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.
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.
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.
ObjectiveTo compare and evaluate the discrimination, validity, and reliability of different data envelopment analysis (DEA) models for measuring the effectiveness of models by selecting different input and output indicators of the model.MethodsData from health statistical reports and pilot program of diagnosis-related groups of tertiary hospitals in Hubei Province from 2017 to 2018 were used to analyze the discrimination, content and structure validity, and reliability of the models. Six DEA models were established by enriching the details of input and output on the basis of the input and output indicators of the conventional DEA model of hospitals.ResultsFrom the view of discrimination, the results of all models were left-skewed, the cost-efficiency model had the lowest left-skewed degree (skewness coefficient: -0.14) and was the flattest (kurtosis coefficient: -1.02). From the view of structure validity, the results of the cost-efficiency model were positively correlated with total weights, outpatient visits, and inpatient visits (r=0.328, 0.329, 0.315; P<0.05). From the perspective of content validity, the interpretation of model was more consistent with theory of production after revision of input and output indicators. From the view of reliability, the cost efficiency model had the largest correlation coefficient between the data of 2017 and 2018 (r=0.880, P<0.05).ConclusionsAfter refining the input and output indicators of the DEA model, the discrimination, validity, and reliability of the model are higher, and the results are more reasonable. Using indicators such as discrimination, validity, and reliability can measure the effectiveness of the DEA model, and then optimize the model by selecting different input and output indicators.
ObjectivesTo compare and analyze existing pharmaceutical economic evaluations quality assessment instruments, and to provide suggestions on how to choose the most appropriate instrument.MethodsPubMed, EMbase, ScienceDirect, Web of Science, CNKI, WanFang Data and VIP databases were electronically searched to collect studies on existing pharmaceutical economic evaluations quality assessment instruments from inception to December, 2017. Two reviewers independently screened literature, extracted data and analyzed studies in terms of items, design methods, scopes and characteristics.ResultsTwelve original checklists with good reliability and validity were found. The first quality assessment method was designed in 1987 and the latest one was published in 2013. The number of checklist items ranged from 11 to 61.ConclusionThere is no consolidated method for assessing the quality of pharmaceutical economics evaluations. Evaluators can choose appropriate evaluation tools according to the purpose, type and operability of evaluation.
Objective We aimed to develop a self-management assessment scale for children with epilepsy and test its reliability and validity. Methods A research group was established, and the items were revised through literature review, group discussion and pre-investigation, and 280 patients with epilepsy in children were included, and the reliability and validity of the scale were tested. Results 28 items in 4 dimensions were developed to form the scale, namely, knowledge and belief of diseases and medication, compliance of medication and treatment, self-efficacy of medication and obstacles of medication. Confirmatory factor analysis extracted four common factors with characteristic roots greater than 1, and the cumulative variance explanation rate was 65.639%. The factor load of all items is > 0.5. The overall Cronbach’s alpha is 0.880, and the coefficients in seven measurement dimensions are all greater than 0.8. Conclusion The self-management assessment scale for children’s epilepsy drugs has good reliability and validity, and can provide a measuring tool for the drug management of children’s epilepsy diseases.