The Importance of Conducting PopulationBased Patterns of Care Studies: Improving Cancer Patient Care

1
The Importance of Conducting Population-Based
Patterns of Care Studies Improving Cancer
Patient Care Presentation to the New NPCR
Program Directors Linda Alley, PhD,
RNEpidemiologist, CDC, Division of Cancer
Prevention and ControlMay 2, 2005
2
Overview and Update on NPCRs Two Patterns of
Care (PoC) Studies

• Overarching objectives of the Breast, Colon, and
  Prostate Study (7 NPCR registries) and the
  Ovarian Study (3 NPCR registries) are to
  
• Assess the quality and completeness of cancer
  data collected by registries
  
• Evaluate the extent to which patients are
  receiving stage-specific, guidelines-based cancer
  treatments
  

3
Current and Future Steps Re PoC Studies within
NPCR

• Current PoC studies
• Clean data complete data analyses develop
  manuscripts, reports, presentations
  
• Determine how studies can best inform patient
  care
  
• Use experiences of current studies to help
  develop next CDC-funded PoC study
  
• Build infrastructure/interest across NPCR
  registries to participate in on-going
  CDC-sponsored data quality and treatment PoC
  studies over time
• Complete formal assessment of our PoC website
• Explore PoC study collaborations with others

4
PoC Expected Outcomes and New Directions

• Results of these PoC studies will
• Add significantly to understanding the extent to
  which guidelines-based, stage-specific treatments
  are being used
  
• Help to identify groups of patients (e.g., by
  age, race/ethnicity) who may not be receiving
  adequate cancer treatments.
  
• Long term goals include
• Improving registry data collection
• Developing the infrastructure and capacity within
  NPCR to conduct expanded POC studies
  
• Enhancing the abilities of NPCR registries to use
  registry data to contribute to efforts to improve
  aspects of cancer care to patients.
  

5
Strengths

• Both studies fit nicely within CDCs CCC Program
• Funding mechanism - collaborative agreement
• Increases site ownership of project
• Geographic mix of collaborators
• Frequent communications
• Participants learn from other sites experiences
  
  
• Participants highly responsive/engaged
• Scientific Advisory Group Coding Questions
  Committees solving project issues as a group
  
• Positive Outcomes
• Contributing to literature on PoC using NPCR
  data
  
• Creating model for and infrastructure to conduct
  improved, future CDC PoC studies long-term
  intention to improve registry data
  collection

6
Cancer Data Quality and Treatment Patterns of Ca
re Studies
For more information contact Linda Alley, Ph.D.
(lalley_at_cdc.gov) Sherri Stewart, Ph.D. (sstewart2
_at_cdc.gov) Jen Wike, M.B.A., M.P.H. (jwike_at_cdc.gov
) Bob German, Ph.D. (rgerman_at_cdc.gov) Lyn Almon
, MPH, RD Cancer Surveillance Branch Division of
Cancer Prevention and Control
Centers for Disease Control and Prevention
7
Second Topic Increasing Involvement of Federal
Healthcare Facilities/Registries in NPCR PoC
Studies

• Importance of involvement of registries in
  Federal healthcare facilities in NPCR-funded PoC
  studies
  
• Issues and barriers related to obtaining PoC data
  on patients receiving cancer care in Federal
  facilities
  
• Benefits related to participation of Federal
  heathcare facilities/registries in NPCR
  activities (e.g., PoC studies)

8
CDCs National Program of Cancer Registries (NPCR)

• Goals of the program
• NPCR-funded registries in 45 states, 3
  territories, and the District of Columbia
  
• 96 population coverage
• Uses of cancer registry data
• Ongoing/future NPCR initiatives

9
Some of CDCs multidisciplinary staff involved in
PoC studies
10
Brief Review/Update on CDCs currently funded
Cancer Data Quality and Treatment Patterns of
Care Studies

• Breast, Colon, and Prostate Cancer Data Quality
  and Treatment Patterns of Care Study
  
• Ovarian Cancer Treatment Patterns and Outcomes
  Study
  

11
Breast, Colon, and Prostate Cancer Data Quality
and Treatment Patterns of Care Study

• Collaborative study
• Categorical funding
• 7 participating registries throughout entire
  study
  
• California Cancer Registry
• Colorado Central Cancer Registry
• Illinois State Cancer Registry
• Louisiana Tumor Registry
• New York State Cancer Registry
• Rhode Island Cancer Registry
• South Carolina Central Cancer Registry

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Breast, Colon, and Prostate PoCResearch
Objectives Design Info

• Assess quality/completeness of routinely
  collected stage and treatment data
  
• Determine proportion of patients receiving
  standard of care (NCI Physician Data Query)
  
• Determine tumor, patient, provider
  characteristics associated with different
  treatment patterns
  
• Design info Data were re-abstracted from
  hospital and non-hospital sources for each of the
  sample cases now, the re-abstracted data are
  being compared with existing data in the
  registries for the same cases.

13
Breast, Colon, and Prostate PoC Study Population

• 1997 diagnosis year
• Localized breast
• AJCC stage III colon
• Localized prostate
• 500 CONCORD cases per anatomic site plus simple
  random sample of
  
• 150 localized breast
• 100 AJCC stage III colon
• 100 localized prostate,
• 20 oversampling N per registry2220
• 1st primary of organ (IARC rules)

14
Breast, Colon, and Prostate PoC Data Collected

• Tumor characteristics
• Grade, histology, laterality (breast only), AJCC
  Stage (e.g., tumor size), PSA, Hormone Receptor
  Status (breast only)
  
• Patient characteristics
• Age, race, Hispanic ethnicity, insurance,
  comorbidities, urban-rural, etc.
  
• Provider characteristics
• ACoS accreditation, teaching affiliation, etc.

15
Breast, Colon, and Prostate PoC Time Line

• Oct 2001 Mar 2002 Protocol development
• April Jul 2002 IRB review
• Jul Oct 2002 Training, beta testing
  software, pilot tests
  
• Jan 2003 Began data collection
• Aug 2003 1st interim data submission
• Summer 2004 2nd interim data submission
• Jan and Feb 2005 Final data submissions
• Analysis and publication of results to follow

16
Ovarian Cancer Treatment Patterns and Outcomes

• Collaborative study
• Categorical funding
• Three Participating Registries
• California Cancer Registry
• New York State Cancer Registry
• Maryland Cancer Registry

17
Ovarian PoCResearch Objectives

• Determine first course of treatment received
• Specialty of treating physicians
• Treatment outcomes
• 1- and 3- year survival
• Determine completeness and accuracy of staging
  procedures
  
• Determine what proportion of patients received
  standard of care (1994 NIH Consensus Statement,
  NCI PDQ)

18
Ovarian PoCStudy Population and Design

• First primary invasive ovarian cancer diagnosed
  1998-2000 (in some cases,1997)
  
• Sample size of 1500 cases/registry
• Re-abstraction of charts
• Information collected
• Patient
• Tumor
• Treatment
• Physicians/Facilities

19
Ovarian PoC Time Line

• Nov 2001- Sept 2002 Protocol development
• October 2002 IRB approval received
• Nov 2002 Completion of training manual
• April 2003 Began data collection
• Jan 2004 First interim data submission
• (non-consolidated data)
• Dec-Jan 2005 Final data submission
• Analysis and publication of data to follow

20
Collaborative Process

• Communication
• In-person meetings
• Regularly scheduled conference calls
• Consensus decision-making
• Standardization
• Common protocol
• Common software
• Training manual/train the trainers workshop

21
Challenges

• Collaborative agreement lengthens some aspects
  (e.g., decision-making)
  
• HIPAA Legislation
• Delays hospital chart submission
• Additional explanations from registries
• Decreases willingness to transfer sensitive
  data (e.g., dates)
  
• Using 1997 as the study year for the Breast,
  Prostate, Colon PoC study

22
Challenges (cont)

• Differences across study sites
• Complicates tracking/evaluating relative
  progress, data transfers
  
• Unique staffing and management issues
• Ability to hire CTRs
• Administrative/budget efforts

23
Current Status

• Study sites
• Reviewing data consistency issues identified by
  CDC and submitting corrections working within
  the Scientific Work Group (SAG) to analyze data
  and develop manuscripts and other products
• CDC team
• Coordinating multisite project activities
• Providing scientific leadership
• Cleaning and analyzing aggregate data giving
  presentations on prelim data working within SAG
  as described above
  
• Collaboration
• Data issues and data quality review
• Develop analysis programs, plan reports

24
Future Steps Re PoC Studies at CDC

• Current PoC studies
• Complete data analyses develop manuscripts,
  reports, presentations
  
• Determine how studies can best inform patient
  care
  
• Use experiences of current studies to help
  develop next CDC-funded PoC study
  
• Build infrastructure/interest across NPCR
  registries to participate in on-going
  CDC-sponsored data quality and treatment PoC
  studies over time
• Complete formal assessment of our PoC website
• Explore PoC study collaborations with others

25
Importance of Involvement of Registries in
Federal Healthcare Facilities in NPCR PoC Studies

• 1. Allows detailed information to be examined
  about the quality and completeness of stage and
  treatment data that are routinely collected by
  Federal registries
• 2. Can add significantly to our understanding of
  factors that determine receipt of treatment in
  compliance with established guidelines

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Importance of Involvement of Registries in
Federal Healthcare Facilities in NPCR PoC Studies

• 3. Establishes a baseline of cancer treatment
  patterns in Federal facilities (as well in
  non-Fed facilities) that can be used for future
  comparisons
• 4. Increases the generalizability of findings
  regarding receipt of guidelines-based,
  stage-specific care

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Importance of Involvement of Registries in
Federal Healthcare Facilities in NPCR PoC Studies

• 5. Communication of study results to Federal
  health care professionals could
  
• Illustrate for them the extent to which
  guidelines-based, stage-specific treatments are
  being used
  
• Help to identify groups of patients (e.g., by
  age, race, ethnicity) who are not receiving
  adequate care
  
• Lead to discussions about data quality issues and
  patient care and possible improvements
  

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Importance of Involvement of Registries in
Federal Healthcare Facilities in NPCR PoC Studies

• 6. Provide opportunities for Federal facilities
  participation in the process to identify better
  methods to determine ethnic backgrounds from
  medical records, in order to better assess the
  cancer burden among minority populations in
  future studies.
• 7. Illustrate practical, clinically relevant uses
  of your registry data

29
Issues and Barriers Related to Obtaining PoC Data
on Patients Receiving Cancer Care in Federal
Facilities

• HIPAA and patient confidentiality
• State cancer law components
• Finding a physician champion to serve as a
  liaison between State and Federal systems
  
• Getting cooperation among legal staffswithin the
  State and Federal systems
  
• Both working toward same goal of successful
  reporting without reech of confidentiality
  
• Continued negotiation on the fine details of
  cancer registry operations
  

30
Benefits-Participation of Federal Healthcare
Facilities/Registries in NPCR Activities (e.g.,
PoC Studies)

• Participation in PoC studies could give hospital
  cancer care professionals opportunities to
  
• assess the quality of data collected in their
  registries
  
• Explore the extent to which patients are
  receiving guidelines-based, stage-specific
  treatments for localized breast and prostate
  cancers and stage III colon cancer
• NPCR state registry staff could provide hospital
  registry staff with
  
• Training
• Statistical services to assist with annual report
  preparation
  
• Assistance in conducting a mock ACoS Survey to
  help hospitals prepare for accreditation visits