ABSTRACT
BACKGROUND: Background incidence rates (IRs) of health outcomes in Lyme disease endemic regions are useful to contextualize events reported during Lyme disease vaccine clinical trials or post-marketing. The objective of this study was to estimate and compare IRs of health outcomes in Lyme disease endemic versus non-endemic regions in the US during pre-COVID and COVID era timeframes. METHODS: IQVIA PharMetrics® Plus commercial claims database was used to estimate IRs of 64 outcomes relevant to vaccine safety monitoring in the US during January 1, 2017-December 31, 2019 and January 1, 2020-December 31, 2021. Analyses included all individuals aged ≥ 2 years with ≥ 1 year of continuous enrollment. Outcomes were defined by International Classification of Diseases Clinical Modification, 10th Revision (ICD-10-CM) diagnosis codes. IRs and 95 % confidence intervals (CIs) were calculated for each outcome and compared between endemic vs. non-endemic regions, and pre-COVID vs. COVID era using IR ratios (IRR). RESULTS: The study population included 8.7 million (M) in endemic and 27.8 M in non-endemic regions. Mean age and sex were similar in endemic and non-endemic regions. In both study periods, the IRs were statistically higher in endemic regions for anaphylaxis, meningoencephalitis, myocarditis/pericarditis, and rash (including erythema migrans) as compared with non-endemic regions. Conversely, significantly lower IRs were observed in endemic regions for acute kidney injury, disseminated intravascular coagulation, heart failure, myelitis, myopathies, and systemic lupus erythematosus in both study periods. Most outcomes were statistically less frequent during the COVID-era. CONCLUSION: This study identified potential differences between Lyme endemic and non-endemic regions of the US in background IRs of health conditions during pre-COVID and COVID era timeframes to inform Lyme disease vaccine safety monitoring. These regional and temporal differences in background IRs should be considered when contextualizing possible safety signals in clinical trials and post-marketing of a vaccine targeted at Lyme disease prevention.
Subject(s)
Lyme Disease Vaccines , Lyme Disease , Humans , Incidence , Lyme Disease/epidemiology , Risk Factors , Outcome Assessment, Health CareABSTRACT
OBJECTIVES: To assess crash risk and driving habits associated with chronic medical conditions among drivers entering old age. DESIGN: Prospective cohort study. SETTING: French cohort GAZEL. PARTICIPANTS: 12 460 drivers in the analysis of road traffic crash, among whom 11 670 completed the follow-up period (2007-2014). We assessed driving cessation among 11 633 participants over the same period, and mileage and driving avoidance among the 4973 participants who returned a road safety questionnaire in 2015. MAIN OUTCOME MEASURES: Yearly occurrence of at least one road crash as a driver; time to driving cessation; mileage; driving avoidance: at night, with bad weather, in heavy traffic, with glare conditions, over long distances. RESULTS: Several potentially risky conditions (angina, myocardial infarction, coronary disease; stroke; nephritic colic, urinary stones; glaucoma) were associated with lower mileage and/or driving avoidance and did not increase crash risk. Neither driving avoidance nor lower mileage was found for other conditions associated with an increased crash risk: hearing difficulties (adjusted OR 1.19, 95% CI 1.06 to 1.34); joint disorders (1.17, 95% CI 1.06 to 1.30). Depression, anxiety and stress was associated with an increased crash risk (1.23, 95% CI 1.01 to 1.49) despite increased driving avoidance. Parkinson's disease was associated with driving cessation (adjusted HR 32.61, 95% CI 14.21 to 65.17). CONCLUSIONS: Depending on their condition, and probably on the associated risk perception, drivers entering old age report diverse driving habits. For example, hearing difficulties is a frequent condition, rarely considered a threat to road safety, and nonetheless associated with an increased crash risk.