OBJECTIVE: To evaluate the frequency and adequacy of statistical analyses in a general radiology journal when reporting a reliability analysis for a diagnostic test. MATERIALS AND METHODS: Sixty-three studies of diagnostic test accuracy (DTA) and 36 studies reporting reliability analyses published in the Korean Journal of Radiology between 2012 and 2016 were analyzed. Studies were judged using the methodological guidelines of the Radiological Society of North America-Quantitative Imaging Biomarkers Alliance (RSNA-QIBA), and COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) initiative. DTA studies were evaluated by nine editorial board members of the journal. Reliability studies were evaluated by study reviewers experienced with reliability analysis. RESULTS: Thirty-one (49.2%) of the 63 DTA studies did not include a reliability analysis when deemed necessary. Among the 36 reliability studies, proper statistical methods were used in all (5/5) studies dealing with dichotomous/nominal data, 46.7% (7/15) of studies dealing with ordinal data, and 95.2% (20/21) of studies dealing with continuous data. Statistical methods were described in sufficient detail regarding weighted kappa in 28.6% (2/7) of studies and regarding the model and assumptions of intraclass correlation coefficient in 35.3% (6/17) and 29.4% (5/17) of studies, respectively. Reliability parameters were used as if they were agreement parameters in 23.1% (3/13) of studies. Reproducibility and repeatability were used incorrectly in 20% (3/15) of studies. CONCLUSION: Greater attention to the importance of reporting reliability, thorough description of the related statistical methods, efforts not to neglect agreement parameters, and better use of relevant terminology is necessary.
Biomarkers ; Diagnostic Tests, Routine* ; Methods*

BACKGROUND: Recently, cardiopulmonary exercise testing (CPX) has become a popular diagnostic method for differentiating the main cause of exertional dyspnea or exercise limitation. We evaluated the difference in the CPX results according to interpretative algorithms and the methods of exercise in Korea. METHOD: Sixty-six patients with chronic lung disease and 48 adults with dyspneic symptoms, but with no abnormalities in a spirometry performed symptom limited CPX, were included in this study. The results were interpreted using both Wasserman's(WA) and Eschenbacher's algorithm (EA), and a comparison between both algorithms was made. Thirty-three healthy medical students performed the CPX with a cycle ergometer and treadmill. The results were interpreted with EA and the concurrenec in interpretations was evaluated according to the methods of exercise. RESULTS: 1. In patients with chronic lung disease, the overall concordance rate between the two algorithms was 63.6%. The concordance rates were 69.8% in patients with obstructive, 25.0% in those with restrictive, and 66.7% in those with mixed pulmonary insufficiency. In patients with dyspneic symptoms but normal findings in resting spirometry, the concordance rate was 60.4%. 2. In healthy medical students, in results interpreted with EA, the concordance rate between the cycle ergometer and treadmill exercise was 25.0%. CONCLUSION: Both interpretative algorithms and methods of exercise may affect the CPX results. In using CPX as a diagnostic test for the causes of dyspnea in the Korean population, the interpretative algorithms and method of exercise need to be standardized, and a predictive VO2max equation needs to be established.
Adult ; Diagnostic Tests, Routine ; Dyspnea ; Exercise Test* ; Humans ; Korea ; Lung Diseases ; Methods* ; Spirometry ; Students, Medical

Chromosomal microarray (CMA) is a high-resolution, high-throughput method of identifying submicroscopic genomic copy number variations (CNVs). CMA has been established as the first-line diagnostic test for individuals with developmental delay (DD), intellectual disability (ID), autism spectrum disorders (ASDs), and multiple congenital anomalies (MCAs). CMA analysis was performed in 42 Korean patients who had been diagnosed with unexplained DD, ID, ASDs, and MCAs. Clinically relevant CNVs were discovered in 28 patients. Variants of unknown significance were detected in 13 patients. The diagnostic yield was high (66.7%). CMA is a superior diagnostic tool compared with conventional karyotyping and fluorescent in situ hybridization.
Autism Spectrum Disorder* ; Autistic Disorder* ; Diagnostic Tests, Routine ; Humans ; In Situ Hybridization, Fluorescence ; Intellectual Disability* ; Karyotyping ; Methods

Real-time quaking-induced conversion (RT-QuIC) assay is a newly established PrP -detecting method. The development of RT-QuIC improves the diagnosis of sporadic Creutzfeldt-Jakob disease (sCJD), showing good sensitivity and specificity in many countries when the method was used in cerebrospinal fluid (CSF) samples. However, in China, the sensitivity and specificity of RT-QuIC has yet to be determined due to the lack of definitive diagnosis samples. Recently, 30 definitive sCJD and 30 non-CJD diagnoses were evaluated by RT-QuIC assay. In the 30 sCJD CSF samples, 29 showed positive results. By contrast, all the non-CJD samples were negative. The sensitivity and specificity of our RT-QuIC assay were 96.67% and 100%, respectively, and are comparable to other published data. Results can provide a fundamental basis for the usage of RT-QuIC assay in CJD surveillance in China.
China ; Creutzfeldt-Jakob Syndrome ; diagnosis ; Diagnostic Tests, Routine ; methods ; Humans ; PrPSc Proteins ; cerebrospinal fluid ; Sensitivity and Specificity

Point-of-care testing (POCT) is a test method performed on the sampling site or patient bedside. Accurate results can be achieved rapidly by the application of portable analytical instruments and compatible reagents. It has been widely used in the field of in vitro diagnosis (IVD). Paper-based microfluidics technology has great potential in developing POCT due to its advantages in low cost, simple operation, rapid detection, portable equipment, and unrestricted application conditions. In recent years, the development of paper-based microfluidic technology and its integration with various new technologies and methods have promoted the substantial development of POCT technology and methods. The classification and characteristic of the paper are summarized in this review. Paper-based microfluidic sample pretreatment methods, the flow control in the process of reaction and the signal detecting and analyzing methods for the testing results are introduced. The research progress of various kinds of microfluidic paper-based analytical devices (μPADs) toward POCT in recent years is reviewed. Finally, remaining problems and the future prospects in POCT application of paper-based microfluidics are discussed.
Diagnostic Tests, Routine ; methods ; Humans ; Microfluidic Analytical Techniques ; instrumentation ; Paper ; Point-of-Care Testing

PURPOSE: This study was undertaken to develop and test a mastery learning program of nursing skills for undergraduate nursing students. METHODS: In this methodological study, first, the preliminary draft of a mastery learning program to provide training for nursing skills was developed based on Bloom's framework for mastery learning. Second, to test the developed program, a single-blinded, nonequivalent control group nonsynchronized study was conducted on 50 senior nursing students in a University selected by convenient sampling. Thirteen students were assigned to a control group; 13, 12, and 13 of them were assigned to intravenous therapy, transfusion, and patient transfer groups, respectively. The achievement levels and performance scores of the selected nursing skills were measured before and after the completion of the program in all the groups. Lastly, the final program was confirmed based on the results of the program testing. RESULTS: Intravenous therapy, transfusion, and patient transfer were selected as essential nursing skills for the program based on the priorities rated by clinical instructors and staff nurses. The achievement levels of selected nursing skills were determined by Angoff scores. After participating in the program, the proportion of passers and performance scores of the nursing skills in the experimental groups were significantly higher than those in the control group. The final program was confirmed which included a diagnostic test, enrichment activities for the passers and three repetitions of corrective activities and formative assessments for non-passers. CONCLUSION: The results suggest that a mastery learning program for undergraduate students can lead to better improvement and performance of essential nursing skills.
Diagnostic Tests, Routine ; Humans ; Learning* ; Methods ; Nursing* ; Patient Transfer ; Program Development ; Students, Nursing*

Diagnostic Tests, Routine ; methods ; Humans ; Mycobacterium tuberculosis ; isolation & purification ; Sensitivity and Specificity ; Tuberculosis, Pulmonary ; diagnosis ; microbiology

BACKGROUND: Rotavirus is a major pathogen causing enteritis worldwide in children under five years of age. In recent years, immunochromatographic assay (ICA) has been widely used as a diagnostic test for rotavirus detection. This study aimed to compare and evaluate the performance of ICA-based rotavirus rapid test kits from two manufacturers. METHODS: Residual stool samples from a total of 130 children with acute enterocolitis from November 2017 to January 2018 were used. We compared the results of the two immunochromatographic methods (SD BIOLINE Rotavirus kit and GENEDIA Rotavirus Ag Rapid Test) with those of the currently used enzyme immunoassay method. RESULTS: Positive agreement, negative agreement, and total agreement rates between the SD BIOLINE rotavirus kit and the enzyme immunoassay were 98.0%, 100%, and 99.2%, respectively. Positive agreement, negative agreement, and total agreement rates between the GENEDIA Rotavirus Ag Rapid Test and the enzyme immunoassay were 96.0%, 100%, and 98.4%, respectively. CONCLUSIONS: Both rotavirus rapid test kits showed very good agreement with the conventional enzyme immunoassay. Therefore, it could be a useful test to detect rotavirus directly from stool samples in a short time.
Child ; Diagnostic Tests, Routine ; Enteritis ; Enterocolitis ; Humans ; Immunochromatography ; Immunoenzyme Techniques ; Methods ; Rotavirus

OBJECTIVETo present an integrated molecular biology dedicated system for tuberculosis diagnosis.

METHODSOne hundred and five sputum specimens from patients strongly suspected by clinical parameters of tuberculosis were studied by Ziehl-Neelsen staining, by cultivation on solid medium and by a balanced heminested fluorometric PCR system (Orange G3TB) that could preserve worker safety and produce a rather pure material free of potential inhibitors. DNA amplification was performed in a low cost tuberculosis termocycler-fluorometer. Produced double stranded DNA was flurometrically detected. The whole reaction was conducted in one single tube which would not be opened after adding the processed sample in order to minimize the risk of cross contamination with amplicons.

RESULTSThe assay was able to detect 30 bacillus per sample mL with 99.8% interassay variation coefficient. PCR was positive in 23 (21.9%) tested samples (21 of them were smear negative). In our study it showed a preliminary sensitivity of 94.5% for sputum and an overall specificity of 98.7%.

CONCLUSIONSTotal run time of the test is 4 h with 2.5 real working time. All PCR positive samples are also positive by microbiological culture and clinical criteria. Results show that it could be a very useful tool to increase detection efficiency of tuberculosis disease in low bacilus load samples. Furthermore, its low cost and friendly using make it feasible to run in poor regions.

Diagnostic Tests, Routine ; methods ; Humans ; Mycobacterium tuberculosis ; genetics ; isolation & purification ; Polymerase Chain Reaction ; methods ; Sputum ; microbiology ; Tuberculosis ; diagnosis ; microbiology

BACKGROUNDSyncope is a common clinical problem with multiple causes. Vasovagal syncope (VVS) is by far the most frequent cause of syncope in children and adolescents. The traditional diagnostic approach to VVS of children and adolescents is based on a series of tests to exclude all other causes, which is complex and time and medical resource consuming. Attempts have been made to develop a new cost-effective diagnostic approach to avoid these problems. This study aimed to compare the economic effectiveness and diagnostic value of the traditional diagnostic approach to VVS of children with a new diagnostic approach.

METHODSOne hundred and eighteen children diagnosed as VVS were divided into two groups according to the different diagnostic approaches. The diagnostic value of the two diagnostic approaches was then analyzed. Meanwhile, the costs of hospitalization, diagnostic testing and hospital stay were determined. Data were evaluated by the cost-minimization analysis.

RESULTSThe diagnostic value of the new diagnostic approach was similar to that of the traditional diagnostic approach (56.57% vs. 53.91%, P = 0.697). However, the cost of hospitalization per patient by the new diagnostic approach was (1507.08 ± 144.63) Yuan (RMB) which was less than that of the traditional diagnostic approach (2603.64 ± 208.19) Yuan. The costs of diagnostic tests per patient by the new diagnostic approach was (1256.04 ± 109.14) Yuan and by the traditional approach (2175.22 ± 153.32) Yuan.

CONCLUSIONCompared to the traditional diagnostic approach to diagnose VVS in children and adolescents, the new diagnostic approach is of a good economic value, and it should be popularized in clinical practice.

Adolescent ; Child ; Child, Preschool ; Cost-Benefit Analysis ; methods ; Diagnostic Tests, Routine ; economics ; Female ; Humans ; Male ; Syncope, Vasovagal ; diagnosis