Patient-reported outcome measures (PROM) measure attribute studies refer to studies conducted by investigators to validate the measurement attributes of PROM. The consensus-based standards for the selection of health measurement instruments (COSMIN), an international consensus standard for the selection of health measurement instruments, divides this attribute into three aspects: reliability, validity and responsiveness, and adds interpretability as an additional important feature for evaluating PROM. The purpose of this paper is to introduce the verification methods and principles of the three major measurement attributes in the COSMIN consensus, as well as the significance and direction of interpretability evaluation, and to provide international methodological experience and reference for the development of high-quality PROM psychometric attribute verification in China.
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.
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 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.
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 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.
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.
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 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.
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.