1.Practice and reflection on ethical review of multicentre studies in a tertiary hospital
Lingling YU ; Wei LIU ; Pengjun ZHANG
Chinese Medical Ethics 2025;38(1):58-62
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.
2.Effectiveness analysis of minimally invasive sinus tarsi incision with steel plate combined with percutaneous hollow nail in the treatment of calcaneal fractures
Jia CHEN ; Pengjun YU ; Jian ZHANG ; Yilei CHEN
Chinese Journal of Orthopaedics 2024;44(12):825-832
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.
3.The Influence of Internet Use on the Health status of the Elderly: a Mediating Effect Analysis Based on Social Interaction
Mengyao REN ; Ruijia TAO ; Qiang GAO ; Miao XU ; Pengjun ZHANG ; Chen WANG
Chinese Journal of Geriatrics 2024;43(5):609-615
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.
4.The development of a framework on the need for elderly healthcare guidelines in China and related issues
Bi ZHANG ; Lingling YU ; Qiang GAO ; Pengjun ZHANG
Chinese Journal of Geriatrics 2024;43(9):1131-1136
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.
5.Current situation of research integrity management in tertiary hospitals
Miao MIAO ; Lingling YU ; Qiang GAO ; Pengjun ZHANG
Chinese Journal of Medical Science Research Management 2024;37(3):181-186
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.
6.Research on collaborative innovation network management modes of clinical research abroad and its enlightenment for China
Mei ZHANG ; Qiang GAO ; Mengyao REN ; Miao XU ; Xiangyu LUO ; Pengjun ZHANG
Chinese Journal of Medical Science Research Management 2024;37(3):235-240
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.
7.ChatGPT and medical research ethics: Debates and norms
Qiang GAO ; Mengyao REN ; Miao XU ; Lingling YU ; Bi ZHANG ; Pengjun ZHANG
Chinese Journal of Medical Science Research Management 2023;36(3):161-166
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.
8.Investigation on the demand and management status quo of scientific research assistants in hospitals and analysis of their development path based on the perspective of scientific research managers
Boya PENG ; Pengjun ZHANG ; Miao MIAO ; Qiang GAO ; Yuqing WANG ; Chen WANG
Chinese Journal of Medical Science Research Management 2023;36(3):220-224
Objective:This study aims to explore the possible development path of hospital research assistants in China based on the cognition of the demand and management status quo from research management personnel in tertiary hospitals.Methods:62 scientific research management personnel from all over the country were surveyed, data about their cognition and the current status of scientific research assistants, that including the willingness of employ, position cognition, eligibility and competence, quantity and efficiency, management implementation, influencing factors and difficulties in team development, were collected and analyzed. Regarding to the practical needs and management status, the results were described by frequency, percentage and average score, and the rank sum test was used to verify whether there was any difference in the employment intention between the management department and the project team in the cognition of the survey subjects.Results:From the perspective of scientific research managers, there is a strong willingness at hospital level to employ the research assistant, positions require applicants with bachelor′s degree or above in medicine or other related majors. The most urgent needs are management of project funds, equipment and consumables, research integrity and ethics.The interviewees who work with research assistants think that the effect of research assistants on improving scientific research efficiency is obvious.However, the percentage of formulation of research assistants management measures is less than 40%, and the percentages of uniformly organized training and assessment are relatively low. There are still problems and challenges, such as incomplete cognition of the positioning and function, incomplete functional and vocational system, imperfect incentive mechanism and insufficient support for ability cultivation and improvement.Conclusions:It′s necessary to strengthen the top-down design of the development of scientific research assistant team and the construction of career system, improve the management basis and implementation mechanism, supporting resources should be in place, and promote capacity building system in order to develop a long-term mechanism of mutual promotion between the team building of scientific research assistants and the innovation of hospital scientific research management.
9.Based on the status of scientific research integrity management of major projects in the medical field
Miao MIAO ; Bi ZHANG ; Boya PENG ; Qiang GAO ; Pengjun ZHANG
Chinese Journal of Medical Science Research Management 2023;36(5):342-346
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.
10.Multimorbidity patterns in the elderly and their association with health care utilization
Mengyao REN ; Qiang GAO ; Pengjun ZHANG
Chinese Journal of Geriatrics 2023;42(9):1110-1116
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.

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