Objective To compare the costs of Danmu extract syrup and Xiaoer Chiqiao Qingre granules for the treatment of acute upper respiratory tract infection (AURI) in children. Methods We conducted this prospective cohort study from July 2018 to June 2020. Children with AURI in the pediatric outpatient department and emergency department of West China Second Hospital were enrolled, and were divided into two groups: Danmu extract syrup group (Danmu group) and Xiaoer Chiqiao Qingre granule group (Chiqiao group) according to the treatment. The pharmacoeconomic evaluation took the medical and health system as the research perspective and considered direct medical costs, including registration fees, drug fees, inspection fees, testing fees, and treatment fees. A cost-effectiveness analysis or a cost minimization analysis was adopted according to the results of efficacy between the two groups. Results We enrolled 1 036 children with AURI. After propensity score matching, 252 in the Danmu group and 253 in the Chiqiao group were included. There was no statistically significant difference in the symptom recovery time between the two groups. The cost minimization analysis showed that the total costs (median difference −21.55) and drug costs (median difference −7.24) of the Danmu group were significantly lower than those of the Chiqiao group (P<0.001). The results of the subgroup and sensitivity analyses were consistent with the primary analysis. Conclusion Danmu extract syrup is a cost-saving alternative compared with Chiqiao granules for AURI in children.
Health technology assessment is a systematic assessment of the nature and impact of health technology. It is a science that solves the problems of health intervention or health technology on society, economy, organization and ethics. Aiming at the current issues of availability, accessibility, affordability, rationality and safety in the field of medical devices, health technology assessment can systematically evaluate the characteristics, effects and impact of medical devices, and provide evidence-based basis for scientific decision-making. Starting from the current status and challenges of medical device management, this paper introduces the origin and development, basic scope, assessment process and main assessment content of health technology assessment, and introduces the application of health technology assessment in medical device management through case studies, so as to promote development of health technology assessment in the field of medical device management and make medical device management more scientific and standardized.
ObjectiveTo analyze the current status of children's clinical practice guidelines from 2010 to 2021, and to evaluate the quality of evidence-based guidelines for children. MethodsPubMed, EMbase, CNKI, WanFang Data, and VIP databases and relevant domestic and foreign guideline websites were searched to collect Chinese pediatric clinical guidelines from January 1st 2010 to September 13th 2021. Two reviewers independently screened literature, extracted data; 4 reviewers used AGREE Ⅱ to evaluate the quality of the included evidence-based guidelines. ResultsA total of 164 guidelines were included, which involved 65 evidence-based guidelines and 99 non-evidence-based guidelines, 113 western medicine guidelines and 51 traditional Chinese medicine guidelines. The majority of the diseases with high hospitalization burden were covered by those guidelines, including 35 guidelines for respiratory diseases, ranking first among all diseases. However, there was no guideline for pediatric cardiovascular disease in China. The average scores for 65 evidence-based guidelines in 6 individual domains were 65.2%, 49.6%, 59.3%, 68.5%, 23.9% and 83.6%. ConclusionsThe scores for applicability, stakeholder involvement, and rigor of development are low for Chinese guideline for children. There is a lack of pediatric clinical guidelines for circulatory disorders.
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 summarize the evaluation tools for the implementation effect of clinical practice guidelines (CPGs), to inform and support the evidence-based development of a general tool for the evaluation of implementation effect of CPGs. MethodsSeven biomedical literature databases, including PubMed, Embase and CNKI, and two academic websites, were searched from establishment to June 2022. Theoretical and empirical research on the evaluation tools of the implementation effect of CPGs were included. Two researchers independently screened literature and extracted data according to the inclusion and exclusion criteria. Based on the Implementation Science RE-AIM theoretical framework, an evaluation framework and a list of alternative items of the implementation effect of the CPGs were initially drawn up by thematic synthesis methods. ResultsA total of 208 articles were included, and 8 mature evaluation tools related to the implementation effect of guidelines were selected. Current research on the evaluation of the implementation effect of CPGs mainly focused on single diseases, with concern of the cognition, attitude and compliance of users to CPGs, and the process of the implementation of CPGs and factors affecting the implementation effect of CPGs. There were limitations such as a lack of evaluation on the terminal effect of the implementation of CPGs, the rare use of mature theoretical frameworks, the use of single evaluation perspectives, and inclusion of limited evaluation dimensions. The initial proposed evaluation framework contains a list of alternative items with 6 primary indicators, 12 secondary indicators and 41 tertiary indicators. ConclusionCurrently, there is a lack of a comprehensive, multi-perspective, mature theory based, general tool for the evaluation of implementation effect of CPGs. The framework and the list of alternative items for the evaluation of implementation effect of CPGs based on the implementation science RE-AIM theory can inform and support the development of a tool for the evaluation of implementation effect of CPGs.
ObjectiveTo systematically review the classification system for the causes of pediatric drug shortages in China, and classify the causes of pediatric drug shortages accurately, so as to provide references for the formulation of targeted strategies. MethodsFour databases including Embase, PubMed, CBM and CNKI were searched from inception to November 2023. Quantitative research, qualitative research and mixed-method research on the causes of pediatric drug shortages in China were included. Two researchers independently screened the literature and extracted data. Based on the theory of efficient market and effective government, and according to the life cycle of the drug supply chain, the fundamental causes of drug shortages were classified and summarized by thematic synthesis. ResultsFourteen articles were included. According to the four stages of the drug supply chain (research and development, production, circulation and use), a total of 19 categories of causes of the pediatric drug shortages were summarized, including 5 categories in the research and development stage, 4 categories in the production stage, 6 categories in the circulation stage, and 4 categories in the use stage. Based on the theory of efficient market and effective government, further analysis of the causes revealed that the identified reasons could be attributed to three major fundamental causes: market failure, government failure, and other causes. Among them, 6 categories were related to market failure, 7 categories were related to government failure, and 6 categories were classified as other causes. ConclusionBased on the theory of efficient market and effective government, this study established a classification system of fundamental causes of the pediatric drug shortages, and made policy suggestions accordingly. Subsequently, the classification system established in this study can be used as references to develop targeted strategies to solve the problem of pediatric drug shortages in the life cycle of drug supply chain from government and market perspectives.
ObjectiveTo systematically review the efficacy of pidotimod in children.MethodsPubMed, The Cochrane Library, EMbase, CNKI, CBM, VIP and WanFang Data databases were searched online to collect randomized controlled trials (RCTs) on pidotimod in children from inception to January, 2018. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies, then, meta-analysis was performed by using RevMan 5.3 software.ResultsA total of 310 RCTs involving 30 525 children were included. The results of meta-analysis showed that, compared with conventional therapy, conventional therapy combined with pidotimod could not improve the efficacy of children with respiratory infections (RR=1.78, 95%CI 0.99 to 3.20, P>0.05). However, pidotimod could significantly reduce the number of respiratory tract infection (MD=−2.79, 95%CI −3.12 to −2.46, P<0.05), shorten the time of respiratory tract infection (MD=−4.15, 95%CI −4.72 to −3.58, P<0.05), and the time of fever (MD=−1.47, 95%CI −1.77 to −1.17, P<0.05) in recurrent respiratory tract infection. Pidotimod could also reduce the time of fever (MD=−0.90, 95%CI −1.60 to −0.20, P<0.05) in children with mycoplasma pneumoniae pneumonia, the time of fever (MD=−1.51, 95%CI −1.91 to −1.11, P<0.05) in children with hand-foot-mouth disease, and reduce the incidence of anaphylactoid purpura followed up for 6 months (RR=0.42, 95%CI 0.30 to 0.61, P<0.05) in children with anaphylactoid purpura. However, there was no significant difference between two groups in the recurrence of asthma for 1 year follow-up (RR=0.80, 95%CI 0.60 to 1.06, P>0.05).ConclusionCurrent evidence shows that pidotimod may be effective for children with respiratory tract infection, asthma, hand-foot-mouth disease, could reduce disease relapse and relieve symptoms related to illness.
ObjectivesTo investigate the current status of the clinical applicability evaluation tools, and to provide some foundation for establishment of the clinical applicability evaluation index system.Methods7 databases, 6 guideline databases and 16 academic institutions and the administrative department of health website were systematically searched from inception to April 2019. Two reviewers independently screened literature, extracted data and then included the literature related to the applicability of clinical guidelines. The CPG clinical applicability evaluation index was initially prepared through the subject comprehensive method.ResultsA total of 19 articles were finally included. Among them, there were 4 evaluation tools for the clinical applicability of the guidelines, and 15 evaluation tools for the guideline clinical applicability evaluation items. Through combing and comparison, we found that these tools had differences in evaluators, evaluation fields and items.ConclusionsThe global guidelines for clinical applicability assessment tools have different kinds of problems, such as that the tools are not targeted, the indicators are not well-formed, and the methodological knowledge requirement of the evaluators is high. There is still a lack of guidelines for clinical applicability assessment tools from target users’ view.
ObjectivesTo establish statistical analysis and result reporting model for evaluation of the applicability of the clinical guidelines. We conducted an empirical study for clinical guidelines for the prevention and treatment of type 2 diabetes in China.MethodsA cross-sectional survey was conducted to select 6 to 8 doctors in geriatric, endocrinology, nephrology or related departments from medical institutions. The questionnaire was filled by doctors at a conference and electronic questionnaires were sent to those who did not attend the conference. Descriptive analysis was carried out for characteristics of evaluators, scores of each dimension, access to guidelines and factors affecting implementation. The Kruskal-Wallis rank-sum test and Nemenyi test were used for multi-group comparison and pairwise comparison. Multiple linear regressions with the stepwise strategy were used to screen out the association factors.ResultsA total of 725 questionnaires were collected in this survey. There were 722 valid questionnaires with an active recovery rate of 99.6%. The results showed the accessibility score was lowest and the acceptability score was highest. The results of multi-group comparison and multiple linear regression analysis showed that familiarity with the guidelines was the influencing factor of each score (P<0.05). The guidelines were primarily obtained from academic conferences (52.1%), WeChat (45.4%), and biomedical literature databases (43.5%). Among the evaluators, 44 (41.9%) believed that there were implementation obstacles in the guidelines, among which 136 (18.8%), 134 (18.5%) and 133 (18.4%) believed that implementation obstacles were medical personnel factor, patient factor and environmental factor.ConclusionsIn this study, a data analysis and result report model for the assessment of the applicability of the guidelines is established to provide evidence for the development/revision of the guidelines.