Objective To apply MINI-VIDAS automated multiparametric analyzer to auxiliary diagnosis of the serviceman in order to evaluate its clinical value.Methods Totally 1 528 servicemen complaining of acute chest pain were divided into group A and group B equally; the ones in group A went through conventional examination, and the ones in group B underwent conventional examination combined with instant examination with MINI-VIDAS automated multiparametric analyzer. The differences between the two groups were compared for the interval from hospitalization to definite diagnosis, diagnosis correctness, hospitalization rate, length of stay, recovery rate, improvement rate and etc, and then statistical analysis was carried out.Results The two groups had significant differences in the interval from hospitalization to definite diagnosis and diagnosis correctness (P<0.05), while no statistical differences in hospitalization time, recovery rate and improvement rate (P>0.05).Conclusion MINI-VIDAS automated multiparametric analyzer can be used for the instant examination of cardiac marker to improve the diagnosis of the acute chest pain, and thus can be popularized in military hospital.

Objective:To explore the critical issues in the construction of management and supporting system of Investigator-Initiated trials (IIT) in pediatrics.Methods:Through summarizing related literature and considering the current status of pediatric clinical research, the critical issues in the construction of management and support system, for instance, the responsibility, training model, and performance evaluation in Europe and U. S. were evaluated, decision-making suggestions were put forward based on domestic pediatric IIT management system.Results:Besides IIT, clinical trials on children′s drugs are also supported by the pediatric clinical research management system in Europe and U. S.. The supporting service covers research consultation, ethical review, research design, trial implementation, patient education, risk control, and investigator training. The organizational structure and management system are relatively mature. Clinical trials are the majority of clinical research in children′s hospitals in China. Main issues identified in the construction of the management and supporting system include ethical review for pediatric clinical research, professional investigator training, multicenter cooperation scheme, performance assessment, and incentive strategies.Conclusions:Taking account into the current status of pediatric IIT in China, it is urgent to accelerate the training of pediatric investigators, set up standard IIT project management team, build the professional project management platform and Electronic Data Capture System, and promote the transformation of research outcomes. Finally, the whole process management of pediatric IIT will be developed to facilitate the development of pediatric medicine.

Objective:To standardize the management of pediatric Investigator-Initiated Trails (IIT) and improve the execution quality, this study takes a tertiary hospital for children in Shanghai as an example to analyze and summarize the main quality problems in the implementation of pediatric IIT projects and provide appropriate suggestions.Methods:From 2020 to 2022, based on the quality indicators of the IIT project of Shanghai Jiao Tong University School of Medicine, and combined with the characteristics of pediatrics, a centralized monitoring method was used to conduct spot checks and evaluations on the IIT project of a tertiary hospital for children in Shanghai.Results:From 2020 to 2022, a total of 77 IIT projects were inspected, including 27 in the initiation stage, 36 in the execution stage, and 14 in the conclusion stage. In terms of ethical compliance, there are issues with researchers′ weak ethical awareness and non-standard signing of informed consent in the pediatric IIT project. The main problems in terms of execution quality and science include non-standard CRF table design, insufficient awareness of safety management, lack of emphasis on research registration and specialized data management, randomization and blind methods. There are issues with low enrollment rate and low funding execution rate in terms of execution progress.Conclusions:There are certain quality problems during the execution of pediatric IIT projects. Strengthen the establishment of an effective process management and supervision system to improve the quality management of pediatric IIT research processes is needed.