A simple formula for enumerating comparisons in trials and network meta-analysis.
Ontology highlight
ABSTRACT:
SUBMITTER: Shokraneh F
PROVIDER: S-EPMC6402080 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Network meta-analysis (NMA) expands the scope of a conventional pairwise meta-analysis to simultaneously handle multiple treatment comparisons. However, some trials may appear to deviate markedly from the others and thus be inappropriate to be synthesized in the NMA. In addition, the inclusion of these trials in evidence synthesis may lead to bias in estimation. We call such trials trial-level outliers. To the best of our knowledge, while heterogeneity and inconsistency in NMA have been extensively discussed and well addressed, few previous papers have considered the proper detection and handling of trial-level outliers. In this paper, we propose several Bayesian outlier detection measures, which are then applied to a diabetes data set. Simulation studies comparing our approaches in both arm-based and contrast-based model settings are provided in two supporting appendices.
| S-EPMC4496319 | biostudies-literature
Project description:PURPOSE:We propose a new method to calculate proptosis by using the simple Heron's formula and analyze its feasibility. METHOD:It was a none-inferiority trial. The registration number was ChiCTR1900026490. The absolute value of proptosis in 120 eyes, 60 patients without eye injury or diseases, was measured by computed tomography (CT) and simple Heron's formula. We did regression analysis and analyzed the differences between the two methods with Medcalc software version 19.0.4. The result was showed by Passing-Bablok regression analysis diagram and Bland and Altman plot. RESULTS:The Passing-Bablok showed that the result of proptosis measured by CT and simple Heron's formula showed good positive correlation. A 95% limit of agreement in proptosis between CT and Heron's formula method was -0.46 to 0.54 mm in right eye and -0.45 to 0.46 mm in left eye. 1.66% (1/60) point was outside 95% LoA in both eyes. Moreover, a 95% limit of agreement between CT and Heron's formula method was -0.42 to 0.56 mm in difference of both eyes. 3.33% (2/60) points were outside 95% LoA. The points in all Bland and Altman plots were lower than 5%. It means that the results of comparison between the two methods had a good consistency in the measurement of proptosis. CONCLUSIONS:Heron's formula could be applied to calculate proptosis and has a good consistency compared with computed tomography (CT). This method is practical in proptosis assessment because of its accuracy, reliability and simplicity.
| S-EPMC7263846 | biostudies-literature
Project description:Several kinds of inotropes have been used in critically ill patients to improve hemodynamics and renal dysfunction after cardiac surgery; however, the treatment strategies for reducing mortality and increasing renal protection in patients who underwent cardiac surgery remain controversial. Therefore, we performed a comprehensive network meta-analysis to overcome the lack of head-to-head comparisons. A systematic database was searched up to 31 December 2020, for randomized controlled trials that compared different inotropes on mortality outcomes and renal protective effects after cardiac surgery. A total of 29 trials were included and a frequentist network meta-analysis was performed. Inconsistency analyses, publication bias, and subgroup analyses were also conducted. Compared with placebo, use of levosimendan significantly decreased the risks of mortality (odds ratio (OR): 0.74; 95% confidence interval (CI): 0.56-0.97) and risk of acute renal injury (OR: 0.61; 95% CI: 0.45-0.82), especially in low systolic function patients. Use of levosimendan also ranked the best treatment based on the P-score (90.1%), followed by placebo (64.5%), milrinone (49.6%), dopamine (49.5%), dobutamine (29.1%), and fenoldopam (17.0%). Taking all the available data into consideration, levosimendan was a safe renal-protective choice for the treatment of patients undergoing cardiac surgery, especially for those with low systolic function.
| S-EPMC7959132 | biostudies-literature
Project description:In the absence of sufficient data directly comparing multiple treatments, indirect comparisons using network meta-analyses (NMAs) can provide useful information. Under current contrast-based (CB) methods for binary outcomes, the patient-centered measures including the treatment-specific event rates and risk differences (RDs) are not provided, which may create some unnecessary obstacles for patients to comprehensively trade-off efficacy and safety measures.We aim to develop NMA to accurately estimate the treatment-specific event rates.A Bayesian hierarchical model is developed to illustrate how treatment-specific event rates, RDs, and risk ratios (RRs) can be estimated. We first compare our approach to alternative methods using two hypothetical NMAs assuming a fixed RR or RD, and then use two published NMAs to illustrate the improved reporting.In the hypothetical NMAs, our approach outperforms current CB NMA methods in terms of bias. In the two published NMAs, noticeable differences are observed in the magnitude of relative treatment effects and several pairwise statistical significance tests from previous report.First, to facilitate the estimation, each study is assumed to hypothetically compare all treatments, with unstudied arms being missing at random. It is plausible that investigators may have selected treatment arms on purpose based on the results of previous trials, which may lead to 'nonignorable missingness' and potentially bias our estimates. Second, we have not considered methods to identify and account for potential inconsistency between direct and indirect comparisons.The proposed NMA method can accurately estimate treatment-specific event rates, RDs, and RRs and is recommended.
| S-EPMC3972291 | biostudies-literature
Project description:BackgroundNetwork meta-analysis (NMA), a generalization of conventional MA, allows for assessing the relative effectiveness of multiple interventions. Reporting bias is a major threat to the validity of MA and NMA. Numerous methods are available to assess the robustness of MA results to reporting bias. We aimed to extend such methods to NMA.MethodsWe introduced 2 adjustment models for Bayesian NMA. First, we extended a meta-regression model that allows the effect size to depend on its standard error. Second, we used a selection model that estimates the propensity of trial results being published and in which trials with lower propensity are weighted up in the NMA model. Both models rely on the assumption that biases are exchangeable across the network. We applied the models to 2 networks of placebo-controlled trials of 12 antidepressants, with 74 trials in the US Food and Drug Administration (FDA) database but only 51 with published results. NMA and adjustment models were used to estimate the effects of the 12 drugs relative to placebo, the 66 effect sizes for all possible pair-wise comparisons between drugs, probabilities of being the best drug and ranking of drugs. We compared the results from the 2 adjustment models applied to published data and NMAs of published data and NMAs of FDA data, considered as representing the totality of the data.ResultsBoth adjustment models showed reduced estimated effects for the 12 drugs relative to the placebo as compared with NMA of published data. Pair-wise effect sizes between drugs, probabilities of being the best drug and ranking of drugs were modified. Estimated drug effects relative to the placebo from both adjustment models were corrected (i.e., similar to those from NMA of FDA data) for some drugs but not others, which resulted in differences in pair-wise effect sizes between drugs and ranking.ConclusionsIn this case study, adjustment models showed that NMA of published data was not robust to reporting bias and provided estimates closer to that of NMA of FDA data, although not optimal. The validity of such methods depends on the number of trials in the network and the assumption that conventional MAs in the network share a common mean bias mechanism.
| S-EPMC3537713 | biostudies-literature
Project description:Drug development struggles with high costs and time consuming processes. Hence, a need for new strategies has been accentuated by many stakeholders in drug development. This study proposes the use of pharmacometric models to rationalize drug development. Two simulated examples, within the therapeutic areas of acute stroke and type 2 diabetes, are utilized to compare a pharmacometric model-based analysis to a t-test with respect to study power of proof-of-concept (POC) trials. In all investigated examples and scenarios, the conventional statistical analysis resulted in several fold larger study sizes to achieve 80% power. For a scenario with a parallel design of one placebo group and one active dose arm, the difference between the conventional and pharmacometric approach was 4.3- and 8.4-fold, for the stroke and diabetes example, respectively. Although the model-based power depend on the model assumptions, in these scenarios, the pharmacometric model-based approach was demonstrated to permit drastic streamlining of POC trials.CPT: Pharmacometrics & Systems Pharmacology (2013) 2, e23; doi:10.1038/psp.2012.24; advance online publication 16 January 2013.
| S-EPMC3600728 | biostudies-literature
Project description:Hypertension is a major cardiovascular risk factor, which seriously affects the quality of life of patients. Banxia Baizhu Tianma Decoction (BXD) is a Chinese herbal formula that is widely used to treat hypertension in China. This study aimed to evaluate the efficacy and potential mechanism of BXD for hypertension by meta-analysis and network pharmacology. Meta-analysis was performed to explore the efficacy and safety of BXD combined with conventional treatment for hypertension. Network pharmacology was used to explore the molecular mechanism of BXD in antihypertension. A total of 23 studies involving 2,041 patients were included. Meta-analysis indicated that compared with conventional treatment, combined BXD treatment was beneficial to improve clinical efficacy rate, blood pressure, blood lipids, homocysteine, endothelial function, inflammation, and traditional Chinese medicine symptom score. In addition, meta-analysis indicated that BXD is safe and has no obvious adverse reactions. Network pharmacology showed that the antihypertensive targets of BXD may be AKT1, NOS3, ACE, and PPARG. The antihypertensive active ingredients of BXD may be naringenin, poricoic acid C, eburicoic acid, and licochalcone B. Due to the poor methodological quality of the Chinese studies and the small sample size of most, the analysis of this study may have been affected by bias. Therefore, the efficacy and safety of BXD for hypertension still need to be further verified by high-quality clinical studies. Systematic Review Registration: https://www.crd.york.ac.uk/prospero/, identifier CRD42022353666.
| S-EPMC9755740 | biostudies-literature
Project description:Ankylosing spondylitis (AS) is an inflammatory rheumatic disease with impact on axial skeleton, peripheral joints and enthuses, and it may result in severe disabilities of those parts. Tumor necrosis factor-? (TNF-?) inhibitors are considered as an effective treatment for patients with active AS. In this study, we conducted a network meta-analysis to compare the clinical outcomes of active AS patients treated with TNF-? inhibitors. Randomized controlled trials (RCTs) evaluating the efficacy and safety of TNF-? inhibitors were retrieved in literature search and selected for meta-analysis. Changes in ASAS20 response, ASAS40 response and BASDAI 50% response were regarded as efficacy outcomes; serious adverse events (SAE) and all cause withdrawals were regarded as safety outcomes. Both traditional pairwise meta-analysis and network meta-analysis were performed. The results showed that adalimumab and infliximab had better clinical outcomes. Infliximab consistently appeared to be the most effective TNF-? inhibitors with a high risk of adverse events for patients with active AS; meanwhile, adalimumab ranked highest with respect to adverse effects with efficacy secondary to infliximab. As a result, we were unable to conclude the optimal TNF-? inhibitor and this issue should be solved by future researchers.
| S-EPMC5036083 | biostudies-other
Project description:BackgroundCervical cancer is a common malignancy of the female genital tract. Treatment options for cervical cancer patients diagnosed at FIGO (2009) stage IB2 and IIA2 remains controversial.MethodsWe perform a Bayesian network meta-analysis to directly or indirectly compare various interventions for FIGO (2009) IB2 and IIA2 disease, in order to improve our understand of the optimal treatment strategy for these women. Three databases were searched for articles published between 1971 and 2020. Data on included study characteristics, outcomes, and risk of bias were abstracted by two reviewers.ResultsSeven thousand four hundred eighty-six articles were identified. Thirteen randomized controlled trials of FIGO (2009) IB2 and IIA2 cervical cancer patients were included in the final analysis. These trials used six different interventions: concomitant chemoradiotherapy (CCRT), radical surgery (RS), radical surgery following chemoradiotherapy (CCRT+RS), neoadjuvant chemotherapy followed by radical surgery (NACT+RS), adjuvant radiotherapy followed by Radical surgery (RT + RS), radiotherapy alone (RT).SUCRA ranking of OS and Relapse identified CCRT+RS and CCRT as the best interventions, respectively. Systematic clustering analysis identified the CCRT group as a unique cluster.ConclusionThese data suggest that CCRT may be the best approach for improving the clinical outcome of cervical cancer patients diagnosed at FIGO (2009) stage IB2/IIA2. Phase III randomized trials should be performed in order to robustly assess the relative efficacy of available treatment strategies in this disease context.
| S-EPMC8493709 | biostudies-literature
Project description:ObjectiveTo compare the effectiveness of various drug interventions in improving the clinical outcome of postoperative patients after aneurysmal subarachnoid hemorrhage (aSAH) and assist in determining the drugs of definite curative effect in improving clinical prognosis.MethodsEligible Randomized Controlled Trials (RCTs) were searched in databases of PubMed, EMBASE, and Cochrane Library (inception to Sep 2020). Glasgow Outcome Scale (GOS) score, Extended Glasgow Outcome Scale (GOSE) score or modified Rankin Scale (mRS) score was used as the main outcome measurements to evaluate the efficacy of various drugs in improving the clinical outcomes of postoperative patients with aSAH. The network meta-analysis (NMA) was conducted based on a random-effects model, dichotomous variables were determined by using odds ratio (OR) with 95% confidence interval (CI), and a surface under the cumulative ranking curve (SUCRA) was generated to estimate the ranking probability of comparative effectiveness among different drug therapies.ResultsFrom the 493 of initial citation screening, forty-four RCTs (n = 10,626 participants) were eventually included in our analysis. Our NMA results showed that cilostazol (OR = 3.35,95%CI = 1.50,7.51) was the best intervention to improve the clinical outcome of patients (SUCRA = 87.29%, 95%CrI 0.07-0.46). Compared with the placebo group, only two drug interventions [nimodipine (OR = 1.61, 95%CI 1.01,2.57) and cilostazol (OR = 3.35, 95%CI 1.50, 7.51)] achieved significant statistical significance in improving the clinical outcome of patients.ConclusionsBoth nimodipine and cilostazol have exact curative effect to improve the outcome of postoperative patients with aSAH, and cilostazol may be the best drug to improve the outcome of patients after aSAH operation. Our study provides implications for future studies that, the combination of two or more drugs with relative safety and potential benefits (e.g., nimodipine and cilostazol) may improve the clinical outcome of patients more effectively.
| S-EPMC8314452 | biostudies-literature