What Is a Cancer Registry? - University of Massachusetts Boston

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Cancer Registries and Medical Records
Rich Data Resources
Carol Lowenstein, MBA, CTR
Assistant Director
Survey and Data Management Core
Dana-Farber Cancer Institute
Co-Coordinator, Survey & Statistical Methods Core
Objectives
• Describe cancer registries
• Review the history of cancer registries – why we collect data
• Review the types of registries and data available
• Understand the varied uses of registry data – where to go, what to
use, and the limitations
• Explore the value added through linkages of registry data with other
data sources
• Discuss medical record review vs. cancer registry data
• Describe medical record review
What Is a Cancer Registry?
•
Information system designed to:
– Collect
– Manage
– Analyze
data on persons with the diagnosis of a malignant or neoplastic disease
(cancer).
•
Cancer registries can be classified into three general types:
– Hospital based registries: maintain data on all patients diagnosed
and/or treated for cancer at their facility and report cancer cases to the
central or state cancer registry as required by law.
– Population-based central registries: maintain data on all cancer
patients within certain geographical areas.
– Special purpose registries: maintain data on a particular type of
cancer, such as brain tumors.
Source: National Cancer Registrars Association
What Is a Cancer Registry?
• Registry data is:
– Used to make public health decisions
– A valuable research tool for those interested
in the etiology, diagnosis and treatment of
cancer
– Used in fundamental research on the
epidemiology of cancer
Source: National Cancer Registrars Association
What Is a Cancer Registry?
•
Information maintained in a cancer registry:
– Demographic Information: Age, gender, race/ethnicity, birthplace and
residence.
– Medical History: Physical findings, screening information, occupation
and any
history of a previous cancer.
– Diagnostic Findings: Types, dates and results of procedures used to
diagnose cancer.
– Cancer information: Primary site, cell type and extent of disease.
– Cancer Therapy: Surgery, radiation therapy, chemotherapy, hormone
or immunotherapy.
– Follow-up: Annual information concerning treatment, recurrence, and
patient status is updated to maintain accurate surveillance information.
Source: National Cancer Registrars Association
What Is a Cancer Registry?
How are these data used?
• Evaluate patient outcome, quality of life, and satisfaction issues and
implement procedures for improvement
• Provide follow-up information for cancer surveillance
• Calculate survival rates by various data items
• Provide information for cancer program activities
• Analyze referral patterns
• Allocate resources at the health care facility, the community, region
or state level
• Develop educational programs for health care providers, patients
and the general public
• Report cancer incidence as required under state law
• Evaluate efficacy of treatment modalities
Source: National Cancer Registrars Association
History of Cancer Registries
Key Events
2500 B.C.
• Earliest known description of "cancer": the "Edwin Smith" and "George
Ebers" papyri which describe surgery, pharmacology, and mechanical and
magical treatments
400 B.C.
• Hippocrates described a breast "cancer" as "karkinoma" (known now as
carcinoma) during surgical removal of a tumor
1629 A.D.
• Cancer is first mentioned as a cause of death in the Bills of Mortality in
England
1728
• London's "General Census of Cancer" - the first known systematic collection
of information on cancer is generated
Source: NCI SEER Program
History of Cancer Registries
Key Events
1839
• Implementation of death registration (what we now know as "death
certification") in the United States
1901
• Earliest known population-based systematic collection of data on people
with leprosy in Norway (a population-based leprosy registry)
1926
• A bone sarcoma registry established by Dr. Ernest Codman at
Massachusetts General Hospital, one of the earliest registries established
for a specific type of cancer
•
The first hospital-based cancer registry at Yale-New Haven Hospital was
organized in New Haven, Connecticut
Source: NCI SEER Program
History of Cancer Registries
Key Events
Ernest Amory Codman, M.D
• Kept track of his patients with End Results Cards
• Tracked the outcomes of patient treatments
• Identified areas of improvement in patient care
• Believed that this information should be made public
and that this, not seniority, be the basis for
physician promotion
• Help found the American College of Surgeons and
the Joint Commission on Accreditation of
Healthcare Organizations
Source: Countway Medical Library
History of Cancer Registries
Key Events
1935
• First population-based cancer registry in the United States established in
Connecticut
1956
• The American College of Surgeons requires a cancer registry as a
component of an approved cancer program
1971
• The U.S. National Cancer Act budgets monies to the National Cancer
Institute for research, detection, and treatment of cancer
1973
• The Surveillance, Epidemiology and End Results (SEER) Program of NCI
establishes the first national cancer registry program
Source: NCI SEER Program
History of Cancer Registries
Key Events
1992
• U.S. Public Law 102-515 establishes the National Program of Cancer
Registries (NPCR) and is administered by the US Centers for Disease
Control and Prevention (CDC)
1993
• Many state laws make cancer a reportable disease
Source: NCI SEER Program
History of Cancer Registries
Cancer Registration
• Late 16th Century
Prompted by the seemingly random geographic ravages of the
plague, the English Crown appointed elderly, epidemic-scarred
women to prowl the countryside in search of the dead and dying.
These 'Ancient Matrons' published weekly 'Bills of Mortality' for
each parish, tabulating deaths by causes such as 'the purples'
(probably leukemia), 'riting of the lights', 'consumption' (often an
effect of cancer), and of course, the plague. Just how this
information was used is not recorded. Perhaps the royalty found it
helpful to determine where the plague was active so they could be
somewhere else
Source: NCI SEER Program
History of Cancer Registries
Cancer Registration
• Mid 17th Century
Around 1665 a London businessman, John Graunt, created medical
history by subjecting decades of mortality data to critical and
mathematical analysis. He literally invented the science of medical
epidemiology and statistics, publishing a pamphlet with 108
conclusions. The list included such revolutionary observations as
the facts that women saw physicians twice as often as men yet lived
longer, and plague epidemics moved outward from swampy areas.
Graunt also was the first person to use mortality statistics to project
population survival, probably by crudely fitting data samples to a
logarithmic curve.
Source: NCI SEER Program
History of Cancer Registries
Cancer Registration
•Early 1900’s
–Bone sarcoma registry at MGH
–Yale-New Haven Hospital Cancer Registry
–Other hospitals began to develop registries as
physicians saw the benefits of comprehensive data
collection
–Connecticut population-based cancer registry
History of Cancer Registries
Cancer Registration
• 1937-39
– First National Cancer Survey
•
•
•
•
•
•
•
•
Initiative of the newly formed NCI
Directed by Harold F. Dorn
Included only MD dx’d cases, histolgic confirmation
3 regions of the US – north, south, west
10 registries in metropolitan areas, MD abstractors
Included 10% of the overall population,
Resulted in several papers
Sparked questions about genetic factors,
racial, gender and economic disparities
Harold F. Dorn
Source: Lilienfeld, Am J Public Health, Dec 2008
History of Cancer Registries
Cancer Registration
• 1947-48
– Second National Cancer Survey
• 1956
– American College of Surgeons Commission on
Cancer (CoC) requires hospital cancer registries for
Commission approved cancer programs
• 1967-71
– Third National Cancer Survey
History of Cancer Registries
Cancer Registration
• 1973
– SEER Registry
• 1992
– NPCR funding for state cancer registries
History of Cancer Registries
Cancer Registration
• What were they trying to achieve?
– A standard classification of disease
– A systematic form of data collection
– Analysis and use of the data
Sources of Cancer Registry Data
• Levels of registries
–Hospital
–Central
–National
–International
Sources of Cancer Registry Data
• Data collected using ICD-O
– Based on ICD-9 codes
– Separate codes for site (T – topography
codes) and histology (M – morphology codes)
– Coding manual
• Topography numerical
• Morphology numerical
• Alphabetic index
Sources of Cancer Registry Data
• Reliance on data standards
– Each data item collected has a very specific
set of rules
• Edits
– Developed by national organizations
– Applied at hospital and central levels
Sources of Cancer Registry Data
• Hospital Cancer Registries
• Massachusetts Cancer Registry (MCR)
• North American Association of Central Cancer
Registries (NAACCR)
• Surveillance Epidemiology and End Results
(SEER)
• International Agency for Research o Cancer
(IARC)
Hospital Cancer Registries
• Cancer Reporting Law in MA
• Variability in Size
• Collect a large data set established by national
organizations
• Sophisticated edits process
Hospital Cancer Registries
• Demographic Data
- Address, age, gender, race, ethnicity, insurance, census
tract, birthplace, occ/ind, tobacco/alcohol hx, family hx
• Tumor Data
- Primary site, histology, grade, stage, laterality
• Treatment Data
- Surgery, chemo, XRT, hormone, BRM
• Vital Status- Follow up Data
• Report to the state/central registry
• Within 6 months to 1 year after diagnosis
– capture first course of treatment
Hospital Cancer Registries
• Quality of data
– Varies
•
•
•
•
ACoS vs non-ACoS approved programs
Size of hospital
Teaching/research vs. community hospital
Involvement and interest of MD’s and administration
– Standardized data collection software
– Standard edits developed by national organizations
Hospital Cancer Registries
Data Produced
• ACos required studies
–
–
–
–
Requirement of ACoS approval
Site specific
Quality and outcomes focused
Patient care improvements
• Annual report
• Administrative reports
• Ad-hoc reports/requests for data
Questions Answered With Hospital
Cancer Registry Data
•
•
•
•
•
•
•
•
Who are we serving?
Where are patients coming from?
How were they referred to our facility?
Was access a problem?
How sick are they when they’re diagnosed?
How are they treated?
How well do they fare compared to others?
Do we have adequate numbers to support
various clinical trials?
American College of Surgeons –
National Cancer Database (NCDB)
• Joint program of the ACoS Commission on Cancer (CoC) and the
American Cancer Society
• Nationwide oncology outcomes database for more than 1,500
Commission-accredited cancer programs in the United States and
Puerto Rico
• 70 percent of all newly diagnosed cases of cancer in the United
States are captured at the institutional level and reported to the
NCDB
• Primarily used by CoC-accredited cancer programs as a means by
which to evaluate and compare the cancer care delivered to patients
diagnosed and/or treated at their facility with that provided at state,
regional, and national cancer facilities
Massachusetts Cancer Registry
• Population based state cancer registry
• Data from 1982
• Massachusetts Population – 2010
-
Total: 6,547,629
White: 80.4%
Black: 6.6%
American Indian/Alaskan Native: 0.3%
Asian: 5.3%
Native Hawaiian-Other Pacific Islander: 0.0%
Reporting two or more races: 2.6%
Latino or Hispanic Origin: 9.6%
White, not Hispanic: 76.1%
Massachusetts Cancer Registry
Race/Ethnicity
Mass
US
White
80.4%
72.4%
Black
6.6
12.6
American Indian and Alaska Native
0.3
0.9
Asian
5.3
4.8
Native Hawaiian and Other Pacific Islander
0.0
0.2
Persons reporting two or more races
2.6
2.9
Hispanic or Latino origin
9.6
16.3
White not Hispanic
76.1
63.7
Massachusetts Cancer Registry
• Data collected – same data items as hospital data set
• Provides the Abstracting and Coding Manual for
Hospitals
• Consolidation of information from all reporting sources
– Incidence data – each tumor (occurrence of cancer) counted
once
– Primarily reported from hospitals
– Some outpatient/path lab reporting
• Data stored at multiple levels
– Patient level data
– Tumor level data
– Treatment level data
Massachusetts Cancer Registry
Patient A
Name
Address
Age etc.
Tumor 1
Site
Histology
Stage etc.
Treatment A
CTX
Treatment B
Surgery
Tumor 2
Site
Histology
Stage, etc.
Treatment A
CTX
Treatment B
XRT
Massachusetts Cancer Registry
Consolidation Process
• Algorithms to dictate
– Match
– Non-match
– Review
• Consolidation rules
• Multiple primary rules
– Lymphomas and leukemias
– Laterality
– Benign vs. malignant
Massachusetts Cancer Registry
Consolidation Process
Patient A
Hospital 1
Patient A
Hospital 2
Name: Jones
Name: Jonnes
Primary Site: LLL Lung
Histology: Small cell
Primary Site: LUL Lung
Histology: Adenoca
Massachusetts Cancer Registry
Consolidation Process
Hospital A
Name: Jones
Primary site: LLL Lung
Histology: Small Cell
Consolidated Patient
Record
Name: Jones
Consolidated
Tumor Record
Site: LLL Lung
Histology: Adneoca
Hospital B
Name: Jonnes
Primary site: LUL Lung
Histology Adenoca
Massachusetts Cancer Registry
Consolidation Process
• Very time consuming!
• Always looking for ways to further automate
• Also involves real-time edit resolution
– Males with endometrial ca
– Impossible/rare site-histology combinations
– Age flags
Massachusetts Cancer Registry
Data - Reports
• Two main reports:
– Cancer Incidence and Mortality in Massachusetts
– The City/Town Supplement
• Special reports
– Cervical and Uterine Cancers in MA
– Cancer Incidence and Mortality in Boston
Neighborhoods
– Childhood Cancers in MA
– Cancer in MA by Race and Ethnicity
– … and more on their website
Massachusetts Cancer Registry
Data - Reports
• MassCHIP - Massachusetts Community Health
Information Profile
– Online access to health and social indicators
– http://www.mass.gov/dph/masschip
• Linkages and data requests
– Linkages with data sets provided to them
– Approval for all data requests by the MDPH
Human Research Review Committee
Massachusetts Cancer Registry
Data - Reports
• MCR website:
www.mass.gov/dph/mcr
Questions Answered With
Massachusetts Cancer Registry Data
• What is the race, gender, age breakdown for
cancers in the state?
• What do certain areas look like in terms of
cancer type and demographic variables?
• How does our hospital population compare to
the state in terms of stage at diagnosis?
• Are there sufficient numbers of patients to justify
a new service or to open a trial?
North American Association of Central
Cancer Registries
• Promotes uniform data standards
• Provides education and training; certifies
population-based registries
• Gold and Silver status
• Aggregates and publishes data from central
cancer registries
• Promotes the use of cancer surveillance data
North American Association of Central
Cancer Registries
• All central cancer registries in the United States
and Canada are members
• Cancer In North America (CINA)
• Published annually
• Contains: general demographic information about
each state, data quality indicators, site specific
incidence rates
• Individual states
• US Combined Report
North American Association of Central
Cancer Registries - Reports
•
•
•
•
•
Cancer Incidence in North America (CINA) Monographs - four published
volumes of cancer statistics for a five-year period
CINA+ Online - an on-line query system utilizing CINA data
CINA Monograph Data in SAS Data Set - published data in CINA
Monograph (all four volumes) available for use in SAS
CINA Plus in SEER*Stat - data from CINA+ Online that are available in
SEER*Stat software, allowing more flexible queries and statistical testing.
Only available to NAACCR members or collaborators with NAACCR
members.
CINA Deluxe - a multi-registry NAACCR members analytical data file for
cancer researchers that includes more detailed data variables and
groupings. Only available to NAACCR members or collaborators with
NAACCR members.
CDC National Program of Cancer
Registries (NPCR)
• Established by Congress through the Cancer
Registries Amendment Act in 1992
• Provided funding, supplemental and start up, to
state cancer registries
• Contracted with NAACCR to provide guidance in
the areas of data standards and quality control
• In collaboration with the NAACCR, produce the
United States Cancer Statistics: Incidence and
Mortality report
NPCR - Program Contacts by Funding
Status
NCI SEER
• Data from 18 population based central cancer registries
• Covers approximately 26% of the US population
• 23.4% of Whites
• 22.7% of African Americans
• 40.4% of Hispanics
• 42.2% of American Indians and Alaska Natives
• 53.3% of Asians
• 69.8% Hawaiian/Pacific Islanders
NCI SEER
NCI SEER
NCI SEER
Goals of the SEER Program
• Collect data
• Conduct quality control and quality improvement
programs
• Report on the cancer burden in selected segments of the
population
• Identify unusual changes and differences in patterns of
occurrence
• Describe temporal changes in the extent of disease at
diagnosis, trends in therapy and changes in survival
• Monitor the occurrence of possible cancers that are
caused by cancer therapy
NCI SEER
Goals of the SEER Program
• Collaborate with other organizations on cancer
surveillance activities, data standards and training
• Serve as a research resource to the NCI regarding
studies dealing with cancer prevention and control,
program and registry operations
• Provide research resources to the general research
community
• Provide training materials and web-based training
resources to the cancer registry community.
NCI SEER
Data Available
• SEER data are updated annually
• Provided in print and electronic formats
• SEER web site (http://seer.cancer.gov)
• Reports on cancer statistics
• Instructions on how to access the SEER public use file free of
charge on a CD-ROM or access provided through a server at
NCI.
• Software provided free of charge by NCI that aids in the
analysis of the SEER database (SEER*Stat) and can be used to
analyze data from other cancer registries (SEER*Prep and
SEER*Stat).
NCI SEER
Data Available
Three major categories of data:
1.
Cancer Statistics
Web-based systems provide access to statistical tables, graphs, and
maps from various data sources.
2.
Datasets and Software
Use SEER data to address multiple issues, such as looking at ne
stage at diagnosis by race/ethnicity, calculating survival by stage at
diagnosis, age at diagnosis, and grade or size of tumor, or
determining trends and incidence rates of cancers at various sites
over time.
3.
Publications
The statistical publications provided were produced by the SEER
program or through collaborative efforts between SEER and other
organizations.
NCI SEER
Data Available – Cancer Statistics
• Cancer Stat Fact Sheets
Printable summaries of the latest cancer statistics for major cancer
types.
• Cancer Statistics Review (CSR), 1975-2008
Detailed report published annually to present a broad profile of
cancer statistics to the public.
• Fast Stats
Build your own tables and graphs of key SEER and US cancer
statistics.
• Cancer Query Systems
Provides more flexibility and a larger set of cancer statistics than
Fast Stats but requires more input from the user.
• State Cancer Profiles
Dynamic maps and graphs enabling the investigation of cancer
trends at the county, state, and national levels
NCI SEER
Data Available – Datasets and Software
• SEER*Stat version 7.0.5 (09/26/2011)
– Statistical software that provides a convenient, intuitive
mechanism for the analysis of SEER and other cancer-related
databases. It is a powerful personal computer tool to produce
statistics for studying the impact of cancer on a population.
• SEER*Prep software version 2.4.5 (2/7/2011)
– Software that converts user-supplied ASCII text data files to the
SEER*Stat database format, allowing analysis of populationbased registry data using SEER*Stat.
• Health Disparities Calculator (HD*Calc) version 1.1.0 (01/13/2010)
– An extension of SEER*Stat designed to generate multiple
summary measures to evaluate and monitor health disparities.
NCI SEER
Data Available – Publications
• Statistical Reports
– SEER Cancer Statistics Review (CSR)
– Annual Report to the Nation on the Status of Cancer
– Cancer Incidence and Mortality Patterns among Specific Asian and
Pacific Islander Populations in the US
– United States Cancer Statistics: Cancer Incidence and Mortality Data
• Monographs (recent)
– An Update on Cancer in American Indians and Alaska Natives, 19992004
– Selected Comparisons of Measures of Health Disparities: A Review
Using Databases Relevant to Healthy People 2010 Cancer-Related
Objectives
– SEER Survival Monograph: Cancer Survival Among Adults: US SEER
Program, 1988-2001, Patient and Tumor Characteristics
NCI SEER
Linked Databases
• SEER-Medicare Linked Database
Links SEER and Medicare data.
• SEER-Medicare Health Outcomes Survey Linked Database
Links SEER and the Medicare Health Outcomes Survey (MHOS)
that provides information about the health-related quality of life
(HRQOL) of Medicare Advantage Organization (MAO) enrollees.
• National Longitudinal Mortality Study (NLMS) and Linked
SEER-NLMS Databases
SEER registry cancer patient records for 1973-2003 are linked
with the NLMS database, which was developed to examine the
relationships between self-reported demographic and
socioeconomic characteristics and mortality among a
representative sample of the US non-institutionalized population.
NCI SEER
Linked Databases – SEER-Medicare
SEER data
Clinical, demographic and cause
of death information for
persons with cancer
Medicare claims data
Covered health care services
from the time of a person's
Medicare eligibility until death
Unique population-based
source of information
Epidemiological and health
services research
Why link the SEER-Medicare Data?
The linked data can be used for a number of analyses that span the
course of cancer control activities
Diagnosis/ Tx 
Survivorship 
Second Occurrence  Terminal Care
Patterns of care
Late effects of
treatment
Rates of second
primaries
Use of hospice
services
Post-diagnostic
surveillance
Relationship of
second events to
initial treatment and
ongoing
surveillance
Patterns of care
during the last
year of life
Peri-operative
complications
Volume outcomes
studies
Extent of staging
Treatment of
prevalent cancers
Comorbidities
Survival
Source: Warren, NAACCR,NCI
SEER-Medicare Data
• SEER Data
– Incidence, site, stage, initial tx, demographics and
vital status
• Medicare claims
–
–
–
–
Short stay hospitals
Physician and lab services
Hospital outpatient claims
Home health and hospice bills
Source: Warren, NAACCR,NCI
SEER-Medicare Data
• Limitations
– Non-covered Medicare services are not
included
– Reasons for ordering tests and test results
are not included
– Primarily over 65 population
NCI SEER
SEER – RTR Program
• Residual Tissue Repository (RTR) Program
Established in 2003, the RTR maintains bio specimens
obtained from three of SEER’s population-based cancer
registries: Iowa, Hawaii, and Los Angeles. Investigators
at government, academic, and nonprofit institutions may
apply to the program to obtain specimens to study
biomarkers, etiology, and other aspects with a
population-based sample of cancer cases.
Questions Answered With NAACCR and
SEER data
• How is Massachusetts similar or different than
other parts of the country?
• How does Massachusetts compare in terms of
age at diagnosis, stage and outcomes?
• Where else might there be special populations
or rare cancers of interest?
• Where might there be the potential for
collaboration regarding these populations?
International Agency for Research on
Cancer - IARC
• WHO
• Data held and managed by the Section on
Cancer Information (CIN) of IARC
• Cancer in Five Continents
– Published every year since 1966
• CIN Website – CANCERMondial
http://www-dep.iarc.fr/
IARC
• CIN Databases
– GLOBCAN
provides access to the most recent estimates (for 2008) of the
incidence of, and mortality from 27 major cancers worldwide.
– CI5-Cancer Incidence in Five Continents
provides access to detailed information on the incidence of
cancer recorded by cancer registries (regional or national)
worldwide.
– ACCIS (Automated Childhood Cancer Information System)
provides access to data on cancer incidence and survival of
children collected by European cancer registries.
IARC
• CIN Databases (cont.)
– ECO (European Cancer Observatory)
provides access to the estimates (for 2008) of the incidence of, and
mortality from 25 major cancers in the countries of the European Union
(EU-27), together with a quick overview of on-going programmes of
screening for breast, cervical and colorectal cancers implemented in the
27 European countries.
– NORDCAN
presents up-to-date long time series of cancer incidence, mortality,
prevalence and survival from 40 cancers recorded by the Nordic
countries, together with advanced prediction facilities.
– SurvCan
presents cancer survival data from cancer registries in low and middle
income regions of the world. (Africa, Asia, the Caribbean and Central
America)
Questions Answered With IARC data
• How is the US, MA, Boston similar or
different than other parts of the country?
• Where else might there be special
populations or rare cancers of interest?
• Where might there be the potential for
collaboration regarding these populations?
Rapid Case Ascertainment
• Provides the ability to identify cancer cases
shortly after diagnosis
• Central registry editing and consolidation can be
time consuming
• Located within central cancer registries and/or at
academic medical centers
Rapid Case Ascertainment
Value to researchers: provides immediate access
to patients
• Interview patients prior to surgery
• Obtain blood/DNA etc.
• Initiate a series of questionnaires over time (i.e. 3, 6 and
9 months after diagnosis)
• Interview patients about lifestyle elements that might tend
to change after diagnosis (alcohol consumption, smoking
history)
SEER Rapid Response Surveillance
Studies
• Began as Patterns of Care Studies
• Evolved into a mechanism that allows studies to move from
the initial concept through completion in a relatively short
interval, usually within two years
• Studies address new and emerging issues related to cancer
prevention and control
• Conducted through he SEER Registries
• Largely pathology based active case-finding (e-path or circuit
riding) vs. waiting for reports to be sent to the central registry
Limitations of Using Cancer Registry Data
• Limited data set – extensive, but limited
• Strict rules for data collection – good, but
restrictive
• Time delays – data can be 1 to 2 years old
• Data collected and defined by the priorities of
others
• Dataset designed by committee
Limitations of Using Cancer Registry Data
• Reliance on primarily pathology based case-finding –
image and lab based dx’s may not be as readily picked
up (pancreas, brain, multiple myeloma)
• Majority of cases reported by hospitals – some lab and
outpatient reporting
• Data can be limited by information captured only through
the hospital system
• Outpatient information is often missing – XRT at
freestanding centers, CTX in MD offices
Limitations of Using Cancer Registry Data
• Lack of information about events leading up to
dx – screenings, health behaviors
• Limited information about co-morbid conditions
• Follow-up information often limited to vital status
– no detailed information on side effects to tx, tx
compliance
• Very little information about recurrence of
disease
Medical Record Review
• Advantages
– Flexibility
– Timeliness
– Customized data set
– Investigator control
Medical Record Review – Recent
Examples
• Helping Ourselves Helping Others
PI: Ann Partridge, MD
Breast cancer in women 40 and under
Captured within 16 weeks of dx
Cases identified and reviewed at DFCI, MGH,
BWH, NWH, Faulkner, BIDMC, North Shore
Cancer Center, Lowell General
Medical Record Review – Recent
Examples
• The Environment, Genes and Testicular Cancer
PI: Russ Hauser, MD
Newly diagnosed cases of testicular cancer
Identified shortly after dx at DFCI, MGH,
BWH, Faulkner, North Shore, BIDMC, Boston
Medical Center, Lowell General, Tufts-NEMC
Medical Record Review – Process
• Plan data set with investigator/study team
– Define data elements and data definitions
(coded 1, 2 responses vs. yes, no)
– Think about the future
• Will this data be linked or compared to other data
sets – should race and ethnicity be collected using
cancer registry/census rules
• What is being measured – can’t evaluate data that
hasn’t been collected
Medical Record Review – Process
• Design/program the data collection tool
– Access, Excel, other programs
– Consider output – where is the data goingother databases, are the variables the same
Medical Record Review – Process
• Define rules for:
– Missing data
– Incomplete data
– Illegible data
• Keep in mind
– Medical records are not designed for
research, there are limits to what they contain
Medical Record Review – Process
• Develop case identification procedures
– Review eligibility criteria
– Identify facilities
– Case sources
•
•
•
•
Pathology
Radiology
New patient admission/visits
Clinic logs
– Access to case sources
• Who has access
• How does one obtain access
• Is training required
Medical Record Review – Process
• Consider the frequency of data collection
– Is time to dx important
– Are there other patient or patient flow events to
consider
• How often do patients come in for treatment
• Do they stay in the hospital
• Is there a planned schedule of testing
– Many cases will need to be reviewed to find eligible
cases – this can be time consuming
Medical Record Review – Process
• Work with investigator/study team on IRB issues
– Provide background information on personnel
– Provide information about methods for identifying
cases
• Build in quality control measures
– Computerized edits
– Double abstraction (5-10%, inter rater reliability > 95%)
Abstraction Process
Research Hypothesis
Define
Variables
Guidelines
Staff
Revisions
Exploration
Instrument
Development
Logic checks
Default values
Pilot testing
Plans for Case
Identification
Record review
Quality Mgmt
Adapted from Keyzer, UC Davis
What Would They Think?
Progress
• Amount of work in Outcomes Research
• Focus on End Results Reporting, particularly
Comparative Effectiveness Research
• Accountability
• Evidence based practices
• Research based interventions
Questions?
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