Comparison between China and the United States on clinical research methodology training for clinicians / 中华医学教育探索杂志

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.

Discussions on risk-based quality management of investigator initiated trials / 中华医院管理杂志

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.

Discussion on the construction standards of clinical research center initiated by researchers: A case study of clinical research institute of Shanghai Jiao Tong University School of Medicine / 中华医学科研管理杂志

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.

Awareness, demands and satisfaction of Traditional Chinese Medicine service among the elderly residents in nursing home / 中华全科医师杂志

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.

Factors affecting the outcome of surgical treatment for intertrochanteric fractures / 中华创伤杂志

Objective:To investigate the factors affecting the outcome of surgical treatment for femoral intertrochanteric fractures.Methods:A retrospective case series study was conducted for 424 patients with intertrochanteric fractures admitted to four hospitals in Shanghai from January 2014 to December 2016. There were 200 males and 224 females, aged 45-98 years [(77.8±10.5)years]. Normal union was observed in 326 patients (normal union group), and abnormal union was founded in 98 patients including nonunion in 2 patients (abnormal union group). Data were recorded including the age, gender, injury side, AO classification, Evans-Jesen classification, thickness of femoral lateral wall, medial support, tip-apex distance, and screw position within the femoral head. Fracture healing was assessed. Univariate analysis was conducted to examine differences of the above factors between two groups, and Logistic regression was used to screen the main factors affecting fracture union. At the latest follow-up, the hip joint function was estimated according to the Oxford score system.Results:All patients were followed up for 1-3 years [(2.2±0.3)years]. Univariate analysis showed significant differences between two groups regarding the AO classification, Evans-Jesen classification, medial support, tip-apex distance, and screw position within the femoral head ( P<0.05). Multivariate regression analysis revealed that the simple fracture ( OR=1.030), medial support ( OR=0.395), tip-apex distance ≤25 mm ( OR=0.266) and inferior screw position ( OR=0.986) were significantly related to fracture union. The hip function in normal union group was (42.6±4.5)points, better than (35.4±3.2)points in abnormal union group ( P<0.05). Conclusion:The stability of intertrochanteric fracture is the most important factor for fracture union. The medial support, tip-apex distance ≤25 mm and inferior screw position are helpful to promote fracture healing and recovery of hip joint function.

Clinical predictive value of short-term dynamic changes in platelet counts for prognosis of sepsis patients in intensive care unit: a retrospective cohort study in adults / 中华危重病急救医学

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.

Analysis and reflections on construction of clinical research methodology support system by IITs: Demonstration examples from construction of MACRO in Shanghai Jiao Tong University School of Medicine / 中华医学科研管理杂志

Objective To improve clinical research capability and quality,this study aims to explore the methodological support system of Investigator Initiated Trials (IITs).Methods By comparing the clinical research supporting system between commercial and academic organization at home and abroad,this study summarized their characteristics and make systematic analysis combined with IITs.Results Compared with international level,there is an urgent need to improve of domestic,professional support for clinical research.Academic clinical research supporting academic system could better satisfy the requirement of IITs in China.Taking Shanghai Jiao Tong University School of Medicine as an example,this paper introduces the a collaborative construction model,namely Multiple-center Academic Clinical Research Organization (MACRO),based on two levels of clinical research institutes in university and affiliated hospitals.At universities level,we focused on development of clinical research,top-level study design,clinical research methodology,clinical research professionals and standardized clinical research platform.At hospitals level,project process management can be emphasized,and which will be the main implementation content to build an applied clinical research technology center in MACRO.Conclusions With the construction of MACRO,the functional module paradigms of academic clinical research centers in university can be effectively linked to affiliated hospitals.This will be conducive for establishing collaborative support system,which is centered on academic research and complementary functions with multiple centers,improving full-time technical team and further enhancing the scientific validity and research quality of IITs.

Questionnaire analysis of clinical research capacity and training needs for physicians at university hospitals / 中华医学科研管理杂志

Objective Through investigating the clinicians’ scientific research level and weakness,we can carry out targeted clinical research training systematically,and then strengthen their utilization of clinical resources and data,and finally promote the transformation of scientific research resuits.Methods Filling and submitting the online questionnaires through WeChat,a popular chatting tool in China,physicians from 13 affiliated hospitals of a university in Shanghai have joined this research.Results 507 valid questionnaires have been received online:In terms of clinical research capacity,there seemed to be more barriers in the following issues:comprehension of the types and applications to design a clinical trial,formulation of the details including PICO elements(Patient-Intervention-Comparison-Outcome),methodological application including the category and principle of randomization,the category and principle of blind method and how to control the confounding elements and probable bias,and statistical problems in scientific research including discrimination of the different definition between FAS(Full Analysis Set) based on the principle of ITT(Intention-To-Treat) and PPS(Per-Protocol Set),how to write a standardized SAP(Statistical Analysis Plan) and how to calculate the sample size of a trial),and various management of clinical trials including data management,follow-up management,adverse event management and so on,and writing a protocol and a CRF (Case Report Form) in a standard and professional way.As for the needs for training,the top three topics were how to design a clinical research in a standardized style,how to practice the methodology and how to utilize the statistical skills into clinical trials.Conclusions Standardized design and writing of clinical trial protocols according to the CONSORT (Consolidated Standards of Reporting Trials) and SPIRIT (Standard Protocol Items:Recommendations for Interventional Trials),and the application of epidemiological and statistical methods are still short boards that most clinicians need to improve urgently,also are what they most concerned about at the same time.So it is necessary for physicians to receive systematic clinical research training to enhance their scientific research capacity.

Study on the correlation between different treatment methods and postoperative outcome in elderly patients / 重庆医学

Objective To analyze the correlation between the diagnosis and treatment and the postoperative death and complication of the elderly patients.Methods A total of 1 932 cases of surgical patients (over 70 years old) were collected from a three-level general hospital 2013-2015.Their medical information of the treatment methods were recorded,including incision category,surgical approach,surgical grade and patient outcome after surgery(death or postoperative complications).Then we analyzed the incidence of death or postoperative complications,as well as the effects of treatment and postoperative outcome on complications or mortality.Results The admission status and incision type were the risk factors of postoperative death in elderly patients.Admission status pollution type,surgical approach and surgical grade were the risk factors of postoperative complications.Conclusion In order to reduce the risk of postoperative death and complications in elderly patients,the effect of admission and incision on the postoperative risk of elderly patients should be evaluated.

Clinical efficacy of crossing cannulated screw fixation for treatment of intra-articluar calcaneal fractures / 中华创伤杂志

Objective To assess the clinical results of crossing cannulated screw fixation for intra-articulsr calcaneal fractures.Methods A total of 65 patients (72 sides) were retrospectively studied from July 2012 to June 2015 by case-control study,including 63 males and two females at age range of 18-70 years [(45.7 ± 12.2) years].According to the Sanders classification,there were 49 fractures of type Ⅱ (25 type Ⅱa,17 type Ⅱb,7 type Ⅱc) and 23 fractures of type Ⅲ (12 type Ⅲab,6 type Ⅲac,5 type Ⅲ bc).The cases had been divided into two groups,namely,the crossing caunulated screw fixation group (CCSFG group,30 cases) and plate fixation group (PFG group,42 cases).The results were compared with regard of the hospitalization time,fracture reduction and union,AOFAS score system,and complications.The calcaneal shape was assessed by the length,width,height,Bhler angle and Gissane angle.The foot function was assessed by the American Orthopedic Foot and Ankle Society (AOFAS) ankle-hind foot score system.Results All were followed up for 6-24 months [(15.2 ± 4.7)months],and presented fracture healing.The time of hospitalization was (10.2 ± 2.3)days (7-14 days) and (18.6 ±3.3)days (13-28 days) in CCSFG and PFG groups,respectively(P ＜0.05).At the first and final visits during follow-up,the changes in calcaneal width and B(o)hler angle of CCSFG group were smaller than that of PFG group (P ＜ 0.05).For Sanders Ⅱ type cases,the average AOFAS function scores in CCSFG and PFG groups were (89.3 ± 6.8) points and (90.1 ± 8.1) points,respectively (P ＞ 0.05).For Sanders type Ⅲ cases,the corresponding scores in CCSFG and PFG groups were (83.5 ± 10.8) points and (82.5 ±7.3)points,respectively (P ＞0.05).The complication rate in the CSFG and PFG groups was 20％ and 19％,respectively (P ＞ 0.05).Conclusions Compared with the plate fixation,the crossing cannulated screw fixation has advantages of less invasion,better stability,shorter hospitalization time,faster functional recovery and can be recommended as the first choice for mild to moderate comminuted calcaneal fractures.

Relationship between environmental tobacco smoke and lung cancer risk among nonsmokers in China: A meta-analysis / 中华预防医学杂志

<p><b>OBJECTIVE</b>To investigate the relationship between the environmental tobacco smoke (ETS) and lung cancer by Meta-analysis.</p><p><b>METHODS</b>We used "lung cancer/lung neoplasm", "non-smoking/non-smoker", "China/Chinese", "case-control/case control", "risk factor", "environmental tobacco smoke/passive smoking" as key words, to search papers in databases including Chinese BioMedical Literature (CBM), China National Knowledge Internet (CNKI), Wanfang, Vip Citation Databases (VIP), PubMed and Web of Science databases, and collected the case-control studies on ETS and lung cancer among Chinese non-smokers from January 1999 to December 2013. A total of 129 research papers were collected. RevMan 5.2 software was used to calculate combined odds radio (OR) and 95% CI.</p><p><b>RESULTS</b>Qualified 18 literatures were included, total cases 6 145 and controls 8 132. Consolidated results showed that ETS exposure could increase the risk of lung cancer, combined OR (95% CI) = 1.52 (1.42-1.64). Stratified analysis showed that ETS exposure was found to be significantly associated with an increasing risk of the lung cancer on non-smoking women and men, and combined OR (95% CI) were 1.58 (1.42-1.75) and 1.34 (1.08-1.65), respectively; the ETS exposure from family or the working environment could increase the risk of lung cancer, and combined OR (95% CI) were 1.48 (1.20-1.82) and 1.38 (1.13-1.69) respectively; childhood exposure and adult exposure were no significant statistical significance, and combined OR (95% CI) were 1.37 (0.98-1.91), and 1.34 (0.97-1.85) respectively.</p><p><b>CONCLUSION</b>Environmental tobacco smoke exposure was a significant risk factor of lung cancer among non-smokers in China.</p>