Gene Pennello

Jean Feng, Adarsh Subbaswamy, Alexej Gossmann et al.

After a machine learning (ML)-based system is deployed, monitoring its performance is important to ensure the safety and effectiveness of the algorithm over time. When an ML algorithm interacts with its environment, the algorithm can affect the data-generating mechanism and be a major source of bias when evaluating its standalone performance, an issue known as performativity. Although prior work has shown how to validate models in the presence of performativity using causal inference techniques, there has been little work on how to monitor models in the presence of performativity. Unlike the setting of model validation, there is much less agreement on which performance metrics to monitor. Different monitoring criteria impact how interpretable the resulting test statistic is, what assumptions are needed for identifiability, and the speed of detection. When this choice is further coupled with the decision to use observational versus interventional data, ML deployment teams are faced with a multitude of monitoring options. The aim of this work is to highlight the relatively under-appreciated complexity of designing a monitoring strategy and how causal reasoning can provide a systematic framework for choosing between these options. As a motivating example, we consider an ML-based risk prediction algorithm for predicting unplanned readmissions. Bringing together tools from causal inference and statistical process control, we consider six monitoring procedures (three candidate monitoring criteria and two data sources) and investigate their operating characteristics in simulation studies. Results from this case study emphasize the seemingly simple (and obvious) fact that not all monitoring systems are created equal, which has real-world impacts on the design and documentation of ML monitoring systems.

Jean Feng, Alexej Gossmann, Romain Pirracchio et al.

In a well-calibrated risk prediction model, the average predicted probability is close to the true event rate for any given subgroup. Such models are reliable across heterogeneous populations and satisfy strong notions of algorithmic fairness. However, the task of auditing a model for strong calibration is well-known to be difficult -- particularly for machine learning (ML) algorithms -- due to the sheer number of potential subgroups. As such, common practice is to only assess calibration with respect to a few predefined subgroups. Recent developments in goodness-of-fit testing offer potential solutions but are not designed for settings with weak signal or where the poorly calibrated subgroup is small, as they either overly subdivide the data or fail to divide the data at all. We introduce a new testing procedure based on the following insight: if we can reorder observations by their expected residuals, there should be a change in the association between the predicted and observed residuals along this sequence if a poorly calibrated subgroup exists. This lets us reframe the problem of calibration testing into one of changepoint detection, for which powerful methods already exist. We begin with introducing a sample-splitting procedure where a portion of the data is used to train a suite of candidate models for predicting the residual, and the remaining data are used to perform a score-based cumulative sum (CUSUM) test. To further improve power, we then extend this adaptive CUSUM test to incorporate cross-validation, while maintaining Type I error control under minimal assumptions. Compared to existing methods, the proposed procedure consistently achieved higher power in simulation studies and more than doubled the power when auditing a mortality risk prediction model.

Jean Feng, Gene Pennello, Nicholas Petrick et al.

After initial release of a machine learning algorithm, the model can be fine-tuned by retraining on subsequently gathered data, adding newly discovered features, or more. Each modification introduces a risk of deteriorating performance and must be validated on a test dataset. It may not always be practical to assemble a new dataset for testing each modification, especially when most modifications are minor or are implemented in rapid succession. Recent works have shown how one can repeatedly test modifications on the same dataset and protect against overfitting by (i) discretizing test results along a grid and (ii) applying a Bonferroni correction to adjust for the total number of modifications considered by an adaptive developer. However, the standard Bonferroni correction is overly conservative when most modifications are beneficial and/or highly correlated. This work investigates more powerful approaches using alpha-recycling and sequentially-rejective graphical procedures (SRGPs). We introduce novel extensions that account for correlation between adaptively chosen algorithmic modifications. In empirical analyses, the SRGPs control the error rate of approving unacceptable modifications and approve a substantially higher number of beneficial modifications than previous approaches.

Jean Feng, Alexej Gossmann, Gene Pennello et al.

Performance monitoring of machine learning (ML)-based risk prediction models in healthcare is complicated by the issue of confounding medical interventions (CMI): when an algorithm predicts a patient to be at high risk for an adverse event, clinicians are more likely to administer prophylactic treatment and alter the very target that the algorithm aims to predict. A simple approach is to ignore CMI and monitor only the untreated patients, whose outcomes remain unaltered. In general, ignoring CMI may inflate Type I error because (i) untreated patients disproportionally represent those with low predicted risk and (ii) evolution in both the model and clinician trust in the model can induce complex dependencies that violate standard assumptions. Nevertheless, we show that valid inference is still possible if one monitors conditional performance and if either conditional exchangeability or time-constant selection bias hold. Specifically, we develop a new score-based cumulative sum (CUSUM) monitoring procedure with dynamic control limits. Through simulations, we demonstrate the benefits of combining model updating with monitoring and investigate how over-trust in a prediction model may delay detection of performance deterioration. Finally, we illustrate how these monitoring methods can be used to detect calibration decay of an ML-based risk calculator for postoperative nausea and vomiting during the COVID-19 pandemic.

Alexis Burgon, Berkman Sahiner, Nicholas A Petrick et al.

This work addresses challenges in evaluating adaptive artificial intelligence (AI) models for medical devices, where iterative updates to both models and evaluation datasets complicate performance assessment. We introduce a novel approach with three complementary measurements: learning (model improvement on current data), potential (dataset-driven performance shifts), and retention (knowledge preservation across modification steps), to disentangle performance changes caused by model adaptations versus dynamic environments. Case studies using simulated population shifts demonstrate the approach's utility: gradual transitions enable stable learning and retention, while rapid shifts reveal trade-offs between plasticity and stability. These measurements provide practical insights for regulatory science, enabling rigorous assessment of the safety and effectiveness of adaptive AI systems over sequential modifications.