National Cancer Institute
Session Outline
Research Agenda
New Opportunities in Health Services
and Outcomes Research
„
Who We Are and What We Do
„
New Initiatives in Health Services Research
„
„
Steven B. Clauser, Ph.D.
Nancy Breen, Ph.D.
„
Applied Research Program
http://appliedresearch
.cancer.gov
gov//
http://appliedresearch.cancer.
Improving Quality of Cancer Care
Monitoring Cancer Services: Data and Methods
Funding Opportunities for Junior and Mid
- level
Investigators
Academy Health Annual Meeting
San Diego
June 9, 2004
1
2
Division of Cancer Control and Population Sciences
Office
Officeof
ofthe
theDirector
Director
Dr. Robert Croyle, Director
Dr. Robert Croyle, Director
Dr. Jon F. Kerner, Deputy Director
Dr. Jon F. Kerner, Deputy Director
for Research Dissemination & Diffusion
for Research Dissemination & Diffusion
Behavioral
BehavioralResearch
Research
Program
Program
Epidemiology
Epidemiologyand
and
Genetics
GeneticsResearch
Research
Program
Program
NCI’s Role in Cancer Research
Office
OfficeOf
Of
Cancer
CancerSurvivorship
Survivorship
Dr. Julia H. Rowland
Dr. Julia H. Rowland
Applied
AppliedResearch
Research
Program
Program
Dr. Scott Leischow, Acting
Dr. Scott Leischow, Acting
Dr. Rachel Ballard-Barbash
Dr. Rachel Ballard-Barbash
Applied
AppliedCancer
Cancer
Screening
ScreeningResearch
Research
Health
HealthServices
Servicesand
and
Economics
Economics
Surveillance
SurveillanceResearch
Research
Program
Program
Dr. Brenda K. Edwards
Dr. Brenda K. Edwards
Dr. Edward Trapido
Dr. Edward Trapido
Analytic
AnalyticEpidemiology
Epidemiology
Research
Research
Dr. Helen Meissner
Dr. Helen Meissner
Dr. Martin Brown
Dr. Martin Brown
Cancer
CancerStatistics
Statistics
Dr. Benjamin Hankey
Dr. Benjamin Hankey
Dr. Sandra Melnick
Dr. Sandra Melnick
Basic
BasicBiobehavioral
Biobehavioral
Research
Research
Clinical
Clinicaland
andGenetic
Genetic
Epidemiology
EpidemiologyResearch
Research
Outcomes
Outcomes
Research
Research
Dr. Michael Stefanek
Dr. Michael Stefanek
Dr. Joseph Lipscomb
Dr. Joseph Lipscomb
Health
HealthCommunication
Communication
and
and
Informatics
InformaticsResearch
Research
Risk
RiskFactor
FactorMonitoring
Monitoring
and
and Methods
Methods
Statistical
StatisticalResearch
Research
and
and Applications
Applications
Integrate
Discovery
Accelerate
Interdisciplinary Science
Partnerships &
Collaborations
Dr. Eric Feuer
Dr. Eric Feuer
Dr. Deborah M. Winn
Dr. Deborah M. Winn
Dr. Gary L. Kreps
Dr. Gary L. Kreps
Development
Translational Research
Ensure
Dr. Susan Krebs-Smith
Dr. Susan Krebs-Smith
Delivery
Health
HealthPromotion
Promotion
Research
Research
Application in the Clinic &
Public Health Programs
Dr. Linda Nebeling
Dr. Linda Nebeling
Tobacco
TobaccoControl
Control
Research
Research
Dr. Scott Leischow
Dr. Scott Leischow
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
Improving the Quality
of Cancer Care
*
A New NCI Priority to Address
a Major Public Health Concern
Cross Cutting Topics
• Barriers to Care
• Health Disparities
• Continuity of Care
• Quality of Care
5
6
1
Emerging Consensus from Cancer
Research and Policy Communities:
NCI’s Response…..
„
Far too many of the over 9 million cancer patients and
survivors in the U.S. do not receive highhigh-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 20042004-5 meetings.
„
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
http://plan.cancer.gov))
Goal:
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.
7
8
Cancer Care Quality Improvement Cycle
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)
Identifying Interventions that
Improve Outcomes
Measuring
Outcomes
that Matter
In the NCI Initiative, this means
„
„
„
„
„
provision of evidenceevidence-based care across the cancer
continuum
in a timely and technically competent manner
with good communication
shared decision making
cultural sensitivity
Strengthening Science
Base for Quality of Care
Impacting the
Delivery of Care
Monitoring Progress and
Identifying New Targets
9
10
To Evaluate the State of the Science in
Measuring Outcomes that Matter,
NCI established the
Cancer Care Quality Improvement Cycle
Cancer Outcomes Measurement Working Group
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
„
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
2
Cancer Outcomes Measurement Working Group
Focus on PatientPatient-Reported Outcomes
HRQOL
Satisfaction/Needs
Economic Burden
Prevention
Screening
Treatment
Survivorship
End of Life
Next Steps PostPost-COMWG
„
Breast
Prostate
Lung
Colorectal
Key Research Gaps
„
ValueValue-added of patientpatient-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
13
14
Cancer Care Quality Improvement Cycle
CanCORS
Cancer Care Outcomes Research and
Surveillance Consortium: A 55-year, $34M
Identifying Interventions that
Improve Outcomes
RFARFA-supported cooperative agreement to:
„ study
Measuring
Outcomes
that Matter
Strengthening Science
Base for Quality of Care
the impact of targeted interventions on
patient- centered outcomes
Impacting the
Delivery of Care
„ investigate
dissemination of state
- o-f the
- art
therapies in the community
„ examine
gaps between best, evidence
- based
clinical practice and actual care in community
Monitoring Progress and
Identifying New Targets
„ analyze
disparities in quality cancer care
15
16
CanCORS Study Design (cont)
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
„
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
3
CanCORS Specific Aims
Some CanCORS HighHigh-Priority Questions
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
„
„
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?
To evaluate effects of select processes of care
on patients’
- related quality of life,
patients’ survival, health
and satisfaction with care
„
19
20
The Cancer Care Quality Measures
Project (CanQual)
Cancer Care Quality Improvement Cycle
„
Identifying Interventions that
Improve Outcomes
In 2002, NCI spearheaded the creation of a
public- private effort:
„
Measuring
Outcomes
that Matter
Strengthening Science
Base for Quality of Care
„
Impacting the
Delivery of Care
Convened by the nonnon-profit National Quality Forum
(NQF)
Driving Questions:
„
„
„
Monitoring Progress and
Identifying New Targets
Where are the most critical quality “gaps”
gaps”?
How can we measure and close those gaps?
How do we make these measures suitable to support
QOC improvement strategies?
21
22
Focus Areas Identified by Steering
Committee at Sept 2002 Meeting
(Phase I completed)
The Cancer Care Quality Measures
Project (CanQual
(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:
„
Tumor- site specific measures:
„
„
„
CDC
JCAHO
NCQA
ACoS
NCCN
ONS
„
ACS
AHRQ
Cross- cutting measures:
„
„
NQF
ASCO
ACR
„
AAHPHIAA
OPM
NCI
CMS
NCCS
NCPB
Breast cancer diagnosis and treatment
Colorectal cancer diagnosis and treatment
Prostate cancer diagnosis and treatment
VA
„
23
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 endend-ofof-life care
24
4
Selecting Measures/Research Priorities
CanQual Phase II: Timeline Highlights
CanQual Project Plan for Phase II
(2004(2004-2006)
NQF
Member
Councils
& NQF
Steering Committee
Data and
Methods
Panel
(AHRQ, CMS, CDC, NCI as
liaison members)
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)
Evidence-Based
Review
Technical Panel 3
(e.g., palliative and
end-of-life care)
Evidence-Based
Review
„
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 June 2005 measures and future research priorities to SC
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
25
Phase III and Beyond…...
„
Cancer Care Quality Improvement Cycle
Continue to build the evidence
- base for cancer
quality of care measurement
„
„
„
26
Pilot test endorsed QOC measures
Develop new measures with public & private partners
Identifying Interventions that
Improve Outcomes
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
Measuring
Outcomes
that Matter
Strengthening Science
Base for Quality of Care
Impacting the
Delivery of Care
Monitoring Progress and
Identifying New Targets
27
28
Key Steps Toward Building Capacity
Building a National Cancer Data
System
„
Encourage innovative use of existing data
sources
„
„
*
Overall strategy for developing a national
system to track quality, access and costs of
cancer care services
*
Data Networks
*
Data Resources
29
„
„
„
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 structurestructure-processprocessoutcome relationships
30
5
Health Services Research Networks
„
National, multi- site research networks that
„
„
„
„
Cancer Research Network
„
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 patientpatientcentered outcomes
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 datadata-bases that can provide
patient level information
Current Examples
„
„
„
Breast Cancer Surveillance Consortium (BCSC)
Cancer Care Outcomes Research and Surveillance
Consortium (CanCORS
(CanCORS))
Cancer Research Network (CRN)
31
>
Cancer Research Network Sites
GHC Ctr for Health
Studies - Lead Site
KPNW Ctr
for Health
Research
32
CRN Population Research Laboratory
HealthPartners Research Foundation
Henry Ford
Health System
Harvard Pilgrim
Health Care
Plan
level
data
KP-Center for
Clinical Research
KPNC
Division of
Research
CRN
Plan Policy
Surveys
Project DETECT
Plan Leaders
Providers
HIT Study
Plan Leaders
Providers
Data Resources
Coordinating
Center:
Meta -data
Surveys
BARRIERS
Providers
Meyers Primary
Care Institute
CRN Project -specific
KPSC Research
& Evaluation
Administrative
Systems
Cancer Registry
Person
level
data
KPH Ctr for Health Research, Honolulu
Health plan -based
Member surveys
Linked on
Medical
Record #
Chart Reviews
Population -based
(e.g., HEDIS)
* KP = Kaiser Permanente
Tumor Registry
Enrollment
Hospitalization
Ambulatory visits
Long-term care
HMO Structure
Diagnostic Imaging
Pharmacy
IRB
Demographics
Enrollment
Claims
Costing Methods
Death Files
Pharmacy
Laboratory
8.7 million
Radiology
covered lives
Pathology
Hospice
Hospitalization
>3% U.S.
Home Health
Ambulatory Care
Medical
Systems
Population
33
Health Services Research at NCI:
Research Resources
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)
„
National Surveys
„
„
„
„
„
Others CanCORS,
CanCORS, IMPACT, Pilot Study of
Disenrollment among HMO Patients with Cancer 35
Participating
Plans:
GHC
HPHC
HPRF
HFHS
KPH
KPNC
KPNW
KPRM
KPSC
MEYERS
„
„
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
6
Recent Use of Cancer Screening Tests¹, Initiation of Medicare
Coverage², and USPSTF guidelines³: 1987, 1992, 1998, 2000
Women
90
CHIS and National Health Interview Survey
(NHIS): Size of Samples
Men
90
„ PAP smear:
Within the last 3 years, age 25+
80
80
Within the last 2 years, age 40+
70
60
c FOBT:
60
Fecal Occult Blood Test within
the last year, age 50+
50
z 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
CHIS 2001 NHIS 2000
Percent
Percent
‹ Mammogram:
70
50
40
30
20
10
0
1987 1989 1991 1993 1995 1997 1999
Year
Year
Latino
White
Other race
Asian
African American
Two or more races
American Indian/Alaska Natives
Native Hawaiian & Other Pacific Islander
(NHOPI)
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
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
2
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
38
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
39
40
What are the SEER - Medicare data?
„
The SEERSEER-Medicare data are the result of the linkage of
two large populationpopulation-based sources of data: SEER cancer
registry data and Medicare claims from CMS
„
Medicare data are longitudinal,
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 populationpopulation-based rates of
testing and treatment.
HSR Funding
Opportunities at NCl
$$$$$$$$$$$
41
42
7
Review Process for a Research Grant
NCI Funding Mechanisms for
Junior and MidMid-level Investigators
National
National Institutes
Institutes of
of Health
Health
„
„
Center
Center for
for Scientific
Scientific Review
Review
- Awards NCI – Training Awards
K
Assign to IC IRG
Initiate
Research Idea
R03 – Small Research Grants
„
R21 – Exploratory/Developmental Grants
„
R01 – Research Projects
Submit
Application
Review for
Scientific Merit
Institute
Institute
Evaluate for
„
(Study Section)
Study
Study Section
Section
Allocate
Funds
http://deainfo.nci.nih.gov/flash/awards.htm
Relevance
Advisory
Advisory Councils
Councils and
and Boards
Boards
Recommend
Action
Institute
Institute Director
Director
Takes Final Action
43
Minority Investigator Career
Development Workshop
44
Support for Extramural Investigators Who
Want to Use the SEERSEER-Medicare Data
http://www.scgcorp
.com/micdw2004/
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 midmid-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.
„
NCI offers technical support for data users through:
„ Extensive SEERSEER-Medicare WEB page
http://healthservices
.cancer.gov
gov//seermedicare/
http://healthservices.cancer.
seermedicare/
„ Data users conferences
„ Medical Care supplement
„ Special projects related to methods development
„
The workshop will be in Palm Desert, CA July 2121-July
23, 2004.
„
„
Travel support will be provided to a limited number of
participants.
There are 2 (PAs
(PAs)) that are support SEERSEER-Medicare
projects:
„ Economic Studies In Cancer Prevention, Screening
And Care (PA
(PA--0202-006)
006)
„ Cancer Surveillance Using Health ClaimsClaims-Based Data
System (PA
(PA--0202-005)
005)
46
Contact: Vickie L. Shavers, PhD
email: shaversv@mail.
nih..gov
shaversv@mail.nih
45
Types of Studies PAR 0404-036 is
Intended to Promote
PAR 0404-036: 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,
Klabunde, Ph.D.
E-mail: ck97b@nih
ck97b@nih..gov
Phone: 301301-402402-3362
„
„
„
„
„
„
Novel ways of integrating CRC screening into primary care
practice.
Risk assessment; time to completion of tests; procedure
quality.
Utilization:
„
„
Academy Health Annual Research
Meeting, June 2004
Delivery:
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
8
For further information on anything
presented today -- including most
appropriate NCI contacts, email….
Steven Clauser Ph.D., Senior Scientist
Clausers@mail.
nih..gov
Clausers@mail.nih
Nancy Breen Ph.D., Economist
Breenn@mail.
nih..gov
Breenn@mail.nih
Applied Research Program
49
9