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  1. Article ; Online: The return of the Traditional Birth Attendant

    Karen Lane / Jayne Garrold

    Journal of Global Health, Vol 6, Iss

    2016  Volume 2

    Abstract: Sub–Saharan Africa and Southern Asia lag behind other regions in the provision of antenatal care and skilled attendance at birth (although typically attended by a family member or villager) and over 32 million of the 40 million births not attended by ... ...

    Abstract Sub–Saharan Africa and Southern Asia lag behind other regions in the provision of antenatal care and skilled attendance at birth (although typically attended by a family member or villager) and over 32 million of the 40 million births not attended by skilled health personnel in 2012 occurred in rural areas. Overall, one–quarter of women in developing nations still birth alone or with a relative to assist them.
    Keywords Traditional birth attendant ; Medicine ; R ; Public aspects of medicine ; RA1-1270
    Language English
    Publishing date 2016-12-01T00:00:00Z
    Publisher Edinburgh University Global Health Society
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  2. Article ; Online: 4 Right care at the right time

    William Bekker / Caitlin Garrett / Heather Gleason / Kathryn Hoehn / Katie Iommazzo / Karen Lane / Benji Mathews / Hilary Radtke / Sara Spilseth / Julie Weegman

    BMJ Open Quality, Vol 10, Iss Suppl

    a care model redesign quality improvement project

    2021  Volume 2

    Keywords Medicine (General) ; R5-920
    Language English
    Publishing date 2021-11-01T00:00:00Z
    Publisher BMJ Publishing Group
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  3. Article ; Online: Using gamification to enhance clinical trial start-up activities

    Karen Lane / Ryan Majkowski / Joshua Gruber / Daniel Amirault / Shannon Hillery / Cortney Wieber / Dixie D Thompson / Jacqueline Huvane / Jordan Bridges / E. Paul Ryu / Lindsay M. Eyzaguirre / Marianne Gildea / Richard E. Thompson / Daniel E. Ford / Daniel Hanley

    Journal of Clinical and Translational Science, Vol

    2022  Volume 6

    Abstract: Abstract Background: The Trial Innovation Network (TIN) is a collaborative initiative within the National Center for Advancing Translational Science (NCATS) Clinical and Translational Science Awards (CTSA) Program. To improve and innovate the conduct of ... ...

    Abstract Abstract Background: The Trial Innovation Network (TIN) is a collaborative initiative within the National Center for Advancing Translational Science (NCATS) Clinical and Translational Science Awards (CTSA) Program. To improve and innovate the conduct of clinical trials, it is exploring the uses of gamification to better engage the trial workforce and improve the efficiencies of trial activities. The gamification structures described in this article are part of a TIN website gamification toolkit, available online to the clinical trial scientific community. Methods: The game designers used existing electronic trial platforms to gamify the tasks required to meet trial start-up timelines to create friendly competitions. Key indicators and familiar metrics were mapped to scoreboards. Webinars were organized to share and applaud trial and game performance. Results: Game scores were significantly associated with an increase in achieving start-up milestones in activation, institutional review board (IRB) submission, and IRB approval times, indicating the probability of completing site activation faster by using games. Overall game enjoyment and feelings that the game did not apply too much pressure appeared to be an important moderator of performance in one trial but had little effect on performance in a second. Conclusion: This retrospective examination of available data from gaming experiences may be a first-of-kind use in clinical trials. There are signals that gaming may accelerate performance and increase enjoyment during the start-up phase of a trial. Isolating the effect of gamification on trial outcomes will depend on a larger sampling from future trials, using well-defined, hypothesis-driven statistical analysis plans.
    Keywords Gamification ; clinical trials ; metrics ; Trial Innovation Network ; trial start-up ; Medicine ; R
    Subject code 629
    Language English
    Publishing date 2022-01-01T00:00:00Z
    Publisher Cambridge University Press
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  4. Article ; Online: Response of the trial innovation network to the COVID-19 pandemic

    Rachel G. Greenberg / Lori Poole / Daniel E. Ford / Daniel Hanley / Harry P. Selker / Karen Lane / J. Michael Dean / Jeri Burr / Paul Harris / Consuelo H. Wilkins / Gordon Bernard / Terri Edwards / Daniel K. Benjamin

    Journal of Clinical and Translational Science, Vol

    2021  Volume 5

    Abstract: Abstract Introduction: The COVID-19 pandemic prompted the development and implementation of hundreds of clinical trials across the USA. The Trial Innovation Network (TIN), funded by the National Center for Advancing Translational Sciences, was an ... ...

    Abstract Abstract Introduction: The COVID-19 pandemic prompted the development and implementation of hundreds of clinical trials across the USA. The Trial Innovation Network (TIN), funded by the National Center for Advancing Translational Sciences, was an established clinical research network that pivoted to respond to the pandemic. Methods: The TIN’s three Trial Innovation Centers, Recruitment Innovation Center, and 66 Clinical and Translational Science Award Hub institutions, collaborated to adapt to the pandemic’s rapidly changing landscape, playing central roles in the planning and execution of pivotal studies addressing COVID-19. Our objective was to summarize the results of these collaborations and lessons learned. Results: The TIN provided 29 COVID-related consults between March 2020 and December 2020, including 6 trial participation expressions of interest and 8 community engagement studios from the Recruitment Innovation Center. Key lessons learned from these experiences include the benefits of leveraging an established infrastructure, innovations surrounding remote research activities, data harmonization and central safety reviews, and early community engagement and involvement. Conclusions: Our experience highlighted the benefits and challenges of a multi-institutional approach to clinical research during a pandemic.
    Keywords Trial innovation network ; COVID-19 ; clinical trial ; SARS-CoV-2 ; CTSA ; Medicine ; R
    Language English
    Publishing date 2021-01-01T00:00:00Z
    Publisher Cambridge University Press
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  5. Article ; Online: Development, implementation, and dissemination of operational innovations across the trial innovation network

    Marisha E. Palm / Terri L. Edwards / Cortney Wieber / Marie T. Kay / Eve Marion / Leslie Boone / Angeline Nanni / Michelle Jones / Eilene Pham / Meghan Hildreth / Karen Lane / Nichol McBee / Daniel K. Benjamin / Gordon R. Bernard / J. Michael Dean / Jamie P. Dwyer / Daniel E. Ford / Daniel F. Hanley / Paul A. Harris /
    Consuelo H. Wilkins / Harry P. Selker

    Journal of Clinical and Translational Science, Vol

    2023  Volume 7

    Abstract: Improving the quality and conduct of multi-center clinical trials is essential to the generation of generalizable knowledge about the safety and efficacy of healthcare treatments. Despite significant effort and expense, many clinical trials are ... ...

    Abstract Improving the quality and conduct of multi-center clinical trials is essential to the generation of generalizable knowledge about the safety and efficacy of healthcare treatments. Despite significant effort and expense, many clinical trials are unsuccessful. The National Center for Advancing Translational Science launched the Trial Innovation Network to address critical roadblocks in multi-center trials by leveraging existing infrastructure and developing operational innovations. We provide an overview of the roadblocks that led to opportunities for operational innovation, our work to develop, define, and map innovations across the network, and how we implemented and disseminated mature innovations.
    Keywords Trial innovation network ; CTSA ; clinical trials ; clinical trial roadblocks ; innovation ; Medicine ; R
    Language English
    Publishing date 2023-01-01T00:00:00Z
    Publisher Cambridge University Press
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  6. Article ; Online: Approaches for enhancing the informativeness and quality of clinical trials

    Karen Lane / Marisha E. Palm / Eve Marion / Marie T. Kay / Dixie Thompson / Mary Stroud / Helen Boyle / Shannon Hillery / Angeline Nanni / Meghan Hildreth / Sarah Nelson / Jeri S. Burr / Terri Edwards / Lori Poole / Salina P. Waddy / Sarah E. Dunsmore / Paul Harris / Consuelo Wilkins / Gordon R. Bernard /
    J. Michael Dean / Jamie Dwyer / Daniel K. Benjamin / Harry P. Selker / Daniel F. Hanley / Daniel E. Ford

    Journal of Clinical and Translational Science, Vol

    Innovations and principles for implementing multicenter trials from the Trial Innovation Network

    2023  Volume 7

    Abstract: One challenge for multisite clinical trials is ensuring that the conditions of an informative trial are incorporated into all aspects of trial planning and execution. The multicenter model can provide the potential for a more informative environment, but ...

    Abstract One challenge for multisite clinical trials is ensuring that the conditions of an informative trial are incorporated into all aspects of trial planning and execution. The multicenter model can provide the potential for a more informative environment, but it can also place a trial at risk of becoming uninformative due to lack of rigor, quality control, or effective recruitment, resulting in premature discontinuation and/or non-publication. Key factors that support informativeness are having the right team and resources during study planning and implementation and adequate funding to support performance activities. This communication draws on the experience of the National Center for Advancing Translational Science (NCATS) Trial Innovation Network (TIN) to develop approaches for enhancing the informativeness of clinical trials. We distilled this information into three principles: (1) assemble a diverse team, (2) leverage existing processes and systems, and (3) carefully consider budgets and contracts. The TIN, comprised of NCATS, three Trial Innovation Centers, a Recruitment Innovation Center, and 60+ CTSA Program hubs, provides resources to investigators who are proposing multicenter collaborations. In addition to sharing principles that support the informativeness of clinical trials, we highlight TIN-developed resources relevant for multicenter trial initiation and conduct.
    Keywords Multicenter trials ; informative trials ; Trial Innovation Network ; study planning ; clinical trial budgets ; clinical trial resources ; Medicine ; R
    Subject code 650
    Language English
    Publishing date 2023-01-01T00:00:00Z
    Publisher Cambridge University Press
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  7. Article ; Online: Decentralized clinical trials in the trial innovation network

    Daniel F. Hanley / Gordon R. Bernard / Consuelo H. Wilkins / Harry P. Selker / Jamie P. Dwyer / J. Michael Dean / Daniel Kelly Benjamin / Sarah E. Dunsmore / Salina P. Waddy / Kenneth L. Wiley / Marisha E. Palm / W. Andrew Mould / Daniel F. Ford / Jeri S. Burr / Jacqueline Huvane / Karen Lane / Lori Poole / Terri L. Edwards / Nan Kennedy /
    Leslie R. Boone / Jasmine Bell / Emily Serdoz / Loretta M. Byrne / Paul A. Harris

    Journal of Clinical and Translational Science, Vol

    Value, strategies, and lessons learned

    2023  Volume 7

    Abstract: New technologies and disruptions related to Coronavirus disease-2019 have led to expansion of decentralized approaches to clinical trials. Remote tools and methods hold promise for increasing trial efficiency and reducing burdens and barriers by ... ...

    Abstract New technologies and disruptions related to Coronavirus disease-2019 have led to expansion of decentralized approaches to clinical trials. Remote tools and methods hold promise for increasing trial efficiency and reducing burdens and barriers by facilitating participation outside of traditional clinical settings and taking studies directly to participants. The Trial Innovation Network, established in 2016 by the National Center for Advancing Clinical and Translational Science to address critical roadblocks in clinical research and accelerate the translational research process, has consulted on over 400 research study proposals to date. Its recommendations for decentralized approaches have included eConsent, participant-informed study design, remote intervention, study task reminders, social media recruitment, and return of results for participants. Some clinical trial elements have worked well when decentralized, while others, including remote recruitment and patient monitoring, need further refinement and assessment to determine their value. Partially decentralized, or “hybrid” trials, offer a first step to optimizing remote methods. Decentralized processes demonstrate potential to improve urban-rural diversity, but their impact on inclusion of racially and ethnically marginalized populations requires further study. To optimize inclusive participation in decentralized clinical trials, efforts must be made to build trust among marginalized communities, and to ensure access to remote technology.
    Keywords Decentralized trials ; hybrid trials ; CTSA ; trial innovation network ; inclusive recruitment ; remote trials ; remote technology ; rural recruitment ; remote recruitment ; remote intervention ; remote data collection ; MyCap ; remote trial monitoring ; Medicine ; R
    Subject code 610
    Language English
    Publishing date 2023-01-01T00:00:00Z
    Publisher Cambridge University Press
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  8. Article ; Online: Safety of intravenous alteplase within 4.5 hours for patients awakening with stroke symptoms.

    Victor C Urrutia / Roland Faigle / Steven R Zeiler / Elisabeth B Marsh / Mona Bahouth / Mario Cerdan Trevino / Jennifer Dearborn / Richard Leigh / Susan Rice / Karen Lane / Mustapha Saheed / Peter Hill / Rafael H Llinas

    PLoS ONE, Vol 13, Iss 5, p e

    2018  Volume 0197714

    Abstract: BACKGROUND:Up to 25% of acute stroke patients first note symptoms upon awakening. We hypothesized that patients awaking with stroke symptoms may be safely treated with intravenous alteplase (IV tPA) using non-contrast head CT (NCHCT), if they meet all ... ...

    Abstract BACKGROUND:Up to 25% of acute stroke patients first note symptoms upon awakening. We hypothesized that patients awaking with stroke symptoms may be safely treated with intravenous alteplase (IV tPA) using non-contrast head CT (NCHCT), if they meet all other standard criteria. METHODS:The SAfety of Intravenous thromboLytics in stroke ON awakening (SAIL ON) was a prospective, open-label, single treatment arm, pilot safety trial of standard dose IV tPA in patients who presented with stroke symptoms within 0-4.5 hours of awakening. From January 30, 2013, to September 1, 2015, twenty consecutive wakeup stroke patients selected by NCHCT were enrolled. The primary outcome was symptomatic intracerebral hemorrhage (sICH) in the first 36 hours. Secondary outcomes included NIH stroke scale (NIHSS) at 24 hours; and modified Rankin Score (mRS), NIHSS, and Barthel index at 90 days. RESULTS:The average age was 65 years (range 47-83); 40% were women; 50% were African American. The average NIHSS was 6 (range 4-11). The average time from wake-up to IV tPA was 205 minutes (range 114-270). The average time from last known well to IV tPA was 580 minutes (range 353-876). The median mRS at 90 days was 1 (range 0-5). No patients had sICH; two of 20 (10%) had asymptomatic ICH on routine post IV tPA brain imaging. CONCLUSIONS:Administration of IV tPA was feasible and may be safe in wakeup stroke patients presenting within 4.5 hours from awakening, screened with NCHCT. An adequately powered randomized clinical trial is needed. CLINICAL TRIAL REGISTRATION:ClinicalTrials.gov NCT01643902.
    Keywords Medicine ; R ; Science ; Q
    Language English
    Publishing date 2018-01-01T00:00:00Z
    Publisher Public Library of Science (PLoS)
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  9. Book: Understanding Annie Proulx

    Rood, Karen Lane

    (Understanding contemporary American literature)

    2001  

    Author's details Karen L. Rood
    Series title Understanding contemporary American literature
    Keywords Regionalism in literature ; Women and literature/History
    Language English
    Size 224 S.
    Publisher Univ. of South Carolina Press
    Publishing place Columbia, SC
    Document type Book
    Note Bibliogr. und Literaturverz. S. [199] - 205 ; Hier auch später erschienene, unveränderte Nachdrucke
    ISBN 1570034028 ; 9781570034022 ; 1570034028
    Database Former special subject collection: coastal and deep sea fishing

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  10. Book: American writers in Paris, 1920 - 1939

    Rood, Karen Lane

    (Dictionary of literary biography ; 4)

    1980  

    Author's details ed. by Karen Lane Rood
    Series title Dictionary of literary biography ; 4
    Language English
    Size XV, 426 S, Ill
    Publisher Gale Research
    Publishing place Detroit, Mich
    Document type Book
    Note A Bruccoli Clark book
    ISBN 0810309165 ; 9780810309166
    Database Former special subject collection: coastal and deep sea fishing

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