scholarly journals BJS.03Markov Decision Analysis of Treatment Pathways for Resectable Malignancy of the Oesophagus or Gastrooesophageal Junction

2021 ◽  
Vol 108 (Supplement_7) ◽  
Author(s):  
Alison Bradley ◽  
Leo Brown
Keyword(s):  
Sensitivity Analysis ◽  
Overall Survival ◽  
Monte Carlo ◽  
Decision Analysis ◽  
Randomised Controlled Trials ◽  
Gastroesophageal Junction ◽  
Neoadjuvant Chemoradiotherapy ◽  
Controlled Trials ◽  
Treatment Pathways ◽  
Randomised Controlled

Abstract Aims To perform decision-analysis of treatment options for resectable malignancy of the oesophagus or gastroesophageal junction including: surgery alone, neoadjuvant chemoradiotherapy, neoadjuvant chemotherapy and surgery followed by adjuvant therapy based on current highest-level evidence. Methods A Markov decision analysis model in an advanced decision-tree format was constructedand populated with data from existing randomised controlled trials. Markov model transition probabilities were based on weighted pooled estimates of proportions from included studies, calculated using Freeman-Tukey arcsine square root transformation under random effects model to account for heterogeneity.Each Markov cycle equated with one month and Markov states within the model included: alive without disease, alive with disease and dead. Extensive deterministic and Monte Carlo probabilistic sensitivity analysis was performed to test all parameters contained within the model. Results 23 randomised controlled trials were included. Intention-to-treat analysis of the treatment pathways showed that neoadjuvant chemoradiotherapy was the superior pathway with an overall survival time of 50.52 months (42.26 QALMs). Monte Carlo sensitivity analysis run over 10000 iterations showed that neoadjuvant chemoradiotherapy was selected as the superior treatment pathway at a frequency of 93.21% followed by surgery followed by adjuvant therapy with a frequency of 6.79%. Subgroup analysis of only squamous cell carcinomas demonstrated that neoadjuvant chemoradiotherapy was the superior pathway with an overall survival time of 62.67 months (55.22 QALMs). Conclusions Based on current best available evidence this decision analysis supports neoadjuvant chemoradiotherapy as the treatment strategy of choice for resectable malignancy of the oesophagus or gastroesophageal junction.

scholarly journals Surrogate endpoints for overall survival in randomised controlled trials of localised osteosarcoma: A meta-analytic evaluation

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Kazuhiro Tanaka ◽  
Masanori Kawano ◽  
Tatsuya Iwasaki ◽  
Shogo Matsuda ◽  
Ichiro Itonaga ◽  
...  
Keyword(s):  
Overall Survival ◽  
Randomised Controlled Trials ◽  
Surrogate Endpoints ◽  
Controlled Trials ◽  
Analytic Evaluation ◽  
Randomised Controlled

scholarly journals Iron deficiency without anaemia is a potential cause of fatigue: meta-analyses of randomised controlled trials and cross-sectional studies

2017 ◽  
Vol 117 (10) ◽  
pp. 1422-1431 ◽  
Author(s):  
Katsuhiko Yokoi ◽  
Aki Konomi
Keyword(s):  
Sensitivity Analysis ◽  
Therapeutic Effect ◽  
Effect Size ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Cross Sectional ◽  
Cross Sectional Studies ◽  
Randomised Controlled ◽  
Meta Analyses

AbstractFe deficiency is a prevalent nutritional disease, and fatigue is a common complaint in the general and patient population. The association between Fe deficiency without anaemia (IDNA) and fatigue is unclear. Here, we performed a meta-analysis to evaluate the therapeutic effect of Fe on fatigue in patients with IDNA and the association between IDNA and fatigue in the population. Articles from the PubMed database up to 19 January 2016 were systematically searched. A total of six relevant randomised controlled trials (RCT) and six relevant cross-sectional studies were identified. All outcomes were converted into effect sizes. In the meta-analysis of the six RCT, we identified a significant therapeutic effect of Fe in fatigue patients with IDNA (pooled effect size 0·33; 95 % CI 0·17, 0·48;I2=0·0 %;P<0·0001). A sensitivity analysis found that the overall results (i.e. significant association) were robust. In the meta-analysis of the six cross-sectional studies, the association between IDNA and fatigue was not significant (pooled effect size 0·10; 95 % CI −0·11, 0·31;I2=57·4 %;P=0·362). A sensitivity analysis found that the overall results (i.e. no significant association) were not robust; removal of one study made the outcomes significant. These meta-analyses suggest that improving Fe status may decrease fatigue. Further research is necessary to identify diagnostic criteria for selecting fatigue patients who might benefit from Fe therapy and to assess the prevalence of IDNA with fatigue in the general population.

scholarly journals A review of the use of controlled multiple imputation in randomised controlled trials with missing outcome data

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Ping-Tee Tan ◽  
Suzie Cro ◽  
Eleanor Van Vogt ◽  
Matyas Szigeti ◽  
Victoria R. Cornelius
Keyword(s):  
Sensitivity Analysis ◽  
Missing Data ◽  
Multiple Imputation ◽  
Randomised Controlled Trials ◽  
Missing At Random ◽  
Sensitivity Analyses ◽  
Controlled Trials ◽  
Primary Analysis ◽  
Randomised Controlled ◽  
The Impact

Abstract Background Missing data are common in randomised controlled trials (RCTs) and can bias results if not handled appropriately. A statistically valid analysis under the primary missing-data assumptions should be conducted, followed by sensitivity analysis under alternative justified assumptions to assess the robustness of results. Controlled Multiple Imputation (MI) procedures, including delta-based and reference-based approaches, have been developed for analysis under missing-not-at-random assumptions. However, it is unclear how often these methods are used, how they are reported, and what their impact is on trial results. This review evaluates the current use and reporting of MI and controlled MI in RCTs. Methods A targeted review of phase II-IV RCTs (non-cluster randomised) published in two leading general medical journals (The Lancet and New England Journal of Medicine) between January 2014 and December 2019 using MI. Data was extracted on imputation methods, analysis status, and reporting of results. Results of primary and sensitivity analyses for trials using controlled MI analyses were compared. Results A total of 118 RCTs (9% of published RCTs) used some form of MI. MI under missing-at-random was used in 110 trials; this was for primary analysis in 43/118 (36%), and in sensitivity analysis for 70/118 (59%) (3 used in both). Sixteen studies performed controlled MI (1.3% of published RCTs), either with a delta-based (n = 9) or reference-based approach (n = 7). Controlled MI was mostly used in sensitivity analysis (n = 14/16). Two trials used controlled MI for primary analysis, including one reporting no sensitivity analysis whilst the other reported similar results without imputation. Of the 14 trials using controlled MI in sensitivity analysis, 12 yielded comparable results to the primary analysis whereas 2 demonstrated contradicting results. Only 5/110 (5%) trials using missing-at-random MI and 5/16 (31%) trials using controlled MI reported complete details on MI methods. Conclusions Controlled MI enabled the impact of accessible contextually relevant missing data assumptions to be examined on trial results. The use of controlled MI is increasing but is still infrequent and poorly reported where used. There is a need for improved reporting on the implementation of MI analyses and choice of controlled MI parameters.

Intraocular bleeding in patients managed with novel oral anticoagulation and traditional anticoagulation: a network meta-analysis and systematic review

2018 ◽  
Vol 103 (5) ◽  
pp. 641-647 ◽  
Author(s):  
Kevin Phan ◽  
Declan Lloyd ◽  
Ash Wilson-Smith ◽  
Vannessa Leung ◽  
Marko Andric
Keyword(s):  
Monte Carlo ◽  
Markov Chain ◽  
Markov Chain Monte Carlo ◽  
Randomised Controlled Trials ◽  
Rare Event ◽  
Future Research ◽  
Controlled Trials ◽  
Randomised Controlled ◽  
The Relationship ◽  
Intraocular Bleeding

Background/aimTo clarify the nature of the relationship between novel oral anticoagulants (NOACs) and traditional anticoagulation in respect to intraocular bleeding.MethodsA comprehensive literature search up to October 2017 yielded 12 randomised controlled trials. Bayesian Markov chain Monte Carlo analysis was employed to investigate the relationship across multiple trials with varying NOACs. Random effects (informative priors) ORs were applied for the risk of intraocular bleeding due to various treatment measures. Mantel-Haenszel pairwise analyses were also performed. A total of 102 617 participants from 12 different randomised controlled trials. 11 746 received apixaban, 16 074 received dabigatran, 18 132 received edoxaban, 11 893 received rivaroxaban and 44 764 received warfarin.ResultsEdoxaban was significantly associated with a reduced risk of intraocular bleeding in comparison to warfarin (OR 0.59; 95% CI 0.34 to 0.98). All other findings were non-significant; however, apixaban was the only NOAC to trend with an increased event rate against warfarin. The Bayesian Markov chain Monte Carlo modelling indicated that edoxaban had the greatest chance of producing the lowest rate of bleeding (surface under the cumulative ranking curve 0.8642). Pooled pairwise analysis supported the network analysis results favouring edoxaban against warfarin (OR 0.59; 95% CI 0.39 to 0.90; p=0.02) as well as subgroup analysis of low-dose edoxaban versus warfarin (OR 0.43; 95% CI 0.24 to 0.78).ConclusionThe analysis suggests that edoxaban may be the paramount agent in reducing intraocular bleeding rates. Given a paucity of reporting data for this rare event, future research and confirmation is strongly recommended.

scholarly journals Surrogate endpoints for overall survival in metastatic melanoma: a meta-analysis of randomised controlled trials

2014 ◽  
Vol 15 (3) ◽  
pp. 297-304 ◽  
Author(s):  
Keith T Flaherty ◽  
Michael Hennig ◽  
Sandra J Lee ◽  
Paolo A Ascierto ◽  
Reinhard Dummer ◽  
...  
Keyword(s):  
Overall Survival ◽  
Metastatic Melanoma ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Surrogate Endpoints ◽  
Controlled Trials ◽  
Randomised Controlled
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