41 results on '"Mosnaim GS"'
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2. Do we have evidence that pediatric written asthma action plans really work?
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Mosnaim GS
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- 2011
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3. Pharmacoequity and Biologics in the Allergy Clinic: Providing the Right Care, at the Right Time, Every Time, to Everyone.
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Conway AE, Lieberman J, Codispoti CD, Mahdavinia M, Anagnostou A, Hsu Blatman KS, Lang DM, Oppenheimer J, Mosnaim GS, Bukstein D, and Shaker M
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- Humans, Hypersensitivity drug therapy, Health Services Accessibility, Biological Products therapeutic use
- Abstract
Pharmacoequity refers to equity in access to pharmacotherapy for all patients and is an especially large barrier to biologic agents in patients with allergic diseases. Value-based care models can prompt clinicians to address social determinants of health, promoting pharmacoequity. Pharmacoequity is influenced by numerous factors including socioeconomic status, which may be mediated through insurance status, educational attainment, and access to specialist care. In addition to lower socioeconomic status, race and ethnicity, age, locations isolated from care systems, and off-label indications for biologic agents all constitute barriers to pharmacoequity. Whereas pharmaco-inequity is more apparent for expensive biologics, it also affects many other allergy treatments including epinephrine autoinjectors and SMART for asthma. Current programs aimed at alleviating cost barriers are imperfect. Patient assistance programs, manufacturer-sponsored free drug programs, and rebates often increase the complexity of care, with resultant inequity, particularly for patients with lower health literacy. Ultimately, single silver-bullet solutions are elusive. Long-term improvement instead requires a combination of research, advocacy, and creative problem-solving to design more intelligent and efficient systems that provide timely access to necessary care for every patient, every time., (Copyright © 2024 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)
- Published
- 2024
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4. Simplifying asthma management in a university setting: A perspective.
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Bracken AC, Oppenheimer JJ, Mosnaim GS, and Rank MA
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- Humans, Universities, Anti-Asthmatic Agents therapeutic use, Disease Management, Asthma drug therapy
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- 2024
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5. Outpatient COVID-19 convalescent plasma recipient antibody thresholds correlated to reduced hospitalizations within a randomized trial.
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Park HS, Yin A, Barranta C, Lee JS, Caputo CA, Sachithanandham J, Li M, Yoon S, Sitaras I, Jedlicka A, Eby Y, Ram M, Fernandez RE, Baker OR, Shenoy AG, Mosnaim GS, Fukuta Y, Patel B, Heath SL, Levine AC, Meisenberg BR, Spivak ES, Anjan S, Huaman MA, Blair JE, Currier JS, Paxton JH, Gerber JM, Petrini JR, Broderick PB, Rausch W, Cordisco ME, Hammel J, Greenblatt B, Cluzet VC, Cruser D, Oei K, Abinante M, Hammitt LL, Sutcliffe CG, Forthal DN, Zand MS, Cachay ER, Raval JS, Kassaye SG, Marshall CE, Yarava A, Lane K, McBee NA, Gawad AL, Karlen N, Singh A, Ford DE, Jabs DA, Appel LJ, Shade DM, Lau B, Ehrhardt S, Baksh SN, Shapiro JR, Ou J, Na YB, Knoll MD, Ornelas-Gatdula E, Arroyo-Curras N, Gniadek TJ, Caturegli P, Wu J, Ndahiro N, Betenbaugh MJ, Ziman A, Hanley DF, Casadevall A, Shoham S, Bloch EM, Gebo KA, Tobian AA, Laeyendecker O, Pekosz A, Klein SL, and Sullivan DJ
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- Humans, Male, Female, Middle Aged, Adult, Immunoglobulin G blood, Immunoglobulin G immunology, Antibodies, Neutralizing immunology, Antibodies, Neutralizing blood, Double-Blind Method, Aged, Blood Donors statistics & numerical data, Outpatients, COVID-19 immunology, COVID-19 therapy, COVID-19 Serotherapy, Antibodies, Viral blood, Antibodies, Viral immunology, Immunization, Passive methods, Hospitalization statistics & numerical data, SARS-CoV-2 immunology
- Abstract
BACKGROUNDCOVID-19 convalescent plasma (CCP) virus-specific antibody levels that translate into recipient posttransfusion antibody levels sufficient to prevent disease progression are not defined.METHODSThis secondary analysis correlated donor and recipient antibody levels to hospitalization risk among unvaccinated, seronegative CCP recipients within the outpatient, double-blind, randomized clinical trial that compared CCP to control plasma. The majority of COVID-19 CCP arm hospitalizations (15/17, 88%) occurred in this unvaccinated, seronegative subgroup. A functional cutoff to delineate recipient high versus low posttransfusion antibody levels was established by 2 methods: (i) analyzing virus neutralization-equivalent anti-Spike receptor-binding domain immunoglobulin G (anti-S-RBD IgG) responses in donors or (ii) receiver operating characteristic (ROC) curve analysis.RESULTSSARS-CoV-2 anti-S-RBD IgG antibody was volume diluted 21.3-fold into posttransfusion seronegative recipients from matched donor units. Virus-specific antibody delivered was approximately 1.2 mg. The high-antibody recipients transfused early (symptom onset within 5 days) had no hospitalizations. A CCP-recipient analysis for antibody thresholds correlated to reduced hospitalizations found a statistical significant association between early transfusion and high antibodies versus all other CCP recipients (or control plasma), with antibody cutoffs established by both methods-donor-based virus neutralization cutoffs in posttransfusion recipients (0/85 [0%] versus 15/276 [5.6%]; P = 0.03) or ROC-based cutoff (0/94 [0%] versus 15/267 [5.4%]; P = 0.01).CONCLUSIONIn unvaccinated, seronegative CCP recipients, early transfusion of plasma units in the upper 30% of study donors' antibody levels reduced outpatient hospitalizations. High antibody level plasma units, given early, should be reserved for therapeutic use.TRIAL REGISTRATIONClinicalTrials.gov NCT04373460.FUNDINGDepartment of Defense (W911QY2090012); Defense Health Agency; Bloomberg Philanthropies; the State of Maryland; NIH (3R01AI152078-01S1, U24TR001609-S3, 1K23HL151826NIH); the Mental Wellness Foundation; the Moriah Fund; Octapharma; the Healthnetwork Foundation; the Shear Family Foundation; the NorthShore Research Institute; and the Rice Foundation.
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- 2024
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6. Cost-effectiveness of budesonide-formoterol vs inhaled epinephrine in US adults with mild asthma.
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Ho JK, Shaker M, Greenhawt M, Sadatsafavi M, Abrams EM, Oppenheimer J, Mosnaim GS, Lee TY, and Johnson KM
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- Adult, Humans, Bronchodilator Agents therapeutic use, Budesonide therapeutic use, Cost-Benefit Analysis, Formoterol Fumarate therapeutic use, Ethanolamines therapeutic use, Epinephrine therapeutic use, Drug Combinations, Administration, Inhalation, Budesonide, Formoterol Fumarate Drug Combination therapeutic use, Asthma drug therapy
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Background: The management of mild asthma has lacked an over-the-counter (OTC) option aside from inhaled epinephrine, which is available in the United States. However, inhaled epinephrine use without an inhaled corticosteroid may increase the risk of asthma death., Objective: To compare the cost-effectiveness of OTC as-needed budesonide-formoterol as a plausible alternative to inhaled epinephrine., Methods: We developed a probabilistic Markov model to compare OTC as-needed budesonide-formoterol inhaler use vs inhaled epinephrine use in adults with mild asthma from a US societal perspective over a lifetime horizon, with a 3% annual discount rate (2022 US dollars). Inputs were derived from the SYmbicort Given as-needed in Mild Asthma (SYGMA) trials, published literature, and commercial costs. Outcomes were quality-adjusted life-years (QALY), costs, incremental net monetary benefit (INMB), severe asthma exacerbations, well-controlled asthma days, and asthma-related deaths. Microsimulation was used to evaluate underinsured Americans living with mild asthma (n = 5,250,000)., Results: Inhaled epinephrine was dominated (with lower QALYs gains at a higher cost) by both as-needed budesonide-formoterol (INMB, $15,541 at a willingness-to-pay of $100,000 per QALY) and the no-OTC inhaler option (INMB, $1023). Adults using as-needed budesonide-formoterol had 145 more well-controlled asthma days, 2.79 fewer severe exacerbations, and an absolute risk reduction of 0.23% for asthma-related death compared with inhaled epinephrine over a patient lifetime. As-needed budesonide-formoterol remained dominant in all sensitivity and scenario analyses, with a 100% probability of being cost-effective compared with inhaled epinephrine in probabilistic sensitivity analysis., Conclusion: If made available, OTC as-needed budesonide-formoterol for treating mild asthma in underinsured adults without HCP management improves asthma outcomes, prevents fatalities, and is cost-saving., Competing Interests: Disclosures Dr Shaker has participated in research that has received funding from DBV; is a member of the Joint Task Force on Practice Parameters; serves as an associated editor for Annals of Allergy, Asthma, and Immunology; and is an editorial board member for the Journal of Allergy and Clinical Immunology In Practice. Dr Greenhawt is a consultant for Aquestive; is a member of physician and medical advisory boards for DBV Technologies, Nutricia, Novartis, Aquestive, Allergy Therapeutics, AstraZeneca, ALK-Abello, Bryn, and Prota; is an unpaid member of the scientific advisory council for the National Peanut Board and the medical advisory board of the International Food Protein Induced Enterocolitis Syndrome Association; is a member of the Brighton Collaboration Criteria Vaccine Anaphylaxis 2.0 working group; is the senior associate editor for the Annals of Allergy, Asthma, and Immunology, and is member of the Joint Taskforce on Allergy Practice Parameters. Dr Sadatsafavi has received honoraria from GlaxoSmithKline and AstraZeneca for unrelated activities; and received funding from AstraZeneca and GlaxoSmithKline for unrelated projects. Dr Abrams is an employee of the Public Health Agency of Canada. Dr Oppenheimer is a consultant for Amgen, Aimmune, Aquestive, GSK, and Sanofi; is a member of the Adjudication or Data Safety Monitoring Board for AstraZeneca, Amgen, Abbvie, Novartis, and GlaxoSmithKline; is the Executive Editor for the Annals of Allergy Asthma and Immunology; and is a reviewer for UpToDate. Dr Mosnaim receives current research grant support from GlaxoSmithKline, Novartis, and Sanofi-Regeneron; and has received past research grant support from AstraZeneca, ALK-Abello, Teva, and Genentech. The remaining authors have no conflicts of interest to report., (Copyright © 2023 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)
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- 2024
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7. Effectiveness of a Maintenance and Reliever Digihaler System in Asthma: 24-Week Randomized Study (CONNECT2).
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Mosnaim GS, Hoyte FCL, Safioti G, Brown R, Hill TD, Li T, Sagalovich K, DePietro M, and Wechsler ME
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- Humans, Budesonide therapeutic use, Formoterol Fumarate therapeutic use, Ethanolamines therapeutic use, Drug Combinations, Albuterol therapeutic use, Administration, Inhalation, Bronchodilator Agents therapeutic use, Anti-Asthmatic Agents therapeutic use, Asthma drug therapy
- Abstract
Background: Digital health tools have been shown to help address challenges in asthma control, including inhaler technique, treatment adherence, and short-acting β
2 -agonist overuse. The maintenance and reliever Digihaler System (DS) comprises 2 Digihaler inhalers (fluticasone propionate/salmeterol and albuterol) with an associated patient App and web-based Dashboard. Clinicians can review patients' inhaler use and Digihaler inhalation parameter data to support clinical decision-making., Objective: CONNECT2 evaluated asthma control in participants using the DS versus standard-of-care (SoC) maintenance and reliever inhalers., Methods: Participants (13 years or older) with uncontrolled asthma (Asthma Control Test [ACT] score <19) were randomized 4:3 (open-label) to the DS (n = 210) or SoC (n = 181) for 24 weeks. The primary endpoint was the proportion of patients achieving well-controlled asthma (ie, an ACT score ≥20 or increase from baseline of ≥3 units at week 24)., Results: There was an 88.7% probability that participants using the DS would have greater odds of achieving improvement in asthma control compared with SoC after 24 weeks. The mean odds ratio (95% credible interval) for DS versus SoC was 1.35 (0.846-2.038), indicating a 35% higher odds of improved asthma control with the DS. The DS group had more clinician-participant interactions versus SoC, mainly addressing a poor inhaler technique. DS participants' maintenance treatment adherence was good (month 1: 79.2%; month 6: 68.6%); reliever use decreased by 38.2% versus baseline. App and Dashboard usability was rated "good.", Conclusion: The positive results in asthma control in this study after 24 weeks demonstrate the effectiveness of the DS in asthma management., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)- Published
- 2024
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8. Erratum for Gebo et al., "Early antibody treatment, inflammation, and risk of post-COVID conditions".
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Gebo KA, Heath SL, Fukuta Y, Zhu X, Baksh S, Abraham AG, Habtehyimer F, Shade D, Ruff J, Ram M, Laeyendecker O, Fernandez RE, Patel EU, Baker OR, Shoham S, Cachay ER, Currier JS, Gerber JM, Meisenberg B, Forthal DN, Hammitt LL, Huaman MA, Levine A, Mosnaim GS, Patel B, Paxton JH, Raval JS, Sutcliffe CG, Anjan S, Gniadek T, Kassaye S, Blair JE, Lane K, McBee NA, Gawad AL, Das P, Klein SL, Pekosz A, Bloch EM, Hanley D, Casadevall A, Tobian AAR, and Sullivan DJ
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- 2024
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9. COVID-19 convalescent plasma therapy decreases inflammatory cytokines: a randomized controlled trial.
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Habtehyimer F, Zhu X, Redd AD, Gebo KA, Abraham AG, Patel EU, Laeyendecker O, Gniadek TJ, Fernandez RE, Baker OR, Ram M, Cachay ER, Currier JS, Fukuta Y, Gerber JM, Heath SL, Meisenberg B, Huaman MA, Levine AC, Shenoy A, Anjan S, Blair JE, Cruser D, Forthal DN, Hammitt LL, Kassaye S, Mosnaim GS, Patel B, Paxton JH, Raval JS, Sutcliffe CG, Abinante M, Oei KS, Cluzet V, Cordisco ME, Greenblatt B, Rausch W, Shade D, Gawad AL, Klein SL, Pekosz A, Shoham S, Casadevall A, Bloch EM, Hanley D, Tobian AAR, and Sullivan DJ
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- Humans, COVID-19 Serotherapy, Interleukin-6, SARS-CoV-2, Cytokines, Immunization, Passive, COVID-19 therapy
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Importance: This study examined the role that cytokines may have played in the beneficial outcomes found when outpatient individuals infected with SARS-CoV-2 were transfused with COVID-19 convalescent plasma (CCP) early in their infection. We found that the pro-inflammatory cytokine IL-6 decreased significantly faster in patients treated early with CCP. Participants with COVID-19 treated with CCP later in the infection did not have the same effect. This decrease in IL-6 levels after early CCP treatment suggests a possible role of inflammation in COVID-19 progression. The evidence of IL-6 involvement brings insight into the possible mechanisms involved in CCP treatment mitigating SARS-CoV-2 severity.
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- 2024
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10. Outpatient COVID-19 convalescent plasma recipient antibody thresholds correlated to reduced hospitalizations within a randomized trial.
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Park HS, Yin A, Barranta C, Lee JS, Caputo CA, Sachithanandham J, Li M, Yoon S, Sitaras I, Jedlicka A, Eby Y, Ram M, Fernandez RE, Baker OR, Shenoy AG, Mosnaim GS, Fukuta Y, Patel B, Heath SL, Levine AC, Meisenberg BR, Spivak ES, Anjan S, Huaman MA, Blair JE, Currier JS, Paxton JH, Gerber JM, Petrini JR, Broderick PB, Rausch W, Cordisco ME, Hammel J, Greenblatt B, Cluzet VC, Cruser D, Oei K, Abinante M, Hammitt LL, Sutcliffe CG, Forthal DN, Zand MS, Cachay ER, Raval JS, Kassaye SG, Marshall CE, Yarava A, Lane K, McBee NA, Gawad AL, Karlen N, Singh A, Ford DE, Jabs DA, Appel LJ, Shade DM, Lau B, Ehrhardt S, Baksh SN, Shapiro JR, Ou J, Na YB, Knoll MD, Ornelas-Gatdula E, Arroyo-Curras N, Gniadek TJ, Caturegli P, Wu J, Ndahiro N, Betenbaugh MJ, Ziman A, Hanley DF, Casadevall A, Shoham S, Bloch EM, Gebo KA, Tobian AAR, Laeyendecker O, Pekosz A, Klein SL, and Sullivan DJ
- Abstract
Background: The COVID-19 convalescent plasma (CCP) viral specific antibody levels that translate into recipient post-transfusion antibody levels sufficient to prevent disease progression is not defined., Methods: This secondary analysis correlated donor and recipient antibody levels to hospitalization risk among unvaccinated, seronegative CCP recipients within the outpatient, double blind, randomized clinical trial that compared CCP to control plasma. The majority of COVID-19 CCP arm hospitalizations (15/17, 88%) occurred in this unvaccinated, seronegative subgroup. A functional cutoff to delineate recipient high versus low post-transfusion antibody levels was established by two methods: 1) analyzing virus neutralization-equivalent anti-S-RBD IgG responses in donors or 2) receiver operating characteristic (ROC) analysis., Results: SARS-CoV-2 anti-S-RBD IgG antibody was diluted by a factor of 21.3 into post-transfusion seronegative recipients from matched donor units. Viral specific antibody delivered approximated 1.2 mg. The high antibody recipients transfused early (symptom onset within 5 days) had no hospitalizations. A CCP recipient analysis for antibody thresholds correlated to reduced hospitalizations found a significant association with Fisher's exact test between early and high antibodies versus all other CCP recipients (or control plasma) with antibody cutoffs established by both methods-donor virus neutralization-based cutoff: (0/85; 0% versus 15/276; 5.6%) p=0.03 or ROC based cutoff: (0/94; 0% versus 15/267; 5.4%) p=0.01., Conclusion: In unvaccinated, seronegative CCP recipients, early transfusion of plasma units corresponding to the upper 30% of all study donors reduced outpatient hospitalizations. These high antibody level plasma units, given early, should be reserved for therapeutic use.Trial registration: NCT04373460., Funding: Defense Health Agency and others., Competing Interests: Conflict of Interest Statement TG-Paid consultant and employee of Fenwal, a Fresenius Kabi company; AC-Scientific Advisory Board of Sabtherapeutics (cow-derived human immunoglobulins COVID-19 treatment and other infectious diseases) and Ortho Diagnostics Speakers Bureau; MAH-contracts from Gilead Sciences, Insmed, AN2 Therapeutics, AstraZeneca to the University of Cincinnati, outside the submitted work. EB-member of the FDA Blood Products Advisory Committee; SS reports research grants; F2G, Cidara, Ansun, Zeteo: personal fees as consultant, advisory board, data safety monitoring board member; Celltrion, Adagio, Immunome, Karius, Pfizer, Scynexis, Adamis, Karyopharm, Intermountain Health: Stock options: Immunome; CS: Centers for Disease Control and Prevention, Merck, Pfizer: Research Grants. All other authors report no relevant disclosures.
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- 2023
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11. Early antibody treatment, inflammation, and risk of post-COVID conditions.
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Gebo KA, Heath SL, Fukuta Y, Zhu X, Baksh S, Abraham AG, Habtehyimer F, Shade D, Ruff J, Ram M, Laeyendecker O, Fernandez RE, Patel EU, Baker OR, Shoham S, Cachay ER, Currier JS, Gerber JM, Meisenberg B, Forthal DN, Hammitt LL, Huaman MA, Levine A, Mosnaim GS, Patel B, Paxton JH, Raval JS, Sutcliffe CG, Anjan S, Gniadek T, Kassaye S, Blair JE, Lane K, McBee NA, Gawad AL, Das P, Klein SL, Pekosz A, Bloch EM, Hanley D, Casadevall A, Tobian AAR, and Sullivan DJ
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- Humans, SARS-CoV-2, COVID-19 Serotherapy, Antibodies, Inflammation, Post-Acute COVID-19 Syndrome, COVID-19
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Importance: Approximately 20% of individuals infected with SARS-CoV-2 experienced long-term health effects, as defined PCC. However, it is unknown if there are any early biomarkers associated with PCC or whether early intervention treatments may decrease the risk of PCC. In a secondary analysis of a randomized clinical trial, this study demonstrates that among outpatients with SARS-CoV-2, increased IL-6 at time of infection is associated with increased odds of PCC. In addition, among individuals treated early, within 5 days of symptom onset, with COVID-19 convalescent plasma, there was a trend for decreased odds of PCC after adjusting for other demographic and clinical characteristics. Future treatment studies should be considered to evaluate the effect of early treatment and anti-IL-6 therapies on PCC development., Competing Interests: See Acknowledgments for conflicts of interest.
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- 2023
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12. Transfusion reactions associated with COVID-19 convalescent plasma in outpatient clinical trials.
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Huaman MA, Raval JS, Paxton JH, Mosnaim GS, Patel B, Anjan S, Meisenberg BR, Levine AC, Marshall CE, Yarava A, Shenoy AG, Heath SL, Currier JS, Fukuta Y, Blair JE, Spivak ES, Petrini JR, Broderick PB, Rausch W, Cordisco M, Hammel J, Greenblatt B, Cluzet VC, Cruser D, Oei K, Abinante M, Hammitt LL, Sutcliffe CG, Forthal DN, Zand MS, Cachay ER, Kassaye SG, Ram M, Wang Y, Das P, Lane K, McBee NA, Gawad AL, Karlen N, Ford DE, Laeyendecker O, Pekosz A, Klein SL, Ehrhardt S, Lau B, Baksh SN, Shade DM, Casadevall A, Hanley DF, Ou J, Gniadek TJ, Ziman A, Shoham S, Gebo KA, Bloch EM, Tobian AAR, Sullivan DJ, and Gerber JM
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- Humans, COVID-19 Serotherapy, Immunization, Passive adverse effects, Outpatients, SARS-CoV-2, Randomized Controlled Trials as Topic, COVID-19 therapy, COVID-19 etiology, Transfusion Reaction etiology, Urticaria etiology
- Abstract
Background: COVID-19 convalescent plasma (CCP) is an important therapeutic option for outpatients at high risk of hospitalization from SARS-CoV-2 infection. We assessed the safety of outpatient CCP transfusions administered during clinical trials., Study Design and Methods: We analyzed data pertaining to transfusion-related reactions from two randomized controlled trials in the U.S. that evaluated the efficacy of CCP versus control plasma in various ambulatory settings. Multivariable logistic regression was used to assess whether CCP was associated with transfusion reactions, after adjusting for potential confounders., Results: The combined study reported 79/1351 (5.9%) adverse events during the transfusion visit, with the majority 62/1351 (4.6%) characterized by mild, allergic-type findings of urticaria, and/or pruritus consistent with minor allergic transfusion reactions; the other reported events were attributed to the patients' underlying disease, COVID-19, or vasovagal in nature. We found no difference in the likelihood of allergic transfusion reactions between those receiving CCP versus control plasma (adjusted odds ratio [AOR], 0.75; 95% CI, 0.43-1.31). Risk of urticaria and/or pruritus increased with a pre-existing diagnosis of asthma (AOR, 2.33; 95% CI, 1.16-4.67). We did not observe any CCP-attributed antibody disease enhancement in participants with COVID-19 or increased risk of infection. There were no life-threatening severe transfusion reactions and no patients required hospitalization related to transfusion-associated complications., Discussion: Outpatient plasma administration was safely performed for nearly 1400 participants. CCP is a safe therapeutic option for outpatients at risk of hospitalization from COVID-19., (© 2023 The Authors. Transfusion published by Wiley Periodicals LLC on behalf of AABB.)
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- 2023
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13. Dynamics of inflammatory responses after SARS-CoV-2 infection by vaccination status in the USA: a prospective cohort study.
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Zhu X, Gebo KA, Abraham AG, Habtehyimer F, Patel EU, Laeyendecker O, Gniadek TJ, Fernandez RE, Baker OR, Ram M, Cachay ER, Currier JS, Fukuta Y, Gerber JM, Heath SL, Meisenberg B, Huaman MA, Levine AC, Shenoy A, Anjan S, Blair JE, Cruser D, Forthal DN, Hammitt LL, Kassaye S, Mosnaim GS, Patel B, Paxton JH, Raval JS, Sutcliffe CG, Abinante M, Broderick P, Cluzet V, Cordisco ME, Greenblatt B, Petrini J, Rausch W, Shade D, Lane K, Gawad AL, Klein SL, Pekosz A, Shoham S, Casadevall A, Bloch EM, Hanley D, Sullivan DJ, and Tobian AAR
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- United States epidemiology, Humans, Female, Male, Adolescent, Adult, Vascular Endothelial Growth Factor A, SARS-CoV-2, COVID-19 Vaccines, Interleukin-7, Interleukin-8, Prospective Studies, COVID-19 Serotherapy, Cytokines, COVID-19 epidemiology
- Abstract
Background: Cytokines and chemokines play a critical role in the response to infection and vaccination. We aimed to assess the longitudinal association of COVID-19 vaccination with cytokine and chemokine concentrations and trajectories among people with SARS-CoV-2 infection., Methods: In this longitudinal, prospective cohort study, blood samples were used from participants enrolled in a multi-centre randomised trial assessing the efficacy of convalescent plasma therapy for ambulatory COVID-19. The trial was conducted in 23 outpatient sites in the USA. In this study, participants (aged ≥18 years) were restricted to those with COVID-19 before vaccination or with breakthrough infections who had blood samples and symptom data collected at screening (pre-transfusion), day 14, and day 90 visits. Associations between COVID-19 vaccination status and concentrations of 21 cytokines and chemokines (measured using multiplexed sandwich immunoassays) were examined using multivariate linear mixed-effects regression models, adjusted for age, sex, BMI, hypertension, diabetes, trial group, and COVID-19 waves (pre-alpha or alpha and delta)., Findings: Between June 29, 2020, and Sept 30, 2021, 882 participants recently infected with SARS-CoV-2 were enrolled, of whom 506 (57%) were female and 376 (43%) were male. 688 (78%) of 882 participants were unvaccinated, 55 (6%) were partly vaccinated, and 139 (16%) were fully vaccinated at baseline. After adjusting for confounders, geometric mean concentrations of interleukin (IL)-2RA, IL-7, IL-8, IL-15, IL-29 (interferon-λ), inducible protein-10, monocyte chemoattractant protein-1, and tumour necrosis factor-α were significantly lower among the fully vaccinated group than in the unvaccinated group at screening. On day 90, fully vaccinated participants had approximately 20% lower geometric mean concentrations of IL-7, IL-8, and vascular endothelial growth factor-A than unvaccinated participants. Cytokine and chemokine concentrations decreased over time in the fully and partly vaccinated groups and unvaccinated group. Log
10 cytokine and chemokine concentrations decreased faster among participants in the unvaccinated group than in other groups, but their geometric mean concentrations were generally higher than fully vaccinated participants at 90 days. Days since full vaccination and type of vaccine received were not correlated with cytokine and chemokine concentrations., Interpretation: Initially and during recovery from symptomatic COVID-19, fully vaccinated participants had lower concentrations of inflammatory markers than unvaccinated participants suggesting vaccination is associated with short-term and long-term reduction in inflammation, which could in part explain the reduced disease severity and mortality in vaccinated individuals., Funding: US Department of Defense, National Institutes of Health, Bloomberg Philanthropies, State of Maryland, Mental Wellness Foundation, Moriah Fund, Octapharma, HealthNetwork Foundation, and the Shear Family Foundation., Competing Interests: Declaration of interests KAG reports consultancy work for the Aspen Institute, Teach for America, serving as a non-paid member of a scientific advisory board for Pfizer, and writing COVID-19 management guidelines for UpToDate. AGA reports consultancy work for Implementation Group, Hirslanden Klinik, and Elsevier. ERC reports receiving unrestricted research grants from Gilead and Merck paid to the Regents of the University of California and participating in an advisory board to Theratechnologies for an unrelated topic. JSC reports consultancy work for Merck and Company in 2021. TJG reports employment by Fenwal, a Fresenius Kabi Company. LLH reports research funding to Johns Hopkins Center of American Indian Health from AstraZeneca, US Centers for Disease Control and Prevention, Merck, NIH, and Pfizer. MAH reports contracts from Gilead Sciences, Insmed, and AN2 Therapeutics to the University of Cincinnati. GSM reports research grant support from Teva, Alk-Abello, Genentech, Novartis, GlaxoSmithKline, and Sanofi-Regeneron, serving as an immediate past president of the American Academy of Allergy Asthma and Immunology, and is co-chair of the Continuous Assessment Program Examination for the American Board of Allergy and Immunology. BP reports participating in part of the COVID-19 trials and pulmonary arterial hypertension trials. JHP reports research funding from MindRhythm. JSR is a consultant and advisor with Sanofi Genzyme, and a board of directors member with the American Society for Apheresis. SK reports helping to produce educational materials related to HIV with Integritas Communications and Vindico Medical Education. AC reports serving on the scientific advisory board of SAB Biotherapeutics. EMB reports personal fees and non-financial support from Terumo BCT, Abbott Laboratories, Tegus, and UptoDate, is a member of the US Food and Drug Administration Blood Products Advisory Committee, and served on a convalescent plasma guideline panel. DH reports personal fees from Neurelis, Neurotrope, and medicolegal consulting. DJS is a founder and board member with stock options (macrolide for malaria) for AliquantumRx and reports consulting for Hemex Health and royalties for malaria diagnostic test control standards to Alere. SLH reports serving on the data monitoring committee for Pfizer. All other authors declare no competing interests., (Copyright © 2023 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license. Published by Elsevier Ltd.. All rights reserved.)- Published
- 2023
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14. Coordinated Health Care Interventions for Childhood Asthma Gaps in Outcomes (CHICAGO) plan.
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Krishnan JA, Margellos-Anast H, Kumar R, Africk JJ, Berbaum M, Bracken N, Chen YF, DeLisa J, Erwin K, Ignoffo S, Illendula SD, Kim H, Lohff C, MacTavish T, Martin MA, Mosnaim GS, Nguyen H, Norell S, Nyenhuis SM, Paik SM, Pittsenbarger Z, Press VG, Sculley J, Thompson TM, Zun L, Gerald LB, and McDermott M
- Abstract
Background: Evidence-based strategies to improve outcomes in minority children with uncontrolled asthma discharged from the emergency department (ED) are needed., Objectives: This multicenter pragmatic clinical trial was designed to compare an ED-only intervention (decision support tool), an ED-only intervention and home visits by community health workers for 6 months (ED-plus-home), and enhanced usual care (UC)., Methods: Children aged 5 to 11 years with uncontrolled asthma were enrolled. The change over 6 months in the Patient-Reported Outcomes Measurement Information System Asthma Impact Scale score in children and Satisfaction with Participation in Social Roles score in caregivers were the primary outcomes. The secondary outcomes included guideline-recommended ED discharge care and self-management., Results: Recruitment was significantly lower than expected (373 vs 640 expected). Of the 373 children (64% Black and 31% Latino children), only 63% completed the 6-month follow-up visit. In multivariable analyses that accounted for missing data, the adjusted odds ratios and 98% CIs for differences in Asthma Impact Scores or caregivers' Satisfaction with Participation in Social Roles scores were not significant. However, guideline-recommended ED discharge care was significantly improved in the intervention groups versus in the UC group, and self-management behaviors were significantly improved in the ED-plus-home group versus in the ED-only and UC groups., Conclusions: The ED-based interventions did not significantly improve the primary clinical outcomes, although the study was likely underpowered. Although guideline-recommended ED discharge care and self-management did improve, their effect on clinical outcomes needs further study., Competing Interests: In the past 12 months, J. Krishnan has received research funding from the National Institutes of Health/National Heart, Lung and Blood Institute (NIH/NHLBI), the American Lung Association, and the Patient-Centered Outcomes Institute, as well as consulting fees from GlaxoSmithKline, the American Thoracic Society, and BData Inc. G. Mosnaim currently receives research grant support from GlaxoSmithKline, Novartis, Sanofi-Regneron, and Teva, and in the past 12 months she has received research grant support from Astra-Zeneca, Alk-Abelló and Genentech. In the past 12 months, L. Gerald has received research funding from the NIH/NHLBI, the American Lung Association, the US Centers for Disease Control and Prevention, the Robert Wood Johnson Foundation, the Patient-Centered Outcomes Institute, and the Southwest Environmental Health Sciences Center, as well as consulting fees from Up-to-Date. V. Press reports receiving funding from the National Institutes of Health (grant R01HL146644) and the Agency for Health Care Research and Quality (grant R01HS027804) as well as consultant fees from Vizient, Inc, and Humana. S. M. Nyenhuis receives funding from the National Institutes of Health, royalties from Wolters/Kluwer and Springer, and consultant fees from PRIME Education. The rest of the authors declare that they have no relevant conflicts of interest.
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- 2023
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15. The One Health approach for allergic diseases and asthma.
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Jutel M, Mosnaim GS, Bernstein JA, Del Giacco S, Khan DA, Nadeau KC, Pali-Schöll I, Torres MJ, Zemelka-Wiacek M, and Agache I
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- Animals, Humans, Irritants, Allergens, One Health, Hypersensitivity epidemiology, Hypersensitivity etiology, Hypersensitivity therapy, Asthma epidemiology, Asthma etiology, Asthma therapy
- Abstract
The One Health approach is a collaborative and interdisciplinary strategy with focal point on human, animal, and environmental health interconnections. One Health can support the advanced management of allergic diseases and asthma, as complex, multifactorial diseases driven by interactions between the resilience response to the exposome. According to the One Health concept allergic diseases and asthma arising from exposures to a wide range of allergens, infectious agents and irritants (such as pollutants) occurring indoors and outdoors can be heavily influenced by environmental health (air, water, and soil quality) intermingled with animal health. These are currently heavily impacted by climate change, land use, urbanization, migration, overpopulation, and many more. Thus, a coordinated response to address the underlying factors that contribute to the development of allergic diseases and asthma needs to focus on the environment, human, and animal health altogether. Collaborative efforts across multiple sectors, including public health, veterinary medicine, environmental science, and community engagement are thus needed. A wide range of activities, including monitoring and surveillance of environmental and health data, targeted interventions to reduce exposures to allergens and irritants, and research on the underlying mechanisms that drive the development of allergic diseases and asthma are needed to move the field forward. In this consensus document elaborated by the European Academy of Allergy and Clinical Immunology (EAACI) and American Academy of Allergy, Asthma, and Immunology (AAAAI) under the practical allergy (PRACTALL) series, we provide insights into the One Heath approach aiming to provide a framework for addressing the complex and multifactorial nature of allergic diseases and asthma., (© 2023 European Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd.)
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- 2023
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16. Early Treatment, Inflammation and Post-COVID Conditions.
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Gebo KA, Heath SL, Fukuta Y, Zhu X, Baksh S, Abraham AG, Habtehyimer F, Shade D, Ruff J, Ram M, Laeyendecker O, Fernandez RE, Patel EU, Baker OR, Shoham S, Cachay ER, Currier JS, Gerber JM, Meisenberg B, Forthal DN, Hammitt LL, Huaman MA, Levine A, Mosnaim GS, Patel B, Paxton JH, Raval JS, Sutcliffe CG, Anjan S, Gniadek T, Kassaye S, Blair JE, Lane K, McBee NA, Gawad AL, Das P, Klein SL, Pekosz A, Casadevall A, Bloch EM, Hanley D, Tobian AAR, and Sullivan DJ
- Abstract
Background: Post-COVID conditions (PCC) are common and have significant morbidity. Risk factors for PCC include advancing age, female sex, obesity, and diabetes mellitus. Little is known about early treatment, inflammation, and PCC., Methods: Among 883 individuals with confirmed SARS-CoV-2 infection participating in a randomized trial of CCP vs. control plasma with available biospecimens and symptom data, the association between early COVID treatment, cytokine levels and PCC was evaluated. Cytokine and chemokine levels were assessed at baseline, day 14 and day 90 using a multiplexed sandwich immuosassay (Mesoscale Discovery). Presence of any self-reported PCC symptoms was assessed at day 90. Associations between COVID treatment, cytokine levels and PCC were examined using multivariate logistic regression models., Results: One-third of the 882 participants had day 90 PCC symptoms, with fatigue (14.5%) and loss of smell (14.5%) being most common. Cytokine levels decreased from baseline to day 90. In a multivariable analysis including diabetes, body mass index, race, and vaccine status, female sex (adjusted odds ratio[AOR]=2.70[1.93-3.81]), older age (AOR=1.32[1.17-1.50]), and elevated baseline levels of IL-6 (AOR=1.59[1.02-2.47]) were associated with development of PCC.There was a trend for decreased PCC in those with early CCP treatment (≤5 days after symptom onset) compared to late CCP treatment., Conclusion: Increased IL-6 levels were associated with the development of PCC and there was a trend for decreased PCC with early CCP treatment in this predominately unvaccinated population. Future treatment studies should evaluate the effect of early treatment and anti-IL-6 therapies on PCC development., Competing Interests: Conflicts of Interest: Kelly Gebo- Consults for the Aspen Institute, Teach for America, served as a non-paid member of scientific advisory board for Pfizer and writes COVID management guidelines for UpToDate which are out of scope of paper. Sonya L. Heath- Nothing to disclose Yuriko Fukuta- Nothing to disclose Xianming Zhu- Nothing to disclose Sheriza Baksh- Nothing to disclose Alison G. Abraham- Consultant for Implementation Group Inc, Hirslanden Klinik, Zurich CH, & ELSEVIER, Feben Habtehyimer- Nothing to disclose David Shade- Nothing to disclose Jessica Ruff- Nothing to disclose Malathi Ram- Nothing to disclose Oliver Laeyendecker- Nothing to disclose Reinaldo E. Fernandez- Nothing to disclose Eshan U. Patel- Nothing to disclose Owen R. Baker- Nothing to disclose Shmuel Shoham- Served on a CCP guideline panel Edward R. Cachay- has received unrestricted research grants from Gilead and Merck paid to the Regents of the University of California. He also participated in an advisory board to Theratechnologies for an unrelated topic. Judith S. Currier- Consulted for Merck and Company in 2021, currently not on any guidelines panel Jonathan M. Gerber- Nothing to disclose Thomas J. Gniadek- Currently employed by Fenwal, Inc., a Fresenius Kabi Company. Barry Meisenberg- Nothing to disclose Donald N. Forthal- nothing to disclose Laura L. Hammitt- research funding to my institution from AstraZeneca, CDC, Merck, NIH, and Pfizer. Moises A. Huaman- M.A.H. reports contracts from Gilead Sciences Inc, Insmed Inc, AN2 Therapeutics, Inc to the University of Cincinnati, outside the submitted work. Adam Levine- Nothing to disclose Giselle S. Mosnaim- Received research grant support from Teva, Alk-Abello, and Genentech and currently receives research grant support from Novartis, GlaxoSmithKline, and Sanofi-Regeneron. Serves as Immediate Past President of the American Academy of Allergy Asthma and Immunology and Co-Chair of the Continuous Assessment Program Examination for the American Board of Allergy and Immunology Bela Patel- Part of COVID trials and PAH trials, no disclosures relevant to CP James H. Paxton- Research funding from MindRhythm, Inc Jay S. Raval- Consultant and Advisor with Sanofi Genzyme; Board of Directors Member with the American Society for Apheresis, no overlap with CP Catherine G. Sutcliffe- Nothing to disclose Shweta Anjan- Nothing to disclose Seble Kassaye- Helped to produce educational materials related to HIV with Integritas Communications, LLC and Vindico Medical Education, LLC Janis E. Blair- Nothing to disclose Karen Lane- nothing to disclose Nichol A. McBee- Nothing to disclose Amy L. Gawad- Nothing to disclose Piyali Das- Nothing to disclose Sabra L. Klein- Nothing to disclose Andrew Pekosz- Nothing to disclose Arturo Casadevall- Serve on the scientific advisory board of SAB Therapeutics Evan M. Bloch- EMB reports personal fees and non-financial support from Terumo BCT, Abbott Laboratories, Tegus and UptoDate, outside of the submitted work. EMB is a member of the United States Food and Drug Administration (FDA) Blood Products Advisory Committee. Served on a CCP guideline panel Daniel Hanley- Dr. Hanley reports personal fees from Neurelis, Neurotrope, and medicolegal consulting. Aaron A.R. Tobian- Served on a CCP guideline panel David J. Sullivan- Founder and Board member with stock options (macrolide for malaria) DJS reports AliquantumRx, Hemex Health malaria diagnostics consulting and royalties for malaria diagnostic test control standards to Alere- all outside of submitted work
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- 2023
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17. Do regional geography and race influence management of chronic spontaneous urticaria?
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Mosnaim GS, Greenhawt M, Imas P, Au L, Mehlis S, Oppenheimer J, Lang D, Bernstein J, and Shaker M
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- Humans, Geography, Chicago, Chronic Urticaria drug therapy
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Chronic spontaneous urticaria is defined as migratory evanescent pruritic blanching wheals that occur with variable frequency for 6 weeks or more, with or without accompanying angioedema. This condition affects approximately 0.1% to 1.4% of persons worldwide. Second-generation H1 antihistamines are the mainstay of management, with refractory cases often managed with an array of options, including H2 antihistamines, leukotriene receptor antagonists, glucocorticosteroids, immunosuppressive agents, and omalizumab. However, the degree of practice variation as to what treatments are prescribed is poorly understood, given that clinical care could be driven by patient preferences or lack of clarity as to best practices for refractory cases. We conducted a small, exploratory study of the role of race, ethnicity, and regional geographic distance to specialist care on chronic spontaneous urticaria prescribing practices. A small-area geographic variation in chronic spontaneous urticaria management in a large Chicago-area health care system was identified. Rates of omalizumab use varied by patient zip code, with more omalizumab prescriptions being associated with zip codes closer to the main office of an academic medical center-affiliated allergist-immunologist practice. Higher rates of omalizumab use were associated with White race in regional and patient-level analyses, though the reasons for this race-based finding are not clear., (Copyright © 2022 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)
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- 2022
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18. Improving Adherence in Urban Youth With Asthma: Role of Community Health Workers.
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Pappalardo AA, Martin MA, Weinstein S, Pugach O, and Mosnaim GS
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- Child, Adolescent, Humans, Child, Preschool, Community Health Workers, Adrenal Cortex Hormones therapeutic use, Nebulizers and Vaporizers, Hispanic or Latino, Administration, Inhalation, Medication Adherence, Asthma drug therapy, Asthma epidemiology, Anti-Asthmatic Agents therapeutic use
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Background: The Asthma Action at Erie Trial is a comparative effectiveness trial comparing a community health worker (CHW) versus certified asthma educator (AE-C) intervention in low-income minority children., Objectives: Determine whether asthma medication possession, adherence, technique, and triggers differ in children receiving an asthma CHW compared with an AE-C intervention., Methods: Children with uncontrolled asthma were randomized to receive 10 CHW home visits or 2 AE-C sessions in a clinic over 1 year. Asthma medication possession and inhaler technique were observed; adherence was measured using self-report, dose counters, and electronic monitors. Environmental triggers were captured by self-report, observation, and objective measurement. Mixed effects linear and logistic regression models were estimated for continuous and binary outcomes., Results: Children (n = 223) were mainly Hispanic (85%) and ages 5 to 16 years. Quick-relievers (82%), spacers (72%), and inhaled corticosteroid (ICS)-containing medications (44%) were tracked. Of those with uncontrolled asthma, 35% lacked an ICS prescription (n = 201). Children in the CHW arm were more likely to have an ICS prescription at 12 months (odds ratio 2.39; 95% CI 0.99-5.79). Inhaler technique improved 9.8% in the CHW arm at 6 months (95% CI 4.20-15.32). The ICS adherence improved in the CHW arm at 12 months, with a 16.0% (95% CI 2.3-29.7; P = .02) difference between arms. Differences in trigger exposure over time were not observed between arms., Conclusions: The CHW services were associated with improved ICS adherence and inhaler technique, compared with AE-C services. More information is needed to determine the necessary dosage of intervention to sustain adherence., (Copyright © 2022 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)
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- 2022
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19. Digital Inhalers and Remote Patient Monitoring for Asthma.
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Mosnaim GS, Greiwe J, Jariwala SP, Pleasants R, and Merchant R
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- Administration, Inhalation, Adrenal Cortex Hormones therapeutic use, Humans, Medication Adherence, Monitoring, Physiologic, Nebulizers and Vaporizers, Anti-Asthmatic Agents therapeutic use, Asthma diagnosis, Asthma drug therapy, Biological Products therapeutic use
- Abstract
Digital inhaler systems, remote patient monitoring, and remote therapeutic monitoring offer great promise as diagnostic tools and therapeutic interventions to improve adherence and inhaler technique for patients with difficult-to-control asthma. In turn, improvements in adherence and inhaler technique may translate into decreasing the need for high side effect treatments such as oral corticosteroids and costly therapies including biologics. Although more clinical trials are needed, studies that use digital inhaler systems to collect objective real-time data on medication-taking behavior via electronic medication monitors and feed this data back to patients on their mobile asthma app, and to health care professionals on the clinician dashboard to counsel patients, show positive outcomes. This article addresses the use of these diagnostic and therapeutic tools in asthma care, how to choose a digital inhaler system, how to teach patients to use the system, strategies for the adoption of these technologies in large health care systems as well as smaller practices, coding and reimbursement, liability concerns, and research gaps., (Copyright © 2022 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)
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- 2022
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20. Electronic medication monitoring versus self-reported use of inhaled corticosteroids and short-acting beta 2 -agonists in uncontrolled asthma.
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Mosnaim GS, Stempel DA, Gonzalez C, Adams B, BenIsrael-Olive N, Gondalia R, Kaye L, Shalowitz M, and Szefler S
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- Adult, Female, Humans, Male, Middle Aged, Administration, Inhalation, Adrenal Cortex Hormones therapeutic use, Electronics, Self Report, Asthma drug therapy
- Abstract
Objective: Current standard of care, patient self-report and clinician estimation, overestimates true inhaled corticosteroids (ICS) adherence. We compare self-reported inhaled ICS and short-acting beta 2-agonists (SABA) use with objective data from electronic medication monitors (EMMs)., Methods: Adults with uncontrolled asthma and prescribed ICS and SABA were enrolled. At visit one, participants' ICS and SABA inhalers were fitted with EMMs to track real-time medication usage over 14 days. Participants were asked to complete paper diaries to self-report medication usage over the same period. Participant self-report of ICS adherence and SABA use versus objective ICS adherence and SABA use was compared using Wilcoxon signed-rank tests., Results: One hundred participants (80% female, mean age 48.5 years, 60% completed college, 80% privately insured) had complete data. Participant self-report (median (IQR): 0.8 (0.0, 2.0)) was greater than objectively measured (median (IQR): 0.43 (0.1, 2.1)) SABA use, but the difference was not statistically significant ( P = 0.64). Participant self-report (median (IQR): 97 (67, 100)) was significantly greater than objectively measured (median (IQR): 75 (54, 93)) ICS adherence ( P = 0.002)., Conclusions: Significant discrepancies between self-report and objective ICS usage were observed. EMM can provide clinicians with accurate data on ICS medication taking behavior, thus reducing medication regimen complexity, side effects, and costs.
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- 2022
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21. Effectiveness of a Digital Inhaler System for Patients With Asthma: A 12-Week, Open-Label, Randomized Study (CONNECT1).
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Hoyte FCL, Mosnaim GS, Rogers L, Safioti G, Brown R, Li T, DePietro M, Reich M, Hill TD, and Wechsler ME
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- Administration, Inhalation, Albuterol therapeutic use, Bayes Theorem, Humans, Nebulizers and Vaporizers, Asthma drug therapy, Bronchodilator Agents therapeutic use
- Abstract
Background: The albuterol Digihaler (albuterol 90 μg/dose) transmits data wirelessly to a smart device application, which synchronizes with a Digital Health Platform to store and transfer data to a web-based Dashboard. The Reliever Digihaler System (RDS) comprises the albuterol Digihaler, application, Digital Health Platform and Dashboard. This allows patients and health care professionals to review reliever inhaler usage and inhalation quality to aid clinical decision making., Objective: To demonstrate the effectiveness, as measured by change in asthma control, of the RDS compared with standard of care., Methods: In this 12-week study, participants aged 13 years or older with suboptimal asthma control (Asthma Control Test [ACT] score < 19) were randomized to use either RDS or standard of care albuterol reliever inhalers. The health care professionals were recommended at study start to check each participant's inhalation data (including inhalation quantity and quality parameters) 1 or more times per week. Primary outcome was the proportion of participants achieving clinically meaningful improvement in asthma control (ACT score ≥ 20 at week 12 and/or increase ≥ 3 units from baseline). Bayesian statistical analysis provided a posterior probability distribution for odds ratios with corresponding credible intervals., Results: Participants using the RDS (n = 167) had an 85.3% probability of greater odds of clinically meaningful asthma control improvements than those using SoC (n = 166) after 3 months (mean odds ratio 1.33; 95% credible interval 0.813-2.050)., Conclusions: In this study, participants using the RDS had greater odds of clinically meaningful improvements in asthma control versus SoC after 3 months. Further investigation of the potential of the RDS to help improve asthma management is warranted., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)
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- 2022
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22. Early Outpatient Treatment for Covid-19 with Convalescent Plasma.
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Sullivan DJ, Gebo KA, Shoham S, Bloch EM, Lau B, Shenoy AG, Mosnaim GS, Gniadek TJ, Fukuta Y, Patel B, Heath SL, Levine AC, Meisenberg BR, Spivak ES, Anjan S, Huaman MA, Blair JE, Currier JS, Paxton JH, Gerber JM, Petrini JR, Broderick PB, Rausch W, Cordisco ME, Hammel J, Greenblatt B, Cluzet VC, Cruser D, Oei K, Abinante M, Hammitt LL, Sutcliffe CG, Forthal DN, Zand MS, Cachay ER, Raval JS, Kassaye SG, Foster EC, Roth M, Marshall CE, Yarava A, Lane K, McBee NA, Gawad AL, Karlen N, Singh A, Ford DE, Jabs DA, Appel LJ, Shade DM, Ehrhardt S, Baksh SN, Laeyendecker O, Pekosz A, Klein SL, Casadevall A, Tobian AAR, and Hanley DF
- Subjects
- Adult, Ambulatory Care, Disease Progression, Double-Blind Method, Hospitalization, Humans, Treatment Outcome, United States, COVID-19 Serotherapy, COVID-19 therapy, Immunization, Passive adverse effects, Immunization, Passive methods
- Abstract
Background: Polyclonal convalescent plasma may be obtained from donors who have recovered from coronavirus disease 2019 (Covid-19). The efficacy of this plasma in preventing serious complications in outpatients with recent-onset Covid-19 is uncertain., Methods: In this multicenter, double-blind, randomized, controlled trial, we evaluated the efficacy and safety of Covid-19 convalescent plasma, as compared with control plasma, in symptomatic adults (≥18 years of age) who had tested positive for severe acute respiratory syndrome coronavirus 2, regardless of their risk factors for disease progression or vaccination status. Participants were enrolled within 8 days after symptom onset and received a transfusion within 1 day after randomization. The primary outcome was Covid-19-related hospitalization within 28 days after transfusion., Results: Participants were enrolled from June 3, 2020, through October 1, 2021. A total of 1225 participants underwent randomization, and 1181 received a transfusion. In the prespecified modified intention-to-treat analysis that included only participants who received a transfusion, the primary outcome occurred in 17 of 592 participants (2.9%) who received convalescent plasma and 37 of 589 participants (6.3%) who received control plasma (absolute risk reduction, 3.4 percentage points; 95% confidence interval, 1.0 to 5.8; P = 0.005), which corresponded to a relative risk reduction of 54%. Evidence of efficacy in vaccinated participants cannot be inferred from these data because 53 of the 54 participants with Covid-19 who were hospitalized were unvaccinated and 1 participant was partially vaccinated. A total of 16 grade 3 or 4 adverse events (7 in the convalescent-plasma group and 9 in the control-plasma group) occurred in participants who were not hospitalized., Conclusions: In participants with Covid-19, most of whom were unvaccinated, the administration of convalescent plasma within 9 days after the onset of symptoms reduced the risk of disease progression leading to hospitalization. (Funded by the Department of Defense and others; CSSC-004 ClinicalTrials.gov number, NCT04373460.)., (Copyright © 2022 Massachusetts Medical Society.)
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- 2022
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23. How do I implement an outpatient program for the administration of convalescent plasma for COVID-19?
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Bloch EM, Tobian AAR, Shoham S, Hanley DF, Gniadek TJ, Cachay ER, Meisenberg BR, Kafka K, Marshall C, Heath SL, Shenoy A, Paxton JH, Levine A, Forthal D, Fukuta Y, Huaman MA, Ziman A, Adamski J, Gerber J, Cruser D, Kassaye SG, Mosnaim GS, Patel B, Metcalf RA, Anjan S, Reisler RB, Yarava A, Lane K, McBee N, Gawad A, Raval JS, Zand M, Abinante M, Broderick PB, Casadevall A, Sullivan D, and Gebo KA
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- Humans, Immunization, Passive, Outpatients, Pandemics, SARS-CoV-2, United States, COVID-19 Serotherapy, COVID-19 therapy
- Abstract
Convalescent plasma, collected from donors who have recovered from a pathogen of interest, has been used to treat infectious diseases, particularly in times of outbreak, when alternative therapies were unavailable. The COVID-19 pandemic revived interest in the use of convalescent plasma. Large observational studies and clinical trials that were executed during the pandemic provided insight into how to use convalescent plasma, whereby high levels of antibodies against the pathogen of interest and administration early within the time course of the disease are critical for optimal therapeutic effect. Several studies have shown outpatient administration of COVID-19 convalescent plasma (CCP) to be both safe and effective, preventing clinical progression in patients when administered within the first week of COVID-19. The United States Food and Drug Administration expanded its emergency use authorization (EUA) to allow for the administration of CCP in an outpatient setting in December 2021, at least for immunocompromised patients or those on immunosuppressive therapy. Outpatient transfusion of CCP and infusion of monoclonal antibody therapies for a highly transmissible infectious disease introduces nuanced challenges related to infection prevention. Drawing on our experiences with the clinical and research use of CCP, we describe the logistical considerations and workflow spanning procurement of qualified products, infrastructure, staffing, transfusion, and associated management of adverse events. The purpose of this description is to facilitate the efforts of others intent on establishing outpatient transfusion programs for CCP and other antibody-based therapies., (© 2022 AABB.)
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- 2022
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24. Randomized Controlled Trial of Early Outpatient COVID-19 Treatment with High-Titer Convalescent Plasma.
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Sullivan DJ, Gebo KA, Shoham S, Bloch EM, Lau B, Shenoy AG, Mosnaim GS, Gniadek TJ, Fukuta Y, Patel B, Heath SL, Levine AC, Meisenberg BR, Spivak ES, Anjan S, Huaman MA, Blair JE, Currier JS, Paxton JH, Gerber JM, Petrini JR, Broderick PB, Rausch W, Cordisco ME, Hammel J, Greenblatt B, Cluzet VC, Cruser D, Oei K, Abinante M, Hammitt LL, Sutcliffe CG, Forthal DN, Zand MS, Cachay ER, Raval JS, Kassaye SG, Foster EC, Roth M, Marshall CE, Yarava A, Lane K, McBee NA, Gawad AL, Karlen N, Singh A, Ford DE, Jabs DA, Appel LJ, Shade DM, Ehrhardt S, Baksh SN, Laeyendecker O, Pekosz A, Klein SL, Casadevall A, Tobian AAR, and Hanley DF
- Abstract
Background: The efficacy of polyclonal high titer convalescent plasma to prevent serious complications of COVID-19 in outpatients with recent onset of illness is uncertain., Methods: This multicenter, double-blind randomized controlled trial compared the efficacy and safety of SARS-CoV-2 high titer convalescent plasma to placebo control plasma in symptomatic adults ≥18 years positive for SARS-CoV-2 regardless of risk factors for disease progression or vaccine status. Participants with symptom onset within 8 days were enrolled, then transfused within the subsequent day. The measured primary outcome was COVID-19-related hospitalization within 28 days of plasma transfusion. The enrollment period was June 3, 2020 to October 1, 2021., Results: A total of 1225 participants were randomized and 1181 transfused. In the pre-specified modified intention-to-treat analysis that excluded those not transfused, the primary endpoint occurred in 37 of 589 (6.3%) who received placebo control plasma and in 17 of 592 (2.9%) participants who received convalescent plasma (relative risk, 0.46; one-sided 95% upper bound confidence interval 0.733; P=0.004) corresponding to a 54% risk reduction. Examination with a model adjusting for covariates related to the outcome did not change the conclusions., Conclusion: Early administration of high titer SARS-CoV-2 convalescent plasma reduced outpatient hospitalizations by more than 50%. High titer convalescent plasma is an effective early outpatient COVID-19 treatment with the advantages of low cost, wide availability, and rapid resilience to variant emergence from viral genetic drift in the face of a changing pandemic., Trial Registration: ClinicalTrials.gov number, NCT04373460.
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- 2021
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25. Psychosocial Moderators and Outcomes of a Randomized Effectiveness Trial for Child Asthma.
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Weinstein SM, Pugach O, Rosales G, Mosnaim GS, Orozco K, Pappalardo AA, and Martin MA
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- Adolescent, Child, Family, Hispanic or Latino, Humans, Social Support, Asthma therapy, Stress Disorders, Post-Traumatic
- Abstract
Objective: Psychosocial factors play a role in child asthma morbidity and disparities, but their impact on asthma intervention effectiveness is less understood. This study examined how child, parent, and family psychosocial factors moderated asthma response to, and changed in response to, 2 community asthma interventions among urban minority youth., Methods: Asthma Action at Erie was a randomized comparative effectiveness trial examining a community health worker (CHW) home intervention versus certified asthma educator (AE-C) services for children aged 5-16 with uncontrolled asthma (N = 223; mean age = 9.37, SD = 3.02; 85.2% Hispanic). Asthma control was assessed via the Asthma Control Test (ACT)/childhood ACT and activity limitation. Baseline child/parent depression and posttraumatic stress disorder (PTSD) symptoms, family chaos, and social support were examined as treatment moderators. We also tested intervention effects on psychosocial outcomes., Results: For parents with higher baseline depression symptoms, youth in the CHW group had greater ACT improvement by 24 months (7.49 points) versus AE-C (4.76 points) and 51% reduction in days of limitation by 6 months versus AE-C (ß = -0.118; p = .0145). For higher parent PTSD symptoms, youth in CHW had 68% fewer days of limitation at 24 months versus AE-C (ß = -0.091; p = .0102). Psychosocial outcomes did not vary by group, but parent depression, parent and child PTSD symptoms, and social support improved for all., Conclusions: CHW intervention was associated with improved asthma control among families with higher parent strain. Findings have implications for utilizing tailored CHW home interventions to optimize asthma outcomes in at-risk families., (© The Author(s) 2021. Published by Oxford University Press on behalf of the Society of Pediatric Psychology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
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- 2021
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26. The Impact of Patient Self-Monitoring Via Electronic Medication Monitor and Mobile App Plus Remote Clinician Feedback on Adherence to Inhaled Corticosteroids: A Randomized Controlled Trial.
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Mosnaim GS, Stempel DA, Gonzalez C, Adams B, BenIsrael-Olive N, Gondalia R, Kaye L, Shalowitz M, and Szefler S
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- Administration, Inhalation, Adrenal Cortex Hormones therapeutic use, Adult, Electronics, Feedback, Female, Humans, Male, Medication Adherence, Middle Aged, Anti-Asthmatic Agents therapeutic use, Mobile Applications
- Abstract
Background: Poor adherence to inhaled corticosteroids (ICSs) and overuse of short-acting beta
2 -agonists (SABAs) are associated with increased asthma morbidity., Objective: To assess whether patient self-monitoring via electronic medication monitoring and smartphone application plus remote clinician feedback influences ICS and SABA use., Methods: Adults with uncontrolled asthma and prescribed ICS and SABA were enrolled in this 14-week study. Inhalers were fitted with electronic medication monitoring to track real-time usage. After a 14-day baseline, participants were randomly assigned to the treatment group where they received reminders and feedback on ICS and SABA use via a smartphone application and clinician phone calls, or control group without feedback. Linear mixed models compared the baseline percentage of SABA-free days and ICS adherence to the last 14 study days., Results: Participants (n = 100) had a mean age of 48.5 years, 80% were female, 68% white, and 80% privately insured. The percentage of SABA-free days increased significantly in the treatment group (19%; 95% CI, 12 to 26; P < .01) and nonsignificantly in the control group (6%, 95% CI, -3 to 16; P = .18), representing a 13% (95% CI, 1-26; P = .04) difference. ICS adherence changed minimally in the treatment group (-2%; 95% CI, -7 to 3; P = .40), but decreased significantly (-17%; 95% CI, -26 to -8; P < .01) in the control group, representing a 15% (95% CI, 4 to 25; P < .01) difference., Conclusions: Patient self-monitoring via a digital platform plus remote clinician feedback maintained high baseline ICS adherence and decreased SABA use., (Copyright © 2020 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)- Published
- 2021
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27. Reply to "The forced renaissance of telemedicine during COVID-19: A fellow-in-training's perspective".
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Bansal P, Hare N, Bajowala SS, Abramson SL, Chervinskiy S, Corriel R, Hauswirth DW, Kakumanu S, Mehta R, Rashid Q, Rupp MR, Shih J, and Mosnaim GS
- Subjects
- Humans, SARS-CoV-2, COVID-19, Telemedicine
- Published
- 2021
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28. Work Group Report: COVID-19: Unmasking Telemedicine.
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Hare N, Bansal P, Bajowala SS, Abramson SL, Chervinskiy S, Corriel R, Hauswirth DW, Kakumanu S, Mehta R, Rashid Q, Rupp MR, Shih J, and Mosnaim GS
- Subjects
- Allergy and Immunology organization & administration, Betacoronavirus, COVID-19, Clinical Coding, Computer Security, Health Services Accessibility organization & administration, Humans, Hypersensitivity therapy, Infection Control organization & administration, Insurance, Health, Reimbursement, Pandemics, SARS-CoV-2, Societies, Medical, Telemedicine economics, Coronavirus Infections epidemiology, Pneumonia, Viral epidemiology, Telemedicine organization & administration
- Abstract
Telemedicine adoption has rapidly accelerated since the onset of the COVID-19 pandemic. Telemedicine provides increased access to medical care and helps to mitigate risk by conserving personal protective equipment and providing for social/physical distancing to continue to treat patients with a variety of allergic and immunologic conditions. During this time, many allergy and immunology clinicians have needed to adopt telemedicine expeditiously in their practices while studying the complex and variable issues surrounding its regulation and reimbursement. Some concerns have been temporarily alleviated since March 2020 to aid with patient care in the setting of COVID-19. Other changes are ongoing at the time of this publication. Members of the Telemedicine Work Group in the American Academy of Allergy, Asthma & Immunology (AAAAI) completed a telemedicine literature review of online and Pub Med resources through May 9, 2020, to detail Pre-COVID-19 telemedicine knowledge and outline up-to-date telemedicine material. This work group report was developed to provide guidance to allergy/immunology clinicians as they navigate the swiftly evolving telemedicine landscape., (Copyright © 2020 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)
- Published
- 2020
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29. The Adoption and Implementation of Digital Health Care in the Post-COVID-19 Era.
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Mosnaim GS, Stempel H, Van Sickle D, and Stempel DA
- Subjects
- Betacoronavirus, COVID-19, Computer Security, Confidentiality, Coronavirus Infections mortality, Electronic Health Records, Humans, Insurance, Health, Reimbursement, Monitoring, Ambulatory instrumentation, Pandemics, Pneumonia, Viral mortality, Remote Sensing Technology, SARS-CoV-2, Coronavirus Infections epidemiology, Monitoring, Ambulatory methods, Pneumonia, Viral epidemiology, Telemedicine organization & administration
- Published
- 2020
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30. Harmonized outcome measures for use in asthma patient registries and clinical practice.
- Author
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Gliklich RE, Castro M, Leavy MB, Press VG, Barochia A, Carroll CL, Harris J, Rittner SS, Freishtat R, Panettieri RA Jr, and Mosnaim GS
- Subjects
- Adult, Child, Humans, Patient Reported Outcome Measures, Asthma, Registries
- Abstract
Background: Asthma, a common chronic airway disorder, affects an estimated 25 million persons in the United States and 330 million persons worldwide. Although many asthma patient registries exist, the ability to link and compare data across registries is hindered by a lack of harmonization in the outcome measures collected by each registry., Objectives: The purpose of this project was to develop a minimum set of patient- and provider-relevant standardized outcome measures that could be collected in asthma patient registries and clinical practice., Methods: Asthma registries were identified through multiple sources and invited to join the workgroup and submit outcome measures. Additional measures were identified through literature searches and reviews of quality measures and consensus statements. Outcome measures were categorized by using the Agency for Healthcare Research and Quality's supported Outcome Measures Framework. A minimum set of broadly relevant measures was identified. Measure definitions were harmonized through in-person and virtual meetings., Results: Forty-six outcome measures, including those identified from 13 registries, were curated and harmonized into a minimum set of 21 measures in the Outcome Measures Framework categories of survival, clinical response, events of interest, patient-reported outcomes, resource utilization, and experience of care. The harmonized definitions build on existing consensus statements and are appropriate for adult and pediatric patients., Conclusions: The harmonized measures represent a minimum set of outcomes that are relevant in asthma research and clinical practice. Routine and consistent collection of these measures in registries and other systems would support creation of a national research infrastructure to efficiently address new questions and improve patient management and outcomes., (Copyright © 2019 American Academy of Allergy, Asthma & Immunology. All rights reserved.)
- Published
- 2019
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31. Family Chaos and Asthma Control.
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Weinstein SM, Pugach O, Rosales G, Mosnaim GS, Walton SM, and Martin MA
- Subjects
- Adolescent, Adult, Asthma diagnosis, Asthma epidemiology, Child, Child, Preschool, Cross-Sectional Studies, Depression diagnosis, Depression epidemiology, Female, Humans, Male, Stress Disorders, Post-Traumatic diagnosis, Stress Disorders, Post-Traumatic epidemiology, Asthma psychology, Depression psychology, Family Relations psychology, Stress Disorders, Post-Traumatic psychology
- Abstract
Objectives: Asthma is a highly prevalent childhood chronic disease, with particularly high rates among poor and minority youth. Psychosocial factors have been linked to asthma severity but remain poorly understood. This study examined (1) relationships between parent and child depression and posttraumatic stress disorder (PTSD) symptoms, family functioning, and child asthma control in a sample of urban minority youth with uncontrolled asthma and (2) family functioning as a pathway linking parent depression and asthma outcomes., Methods: Data were drawn from the baseline cohort of a randomized trial testing community interventions for children aged 5 to 16 with uncontrolled asthma ( N = 223; mean age = 9.37, SD = 3.02; 85.2% Hispanic). Asthma control was defined by using the Asthma Control Test and Childhood Asthma Control Test, activity limitation, and previous-12-month asthma severity. Psychosocial measures included parent and child depression and PTSD symptoms, family chaos, and parent social support., Results: Parent and child depression symptoms, but not PTSD, were associated with worse asthma control (β = -.20 [SE = 0.06] and β = -.12 [SE = -.03]; P < .001). Family chaos corresponded to worse asthma control, even when controlling for parent and child depression (β = -.33; [SE = 0.15]; P < .05), and was a mediator of the parent depression-asthma path. Emotional triggers of asthma also mediated the parent depression-asthma relationship., Conclusions: Findings highlight family chaos as a mechanism underlying the relationship between parent depression and child asthma control. Addressing parent and child depression, family routines, and predictability may optimize asthma outcomes., Competing Interests: POTENTIAL CONFLICT OF INTEREST: Dr Mosnaim receives research grant support from GlaxoSmithKline and Propeller Health, owns stock options in electroCore, and serves as a consultant and/or member of a scientific advisory board for electroCore, GlaxoSmithKline, Teva, Novartis, AstraZeneca, Boehringer Ingelheim, and Propeller Health; the other authors have indicated they have no potential conflicts of interest to disclose., (Copyright © 2019 by the American Academy of Pediatrics.)
- Published
- 2019
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32. Design and baseline characteristics of a low-income urban cohort of children with asthma: The Asthma Action at Erie Trial.
- Author
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Mosnaim GS, Weinstein SM, Pugach O, Rosales G, Roy A, Walton S, and Martin MA
- Subjects
- Adolescent, Child, Child, Preschool, Female, Humans, Male, Anti-Asthmatic Agents therapeutic use, Caregivers education, Chicago, House Calls, Research Design, Severity of Illness Index, Socioeconomic Factors, Randomized Controlled Trials as Topic, Urban Population, Asthma drug therapy, Asthma ethnology, Asthma physiopathology, Community Health Workers organization & administration, Hispanic or Latino education, Patient Education as Topic organization & administration, Poverty
- Abstract
Objective: To describe the methodology of a randomized controlled trial comparing the efficacy of integrated asthma community health workers (CHW) and a certified asthma educator (AE-C) to improve asthma outcomes in low-income minority children in Chicago., Methods: Child/caregiver dyads were randomized to CHW home visits or education in the clinic from an AE-C. Intervention was delivered in the first year after enrollment. Data collection occured at baseline, 6-, 12-, 18, and 24-months. The co-primary outcomes included asthma control using the Asthma Control Test/childhood Asthma Control Test (ACT/cACT) and activity limitation over the past 14 days., Results: A total of 223 participants ages 5-16 years were randomized. The majority of children were in the 5-11 year old range (78.9%). Most caregivers (96.9%) and 44% of children were female. Approximately 85% of caregivers and children reported Hispanic ethnicity and 62.3% reported a household income of ≤ $59,000. Over half (55.7%) had uncontrolled asthma as measured by ACT/cACT; 13.9% had a normal ACT/cACT score but were uncontrolled using the Asthma Control Questionnaire and 20.2% were controlled on both measures but had received oral steroids in the past year for asthma., Conclusion: The Asthma Action at Erie Trial successfully recruited a largely Hispanic cohort of children with uncontrolled or high-risk asthma to study the differential effects of clinic-based AE-C and home-based CHW interventions. Strengths of the trial include its comparative effectivness design that integrates interventionists and intervention delivery into a clinical setting. Categorizing asthma control in community settings for research purposes presents unique challenges., Clinical Trial Registration: University of Illinois at Chicago Protocol Record R01HL123797, Asthma Action at Erie TrialClinicalTrials.gov Identifier: NCT02481986 "ClinicalTrials.gov Registration" register@clinicaltrials.gov., (Copyright © 2019 Elsevier Inc. All rights reserved.)
- Published
- 2019
- Full Text
- View/download PDF
33. Behavioral interventions to improve asthma outcomes: a systematic review of recent publications.
- Author
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Mosnaim GS, Akkoyun E, Eng J, and Shalowitz MU
- Subjects
- Asthma psychology, Education, Distance, Family, Humans, Precision Medicine, Residence Characteristics, Self-Management, Volunteers, Asthma therapy, Behavior Therapy, Patient Education as Topic
- Abstract
Purpose of Review: Asthma outcomes are influenced by factors at multiple ecological levels: the individual and his/her family, home, medical care, and community. This systematic review describes recently published single-level and multilevel behavioral interventions to improve asthma outcomes., Recent Findings: Of the 23 total title/abstracts reviewed in the original systematic search of PubMed, Ovid, Scopus, PsychINFO, and CIHAHL reference review databases, six met inclusion criteria. Five of the studies focused on low-income and/or minority populations. Promising interventions include culturally tailored online asthma self-management programs and family-centered asthma education delivered at the bedside during hospitalization for an acute asthma exacerbation., Summary: Culturally, tailored online self-management programs offer difficult-to-reach populations asthma support that can be completed at the time and pace most convenient for the individual user. Family-focused asthma education, delivered at the bedside during an acute asthma hospitalization by highly motivated lay volunteers, is an efficacious and low-cost approach to improving pediatric asthma self-management.
- Published
- 2017
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34. Design of a pragmatic trial in minority children presenting to the emergency department with uncontrolled asthma: The CHICAGO Plan.
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Krishnan JA, Martin MA, Lohff C, Mosnaim GS, Margellos-Anast H, DeLisa JA, McMahon K, Erwin K, Zun LS, Berbaum ML, McDermott M, Bracken NE, Kumar R, Margaret Paik S, Nyenhuis SM, Ignoffo S, Press VG, Pittsenbarger ZE, and Thompson TM
- Subjects
- Anti-Asthmatic Agents therapeutic use, Asthma prevention & control, Chicago, Child, Child, Preschool, Female, Humans, Male, Patient Education as Topic, Quality Improvement, Self-Management, Black or African American statistics & numerical data, Asthma drug therapy, Emergency Service, Hospital statistics & numerical data
- Abstract
Among children with asthma, black children are two to four times as likely to have an emergency department (ED) visit and die from asthma, respectively, compared to white children in the United States. Despite the availability of evidence-based asthma management guidelines, minority children are less likely than white children to receive or use effective options for asthma care. The CHICAGO Plan is a three-arm multi-center randomized pragmatic trial of children 5 to 11years old presenting to the ED with uncontrolled asthma that compares: [1] an ED-focused intervention to improve the quality of care on discharge to home, [2] the same ED-focused intervention together with a home-based community health worker (CHW)-led intervention, and [3] enhanced usual care. All children receive spacers for the metered dose inhaler and teaching about its use. The Patient-Reported Outcomes Measurement Information System (PROMIS) Asthma Impact Scale and Satisfaction with Participation in Social Roles at 6months are the primary outcomes in children and in caregivers, respectively. Other patient-reported outcomes and indicators of healthcare utilization are assessed as secondary outcomes. Innovative features of the CHICAGO Plan include early and continuous engagement of children, caregivers, the Chicago Department of Public Health, and other stakeholders to inform the design and implementation of the study and a shared research infrastructure to coordinate study activities. The objective of this report is to describe the development of the CHICAGO Plan, including the methods and rationale for engaging stakeholders, the shared research infrastructure, and other features of the pragmatic clinical trial design., (Published by Elsevier Inc.)
- Published
- 2017
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35. Behavioral Interventions to Improve Asthma Outcomes for Adolescents: A Systematic Review.
- Author
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Mosnaim GS, Pappalardo AA, Resnick SE, Codispoti CD, Bandi S, Nackers L, Malik RN, Vijayaraghavan V, Lynch EB, and Powell LH
- Subjects
- Adolescent, Animals, Community Mental Health Services, Humans, Quality Improvement, Self Care, Treatment Outcome, Assertiveness, Asthma therapy, Behavior Therapy
- Abstract
Background: Factors at multiple ecological levels, including the child, family, home, medical care, and community, impact adolescent asthma outcomes., Objective: This systematic review characterizes behavioral interventions at the child, family, home, medical system, and community level to improve asthma management among adolescents., Methods: A systematic search of PubMed, SCOPUS, OVID, PsycINFO, CINAHL, and reference review databases was conducted from January 1, 2000, through August 10, 2014. Articles were included if the title or abstract included asthma AND intervention AND (education OR self-management OR behavioral OR technology OR trigger reduction), and the mean and/or median age of participants was between 11 and 16 years. We compared populations, intervention characteristics, study designs, outcomes, settings, and intervention levels across studies to evaluate behavioral interventions to improve asthma management for adolescents., Results: Of 1230 articles identified and reviewed, 24 articles (21 unique studies) met inclusion criteria. Promising approaches to improving adherence to daily controller medications include objective monitoring of inhaled corticosteroid adherence with allergist and/or immunologist feedback on medication-taking behavior and school nurse directly observed therapy. Efficacy at increasing asthma self-management skills was demonstrated using group interactive learning in the school setting. This systematic review is not a meta-analysis, thus limiting its quantitative assessment of studies. Publication bias may also limit our findings., Conclusions: Novel strategies to objectively increase controller medication adherence for adolescents include allergist and/or immunologist feedback and school nurse directly observed therapy. Schools, the most common setting across studies in this review, provide the opportunity for group interactive learning to improve asthma knowledge and self-management skills., (Copyright © 2015 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)
- Published
- 2016
- Full Text
- View/download PDF
36. Results from a community-based trial testing a community health worker asthma intervention in Puerto Rican youth in Chicago.
- Author
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Martin MA, Mosnaim GS, Olson D, Swider S, Karavolos K, and Rothschild S
- Subjects
- Adolescent, Chicago epidemiology, Child, Community-Based Participatory Research, Female, Humans, Male, Medication Adherence, Patient Education as Topic, Puerto Rico ethnology, Schools, Adrenal Cortex Hormones therapeutic use, Anti-Asthmatic Agents therapeutic use, Asthma drug therapy, Asthma ethnology, Community Health Workers, Hispanic or Latino
- Abstract
Unlabelled: Abstract Objective: Puerto Rican children suffer disproportionately from asthma. Project CURA tested the efficacy of a community health worker (CHW) intervention to improve use of inhaled corticosteroids (ICS) and reduce home asthma triggers in Puerto Rican youth in Chicago., Methods: This study employed a behavioral randomized controlled trial design with a community-based participatory research approach. Medications and technique were visually assessed; adherence was determined using dose counters. Home triggers were assessed via self-report, visual inspection and salivary cotinine. All participants received education on core asthma topics and self-management skills. Participants in the CHW arm were offered home education by the CHW in four visits over four months. The attention control arm received four newsletters covering the same topics., Results: While most of the participants had uncontrolled persistent asthma, <50% had ICS at baseline. In the CHW arms, 67% of participants received the full four-visit intervention. In the Elementary school cohort (n=51), the CHW arm had lower odds of having an ICS (OR=0.2; p=0.02) at 12-months; no differences were seen in other outcomes between arms at any time point. The only significant treatment arm difference in the high school cohort (n=50) was in inhaler technique where the CHW arm performed 18.0% more steps correct at five months (p<0.01) and 14.2% more steps correct at 12 months (p<0.01)., Conclusions: While this CHW intervention did not increase the number of participants with ICS or reduce home asthma triggers, important lessons were learned including challenges to CHW intervention fidelity and the need for CHWs to partner with clinical providers.
- Published
- 2015
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37. Feasibility of percutaneous vagus nerve stimulation for the treatment of acute asthma exacerbations.
- Author
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Miner JR, Lewis LM, Mosnaim GS, Varon J, Theodoro D, and Hoffmann TJ
- Subjects
- Acute Disease, Adult, Aged, Feasibility Studies, Female, Forced Expiratory Volume, Humans, Male, Middle Aged, Prospective Studies, Spirometry, Treatment Outcome, Vital Signs, Work of Breathing, Asthma therapy, Emergency Service, Hospital, Vagus Nerve Stimulation methods
- Abstract
Objectives: This study assessed the feasibility of an investigational vagus nerve stimulation (VNS) device for treating acute asthma exacerbations in patients not responding to at least 1 hour of initial standard care therapy., Methods: This was a prospective, nonrandomized study of patients treated in the ED for moderate to severe acute asthma (forced expiratory volume in 1 second [FEV(1)] 25% to 70% of predicted). Treatment entailed percutaneous placement of an electrode near the right carotid sheath and 60 minutes of VNS and continued standard care. VNS voltage was adjusted to perceived improvement, muscle twitching, or adverse events (AEs). All AEs, vital signs, FEV(1), perceived work of breathing (WOB), and final disposition were recorded., Results: Twenty-five subjects were enrolled. There were no serious AEs and no significant changes in vital signs. No subject required terminating VNS. One patient had minor bleeding from the procedure, and one had a hematoma and withdrew prior to VNS. AEs related to VNS were temporary and included cough (1 of 24), swallowing difficulty (2 of 24), voice change (2 of 24), and muscle twitching (14 of 24). These resolved when VNS ended. The FEV(1) improved at 15 minutes (median = 15.8%, 95% confidence interval [CI] = 9.3% to 22.4%), 30 minutes (median = 21.3%, 95% CI = 8.1% to 36.5%), and 60 minutes (median = 27.5%, 95% CI = 11.3% to 43.5%). WOB improved at 15 minutes (median = 53.9%, 95% CI = 33.7% to 73.9%), 30 minutes (median = 69.1%, 95% CI = 56.4% to 81.8%), and 60 minutes (median = 81.0%, 95% CI = 68.5% to 93.5%)., Conclusions: Percutaneous VNS did not result in serious AEs and was associated with improvements in FEV(1) and perceived dyspnea. Percutaneous VNS appears to be feasible for use in the treatment of moderate to severe acute asthma in patients unresponsive to initial standard care treatment., (© 2012 by the Society for Academic Emergency Medicine.)
- Published
- 2012
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38. Evaluation of an asthma medication training program for immigrant Mexican community health workers.
- Author
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Martin MA, Mosnaim GS, Rojas D, Hernandez O, and Sadowski LS
- Subjects
- Adult, Emigrants and Immigrants education, Female, Humans, Middle Aged, Program Evaluation, Self Care methods, Asthma drug therapy, Community Health Workers education, Medication Adherence, Mexican Americans education
- Abstract
Background: Community health workers (CHWs) are frontline public health workers who connect immigrant communities with health care services. Although CHW asthma interventions have been shown to improve some outcomes, their ability to change medication adherence remains unclear., Objective: Our goal was to determine if intensive asthma medication training resulted in objective improvements in asthma medication instruction abilities for immigrant Mexican CHWs., Methods: Eleven CHWs participated in a 15-hour training course conducted in only Spanish. The course covered asthma pathophysiology, reliever and controller medications, medication technique, and self-management skills. Before and after the training, CHWs completed a written asthma knowledge test and were tested on medication delivery technique using a demonstrator metered dose inhaler (MDI), spacer, and dry powder inhaler (DPI). After the training, CHWs performed a standardized role play to assess their ability to deliver medication instruction. At follow-up evaluations, the CHWs described benefits and weaknesses of the training., Results: Before the training, the median correct medication technique scores were: MDI = 25%, spacer = 0%, and DPI = 0%. After the training, the median scores were: MDI = 69%, spacer = 64%, and DPI = 67% (p < .01). On the role plays, all CHWs were scored as "Demonstrates adequate understanding of a complicated skill" and four were "Ready for the field on a clinical trial." The CHWs described specific application of training skills during the subsequent delivery of an asthma intervention., Conclusion: This training and follow-up evaluation provide objective evidence of improved asthma medication knowledge, delivery technique, and instruction abilities in immigrant Mexican CHWs. With proper training, CHWs can assist families to understand and correctly use complicated asthma medications.
- Published
- 2011
- Full Text
- View/download PDF
39. Adding montelukast to fluticasone propionate/salmeterol for control of asthma and seasonal allergic rhinitis.
- Author
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Katial RK, Oppenheimer JJ, Ostrom NK, Mosnaim GS, Yancey SW, Waitkus-Edwards KR, Prillaman BA, and Ortega HG
- Subjects
- Administration, Inhalation, Administration, Intranasal, Adult, Albuterol administration & dosage, Albuterol therapeutic use, Asthma physiopathology, Cyclopropanes, Drug Combinations, Drug Therapy, Combination, Female, Fluticasone-Salmeterol Drug Combination, Humans, Male, Middle Aged, Rhinitis, Allergic, Seasonal physiopathology, Sulfides, Treatment Outcome, Young Adult, Acetates administration & dosage, Acetates therapeutic use, Albuterol analogs & derivatives, Androstadienes administration & dosage, Androstadienes therapeutic use, Anti-Allergic Agents administration & dosage, Anti-Allergic Agents therapeutic use, Anti-Asthmatic Agents administration & dosage, Anti-Asthmatic Agents therapeutic use, Asthma drug therapy, Quinolines administration & dosage, Quinolines therapeutic use, Rhinitis, Allergic, Seasonal drug therapy
- Abstract
Limited information exists comparing fluticasone propionate/salmeterol combination (FSC) versus montelukast (MON) in patients with coexistent asthma and allergic rhinitis. The purpose of this study was to compare the addition of MON to patients receiving FSC on asthma control while experiencing asthma and allergy symptoms. Additionally, the effect of fluticasone propionate aqueous nasal spray (FPANS) and MON were assessed in allergic rhinitis control. Symptomatic patients (n = 1385) with asthma and seasonal allergic rhinitis were randomized to receive FSC, 100/50 micrograms twice daily; FSC twice daily + FPANS, 200 micrograms once daily; FSC twice daily + MON, 10 mg once daily; or MON once daily for 4 weeks during the allergy pollen season. Patients recorded peak expiratory flow, rescue albuterol use, and asthma and rhinitis symptoms. No additional improvements in overall asthma control were seen when MON was added to FSC. Treatment with FSC produced significant (p < 0.001) improvements in all clinical and patient-reported measures versus MON. FSC + FPANS was superior to FSC + MON (p < or = 0.001) in improving daytime and nighttime total nasal symptom scores. Adverse events were similar. In patients with asthma and allergic rhinitis, adding MON to FSC provided no additional benefit in asthma control. FSC resulted in superior improvement in asthma control compared with MON. FPANS also provided superior nasal symptom control versus MON in allergic patients treated with FSC for asthma. Optimal disease control in patients with asthma and allergic rhinitis should be achieved by the most effective therapy directed toward each disease component.
- Published
- 2010
- Full Text
- View/download PDF
40. Use of MP3 players to increase asthma knowledge in inner-city African-American adolescents.
- Author
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Mosnaim GS, Cohen MS, Rhoads CH, Rittner SS, and Powell LH
- Subjects
- Adolescent, Black or African American psychology, Asthma psychology, Child, Double-Blind Method, Female, Humans, Male, Music, Patient Compliance psychology, Pilot Projects, Black or African American education, Asthma rehabilitation, Health Knowledge, Attitudes, Practice, MP3-Player, Patient Education as Topic methods, Urban Population
- Abstract
Background: Low-income African-American adolescents suffer a disproportionate burden of asthma morbidity., Purpose: To evaluate the ability of our intervention, the Adolescents' Disease Empowerment and Persistency Technology (ADEPT) for asthma, to increase asthma knowledge in our target population., Methods: This was a 14-week (2-week run-in and 12-week treatment) randomized, double-blind, placebo-controlled pilot study in which 28 inner-city African-American adolescents with asthma, between 10 and 18 years of age, were randomized to receive (1) celebrity asthma messages (experimental group), or (2) general health messages (control group) between music tracks on an MP3 player. The asthma messages were recorded by famous athletes, musicians, and other celebrities popular among this group of teenagers. Asthma knowledge, assessed by the ZAP Asthma Knowledge instrament, was collected pre- and post-intervention., Results: Mean improvement in ZAP score was significantly higher in the experimental group (8.1%, SD 7.2%) than the control group (0.4%, SD 7.2%) (p = 0.05)., Conclusion: These findings suggest that this may be an innovative and promising new approach to improving asthma outcomes in this difficult-to-reach population.
- Published
- 2008
- Full Text
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41. Parental language and asthma among urban Hispanic children.
- Author
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Mosnaim GS, Sadowski LS, Durazo-Arvizu RA, Sharp LK, Curtis LM, Shalowitz MU, Shannon JJ, and Weiss KB
- Subjects
- Chicago ethnology, Child, Female, Humans, Male, Parents, Urban Population, Asthma diagnosis, Asthma ethnology, Communication Barriers, Hispanic or Latino, Language
- Abstract
Background: Many Hispanics in the United States have limited English proficiency and prefer communicating in Spanish. Language barriers are known to adversely affect health care quality and outcomes., Objective: We explored the relationship between parent language preference in a Hispanic population and the likelihood that a child with symptoms receives a diagnosis of asthma., Methods: We conducted a school-based survey in 105 Chicago public and Catholic schools. Our sample included 14,177 Hispanic children 6 to 12 years of age with a parent who completed an asthma survey. Outcomes of diagnosed asthma and possible asthma (asthma symptoms without diagnosis) were assessed by using the Brief Pediatric Asthma Screen Plus instrument., Results: Overall, 12.0% of children had diagnosed asthma, and 12.7% had possible asthma. Parents of children at risk who completed the survey in English reported higher rates of asthma diagnosis compared with parents who completed it in Spanish (55.2% vs 36.3%, P < .001). Predictors of asthma diagnosis were child sex, parental language preference, parental asthma status, and other household members with asthma., Conclusions: Parental language preference might be an important characteristic associated with childhood asthma diagnosis. Whether language itself is the key factor or the fact that language is a surrogate for other attributes of acculturation needs to be explored., Clinical Implications: Our findings suggest that estimates of asthma among Hispanic schoolchildren might be low because of underdiagnosis among children whose parents prefer communicating in Spanish.
- Published
- 2007
- Full Text
- View/download PDF
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