Design and Analysis Methods for Trials with AI-Based Diagnostic Devices for Breast Cancer
Abstract
:1. Introduction
2. Materials and Methods
2.1. Objective 1: Is the Concordance Rate between the AI-Based Device and Radiologists as High as That among Radiologists?
2.1.1. Statistical Testing Method
2.1.2. Power and Sample Size Calculation
- (1)
- Specify (), expected concordance rate among radiologists , similarity margin and hypothetical correlation coefficients and .
- (2)
- Calculate using (3).
- (3)
- Obtain sample size using (2).
2.2. Objective 2: Is the AI-Based Device More Concordant with Experienced Radiologists Than with Junior Radiologists?
2.2.1. Statistical Testing Method
2.2.2. Power and Sample Size Calculation
- 1.
- Specify (), expected concordance rate between the AI-based device and a highly experienced radiologist , clinically meaningful difference in concordance rates and correlation coefficients and .
- 2.
- Calculate using (6).
- 3.
- Obtain the required sample size using (5).
3. Numerical Studies and Results
4. Discussion and Conclusions
Author Contributions
Funding
Conflicts of Interest
Appendix A
Ground Truth | Lesion Type |
---|---|
Shape | Oval |
Round | |
Irregular | |
Margin | Circumscribed |
Indistinct | |
Angular | |
Microlobulated | |
Spiculated | |
Orientation | Parallel |
Not parallel | |
Echo pattern | Anechoic |
Hypoechoic | |
Complex cystic and solid | |
Isoechoic | |
Hyperechoic | |
Heterogeneous | |
Posterior features | No features |
Enhancement | |
Shadowing | |
Combined pattern |
Appendix A.1. Derivation of ρ1
Appendix A.2. The Limit of under
Appendix A.3. Derivation of ρ2
Appendix A.4. The Limit of under
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Liu, L.; Parker, K.J.; Jung, S.-H. Design and Analysis Methods for Trials with AI-Based Diagnostic Devices for Breast Cancer. J. Pers. Med. 2021, 11, 1150. https://doi.org/10.3390/jpm11111150
Liu L, Parker KJ, Jung S-H. Design and Analysis Methods for Trials with AI-Based Diagnostic Devices for Breast Cancer. Journal of Personalized Medicine. 2021; 11(11):1150. https://doi.org/10.3390/jpm11111150
Chicago/Turabian StyleLiu, Lu, Kevin J. Parker, and Sin-Ho Jung. 2021. "Design and Analysis Methods for Trials with AI-Based Diagnostic Devices for Breast Cancer" Journal of Personalized Medicine 11, no. 11: 1150. https://doi.org/10.3390/jpm11111150