常规收集卫生数据是指基于管理和临床目的且事先没有特定研究目标而收集的数据，已被越来越多地用于研究。此类数据发展迅速，可及性好，但相关注意事项并未在现有的报告规范中被提及，如加强观察性流行病学研究报告的声明（strengthening the reporting of observational studies in epidemiology statement，STROBE）。使用常规收集卫生数据开展观察性研究的报告规范（the report of studies conducted using observational routinely collected data，RECORD）可填补该空缺。RECORD 规范是 STROBE 规范扩展版，其可用来提出针对使用常规收集卫生数据开展观察性研究有关报告的条件要求。RECORD 清单扩展了包括题目、摘要、前言、方法、结果、讨论和其他内容等需要在此类研究报告中包含的 13 个条目内容。该规范包括了清单、详尽的解释性信息以提高清单的使用。该规范还给出每条 RECORD 清单条目良好的报告实例。本文及其官网和留言板（http://www.record-statement.org）可提高 REDORD 规范的应用和理解。通过应用 RECORD，作者、期刊编辑和同行评议者可促进研究报告的质量。
Objective To investigate the association between parkin gene S/N167 polymorphism and the risk for Parkinson’s Disease (PD) using the methods of meta-analysis. Method References were retrieved through the computerized Medline, Cochrane Library and CBM search from 1998 to 2003. Similar search strategies were applied to each of these databases. The unpublished data of our study were also included.Studies eligible for this meta-analysis should meet the following inclusion criterias: ① presentation of original data and a cross-sectional design. ② PD as the outcome of interest. ③ an odds ratio (or enough information to calculate it) reported to quantify the association between the frequencies of genotypes and alleles of parkin gene S/N167 polymorphism and the risk for PD. All analyses were conducted with ’Review Manager’ Version 4.2 software. Results A total of 1 239 PD patients and 1 168 control studies were studied. The combined data statistics revealed the frequencies of the genotypes and alleles were higher, but showed no statistically difference, for the total PD group from that ofthe control group (Z=1.57, P=0.12). After stratification according to eastern or western origin, the frequencies of G/A+A/A genotype and a allele of eastern origin were significantly higher [test for overall effect: P=0.01, OR=1.41, 95%CI= (1.08 to1.83); P=0.01, OR=1.25, 95%CI= (1.08 to1.44), respectively] in the PD group than that in the control group. After including our unpublished data, the results remained constant, and the trend was much more pronounced. Conversely, there was no difference [test for overall effect: P=0.08, OR=0.55, 95%CI= (0.30 to1.02); P=0.08, OR=0.55, 95%CI= (0.28 to1.08)] in the frequencies of allele and genotype of western origin between the PD patients and the controls. Conclusions The meta-analysis suggests that the parkin gene S/N167 polymorphism might be a genetic risk factor for PD of eastern origin, but not a definite risk for PD of western origin.
Objective To investigate the effects of evidence-based medicine (EBM) course on clinical medical students and to propose teaching advice. Methods Using a predesigned questionnaire, we conducted an investigation on the literature retrieval, knowledge of EBM terms, and subject attitude of clinical 5-year and 7-year medical students before and after EBM course, and then an interview was performed to collect the opinions of the students. Data was statistically analyzed. Results After the course, average reading time and frequency of literature retrieval increased significantly compared to the situation before EBM course (Plt;0.05). Knowledge levels of main EBM terms related to practice increased significantly (Plt;0.05). 5-year medical students’ ability of literature appraisal also increased (Plt;0.05). In this interview, these students suggested that course time of literature retrieval and screening should increase and medical statistics should be reviewed. Conclusion Through the study of EBM course, both knowledge and attitude of students changed a lot, and combining case teaching with EBM course has a better teaching effect. Learning the concepts and techniques of EBM for clinical medical students can help them apply medical research evidence correctly in clinical practice, and train their self-learning ability.
A patient registry database is an important source of real-world data, and has been widely used in the assessment of drug and medical devices, as well as disease management. As the second part of the serial technical guidance for real-world data and studies, this paper introduces the concept and scope of potential uses of patient registry databases, proposes recommendations for planning and developing a patient registry database, and compares existing health and medical databases. This paper further develops essential quality indicators for developing a patient registry database, in expect to guide future studies.
Observational studies based on real-world data are providing increasing amount of evidence for evaluating therapeutic outcomes, which is important for timely decision-making. Although time and costs for data collection could be saved using real-world data, it is significantly more complex to design real world researches with lower risk of bias. In order to enhance the validity of causal inference and to reduce potential risk of bias in real world studies, the Working Group of China Real world data and studies Alliance (China REAL) has formulated recommendations for designing observational studies to evaluate therapeutic outcomes based on real-world data. This guidance introduces design types commonly used in real world research; recommends key elements to consider in observational studies, including sample selection, specifying and allocating exposures, defining study entry and endpoints, and pre-designing statistical analysis protocols; and summarizes potential biases and corresponding control measures in real-world studies. These recommendations introduces key elements in designing observational studies using real-world data, for the purpose of improving the validity of causal inference. However, the application scope of these recommendations may be limited and warrant constant improvement.
Traditional Chinese medicine (TCM) has a long history. In the process of fighting against diseases, TCM has formed a unique theoretical system and the way to think and diagnose. The holistic thinking, and the treatment according to syndrome differentiation are the most prominent characteristics of TCM, which matches with advanced medical concept and direction. The clinical efficacy has always been the basis for the advancement of TCM. However, issues such as the lagging behind of modern research on the evaluation of TCM curative effect, as well as lacking high-quality scientific research evidence, impede the development and promotion of the TCM toward the world. To address the above problems, recent progress in real-word study (RWS) has provided the opportunity for TCM researches, especially for the post-marketing evaluation of Chinese patent medicine (CPM). The formulation of this technical guidance for RWS of CPM is helpful to researchers in carrying out standardized, reasonable and scientific researches, to improve the quality of production and use of real-word evidence, and to promote the advancement of the TCM industry.
Neuroblastoma (NB) is the most common extracranial solid malignant tumor in children. NB has various clinical manifestations, many of which are not specific, which ultimately lead to the delayed diagnosis of the tumor. In order to provide guidance for the identification of paediatric NB, the guideline for the identification and referral of suspected paediatric neuroblastoma is formulated and complied using a standard formulation process, and has received input from multidisciplinary experts, based on existing evidence, clinical practices and China's national conditions.
With the acceleration of global innovative drug development, selecting safe, effective, and cost-effective products from numerous drugs has posed new challenges for the decision-making process of medical insurance drug access and dynamic updating of insurance directory. Real-world data (RWD) provides a new perspective for evaluation of clinical and economic value of drugs, but there are still uncertainties regarding the scope, quality standards, and evidence categories of RWD that can be used. Based on the current status of domestic and international RWD supporting the assessment of the clinical and economic value of drugs, this paper, in collaboration with national RWD and healthcare experts, has developed the key considerations for using real-world data to evaluate the clinical and economic value of drugs. This paper first clarifies the scope of RWD that can be used to evaluate the clinical and economic value of drugs evaluate; secondly, provides specific requirements and guidance on data attribution, data governance, and quality standards for RWD; finally, summarizes the evidence categories of RWD supporting evaluate the clinical and economic value of drugs evaluate.
Real-world data studies have experienced rapid development in recent years, however, misunderstandings persist. This paper aims to improve practice and promote standardization by updating the categorization of real-world data, proposing two conceptual frameworks for conducting real-world data studies, developing the concepts of research data infrastructure and clarifying the misconceptions on registry database, and discussing future development.
With the boom of information technology and data science, real-world evidence (RWE) which is produced using diverse real-world data (RWD) has become an important source for healthcare practice and policy decisions, such as regulatory and coverage decisions, guideline development, and disease management. The production of high-quality RWE requires not only complete, accurate and usable data, but also scientific and sound study designs and data analyses to enable the questions of interest to be reliably answered. In order to improve the quality of production and use of RWE, China REal world data and studies ALliance (ChinaREAL) has developed the first series of technical guidance for developing real-world data and subsequent studies. The efforts are ongoing which would ultimately inform better healthcare practice and policy decisions.