Softness (2022)

Bladder cancer

Oncology • National_Database Data • US

Study Metrics
Total Sample 2048
Treatment Group 1812
Control Group 236
Covariates 16
PICO Comparisons 1
Quality Indicators
Transparency High
DAG Usage No
QBA Performed No

Study Information

First Author: Softness
Publication Year: 2022
DOI: https://doi.org/10.1016/j.urolonc.2021.12.015
Preprint: No preprint

Institution & Funding

Institution Type: Academic
Institutions: Beth Israel Deaconess Medical Center, Massachusetts General Hospital, University of Colorado
Funding: Not declared

Study Context

Disease: Bladder cancer
Disease Category: Oncology
Data Type: national_database
Number of Data Sources: 1
Geography: US
Eligible Sample: 2048.0

Analytical Methods

Missing Data Method: Complete case
Matching Method: IPTW
Analysis Method: Cox PH

Quality Methods

Directed Acyclic Graph (DAG) Not Used
Quantitative Bias Analysis (QBA) Not Performed

Target Trial Information

Target Trial Name: SPARE
Registration Number: ISRCTN61126465
Target Trial DOI: https://doi.org/10.1111/bju.13900

TTE vs RCT Comparisons

Detailed comparison between Target Trial Emulation results and corresponding Randomized Controlled Trial outcomes.

Overall survival
SPARE
HR Efficacy
Population

patients aged 40 to 79 with cT2-3cN0cM0 urothelial carcinoma of the bladder

Intervention

Radical cystectomy (RC) with lymphadenectomy

Comparison

Trimodality therapy (TMT)

Outcome

Overall survival

RCT Result

3.05

95% CI: [0.92, 10.15]


vs
TTE Result

0.87

95% CI: [0.64, 1.19]

Concordance Assessment
Confidence Interval Overlap: Yes
CIs overlap, suggesting concordance
Direction Agreement: Different Direction
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: Not declared