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Food and Drug Administration's Center for Drug Evaluation and Research defines patient-reported outcomes as "any report of the status of a patient's health condition, health behavior, or experience with healthcare that comes directly form the patient, without interpretation of the patient's response by a clinician or anyone else." Validated patient-reported outcome measures are used extensively in pediatric and adult asthma across clinical and research settings to assess the impact of treatments on patient outcomes over time. This work aims to review some of the most commonly used asthma patient-reported outcomes across the following criteria: validity, reliability, responsiveness, time to complete, ease of administration, target population, recall period, scoring method, availability in different languages, use in clinical practice or research settings, licensing requirements, and cost of use., (Copyright © 2024 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)

Purpose of Review: Although digital inhaler systems for asthma management have been commercially available for over a decade, their current use in clinical practice is limited. This review outlines barriers and offers potential solutions to their implementation., Recent Findings: Digital inhaler systems demonstrate increased controller medication adherence, decreased quick-relief medication use, and improved asthma control., Summary: Use of digital inhaler systems is supported by data from large clinical trials demonstrating improved asthma outcomes. Navigating telemedicine during the coronavirus disease 2019 pandemic has led to advances clearing the path for increased adoption of digital inhaler systems. Progress in areas including patient education and onboarding, clinical management, coding and billing, privacy and security have facilitated implementation in clinical practice., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

The coronavirus disease 2019 (COVID-19) pandemic has disproportionately affected disadvantaged populations. Many of the factors related to the disproportionate impact on underserved communities are related to social determinants of health, defined by the World Health Organization as the nonmedical factors that influence health outcomes. They include the wider set of forces and systems shaping the conditions of daily life. This work explores the interrelationships between social determinants of health and access to care, health care professional and supply shortages, social and environmental factors, health behaviors, vaccine uptake, and treatment options on COVID-19 health outcomes. Increased awareness of inequities, learning from failures, and leveraging new opportunities to partner with key stakeholders in underserved communities create empowerment and preparedness to face new challenges., (Copyright © 2023 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)

Food allergy is a global health problem affecting up to 10% of the world population. Accurate diagnosis of food allergies, however, is still a major challenge in medical offices and for patients seeking alternative avenues of diagnosis. A flawless test to confirm or rule out a food allergy does not exist. The lack of optimum testing methods to establish precise clinical correlations remains a major obstacle to effective treatment. Certain IgE measurement methods, including component testing, have received FDA clearance, but they have been used primarily as an analytical tool and not to establish clinical correlations. Most allergy tests are still carried out within the laboratory, and skin tests outside a laboratory setting that are used for food allergy diagnosis rely on non-standardized allergens, according to the FDA definition. Epitope mapping and basophil activation test (BAT) have recently been proposed as a means of establishing better clinical correlations. Yet neither have received FDA clearance for widespread distribution. Of the two methods, the BAT has the advantage of being a functional assay. Over the past few years, several large private practice groups in the United States, have developed BAT as a clinical assay and have started using it in patient care. Given this clinical experience, the vast number of papers published on BAT (more than 1,400 as of 2022) and the trend toward increasing FDA regulation, it is essential to understand the roadmap for regulatory clearance of this assay., Competing Interests: SO’R was employed by New Columbia Capital, LLC. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2023 Alpan, Wasserman, Kim, Darter, Shah, Jones, McNeil, Li, Ispas, Rathkoph, Perez, Siri, O'Connor, Plassmeyer, Romito, Pettibone, O'Reilly, Sønder and Marti.)

Background: The short stability window of several hours from blood collection to measuring basophil activation has limited the use of flow cytometry-based basophil activation assays in clinical settings. We examine if it is possible to extend this window to 1 day allowing for shipment of samples between laboratories. Several options exist for reporting the results including reporting all the measured values directly, calculating ratios and reporting a single value covering all measured results. Each of these options have different stability and value to the physician., Methods: Whole blood samples from peanut allergic patients were stimulated with four different peanut concentrations at Day 0, Day 1, and Day 2. Samples were stored under temperature-controlled conditions. Flow cytometry was used to analyze the samples. The basophil activation and degranulation were measured as percentage of positive CD63 basophils and CD203c MFI fold change. Shipped samples were transported under ambient conditions., Results: The results show that CD63 is a stable marker at Day 1. The CD203c ratio decreases significantly at Day 1. Calculating the CD63/IgE ratio proves to be more stable than CD63 alone. The most stable readouts are the semi-quantitative results and the trajectory of the dose response curve. Finally, we confirmed that the stability can be extended to samples shipped overnight to the laboratory., Conclusions: It is possible to extend the stability of the basophil activation assay to 1 day for samples stored at 18-25°C as well as samples shipped under ambient conditions as long as the temperature is within the 2-37°C range., (© 2021 The Authors. Cytometry Part B: Clinical Cytometry published by Wiley Periodicals LLC on behalf of International Clinical Cytometry Society.)

Immunization with BioThrax(®) (Anthrax Vaccine Adsorbed) is a safe and effective means of preventing anthrax. Animal studies have demonstrated that the addition of CpG DNA adjuvants to BioThrax can markedly increase the immunogenicity of the vaccine, increasing both serum anti-protective antigen (PA) antibody and anthrax toxin-neutralizing antibody (TNA) concentrations. The immune response to CpG-adjuvanted BioThrax in animals was not only stronger, but was also more rapid and led to higher levels of protection in spore challenge models. The B-class CpG DNA adjuvant CPG 7909, a 24-base synthetic, single-strand oligodeoxynucleotide, was evaluated for its safety profile and adjuvant properties in a Phase 1 clinical trial. A double-blind study was performed in which 69 healthy subjects, age 18-45 years, were randomized to receive three doses of either: (1) BioThrax alone, (2) 1 mg of CPG 7909 alone or (3) BioThrax plus 1 mg of CPG 7909, all given intramuscularly on study days 0, 14 and 28. Subjects were monitored for IgG to PA by ELISA and for TNA titers through study day 56 and for safety through month 6. CPG 7909 increased the antibody response by 6-8-fold at peak, and accelerated the response by 3 weeks compared to the response seen in subjects vaccinated with BioThrax alone. No serious adverse events related to study agents were reported, and the combination was considered to be reasonably well tolerated. The marked acceleration and enhancement of the immune response seen by combining BioThrax and CPG 7909 offers the potential to shorten the course of immunization and reduce the time to protection, and may be particularly useful in the setting of post-exposure prophylaxis., (Copyright © 2011 Elsevier Ltd. All rights reserved.)