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.
The COSMIN community updated the COSMIN-RoB checklist on reliability and measurement error in 2021. The updated checklist can be applied to the assessment of all types of outcome measurement studies, including clinician-reported outcome measures (ClinPOMs), performance-basd outcome measurement instruments (PerFOMs), and laboratory values. In order to help readers better understand and apply the updated COSMIN-RoB checklist and provide methodological references for conducting systematic reviews of ClinPOMs, PerFOMs and laboratory values, this paper aimed to interpret the updated COSMIN-RoB checklist on reliability and measurement error studies.
ObjectiveTo develop a patient satisfaction evaluation scale for day surgery and test its reliability and validity, so as to provide a scientific and effective tool for day surgery patient satisfaction assessment.MethodsThe literature review method was used to form an entry pool, and the initial version of the scale was formed in conjunction with the expert review method. And then a preliminary survey was conducted to obtain the tentative version of the scale. Finally, 290 day surgery patients discharged between June 15th and July 15th, 2019 were selected to accomplish a survey to check the reliability and validity of the scale.ResultsFinally, a day surgery patient satisfaction evaluation scale was formed, containing 3 stages (pre-hospital, hospitalization, and postdischarge follow-up), 3 dimensions (medical staff evaluation, medical service evaluation, and environment and process evaluation), and 40 items. After the formal survey, the overall Cronbach’s α coefficient of the scale was 0.980, the Spearman-Brown coefficient was 0.933, the Guttman’s half-coefficient was 0.932, and the content validity was 0.87-1.00.ConclusionThe day surgery patient satisfaction evaluation scale was proven good reliability and validity, which can be used as a measurement tool for day surgery patients and applied to clinical practice.
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.
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.
ObjectiveTo develop a survey questionnaire on preferences and values regarding perineal injury prevention measures during pregnancy and conduct reliability and validity tests. MethodsCombining literature reviews, qualitative interviews, and expert consultations, we summarized key elements of perineal injury prevention during pregnancy and synthesized the best evidence. Through multiple discussions within the core working group, a survey questionnaire on preferences and values regarding perineal injury prevention measures during pregnancy was formulated. Using convenience sampling, pregnant women were recruited, and a pre-survey was conducted using the questionnaire. Pre-survey results were analyzed using item analysis and reliability and validity testing methods to validate and refine the questionnaire. ResultsThe questionnaire was compiled based on the theory of evidence-based decision-making. The initial version of the questionnaire was developed by combining systematic evaluation, network meta-analysis, and semi-structured interviews. The questionnaire was modified and improved through expert consultation, group discussion, and pre-investigation, which ensured that the questionnaire had good reliability, validity, and practicability. The Cronbach's α coefficient was 0.87, the split-half reliability was 0.71, and the content validity index was 0.97 of the survey questionnaire. ConclusionThe present version of the perineal injury preventive measures preference and values questionnaire has good reliability, validity, and practicability. It can serve as a valuable tool for investigating preferences and values related to perineal injury prevention during pregnancy.
ObjectivesThis study aimed to evaluate the validity and reliability of the clinical practice guidelines (CPGs) applicability evaluation tool, a preliminary revised tool, by using it to appraise specific clinical guidelines.MethodsMedical staffs were sampled from relevant departments in domestic medical institutions to use tool to evaluate the two guidelines. Spearman-Brown coefficient of odd-even split-half method and Cronbach's alpha coefficient were used to evaluate the split-half reliability and internal consistency reliability. The convergent and discriminant validity were evaluated by correlation analysis and correlation coefficient comparison hypothesis test, and the structural validity was investigated by confirmatory factor analysis based on structural equation.ResultsThe split-half reliability of the evaluation tool was 0.86, and the Cronbach's coefficient of the whole tool and each dimension were greater than 0.7 for two guidelines. The success rates of tool convergent and discriminant validity calibration were 100%. In the second-order confirmatory factor analysis model, the χ2 and df were 3.38 and 2.46, the comparative fit index (CFI) were 0.872 and 0.974, the goodness of fit index (GFI) were 0.954 and 0.983, and the adjusted goodness of fit index (AGFI) were 0.846 and 0.959 for two guidelines respectively. Both standard root mean square residual (SRMR) and root mean square error of approximation (RMSEA) were less than 0.09. Both P values of RMSEA hypothesis test were greater than 0.05.ConclusionsThe evaluation scale is a valid and reliable instrument for assessing the applicability of CPGs, which should be further evaluated in practical applications in the future.
ObjectiveTo conduct meta-analysis with the reliability of objective structured clinical examination (OSCE), so as to the reliability of OSCE used in the tests for evaluating clinical capacities of medical students. MethodsArticles about evaluating clinical capacities of medical students using OSCE and using comprehensive coefficient of Cronbach's α to measure the reliability of OSCE were electronically searched in PubMed, ScienceDirect, CNKI, WanFang data and VIP from Jan. 1998 to May. 2013. Two reviewers screened literature according to the inclusion and exclusion criteria, extracted data, and assessed the methodological quality of the included studies. Then meta-analysis was performed using SSPS 17.0 software. ResultsThirty-four studies involving 53 coefficients of Cronbach's α were included, of which, there were 18 articles written in English involving 28 coefficients of Cronbach's α and 16 articles written in Chinese involving 25 coefficients of Cronbach's α. The results of meta-analysis showed that:the total coefficient of Cronbach's α of OSCE was 0.700 (95%CI 0.660 to 0.737). The coefficient of Cronbach's α of internationally-published literature was 0.745 (95%CI 0.696 to 0.790) and that of nationally-published literature was 0.648 (95%CI 0.584 to 0.705), with a significant difference between two groups. ConclusionCurrently, the reliability of internationally/nationally-used OSCE is 0.7, which has relatively better reliability when used in the tests for evaluating clinical capacities of medical students at home and aboard. However, the reliability of OSCE at abroad is fairly better than that at home.
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.