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.
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.
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.
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.
ObjectivesTo systematically review the necessary factors of questionnaires design on patients' values and preferences in order to provide information on the most appropriate questionnaires when developing clinical practice guidelines.MethodsA systematic literature search of PubMed, EMbase, The Cochrane Library, CBM, CNKI and WanFang Data databases was performed to identify studies on questionnaires evaluating patient values and preferences. The authors included the articles that used fully structured questionnaires or scales with standardized questions and answer options. We assessed the questionnaires' construction with psychometric methodology and summarized the necessary factors on patients' preferences and values into the domains and items.ResultsTwenty articles were eventually included. Five out of 20 studies (25%, 5/20) described the process of item generation while merely one questionnaire (5%, 1/20) mentioned pilot testing. Regarding validity, there were 6 questionnaires (30%, 6/20) that assessed validity. For acceptability, the time taken to complete the questionnaires range from 10 to 30 minutes and only 6 studies reported response rates. The results showed that the factors affecting the design of questionnaires on patients' values and preference were related to the effectiveness, safety, prognostic factors and others. The main factors were the effects, side effects and risk of complications, risk of relapse and the cost of treatments.ConclusionsOnly a few studies have developed questionnaires with rigorous psychometric methods to measure patients' preference and values. There is still no valid or reliable questionnaires for patients' preference and values when developing clinical practice guidelines. Further study should be conducted to develop standardized instruments to measure patients' preference and values. It is suggested that the factors this study provides can be used in formulating questionnaires on patients' preference and values.
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.
Objectives To investigate calcium supplement in pregnancy for prevention of preeclampsia and relevant outcomes. Methods The Cochrane Library, PubMed, EMbase, CBM, WanFang Data, VIP and CNKI databases were searched online to collect randomized controlled trials (RCTs) of calcium supplement in pregnancy for prevention of preeclampsia and relevant outcomes from inception to July 2018. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Meta-analysis was then performed by RevMan 5.3 software. Results A total of 33 RCTs involving 29 234 subjects were included. The results of meta-analysis showed that: compared with control group, the calcium supplement group was associated with lower preeclampsia (RR=0.48, 95%CI 0.38 to 0.62, P<0.000 01) and gestational hypertension (RR=0.65, 95%CI 0.55 to 0.77,P<0.000 01) incidence. The incidence of premature delivery, intrauterine growth retardation and severe preeclampsia in calcium supplement group was lower than that in placebo group, and the neonatal weight in calcium was higher than that in placebo group. However, there was no significant difference in the pregnancy cycle between the two groups. Conclusions Current evidence shows that calcium supplement is associated with lower risk of preeclampsia and gestational hypertension. Due to limited quality and quantity of the included studies, more high quality studies are required to verify the above conclusion.
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.
ObjectiveTo systematically review the efficacy and safety of robotic-assisted thoracic surgery (RATS) and video assisted thoracic surgery (VATS) for patients with non-small cell lung cancer (NSCLC). MethodsWe searched PubMed, EMbase, The Cochrane Library (Issue 9, 2016), Web of Science, CNKI, VIP, WanFang Data and CBM databases to collect clinical studies about RATS vs. VATS for patients with NSCLC 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 software.ResultsA total of 14 cohort studies involving 19 921 patients were included; among them, 4 322 cases were in the RATS group, and 15 599 were in the VATS group. The results of meta-analysis showed that the operation time (MD=22.90, 95%CI 9.97 to 35.84, P<0.000 5) was longer in the RATS group than the VATS group. However, the conversion rate (OR=0.72, 95%CI 0.44 to 1.18, P=0.20), the incidence of postoperative complications (OR=1.06, 95%CI 0.96 to 1.17, P=0.28), intraoperative blood loss (MD=2.75, 95%CI –8.39 to 13.89, P=0.63), postoperative hospitalization time (MD=–0.00, 95%CI –0.02 to 0.02, P=0.99) and in-hospital mortality rate (OR=0.60, 95%CI 0.35 to 1.05, P=0.07) were not significant differences between both groups.ConclusionThe current meta-analysis indicates that the efficacy and safety of RATS and VATS for NSCLC is equivalence, however the operation time for RATS is longer. Due to the limited quantity and quality of inclued studies, the above conclusions still need to be verified by more high quality studies.
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.