Note: This announcement has been superceded and is maintained for archival purposes only. For the current announcements, select:
NIH Guide for Grants and Contracts, November 12, 1998
Agency for Health Care Policy and Research
National Cancer
Institute
National Institute of Dental and Craniofacial Research
PA: PA-99-015
Purpose
The Division of Cancer Control and Population Sciences (DCPPS), National
Cancer Institute (NCI); the National Institute of Dental and Craniofacial
Research (NIDCR); and the Agency for Health Care Policy and Research (AHCPR)
invite investigator-initiated grant applications for research to investigate the
utility of health claims information as a reporting source for assessing the
national cancer burden. Health claims include secondary data sources, e.g.,
fee-for-service insurance bills, managed care encounter data, and discharge
summaries. Utility is broadly defined to include topics such as the use of
health claims information to estimate patterns of care, outcomes of care, and
effects of cancer therapies.
Responses to this program announcement (PA) would initiate mechanisms to
expand understanding of the capability of and methods needed to use claims data
for cancer surveillance, as well as applying these findings to the claims data
in order to assess all aspects of cancer surveillance (such as cancer screening,
incidence, treatment, and outcomes). NIDCR's specific interests focus on health
claims-based data as related to oral and pharyngeal cancers or the oral
complications of cancer therapies.
Healthy People 2000
The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000," a
PHS-led national activity for setting priority areas. This PA, "Cancer
Surveillance Using Health Claims-Based Data Systems," is related to the priority
area of cancer surveillance and data systems. Potential applicants may obtain a
print copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or
Summary Report: Stock No. 017-001-00473-1) through the Superintendent of
Documents, Government Printing Office, Washington, DC 20402-9325 (telephone:
202-512-1800).
Eligibility Requirements
Applications may be submitted by foreign and domestic, for-profit and
nonprofit organizations, public and private, such as universities, colleges,
hospitals, laboratories, units of State and local governments, and eligible
agencies of the Federal government. Racial/ethnic minority individuals, women,
and persons with disabilities are encouraged to apply as principal
investigators.
Mechanism of Support
Support of this program will be through the research project grant (R01)
mechanism. Applicants will be responsible for the planning, direction, and
execution of the proposed project. Awards will be administered under PHS grants
policy as stated in the Public Health Service Grants Policy Statement.
Research Objectives
The objectives of this PA are to encourage investigators to submit
applications to investigate the utility of health claims information as a
reporting source for assessing the national cancer burden. Health claims include
secondary data sources such as fee-for-service insurance bills for medical,
dental, rehabilitative, or other health care services, Medicare, Medicaid, and
private managed care encounter data, databases with multiple payers such as the
Healthcare Cost and Utilization
Project (HCUP) database, and discharge summaries. Utility is broadly defined
to include topics such as the use of health claims information to estimate
patterns of care, outcomes of care, and effects of cancer therapies. Examples of
research questions that could be addressed concerning the use of health claims
information for cancer surveillance include, but are not limited to, the
following:
- Can claims data be used to assess practice patterns for cancer directed
treatment immediately following diagnosis and for long-term followup and
treatment over the course of the disease? Using the claims data, what are the
patterns of cancer for persons with specific cancers? What is the pattern for
end-of-life care? What factors influence the care received at end-of-life? How
are treatment patterns and outcomes affected by the use of carve-out contracts
for cancer treatment?
- What is the availability and completeness of encounter data from managed
care settings? Do comparisons of data collected by health claims-based systems
vs. registries differ depending on the reimbursement system (fee-for-service
claims vs. "managed care")?
- Using claims data, what are the long-term complications for cancer
survivors as sequellae to their cancer treatment?
- Can claims data be used to assess the use of diagnostic tests? Using
claims data, how are diagnostic tests used? How can health claims-based data
systems be used to track the emergence of new technologies for detecting,
diagnosing, or treating cancer or pre-cancerous conditions? Can these data be
used to develop an evaluation of the introduction of health care innovations
related to cancer?
- How can health claims-based data systems contribute to the identification
of environmental causes of cancer, such as cluster analysis of incidence in
small areas.
- To what extent do health claims-based data systems provide additional
information than what is routinely collected by cancer registries? Can claims
data be used to assess cancer recurrence or metastasis? Can claims data be
used to augment the case ascertainment of cancer registries?
- Do dental claims data provide useful supplementary data, especially as
regards oral cancer detection or treatments or the prevention and treatment of
oral complications of radiation or chemotherapy? Do health claims-based data
reveal how patterns of cancer-related oral care differ for cancer patients who
have medical health insurance coverage only, as compared with cancer patients
whose health insurance includes supplemental dental benefits?
- Does encounter data in managed care settings permit assessment of whether
the oral health services provided include screening for oral cancers or
services involved in the prevention or treatment of oral complications of
cancer treatments?
Other issues to be addressed in regard to the above questions include: The
identification of data that are currently unavailable from a cancer registry,
such as NCI's Surveillance,
Epidemiology, and End Results (SEER) program, that are available in health
claims-based data systems, the identification of barriers including cost that
must be overcome to add health claims data to registry data, and the
identification of questions concerning health claims data, such as costs
considerations. Use of health claims-based systems to identify cancer burdens in
special populations, such as minority populations (African-Americans, Hispanics,
Native Americans, Native Alaskans, Asian Americans and Pacific Islanders) and
the underserved (low-income groups, blue-collar groups) is encouraged. The use
of claims data to assess population-based cancer incidence and survival rates
has been assessed in numerous earlier studies and is not a priority of this PA.
Also, the confidentiality issues associated with the use of claims-based data,
as well as any other databases proposed, should be addressed in regard to any of
the above questions.
Inclusion of Women and Minorities in Research Involving Human Subjects
It is the policy of NIH and AHCPR that women and members of minority groups
and their subpopulations must be included in all NIH-supported biomedical and
behavioral research projects involving human subjects, unless a clear and
compelling rationale and justification is provided that inclusion is
inappropriate with respect to the health of the subjects or the purpose of the
research. This policy results from the NIH Revitalization Act of 1993 (Section
492B of Public Law 103-43).
All investigators proposing research involving human subjects should read the
"NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical
Research," which have been published in the Federal
Register on March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and
Contracts, Vol. 23, No. 11, on March 18, 1994. AHCPR follows these
guidelines as applicable.
Investigators also may obtain copies of the policy from the program staff
listed under "Inquiries." Program
staff may also provide additional relevant information concerning the
policy.
Policy and Guidelines on the Inclusion of Children as Participants in
Research Involving Human Subjects
It is the policy of NIH and AHCPR that children (i.e., individuals under the
age of 21) must be included in all human subjects research, conducted or
supported by NIH, unless there are clear and compelling scientific and ethical
reasons not to include them. This policy applies to all initial (Type 1)
applications submitted for receipt dates after October 1, 1998.
All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines on the Inclusion of Children as Participants in
Research Involving Human Subjects" that was published in the NIH Guide for
Grants and Contracts on March 6, 1998. It is available at the following URL:
http://www.nih.gov/grants/guide/notice-files/not98-024.html
Application Procedures
Applications are to be submitted on the grant application form PHS 398 and
will be accepted at the standard application deadlines as indicated in the
application kit. The revised PHS 398 form is only available online. Applicants
are encouraged to access the instructions and forms via the Internet because
they provide valuable links to current policy documents and allow easy
navigation of the instructions. PHS 398 application kits cannot be faxed to
applicants.
The title and number of the program announcement must be typed in Section 2
on the face page of the application. Application kits are also available at: http://grants.nih.gov/grants/forms.htm
An applicant planning to submit an application requesting $500,000 or more in
direct costs for any year is advised that he or she must contact Institute or
Center program staff listed in the "Inquiries" section of
this PA before submitting the application. See the NIH policy at: http://www.nih.gov/grants/guide/notice-files/not98-030.html
The completed, original application and five legible copies must be sent or
delivered to:
Center for Scientific Review
National Institutes of Health
6701
Rockledge Drive
Room 1040-MSC 7710
Bethesda, MD 20892*-7710
Phone:
(301) 435-0715
*Change zip code to 20817 for express mail or courier service.
Note: Until further notice, applications delivered by individuals to
the NIH Center for Scientific Review will no longer be accepted. They must come
either via courier delivery or via the U.S. Postal Service. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html.
Review Considerations
Applications will be assigned on the basis of established Public Health
Service referral guidelines. Applications will be reviewed for scientific and
technical merit in accordance with the standard NIH and AHCPR peer review
procedures.
Following scientific-technical review, the applications may receive a
second-level review by the appropriate national advisory council.
Review Criteria
The goals of the supported research are to advance our understanding of
biologic systems, improve the control of disease, improve health care services,
and enhance health. The reviewers will comment on the following aspects of the
application in their written critiques in order to judge the likelihood that the
proposed research will have a substantial impact on the pursuit of these goals.
Each of these criteria will be addressed and considered by the reviewers in
assigning the overall score weighting them as appropriate for each application.
Note that the application does not need to be strong in all categories to be
judged likely to have a major scientific impact and thus deserve a high priority
score. For example, an investigator may propose to carry out important work that
by its nature is not innovative but is essential to move a field forward.
- Significance. Does this study address an important problem? If the
aims of the application are achieved, how will scientific knowledge be
advanced? What will be the effect of these studies on the concepts or methods
that drive this field?
- Approach. Are the conceptual framework, design, methods, and
analyses adequately developed, well-integrated, and appropriate to the aims of
the project? Does the applicant acknowledge potential problem areas and
consider alternative tactics?
- Innovation. Does the project employ novel concepts, approaches or
methods? Are the aims original and innovative? Does the project challenge
existing paradigms or develop new methodologies or technologies?
- Investigator. Is the investigator appropriately trained and well
suited to carry out this work? Is the work proposed appropriate to the
experience level of the principal investigator and other researchers (if any)?
- Environment. Does the scientific environment in which the work will
be done contribute to the probability of success? Do the proposed experiments
take advantage of unique features of the scientific environment or employ
useful collaborative arrangements? Is there evidence of institutional support?
The initial review group will also examine:
- The appropriateness of proposed project budget and duration, the adequacy
of plans to include both genders and minorities and their subgroups as
appropriate for the scientific goals of the research and plans for the
recruitment and retention of subjects.
- The adequacy of plans for including children as appropriate for the
scientific goals of the research (or justification for exclusion).
- The provisions for the protection of human and animal subjects, and the
safety of the research environment.
Award Criteria
Applications will compete for available funds with all other approved
applications assigned. The following will be considered in making funding
decisions: Quality of the proposed project as determined by peer review,
availability of funds, and program priority.
Inquiries
Inquiries are encouraged. The opportunity to clarify any issues or questions
from potential applicants is welcome.
Direct inquiries regarding programmatic issues to:
Joan Warren, Ph.D.
Applied Research Branch
National Cancer
Institute
Executive Plaza North, Room 4005
Bethesda, MD
20892
Telephone: (301) 496-5184
Fax: (301) 435-3710
E-mail:
warrenj@mail.nih.gov
Patricia S. Bryant, Ph.D.
Division of Extramural Research
National
Institute of Dental and Craniofacial Research
45 Center Drive, Room 4AN-24E,
MSC 6402
Bethesda, MD 20892-6402
Telephone: (301) 594-2095
Fax: (301)
480-8318
E-mail: bryantp@de45.nidr.nih.gov
Bernard Friedman, Ph.D.
Agency for Healthcare Research and Quality
540
Gaither Road, Suite 5000
Rockville, MD 20850
Telephone: (301) 427-1404
E-mail: BFriedma@ahrq.gov
Direct inquiries regarding fiscal matters to:
Bill Wells
Grants Administration Branch
National Cancer
Institute
Executive Plaza South, Room 243
Bethesda, MD 20892
Telephone:
(301) 496-8796
Fax: (301) 496-8601
E-mail: wellsw@gab.nci.nih.gov
Christopher Myers
Lead Grants Management Specialist
Grants Management
Branch
National Institute of Dental and Craniofacial Research
Bethesda MD
20892-6402
Telephone: (301) 496-8251
E-mail: cmyers@mail.nih.gov
Mable L. Lam
Grants Management Staff
Agency for Healthcare Research and
Quality
540 Gaither Road, Suite 4000
Rockville, MD 20850
Telephone:
(301) 427-1448
E-mail: MLam@ahrq.gov
Authority and Regulations
This program is described in the Catalog of Federal Domestic
Assistance, No. 93.399, Cancer Control Research, 93.121, Oral Health
Research and 93.226. Awards are made under authorization of the Public Health
Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law
99-158, 42 USC 241 and 285) and administered under PHS grants policies and
Federal Regulations 42 CFR 52 and 67, Subpart A; and 45 CFR Part 74 and part 92.
This program is not subject to the intergovernmental review requirements of
Executive Order 12372 or Health Systems Agency review.
The PHS strongly encourages all grant and contract recipients to provide a
smoke-free workplace and promote the nonuse of all tobacco products. In
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in
certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care, or early childhood
development services are provided to children. This is consistent with the PHS
mission to protect and advance the physical and mental health of the American
people.
AHCPR Publication No. 99-R010
Current as of November
1998
Internet Citation:
Cancer Surveillance Using Health Claims-Based Data System.
Grant announcement. AHCPR Publication No. 99-R015, November 1998. Agency for
Health Care Policy and Research, Rockville, MD.
http://www.ahrq.gov/fund/99015.htm
540 Gaither Road Rockville, MD 20850