1.Reporting Status of Clinical Practice Guideline Protocols: A Systematic Analysis
Huayu ZHANG ; Xufei LUO ; Hui LIU ; Qi ZHOU ; Yishan QIN ; Ye WANG ; Yuanyuan YAO ; Haodong LI ; Xiaohui WANG ; Yaolong CHEN
Medical Journal of Peking Union Medical College Hospital 2026;17(1):255-262
To systematically analyzed the reporting status of core elements in publicly available clinical practice guideline(hereafter referred to as "guideline") protocols published domestically and internationally over the past decade, identified existing problems, and provided evidence to inform the standardized writing and publication of future guideline protocols. A systematic search was conducted in Chinese and English databases for clinical practice guideline protocols published during the past ten years. The basic characteristics and reporting of core elements—including registration information, conflict of interest management, evidence grading, development process and timeline planning, as well as dissemination and implementation—were extracted and analyzed. Chi-square tests were performed to explore associations between protocol characteristics and the reporting of core elements. A total of 94 guideline protocols were included, of which 67 were in Chinese(71.28%) and 27 were in English(28.72%). Overall, 82.98% of the guideline protocols were registered, 92.55% reported management of conflicts of interest, 97.87% reported evidence searching, 88.30% reported evidence grading, and 89.36% described dissemination and implementation strategies. However, only 55.32% reported the guideline development process, and merely 23.40% reported timeline planning. Further analysis indicated that the reporting of registration, evidence searching, development process, and timeline planning was associated with year of publication. Differences were observed between domestic and international guidelines in reporting registration, conflict of interest management, development process, time planning, and dissemination and implementation. Guidelines intended for development exhibited higher reporting rates for registration, development process, and dissemination and implementation compared to those planned for updating or adaptation. Although current guideline protocols demonstrate relatively adequate reporting of methodological elements, deficiencies remain in development process and timeline planning. Future efforts should focus on promoting the publication and standardized reporting of guideline protocols, enhancing the international recognition of registration platforms, and strengthening the development process and timeline planning to advance the scientific rigor and transparency of guideline development.
2.Interpretation on the ACcurate COnsensus Reporting Document (ACCORD): Reporting Guidelines for Consensus Methods in Biomedical Research
Haodong LI ; Junxian ZHAO ; Yishan QIN ; Ye WANG ; Huayu ZHANG ; Qi ZHOU ; Yaolong CHEN
Medical Journal of Peking Union Medical College Hospital 2026;17(2):534-545
The importance of consensus research in medical decision-making has become increasinglyprominent. However, this field has long lacked unified terminology definitions and reporting standards, leading to significant heterogeneity in study design, implementation, and result presentation that affects the credibility and reproducibility of outcomes. The ACCurate COnsensus Reporting Document (ACCORD) in the field of biomedical research provides a structured writing framework for various consensus methods such as the Delphi method and nominal group technique, aiming to enhance the completeness and transparency of study reports. Combined with specific cases, this article interprets the core items of ACCORD, offering references for the design, implementation, and reporting of high-quality consensus research in China.
3.An analysis of clinical pharmacist training bases and pharmacist staffing status based on field research
Liang HUANG ; Jiancun ZHEN ; Li YOU ; Jing BIAN ; Yishan BU ; Quanzhi LI ; Zining WANG ; Xiaofen YE ; Ping ZHENG ; Rui YANG ; Jun YANG ; Yangui XU ; Jin LU
China Pharmacy 2026;37(13):1661-1666
OBJECTIVE To clarify the current development status of clinical pharmacist training bases and the pharmacist workforce in China, and to provide evidence for standardizing base construction and promoting the high-quality development of hospital pharmacy. METHODS Questionnaires were distributed to all clinical pharmacist training bases for urgently-needed health professionals and clinical pharmacist training bases under the Chinese Hospital Association that had been approved by the end of 2023 to collect data including base profiles and pharmacist staffing conditions. Expert teams carried out field investigations to verify the collected data. Descriptive statistical analyses were conducted on the quantity, type and regional distribution of training bases, and the influencing factors of pharmacist staffing in the bases were analyzed. RESULTS Field surveys were completed covering 297 training bases across 31 provincial-level administrative regions. Among the base hospitals, 87.88% were Grade A tertiary general hospitals, and 65.32% were located in provincial capitals. The eastern region had the largest number of bases (136, accounting for 45.79%), followed by the western region (79, 26.60%). Great disparities existed among provinces in terms of base quantity and hospital scale. The median proportion of pharmaceutical technical personnel in base hospitals was 4.05%, and the median number of clinical pharmacists per 100 hospital beds was 0.53. Both indicators reached the highest in the eastern region (0.57, 4.43%) and the lowest in the northeastern region (0.45, 3.01%). A total of 3 627 full-time clinical pharmacists were employed in all surveyed bases, among whom 83.68% held clinical pharmacist training certificates, 35.43% possessed senior professional titles, and 78.19% had postgraduate or higher educational background. The total annual training capacity of the surveyed bases was 4 291 trainees, with obvious differences in annual training capacity across regions and provinces. Training specialties covered 19 specialized disciplines plus one general discipline, and no province could deliver training for all 20 specialties simultaneously. Multivariate Logistic regression analysis showed that geographic region exerte d a significant impact on the proportion of pharmaceutical technical personnel (≥4%) ( P <0.05), while the approval time of training bases and hospital scale had significant effects on the number of clinical pharmacists per 100 beds (≥0.6) ( P <0.05). CONCLUSIONS China’s clinical pharmacist training system has basically matured and taken initial shape. The distribution of clinical pharmacist training resources is generally consistent with regional population and economic development levels. However, the allocation of pharmaceutical staff and clinical pharmacists has not yet met national standards and clinical service demands.
4.An analysis of clinical pharmacist training bases and pharmacist staffing status based on field research
Liang HUANG ; Jiancun ZHEN ; Li YOU ; Jing BIAN ; Yishan BU ; Quanzhi LI ; Zining WANG ; Xiaofen YE ; Ping ZHENG ; Rui YANG ; Jun YANG ; Yangui XU ; Jin LU
China Pharmacy 2026;37(13):1661-1666
OBJECTIVE To clarify the current development status of clinical pharmacist training bases and the pharmacist workforce in China, and to provide evidence for standardizing base construction and promoting the high-quality development of hospital pharmacy. METHODS Questionnaires were distributed to all clinical pharmacist training bases for urgently-needed health professionals and clinical pharmacist training bases under the Chinese Hospital Association that had been approved by the end of 2023 to collect data including base profiles and pharmacist staffing conditions. Expert teams carried out field investigations to verify the collected data. Descriptive statistical analyses were conducted on the quantity, type and regional distribution of training bases, and the influencing factors of pharmacist staffing in the bases were analyzed. RESULTS Field surveys were completed covering 297 training bases across 31 provincial-level administrative regions. Among the base hospitals, 87.88% were Grade A tertiary general hospitals, and 65.32% were located in provincial capitals. The eastern region had the largest number of bases (136, accounting for 45.79%), followed by the western region (79, 26.60%). Great disparities existed among provinces in terms of base quantity and hospital scale. The median proportion of pharmaceutical technical personnel in base hospitals was 4.05%, and the median number of clinical pharmacists per 100 hospital beds was 0.53. Both indicators reached the highest in the eastern region (0.57, 4.43%) and the lowest in the northeastern region (0.45, 3.01%). A total of 3 627 full-time clinical pharmacists were employed in all surveyed bases, among whom 83.68% held clinical pharmacist training certificates, 35.43% possessed senior professional titles, and 78.19% had postgraduate or higher educational background. The total annual training capacity of the surveyed bases was 4 291 trainees, with obvious differences in annual training capacity across regions and provinces. Training specialties covered 19 specialized disciplines plus one general discipline, and no province could deliver training for all 20 specialties simultaneously. Multivariate Logistic regression analysis showed that geographic region exerte d a significant impact on the proportion of pharmaceutical technical personnel (≥4%) ( P <0.05), while the approval time of training bases and hospital scale had significant effects on the number of clinical pharmacists per 100 beds (≥0.6) ( P <0.05). CONCLUSIONS China’s clinical pharmacist training system has basically matured and taken initial shape. The distribution of clinical pharmacist training resources is generally consistent with regional population and economic development levels. However, the allocation of pharmaceutical staff and clinical pharmacists has not yet met national standards and clinical service demands.
5.Study on the current status of quality management of clinical pharmacist training bases in China
Ping ZHENG ; Jiancun ZHEN ; Li YOU ; Yangui XU ; Liang HUANG ; Jing BIAN ; Jin LU ; Yishan BU ; Quanzhi LI ; Zining WANG ; Xiaofen YE ; Jun YANG ; Rui YANG
China Pharmacy 2026;37(14):1826-1831
OBJECTIVE To investigate the current status of quality management in clinical pharmacist training bases in China, and to provide references for the standardized development and improvement of these bases. METHODS A combined approach of questionnaire survey and on-site investigation was adopted, targeting the healthcare highly sought-after talent (clinical pharmacist) training bases in 31 provinces of China as well as the clinical pharmacist training bases affiliated with the Chinese Hospital Association. A training quality management evaluation index system consisting of 25 tertiary indicators was established. Investigations were conducted from two dimensions: structural quality of training and quality management of training processes. Data were statistically analyzed using descriptive statistical methods. RESULTS On-site investigations were completed for 297 clinical pharmacist training bases across the 31 provinces, among which 284 were affiliated with the Chinese Hospital Association and 271 were healthcare highly sought-after talent (clinical pharmacist) training bases. In terms of structural quality, the core indicator compliance rate for hospital-level training systems exceeded 80%, the rate of special fund utilization for designated purposes reached 80.13%, and the overall compliance rate for software and hardware facilities surpassed 88%. A total of 1 348 preceptors were employed across the training bases, among whom those with senior professional titles and full-time specialist clinical pharmacists as lead preceptors accounted for 62.91% and 94.36%, respectively. Regarding process quality, the compliance rate for “establishment of clinical practice teaching groups in accordance with regulations during clinical department rotations” was 85.19%, and 79.80% and 76.09% of the bases were found to implement strict confidentiality in theoretical examinations and meet the required scale of assessment cases, respectively. However, formal documents of corresponding training management regulations were formulated in only 57.91% of the bases, and the completeness and standardization rate of training manual completion was merely 47.47%. In addition, considerable disparities in quality management levels were observed among provinces, with issues in training process quality being particularly prominent. CONCLUSIONS The management system, hardware facilities, and preceptor staffing of clinical pharmacist training bases in China are relatively well-established, yet notable variations in quality management exist among training bases across different provinces.
6.Analysis of dosimetric characteristics of proton radiotherapy in 4 cases of breast cancer
Chengqiang LI ; Yungang WANG ; Yishan YU ; Shizhang WU ; Cheng TAO ; Xingmin MA ; Tianyuan DAI ; Jinghao DUAN ; Jinhu CHEN ; Tong BAI ; Jian ZHU
Journal of International Oncology 2025;52(7):448-454
Objective:To explore the dosimetric characteristics of proton and photon radiotherapy in the treatment of breast cancer.Methods:Four female breast cancer patients who needed radiotherapy at Shandong Cancer Hospital and Institute from January 2024 to May 2024 were selected as the research subjects. The target area ranges of 4 patients were left-sided breast cancer with lymph node involvement, left-sided breast cancer with lymph node involvement and internal mammary node, right-sided breast cancer with lymph node involvement and internal mammary node and synchronous bilateral breast cancer. Intensity modulated proton therapy (IMPT) and intensity modulated radiation therapy (IMRT) plans were designed respectively based on the prescribed dose in the target area and the limits of organs at risk (tomotherapy plan for bilateral breasts). The conformity index (CI), homogeneity index (HI), gradient index (GI) and organs at risk doses were evaluated. The dosimetric characteristics of IMPT and photon radiotherapy were compared.Results:Both IMPT and photon radiotherapy plans of the 4 breast cancer cases met the clinical dose requirements. The HI value of IMPT plans (0.10-0.14) was comparable to that of photon radiotherapy plans (0.10-0.12), and the average CI of the photon radiotherapy plans was 0.10 higher than that of the IMPT plans, and the average GI was 0.55 lower than that of the IMPT plans. The D mean of ipsilateral lung and heart of IMPT was lower, especially in the low-dose area (V 0-3), which was significantly lower than the photon radiotherapy plans, D mean of ipsilateral lung was reduced by 12.2%, 6.1%, 16.1% and 34.8%, respectively, D mean of heart was reduced by 47.2%, 57.0%, 72.4% and 83.0%, respectively. The ipsilateral lung V 20 of IMPT was not lower than photon radiotherapy plans (unilateral breast: IMPT was 30.0%-34.0%, IMRT was 29.0%-35.9%) . Conclusions:IMPT significantly reduces the D mean to the ipsilateral lung and heart while ensuring dose coverage of the target in breast cancer, preventing more volume of surrounding normal tissues from being irradiated. However, IMPT does not show much more advantage than photon radiotherapy plans in the ipsilateral lung V 20.
7.Safety and efficacy of Angong Niuhuang Pills in patients with moderate-to-severe acute ischemic stroke (ANGONG TRIAL): A randomized double-blind placebo-controlled pilot clinical trial.
Shengde LI ; Anxin WANG ; Lin SHI ; Qin LIU ; Xiaoling GUO ; Kun LIU ; Xiaoli WANG ; Jie LI ; Jianming ZHU ; Qiuyi WU ; Qingcheng YANG ; Xianbo ZHUANG ; Hui YOU ; Feng FENG ; Yishan LUO ; Huiling LI ; Jun NI ; Bin PENG
Chinese Medical Journal 2025;138(5):579-588
BACKGROUND:
Preclinical studies have indicated that Angong Niuhuang Pills (ANP) reduce cerebral infarct and edema volumes. This study aimed to investigate whether ANP safely reduces cerebral infarct and edema volumes in patients with moderate to severe acute ischemic stroke.
METHODS:
This randomized, double-blind, placebo-controlled pilot trial included patients with acute ischemic stroke with National Institutes of Health Stroke Scale (NIHSS) scores ranging from 10 to 20 in 17 centers in China between April 2021 and July 2022. Patients were allocated within 36 h after onset via block randomization to receive ANP or placebo (3 g/day for 5 days). The primary outcomes were changes in cerebral infarct and edema volumes after 14 days of treatment. The primary safety outcome was severe adverse events (SAEs) for 90 days.
RESULTS:
There were 57 and 60 patients finally included in the ANP and placebo groups, respectively for modified intention-to-treat analysis. The median age was 66.0 years, and the median NIHSS score at baseline was 12.0. The changes in cerebral infarct volume at day 14 were 0.3 mL and 0.4 mL in the ANP and placebo groups, respectively (median difference: -7.1 mL; interquartile range [IQR]: -18.3 to 2.3 mL, P = 0.30). The changes in cerebral edema volume of the ANP and placebo groups on day 14 were 11.4 mL and 4.0 mL, respectively ( median difference: 3.0 mL, IQR: -1.3 to 9.9 mL, P = 0.15). The rates of SAE within 90 days were similar in the ANP (3/57, 5%) and placebo (7/60, 12%) groups ( P = 0.36). Changes in serum mercury and arsenic concentrations were comparable. In patients with large artery atherosclerosis, ANP reduced the cerebral infarct volume at 14 days (median difference: -12.3 mL; IQR: -27.7 to -0.3 mL, P = 0.03).
CONCLUSIONS:
ANP showed a similar safety profile to placebo and non-significant tendency to reduce cerebral infarct volume in patients with moderate-to-severe stroke. Further studies are warranted to assess the efficacy of ANP in reducing cerebral infarcts and improving clinical prognosis.
TRAIL REGISTRATION
Clinicaltrials.gov , No. NCT04475328.
Aged
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Female
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Humans
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Male
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Middle Aged
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Double-Blind Method
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Drugs, Chinese Herbal/adverse effects*
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Ischemic Stroke/drug therapy*
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Pilot Projects
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Stroke/drug therapy*
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Treatment Outcome
8.Challenges and strategies for implementing the STAR tool for comprehensive evaluation of guidelines: A qualitative study with Chinese clinicians.
Nan YANG ; Xu WANG ; Hongfeng HE ; Jungang ZHAO ; Yishan QIN ; Yueyan LI ; Janne ESTILL ; Junmin WEI ; Yaolong CHEN
Chinese Medical Journal 2025;138(21):2681-2692
BACKGROUND:
The STAR (Scientific, Transparent, and Applicable Rankings) working group conducts regular evaluations of Chinese guidelines and consensus statements. This study gathered insights from STAR working group members using qualitative interviews.
METHODS:
From March to August 2023, members of the STAR specialist committees were interviewed using semi-structured interview outline. The interviewees were selected through purpose-based sampling. Subject analysis was employed to summarize the findings.
RESULTS:
We conducted interviews with 37 members from 36 committees and summarized the contents into four main themes and 16 specific topics. The value of STAR in enhancing the development and selection of high-quality guidelines in China was commonly mentioned. Challenges identified included the lack of resources and suboptimal organizational structures, collaboration, and evaluation efficiency. Suggestions for the STAR tool included developing extensions for different guideline types, adjusting certain items, and better covering guideline applicability. The promotion of STAR and the consideration of an international committee for global outreach were also highlighted.
CONCLUSION
STAR has exerted a substantial influence on the evaluation of Chinese guidelines, and the insights gained from interviews offer valuable directions for its further enhancement.
Humans
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China
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Qualitative Research
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Practice Guidelines as Topic
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Interviews as Topic
9.Comparative outcomes of single versus dual antiplatelet therapy following transcatheter aortic valve replacement
Yishan MA ; Liu LI ; Yu WANG ; Jie ZHOU ; Le WANG ; Zhiyu YANG
Journal of China Medical University 2025;54(7):626-630,637
Objective To compare the effects of single antiplatelet therapy(SAPT)versus dual antiplatelet therapy(DAPT)on bleeding and ischemic events in patients undergoing transcatheter aortic valve replacement(TAVR)without long-term anticoagulation indications.Methods This randomized controlled trial included 90 post-TAVR patients without anticoagulation indications,who were allocated to the SAPT group(n=46,aspirin 100 mg/d)or DAPT group(n=44,aspirin 100 mg/d+clopidogrel 75 mg/d for 3 months,followed by aspirin monotherapy).Maximum aggregation rates of platelets induced by arachidonic acid(MARAA)and adenosine diphosphate(MARADP)were measured 1,3,6,and 12 months postoperatively.Bleeding and ischemic events were recorded during the follow-up visits.Results The SAPT group exhibited significantly higher MARAA and MARADP scores at 1 and 3 months,and higher MARAA scores at 6 months compared to the DAPT group(P<0.05).At the 12-month follow-up,the SAPT group had a significantly lower inci-dence of bleeding events compared to the DAPT group(13.0%vs.31.8%,P=0.043).No statistically significant difference was observed in ischemic events between the groups(15.2%vs.11.4%,P=0.759).Conclusion For TAVR patients without anticoagulation indica-tions,SAPT significantly reduced the 1-year bleeding risk compared to DAPT,without increasing ischemic events.These findings support the safety and efficacy of SAPT after TAVR.
10.Effect of Go-Ichi-Ni-San complex subunit 1 on disease progression and chemotherapy resistance in hepatocellular carcinoma
Yishan HUO ; Dawei LI ; Xiangbing DUAN ; Yuyu MA ; Guojun ZHANG ; Kainan ZHANG ; Xiumin MA
Journal of Clinical Hepatology 2025;41(3):485-492
ObjectiveTo investigate the role and mechanism of Go-Ichi-Ni-San complex subunit 1 (GINS1) in the progression of hepatocellular carcinoma (HCC) and the development of chemotherapy resistance. MethodsThe tumor database GEPIA2 was used to analyze the differential expression of GINS1 between HCC patients and healthy individuals, and pathological tissue samples were collected from 40 HCC patients who were admitted to The Affiliated Tumor Hospital of Xinjiang Medical University and the First Affiliated Hospital of Xinjiang Medical University from May 2017 to January 2021. Immunohistochemical staining was used to measure the difference in the expression of GINS1 between HCC tissue and corresponding adjacent tissue, and the correlation between the expression level of GINS1 and the clinical TNM stage of HCC was analyzed. Western blot was also used to measure the difference in the expression of GINS1 between HCC Huh7/Hep3B/Li-7/MHCC97H cell lines and normal human QSG7701 hepatocytes. The method of lentivirus transfection was used to establish the MHCC97H cell line with stable GINS1 knockdown and its negative control cell line. CCK-8 assay and colony formation assay were used to measure cell proliferative capacity; scratch assay was used to measure cell migration ability; Transwell assay was used to measure cell invasion ability; cells were treated with oxaliplatin to measure their sensitivity to chemotherapy drugs. Nude mice were used to establish a tumor-bearing model and observe the effect of GINS1 knockdown on the growth of HCC in vivo. Western Blot was used to measure the expression levels of the proteins associated with the Notch pathway and the JAK/STAT pathway. The cells were treated with the Notch receptor agonist Jagged-1 to analyze the association between GINS1 and the Notch/JAK/STAT pathway. The independent-samples t test was used for comparison of continuous data between two groups; a one-way analysis of variance was used for comparison between multiple groups, and the least significant difference t-test was used for further comparison between two groups. ResultsThe expression of GINS1 was upregulated in HCC patients, HCC tissue, and HCC cell lines (all P<0.05), and the expression level of GINS1 was positively correlated with the clinical TNM stage of HCC (r=0.822, P=0.011). Compared with the negative control cells, the GINS1-knockdown MHCC97H cells showed significant reductions in proliferation, migration, and invasion activities (all P<0.01) and a significantly enhanced sensitivity to oxaliplatin (P<0.01). Compared with the nude mice in the control group, GINS1 knockdown caused significant inhibition of tumor weight and volume in vivo in nude mice (all P<0.001). Compared with the negative control cells, the GINS1-knockdown MHCC97H cells showed significant reductions in the expression levels of Notch1, Notch3, p-JAK2, and p-STAT3 (all P<0.05), while there were no significant differences in the overall expression levels of JAK2 and STAT3 (P>0.05). After Jagged-1 treatment, the GINS1-knockdown MHCC97H cells showed significant increases in proliferation, migration, and invasion activities and a significant reduction in sensitivity to oxaliplatin, as well as significant increases in the levels of p-JAK2 and p-STAT3 (all P<0.05). ConclusionGINS1 is upregulated in HCC and can promote HCC progression and chemotherapy resistance through the Notch/JAK2/STAT3 pathway.

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