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.

OBJECTIVES: To investigate the associations between Tau protein deposition and brain biochemical metabolites detected by proton magnetic resonance spectroscopy (¹H-MRS) in patients with advanced Alzheimer's disease (AD). METHODS: From April, 2022 to December, 2024, 64 Tau-positive AD patients and 29 healthy individuals underwent ¹⁸F-APN-1607 PET/MR and simultaneously acquired multi-voxel ¹H-MRS in the Department of Nuclear Medicine, Nanjing First Hospital. Visual analysis and voxel-based analysis of PET/MR data were performed to investigate the Tau protein deposition patterns in AD patients. Valid voxels within the ¹H-MRS field of view were selected, and their standardized uptake value ratio (SUVr) in PET and metabolite levels of N-acetylaspartate (NAA), choline (Cho), creatine (Cr), NAA/Cr, and Cho/Cr were recorded. The Tau-positive (Tau⁺) voxels and Tau-negative (Tau^-) voxels of the AD patients were compared for PET and ¹H-MRS parameters, and the correlations between the metabolites and Tau PET SUVr within Tau⁺ voxels were analyzed. RESULTS: Significant Tau protein deposition were observed in the AD patients, involving mainly the bilateral frontal lobes (30.07%), parietal lobes (29.96%), temporal lobes (21.07%), and occipital lobes (15.89%). A total of 1422 valid voxels in AD group (including 994 Tau⁺ and 428 Tau^- voxels) and 814 voxels in the control group were selected. The AD patients showed significantly decreased NAA level and increased SUVr compared with the control group (P<0.05). Subgroup analyses revealed that Tau⁺ voxels had higher SUVr and lower Cr and Cho/Cr than Tau^- voxels (P<0.05). Compared with the control group, Tau⁺ voxels exhibited higher SUVr and lower Cr (P<0.05), while Tau^- voxels showed lower NAA (P=0.004). No significant differences were found in Cho or NAA/Cr among the subgroups (P>0.05). Within Tau⁺ voxels, NAA, Cho, and Cr were negatively correlated with SUVr (P<0.001). CONCLUSIONS The patients with progressive AD have significant Tau protein deposition in the brain, which is correlated with alterations in metabolite levels. Decreased NAA is more prominent in early or pre-tau deposition stages, while Cr changes is more significant in the regions with Tau protein deposition, suggesting the potential of NAA and Cr as biomarkers for Tau protein deposition in AD for disease monitoring and treatment evaluation.
Humans ; Alzheimer Disease/diagnostic imaging* ; Aspartic Acid/metabolism* ; tau Proteins/metabolism* ; Creatine/metabolism* ; Brain/metabolism* ; Biomarkers/metabolism* ; Positron-Emission Tomography ; Male ; Female ; Proton Magnetic Resonance Spectroscopy ; Choline/metabolism* ; Aged ; Middle Aged

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:Taking the main international collaborative innovation network management modes for clinical research as a reference, to promote the construction of a collaborative innovation network for clinical research in China.Methods:Using literature research, case study, comparative analysis, and interview methods, this study systematically studied the collaborative innovation network management modes of clinical research in the United States, the United Kingdom, Japan, South Korea, and China from the perspective of integrating and sharing clinical research resources.Results:Based on the comparative results and drawing on foreign experience, suggestions were proposed to optimize the management mode of the clinical research collaborative innovation network in China and promote the construction of clinical research collaborative innovation network.Conclusions:It is recommended to establish national medical research institutions, increase investment in clinical research funds, build a platform for integrating volunteer resources based on clinical research collaborative innovation networks, and establish a clinical sample resource service platform to further supplement and improve the structure and layout of China’s clinical research collaborative innovation network.

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:To investigate the mediating effect of social interaction on the relationship between internet use and the health status of the elderly.The findings of this research can potentially contribute new insights into improving the health status of the elderly population.Methods:Based on the data from the Chinese General Social Survey(CGSS)in 2021, a total of 2 675 elderly individuals aged 60 and above were included in the study.The researchers analyzed the linear regression relationship between Internet use, social interaction, and the health status of the elderly using a hierarchical regression model.Additionally, a mediation effect test was conducted using the Bootstrap test.Furthermore, heterogeneity analysis of the mediation effect was performed considering factors such as gender, place of residence, working conditions, and physical exercise among the elderly participants.Results:The total effect value was 0.170.The direct effect of Internet use on the health status of older adults was 0.160(95% CI: 0.078-0.240), accounting for 93.66% of the effect value.The indirect effect of social interaction was 0.011(95% CI: 0.003-0.021), accounting for 6.34% of the effect value.The mediating effect of social interaction on the health status of older adults varied among different groups.Among female elderly, rural elderly, elderly who are currently unemployed, and those who are physically active, the mediating effects were 5.16%, 7.86%, 10.18%, and 9.91%, respectively. Conclusions:The impact of internet use and social interaction on the health status of the elderly is notably positive.Additionally, social interaction partially mediates the relationship between internet use and the health status of the elderly.

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:To identify multimorbidity patterns in a nationally representative sample of elderly patients with chronic diseases and to explore the relationship between these multimorbidity patterns and health care utilization.Methods:Based on data from the China Health and Retirement Longitudinal Study(CHARLS)in 2018, 10 764 elderly people aged 60 years and older were included, and latent class analysis(LCA)was used to identify multimorbidity patterns in the elderly, and the Logistic model was used to analyze the relationship between multimorbidity patterns and healthcare utilization in 8 041 elderly people with complete information on the variables.Results:The primary LCA identified five categories, with 4 164(52.1%)participants belonging to the relatively healthy category.The other four categories represented different patterns of multimorbidity, with 473(5.7%)belonging to the respiratory disease category, 1994(25.3%)to the vascular disease category, 948(11.7%)to the stomach-arthritis/rheumatism disease category and 426(5.2%)to the multisystemic disease category.In terms of outpatient service utilization, compared with the relatively healthy category, the multisystemic disease category was the most likely one to seek outpatient services( aOR=2.920, 95% CI: 2.305-3.699), followed by the respiratory disease category( aOR=1.827, 95% CI: 1.429-2.336), the stomach-arthritis/rheumatism disease category( aOR=1.680, 95% CI: 1.392-2.027), and the vascular disease category( aOR=1.482, 95% CI: 1.267-1.734).In terms of inpatient service utilization, compared to the relatively healthy category, the multisystemic disease category was the most likely one to seek inpatient services( aOR=2.718, 95% CI: 2.158-3.425), followed by the respiratory disease category( aOR=2.627, 95% CI: 2.105-3.280), the stomach-arthritic/rheumatism disease category( aOR=1.940, 95% CI: 1.624-2.318), and the vascular disease group( aOR=1.887, 95% CI: 1.632-2.183). Conclusions:There is a significant correlation between multimorbidity patterns and outpatient and inpatient service utilization in the elderly.Compared to relatively healthy people, those with one of the other four multimorbidity patterns have a significantly increased risk needing outpatient and inpatient services.

Objective:To investigate scientific research integrity management in professional organizations and implementing units for medical projects in China, analyze the current status and issues of scientific research integrity management in major scientific and technological projects, and outline the requirements for research integrity management.Methods:A Combined quantitative and qualitative approach is adopted to describe the entire process of scientific research integrity management by responsible units in major medical science and technology projects and to understand the measures taken by professional management institutions in scientific research integrity management of major scientific and technological projects.Results:Responsible units have already implemented scientific research integrity management throughout the entire process of major projects, aiming to regulate the management of scientific research ethics and the declaration of human genetic resources. Although there was a lack of scientifically and effective scientific research integrity evaluation mechanisms within the government or professional institutions.Conclusions:Strengthening the construction of scientific integrity management systems within management professional institutions and responsible units, emphasizing comprehensive research integrity management throughout the entire research process, and establishing a multi-dimensional, all-encompassing research integrity oversight system for major projects are all conducive to enhancing the standardized management of medical research ethics and human genetic resources, This collaborative effort promotes the high-quality development of medical research.

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.