ObjectiveTo investigate the domestic and abroad hypertension-related clinical trial registration and to analyze the registration of hypertension-related clinical researches in China.MethodsUsing hypertension as the keyword, we searched ClinicalTrials.gov and Chinese Clinical Trial Registry (ChiCTR) from January 2008 to December 2018. We analyzed the collected data on the distribution of registered clinical researches, annual trends, sample sizes, trial progress, research types, study designs, blind methods, clinical stages, the number of participating institutions, the leading institutions, etc.ResultsThe total number of registered hypertension-related clinical trails was 4 991 all over the world, and 551 items were conducted in China. Most of the sample sizes of Chinese hypertension-related clinical trials were 100 to 999. The main types of trials were interventional studies (393 items, 71.32%), followed by observational studies (126 items, 22.87%). Randomized parallel control studies (300 items, 76.34%) were the key component of interventional studies, while cohort studies (61 items, 48.41%) were the chief component of observational studies. The main stages of clinical trials were stage Ⅲ (80 items) and stage Ⅳ (122 items). There were 369 domestic single-center clinical trials (66.97%), 89 domestic multi-center clinical trials (16.15%), and 93 international multi-center clinical trials (16.88%). Among the 93 international multi-center trials of hypertension, only 25 were led by China.ConclusionsThe number of Chinese hypertension-related clinical trial registrations increased year by year and then decreased slightly, but the amount of registrations is limited. The quantity and scale of multicenter clinical studies were not as good as America. China should strengthen the awareness of clinical research registration, strengthen the publicity and supervision of the registration of clinical researches by the department of science and management, improve the number of clinical trial registrations, make Chinese clinical researches more transparent, and strive to lead more international multi-center clinical trials.
Objective To evaluate the short-term effectiveness and safety of laparoscopic versus conventional open left hepatectomy. Methods Databases including CENTRAL (Issue 1, 2012), MEDLINE/PubMed (1978 to 2012), EMbase (1966 to 2012), CBM (1978 to 2012), CNKI (1979 to 2012) and the Chinese Medical Association Figures Journal Systems (1990 to 2012) were searched to collect clinical trials on laparoscopic versus conventional open left hepatectomy. Relevant proceedings and references of the included studies were also retrieved manually. According to the inclusion criteria, two reviewers independently screened literature, extracted data and assessed quality. Then meta-analysis was conducted using RevMan5.0 software. Results No randomized controlled trials were collected, and a total of 5 clinical concurrent controlled trials involving 319 patients were included finally. The results of meta-analysis showed that, compared with the conventional open group, the laparoscopic group was longer in the operation time (WMD=40.89, 95%CI 29.39 to 55.38, Plt;0.000 01), and was lower in the intraoperative blood loss (WMD=−107.84, 95%CI −208.96 to −6.73, Plt;0.04); but there was no significant difference between the two groups in terms of hospital stays (WMD=−3.78, 95%CI −9.60 to 2.04, P=0.20) or postoperative complications (WMD=0.69, 95%CI 0.37 to 1.29, P=0.25). Conclusion As a minimally invasive technique, laparoscopic left hepatectomy has advantages of small abdominal incision and less intraoperative blood loss, and it is helpful to improve the quality of life for patients. Due to the limitation of quantity and quality of the included studies, it is hard to estimate the impact of bias on the reliability of this conclusion. We advise to perform more high quality, large scale and multicenter studies with adequate follow-up in the future.
Objective To compare the survey results of the 8-year program students of clinical medicine discipline before and after the implementation of system-based integrated course reform, to provide feedback for system-based integrated course reform. Methods The questionnaire survey was continuously conducted for 2 years among the 8-year program students in grade of 2005 and 2006, so as to investigate their attitudes towards the integrated clinical courses, then relevant improvement of teaching measures were performed according to their feedback, and the difference of teaching effects between those 2 years was finally compared. Results A total of 79 students in grade 2005 and 78 students in grade 2006 were investigated. The baseline data were matched between the 2 grades. The results of statistical analysis showed that, the overall cognition (χ2=32.924, Plt;0.000 1) and assessment (t=−2.900, P=0.004) of integrated courses among students in grade 2006 got more improved in comparison with the students in grade 2005, and more students tended to select integrated courses, but there was no statistical difference. Conclusion Although system-based integrated clinical course as a new thing has its limitations, the reform idea and direction are still approved by students, so it is worth popularizing.
Objective To collect the clinical data of victims with traumatic brain injury (TBI) admitted in the West China Hospital of Sichuan University within 2 weeks after 4.20 Lushan earthquake, and to analyze their clinical characteristics and effects of early rehabilitation, so as to provide baseline data for rescue TBI victims with the early rehabilitation treatment during emergency medical rescue. Methods A total of 392 victims admitted in the hospital from April 20th, 2013 to May 3rd, 2013 were screened, of which the TBI victims were clinically assessed and treated with early rehabilitation. Then both the activities of daily living (ADL) and the Rancho Los Amigos Cognitive Recovery Scale (RLA) before and after the treatment were analyzed. The data were input by Excel software, and the statistical analysis was performed by SPSS softwar. Results A total of 51 TBI victims at age from 3 to 84 years old were included finally. The categories of TBI included subarachnoid hemorrhage (41.2%), intracranial hematoma (33.3%) and mixed type (33.3%), and the severity were associated with the type of TBI. The GCS score of cerebral concussion was higher (13.25 ± 0.62) while that of the diffuse axonal injury was lower (4.50 ± 0.71). All victims (100%) had limited ADL, 74.51% had cognitive dysfunction, 9.80% had speech disorder, and 7.84% had dysphagia. After the early rehabilitation treatment, both ADL (before treatment: 34.82 ± 58.29, after treatment: 69.63 ± 22.29) and RLA (pre-treatment: 4.16 ± 1.24, treatment: 7.20 ± 1.69) were obviously higher than those before treatment, with statistical differences (both P lt;0.05). Conclusion The TBI categories of Lushan earthquake victims are various and mixed, and the severity associated with the type of TBI. All TBI victims are accompanied with more clinical problems and functional limitation. Early rehabilitation treatment is safe and effective to improve ADL and RLA as well.
Objective To evaluate the quality of Chinese clinical practice guidelines published in domestic medical journals in 2011. Methods The following 4 Chinese databases including WanFang Data, VIP, CNKI and CBM were searched from January 2011 to December 2011. The quality of included guidelines was assessed by using AGREE II. Results A total of 75 guidelines published in 2011 were included. Among them, 10 guidelines (13%) stated the conflict of interest, 10 guidelines (13%) mentioned evidence-based developing, 5 guidelines (7%) performed evidence grading system, 8 guidelines (11%) performed recommendation strength grading system, and 4 guidelines (5%) performed both evidence and recommendation strength grading systems. The ratio of the 6 domains’ scores of AGREEⅡ were as follows: scope and purpose (18%), stakeholder involvement (11%), rigour of development (8%), clarity of presentation (34%), applicability (5%), and editorial independence (14%). Conclusion Compared with the guidelines published before, the guidelines of 2011 have a higher quality and some of them are progressively standardized in developing methodology.
Objective To introduce how to use Stata software to implement the randomization of clinical trials. Methods Some examples were taken to describe how to implement the randomization of each kind of clinical trials. Results Stata implemented its required functions, such as simple randomization, stratified randomization, block randomization and the randomization of group treatment. Conclusion Stata can easily implement the randomization of clinical trials.
Objective To evaluate the effect and significance of PBL in clinical skills experiment teaching center (CSETC). Methods A total of 60 undergraduates in major of clinical medicine were divided into two groups according to their student ID. The control group (n=30) was set in an ordinary small classroom, while the experimental group (n=30) was in CSETC for fully using the teaching resources there. Both groups were taught with PBL method by same teachers, and the integrated final examination and questionnaire were adopted to evaluate the teaching effect. SPSS was used for statistical analysis. Results All 8 participated teachers believed that carrying out PBL in CSETC could promote teachers’ professional development, alleviate the shortage of teachers and classroom, increase the utilization ratio of CSETC, and improve the teaching quality. The results of survey on students showed that, compared with the control group, information management ability and clinical skills of students were improved obviously (Plt;0.01). Although there was no difference in total score of final exam, the experimental group was markedly higher than the control group in the score of clinical skill subject (Plt;0.01). Conclusion Carrying out PBL in CSETC can improve teaching quality, and clinical skills and information management ability of students. It is helpful to alleviate the shortage of teachers and classroom, and promote the teaching standards of CSETC.
Clinical endpoint committee (CEC) plays an important role in the process of the endpoint events adjudication in clinical trials. It greatly influences quality control of clinical trials, the importance of which increases especially after the emergency of the definition of clinical endpoint events by Academic Research Consortium (ARC). In this paper, we briefly introduce the role of CEC in the process of the quality control of clinical trials, application of CEC in China and abroad, and its influence to the primary endpoints. We also investigate the application and development of CEC in the field of cardiovascular diseases, and discuss how to reasonably apply CEC and maximize its role in the process of the endpoint events adjudication of clinical trials.
Objective To investigate the effects of evidence-based medicine (EBM) course on clinical medical students and to propose teaching advice. Methods Using a predesigned questionnaire, we conducted an investigation on the literature retrieval, knowledge of EBM terms, and subject attitude of clinical 5-year and 7-year medical students before and after EBM course, and then an interview was performed to collect the opinions of the students. Data was statistically analyzed. Results After the course, average reading time and frequency of literature retrieval increased significantly compared to the situation before EBM course (Plt;0.05). Knowledge levels of main EBM terms related to practice increased significantly (Plt;0.05). 5-year medical students’ ability of literature appraisal also increased (Plt;0.05). In this interview, these students suggested that course time of literature retrieval and screening should increase and medical statistics should be reviewed. Conclusion Through the study of EBM course, both knowledge and attitude of students changed a lot, and combining case teaching with EBM course has a better teaching effect. Learning the concepts and techniques of EBM for clinical medical students can help them apply medical research evidence correctly in clinical practice, and train their self-learning ability.
Objective To analyze the methodological quality of clinical practice guideline mentioned “evidence-based” in China. Methods We selected clinical guidelines developed based on evidence issued by the Chinese Medical Association in 2010-2012, and meanwhile, we conducted additional search for guidelines on clinical major diseases. Then, we selected literature according to the inclusion and exclusion criteria and evaluated the included guidelines according to 8 items relevant to methodological rigor which were selected from the Appraisal of Guidelines for Research and Evaluation (AGREE II). If the guidelines comply with the item, we recorded 1 point, otherwise 0 point. Results a) Among twenty-two included guidelines, 13 were originated and 9 were updated once every 3 to 5 years. b) Diseases covered stroke, diabetes, chronic hepatitis B, hypertension, pediatric nutrition, etc. c) The number of guideline references were 10 to 218, of which, nine guidelines cited 24 Cochrane systematic reviews (CDSRs), accounted for 2.62% (24/916). Among them, the acute ischemic stroke guideline cited the most (7 CDSRs). d) The number of experts involved in guidelines development was 2 to 95 and guidelines pages were 4 to 150. e) The guidelines’ quality generally scored 4 to 7, most of which described the process of guidelines development. The grades of recommendation were consistent with the levels of evidence. But most of the included guidelines did not clearly described literature research methods, peer reviewer, and update procedures. Conclusion There is a growing trend that clinical guidelines are developed based on evidence in China. However, the quality of reporting and the methodological rigor of guidelines need further improvement. The citation rates of Cochrane systematic reviews in these guidelines were relatively low. We suggest that guideline recommendations should be consistent with the levels of evidence and adapt to local conditions, and relevant support policies for guideline implementation in practice. In future, attention should be paid to the aspects of guideline development methods, reporting standard, guideline accessibility, and standard training for relevant personnel.