Objective·To analyze the development trend and current situation of high-level clinical research at Shanghai Jiao Tong University School of Medicine(SJTUSM)from 2015 to 2023,and to summarize the strategies for improving clinical research capability of SJTUSM,aiming to provide reference and inspiration for medical universities to promote high-level clinical research.Methods·Papers published by first authors from SJTUSM or its affiliated hospitals during this period were retrieved in the Web of Science core collection database.General descriptive methods were used to quantify the number of clinical research papers,registered clinical trials,clinical research talent teams,and the current status of clinical research cooperation.Bibliometric methods were used to visualize the international collaboration and topic distribution of retrieved clinical research papers.The differences in the number of clinical research publications,Q1 publications,publications in top clinical medical journals,and full-time researchers between the periods of 2015?2018 and 2019?2023 were compared and analyzed.Results·From 2015 to 2023,a total of 9 468 clinical research papers were published by SJTUSM or its affiliated hospitals as the first author's institution,showing an increasing trend year by year.During this period,the number of Q1 publications of SJTUSM's clinical research,publications in top clinical medical journals,clinical studies registered on the United States Clinical Trial Registry website,clinical studies registered on the Chinese Clinical Trial Registry website,clinical guidelines and expert consensus publications,full-time research team members,and newly added national-level talents all showed an overall upward trend.Tumors,cardiovascular and cerebrovascular diseases,major chronic diseases,and mental illnesses were the main research hotspots.A total of 1 308 papers(13.82%)were international collaborative papers.Developed countries/regions such as the United States(733 papers),Australia(137 papers),and the United Kingdom(99 papers)were closely cooperating with SJTUSM.From 2019 to 2023,there was a significant increase in the number of clinical research papers,Q1 publications,publications in top clinical medical journals,and newly added full-time research team members in affiliated hospitals compared to the period from 2015 to 2018(all P<0.05).Conclusion·SJTUSM has strengthened top-level design,conducted in-depth major diseases,and constructed a systematic,integrated and closed-loop model for enhancing clinical research level along the"platform-talent-methodology"pathway,resulting in a number of high-quality clinical research outcomes.

Purpose/Significance To solve the problem that regional clinical research data are difficult to integrate efficiently,and to promote"Chinese evidence"and"Chinese protocol"in the global clinical research community.Method/Process Based on the standard-ization theory,the data standardization system is proposed,and the construction and application methods of the regional clinical research data platform are explored with the integration of multi-center clinical research data as the starting point.Result/Conclusion The theo-retical framework of the regional clinical research data platform has been preliminarily established,and the clinical research capabilities of tertiary hospitals in Shanghai have been significantly improved.

China/epidemiology* ; Humans ; Pemphigoid, Bullous/epidemiology* ; Retrospective Studies

By comparing the training status of clinical research methods between United States and China, this article introduces comprehensive training system in the United States in and after the university, and discusses the problems in clinical research methodology training in China. These issues include that when medical students at school do not receive the training of professional clinical research courses, and after they go to the work, they also lack professional and accurate clinical research methodology training, which make it difficult for doctors to independently conduct clinical research. Therefore, it is recommended that Chinese medical schools should systematically establish clinical research methodology courses for undergraduates and graduate students to cultivate the clinical research capabilities of medical students. Secondly, according to the clinical research levels of doctors, different training models are proposed in the study. The existing social resources should be scientifically guided. We hope our work would provide some references for the improvement of clinical research methodology in China, to promote clinicians to be independently responsible for conducting clinical research, and improve the national medical level.

Effective supervision of the clinical research management department can guarantee and improve the quality of the investigator initiated trials(IIT). The authors analyzed relevant clinical research regulations and literature and summarized the current situation of risk-based IIT project process quality management. On such basis, they determined the risk-based IIT project process quality management method in combination with the previous research of the research group.From 2021 to 2022, this method was used to implement process quality management for 353 IIT projects in Shanghai′s tertiary hospitals. More than 3 000 risk points were identified through centralized supervision, and then on-site supervision was carried out to correct the problems found. As proven by the results, the method could find existing problems in time and define the risk level of the project, and also formulate an individualized risk supervision plan accordingly, so as to effectively ensure the data reliability and scientific results. It is suggested that the clinical research management department implement risk based management for the whole process of IIT projects, increase funding and staffing, and implement hierarchical management for the projects by research types, so as to promote the sustainable development of IITs.

Objective:Investigator Initiated Trials (IIT) play a key role in promoting comprehensively the development and homogeneity of clinical diagnosis and treatment, thus, this article aims to explore a set of recommendations for the construction and management of clinical research institutes that support IIT.Methods:Through the combination of literature review and institutional construction practice cases, based on the experience of domestic and foreign universities and well-functioning medical institutions in building clinical research centers, as well as summarizing the construction cases of the clinical research institute of Shanghai Jiao Tong University School of Medicine, to discuss the construction and management plan of such centers.Results:Propose recommendations for the construction and management standards of clinical research centers that support IIT, covering the principles of center construction, basic settings, organizational structure, functional departments, basic platforms, staffing, document management and institutional evaluation.Conclusions:We hope this study can provide reference to universities and medical institutions for the construction of the clinical research institute.

Objective:To survey the status quo of awareness, demands and satisfaction of Traditional Chinese Medicine (TCM) service among the elderly residents in nursing home.Methods:A randomized survey on the status quo of TCM service was conducted from May to July 2019 among 237 elderly in 9 long-term care facilities close to a TCM hospital in Pudong New Area. The awareness, demands, satisfaction and influencing factors were analyzed.Results:Among 237 participants, only 1(0.4%)knew the TCM and its care well, however, 195 (82.3%) showed demands of TCM service. There were significant differences in the scores of demands and satisfaction of TCM among participants with different age, education level, marital status, medical insurance and health level ( P<0.05). Among the 16 TCM services, the three with top demand scores were acupoint massage (3.54±1.21), TCM health education (3.29±1.08), TCM drug iontophoresis (3.23±1.26); the three with top satisfaction scores were TCM health education (3.38±0.94), traditional health exercise (3.33±0.95), moxibustion (3.32±1.15). The demands and satisfactory were most correlated with each other in the guidance TCM medication ( r=0.996) and TCM herb tea ( r=0.988); and least correlated in the identification of TCM constitution ( r=0.305) and acupoint massage ( r=0.484). Conclusions:Among the elderly in long-term care facilities the awareness of TCM is at a low level, while the demands of TCM service are high. It is necessary to promote TCM service for elderly in long-term care facilities through TCM health education and developing the TCM products and appropriate techniques.

Objective:To investigate the efficacy of using a pediatric-inspired regimen for adolescents and young adults (AYA) with Philadelphia chromosome-negative (Ph -) acute lymphoblastic leukemia/lymphoblastic lymphoma (ALL/LBL) at a single center in China. Methods:Clinical data of 71 consecutive newly diagnosed AYA patients with Ph - ALL/LBL on a pediatric-inspired regimen in Peking Union Medical College Hospital from January 2012 to November 2018 were retrospectively analyzed. Results:Median age at diagnosis was 20 years (range: 15-38) , and 46 patients (64.8%) were male. Forty-nine (69.0%) had B-ALL/LBL. Among 62 ALL patients, 22 (35.5%) were high-risk. Complete remission rate was 93.0%. At follow-up with a median time of 44 months, the estimated 5-year disease-free survival (DFS) and overall survival (OS) was 56.3% and 64.3%, respectively. There was no significant difference in 5-year OS between allogeneic hematopoietic stem cell transplantation group and the continuous chemotherapy group after completion of 4 courses of chemotherapy. The 5-year DFS and OS for the non-high-risk group was 63.1% and 73.7%, respectively, which were significantly higher than 32.0% and 44.4% for the high-risk group, respectively ( P<0.001) . Conclusions:The use of pediatric-inspired regimen for AYAs with Ph - ALL/LBL was feasible and effective.

Objective:To study the orthopedic treatment strategy for hemophilia complicated with musculoskeletal disorders as well as the peri-operative consumption of clotting factor.Methods:Total 338 orthopedic surgeries were performed for 261 patients, average age of 30.6 y (6-65 y) , with hemophilia between January 1996 and December 2019 at our institute. Two hundred and twenty-six patients presented with bleeds within the joints. Sixty-one patients presented with intramuscular bleeds, 45 presented with hemophilic pseudotumors, and six presented with miscellaneous complaints. Strategy of clotting factor replacement therapy was designed as per differences in the level of the operation procedure. Information regarding clinical manifestation, operative strategy, clotting factor consumption, and re-operation for complications was retrospectively recorded. The costs for multiple joint procedure and single joint procedure were studied.Results:We found that 270 of the 338 surgical procedures were major surgical procedures (79.9%) . There were 203 procedures of joint arthroplasty (60%) . Fourteen patients underwent reoperations for local recurrence (4.2%) . The average factor Ⅷ consumption before the surgery was 44.4 ± 8.1 IU/kg. The average FⅧ consumption within postoperative 2 weeks was 40 962 IU (647±177 IU/kg) . Seven type A hemophilic patients developed F Ⅷ inhibitor following the surgical procedure, with an average level of 13.7±11.2 BU/mL. Sixty-eight patients underwent multiple joint procedures under one anesthesia session (26%) . There was no significant difference in the factor consumption between the multiple joint procedure and single joint procedure.Conclusions:Surgical treatment was found to be effective for hemophilic arthropathy and lesion of the musculoskeletal apparatus, with the clotting factor replacement therapy. Multiple joint procedures under one anesthesia were more cost effective for patients with hemophilia, with less factor consumption than staged single joint procedure.

Objective:To explore clinical predictive value of short-term dynamic changes in platelet counts (PLT) for prognosis of sepsis patients in intensive care unit (ICU).Methods:A retrospective cohort study was conducted. The patients aging 18 to 80 years old who were diagnosed by Sepsis-3 admitted to ICU of South Branch of Shanghai General Hospital from November 2015 to October 2018 were enrolled. According to whether the patients died within 28 days, they were divided into death and survival groups. General information and clinical baseline data [including disease severity score, infection biomarkers, PLT and organ function parameters (cardiac, liver, kidney, coagulation) and inflammatory cytokines] between the two groups were compared. Based on clinical indicators which had statistically significance, receiver operating characteristic (ROC) curve was drawn to predict the prognosis of the patients within 28 days. Then, risk factors of 28-day mortality of sepsis patients in ICU were screened by univariate and multivariate Logistic regression analysis. On the basis of multivariate Logistic regression analysis results, a multiparameter model was built, and the ROC curve was drawn to predict its prognosis within 28 days.Results:A total of 220 sepsis patients were enrolled. Among them, 61 patients died and 159 patients survived within 28 days with a 28-day mortality of 27.7%. Compared with the survival group, the patients in the death group were senior in age, more likely to suffer from chronic cardiovascular, chronic kidney and immune system disease, had higher scores in acute physiologic and chronic health evaluation Ⅱ (APACHEⅡ) score, sequential organ failure assessment (SOFA) score, disseminated intravascular coagulation (DIC) score and less PLT on the 1st and 7th day, sustained a higher incidence of persistent thrombocytopenia (PLT were all < 100×10 9/L in the first week after ICU admission) or acquired thrombocytopenia (PLT ≥ 100×10 9/L on the day of ICU admission, but dropped over 50% during the first week after ICU admission), were subjected to higher procalcitonin (PCT) and interleukin-6 (IL-6) levels and endured worse organ function (cardiac, kidney, coagulation) with statistically significant differences. However, there was no significant difference in gender, disease type, infection sites, pathogens or liver function. The ROC curve analysis for the 28-day prognosis of sepsis illustrated that the three disease severity scores could predict the 28-day prognosis of sepsis in ICU, and the area under ROC curve (AUC) of SOFA score was the highest (AUC = 0.878). The AUC of PLT on the 7th day was higher than that on the 1st day (AUC: 0.862 vs. 0.674), and the AUC of other clinical indicators were all < 0.8. Univariate and multivariate Logistic regression analysis showed that SOFA score [odds ratio ( OR) = 1.423, 95% confidence interval (95% CI) was 1.089-1.859, P = 0.010], troponin I (TnI; OR = 2.056, 95% CI was 1.057-3.999, P = 0.034), and persistent or acquired thrombocytopenia ( OR = 13.028, 95% CI was 4.033-42.090, P < 0.001) were three independent risk factors for 28-day mortality of the sepsis patients in ICU. Based on the multivariate Logistic regression analysis results, a multiparameter model was built with SOFA score, TnI and persistent or acquired thrombocytopenia, which showed a AUC of 0.926 to predict the 28-day mortality of sepsis patients in ICU. When the optimum cut-off value was 0.398 in the model, the sensitivity was 76.8%, and the specificity was 92.8%. Conclusions:Persistent or acquired thrombocytopenia within the first week of hospitalization proves to have a relatively momentous clinical predictive value for prognosis of sepsis patients in ICU. Clinical intervention focusing on thrombocytopenia may become a new potential therapy for these sepsis patients.