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.External review of the recommendations of the Guidelines for Evidence-based Use of Biological Agents for the Clinical Treatment of Osteoporosis: a cross-sectional survey
Lingling YU ; Shuang LIU ; Zaiwei SONG ; Qiusha YI ; Yu ZHANG ; Liyan MIAO ; Zhenlin ZHANG ; Chunli SONG ; Yaolong CHEN ; Lingli ZHANG ; Rongsheng ZHAO
China Pharmacy 2025;36(9):1025-1029
OBJECTIVE To assess the scientific rigor, clarity and feasibility of the recommendations of the Guidelines for Evidence-based Use of Biological Agents for the Clinical Treatment of Osteoporosis (hereinafter referred to as the Guideline) through external review, in order to further revise and improve the Guideline recommendations. METHODS This study employed a cross-sectional survey research design, a convenience sampling method was adopted to select frontline medical workers in the field of osteoporosis (including clinical doctors, clinical pharmacists, and nurses) as well as patients or their family members. External review was conducted through a combination of closed-ended and open-ended electronic questionnaires to get feedback from them on the appreciation,clarity and feasibility of the 32 preliminary recommendations in the Guideline. RESULTS A total of 90 external review subjects from 15 hospitals were collected, including 45 clinical doctors, 15 clinical pharmacists, 15 nurses and 15 patients or their family members. The overall appreciation degree of recommendations was 99.38%, the overall clarity degree of recommendations was 98.92%, and the overall feasibility degree of recommendations was 99.65%. At the same time, 111 subjective suggestions were collected, which provided an important reference for the further improvement of the Guideline recommendations. Based on the above feedback, the Guideline steering committee and core expert group revised the wording of 12 draft recommendations without deletion, and finally determined 32 recommendations. CONCLUSIONS The external review provides an important basis for the final formation of the Guideline, further improves the scientific rigor, clarity and feasibility of the recommendations, and ensures the standardization, practicality and implementability of the Guideline.
7.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.
8.Collection and determination of clinical issues in Clinical practice guidelines for postoperative pain management in adults ( 2024 edition) based on Delphi method
Yan WANG ; Yingying ZHAO ; Younian XU ; Yuanyuan YAO ; Jie ZHANG ; Junxian ZHAO ; Tianhu LIANG ; Yaolong CHEN ; Qinjun CHU ; Xiangdong CHEN ; Yunshui PENG ; Jianjun YANG
Chinese Journal of Anesthesiology 2025;45(7):802-807
Objective:To determine the clinical issues in the Clinical practice guidelines for postoperative pain management in adults (2024 edition). Methods:A preliminary list of clinical issues for the guidelines was developed through literature review, clinical surveys, and expert interviews. This was followed by two rounds of Delphi questionnaire surveys, with quality control and statistical analysis conducted using expert positive coefficient, mean item scores, full score ratio, coefficient of variation, Cronbach′s α coefficient, and expert authority level to finalize the list of clinical issues.Results:The experts participating in the Delphi questionnaire surveys had multidisciplinary collaborative backgrounds and regional representativeness, with a high level of authority. The overall positive coefficient of expert participation in the surveys was 78.9%. Through two rounds of the Delphi method and based on the screening criteria of a mean score ≥3.5, coefficient of variation ≤30%, and full score ratio ≥30%, 17 clinical issues were ultimately included following an expert consensus meeting.Conclusions:Through the Delphi method and rigorous quality control, the clinical issues in the Clinical practice guidelines for postoperative pain management in adults (2024 edition) are determined, laying a foundation for the subsequent development of the guidelines.
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.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

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