SOURCES SOUGHT
A -- Study of Health Outcomes in Autistic Children and Their Families
- Notice Date
- 1/8/2010
- Notice Type
- Sources Sought
- NAICS
- 541720
— Research and Development in the Social Sciences and Humanities
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Mental Health, Contracts Management Branch, 6001 Executive Blvd, Rm 8154, MSC 9661, Bethesda, Maryland, 20892-9661
- ZIP Code
- 20892-9661
- Solicitation Number
- NIH-MH-2010-014
- Point of Contact
- Suzanne Stinson, Phone: 301 443 4116, Bruce E. Anderson, Phone: 301-443-2234
- E-Mail Address
-
sstinson@mail.nih.gov, banderso@mail.nih.gov
(sstinson@mail.nih.gov, banderso@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The National Institute of Mental Health (NIMH) is seeking information on all sources capable of responding to a potential new solicitation entitled "Study of Health Outcomes in Autistic Children and Their Families". The goal of this initiative will be to employ data on one, or more, large representative populations in the United States to describe the health and health care trajectories of individuals with autism and their families. The initial phase of the study will analyze existing data to describe health outcomes and utilization of health care services in this population, both before and after ASD is identified for a given individual or within a given family. It will also gather data that will determine the feasibility of using the database(s) for further exploration of autism risk factors in a subsequent phase of the study. Background The CDC's most recent prevalence data show that one in 110 children have a diagnosis of Autism Spectrum Disorder (ASD). This figure reflects an increase of 57 percent between 2002 and 2006. The CDC states that, although some of the increase is due to better detection, a true increase in risk cannot be ruled out. In any case, ASD clearly poses a significant public health challenge, with substantial research documenting the core social and communication deficits experienced by people with ASD, limited availability of evidence on efficacious and effective treatments, and poor access by patients and their families to existing appropriate treatments. Addressing this public health challenge will require substantial additional information, beyond what is currently available to researchers and policy-makers. ASD is highly heritable, and it is likely that gene-environment interplay has a role in the cause, as well as the expression, of ASD. There have been reports of statistically significant links between a family history of allergic or autoimmune disorders and ASD symptoms, as well as evidence of abnormal immune function in individuals with autism. Environmental exposures of various types have been proposed as potential contributors to ASD risk, including pollutants, pesticides, heavy metals, viruses, and fetal exposure to maternal antibodies or infertility treatments, although no studies have demonstrated a conclusive link. Of course, there is continuing public concern about a potential association between autism and vaccinations, overall or perhaps in a genetically-susceptible subgroup, despite several large-scale epidemiological studies that failed to find a link between autism and vaccinations. More generally, there is limited scientific evidence on the physical health correlates of ASD, particularly at a general population level. In particular, we know relatively little about the range of health trajectories of people with ASD, both before and after the initial presentation and diagnosis of ASD. Similarly, we know little about patterns of health care use over time among people with ASD, before and after ASD is identified. Such information may help identify potential risk factors for ASD and its health correlates that could be a focus for subsequent evaluation, with the ultimate goal of improving outcomes among people with ASD. Moreover, it is likely to be valuable to assess health and health trajectories not just among people with ASD, but also among their (immediate) family members. As a particularly prominent example, health officials in the United States and elsewhere have seen changes in vaccination patterns in the general population, including increasing rates of vaccine refusal, but also vaccination delays and/or separation (e.g., vaccinating at separate times for measles, mumps and rubella, respectively, rather than at once via the "standard" MMR combination). Changing vaccination patterns may have private and public health consequences independent of ASD. Moreover, these changes, and any associated consequences, may be concentrated in families in which one or more people has been identified with ASD, e.g., because of greater behavioral response by parents in such families, and/or if genetic risk for ASD is correlated with risk for immune function abnormalities. Similarly, there are numerous anecdotal reports of elevated rates of gastrointestinal problems and food sensitivities in people with ASD, which might also have a genetic component; in turn, many parents address such issues with biomedical interventions for which there is insufficient data on efficacy or safety. In this context, there is the need for a large-scale study of the health and health care trajectories of children with ASD and their families. A better understanding of the rate of comorbid medical conditions in children with ASD and their families, and medical decision-making within these families, will inform health care service policy and planning. Additionally, health conditions may provide clues to the heterogeneity of the disorder by providing phenotypic subtypes that could be the basis for exploring genetic and environmental risk factors for ASD, including the identification of a subgroup at risk of adverse outcomes from vaccines. The Health Outcomes study will employ data on one, or more, large representative populations in the United States to describe the health and health care trajectories of individuals with autism and their families. The initial phase of the study will analyze existing data to describe health outcomes and utilization of health care services in this population, both before and after ASD is identified for a given individual or within a given family. It will also gather data that will determine the feasibility of using the database(s) for further exploration of autism risk factors in a subsequent phase of the study. Specifically, the Health Outcomes Study will meet the following aims: 1. Describe the medical health trajectories over time of children with ASD and their family members, in relation to timing of the initial identification of ASD. Of interest are rates of infectious diseases, neurological and neurodevelopmental disorders, mood disorders, metabolic dysfunction, genetic disorders, gastrointestinal disorders, nutritional status, sleep disorders, accidents, and stress-related conditions such as hypertension. Trajectories should be compared with demographically similar individuals and households without a family member with ASD. 2. Describe patterns of health care use over time of children with ASD and their family members, including vaccination uptake, rates of vaccination refusal or altered vaccination schedules, psychotropic medication use, and utilization of other services such as conventional and complementary and alternative medicine (CAM) treatments. Patterns should be compared with demographically similar individuals and households without a family member with ASD. 3. Evaluate the feasibility of conducting studies to explore risk factors associated with ASD. Indicators of feasibility include: a. Rates of ASD diagnoses within the available database(s) b. Ability to evaluate the accuracy of ASD diagnoses within the available database(s) relative to established clinical and research criteria c. Ability to identify all family members, including whether they are biologically related d. Determine rates of vaccinated vs. unvaccinated patients in the database(s), and obtain documentation of vaccination status e. Ability to obtain biological specimens f. Ability to accurately assess potential biomedical and environmental risk factors for ASD g. Ability to address loss to follow-up h. Ability and power to detect low-incidence infectious diseases such as measles and pertussis i. Ability to enhance phenotypic characterization of research participants j. Ability to re-contact patients for additional data collection While it is anticipated that a single source will be selected, NIMH anticipates that collaboration between multiple investigators and institutions will be required. The specific experience and capabilities necessary to perform this work include (but are not limited to): 1. Access to, and ability to analyze, large databases to understand rates of disease and accidents, associations among medical conditions, and risk factors for medical conditions 2. Ability to identify a sufficient number of patients with ASD, their families, and appropriately matched controls, to attain statistical power. 3. Ability to estimate the accuracy of ASD diagnoses within the database(s) 4. Ability to identify potential confounders or sources of bias in analyses of risk factors for ASD and propose solutions to these obstacles 5. Clinical and research expertise in Autism Spectrum Disorders 6. Experience collaborating with multiple experts and stakeholders (investigators, clinicians, policy makers, advocates, and consumers) in autism research. Any business or organization that believes it has the capability to fulfill this requirement should submit a brief narrative response (5-10 pages, single-spaced), indicating previous experience and capabilities related to the above work. Capability Statements should clearly state/describe: 1) the offerors experience and qualifications to perform the described work; 2) your type of business or organization, its size (number of employees and gross annual revenue), your eligibility under 8(a) or other set-aside programs, as applicable; and 3) your management structure, history of your organization (e.g., number of years in business and DUNS #); and 4) other resources available to perform this work (e.g. scientific equipment, laboratory facilities, etc.). As a result of this Sources Sought, the NIMH may issue a Request for Proposals (RFP). In the event a RFP will be issued, North American Industry Classification System (NAICS) code 541720 is being considered. However, should such a requirement not materialize, no basis for claims against the NIMH shall arise as a result of a response to this Sources Sought or the NIMH's use of such information as part of our evaluation process. Point of Contact Suzanne Stinson, Contracting Officer, Phone 301-443-4116, Fax 301-443-0501, Email Sstinson@mail.nih.gov PLEASE BE ADVISED THAT NO SOLICITATION IS AVAILABLE AT THIS TIME; THIS NOTICE IS FOR INFORMATION AND PLANNING PURPOSES ONLY. THIS IS NOT A REQUEST FOR PROPOSALS AND DOES NOT COMMIT THE GOVERNMENT TO AWARD A CONTRACT, NOW OR IN THE FUTURE. NO RECEIPT NOTICE WILL BE SENT TO THE SUBMITTER OF A CAPABILITY STATEMENT AND NO EVALUATION WILL BE PROVIDED OF ANY RESPECTIVE CAPABILITY STATEMENT. If the Government decides to issue a solicitation, a Request for Proposal (RFP) will be available solely via the FedBizOpps web page at http://www.fedbizopps.gov/. It will be the offeror's responsibility to monitor the FedBizOpps web page for the release of any solicitation and amendments, and to download all documents. Responses to this notice should be received no later than the stated due date, and can be sent either by mail, fax, or e-mail to Suzanne Stinson, Contracting Officer. If using the U.S. Postal Service or commercial overnight services, please send an original plus five (5) copies of your response. (Note: for commercial overnight services, use Rockville, MD 20852.)
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- SN02038315-W 20100110/100108235331-5fc1d44b1aa948c26bfabbfc1b8aef69 (fbodaily.com)
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