Optimal information size in trial sequential analysis of time-to-event outcomes reveals potentially inconclusive results because of the risk of random error

Miladinović, Branko; Mhaskar, Rahul; Hozo, Iztok; Kumar, Amit; Mahony, Helen; Djulbegoviĉ, Benjamin

doi:10.1016/j.jclinepi.2012.11.007

Cited by 27 publications

(20 citation statements)

References 39 publications

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“…We conducted meta‐regression analysis to investigate the association of gauge of cutting and pencil SNs and incidence of PDPH separately using OpenMetaAnalyst software program. To assess the power of our meta‐analysis, we conducted the trial sequential analysis (TSA) using program metacumbounds employing the O'Brian‐Fleming spending function and random pooling method in statistical software Stata . Specifically, we calculated the power of our meta‐analysis based on prespecified relative risk reduction (RRR) estimates and the total number of patients (actual information size) in our meta‐analysis.…”

Section: Methodsmentioning

confidence: 99%

Impact of spinal needle type on postdural puncture headache among women undergoing Cesarean section surgery under spinal anesthesia: A meta‐analysis

Lee

Sandhu

Djulbegoviĉ³

et al. 2018

J Evidence Based Medicine

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Section: Methodsmentioning

confidence: 99%

Impact of spinal needle type on postdural puncture headache among women undergoing Cesarean section surgery under spinal anesthesia: A meta‐analysis

Lee

Sandhu

Djulbegoviĉ³

et al. 2018

J Evidence Based Medicine

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“…Publication bias was evaluated using funnel plots and Begg’s test ( Begg and Berlin, 1989 ; Begg and Mazumdar, 1994 ). TSA was performed for overall and subgroup meta-analyses to determine whether enough information accumulated for a definitive conclusion ( Miladinovic et al, 2013 ). The a priori diversity-adjusted information size (APDIS) was used as the information measurement.…”

Section: Methodsmentioning

confidence: 99%

“…The prespecified type I error was set as two-sided α = 0.05, and type II error as β = 20% (1 - β = 80% power). A conservative relative risk reduction (RRR) of 15% was used as described previously ( Miladinovic et al, 2013 ). O’Brian-Fleming boundaries were used ( DeMets and Lan, 1994 ).…”

Section: Methodsmentioning

confidence: 99%

Long-Term Efficacy of Maintenance Therapy for Multiple Myeloma: A Quantitative Synthesis of 22 Randomized Controlled Trials

Guang-yu

Liu

et al. 2018

Front. Pharmacol.

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We aimed to quantitatively synthesize data from randomized controlled trials (RCTs) concerning maintenance for multiple myeloma (MM). We searched electronic literature databases and conference proceedings to identify relevant RCTs. We selected eligible RCTs using predefined selection criteria. We conducted meta-analysis comparing maintenance containing new agents and conventional maintenance, and subgroup analysis by transplantation status and mainstay agent as well. We performed trial sequential analysis (TSA) to determine adequacy of sample size for overall and subgroup meta-analyses. We performed network meta-analysis (NMA) to compare and rank included regimens. A total of 22 RCTs involving 9,968 MM patients and 15 regimens were included, the overall quality of which was adequate. Significant heterogeneity was detected for progression-free survival (PFS) but not overall survival (OS). Meta-analyses showed that maintenance containing new agents significantly improved PFS but not OS [PFS: Hazard Ratio (HR) = 0.59, 95% Confidence Interval (CI) = 0.54 to 0.64; OS: HR = 0.93, 95% CI = 0.87 to 1.00], compared with controls. Subgroup analyses revealed lenalidomide (Len)-based therapies better than thalidomide-based ones (HR = 0.50 and 0.66, respectively; P = 0.001). NMA revealed that most of the maintenance regimens containing new agents were significantly better than simple observation in terms of PFS but not OS. Len single agent was the most effective, considering PFS and OS both. We concluded that conventional maintenance has very limited effect. Maintenance containing new agents is highly effective in improving PFS, but has very limited effect on OS. Maintenance with Len may have the largest survival benefits. Emerging strategies may further change the landscape of maintenance of MM.

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“…To correct for random errors and repetitive testing, which are possibly produced in the conventional meta-analysis, and to assess whether the current evidence is conclusive, we will therefore perform trial sequential analysis. 44 45 We will conduct cumulative meta-analyses and trial sequential analyses by publication year and sample size. To determine whether the effect of bisphosphonates will disappear, persist, attenuate or be more pronounced with the time of follow-up, we will conduct subgroup analyses, cumulative meta-analyses and trial sequential analyses according to the follow-up periods, using all the data sets reported after different follow-up periods from the same trials.…”

Section: Methodsmentioning

confidence: 99%

Bisphosphonate and risk of cancer recurrence: protocol for a systematic review, meta-analysis and trial sequential analysis of randomised controlled trials

Liu

Zhang

et al. 2015

BMJ Open

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IntroductionNo consensus exists on the associations between adjuvant treatment with bisphosphonates and cancer recurrence risk among patients with primary early-stage cancers. We plan to perform a comprehensive systematic review, study-level meta-analysis and trial sequential analysis of randomised controlled trials to comprehensively summarise evidence of the bisphosphonate treatment for difference cancers.Methods and analysesWe will report our results according to the PRISMA guideline. The primary outcomes include any cancer recurrence and bone metastasis and secondary outcomes include events of local recurrence, regional recurrence or non-skeletal distant metastasis, disease-free survival and overall survival. We will perform systematic electronic searches and other manual searches. To be conservative, all statistical analyses will be conducted with random-effects models. Cumulative meta-analyses and trial sequential analyses will be performed to assess whether and when firm evidence is reached. Various sensitivity analyses and rigid publication bias analyses will be performed to challenge the consistency and robustness of results. We will also grade the quality of evidence with the GRADE system.Ethics and disseminationEthical approval is not required in this study. The findings will be submitted for publication in a peer-reviewed journal and also presented at relevant national and international conferences.Trial registration numberPROSPERO CRD42014014699.

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Optimal information size in trial sequential analysis of time-to-event outcomes reveals potentially inconclusive results because of the risk of random error

Cited by 27 publications

References 39 publications

Impact of spinal needle type on postdural puncture headache among women undergoing Cesarean section surgery under spinal anesthesia: A meta‐analysis

Impact of spinal needle type on postdural puncture headache among women undergoing Cesarean section surgery under spinal anesthesia: A meta‐analysis

Long-Term Efficacy of Maintenance Therapy for Multiple Myeloma: A Quantitative Synthesis of 22 Randomized Controlled Trials

Bisphosphonate and risk of cancer recurrence: protocol for a systematic review, meta-analysis and trial sequential analysis of randomised controlled trials

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