Objective To systematically review current status of Chinese DRIs, and compare the similarities and differences between Chinese and global DRIs, so as to provide references for regulating Chinese DRIs. Methods Such database as PubMed, ISI Web of knowledge, The Cochrane Library, CBM, WanFang Data, CNKI and VIP were electronically searched from inception to May 31st, 2013. The reviewers independently screened studies according to inclusion and exclusion criteria, extracted data. Then, descriptive analysis was performed for basic information of literature, formulation of different DRIs, and DRIs distribution by different ages. Results Initially, a total of 588 articles were retrieved, 42 of which were finally included, involving 14 guidelines, 12 systematic reviews (SRs), and 16 original studies. The results showed that, WHO guidelines and global systematic reviews focused on iron and fat-soluble vitamins (A and D); the original studies in China focused not only on iron and vitamin A but also on protein, calcium, zinc, and selenium. The included guidelines focused mainly on population aged 3-18 years old and pregnant women; and except for those two kinds of population, SRs also paid attention to adults aged more than 18 years. The original studies of Chinese DRIs were concerned about all kinds of population, mainly focused adults aged 18-45 years and school children aged 6-12 years. Among 16 included original studies, 4 were concerned about men and 2 about women. Conclusion Chinese DRIs need urgent updates and supplement. As the largest developing country, China has different disease burdens, consumption levels, dietary patterns, nutrients’ content, and security levels, compared with developed countries and other developing countries. To develop evidence-based Chinese DRIs that are suitable for native health and Chinese local conditions, we should drawing lessons from the currently available best DRIs standards, methods and evidence based on Chinese actual conditions, disease burden, and expert opinion.
The primary principle of evidence-based medicine is that the best clinical decision-making is derived from clinical problems with combination of patient’s preferences with clinical experience and the best evidence. Evidence-based medicine by its nature, is a specific application on the evaluation of medical hypothesis. It also emphasize the importance of humanism in clinical practice. Our study explored the scientific and humanistic characteristics of evidence-based medicine from the prospective of philosophy, so as to facilitate the extensive application of evidence based practice paradigm in other fields.
The majority of problems are comprehensive and complex in the modern society, which leads to the increasing contradictions in the specialization and comprehensiveness of knowledge. Interdisciplinary cooperation is one approach to improve the effectiveness and transferability. The primary principle of evidence-based medicine is its scientific and transparent procedures. It combines the patient’s preferences with clinical experience and the best evidence. Meanwhile, evidence-based medicine is focused on how to transfer research outcomes into practice and the re-evaluation of the result of practice in order to striving for perfections. Combining this practical pattern of evidence-based medicine with other disciplines can have a significant improvement on scientific methods and thinking patterns, and become an effective way to improve the quality of scientific research and promote the transformation.
The social needs, disciplinary development and humanistic reflection has promoted the emergence and development of evidence-based medicine. Moreover, evidence-based medicine-problems oriented research, evidence based decision, transferring results to practice and outcome evaluation-continues to meet society demands, promote the development of discipline and show humanist concern. The application of evidence-based medicine has gradually extended from the field of clinical medicine to the public health, society, management, economy, policy research and education in the process of solving various problems. The high quality evidence has also been important to decision-making in these fields. Our study explored the emergence and development of evidence-based medicine from the perspective of social needs, disciplinary development and humanistic reflection for the first time.
The increasing deteriorative trend of doctor-patient relationship (DPR) have destroyed patient safety, doctor safety and social stability in China. DPR is a complicated social problem related to multidisciplinary and multi-factor interactions. A series of researches providing different views on how to improve DPR in China have been published in recently years. Evidence-based medicine (EBM) aims to deal with massive information by producing, synthesizing and disseminating evidence from complex interventions. We tried to explore the trait of DPR by EBM methods. We provided evidence on research trends, topics and methods by systematic database retrieval, classification by screening, and quality assessment. Through dissection, attribution, and visualization of interactions and relationships between factors, we provided an evidence-supported framework for improvement of DPR. We identified gaps, defects or deficiencies in existing research, and promoted further research. We continued to follow up the research and faced a challenge: Reflection and frustration in the process of establishing the quality evaluation system of qualitative research. We found that the study of complex humanities and social sciences by reference to evidence-based methodology might be: providing a structured, panoramic perspective for complex social problems on " de-fragmentation”, providing a framework for social governance through classification and hierarchy, and calling for a more tolerant attitude and more comprehensive application of methodologies.
Science is a system of knowledge that reflects the essential connections and laws of the objective world. Classification of disciplines is a subsystem of science, which involves the development of human cognition which evolved from the scientific category to the department of higher education, and then formation of a complex management system. Nowadays with the rapid development of science and technology which triggering numerous complex social problems, an increasing trend of scientific integration calls for multidisciplinary and interdisciplinary research and education. In the 1990s, evidence-based medicine was emerged in the self-doubting of medical science, and extended to other fields of medicine, health policy and social sciences, forming an interdisciplinary evidence-based science system. Evidence-based science is an embodiment of scientific integration, and also the carrier and mechanism of cross-disciplinary convergence. It attempts to break through barriers of disciplines and management, and promotes interdisciplinary research, during which it has encountered many difficulties due to limitations of traditional disciplines. Evidence-based science does not provide an intrusion or transformation of thinking paradigm into other disciplines, but rather an equal dialogue to promote broader discipline collaboration and a new round of self-improvement, so as to constantly explore novel methods and theories to solve emerging problems, achieve continuous improvement, and pursue excellence.
Medicine bears the responsibility for human health. Technical competence, service standards, professional ethics and social accountability constitute the soul of this profession. The principles of nonmaleficence, beneficence, respect for autonomy and justice help to establish good doctor-patient relationship and regulate medical services, which has been fixed by international and domestic professional norms. Besides to ensure its truth, effectiveness and safety, medical research also should require certain rendering of subject's autonomy, minimizing risks and maintaining social justice. Some procedures have established for supporting it. Modern medical education furnishes suitable human resources for medical profession, which directly affects the accessibility and outcomes of health services. Its objectives, operations and assessments are increasingly taking shape. Faced with the current issues of healthcare equity, worsening doctor-patient relationship, scandals and ethical controversies in medical research, and the failing of medical education to fully match social needs, evidence-based medical methodology is extending to policy and social sciences for identifying and creating high-quality scientific evidence to improve the quality of decision-making.
ObjectivesTo evaluate the characteristics, main contents, key elements and techniques of global drug value assessment tools, especially for those developed for antineoplastic agents, and to provide reference for the establishment of the first value assessment tool for antineoplastic agents in China.MethodsDatabases including MEDLINE, EMbase, CBM, CNKI, VIP, WanFang Data and 19 relevant websites of institutions and societies were searched from inception to October 31st, 2018 to identify all the drug value assessment tools worldwide. Two independent reviewers screened the literatures, extracted the data and cross-checked them according to the inclusion and exclusion criteria. A qualitative analysis was conducted to describe the characteristics of these drug value assessment tools, including the publishing organization, year of publication, country, applicable type of disease and drug category, result display, and etc. Key elements and techniques in terms of evaluation dimensions, sources and levels of evidence, methods and procedures to form the tool were compared.ResultsA total of 12 English drug value assessment tools were included, which were published in 2010 to 2018 exclusively from Europe and North America. The applicable types of diseases and drug categories are not identical. The target users and stakeholders of each tool were slightly different. Evaluation dimensions, sources and levels of evidence, methods and procedures to form the tool were vital issues in value evaluation for drugs.ConclusionsThe structures of existing drug value assessment tools were almost the identical. However, there is no consensus on value definitions, evaluation dimensions, sources of evidence and result display. Methods and procedures to form the tool are not well described. It is urgent to explore and develop a value-oriented, focused and feasible drug assessment tool for antineoplastic agents in order to satisfy the strategic requirements of value-based post-marketing drug reevaluation.
Objective To evaluate the survival outcomes of segmentectomy versus lobectomy for T1c non-small cell lung cancer (NSCLC). Methods We searched PubMed, EMbase, Cochrane Central Register of Controlled Trials (CENTRAL), CNKI (China National Knowledge Infrastructure), and Wanfang Data, with the search time limit set from the inception of the databases to February 2024. Three researchers independently screened the literature, extracted relevant information, and evaluated the risk of bias of the included literature according to the Newcastle-Ottawa Scale (NOS). Meta-analysis was conducted using STATA 15.1. Hazard ratios (HRs) and their 95% confidence interval were pooled using an inverse variance-weighted approach, and heterogeneity was assessed using I-square (I2) statistic and Cochran’s Q test. Results A total of 8 retrospective cohort studies were included, involving 7,433 patients. The NOS scores of the included studies were all higher than 7 points. Among the 7 433 patients enrolled in eight eligible studies published from 2004 to 2022. The pooled adjusted HR found that patients who underwent lobectomy had significantly higher five-year OS compared to those who underwent lobectomy (adjusted HR=1.11, 95%CI 0.99-1.24, P=0.042). Compared with lobectomy, segmentectomy shows no significant difference in adjusted three-year OS and adjusted five-year LCSS of patients with T1c NSCLC (three-year OS: adjusted HR=0.88, 95%CI 0.62-1.24, P=0.468; five-year LCSS: adjusted HR=1.10, 95%CI 0.80-1.51, P=0.556). Moreover, there were no differences in the five-year adjusted RFS, and adverse events after the segmentectomy group were significantly less than those in the lobectomy group (five-year RFS: adjusted HR=1.23, 95%CI 0.82 to 1.85, P=0.319; complications: OR=0.57, 95%CI0.37 to 0.90, P=0.015). Subgroup analysis based on whether patients received neoadjuvant therapy showed that among studies that excluded patients who received neoadjuvant therapy, no significant difference in 5-year adjusted OS was observed between segmentectomy and lobectomy (adjusted HR=1.02, 95%CI 0.81 to 1.28, P=0.870). Conclusion Segmentectomy and lobectomy showed no significant difference in long-term survival in stage T1c NSCLC patients, with segmentectomy associated with fewer postoperative complications. Further high-quality research is needed to confirm the comparative efficacy and safety of lobectomy and segmentectomy for T1c NSCLC patients.
Artificial intelligence has been extensively applied in healthcare services recently, and clinical decision support systems driven by artificial intelligence are one of the applications. Early-stage clinical evaluation of artificial intelligence (AI)-based clinical decision support systems lies between preclinical development (in silico), offline validation, and large-scale trials, but few AI-related clinical studies have addressed human factors evaluations and reported the implementation environment, user characteristics, selection process and algorithm identification of AI systems. In order to bridge the development-to-implementation gap in clinical artificial intelligence and to promote the transparent and standardized reporting of early-stage clinical studies of AI-based decision support systems. A reporting guideline for the developmental and exploratory clinical investigations of decision support systems driven by artificial intelligence (DECIDE-AI) was published in 2022. This paper aimed to interpret the background, development process and key items of the DECIDE-AI guideline and promote its understanding as well as dissemination in China.