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.Consideration of Health Economics Evidence in Clinical Practice Guidelines: Methods and Steps
Dongrui PENG ; Qi ZHOU ; Xufei LUO ; Zijun WANG ; Hui LIU ; Junxian ZHAO ; Jinghong HUANG ; Hongyu HU ; Xin XING ; Jing WU ; Shitong XIE ; Xiaohui WANG ; Yaolong CHEN
Medical Journal of Peking Union Medical College Hospital 2026;17(3):862-870
Health economics evidence plays an important role in linking clinical value evidence with health resource allocation decisions in the development of clinical practice guidelines. It can not only effectively balance clinical effectiveness and economic feasibility but also avoid forming "idealized" recommendations that are detached from the affordability of the healthcare system or the burden-bearing capacity of patients. To promote guideline developers to use health economics evidence more standardizedly and fully, this paper conducts an in-depth analysis of the current application status, existing challenges, access channels, and application processes of health economics evidence in current guidelines, and on this basis, puts forward considerations and suggestions for strengthening and standardizing the application of health economics evidence in China's clinical practice guidelines.
4.Methodological Issues in the Design,Evaluation,and Reporting of Randomized Controlled Trials with "Pattern Dominating Disease"
Lu WANG ; Jiajia WANG ; Yingying ZHANG ; Xufei LUO ; Yaolong CHEN ; Jiansheng LI
Journal of Traditional Chinese Medicine 2026;67(14):1497-1502
This study explores methodological issues in the design, evaluation, and reporting of randomized controlled trials (RCTs) under the concept of "syndrome dominating disease". The discussion focuses on key aspects including the adaptability of trial design, the screening of research participants, the standardization of syndrome differentiation, the balance between intervention individualization and standardization, the integration of multi-dimensional outcome measures, and the limitations of existing evaluation and reporting tools when applied to this type of research, along with corresponding recommendations and future perspectives. Regarding research design, it is recommended to select or draw upon innovative design concepts such as basket trials and subgroup-based dynamic/static parallel-group designs, in order to innovate the design format of RCTs. Meanwhile, criteria for participant screening, TCM syndrome differentiation, and disease classification should be standardized. The balance should be appropriately achieved between intervention individualization and standardization, and a multidimensional assessment system encompassing TCM syndromes, disease-specific outcomes, and patient-reported outcomes should be established. For risk of bias assessment and research reporting, it is recommended,to develop specialized assessment and reporting tools based on existing instruments, in order to standardize the assessment and reporting of study findings. Future research may further explore the potential applications of artificial intelligence in the study design, risk-of-bias assessment, and reporting quality assessment of RCTs based on the "syndrome dominating disease" model, with a particular focus on methodological optimization, data integration, and enhancement of research quality.
5.Methodological Issues in the Design,Evaluation,and Reporting of Randomized Controlled Trials with "Pattern Dominating Disease"
Lu WANG ; Jiajia WANG ; Yingying ZHANG ; Xufei LUO ; Yaolong CHEN ; Jiansheng LI
Journal of Traditional Chinese Medicine 2026;67(14):1497-1502
This study explores methodological issues in the design, evaluation, and reporting of randomized controlled trials (RCTs) under the concept of "syndrome dominating disease". The discussion focuses on key aspects including the adaptability of trial design, the screening of research participants, the standardization of syndrome differentiation, the balance between intervention individualization and standardization, the integration of multi-dimensional outcome measures, and the limitations of existing evaluation and reporting tools when applied to this type of research, along with corresponding recommendations and future perspectives. Regarding research design, it is recommended to select or draw upon innovative design concepts such as basket trials and subgroup-based dynamic/static parallel-group designs, in order to innovate the design format of RCTs. Meanwhile, criteria for participant screening, TCM syndrome differentiation, and disease classification should be standardized. The balance should be appropriately achieved between intervention individualization and standardization, and a multidimensional assessment system encompassing TCM syndromes, disease-specific outcomes, and patient-reported outcomes should be established. For risk of bias assessment and research reporting, it is recommended,to develop specialized assessment and reporting tools based on existing instruments, in order to standardize the assessment and reporting of study findings. Future research may further explore the potential applications of artificial intelligence in the study design, risk-of-bias assessment, and reporting quality assessment of RCTs based on the "syndrome dominating disease" model, with a particular focus on methodological optimization, data integration, and enhancement of research quality.
6.STAR Guideline Terminology (I): Planning and Launching
Zhewei LI ; Qianling SHI ; Hui LIU ; Xufei LUO ; Zijun WANG ; Jinhui TIAN ; Long GE ; Yaolong CHEN
Medical Journal of Peking Union Medical College Hospital 2025;16(1):216-223
To develop a guideline terminology system and promote its standardization, thereby enhancing medical staff's accurate understanding and correct application of guidelines. A systematic search was conducted for guideline development manuals and method ological literature (as of October 25, 2024). After screening, relevant terms from the guideline planning and launching stages were extracted and standardized. The term list and definitions were finalized through discussion and evaluation at a consensus conference. A total of 36 guideline manuals and 14 method ological articles were included, and 27 core terms were identified. The standardization of guideline terminology is essential for improving guideline quality, facilitating interdisciplinary communication, and enhancing other related aspects. It is recommended that efforts to advance the standardization and continuous updating of the terminology system should be prioritized in the future to support the high-quality development of guidelines.
7.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.
8.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.
9.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.
10.Overview of Real-time Delphi Method and Its Application in Guidelines
Haiyun WANG ; Ruobing LEI ; Xuan YU ; Hui LIU ; Qiu LI ; Yaolong CHEN
Medical Journal of Peking Union Medical College Hospital 2025;16(6):1571-1577
The real-time Delphi method represents a refinement of the classical Delphi technique, designed to overcome limitations such as prolonged study duration and delayed feedback during consensus development. This article, building upon the classical Delphi foundation, systematically elaborates on the application process, advantages, and limitations of the real-time Delphi method. It further presents currently available websites or software capable of facilitating real-time Delphi exercises and offers considerations and recommendations for its application in guideline development, aiming to serve as a reference for relevant researchers.

Result Analysis
Print
Save
E-mail