Appropriate data sources are the cornerstone of pharmacoepidemiological research.Based on the Guide on Methodological Standards in Pharmacoepidemiology in China(2nd edition),hereinafter referred to as"the Guideline(2nd edition)",this article provides an in-depth interpretation of the classification and selection of data sources in pharmacoepidemiological research.It begins with a brief overview of the evolution of data sources in pharmacoepidemiological studies,followed by a detailed analysis of the definitions,applicable scopes,conditions of use,and strengthens and limitations of primary and secondary data sources.It further introduces the characteristics of common data sources and relevant classic domestic and international databases.Subsequently,integrating aspects of the Guideline(2nd edition),including research questions,study design,study population,sample size,exposure or intervention,outcomes,and covariates,the article discusses the criteria and strategies for choosing data sources in pharmacoepidemiological research.Ultimately,a data source selection methodology is established based on clear classification,guided by research questions,tailored to research methods,and supported by data quality,aiming to promote the development of high-quality pharmacoepidemiological research in China.

Objective:To describe the epidemiological characteristics of 22 common respiratory patho-gens in patients with pneumonia in Yinzhou,Ningbo,from January 1,2015 to December 21,2024.Methods:The test data of 22 common respiratory pathogens in patients diagnosed with pneumonia or lung infection in the Yinzhou Regional Health Information Platform from January 1,2015 to December 21,2024 were collected.The positive cases,positive rates,and positive proportions were calculated.The epidemiological characteristics were described by the year,sex,age group,season,and coronavirus disease 2019(COVID-19)pandemic period.Results:A total of 77 531 pneumonia patients were included,with 492 696 respiratory pathogen tests performed.The number of respiratory pathogen tests and positive cases of pneumonia patients in Yinzhou showed an upward trend.In the study,34.63％of the pneumo-nia patients tested positive for at least one pathogen,and the pathogen non-detection rate decreased from 79.44％in 2015 to 58.38％in 2024.The overall pathogen positive rate was 9.12％,which decreased during the COVID-19 pandemic and had not returned to the historical level after the COVID-19 pande-mic.The positive rate was highest in children aged 6-17 years(13.99％),and lowest in the elderly over 60 years(4.16％).The top 3 highest number of positive cases was Mycoplasma pneumoniae,influenza A virus,and influenza B virus;the top 3 highest positive rates of pathogen tests were Mycoplasma pneu-moniae(25.26％),rhinovirus(12.02％),and Bordetella pertussis(11.66％).The pathogen spectrum proportion in men was similar to that in women,only showing a higher ratio of Mycobacterium tuberculosis and a slightly lower ratio of Mycoplasma pneumoniae(P＜0.001).Mycoplasma pneumoniae,respiratory syncytial virus,and rhinovirus infections were more common in children,while influenza virus,Mycobac-terium tuberculosis,and Streptococcus pyogenes infections were more common in adults and the elderly(P＜0.001).Influenza virus and human metapneumovirus infections were more common in winter,rhi-novirus and Bordetella pertussis infections were more common in spring,and Mycoplasma pneumoniae in-fections were relatively more common in fall(P＜0.001).After the COVID-19 pandemic,the propor-tions of rhinovirus,respiratory syncytial virus,and human metapneumovirus infections in the pneumonia patients increased signi-ficantly,reaching 7.53％,4.26％,and 2.25％,respectively,while the propor-tions of influenza B virus and Mycobacterium tuberculosis infections decreased to 4.14％and 2.80％,re-spectively(P＜0.001).Conclusion:In the past decade,the scale of respiratory pathogen infection in the pneumonia population in Yinzhou had expanded significantly,and there were differences in distribu-tion by the year,gender,age group,and season.The respiratory pathogen spectrum in pneumonia pa-tients after the COVID-19 pandemic had a trend of diversification.

Objective:To describe the epidemiological characteristics and changes of febrile seizure(FS)among children under 6 years old in Ningbo City,Zhejiang Province from 2015 to 2021.Methods:Based on the Ningbo Regional Health Information Platform,a dynamic cohort was established using vacci-nation registration information,and the cases of FS were identified by the diagnostic results of Chinese terms or International Classification of Diseases 10th revision(ICD-10)R56.0 code in the electronic medical records.The first visit of FS during the observation period was defined as a new case,and a re-currence case was defined as the case with a visit interval of more than 7 days.The 95％confidence in-terval(CI)of FS incidence density was calculated by the Poisson distribution.Results:From January 2015 to June 2020,there were 1.3 million children under 6 years old in Ningbo,with male accounting for 52.87％.The median follow-up time was 2.83(1.55-4.00)years.During the follow-up period,12 776 new onset cases had FS,with more males than females,with an overall incidence density of 4.34(95％CI:4.27-4.40)/1 000 person-years and a recurrence rate of 21.63％.There was a higher inci-dence density in children who were male,born in Ningbo and of non-mobility.The incidence density of FS was higher in urban areas than in rural and rural-urban fringe areas,and the incidence density was different among districts and counties.The peak density was found in children aged 18-23 months[8.42(95％CI:8.11-8.74)/1 000 person-years].From 2015 to 2019,the incidence density in-creased with calendar year(Ptrend＜0.001),and the highest was 5.62(95％CI:5.43-5.81)/1 000 person-years.The incidence density of FS decreased significantly during the period between 2020 and 2021.The incidence density was higher in winter.Conclusion:From 2015 to 2019,the overall inci-dence density of FS in children under 6 years old in Ningbo City presented an increasing trend.More at-tention should be paid to the health education,the improvement of the health maintenance model,the en-hancement of the cognition of FS,the identification and treatment of FS among high-risk population and regions so as to prevent its recurrence and reduce the disease burden during the corona virus disease 2019(COVID-19)epide-mic.

Objective:To analyze the characteristics of Hashimoto thyroiditis(HT)and Graves disease(GD),two autoimmune thyroid diseases aged 10-59 in Qingdao City from 2022 to 2024,and to provide scientific basis for making targeted prevention and treatment measures.Methods:A cross-sectional study design was adopted,based on the data of the Regional Health Information Platform in Qingdao,the con-firmed cases of HT and GD from 2022 to 2024 were included,and combined with the data of the seventh population census,the three-year and annual prevalence rates of HT and GD were calculated,and the time trend of annual prevalence was analyzed by Cochran-Armitage trend test.The distribution characte-ristics of HT and GD prevalence in different age groups and regions were analyzed,and Chi-square test was used to compare the differences between the groups.Results:The total number of HT patients among women aged 10-59 in Qingdao City from 2022 to 2024 was 40 362.The proportion of HT patients in 30-34 years old was the highest(19.83％).The proportion of HT patients in Huangdao District was the highest(17.72％).The three-year prevalence of HT was 1 206.53/100 000.In 2022-2024,the annual prevalence of HT increased significantly(P＜0.001),from 385.32/100 000 in 2022 to 1 206.32/100 000 in 2024.The three-year prevalence of HT was significantly different in age distribution(P＜0.001).The three-year prevalence of HT in 25-29 years(2 354.44/100 000)and 35-39 years(2 022.20/100 000)was higher than that in other age groups,showing a bimodal distribution.There were significant differences in the three-year prevalence of HT in different regions(P＜0.001),among which the three-year prevalence of HT in Shinan District was the highest(2 392.90/100 000),followed by Licang Dis-trict(1 492.41/100 000),and Laixi City was the lowest(659.940/100 000).The total number of GD patients was 2 095,among which the proportion of GD patients in the 35-39 age group was the highest(15.42％),and the proportion of GD patients from Jimo District was the highest(12.27％).From 2022 to 2024,the three-year prevalence rate of GD was 62.63/100 000,and the annual prevalence rate of GD showed an increasing trend(P＜0.001),from 20.33/100 000 in 2022 to 62.63/100 000 in 2024.There were significant differences in the prevalence of GD by age(P＜0.001).The three-year prevalence of GD reached the highest value in the 25-29 age group(98.90/100 000),followed by the 35-39 age group(85.21/100 000),and the lowest in the 10-14 age group(14.43/100 000).In the regional distribution,there were significant differences in the 3-year prevalence of GD(P＜0.001).Laoshan District had the highest three-year prevalence of GD(107.58/100 000),followed by Shinan District(97.83/100 000)and Huangdao District(28.92/100 000).Conclusion:The three-year pre-valence of HT and GD in females aged 10-59 years in Qingdao City from 2022 to 2024 is low,but the annual prevalence is on the rise,and the three-year prevalence of HT and GD in females aged 25-39 years is higher than that in other age groups,so it is necessary to strengthen the screening and monitoring of this population.

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 field that applies epidemiological methods to study drug use,effectiveness,and associated risk in populations.Standardizing research methods in this field is crucial for ensuring research quality and promote the development of the discipline.Based on the Guide on Methodological Standards in Pharmacoepidemiology in China(2nd edition),this article interprets the relevant contents about classic research types and their derivative designs.It aims to clarify the types of study methodological designs in pharmacoepidemiology,systematically describe the characteristics and applications classical derivative designs,and compare these with research design frameworks outlined in international pharmacoepidemiological guidelines.Compared to the first edition,the second edition of the guideline has updated and detailed the types of research,updating the research design to original research(interventional research and non-interventional research),secondary research(systematic review,Meta-analysis,economic analysis,etc.),and tertiary research(umbrella review,etc.).Additionally,a variety of derivative designs have been added,including target trial emulation,nested case-control and case-cohort studies,case-crossover designs,self-controlled case series and self-controlled risk interval designs,case-population studies,interrupted time-series analysis,and case-coverage(ecological)designs for vaccine surveillance.This article strengthens the operability of the theoretical guidance of pharmacoepidemiological research methods in practice and provides a reference for conducting high-quality pharmacoepidemiological research.

Formulating a well-defined research question and developing a scientifically sound study protocol is important for ensuring the quality of pharmacoepidemiological research.Based on the Guide on Methodological Standards in Pharmacoepidemiology in China(2nd edition),this research provided an interpretation of the sections related to the formulation of research questions and the development of study protocols.First,it clarified the sources and scope of research questions,outlining a two-step approach—question generation and definition—and introduces relevant evaluation tools and defining frameworks.Furthermore,it systematically explained the key elements of a study protocol and provides an in-depth explanation of the research methodology and its critical aspects.Finally,the paper highlighted the importance of feasibility assessment,emphasizing that the process of defining research questions and study protocols is dynamic and iterative.Compared with the previous edition,the 2nd edition of the guidelines offers more detailed and updated guidance on question formulation and protocol development.It added three new elements—such as protocol archiving or registration—and three new content items,including study objectives.The 2nd edition also expanded the methodological framework and strengthens feasibility assessments,thereby enhancing the comprehensiveness and rigor of its practical guidance.By integrating guideline content with practical experience,this paper provided insights into its implications for pharmacoepidemiological research and serves as a reference for researchers in the field.

Objective To develop and validate a prediction model to identify high-risk individuals who are at-risk to develop acute liver injury(ALI)within 180 days in new statin users,and to support early clinical intervention.Methods Data were sourced from the Yinzhou Regional Health Information Platform,covering statin initiators aged 18 years and older from January 1,2010,to October 31,2021.The dataset was divided into a derivation cohort and a temporal validation cohort based on the time of statin initiation.Predictors were selected using LASSO regression,and the model was constructed using the extreme gradient boosting(XGBoost)algorithm combined with cost-sensitive learning.Model performance was evaluated using Brier scores,Harrell's C-index,and calibration curves.Results A total of 126,440 statin initiators were included,with 90,542 in the derivation cohort and 35,898 in the validation cohort.Within 180 days of initial statin use,412(0.33％)patients developed ALI,including 305(0.34％)in the derivation cohort and 107(0.30％)in the validation cohort.The final model incorporated 16 predictors,which included demographic characteristics,lifestyle factors,family history,medical history,statin use,and concomitant medication use.The model demonstrated excellent overall performance[Brier score=0.0043,95％CI(0.0038,0.0049)],discrimination[Harrell's C-index=0.761,95％CI(0.725,0.794)],and calibration in internal validation.In temporal validation,the model also performed well[Brier score=0.0044,95％CI(0.0036,0.0052),Harrell's C-index=0.703,95％CI(0.614,0.781)].Conclusion This study develope and validate a prediction model for ALI in statin users,providing clinicians with a reliable tool for individualized risk assessment.This model can help achieve risk stratification and reduce the occurrence of ALI.

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.