Christie Eheman, PhD, MSHP Cancer Surveillance Branch Division of Cancer Prevention and Control National Center for Chronic Disease Prevention and
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1 Christie Eheman, PhD, MSHP Cancer Surveillance Branch Division of Cancer Prevention and Control National Center for Chronic Disease Prevention and Health Promotion
2 1992 Cancer Registry Amendment Act, Public Law , authorized CDC to establish NPCR Provided funds to CDC for funding states and territories to enhance or plan/implement registries Work with states to develop model legislation and regulations Provide training on Central Registry operations Standardize a minimum set of data items Set national standards for completeness, timeliness and quality
3
4 48 funded programs 45 states, DC, Puerto Rico, Pacific Islands Jurisdiction NPCR U.S. population coverage - 96% percent In collaboration with NCI 100% population coverage NPCR Cancer Surveillance System Approximately 1.2 million new invasive cancer cases are submitted to CDC electronically each year Data base includes approximately 17.4 million invasive cancer cases from CDC does not receive identifiers (name, address, SSN)
5 Membership organization central cancer registries in U.S. and Canada Supported by CDC, NCI, and other sponsoring organizations as well as membership fees, etc. Sets standards for data items and electronic data record structure Work group structure used to establish standards and include representatives from registries and other partners including CDC
6 Hospitals Outpatient centers Laboratories Radiation therapy centers Electronic Hard copy State Central Cancer Registry Cleaning Editing Analyzing Final data Medical oncology facilities Physicians
7 Record Identification Registry identification Patient ID number Demographic Race Age Sex State County Zip code Census tract Cancer Identification 1 Date of diagnosis Primary site Histology Reporting Source Stage/Progno stic Factors Summary stage Biomarkers (HER2, PR, ER) Followup/Death Date of last contact/death Vital status Cause of death Confidential Patient name Patient address 1 ICD-O codes conversion in data set to manage changes over time
8 Individual NPCR central cancer registries (CCRs) may collect more than is required for their own purposes including research Vital Status Collected from local vital statistics Linkage with National Death Index Encouraged and financially supported by CDC Not all registries have linked Not all registries that have linked have updated their data bases Significant manual review of partial matches
9 Less complete reporting from Physician offices Treatment facilities Out-patient clinics Entire data set ( forward) is resubmitted each year and completeness improves over time Local funding for CCRs has been decreasing Furloughs Hiring freezes Data access for research
10 Data Met Criteria for Inclusion in United States Cancer Statistics State Diagnosis Years State Diagnosis Years AL MT AK NE AZ NV , 2008 AR 2001, NH CA NJ CO NY DE NC DC , ND FL OH GA OK ID OR IL PA IN RI KS SC KY SD LA TN ME TX MD , VT MA VA MI WA MN WV MS WI MO WY
11 State Registry Ref Yr NPCR Ref Yr State Registry Ref Yr NPCR Ref Yr AL MT AK NE AZ NV AR NH CA NJ CO NY DE NC DC ND FL OH GA OK ID OR IL PA IN RI KS SC KY SD LA TN ME TX MD VT MA VA MI WA MN WV MS WI MO WY
12 Percent case completeness estimated based on mortality data Electronic data edits Single field edits for valid code Inter-field edits for consistency Sex, primary site Date of last contact/death, vital status Inter-record edits for consistency among multiple primary sites Verify date of birth same on all records for a patient Verify vital status same on all records for a patient
13 Technical assistance provided by certified tumor registrars from CDC Training Registry software from CDC Data sharing agreements Case sharing across states - strong relationships between states where cancer patients regularly move across states (Florida, New York) Data Audits Central registries CDC
14 Compare data from medical records with central registry data file Also look for missed cases Over last 5 year time period, all registries audited once Central registry self-audits required a small number of cases each year
15 Investigating the Risk of Cancer in US Gulf War Veterans With the Use of State Cancer Registry Data Ann Epidemiol Apr;20(4): e1. Epub 2010 Jan 29 A combined healthy lifestyle score and risk of pancreatic cancer in a large cohort study. Arch Intern Med. 2009;169: Lung Cancer Risk Among Smokers of Menthol Cigarettes J Natl Cancer Inst. 2011;103:1 7 Methodological Issues in United States Retrospective Cancer Incidence Studies Am J Epidemiol. 2009;170:
16 State-Level Mammography Utilization from with Corresponding Breast Cancer Incidence Rates AJR Am J Roentgenol. 2009;192: Utilization of screening mammography in New Hampshire: a population-based assessment Cancer. 2005;104: Characteristics of adult osteosarcoma patients: Results from an ongoing postmarketing drug safety surveillance study Journal of Clinical Oncology, 2010 ASCO Annual Meeting Proceedings (Post-Meeting Edition). Vol 28, No 15_suppl (May 20 Supplement), 2010: 1608
17 Authorizing law requires that CCRs maintain a balance between releasing data for the purposes of cancer control and protecting the patients right of privacy.
18 Currently, laws and regulations regarding CCRs and the release of CCR data are mostly promulgated at the state level - impose additional requirements for review of research and informed consent when human subjects are involved - State statutes often overlap with the federal rules in conducting of human subjects research, but the scope, definitions, and standards of protection vary.
19 Result: One set of procedures for data use and confidentiality cannot be mandated for all locations. Consequence: Accessing CCR data for research, particular for multi-state CCR data is complicated and challenging.
20 Purposes: Gain understanding of comprehensive requirements and barriers of cancer registry data access for research. Identify optimal state/registry rules and policies. Investigate methods for streamlining the IRB processes and pilot test the best methods. Assist researchers in managing the process. Time line: Sept 21, 2010 Sept 20, 2013
21 Finished compilation on - federal and state level policies/regulations/rules for CCR data collection and access - state level IRB application requirements and contacts for access CCR data - state-specific step by step data access application instruction In the process of analysis and loading information into an interactive website. This website has two sites to serve the following purposes: Public site - Provide laws and regulation on cancer registry data collection and access to public and guide researchers step by step to apply and access statespecific CCR data Individual site - Assist researchers to manage multi-state CCR data access and IRB application process
22 Basic required documents from 48 states: Cancer registry data use application Study proposal/protocol List of data items needed Cancer Registry data use/confidentiality agreement In addition to basic requirements, special requirements for data access vary substantially among states
23 State specific Requirements 1. Initial cancer registry contact required prior to application submission 2. Allowance of releasing state residents identifiable data to researchers 3. Requirement of sponsorship from local researcher 4. Requirement of Cancer registry specific Human Subject Protection training Summary 45 states (including DC, US Pacific Islands and Puerto Rico) 48 states allowed after patient s consent 1 state only allows to release it to their own state health department researchers after patient s consent 3 states required local sponsorship 2 states indicated local sponsorship will make application easier 1 state required to be co author for publications 16 states required some type of Human Subject Protection training
24 State specific Requirements 5. IRB approval from requested state and/or researcher s affiliated institution 6. Pediatric research special requirements Summary 16 states required only IRB approval from researcher s affiliated institution 7 states required only IRB approval from registry affiliated institution 23 states required IRB approvals from both researcher s and registry affiliated institution 4 state required IRB approvals from registry affiliated institution but information was not available if IRB approval required from researcher affiliated institution 15 states have special requirements: 4states required parental and/or physician s consent 1 state required special section in application 1 state required cases by case review 1 state does not provide parents contact info 7 states indicated more difficult approval process required 1 states never handled pediatric study requests
25 State specific Requirements Summary Required consent: 26 states required patient consents 21 states required both physician and patients consents 3 state had no standards Consents can be passive or active 7. Patient contact and consent required for releasing of confidential data Who (including DC, US Pacific Islands and Puerto Rico) contacts patients: 16 states - the researcher does the contacting and consenting 15 states - the cancer registry does the contacting and consenting 12 states - the cancer registry does initial contact and researcher consents 4 states - have options on contact and consent
26 State specific Requirements 8. Level of detail and number of steps in the approval process Summary One level: 2 states only required Registry approval 2 states only required IRB approval 1 state only required Cancer Advisory group approval Two levels 14 states required Registry + IRB(s) approval 6 states required Registry + Cancer Advisory group(s ) approval 1 state required Cancer Advisory groups + IRB approval 2 states required State level officer(s) + IRB approval 2 states required Registry + State level officer(s) approval Three levels 13 states required Registry + Cancer Advisory groups + IRB approval 5 states required Registry + state level officer(s) +IRB approval
27 State specific Requirements 9. Frequency of IRB and other regulatory committee meetings 10. Charge of a fee/structure of the fee (IRB fee, data process fee, data linkage fee, etc.) 11. Timeframe for the approval process Summary Weekly: 2 states Monthly: 5 states Quarterly : 5 states Part time: 1 state 33 states will charge fees <2 months: 25 states 3 6 months: 16 states >6 months: 4 states Varied: 5 states (depends on available staff time, seasons, and complexity of case)
28 Christie Eheman The findings and conclusions in this presentation are those of the presenter, and do not necessarily represent the official position of the Centers for Disease Control and Prevention
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