Methodological Quality and Risk of Bias Assessment of Cardiovascular Disease Research: Analysis of Randomized Controlled Trials Published in 2017

Baasan, Odgerel; Freihat, Omar; Nagy, Dávid U.; Lohner, Szimonetta

doi:10.3389/fcvm.2022.830070

Cited by 3 publications

(8 citation statements)

References 26 publications

(26 reference statements)

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“…Statistical analyses were conducted by the statistical software R version 4.1.2 (R Development Core Team 2021) [17]. To analyze for 5-year changes in main study characteristics, we compared the 2017 sample with 250 RCTs published in 2012 [15]. All collected binomial variables were analyzed using logistic regression analyses with generalized linear models.…”

Section: Discussionmentioning

confidence: 99%

“…We used a data extraction tool that was developed for assessing the methodological quality of RCTs in child health research [15]. Two authors (OB, OF) independently extracted data for each study included.…”

Section: Methodsmentioning

confidence: 99%

“…The main characteristics of included cardiovascular RCTs are shown in Table 1. Data from 2017 have been previously partly reported [15]. Values from 2012, some data on additional measures of methodological quality and reporting for both years and statistical comparisons were novel.…”

Section: Descriptive Analysismentioning

confidence: 99%

“…Our previous study compared the risk of bias in industry-funded and non-industryfunded cardiovascular disease research trials published in 2017 [15]. The present study investigated tendencies over time to answer whether there was an improvement in measures of methodological quality and reporting in randomized cardiovascular clinical trials between 2012 and 2017.…”

Section: Introductionmentioning

confidence: 96%

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Change over Five Years in Important Measures of Methodological Quality and Reporting in Randomized Cardiovascular Clinical Trials

Baasan,

Freihat,

Nagy

et al. 2023

JCDD

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Objectives: The aim of our current study was to analyze whether the use of important measures of methodological quality and reporting of randomized clinical trials published in the field of cardiovascular disease research haschanged over time. A furtheraim 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 searches in the Cochrane Central Register of Controlled Trials (CENTAL) database to identify randomized cardiovascular clinical trials published in either 2012 or 2017. Randomized clinical trials (RCTs) trials in cardiovascular disease research with adult participants were eligible to be included. We randomly selected 250 RCTs for publication years 2012 and 2017. Trial characteristics, data on measures of methodological quality, and reporting were extracted and the risk of bias for each trial was assessed. Results: As compared to 2012, in 2017 there were significant improvements in the reporting of the presence of a data monitoring committee (42.0% in 2017 compared to 34.4% in 2012; p < 0.001), and a positive change in registering randomized cardiovascular disease research in clinical trial registries (78.4% in 2017 compared to 68.9% in 2012; p = 0.03). We also observed that significantly more RCTs reported sample size calculation (60.4% in 2017 compared to 49.6% in 2012; p < 0.01) in 2017 as compared to 2012. RCTs in 2017 were more likely to have a low overall risk of bias (RoB) than in 2012 (29.2% in 2017 compared to 21.2% in 2012; p < 0.01). However, fewer 2017 RCTs were rated low (50.8% compared to 65.6%; p < 0.001) risk for blinding of participants and personnel, for blinding of outcome assessors (82.4% compared to 90.8%; p < 0.001), and selective outcome reporting (62.8% compared to 80.0%; <0.001). Conclusions: As compared to 2012, in 2017 there were significant improvements 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: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Descriptive Analysismentioning

confidence: 99%

Section: Introductionmentioning

confidence: 96%

See 2 more Smart Citations

Change over Five Years in Important Measures of Methodological Quality and Reporting in Randomized Cardiovascular Clinical Trials

Baasan,

Freihat,

Nagy

et al. 2023

JCDD

Self Cite

View full text Add to dashboard Cite

show abstract

“…The main characteristics of included cardiovascular RCTs are shown in Table I. Data from 2017 have been previously partly reported (14). Values from 2012, some data on additional measures of methodological quality and reporting for both years and statistical comparisons are novel.…”

Section: Descriptive Analysismentioning

confidence: 99%

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

Baasan

Freihat

Nagy

et al. 2023

Preprint

Self Cite

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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.

show abstract

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

Objectives: The aim of our current study was to analyze whether the use of important measures of methodological quality and reporting of randomized clinical trials published in the field of cardiovascular disease research have 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 searches in the Cochrane Central Register of Controlled Trials (CENTAL) database to identify cardiovascular clinical research trials published in either 2012 or 2017. Randomized clinical 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 improvements in the reporting of the presence of a data monitoring committee (42.0% in 2017 compared to 34.4% in 2012), and a positive tendency of registering cardiovascular disease research RCTs in clinical trial registries (83.6% in 2017 compared to 72.0% in 2012). On the other hand, we also observed that significantly fewer RCTs reported sample size calculation (60.4% in 2017 compared to 98.4% in 2012) in 2017 as compared to 2012. RCTs in 2017 were more likely to have low overall risk of bias ( RoB ) than in 2012 (29.2% in 2017compared to 21.2% in 2012). 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.

show abstract

Methodological Quality and Risk of Bias Assessment of Cardiovascular Disease Research: Analysis of Randomized Controlled Trials Published in 2017

Cited by 3 publications

References 26 publications

Change over Five Years in Important Measures of Methodological Quality and Reporting in Randomized Cardiovascular Clinical Trials

Change over Five Years in Important Measures of Methodological Quality and Reporting in Randomized Cardiovascular Clinical Trials

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

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