Trial sequential analysis (TSA) could be performed in both TSA software and Stata software. The implementation process of TSA in Stata needs the command of "metacumbounds" of Stata combines with the packages of "foreign" and "ldbounds" of R software. This paper briefly introduces how to implement TSA using Stata software.
ObjectiveTo systematically evaluate the efficacy of high-flow nasal cannula oxygen therapy (HFNC) in Post-extubation acute exacerbation of chronic obstructive pulmonary disease (AECOPD) patients. MethodsThe Domestic and foreign databases were searched for all published available randomized controlled trials (RCTs) about HFNC therapy in post-extubation AECOPD patients. The experimental group was treated with HFNC, while the control group was treated with non-invasive positive pressure ventilation (NIPPV). The main outcome measurements included reintubation rate. The secondary outcomes measurements included oxygenation index after extubation, length of intensive care unit (ICU) stay, mortality, comfort score and adverse reaction rate. Meta-analysis was performed by Revman 5.3 software. ResultA total of 20 articles were enrolled. There were 1516 patients enrolled, with 754 patients in HFNC group, and 762 patients in control group. The results of Meta-analysis showed that there were no significant difference in reintubation rate [RR=1.41, 95%CI 0.97 - 2.07, P=0.08] and mortality [RR=0.91, 95%CI 0.58 - 1.44, P=0.69]. Compared with NIPPV, HFNC have advantages in 24 h oxygenation index after extubation [MD=4.66, 95%CI 0.26 - 9.05, P=0.04], length of ICU stay [High risk group: SMD –0.52, 95%CI –0.74 - –0.30; Medium and low risk group: MD –1.12, 95%CI –1.56- –0.67; P<0.00001], comfort score [MD=1.90, 95%CI 1.61 - 2.19, P<0.00001] and adverse reaction rate [RR=0.22, 95%CI 0.16 - 0.31, P<0.00001]. ConclusionsCompared with NIPPV, HFNC could improve oxygenation index after extubation, shorten the length of ICU stay, effectively improve Patient comfort, reduce the occurrence of adverse reactions and it did not increase the risk of reintubation and mortality. It is suggested that HFNC can be cautiously tried for sequential treatment of AECOPD patients after extubation, especially those who cannot tolerate NIPPV.
The assumption of fixed-effects model is based on that the true effect of the each trial is same. However, the assumption of random-effects model is based on that the true effect of included trials is normal distributed. The total variance is equal to the sum of within-trial variance and between-trial variance under the random-effects model. There are many estimators of the between-trial variance. The aim of this paper is to give a brief introduction of the estimators of between-trial variance in trial sequential analysis for random-effects model.
Objective To detect the false-positive results of cumulative meta-analyses of Cochrane Urology Group with the trial sequential analysis (TSA). Methods The systematic reviews of Urology Group of The Cochrane Library were searched to collect meta-analyses with positive results. Two researchers independently screened literature and extracted data of included meta-analyses. Then, TSA was performed using TSA software version 0.9 beta. Results A total of 11 meta-analyses were included. The results of TSA showed that, 8 of 11 (72.7%) meta-analyses were potentially false-positive results for failing to surpass the trial sequential monitoring boundary and to reach the required information size. Conclusion TSA can help researchers to identify the false-positive results of meta-analyses.
摘要:目的:探讨有机磷农药中毒患者阿托品使用方法,提高抢救成功率。方法: 对2005年6月至2009年6月我院收治的有机磷农药中毒病人281例进行分组,所有患者均使用阿托品疗法,A组为2007年以后132例序贯阿托品疗法患者,B组2007年以前为常规使用静推继之肌注阿托品疗法149例患者,根据有机磷农药对胆碱酯酶复能剂的疗效分为高效组和低效组,并结合病情严重程度共分为重度有机磷农药中毒胆碱酯酶复能剂高效组、重度有机磷农药中毒胆碱酯酶复能剂低效组,轻度有机磷农药中毒胆碱酯酶复能剂高效组、轻度有机磷农药中毒胆碱酯酶复能剂低效组4组,分别从达到阿托品化时间、维持阿托品化效果、反跳和中间综合征发生率、开始撤药平均时间、总住院费用、总住院平均时间、护士劳动强度进行总结和分析。结果: 维持阿托品化疗效Ａ组与B组间有显著差异,P值lt;0.01,开始撤药平均时间、总住院平均时间、总住院费用、护士劳动强度Ａ组与B组间均有差异,P值lt;0.05,发生反跳和中间综合征发生率、达到阿托品化时间在高效组间比较无差异,低效组间比较无差异,高效组与低效组比较有显著差异,P值lt;0.01,主要与中毒药物种类和病情严重程度有关,其次与阿托品治疗方法有关。 结论: 序贯阿托品疗法治疗有机磷农药中毒优于常规使用静推继之肌注阿托品疗法。Abstract: Objective: To discussion of atropine in organophosphorus pesticide poisoning patients with the use of two different methods to improve the success rate. Methods: For June 2005 to June 2009 inour hospital a total of organophosphorus pesticide poisoning 281 cases were divided into A group and B group, All patients were using atropine therapy, 132 cases of sequential therapy in patients with atropine is divided into A group, 149 cases of routine use of intravenous injection and intramuscular injection of atropine group patients were divided into B group, From the following aspects were analyzed and summarized, They are the maintenance of the effect of atropinization, the average time for the beginning of withdrawal, the total hospitalization costs, the total average time for hospitalization and nurses labor intensity. According to the organic phosphorus pesticide on the efficacy of cholinesterase agents are divided into efficient and inefficient groups groups, From the types of poisons, toxic ways, poisoning performance and Complications for stratified, They were divided into 4 groups, severe organophosphorus pesticide poisoning and cholinesterase reactivator can be highly effective group, severe organophosphorus pesticide poisoning and cholinesterase reactivator Lowefficacy group, mild organophosphorus pesticide poisoning and cholinesterase reactivator can be highly effective group, mild organophosphorus pesticide poisoning and cholinesterase reactivator Lowefficacy group, Correlation analysis Antijumping and the incidence of intermediate syndrome and atropinization time.Results:Maintain the efficacy of atropine of A group and B were significantly different between groups, Plt;0.01, the average time began to withdraw drugs, the total average time for hospitalization, total hospital charges, nursing labor intensity of A group and B are differences between the two groups, P＜0.05. Rebound occurs and the incidence of intermediate syndrome, to atropinization time high between the two groups showed no difference between the two groups showed no differences between inefficient and efficient group and inefficient group were significantly different, Plt;0.01, mainly related to poisoning by drug type and severity of illness, followed with atropine therapy. Conclusion:Atropine sequential therapy is superior to organophosphorus pesticide poisoning by conventional atropine treatmen.
Due to the competition of new drug research and clinical requirement, speeding up drug development and marketing requires faster and more flexible clinical trial design that meets the ethical requirements. Different adaptive designs have emerged in clinical trials of different stages and purposes, for trial efficiency improvement. Adaptive design is more widely used in the field of oncology. Compared with traditional design, adaptive design is more complicated and requires higher level of methodology from researchers. Therefore, implementing adaptive design requires careful consideration and adequate preparation. This paper aims to summarize the design of adaptive methods used in different trial stages so as to provide reference for clinical research designers and implementers.
The robustness of results of statistical analysis would be altered on the condition of repeated update of traditional meta-analysis and cumulative meta-analysis. In addition, the cumulative meta-analysis lacks estimation of the sample size. While trail sequential analysis (TSA), which introduces group sequential analysis in meta-analysis, can adjust the random error and ultimately estimate the required sample size of the systematic review or meta-analysis. TSA is performed in TSA software. In the present study, we aimed to introduce how to use the TSA software for performing meta-analysis.
Cumulative meta-analysis could help researchers to justify the effectiveness of the intervention and whether the obtained evidence is sufficient. However, the process of the meta-analysis does not adjust the repeated testing of the null hypothesis and neither quantifies the statistical power. The sequential meta-analysis has solved the aforementioned problems and has been widely used in the clinical practice and decision-making. Currently several methods of sequential meta-analysis have been proposed and these methods differ from each other. Of which, the methodology of trial sequential (TSA) is well developed and corresponding performance is relatively easy; the methodology of double-triangular test of Whitehead is lagged than TSA and its performance is relatively difficult; the approach of semi-Bayes refers to the theory of Bayes and it's very difficult to generalize. Our paper aimed to give a brief introduction of the methodology of the sequential meta-analysis.
ObjectiveTo describe the effect of sequential pulmonary balloon angioplasty for patients with chronic thromboembolic pulmonary hypertension, who was accompanied with progressed pulmonary hypertension after pulmonary endarterectomy surgeries.MethodsFrom 2014 to December 2017, 7 patients were treated with a combination therapy of pulmonary endarterectomy and sequential pulmonary balloon angioplasty. There were 1 male and 6 females at age of 58 (43–59) years. A follow-up period of more than 1 year was accomplished. The result of right sided heart catheterization and ultrasonic cardiogram between and after the pulmonary endarterectomy or balloon angioplasty was collected.ResultsSeven patients were treated with a combination of pulmonary endarterectomy and sequential pulmonary balloon angioplasty, which included 1 patient of single pulmonary balloon angioplasty and 6 patients of multiple pulmonary balloon angioplasties. The balloon dilation times was 2 (2–6), and the number of segments during each single balloon dilatation was 3–5, compared with the first clinical results before the first balloon dilation, systolic pulmonary artery pressure [53 (47–75) mm Hg vs. 45 (40–54) mm Hg, P=0.042), mean pulmonaryartery pressure [38 (29–47) mm Hg vs. 29 (25–39) mm Hg, P=0.043], N terminal-B type natriuretic peptide [1 872 (1 598–2 898) pg/ml vs. 164 (72–334) pg/ml, P=0.018] improved significantly after the last balloon angioplasty. Heart function classification (NYHA) of all the 7 patients were recovered to Ⅰ-Ⅱclasses (P<0.05).ConclusionSequential pulmonary balloon angioplasty after pulmonary endarterectomy can further reduce the patient's right heart after load, improve the heart function for patients with progressed pulmonary hypertension after pulmonary endarterectomy surgeries.
Trial sequential analysis (TSA) can identify inclusive results of apparently conclusive of meta-analyses by providing require information size and monitoring boundary. Certain methods of calculating information size are existed. Our objective was to give a brief introduction of four methods to help readers to better perform TSA in making meta-analyses.