Signori (2024)
Multiple sclerosis
Neurology • Registry Data • Italy, Australia, Turkey, Czech Republic, Kuwait, Switzerland, Spain, Lebanon, Canada
Study Metrics
Total Sample
4376
Treatment Group
3236
Control Group
1140
Covariates
7
PICO Comparisons
1
Quality Indicators
Transparency
High
DAG Usage
No
QBA Performed
No
Study Information
| First Author: | Signori |
| Publication Year: | 2024 |
| DOI: | https://doi.org/10.1136/jnnp-2023-332603 |
| Preprint: | No preprint |
Institution & Funding
| Institution Type: | Academic |
| Institutions: | University of Genova, University of Melbourne, Dokuz Eylul University, Charles University, Amiri Hospital, University of Catania, University Hospital Basel, Hospital Universitario Virgen Macarena, American University of Beirut Medical Center, Hacettepe University, Hotel-Dieu de Levis, Université de Montréal, Monash University, Alfred Hospital, Ospedale Policlinico San Martino |
| Funding: | Declared: None |
| Funding Institutions: | The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors. |
Study Context
| Disease: | Multiple sclerosis |
| Disease Category: | Neurology |
| Data Type: | Registry |
| Number of Data Sources: | 1 |
| Geography: | Italy, Australia, Turkey, Czech Republic, Kuwait, Switzerland, Spain, Lebanon, Canada |
| Eligible Sample: | 4376.0 |
| Number of Emulations: | 1 |
| Number of Treatments: | 2 |
Analytical Methods
| Matching Method: | 1:1 PS matching |
| Analysis Method: | Negative binomial regression, standard and ordinal logistic regression, linear regression |
Quality Methods
Directed Acyclic Graph (DAG)
Not Used
Quantitative Bias Analysis (QBA)
Not Performed
Target Trial Information
| Target Trial Name: | TRANSFORMS |
| Registration Number: | NCT00340834 |
| Target Trial DOI: | https://doi.org/10.1056/NEJMoa0907839 |
TTE vs RCT Comparisons
Detailed comparison between Target Trial Emulation results and corresponding Randomized Controlled Trial outcomes.
Annual relapse rate
TRANSFORMS
RR
Efficacy
Population
Patients aged 18-55 years with relapsing-remitting multiple sclerosis (RRMS)
Intervention
Fingolimod (FTY) 0.5mg daily
Comparison
Intramuscular interferon β-1a (IFN) 30μg weekly
Outcome
Annual relapse rate
RCT Result
0.49
95% CI: [0.37, 0.64]
vs
TTE Result
0.55
95% CI: [0.45, 0.68]
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
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: Financial |
| COI Institutions: | Chiesi, BMS, Roche, Janssen, Sanofi Genzyme, Novartis, Merck, Biogen, WebMD Global, Eisai, BioCSL, Celgene, Teva, Bayer, GSK, Almirall, EMD Serono, Alexion, CSL, Pendopharm, Geneuro, Immunic, Medday |
| Funding Source: | Declared: None |
| Funding Institutions: | The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors. |