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

Accuracy validation is essential to clinical application of medical image registration techniques. Registration validation remains a challenging problem in practice mainly due to lack of 'ground truth'.In this paper, an overview of current validation methods for medical image registration is presented with detailed discussion of their benefits and drawbacks.Special focus is on non-rigid registration validation. Promising solution is also discussed.
Algorithms ; Diagnostic Imaging ; Humans ; Image Interpretation, Computer-Assisted ; Phantoms, Imaging ; Validation Studies as Topic

It is imperative that any newly established bio-analytical method is validated thoroughly, using standardised parameters. The purpose of this article is to provide recommendations on how to validate a new bio-analytical method. Based on author's personal experience and some interesting discussion points from the conference of "International Association of Forensic Toxicologists" in 2007, the authors propose these essential requirements for validating a new analytical method. The key parameters of method validation include selectivity, linearity, accuracy, precision, LOD (limit of detection), LLOQ (the lower limit of quantitation), stability and the extraction recovery. For any bio-analytical method using LC-MSn (Liquid chromatography-mass spectrometry), studies of matrix effect should also be included in addition of the above parameters.
Chemistry Techniques, Analytical/standards* ; Chromatography, Liquid/methods* ; Forensic Toxicology ; Mass Spectrometry/methods* ; Reproducibility of Results ; Validation Studies as Topic

microRNAs (miRNAs) are 20-24 nucleotide (nt) RNAs that regulate eukaryotic gene expression post-transcriptionally by the degradation or translational inhibition of their target messenger RNAs (mRNAs). To identify miRNA target genes will help a lot by understanding their biological functions. Sophisticated computational approaches for miRNA target prediction, and effective biological techniques for validating these targets now play a central role in elucidating their functions. Owing to the imperfect complementarity of animal miRNAs with their targets, it is difficult to judge the accuracy of the prediction. Complexity of regulation by miRNA-mediated targets at protein and mRNAs levels has made it more challenging to identify the targets. To date, only a few miRNAs targets are confirmed. In this article, we review the methods of miRNA target prediction and the experimental validation for their corresponding mRNA targets in animals.
Animals ; Computational Biology ; methods ; Gene Expression Regulation ; Humans ; MicroRNAs ; genetics ; metabolism ; RNA, Messenger ; genetics ; metabolism ; Validation Studies as Topic

INTRODUCTIONOver the years, performance assessment (PA) has been widely employed in medical education, Objective Structured Clinical Examination (OSCE) being an excellent example. Typically, performance assessment involves multiple raters, and therefore, consistency among the scores provided by the auditors is a precondition to ensure the accuracy of the assessment. Inter-rater agreement and inter-rater reliability are two indices that are used to ensure such scoring consistency. This research primarily examined the relationship between inter-rater agreement and inter-rater reliability.

MATERIALS AND METHODSThis study used 3 sets of simulated data that was based on raters' evaluation of student performance to examine the relationship between inter-rater agreement and inter-rater reliability.

RESULTSData set 1 had high inter-rater agreement but low inter-rater reliability, data set 2 had high inter-rater reliability but low inter-rater agreement, and data set 3 had high inter-rater agreement and high inter-rater reliability.

CONCLUSIONInter-rater agreement and inter-rater reliability can but do not necessarily coexist. The presence of one does not guarantee that of the other. Inter-rater agreement and inter-rater reliability are both important for PA. The former shows stability of scores a student receives from different raters, while the latter shows the consistence of scores across different students from different raters.

Clinical Competence ; Curriculum ; Education, Medical ; Humans ; Psychometrics ; Reproducibility of Results ; Statistics as Topic ; Statistics, Nonparametric ; Students, Medical ; Task Performance and Analysis ; Validation Studies as Topic

BACKGROUND/AIMS: The Compliance Questionnaire-Rheumatology (CQR) is a validated scale to evaluate patient compliance for anti-rheumatic medications. We developed a Korean version of the CQR (KCQR) and confirmed its reliability and validity. METHODS: We prepared the KCQR by translating and back-translating the original CQR with modifications to adapt it to Korean culture. Fifty Korean patients with rheumatoid arthritis (RA) were enrolled in this study. The test-retest reliability of the KCQR was evaluated at a 2-week interval using the intraclass correlation coefficient (ICC). The validity of the KCQR was assessed by identifying associations between KCQR scores and patient compliance, measured using pharmacy refill data. RESULTS: The reliability of the KCQR was adequate, with an ICC of 0.71 for test-retest reliability. With respect to validity, the summed score of the weighted KCQR showed a significant correlation with pharmacy refill data (r2 = 0.57) on multiple regression analysis. CONCLUSIONS: Our results indicate that the KCQR is a reliable, valid instrument to evaluate compliance of Korean patients for RA medications.
Adaptation, Psychological ; Adult ; Aged ; Arthritis, Rheumatoid/*drug therapy ; Cross-Cultural Comparison ; Female ; Humans ; Korea ; Male ; *Medication Adherence ; Middle Aged ; *Questionnaires ; Reproducibility of Results ; Validation Studies as Topic

PURPOSE: This study examined the fitness of a path model on the relationship among stress, self-esteem, aggression, depression, suicidal ideation, and violent behavior for adolescents. METHODS: The subjects consisted of 1,177 adolescents. Data was collected through self-report questionnaires. The data was analyzed by the SPSS and AMOS programs. RESULTS: Stress, self-esteem, aggression, and depression showed a direct effect on suicidal ideation for adolescents, while stress, self-esteem, and aggression showed an indirect effect on suicidal ideation for adolescents. Stress, self-esteem, aggression, and suicidal ideation showed a direct effect on violent behavior for adolescents, while stress, self-esteem, aggression, and depression showed an indirect effect on violent behavior for adolescents. The modified path model of adolescent's suicidal ideation and violent behavior was proven correct. CONCLUSION: These results suggest that adolescent's suicidal ideation and violent behavior can be decreased by reducing stress, aggression, and depression and increasing self-esteem. Based on the outcomes of this study, it is necessary to design an intervention program that emphasizes reducing stress, aggression, and depression and increasing self-esteem in order to decrease adolescents' suicide ideation and violence.
Adolescent ; *Adolescent Psychology ; Aggression/psychology ; Female ; Humans ; Male ; *Models, Psychological ; Questionnaires ; Self Care ; Stress, Psychological ; Suicide/*psychology ; Validation Studies as Topic ; Violence/*psychology

BACKGROUND/AIMS: Nonalcoholic steatohepatitis (NASH) is commonly diagnosed using the semi-quantitative grading and staging system proposed by Brunt et al. in 1999. The Pathology Committee of the NASH established the nonalcoholic fatty liver diseases (NAFLD) activity score (NAS) in 2005. The aim of this study was to elucidate the validity and reliability of the NAS in Korean NAFLD patients. METHODS: Fifty-six patients on whom sonography-guided liver biopsy for well-defined NAFLD was performed between 1999 and 2007 were identified retrospectively. Two pathologists evaluated each biopsy sample. NAFLD was evaluated using both the grading system developed by Brunt et al. and the NAS. Each pathologist was blinded to the patients' clinical data and scored independently. We evaluated the body mass index (BMI), liver enzymes, lipid profile, peripheral insulin resistance, leptin, insulin/c-peptide ratio, ferritin, and fasting blood glucose. RESULTS: The patients were aged 32.1+/-12.5 years (mean+/-SD) and comprised 44 males (78.6%). Patients with different grades at the two grading systems had mild steatosis or ballooning changes with fibrosis, and 36.6% of them were borderline cases (NAS of 3 or 4). The interobserver agreement on diagnostic category was 0.748 (P<0.001) for the NAS (using weighted kappa statistics). Elevated fasting glucose, ALT, and triglyceride were associated with the NAS. CONCLUSIONS: The simple and reproducible NAS was found to be a useful pathologic grading system in Korean NAFLD patients. However, the proportion of borderline cases based on the NAS was high. The "wait and see" strategy is necessary for evaluating the long-term prognosis.
Adult ; Alanine Transaminase/blood ; Asian Continental Ancestry Group ; Blood Glucose/analysis ; Fatty Liver/*pathology/ultrasonography ; Female ; Ferritins/blood ; Fibrosis ; Humans ; Insulin Resistance ; Male ; Middle Aged ; Reproducibility of Results ; Republic of Korea ; Retrospective Studies ; *Severity of Illness Index ; Triglycerides/blood ; Validation Studies as Topic

OBJECTIVETo study the changes of pharmacokinetics of 6,7-dimethoxycoumarin in a rat model of alpha-naphthylisothiocyanate (ANIT)-induced experimental hepatic injury after oral administration of Yinchenhao Decoction (, YCHD) using an ultra pressure liquid chromatography (UPLC) method.

METHODSRats were divided into a normal group and a model group, after modeled by 4% ANIT (75 mg/kg) for 48 h, they were orally administrated with YCHD extract at the dose of 0.324 g/kg, and then blood was collected from their orbital sinus after different intervals. Changes in liver function were monitored by the levels of liver enzymes [alanine aminotransferase (ALT), aspartate aminotransferase (AST)] and bilirubins [total bilirubin (TBIL), direct bilirubin (DBIL)], the concentration of 6,7-dimethoxycoumarin in plasma were measured by UPLC, and the pharmaceutical parameters were calculated with DAS2.1.1 software.

RESULTSThe concentration-time curve of both normal and modeled rats after oral administration of YCHD was obtained. Their time to maximum plasma concentration (t(max)) were both 0.25 h, the maximum concentration (C(max)) were 4.533 μg/mL and 6.885 μg/mL, and their area under concentration-time curve (AUC)(0→24h) were 16.272 and 32.981, respectively. There was a 51.88% and 100.46% increase in C(max) and AUC(0-t) (P<0.05), but there showed a 45.52% and 92.93% reduction in clearance of drug and volum of distribution (P<0.05), respectively.

CONCLUSIONSHepatic injury could significantly influence the pharmacokinetics of 6,7-dimethoxycoumarin after oral administration of YCHD, the absorption and distribution process was accelerated in liver injured rats, but the metabolism and elimination process was slowed. And this may lead to a significant accumulation of 6,7-dimethoxycoumarin in the body.

1-Naphthylisothiocyanate ; Administration, Oral ; Animals ; Chemical and Drug Induced Liver Injury ; blood ; drug therapy ; metabolism ; physiopathology ; Coumarins ; blood ; pharmacokinetics ; Disease Models, Animal ; Drug Evaluation, Preclinical ; Drugs, Chinese Herbal ; administration & dosage ; pharmacokinetics ; therapeutic use ; Liver ; drug effects ; physiopathology ; Models, Biological ; Rats ; Rats, Sprague-Dawley ; Validation Studies as Topic

OBJECTIVETo obtain normal range of coronary artery diameter with body surface area (BSA) dynamic changes in normal children at different age.

METHODThe left main coronary artery (LCA), left anterior descending artery (LAD), left circumflex artery (LCX) and the right coronary artery (RCA) diameter were measured in 400 normal subjects from Chinese population aged 0 d to 18 years [(6.43 ± 4.45) years], using HP Sonos 5500 color Doppler ultrasonic system, according to the standard method of measuring the coronary artery diameter.

RESULT(1) The diameters of LCA, LAD, LCX and RCA in different age groups (0 d-12 months, -3 years, -6 years, -9 years, -12 years, -18 years) had significant differences (F = 61.688, 51.343, 46.375, 50.192, P < 0.01,all groups mean differences had significant differences, there was significant difference between every two groups, P < 0.05), there were no significant differences between male and female subjects (P > 0.05). (2) The correlation analyses showed that the diameter of LCA, LAD, LCX and RCA had significant linear correlations with age, height, weight and BSA (r ranged from 0.71 to 0.85, P < 0.01 ). (3) The regression analyses were respectively performed on the diameters of LCA, LAD, LCX and RCA with BSA to establish seven regression models. The coefficients were compared for each model, the best model was chosen to create a Z score calculator, tracing out the Z value curve, through clinical practice,we chose Z score within ± 2 as the coronary artery diameter's normal range for Chinese children.

CONCLUSIONCoronary artery diameter's Z score curve is effective and reliable, it provide objective basis for clinicians and sonographers to accurately and quickly diagnose the anomalies in diameter of coronary artery.

Adolescent ; Age Factors ; Aorta ; diagnostic imaging ; Body Height ; Body Surface Area ; Body Weight ; Child ; Child Development ; physiology ; Child, Preschool ; Coronary Vessels ; diagnostic imaging ; growth & development ; Echocardiography, Doppler ; methods ; Female ; Humans ; Infant ; Infant, Newborn ; Male ; Mucocutaneous Lymph Node Syndrome ; diagnostic imaging ; Reference Values ; Regression Analysis ; Validation Studies as Topic