To interpret the evidence-to-decision （EtD） framework and to illustrate its application in traditional Chinese medicine （TCM） guideline development using the example of the Pharmacovigilance Guideline of Chinese Patent Medicine， thereby providing methodological references for TCM guideline standardization. Based on the core three stages of the EtD framework （formulating the question， making an assessment of the evidence， and drawing conclusions）， critical decision points and evaluation evidence within the evidence-translation process were systematically addressed， aligning with the purpose， scope， and key questions of the guideline. Qualitative research methods， such as the nominal group technique， were employed to formulate recommendations. The analysis was conducted based on the EtD framework. During question formulation， the specific characteristics and practical needs of pharmacovigilance for Chinese patent medicines were clarified， focusing on the core objective of safety assurance throughout the product lifecycle. In the evidence assessment， multi-source evidence was integrated， including policy documents， literature research， and expert consensus， completing the evidence evaluation. Finally， in recommendation-forming， dispersed research evidence and expert experience were synthesized into consensus， culminating in the guideline's completion through solicitation of opinions and peer review. The EtD framework provides a structured tool for evidence-to-decision translation in TCM guideline development， effectively enhancing the transparency and scientific rigor of the process. Therefore， it is recommended that TCM guideline development adopt the EtD framework to improve the evidence-to-decision process with TCM characteristics.

The Guidelines for Construction of Traditional Chinese Medicine Pharmacovigilance Systems in Medical Institutions （T/CACM 1563.2-2024） were the first special guideline in China to systematically assist medical institutions in establishing a pharmacovigilance system tailored to the characteristics of traditional Chinese medicine （TCM）. This guideline was jointly developed with 23 authoritative medical and research institutions in China， under the lead of the Institute of Basic Clinical Medicine， China Academy of Chinese Medical Sciences. The purpose of this guideline was to standardize pharmacovigilance work throughout the entire lifecycle of TCM （including research and development， marketing， and application） and to establish a four-dimensional framework of "organizational structure， institutional system， information platform， and vigilance activities". Key components included the establishment of a TCM Safety Committee， the construction of nine core systems， the development of an information platform that complies with International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use （ICH） E2B standards， alongside the risk monitoring， identification， assessment， and control during clinical trials and post-marketing phases. Therefore， this guideline filled a significant gap in the systemic standards for TCM safety management within medical institutions. Strictly adhering to domestic and international laws and regulations， the guideline compilation involved multiple rounds of expert interviews， systematic evidence integration， and broad consensus. This guideline was specified to be applicable to medical institutions at all levels， primarily addressing core issues， including the difficulty in adverse reaction identification， low reporting rates， and incomplete risk management chains due to the complex composition and diverse application of TCM. The compilation process was scientific and rigorous， ensuring alignment with current national laws and regulations， and was registered internationally. In the future， implementation will be promoted through standardized training， tiered dissemination， as well as a post-effect evaluation and dynamic revision mechanism starting two years after publication. All these aimed to enhance medical institutions' proactive capabilities in preventing and controlling TCM safety risks， ensure patient medication safety， and promote the high-quality development of TCM.

To standardize the clinical application of oral Chinese patent medicines （CPMs）， and address the safety issues arising from their dosage form characteristics， irrational clinical use， and the lack of targeted pharmacovigilance systems， the China Association of Chinese Medicine organized the formulation and release of Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines， aiming to inform the safe clinical use of oral CPMs and related pharmacovigilance work. According to the principles of GB/T1.1—2020 and the Drug Administration Law of the People's Republic of China （2019 revision）， the Institute of Basic Research in Clinical Medicine， China Academy of Chinese Medical Sciences， led a drafting group comprising 18 institutions. After multiple rounds of expert interviews， literature retrieval， evidence screening， and extensive solicitation of opinions， the Guidelines were registered internationally. Systematic standardization focused on safety monitoring， risk identification， assessment， control， and other aspects. The Guidelines clarified the characteristics of oral CPMs in terms of safety monitoring， known risks， and potential risks， compared to non-oral CPMs. Then， risk control measures were proposed， including medication in special populations and irrational medication. As a special guideline for pharmacovigilance in the clinical application of oral CPMs， the Guidelines systematically construct a technical system in line with the characteristics of traditional Chinese medicine （TCM）， which is essential for improving the clinical safety management of oral CPMs and provides an important reference for medical institutions， pharmaceutical manufacturers， and regulatory authorities.

To interpret the evidence-to-decision （EtD） framework and to illustrate its application in traditional Chinese medicine （TCM） guideline development using the example of the Pharmacovigilance Guideline of Chinese Patent Medicine， thereby providing methodological references for TCM guideline standardization. Based on the core three stages of the EtD framework （formulating the question， making an assessment of the evidence， and drawing conclusions）， critical decision points and evaluation evidence within the evidence-translation process were systematically addressed， aligning with the purpose， scope， and key questions of the guideline. Qualitative research methods， such as the nominal group technique， were employed to formulate recommendations. The analysis was conducted based on the EtD framework. During question formulation， the specific characteristics and practical needs of pharmacovigilance for Chinese patent medicines were clarified， focusing on the core objective of safety assurance throughout the product lifecycle. In the evidence assessment， multi-source evidence was integrated， including policy documents， literature research， and expert consensus， completing the evidence evaluation. Finally， in recommendation-forming， dispersed research evidence and expert experience were synthesized into consensus， culminating in the guideline's completion through solicitation of opinions and peer review. The EtD framework provides a structured tool for evidence-to-decision translation in TCM guideline development， effectively enhancing the transparency and scientific rigor of the process. Therefore， it is recommended that TCM guideline development adopt the EtD framework to improve the evidence-to-decision process with TCM characteristics.

The Guidelines for Construction of Traditional Chinese Medicine Pharmacovigilance Systems in Medical Institutions （T/CACM 1563.2-2024） were the first special guideline in China to systematically assist medical institutions in establishing a pharmacovigilance system tailored to the characteristics of traditional Chinese medicine （TCM）. This guideline was jointly developed with 23 authoritative medical and research institutions in China， under the lead of the Institute of Basic Clinical Medicine， China Academy of Chinese Medical Sciences. The purpose of this guideline was to standardize pharmacovigilance work throughout the entire lifecycle of TCM （including research and development， marketing， and application） and to establish a four-dimensional framework of "organizational structure， institutional system， information platform， and vigilance activities". Key components included the establishment of a TCM Safety Committee， the construction of nine core systems， the development of an information platform that complies with International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use （ICH） E2B standards， alongside the risk monitoring， identification， assessment， and control during clinical trials and post-marketing phases. Therefore， this guideline filled a significant gap in the systemic standards for TCM safety management within medical institutions. Strictly adhering to domestic and international laws and regulations， the guideline compilation involved multiple rounds of expert interviews， systematic evidence integration， and broad consensus. This guideline was specified to be applicable to medical institutions at all levels， primarily addressing core issues， including the difficulty in adverse reaction identification， low reporting rates， and incomplete risk management chains due to the complex composition and diverse application of TCM. The compilation process was scientific and rigorous， ensuring alignment with current national laws and regulations， and was registered internationally. In the future， implementation will be promoted through standardized training， tiered dissemination， as well as a post-effect evaluation and dynamic revision mechanism starting two years after publication. All these aimed to enhance medical institutions' proactive capabilities in preventing and controlling TCM safety risks， ensure patient medication safety， and promote the high-quality development of TCM.

To standardize the clinical application of oral Chinese patent medicines （CPMs）， and address the safety issues arising from their dosage form characteristics， irrational clinical use， and the lack of targeted pharmacovigilance systems， the China Association of Chinese Medicine organized the formulation and release of Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines， aiming to inform the safe clinical use of oral CPMs and related pharmacovigilance work. According to the principles of GB/T1.1—2020 and the Drug Administration Law of the People's Republic of China （2019 revision）， the Institute of Basic Research in Clinical Medicine， China Academy of Chinese Medical Sciences， led a drafting group comprising 18 institutions. After multiple rounds of expert interviews， literature retrieval， evidence screening， and extensive solicitation of opinions， the Guidelines were registered internationally. Systematic standardization focused on safety monitoring， risk identification， assessment， control， and other aspects. The Guidelines clarified the characteristics of oral CPMs in terms of safety monitoring， known risks， and potential risks， compared to non-oral CPMs. Then， risk control measures were proposed， including medication in special populations and irrational medication. As a special guideline for pharmacovigilance in the clinical application of oral CPMs， the Guidelines systematically construct a technical system in line with the characteristics of traditional Chinese medicine （TCM）， which is essential for improving the clinical safety management of oral CPMs and provides an important reference for medical institutions， pharmaceutical manufacturers， and regulatory authorities.

Objective:To investigate the predictive value of tumor morphology in hepatoce-llular carcinoma (HCC) immunotherapy.Methods:The propensity score matching and retrospective cohort study was conducted. The clinical data of 227 HCC patients who underwent immunotherapy in The First Affiliated Hospital of University of Science and Technology of China from January 2021 to December 2023 were collected. There were 203 males and 24 females, aged (57±11)years. Of the 227 patients, 93 patients with regular tumor morphology of HCC evaluated by computed tomography (CT) or magnetic resonance imaging (MRI) were divided into the regular morphology group, and 134 patients with irregular tumor morphology of HCC evaluated by CT or MRI were divided into the irregular morphology group. Observation indicators: (1) propensity score matching and comparison of general data of patients between the two groups after matching; (2) analysis of factors affecting prognosis of patients; (3) prognosis of patients after propensity score matching. Comparison of measurement data with normal distribution between groups was conducted using the independent sample t test. Comparison of count data between groups was conducted using the chi-square test. Comparison of ordinal data was conducted using the Mann-Whitney U test. The Kaplan-Meier method was used to calculate survival rate and draw survival curve. The Log-rank test was used for survival analysis. The Cox proportional hazards regression model was used for univariate and multivariate analyses. Propensity score matching was done by the 1∶1 nearest neighbor matching method, with a caliper value of 0.02. Results:(1) Propensity score matching and comparison of general data of patients between the two groups after matching. Of 227 HCC patients undergoing immunotherapy, 164 cases were successfully matched, including 82 cases in the regular morphology group and 82 cases in the irregular morphology group. After propensity score matching, the elimination of patients who underwent radical surgical resection in the past, tumor number and alpha fetoprotein confounding bias ensured comparability between the two groups. (2) Analysis of factors affecting prognosis of patients. Results of multivariate analysis showed that body mass index ≥25 kg/m 2 and irregular tumor morphology were independent risk factors affecting overall survival time of patients ( hazard ratio=0.891, 1.870, 95% confidence interval as 0.825-0.963, 1.151-3.038, P<0.05). (3) Prognosis of patients after propensity score matching. After propensity score matching, the median progression-free survival time was 11.9(95% confidence interval as 9.2-16.1)months for patients in the regular tumor morphology group and 6.4(95% confidence interval as 4.4-8.1)months for patients in the irregular tumor morphology group, the 1-year progress-free survival rate was 48.48% for patients in the regular tumor morphology group and 22.25% for patients in the irregular tumor morphology group. There was a significant difference in progress-free survival between patients in the regular tumor morphology group and the irregular tumor morphology group ( χ2=16.000, P<0.05). The median overall survival time was 27.2(95% confidence interval as 23.7-not reached)months for patients in the regular tumor morphology group and 18.1 (95% confidence interval as 15.8-20.8)months for patients in the regular tumor morphology group, the 1-year overall survival rate was 83.27% for patients in the regular tumor morphology group and 66.98% for patients in the irregular tumor morphology group. There was a significant difference in overall survival between patients in the regular tumor morphology group and the irregular tumor morphology group ( χ2=13.400, P<0.05). Conclusions:Tumor morphology has a predictive value for the efficacy of immunotherapy for HCC. Compared with HCC patients of regular tumor morphology, immunotherapy is less effective in patients with irregular tumor morphology.

Biliary tract carcinoma (BTC), characterized by high heterogeneity, exhibits rapid progression and poor prognosis. Its diagnosis requires comprehensively evaluation of clinical manifestation, laboratory index, graphics and pathology. Patients of early-stage BTC may achieve fortunate cure through comprehensive treatment primarily centered on surgery. However, for patients of advanced BTC, main treatment modalities include chemotherapy, targeted therapy, and immunotherapy, yet single-agent therapies have limited effectiveness, with systemic treatment being predominantly used. In the view of authors, with the deep exploration and breakthroughs of immune combination therapies in clinical research, immunotherapy is emerging as a novel research hotspot and primary treatment strategy in the field of BTC therapy, marking a new era in diagnostic and therapeutic strategies for patients with BTC.

Objective:To develop the Amputation Scale for Severe Open Pelvic Fractures and explore its application value in patients with severe open pelvic fractures.Methods:A total of 27 patients with severe open pelvic fractures who underwent surgical treatment in Shandong Provincial Hospital Affiliated to Shandong First Medical University from January 2010 to January 2023 were retrospectively analyzed. There were 15 males and 12 females, aged 38.6±11.6 years (range, 13-65 years). There were 13 cases of traffic injuries, 10 cases of fall from height injuries, and 4 cases of mechanical crushing injuries; 20 cases were admitted to the hospital in emergency, and 7 cases were transferred from other hospitals. All fracture types were Tile C, including 14 cases of Tile C1, 8 cases of Tile C2, and 5 cases of Tile C3. There were 16 cases of genitourinary system injury, 8 cases of anal or rectal injury, 12 cases of abdominal injury, 9 cases of chest injury, and 6 cases of craniocerebral trauma. The mangled extremity severity score (MESS) and the Amputation Scale for Severe Open Pelvic Fractures were used to evaluate whether amputation was performed. The sensitivity, specificity, positive predictive value, negative predictive value and accuracy of the two evaluation methods were calculated.Results:Among the 27 patients, 21 cases were treated with pelvic external fixator to control the volume, 16 cases were treated with gauze packing to stop bleeding, 8 cases were treated with temporary abdominal aorta occlusion, and 12 cases were treated with laparotomy because of abdominal injury. Seven of the 27 patients died, with a mortality rate of 26%. In 12 cases of one-stage amputation, 3 cases died, including 1 case died of multiple organ failure syndrome, 1 case died of gastrointestinal bleeding on the 7th day after amputation, and 1 case died of severe infection on the 4th day after amputation. Among the 15 cases of one-stage limb salvage, 4 cases died, of which 2 cases of second-stage amputation died of infection on the 5th day after one-stage limb salvage, and 1 case of one-stage limb salvage died of limb necrosis on the 3rd day after one-stage limb salvage. Two patients died of multiple organ failure syndrome. The MESS score of 27 patients was 6(6, 8) points (range, 6-13 points), and the Amputation Scale for Severe Open Pelvic Fractures score was 9.6±1.8 points (range, 6-14 points). The sensitivity, specificity, positive predictive value, negative predictive value and accuracy of MESS were 66.7%, 50%, 40%, 75% and 56%, respectively, while those of Amputation Scale for Severe Open Pelvic Fractures were 80%, 89%, 73%, 88% and 82%, respectively. The specificity and accuracy of MESS were significantly lower than those of Amputation Scale for Severe Open Pelvic Fractures ( P<0.05). All 20 patients who survived were followed up for 23.6±7.5 months (range, 11-37 months). Five cases had soft tissue infection at the stump of amputation, which were treated with debridement, and 3 cases underwent skin grafting, and the stump healed well at the last follow-up. Conclusion:The Amputation Scale for Severe Open Pelvic Fractures is better than MESS in the assessment of early amputation in patients with severe pelvic fractures.

Objective:To investigate the clinical efficacy of open arthrolysis in the treatment of posttraumatic elbow stiffness.Methods:A retrospective analysis was conducted on the data of 407 patients with post-traumatic elbow stiffness treated by open arthrolysis surgery in Shandong Provincial Hospital from January 2010 to January 2024. The cohort included 303 males and 104 females, with a mean age of 38.98±10.90 years (range, 18-72 years) and mean body mass index (BMI) of 24.32±3.29 kg/m 2 (range, 17.91-33.41 kg/m 2). There were 230 patients with right-sided elbow stiffness, 159 patients with left-sided elbow stiffness, and 18 patients with bilateral elbow stiffness. Initial injuries included 21 patients of isolated elbow dislocation; 25 patients of soft tissue injury; and 361 patients of initial intra-articular elbow fractures, among which there were 200 patients of multiple fractures, 87 patients of single distal humerus fracture, 43 patients of single proximal ulna fracture, and 31 patients of single radial head fracture. Initial injuries were treated non-surgically in 69 cases and surgically in 338 cases, among which 177 cases were retained with internal fixation. There were 334 preoperative patients complicated with heterotopic ossification and 73 patients without heterotopic ossification, with 99 patients undergoing early release (stiffness duration <6 months) and 308 patients undergoing late release (stiffness duration ≥6 months). Record the range of motion (ROM) of the elbow joint, forearm rotational range (FRR), visual analogue scale (VAS), Mayo elbow performance score (MEPS), modified Broberg-Morrey score (MBS), Oxford elbow score (OES), and disability of arm, shoulder and hand (DASH) score before and after surgery, and conduct comparative analysis. Results:All patients were followed up for an average of 41.86±10.27 months (range, 13-119 months). At 12 months postoperatively, elbow ROM improved from preoperative 33.7°±26.5° to 101.2°±24.0°, elbow FRR improved from preoperative 101.4°±53.5° to 138.9°±38.7°, the MEPS increased from 60.1±14.7 to 91.5±10.1, the BMS increased from 57.5±12.8 to 83.7±11.0, the OES decreased from 31.6±7.3 to 16.0± 4.6, the DASH score decreased from 38.8±13.9 to 10.1±9.5, and the VAS decreased from 3.0±2.3 to 0.9±1.1, with all changes showing statistical significance ( P<0.05). In patients with preoperative heterotopic ossification, postoperative mean flexion range was 120.1°±15.5° and elbow ROM was 102.6°±23.4°. In patients without preoperative heterotopic ossification, postoperative mean flexion range was 113.9°±15.6° and elbow ROM was 93.4°±26.4°. Statistically significant differences were observed between the two groups in postoperative flexion range and flexion-extension ROM. There were no statistically significant differences in the postoperative above-mentioned indicators between early and late release patients ( P>0.05). The supination range and elbow FRR in patients with multiple fractures were lower than those in patients with distal humerus fractures and proximal ulna fractures; the DASH score in patients with multiple fractures was higher than that in patients with proximal ulna fractures and radial head fractures; the OES score in patients with multiple fractures was higher than that in patients with proximal ulna fractures, and all differences were statistically significant ( P<0.05). Among 407 patients, complications included new-onset postoperative ulnar neuropathy in 61 cases, new heterotopic ossification in 11 cases, recurrent heterotopic ossification in 96 cases, elbow instability in 6 cases, and superficial surgical site infection in 2 cases. Conclusions:Open arthrolysis is an effective treatment option for post-traumatic elbow stiffness. Patients with preoperative heterotopic ossification have a greater postoperative flexion range and elbow flexion-extension range of motion. The surgical timing exerts no significant influence on the ultimate functional outcome of treatment in patients with post-traumatic elbow stiffness. Patients with different initial fracture sites exhibited significant differences in postoperative functional outcomes, including supination, DASH scores, and OES.