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 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.
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 evaluate the reliability and validity of Guideline Implementation Success Assessment Tool (A-GIST). MethodsWith the guideline for the prevention and treatment of type 2 diabetes mellitus in China (2020 edition) as the target guideline, health care providers and patients from different hospitals across the country were investigated by questionnaire using A-GIST. Spearman-Brown coefficient and Cronbach's α coefficient were used to evaluate the split-half reliability and internal consistency reliability, while the structural validity, convergent validity and discriminant validity were investigated by confirmatory factor analysis based on structural equation. ResultsThe internal consistency reliability and split half reliability coefficients of the whole tool and each dimension ranged from 0.650 to 0.986. The scale-level content validity index (S-CVI/Ave) of content validity was 0.846. Confirmatory factor analysis showed that, the χ2/df of two sections of the tool were 8.695 and 6.123, respectively. The root mean square residual (RMR), the standard root mean square residual (SRMR) and the root mean square error of approximation (RMSEA) were under or almost under the threshold. Besides, the goodness-of-fit index (GFI) of them were 0.901 and 0.822, the adjusted goodness-of-fit index (AGFI) were 0.836 and 0.787, and the parsimonious normed fit index (PNFI) were 0.545 and 0.788, respectively. ConclusionGuideline Implementation Success Assessment Tool (A-GIST) was proved to be valid and reliable, and it shows that it is necessary to optimize the items under the dimensions of maintenance and evaluation of diagnosis and treatment effect in the future.