Although the evidence from randomized controlled trials (RCTs) is regarded as a golden standard, it often fails to be applied in clinical practice for lack of generalizability. Evidence from either RCTs or non-RCTs is mutually complementary and referred. Different designs are suitable for different stages and can resolve different issues. During evaluation of an intervention, the proper research design should be selected in accordance with the objective, feasibility, and merits and limitations of different design modes.
Randomized controlled trials (RCTs) are the gold standard for the design of clinical trials. Because of some practical difficulties, more and more researchers think that the appropriate use of non-randomized controlled trials may make up for the weakness of RCT and will achieve the same research purpose. Therefore, non-RCTs are also very important. Taking studies on multiple sclerosis for example, this article briefly introduces the significance of non-randomized contolled trials.
ObjectivesThe aim of this meta-analysis was to evaluate the adjuvant efficacy of dendritic cell (DC) vaccines against advanced colorectal cancer.MethodsCNKI, CBM, WanFang Data, VIP, PubMed, Web of Science, The Cochrane Library and EMbase were searched to identify studies on dendritic cell vaccine for CRC up to August 13rd, 2017. After independently screening the literature and extracting data, two researchers evaluated the risk of bias in the studies, and used RevMan 5.3.5 software for meta-analysis.ResultsA total of 10 studies involving 2 050 patients were included. Meta-analysis showed that cellular immunotherapy based on DC vaccine treatment can improve the 2-year and 3-year overall survival rate of patients with advanced colorectal cancer (HR=0.33, 95%CI 0.17 to 0.27; 0.26, 95%CI 0.12 to 0.56, P<0.05), while there was no statistically significant difference in 1-year overall survival rate (HR=0.48, 95%CI 0.19 to 1.20, P=0.12); DC-CIK-based cellular immunotherapy could improve 2-year and 3-year overall survival rates (HR=0.27, 95%CI 0.10 to 0.75; HR=0.15, 95%CI 0.04 to 0.54, P<0.05), the difference of 1-year overall survival rate was not statistically significant (HR=0.39, 95%CI 0.13 to 1.13, P=0.08); DC combined with chemotherapy could improve 2-year and 3-year overall survival (HR=0.24, 95%CI 0.10 to 0.56; HR=0.22, 95%CI 0.04 to 0.54, P<0.05); the difference of 1-year overall survival rate was not statistically significant (HR=0.34, 95%CI 0.06 to 2.03, P=0.24); median overall survival in the DC vaccine group (MSR=1.25, 95%CI 1.16 to 1.34, P<0.05) and median progression-free survival (MSR=1.39, 95%CI 1.25 to 1.53, P<0.05) were superior to the control group. Fever was the most common adverse reaction and most patients could be relieved after treatment.ConclusionsDendritic cells vaccines-based immunotherapy can effectively improve the later overall survival rate and prolong median OS of patients with advanced colorectal cancer with mild adverse reactions, however the improvement of short term survival rate is not obvious.
ObjectivesTo systematically evaluate the efficacy and safety of 1 470 nm laser vaporization vs. transurethral resection of prostate (TURP) for benign prostatic hyperplasia (BPH).MethodsPubMed, EMbase, The Cochrane Library, CBM, CNKI, WanFang Data and VIP databases were electronically searched to collect randomized controlled trials (RCTs) and non-randomized controlled trials (non-RCTs) about the efficacy and safety of 1 470 nm laser vaporization vs. TURP for BPH from inception to October 22nd, 2018. 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 6 RCTs and 4 non-RCTs were included. The results of meta-analysis showed that: 1 470 nm laser vaporization was superior to TURP in reducing intraoperative bleeding (MD=−103.87, 95%CI −148.08 to −59.65, P<0.000 01), hospital stay (MD=−3.82, 95%CI −4.35 to −3.28, P<0.000 01), postoperative indwelling catheter time (MD=−2.24, 95%CI −3.45 to −1.02, P=0.000 3), postoperative hemoglobin (MD=−1.63, 95%CI −3.14 to −0.12, P=0.03) and rate of secondary hemorrhage (OR=0.13, 95%CI 0.03 to 0.48, P=0.002). There were no significant differences in operative time, bladder irrigation time, transient urinary incontinence and urethral stricture, IPSS Score and Qmax at 3 months after operation between the two groups (P>0.05).ConclusionCurrent evidence shows that 1 470 nm laser vaporization is superior to TURP in reducing intraoperative bleeding and secondary hemorrhage. It may be more suitable for prostate surgery in anticoagulant or coagulative dysfunction patients. Due to limited quality and quantity of the included studies, more high quality studies are required to verify above conclusions.
Traditional randomized controlled trial and real-world study have different advantages in internal validity and external extensibility, respectively. With the development of evidence-based health decisions, randomized controlled trial was no longer the only golden standard of interventional study, the research evidence of the real world was gradually involved in health decisions. This study mainly analyzed the requirements of evidence and actual application of evidence in the evaluation of the effectiveness of NICE in the UK. It was found that NICE still used the results of randomized controlled trials as a primary basis. Although real-world research has developed rapidly in recent years, it was limited used in health decision because of its bias by design and other factors. However, in recent years, real-world evidence has played a significant role in the field of innovative drugs or diseases that lack therapeutic drugs. With the improvement of real-world research in experimental design and data analysis, it is expected that it will play a more important role in health decision-making.
ObjectivesTo systematically review the efficacy and safety of mechanical thrombectomy for patients with acute ischemic stroke in different ages.MethodsPubMed, EMbase, The Cochrane Library, Web of Science, CNKI, and WanFang Data databases were electronically searched to collect randomized controlled trials (RCTs) and non-randomized controlled trials (non-RCTs) on the efficacy and safety of mechanical thrombectomy for patients with acute ischemic stroke in different ages from inception to August, 2019. Two reviewers independently screened literature, extracted data and assessed risk of bias of included studies, then, meta-analysis was performed by using Stata 12.0 software.ResultsA total of 13 studies involving 2 995 patients were included. The results of meta-analysis showed that compared with the control group, patients aged 80 and above had no statistically significant difference in reperfusion success rates (OR=0.90, 95%CI 0.71 to 1.14, P=0.378), and incidence of symptomatic intracranial hemorrhage (OR=1.30, 95%CI 0.86 to 1.94, P=0.212), however, with higher incidence of arbitrary intracranial bleeding events (OR=1.61, 95%CI 1.28 to 2.04, P<0.001), 3-month mortality (OR=2.14, 95%CI 1.73 to 2.64, P<0.001) and lower good functional prognosis rate at 3 months (OR=0.46, 95%CI 0.30 to 0.71, P<0.001).ConclusionsCurrent evidence suggests that people aged 80 and above can obtain effective perfusion through mechanical thrombectomy, however, the incidence of postoperative adverse outcome events is higher and the prognosis is relatively poor. Due to limited quality and quantity of the included studies, more high-quality studies are required to verify above conclusions.