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
Team-based care can go a long way toward improving patient outcomes. This review--with accompanying tips and resource lists--can help.
Subject(s)
Delivery of Health Care , Patient Care Team/organization & administration , Quality Improvement , Delivery of Health Care/methods , Delivery of Health Care/organization & administration , Humans , Models, Organizational , Needs Assessment , Outcome Assessment, Health CareABSTRACT
The concept of the patient-centered medical home (PCMH) has been widely embraced as a foundation for the transformation of health care delivery. Recent evaluations of PCMH pilots validate the initial hypothesis that care provided in the PCMH has the potential to result in better health outcomes at lower cost. However, earning recognition or certification as a PCMH can be a daunting task. This article discusses the process of developing the potential to function as a PCMH, earning formal recognition, and implementing a system of continuous quality improvement to enable the establishment of a mature, sustainable PCMH.