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.
ObjectiveBy establishing a set of evaluation system for thoracoscopic clinical function and applicability, to evaluate and compare the advantages and disadvantages of different brands of thoracoscopes, and to provide some suggestions for the innovation and upgrade of thoracoscopes, especially for the domestic thoracoscopes.MethodsThe project coordination team initially formulated the evaluation index system for the clinical function and applicability of thoracoscope by querying literature and brainstorming. The Delphi expert consultation method was used to distribute questionnaires to the selected experts. Experts provided scores which were based on the importance of each indicator, and clarified the basis of their judgment and the familiarity with the evaluation indicators. After two rounds of screening by Delphi method, a thoracoscopic clinical function and applicability satisfactory questionnaire was formed. The appropriate sample for pre-investigation was selected, and the reliability and validity were tested. The index composition was adjusted based on the results of the test to form a final evaluation scale.ResultsThe project coordination team initially formulated 24 thoracoscope-related evaluation indicators. After two rounds of experts consultation, the item "brightness adjustment" was deleted without any additional entries. The positive coefficients of the experts in the first round and the second round were 100.0% and 80.0%, respectively. The two rounds of authoritative coefficients were 0.86 and 0.90, and the coordination coefficients were 0.272 (P<0.001) and 0.523 (P<0.001), respectively. A total of 140 questionnaires were issued in this pre-investigation. The recovery rate was 100.0% and the effective rate was 90.0%. The Cronbach's α value of the scale was 0.936, and the Spearman-Brown split-half reliability coefficient was 0.972. The factor analysis finally extracted 3 common factors. The total variance of the cumulative interpretation was 70.9%. The three common factors were named "operation related", "image related" and "device related".ConclusionThe evaluation index system developed in this study has good reliability and validity, and can be used as a tool to evaluate the clinical function and applicability of thoracoscopes.
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.
Evidence synthesis is the process of systematically gathering, analyzing, and integrating available research evidence. The quality of evidence synthesis depends on the quality of the original studies included. Validity assessment, also known as risk of bias assessment, is an essential method for assessing the quality of these original studies. Currently, there are numerous validity assessment tools available, but some of them lack a rigorous development process and evaluation. The application of inappropriate validity assessment tools to assessing the quality of the original studies during the evidence synthesis process may compromise the accuracy of study conclusions and mislead the clinical practice. To address this dilemma, the LATITUDES Network, a one-stop resource website for validity assessment tools, was established in September 2023, led by academics at the University of Bristol, U.K. This Network is dedicated to collecting, sorting and promoting validity assessment tools to improve the accuracy of original study validity assessments and increase the robustness and reliability of the results of evidence synthesis. This study introduces the background of the establishment of the LATITUDES Network, the included validity assessment tools, and the training resources for the use of validity assessment tools, in order to provide a reference for domestic scholars to learn more about the LATITUDES Network, to better use the appropriate validity assessment tools to conduct study quality assessments, and to provide references for the development of validity assessment tools.
Objective To investigate the validity of estimating American Spinal Injury Association Impairment Scale (AIS) grade with a bowel-routine based self-administered questionnaire for assessment of sacral sparing after spinal cord injury (SCI).Methods The 5-item SCI sacral sparing self-report questionnaire was administrated to SCI inpatients from August 2014 to July 2016, followed by an standardized digital rectal examination. Question 1 (perceiving the tissue), Question 2 (identifying the water temperature as warm or cold), Question 3 (perceiving the inserted finger), and Question 4 (perceiving the inserted enema tube) tested the sensory sacral sparing, and Question 5 (holding the enema for more than 1 min) evaluated the voluntary anal sphincter contraction. Based on the answers from each participant, the sensory and motor sacral sparing was implied, and an estimated AIS grade (AIS A, AIS B, or AIS C/D) was recorded. Agreement of the estimated AIS grade and the actual AIS grade according to the physical examination was analyzed. Sensitivity, specificity, and Youden’s index of the questionnaire for estimating completeness of injury were calculated.ResultsA total of 102 SCI patients were enrolled. The general agreement of estimated and actual AIS grades was good (κ=0.681, P<0.001). For the estimation of a complete injury, both the sensitivity (87.10%) and the specificity (100.00%) of this questionnaire were high, with a Youden’s index of 0.87. For the estimation of a motor complete injury, the sensitivity increased (92.00%) while the specificity decreased slightly (75.00%), with a Youden’s index of 0.67.ConclusionsThe validity of this self-report questionnaire for estimation of AIS grade is good. In some situations, it could be considered as an alternative tool for the estimation of sacral sparing as well as the AIS grades within SCI individuals, especially when repeated anorectal examinations are not feasible.
ObjectiveTo evaluate the reliability and validity of the instrument of clinical applicability of guidelines (version 2.0). MethodsThe experts of domestic medical institutions were investigated by questionnaire, and the instrument of clinical applicability of guidelines (version 2.0) were evaluated the guidelines for the diagnosis and treatment of tinea mantis and tinea pedis (revised edition 2017) and the guidelines for the diagnosis and treatment of cerebral hemorrhage in China (2019). Using Cronbach's α coefficient and Spearman-Brown coefficient to evaluate the inherent reliability and split-half reliability. The content validity was evaluated by calculating the content validity index of the item level and the adjusted Kappa value. The correlation coefficient between each item and the dimension and the hypothesis test were used to evaluate the convergent and discriminant validity. The structural validity was evaluated by using structural equation model to evaluate the structural validity of the tool. ResultsThe Cronbach's α coefficient and Spearman-Brown coefficient of the instrument of clinical applicability of guidelines (version 2.0) were both greater than 0.7, the content validity index (S-CVI/Ave) were more than 0.8, the success rates of convergent were 100%, and the success rates of discriminant validity calibration were 100% and 96%. In the second-order confirmatory factor analysis model, the χ2/ df were less than 3, the fitting index (CFI), the goodness of fit index (GFI) and the adjustment goodness of fit index (AGFI) were all greater than 0.9. The root mean square residual (RMR) were all less than 0.05, and approximate error root mean square (RMSEA) were less than 0.09. The P value of RESEA hypothesis test were more than 0.05. ConclusionThe instrument of clinical applicability of guidelines (version 2.0) has good reliability and validity, which can be further verified in practical application in the future.
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.
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 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.