A sensitivity analysis for subverting randomization in controlled trials

2001 ◽  
Vol 20 (4) ◽  
pp. 545-555 ◽  
Author(s):  
Sue M. Marcus
Keyword(s):  
Sensitivity Analysis ◽  
Controlled Trials

scholarly journals Conservative oxygen therapy for critically ill patients: a meta-analysis of randomized controlled trials

2021 ◽  
Vol 9 (1) ◽  
Author(s):  
Xiao-Li Chen ◽  
Bei-Lei Zhang ◽  
Chang Meng ◽  
Hui-Bin Huang ◽  
Bin Du
Keyword(s):  
Sensitivity Analysis ◽  
Randomized Controlled Trials ◽  
Critically Ill Patients ◽  
Oxygen Therapy ◽  
Primary Outcome ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Icu Patients ◽  
Randomized Controlled

Abstract Objective Conservative oxygen strategy is recommended in acute illness while its benefit in ICU patients remains controversial. Therefore, we sought to conduct a systematic review and meta-analysis to examine such oxygen strategies’ effect and safety in ICU patients. Methods We searched PubMed, Embase, and the Cochrane database from inception to Feb 15, 2021. Randomized controlled trials (RCTs) that compared a conservative oxygen strategy to a conventional strategy in critically ill patients were included. Results were expressed as mean difference (MD) and risk ratio (RR) with a 95% confidence interval (CI). The primary outcome was the longest follow-up mortality. Heterogeneity, sensitivity analysis, and publication bias were also investigated to test the robustness of the primary outcome. Results We included seven trials with a total of 5265 patients. In general, the conventional group had significantly higher SpO2 or PaO2 than that in the conservative group. No statistically significant differences were found in the longest follow-up mortality (RR, 1.03; 95% CI, 0.97–1.10; I2=18%; P=0.34) between the two oxygen strategies when pooling studies enrolling subjects with various degrees of hypoxemia. Further sensitivity analysis showed that ICU patients with mild-to-moderate hypoxemia (PaO2/FiO2 >100 mmHg) had significantly lower mortality (RR, 1.24; 95% CI, 1.05–1.46; I2=0%; P=0.01) when receiving conservative oxygen therapy. These findings were also confirmed in other study periods. Additional, secondary outcomes of the duration of mechanical ventilation, the length of stay in the ICU and hospital, change in sequential organ failure assessment score, and adverse events were comparable between the two strategies. Conclusions Our findings indicate that conservative oxygen therapy strategy did not improve the prognosis of the overall ICU patients. The subgroup of ICU patients with mild to moderate hypoxemia might obtain prognosis benefit from such a strategy without affecting other critical clinical results.

scholarly journals Evaluation of Nimotuzumab for the treatment of head and neck cancer: Meta-analysis of controlled trials

Bionatura ◽  
2020 ◽  
Vol 5 (1) ◽  
pp. 1056-1062
Author(s):  
Carmen Viada ◽  
Aliz M. Vega ◽  
Mayte Robaina ◽  
Aliuska Frías ◽  
Mabel Álvarez ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Sensitivity Analysis ◽  
Head And Neck Cancer ◽  
Head And Neck ◽  
Phase Ii ◽  
Neck Cancer ◽  
Meta Analysis ◽  
Sufficient Evidence ◽  
Forest Plot ◽  
Controlled Trials

Nimotuzumab, humanized monoclonal antibody, directed against the epidermal growth factor receptor: highly expressed protein in malignant tumors of epithelial origin. It has been registered for head and neck tumors since 2002. To determine the effectiveness of Nimotuzumab in head and neck cancer through the combined meta-analysis technique. A search was conducted in PubMed, in an indexed magazine with the words “Nimotuzumab”, “head and neck,” 48 articles published by Cuban and foreign authors were detected between April 1, 2005, and July 31, 2019, in which the results of clinical studies conducted with the monoclonal antibody Nimotuzumab are described. Seven clinical trials conducted in Cuba from 2005-2019 with Nimotuzumab are described; three Phase I / II (with 14, 10 and 10 patients respectively), a Phase II / III with 106 patients, a Phase II with 37 patients, two Phase IV (with 386 and 225 patients each) and a study promoted by the Researcher with 17 patients. From these studies, the three controlled trials were selected by the PRISMA flow chart. The meta-analysis consisted of the construction of the Forest Plot graph, the sensitivity analysis and the cumulative analysis. The meta-analysis shows favorable results for Nimotuzumab, without heterogeneity (I2 = 0%). The sensitivity analysis reveals that the test that differs most from the others is Phase II / III. The cumulative analysis indicates that after the second trial, there is already sufficient evidence.

scholarly journals Meta-Analysis of Randomized Controlled Trials on the Efficacy of Di’ao Xinxuekang Capsule and Isosorbide Dinitrate in Treating Angina Pectoris

2012 ◽  
Vol 2012 ◽  
pp. 1-8 ◽  
Author(s):  
Yongliang Jia ◽  
Cong Chen ◽  
Choi-San Ng ◽  
Siu-Wai Leung
Keyword(s):  
Sensitivity Analysis ◽  
Angina Pectoris ◽  
Randomized Controlled Trials ◽  
Isosorbide Dinitrate ◽  
Subgroup Analysis ◽  
Meta Analysis ◽  
Effect Sizes ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Study Characteristics

Objective. Randomized controlled trials (RCTs) on di’ao xinxuekang capsule (XXK) in treating angina pectoris were published only in Chinese and have not been systematically reviewed particularly for comparing XXK with isosorbide dinitrate (ISDN). This study aims to provide a comprehensive PRISMA compliant and internationally accessible systematic review and meta-analysis to evaluate the efficacies of XXK and ISDN in treating angina pectoris.Methods. The RCTs published between 1989 and 2011 on XXK and ISDN in treating angina pectoris were selected according to specific criteria. Meta-analysis was performed to evaluate the symptomatic (SYMPTOMS) and electrocardiographic (ECG) improvements after treatment. Odds ratios (OR) were used to measure effect sizes. Subgroup analysis, sensitivity analysis, and metaregression were conducted to evaluate the robustness of the results.Results. Seven RCTs with 550 participants were eligible. Overall ORs for comparing XXK with ISDN were 4.11 (95% CI :  2.57, 6.55) in SYMPTOMS and 2.37 (95% CI : 1.46, 3.84) in ECG. Subgroup analysis, sensitivity analysis, and metaregression found no significant dependence of overall ORs upon specific study characteristics.Conclusion. The meta-analysis of eligible but limited RCTs demonstrates that XXK seems to be more effective than ISDN in treating angina pectoris. Further RCTs of high quality are warranted to be conducted for update of the results of this meta-analysis.

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 Effect of Epidural Dexmedetomidine as an Adjuvant to Local Anesthetics for Labor Analgesia: A Meta-Analysis of Randomized Controlled Trials

2021 ◽  
Vol 2021 ◽  
pp. 1-11
Author(s):  
Nijuan Li ◽  
Li Hu ◽  
Chunping Li ◽  
Xuelin Pan ◽  
Yong Tang
Keyword(s):  
Sensitivity Analysis ◽  
Randomized Controlled Trials ◽  
Local Anesthetics ◽  
Analgesic Effect ◽  
Meta Analysis ◽  
Labor Analgesia ◽  
Labor Pain ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Significant Difference

Background. This study aims to determine the analgesic effect and safety of dexmedetomidine as an adjuvant to epidural local anesthetics during labor. Methods. Randomized controlled trials comparing epidural blocks with or without dexmedetomidine for labor analgesia were comprehensively searched. Review manager 5.4 was used to analyze the extracted data. Results. Compared with placebo and opioids, dexmedetomidine relieved labor pain of 15 min ( P = 0.002 ), 30 min ( P = 0.01 ), and 120 min ( P = 0.02 ) after block and at the moment of fetal disengagement ( P = 0.0002 ), decreased mean arterial pressure of 120 min ( P = 0.01 ), heart rate of 30 min ( P = 0.003 ), 60 min ( P < 0.00001 ), and 120 min ( P < 0.00001 ) after block, blood loss ( P = 0.02 ), and the incidence of nausea/vomiting ( P = 0.006 ), and increased the incidence of maternal bradycardia ( P = 0.04 ). However, sensitivity analysis only found that the incidence of nausea/vomiting was significantly different. Compared with placebo, dexmedetomidine relieved labor pain of 30 min after block ( P < 0.00001 ) and did not increase the incidences of side effects, but only two studies were enrolled. Compared with opioids, dexmedetomidine decreased the incidence of nausea/vomiting ( P = 0.002 ), increased the incidence of maternal bradycardia ( P = 0.04 ), and had a similar effect on labor pain relief; however, sensitivity analysis found that significant difference existed only at the incidence of nausea/vomiting. Other outcomes from meta-analysis or subgroup analysis were not different. Conclusions. Epidural dexmedetomidine has the potential to offer a better analgesic effect than placebo, similar labor pain control to opioids, and has no definite adverse effects on the parturient or fetus, but more high-quality studies are needed to confirm these conclusions.

Profiling Inflammatory Cytokines Following Zinc Supplementation: A Systematic Review and Meta-analysis of Randomized Controlled Trials

2021 ◽  
pp. 1-28
Author(s):  
Amir Hossein Faghfouri ◽  
Behzad Baradaran ◽  
Alireza Khabbazi ◽  
Yaser Khaje Bishak ◽  
Meysam Zarezadeh ◽  
...  
Keyword(s):  
Systematic Review ◽  
Sensitivity Analysis ◽  
Inflammatory Cytokines ◽  
Meta Analysis ◽  
Random Effect ◽  
Random Effect Model ◽  
Controlled Trials ◽  
Tnf Α ◽  
Trim And Fill ◽  
The Impact

Abstract Chronic inflammation has been considered as the main cause of chronic diseases. Zn has anti-inflammatory effects by decreasing the expression of inflammatory markers. The present systematic review and meta-analysis study aims to evaluate the impact of Zn supplementation on inflammation. Pubmed (Medline), Scopus, Web of Science, and Embase databases were searched up to December 10th, 2020. Randomized placebo-controlled trials have investigated the effects of Zn supplementation on serum/plasma levels of inflammatory cytokines in >15 years’ subjects were included. A pooled meta-analysis was performed using a random-effect model. Sensitivity analysis was performed to determine the robustness of the observed effect sizes. Potential causes of heterogeneity were determined using subgroup analyses. The relationship between effect size and co-variables was explored using meta-regression. In the cases of the presence of publication bias, trim and fill analysis was carried out. Cochrane Collaboration’s tool was used for assessing the quality of the included studies. A total of 12 studies was included in meta-analysis. Zn could decrease IL-6 levels (SMD= -0.76 pg/ml; 95% CI: -1.28, -0.24; P= 0.004). There was no significant change in TNF-α (SMD= 0.42 pg/ml; 95% CI: -0.31, 1.16; P= 0.257) and IL-2 levels (SMD= 1.64 pg/ml; 95% CI: -1.31, 4.59; P= 0.277) following Zn supplementation. However, Zn could increase IL-2 significantly after deletion of one arm in sensitivity analysis (SMD= 2.96 pg/ml; 95% CI: 2.03, 3.88; P< 0.05). Conclusively, Zn supplementation can decrease the IL-6 level. Zn increased IL-2 level after sensitivity analysis. Zn supplementation has not ameliorative effects on TNF-α.

scholarly journals Efficacy of 4% articaine vs 2% lidocaine in mandibular and maxillary block and infiltration anaesthesia in patients with irreversible pulpitis: a systematic review and meta-analysis

PeerJ ◽  
2021 ◽  
Vol 9 ◽  
pp. e12214
Author(s):  
Sanjay Miglani ◽  
Irfan Ansari ◽  
Swadheena Patro ◽  
Ankita Mohanty ◽  
Shahnaz Mansoori ◽  
...  
Keyword(s):  
Systematic Review ◽  
Sensitivity Analysis ◽  
Success Rate ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Lidocaine Group ◽  
Manual Search ◽  
Mandibular Teeth ◽  
Irreversible Pulpitis

Objective The goal of this systematic review and meta-analysis is to determine the performance of 4% Articaine vs. 2% Lidocaine for mandibular and maxillary block and infiltration anaesthesia in patients with irreversible pulpitis (IP). Methods PubMed/MEDLINE, Cochrane Central Register of Controlled Trials, Web of Science, Google Scholar, and Open Gray were used to conduct a thorough literature search. A manual search of the reference lists of the publications found was also carried out. Two reviewers critically evaluated the papers for inclusion and exclusion criteria, and data extraction was done on the selected publications. The Cochrane Collaboration Tool and the Minors checklist were used to assess the quality of the selected studies for randomised controlled trials (RCTs) and non-randomised studies, respectively. The RevMan software was used to perform a meta-analysis of the pooled data and subgroups according to the technique of anaesthetic solution delivery, as well as a sensitivity analysis (P < 0.05). Results A total of twenty-six papers were included in the qualitative synthesis, with twenty-two of them being included in the meta-analysis. There were fifteen studies with a low potential for bias, three with a moderate potential for bias, and seven with a high potential for bias. The combined results of the 19 trials in the tooth level unit revealed that 4% articaine had a success rate 1.37 times greater than 2% lidocaine for mandibular teeth (RR, 1.37; 95% CI [1.17–1.62]; P = 0.0002). For the maxillary buccal infiltration method, the combined results from the three trials revealed that 4% articaine resulted in a success rate 1.06 times greater than 2% lidocaine (RR, 1.06; 95% CI [0.95–1.2]; P = 0.3). Excluding subgroups with a single study in sensitivity analysis for mandibular teeth revealed a substantial improvement in the success rate of the articaine group in treating IP when compared to the lidocaine group. Conclusion The findings of this meta-analysis back up the claim that articaine is more effective than lidocaine in providing anaesthesia in patients with IP. PROSPERO Registration No.: CRD42020204606 (https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020204606).

Abstract T MP119: Recombinant Tissue Plasminogen Activator Does Not Impact Mortality in Acute Ischemic Stroke: A Meta-analysis of Randomized Controlled Trials

Stroke ◽  
2015 ◽  
Vol 46 (suppl_1) ◽  
Author(s):  
Drew Uhrig ◽  
Gyanendra Kumar ◽  
Susan Fowler ◽  
Andrei Alexandrov
Keyword(s):  
Sensitivity Analysis ◽  
Plasminogen Activator ◽  
Tissue Plasminogen Activator ◽  
Meta Analysis ◽  
Recombinant Tissue Plasminogen Activator ◽  
Controlled Trials ◽  
Significant Difference ◽  
Tissue Plasminogen ◽  
Mortality Estimates ◽  
Time Point

Background: Currently there is still some reluctance among emergency physicians and even neurologists to prescribe recombinant tissue plasminogen activator (rt-PA) for acute stroke. The majority of those unlikely to use it are concerned about causing harm to their patient. The object of this meta-analysis was to pool the mortality estimates at various time points following rt-PA administration. We hypothesized that there was a significant difference in mortality of patients treated with rt-PA and those treated with placebo. Methods: The databases PUBMED, EMBASE, SCOPUS, CENTRAL, and clinicaltrials.gov were searched for English-language randomized double blinded, placebo controlled trials of rt-PA. Mortality estimates were pooled and reported separately for days 7, 30, 90, and 180. Pooled relative risk (RR) and 95% confidence intervals were calculated using Dersimonian and Laird Random effects model. A priori designed sensitivity analyses included exclusion sensitivity analysis, and subgroup analysis into studies that included and excluded patients presenting within 3 hours of onset. Results: Eleven trials (N =6905) met the inclusion criteria. Total variance attributable to heterogeneity was not significant (I2 <50%) for any time point except at 30 days (I2, 53%). Publication bias was not significant on Begg’s and Egger’s tests. Mortality was not significantly different between the two groups at any time point. Exclusion sensitivity analysis revealed that exclusion of the NINDS trial rendered the 7 day and 30 day difference significant. Trials that randomized patients beyond 3 hours did not drive the mortality difference seen at any time point. Conclusion: In conclusion, compared with placebo, rt-PA does not impact mortality at any time point after administration through 6 months.

scholarly journals The Efficacy of Guanxinning Injection in Treating Angina Pectoris: Systematic Review and Meta-Analysis of Randomized Controlled Trials

2013 ◽  
Vol 2013 ◽  
pp. 1-16 ◽  
Author(s):  
Yongliang Jia ◽  
Siu-wai Leung ◽  
Ming-Yuen Lee ◽  
Guozhen Cui ◽  
Xiaohui Huang ◽  
...  
Keyword(s):  
Systematic Review ◽  
Sensitivity Analysis ◽  
Angina Pectoris ◽  
Randomized Controlled Trials ◽  
Subgroup Analysis ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Eligibility Criteria ◽  
Randomized Controlled ◽  
Study Characteristics

Objective. The randomized controlled trials (RCTs) on Guanxinning injection (GXN) in treating angina pectoris were published only in Chinese and have not been systematically reviewed. This study aims to provide a PRISMA-compliant and internationally accessible systematic review to evaluate the efficacy of GXN in treating angina pectoris.Methods. The RCTs were included according to prespecified eligibility criteria. Meta-analysis was performed to evaluate the symptomatic (SYMPTOMS) and electrocardiographic (ECG) improvements after treatment. Odds ratios (ORs) were used to measure effect sizes. Subgroup analysis, sensitivity analysis, and metaregression were conducted to evaluate the robustness of the results.Results. Sixty-five RCTs published between 2002 and 2012 with 6064 participants were included. Overall ORs comparing GXN with other drugs were 3.32 (95% CI: [2.72, 4.04]) in SYMPTOMS and 2.59 (95% CI: [2.14, 3.15]) in ECG. Subgroup analysis, sensitivity analysis, and metaregression found no statistically significant dependence of overall ORs upon specific study characteristics.Conclusion. This meta-analysis of eligible RCTs provides evidence that GXN is effective in treating angina pectoris. This evidence warrants further RCTs of higher quality, longer follow-up periods, larger sample sizes, and multicentres/multicountries for more extensive subgroup, sensitivity, and metaregression analyses.

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