The paper reviews the status quo of international, national, industry, and association standards of acupuncture-moxibustion devices and provides the suggestion and optimization from the perspective of standard system construction and industrial coordination. The current challenges include: ① Imbalanced structure in standard system: international standards outnumber domestic ones. ② Mismatched industrial demand with standard supply: traditional instrument standards lag behind industrial upgrading demands, while the absence of standards for new instruments hampers innovations. ③ Key stakeholders are underrepresented, showing the insufficient participation from enterprises as core users and weak foundational research in standardization. ④ Insufficient strategic design: there is a lack of effective coordination among competent authorities and insufficient in the top-level design for international standards. To address these issues, the systematic optimization and suggestion are proposed: ① Systematically optimizing the standard system, establishing an applicable evaluation framework, and exploring the converting mechanisms of domestic and international standards. ② In organization, deepening industry investigation and enterprise-standard collaboration while strengthening standardization promotion. ③ In strategy, improving mid-to-long term planning for international standards and focusing on key technological fields. This study aims to enhance the standard system of acupuncture-moxibustion devices, support industrial upgrading and improve international standard influence through innovative standard development methodology and collaborative governance model.
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The expert consensus on the clinical treatment of herpes zoster with fire needling was developed, and the commonly used fire needling treatment scheme verified by clinical research was selected to form a standardized diagnosis and treatment scheme for acute herpes zoster and postherpetic neuralgia (PHN), so as to answer the core problems in clinical application. The consensus focuses on patients with herpes zoster, and forms recommendations for 9 key clinical issues, covering simple fire needling and TCM comprehensive therapy based on fire needling, including fire needling combined with cupping, fire needling combined with Chinese herb, fire needling combined with cupping and Chinese herb, fire needling combined with filiform needling, fire needling combined with moxibustion, and provides specific recommendations and operational guidelines for various therapies.
To develop the clinical questions and outcomes of Clinical Practice Guideline of Fire Needling Therapy for Herpes Zosters based on Norms of Formulation and Evaluation for the Clinical Guideline on Acupuncture and Moxibustion released by World Federation of Acupuncture and Moxibustion Societies.
Combined the investigation with expert consultation and consensus method, and taken clinicians (members) of Chinese Association of Acupuncture and Moxibustion as the subjects, the clinical questions concerned were collected and the two-round consultation was conducted among expert group by letter. In the first round questionnaire, using the voting method, the relevant clinical questions in intervention measures were collected; and in the second round, with the Delphi method adopted, the importance of clinical questions and outcomes in the investigation was scored.
A total of 200 structured clinical questions proposed by 153clinicians and the clinical experience with 13 kinds of combined therapies involved and fire needling as the key measure were collected. The authority coefficient (Cr) of the Delphi questionnaire was>0.70, and the coefficient of variation for the importance scores of alternative clinical questions and outcomes was 0.06-0.26 and 0.12-0.47, respectively. The top 10 clinical questions and 12 outcomes (6 outcomes referred to the patients either in the acute stage or the post-neuralgia stage) were included, with the importance score of clinical questions>4, the importance score of outcomes>6, and the coefficient of variation ≤0.25.
The clinical questions and outcomes of Clinical Practice Guideline of Fire Needling Therapy for Herpes Zosters are formulated, which provides the research basis for the recommendation development of the guideline.
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