1.Construction of the Theoretical Model of the "Manipulative Effect Units" and Its Application in Complex Interventions of Manual Medicine
Yanan SUN ; Qun NIU ; Changhe YU
Journal of Traditional Chinese Medicine 2026;67(13):1365-1372
Drawing on the concepts of behavioural change taxonomies and theoretical coding schemes, this paper designs a theoretical model of "manipulative effect units" for manual medicine, establishing a logical framework that links "treatment objectives (theory-driven)-treatment techniques (precise implementation)-expected effects (immediate verification)". First, it analyses the methodological challenges faced by manual medicine as a complex intervention, reviewing the insights and limitations of existing research frameworks. It then focuses on the model's core concepts, theoretical architecture and multi-level coding system of "manipulative effect units", illustrating its application logic using tuina for knee osteoarthritis as an example. Finally, it proposes a development pathway of "manipulative effect units" model in complex interventions based on consensus, technological integration and artificial intelligence. This model aims to provide a unified methodological foundation for the standardised description, reproducible research and identification of active components in manual interventions, thereby propelling manual medicine from empirical transmission towards a new phase guided by theory and evidence optimization.
2.Construction of a Dual-dimensional Outcome System for Musculoskeletal Pain:A Common Core Outcome Set and A Specific Outcome Set for Traditional Chinese Medicine External Treatment
Yuanwen LIANG ; Hong CHEN ; Yanan SUN ; Changhe YU
Journal of Traditional Chinese Medicine 2026;67(14):1503-1508
ObjectiveTo develop a core outcome set for musculoskeletal pain (MKP-COS) and a specific outcome set for traditional Chinese medicine external treatment (MKP-SOS-ETCM), providing a standardized basis for clinical research in musculoskeletal pain and serving as a reference for core outcome set (COS) development in related fields. MethodsExisting COS studies on musculoskeletal pain (MKP) were systematically searched, and core outcome indicators were extracted to form an initial item pool. The Delphi method was used, in which experts were invited to reach consensus on MKP-COS and MKP-SOS-ETCM. The inclusion criteria for consensus are set as an importance score of 7-9 points with ≥75% of experts reaching agreement. ResultsA total of 47 COS studies were included, and after discussion and consolidation, a preliminary item pool containing 34 outcome indicators was established. After three rounds of Delphi expert consensus, MKP-COS was identified, including five outcomes including pain, motor function, joint range of motion, activities of daily living, and adverse events/ adverse reactions; MKP-SOS-ETCM included six outcomes involving stiffness (including morning stiffness), joint tenderness count, work status/ productivity, overall physician assessment, structural damage, and muscle strength. ConclusionThis study has established MKP-COS and MKP-SOS-ETCM, forming a dual-dimensional outcome assessment system integrating both disease commonality and intervention specificity.
3.Construction of a Dual-dimensional Outcome System for Musculoskeletal Pain:A Common Core Outcome Set and A Specific Outcome Set for Traditional Chinese Medicine External Treatment
Yuanwen LIANG ; Hong CHEN ; Yanan SUN ; Changhe YU
Journal of Traditional Chinese Medicine 2026;67(14):1503-1508
ObjectiveTo develop a core outcome set for musculoskeletal pain (MKP-COS) and a specific outcome set for traditional Chinese medicine external treatment (MKP-SOS-ETCM), providing a standardized basis for clinical research in musculoskeletal pain and serving as a reference for core outcome set (COS) development in related fields. MethodsExisting COS studies on musculoskeletal pain (MKP) were systematically searched, and core outcome indicators were extracted to form an initial item pool. The Delphi method was used, in which experts were invited to reach consensus on MKP-COS and MKP-SOS-ETCM. The inclusion criteria for consensus are set as an importance score of 7-9 points with ≥75% of experts reaching agreement. ResultsA total of 47 COS studies were included, and after discussion and consolidation, a preliminary item pool containing 34 outcome indicators was established. After three rounds of Delphi expert consensus, MKP-COS was identified, including five outcomes including pain, motor function, joint range of motion, activities of daily living, and adverse events/ adverse reactions; MKP-SOS-ETCM included six outcomes involving stiffness (including morning stiffness), joint tenderness count, work status/ productivity, overall physician assessment, structural damage, and muscle strength. ConclusionThis study has established MKP-COS and MKP-SOS-ETCM, forming a dual-dimensional outcome assessment system integrating both disease commonality and intervention specificity.
4.Reporting Status of Adverse Events during Tuina and the Construction of a Systematic Safety Management System
Qun NIU ; Xiyou WANG ; Changhe YU
Journal of Traditional Chinese Medicine 2026;67(16):1723-1727
The field of tuina therapy currently faces several systemic challenges, including the lack of standar-dized definitions and classification criteria for adverse events and reactions, low awareness of proactive reporting, and the absence of a national-level monitoring system. These gaps lead to an underestimation of its true safety risks associated with tuina, thereby impeding the standardization and modernization of the discipline. Based on a thorough analysis of potential risks across the entire tuina treatment process, this paper proposes a comprehensive "four-pillar" safety management framework. This framework encompasses a standardized terminology and grading system, a mandatory national registry system, a big data-driven analytical and intelligent early-warning system, and a safety education system integrated throughout the treatment pathway. This framework aims to provide theoretical support and practical pathways to enhance the safety of tuina and to promote the evidence-based development and internationalization of the field.
5.Constructing an integrative Chinese and western medical clinical pathway for knee osteoarthritis based on guideline recommendations
Luping LIU ; Xiyou WANG ; Lingyun ZHANG ; Yuan LEI ; Yi AN ; Yixuan GAO ; Zhendong XING ; Jiaqi LIU ; Changhe YU
International Journal of Traditional Chinese Medicine 2025;47(1):9-17
Knee osteoarthritis (KOA) is a common chronic degenerative disease that not only causes pain and reduces the quality of life for patients but also imposes a significant societal burden. Clinical pathways can be developed by referencing recommendations from clinical practice guidelines to localize guidelines within the context of integrated traditional Chinese and western medical systems. However, existing clinical pathways suffer from shortcomings such as deficiencies in integrated traditional Chinese and western medical diagnosis and treatment, inadequate shared decision-making between healthcare providers and patients, and suboptimal visualization of clinical pathways. This study aimed to address and optimize the clinical pathway of KOA by comprehensively organizing and localizing the recommended guidelines. The concept of integrated traditional Chinese and western medicine was reflected through the construction of a path of joint decision-making between doctors and patients, emphasizing the coexistence of diagnosis and screening, the combination of clinical and imaging staging, joint decision-making between doctors and patients, and treatment stages. This pathway emphasizes patient-centered approach, with pain relief and functional rehabilitation running parallel, achieving the implementation of evidence-based concepts in practical medical practice. It provides a concrete basis for joint decision-making between doctors and patients in the integrated treatment of KOA with traditional Chinese and western medicine, which helps to improve diagnosis and treatment efficiency and patient quality of life.
6.Exploration of the effect and design of placebo manipulation in clinical trials of manipulation
Changhe YU ; Hualong LU ; Zhifeng LIU ; Hui SHAO ; Baolin JIA ; Hao WANG ; Xiyou WANG ; Yanan SUN
International Journal of Traditional Chinese Medicine 2025;47(10):1353-1358
This article summarized the current status and challenges of manipulation therapy for musculoskeletal pain and its placebo effect in clinical trials, analyzing the impact of the placebo effect on the evaluation of therapeutic efficacy. The efficacy of different manual manipulation techniques remains uncertain, and the degree of blinding and patient expectations play a crucial role in efficacy assessment. The article suggested improving trial design through standardized placebo intervention design, comprehensive investigation of patient expectations and psychological states, rigorous training of practitioners, and optimized diagnostic and treatment scenarios and doctor-patient relationship, to ensure consistency between intervention and placebo groups. Specific measures include the application of the DITTO (Deconstruct, Identify, Take out, Think, Optimize) framework, the use of standardized questionnaire tools, and multi-center, large-sample randomized controlled trials to enhance the external validity and statistical power of research results, thereby providing more scientifically reliable evidence for clinical practice.
7.Placebo effect in manual therapy: mechanism, influencing factors, and clinical application
Changhe YU ; Hui SHAO ; Xiyou WANG ; Yanan SUN
International Journal of Traditional Chinese Medicine 2025;47(11):1493-1498
The placebo effect in manual therapy is analyzed, suggesting that it is not only a control tool in experiments but also a key to the success of manual therapy. By analyzing the impact of multiple dimensions of the placebo effect, such as psychological and social factors, behavioral responses, and expectation effects, on treatment outcomes, it is pointed out that the professional image of the therapist and the patients' positive expectations of the treatment are the core elements to activate the placebo effect. At the same time, individual differences in treatment responses are also emphasized as a crucial aspect that cannot be ignored. It is suggested to reposition the placebo effect, incorporate it into the overall framework of manual therapy, and further explore its mechanism to provide a theoretical basis for the scientific and precise development of manual therapy.
8.Thoughts on optimization of STRICTOTM checklist to improve the implementation and reporting quality of Tuina massage clinical trials
Changhe YU ; Hao WANG ; Xiyou WANG ; Yanan SUN
International Journal of Traditional Chinese Medicine 2025;47(12):1645-1651
Tuina massage, as a TCM therapy, plays an important role in the treatment and rehabilitation of various diseases. However, the quality of Tuina massage clinical trials is directly affected by the design, implementation, and reporting quality of the treatment plan. STRICTOTM checklist, developed based on the CONSORT statement, is specifically designed for the reporting of intervention measures in Tuina massage clinical trials. However, there are many problems in its application, such as insufficient guidance on the design of treatment plans, unclear requirements for the control and recording of implementation details, and insufficiently detailed and standardized reporting information. This article reviewed the existing problems in the STRICTOTM checklist through the results of previous studies on the influencing factors of Tuina clinical trials and proposed potential methods and content for improvement. Specifically, this includes refining the assessment of treatment rationality, enriching the description of intervention details, strengthening the consideration of prognostic factors, paying attention to the impact of contextual factors, standardizing sham Tuina control, and enhancing the reporting of implementation fidelity. It is hoped that these improvements and optimization measures will enhance the quality of Tuina massage clinical trial reporting, ensure the transparency and repeatability of the research, and provide important references for the development of Tuina massage clinical research and the optimization of clinical decision-making.
9.Analysis on negative conversion of syphilis-specific antibody and related factors in children born to pregnant women with syphilis in China, 2021
Hongqiao ZHENG ; Ailing WANG ; Xiaoyan WANG ; Qian WANG ; Shuiling QU ; Dongxu HUANG ; Yu WANG ; Changhe WANG
Chinese Journal of Epidemiology 2025;46(5):784-788
Objective:To understand the negative conversion of syphilis-specific antibody in follow-up in 0-18 months-old children born to pregnant women with syphilis in China in 2021 and analyze the related factors.Methods:The basic information of pregnant women with syphilis and follow-up information of their children in 2021 were extracted from the National Management Information System for the Prevention of mother-to-child transmission of HIV, syphilis and Hepatitis B. The logistic regression model was used to analyze related factors of negative conversion of syphilis-specific antibody.Results:In 2021, a total of 34 201 children was delivered by syphilis-infected pregnant women, and 23 592 (68.98%) children were included in this study. Negative conversion of syphilis-specific antibody occurred in 21 076 (89.34%) children, but not in 2 516 (10.66%) children. Multivariate logistic regression analysis identified several factors associated with a higher probability of the negative conversion of syphilis-specific antibody: prophylactic benzathine penicillin injection at birth (a OR=1.35,95% CI:1.10-1.65), mother's age 26-30 years (a OR=1.22,95% CI:1.01-1.46), 36-40 years (a OR=1.34, 95% CI:1.09-1.64), other ethnic groups (a OR=1.19,95% CI:1.04-1.36), non-syphilis-specific antibody titers less than 1∶8 during pregnancy (a OR=1.56,95% CI:1.37-1.78), penicillin treatment (a OR=1.56,95% CI:1.23-1.98) and standardized treatment (a OR=1.21,95% CI:1.11-1.32). Conclusions:In 2021,the level of syphilitic-specific antibody negative conversion in follow-up in children born to pregnant women with syphilis was high in China. According to the factors associated with syphilis-specific antibody negative conversion, it is necessary to develop the follow-up strategies for the children born to pregnant women.
10.Cross-sectional study of drug resistance in newly diagnosed HIV-1 infected patients in Shanghai
Qianru LIN ; Xuqin WANG ; Wenqi TANG ; Yuan DONG ; Qing YUE ; Chunyan HE ; Xiaolei YU ; Changhe LIU ; Yiqing HAN ; Wanqing FENG ; Zhen NING ; Xin SHEN ; Xin CHEN ; Yi LIN
Chinese Journal of Experimental and Clinical Virology 2025;39(1):69-74
Objective:To investigate the drug resistance of newly diagnosed HIV-1 infected patients in Shanghai and to provide reference value for clinical antiretroviral therapy (ART).Methods:The peripheral venous blood plasma of 196 newly diagnosed HIV-1 infected patients screened according to the inclusion and exclusion criteria at the Shanghai Public Health Clinical Center from April to June 2023 was collected, HIV-1 RNA was extracted, the pol region was amplified by reverse transcription-polymerase chain reaction (RT-PCR) for sequencing, the mutation sites and ART drug resistance were analyzed.Results:The plasma of 196 newly diagnosed HIV-1 infected patients was amplified successfully in 162 cases (amplification success rate was 82.65%). The subtypes consisted of CRF07_BC(51.23%), CRF01_AE (27.78%), and others (6.79%), CRF55_01B (5.56%), B (3.70%), CRF01_AE/B (3.70%) and CRF08_BC (1.23%). The overall transmitted drug resistance rate was 7.41%, the protease inhibitors (PIs), non-nucleoside/nucleotide reverse transcriptase inhibitors (NNRTIs), nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs), integrase inhibitors (INSTIs) resistance rates were 3.09%, 3.70%, 0.00% and 0.62%, respectively. The proportion of NNRTIs-related mutation sites in B (66.67%) and CRF55_01B (88.89%) was higher than that in CRF07_BC (13.25%); the proportion of NNRTIs-related mutation sites in CRF55_01B (88.89%) was higher than that in CRF01_AE (22.22%) and other subtypes (18.18%), the difference was statistically significant (all P<0.05). Multivariate logistic regression analysis showed that the probability of PIs-related mutation sites in CRF01_AE/B was 21.71 times that of CRF07_BC[odds ratio ( OR)=21.71, 95% confidence interval ( CI): 3.36-140.27, P=0.001]. Conclusions:The transmitted drug resistance among newly diagnosed HIV-1 infected patients in Shanghai is at the moderate epidemic level, mainly NNRTIs and PIs-related drug resistance, and the INSTIs resistance rate is low, the use of INSTIs in ART regimens should be considered.

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