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.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
7.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
8.STAR Guideline Terminology(Ⅱ): Clinical Question Formulation, Evidence Retrieval and Appraisal, and Recommendation Development
Di ZHU ; Haodong LI ; Zijun WANG ; Qianling SHI ; Hui LIU ; Yishan QIN ; Yuanyuan YAO ; Zhewei LI ; Hongfeng HE ; Jinhui TIAN ; Long GE ; Yaolong CHEN ;
Medical Journal of Peking Union Medical College Hospital 2025;16(3):756-764
To introduce and analyze guideline terminology related to clinical question formulation, evidence retrieval and appraisal, and recommendation development. A systematic search was conducted in guideline development manuals and relevant methodological literature, covering publications up to October 25, 2024. Terminology related to the three aforementioned stages of related to guideline development was extracted from the included literature, standardized, and refined through consensus meetings to finalize a comprehensive terminology list and definitions. A total of 30 guideline development manuals and 15 methodological articles were included, and 23 core terms were identified. It is recommended to develop a standardized and scientifically sound guideline terminology system with unified naming, clear definitions, and alignment with the linguistic environment and usage habits in China. At the same time, it is essential to strengthen terminology training for both guideline developers and users based on this system, in order to deepen their correct understanding and proper application of guideline terminology.
9.Expression of serum miR-15a,miR-195-5p,miR-33 in patients with gestational diabetes and their relationship with maternal and infant outcomes
Haihong WANG ; Cui ZHAO ; Yishan LI ; Shuying CHEN
The Journal of Practical Medicine 2025;41(16):2533-2540
Objective To investigate the expression levels of serum microRNA-15a(miR-15a),microRNA-195-5p(miR-195-5p),and microRNA-33(miR-33)in pregnant women with gestational diabetes mellitus(GDM)and to explore their associations with maternal and neonatal outcomes.Methods The research subjects were selected from 208 patients with GDM who completed delivery at our hospital between September 2021 and October 2024.Based on maternal pregnancy outcomes,the subjects were categorized into either the poor maternal outcome group or the good maternal outcome group.Similarly,they were classified into the poor perinatal outcome group and the good perinatal outcome group according to perinatal outcomes.Clinical data and serum levels of fasting plasma glucose(FPG),miR-15a,miR-195-5p,and miR-33 were collected and compared between groups with different maternal and perinatal outcomes.Multivariate logistic regression analysis was conducted to identify risk factors associated with adverse maternal and perinatal outcomes among GDM patients.Additionally,the predictive value of these biomarkers for adverse maternal and perinatal outcomes was evaluated using receiver operating characteristic(ROC)curve analysis.Results Among 208 patients with GDM,81 experienced adverse maternal pregnancy outcomes(38.94%).Of the 192 newborns,51 cases were associated with adverse perinatal outcomes,resulting in an incidence rate of 26.56%.Multivariate logistic regression analysis revealed that a high insulin resistance index(OR=2.197),poor glycemic control(OR=2.482),a history of adverse pregnancy or childbirth(OR=2.838),elevated FPG levels(OR=1.910),increased serum expression of miR-15a(OR=1.988),miR-195-5p(OR=2.273),and miR-33(OR=2.479)were independent risk factors for adverse maternal pregnancy outcomes in GDM patients(P<0.05).The area under the receiver operating characteristic curve(AUC)for the combined detection of miR-15a,miR-195-5p,and miR-33 was higher than that of FPG alone in predicting maternal pregnancy outcomes,with the combined detection showing the highest AUC(P<0.05).Similarly,multivariate logistic regression results also indicated that elevated levels of the aforementioned biomarkers—insulin resistance index(OR=2.155),poor glycemic control(OR=2.408),history of adverse pregnancy or childbirth(OR=2.838),FPG(OR=2.018),miR-15a(OR=2.197),miR-195-5p(OR=2.246),and miR-33(OR=3.043)—were independent risk factors for adverse perinatal outcomes in GDM patients(P<0.05).The AUC for combined detection of miR-15a,miR-195-5p,and miR-33 was significantly higher than that of FPG alone in predicting perinatal outcomes,with the combination yielding the highest predictive accuracy(P<0.05).Conclusions Patients with GDM are at increased risk of adverse maternal and perinatal outcomes.Elevated insulin resistance index,poor glycemic control,a history of adverse pregnancy or childbirth,and increased serum levels of miR-15a,miR-195-5p,and miR-33 were identified as independent risk factors for adverse pregnancy outcomes in individuals with gestational diabetes.The individual measurement of miR-15a,miR-195-5p,and miR-33,as well as their combined detection,demonstrated greater predictive value for pregnancy outcomes in GDM patients compared to FPG alone,with the combined detection showing the highest predictive accuracy.
10.Construction of drug utilization evaluation criteria for Dezocine injection based on evidence-based methodology and Delphi method
Yuanyuan GUO ; Chao WANG ; Yinpeng QIN ; Yi ZHANG ; Yishan BU
China Pharmacy 2025;36(15):1841-1845
OBJECTIVE To construct the drug utilization evaluation criteria for Dezocine injection,so as to provide reference for the rational drug use in medical institutions.METHODS On the basis of evidence methodology,relevant guidelines/expert consensus,systematic reviews/meta-analysis were consulted;the evaluation criteria framework for Dezocine injection was established after screening evidence.Delphi method was employed,whereby 28 clinicians and clinical pharmacists from secondary and above-level medical institutions across eight provinces,including Tianjin,Beijing and Shandong,were selected to participate in two rounds of questionnaire surveys.The final indicators were determined based on the experts'enthusiasm coefficient,authority coefficient,and degree of coordination.RESULTS The effective recovery rate of questionnaire was 100%in the first round and 92.86%in the second round;expert authority coefficient was 0.82 in the first round and 0.81 in the second round;the coordination degree of experts in the first round was 0.29,and in the second round was 0.31(P<0.001).Drug utilization evaluation standard system for Dezocine injection was formed finally,including three dimensions of medication indications,medication process and medication results,with a total of 11 first-level indicators(such as indications,usage and dosage)and 33 second-level indicators(such as labor analgesia and the management of severe pain following major or moderate surgeries combined with other analgesic drugs).The average importance scores for each indicator ranged from 4.08 to 5.00 points,with an overall average score of 4.61 points and coefficient of variation ranging from 0 to 0.19.CONCLUSIONS The drug utilization evaluation criteria for Dezocine injection established based on evidence-based methodology and Delphi method is authoritative and scientific,which provides a reference for subsequent evaluation of the rationality of clinical medication.

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