Objectives To explore the quality of the reporting of randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) for chronic fatigue syndrome (CFS).Methods We searched the Cochrane Central Register of Controlled Clinical Trials (CENTRAL) (The Cochrane Library, Issue 4, 2006), PubMed, EMbase, the Chinese Biomedical Database (CBMdisc), VIP Information, and China National Knowledge Infrastructure (CNKI) (from establishment to February 2007). We also checked the reference lists of included studies. The quality of the reporting of RCTs was assessed using the 22-item checklist of the CONSORT Statement and other self-established criteria. Results Thirty-eight RCTs were included. The word “randomization” was not present in any of the trials, and only 17 reports used a structured abstract. All trials did not report the scientific background and the rational for the trial, the estimation of the necessary sample size, the methods of allocation concealment and blinding, participant flow chart, ITT analysis, and ancillary analyses. Some authors misunderstood the diagnostic criteria and inclusion criteria, some selected inappropriate control interventions, and some did not clearly describe their statistical methods or used incorrect methods. All 38 trials reported positive outcomes, few reported adverse effects. No report included a general interpretation of the new trial’s results in the context of current evidence in their discussion section, and none mentioned the limitations of the study, the clinical and research implications or the external validity of the trial findings. Conclusion The overall reporting quality of RCTs of TCM for CFS is poor. Defects are found in each section of the reports. Researchers and journal editors should learn and use the principles and methods of evidence-based medicine—especially the use of a transparent prospective clinical trial register and the CONSORT Statement—to improve the design, conduct and report TCM trials.
Objective To access and identify risk factors related to death and injuries in earthquakes. Method We searched The Cochrane Library, SCI, PubMed, CBM and CNKI from establishment to June 2008 to identify cohort, case-control and cross-sectional studies involving risk factors related to death and injuries in earthquakes. The methodological quality of included cohort and case-controlled studies were assessed, and the potential risk factors of earthquake related death and injuries were systematically enumerated. Results Two cohort, 2 case-control and 4 cross-sectional studies were included. Some included studies might be associated with selection bias. Risk factors for earthquake death and injuries included age, gender, mental disease, physical disabled, socioeconomics status, type/ age/ height/ collapse of building, motor vehicle driver and geographical location when the earthquake occurred. Conclusions Death and injuries in earthquakes may be attributed to 3 categories: demographic characteristics, building features, and seismic/ geographical/ location factors. However, the conclusion of this review and its implications may be limited by the potential selection bias of included studies and the regional characteristics of the included populations. Original studies from Chinese seismic areas are especially needed.
This article conducts a mid-term evaluation of the implementation effect of the “West China-Chenghua Urban Area Medical Service Alliance” from 2016 to 2019 based on structure-process-outcome model. The structure of the alliance included five organizational sections, including the leadership group, West China departments, grassroots organizations, information platforms, and residents and health fan teams, aiming to provide integrated, homogeneous, and accessible medical services centered on residents’ health. The process of the alliance mainly included the joint reforms led by the “combination of government and hospital” and the management mechanism of “politics-people-medicine-network” four links. Alliance performance: in terms of grassroots services, the number of diagnoses and treatments increased, the number of diseases received increased, and the homogenization of test was initially achieved; in terms of grassroots training, several high-quality community doctors were trained, and the number of talents introduced increased; in terms of grassroots scientific research, 3 large-scale scientific research projects were undertaken and 4 articles were published in national-level publications; in terms of grass-roots awards, 5 honorary titles at national, provincial, and municipal levels were gained, and award-winning “zero” breakthrough in national skill competitions and academic conferences was achieved; in terms of alliance satisfaction, the employees in primary medical institutions and West China Hospital of Sichuan University and the residents in Chenghua District were all had high degree of satisfaction. The alliance has achieved innovation in management and services, and the employees and residents are highly satisfied, which is conducive to promoting the realization of the homogeneity of regional medical service capabilities. However, the salary system and capacity improvement of grassroots medical staff should be further explored.
Rational drug use is a global concern. As one of the highest risk groups for drug use, children's rational drug use has always been concerned. Based on the previous research results of the research group, we developed evaluation indicator systems for assessing rational drug use to treat community-acquired pneumonia and primary nephrotic syndrome in children and proton pump inhibitors in pediatric intensive care units and finished empirical research. This study further summarizes and expounds the construction ideas of rational drug use evaluation indicators for children based on diseases or drugs, and provides a reference for constructing children's rational drug use evaluation indicators.
ObjectiveTo systematically review the research on pediatric treatment satisfaction of medication (TS-M). MethodsThe PubMed, Embase, Cochrane Library, CBM, WanFang Data, VIP, CNKI databases and medical scale websites were electronically searched to collect studies on pediatric TS-M from inception to November 2022. Two reviewers independently screened literature, and extracted data. Using descriptive analysis, we comprehensively reviewed the TS-M assessment tool selected for the studies of children. We evaluated the methodological quality and measurement properties of existing TS-M scales for children using the Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) assessment criteria. ResultsA total of 157 studies were included, including 150 pediatric studies using TS-M evaluation tools and 7 studies on the development and validation of TS-M scales for children, covering 7 specific TS-M scales for children. Our review revealed that 67.3% of the pediatric studies used unvalidated self-administered TS-M questionnaires or interviews, 24.7% used adult TS-M scales, and only 6.0% used two pediatric-specific TS-M scales. The results of the quality assessment indicated that the development quality of existing TS-M pediatric scales was considered "doubtful" or "inadequate", and the internal consistency was "sufficient" but the structural validity was probably "uncertain". High-quality research on the content validity, test-retest reliability and construct validity of the pediatric TS-M scale was still lacking. ConclusionCurrently, the use of TS-M evaluation tools in pediatric studies has irrationalities: over 90% of pediatric studies use self-made questionnaires or adult scales to evaluate children's TS-M; and the existing pediatric TS-M scales globally have narrow applications, questionable development quality, and lack some measurement performance studies. Pediatric TS-M scales with a wide range of applications are lacking.
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.
Objective To analyze and compare the urban-rural difference of health resource allocation of maternal and child health institutions in Sichuan province. MethodsGini coefficient and agglomeration degree was used to analyze the equity of health resource allocation of maternal and child health institutions in Sichuan province. ResultsThe number of maternal and child health institutions per 10 000 population in rural areas was higher than that in urban areas, while the hospital beds and health workers per 10 000 population was lower. In terms of population-based Gini coefficient, the value of three type of health resources of maternal and child health institutions in Sichuan Province were lower than 0.4, indicating a good equity, however, the value of institutions and health workers in urban areas were lower than those in rural areas, the value of hospital beds were higher than those in rural areas. In terms of the difference between HRAD and PAD, there were great differences in the population-based accessibility of health resources of maternal and child health institutions in Sichuan province, relative excess and relative deficiency coexisted in different city (state). Moreover, there were differences in population-based accessibility to health resources of maternal and child health institutions between urban and rural areas in each city (state). ConclusionThere are obvious urban-rural and regional differences in health resources allocation of maternal and child health institutions in Sichuan province. Social factors such as population, geographical area and service radius should be comprehensively considered according to the real needs in the planning of rational health resources allocation of maternal and child health institutions.
ObjectiveTo investigate the development, production and use of children’s drugs in Sichuan Province, analyze the problems existing in these links, and provide suggestions for ensuring that children’s needs for drugs are met. MethodsThe self-filling electronic questionnaire was used to investigate the production, procurement and use of children’s drugs in 14 pharmaceutical companies producing children’s drugs and 20 general hospitals with pediatric departments or children’s hospitals in Sichuan province. ResultsThe 14 surveyed pharmaceutical companies reported that 116 children’s drugs were being developed or produced (75 first-class children’s drugs with exact medication information for children, 41 second-class children’s drugs only noted as children's discretionary reduction or use according to clinician’s instructions), out of which 109 (93.97%) drugs had been approved for marketing, 21 (18.10%) were national essential medicines and 76 (65.52%) were covered by national basic medical insurance. The dosage forms of first-class children's drugs were mainly tablets (28, 37.34%) and granules (19, 25.34%), while oral solution (3, 4.00%), syrup (5, 6.67%) and other dosage forms suitable for children were less. According to the surveyed results on the use of children's drugs in hospitals, there were 57 children’s drugs whose minimum use units needed to be manually divided into smaller ones on average in each hospital, and it was the most common operation pattern that pharmacists informed nurses, patients or patients’ family members of the dose splitting methods and then splitting drugs’ minimum use units by themselves. ConclusionThere is a great demand for splitting minimum use units of drugs whose strength is too big for children in medical institutions, and some children’s drugs need to be developed and further modified to meet the clinical children’s drug needs. We should further increase investments and policy supports for the children’s drugs, promote children’s clinical trials, and encourage the research and development of children’s drugs.
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.