ABSTRACT
Aim
To develop a guideline for the applicability evaluation tool of the Diagnostic Criteria for Chinese Medicine Syndromes, aiming to enhance the clinical applicability of syndrome diagnostic criteria and promote their widespread adoption and application.
Methods
This guideline was developed using the Delphi method, with reference to the Guideline on Establishing Diagnostic Criteria of Chinese Medicine Syndromes, relevant international evaluation tools, and published diagnostic criteria for Chinese medicine syndromes.
Results
The guideline specifies the principles, procedures, and scoring criteria for evaluating the applicability of traditional Chinese medicine (TCM) syndrome diagnostic criteria. The guideline consists of 5 domains and 25 items: accessibility, readability, implementability, acceptability, and overall evaluation. Each item is assessed on a 5‐point Likert scale, with higher scores indicating better applicability.
Conclusions
This guideline provides a systematic and evidence‐based framework for evaluating the applicability of diagnostic criteria for Chinese medicine syndromes. It may help improve the clinical applicability of syndrome diagnostic criteria and support their dissemination and implementation in clinical practice.
Keywords: applicability, Chinese medicine syndromes, diagnostic criteria, guideline
1. Introduction
The standardization and objectification of diagnostic criteria for Traditional Chinese Medicine (TCM) syndromes, hereafter referred to as “TCM syndrome diagnostic criteria,” are fundamental to the standardization of TCM [1]. In recent years, the standardization of TCM has advanced rapidly, and an increasing number of TCM syndrome diagnostic criteria have been published, promoting research on syndrome standardization and supporting its application in clinical practice [2, 3, 4]. However, the applicability evaluation of TCM syndrome diagnostic criteria has not received sufficient attention [5]. Existing TCM syndrome diagnostic criteria still face several challenges, including greater emphasis on development than evaluation, limited clinical use, and difficulties in dissemination and implementation [6]. Clinical applicability is a key factor influencing whether TCM syndrome diagnostic criteria can be effectively disseminated and applied in practice [7]. Therefore, after TCM syndrome diagnostic criteria have been developed, it is important to evaluate their applicability from multiple perspectives, including accessibility, readability, implementability, and acceptability [8]. At present, applicability evaluation tools have mainly been developed for clinical practice guidelines, whereas specific guidance for evaluating the applicability of TCM syndrome diagnostic criteria remains limited. Therefore, there is a need to develop a guideline for evaluating the applicability of TCM syndrome diagnostic criteria, so as to identify criteria with high clinical applicability and support the development and updating of such criteria [9, 10, 11, 12, 13].
This guideline was developed in accordance with relevant health policies, regulations, and methodological guidance. It was informed by the Guideline on Establishing Diagnostic Criteria of Traditional Chinese Medicine Syndromes (SCM 70–2022), related TCM syndrome diagnostic criteria, and existing applicability evaluation tools, while taking into account the specific characteristics of TCM syndrome diagnostic criteria. This guideline aims to improve the clinical applicability of TCM syndrome diagnostic criteria and promote their dissemination and implementation [1, 14].
2. Scope
This guideline specifies the evaluation principles, contents, scoring methods, and interpretation of standardized scores for assessing the applicability of TCM syndrome diagnostic criteria.
This guideline is intended for the applicability evaluation of published or finalized draft TCM syndrome diagnostic criteria. It may be used by guideline developers for prospective self‐assessment before publication or updating, and by external evaluators, researchers, medical institutions, or professional organizations for post‐publication assessment.
This guideline is intended for professionals in TCM, integrated traditional Chinese and Western medicine, medical education, and scientific research institutions who are involved in evaluating the applicability of TCM syndrome diagnostic criteria.(Supporting Information S1).
3. Normative References
The following documents are normatively referenced in this guideline and constitute essential provisions of this document. For dated references, only the cited edition applies. For undated references, the latest edition, including any amendments, applies.
GB/T 15657‐2021 Classification and Codes of Diseases and Syndromes in Chinese Medicine
GB/T 16751.2‐2021 Clinic Terminology of Chinese Medical Diagnosis and Treatment—Part 2: Syndromes/Patterns
GB/T 20348–2006 Basic Theory Terminology of Chinese Medicine
4. Terms and Definitions
For the purposes of this guideline, the following terms and definitions apply.
4.1. Syndrome
A syndrome refers to a pattern of clinical manifestations at a specific stage of disease. It reflects the intrinsic relationships among disease location, etiology, disease nature, disease condition, and the body's resistance to disease, and is usually expressed through clinically observable symptoms and signs (Source: ISBN 7‐03‐015154‐2, 04.548).
4.2. Applicability
Applicability refers to the extent to which a document can be appropriately used within a defined context, such as a region, institution, or user group (Source: https://g‐i‐n.net/wp‐content/uploads/2021/05/ADAPTE‐Resource‐toolkit‐V2.1‐March‐2010‐updated‐disclaimer.pdf).
5. Evaluation Principles and Process
5.1. Evaluation Principles
Evaluators should follow the principles of scientific rigor, objectivity, and impartiality. All assessments should be based on verifiable data, and the evaluation results should be traceable. It is recommended that at least three evaluators with a background in TCM independently assess the target criteria and cross‐check the results to reduce subjectivity.
5.2. Evaluation Procedures
The evaluation procedures include identification of the target TCM syndrome diagnostic criteria, assessment with the designated evaluation tool, and preparation of an evaluation report.
6. Evaluation Content and Requirements
The checklist for evaluating the applicability of TCM syndrome diagnostic criteria consists of 5 domains and 25 items: accessibility, readability, implementability, acceptability, and overall evaluation. Detailed explanations of each item are provided in Table 1.
TABLE 1.
Explanations of the items for evaluating the applicability of TCM syndrome diagnostic criteria.
| Domain | Item | Explanation |
|---|---|---|
| 1. Accessibility | ||
| The criteria are easily accessible. | Evaluate the ease of obtaining the criteria. | |
| 2. Readability | ||
| 2.1 Structure | (a) The structure is complete and reasonable. | Evaluate the completeness and rationality of the structure of the evaluation criteria. |
| (b) The diagnostic points are easy to identify. | Whether the diagnostic key points of the evaluation criteria are easy to identify, such as whether the diagnostic key points are clearly listed. | |
| (c) The development process is clear and straightforward. | Evaluate whether the development process of the criteria is clearly and completely described. | |
| 2.2 Content | (a) The content is complete and reasonable. | Evaluate the completeness and reasonableness of the content of the criteria. |
| (b) The scope of application is clear. | The scope of application of the criteria is clear, e.g. whether the target disease is specified, whether the target syndrome is specified, whether the diagnostic criteria for the syndrome or the scope of application of its specific parts are specified, etc. | |
| (c) The diagnostic points are accurately described. | Evaluate whether the diagnostic points in the criteria are accurately described, whether the syndrome classification is reasonable and whether the symptom descriptions are standardized. | |
| (d) The language is clear and standardized. | Evaluate whether the language of the criteria is clear, standardized, and appropriate, and whether the relevant terms have been standardized. | |
| (e) The content is internally consistent. | Evaluate whether the descriptions before and after are consistent, such as whether there is a contradiction between the diagnostic elements of the syndrome and the combination conditions. | |
| (f) Common syndrome classifications are included, if applicable. | For disease‐specific syndrome diagnostic criteria, evaluate whether common syndrome classifications are included, if applicable. | |
| 3. Implementability | ||
| 3.1 Clinical application characteristics | (a) The criteria are convenient for clinical application. | Evaluate the convenience of the clinical application of the criteria, e.g., whether it is time‐consuming and cumbersome to make a diagnosis with reference to the criteria. |
| (b) The criteria are accurate in clinical application. | Evaluate the accuracy of the clinical application of the criteria. | |
| (c) The consistency of clinical application is high. | Evaluate the consistency of the clinical application of the criteria, such as the consistency of diagnostic results in different clinical settings or among different physicians. | |
| 3.2 Technical level | (a) The criteria are compatible with the local medical level. | The adaptability of the evaluation criteria compared to the local medical level; whether there are difficulties in applying these criteria in the local area, such as local users generally being unable to understand the content of the criteria, or being unable to further implement treatment after differential diagnosis. |
| (b) The criteria are more standardized than other syndrome diagnostic criteria. | The superiority and normativity of the evaluation criteria compared to other criteria (or research results). | |
| 3.3 Coordination and compatibility | The criteria are consistent with the syndrome differentiation principles in diagnosis and treatment guidelines, consensus documents, protocols, and clinical pathways. | The degree of consistency between evaluation criteria and syndrome differentiation principles of diagnostic and treatment guidelines, consensus, protocol and pathways, whether there are significant discrepancies, and whether the content is coordinated and complementary. |
| 3.4 Intended effects | The criteria can improve the level of syndrome differentiation and enhance the effectiveness of diagnosis and treatment. | The role of evaluation criteria in improving syndrome differentiation level and enhancing diagnostic and therapeutic effects. |
| 3.5 Facilitators and barriers to implementation | (a) The criteria clearly describe the target users and application settings. | Whether the evaluation criteria clearly describe the applicable population and usage environment, such as for use by Chinese medicine practitioners/integrated Chinese and Western medicine practitioners/Western medicine practitioners, for use in Class III Grade A hospitals or Class III Grade B hospitals or community medical centers. |
| (b) Users can understand the criteria and have the professional competence to implement them. | Evaluate whether the users can understand the criteria content and possesses the professional capability for implementation, such as professional knowledge, clinical experience, etc. | |
| (c) Users need to receive necessary training. | Evaluate whether users need necessary training before applying the criteria. | |
| 4. Acceptability | ||
| (a) The clinical issues addressed by the criteria match those faced by users. | Whether the clinical problems addressed by the evaluation criteria match the clinical problems you are facing. | |
| (b) Users recognize the criteria. | Evaluate whether users agree with the criteria, such as the diagnostic points, etc. | |
| (c) Users are willing to refer to the criteria in their work. | Evaluate users' willingness to work clinically with reference to the criteria. | |
| 5. Overall Evaluation | ||
| (a) The clinical applicability of the criteria. | Evaluate the clinical applicability of the criteria. | |
| (b) Users’ satisfaction with the criteria and overall impression. | Evaluate your satisfaction with the criteria and overall impression. | |
6.1. Accessibility
The criteria are easily accessible.
6.2. Readability
6.2.1. Structure
(a) The structure is complete and reasonable.
(b) The diagnostic points are easy to identify.
(c) The development process is clear and straightforward.
6.2.2. Content
(a) The content is complete and reasonable.
(b) The scope of application is clear.
(c) The diagnostic points are accurately described.
(d) The language is clear and standardized.
(e) The content is internally consistent.
(f) Common syndrome classifications are included, if applicable.
6.3. Implementability
6.3.1. Clinical Application Characteristics
(a) The criteria are convenient for clinical application.
(b) The criteria are accurate in clinical application.
(c) The consistency of clinical application is high.
6.3.2. Technical Level
(a) The criteria are compatible with the local medical level.
(b) The criteria are more standardized than other syndrome diagnostic criteria.
6.3.3. Coordination and Compatibility
The criteria are consistent with the syndrome differentiation principles in diagnosis and treatment guidelines, consensus documents, protocols, and clinical pathways.
6.3.4. Intended Effects
The criteria can improve the level of syndrome differentiation and enhance the effectiveness of diagnosis and treatment.
6.3.5. Facilitators and Barriers to Implementation
(a) The criteria clearly describe the target users and application settings.
(b) Users can understand the criteria and have the professional competence to implement them.
(c) Users need to receive necessary training.
6.4. Acceptability
(a) The clinical issues addressed by the criteria match those faced by users.
(b) Users recognize the criteria.
(c) Users are willing to refer to the criteria in their work.
6.5. Overall Evaluation
(a) The clinical applicability of the criteria.
(b) Users’ satisfaction with the criteria and overall impression.
7. Scoring Methods
Each item is assessed on a 5‐point Likert scale ranging from 1 to 5, with higher scores indicating better applicability of the TCM syndrome diagnostic criteria for that item. The scoring methods and criteria are presented in Table 2.
TABLE 2.
Scoring methods and criteria for evaluating the applicability of TCM syndrome diagnostic criteria.
| Domain | Items | ||||
|---|---|---|---|---|---|
| 1. Accessibility (The syndrome criteria are easily accessible.) | The criteria are easily accessible. | ||||
| 1 | 2 | 3 | 4 | 5 | |
| □ Not easy | □ Not very easy | □ Neutral | □ Relatively easy | □ Very easy | |
| 2. Readability (Being able to understand the syndrome criteria) | 2.1 Structure | ||||
| a) The criteria are complete and reasonable; | |||||
| 1 | 2 | 3 | 4 | 5 | |
| □ Incomplete, unreasonable | □ Not very complete, reasonable | □ Neutral | □ Relatively complete, reasonable | □ Very complete, reasonable | |
| b) The diagnostic points are easy to identify; | |||||
| 1 | 2 | 3 | 4 | 5 | |
| □ Not easy | □ Not very easy | □ Neutral | □ Relatively easy | □ Very easy | |
| c) The development process is clear and straightforward. | |||||
| 1 | 2 | 4 | 5 | ||
| □ Unclear | □ Not very clear | □ Neutral | □ Quite clear | □ Very clear | |
| 2.2 Content | |||||
| a) The content is complete and reasonable; | |||||
| 1 | 2 | 3 | 4 | 5 | |
| □ Incomplete, unreasonable | □ Not very complete, reasonable | □ Neutral | □ Relatively complete, reasonable | □ Very complete, reasonable | |
| b) The scope of application is clear; | |||||
| 1 | 2 | 3 | 4 | 5 | |
| □ Unclear | □ Not very clear | □ Neutral | □ Quite clear | □ Very clear | |
| c) Diagnostic points are accurately described; | |||||
| 1 | 2 | 3 | 4 | 5 | |
| □ Inaccurate | □ Not very accurate | □ Neutral | □ Quite accurate | □ Very accurate | |
| d) The language is clear and standardized; | |||||
| 1 | 2 | 3 | 4 | 5 | |
| □ Unclear, non‐standard | □ Not very clear, standard | □ Neutral | □ Relatively clear, standard | □ Very clear, standard | |
| e) The content is consistent; | |||||
| 1 | 2 | 3 | 4 | 5 | |
| □ Inconsistent | □ Slightly consistent | □ Neutral | □ Mostly consistent | □ Completely consistent | |
| f) Common syndrome classifications (if applicable) are included. | |||||
| 1 | 2 | 3 | 4 | 5 | |
| □ Not included | □ Partially included | □ Neutral | □ Mostly included | □ Fully included | |
| 3. Implementability (Implementation of the criteria) | 3.1 Clinical application characteristics | ||||
| a) The clinical application is convenient; | |||||
| 1 | 2 | 3 | 4 | 5 | |
| □ Not convenient | □ Not very convenient | □ Neutral | □ Relatively convenient | □ Very convenient | |
| b) The clinical application is accurate; | |||||
| 1 | 2 | 3 | 4 | 5 | |
| □ Inaccurate | □ Not very accurate | □ Neutral | □ Quite accurate | □ Very accurate | |
| c) The consistency of clinical application is high. | |||||
| 1 | 2 | 3 | 4 | 5 | |
| □ Low consistency | □ Lower consistency | □ Neutral | □ Higher consistency | □ High consistency | |
| 3.2 Technical level | |||||
| a) The criteria are compatible with the local medical level; | |||||
| 1 | 2 | 3 | 4 | 5 | |
| □ Not adapted | □ Not very adapted | □ Neutral | □ Relatively adapted | □ Very adapted | |
| b) It's standardized compared to other syndrome diagnostic criteria. | |||||
| 1 | 2 | 3 | 4 | 5 | |
| □ Completely behind | □ Relatively behind | □ Neutral | □ Relatively superior | □ Completely superior | |
| 3.3 Coordination and compatibility | |||||
| The criteria are consistent with the syndrome differentiation principles in diagnosis and treatment guidelines, consensus documents, protocols, and clinical pathways. | |||||
| 1 | 2 | 3 | 4 | 5 | |
| □ Not a match | □ Not quite a match | □ Neutral | □ Fairly matched | □ Very matched | |
| 3.4 Intended effects | |||||
| The criteria can improve the level of syndrome differentiation and enhance the effectiveness of diagnosis and treatment. | |||||
| 1 | 2 | 3 | 4 | 5 | |
| □ Not obvious | □ Not very obvious | □ Neutral | □ Quite obvious | □ Very obvious | |
| 3.5 Facilitators and barriers to implementation | |||||
| a) The criteria clearly describe the target users and application settings; | |||||
| 1 | 2 | 3 | 4 | 5 | |
| □ Unclear | □ Not very clear | □ Neutral | □ Quite clear | □ Very clear | |
| b) Users can understand the criteria and have the professional competence to implement them. | |||||
| 1 | 2 | 3 | 4 | 5 | |
| □ Not equipped | □ Not very equipped | □ Neutral | □ Relatively equipped | □ Very equipped | |
| c) Users need to receive the necessary training | |||||
| 1 | 2 | 3 | 4 | 5 | |
| □ Very necessary | □ Somewhat necessary | □ Neutral | □ Not very necessary | □ Not necessary | |
| 4. Acceptability (Agree with the syndrome diagnosis content of this criteria) | a) The clinical issues addressed by the criteria match those faced by users. | ||||
| 1 | 2 | 3 | 4 | 5 | |
| □ Low consistency | □ Lower consistency | □ Neutral | □ Higher consistency | □ High consistency | |
| b) Users recognize of the criteria. | |||||
| 1 | 2 | 3 | 4 | 5 | |
| □ Disagree | □ Somewhat disagree | □ Neutral | □ Somewhat agree | □ Completely agree | |
| c) Users willingness to refer to the criteria in their work. | |||||
| 1 | 2 | 3 | 4 | 5 | |
| □ Unwilling | □ Not very willing | □ Neutral | □ Quite willing | □ Very willing | |
| 5. Overall evaluation | a) The clinical applicability of the criteria. | ||||
| 1 | 2 | 3 | 4 | 5 | |
| □ Not applicable | □ Not very applicable | □ Neutral | □ Relatively applicable | □ Very applicable | |
| b) Your satisfaction with the criteria and overall impression. | |||||
| 1 | 2 | 3 | 4 | 5 | |
| □ Dissatisfied | □ Slightly Dissatisfied | □ Neutral | □ Quite Satisfied | □ Very Satisfied | |
7.1. Domain Standardized Score Calculation Method
Domain Standardized Score = (Sum of all evaluators’ scores for the domain − Minimum possible score for the domain)/(Maximum possible score for the domain − Minimum possible score for the domain) × 100.
7.2. Overall Standardized Score Calculation Method
Overall Standardized Score = (Sum of all evaluators’ overall scores − Minimum possible overall score)/(Maximum possible overall score − Minimum possible overall score) × 100.
Funding
The study was supported by the first batch of top talent training program (Yucai Xing [2024] No. 3), National Natural Science Foundation of China Key Project (81830116), and Research Special Project for the “Double First‐Class” Construction of Traditional Chinese Medicine in Henan Province (HSRP‐DFCTCM‐2023‐2‐01)
Conflicts of Interest
The authors declare no conflicts of interest.
Supporting information
Supporting Information: jebm70153‐sup‐0001‐SuppMat.docx
1. Guideline Group
The main drafting organizations include:
Henan University of Chinese Medicine, The First Affiliated Hospital of Henan University of Chinese Medicine
The participating drafting organizations
Beijing University of Chinese Medicine, Dongzhimen Hospital of Beijing University of Chinese Medicine, China Academy of Chinese Medical Sciences, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong Provincial Hospital of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Lanzhou University, West China Hospital of Sichuan University, Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Hong Kong Baptist University, Liverpool School of Tropical Medicine, Alberta Health Services Data Analytics Centre, Chinese Medicine Association of Australia.
The main drafters
Jiansheng Li, Yang Xie, Siyuan Lei, Jiajia Wang, Yue Yuan.
Participating drafters of the guidelines (listed in the order of the number of srokes in the surname)
China: Changhe Yu, Tianfang Wang, Xiaohui Wang, Nannan Shi, Aiping Lv (Hong Kong China), Liang Du, Bo Li, Darong Wu, Xiaobo Yang, Kehu Yang, Jianping Liu, Mengyu Liu, Xincan Liu, Shengsheng Zhang, Mingyan Zhang, Junhua Zhang, Wei Chen, Yaolong Chen, Yutong Fei, Zhengkun Hou, Siyuan Hu, Jianyuan Tang, Rui Gao, Long Ge, Xing Liao.
UK: Tao Chen.
Canada: Guanmin Chen.
Australia: Guoqing Wei, Jianhua Zheng.
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Supplementary Materials
Supporting Information: jebm70153‐sup‐0001‐SuppMat.docx