Risk of bias assessment of randomised controlled trials referenced in the 2015 American Heart Association guidelines update for cardiopulmonary resuscitation and emergency cardiovascular care: a cross-sectional review

Cho, Yongil; Kim, Changsun; Kang, Bossng

doi:10.1136/bmjopen-2018-023725

Cited by 17 publications

(11 citation statements)

References 37 publications

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“…Our investigation has shown that drug trials had favourable impact on RoB than non drug trials, which might be related with the strict regulations these pharmaceuticals trials must follow. Similarly, Cho Y et al, found that most of drug trials were at low risk of bias for blinding of participants and personnel, while almost two third of non drug trials were at high risk of bias for blinding of participants and personnel in cardiopulmonary resuscitation and emergency cardiovascular care (24).…”

Section: Discussion Of Findings Considering Other Studiesmentioning

confidence: 98%

Change over five years in important measures of methodological quality and reporting in cardiovascular clinical research trials

Baasan

Freihat

Nagy

et al. 2023

Preprint

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Objectives The aim of our current study was to analyze whether important measures of methodological quality and reporting of randomized controlled trials published in the field of cardiovascular disease research changed over time. Further aim was to investigate whether there was an improvement over time in the ability of these trials to provide a good estimate of the true intervention effect. Methods We conducted two separate searches in the Cochrane Central Register of Controlled Trials (CENTAL) database to identify cardiovascular clinical research trials published in either 2012 or 2017. Randomized controlled trials (RCTs) trials in cardiovascular disease research with adult participants were eligible to be included. We randomly selected 250 RCTs for both publication year 2012 and 2017. Trial characteristics, data on measures of methodological quality and reporting were extracted and risk of bias for each trial was assessed. Results As compared to 2012 in 2017 there were significant changes in important measures of methodological quality and reporting, including an improvement in the reporting of the presence of a data monitoring committee (42.0% vs. 34.4%), and a positive tendency of registering cardiovascular disease research RCTs in clinical trial registries (83.6% vs. 72.0%). On the other hand, we also observed that significantly fewer RCTs reported sample size calculation (60.4% vs. 98.4%) in 2017 as compared to 2012. RCTs in 2017 were more likely to have low overall RoB than in 2012 (29.2% vs. 21.2%). However, the 5-year-change was not clearly in the direction of improvement for all RoB domains. In 2017 multicenter trials, drug trials and registered trials were also more likely to have a low overall RoB, than single center, non-drug on non-registered trials. In 2012 specific trial characteristics had not yet a significant impact on overall RoB. Conclusion: As compared to 2012 in 2017 there were significant improvement in some, but not all the important measures of methodological quality. Although more trials in the field of cardiovascular disease research had a lower overall RoB in 2017, the improvement over time was not consistently perceived in all RoB domains.

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Section: Discussion Of Findings Considering Other Studiesmentioning

confidence: 98%

Change over five years in important measures of methodological quality and reporting in cardiovascular clinical research trials

Baasan

Freihat

Nagy

et al. 2023

Preprint

View full text Add to dashboard Cite

show abstract

“…Although these data are limited to the clinical topic areas covered by the Cochrane MOSS network, prior research has reported similar percentages of high or unclear risk of bias across many different clinical areas. [ 23 , 24 ] It is important to note that risk of bias assessments are driven by two factors – the reporting of methods and the actual methods – and interpretation of unclear or high risk may conflate the two. Another possibility for the high number of unclear and high risk of bias assessments could be the misinterpretation of the first version of the Cochrane Risk of Bias tool.…”

Section: Discussionmentioning

confidence: 99%

Clinical trial registration was associated with lower risk of bias compared with non-registered trials among trials included in systematic reviews

Lindsley¹,

Fusco²,

Li³

et al. 2022

Journal of Clinical Epidemiology

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“…Individual study definitions were used for the outcome analysis (see Additional file 2 : Table S2 for details). The potential risk of bias of the included RCTs was evaluated using the risk assessment tool recommended by the Cochrane Collaboration guidelines (assessing random sequence generation; allocation concealment; blinding of participants and personnel; blinding of outcome assessment; incomplete outcome data; selective reporting; and other risk) [ 25 ].…”

Section: Methodsmentioning

confidence: 99%

Comparative efficacy of pharmacological agents on reducing the risk of major adverse cardiovascular events in the hypertriglyceridemia population: a network meta-analysis

Yan²,

Wang

et al. 2021

Diabetol Metab Syndr

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Background Hypertriglyceridemia (HTG) is considered an independent risk factor for major adverse cardiovascular events (MACE). Methods This study analyzed the effects of various agents on MACE risk reduction in HTG (serum triglyceride ≥ 150 mg/dl) populations by performing a network meta-analysis. We performed a frequentist network meta-analysis to conduct direct and indirect comparisons of interventions. PubMed, EMBASE, and the Cochrane library were searched for trials until Jul 6, 2020. Randomized controlled trials that reported MACE associated with agents in entire HTG populations or in subgroups were included. The primary outcome was MACE. Results Of the 2005 articles screened, 21 trials including 56,471 patients were included in the analysis. The network meta-analysis results for MACE risk based on frequency data showed that eicosapentaenoic acid (EPA) (OR: 1.32; 95% CI 1.19–1.46), gemfibrozil (OR: 1.53; 95% CI 1.20–1.95), niacin plus clofibrate (OR: 2.00; 95% CI 1.23–3.25), pravastatin (OR: 1.32; 95% CI 1.15–1.52), simvastatin (OR: 2.38; 95% CI 1.55–3.66), and atorvastatin (OR: 0.55; 95% CI 0.37–0.82) significantly reduced the risk of MACE compared to the control conditions. In the subgroup analysis of HTG patients with triglycerides ≥ 200 mg/dL, bezafibrate (OR: 0.56; 95% CI 0.33–0.94), EPA (OR: 0.72; 95% CI 0.62–0.82), and pravastatin (OR: 1.33; 95% CI 1.01–1.75) significantly reduced the MACE risk. Conclusions Simvastatin had a clear advantage in reducing the risk of MACE in the entire HTG population analyzed in this meta-analysis. EPA, but not omega-3 fatty acid, was considered an effective HTG intervention. Among fibrates, gemfibrozil was most effective, though bezafibrate may significantly reduce the risk of MACE in populations with triglyceride levels of 200–300 mg/dL. Trial registration retrospectively registered in PROSPERO (CRD42020213705).

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Risk of bias assessment of randomised controlled trials referenced in the 2015 American Heart Association guidelines update for cardiopulmonary resuscitation and emergency cardiovascular care: a cross-sectional review

Cited by 17 publications

References 37 publications

Change over five years in important measures of methodological quality and reporting in cardiovascular clinical research trials

Change over five years in important measures of methodological quality and reporting in cardiovascular clinical research trials

Clinical trial registration was associated with lower risk of bias compared with non-registered trials among trials included in systematic reviews

Comparative efficacy of pharmacological agents on reducing the risk of major adverse cardiovascular events in the hypertriglyceridemia population: a network meta-analysis

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