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5. Periocular Triamcinolone vs. Intravitreal Triamcinolone vs. Intravitreal Dexamethasone Implant for the Treatment of Uveitic Macular Edema: The PeriOcular vs. INTravitreal corticosteroids for uveitic macular edema (POINT) Trial.

Author

Thorne, Jennifer E, Sugar, Elizabeth A, Holbrook, Janet T, Burke, Alyce E, Altaweel, Michael M, Vitale, Albert T, Acharya, Nisha R, Kempen, John H, Jabs, Douglas A, and Multicenter Uveitis Steroid Treatment Trial Research Group

Subjects
Multicenter Uveitis Steroid Treatment Trial Research Group, Humans, Uveitis, Dexamethasone, Triamcinolone Acetonide, Drug Implants, Glucocorticoids, Tomography, Optical Coherence, Treatment Outcome, Drug Administration Routes, Retrospective Studies, Follow-Up Studies, Adolescent, Adult, Aged, Aged, 80 and over, Middle Aged, Female, Male, Macular Edema, Young Adult, Intravitreal Injections, Clinical Research, Clinical Trials and Supportive Activities, Eye Disease and Disorders of Vision, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Clinical Sciences, Opthalmology and Optometry, Public Health and Health Services, Ophthalmology & Optometry
Abstract

PurposeTo evaluate the comparative effectiveness of 3 regional corticosteroid injections for uveitic macular edema (ME): periocular triamcinolone acetonide (PTA), intravitreal triamcinolone acetonide (ITA), and the intravitreal dexamethasone implant (IDI).DesignMulticenter, randomized clinical trial.ParticipantsPatients with uveitic ME.MethodsPatients were randomized 1:1:1 to receive 1 of the 3 therapies. Patients with bilateral ME were assigned the same treatment for both eyes.Main outcome measuresThe primary outcome was the proportion of baseline (PropBL) central subfield thickness (CST) at 8 weeks (CST at 8 weeks/CST at baseline) assessed with OCT by masked readers. Secondary outcomes included ≥20% improvement and resolution of ME, best-corrected visual acuity (BCVA), and intraocular pressure (IOP) events over 24 weeks.ResultsAll treatment groups demonstrated improved CST during follow-up. At 8 weeks, each group had clinically meaningful reductions in CST relative to baseline (PropBL: 0.77, 0.61, and 0.54, respectively, which translates to reductions of 23%, 39%, and 46% for PTA, ITA, and IDI, respectively). Intravitreal triamcinolone acetonide (PropBL ITA/PropBL PTA, hazard ratio [HR], 0.79; 99.87% confidence interval [CI], 0.65-0.96) and IDI (PropBL IDI/PropBL PTA, HR, 0.69; 99.87% CI, 0.56-0.86) had larger reductions in CST than PTA (P < 0.0001). Intravitreal dexamethasone implant was noninferior to ITA at 8 weeks (PropBL IDI/PropBL ITA, HR, 0.88; 99.87% CI, 0.71-1.08). Both ITA and IDI treatments also were superior to PTA treatment in improving and resolving uveitic ME. All treatment groups demonstrated BCVA improvement throughout follow-up. Both ITA and IDI groups had improvements in BCVA that was 5 letters greater than in the PTA group at 8 weeks (P < 0.004). The risk of having IOP ≥24 mmHg was higher in the intravitreal treatment groups compared with the periocular group (HR, 1.83; 95% CI, 0.91-3.65 and HR, 2.52; 95% CI, 1.29-4.91 for ITA and IDI, respectively); however, there was no significant difference between the 2 intravitreal treatment groups.ConclusionsIntravitreal triamcinolone acetonide and the IDI were superior to PTA for treating uveitic ME with modest increases in the risk of IOP elevation. This risk did not differ significantly between intravitreal treatments.

Published
2019

7. Test Performance Characteristics of the AIR, GAD-7 and HADS-Anxiety Screening Questionnaires for Anxiety in Chronic Obstructive Pulmonary Disease

Author

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, and Martineau, Amber J

Subjects
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
Abstract

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

Published
2018

8. Biomarkers of Type 2 Airway Inflammation as Predictors of Loss of Asthma Control During Step-Down Therapy for Well-Controlled Disease: The Long-Acting Beta-Agonist Step-Down Study (LASST)

Author

Bose, Sonali, Bime, Christian, Henderson, Robert J., Blake, Kathryn V., Castro, Mario, DiMango, Emily, Hanania, Nicola A., Holbrook, Janet T., Irvin, Charles G., Kraft, Monica, Peters, Stephen P., Reibman, Joan, Sugar, Elizabeth A., Sumino, Kaharu, Wise, Robert A., and Rogers, Linda

Published
2020
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9. Dissociations of the Fluocinolone Acetonide Implant: The Multicenter Uveitis Steroid Treatment (MUST) Trial and Follow-up Study

Author

Holbrook, Janet T, Sugar, Elizabeth A, Burke, Alyce E, Vitale, Albert T, Thorne, Jennifer E, Davis, Janet L, Jabs, Douglas A, Jaffe, Glenn J, Branchaud, Brenda, Hahn, Paul, Koreen, Larry, Lad, Eleonora M, Lin, Phoebe, Martel, Joseph Nissim, Serrano, Neha, Skalak, Cindy, Vajzovic, Lejla, Baer, Claxton, Bryant, Joyce, Chavala, Sai, Cusick, Michael, Day, Shelley, Dayani, Pouya, Ehlers, Justis, Kesen, Muge, Lee, Annie, Melamud, Alex, Qureshi, Jawad A, Scott, Adrienne Williams, See, Robert F, Shuler, Robert K, Wood, Megan, Yeh, Steven, Fernandes, Alcides, Gibbs, Deborah, Leef, Donna, Martin, Daniel F, Srivastava, Sunil, Dunn, James P, Begum, Hosne, Boring, Jeff, Brotherson, Kristen L, Burkholder, Bryn, Butler, Nicholas J, Cain, Dennis, Cook, Mary A, Emmert, David, Graul, Janis R, Herring, Mark, Laing, Ashley, Leung, Theresa G, Mahon, Michael C, Moradi, Ahmafreza, Nwankwo, Antonia, Ostheimer, Trucian L, Reed, Terry, Arnold, Ellen, Barnabie, Patricia M, Belair, Marie-Lynn, Bolton, Stephen G, Brodine, Joseph B, Brown, Diane M, Brune, Lisa M, Galor, Anat, Gan, Theresa, Jacobowitz, Adam, Kapoor, Meera, Kedhar, Sanjay, Kim, Stephen, Leder, Henry A, Livingston, Alison G, Morton, Yavette, Nolan, Kisten, Peters, George B, Soto, Priscilla, Stevenson, Ricardo, Tarver-Carr, Michelle, Wang, Yue, Foster, C Stephen, Anesi, Stephen D, Bruner, Linda, Ceron, Olga, Hinkle, David M, Persons, Nancy, Wentworth, Bailey, Acevedo, Sarah, Anzaar, Fahd, Cesca, Tom, Contero, Angelica, Fitzpatrick, Kayleigh, Goronga, Faith, Johnson, Jyothir, Lebron, Karina Q, Marvell, Danielle, Morgan, Chandra, Patel, Nita, Pinto, Jennifer, Siddique, Sana S, Sprague, Janet, and Yilmaz, Taygan

Subjects
Clinical Trials and Supportive Activities, Brain Disorders, Eye Disease and Disorders of Vision, Bioengineering, Clinical Research, Prevention, Neurosciences, Eye, Adolescent, Adult, Aged, Aged, 80 and over, Drug Implants, Equipment Failure, Female, Fluocinolone Acetonide, Follow-Up Studies, Foreign-Body Migration, Glucocorticoids, Humans, Intravitreal Injections, Male, Middle Aged, Postoperative Complications, Reoperation, Risk Factors, Time Factors, Uveitis, Visual Acuity, Multicenter Uveitis Steroid Treatment (MUST) Trial Research Group, Clinical Sciences, Opthalmology and Optometry, Public Health and Health Services, Ophthalmology & Optometry
Abstract

PurposeTo describe fluocinolone acetonide implant dissociations in the Multicenter Uveitis Steroid Treatment (MUST) Trial.DesignRandomized clinical trial with extended follow-up.MethodsReview of data collected on the first implant in the eye(s) of participants. Dissociation was defined as the drug pellet no longer being affixed to the strut and categorized as spontaneous or surgically related.ResultsA total of 250 eyes (146 patients) had at least 1 implant placed. Median follow-up time after implant placement was 6 years (range 0.5-9.2 years). Thirty-four dissociations were reported in 30 participants. There were 22 spontaneous events in 22 participants; 6-year cumulative risk of a spontaneous dissociation was 4.8% (95% confidence interval [CI]: 2.4%-9.1%). The earliest event occurred 4.8 years after placement. Nine of 22 eyes with data had a decline in visual acuity ≥5 letters temporally related to the dissociation. Thirty-nine implant removal surgeries were performed, 33 with replacement. Twelve dissociations were noted during implant removal surgeries in 10 participants (26%, 95% CI 15%-48%); 5 of these eyes had a decline in visual acuity ≥5 letters after surgery. The time from implant placement to removal surgery was longer for the surgeries at which dissociated implants were identified than for those without one (5.7 vs 3.7 years, P < .001). Overall, visual acuity declined 15 or more letters from pre-implant values in 22% of affected eyes; declines were frequently associated with complications of uveitis or its treatment.ConclusionThere is an increasing risk of dissociation of Retisert implants during follow-up; the risk is greater with removal/exchange surgeries, but the risk of both spontaneous and surgically related events increases with longevity of the implants. In 22% of affected eyes visual acuity declined by 15 letters. In the context of eyes with moderate to severe uveitis for years, this rate is not unexpected.

Published
2016

10. Factors Predicting Visual Acuity Outcome in Intermediate, Posterior, and Panuveitis: The Multicenter Uveitis Steroid Treatment (MUST) Trial

Author

Kempen, John H, Van Natta, Mark L, Altaweel, Michael M, Dunn, James P, Jabs, Douglas A, Lightman, Susan L, Thorne, Jennifer E, Holbrook, Janet T, Jaffe, Glenn J, Branchaud, Brenda, Hahn, Paul, Koreen, Larry, Lad, Eleonora M, Lin, Phoebe, Martel, Joseph Nissim, Serrano, Neha, Skalak, Cindy, Vajzovic, Lejla, Baer, Claxton, Bryant, Joyce, Chavala, Sai, Cusick, Michael, Day, Shelley, Dayani, Pouya, Ehlers, Justis, Kesen, Muge, Lee, Annie, Melamud, Alex, Qureshi, Jawad A, Scott, Adrienne Williams, See, Robert F, Shuler, Robert K, Wood, Megan, Yeh, Steven, Fernandes, Alcides, Gibbs, Deborah, Leef, Donna, Martin, Daniel F, Srivastava, Sunil, Begum, Hosne, Boring, Jeff, Brotherson, Kristen L, Burkholder, Bryn, Butler, Nicholas J, Cain, Dennis, Cook, Mary A, Emmert, David, Graul, Janis R, Herring, Mark, Laing, Ashley, Leung, Theresa G, Mahon, Michael C, Moradi, Ahmafreza, Nwankwo, Antonia, Ostheimer, Trucian L, Reed, Terry, Arnold, Ellen, Barnabie, Patricia M, Belair, Marie-Lynn, Bolton, Stephen G, Brodine, Joseph B, Brown, Diane M, Brune, Lisa M, Galor, Anat, Gan, Theresa, Jacobowitz, Adam, Kapoor, Meera, Kedhar, Sanjay, Kim, Stephen, Leder, Henry A, Livingston, Alison G, Morton, Yavette, Nolan, Kisten, Peters, George B, Soto, Priscilla, Stevenson, Ricardo, Tarver-Carr, Michelle, Wang, Yue, Foster, C Stephen, Anesi, Stephen D, Bruner, Linda, Ceron, Olga, Hinkle, David M, Persons, Nancy, Wentworth, Bailey, Acevedo, Sarah, Anzaar, Fahd, Cesca, Tom, Contero, Angelica, Fitzpatrick, Kayleigh, Goronga, Faith, Johnson, Jyothir, Lebron, Karina Q, Marvell, Danielle, Morgan, Chandra, Patel, Nita, Pinto, Jennifer, Siddique, Sana S, and Sprague, Janet

Subjects
Clinical Trials and Supportive Activities, Clinical Research, Eye Disease and Disorders of Vision, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Eye, Aged, Drug Implants, Female, Follow-Up Studies, Glucocorticoids, Humans, Male, Middle Aged, Panuveitis, Time Factors, Tomography, Optical Coherence, Treatment Outcome, Visual Acuity, Multicenter Uveitis Steroid Treatment (MUST) Trial Research Group, Clinical Sciences, Opthalmology and Optometry, Public Health and Health Services, Ophthalmology & Optometry
Abstract

PurposeTo identify factors associated with best-corrected visual acuity (BCVA) presentation and 2-year outcome in 479 intermediate, posterior, and panuveitic eyes.DesignCohort study using randomized controlled trial data.MethodsMulticenter Uveitis Steroid Treatment (MUST) Trial masked BCVA measurements at baseline and at 2 years follow-up used gold-standard methods. Twenty-three clinical centers documented characteristics per protocol, which were evaluated as potential predictive factors for baseline BCVA and 2-year change in BCVA.ResultsBaseline factors significantly associated with reduced BCVA included age ≥50 vs 10 vs grade 0; cataract; macular thickening; and exudative retinal detachment. Over 2 years, eyes better than 20/50 and 20/50 or worse at baseline improved, on average, by 1 letter (P = .52) and 10 letters (P < .001), respectively. Both treatment groups and all sites of uveitis improved similarly. Factors associated with improved BCVA included resolution of active AC cells, resolution of macular thickening, and cataract surgery in an initially cataractous eye. Factors associated with worsening BCVA included longer duration of uveitis (6-10 or >10 vs

Published
2015

11. Effect of a Soy Isoflavone Supplement on Lung Function and Clinical Outcomes in Patients With Poorly Controlled Asthma: A Randomized Clinical Trial

Author

Smith, Lewis J, Kalhan, Ravi, Wise, Robert A, Sugar, Elizabeth A, Lima, John J, Irvin, Charles G, Dozor, Allen J, and Holbrook, Janet T

Subjects
Complementary and Integrative Health, Pediatric, Lung, Asthma, Clinical Research, Nutrition, Clinical Trials and Supportive Activities, Prevention, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Respiratory, Adolescent, Adult, Child, Dietary Supplements, Double-Blind Method, Female, Forced Expiratory Volume, Genistein, Humans, Isoflavones, Male, Middle Aged, Phytotherapy, Plant Extracts, Soybean Proteins, Young Adult, American Lung Association Asthma Clinical Research Centers, Medical and Health Sciences, General & Internal Medicine
Abstract

ImportanceSoy isoflavone supplements are used to treat several chronic diseases, although the data supporting their use are limited. Some data suggest that supplementation with soy isoflavone may be an effective treatment for patients with poor asthma control.ObjectiveTo determine whether a soy isoflavone supplement improves asthma control in adolescent and adult patients with poorly controlled disease.Design, setting, and participantsMulticenter, randomized, double-blind, placebo-controlled trial conducted between May 2010 and August 2012 at 19 adult and pediatric pulmonary and allergy centers in the American Lung Association Asthma Clinical Research Centers network. Three hundred eighty-six adults and children aged 12 years or older with symptomatic asthma while taking a controller medicine and low dietary soy intake were randomized, and 345 (89%) completed spirometry at week 24.InterventionsParticipants were randomly assigned to receive soy isoflavone supplement containing 100 mg of total isoflavones (n=193) or matching placebo (n=193) in 2 divided doses administered daily for 24 weeks.Main outcomes and measuresThe primary outcome measure was change in forced expiratory volume in the first second (FEV1) at 24 weeks. Secondary outcome measures were symptoms, episodes of poor asthma control, Asthma Control Test score (range, 5-25; higher scores indicate better control), and systemic and airway biomarkers of inflammation.ResultsMean changes in prebronchodilator FEV1 over 24 weeks were 0.03 L (95% CI, -0.01 to 0.08 L) in the placebo group and 0.01 L (95% CI, -0.07 to 0.07 L) in the soy isoflavone group, which were not significantly different (P = .36). Mean changes in symptom scores on the Asthma Control Test (placebo, 1.98 [95% CI, 1.42-2.54] vs soy isoflavones, 2.20 [95% CI, 1.53-2.87]; positive values indicate a reduction in symptoms), number of episodes of poor asthma control (placebo, 3.3 [95% CI, 2.7-4.1] vs soy isoflavones, 3.0 [95% CI, 2.4-3.7]), and changes in exhaled nitric oxide (placebo, -3.48 ppb [95% CI, -5.99 to -0.97 ppb] vs soy isoflavones, 1.39 ppb [95% CI, -1.73 to 4.51 ppb]) did not significantly improve more with the soy isoflavone supplement than with placebo. Mean plasma genistein level increased from 4.87 ng/mL to 37.67 ng/mL (P

Published
2015

16. Examining the association of habitual e-cigarette use with inflammation and endothelial dysfunction in young adults: The VAPORS-Endothelial function study

Author

Boakye+, Ellen, primary, Uddin+, S. M. Iftekhar, additional, Osuji, Ngozi, additional, Meinert, Jill, additional, Obisesan, Olufunmilayo H., additional, Mirbolouk, Mohammadhassan, additional, Tasdighi, Erfan, additional, El-Shahawy, Omar, additional, Erhabor, John, additional, Osei, Albert D., additional, Rajan, Tanuja, additional, Patatanian, Michael, additional, Holbrook, Janet T., additional, Bhatnagar, Aruni, additional, Biswal, Shyam S., additional, and Blaha, Michael J., additional

Published
2023
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17. Efficacy and Tolerability of Zinc Acetate for Treatment of Chronic Refractory Cough: Pilot Randomized Futility Trial

Author

Balasubramanian, Aparna, primary, Holbrook, Janet T., additional, Canning, Brendan J., additional, Que, Loretta G., additional, Castro, Mario, additional, Make, Barry J., additional, Rogers, Linda, additional, Busk, Michael F., additional, Rea, Alexis, additional, McCook-Veal, Ashley A., additional, He, Jiaxian, additional, McCormack, Meredith C., additional, and Wise, Robert A., additional

Published
2023
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19. Factors Predicting Visual Acuity Outcome in Intermediate, Posterior, and Panuveitis: The Multicenter Uveitis Steroid Treatment (MUST) Trial

Author

Jaffe, Glenn J., Branchaud, Brenda, Hahn, Paul, Koreen, Larry, Lad, Eleonora (Nora) M., Lin, Phoebe, Martel, Joseph Nissim, Serrano, Neha (Shah), Skalak, Cindy, Vajzovic, Lejla, Baer, Claxton, Bryant, Joyce, Chavala, Sai, Cusick, Michael, Day, Shelley, Dayani, Pouya, Ehlers, Justis, Kesen, Muge, Lee, Annie, Melamud, Alex, Qureshi, Jawad A., Scott, Adrienne Williams, See, Robert F., Shuler, Robert K., Wood, Megan, Yeh, Steven, Fernandes, Alcides, Gibbs, Deborah, Leef, Donna, Martin, Daniel F., Srivastava, Sunil, Dunn, James P., Begum, Hosne, Boring, Jeff, Brotherson, Kristen L., Burkholder, Bryn, Butler, Nicholas J., Cain, Dennis, Cook, Mary A., Emmert, David, Graul, Janis R., Herring, Mark, Laing, Ashley, Leung, Theresa G., Mahon, Michael C., Moradi, Ahmafreza, Nwankwo, Antonia, Ostheimer, Trucian L., Reed, Terry, Arnold, Ellen, Barnabie, Patricia M., Belair, Marie-Lynn, Bolton, Stephen G., Brodine, Joseph B., Brown, Diane M., Brune, Lisa M., Galor, Anat, Gan, Theresa, Jacobowitz, Adam, Kapoor, Meera, Kedhar, Sanjay, Kim, Stephen, Leder, Henry A., Livingston, Alison G., Morton, Yavette, Nolan, Kisten, Peters, George B., Soto, Priscilla, Stevenson, Ricardo, Tarver-Carr, Michelle, Wang, Yue, Foster, C. Stephen, Anesi, Stephen D., Bruner, Linda, Ceron, Olga, Hinkle, David M., Persons, Nancy, Wentworth, Bailey, Acevedo, Sarah, Anzaar, Fahd, Cesca, Tom, Contero, Angelica, Fitzpatrick, Kayleigh, Goronga, Faith, Johnson, Jyothir, Lebron, Karina Q., Marvell, Danielle, Morgan, Chandra, Patel, Nita, Pinto, Jennifer, Siddique, Sana S., Sprague, Janet, Yilmaz, Taygan, Sen, H. Nida, Bono, Michael, Cunningham, Denise, Hayes, Darryl, Koutsandreas, Dessie, Nussenblatt, Robert B., Sherry, Patti R., Short, Gregory L., Smith, Wendy, Temple, Alana, Bamji, Allison, Coleman, Hanna, Davuluri, Geetaniali, Faia, Lisa, Gottlieb, Chloe, Jirawuthiworavong, Guy V., Lew, Julie C., Mercer, Richard, Obiyor, Dominic, Perry, Cheryl H., Potapova, Natalia, Weichel, Eric, Wroblewski, Keith J., Latkany, Paul A., Coonan, Corinne, Honda, Andrea, Lorenzo-Latkany, Monica, Masini, Robert, Morell, Susan, Nguyen, Angela, Badamo, Jason, Boyd, Kenneth M., Enos, Matthew, Gallardo, Jenny, Jarczynski, Jacek, Lee, Ji Yun, McGrosky, Mirjana, Nour, Ann, Sanchez, Meredith, Steinberg, Kate, Stawell, Richard J., Breayley, Lisa, D'Sylva, Carly, Glatz, Elizabeth, Hodgson, Lauren, Lim, Lyndell, Ling, Cecilia, McIntosh, Rachel, Morrison (Ewing), Julie, Newton, Andrew, Sanmugasundram, Sutha, Smallwood, Richard, Zamir, Ehud, Hunt, Nicola, Jones, Lisa, Koukouras, Ignatios, Williams, Suzanne, Merrill, Pauline T., Carns, Danielle, Richine, Len, Voskuil-Marre, Denise L., Woo, Kisung, Gaynes, Bruce, Giannoulis, Christina, Hulvey, Pam, Kernbauer, Elaine, Khan, Heena S., Levine, Sarah J., Toennessen, Scott, Tonner, Eileen, Wang, Robert C., Aguado, Hank, Arceneaux, Sally, Duignan, Karen, Fish, Gary E., Hesse, Nick, Jaramillo, Diana, Mackens, Michael, Arnwine, Jean, Callanan, David, Cummings, Kimberly, Gray, Keith, Howden, Susie, Mutz, Karin, Sanchez, Brenda, Lightman, Susan, Ismetova, Filis, Prytherch, Ashley, Seguin-Greenstein, Sophie, Tomkins, Oren, Bar, Asat, Edwards, Kate, Joshi, Lavanish, Moraji, Jiten, Samy, Ahmed, Stubbs, Timothy, Taylor, Simon, Towler, Hamish, Tronnberg, Rebecca, Holland, Gary N., Almanzor, Robert D., Castellanos, Jose, Hubschman, Jean Pierre, Johiro, Ann K., Kukuyev, Alla, Levinson, Ralph D., McCannel, Colin A., Ransome, Susan S., Gonzales, Christine R., Gupta, Anurag, Kalyani, Partho S., Kapamajian, Michael A., Kappel, Peter J., Arcinue, Cheryl, Chuang, Janne, Barteselli, Giulio, Currie, Glenn, Mendoza, Veronica, Powell, Debbie, Clark, Tom, Cochran, Denine E., Freeman, William R., Hedaya, Joshua, Kemper, Tiara, Kozak, Igor, LeMoine, Jacqueline M., Loughran, Megan E., Magana, Luzandra, Mojana, Francesca, Morrison, Victoria, Nguyen, Vivian, Oster, Stephen F., Acharya, Nisha, Clay, David, Lee, Salena, Lew, Mary, Margolis, Todd P., Stewart, Jay, Wong, Ira G., Brown, Debra, Khouri, Claire M., Goldstein, Debra A., Birnbaum, Andrea, Degillio, Andrea, Rosa, Gemma De la, Ramirez, Carmen, Simjanowski, Evica, Skelly, Mariner, Castro-Malek, Anna L., Crooke, Catherine E., Huntley, Melody, Nash, Katrina, Niec, Marcia, Pyatetsky, Dimitry, Ramirez, Misel, Rozenbajgier, Zuzanna, Tessler, Howard H., Davis, Janet L., Albini, Thomas A., Chin, Marie, Castaño, Daniela, Elizondo, Ariana, Ho, Macy, Kovach, Jaclyn L., Lin, Richard C-S., Mandelcorn, Efrem, Nguyen, Jackie K-D., Pacini, Aura, Pineda, Susan, Pinto, David A., Rebimbas, Jose, Stepien, Kimberly E., Teran, Claudia, Elner, Susan G., Bernard, Hillary, Fournier, Linda, Godsey, Lindsay, Goings, Linda, Hackel, Richard, Hesselgrave, Moella, Jayasundera, K. Thiran, Prusak, Robert, Titus, Pamela, Bergeron, Melissa, Blosser, Reneé, Brown, Rebecca, Chrisman-McClure, Carrie, Gothrup, Julie R., Saxe, Stephen J., Sizemore, Deanna, Kempen, John H., Berger, James, Drossner, Sheri, DuPont, Joan C., Maguire, Albert M., Petner, Janice, Engelhard, Stephanie, Hopkins, Tim, Lo, Jonathan, McCall, Dawn, McRay, Monique, Salvo, Rebecca, Will, Daniel, Xu, Wei, Windsor, Elizabeth, Weeney, Laurel, Pavan, Peter R., Albritton, Ken, Leto, JoAnn, Madow, Brian, Mayor, Lori, Pautler, Scott E., Saxon, Wyatt, Soto, Judy, Goldstein, Burton, Klukoff, Amy, Lambright, Lucy, McDonald, Kim, Ortiz, Maria, Scymanky, Susan, Szalay, Dee Dee, Rao, Narsing, Davis, Tamara, Douglass, Jackie, Linton, Judith, Padilla, Margaret, Ramos, Sylvia, Rao, Narsing A., Aguirre, Alexia, Chong, Lawrence, Cisneros, Lupe, Corona, Elizabeth, Eliott, Dean, Fawzi, Amani, Garcia, Jesse, Khurana, Rahul, Lim, Jennifer, Mead, Rachel, Tsai, Julie H., Vitale, Albert, Bernstein, Paul S., Carlstrom, Bonnie, Gilman, James, Hanseen, Sandra, Morris, Paula, Ramirez, Diana, Wegner, Kimberley, Sheppard, John D., Anthony, Brianne, Casper, Amber, Felix-Kent, Lisa, Fernandez, Jeanette, Johnson, Tari, Scoper, Stephen V., Cole, R. Denise, Crawford, Nancy, Franklin, Lisa, Hamelin, Krista, Martin, Jen, Marx, Rebecca, Schultz, Gregory, Webb, Joseph, Yeager, Pamela, Kim, Rosa Y., Benz, Matthew S., Brown, David M., Chen, Eric, Fish, Richard H., Kegley, Eric, Shawver, Laura, Wong, Tien P., De La Garza, Rebecca, Friday (Hay), Shayla, Rao, P. Kumar, Adcock, Eve, Apte, Rajendra S., Baladenski, Amy, Curtis, Rhonda, Gould, Sarah, Hebden, Amanda, Kambarian, Jamie, Meyer, Charla, Pistorius, Sam, Quinn, Melanie, Rathert, Greg, Blinder, Kevin J., Hartz, Ashley, Light, Pam, Shah, Gaurav K., VanGelder, Russell, Jabs, Douglas A., Altaweel, Michael M., Holbrook, Janet T., Kurinij, Natalie, Brown, Diane, Prusakowski, Nancy, Thorne, Jennifer E., Hubbard, Larry, Wittes, Janet, Barlow, William E., Hochberg, Marc, Lyon, Alice T., Palestine, Alan G., Simon, Lee S., Rosenbaum, James T., Smith, Harmon, Davis, Janet, Thorne, Jennifer, Acharya, Nisha R., Vitale, Albert T., Boring, Jeffrey A., Alexander, Judith, Ng, Wai Ping, Friedman, David S., Adler, Anna, Burke, Alyce, Katz, Joanne, Reed, Susan, Ansari, Husam, Cohen, Nicholas, Modak, Sanjukta, Sugar, Elizabeth A., Burke, Alyce E., Drye, Lea T., Van Natta, Mark L., Frick, Kevin, Katz, JoAnn, Louis, Thomas A., Shade, David, Pascual, Karen, Slutsky-Sanon, Jill S., Allen, Amanda, Glomp, Colby, Hilal, Yasmin, Nieves, Melissa A., Stevens, Maria, Abreu, Francis, Casper, Anne Shanklin, Ewing, Cathleen, Hart, Adante, Lears, Andrea, Li, Shirley, Meinert, Jill, Morrison, Vinnette, Nowakowski, Deborah, Reyes, Girlie, Shade, Dave M., Smith, Jacqueline, Steuernagle, Karen, Van Natta, Mark, Venugopal, Vidya, Yu, Tsung, Chen, Paul, Collins, Karen, Dodge, John, Frick, Kevin D., Jackson, Rosetta, Jimenez, Christian, Landers, Ariel, Livingston, Hope, Meinert, Curtis L., Rayapudi, Sobharani, Shen, Weijiang, Shiflett, Charles, Smith, Rochelle, Tieman, Ada, Tonascia, James A., Zheng, Richard, Allan, James, Benz, Wendy K., Domalpally, Amitha, Johnson, Kristine A., Myers, Dawn J., Won Pak, Jeong, Reimers, James L., Chambers, Geoffrey, Christianson, Debra J., Fleischli, Margaret A., Freund, Jacquelyn, Gama, Vonnie, Gangaputra, Sapna, Glander, Kathleen E., Goulding, Anne, Hafford, Dennis, Harris, Susan E., Hubbard, Larry D., Joyce, Jeffrey M., Kruse, Christina N., Nagle, Lauren, Padden-Lechten, Gwyn E., Pohlman, Alyson, Remm, Amy, Shaw, Ruth A., Sivesind, Peggy, Thayer, Dennis, Treichel, Erika, Warren, Kelly J., Watson, Sheila M., Webster, Mary K., White, James K., Wilhelmson, Tara, Zhang, Grace, and Lightman, Susan L.

Published
2015
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21. Roflumilast May Increase Risk of Exacerbations When Used to Treat Poorly Controlled Asthma in People with Obesity

Author

Dixon, Anne E., primary, Que, Loretta G., additional, Kalhan, Ravi, additional, Dransfield, Mark T., additional, Rogers, Linda, additional, Gerald, Lynn B., additional, Kraft, Monica, additional, Krishnan, Jerry A., additional, Johnson, Olivia, additional, Hazucha, Heather, additional, Roy, Gem, additional, Holbrook, Janet T., additional, and Wise, Robert A., additional

Published
2023
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24. Impact of the Coronavirus Disease 2019 Pandemic on Physical and Mental Health of Patients With COPD: Results From a Longitudinal Cohort Study Conducted in the United States (2020-2021)

Author

Zhang, William Z., LaBedz, Stephanie L., Holbrook, Janet T., Gangemi, Andrew, Baalachandran, Ramasubramanian, Eakin, Michelle N., Wise, Robert A., and Sumino, Kaharu

Subjects
Pulmonary and Respiratory Medicine, Origianl Research
Abstract

Background: Patients with chronic obstructive pulmonary disease (COPD) are at higher risk for severe coronavirus disease 2019 (COVID-19). From the pandemic’s onset there has been concern regarding effects on health and well-being of high-risk patients. Methods: This was an ancillary study to the Losartan Effects on Emphysema Progression (LEEP) Trial and was designed to collect descriptive information longitudinally about the health and wellbeing of COPD patients who were enrolled in a clinical trial. Participants were interviewed by telephone about their health status every 2 weeks and their mental health, knowledge, and behaviors every 8 weeks from June 2020 to April 2021. There were no pre-specified hypotheses. Results: We enrolled 157 of the 220 participants from the parent LEEP trial. Their median age was 69 years, 55% were male, and 82% were White; median forced expiratory volume in 1 second (FEV(1))% predicted was 48%. Nine confirmed COVID-19 infections were reported, 2 resulting in hospitalization. Rates of elevated anxiety or depressive symptoms were 8% and 19% respectively in June 2020 and remained relatively stable during follow-up. By April 2021, 85% of participants said they were “very likely” to receive a vaccine; 91% were vaccinated (≥1 dose) by the end of December 2021. Conclusion: Our select cohort of moderate to severe COPD patients who were well integrated into a health care network coped well with the COVID-19 pandemic. Few participants were diagnosed with COVID-19, levels of depression and anxiety were stable, most adopted accepted risk reduction behaviors, and did not become socially isolated; most were vaccinated by the end of 2021.

Published
2022

26. Comprehension of Clinical Trial Information by Caregivers and Adolescents Delivered via Multimedia Video versus Conventional Practice: A Nonrandomized Controlled Trial (Preprint)

Author

Blake, Kathryn Vick, primary, Antal, Holly, additional, Bunnell, H. Timothy, additional, He, Jiaxian, additional, Henderson, Robert, additional, Holbrook, Janet T, additional, McCahan, Suzanne M, additional, Pennington, Chris, additional, Rogers, Linda, additional, Shade, David, additional, Sugar, Elizabeth A, additional, Taylor, Alexandra, additional, Wise, Robert A, additional, and Wysocki, Tim, additional

Published
2022
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28. Clinical Trial of Losartan for Pulmonary Emphysema: Pulmonary Trials Cooperative Losartan Effects on Emphysema Progression Clinical Trial

Author

Wise, Robert A., primary, Holbrook, Janet T., additional, Brown, Robert H., additional, Criner, Gerard J., additional, Dransfield, Mark T., additional, He, Jiaxian, additional, Henderson, Robert J., additional, Kaminsky, David A., additional, Kaner, Robert J., additional, Lazarus, Stephen C., additional, Make, Barry J., additional, McCormack, Meredith C., additional, Neptune, Enid R., additional, and Que, Loretta G., additional

Published
2022
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34. Subgroup Analysis of a Randomized Trial of the Effects of Positive Messaging on Patient-Reported Outcomes with Asthma – Effect of Obesity

Author

Mathews,Anne M, Riley,Isaretta, Henderson,Robert, Holbrook,Janet T, Lang,Jason E, Dixon,Anne E, Wise,Robert A, Que,Loretta G, Mathews,Anne M, Riley,Isaretta, Henderson,Robert, Holbrook,Janet T, Lang,Jason E, Dixon,Anne E, Wise,Robert A, and Que,Loretta G

Abstract

Anne M Mathews,1 Isaretta Riley,1 Robert Henderson,2 Janet T Holbrook,2 Jason E Lang,1 Anne E Dixon,3 Robert A Wise,4 Loretta G Que1 1Department of Medicine, Division of Pulmonary and Critical Care Medicine, Duke University, Durham, NC, USA; 2Department of Epidemiology, Johns Hopkins Center for Clinical Trials and Evidence Synthesis, Baltimore, MD, USA; 3Department of Medicine, Division of Pulmonary Disease and Critical Care Medicine, University of Vermont, Burlington, VT, USA; 4Department of Medicine, Division of Pulmonary and Critical Care Medicine, Johns Hopkins University, Baltimore, MD, USACorrespondence: Loretta G Que, P.O. Box 2629 DUMC, 279 Research Drive, Durham, NC, 27710, USA, Tel +1 919 6818551, Fax +1 919 668 0494, Email loretta.que@duke.eduObjective: Asthma in obese patients represents a specific phenotype that is associated with increased symptoms, more frequent and severe exacerbations, reduced responsiveness to treatment, and decreased quality of life. Marketing and placebos have been shown to alter subjective responses to interventions in both asthma and obesity. We evaluated obesity as a potential treatment effect modifier of the effects enhanced drug messaging or placebos on subjective asthma outcomes.Methods: We conducted a secondary analysis of a multicenter, randomized clinical trial that studied the effect of messaging and placebos on asthma outcomes. A total of 601 participants were randomized (1:1:1:1:1) to one of 5 groups: enhanced messaging with montelukast or placebo, neutral messaging with montelukast or placebo, or usual care and followed for 4 weeks after randomization. We compared baseline characteristics by obesity status for 600 participants with data on body weight. Obesity was evaluated as an effect modifier for enhanced messaging (versus neutral messaging) and on placebo effects (versus usual care) in 362 participants assigned to a placebo group or usual care for three asthma questionnaires: Asthma Control Questionnaire, Asthma

Published
2022

39. Comprehension by Caregivers and Adolescents of Clinical Trial Information Delivered via Multimedia Video Versus Conventional Practice: Nonrandomized Controlled Trial.

Author

Blake, Kathryn V, Antal, Holly, Bunnell, H Timothy, He, Jiaxian, Henderson, Robert, Holbrook, Janet T, McCahan, Suzanne M, Pennington, Chris, Rogers, Linda, Shade, David, Sugar, Elizabeth A, Taylor, Alexandra, Wise, Robert A, and Wysocki, Tim

Subjects
CAREGIVERS, INFORMED consent (Medical law), FACE-to-face communication, MULTIMEDIA systems, CLINICAL trials
Abstract

Background: Research participants often misunderstand the required elements of informed consent information, whether provided in written or oral format. Informed consent instruments with embedded evidence-based learning theory principles administered in multimedia electronic formats may improve comprehension and retention. Objective: This study aims to determine whether study information comprehension and retention using an interactive multimedia video consent process was noninferior to comprehension and retention after an in-person face-to-face interaction with a conventional written consent document for caregivers and adolescents enrolled in a clinical trial. Methods: Participants were caregivers and children aged 12 to 17 years who were enrolled in a clinical trial of asthma treatment. Consent information was presented as a multimedia web-based video consent interaction or as a conventional written consent document with in-person interaction between the prospective participants and the study staff. The trial used a parallel nonrandomized noninferiority design that compared the 2 consent methods. Caregivers and adolescents completed a 17-item open-ended comprehension questionnaire (score range 17-51) at enrollment and at the end of the study 20 weeks later. Comprehension and retention were compared between the consent formats. Noninferiority was established if the 95% CI upper bound of the difference in scores (conventional format minus web-based) was less than the noninferiority margin of 2.4; superiority was established if the upper bound of the CI was <0. Results: In total, 54 caregiver and adolescent dyads completed the interactive multimedia web-based video consent, and 25 dyads completed the conventional consent. Overall, 33% (26/79) of all adolescents were Black, 57% (45/79) were male, and 61% (48/79) had a household income of

Published
2023
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45. The challenge of addressing obesity in people with poorly controlled asthma

Author

Dixon, Anne E., primary, Blake, Kathryn V., additional, DiMango, Emily A., additional, Dransfield, Mark T., additional, Feemster, Laura C., additional, Johnson, Olivia, additional, Roy, Gem, additional, Hazucha, Heather, additional, Harvey, Jean, additional, McCormack, Meredith C., additional, Wise, Robert A., additional, and Holbrook, Janet T., additional

Published
2021
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