This paper investigates the theoretical and methodological frameworks for adapting international evidence-based guidelines within integrated healthcare systems that merge Western medicine with traditional healing practices. It explores five key domains of guideline adaptation. First, it examines the necessity of cultural localization due to fundamental differences in healthcare values, decision-making paradigms, and medical epistemologies. Second, it analyzes methodological frameworks for guideline adaptation, emphasizing culturally progressive strategies that uphold scientific rigor while enhancing cultural relevance. Third, it reviews case studies of localized implementation, with a focus on diabetic foot care, to illustrate integration techniques for harmonizing divergent medical traditions. Fourth, comprehensive strategies for developing derivative products encompass de novo development and adaptation pathways, including patient guidelines and decision aids. Fifth, the implementation and de-implementation strategies are informed by behavioral change theories, particularly the capability-opportunity-motivation-behavior (COM-B) model. These investigations culminate in a proposed Clinical Transformation Model, which synthesizes the knowledge-to-action (KTA) framework with the COM-B model to create an integrated approach to cross-cultural guideline adaptation. This model establishes a structured methodology for adapting international guidelines to diverse healthcare settings while preserving local medical traditions. Future research directions include exploring the role of artificial intelligence in evidence translation, particularly within integrated medical systems. This study enhances the understanding of cross-cultural knowledge translation processes and provides methodological insights into the implementation of global evidence-based practices.

Introduction Threatened miscarriage is a common complication of pregnancy occurring in 20% of all clinically recognized pregnancies, and about half will eventually result in complete pregnancy loss. But current treatment of threatened miscarriage showed no benefit when compared with placebo. Our aim is to investigate the effectiveness and safety of Chinese herbal medicine (CHM) and/or oral micronized progesterone (OP) in women presenting with threatened miscarriage. The new “Shoutai Wan” (NSTW) granule CHM is used. Methods This is a multicenter, randomized, placebo-controlled factorial trial with a 2 by 2 design. It is currently being conducted at 22 sites in mainland China. We plan to enroll women with threatened miscarriage at 5-10 gestational weeks. After screening, randomized assignment will be conducted for eligible women by a computer generated random block format in a 1:1:1:1 ratio into one of four groups: 1) CHM and OP; 2) CHM placebo and OP; 3) CHM and OP placebo, and 4) CHM placebo and OP placebo. Depending on the gestational age at randomization, the medication will be administered for 2-7 weeks, ending at 12 weeks gestation. The primary outcome measure is live birth. Secondary outcomes are: 1) pregnancy outcomes, including rate of sustained ongoing pregnancy rate, miscarriage, stillbirth, induced abortion, preterm birth, extreme preterm birth, full-term birth, post-term birth, and delivery gestational age; 2) neonatal outcomes, including rate of small for gestational age, large for gestational age, congenital malformations and birth weight; and 3) maternal outcomes, including score change of SF-12 Health Survey Scale, Zung Self-Rating Anxiety Scale, and Traditional Chinese Medicine Symptom Score. The sample size is 1656 participants. Discussion This trial is expected to provide strong evidence regarding the efficacy of CHM and OP for threatened miscarriage management. Trial registration The trial is registered at clinicaltrials.gov (approval no.: NCT02633878). Last refreshed on October 31, 2024.

Introduction Heart failure (HF) is a significant global health issue. There is an ongoing need for early detection and monitoring of its severity, which remains a critical and unmet requirement. Inspection diagnosis in traditional Chinese Medicine (TCM) is a method of assessing the condition of the internal zang-fu organs by observing the body's external manifestations, offering a promising approach to this issue. In this study, we aimed to systematically evaluate the existing research on the correlation between TCM diagnostic inspection and HF, using an evidence map to uncover potential research directions in this domain. Methods A comprehensive literature search was conducted across several databases, including the China National Knowledge Infrastructure (CNKI), Wanfang Database, Chinese Scientific Journal Database (VIP), PubMed, and Web of Science. The search screened clinical studies, systematic reviews, guidelines, and clinical pathways relevant to diagnostic inspection and HF. The collected data were analyzed using graphical and textual representations to delineate the distribution and characteristics of the evidence. Results Overall, 33 studies, comprising 14 cross-sectional, 8 cohort, and 11 case-control studies, were included in the analysis. The clinical research output showed consistent growth between 1992 and 2024, with 70% of the investigations enrolling ≤300 participants. The primary focus of these studies was chronic HF (10 studies, 30.3%). Regarding diagnostic approaches, 26.47% used visual assessment and 61.76% used device-based methods. Inspection diagnosis played several roles in HF management, predominantly facilitating disease risk prediction (15 studies, 45.45%) and disease severity evaluation (14 studies, 42.42%). Conclusion Observational evidence from TCM inspection diagnoses, especially regarding retinal/fundus and tongue manifestations, indicates that it may be of possible prognostic use. However, this needs to be confirmed through high-quality prospective studies, which should also validate the auxiliary role of inspection diagnoses in preventing and treating HF.

Introduction Cupping mark color is believed to be related to the mechanism and efficacy of cupping therapy, but exploration of the factors influencing its depth has so far been limited. Methods We recruited 100 patients with fibromyalgia and 100 healthy volunteers (aged 18-75 years) from Dongfang Hospital Beijing University of Chinese Medicine (Beijing, China), and nearby communities. A survey was conducted to collect demographic data and the Traditional Chinese Medicine (TCM) constitution of participants. Cupping was then performed at six acupoints (bilateral Feishu [BL 13], Xinshu [BL 15], and Ganshu [BL 18]) for 10 min, and the resulting color of each cupping mark was rated according to a cupping color rating chart. Statistical multiple linear regression analysis was carried out using SPSS 22.0 to determine the correlation between cupping mark color and possible influencing factors including health status, TCM constitution type, sex, age, and body mass index (BMI). Results A total of 33 males (16.5%) and 167 females (83.5%), with an average age of 42.08 years, completed the survey. Forty-four participants (22%) were classified as yang-deficiency constitution, 38 (19%) as balanced constitution, and 26 (13%) as phlegm-dampness constitution. The average score of cupping mark color was 4.38. Sex (β = −1.025, P = 0.001) and health status (β = −0.678, P = 0.003) were significant factors influencing cupping mark color: female participants had lighter marks than males, and fibromyalgia patients had lighter marks than healthy volunteers. TCM constitution type, age, and BMI were not associated with cupping mark color. Conclusions This cross-sectional study of 200 participants did not reveal any correlation between TCM constitution type and cupping mark color. However, given the limited sample size, future studies with larger cohorts are warranted.

Introduction Dysphagia is a common post-stroke complication. Acupuncture is a widely used effective treatment for post-stroke dysphagia in China. Based on our previously published overview in 2019, this study aimed to provide an update on the current evidence regarding acupuncture for post-stroke dysphagia. Specifically, this study aimed to assess the quality of systematic reviews (SRs) and meta-analyses (MAs) published in the last 5 years using the new Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 (PRISMA 2020) tool to provide updated evidence for clinical decision-making. Methods The following databases were searched: China National Knowledge Infrastructure, Wanfang database, Chinese Scientific Journal Database, SinoMed, PubMed, Embase and Cochrane Library from January 1, 2019 to June 30, 2025. Two researchers independently performed data extraction. A Measurement Tool to Assess Systematic Reviews 2 (AMSTAR 2) and PRISMA 2020 were used to evaluate the methodological and reporting quality of the included SRs/MA, respectively. Results Eight SRs/MA met the inclusion criteria. Additionally, one article applied the Grading of Recommendations Assessment, Development Evaluation system. Most of the evidence was of very low quality, with the primary factors for downgrading being inconsistency and publication bias. Evaluation using AMSTAR 2 indicated that there were no high-quality SRs/MA and that all studies were of critically low quality. Quality issues included failure to provide a list of excluded studies and justify their exclusion. Moreover, not all studies were randomized controlled trials (RCTs) with a low risk of bias (RoB). Additionally, if the studies were RCTs with moderate or high risk of bias, the review did not provide a discussion of the likely impact of the RoB on the results. Conclusion Acupuncture combined with rehabilitation may improve post-stroke dysphagia symptoms. However, the methodological quality of SRs/MA remains very low and has not improved over the last 5 years. Studies should be designed in line with the AMSTAR 2 and PRISMA 2020 to provide reliable, high-quality evidence for supporting clinical practice.

Introduction Traditional, complementary, and integrative medicine (TCIM) therapies include those typically considered outside of the purview of conventional medicine. Sharing study materials and data is crucial for enhancing transparency, reproducibility, and data use for secondary data analyses in TCIM research. This cross-sectional study aims to assess the extent to which TCIM study materials and data are made publicly available. Methods We will analyze a sample of 400 published TCIM research articles including primary studies (e.g. clinical trials, observational studies, and qualitative research), as well as evidence synthesis studies (e.g., systematic reviews and scoping reviews), which are informed by systematic searches. In analyzing these studies, we aim to assess whether and how researchers shared the data and materials they generated or used in their work, including details on how to access them. This study will be conducted by searching the MEDLINE database using the “Complementary Therapies” medical subject heading; records will be screened for eligibility then a sample of eligible articles will be selected at random. Discussion The findings and observations from this analysis will provide insights into current practices and highlight areas for improvement in the transparency and accessibility of TCIM research.

Introduction With the adoption of international health standards, patient-reported outcomes (PROs) are increasingly used in clinical trials, promoting the effective implementation of patient-centered healthcare. However, the characteristics of PRO use in digestive tract tumor trials in China remain poorly understood. The aim of this study was to evaluate PRO application and characteristics in randomized clinical trials of digestive tract tumors conducted in China. Methods In this cross-sectional study, we identified data from the ClinicalTrials.gov database and the Chinese Clinical Trial Registry and the dataset was restricted to randomized clinical trials of digestive tract tumors conducted in China between January 1, 2010, and June 30, 2025. Trials were classified into four groups: (1) those listing PROs as primary outcomes; (2) those listing PROs as secondary outcomes; (3) trials listing PROs as co-primary outcomes (both primary and secondary); and (4) trials without any PRO instrument. Results Of 2292 trials, 928 (40.5%) incorporated PRO instruments as part of their results. Among these, 29.6% (275/928) listed PRO as primary outcomes, 54.2% (503/928) as secondary outcomes, and 16.2% (150/928) as co-primary outcomes. The most frequent conditions for the explicit use of specific PRO instruments included colorectal (405/928, 43.6%), stomach (229/928, 24.7%), and esophageal (166/928, 17.9%) tumors. Commonly used PRO instruments included the Visual Analog Scale, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30, and the Numeric Rating scale. Among relevant trials, only 4.8% (6/125) used the traditional Chinese medicine (TCM) Symptom Score. Conclusions Recently, PRO use has shown an increasing trend in randomized clinical trials on digestive tract tumors conducted in China. Nonetheless, the low proportion of clinical trials of digestive tract tumors using PROs remains noteworthy. Future efforts should develop TCM-specific PRO tools and integrate TCM syndrome scales with Western PROs in TCM-oncology trials.