Study Metrics
Total Sample
3836
Treatment Group
1299
Control Group
2537
Covariates
28
PICO Comparisons
1
Quality Indicators
Transparency
High
DAG Usage
No
QBA Performed
No
Study Information
| First Author: | Merola |
| Publication Year: | 2023 |
| DOI: | https://doi.org/10.1002/pds.5565 |
| Preprint: | No preprint |
Institution & Funding
| Institutions: | Brigham and Women's Hospital, Harvard Medical School, Harvard TH Chan School of Public Health, Harvard Pilgrim Health Care Institute, Memorial Sloan Kettering Cancer Center, Weill Cornell Medical School, Massachusetts General Hospital, Avalere Health |
| Funding: | Delcared: NGO |
| Funding Institutions: | This project was funded by an Innovation in Regulatory Science Award from the Burroughs Wellcome Fund (#1020021). |
Study Context
| Disease: | Breast cancer |
| Disease Category: | Oncology |
| Data Type: | Electronic Health Records |
| Number of Data Sources: | 1 |
| Geography: | US |
| Eligible Sample: | 3836.0 |
Analytical Methods
| Missing Data Method: | Multiple imputation |
| Matching Method: | Stratification |
| Analysis Method: | Cox PH |
Quality Methods
Directed Acyclic Graph (DAG)
Not Used
Quantitative Bias Analysis (QBA)
Not Performed
Target Trial Information
| Target Trial Name: | PALOMA-2 |
| Registration Number: | NCT01740427 |
| Target Trial DOI: | https://doi.org/10.1007/s10549-018-05125-4 |
TTE vs RCT Comparisons
Detailed comparison between Target Trial Emulation results and corresponding Randomized Controlled Trial outcomes.
Time to next treatment (TTNT)
PALOMA-2
HR
Efficacy
Population
Women aged ≥18 with hormone-positive, HER-2 negative metastatic breast cancer
Intervention
Palbociclib + letrozole
Comparison
Letrozole
Outcome
Time to next treatment (TTNT)
RCT Result
0.64
95% CI: [0.52, 0.78]
vs
TTE Result
0.62
95% CI: [0.56, 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: | Boehringer Ingelheim, Aetion Inc., McKesson Corporation |
| Funding Source: | Delcared: NGO |
| Funding Institutions: | This project was funded by an Innovation in Regulatory Science Award from the Burroughs Wellcome Fund (#1020021). |