Study Metrics
Total Sample
25473
Treatment Group
4008
Control Group
21465
Covariates
32
PICO Comparisons
3
Quality Indicators
Transparency
High
DAG Usage
No
QBA Performed
No
Study Information
| First Author: | Althunian |
| Publication Year: | 2020 |
| DOI: | https://doi.org/10.1002/pds.5065 |
| Preprint: | No preprint |
Institution & Funding
| Institution Type: | Academic |
| Institutions: | Utrecht University, Dutch Medicines Evaluation Board |
| Funding: | Declared: Public |
| Funding Institutions: | Saudi Food and Drug Authority (SFDA) |
Study Context
| Disease: | Atrial fibrilation |
| Disease Category: | Cardiology |
| Data Type: | national_database |
| Number of Data Sources: | 1 |
| Geography: | UK |
| Eligible Sample: | 25473.0 |
| Number of Treatments: | 2 |
Analytical Methods
| Missing Data Method: | Multiple imputation |
| Analysis Method: | Cox PH |
Quality Methods
Directed Acyclic Graph (DAG)
Not Used
Quantitative Bias Analysis (QBA)
Not Performed
Target Trial Information
| Target Trial Name: | Rocket AF |
| Registration Number: | NCT00403767 |
| Target Trial DOI: | https://doi.org/10.1056/NEJMoa1009638 |
TTE vs RCT Comparisons
Detailed comparison between Target Trial Emulation results and corresponding Randomized Controlled Trial outcomes.
major bleeding
Rocket AF
HR
Efficacy
Population
patients with atrial fibrillation
Intervention
rivaroxaban
Comparison
warfarin
Outcome
major bleeding
RCT Result
1.04
95% CI: [0.90, 1.20]
vs
TTE Result
1.07
95% CI: [0.95, 1.21]
Concordance Assessment
Confidence Interval Overlap:
Yes
CIs overlap, suggesting concordance
CIs overlap, suggesting concordance
Direction Agreement:
Same Direction
Both point to similar conclusion
Both point to similar conclusion
stroke, systemic emoblism, death
Rocket AF
HR
Efficacy
Population
patients with atrial fibrillation
Intervention
rivaroxaban
Comparison
warfarin
Outcome
stroke, systemic emoblism, death
RCT Result
0.86
95% CI: [0.74, 0.99]
vs
TTE Result
1.18
95% CI: [1.03, 1.34]
Concordance Assessment
Confidence Interval Overlap:
No
CIs do not overlap
CIs do not overlap
Direction Agreement:
Different Direction
Different conclusions
Different conclusions
stroke, systemic emoblism prevention
Rocket AF
HR
Efficacy
Population
patients with atrial fibrillation
Intervention
rivaroxaban
Comparison
warfarin
Outcome
stroke, systemic emoblism prevention
RCT Result
0.88
95% CI: [0.75, 1.03]
vs
TTE Result
1.04
95% CI: [0.84, 1.30]
Concordance Assessment
Confidence Interval Overlap:
Yes
CIs overlap, suggesting concordance
CIs overlap, suggesting concordance
Direction Agreement:
Different Direction
Different conclusions
Different conclusions
Transparency Indicators
Protocol Registration
Available
Data Sharing
Not Available
Code Sharing
Not Available
Overall Transparency Score:
High Transparency - This study meets good transparency standards.
Conflicts & Funding
| Conflicts of Interest: | Declared: None |
| Funding Source: | Declared: Public |
| Funding Institutions: | Saudi Food and Drug Authority (SFDA) |