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 evaluate the reliability and validity of the Quality of Working Life Scale (QWL7-32).
MethodsThe QWL7-32 scale was used to survey 487 drilling workers. The presence of chronic diseases was regarded as an effector for evaluating physical health, and the result of SCL-90 measurement was regarded as an effector for evaluating psychological health. The reliability and validity of the scale were statistically analyzed.
ResultsThe results of the Pearson correlation coefficient was 0.713, the Cronbach's alpha coefficient was 0.920, and the Splithalf reliability coefficient was 0.942. The result of confirmatory factor analysis showed that the construct validity of scale was good, and the accumulative rate of 7 variances was 62.59%. The results of correlation analysis and t test showed that the validity of scale criterion was also good. In QWL7-32 scale, each dimension showed a good correlation with its relevant item but poor correlation with any other items.
ConclusionThe QWL7-32 has a good reliability and validity.
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.
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.
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.
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.
Objective
To develop an evaluation tool for the screening of high risk population for oral complications in critically ill patients, which can be performed accurately and scientifically.
Methods
Basing on the related foreign oral assessment scale, combined with the method of brainstorming, expert consultation, method of clinical status and so on, the item pool of the assessment scale was determined. Five nursing experts and two oral experts assessed the content validity and 50 ICU nurses were tested. Then, the screening accuracy of the assessment scale was proved by application in 100 critically ill patients selected randomly.
Results
The Cronbach’s a coefficient of final version of the High Risk Assessment Scale for Oral Complications in Critically Ill Patients (including seven parts contents of oral health assessment and oral pH value test) was 0.815, the content validity index (Sr-CVI/Ave) was 0.932. The results of 50 nurses to the 91.2% assessment items of the assessment scale were very important and important. For screening related indicators of oral complications in high-risk patients, the sensitivity of the assessment scale was 97.53%, the specificity was 94.11%, the positive predictive value was 98.75%, the negative predictive value was 88.89%, and the crude agreement was 95%.
Conclusion
There are good reliability, validity and a high accuracy of screening test in the High Risk Assessment Scale for Oral Complications in Critically Ill Patients. It can be used for screening patients at high risk for oral complications in critically ill patients, and help clinical nurses to complete the oral health status of the critically ill patients quickly.
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 evaluate the reliability,validity and feasibility of a patient-reported outcomes (PRO) scale in the subjects with respiratory failure.
Methods364 patients with chronic respiratory failure and 97 healthy subjects were face-to-face interviewed by well-trained investigators,and the data of respiratory failure -PRO instrument were collected. The psychometric performance such as reliability,validity,responsiveness and clinical feasibility in the respiratory failure -PRO instrument was evaluated.
ResultsThe Cronbach's alpha coefficient of the respiratory failure -PRO instrument and each dimension were greater than 0.7. Factor analysis showed that the instrument had good construct validity. The scores of each of the facets and total scores between the patients and the healthy subjects were different. The recovery rate and the efficient rate of the questionnaire were more than 95%,and the time required to complete a questionnaire was within 15 minutes,indicating that the scale had a high clinical feasibility.
ConclusionThe respiratory failure -PRO instrument has good reliability,validity,responsiveness and clinical feasibility.
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.
