1.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.
2.Improving the Certainty of Evidence in Animal Experiment Systematic Review/Meta-Analysis: An Empirical Study of the GRADE Method
Tengfei LI ; Qingyong ZHENG ; Jianguo XU ; Yiyi LI ; Yongjia ZHOU ; Caihua XU ; Mingyue ZHANG ; Jiexiang TIAN ; Gang WANG ; Jinhui TIAN
Laboratory Animal and Comparative Medicine 2025;45(1):101-111
Animal experiments are essential tools in biomedical research, serving as a bridge between basic research and clinical trials. Systematic reviews and meta-analyses (SRs/MAs) of animal experiments are crucial methods for integrating evidence from animal experiment, which can facilitate the translation of findings into clinical research, reduce translational risks, and promote resource integration in basic research. With the continuous development of the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) methodology, its application in SRs/MAs of animal experiments has gained increasing attention. This article first outlines the principles and specific applications of the GRADE methodology in SRs/MAs of animal experiments, including qualitative descriptive systematic reviews, meta-analyses, and network meta-analyses. It then deeply analyzes the misuse of the GRADE methodology in practice, including incorrect evidence grading, improper classification of evidence, misapplication in qualitative systematic reviews, inconsistencies between the documentation of the upgrading and downgrading process and results, and inappropriate use for making recommendations. Furthermore, this article comprehensively discusses the factors influencing the grading of evidence certainty in SRs/MAs of animal experiments, including the impact of bias risk, indirectness, inconsistency, imprecision, and publication bias on evidence downgrading, as well as the role of large effect sizes and cross-species consistency in evidence upgrading. Finally, in response to the issues discussed, improvement strategies are proposed, including further research and optimization of the GRADE methodology for SRs/MAs of animal experiments, the development of reporting guidelines tailored to the characteristics of SRs/MAs in animal experiment research, and enhanced professional training for researchers in the GRADE methodology. This article aims to improve the quality of evidence in SRs/MAs of animal experiments, strengthen their reliability in clinical decision-making, and promote the more efficient translation of findings from animal experiment research into clinical practice.
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.Recommendations for Standardized Reporting of Systematic Reviews and Meta-Analysis of Animal Experiments
Qingyong ZHENG ; Donghua YANG ; Zhichao MA ; Ziyu ZHOU ; Yang LU ; Jingyu WANG ; Lina XING ; Yingying KANG ; Li DU ; Chunxiang ZHAO ; Baoshan DI ; Jinhui TIAN
Laboratory Animal and Comparative Medicine 2025;45(4):496-507
Animal experiments are an essential component of life sciences and medical research. However, the external validity and reliability of individual animal studies are frequently challenged by inherent limitations such as small sample sizes, high design heterogeneity, and poor reproducibility, which impede the effective translation of research findings into clinical practice. Systematic reviews and meta-analysis represent a key methodology for integrating existing evidence and enhancing the robustness of conclusions. Currently, however, the application of systematic reviews and meta-analysis in the field of animal experiments lacks standardized guidelines for their conduct and reporting, resulting in inconsistent quality and, to some extent, diminishing their evidence value. To address this issue, this paper aims to systematically delineate the reporting process for systematic reviews and meta-analysis of animal experiments and to propose a set of standardized recommendations that are both scientific and practical. The article's scope encompasses the entire process, from the preliminary preparatory phase [including formulating the population, intervention, comparison and outcome (PICO) question, assessing feasibility, and protocol pre-registration] to the key writing points for each section of the main report. In the core methods section, the paper elaborates on how to implement literature searches, establish eligibility criteria, perform data extraction, and assess the risk of bias, based on the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) statement, in conjunction with relevant guidelines and tools such as Animal Research: Reporting of in Vivo Experiments (ARRIVE) and a risk of bias assessment tool developed by the Systematic Review Centre for Laboratory Animal Experimentation (SYRCLE). For the presentation of results, strategies are proposed for clear and transparent display using flow diagrams and tables of characteristics. The discussion section places particular emphasis on how to scientifically interpret pooled effects, thoroughly analyze sources of heterogeneity, evaluate the impact of publication bias, and cautiously discuss the validity and limitations of extrapolating findings from animal studies to clinical settings. Furthermore, this paper recommends adopting the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology to comprehensively grade the quality of evidence. Through a modular analysis of the entire reporting process, this paper aims to provide researchers in the field with a clear and practical guide, thereby promoting the standardized development of systematic reviews and meta-analysis of animal experiments and enhancing their application value in scientific decision-making and translational medicine.
5.Guideline for the workflow of clinical comprehensive evaluation of drugs
Zhengxiang LI ; Rong DUAN ; Luwen SHI ; Jinhui TIAN ; Xiaocong ZUO ; Yu ZHANG ; Lingli ZHANG ; Junhua ZHANG ; Hualin ZHENG ; Rongsheng ZHAO ; Wudong GUO ; Liyan MIAO ; Suodi ZHAI
China Pharmacy 2025;36(19):2353-2365
OBJECTIVE To standardize the main processes and related technical links of the clinical comprehensive evaluation of drugs, and provide guidance and reference for improving the quality of comprehensive evaluation evidence and its transformation and application value. METHODS The construction of Guideline for the Workflow of Clinical Comprehensive Evaluation of Drugs was based on the standard guideline formulation method of the World Health Organization (WHO), strictly followed the latest definition of guidelines by the Institute of Medicine of the National Academy of Sciences of the United States, and conformed to the six major areas of the Guideline Research and Evaluation Tool Ⅱ. Delphi method was adopted to construct the research questions; research evidence was established by applying the research methods of evidence-based medicine. The evidence quality classification system of the Chinese Evidence-Based Medicine Center was adopted for evidence classification and evaluation. The recommendation strength was determined by the recommendation strength classification standard formulated by the Oxford University Evidence-Based Medicine Center, and the recommendation opinions were formed through the expert consensus method. RESULTS & CONCLUSIONS The Guideline for the Workflow of Clinical Comprehensive Evaluation of Drugs covers 4 major categories of research questions, including topic selection, evaluation implementation, evidence evaluation, and application and transformation of results. The formulation of this guideline has standardized the technical links of the entire process of clinical comprehensive evaluation of drugs, which can effectively guide the high-quality and high-efficient development of this work, enhance the standardized output and transformation application value of evaluation evidence, and provide high-quality evidence support for the scientific decision-making of health and the rationalization of clinical medication.
6.Enhancing Disciplinary Development Through Journal Columns: Taking the "Clinical Practice Guidelines"Column in Medical Journal of Peking Union Medical College Hospital as an Example
Meihua WU ; Hui LIU ; Qi ZHOU ; Qianling SHI ; Na LI ; Yule LI ; Xiaoqing LIU ; Kehu YANG ; Jinhui TIAN ; Long GE ; Bin MA ; Xiuxia LI ; Xuping SONG ; Xiaohui WANG ; Yaolong CHEN
Medical Journal of Peking Union Medical College Hospital 2025;16(5):1315-1324
To explore the role of the "Clinical Practice Guidelines" column and others in the We collected papers published by the Lanzhou University Evidence-Based Medicine Center team in the "Clinical Practice Guidelines" column and others from 2018 to 2025. These publications were analyzed across multiple dimensions, including authorship and institutional affiliations, citation metrics, and research themes and content. A total of 59 papers were included in the analysis, with authors representing 70 domestie and international research institutions. The cumulative citation count was 639, with the highest single-paper citation frequency reaching 101. The average citation per paper was 10.8, and total downloads exceeded 30 000. The content focused on key themes such as guideline terminology, development methodology, guideline evaluation, and dissemination and implementation. The evolution of research topics progressed from critiques of common misconceptions and hot topies in the field to multidimensional evaluations of thecurrent state of Chinese guidelines, culminating in the fommulation of industry standards for guidelines. These contributions have provided critical references for translating guideline theory into practice in China and have garnered widespread attention and discussion among scholars in the field. The "Clinical Practice Guidelines" column and others in the
7.Preparation and properties of selective laser melting of porous titanium at a low energy density
Jinhui CHENG ; Quan WU ; Min PENG ; Changli HUANG ; Huimin TIAN ; Yang LI
Chinese Journal of Tissue Engineering Research 2024;28(5):664-668
BACKGROUND:At present,the traditional powder sintering method is easy to introduce impurities in the process of preparing porous titanium,and the manufacturing of porous titanium still faces two major problems:impurity pollution and difficult control of the material forming process. OBJECTIVE:To prepare pure porous titanium with certain porosity,and analyze the microstructure evolution and properties of the porous titanium. METHODS:Porous titanium was prepared at a low energy density by selective laser melting technology.The parameter range of porous titanium with large porosity was obtained by measuring the porosity of the formed specimen,and the evolution of the microstructure and mechanical properties of the specimen in the range were analyzed. RESULTS AND CONCLUSION:(1)With the increase in energy density,the porosity of the porous titanium specimen decreased gradually.When the energy density was between 10.61 and 27.78 J/mm3,porous titanium with a porosity of 11.23%-33.67%could be formed.When the energy density was between 27.78-37.88 J/mm3,the forming parts were relatively dense.(2)The phase composition of porous titanium formed was mainly α titanium.With the increase in energy density,the porosity gradually decreased,and the pore morphology changed from irregularly connected pores to closed nearly spherical pores.The powder particles changed from a slightly sintered neck to a continuous fuse.The CT scan results revealed that there were a large number of connected pores in the forming specimen with a large specific surface area and the pore radius was roughly distributed between 2-6 μm at the energy density of 10.61 J/mm3.Simultaneously,porous titanium with compressive strength of 188-1 000 MPa could be obtained at the energy density of 10.61-27.78 J/mm3,which could meet the requirements of biomedical applications.(3)These results have confirmed that the selective laser melting technology can overcome the problems of impurity pollution and long manufacturing cycle caused by the traditional preparation process,and provide an effective solution for the preparation of porous titanium with excellent mechanical properties.
8.Method for Developing Patient Decision Aid in China
Yao LU ; Qian ZHANG ; Qianji CHENG ; Jianing LIU ; Mingyao SUN ; Jinling NING ; Jiajie HUANG ; Simeng REN ; Wenzheng ZHANG ; Yajie LIU ; Xiyuan DENG ; Jinhui TIAN ; Jie LIU ; Long GE
Medical Journal of Peking Union Medical College Hospital 2024;15(6):1422-1431
To systematically construct a guideline to provide a methodological guide for researchers to develop patient decision aids. Through a literature review of international methodological guidance for developing patient decision aids, sorting out the similarities and differences in the processes and methods for developing patient decision aids, and combining them with the topic discussion of the working group, the initial guideline was drafted. A total of 13 guidances was included, with the initial version containing 3 phases, 13 steps, and 48 points. We invited 19 multidisciplinary domain experts for forming consensus. The final version of the guideline contains 3 phases, 11 steps, and 24 points. The guideline has great potential to guide the development of patient decision aids in China and is expected to fill the methodological gap in the field. In the future, several rounds of pilot testing of the guideline based on specific decision issues will be conducted, and the guideline will be further revised and improved.
9.Methods for Developing Rapid and Living Evidence-based Guidelines
Chen TIAN ; Qiuyu YANG ; Mingyao SUN ; Jie LIU ; Jinhui TIAN ; Yaolong CHEN ; Kehu YANG ; Long GE
Medical Journal of Peking Union Medical College Hospital 2024;15(1):183-191
The aims of developing rapid and living guidelines is to keep the recommendations in the guideline up-to-date. Compared with the conventional guideline, the rapid and living guideline can make better use of the existing evidence and apply and transform the evidence in a timely manner. This paper introduces the advantages and usage of rapid and living guidelines, the development process and existing challenges, and offers some insights, in order to provide reference for domestic organizations and scholars engaged in guideline development.
10.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.

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