SOURCES SOUGHT
A -- Atherosclerosis Risk in Communities (ARIC) Study - Outcomes Research Center
- Notice Date
- 7/29/2009
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- NHLBI-HC-11-09
- Archive Date
- 8/28/2009
- Point of Contact
- Kristiane E Cooper, Phone: 301-435-0345, Elizabeth Zoller, Phone: 301-435-0374
- E-Mail Address
-
cooperke@mail.nih.gov, zollere@mail.nih.gov
(cooperke@mail.nih.gov, zollere@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The National Heart, Lung, and Blood Institute (NHLBI) is conducting a market survey to determine the availability and potential capability of small businesses as defined by NAICS Code 541711 to perform as the Outcomes Research Center (Outcomes RC) as part of the renewal of the Atherosclerosis Risk in Communities (ARIC) study. The ARIC renewal involves a clinical examination (Exam 5) of the cohort that includes repeat and new measures to be performed in May 2011 through April 2013; as well as continued follow-up contact and clinical events surveillance of the cohort through October 31, 2016. The Outcomes RC’s effort is expected to begin on November 1, 2010 and to end October 31, 2016. The ARIC Outcomes RC contractor shall be responsible for various tasks related to the clinical outcomes measures on heart failure and heart failure risk factors to be collected and assessed in the ARIC Exam 5 and during the cohort follow-up. The ARIC study began in 1985, and was designed to monitor the trends in incidence and mortality of coronary heart disease (CHD) in four U.S. communities (Washington County, MD; Forsyth County, NC; Jackson, MS; and Minneapolis, MN) and to investigate the etiology and natural history of subclinical and clinical cardiovascular disease. Accordingly, ARIC includes a community-wide surveillance and a prospective cohort Study. In the community surveillance component, the four communities are investigated to determine the long term trends in hospitalized myocardial infarction (MI) and CHD deaths in approximately 470,000 men and women aged 35-84 years. Events are investigated by review of hospital records and by query of physicians and family members and are given standardized diagnoses. Starting in 2006, surveillance of inpatient (ages 55 years and older) and outpatient heart failure (ages 65 years and older) is included for the events occurring in 2005 and later. In the cohort study, approximately 4,000 individuals aged 45-64 years were recruited by probability sampling from each of the four communities under surveillance. A total of 15,792 participants (11,478 whites, 4,266 African Americans, and 48 other) received an extensive baseline examination in 1987-1989. The examination consisted of questionnaires on sociodemographic characteristics, health behaviors, and psychological factors; anthropometry and physical examination; resting electrocardiography; B-mode carotid ultrasound; a diet history assessment; pulmonary function testing; resting blood pressure; and fasting blood measurements. Three repeat examinations were conducted in 1990-92 (Exam 2), 1993-95 (Exam 3), and 1996-98 (Exam 4), with a response rate of 93%, 86%, and 80%, respectively. Follow-up occurs yearly by telephone to maintain contact with participants and to assess health status of the cohort. Retention rate remains high (92%). There were approximately 13,000 participants alive as of December 2008. In Exam 5 (to be conducted from May 2011 through April 2013), participants will be 67-89 years old, when heart failure and heart failure risk factors become prevalent. The ARIC study offers the opportunity to phenotype heart failure stages using echocardiography and novel biomarkers, and update crucial missing information on heart failure risk factors (e.g., dyslipidemia, hypertension, diabetes, renal insufficiency, and obesity). Through Exam 5, participants with key heart failure risk factors, with asymptomatic or symptomatic heart failure, will be identified. The sub-cohort can then be followed to obtain information about medical care by phone calls (will change from annual to semi-annual) and medical records abstraction, to evaluate patterns of treatment, elucidate factors contributing to those patterns, and assess short and long term outcomes. With well established relationships with the cohort participants and local health care providers, ARIC provides an opportunity to understand how patients with heart failure and heart failure risk factors are clinically managed by health care providers and patients themselves. Knowing how patients at different heart failure stages, especially those at American College of Cardiology (ACC) Stage B, are cared for could help understand current practice patterns in community settings and their associated outcomes, and help generate evidence for “best practices” from which quality improvement measures may be developed. The results from this population-based outcomes research may help translate evidence from epidemiologic studies into clinical practice. The renewal of the ARIC study will address five objectives: 1) re-examine the ARIC cohort to characterize heart failure stages in the community, identify genetic and environmental factors leading to ventricular dysfunction and vascular stiffness, and assess longitudinal changes in pulmonary function and identify determinants of its decline, 2) continue cohort follow-up for cardiovascular events occurring through the year 2014, including CHD, heart failure, stroke, and atrial fibrillation; and for the study of risk factors related to progression of subclinical to clinical CVD, 3) enhance the ARIC cohort study with cardiovascular outcomes research to assess quality and outcomes of medical care for heart failure and heart failure risk factors, 4) continue community surveillance to monitor long-term trends through the year 2014 in hospitalized MI, CHD deaths, and heart failure (inpatient and outpatient); and 5) provide a platform for ancillary studies, training for new investigators, and data sharing. The technical requirements associated with this acquisition for the ARIC Outcomes RC include the following: 1. Work collaboratively with the ARIC Steering Committee to review the information currently collected by the study, identify information gaps and opportunities to enhance ARIC with heart failure outcomes research, and develop research questions related to quality, cost, and outcomes of medical care for heart failure and heart failure risk factors that can be addressed in the ARIC study. 2. Develop the protocol for the collection of information related to quality and outcomes of heart failure and heart failure risk factors (e.g., access to needed care, treatment and care patterns, cost of care, patient satisfaction and compliance, health-related quality of life, survival and mortality) to be included as part of the ARIC Exam 5 and semi-annual follow-up phone calls. 3. Work collaboratively with the ARIC Heart Failure Committee and Steering Committee to develop diagnostic criteria for the Exam 5 and follow-up data to classify ACC heart failure stages and identify participants with key heart failure risk factors, asymptomatic or symptomatic heart failure for the outcomes follow-up. 4. Conduct a pretest of the outcomes research measurement protocol, including quality assurance activities, during the pilot testing phase of the Exam 5, in collaboration with the ARIC Coordinating Center and Field Centers. 5. Work with the Coordinating Center to help train and certify technicians for each Field Center according to the protocol; review quality assurance reports routinely to identify problems and provide feedback to field centers; help with data cleaning for outcomes measures. 6. Perform preliminary data analyses in a timely manner during the pilot phase and throughout the contract period (the approximate numbers of participants anticipated for the pilot test and the Exam 5 are ~ 20 and ~ 9,000, respectively). 7. Identify other data sources (such as Medicare Claims data) to evaluate and compare the cost and quality of care for heart failure and heart failure risk factors at patient, clinician, and system levels; assess influential factors related to the outcomes disparities using ARIC and other data sources; work collaboratively with the Coordinating Center to help with CMS data linkage, analyses, and interpretations. 8. Participate in the ARIC Steering Committee, Heart Failure Committee, Outcomes Research Committee, and Quality Control Committee, as appropriate. 9. Participate actively in data analysis, presentation, and publication using the heart failure outcomes research data. 10. Train young investigators using the ARIC data resource and generate possible ancillary studies on in-depth heart failure outcomes research. 11. Provide technical reports as required by the Government (up to one semiannually and a final). All responsible sources are welcome to submit a written capability statement by August 13, 2009 demonstrating their ability to perform the aforementioned technical requirements. This notice will close fifteen calendar days after posting. The capability statement shall include 1) the professional qualifications of scientific and technical personnel in accordance with the above requirements; 2) demonstrated capacity of individuals and the institutional support to perform the functions of a cardiovascular outcomes research center for a multi-center collaborative epidemiology study, including protocol development, information processing, and coding; 3) facilities and equipment available, including computer equipment and software to analyze data and capability of transferring data between the Heart Failure Outcomes Research Center and the Coordinating Center; 4) evidence of ability to integrate potential advances in cardiovascular outcomes research into study protocol; 5) evidence of the ability to assess and monitor quality control for obtaining and analyzing cardiovascular outcomes research data; 6) evidence of ability to analyze data from longitudinal epidemiologic studies, and publish results in peer reviewed journals; 7) the small business status of the firm. Evaluation of the capability statements shall be based on the first six of the technical points (criteria) above. Each technical point (criterion) shall be weighted equally. Do not include budget information. We ask that the capability statement not exceed 20 single sided or 10 double sided pages in length. Three (3) copies of the capability statement must be received at the following address no later than 15 days from the publication date of this notice. Responses that do not adhere to these guidelines will not be considered. Electronic submissions are also acceptable and may be sent to the following e-mail address: cooperke@mail.nih.gov. This is not a Request for Proposals (RFP) and the Government is not committed to award a contract pursuant to this announcement. If the program is approved for implementation and it is determined to be a small business set aside, then a competitive RFP will be set aside for small business concerns. When released, the RFP will be available on the Federal Business Opportunities website. Questions may be directed to the Contracting Officer, Kristiane Cooper, cooperke@mail.nih.gov, 301-435-0345 or the Contract Specialist, Elizabeth Zoller, zollere@mail.nih.gov, 301-435-0374. Kristiane Cooper, Contracting Officer, Office of Acquisitions, DERA National Heart, Lung, and Blood Institute, NIH, DHHS 6701 Rockledge Drive, Rockledge II, Room 6120, MSC 7902 Bethesda, MD 20892-7902 For overnight deliveries use zip code 20817; no MSC is required.
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