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2. Efficacy and safety of a single dose of casirivimab and imdevimab for the prevention of COVID-19 over an 8-month period: a randomised, double-blind, placebo-controlled trial

Author

Chani, Achint, Adepoju, Adebiyi, Mahmood, Adnan, Mortagy, Aisha, Dupljak, Ajla, Baum, Alina, Brown, Alison, Froment, Amy, Hooper, Andrea, Margiotta, Andrea, Bombardier, Andrew, Islam, Anita, Smith, Anne, Dhillon, Arvinder, McMillian, Audra, Breazna, Aurora, Aslam, Ayesha, Carpentino, Barabara, Kowal, Bari, Siliverstein, Barry, Horel, Benjamin, Zhu, Bo, Musser, Bret, Bush, Brian, Head, Brian, Snow, Brian, Zhu, Bryan, Debray, Camille, Phillips, Careta, Simiele, Carmella, Lee, Carol, Nienstedt, Carolyn, Trbovic, Caryn, Chan, Casey (Kuo-Chen), Elliott, Catherine, Fish, Chad, Ni, Charlie, Polidori, Christa, Enciso, Christine, Caira, Christopher, Powell, Christopher, Kyratsous, Christos A., Baum, Cliff, McDonald, Colin, Leigh, Cynthia, Pan, Cynthia, Wolken, Dana, Manganello, Danielle, Liu, David, Stein, David, Weinreich, David M., Hassan, Dawlat, Gulabani, Daya, Fix, Deborah, Leonard, Deborah, Sarda, Deepshree, Bonhomme, Denise, Kennedy, Denise, Darcy, Devin, Barron, Dhanalakshmi, Hughes, Diana, Rofail, Diana, Kaur, Dipinder, Ramesh, Divya, Bianco, Dona, Cohen, Donna, Forleo-Neto, Eduardo, Jean-Baptiste, Edward, Bukhari, Ehsan, Doyle, Eileen, Bucknam, Elizabeth, Labriola-Tomkins, Emily, Nanna, Emily, Huffman O'Keefe, Esther, Gasparino, Evelyn, Fung, Evonne, Isa, Flonza, To, Fung-Yee, Herman, Gary, Yancopoulos, George D., Bellingham, Georgia, Sumner, Giane, Moggan, Grainne, Power, Grainne, Zeng, Haixia, Mariveles, Hazel, Gonzalez, Heath, Kang, Helen, Noor, Hibo, Minns, Ian, Heirman, Ingeborg, Peszek, Izabella, Donohue, James, Rusconi, Jamie, Austin, Janice, Parrino, Janie, Yo, Jeannie, McDonnell, Jenna, Hamilton, Jennifer D., Boarder, Jessica, Wei, Jianguo, Yu, Jingchun, Malia, Joanne, Tucciarone, Joanne, Tyler-Gale, Jodie, Davis, John D., Strein, John, Cohen, Jonathan, Meyer, Jonathan, Ursino, Jordan, Im, Joseph, Tramaglini, Joseph, Wolken, Joseph, Potter, Kaitlyn, Scacalossi, Kaitlyn, Naidu, Kamala, Browning, Karen, Rutkowski, Karen, Yau, Karen, Woloshin, Katherine, Lewis-Amezcua, Kelly, Turner, Kenneth, Dornheim, Kimberly, Chiu, Kit, Mohan, Kosalai, McGuire, Kristina, Macci, Kristy, Ringleben, Kurt, Mohammadi, Kusha, Foster, Kyle, Knighton, Latora, Lipsich, Leah, Darling, Lindsay, Boersma, Lisa, Cowen, Lisa, Hersh, Lisa, Jackson, Lisa, Purcell, Lisa, Sherpinsky, Lisa, Lai, Livia, Faria, Lori, Geissler, Lori, Boppert, Louise, Fiske, Lyra, Dickens, Marc, Mancini, Marco, Leigh, Maria C., O'Brien, Meagan P., Batchelder, Michael, Klinger, Michael, Partridge, Michael, Tarabocchia, Michel, Wong, Michelle, Rodriguez, Mivianisse, Albizem, Moetaz, O'Byrne, Muriel, Braunstein, Ned, Sarkar, Neena, Stahl, Neil, Deitz, Nicole, Memblatt, Nicole, Shah, Nirav, Kumar, Nitin, Herrera, Olga, Adedoyin, Oluchi, Yellin, Ori, Snodgrass, Pamela, Floody, Patrick, D'Ambrosio, Paul, Gao, Paul (Xiaobang), Hou, Peijie, Hearld, Philippa, Li, Qin, Kitchenoff, Rachel, Ali, Rakiyya, Iyer, Ramya, Chava, Ravikanth, Alaj, Rinol, Pedraza, Rita, Hamlin, Robert, Hosain, Romana, Gorawala, Ruchin, White, Ryan, Yu, Ryan, Fogarty, Rylee, Dass, S. Balachandra, Bollini, Sagarika, Ganguly, Samit, DeCicco, Sandra, Patel, Sanket, Cassimaty, Sarah, Somersan-Karakaya, Selin, McCarthy, Shane, Henkel, Sharon, Ali, Shazia, Geila Shapiro, Shelley, Kim, Somang, Nossoughi, Soraya, Bisulco, Stephanie, Elkin, Steven, Long, Steven, Sivapalasingam, Sumathi, Irvin, Susan, Wilt, Susan, Min, Tami, Constant, Tatiana, Devins, Theresa, DiCioccio, Thomas, Norton, Thomas, Bernardo, Travis, Chuang, Tzu-Chien, Wei, Victor (Jianguo), Nuce, Vinh, Battini, Vishnu, Caldwell, Wilson, Gao, Xiaobang, Chen, Xin, Tian, Yanmei, Khan, Yasmin, Zhao, Yuming, Kim, Yunji, Dye, Bonnie, Hurt, Christopher B., Burwen, Dale R., Barouch, Dan H., Burns, David, Brown, Elizabeth, Bar, Katharine J., Marovich, Mary, Clement, Meredith, Cohen, Myron S., Sista, Nirupama, Barnabas, Ruanne V., Zwerski, Sheryl, Herman, Gary A, O'Brien, Meagan P, Chan, Kuo-Chen, Bar, Katharine J, Barnabas, Ruanne V, Barouch, Dan H, Cohen, Myron S, Hurt, Christopher B, Burwen, Dale R, Marovich, Mary A, Musser, Bret J, Davis, John D, Turner, Kenneth C, Hooper, Andrea T, Hamilton, Jennifer D, Subramaniam, Danise, Kyratsous, Christos A, DiCioccio, A Thomas, Yancopoulos, George D, and Weinreich, David M

Published
2022
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14. Genre-based literacy pedagogy : the nature and value of genre knowledge in teaching and learning writing on a university first year media studies course

Author

Donohue, James Peter Michael

Subjects
302.22440711, X342 Academic studies in Higher Education, literacy, writing, academic writing
Abstract

In the teaching and learning of literacy, descriptions of text have a problematic status as a result of the growing understanding of literacy as both a cognitive process and a social practice. In the teaching of academic subjects at university, student text is not usually an object of study. The research in this thesis draws on a language based theory oflearning to place textual description at the centre of the teaching and learning of both literacy and academic subjects at university. Participant observation and practice-based research methods were used to implement a form of text-oriented literacy teaching and to explore its compatibility with processes and practices orientations to literacy. Over an eighteen month period, systemic functional grammar was used to investigate and describe the texts of a film studies classroom and the descriptions were used in genre based literacy pedagogy. The effects of the pedagogy are measured in terms of students' performance in an end of course assignment, students' accounts of their writing processes, and student and subject-tutor perception of the text description and the pedagogy. In the thesis, a linguistic description of a key curriculum genre -a Taxonomic Film Analysis -is presented. An account is given of the pedagogy by means of which this essay genre was represented in the film studies classroom as a realisation of choices from linguistic, conceptual and activity systems. Systemic functional grammar-based text description is seen to have provided a means whereby a literacy tutor could collaborate with a subject tutor to provide a subject-specific form of literacy teaching which was evaluated as relevant by students and tutors. The account and the evaluation help to clarify the role that description of text can play in relation to processes and practices ofliteracy use in the teaching and learning of literacy in a film studies classroom and have implications for the teaching and learning of literacy at university more generally.

Published
2002

15. Bridging the “Know-Do” Gaps in Five Non-Communicable Diseases Using a Common Framework Driven by Implementation Science

Author

Donohue,James F, Elborn,J Stuart, Lansberg,Peter, Javed,Afzal, Tesfaye,Solomon, Rugo,Hope, Duddi,Sita Ratna Devi, Jithoo,Niraksha, Huang,Pai-Hui, Subramaniam,Kannan, Ramanjinappa,Nagendra, Koltun,Arkady, Melamed,Shari, and Chan,Juliana CN

Subjects
Journal of Healthcare Leadership
Abstract

James F Donohue,1 J Stuart Elborn,2 Peter Lansberg,3 Afzal Javed,4 Solomon Tesfaye,5 Hope Rugo,6 Sita Ratna Devi Duddi,7,8 Niraksha Jithoo,9 Pai-Hui Huang,10 Kannan Subramaniam,11 Nagendra Ramanjinappa,12 Arkady Koltun,13 Shari Melamed,13 Juliana CN Chan14 1UNC School of Medicine, Chapel Hill, NC, USA; 2Queen’s University, Belfast, UK; 3University Medical Center, Groningen, the Netherlands; 4Warwick Medical School, University of Warwick, Warwick, UK & Pakistan Psychiatric Research Centre, Coventry, UK; 5Sheffield Teaching Hospitals and the University of Sheffield, Sheffield, UK; 6University of California San Francisco Comprehensive Cancer Center, San Francisco, CA, USA; 7International Alliance of Patients’ Organisations, London, United Kingdom; 8DakshamA Health and Education, Delhi, India; 9Viatris Ltd, Johannesburg, South Africa; 10Viatris Pharmaceutical Co., Ltd, Taipei, Taiwan; 11Viatris Ltd, Auckland, New Zealand; 12Viatris Ltd, Bangalore, India; 13Viatris Ltd, Canonsburg, PA, USA; 14Department of Medicine and Therapeutics, Hong Kong Institute of Diabetes and Obesity, Li Ka Shing Institute of Health Sciences, The Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong, Special Administrative Regions of the People’s Republic of ChinaCorrespondence: Juliana CN Chan, Department of Medicine and Therapeutics, Hong Kong Institute of Diabetes and Obesity, Li Ka Shing Institute of Health Sciences, The Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong, Special Administrative Regions of the People’s Republic of China, Tel +852 3505 3138, Email jchan@cuhk.edu.hkAbstract: According to the United Nations High-Level Meeting 2018, five non-communicable diseases (NCDs) including cardiovascular diseases, chronic respiratory diseases, diabetes mellitus, cancer, and mental health conditions accounted for two-thirds of global deaths. These five NCDs share five common risk factors including tobacco use, unhealthy diets, physical inactivity, alcohol use, and air pollution. Low- and middle-income countries (LMICs) face larger burden of NCDs than high-income countries (HICs), due to differences in ecological, technological, socioeconomic and health system development. Based on high-level evidence albeit mainly from HICs, the burden caused by NCDs can be reduced by affordable medicines and best practices. However, “know-do” gaps, ie, gaps between what we know in science and what we do in practice, has limited the impact of these strategies, especially in LMICs. Implementation science advocates the use of robust methodologies to evaluate sustainable solutions in health, education and social care aimed at informing practice and policies. In this article, physician researchers with expertise in NCDs reviewed the common challenges shared by these five NCDs with different clinical courses. They explained the principles of implementation science and advocated the use of an evidence-based framework to implement solutions focusing on early detection, prevention and empowerment, supplemented by best practices in HICs and LMICs. These successful stories can be used to motivate policymakers, payors, providers, patients and public to co-design frameworks and implement context-relevant, multi-component, evidence-based practices. In pursuit of this goal, we propose partnership, leadership, and access to continuing care as the three pillars in developing roadmaps for addressing the multiple needs during the journey of a person with or at risk of these five NCDs. By transforming the ecosystem, raising awareness and aligning context-relevant practices and policies with ongoing evaluation, it is possible to make healthcare accessible, affordable and sustainable to reduce the burden of these five NCDs.Keywords: non-communicable diseases, know-do gaps, implementation science, evidence-based practices, healthcare policies

Published
2023

16. A multicenter, randomized, double-blind dose-ranging study of glycopyrrolate/formoterol fumarate fixed-dose combination metered dose inhaler compared to the monocomponents and open-label tiotropium dry powder inhaler in patients with moderate-to-severe COPD

Author

Tashkin, Donald P., Martinez, Fernando J., Rodriguez-Roisin, Roberto, Fogarty, Charles, Gotfried, Mark, Denenberg, Michael, Gottschlich, Gregory, Donohue, James F., Orevillo, Chad, Darken, Patrick, St Rose, Earl, Strom, Shannon, Fischer, Tracy, Golden, Michael, and Reisner, Colin

Published
2016
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29. Current Perspectives of Pharmacotherapies for COPD.

Author

Pleasants, Roy A. and Donohue, James F.

Subjects
HEART disease complications, NITRIC oxide analysis, BIOTHERAPY, BIOMARKERS, DRUG efficacy, EOSINOPHILS, GLUCOCORTICOIDS, ADRENOCORTICAL hormones, ASTHMA, DIGITAL technology, INDIVIDUALIZED medicine, INVESTIGATIONAL drugs, CELL receptors, BRONCHODILATOR agents, OBSTRUCTIVE lung diseases, ALPHA 1-antitrypsin deficiency, INHALATION administration, COMORBIDITY, PHENOTYPES, PATIENT safety, PHOSPHODIESTERASE inhibitors, DISEASE complications
Abstract

Pharmacotherapies and avoidance of environmental/inhaled toxins are core to managing COPD. Compared to the drugs available 50 years ago, there has been substantial progress with COPD pharmacotherapies, but gaps in adherence and inhaler use persist. Personalizing inhaled pharmacotherapies is now possible with digital technologies by objectively documenting adherence and guiding inhaler technique. Another means to improve existing pharmacotherapies is through phenotyping and biomarkers. This is especially important considering the heterogeneity of the disease COPD. Blood eosinophils are now a recommended biomarker to guide use of inhaled corticosteroids and biologics in COPD. On the near horizon, we will see new inhaled medications as dual phosphodiesterase inhibitors, drugs to treat basic protein abnormalities as in alpha-1 antitrypsin deficiency that could have remarkable benefits, and biologic drugs targeting specific cell/mediator types in the COPD population. Characterization of COPD phenotypes, as asthma/COPD overlap and comorbid heart disease are vital to understand how to optimize pharmacotherapies. Importantly, we must determine how to optimize current medications; otherwise, we will repeat the same mistakes with new medications. But as we know so well, as we peel one layer of complexity, we encounter many more questions, all the while dedicated to limiting the burden of COPD. [ABSTRACT FROM AUTHOR]

Published
2023
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30. Investigating the Relationship between the Use of English for Academic Purposes and Academic Attainment

Author

Donohue, James P. and Erling, Elizabeth J.

Abstract

The purpose of this study is to determine whether differences in academic attainment between university students could be correlated with their use of English for academic purposes. Using the diagnostic language assessment procedure known as Measuring the Academic Skills of University Students (MASUS), as well as informal analysis of assignment feedback and interviews with students, students' performance in assignments in three subject areas was investigated. Results confirmed that there was a strong correlation between the overall scores students obtained in the MASUS language assessment and their attainment as represented by their assignment grade. However, analysis of the five separate categories of the MASUS scores showed that only the scores for the category, "use of source material," correlated strongly with student attainment and that the scores on the more explicit language categories, "structure and development of the text," "academic writing style," and "grammar," did not. The paper considers the implications of these findings for future studies of the role of English for academic purposes in students' attainment and for EAP pedagogy. (Contains 1 table.)

Published
2012
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32. Academic Literacies and Systemic Functional Linguistics: How Do They Relate?

Author

Coffin, Caroline and Donohue, James P.

Abstract

Two approaches to English for Academic Purposes (EAP) research and teaching which have arisen in recent years are systemic functional linguistics (SFL) approaches in Australia and elsewhere (e.g. Hood, 2006; Lee, 2010; Woodward-Kron, 2009) and Academic Literacies approaches in the UK and elsewhere (e.g. Lillis & Scott, 2008; Thesen & Pletzen, 2006; Turner, 2004). Although these approaches both draw from ethnographic and sociocultural traditions, they have tended to focus on different aspects of EAP. SFL as a theory of language has employed linguistic analysis to establish the nature of disciplinary discourses and ways of encouraging students to engage in these discourses; research and pedagogy have concentrated on texts, language in use and the language system. Academic Literacies as a research paradigm has maintained a strong commitment to ethnographic investigation and to critiquing dominant academic and institutional practices; methods have concentrated on identifying practices, student identities, and conflicts that individual language users experience in university writing. This article reflects on the two approaches by reviewing their two literatures, uncovering key questions that characterise each, and illuminating similarities and difference in epistemology and methodology. The article concludes by recognising the potential of dialogue and collaboration across the SFL and Academic Literacies research and teaching communities to address current imperatives facing EAP.

Published
2012
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33. Using Systemic Functional Linguistics in Academic Writing Development: An Example from Film Studies

Author

Donohue, James P.

Abstract

On film studies courses, students are asked to treat as objects of study the same films which they may more commonly experience as entertainment. To explore the role of academic writing in this, an action research project was carried out on a university film studies course using a systemic functional linguistics approach. This paper presents a key assessment essay genre, referred to as a "taxonomic film analysis". This genre was analysed drawing on the work of Halliday and Mathiessen (2004), Martin (1992) and Lemke, (1985, 1990), focussing on three aspects: the genre acts performed in the process of analysing film; the conceptual frameworks of film studies knowledge, or "thematic formations" (Lemke, 1993) drawn on and re-constituted in the assignment; the particular ways that language is used to perform these acts and build these thematic formations. For EAP to be relevant to film students, it is proposed that EAP specialists need to engage with these three aspects of film study. This application of SFL in film studies EAP is intended as an illustration of how SFL tools can be used for relevant EAP provision across the HE curriculum. (Contains 5 figures.)

Published
2012
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36. How to Support a One-Handed Economist: The Role of Modalisation in Economic Forecasting

Author

Donohue, James P.

Abstract

Economic forecasting in the world of international finance confronts economists with challenging cross-cultural writing tasks. Producing forecasts in English which convey confidence and credibility entails an understanding of linguistic conventions which typify the genre. A typical linguistic feature of commercial economic forecasts produced by British or US banks is a wide range of modal forms. These can be seen as "hedging" devices, expressing the forecaster's degree of certainty about predictions in the forecast. This article draws on recent accounts of modalisation which elaborate on the notion of "hedging". The article is based on a study of English language forecasts carried out by the author, motivated by the resistance of a group of Dutch economists to using a wide range of modals in their English language forecasts. The study suggested that modalisation in English language forecasts contributes to the performance of three major functions: "Conversation, Discrimination and Organisation." "Conversation" refers to the dialogue--or the appearance of it--constructed by forecasters with their readership and the wider economics community. "Discrimination" refers to the way interpretations of the economy are woven into a plausible construct of the future by foregrounding and backgrounding predictions. "Organisation" refers to the means whereby forecasters construct a text in order to realise the "Conversation" and "Discrimination" effectively.

Published
2006
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45. Revefenacin: A Once-Daily, Long-Acting Bronchodilator For Nebulized Treatment Of COPD

Author

Donohue, James F, Mahler, Donald A, and Sethi, Sanjay

Subjects
bronchodilator, Nebulizers and Vaporizers, LAMA, nebulizer, Review, Muscarinic Antagonists, once daily, Bronchodilator Agents, Pulmonary Disease, Chronic Obstructive, Treatment Outcome, Delayed-Action Preparations, Benzamides, long-acting muscarinic antagonist, inhaled, Humans, Carbamates
Abstract

Bronchodilation with muscarinic antagonists, β2-agonists, and inhaled corticosteroids remains the foundation of pharmaceutical treatment for patients with stable COPD. These drugs are delivered from a variety of devices, including dry powder inhalers, pressurized metered-dose inhalers, soft-mist inhalers, or nebulizers. Nebulized delivery is often preferable in patients who are elderly, are cognitively impaired, are unable to generate sufficient inspiratory force to use their inhaler, have difficulty coordinating hand-breath activity, are too dyspneic to hold their breath for a sufficient time, and/or may be acutely ill. Revefenacin, a once-daily long-acting muscarinic antagonist for nebulization recently approved by the US FDA for the treatment of patients with COPD, was discovered and developed using “duration and lung selectivity-by-design.” This strategy selected a molecule with a high lung-selective index to maximize bronchodilation and limit systemic anti-muscarinic side effects. In early-phase clinical studies, revefenacin for nebulization led to a rapid onset of bronchodilation that was sustained for 24 hrs in patients with moderate to severe COPD. Revefenacin also demonstrated minimal systemic exposure and good tolerability in these studies. Statistically and clinically significant improvements in lung function (ie, peak and/or trough FEV1) relative to placebo were observed with revefenacin in Phase III clinical trials of up to 3 months in patients with moderate to very severe COPD. Revefenacin was well tolerated in Phase III clinical trials with a low incidence of systemic antimuscarinic adverse events, which is consistent with its lung-selective design. There was no evidence of an increased risk of major cardiovascular events. Patient-reported outcome data from clinical trials indicated statistically significant improvements in several disease-specific measures. Revefenacin 175 μg for nebulization provides an effective once-daily treatment option for patients with moderate to very severe COPD who require or prefer nebulized therapy.

Published
2019

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