MODIFICATION
A -- The Osteoarthritis Initiative – Data Coordinating Center
- Notice Date
- 8/18/2011
- Notice Type
- Modification/Amendment
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except 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-CSB-RDSS-AR-2012-15-KB
- Archive Date
- 9/3/2012
- Point of Contact
- Kelli T Broda, Phone: 301-435-0332, Kristiane E Cooper, Phone: 301-435-6674
- E-Mail Address
-
brodak@mail.nih.gov, cooperke@nhlbi.nih.gov
(brodak@mail.nih.gov, cooperke@nhlbi.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This notice has been amended as follows: This is a sources sought synopsis. This is not a Request for Proposals. The National Heart, Lung, and Blood Institute (NHLBI), on behalf of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is conducting a market survey to assess the availability and technical capability of all qualified sources to perform this requirement. It is anticipated that one award will be made by July 2012 for a period of three years. A small business sources sought announcement is also being issued simultaneously to assess the capability of small businesses to perform this requirement. If two or more small businesses are found capable of performing this requirement, it will be set-aside for small businesses. The National Institute of Arthritis and Musculoskeletal and Skin Diseases is seeking a Data Coordinating Center to complete the follow up years of the Osteoarthritis Initiative (OAI). The OAI is a multi-center, longitudinal, prospective study of knee osteoarthritis (OA) that has developed a public domain research resource. This resource serves to facilitate our basic understanding of OA and as a resource for the development and evaluation of OA biomarkers as potential surrogate endpoints for disease onset and progression. The OAI has recruited and followed for approximately 6 years approximately 4,800 subjects at high risk for OA initiation and progression. The goal of the anticipated Request for Proposal is to complete the creation of the public archive of data, biological samples and joint images collected over an 8 year period from a very well clinically characterized population of individuals who are at high risk of development or progression of osteoarthritis. The completion of this public archive is a critical prerequisite to the evaluation and validation of osteoarthritis biomarkers by the private and public scientific community. The NIAMS requires a Data Coordinating Center to immediately develop, implement, and oversee the following activities at the four OAI Clinical Centers: 1. During the remaining extended follow-up (3 years), the DCC contractor will develop, implement, and oversee the following activities at the four OAI Clinical Centers through existing OAI contracts: A. Mail and telephone contact for entire cohort at 84 months Interviews/questionnaires 1. Assessment of pain and function using WOMAC, KOOS, and other previously used instruments at all visits 2. Monitoring of medication and CAM use 3. Assessment of overall health outcomes 4. Collection of co-morbid conditions 5. Repeat food frequency questionnaire (modified Block) at 84 month visit only 6. Measurement of occupational exposures/activities at 60 and 84 month visits 7. Measurement of development of disability and current levels of disability at 60 month visits only 8. Measurement of anxiety, pain-related fear, coping and catastrophizing at 60 and 84 month visits 9. Assessment of willingness of participants "eligible" for total knee replacement (or other similar procedures) to undergo such surgical procedures, with a focus on racial/ethnic/socio-economic variations at all visits Outcomes adjudications 1. Verification of hospitalizations and surgeries related to knee OA (other than TKR and joint sparing surgeries) reported by all participants at all visits 2. Assessment of participant reliability by interviewer 3. Adjudication of deaths and TJR for hip and knee B. In clinic visits for entire cohort at 72 and 96 months Imaging 1. Core MRI assessments on entire cohort, except those knees with radiographic end stage OA, at 72 and 96 month visits 2. Fixed flexion knee X-rays on entire cohort at 72 and 96 month visits and x-ray of pelvis and dominant hand at 96 month visit 3. DXA for BMD of spine, tibia, and hip and body composition (only at 72) at 72 and 96 month visits Specimen collection 1. Collection of routine size blood samples for archiving at 72 month visit 2. Collection of urine at 72 month visit Interviews/questionnaires 1. Assessment of pain and function using WOMAC, KOOS, and other previously used instruments at all visits 2. Monitoring of medication use at all visits and CAM use at 96 month visit 3. Assessment of overall health outcomes at all visits 4. Collection of co-morbid conditions with adjudication, particularly focused on obesity/cardiovascular/endocrine disorders 5. Measurement of occupational exposures/activities at 96 month visit 6. Measurement of development of disability and current levels of disability at 96 month visit 7. Measurement of anxiety, pain-related fear, coping and catastrophizing at 96 month visit 8. Assessment of willingness of participants "eligible" for total knee replacement (or other similar procedures) to undergo such surgical procedures, with a focus on racial/ethnic/socio-economic variations at all visits Physical measurements 1. Weight annually and height at 96 month visit 2. Abdominal circumference at 96 month visit 3. Performance measures in entire cohort at 72 month visit (20-meter walk and timed chair stands) and in entire cohort 96 months (20-meter walk, 400-meter walk, and timed chair stands) 4. Physical assessment of mobility and disability at 72 months Outcome adjudication 1. Verification of hospitalizations and surgeries related to knee OA (other than TKR and joint sparing surgeries) reported by all participants at all visits 2. Adjudication of co-morbid conditions, particularly focused on obesity/cardiovascular/endocrine disorders at 72 and 96 month visits 2. All data and images to be maintained at OAI online and other media to allow real time access to clinical data and images for analyses. Maintain website in active state with regular updates. 3. Final Contract Closeout: Provide for sufficient, orderly, and safe transition of data systems, documents, and other contract-generated information and materials to the Government or another designated organization authorized by the Government. Specifically, the contractor shall, but is not limited to the following: a. Ensure that x-rays, MRI scans, manuals, databases and directories developed by the contractor are accurate and current, and provision is made for the orderly transfer of these materials to the Federal Government or another designated organization authorized by the Government, together with complete documentation needed to understand their content, operation and maintenance. b. Transfer all contract-developed or government-acquired publications, reprints, abstracts and other documents, results of searches, databases and necessary files to the Federal Government or another designated organization authorized by the Government. c. Transfer all Government purchased or furnished computer hardware, software and other related government equipment, including computer books or documents, and impart the knowledge of its functions to the Federal Government or another designated organization authorized by the Government. Additionally, the DCC will establish (if needed) or maintain the following: 1. Quality assurance for operation of 4 MR scanners at clinical centers 2. Methodologies for receipt of images from Clinical Centers and quality assurance for images received 3. Training and certification of all Clinical Center clinical and imaging staff members 4. Biorepository for storage, archive, and access to biospecimens 5. Laboratory for preparation and storage of and access to DNA 6. Provide travel for PI or Co-PI to attend and present at 2 national or international meetings per year 7. Organize 4 OAI Steering Committee meeting/year: one meeting should be face to face in Chicago, Il NOTE: Needed methodologies may be developed at the Data Coordinating Center or subcontracted to established vendors. Continuity with prior practices is essential whenever possible. Capability Statements will be reviewed based upon the following criteria: 1. Experience and expertise in clinical research in chronic diseases; demonstrated understanding of and experience with clinical and radiographic criteria for the diagnosis of OA; demonstrated expertise with the design, development, and implementation of clinical cohort studies in arthritis or studies of similar complexity; administration and interpretation of outcomes measures; and experience managing clinical studies. 2. Professional, technical, and administrative staff with experience pertinent to the development of a protocol and management of multi-center clinical study of arthritis or studies of similar complexity; demonstrated expertise in assessing outcome measures in arthritis, data collection, data monitoring, quality control, data analysis, and preparation of scientific reports and manuscripts; quality of associated radiology reading center; and experience in analysis and interpretation of medical data for purposes of ensuring subject safety. 3. Suitability of the proposed plan for sample data management, and data analysis and adequacy of the proposed methods of coordination, monitoring, and central management of all activities, and coordination of data collection. Capabilities for storage, on-site and off-site backup and posting of large amounts of clinical and imaging (8-15 terabytes) data. 4. Adequacy of the organizational and administrative structure of the proposed program and institutional commitment to the program; and availability and adequacy of the facilities and resources necessary for conducting study coordination, and data management and analysis, including computer hardware, software, and other equipment in order to successfully implement the requirements of the contract. If an interested organization believes it can perform the above requirement, it may submit a statement of capabilities. The statement of capabilities and any other furnished information must demonstrate the ability to perform the tasks as described above. All responses must be received in writing and must contain material in sufficient detail to allow the NHLBI to determine if the organization is capable of performing this requirement (responses should not exceed 20 pages including attachments). Responses providing insufficient information will not be considered. This is not a Request for Proposals (RFP), nor is an RFP available. Statements of capability must be received at the following address (or by email as a Word document or PDF) no later than 4:00 pm local time, September 2, 2011: National Institutes of Health, National Heart, Lung, and Blood Institute, Office of Acquisitions, Rockledge II - Room 6213, 6701 Rockledge Drive - MSC 7902, Bethesda, MD 20892-7902 (use 20817 for express mail), Attention: Kelli Broda, Contract Specialist, brodak@mail.nih.gov. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted.
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