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.
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 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 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.
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.
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.
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.
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.
The COSMIN community updated the COSMIN-RoB checklist on reliability and measurement error in 2021. The updated checklist can be applied to the assessment of all types of outcome measurement studies, including clinician-reported outcome measures (ClinPOMs), performance-basd outcome measurement instruments (PerFOMs), and laboratory values. In order to help readers better understand and apply the updated COSMIN-RoB checklist and provide methodological references for conducting systematic reviews of ClinPOMs, PerFOMs and laboratory values, this paper aimed to interpret the updated COSMIN-RoB checklist on reliability and measurement error studies.