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.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.
4.Progress in role of interaction between mitophagy and NLRP3 inflamma-some in diabetic retinopathy injury
Yishan WANG ; Xiangxia LUO ; Li SU ; Qing LIU
Chinese Journal of Pathophysiology 2025;41(3):600-605
Diabetic retinopathy(DR)is one of the common serious microvascular complications in diabetic patients,with the main pathological features of retinal vascular injury,oxidative stress and chronic inflammatory re-sponse.In recent years,more and more studies have shown that mitophagy plays an important role in maintaining the func-tional homeostasis of retinal cells and preventing oxidative damage,and nucleotide-binding oligomerization domain-like re-ceptor protein 3(NLRP3)is a key regulator of pro-inflammatory response in DR.Mitophagy can reduce the excessive pro-duction of reactive oxygen species(ROS)by removing damaged mitochondria,thereby inhibiting the activation of NLRP3 inflammasome.In contrast,mitochondrial dysfunction can lead to excessive activation of NLRP3 inflammasome,which further aggravates the inflammatory response and apoptosis of the retina.Therefore,this article reviews the independent role of mitophagy and NLRP3 inflammasome in DR and their mutual regulatory mechanisms,so as to provide reference for the study of mitophagy and NLRP3 inflammasome as targets.
5.Clinical features of chronic hepatitis C patients with genotype 3 infection:A multicenter retrospective cohort study
Jingyi XIE ; Yujia JING ; Yishan LIU ; Manling BAI ; Zhangqian CHEN ; Qiang XU ; Hong DU ; Yuxiu MA ; Liting ZHANG ; Shanshan ZHU ; Xiaoqin GAO ; Xinggang BAI ; Guoying YU ; Jianqi LIAN ; Xiaozhong WANG ; Yongping ZHANG ; Jiuping WANG ; Fanpu JI ; Jianjun FU ; Ning GAO
Journal of Clinical Hepatology 2025;41(8):1533-1540
Objective To investigate the clinical features of chronic hepatitis C(CHC)patients with hepatitis C virus genotype 3(HCV GT3)infection and the risk factors for disease progression.Methods A multicenter retrospective cohort study was conducted among 1 002 CHC patients from 11 clinical centers in Northwest China from December 2017 to November 2023,and according to their genotype,they were divided into GT1,GT2,GT3,and GT6 groups.Clinical features were compared between the patients with different genotypes.The one-way analysis of variance was used for comparison of normally distributed continuous data between groups,and the Scheffe test was used for further comparison between two groups.The Kruskal-Wallis H test was used for comparison of data with skewed distribution between groups;the chi-square test or Fisher test was used for comparison of categorical data between groups.The multivariate logistic regression analysis was used to explore the influencing factors for the progression of CHC to liver cirrhosis.Results In terms of the genotype,there were 427 patients with GT1 infection,242 with GT2 infection,299 with GT3 infection(210 patients with GT3a infection,87 with GT3b infection,and 2 with unclassified genotype),and 34 with GT6 infection.The patients with GT3 infection had a significantly younger age than those with GT1 infection(51.3±0.5 years vs 53.2±0.6 years,P<0.05)or GT2 infection(51.3±0.5 years vs 53.7±0.8 years,P<0.05),and for the patients with liver cirrhosis,the patients with GT3 infection had a significantly younger age than those with GT1 infection(52.1±0.5 years vs 59.4±0.9 years,P<0.001)or GT2 infection(52.1±0.5 years vs 58.1±1.1 years,P<0.001).Among the patients with GT3 infection,male patients accounted for 77.9%and the patients with liver cirrhosis accounted for 46.2%,which were significantly higher than those among the patients with GT1,GT2 or GT6 infection(all P<0.001).At baseline,the patients with GT3 infection had significantly higher levels of alanine aminotransferase(ALT)and aspartate aminotransferase(AST)than those with GT1 or GT2 infection,significantly higher aspartate aminotransferase-to-platelet ratio index(APRI)and fibrosis-4(FIB4)than those with GT1,GT2 or GT6 infection,a significantly lower platelet count(PLT)than those with GT2 or GT6 infection,a significantly higher level of alpha-fetoprotein than those with GT2 or GT6 infection,and a significantly lower level of albumin(Alb)than those with GT6 infection(all P<0.05).There were no significant differences between the patients with GT3a infection and those with GT3b infection in age,sex,the proportion of patients with liver cirrhosis,comorbidities,HCV RNA quantification,PLT,ALT,AST,alkaline phosphatase,Alb,APRI,and FIB-4(all P>0.05).The multivariate logistic regression analysis showed that PLT≤150×109/L(odds ratio[OR]=10.72,95%confidence interval[CI]:5.76-35.86,P<0.001)and Alb≤35 g/L(OR=3.74,95%CI:1.22-11.45,P=0.021)were risk factors for liver cirrhosis.Conclusion Most CHC patients with GT3 infection are male in Northwest China,and compared with the patients with other genotypes,such patients tend to have a younger age of onset and higher degrees of liver inflammation activity and fibrosis.Low PLT and a low level of Alb are risk factors for progression to liver cirrhosis in CHC patients with GT3 infection.
6.Analysis of the clinical efficacy-value of electroacupuncture manipulation and massage therapy in the treatment of knee osteoarthritis
Xianzhen WEI ; Haiyun WANG ; Yishan DING ; Chaowei CHEN
China Modern Doctor 2025;63(5):39-41,52
Objective To observe the clinical efficacy of electroacupuncture manipulation combined with massage therapy in the treatment of knee osteoarthritis,and to analyze the efficacy-value.Methods A total of 118 patients with knee osteoarthritis admitted to Kuitun Traditional Chinese Medicine Hospital of Xinjiang Production and Construction Corps from January 2023 to January 2024 were selected as research subjects and divided into electroacupuncture manipulation and massage group(n=60)and sodium hyaluronate group(n=58)by random number table methood.Electroacupuncture manipulation and massage group was treated 3 times a week for 3 weeks.Sodium hyaluronate group was injected with sodium hyaluronate injection in the joint cavity once a week for 3 weeks.Knee function scores and effective rate of two groups before and after treatment were observed,and the differences between two treatments were compared by using the health economics evaluation method.Results After comparing the patients before and after treatment,the knee function scores improved.There was significant difference of knee function scores after treatment between two groups(P<0.05).There were significant difference of response rate and the incidence of adverse effects between two groups(P<0.05).Sodium hyaluronate group had a better clinical efficacy-value than electroacupuncture manipulation and massage group.Conclusion Electroacupuncture manipulation and massage and sodium hyaluronate intra-articular injection can effectively improve joint pain and joint function in patients,and intra-articular injection of sodium hyaluronate has a higher incidence of adverse reactions.
7.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.
8.A survey of awareness of guidelines and consensus and an analysis of the effectiveness of methodology training among medical staff in otorhinolaryngology head and neck surgery
Hui LIU ; Yuanyuan YAO ; Zijun WANG ; Qianling SHI ; Yishan QIN ; Honghao LAI ; Long GE ; Yaolong CHEN
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2025;60(7):824-830
Objective:To investigate the awareness of clinical practice guidelines (referred to as "guidelines") and experts consensus (referred to as "consensus") among otorhinolaryngology head and neck surgery medical staff, and to analyze the effectiveness of the ninth guideline methodology workshop.Methods:Self-designed survey questionnaires were used to conduct two surveys among otorhinolaryngology head and neck surgery medical staff who participated in the ninth guideline methodology workshop held in Chengdu from Jannuary 10 to 11, 2025, both before and after the training, to assess their awareness and knowledge of guideline and consensus development methodology. The effectiveness of the training was evaluated using the paired chi-square test.Results:A total of 77 peoples (95.06%), who participated in the ninth guideline methodology workshop, completed the survey questionnaires both before and after the training. One-third of the respondents reported a relatively good to very good understanding of guideline and consensus development. The overall methodology of the guidelines and consensus they had participated in developing still showed room for improvement. After the methodology training, the score rate for each test question significantly increased compared to before the training ( P<0.05), and the distribution trend of the total scores changed markedly (Before the training, 71 people scored less than 60 points, 4 people scored 60 points, and 2 people scored 70 points. After the training, only 1 person scored less than 60 points, 1 person scored 60 points, and 75 people scored between 70 and 100 points, of which 21 people scored 100 points). Conclusion:The awareness of guideline and consensus development methodology among otorhinolaryngology head and neck surgery medical staff still has room for improvement. The guideline methodology workshop can enhance participants′ mastery of guideline and consensus development methodology.
9.STAR Guideline Terminology(Ⅲ):Reporting,Evaluation,Dissemination,Implementation and Updating
Hongfeng HE ; Hui LIU ; Qianling SHI ; Yuanyuan YAO ; Yishan QIN ; Zijun WANG ; Jinhui TIAN ; Long GE ; Xiaohui WANG ; Yaolong CHEN
Medical Journal of Peking Union Medical College Hospital 2025;16(4):1018-1025
Objective To sort,summarize,and introduce key terms related to guideline reporting,evaluation,dissemination,implementation,and updating.Methods We systematically searched guideline de-velopment manuals and methodological literature from database inception to October 25,2024.Terms related to guideline reporting,updating,evaluation,and implementation were extracted,standardized,and finalized through a structured consensus process.Results A total of 13 guideline manuals and 32 methodological articles were included,yielding 14 core terms with standardized definitions.Conclusions This article introduces key terms such as reporting standards,external review,and research gaps across guideline development phases to promote concept application and deepen readers'understanding of guideline development.
10.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.
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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

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