stabilized by the CPT. Calculations carried out in presence of one compound of the indenoisoquinoline family (NSC314622) indicate a comparable energy difference between the bound and the transition state independently of the presence of a thymine or a cytosine in position −1, in line with the experimental results. PMID:24003027

Recent Advances in Heliogyro Solar Sail Structural Dynamics, Stability, and Control Research

NASA Technical Reports Server (NTRS)

Wilkie, W. Keats; Warren, Jerry E.; Horta, Lucas G.; Lyle, Karen H.; Juang, Jer-Nan; Gibbs, S. Chad; Dowell, Earl H.; Guerrant, Daniel V.; Lawrence, Dale

2015-01-01

Results from recent NASA sponsored research on the structural dynamics, stability, and control characteristics of heliogyro solar sails are summarized. Specific areas under investigation include coupled nonlinear finite element analysis of heliogyro membrane blade with solar radiation pressure effects, system identification of spinning membrane structures, and solarelastic stability analysis of heliogyro solar sails, including stability during blade deployment. Recent results from terrestrial 1-g blade dynamics and control experiments on "rope ladder" membrane blade analogs, and small-scale in vacuo system identification experiments with hanging and spinning high-aspect ratio membranes will also be presented. A low-cost, rideshare payload heliogyro technology demonstration mission concept is used as a mission context for these heliogyro structural dynamics and solarelasticity investigations, and is also described. Blade torsional dynamic response and control are also shown to be significantly improved through the use of edge stiffening structural features or inclusion of modest tip masses to increase centrifugal stiffening of the blade structure. An output-only system identification procedure suitable for on-orbit blade dynamics investigations is also developed and validated using ground tests of spinning sub-scale heliogyro blade models. Overall, analytical and experimental investigations to date indicate no intractable stability or control issues for the heliogyro solar sail concept.

Model Validation for Propulsion - On the TFNS and LES Subgrid Models for a Bluff Body Stabilized Flame

NASA Technical Reports Server (NTRS)

Wey, Thomas

2017-01-01

This paper summarizes the reacting results of simulating a bluff body stabilized flame experiment of Volvo Validation Rig using a releasable edition of the National Combustion Code (NCC). The turbulence models selected to investigate the configuration are the sub-grid scaled kinetic energy coupled large eddy simulation (K-LES) and the time-filtered Navier-Stokes (TFNS) simulation. The turbulence chemistry interaction used is linear eddy mixing (LEM).

Predictors, Indicators, and Validated Measures of Dependence in Menthol Smokers

PubMed Central

Muhammad-Kah, Raheema; Rimmer, Lonnie; Liang, Qiwei

2014-01-01

This article presents a comprehensive review of the menthol cigarette dependence-related literature and results from an original analysis of the Total Exposure Study (TES), which included 1,100 menthol and 2,400 nonmenthol adult smokers. The substantial scientific evidence available related to age of first cigarette, age of regular use, single-item dependence indicators (smoking frequency, cigarettes per day, time to first cigarette, night waking to smoke), smoking duration, numerous validated and widely accepted measures of nicotine/cigarette dependence, and our analysis of the TES do not support that menthol smokers are more dependent than nonmenthol smokers or that menthol increases dependence. PMID:24738914

Indicators of the relative availability of healthy versus unhealthy foods in supermarkets: a validation study.

PubMed

Vandevijvere, Stefanie; Mackenzie, Tara; Mhurchu, Cliona Ni

2017-04-26

In-store availability of healthy and unhealthy foods may influence consumer purchases. Methods used to measure food availability, however, vary widely. A simple, valid, and reliable indicator to collect comparable data on in-store food availability is needed. Cumulative linear shelf length of and variety within 22 healthy and 28 unhealthy food groups, determined based on a comparison of three nutrient profiling systems, were measured in 15 New Zealand supermarkets. Inter-rater reliability was tested in one supermarket by a second researcher. The construct validity of five simple indicators of relative availability of healthy versus unhealthy foods was assessed against this 'gold standard'. Cumulative linear shelf length was a more sensitive and feasible measure of food availability than variety. Four out of five shelf length ratio indicators were significantly associated with the gold standard (ρ = 0.70-0.75). Based on a non-significant difference from the 'gold standard' (d = 0.053 ± 0.040) and feasibility, the ratio of cumulative linear shelf length of fresh and frozen fruits and vegetables versus soft and energy drinks, crisps and snacks, sweet biscuits and confectionery performed best for use in New Zealand supermarkets. Four out of the five shelf length ratio indicators of the relative availability of healthy versus unhealthy foods in-store tested could be used for future research and monitoring, but additional validation studies in other settings and countries are recommended. Consistent use of those shelf length ratio indicators could enhance comparability of supermarket food availability between studies, and help inform policies to create healthy consumer food retail environments.

Linguistic and clinical validation of the Arabic-translated Aberdeen Menorrhagia Severity Scale as an indicator of quality of life for women with abnormal uterine bleeding.

PubMed

Abu-Rafea, Basim F; Vilos, George A; Al Jasser, Rakia S; Al Anazy, Reem M; Javaid, Khalida; Al-Mandeel, Hazem M

2012-08-01

To develop a conceptually and semantically valid Arabic version of a validated disease-specific instrument of quality of life (QoL) for women with abnormal uterine bleeding (AUB). This is a prospective cohort study conducted at the Department of Obstetrics & Gynecology, King Saud University, Riyadh, Kingdom of Saudi Arabia between December 2010 and December 2011 following ethics approval. Forward translation of the Aberdeen Menorrhagia Severity Scale (AMSS) from English into Arabic was followed by backward translation of the consensus target (Arabic) version into the source (English) language. Subsequently, a final target (Arabic) language version was created. Sixty-one Arabic-speaking women of reproductive age participated in the study. The final Arabic questionnaire was administered to 41 women with self-perceived normal menses (Group 1) on 2 occasions 2 weeks apart. Agreement in the answers deems the questionnaire reliable. The final Arabic version was administered to 20 women with self-perceived AUB (Group 2), and their scores were compared with the first response of Group 1. A significant difference between the groups deems the questionnaire valid. For linguistic validation; intra-class correlation coefficient (ICC) of 0.87 and Kappa statistics of 0.56 to 0.87 indicated good to excellent agreement. For clinical validation, there was a significant difference between Group 1 and 2 (p=0.001). The translated Arabic AMSS is a reliable and valid indicator of QoL in Saudi women with AUB.

Development of RP-HPLC, Stability Indicating Method for Degradation Products of Linagliptin in Presence of Metformin HCl by Applying 2 Level Factorial Design; and Identification of Impurity-VII, VIII and IX and Synthesis of Impurity-VII.

PubMed

Jadhav, Sushant B; Reddy, P Sunil; Narayanan, Kalyanaraman L; Bhosale, Popatrao N

2017-06-27

The novel reverse phase-high performance liquid chromatography (RP-HPLC), stability indicating method was developed for determination of linagliptin (LGP) and its related substances in linagliptin and metformin HCl (MET HCl) tablets by implementing design of experiment to understand the critical method parameters and their relation with critical method attributes; to ensure robustness of the method. The separation of nine specified impurities was achieved with a Zorbax SB-Aq 250 × 4.6 mm, 5 µm column, using gradient elution and a detector wavelength of 225 nm, and validated in accordance with International Conference on Harmonization (ICH) guidelines and found to be accurate, precise, reproducible, robust, and specific . The drug was found to be degrading extensively in heat, humidity, basic, and oxidation conditions and was forming degradation products during stability studies. After slight modification in the buffer and the column, the same method was used for liquid chromatography-mass spectrometry (LC-MS) and ultra-performance liquid chromatography -time-of-flight/mass spectrometry UPLC-TOF/MS analysis, to identify m/z and fragmentation of maximum unspecified degradation products i.e., Impurity-VII ( 7 ), Impurity-VIII ( 8 ), and Impurity-IX ( 9 ) formed during stability studies. Based on the results, a degradation pathway for the drug has been proposed and synthesis of Impurity-VII ( 7 ) is also discussed to ensure an in-depth understanding of LGP and its related degradation products and optimum performance during the lifetime of the product.

Medium fidelity modelling of loads in wind farms under non-neutral ABL stability conditions - a full-scale validation study

NASA Astrophysics Data System (ADS)

Larsen, G. C.; Larsen, T. J.; Chougule, A.

2017-05-01

The aim of the present paper is to demonstrate the capability of medium fidelity modelling of wind turbine component fatigue loading, when the wind turbines are subjected to wake affected non-stationary flow fields under non-neutral atmospheric stability conditions. To accomplish this we combine the classical Dynamic Wake Meandering model with a fundamental conjecture stating: Atmospheric boundary layer stability affects primary wake meandering dynamics driven by large turbulent scales, whereas wake expansion in the meandering frame of reference is hardly affected. Inclusion of stability (i.e. buoyancy) in description of both large- and small scale atmospheric boundary layer turbulence is facilitated by a generalization of the classical Mann spectral tensor, which consistently includes buoyancy effects. With non-stationary wind turbine inflow fields modelled as described above, fatigue loads are obtained using the state-of-the art aeroelastic model HAWC2. The Lillgrund offshore wind farm (WF) constitute an interesting case study for wind farm model validation, because the WT interspacing is small, which in turn means that wake effects are significant. A huge data set, comprising 5 years of blade and tower load recordings, is available for model validation. For a multitude of wake situations this data set displays a considerable scatter, which to a large degree seems to be caused by atmospheric boundary layer stability effects. Notable is also that rotating wind turbine components predominantly experience high fatigue loading for stable stratification with significant shear, whereas high fatigue loading of non-rotating wind turbine components are associated with unstable atmospheric boundary layer stratification.

An acute cough-specific quality-of-life questionnaire for children: Development and validation.

PubMed

Anderson-James, Sophie; Newcombe, Peter A; Marchant, Julie M; O'Grady, Kerry-Ann F; Acworth, Jason P; Stone, D Grant; Turner, Catherine T; Chang, Anne B

2015-05-01

Patient-relevant outcome measures are essential for high-quality clinical research, and quality-of-life (QoL) tools are the current standard. Currently, there is no validated children's acute cough-specific QoL questionnaire. The objective of this study was to develop and validate the Parent-proxy Children's Acute Cough-specific QoL Questionnaire (PAC-QoL). Using focus groups, a 48-item PAC-QoL questionnaire was developed and later reduced to 16 items by using the clinical impact method. Parents of children with a current acute cough (<2 weeks) at enrollment completed 2 validated cough score measures, the preliminary 48-item PAC-QoL, and 3 other questionnaires (the State Trait Anxiety Inventory [STAI], the Short-Form 8-item 24-hour recall Health Survey [SF-8], and the Depression, Anxiety, and Stress 21-item Scale [DASS21]). All measures were repeated on days 3 and 14. The median age of the 155 children enrolled was 2.3 years (interquartile range, 1.3-4.6). Median cough duration at enrollment was 3 days (interquartile range, 2-5). The reduced 16-item scale had high internal consistency (Cronbach α = 0.95). Evidence for repeatability and criterion validity was shown by significant correlations between the domains and total PAC-QoL scores and the SF-8 (r = -0.36 and -0.51), STAI (r = -0.27 and -0.39), and DASS21 (r = -0.32 and -0.41) scales on days 0 and 3, respectively. The final PAC-QoL questionnaire was sensitive to change over time, with changes significantly relating to changes in cough score measures (P < .001). The 16-item PAC-QoL is a reliable and valid outcome measure that assesses QoL related to childhood acute cough at a given time point and reflects changes in acute cough-specific QoL over time. Copyright © 2014 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

Development of Organ-Specific Donor Risk Indices

PubMed Central

Akkina, Sanjeev K.; Asrani, Sumeet K.; Peng, Yi; Stock, Peter; Kim, Ray; Israni, Ajay K.

2012-01-01

Due to the shortage of deceased donor organs, transplant centers accept organs from marginal deceased donors, including older donors. Organ-specific donor risk indices have been developed to predict graft survival using various combinations of donor and recipient characteristics. We will review the kidney donor risk index (KDRI) and liver donor risk index (LDRI) and compare and contrast their strengths, limitations, and potential uses. The Kidney Donor Risk Index has a potential role in developing new kidney allocation algorithms. The Liver Donor Risk Index allows for greater appreciation of the importance of donor factors, particularly for hepatitis C-positive recipients; as the donor risk index increases, rates of allograft and patient survival among these recipients decrease disproportionately. Use of livers with high donor risk index is associated with increased hospital costs independent of recipient risk factors, and transplanting livers with high donor risk index into patients with Model for End-Stage Liver Disease scores < 15 is associated with lower allograft survival; use of the Liver Donor Risk Index has limited this practice. Significant regional variation in donor quality, as measured by the Liver Donor Risk Index, remains in the United States. We also review other potential indices for liver transplant, including donor-recipient matching and the retransplant donor risk index. While substantial progress has been made in developing donor risk indices to objectively assess donor variables that affect transplant outcomes, continued efforts are warranted to improve these indices to enhance organ allocation policies and optimize allograft survival. PMID:22287036

Dimensional stability of flakeboards as affected by board specific gravity and flake alignment

Treesearch

Robert L. Geimer

1982-01-01

The objective was to determine the relationship between the variables specific gravity (SG) and flake alignment and the dimensional stability properties of flakeboard. Boards manufactured without a density gradient were exposed to various levels of relative humidity and a vacuum-pressure soak (VPS) treatment. Changes in moisture content (MC), thickness swelling, and...

Inter-observer agreement, diagnostic sensitivity and specificity of animal-based indicators of young lamb welfare.

PubMed

Phythian, C J; Toft, N; Cripps, P J; Michalopoulou, E; Winter, A C; Jones, P H; Grove-White, D; Duncan, J S

2013-07-01

A scientific literature review and consensus of expert opinion used the welfare definitions provided by the Farm Animal Welfare Council (FAWC) Five Freedoms as the framework for selecting a set of animal-based indicators that were sensitive to the current on-farm welfare issues of young lambs (aged ≤ 6 weeks). Ten animal-based indicators assessed by observation - demeanour, response to stimulation, shivering, standing ability, posture, abdominal fill, body condition, lameness, eye condition and salivation were tested as part of the objective of developing valid, reliable and feasible animal-based measures of lamb welfare The indicators were independently tested on 966 young lambs from 17 sheep flocks across Northwest England and Wales during December 2008 to April 2009 by four trained observers. Inter-observer reliability was assessed using Fleiss's kappa (κ), and the pair-wise agreement with an experienced, observer designated as the 'test standard observer' (TSO) was examined using Cohen's κ. Latent class analysis (LCA) estimated the sensitivity (Se) and specificity (Sp) of each observer without assuming a gold standard and predicted the Se and Sp of randomly selected observers who may apply the indicators in the future. Overall, good levels of inter-observer reliability, and high levels of Sp were identified for demeanour (κ = 0.54, Se ≥ 0.70, Sp ≥ 0.98), stimulation (κ = 0.57, Se = 0.30 to 0.77, Sp ≥ 0.98), shivering (κ = 0.55, Se = 0.37 to 0.85, Sp ≥ 0.99), standing ability (0.54, Se ≥ 0.80, Sp ≥ 0.99), posture (κ = 0.45, Se ≥ 0.56, Sp = 0.99), abdominal fill (κ = 0.44, Se = 0.39 to 0.98, Sp = 0.99), body condition (κ = 0.72, Se ⩾ 0.38 to 0.90, Sp = 0.99), lameness (κ = 0.68, Se > 0.73, Sp = 1.00), and eye condition (κ = 0.72, Se ≥ 0.86, Sp = 0.99). LCA predicted that randomly selected observers had Se > 0.77 (acceptable), and Sp ≥ 0.98 (high) for assessments of demeanour, lameness, abdominal fill posture, body condition and eye

Spanish adaptation and validation of the supportive & palliative care indicators tool – SPICT-ESTM

PubMed Central

Fachado, Alfonso Alonso; Martínez, Noemí Sansó; Roselló, Marisa Martín; Rial, José Javier Ventosa; Oliver, Enric Benito; García, Rafael Gómez; García, José Manuel Fernández

2018-01-01

ABSTRACT OBJECTIVE To culturally adapt and validate the SPICTTM to Spanish, which is a brief and simple tool to support a better identification of chronic patients who have palliative care needs. METHODS For this study, we designed a multicenter and national project between the centers of Galicia, Balearic Islands, and Andalusia. For the process of translation and cross-cultural adaptation of the SPICTTM to Spanish, we followed the steps proposed by Beaton et al. with successive translations and subsequent consensus of experts using the debriefing methodology. After the content validation was completed, the psychometric properties were validated. A prospective longitudinal study was designed with 188 patients from Galicia, the Balearic Islands, and Andalusia. The internal consistency and reliability of the test and retest was analyzed for 10 days by the same researcher. RESULTS For more than 90% of the participants of the SPICT-ESTM, it seems simple to be filled out, and they consider it written in an understandable language. The average time to apply the questionnaire without prior knowledge was 4 minutes and 45 seconds. To evaluate the internal consistency of the instrument, we used the Kuder-Richardson formula 20. Internal consistency is 0.71. The agreement index of the Kappa test is between 0.983 and 0.797 for the different items. CONCLUSIONS In this study, we demonstrate the equivalence of content with the original. In addition, the validation of the psychometric properties establishes that the SPICT-ESTM maintains adequate reliability and stability. If we add the satisfaction shown by the professionals and the ease of use, the SPICT-ESTM is an adequate tool for the identification of palliative patients with chronic diseases and palliative care needs. PMID:29364358

QTL validation and stability for volatile organic compounds (VOCs) in apple.

PubMed

Costa, Fabrizio; Cappellin, Luca; Zini, Elena; Patocchi, Andrea; Kellerhals, Markus; Komjanc, Matteo; Gessler, Cesare; Biasioli, Franco

2013-10-01

The aroma trait in apple is a key factor for fruit quality strongly affecting the consumer appreciation, and its detection and analysis is often an extremely laborious and time consuming procedure. Molecular markers associated to this trait can to date represent a valuable selection tool to overcome these limitations. QTL mapping is the first step in the process of targeting valuable molecular markers to be employed in marker-assisted breeding programmes (MAB). However, a validation step is usually required before a newly identified molecular marker can be implemented in marker-assisted selection. In this work the position of a set of QTLs associated to volatile organic compounds (VOCs) was confirmed and validated in three different environments in Switzerland, namely Wädenswil, Conthey and Cadenazzo, where the progeny 'Fiesta×Discovery' was replicated. For both QTL identification and validation, the phenotypic data were represented by VOCs produced by mature apple fruit and assessed with a Proton Transfer Reaction-Mass Spectrometer (PTR-MS) instrument. The QTL-VOC combined analysis performed among these three locations validated the presence of important QTLs in three specific genomic regions, two located in the linkage group 2 and one in linkage group 15, respectively, for compounds related to esters (m/z 43, 61 and 131) and to the hormone ethylene (m/z 28). The QTL set presented here confirmed that in apple some compounds are highly genetically regulated and stable across environments. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Validation of the Lupus Nephritis Clinical Indices in Childhood-Onset Systemic Lupus Erythematosus.

PubMed

Mina, Rina; Abulaban, Khalid; Klein-Gitelman, Marisa S; Eberhard, Barbara A; Ardoin, Stacy P; Singer, Nora; Onel, Karen; Tucker, Lori; O'neil, Kathleen; Wright, Tracey; Brooks, Elizabeth; Rouster-Stevens, Kelly; Jung, Lawrence; Imundo, Lisa; Rovin, Brad; Witte, David; Ying, Jun; Brunner, Hermine I

2016-02-01

To validate clinical indices of lupus nephritis activity and damage when used in children against the criterion standard of kidney biopsy findings. In 83 children requiring kidney biopsy, the Systemic Lupus Erythematosus Disease Activity Index renal domain (SLEDAI-R), British Isles Lupus Assessment Group index renal domain (BILAG-R), Systemic Lupus International Collaborating Clinics (SLICC) renal activity score (SLICC-RAS), and SLICC Damage Index renal domain (SDI-R) were measured. Fixed effects and logistic models were calculated to predict International Society of Nephrology/Renal Pathology Society (ISN/RPS) class; low-to-moderate versus high lupus nephritis activity (National Institutes of Health [NIH] activity index [AI]) score: ≤10 versus >10; tubulointerstitial activity index (TIAI) score: ≤5 versus >5; or the absence versus presence of lupus nephritis chronicity (NIH chronicity index) score: 0 versus ≥1. There were 10, 50, and 23 patients with ISN/RPS class I/II, III/IV, and V, respectively. Scores of the clinical indices did not differentiate among patients by ISN/RPS class. The SLEDAI-R and SLICC-RAS but not the BILAG-R differed with lupus nephritis activity status defined by NIH-AI scores, while only the SLEDAI-R scores differed between lupus nephritis activity status based on TIAI scores. The sensitivity and specificity of the SDI-R to capture lupus nephritis chronicity was 23.5% and 91.7%, respectively. Despite being designed to measure lupus nephritis activity, SLICC-RAS and SLEDAI-R scores significantly differed with lupus nephritis chronicity status. Current clinical indices of lupus nephritis fail to discriminate ISN/RPS class in children. Despite its shortcomings, the SLEDAI-R appears best for measuring lupus nephritis activity in a clinical setting. The SDI-R is a poor correlate of lupus nephritis chronicity. © 2016, American College of Rheumatology.

Stability of extemporaneous oral ribavirin liquid preparation.

PubMed

Chan, John P; Tong, Henry H Y; Chow, Albert H L

2004-01-01

Ribavirin is an antiviral agent commonly used in Hong Kong for the treatment of severe acute respiratory syndrome. The choice of oral ribavirin therapeutic products available in the local market is currently limited to capsules. The present study investigated the chemical stability of an oral ribavirin suspension (200 mg/5mL) prepared extemporaneously from oral capsules using a sugar-free suspension formula. The suspension was subjected to stability testing at 4 deg C for up to 28 days. Employing a validated stability-indicating high-performance liquid chromatographic method, the ribavirin content of the extemporaneous preparation has been demonstrated to exhibit negligible changes throughout the storage period. No degradation product was observable in all high-peroformance liquid chromatograms, suggesting that the suspension remained chermically stable under the stated conditions.

Development and validation of a vision-specific quality-of-life questionnaire for Timor-Leste.

PubMed

du Toit, Rènée; Palagyi, Anna; Ramke, Jacqueline; Brian, Garry; Lamoureux, Ecosse L

2008-10-01

To develop and determine the reliability and validity of a vision-specific quality-of-life instrument (TL-VSQOL) designed to assess the impact of distance and near vision impairment in adults living in Timor-Leste. A vision-specific quality-of-life questionnaire was developed, piloted, and administered to 704 Timorese aged >or=40 years during a population-based eye health rapid assessment. Rasch analysis was performed on the data of 457 participants with presenting near vision worse than N8 (78.5%) and/or distance vision worse than 6/18 (69.8%). Unidimensionality, item fit to the model, response category performance, differential item functioning, and targeting of items to participants were assessed. Initially, the questionnaire lacked fit to the Rasch model. Removal of two items concerning emotional well-being resulted in a fit of the data (overall item-trait interaction: chi(2) (df) = 81 (51); mean (SD) person and item fit residual values: -0.30 (1.02) and -0.32 (1.46), and good targeting of person ability and item difficulty was evident. Poorer distance and near visual acuities were significantly associated with worse quality-of-life scores (P < 0.001). Person separation reliability was substantial (0.93), indicating that the instrument can discriminate between groups with normal and impaired vision. All 17 items were free of differential item functioning, and there was no evidence of multidimensionality. This 17-item TL-VSQOL has high reliability, construct, and criterion validity and effective targeting. It can effectively assess the impact on quality of life of adult Timorese with distance and near vision impairment. The TL-VSQOL could be adapted for use in other low-resource settings.

German validation of the Conners Adult ADHD Rating Scales (CAARS) II: reliability, validity, diagnostic sensitivity and specificity.

PubMed

Christiansen, H; Kis, B; Hirsch, O; Matthies, S; Hebebrand, J; Uekermann, J; Abdel-Hamid, M; Kraemer, M; Wiltfang, J; Graf, E; Colla, M; Sobanski, E; Alm, B; Rösler, M; Jacob, C; Jans, T; Huss, M; Schimmelmann, B G; Philipsen, A

2012-07-01

The German version of the Conners Adult ADHD Rating Scales (CAARS) has proven to show very high model fit in confirmative factor analyses with the established factors inattention/memory problems, hyperactivity/restlessness, impulsivity/emotional lability, and problems with self-concept in both large healthy control and ADHD patient samples. This study now presents data on the psychometric properties of the German CAARS-self-report (CAARS-S) and observer-report (CAARS-O) questionnaires. CAARS-S/O and questions on sociodemographic variables were filled out by 466 patients with ADHD, 847 healthy control subjects that already participated in two prior studies, and a total of 896 observer data sets were available. Cronbach's-alpha was calculated to obtain internal reliability coefficients. Pearson correlations were performed to assess test-retest reliability, and concurrent, criterion, and discriminant validity. Receiver Operating Characteristics (ROC-analyses) were used to establish sensitivity and specificity for all subscales. Coefficient alphas ranged from .74 to .95, and test-retest reliability from .85 to .92 for the CAARS-S, and from .65 to .85 for the CAARS-O. All CAARS subscales, except problems with self-concept correlated significantly with the Barrett Impulsiveness Scale (BIS), but not with the Wender Utah Rating Scale (WURS). Criterion validity was established with ADHD subtype and diagnosis based on DSM-IV criteria. Sensitivity and specificity were high for all four subscales. The reported results confirm our previous study and show that the German CAARS-S/O do indeed represent a reliable and cross-culturally valid measure of current ADHD symptoms in adults. Copyright © 2011 Elsevier Masson SAS. All rights reserved.

Biological risk indicators for recurrent non-specific low back pain in adolescents.

PubMed

Jones, M A; Stratton, G; Reilly, T; Unnithan, V B

2005-03-01

A matched case-control study was carried out to evaluate biological risk indicators for recurrent non-specific low back pain in adolescents. Adolescents with recurrent non-specific low back pain (symptomatic; n = 28; mean (SD) age 14.9 (0.7) years) and matched controls (asymptomatic; n = 28; age 14.9 (0.7) years) with no history of non-specific low back pain participated. Measures of stature, mass, sitting height, sexual maturity (Tanner self assessment), lateral flexion of the spine, lumbar sagittal plane mobility (modified Schober), hip range of motion (Leighton flexometer), back and hamstring flexibility (sit and reach), and trunk muscle endurance (number of sit ups) were performed using standardised procedures with established reliability. Backward stepwise logistic regression analysis was performed, with the presence/absence of recurrent low back pain as the dependent variable and the biological measures as the independent variables. Hip range of motion, trunk muscle endurance, lumbar sagittal plane mobility, and lateral flexion of the spine were identified as significant risk indicators of recurrent low back pain (p<0.05). Follow up analysis indicated that symptomatic subjects had significantly reduced lateral flexion of the spine, lumbar sagittal plane mobility, and trunk muscle endurance (p<0.05). Hip range of motion, abdominal muscle endurance, lumbar flexibility, and lateral flexion of the spine were risk indicators for recurrent non-specific low back pain in a group of adolescents. These risk indicators identify the potential for exercise as a primary or secondary prevention method.

Comparing measured and modelled soil carbon: which site-specific variables are linked to high stability?

NASA Astrophysics Data System (ADS)

Robertson, Andy; Schipanski, Meagan; Ma, Liwang; Ahuja, Lajpat; McNamara, Niall; Smith, Pete; Davies, Christian

2016-04-01

Changes in soil carbon (C) stocks have been studied in depth over the last two decades, as net greenhouse gas (GHG) sinks are highlighted to be a partial solution to the causes of climate change. However, the stability of this soil C is often overlooked when measuring these changes. Ultimately a net sequestration in soils is far less beneficial if labile C is replacing more stable forms. To date there is no accepted framework for measuring soil C stability, and as a result there is considerable uncertainty associated with the simulated impacts of land management and land use change when using process-based systems models. However, a recent effort to equate measurable soil C fractions to model pools has generated data that help to assess the impacts of land management, and can ultimately help to reduce the uncertainty of model predictions. Our research compiles this existing fractionation data along with site metadata to create a simplistic statistical model able to quantify the relative importance of different site-specific conditions. Data was mined from 23 published studies and combined with original data to generate a dataset of 100+ land use change sites across Europe. For sites to be included they required soil C fractions isolated using the Zimmermann et al. (2007) method and specific site metadata (mean annual precipitation, MAP; mean annual temperature, MAT; soil pH; land use; altitude). Of the sites, 75% were used to develop a generalized linear mixed model (GLMM) to create coefficients where site parameters can be used to predict influence on the measured soil fraction C stocks. The remaining 25% of sites were used to evaluate uncertainty and validate this empirical model. Further, four of the aforementioned sites were used to simulate soil C dynamics using the RothC, DayCent and RZWQM2 models. A sensitivity analysis (4096 model runs for each variable applying Latin hypercube random sampling techniques) was then used to observe whether these models place

[Validation of the nutritional index in Mexican pre-teens with the sensitivity and specificity method].

PubMed

Saucedo-Molina, T J; Gómez-Peresmitré, G

1998-01-01

To determine the diagnostic validity of the nutritional index (NI) in a sample of Mexican preadolescents. A total of 256 preadolescents, between 10 and 12 years old, male and female, students from Mexico City, were used to establish the diagnostic validity of NI using the sensitivity and specificity method. The findings show that the conventional NI cut-off points showed good sensitivity and specificity for the diagnosis of low weight, normality and obesity but not for overweight. When the cut-off points of NI were normalized, the sensitivity, specificity and prediction potency values were more suitable in all categories. When working with preadolescents, it is better to use the new cut-off points of NI, to obtain more reliable diagnosis.

Inactivation of Adenovirus Type 5, Rotavirus WA and Male Specific Coliphage (MS2) in Biosolids by Lime Stabilization

PubMed Central

Hansen, Jacqueline J.; Warden, Paul S.; Margolin, Aaron B.

2007-01-01

The use of lime to reduce or eliminate pathogen content is a cost-effective treatment currently employed in many Class B biosolids production plants in the United States. A bench scale model of lime stabilization was designed to evaluate the survival of adenovirus type 5, rotavirus Wa, and the male specific bacteriophage, MS2, in various matrices. Each virus was initially evaluated independently in a reverse osmosis treated water matrix limed with an aqueous solution of calcium hydroxide for 24-hr at 22 ± 5°C. In all R/O water trials, adenovirus type 5, rotavirus Wa and MS2 were below detectable levels (<100.5 TCID50/mL and <1 PFU/mL respectively) following 0.1-hr of liming. Adenovirus type 5, rotavirus Wa, and MS2, were inoculated into composted, raw and previously limed matrices, representative of sludge and biosolids, to achieve a final concentration of approximately 104 PFU or TCID50/mL. Each matrix was limed for 24-hr at 22 ± 5°C and 4 ± 2°C. In all trials virus was below detectable levels following a 24-hr incubation. The time required for viral inactivation varied depending on the temperature and sample matrix. This research demonstrates reduction of adenovirus type 5, rotavirus Wa, and male-specific bacteriophage, in water, sludge and biosolids matrices following addition of an 8% calcium hydroxide slurry to achieve a pH of 12 for 2-hr reduced to 11.5 for 22-hr by addition of 0.1 N HCl. In these trials, MS2 was a conservative indicator of the efficacy of lime stabilization of adenovirus Type 5 and rotavirus Wa and therefore is proposed as a useful indicator organism. PMID:17431317

Fuzzy Logic Controller Stability Analysis Using a Satisfiability Modulo Theories Approach

NASA Technical Reports Server (NTRS)

Arnett, Timothy; Cook, Brandon; Clark, Matthew A.; Rattan, Kuldip

2017-01-01

While many widely accepted methods and techniques exist for validation and verification of traditional controllers, at this time no solutions have been accepted for Fuzzy Logic Controllers (FLCs). Due to the highly nonlinear nature of such systems, and the fact that developing a valid FLC does not require a mathematical model of the system, it is quite difficult to use conventional techniques to prove controller stability. Since safety-critical systems must be tested and verified to work as expected for all possible circumstances, the fact that FLC controllers cannot be tested to achieve such requirements poses limitations on the applications for such technology. Therefore, alternative methods for verification and validation of FLCs needs to be explored. In this study, a novel approach using formal verification methods to ensure the stability of a FLC is proposed. Main research challenges include specification of requirements for a complex system, conversion of a traditional FLC to a piecewise polynomial representation, and using a formal verification tool in a nonlinear solution space. Using the proposed architecture, the Fuzzy Logic Controller was found to always generate negative feedback, but inconclusive for Lyapunov stability.

Stability of the thermodynamic equilibrium - A test of the validity of dynamic models as applied to gyroviscous perpendicular magnetohydrodynamics

NASA Astrophysics Data System (ADS)

Faghihi, Mustafa; Scheffel, Jan; Spies, Guenther O.

1988-05-01

Stability of the thermodynamic equilibrium is put forward as a simple test of the validity of dynamic equations, and is applied to perpendicular gyroviscous magnetohydrodynamics (i.e., perpendicular magnetohydrodynamics with gyroviscosity added). This model turns out to be invalid because it predicts exponentially growing Alfven waves in a spatially homogeneous static equilibrium with scalar pressure.

Stimulation, Inhibition, or Stabilization of Na,K-ATPase Caused by Specific Lipid Interactions at Distinct Sites

PubMed Central

Habeck, Michael; Haviv, Haim; Katz, Adriana; Kapri-Pardes, Einat; Ayciriex, Sophie; Shevchenko, Andrej; Ogawa, Haruo; Toyoshima, Chikashi; Karlish, Steven J. D.

2015-01-01

The activity of membrane proteins such as Na,K-ATPase depends strongly on the surrounding lipid environment. Interactions can be annular, depending on the physical properties of the membrane, or specific with lipids bound in pockets between transmembrane domains. This paper describes three specific lipid-protein interactions using purified recombinant Na,K-ATPase. (a) Thermal stability of the Na,K-ATPase depends crucially on a specific interaction with 18:0/18:1 phosphatidylserine (1-stearoyl-2-oleoyl-sn-glycero-3-phospho-l-serine; SOPS) and cholesterol, which strongly amplifies stabilization. We show here that cholesterol associates with SOPS, FXYD1, and the α subunit between trans-membrane segments αTM8 and -10 to stabilize the protein. (b) Polyunsaturated neutral lipids stimulate Na,K-ATPase turnover by >60%. A screen of the lipid specificity showed that 18:0/20:4 and 18:0/22:6 phosphatidylethanolamine (PE) are the optimal phospholipids for this effect. (c) Saturated phosphatidylcholine and sphingomyelin, but not saturated phosphatidylserine or PE, inhibit Na,K-ATPase activity by 70–80%. This effect depends strongly on the presence of cholesterol. Analysis of the Na,K-ATPase activity and E1-E2 conformational transitions reveals the kinetic mechanisms of these effects. Both stimulatory and inhibitory lipids poise the conformational equilibrium toward E2, but their detailed mechanisms of action are different. PE accelerates the rate of E1 → E2P but does not affect E2(2K)ATP → E13NaATP, whereas sphingomyelin inhibits the rate of E2(2K)ATP → E13NaATP, with very little effect on E1 → E2P. We discuss these lipid effects in relation to recent crystal structures of Na,K-ATPase and propose that there are three separate sites for the specific lipid interactions, with potential physiological roles to regulate activity and stability of the pump. PMID:25533463

Validated stability-indicating spectrophotometric methods for the determination of Silodosin in the presence of its degradation products.

PubMed

Boltia, Shereen A; Abdelkawy, Mohammed; Mohammed, Taghreed A; Mostafa, Nahla N

2018-09-05

Five simple, rapid, accurate, and precise spectrophotometric methods are developed for the determination of Silodosin (SLD) in the presence of its acid induced and oxidative induced degradation products. Method A is based on dual wavelength (DW) method; two wavelengths are selected at which the absorbance of the oxidative induced degradation product is the same, so wavelengths 352 and 377 nm are used to determine SLD in the presence of its oxidative induced degradation product. Method B depends on induced dual wavelength theory (IDW), which is based on selecting two wavelengths on the zero-order spectrum of SLD where the difference in absorbance between them for the spectrum of acid induced degradation products is not equal to zero so through multiplying by the equality factor, the absorption difference is made to be zero for the acid induced degradation product while it is still significant for SLD. Method C is first derivative ( 1 D) spectrophotometry of SLD and its degradation products. Peak amplitudes are measured at 317 and 357 nm. Method D is ratio difference spectrophotometry (RD) where the drug is determined by the difference in amplitude between two selected wavelengths, at 350 and 277 nm for the ratio spectrum of SLD and its acid induced degradation products while for the ratio spectrum of SLD and its oxidative induced degradation products the difference in amplitude is measured at 345 and 292 nm. Method E depends on measuring peak amplitudes of the first derivative of the ratio ( 1 DD) where peak amplitudes are measured at 330 nm in the presence of the acid induced degradation product and measured by peak to peak technique at 326 and 369 nm in the presence of the oxidative induced degradation product. The proposed methods are validated according to ICH recommendations. The calibration curves for all the proposed methods are linear over a concentration range of 5-70 μg/mL. The selectivity of the proposed methods was tested using different

Caught in the struggle with food craving: Development and validation of a new cognitive fusion measure.

PubMed

Duarte, Cristiana; Pinto-Gouveia, José; Ferreira, Cláudia; Silva, Bárbara

2016-06-01

Cognitive fusion has been related to the development and maintenance of a series of mental health difficulties. Specifically, growing research on eating psychopathology has been demonstrating the important role of cognitive fusion related to body image in these disorders. Nonetheless, cognitive fusion specifically focused on eating remained to be investigated. The current study aimed at developing and validating the Cognitive Fusion Questionnaire-Food Craving, a measure assessing the extent to which an individual is fused with food-craving undesirable and disturbing thoughts and urges. This study was conducted with distinct samples comprising men and women from the student and general population. A principal component analysis was conducted to assess the scale's structure, which was further examined in a confirmatory factor analysis. The scale's reliability and validities were also analysed. Results indicated that the CFQ-FC presented a one-dimensional structure with 7 items, accounting for 66.14% of the variance. A CFA confirmed the plausibility of the measurement model, which was found to be invariant in both sexes. The CFQ-FC also revealed very good internal consistency, construct reliability, temporal stability, and convergent and divergent validity, being positively associated with similar constructs and with indicators of eating and general psychopathology. CFQ-FC also discriminated individuals with clinically significant symptoms of binge eating from participants with no symptoms. Finally, the CFQ-FC presents incremental validity over a global measure of cognitive fusion in predicting eating psychopathology, namely binge eating. The CFQ-FC is a psychometrically sound measure that allows for a brief and reliable assessment of eating-related cognitive fusion. This is a novel measure that may significantly contribute for the assessment of this specific dimension of cognitive fusion and for the understanding of its role in eating psychopathology. Copyright �

Aeromechanical stability analysis of COPTER

NASA Technical Reports Server (NTRS)

Yin, Sheng K.; Yen, Jing G.

1988-01-01

A plan was formed for developing a comprehensive, second-generation system with analytical capabilities for predicting performance, loads and vibration, handling qualities, aeromechanical stability, and acoustics. This second-generation system named COPTER (COmprehensive Program for Theoretical Evaluation of Rotorcraft) is designed for operational efficiency, user friendliness, coding readability, maintainability, transportability, modularity, and expandability for future growth. The system is divided into an executive, a data deck validator, and a technology complex. At present a simple executive, the data deck validator, and the aeromechanical stability module of the technology complex were implemented. The system is described briefly, the implementation of the technology module is discussed, and correlation data presented. The correlation includes hingeless-rotor isolated stability, hingeless-rotor ground-resonance stability, and air-resonance stability of an advanced bearingless-rotor in forward flight.

Atmospheric stability and complex terrain: comparing measurements and CFD

NASA Astrophysics Data System (ADS)

Koblitz, T.; Bechmann, A.; Berg, J.; Sogachev, A.; Sørensen, N.; Réthoré, P.-E.

2014-12-01

For wind resource assessment, the wind industry is increasingly relying on Computational Fluid Dynamics models that focus on modeling the airflow in a neutrally stratified surface layer. So far, physical processes that are specific to the atmospheric boundary layer, for example the Coriolis force, buoyancy forces and heat transport, are mostly ignored in state-of-the-art flow solvers. In order to decrease the uncertainty of wind resource assessment, the effect of thermal stratification on the atmospheric boundary layer should be included in such models. The present work focuses on non-neutral atmospheric flow over complex terrain including physical processes like stability and Coriolis force. We examine the influence of these effects on the whole atmospheric boundary layer using the DTU Wind Energy flow solver EllipSys3D. To validate the flow solver, measurements from Benakanahalli hill, a field experiment that took place in India in early 2010, are used. The experiment was specifically designed to address the combined effects of stability and Coriolis force over complex terrain, and provides a dataset to validate flow solvers. Including those effects into EllipSys3D significantly improves the predicted flow field when compared against the measurements.

Blood miRNAs as sensitive and specific biological indicators of environmental and occupational exposure to volatile organic compound (VOC).

PubMed

Song, Mi-Kyung; Ryu, Jae-Chun

2015-10-01

To date, there is still shortage of highly sensitive and specific minimally invasive biomarkers for assessment of environmental toxicants exposure. Because of the significance of microRNA (miRNA) in various diseases, circulating miRNAs in blood may be unique biomarkers for minimally invasive prediction of toxicants exposure. We identified and validated characteristic miRNA expression profiles of human whole blood in workers exposed to volatile organic compounds (VOCs) and compared the usefulness of miRNA indicator of VOCs with the effectiveness of the already used urinary biomarkers of occupational exposure. Using a microarray based approach we screened and detected deregulated miRNAs in their expression in workers exposed to VOCs (toluene [TOL], xylene [XYL] and ethylbenzene [EBZ]). Total 169 workers from four dockyards were enrolled in current study, and 50 subjects of them were used for miRNA microarray analysis. We identified 467 miRNAs for TOL, 211 miRNAs for XYL, and 695 miRNAs for XYL as characteristic discernible exposure indicator, which could discerned each VOC from the control group with higher accuracy, sensitivity, and specificity than urinary biomarkers. Current observations from this study point out that the altered levels of circulating miRNAs can be a reliable novel, minimally invasive biological indicator of occupational exposure to VOCs. Copyright © 2015 Elsevier GmbH. All rights reserved.

Stabilized display of coronary x-ray image sequences

NASA Astrophysics Data System (ADS)

Close, Robert A.; Whiting, James S.; Da, Xiaolin; Eigler, Neal L.

2004-05-01

Display stabilization is a technique by which a feature of interest in a cine image sequence is tracked and then shifted to remain approximately stationary on the display device. Prior simulations indicate that display stabilization with high playback rates ( 30 f/s) can significantly improve detectability of low-contrast features in coronary angiograms. Display stabilization may also help to improve the accuracy of intra-coronary device placement. We validated our automated tracking algorithm by comparing the inter-frame difference (jitter) between manual and automated tracking of 150 coronary x-ray image sequences acquired on a digital cardiovascular X-ray imaging system with CsI/a-Si flat panel detector. We find that the median (50%) inter-frame jitter between manual and automatic tracking is 1.41 pixels or less, indicating a jump no further than an adjacent pixel. This small jitter implies that automated tracking and manual tracking should yield similar improvements in the performance of most visual tasks. We hypothesize that cardiologists would perceive a benefit in viewing the stabilized display as an addition to the standard playback of cine recordings. A benefit of display stabilization was identified in 87 of 101 sequences (86%). The most common tasks cited were evaluation of stenosis and determination of stent and balloon positions. We conclude that display stabilization offers perceptible improvements in the performance of visual tasks by cardiologists.

Stability-Indicating HPTLC Method for Simultaneous Estimation of Flurbiprofen and Chloramphenicol in Ophthalmic Solution.

PubMed

Sadakwala, Vaishnavi M; Chauhan, Renu S; Shah, Shailesh A; Shah, Dinesh R

2016-01-01

A specific, accurate and reproducible stability-indicating high performance thin layer chromatography (HPTLC) method was developed for the estimation of flurbiprofen and chloramphenicol in the presence of their degradation products. Degradation studies of both the drugs were carried out in acidic, alkaline, neutral, oxidative, photolytic and thermal stress conditions. Separation was performed on thin layer chromatography plate precoated with silica gel 60 F254 using ethyl acetate : n-hexane : methanol : tri-ethyl amine (5 : 4 : 2 : 0.5, v/v/v/v). Spots at retention factor 0.29 and 0.62 were recognized as flurbiprofen and chloramphenicol, respectively, and were quantified through densitometric measurements at wavelength 267 nm. Method was found to be linear over the concentration range 12-60 ng/spot with correlation coefficient of 0.9997 for flurbiprofen and 200-1,000 ng/spot with correlation coefficient of 0.9977 for chloramphenicol. The proposed method was applied to the estimation of flurbiprofen and chloramphenicol in commercial ophthalmic formulation. The developed HPTLC method can be applied for routine analysis of flurbiprofen and chloramphenicol in the presence of their degradation products in their individual as well as combined pharmaceutical formulations. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

External validation of a nomogram for prediction of side-specific extracapsular extension at robotic radical prostatectomy.

PubMed

Zorn, Kevin C; Gallina, Andrea; Hutterer, Georg C; Walz, Jochen; Shalhav, Arieh L; Zagaja, Gregory P; Valiquette, Luc; Gofrit, Ofer N; Orvieto, Marcelo A; Taxy, Jerome B; Karakiewicz, Pierre I

2007-11-01

Several staging tools have been developed for open radical prostatectomy (ORP) patients. However, the validity of these tools has never been formally tested in patients treated with robot-assisted laparoscopic radical prostatectomy (RALP). We tested the accuracy of an ORP-derived nomogram in predicting the rate of extracapsular extension (ECE) in a large RALP cohort. Serum prostate specific antigen (PSA) and side-specific clinical stage and biopsy Gleason sum information were used in a previously validated nomogram predicting side-specific ECE. The nomogram-derived predictions were compared with the observed rate of ECE, and the accuracy of the predictions was quantified. Each prostate lobe was analyzed independently. As complete data were available for 576 patients, the analyses targeted 1152 prostate lobes. Median age and serum PSA concentration at radical prostatectomy were 60 years and 5.4 ng/mL, respectively. The majority of side-specific clinical stages were T(1c) (993; 86.2%). Most side-specific biopsy Gleason sums were 6 (572; 49.7%). The median side-specific percentages of positive cores and of cancer were, respectively, 20.0% and 5.0%. At final pathologic review, 107 patients (18.6%) had ECE, and side-specific ECE was present in 117 patients (20.3%). The nomogram was 89% accurate in the RALP cohort v 84% in the previously reported ORP validation. The ORP side-specific ECE nomogram is highly accurate in the RALP population, suggesting that predictive and possibly prognostic tools developed in ORP patients may be equally accurate in their RALP counterparts.

Using Colored Stochastic Petri Net (CS-PN) software for protocol specification, validation, and evaluation

NASA Technical Reports Server (NTRS)

Zenie, Alexandre; Luguern, Jean-Pierre

1987-01-01

The specification, verification, validation, and evaluation, which make up the different steps of the CS-PN software are outlined. The colored stochastic Petri net software is applied to a Wound/Wait protocol decomposable into two principal modules: request or couple (transaction, granule) treatment module and wound treatment module. Each module is specified, verified, validated, and then evaluated separately, to deduce a verification, validation and evaluation of the complete protocol. The colored stochastic Petri nets tool is shown to be a natural extension of the stochastic tool, adapted to distributed systems and protocols, because the color conveniently takes into account the numerous sites, transactions, granules and messages.

SPECIFIC HEAT INDICATOR

DOEpatents

Horn, F.L.; Binns, J.E.

1961-05-01

Apparatus for continuously and automatically measuring and computing the specific heat of a flowing solution is described. The invention provides for the continuous measurement of all the parameters required for the mathematical solution of this characteristic. The parameters are converted to logarithmic functions which are added and subtracted in accordance with the solution and a null-seeking servo reduces errors due to changing voltage drops to a minimum. Logarithmic potentiometers are utilized in a unique manner to accomplish these results.

Stability of Cyclophosphamide in Extemporaneous Oral Suspensions

PubMed Central

Kennedy, Rachel; Groepper, Daniel; Tagen, Michael; Christensen, Robbin; Navid, Fariba; Gajjar, Amar; Stewart, Clinton F.

2010-01-01

Background Cyclophosphamide, an alkylating agent, is widely used for the treatment of many adult and pediatric malignancies. The stability of cyclophosphamide in aqueous- and methylcellulose-based oral suspending vehicles is currently unknown. Objectives The goals of this study were (1) to develop and validate a stability-indicating HPLC method to measure cyclophosphamide concentrations in simple syrup and Ora-Plus, and (2) to assess the 56-day chemical stability and physical appearance of cyclophosphamide in these suspensions at both room temperature and 4°C. Methods The i.v. formulation of cyclophosphamide was diluted to 20 mg/mL in normal saline, compounded 1:1 with either suspending vehicle, and stored in the dark in 3mL amber polypropylene oral syringes at 4°C and 22°C. Aliquots from each syringe were obtained on days 0, 3, 7, 14, 21, 28, 35, 42, 49, and 56 and assayed using the validated stability-indicating HPLC-UV method. A C18 analytical column was used to separate cyclophosphamide from the internal standard, ifosfamide, with a mobile phase of 21% acetonitrile in 79% sodium phosphate buffer. The suspension was examined for odor change, visually examined under normal fluorescent light for color change, and examined under a light microscope for evidence of microbial growth. Results Samples of cyclophosphamide in both simple syrup and Ora-Plus were stable when kept at 4°C for at least 56 days. At room temperature, cyclophosphamide in simple syrup and Ora-Plus had a shelf life of 8 and 3 days, respectively. No changes in color or odor or evidence of microbial growth were observed. Conclusion Cyclophosphamide can be extemporaneously prepared in simple syrup or Ora-Plus and stored at least 2 months under refrigeration without significant degradation. PMID:20103616

Stability of cyclophosphamide in extemporaneous oral suspensions.

PubMed

Kennedy, Rachel; Groepper, Daniel; Tagen, Michael; Christensen, Robbin; Navid, Fariba; Gajjar, Amar; Stewart, Clinton F

2010-02-01

Cyclophosphamide, an alkylating agent, is widely used for the treatment of many adult and pediatric malignancies. The stability of cyclophosphamide in aqueous- and methylcellulose-based oral suspending vehicles is currently unknown. To develop and validate a stability-indicating high-performance liquid chromatography (HPLC) method to measure cyclophosphamide concentrations in simple syrup and Ora-Plus, and assess the 56-day chemical stability and physical appearance of cyclophosphamide in these suspensions at both room temperature (22 degrees C) and 4 degrees C. The intravenous formulation of cyclophosphamide was diluted to 20 mg/mL in NaCl 0.9%, compounded 1:1 with either suspending vehicle, and stored in the dark in 3-mL amber polypropylene oral syringes at 4 degrees C and 22 degrees C. Aliquots from each syringe were obtained on days 0, 3, 7, 14, 21, 28, 35, 42, 49, and 56 and assayed using the validated stability-indicating HPLC-UV method. A C18 analytical column was used to separate cyclophosphamide from the internal standard, ifosfamide, with a mobile phase of 21% acetonitrile in 79% sodium phosphate buffer. The suspension was examined for odor change, visually examined under normal fluorescent light for color change, and examined under a light microscope for evidence of microbial growth. Samples of cyclophosphamide in both simple syrup and Ora-Plus were stable when kept at 4 degrees C for at least 56 days. At room temperature, cyclophosphamide in simple syrup and Ora-Plus had a shelf life of 8 and 3 days, respectively. No changes in color or odor or evidence of microbial growth were observed. Cyclophosphamide can be extemporaneously prepared in simple syrup or Ora-Plus and stored for at least 2 months under refrigeration without significant degradation.

Validating the Heat Stress Indices for Using In Heavy Work Activities in Hot and Dry Climates.

PubMed

Hajizadeh, Roohalah; Golbabaei, Farideh; Farhang Dehghan, Somayeh; Beheshti, Mohammad Hossein; Jafari, Sayed Mohammad; Taheri, Fereshteh

2016-01-01

Necessity of evaluating heat stress in the workplace, require validation of indices and selection optimal index. The present study aimed to assess the precision and validity of some heat stress indices and select the optimum index for using in heavy work activities in hot and dry climates. It carried out on 184 workers from 40 brick kilns workshops in the city of Qom, central Iran (as representative hot and dry climates). After reviewing the working process and evaluation the activity of workers and the type of work, environmental and physiological parameters according to standards recommended by International Organization for Standardization (ISO) including ISO 7243 and ISO 9886 were measured and indices were calculated. Workers engaged in indoor kiln experienced the highest values of natural wet temperature, dry temperature, globe temperature and relative humidity among studied sections (P<0.05). Indoor workplaces had the higher levels of all environmental parameters than outdoors (P=0.0001), except for air velocity. The wet-bulb globe temperature (WBGT) and heat stress index (HSI) indices had the highest correlation with other physiological parameters among the other heat stress indices. Relationship between WBGT index and carotid artery temperature (r=0.49), skin temperature (r=0.319), and oral temperature (r=0.203) was statistically significant (P=0.006). Since WBGT index, as the most applicable index for evaluating heat stress in workplaces is approved by ISO, and due to the positive features of WBGT such as ease of measurement and calculation, and with respect to some limitation in application of HSI; WBGT can be introduced as the most valid empirical index of heat stress in the brick workshops.

Trait-specific dependence in romantic relationships.

PubMed

Ellis, Bruce J; Simpson, Jeffry A; Campbell, Lorne

2002-10-01

Informed by three theoretical frameworks--trait psychology, evolutionary psychology, and interdependence theory--we report four investigations designed to develop and test the reliability and validity of a new construct and accompanying multiscale inventory, the Trait-Specific Dependence Inventory (TSDI). The TSDI assesses comparisons between present and alternative romantic partners on major dimensions of mate value. In Study 1, principal components analyses revealed that the provisional pool of theory-generated TSDI items were represented by six factors: Agreeable/Committed, Resource Accruing Potential, Physical Prowess, Emotional Stability, Surgency, and Physical Attractiveness. In Study 2, confirmatory factor analysis replicated these results on a different sample and tested how well different structural models fit the data. Study 3 provided evidence for the convergent and discriminant validity of the six TSDI scales by correlating each one with a matched personality trait scale that did not explicitly incorporate comparisons between partners. Study 4 provided further validation evidence, revealing that the six TSDI scales successfully predicted three relationship outcome measures--love, time investment, and anger/upset--above and beyond matched sets of traditional personality trait measures. These results suggest that the TSDI is a reliable, valid, and unique construct that represents a new trait-specific method of assessing dependence in romantic relationships. The construct of trait-specific dependence is introduced and linked with other theories of mate value.

Design of an unified chassis controller for rollover prevention, manoeuvrability and lateral stability

NASA Astrophysics Data System (ADS)

Yoon, Jangyeol; Yim, Seongjin; Cho, Wanki; Koo, Bongyeong; Yi, Kyongsu

2010-11-01

This paper describes a unified chassis control (UCC) strategy to prevent vehicle rollover and improve both manoeuvrability and lateral stability. Since previous researches on rollover prevention are only focused on the reduction of lateral acceleration, the manoeuvrability and lateral stability cannot be guaranteed. For this reason, it is necessary to design a UCC controller to prevent rollover and improve lateral stability by integrating electronic stability control, active front steering and continuous damping control. This integration is performed through switching among several control modes and a simulation is performed to validate the proposed method. Simulation results indicate that a significant improvement in rollover prevention, manoeuvrability and lateral stability can be expected from the proposed UCC system.

A Study of the Validity of Language Usage as an Indicator of Ethnic Identification.

ERIC Educational Resources Information Center

Patella, Victoria Morrow

In determining whether Spanish usage is a valid indicator of ethnic identification, 669 Texas high school sophomores (3 Negroes, 70 Anglos, and 596 Mexican Americans) were interviewed. Mexican American respondents were then isolated on the basis of response to 4 questions, and their responses regarding family were grouped under 2 headings: (1)…

Validity, sensitivity and specificity of the mentation, behavior and mood subscale of the UPDRS.

PubMed

Holroyd, Suzanne; Currie, Lillian J; Wooten, G Frederick

2008-06-01

The unified Parkinson's disease rating scale (UPDRS) is the most widely used tool to rate the severity and the stage of Parkinson's disease (PD). However, the mentation, behavior and mood (MBM) subscale of the UPDRS has received little investigation regarding its validity and sensitivity. Three items of this subscale were compared to criterion tests to examine validity, sensitivity and specificity. Ninety-seven patients with idiopathic PD were assessed on the UPDRS. Scores on three items of the MBM subscale, intellectual impairment, thought disorder and depression, were compared to criterion tests, the telephone interview for cognition status (TICS), psychiatric assessment for psychosis and the geriatric depression scale (GDS). Non-parametric tests of association were performed to examine concurrent validity of the MBM items. The sensitivities, specificities and optimal cutoff scores for each MBM item were estimated by receiver operating characteristic (ROC) curve analysis. The MBM items demonstrated low to moderate correlation with the criterion tests, and the sensitivity and specificity were not strong. Even using a score of 7.0 on the items of the MBM demonstrated a sensitivity/specificity of only 0.19/0.48 for intellectual impairment, 0.60/0.72 for thought disorder and 0.61/0.87 for depression. Using a more appropriate cutoff of 2.0 revealed sensitivities of 0.01, 0.38 and 0.13 respectively. The MBM subscale items of intellectual impairment, thought disorder and depression are not appropriate for screening or diagnostic purposes. Tools such as the TICS and the GDS should be considered instead.

A validated stability indicating RP-HPLC method for estimation of Armodafinil in pharmaceutical dosage forms and characterization of its base hydrolytic product.

PubMed

Venkateswarlu, Kambham; Rangareddy, Ardhgeri; Narasimhaiah, Kanaka; Sharma, Hemraj; Bandi, Naga Mallikarjuna Raja

2017-01-01

The main objective of present study was to develop a RP-HPLC method for estimation of Armodafinil in pharmaceutical dosage forms and characterization of its base hydrolytic product. The method was developed for Armodafinil estimation and base hydrolytic products were characterized. The separation was carried out on C18 column by using mobile phase as mixture of water and methanol (45:55%v/v). Eluents were detected at 220nm at 1ml/min. Stress studies were performed with milder conditions followed by stronger conditions so as to get sufficient degradation around 20%. A total of five degradation products were detected and separated from analyte. The linearity of the proposed method was investigated in the range of 20-120µg/ml for Armodafinil. The detection limit and quantification limit was found to be 0.01183μg/ml and 0.035µg/ml respectively. The precision % RSD was found to be less than 2% and the recovery was between 98-102%. Armodafinil was found to be more sensitive to the base hydrolysis and yielded its carboxylic acid as degradant. The developed method was stability indicating assay, suitable to quantify Armodafinil in presence of possible degradants. The drug was sensitive to acid, base &photolytic stress and resistant to thermal &oxidation.

Validation of MIL-F-9490D. General Specification for Flight Control System for Piloted Military Aircraft. Volume III. C-5A Heavy Logistics Transport Validation

DTIC Science & Technology

1977-04-01

U* AFFDL-TR-77-7 0 VOLUME III " 󈧦 VALIDATION OF MIL-F-9490D - GENERAL SPECIFICATION FOR FLIGHT CONTROL SYSTEM "FOR PILOTED MILITARY AIRCRAFT VOLUME...ý A1O 1 C I\\.FFBL Ti(-77-7. Vol. III f Validatio~n of UL-P-9-490D#,*. General Spacificatior "~inal 1’l -_t e for Flight ContrsA Zyn’om for Piloted...cation MIL-F-9490D (USAF), "Flight Control Systems - Design, Installation and Test of Piloted Aircraft, General Specifications for," dated 6 June 1975, by

Testing Postural Stability: Are the Star Excursion Balance Test and Biodex Balance System Limits of Stability Tests Consistent?

PubMed

Glave, A Page; Didier, Jennifer J; Weatherwax, Jacqueline; Browning, Sarah J; Fiaud, Vanessa

2016-01-01

There are a variety of options to test postural stability; however many physical tests lack validity information. Two tests of postural stability - the Star Excursion Balance Test (SEBT) and Biodex Balance System Limits of Stability Test (LOS) - were examined to determine if similar components of balance were measured. Healthy adults (n=31) completed the LOS (levels 6 and 12) and SEBT (both legs). SEBT directions were offset by 180° to approximate LOS direction. Correlations and partial correlations controlling for height were analyzed. Correlations were significant for SEBT 45° and LOS back-left (6: r=-0.41; 12: r=-0.42; p<0.05), SEBT 90° and LOS 6 left (r=-0.51, p<0.05), SEBT 135(o) and LOS 6 front-left (r=-0.53, p<0.05), SEBT overall and LOS 6 overall (r=-0.43, p<0.05). Partial correlations were significant for SEBT 90° and LOS 6 left (rSEBT,LOS·H=-0.45, p<0.05) and SEBT 135° and LOS 6 front-left (rSEBT,LOS·H=-0.51, p<0.05), and SEBT overall and LOS 6 overall (rSEBT,LOS·H=-0.37, p<0.05). These findings indicate the tests seem to assess different components of balance. Research is needed to determine and define what specific components of balance are being assessed. Care must be taken when choosing balance tests to best match the test to the purpose of testing (fall risk, athletic performance, etc.). Copyright © 2015 Elsevier B.V. All rights reserved.

Investigation of the microbial community structure and activity as indicators of compost stability and composting process evolution.

PubMed

Chroni, Christina; Kyriacou, Adamadini; Manios, Thrassyvoulos; Lasaridi, Konstantia-Ekaterini

2009-08-01

In a bid to identify suitable microbial indicators of compost stability, the process evolution during windrow composting of poultry manure (PM), green waste (GW) and biowaste was studied. Treatments were monitored with regard to abiotic factors, respiration activity (determined using the SOUR test) and functional microflora. The composting process went through typical changes in temperature, moisture content and microbial properties, despite the inherent feedstock differences. Nitrobacter and pathogen indicators varied as a monotonous function of processing time. Some microbial groups have shown a potential to serve as fingerprints of the different process stages, but still they should be examined in context with respirometric tests and abiotic parameters. Respiration activity reflected well the process stage, verifying the value of respirometric tests to access compost stability. SOUR values below 1 mg O(2)/g VS/h were achieved for the PM and the GW compost.

Interpretation bias and anxiety in childhood: stability, specificity and longitudinal associations.

PubMed

Creswell, Cathy; O'Connor, Thomas G

2011-03-01

Biases in the interpretation of ambiguous material are central to cognitive models of anxiety; however, understanding of the association between interpretation and anxiety in childhood is limited. To address this, a prospective investigation of the stability and specificity of anxious cognitions and anxiety and the relationship between these factors was conducted. Sixty-five children (10-11 years) from a community sample completed measures of self-reported anxiety, depression, and conduct problems, and responded to ambiguous stories at three time points over one-year. Individual differences in biases in interpretation of ambiguity (specifically "anticipated distress" and "threat interpretation") were stable over time. Furthermore, anticipated distress and threat interpretation were specifically associated with anxiety symptoms. Distress anticipation predicted change in anxiety symptoms over time. In contrast, anxiety scores predicted change in threat interpretation over time. The results suggest that different cognitive constructs may show different longitudinal links with anxiety. These preliminary findings extend research and theory on anxious cognitions and their link with anxiety in children, and suggest that these cognitive processes may be valuable targets for assessment and intervention.

Stability and maturity of biowaste composts derived by small municipalities: Correlation among physical, chemical and biological indices.

PubMed

Oviedo-Ocaña, E R; Torres-Lozada, P; Marmolejo-Rebellon, L F; Hoyos, L V; Gonzales, S; Barrena, R; Komilis, D; Sanchez, A

2015-10-01

Stability and maturity are important criteria to guarantee the quality of a compost that is applied to agriculture or used as amendment in degraded soils. Although different techniques exist to evaluate stability and maturity, the application of laboratory tests in municipalities in developing countries can be limited due to cost and application complexities. In the composting facilities of such places, some classical low cost on-site tests to monitor the composting process are usually implemented; however, such tests do not necessarily clearly identify conditions of stability and maturity. In this article, we have applied and compared results of stability and maturity tests that can be easily employed on site (i.e. temperature, pH, moisture, electrical conductivity [EC], odor and color), and of tests that require more complex laboratory techniques (volatile solids, C/N ratio, self-heating, respirometric index, germination index [GI]). The evaluation of the above was performed in the field scale using 2 piles of biowaste applied compost. The monitoring period was from day 70 to day 190 of the process. Results showed that the low-cost tests traditionally employed to monitor the composting process on-site, such as temperature, color and moisture, do not provide consistent determinations with the more complex laboratory tests used to assess stability (e.g. respiration index, self-heating, volatile solids). In the case of maturity tests (GI, pH, EC), both the on-site tests (pH, EC) and the laboratory test (GI) provided consistent results. Although, stability was indicated for most of the samples, the maturity tests indicated that products were consistently immature. Thus, a stable product is not necessarily mature. Conclusively, the decision on the quality of the compost in the installations located in developing countries requires the simultaneous use of a combination of tests that are performed both in the laboratory and on-site. Copyright © 2015 Elsevier Ltd. All

Reliability and Construct Validity of Limits of Stability Test in Adolescents Using a Portable Forceplate System.

PubMed

Alsalaheen, Bara; Haines, Jamie; Yorke, Amy; Broglio, Steven P

2015-12-01

To examine the reliability, convergent, and discriminant validity of the limits of stability (LOS) test to assess dynamic postural stability in adolescents using a portable forceplate system. Cross-sectional reliability observational study. School setting. Adolescents (N=36) completed all measures during the first session. To examine the reliability of the LOS test, a subset of 15 participants repeated the LOS test after 1 week. Not applicable. Outcome measurements included the LOS test, Balance Error Scoring System, Instrumented Balance Error Scoring System, and Modified Clinical Test for Sensory Interaction on Balance. A significant relation was observed among LOS composite scores (r=.36-.87, P<.05). However, no relation was observed between LOS and static balance outcome measurements. The reliability of the LOS composite scores ranged from moderate to good (intraclass correlation coefficient model 2,1=.73-.96). The results suggest that the LOS composite scores provide unique information about dynamic postural stability, and the LOS test completed at 100% of the theoretical limit appeared to be a reliable test of dynamic postural stability in adolescents. Clinicians should use dynamic balance measurement as part of their balance assessment and should not use static balance testing (eg, Balance Error Scoring System) to make inferences about dynamic balance, especially when balance assessment is used to determine rehabilitation outcomes, or when making return to play decisions after injury. Copyright © 2015 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

The nucleolar ubiquitin-specific protease USP36 deubiquitinates and stabilizes c-Myc

PubMed Central

Sun, Xiao-Xin; He, Xia; Yin, Li; Komada, Masayuki; Sears, Rosalie C.; Dai, Mu-Shui

2015-01-01

c-Myc protein stability and activity are tightly regulated by the ubiquitin-proteasome system. Aberrant stabilization of c-Myc contributes to many human cancers. c-Myc is ubiquitinated by SCFFbw7 (a SKP1-cullin-1-F-box complex that contains the F-box and WD repeat domain-containing 7, Fbw7, as the F-box protein) and several other ubiquitin ligases, whereas it is deubiquitinated and stabilized by ubiquitin-specific protease (USP) 28. The bulk of c-Myc degradation appears to occur in the nucleolus. However, whether c-Myc is regulated by deubiquitination in the nucleolus is not known. Here, we report that the nucleolar deubiquitinating enzyme USP36 is a novel c-Myc deubiquitinase. USP36 interacts with and deubiquitinates c-Myc in cells and in vitro, leading to the stabilization of c-Myc. This USP36 regulation of c-Myc occurs in the nucleolus. Interestingly, USP36 interacts with the nucleolar Fbw7γ but not the nucleoplasmic Fbw7α. However, it abolished c-Myc degradation mediated both by Fbw7γ and by Fbw7α. Consistently, knockdown of USP36 reduces the levels of c-Myc and suppresses cell proliferation. We further show that USP36 itself is a c-Myc target gene, suggesting that USP36 and c-Myc form a positive feedback regulatory loop. High expression levels of USP36 are found in a subset of human breast and lung cancers. Altogether, these results identified USP36 as a crucial and bono fide deubiquitinating enzyme controlling c-Myc’s nucleolar degradation pathway. PMID:25775507

Demography of Principals' Work and School Improvement: Content Validity of Kentucky's Standards and Indicators for School Improvement (SISI)

ERIC Educational Resources Information Center

Lindle, Jane Clark; Stalion, Nancy; Young, Lu

2005-01-01

Kentucky's accountability system includes a school-processes audit known as Standards and Indicators for School Improvement (SISI), which is in a nascent stage of validation. Content validity methods include comparison to instruments measuring similar constructs as well as other techniques such as job analysis. This study used a two-phase process…

Physics validation for design change of KSTAR passive stabilizer

NASA Astrophysics Data System (ADS)

Jeon, Y. M.; Kim, J. Y.; Oh, Y. K.; Yang, H. L.; Kim, W. C.; Kim, H. K.; Sabbagh, S. A.; Bialek, J. M.; Humphreys, D. A.; Welander, A. S.; Walker, M. L.

2009-11-01

Recently, the design of the passive stabilizer in KSTAR has been changed to improve controllability of the active control system and reduce the possibility of producing an additional error field. Originally the passive stabilizer in KSTAR was designed for RWM and vertical instability (or VDE) stabilizations and plasma startup efficiency, so that current bridges were designed and combined through 3D saddle-loop connections. Since the key design change is removing the current bridges, it's essential to assure satisfactory control performance for these instabilities under the design change. Control capability for n=1 RWM and achievable βN will be addressed as a primary goal of the passive stabilizer together with vertical instability control and effects on plasma startup. In addition, the changes in electro-magnetic force on conducting structures will be discussed qualitatively as a key engineering issue of the design change.

Development and validation of a stability-indicating HPLC-UV method for the determination of triamcinolone acetonide and its degradation products in an ointment formulation.

PubMed

van Heugten, A J P; de Boer, W; de Vries, W S; Markesteijn, C M A; Vromans, H

2018-02-05

A stability indicating high performance liquid chromatography method has been developed for the determination of triamcinolone acetonide (TCA) and its main degradation products in ointment formulations. The method, based on extensive stress testing using metal salts, azobisisobutyronitrile, acid, base and peroxide, showed that TCA undergoes oxidative degradation. All degradation products were identified using HPLC mass spectrometry. Separation and quantification was achieved using an Altima C18 RP18 HP column (250×4.6mm 2 , with 5μm particles) using a mobile phase consisting of acetonitrile and water buffered at pH 7 using 10mM phosphate buffer. A gradient mode was operated at a flow rate of 1.5ml/min and detection was at 241nm. The method showed linearity for TCA and Impurity C in 0.02-125% of the workload, both square roots of the correlation coefficients were larger than 0.9999. Repeatability and intermediate precision were performed by six consecutive injections of both 1.25% and 125% of the work load for both TCA and Impurity C divided equally over two days. RSD were 0.6% and 0.7% for TCA and 0.5% and 0.1% for Impurity C respectively. Accuracy was determined as well, the average recoveries were 99.5% (±0.1%, n=3) for TCA and 96.9% (±1.3%, n=3) for impurity C respectively from spiked ointment samples. The robustness was also evaluated by variations of column (old vs new), mobile phase pH and filter retention. The applicability of the method was evaluated by analysis of a commercial ointment formulation. Interestingly, the extensive stress tests were able to predict all degradation products of TCA in a long term stability ointment sample. Copyright © 2017 Elsevier B.V. All rights reserved.

Analysis of Urine as Indicators of Specific Body Conditions

NASA Astrophysics Data System (ADS)

Dey, Souradeep; Saha, Triya; Narendrakumar, Uttamchand

2017-11-01

Urinalysis can be defined as a procedure for examining various factors of urine, which include physical properties, particulate matter, cells, casts, crystals, organisms and solutes. Urinalysis is recommended to be a part of the initial examination of all patients as its cheap, feasible and gives productive results. This paper focuses on the analysis of urine collected at specific body conditions. Here we illustrate the urine profile of different persons having various body conditions, which include, having urinary tract infection, undergoing strenuous exercise, having back pain regularly, having very low urine output and a person who is on 24 hours of diet. Examination of urine collected from different persons having specific body conditions usually helps us in the diagnosis of various diseases, which it indicates.

Stability of physical assessment of older drivers over 1 year.

PubMed

Smith, Andrew; Marshall, Shawn; Porter, Michelle; Ha, Linda; Bédard, Michel; Gélinas, Isabelle; Man-Son-Hing, Malcolm; Mazer, Barbara; Rapoport, Mark; Tuokko, Holly; Vrkljan, Brenda

2013-12-01

Older adults represent the fastest-growing population of drivers with a valid driver's licence. Also common in this age group are multiple chronic medical conditions that may have an effect on physical function and driving ability. Determining the reliability of physical measures used to assess older drivers' functional ability is important to identifying those who are safe to continue driving. Most previous reliability studies of clinical physical measures of health used test-retest intervals shorter than those between patient visits with a clinician. In the present study we examined a more clinically representative interval of 1 year to determine the stability of commonly used physical measures collected during the Candrive II prospective cohort study of older drivers. Reliability statistics indicate that the sequential finger-thumb opposition, rapid pace walk and the Pelli-Robson contrast sensitivity tests have adequate stability over 1 year. Poor stability was observed for the one-legged stance and Snellen visual acuity test. Several assessments with nominal data (Marottoli method [functional neck range of motion], whispered voice test, range of motion and strength testing) lacked sufficient variability to conduct reliability analyses; however, a lack of variability between test days suggests consistency over a 1-year time frame. Our results provide evidence that specific physical measures are stable in monitoring functional ability over the course of a year. Copyright © 2013 Elsevier Ltd. All rights reserved.

Human active X-specific DNA methylation events showing stability across time and tissues

PubMed Central

Joo, Jihoon Eric; Novakovic, Boris; Cruickshank, Mark; Doyle, Lex W; Craig, Jeffrey M; Saffery, Richard

2014-01-01

The phenomenon of X chromosome inactivation in female mammals is well characterised and remains the archetypal example of dosage compensation via monoallelic expression. The temporal series of events that culminates in inactive X-specific gene silencing by DNA methylation has revealed a ‘patchwork' of gene inactivation along the chromosome, with approximately 15% of genes escaping. Such genes are therefore potentially subject to sex-specific imbalance between males and females. Aside from XIST, the non-coding RNA on the X chromosome destined to be inactivated, very little is known about the extent of loci that may be selectively silenced on the active X chromosome (Xa). Using longitudinal array-based DNA methylation profiling of two human tissues, we have identified specific and widespread active X-specific DNA methylation showing stability over time and across tissues of disparate origin. Our panel of X-chromosome loci subject to methylation on Xa reflects a potentially novel mechanism for controlling female-specific X inactivation and sex-specific dimorphisms in humans. Further work is needed to investigate these phenomena. PMID:24713664

Validity of a basketball-specific complex test in female professional players.

PubMed

Schwesig, René; Hermassi, Souhail; Lauenroth, Andreas; Laudner, Kevin; Koke, Alexander; Bartels, Thomas; Delank, Stefan; Schulze, Stephan

2018-06-01

The purpose of this study was to assess the validity of a new basketball-specific complex test (BBCT) based on the ascertained match performance.Fourteen female professional basketball players (ages: 23.4 ± 1.8 years) performed the BBCT and a treadmill test (TT) at the beginning of pre-season training. Lactate, heart rate (HR), time, shooting precision and number of errors were measured during the four test sequences of the BBCT (short distance sprinting with direction changes, with and without a ball; fast break; lay-up parcours; sprint endurance test). In addition, lactate threshold (LT) and HR were assessed at selected times throughout the TT and the BBCT and over 6 (TT) or 10 (BBCT) minutes after the tests. The match performance score (mps) was calculated on specific parameters (e. g. points) collected during all matches during the subsequent season (22 matches). The mps served as the "gold standard" within the validation process for the BBCT and the TT.TT parameters demonstrated an explained variance (EV) between 0 % (HR recovery) and 11 % (running speed at 6 mmol/l LT). The EV from the BBCT was higher and ranged from 0 % (HR recovery 6 minutes after end of exercise) to 28 % (sprint endurance test after 8 of 10 sprints). Ten out of 21 BBCT parameters (48 %) and 2 out of 5 TT parameters (40 %) demonstrated an EV higher than 10 %. Average EV for all parameters was 12 % (BBCT) and 6 % (TT), respectively. The BBCT had a higher validity than the TT for predicting match performance. These findings suggest that coaches and scientists should consider using the BBCT testing protocol to estimate the match performance abilities of elite female players. © Georg Thieme Verlag KG Stuttgart · New York.

Stability-Indicating TLC-Densitometric and HPLC Methods for the Simultaneous Determination of Piracetam and Vincamine in the Presence of Their Degradation Products.

PubMed

Ahmed, Amal B; Abdelrahman, Maha M; Abdelwahab, Nada S; Salama, Fathy M

2016-11-01

Newly established TLC-densitometric and RP-HPLC methods were developed and validated for the simultaneous determination of Piracetam (PIR) and Vincamine (VINC) in their pharmaceutical formulation and in the presence of PIR and VINC degradation products, PD and VD, respectively. The proposed TLC-densitometric method is based on the separation and quantitation of the studied components using a developing system that consists of chloroform-methanol-glacial acetic acid-triethylamine (8 + 2 + 0.1 + 0.1, v/v/v/v) on TLC silica gel 60 F254 plates, followed by densitometric scanning at 230 nm. On the other hand, the developed RP-HPLC method is based on the separation of the studied components using an isocratic elution of 0.05 M KH2PO4 (containing 0.1% triethylamine adjusted to pH 3 with orthophosphoric acid)-methanol (95 + 5, v/v) on a C8 column at a flow rate of 1 mL/min with diode-array detection at 230 nm. The developed methods were validated according to International Conference on Harmonization guidelines and demonstrated good accuracy and precision. Moreover, the developed TLC-densitometric and RP-HPLC methods are suitable as stability-indicating assay methods for the simultaneous determination of PD and VD either in bulk powder or pharmaceutical formulation. The results were statistically compared with those obtained by the reported RP-HPLC method using t- and F-tests.

Development and Validation of Videotaped Scenarios: A Method for Targeting Specific Participant Groups

ERIC Educational Resources Information Center

Noel, Nora E.; Maisto, Stephen A.; Johnson, James D.; Jackson, Lee A., Jr.; Goings, Christopher D.; Hagman, Brett T.

2008-01-01

Researchers using scenarios often neglect to validate perceived content and salience of embedded stimuli specifically with intended participants, even when such meaning is integral to the study. For example, sex and aggression stimuli are heavily influenced by culture, so participants may not perceive what researchers intended in sexual aggression…

Determination of thermal stability of specific biomarker lipids of the freshwater fern Azolla through hydrous pyrolysis

NASA Astrophysics Data System (ADS)

Sap, Merel; Speelman, Eveline N.; Lewan, Michael D.; Sinninghe Damsté, Jaap S.; Reichart, Gert-Jan

2010-05-01

Enormous blooms of the free-floating freshwater fern Azolla occurred within the Arctic Basin during an extended period of ~1.2 Ma during the middle Eocene (Brinkhuis et al. 2006; Speelman et al., GB, 2009). The sustained growth of Azolla, currently ranking among the fastest growing plants on Earth, in a major anoxic basin may have substantially contributed to decreasing atmospheric CO2 levels by burial of Azolla-derived organic matter. Speelman et al. (OG, 2009) reported biomarkers for Azolla (1,w20 C32 - C36 diols, structurally related C29 ω20,ω21 diols, C29 1,20,21 triols, C29 dihydroxy fatty acids as well as a series of wax esters containing these mono- and dihydroxy lipids), which can be used to reconstruct palaeo-environmental conditions. Here we assess the thermal stability of these compounds, to extend their biomarker potential. We specifically focused on the thermal stability of the Azolla biomarkers using hydrous pyrolysis in order to determine which burial conditions allow reconstruction of past occurrences of Azolla. In addition, hydrous pyrolysis was also performed on samples from the Eocene Arctic Ocean (ACEX core), to test if and how the biomarkers change under higher temperatures and pressures in situ. During hydrous pyrolysis, the biomass was heated under high pressure at temperatures ranging between 220 and 365°C for 72 hours. Four experiments were also run using different durations to explore the kinetics of biomarker degradation at specific temperatures. First results indicate that the Azolla specific diols are still present at 220°C, while the corresponding wax esters are already absent. At 300°C all Azolla specific biomarkers are destroyed. More specific determination of the different biomarkers' stability and kinetics would potentially allow the reconstruction of the temperature and pressure history of Azolla deposits. Literature: • Brinkhuis, H., Schouten, S., Collinson, M. E., Sluijs, A., Sinninghe Damste, J. S., Dickens, G. R., Huber

Reliability and validity of Arabic translation of Medication Adherence Report Scale (MARS) and Beliefs about Medication Questionnaire (BMQ)-specific for use in children and their parents.

PubMed

Alsous, Mervat; Alhalaiqa, Fadwa; Abu Farha, Rana; Abdel Jalil, Mariam; McElnay, James; Horne, Robert

2017-01-01

to evaluate the reliability and discriminant validity of Arabic translation of the Medication Adherence Report Scale (MARS) and the Beliefs about Medication Questionnaire-specific (BMQ-specific). Having developed Arabic translations of the study instruments, a cross-sectional study was carried out between March and October 2015 in two multidisciplinary governmental hospitals in Jordan. An expert panel monitored the forward and backward translation of the MARS and BMQ. Standard Arabic was used (with no specific dialect inclusion) to allow greater generalisability across Arabic speaking countries. Once the Arabic translations of the questionnaires were developed they were tested for consistency, validity and reliability on a group of children with chronic diseases and their parents. A total of 258 parents and 208 children were included in the study. The median age of participated children and parents was 15 years and 42 years respectively. Principle component analysis of all questionnaires indicated that all had good construct validity as they clearly measured one construct. The questionnaires were deemed reliable based on the results of Cronbach alpha coefficient. Furthermore, reliability of the questionnaires was demonstrated by test-retest intraclass correlation coefficients (ICC) which ranged from good to excellent for all scales (ICC>0.706). The Pearson correlation coefficient ranged from 0.546-0.805 for the entire sample which indicated a significant moderate to strong positive correlation between MARS and BMQ items at time 1 and 2. Reported adherence was greater than 59% using MARS-children and MARS-parents scales, and was correlated with beliefs in necessity and independent of the concerns regarding medications. The Arabic translations of both BMQ and MARS for use in children and their parents have good internal consistency and proved to be valid and reliable tools that can be used by researchers in clinical practice to measure adherence and beliefs about

Specific and social fears in children and adolescents: separating normative fears from problem indicators and phobias.

PubMed

Laporte, Paola P; Pan, Pedro M; Hoffmann, Mauricio S; Wakschlag, Lauren S; Rohde, Luis A; Miguel, Euripedes C; Pine, Daniel S; Manfro, Gisele G; Salum, Giovanni A

2017-01-01

To distinguish normative fears from problematic fears and phobias. We investigated 2,512 children and adolescents from a large community school-based study, the High Risk Study for Psychiatric Disorders. Parent reports of 18 fears and psychiatric diagnosis were investigated. We used two analytical approaches: confirmatory factor analysis (CFA)/item response theory (IRT) and nonparametric receiver operating characteristic (ROC) curve. According to IRT and ROC analyses, social fears are more likely to indicate problems and phobias than specific fears. Most specific fears were normative when mild; all specific fears indicate problems when pervasive. In addition, the situational fear of toilets and people who look unusual were highly indicative of specific phobia. Among social fears, those not restricted to performance and fear of writing in front of others indicate problems when mild. All social fears indicate problems and are highly indicative of social phobia when pervasive. These preliminary findings provide guidance for clinicians and researchers to determine the boundaries that separate normative fears from problem indicators in children and adolescents, and indicate a differential severity threshold for specific and social fears.

Thyroid-specific questions on work ability showed known-groups validity among Danes with thyroid diseases.

PubMed

Nexo, Mette Andersen; Watt, Torquil; Bonnema, Steen Joop; Hegedüs, Laszlo; Rasmussen, Åse Krogh; Feldt-Rasmussen, Ulla; Bjorner, Jakob Bue

2015-07-01

We aimed to identify the best approach to work ability assessment in patients with thyroid disease by evaluating the factor structure, measurement equivalence, known-groups validity, and predictive validity of a broad set of work ability items. Based on the literature and interviews with thyroid patients, 24 work ability items were selected from previous questionnaires, revised, or developed anew. Items were tested among 632 patients with thyroid disease (non-toxic goiter, toxic nodular goiter, Graves' disease (with or without orbitopathy), autoimmune hypothyroidism, and other thyroid diseases), 391 of which had participated in a study 5 years previously. Responses to select items were compared to general population data. We used confirmatory factor analyses for categorical data, logistic regression analyses and tests of differential item function, and head-to-head comparisons of relative validity in distinguishing known groups. Although all work ability items loaded on a common factor, the optimal factor solution included five factors: role physical, role emotional, thyroid-specific limitations, work limitations (without disease attribution), and work performance. The scale on thyroid-specific limitations showed the most power in distinguishing clinical groups and time since diagnosis. A global single item proved useful for comparisons with the general population, and a thyroid-specific item predicted labor market exclusion within the next 5 years (OR 5.0, 95 % CI 2.7-9.1). Items on work limitations with attribution to thyroid disease were most effective in detecting impact on work ability and showed good predictive validity. Generic work ability items remain useful for general population comparisons.

Facultative Stabilization Pond: Measuring Biological Oxygen Demand using Mathematical Approaches

NASA Astrophysics Data System (ADS)

Wira S, Ihsan; Sunarsih, Sunarsih

2018-02-01

Pollution is a man-made phenomenon. Some pollutants which discharged directly to the environment could create serious pollution problems. Untreated wastewater will cause contamination and even pollution on the water body. Biological Oxygen Demand (BOD) is the amount of oxygen required for the oxidation by bacteria. The higher the BOD concentration, the greater the organic matter would be. The purpose of this study was to predict the value of BOD contained in wastewater. Mathematical modeling methods were chosen in this study to depict and predict the BOD values contained in facultative wastewater stabilization ponds. Measurements of sampling data were carried out to validate the model. The results of this study indicated that a mathematical approach can be applied to predict the BOD contained in the facultative wastewater stabilization ponds. The model was validated using Absolute Means Error with 10% tolerance limit, and AME for model was 7.38% (< 10%), so the model is valid. Furthermore, a mathematical approach can also be applied to illustrate and predict the contents of wastewater.

Experimental and theoretical studies of the colloidal stability of nanoparticles-a general interpretation based on stability maps.

PubMed

Segets, Doris; Marczak, Renata; Schäfer, Stefan; Paula, Carolin; Gnichwitz, Jan-Frederik; Hirsch, Andreas; Peukert, Wolfgang

2011-06-28

The current work addresses the understanding of the stabilization of nanoparticles in suspension. Specifically, we study ZnO in ethanol for which the influence of particle size and reactant ratio as well as surface coverage on colloidal stability in dependence of the purification progress was investigated. The results revealed that the well-known ζ-potential determines not only the colloidal stability but also the surface coverage of acetate groups bound to the particle surface. The acetate groups act as molecular spacers between the nanoparticles and prevent agglomeration. Next to DLVO calculations based on the theory of Derjaguin, Landau, Verwey and Overbeek using a core-shell model we find that the stability is better understood in terms of dimensionless numbers which represent attractive forces as well as electrostatic repulsion, steric effects, transport properties, and particle concentration. Evaluating the colloidal stability in dependence of time by means of UV-vis absorption measurements a stability map for ZnO is derived. From this map it becomes clear that the dimensionless steric contribution to colloidal stability scales with a stability parameter including dimensionless repulsion and attraction as well as particle concentration and diffusivity of the particles according to a power law with an exponent of -0.5. Finally, we show that our approach is valid for other stabilizing molecules like cationic dendrons and is generally applicable for a wide range of other material systems within the limitations of vanishing van der Waals forces in refractive index matched situations, vanishing ζ-potential and systems without a stabilizing shell around the particle surface.

flowVS: channel-specific variance stabilization in flow cytometry.

PubMed

Azad, Ariful; Rajwa, Bartek; Pothen, Alex

2016-07-28

Comparing phenotypes of heterogeneous cell populations from multiple biological conditions is at the heart of scientific discovery based on flow cytometry (FC). When the biological signal is measured by the average expression of a biomarker, standard statistical methods require that variance be approximately stabilized in populations to be compared. Since the mean and variance of a cell population are often correlated in fluorescence-based FC measurements, a preprocessing step is needed to stabilize the within-population variances. We present a variance-stabilization algorithm, called flowVS, that removes the mean-variance correlations from cell populations identified in each fluorescence channel. flowVS transforms each channel from all samples of a data set by the inverse hyperbolic sine (asinh) transformation. For each channel, the parameters of the transformation are optimally selected by Bartlett's likelihood-ratio test so that the populations attain homogeneous variances. The optimum parameters are then used to transform the corresponding channels in every sample. flowVS is therefore an explicit variance-stabilization method that stabilizes within-population variances in each channel by evaluating the homoskedasticity of clusters with a likelihood-ratio test. With two publicly available datasets, we show that flowVS removes the mean-variance dependence from raw FC data and makes the within-population variance relatively homogeneous. We demonstrate that alternative transformation techniques such as flowTrans, flowScape, logicle, and FCSTrans might not stabilize variance. Besides flow cytometry, flowVS can also be applied to stabilize variance in microarray data. With a publicly available data set we demonstrate that flowVS performs as well as the VSN software, a state-of-the-art approach developed for microarrays. The homogeneity of variance in cell populations across FC samples is desirable when extracting features uniformly and comparing cell populations with

Validation of nomograms for overall survival, cancer-specific survival, and recurrence in carcinoma of the major salivary glands.

PubMed

Hay, Ashley; Migliacci, Jocelyn; Zanoni, Daniella Karassawa; Patel, Snehal; Yu, Changhong; Kattan, Michael W; Ganly, Ian

2018-05-01

The purpose of this study was to investigate the performance of the Memorial Sloan Kettering Cancer Center salivary carcinoma nomograms predicting overall survival, cancer-specific survival, and recurrence with an external validation dataset. The validation dataset comprised 123 patients treated between 2010 and 2015 at our institution. They were evaluated by assessing discrimination (concordance index [C-index]) and calibration (plotting predicted vs actual probabilities for quintiles). The validation cohort (n = 123) showed some differences to the original cohort (n = 301). The validation cohort had less high-grade cancers (P = .006), less lymphovascular invasion (LVI; P < .001) and shorter follow-up of 19 months versus 45.6 months. Validation showed a C-index of 0.833 (95% confidence interval [CI] 0.758-0.908), 0.807 (95% CI 0.717-0.898), and 0.844 (95% CI 0.768-0.920) for overall survival, cancer-specific survival, and recurrence, respectively. The 3 salivary gland nomograms performed well using a contemporary validation dataset, despite limitations related to sample size, follow-up, and differences in clinical and pathology characteristics between the original and validation cohorts. © 2018 Wiley Periodicals, Inc.

Development of a stability-indicating CE assay for the determination of amlodipine enantiomers in commercial tablets.

PubMed

Fakhari, Ali Reza; Nojavan, Saeed; Haghgoo, Soheila; Mohammadi, Ali

2008-11-01

A simple, accurate, precise and sensitive method using CD for separation and stability indicating assay of enantiomers of amlodipine in the commercial tablets has been established. Several types of CD were evaluated and best results were obtained using a fused-silica capillary with phosphate running buffer (100 mM, pH 3.0) containing 5 mM hydroxypropyl-alpha-CD. The method has shown adequate separation for amlodipine enantiomers from its degradation products. The drug was subjected to oxidation, hydrolysis, photolysis and heat to apply stress conditions. The range of quantitation for both enantiomers was 5-150 microg/mL. Intra- and inter-day RSD (n=6) was <4%. The limit of quantification that produced the requisite precision and accuracy was found to be 5 microg/mL for both enantiomers. The LOD for both enantiomers was found to be 0.5 microg/mL. Degradation products produced as a result of stress studies did not interfere with the detection of enantiomers and the assay can thus be considered stability indicating.

Stability indicating HPLC-UV method for detection of curcumin in Curcuma longa extract and emulsion formulation.

PubMed

Syed, Haroon Khalid; Liew, Kai Bin; Loh, Gabriel Onn Kit; Peh, Kok Khiang

2015-03-01

A stability-indicating HPLC-UV method for the determination of curcumin in Curcuma longa extract and emulsion was developed. The system suitability parameters, theoretical plates (N), tailing factor (T), capacity factor (K'), height equivalent of a theoretical plate (H) and resolution (Rs) were calculated. Stress degradation studies (acid, base, oxidation, heat and UV light) of curcumin were performed in emulsion. It was found that N>6500, T<1.1, K' was 2.68-3.75, HETP about 37 and Rs was 1.8. The method was linear from 2 to 200 μg/mL with a correlation coefficient of 0.9998. The intra-day precision and accuracy for curcumin were ⩽0.87% and ⩽2.0%, while the inter-day precision and accuracy values were ⩽2.1% and ⩽-1.92. Curcumin degraded in emulsion under acid, alkali and UV light. In conclusion, the stability-indicating method could be employed to determine curcumin in bulk and emulsions. Copyright © 2014 Elsevier Ltd. All rights reserved.

Stability of minoxidil in Espumil foam base.

PubMed

Geiger, Christine M; Sorenson, Bridget; Whaley, Paul A

2013-01-01

Minoxidil is a drug used to stimulate hair growth and to slow balding. It is marketed under a number of trade names, including Rogaine, and is available in varying strength dose forms from a number of generic manufacturers. Minoxidil is available in oral and topical forms. In topical form, it can be applied by a metered-spray or rub-on applicator. A hydroalcoholic compounding vehicle can minimize greasiness, itching, burning, and contact dermatitis where low concentrations of ethanol and propylene glycol are present. Espumil Foam Base contains low concentrations of these ingredients and also can form a foam on topical application. Espumil's unique delivery by foam-activating packaging assures simple application to difficult-to-treat areas, and it vanishes quickly after application, keeping it in place and avoiding health skin areas. The objective of this study was to determine the stability of minoxidil in Espumil Foam Base. The studied sample was compounded into a 50-mg/mL solution and stored in a plastic foam-activating bottle at room temperature conditions. Three samples were assayed at each time point out to 90 days by a stability-indicating high-performance liquid chromatography method. The method was validated for its specificity through forced-degradation studies. The beyond-use-date is at least 90 days, based on data collected when this formulation was stored at room temperature, protected from light.

Stability of Metronidazole Suspensions.

PubMed

Donnelly, Ronald F; Ying, James

2015-01-01

Metronidazole is an antiprotozoal agent used in the treatment of bacterial and protozoal anaerobic infections. The objectives of this study were to develop concentrated metronidazole suspensions that are inexpensive and easy to prepare and determine the stability of these suspensions after storage in amber polyvinyl chloride bottles at room temperature (23°C) and under refrigeration (5°C). Metronidazole suspensions (50 mg/mL) were prepared from powder using Ora-Blend or simple syrup as the vehicles. Samples were collected in triplicate from each container on days 0, 7, 14, 28, 56, and 93. Samples were assayed using a high-performance liquid chromatography method that had been validated as stability indicating. Color, change in physical appearance, and pH were also monitored at each time interval. There was no apparent change in color or physical appearance. The pH values changed by less than 0.20 units over the 93 days. The stability of metronidazole suspensions compounded from United States Pharmacopeia powder using Ora-Blend or simple syrup and packaged in amber polyvinyl chloride bottles was determined to be 93 days when stored at either room temperature or under refrigeration.

On the validity of the modified equation approach to the stability analysis of finite-difference methods

NASA Technical Reports Server (NTRS)

Chang, Sin-Chung

1987-01-01

The validity of the modified equation stability analysis introduced by Warming and Hyett was investigated. It is shown that the procedure used in the derivation of the modified equation is flawed and generally leads to invalid results. Moreover, the interpretation of the modified equation as the exact partial differential equation solved by a finite-difference method generally cannot be justified even if spatial periodicity is assumed. For a two-level scheme, due to a series of mathematical quirks, the connection between the modified equation approach and the von Neuman method established by Warming and Hyett turns out to be correct despite its questionable original derivation. However, this connection is only partially valid for a scheme involving more than two time levels. In the von Neumann analysis, the complex error multiplication factor associated with a wave number generally has (L-1) roots for an L-level scheme. It is shown that the modified equation provides information about only one of these roots.

Fitness-Specific Epistemic Beliefs, Effort Regulation, Outcomes, and Indices of Motivation in High School Physical Education

ERIC Educational Resources Information Center

Lodewyk, Ken R.; Gao, Zan

2013-01-01

Epistemic beliefs are deeply held convictions about the nature of knowledge, knowing, and learning. In this study, approximately 500 ninth and tenth-grade physical education (PE) students completed fitness-specific measures assessing their epistemic beliefs in the simplicity and stability of knowledge and the speed of its acquisition along with…

Validation results of specifications for motion control interoperability

NASA Astrophysics Data System (ADS)

Szabo, Sandor; Proctor, Frederick M.

1997-01-01

The National Institute of Standards and Technology (NIST) is participating in the Department of Energy Technologies Enabling Agile Manufacturing (TEAM) program to establish interface standards for machine tool, robot, and coordinate measuring machine controllers. At NIST, the focus is to validate potential application programming interfaces (APIs) that make it possible to exchange machine controller components with a minimal impact on the rest of the system. This validation is taking place in the enhanced machine controller (EMC) consortium and is in cooperation with users and vendors of motion control equipment. An area of interest is motion control, including closed-loop control of individual axes and coordinated path planning. Initial tests of the motion control APIs are complete. The APIs were implemented on two commercial motion control boards that run on two different machine tools. The results for a baseline set of APIs look promising, but several issues were raised. These include resolving differing approaches in how motions are programmed and defining a standard measurement of performance for motion control. This paper starts with a summary of the process used in developing a set of specifications for motion control interoperability. Next, the EMC architecture and its classification of motion control APIs into two classes, Servo Control and Trajectory Planning, are reviewed. Selected APIs are presented to explain the basic functionality and some of the major issues involved in porting the APIs to other motion controllers. The paper concludes with a summary of the main issues and ways to continue the standards process.

Reliability and Validity of the Hip Stability Isometric Test (HipSIT): A New Method to Assess Hip Posterolateral Muscle Strength.

PubMed

Almeida, Gabriel Peixoto Leão; das Neves Rodrigues, Helena Larissa; de Freitas, Bruno Wesley; de Paula Lima, Pedro Olavo

2017-12-01

Study Design Cross-sectional study. Background The Hip Stability Isometric Test (HipSIT) evaluates the strength of the hip posterolateral stabilizers in a position that favors greater activation of the gluteus maximus and gluteus medius and lower activation of the tensor fascia lata. Objectives To check the validity and reliability of the HipSIT and to evaluate the HipSIT in women with patellofemoral pain (PFP). Methods The HipSIT was evaluated with a handheld dynamometer. During testing, the participants were sidelying, with their legs positioned at 45° of hip flexion and 90° of knee flexion. Participants were instructed to raise the knee of the upper leg while keeping the upper and lower heels in contact. To establish reliability and validity, 49 women were tested with the HipSIT by 2 different evaluators on day 1, and then again 7 days later. The strength of the hip extensors, abductors, and external rotators was also evaluated. Twenty women with unilateral PFP were also evaluated. Results The HipSIT has excellent intrarater and interrater reliability. The standard error of measurement was 0.01 kgf/kg, and the minimal detectable change was 0.036 kgf/kg. The HipSIT showed good validity in isolated hip abduction, external rotation, and extension (P<.01). Women with PFP showed a 10% deficit in the HipSIT results for the symptomatic limb (P = .01). Conclusion The HipSIT showed excellent interrater and intrarater reliability, moderate to good validity in women, and was able to identify strength deficits in women with PFP. J Orthop Sports Phys Ther 2017;47(12):906-913. Epub 9 Oct 2017. doi:10.2519/jospt.2017.7274.

Length of stay after reaching clinical stability drives hospital costs associated with adult community-acquired pneumonia.

PubMed

Cortoos, Pieter-Jan; Gilissen, Christa; Laekeman, Gert; Peetermans, Willy E; Leenaers, Hilde; Vandorpe, Luc; Simoens, Steven

2013-03-01

Community-acquired pneumonia (CAP) has a considerable clinical and economic impact. The aim of this study was to identify drivers of hospital costs associated with CAP in 2 Belgian hospitals. Specifically, the influence of patient characteristics, quality indicators, and other treatment aspects on hospital costs was explored. The following were registered for patients admitted with a confirmed diagnosis of CAP in a large university hospital (Universitaire Ziekenhuizen Leuven, UZL) and a medium-sized secondary care hospital (Ziekenhuis Oost-Limburg, ZOL) in Belgium: the pneumonia severity index (PSI), time to clinical stability, length of stay, antibiotic therapy, outcomes, compliance with validated quality indicators, and the different costs (pharmacy, laboratory, and radiology, and total). Regression analysis was used to identify influential variables. Between October 2007 and June 2010, 803 patients were included, with a median total cost of €4794.57. The length of stay after clinical stability and time to clinical stability had the highest influence on the total cost (+6.3% and +4.9% per additional day, respectively; p < 0.0001). Other important drivers of higher costs were total therapy duration, PSI score, age, and admission to intensive care. Patients treated with moxifloxacin had significantly, but limited, lower costs. Quality indicator compliance, including guideline-compliant antibiotic treatment and therapy streamlining, had little influence. The most important driver of hospital costs associated with CAP was the time between clinical stability and actual hospital discharge. In order to substantially decrease the costs of CAP treatment, this period should be rigorously evaluated for possible intervention targets that would allow costs in CAP treatment to be decreased in a substantial manner.

Quality indicators and specifications for strategic and support processes in laboratory medicine.

PubMed

Ricós, Carmen; Biosca, Carme; Ibarz, Mercè; Minchinela, Joana; Llopis, Maantonia; Perich, Carmen; Alsina, Jesus; Alvarez, Virtudes; Doménech, Vicenta; Pastor, Rosa Ma; Sansalvador, Mireia; Isern, Gloria Trujillo; Navarro, Conrad Vilanova

2008-01-01

This work is the second part of a study regarding indicators and quality specifications for the non-analytical processes in laboratory medicine. Five primary care and five hospital laboratories agreed on the indicators for two strategic processes (quality planning and project development) and various support processes (client relationships, instrument and infrastructure maintenance, safety and risk prevention, purchases and storage, personnel training). In the majority of cases, the median values recorded over 1 year is considered to be the state-of-the-art in our setting and proposed as the quality specification for the indicators stated. Values have been stratified according to primary care and hospital laboratory for referred tests and group of personnel for training. In some cases, the specifications have been set equal to zero events, such as serious incidents in the infrastructure maintenance process and number of work accidents in the safety and risk prevention process. In light of this study, an effort is needed to optimize decisions regarding corrective actions and to move from a subjective individual criterion to systematic and comparative management. This preliminary study provides a comprehensive vision of a subject that could motivate further research and advances in the quality of laboratory services.

A four parameter optimization and troubleshooting of a RPLC - charged aerosol detection stability indicating method for determination of S-lysophosphatidylcholines in a phospholipid formulation.

PubMed

Tam, James; Ahmad, Imad A Haidar; Blasko, Andrei

2018-06-05

A four parameter optimization of a stability indicating method for non-chromophoric degradation products of 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), 1-stearoyl-sn-glycero-3-phosphocholine and 2-stearoyl-sn-glycero-3-phosphocholine was achieved using a reverse phase liquid chromatography-charged aerosol detection (RPLC-CAD) technique. Using the hydrophobic subtraction model of selectivity, a core-shell, polar embedded RPLC column was selected followed by gradient-temperature optimization, resulting in ideal relative peak placements for a robust, stability indicating separation. The CAD instrument parameters, power function value (PFV) and evaporator temperature were optimized for lysophosphatidylcholines to give UV absorbance detector-like linearity performance within a defined concentration range. The two lysophosphatidylcholines gave the same response factor in the selected conditions. System specific power function values needed to be set for the two RPLC-CAD instruments used. A custom flow-divert profile, sending only a portion of the column effluent to the detector, was necessary to mitigate detector response drifting effects. The importance of the PFV optimization for each instrument of identical build and how to overcome recovery issues brought on by the matrix effects from the lipid-RP stationary phase interaction is reported. Copyright © 2018 Elsevier B.V. All rights reserved.

Item analysis using Rasch models confirms that the Danish versions of the DISABKIDS® chronic-generic and diabetes-specific modules are valid and reliable.

PubMed

Nielsen, Julie Bøjstrup; Kyvsgaard, Julie Nyholm; Sildorf, Stine Møller; Kreiner, Svend; Svensson, Jannet

2017-03-01

Type 1 Diabetes (T1D) has a negative impact on psychological and overall well-being. Screening for Health-related Quality of Life (HrQoL) and addressing HrQoL issues in the clinic leads to improved well-being and metabolic outcomes. The aim of this study was to translate the generic and diabetes-specific validated multinational DISABKIDS® questionnaires into Danish, and then determine their validity and reliability. The questionnaires were translated using a validated translation procedure and completed by 99 children and adolescents from our diabetes-department; all diagnosed with T1D and were aged between 8 and 18 years old. The Rasch and the graphical log linear Rasch model (GLLRM) were used to determine validity. Monte Carlo methods and Cronbach's α were used to confirm reliability. The data did not fit a pure Rasch model but did fit a GLLRM when item six in the independence scale is excluded. The six subscales measure different aspects of HrQoL indicating that all the subscales are necessary. The questionnaire shows local dependency between items and differential item functioning (DIF). Therefore age, gender, and glycated hemoglobin (HbA1c) levels must be taken into account when comparing HrQoL between groups. The Danish versions of the DISABKIDS® chronic-generic and diabetes-specific modules provide valid and objective measurements with adequate reliability. These Danish versions are useful tools for evaluating HrQoL in Danish patients with T1D. However, guidelines on how to manage DIF and local independence will be required, and item six should be rephrased.

Postural stability of biped robots and the foot-rotation indicator (FRI) point

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

Goswami, A.

1999-06-01

The focus of this paper is the problem of foot rotation in biped robots during the single-support phase. Foot rotation is an indication of postural instability, which should be carefully treated in a dynamically stable walk and avoided altogether in a statically stable walk. The author introduces the foot-rotation indicator (FRI) point, which is a point on the foot/ground-contact surface where the net ground-reaction force would have to act to keep the foot stationary. To ensure no foot rotation, the FRI point must remain within the convex hull of the foot-support area. In contrast with the ground projection of themore » center of mass (GCoM), which is a static criterion, the FRI point incorporates robot dynamics. As opposed to the center of pressure (CoP) -- better known as the zero-moment point (ZMP) in the robotics literature -- which may not leave the support area, the FRI point may leave the area. In fact, the position of the FRI point outside the footprint indicates the direction of the impending rotation and the magnitude of rotational moment acting on the foot. Owing to these important properties, the FRI point helps not only to monitor the state of postural stability of a biped robot during the entire gait cycle, but indicates the severity of instability of the gait as well. In response to a recent need, the paper also resolves the misconceptions surrounding the CoP/ZMP equivalence.« less

Development and validation of a cancer-specific swallowing assessment tool: MASA-C.

PubMed

Carnaby, Giselle D; Crary, Michael A

2014-03-01

We present data from a sample of patients receiving radiotherapy for head/neck cancer to define and measure the validity of a new clinical assessment measure for swallowing. Fifty-eight patients undergoing radiotherapy (±chemotherapy) for head/neck cancer (HNC) supported the development of a physiology-based assessment tool of swallowing (Mann Assessment of Swallowing Ability--Cancer: MASA-C) administered at two time points (baseline and following radiotherapy treatment). The new exam was evaluated for internal consistency of items using Cronbach's alpha. Reliability of measurement was evaluated with intraclass correlation (ICC) and the Kappa statistic between two independent raters. Concurrent validity was established through comparison with the original MASA examination and against the referent standard videofluoroscopic swallowing examination (VFE). Sensitivity, specificity, and likelihood ratios along with 95 % confidence intervals (CIs) were derived for comparison of the two evaluation forms (MASA vs. MASA-C). Accuracy of diagnostic precision was displayed using receiver operator characteristic curves. The new MASA-C tool demonstrated superior validity to the original MASA examination applied to a HNC population. In comparison to the VFE referent exam, the MASA-C revealed strong sensitivity and specificity (Se 83, Sp 96), predictive values (positive predictive value (PPV) 0.95, negative predictive value (NPV) 0.86), and likelihood ratios (21.6). In addition, it demonstrated good reliability (ICC = 0.96) between speech-language pathology raters. The MASA-C is a reliable and valid scale that is sensitive to differences in swallowing performance in HNC patients with and without dysphagia. Future longitudinal evaluation of this tool in larger samples is suggested. The development and refinement of this swallowing assessment tool for use in multidisciplinary HNC teams will facilitate earlier identification of patients with swallowing difficulties and enable

Development and application of a validated stability-indicating HPLC method for simultaneous determination of granisetron hydrochloride, benzyl alcohol and their main degradation products in parenteral dosage forms.

PubMed

Hewala, Ismail; El-Fatatre, Hamed; Emam, Ehab; Mubrouk, Mokhtar

2010-06-30

A simple, rapid and sensitive reversed phase high performance liquid chromatographic method using photodiode array detection was developed and validated for the simultaneous determination of granisetron hydrochloride, benzyl alcohol, 1-methyl-1H-indazole-3-carboxylic acid (the main degradation product of granisetron) and benzaldehyde (the main degradation product of benzyl alcohol) in granisetron injections. The separation was achieved on Hypersil BDS C8 (250 mm x 4.6 mm i.d., 5 microm particle diameter) column using a mobile phase consisted of acetonitrile:0.05 M KH(2)PO(4):triethylamine (22:100:0.15) adjusted to pH 4.8. The column was maintained at 25 degrees C and 20 microL of solutions was injected. Photodiode array detector was used to test the peak purity and the chromatograms were extracted at 210 nm. Naphazoline hydrochloride was used as internal standard. The method was validated with respect to specificity, linearity, accuracy, precision, limit of quantitation and limit of detection. The validation acceptance criteria were met in all cases. Identification of the pure peaks was carried out using library match programmer and wavelengths of derivative optima of the spectrograms of the peaks. The method was successfully applied to the determination of the investigated drugs and their degradation products in different batches of granisetron injections. The method was proved to be sensitive for the determination down to 0.03 and 0.01% of granisetron degradation product and benzaldehyde, respectively, which are far below the compendia limits for testing these degradation products in their corresponding intact drugs. Copyright 2010 Elsevier B.V. All rights reserved.

Determination of colonoscopy indication from administrative claims data.

PubMed

Ko, Cynthia W; Dominitz, Jason A; Neradilek, Moni; Polissar, Nayak; Green, Pam; Kreuter, William; Baldwin, Laura-Mae

2014-04-01

Colonoscopy outcomes, such as polyp detection or complication rates, may differ by procedure indication. To develop methods to classify colonoscopy indications from administrative data, facilitating study of colonoscopy quality and outcomes. We linked 14,844 colonoscopy reports from the Clinical Outcomes Research Initiative, a national repository of endoscopic reports, to the corresponding Medicare Carrier and Outpatient File claims. Colonoscopy indication was determined from the procedure reports. We developed algorithms using classification and regression trees and linear discriminant analysis (LDA) to classify colonoscopy indication. Predictor variables included ICD-9CM and CPT/HCPCS codes present on the colonoscopy claim or in the 12 months prior, patient demographics, and site of colonoscopy service. Algorithms were developed on a training set of 7515 procedures, then validated using a test set of 7329 procedures. Sensitivity was lowest for identifying average-risk screening colonoscopies, varying between 55% and 86% for the different algorithms, but specificity for this indication was consistently over 95%. Sensitivity for diagnostic colonoscopy varied between 77% and 89%, with specificity between 55% and 87%. Algorithms with classification and regression trees with 7 variables or LDA with 10 variables had similar overall accuracy, and generally lower accuracy than the algorithm using LDA with 30 variables. Algorithms using Medicare claims data have moderate sensitivity and specificity for colonoscopy indication, and will be useful for studying colonoscopy quality in this population. Further validation may be needed before use in alternative populations.

Heat shock protein 90 functions to stabilize and activate the testis-specific serine/threonine kinases, a family of kinases essential for male fertility.

PubMed

Jha, Kula N; Coleman, Alyssa R; Wong, Lily; Salicioni, Ana M; Howcroft, Elizabeth; Johnson, Gibbes R

2013-06-07

Spermiogenesis is characterized by a profound morphological differentiation of the haploid spermatid into spermatozoa. The testis-specific serine/threonine kinases (TSSKs) comprise a family of post-meiotic kinases expressed in spermatids, are critical to spermiogenesis, and are required for male fertility in mammals. To explore the role of heat shock protein 90 (HSP90) in regulation of TSSKs, the stability and catalytic activity of epitope-tagged murine TSSKs were assessed in 293T and COS-7 cells. TSSK1, -2, -4, and -6 (small serine/threonine kinase) were all found to associate with HSP90, and pharmacological inhibition of HSP90 function using the highly specific drugs 17-AAG, SNX-5422, or NVP-AUY922 reduced TSSK protein levels in cells. The attenuation of HSP90 function abolished the catalytic activities of TSSK4 and -6 but did not significantly alter the specific activities of TSSK1 and -2. Inhibition of HSP90 resulted in increased TSSK ubiquitination and proteasomal degradation, indicating that HSP90 acts to control ubiquitin-mediated catabolism of the TSSKs. To study HSP90 and TSSKs in germ cells, a mouse primary spermatid culture model was developed and characterized. Using specific antibodies against murine TSSK2 and -6, it was demonstrated that HSP90 inhibition resulted in a marked decrease of the endogenous kinases in spermatids. Together, our findings demonstrate that HSP90 plays a broad and critical role in stabilization and activation of the TSSK family of protein kinases.

Performance Indicators: Information in Search of a Valid and Reliable Use.

ERIC Educational Resources Information Center

Carrigan, Sarah D.; Hackett, E. Raymond

1998-01-01

Examined the usefulness of performance indicators in campus decision making at 20 institutions with Carnegie Baccalaureate II classification using hypothesis testing and case-study approaches. Performance measures most commonly cited as measures of financial viability were of limited use for specific policy development, but were most useful within…

Examining the validity of self-reports on scales measuring students' strategic processing.

PubMed

Samuelstuen, Marit S; Bråten, Ivar

2007-06-01

Self-report inventories trying to measure strategic processing at a global level have been much used in both basic and applied research. However, the validity of global strategy scores is open to question because such inventories assess strategy perceptions outside the context of specific task performance. The primary aim was to examine the criterion-related and construct validity of the global strategy data obtained with the Cross-Curricular Competencies (CCC) scale. Additionally, we wanted to compare the validity of these data with the validity of data obtained with a task-specific self-report inventory focusing on the same types of strategies. The sample included 269 10th-grade students from 12 different junior high schools. Global strategy use as assessed with the CCC was compared with task-specific strategy use reported in three different reading situations. Moreover, relationships between scores on the CCC and scores on measures of text comprehension were examined and compared with relationships between scores on the task-specific strategy measure and the same comprehension measures. The comparison between the CCC strategy scores and the task-specific strategy scores suggested only modest criterion-related validity for the data obtained with the global strategy inventory. The CCC strategy scores were also not related to the text comprehension measures, indicating poor construct validity. In contrast, the task-specific strategy scores were positively related to the comprehension measures, indicating good construct validity. Attempts to measure strategic processing at a global level seem to have limited validity and utility.

Selection of biological indicator for validating microwave heating sterilization.

PubMed

Sasaki, K; Mori, Y; Honda, W; Miyake, Y

1998-01-01

For the purpose of selecting an appropriate biological indicator for evaluation of the effects of microwave heating sterilization, we examined aerobic bacterial spores to determine whether microwaves have non-thermal sterilization effects. After microwave irradiation on dry bacterial spores (three species), none of the bacterial spores were killed. The survival rate of the spores after microwave irradiation of spore suspensions (twelve species) was compared with that after heating by a conventional method. The order of heat resistance in the bacterial species was similar between the two heating methods. Bacillus stearothermophilus spores were the most heat-resistant. These results suggest that microwaves have no non-thermal sterilization effects on bacterial spores, the specific resistant spores to microwave heating, and microwave heating sterilization can be evaluated in the same way as for conventional heating sterilization. As a biological indicator for evaluation of overkill sterilization, B. stearothermophilus spores may be appropriate for microwave heating sterilization as well as steam sterilization.

Linguistic validation and reliability properties are weak investigated of most dementia-specific quality of life measurements-a systematic review.

PubMed

Dichter, Martin Nikolaus; Schwab, Christian G G; Meyer, Gabriele; Bartholomeyczik, Sabine; Halek, Margareta

2016-02-01

For people with dementia, the concept of quality of life (Qol) reflects the disease's impact on the whole person. Thus, Qol is an increasingly used outcome measure in dementia research. This systematic review was performed to identify available dementia-specific Qol measurements and to assess the quality of linguistic validations and reliability studies of these measurements (PROSPERO 2013: CRD42014008725). The MEDLINE, CINAHL, EMBASE, PsycINFO, and Cochrane Methodology Register databases were systematically searched without any date restrictions. Forward and backward citation tracking were performed on the basis of selected articles. A total of 70 articles addressing 19 dementia-specific Qol measurements were identified; nine measurements were adapted to nonorigin countries. The quality of the linguistic validations varied from insufficient to good. Internal consistency was the most frequently tested reliability property. Most of the reliability studies lacked internal validity. Qol measurements for dementia are insufficiently linguistic validated and not well tested for reliability. None of the identified measurements can be recommended without further research. The application of international guidelines and quality criteria is strongly recommended for the performance of linguistic validations and reliability studies of dementia-specific Qol measurements. Copyright © 2016 Elsevier Inc. All rights reserved.

Optimization of ultrasound-assisted extraction of pectinase enzyme from guava (Psidium guajava) peel: Enzyme recovery, specific activity, temperature, and storage stability.

PubMed

Amid, Mehrnoush; Murshid, Fara Syazana; Manap, Mohd Yazid; Islam Sarker, Zaidul

2016-01-01

This study aimed to investigate the effects of the ultrasound-assisted extraction conditions on the yield, specific activity, temperature, and storage stability of the pectinase enzyme from guava peel. The ultrasound variables studied were sonication time (10-30 min), ultrasound temperature (30-50 °C), pH (2.0-8.0), and solvent-to-sample ratio (2:1 mL/g to 6:1 mL/g). The main goal was to optimize the ultrasound-assisted extraction conditions to maximize the recovery of pectinase from guava peel with the most desirable enzyme-specific activity and stability. Under the optimum conditions, a high yield (96.2%), good specific activity (18.2 U/mg), temperature stability (88.3%), and storage stability (90.3%) of the extracted enzyme were achieved. The optimal conditions were 20 min sonication time, 40 °C temperature, at pH 5.0, using a 4:1 mL/g solvent-to-sample ratio. The study demonstrated that optimization of ultrasound-assisted process conditions for the enzyme extraction could improve the enzymatic characteristics and yield of the enzyme.

Development and Validation of a Stability-Indicating HPLC Method for Imidapril and Its Degradation Products Using a Design of Experiment (DoE) Approach.

PubMed

Arumugam, Abiramasundari; Joshi, Amita; Vasu, Kamala K

2017-11-01

The present work focused on the application of design of experiment (DoE) principles to the development and optimization of a stability-indicating method (SIM) for the drug imidapril hydrochloride and its degradation products (DPs). The resolution of peaks for the DPs and their drug in a SIM can be influenced by many factors. The factors studied here were pH, gradient time, organic modifier, flow rate, molar concentration of the buffer, and wavelength, with the aid of a Plackett-Burman design. Results from the Plackett-Burman study conspicuously showed influence of two factors, pH and gradient time, on the analyzed response, particularly, the resolution of the closely eluting DPs (DP-5 and DP-6) and the retention time of the last peak. Optimization of the multiresponse processes was achieved through Derringer's desirability function with the assistance of a full factorial design. Separation was achieved using a C18 Phenomenex Luna column (250 × 4.6 mm id, 5 µm particle size) at a flow rate of 0.8 mL/min at 210 nm. The optimized mobile phase composition was ammonium-acetate buffer (pH 5) in pump A and acetonitrile-methanol (in equal ratio) in pump B with a run time of 40 min using a gradient method.

Formal Methods for Verification and Validation of Partial Specifications: A Case Study

NASA Technical Reports Server (NTRS)

Easterbrook, Steve; Callahan, John

1997-01-01

This paper describes our work exploring the suitability of formal specification methods for independent verification and validation (IV&V) of software specifications for large, safety critical systems. An IV&V contractor often has to perform rapid analysis on incomplete specifications, with no control over how those specifications are represented. Lightweight formal methods show significant promise in this context, as they offer a way of uncovering major errors, without the burden of full proofs of correctness. We describe a case study of the use of partial formal models for V&V of the requirements for Fault Detection Isolation and Recovery on the space station. We conclude that the insights gained from formalizing a specification are valuable, and it is the process of formalization, rather than the end product that is important. It was only necessary to build enough of the formal model to test the properties in which we were interested. Maintenance of fidelity between multiple representations of the same requirements (as they evolve) is still a problem, and deserves further study.

Validation of an Immunodiagnostic Assay for Detection of 13 Streptococcus pneumoniae Serotype-Specific Polysaccharides in Human Urine

PubMed Central

Huijts, Susanne M.; Wu, Kangjian; Souza, Victor; Passador, Sherry; Tinder, Chunyan; Song, Esther; Elfassy, Arik; McNeil, Lisa; Menton, Ronald; French, Roger; Callahan, Janice; Webber, Chris; Gruber, William C.; Bonten, Marc J. M.; Jansen, Kathrin U.

2012-01-01

To improve the clinical diagnosis of pneumococcal infection in bacteremic and nonbacteremic community-acquired pneumonia (CAP), a Luminex technology-based multiplex urinary antigen detection (UAD) diagnostic assay was developed and validated. The UAD assay can simultaneously detect 13 different serotypes of Streptococcus pneumoniae by capturing serotype-specific S. pneumoniae polysaccharides (PnPSs) secreted in human urine. Assay specificity is achieved by capturing the polysaccharides with serotype-specific monoclonal antibodies (MAbs) on spectrally unique microspheres. Positivity for each serotype was based on positivity cutoff values calculated from a standard curve run on each assay plate together with positive- and negative-control urine samples. The assay is highly specific, since significant signals are detected only when each PnPS was paired with its homologous MAb-coated microspheres. Validation experiments demonstrated excellent accuracy and precision. The UAD assay and corresponding positivity cutoff values were clinically validated by assessing 776 urine specimens obtained from patients with X-ray-confirmed CAP. The UAD assay demonstrated 97% sensitivity and 100% specificity using samples obtained from patients with bacteremic, blood culture-positive CAP. Importantly, the UAD assay identified Streptococcus pneumoniae (13 serotypes) in a proportion of individuals with nonbacteremic CAP, a patient population for which the pneumococcal etiology of CAP was previously difficult to assess. Therefore, the UAD assay provides a specific, noninvasive, sensitive, and reproducible tool to support vaccine efficacy as well as epidemiological evaluation of pneumococcal disease, including CAP, in adults. PMID:22675155

Validation of an immunodiagnostic assay for detection of 13 Streptococcus pneumoniae serotype-specific polysaccharides in human urine.

PubMed

Pride, Michael W; Huijts, Susanne M; Wu, Kangjian; Souza, Victor; Passador, Sherry; Tinder, Chunyan; Song, Esther; Elfassy, Arik; McNeil, Lisa; Menton, Ronald; French, Roger; Callahan, Janice; Webber, Chris; Gruber, William C; Bonten, Marc J M; Jansen, Kathrin U

2012-08-01

To improve the clinical diagnosis of pneumococcal infection in bacteremic and nonbacteremic community-acquired pneumonia (CAP), a Luminex technology-based multiplex urinary antigen detection (UAD) diagnostic assay was developed and validated. The UAD assay can simultaneously detect 13 different serotypes of Streptococcus pneumoniae by capturing serotype-specific S. pneumoniae polysaccharides (PnPSs) secreted in human urine. Assay specificity is achieved by capturing the polysaccharides with serotype-specific monoclonal antibodies (MAbs) on spectrally unique microspheres. Positivity for each serotype was based on positivity cutoff values calculated from a standard curve run on each assay plate together with positive- and negative-control urine samples. The assay is highly specific, since significant signals are detected only when each PnPS was paired with its homologous MAb-coated microspheres. Validation experiments demonstrated excellent accuracy and precision. The UAD assay and corresponding positivity cutoff values were clinically validated by assessing 776 urine specimens obtained from patients with X-ray-confirmed CAP. The UAD assay demonstrated 97% sensitivity and 100% specificity using samples obtained from patients with bacteremic, blood culture-positive CAP. Importantly, the UAD assay identified Streptococcus pneumoniae (13 serotypes) in a proportion of individuals with nonbacteremic CAP, a patient population for which the pneumococcal etiology of CAP was previously difficult to assess. Therefore, the UAD assay provides a specific, noninvasive, sensitive, and reproducible tool to support vaccine efficacy as well as epidemiological evaluation of pneumococcal disease, including CAP, in adults.

The Resilience Questionnaire for Bipolar Disorder: Development and validation.

PubMed

Echezarraga, Ainara; Las Hayas, Carlota; González-Pinto, Ana María; Jones, Steven

2017-08-01

The goal of this research project was to develop a new questionnaire to assess resilience in Bipolar Disorder (BD), the Resilience Questionnaire for Bipolar Disorder (RBD). To examine its psychometric properties, a sample of 125 patients diagnosed with BD and a comparison sample of 107 people completed the new RBD and established measures of generic resilience and health-related outcomes. Exploratory factor analysis for the RBD yielded a 23-item 5-factor solution, and confirmatory factor analysis indicated adequate fit indices. Internal consistency, stability, concurrent validation and known-groups' validity were also supported. The RBD obtained higher responsiveness (6-month follow-up) than the generic resilience scale (BD sample). The RBD is a robust measure to monitor resilience in BD. Copyright © 2017 Elsevier Inc. All rights reserved.

An experimentally validated network of nine haematopoietic transcription factors reveals mechanisms of cell state stability

PubMed Central

Schütte, Judith; Wang, Huange; Antoniou, Stella; Jarratt, Andrew; Wilson, Nicola K; Riepsaame, Joey; Calero-Nieto, Fernando J; Moignard, Victoria; Basilico, Silvia; Kinston, Sarah J; Hannah, Rebecca L; Chan, Mun Chiang; Nürnberg, Sylvia T; Ouwehand, Willem H; Bonzanni, Nicola; de Bruijn, Marella FTR; Göttgens, Berthold

2016-01-01

Transcription factor (TF) networks determine cell-type identity by establishing and maintaining lineage-specific expression profiles, yet reconstruction of mammalian regulatory network models has been hampered by a lack of comprehensive functional validation of regulatory interactions. Here, we report comprehensive ChIP-Seq, transgenic and reporter gene experimental data that have allowed us to construct an experimentally validated regulatory network model for haematopoietic stem/progenitor cells (HSPCs). Model simulation coupled with subsequent experimental validation using single cell expression profiling revealed potential mechanisms for cell state stabilisation, and also how a leukaemogenic TF fusion protein perturbs key HSPC regulators. The approach presented here should help to improve our understanding of both normal physiological and disease processes. DOI: http://dx.doi.org/10.7554/eLife.11469.001 PMID:26901438

Influence of sodium metabisulfite and glutathione on the stability of vitamin C in O/W emulsion and extemporaneous aqueous gel.

PubMed

Maia, Adriana M; Baby, André Rolim; Pinto, Claudinéia A S O; Yasaka, Wilson J; Suenaga, Eunice; Kaneko, Telma M; Velasco, Maria Valéria Robles

2006-09-28

Vitamin C exerts several functions on skin as collagen synthesis, depigmentant and antioxidant activity. Vitamin C is unstable in the presence of oxygen, luminosity, humidity, high temperatures and heavy metals, which presents a significant challenge to the development of cosmetic formulations. Therefore, the utilization of an effective antioxidant system is required to maintain the vitamin C stability. The purpose of this research work was to develop prototypes of cosmetic formulations, as O/W emulsion and extemporaneous aqueous gel, containing vitamin C and to evaluate the influence of sodium metabisulfite (SMB) and glutathione (GLT), as antioxidants, on the stability of the active substance. A HPLC stability-indicating method was developed and validated for this study and stability assays were performed in 90 and 26 days and storage conditions were 5.0+/-0.5, 24+/-2 and 40.0+/-0.5 degrees C. The HPLC stability-indicating method showed linearity (r(2)>0.99), specificity, R.S.D.<1.22% and accuracy/recovery ranging from 95.46 to 101.54%. Preparations with SMB or GLT and the antioxidant-free presented results statistically distinct, demonstrating the necessity of the antioxidant system addition. O/W emulsions with SMB or GLT retained the vitamin C content >90.38% stored at 5.0+/-0.5 and 24+/-2 degrees C. For the aqueous gel with SMB or GLT, the active substance concentration was maintained >94.03%. Considering the vitamin C stability, the SMB and the GLT showed to be statistically adequate, as antioxidants, for the cosmetic formulations.

Reliability and validity of the Tilburg Frailty Indicator (TFI) among Chinese community-dwelling older people.

PubMed

Dong, Lijuan; Liu, Na; Tian, Xiaoyu; Qiao, Xiaoxia; Gobbens, Robbert J J; Kane, Robert L; Wang, Cuili

2017-11-01

To translate the Tilburg Frailty Indicator (TFI) into Chinese and assess its reliability and validity. A sample of 917 community-dwelling older people, aged ≥60 years, in a Chinese city was included between August 2015 and March 2016. Construct validity was assessed using alternative measures corresponding to the TFI items, including self-rated health status (SRH), unintentional weight loss, walking speed, timed-up-and-go tests (TUGT), making telephone calls, grip strength, exhaustion, Short Portable Mental Status Questionnaire (SPMSQ), Geriatric Depression scale (GDS-15), emotional role, Adaptability Partnership Growth Affection and Resolve scale (APGAR) and Social Support Rating Scale (SSRS). Fried's phenotype and frailty index were measured to evaluate criterion validity. Adverse health outcomes (ADL and IADL disability, healthcare utilization, GDS-15, SSRS) were used to assess predictive (concurrent) validity. The internal consistency reliability was good (Cronbach's α=0.71). The test-retest reliability was strong (r=0.88). Kappa coefficients showed agreements between the TFI items and corresponding alternative measures. Alternative measures correlated as expected with the three domains of TFI, with an exclusion that alternative psychological measures had similar correlations with psychological and physical domains of the TFI. The Chinese TFI had excellent criterion validity with the AUCs regarding physical phenotype and frailty index of 0.87 and 0.86, respectively. The predictive (concurrent) validities of the adverse health outcomes and healthcare utilization were acceptable (AUCs: 0.65-0.83). The Chinese TFI has good validity and reliability as an integral instrument to measure frailty of older people living in the community in China. Copyright © 2017 Elsevier B.V. All rights reserved.

Development of a golf-specific load monitoring tool: Content validity and feasibility.

PubMed

Williams, Scott B; Gastin, Paul B; Saw, Anna E; Robertson, Sam

2018-05-01

Athletes often record details of their training and competitions, supported by information such as environmental conditions, travel, as well as how they felt. However, it is not known how prevalent these practices are in golfers, or how valuable this process is perceived. The purpose of this study was to develop a golf-specific load monitoring tool (GLMT), and establish the content validity and feasibility of this tool amongst high-level golfers. In the first phase of development, 21 experts were surveyed to determine the suitability of items for inclusion in the GLMT. Of the 36 items, 21 received >78% agreement, a requirement to establish content validity and for inclusion in the GLMT. Total duration was the preferred metric for golf-specific activities, whilst rating of perceived exertion (RPE) was preferred for measuring physical training. In the second phase, feasibility of the tool was assessed by surveying 13 high-level male golfers following 28-days of daily GLMT use. All items included in the GLMT were deemed feasible to record, with all players participating in the feasibility study providing high to very high ratings. Golfers responded that they would consider using a load monitoring tool of this nature long term, provided it can be completed in less than five minutes per day.

Application of quality by design concept to develop a dual gradient elution stability-indicating method for cloxacillin forced degradation studies using combined mixture-process variable models.

PubMed

Zhang, Xia; Hu, Changqin

2017-09-08

Penicillins are typical of complex ionic samples which likely contain large number of degradation-related impurities (DRIs) with different polarities and charge properties. It is often a challenge to develop selective and robust high performance liquid chromatography (HPLC) methods for the efficient separation of all DRIs. In this study, an analytical quality by design (AQbD) approach was proposed for stability-indicating method development of cloxacillin. The structures, retention and UV characteristics rules of penicillins and their impurities were summarized and served as useful prior knowledge. Through quality risk assessment and screen design, 3 critical process parameters (CPPs) were defined, including 2 mixture variables (MVs) and 1 process variable (PV). A combined mixture-process variable (MPV) design was conducted to evaluate the 3 CPPs simultaneously and a response surface methodology (RSM) was used to achieve the optimal experiment parameters. A dual gradient elution was performed to change buffer pH, mobile-phase type and strength simultaneously. The design spaces (DSs) was evaluated using Monte Carlo simulation to give their possibility of meeting the specifications of CQAs. A Plackett-Burman design was performed to test the robustness around the working points and to decide the normal operating ranges (NORs). Finally, validation was performed following International Conference on Harmonisation (ICH) guidelines. To our knowledge, this is the first study of using MPV design and dual gradient elution to develop HPLC methods and improve separations for complex ionic samples. Copyright © 2017 Elsevier B.V. All rights reserved.

Stability-Indicating Liquid Chromatographic Methods with Photodiode Array Detection and Light Scattering Detection for Simultaneous Determination of Candesartan and Hydrochlorothiazide.

PubMed

de Diego, Marta; Godoy, Ricardo; Mennickent, Sigrid; Vergara, Carola; Miranda, Daniel; Navarro, Pía

2018-02-01

Development, validation and comparison of two stability-indicating LC methods, one with photodiode array detector (DAD) and the other with evaporative light scattering detector (ELSD), were performed for simultaneous determination of candesartan cilexetil (CANC) and hydrochlorothiazide (HCTZ), in pharmaceutical samples. A RP-18 column (125 mm × 4 mm, 5 μm) was used for separation of CANC, HCTZ and its major degradation products, using acetonitrile and phosphate buffer (pH 6.0) for DAD method and acetonitrile and water with acetic acid and triethylamine (pH 4.1) for ELSD method, as mobile phase in a gradient mode. The response with ELSD was fitted to a power function and the DAD response by a linear model over a range of 32-160 μg/mL for CANC and 25-125 μg/mL for HCTZ. The precision and accuracy of the methods were similar, with RSD below 3.0% and recovery between 98.1% and 103.9%. The drugs were subjected to stress conditions of hydrolysis, oxidation, photolysis, humidity and temperature. The degradation products were satisfactory separated from the main peaks and from each other. Both drugs mainly degrade by hydrolysis, showing the formation of one degradation product for HCTZ and two for CANC; its identification was conducted by LC/MS/MS. The methods were successfully applied to the analysis of CANC and HCTZ in combined commercial tablets. The performance of DAD and ELSD methods are comparable, therefore both methods are suitable for stability study and determination of CANC and HCTZ in pharmaceutical samples. © The Author 2017. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Validation of a Cross-cultural Adaptation of the Hair Specific Skindex-29 Scale to Spanish.

PubMed

Guerra-Tapia, A; Buendía-Eisman, A; Ferrando, J

2018-06-01

Female androgenetic alopecia (FAA) has considerable impact on quality of life. Our analysis of the clinical scales available in the literature to measure the impact of FAA led us to choose the Hair Specific Skindex 29 (HSS29) as the most appropriate for adaptation to Spanish as a tool for following patients in treatment for FAA. This tool assesses disease impact on quality of life over time so that treatments can be tailored to patients' needs. The HSS29 score reflects impact in 3 domains (emotions, symptoms, and functioning) on a scale of 0 (no effect) to 100 (maximum effect). The scale is useful in routine clinical practice, and patients can respond to all items in 5minutes. We followed recommended procedures to produce a cross-cultural adaptation of the scale. The process involved forward translation of the questionnaire to Spanish followed by back translation by 2 native speakers of the original language (English) and revision as needed after discussion and consensus by a committee of 3 expert dermatologists. The comprehensibility of the resulting translation was assessed in a test-retest step. Next, the psychometric properties, reliability, and construct validity were assessed. Sensitivity and specificity were evaluated with the area under the receiver operating characteristic (ROC) curve, reliability with Cronbach's α, and construct validity by factor analysis using a Varimax rotation. Face validity was also assessed during the process. The intraclass correlation coefficient (ICC) was calculated in the test-retest step. A total of 170 women with FAA and 30 control subjects completed the cross-culturally adapted Spanish questionnaire. A subgroup of 15 subjects responded a second time between 1 and 2 days after their first session (test-retest). Sensitivity and specificity were excellent according to the area under the ROC curve (0.98; 95% CI, 0.97-0.99), and high reliability was reflected by a Cronbach's α of 0.96. Factor analysis showed that the items were

Commissioning and validation of COMPASS system for VMAT patient specific quality assurance

NASA Astrophysics Data System (ADS)

Pimthong, J.; Kakanaporn, C.; Tuntipumiamorn, L.; Laojunun, P.; Iampongpaiboon, P.

2016-03-01

Pre-treatment patient specific quality assurance (QA) of advanced treatment techniques such as volumetric modulated arc therapy (VMAT) is one of important QA in radiotherapy. The fast and reliable dosimetric device is required. The objective of this study is to commission and validate the performance of COMPASS system for dose verification of VMAT technique. The COMPASS system is composed of an array of ionization detectors (MatriXX) mounted to the gantry using a custom holder and software for the analysis and visualization of QA results. We validated the COMPASS software for basic and advanced clinical application. For the basic clinical study, the simple open field in various field sizes were validated in homogeneous phantom. And the advanced clinical application, the fifteen prostate and fifteen nasopharyngeal cancers VMAT plans were chosen to study. The treatment plans were measured by the MatriXX. The doses and dose-volume histograms (DVHs) reconstructed from the fluence measurements were compared to the TPS calculated plans. And also, the doses and DVHs computed using collapsed cone convolution (CCC) Algorithm were compared with Eclipse TPS calculated plans using Analytical Anisotropic Algorithm (AAA) that according to dose specified in ICRU 83 for PTV.

Construct validity of the Groningen Frailty Indicator established in a large sample of home-dwelling elderly persons: Evidence of stability across age and gender.

PubMed

Peters, L L; Boter, H; Burgerhof, J G M; Slaets, J P J; Buskens, E

2015-09-01

The primary objective of the present study was to evaluate the validity of the Groningen Frailty Indicator (GFI) in a sample of Dutch elderly persons participating in LifeLines, a large population-based cohort study. Additional aims were to assess differences between frail and non-frail elderly and examine which individual characteristics were associated with frailty. By December 2012, 5712 elderly persons were enrolled in LifeLines and complied with the inclusion criteria of the present study. Mann-Whitney U or Kruskal-Wallis tests were used to assess the variability of GFI-scores among elderly subgroups that differed in demographic characteristics, morbidity, obesity, and healthcare utilization. Within subgroups Kruskal-Wallis tests were also used to examine differences in GFI-scores across age groups. Multivariate logistic regression analyses were performed to assess associations between individual characteristics and frailty. The GFI discriminated between subgroups: statistically significantly higher GFI-median scores (interquartile range) were found in e.g. males (1 [0-2]), the oldest old (2 [1-3]), in elderly who were single (1 [0-2]), with lower socio economic status (1 [0-3]), with increasing co-morbidity (2 [1-3]), who were obese (2 [1-3]), and used more healthcare (2 [1-4]). Overall age had an independent and statistically significant association with GFI scores. Compared with the non-frail, frail elderly persons experienced statistically significantly more chronic stress and more social/psychological related problems. In the multivariate logistic regression model, psychological morbidity had the strongest association with frailty. The present study supports the construct validity of the GFI and provides an insight in the characteristics of (non)frail community-dwelling elderly persons participating in LifeLines. Copyright © 2015 Elsevier Inc. All rights reserved.

Stabilization of protein-protein interactions in drug discovery.

PubMed

Andrei, Sebastian A; Sijbesma, Eline; Hann, Michael; Davis, Jeremy; O'Mahony, Gavin; Perry, Matthew W D; Karawajczyk, Anna; Eickhoff, Jan; Brunsveld, Luc; Doveston, Richard G; Milroy, Lech-Gustav; Ottmann, Christian

2017-09-01

PPIs are involved in every disease and specific modulation of these PPIs with small molecules would significantly improve our prospects of developing therapeutic agents. Both industry and academia have engaged in the identification and use of PPI inhibitors. However in comparison, the opposite strategy of employing small-molecule stabilizers of PPIs is underrepresented in drug discovery. Areas covered: PPI stabilization has not been exploited in a systematic manner. Rather, this concept validated by a number of therapeutically used natural products like rapamycin and paclitaxel has been shown retrospectively to be the basis of the activity of synthetic molecules originating from drug discovery projects among them lenalidomide and tafamidis. Here, the authors cover the growing number of synthetic small-molecule PPI stabilizers to advocate for a stronger consideration of this as a drug discovery approach. Expert opinion: Both the natural products and the growing number of synthetic molecules show that PPI stabilization is a viable strategy for drug discovery. There is certainly a significant challenge to adapt compound libraries, screening techniques and downstream methodologies to identify, characterize and optimize PPI stabilizers, but the examples of molecules reviewed here in our opinion justify these efforts.

Recommendations for the evaluation of specimen stability for flow cytometric testing during drug development.

PubMed

Brown, Lynette; Green, Cherie L; Jones, Nicholas; Stewart, Jennifer J; Fraser, Stephanie; Howell, Kathy; Xu, Yuanxin; Hill, Carla G; Wiwi, Christopher A; White, Wendy I; O'Brien, Peter J; Litwin, Virginia

2015-03-01

The objective of this manuscript is to present an approach for evaluating specimen stability for flow cytometric methods used during drug development. While this approach specifically addresses stability assessment for assays to be used in clinical trials with centralized testing facilities, the concepts can be applied to any stability assessment for flow cytometric methods. The proposed approach is implemented during assay development and optimization, and includes suggestions for designing a stability assessment plan, data evaluation and acceptance criteria. Given that no single solution will be applicable in all scenarios, this manuscript offers the reader a roadmap for stability assessment and is intended to guide the investigator during both the method development phase and in the experimental design of the validation plan. Copyright © 2015 Elsevier B.V. All rights reserved.

Validation of a field test for the non-invasive determination of badminton specific aerobic performance

PubMed Central

Wonisch, M; Hofmann, P; Schwaberger, G; von Duvillard, S P; Klein, W

2003-01-01

Aim: To develop a badminton specific test to determine on court aerobic and anaerobic performance. Method: The test was evaluated by using a lactate steady state test. Seventeen male competitive badminton players (mean (SD) age 26 (8) years, weight 74 (10) kg, height 179 (7) cm) performed an incremental field test on the badminton court to assess the heart rate turn point (HRTP) and the individual physical working capacity (PWCi) at 90% of measured maximal heart rate (HRmax). All subjects performed a 20 minute steady state test at a workload just below the PWCi. Results: Significant correlations (p<0.05) for Pearson's product moment coefficient were found between the two methods for HR (r = 0.78) and velocity (r = 0.93). The HR at the PWCi (176 (5.5) beats/min) was significantly lower than the HRTP (179 (5.5) beats/min), but no significant difference was found for velocity (1.44 (0.3) m/s, 1.38 (0.4) m/s). The constant exercise test showed steady state conditions for both HR (175 (9) beats/min) and blood lactate concentration (3.1 (1.2) mmol/l). Conclusion: The data indicate that a valid determination of specific aerobic and anaerobic exercise performance for the sport of badminton is possible without HRTP determination. PMID:12663351

Single-Shot Scalar-Triplet Measurements in High-Pressure Swirl-Stabilized Flames for Combustion Code Validation

NASA Technical Reports Server (NTRS)

Kojima, Jun; Nguyen, Quang-Viet

2007-01-01

In support of NASA ARMD's code validation project, we have made significant progress by providing the first quantitative single-shot multi-scalar data from a turbulent elevated-pressure (5 atm), swirl-stabilized, lean direct injection (LDI) type research burner operating on CH4-air using a spatially-resolved pulsed-laser spontaneous Raman diagnostic technique. The Raman diagnostics apparatus and data analysis that we present here were developed over the past 6 years at Glenn Research Center. From the Raman scattering data, we produce spatially-mapped probability density functions (PDFs) of the instantaneous temperature, determined using a newly developed low-resolution effective rotational bandwidth (ERB) technique. The measured 3-scalar (triplet) correlations, between temperature, CH4, and O2 concentrations, as well as their PDF s, also provide a high-level of detail into the nature and extent of the turbulent mixing process and its impact on chemical reactions in a realistic gas turbine injector flame at elevated pressures. The multi-scalar triplet data set presented here provides a good validation case for CFD combustion codes to simulate by providing both average and statistical values for the 3 measured scalars.

Systematic review of systemic sclerosis-specific instruments for the EULAR Outcome Measures Library: An evolutional database model of validated patient-reported outcomes.

PubMed

Ingegnoli, Francesca; Carmona, Loreto; Castrejon, Isabel

2017-04-01

The EULAR Outcome Measures Library (OML) is a freely available database of validated patient-reported outcomes (PROs). The aim of this study was to provide a comprehensive review of validated PROs specifically developed for systemic sclerosis (SSc) to feed the EULAR OML. A sensitive search was developed in Medline and Embase to identify all validation studies, cohort studies, reviews, or meta-analyses in which the objective were the development or validation of specific PROs evaluating organ involvement, disease activity or damage in SSc. A reviewer screened title and abstracts, selected the studies, and collected data concerning validation using ad hoc forms based on the COSMIN checklist. From 13,140 articles captured, 74 met the predefined criteria. After excluding two instruments as they were unavailable in English the selected 23 studies provided information on seven SSc-specific PROs on different SSc domains: burden of illness (symptom burden index), functional status (Scleroderma Assessment Questionnaire), functional ability (scleroderma Functional Score), Raynaud's phenomenon (Raynaud's condition score), mouth involvement (Mouth Handicap in SSc), gastro-intestinal involvement (University of California Los Angeles-Scleroderma Clinical Trial Consortium Gastro-Intestinal tract 2.0), and skin involvement (skin self-assessment). Each of them is partially validated and has different psychometric requirements. Seven SSc-specific PROs have a minimum validation and were included in the EULAR OML. Further development in the area of disease-specific PROs in SSc is warranted. Copyright © 2017 Elsevier Inc. All rights reserved.

Development and Validation of a Disease-Specific Instrument to Measure Diet-Targeted Quality of Life for Postoperative Patients with Esophagogastric Cancer.

PubMed

Honda, Michitaka; Wakita, Takafumi; Onishi, Yoshihiro; Nunobe, Souya; Miura, Akinori; Nishigori, Tatsuto; Kusanagi, Hiroshi; Yamamoto, Takatsugu; Boddy, Alexander; Fukuhara, Shunichi

2015-12-01

Patients who have undergone esophagectomy or gastrectomy have certain dietary limitations because of changes to the alimentary tract. This study attempted to develop a psychometric scale, named "Esophago-Gastric surgery and Quality of Dietary life (EGQ-D)," for assessment of impact of upper gastrointestinal surgery on diet-targeted quality of life. Using qualitative methods, the study team interviewed both patients and surgeons involved in esophagogastric cancer surgery, and we prepared an item pool and a draft scale. To evaluate the scale's psychometric reliability and validity, a survey involving a large number of patients was conducted. Items for the final scale were selected by factor analysis and item response theory. Cronbach's alpha was used for assessment of reliability, and correlations with the short form (SF)-12, esophagus and stomach surgery symptom scale (ES(4)), and nutritional indicators were analyzed to assess the criterion-related validity. Through multifaceted discussion and the pilot study, a draft questionnaire comprising 14 items was prepared, and a total of 316 patients were enrolled. On the basis of factor analysis and item response theory, six items were excluded, and the remaining eight items demonstrated strong unidimensionality for the final scale. Cronbach's alpha was 0.895. There were significant associations with all the subscale scores for SF-12, ES(4), and nutritional indicators. The EGQ-D scale has good contents and psychometric validity and can be used to evaluate disease-specific instrument to measure diet-targeted quality of life for postoperative patients with esophagogastric cancer.

Development and validation of the Cancer Exercise Stereotypes Scale.

PubMed

Falzon, Charlène; Sabiston, Catherine; Bergamaschi, Alessandro; Corrion, Karine; Chalabaev, Aïna; D'Arripe-Longueville, Fabienne

2014-01-01

The objective of this study was to develop and validate a French-language questionnaire measuring stereotypes related to exercise in cancer patients: The Cancer Exercise Stereotypes Scale (CESS). Four successive steps were carried out with 806 participants. First, a preliminary version was developed on the basis of the relevant literature and qualitative interviews. A test of clarity then led to the reformulation of six of the 30 items. Second, based on the modification indices of the first confirmatory factorial analysis, 11 of the 30 initial items were deleted. A new factorial structure analysis showed a good fit and validated a 19-item instrument with five subscales. Third, the stability of the instrument was tested over time. Last, tests of construct validity were conducted to examine convergent validity and discriminant validity. The French-language CESS appears to have good psychometric qualities and can be used to test theoretical tenets and inform intervention strategies on ways to foster exercise in cancer patients.

Early Identification of Children at Risk for Academic Difficulties Using Standardized Assessment: Stability and Predictive Validity of Preschool Math and Language Scores

ERIC Educational Resources Information Center

Frans, Niek; Post, Wendy J.; Huisman, Mark; Oenema-Mostert, Ineke C. E.; Keegstra, Anne L.; Minnaert, Alexander E. M. G.

2017-01-01

Despite the claim by several researchers that variability in performance may complicate the identification of "at-risk" children, variability in the academic performance of young children remains an undervalued area of research. The goal of this study is to examine the predictive validity for future scores and the score stability of two…

Measuring personality functioning in older adults: construct validity of the Severity Indices of Personality Functioning - Short Form (SIPP-SF).

PubMed

Rossi, Gina; Debast, Inge; van Alphen, S P J

2017-07-01

The dimensional personality disorders model in the Diagnostic and Statistical Manual (DSM)-5 section III conceptually differentiates impaired personality functioning (criterion A) from the presence of pathological traits (criterion B). This study is the first to specifically address the measurement of criterion A in older adults. Moreover, the convergent/divergent validity of criterion A and criterion B will be compared in younger and older age groups. The Severity Indices of Personality Functioning - Short Form (SIPP-SF) was administered in older (N = 171) and younger adults (N = 210). The factorial structure was analyzed with exploratory structural equation modeling. Differences in convergent/divergent validity between personality functioning (SIPP-SF) and pathological traits (Personality Inventory for DSM-5; Dimensional Assessment of Personality Pathology-Basic Questionnaire) were examined across age groups. Identity Integration, Relational Capacities, Responsibility, Self-Control, and Social Concordance were corroborated as higher order domains. Although the SIPP-SF domains measured unique variation, some high correlations with pathological traits referred to overlapping constructs. Moreover, in older adults, personality functioning was more strongly related to Psychoticism, Disinhibition, Antagonism and Dissocial Behavior compared to younger adults. The SIPP-SF construct validity was demonstrated in terms of a structure of five higher order domains of personality functioning. The instrument is promising as a possible measure of impaired personality functioning in older adults. As such, it is a useful clinical tool to follow up effects of therapy on levels of personality functioning. Moreover, traits were associated with different degrees of personality functioning across age groups.

Validation of the Brazilian version of the Burn Specific Health Scale-Brief (BSHS-B-Br).

PubMed

Piccolo, Monica Sarto; Gragnani, Alfredo; Daher, Ricardo Piccolo; Scanavino, Marco de Tubino; de Brito, Maria José; Ferreira, Lydia Masako

2015-11-01

Progressive increases in survival rates from burn trauma have shifted attention to patient rehabilitation and posttraumatic quality of life. The assessment of quality of life is strongly dependent on reliable instruments for its measurement. A literature review has revealed that the Burn Specific Health Scale-Brief (BSHS-B) questionnaire is the most commonly used instrument worldwide. The aim of this study was to translate the BSHS-B into the Portuguese language, adapt it culturally to the Brazilian population, and test its psychometric properties. The questionnaire was translated into Portuguese; culturally adapted; and tested for reproducibility, face validity, content validity, and construct validity. The translated version was tested on 92 patients with burns. Internal consistency was tested by means of Cronbach's alpha. Construct validity was performed by correlating the BSHS-B questionnaire with the Burn Specific Health Scale-Revised (BSHS-R), BurnSexQ-Escola Paulista de Medicina (EPM)/Universidade Federal De São Paulo (UNIFESP), the Rosenberg Self-Esteem Scale (RSES), and the Beck Depression Inventory (BDI). Cronbach's alpha was 0.85. The Pearson correlation coefficients were significant at three time points of the reliability analysis. A significant correlation was observed between BSHS-B domains and BSHS-R, and between RSES and BDI domains. A significant correlation was also observed between BSHS-B and the BurnSexQ-EPM/UNIFESP social comfort and body image domains. The BSHS-B questionnaire was translated into Portuguese. It is a reliable tool in this language, showing face, content, and construct validity. The modified instrument has been named BSHS-B-Br. Copyright © 2015 Elsevier Ltd and ISBI. All rights reserved.

Utilizing the social media data to validate 'climate change' indices

NASA Astrophysics Data System (ADS)

Molodtsova, T.; Kirilenko, A.; Stepchenkova, S.

2013-12-01

Reporting the observed and modeled changes in climate to public requires the measures understandable by the general audience. E.g., the NASA GISS Common Sense Climate Index (Hansen et al., 1998) reports the change in climate based on six practically observable parameters such as the air temperature exceeding the norm by one standard deviation. The utility of the constructed indices for reporting climate change depends, however, on an assumption that the selected parameters are felt and connected with the changing climate by a non-expert, which needs to be validated. Dynamic discussion of climate change issues in social media may provide data for this validation. We connected the intensity of public discussion of climate change in social networks with regional weather variations for the territory of the USA. We collected the entire 2012 population of Twitter microblogging activity on climate change topic, accumulating over 1.8 million separate records (tweets) globally. We identified the geographic location of the tweets and associated the daily and weekly intensity of twitting with the following parameters of weather for these locations: temperature anomalies, 'hot' temperature anomalies, 'cold' temperature anomalies, heavy rain/snow events. To account for non-weather related events we included the articles on climate change from the 'prestige press', a collection of major newspapers. We found that the regional changes in parameters of weather significantly affect the number of tweets published on climate change. This effect, however, is short-lived and varies throughout the country. We found that in different locations different weather parameters had the most significant effect on climate change microblogging activity. Overall 'hot' temperature anomalies had significant influence on climate change twitting intensity.

Is the Veterans Specific Activity Questionnaire Valid to Assess Older Adults Aerobic Fitness?

PubMed

de Carvalho Bastone, Alessandra; de Souza Moreira, Bruno; Teixeira, Claudine Patrícia; Dias, João Marcos Domingues; Dias, Rosângela Corrêa

2016-01-01

Aerobic fitness in older adults is related to health status, incident disability, nursing home admission, and all-cause mortality. The most accurate quantification of aerobic fitness, expressed as peak oxygen consumption in mL·kg·min, is the cardiorespiratory exercise test; however, it is not feasible in all settings and might offer risk to patients. The Veterans Specific Activity Questionnaire (VSAQ) is a 13-item self-administered symptom questionnaire that estimates aerobic fitness expressed in metabolic equivalents (METs) and has been validated to cardiovascular patients. The purpose of this study was to assess the validity and reliability of the VSAQ in older adults without specific health conditions. A methodological study with a cross-sectional design was conducted with 28 older adults (66-86 years). The VSAQ was administered on 3 occasions by 2 evaluators. Aerobic capacity in METs as measured by the VSAQ was compared with the METs found in an incremental shuttle walk test (ISWT) performed with a portable metabolic measurement system and with accelerometer data. The validity of the VSAQ was found to be moderate-to-good when compared with the METs and distance measured by the ISWT and with the moderate activity per day and steps per day obtained by accelerometry. The Bland-Altman graph analysis showed no values outside the limits of agreement, suggesting good precision between the METs estimated by questionnaire and the METs measured by the ISWT. Also, the intrarater and interrater reliabilities of the instrument were good. The results showed that the VSAQ is a valuable tool to assess the aerobic fitness of older adults.

Validation of the PedsQL Epilepsy Module: A pediatric epilepsy-specific health-related quality of life measure.

PubMed

Modi, Avani C; Junger, Katherine F; Mara, Constance A; Kellermann, Tanja; Barrett, Lauren; Wagner, Janelle; Mucci, Grace A; Bailey, Laurie; Almane, Dace; Guilfoyle, Shanna M; Urso, Lauryn; Hater, Brooke; Hustzi, Heather; Smith, Gigi; Herrmann, Bruce; Perry, M Scott; Zupanc, Mary; Varni, James W

2017-11-01

To validate a brief and reliable epilepsy-specific, health-related quality of life (HRQOL) measure in children with various seizure types, treatments, and demographic characteristics. This national validation study was conducted across five epilepsy centers in the United States. Youth 5-18 years and caregivers of youth 2-18 years diagnosed with epilepsy completed the PedsQL Epilepsy Module and additional questionnaires to establish reliability and validity of the epilepsy-specific HRQOL instrument. Demographic and medical data were collected through chart reviews. Factor analysis was conducted, and internal consistency (Cronbach's alphas), test-retest reliability, and construct validity were assessed. Questionnaires were analyzed from 430 children with epilepsy (M age = 9.9 years; range 2-18 years; 46% female; 62% white: non-Hispanic; 76% monotherapy, 54% active seizures) and their caregivers. The final PedsQL Epilepsy Module is a 29-item measure with five subscales (i.e., Impact, Cognitive, Sleep, Executive Functioning, and Mood/Behavior) with parallel child and caregiver reports. Internal consistency coefficients ranged from 0.70-0.94. Construct validity and convergence was demonstrated in several ways, including strong relationships with seizure outcomes, antiepileptic drug (AED) side effects, and well-established measures of executive, cognitive, and emotional/behavioral functioning. The PedsQL Epilepsy Module is a reliable measure of HRQOL with strong evidence of its validity across the epilepsy spectrum in both clinical and research settings. Wiley Periodicals, Inc. © 2017 International League Against Epilepsy.

A New Symptom Model for Autism Cross-Validated in an Independent Sample

ERIC Educational Resources Information Center

Boomsma, A.; Van Lang, N. D. J.; De Jonge, M. V.; De Bildt, A. A.; Van Engeland, H.; Minderaa, R. B.

2008-01-01

Background: Results from several studies indicated that a symptom model other than the DSM triad might better describe symptom domains of autism. The present study focused on a) investigating the stability of a new symptom model for autism by cross-validating it in an independent sample and b) examining the invariance of the model regarding three…

Validation of carcass lesions as indicators for on-farm health and welfare of pigs.

PubMed

van Staaveren, N; Doyle, B; Manzanilla, E G; Calderón Díaz, J A; Hanlon, A; Boyle, L A

2017-04-01

Incorporating indicators for pig health and welfare at meat inspection could reduce the need for on-farm assessments. Skin and tail lesions are important welfare indicators in pigs with good potential to record during meat inspection and could possibly function as iceberg indicators of on farm welfare. The aim of this study was to validate the use of these carcass lesions at meat inspection for the assessment of pig health and welfare on farm. Thirty-one farrow-to-finish pig farms (∼12% of Irish herds) were assessed using an adapted version of the Welfare Quality protocol by inspecting 6 randomly selected pens of pigs in the first weaner (4 to 8 wk), second weaner (8 to 13 wk) and finisher stage (13 to 23 wk). The average prevalence of welfare outcomes for each stage was calculated. One batch of pigs was observed at slaughter and skin and tail lesions were scored according to severity for each carcass. The average prevalence of carcass lesion outcomes was calculated for each farm. Linear regression models were developed to predict the prevalence of each welfare outcome in each stage based on the prevalence of the different carcass lesions. The welfare outcomes of different welfare aspects that were best predicted by abattoir information (highest ) were poor body condition (first weaner stage), bursitis (second weaner stage), huddling (first weaner stage), severe tail lesions (finisher stage) and coughing (second weaner stage). Regression trees and receiver-operating curves (ROC) were used to evaluate the usefulness of carcass lesions as monitoring tools. Receiver-operating curves were created using the 75th percentile to classify farms as a problem farm for these welfare outcomes. Cut-off values of predictive carcass lesion prevalence were similar using both techniques. Models for predicting problem farms with poor body condition, bursitis and severe tail lesions were moderately accurate. Sensitivity and specificity ranged from 75 to 100% and 70 to 87

Validity of three asthma-specific quality of life questionnaires: the patients' perspective

PubMed Central

Jones, Christina J; Frew, Anthony; Smith, Helen

2016-01-01

Objectives It is not known which of the many asthma-specific quality of life (QoL) questionnaires best capture the lived experience of people with asthma. The objective of this study was to explore patients' views of three commonly used asthma-specific QoL questionnaires. Design Qualitative study using semistructured interviews. Setting Primary and secondary care in Brighton and Hove, UK. Participants 30 adult people with a physician-diagnosis of asthma who were asked to complete the Juniper Asthma Quality of Life Questionnaire (AQLQ-J), the Sydney Asthma Quality of Life Questionnaire (AQLQ-S) and the Living with Asthma Questionnaire (LWAQ) to elicit their views on the content validity of these. Results Thematic content analysis revealed a lack of congruence between the concerns of people with asthma and the questionnaire content in terms of missing (eg, allergies) and irrelevant (eg, smoky restaurants) content. The AQLQ-J was perceived as a ‘narrow’, ‘medical’ questionnaire focused on symptoms, the environment and functional ability. In contrast, the LWAQ and the AQLQ-S were perceived to be ‘non-medical’. The LWAQ was described as a ‘test’ and as a wide-ranging, embracing and holistic questionnaire. Its strong emotional focus was irritating to some. The AQLQ-S was described as a simple, quick and easy questionnaire, although there was a perception that it was lacking in depth. Conclusions Patient interviews highlighted strengths and shortcomings in the content validity of these three asthma-specific questionnaires. For patients, the AQLQ-S content seemed to be the most pertinent in its adequacy of coverage of medical, social and emotional aspects of health-related QoL in asthma. PMID:28007706

Validity of a New Patient Engagement Measure: The Altarum Consumer Engagement (ACE) Measure.

PubMed

Duke, Christopher C; Lynch, Wendy D; Smith, Brad; Winstanley, Julie

2015-12-01

The objective of this study was to report on the validation of new scales [called the Altarum Consumer Engagement (ACE) Measure] that are indicative of an individual's engagement in health and healthcare decisions. The instrument was created to broaden the scope of how engagement is measured and understood, and to update the concept of engagement to include modern information sources, such as online health resources and ratings of providers and patient health. Data were collected through an online survey with a US population of 2079 participants. A combination of Principal Component Analysis (PCA) and detailed Rasch analyses were conducted to identify specific subscales of engagement. Results were compared to another commonly used survey instrument, and outcomes were compared for construct validity. The PCA identified a four-factor structure composed of 21 items. The factors were named Commitment, Informed Choice, Navigation, and Ownership. Rasch analyses confirmed scale stability. Relevant outcomes were correlated in the expected direction, such as health status, lifestyle behaviors, medication adherence, and observed expected group differences. This study confirmed the validity of the new ACE Measure and its utility in screening for and finding group differences in activities related to patient engagement and health consumerism, such as using provider comparison tools and asking about medical costs.

DEVELOPMENT AND VALIDATION OF ANALYTICAL METHODS FOR ENUMERATION OF FECAL INDICATORS AND EMERGING CHEMICAL CONTAMINANTS IN BIOSOLIDS

EPA Science Inventory

In 2002 the National Research Council (NRC) issued a report which identified a number of issues regarding biosolids land application practices and pointed out the need for improved and validated analytical techniques for regulated indicator organisms and pathogens. They also call...

Validation of the Filovirus Plaque Assay for Use in Preclinical Studies

PubMed Central

Shurtleff, Amy C.; Bloomfield, Holly A.; Mort, Shannon; Orr, Steven A.; Audet, Brian; Whitaker, Thomas; Richards, Michelle J.; Bavari, Sina

2016-01-01

A plaque assay for quantitating filoviruses in virus stocks, prepared viral challenge inocula and samples from research animals has recently been fully characterized and standardized for use across multiple institutions performing Biosafety Level 4 (BSL-4) studies. After standardization studies were completed, Good Laboratory Practices (GLP)-compliant plaque assay method validation studies to demonstrate suitability for reliable and reproducible measurement of the Marburg Virus Angola (MARV) variant and Ebola Virus Kikwit (EBOV) variant commenced at the United States Army Medical Research Institute of Infectious Diseases (USAMRIID). The validation parameters tested included accuracy, precision, linearity, robustness, stability of the virus stocks and system suitability. The MARV and EBOV assays were confirmed to be accurate to ±0.5 log10 PFU/mL. Repeatability precision, intermediate precision and reproducibility precision were sufficient to return viral titers with a coefficient of variation (%CV) of ≤30%, deemed acceptable variation for a cell-based bioassay. Intraclass correlation statistical techniques for the evaluation of the assay’s precision when the same plaques were quantitated by two analysts returned values passing the acceptance criteria, indicating high agreement between analysts. The assay was shown to be accurate and specific when run on Nonhuman Primates (NHP) serum and plasma samples diluted in plaque assay medium, with negligible matrix effects. Virus stocks demonstrated stability for freeze-thaw cycles typical of normal usage during assay retests. The results demonstrated that the EBOV and MARV plaque assays are accurate, precise and robust for filovirus titration in samples associated with the performance of GLP animal model studies. PMID:27110807

Assessment of a condition-specific quality-of-life measure for patients with developmentally absent teeth: validity and reliability testing.

PubMed

Akram, A J; Ireland, A J; Postlethwaite, K C; Sandy, J R; Jerreat, A S

2013-11-01

This article describes the process of validity and reliability testing of a condition-specific quality-of-life measure for patients with hypodontia presenting for orthodontic treatment. The development of the instrument is described in a previous article. Royal Devon and Exeter NHS Foundation Trust & Musgrove Park Hospital, Taunton. The child perception questionnaire was used as a standard against which to test criterion validity. The Bland and Altman method was used to check agreement between the two questionnaires. Construct validity was tested using principal component analysis on the four sections of the questionnaire. Test-retest reliability was tested using intraclass correlation coefficient and Bland and Altman method. Cronbach's alpha was used to test internal consistency reliability. Overall the questionnaire showed good reliability, criterion and construct validity. This together with previous evidence of good face and content validity suggests that the instrument may prove useful in clinical practice and further research. This study has demonstrated that the newly developed condition-specific quality-of-life questionnaire is both valid and reliable for use in young patients with hypodontia. © 2013 John Wiley & Sons A/S. Published by Blackwell Publishing Ltd.

International validation of quality indicators for evaluating priority setting in low income countries: process and key lessons.

PubMed

Kapiriri, Lydia

2017-06-19

While there have been efforts to develop frameworks to guide healthcare priority setting; there has been limited focus on evaluation frameworks. Moreover, while the few frameworks identify quality indicators for successful priority setting, they do not provide the users with strategies to verify these indicators. Kapiriri and Martin (Health Care Anal 18:129-147, 2010) developed a framework for evaluating priority setting in low and middle income countries. This framework provides BOTH parameters for successful priority setting and proposes means of their verification. Before its use in real life contexts, this paper presents results from a validation process of the framework. The framework validation involved 53 policy makers and priority setting researchers at the global, national and sub-national levels (in Uganda). They were requested to indicate the relative importance of the proposed parameters as well as the feasibility of obtaining the related information. We also pilot tested the proposed means of verification. Almost all the respondents evaluated all the parameters, including the contextual factors, as 'very important'. However, some respondents at the global level thought 'presence of incentives to comply', 'reduced disagreements', 'increased public understanding,' 'improved institutional accountability' and 'meeting the ministry of health objectives', which could be a reflection of their levels of decision making. All the proposed means of verification were assessed as feasible with the exception of meeting observations which would require an insider. These findings results were consistent with those obtained from the pilot testing. These findings are relevant to policy makers and researchers involved in priority setting in low and middle income countries. To the best of our knowledge, this is one of the few initiatives that has involved potential users of a framework (at the global and in a Low Income Country) in its validation. The favorable validation

Measuring disability: a systematic review of the validity and reliability of the Global Activity Limitations Indicator (GALI).

PubMed

Van Oyen, Herman; Bogaert, Petronille; Yokota, Renata T C; Berger, Nicolas

2018-01-01

GALI or Global Activity Limitation Indicator is a global survey instrument measuring participation restriction. GALI is the measure underlying the European indicator Healthy Life Years (HLY). Gali has a substantial policy use within the EU and its Member States. The objective of current paper is to bring together what is known from published manuscripts on the validity and the reliability of GALI. Following the PRISMA guidelines, two search strategies (PUBMED, Google Scholar) were combined to identify manuscripts published in English with publication date 2000 or beyond. Articles were classified as reliability studies, concurrent or predictive validity studies, in national or international populations. Four cross-sectional studies (of which 2 international) studied how GALI relates to other health measures (concurrent validity). A dose-response effect by GALI severity level on the association with the other health status measures was observed in the national studies. The 2 international studies (SHARE, EHIS) concluded that the odds of reporting participation restriction was higher in subjects with self-reported or observed functional limitations. In SHARE, the size of the Odds Ratio's (ORs) in the different countries was homogeneous, while in EHIS the size of the ORs varied more strongly. For the predictive validity, subjects were followed over time (4 studies of which one international). GALI proved, both in national and international data, to be a consistent predictor of future health outcomes both in terms of mortality and health care expenditure. As predictors of mortality, the two distinct health concepts, self-rated health and GALI, acted independently and complementary of each other. The one reliability study identified reported a sufficient reliability of GALI. GALI as inclusive one question instrument fits all conceptual characteristics specified for a global measure on participation restriction. In none of the studies, included in the review, there was

Wavelet Filtering to Reduce Conservatism in Aeroservoelastic Robust Stability Margins

NASA Technical Reports Server (NTRS)

Brenner, Marty; Lind, Rick

1998-01-01

Wavelet analysis for filtering and system identification was used to improve the estimation of aeroservoelastic stability margins. The conservatism of the robust stability margins was reduced with parametric and nonparametric time-frequency analysis of flight data in the model validation process. Nonparametric wavelet processing of data was used to reduce the effects of external desirableness and unmodeled dynamics. Parametric estimates of modal stability were also extracted using the wavelet transform. Computation of robust stability margins for stability boundary prediction depends on uncertainty descriptions derived from the data for model validation. F-18 high Alpha Research Vehicle aeroservoelastic flight test data demonstrated improved robust stability prediction by extension of the stability boundary beyond the flight regime.

Selecting clinical quality indicators for laboratory medicine.

PubMed

Barth, Julian H

2012-05-01

Quality in laboratory medicine is often described as doing the right test at the right time for the right person. Laboratory processes currently operate under the oversight of an accreditation body which gives confidence that the process is good. However, there are aspects of quality that are not measured by these processes. These are largely focused on ensuring that the most clinically appropriate test is performed and interpreted correctly. Clinical quality indicators were selected through a two-phase process. Firstly, a series of focus groups of clinical scientists were held with the aim of developing a list of quality indicators. These were subsequently ranked in order by an expert panel of primary and secondary care physicians. The 10 top indicators included the communication of critical results, comprehensive education to all users and adequate quality assurance for point-of-care testing. Laboratories should ensure their tests are used to national standards, that they have clinical utility, are calibrated to national standards and have long-term stability for chronic disease management. Laboratories should have error logs and demonstrate evidence of measures introduced to reduce chances of similar future errors. Laboratories should make a formal scientific evaluation of analytical quality. This paper describes the process of selection of quality indicators for laboratory medicine that have been validated sequentially by deliverers and users of the service. They now need to be converted into measureable variables related to outcome and validated in practice.

A comparative study between three stability indicating spectrophotometric methods for the determination of diatrizoate sodium in presence of its cytotoxic degradation product based on two-wavelength selection

NASA Astrophysics Data System (ADS)

Riad, Safaa M.; El-Rahman, Mohamed K. Abd; Fawaz, Esraa M.; Shehata, Mostafa A.

2015-06-01

Three sensitive, selective, and precise stability indicating spectrophotometric methods for the determination of the X-ray contrast agent, diatrizoate sodium (DTA) in the presence of its acidic degradation product (highly cytotoxic 3,5-diamino metabolite) and in pharmaceutical formulation, were developed and validated. The first method is ratio difference, the second one is the bivariate method, and the third one is the dual wavelength method. The calibration curves for the three proposed methods are linear over a concentration range of 2-24 μg/mL. The selectivity of the proposed methods was tested using laboratory prepared mixtures. The proposed methods have been successfully applied to the analysis of DTA in pharmaceutical dosage forms without interference from other dosage form additives. The results were statistically compared with the official US pharmacopeial method. No significant difference for either accuracy or precision was observed.

NIKE: a new clinical tool for establishing levels of indications for cataract surgery.

PubMed

Lundström, Mats; Albrecht, Susanne; Håkansson, Ingemar; Lorefors, Ragnhild; Ohlsson, Sven; Polland, Werner; Schmid, Andrea; Svensson, Göran; Wendel, Eva

2006-08-01

The purpose of this study was to construct a new clinical tool for establishing levels of indications for cataract surgery, and to validate this tool. Teams from nine eye clinics reached an agreement about the need to develop a clinical tool for setting levels of indications for cataract surgery and about the items that should be included in the tool. The tool was to be called 'NIKE' (Nationell Indikationsmodell för Kataraktextraktion). The Canadian Cataract Priority Criteria Tool served as a model for the NIKE tool, which was modified for Swedish conditions. Items included in the tool were visual acuity of both eyes, patients' perceived difficulties in day-to-day life, cataract symptoms, the ability to live independently, and medical/ophthalmic reasons for surgery. The tool was validated and tested in 343 cataract surgery patients. Validity, stability and reliability were tested and the outcome of surgery was studied in relation to the indication setting. Four indication groups (IGs) were suggested. The group with the greatest indications for surgery was named group 1 and that with the lowest, group 4. Validity was proved to be good. Surgery had the greatest impact on the group with the highest indications for surgery. Test-retest reliability test and interexaminer tests of indication settings showed statistically significant intraclass correlations (intraclass correlation coefficients [ICCs] 0.526 and 0.923, respectively). A new clinical tool for indication setting in cataract surgery is presented. This tool, the NIKE, takes into account both visual acuity and the patient's perceived problems in day-to-day life because of cataract. The tool seems to be stable and reliable and neutral towards different examiners.

[Correspondence analysis between traditional commercial specifications and quantitative quality indices of Notopterygii Rhizoma et Radix].

PubMed

Jiang, Shun-Yuan; Sun, Hong-Bing; Sun, Hui; Ma, Yu-Ying; Chen, Hong-Yu; Zhu, Wen-Tao; Zhou, Yi

2016-03-01

This paper aims to explore a comprehensive assessment method combined traditional Chinese medicinal material specifications with quantitative quality indicators. Seventy-six samples of Notopterygii Rhizoma et Radix were collected on market and at producing areas. Traditional commercial specifications were described and assigned, and 10 chemical components and volatile oils were determined for each sample. Cluster analysis, Fisher discriminant analysis and correspondence analysis were used to establish the relationship between the traditional qualitative commercial specifications and quantitative chemical indices for comprehensive evaluating quality of medicinal materials, and quantitative classification of commercial grade and quality grade. A herb quality index (HQI) including traditional commercial specifications and chemical components for quantitative grade classification were established, and corresponding discriminant function were figured out for precise determination of quality grade and sub-grade of Notopterygii Rhizoma et Radix. The result showed that notopterol, isoimperatorin and volatile oil were the major components for determination of chemical quality, and their dividing values were specified for every grade and sub-grade of the commercial materials of Notopterygii Rhizoma et Radix. According to the result, essential relationship between traditional medicinal indicators, qualitative commercial specifications, and quantitative chemical composition indicators can be examined by K-mean cluster, Fisher discriminant analysis and correspondence analysis, which provide a new method for comprehensive quantitative evaluation of traditional Chinese medicine quality integrated traditional commodity specifications and quantitative modern chemical index. Copyright© by the Chinese Pharmaceutical Association.

Additional Evidence for the Reliability and Validity of the Student Risk Screening Scale at the High School Level: A Replication and Extension

ERIC Educational Resources Information Center

Lane, Kathleen Lynne; Oakes, Wendy P.; Ennis, Robin Parks; Cox, Meredith Lucille; Schatschneider, Christopher; Lambert, Warren

2013-01-01

This study reports findings from a validation study of the Student Risk Screening Scale for use with 9th- through 12th-grade students (N = 1854) attending a rural fringe school. Results indicated high internal consistency, test-retest stability, and inter-rater reliability. Predictive validity was established across two academic years, with Spring…

Stability of extemporaneously prepared preservative-free prochlorperazine nasal spray.

PubMed

Yellepeddi, Venkata K

2018-01-01

The stability of an extemporaneously prepared preservative-free prochlorperazine 5-mg/mL nasal spray was evaluated. The preservative-free prochlorperazine nasal spray was prepared by adding 250 mg of prochlorperazine edisylate to 50 mL of citrate buffer in a low-density polyethylene nasal spray bottle. A stability-indicating high-performance liquid chromatography (HPLC) method was developed and validated using the major degradant prochlorperazine sulfoxide and by performing forced-degradation studies. For chemical stability studies, 3 100-μL samples of the preservative-free prochlorperazine from 5 nasal spray bottles stored at room temperature were collected at days 0, 20, 30, 45, and 60 and were assayed in triplicate using the stability-indicating HPLC method. Microbiological testing involved antimicrobial effectiveness testing based on United States Pharmacopeia ( USP ) chapter 51 and quantitative microbiological enumeration of aerobic bacteria, yeasts, and mold based on USP chapter 61. Samples for microbiological testing were collected at days 0, 30, and 60. The stability-indicating HPLC method clearly identified the degradation product prochlorperazine sulfoxide without interference from prochlorperazine. All tested solutions retained over 90% of the initial prochlorperazine concentration for the 60-day study period. There were no detectable changes in color, pH, and viscosity in any sample. There was no growth of bacteria, yeast, and mold for 60 days in all samples tested. An extemporaneously prepared preservative-free nasal spray solution of prochlorperazine edisylate 5 mg/mL was physically, chemically, and microbiologically stable for 60 days when stored at room temperature in low-density polyethylene bottles. Copyright © 2018 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

Bioassessment in nonperennial streams: Hydrologic stability influences assessment validity

NASA Astrophysics Data System (ADS)

Mazor, R. D.; Stein, E. D.; Schiff, K.; Ode, P.; Rehn, A.

2011-12-01

Nonperennial streams pose a challenge for bioassessment, as assessment tools developed in perennial streams may not work in these systems. For example, indices of biotic integrity (IBIs) developed in perennial streams may give improper indications of impairment in nonperennial streams, or may be unstable. We sampled benthic macroinvertebrates from 12 nonperennial streams in southern California. In addition, we deployed loggers to obtain continuous measures of flow. 3 sites were revisited over 2 years. For each site, we calculated several metrics, IBIs, and O/E scores to determine if assessments were consistent and valid throughout the summer. Hydrology varied widely among the streams, with several streams drying between sampling events. IBIs suggested good ecological health at the beginning of the study, but declined sharply at some sites. Multivariate ordination suggested that, despite differences among sites, changes in community structure were similar, with shifts from Ephemeroptera, Plecoptera, and Trichoptera to Coleoptera and more tolerant organisms. Site revisits revealed a surprising level of variability, as 2 of the 3 revisited sites had perennial or near-perennial flow in the second year of sampling. IBI scores were more consistent in streams with stable hydrographs than in those with strongly intermittent hydrographs. These results suggest that nonperennial streams can be monitored successfully, but they may require short index periods and distinct metrics from those used in perennial streams. In addition, better approaches to mapping nonperennial streams are required.

Reliability and validity of Arabic translation of Medication Adherence Report Scale (MARS) and Beliefs about Medication Questionnaire (BMQ)–specific for use in children and their parents

PubMed Central

Alsous, Mervat; Alhalaiqa, Fadwa; Abu Farha, Rana; Abdel Jalil, Mariam; McElnay, James; Horne, Robert

2017-01-01

Objectives to evaluate the reliability and discriminant validity of Arabic translation of the Medication Adherence Report Scale (MARS) and the Beliefs about Medication Questionnaire-specific (BMQ-specific). Methods Having developed Arabic translations of the study instruments, a cross-sectional study was carried out between March and October 2015 in two multidisciplinary governmental hospitals in Jordan. An expert panel monitored the forward and backward translation of the MARS and BMQ. Standard Arabic was used (with no specific dialect inclusion) to allow greater generalisability across Arabic speaking countries. Once the Arabic translations of the questionnaires were developed they were tested for consistency, validity and reliability on a group of children with chronic diseases and their parents. Results A total of 258 parents and 208 children were included in the study. The median age of participated children and parents was 15 years and 42 years respectively. Principle component analysis of all questionnaires indicated that all had good construct validity as they clearly measured one construct. The questionnaires were deemed reliable based on the results of Cronbach alpha coefficient. Furthermore, reliability of the questionnaires was demonstrated by test-retest intraclass correlation coefficients (ICC) which ranged from good to excellent for all scales (ICC>0.706). The Pearson correlation coefficient ranged from 0.546–0.805 for the entire sample which indicated a significant moderate to strong positive correlation between MARS and BMQ items at time 1 and 2. Reported adherence was greater than 59% using MARS-children and MARS-parents scales, and was correlated with beliefs in necessity and independent of the concerns regarding medications. Conclusion The Arabic translations of both BMQ and MARS for use in children and their parents have good internal consistency and proved to be valid and reliable tools that can be used by researchers in clinical practice to

Stability indicating HPLC-DAD method for analysis of Ketorolac binary and ternary mixtures in eye drops: Quantitative analysis in rabbit aqueous humor.

PubMed

El Yazbi, Fawzy A; Hassan, Ekram M; Khamis, Essam F; Ragab, Marwa A A; Hamdy, Mohamed M A

2017-11-15

Ketorolac tromethamine (KTC) with phenylephrine hydrochloride (PHE) binary mixture (mixture 1) and their ternary mixture with chlorpheniramine maleate (CPM) (mixture 2) were analyzed using a validated HPLC-DAD method. The developed method was suitable for the in vitro as well as quantitative analysis of the targeted mixtures in rabbit aqueous humor. The analysis in dosage form (eye drops) was a stability indicating one at which drugs were separated from possible degradation products arising from different stress conditions (in vitro analysis). For analysis in aqueous humor, Guaifenesin (GUF) was used as internal standard and the method was validated according to FDA regulation for analysis in biological fluids. Agilent 5 HC-C18(2) 150×4.6mm was used as stationary phase with a gradient eluting solvent of 20mM phosphate buffer pH 4.6 containing 0.2% triethylamine and acetonitrile. The drugs were resolved with retention times of 2.41, 5.26, 7.92 and 9.64min for PHE, GUF, KTC and CPM, respectively. The method was sensitive and selective to analyze simultaneously the three drugs in presence of possible forced degradation products and dosage form excipients (in vitro analysis) and also with the internal standard, in presence of aqueous humor interferences (analysis in biological fluid), at a single wavelength (261nm). No extraction procedure was required for analysis in aqueous humor. The simplicity of the method emphasizes its capability to analyze the drugs in vivo (in rabbit aqueous humor) and in vitro (in pharmaceutical formulations). Copyright © 2017 Elsevier B.V. All rights reserved.

Development and in-house validation of the event-specific polymerase chain reaction detection methods for genetically modified soybean MON89788 based on the cloned integration flanking sequence.

PubMed

Liu, Jia; Guo, Jinchao; Zhang, Haibo; Li, Ning; Yang, Litao; Zhang, Dabing

2009-11-25

Various polymerase chain reaction (PCR) methods were developed for the execution of genetically modified organism (GMO) labeling policies, of which an event-specific PCR detection method based on the flanking sequence of exogenous integration is the primary trend in GMO detection due to its high specificity. In this study, the 5' and 3' flanking sequences of the exogenous integration of MON89788 soybean were revealed by thermal asymmetric interlaced PCR. The event-specific PCR primers and TaqMan probe were designed based upon the revealed 5' flanking sequence, and the qualitative and quantitative PCR assays were established employing these designed primers and probes. In qualitative PCR, the limit of detection (LOD) was about 0.01 ng of genomic DNA corresponding to 10 copies of haploid soybean genomic DNA. In the quantitative PCR assay, the LOD was as low as two haploid genome copies, and the limit of quantification was five haploid genome copies. Furthermore, the developed PCR methods were in-house validated by five researchers, and the validated results indicated that the developed event-specific PCR methods can be used for identification and quantification of MON89788 soybean and its derivates.

Temporary stabilization specification improvements.

DOT National Transportation Integrated Search

2014-09-01

Seed variety performance data for establishing temporary vegetative cover was collected at four Illinois locations : at four planting seasons. Current Illinois Department of Transportation (IDOT) standard specifications call for a : mixture of perenn...