المؤلفون: Friedly, Janna, Bauer, Zoya, Penson, David, Stillman, Arthur, Vollmer, William, Warren, Stephen, Zhan, Chunliu, Hsia, David, Trontell, Anne, Smith-Bindman, Rebecca, Comstock, Bryan, DiMango, Emily, Ferrara, Assiamira, Huang, Susan, Israel, Elliot, Jarvik, Jeffrey, Nierenberg, Andrew, Ong, Michael

مصطلحات موضوعية: Biomedical and Clinical Sciences, Clinical Sciences, Health Sciences, Comparative Effectiveness Research, Clinical Trials and Supportive Activities, Clinical Research, Health Services, Patient Safety, Good Health and Well Being

الوصول الحر: https://escholarship.org/uc/item/36c4581gTest

المؤلفون: Georas, Steve N, Wright, Rosalind J, Ivanova, Anastasia, Israel, Elliot, LaVange, Lisa M, Akuthota, Praveen, Carr, Tara F, Denlinger, Loren C, Fajt, Merritt L, Kumar, Rajesh, O’Neal, Wanda K, Phipatanakul, Wanda, Szefler, Stanley J, Aronica, Mark A, Bacharier, Leonard B, Burbank, Allison J, Castro, Mario, Alexander, Laura Crotty, Bamdad, Julie, Cardet, Juan Carlos, Comhair, Suzy AA, Covar, Ronina A, DiMango, Emily A, Erwin, Kim, Erzurum, Serpil C, Fahy, John V, Gaffin, Jonathan M, Gaston, Benjamin, Gerald, Lynn B, Hoffman, Eric A, Holguin, Fernando, Jackson, Daniel J, James, John, Jarjour, Nizar N, Kenyon, Nicholas J, Khatri, Sumita, Kirwan, John P, Kraft, Monica, Krishnan, Jerry A, Liu, Andrew H, Liu, Mark C, Marquis, M Alison, Martinez, Fernando, Mey, Jacob, Moore, Wendy C, Moy, James N, Ortega, Victor E, Peden, David B, Pennington, Emily, Peters, Michael C, Ross, Kristie, Sanchez, Maria, Smith, Lewis J, Sorkness, Ronald L, Wechsler, Michael E, Wenzel, Sally E, White, Steven R, Zein, Joe, Zeki, Amir A, Noel, Patricia, Billheimer, Dean, Bleecker, Eugene R, Branch, Emily, Conway, Michelle, Daines, Cori, Deaton, Isaac, Evans, Alexandria, Field, Paige, Francisco, Dave, Hastie, Annette T, Hmieleski, Bob, Krings, Jeffrey O, Liu, Yanqin, Merchen, Janell L, Meyers, Deborah A, Narendran, Nirushan, Peters, Stephen P, Pippins, Anna, Rank, Matthew A, Schunk, Ronald, Skeps, Raymond, Wright, Benjamin, Banzon, Tina M, Bartnikas, Lisa M, Baxi, Sachin N, Betapudi, Vishwanath, Brick, Isabelle, Brockway, Conor, Casale, Thomas B, Castillo-Ruano, Kathleen, Cinelli, Maria Angeles, Crestani, Elena, Cunningham, Amparito, Day-Lewis, Megan, Diaz-Cabrera, Natalie, DiMango, Angela, Esty, Brittany, Fandozzi, Eva, Fernandez, Jesse, Fitzpatrick, Elizabeth

المصدر: Journal of Allergy and Clinical Immunology. 149(2)

مصطلحات موضوعية: Biomedical and Clinical Sciences, Clinical Sciences, Lung, Clinical Research, Clinical Trials and Supportive Activities, Asthma, Respiratory, Good Health and Well Being, Advisory Committees, Biomarkers, Clinical Protocols, Clinical Trials, Phase II as Topic, Humans, Precision Medicine, Research Design, Severity of Illness Index, Tomography, X-Ray Computed, Severe asthma, precision medicine, adaptive clinical trial design, asthma exacerbation, type 2 asthma, non-type 2 asthma, patient advisory committee, biomarker, PrecISE Study Team, non–type 2 asthma, Immunology, Allergy

الوصف: Asthma is a heterogeneous disease, with multiple underlying inflammatory pathways and structural airway abnormalities that impact disease persistence and severity. Recent progress has been made in developing targeted asthma therapeutics, especially for subjects with eosinophilic asthma. However, there is an unmet need for new approaches to treat patients with severe and exacerbation-prone asthma, who contribute disproportionately to disease burden. Extensive deep phenotyping has revealed the heterogeneous nature of severe asthma and identified distinct disease subtypes. A current challenge in the field is to translate new and emerging knowledge about different pathobiologic mechanisms in asthma into patient-specific therapies, with the ultimate goal of modifying the natural history of disease. Here, we describe the Precision Interventions for Severe and/or Exacerbation-Prone Asthma (PrecISE) Network, a groundbreaking collaborative effort of asthma researchers and biostatisticians from around the United States. The PrecISE Network was designed to conduct phase II/proof-of-concept clinical trials of precision interventions in the population with severe asthma, and is supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health. Using an innovative adaptive platform trial design, the PrecISE Network will evaluate up to 6 interventions simultaneously in biomarker-defined subgroups of subjects. We review the development and organizational structure of the PrecISE Network, and choice of interventions being studied. We hope that the PrecISE Network will enhance our understanding of asthma subtypes and accelerate the development of therapeutics for severe asthma.

وصف الملف: application/pdf

الوصول الحر: https://escholarship.org/uc/item/4n8620m5Test

المؤلفون: Beswick, Daniel M., Liu, Christine M., Overdevest, Jonathan B., Zemke, Anna, Khatiwada, Aastha, Gudis, David A., Miller, Jessa E., Kimple, Adam, Tervo, Jeremy P., DiMango, Emily, Goralski, Jennifer L., Keating, Claire, Senior, Brent, Stapleton, Amanda L., Eshaghian, Patricia H., Mace, Jess C., Markarian, Karolin, Alt, Jeremiah A., Bodner, Todd E., Chowdhury, Naweed I., Getz, Anne E., Hwang, Peter H., Khanwalker, Ashoke, Lee, Jivianne T., Li, Douglas A., Norris, Meghan, Nayak, Jayakar V., Owens, Cameran, Patel, Zara M., Poch, Katie, Schlosser, Rodney J., Smith, Kristine A., Smith, Timothy L., Soler, Zachary M., Suh, Jeffrey D., Turner, Grant A., Wang, Marilene B., Saavedra, Milene T., Taylor Cousar, Jennifer L.

المساهمون: Cystic Fibrosis Foundation, National Institute on Deafness and Other Communication Disorders

المصدر: The Laryngoscope ; ISSN 0023-852X 1531-4995

الوصف: Objectives The 22‐question SinoNasal Outcome Test (SNOT‐22) assesses chronic rhinosinusitis (CRS) severity. We aimed to identify predictors of SNOT‐22 score improvement following highly effective modulator therapy (HEMT) initiation and to corroborate the SNOT‐22 minimal clinically important difference (MCID) in adults with cystic fibrosis (CF). Methods Prospective observational data was pooled from four studies across 10 US centers investigating people with CF (PwCF) and CRS. Three studies evaluated HEMT's impact on CRS. For participants enrolled prior to HEMT initiation, SNOT‐22 scores were obtained at baseline and after 3–6 months of HEMT. Multivariate regression identified predictors of improvement. Cronbach's alpha and four distribution‐based methods were used to assess internal consistency and calculate the MCID of the SNOT‐22. Results A total of 184 PwCF participated with mean baseline SNOT‐22 scores ranging from 18.1 to 56.7. Cronbach's alpha was ≥0.90 across sites. Participants at sites with pre‐ and post‐HEMT data reported improvement in SNOT‐22 scores after initiating HEMT (all p < 0.05). Worse baseline SNOT‐22 score (odds ratio (OR): 1.05, p < 0.001, 95% CI: 1.02–1.08), F508del homozygosity (OR: 4.30, p = 0.040, 95% CI: 1.14–18.99), and absence of prior modulator therapy (OR: 4.99, p = 0.017, 95% CI: 1.39–20.11) were associated with greater SNOT‐22 improvement. The mean MCID calculated via distribution‐based methods was 8.5. Conclusion Worse baseline sinonasal symptoms, F508del homozygosity, and absence of prior modulator therapy predicted greater improvement after HEMT initiation. The mean MCID for SNOT‐22 in PwCF is 8.5 points, similar to non‐CF individuals with CRS, and provides a threshold specifically for PwCF. The SNOT‐22 has strong internal consistency in PwCF. Level of Evidence 3 Laryngoscope , 2024

الإتاحة: https://doi.org/10.1002/lary.31438Test

المؤلفون: Ortega, Victor E, Daya, Michelle, Szefler, Stanley J, Bleecker, Eugene R, Chinchilli, Vernon M, Phipatanakul, Wanda, Mauger, Dave, Martinez, Fernando D, Herrera-Luis, Esther, Pino-Yanes, Maria, Hawkins, Gregory A, Ampleford, Elizabeth J, Kunselman, Susan J, Cox, Corey, Bacharier, Leonard B, Cabana, Michael D, Cardet, Juan Carlos, Castro, Mario, Denlinger, Loren C, Eng, Celeste, Fitzpatrick, Anne M, Holguin, Fernando, Hu, Donglei, Jackson, Daniel J, Jarjour, Nizar, Kraft, Monica, Krishnan, Jerry A, Lazarus, Stephen C, Lemanske, Robert F, Lima, John J, Lugogo, Njira, Mak, Angel, Moore, Wendy C, Naureckas, Edward T, Peters, Stephen P, Pongracic, Jacqueline A, Sajuthi, Satria P, Seibold, Max A, Smith, Lewis J, Solway, Julian, Sorkness, Christine A, Wenzel, Sally, White, Steven R, Burchard, Esteban G, Barnes, Kathleen, Meyers, Deborah A, Israel, Elliot, Wechsler, Michael E, AsthmaNet, NHLBI, Ali-Dinar, Tarig, Bartnikas, Lisa, Baxi, Sachin, Beigelman, Avraham, Benson, Mindy, Blake, Kathryn V, Burke-Roberts, Elizabeth, Cernadas, Manuela, Chmiel, James F, Covar, Ronina, DiMango, Emily, Gaffin, Jonathan, Gentile, Deborah, Grossman, Nicole, Hautpman, Marissa, Kantor, David, Kumar, Harsha, LaForce, Craig F, Lang, Jason, Long, Dayna, Louisias, Margee, Morgan, Wayne, Moy, James, Myers, Ross E, Olin, J Tod, Permaul, Perdita, Que, Loretta, Raissy, Hengameh, Robison, Rachel G, Ross, Kristie, Sheehan, William, Sullivan-Vedder, Lisa, Wright, Lakeia

المصدر: The Lancet Child & Adolescent Health. 5(12)

مصطلحات موضوعية: Human Genome, Pediatric, Genetics, Lung, Clinical Research, Clinical Trials and Supportive Activities, Asthma, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Respiratory, Administration, Inhalation, Adolescent, Adrenal Cortex Hormones, Adult, Black People, Bronchodilator Agents, Child, Drug Therapy, Combination, Female, Fluticasone, Humans, Male, Middle Aged, Pharmacogenomic Testing, Salmeterol Xinafoate, United States, Young Adult, NHLBI AsthmaNet

الوصف: BackgroundPharmacogenetic studies in asthma cohorts, primarily made up of White people of European descent, have identified loci associated with response to inhaled beta agonists and corticosteroids (ICSs). Differences exist in how individuals from different ancestral backgrounds respond to long-acting beta agonist (LABA) and ICSs. Therefore, we sought to understand the pharmacogenetic mechanisms regulating therapeutic responsiveness in individuals of African descent.MethodsWe did ancestry-based pharmacogenetic studies of children (aged 5-11 years) and adolescents and adults (aged 12-69 years) from the Best African Response to Drug (BARD) trials, in which participants with asthma uncontrolled with low-dose ICS (fluticasone propionate 50 μg in children, 100 μg in adolescents and adults) received different step-up combination therapies. The hierarchal composite outcome of pairwise superior responsiveness in BARD was based on asthma exacerbations, a 31-day difference in annualised asthma-control days, or a 5% difference in percentage predicted FEV1. We did whole-genome admixture mapping of 15 159 ancestral segments within 312 independent regions, stratified by the two age groups. The two co-primary outcome comparisons were the step up from low-dose ICS to the quintuple dose of ICS (5 × ICS: 250 μg twice daily in children and 500 μg twice daily in adolescents and adults) versus double dose (2-2·5 × ICS: 100 μg twice daily in children, 250 μg twice daily in adolescents and adults), and 5 × ICS versus 100 μg fluticasone plus a LABA (salmeterol 50 μg twice daily). We used a genome-wide significance threshold of p

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الوصول الحر: https://escholarship.org/uc/item/2x5116nmTest

المؤلفون: Israel, Elliot, Denlinger, Loren C, Bacharier, Leonard B, LaVange, Lisa M, Moore, Wendy C, Peters, Michael C, Georas, Steve N, Wright, Rosalind J, Mauger, David T, Noel, Patricia, Akuthota, Praveen, Bach, Julia, Bleecker, Eugene R, Cardet, Juan Carlos, Carr, Tara F, Castro, Mario, Cinelli, Angeles, Comhair, Suzy AA, Covar, Ronina A, Alexander, Laura Crotty, DiMango, Emily A, Erzurum, Serpil C, Fahy, John V, Fajt, Merritt L, Gaston, Benjamin M, Hoffman, Eric A, Holguin, Fernando, Jackson, Daniel J, Jain, Sonia, Jarjour, Nizar N, Ji, Yuan, Kenyon, Nicholas J, Kosorok, Michael R, Kraft, Monica, Krishnan, Jerry A, Kumar, Rajesh, Liu, Andrew H, Liu, Mark C, Ly, Ngoc P, Marquis, M Alison, Martinez, Fernando D, Moy, James N, O'Neal, Wanda K, Ortega, Victor E, Peden, David B, Phipatanakul, Wanda, Ross, Kristie, Smith, Lewis J, Szefler, Stanley J, Teague, W Gerald, Tulchinsky, Abigail F, Vijayanand, Pandurangan, Wechsler, Michael E, Wenzel, Sally E, White, Steven R, Zeki, Amir A, Ivanova, Anastasia

المصدر: Journal of Allergy and Clinical Immunology. 147(5)

مصطلحات موضوعية: Biomedical and Clinical Sciences, Immunology, Clinical Research, Biotechnology, Lung, Clinical Trials and Supportive Activities, Asthma, Respiratory, Good Health and Well Being, Biomarkers, Humans, Precision Medicine, Randomized Controlled Trials as Topic, Research Design, Severe asthma, therapy, clinical trial, biomarkers, precision medicine, adaptive design, master protocol, platform trial, Allergy

الوصف: Severe asthma accounts for almost half the cost associated with asthma. Severe asthma is driven by heterogeneous molecular mechanisms. Conventional clinical trial design often lacks the power and efficiency to target subgroups with specific pathobiological mechanisms. Furthermore, the validation and approval of new asthma therapies is a lengthy process. A large proportion of that time is taken by clinical trials to validate asthma interventions. The National Institutes of Health Precision Medicine in Severe and/or Exacerbation Prone Asthma (PrecISE) program was established with the goal of designing and executing a trial that uses adaptive design techniques to rapidly evaluate novel interventions in biomarker-defined subgroups of severe asthma, while seeking to refine these biomarker subgroups, and to identify early markers of response to therapy. The novel trial design is an adaptive platform trial conducted under a single master protocol that incorporates precision medicine components. Furthermore, it includes innovative applications of futility analysis, cross-over design with use of shared placebo groups, and early futility analysis to permit more rapid identification of effective interventions. The development and rationale behind the study design are described. The interventions chosen for the initial investigation and the criteria used to identify these interventions are enumerated. The biomarker-based adaptive design and analytic scheme are detailed as well as special considerations involved in the final trial design.

وصف الملف: application/pdf

الوصول الحر: https://escholarship.org/uc/item/73f1w5tqTest

المؤلفون: Ivanova, Anastasia, Israel, Elliot, LaVange, Lisa M, Peters, Michael C, Denlinger, Loren C, Moore, Wendy C, Bacharier, Leonard B, Marquis, M Alison, Gotman, Nathan M, Kosorok, Michael R, Tomlinson, Chalmer, Mauger, David T, Georas, Steve N, Wright, Rosalind J, Noel, Patricia, Rosner, Gary L, Akuthota, Praveen, Billheimer, Dean, Bleecker, Eugene R, Cardet, Juan Carlos, Castro, Mario, DiMango, Emily A, Erzurum, Serpil C, Fahy, John V, Fajt, Merritt L, Gaston, Benjamin M, Holguin, Fernando, Jain, Sonia, Kenyon, Nicholas J, Krishnan, Jerry A, Kraft, Monica, Kumar, Rajesh, Liu, Mark C, Ly, Ngoc P, Moy, James N, Phipatanakul, Wanda, Ross, Kristie, Smith, Lewis J, Szefler, Stanley J, Teague, W Gerald, Wechsler, Michael E, Wenzel, Sally E, White, Steven R

المصدر: Journal of Biopharmaceutical Statistics. 30(6)

مصطلحات موضوعية: Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Lung, Clinical Trials and Supportive Activities, Biotechnology, Asthma, Respiratory, Good Health and Well Being, Biomarkers, Humans, Research Design, Master protocol, platform trial, covariate adaptive randomization, adaptive enrichment, compex, severe asthma, Pharmacology and Pharmaceutical Sciences, Statistics & Probability, Pharmacology and pharmaceutical sciences, Statistics

الوصف: The Precision Interventions for Severe and/or Exacerbation-prone Asthma (PrecISE) study is an adaptive platform trial designed to investigate novel interventions to severe asthma. The study is conducted under a master protocol and utilizes a crossover design with each participant receiving up to five interventions and at least one placebo. Treatment assignments are based on the patients' biomarker profiles and precision health methods are incorporated into the interim and final analyses. We describe key elements of the PrecISE study including the multistage adaptive enrichment strategy, early stopping of an intervention for futility, power calculations, and the primary analysis strategy.

وصف الملف: application/pdf

الوصول الحر: https://escholarship.org/uc/item/3ph8t3tmTest

المؤلفون: Wechsler, Michael E, Szefler, Stanley J, Ortega, Victor E, Pongracic, Jacqueline A, Chinchilli, Vernon, Lima, John J, Krishnan, Jerry A, Kunselman, Susan J, Mauger, David, Bleecker, Eugene R, Bacharier, Leonard B, Beigelman, Avraham, Benson, Mindy, Blake, Kathryn V, Cabana, Michael D, Cardet, Juan-Carlos, Castro, Mario, Chmiel, James F, Covar, Ronina, Denlinger, Loren, DiMango, Emily, Fitzpatrick, Anne M, Gentile, Deborah, Grossman, Nicole, Holguin, Fernando, Jackson, Daniel J, Kumar, Harsha, Kraft, Monica, LaForce, Craig F, Lang, Jason, Lazarus, Stephen C, Lemanske, Robert F, Long, Dayna, Lugogo, Njira, Martinez, Fernando, Meyers, Deborah A, Moore, Wendy C, Moy, James, Naureckas, Edward, Olin, J Tod, Peters, Stephen P, Phipatanakul, Wanda, Que, Loretta, Raissy, Hengameh, Robison, Rachel G, Ross, Kristie, Sheehan, William, Smith, Lewis J, Solway, Julian, Sorkness, Christine A, Sullivan-Vedder, Lisa, Wenzel, Sally, White, Steven, Israel, Elliot

المصدر: New England Journal of Medicine. 381(13)

مصطلحات موضوعية: Biomedical and Clinical Sciences, Clinical Sciences, Pediatric, Clinical Research, Lung, Asthma, Clinical Trials and Supportive Activities, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Respiratory, Administration, Inhalation, Adolescent, Adrenergic beta-2 Receptor Agonists, Adult, Black or African American, Bronchodilator Agents, Child, Child, Preschool, Cross-Over Studies, Dose-Response Relationship, Drug, Double-Blind Method, Drug Combinations, Female, Fluticasone, Glucocorticoids, Humans, Male, Prospective Studies, Salmeterol Xinafoate, NHLBI AsthmaNet, Medical and Health Sciences, General & Internal Medicine, Biomedical and clinical sciences, Health sciences

الوصف: BackgroundMorbidity from asthma is disproportionately higher among black patients than among white patients, and black patients constitute the minority of participants in trials informing treatment. Data indicate that patients with inadequately controlled asthma benefit more from addition of a long-acting beta-agonist (LABA) than from increased glucocorticoids; however, these data may not be informative for treatment in black patients.MethodsWe conducted two prospective, randomized, double-blind trials: one involving children and the other involving adolescents and adults. In both trials, the patients had at least one grandparent who identified as black and had asthma that was inadequately controlled with low-dose inhaled glucocorticoids. We compared combinations of therapy, which included the addition of a LABA (salmeterol) to an inhaled glucocorticoid (fluticasone propionate), a step-up to double to quintuple the dose of fluticasone, or both. The treatments were compared with the use of a composite measure that evaluated asthma exacerbations, asthma-control days, and lung function; data were stratified according to genotypic African ancestry.ResultsWhen quintupling the dose of fluticasone (to 250 μg twice a day) was compared with adding salmeterol (50 μg twice a day) and doubling the fluticasone (to 100 μg twice a day), a superior response occurred in 46% of the children with quintupling the fluticasone and in 46% of the children with doubling the fluticasone and adding salmeterol (P = 0.99). In contrast, more adolescents and adults had a superior response to added salmeterol than to an increase in fluticasone (salmeterol-low-dose fluticasone vs. medium-dose fluticasone, 49% vs. 28% [P = 0.003]; salmeterol-medium-dose fluticasone vs. high-dose fluticasone, 49% vs. 31% [P = 0.02]). Neither the degree of African ancestry nor baseline biomarkers predicted a superior response to specific treatments. The increased dose of inhaled glucocorticoids was associated with a decrease in the ratio of urinary cortisol to creatinine in children younger than 8 years of age.ConclusionsIn contrast to black adolescents and adults, almost half the black children with poorly controlled asthma had a superior response to an increase in the dose of an inhaled glucocorticoid and almost half had a superior response to the addition of a LABA. (Funded by the National Heart, Lung, and Blood Institute; BARD ClinicalTrials.gov number, NCT01967173.).

وصف الملف: application/pdf

الوصول الحر: https://escholarship.org/uc/item/2058s93qTest

المؤلفون: Lazarus, Stephen C, Krishnan, Jerry A, King, Tonya S, Lang, Jason E, Blake, Kathryn V, Covar, Ronina, Lugogo, Njira, Wenzel, Sally, Chinchilli, Vernon M, Mauger, David T, Dyer, Anne-Marie, Boushey, Homer A, Fahy, John V, Woodruff, Prescott G, Bacharier, Leonard B, Cabana, Michael D, Cardet, Juan C, Castro, Mario, Chmiel, James, Denlinger, Loren, DiMango, Emily, Fitzpatrick, Anne M, Gentile, Deborah, Hastie, Annette, Holguin, Fernando, Israel, Elliot, Jackson, Daniel, Kraft, Monica, LaForce, Craig, Lemanske, Robert F, Martinez, Fernando D, Moore, Wendy, Morgan, Wayne J, Moy, James N, Myers, Ross, Peters, Stephen P, Phipatanakul, Wanda, Pongracic, Jacqueline A, Que, Loretta, Ross, Kristie, Smith, Lewis, Szefler, Stanley J, Wechsler, Michael E, Sorkness, Christine A

المصدر: New England Journal of Medicine. 380(21)

مصطلحات موضوعية: Lung, Clinical Research, Clinical Trials and Supportive Activities, Asthma, 6.1 Pharmaceuticals, 4.2 Evaluation of markers and technologies, Detection, screening and diagnosis, Evaluation of treatments and therapeutic interventions, Respiratory, Administration, Inhalation, Adolescent, Adult, Bronchodilator Agents, Cross-Over Studies, Double-Blind Method, Eosinophils, Female, Glucocorticoids, Humans, Leukocyte Count, Male, Medication Adherence, Middle Aged, Mometasone Furoate, Sputum, Tiotropium Bromide, Young Adult, National Heart, Lung, and Blood Institute AsthmaNet, Medical and Health Sciences, General & Internal Medicine

الوصف: BACKGROUND:In many patients with mild, persistent asthma, the percentage of eosinophils in sputum is less than 2% (low eosinophil level). The appropriate treatment for these patients is unknown. METHODS:In this 42-week, double-blind, crossover trial, we assigned 295 patients who were at least 12 years of age and who had mild, persistent asthma to receive mometasone (an inhaled glucocorticoid), tiotropium (a long-acting muscarinic antagonist), or placebo. The patients were categorized according to the sputum eosinophil level (

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الوصول الحر: https://escholarship.org/uc/item/8kk8t5ndTest

المؤلفون: Baker, Anna M, Holbrook, Janet T, Yohannes, Abebaw M, Eakin, Michelle N, Sugar, Elizabeth A, Henderson, Robert J, Casper, Anne S, Kaminsky, David A, Rea, Alexis L, Mathews, Anne M, Que, Loretta G, Ramsdell, Joe W, Gerald, Lynn B, Wise, Robert A, Hanania, Nicola A, Hanania, Nicola, Sockrider, Marianna, Bertrand, Laura, Atik, Mustafa, Lopez, Blanca A, Reibman, Joan, DiMango, Emily, Rogers, Linda, Carapetyan, Karen, Rivera, Kristina, Scheuerman, Melissa, Fiorino, Elizabeth, Bryce-Robinson, Newel, Green, Deanna, Noveck, Robert, Foss, Catherine, Ghidorzi, Jessica, Wang, Zongyao, Pangborn, Elise, Robertson, V Susan, Eberlein, Nicholas, Stiles, Jane, Land, Michael, Vickery, Brian, Wu, Eveline, Jaggers, Denise, Allen, Stephanie, Mervin-Blake, Sabrena, Smith, Lewis, Kalhan, Ravi, Moy, James, Naureckas, Edward, Hixon, Jenny, Gonsalves, Zenobia, Zagaja, Virginia, Kustwin, Jennifer, Xu, Ben, Matthews, Thomas, Robinson, Lucius, Singh, Noopur, Happel, Kyle, Sandi, Marie C, Graham, Jennifer M, Sullivan, Katelyn, Poretta, Elizabeth, Katial, Rohit, Hoyte, Flavia, Rojas, Maria, Castro, Mario, Bacharier, Leonard B, Sumino, Kaharu, Yusen, Roger D, Tarsi, Jaime J, Patterson, Brenda, Montgomery, Terri, Busk, Michael, Weiss, Debra, Sundblad, Kimberly, Irvin, Charles, Dixon, Anne E, Teneback, Charlotte, Kanagalingam, Jothi, Burns, Stephanie M, Dwinell, Kathleen, Goodwin, James L, Brown, Mark A, Carr, Tara F, Berry, Cristine E, Bime, Christian, Goforth, Mark A, Ryan, Elizabeth A, Wences, Jesus A, Lopez, Silvia L, Priefert, Janette C, Provencio-Dean, Natalie S, Ogas, Destinee R, Bloss, Valerie R, Wasserman, Stephen I, Soler, Xavier T, Kinninger, Katie H, Martineau, Amber J

المصدر: Annals of the American Thoracic Society. 15(8)

مصطلحات موضوعية: Biomedical and Clinical Sciences, Clinical Sciences, Lung, Mental Health, Brain Disorders, Chronic Obstructive Pulmonary Disease, Clinical Research, Mental health, Respiratory, Good Health and Well Being, test anxiety scale, chronic obstructive pulmonary disease, anxiety, psychometric properties, American Lung Association Airways Clinical Research Centers, Cardiovascular medicine and haematology, Clinical sciences

الوصف: Rationale: Anxiety is a common comorbidity of chronic obstructive pulmonary disease (COPD) that is associated with higher morbidity and mortality. We evaluated three anxiety screening questionnaires: the Generalized Anxiety Disorder 7-Item Scale (GAD-7), the Hospital Anxiety and Depression Scale Anxiety subscale (HADS-A), and the Anxiety Inventory for Respiratory Disease (AIR).Objectives: To evaluate and compare the test performance characteristics of three anxiety screening questionnaires, using the Mini-International Neuropsychiatric Interview (MINI), version 7.0, as the "gold standard."Methods: Individuals with COPD were recruited at 16 centers. The MINI and questionnaires were administered by trained research coordinators at an in-person visit and readministered by telephone 2-4 weeks later. A composite score for the presence of any Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V) anxiety disorder was computed, based on the MINI as the gold standard, compared with a participant screening positive on self-report measures for these analyses.Results: Two hundred and twenty eligible individuals with COPD were enrolled; 219 completed the study. Eleven percent were identified as having a DSM-V anxiety disorder, based on the MINI. Elevated anxiety symptoms based on questionnaires were 38% for the AIR, 30% for the GAD-7, and 20% for the HADS-A. Area under the receiver operating characteristic curve (AUC) was highest for the GAD-7 (0.78; 95% confidence interval [CI], 0.69-0.87), followed by the HADS-A (0.74; 95% CI, 0.64-0.84) and the AIR (0.66; 95% CI, 0.56-0.76). The AUC for the GAD-7 was significantly greater than for the AIR (P = 0.014). Sensitivity was not statistically different among the questionnaires: 77% for the GAD-7, 63% for the HADS-A, and 66% for the AIR. The HADS-A had the highest specificity, 85%, which was significantly higher than that of the GAD-7 (77%; P

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الوصول الحر: https://escholarship.org/uc/item/29z1g511Test

المؤلفون: Leonard, Amanda, Bailey, Julianna, Bruce, Amanda, Jia, Shijing, Stein, Adam, Fulton, Judith, Helmick, Meagan, Litvin, Marina, Patel, Alpa, Powers, Kate E., Reid, Elizabeth, Sankararaman, Senthilkumar, Clemm, Cristen, Reno, Kim, Hempstead, Sarah E., DiMango, Emily

المصدر: Journal of Cystic Fibrosis ; volume 22, issue 5, page 788-795 ; ISSN 1569-1993

مصطلحات موضوعية: Pulmonary and Respiratory Medicine, Pediatrics, Perinatology and Child Health

الإتاحة: https://doi.org/10.1016/j.jcf.2023.05.010Test
https://api.elsevier.com/content/article/PII:S1569199323001406?httpAccept=text/xmlTest
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