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Item Considerations for applying bioethics norms to a biopharmaceutical industry setting(BMC, 2021-03-25) Van Campen, Luann E.; Poplazarova, Tatjana; Therasse, Donald G.; Turik, Michael; Biopharmaceutical Bioethics Working Group; Office of Research ComplianceBackground: The biopharmaceutical industry operates at the intersection of life sciences, clinical research, clinical care, public health, and business, which presents distinct operational and ethical challenges. This setting merits focused bioethics consideration to complement legal compliance and business ethics efforts. However, bioethics as applied to a biopharmaceutical industry setting often is construed either too broadly or too narrowly with little examination of its proper scope. Main text: Any institution with a scientific or healthcare mission should engage bioethics norms to navigate ethical issues that arise from the conduct of biomedical research, delivery of clinical care, or implementation of public health programs. It is reasonable to assume that while bioethics norms must remain constant, their application will vary depending on the characteristics of a given setting. Context "specification" substantively refines ethics norms for a particular discipline or setting and is an expected, needed and progressive ethical activity. In order for this activity to be meaningful, the scope for bioethics application and the relevant contextual factors of the setting need to be delineated and appreciated. This paper defines biopharmaceutical bioethics as: the application of bioethics norms (concepts, principles, and rules) to the research, development, supply, commercialization, and clinical use of biopharmaceutical healthcare products. It provides commentary on this definition, and presents five contextual factors that need to be considered when applying bioethics norms to a biopharmaceutical industry setting: (1) dual missions; (2) timely and pragmatic guidance; (3) resource stewardship; (4) multiple stakeholders; and (5) operational complexity. Conclusion: Understanding the scope of the biopharmaceutical enterprise and contextual factors of a biopharmaceutical industry setting is foundational for the application of bioethics norms. Establishing a common language and approach for biopharmaceutical bioethics will facilitate breadth and depth of discussion and subsequent implementation to benefit patients, the healthcare system and society.Item Facility-level program components leading to population impact: a coincidence analysis of obesity treatment options within the Veterans Health Administration(Oxford University Press, 2022) Damschroder, Laura J.; Miech, Edward J.; Freitag, Michelle B.; Evans, Richard; Burns, Jennifer A.; Raffa, Susan D.; Goldstein, Michael G.; Annis, Ann; Spohr, Stephanie A.; Wiitala, Wyndy L.; Emergency Medicine, School of MedicineObesity is a well-established risk factor for increased morbidity and mortality. Comprehensive lifestyle interventions, pharmacotherapy, and bariatric surgery are three effective treatment approaches for obesity. The Veterans Health Administration (VHA) offers all three domains but in different configurations across medical facilities. Study aim was to explore the relationship between configurations of three types of obesity treatments, context, and population impact across VHA using coincidence analysis. This was a cross-sectional analysis of survey data describing weight management treatment components linked with administrative data to compute population impact for each facility. Coincidence analysis was used to identify combinations of treatment components that led to higher population impact. Facilities with higher impact were in the top two quintiles for (1) reach to eligible patients and (2) weight outcomes. Sixty-nine facilities were included in the analyses. The final model explained 88% (29/33) of the higher-impact facilities with 91% consistency (29/32) and was comprised of five distinct pathways. Each of the five pathways depended on facility complexity-level plus factors from one or more of the three domains of weight management: comprehensive lifestyle interventions, pharmacotherapy, and/or bariatric surgery. Three pathways include components from multiple treatment domains. Combinations of conditions formed "recipes" that lead to higher population impact. Our coincidence analyses highlighted both the importance of local context and how combinations of specific conditions consistently and uniquely distinguished higher impact facilities from lower impact facilities for weight management.Item Linguistic Perspectives on the Development of Intercultural Competence in Telecollaboration.(The original publisher of this article is:Language Learning & Technology (LLT). The definitive publisher-authenticated version of Julie A. Bellz. "Linguistic Perspectives on the Development of Intercultural Competence in Telecollaboration". Language Learning & Technology 7, no.2 (2003): 68-117, is available online at:[BREAK][LINK]http://llt.msu.edu/vol7num2/default.html[/LINK][BREAK]Access to the original article may require subscription and authorized logon ID/password. Please check University Library resources before purchasing an article via the publisher. Questions on finding the original article via our databases? Ask a librarian:[LINK]http://www.ulib.iupui.edu/research/askalibrarian[/LINK], 2003-05) Belz, Julie A. (Julie Anne)It is widely reported (e.g., Belz & Müller-Hartmann, 2002; Kern, 1996; Kinginger, in press; Warschauer & Kern, 2000) that the goals of telecollaborative language study are the development of foreign language (FL) linguistic competence and the facilitation of intercultural competence (e.g., Bausch, Christ, & Krumm, 1997; Bredella & Delanoy, 1999; Byram, 1997; Harden & Witte, 2000). Whereas evaluations of the impact of telecollaboration on FL linguistic competence have been based on structural descriptions of learner discourse from the earliest days of research in this field (e.g., Beauvois, 1992; Chun, 1994; Kelm, 1992; Kern, 1995; Pelletieri, 2000; Sotillo, 2000; Warschauer, 1996), discussions of intercultural competence in the same configuration have been characterized primarily in alinguistic terms. These have included analyst-sensitive content analyses of learner interaction in telecollaboration, post-semester interviews with learners who have participated in telecollaborative projects, and attitudinal surveys of these same learners (e.g., Fischer, 1998; Furstenberg, Levet, English, & Maillet, 2001; Lomicka, 2001; Müller-Hartmann, 1999; von der Emde, Schneider, & Kötter, 2001; Warschauer, 1998; see, however, Belz, 2001; Belz & Müller-Hartmann, 2003). In general, the fields of foreign language learning and teaching (FLL&T) have neither advocated nor presented linguistically critical interpretations of the development of intercultural competence in telecollaboration. In this paper, I present a detailed case study of the development of intercultural competence (or lack thereof) in a German-American e-mail partnership by examining the electronic interaction produced in this exchange within the framework of appraisal theory (e.g., Eggins & Slade, 1997; Martin, 2000; White, 1998), a Hallidayian-inspired linguistic approach to the investigation of evaluative language.Item A Post-development Perspective on mHealth -- An Implementation Initiative in Malawi(IEEE, 2013-03-18) Purkayastha, Saptarshi; Manda, Tiwonge Davis; Sanner, Terje AkselWhile the sheer number of mHealth implementations around the world have been increasing dramatically, authoritative voices on global health have tried to put the focus on quantifiable evaluations and comparisons of these projects (e.g. health outcomes, cost savings, efficiency) in order to channel donor funds and investments into proven and scalable solutions. Drawing on empirical data from an mHealth implementation in Malawi we argue that quantitative evaluation of health interventions often assumes a top-down and limited view on the developmental impact of mHealth. Through our action-research involvement with facility-based reporting of routine health data through mobile phones, we conclude that developmental impacts of mHealth are local and each locale experience a different developmental impact depending on the context of use and available resources. The paper contrasts global concerns for quantifiable development with local priorities with respect to mHealth projects and information system (IS) interventions in health more broadly.