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 investigate the effectiveness of debridement-vacuum sealing drainage (VSD)-modified external fixation antibiotic-impregnated cement semi-open technique in treatment of chronic ulcer wounds. MethodsClinical data of 43 patients with chronic ulcer wounds who met the selection criteria and admitted between January 2019 and June 2023 were retrospectively analyzed. Among them, 23 cases were treated with debridement-VSD-modified external fixation antibiotic-impregnated cement semi-open technique (improved group), and 20 cases were treated with debridement-VSD-traditional antibiotic-impregnated cement technique (control group). There was no significant difference in gender, age, constituent ratio of patients with type 2 diabetes mellitus, constituent ratio of patients with smoking history, body mass index, wound site, and other baseline data between the two groups (P>0.05). The healing quality and healing time, the positive rate of bacterial culture after bone cement coating, the loosening rate of bone cement, the number of operations, the number of hospitalizations, the length of hospitalization, and the cost of hospitalization were recorded and compared between the two groups. Results Compared with the control group, the positive rate of bacterial culture after bone cement coating and the loosening rate of bone cement in the improved group was significantly lower, as well as the number of operations, the number of hospitalizations, the length of hospitalization, and hospitalization cost significantly reduced (P<0.05). Wound repair was completed in both groups without amputation. The wound healing quality of the improved group was better than that of the control group and the wound healing time was shorter, the differences were significant (P<0.05). All patients were followed up 1-5 years (mean 3.4 years), and no ulcers recurred during follow-up. ConclusionDebridement-VSD-modified external fixation antibiotic-impregnated cement semi-open technique in the treatment of chronic ulcer wounds can effectively reduce the loosening rate of bone cement, facilitate the induced membrane formation and wound healing, and significantly reduce the number of operations and shorten the length of hospital stay.
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.
Trial Sequential Analysis (TSA), one kind of cumulative meta-analysis, is a method which introduces sequential analysis into traditional meta-analysis to avoid random errors (false positive or false negative outcomes) that occurred during repeated updates when traditional meta-analysis is performing. It is also applied to calculate required information size (RIS) of a firm conclusion. This study aims to summarize the proposal, fundamental theory, application software, and current limitation of TSA, and to clarify the advantages of TSA on the basis of detailed examples, in order to attract more attention of researchers and promote the methodological development of meta-analysis in China.
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.
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.
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.
Objective To explore the feasibility and effectiveness of perforator propeller flap sequential transfer technique in repair of soft tissue defect of distal lower extremity. Methods Between July 2015 and July 2021, 10 patients with soft tissue defect of distal lower extremity were treated with perforator propeller flap sequential transfer technique. There were 8 males and 2 females, with a median age of 47 years (range, 6-71 years). The etiologies included malignant tumor in 5 cases, trauma in 3 cases, postburn scar contracture in 1 case, and diabetic foot ulcer in 1 case. The defects were located at the pretibial area in 1 case, the distal lower extremity and Achilles tendon in 3 cases, the dorsum of foot and lateral malleolar area in 4 cases, the heel in 1 case, and the plantar foot in 1 case. The size of the defect ranged from 5 cm×3 cm to 8 cm×8 cm. Peroneal artery perforator propellor flaps (the 1st flap) in size of 14 cm×4 cm to 29 cm×8 cm were used to repair the defects of distal lower extremity. The donor site defects were repaired with the other perforator propeller flaps (the 2nd flap) in size of 7 cm×3 cm to 19 cm×7 cm. The donor site of the 2nd flap was directly closed. ResultsAll the operations were successfully completed and all of the 2nd flaps were elevated within 1 hour. Eight the 1st flaps survived completely; 2 had venous congestion. Among the 2 patients with venous congestion, 1 had necrosis of the distal end of the flap, and the secondary wound was repaired by skin grafting; 1 recovered spontaneously after 7 days. The 2nd flaps totally survived. No complication such as hematoma or infection occurred. Primary closure was achieved in all the recipient and donor sites. All patients were followed up 2-39 months, with a median of 15.5 months. The color, texture, and thickness of the flaps matched well with those of recipient sites. The normal contour of the leg was preserved. During follow-up, no recurrence of malignance or ulcer was observed. The scar contracture was completely released. All patients were satisfied with the reconstructive outcomes. Conclusion The application of the perforator propeller flap sequential transfer technique can improve the repair ability of the lower extremity perforator propeller flap while ensuring the first-stage closure of the donor site, thereby improving the effectiveness.
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.
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.