Fernald Project

Data and Specimen Sharing

Individuals and groups interested in using the FMMP database and samples for health-related research may apply for Access to Data and/or Frozen Biologic Specimens. If approved by the Fernald Trustee, with the advice of the FMMP Citizen's Advisory Committee, data files from the FMMP database or archived samples (frozen whole blood, serum, plasma and urine) may be distributed to qualified researchers.

Any individual or group desiring access to the FMMP database or archived samples for purposes of analysis must first submit an application to the FMMP Project Director, Dr. Robert Wones, who, in turn, will first obtain input from the Fernald Citizens' Advisory Committee, and then will present the application to the Fernald Trustee with the recommendation of the Fernald Citizens' Advisory Committee and his recommendation. Pdf files of the FMMP Access to Data and Specimens Policy are below.

• FMMP Access to Data and Specimens Policy(Adobe PDF file)



• FMMP Access to Data and Specimens Form(Adobe PDF file)

Findings of Research Studies:

• CANCER INCIDENCE in Participants of the Fernald Medical Monitoring Program (Adobe PDF file)



• Health Effects in Community Residents Near a Uranium Plant at Fernald, Ohio, USA.(Adobe PDF file)



• The Benefits of Community Medical Monitoring at Nuclear Weapons Production Sites: Lessons from Fernald(Adobe PDF file)



• The Medical Heritage Concept: a Model for Assuring Comparable Laboratory Results in Long-term Longitudinal Studies. (Adobe PDF file)



• Do persons living near a uranium processing site have evidence of increased somatic cell gene mutations? A first study.(Adobe PDF file)



• Intercorrelations and sources of variability in three mutagenicity assays: a population-based study.(Adobe PDF file)



• Sources of variability in the human lymphocyte micronucleus assay: a population-based study.(Adobe PDF file)

Continuing Participation is Important for Future Research:

Future research studies (epidemiological studies) will 1) track changes in health status over time and 2) explore the relationship between exposure to materials released from the Fernald Feed Materials Production Center (FMPC) and health effects. To achieve these research objectives, it is important for us to continuously update information on the health status of program participants. We obtain this information by three different means: 1) medical examinations provided by the program; 2)yearly questionnaires mailed to program participants; and 3) when necessary, from outside medical records obtained with permission of the participant. When a participant dies, we record the medical cause of death as noted on the death certificate. We either obtain a copy of the death certificate from the family or access the information through the National Death Index.

A very important function of the yearly questionnaire is to update changes in health status, which occur between examinations. This yearly contact helps us to be better prepared for the next examination. If the participant elects not to have an examination, the information from the yearly questionnaire gives us information on new medical problems, and allows us to follow-up on important diagnoses such as new cases of cancer. The yearly questionnaire also helps us keep current on our contact information for each participant (name, address, phone number and last name changes).

As we become aware of changes in the health status of the program participants, we may request their permission to obtain appropriate medical records (such as biopsy reports, hospital discharge summaries or reports of CT scans). All of the data described above will form the basis for subsequent epidemiological studies as envisioned in the Fernald Settlement Agreement.

Center for Clinical Effectiveness
http://www.healthinstitute.uc.edu/Templates/CentersCCE.cfm

Research and clinical practice activities of the Center bring together staff and Fellows of the Institute as well as investigators from a broad range of disciplines and departments.

The primary focus areas for the Center are:

Health-related Quality of Life Research
The Center is actively engaged in health-related quality of life research both locally and nationally. Recent studies have focused on health status and health values in hospitalized elderly patients and in patients with HIV/AIDS, bipolar disorder, cystic fibrosis, congestive heart failure, osteoporosis, hepatitis C infection and end-stage liver disease. An ongoing NIH-funded 2-city study is focusing on spirituality and health values of patients with HIV/AIDS. VA-funded studies are examining spirituality and the will to live in Veterans with HIV/AIDS, and non-health related mediators of adherence and health values of Veterans with HIV/AIDS.

Cost-effectiveness Analysis / Pharmacoeconomics
The Center conducts cost-effectiveness analyses of diagnostic and treatment strategies for both adults and children. Areas of particular interest are coronary heart disease, management of anticoagulation therapy in heart disease, atrial fibrillation, intracerebral hemorrhage, venous thromboembolic disease and pulmonary embolism, bariatric surgery, prostate cancer, breast cancer, HIV/AIDS, and intensive care. In addition, through collaboration with the College of Pharmacy, Center staff and fellows investigate pharmacoeconomic issues such as the impact of pharmacy-related services and pharmaceuticals on health-related quality of life and other health care outcomes, and studies on the needs of pharmacy benefit managers, pharmaceutical industry product managers, academic health centers, and health care organizations.

Decision Analysis, Patient-Centered Decision Making, and Decision Support Tools
A major strategic goal of the Center is the development of a suite of decision analytically driven decision support tools. These will take a variety of forms, including interactive Web pages and PDA-based tools. The tools will be designed to help either clinicians or patients and their families grapple with complicated therapeutic and diagnostic decisions. One example of such a decision support tool (DST) is an interactive Web page-based DST providing recommendations for anticoagulation therapy for patients with non-valvular atrial fibrillation. In another project that is a prototype of collaborative ventures with the pharmaceutical industry, we are developing a DST to better target the use of drotrecogin alpha (activated) in patients with severe sepsis. NIH-supported work includes developing decision support tools for patients considering bariatric surgery. Our plan is to develop additional DSTs that also may be integrated into the soon to be implemented physician computerized order entry system at The University Hospital.

Geriatrics
Institutional programmatic planning and development continue in pursuit of the development of a Geriatrics Center of Excellence, with research, educational and clinical components. UC recently received a Reynold's Foundation grant, which has assisted in the pursuit of these goals. Current research areas include the impact of screening the elderly for hearing loss and a study of how best to communicate antithrombotic therapy recommendations and results of patient-specific decision analyses to elderly patients with atrial fibrillation, using an interactive, Web-based, computerized decision support tool that incorporates individual patient's utilities for health outcomes and risk factor profiles for ischemic stroke and major bleeding.

Health Disparities
This is a growing area of interest in the Center. Examples of current projects include the examination of racial disparities in the use of inhaled steroid therapy for children with asthma and the impact of these disparities on health outcomes, and racial differences in the prescribing of warfarin for patients with nonvalvular atrial fibrillation in Ohio Medicaid patients. Faculty in our division are collaborating the Departments of Family Medicine and Pediatrics to develop educational initiatives in care of underserved populations, and have received funding from HRSA to develop a program in the care of the underserved.

Sickle Cell Disease
Medicine-Pediatrics faculty in the Division have received HRSA funding to establish a medical home for patients with sickle cell disease who are transitioning from pediatric to adult care. Infrastructure is being developed to coordinate care between the medical home, pediatric and adult sickle cell centers at Cincinnati Childrens's Hospital Medical Center and The University Hospital, and between community primary care sites, and address patients' educational needs about sickle cell disease and its complications.

Severity of Illness
In collaboration with colleagues at the Veterans Affairs Medical Center, Center faculty are involved in studies of severity of illness in intensive care. In addition, the Center assists various health care providers and organizations in Greater Cincinnati as part of a long-range clinical practice improvement program. This program works closely with the Health Research Data Center to conduct research evaluations and related efforts to improve quality, outcomes, and cost-effectiveness in the clinical practice settings of the Health Alliance of Greater Cincinnati and elsewhere.

Outcomes Research
The Center is active in outcomes and effectiveness research in many areas, both locally and nationally. Local projects involve the Veterans Affairs Medical Center and the Children's Hospital Medical Center. In conjunction with the Section of Outcomes Research in the Division of General Internal Medicine, the Center holds a biweekly multi-disciplinary Outcomes Research Conference, which is a seminar for persons interested in conducting outcomes research.

For a list of Outcomes Research Conferences, please go to the following hyperlink:
http://www.healthinstitute.uc.edu/Templates/News.cfm

Quality of Care and Patient Safety
The Cincinnati VA Medical Center is one of only four VA hospitals with a Patient Safety Center. This program is spearheading local and national efforts to improve quality of care and reduce medical errors. In collaboration with colleagues at the Veterans Affairs Medical Center, Center faculty are conducting studies of severity of illness in intensive care. Areas of study include the effect on mortality of restricting patient care privileges to attending physicians with special training in intensive care medicine; a severity of illness model for ICU patients throughout the VA system; outcomes of ventilator-dependent patients transferred from intensive care units to rehabilitation facilities; predictors of warfarin use in a cohort of 11,000 Ohio Medicaid patients with non-valvular atrial fibrillation; psychosocial and clinical predictors of adverse events (bleeding or thrombosis) in Ohio Medicaid patients receiving anticoagulant therapy; the impact of a computerized Atrial Fibrillation Decision Support Tool on clinical outcomes; and the impact of Computerized Physician Order Entry (CPOE) at University and Christ Hospitals on various process measures and the rate of medication errors.

Other Conferences
RIP - The Center holds a weekly research-in-progress meeting (RIP) on Fridays from 2:00 to 4:00 p.m. during which faculty of the Center and collaborators present ongoing work for review and feedback. A didactic lecture series is interspersed through the research presentations.

Decision Modeling Group - In addition, a small group of researchers interested in decision analysis and modeling meet weekly on Wednesdays from 10:00 to 11:00 a.m. collaboratively work on their decision analytic models. This is a hands-on session during which many details and "tricks of the trade" are discussed and demonstrated. ________________________________________

UC Center for Health Informatics
http://www.uc.edu/chi/index.html

CHI faculty are engaged in a wide variety of biomedical informatics research initiatives.
Examples of the research programs and projects underway are listed below.

Clinical Informatics