It has been not been updated for nearly 5 years since the Pharmacoepidemiology Professional Committee of the Chinese Pharmaceutical Association released the Guide on Methodological Standards in Pharmacoepidemiology in China(1st edition)in 2019,and an update is urgently needed.This study adopts a systematic review approach to comprehensively search for global pharmacoepidemiology methodological guidelines and analyze their development status.By extracting the frameworks and key elements of the guidelines,the China's guide was compared with other included guidelines,its shortcomings were analysed,and pragmatic and feasible suggestions for improvement in line with China's national conditions,were proposed in order to provide references for updating China's guide.A systematic search was conducted by searching PubMed,Embase,CNKI,WanFang Data and 17 official websites of international academic organizations for pharmacoepidemiology and regulatory agencies from countries or regions including Europe,the United States,Japan,and China,etc.,and relevant guidelines or standards were screened based on predefined inclusion and exclusion criteria,resulting in the inclusion of 33 methodological guidelines or standards for pharmacoepidemiological studies.A qualitative synthesis approach was then employed to extract core elements from the guidelines through thematic categorization and content summarization,followed by a descriptive comparative analysis.The results indicate that the 1st edition of the China's guide provides relatively comprehensive guidance on adverse drug reaction reporting and publication of research findings.However,there are gaps in study protocol development,data analysis during study implementation,study reporting,and specific study scenarios.By integrating and drawing upon the latest international pharmacoepidemiology methodology guidelines while balancing comprehensiveness,practicality,and user-friendliness,this study provides recommendations for updating the China's guide.

It has been not been updated for nearly 5 years since the Pharmacoepidemiology Professional Committee of the Chinese Pharmaceutical Association released the Guide on Methodological Standards in Pharmacoepidemiology in China(1st edition)in 2019,and an update is urgently needed.This study adopts a systematic review approach to comprehensively search for global pharmacoepidemiology methodological guidelines and analyze their development status.By extracting the frameworks and key elements of the guidelines,the China's guide was compared with other included guidelines,its shortcomings were analysed,and pragmatic and feasible suggestions for improvement in line with China's national conditions,were proposed in order to provide references for updating China's guide.A systematic search was conducted by searching PubMed,Embase,CNKI,WanFang Data and 17 official websites of international academic organizations for pharmacoepidemiology and regulatory agencies from countries or regions including Europe,the United States,Japan,and China,etc.,and relevant guidelines or standards were screened based on predefined inclusion and exclusion criteria,resulting in the inclusion of 33 methodological guidelines or standards for pharmacoepidemiological studies.A qualitative synthesis approach was then employed to extract core elements from the guidelines through thematic categorization and content summarization,followed by a descriptive comparative analysis.The results indicate that the 1st edition of the China's guide provides relatively comprehensive guidance on adverse drug reaction reporting and publication of research findings.However,there are gaps in study protocol development,data analysis during study implementation,study reporting,and specific study scenarios.By integrating and drawing upon the latest international pharmacoepidemiology methodology guidelines while balancing comprehensiveness,practicality,and user-friendliness,this study provides recommendations for updating the China's guide.

Pharmacoepidemiology is an interdisciplinary discipline that applies epidemiological research methods to evaluate the application and effect of drugs within population.Standardizing pharmacoepidemiological research methods is crucial for ensuring the quality of research and promoting the development of the discipline.The Pharmacoepidemiology Professional Committee of Chinese Pharmaceutical Association developed the Guide on Methodological Standards in Pharmacoepidemiology(1st edition),in 2019,but has not been updated in over five years.Other,countries/regions such as Europe,America,Japan and South Korea have made a lot of progress in developing and updating the guidelines.Therefore,the rapid development of pharmacoepidemiology in our country and the growing need to align with international standards make it essential to update the guidelines.The second edition of the guidelines was developed through a process that included systematic reviews,practical surveys,and multidisciplinary collaboration.Compared with the first edition,the updated version has made many important changes in research design,data sources,specific application scenarios and more,and added new contents such as the application of artificial intelligence.The purpose of this paper is to emphasize the necessity of updating the guidelines,selecting important changes and formulating interpretation plans.It aims to provide references for relevant professionals to comprehensively understand and apply the new guidelines,and to promote the standardized development and quality of pharmacoepidemiologic research in our country,further advancing the field.

Pharmacoepidemiology is a scientific discipline that applies epidemiological principles and methods to study the utilization and effects of pharmaceuticals in populations.It plays a crucial role in promoting rational drug use and improving public health outcomes.High-quality pharmacoepidemiological research relies on rigorous methodological frameworks.Chinese Pharmaceutical Association(CPA)has officially initiated the development/revision of the of the Guide on Methodological Standards in Pharmacoepidemiology in China(2nd edition)in 2024.This revision project was supported by the Pharmacoepidemiology Committee of CPA,and was led by the Department of Epidemiology and Biostatistics at Peking University School of Public Health,which provided methodological guidance,in collaboration with multidisciplinary experts from across the country.Building on the experience of the 1st edition's development,the working group conducted a qualitative systematic review,to extract key information from global pharmacoepidemiology-related guidelines,laying the foundation for the development/revision proposals of the 2nd edition.Subsequently,through two rounds of Delphi method expert consultations and qualitative interviews,alongside extensive discussions within the working group,the draft revision of the guideline was created.Finally,through an expert consensus meeting using the Nominal Group Technique(NGT),a consensus was reached,resulting in a methodological guideline that integrates international perspectives with local applicability for pharmacoepidemiological research in China.The 2nd edition consists of 41 entries,including 8 primary entries,20 secondary entries,and 13 tertiary entries.It comprehensively covers key aspects such as study protocol development,study implementation,adverse event reporting,research report writing,and dissemination of study findings.Additionally,it addresses specific application scenarios and topics,as well as the application of artificial intelligence and real-world studies.

Objective:To investigate the changes in N100, P300, and N400 of event-related potential(ERP) in children with obstructive sleep apnea (OSA), and provide the basis for evaluating cognitive and neurological impairment in pediatric OSA.Methods:Totally 108 children aged 5-10 years who visited the Sleep Center of Beijing Children's Hospital due to snoring or mouth breathing were recruited from June to September, 2023, and ultimately 90 children were included in the study.According to the obstructive sleep apnea hypopnea index (OAHI) in their polysomnography (PSG) results, children with OAHI>1 time/h were classified as OSA group ( n=74), and children with OAHI ≤ 1 time/h were classified as non-OSA group ( n=16).All participants completed the auditory oddball and Peabody image vocabulary test tasks, and the EEG data collected through ERP technology were compared between the two groups.SPSS 26.0 software was used for statistical analysis, and independent samples t-test or non parametric test was used for comparison between the two groups. Results:The P300 latency of OSA children in lead Fz was significantly longer than that of non OSA children (330.00(308.00, 396.00) ms, 309.00(294.50, 337.50)ms), and the difference was statistically significant ( Z=-2.143, P=0.032). The latency of P300 was positively correlated with apnea hypopnea index(AHI)(Fz lead: r=0.332, Cz lead: r=0.239, Pz lead: r=0.213, all P<0.05). There was no statistically significant difference in P300 latency between Cz and Pz leads ( Z=-1.615, P=0.106; Z=-1.055, P=0.291). There was no statistically significant difference in the amplitude of P300 among the leads (all P>0.05). There was no statistically significant difference in the amplitude and latency of N100 and N400 (both P>0.05). Conclusion:The latency of P300 in OSA children is significantly longer than that in non-OSA children, indicating impaired cognitive function. The latency of auditory P300 might serve as an early neuroelectrophysiological biomarker for identifying cognitive impairment in OSA children.

Objective:To investigate the changes in N100, P300, and N400 of event-related potential(ERP) in children with obstructive sleep apnea (OSA), and provide the basis for evaluating cognitive and neurological impairment in pediatric OSA.Methods:Totally 108 children aged 5-10 years who visited the Sleep Center of Beijing Children's Hospital due to snoring or mouth breathing were recruited from June to September, 2023, and ultimately 90 children were included in the study.According to the obstructive sleep apnea hypopnea index (OAHI) in their polysomnography (PSG) results, children with OAHI>1 time/h were classified as OSA group ( n=74), and children with OAHI ≤ 1 time/h were classified as non-OSA group ( n=16).All participants completed the auditory oddball and Peabody image vocabulary test tasks, and the EEG data collected through ERP technology were compared between the two groups.SPSS 26.0 software was used for statistical analysis, and independent samples t-test or non parametric test was used for comparison between the two groups. Results:The P300 latency of OSA children in lead Fz was significantly longer than that of non OSA children (330.00(308.00, 396.00) ms, 309.00(294.50, 337.50)ms), and the difference was statistically significant ( Z=-2.143, P=0.032). The latency of P300 was positively correlated with apnea hypopnea index(AHI)(Fz lead: r=0.332, Cz lead: r=0.239, Pz lead: r=0.213, all P<0.05). There was no statistically significant difference in P300 latency between Cz and Pz leads ( Z=-1.615, P=0.106; Z=-1.055, P=0.291). There was no statistically significant difference in the amplitude of P300 among the leads (all P>0.05). There was no statistically significant difference in the amplitude and latency of N100 and N400 (both P>0.05). Conclusion:The latency of P300 in OSA children is significantly longer than that in non-OSA children, indicating impaired cognitive function. The latency of auditory P300 might serve as an early neuroelectrophysiological biomarker for identifying cognitive impairment in OSA children.

Evidence-based public health, as the forefront of modern public health practice, has increasingly important in public health field. However, a significant gap remains between the available evidence and its practical application. Effectively disseminating and implementing evidence-based public health practice in real-world settings has become a key challenge in contemporary public health research. In this context, Implementation Science has emerged as a vital discipline. This paper explores the critical role of Implementation Science in public health, reviews the origins and core components of the Consolidated Framework for Implementation Research (CFIR), and analyzes the current application of CFIR in public health through bibliometric methods. Additionally, it discusses specific examples to further elucidate the steps involved in using the CFIR and its application contexts. The findings indicate that since 2015, research on CFIR in public health has progressively increased, showing a continuous upward trend. CFIR applications mainly address context-specific facilitators, health decision-making, barrier and facilitator identification, and community-based participatory evaluation, predominantly employing qualitative and mixed-methods research. This paper not only reviews and analyzes the current use of CFIR in public health but also provides a detailed discussion on its application. The goal is to offer valuable insights for the development of Implementation Science research within China's public health sector.

Pharmacoepidemiology is a scientific discipline that applies epidemiological principles and methods to study the utilization and effects of pharmaceuticals in populations.It plays a crucial role in promoting rational drug use and improving public health outcomes.High-quality pharmacoepidemiological research relies on rigorous methodological frameworks.Chinese Pharmaceutical Association(CPA)has officially initiated the development/revision of the of the Guide on Methodological Standards in Pharmacoepidemiology in China(2nd edition)in 2024.This revision project was supported by the Pharmacoepidemiology Committee of CPA,and was led by the Department of Epidemiology and Biostatistics at Peking University School of Public Health,which provided methodological guidance,in collaboration with multidisciplinary experts from across the country.Building on the experience of the 1st edition's development,the working group conducted a qualitative systematic review,to extract key information from global pharmacoepidemiology-related guidelines,laying the foundation for the development/revision proposals of the 2nd edition.Subsequently,through two rounds of Delphi method expert consultations and qualitative interviews,alongside extensive discussions within the working group,the draft revision of the guideline was created.Finally,through an expert consensus meeting using the Nominal Group Technique(NGT),a consensus was reached,resulting in a methodological guideline that integrates international perspectives with local applicability for pharmacoepidemiological research in China.The 2nd edition consists of 41 entries,including 8 primary entries,20 secondary entries,and 13 tertiary entries.It comprehensively covers key aspects such as study protocol development,study implementation,adverse event reporting,research report writing,and dissemination of study findings.Additionally,it addresses specific application scenarios and topics,as well as the application of artificial intelligence and real-world studies.

Pharmacoepidemiology is an interdisciplinary discipline that applies epidemiological research methods to evaluate the application and effect of drugs within population.Standardizing pharmacoepidemiological research methods is crucial for ensuring the quality of research and promoting the development of the discipline.The Pharmacoepidemiology Professional Committee of Chinese Pharmaceutical Association developed the Guide on Methodological Standards in Pharmacoepidemiology(1st edition),in 2019,but has not been updated in over five years.Other,countries/regions such as Europe,America,Japan and South Korea have made a lot of progress in developing and updating the guidelines.Therefore,the rapid development of pharmacoepidemiology in our country and the growing need to align with international standards make it essential to update the guidelines.The second edition of the guidelines was developed through a process that included systematic reviews,practical surveys,and multidisciplinary collaboration.Compared with the first edition,the updated version has made many important changes in research design,data sources,specific application scenarios and more,and added new contents such as the application of artificial intelligence.The purpose of this paper is to emphasize the necessity of updating the guidelines,selecting important changes and formulating interpretation plans.It aims to provide references for relevant professionals to comprehensively understand and apply the new guidelines,and to promote the standardized development and quality of pharmacoepidemiologic research in our country,further advancing the field.

Objective:To explore the efficacy and surgical seletion or timing for elderly patients(≥85 years) with inguinal hernia.Methods:A retrospective analysis was conducted on clinical data of 323 patients aged ≥ 85 years who underwent surgical treatment for inguinal hernia admitted to the Department of General Surgery of East China Hospital Affiliated to Fudan University from Jan 2020 to Dec 2024.There were 308 males (95.36%) and 15 females (4.64%), with an average age of (87.83 ± 1.91) years. The ASA classification included 15 cases of grade Ⅰ, 209 cases of grade Ⅱ, 97 cases of grade Ⅲ, and 2 cases of grade Ⅳ.Results:Among the 323 patients, there were 20 bilateral hernia cases and 303 unilateral cases. Ninety-seven cases were of scrotal hernia. Surgical methods included 11 TAPP cases, 10 TEP cases, 297 Lichtenstein cases, 3 open suture repair and 2 laparoscopic suture repair. Four cases underwent intestinal resection and in two cases enterostomy was performed. The median follow-up after surgery was 3 months. Hernia recurrence was found in 2 cases, seroma in 14 cases, chronic pain in 2 cases, SSI in 11 cases, intestinal obstruction in 1 case, urinary retention in 3 cases, pulmonary infection in 9 cases, urinary tract infection in 2 cases, cardiovascular and cerebrovascular accidents in 2 cases. The incidence of postoperative complications in the emergency group was significantly higher than that in the elective group. Three deaths occurred within 30 days after surgery, all of which were in the emergency group.Conclusions:Selective inguinal hernia repair is safe and effective for over 85 year old patients with inguinal hernia. The incidence of emergency surgical complications and mortality is significantly increased. Lichtenstein surgery under local anesthesia or regional block anesthesia is the preferred method.