ObjectiveTo translate the King’s Brief Interstitial Lung Disease (K-BILD) to Chinese, so as to provide an well reliability and validity assessment instrument for health status of patients with interstitial lung disease.MethodsBrislin’s transition model, six expert’s panel and pre-survey were used for initial Chinese version of K-BILD. Items analysis, exploratory factor analysis (EFA), confirmatory factor analysis (CFA), internal consistency reliability and test-retest reliability were used for validity and reliability test with 122 respondents.ResultsTen-item Chinese version of K-BILD were proved to have great psychometric qualities, two factors were extracted by EFA, which could explain 63.35% of the total variance. Furthermore, the CFA demonstrates the fit indices of two-factors mode: χ2/df=0.797, RMSEA=0.000, NFI=0.848, IFI=1.048, CFI=1.000, TLI=1.071. Cronbach’s α and Guttman Split-half were 0.893 and 0.861, respectively. Besides, the test-retest reliability of the scale was 0.805.ConclusionThe Chinese version of K-BILD scale has good validity and reliability, which is applicable for health status assessment in patient with interstitial lung disease.
Objective Using the evidence-based management to manage the flexible endoscope based on the data collected by information means, to reduce the rate of serious faults and control maintenance costs. Methods From January 2017 to December 2018, we collected and analyzed the flexible endoscope data of the use, leak detection, washing and disinfection, and maintenance between 2015 and 2018 from the Gastroenterology Department of our hospital. Three main causes of flexible endoscope faults were found: delayed leak detection, irregular operation, and physical/chemical wastage. Management schemes (i.e., leak detection supervision, fault tracing, and reliability maintenance) were enacted according to these reasons. These schemes were improved continuously in the implementation. Finally, we calculated the changes of the fault rate of each grade and the maintenance cost. Results By two years management practice, compared with those from 2015 to 2016, the annual rates of grade A and grade C faults of flexible endoscope from 2017 to 2018 decreased by 10.3% and 16.7% respectively, and the annual average maintenance cost fell by 53.2%. Conclusions The maintenance costs of flexible endoscope could be effectively controlled by enacting and implementing a series of targeted management schemes based on the data from the root causes of faults applying the evidence-based management. Evidence-based management based on data has a broad application prospect in the management of medical equipment faults.
Objective To develop a behavioral assessment scale for medication management plans in women of childbearing age with epilepsy and to test its reliability and validity. Methods Based on the Theory of Planned Behavior, a pool of questionnaire items was initially drafted through literature review and focus group discussions. A two-round Delphi expert consultation was conducted with 15 experts to form a test version of the behavioral assessment scale for medication management plans in women of childbearing age with epilepsy (including 27 items and 5 dimensions). Convenience sampling was used to conduct surveys among women of childbearing age with epilepsy in some tertiary hospitals in Chuxiong, Shenzhen and Wuhan from February to May 2024 (the first time) and from June to October 2024 (the second time). ResultsThe effective recovery rates of the two rounds of questionnaires were 95.5% and 94.6%, respectively. The final scale included 24 items and 5 dimensions, with good reliability and validity: the content validity index (S-CVI) was 0.934, Cronbach's α coefficient was 0.876, split-half reliability was 0.819, and test-retest reliability was 0.901; exploratory factor analysis extracted 5 factors (cumulative variance explained rate 73.97%, item load 0.42~0.85), and confirmatory factor analysis showed that the model had good fit (χ2/df=1.849, RMSEA=0.075, CFI, GFI, AGFI, IFI, TLI all>0.85). Conclusion The scale meets the reliability and validity standards and can be used to assess the medication management plans and behaviors of women of childbearing age with epilepsy.
Active medical device is a kind of medical device which is widely used. In order to realize the goal of high-quality development, product with high reliability is a necessary requirement for the domestic active medical device industry. By means of literature research, data collection, field research, materials comprehensive combing and analysis, this paper systematically analyzes and studies the current situations and the existing problems of reliability and evaluation from the dimensions of Chinese active medical device industry policy, enterprise situation and evaluation method. In addition, by considering the technical characteristics of reliability work, concrete suggestions for solving the problems are given from the directions of standard and guiding principle, so as to provide reference for active medical device industry to develop scientific and objective reliability technical standard system and guiding principle, which are in accord with the current characteristics of Chinese active medical device industry and supervision.
ObjectiveThe purpose of this study was to translate the U-CEP scale into Chinese, and evaluate the reliability and validity of the Chinese version of the U-CEP, in order to provide a measurement and evaluation tool for clinical epidemiology education and research. MethodsThe U-CEP scale was translated and adapted using the Brislin translation model. A nationwide survey of clinicians was conducted using the Chinese version of the U-CEP. Item analysis, reliability analysis, and validity analysis were performed using SPSS 26.0 software. ResultsThe discriminant validity analysis showed that except for item 4, the critical value (CR) of the other twenty-four items differed significantly between high and low groups (P<0.01), with CR values ranging from 2.902 to 14.609. The ITCs of the 25 items were all positive, with 5 items having an ITC<0.15(20%), 2 items having ITC≥0.15~0.20 (8%), 6 items having ITC≥0.20~0.40 (24%) and 12 items having ITC≥0.40 (48%). In terms of reliability, the overall Cronbach’s α coefficient of the Chinese version of the U-CEP was 0.80, with Cronbach’s α coefficient ranging from 0.752 to 0.805 when deleting each item one by one. The test-retest reliability was 0.848 (P<0.001). The alternative-form reliability was 0.838 (P<0.001). In terms of validity, expert analysis showed that the content validity of the Chinese version of the U-CEP was good. The construct validity analysis showed that the cumulative contribution rate of the 25 items was 57.50%. No respondent scored full marks or zero marks, indicating that no ceiling or floor effects were found. There were statistically significant differences in the total scores among clinicians with different educational backgrounds or with or without systematic learning of relevant knowledge (P<0.05). ConclusionThe Chinese version of the U-CEP has good reliability and validity, as well as good cultural adaptability. It can effectively assess a physician's knowledge of clinical epidemiology.
ObjectiveTo formulate the Chinese version of Fear of Progression Questionnaire-Short Form/Caregiver Version (FoP-Q-SF/C) and examine the reliability and validity of the scale.MethodsA questionnaire survey of FoP-Q-SF/C was conducted among the caregivers of melanoma out-patients in West China Hospital of Sichuan University from June 2019 to March 2020. Convenient sampling method was adopted. The validity and reliability of the scale were analyzed.ResultsA total of 247 caregivers of melanoma out-patients were investigated by the FoP-Q-SF/C, and 101 valid questionnaires were finally collected. The Cronbach’s α of the FoP-Q-SF/C scale was 0.919, and the Guttman Split-Half coefficient was 0.906. Using exploratory factor analysis to extract 3 common factors, the cumulative explainable total variation was 73.964%. The model fit was as follows: chi-square/degree of freedom was 1.950, standardized root mean square residual was 0.067, goodness of fit index was 0.859, incremental fit index was 0.939, comparative fit index was 0.938, Tucker-Lewis index or non-normed fit index was 0.918, and the root-mean-square error of approximation was 0.097.ConclusionsThe FoP-Q-SF/C scale formulated in this study is divided into three dimensions, which has good reliability and validity, meanwhile, it is relatively simple and can be used to clinically screen melanoma caregivers’ FoP-Q-SF/C levels. However, the application of this scale in other diseases still needs further testing.
ObjectiveTo compare the performance of 36-item short form health survey (SF-36) and World Health Organization quality of life-bref (WHOQOL-Bref) in assessing quality of life (QOL) in patients with pulmonary tuberculosis (TB). MethodsThe WHOQOL-Bref questionnaire and the SF-36 questionnaire were administered to patients with tuberculosis undergoing treatment from July to September 2013. The statistical methods of reliability analysis, factor analysis and the Pearson correlation coefficient analysis were used. ResultsIt showed that the WHOQOL-Bref and the SF-36 both had good reliability (Cronbach α=0.863 and 0.920, respectively). Constructive validity of the two instruments were checked by factor analysis and the Pearson correlation coefficient analysis, which indicated that both the two instruments had good validity. Among scales measuring similar concepts, many subscales of the SF-36 and the four domains of the WHOQOL-Bref unexpectedly had a fair correlation with one another. For example, the physical QOL, psychological QOL, and social relation QOL domains of the WHOQOL-Bref and physical functioning, mental health, and social functioning of the SF-36 were 0.482, 0.745, and 0.572, respectively. ConclusionThe WHOQOL-Bref and the SF-36 have an approximately equivalent practicability in assessing the quality of life in patients with TB.
ObjectiveTo evaluate the reliability and validity of Guideline Implementation Success Assessment Tool (A-GIST). MethodsWith the guideline for the prevention and treatment of type 2 diabetes mellitus in China (2020 edition) as the target guideline, health care providers and patients from different hospitals across the country were investigated by questionnaire using A-GIST. Spearman-Brown coefficient and Cronbach's α coefficient were used to evaluate the split-half reliability and internal consistency reliability, while the structural validity, convergent validity and discriminant validity were investigated by confirmatory factor analysis based on structural equation. ResultsThe internal consistency reliability and split half reliability coefficients of the whole tool and each dimension ranged from 0.650 to 0.986. The scale-level content validity index (S-CVI/Ave) of content validity was 0.846. Confirmatory factor analysis showed that, the χ2/df of two sections of the tool were 8.695 and 6.123, respectively. The root mean square residual (RMR), the standard root mean square residual (SRMR) and the root mean square error of approximation (RMSEA) were under or almost under the threshold. Besides, the goodness-of-fit index (GFI) of them were 0.901 and 0.822, the adjusted goodness-of-fit index (AGFI) were 0.836 and 0.787, and the parsimonious normed fit index (PNFI) were 0.545 and 0.788, respectively. ConclusionGuideline Implementation Success Assessment Tool (A-GIST) was proved to be valid and reliable, and it shows that it is necessary to optimize the items under the dimensions of maintenance and evaluation of diagnosis and treatment effect in the future.
The COSMIN-RoB checklist includes three sections with a total of 10 boxes, which is used to evaluate risk of bias of studies on content validity, internal structure, and other measurement properties. COSMIN classifies reliability, measurement error, criteria validity, hypothesis testing for construct validity, and responsiveness as other measurement properties, which primarily focus on the quality of the (sub)scale as a whole, rather than on the item level. Among the five measurement properties, reliability, measurement error and criteria validity are the most widely used in the studies. Therefore, this paper aims to interpret COSMIN-RoB checklist with examples to guide researchers to evaluate the risk of bias of the studies on reliability, measurement error and criteria validity of PROMs.
ObjectiveTo evaluate the reliability and validity of the instrument of clinical applicability of guidelines (version 2.0). MethodsThe experts of domestic medical institutions were investigated by questionnaire, and the instrument of clinical applicability of guidelines (version 2.0) were evaluated the guidelines for the diagnosis and treatment of tinea mantis and tinea pedis (revised edition 2017) and the guidelines for the diagnosis and treatment of cerebral hemorrhage in China (2019). Using Cronbach's α coefficient and Spearman-Brown coefficient to evaluate the inherent reliability and split-half reliability. The content validity was evaluated by calculating the content validity index of the item level and the adjusted Kappa value. The correlation coefficient between each item and the dimension and the hypothesis test were used to evaluate the convergent and discriminant validity. The structural validity was evaluated by using structural equation model to evaluate the structural validity of the tool. ResultsThe Cronbach's α coefficient and Spearman-Brown coefficient of the instrument of clinical applicability of guidelines (version 2.0) were both greater than 0.7, the content validity index (S-CVI/Ave) were more than 0.8, the success rates of convergent were 100%, and the success rates of discriminant validity calibration were 100% and 96%. In the second-order confirmatory factor analysis model, the χ2/ df were less than 3, the fitting index (CFI), the goodness of fit index (GFI) and the adjustment goodness of fit index (AGFI) were all greater than 0.9. The root mean square residual (RMR) were all less than 0.05, and approximate error root mean square (RMSEA) were less than 0.09. The P value of RESEA hypothesis test were more than 0.05. ConclusionThe instrument of clinical applicability of guidelines (version 2.0) has good reliability and validity, which can be further verified in practical application in the future.