scholarly journals Regulatory considerations for prospective patient care registries: lessons learned from the National Neurosurgery Quality and Outcomes Database

2013 ◽  
Vol 34 (1) ◽  
pp. E5 ◽  
Author(s):  
Anthony L. Asher ◽  
Matthew J. McGirt ◽  
Steven D. Glassman ◽  
Rachel Groman ◽  
Dan K. Resnick ◽  
...  

Clinical registries have emerged in the current resource-restricted environment of modern medicine as useful and logical mechanisms for providing health care stakeholders with high-quality data related to the safety, effectiveness, and value of specific interventions. Temporal and qualitative requirements for data acquisition in the context of clinical registries have rapidly expanded as clinicians and other stakeholders increasingly recognize the central importance of this information to the intelligent transformation of health care processes. Despite the potential of more robust clinical data collection efforts to advance the science of care, certain aspects of these newer systems, particularly the prospective, longitudinal acquisition of clinical data and direct patient contact, represent areas of structural overlap between emerging quality improvement efforts and traditional models of human subjects research. This overlap has profound implications for the design and implementation of modern clinical registries. In this paper, the authors describe the evolution of clinical registries as important tools for advancing the science of practice, and review the existing federal regulations that apply to these systems.

2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 3-3
Author(s):  
Roberta Peterson ◽  
Elizabeth Avent ◽  
Zachary Gassoumis ◽  
Jeanine Yonashiro Cho ◽  
Bonnie Olsen

Abstract By U.S. Centers for Disease Control and Prevention estimates, the number of older adults with Alzheimer’s Disease and related dementias (ADRD) is expected to increase 278% by 2060 to affect approximately 13.9 million individuals. Research is needed to not only improve understanding and treatment of ADRD but to also study its effect on the physical, emotional, and psychological well-being of persons with dementia (PWD) and their care partners (CP). However, due to the diminishing cognitive and functional capacities of PWDs associated with the progression of ADRD over time, research efforts are sometimes hampered by a plethora of potential scientific, logistical, ethical, and emotional barriers. This session will introduce an educational approach used to train students who are interested in conducting in-home research among PWDs and their CPs and share lessons learned through the program’s pilot training of undergraduate and graduate students (N=6). Through didactic training, role-playing exercises, and experiential learning processes, trainees are equipped to accompany research project interviewers into the homes of PWD and assist in implementing research protocols. Students receive extensive training in the disease trajectories of ADRD, the impacts of disease on PWDs and their CPs, ways to communicate and interact with PWDs, best practices in promoting the protection and autonomy of human subjects with dementia, and approaches to obtaining quality data for research.


2003 ◽  
Vol 42 (02) ◽  
pp. 185-189 ◽  
Author(s):  
R. Haux ◽  
C. Kulikowski ◽  
A. Bohne ◽  
R. Brandner ◽  
B. Brigl ◽  
...  

Summary Objectives: The Yearbook of Medical Informatics is published annually by the International Medical Informatics Association (IMIA) and contains a selection of excellent papers on medical informatics research which have been recently published (www.yearbook.uni-hd.de). The 2003 Yearbook of Medical Informatics took as its theme the role of medical informatics for the quality of health care. In this paper, we will discuss challenges for health care, and the lessons learned from editing IMIA Yearbook 2003. Results and Conclusions: Modern information processing methodology and information and communication technology have strongly influenced our societies and health care. As a consequence of this, medical informatics as a discipline has taken a leading role in the further development of health care. This involves developing information systems that enhance opportunities for global access to health services and medical knowledge. Informatics methodology and technology will facilitate high quality of care in aging societies, and will decrease the possibilities of health care errors. It will also enable the dissemination of the latest medical and health information on the web to consumers and health care providers alike. The selected papers of the IMIA Yearbook 2003 present clear examples and future challenges, and they highlight how various sub-disciplines of medical informatics can contribute to this.


2021 ◽  
pp. 104973232199864
Author(s):  
Nabil Natafgi ◽  
Olayinka Ladeji ◽  
Yoon Duk Hong ◽  
Jacqueline Caldwell ◽  
C. Daniel Mullins

This article aims to determine receptivity for advancing the Learning Healthcare System (LHS) model to a novel evidence-based health care delivery framework—Learning Health Care Community (LHCC)—in Baltimore, as a model for a national initiative. Using community-based participatory, qualitative approach, we conducted 16 in-depth interviews and 15 focus groups with 94 participants. Two independent coders thematically analyzed the transcripts. Participants included community members (38%), health care professionals (29%), patients (26%), and other stakeholders (7%). The majority considered LHCC to be a viable model for improving the health care experience, outlining certain parameters for success such as the inclusion of home visits, presentation of research evidence, and incorporation of social determinants and patients’ input. Lessons learned and challenges discussed by participants can help health systems and communities explore the LHCC aspiration to align health care delivery with an engaged, empowered, and informed community.


Author(s):  
Elizabeth Lerner Papautsky ◽  
Richard J. Holden ◽  
Rupa S. Valdez ◽  
Jordan Hill ◽  
Janetta Brown

In the 4th panel on the topic of The Patient in Patient Safety, we highlighted topics of current relevance and facilitated a reflection session. The objective was to highlight the ways in which the COVID-19 pandemic has impacted patient ergonomics research and work, with particular focus on safety. After a topic overview, panelists presented their work on overcoming challenges to human subjects research created by the suspension of face-to-face activities during the COVID-19 pandemic. A facilitated reflection and brainstorming session using Miro followed. We used questions to elicit examples of patient and caregiver roles in safety during the pandemic and research strategies and challenges. These questions were also distributed on social media prior to the event. The panel served as an opportunity to share lessons learned.


Author(s):  
David Callaway ◽  
Jeff Runge ◽  
Lucia Mullen ◽  
Lisa Rentz ◽  
Kevin Staley ◽  
...  

Abstract The United States Centers for Disease Control and Prevention and the World Health Organization broadly categorize mass gathering events as high risk for amplification of coronavirus disease 2019 (COVID-19) spread in a community due to the nature of respiratory diseases and the transmission dynamics. However, various measures and modifications can be put in place to limit or reduce the risk of further spread of COVID-19 for the mass gathering. During this pandemic, the Johns Hopkins University Center for Health Security produced a risk assessment and mitigation tool for decision-makers to assess SARS-CoV-2 transmission risks that may arise as organizations and businesses hold mass gatherings or increase business operations: The JHU Operational Toolkit for Businesses Considering Reopening or Expanding Operations in COVID-19 (Toolkit). This article describes the deployment of a data-informed, risk-reduction strategy that protects local communities, preserves local health-care capacity, and supports democratic processes through the safe execution of the Republican National Convention in Charlotte, North Carolina. The successful use of the Toolkit and the lessons learned from this experience are applicable in a wide range of public health settings, including school reopening, expansion of public services, and even resumption of health-care delivery.


PM&R ◽  
2021 ◽  
Vol 13 (6) ◽  
pp. 554-562
Author(s):  
Jonathan H. Whiteson ◽  
Miguel Xavier Escalón ◽  
Susan Maltser ◽  
Monica Verduzco‐Gutierrez

Author(s):  
Tinne Dilles ◽  
Jana Heczkova ◽  
Styliani Tziaferi ◽  
Ann Karin Helgesen ◽  
Vigdis Abrahamsen Grøndahl ◽  
...  

Pharmaceutical care necessitates significant efforts from patients, informal caregivers, the interprofessional team of health care professionals and health care system administrators. Collaboration, mutual respect and agreement amongst all stakeholders regarding responsibilities throughout the complex process of pharmaceutical care is needed before patients can take full advantage of modern medicine. Based on the literature and policy documents, in this position paper, we reflect on opportunities for integrated evidence-based pharmaceutical care to improve care quality and patient outcomes from a nursing perspective. Despite the consensus that interprofessional collaboration is essential, in clinical practice, research, education and policy-making challenges are often not addressed interprofessionally. This paper concludes with specific advises to move towards the implementation of more interprofessional, evidence-based pharmaceutical care.


AAOHN Journal ◽  
1987 ◽  
Vol 35 (10) ◽  
pp. 454-455
Author(s):  
Catherine Yuan ◽  
Jin Yu

Nurses from occupational health care settings around the world, interpreting the theme “Communication, Health Care, and the Community,” presented papers at the First International Conference on Occupational Health Nursing in Edinburgh, Scotland in October, 1986. In keeping with AAOHN's commitment to an international perspective, this article is Part II of a five part series of articles that will be printed in the AAOHN JOURNAL. Next month, Part III of the series will feature, “Occupational Health Nursing World Wide.”


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