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.Reporting Guidelines in Implementation Science:Overview,Categorization and Future Directions
Xiaoshan CHEN ; Dadong WU ; Run WANG ; Qing ZHAO ; Siyuan LIU ; Wanqing HUANG ; Zizhen HUANG ; Yuting WAN ; Huanyu HU ; Junlin ZHU ; Jiangyun CHEN ; Zhiwei HUANG ; Dong XU
Medical Journal of Peking Union Medical College Hospital 2025;16(4):1033-1046
Reporting guidelines are structured checklists for researchers to follow when reporting spe-cific types of studies.As researches conducted in real-world settings to address practical issues,implementa-tion research has stringent requirements for the replicability of result and the transparency of reporting,making its reporting guidelines particularly important.This paper systematically introduces the reporting guidelines in the field of implementation science,outlines their classification systems and scopes of applica-tion,and focuses on explaining the core characteristics and functions of five key reporting guidelines,inclu-ding the Standards for Reporting Implementation Studies(StaRI),Reporting guidelines for implementation and operational research,the Template for Intervention Description and Replication(TIDieR),the Frame-work for Reporting Adaptations and Modifications-Enhanced(FRAME),and recommendations for specifying and reporting implementation strategies.Furthermore,combined with the PEDALs research paradigm in im-plementation science,this paper further clarifies the specific application pathways for reporting guidelines and discusses directions for refinement,aiming to provide references for researchers to select appropriate reporting guidelines.
3.Immunomodulatory effect and survival benefit of albumin-bound Paclitaxel combined with Sintilimab in advanced esophageal cancer
Jiangyun ZHOU ; Yuan YUAN ; Meiyun DAI ; Yingying WU ; Jiayu LIU
Immunological Journal 2025;41(11):835-841
Objective To investigate the immunomodulatory effect of albumin-bound Paclitaxel combined with Sintilimab on advanced esophageal cancer,and to analyze the survival benefit.Methods A total of 126 patients with advanced esophageal cancer admitted to Rugao People's Hospital from March 2020 to March 2023 were selected,and divided into the observation group(n=63)and the control group(n=63)using a random number table method.The control group was given albumin-bound Paclitaxel,while the observation group was given albumin-bound Paclitaxel combined with Sintilimab.The clinical efficacy,tumor markers[cytokeratin 19 fragment(CYFRA21-1),squamous cell carcinoma antigen(SCC-Ag),carbohydrate antigen 125(CA125),carcinoembryonic antigen(CEA)],immune function indicators(Th1/Th2,Th17/Treg),PD-1/PD-L1 signaling pathway indicators,Karnofsky performance status(KPS)scores,overall survival,and toxic side effects were compared between the two groups.Results The objective remission rate[38.10%(24/63)]and disease control rate[87.30%(55/63)]of the observation group were higher than those of the control group[20.63%(13/63),71.43%(45/63)](P<0.05).After 2 and 4 cycles of treatment,the serum SCC-Ag,CYFRA21-1,CA125 and CEA in the observation group were lower than those in the control group(P<0.05);after 2 and 4 cycles of treatment,compared with the control group,the observation group showed higher Th1/Th2,and lower Th17/Treg,PD-1 and PD-L1(P<0.05).The improvement rate of quality of life,progression free survival and overall survival in the observation group were higher or longer than those in the control group(P<0.05).There was no significant difference in the incidence of abnormal liver dysfunction,nausea and vomiting,decreased hemoglobin and leucopenia between the two groups(P>0.05),but the incidence of rash in the observation group[57.14%(36/63)]was higher than that in the control group[34.92%(22/63)](P<0.05).Conclusion Combination therapy of Sintilimab and albumin-bound Paclitaxel shows significant efficacy in the treatment of advanced esophageal cancer.It can regulate serum tumor marker levels,improve immune function,reduce the activity of the PD-1/PD-L1 signaling pathway to inhibit disease progression,enhance survival benefits,and improve quality of life.However,attention should be paid to the observation of rash reactions during treatment.
4.Reporting Guidelines in Implementation Science:Overview,Categorization and Future Directions
Xiaoshan CHEN ; Dadong WU ; Run WANG ; Qing ZHAO ; Siyuan LIU ; Wanqing HUANG ; Zizhen HUANG ; Yuting WAN ; Huanyu HU ; Junlin ZHU ; Jiangyun CHEN ; Zhiwei HUANG ; Dong XU
Medical Journal of Peking Union Medical College Hospital 2025;16(4):1033-1046
Reporting guidelines are structured checklists for researchers to follow when reporting spe-cific types of studies.As researches conducted in real-world settings to address practical issues,implementa-tion research has stringent requirements for the replicability of result and the transparency of reporting,making its reporting guidelines particularly important.This paper systematically introduces the reporting guidelines in the field of implementation science,outlines their classification systems and scopes of applica-tion,and focuses on explaining the core characteristics and functions of five key reporting guidelines,inclu-ding the Standards for Reporting Implementation Studies(StaRI),Reporting guidelines for implementation and operational research,the Template for Intervention Description and Replication(TIDieR),the Frame-work for Reporting Adaptations and Modifications-Enhanced(FRAME),and recommendations for specifying and reporting implementation strategies.Furthermore,combined with the PEDALs research paradigm in im-plementation science,this paper further clarifies the specific application pathways for reporting guidelines and discusses directions for refinement,aiming to provide references for researchers to select appropriate reporting guidelines.
5.Immunomodulatory effect and survival benefit of albumin-bound Paclitaxel combined with Sintilimab in advanced esophageal cancer
Jiangyun ZHOU ; Yuan YUAN ; Meiyun DAI ; Yingying WU ; Jiayu LIU
Immunological Journal 2025;41(11):835-841
Objective To investigate the immunomodulatory effect of albumin-bound Paclitaxel combined with Sintilimab on advanced esophageal cancer,and to analyze the survival benefit.Methods A total of 126 patients with advanced esophageal cancer admitted to Rugao People's Hospital from March 2020 to March 2023 were selected,and divided into the observation group(n=63)and the control group(n=63)using a random number table method.The control group was given albumin-bound Paclitaxel,while the observation group was given albumin-bound Paclitaxel combined with Sintilimab.The clinical efficacy,tumor markers[cytokeratin 19 fragment(CYFRA21-1),squamous cell carcinoma antigen(SCC-Ag),carbohydrate antigen 125(CA125),carcinoembryonic antigen(CEA)],immune function indicators(Th1/Th2,Th17/Treg),PD-1/PD-L1 signaling pathway indicators,Karnofsky performance status(KPS)scores,overall survival,and toxic side effects were compared between the two groups.Results The objective remission rate[38.10%(24/63)]and disease control rate[87.30%(55/63)]of the observation group were higher than those of the control group[20.63%(13/63),71.43%(45/63)](P<0.05).After 2 and 4 cycles of treatment,the serum SCC-Ag,CYFRA21-1,CA125 and CEA in the observation group were lower than those in the control group(P<0.05);after 2 and 4 cycles of treatment,compared with the control group,the observation group showed higher Th1/Th2,and lower Th17/Treg,PD-1 and PD-L1(P<0.05).The improvement rate of quality of life,progression free survival and overall survival in the observation group were higher or longer than those in the control group(P<0.05).There was no significant difference in the incidence of abnormal liver dysfunction,nausea and vomiting,decreased hemoglobin and leucopenia between the two groups(P>0.05),but the incidence of rash in the observation group[57.14%(36/63)]was higher than that in the control group[34.92%(22/63)](P<0.05).Conclusion Combination therapy of Sintilimab and albumin-bound Paclitaxel shows significant efficacy in the treatment of advanced esophageal cancer.It can regulate serum tumor marker levels,improve immune function,reduce the activity of the PD-1/PD-L1 signaling pathway to inhibit disease progression,enhance survival benefits,and improve quality of life.However,attention should be paid to the observation of rash reactions during treatment.
6.Exploring the Mechanism of Jianpi Shenshi Formula for the Treatment of Hyperuricemia Based on Network Pharmacology and Molecular Docking
Qian DENG ; Xingqiang WANG ; Weitian YAN ; Zining PENG ; Nian LIU ; Chunping WAN ; Jiangyun PENG
Traditional Chinese Drug Research & Clinical Pharmacology 2024;35(6):850-861
Objective To investigate the potential mechanism of Jianpi Shenshi Formula for the treatment of hyperuricemia(HUA)by using network pharmacology and molecular docking techniques.Methods The active ingredients of Jianpi Shenshi Formula were searched and screened by combining TCMSP,BATMAN,and TCM-ID database with literature,and then SwissTargetPrediction was used to obtain the corresponding targets of the ingredients.Cytoscape 3.8.0 was used to construct a"drug-ingredients"network to analyze and obtain the main active ingredients of Jianpi Shenshi Formula.The GeneCards,OMIM,and disgenet databases were used to obtain the relevant targets of hyperuricemia.The intersection targets of Jianpi Shenshi Formula and hyperuricemia were imported into the STRING database for protein-protein interaction(PPI)network analysis,and hub targets for network were screened by CytoHubba plug-in.Meanwhile,the GO function and KEGG pathway enrichment analysis of the intersection targets were carried out using R4.2.2 software.Molecular docking of hub targets and key ingredients was performed using CB-DOCK 2.Results A total of 90 active ingredients of Jianpi Shenshi Formula were screened,among which quercetin,kaempferol,luteolin,stigmasterol,and ethyl linoleate were the main active ingredients,and 837 targets corresponding to the ingredients were obtained,with a total of 64 intersecting targets.CASP3,IL1B,IL6,PPARG,SIRT1,MAPK3,TNF,STAT3,TGFβ1,PTGS2,and XDH were the hub targets.The potential targets of action are mainly enriched in signaling pathways such as inflammation,metabolism,environment,cellular processes,biological systems,and hyperuricemia-related pathways.Conclusion Jianpi Shenshi Formula may exert effects on inhibition of uric acid production,and/or enhancement of uric acid excretion,anti-inflammation,and amelioration of related complications through the modulation of hyperuricemia-related signaling pathways(including neoplastic,infectious,metabolic,and cardiovascular diseases),as well as metabolic,immune,inflammatory,and other biological pathways by a variety of active ingredients such as quercetin,kaempferol,luteolin,stigmasterol,and ethyl linoleate.
7.A Method for Developing Implementation Strategies to Address Implementation Barriers: the CFIR-ERIC Matching Tool
Wanqing HUANG ; Dongmei ZHONG ; Siyuan LIU ; Yunyun XIE ; Jiangyun CHEN ; Dong XU
Medical Journal of Peking Union Medical College Hospital 2024;15(5):1182-1191
Implementation strategies are targeted interventions aimed at promoting the adoption, implementation, and sustainment of research findings or evidence-based practices in routine healthcare. If implementation strategies can precisely match implementation barriers and facilitators, the likelihood of successful implementation will increase. The CFIR-ERIC matching tool, which can match corresponding ERIC implementation strategies based on CFIR barriers, is a convenient and direct tool for developing implementation strategies. This paper provides a detailed overview of the origins and development of the CFIR-ERIC matching tool, outlines its contents and usage, and illustrates how to apply the tool to develop implementation strategies by using a brief smoking cessation intervention project as an example. The paper also discusses the advantages and limitations of using this tool for developing implementation strategies, with the aim of providing methodological reference for other researchers.
8.Epidemiological characteristics of dengue fever in Mengla County, Yunnan Province in 2019
Jiao WANG ; Jiangyun LIU ; Qi MAO ; Shimei CHEN ; Guomin HE
Shanghai Journal of Preventive Medicine 2022;34(6):555-558
ObjectiveTo analyze the epidemic characteristics of dengue fever in Mengla County and provide basis for scientific prevention and control of dengue fever. MethodsWe collected the case information of dengue fever in Mengla County reported by the infectious disease reporting information system of China Center for Disease Control and prevention from January 1 to December 31, 2019 and the case field investigation records. The case data were analyzed by descriptive epidemiological method. ResultsIn 2019, Mengla County reported 369 cases of dengue fever, all of which were unclassified, including 354 clinically diagnosed cases, 15 confirmed cases, 6 severe cases, and there was no deaths. The annual incidence rate was 120.98/105. Mengla Town had the most cases (145 cases, 39.30%) followed by 63 cases (17.07%) in Mengpeng Town. The reported cases were mainly local cases (65.85%). The ratio of male to female was 1.25∶1. The age distribution was mainly in the group of 21‒60 years old (82.38%). Farmers (112 cases, 30.35%) and business service providers (85 cases, 23.04%) were the majority. The annual cases were distributed from May to November, of which the most were reported in September, and the number of cases reported from July to October accounts for 93.22% of all cases. ConclusionMengla County is still a high incidence area of dengue fever in Yunnan Province, and the vector Aedes is widespread. It is suggested to strengthen mosquito prevention and control in the epidemic season, actively carry out patriotic health campaign, carry out special rectification of the environment in rural areas, and conduct effective public education.
9.Surveillance of Japanese encephalitis related mosquitoes in Mengla County, Yunnan Province
Jiao WANG ; Jiangyun LIU ; Shimei CHEN ; Junming LI ; Guomin HE ; Wulin XU ; Qi MAO
Shanghai Journal of Preventive Medicine 2022;34(8):756-760
ObjectiveTo analyze the epidemic characteristics and trend of mosquito vectors related to Japanese encephalitis (JE) in Mengla County, and to provide scientific evidence for JE prevention and control. MethodsThe JE related mosquito vector monitoring data in Mengla County from 2016 to 2020 were collected and subjected to further statistical analysis. ResultsA total of 1 689 mosquitoes were captured at the JE mosquito vector monitoring sites in Mengla County, 36.3% of which were captured in 2020 and 13.3% in 2017. The density of Culex tritaeniorhynchus was the highest (3.04 per lamp per day), and that of Anopheles sinensis was the lowest (1.03 per lamp per day). The distribution of mosquito species showed significant difference in the same year. The mosquito density in pig house was 12.93 per lamp∙day, and that in human house was 4.67 per lamp∙day. The mosquito density of different mosquito species in pig house was higher than that in human house. There was no significant difference in the site distribution of Anopheles sinensis, but there were significant differences in the site distribution of Culex tritaeniorhynchus, Culex pipiens quinquefasciatus and other mosquito species. The mosquito density peaked in May (12.78 per lamp per day) and July (10.28 per lamp per day). The temporal distribution showed that the vector density decreased gradually from May to October, however, the species population structure also varied significantly, and the trends of each mosquito species also varied greatly. In Mengla, Culex tritaeniorhynchus peaked in May. ConclusionThe JE epidemic situation in Mengla County is still severe. It is recommended to strengthen prevention and control in the peak season of mosquito activities, such as actively carrying out patriotic health campaigns, and effective public education. At the same time, we should also strengthen the JE vaccination for school-age children and the training of medical personnel.
10.Comparing the clinical characteristics and prognosis of seropositive and seronegative rheumatoid arthritis patients in China: a real-world study
Yehua JIN ; Ting JIANG ; Xiaolei FAN ; Rongsheng WANG ; Yuanyuan ZHANG ; Peng CHENG ; Yingying QIN ; Mengjie HONG ; Mengru GUO ; Qingqing CHENG ; Zhaoyi LIU ; Runrun ZHANG ; Cen CHANG ; Lingxia XU ; Linshuai XU ; Ying GU ; Chunrong HU ; Xiao SU ; Luan XUE ; Yongfei FANG ; Li SU ; Mingli GAO ; Jiangyun PENG ; Qianghua WEI ; Jie SHEN ; Qi ZHU ; Hongxia LIU ; Dongyi HE
Chinese Journal of Rheumatology 2021;25(5):307-315
Objective:In general, patients with seropositive rheumatoid arthritis (RA) are considered to show an aggressive disease course. However, the relationship between the two subgroups in disease severity is controversial. Our study is aimed to compare the clinical characteristics and prognosis of double-seropositive and seronegative RA in China through a real-world large scale study.Methods:RA patients who met the 1987 American College of Rheumatology (ACR) classification criteria or the 2010 ACR/European Anti-Rheumatism Alliance RA classification criteria, and who attended the 10 hospitals across the country from September 2015 to January 2020, were enrolled. According to the serological status, patients were divided into 4 subgroups [rheumatoid factor (RF)(-) anti-cyclic citrullinated peptide (CCP) antibody (-), RF(+), RF(+) anti-CCP antibody(+), anti-CCP antibody(+)] and compared the disease characteristics and treatment response. One-way analysis of variance was used for measurement data that conformed to normal distribution, Kruskal-Wallis H test was used for measurement data that did not conform to normal distribution; paired t test was used for comparison before and after treatment within the group if the data was normally distributed else paired rank sum test was used; χ2 test was used for count data. Results:① A total of 2 461 patients were included, including 1 813 RF(+) anti-CCP antibody(+) patients (73.67%), 129 RF(+) patients (5.24%), 245 RF(-) anti-CCP antibody(-) patients (9.96%), 74 anti-CCP antibody(+) patients (11.13%). ② Regardless of the CCP status, RF(+) patients had an early age of onset [RF(-) anti-CCP antibody(-) (51±14) years old, anti-CCP antibody(+) (50±15) years old, RF(+) anti-CCP antibody(+) (48±14) years old, RF(+)(48±13) years old, F=3.003, P=0.029], longer disease duration [RF(-) anti-CCP antibody(-) 50 (20, 126) months, anti-CCP antibody(+) 60(24, 150) months, RF(+) anti-CCP antibody(+) 89(35, 179) months, RF(+) 83(25, 160) months, H=22.001, P<0.01], more joint swelling counts (SJC) [RF(-) anti-CCP antibody(-) 2(0, 6), Anti-CCP antibody(+) 2(0, 5), RF(+) anti-CCP antibody(+) 2(0, 7), RF(+) 2(0, 6), H=8.939, P=0.03] and tender joint counts (TJC) [RF(-) anti-CCP antibody(-) 3(0, 8), anti-CCP antibody(+) 2(0, 6), RF(+) anti-CCP antibody(+) 3(1, 9), RF(+) 2(0, 8), H=11.341, P=0.01] and the morning stiff time was longer [RF(-) anti-CCP antibody(-) 30(0, 60) min, anti-CCP antibody(+) 20(0, 60) min, RF(+) anti-CCP antibody(+) 30(10, 60) min, RF(+) 30(10, 60) min, H=13.32, P<0.01]; ESR [RF(-) anti-CCP antibody(-) 17(9, 38) mm/1 h, anti-CCP antibody(+) 20(10, 35) mm/1 h, RF(+) anti-CCP antibody(+) 26(14, 45) mm/1 h, RF(+) 28(14, 50) mm/1 h, H=37.084, P<0.01] and CRP [RF(-) anti-CCP antibody(-) 2.3 (0.8, 15.9) mm/L, Anti-CCP antibody(+) 2.7(0.7, 12.1) mm/L, RF(+) anti-CCP antibody(+) 5.2(1.3, 17.2) mm/L, RF (+) 5.2(0.9, 16.2) mm/L, H=22.141, P<0.01] of the RF(+)patients were significantly higher than RF(-) patients, and RF(+) patients had higher disease severity(DAS28-ESR) [RF(-) anti-CCP antibody(-) (4.0±1.8), anti-CCP antibody(+) (3.8±1.6), RF(+) anti-CCP antibody(+) (4.3±1.8), RF(+) (4.1±1.7), F=7.269, P<0.01]. ③ The RF(+) anti-CCP antibody(+) patients were divided into 4 subgroups, and it was found that RF-H anti-CCP antibody-L patients had higher disease severity [RF-H anti-CCP antibody-H 4.3(2.9, 5.6), RF-L anti-CCP antibody-L 4.5(3.0, 5.7), RF-H anti-CCP antibody-L 4.9(3.1, 6.2), RF-L anti-CCP antibody-H 2.8(1.8, 3.9), H=20.374, P<0.01]. ④ After 3-month follow up, the clinical characteristics of the four groups were improved, but there was no significant difference in the improvement of the four groups, indicating that the RF and anti-CCP antibody status did not affect the remission within 3 months. Conclusion:Among RA patients, the disease activity of RA patients is closely related to RF and the RF(+) patients have more severe disease than RF(-) patients. Patients with higher RF titer also have more severe disease than that of patients with low RF titer. After 3 months of medication treatment, the antibody status does not affect the disease remission rate.

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