1.Proctor's Reporting Guideline for Implementation Strategies: Interpretation, Application, and Challenges
Jiangyun CHEN ; Jinghan LIU ; Youping ZHUANG ; Xueying CHEN ; Siyuan LIU ; Xiaoshan CHEN ; Yeqing ZHAN ; Dongmei ZHONG ; Huadan HUANG ; Dong XU
Medical Journal of Peking Union Medical College Hospital 2026;17(1):263-273
The Proctor's reporting guideline for implementation strategies represents a landmark framework in the field of implementation science, aiming to address the issue of inconsistent reporting in implementation research by standardizing the naming, definition, and operationalization of implementation strategies, thereby enhancing the credibility and utility of research findings. This paper provides an in-depth interpretation of the core connotations of this reporting guideline and illustrates its application in developing interview outlines and specifying implementation strategies, using a brief smoking cessation intervention project as a case study. Through this reporting guideline, abstract recommendations for implementation are systematically transformed into clear, multidimensional operational guides, significantly improving the transparency of strategy connotations and the replicability of actual execution. Meanwhile, the case study highlights the flexibility of the guideline, which allows researchers to adapt the content and format of strategies based on local resources and cultural contexts, thus enhancing practical adaptability while maintaining scientific rigor. However, the application of Proctor's reporting guideline still faces challenges, primarily manifested in the potential confusion surrounding the constructs of temporality and dose in practice, as well as the challenges that the inherent flexibility of the guideline may pose to the assessment of fidelity and effectiveness. Despite these limitations, the reporting guideline remains a vital tool for implementation research; future efforts should focus on optimizing its application—through refining operational guidelines, standardizing flexible adaptations, and involving stakeholders—to better guide implementation studies and continuously promote high-quality development in the field.
2.Effect of Heat-sensitive Moxibustion on Quality of Life and Immune Function in Non-Small Cell Lung Cancer Patients with Qi Deficiency and Phlegm Stasis Syndrome Undergoing Chemotherapy:A Randomized Controlled Trial
Wenhao ZHAN ; Qian DING ; Zhiwei DONG ; Ting LI ; Shumei FU ; Ning TIAN
Journal of Traditional Chinese Medicine 2026;67(12):1289-1296
ObjectiveTo observe the effect of heat-sensitive moxibustion on quality of life and immune function in non-small cell lung cancer (NSCLC) patients undergoing chemotherapy. MethodsSeventy NSCLC patients with qi deficiency and phlegm stasis syndrome were randomly divided into an intervention group and a control group, with 35 cases in each group. The control group received chemotherapy combined with routine symptomatic treatment, while the intervention group additionally received heat-sensitive moxibustion since the first day of chemotherapy. Acupoints included Dazhui (GV14), bilateral Feishu (BL13), Zhongwan (CV12), Qihai (CV6), and Guanyuan (CV4). The site exhibiting the strongest heat-sensitization response was selected for moxibustion. Treatment was administered for 45 minutes per session, three times weekly for three consecutive weeks, totaling nine sessions. Before and after treatment, quality of life was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), and traditional Chinese medicine (TCM) syndrome scores were evaluated. Peripheral blood levels of natural killer (NK) cells and T-lymphocyte subsets including CD3+, CD4+, and CD8+, and CD4+/CD8+ ratio were measured. Levels of programmed cell death protein-1 (PD-1), including PD-1⁺CD4⁺ and PD-1⁺CD8⁺ cells, were also assessed. Liver and renal function were monitored before and after treatment, and adverse events were recorded. ResultsIn the intervention group, 1 participant withdrew and 1 was excluded, while in the control group, 2 participants withdrew. Ultimately, 33 participants in each group were included in the final analysis. The intervention group showed significant improvements in physical, role, emotional, cognitive, and social functioning, as well as global health status after treatment, while scores for fatigue, nausea and vomiting, dyspnea, appetite loss, diarrhea, and TCM syndrome scale were significantly decreased (P<0.05). Moreover, the intervention group demonstrated higher scores in physical functioning, role functioning, and global health status, as well as lower scores for fatigue, nausea and vomiting, dyspnea, appetite loss, diarrhea, and the TCM syndrome scale than the control group (P<0.05). After treatment, the levels of peripheral NK cells and PD-1⁺CD8⁺ T cells in the intervention group increased significantly; furthermore, the intervention group exhibited higher peripheral NK cell levels and lower PD-1⁺CD8⁺ T cell levels than the control group (P<0.05). No significant differences were found in liver or renal function between the two groups (P>0.05). In addition, no adverse events such as burns or moxibustion-induced syncope occurred during the study. ConclusionHeat-sensitive moxibustion as an adjunctive therapy may enhance immune function, alleviate clinical symptoms, and improve quality of life, while demonstrating a favorable safety profile in NSCLC patients with qi deficiency and phlegm stasis.
3.Gene Mutation Analysis of an Individual with a RHD Variant RHD*DV.5 and RHD Negative Gene Heterozygote
Shi-Shi WU ; Juan PENG ; Li-Bo WU ; Hong-Xiao CHEN ; Dong-Mei ZHAN ; Yue-Mei DONG ; Wan-Qin WANG ; Liang WU
Journal of Experimental Hematology 2025;33(6):1758-1764
Objective:To perform RHD gene detection on a blood sample with serological weak D phenotype.Methods:A specimen received by the People's Hospital of Zhijin County was serologically identified by the microcolumn gel method and saline method.RHD gene detection was conducted by the PCR-SSP method,and the full sequence determination of the 10 exons amplified was performed.The sequencing results were compared with the ISBT database to determine the genotype.Bioinformatics tool was used to predict the functional damage of mutant proteins,and Alphafold-3 was used for tertiary structural modeling of wild-type and mutant RhD proteins,and the structures of the two proteins were compared and analyzed to explore the reasons why mutations lead to weak serological manifestations.Results:The patient's genotype was identified as RHD*DV.5/RHD*01N.01 heterozygote,with the complete deletion of RHD genes on one chromosome,unable to express the D antigen.On the other chromosome,a G>A mutation occurred at the 697th base of the 5th exon,resulting in a partial D phenotype.This mutation causes internal hydrogen bond changes at the 233 position of RhD protein,resulting in a change in the conformation of the protein,affecting binding to the corresponding antibody.Conclusion:The patient is a heterozygous mutant individual with RHD*DV.5/RHD*01N.01,exhibiting a partial D phenotype serologically.This variation is extremely rare and has been scarcely reported globally.
4.Current status of advanced study personnel engaging in hospital-acquired infection control in a three-A hospital
Xing DONG ; Yunxi LIU ; Mingmei DU ; Yanling BAI ; Congjiao ZHAN ; Xiaona ZHANG ; Yun GE ; Zhen ZHANG ; Haixia SUN ; Rong XU ; Junlong YANG ; Xingxing ZHAO ; Hongwu YAO
Chinese Journal of Nosocomiology 2025;35(14):2214-2218
OBJECTIVE To investigate and analyze the current situation and problems of the advanced personnel en-gaging in the hospital-acquired infection control during their training period and explore the existing countermeas-ures and future development.METHODS The literatures regarding to the advanced study in China were retrieved from databases,the subjects of the literatures covered infection control-related advanced study practice,discipline construction,position competence,talent cultivation,scientific research innovation,professional title evaluation,laws,regulations and development plans.From Aug.2024 to Nov.2024,a questionnaire survey and face-to-face interviews were conducted among 36 advanced study personnel from 9 provinces of China who engaged in hos-pital-acquired infection control in the First Medical Center of Chinese PLA General Hospital.Eventually,36 ques-tionnaires were retrieved,all of which were valid with a questionnaire recovery rate of 100.00%.RESULTS Among the 36 advanced study personnel of hospital-acquired infection control,58.33%were medium-grade professional ti-tle;preventive medicine(41.67%),clinical medicine(25.00%)and nursing(16.67%)ranked the top 3 majors.The personnel engaged in the infection control for more than 6 years,and the duration of the advanced study was generally 3 or 6 months.In reality,the personnel faced the choices in terms of the purposes of further education,learning approaches and learning contents.The advanced study personnel also encountered the problems of challenges from promotion,improvement of position competency,integration with clinical training,supervision and practice,as well as physiological,psychological and family pressure.CONCLUSION Aiming at the problems that the advanced study personnel are generally concerned about,such as how to scientifically and effectively carry out hospital-acquired infection control advanced study and preset and solve the problems that may encounter,it is necessary to formulate targeted training programmes so as to provide bases and enlightenment for establishment of a long-term mechanism for advanced study of infection control in China.
5.Clinicopathological characteristics and prognosis of pancreatic cancer patients with fatty pancreas
Peng DONG ; Qingdi QIN ; Chaoyu PANG ; Zhiyao FAN ; Hanxiang ZHAN
Chinese Journal of Digestive Surgery 2025;24(5):617-622
Objective:To investigate the clinicopathological characteristics and prognosis of pancreatic cancer (PC) patients with fatty pancreas (FP).Methods:The retrospective cohort study was conducted. The clinicopathological data of 116 patients with PC who underwent surgery at Qilu Hospital of Shandong University from January 2013 to January 2022 were collected. There were 85 males and 31 females, aged 60(54,65)years. Observation indicators: (1) clinicopathological characteristics of PC patients with FP; (2) influencing factors for FP in PC patients; (3) prognosis of PC patients with FP. Comparison of count data between groups was conducted using the Pearson chi-square test. Multivariate analysis was conducted using the Logistic regression model. The Kaplan-Meier method was used to plot survival curve and calculate survival rate, and Cox proportional hazard model was used for survival analysis.Results:(1) Clinicopathological characteristics of PC patients with FP. Of the 116 PC patients, there were 43 cases with FP and 73 cases without FP. Cases with tumor location at pancreatic head were 36 in PC patients with FP and 46 in PC patients without FP. Cases with tumor location at pancreatic body or tail were 7 in PC patients with FP and 27 in PC patients without FP. Cases with high-density lipoprotein cholesterol ≥1.04 mmol/L were 14 in PC patients with FP and 34 in PC patients without FP. Cases with dyslipidemia were 33 in PC patients with FP and 36 in PC patients without FP. There were significant differences in tumor location, high-density lipoprotein cholesterol and plasma lipid between PC patients with and without FP ( χ2=5.600, 4.588, 5.165, P<0.05). (2) Influencing factors for FP in PC patients. Results of multivariate analysis showed that no correlation was found between tumor location, high-density lipoprotein cholesterol, plasma lipid and FP in PC patients ( P>0.05). (3) Prognosis of PC patients with FP. Eighty of the 116 PC patients were followed up for 30.8(15.1,57.5)months, with the median overall survival time of 24.0 months. Among them, 54 patients with FP had a median overall survival time of 19.5 months, 26 patients without FP had a median overall survival time of 24.6 months, showing no significant difference in survival between them ( hazard ratio=1.031, P>0.05). Conclusions:There are differ-ences in tumor location, high-density lipoprotein cholesterol and plasma lipid between PC patients with and without FP, but no correlation is found between the above indicators and FP in PC patients. There is no significant difference in prognosis between patients with and without FP.
6.Application and evaluation of scenario simulation combined with standardized patient in the training of doctor-patient communication skills among interns
Nüwa JIN ; Liang CHEN ; Dong ZHOU ; Tianjiao LIU ; Guanyou ZHANG ; Shuhua YANG ; Hanxiang ZHAN
Chinese Journal of Medical Education Research 2025;24(10):1379-1385
Objective:To investigate the application value of scenario simulation combined with standardized patient teaching in the training of doctor-patient communication skills among interns.Methods:A total of 110 clinical medicine interns were selected from Qilu Hospital of Shandong University and were divided into experimental group and control group using a random number table, with 55 interns in each group. The interns in the control group received traditional lecturing, and those in the experimental group received scenario simulation combined with standardized patient case-based teaching. The SEGUE Communication Skill Evaluation Scale and Patient Satisfaction Questionnaire were used to assess the improvement in communication skills in both groups, and Physician Self-Evaluation Scale and Course Satisfaction Questionnaire were used to assess the effectiveness of the course and the degree of satisfaction with the course. SPSS 26.0 was used for the t-test, the Mann-Whitney U test, and the rank sum test. Results:After training, both groups showed significant improvements in communication skills and patient satisfaction [experimental group in terms of communication skills: (55.38±13.11) vs. (74.82±6.75), P<0.001; experimental group in terms of patient satisfaction: 39.00 (39.00, 42.00) vs. 81.00 (79.00, 83.00), P<0.01; control group in terms of communication skills: (56.53±12.34) vs. (65.45±10.18), P<0.001; control group in terms of patient satisfaction: 39.00 (39.00, 42.00) vs. 73.00 (68.00, 77.00), P<0.001], and the experimental group had significantly higher scores than the control group [communication skills: (74.82±6.75) vs. (65.45±10.18), P<0.001; patient satisfaction: 81.00 (79.00, 83.00) vs. 73.00 (68.00, 77.00), P<0.001]. The Physician Self-Evaluation Scale showed that the experimental group had a significant improvement compared with the control group ( P<0.05). The results of the Course Satisfaction Questionnaire showed that the degree of overall satisfaction of the course was only 87.28% in the control group, while all the interns in the experimental group were satisfied with the course ( P<0.001); the new teaching method showed great advantages ( P<0.001). Conclusions:In the training of doctor-patient communication skills among interns, the application of scenario simulation combined with standardized patient case-based teaching can significantly improve their abilities of the application of knowledge application, humanistic concern, and communication skills, and therefore, it is an effective and promising method for the training of doctor-patient communication skills.
7.Current status of advanced study personnel engaging in hospital-acquired infection control in a three-A hospital
Xing DONG ; Yunxi LIU ; Mingmei DU ; Yanling BAI ; Congjiao ZHAN ; Xiaona ZHANG ; Yun GE ; Zhen ZHANG ; Haixia SUN ; Rong XU ; Junlong YANG ; Xingxing ZHAO ; Hongwu YAO
Chinese Journal of Nosocomiology 2025;35(14):2214-2218
OBJECTIVE To investigate and analyze the current situation and problems of the advanced personnel en-gaging in the hospital-acquired infection control during their training period and explore the existing countermeas-ures and future development.METHODS The literatures regarding to the advanced study in China were retrieved from databases,the subjects of the literatures covered infection control-related advanced study practice,discipline construction,position competence,talent cultivation,scientific research innovation,professional title evaluation,laws,regulations and development plans.From Aug.2024 to Nov.2024,a questionnaire survey and face-to-face interviews were conducted among 36 advanced study personnel from 9 provinces of China who engaged in hos-pital-acquired infection control in the First Medical Center of Chinese PLA General Hospital.Eventually,36 ques-tionnaires were retrieved,all of which were valid with a questionnaire recovery rate of 100.00%.RESULTS Among the 36 advanced study personnel of hospital-acquired infection control,58.33%were medium-grade professional ti-tle;preventive medicine(41.67%),clinical medicine(25.00%)and nursing(16.67%)ranked the top 3 majors.The personnel engaged in the infection control for more than 6 years,and the duration of the advanced study was generally 3 or 6 months.In reality,the personnel faced the choices in terms of the purposes of further education,learning approaches and learning contents.The advanced study personnel also encountered the problems of challenges from promotion,improvement of position competency,integration with clinical training,supervision and practice,as well as physiological,psychological and family pressure.CONCLUSION Aiming at the problems that the advanced study personnel are generally concerned about,such as how to scientifically and effectively carry out hospital-acquired infection control advanced study and preset and solve the problems that may encounter,it is necessary to formulate targeted training programmes so as to provide bases and enlightenment for establishment of a long-term mechanism for advanced study of infection control in China.
8.Application and evaluation of scenario simulation combined with standardized patient in the training of doctor-patient communication skills among interns
Nüwa JIN ; Liang CHEN ; Dong ZHOU ; Tianjiao LIU ; Guanyou ZHANG ; Shuhua YANG ; Hanxiang ZHAN
Chinese Journal of Medical Education Research 2025;24(10):1379-1385
Objective:To investigate the application value of scenario simulation combined with standardized patient teaching in the training of doctor-patient communication skills among interns.Methods:A total of 110 clinical medicine interns were selected from Qilu Hospital of Shandong University and were divided into experimental group and control group using a random number table, with 55 interns in each group. The interns in the control group received traditional lecturing, and those in the experimental group received scenario simulation combined with standardized patient case-based teaching. The SEGUE Communication Skill Evaluation Scale and Patient Satisfaction Questionnaire were used to assess the improvement in communication skills in both groups, and Physician Self-Evaluation Scale and Course Satisfaction Questionnaire were used to assess the effectiveness of the course and the degree of satisfaction with the course. SPSS 26.0 was used for the t-test, the Mann-Whitney U test, and the rank sum test. Results:After training, both groups showed significant improvements in communication skills and patient satisfaction [experimental group in terms of communication skills: (55.38±13.11) vs. (74.82±6.75), P<0.001; experimental group in terms of patient satisfaction: 39.00 (39.00, 42.00) vs. 81.00 (79.00, 83.00), P<0.01; control group in terms of communication skills: (56.53±12.34) vs. (65.45±10.18), P<0.001; control group in terms of patient satisfaction: 39.00 (39.00, 42.00) vs. 73.00 (68.00, 77.00), P<0.001], and the experimental group had significantly higher scores than the control group [communication skills: (74.82±6.75) vs. (65.45±10.18), P<0.001; patient satisfaction: 81.00 (79.00, 83.00) vs. 73.00 (68.00, 77.00), P<0.001]. The Physician Self-Evaluation Scale showed that the experimental group had a significant improvement compared with the control group ( P<0.05). The results of the Course Satisfaction Questionnaire showed that the degree of overall satisfaction of the course was only 87.28% in the control group, while all the interns in the experimental group were satisfied with the course ( P<0.001); the new teaching method showed great advantages ( P<0.001). Conclusions:In the training of doctor-patient communication skills among interns, the application of scenario simulation combined with standardized patient case-based teaching can significantly improve their abilities of the application of knowledge application, humanistic concern, and communication skills, and therefore, it is an effective and promising method for the training of doctor-patient communication skills.
9.Effects of high-fat diet intake on pharmacokinetics of rabeprazole sodium enteric-coated tablets in healthy Chinese subjects
Cai-hui GUO ; Yu-fang XU ; Cong-yang DING ; Guang-tao HAO ; Hao-jing SONG ; Xue SUN ; Zhan-jun DONG ; Wan-jun BAI
The Chinese Journal of Clinical Pharmacology 2025;41(2):225-229
Objective To evaluate the effects of fasting and high-fat diet on the pharmacokinetics of rabeprazole sodium enteric-coated tablets in healthy Chinese subjects.Methods A single-center,randomized,open,two-agent,two-sequence,four-cycle,fully repeated crossover,single-dose trial design was used in this study,healthy subjects were assigned to receive single dose of rabeprazole sodium enteric-coated tablets 0.1 g in either fasting or high-fat diet state,and blood samples were taken at different time points,respectively.The concentrations of rabeprazole sodium enteric-coated in plasma were determined by liquid chromatography-tandem mass spectrometry(LC-MS/MS),the model method of the non-compartmental was used to calculate the pharmacokinetic parameters by Phoenix WinNonlin 8.2.Results The main pharmacokinetic parameters of rabeprazole sodium enteric-coated tablets in fasting state and high-fat diet state were as follows:Cmax were(339.63±156.47)and(318.86±132.13)ng·mL-1;t1/2 were(2.34±0.68)and(3.60±2.40)h;AUC0_t were(556.62±251.65)and(528.50±201.78)ng·mL-1·h;AUC0-∞ were(563.39±255.69)and(535.15±203.24)ng·mL-1·h;tmax were 3.65 and 6.99 h.After high-fat diet,the Cmax and AUC of rapeprazole sodium after high-fat and high-calorie diet decreased,Cmax decreased by 6.12%,AUC0-t decreased by 5.05%,AUC0-∞ decreased by 5.01%,andtmaxwas delayed by about 3.34 h.Cmax,AUC0-t and AUC0-∞ 90%confidence interval were 73.13%-115.10%,83.22%-112.28%and 83.40%-112.13%,respectively.Neither was between 85.00%-125.00%.Conclusion High-fat diet affects the absorption rate and degree of rabeprazole sodium enteric-coated,so it is suitable to be administered on an empty stomach.
10.Determination of sotagliflozin in rat plasma by UPLC-MS/MS method
Ge-xi CAO ; Xiao-xu ZHANG ; Yan-ru DENG ; Bin YAN ; Zhan-jun DONG
The Chinese Journal of Clinical Pharmacology 2025;41(2):230-234
Objective To establish a ultra-high performance liquid chromatography-tandem mass spectrometer(UPLC-MS/MS)method for determining the concentration of sotagliflozin in rat plasma and apply it to pharmacokinetic studies in rats.Methods Electrospray negative ion multi-reaction ion detection was used.Chromatographic column:EXT-C18(2.1 mm × 100.0 mm,2.7 μm);column temperature:45 ℃;mobile phase:5 mmol·L-1 ammonium acetate aqueous solution-acetonitrile;flow rate:0.35 mL·min-1;ion pairs:sotagliflozin m/z 483.3→315.1,dapagliflozin m/z 467.4→329.2;injection volume:6 μL,plasma samples were processed using methyl tert-butyl ether liquid-liquid extraction.Six male SD rats were administered a single oral dose of sogliflozin at 40 mg·kg-1,and detected the concentration of sogliflozin in plasma.Pharmacokinetic parameters were calculated using Drug And Statistics(DAS)2.1.1.Results Sotagliflozin showed good linearity within the range of 5-2 000 ng·mL-1,with intra-day and inter-day precision both less than 15%.The recovery rate,matrix effect,and stability were all within the specified range.Pharmacokinetic parameters:Cmax was(3 716.67±568.28)ng·mL-1,tmax was(1.00±0.32)h,t1/2 was(2.28±0.45)h,AUC0-t was(1.70 × 104±2 075.87)ng·mL-1·h.Conclusion This study established a method for determining the concentration of sotagliflozin in rat plasma,which is characterized by high sensitivity,rapid detection,and good repeatability.It is suitable for the determination of sotagliflozin concentration in plasma and pharmacokinetic studies.

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