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.
ObjectiveTo assess the reliability, effectiveness, and the safety of full endoscopic transforaminal decompression (FETD) under local anesthesia guided by the classification of lateral region of the lumbar spinal canal (CLLSC) in treating lumbar spinal stenosis (LSS) in geriatric patients.MethodsThe clinical data of 63 geriatric patients with LSS met the inclusion criteria underwent FETD surgery between June 2015 and July 2017 were retrospectively analyzed. There were 37 males and 26 females, with a median age of 76 years [interquartile range (IQR), 73-80 years], and a median symptomatic duration of 55 months (IQR, 16-120 months). There were 17 cases of grade B and 46 cases of grade C based on the Schizas morphological grading system. CLLSC was used for imaging evaluation for the stenotic condition, and intra-class correlation coefficients (ICC) were used to test intra-observer and inter-observer reliability of CLLSC. The stenotic condition of patients was re-evaluated by the surgeon after operation, and the results were compared with the findings of preoperative CLLSC. The visual analogue scale (VAS) score for low back pain and leg pain recorded before operation, and at 1 day, 3 months, and 6 months after operation, and last follow-up were used to assess the pain relieving; the functional improvement was evaluate by Oswestry disability index (ODI); the modified Macnab criteria were used to self-evaluate the surgical satisfaction.ResultsThe operation were successfully performed for all patients, with a median operation time of 75 minutes (IQR, 65-85 minutes), postoperative hospitalization stay of 48 hours (IQR, 48-72 hours), and the time to ambulation after operation of 24 hours (IQR, 24-24 hours). Sixty-three patients were followed-up and with a median follow-up time of 18 months (IQR, 13-20 months). Based on preoperative CLLSC classification, there were 72 stenotic zones, distributed 16 in zone 1, 6 in zone 2, 3 in zone 3, 2 in zone 4, 7 in zone 5, 34 in zones 1+2, 2 in zones 3+4, and 2 in zones 4+5. Perioperative complications occurred in 4 cases (6.3%), including 2 cases of intraoperative dural sac tear, 1 of preoperative numbness symptom aggravation, and 1 of postoperative urinary retention. VAS score of leg pain and ODI score at each time point after operation were significantly improved compared with those before operation (P<0.05). VAS scores of low back pain showed no significant difference between pre- and post-operation (P>0.05). At last follow-up, based on the modified Macnab criteria, 19 cases were excellent, 37 were good, 6 were fair, and 1 was poor, and the excellent and good rate was 88.9%. The reliability analysis showed that CLLSC had substantial intra-observer reliability in the geriatric population, with an average ICC of 0.78. There was also a substantial inter-observer reliability, with an average ICC of 0.73. While comparing the preoperative CLLSC results with the postoperative CLLSC results, 53 patients (73.6%) were in full agreement, 15 patients (20.8%) were in partial agreement, and 4 patients (5.6%) were not.ConclusionCLLSC has high reliability in the diagnosis of LSS in the geriatric patients. Combined FETD with CLLSC, accurate diagnosis, and minimal invasion can be performed to achieve safe and effective result.
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.
Objective To evaluate the reliability and validity of the Chinese version of the Amsterdam Preoperative Anxiety and Information Scale (APAIS) in preoperative anxiety in patients with local anesthesia. Methods From May to December 2020, a convenient sampling method was used to conduct an APAIS questionnaire survey on patients undergoing percutaneous renal biopsy in the Department of Nephrology, West China Hospital, Sichuan University, and the reliability and validity of the scale were analyzed. ResultsA total of 460 questionnaires were distributed and 444 valid questionnaires were returned, with a valid response rate of 96.5%. The Cronbach α of APAIS was 0.896, the Guttman split-half reliability was 0.811, and the content validity index was 0.891. The model fit was 12.122 for the chi-square fit index/degree of freedom, 0.916 for the goodness-of-fit index, 0.902 for the value-added fit index, 0.079 for the root mean square error of approximation, and 0.946 for the comparative fit index. The APAIS anxiety subscale score was positively correlated with the 7-item Generalized Anxiety Disorder Scale score (r=0.518, P<0.001). Conclusion The APAIS has good reliability and validity for evaluating the level of preoperative anxiety in patients with local anesthesia, but the application of the scale in other conditions requires further testing.
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.
Meta-analysis has become a common approach to summarize genetic association with the tremendous amount of published epidemiological evidence. Assessing the credibility of meta-analysis evidence on genetic association is a rapidly growing challenge. This paper illuminates how to assess the credibility of meta-analysis evidence by using Venice criteria. A semi-quantitative index assigns three levels for the amount of evidence, replication and protection from bias. At the end, three considerations are merged into a grading scheme, which generates three composite assessments: weak, moderate or strong. Credibility assessment is necessary to estimate whether a true genetic association exists. Such method provides indication for further study and is of clinical importance.
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.