1.Methodology for Developing Patient Guideline (3):Reporting Frameworks and Presentation
Lijiao YAN ; Ning LIANG ; Haili ZHANG ; Nannan SHI ; Ziyu TIAN ; Ruixiang WANG ; Xiaojia NI ; Yufang HAO ; Wei CHEN ; Yingfeng ZHOU ; Dan YANG ; Shuyu YANG ; Yujing ZHANG ; Ziteng HU ; Jianping LIU
Journal of Traditional Chinese Medicine 2024;65(22):2304-2309
Standardized reporting is a crucial factor affecting the use of patient guidelines (PGs), particularly in the reporting and presentation of recommendations. This paper introduced the current status of PG reporting, including the research on PG content and presentation formats, and provided comprehensive recommendations for PG reporting from aspects such as overall framework, recommendations, presentation format, and readability. First, the presentation of PG recommendations should include clearly defined clinical questions, recommendations and their rationale, and guidance on how patients should implement the interventions; for specific content in the PG, such as level of evidence, level of recommendation, it is recommended to explain in text the reasons for giving different levels of recommendation, i.e., to present the logic behind giving the level of recommendation to the patient; additional information needed in the recommendation framework should be supplemented by tracing references or authoritative textbooks and literature that support the recommendations. Subsequently, the PG text should be written based on the Reporting Checklist for Public Versions of Guidelines (RIGHT-PVG) reporting framework. Finally, to enhance readability and comprehension, it is recommended to refer to the Patient Education Materials Assessment Tool (PEMAT) for translating PG content. To enhance the readability of PGs, it is suggested to present the PG content in a persona-lized and layered manner.
2.Methodology for Developing Patient Guideline(1):The Concept of Patient Guideline
Lijiao YAN ; Ning LIANG ; Ziyu TIAN ; Nannan SHI ; Sihong YANG ; Yufang HAO ; Wei CHEN ; Xiaojia NI ; Yingfeng ZHOU ; Ruixiang WANG ; Zeyu YU ; Shuyu YANG ; Yujing ZHANG ; Ziteng HU ; Jianping LIU
Journal of Traditional Chinese Medicine 2024;65(20):2086-2091
Since the concept of patient versions of guidelines (PVGs) was introduced into China, several PVGs have been published in China, but we found that there is a big difference between the concept of PVG at home and abroad, and the reason for this difference has not been reasonably explained, which has led to ambiguity and even misapplication of the PVG concept by guideline developers. By analyzing the background and purpose of PVGs, and the understanding of the PVG concept by domestic scholars, we proposed the term patient guidelines (PGs). This refers to guidelines developed under the principles of evidence-based medicine, centered on health issues that concern patients, and based on the best available evidence, intended for patient use. Except for the general attribute of providing information or education, which is typical of common health education materials, PGs also provide recommendations and assist in decision-making, so PGs include both the patient versions of guidelines (PVG) as defined by the Guidelines International Network (GIN) and "patient-directed guidelines", i.e. clinical practice guidelines resulting from the adaptation or reformulation of recommendations through clinical practice guidelines.
3.Methodology for Developing Patient Guideline (2):Process and Methodology
Lijiao YAN ; Ning LIANG ; Nannan SHI ; Sihong YANG ; Ziyu TIAN ; Dan YANG ; Xiaojia NI ; Yufang HAO ; Wei CHEN ; Ruixiang WANG ; Yingfeng ZHOU ; Shibing LIANG ; Shuyu YANG ; Yujing ZHANG ; Ziteng HU ; Jianping LIU
Journal of Traditional Chinese Medicine 2024;65(21):2194-2198
At present, the process and methodology of patient guidelines (PGs) development varies greatly and lacks systematic and standardised guidance. In addition to the interviews with PG developers, we have sorted out the relevant methodology for the adaptation and development of existing clinical practice guideline recommendations and facilitated expert deliberations to achieve a consensus, so as to finally put forward a proposal for guidance on the process and methodology for the development of PGs. The development of PGs can be divided into the preparation stage, the construction stage, and the completion stage in general, but the specific steps vary according to the different modes of development of PGs. The development process of Model 1 is basically the same as the patient version of the guideline development process provided by the International Guidelines Network, i.e., team formation, screening of recommendations, guideline drafing, user testing and feedback, approval and dissemination. The developer should also first determine the need for and scope of translating the clinical practice guideline into a patient version during the preparation phase. Model 2 adds user experience and feedback to the conventional clinical practice guideline development process (forming a team, determining the scope of the PG, searching, evaluating and integrating evidence, forming recommendations, writing the guideline, and expert review). Based on the different models, we sort out the process and methods of PG development and introduce the specific methods of PG development, including how to identify the clinical problem and how to form recommendations based on the existing clinical practice guidelines, with a view to providing reference for guideline developers and related researchers.
4.Methodology for the Development of Clinical Practice Guidelines for Chinese Patent Medicine(Part 5): Retrieval and Synthesis of Key Information on Rational Drug Use
Ziteng HU ; Ning LIANG ; Lijiao YAN ; Yujing ZHANG ; Fuqiang ZHANG ; Yaxin CHEN ; Bin LIU ; Qianzi CHE ; Yixiang LI ; Jing GUO ; Nannan SHI ; Yanping WANG
Journal of Traditional Chinese Medicine 2024;65(2):167-171
Recommendations for Chinese patent medicine (CPM) based on key information on rational drug use are one of the important conditions for enhancing guideline enforceability as well as facilitating guideline implementation. In this study, we discussed in detail of the key information on the rational use of CPM in five aspects, which are dosage, drug discontinuation, drug-drug and drug-food interactions, safety and economy. Following the process of multi-source search, synthesis and prioritization, it is suggested to collect key information on the rational use of CPM from a multi-source search of drug instructions, policy documents, literature, and clinical experts' experiences. Then the searched information should be summarized and prioritized with the principle that taking drug instructions as the basis and other-sources information for check and supplementation. Finally, methodological recommendations for the retrieval and synthesis of key information on rational drug use in guideline recommendations has been formed.
5.Methodology for the Development of Clinical Practice Guidelines for Chinese Patent Medicine (Part 6): Formation and Presentation of Recommendations
Yujing ZHANG ; Ning LIANG ; Lijiao YAN ; Ziteng HU ; Yaxin CHEN ; Fuqiang ZHANG ; Qianzi CHE ; Zhao CHEN ; Yuqi LIU ; Dingyi WANG ; Nannan SHI ; Yanping WANG
Journal of Traditional Chinese Medicine 2024;65(2):172-177
Recommendation formation is a key component of clinical practice guidelines for Chinese patent medicine (CPM), and should encompass the determination of the strength and direction of the recommendation, the rationale for the recommendation, and the methodology for implementing the recommendation. Recommendations can be formed through formal consensus and informal consensus. The strength and direction of recommendations for CPM guidelines should be determined by considering the quality of evidence for CPMs, the priority of the clinical questions, the pros and cons of efficacy and adverse effects, patient acceptance, the feasibility of the recommendation and the availability of resources, social fairness, economic benefits, and other influencing factors. In order to better guide guideline developers to consider these factors more rationally, this article provideed a detailed explanation of each factor in the context of the characteristics of TCM.
6.Methodology for the Development of Clinical Practice Guidelines for Chinese Patent Medicine (Part 7): Introduction and Interpretation of the Guideline Reporting Checklist
Yujing ZHANG ; Fuqiang ZHANG ; Lijiao YAN ; Ziteng HU ; Yaxin CHEN ; Haili ZHANG ; Huizhen LI ; Qianzi CHE ; Ning LIANG ; Nannan SHI ; Yanping WANG
Journal of Traditional Chinese Medicine 2024;65(2):178-184
The systematic and comprehensive introduction and interpretation of the Reporting Checklist of Clinical Practice Guidelines for Chinese Patent Medicines V1.0 is conducive to the presentation of high-quality clinical practice guidelines for Chinese patent medicines (CPMs), thus improving their dissemination and use. The Reporting Checklist of Clinical Practice Guidelines for Chinese Patent Medicines V1.0 specifies the requirements for clear, complete and transparent reporting of the whole process of developing CPMs guidelines, containing 4 domains, 17 topics and 43 items, and involving the basic information, recommendations and methods of guideline development. Especially, it details the items related to the rules and regulations of the use of CPMs in the recommendations, which is helpful for improving the completeness, scientificity and practicality of the reporting of CPMs guideline.
7.Methodology for the Development of Clinical Practice Guidelines for Chinese Patent Medicine (Part 8): Quality Evaluation with AGREE Ⅱ and RIGHT
Fuqiang ZHANG ; Ziteng HU ; Yujing ZHANG ; Lijiao YAN ; Juyi WANG ; Cehan ZHANG ; Jiaqi CHEN ; Mengyi WANG ; Shuoming LIU ; Xinyi XIE ; Ning LIANG ; Nannan SHI ; Yanping WANG
Journal of Traditional Chinese Medicine 2024;65(2):185-191
ObjectiveTo evaluate the methodological and reporting quality of clinical practice guidelines for Chinese patent medicine (CPM) with internationally recognized tools the appraisal of guidelines for research and evaluation (AGEREE) Ⅱ and reporting items for practice guidelines in healthcare (RIGHT), thereby providing refe-rence for the clinical application and future development of CPM guidelines. MethodsDatabases including CNKI, VIP, Wanfang and Sinomed were searched for CPM guidelines, as well as medlive.cn, websites of China Association of Chinese Medicine and Chinese Medical Association, and reference lists of the included papers. The quality of the guidelines was evaluated using the AGREE Ⅱand RIGHT tools, and consistency tests were performed using Interclass Correlation Coefficient, and descriptive analysis and chi-square test were used to analyze the reporting rate for each domain and the average score for each item. ResultsFinally, 140 CPM guidelines were included, of which 51 were disease-oriented and 89 were drug-oriented, all of which were issued by China. For 51 disease-oriented CPM guidelines, the highest average score of all six AGREE Ⅱ domains was 73.32% for clarity, and the lowest was 26.80% for application; for 89 drug-oriented CPM guidelines, the highest average score was 55.62% for scope and purpose, and the lowest was 31.32% for rigour of development. In terms of the seven domains of the RIGHT checklist, the highest reporting rate was 68.26% for background, and lowest was 27.45% for other areas regarding the disease-oriented CPM guidelines; the highest reporting rate was 61.31% for background, and the lowest was 4.49% for other areas regarding drug-oriented CPM guidelines. The average reporting rate was higher for disease-oriented than drug-oriented CPM guidelines in three domains of AGREE Ⅱ (rigour of development, clarity of presentation, editorial independence), as well as four domains of RIGHT checklist (basic information, evidence, funding and declaration and management of interests, and other areas). ConclusionThe overall methodology and reporting quality of the current CPM guidelines still need to be improved. It is recommended that future guideline development teams should strictly refer to the AGREE Ⅱ and RIGHT checklist, and take into account of the characteristics of CPM guidelines and relevant methodo-logical suggestions in the development and reporting of CPM guidelines, thereby guiding the clinical use of CPM in a better way.
8.Methodology for Developing Rapid and Living Guidelines of Traditional Chinese Medicine (RALIG-TCM) (Part 1):Concept and Current Practice
Lijiao YAN ; Ning LIANG ; Ziteng HU ; Yujing ZHANG ; Yaxin CHEN ; Fuqiang ZHANG ; Xiaoling LI ; Wenjie CAO ; Chen ZHAO ; Cheng LYU ; Nannan SHI ; Yanping WANG
Journal of Traditional Chinese Medicine 2024;65(3):269-274
Rapid and living guidelines are those developed in response to public health emergencies in a short period of time using a scientific and standardized approach. Subsequently, they provide timely and credible recommendations for decision makers through regular and frequent updates of clinical evidence and recommendations. In this paper, we introduced the definition of rapid and living guideline as well as analyzed the basic characteristics of eight rapid and living guidelines in the field of traditional Chinese medicine (TCM) published till 2023 June, summarizing three core methodological issues in relation to how to rapidly develop guidelines, how to formulate recommendations when there is lack of evidence, and how to ensure the timeliness of guidelines. Based on the analysis of current rapid and living guidelines, it is implicated that there is necessity to carry out rapid and living guideline in the field of TCM, and the methodology of rapid integration of multivariate evidence in the field of TCM needs to be further explored; furthermore, it is necessary to further explore the obstacles of implementation of guidelines and promote timely updating, all of which provide certain theoretical references for relevant guideline developers and researchers.
9.Methodology for Developing Rapid and Living Guidelines of Traditional Chinese Medicine (RALIG-TCM) (Part 2): Development Process and Key Steps during Preparation Stage
Yujing ZHANG ; Lijiao YAN ; Ziteng HU ; Yaxin CHEN ; Xiaoling LI ; Qianzi CHE ; Jingya WANG ; An LI ; Nannan SHI ; Yanping WANG ; Ning LIANG
Journal of Traditional Chinese Medicine 2024;65(3):275-280
It is necessary to develop rapid and living guidelines in order to improve the evidence translation and guidance for clinical practice in emergency situations, and to enhance the participation of traditional Chinese medicine (TCM) in management of emergencies. This paper introduced the process of developing rapid and living guidelines of TCM and divided it into three stages, that is preparation, rapid development and dynamic updating, which highlights the features of rapid development, high quality, and dynamic updating and the integration with the predominance of TCM. By comparing with general guidelines on composition, personnel number, timing to formulate and communication patterns of the guideline working groups, as well as the content and number of clinical questions, this paper mainly gave suggestions on how to formulate a concise but authoritative team during the preparation stage, how to efficiently manage the guideline team and promote the development process from conflict of interest management, working and communication mode adjustment, and how to formulate and update the important and prioritized clinical questions, all of which may provide reference for the development of TCM rapid and living guidelines.
10.Methodology for Developing Rapid and Living Guidelines of Traditional Chinese Medicine (RALIG-TCM) (Part 3): Rapid Evidence Collection, Integration and Recommendation Formation
Ziteng HU ; Lijiao YAN ; Yujing ZHANG ; Yaxin CHEN ; Xiaoling LI ; Haili ZHANG ; Huizhen LI ; Jingya WANG ; An LI ; Zhao CHEN ; Ning LIANG ; Nannan SHI ; Yanping WANG
Journal of Traditional Chinese Medicine 2024;65(3):281-286
The lack of direct evidence is an important problem faced in the formation of recommendations in rapid living guidelines of traditional Chinese medicine under public health emergencies, and the supplementation of indirect evidence can be a key method to solve this problem. For the collection of evidence, the type of evidence required, including direct and indirect evidence, should be clarified, and ‘direct first’ principle for selecting evidence can be set to standardize and accelerate the guideline development. When integrating evidence, recommendations can be formed directly if there is sufficient direct evidence, while regarding insufficient direct evidence, recommendations need to be supplemented and improved by integrating indirect evidence. In addition, when the body of evidence contains evidence from multiple sources, it is suggested to rate the evidence according to “higher rather than lower” principle. Finally, when forming recommendations, the level of evidence, safety and economic efficiency should be taken into consideration to determine the strength of the recommendation.

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