With the encouragement of national policy on drug and medical device innovation, multi-center clinical trials and multi-regional clinical trials are facing an unprecedented opportunity in China. Trials with a multi-center design are far more common at present than before. However, it should be recognized there still exists shortcomings in current multi-center trials. In this paper, we summarize the problems and challenges and provide corresponding resolutions with the aim to reduce heterogeneity between study centers and avoid excessive center effects in treatment. It is urgent to develop design, implementation and reporting guidelines to improve the overall quality of multi-center clinical trials.
ObjectiveTo systematically review the efficacy and safety of prostacyclin for patients with pulmonary arterial hypertension (PAH).MethodsWe searched PubMed, EMbase, The Cochrane Library, WanFang Data, CBM and CNKI databases for randomized controlled trials (RCTs) compared prostacyclin with placebo from inception to April 2018. Two reviewers independently screened literature, extracted the data and assessed the risk of bias of included studies. Then meta-analysis was performed using RevMan 5.3 software.ResultsEleven RCTs including 2 549 participants were included. The results of meta-analysis showed that, compared with placebo group, prostacyclin group was superior to the placebo group in 6-min walk distance (MD=31.10, 95%CI 16.89 to 45.30, P<0.001), mortality (RR=0.62, 95%CI 0.41 to 0.94,P=0.03), Brog score (MD=–0.88, 95%CI –1.28 to –0.49, P<0.001), mean pulmonary arterial pressure (MD=–3.31, 95%CI –4.34 to –2.29,P<0.001) and cardiac index (MD=0.32, 95%CI 0.14 to 0.51,P<0.001). However, there were no differences between two groups in reducing delaying time to clinical deterioration (RR=1.27, 95%CI 0.99 to 1.63,P=0.06), tolerability (RR=0.74, 95%CI 0.42 to 1.31, P=0.30) and pulmonary vascular resistance (MD=–4.35, 95%CI –8.85 to 0.15, P=0.06).ConclusionsCurrent evidence reveals that prostacyclin therapy appears to be superior to the placebo in reducing the mortality, improving excise capacity, respiratory and cardiac function, and ameliorating mean pulmonary arterial pressure for pulmonary arterial hypertension. However, the efficacy of prostacyclin in delaying time to clinical deterioration, tolerability and pulmonary vascular resistance for PAH is not clear. Due to the limited quality and quantity of included studies, more high quality RCTs are required for further verification.
Objective To investigate the feedback of continuing medical education (CME) based on short message service (SMS) for village doctors in Gaolan County of Gansu Province, and to explore how to improve the efficiency of CME based on SMS. Methods A total of 75 village doctors were investigated with a questionnaire when attending the training program conducted by the Health Bureau of Gaolan County. Results A total of 75 valid questionnaires were collected back. The statistical analyses showed that 56% of the doctors received the majority of the messages sent to them, of whom, 98% could read the messages promptly, 81% saved the majority of the messages they received, 98% could read the saved massages occasionally, 25% transmitted messages to others, 93% thought that the messages might be helpful in varying degrees, 96% would like to continue receiving the messages in the future, 51% thought the biggest shortcoming of the messages was the poor relevance to their concern, and 70% wanted the most to receive short messages about clinical diagnosis and treatment. At present, 39% of the doctors thought the most convenient approaches to get the updated medical knowledge are attending the study or training program organized by higher authorities, while 37% thought those are reading short messages on the mobile, websites or papers. Conclusion The village doctors are willing to receive the short messages about the best clinical evidence. However, both the receiving rate and use rate of the short messages have yet to improve. A complete SMS transmission system and highly-relevant contents are regarded as important guarantees for improving the receiving rate and use rate.
ObjectivesTo systematically review the therapeutic efficacy of vitamin B1 for adjunctive treatment in type 2 diabetes mellitus.MethodsDatabases including PubMed, EMbase, The Cochrane Library, CNKI, VIP, WanFang Data and CBM were searched to collect randomized controlled trials (RCTs) on vitamin B1 for adjunctive treatment in type 2 diabetes mellitus from inception to July 2017. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Then, meta-analysis was conducted by RevMan 5.3 and Stata 12.0 softwares. ResultsA total of 6 RCTs involving 346 patients were included. The results of meta-analysis showed that, compared with the control group, the vitamin B1 adjunctive group had a significant improvement in CRP (MD=–1.09, 95%CI –1.63 to –0.54, P<0.000 1). However, the fasting blood glucose (MD=–0.23, 95%CI –0.58 to 0.13,P=0.22), glycosylated hemoglobin (MD=0.13, 95%CI –0.25 to 0.52, P=0.49), 2 hours plasma glucose (MD=–0.18, 95%CI –1.03 to 0.67, P=0.68), systolic pressure (MD=2.94, 95%CI –1.31 to 7.18, P=0.18), diastolic pressure (MD=–1.60, 95%CI –4.24 to 1.05, P=0.24), triglycerides (MD=–0.12, 95%CI –0.32 to 0.09, P=0.27), total cholesterol (MD=0.21, 95%CI –0.05 to 0.46, P=0.12), high-density lipoprotein cholesterols (MD=0.03, 95%CI –0.07 to 0.12, P=0.56) and low-density lipoprotein cholesterols (MD=0.12, 95%CI –0.11 to 0.35, P=0.30) had no significant differences between both groups.ConclusionsVitamin B1 adjunctive treatment could not improve the levels of blood glucose, blood pressure and serum lipids. Due to limited quality and quantity of the included studies, more high quality studies are required to verify above conclusions.
ObjectiveTo systematically review safety and effectiveness of robotic Roux-en-Y gastric bypass (RYGB) and laparoscopic RYGB for morbid obesity.MethodsThe systematic literatures were conducted by a comprehensive search in the PubMed, Embase, Cochrane Library, WanFang data, CNKI, and CBM, etc. Two reviewers independently selected the literatures and extracted the data. The meta-analysis was performed using the R statistical program version 3.4.2.ResultsA total of 19 studies involving 177 766 patients with morbid obesity were included, of which 172 234 underwent the laparoscopic RYGB (laparoscopic group) and 5 532 underwent the robotic RYGB (robotic group). The operative time was longer [MD=27.84, 95% CI (12.85, 42.83)] and the rate of death was higher [OR=2.05, 95% CI (1.03, 4.08)] in the robotic group as compared with the laparoscopic group. The hospitalization time, intraoperative blood loss, conversion rate, rates of reoperation and readmission of 30 d after the operation, and postoperative complications had no significant differences between these two groups.ConclusionRobotic RYGB is a safe and effective surgical procedure, but it is not found to be superior to laparoscopic RYGB.
Objective By investigating the employment situation and intentions of medical students, to provide scientific evidence for guiding students’ employment by relevant departments, and to give references for formulating reasonable medical personnel training and distribution policy by health administrations. Methods The medical students of Grade 2005 in Lanzhou University were investigated by using a self-designed questionnaire. Results Among 397 questionnaires distributed, 337 were returned (84.8%). The analyses showed, when hunting a job, 45% of the respondents thought the “opportunities for personal development” was the most important factor, 61% thought the influence of parents’ or family’s desires was “greater” or “extremely greater”, 85% thought the job matching their majors was “important” or “very important”, 57% thought it is “easier” to get a content job by their majors, 51% held that the “fewer opportunities” were the most unfavorable conditions for working in township hospitals, 68% wouldn’t directly choose township hospitals after graduation, and 67% still gave up the choice even if an official position was provided. Conclusion The medical students attach great importance to the opportunities for their personal development, but they lack self-consciousness in choosing the occupation. They are optimistic about the employment but lack passion for primary hospitals. Meanwhile, they aren’t familiar with national policy guidance; their employment fields are narrow.
ObjectivesTo evaluate the reporting quality of clinical practice guidelines published in Chinese journals in 2015.MethodsCBM, CNKI, VIP and WanFang Data databases were searched to collect clinical practice guidelines published in Chinese journals from January, 2015 to December, 2015. Two reviewers independently screened literature, extracted data, and the reporting quality of clinical practice guidelines were evaluated by the Reporting Items for Practice Guidelines in Healthcare (RIGHT). Excel software was used for data analysis.ResultsA total of 74 clinical practice guidelines were included. It was found that among the seven domains of RIGHT, the reporting quality of basic information and background domains were acceptable. There were fewer problems in the domain of evidence and recommendation. There were many deficiencies in three domains, such as review and quality assurance, funding and the declaration/management of interests and other information.ConclusionsThe reporting quality of clinical practice guidelines published in Chinese journals in 2015 is low, and the full reporting rate of clinical practice guidelines need to be improved. It is suggested that guideline developers construct strict guidelines for the development and report the guidelines with international standard, thus improving the quality of the clinical practice guidelines.
Objective To investigate the decision-making situation of doctors in the township hospitals in Gaolan, Gansu province, and to discuss its scientificity and rationality. Methods Self-designed questionnaire was adopted to investigate the clinical decision-making situation of 108 doctors from 7 township hospitals in Gaolan county. The investigation contained three parts as follows: basic information of respondents, general information of clinical decision-making evidence, and comparison between respondents’ decision-making situation and current best clinical evidence. Results Among the total 108 questionnaires distributed, 89 valid were retrieved. The feedback showed that 79% of the doctors diagnosed and treated patients in accordance with medical textbooks; 53% took curative effect into consideration in the first place; 33% failed to consider patients’ willingness properly when making clinical decisions; and 52% made clinical therapy regimen for common diseases based on the evidence which was different from that in BMJ published Clinical Evidence. Conclusion While making clinical decisions, doctors in the township hospitals do not adequately refer to the best clinical evidence as their decision-making basis, and fail to take patients’ value and willingness into consideration properly. It is necessary to promote the concept of evidence-based medicine and spread the best evidence in the township health departments.
ObjectiveTo systematically review the efficacy and safety of robotic-assisted hepatectomy (RAH) versus traditional laparoscopic hepatectomy (TLH) for hepatic neoplasms.MethodsDatabases including PubMed, EMbase, The Cochrane Library, Web of Science, CNKI, WanFang Data and CBM databases were electronically searched to collect cohort studies about the RAH vs. the TLH for liver neoplasms from inception to December 10th, 2016. Two reviewers independently screened the literatures, extracted data and assessed the risk of bias of the included studies. And finally, a meta-analysis was performed by using RevMan 5.3 software.ResultsA total of 17 studies involving 1 389 patients were included. The meta-analysis results showed that: compared to TLH group, RAH group was associated with more estimated blood loss (WMD=39.56, 95%CI 4.65 to 74.47, P=0.013), longer operative time SMD=0.55, 95%CI 0.29 to 0.80, P<0.001), and later in the first nutritional intake time (SMD=1.06, 95%CI 0.66 to 1.45,P<0.001). However, there were no significant differences in the length of hospital stay, conversion to laparotomy, intraoperative blood transfusion, resection rate of tumor margin, complications and 90-day mortality between the two groups.ConclusionCurrent evidence indicates that TLH is superior to RAH in terms of operative time, intraoperative blood loss and the first nutritional intake time, but there are no statistically significant differences in the primary outcomes, suggesting that RAH and TLH have similar efficacy and safety for hepatic neoplasms. Due to the limitation of quality and quantity of the included studies, the above conclusions need to be verified by more high-quality research.
Objectives
To assess the relationship between subclinical hyperthyroidism and the incidence of coronary heart disease (CHD).
Methods
PubMed, EMbase, The Cochrane Library, Web of Science, CNKI, VIP, WanFang Data and CBM databases were searched for studies on the relationship between subclinical hyperthyroidism and the incidence of CHD from inception to October 2016. Two reviewers independently screened literature, extracted data, and assessed the risk of bias of included studies. Then, meta-analysis was performed by using RevMan 5.3 and Stata 12.0 software.
Results
In total, 14 cohort studies were included. The results of meta-analysis showed that subclinical hyperthyroidism was associated with the incidence of coronary heart disease (RR=1.19, 95%CI 1.01 to 1.40, P=0.04) and all-cause mortality (RR=1.36, 95%CI 1.11 to 1.67, P=0.003).
Conclusions
Subclinical hyperthyroidism is associated with an increased risk of CHD and all-cause mortality. Due to the limitation of quality and quantity of the studies, the above conclusions are required to be verified by large-scale and high quality research.
