Pharmacovigilance impact research(PIR),as an important application field of pharmacoepidemiology,has attracted continuous attention in recent years from drug regulatory authorities,pharmaceutical manufacturers,and the academic community both domestically and internationally.This paper provides an interpretation of PIR based on the Guide for Methodology in Pharmacoepidemiologic Research(2nd edition).First,an overview of the implications of PIR will be provided,focusing on the pathways of pharmacovigilance activities and the significant importance of conducting PIR.Second,it reviews commonly used study designs and presents illustrative case examples.Building on this,the specific statistical considerations relevant to PIR were discussed.Finally,the challenges and prospects of conducting pharmacovigilance impact studies in a scientific and standardized manner are summarized.Compared with the previous edition,the 2nd edition has expanded the application scenarios of pharmacoepidemiology to include new areas such as PIR.Drawing on the guideline content and practical experience,this paper provides a detailed introduction and case analysis of PIR,serving as a reference for researchers engaged in this field.

Objective:To study the current status of transitional readiness from adolescence to adulthood of patients with inflammatory bowel disease（IBD）in China,analyze the factors affecting transitional readiness,and provide a basis for developing scientific and targeted transitional preparedness programmes.Methods:The IBD patients aged 12-24 years who were admitted to the Department of Gastroenterology,Beijing Children's Hospital Affiliated to Capital Medical University from January 1,2016 to January 15,2025 were enrolled.From November 1,2024 to January 15,2025,the survey was conducted through online distribution of the transition readiness assessment questionnaire (TRAQ)6.0 Chinese version scale to IBD patients by using the convenient sampling method.The scores of each dimension of TRAQ scale were calculated,and multiple linear regression analysis was used to analyze the factors influencing the scores of TRAQ during the transitional period.Results:A total of 184 patients were included and 184 questionnaires were collected.Male patients were slightly more than female(109:75),with an average age of (14.94±2.35) years.70.11% of patients had a disease duration of 1 to 5 years,with Crohn's disease accounting for the highest proportion(54.89%),and the severity of the disease was mostly mild to moderate.Family support was generally higher(84.24%).Parents were highly involved in patient disease management(94.02%).There were 52.72% of the patients received social support.The mean score of the TRAQ was 4.14 ± 0.89,and the mean scores of the four dimensions from high to low were following health problems(4.28±0.97),insisting on making an appointment and seeing a doctor on time(4.20±1.10),talking with medical staff(4.17±1.05) and drug management(4.14±0.99).Multiple linear regression analysis showed that family status,the encourage,supports and help from the family members,and the supports from the society were the independent influencing factors of IBD patients' readiness score for transition from adolescence to adulthood( P<0.05).Among them,family status had a positive effect on transition readiness score,and the degree of readiness score increased with the increase of harmony( P<0.05).Social support also had a positive effect on transition readiness score( P<0.05).Compared with no encouragement,support and help from family members,the situation of little encouragement had a certain improvement on the readiness score( P<0.05). Conclusion:Children with IBD have better overall performance during the transition from adolescence to adulthood.Family status,the encourage,supports and help from the family members,and the supports from the society are the important factors influencing transitional preparedness.

Objective:By using cognitive interviews,the interviewees' cognition and understanding of the inflammatory bowel disease(IBD) self-efficacy scale for adolescents and young adults (IBDSES-A) were evaluated,and the semantic content of IBDSES-A,which was initially translated into Chinese,was tested and revised.Methods:Using purposive sampling,15 IBD patients aged 12-18 were selected from Beijing Children's Hospital,Capital Medical University,between January and February 2025,stratified by age group and disease type.Two rounds of cognitive interviews were conducted.Feedback and suggestions from interviewees were analyzed using a question appraisal system for coding and integration.Based on expert panel discussions,ambiguous items were revised to finalize the Chinese version of the IBDSES-A.Results:In the first round,10 interviewees were interviewed,followed by 5 interviewees in the second round.There were no statistically significant differences ( P>0.05) between the interviewees of two rounds in terms of age,gender,and education level.During the first round of interview,interviewees expressed comprehension difficulties with 76.9% (10/13) of the items.Coding analysis revealed that the primary issue was "clarification",as unclear wording made it difficult for interviewees to fully grasp the intended meaning of certain items.Based on these findings,the expert panel revised 10 of the 13 items in the IBDSES-A.The second round of cognitive interview showed that the interviewees generally understood the revised items，achieving linguistic and semantic consistency with the original scale. Conclusion:The application of cognitive interviews in the translation process of the IBDSES-A helps reduce comprehension biases caused by inappropriate wording，ensuring that the localized version of the scale is more accessible and understandable to the target population.

Objective:To investigate the treatment and prognosis of esophageal cancer patients with pulmonary resection history.Methods:The retrospective and descriptive study was conducted. The clinicopathological data of 58 esophageal cancer patients with pulmonary resection history who were admitted to Chest Hospital Affiliated to Shanghai Jiaotong University School of Medicine and Jiangxi Provincial People's Hospital from May 2019 to April 2024 were collected. There were 52 males and 6 females, aged (69±3)years. Observation indicators: (1) surgical and postopera-tive conditions; (2) postoperative pathological examination results; (3) follow-up; (4) stratified analysis. Comparison of measurement data with normal distribution between groups was conducted using the independent sample t test. Comparison of count data between groups was conducted using the chi-square test or Fisher exact probability. Comparison of ordinal data between groups was conducted using the non-parametric rank sum test. The Kaplan-Meier method was used to plot survival curve and calculate survival rate, and the Log-rank test was used for survival analysis. Results:(1) Surgical and postoperative conditions. Of the 58 esophageal cancer patients, 49 patients underwent transthoracic approach (26 cases of ipsilateral approach and 23 cases of contralateral approach of pulmonary resection history), and 9 patients underwent mediastinoscopic-laparoscopic approach. There were 57 cases with R 0 resection and 1 case with R 2 resection because of tumor invading carina. The total operation time of 58 patients was (246±27)minutes, and the volume of intraoperative blood loss was (114±29)mL. There was no unplanned reoperation or perioperative death for all patients. The duration of postoperative hospital stay of 58 patients was (10.4±4.6)days, and time for intensive care unit stay was (1.4±0.5)days, and no patient readmitted to intensive care unit due to changes in conditions. The postoperative total incidence of complications of 58 patients was 41.4%(24/58). The Clavien-Dindo grading of complications for all patients was 1-2 grade. (2) Postoperative pathological examination results. Results of postoperative pathological examination showed there were 51 cases of squamous cell carcinoma, 6 cases of adenocarcinoma, and 1 case of melanoma. Number of lymph node dissected of 58 patients was 27±6. The ratio of patient with positive lymph node was 37.9%(22/58). One patient may experience more than 1 region of positive lymph node metastasis. Results of postoperative pathological staging showed 5 cases of ⅠA stage, 2 cases of ⅠB stage, 13 cases of ⅡA stage, 15 cases of ⅡB stage, 4 cases of ⅢA stage, 16 cases of ⅢB stage, and 3 cases of ⅣA stage. Thirteen of the 58 patients underwent neoadjuvant therapy, with the pathological staging as 6 cases of Ⅰ stage, 4 cases of Ⅱ stage, 3 cases of ⅢB stage after therapy. Results of postoperative tumor regression grade for the 13 patients with neoadjuvant therapy showed 4 cases of grad 0, 3 cases of grade 1, 6 cases of grade 2. (3) Follow-up. All 58 patients were followed for 24 (4, 50)months, and no patient died within 90 days after surgery. During the follow-up period, 19 patients experienced tumor recurrence and metastasis and 17 patients died. Twenty-one patients underwent postoperative adjuvant therapy, including 7 cases with chemoradiotherapy, 7 cases with chemotherapy, 3 cases with chemotherapy and immunotherapy, 2 cases with immuno-therapy, 2 cases with radiotherapy. The postoperative 1-, 2-year overall survival rates of the 58 patients were 91.3%, 78.7%, respectively, of whom undergoing McKeown surgery and mediastinoscopic-laparoscopic surgery with postoperative 1-, 2-year overall survival rates as 89.2%, 83.1% and 85.7%, 53.6%, respectively. The postoperative 1-, 2-year esophageal cancer specific survival rates for patients undergoing McKeown surgery and mediastinoscopic-laparoscopic surgery were 94.4%, 87.9% and 85.7%, 71.4%, respectively. There was no significant difference in postoperative 1-, 2-year overall survival rates and postoperative 1-, 2-year esophageal cancer specific survival rates between patients undergoing McKeown surgery and mediastinoscopic-laparoscopic surgery ( P>0.05). (4) Stratified analysis. Of the 49 patients underwent transthoracic approach for esophageal cancer, there were significant differences in surgical method, surgical type, time of chest surgery, cases with upper mediastinal lymph node dissection, and duration of postoperative hospital stay between patients with pulmonary resection history as ipsilateral approach and contralateral approach ( χ2=11.74, 11.68, t=-2.25, χ2=8.45, t=-2.17, P<0.05), and there was no significant difference in total operation time, volume of intraoperative blood loss, the number of lymph node dissected, post-operative total complications, and postoperative pathological TNM staging ( P>0.05). For patients with pulmonary resection history as ipsilateral approach and contralateral approach, the postopera-tive 1-, 2-year esophageal cancer specific survival rates were 95.5%, 95.5% and 81.4%, 71.1%, showing a significant difference between them ( χ2=5.63, P<0.05). Conclusions:The transthoracic approach and mediastinoscopic-laparoscopic approach are safe and feasible for esophageal cancer patients with pulmonary resection history. Compared with patients with pulmonary resection history as contralateral approach, patients with pulmonary resection history as ipsilateral approach have a higher ratio of McKeown surgery, minimally invasive surgery and upper mediastinal lymph node dissection, shorter time of chest surgery and duration of postoperative hospital stay, better esophageal cancer specific survival rate. And there is no increase in perioperative risk.

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.

Pharmacovigilance impact research(PIR),as an important application field of pharmacoepidemiology,has attracted continuous attention in recent years from drug regulatory authorities,pharmaceutical manufacturers,and the academic community both domestically and internationally.This paper provides an interpretation of PIR based on the Guide for Methodology in Pharmacoepidemiologic Research(2nd edition).First,an overview of the implications of PIR will be provided,focusing on the pathways of pharmacovigilance activities and the significant importance of conducting PIR.Second,it reviews commonly used study designs and presents illustrative case examples.Building on this,the specific statistical considerations relevant to PIR were discussed.Finally,the challenges and prospects of conducting pharmacovigilance impact studies in a scientific and standardized manner are summarized.Compared with the previous edition,the 2nd edition has expanded the application scenarios of pharmacoepidemiology to include new areas such as PIR.Drawing on the guideline content and practical experience,this paper provides a detailed introduction and case analysis of PIR,serving as a reference for researchers engaged in this field.

Objective:To study the current status of transitional readiness from adolescence to adulthood of patients with inflammatory bowel disease（IBD）in China,analyze the factors affecting transitional readiness,and provide a basis for developing scientific and targeted transitional preparedness programmes.Methods:The IBD patients aged 12-24 years who were admitted to the Department of Gastroenterology,Beijing Children's Hospital Affiliated to Capital Medical University from January 1,2016 to January 15,2025 were enrolled.From November 1,2024 to January 15,2025,the survey was conducted through online distribution of the transition readiness assessment questionnaire (TRAQ)6.0 Chinese version scale to IBD patients by using the convenient sampling method.The scores of each dimension of TRAQ scale were calculated,and multiple linear regression analysis was used to analyze the factors influencing the scores of TRAQ during the transitional period.Results:A total of 184 patients were included and 184 questionnaires were collected.Male patients were slightly more than female(109:75),with an average age of (14.94±2.35) years.70.11% of patients had a disease duration of 1 to 5 years,with Crohn's disease accounting for the highest proportion(54.89%),and the severity of the disease was mostly mild to moderate.Family support was generally higher(84.24%).Parents were highly involved in patient disease management(94.02%).There were 52.72% of the patients received social support.The mean score of the TRAQ was 4.14 ± 0.89,and the mean scores of the four dimensions from high to low were following health problems(4.28±0.97),insisting on making an appointment and seeing a doctor on time(4.20±1.10),talking with medical staff(4.17±1.05) and drug management(4.14±0.99).Multiple linear regression analysis showed that family status,the encourage,supports and help from the family members,and the supports from the society were the independent influencing factors of IBD patients' readiness score for transition from adolescence to adulthood( P<0.05).Among them,family status had a positive effect on transition readiness score,and the degree of readiness score increased with the increase of harmony( P<0.05).Social support also had a positive effect on transition readiness score( P<0.05).Compared with no encouragement,support and help from family members,the situation of little encouragement had a certain improvement on the readiness score( P<0.05). Conclusion:Children with IBD have better overall performance during the transition from adolescence to adulthood.Family status,the encourage,supports and help from the family members,and the supports from the society are the important factors influencing transitional preparedness.