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.

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.

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.

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.

Efficacy evaluation of TCM syndromes is a core aspect of validating the clinical effectiveness of TCM.However,consensus has yet to be established regarding its conceptual definition,measurement tools,and methodological framework.This article reviewed the current state of research in TCM syndrome efficacy evaluation:Conceptually,there is a need to clarify the distinction between broad(encompassing all outcome measures highlighting the efficacy of treatment based on syndrome differentiation)and narrow(limited to syndrome-related indicators)definitions;in terms of content and methodology,it is essential to integrate macro-and micro-level indicator systems,standardize evaluation models that either combine or separate disease and syndrome diagnosis,and address the characteristics of dynamism,individualization,and holism;regarding measurement,challenges such as interference from disease factors and insufficient indicator matching persist in the development of scales,objectification of the four diagnostic methods(inspection,listening and smelling,inquiry,pulse-taking),and construction of mathematical models still exist.Future research directions may focus on the following:Enhancing a people-centered evaluation process through"co-construction by practitioners and patients";Establishing a primary framework centered on"guiding disease treatment by syndrome differentiation"to promote the quantification and precision of syndrome indicators(e.g.,state-target syndrome differentiation);Integrating multiple data sources to construct an evidence-based comprehensive evaluation system.By standardizing definitions,innovating tools,and integrating methodologies,the standardization and precision of TCM pattern efficacy evaluation research can be advanced.

Objective To analyze the methodology and reporting quality of acupuncture related randomized controlled trials(RCTs)in order to provide a basis for improving the design and reporting of acupuncture studies.Methods Literatures on RCTs included in acupuncture were obtained from two systematic reviews of acupuncture studies.Two reviewers were selected independently according to the exclusion criteria,and RoB2.0,CONSORT statement and STRICTA criteria were used to evaluate the methodology and report quality.Results 95 literatures on acupuncture RCTs were included,including 51 in Chinese and 44 in English,involving 38 diseases and 54 outcome indicators.CONSORT declared that there were 8 items with high reporting rate,15 items with low reporting rate and 2 items with medium reporting rate in the evaluation.The STRICTA criteria included 8 items with high reporting rate,4 items with low reporting rate,and 4 items with medium reporting rate.As for RoB2.0 bias risk assessment,11.6%of the literature in the overall bias area that served as a summary was high risk,50.5%was likely risk,and 37.9%was low risk.Conclusion The current published RCTs research methodology and report quality evaluation are not high,the future research should improve the scientific and rigorous program design,to form a transparent and complete research report.

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.

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.

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.

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.