Challenges Associated with Multi-institutional Multi-site Clinical Trial Collaborations: Lessons from a Diabetes Self-Management Interventions Study in Primary Care

Purpose: Project management for multi-institutional, multi-site clinical trials poses significant challenges. We describe the response to challenges encountered in a 5-year National Institutes of Health multi-institutional 7-site randomized controlled trial of type 2 diabetes (T2DM) self-management interventions study. Methods: The collaborating institutions consisted of a large 220,000-member integrated healthcare system and a university academic health science center partner. The clinical team comprised the principal investigator and research coordinators covering 6 of the 7 clinical sites, while the academic team comprised the co-principal investigator, coinvestigators, and other research and clinical coordination staff. Subjects recruited for the study had a glycosylated hemoglobin ≥ 7.5 within the last 6 months and received primary care at the participating clinics. Patients who met the inclusion criteria were consented at private orientation meetings, randomized into one of 4 study arms, and followed every 6 months over a 24-month period for data collection. Results: The encountered challenges concerned: 1) communication across the multiple clinic sites; 2) multiinstitutional coordinator training; 3) multiple record-keeping methods; 4) clinical access for academic personnel; 5) unanticipated clinical coordinator turnover; 6) subject recruitment and retention; and 7) multiple Institutional Review Boards (IRBs). Solutions included conducting full team weekly or bimonthly research meetings, coordinator crosstraining, adding study-specific templates with downloadable fields, developing a protocol for working with single point of contact in each clinic, securing commitment from the centralized clinical system to dedicate coordinator(s) to the project for the duration of the study period, setting explicit monthly recruitment goals for each clinic, and establishing a lead IRB up-front. Conclusion: Our challenges reflect the complexity of clinical trial collaborations across clinical and academic partners. Of critical importance to the success of clinical/academic collaborations is the commitment by all institutions for advance determination of communication strategies, IRB processes, records access and storage systems, and online training needs. Trial Registration Number/Site: NCT01221090, https://clinicaltrials.govThe open access fee for this work was funded through the Texas A&M University Open Access to Knowledge (OAK) Fund

Rural Healthy People 2020

Rural Healthy People 2020 (RHP2020) is a result of the work of several researchers, graduate assistants, dedicated project staff, and the guidance of our national RHP2020 Expert Advisory Board. Over a decade ago, the Health Resources and Services Administration’s Office of Rural Health funded the two-volume Rural Healthy People 2010 – the result of a rural-focused survey of Healthy People 2010 priorities and objectives. TeThis served as a foundational starting point for identifying rural health priorities and objectives for the decade.Texas A&M Health Science Center School of Public Health and the Florida State University College of Medicin

How She Haunts: Missed Endings, the Fragmentary, and the Female Figure in British Romanticism

In this dissertation I discuss a relatively small grouping of fragmentary texts by Coleridge (Sibylline Leaves, “The Three Graves,” “Christabel,” and “Kubla Khan”), De Quincey (Suspiria de Profundis), and Keats (“La Belle Dame Sans Merci” and Lamia). In critical discussions of the Romantic fragment, it is most often referred to as incomplete, lacking closure, and unintentionally so. The fragments I have chosen to include transcend such a reading of lack and embrace a perpetuation of possibility. My claim is not that these are exemplary British Romantic fragments but rather that they lend themselves to a more detailed analysis of how fragmentary aspects influence a text and its readerly responses precisely because they are fragments that are concerned with, or are aware of, their fragmentary nature. They are different from fragments that have become fragments through accident or lack of intention, or even texts that are fragmentary but do not engage this fragmentary nature as a main focus. The texts in my dissertation are in many ways both fragmentary in nature and about being fragmentary in theme. No one has much noted the fragmentary elements within fragments, nor have scholars noticed the female figures’ roles in relation to the fragmentary. My contention is that these female figures haunt their texts precisely through their fragmentary incompleteness and that they embody the fragmentary. Repetition of sounds and landscapes throughout the texts are consumed by or subsumed into, coalescing ultimately into the woman. They are aspects, parts, of her. They are described in the same way that she is described. We are introduced first to these cycles and repetitions of parts of sounds and parts of landscapes (all incomplete and fragmentary, breaking off or not finding ends), and by the time we meet the female figure, she is familiar to us because we have been reading about aspects of her. Sigmund Freud’s notion of the uncanny features in my analysis; his concept deals with repetition and, through repetition, a disturbing familiarity. Biography plays a role in my dissertation, although it is by no means a main focus. I show that in the texts under discussion the female figure is created by a male author’s loss, she fills an absence and is part of his mourning process. The loss is not necessarily a concrete loss (a sibling dying, for example), and may be a loss of control, of ambition, of public regard, of a hoped-for trajectory, etc. The male author uses the woman he writes as a receptacle and container for what he finds incomprehensible and frightening. She is closely related to these strongly-felt emotions; the emotions themselves are troubling and alienating. The female becomes the entity into which he writes this felt alienation, creating an alienating figure. The parts of himself that he does not understand become translated into aspects of the woman. My observation that female figures are intimately related to the fragmentary in the texts leads me to another aspect of the fragmentary that has been overlooked by critics: the female figure’s relationship to language that suggests ongoingness and incompletion. The descriptions of action surrounding her are nearly all ongoing. These ongoing actions are ultimately what drive a continual contemplation of the text long after we have finished reading it. I argue that the text itself finds the ending that it wants to, that it precisely seeks a way to not find resolution though the writing on the page ceases. In ending without resolution, the plot proceeds indefinitely in the reader’s mind, refusing to choose any of the imaginable outcomes. The storyline is suspended; the actions within the text are on loop because the reader has never been told that they stop. She is haunted