Pediatric Lyme Disease Biobank, United States, 2015-2020.
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ABSTRACT:
SUBMITTER: Nigrovic LE
PROVIDER: S-EPMC7706969 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Surveys indicate US residents spent more time outdoors in 2020 than in 2019, but fewer tick bite-related emergency department visits and Lyme disease laboratory tests were reported. Despite ongoing exposure, Lyme disease case reporting for 2020 might be artificially reduced due to coronavirus disease-associated changes in healthcare-seeking behavior.
| S-EPMC8462321 | biostudies-literature
Project description:National surveillance provides important information about Lyme disease (LD) but is subject to underreporting and variations in practice. Information is limited about the national epidemiology of LD from other sources. Retrospective analysis of a nationwide health insurance claims database identified patients from 2005-2010 with clinician-diagnosed LD using International Classification of Diseases, Ninth Revision, Clinical Modification, codes and antimicrobial drug prescriptions. Of 103,647,966 person-years, 985 inpatient admissions and 44,445 outpatient LD diagnoses were identified. Epidemiologic patterns were similar to US surveillance data overall. Outpatient incidence was highest among boys 5-9 years of age and persons of both sexes 60-64 years of age. On the basis of extrapolation to the US population and application of correction factors for coding, we estimate that annual incidence is 106.6 cases/100,000 persons and that ≈329,000 (95% credible interval 296,000-376,000) LD cases occur annually. LD is a major US public health problem that causes substantial use of health care resources.
| S-EPMC4550147 | biostudies-literature
Project description:Lyme disease (LD) is an increasing public health problem. Current laboratory testing is insensitive in early infection, the stage at which appropriate treatment is most effective in preventing disease sequelae. The Lyme Disease Biobank (LDB) collects samples from individuals with symptoms consistent with early LD presenting with or without erythema migrans (EM) or an annular, expanding skin lesion and uninfected individuals from areas of endemicity. Samples were collected from 550 participants (298 cases and 252 controls) according to institutional review board-approved protocols and shipped to a centralized biorepository. Testing was performed to confirm the presence of tick-borne pathogens by real-time PCR, and a subset of samples was tested for Borrelia burgdorferi by culture. Serology was performed on all samples using the CDC's standard two-tiered testing algorithm (STTTA) for LD. LD diagnosis was supported by laboratory testing in 82 cases, including positive results by use of the STTTA, PCR, or culture or positive results by two enzyme-linked immunosorbent assays for cases presenting with EM lesion sizes of >5?cm. The remaining 216 cases had negative laboratory testing results. For the controls, 43 were positive by at least one of the tiers and 6 were positive by use of the STTTA. The results obtained with this collection highlight and reinforce the known limitations of serologic testing in early LD, with only 29% of individuals presenting with EM lesion sizes of >5?cm yielding a positive result using the STTTA. Aliquots of whole blood, serum, and urine from clinically characterized patients with and without LD are available to investigators in academia and industry for evaluation or development of novel diagnostic assays for LD, to continue to improve upon currently available methods.
| S-EPMC7269379 | biostudies-literature
Project description:BackgroundLaboratory testing is helpful when evaluating patients with suspected Lyme disease (LD). A 2-tiered antibody testing approach is recommended, but single-tier and nonvalidated tests are also used. We conducted a survey of large commercial laboratories in the United States to assess laboratory practices. We used these data to estimate the cost of testing and number of infections among patients from whom specimens were submitted.MethodsLarge commercial laboratories were asked to report the type and volume of testing conducted nationwide in 2008, as well as the percentage of positive tests for 4 LD-endemic states. The total direct cost of testing was calculated for each test type. These data and test-specific performance parameters available in published literature were used to estimate the number of infections among source patients.ResultsSeven participating laboratories performed approximately 3.4 million LD tests on approximately 2.4 million specimens nationwide at an estimated cost of $492 million. Two-tiered testing accounted for at least 62% of assays performed; alternative testing accounted for <3% of assays. The estimated frequency of infection among patients from whom specimens were submitted ranged from 10% to 18.5%. Applied to the total numbers of specimens, this yielded an estimated 240 000 to 444 000 infected source patients in 2008.DiscussionLD testing is common and costly, with most testing in accordance with diagnostic recommendations. These results highlight the importance of considering clinical and exposure history when interpreting laboratory results for diagnostic and surveillance purposes.
| S-EPMC4646413 | biostudies-literature
Project description:Among 287 US hospitals reporting data between 2015 and 2018, annual pediatric surgical site infection (SSI) rates ranged from 0% for gallbladder to 10.4% for colon surgeries. Colon, spinal fusion, and small-bowel SSI rates did not decrease with greater surgical volumes in contrast to appendix and ventricular-shunt SSI rates.
| S-EPMC10111852 | biostudies-literature
Project description:ImportanceIncreasingly, cost-effectiveness analyses are being done to determine the value of rapidly increasing oncology drugs; however, this assumes that these analyses are unbiased.ObjectiveTo analyze the characteristics of cost-effectiveness studies and to determine characteristics associated with whether an oncology drug is found to be cost-effective.Design, setting, and participantsThis retrospective cross-sectional study included 254 cost-effectiveness analyses for 116 oncology drugs that were approved by the US Food and Drug Administration from 2015 to 2020.ExposuresEach drug was analyzed for the incremental cost-effectiveness ratio per quality-adjusted life year, the funding of the study, the authors' conflict of interest, the threshold of willingness-to-pay, from what country's perspective the analysis was done, and whether a National Institute for Health and Care Excellence cost-effectiveness analysis had been done.Main outcomes and measuresThe main outcome was the odds of a study concluding that a drug was cost-effective.ResultsThere were 116 drug approvals with 254 studies and country perspectives. Of the country perspectives, 132 (52%) were from the US. Forty-seven of 78 drugs with cost-effective studies had been shown to improve overall survival, whereas 15 of 38 of drugs without a cost-effectiveness study had been shown to improve overall survival. Having a study funded by a pharmaceutical company was associated with higher odds of a study concluding that a drug was cost-effective than studies without funding (odds ratio, 41.36; 95% CI, 11.86-262.23).Conclusions and relevanceIn this cross-sectional study, pharmaceutical funding was associated with greater odds that an oncology drug would be found to be cost-effective. These findings suggest that simply disclosing potential conflict of interest is inadequate. We encourage cost-effectiveness analyses by independent groups.
| S-EPMC8603079 | biostudies-literature
Project description:Lyme disease is the most commonly reported vector-borne illness in the United States. Lyme disease occurrence is highly seasonal and the annual springtime onset of cases is modulated by meteorological conditions in preceding months. A meteorological-based empirical model for Lyme disease onset week in the United States is driven with downscaled simulations from five global climate models and four greenhouse gas emissions scenarios to project the impacts of 21st century climate change on the annual onset week of Lyme disease. Projections are made individually and collectively for the 12 eastern States where >90% of cases occur. The national average annual onset week of Lyme disease is projected to become 0.4-0.5 weeks earlier for 2025-2040 (p<0.05), and 0.7-1.9 weeks earlier for 2065-2080 (p<0.01), with the largest shifts for scenarios with the highest greenhouse gas emissions. The more southerly mid-Atlantic States exhibit larger shifts (1.0-3.5 weeks) compared to the Northeastern and upper Midwestern States (0.2-2.3 weeks) by 2065-2080. Winter and spring temperature increases primarily cause the earlier onset. Greater spring precipitation and changes in humidity partially counteract the temperature effects. The model does not account for the possibility that abrupt shifts in the life cycle of Ixodes scapularis, the primary vector of the Lyme disease spirochete Borrelia burgdorferi in the eastern United States, may alter the disease transmission cycle in unforeseen ways. The results suggest 21st century climate change will make environmental conditions suitable for earlier annual onset of Lyme disease cases in the United States with possible implications for the timing of public health interventions.
| S-EPMC4631020 | biostudies-literature
Project description:Importance:The incidence and geographic range of Lyme disease continues to increase in the United States because of the expansion of Ixodes scapularis, the species of tick that is the main Lyme disease vector. Currently, no dynamic model for the disease spread exists that integrates information of both acarological and human case surveillance data. Objective:To characterize the spatiotemporal spread of Lyme disease in humans among counties in US endemic regions. Design, Setting, and Participants:This cross-sectional study modeled the spread of Lyme disease county-level case reporting, accounting for county-level demographic factors, environmental factors associated with tick presence and human exposure, and the spatiotemporal association between counties. The analyses were conducted between January and August 2019. The setting was 1405 counties in the following regions of the United States: West North Central, East North Central, New England, Middle Atlantic, and the South. Assessments were based on publicly available Lyme disease case data reported to the US Centers for Disease Control and Prevention (CDC) between January 2000 and December 2017. Main Outcomes and Measures:Probability of reporting the first case of Lyme disease by county by year. Results:Between 2000 and 2017, a total of 497?569 Lyme disease cases were reported to the CDC in the study area. Reporting a first case of Lyme disease was associated with a county's and county's neighbors' forest coverage, elevation, percentage of population living in the wildland-urban interface, tick presence, county's population size, proportion of neighbors reporting cases, and neighbors' years since first reporting. The model that included these variables showed high predictive power, with a mean area under the receiver operating characteristic curve of 81.1 (95% CI, 68.5-86.2). The model predicted the first reported Lyme disease case a mean (SD) of 5.5 (3.5) years earlier than was reported to the CDC, with a mean spread velocity estimated at 27.4 (95% CI, 13.6-54.4) km per year. Among 162 counties without reported cases, 47 (29.0%) had a high probability of reporting Lyme disease by 2018. The estimated mean time lag between the first reported case in a neighboring county and any county was 7 (95% CI, 3-8) years. Conclusions and Relevance:This study's findings suggest that, if updated regularly and expanded geographically, this predictive model could enable states and counties to develop more specific Lyme disease prevention and control plans, including improved sensitization of the general population and medical community.
| S-EPMC7054839 | biostudies-literature
Project description:Approximately 476,000 cases of Lyme disease are diagnosed in the United States annually, yet comprehensive economic evaluations are lacking. In a prospective study among reported cases in Lyme disease-endemic states, we estimated the total patient cost and total societal cost of the disease. In addition, we evaluated disease and demographic factors associated with total societal cost. Participants had a mean patient cost of ≈$1,200 (median $240) and a mean societal cost of ≈$2,000 (median $700). Patients with confirmed disseminated disease or probable disease had approximately double the societal cost of those with confirmed localized disease. The annual, aggregate cost of diagnosed Lyme disease could be $345-968 million (2016 US dollars) to US society. Our findings emphasize the importance of effective prevention and early diagnosis to reduce illness and associated costs. These results can be used in cost-effectiveness analyses of current and future prevention methods, such as a vaccine.
| S-EPMC9155891 | biostudies-literature
Project description: Not available
| S-EPMC4918180 | biostudies-literature