Biostatistical Core Funded Grant uri icon

description

  • DESCRIPTION (provided by applicant): The mission of the Yale Older Americans Independence Center (OAIC), established in 1992, is to provide intellectual leadership and innovation for aging research that is directed at enhancing the independence of older persons. The unifying theme of the Yale OAIC remains the investigation of multifactorial geriatric health conditions, encompassing single conditions resulting from multiple contributing factors or affecting multiple outcome domains and multiple conditions occurring simultaneously. The Yale OAIC hypothesis is that geriatric health conditions are determined by the co-occurrence of multiple predisposing and precipitating factors. These conditions and factors, in turn, affect a range of health outcomes. The predisposing factors may be at the genetic, molecular, physiologic, impairment, disease, or socio-demographic level, while the precipitating factors may be behavioral, environmental, social, medical, or psychological. As a related subtheme, the Yale OAIC also aims to advance the science of clinical decision making in the face of tradeoffs and multiple competing outcomes. This includes developing strategies to elicit older persons' health outcome priorities. The Specific Aims of the Yale OAIC are to: 1) foster the career development of future academic leaders, from multiple disciplines, in aging research; 2) train investigators, biostatisticians and other methodologists in the skills necessary to design, conduct, analyze, and disseminate findings from studies of multifactorial geriatric health conditions; 3) develop and disseminate design and analytic techniques for conducting studies of multifactorial geriatric health conditions; 4) develop strategies for recruiting into, and retainin, a broad spectrum of older persons, including minorities, into studies of multifactorial geriatric health conditions; 5) investigate the causative mechanisms of, and develop and test effective treatments for, geriatric health conditions from a multifactorial research perspective; 6) develop strategies to enhance clinical decision making in the setting of multiple health conditions; 7) encourage and facilitate interdisciplinary research (basic, translational and clinical) that connects to our focus on multifactorial geriatric health conditions; and 8) develop and implement strategies that will facilitate the translation of OAIC research into practice and policy. The Yale OAIC cores include: 1) Leadership and Administrative; 2) Research Career Development; 3) Pilot/Exploratory Studies; 4) Operations; 5) Biostatistics; and 6) Information Dissemination. For the first 1 to 2 years of the next cycle, we propose to support 4 RCDC candidates, 3 pilot studies, 2 development projects, and 17 externally funded projects.
  • PROJECT SUMMARY (See Instructions): The primary objective ofthe Biostatistics Core (BC) is to provide state-of-the-art design and analytical services to investigators conducting studies that advance the Yale OAIC theme of multifactorial geriatric health conditions. The two major BC goals are to develop and disseminate new design and analytical techniques for conducting studies with older adults through Development Projects and External Projects (EPs), and to train clinical investigators, biostatisticians, and epidemiologists in the skills necessary to design, conduct, and analyze aging research studies. The goals ofthe BC are achieved under the direction of the Core Leader and Co-Leader who have both worked at the Yale OAIC for the past 10 years and who have served in their current leadership roles since 2006. BC investigators have rich experience in collaborative research, proven expertise in interdisciplinary and translational methods, and stable leadership in planning, administering, and supervising Core activities, providing strong assurance of continued success during the next funding cycle. The Specific Aims ofthe BC are: (1) to collaborate with Pepper Scholars, PESC investigators, the Operations Core, and investigators of EPs to achieve the mission ofthe Yale OAIC in promoting the understanding and treatment of multifactorial geriatric health conditions; (2) to develop new and sound methods that address the challenges of designing and analyzing studies in basic, translational, and clinical geriatric/aging research, with special emphasis on introducing statistical methods from other disciplines; and (3) to train the next generation of statisticians, epidemiologists and junior investigators in Gerontologic Biostatistics research methods specific to studies of multifactorial geriatric health conditions. Administratively, the BC will implement a set of standard operating procedures, assign biostatisticians and related resources to Yale OAIC projects, oversee analytical procedures, communicate with other Cores and EP investigators, and publish statistical results. The distinctive intellectual contributions ofthe BC involve identifying areas where there are gaps in knowledge about the design, conduct, and analysis of studies of multifactorial geriatric health conditions and then developing and applying new methods to address these gaps in knowledge.
  • PROJECT SUMMARY (See instructions): During the last 4 years, the PESC has invested -$650,000 (total costs) in 7 pilot/exploratory studies that have resulted, to date, in 27 publications and ~$17.2 million (total costs) in extramural funding received or expected by July 2012, with an additional ~$7.9 million (5 grants) currently under review. The primary goal of the PESC is to facilitate the development of innovative and rigorous research studies that will enhance our understanding ofthe pathogenesis, etiology, diagnosis, prevention, and management of multifactorial geriatric health conditions (the stated focus ofthe Yale OAIC), leading ultimately to the development of efficacious and cost-effective interventions to increase or maintain the independence of older Americans. The specific aims are to: (1) solicit and select the most meritorious research proposals for PESC funding; (2) provide investigators of Pilot / Exploratory Studies (PESs) with access to resources from the other OAIC Cores; (3) identify potential opportunities for co-sponsorship of PESs; (4) identify potential opportunities for collaboration among PESC investigators; (5) monitor the progress of PESs; (6) provide assistance so that the PESs can be successfully developed into independently funded grant applications; and (7) ensure the safety and protection of human subjects and vertebrate animals enrolled in PESs. Priority for PESC funding will be given to junior investigators as well as to accomplished mid-career and senior investigators who wish to redirect or expand their research to the study of multifactorial geriatric health conditions. In addition to traditional one- or two-year PESs, we propose a new Expedited Pilot Program (EXPI), which will fund small grants capped at a maximum of $5000 that will be awarded within 4 weeks of application. These grants will be limited to junior investigators, up to and including the level of Assistant Professor, and are intended for research activities in which a rapid infusion of a relatively small amount of funds will facilitate a successful extramural grant application. These two PESC grant mechanisms will provide crucial support and access to the research infrastructure provided by the OAIC Operations and Biostatistics Cores, facilitating future external grant support that will advance our understanding of multifactorial geriatric health conditions. In partnership with the OAIC Executive Committee, the key tasks ofthe PESC will be achieved by two highly accomplished physician scientists with complementary areas of expertise: Dr. Albert Shaw (Core Leader), a new NIA K24 recipient, and Dr. Mary Tinetti (Core Co-Leader), former Director of the Yale OAIC, who defined the field of research related to multifactorial geriatric health conditions.
  • PROJECT SUMMARY (See instructions): The overarching aim ofthe Information Dissemination Core (IDC) ofthe Yale OAIC will be to enhance the likelihood that Yale OAIC theme-based research and evidence are translated into practice and policy. Much has been written about the lag between evidence generation and incorporation of results into clinical practice. Even more discouraging are the effective and cost-effective interventions that never get translated into practice. Given the many complex clinical situations facing older adults and their clinicians, this lack of translation is particularly devastating for the growing body of evidence from gerontology and geriatrics that is not being implemented. A priority ofthe OAIC program should be the diffusion and uptake ofthe many interventions proven effective at improving the health and functioning of older adults. Specific aims ofthe Information Dissemination Core are to work with Yale OAIC investigators to: (1) design, conduct, and report research using methods that enhance its dissemination and implementation; (2) develop and implement effective communication techniques for disseminating research results to the lay media, governmental and nongovernmental organizations, and other relevant audiences; (3) enhance knowledge of, and skills in, effective dissemination and implementation strategies; (4) encourage further training in implementation science and techniques; (5) encourage the development and/or adaptation of methods for measuring and evaluating the effectiveness of implementation strategies; and (6) encourage the use of targeted, tailored multi-pronged implementation strategies to enhance the diffusion, uptake, and implementation of OAIC research. The IDC will address these aims through deployment of an innovative combination of practice change strategies and health policy levers, two areas in which the Core Leader, Dr. Mary Tinetti, has extensive expertise and experience. The success of this core will depend on collaboration with several centers and groups at Yale University and other institutions with expertise in information dissemination and implementation science.
  • PROJECT SUMMARY (See instructions): The objective ofthe Research Career Development Core (RCDC) is to identify highly promising early-stage investigators junior faculty) and to provide support promoting their development as independent investigators and leaders in aging research. The RCDC seeks to provide these investigators, designated as "Pepper Scholars", with the knowledge and skills to conduct biological, translational, and clinical studies of multifactorial geriatric health conditions and to obtain subsequent funding from a broad range of sources. The outcomes and career advancement goals for Pepper Scholars include: 1) publication of research results in high-impact journals; 2) success in obtaining independent funding, both to support further career development (e.g. K08 and K23 awards) and to support specific projects (e.g. R21 and R01awards); 3) development of leadership skills necessary to manage research teams and to become successful mentors themselves. The following specific aims are designed to provide the next generation of leaders in aging research: 1) to identify highly promising junior faculty with a strong interest in aging research as Pepper Scholars, with priority given to faculty whose research focuses on multifactorial geriatric health conditions; 2) to promote the development of these Pepper Scholars as independent investigators through the provision of salary, project, infrastructure/technical, and other career development support; 3) to provide Pepper Scholars with priority access to the Resource Cores' expertise and services for the design, conduct, and analysis of studies addressing multifactorial geriatric health conditions; 4) to provide mentorship in aging to Pepper Scholars selected from disciplines outside of geriatrics; 5) to provide oversight of research and career development progress for Pepper Scholars and to provide support for subsequent grant development; 6) to identify a group of junior faculty affiliates who receive more limited support in order to promote their development as potential future Pepper Scholars and to support additional career development and research applications; 7) to provide opportunities for participation in local and national research and career development workshops and seminars with a focus on aging research and in relevant networking and advocacy initiatives; 8) to provide mentorship in implementation science, through the Information Dissemination Core (IDC).
  • PROJECT SUMMARY (See instructions): The overarching objective ofthe Leadership and Administrative Core (LAC) is to advance the field of multifactorial geriatric health condition research. The LAC is responsible for strategic planning, organization, administrative operations and evaluation ofthe OAIC research and training program. A special effort is devoted to ensure the cohesion ofthe Center and maintenance of an interdisciplinary and translational research focus on the common research theme, which is "the investigation of multifactorial geriatric health conditions". The key LAC tasks are achieved by the Core Leader, Co-Leader, Administrator and three committees: the Executive Committee, the Internal Advisory Committee, and the External Advisory Committee. The LAC has gained much experience, knowledge, and understanding of OAIC operations over its 20 years of continuous funding, including the past 10 years under the P30 mechanism. We will build on the existing strong collaborative relationships and expertise as we enter our next funding cycle. The Specific Aims of the LAC are to: (1) oversee the coordination, integration, and administration of all aspects ofthe Yale OAIC, including the utilization of core resources, with other research and training programs at Yale, and foster collaborations that will accomplish the OAIC goals; (2) ensure the conduct of academically productive, innovative, high impact, and clinically safe research by Pepper Scholars, Resource Cores, Pilot/Exploratory Studies (PESs), and External Projects; (3) ensure the independent review and oversight of OAIC research and the training of Pepper Scholars; (4) foster the career development of junior faculty from multiple disciplines into independent investigators and academic leaders in aging research; (5) recruit and encourage outstanding junior and senior faculty to focus their research on aging, particularly multifactorial geriatric health conditions, with an emphasis on translation between basic and clinical research; (6) identify and facilitate productive collaborations with other institutions and OAICs; and (7) monitor university, government and fiscal matters, ensure the preparation of necessary progress reports, and administrative documents relating to the award, and collaborate with the NIA project office and Coordinating Center on OAIC activities. Taken together, the LAC provides support for planning, organizational, evaluation, and administrative activities relating to the other Cores and to the OAIC as a whole. The LAC is responsible for monitoring, stimulating, sustaining, evaluating, and reporting progress toward the overall goals ofthe OAIC.
  • The Yale OAIC is focused on the investigation of multifactorial geriatric health conditions, with the ultimate goal of developing, testing, and disseminating new strategies to preserve or restore the independence of older persons. An Operations Core for the OAIC is essential for the recruitment and retention of diverse populations of older persons into research studies, the building of relationships with community leaders, and the seamless integration of Field personnel tasks with Data Management/Informatics operations. During the past decade, separate Field and Data Management/Informatics (DMI) Coreis existed with a history of major accomplishments. We propose a more efficient structure with the merger of the Field and DMI Cores into a single Operations Core. This streamlined organization, which was endorsed by our External Advisory Committee, optimizes resources, increases efficiency and implementation of clinical and translational research, and facilitates integration of our data collection and data management efforts. The overall goal ofthe Yale OAIC Operations Core (OC) is to provide operational methods, staff, resources, and expertise necessary to ensure the efficient and successful completion ofthe full range of research projects (e.g., observational, interventional, basic/translational) focused on multifactorial geriatric health conditions. As a result, the OC will enhance the scientific productivity of OAIC research and facilitate its overall objectives. Collaborating with all Yale OAIC Cores, the specific aims to achieve its goal include: AIM 1) Provide personnel for recruitment and retention of diverse research participants, and comprehensive data management systems, to support OAIC External Projects. Related Sub Aims include: Sub Aim 1.a. Provide consulting support for operational aspects of proposal preparation; Sub Aim 1 .b. Provide training of investigators and study staff regarding operational tasks; Sub Aim 1 .c. Develop, test, and implement new OC methods. AIM 2) Collaborate with RCDC, PESC, and Biostatistics Cores to facilitate coordinated strategies to develop, implement, and monitor the conduct of Yale OAlC-related studies. AIM 3) Provide support for the design and conduct of a novel OC Development Project, "Adverse Event Monitoring and Reporting among Older Adults Participating in Multifactorial Intervention Trials" This Development Project relates to the integrated objectives ofthe OC and the overall mission ofthe Yale OAIC.

date/time interval

  • 2002 - 2018