Which Data Analytics Tool Should We Use to Evaluate Risk in Upstream Drug Supply Chains?

Drug shortages are a persistent and serious problem in the United States, affecting patient care and health care costs. This article canvasses factors that contribute to drug shortages, such as manufacturing complexity, price, and quality inspection records. This article further proposes an early warning system and payment, contracting, and pricing innovations to mitigate drug shortages and offers data-driven recommendations to stakeholders looking to protect the supply of quality medicines.

Combined Symptom Screening and At-Home Tests for COVID-19.

BACKGROUND AND OBJECTIVE: At-home rapid antigen tests provide a convenient and expedited resource to learn about severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection status. However, low sensitivity of at-home antigen tests presents a challenge. This study examines the accuracy of at-home tests, when combined with computer-facilitated symptom screening. METHODS: The study used primary data sources with data collected during 2 phases at different periods (phase 1 and phase 2): one during the period in which the alpha variant of SARS-CoV-2 was predominant in the United States and another during the surge of the delta variant. Four hundred sixty-one study participants were included in the analyses from phase 1 and 374 subjects from phase 2. Phase 1 data were used to develop a computerized symptom screening tool, using ordinary logistic regression with interaction terms, which predicted coronavirus disease-2019 (COVID-19) reverse transcription polymerase chain reaction (RT-PCR) test results. Phase 2 data were used to validate the accuracy of predicting COVID-19 diagnosis with (1) computerized symptom screening; (2) at-home rapid antigen testing; (3) the combination of both screening methods; and (4) the combination of symptom screening and vaccination status. The McFadden pseudo-R2 was used as a measure of percentage of variation in RT-PCR test results explained by the various screening methods. RESULTS: The McFadden pseudo-R2 for the first at-home test, the second at-home test, and computerized symptom screening was 0.274, 0.140, and 0.158, respectively. Scores between 0.2 and 0.4 indicated moderate levels of accuracy. The first at-home test had low sensitivity (0.587) and high specificity (0.989). Adding a second at-home test did not improve the sensitivity of the first test. Computerized symptom screening improved the accuracy of the first at-home test (added 0.131 points to sensitivity and 6.9% to pseudo-R2 of the first at-home test). Computerized symptom screening and vaccination status was the most accurate method to screen patients for COVID-19 or an active infection with SARS-CoV-2 in the community (pseudo-R2 = 0.476). CONCLUSION: Computerized symptom screening could either improve, or in some situations, replace at-home antigen tests for those individuals experiencing COVID-19 symptoms.

Order of Occurrence of COVID-19 Symptoms.

BACKGROUND AND OBJECTIVES: COVID-19 symptoms change after onset-some show early, others later. This article examines whether the order of occurrence of symptoms can improve diagnosis of COVID-19 before test results are available. METHODS: In total, 483 individuals who completed a COVID-19 test were recruited through Listservs. Participants then completed an online survey regarding their symptoms and test results. The order of symptoms was set according to (a) whether the participant had a "history of the symptom" due to a prior condition; and (b) whether the symptom "occurred first," or prior to, other symptoms of COVID-19. Two LASSO (Least Absolute Shrinkage and Selection Operator) regression models were developed. The first model, referred to as "time-invariant," used demographics and symptoms but not the order of symptom occurrence. The second model, referred to as "time-sensitive," used the same data set but included the order of symptom occurrence. RESULTS: The average cross-validated area under the receiver operating characteristic (AROC) curve for the time-invariant model was 0.784. The time-sensitive model had an AROC curve of 0.799. The difference between the 2 accuracy levels was statistically significant (α < .05). CONCLUSION: The order of symptom occurrence made a statistically significant, but small, improvement in the accuracy of the diagnosis of COVID-19.

The Role of Symptom Clusters in Triage of COVID-19 Patients.

BACKGROUND AND OBJECTIVE: COVID-19 manifests with a broad range of symptoms. This study investigates whether clusters of respiratory, gastrointestinal, or neurological symptoms can be used to diagnose COVID-19. METHODS: We surveyed symptoms of 483 subjects who had completed COVID-19 laboratory tests in the last 30 days. The survey collected data on demographic characteristics, self-reported symptoms for different types of infections within 14 days of onset of illness, and self-reported COVID-19 test results. Robust LASSO regression was used to create 3 nested models. In all 3 models, the response variable was the COVID-19 test result. In the first model, referred to as the "main effect model," the independent variables were demographic characteristics, history of chronic symptoms, and current symptoms. The second model, referred to as the "hierarchical clustering model," added clusters of variables to the list of independent variables. These clusters were established through hierarchical clustering. The third model, referred to as the "interaction-terms model," also added clusters of variables to the list of independent variables; this time clusters were established through pairwise and triple-way interaction terms. Models were constructed on a randomly selected 80% of the data and accuracy was cross-validated on the remaining 20% of the data. The process was bootstrapped 30 times. Accuracy of the 3 models was measured using the average of the cross-validated area under the receiver operating characteristic curves (AUROCs). RESULTS: In 30 bootstrap samples, the main effect model had an AUROC of 0.78. The hierarchical clustering model had an AUROC of 0.80. The interaction-terms model had an AUROC of 0.81. Both the hierarchical cluster model and the interaction model were significantly different from the main effect model (α = .04). Patients with different races/ethnicities, genders, and ages presented with different symptom clusters. CONCLUSIONS: Using clusters of symptoms, it is possible to more accurately diagnose COVID-19 among symptomatic patients.