ObjectiveTo analyse the implementation of mutual recognition of ethical review in a tertiary hospital， providing ideas for exploring ethical review of multicenter studies. MethodsThe ethical review of multicenter studies conducted by the hospital from 2018 to 2022 was analyzed. ResultsA total of 1，582 projects were reviewed in the hospital from 2018 to 2022， of which 773 （48.9%） were multicentre studies. In multicenter study projects， 70.4% of the studies were conducted as a participating unit. Mutual recognition of ethical review and fast review were implemented for all participating projects. After a rapid review of 24 studies， the presiding committee recommended submitting them for conference review. The reasons for the transfer to conference review included issues with the study protocol （11 projects）， informed consent （12 projects）， and other supporting documents （5 projects）. Twenty-one studies were eventually approved by the ethics committee after modification， and 3 studies were not approved by the ethics committee because the sponsor refused to modify the study protocols. ConclusionFor participating in multicentre studies， the ethics committees of participating units implement mutual recognition of ethical reviews and adopt a rapid review approach to review all study data， which can achieve both quality and efficiency.

Objective:To compare the efficacy of minimally invasive steel plate combined with percutaneous hollow nail fixation through the sinus tarsi incision versus "L"-shaped incision steel plate fixation in the treatment of calcaneal fractures.Methods:A retrospective analysis was conducted on 103 cases of Sanders type II-IV calcaneal fractures treated with minimally invasive steel plate combined with percutaneous hollow nail fixation through sinus tarsi incision from January 2017 to March 2024 at the orthopedic department of Hangzhou Sir Run Run Shaw Hospital (minimally invasive group). An additional 103 cases treated with "L"-shaped incision steel plate fixation during the same period were included as controls (open group). The preoperative hospital stay, surgical time, postoperative hidden blood loss, postoperative hospital stay, postoperative infection rate, postoperative Bohler angle, Gissane angle, calcaneal mid-width, sustentacular effective fixation rate, and American Orthopaedic Foot and Ankle Society (AOFAS) ankle-hindfoot score at 6 and 12 months postoperatively were compared between the two groups.Results:There were no statistically significant differences in age, gender, diabetes, smoking history, and body mass index between the minimally invasive group and the open group ( P>0.05). In the minimally invasive group, the preoperative hospital stay (3.1±1.5 days), postoperative hospital stay (3.5±1.5 days), hidden blood loss (293.3±71.4 ml), surgical time (64.4±13.2 min), and AOFAS score at 6 months postoperatively (79.9±3.9) were superior to those in the open group (7.1±0.7 days, 5.6±0.9 days, 408.3±101.7 ml, 91.5±24.3 min, and 70.5±6.1, respectively) ( P<0.05), with no significant difference in AOFAS score at 1 year postoperatively ( P>0.05). Additionally, the preoperative hospital stay (3.7±1.5 days), postoperative hospital stay (4.0±2.0 days), hidden blood loss (336.3±75.3 ml), and AOFAS score at 6 months postoperatively (77.4±3.8) in the minimally invasive group were superior to those in the open group (7.6±0.9 days, 8.2±2.6 days, 441.3±89.2 ml, and 64.6±8.4, respectively) ( P<0.05), with no significant difference in surgical time and AOFAS score at 1 year postoperatively ( P>0.05). Within-group comparisons indicated that as fracture severity increased, preoperative ( P<0.05) and postoperative hospital stays ( P<0.05) increased in the open group, while surgical time increased in the minimally invasive group ( P<0.05). AOFAS scores at 6 months postoperatively varied between complex and simple fractures in both groups ( P<0.05). There were no statistically significant differences in postoperative Bohler angle, Gissane angle, and calcaneal mid-width between the two groups ( P>0.05). The sustentacular effective fixation rate in the minimally invasive group was 85.4%, superior to 47.4% in the open group for simple fractures ( P<0.05), with no statistically significant difference for complex fractures ( P>0.05). The incision infection rate was 0 in the minimally invasive group compared to 3 cases (3%) in the open group, with no statistically significant difference ( P=0.246). Conclusion:Minimally invasive steel plate combined with percutaneous hollow nail fixation through sinus tarsi incision for calcaneal fractures offers the advantages of shorter hospital stay, reduced surgical trauma, lower incision infection rate, and better short-term efficacy compared to open incision. It is suitable for most Sanders type II-IV calcaneal fractures.

Objective:Based on the serious situation of population aging and the need for geriatric healthcare guidelines in China, we constructed a framework on the need for national geriatric care guidelines and conducted relevant analysis, aiming to provide a reference for the formulation of guidelines for geriatric care.Methods:Literature review and expert consultations were used to construct a framework on the need for guidelines on geriatric care in China.Twenty-two experts were invited to form a consultation group, and two rounds of expert consultations and discussions were carried out using the Delphi method to update and adjust the framework.Hierarchical analysis was used to calculate the weight of each guideline direction.Results:A framework on the need for geriatric healthcare guidelines was developed, containing 7 first-level directions and 35 second-level directions, and the weights of the directions were derived, with the direction of guidelines on geriatric syndromes having the highest weight at 0.204, and the direction of guidelines on geriatric disease diagnosis and treatment having the second highest weight at 0.196.Conclusions:A preliminary framework on the need for geriatric healthcare guidelines has been established.It is fitting for the country's general conditions, takes into account the needs from multiple perspectives, has good coverage, and can be expected to solve a range of difficult and urgent issues in geriatric care and help promote the development of a set of high-quality guidelines in the field of geriatric healthcare.

Objective:Referring to the Code of Medical Research Integrity and Related Conduct, to investigate the current status of scientific research integrity management of tertiary medical institutions, and to understand the current status and possible problems of scientific research integrity construction in working mechanism, institutional specifications, education guidance, supervision and punishment of various institutions.Methods:An electronic questionnaire was distributed to 72 researchers covering 46 tertiary medical institutions. The research content included basic information about the institution, the construction of the management mechanism, and the current status of research integrity management.Results:All of the surveyed medical institutions established scientific research integrity systems, publicized the policy of scientific research integrity regularly, carried out self-inspection, and conveyed the cases of notifications and alerts.84.29% of units had ″related courses for academic norms/scientific research integrity″, training were set up in ″student enrollment″ for 82.86% of the units, in ″employee recruitment″ for 94.29% of the units, in "project application" for 84.29% of the units, etc. The incidence of research misconduct in medical institutions, in descending order, is improper authorship, duplicate application, split publication, failure to obtain ethical approval, and multiple submissions. The contributing factors came from the pressure of title promotion(72.86%), the lack of scientific research integrity knowledge (71.43%), and interest motivation(70%). The analysis showed that there was a correlation between the ″convenient and open channels for research misconduct complaints and reports″ and the occurrence of ″scientific research misconduct″.Conclusions:The tertiary medical institutions have well-established scientific research integrity management systems, have taken scientific research integrity as a regular management feature, and have used diversified publicity, education, and training methods to promote academic norms and knowledge of research integrity.

Objective:Analyze the ethical issues encountered or potential in the use of ChatGPT and explore its ethical norms and requirements.Methods:Based on the ethical perspective of medical scientific research, this paper analyzed the disputes existing in ChatGPT from the perspectives of morality, fairness, responsibility and supervision, and explored the reasons for the disputes from both subjective and objective aspects.Results:ChatGPT has ethical issues, fairness issues, accountability issues, and regulatory issues.Conclusions:Ethical issues in ChatGPT should be regulated from the perspectives of people-oriented, limiting monopoly, strengthening responsibility and insisting on development, to reduce potential risks and negative effects.

Objective:To build an investigator-initiated clinical research process management indicator system based on the theory of Hazard Analysis and Critical Control Point(HACCP).Methods:A plan was developed according to HACCP principles, and 23 experts were invited to form an expert advisory group. Literature research, panel discussion, and Delphi method were used to collect clinical research process management indicators, and the weight of each indicator was calculated via Analytic Hierarchy Process(AHP).Results:Two rounds of expert consultation were carried out with a high positive coefficient and a high expert authority level, and finally formed 3 primary indicators and 14 secondary indicators. The primary indicators were project establishment, project process management, and project implementation assessment, with weights of 0.142 8, 0.714 4, and 0.142 8, respectively.Conclusions:This study established a clinical research process management system based on HACCP theory from 3 dimensions: project establishment, project process management, and project implementation assessment, carried out precise management of clinical research according to the weights of secondary indicators, focusing on the content of indicators with great weight, and provided an important reference for the management of investigator-initiated clinical research.

Objective:To investigate the preparation methods and quality control of 177Lu-labeled radiopharmaceuticals, and conduct preliminary clinical application research. Methods:177Lu-1, 4, 7, 10-tetraazacyclododecane-1, 4, 7, 10-tetraacetic acid (DOTA)- D-Phe1-Tyr3-octreotide (TOC) and 177Lu-prostate specific membrane antigen (PSMA)-I&T were labeled by manual labeling and automatic labeling, respectively. Factors such as the amount of precursor and nuclide, reaction temperature, pH value, reaction time, labeling yield and specific activity were investigated. Quality control of the products were carried out, such as clarity, pH value, sterility, bacterial endotoxin and stability in vitro. 177Lu-PSMA-I&T was applied to the treatment of prostate cancer patients, and the efficacy was evaluated by SPECT/CT imaging. Paired t test was used to analyze the data. Results:The amount of precursor and nuclide, reaction temperature, pH value and reaction time of the two methods were basically the same, both with high yield and specific activity. The yield of 177Lu-DOTA-TOC automatic labeling was significantly higher than that of manual labeling (99.2±0.4)% vs (95.3±1.5)% ( t=7.17, P<0.001), and the specific activity were (91.6±13.7) vs (89.1±13.2) GBq/μmol. The yield of 177Lu-PSMA-I&T automatic labeling was also significantly higher than that of manual labeling (99.6±0.3)% vs (95.7±1.3)% ( t=8.24, P<0.001), and the specific activity were (96.1±14.3) vs (93.2±13.8) GBq/μmol. The labeled products were colorless clear solution with pH value of 6.5-7.0. The sterility and bacterial endotoxin met the requirements. The radiochemical purity of the labeled products was more than 95% after 48 h, which showed good stability. The clinical application of 177Lu-PSMA-I&T in patients with prostate cancer showed that both primary and metastatic lesions had good uptake. Conclusions:The labeling of 177Lu radiopharmaceuticals is simple and has high yield and stability. The application of automatic labeling can simplify the process, improve the yield and reduce irradiation.

Objective:To analyze the current situation of human genetic resources management in a tertiary hospital, and propose improvement suggestions for the management of human genetic resources in tertiary hospitals.Methods:According to the review of laws and regulations of human genetic resources management in China, analyze the current situation, challenges and management suggestions of human genetic resources management in this particular tertiary hospital, and further management suggestions are proposed.Results:Main problems were identified in the tertiary hospital, including the knowledge of researchers needs to be improved, and due to lack of supervision and management on process of human genetic resources projects, the management of investigator initiated clinical trials needs to be further strengthened.Conclusions:The tertiary hospital needs to strengthen the researcher training on the management of human genetic resources, establish the whole-process supervision of human genetic resources project and pay more attention to the management of investigator initiated clinical trials.

Objective:To evaluate the Scientific Research Efficiency in A Tertiary Hospital, and provide recommendations for further improvement based on evaluation results.Methods:We evaluated the scientific research efficiency of 35 disciplines in a Tertiary Hospital from 2015 to 2017 with Slack Based Measure based Data envelopment analysis(DEA).Results:The average efficiency value from 2015 to 2017 is 0.44-0.65.The efficiency of Scientific Research from high to low was: supportive department, surgery department, internal medicine.There are 13 disciplines (37.14%) which efficiency increases gradually and 7 discipline (20%) which efficiency decreases.9 disciplines are DEA valid (efficiency=1) for at least 2 years and 9 is DEA invalid (efficiency<1) in three years.The average slack variable of researchers is 18.6 while average slack variable of input scientific research fund is 23.38 million RMB.Conclusions:The average efficiency of the tertiary hospital shows a rising trend.However, the efficiency of disciplines varies largely.For DEA invalid disciplines, it is important to improve efficiency by increasing output and improving efficiency of scientific research funding.

Objective:To introduce the experience of international Investigator- initiated Clinical Trials (IIT), provide suggestions for the construction of IIT management system in China. Methods:Applying the literature review research methodologies to analyze the document materials, five aspects including the funding source, technical support, personnel training, management mechanism and policy assurance were analyzed.Comparison was conducted to identify possible problems existed in Chinese IIT, and further explore possible lessons that we can learn in Chinese context.Results:Identified problems of Chinese IIT include insufficient funds, unsound scientific research design, imperfect data information system, lack of standard training for researchers, as well as the urgent need for more optimized whole-process management, quality control, and policy support.Conclusions:Suggested series of measurements that including expand the funding sources, improve the construction of scientific steering committee, improve the construction of data information platform at the national level, standardize the training of researchers, and update the operation mechanism and also the regulatory requirement are proposed to enhance the IIT research quality, as well as the IIT management.