Disparities with influenza vaccine use in long-term survivors of metastatic breast cancer.

PURPOSE: Elderly women diagnosed with metastatic breast cancer (MBC) are living longer, however their primary care management may be sub-optimal. Influenza results in preventable hospitalizations and deaths. Guidelines recommend the influenza vaccine for those > 65 years and those with cancer but use is unknown. METHODS: A retrospective analysis was conducted using the Surveillance, Epidemiology, and End Results (SEER)-Medicare linked data. Patients were included if they were diagnosed with MBC from 1/1/2008-12/31/2017 and were ≥ 65 years of age. The primary outcome was influenza vaccine use among patients surviving ≥ 3-years. We conducted multivariable analyses using demographic and clinical factors to identify associations with vaccine use. We compared utilization to cancer-free controls. RESULTS: We identified 1,970 patients with MBC that survived for ≥ 3 years. The median age at diagnosis was 73 years. Furthermore, 1,742 (88%) patients were White, and 153 (8%) patients were Black. Only 1,264 (64%) received an influenza vaccine at least one time and 51% received the vaccine at least two times. A multivariable model found lower odds of vaccine receipt for Black patients (OR = 0.48; 95% CI 0.34-0.68, p < 0.001) and higher odds for patients that saw primary care in the year prior to diagnosis (OR = 1.91, 95% CI 1.57-2.33, p < 0.001). Patients with MBC had lower odds of vaccine use compared to cancer free controls (OR = 0.85, 95% CI 0.74-0.97, p < 0.001). CONCLUSION: Over 1/3 of long-term MBC survivors in our cohort did not receive the influenza vaccine. Black patients are about half as likely to be vaccinated. Given the known benefit of the vaccine, improving uptake could be an important strategy to improve outcomes.

Randomized adaptive selection trial of cryotherapy, compression therapy, and placebo to prevent taxane-induced peripheral neuropathy in patients with breast cancer.

BACKGROUND: Chemotherapy-induced peripheral neuropathy (CIPN) is a common and debilitating adverse effect of taxane therapy. Small non-randomized studies in patients with early-stage breast cancer (ESBC) suggest both cryotherapy and compression therapy may prevent CIPN. It is unknown which is more effective. METHODS: We conducted a randomized phase IIB adaptive sequential selection trial of cryotherapy vs. compression therapy vs. placebo ("loose" gloves/socks) during taxane chemotherapy. Participants were randomized in triplets. Garments were worn for 90-120 min, beginning 15 min prior and continuing for 15 min following the infusion. The primary goal was to select the best intervention based on a Levin-Robbins-Leu sequential selection procedure. The primary endpoint was a < 5-point decrease in the Functional Assessment of Cancer Therapy Neurotoxicity (FACT-NTX) at 12 weeks. An arm was eliminated if it had four or more fewer successes than the currently leading arm. Secondary endpoints included intervention adherence and patient-reported comfort/satisfaction. RESULTS: Between April 2019 and April 2021, 63 patients were randomized (cryotherapy (20); compression (22); placebo (21)). Most patients (60.3%) were treated with docetaxel. The stopping criterion was met after the 17th triplet (n = 51) was evaluated; success at 12 weeks occurred in 11 (64.7%) on compression therapy, 7 (41.1%) on cryotherapy, and 7 (41.1%) on placebo. Adherence to the intervention was lowest with cryotherapy (35.0%) compared to compression (72.7%) and placebo (76.2%). CONCLUSION: Compression therapy was the most effective intervention in this phase IIB selection trial to prevent CIPN and was well tolerated. Compression therapy for the prevention of CIPN should be evaluated in a phase III study. CLINICAL TRIAL REGISTRATION: ClinicaTrials.gov Identifier: NCT03873272.

Association Between Copayment Assistance, Insurance Type, Prior Authorization, and Time to Receipt of Oral Anticancer Drugs.

PURPOSE: Oral anticancer drugs (OACDs) have become increasingly prevalent over the past decade. OACD prescriptions require coordination between payers and providers, which can delay drug receipt. We examined the association between insurance type, pursuit of copayment assistance, pursuit of prior authorization (PA), and time to receipt (TTR) for new OACD prescriptions. METHODS: We prospectively collected data on new OACD prescriptions for adult oncology patients from January 1, 2018, to December 31, 2019, including demographic and clinical characteristics, insurance type, and pursuit of PA and copayment assistance. TTR was defined as the number of days from prescription to OACD receipt. We summarized TTR using cumulative incidence and compared TTR by insurance type, pursuit of copayment assistance, and PA activity using the log-rank test. RESULTS: Our cohort of 1,024 patients was 53% male, and 40% were younger than 65. Twenty-six percent had commercial insurance only, 16% had Medicaid only, and 59% had Medicare with or without additional insurance. Eighty-six percent of prescriptions were successfully received. Across all prescriptions, 69% involved PA activity, and 21% involved the copayment assistance process. In unadjusted analyses, prescriptions involving the copayment assistance process had longer TTR compared with those not involving assistance (log-rank P value = .005) and OACDs covered by Medicare/commercial insurance had a longer TTR compared with Medicaid (log-rank P value = .006). The PA process was not associated with TTR (log-rank P value = .124). CONCLUSION: The process for obtaining OACDs is complex. The copayment assistance process and Medicare/commercial insurance are associated with delayed TTR. New policies are needed to reduce time to OACD receipt.

A Brief Screening Tool for Assessment of Financial Toxicity.

OBJECTIVES: To explore the utility of brief financial screening items to facilitate the implementation of routine financial toxicity screening. SAMPLE & SETTING: 50 women with breast cancer completed a one-time survey that included the Comprehensive Score for Financial Toxicity (COST): A FACIT Measure of Financial Toxicity, a visual analog scale, and a brief sociodemographic questionnaire. METHODS & VARIABLES: Survey responses were examined to assess the psychometric properties of individual COST items and the visual analog scale by calculating Cronbach's alpha and Pearson's correlation coefficients. RESULTS: The mean COST was 21.4, and 27 respondents met criteria for financial toxicity (a COST lower than 22). As expected, all items correlated strongly to the overall COST, but four items (items 3, 6, 8, and 10) performed strongest (r > 0.8). IMPLICATIONS FOR NURSING: This study provides evidence for individual COST items to be used as brief screening items. Future research should test the utility of these items in larger sample sizes with a more diverse representation of patients by age, race, ethnicity, and tumor type and stage.

Implementation of Systematic Financial Screening in an Outpatient Breast Oncology Setting.

PURPOSE: Implementation of routine financial screening is a critical step toward mitigating financial toxicity. We evaluated the feasibility, sustainability, and acceptability of systematic financial screening in the outpatient breast oncology clinic at a large, urban cancer center. METHODS: We developed and implemented a stakeholder-informed process to systematically screen for financial hardship and worry. A 2-item assessment in English or Spanish was administered to patients through the electronic medical record portal or using paper forms. We evaluated completion rates and mode of completion. Through feedback from patients, clinicians, and staff, we identified strategies to improve completion rates and acceptability. RESULTS: From March, 2021, to February, 2022, 3,500 patients were seen in the breast oncology clinic. Of them, 39% (n = 1,349) responded to the screening items, either by paper or portal, 12% (n = 437) preferred not to answer, and the remaining 49% (n = 1,714) did not have data in their electronic health record, meaning they were not offered screening or did not complete the paper forms. Young adults (18-39 years) were more likely to respond compared with patients 70 years or older (61% v 30%, P < .01). English-preferring patients were more likely to complete the screening compared with those who preferred Spanish (46% v 28%, P < .01). Non-Hispanic White patients were more likely to respond compared with Non-Hispanic Black patients and with Hispanic patients (46% v 39% v 32%, P < .01). Strategies to improve completion rates included partnering with staff to facilitate paper form administration, optimizing patient engagement with the portal, and clearly communicating the purpose of the screening. CONCLUSION: Systematic financial screening is feasible, and electronic data capture facilitates successful implementation. However, inclusive procedures that address language and technology preferences are needed to optimize screening.

Epitope-Specific IgE at 1 Year of Age Can Predict Peanut Allergy Status at 5 Years.

BACKGROUND: Currently, there is no laboratory test that can accurately identify children at risk of developing peanut allergy. Utilizing a subset of children randomized to the peanut avoidance arm of the LEAP trial, we monitored the development of epitope-specific (ses-)IgE and ses-IgG4 from 4-11 months to 5 years of age. OBJECTIVE: The aim of the study was to evaluate the prognostic ability of epitope-specific antibodies to predict the result of an oral food challenge (OFC) at 5 years. METHODS: A Bead-Based Epitope Assay was used to quantitate IgE and IgG4 to 64 sequential (linear) epitopes from Ara h 1-3 proteins at 4-11 months, 1 and 2.5 years of age in 74 subjects (38 of them with a positive OFC at 5 years). Specific IgE (sIgE) to peanut and component proteins was measured using ImmunoCAP. Machine learning methods were used to identify the earliest time point to predict 5-year outcome, developing prognostic algorithms based only on 4-11 month samples, 1-year or 2.5-year, and a combination of them. Data from 74 children were iteratively split 3:1 into training and validation sets, and machine learning models were developed to predict the 5-year outcome. A test set (n = 90) from an independent cohort was used for final evaluation. RESULTS: Elastic-Net algorithm combining ses-IgE and IgE to Ara h 1, 2, 3, and 9 proteins could predict the 5-year peanut allergy status of LEAP participants with an average validation accuracy of 64% at baseline. Samples taken at 1 year accurately predicted a 5-year OFC outcome with 83% accuracy. This performance remained consistent when evaluated on an independent CoFAR2 cohort with an accuracy of 78% for the 1-year model. CONCLUSION: IgE antibody profiles at 1 year of age are predictive of peanut OFC at 5 years in children avoiding peanuts. If further confirmed, this model may enable early identification of infants who may benefit from early immunotherapeutic interventions.

Impact of a Hospital-Based Specialty Pharmacy in Partnership With a Care Coordination Organization on Time to Delivery and Receipt of Oral Anticancer Drugs.

PURPOSE: Oral anticancer drug (OACD) prescriptions require extensive coordination between providers and payers, which can delay drug receipt. Specialty pharmacies facilitate communication between multiple entities. In 2018, our cancer center partnered with a freestanding organization to implement a hospital-based specialty pharmacy (HB-SP). We evaluated the time to drug receipt (TTR) before and after HB-SP implementation. METHODS: Data were prospectively collected on all new OACD prescriptions for adult oncology patients from January 1, 2018, to December 31, 2019. In fall 2018, a HB-SP was initiated. We collected patient sociodemographic, clinical, and prescription data. TTR was the number of days from OACD prescription to drug receipt. We used multivariable logistic regression to examine factors associated with TTR ≤ 7 days before and after HB-SP implementation. RESULTS: In total, 954 patients were included, representing 1,102 new OACDs. The majority of prescribed drugs were targeted OACDs (56%, n = 617), and 71% (n = 779) required prior authorization. Of all prescriptions, 84% (n = 960) were successfully received with an overall median TTR of 7 days. In unadjusted analysis, HB-SP implementation, drug class, race and ethnicity, and prior authorization requirement were significantly associated with TTR. Adjusted analyses found that patients were more likely to receive their drugs ≤ 7 days after HB-SP implementation (53% v 47%; adjusted odds ratio [aOR], 1.29; 95% CI, 1.00 to 1.68; P = .05). CONCLUSION: The implementation of a HB-SP in partnership with a collaborative care model contributed to a decrease in TTR for OACDs. This difference is in part attributable to improved care coordination and communication. A centralized approach may improve overall efficiency due to fewer practice disruptions.

Factors Associated With Patients Not Receiving Oral Anticancer Drugs.

Importance: Oral anticancer drugs (OACDs) are increasingly prescribed for cancer treatment and require significant coordination of care. Retrospective studies suggest that 10% to 20% of OACD prescriptions are never received by the patients, but the reasons behind this are poorly understood. Objectives: To estimate the rate of failure to receive OACD prescriptions among patients with cancer and to examine the underlying reasons for this failure. Design, Setting, and Participants: A prospective cohort study was conducted among patients with cancer who were prescribed a new OACD from January 1, 2018, to December 31, 2019, at an urban academic medical center. Data analysis was conducted between 2021 and 2022. Main Outcomes and Measures: Patient demographic, clinical, and insurance data and OACD delivery dates were collected. The reasons for a failure to receive a prescribed OACD within 3 months were confirmed by manual review of medical records and were classified into 7 categories: clinical deterioration, financial access, clinician-directed change in decision-making, patient-directed change in decision-making, transfer of care, loss to follow-up, and unknown or other. A multivariable random-effects model was developed to identify factors associated with failure to receive a prescribed OACD. Results: The cohort included 1024 patients (538 men [53%]; mean [SD] age, 66.2 [13.9] years; 463 non-Hispanic White patients [45%], 140 non-Hispanic Black patients [14%], and 300 Hispanic patients [29%]), representing 1197 new OACD prescriptions. Of the 1197 prescriptions, 158 (13%) were categorized as having not been received by the patient. The most common reason for the failure to receive a prescribed OACD was due to patient and clinician decision-making (73 of 158 [46%]), and 20 cases (13%) in which prescriptions were not received were associated with financial access issues. In multivariable analysis, patients with a nonmetastatic solid malignant neoplasm were significantly less likely to not receive their OACDs than those with a hematologic malignant neoplasm (odds ratio, 0.57 [95% CI, 0.33-1.00]; P = .048). Conclusions and Relevance: This cohort study of patients prescribed a new OACD found that 13% of prescriptions were not received. The failure to receive a prescribed OACD was most frequently due to a change in clinical decision-making or patient choice. Ultimately, the reasons for the failure to receive a prescribed OACD were multifactorial and may have been appropriate in some cases.

New and Persistent Sedative-Hypnotic Use After Adjuvant Chemotherapy for Breast Cancer.

BACKGROUND: Sedative-hypnotic medications are used to treat chemotherapy-related nausea, anxiety, and insomnia. However, prolonged sedative-hypnotic use can lead to dependence, misuse, and increased health-care use. We aimed to estimate the rates at which patients who receive adjuvant chemotherapy for breast cancer become new persistent users of sedative-hypnotic medications, specifically benzodiazepines and nonbenzodiazepine sedative-hypnotics (Z-drugs). METHODS: Using the MarketScan health-care claims database, we identified sedative-hypnotic-naïve patients who received adjuvant chemotherapy for breast cancer. Patients who filled 1 and more prescriptions during chemotherapy and 2 and more prescriptions up to 1 year after chemotherapy were classified as new persistent users. Univariate and multivariable logistic regression analyses were used to estimate odds of new persistent use and associated characteristics. RESULTS: We identified 22 039 benzodiazepine-naïve patients and 23 816 Z-drug-naïve patients who received adjuvant chemotherapy from 2008 to 2017. Among benzodiazepine-naïve patients, 6159 (27.9%) filled 1 and more benzodiazepine prescriptions during chemotherapy, and 963 of those (15.6%) went on to become new persistent users. Among Z-drug-naïve patients, 1769 (7.4%) filled 1 and more prescriptions during chemotherapy, and 483 (27.3%) became new persistent users. In both groups, shorter durations of chemotherapy and receipt of opioid prescriptions were associated with new persistent use. Medicaid insurance was associated with new persistent benzodiazepine use (odds ratio = 1.88, 95% confidence interval = 1.43 to 2.47) compared with commercial or Medicare insurance. CONCLUSIONS: Patients who receive sedative-hypnotic medications during adjuvant chemotherapy for breast cancer are at risk of becoming new persistent users of these medications after chemotherapy. Providers should ensure appropriate sedative-hypnotic use through tapering dosages and encouraging nonpharmacologic strategies when appropriate.

New persistent opioid use among adolescents and young adults with sarcoma.

BACKGROUND: Adolescents and young adults (AYA) with sarcoma experience both acute and chronic pain related to their disease and treatment. Studies in older adults have reported a high risk of persistent opioid use after cancer therapy among previously opioid-naive patients; however, few studies have evaluated posttreatment opioid use among AYAs. This article describes patterns of new persistent opioid use among AYAs in the year after treatment for sarcoma. METHODS: Opioid-naive patients who were 10 to 26 years old and diagnosed with sarcoma (2008-2016) were identified with the IBM Marketscan Database. Included subjects had an International Classification of Diseases code for sarcoma (ninth or tenth revision), received anticancer therapy (chemotherapy, surgery, and/or radiation) within 30 days of the first diagnosis code, and had continuous insurance coverage (commercial or Medicaid) for more than 12 months both before the diagnosis and after the last therapy. The primary outcome was new persistent opioid use, which was defined as at least 2 opioid prescriptions in the 12 months following treatment completion. Covariates included age, sex, insurance, tumor type, surgical procedure, mental health (MH) or substance use diagnoses before or during therapy, and concomitant lorazepam use. RESULTS: In total, 938 patients met the inclusion criteria; 521 (56%) were male, and 578 (62%) were younger than 18 years. In total, 727 (78%) had commercial insurance, and 273 (29%) had an MH diagnosis either before or during the treatment period. Of the total group, 464 (49%) used opioids during treatment only. Of those who used opioids during treatment, 135 (23%) received at least 2 prescriptions in the year after therapy. In a multivariable analysis, Medicaid versus commercial insurance (odds ratio [OR], 1.74; 95% confidence interval [CI], 1.15-2.64) and non-soft tissue sarcoma (OR for Ewing sarcoma, 3.23; 95% CI, 1.81-5.78; OR for osteosarcoma, 2.05; 95% CI, 1.36-3.09) conferred a higher likelihood of new persistent use. CONCLUSIONS: In this cohort of AYAs treated for sarcoma, 64% of the patients received opioid prescriptions during treatment, and 23% of these patients became new persistent users. Because of the risks associated with persistent opioid use, studies of novel pain management strategies along with age-appropriate education and anticipatory guidance are urgently needed. LAY SUMMARY: Using an insurance claims database, we conducted a study to determine the rate of new persistent opioid use among adolescents and young adults treated for sarcoma. We found that 64% of adolescents and young adults treated for sarcoma received opioid prescriptions during treatment, and 23% of these patients met the criteria for new persistent opioid use. These findings support the need for age-appropriate education and novel pain management strategies in this vulnerable population.

New and persistent controlled substance use among patients undergoing mastectomy and reconstructive surgery.

PURPOSE: Prolonged use of controlled substances can place patients at increased risk of dependence and complications. Women who have mastectomy and reconstructive surgery (M + R) may be vulnerable to becoming new persistent users (NPUs) of opioid and sedative-hypnotic medications. METHODS: Using the MarketScan health-care claims database, we identified opioid- and sedative-hypnotic-naïve women who had M + R from 2008 to 2017. Women who filled ≥ 1 peri-operative prescription and ≥ 2 post-operative prescriptions within one year after surgery were classified as NPUs. Univariate and multivariable logistic regression analyses were used to estimate rates of new persistent use and predictive factors. Risk summary scores were created based on the sum of associated factors. RESULTS: We evaluated 23,025 opioid-naïve women and 25,046 sedative-hypnotic-naïve women. We found that 17,174 opioid-naïve women filled a peri-operative opioid prescription, and of those, 2962 (17.2%) became opioid NPUs post-operatively. Additionally, 9426 sedative-hypnotic-naïve women filled a peri-operative sedative-hypnotic prescription, and of those, 1612 (17.1%) became sedative-hypnotic NPUs. Development of new persistent sedative-hypnotic use was associated with age ≤ 49 [OR 1.77 (95% CI 1.40-2.24)] and age 50-64 [1.60 (1.27-2.03)] compared to age ≥ 65; Medicaid insurance [2.34 (1.40-3.90)]; southern residence [1.42 (1.22-1.64)]; breast cancer diagnosis [2.24 (1.28-3.91)]; and chemotherapy [2.17 (1.94-2.42)]. Risk of NPU increased with higher risk score. Women with ≥ 3 of these risk factors were three times more likely to become sedative-hypnotic NPUs than patients with 0 or 1 factors [2.94 (2.51-3.43)]. Comparable findings were seen regarding new persistent opioid use. CONCLUSION: Women who have M + R are at risk of developing both new persistent opioid and new persistent sedative-hypnotic use. A patient's risk of becoming an NPU increases as their number of risk factors increases. Non-pharmacologic strategies are needed to manage pain and anxiety following cancer-related surgery.

Care Delivery Impact of the COVID-19 Pandemic on Breast Cancer Care.

PURPOSE: COVID-19 has altered healthcare delivery. Previous work has focused on patients with cancer and COVID-19, but little has been reported on healthcare system changes among patients without COVID-19. METHODS: We performed a retrospective study of patients with breast cancer (BC) in New York City between February 1, 2020, and April 30, 2020. New patients were included as were patients scheduled to receive intravenous or injectable therapy. Patients with COVID-19 were excluded. Demographic and treatment information were obtained by chart review. Delays and/or changes in systemic therapy, surgery, radiation, and radiology related to the pandemic were tracked, along with the reasons for delay and/or change. Univariate and multivariable analysis were used to identify factors associated with delay and/or change. RESULTS: We identified 350 eligible patients, of whom 149 (42.6%) experienced a delay and/or change, and practice reduction (51.0%) was the most common reason. The patients who identified as Black or African American, Asian, or Other races were more likely to experience a delay and/or change compared with White patients (Black, 44.4%; Asian, 47.1%; Other, 55.6%; White, 31.4%; P = .001). In multivariable analysis, Medicaid compared with commercial insurance (odds ratio [OR], 3.04; 95% CI, 1.32 to 7.27) was associated with increased odds of a delay and/or change, whereas stage II or III BC compared with stage I (OR, 0.38; 95% CI, 0.15 to 0.95; and OR, 0.28; 95% CI, 0.08 to 0.092, respectively) was associated with decreased odds of a delay and/or change. CONCLUSION: Almost half of the patients with BC without COVID-19 had a delay and/or change. We found racial and socioeconomic disparities in the likelihood of a delay and/or change. Further studies are needed to determine the impact these care alterations have on BC outcomes.

Evolution of epitope-specific IgE and IgG4 antibodies in children enrolled in the LEAP trial.

BACKGROUND: In the LEAP (Learning Early About Peanut Allergy) trial, early consumption of peanut in high-risk infants was found to decrease the rate of peanut allergy at 5 years of age. Sequential epitope-specific (ses-)IgE is a promising biomarker of clinical peanut reactivity. OBJECTIVE: We sought to compare the evolution of ses-IgE and ses-IgG4 in children who developed (or not) peanut allergy and to evaluate the immunomodulatory effects of early peanut consumption on these antibodies. METHODS: Sera from 341 children (LEAP cohort) were assayed at baseline, 1, 2.5, and 5 years of age, with allergy status determined by oral food challenge at 5 years. A bead-based epitope assay was used to quantitate ses-IgE and ses-IgG4 to 64 sequential epitopes from Ara h 1 to Ara h 3 and was analyzed using linear mixed-effect models. RESULTS: In children avoiding peanut who became peanut allergic, the bulk of peanut ses-IgE did not develop until after 2.5 years. Minimal increases of ses-IgE occurred after 1 year in consumers, but not to the same epitopes as those in children developing peanut allergy. No major changes in ses-IgE were seen in nonallergic or sensitized children. IgE in sensitized consumers was detected against peanut proteins. ses-IgG4 increased over time in most children regardless of consumption or allergy status. CONCLUSIONS: Early peanut consumption in infants at high risk of developing peanut allergy appears to divert the immunologic response to a presumably "protective" effect. In general, consumers tend to generate ses-IgG4 earlier and in greater quantities than nonconsumers do, whereas only avoiders tend to generate significant quantities of ses-IgE.

Comprehensive Immunoprofiling of Pediatric Zika Reveals Key Role for Monocytes in the Acute Phase and No Effect of Prior Dengue Virus Infection.

Zika virus (ZIKV) is an emerging, mosquito-borne flavivirus responsible for recent epidemics across the Americas, and it is closely related to dengue virus (DENV). Here, we study samples from 46 DENV-naive and 43 DENV-immune patients with RT-PCR-confirmed ZIKV infection at early-acute, late-acute, and convalescent time points from our pediatric cohort study in Nicaragua. We analyze the samples via RNA sequencing (RNA-seq), CyTOF, and multiplex cytokine/chemokine Luminex to generate a comprehensive, innate immune profile during ZIKV infection. Immunophenotyping and analysis of cytokines/chemokines reveal that CD14+ monocytes play a key role during ZIKV infection. Further, we identify CD169 (Siglec-1) on CD14+ monocytes as a potential biomarker of acute ZIKV infection. Strikingly distinct transcriptomic and immunophenotypic signatures are observed at all three time points. Interestingly, pre-existing dengue immunity has minimal impact on the innate immune response to Zika. Finally, this comprehensive immune profiling and network analysis of ZIKV infection in children serves as a valuable resource.

Author Correction: Novel Bead-Based Epitope Assay is a sensitive and reliable tool for profiling epitope-specific antibody repertoire in food allergy.

An amendment to this paper has been published and can be accessed via a link at the top of the paper.

Novel Bead-Based Epitope Assay is a sensitive and reliable tool for profiling epitope-specific antibody repertoire in food allergy.

Identification of allergenic IgE epitopes is instrumental for the development of novel diagnostic and prognostic methods in food allergy. In this work, we present the quantification and validation of a Bead-Based Epitope Assay (BBEA) that through multiplexing of epitopes and multiple sample processing enables completion of large experiments in a short period of time, using minimal quantities of patients' blood. Peptides that are uniquely coupled to beads are incubated with serum or plasma samples, and after a secondary fluorophore-labeled antibody is added, the level of fluorescence is quantified with a Luminex reader. The signal is then normalized and converted to epitope-specific antibody binding values. We show that the effect of technical artifacts, i.e. well position or reading order, is minimal; and batch effects - different individual microplate runs - can be easily estimated and eliminated from the data. Epitope-specific antibody binding quantified with BBEA is highly reliable, reproducible and has greater sensitivity of epitope detection compared to peptide microarrays. IgE directed at allergenic epitopes is a sensitive biomarker of food allergy and can be used to predict allergy severity and phenotypes; and quantification of the relationship between epitope-specific IgE and IgG4 can further improve our understanding of the immune mechanisms behind allergic sensitization.

Longitudinal Tracking of Sound Exposure and Hearing Aid Usage through Objective Data Logs.

Objective To use data-logging technology to objectively track and identify predictors of hearing aid (HA) usage and aided sound exposure. Study Design Case series with planned data collection. Setting Tertiary academic medical center. Subjects and Methods Individuals with HAs between 2007 and 2016 were included (N = 431; mean, 74.6 years; 95% CI, 73.1-76.0). Data-logging technology intrinsic to new-generation HAs was enabled to track usage and sound exposure. With multivariable linear regression, age, sex, number of audiology visits, duration of audiologic follow-up, pure tone average, and HA side were assessed as predictors of usage (hours/day) and aided sound exposure (dB-hours/day; ie, "dose" of sound per day). Results Mean follow-up was 319 days (95% CI, 277-360). Mean HA usage was 8.4 hours/day (95% CI, 8.0-8.8; N = 431). Mean aided sound exposure was 440 dB-hours/day (95% CI, 385-493; n = 110). HA use (ß < 0.001, P = .45) and aided sound exposure (ß = -0.006, P = .87) were both stable over time. HA usage was associated only with hearing loss level (pure tone average; ß = 0.030, P = .04). Aided sound exposure was associated only with duration of audiologic follow-up (ß = 0.100, P = .02). Conclusion While measurement of HA use has traditionally relied on subjective reporting, data logging offers an objective tool to longitudinally track HA use and sound exposure. We demonstrate the feasibility of using this potentially powerful research tool. Usage and sound exposure were stable among patients throughout the study period. Use was greater among subjects with greater hearing loss. Maximizing aided sound exposure might be possible through continued audiology follow-up visits.