This article introduces a dynamical stratified blocked randomized algorithm when the static stratified blocked randomized algorithm is not suitable to resolve the problem caused by uncertain stratified factors and levels during calculation of the sample size at the stage of clinical trial design. Prior to the start of the clinical trial, a list of random numbers is created by blocked randomized algorithm. During field implementation, a block of random numbers is dynamically allocated to a stratify level. Thereafter, a subject is randomized into different groups in that block. The study of Chinese medicine for gastric cancer anemia and blood hypercoagulability is used as an example to illustrate how to design and implement dynamic stratified block randomized algorithm. The results show that the dynamic stratified block randomized algorithm is more flexible and adaptable than the static stratified blocked randomized algorithm. However, its application is more complex and requires higher standards in clinical trials.
This review describes the concept of artificial intelligence, introduces the working mechanism and the main structure of medical expert system, as well as the development history of medical expert system at home and abroad and its applications in the medical field. The concept of machine learning, commonly used algorithms and its clinical applications in medical diagnosis are briefly described. It mainly introduces the application of artificial intelligence in neurology. The advantages and disadvantages of artificial intelligence system in medical field are analyzed. Finally, the future of artificial intelligence in the medical field is forecasted.
ObjectiveTo evaluate the developing methodologies of Essential Medicines Lists for Children (EMLcs) in global, in order to provide reference in developing EMLc of China. MethodsWe searched ProQuest, ScienceDirect, SpringerLink and MEDLINE databases, World Health Organization (WHO) official website, and 67 websites of National Ministry of Health and Drug Administration Section, to collect literature about selection methodology of children and/or adult essential medicines list (EML). A descriptive analysis was conducted. ResultsA total of fourteen literatures were included. Of which, 6 were about the essential medicines selection methodology in children, and the other 8 were about the essential medicines selection methodology in adult. The WHO had established independent EMLc selection committee. Paediatricians were involved in the selection of EMLc in the WHO and India. There was no selection criteria and process for EMLc globally. The WHO, India, and South Africa selected their EMLcs referring to the WHO EML selection criteria. The WHO and South Africa had their own updating time, period and process for EMLc. The WHO EMLc was updated per 2 years, which in high frequency and conducts in rigorous process. However, the EMLc of India had not been updated yet. ConclusionIt is suggested that China could build a national EMLc selection committee involving paediatricians and evidence-based medicine experts etc. in referring to the framework of the WHO Child Health Working Group. The EMLc selection criteria and process of China could be established referring to the one of the WHO, based on the disease burden, drug accessibility and medical insurance of children of China. The EMLc of China should be simultaneously updated with the adult EML of China.
Objective To learn the current situation of traditional Chinese medicine (TCM) systematic reviews/meta-analyses published in Chinese journals. Methods All TCM systematic reviews/meta-analyses published from 1978 to July 31, 2009 were searched in the Chinese Biomedical Database (CBM). According to the inclusion and exclusion criteria, relevant information was extracted on the basis of research purpose. Meanwhile, publication year, journal name, author’s district, number of authors and their articles, types of diseases and interventions were took as the indexes, and then descriptive analysis was performed using SPSS 15.0 software. Results A total of 245 articles including 238 in Chinese and 7 in English were included. All of them were published in 117 different journals from 1998 to 2008, showing an accelerating growth trend of article number. In addition to only one article with first author from Germany, the first author of other 244 were from 24 domestic provinces (autonomous regions and municipalities); the number of authors ranged from 1 to 11; a total of 186 people had published articles as first author, and the number of their published articles ranged from 1 to 29. There were 16 types of diseases according to the International Classification of Diseases 10th Edition (ICD-10). Totally, 218 articles took drugs as interventions (including 106 listed drugs, 25 self-made prescriptions, 70 related to both listed drugs and self-made prescriptions, and 17 without reporting detailed interventions), accounting for 89%; and 27 articles were about non-drug interventions (including 26 about acupuncture and 1 about massage), accounting for 11%. Most (95.8%) of the articles about self-made prescriptions and listed drugs/self-made prescriptions adopted inappropriate pooled analyses. Conclusion Evidence-based medicine has been spread into the field of TCM, the number of TCM systematic reviews/meta-analyses shows an accelerated growth trend. The types of diseases discussed in the literature were almost the same as the diseases those could be effectively treated by TCM, but there existed imbalance in districts. In the future, systematic review/meta-analysis on drug intervention should aim at Chinese patent medicines and single medicines rather than self-made prescriptions, and should pay more attention to advantageous drugs and advantageous treatments of diseases. Moreover, importance should be also attached to clinical heterogeneity controlling when using acupuncture as a non-drug intervention.
ObjectivesTo investigate sources of evidence of the clinical pathways approved by the Chinese government.MethodsThe approved clinical pathways were obtained from the website of the National Health and Family Planning Commission. Two reviewers independently extracted the basic information, approval date, types of evidence of the clinical pathways and time of evidence. The variance analysis was performed for the diagnosis and treatment parts of clinical pathways and the LSD method was further used for comparison.ResultsThe main types of evidence were guidelines, textbooks, standard indicators and consensus views. Approximately 80% of the pathways cited clinical practice guidelines and 36% cited the textbooks. The median number of evidence for each clinical pathway was 2. Approximately 85% of the evidence could be obtained the time when the evidence published. The average time interval (between the time when the pathways released and the time when the evidence published) was 5.2 years. Specifically, textbooks constituted the largest proportion in all evidence that was over 15 years of time interval. In addition to the textbook comparison standard indicators, there were significant differences in time interval between guidelines or consensus and textbooks or standard indicators.Conclusions The evidence types selection is based on the concept of evidence-based medicine, yet the time span of the referred evidence is larger. Therefore, developing clinical pathways not only need to refer to the latest research evidence comprehensively and enhance transparency of clinical pathways, but also use evidence quality evaluation standards to evaluate and select the referred evidences.
Master protocol is a great transformation of clinical trials with complete research network, reasonable design and innovative statistical analysis methods. It is a highly efficient new model of clinical trials which could obtain more medical information with less clinical resources. Clinical researches in the field of oncology using master protocol have already made delightful achievements. This paper introduces the design of clinical trials on angina pectoris of coronary heart disease, myocardial infarction and heart failure for instance and discusses the application of master protocol to clinical researches of Traditional Chinese Medicine combined with the differentiation of syndromes and treatments. We expect to provide new ideas and methods for the design of master protocol on diseases with similary syndrome pattern series of Traditional Chinese Medicine.
Objective To investigate the methodological characteristics of observational studies on the correlation between drug exposure during pregnancy and birth defects. Methods The PubMed database was searched from January 1, 2020 to December 31, 2020 to identify observational studies investigating the correlation between drug use during pregnancy and birth defects. Literature screening and data extraction were conducted by two researchers and statistical analysis was performed using R 3.6.1 software. Results A total of 40 relevant articles were identified, of which 8 (20.0%) were published in the four major medical journals and their sub-journals, 21 (42.5%) were conducted in Europe and the United States, and 4 were conducted (10.0%) in China. Cohort studies (30, 75.0%) and case-control studies (10, 25%) were the most commonly used study designs. Sixteen studies (40.0%) did not specify how the databases were linked. Sixteen studies (40.0%) did not report a clear definition of exposure, while 17 studies (42.5%) defined exposure as prescribing a drug that could not be guaranteed to have been taken by the pregnant women, possibly resulting in misclassification bias. Six studies (15.0%) did not report the diagnostic criteria for birth defects and 18 studies (45.0%) did not report the types of birth defects. In addition, 33 studies (82.5%) did not control for confounding factors in the study design, while only 19 studies (47.5%) considered live birth bias. Conclusion Improvements are imperative in reporting and conducting observational studies on the correlation between drug use during pregnancy and birth defects. This includes the methods for linking data sources, definition of exposure and outcomes, and control of confounding factors. Methodological criteria are needed to improve the quality of these studies to provide higher quality evidence for policymakers and researchers.
Abstract: Objective To analyze the characteristics of pathogens isolated from patients with lung cancer after surgery, and provide instructions for the prevention and treatment of postoperative infection. Methods A retrospective investigation of the pathogenic microbiology data of 159 patients（142 males and 17 females with average age at 61.8±9.6 years) with lung cancer after surgery in West China Hospital from January 2009 to December 2011 was performed.We got the specimen from the patients by routine methods, identified the pathogens, and conducted drug susceptibility tests in vitro. Results The pathogens were mainly isolated from sputum of the patients （90.6%, 155/171）. Canidia albicans（25.7%, 44/171）, Klebsiella pneumonia（15.2%, 26/171）, Acinetobacter calcoaceticus-A. baumannii（13.4%, 23/171）and Pseudomonas aeruginosa（8.2%, 14/171） were the predominant species. Among A. calcoaceticus-A. baumannii isolates, 39.1%（9/23） of them were multidrug resistant strains. And 23.1%（6/26）of K. pneumonia isolates produced extended spectrum beta-lactamases. P. aeruginosa isolates showed high in vitro susceptibility to the antibacterial agents. Conclusion Pathogens are mainly isolated from sputum of patients after surgery for lung cancer. Canidia albicans and gram-negative bacilli are predominant isolates and should be the major targets for the prevention and treatment of postoperative infection.