Background Maternal hemorrhage protocols involve risk screening. These protocols prepare clinicians for potential hemorrhage and transfusion in individual patients. Patient‐specific estimation and stratification of risk may improve maternal outcomes. Study Design and Methods Prediction models for hemorrhage and transfusion were trained and tested in a data set of 74 variables from 63 973 deliveries (97.6% of the source population of 65 560 deliveries included in a perinatal database from an academic urban delivery center) with sufficient data at pertinent time points: antepartum, peripartum, and postpartum. Hemorrhage and transfusion were present in 6% and 1.6% of deliveries, respectively. Model performance was evaluated with the receiver operating characteristic (ROC), precision‐recall curves, and the Hosmer‐Lemeshow calibration statistic. Results For hemorrhage risk prediction, logistic regression model discrimination showed ROCs of 0.633, 0.643, and 0.661 for the antepartum, peripartum, and postpartum models, respectively. These improve upon the California Maternal Quality Care Collaborative (CMQCC) accuracy of 0.613 for hemorrhage. Predictions of transfusion resulted in ROCs of 0.806, 0.822, and 0.854 for the antepartum, peripartum, and postpartum models, respectively. Previously described and new risk factors were identified. Models were not well calibrated with Hosmer‐Lemeshow statistic P values between .001 and .6. Conclusions Our models improve on existing risk assessment; however, further enhancement might require the inclusion of more granular, dynamic data. With the goal of increasing translatability, this work was distilled to an online open‐source repository, including a form allowing risk factor inputs and outputs of CMQCC risk, alongside our numerical risk estimation and stratification of hemorrhage and transfusion.
BACKGROUND Modeling approaches offer a novel way to detect and predict coagulopathy in trauma patients. A dynamic model, built and tested on thromboelastogram (TEG) data, was used to generate a virtual library of over 160,000 simulated RapidTEGs. The patient-specific parameters are the initial platelet count, platelet activation rate, thrombus growth rate, and lysis rate (P(0), k1, k2, and k3, respectively). METHODS Patient data from both STAAMP (n = 182 patients) and PAMPer (n = 111 patients) clinical trials were collected. A total of 873 RapidTEGs were analyzed. One hundred sixteen TEGs indicated maximum amplitude (MA) below normal and 466 TEGs indicated lysis percent above normal. Each patient's TEG response was compared against the virtual library of TEGs to determine library trajectories having the least sum-of-squared error versus the patient TEG up to each specified evaluation time ∈ (3, 4, 5, 7.5, 10, 15, 20 minutes). Using 10 nearest-neighbor trajectories, a logistic regression was performed to predict if the patient TEG indicated MA below normal (<50 mm), lysis percent 30 minutes after MA (LY30) greater than 3%, and/or blood transfusion need using the parameters from the dynamic model. RESULTS The algorithm predicts abnormal MA values using the initial 3 minutes of RapidTEG data with a median area under the curve of 0.95, and improves with more data to 0.98 by 10 minutes. Prediction of future platelet and packed red blood cell transfusion based on parameters at 4 and 5 minutes, respectively, provides equivalent predictions to the traditional TEG parameters in significantly less time. Dynamic model parameters could not predict abnormal LY30 or future fresh-frozen plasma transfusion. CONCLUSION This analysis could be incorporated into TEG software and workflow to quickly estimate if the MA would be below or above threshold value within the initial minutes following a TEG, along with an estimate of what blood products to have on hand. LEVEL OF EVIDENCE Therapeutic/Care Management: Level IV.
Hormonal contraceptives are a widely used class of drugs throughout the world. The clearance of the progestin component of oral combined hormonal contraceptives are mediated by CYP3A4, thus there is risk for drug-drug interactions (DDIs) when given concomitantly with CYP3A4 perpetrators. WHAT QUESTION DID THIS STUDY ADDRESS? What is the CYP3A4 DDI extent of a high fm CYP3A4 progestin, drospirenone, and how does this compare to a relatively low fm CYP3A4 progestin, levonorgestrel?WHAT DOES THIS STUDY ADD TO OUR KNOWLEDGE? By understanding the pharmacokinetic alteration risk of high and low fm CYP3A4 progestins in DDI scenarios, a broad understanding of progestin-based DDI risk is elucidated due to this within-class bracketing approach. HOW MIGHT THIS CHANGE CLINICAL PHARMA-COLOGY OR TRANSLATIONAL SCIENCE? Applications of this work's results can provide a deeper perspective on how to mitigate contraceptive DDI risks and optimize future product development.
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