This PA will expire on October 2, 2003, unless reissued. CANCER SURVEILLANCE USING HEALTH CLAIMS-BASED DATA SYSTEM Release Date: October 4, 2001 PA NUMBER: PA-02-006 (see replacement PA-04-012) National Cancer Institute Agency for Health Care Quality and Research This Program Announcement (PA) replaces PA-99-015, which was published in the NIH Guide on November 12, 1998. THIS PA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. MODULAR INSTRUCTIONS MUST BE USED FOR RESEARCH GRANT APPLICATIONS UP TO $250,000 PER YEAR. MODULAR BUDGET INSTRUCTIONS ARE PROVIDED IN SECTION C OF THE PHS 398 (REVISION 5/2001) AVAILABLE AT Since AHRQ study sections require complete budget information in their review, all applications assigned, after initial submission, to AHRQ for review and funding considerations will be requested to submit detailed budget pages prior to the study section review. PURPOSE The Division of Cancer Control and Population Sciences (DCCPS), National Cancer Institute (NCI) and the Agency for Health Care Research and Quality (AHRQ) invite investigator-initiated grant applications for research entailing the use of health claims data for cancer surveillance, including cancer detection, treatment, and outcomes. Health claims include secondary data sources such as the linked SEER-Medicare data, fee-for-service insurance bills for medical, rehabilitative, or other health care services, managed care encounter data, data bases with multiple payers such as the Healthcare Cost and Utilization Project (HCUP) data base and discharge summaries. Studies of cancer treatment may include assessment of patterns of care, quality and outcomes of care across the continuum of treatment and health disparities. Projects funded under this PA may focus on determinants of treatment and outcomes at the patient-specific level or including influences from the provider or broader health-system. In addition to studies of cancer incidence and treatment, responses to this program announcement (PA) may also initiate analyses to expand understanding of the capability of and methods needed to use claims data for cancer surveillance. This Program Announcement (PA) relates to the general health services and outcomes and effectiveness research supported by the AHRQ for a wide range of clinical conditions, including cancer. For example, AHRQ is presently supporting research that supports improvements in health outcomes, strengthens quality measurement and improvement, identifies strategies to improve access, foster appropriate use, and reduce unnecessary expenditures, and promotes advances in health services research methodologies, especially cost-effectiveness analysis. Related research priorities are described in AHRQ Health Services Research Program Announcement PA-00-111, which is available on the WEB at: RESEARCH OBJECTIVES Background There is increasing interest in the collection and analysis of valid, accurate and reliable data related to preventive, screening and treatment intervention related to specific disease entities. For example, the 1998 Institute of Medicine report on Scientific Opportunities and Public Needs: Improving Priority Setting and Public Input at the NIH (See recommends that, "In setting priorities, NIH should strengthen its analysis and use of health data, such as burdens and costs of diseases, and of data on the impact of research on the health of the public." Increasing the use of these types of data to assess the quality of cancer care has also been identified as a priority by the Institute of Medicine ( Studies using claims- based data are usually population-based and have the potential to address a number of priority questions including disparities in health care based on demographic characteristics and the quality of cancer care. Scope of Activity Cancer is a heterogeneous chronic disease characterized by innovation in treatment and care approaches. This initiative supports research directed at the use of health claims data for cancer surveillance, including studies of cancer detection, treatment, and outcomes. In addition, this initiative is directed towards studies that assess the utility of claims data for cancer surveillance. Examples of research topics that could be relevant to the studies of detection, treatment and outcomes include but are not limited to: 1. Studies of the patterns of cancer for persons with specific cancers/stages. This might include treatment during the peri-diagnostic period, use of adjuvant treatments, as well as long-term follow-up. 2. Use of screening tests among the general population and rates of post- diagnostic surveillance for persons with cancer. 3. Differences in cancer screening and treatment based on insurance status- such as uninsured, managed care and fee-for-service, and the impact of carve- out plans. 4. Intensity and types of services provided at the end of life. 5. Rates of short-term complications following cancer treatment. 6. Long-term complications for cancer survivors as sequellae to their cancer treatment. 7. Disparities in the receipt in cancer care based on demographic and socio- economic characteristics. 8. Determinants of the quality of care across the cancer continuum, e.g. training and volume of health care providers. Examples of research topics that could be relevant to assessing the utility of claims data for surveillance include but are not limited to: 1. Use of claims data to assess the frequency and intensity of diagnostic tests. 2. Methods to distinguish screening vs. diagnostic procedures. 3. Methods to identify recurrences or metastases from claims data. 4. Assessment of the availability and completeness of encounter data from managed care settings. 5. Evaluation of the use of health claims-based data systems to identify environmental causes of cancer, such as cluster analysis of incidence in small areas. 6. Determination of whether health claims-based data systems can be used to track the emergence of new technologies for detecting, diagnosing, or treating cancer or pre-cancerous conditions. 7. Use of health claims-based data systems to obtain additional information that is not routinely collected by cancer registries, including enhanced case ascertainment. 8. Methods to measure comorbidity. 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. MECHANISM OF SUPPORT Support of this program will be through the National Institutes of Health (NIH) research project grant (R01) or an exploratory/developmental grant (R21). Applicants will be responsible for planning, direction and execution of the proposed project. Awards will be administered under NIH grants policy as stated in the NIH Grants Policy Statement. The total project period for an application submitted in response to this PA may not exceed 5 years for an R01 application and 2 years for an R21 application. Applicants without extensive preliminary data or who wish to explore the utility of claims-based data to address a specific question are urged to submit applications for this PA using the exploratory/developmental grant mechanism. Investigators are encouraged to seek continued support after completing an exploratory/ developmental grant project through a research project grant (R01). For R21 submissions, applicants may request up to $100,000 direct costs (four budget modules) per year unless the application includes consortium costs, in which case the limit is $125,000 direct costs (five budget modules) per year. Specific application instructions have been modified to reflect "MODULAR GRANT" and JUST-IN-TIME" streamlining efforts being examined by the NIH. Complete and detailed instructions and information on Modular Grant applications can be found at: ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic, for-profit and non-profit 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. 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 313 Bethesda, MD 20892 Telephone: (301) 496-5184 FAX: (301) 435-3710 Email: Bernard Friedman, Ph.D. Agency for Healthcare Research and Quality 2101 East Jefferson Street, Suite 605 Rockville, MD 20852 Telephone: (301) 594-6819 Email: BFriedma@AHCPR.GOV Direct inquiries regarding fiscal matters to: Crystal Wolfrey Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892 Telephone: (301) 496-8634 FAX: (301) 496-8601 Email: Mabel Lam Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 601 Rockville, MD 20852 Telephone: (301) 594-1447 X1165 APPLICATION PROCEDURES The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in- time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and NIH staff. The research grant application form PHS 398 (rev. 5/2001) at is to be used in applying for these grants, with modular budget instructions beginning on page 13 of the application instructions. Applicants are permitted, however, to use the 4/1998 revision of the PHS 398 for scheduled application receipt dates until January 9, 2002. If you are preparing an application using the 4/1998 version, please refer to the step-by-step instructions for Modular Grants available at Although applicants are strongly encouraged to begin using the 5/2001 revision of the PHS 398 as soon as possible, the NIH will continue to accept applications prepared using the 4/1998 revision until January 9, 2002. Beginning January 10, 2002, however, the NIH will return applications that are not submitted on the 5/2001 version. For further assistance contact GrantsInfo, Telephone 301/710-0267, Email: Applicants planning to submit an investigator-initiated new (Type 1), competing continuation (Type 2), competing supplement, or any amended/revised version of the preceding grant application types requesting $500,000 or more in direct costs for any year are advised that he or she must contact the NCI program staff before submitting the application, i.e., as plans for the study are being developed. Furthermore, the application must obtain agreement from the NCI staff that the NCI will accept the application for consideration for award. Finally, the applicant must identify, in a cover letter sent with the application, the staff member and Institute or Center who agreed to accept assignment of the application. This policy requires an applicant to obtain agreement for acceptance of any such application and any such subsequent amendment. Refer to the NIH Guide for Grants and Contracts, March 20, 1998 at SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and NIH staff. The research grant application form PHS 398 (rev. 5/2001) at is to be used in applying for these grants, with modular budget instructions provided in Section C of the application instructions. Applicants are permitted, however, to use the 4/1998 revision of the PHS 398 for scheduled application receipt dates until January 9, 2002. If you are preparing an application using the 4/1998 version, please refer to the step-by-step instructions for Modular Grants available at Additional information about Modular Grants is also available on this site. The title and number of the program announcement must be typed on line 2 of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and five signed photocopies in one package to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) REVIEW CONSIDERATIONS Applications will be assigned based on established NIH referral guidelines. Applications will be evaluated for scientific and technical merit by an appropriate scientific review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. Review Criteria The five criteria to be used in the evaluation of grant applications are listed below. The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, 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. 1. 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? 2. 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? 3. Innovation. Does the project employ novel concepts, approaches, or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? 4. 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)? 5. 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: o the appropriateness of proposed project budget and duration, o the adequacy of plans to include both genders, minorities (and their subgroups), and children as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects, o the provisions for the protection of human and animal subjects, o the safety of the research environment, o the adequacy of the proposed plan to share data. AWARD CRITERIA Award criteria that will be used to make award decisions include: o scientific merit (as determined by peer review) o availability of funds o programmatic priorities. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their sub- populations 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 indicating 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 UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (, a complete copy of the updated Guidelines is available at The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups, if applicable, and b) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS. It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the 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, March 6, 1998, and is available at the following URL address: 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. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS All investigators proposing research involving human subjects should read the NIH policy on education in the protection of human research participants now required for all investigators, which is published in the NIH Guide for Grants and Contracts, June 5, 2000 (Revised August 25, 2000), available at the following URL address: A continuing education program in the protection of human participants in research is now available online at PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. URLS IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. REQUIREMENTS FOR SHARING RESEARCH RESOURCES NIH policy requires that investigators make unique research resources readily available for research purposes to qualified individuals within the scientific community when they have been published. All investigators should read the Guidelines available at the following url address: See also: NIH Grants Policy Statement ( and Sharing Biomedical Research Resources: Principles and Guidelines for Recipients of NIH Research Grants and Contracts: Final Notice, December 1999 ( It is expected that biomaterials and other patentable research resources (examples could be, but are not limited to, vectors, embryonic cell lines, mutant mice, etc.) produced in projects funded by this initiative will be made available and distributed to the broader scientific community. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS led national activity for setting priority areas. This PA, Cancer Surveillance Using Health Claims-Based Data System, is related to priority area of cancer control. Potential applicants may obtain a copy of "Healthy People 2010" at 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 recipients to provide a smoke-free workplace and promote the non-use 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.

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