National Cancer Institute
Research 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
1
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
2
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
Epidemiology and
Genetics Research
Program
Office Of
Cancer Survivorship
Dr. Julia H. Rowland
Behavioral Research
Program
Applied Research
Program
Surveillance Research
Program
Dr. Scott Leischow, Acting
Dr. Rachel Ballard-Barbash
Dr. Brenda K. Edwards
Applied Cancer
Screening Research
Health Services and
Economics
Dr. Helen Meissner
Dr. Martin Brown
Dr. Benjamin Hankey
Basic Biobehavioral
Research
Outcomes
Research
Statistical Research
and Applications
Dr. Michael Stefanek
Dr. Joseph Lipscomb
Dr. Eric Feuer
Health Communication
and
Informatics Research
Risk Factor Monitoring
and Methods
Dr. Edward Trapido
Analytic Epidemiology
Research
Cancer Statistics
Dr. Sandra Melnick
Clinical and Genetic
Epidemiology Research
Dr. Deborah M. Winn
Dr. Gary L. Kreps
Health Promotion
Research
Dr. Linda Nebeling
Tobacco Control
Research
Dr. Scott Leischow
Dr. Susan Krebs-Smith
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
4
Health Services Research is Relevant
Across the Cancer Continuum
Prevention
• Obesity diagnosis
and management
• Risk Assessment
Communication/
Counseling
• Cancer chemoprevention
Detection
Diagnosis
• Risk
• Cancer
Assessment
Screening
Recommenda- (Cancer
genetics)
tions and
• Timely
Practices
Diagnosis
and Referral
Treatment
Survivorship
• End-of-Life • Follow-up of
Care
cancer
survivors
• Use of
EvidenceBased Therapies
• Pain
Management
Cross Cutting Topics
• Barriers to Care
• Health Disparities
• Continuity of Care
• Quality of Care
5
Improving the Quality
of Cancer Care
*
A New NCI Priority to Address
a Major Public Health Concern
6
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.
7
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.
8
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
9
Cancer Care Quality Improvement Cycle
Identifying Interventions that
Improve Outcomes
Measuring
Outcomes
that Matter
Strengthening Science
Base for Quality of Care
Impacting the
Delivery of Care
Monitoring Progress and
Identifying New Targets
10
Cancer Care Quality Improvement Cycle
Identifying Interventions that
Improve Outcomes
Measuring
Outcomes
that Matter
Strengthening Science
Base for Quality of Care
Impacting the
Delivery of Care
Monitoring Progress and
Identifying New Targets
11
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)
12
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
13
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
14
Cancer Care Quality Improvement Cycle
Identifying Interventions that
Improve Outcomes
Measuring
Outcomes
that Matter
Strengthening Science
Base for Quality of Care
Impacting the
Delivery of Care
Monitoring Progress and
Identifying New Targets
15
CanCORS
Cancer Care Outcomes Research and
Surveillance Consortium: A 5-year, $34M
RFA-supported cooperative agreement to:
 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
16
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-forservice, VA medical centers
17
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
18
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
19
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?
20
Cancer Care Quality Improvement Cycle
Identifying Interventions that
Improve Outcomes
Measuring
Outcomes
that Matter
Strengthening Science
Base for Quality of Care
Impacting the
Delivery of Care
Monitoring Progress and
Identifying New Targets
21
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?
22
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
ACS
ONS
AHRQ
NQF
ASCO
ACR
AAHPHIAA
OPM
NCI
CMS
NCCS
NCPB
VA
23
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
24
CanQual Project Plan for Phase II
(2004-2006)
NQF
Data and
Methods
Panel
Steering Committee
(AHRQ, CMS, CDC, NCI as
liaison members)
Member
Councils
& NQF
Board
4,5…
Technical Panel 1
(e.g., colorectal
cancer diagnosis
and treatment)
Evidence-Based
Review
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
25
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
August 2004

3 Technical Panels selected and convened
Sept. - Oct. 2004

Technical Panels’ deliver recommendations on core
measures and future research priorities to SC
June 2005 Nov. 2005

Steering Committee deliver recommendations to
NQF “Consensus Development Process”
Sept. 2005 Feb. 2006

NQF 4 Member Councils, membership and Board
of Directors review and vote on measures
Sept. 2005 July 2006

NQF publishes core measures of cancer care
quality as “voluntary consensus standards”
Sept. 2006
26
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
27
Cancer Care Quality Improvement Cycle
Identifying Interventions that
Improve Outcomes
Measuring
Outcomes
that Matter
Strengthening Science
Base for Quality of Care
Impacting the
Delivery of Care
Monitoring Progress and
Identifying New Targets
28
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
29
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-processoutcome relationships
30
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 patientcentered outcomes
Current Examples



Breast Cancer Surveillance Consortium (BCSC)
Cancer Care Outcomes Research and Surveillance
Consortium (CanCORS)
Cancer Research Network (CRN)
31
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
32
Cancer Research Network Sites
GHC Ctr for Health
Studies - Lead Site
KPNW Ctr
for Health
Research
HealthPartners Research Foundation
Henry Ford
Health System
Harvard Pilgrim
Health Care
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
33
>
Plan
level
data
CRN Population Research Laboratory
CRN
Plan Policy
Surveys
Project
DETECT
Plan Leaders
Providers
HIT Study
Plan Leaders
Providers
Data Resources
Coordinating
Center:
Meta -data
Surveys
BARRIERS
Providers
CRN Project - specific
Cancer Registry
Person
level
data
Health plan -based
Member surveys
Chart Reviews
Population -based
(e.g., HEDIS)
Linked on
Medical
Record #
Tumor Registry
Enrollment
Hospitalization
Ambulatory visits
Long-term care
HMO Structure
Diagnostic Imaging
Pharmacy
IRB
Demographics
Administrative
Enrollment
Systems
Claims
Costing Methods
Death Files
Participating
Plans:
GHC
HPHC
HPRF
HFHS
KPH
KPNC
KPNW
KPRM
KPSC
MEYERS
Pharmacy
Laboratory
8.7 million
Radiology
covered lives
Pathology
Hospice
Hospitalization
>3% U.S.
Home Health
Ambulatory Care
Medical
Systems
Population
CRN Projects


Core
 Tobacco Cessation – Project HIT
(HMOs Investigating 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
35
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
36
Recent Use of Cancer Screening Tests¹, Initiation of Medicare
Coverage², and USPSTF guidelines³: 1987, 1992, 1998, 2000
Women
90
Men
90
 PAP smear:
Within the last 3 years, age 25+
80
80
Within the last 2 years, age 40+
70
60
 FOBT:
60
Fecal Occult Blood Test within
the last year, age 50+
50
 CRE:
40
Colorectal endoscopy within the
last 3 years, age 50+
30
 PSA:
Prostate Specific Antigen test
within the past year, age 50+
20
USPSTF guidelines
10
0
1987 1989 1991 1993 1995 1997 1999
Initiation of Medicare
coverage
Percent
Percent
 Mammogram:
70
50
40
30
20
10
0
1987 1989 1991 1993 1995 1997 1999
Year
Year
Percentages are standardized to the 2000 Projected U.S. Population by 5-year age groups.
1
National Health Interview Survey
http://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.
37
2
CHIS and National Health Interview Survey
(NHIS): Size of Samples
CHIS 2001 NHIS 2000
Latino
White
Other race
Asian
African American
Two or more races
American Indian/Alaska Natives
Native Hawaiian & Other Pacific Islander
(NHOPI)
11,840
34,383
182
3,809
2,497
2,104
424
189
5,147
21,347
290*
865
4,492
33
200
*
55,428
32,374
*Other race in the NHIS includes NHOPI
38
California Health Interview Survey (CHIS):
Designed to Inform Local Health Actions
Adult Interview Topic Areas
(ages 18 and above)
Department
of Health
Services
Public
Health
Institute
California
Endowment
NCI
CDC
IHS
Sollicited data and health needs from
communities, tribes, and health
departments
Age, gender, race, ethnicity
Physical activity
Health status
Health use and access
Health conditions
Cancer screening
Health insurance
Health behaviors
Employment
Diet
Income
39
Content of Cancer Module (2000)
Screening
Use and follow up
Risk Factors
Diet & nutrition
Vitamin supplements
Fruit & vegetable consumption
Physical Activity
Smoking
Family History of Cancer
Genetic screening
NHIS
CHIS
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
40
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.
41
HSR Funding
Opportunities at NCl
$$$$$$$$$$$
42
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
43
Review Process for a Research Grant
National Institutes of Health
Center for Scientific Review
Assign to IC IRG
Initiate
Research Idea
(Study Section)
Study Section
Submit
Application
Review for
Scientific Merit
Institute
Evaluate for
Allocate
Funds
Relevance
Advisory Councils and Boards
Recommend
Action
Institute Director
Takes Final Action
44
Minority Investigator Career
Development Workshop
http://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
45
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)
46
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
Types of Studies PAR 04-036 is
Intended to Promote

Delivery:



Utilization:



Novel ways of integrating CRC screening into primary care
practice.
Risk assessment; time to completion of tests; procedure quality.
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.
48
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
49