1.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.
2.A Standardized Approach to Recommending Diagnostic Criteria in Chinese Clinical Practice Guidelines
Qi ZHOU ; Qinyuan LI ; Hongfeng HE ; Dongrui PENG ; Huayu ZHANG ; Ye WANG ; Kehu YANG ; Yaolong CHEN
Medical Journal of Peking Union Medical College Hospital 2024;15(6):1432-1438
Diagnostic criteria, as a critical component of clinical practice guidelines, play a direct role in guiding clinicians' diagnostic and treatment decisions. Although China has increasingly emphasized the development and updating of clinical guidelines in recent years, research focusing on the diagnostic criteria within these guidelines remains limited. This paper aims to explore the types of diagnostic criteria, the issues they present, and the processes involved in their formulation. Based on this analysis, suggestions are proposed to improve the recommendation and application of diagnostic criteria in Chinese guidelines.
3.Analysis of the Current Status of China's Adaptation Guidelines
Ling WANG ; Yaxuan REN ; Xufei LUO ; Di ZHU ; Zhewei LI ; Ye WANG ; Bingyi WANG ; Huayu ZHANG ; Shu YANG ; Yaolong CHEN
Medical Journal of Peking Union Medical College Hospital 2024;15(1):192-201
4.Methodology of Scientific, Transparent and Applicable Rankings for Chinese Guidelines and Consensus Related Literature Published in the Medical Journals: ample Identification and Speciality Assignment
Hui LIU ; Nan YANG ; Qianling SHI ; Xufei LUO ; Hairong ZHANG ; Jinhui TIAN ; Yinghui JIN ; Yaolong CHEN ; METHODOLOGY AND TECHNOLOGY SPECIALISATION COMMITTEE OF THE STAR WORKING GROUP
Medical Journal of Peking Union Medical College Hospital 2024;15(2):429-434
With the development of the Scientific, Transparent and Applicable Rankings tool for clinical practice guidelines(STAR), the publication of evaluation and ranking for scientificity, transparency and applicability of Chinese guidelines and consensus published in the medical journals in 2021and 2022, as well as the publication of the STAR evaluation and ranking for some specialities, the STAR evaluation and ranking has received widespread attention in the medical community. In order to further enhance its scientificity and transparency, Methodology and Technology Specialization Committee of the STAR Working Group presents this article to introduce sample identification and speciality assignment in the evaluation and ranking process.
5.Reflections on Developing Health Standards Based on Evidence-based Concept
Renfeng SU ; Hui LIU ; Qianling SHI ; Xufei LUO ; Nan YANG ; Junxian ZHAO ; Qiannan TIAN ; Juanjuan ZHANG ; Liqun WU ; Yaolong CHEN
Medical Journal of Peking Union Medical College Hospital 2024;15(2):435-441
National health standards involve all kinds of technical requirements formulated and numbered in accordance with the procedures and formats stipulated in the standardisation system for the implementation of national health and hygiene laws, regulations and policies, and the protection of human health. The establishment of health standards in China should align with our legal framework, including laws, regulations, departmental rules, and health and hygiene policies. During the development of these standards, a comprehensive approach is advocated, encompassing in-depth investigations, rigorous demonstrations, and extensive stakeholder engagement. However, the process of standard formulation may suffer from insufficient research evidence. The evidence-based concept emphasizes the significance of evidence. Therefore, integrating evidence-based concept into the process of developing health standards can enhance the quality and scientific basis of these standards. This article systematically elucidates the current status and development process of health standards in China, explores the necessity and feasibility of incorporating evidence-based concept into the development of these standards, analyzes the challenges and opportunities, and presents reflections and suggestions.
6.The Impact of Generative Artificial Intelligence on the Development, Evaluation, and Application of Clinical Practice Guidelines
Xufei LUO ; Han LYU ; Zaiwei SONG ; Hui LIU ; Zhixiang WANG ; Haodong LI ; Ye WANG ; Di ZHU ; Lu ZHANG ; Yaolong CHEN
Medical Journal of Peking Union Medical College Hospital 2024;15(5):1173-1181
Generative artificial intelligence (GAI) refers to AI technology capable of generating new content such as text, images, or audio from training data. GAI tools not only demonstrate rapid and efficient potential in literature screening, data extraction, and literature appraisal in systematic reviews, but can also be used for guideline evaluation and dissemination, enhancing the readability and promotion efficiency of guidelines. However, the accuracy of content generated by GAI tools, the rationality of cited evidence, the level of evidence, and the reliability of data still need verification. Additionally, data privacy protection and ethical issues are challenges that need to be addressed. This article aims to overview the current status of GAI tools in the formulation, evaluation, dissemination, and implementation of guidelines, explore the feasibility and new models of GAI tools in the field of guidelines, and improve the efficiency and quality of guideline formulation to better serve guideline developers and users.
7.A Standardized Approach to Recommending Diagnostic Criteria in Chinese Clinical Practice Guidelines
Qi ZHOU ; Qinyuan LI ; Hongfeng HE ; Dongrui PENG ; Huayu ZHANG ; Ye WANG ; Kehu YANG ; Yaolong CHEN
Medical Journal of Peking Union Medical College Hospital 2024;15(6):1432-1438
Diagnostic criteria, as a critical component of clinical practice guidelines, play a direct role in guiding clinicians' diagnostic and treatment decisions. Although China has increasingly emphasized the development and updating of clinical guidelines in recent years, research focusing on the diagnostic criteria within these guidelines remains limited. This paper aims to explore the types of diagnostic criteria, the issues they present, and the processes involved in their formulation. Based on this analysis, suggestions are proposed to improve the recommendation and application of diagnostic criteria in Chinese guidelines.
8.Development of the Scientific, Transparent and Applicable Rankings (STAR) tool for clinical practice guidelines.
Nan YANG ; Hui LIU ; Wei ZHAO ; Yang PAN ; Xiangzheng LYU ; Xiuyuan HAO ; Xiaoqing LIU ; Wen'an QI ; Tong CHEN ; Xiaoqin WANG ; Boheng ZHANG ; Weishe ZHANG ; Qiu LI ; Dong XU ; Xinghua GAO ; Yinghui JIN ; Feng SUN ; Wenbo MENG ; Guobao LI ; Qijun WU ; Ze CHEN ; Xu WANG ; Janne ESTILL ; Susan L NORRIS ; Liang DU ; Yaolong CHEN ; Junmin WEI
Chinese Medical Journal 2023;136(12):1430-1438
BACKGROUND:
This study aimed to develop a comprehensive instrument for evaluating and ranking clinical practice guidelines, named Scientific, Transparent and Applicable Rankings tool (STAR), and test its reliability, validity, and usability.
METHODS:
This study set up a multidisciplinary working group including guideline methodologists, statisticians, journal editors, clinicians, and other experts. Scoping review, Delphi methods, and hierarchical analysis were used to develop the STAR tool. We evaluated the instrument's intrinsic and interrater reliability, content and criterion validity, and usability.
RESULTS:
STAR contained 39 items grouped into 11 domains. The mean intrinsic reliability of the domains, indicated by Cronbach's α coefficient, was 0.588 (95% confidence interval [CI]: 0.414, 0.762). Interrater reliability as assessed with Cohen's kappa coefficient was 0.774 (95% CI: 0.740, 0.807) for methodological evaluators and 0.618 (95% CI: 0.587, 0.648) for clinical evaluators. The overall content validity index was 0.905. Pearson's r correlation for criterion validity was 0.885 (95% CI: 0.804, 0.932). The mean usability score of the items was 4.6 and the median time spent to evaluate each guideline was 20 min.
CONCLUSION
The instrument performed well in terms of reliability, validity, and efficiency, and can be used for comprehensively evaluating and ranking guidelines.
Reproducibility of Results
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Surveys and Questionnaires
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Practice Guidelines as Topic
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Humans
9.Protocols for guidelines on the diagnosis and treatment of atopic dermatitis (specialist version, general practitioner version and patient version)
Hao GUO ; Hui LIU ; Li ZHANG ; Guannan ZHU ; Ping WANG ; Zhirong YAO ; Xinghua GAO ; Yaolong CHEN
Chinese Journal of Dermatology 2023;56(9):809-814
In order to further standardize the diagnosis and treatment of atopic dermatitis by health-care professionals, as well as to enhance the awareness of atopic dermatitis among patients and promote doctor-patient communication, Chinese Society of Dermatology and China Dermatologist Association jointly initiated the development of guidelines on the diagnosis and treatment of atopic dermatitis (specialist version, general practitioner version and patient version). The development working group had planned the development process of the 3 versions of guidelines with reference to relevant development manuals and methodological articles. It is also intended to expound the details of registration, working group establishment, clinical question collection, evidence search and grading, recommendation formation and consensus through this protocol, aiming to enhance the transparency of guideline development.
10.Classification criteria and assessment tool of osteoarthritis: a scoping review
Cibo HUANG ; Nan YANG ; Zhiyi ZHANG ; Yingjuan CHEN ; Zhizhong YE ; Dan XING ; Yue ZHANG ; Xiaofeng ZENG ; Yaolong CHEN
Chinese Journal of Rheumatology 2019;23(2):82-88
Objective To analyze systematically the existing classification criteria and assessment tools for osteoarthritis (OA).Methods Comprehensively searched and screened the available classification criteria and assessment tools reported in OA guidelines,textbooks,including secondary and original researchs.We collected and summarized the extracted data with the methods of scoping review and also used Excel software for qualitative analysis.Results A total of 63 OA guidelines,1 textbook,239 secondary or original researches,160 supplementary records were retrieved.The 5 classification criteria and 15 systematic reviews of assessment tools (855 assessment tools) were finally included.Conclusion The existing classification criteria lack a rigorous and transparent development process,and they are also too complicate to guide clinical treatment.We suggest that the development and improvement of OA classification criteria should be linked with the streamlined assessment tools,and conduct trials to test in clinical practice.

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