Why Almost All Ml Models For Medicine Are Wrong And What We Need For Evidence Based Medical Ai
Why almost all ML models for medicine are wrong-and what we need for evidence-based medical AI
Terms
Concerns
- many of the models being published are not validated/verified well and do not perform as stated
- This is based on many assumptions in the design process for these models
Issues with model training:
- Unreliable ground truths
- inappropriate decision thresholds
- assessment metrics are inadequate
- validation datasets do not represent real world use cases
Ground Truth Concerns
Specifically in medicine, diagnostic categories are not cut and dry categories and there is often blurring/overlap. However ML training assumptions are being made that the labels used are objective and accurate/correct, and then used for predictions. These assumptions on accuracy supremacy lead to noise in the dataset and impact the application of the model.
Threshold optimization
Most ML models optimize global metrics such as AUROC, assuming all decision thresholds are equally important. In medicine this assumption is incorrect:
- different diseases have different acceptable false positive / false negative tradeoffs
- decision thresholds depend on clinical context and risk
- threshold selection therefore has ethical and clinical implications
Assessment metrics
Many commonly reported metrics are unstable or misleading. Problems:
- accuracy is inflated by class imbalance
- PPV changes with disease prevalence
- F1, MCC, sensitivity and specificity depend on the chosen threshold
- many papers report metrics using an arbitrary threshold of 0.5 Thus recommendations include:
- report calibration
- report clinical utility (net benefit)
- evaluate robustness on heterogeneous and out-of-distribution (OOD) data
- evaluate performance across clinically relevant thresholds
Calibration
A model should produce probabilities that match real-world outcomes. For example:
- if the model predicts 80% probability for 100 patients, then roughly 80 should actually have the condition. Calibration should be evaluated around clinically important decision thresholds, not only globally.
Performance uncertainty
Many papers report only point estimates for metrics. The problem is(are):
- evaluation datasets are often small
- performance estimates have statistical uncertainty
- small differences between models may not be meaningful To address these concerns, researchers can use report confidence/credible intervals and use statistical tests when comparing models
External validation
Many studies only evaluate on held-out splits from the same dataset. But this does not show whether the model generalizes
External validation should use:
- independent hospitals
- different populations
- different collection conditions
- ideally prospective datasets
Temporal validation
Clinical data changes over time:
- disease prevalence
- diagnostic criteria
- laboratory equipment
- clinical practice
- patient populations Models should therefore include:
- temporal validation
- recalibration
- post-deployment monitoring
- MLOps fo continuous evaluation
Recommendations: Real-world data
The paper argues that real-world clinical data is inherently noisy. Rather than assuming perfect labels, ML methods should support:
- noisy labels
- soft/probabilistic labels
- annotator disagreement
- dataset shift
- uncertainty estimation
- OOD detection
- robust learning