Comparison of Systemic Exposure Between Epinephrine Delivered via Metered-Dose Inhalation and Intramuscular Injection.

Background: Primatene® MIST, an epinephrine metered-dose inhaler (MDI), has long been questioned by some medical professionals for asthma treatment despite having been approved by the Food and Drug Administration. One of the primary reasons for their concerns stemmed from potential cardiovascular complications following epinephrine administration. However, the majority of documented cardiovascular complications seemed to occur following the injection route of the epinephrine. The aim of this study was to evaluate the systemic exposure of epinephrine delivered through different administration routes and to understand its relationship with cardiovascular effects. Since albuterol inhalers are commonly recommended for asthma, albuterol was also studied as a comparator drug. Method: A randomized, evaluator-blinded, three-arm crossover study was conducted in 28 healthy adult subjects to compare the profiles of systemic exposure for epinephrine delivered by MDI versus epinephrine intramuscular (IM) injection and albuterol MDI. Serially sampled plasma epinephrine and albuterol levels were measured and compared between treatment groups. Safety was assessed by adverse events, serial vital signs, electrocardiograms (ECGs), and clinical laboratory tests obtained at each crossover dosing visit. Results: Systemic exogenous drug exposure for inhaled epinephrine MDI (39 pg/mL × hour) was ∼9 times lower than that of epinephrine IM (435 pg/mL × hour) and 122 times lower than that of albuterol MDI (3453 pg/mL × hour) after dose normalization. The Cmax in epinephrine MDI (345 pg/mL) was approximately half of that of epinephrine IM (816 pg/mL) and that of albuterol MDI (681 pg/mL). Plasma drug concentrations for epinephrine MDI dropped rapidly to baseline (∼0.6 hour), while epinephrine IM took ∼8 hours, and albuterol MDI required more than 24 hours. Epinephrine MDI and albuterol MDI resulted in minimal, clinically insignificant changes in vital signs and ECGs, whereas epinephrine IM led to mild transient increases in systolic blood pressure, heart rate, and corrected QT interval. Conclusion: Epinephrine MDI (Primatene MIST) had ∼9 times lower systemic drug exposure (SDE) than that of epinephrine IM and ∼122 times lower than that of albuterol MDI. The lower SDE of inhaled epinephrine also correlated with reassuring safety findings, with no significant cardiovascular adverse effects found, compared with transient effects seen after IM epinephrine. Clinical trial registration number: NCT04207840.

Decisions With Patients, Not for Patients: Shared Decision-Making in Allergy and Immunology.

Shared decision-making (SDM) is an increasingly implemented patient-centered approach to navigating patient preferences regarding diagnostic and treatment options and supported decision-making. This therapeutic approach prioritizes the patient's perspectives, considering current medical evidence to provide a balanced approach to clinical scenarios. In light of numerous recent guideline recommendations that are conditional in nature and are clinical scenarios defined by preference-sensitive care options, there is a tremendous opportunity for SDM and validated decision aids. Despite the expansion of the literature on SDM, formal acceptance among clinicians remains inconsistent. Surprisingly, a significant disparity exists between clinicians' self-reported adherence to SDM principles and patients' perceptions of its implementation during clinical encounters. This discrepancy underscores a fundamental issue in the delivery of health care, where clinicians may overestimate their integration of SDM, while patients' experiences suggest otherwise. This review critically examines the factors contributing to this inconsistency, including barriers within the health care system, clinician attitudes and behaviors, and patient expectations and preferences. By elucidating these factors in the fields of food allergy, asthma, eosinophilic esophagitis, and other allergic diseases, this review aims to provide insights into bridging the gap between clinician perception and patient experience in SDM. Addressing this discordance is crucial for advancing patient-centered care and ensuring that SDM is not merely a theoretical concept but a tangible reality in the.

Real-world use and perceptions of shared decision-making for allergy and asthma care in a US population.

Background: Shared decision-making (SDM), the process of engaging patients in their healthcare decisions, is an integral component of personalized medicine. The use of SDM in real-world allergy and asthma care in the United States (US) is unknown. Cross-sectional surveys of allergists and patients in a US population were conducted to assess the use and perceptions of SDM and SDM tools in real-world allergy and asthma care. Methods: Allergists (N = 101) who were members of the American College of Allergy Asthma & Immunology (ACAAI) and who were also Dynata (a marketing research firm) research partners or in the Allergy & Asthma Network customer database completed an online survey from February-March 2022. Adult patients (N = 110) with asthma, allergy, and/or eczema in the United States who were participants of online research panels hosted by Dynata completed on online survey from February 1-7, 2022. Results: Based on their own definition, 98% of the allergists reported familiarity with SDM, and 79% reported using it frequently. Allergists reported using SDM with an average of 44% of their patients. The most commonly used tool was the Immunotherapy SDM toolkit (40%); 43% had not used any SDM tool. Among allergists not using SDM or using it infrequently (n = 19), 42% considered it too time-consuming and 37% believed their patients have low health literacy. Of the surveyed patients, 25% reported their provider used SDM "frequently" or "occasionally" when being treated for allergies, asthma, or eczema, and 22% reported using SDM tools with their provider at some point. The most commonly used tool was the Asthma and Allergy Symptom Test (60%). Among patients whose allergists used SDM infrequently or never (n = 56), 70% reported they would be likely to ask their allergist to use SDM more often. Conclusion: Survey responses revealed a disconnect between allergists and patients regarding SDM use. Barriers to SDM are consistent with those across the healthcare industry. Patients clearly expressed their desire for SDM.

Allergen immunotherapy and shared decision-making.

Clinical decision-making in allergic rhinoconjunctivitis management involves a significant degree of complexity given the number of pharmaceutical agents; the option for allergen immunotherapy (AIT); and the risk for disease advancement, including the development of asthma as well as new environmental allergic sensitivities. Given the complex array of treatment options that are currently available, there is an opportunity to use a shared decision-making (SDM) approach with associated aids and tools that facilitate the interactive participation of practitioners and patients in the SDM process. This article reviews the general constructs of SDM, the unmet need for SDM aids, the collection of patient preference data for allergic rhinoconjunctivitis, the utility of SDM aids which have been specifically created for AIT, and outlines actionable steps to implement AIT SDM in clinical practice.

COVID-19 pandemic impact on telehealth use and perceptions for atopic and respiratory disease: Survey results.

Background: Telehealth use increased during the coronavirus disease 2019 (COVID-19) pandemic to provide patient care while deferring to social distancing recommendations. Objective: Health-care provider and patient surveys were conducted to assess the impact of COVID-19 on the use and perception of telehealth visits for atopic and respiratory diseases. Methods: Health-care provider (N = 200) and patient (N = 200) surveys were conducted in the United States between September and October, 2020, and January, 2021. The participants were required to have used telehealth before or after March 1, 2020, the cutoff date selected to represent the start of the COVID-19 pandemic. Results: Before the pandemic, 40% of the health-care provider participants were conducting telehealth visits, which increased to 100% after the pandemic started. The average time spent per telehealth visit with patients increased from 13 to 16 minutes. A higher percentage of family medicine physicians/pediatricians had access to most monitoring tools than allergy/dermatology specialists both before the pandemic and after the pandemic started. Practice expenses reportedly increased after the pandemic started for 42% of participants. Before the pandemic, 27% of the patient participants used telehealth, which increased to 94% after the pandemic started. Ratings of "good" or "excellent" for the overall telehealth experience by the health-care provider participants improved from 44% before to 60% after the pandemic started, and by the patient participants improved from 77% to 88%. The willingness by the health-care provider participants to recommend telehealth to colleagues improved from 73% before to 83% after the pandemic started. The willingness by the patient participants to use telehealth again dropped slightly, from 94% to 89%. Conclusion: Telehealth visits for atopic and respiratory diseases increased during the COVID-19 pandemic. Telehealth experiences were overall positive, particularly for the patients.

Impact of Social Determinants on the Burden of Asthma and Eczema: Results from a US Patient Survey.

INTRODUCTION: Little is known about how patients with asthma and eczema perceive their medical care and burden of disease. A survey was conducted to evaluate the perceptions among the general patient population with asthma and/or eczema regarding disease and treatment burden and barriers to adequate care. METHODS: An online survey was completed by market research panelists in the USA between March 24, 2020 and April 6, 2020. Eligible participants were at least 18 years of age and endorsed a diagnosis of asthma and/or eczema. Survey responses are described for all participants, by designated racial/ethnic groups, and by income level. RESULTS: In all, 841 participants completed the survey (asthma, n = 554; eczema, n = 398; both, n = 111; White, n = 421; Black, n = 252; Hispanic, n = 95; low income [less than $15,000/year], n = 99; higher income [at least $15,000/year], n = 713). More Black and Hispanic participants than White participants, and more participants with low income than higher income, endorsed health literacy as a barrier (e.g., filling out official documents, understanding written materials). Participants with low income were less likely than participants with higher income to have an asthma action plan (42% vs 53%, respectively) and to discuss asthma control with their healthcare provider (54% vs 69%). Black and Hispanic participants were more likely than White participants to have an emergency department visit (52% and 49% vs 31%, respectively) or hospitalization (31% and 39% vs 16%) for asthma within the last 12 months. Participants reporting low income indicated that they experienced eczema symptoms more frequently than participants with higher income; 35% of low-income participants vs 15% of higher-income participants reported that they had not tried any eczema treatments. Participants in all racial/ethnic and income-level groups reported that their asthma or eczema impacted their lifestyle and daily activities. CONCLUSION: More effective and culturally informed communication and education strategies to improve health information uptake and shared decision-making are needed to reduce the burdens of disease and treatment in highly impacted populations.

Disparities in asthma and eczema outcomes have been described in various populations. However, little is known about how these patient populations perceive their disease management or disease burden. A survey of 841 adults across diverse demographic groups in the USA with asthma and/or eczema was conducted to evaluate overall perceived disease burden and to specifically understand burden experiences by marginalized populations. In general, all participants indicated that asthma and eczema have a negative physical, emotional, and social impact on their lives. Some participants who identified as Black or Hispanic, and those with low income (less than $15,000/year), indicated greater difficulties in filling out paperwork or understanding written materials related to their condition than White participants or those with higher incomes. Black and Hispanic participants tended to receive asthma care in the emergency department or urgent care more than White participants and had more emergency department visits and hospitalizations than White Participants. Participants with low income were less likely to discuss their asthma management with their doctor than those with higher incomes and also indicated potential undertreatment of eczema. These results indicate that Black, Hispanic, or low-income patients may experience barriers to health equity. These barriers include lack of effective communication methods and materials to meet the needs of all patients, as well as the overall lack of quality healthcare access. These challenges must be addressed to overcome social disparities in health.

Shifts in allergy practice in a COVID-19 world: Implications of pre-COVID-19 national health care provider and patient surveys of treatments for nasal allergies.

Background: Most U.S. patient and health care provider surveys with regard to nasal allergy treatments were conducted before sublingual immunotherapy (SLIT)-tablets and allergy immunotherapy (AIT) shared decision-making tools were available. Objective: Patient and health care provider surveys with regard to current perceptions of nasal allergy burden, symptoms, and treatments were conducted to compare with previous surveys and provide insight into the use of SLIT-tablets and AIT shared decision-making tools. Methods: From November-December 2019, adults (N = 510) diagnosed with nasal allergies and health care providers (N = 304) who treated nasal allergies in the United States completed surveys with regard to nasal allergy management. Results: Of the patient respondents, 42% reported that their symptoms were only somewhat controlled and 48% had avoided activities because of their nasal allergies. In all, 38% were using only over-the-counter (OTC) medications for treatment, and 42%, 7%, and 8% had ever received subcutaneous immunotherapy (SCIT), sublingual allergy drops, or SLIT-tablets, respectively; 56% and 85% reported that they had never discussed SCIT or SLIT, respectively, with their health care provider. Of the health care provider respondents, 45%, 58%, and 20% were very likely to discuss OTC medications, SCIT, or SLIT, respectively. Allergists were more inclined to discuss SCIT with their patients than other health care providers (82% versus 33%, respectively). Most allergists (67%) and other health care providers (62%) reported that they did not use an AIT shared decision-making tool, primarily because of unawareness. Conclusion: The patients with nasal allergies continued to report inadequate symptom control and activity impairment. SLIT-tablets and AIT shared decision-making tools were underused. In the coronavirus disease 2019 era, social distancing may limit office visits, which impacts SCIT administration and prompts increased use of telemedicine and a possible advantage for at-home-administered SLIT-tablets over SCIT.

Digital Health Technology in Asthma: A Comprehensive Scoping Review.

BACKGROUND: A variety of digital intervention approaches have been investigated for asthma therapy during the past decade, with different levels of interactivity and personalization and a range of impacts on different outcome measurements. OBJECTIVE: To assess the effectiveness of digital interventions in asthma with regard to acceptability and outcomes and evaluate the potential of digital initiatives for monitoring or treating patients with asthma. METHODS: We evaluated digital interventions using a scoping review methodology through a literature search and review. Of 871 articles identified, 121 were evaluated to explore intervention characteristics, the perception and acceptability of digital interventions to patients and physicians, and effects on asthma outcomes. Interventions were categorized by their level of interactivity with the patient. RESULTS: Interventions featuring non-individualized content sent to patients appeared capable of promoting improved adherence to inhaled corticosteroids, but with no identified improvement in asthma burden; and data-gathering interventions appeared to have little effect on adherence or asthma burden. Evidence of improvement in both adherence and patients' impairment due to asthma were seen only with interactive interventions involving two-way responsive patient communication. Digital interventions were generally positively perceived by patients and physicians. Implementation was considered feasible, with certain preferences for design and features important to drive use. CONCLUSIONS: Digital health interventions show substantial promise for asthma disease monitoring and personalization of treatment. To be successful, future interventions will need to include both inhaler device and software elements, combining accurate measurement of clinical parameters with careful consideration of ease of use, personalization, and patient engagement aspects.

Hereditary angioedema and shared decision making.

Clinical decision-making in hereditary angioedema (HAE) management involves a high degree of complexity given the number of therapeutic agents that are available and the risk for significant morbidity and potential mortality attributable to the disease. Given this complexity, there is an opportunity to develop shared decision-making (SDM) aids and/or tools that would facilitate the interactive participation of practitioners and patients in the SDM process. This article reviews the general constructs of SDM, the unmet need for SDM in HAE, and the steps necessary to create a SDM tool specific for HAE, and outlines the challenges that must be navigated to guide the establishment and widespread implementation of SDM in the management of HAE.

A review of shared decision-making: A call to arms for health care professionals.

OBJECTIVE: To illustrate the use of shared decision-making (SDM) and SDM tools and aids as the essential components in the care of asthma. DATA SOURCES: We reviewed individual randomized controlled studies conducted between 1998 and 2020 to compare SDM interventions and the use of SDM tools and aids for the care of asthma. All studies were published or translated in English. STUDY SELECTIONS: We excluded studies of interventions that involved multiple components other than the SDM intervention unless the control group also received these interventions. We evaluated the existing literature on both SDM tools and aids and the process of SDM to summarize in this review. RESULTS: Shared decision-making tools and aids most commonly clarify the diagnostics and options for a treatment. The 6 elements of SDM were clearly supported. We found no considerable association between the presence of these elements of SDM and asthma outcomes. CONCLUSION: We found that SDM for asthma and SDM tools and aids were often made to transfer information about asthma treatment options and their harms and benefits. The correlation between their support of SDM key elements and their impact on asthma outcomes is often difficult to ascertain but when present, there was positive correlation to improving risk communication, adherence, patient satisfaction, and possibly decreasing liability.

The Challenges and Opportunities for Shared Decision Making Highlighted by COVID-19.

Shared decision making (SDM) is a management paradigm that empowers patients as partners in their own care in a bidirectional exchange of information and values, and optimize the decision-making process. During the current coronavirus disease 2019 pandemic, there is a greater need to encourage participation in the SDM process. The pandemic has created both challenges and opportunities for delivering care, as system adaptations influence the physician-patient relationship. Although social distancing and health service reallocation can interfere with preference for an in-person visit, these measures also provide an avenue to study and implement virtual SDM processes. Communicating risk at a time of heightened uncertainty may pose a barrier to SDM engagement but provides the opportunity to foster a patient-centered approach within a more personalized context. Social media influence during coronavirus disease 2019 has resulted in an "infodemic" but highlights the importance of patient engagement. The pandemic has changed how we deliver care but allows us to re-evaluate common practices and enhance effectiveness of our management strategies. Navigating the uncertainty of subsequent pandemic waves creates confusion about how to safely reinitiate clinical service. This will require ongoing SDM with our patients and among colleagues through current-and future-challenges. Coronavirus disease 2019 has created many difficulties but has forced us to reexamine how to provide more patient-centered and high-quality care.

Development and acceptability of a shared decision-making tool for commercial peanut allergy therapies.

BACKGROUND: Shared decision making (SDM) is the process through which patients and their medical provider mutually explore therapy goals, risk/benefit, and treatment options regarding medical care. Decision aids are tools that aid in the process of values clarification and help assess decisional needs and potential decisional conflicts. OBJECTIVE: To develop and assess acceptability of a decision aid for commercial peanut allergy therapies. METHODS: The creation of this decision aid occurred in 3 stages, including a qualitative study to assess decisional needs, development of a draft decision aid through multiple iterations in accordance with international guidelines and decision aid experts, and assessment of decisional acceptability, decisional conflict, and decisional self-efficacy related to using the decision aid. RESULTS: The decision aid went through 9 iterations, resulting in a 4-page aid with 7 parts, explaining the therapies, key risks and benefits of therapy choices, relative importance of key attributes of the therapies, and a self-check assessment regarding informational adequacy and how to take the next steps. A total of 24 subjects assessed the decision aid, noting it had good acceptability, high decisional self-efficacy (mean score 91.9/100), and low decisional conflict (mean score 20.2/100). Respondents rated the information content as adequate and sufficient and the information regarding the therapy choices as fair and balanced without a clear bias or presenting a "best choice." CONCLUSION: We have developed this decision aid as a tool to help caregivers navigate the complexity of decision making for peanut allergy treatment options. The decision aid was noted to have good acceptability, with scores reflective of the instrument enhancing decisional self-efficacy and reducing decisional conflict.

Shared decision making for the allergist.

OBJECTIVE: Shared decision making (SDM) is becoming more commonly appreciated and used in medical practice as a way to empower patients who are facing treatment preference-sensitive conditions, such as allergic rhinitis, atopic dermatitis, food allergy, and persistent asthma. The purpose of this review is to educate the allergy health care provider about how SDM works and provide practical advice and allergist-specific SDM resources. DATA SOURCES: PubMed and online patient decision aid resources. STUDY SELECTIONS: Studies and reviews relevant to SDM and patient decision aids relevant to the allergy health care provider were selected for discussion. RESULTS: There are ethical, practical, economic, and psychological imperatives for the implementation of quality SDM, particularly for chronic diseases. Many benefits and barriers of SDM have been identified and models have been developed to encourage implementation of quality SDM. For the allergy health care provider, SDM for asthma has been shown to improve adherence, outcomes, and patient satisfaction with care. Patient decision aids are useful tools for SDM and have recently been developed for allergen immunotherapy, severe asthma, and atopic dermatitis. CONCLUSION: Effective SDM has been shown to improve adherence and lead to better outcomes. SDM should be universally implemented as a key component of patient-centered health care. Allergy health care providers should work with their patients to reach treatment decisions that align with their values and preferences.

Pharmacoeconomics of Biologic Therapy.

Novel biologic agents have allowed clinicians to achieve improved patient outcomes. Appropriate pharmacoceconomic analyses demand evaluation of all relevant costs, including the treatments, the disease and comorbidities, and costs of alternative treatments, including their short- and long-term side effects. Only with complete data can the value of therapies be correctly estimated. By assessing costs, pharmacoeconomic studies complement studies of efficacy and safety, helping to determine the relationships of treatment and outcome. This article provides a broad framework for understanding and evaluating published economic analyses and identifying the key costs and benefits caring for patients with asthma and other immune diseases.

Patient adherence and effective communication.

BACKGROUND: Poor adherence to inhaled corticosteroid medication is a critical problem for asthma because it contributes to morbidity and mortality through poor asthma control, frequent asthma exacerbations, acute care visits, and oral corticosteroid use. OBJECTIVE: To discuss evidence-based, time-efficient strategies that can be adopted by most practitioners to try to increase patient adherence. METHODS: Asthma management guidelines and other key publications are used to enhance discussion. RESULTS: Establishing patient-centered, collaborative care that permits effective patient-practitioner communication can improve adherence, thus leading to improved asthma outcomes. One critical strategy is shared decision making, in which the patient and the practitioner share relevant information, discuss risks vs benefits of various treatment options, express treatment preferences, deliberate the options, and agree on treatment. Asthma self-management education, which emphasizes self-efficacy, is also essential. The education necessary to provide those skills depends in part on consideration of the patient's health literacy. Practitioners also have at their disposal a variety of tips and techniques to improve communication and gather information not only at the patient-practitioner level but also at the practitioner-practitioner level, such as within a group practice or within a health care system. CONCLUSION: To improve patient adherence, clinicians need to consider a variety of factors and implement strategies that directly target underlying issues. Strategies may include customizing and simplifying learning and intervention regimens, identifying barriers to adherence and addressing them, ensuring patient support structures are in place, and improving self-efficacy and health literacy.

The economic impact of allergic rhinitis and current guidelines for treatment.

OBJECTIVE: To describe the economic burden of allergic rhinitis treatment and current guidelines for treatment. DATA SOURCES: Review articles and original research were retrieved from MEDLINE, OVID, PubMed (1950-November 2009), personal files of articles, and bibliographies of located articles that addressed the topic of interest. STUDY SELECTION: Articles were selected for their relevance to the burden of allergic rhinitis and current guidelines for treatment. Publications included reviews, treatment guidelines, and clinical studies. RESULTS: Despite the common symptoms of allergic rhinitis, its impact on patient quality of life, and the huge cost to society and individuals of treatment, including pharmacotherapy, many patients do not adhere to their medication regimens because the medications do not adequately address their symptoms or are otherwise problematic for them to use. CONCLUSIONS: The economic impact of allergic rhinitis is substantial; the total direct medical cost of allergic rhinitis is approximately $3.4 billion, with almost half of this cost attributable to prescription medications. Multiple treatment options are available, and these were reviewed to provide an update on effectiveness and adverse effects that may affect patient adherence.