Effect of secular trend in drug effectiveness study in real world data

We discovered secular trend bias in a drug effectiveness study for a recently approved drug. We compared treatment outcomes between patients who received the newly approved drug and patients exposed to the standard treatment. All patients diagnosed after the new drug's approval date were considered. We built a machine learning causal inference model to determine patient subpopulations likely to respond better to the newly approved drug. After identifying the presence of secular trend bias in our data, we attempted to adjust for the bias in two different ways. First, we matched patients on the number of days from the new drug's approval date that the patient's treatment (new or standard) began. Second, we included a covariate in the model for the number of days between the date of approval of the new drug and the treatment (new or standard) start date. Neither approach completely mitigated the bias. Residual bias we attribute to differences in patient disease severity or other unmeasured patient characteristics. Had we not identified the secular trend bias in our data, the causal inference model would have been interpreted without consideration for this underlying bias. Being aware of, testing for, and handling potential bias in the data is essential to diminish the uncertainty in AI modeling.

Automatic 3D liver location and segmentation via convolutional neural networks and graph cut

Purpose Segmentation of the liver from abdominal computed tomography (CT) image is an essential step in some computer assisted clinical interventions, such as surgery planning for living donor liver transplant (LDLT), radiotherapy and volume measurement. In this work, we develop a deep learning algorithm with graph cut refinement to automatically segment liver in CT scans. Methods The proposed method consists of two main steps: (i) simultaneously liver detection and probabilistic segmentation using 3D convolutional neural networks (CNNs); (ii) accuracy refinement of initial segmentation with graph cut and the previously learned probability map. Results The proposed approach was validated on forty CT volumes taken from two public databases MICCAI-Sliver07 and 3Dircadb. For the MICCAI-Sliver07 test set, the calculated mean ratios of volumetric overlap error (VOE), relative volume difference (RVD), average symmetric surface distance (ASD), root mean square symmetric surface distance (RMSD) and maximum symmetric surface distance (MSD) are 5.9%, 2.7%, 0.91%, 1.88 mm, and 18.94 mm, respectively. In the case of 20 3Dircadb data, the calculated mean ratios of VOE, RVD, ASD, RMSD and MSD are 9.36%, 0.97%, 1.89%, 4.15 mm and 33.14 mm, respectively. Conclusion The proposed method is fully automatic without any user interaction. Quantitative results reveal that the proposed approach is efficient and accurate for hepatic volume estimation in a clinical setup. The high correlation between the automatic and manual references shows that the proposed method can be good enough to replace the time-consuming and non-reproducible manual segmentation method.