National Cancer Institute Research Agenda

1. National Cancer InstituteResearch Agenda New Opportunities in Health Services and Outcomes Research Steven B. Clauser, Ph.D. Nancy Breen, Ph.D. Applied Research Program http://appliedresearch.cancer.gov/ Academy Health Annual Meeting San Diego June 9, 2004

2. Session Outline • Who We Are and What We Do • New Initiatives in Health Services Research • Improving Quality of Cancer Care • Monitoring Cancer Services: Data and Methods • Funding Opportunities for Junior and Mid-level Investigators

3. Division of Cancer Control and Population Sciences Office of the Director Dr. Robert Croyle, Director Dr. Jon F. Kerner, Deputy Director for Research Dissemination & Diffusion Office OfCancer Survivorship Dr. Julia H. Rowland Epidemiology andGenetics ResearchProgram Dr. Edward Trapido Applied Research Program Dr. Rachel Ballard-Barbash Behavioral Research Program Dr. Scott Leischow, Acting Surveillance Research Program Dr. Brenda K. Edwards Applied CancerScreening Research Dr. Helen Meissner Health Services and Economics Dr. Martin Brown Cancer Statistics Dr. Benjamin Hankey Analytic EpidemiologyResearch Dr. Sandra Melnick Basic BiobehavioralResearch Dr. Michael Stefanek OutcomesResearch Dr. Joseph Lipscomb Statistical Research and Applications Dr. Eric Feuer Clinical and Genetic Epidemiology Research Dr. Deborah M. Winn Health Communicationand Informatics Research Dr. Gary L. Kreps Risk Factor Monitoring and Methods Dr. Susan Krebs-Smith Health PromotionResearch Dr. Linda Nebeling Tobacco ControlResearch Dr. Scott Leischow

4. NCI’s Role in Cancer Research Integrate Discovery Accelerate Interdisciplinary Science Partnerships & Collaborations Development Translational Research Ensure Delivery Application in the Clinic & Public Health Programs

5. Health Services Research is Relevant Across the Cancer Continuum Treatment Diagnosis Survivorship Prevention Detection • End-of-Life Care • Use of Evidence- • Based Therapies • Pain Management • Follow-up of cancer survivors • Risk Assessment (Cancer genetics) • Timely Diagnosis and Referral • Obesity diagnosis and management • Risk Assessment Communication/ • Counseling • Cancer chemo- prevention • Cancer Screening Recommenda-tions and Practices • Cross Cutting Topics • Barriers to Care • Health Disparities • Continuity of Care • Quality of Care

6. *A New NCI Priority to Addressa Major Public Health Concern Improving the Quality of Cancer Care

7. Emerging Consensus from Cancer Research and Policy Communities: • Far too many of the over 9 million cancer patients and survivors in the U.S. do not receive high-quality care. • In many instances, no consensus on what constitutes “quality care” -- especially from the patient’s perspective. • Even where consensus appears to exist, wide variations in practice patterns indicate significant populations disparities in receipt of quality care. • President’s Cancer Panel will focus on “Translating Research into Clinical Practice” in 2004-5 meetings.

8. NCI’s Response….. • Designate “Improving the Quality of Cancer Care” as a priority area in the 2002, 2003, 2004, and 2005 “Bypass Budget”: • The Nation’s Investment in Cancer Research (http://plan.cancer.gov) Goal: Improve the quality of cancer care by strengthening the scientific basis for public and private decision making on care delivery, coverage, purchasing, regulation, and standards setting.

9. Defining “Quality” Cancer Care • Quality of Care is the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge. (Institute of Medicine, 1990) • In the NCI Initiative, this means • provision of evidence-based care across the cancer continuum • in a timely and technically competent manner • with good communication • shared decision making • cultural sensitivity

10. Cancer Care Quality Improvement Cycle Identifying Interventions that Improve Outcomes Strengthening Science Base for Quality of Care Measuring Outcomes that Matter Impacting the Delivery of Care Monitoring Progress and Identifying New Targets

11. Cancer Care Quality Improvement Cycle Identifying Interventions that Improve Outcomes Strengthening Science Base for Quality of Care Measuring Outcomes that Matter Impacting the Delivery of Care Monitoring Progress and Identifying New Targets

12. To Evaluate the State of the Science in Measuring Outcomes that Matter, NCI established the Cancer Outcomes Measurement Working Group • 35 internationally recognized experts, convened in 2001, drawn from academia, government, and industry • Not a consensus panel or advisory committee • Rather, members analyzed literature, interacted, and made recommendations, individually, to NCI • Focused on patient-reported outcomes • Findings forthcoming in Outcomes Assessment in Cancer(Cambridge University Press, 2004)

13. Cancer Outcomes Measurement Working Group Focus on Patient-Reported Outcomes HRQOL Satisfaction/Needs Economic Burden Prevention Screening Treatment Survivorship End of Life Breast Prostate Lung Colorectal

14. Next Steps Post-COMWG • Key Research Gaps • Value-added of patient-reported outcomes (like HRQOL) beyond traditional biomedical endpoints? • Defining the concept of a “clinically meaningful difference” • Successfully negotiating balance between adequate responsiveness for the outcome under study while promoting comparability across studies

15. Cancer Care Quality Improvement Cycle Identifying Interventions that Improve Outcomes Strengthening Science Base for Quality of Care Measuring Outcomes that Matter Impacting the Delivery of Care Monitoring Progress and Identifying New Targets

16. Cancer Care Outcomes Research and Surveillance Consortium:A 5-year, $34M RFA-supported cooperative agreement to: CanCORS • study the impact of targeted interventions on patient-centered outcomes • investigate dissemination of state-of-the-art therapies in the community • examine gaps between best, evidence-based clinical practice and actual care in community • analyze disparities in quality cancer care

17. CanCORS Study Design • Established in 2001 & co-funded by NCI and VA • Large observational cohort study of newly identified lung and colorectal cancer patients • For lung: 5 research teams with N = 4,700 • For colorectal: 6 research teams with N = 5,300 • Socio-economically,geographically, and race/ethnically diverse samples • Public-private provider mix: large HMOs, fee-for-service, VA medical centers

18. CanCORS Study Design (cont) • Rapid case ascertainment : < 3 months after diagnosis • Follow-up patients 12 months after diagnosis • For each patient, creates a longitudinal profile of cancer care by utilization multiple data sources • Investigate structure - process - outcome links at the patient, provider, and organizational level

19. CanCORS Specific Aims • To determine how the characteristics & beliefs of cancer patients and providers and the characteristics of health-care organizations influence treatments and outcomes, spanning continuum of cancer care from diagnosis to recovery or death • To evaluate effects of select processes of care on patients’ survival, health-related quality of life, and satisfaction with care

20. Some CanCORS High-Priority Questions • How and why do processes and outcomes of care vary by patient age, race, ethnicity, SES? • Why do high-volume hospitals tend to have lower surgical mortality rates? • How do patients and physicians go about making treatment decisions for metastatic cancer? • Are symptoms (especially pain and depression) treated effectively?

21. Cancer Care Quality Improvement Cycle Identifying Interventions that Improve Outcomes Strengthening Science Base for Quality of Care Measuring Outcomes that Matter Impacting the Delivery of Care Monitoring Progress and Identifying New Targets

22. The Cancer Care Quality Measures Project (CanQual) • In 2002, NCI spearheaded the creation of a public-private effort: • Convened by the non-profit National Quality Forum (NQF) • Driving Questions: • Where are the most critical quality “gaps”? • How can we measure and close those gaps? • How do we make these measures suitable to support QOC improvement strategies?

23. The Cancer Care Quality Measures Project (CanQual) • Guided by a Steering Committee whose members (voting and liaison) are drawn from across the spectrum of organizations concerned with the quality of cancer care and performance measurement, including: CDC JCAHO NCQA ACoS NCCN ONS ACS AHRQ NQF ASCO ACR AAHP- HIAA OPM NCI CMS NCCS NCPB VA

24. Focus Areas Identified by Steering Committee at Sept 2002 Meeting (Phase I completed) • Tumor-site specific measures: • Breast cancer diagnosis and treatment • Colorectal cancer diagnosis and treatment • Prostate cancer diagnosis and treatment • Cross-cutting measures: • Access to care, including clinical trials • Communications and coordination of care (including IT uses) • Prevention/Screening (including quality of screening, risk assessment, and prevention activities under purview of health systems) • Symptom management and end-of-life care

25. CanQual Project Plan for Phase II (2004-2006) NQF Member Councils & NQF Board Steering Committee (AHRQ, CMS, CDC, NCI as liaison members) Data and Methods Panel 4,5… Technical Panel 1 (e.g., colorectal cancer diagnosis and treatment) Technical Panel 2 (e.g., breast cancer diagnosis and treatment) Technical Panel 3 (e.g., palliative and end-of-life care) Evidence-Based Review Evidence-Based Review Evidence-Based Review

26. Selecting Measures/Research Priorities CanQual Phase II: Timeline Highlights • Contract Start date May 3, 2004 • Steering Committee selects topics July 2004 • Data and Methods Panel selected and convened August2004 • 3 Technical Panels selected and convened Sept. - Oct. 2004 • Technical Panels’ deliver recommendations on core June 2005 - measures and future research priorities to SC Nov. 2005 • Steering Committee deliver recommendations to Sept. 2005 - NQF “Consensus Development Process” Feb. 2006 • NQF 4 Member Councils, membership and Board Sept. 2005 - of Directors review and vote on measures July 2006 • NQF publishes core measures of cancer care Sept. 2006 quality as “voluntary consensus standards”

27. Phase III and Beyond…... • Continue to build the evidence-base for cancer quality of care measurement • Pilot test endorsed QOC measures • Develop new measures with public & private partners • Work with partners to adopt QOC measures and evaluate their dissemination and use • Work with provider and quality improvement organizations to implement QOC-enhancing interventions • Track improvements in QOC -- and feed back findings to policy makers at all levels

28. Cancer Care Quality Improvement Cycle Identifying Interventions that Improve Outcomes Strengthening Science Base for Quality of Care Measuring Outcomes that Matter Impacting the Delivery of Care Monitoring Progress and Identifying New Targets

29. Building a National Cancer Data System * Overall strategy for developing a national system to track quality, access and costs of cancer care services * Data Networks * Data Resources

30. Key Steps Toward Building Capacity • Encourage innovative use of existing data sources • Registries (e.g., SEER, NPCR, NCDB) • Medical records • Administrative files (e.g., Medicare, Medicaid, private payers) • Surveys (e.g., NHIS, CHIS) • Accelerate development and linkage of multiple data sources to • Enhance timeliness, scope, and level of detail in monitoring population • Capture complexity of cancer care to facilitate advanced statistical modeling of structure-process-outcome relationships

31. Health Services Research Networks • National, multi-site research networks that • Can enroll large cohorts of individuals • Track receipt of cancer control services longitudinally at the patient, provider, and health system levels • Investigate impact of interventions on patient-centered outcomes • Current Examples • Breast Cancer Surveillance Consortium (BCSC) • Cancer Care Outcomes Research and Surveillance Consortium (CanCORS) • Cancer Research Network (CRN)

32. Cancer Research Network • Initiated in 1999 to create a population research laboratory in the context of health care delivery systems • Research on cancer prevention, early detection, treatment, and post treatment surveillance • Collaborative cancer research among health care provider organizations oriented to community care • Access to large, stable and diverse populations • Existing integrated data-bases that can provide patient level information

33. Cancer Research Network Sites GHC Ctr for Health Studies - Lead Site HealthPartners Research Foundation Harvard Pilgrim Health Care Henry Ford Health System KPNW Ctr for Health Research KP-Center for Clinical Research KPNC Division of Research Meyers Primary Care Institute KPSC Research & Evaluation KPH Ctr for Health Research, Honolulu * KP = Kaiser Permanente

34. > CRN Population Research Laboratory Data Resources Coordinating CRN Participating Project DETECT Tumor Registry Center: Plan Policy Enrollment Plan Leaders Plans: Meta - data Surveys Providers Hospitalization Plan GHC Surveys Ambulatory visits HIT Study HPHC level Long - term care Plan Leaders HMO Structure HPRF data Providers Diagnostic Imaging HFHS Pharmacy BARRIERS KPH IRB Providers KPNC specific Demographics CRN Project - KPNW Enrollment Administrative KPRM Claims Systems Cancer Registry KPSC Costing Methods Linked on MEYERS Person Health plan - based Death Files Medical Member surveys level Record # Pharmacy Medical data Laboratory Chart Reviews 8.7 million Systems Radiology Population - based covered lives Pathology Hospice (e.g., HEDIS) Hospitalization >3% U.S. Population Home Health Ambulatory Care

35. CRN Projects • Core • Tobacco Cessation – Project HIT(HMOsInvestigating Tobacco) • Breast and Cervical Cancer Screening – Project DETECT (Diagnosing Early Tumors Eases Cancer Treatment) • Outcomes of Prophylactic Mastectomy and Early Screening in High Risk Women – Project PROTECTS(Program Testing Early Cancer Treatment and Screening) • Others CanCORS, IMPACT, Pilot Study of Disenrollment among HMO Patients with Cancer

36. Health Services Research at NCI:Research Resources • National Surveys • National Health Interview Survey – Cancer Control Topical Module, 1987, 1992, 2000 • California Health Interview Survey, 2000 • National Survey of Mammography Facilities, 1992 • National Survey of Colorectal Screening in Healthcare Organizations, 2000 • National Survey of Cancer Genetic Screening, 2000 • Database Resources • SEER – Medicare Linked Database • Cancer Research Network

37. Recent Use of Cancer Screening Tests¹, Initiation of Medicare Coverage², and USPSTF guidelines³: 1987, 1992, 1998, 2000 • PAP smear: • Within the last 3 years, age 25+ • Mammogram: • Within the last 2 years, age 40+ • FOBT: • Fecal Occult Blood Test within the last year, age 50+ • CRE: • Colorectal endoscopy within the last 3 years, age 50+ • PSA: • Prostate Specific Antigen test within the past year, age 50+ USPSTF guidelines Initiation of Medicare coverage Percentages are standardized to the 2000 Projected U.S. Population by 5-year age groups. 1 National Health Interview Survey 2http://healthservices.cancer.gov/seermedicare/considerations/testing.html 3 U.S. Preventive Services Task Force. Guide to clinical preventive services: an assessment of the effectiveness of 169 interventions. Baltimore: Williams & Wilkins, 1989 for mammography and Pap test recommendations. U.S. Preventive Services Task Force. Guide to clinical preventive services, 2nd ed. Washington, DC: Office of Disease Prevention and Health Promotion, U.S. Government Printing Office, 1996 for FOBT and CRE.

38. Latino 11,840 5,147 White 34,383 21,347 Other race 182 290* Asian 3,809 865 African American 2,497 4,492 Two or more races 2,104 33 American Indian/Alaska Natives 424 200 189 * Native Hawaiian & Other Pacific Islander (NHOPI) 55,428 32,374 *Other race in the NHIS includes NHOPI CHIS and National Health Interview Survey (NHIS): Size of Samples CHIS 2001 NHIS 2000

39. Adult Interview Topic Areas (ages 18 and above) Age, gender, race, ethnicity Physical activity Health status Health use and access Health conditions Cancer screening Health insurance Health behaviors Employment Diet Income California Health Interview Survey (CHIS): Designed to Inform Local Health Actions Department of Health Services Public Health Institute California Endowment Sollicited data and health needs from communities, tribes, and health departments NCI CDC IHS

40. Screening Use and follow up Risk Factors Diet & nutrition Vitamin supplements Fruit & vegetable consumption Physical Activity Smoking Family History of Cancer Genetic screening Content of Cancer Module (2000) NHIS CHIS X X X X X X X X X X X X X X X X X

41. What are the SEER - Medicare data? • The SEER-Medicare data are the result of the linkage of two large population-based sources of data: SEER cancer registry data and Medicare claims from CMS • Medicare data are longitudinal, with claims for all covered health services from the time of eligibility to death. Claims come from all types of providers, e.g. hospitals, physicians, outpatient clinics, hospice, etc. • Medicare data are also available for a 5% random sample of persons residing in the SEER areas who have not been diagnosed with cancer. These files can be used to create comparison groups as well as population-based rates of testing and treatment.

42. $$$$$$$$$$$ HSR Funding Opportunities at NCl

43. NCI Funding Mechanisms for Junior and Mid-level Investigators • K-Awards NCI – Training Awards • R03 – Small Research Grants • R21 – Exploratory/Developmental Grants • R01 – Research Projects • http://deainfo.nci.nih.gov/flash/awards.htm

44. Review Process for a Research Grant National Institutes of Health Center for Scientific Review Assign to IC IRG (Study Section) Study Section InitiateResearch Idea Submit Application Review for Scientific Merit Institute Evaluate for Relevance Advisory Councils and Boards Allocate Funds Recommend Action Institute Director Takes Final Action

45. Minority Investigator Career Development Workshophttp://www.scgcorp.com/micdw2004/ • In response to the concern that racial and ethnic minority researchers have been historically underrepresented among NIH funded investigators, the NCI is sponsoring a workshop to provide training to mid-career and/or transitioning investigators from underrepresented racial/ethnic groups to enhance their ability to compete for NIH funding by providing information that will facilitate professional growth and development and increase technical skills. • The workshop will be in Palm Desert, CA July 21-July 23, 2004. • Travel support will be provided to a limited number of participants. Contact: Vickie L. Shavers, PhD email: shaversv@mail.nih.gov

46. Support for Extramural Investigators Who Want to Use the SEER-Medicare Data • NCI offers technical support for data users through: • Extensive SEER-Medicare WEB page http://healthservices.cancer.gov/seermedicare/ • Data users conferences • Medical Care supplement • Special projects related to methods development • There are 2 (PAs) that are support SEER-Medicare projects: • Economic Studies In Cancer Prevention, Screening And Care (PA-02-006) • Cancer Surveillance Using Health Claims-Based Data System (PA-02-005)

47. PAR 04-036: Colorectal Cancer Screening in Primary Care Practice Utilization of CRC screening in the general population is low. CRC screening delivery by primary care physicians is less than optimal. Few U.S. health plans have systems in place for CRC screening recruitment and/or results tracking. Carrie Klabunde, Ph.D. E-mail: ck97b@nih.gov Phone: 301-402-3362 Academy Health Annual Research Meeting, June 2004

48. Types of Studies PAR 04-036 is Intended to Promote • Delivery: • Novel ways of integrating CRC screening into primary care practice. • Risk assessment; time to completion of tests; procedure quality. • Utilization: • Interventions, mechanisms, or systems to improve screening compliance. • Measures, scales, or instruments to assess screening adherence over time and with multiple modalities. • Outcomes: • Test performance characteristics and factors influencing these in community practice. • Adverse events.

49. For further information on anything presented today -- including most appropriate NCI contacts, email…. Steven Clauser Ph.D., Senior Scientist Clausers@mail.nih.gov Nancy Breen Ph.D., Economist Breenn@mail.nih.gov Applied Research Program