All studies
Cardiology · EHR + National database · UK

Powell 2024

Atrial fibrillation

ITT, PPNon-inferiorityAcademia, Industry3/5 disclosures
Comparisons
8
In the analysis
8
all comparisons pooled
Target trials
1
Emulations reported
1
2 treatments

Comparisons

8 shown
Randomized trialEmulation
Outcome & target trialTrial vs emulationOn a shared scaleAgreement
Death from any cause
vs ARISTOTLE·HR·Efficacy
0.890.80–1.00
1.030.93–1.14
overlap1.91 SE apart
Gastrointestinal bleeding
vs ARISTOTLE·HR·Safety
0.890.70–1.15
0.880.74–1.04
overlap-0.07 SE apart
Hemorrhagic stroke
vs ARISTOTLE·HR·Efficacy
0.510.35–0.75
0.670.44–1.01
overlap0.95 SE apart
Intracranial bleeding
vs ARISTOTLE·HR·Safety
0.420.30–0.58
0.710.51–1.00
overlap2.18 SE apart
Ischemic or uncertain stroke
vs ARISTOTLE·HR·Efficacy
0.920.74–1.13
1.130.90–1.41
overlap1.31 SE apart
Major bleeding
vs ARISTOTLE·HR·Safety
0.690.60–0.80
0.880.77–1.00
overlap2.45 SE apart
Other location bleeding
vs ARISTOTLE·HR·Safety
0.790.68–0.93
0.930.70–1.22
overlap1.00 SE apart
Stroke or systemtic embolism
vs ARISTOTLE·HR·Efficacy
0.790.66–0.95
0.980.82–1.19
overlap1.62 SE apart

Design and methods

Estimand
ITT, PP
Design hypothesis
Non-inferiority
Matching / weighting
Coarsened exact matching, PS matching
Analysis method
Cox PH
Missing data
Complete case
Covariates adjusted
41
DAG
No
QBA
No

Data and sample

Data type
EHR + National database
Data sources
3
Geography
UK
Eligible sample
67539
Treated
8846
Control
8846
Emulations
1
Treatments compared
2

Transparency

3/5
Protocol
No pre-registration
Preprint
https://dx.doi.org/10.1101/2024.03.18.24304452
Data availability
Unavailable
Code availability
https://datacompass.lshtm.ac.uk/id/eprint/3590/
Conflicts of interest
Declared: Industry, NGO
COI institutions
GSK, Compass Pathways, AstraZeneca, British Heart Foundation
Funding
Declared: Public, NGO
Funders
UK Medical Research Council, Barts Charity

The 0-5 count records which disclosures are present. It is not a quality score: a data link does not establish that the data are reusable.

Provenance

Review key
2024_Powell_AtrialFibrillation
DOI
https://dx.doi.org/10.1371/journal.pmed.1004377
Affiliations
London School of Hygiene and Tropical Medicine, GSK, Queen Mary University of London, Saudi Food and Drug Authority, University of Glasgow
Sector
Academia, Industry
Target trials (study level)
ARISTOTLE
Registration
NCT00412984