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Purpose: Perinatal epidemiology studies using healthcare utilization databases are often restricted to live births, largely due to the lack of established algorithms to identify non‐live births. The study objective was to develop and validate claims‐based algorithms for the ascertainment of non‐live births. Methods: Using the Mass General Brigham Research Patient Data Registry 2000–2014, we assembled a cohort of women enrolled in Medicaid with a non‐live birth. Based on ≥1 inpatient or ≥2 outpatient diagnosis/procedure codes, we identified and randomly sampled 100 potential stillbirth, spontaneous abortion, and termination cases each. For the secondary definitions, we excluded cases with codes for other pregnancy outcomes within ±5 days of the outcome of interest and relaxed the definitions for spontaneous abortion and termination by allowing cases with one outpatient diagnosis only. Cases were adjudicated based on medical chart review. We estimated the positive predictive value (PPV) for each outcome. Results: The PPV was 71.0% (95% CI, 61.1–79.6) for stillbirth; 79.0% (69.7–86.5) for spontaneous abortion, and 93.0% (86.1–97.1) for termination. When excluding cases with adjacent codes for other pregnancy outcomes and further relaxing the definition, the PPV increased to 80.6% (69.5–88.9) for stillbirth, 86.6% (80.5–91.3) for spontaneous abortion and 94.9% (91.1–97.4) for termination. The PPV for the composite outcome using the relaxed definition was 94.4% (92.3–96.1). Conclusions: Our findings suggest non‐live birth outcomes can be identified in a valid manner in epidemiological studies based on healthcare utilization databases. [ABSTRACT FROM AUTHOR]

Objective: To estimate real-world off-label use of sodium-glucose cotransporter 2 (SGLT2) inhibitors in patients with type 1 diabetes, estimate rates of diabetic ketoacidosis (DKA), and compare them with DKA rates observed in sotagliflozin clinical trials.Research Design and Methods: We identified initiators of SGLT2 inhibitors in the Sentinel System from March 2013 to June 2018, determined the prevalence of type 1 diabetes using a narrow and a broad definition, and measured rates of DKA using administrative claims data. Standardized incidence ratios (SIRs) were calculated using age- and sex-specific follow-up time in Sentinel and age- and sex-specific DKA rates from sotagliflozin trials 309, 310, and 312.Results: Among 475,527 initiators of SGLT2 inhibitors, 0.50% and 0.92% met narrow and broad criteria for type 1 diabetes, respectively. Rates of DKA in the narrow and broad groups were 7.3/100 person-years and 4.5/100 person-years, respectively. Among patients who met narrow criteria for type 1 diabetes, rates of DKA were highest for patients aged 25-44 years, especially females aged 25-44 years (19.7/100 person-years). More DKA events were observed during off-label use of SGLT2 inhibitors in Sentinel than would be expected based on sotagliflozin clinical trials (SIR = 1.83; 95% CI 1.45-2.28).Conclusions: Real-world off-label use of SGLT2 inhibitors among patients with type 1 diabetes accounted for a small proportion of overall SGLT2 inhibitor use. However, the risk for DKA during off-label use was notable, especially among young, female patients. Although real-word rates of DKA exceeded the expectation based on clinical trials, results should be interpreted with caution due to differences in study methods, patient samples, and study drugs. [ABSTRACT FROM AUTHOR]

To study the risk of spontaneous abortion (SAB) or termination using healthcare utilization databases, algorithms to estimate the gestational age (GA) are needed. Using Medicaid data, we developed a hierarchical algorithm to classify pregnancy outcomes. We identified the subset of potential SAB and termination cases, and abstracted the GA from linked electronic medical records (gold standard). We developed three approaches: (1) assign median GA for SAB and termination cases in the US; (2) draw a random GA from the population distributions; (3) estimate GA based on regression models. Algorithm performance was assessed based on the proportion of pregnancies with estimated GA within 1-4 weeks of the gold standard, the mean squared error (MSE) and the R-squared. Approach 1 and Approach 3 had similar performance, though approach 3 using random forest models with variables selected via the Boruta algorithm had better MSE and R-squared. For SAB, 58.0% of pregnancies were correctly classified within 2 weeks of the gold standard (MSE: 8.7, R-squared: 0.09). For termination, the proportions were 66.3% (MSE: 11.7; R-squared: 0.35). SABs and terminations can be studied in healthcare utilization data with careful implementation of validated algorithms though higher level of GA misclassification is expected compared to live births., (© The Author(s) 2024. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Introduction: Vision problems have become an increasingly important health and safety concern for pilots due to the aging of the pilot population. This paper examines the incidence of age-related vision problems in a birth cohort of commuter air carrier and air taxi pilots., Methods: A cohort of 3019 male pilots ages 45-54 yr at baseline and holding Class I medical certificates in 1987 were retrospectively studied from 1987 to 1997 through the medical certification system of the Federal Aviation Administration. Poisson regression modeling based on generalized estimation equations was used to assess the associations of pilot characteristics with risk of developing vision problems., Results: The study period accumulated 419 incident cases of vision problems, yielding an incidence of 20.3 per 1000 person-years. For pilots ages 45-49, 50-54, 55-59, and 60-64, the incidence of vision problems was 17, 20, 24, and 39 per 1000 person-years, respectively. A baseline history of eye problems and older age were each significantly associated with an increased incidence of vision problems. The adjusted relative risks of vision problems for pilot age were 1.0 (45-49 yr), 1.2 (50-54 yr), 1.4 (55-59 yr), and 3.0 (60-64 yr). The three most prevalent types of visual problems were corneal problems (16%), glaucoma (15%), and cataracts (7%)., Conclusion: Identifying and preventing pathological changes that alter visual performance among pilots is an important component of aviation safety. With the increasing maturity of the pilot population, it is essential that appropriate visual screening and correction be emphasized for specific age-related ophthalmic conditions.

Introduction: Mandatory alcohol testing has been implemented in the U.S. aviation industry since 1995. This study documents the prevalence of alcohol violations and the association between alcohol violations and aviation accidents among aviation employees with safety-sensitive functions., Methods: Data from the random alcohol testing and post-accident alcohol testing programs reported by major airlines to the Federal Aviation Administration for the years 1995 through 2002 were analyzed. A violation was defined as an alcohol level of > or = 0.04% or a refusal to submit to testing. Relative and attributable risks of accident involvement associated with alcohol violations were estimated using the case-control method., Results: During the study period, random alcohol testing yielded a total of 440 violations, with an overall prevalence rate of 0.09% and a prevalence rate of 0.03% for flight crews. Alcohol violations were associated with an increased yet not statistically significant risk of accident involvement (odds ratio 2.56, 95% confidence interval 0.81-7.08) and were attributed to 0.13% of aviation accidents., Discussion: Alcohol violations among U.S. major airline employees with safety-sensitive functions are rare and play a negligible role in aviation accidents.