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 investigate the clinical value of quick sequential organ failure assessment (qSOFA) score in predicting the outcome of patients with septic shock. MethodsWe collected the clinical data of 170 patients with septic shock treated in the Emergency Intensive Care Unit between January 2013 and January 2014. According to the 28-day outcomes of the patients, they were recorded as survival group and non-survival group. We calculated the qSOFA score, acute physiology and chronic health evaluation (APACHE)Ⅱ score on patients' admission. Using receiver operating characteristic (ROC) curve, we analyzed the qSOFA score, the effect of APACHE Ⅱ score in predicting the 28-day prognosis for patients with septic shock. The correlation between qSOFA score and APACHEⅡ score was also assessed. ResultsThe qSOFA and APACHEⅡ scores in non-survivors were higher than those in the survivors. According to ROC curve analysis, the area under the curve for qSOFA score and APACHE Ⅱ score was 0.666 and 0.791, respectively. For qSOFA score with 2 cut-off points to evaluate the prognosis of septic shock, the sensitivity was 62.7%, specificity was 61.1%, positive predictive value was 56.0%, negative predictive value was 67.4%, positive likelihood ratio was 1.61, and negative likelihood ratio was 0.61. For the APACHEⅡ score with 24 cut-off points to evaluate the prognosis of septic shock, the sensitivity was 70.7%, specificity was 80%, positive predictive value was 73.6%, negative predictive value was 67.3%, positive likelihood ratio was 3.54, and negative likelihood ratio was 0.37. The correlation coefficient of qSOFA score and APACHE Ⅱ score was 0.499. ConclusionThe qSOFA score is useful to evaluate the prognosis of the patients with septic shock early in Emergency Department.
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.
Objective To summarize the treatment outcomes of antegrade sequential anastomosis of great saphenous veins in off-pump coronary artery bypass grafting for coronary atherosclerotic heart disease. Methods A total of 116 patients with coronary atherosclerotic heart diseases underwent off-pump coronary artery bypass grafting from January 2013 to June 2015 in our hospital. There were 63 males and 53 females with a mean age of 42–80 (64.26±9.67) years. Left internal mammary artery was anastomosed to left anterior descending artery. The rest of the target vessels received antegrade sequential anastomosis of great saphenous veins with the order of proximal ascending aorta, diagonal branch, circumflex branch, obtuse marginal branch, left ventricular branch and posterior descending artery. Results All patients were performed off-pump coronary artery bypass grafting successfully without death or perioperative myocardial infarction. A total of 436 grafts were adopted with 3.75±0.53 in each patient. Three patients suffered low cardiac output syndrome, and were cured after administration of vasoactive drugs combined with the intra-aortic balloon pump. One patient suffered tardive pericardial tamponade and one acute renal failure, who were cured with disappearance of angina symptoms and increase of activities without discomfort. Conclusion Antegrade sequential anastomosis, as a safe and effective method, can reduce aortic stoma, save the length of grafts, shorten operative time and quickly restorate blood supply of myocardium in off-pump coronary artery bypass grafting.
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.
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.
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.
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.
ObjectiveTo compare the effectiveness of sequential method pure single-port lumpectomy-breast conserving surgery (SMPSL-BCS) in treating early-stage breast cancer patients with tumors in different quadrants. Methods A retrospective analysis was conducted on 200 early-stage breast cancer female patients admitted between January 2023 and December 2023. According to the quadrant where the tumor was located, the patients were allocated into the upper outer quadrant group (UO group), lower outer quadrant group (LO group), upper inner quadrant group (UI group), and lower inner quadrant group (LI group), with 50 cases in each group. There was no significant difference (P>0.05) in the baseline data, including age, body mass index, smoking history, marital status, comorbidities, affected breast side, maximum tumor diameter on ultrasound, maximum pathological tumor diameter, clinical tumor stage, molecular subtype, and disease duration. The operation time, intraoperative blood loss, postoperative drainage volume, and extubation time were recorded and compared between groups. Additionally, the occurrence of early-stage complications (1-3 months after operation; including subcutaneous fluid accumulation, incision infection, superficial skin burns) and late-stage complications (>3 months after operation; including pectoralis major muscle adhesion, changes in breast appearance and shape, sensory discomfort) were assessed. At 6 months after operation, the cosmetic outcome of breast-conserving surgery was rated for all groups. Results The UO group had the shortest operation time, followed by the UI group, LO group, and LI group, showing significant differences between groups (P<0.05). The UO group had the least intraoperative blood loss, followed by the LO group, UI group, and LI group; except for the difference between UO group and LO group, which was not significant (P>0.05), the differences between the other groups were significant (P<0.05). The UO group had the least postoperative drainage volume, followed by the LO group, UI group, and LI group; except for the difference between LO group and UI group, which was not significant (P>0.05), the differences between the other groups were significant (P<0.05). The extubation time of the LI group was significantly longer than that of the other groups (P<0.05). All patients were followed up 4-12 months, with an average of 8 months. And 193 patients were followed up more than 6 months, including 48 patients in UO group, 47 in LO group, 49 in UI group, and 49 in LI group. In the early-stage period, the LI group had a higher incidence of subcutaneous fluid accumulation after tube removal compared to the UO group and LO group (P<0.05), while there was no significant difference in the incidences of other early complications between groups (P>0.05). In the late-stage period, the LI group had significantly higher incidences of pectoralis major muscle adhesion and changes in breast appearance and shape than UO group and LO group (P<0.05), and a significantly higher incidence of sensory discomfort than UO group (P<0.05). There was no significant difference in the incidences of other late-stage complications between groups (P>0.05). At 6 months after operation, the cosmetic outcomes of breast-conserving surgery were significantly better in UO group, LO group, and UI group than in LI group (P<0.05); there was no significant difference between the other groups (P>0.05). Conclusion In the treatment of early-stage breast cancer using SMPSL-BCS, patients with tumors located in the upper outer quadrant show the best effectiveness. The effectivenesses are similar for patients with tumors in the lower outer and upper inner quadrants. However, patients with tumors in the lower inner quadrant do not experience significant advantages. Therefore, it is recommended that SMPSL-BCS should not be the first-choice surgical method for patients with tumors in the lower inner quadrant.
ObjectiveTo systematically review the association between angiotension-converting enzyme (ACE) gene insertion/deletion (I/D) polymorphism and osteoarthritis (OA) by using meta-analysis and trial sequential analysis (TSA). MethodsThe PubMed, EMbase, CNKI, CBM, VIP, and WanFang Data were searched up to October 12th, 2016 for case-control or cohort studies on the correlation between ACE I/D polymorphism and OA risk. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Then, meta-analysis and TSA analysis were performed using Stata 13.1 software and TSA v0.9 soft ware. ResultsA total of six case-control studies involving 1 165 OA patients and 1 029 controls were included. The results of meta-analysis showed that the ACE I/D was associated with OA risk (DD+DI vs. II: OR=1.72, 95%CI 1.02 to 2.90, P=0.04; DI vs. II: OR=1.65, 95%CI 1.06 to 2.56, P=0.03). Subgroup analysis of ethnicity showed that, in Caucasians, the ACE I/D was associated with OA risk (DD vs. DI+II: OR=2.10, 95%CI 1.54 to 2.85, P<0.01; DD+DI vs. II: OR=3.11, 95%CI 2.20 to 4.39, P<0.01; DD vs. II: OR=4.01, 95%CI 2.68 to 6.00, P<0.01; DI vs. II: OR=2.65, 95%CI 1.06 to 2.56, P<0.01; D vs. I: OR=2.11, 95%CI 1.72 to 2.58, P=0.73). And TSA showed that all of the cumulative Z-curve strode the conventional and TSA threshold value which suggested the result of the association between ACE I/D polymorphism and OA in Caucasians was very reliable. However, the association did not exist in Asians (DD vs. DI+II: OR=0.80, 95%CI 0.60 to 1.07, P=0.13; DD+DI vs. II: OR=1.08, 95%CI 0.87 to 1.35, P=0.49; DD vs. II: OR=0.86, 95%CI 0.62 to 1.20, P=0.38; DI vs. II: OR=1.18, 95%CI 0.93 to 1.50, P=0.19; D vs. I: OR=0.93, 95%CI 0.83 to 1.14, P=0.73). And the results of TSA displayed that all of the cumulative Z-curve did not strode both TSA threshold value and required information size line excepting for DD vs. DI+II genetic model which suggested that the sample-size in Asians was insufficient. ConclusionsThe ACE D allele maybe a risk factor for OA in Caucasians. However, the association between ACE I/D polymorphism and OA risk in Asians still need more studies to prove.