Objective To evaluate the cost-effectiveness of chemotherapy in children with newly diagnosed Hodgkin lymphoma at low-, intermediate-, and high-risk. Methods From the perspective of health system, a decision-tree model was designed for cost-effectiveness analysis. The chemotherapy regimens of low-risk group included OEPA (vincristine, etoposide, prednisone, doxorubicin), AV-PC (doxorubicin, vincristine, prednisone, cyclophosphamide), and ABVD (doxorubicin, bleomycin, vincristine, dacarbazine); intermediate-risk group included OEPA, ABVE-PC (doxorubicin, bleomycin, vincristine, etoposide, prednisone, cyclophosphamide) and ABVD; high-risk group included OEPA, ABVE-PC, ABVD and BEACOPP (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, prednisone). The effectiveness and cost parameters were derived from the event-free survival rate reported in the literature, the drug linked reference price in Sichuan province, and treatment price of medical institutions. Univariate and probabilistic sensitivity analysis were performed to explore the impact of uncertainty. Results In the low-risk group, compared with AV-PC, the incremental cost-effectiveness ratios (ICER) of OEPA and ABVD were 80 700 yuan and 108 799 yuan, respectively. In the intermediate-risk group, compared with OEPA, the ICER of ABVE-PC and ABVD were −17 737 yuan and −4 701 yuan respectively. In the high-risk group, compared with ABVE-PC, the ICER of OEPA, ABVD and BEACOPP were 149 262, 472 090 and 64 652 yuan, respectively. Univariate sensitivity analysis showed that in low-risk group, the most influential factors were cost of OEPA and cost of ABVD; in moderate-risk group were cost of ABVE-PC and cost of OEPA; in the high-risk group were cost of OEPA, cost of ABVD, and cost of BEACOPP, respectively. The results of probabilistic sensitivity analysis are basically consistent with those of the main analysis. Conclusion If China's per capita gross domestic product in 2023 (89 358 yuan) was used as the willingness-to-pay (WTP) threshold, OEPA in the low-risk group, OEPA in the intermediate-risk group and BEACOPP in the high-risk group are cost-effective.
ObjectivePublic health information collection is critical in improving the capacity of basic public health services. Our study took the "Wei Jian E Tong" APP as an example to evaluate the willingness and influencing factors of rural public health service personnel to continue using such APPs.MethodsWe applied exploratory sequential design in mixed-method research and chose Renshou county in Sichuan province as the representative region. Firstly, we used the personal in-depth interview to initially explore the status quo, applicability, continued willingness to use APP and other issues. Secondly, we used unified theory of acceptance and use of technology (UTAUT) and expectation confirmation theory (ECT) to construct a hypothetical model of influencing factors of user satisfaction. We then designed a structured questionnaire covering 7 measurement dimensions to survey all users of the APP at the survey site. Finally, we used structural equation model to verify the research hypothesis.ResultsA total of 21 individuals were interviewed in this survey, including leaders of township health centers, public health doctors, and rural doctors. Qualitative results showed the major defects were insufficient funds and policy support in the promotion and application, additionally lack of software functionalities and system incompatibility. A total of 593 valid questionnaires were collected from the quantitative survey on the satisfaction of township doctors and village doctors. Structural equation model results showed that seven direct hypotheses were established, of which compatibility had the largest effect value user satisfaction with a total effect value of 0.617, followed by facilitating condition (r=0.211), performance expectancy (r=0.137), effort expectancy (r=0.091) and social influence (r=0.068).ConclusionsTo promote the application of information collection apps in primary public health services and improve user satisfaction, the focus should be on solving software incompatibility and create interconnection among all levels of medical systems. At the same time, it is necessary to solve funding problems as a whole, optimize software functions, improve the performance evaluation system, and improve software training and promotion.
ObjectiveTo systematically review the safety of hand disinfectants. MethodsPubMed, EMbase, The Cochrane Library, INAHTA, WanFang Data, CNKI and VIP databases were electronically searched to collect studies on the safety of hand disinfectants from inception to February 1st, 2021. Two reviewers independently screened the literature, extracted data and assessed the risk of bias of the included studies; then, a systematic review was conducted. ResultsA total of 50 studies were included. The reported adverse events were eye and nasal mucosal irritation, hand adverse events with skin itching, rash, erythema, edema and so on. A total of 29 brands such as 3M Avagard and 26 ingredients such as ethanol were reported to be related to the above adverse events. Hand disinfectants containing glycerin, silicone oil, vitamin B, plant extracts and other emollients could reduce the incidence of adverse events. ConclusionCurrent evidence shows that hand disinfectants containing emollients and free from ethanol, chlorhexidine and other ingredients are related to fewer adverse events. Due to the limited quality and quantity of the included studies, more high-quality studies are needed to verify the above conclusion.
ObjectiveTo systematically review the research status of therapeutic drug monitoring (TDM) for traditional Chinese medicine. MethodsPubMed, EMbase, The Cochrane Library, CNKI, WanFang Data, CBM, VIP databases, official websites of governments and societies associated with TDM were electronically searched to collect studies on TDM for traditional Chinese medicine from inception to January, 2022. Two reviewers independently screened literature and extracted data. Then, a qualitative systematic review was conducted. ResultsA total of 13 studies were included, all of which came from China and were small sample size studies. The studied population consisted mainly of healthy volunteers (85%), followed by patients of coronary artery disease with blood stasis pattern (31%), patients of rheumatoid arthritis (8%), and patients of acquired immune deficiency syndrome (8%). There were two types of medicine, including proprietary Chinese medicine (69%) and Chinese herbal pieces (31%). The research topics were all theoretical research of TDM, mainly concentration detection methods (77%), followed by influence factors of blood drug concentration (15%), the selection of specimen (15%), the selection of monitoring object (8%) and the concentration reference range (8%). There was no clinical practice study on TDM of traditional Chinese medicine. ConclusionTDM of traditional Chinese medicine is still in the exploratory stage in China. Published studies are mainly on the theoretical research of TDM, and no relevant studies is on clinical practice of TDM of traditional Chinese medicine.
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.
Objective To update and form an instrument for evaluating clinical applicability of guidelines (version 1.0). Methods We updated the systematic review of global guideline clinical applicability evaluation instruments to form the initial item list and carried out Delphi expert consultation to establish the instrument for evaluating clinical applicability of guidelines (version 2.0). Results The general structure of version 2.0 was consistent with that of version 1.0, which included 12 evaluation items belonging to five domains covering accessibility, readability, acceptability, feasibility, and an overall evaluation. Moreover, some new items were added in version 2.0, such as "The guideline does not provide supporting tools or resources and the operation is poor", "After the guideline implementation, the expected effects of diagnosis and treatment do not be achieved", " Medical staff in your workplace believe that the guideline is not necessary because they have sufficient medical experience, etc.", "Lack of authority of the organizations and personnel that developed the guideline" and "Medical staff in your workplace are reluctant to change the original medical practice". Conclusion This study updated and formed an instrument for evaluating clinical applicability of guidelines (version 2.0), which is able to better assess the applicability of new clinical guidelines and greatly promote more appropriate guidelines into practice.
ObjectiveTo describe the current status of the evaluation index for the performance of diagnostic reagents compared with gold standards in systematic reviews and develop the list of evaluation indexes. MethodsPubMed, Embase (OVID), Cochrane Library (OVID), CBM, WanFang Data and CNKI databases were searched for systematic reviews about the performance of diagnostic reagents compared with gold standards from inception to 28th April, 2023. Two reviewers independently screened literature and extracted data. The frequency and ratio were used to describe the current status, while the qualitative synthesis was used to develop the list. ResultsA total of 133 systematic reviews were included. Sensitivity (133/133, 100.0%), specificity (131/133, 98.5%) and AUC (80/133, 60.2%) were used more frequently than 50%. Q index (6/133, 4.5%), false positive rate (3/133, 2.3%), Kappa value (2/133, 1.5%), false negative rate (1/133, 5%) and Youden's index were used less frequently than 5%. In order to evaluate the performance of diagnostic reagents compared with gold standards in systematic reviews comprehensively, a total of 14 index related to validity and predictability could be considered. ConclusionThe evaluation index for the performance of diagnostic reagents in systematic reviews are inconsistent and limited, so there is an urgent need to develop standardized evaluation indicators based on expert consensus.
ObjectivesTo explore the construction method of prediction model of absolute risk for breast cancer and provide personalized breast cancer management strategies based on the results.MethodsA case-control design was conducted with 2 747 individuals diagnosed as primary breast cancer by pathology in West China Hospital of Sichuan University from 2000 to 2017 and 6 307 healthy controls from Breast Cancer Screening Cohort in Sichuan Women and Children Center and Chengdu Shuangliu District Maternal and Child Health Hospital. Standardized questionnaires and information management systems in hospital were used to collect information. Decision trees, logistic regression, the formula in Gail model and registration data in China were used to estimate the probability of 5-year risk of breast cancer. Eventually a ROC (receiver operating characteristics) curve was drawn to identify optimal cut-off value, and the power was evaluated.ResultsThe decision tree exported 4 variables, which were urban or rural sources, number of live birth, age and age at menarche. The median 5-year risk and interquartile range of the controls was 0.027% and 0.137%, while the median 5-year risk and interquartile range of the cases was 0.219% and 0.256%. The ROC curve showed the cut-off value was 0.100%. Through verification, the sensitivity was 0.79, the specificity was 0.73, the accuracy was 0.75, and the AUC (area under the curve) was 0.79.ConclusionsThe methods used in our study based on 9 054 female individuals in Sichuan province could be used to predict the 5-year risk for breast cancer. Predictor variables include urban or rural sources, number of live birth, age, and age at menarche. If the 5-year risk is more than 0.100%, the person will be judged as a high risk individual.
Objective To evaluate the clinical applicability of clinical practice guidelines in China in the past 5 years, and to provide suggestions for better development and implementation of guidelines. Methods A cross-sectional study was conducted. A total of 61 guidelines issued by the Chinese Medical Association and the Chinese Medical Doctor Association from 2015 to 2020 were selected randomly based on CNKI database. Each guideline was evaluated by medical staff from three regions using the instrument for evaluating clinical applicability of guidelines (version 2.0). Quantitative data were described by mean, standard deviation, median and interquartile range, while qualitative data were described by frequency and composition ratio. Results A total of 6 904 valid questionnaires were collected from 119 medical institutions in 26 provinces of China. The results showed that the standardized scores ranged from 54.4% to 72.7% (median 64.3%) for accessibility, from 66.1% to 83.3% (median 74.9%) for readability, from 53.7% to 94.7% (median 86.0%) for acceptability, and ranged from 61.4% to 81.0% (median 72.5%) for feasibility. Approximately 4.3% of the medical staff considered that there were obstacles to implement the guidelines, including environmental factors (32.1%), medical staff factors (26.5%), guidelines factors (22.5%), and patients or family factors (18.9%). Conclusion The overall clinical applicability of the guidelines selected in this study is satisfactory. However, it is necessary to improve the accessibility of clinical guidelines. In addition, to improve the clinical applicability, it is suggested that medical staff should be trained and provided with supporting resources.
The instrument for evaluating clinical applicability of guidelines (version 2.0) is designed to evaluate the clinical applicability of guidelines quantitatively. It is helpful to select guidelines with high clinical applicability and provide suggestions for revision. The evaluators are consistent with the target users of guidelines. The instrument consists of basic information, evaluation items and scoring scheme. The evaluation items are related to accessibility, readability, acceptability, feasibility and overall evaluation. Therefore, this article provides a detailed interpretation of the instrument and references for future users.