Validation Studies

Objective: This study aims to establish the validity and reliability of the Malaytranslated version of the CES-D. Methods: This study employed a cross-sectional study design. The participants were female inmates (n=90) from local prisons which were selected based on purposive-selective sampling. The analyses include face validation, factor analysis, and reliability testing. A test-retest was conducted within a one-week interval. Results: The mean score for depression among the participants is 18.97 (SD=6.51). Further descriptive analysis showed that 58.9% of them scored above the mean score, which is considered high. Preliminary construct validation analysis confirmed that factor analysis was appropriate for the Malay-translated version of the CES-D. Furthermore, the factor analysis showed similar factor loadings to the original English version. The total internal consistency of the translated version, which was measured by Cronbach’s alpha coefficient, was equal to 0.75. The test-retest reliability of the total score, measured by Pearson’s correlation was equal to 0.69. Conclusions: Face validity, construct validity, and reliability analysis were found satisfactory for the Malay-translated version of the CES-D. The Malay-translated version of the CES-D was found valid and reliable to be used in future studies, with comparable properties to the original version and to previous studies.
Depression ; Female ; Prisons ; Validation Studies

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

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

PURPOSE: The purpose of this study was to develop dedicated software for quantitative analysis of the airways and to validate the software using airway phantoms and excised swine lung. MATERIALS AND METHODS: The dedicated software was validated in airway phantoms and excised swine lung through comparison of the actual values with the measurements acquired with dedicated software. The accuracy of the measurements according to the reconstruction methods (standard, lung, sharp) and spatial resolution were compared using airway phantoms. Repeatability of the measurement of airway phantoms was assessed with follow-up CT scans three months later. RESULTS: Airway dimension measurements obtained in airway phantoms and excised swine lung showed good agreements with actual values. Airway measurements were more accurate when the sharp reconstruction algorithm was used and when the spatial resolution was improved using pixels smaller than conventional size. There was good agreement between the initial airway measurements and those obtained three months later. CONCLUSION: We developed and validated dedicated software for quantitative airway measurement. Recon-struction with sharp algorithms and high spatial resolution images is recommended for obtaining airway measurements.
Bronchi ; Follow-Up Studies ; Lung ; Phantoms, Imaging ; Software Validation ; Swine ; Tomography, X-Ray Computed

OBJECTIVES: The study aims to develop and validate a health-related quality of life (HRQoL) questionnaire for adult Filipinos with differentiated thyroid cancer (DTC) that can be used in combination with the European Organization for Research and Treatment of Cancer QLQ-C30 Questionnaire.
METHODOLOGY: The study had 4 phases. Phase I involved generation of HRQoL issues from literature review, focus group discussions with 6 DTC patients and 5 health care professionals (HCP). Subsequent assessment for relevance and importance of the HRQoL issues by 20 patients and HCP panel was done. Phase II was formulation of the HRQoL issues into questionnaire and subsequent translation into Filipino. Phase III was pilot testing of the questionnaire in 15 patients. Phase IV was validation of the pre-final questionnaire in 231 patients.
RESULTS: In Phase I, 28 HRQoL issues were generated. In Phase II, a 28-item Filipino questionnaire was created. In Phase III, 22 items that were not upsetting or confusing to patients and with good range of responses were retained. After Phase IV, a 22-item questionnaire with 5 conceptual scales (perceived fears, psychological distress/anxiety, functionality, voice complaints, neck complaints) was created.
CONCLUSIONS: The developed and validated 22-item questionnaire can be used to assess HRQoL issues in adult Filipinos with DTC.

Human ; Male ; Thyroid Gland ; Neoplasms ; Quality Of Life ; Philippines ; Validation Studies ; Patients ; Anxiety

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

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

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

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