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Leonardi-Bee, J. "Trial Sequential Analysis." International Journal of Evidence-Based Healthcare 14, no. 4 (2016): 194. http://dx.doi.org/10.1097/01.xeb.0000511335.64918.e6.
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Yang, Shengping, and Gilbert Berdine. "Trial sequential analysis." Southwest Respiratory and Critical Care Chronicles 11, no. 47 (2023): 63–67. http://dx.doi.org/10.12746/swrccc.v11i47.1175.
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Chai-Adisaksopha, Chatree, Kristian Thorlund, and Alfonso Iorio. "Interpreting trial sequential analysis." Transfusion 56, no. 12 (2016): 2918–22. http://dx.doi.org/10.1111/trf.13910.
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Kang, Hyun. "Trial sequential analysis: novel approach for meta-analysis." Anesthesia and Pain Medicine 16, no. 2 (2021): 138–50. http://dx.doi.org/10.17085/apm.21038.
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Systematic reviews and meta-analyses rank the highest in the evidence hierarchy. However, they still have the risk of spurious results because they include too few studies and participants. The use of trial sequential analysis (TSA) has increased recently, providing more information on the precision and uncertainty of meta-analysis results. This makes it a powerful tool for clinicians to assess the conclusiveness of meta-analysis. TSA provides monitoring boundaries or futility boundaries, helping clinicians prevent unnecessary trials. The use and interpretation of TSA should be based on an understanding of the principles and assumptions behind TSA, which may provide more accurate, precise, and unbiased information to clinicians, patients, and policymakers. In this article, the history, background, principles, and assumptions behind TSA are described, which would lead to its better understanding, implementation, and interpretation.
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Barakji, Jehad, Steven Kwasi Korang, Joshua Feinberg, et al. "Cannabinoids versus placebo for pain: A systematic review with meta-analysis and Trial Sequential Analysis." PLOS ONE 18, no. 1 (2023): e0267420. http://dx.doi.org/10.1371/journal.pone.0267420.
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Objectives To assess the benefits and harms of cannabinoids in participants with pain. Design Systematic review of randomised clinical trials with meta-analysis, Trial Sequential Analysis, and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Data sources The Cochrane Library, MEDLINE, Embase, Science Citation Index, and BIOSIS. Eligibility criteria for selecting studies Published and unpublished randomised clinical trials comparing cannabinoids versus placebo in participants with any type of pain. Main outcome measures All-cause mortality, pain, adverse events, quality of life, cannabinoid dependence, psychosis, and quality of sleep. Results We included 65 randomised placebo-controlled clinical trials enrolling 7017 participants. Fifty-nine of the trials and all outcome results were at high risk of bias. Meta-analysis and Trial Sequential Analysis showed no evidence of a difference between cannabinoids versus placebo on all-cause mortality (RR 1.20; 98% CI 0.85 to 1.67; P = 0.22). Meta-analyses and Trial Sequential Analysis showed that cannabinoids neither reduced acute pain (mean difference numerical rating scale (NRS) 0.52; 98% CI -0.40 to 1.43; P = 0.19) or cancer pain (mean difference NRS -0.13; 98% CI -0.33 to 0.06; P = 0.1) nor improved quality of life (mean difference -1.38; 98% CI -11.81 to 9.04; P = 0.33). Meta-analyses and Trial Sequential Analysis showed that cannabinoids reduced chronic pain (mean difference NRS -0.43; 98% CI -0.72 to -0.15; P = 0.0004) and improved quality of sleep (mean difference -0.42; 95% CI -0.65 to -0.20; P = 0.0003). However, both effect sizes were below our predefined minimal important differences. Meta-analysis and Trial Sequential Analysis indicated that cannabinoids increased the risk of non-serious adverse events (RR 1.20; 95% CI 1.15 to 1.25; P < 0.001) but not serious adverse events (RR 1.18; 98% CI 0.95 to 1.45; P = 0.07). None of the included trials reported on cannabinoid dependence or psychosis. Conclusions Cannabinoids reduced chronic pain and improved quality of sleep, but the effect sizes are of questionable importance. Cannabinoids had no effects on acute pain or cancer pain and increased the risks of non-serious adverse events. The harmful effects of cannabinoids for pain seem to outweigh the potential benefits.
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Al-Rudayni, Ali Hatem Manfi, Divya Gopinath, Mari Kannan Maharajan, Sajesh K. Veettil, and Rohit Kunnath Menon. "Efficacy of Photobiomodulation in the Treatment of Cancer Chemotherapy-Induced Oral Mucositis: A Meta-Analysis with Trial Sequential Analysis." International Journal of Environmental Research and Public Health 18, no. 14 (2021): 7418. http://dx.doi.org/10.3390/ijerph18147418.
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Oral mucositis is a debilitating complication of chemotherapy, characterized by erythema, ulcers and oedema of the oral mucosa. This review aimed to evaluate the efficacy of Photobiomodulation in the treatment of oral mucositis using meta-analysis and trial sequential analysis, and also to assess the quality of the results by Grading of Recommendations, Assessment, Development and Evaluation (GRADE). A comprehensive search of three databases, including Embase, Medline and Central, was performed to identify randomized controlled trials studying the efficacy of Photobiomodulation in the treatment of cancer chemotherapy-induced oral mucositis. The primary outcome was reduction in the severity of oral mucositis. Secondary outcomes were pain relief, duration of oral mucositis and adverse effects. The meta-analysis was performed using the random-effects model, and random errors of the meta-analyses were detected by trial sequential analysis. A total of 6 randomized controlled trials with 398 participants were included in our analysis. Photobiomodulation significantly reduced the severity of oral mucositis when compared to sham radiation (RR 0.43, 95% CI 0.20 to 0.93; p < 0.05). Sensitivity analysis by excluding trials with high risk of bias reiterated the robustness of our results (RR 0.28, 95% CI 0.16 to 0.48). Trial sequential analysis illustrated that the evidence from the meta-analysis was conclusive. The result of the meta-analyses with trial sequential analysis illustrated that Photobiomodulation is an effective therapeutic intervention for the treatment of oral mucositis, and the evidence gathered can be considered conclusive with a moderate level of certainty according to GRADE. Further trials are recommended to standardize the laser parameters required for the optimal effect.
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Alfirevic, Z., and S. Gates. "Trial sequential analysis: useful or useless?" BJOG: An International Journal of Obstetrics & Gynaecology 127, no. 10 (2020): 1227–28. http://dx.doi.org/10.1111/1471-0528.16282.
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Kulinskaya, Elena, and John Wood. "Trial sequential methods for meta-analysis." Research Synthesis Methods 5, no. 3 (2013): 212–20. http://dx.doi.org/10.1002/jrsm.1104.
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Geller, N. L. "Planned interim analysis and its role in cancer clinical trials." Journal of Clinical Oncology 5, no. 9 (1987): 1485–90. http://dx.doi.org/10.1200/jco.1987.5.9.1485.
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Although interim analyses in cancer clinical trials are commonplace, clinical trials are usually designed with the implicit assumption that data analysis will occur only after the trial is completed. The design of randomized trials with planned interim analyses, "group sequential trials," is described and examples are given. A method to redesign trials in which unplanned interim analyses have been undertaken is described. Planned interim analysis should be considered whenever a cancer clinical trial is designed.
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Maurya, Indubala, Ayush Lohiya, and Ashish Solanki. "Trial sequential analysis: Quality improvement for meta-analysis." Indian Journal of Anaesthesia 68, no. 12 (2024): 1092–94. https://doi.org/10.4103/ija.ija_1051_24.
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Juul, Sophie, Emil Eik Nielsen, Joshua Feinberg, et al. "Interventions for treatment of COVID-19: Second edition of a living systematic review with meta-analyses and trial sequential analyses (The LIVING Project)." PLOS ONE 16, no. 3 (2021): e0248132. http://dx.doi.org/10.1371/journal.pone.0248132.
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Background COVID-19 is a rapidly spreading disease that has caused extensive burden to individuals, families, countries, and the world. Effective treatments of COVID-19 are urgently needed. This is the second edition of a living systematic review of randomized clinical trials assessing the effects of all treatment interventions for participants in all age groups with COVID-19. Methods and findings We planned to conduct aggregate data meta-analyses, trial sequential analyses, network meta-analysis, and individual patient data meta-analyses. Our systematic review was based on PRISMA and Cochrane guidelines, and our eight-step procedure for better validation of clinical significance of meta-analysis results. We performed both fixed-effect and random-effects meta-analyses. Primary outcomes were all-cause mortality and serious adverse events. Secondary outcomes were admission to intensive care, mechanical ventilation, renal replacement therapy, quality of life, and non-serious adverse events. According to the number of outcome comparisons, we adjusted our threshold for significance to p = 0.033. We used GRADE to assess the certainty of evidence. We searched relevant databases and websites for published and unpublished trials until November 2, 2020. Two reviewers independently extracted data and assessed trial methodology. We included 82 randomized clinical trials enrolling a total of 40,249 participants. 81 out of 82 trials were at overall high risk of bias. Meta-analyses showed no evidence of a difference between corticosteroids versus control on all-cause mortality (risk ratio [RR] 0.89; 95% confidence interval [CI] 0.79 to 1.00; p = 0.05; I2 = 23.1%; eight trials; very low certainty), on serious adverse events (RR 0.89; 95% CI 0.80 to 0.99; p = 0.04; I2 = 39.1%; eight trials; very low certainty), and on mechanical ventilation (RR 0.86; 95% CI 0.55 to 1.33; p = 0.49; I2 = 55.3%; two trials; very low certainty). The fixed-effect meta-analyses showed indications of beneficial effects. Trial sequential analyses showed that the required information size for all three analyses was not reached. Meta-analysis (RR 0.93; 95% CI 0.82 to 1.07; p = 0.31; I2 = 0%; four trials; moderate certainty) and trial sequential analysis (boundary for futility crossed) showed that we could reject that remdesivir versus control reduced the risk of death by 20%. Meta-analysis (RR 0.82; 95% CI 0.68 to 1.00; p = 0.05; I2 = 38.9%; four trials; very low certainty) and trial sequential analysis (required information size not reached) showed no evidence of difference between remdesivir versus control on serious adverse events. Fixed-effect meta-analysis showed indications of a beneficial effect of remdesivir on serious adverse events. Meta-analysis (RR 0.40; 95% CI 0.19 to 0.87; p = 0.02; I2 = 0%; two trials; very low certainty) showed evidence of a beneficial effect of intravenous immunoglobulin versus control on all-cause mortality, but trial sequential analysis (required information size not reached) showed that the result was severely underpowered to confirm or reject realistic intervention effects. Meta-analysis (RR 0.63; 95% CI 0.35 to 1.14; p = 0.12; I2 = 77.4%; five trials; very low certainty) and trial sequential analysis (required information size not reached) showed no evidence of a difference between tocilizumab versus control on serious adverse events. Fixed-effect meta-analysis showed indications of a beneficial effect of tocilizumab on serious adverse events. Meta-analysis (RR 0.70; 95% CI 0.51 to 0.96; p = 0.02; I2 = 0%; three trials; very low certainty) showed evidence of a beneficial effect of tocilizumab versus control on mechanical ventilation, but trial sequential analysis (required information size not reached) showed that the result was severely underpowered to confirm of reject realistic intervention effects. Meta-analysis (RR 0.32; 95% CI 0.15 to 0.69; p < 0.00; I2 = 0%; two trials; very low certainty) showed evidence of a beneficial effect of bromhexine versus standard care on non-serious adverse events, but trial sequential analysis (required information size not reached) showed that the result was severely underpowered to confirm or reject realistic intervention effects. Meta-analyses and trial sequential analyses (boundary for futility crossed) showed that we could reject that hydroxychloroquine versus control reduced the risk of death and serious adverse events by 20%. Meta-analyses and trial sequential analyses (boundary for futility crossed) showed that we could reject that lopinavir-ritonavir versus control reduced the risk of death, serious adverse events, and mechanical ventilation by 20%. All remaining outcome comparisons showed that we did not have enough information to confirm or reject realistic intervention effects. Nine single trials showed statistically significant results on our outcomes, but were underpowered to confirm or reject realistic intervention effects. Due to lack of data, it was not relevant to perform network meta-analysis or possible to perform individual patient data meta-analyses. Conclusions No evidence-based treatment for COVID-19 currently exists. Very low certainty evidence indicates that corticosteroids might reduce the risk of death, serious adverse events, and mechanical ventilation; that remdesivir might reduce the risk of serious adverse events; that intravenous immunoglobin might reduce the risk of death and serious adverse events; that tocilizumab might reduce the risk of serious adverse events and mechanical ventilation; and that bromhexine might reduce the risk of non-serious adverse events. More trials with low risks of bias and random errors are urgently needed. This review will continuously inform best practice in treatment and clinical research of COVID-19. Systematic review registration PROSPERO CRD42020178787.
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NeCamp, Timothy, Amy Kilbourne, and Daniel Almirall. "Comparing cluster-level dynamic treatment regimens using sequential, multiple assignment, randomized trials: Regression estimation and sample size considerations." Statistical Methods in Medical Research 26, no. 4 (2017): 1572–89. http://dx.doi.org/10.1177/0962280217708654.
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Cluster-level dynamic treatment regimens can be used to guide sequential treatment decision-making at the cluster level in order to improve outcomes at the individual or patient-level. In a cluster-level dynamic treatment regimen, the treatment is potentially adapted and re-adapted over time based on changes in the cluster that could be impacted by prior intervention, including aggregate measures of the individuals or patients that compose it. Cluster-randomized sequential multiple assignment randomized trials can be used to answer multiple open questions preventing scientists from developing high-quality cluster-level dynamic treatment regimens. In a cluster-randomized sequential multiple assignment randomized trial, sequential randomizations occur at the cluster level and outcomes are observed at the individual level. This manuscript makes two contributions to the design and analysis of cluster-randomized sequential multiple assignment randomized trials. First, a weighted least squares regression approach is proposed for comparing the mean of a patient-level outcome between the cluster-level dynamic treatment regimens embedded in a sequential multiple assignment randomized trial. The regression approach facilitates the use of baseline covariates which is often critical in the analysis of cluster-level trials. Second, sample size calculators are derived for two common cluster-randomized sequential multiple assignment randomized trial designs for use when the primary aim is a between-dynamic treatment regimen comparison of the mean of a continuous patient-level outcome. The methods are motivated by the Adaptive Implementation of Effective Programs Trial which is, to our knowledge, the first-ever cluster-randomized sequential multiple assignment randomized trial in psychiatry.
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Taylor, Paul Geoffrey, Kwee-Yum Lee, Raul Landeo, Damien Michael O'Meara, and Emma Millett. "Determining optimal trial size using sequential analysis." Journal of Sports Sciences 33, no. 3 (2014): 300–308. http://dx.doi.org/10.1080/02640414.2014.942679.
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Christensen, Erik. "Effective randomized clinical trial design: sequential analysis." Journal of Hepatology 38, no. 4 (2003): 550–51. http://dx.doi.org/10.1016/s0168-8278(03)00048-5.
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Xu Duan-Zheng and Shi Jun. "Computers: Computer analysis of the sequential trial." Trends in Pharmacological Sciences 7 (January 1986): 258–59. http://dx.doi.org/10.1016/0165-6147(86)90343-3.
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Koretz, Ronald L. "JPEN Journal Club 50. Trial Sequential Analysis." Journal of Parenteral and Enteral Nutrition 44, no. 4 (2020): 729–32. http://dx.doi.org/10.1002/jpen.1753.
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Lin, Jin-Wei, Chung-Ting Chen, Ming-Shun Hsieh, et al. "Percutaneous catheter drainage versus percutaneous needle aspiration for liver abscess: a systematic review, meta-analysis and trial sequential analysis." BMJ Open 13, no. 7 (2023): e072736. http://dx.doi.org/10.1136/bmjopen-2023-072736.
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ObjectiveTo compare the effectiveness and safety of percutaneous catheter drainage (PCD) against percutaneous needle aspiration (PNA) for liver abscess.DesignSystematic review, meta-analysis and trial sequential analysis.Data sourcesPubMed, Web of Science, Cochrane Library, Embase, Airiti Library and ClinicalTrials.gov were searched from their inception up to 16 March 2022.Eligibility criteriaRandomised controlled trials that compared PCD to PNA for liver abscess were considered eligible, without restriction on language.Data extraction and synthesisPrimary outcome was treatment success rate. Depending on heterogeneity, either a fixed-effects model or a random-effects model was used to derive overall estimates. Review Manager V.5.3 software was used for meta-analysis. Trial sequential analysis was performed using the Trial Sequential Analysis software. Certainty of evidence was evaluated using the Grading of Recommendations, Assessment, Development and Evaluation system.ResultsTen trials totalling 1287 individuals were included. Pooled analysis revealed that PCD, when compared with PNA, enhanced treatment success rate (risk ratio 1.16, 95% CI 1.07 to 1.25). Trial sequential analysis demonstrated this robust finding with required information size attained. For large abscesses, subgroup analysis favoured PCD (test of subgroup difference, p<0.001). In comparison to PNA, pooled analysis indicated a significant benefit of PCD on time to achieve clinical improvement or complete clinical relief (mean differences (MD) −2.53 days; 95% CI −3.54 to –1.52) in six studies with 1000 patients; time to achieve a 50% reduction in abscess size (MD −2.49 days; 95% CI −3.59 to –1.38) in five studies with 772 patients; and duration of intravenous antibiotic use (MD −4.04 days, 95% CI −5.99 to −2.10) in four studies with 763 patients. In-hospital mortality and complications were not different.ConclusionIn patients with liver abscess, ultrasound-guided PCD raises the treatment success rate by 136 in 1000 patients, improves clinical outcomes by 3 days and reduces the need for intravenous antibiotics by 4 days.PROSPERO registration numberCRD42022316540.
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Flynn, Darren, Richard Francis, Kristoffer Halvorsrud, et al. "Intra-arterial mechanical thrombectomy stent retrievers and aspiration devices in the treatment of acute ischaemic stroke: A systematic review and meta-analysis with trial sequential analysis." European Stroke Journal 2, no. 4 (2017): 308–18. http://dx.doi.org/10.1177/2396987317719362.
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Purpose Intra-arterial mechanical thrombectomy combined with appropriate patient selection (image-based selection of acute ischaemic stroke patients with large artery occlusion) yields improved clinical outcomes. We conducted a systematic review and meta-analysis, with trial sequential analysis to understand the benefits, risks and impact of new trials reporting in 2016 on the magnitude/certainty of the estimates for clinical effectiveness and safety of mechanical thrombectomy. Method Random effects’ models were conducted of randomised clinical trials comparing mechanical thrombectomy (stent retriever or aspiration devices) with/without adjuvant intravenous thrombolysis with intravenous thrombolysis and other forms of best medical/supportive care in the treatment of acute ischaemic stroke. Study inclusion and risk of bias were assessed independently by two reviewers. Functional independence (modified Rankin Scale 0–2) and mortality at 90 days, including symptomatic intracranial haemorrhage rate were extracted. Trial sequential analysis established the strength of the evidence derived from the meta-analyses. Findings Eight trials of mechanical thrombectomy with a total sample size of 1841 (916 patients treated with mechanical thrombectomy and 925 treated without mechanical thrombectomy) fulfilled review inclusion criteria. The three most recent trials more precisely defined the effectiveness of mechanical thrombectomy (modified Rankin Scale 0 to 2; OR = 2.07, 95% CI = 1.70 to 2.51 based on data from eight trials versus OR = 2.39, 95% CI = 1.88 to 3.04 based on data from five trials). Meta-analyses showed no effect on mortality (OR = 0.81, 95% CI = 0.61 to 1.07) or symptomatic intracranial haemorrhage (OR = 1.22, 95% CI = 0.80 to 1.85) as found in analysis of first five trials. Trial sequential analysis indicated that the information size requirement was fulfilled to conclude the evidence for mechanical thrombectomy is robust. Discussion The impact of three recent trials on effectiveness and safety of mechanical thrombectomy was a more precise pooled effect size for functional independence. Trial sequential analysis demonstrated sufficient evidence for effectiveness and safety of mechanical thrombectomy. Conclusion No further trials of mechanical thrombectomy versus no mechanical thrombectomy are indicated to establish clinical effectiveness. Uncertainty remains as to whether mechanical thrombectomy reduces mortality or increases risk of symptomatic intracranial haemorrhage.
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Nair, Abhijit, and Nitin K. Borkar. "Understanding the trial sequential analysis graph in meta-analysis." Saudi Journal of Anaesthesia 18, no. 1 (2024): 162–64. http://dx.doi.org/10.4103/sja.sja_715_23.
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Miladinovic, Branko, Ambuj Kumar, Rahul Mhaskar, Helen Mahoney, Keith Wheatley, and Benjamin Djulbegovic. "Trial Sequential Analysis in Meta-Analyses of Maintenance Therapies for Multiple Myeloma." Blood 120, no. 21 (2012): 2975. http://dx.doi.org/10.1182/blood.v120.21.2975.2975.
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Abstract Abstract 2975 Background: Meta-analyses (MAs) with few participants (i.e. small number of primary studies) are at risk of producing random errors and consequently overestimating treatment effects. With insufficient information the risk of obtaining a false positive result (type I error) increases, which may lead to false conclusions. Trial sequential analysis (TSA) has been proposed as a method to ascertain whether results of MAs are conclusive (true vs. false positive, true vs. false negative). It adjusts for the risk of random error by constructing monitoring boundaries under the sample size necessary to conclude significant treatment effect. In TSA, the information size is calculated based on a pre-specified event rate in the control group, a minimum intervention effect (risk ratio reduction), and a desired maximum risk of type I error α and type II error β. Here we apply TSA on MAs of randomized controlled trials of maintenance therapies in the management of multiple myeloma. Methods: A comprehensive literature search of MEDLINE (PubMed), the Cochrane Central Register of Controlled Trials (CENTRAL), and meetings abstracts from American Society of Hematology, American Society of Clinical Oncology, European Society for Medical Oncology and European Hematology Association was undertaken to identify all phase III randomized controlled trials (RCTs) of maintenance therapy published until July 2012. We extracted data on overall survival and progression-free survival comparing treatments that could be pooled in random effects meta-analysis. We performed TSA for the apriori diversity-adjusted information size (APDIS) under risk ratio reduction of 20% and 25%. The information size was adjusted for between-study trial diversity, which is defined as the total relative variance expansion changing from a fixed effect into a random effects meta-analysis. We used two-sided α = 5% and 1 – β = 80% power. All analyses were done in Stata 11.2 using metacumbounds command. Results: Nine separate meta-analyses (18 randomized controlled trials) met the inclusion criteria (Table 1). The median number of patients was 1193 (range 351–2824) and median diversity 0% (range 0%-91%). Under both risk ratio reductions of 20% and 25%, 4/9 MAs were false negative and 1/9 false positive. The observed power based on the accrued sample size and observed risk ratio reduction was greater than 80% in 5/9 MAs. Conclusion: TSA detected one false positive MA of two trials comparing thalidomide with prednisone/dexamethosone for the outcome of overall survival. Future MAs need to consistently undertake TSA to avoid misleading conclusions. Disclosures: No relevant conflicts of interest to declare.
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Grayling, Michael J., James MS Wason, and Adrian P. Mander. "Group sequential designs for stepped-wedge cluster randomised trials." Clinical Trials 14, no. 5 (2017): 507–17. http://dx.doi.org/10.1177/1740774517716937.
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Background/Aims: The stepped-wedge cluster randomised trial design has received substantial attention in recent years. Although various extensions to the original design have been proposed, no guidance is available on the design of stepped-wedge cluster randomised trials with interim analyses. In an individually randomised trial setting, group sequential methods can provide notable efficiency gains and ethical benefits. We address this by discussing how established group sequential methodology can be adapted for stepped-wedge designs. Methods: Utilising the error spending approach to group sequential trial design, we detail the assumptions required for the determination of stepped-wedge cluster randomised trials with interim analyses. We consider early stopping for efficacy, futility, or efficacy and futility. We describe first how this can be done for any specified linear mixed model for data analysis. We then focus on one particular commonly utilised model and, using a recently completed stepped-wedge cluster randomised trial, compare the performance of several designs with interim analyses to the classical stepped-wedge design. Finally, the performance of a quantile substitution procedure for dealing with the case of unknown variance is explored. Results: We demonstrate that the incorporation of early stopping in stepped-wedge cluster randomised trial designs could reduce the expected sample size under the null and alternative hypotheses by up to 31% and 22%, respectively, with no cost to the trial’s type-I and type-II error rates. The use of restricted error maximum likelihood estimation was found to be more important than quantile substitution for controlling the type-I error rate. Conclusion: The addition of interim analyses into stepped-wedge cluster randomised trials could help guard against time-consuming trials conducted on poor performing treatments and also help expedite the implementation of efficacious treatments. In future, trialists should consider incorporating early stopping of some kind into stepped-wedge cluster randomised trials according to the needs of the particular trial.
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Yoder, Whitney, Floris Groenendaal, Wes Onland, Anna van Oploo, Charlotte Rietbergen, and Rolf Groenwold. "Sequential co-enrolment in randomised trials in neonatal intensive care medicine." Archives of Disease in Childhood - Fetal and Neonatal Edition 105, no. 2 (2019): 128–31. http://dx.doi.org/10.1136/archdischild-2019-316818.
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In many medical research settings, such as the neonatal intensive care unit, the number of patients who are eligible for a randomised clinical trial is relatively small and recruiting a sufficient number of patients into trials is often difficult. Furthermore, some infants may have already been enrolled into a trial as a fetus. Sequential co-enrolment of patients into more than one trial may offer a solution, yet runs the risk of contaminated results. We consider the situation of two sequential trials and describe requirements for different possible treatments effects (‘estimands’) to be estimated in such situations. These estimands differ regarding the extent to which participation status and treatment status in the previous trial is accounted for. Because of differences in available information about previous trials, analyses may result in estimated effects which differ in terms of interpretation and generalisability, except when in the absence of an interaction between the studied treatments. If co-enrolment cannot be ruled out, researchers should collect information about co-enrolment and treatment status in a previous or concurrent trial and mitigate the trial analysis plan in order to estimate meaningful effects.
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Maratea, Dario, Valeria Fadda, Sabrina Trippoli, and Andrea Messori. "Glutamine in critically ill patients: Trial-sequential analysis." Clinical Nutrition 33, no. 4 (2014): 735–36. http://dx.doi.org/10.1016/j.clnu.2014.02.004.
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Shah, A., and A. F. Smith. "Trial sequential analysis: adding a new dimension to meta‐analysis." Anaesthesia 75, no. 1 (2019): 15–20. http://dx.doi.org/10.1111/anae.14705.
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Tan, Nannan, Yiqing Cai, Junjie Liu, et al. "Effects and Safety of Oral Iron for Heart Failure with Iron Deficiency: A Systematic Review and Meta-Analysis with Trial Sequential Analysis." Cardiovascular Therapeutics 2022 (September 17, 2022): 1–16. http://dx.doi.org/10.1155/2022/6442122.
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Background. Oral iron supplement is commonly prescribed to heart failure patients with iron deficiency. However, the effects of oral iron for heart failure remain controversial. This study included randomized controlled trials (RCTs) for meta-analysis to evaluate the effects of oral iron for heart failure patients. Methods. Nine databases (The Cochrane Library, Embase, PubMed, CINAHL, Web of science, CNKI, SinoMed, VIP, and Wanfang) were searched for RCTs of oral iron for heart failure from inception to October 2021. The effects were assessed with a meta-analysis using Revman 5.3 software. The trial sequential analysis was performed by TSA 0.9.5.10 beta software. The risk of bias of trials was evaluated via Risk of Bias tool. The evidence quality was assessed through GRADE tool. Results. Four studies including 582 patients with heart failure and iron deficiency were enrolled. The results indicated that oral iron treatment could improve left ventricular ejection fraction (LVEF, MD = 1.52 % , 95% CI: 0.69 to 2.36, P = 0.0003 ) and serum ferritin ( MD = 1.64 , 95% CI: 0.26 to 3.02, P = 0.02 ). However, there was no between-group difference in the 6-minute walk distances (6MWT), N terminal pro B type natriuretic peptide (NT-proBNP) or hemoglobin level when compared with control group. Subgroup analyses revealed that the effects of oral iron on 6 MWT and serum ferritin could not be affected by duration and frequency of oral iron uptakes. In trial sequential analysis of LVEF and serum ferritin, the Z-curves crossed the traditional boundary and trail sequential monitoring boundary but did not reach the required information size. Conclusion. This analysis showed that oral iron could improve cardiac function measured by LVEF, and iron stores measured serum ferritin, but lack of effect on exercise capacity measured by 6 MWT, and iron stores measured by hemoglobin. Given the overall poor methodological quality and evidence quality, these findings should be treated cautiously.
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Al-Rudayni, Ali Hatem Manfi, Divya Gopinath, Mari Kannan Maharajan, Sajesh Kalkandi Veettil, and Rohit Kunnath Menon. "Efficacy of Oral Cryotherapy in the Prevention of Oral Mucositis Associated with Cancer Chemotherapy: Systematic Review with Meta-Analysis and Trial Sequential Analysis." Current Oncology 28, no. 4 (2021): 2852–67. http://dx.doi.org/10.3390/curroncol28040250.
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Background: This review aimed to evaluate the efficacy of oral cryotherapy in the prevention of chemotherapy-induced oral mucositis using meta-analysis and trial sequential analysis, as well as to assess the quality of the results by the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. Methods: A comprehensive search of three databases including Medline, Embase and Central was performed to identify randomized controlled trials that used oral cryotherapy for the prevention of chemotherapy-induced oral mucositis. The primary outcome was the incidence of oral mucositis for trials employing oral cryotherapy as the intervention for the prevention of oral mucositis. The meta-analysis was performed using the random-effects model and random errors of the meta-analyses were detected by trial sequential analysis. Results: A total of 14 RCTs with 1577 participants were included in the present meta-analysis. Patients treated with oral cryotherapy were associated with a significantly lower risk of developing oral mucositis of any grade (risk ratio (RR), 0.67 (95% CI: 0.56–0.81, p < 0.05)). Findings from the subgroup analyses showed that oral cryotherapy significantly reduced the risk of oral mucositis in patients undergoing bone marrow transplantation (RR 0.69, CI: 0.54–0.89, p < 0.05) as well as chemotherapy (RR 0.66, CI: 0.58–0.75, p < 0.05). Findings from the trial sequential analysis suggested that the evidence on oral cryotherapy as a preventive intervention for oral mucositis in patients with solid malignancies receiving conventional chemotherapy was conclusive. Conclusion: Oral cryotherapy is effective in preventing oral mucositis in patients undergoing chemotherapy for the management of solid malignancies. The use of oral cryotherapy in preventing oral mucositis in bone marrow transplantation settings showed promising efficacy, but the evidence is not conclusive and requires more high-quality randomized controlled trials.
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Xu, Chongxi, Tong Yi, Siwen Tan, et al. "Association of Oral or Intravenous Vitamin C Supplementation with Mortality: A Systematic Review and Meta-Analysis." Nutrients 15, no. 8 (2023): 1848. http://dx.doi.org/10.3390/nu15081848.
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Mortality is the most clinically serious outcome, and its prevention remains a constant struggle. This study was to assess whether intravenous or oral vitamin C (Vit-C) therapy is related to reduced mortality in adults. Data from Medline, Embase, and the Cochrane Central Register databases were acquired from their inception to 26 October 2022. All randomized controlled trials (RCTs) involving intravenous or oral Vit-C against a placebo or no therapy for mortality were selected. The primary outcome was all-cause mortality. Secondary outcomes were sepsis, COVID-19, cardiac surgery, noncardiac surgery, cancer, and other mortalities. Forty-four trials with 26540 participants were selected. Although a substantial statistical difference was observed in all-cause mortality between the control and the Vit-C-supplemented groups (p = 0.009, RR 0.87, 95% CI 0.78 to 0.97, I2 = 36%), the result was not validated by sequential trial analysis. In the subgroup analysis, mortality was markedly reduced in Vit-C trials with the sepsis patients (p = 0.005, RR 0.74, 95% CI 0.59 to 0.91, I2 = 47%), and this result was confirmed by trial sequential analysis. In addition, a substantial statistical difference was revealed in COVID-19 patient mortality between the Vit-C monotherapy and the control groups (p = 0.03, RR 0.84, 95% CI 0.72 to 0.98, I2 = 0%). However, the trial sequential analysis suggested the need for more trials to confirm its efficacy. Overall, Vit-C monotherapy does decrease the risk of death by sepsis by 26%. To confirm Vit-C is associated with reduced COVID-19 mortality, additional clinical random control trials are required.
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Flight, Laura, Steven Julious, Alan Brennan, and Susan Todd. "Expected Value of Sample Information to Guide the Design of Group Sequential Clinical Trials." Medical Decision Making 42, no. 4 (2021): 461–73. http://dx.doi.org/10.1177/0272989x211045036.
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Introduction Adaptive designs allow changes to an ongoing trial based on prespecified early examinations of accrued data. Opportunities are potentially being missed to incorporate health economic considerations into the design of these studies. Methods We describe how to estimate the expected value of sample information for group sequential design adaptive trials. We operationalize this approach in a hypothetical case study using data from a pilot trial. We report the expected value of sample information and expected net benefit of sampling results for 5 design options for the future full-scale trial including the fixed-sample-size design and the group sequential design using either the Pocock stopping rule or the O’Brien-Fleming stopping rule with 2 or 5 analyses. We considered 2 scenarios relating to 1) using the cost-effectiveness model with a traditional approach to the health economic analysis and 2) adjusting the cost-effectiveness analysis to incorporate the bias-adjusted maximum likelihood estimates of trial outcomes to account for the bias that can be generated in adaptive trials. Results The case study demonstrated that the methods developed could be successfully applied in practice. The results showed that the O’Brien-Fleming stopping rule with 2 analyses was the most efficient design with the highest expected net benefit of sampling in the case study. Conclusions Cost-effectiveness considerations are unavoidable in budget-constrained, publicly funded health care systems, and adaptive designs can provide an alternative to costly fixed-sample-size designs. We recommend that when planning a clinical trial, expected value of sample information methods be used to compare possible adaptive and nonadaptive trial designs, with appropriate adjustment, to help justify the choice of design characteristics and ensure the cost-effective use of research funding. Highlights Opportunities are potentially being missed to incorporate health economic considerations into the design of adaptive clinical trials. Existing expected value of sample information analysis methods can be extended to compare possible group sequential and nonadaptive trial designs when planning a clinical trial. We recommend that adjusted analyses be presented to control for the potential impact of the adaptive designs and to maintain the accuracy of the calculations. This approach can help to justify the choice of design characteristics and ensure the cost-effective use of limited research funding.
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Zhang, Yang, Qiong Xu, Feng Zhang, and Chunlei Sun. "Probiotics for Preventing Necrotizing Enterocolitis: A Meta-Analysis with Trial Sequential Analysis." Journal of Clinical Pharmacy and Therapeutics 2023 (May 8, 2023): 1–15. http://dx.doi.org/10.1155/2023/8626191.
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What is Known and Objective. The role of probiotics, especially the different genera of probiotics, in managing necrotizing enterocolitis (NEC) is controversial. Thus, we performed a meta-analysis with trial sequential analysis (TSA) to determine the efficacy and safety of probiotics for preventing NEC. Methods. Medline, Embase, CENTRAL, WorldCat, TROVE, DART-Europe, and CBM were searched from inception to May 2022. Two investigators independently screened the literature, extracted data, and assessed the quality of the included studies. Meta-analysis was performed using RevMan 5.4, and TSA was conducted using TSA 0.9 beta. Results and Discussion. Fifty-five studies involving 12897 newborns were eligible. The use of probiotics for preventing NEC reduced the incidence of NEC (RR 0.48, 95% CI 0.41 to 0.57, and P < 0.05) and sepsis (RR 0.77, 95% CI 0.64 to 0.94, and P < 0.05), the risk of mortality (RR 0.69, 95% CI 0.58 to 0.84, and P < 0.05), and shortened the average days of hospitalization (MD −3.12, 95% CI −4.98 to −1.26, and P < 0.05). However, subgroup analysis revealed that different genera of probiotics gave rise to different outcomes. In addition, TSA indicated that the cumulative z-curve crossed the traditional and trial sequential monitoring boundaries for benefit, providing firm evidence that multiple strains and Lactobacillus species of probiotics decreased the incidence of NEC. However, the current evidence was inconclusive for Bifidobacterium and Saccharomyces species. What is New and Conclusions. Probiotics are effective in preventing NEC and sepsis and could provide added benefits, including decreasing mortality and the number of days of hospitalization. However, considering the heterogeneity of probiotics regimens and the risk of selective reporting of RCTs, more high-quality clinical trials targeting different genera of probiotics with suitable doses and timing to prophylactic use of probiotics are needed to avoid overestimating the role of probiotics in preterm infants.
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Wang, Xiaoqin, Liang Yao, Long Ge, et al. "Pharmacological interventions for preventing post-operative atrial fibrillation in patients undergoing cardiac surgery: a network meta-analysis protocol." BMJ Open 7, no. 12 (2017): e018544. http://dx.doi.org/10.1136/bmjopen-2017-018544.
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IntroductionPostoperative atrial fibrillation (POAF) is the most common complication following cardiac surgery, and randomised clinical trials (RCTs) and systematic reviews have been conducted to compare and evaluate different pharmacological interventions for preventing POAF. This study aimed to explore the effect of different pharmacological interventions for prophylaxis against POAF after cardiac surgery using network meta-analysis (NMA).Methods and analysisA systematic search will be performed in PubMed, EMBASE and the Cochrane Library to identify RCTs, systematic reviews, meta-analyses or NMA of different pharmacological interventions for POAF. We will evaluate the risk of bias of the included RCTs according to the Cochrane Handbook V.5.1.0, and use GRADE to assess the quality of evidence. Standard pairwise meta-analysis, trial sequential analysis and Bayesian network meta-analysis will be used to compare the efficacy of different pharmacological interventions.Ethics and disseminationEthics approval and patient consent are not required as this study is a meta-analysis based on published studies. The results of this NMA and trial sequential analysis will be submitted to a peer-reviewed journal for publication.Protocol registration numberCRD42017067492.
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Wei, Li, Hui Han, Jie Meng, Xin Li, and Qing-Ping Yao. "Meta-analysis and sequential analysis of acupuncture compared to carbamazepine in the treatment of trigeminal neuralgia." World Journal of Clinical Cases 12, no. 22 (2024): 5083–93. http://dx.doi.org/10.12998/wjcc.v12.i22.5083.
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BACKGROUND In this randomized controlled trial (RCT) comparing current acupuncture with carbamazepine for trigeminal neuralgia, meta- and sequential analyses were utilized. AIM To guide clinical decision making regarding the treatment of trigeminal neuralgia with carbamazepine. METHODS The RCT literature on needle comparison was searched in various Chinese biomedical databases including Chinese Biomedical Literature Database, Wanfang Data, VIP Database, as well as international databases such as Excerpt Medica Database, Cochrane Library, PubMed, and Web of Science, along with related clinical registration platforms such as World Health Organization International Clinical Trial Registry Platform, ChiCTR, and Clinical Trials up to 1 April 2020. Risk of bias was evaluated using the Cochrane Collaborative Risk Bias tool, primary outcome measures (pain reduction) were analyzed using STATA meta-analysis, outcome measures were analyzed using trial sequential analysis 0.9.5.10 Beta sequential analysis, GRADE was used to assess the evidence, and adverse reactions were documented. RESULTS This study analyzed 16 RCTs with a total of 1231 participants. The meta-analysis revealed a statistically significant difference in pain reduction between acupuncture and carbamazepine [standardized mean difference (SMD) = 1.47; 95% confidence interval (CI): (0.99; 1.95)], although the quality of evidence was deemed to be of extremely low quality. Cumulative meta-analysis based on the year of publication indicated that carbamazepine treatment first demonstrated a statistically significant difference in pain reduction in 2014 and remained relatively stable over time [SMD = 1.84; 95%CI: (0.22; 3.47)]. Additionally, the number of adverse events associated with acupuncture was significantly lower compared to carbamazepine. CONCLUSION Acupuncture for trigeminal neuralgia is better than analgesia and safer than carbamazepine; however, firm conclusions still require a high-quality, multicenter, large-sample RCT to confirm these findings.
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Jalalzadeh, Hasti, Allard S. Timmer, Dennis R. Buis, et al. "Triclosan-Containing Sutures for the Prevention of Surgical Site Infection." JAMA Network Open 8, no. 3 (2025): e250306. https://doi.org/10.1001/jamanetworkopen.2025.0306.
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ImportanceInternational guidelines recommend the use of triclosan-containing sutures for the prevention of surgical site infections. However, controversy still remains about triclosan-containing suture use in clinical practice since several new randomized clinical trials (RCTs) have shown contradicting results.ObjectiveTo update a previous systematic review and meta-analysis of the association of triclosan-containing sutures with surgical site infections and explore the potential added value of new RCTs.Data SourcesPubMed, Embase, and Cochrane CENTRAL databases were searched from January 1, 2015, to March 14, 2023. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guideline was followed.Study SelectionPublished RCTs comparing triclosan-containing sutures with similar sutures without triclosan for the prevention of surgical site infections in any type of surgery were included.Data Extraction and SynthesisTwo authors (H.J. and A.S.T.) independently extracted and pooled data in a random-effects (Mantel-Haenszel) model. The certainty of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluation approach, and trial sequential analysis was used to estimate whether further studies would reveal different outcomes.Main Outcomes and MeasuresThe primary outcome was the incidence of surgical site infections, expressed as relative risk (RRs) and corresponding 95% CIs. Secondary outcomes were the incidence of surgical site infections according to depth (superficial incisional, deep incisional, and organ/space) and adverse events related to triclosan-containing sutures.ResultsThe systematic review yielded 15 additional RCTs compared with a previous published review in 2017. A meta-analysis of 31 studies including 17 968 participants (62% male) undergoing various types of surgery was performed. Use of triclosan-containing sutures was associated with fewer surgical site infections compared with sutures without triclosan (RR, 0.75; 95% CI, 0.65-0.86). The certainty of evidence was moderate after downgrading for heterogeneity (τ2 = 0.04; I2 = 43%). In the trial sequential analysis of all trials and a sensitivity analysis excluding studies with a high risk of bias, the cumulative z curve crossed the trial sequential monitoring boundary for benefit, confirming the robustness of the summary effect estimate.Conclusions and RelevanceThis updated meta-analysis found moderate-certainty evidence that wound closure with triclosan-containing sutures was associated with a lower risk of surgical site infections. The trial sequential analysis suggests that future trials that would change these findings are improbable.
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Messori, Andrea, Valeria Fadda, Dario Maratea, and Sabrina Trippoli. "Maintenance Chemotherapy in Ovarian Cancer: A Trial-Sequential Analysis." Journal of Cancer Therapy 04, no. 07 (2013): 1242–43. http://dx.doi.org/10.4236/jct.2013.47145.
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Chan, Jeffrey Shi Kai, and Dawnie Ho Hei Lau. "Does lysing make life better? A trial sequential analysis." Journal of Neurology 267, no. 6 (2020): 1842–45. http://dx.doi.org/10.1007/s00415-020-09801-8.
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Krogh, Jesper, Carsten Hjorthøj, Helene Speyer, Christian Gluud, and Merete Nordentoft. "Exercise for patients with major depression: a systematic review with meta-analysis and trial sequential analysis." BMJ Open 7, no. 9 (2017): e014820. http://dx.doi.org/10.1136/bmjopen-2016-014820.
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ObjectivesTo assess the benefits and harms of exercise in patients with depression.DesignSystematic reviewData sourcesBibliographical databases were searched until 20 June 2017.Eligibility criteria and outcomesEligible trials were randomised clinical trials assessing the effect of exercise in participants diagnosed with depression. Primary outcomes were depression severity, lack of remission and serious adverse events (eg, suicide) assessed at the end of the intervention. Secondary outcomes were quality of life and adverse events such as injuries, as well as assessment of depression severity and lack of remission during follow-up after the intervention.ResultsThirty-five trials enrolling 2498 participants were included. The effect of exercise versus control on depression severity was −0.66 standardised mean difference (SMD) (95% CI −0.86 to −0.46; p<0.001; grading of recommendations assessment, development and evaluation (GRADE): very low quality). Restricting this analysis to the four trials that seemed less affected of bias, the effect vanished into −0.11 SMD (−0.41 to 0.18; p=0.45; GRADE: low quality). Exercise decreased the relative risk of no remission to 0.78 (0.68 to 0.90; p<0.001; GRADE: very low quality). Restricting this analysis to the two trials that seemed less affected of bias, the effect vanished into 0.95 (0.74 to 1.23; p=0.78). Trial sequential analysis excluded random error when all trials were analysed, but not if focusing on trials less affected of bias. Subgroup analyses found that trial size and intervention duration were inversely associated with effect size for both depression severity and lack of remission. There was no significant effect of exercise on secondary outcomes.ConclusionsTrials with less risk of bias suggested no antidepressant effects of exercise and there were no significant effects of exercise on quality of life, depression severity or lack of remission during follow-up. Data for serious adverse events and adverse events were scarce not allowing conclusions for these outcomes.Systematic review registrationThe protocol was published in the journalSystematic Reviews: 2015; 4:40.
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Maclaren, Robert, Sterling Torian, Tyree Kiser, Scott Mueller, and Paul Reynolds. "Therapeutic Hypothermia Following Cardiopulmonary Arrest: A Systematic Review and Meta-Analysis with Trial Sequential Analysis." Journal of Critical Care Medicine 9, no. 2 (2023): 64–72. http://dx.doi.org/10.2478/jccm-2023-0015.
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ABSTRACT Introduction The risk-benefit profile of therapeutic hypothermia is controversial with several randomized controlled trials providing conflicting results. Aim of Study The purpose of this systematic review and meta-analysis was to determine if therapeutic hypothermia provides beneficial neurologic outcomes relative to adverse effects. Material and Methods MEDLINE and EMBASE databases were searched for randomized controlled trials of post-cardiac arrest patients comparing therapeutic hypothermia (~33 degrees Celsius) to normothermia or the standard of care (36 - 38 degrees Celsius). Data were collected using the Covidence systematic review software. Statistical analysis was performed by Review Manager software. Risk of bias, sensitivity, and heterogeneity were analyzed using the Cochran’s Collaboration tool, trial sequential analysis (TSA) software, and I2 statistic respectively. Results A total of 1825 studies were screened and 5 studies (n=3614) were included. No significant differences existed between the hypothermia group and normothermia for favorable neurologic outcome (risk ratio [RR] 1.17, 95% confidence interval [CI] 0.97 to 1.41) or all-cause mortality (RR 0.97, 95% CI 0.89 to 1.05). When compared to normothermia, the hypothermia group had greater risk of adverse effects (RR 1.16, 95% CI 1.04 to 1.28), which was driven by the onset of arrhythmias. Subgroup analyses revealed that therapeutic hypothermia provided greater neurologic benefit in trials with a higher percentage of subjects with shockable rhythms (RR 0.73, 95% CI 0.6 to 0.88). Trial sequential analysis revealed statistical futility for therapeutic hypothermia and favorable neurologic outcome, mortality, and adverse effects. Conclusions Therapeutic hypothermia does not provide consistent benefit in neurologic outcome or mortality in the general cardiac arrest population. Patients with shockable rhythms may show favorable neurologic outcome with therapeutic hypothermia and further investigation in this population is warranted. Any potential benefit associated with therapeutic hypothermia must be weighed against the increased risk of adverse effects, particularly the onset of arrhythmias.
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Jin, Zhaosheng, Thomas Durrands, Ru Li, Tong Joo Gan, and Jun Lin. "Pectoral block versus paravertebral block: a systematic review, meta-analysis and trial sequential analysis." Regional Anesthesia & Pain Medicine 45, no. 9 (2020): 727–32. http://dx.doi.org/10.1136/rapm-2020-101512.
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BackgroundPectoral (PECs) block was first described by Blanco et al for postoperative analgesia in breast surgery. It was proposed to be an easier and safer alternative to thoracic epidural or paravertebral block (PVB). In this systematic review and meta-analysis, we compare the perioperative analgesic efficacy and adverse events of PECs block and PVB.MethodsWe systematically searched PubMed, Central, EMBASE, CINAHL, Google Scholar, Web of Science citation index, US clinical trials register, Wanfang database, as well as recent conference abstracts, for clinical studies comparing the two techniques. Analgesic efficacy was assessed according to the time to first rescue analgesia and 24 hours opioid consumption. Adverse events from the trials were recorded and reported descriptively.ResultsThe literature search was last updated on 20 February 2020. We identified a total of 10 randomized controlled trials (RCTs) comparing PECs to PVB with 252 and 250 patients, respectively. There was no difference in 24 hours opioid consumption between PECs and PVB. There was no significant difference in the time to rescue analgesia between the two cohorts. The most common adverse event noted was postoperative nausea and vomiting). Trial sequence analysis indicate that further studies are unlikely to alter the conclusion regarding opioid requirement.ConclusionOur systematic review suggests that PECs and PVB are comparable in postoperative analgesia efficacy for mastectomy, and further studies are unlikely to alter the conclusion. The choice of technique should, therefore, be based on practitioner skill and institutional guidelines.PROSPERO registration numberCRD42020165137.
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Early, Jonathan, Jessica Aalders, Elizabeth Arnott, Claire Wade, and Paul McGreevy. "Sequential Analysis of Livestock Herding Dog and Sheep Interactions." Animals 10, no. 2 (2020): 352. http://dx.doi.org/10.3390/ani10020352.
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Livestock herding dogs are crucial contributors to Australian agriculture. However, there is a dearth of empirical studies of the behavioural interactions between dog and livestock during herding. A statistical approach that may reveal cause and effect in such interactions is lag sequential analysis. Using 48 video recordings of livestock herding dogs and sheep in a yard trial competition, event-based (time between behaviours is irrelevant) and time-based (time between behaviours is defined) lag sequential analyses identified several significant behavioural interactions (adjusted residuals greater than 2.58; the maximum likelihood-ratio chi-squared statistic for all eight contingency tables identified all sequences as highly significant (p < 0.001)). These sequences were: The dog ceasing all movement followed by the sheep also ceasing movement; the dog chasing the sheep and a group of sheep escaping the main flock; a single sheep escaping the flock and the dog chasing; sheep initiating movement followed by the dog following; foot-stamping followed by the dog ceasing all movement; and, foot-stamping by the sheep and the dog lip-licking in response. Log linear regression identified significant relationships among undesirable behaviours in sheep and both observed trial duration (p = 0.001) and trial score (p = 0.009). No differences in the herding styles of dogs were identified between sex of dog and frequency of sheep escape behaviours (p = 0.355) nor the sex of dog and competition level (p = 0.116). The identification of trial score as a predictor of efficient performance confirms the benefits of incorporating extant objective measures to assess livestock herding dogs.
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Mütze, Tobias, Ekkehard Glimm, Heinz Schmidli, and Tim Friede. "Group sequential designs with robust semiparametric recurrent event models." Statistical Methods in Medical Research 28, no. 8 (2018): 2385–403. http://dx.doi.org/10.1177/0962280218780538.
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Robust semiparametric models for recurrent events have received increasing attention in the analysis of clinical trials in a variety of diseases including chronic heart failure. In comparison to parametric recurrent event models, robust semiparametric models are more flexible in that neither the baseline event rate nor the process inducing between-patient heterogeneity needs to be specified in terms of a specific parametric statistical model. However, implementing group sequential designs in the robust semiparametric model is complicated by the fact that the sequence of Wald statistics does not follow asymptotically the canonical joint distribution. In this manuscript, we propose two types of group sequential procedures for a robust semiparametric analysis of recurrent events. The first group sequential procedure is based on the asymptotic covariance of the sequence of Wald statistics and it guarantees asymptotic control of the type I error rate. The second procedure is based on the canonical joint distribution and does not guarantee asymptotic type I error rate control but is easy to implement and corresponds to the well-known standard approach for group sequential designs. Moreover, we describe how to determine the maximum information when planning a clinical trial with a group sequential design and a robust semiparametric analysis of recurrent events. We contrast the operating characteristics of the proposed group sequential procedures in a simulation study motivated by the ongoing phase 3 PARAGON-HF trial (ClinicalTrials.gov identifier: NCT01920711) in more than 4600 patients with chronic heart failure and a preserved ejection fraction. We found that both group sequential procedures have similar operating characteristics and that for some practically relevant scenarios, the group sequential procedure based on the canonical joint distribution has advantages with respect to the control of the type I error rate. The proposed method for calculating the maximum information results in appropriately powered trials for both procedures.
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Miksad, Rebecca A., Mithat Gönen, Thomas J. Lynch, and Thomas G. Roberts. "Interpreting Trial Results in Light of Conflicting Evidence: A Bayesian Analysis of Adjuvant Chemotherapy for Non–Small-Cell Lung Cancer." Journal of Clinical Oncology 27, no. 13 (2009): 2245–52. http://dx.doi.org/10.1200/jco.2008.16.2586.
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PurposeWhen successive randomized trials contradict prior evidence, clinicians may be unsure how to evaluate them: Does accumulating evidence warrant changing practice? An increasingly popular solution, Bayesian statistics quantitatively evaluate new results in context. This study provides a clinically relevant example of Bayesian methods.MethodsThree recent non–small-cell lung cancer adjuvant chemotherapy trials were evaluated in light of prior conflicting data. Results were used from International Adjuvant Lung Trial (IALT), JBR.10, and Adjuvant Navelbine International Trialist Association (ANITA). Prior evidence was sequentially updated to calculate the probability of each survival benefit level (overall and by stage) and variance. Sensitivity analysis was performed using expert opinion and uninformed estimates of survival benefit prior probability.ResultsThe probability of a 4% survival benefit increased from 33% before IALT to 64% after IALT. After sequential updating with JBR.10 and ANITA, this probability was 82% (hazard ratio = 0.84; 95% CI, 0.77 to 0.91). IALT produced the largest decrease in variance (61%) and decreased the chance of survival decrement to 0%. Sensitivity analysis did not support a survival benefit after IALT. However, sequential updating substantiated a 4% survival benefit and, for stage II and III, more than 90% probability of a 6% benefit and 50% probability of a 12% benefit.ConclusionWhen evaluated in context with prior data, IALT did not support a 4% survival benefit. However, sequential updating with JBR.10 and ANITA did. A model for future assessments, this study demonstrates the unique ability of Bayesian analysis to evaluate results that contradict prior evidence.
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Petersen, Johanne Juul, Caroline Barkholt Kamp, Pascal Faltermeier, et al. "Deep brain stimulation for Parkinson’s disease: systematic review with meta-analysis and trial sequential analysis." BMJ Medicine 3, no. 1 (2024): e000705. http://dx.doi.org/10.1136/bmjmed-2023-000705.
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ObjectiveTo assess the benefits and harms of deep brain stimulation for Parkinson’s disease.DesignSystematic review with meta-analysis and trial sequential analysis.Data sourcesCochrane Central Register of Controlled Trials (CENTRAL), Medline, Embase, Latin American and Caribbean Health Sciences Literature (LILACS), and other sources, from inception to 9 May 2023.Eligibility criteria for selecting studiesRandomised clinical trials of deep brain stimulation with antiparkinsonian drug treatment use versus antiparkinsonian drugs only (primary comparison, seven trials) for Parkinson’s disease. Other comparisons were deep brain stimulation versus surgery with sham stimulation (three trials) and versus resective surgery (two trials).ResultsPrimary outcomes were all cause mortality, serious adverse events, and disease specific symptoms. In seven trials, 1125 participants were randomised to receive deep brain stimulation with antiparkinsonian drugs versus antiparkinsonian drugs only. All results had a high risk of bias and the certainty of the evidence was very low for all primary outcomes. Information size was insufficient for assessing all cause mortality (risk ratio 2.69, 95% confidence interval (CI) 0.79 to 9.24; I2=0.0%; τ2=0.00; P=0.12; four trials). Meta-analysis showed that deep brain stimulation increased the risk of serious adverse events (risk ratio 2.36, 95% CI 1.37 to 4.09; I2=73.7%; τ2=0.24; P<0.01; six trials) mainly because of an increased risk of perioperative complications, such as cerebral haemorrhages and postoperative confusion, and hardware related events, such as infection at the stimulator site, dislocation of the device, or reoperations. Meta-analyses indicated that deep brain stimulation might reduce some symptoms specific to Parkinson's disease, but assessment of disease specific symptoms in these trials had methodological limitations, including not reporting overall symptom scores.ConclusionsThe certainty of evidence was very low for all primary outcomes, and based on the included evidence, the beneficial effects were questionable because of methodological limitations. Compared with only antiparkinsonian drug treatment, deep brain stimulation with antiparkinsonian drugs seemed to increase the risk of serious adverse events, mainly because of perioperative complications and hardware related events. Conducting randomised clinical trials of adequate methodological quality to effectively evaluate the effects of deep brain stimulation is crucial.Systematic review registrationPROSPERO CRD42022306556.
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Jakobsen, J. C., J. L. Hansen, S. Simonsen, E. Simonsen, and C. Gluud. "Effects of cognitive therapy versus interpersonal psychotherapy in patients with major depressive disorder: a systematic review of randomized clinical trials with meta-analyses and trial sequential analyses." Psychological Medicine 42, no. 7 (2011): 1343–57. http://dx.doi.org/10.1017/s0033291711002236.
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BackgroundMajor depressive disorder afflicts an estimated 17% of individuals during their lifetime at tremendous suffering and cost. Cognitive therapy and interpersonal psychotherapy are treatment options, but their effects have only been limitedly compared in systematic reviews.MethodUsing Cochrane systematic review methodology we compared the benefits and harm of cognitive therapy versus interpersonal psychotherapy for major depressive disorder. Trials were identified by searching the Cochrane Library's CENTRAL, Medline via PubMed, EMBASE, Psychlit, PsycInfo, and Science Citation Index Expanded until February 2010. Continuous outcome measures were assessed by mean difference and dichotomous outcomes by odds ratio. We conducted trial sequential analysis to control for random errors.ResultsWe included seven trials randomizing 741 participants. All trials had high risk of bias. Meta-analysis of the four trials reporting data at cessation of treatment on the Hamilton Rating Scale for Depression showed no significant difference between the two interventions [mean difference −1.02, 95% confidence interval (CI) −2.35 to 0.32]. Meta-analysis of the five trials reporting data at cessation of treatment on the Beck Depression Inventory showed comparable results (mean difference −1.29, 95% CI −2.73 to 0.14). Trial sequential analysis indicated that more data are needed to definitively settle the question of a differential effect. None of the included trial reported on adverse events.ConclusionsRandomized trials with low risk of bias and low risk of random errors are needed, although the effects of cognitive therapy and interpersonal psychotherapy do not seem to differ significantly regarding depressive symptoms. Future trials should report on adverse events.
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Seewald, Nicholas J., Kelley M. Kidwell, Inbal Nahum-Shani, Tianshuang Wu, James R. McKay, and Daniel Almirall. "Sample size considerations for comparing dynamic treatment regimens in a sequential multiple-assignment randomized trial with a continuous longitudinal outcome." Statistical Methods in Medical Research 29, no. 7 (2019): 1891–912. http://dx.doi.org/10.1177/0962280219877520.
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Clinicians and researchers alike are increasingly interested in how best to personalize interventions. A dynamic treatment regimen is a sequence of prespecified decision rules which can be used to guide the delivery of a sequence of treatments or interventions that is tailored to the changing needs of the individual. The sequential multiple-assignment randomized trial is a research tool which allows for the construction of effective dynamic treatment regimens. We derive easy-to-use formulae for computing the total sample size for three common two-stage sequential multiple-assignment randomized trial designs in which the primary aim is to compare mean end-of-study outcomes for two embedded dynamic treatment regimens which recommend different first-stage treatments. The formulae are derived in the context of a regression model which leverages information from a longitudinal outcome collected over the entire study. We show that the sample size formula for a sequential multiple-assignment randomized trial can be written as the product of the sample size formula for a standard two-arm randomized trial, a deflation factor that accounts for the increased statistical efficiency resulting from a longitudinal analysis, and an inflation factor that accounts for the design of a sequential multiple-assignment randomized trial. The sequential multiple-assignment randomized trial design inflation factor is typically a function of the anticipated probability of response to first-stage treatment. We review modeling and estimation for dynamic treatment regimen effect analyses using a longitudinal outcome from a sequential multiple-assignment randomized trial, as well as the estimation of standard errors. We also present estimators for the covariance matrix for a variety of common working correlation structures. Methods are motivated using the ENGAGE study, a sequential multiple-assignment randomized trial aimed at developing a dynamic treatment regimen for increasing motivation to attend treatments among alcohol- and cocaine-dependent patients.
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Luís, Ângelo, Fernanda Domingues, and Luísa Pereira. "Association between berries intake and cardiovascular diseases risk factors: a systematic review with meta-analysis and trial sequential analysis of randomized controlled trials." Food & Function 9, no. 2 (2018): 740–57. http://dx.doi.org/10.1039/c7fo01551h.
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The main goal of this work was to clarify the effects of the consumption of berries on cardiovascular disease (CVD) risk factors by performing a systematic review followed by a meta-analysis and a trial sequential analysis (TSA).
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Schwendicke, Falk, Gerd Göstemeyer, and Christian Gluud. "Cavity lining after excavating caries lesions: Meta-analysis and trial sequential analysis of randomized clinical trials." Journal of Dentistry 43, no. 11 (2015): 1291–97. http://dx.doi.org/10.1016/j.jdent.2015.07.017.
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Sillassen, Christina Dam Bjerregaard, Caroline Barkholt Kamp, Johanne Juul Petersen, et al. "Adverse effects with semaglutide: a protocol for a systematic review with meta-analysis and trial sequential analysis." BMJ Open 14, no. 6 (2024): e084190. http://dx.doi.org/10.1136/bmjopen-2024-084190.
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IntroductionSemaglutide is increasingly used for the treatment of type 2 diabetes mellitus, overweight and other conditions. It is well known that semaglutide lowers blood glucose levels and leads to significant weight loss. Still, a systematic review has yet to investigate the adverse effects with semaglutide for all patient groups.Methods and analysisWe will conduct a systematic review and search major medical databases (Cochrane Central Register of Controlled Trials, Medline, Embase, Latin American and Caribbean Health Sciences Literature, Science Citation Index Expanded, Conference Proceedings Citation Index—Science) and clinical trial registries from their inception and onwards to identify relevant randomised clinical trials. We expect to conduct the literature search in July 2024. Two review authors will independently extract data and perform risk-of-bias assessments. We will include randomised clinical trials comparing oral or subcutaneous semaglutide versus placebo. Primary outcomes will be all-cause mortality and serious adverse events. Secondary outcomes will be myocardial infarction, stroke, all-cause hospitalisation and non-serious adverse events. Data will be synthesised by meta-analyses and trial sequential analysis; risk of bias will be assessed with Cochrane Risk of Bias tool—version 2, an eight-step procedure will be used to assess if the thresholds for statistical and clinical significance are crossed, and the certainty of the evidence will be assessed by Grading of Recommendations, Assessment, Development and Evaluations.Ethics and disseminationThis protocol does not present any results. Findings of this systematic review will be published in international peer-reviewed scientific journals.PROSPERO registration numberCRD42024499511.
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